m III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.~nicotine: Given transdermally and orally"
1010740|NCT00790569|B2|Baseline|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~placebo: Given orally"
1010741|NCT00790569|B1|Baseline|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~varenicline: Given orally"
1010742|NCT00790569|P3|Participant Flow|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.~nicotine: Given transdermally and orally"
1010743|NCT00790569|P2|Participant Flow|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~placebo: Given orally"
1010744|NCT00790569|P1|Participant Flow|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~varenicline: Given orally"
1010745|NCT00790569|O3|Outcome|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.~nicotine: Given transdermally and orally"
1010746|NCT00790569|O2|Outcome|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~placebo: Given orally"
1010747|NCT00790569|O1|Outcome|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~varenicline: Given orally"
1010748|NCT00790569|O3|Outcome|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.~nicotine: Given transdermally and orally"
1010749|NCT00790569|O2|Outcome|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~placebo: Given orally"
1010750|NCT00790569|O1|Outcome|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~varenicline: Given orally"
1010751|NCT00790569|O3|Outcome|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.~nicotine: Given transdermally and orally"
1010752|NCT00790569|O2|Outcome|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~placebo: Given orally"
1010753|NCT00790569|O1|Outcome|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~varenicline: Given orally"
1010754|NCT00790569|O3|Outcome|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.~nicotine: Given transdermally and orally"
1010755|NCT00790569|O2|Outcome|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~placebo: Given orally"
1010756|NCT00790569|O1|Outcome|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~varenicline: Given orally"
1010757|NCT00790569|O3|Outcome|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.~nicotine: Given transdermally and orally"
1010758|NCT00790569|O2|Outcome|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~placebo: Given orally"
1010759|NCT00790569|O1|Outcome|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~varenicline: Given orally"
1010760|NCT00790569|O3|Outcome|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.~nicotine: Given transdermally and orally"
1010761|NCT00790569|O2|Outcome|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~placebo: Given orally"
1010762|NCT00790569|O1|Outcome|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~varenicline: Given orally"
1010763|NCT00790569|E3|Reported Event|Arm III|"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.~nicotine: Given transdermally and orally"
1010764|NCT00790569|E2|Reported Event|Arm II|"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~placebo: Given orally"
1010765|NCT00790569|E1|Reported Event|Arm I|"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.~varenicline: Given orally"
1010766|NCT00790556|B1|Baseline|All Participants|All participants
1010810|NCT00790400|O3|Outcome|Everolimus (Core and/or Extension Period)|Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
1020874|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
1010767|NCT00790556|P2|Participant Flow|Placebo Then MK8245|"During Treatment Period 1, these subjects received MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~During Treatment Period 2, these subjects received MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14."
1010768|NCT00790556|P1|Participant Flow|MK8245 Then Placebo|"During Treatment Period 1, these subjects received MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~During Treatment Period 2, these subjects received MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14."
1010769|NCT00790556|O2|Outcome|Placebo|"MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~Includes results of this treatment from both treatment periods."
1010770|NCT00790556|O1|Outcome|MK8245|"MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~Includes results of this treatment from both treatment periods."
1010771|NCT00790556|O2|Outcome|Placebo|"MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~Includes results of this treatment from both treatment periods."
1010772|NCT00790556|O1|Outcome|MK8245|"MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~Includes results of this treatment from both treatment periods."
1010773|NCT00790556|O2|Outcome|Placebo|"MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~Includes results of this treatment from both treatment periods."
1010774|NCT00790556|O1|Outcome|MK8245|"MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~Includes results of this treatment from both treatment periods."
1010775|NCT00790556|E2|Reported Event|Placebo|"MK-8245 matching placebo twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~Includes results of this treatment from both treatment periods."
1010776|NCT00790556|E1|Reported Event|MK8245|"MK-8245 50 mg twice daily 12 hours apart for 13 days, only the AM dose was administered on Day 14.~Includes results of this treatment from both treatment periods."
1010777|NCT00790452|B3|Baseline|Total|Total of all reporting groups
1010778|NCT00790452|B2|Baseline|Group 2 (Placebo)|Tablet/day orally
1010779|NCT00790452|B1|Baseline|Group 1 (Aspirin)|Aspirin 325 mg/day orally
1010780|NCT00790452|P2|Participant Flow|Group 2 (Placebo)|Tablet/day orally
1010781|NCT00790452|P1|Participant Flow|Group 1 (Aspirin)|Aspirin 325 mg/day orally
1010782|NCT00790452|O2|Outcome|Group 2 (Placebo)|Tablet/day orally
1010783|NCT00790452|O1|Outcome|Group 1 (Aspirin)|Aspirin 325 mg/day orally
1010784|NCT00790452|E2|Reported Event|Group 2 (Placebo)|Tablet/day orally
1010785|NCT00790452|E1|Reported Event|Group 1 (Aspirin)|Aspirin 325 mg/day orally
1010786|NCT00790400|B3|Baseline|Total|Total of all reporting groups
1010787|NCT00790400|B2|Baseline|Placebo|Placebo was given by continuous oral daily dosing of two 5 mg tablets.
1010788|NCT00790400|B1|Baseline|Everolimus|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
1010789|NCT00790400|P2|Participant Flow|Placebo|Placebo was given by continuous oral daily dosing of two 5 mg tablets.
1010790|NCT00790400|P1|Participant Flow|Everolimus|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
1010791|NCT00790400|O2|Outcome|Everolimus (Core and/or Extension Period)|Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
1010792|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
1010793|NCT00790400|O2|Outcome|Everolimus (Core and/or Extension Period)|Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
1010794|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
1010795|NCT00790400|O2|Outcome|Everolimus (Core and/or Extension Period)|Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
1010796|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
1010797|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
1010798|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
1010799|NCT00790400|O2|Outcome|Placebo Randomized (Core Period)|Placebo was given by continuous oral daily dosing of two 5 mg tablets.
1010800|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
1010801|NCT00790400|O3|Outcome|Everolimus (Core and/or Extension Period)|Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
1010802|NCT00790400|O2|Outcome|Placebo Randomized (Core Period)|Placebo was given by continuous oral daily dosing of two 5 mg tablets.
1010803|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
1010804|NCT00790400|O3|Outcome|Everolimus (Core and/or Extension Period)|Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
1010805|NCT00790400|O2|Outcome|Placebo Randomized (Core Period)|Placebo was given by continuous oral daily dosing of two 5 mg tablets.
1010806|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
1010807|NCT00790400|O3|Outcome|Everolimus (Core and/or Extension Period)|Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
1010808|NCT00790400|O2|Outcome|Placebo Randomized (Core Period)|Placebo was given by continuous oral daily dosing of two 5 mg tablets.
1010809|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
1011000|NCT00790023|O3|Outcome|Placebo|Placebo once daily
1010811|NCT00790400|O2|Outcome|Placebo Randomized (Core Period)|Placebo was given by continuous oral daily dosing of two 5 mg tablets.
1010812|NCT00790400|O1|Outcome|Everolimus Randomized (Core Period)|Study drug was given by continuous oral daily dosing of two 5 mg tablets.
1010813|NCT00790400|E3|Reported Event|Placebo Randomized/Never Crossed-over|Patients randomized to placebo who never crossed-over to Everolimus
1010814|NCT00790400|E2|Reported Event|Placebo Randomized/Crossed Over to Everolimus|Patients who were randomized to placebo in the Core phase and who crossed-over to Everolimus in the Extension phase
1010815|NCT00790400|E1|Reported Event|Everolimus Randomized (Core & Ext)|Patients who were randomized and treated with Everolimus during the Core and Extension phase
1010816|NCT00790296|B3|Baseline|Total|Total of all reporting groups
1010817|NCT00790296|B2|Baseline|Saline Then TRH|Saline given first followed by TRH (0.5 mg)
1010818|NCT00790296|B1|Baseline|TRH Then Saline|TRH (0.5mg) given first followed by Saline
1010819|NCT00790296|P2|Participant Flow|Saline Then TRH|Saline given first followed by TRH (0.5 mg)
1010820|NCT00790296|P1|Participant Flow|TRH Then Saline|TRH (0.5mg) given first followed by Saline
1010821|NCT00790296|O2|Outcome|Saline|Saline given Intravenously
1010822|NCT00790296|O1|Outcome|Thyrotropin-releasing Hormone (TRH)|TRH given as 0.5mg and 1.5mg intravenously
1010823|NCT00790296|E2|Reported Event|Saline|Saline given intravenously
1010824|NCT00790296|E1|Reported Event|Thyrotropin-releasing Hormone (TRH)|TRH given as 0.5mg and 1.5mg intravenously
1010825|NCT00790270|B4|Baseline|Total|Total of all reporting groups
1010826|NCT00790270|B3|Baseline|Ibuprophen Plus Cyclobenzaprine|
1010827|NCT00790270|B2|Baseline|Ibuprofen|
1010828|NCT00790270|B1|Baseline|Cyclobenzaprine|
1010829|NCT00790270|P3|Participant Flow|Ibuprophen Plus Cyclobenzaprine|
1010830|NCT00790270|P2|Participant Flow|Ibuprofen|
1010831|NCT00790270|P1|Participant Flow|Cyclobenzaprine|
1010832|NCT00790270|O3|Outcome|Ibuprophen Plus Cyclobenzaprine|
1010833|NCT00790270|O2|Outcome|Ibuprofen|
1010834|NCT00790270|O1|Outcome|Cyclobenzaprine|
1010835|NCT00790270|O3|Outcome|Ibuprophen Plus Cyclobenzaprine|
1010836|NCT00790270|O2|Outcome|Ibuprofen|
1010837|NCT00790270|O1|Outcome|Cyclobenzaprine|
1010838|NCT00790270|E3|Reported Event|Ibuprophen Plus Cyclobenzaprine|
1010839|NCT00790270|E2|Reported Event|Ibuprofen|
1010840|NCT00790270|E1|Reported Event|Cyclobenzaprine|
1010841|NCT00790218|B1|Baseline|CF102|CF102: CF102 capsules twice daily by mouth
1010842|NCT00790218|P3|Participant Flow|CF102 25mg|CF102: CF102 tablets were given orally twice daily
1010843|NCT00790218|P2|Participant Flow|CF102 5mg|CF102: CF102 tablets were given orally twice daily
1010844|NCT00790218|P1|Participant Flow|CF102 1mg|CF102: CF102 tablets were given orally twice daily
1010845|NCT00790218|O3|Outcome|CF102 25mg|CF102 tablets given orally, BID
1010846|NCT00790218|O2|Outcome|CF102 5mg|CF102 tablets given orally, BID
1010847|NCT00790218|O1|Outcome|CF102 1mg|CF102 tablets given orally, BID
1010848|NCT00790218|E3|Reported Event|CF102 25mg|CF102: CF102 capsules twice daily by mouth
1010849|NCT00790218|E2|Reported Event|CF102 5mg|CF102: CF102 capsules twice daily by mouth
1010850|NCT00790218|E1|Reported Event|CF102 1mg|CF102: CF102 capsules twice daily by mouth
1010851|NCT00790205|B3|Baseline|Total|Total of all reporting groups
1010852|NCT00790205|B2|Baseline|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
1010853|NCT00790205|B1|Baseline|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
1010854|NCT00790205|P2|Participant Flow|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
1010855|NCT00790205|P1|Participant Flow|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
1010856|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
1010857|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
1010858|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
1010859|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
1010860|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
1010861|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
1010862|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
1010863|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
1010864|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
1010865|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
1010866|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
1010867|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
1010868|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
1010869|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
1010870|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
1010871|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
1010872|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
1011001|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
1010873|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
1010874|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
1010875|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
1010876|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
1010877|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
1010878|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
1010879|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
1010880|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
1010881|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
1010882|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
1010883|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
1010884|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
1010885|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
1010886|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
1010887|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
1010888|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
1010889|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
1010890|NCT00790205|O2|Outcome|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
1010891|NCT00790205|O1|Outcome|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
1010892|NCT00790205|E2|Reported Event|Placebo|Matching placebo tablet taken orally once daily in the morning for up to approximately 5 years
1010893|NCT00790205|E1|Reported Event|Sitagliptin|Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years
1010894|NCT00790192|B5|Baseline|Total|Total of all reporting groups
1010895|NCT00790192|B4|Baseline|Placebo|Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to >= 5%.
1010896|NCT00790192|B3|Baseline|Quetiapine XR 600mg|Quetiapine XR 600 mg (4 tablets) orally taken once a day
1010897|NCT00790192|B2|Baseline|Lurasidone 160 mg|Lurasidone 160 mg (4 tablets) taken orally once a day
1010898|NCT00790192|B1|Baseline|Lurasidone 80 mg|Lurasidone 80 mg tablets taken orally once a day
1010899|NCT00790192|P4|Participant Flow|Placebo|Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to >= 5%.
1010900|NCT00790192|P3|Participant Flow|Quetiapine XR 600mg|Quetiapine XR 600 mg (4 tablets) orally taken once a day
1010901|NCT00790192|P2|Participant Flow|Lurasidone 160 mg|Lurasidone 160 mg (4 tablets) taken orally once a day
1010902|NCT00790192|P1|Participant Flow|Lurasidone 80 mg|Lurasidone 80 mg tablets taken orally once a day
1010903|NCT00790192|O4|Outcome|Placebo|Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to >= 5%.
1010904|NCT00790192|O3|Outcome|Quetiapine XR 600mg|Quetiapine XR 600 mg (4 tablets) orally taken once a day
1010905|NCT00790192|O2|Outcome|Lurasidone 160 mg|Lurasidone 160 mg (4 tablets) taken orally once a day
1010906|NCT00790192|O1|Outcome|Lurasidone 80 mg|Lurasidone 80 mg tablets taken orally once a day
1010907|NCT00790192|O4|Outcome|Placebo|Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to >= 5%.
1010908|NCT00790192|O3|Outcome|Quetiapine XR 600mg|Quetiapine XR 600 mg (4 tablets) orally taken once a day
1010909|NCT00790192|O2|Outcome|Lurasidone 160 mg|Lurasidone 160 mg (4 tablets) taken orally once a day
1010910|NCT00790192|O1|Outcome|Lurasidone 80 mg|Lurasidone 80 mg tablets taken orally once a day
1010911|NCT00790192|E4|Reported Event|Placebo|Matching placebo to either lurasidone or quetiapine XR. The total for this group is 73 and the adverse events only add up to 69 because the total is based on all treatment emergent adverse events not limited to >= 5%.
1010912|NCT00790192|E3|Reported Event|Quetiapine XR 600mg|Quetiapine XR 600 mg (4 tablets) orally taken once a day
1010913|NCT00790192|E2|Reported Event|Lurasidone 160 mg|Lurasidone 160 mg (4 tablets) taken orally once a day
1010914|NCT00790192|E1|Reported Event|Lurasidone 80 mg|Lurasidone 80 mg tablets taken orally once a day
1010915|NCT00790062|B4|Baseline|Total|Total of all reporting groups
1010916|NCT00790062|B3|Baseline|Oxytocin 80U/500cc|
1010917|NCT00790062|B2|Baseline|Oxytocin 40 Units/500cc|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
1010918|NCT00790062|B1|Baseline|Oxytocin 10 Units/500cc|
1010919|NCT00790062|P3|Participant Flow|Oxytocin 80U/500cc|
1010920|NCT00790062|P2|Participant Flow|Oxytocin 40 Units/500cc|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
1010921|NCT00790062|P1|Participant Flow|Oxytocin 10 Units/500cc|
1010922|NCT00790062|O3|Outcome|Oxytocin 80U/500cc|"1 dose only given over 1 hour~Oxytocin: See arms"
1010923|NCT00790062|O2|Outcome|Oxytocin 40 Units/500cc|"One dose only given over 1 hour. Per DSMB recommendations, this intermediate arm was stopped Jan 2010.~Oxytocin: See arms"
1010924|NCT00790062|O1|Outcome|Oxytocin 10 Units/500cc|"1 dose only for prophylaxis given over 1 hour~Oxytocin: See arms"
1010925|NCT00790062|O3|Outcome|Oxytocin 80U/500cc|
1010926|NCT00790062|O2|Outcome|Oxytocin 40 Units/500cc|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
1010927|NCT00790062|O1|Outcome|Oxytocin 10 Units/500cc|
1010928|NCT00790062|O3|Outcome|Oxytocin 80U/500cc|
1010929|NCT00790062|O2|Outcome|Oxytocin 40 Units/500cc|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
1010930|NCT00790062|O1|Outcome|Oxytocin 10 Units/500cc|
1010931|NCT00790062|O3|Outcome|Oxytocin 80U/500cc|
1010932|NCT00790062|O2|Outcome|Oxytocin 40 Units/500cc|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
1010933|NCT00790062|O1|Outcome|Oxytocin 10 Units/500cc|
1010934|NCT00790062|O3|Outcome|Oxytocin 80U/500cc|
1010935|NCT00790062|O2|Outcome|Oxytocin 40 Units/500cc|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
1010936|NCT00790062|O1|Outcome|Oxytocin 10 Units/500cc|
1010937|NCT00790062|O3|Outcome|Oxytocin 80U/500cc Over 1 Hour|
1010938|NCT00790062|O2|Outcome|Oxytocin 40 Units/500cc Over 1 Hour|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
1010939|NCT00790062|O1|Outcome|Oxytocin 10 Units/500cc Over 1 Hour|
1010940|NCT00790062|O3|Outcome|Oxytocin 80U/500cc|"1 dose only given over 1 hour~Oxytocin: See arms"
1010941|NCT00790062|O2|Outcome|Oxytocin 40 Units/500cc|"One dose only given over 1 hour. Per DSMB recommendations, this intermediate arm was stopped Jan 2010.~Oxytocin: See arms"
1010942|NCT00790062|O1|Outcome|Oxytocin 10 Units/500cc|"1 dose only for prophylaxis given over 1 hour~Oxytocin: See arms"
1010943|NCT00790062|O3|Outcome|Oxytocin 80U/500cc|1 dose only for prophylaxsis given over 1 hour
1010944|NCT00790062|O2|Outcome|Oxytocin 40 Units/500cc|"Per DSMB recommendations, this intermediate arm was stopped Jan 2010.~1 dose only for prophylaxsis given over 1 hour"
1010945|NCT00790062|O1|Outcome|Oxytocin 10 Units/500cc|1 dose only for prophylaxsis given over 1 hour
1010946|NCT00790062|E3|Reported Event|Oxytocin 80U/500cc|
1010947|NCT00790062|E2|Reported Event|Oxytocin 40 Units/500cc|Per DSMB recommendations, this intermediate arm was stopped Jan 2010.
1010948|NCT00790062|E1|Reported Event|Oxytocin 10 Units/500cc|
1010949|NCT00790023|B4|Baseline|Total|Total of all reporting groups
1010950|NCT00790023|B3|Baseline|Placebo|Placebo once daily
1010951|NCT00790023|B2|Baseline|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
1010952|NCT00790023|B1|Baseline|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
1010953|NCT00790023|P3|Participant Flow|Placebo|Placebo once daily
1010954|NCT00790023|P2|Participant Flow|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
1010955|NCT00790023|P1|Participant Flow|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
1010956|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
1010957|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
1010958|NCT00790023|O3|Outcome|Placebo|Placebo once daily
1010959|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
1010960|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
1010961|NCT00790023|O3|Outcome|Placebo|
1010962|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
1010963|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
1010964|NCT00790023|O3|Outcome|Placebo|Placebo once daily
1010965|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
1010966|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
1010967|NCT00790023|O3|Outcome|Placebo|Placebo once daily
1010968|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
1010969|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
1010970|NCT00790023|O3|Outcome|Placebo|Placebo once daily
1010971|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
1010972|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
1010973|NCT00790023|O3|Outcome|Placebo|Placebo once daily
1010974|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
1010975|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
1010976|NCT00790023|O3|Outcome|Placebo|Placebo once daily
1010977|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
1010978|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
1010979|NCT00790023|O3|Outcome|Placebo|Placebo once daily
1010980|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
1010981|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
1010982|NCT00790023|O3|Outcome|Placebo|Placebo once daily
1010983|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
1010984|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
1010985|NCT00790023|O3|Outcome|Placebo|Placebo once daily
1010986|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
1010987|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
1010988|NCT00790023|O3|Outcome|Placebo|Placebo once daily
1010989|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
1010990|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
1010991|NCT00790023|O3|Outcome|Placebo|Placebo once daily
1010992|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
1010993|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
1010994|NCT00790023|O3|Outcome|Placebo|Placebo once daily
1010995|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
1010996|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
1010997|NCT00790023|O3|Outcome|Placebo|Placebo once daily
1010998|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
1010999|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
1011005|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
1011006|NCT00790023|O3|Outcome|Placebo|Placebo once daily
1011007|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
1011008|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
1011009|NCT00790023|O3|Outcome|Placebo|Placebo once daily
1011010|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
1011011|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
1011012|NCT00790023|O3|Outcome|Placebo|Placebo once daily
1011013|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
1011014|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
1011015|NCT00790023|O3|Outcome|Placebo|Placebo once daily
1011016|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
1011017|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
1011018|NCT00790023|O3|Outcome|Placebo|Placebo once daily
1011019|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
1011020|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
1011021|NCT00790023|O3|Outcome|Placebo|Placebo once daily
1011022|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
1011023|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
1011024|NCT00790023|O3|Outcome|Placebo|Placebo once daily
1011025|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
1011026|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
1011027|NCT00790023|O3|Outcome|Placebo|Placebo once daily
1011028|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
1011029|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
1011030|NCT00790023|O3|Outcome|Placebo|Placebo once daily
1011031|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
1011032|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
1011033|NCT00790023|O3|Outcome|Placebo|Placebo once daily
1011034|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
1011035|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
1011036|NCT00790023|O3|Outcome|Placebo|Placebo once daily
1011037|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
1011038|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
1011039|NCT00790023|E3|Reported Event|Placebo|Placebo once daily
1011040|NCT00790023|E2|Reported Event|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
1011041|NCT00790023|E1|Reported Event|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
1011042|NCT00789997|B3|Baseline|Total|Total of all reporting groups
1011043|NCT00789997|B2|Baseline|Prednisone|Prednisone + Levofloxacin + placebo Etanercept subcutaneous injections : Levofloxacin 750 mg daily for 10 days + prednisone 40 mg daily for 10 days + placebo subcutaneous injections given on day of randomization and one week later.
1011044|NCT00789997|B1|Baseline|Etanercept|Etanercept + Levofloxacin + placebo prednisone capsules : Levofloxacin 750 mg daily for 10 days + etanercept 50 mg subcutaneous given on the day of randomization and one week later + placebo prednisone capsule, 1 daily for 10 days.
1011045|NCT00789997|P2|Participant Flow|Prednisone|Prednisone + Levofloxacin + placebo Etanercept subcutaneous injections : Levofloxacin 750 mg daily for 10 days + prednisone 40 mg daily for 10 days + placebo subcutaneous injections given on day of randomization and one week later.
1011046|NCT00789997|P1|Participant Flow|Etanercept|Etanercept + Levofloxacin + placebo prednisone capsules : Levofloxacin 750 mg daily for 10 days + etanercept 50 mg subcutaneous given on the day of randomization and one week later + placebo prednisone capsule, 1 daily for 10 days.
1011047|NCT00789997|O2|Outcome|Prednisone|Prednisone + Levofloxacin + placebo Etanercept subcutaneous injections : Levofloxacin 750 mg daily for 10 days + prednisone 40 mg daily for 10 days + placebo subcutaneous injections given on day of randomization and one week later.
1011048|NCT00789997|O1|Outcome|Etanercept|Etanercept + Levofloxacin + placebo prednisone capsules : Levofloxacin 750 mg daily for 10 days + etanercept 50 mg subcutaneous given on the day of randomization and one week later + placebo prednisone capsule, 1 daily for 10 days.
1011049|NCT00789997|O2|Outcome|Prednisone|Prednisone + Levofloxacin + placebo Etanercept subcutaneous injections : Levofloxacin 750 mg daily for 10 days + prednisone 40 mg daily for 10 days + placebo subcutaneous injections given on day of randomization and one week later.
1011050|NCT00789997|O1|Outcome|Etanercept|Etanercept + Levofloxacin + placebo prednisone capsules : Levofloxacin 750 mg daily for 10 days + etanercept 50 mg subcutaneous given on the day of randomization and one week later + placebo prednisone capsule, 1 daily for 10 days.
1011051|NCT00789997|E2|Reported Event|Prednisone|Prednisone + Levofloxacin + placebo Etanercept subcutaneous injections : Levofloxacin 750 mg daily for 10 days + prednisone 40 mg daily for 10 days + placebo subcutaneous injections given on day of randomization and one week later.
1011052|NCT00789997|E1|Reported Event|Etanercept|Etanercept + Levofloxacin + placebo prednisone capsules : Levofloxacin 750 mg daily for 10 days + etanercept 50 mg subcutaneous given on the day of randomization and one week later + placebo prednisone capsule, 1 daily for 10 days.
1011053|NCT00789958|B1|Baseline|Adjuvant Chemotherapy + Chemoradiotherapy|"Adjuvant Chemotherapy:~Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle.~Chemoradiotherapy:~Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions."
1011076|NCT00789880|P3|Participant Flow|Vitamin D (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1011145|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
1011054|NCT00789958|P1|Participant Flow|Adjuvant Chemotherapy + Chemoradiotherapy|"Adjuvant Chemotherapy:~Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle.~Chemoradiotherapy:~Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions."
1011055|NCT00789958|O1|Outcome|Adjuvant Chemotherapy + Chemoradiotherapy|"Adjuvant Chemotherapy:~Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle.~Chemoradiotherapy:~Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions."
1011056|NCT00789958|O2|Outcome|Patients w/Microscopically Positive Margin of Resection (R1)|Eligible and analyzable patients that received a resection with microscopically positive (R1) margins.
1011057|NCT00789958|O1|Outcome|Patients With Negative Margins of Resection (R0)|Eligible and analyzable patients that received a resection with negative (R0) margins.
1011058|NCT00789958|O1|Outcome|Adjuvant Chemotherapy + Chemoradiotherapy|"Adjuvant Chemotherapy:~Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle.~Chemoradiotherapy:~Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions."
1011059|NCT00789958|O2|Outcome|Patients w/Microscopically Positive Margin of Resection (R1)|Eligible and analyzable patients that received a resection with microscopically positive (R1) margins.
1011060|NCT00789958|O1|Outcome|Patients With Negative Margins of Resection (R0)|Eligible and analyzable patients that received a resection with negative (R0) margins.
1011061|NCT00789958|O1|Outcome|Adjuvant Chemotherapy + Chemoradiotherapy|"Adjuvant Chemotherapy:~Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle.~Chemoradiotherapy:~Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions."
1011062|NCT00789958|O1|Outcome|Adjuvant Chemotherapy + Chemoradiotherapy|"Adjuvant Chemotherapy:~Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle.~Chemoradiotherapy:~Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions."
1011063|NCT00789958|O2|Outcome|Patients w/Microscopically Positive Margin of Resection (R1)|Eligible and analyzable patients that received a resection with microscopically positive (R1) margins.
1011064|NCT00789958|O1|Outcome|Patients With Negative Margins of Resection (R0)|Eligible and analyzable patients that received a resection with negative (R0) margins.
1011065|NCT00789958|E1|Reported Event|Adjuvant Chemotherapy + Chemoradiotherapy|"Adjuvant Chemotherapy:~Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle.~Chemoradiotherapy:~Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions."
1011066|NCT00789880|B7|Baseline|Total|Total of all reporting groups
1011067|NCT00789880|B6|Baseline|Placebo (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
1011068|NCT00789880|B5|Baseline|Placebo (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
1011069|NCT00789880|B4|Baseline|Placebo (Non-AD)|Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.
1011070|NCT00789880|B3|Baseline|Vitamin D (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1011071|NCT00789880|B2|Baseline|Vitamin D (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1011072|NCT00789880|B1|Baseline|Vitamin D (Non-AD)|Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily).
1011073|NCT00789880|P6|Participant Flow|Placebo (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
1011074|NCT00789880|P5|Participant Flow|Placebo (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
1011075|NCT00789880|P4|Participant Flow|Placebo (Non-AD)|Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.
1011077|NCT00789880|P2|Participant Flow|Vitamin D (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1011078|NCT00789880|P1|Participant Flow|Vitamin D (Non-AD)|Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily).
1011079|NCT00789880|O2|Outcome|Placebo (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
1011080|NCT00789880|O1|Outcome|Vitamin D (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1011081|NCT00789880|O2|Outcome|Placebo (Non-AD)|Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.
1011082|NCT00789880|O1|Outcome|Vitamin D (Non-AD)|Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily).
1011083|NCT00789880|O2|Outcome|Placebo (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
1011084|NCT00789880|O1|Outcome|Vitamin D (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1011085|NCT00789880|O2|Outcome|Placebo (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
1011086|NCT00789880|O1|Outcome|Vitamin D (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1011087|NCT00789880|O2|Outcome|Placebo (Non-AD)|Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.
1011088|NCT00789880|O1|Outcome|Vitamin D (Non-AD)|Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily).
1011089|NCT00789880|O2|Outcome|Placebo (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
1011090|NCT00789880|O1|Outcome|Vitamin D (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1011091|NCT00789880|O2|Outcome|Placebo (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
1011092|NCT00789880|O1|Outcome|Vitamin D (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1011093|NCT00789880|O2|Outcome|Placebo (Non-AD)|Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.
1011094|NCT00789880|O1|Outcome|Vitamin D (Non-AD)|Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily).
1011095|NCT00789880|O2|Outcome|Placebo (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
1011096|NCT00789880|O1|Outcome|Vitamin D (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1011097|NCT00789880|E6|Reported Event|Placebo (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
1011098|NCT00789880|E5|Reported Event|Placebo (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
1011099|NCT00789880|E4|Reported Event|Placebo (Non-AD)|Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.
1011100|NCT00789880|E3|Reported Event|Vitamin D (Psoriasis)|Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1011101|NCT00789880|E2|Reported Event|Vitamin D (AD)|Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1011102|NCT00789880|E1|Reported Event|Vitamin D (Non-AD)|Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] daily).
1011103|NCT00789854|B4|Baseline|Total|Total of all reporting groups
1011104|NCT00789854|B3|Baseline|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
1011105|NCT00789854|B2|Baseline|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
1011106|NCT00789854|B1|Baseline|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
1011107|NCT00789854|P3|Participant Flow|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
1011108|NCT00789854|P2|Participant Flow|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
1011109|NCT00789854|P1|Participant Flow|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
1011110|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
1011111|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
1011112|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
1011113|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
1011114|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
1011115|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
1011116|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
1011117|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
1011118|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
1011119|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
1011120|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
1011121|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
1011122|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
1011123|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
1011124|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
1011125|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
1011126|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
1011127|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
1011128|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
1011129|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
1011130|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
1011131|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
1011132|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
1011133|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
1011134|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
1011135|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
1011136|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
1011137|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
1011138|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
1011139|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
1011140|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
1011141|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
1011142|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
1011143|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
1011144|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
1011480|NCT00789373|B1|Baseline|Induction Pemetrexed + Cisplatin|pemetrexed plus cisplatin
1011146|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
1011147|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
1011148|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
1011149|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
1011150|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
1011151|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
1011152|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
1011153|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
1011154|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
1011155|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
1011156|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
1011157|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
1011158|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
1011159|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
1011160|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
1011161|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
1011162|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
1011163|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
1011164|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
1011165|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
1011166|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
1011167|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
1011168|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
1011169|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
1011170|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
1011171|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
1011172|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
1011173|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
1011174|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
1011175|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
1011176|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
1011177|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
1011178|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
1011179|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
1011180|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
1011181|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
1011751|NCT00788697|O2|Outcome|Offsite Reader 1 SonoVue CE-US|Offsite Reader 1 SonoVue CE-US assessment
1011182|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
1011183|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
1011184|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
1011185|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
1011186|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
1011187|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
1011188|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
1011189|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
1011190|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
1011191|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
1011192|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
1011193|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
1011194|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
1011195|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
1011196|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
1011197|NCT00789854|O3|Outcome|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
1011198|NCT00789854|O2|Outcome|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
1011199|NCT00789854|O1|Outcome|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
1011200|NCT00789854|E3|Reported Event|Add-on Lithium|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od)
1011201|NCT00789854|E2|Reported Event|Add-on Quetiapine XR|Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od)
1011202|NCT00789854|E1|Reported Event|Quetiapine XR Mono|Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
1011203|NCT00789828|B3|Baseline|Total|Total of all reporting groups
1011204|NCT00789828|B2|Baseline|Placebo (Core Period)|Participants received oral dose of placebo matching to everolimus daily.
1011205|NCT00789828|B1|Baseline|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
1011206|NCT00789828|P2|Participant Flow|Placebo|Participants received oral dose of placebo matching to everolimus daily.
1011207|NCT00789828|P1|Participant Flow|Everolimus|Participants received oral dose of everolimus 4.5 milligram/square meter (mg/m^2) daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 nanogram/millilitre (ng/mL). Dose adjustments were permitted based on safety and whole blood trough concentrations.
1011208|NCT00789828|O2|Outcome|Placebo (Core Period)|Participants received oral dose of placebo matching to everolimus daily.
1011209|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
1011210|NCT00789828|O2|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
1011211|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
1011212|NCT00789828|O2|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
1011213|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
1011214|NCT00789828|O2|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
1011215|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
1020875|NCT00766415|E2|Reported Event|Placebo|Placebo, twice daily
1011216|NCT00789828|O3|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
1011217|NCT00789828|O2|Outcome|Placebo (Core Period)|Participants received oral dose of placebo matching to everolimus daily.
1011218|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
1011219|NCT00789828|O3|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
1011220|NCT00789828|O2|Outcome|Placebo (Core Period)|Participants received oral dose of placebo matching to everolimus daily.
1011221|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
1011222|NCT00789828|O2|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
1011223|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
1011224|NCT00789828|O2|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
1011225|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
1011226|NCT00789828|O3|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
1011227|NCT00789828|O2|Outcome|Placebo (Core Period)|Participants received oral dose of placebo matching to everolimus daily.
1011228|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
1011229|NCT00789828|O3|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
1011230|NCT00789828|O2|Outcome|Placebo (Core Period)|Participants received oral dose of placebo matching to everolimus daily.
1011231|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
1011232|NCT00789828|O3|Outcome|Everolimus (Extension Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.
1011233|NCT00789828|O2|Outcome|Placebo (Core Period)|Participants received oral dose of placebo matching to everolimus daily.
1011234|NCT00789828|O1|Outcome|Everolimus (Core Period)|Participants received oral dose of everolimus 4.5 mg/m^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
1011235|NCT00789828|E3|Reported Event|Placebo Treated (Core Period)|Participants who received placebo in core period.
1011236|NCT00789828|E2|Reported Event|Placebo (Core) Then Everolimus Treated (Extension Period)|Participants who received placebo in core period and then received evrolimus treatment in extension period.
1011237|NCT00789828|E1|Reported Event|Everolimus Treated (Core and Extension Period)|Participants who received everolimus treatment in core period and continued to receive evrolimus treatment in extension period.
1011238|NCT00789815|B3|Baseline|Total|Total of all reporting groups
1011239|NCT00789815|B2|Baseline|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
1011240|NCT00789815|B1|Baseline|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
1011241|NCT00789815|P2|Participant Flow|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
1011242|NCT00789815|P1|Participant Flow|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
1011243|NCT00789815|O2|Outcome|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
1011244|NCT00789815|O1|Outcome|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
1011752|NCT00788697|O1|Outcome|Offsite Reader 1 – UE-US|Offsite Reader 1 UE-US assessment
1011245|NCT00789815|O2|Outcome|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
1011246|NCT00789815|O1|Outcome|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
1011247|NCT00789815|O2|Outcome|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
1011248|NCT00789815|O1|Outcome|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
1011249|NCT00789815|O2|Outcome|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
1011250|NCT00789815|O1|Outcome|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
1011251|NCT00789815|O2|Outcome|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
1011252|NCT00789815|O1|Outcome|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
1011253|NCT00789815|O2|Outcome|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
1011254|NCT00789815|O1|Outcome|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
1011255|NCT00789815|O2|Outcome|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
1011256|NCT00789815|O1|Outcome|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
1011257|NCT00789815|O2|Outcome|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
1011258|NCT00789815|O1|Outcome|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
1011259|NCT00789815|E2|Reported Event|Clinical-judged Midazolam Administration|In the control group, induction was started using alfentanil 4~5μg/kg bolus following 2 mg midazolam bolus. After 2 minutes, if the patient was not well sedated, midazolam boluses were repeat by increments of 2 mg/min until conscious sedation was achieved
1011260|NCT00789815|E1|Reported Event|BIS-guided Propofol Infusion|In the study group, induction was started using alfentanil 4~5μg/kg bolus following repeated propofol boluses (0.5~1.5 mg/kg) until the BIS level reached 70. During maintenance, propofol infusion (3~12 mg/kg/hour) was given using a syringe pump (Injectomat Agilia, Fresenius Kabi, France), which was titrated to keep the BIS level between 65 and 75.
1011261|NCT00789802|B4|Baseline|Total|Total of all reporting groups
1011262|NCT00789802|B3|Baseline|Transdermal Estradiol|"participants will be randomized to transdermal estradiol~transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks."
1011263|NCT00789802|B2|Baseline|Oral Placebo|oral placebo : oral placebo to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks
1011264|NCT00789802|B1|Baseline|Oral Naproxen|"participants will be randomized to oral naproxen~naproxen : naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks"
1011265|NCT00789802|P3|Participant Flow|Transdermal Estradiol|"participants will be randomized to transdermal estradiol~transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks."
1011266|NCT00789802|P2|Participant Flow|Oral Placebo|oral placebo : oral placebo to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks
1011267|NCT00789802|P1|Participant Flow|Oral Naproxen|"participants will be randomized to oral naproxen~naproxen : naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks"
1011268|NCT00789802|O3|Outcome|Transdermal Estradiol|"participants will be randomized to transdermal estradiol~transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks."
1011269|NCT00789802|O2|Outcome|Oral Placebo|oral placebo : oral placebo to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks
1011270|NCT00789802|O1|Outcome|Oral Naproxen|"participants will be randomized to oral naproxen~naproxen : naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks"
1011271|NCT00789802|E3|Reported Event|Transdermal Estradiol|"participants will be randomized to transdermal estradiol~transdermal estradiol : transdermal estradiol 0.1mg patch to be changed weekly for 12 weeks."
1011272|NCT00789802|E2|Reported Event|Oral Placebo|oral placebo : oral placebo to be taken by mouth twice daily for the first 5 days of a 4 week block for a total of 5 weeks
1011273|NCT00789802|E1|Reported Event|Oral Naproxen|"participants will be randomized to oral naproxen~naproxen : naproxen 500mg by mouth twice daily for the first 5 days of every 4 week period for a total of 12 weeks"
1011274|NCT00789737|B3|Baseline|Total|Total of all reporting groups
1011275|NCT00789737|B2|Baseline|Placebo|"placebo~Placebo : placebo"
1011276|NCT00789737|B1|Baseline|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
1011277|NCT00789737|P2|Participant Flow|Placebo|"placebo~Placebo : placebo"
1011278|NCT00789737|P1|Participant Flow|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
1011279|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
1011280|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
1011281|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
1011282|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
1011283|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
1011284|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
1011285|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
1011286|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
1011287|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
1011288|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
1011289|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
1011290|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
1011291|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
1011292|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
1011293|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
1011294|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
1011295|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
1011296|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
1011297|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
1011298|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
1011299|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
1011300|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
1011301|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
1011302|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
1011303|NCT00789737|O2|Outcome|Placebo|"placebo~Placebo : placebo"
1011304|NCT00789737|O1|Outcome|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
1011305|NCT00789737|E2|Reported Event|Placebo|"placebo~Placebo : placebo"
1011306|NCT00789737|E1|Reported Event|Welchol|"Welchol 625mg tablets~Welchol : Welchol 625mg tablets"
1011307|NCT00789724|B3|Baseline|Total|Total of all reporting groups
1011308|NCT00789724|B2|Baseline|Placebo|0.67 ml of NaCl 0.9% solution
1011309|NCT00789724|B1|Baseline|Anakinra|Anakinra 100 mg given daily by subcutaneous injection for 14 days
1011310|NCT00789724|P2|Participant Flow|Placebo|0.67 ml of NaCl 0.9% solution
1011311|NCT00789724|P1|Participant Flow|Anakinra|Anakinra 100 mg given daily by subcutaneous injection for 14 days
1011312|NCT00789724|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
1011313|NCT00789724|O1|Outcome|Anakinra|Anakinra 100 mg given daily by subcutaneous injection for 14 days
1011314|NCT00789724|E2|Reported Event|Placebo|0.67 ml of NaCl 0.9% solution
1011315|NCT00789724|E1|Reported Event|Anakinra|Anakinra 100 mg given daily by subcutaneous injection for 14 days
1011316|NCT00789698|B5|Baseline|Total|Total of all reporting groups
1011317|NCT00789698|B4|Baseline|Quetiapine-Quetiapine|Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
1011318|NCT00789698|B3|Baseline|Placebo-Lurasidone|Placebo in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study
1011319|NCT00789698|B2|Baseline|Lurasidone 160 mg|Lurasidone 160mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.
1011320|NCT00789698|B1|Baseline|Lurasidone 80mg|Lurasidone 80mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.
1011321|NCT00789698|P4|Participant Flow|Quetiapine-Quetiapine|Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
1011322|NCT00789698|P3|Participant Flow|Placebo-Lurasidone|Placebo in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study
1011323|NCT00789698|P2|Participant Flow|Lurasidone 160 mg|Lurasidone 160mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.
1011324|NCT00789698|P1|Participant Flow|Lurasidone 80mg|Lurasidone 80mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.
1011325|NCT00789698|O2|Outcome|Quetiapine-Quetiapine|Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
1011326|NCT00789698|O1|Outcome|Lurasidone-Lurasidone|Lurasidone 80 mg/day or lurasidone 160 mg/day in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study.
1011327|NCT00789698|O2|Outcome|Quetiapine-Quetiapine|Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
1011328|NCT00789698|O1|Outcome|Lurasidone-Lurasidone|Lurasidone 80 mg/day or lurasidone 160 mg/day in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study.
1011329|NCT00789698|O2|Outcome|Quetiapine-Quetiapine|Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
1011330|NCT00789698|O1|Outcome|Lurasidone-Lurasidone|Lurasidone 80 mg/day or Lurasidone 160 mg/day in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study.
1011331|NCT00789698|O2|Outcome|Quetiapine-Quetiapine|Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
1011332|NCT00789698|O1|Outcome|Lurasidone-Lurasidone|Lurasidone 80 mg/day or lurasidone 160 mg/day in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study.
1011333|NCT00789698|E4|Reported Event|Quetiapine-Quetiapine|Quetiapine XR 600 mg/day in the acute phase study and flexibly-dosed quetiapine XR (200 mg/day to 800 mg/day) in the current study
1011334|NCT00789698|E3|Reported Event|Placebo-Lurasidone|Placebo in the acute phase study and flexibly-dosed lurasidone (40 mg/day to 160 mg/day) in the current study
1011335|NCT00789698|E2|Reported Event|Lurasidone 160 mg|Lurasidone 160mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.
1011336|NCT00789698|E1|Reported Event|Lurasidone 80mg|Lurasidone 80mg/day in the acute phase study and flexibly-dosed lurasidone (40mg/day to 160mg/day) in the current study.
1011337|NCT00789685|B1|Baseline|Safety Population|Safety population includes all patients who received at least one dose of study medication, and was used for summaries of demographic and other baseline characteristics
1011338|NCT00789685|P1|Participant Flow|Interferon Beta|"Interferon Beta~Interferon Beta administered intravenously daily for 6 days. Doses of 0.12 MIU, 1.2 MIU, 2.7 MIU or 6.0 MIU (dose escalation phase) or 2.7 MIU (dose expansion phase) were administered."
1011339|NCT00789685|O1|Outcome|Safety Population|Safety population includes all patients who received at least one dose of study medication
1011340|NCT00789685|O1|Outcome|Safety Population|Safety population includes all patients who received at least one dose of study medication
1011341|NCT00789685|O1|Outcome|Safety Population|Safety population includes all patients who received at least one dose of study medication
1011342|NCT00789685|E1|Reported Event|Safety Population|Safety population includes all patients who received at least one dose of study medication
1011343|NCT00789672|B3|Baseline|Total|Total of all reporting groups
1011344|NCT00789672|B2|Baseline|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
1011345|NCT00789672|B1|Baseline|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
1011346|NCT00789672|P2|Participant Flow|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
1011347|NCT00789672|P1|Participant Flow|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
1011348|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
1011349|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
1011350|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
1011351|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
1011352|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
1011353|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
1011354|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
1011355|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
1011356|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
1011357|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
1011358|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
1011359|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
1011360|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
1011361|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
1011362|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
1011363|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
1011364|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
1011365|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
1011366|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
1011367|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
1011368|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
1011369|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
1011370|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
1011371|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
1011372|NCT00789672|O2|Outcome|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
1011373|NCT00789672|O1|Outcome|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
1011374|NCT00789672|E2|Reported Event|Higher Dose 0.76 mg Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
1011375|NCT00789672|E1|Reported Event|Lower Dose 0.51 mg Levodopa/Carbidopa|Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam.
1011376|NCT00789581|B3|Baseline|Total|Total of all reporting groups
1011377|NCT00789581|B2|Baseline|Paclitaxel|"Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by paclitaxel weekly for 12 weeks.~Doxorubicin: 60 mg/m2~Cyclophosphamide: 600 mg/m2~Paclitaxel (Taxol): 80 mg/m2"
1011378|NCT00789581|B1|Baseline|Ixabepilone|"Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by ixabepilone every 3 weeks for 4 cycles.~Doxorubicin: 60 mg/m2~Cyclophosphamide: 600 mg/m2~Ixabepilone (Ixempra): 40 mg/m2"
1011379|NCT00789581|P2|Participant Flow|AC/Paclitaxel|"Doxorubicin+cyclophosphamide (AC) every 3 weeks for 4 cycles (12 weeks), followed by weekly paclitaxel for 12 weeks.~Doxorubicin: 60 mg/m2 Cyclophosphamide: 600 mg/m2 Paclitaxel (Taxol): 80 mg/m2"
1011380|NCT00789581|P1|Participant Flow|AC/Ixabepilone|"Doxorubicin+cyclophosphamide (AC) every 3 weeks for 4 cycles (12 weeks), followed by ixabepilone every 3 weeks for 4 cycles (12 weeks).~Doxorubicin: 60 mg/m2 Cyclophosphamide: 600 mg/m2 Ixabepilone (Ixempra): 40 mg/m2"
1011381|NCT00789581|O2|Outcome|Paclitaxel|"Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by paclitaxel weekly for 12 weeks.~Doxorubicin: 60 mg/m2~Cyclophosphamide: 600 mg/m2~Paclitaxel (Taxol): 80 mg/m2"
1011382|NCT00789581|O1|Outcome|Ixabepilone|"Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by ixabepilone every 3 weeks for 4 cycles.~Doxorubicin: 60 mg/m2~Cyclophosphamide: 600 mg/m2~Ixabepilone (Ixempra): 40 mg/m2"
1011383|NCT00789581|O2|Outcome|Paclitaxel|"Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by paclitaxel given weekly for 12 weeks.~Doxorubicin: 60 mg/m2~Cyclophosphamide: 600 mg/m2~Paclitaxel (Taxol): 80 mg/m2"
1011384|NCT00789581|O1|Outcome|Ixabepilone|"Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by ixabepilone every 3 weeks for 4 cycles.~Doxorubicin: 60 mg/m2~Cyclophosphamide: 600 mg/m2~Ixabepilone (Ixempra): 40 mg/m2"
1011385|NCT00789581|E2|Reported Event|Paclitaxel|"Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by paclitaxel given weekly for 12 weeks.~Doxorubicin: 60 mg/m2~Cyclophosphamide: 600 mg/m2~Paclitaxel (Taxol): 80 mg/m2"
1011386|NCT00789581|E1|Reported Event|Ixabepilone|"Doxorubicin and cyclophosphamide (AC) given every 3 weeks for 4 cycles, followed by ixabepilone every 3 weeks for 4 cycles.~Doxorubicin: 60 mg/m2~Cyclophosphamide: 600 mg/m2~Ixabepilone (Ixempra): 40 mg/m2"
1011387|NCT00789555|B4|Baseline|Total|Total of all reporting groups
1011388|NCT00789555|B3|Baseline|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
1011389|NCT00789555|B2|Baseline|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
1011390|NCT00789555|B1|Baseline|PATANASE|Two sprays in each nostril twice a day for up to 12 months
1011391|NCT00789555|P3|Participant Flow|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
1011392|NCT00789555|P2|Participant Flow|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
1011393|NCT00789555|P1|Participant Flow|PATANASE|Two sprays in each nostril twice a day for up to 12 months
1011394|NCT00789555|O3|Outcome|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
1011395|NCT00789555|O2|Outcome|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
1011396|NCT00789555|O1|Outcome|PATANASE|Two sprays in each nostril twice a day for up to 12 months
1011397|NCT00789555|O3|Outcome|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
1011398|NCT00789555|O2|Outcome|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
1011399|NCT00789555|O1|Outcome|PATANASE|Two sprays in each nostril twice a day for up to 12 months
1011400|NCT00789555|O3|Outcome|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
1011401|NCT00789555|O2|Outcome|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
1011402|NCT00789555|O1|Outcome|PATANASE|Two sprays in each nostril twice a day for up to 12 months
1011403|NCT00789555|O3|Outcome|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
1011404|NCT00789555|O2|Outcome|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
1011405|NCT00789555|O1|Outcome|PATANASE|Two sprays in each nostril twice a day for up to 12 months
1011406|NCT00789555|O3|Outcome|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
1011407|NCT00789555|O2|Outcome|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
1011408|NCT00789555|O1|Outcome|PATANASE|Two sprays in each nostril twice a day for up to 12 months
1011409|NCT00789555|O3|Outcome|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
1011410|NCT00789555|O2|Outcome|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
1011411|NCT00789555|O1|Outcome|PATANASE|Two sprays in each nostril twice a day for up to 12 months
1011412|NCT00789555|E3|Reported Event|Patanase Vehicle, pH 7.0|Two sprays in each nostril twice a day for up to 12 months
1011413|NCT00789555|E2|Reported Event|Patanase Vehicle, pH 3.7|Two sprays in each nostril twice a day for up to 12 months
1011414|NCT00789555|E1|Reported Event|PATANASE|Two sprays in each nostril twice a day for up to 12 months
1011415|NCT00789529|B3|Baseline|Total|Total of all reporting groups
1011416|NCT00789529|B2|Baseline|2 - Opti-Free RepleniSH First|Opti-Free RepleniSH first, ReNu MultiPlus Second
1011417|NCT00789529|B1|Baseline|1 - ReNu MultiPlus First|Used ReNu MultiPlus first, Opti-Free RepleniSH Second
1011418|NCT00789529|P2|Participant Flow|2 - Opti-Free RepleniSH First, ReNu MultiPlus Second|Used Opti-Free RepleniSH multi-purpose disinfecting solution for the care of new contact lenses in the first intervention period, and used ReNu MultiPlus multi-purpose solution for the care of new contact lenses in the second intervention period
1011419|NCT00789529|P1|Participant Flow|1 - ReNu MultiPlus First, Opti-Free RepleniSH Second|Used ReNu MultiPlus multi-purpose solution for the care of new contact lenses in the first intervention period, and used Opti-Free RepleniSH multi-purpose disinfecting solution for the care of new contact lenses in the second intervention period
1011420|NCT00789529|O2|Outcome|Renu MultiPlus®|Used Renu MultiPlus®
1011421|NCT00789529|O1|Outcome|Opti-Free® RepleniSH® MPDS|Used Opti-Free® RepleniSH® MPDS
1011422|NCT00789529|O2|Outcome|Renu MultiPlus®|Used Renu MultiPlus®
1011423|NCT00789529|O1|Outcome|Opti-Free® RepleniSH® MPDS|Used Opti-Free® RepleniSH® MPDS
1011424|NCT00789529|E2|Reported Event|2 - Opti-Free RepleniSH First|Opti-Free RepleniSH first, ReNu MultiPlus Second
1011425|NCT00789529|E1|Reported Event|1 - ReNu MultiPlus First|Used ReNu MultiPlus first, Opti-Free RepleniSH Second
1011426|NCT00789477|B6|Baseline|Total|Total of all reporting groups
1011427|NCT00789477|B5|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
1011428|NCT00789477|B4|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52
1011429|NCT00789477|B3|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
1011430|NCT00789477|B2|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5mg every 4 weeks to week 52
1011431|NCT00789477|B1|Baseline|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
1011432|NCT00789477|P5|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN (as-needed) dosing according to the re-treatment criteria to week 52
1011433|NCT00789477|P4|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52
1011434|NCT00789477|P3|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2 mg every 4 weeks to week 52
1011435|NCT00789477|P2|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
1011436|NCT00789477|P1|Participant Flow|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
1011437|NCT00789477|O5|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
1011438|NCT00789477|O4|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks to week 52
1011439|NCT00789477|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
1011440|NCT00789477|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
1011441|NCT00789477|O1|Outcome|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
1011525|NCT00789256|E2|Reported Event|Strata 2|will include patients who have received prior medical intervention for their disease.
1011442|NCT00789477|O5|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
1011443|NCT00789477|O4|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks to week 52
1011444|NCT00789477|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
1011445|NCT00789477|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
1011446|NCT00789477|O1|Outcome|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
1011447|NCT00789477|O5|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
1011448|NCT00789477|O4|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks to week 52
1011449|NCT00789477|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
1011450|NCT00789477|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
1011451|NCT00789477|O1|Outcome|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
1011452|NCT00789477|O5|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
1011453|NCT00789477|O4|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks to week 52
1011454|NCT00789477|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
1011455|NCT00789477|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
1011456|NCT00789477|O1|Outcome|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
1011457|NCT00789477|O5|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
1011458|NCT00789477|O4|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks to week 52
1011459|NCT00789477|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52
1011460|NCT00789477|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5mg every 4 weeks to week 52
1011461|NCT00789477|O1|Outcome|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
1011462|NCT00789477|E5|Reported Event|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
1011463|NCT00789477|E4|Reported Event|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52
1011464|NCT00789477|E3|Reported Event|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
1011465|NCT00789477|E2|Reported Event|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4|Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
1011466|NCT00789477|E1|Reported Event|Laser Photocoagulation|Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
1011467|NCT00789438|B4|Baseline|Total|Total of all reporting groups
1011468|NCT00789438|B3|Baseline|Spinal + Sedation|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia with sedation
1011469|NCT00789438|B2|Baseline|Spinal|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia
1011470|NCT00789438|B1|Baseline|General Anesthesia|Patients undergoing short-term surgery (30-90 min) under general anesthesia
1011471|NCT00789438|P3|Participant Flow|Spinal + Sedation|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia with sedation
1011472|NCT00789438|P2|Participant Flow|Spinal|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia
1011473|NCT00789438|P1|Participant Flow|General Anesthesia|Patients undergoing short-term surgery (30-90 min) under general anesthesia
1011474|NCT00789438|O3|Outcome|Spinal + Sedation|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia with sedation
1011475|NCT00789438|O2|Outcome|Spinal|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia
1011476|NCT00789438|O1|Outcome|General Anesthesia|Patients undergoing short-term surgery (30-90 min) under general anesthesia
1011477|NCT00789438|E3|Reported Event|Spinal + Sedation|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia with sedation
1011478|NCT00789438|E2|Reported Event|Spinal|Patients undergoing short-term surgery (30-90 min) under spinal anesthesia
1011479|NCT00789438|E1|Reported Event|General Anesthesia|Patients undergoing short-term surgery (30-90 min) under general anesthesia
1011481|NCT00789373|P3|Participant Flow|Pemetrexed + Cisplatin Followed by Placebo|Following Induction, received placebo (normal saline [0.9% sodium chloride]) administered IV on Day 1 of every 21-day cycle plus Best Supportive Care until PD or treatment discontinuation.
1011482|NCT00789373|P2|Participant Flow|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|Following Induction, received 500 mg/m^2 maintenance pemetrexed, IV, on Day 1 of each 21-day cycle plus Best Supportive Care until progressive disease (PD) or treatment discontinuation.
1011483|NCT00789373|P1|Participant Flow|Induction Pemetrexed + Cisplatin|"pemetrexed: 500 mg/m^2, intravenous (IV), on Day 1 of each 21-day cycle for 4 cycles.~cisplatin: 75 mg/m^2, IV, on Day 1 of each 21-day cycle for 4 cycles."
1011484|NCT00789373|O2|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
1011485|NCT00789373|O1|Outcome|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
1011486|NCT00789373|O2|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
1011487|NCT00789373|O1|Outcome|Pemetrexed Plus Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed and best supportive care
1011488|NCT00789373|O2|Outcome|Pemetrexed Plus Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
1011489|NCT00789373|O1|Outcome|Pemetrexed Plus Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
1011490|NCT00789373|O2|Outcome|Pemetrexed Plus Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
1011491|NCT00789373|O1|Outcome|Pemetrexed Plus Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
1011492|NCT00789373|O2|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
1011493|NCT00789373|O1|Outcome|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
1011494|NCT00789373|O2|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
1011495|NCT00789373|O1|Outcome|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
1011496|NCT00789373|O2|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
1011497|NCT00789373|O1|Outcome|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
1011498|NCT00789373|O2|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed and cisplatin followed by placebo plus best supportive care
1011499|NCT00789373|O1|Outcome|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
1011500|NCT00789373|O2|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
1011501|NCT00789373|O1|Outcome|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
1011502|NCT00789373|O2|Outcome|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed + cisplatin followed by placebo plus best supportive care
1011503|NCT00789373|O1|Outcome|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
1011504|NCT00789373|E3|Reported Event|Pemetrexed + Cisplatin Followed by Placebo|pemetrexed and cisplatin followed by placebo plus best supportive care
1011505|NCT00789373|E2|Reported Event|Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed|pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
1011506|NCT00789373|E1|Reported Event|Induction Pemetrexed + Cisplatin|"pemetrexed: 500 mg/m^2, intravenous (IV), on Day 1 of each 21-day cycle for 4 cycles.~cisplatin: 75 mg/m^2, IV, on Day 1 of each 21-day cycle for 4 cycles."
1011507|NCT00789321|B3|Baseline|Total|Total of all reporting groups
1011508|NCT00789321|B2|Baseline|Placebo|Participants who were randomized to treatment with placebo once daily for 6 weeks
1011509|NCT00789321|B1|Baseline|Amlodipine 10 Milligrams|Participants who were randomized to treatment with amlodipine 10 mg once daily for 6 weeks
1011510|NCT00789321|P2|Participant Flow|Placebo|Participants who were randomized to treatment with placebo once daily for 6 weeks
1011511|NCT00789321|P1|Participant Flow|Amlodipine 10 Milligrams|Participants who were randomized to treatment with amlodipine 10 mg once daily for 6 weeks
1011512|NCT00789321|O2|Outcome|Placebo|Participants who were randomized to treatment with placebo once daily for 6 weeks
1011513|NCT00789321|O1|Outcome|Amlodipine 10 Milligrams|Participants who were randomized to treatment with amlodipine 10 mg once daily for 6 weeks
1011514|NCT00789321|O2|Outcome|Placebo|Participants who were randomized to treatment with placebo once daily for 6 weeks
1011515|NCT00789321|O1|Outcome|Amlodipine 10 Milligrams|Participants who were randomized to treatment with amlodipine 10 mg once daily for 6 weeks
1011516|NCT00789321|E2|Reported Event|Placebo|Participants who were randomized to treatment with placebo once daily for 6 weeks
1011517|NCT00789321|E1|Reported Event|Amlodipine 10 Milligrams|Participants who were randomized to treatment with amlodipine 10 mg once daily for 6 weeks
1011518|NCT00789256|B3|Baseline|Total|Total of all reporting groups
1011519|NCT00789256|B2|Baseline|Strata 2|will include patients who have received prior medical intervention for their disease.
1011520|NCT00789256|B1|Baseline|Strata 1|Group 1 will include patients who have not seen prior medical intervention for their disease.
1011521|NCT00789256|P2|Participant Flow|Strata 2|will include patients who have received prior medical intervention for their disease.
1011522|NCT00789256|P1|Participant Flow|Strata 1|Group 1 will include patients who have not seen prior medical intervention for their disease.
1011523|NCT00789256|O2|Outcome|Strata 2|will include patients who have received prior medical intervention for their disease.
1011524|NCT00789256|O1|Outcome|Strata 1|Group 1 will include patients who have not seen prior medical intervention for their disease.
1011526|NCT00789256|E1|Reported Event|Strata 1|Group 1 will include patients who have not seen prior medical intervention for their disease.
1011527|NCT00789191|B3|Baseline|Total|Total of all reporting groups
1011528|NCT00789191|B2|Baseline|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
1011529|NCT00789191|B1|Baseline|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
1011530|NCT00789191|P2|Participant Flow|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
1011531|NCT00789191|P1|Participant Flow|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
1011532|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
1011533|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
1011534|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
1011535|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
1011536|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
1011537|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
1011538|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
1011539|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
1011540|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
1011541|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
1011542|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
1011543|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
1011544|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
1011545|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
1011546|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
1011547|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
1011548|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
1011549|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
1011550|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
1011551|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
1011552|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
1011553|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
1011554|NCT00789191|O2|Outcome|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
1011555|NCT00789191|O1|Outcome|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
1011556|NCT00789191|E2|Reported Event|Sita|Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
1011557|NCT00789191|E1|Reported Event|Comb|Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
1011558|NCT00789113|B1|Baseline|Extended Release Lamotrigine|Once daily dose of extended release lamotrigine given for two weeks following completion of part I of the study (regular lamotrigine)
1011559|NCT00789113|P1|Participant Flow|Extended Release Lamotrigine|"Extended Release Lamotrigine~Extended Release Lamotrigine"
1011560|NCT00789113|O2|Outcome|Extended Release Lamotrigine|Once daily dose of extended release lamotrigine given for two weeks following completion of part I of the study (regular lamotrigine)
1011561|NCT00789113|O1|Outcome|Immediate Release (IR) Lamotrigine|Study population was on chronic IR lamotrigine therapy and first period of the study was a continuation of standard treatment with IR lamotrigine.
1011562|NCT00789113|E1|Reported Event|Extended Release Lamotrigine|Once daily dose of extended release lamotrigine given for two weeks following completion of part I of the study (regular lamotrigine)
1011563|NCT00789074|B3|Baseline|Total|Total of all reporting groups
1011564|NCT00789074|B2|Baseline|Placebo|Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
1011565|NCT00789074|B1|Baseline|Varenicline Pre-treatmemt|Participants will use varenicline (1mg BD) 4-weeks prior to quitting
1011566|NCT00789074|P2|Participant Flow|Placebo|Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
1011567|NCT00789074|P1|Participant Flow|Varenicline Pre-treatmemt|Participants will use varenicline (1mg BD) 4-weeks prior to quitting
1011568|NCT00789074|O2|Outcome|Placebo|
1011569|NCT00789074|O1|Outcome|Varenicline Pre-treatment|
1011570|NCT00789074|O2|Outcome|Placebo|
1011571|NCT00789074|O1|Outcome|Varenicline Pre-treatment|
1011572|NCT00789074|O2|Outcome|Placebo|Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
1011749|NCT00788697|O4|Outcome|Offsite Reader 2 SonoVue CE-US|Offsite Reader 2 SonoVue CE-US assessment
1011573|NCT00789074|O1|Outcome|Varenicline Pre-treatmemt|Participants will use varenicline (1mg BD) 4-weeks prior to quitting
1011574|NCT00789074|O2|Outcome|Placebo|Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
1011575|NCT00789074|O1|Outcome|Varenicline Pre-treatmemt|Participants will use varenicline (1mg BD) 4-weeks prior to quitting
1011576|NCT00789074|O2|Outcome|Placebo|
1011577|NCT00789074|O1|Outcome|Varenicline|
1011578|NCT00789074|O2|Outcome|Placebo|
1011579|NCT00789074|O1|Outcome|Varenicline|
1011580|NCT00789074|E2|Reported Event|Placebo|Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting
1011581|NCT00789074|E1|Reported Event|Varenicline Pre-treatmemt|Participants will use varenicline (1mg BD) 4-weeks prior to quitting
1011582|NCT00789035|B6|Baseline|Total|Total of all reporting groups
1011583|NCT00789035|B5|Baseline|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
1011584|NCT00789035|B4|Baseline|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
1011585|NCT00789035|B3|Baseline|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
1011586|NCT00789035|B2|Baseline|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
1011587|NCT00789035|B1|Baseline|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
1011588|NCT00789035|P5|Participant Flow|Metformin OL|Patients were to take a open-label (OL) dose of 500 mg Metformin twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
1011589|NCT00789035|P4|Participant Flow|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
1011590|NCT00789035|P3|Participant Flow|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
1011591|NCT00789035|P2|Participant Flow|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
1011592|NCT00789035|P1|Participant Flow|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
1011593|NCT00789035|O3|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
1011594|NCT00789035|O2|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
1011595|NCT00789035|O1|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
1011596|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
1011597|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
1011598|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
1011599|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
1011600|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
1011601|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
1011602|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
1011603|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
1011604|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
1011605|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
1011606|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
1011607|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
1011608|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
1011609|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
1011610|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
1011611|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
1011612|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
1011613|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
1011614|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
1011615|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
1011616|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
1011617|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
1011618|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
1011619|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
1011620|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
1011621|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
1011622|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
1011623|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
1011624|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
1011625|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
1011626|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
1011627|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
1011628|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
1011629|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
1011630|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
1011631|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
1011632|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
1011633|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
1011634|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
1011635|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
1011636|NCT00789035|O5|Outcome|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
1011637|NCT00789035|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
1011638|NCT00789035|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
1011639|NCT00789035|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
1011640|NCT00789035|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
1011641|NCT00789035|E5|Reported Event|Metformin OL|Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated.
1011642|NCT00789035|E4|Reported Event|Empagliflozin 25 mg qd|Patients receive 25 mg Empagliflozin in tablets once daily.
1011643|NCT00789035|E3|Reported Event|Empagliflozin 10 mg qd|Patients receive 10 mg Empagliflozin in tablets once daily.
1011644|NCT00789035|E2|Reported Event|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
1011645|NCT00789035|E1|Reported Event|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
1011646|NCT00788957|B5|Baseline|Total|Total of all reporting groups
1011647|NCT00788957|B4|Baseline|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011648|NCT00788957|B3|Baseline|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011649|NCT00788957|B2|Baseline|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011650|NCT00788957|B1|Baseline|Part 1: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011651|NCT00788957|P6|Participant Flow|Part 3: Ganitumab|Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive ganitumab 12 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.
1011652|NCT00788957|P5|Participant Flow|Part 3: Rilotumumab|Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive rilotumumab 10 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.
1011653|NCT00788957|P4|Participant Flow|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011654|NCT00788957|P3|Participant Flow|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011655|NCT00788957|P2|Participant Flow|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011656|NCT00788957|P1|Participant Flow|Part 1: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011657|NCT00788957|O1|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011658|NCT00788957|O1|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011659|NCT00788957|O1|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011660|NCT00788957|O1|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011661|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011662|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011663|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011664|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011665|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011666|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011667|NCT00788957|O2|Outcome|Rilotumumab|Pharmacokinetics of rilotumumab in Part 1 participants who received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011668|NCT00788957|O1|Outcome|Panitumumab|Pharmacokinetics of panitumumab in Part 1 participants who received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011669|NCT00788957|O2|Outcome|Rilotumumab|Pharmacokinetics of rilotumumab in Part 1 participants who received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011670|NCT00788957|O1|Outcome|Panitumumab|Pharmacokinetics of panitumumab in Part 1 participants who received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011671|NCT00788957|O4|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011672|NCT00788957|O3|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011673|NCT00788957|O2|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011674|NCT00788957|O1|Outcome|Part 1: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011675|NCT00788957|O4|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011676|NCT00788957|O3|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011677|NCT00788957|O2|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011678|NCT00788957|O1|Outcome|Part 1: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011679|NCT00788957|O4|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011680|NCT00788957|O3|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011681|NCT00788957|O2|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011682|NCT00788957|O1|Outcome|Part 1: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011683|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011684|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011685|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011686|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011687|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011688|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011689|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011690|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011691|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011692|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011693|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011694|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011695|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011696|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011697|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011698|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011699|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011700|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011701|NCT00788957|O3|Outcome|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011702|NCT00788957|O2|Outcome|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011703|NCT00788957|O1|Outcome|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011704|NCT00788957|O1|Outcome|Part 1: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011705|NCT00788957|E4|Reported Event|Part 2: Panitumumab + Ganitumab|Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011706|NCT00788957|E3|Reported Event|Part 2: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011707|NCT00788957|E2|Reported Event|Part 2: Panitumumab Alone|Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011708|NCT00788957|E1|Reported Event|Part 1: Panitumumab + Rilotumumab|Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
1011709|NCT00788775|B3|Baseline|Total|Total of all reporting groups
1011710|NCT00788775|B2|Baseline|CNS Metastatic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
1011711|NCT00788775|B1|Baseline|No CNS Metastastic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
1011712|NCT00788775|P2|Participant Flow|CNS Metastatic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
1011750|NCT00788697|O3|Outcome|Offsite Reader 2 – UE-US|Offsite Reader 2 UE-US assessment
1011713|NCT00788775|P1|Participant Flow|No CNS Metastastic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
1011714|NCT00788775|O2|Outcome|CNS Metastatic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
1011715|NCT00788775|O1|Outcome|No CNS Metastastic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
1011716|NCT00788775|O2|Outcome|CNS Metastatic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
1011717|NCT00788775|O1|Outcome|No CNS Metastastic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
1011718|NCT00788775|O2|Outcome|CNS Metastatic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
1011719|NCT00788775|O1|Outcome|No CNS Metastastic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
1011720|NCT00788775|O2|Outcome|CNS Metastatic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
1011721|NCT00788775|O1|Outcome|No CNS Metastastic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
1011722|NCT00788775|E2|Reported Event|CNS Metastatic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
1011723|NCT00788775|E1|Reported Event|No CNS Metastastic Cohort|Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Patients were classified into two cohorts based upon presence or absence of measurable brain metastases.
1011724|NCT00788710|B4|Baseline|Total|Total of all reporting groups
1011725|NCT00788710|B3|Baseline|Placebo|Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
1011726|NCT00788710|B2|Baseline|Etoricoxib 90 mg|Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
1011727|NCT00788710|B1|Baseline|Etoricoxib 120 mg|Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
1011728|NCT00788710|P3|Participant Flow|Placebo|Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
1011729|NCT00788710|P2|Participant Flow|Etoricoxib 90 mg|Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
1011730|NCT00788710|P1|Participant Flow|Etoricoxib 120 mg|Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
1011731|NCT00788710|O3|Outcome|Placebo|Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
1011732|NCT00788710|O2|Outcome|Etoricoxib 90 mg|Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
1011733|NCT00788710|O1|Outcome|Etoricoxib 120 mg|Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
1011734|NCT00788710|O3|Outcome|Placebo|Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
1011735|NCT00788710|O2|Outcome|Etoricoxib 90 mg|Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
1011736|NCT00788710|O1|Outcome|Etoricoxib 120 mg|Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
1011737|NCT00788710|O3|Outcome|Placebo|Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
1011738|NCT00788710|O2|Outcome|Etoricoxib 90 mg|Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
1011739|NCT00788710|O1|Outcome|Etoricoxib 120 mg|Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
1011740|NCT00788710|E3|Reported Event|Placebo|Placebo - 3 tablets once daily on Days 1-5. Total treatment is 5 days.
1011741|NCT00788710|E2|Reported Event|Etoricoxib 90 mg|Etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
1011742|NCT00788710|E1|Reported Event|Etoricoxib 120 mg|Etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
1011743|NCT00788697|B1|Baseline|ITD Population|All patients who received SonoVue and enrolled in the efficacy phase, had a definite final diagnosis from truth standard and unenhanced and SonoVue-enhanced ultrasonography available
1011744|NCT00788697|P1|Participant Flow|Safety Population|All patients who received SonoVue (training and efficacy phases)
1011745|NCT00788697|O2|Outcome|CE-US|CE-US Inter-reader agreement
1011746|NCT00788697|O1|Outcome|UE-US|UE-US Inter-reader agreement
1011747|NCT00788697|O6|Outcome|Offsite Reader 3 SonoVue CE-US|Offsite Reader 3 SonoVue CE-US assessment
1011748|NCT00788697|O5|Outcome|Offsite Reader 3 UE-US|Offsite Reader 3 UE-US assessment
1011753|NCT00788697|O6|Outcome|Offsite Reader 3 SonoVue CE-US|Offsite Reader 3 SonoVue CE-US assessment
1011754|NCT00788697|O5|Outcome|Offsite Reader 3 UE-US|Offsite Reader 3 UE-US assessment
1011755|NCT00788697|O4|Outcome|Offsite Reader 2 SonoVue CE-US|Offsite Reader 2 SonoVue CE-US assessment
1011756|NCT00788697|O3|Outcome|Offsite Reader 2 – UE-US|Offsite Reader 2 UE-US assessment
1011757|NCT00788697|O2|Outcome|Offsite Reader 1 SonoVue CE-US|Offsite Reader 1 SonoVue CE-US assessment
1011758|NCT00788697|O1|Outcome|Offsite Reader 1 – UE-US|Offsite Reader 1 UE-US assessment
1011759|NCT00788697|O6|Outcome|Offsite Reader 3 SonoVue CE-US|Offsite Reader 3 SonoVue CE-US assessment
1011760|NCT00788697|O5|Outcome|Offsite Reader 3 UE-US|Offsite Reader 3 UE-US assessment
1011761|NCT00788697|O4|Outcome|Offsite Reader 2 SonoVue CE-US|Offsite Reader 2 SonoVue CE-US assessment
1011762|NCT00788697|O3|Outcome|Offsite Reader 2 – UE-US|Offsite Reader 2 UE-US assessment
1011763|NCT00788697|O2|Outcome|Offsite Reader 1 SonoVue CE-US|Offsite Reader 1 SonoVue CE-US assessment
1011764|NCT00788697|O1|Outcome|Offsite Reader 1 – UE-US|Offsite Reader 1 UE-US assessment
1011765|NCT00788697|O6|Outcome|Offsite Reader 3 SonoVue CE-US|Offsite Reader 3 SonoVue CE-US assessment
1011766|NCT00788697|O5|Outcome|Offsite Reader 3 UE-US|Offsite Reader 3 UE-US assessment
1011767|NCT00788697|O4|Outcome|Offsite Reader 2 SonoVue CE-US|Offsite Reader 2 SonoVue CE-US assessment
1011768|NCT00788697|O3|Outcome|Offsite Reader 2 – UE-US|Offsite Reader 2 UE-US assessment
1011769|NCT00788697|O2|Outcome|Offsite Reader 1 SonoVue CE-US|Offsite Reader 1 SonoVue CE-US assessment
1011770|NCT00788697|O1|Outcome|Offsite Reader 1 – UE-US|Offsite Reader 1 UE-US assessment
1011771|NCT00788697|O6|Outcome|Offsite Reader 3 SonoVue CE-US|Offsite Reader 3 SonoVue CE-US assessment
1011772|NCT00788697|O5|Outcome|Offsite Reader 3 UE-US|Offsite Reader 3 UE-US assessment
1011773|NCT00788697|O4|Outcome|Offsite Reader 2 SonoVue CE-US|Offsite Reader 2 SonoVue CE-US assessment
1011774|NCT00788697|O3|Outcome|Offsite Reader 2 – UE-US|Offsite Reader 2 UE-US assessment
1011775|NCT00788697|O2|Outcome|Offsite Reader 1 SonoVue CE-US|Offsite Reader 1 SonoVue CE-US assessment
1011776|NCT00788697|O1|Outcome|Offsite Reader 1 – UE-US|Offsite Reader 1 UE-US assessment
1011777|NCT00788697|O6|Outcome|Offsite Reader 3 SonoVue CE-US|Offsite Reader 3 SonoVue CE-US assessment
1011778|NCT00788697|O5|Outcome|Offsite Reader 3 UE-US|Offsite Reader 3 UE-US assessment
1011779|NCT00788697|O4|Outcome|Offsite Reader 2 SonoVue CE-US|Offsite Reader 2 SonoVue CE-US assessment
1011780|NCT00788697|O3|Outcome|Offsite Reader 2 – UE-US|Offsite Reader 2 UE-US assessment
1011781|NCT00788697|O2|Outcome|Offsite Reader 1 SonoVue CE-US|Offsite Reader 1 SonoVue CE-US assessment
1011782|NCT00788697|O1|Outcome|Offsite Reader 1 – UE-US|Offsite Reader 1 UE-US assessment
1011783|NCT00788697|O6|Outcome|Offsite Reader 3 SonoVue CE-US|Offsite Reader 3 SonoVue CE-US assessment
1011784|NCT00788697|O5|Outcome|Offsite Reader 3 UE-US|Offsite Reader 3 UE-US assessment
1011785|NCT00788697|O4|Outcome|Offsite Reader 2 SonoVue CE-US|Offsite Reader 2 SonoVue CE-US assessment
1011786|NCT00788697|O3|Outcome|Offsite Reader 2 – UE-US|Offsite Reader 2 UE-US assessment
1011787|NCT00788697|O2|Outcome|Offsite Reader 1 SonoVue CE-US|Offsite Reader 1 SonoVue CE-US assessment
1011788|NCT00788697|O1|Outcome|Offsite Reader 1 – UE-US|Offsite Reader 1 unenhanced (UE) US assessment
1011789|NCT00788697|E1|Reported Event|Safety Population|All patients who received SonoVue (training and efficacy phases)
1011790|NCT00788593|B1|Baseline|Entire Study Population|Includes participants who received placebo, EUR-1008 (APT-1008) high dose first and EUR-1008 (APT-1008) low dose first.
1011791|NCT00788593|P3|Participant Flow|EUR-1008 (APT-1008) Low Dose, Then High Dose|EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, as high dose in first intervention period followed by EUR-1008 (APT-1008) total high dose 140,000 lipase United States Pharmacopeia (USP) Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, as low dose in second intervention period; 7 capsules were distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment.
1011792|NCT00788593|P2|Participant Flow|EUR-1008 (APT-1008) High Dose, Then Low Dose|EUR-1008 (APT-1008) total high dose 140,000 lipase United States Pharmacopeia (USP) Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, as high dose in first intervention period followed by EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, as low dose in second intervention period; 7 capsules were distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment.
1011793|NCT00788593|P1|Participant Flow|Placebo Baseline|Placebo matched to EUR-1008 (APT-1008) capsules orally daily for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which were then randomized to either high dose or low dose of EUR-1008 (APT-1008).
1011794|NCT00788593|O2|Outcome|EUR-1008 (APT-1008) High Dose|EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
1011795|NCT00788593|O1|Outcome|EUR-1008 (APT-1008) Low Dose|EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
1011871|NCT00787930|O1|Outcome|Relapse Into Depression or Mania|Subjects who relapsed into a depressive or manic episode within the 12 months following stabilization as measured by the YMRS or MADRS scales.
1012496|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
1011796|NCT00788593|O2|Outcome|EUR-1008 (APT-1008) High Dose|EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
1011797|NCT00788593|O1|Outcome|EUR-1008 (APT-1008) Low Dose|EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
1011798|NCT00788593|O3|Outcome|EUR-1008 (APT-1008) High Dose|EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
1011799|NCT00788593|O2|Outcome|EUR-1008 (APT-1008) Low Dose|EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
1011800|NCT00788593|O1|Outcome|Placebo Baseline|Placebo matched to EUR-1008 (APT-1008) capsules, orally daily, for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which were then randomized to either high dose or low dose of EUR-1008 (APT-1008)
1011801|NCT00788593|O3|Outcome|EUR-1008 (APT-1008) High Dose|EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
1011802|NCT00788593|O2|Outcome|EUR-1008 (APT-1008) Low Dose|EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
1011803|NCT00788593|O1|Outcome|Placebo Baseline|Placebo matched to EUR-1008 (APT-1008) capsules, orally daily, for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which were then randomized to either high dose or low dose of EUR-1008 (APT-1008)
1011804|NCT00788593|O2|Outcome|EUR-1008 (APT-1008) High Dose|EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
1011805|NCT00788593|O1|Outcome|EUR-1008 (APT-1008) Low Dose|EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
1011806|NCT00788593|E3|Reported Event|EUR-1008 (APT-1008) High Dose|EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units was given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
1011807|NCT00788593|E2|Reported Event|EUR-1008 (APT-1008) Low Dose|EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units was given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
1011808|NCT00788593|E1|Reported Event|Placebo Baseline|Placebo matched to EUR-1008 (APT-1008) capsule orally daily for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which were then randomized to either high dose or low dose of EUR-1008 (APT-1008).
1011809|NCT00788372|B1|Baseline|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
1011810|NCT00788372|P1|Participant Flow|Fentanyl|Fentanyl transdermal patch (JNS020QD, patch containing a drug that is put on the skin so the drug will enter the body through the skin) was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
1011811|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
1011872|NCT00787930|O2|Outcome|Non-relapse Into Depression or Mania|Subjects who had no depressive or manic episodes within the 12 months following stabilization as measured by the YMRS or MADRS scales.
1012497|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
1011812|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
1011813|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
1011814|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
1011815|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
1011816|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
1011817|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
1011818|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
1011819|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
1011820|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
1011821|NCT00788372|O1|Outcome|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
1011822|NCT00788372|E1|Reported Event|Fentanyl|Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators’ discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
1011823|NCT00788255|B1|Baseline|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:~Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
1011824|NCT00788255|P1|Participant Flow|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:~Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
1011825|NCT00788255|O1|Outcome|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:~Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
1011873|NCT00787930|O1|Outcome|Relapse Into Depression or Mania|Subjects who relapsed into a depressive or manic episode within the 12 months following stabilization as measured by the YMRS or MADRS scales.
1011874|NCT00787930|O2|Outcome|Non-Responders to Acute Treatment|Subjects in an acute manic episode who did not respond to treatment as measured by a YMRS >15 by week 3.
1011826|NCT00788255|O1|Outcome|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:~Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
1011827|NCT00788255|O1|Outcome|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:~Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
1011828|NCT00788255|O1|Outcome|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:~Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
1011829|NCT00788255|O1|Outcome|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:~Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
1011830|NCT00788255|O1|Outcome|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:~Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
1011831|NCT00788255|O1|Outcome|All Participants|"For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows:~Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation."
1011832|NCT00788255|E4|Reported Event|0 μU/mL Exogenous Oxytocin|Thromboelastography on native blood sample.
1011833|NCT00788255|E3|Reported Event|32.9 μU/mL Exogenous Oxytocin|thromboelastography: TEG was performed on kaolin-activated citrated blood samples
1011834|NCT00788255|E2|Reported Event|30.1 μU/mL Exogenous Oxytocin|thromboelastography: TEG was performed on kaolin-activated citrated blood samples
1011835|NCT00788255|E1|Reported Event|22.5 μU/mL Exogenous Oxytocin|thromboelastography: TEG was performed on kaolin-activated citrated blood samples
1011836|NCT00788073|B3|Baseline|Total|Total of all reporting groups
1011837|NCT00788073|B2|Baseline|Placebo|placebo variable dose (same flexible dose titration protocol) bid to tid, oral, 4weeks
1011838|NCT00788073|B1|Baseline|STX209|STX209 Variable dose, 1mg bid to 10mg tid, oral capsules, 4weeks
1011839|NCT00788073|P2|Participant Flow|Placebo:STX209|"First Intervention=Placebo (Placebo variable dose (same flexible dose titration protocol) bid to tid, oral) Second Intervention=STX209 (STX209 variable dose from 1mg bid to 10mg tid, capsule, oral)~Study Design:~Placebo-controlled, Crossover study. First Intervention(28 Days)-> Withdrawal(14 Days) -> Washout(7 Days)-> Withdrawal (14 Days) Participants received all interventions."
1011840|NCT00788073|P1|Participant Flow|STX209:Placebo|"First Intervention=STX209 (STX209 variable dose from 1mg bid to 10mg tid, capsule, oral) Second Intervention=Placebo (Placebo variable dose (same flexible dose titration protocol) bid to tid, oral)~Study Design:~Placebo-controlled, Crossover study. First Intervention(28 Days)-> Withdrawal(14 Days) -> Washout(7 Days)-> Withdrawal (14 Days) Participants received all interventions."
1011841|NCT00788073|O2|Outcome|Placebo:STX209|"First Intervention=Placebo (Placebo variable dose (same flexible dose titration protocol) bid to tid, oral) Second Intervention=STX209 (STX209 variable dose from 1mg bid to 10mg tid, capsule, oral)~Study Design:~Placebo-controlled, Crossover study. First Intervention(28 Days)-> Withdrawal(14 Days) -> Washout(7 Days)-> Withdrawal (14 Days) Participants received all interventions."
1011875|NCT00787930|O1|Outcome|Responders to Acute Treatment|Subjects in an acute manic episode who responded to treatment as measured by a Young Mania Rating Scale (YMRS) <15 by week 3, which was the protocol-defined determination point for response to treatment.
1012498|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
1011842|NCT00788073|O1|Outcome|STX209:Placebo|"First Intervention=STX209 (STX209 variable dose from 1mg bid to 10mg tid, capsule, oral) Second Intervention=Placebo (Placebo variable dose (same flexible dose titration protocol) bid to tid, oral)~Study Design:~Placebo-controlled, Crossover study. First Intervention(28 Days)-> Withdrawal(14 Days) -> Washout(7 Days)-> Withdrawal (14 Days) Participants received all interventions."
1011843|NCT00788073|O2|Outcome|Placebo:STX209|"First Intervention=Placebo (Placebo variable dose (same flexible dose titration protocol) bid to tid, oral) Second Intervention=STX209 (STX209 variable dose from 1mg bid to 10mg tid, capsule, oral)~Study Design:~Placebo-controlled, Crossover study. First Intervention(28 Days)-> Withdrawal(14 Days) -> Washout(7 Days)-> Withdrawal (14 Days) Participants received all interventions."
1011844|NCT00788073|O1|Outcome|STX209:Placebo|"First Intervention=STX209 (STX209 variable dose from 1mg bid to 10mg tid, capsule, oral) Second Intervention=Placebo (Placebo variable dose (same flexible dose titration protocol) bid to tid, oral)~Study Design:~Placebo-controlled, Crossover study. First Intervention(28 Days)-> Withdrawal(14 Days) -> Washout(7 Days)-> Withdrawal (14 Days) Participants received all interventions."
1011845|NCT00788073|E2|Reported Event|Placebo|variable dose (same flexible dose titration protocol), bid to tid, capsule, Oral, 4 weeks
1011846|NCT00788073|E1|Reported Event|STX209|STX209 variable dose from 1mg bid to 10mg tid, capsule, oral, 4 weeks
1011847|NCT00788008|B3|Baseline|Total|Total of all reporting groups
1011848|NCT00788008|B2|Baseline|Propofol|Total intravenous anesthesia with propofol
1011849|NCT00788008|B1|Baseline|Isoflurane|Inhalational anesthesia with isoflurane
1011850|NCT00788008|P2|Participant Flow|Propofol|Total intravenous anesthesia with propofol
1011851|NCT00788008|P1|Participant Flow|Isoflurane|Inhalational anesthesia with isoflurane
1011852|NCT00788008|O2|Outcome|Propofol|Total intravenous anesthesia with propofol
1011853|NCT00788008|O1|Outcome|Isoflurane|Inhalational anesthesia with isoflurane
1011854|NCT00788008|E2|Reported Event|Propofol|Total intravenous anesthesia with propofol
1011855|NCT00788008|E1|Reported Event|Isoflurane|Inhalational anesthesia with isoflurane
1011856|NCT00787943|B1|Baseline|All Study Participants|Apply Formula #1 to assigned side of face twice daily. Apply Formula #2 to assigned side of face twice daily.
1011857|NCT00787943|P1|Participant Flow|All Study Participants|Apply Formula #1 to assigned side of face twice daily. Apply Formula #2 to assigned side of face twice daily.
1011858|NCT00787943|O4|Outcome|Pustules: Benzoyl Peroxide 10.0% Cream Formulation #2|Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible.
1011859|NCT00787943|O3|Outcome|Papules: Benzoyl Peroxide 10.0% Cream Formulation #2|Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible.
1011860|NCT00787943|O2|Outcome|Pustules: Benzoyl Peroxide 10.0% Cream Formulation #1|Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible.
1011861|NCT00787943|O1|Outcome|Papules: Benzoyl Peroxide 10.0% Cream Formulation #1|Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible.
1011862|NCT00787943|E2|Reported Event|Benzoyl Peroxide 10.0% Cream: Formulation #2|Formulation #2 applied to one side of the face by all 10 subjects.
1011863|NCT00787943|E1|Reported Event|Benzoyl Peroxide 10.0% Cream Formulation #1|Formulation #1 applied to one side of the face by all 10 subjects.
1011864|NCT00787930|B1|Baseline|Naturalistic Treatment|
1011865|NCT00787930|P1|Participant Flow|Naturalistic Treatment|Acutely manic subjects were treated using the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) expert consensus guidelines beginning with valproic acid (titrated to therapeutic levels) over a three week period. If there was a non-response to this intervention, then a subject would continue acute treatment using other interventions indicated by STEP-BD protocols. After stabilization, subjects were followed monthly up to a year's duration and treated using the STEP-BD expert consensus guidelines.
1011866|NCT00787930|O2|Outcome|Non-relapse Into Depression or Mania|"Subjects who relapsed into a depressive or manic episode within the 12 months following stabilization as measured by the Young Mania Rating Scale (YMRS) >15 or Montgomery Asberg Depression Rating Scale (MADRS) scales >15.~MADRS is an ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients. Scale: 0-60 Higher MADRS scores indicate more severe depression.~YMRS is an eleven-item, multiple choice diagnostic questionnaire used to measure the severity of manic episodes in patients. Scale: 0-60 Higher YMRS scores indicate more mania."
1011867|NCT00787930|O1|Outcome|Relapse Into Depression or Mania|"Subjects who relapsed into a depressive or manic episode within the 12 months following stabilization as measured by the Young Mania Rating Scale (YMRS) >15 or Montgomery Asberg Depression Rating Scale (MADRS) scales >15.~MADRS is an ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients. Scale: 0-60 Higher MADRS scores indicate more severe depression.~YMRS is an eleven-item, multiple choice diagnostic questionnaire used to measure the severity of manic episodes in patients. Scale: 0-60 Higher YMRS scores indicate more mania."
1011868|NCT00787930|O2|Outcome|Non-relapse Into Depression or Mania|"Subjects who had no depressive or manic episodes within the 12 months following stabilization as measured by the Young Mania Rating Scale (YMRS) <15 or Montgomery Asberg Depression Rating Scale (MADRS) scales <15.~MADRS is an ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients. Scale: 0-60 Higher MADRS scores indicate more severe depression.~YMRS is an eleven-item, multiple choice diagnostic questionnaire used to measure the severity of manic episodes in patients. Scale: 0-60 Higher YMRS scores indicate more mania."
1011869|NCT00787930|O1|Outcome|Relapse Into Depression or Mania|"Subjects who relapsed into a depressive or manic episode within the 12 months following stabilization as measured by the Young Mania Rating Scale (YMRS) >15 or Montgomery Asberg Depression Rating Scale (MADRS) scales >15.~MADRS is an ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients. Scale: 0-60 Higher MADRS scores indicate more severe depression.~YMRS is an eleven-item, multiple choice diagnostic questionnaire used to measure the severity of manic episodes in patients. Scale: 0-60 Higher YMRS scores indicate more mania."
1011870|NCT00787930|O2|Outcome|Non-relapse Into Depression or Mania|Subjects who had no depressive or manic episodes within the 12 months following stabilization as measured by the YMRS or MADRS scales.
1011921|NCT00787891|O2|Outcome|Rabeprazole Sodium 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
1011876|NCT00787930|E1|Reported Event|Naturalistic Treatment|Patients were treated acutely using expert consensus guidelines beginning with valproic acid. After stabilization, subjects were followed monthly up to a year's duration and treated using expert consensus guidelines. indicated.
1011877|NCT00787917|B3|Baseline|Total|Total of all reporting groups
1011878|NCT00787917|B2|Baseline|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
1011879|NCT00787917|B1|Baseline|Omalizumab|"Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.~Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase."
1011880|NCT00787917|P2|Participant Flow|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
1011881|NCT00787917|P1|Participant Flow|Omalizumab|"Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.~Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase."
1011882|NCT00787917|O2|Outcome|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
1011883|NCT00787917|O1|Outcome|Omalizumab|"Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.~Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase."
1011884|NCT00787917|O2|Outcome|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
1011885|NCT00787917|O1|Outcome|Omalizumab|"Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.~Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase."
1011886|NCT00787917|O2|Outcome|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
1011887|NCT00787917|O1|Outcome|Omalizumab|"Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.~Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase."
1011888|NCT00787917|O2|Outcome|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
1011889|NCT00787917|O1|Outcome|Omalizumab|Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.
1011922|NCT00787891|O1|Outcome|Rabeprazole Sodium 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
1012499|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
1011890|NCT00787917|O2|Outcome|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
1011891|NCT00787917|O1|Outcome|Omalizumab|"Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.~Patients completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase."
1011892|NCT00787917|O2|Outcome|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
1011893|NCT00787917|O1|Outcome|Omalizumab|Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.
1011894|NCT00787917|E3|Reported Event|Open Label Omalizumab|Patients who completed double-blinded phase of the study, enrolled into 6 months open label phase and continued in the same regimen of omalizumab as they were during double-blinded phase. A maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.
1011895|NCT00787917|E2|Reported Event|Placebo|Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
1011896|NCT00787917|E1|Reported Event|Blinded Omalizumab|Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.
1011897|NCT00787904|B3|Baseline|Total|Total of all reporting groups
1011898|NCT00787904|B2|Baseline|Surgical Control|Pre-menopausal women undergoing abdominal surgery but without ovary removal
1011899|NCT00787904|B1|Baseline|Surgical Menopause|Pre-menopausal women undergoing total hysterectomy with oophorectomy rendering them post-menopausal
1011900|NCT00787904|P2|Participant Flow|Surgical Control|Pre-menopausal women with or without surgery
1011901|NCT00787904|P1|Participant Flow|Surgical Menopause|Pre-menopausal women undergoing total hysterectomy with oophorectomy rendering them post-menopausal
1011902|NCT00787904|O2|Outcome|Surgical Control|Pre-menopausal women undergoing abdominal surgery but without ovary removal
1011903|NCT00787904|O1|Outcome|Surgical Menopause|Pre-menopausal women undergoing total hysterectomy with oophorectomy rendering them post-menopausal
1011904|NCT00787904|O2|Outcome|Surgical Control|Pre-menopausal women undergoing abdominal surgery but without ovary removal
1011905|NCT00787904|O1|Outcome|Surgical Menopause|Pre-menopausal women undergoing total hysterectomy with oophorectomy rendering them post-menopausal
1011906|NCT00787904|E2|Reported Event|Surgical Control|Pre-menopausal women undergoing abdominal surgery but without ovary removal
1011907|NCT00787904|E1|Reported Event|Surgical Menopause|Pre-menopausal women undergoing total hysterectomy with oophorectomy rendering them post-menopausal
1011908|NCT00787891|B3|Baseline|Total|Total of all reporting groups
1011909|NCT00787891|B2|Baseline|Rabeprazole 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
1011910|NCT00787891|B1|Baseline|Rabeprazole 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
1011911|NCT00787891|P2|Participant Flow|Rabeprazole 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
1011912|NCT00787891|P1|Participant Flow|Rabeprazole 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
1011913|NCT00787891|O2|Outcome|Rabeprazole Sodium 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
1011914|NCT00787891|O1|Outcome|Rabeprazole Sodium 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
1011915|NCT00787891|O2|Outcome|Rabeprazole Sodium 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
1011916|NCT00787891|O1|Outcome|Rabeprazole Sodium 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
1011917|NCT00787891|O2|Outcome|Rabeprazole Sodium 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
1011918|NCT00787891|O1|Outcome|Rabeprazole Sodium 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
1011919|NCT00787891|O2|Outcome|Rabeprazole Sodium 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
1011920|NCT00787891|O1|Outcome|Rabeprazole Sodium 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
1012237|NCT00787202|O1|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
1011923|NCT00787891|O2|Outcome|Rabeprazole Sodium 1.0 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
1011924|NCT00787891|O1|Outcome|Rabeprazole Sodium 0.5 mg/kg|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
1011925|NCT00787891|E4|Reported Event|Rabeprazole 1.0 mg/kg (Double-blind Maintenance Phase|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
1011926|NCT00787891|E3|Reported Event|Rabeprazole 0.5 mg/kg (Double-blind Maintenance Phase)|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
1011927|NCT00787891|E2|Reported Event|Rabeprazole 1.0 mg/kg (Short-term Double-blinde Phase)|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
1011928|NCT00787891|E1|Reported Event|Rabeprazole 0.5 mg/kg (Short-term Double-blinde Phase)|Pediatric micro-bead formulation of rabeprazole sodium orally administered.
1011929|NCT00787852|B3|Baseline|Total|Total of all reporting groups
1011930|NCT00787852|B2|Baseline|Group 2|"Group 2: Neoadjuvant Therapy for Potentially Resectable Stage III NSCLC STUDY SCHEMA DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-38 Paclitaxel 1 8 15 22 29 36 Surgery Carboplatin 1 8 15 22 29 36 Dasatinib ----------------------------------------------------------------- Maintenance Dasatinib RT: External radiotherapy 50.4 Gy, 1.8 Gy/fx for 28 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36,~Dasatinib Dose Level With chemoradiation Maintenance x 2 years* Dasatinib is to be taken 1x daily~50 mg daily 100 mg daily~70 mg daily 100 mg daily~100 mg daily 100 mg daily"
1011931|NCT00787852|B1|Baseline|Group 1|"DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib ----------------------------------------------------------------------Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43 Dasatinib Dose Level With chemoradiation Maintenance x 2 years* Dasatinib is to be taken 1x daily~50 mg daily 100 mg daily~70 mg daily 100 mg daily~100 mg daily 100 mg daily"
1011932|NCT00787852|P2|Participant Flow|Group 2: Dasatinib 70mg|"DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib & Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43~Dasatinib is to be taken 1x daily 70 mg daily~Maintenance x 2 years*"
1011933|NCT00787852|P1|Participant Flow|Group 1: Dasatinib 50mg|"DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib & Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43~Dasatinib is to be taken 1x daily 50 mg daily~Maintenance x 2 years*"
1011934|NCT00787852|O2|Outcome|Group 2|"Group 2: Neoadjuvant Therapy for Potentially Resectable Stage III NSCLC STUDY SCHEMA DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-38 Paclitaxel 1 8 15 22 29 36 Surgery Carboplatin 1 8 15 22 29 36 Dasatinib ----------------------------------------------------------------- Maintenance Dasatinib RT: External radiotherapy 50.4 Gy, 1.8 Gy/fx for 28 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36,~Dasatinib Dose Level With chemoradiation Maintenance x 2 years* Dasatinib is to be taken 1x daily~50 mg daily 100 mg daily~70 mg daily 100 mg daily~100 mg daily 100 mg daily"
1011935|NCT00787852|O1|Outcome|Group 1|"DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib ----------------------------------------------------------------------Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43 Dasatinib Dose Level With chemoradiation Maintenance x 2 years* Dasatinib is to be taken 1x daily~50 mg daily 100 mg daily~70 mg daily 100 mg daily~100 mg daily 100 mg daily"
1011936|NCT00787852|E2|Reported Event|Group 2|"DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib ----------------------------------------------------------------------Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43 Dasatinib Dose Level With chemoradiation Maintenance x 2 years* Dasatinib is to be taken 1x daily~70 mg daily"
1011937|NCT00787852|E1|Reported Event|Group 1|DAY Radiation 1-5 8-12 15-19 22-26 29-33 36-40 43-47 Paclitaxel 1 8 15 22 29 36 43 Carboplatin 1 8 15 22 29 36 43 Dasatinib ----------------------------------------------------------------------Maintenance Dasatinib RT: External radiotherapy, 64.8 Gy, for 35 fx Paclitaxel: 50 mg/m2/week over 1 hour IV infusion days 1, 8, 15, 22, 29, 36, 43 Carboplatin: AUC = 2 IV infusion days 1, 8, 15, 22, 29, 36, 43 Dasatinib Dose Level With chemoradiation Maintenance x 2 years* Dasatinib is to be taken 1x daily 50 mg daily
1011938|NCT00787839|B1|Baseline|Group 1|Atlanta VA Medical Center patients who meet criteria for screening for prediabetes and early diabetes based on standard guidelines of the VA, American Diabetes Association, and NIH. This primarily included outpatient Veterans. Subjects were primarily included if they had age at least 45 years and BMI of 25 or greater, but some younger subjects were also included if they had risk factors for diabetes.
1011939|NCT00787839|P1|Participant Flow|Group 1|"Atlanta VA Medical Center patients who meet criteria for screening for prediabetes and early diabetes based on standard guidelines of the VA, American Diabetes Association, and NIH. This primarily included outpatient Veterans. Subjects were primarily included if they had age at least 45 years and BMI of 25 or greater, but some younger subjects were also included if they had risk factors for diabetes.~Glucose challenge test: At a first outpatient visit, at different times of the day and without a prior fast, subjects will have a 50 gram glucose drink followed by measurement of plasma and capillary glucose along with A1c one hour later. They will also fill out questionnaires. At a second outpatient visit, in the morning after fasting overnight, they will have a 75 gram oral glucose tolerance test.~Glucose tolerance test: Subjects found to have diabetes or prediabetes on the initial glucose tolerance test may be requested to have a repeat glucose tolerance test and A1c."
1011940|NCT00787839|O8|Outcome|GCTcap - Dysglycemia - Medicare|Medicare costs per case of dysglycemia identified, using the GCTcap screening test
1011941|NCT00787839|O7|Outcome|GCTpl - Dysglycemia - Medicare|Medicare costs per case of dysglycemia identified, using the GCTpl screening test
1020876|NCT00766415|E1|Reported Event|AZD1981|AZD1981 1000 mg, twice daily
1011942|NCT00787839|O6|Outcome|GCTcap - Diabetes - Medicare|Medicare costs per case of diabetes identified, using the GCTcap screening test
1011943|NCT00787839|O5|Outcome|GCTpl - Diabetes - Medicare|Medicare costs per case of diabetes identified, using the GCTpl screening test
1011944|NCT00787839|O4|Outcome|GCTcap - Dysglycemia - VA|VA costs per case of dysglycemia identified, using the GCTcap screening test
1011945|NCT00787839|O3|Outcome|GCTpl - Dysglycemia - VA|VA costs per case of dysglycemia identified, using the GCTpl screening test
1011946|NCT00787839|O2|Outcome|GCTcap - Diabetes - VA|VA costs per case of diabetes identified, using the GCTcap screening test
1011947|NCT00787839|O1|Outcome|GCTpl - Diabetes - VA|VA costs per case of diabetes identified, using the GCTpl screening test
1011948|NCT00787839|O10|Outcome|A1c - Dysglycemia|hemoglobin A1c, measured at the time of the OGTT
1011949|NCT00787839|O9|Outcome|RCG - Dysglycemia|random capillary glucose measured prior to the 50g oral glucose challenge, performed at any time during the day, without requiring a prior overnight fast
1011950|NCT00787839|O8|Outcome|RPG - Dysglycemia|random plasma glucose measured prior to the 50g oral glucose challenge, performed at any time during the day, without requiring a prior overnight fast
1011951|NCT00787839|O7|Outcome|GCTcap - Dysglycemia|capillary glucose measured 1 hour after a 50g oral glucose challenge, performed at any time during the day, without requiring a prior overnight fast
1011952|NCT00787839|O6|Outcome|GCTpl - Dysglycemia|plasma glucose measured 1 hour after a 50g oral glucose challenge, performed at any time during the day, without requiring a prior overnight fast
1011953|NCT00787839|O5|Outcome|A1c - Diabetes|hemoglobin A1c, measured at the time of the OGTT
1011954|NCT00787839|O4|Outcome|RCG - Diabetes|random capillary glucose measured prior to administration of the 50g oral glucose challenge, at any time during the day, without requiring a prior overnight fast
1011955|NCT00787839|O3|Outcome|RPG - Diabetes|random plasma glucose measured prior to administration of the 50g oral glucose challenge, at any time during the day, without requiring a prior overnight fast
1011956|NCT00787839|O2|Outcome|GCTcap - Diabetes|capillary glucose measured 1 hour after a 50g oral glucose challenge, performed at any time during the day, without requiring a prior overnight fast
1011957|NCT00787839|O1|Outcome|GCTpl - Diabetes|plasma glucose measured 1 hour after a 50g oral glucose challenge, performed at any time during the day, without requiring a prior overnight fast
1011958|NCT00787839|E1|Reported Event|Group 1|Atlanta VA Medical Center patients who meet criteria for screening for prediabetes and early diabetes based on standard guidelines of the VA, the American Diabetes Association, and the National Institutes of Health
1011959|NCT00787800|B3|Baseline|Total|Total of all reporting groups
1011960|NCT00787800|B2|Baseline|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
1011961|NCT00787800|B1|Baseline|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
1011962|NCT00787800|P2|Participant Flow|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
1011963|NCT00787800|P1|Participant Flow|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on, along with Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
1011964|NCT00787800|O2|Outcome|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
1011965|NCT00787800|O1|Outcome|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on, along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
1011966|NCT00787800|O2|Outcome|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
1011967|NCT00787800|O1|Outcome|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
1011968|NCT00787800|O2|Outcome|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
1011969|NCT00787800|O1|Outcome|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
1011970|NCT00787800|O2|Outcome|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
1011971|NCT00787800|O1|Outcome|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on, along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
1011972|NCT00787800|O2|Outcome|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
1011973|NCT00787800|O1|Outcome|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on, along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
1011974|NCT00787800|O2|Outcome|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
1012238|NCT00787202|O5|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
1011975|NCT00787800|O1|Outcome|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
1011976|NCT00787800|E2|Reported Event|Single Chamber ICD|Single chamber Implantable Cardioverter-Defibrillator: Optimally programmed VT/VF detection and therapies will be programmed on including use of detection enhancements.
1011977|NCT00787800|E1|Reported Event|Dual Chamber ICD|Dual chamber Implantable Cardioverter-Defibrillator (ICD): Atrial therapies and minimized ventricular pacing will be programmed on along with VT/VF detection and therapies with detection enhancements; remote monitoring set to alert for sustained atrial fibrillation.
1011978|NCT00787787|B1|Baseline|Treatment (Sunitinib Malate and Capecitabine)|"Patients receive sunitinib malate PO QD on days 1-21 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence or disease progression or unacceptable toxicity.~sunitinib malate: Given PO~capecitabine: Given PO"
1011979|NCT00787787|P1|Participant Flow|Treatment (Sunitinib Malate and Capecitabine)|"Patients receive sunitinib malate PO QD on days 1-21 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence or disease progression or unacceptable toxicity.~sunitinib malate: Given PO~capecitabine: Given PO"
1011980|NCT00787787|O1|Outcome|Treatment (Sunitinib Malate and Capecitabine)|"Patients receive sunitinib malate PO QD on days 1-21 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence or disease progression or unacceptable toxicity.~sunitinib malate: Given PO~capecitabine: Given PO"
1011981|NCT00787787|O1|Outcome|Treatment (Sunitinib Malate and Capecitabine)|"Patients receive sunitinib malate PO QD on days 1-21 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence or disease progression or unacceptable toxicity.~sunitinib malate: Given PO~capecitabine: Given PO"
1011982|NCT00787787|O1|Outcome|Treatment (Sunitinib Malate and Capecitabine)|"Patients receive sunitinib malate PO QD on days 1-21 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence or disease progression or unacceptable toxicity.~sunitinib malate: Given PO~capecitabine: Given PO"
1011983|NCT00787787|E1|Reported Event|Treatment (Sunitinib Malate and Capecitabine)|"Patients receive sunitinib malate PO QD on days 1-21 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence or disease progression or unacceptable toxicity.~sunitinib malate: Given PO~capecitabine: Given PO"
1011984|NCT00787761|B1|Baseline|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
1011985|NCT00787761|P1|Participant Flow|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
1011986|NCT00787761|O1|Outcome|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
1011987|NCT00787761|O1|Outcome|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
1011988|NCT00787761|O1|Outcome|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
1011989|NCT00787761|O1|Outcome|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
1011990|NCT00787761|O1|Outcome|Severe Graft Versus Host Disease|patients receiving transplant using ATG/Bu/Flu/Cy per this protocol and who had severe graft versus host disease as a post-transplant complication
1011991|NCT00787761|O1|Outcome|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
1011992|NCT00787761|O1|Outcome|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
1011993|NCT00787761|O1|Outcome|Transplant Recipients|patients receiving transplant using ATG/Bu/Flu/Cy per this protocol
1011994|NCT00787761|E1|Reported Event|RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan|All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
1011995|NCT00787644|B3|Baseline|Total|Total of all reporting groups
1011996|NCT00787644|B2|Baseline|2. Placebo|Placebo: Matching placebo (inert tablet)
1011997|NCT00787644|B1|Baseline|1. Pioglitazone|Pioglitazone: Pioglitazone tablets; 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
1011998|NCT00787644|P2|Participant Flow|2. Placebo|Placebo: Matching placebo (inert tablet)
1011999|NCT00787644|P1|Participant Flow|1. Pioglitazone|Pioglitazone: Pioglitazone tablets; 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
1012000|NCT00787644|O2|Outcome|2. Placebo|Placebo: Matching placebo (inert tablet)
1012500|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
1012001|NCT00787644|O1|Outcome|1. Pioglitazone|Pioglitazone: Pioglitazone tablets; 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
1012002|NCT00787644|E2|Reported Event|2. Placebo|Placebo: Matching placebo (inert tablet)
1012003|NCT00787644|E1|Reported Event|1. Pioglitazone|Pioglitazone: Pioglitazone tablets; 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
1012004|NCT00787618|B4|Baseline|Total|Total of all reporting groups
1012005|NCT00787618|B3|Baseline|50 mg Proellex, Normal|"50 mg Proellex, Female subjects with normal renal function.~50 mg Proellex: Single dose"
1012006|NCT00787618|B2|Baseline|50 mg Proellex Moderate|"50 mg Proellex, Female subjects with moderate renal impairment function.~50 mg Proellex: Single dose"
1012007|NCT00787618|B1|Baseline|50 mg Proellex Mild Impairment|"50 mg Proellex single dose Female subjects with mild renal impairment function.~50 mg Proellex: Single dose"
1012008|NCT00787618|P3|Participant Flow|50 mg Proellex, Normal|"50 mg Proellex, Female subjects with normal renal function.~50 mg Proellex: Single dose"
1012009|NCT00787618|P2|Participant Flow|50 mg Proellex Moderate|"50 mg Proellex, Female subjects with moderate renal impairment function.~50 mg Proellex: Single dose"
1012010|NCT00787618|P1|Participant Flow|50 mg Proellex Mild Impairment|"50 mg Proellex single dose Female subjects with mild renal impairment function.~50 mg Proellex: Single dose"
1012011|NCT00787618|O3|Outcome|50 mg Proellex, Normal|"50 mg Proellex, Female subjects with normal renal function.~50 mg Proellex: Single dose"
1012012|NCT00787618|O2|Outcome|50 mg Proellex Moderate|"50 mg Proellex, Female subjects with moderate renal impairment function.~50 mg Proellex: Single dose"
1012013|NCT00787618|O1|Outcome|50 mg Proellex Mild Impairment|"50 mg Proellex single dose Female subjects with mild renal impairment function.~50 mg Proellex: Single dose"
1012014|NCT00787618|E3|Reported Event|50 mg Proellex, Normal|"50 mg Proellex, Female subjects with normal renal function.~50 mg Proellex: Single dose"
1012015|NCT00787618|E2|Reported Event|50 mg Proellex Moderate|"50 mg Proellex, Female subjects with moderate renal impairment function.~50 mg Proellex: Single dose"
1012016|NCT00787618|E1|Reported Event|50 mg Proellex Mild Impairment|"50 mg Proellex single dose Female subjects with mild renal impairment function.~50 mg Proellex: Single dose"
1012017|NCT00787605|B3|Baseline|Total|Total of all reporting groups
1012018|NCT00787605|B2|Baseline|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
1012019|NCT00787605|B1|Baseline|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
1012020|NCT00787605|P2|Participant Flow|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
1012021|NCT00787605|P1|Participant Flow|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
1012022|NCT00787605|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
1012023|NCT00787605|O1|Outcome|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
1012024|NCT00787605|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
1012025|NCT00787605|O1|Outcome|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
1012026|NCT00787605|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
1012027|NCT00787605|O1|Outcome|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
1012028|NCT00787605|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
1012029|NCT00787605|O1|Outcome|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
1012030|NCT00787605|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
1012031|NCT00787605|O1|Outcome|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
1012032|NCT00787605|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
1012033|NCT00787605|O1|Outcome|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
1012034|NCT00787605|E2|Reported Event|Amlodipine|Amlodipine 5 mg for 1 week followed by 10 mg for 7 weeks
1012035|NCT00787605|E1|Reported Event|Aliskiren/HCTZ|Aliskiren / HCTZ 150/12.5 mg for 1 week followed by 300/25 mg for 7 weeks
1012036|NCT00787566|B4|Baseline|Total|Total of all reporting groups
1012037|NCT00787566|B3|Baseline|2.0 mg of TRG (Intranasal Granisetron)|2.0 mg dose, intranasal powder, single spray, administered once
1012038|NCT00787566|B2|Baseline|1.0 mg of TRG (Intranasal Granisetron)|1.0 mg dose, intranasal powder, single spray, administered once
1012039|NCT00787566|B1|Baseline|0.5 mg of TRG (Intranasal Granisetron)|0.5 mg dose, intranasal powder, single spray, administered once
1012040|NCT00787566|P3|Participant Flow|2.0 mg of TRG (Intranasal Granisetron)|2.0 mg dose, intranasal powder, single spray, administered once
1012041|NCT00787566|P2|Participant Flow|1.0 mg of TRG (Intranasal Granisetron)|1.0 mg dose, intranasal powder, single spray, administered once
1012042|NCT00787566|P1|Participant Flow|0.5 mg of TRG (Intranasal Granisetron)|0.5 mg dose, intranasal powder, single spray, administered once
1012043|NCT00787566|O3|Outcome|2.0 mg of TRG (Intranasal Granisetron)|2.0 mg dose, intranasal powder, single spray, administered once
1012044|NCT00787566|O2|Outcome|1.0 mg of TRG (Intranasal Granisetron)|1.0 mg dose, intranasal powder, single spray, administered once
1012045|NCT00787566|O1|Outcome|0.5 mg of TRG (Intranasal Granisetron)|0.5 mg dose, intranasal powder, single spray, administered once
1012046|NCT00787566|E3|Reported Event|2.0 mg of TRG (Intranasal Granisetron)|2.0 mg dose, intranasal powder, single spray, administered once
1012047|NCT00787566|E2|Reported Event|1.0 mg of TRG (Intranasal Granisetron)|1.0 mg dose, intranasal powder, single spray, administered once
1012048|NCT00787566|E1|Reported Event|0.5 mg of TRG (Intranasal Granisetron)|0.5 mg dose, intranasal powder, single spray, administered once
1012049|NCT00787527|B1|Baseline|Zolinza + CHOP|"Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)~Doxorubicin : 50 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle~Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle~Zolinza (vorinostat) : Starting oral dose (Schedule A) of 300 mg once a day on Days 5-14 of 21 day cycle.~Cyclophosphamide : 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle~Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle"
1012050|NCT00787527|P1|Participant Flow|Zolinza + CHOP|"Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)~Doxorubicin: 50 mg/m^2 by vein/intravenous (IV) over 15 minutes on Day 1 of 21 day cycle~Prednisone: 100 mg tablets by mouth/orally (PO) once a day on Days 1-5 of 21 day cycle~Zolinza (vorinostat): Phase I Starting dose of 300 mg by mouth each evening on Days 5-14 of 21 day cycle.~Cyclophosphamide: 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle~Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle"
1012051|NCT00787527|O1|Outcome|Schedule B - Vorinostat Three Times Daily|"Vorinostat administered orally 300 mg three times daily from days -2 to 3 (4500 mg over 5 days per cycle) of 21 day cycle.~Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)~Doxorubicin : 50 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle~Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle~Cyclophosphamide : 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle~Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle"
1012052|NCT00787527|O2|Outcome|Schedule A - Vorinostat Twice Daily|"Vorinostat 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle) on Days 5-14 of 21 day cycle~Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)~Doxorubicin : 50 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle~Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle~Cyclophosphamide : 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle~Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle"
1012053|NCT00787527|O1|Outcome|Schedule A - Vorinostat Once Daily|"Vorinostat 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle) on Days 5-14 of 21 day cycle~Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)~Doxorubicin : 50 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle~Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle~Cyclophosphamide : 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle~Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle"
1012054|NCT00787527|O1|Outcome|Schedule A - Vorinostat Once or Twice Daily|"Vorinostat 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle) on Days 5-14 of 21 day cycle or Vorinostat 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle) on Days 5-14 of 21 day cycle~Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)~Doxorubicin : 50 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle~Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle~Cyclophosphamide : 750 mg/m^2 by vein over 1 hour on Day 1 of 21 day cycle~Vincristine : 1.4 mg/m^2 by vein over 15 minutes on Day 1 of 21 day cycle"
1012055|NCT00787527|E2|Reported Event|Schedule B: Vorinostat Three Times Daily|"Phase II: Vorinostat administered at starting dose 300 mg orally three times daily from Days -2 to 3 (4500 mg over 5 days per cycle).~Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) for 21 day cycle: Doxorubicin 50 mg/m^2 IV Day 1; Prednisone 100 mg tablets orally/day Days 1-5; Cyclophosphamide 750 mg/m^2 IV Day 1; Vincristine 1.4 mg/m^2 IV Day 1."
1012056|NCT00787527|E1|Reported Event|Schedule A: Vorinostat Once or Twice Daily|"Phase I: Vorinostat administered Days 5 to 14 at starting dose 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), next administered dose 200 mg orally twice daily (4000 mg over 10 days per cycle).~Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) for 21 day cycle: Doxorubicin 50 mg/m^2 IV Day 1; Prednisone 100 mg tablets orally/day Days 1-5; Cyclophosphamide 750 mg/m^2 IV Day 1; Vincristine 1.4 mg/m^2 IV Day 1."
1012057|NCT00787332|B3|Baseline|Total|Total of all reporting groups
1012058|NCT00787332|B2|Baseline|Argatroban®|Patients with suspected HIT randomized to IV Argatroban®
1012059|NCT00787332|B1|Baseline|Desirudin|Patients with suspected HIT randomized to SC Desirudin i
1012060|NCT00787332|P2|Participant Flow|Argatroban®|Patients with suspected HIT randomized to IV Argatroban® in a 1:1 ratio
1012061|NCT00787332|P1|Participant Flow|Desirudin|Patients with suspected HIT randomized to SC Desirudin in a 1:1 ratio
1012062|NCT00787332|O2|Outcome|Argatroban®|Patients with suspected HIT randomized to IV Argatroban® in a 1:1 ratio
1012063|NCT00787332|O1|Outcome|Desirudin|Patients with suspected HIT randomized to SC Desirudin in a 1:1 ratio
1012064|NCT00787332|E2|Reported Event|Argatroban®|Patients with suspected HIT randomized to IV Argatroban®
1012065|NCT00787332|E1|Reported Event|Desirudin|Patients with suspected HIT randomized to SC Desirudin i
1012066|NCT00787319|B1|Baseline|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
1012067|NCT00787319|P1|Participant Flow|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
1012068|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
1012069|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
1012070|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
1012071|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
1012072|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
1012073|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
1012239|NCT00787202|O4|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
1012074|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
1012075|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
1012076|NCT00787319|O1|Outcome|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
1012077|NCT00787319|E1|Reported Event|Pegaptanib|Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
1012078|NCT00787267|B1|Baseline|Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
1012079|NCT00787267|P1|Participant Flow|Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
1012080|NCT00787267|O1|Outcome|Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
1012081|NCT00787267|O1|Outcome|Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
1012082|NCT00787267|O1|Outcome|Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
1012083|NCT00787267|O1|Outcome|Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
1012084|NCT00787267|O1|Outcome|Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
1012085|NCT00787267|E1|Reported Event|Evalulable Patients That Received Dasatinib|Dasatinib: 70 mg PO twice daily until progression.
1012086|NCT00787254|B3|Baseline|Total|Total of all reporting groups
1012087|NCT00787254|B2|Baseline|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012088|NCT00787254|B1|Baseline|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012089|NCT00787254|P2|Participant Flow|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012090|NCT00787254|P1|Participant Flow|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012091|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012092|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012093|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012094|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012095|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012096|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012097|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012098|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012099|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012100|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012101|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012102|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012103|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012104|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012105|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012106|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012107|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012108|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012109|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012110|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012111|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012112|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012113|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012114|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012115|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012116|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012117|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012118|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012119|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012120|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012121|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012122|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012123|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012124|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012125|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012126|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012127|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012128|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012129|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012130|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012131|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012132|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012133|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012134|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012135|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012136|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012137|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012138|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012139|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012140|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012141|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012142|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012143|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012144|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012145|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012146|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012147|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012148|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012149|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012150|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012151|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012152|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012153|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012154|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012155|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012156|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012157|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012158|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012159|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012160|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012161|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012162|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012163|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012164|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012165|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012166|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012167|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012168|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012169|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012170|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012171|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012172|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012173|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012174|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012175|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012176|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012177|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012178|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012179|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012180|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012181|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012182|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012183|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012184|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012185|NCT00787254|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012186|NCT00787254|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012187|NCT00787254|E2|Reported Event|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
1012188|NCT00787254|E1|Reported Event|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
1012189|NCT00787241|B4|Baseline|Total|Total of all reporting groups
1012190|NCT00787241|B3|Baseline|Mild Preeclampsia Superimposed on Chronic Hypertension|Subjects with a discharge diagnosis of preeclampsia with a history of chronic hypertension prior to pregnancy
1012191|NCT00787241|B2|Baseline|Severe Preeclampsia|Subjects with a discharge diagnosis of severe preeclampsia including HELP syndrome
1012192|NCT00787241|B1|Baseline|Mild Preeclampsia|Subjects with a discharge diagnosis of mild preeclampsia
1012193|NCT00787241|P3|Participant Flow|Mild Preeclampsia Superimposed on Chronic Hypertension|Subjects with a discharge diagnosis of preeclampsia with a history of chronic hypertension prior to pregnancy
1012194|NCT00787241|P2|Participant Flow|Severe Preeclampsia|Subjects with a discharge diagnosis of severe preeclampsia including HELP syndrome
1012195|NCT00787241|P1|Participant Flow|Mild Preeclampsia|Subjects with a discharge diagnosis of mild preeclampsia
1012196|NCT00787241|O3|Outcome|Mild Preeclampsia Superimposed on Chronic Hypertension|Subjects with a diagnosis of mild preeclampsia at discharge with a history of chronic hypertension
1012197|NCT00787241|O2|Outcome|Severe Preeclampsia|Subjects with a diagnosis of severe preeclampsia at discharge
1012198|NCT00787241|O1|Outcome|Mild Preeclampsia|Subjects with a discharge diagnosis of mild preeclampsia
1012199|NCT00787241|O3|Outcome|Mild Preeclampsia Superimposed on Chronic Hypertension|Subjects with a diagnosis of mild preeclampsia at discharge with a history of chronic hypertension
1012200|NCT00787241|O2|Outcome|Severe Preeclampsia|Subjects with a diagnosis of severe preeclampsia at discharge
1012201|NCT00787241|O1|Outcome|Mild Preeclampsia|Subjects with a discharge diagnosis of mild preeclampsia
1012202|NCT00787241|O3|Outcome|Mild Preeclampsia Superimposed on Chronic Hypertension|Subjects with a diagnosis of mild preeclampsia at discharge with a history of chronic hypertension
1012203|NCT00787241|O2|Outcome|Severe Preeclampsia|Subjects with a diagnosis of severe preeclampsia at discharge
1012204|NCT00787241|O1|Outcome|Mild Preeclampsia|Subjects with a discharge diagnosis of mild preeclampsia
1012205|NCT00787241|E3|Reported Event|Mild Preeclampsia Superimposed on Chronic Hypertension|Subjects with a discharge diagnosis of preeclampsia with a history of chronic hypertension prior to pregnancy
1012206|NCT00787241|E2|Reported Event|Severe Preeclampsia|Subjects with a discharge diagnosis of severe preeclampsia including HELP syndrome
1012207|NCT00787241|E1|Reported Event|Mild Preeclampsia|Subjects with a discharge diagnosis of mild preeclampsia
1012208|NCT00787202|B6|Baseline|Total|Total of all reporting groups
1012209|NCT00787202|B5|Baseline|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
1012210|NCT00787202|B4|Baseline|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
1012211|NCT00787202|B3|Baseline|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
1012212|NCT00787202|B2|Baseline|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
1012213|NCT00787202|B1|Baseline|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
1012214|NCT00787202|P5|Participant Flow|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
1012215|NCT00787202|P4|Participant Flow|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
1012216|NCT00787202|P3|Participant Flow|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
1012217|NCT00787202|P2|Participant Flow|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 milligram (mg) orally twice daily for 8 weeks.
1012218|NCT00787202|P1|Participant Flow|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
1012219|NCT00787202|O4|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
1012220|NCT00787202|O3|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
1012221|NCT00787202|O2|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
1012222|NCT00787202|O1|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
1012223|NCT00787202|O5|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
1012224|NCT00787202|O4|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
1012225|NCT00787202|O3|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
1012226|NCT00787202|O2|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
1012227|NCT00787202|O1|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
1012228|NCT00787202|O5|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
1012229|NCT00787202|O4|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
1012230|NCT00787202|O3|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
1012231|NCT00787202|O2|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
1012232|NCT00787202|O1|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
1012233|NCT00787202|O5|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
1012234|NCT00787202|O4|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
1012235|NCT00787202|O3|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
1012236|NCT00787202|O2|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
1012501|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
1012240|NCT00787202|O3|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
1012241|NCT00787202|O2|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
1012242|NCT00787202|O1|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
1012243|NCT00787202|O5|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
1012244|NCT00787202|O4|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
1012245|NCT00787202|O3|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
1012246|NCT00787202|O2|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
1012247|NCT00787202|O1|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
1012248|NCT00787202|O5|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
1012249|NCT00787202|O4|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
1012250|NCT00787202|O3|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
1012251|NCT00787202|O2|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
1012252|NCT00787202|O1|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
1012253|NCT00787202|O5|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
1012254|NCT00787202|O4|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
1012255|NCT00787202|O3|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
1012256|NCT00787202|O2|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
1012257|NCT00787202|O1|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
1012258|NCT00787202|O5|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
1012259|NCT00787202|O4|Outcome|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
1012260|NCT00787202|O3|Outcome|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
1012261|NCT00787202|O2|Outcome|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
1012262|NCT00787202|O1|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
1012263|NCT00787202|E5|Reported Event|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 8 weeks.
1012264|NCT00787202|E4|Reported Event|CP-690,550 10 mg|CP-690,550 tablets equivalent to CP-690,550 10 mg orally twice daily for 8 weeks.
1012265|NCT00787202|E3|Reported Event|CP-690,550 3 mg|CP-690,550 tablets equivalent to CP-690,550 3 mg orally twice daily for 8 weeks.
1012266|NCT00787202|E2|Reported Event|CP-690,550 0.5 mg|CP-690,550 tablets equivalent to CP-690,550 0.5 mg orally twice daily for 8 weeks.
1012267|NCT00787202|E1|Reported Event|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 8 weeks.
1012268|NCT00787189|B3|Baseline|Total|Total of all reporting groups
1012269|NCT00787189|B2|Baseline|Control|Placebo laser device
1012270|NCT00787189|B1|Baseline|Active|Active laser device
1012271|NCT00787189|P2|Participant Flow|Control|Placebo laser device
1012272|NCT00787189|P1|Participant Flow|Active|Active laser device
1012273|NCT00787189|O2|Outcome|Control|Placebo laser device
1012274|NCT00787189|O1|Outcome|Active|Active laser device
1012275|NCT00787189|E2|Reported Event|Control|Placebo laser device
1012276|NCT00787189|E1|Reported Event|Active|Active laser device
1012277|NCT00787150|B4|Baseline|Total|Total of all reporting groups
1012278|NCT00787150|B3|Baseline|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1012279|NCT00787150|B2|Baseline|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1012280|NCT00787150|B1|Baseline|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
1012281|NCT00787150|P3|Participant Flow|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1012282|NCT00787150|P2|Participant Flow|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1012283|NCT00787150|P1|Participant Flow|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
1012284|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1012285|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1012286|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
1012287|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1012288|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1021056|NCT00765817|B3|Baseline|Total|Total of all reporting groups
1012289|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
1012290|NCT00787150|O2|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1012291|NCT00787150|O1|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1012292|NCT00787150|O2|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1012293|NCT00787150|O1|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1012294|NCT00787150|O2|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1012295|NCT00787150|O1|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1012296|NCT00787150|O2|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1012297|NCT00787150|O1|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1012298|NCT00787150|O2|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1012299|NCT00787150|O1|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1012300|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1012301|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1012302|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
1012303|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1012304|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1012305|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
1012306|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1012307|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1012308|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
1012309|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1012310|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1012311|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
1012312|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1012313|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1012314|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
1012315|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1012316|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1012317|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
1012318|NCT00787150|O3|Outcome|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1012319|NCT00787150|O2|Outcome|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1012486|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
1012487|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
1012320|NCT00787150|O1|Outcome|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
1012321|NCT00787150|E3|Reported Event|Apixaban 5.0 mg BID|One apixaban 5.0 mg tablet and 1 apixaban 2.5 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1012322|NCT00787150|E2|Reported Event|Apixaban 2.5mg BID|One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
1012323|NCT00787150|E1|Reported Event|Warfarin|The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
1012324|NCT00787137|B4|Baseline|Total|Total of all reporting groups
1012325|NCT00787137|B3|Baseline|Placebo|Control, phosphate-buffered saline
1012326|NCT00787137|B2|Baseline|PG102 1 mg/kg|Second dose PG102
1012327|NCT00787137|B1|Baseline|PG102 0.3 mg/kg|Lowest dose PG102
1012328|NCT00787137|P3|Participant Flow|Placebo|Control, phosphate-buffered saline
1012329|NCT00787137|P2|Participant Flow|PG102 1 mg/kg|Second dose PG102
1012330|NCT00787137|P1|Participant Flow|PG102 0.3 mg/kg|Lowest dose PG102
1012331|NCT00787137|O3|Outcome|Placebo|Control, phosphate-buffered saline
1012332|NCT00787137|O2|Outcome|PG102 1 mg/kg|Second dose PG102
1012333|NCT00787137|O1|Outcome|PG102 0.3 mg/kg|Lowest dose PG102
1012334|NCT00787137|O3|Outcome|Placebo|Control, phosphate-buffered saline
1012335|NCT00787137|O2|Outcome|PG102 1 mg/kg|Second dose PG102
1012336|NCT00787137|O1|Outcome|PG102 0.3 mg/kg|Lowest dose PG102
1012337|NCT00787137|O3|Outcome|Placebo|Control, phosphate-buffered saline
1012338|NCT00787137|O2|Outcome|PG102 1 mg/kg|Second dose PG102
1012339|NCT00787137|O1|Outcome|PG102 0.3 mg/kg|Lowest dose PG102
1012340|NCT00787137|O3|Outcome|Placebo|Control, phosphate-buffered saline
1012341|NCT00787137|O2|Outcome|PG102 1 mg/kg|Second dose PG102
1012342|NCT00787137|O1|Outcome|PG102 0.3 mg/kg|Lowest dose PG102
1012343|NCT00787137|O3|Outcome|Placebo|Control, phosphate-buffered saline
1012344|NCT00787137|O2|Outcome|PG102 1 mg/kg|Second dose PG102
1012345|NCT00787137|O1|Outcome|PG102 0.3 mg/kg|Lowest dose PG102
1012346|NCT00787137|E3|Reported Event|Placebo|Control, phosphate-buffered saline
1012347|NCT00787137|E2|Reported Event|PG102 1 mg/kg|Second dose PG102
1012348|NCT00787137|E1|Reported Event|PG102 0.3 mg/kg|Lowest dose PG102
1012349|NCT00787124|B3|Baseline|Total|Total of all reporting groups
1012350|NCT00787124|B2|Baseline|>=30|< 28 weeks gestation, >=30 days of age, >= 3 previous transfusions
1012351|NCT00787124|B1|Baseline|<30 Days|< 28 weeks gestation, < 30 days of age, < 3 previous transfusions
1012352|NCT00787124|P2|Participant Flow|>=30|< 28 weeks gestation, >=30 days of age, >= 3 previous transfusions
1012353|NCT00787124|P1|Participant Flow|<30 Days|< 28 weeks gestation, < 30 days of age, < 3 previous transfusions
1012354|NCT00787124|O2|Outcome|>=30|< 28 weeks gestation, >=30 days of age, >= 3 previous transfusions
1012355|NCT00787124|O1|Outcome|<30 Days|< 28 weeks gestation, < 30 days of age, < 3 previous transfusions
1012356|NCT00787124|O2|Outcome|>=30|< 28 weeks gestation, >=30 days of age, >= 3 previous transfusions
1012357|NCT00787124|O1|Outcome|<30 Days|< 28 weeks gestation, < 30 days of age, < 3 previous transfusions
1012358|NCT00787124|E2|Reported Event|>=30|< 28 weeks gestation, >=30 days of age, >= 3 previous transfusions
1012359|NCT00787124|E1|Reported Event|<30 Days|< 28 weeks gestation, < 30 days of age, < 3 previous transfusions
1012360|NCT00787020|B3|Baseline|Total|Total of all reporting groups
1012361|NCT00787020|B2|Baseline|Ventriculostomy Monitored|Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
1012362|NCT00787020|B1|Baseline|Ventriculostomy Open|Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.
1012363|NCT00787020|P2|Participant Flow|Ventriculostomy Monitored|Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
1012364|NCT00787020|P1|Participant Flow|Ventriculostomy Open|Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.
1012365|NCT00787020|O2|Outcome|Ventriculostomy Monitored|Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
1012366|NCT00787020|O1|Outcome|Ventriculostomy Open|Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.
1012367|NCT00787020|O2|Outcome|Ventriculostomy Monitored|Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
1012368|NCT00787020|O1|Outcome|Ventriculostomy Open|Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.
1012369|NCT00787020|O2|Outcome|Ventriculostomy Monitored|Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
1012488|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
1012489|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
1012370|NCT00787020|O1|Outcome|Ventriculostomy Open|Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.
1012371|NCT00787020|E2|Reported Event|Ventriculostomy Monitored|Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
1012372|NCT00787020|E1|Reported Event|Ventriculostomy Open|Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.
1012373|NCT00786994|B5|Baseline|Total|Total of all reporting groups
1012374|NCT00786994|B4|Baseline|D - Placebo Twice Daily|"Placebo (petroleum jelly) for three months twice a day (27 patients)~Placebo (petroleum jelly)"
1012375|NCT00786994|B3|Baseline|C - Placebo Once Daily|"Placebo (petroleum jelly) for three months once a day (27 patients)~Placebo (petroleum jelly)"
1012376|NCT00786994|B2|Baseline|B - Oleogel-S10 Twice Daily|"Oleogel-S10 vehicle for three months twice a day (54 patients)~Oleogel-S10: topical use once or twice daily"
1012377|NCT00786994|B1|Baseline|A - Oleogel-S10 Once Daily|"Oleogel-S10 ointment for three months once a day (54 patients)~Oleogel-S10: topical use once or twice daily"
1012378|NCT00786994|P4|Participant Flow|D - Placebo Twice Daily|"Placebo (petroleum jelly) for three months twice a day (27 patients)~Placebo (petroleum jelly)"
1012379|NCT00786994|P3|Participant Flow|C - Placebo Once Daily|"Placebo (petroleum jelly) for three months once a day (27 patients)~Placebo (petroleum jelly)"
1012380|NCT00786994|P2|Participant Flow|B - Oleogel-S10 Twice Daily|"Oleogel-S10 vehicle for three months twice a day (54 patients)~Oleogel-S10: topical use once or twice daily"
1012381|NCT00786994|P1|Participant Flow|A - Oleogel-S10 Once Daily|"Oleogel-S10 ointment for three months once a day (54 patients)~Oleogel-S10: topical use once or twice daily"
1012382|NCT00786994|O3|Outcome|C/D - Placebo Once or Twice Daily|"Placebo (petroleum jelly) for three months once or twice a day~Placebo (petroleum jelly)"
1012383|NCT00786994|O2|Outcome|B - Oleogel-S10 Twice Daily|"Oleogel-S10 vehicle for three months twice a day~Oleogel-S10: topical use once or twice daily"
1012384|NCT00786994|O1|Outcome|A - Oleogel-S10 Once Daily|"Oleogel-S10 ointment for three months once a day~Oleogel-S10: topical use once or twice daily"
1012385|NCT00786994|E4|Reported Event|D - Placebo Twice Daily|"Placebo (petroleum jelly) for three months twice a day~Placebo (petroleum jelly)"
1012386|NCT00786994|E3|Reported Event|C - Placebo Once Daily|"Placebo (petroleum jelly) for three months once a day~Placebo (petroleum jelly)"
1012387|NCT00786994|E2|Reported Event|B - Oleogel-S10 Twice Daily|"Oleogel-S10 vehicle for three months twice a day~Oleogel-S10: topical use once or twice daily"
1012388|NCT00786994|E1|Reported Event|A - Oleogel-S10 Once Daily|"Oleogel-S10 ointment for three months once a day~Oleogel-S10: topical use once or twice daily"
1012389|NCT00786916|B4|Baseline|Total|Total of all reporting groups
1012390|NCT00786916|B3|Baseline|Group C|"Lidocaine 0.5 mg/kg~lidocaine : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.5 mg/kg IV (Group C) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
1012391|NCT00786916|B2|Baseline|Group B|"Lidocaine 0.25 mg/kg~lidocaine : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.25 mg/kg IV (Group B) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
1012392|NCT00786916|B1|Baseline|Group A|"Saline~normal saline : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive saline placebo IV (Group A) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
1012393|NCT00786916|P3|Participant Flow|Group C|"Lidocaine 0.5 mg/kg~lidocaine : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.5 mg/kg IV (Group C) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
1012394|NCT00786916|P2|Participant Flow|Group B|"Lidocaine 0.25 mg/kg~lidocaine : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.25 mg/kg IV (Group B) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
1012395|NCT00786916|P1|Participant Flow|Group A|"Saline~normal saline : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive saline placebo IV (Group A) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
1012396|NCT00786916|O3|Outcome|Group C|"Lidocaine 0.5 mg/kg~lidocaine : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.5 mg/kg IV (Group C) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
1012490|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
1012491|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
1012397|NCT00786916|O2|Outcome|Group B|"Lidocaine 0.25 mg/kg~lidocaine : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.25 mg/kg IV (Group B) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
1012398|NCT00786916|O1|Outcome|Group A|"Saline~normal saline : A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive saline placebo IV (Group A) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated."
1012399|NCT00786916|E3|Reported Event|Group C|0.50 mg/kg Lidocaine Group
1012400|NCT00786916|E2|Reported Event|Group B|0.25 mg/kg Lidocaine Group
1012401|NCT00786916|E1|Reported Event|Group A|Placebo (Saline) Group
1012402|NCT00786864|B3|Baseline|Total|Total of all reporting groups
1012403|NCT00786864|B2|Baseline|Control Group|Control group - no intervention
1012404|NCT00786864|B1|Baseline|Exercise Intervention Group|Experimental Group
1012405|NCT00786864|P2|Participant Flow|Control Group|Control group - no intervention
1012406|NCT00786864|P1|Participant Flow|Exercise Intervention Group|Experimental Group
1012407|NCT00786864|O2|Outcome|Control Group|Control group - no intervention
1012408|NCT00786864|O1|Outcome|Exercise Intervention Group|Experimental Group
1012409|NCT00786864|O2|Outcome|Control Group|Control group - no intervention
1012410|NCT00786864|O1|Outcome|Exercise Intervention Group|Experimental Group
1012411|NCT00786864|O2|Outcome|Control Group|Control group - no intervention
1012412|NCT00786864|O1|Outcome|Exercise Intervention Group|Experimental Group
1012413|NCT00786864|O2|Outcome|Control Group|Control group - no intervention
1012414|NCT00786864|O1|Outcome|Exercise Intervention Group|Experimental Group
1012415|NCT00786864|E2|Reported Event|Control Group|Control group - no intervention
1012416|NCT00786864|E1|Reported Event|Exercise Intervention Group|Experimental Group
1012417|NCT00786838|B1|Baseline|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
1012418|NCT00786838|P1|Participant Flow|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
1012419|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2.
1012420|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1.
1012421|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
1012422|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1
1012423|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
1012424|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1
1012425|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
1012426|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1
1012427|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
1012428|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1
1012429|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
1012430|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1
1012431|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
1012432|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1
1012433|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
1012434|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1
1012435|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
1012436|NCT00786838|O1|Outcome|Placebo|Normal saline was administered as a 3-hour intravenous infusion on Day 1
1012437|NCT00786838|O1|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
1012438|NCT00786838|O1|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
1012439|NCT00786838|O2|Outcome|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2.
1012440|NCT00786838|O1|Outcome|Placebo|Placebo: Normal saline was administered as a 3-hour intravenous infusion on Day 1.
1012441|NCT00786838|E1|Reported Event|Trabectedin|1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2
1012442|NCT00786799|B3|Baseline|Total|Total of all reporting groups
1012443|NCT00786799|B2|Baseline|Placebo|Placebo packets had the same orange-flavored pudding with an identical appearance and taste, but included safflower oil instead of the fish oil (omega-3 fatty acids). Safflower oil was used because it is has a similar texture and is comprised of fatty acids (but not omega-3 fatty acids), and this allowed for an examination of the unique of effects of omega-3 fatty acids compared to “non-omega-3” fatty acids.
1012444|NCT00786799|B1|Baseline|Omega-3 Fatty Acids|Omega-3 fatty acids were provided as orange-flavored pudding packets (Coromega®, Vista, CA) containing 650 mg of omega-3 fatty acids, including 350 mg of eicosapentanoic acid (EPA) and 230 mg of docosahexanoic acid (DHA), given twice daily for a daily dose of 1.3 g of omega-3 fatty acids (and 1.1 g of DHA + EPA).
1012492|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
1012493|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
1012494|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
1012445|NCT00786799|P2|Participant Flow|Placebo|Placebo packets had the same orange-flavored pudding with an identical appearance and taste, but included safflower oil instead of the fish oil (omega-3 fatty acids). Safflower oil was used because it is has a similar texture and is comprised of fatty acids (but not omega-3 fatty acids), and this allowed for an examination of the unique of effects of omega-3 fatty acids compared to “non-omega-3” fatty acids.
1012446|NCT00786799|P1|Participant Flow|Omega-3 Fatty Acids|Omega-3 fatty acids were provided as orange-flavored pudding packets (Coromega®, Vista, CA) containing 650 mg of omega-3 fatty acids, including 350 mg of eicosapentanoic acid (EPA) and 230 mg of docosahexanoic acid (DHA), given twice daily for a daily dose of 1.3 g of omega-3 fatty acids (and 1.1 g of DHA + EPA).
1012447|NCT00786799|O2|Outcome|Placebo Group: Change in TNFα|
1012448|NCT00786799|O1|Outcome|Active Omega-3 Group: Change in TNFα|
1012449|NCT00786799|O2|Outcome|Placebo Group: Change in Levels of Omega 3 Fatty Acids|Change in percentage of serum levels of Omega-3 fatty acids in the placebo group (100% * ((One Year - Baseline)/Baseline).
1012450|NCT00786799|O1|Outcome|Active Omega-3 Group: Change in Levels of Omega 3 Fatty Acids|Change in percentage of serum levels of Omega-3 fatty acids in the active Omega-3 group (100% * ((One Year - Baseline)/Baseline)
1012451|NCT00786799|O3|Outcome|Comparison Between Omega-3 and Placebo Groups|Comparison of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score between Omega-3 and Placebo groups (p-value given in statistical analysis section)
1012452|NCT00786799|O2|Outcome|Placebo|Mean and Standard Deviation of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score within Placebo Group Only
1012453|NCT00786799|O1|Outcome|Active Omega-3|Mean and Standard Deviation of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score within Omega-3 Group Only
1012454|NCT00786799|E2|Reported Event|Placebo|Placebo packets had the same orange-flavored pudding with an identical appearance and taste, but included safflower oil instead of the fish oil (omega-3 fatty acids). Safflower oil was used because it is has a similar texture and is comprised of fatty acids (but not omega-3 fatty acids), and this allowed for an examination of the unique of effects of omega-3 fatty acids compared to “non-omega-3” fatty acids.
1012455|NCT00786799|E1|Reported Event|Omega-3 Fatty Acids|Omega-3 fatty acids were provided as orange-flavored pudding packets (Coromega®, Vista, CA) containing 650 mg of omega-3 fatty acids, including 350 mg of eicosapentanoic acid (EPA) and 230 mg of docosahexanoic acid (DHA), given twice daily for a daily dose of 1.3 g of omega-3 fatty acids (and 1.1 g of DHA + EPA).
1012456|NCT00786682|B1|Baseline|Docetaxel and Hydroxychloroquine|"Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle~Drug: hydroxychloroquine 200 mg twice daily~A cycle is defined as an interval of 21 days."
1012457|NCT00786682|P1|Participant Flow|Docetaxel and Hydroxychloroquine|"Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle~Drug: hydroxychloroquine 200 mg twice daily~A cycle is defined as an interval of 21 days."
1012458|NCT00786682|O1|Outcome|Docetaxel and Hydroxychloroquine|"Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle~Drug: hydroxychloroquine 200 mg twice daily~A cycle is defined as an interval of 21 days."
1012459|NCT00786682|O1|Outcome|Docetaxel and Hydroxychloroquine|"Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle~Drug: hydroxychloroquine 200 mg twice daily~A cycle is defined as an interval of 21 days."
1012460|NCT00786682|O1|Outcome|Docetaxel and Hydroxychloroquine|"Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle~Drug: hydroxychloroquine 200 mg twice daily~A cycle is defined as an interval of 21 days."
1012461|NCT00786682|E1|Reported Event|Docetaxel and Hydroxychloroquine|"Drug: Docetaxel 75 mg/m2 intravenously every 21 days on Day 1 of the treatment cycle~Drug: hydroxychloroquine 200 mg twice daily~A cycle is defined as an interval of 21 days."
1012462|NCT00786643|B3|Baseline|Total|Total of all reporting groups
1012463|NCT00786643|B2|Baseline|Stratum 2|Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
1012464|NCT00786643|B1|Baseline|Stratum 1|Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
1012465|NCT00786643|P2|Participant Flow|Stratum 2|Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
1012466|NCT00786643|P1|Participant Flow|Stratum 1|Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
1012467|NCT00786643|O2|Outcome|Stratum 2|Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
1012468|NCT00786643|O1|Outcome|Stratum 1|Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
1012469|NCT00786643|O2|Outcome|Stratum 2|Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
1012470|NCT00786643|O1|Outcome|Stratum 1|Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
1012471|NCT00786643|O2|Outcome|Stratum 2|Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
1012472|NCT00786643|O1|Outcome|Stratum 1|Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
1012473|NCT00786643|E2|Reported Event|Stratum 2|Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.
1012474|NCT00786643|E1|Reported Event|Stratum 1|Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
1012475|NCT00786565|B1|Baseline|Akreos Intraocular Lens|
1012476|NCT00786565|P1|Participant Flow|Akreos Intraocular Lens|Subjects randomised to receive Akreos Advanced Optic Aspheric Intraocular Lens in one eye and Akreos Adapt Spherical Intraocular Lens in the fellow eye.
1012477|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
1012478|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
1012479|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
1012480|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
1012481|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
1012482|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
1012483|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
1012484|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
1012485|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
1012502|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
1012503|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
1012504|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
1012505|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
1012506|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
1012507|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
1012508|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
1012509|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
1012510|NCT00786565|O1|Outcome|Akreos Advanced Optics|Akreos Advanced Optics Intraocular Lens
1012511|NCT00786565|E2|Reported Event|Akreos Adapt Intraocular Lens|Akreos Advanced Optic Aspheric Intraocular Lens in one eye and Akreos Adapt Spherical Intraocular Lens in the fellow eye.
1012512|NCT00786565|E1|Reported Event|Akreos Advanced Intraocular Lenses|Akreos Advanced Optic Aspheric Intraocular Lens in one eye and Akreos Adapt Spherical Intraocular Lens in the fellow eye.
1012513|NCT00786487|B5|Baseline|Total|Total of all reporting groups
1012514|NCT00786487|B4|Baseline|Glycerol Untrained|"glycerol infusion into untrained subjects~glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
1012515|NCT00786487|B3|Baseline|Lipid Untrained|"lipid infusion into untrained subjects~20% lipid infusion: 1.5 ml/min for 6 hours"
1012516|NCT00786487|B2|Baseline|Glycerol Trained|"glycerol infusion into trained subjects~glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
1012517|NCT00786487|B1|Baseline|Lipid Trained|"20% lipid infusion in trained subjects~20% lipid infusion: 1.5 ml/min for 6 hours"
1012518|NCT00786487|P4|Participant Flow|Glycerol Untrained|"glycerol infusion into untrained subjects~glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
1012519|NCT00786487|P3|Participant Flow|Lipid Untrained|"lipid infusion into untrained subjects~20% lipid infusion: 1.5 ml/min for 6 hours"
1012520|NCT00786487|P2|Participant Flow|Glycerol Trained|"glycerol infusion into trained subjects~glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
1012521|NCT00786487|P1|Participant Flow|Lipid Trained|"20% lipid infusion in trained subjects~20% lipid infusion: 1.5 ml/min for 6 hours"
1012522|NCT00786487|O4|Outcome|Glycerol Untrained|"glycerol infusion into untrained subjects~glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
1012523|NCT00786487|O3|Outcome|Lipid Untrained|"lipid infusion into untrained subjects~20% lipid infusion: 1.5 ml/min for 6 hours"
1012524|NCT00786487|O2|Outcome|Glycerol Trained|"glycerol infusion into trained subjects~glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
1012525|NCT00786487|O1|Outcome|Lipid Trained|"20% lipid infusion in trained subjects~20% lipid infusion: 1.5 ml/min for 6 hours"
1012526|NCT00786487|E4|Reported Event|Glycerol Untrained|"glycerol infusion into untrained subjects~glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
1012527|NCT00786487|E3|Reported Event|Lipid Untrained|"lipid infusion into untrained subjects~20% lipid infusion: 1.5 ml/min for 6 hours"
1012528|NCT00786487|E2|Reported Event|Glycerol Trained|"glycerol infusion into trained subjects~glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,"
1012529|NCT00786487|E1|Reported Event|Lipid Trained|"20% lipid infusion in trained subjects~20% lipid infusion: 1.5 ml/min for 6 hours"
1012530|NCT00786474|B3|Baseline|Total|Total of all reporting groups
1012531|NCT00786474|B2|Baseline|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
1012532|NCT00786474|B1|Baseline|Placebo|Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
1012533|NCT00786474|P2|Participant Flow|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
1012534|NCT00786474|P1|Participant Flow|Placebo|Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
1012535|NCT00786474|O2|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
1012536|NCT00786474|O1|Outcome|Placebo|Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
1012537|NCT00786474|O2|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
1012538|NCT00786474|O1|Outcome|Placebo|Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
1012539|NCT00786474|O2|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
1012540|NCT00786474|O1|Outcome|Placebo|Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
1012541|NCT00786474|O2|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
1012542|NCT00786474|O1|Outcome|Placebo|Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
1012543|NCT00786474|E2|Reported Event|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
1012544|NCT00786474|E1|Reported Event|Placebo|Placebo: Normal saline solution, dosage determined by weight, self-administered by patient twice a day
1012545|NCT00786422|B1|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
1012546|NCT00786422|P1|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
1012547|NCT00786422|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
1012548|NCT00786422|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
1012549|NCT00786422|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
1012550|NCT00786422|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
1012551|NCT00786422|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
1012552|NCT00786422|O2|Outcome|Rivaroxaban Extended Treatment|Participants received 20 mg rivaroxaban bid (twice-daily) orally for the remainder of the 3-month treatment period.
1012553|NCT00786422|O1|Outcome|Rivaroxaban Initial Treatment|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks.
1012554|NCT00786422|O2|Outcome|Rivaroxaban Extended Treatment|Participants received 20 mg rivaroxaban bid (twice-daily) orally for the remainder of the 3-month treatment period.
1012555|NCT00786422|O1|Outcome|Rivaroxaban Initial Treatment|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks.
1012556|NCT00786422|O2|Outcome|Rivaroxaban Extended Treatment|Participants received 20 mg rivaroxaban bid (twice-daily) orally for the remainder of the 3-month treatment period.
1012557|NCT00786422|O1|Outcome|Rivaroxaban Initial Treatment|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks.
1012558|NCT00786422|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
1012559|NCT00786422|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
1012560|NCT00786422|E1|Reported Event|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.
1012561|NCT00786188|B3|Baseline|Total|Total of all reporting groups
1012562|NCT00786188|B2|Baseline|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill.
1012563|NCT00786188|B1|Baseline|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.
1012564|NCT00786188|P2|Participant Flow|Placebo - Sugar Pill|"Interventions Administered:~Subjects received placebo capsules administered once daily at bedtime.~Eligible subjects were entered into a 1-week observation period followed by a 1-week run-in period. After completion of run-in period, eligible subjects were randomized to receive placebo administered once daily at bedtime."
1012565|NCT00786188|P1|Participant Flow|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Interventions Administered:~Subjects received Brisdelle (paroxetine mesylate) Capsules 7.5 mg administered once daily at bedtime.~Eligible subjects were entered into a 1-week observation period followed by a 1-week run-in period. After completion of run-in period, eligible subjects were randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg administered once daily at bedtime."
1012566|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
1012567|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.~Subjects will be randomized to one of the two treatments in a 1:1 ratio."
1012568|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
1012569|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.~Subjects will be randomized to one of the two treatments in a 1:1 ratio."
1012570|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
1012571|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.~Subjects will be randomized to one of the two treatments in a 1:1 ratio."
1012572|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
1012573|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.~Subjects will be randomized to one of the two treatments in a 1:1 ratio."
1012574|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
1012575|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.~Subjects will be randomized to one of the two treatments in a 1:1 ratio."
1012576|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
1012577|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.~Subjects will be randomized to one of the two treatments in a 1:1 ratio."
1012578|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
1012579|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.~Subjects will be randomized to one of the two treatments in a 1:1 ratio."
1012580|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
1012581|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.~Subjects will be randomized to one of the two treatments in a 1:1 ratio."
1012582|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
1012583|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.~Subjects will be randomized to one of the two treatments in a 1:1 ratio."
1012584|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
1012585|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
1012586|NCT00786188|O2|Outcome|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio.
1012587|NCT00786188|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg capsules.~Subjects will be randomized to one of the two treatments in a 1:1 ratio"
1012588|NCT00786188|E2|Reported Event|Placebo - Sugar Pill|Eligible subjects will be randomized to receive a sugar pill.
1012589|NCT00786188|E1|Reported Event|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.
1012590|NCT00786032|B1|Baseline|BCI Device|"All participants will use the BCI System as a means of communication.~Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
1012591|NCT00786032|P1|Participant Flow|BCI Device|"All participants will use the BCI System as a means of communication.~Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
1012592|NCT00786032|O1|Outcome|BCI Device|"All participants will use the BCI System as a means of communication.~Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
1012593|NCT00786032|O1|Outcome|BCI Device|"All participants will use the BCI System as a means of communication.~Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
1012594|NCT00786032|O1|Outcome|BCI Device|"All participants will use the BCI System as a means of communication.~Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
1012595|NCT00786032|O1|Outcome|BCI Device|"All participants will use the BCI System as a means of communication.~Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
1012596|NCT00786032|O1|Outcome|BCI Device - Time Assisting Patient With Device|"All participants will use the BCI System as a means of communication.~Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles. The time was measured of how long the the caregiver assisted the patient with the device."
1012597|NCT00786032|O1|Outcome|BCI Device|"The McGill Quality of Life (MQOL) is a 16 item scale that has five distinct sub-measures: physical well-being; physical symptoms; psychological symptoms; existential well-being; support. These sub-measures are averaged to give a MQOL total score.~The range of total score is from 0 (worst) to 10 (best)."
1012598|NCT00786032|O1|Outcome|BCI Device|"All participants will use the BCI System as a means of communication.~Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
1012599|NCT00786032|E1|Reported Event|BCI Device|"All participants will use the BCI System as a means of communication.~Brain Computer Interface (BCI): A Brain Computer interface or BCI records brain signals and analyzes them to derive device commands. BCIs give their users communication and control channels that do not depend on peripheral nerves and muscles."
1012600|NCT00785980|B1|Baseline|Quinine Alone, Ciprofloxacin Alone, Quinine With Ciprofloxacin|All subjects received a single dose of quinine sulfate (2 x 324 mg capsules) on Day 1 following an overnight fast of at least 10 hours. After a 7-day washout period, beginning on the morning of Day 8 subjects received a dose of ciprofloxacin (1 x 500 mg tablet) twice a day for 4 days. On Day 11 in the morning, subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg tablet). On Day 11 in the evening, the final dose of ciprofloxacin (1 x 500 mg tablet) was administered.
1012601|NCT00785980|P1|Participant Flow|Quinine Alone, Ciprofloxacin Alone, Quinine With Ciprofloxacin|All subjects received a single dose of quinine sulfate (2 x 324 mg capsules) on Day 1 following an overnight fast of at least 10 hours. After a 7-day washout period, beginning on the morning of Day 8 subjects received a dose of ciprofloxacin (1 x 500 mg tablet) twice a day for 4 days. On Day 11 in the morning, subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg tablet). On Day 11 in the evening, the final dose of ciprofloxacin (1 x 500 mg tablet) was administered.
1012602|NCT00785980|O2|Outcome|Quinine Sulfate With Ciprofloxacin|On Day 11 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg).
1012603|NCT00785980|O1|Outcome|Quinine Sulfate Alone|On Day 1 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) followed by a 7-day washout period.
1012604|NCT00785980|O2|Outcome|Quinine Sulfate With Ciprofloxacin|On Day 11 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg).
1012605|NCT00785980|O1|Outcome|Quinine Sulfate Alone|On Day 1 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) followed by a 7-day washout period.
1012606|NCT00785980|O2|Outcome|Quinine Sulfate With Ciprofloxacin|On Day 11 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg).
1012607|NCT00785980|O1|Outcome|Quinine Sulfate Alone|On Day 1 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) followed by a 7-day washout period.
1012608|NCT00785980|E3|Reported Event|Quinine Sulfate With Ciprofloxacin|On Day 11 in the morning, all subjects received a dose of quinine sulfate (2 x 324 mg capsules) co-administered with a dose of ciprofloxacin (1 x 500 mg tablet) after an overnight fast of at least 10 hours.
1012609|NCT00785980|E2|Reported Event|Ciprofloxacin Alone|Beginning on Day 8 in the morning and continuing through Day 11 in the evening, all subjects received a dose of ciprofloxacin (1 x 500 mg tablet) twice daily for a total of 8 doses.
1012610|NCT00785980|E1|Reported Event|Quinine Sulfate Alone|On Day 1 in the morning, after a fast of at least 10 hours, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) followed by a 7-day washout period. On Day 11 in the morning, all subjects received a single dose of quinine sulfate (2 x 324 mg capsules) co-administered with a single dose of ciprofloxacin (1 x 500 mg tablet) following an overnight fast of 10 hours.
1012611|NCT00785798|B1|Baseline|Vorinostat and Pegylated Liposomal Doxorubicin Intervention|"Escalating doses of vorinostat 200mg to 400mg twice daily on days 1-7, and fixed-dose IV PLD 30mg/m2 on day 3 of a 21-day cycle~Pegylated Liposomal Doxorubicin (PLD) : IV 30mg/m2 on day 3 of a 21-day cycle~Vorinostat : 200mg to 400 mg twice daily on days 1-7"
1012612|NCT00785798|P1|Participant Flow|Vorinostat and Pegylated Liposomal Doxorubicin Intervention|"Escalating doses of vorinostat 200mg to 400mg twice daily on days 1-7, and fixed-dose IV PLD 30mg/m2 on day 3 of a 21-day cycle~Pegylated Liposomal Doxorubicin (PLD) : IV 30mg/m2 on day 3 of a 21-day cycle~Vorinostat : 200mg to 400 mg twice daily on days 1-7"
1012613|NCT00785798|O1|Outcome|Vorinostat and Pegylated Liposomal Doxorubicin Intervention|"Escalating doses of vorinostat 200mg to 400mg twice daily on days 1-7, and fixed-dose IV PLD 30mg/m2 on day 3 of a 21-day cycle~Pegylated Liposomal Doxorubicin (PLD) : IV 30mg/m2 on day 3 of a 21-day cycle~Vorinostat : 200mg to 400 mg twice daily on days 1-7"
1012614|NCT00785798|O1|Outcome|Vorinostat and Pegylated Liposomal Doxorubicin Intervention|"Escalating doses of vorinostat 200mg to 400mg twice daily on days 1-7, and fixed-dose IV PLD 30mg/m2 on day 3 of a 21-day cycle~Pegylated Liposomal Doxorubicin (PLD) : IV 30mg/m2 on day 3 of a 21-day cycle~Vorinostat : 200mg to 400 mg twice daily on days 1-7"
1012615|NCT00785798|E1|Reported Event|Vorinostat Doxil|"Escalating doses of vorinostat 200mg to 400mg twice daily on days 1-7, and fixed-dose IV PLD 30mg/m2 on day 3 of a 21-day cycle~Vorinostat: 200mg to 400 mg twice daily on days 1-7~Pegylated Liposomal Doxorubicin (PLD), Doxil: IV 30mg/m2 on day 3 of a 21-day cycle"
1012616|NCT00785785|B3|Baseline|Total|Total of all reporting groups
1012617|NCT00785785|B2|Baseline|Nilotinib First, Then Imatinib|patients were on nilotinib 400 mg twice a day in the core phase and then crossed over to in the extension phase imatinib 400mg once daily
1012618|NCT00785785|B1|Baseline|Imatinib First, Then Nilotinib|patients were on imatinib 400mg once daily in the core phase and then crossed over to nilotinib 400 mg twice a day in the extension phase
1012619|NCT00785785|P2|Participant Flow|Nilotinib First, Then Imatinib|patients were on nilotinib 400 mg twice a day in the core phase and then crossed over to in the extension phase imatinib 400mg once daily
1012620|NCT00785785|P1|Participant Flow|Imatinib First, Then Nilotinib|patients were on imatinib 400mg once daily in the core phase and then crossed over to nilotinib 400 mg twice a day in the extension phase
1012621|NCT00785785|O2|Outcome|Imatinib|imatinib 400 mg once daily
1012622|NCT00785785|O1|Outcome|Nilotinib|nilotinib 400 mg twice a day
1012623|NCT00785785|E4|Reported Event|Crossover Imatinib|exposure to nilotinib and then imatinib
1012624|NCT00785785|E3|Reported Event|Crossover Nilotinib|exposure to imatinib and then nilotinib
1012625|NCT00785785|E2|Reported Event|Imatinib|Exposure to Imatinib only
1012626|NCT00785785|E1|Reported Event|Nilotinib|Exposure to Nilotinib only
1012627|NCT00785772|B1|Baseline|Gabapentin|"The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.~The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days."
1012628|NCT00785772|P1|Participant Flow|Gabapentin|"The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.~The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days."
1012629|NCT00785772|O1|Outcome|Gabapentin|"The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.~The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days."
1012630|NCT00785772|O1|Outcome|Gabapentin|"The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.~The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days."
1012631|NCT00785772|O1|Outcome|Gabapentin|"The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.~The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days."
1012677|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
1012678|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
1012632|NCT00785772|E1|Reported Event|Gabapentin|"The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.~The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days."
1012633|NCT00785629|B5|Baseline|Total|Total of all reporting groups
1012634|NCT00785629|B4|Baseline|Placebo|
1012635|NCT00785629|B3|Baseline|Lanthanum Carbonate|phosphate binder : starting dose 500mg; titrations to 1500mg QAC
1012636|NCT00785629|B2|Baseline|Sevelamer Carbonate|phosphate binder : starting dose 800mg; titrations to 3200mg QAC
1012637|NCT00785629|B1|Baseline|Calcium Acetate|phosphate binder : starting dose 667mg;titrations to 2668mg QAC
1012638|NCT00785629|P4|Participant Flow|Placebo|
1012639|NCT00785629|P3|Participant Flow|Lanthanum Carbonate|phosphate binder : starting dose 500mg; titrations to 1500mg QAC
1012640|NCT00785629|P2|Participant Flow|Sevelamer Carbonate|phosphate binder : starting dose 800mg; titrations to 3200mg QAC
1012641|NCT00785629|P1|Participant Flow|Calcium Acetate|phosphate binder : starting dose 667mg;titrations to 2668mg QAC
1012642|NCT00785629|O2|Outcome|All Placebo Treated Patients|All placebo treated patients
1012643|NCT00785629|O1|Outcome|All Active Treated Patients|All actively treated patients
1012644|NCT00785629|E4|Reported Event|Calcium Acetate|
1012645|NCT00785629|E3|Reported Event|Sevelamer Carbonate|
1012646|NCT00785629|E2|Reported Event|Lanthanum Carbonate|
1012647|NCT00785629|E1|Reported Event|Placebo|
1012648|NCT00785577|B6|Baseline|Total|Total of all reporting groups
1012649|NCT00785577|B5|Baseline|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
1012650|NCT00785577|B4|Baseline|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
1012651|NCT00785577|B3|Baseline|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
1012652|NCT00785577|B2|Baseline|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
1012653|NCT00785577|B1|Baseline|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
1012654|NCT00785577|P5|Participant Flow|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
1012655|NCT00785577|P4|Participant Flow|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
1012656|NCT00785577|P3|Participant Flow|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
1012657|NCT00785577|P2|Participant Flow|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
1012658|NCT00785577|P1|Participant Flow|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
1012659|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
1012660|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
1012661|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
1012662|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
1012663|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
1012664|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
1012665|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
1012666|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
1012667|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
1012668|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
1012669|NCT00785577|O2|Outcome|Compound 645838 (CLm)|Plasma Compound 645838 concentrations were obtained following daily oral doses of LY545694 21 mg to 105 mg.
1012670|NCT00785577|O1|Outcome|LY545694 Clearance (CLp)|Plasma LY545694 concentrations were obtained following daily oral doses of LY545694 21 mg to LY545694 105 mg.
1012671|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
1012672|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
1012673|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
1012674|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
1012675|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
1012676|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
1012800|NCT00785512|O2|Outcome|Placebo|Matching placebo tablets, oral administration
1012679|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
1012680|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
1012681|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
1012682|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
1012683|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
1012684|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
1012685|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
1012686|NCT00785577|O4|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
1012687|NCT00785577|O3|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
1012688|NCT00785577|O2|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
1012689|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
1012690|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
1012691|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
1012692|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
1012693|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
1012694|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
1012695|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
1012696|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
1012697|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
1012698|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
1012699|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
1012700|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
1012701|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
1012702|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
1012703|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
1012704|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
1012705|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
1012706|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
1012707|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
1012708|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
1012709|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
1012710|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
1012711|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
1012712|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
1012713|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
1012714|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
1012715|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
1012716|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
1012717|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
1012718|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
1012719|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
1012720|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
1012721|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
1012722|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
1012723|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
1012724|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
1012725|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
1012726|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
1012727|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
1012728|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
1012729|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
1012730|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
1012731|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
1012732|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
1012733|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
1012734|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
1012735|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
1012736|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
1012737|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
1012738|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
1012739|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
1012740|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
1012741|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
1012742|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
1012743|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
1012744|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
1012745|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
1012746|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
1012747|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
1012748|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
1012749|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
1012750|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
1012751|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
1012752|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
1012753|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
1012754|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
1012755|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
1012756|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
1012757|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
1012758|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
1012759|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
1012760|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
1012761|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
1012762|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
1012763|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
1012764|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
1012765|NCT00785577|O4|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
1012766|NCT00785577|O3|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
1012767|NCT00785577|O2|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
1012768|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
1012769|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
1012770|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
1012771|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
1012772|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
1012773|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
1012774|NCT00785577|O5|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg BID po during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
1012775|NCT00785577|O4|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg BID po during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
1012776|NCT00785577|O3|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) BID po for 1 week.
1012777|NCT00785577|O2|Outcome|Pregabalin|Pregabalin thrice daily TID po for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6.
1012778|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
1012779|NCT00785577|O4|Outcome|LY545694 105 mg|LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
1012780|NCT00785577|O3|Outcome|LY545694 49 mg|LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
1012781|NCT00785577|O2|Outcome|LY545694 21 mg|LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week.
1012782|NCT00785577|O1|Outcome|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks.
1012783|NCT00785577|E10|Reported Event|Pregabalin Washout|A one-week washout period in which no pregabalin was taken.
1012784|NCT00785577|E9|Reported Event|LY545694 105 mg Washout|A one-week washout period in which no LY545694 105 mg was taken.
1012785|NCT00785577|E8|Reported Event|LY545694 49 mg Washout|A one-week washout period in which no LY545694 49 mg was taken.
1012786|NCT00785577|E7|Reported Event|LY545694 21 mg Washout|A one-week washout period in which no LY545694 21 mg was taken.
1012787|NCT00785577|E6|Reported Event|Placebo Washout|A one-week washout period in which no placebo was taken.
1012788|NCT00785577|E5|Reported Event|Pregabalin|Pregabalin thrice daily (TID) oral (po) for 6 weeks: 50 mg TID po for Week 1, 100 mg TID po for Weeks 2 - 5, and 50 mg TID po taper for Week 6
1012789|NCT00785577|E4|Reported Event|LY545694 105 mg|LY545694 escalated to 105 mg twice daily (BID) oral (po) during Week 3 through Week 5; possible titration down to 49 mg BID po within 1 week of escalation for the remainder of study treatment.
1012790|NCT00785577|E3|Reported Event|LY545694 49 mg|LY545694 escalated to 49 mg twice daily (BID) oral (po) during Week 2; possible titration down to 21 mg BID po within 1 week of escalation for remainder of study treatment.
1012791|NCT00785577|E2|Reported Event|LY545694 21 mg|LY545694 21 milligrams (mg) twice daily (BID) oral (po) for 1 week
1012792|NCT00785577|E1|Reported Event|Placebo|LY545694 placebo twice daily (BID) oral (po) for 5 weeks and pregabalin placebo capsules three times daily (TID) po for 6 weeks
1012793|NCT00785512|B3|Baseline|Total|Total of all reporting groups
1012794|NCT00785512|B2|Baseline|Placebo|Matching placebo tablets, oral administration
1012795|NCT00785512|B1|Baseline|Nebivolol|Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
1012796|NCT00785512|P2|Participant Flow|Placebo|Matching placebo tablets, oral administration
1012797|NCT00785512|P1|Participant Flow|Nebivolol|Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
1012798|NCT00785512|O2|Outcome|Placebo|Matching placebo tablets, oral administration
1012799|NCT00785512|O1|Outcome|Nebivolol|Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
1012801|NCT00785512|O1|Outcome|Nebivolol|Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
1012802|NCT00785512|E3|Reported Event|Placebo|Matching placebo tablets, oral administration
1012803|NCT00785512|E2|Reported Event|Nebivolol|Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration
1012804|NCT00785512|E1|Reported Event|Single-blind Nebivolol|Pre-randomization 12 week nebivolol treatment.
1012805|NCT00785486|B1|Baseline|Qualaquin (Quinine) And Midazolam Alone And In Combination|All pharmacokinetic studies were begun after a fast of at least 10 hours. On day 1 all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times sufficient to define the baseline kinetics of midazolam and 1-hydroxy-midazolam. After a 3 day washout period, on the morning of day 4, all participants began a regimen of 324 mg of quinine sulfate orally every 8 hours for a total of 21 doses. On day 9 after taking Qualaquin (quinine) for 5 days according to the stated regimen all participants took their usual dose of Qualaquin (quinine). Blood was drawn sufficient to characterize the steady state kinetics of quinine. On day 10 after taking Qualaquin (quinine) for 6 days according to the stated regimen, all participants took their usual dose of Qualaquin (quinine) with an oral dose of midazolam 2 mg. Blood was drawn sufficient to characterize the steady state kinetics of quinine and the kinetics of midazolam and 1-hydroxy-midazolam in the presence of each other.
1012806|NCT00785486|P1|Participant Flow|Qualaquin (Quinine) And Midazolam Alone And In Combination|All pharmacokinetic studies were begun after a fast of at least 10 hours. On day 1 all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times sufficient to define the baseline kinetics of midazolam and 1-hydroxy-midazolam. After a 3 day washout period, on the morning of day 4, all participants began a regimen of 324 mg of quinine sulfate orally every 8 hours for a total of 21 doses. On day 9 after taking Qualaquin (quinine) for 5 days according to the stated regimen all participants took their usual dose of Qualaquin (quinine). Blood was drawn sufficient to characterize the steady state kinetics of quinine. On day 10 after taking Qualaquin (quinine) for 6 days according to the stated regimen, all participants took their usual dose of Qualaquin (quinine) with an oral dose of midazolam 2 mg. Blood was drawn sufficient to characterize the steady state kinetics of quinine and the kinetics of midazolam and 1-hydroxy-midazolam in the presence of each other.
1012807|NCT00785486|O2|Outcome|Qualaquin (Quinine) With Midazolam|On day 10 after six days of receiving Qualaquin 324 mg every 8 hours, and after a fast of at least 10 hours, patients received a 2 mg dose of midazolam and 324 mg of Qualaquin (quinine)(Steady state). Blood was drawn sufficient to determine the pharmacokinetics of Qualaquin(quinine) in the presence of midazolam over the final dosing interval (0 – 8 hours), as calculated by the linear trapezoidal method.
1012808|NCT00785486|O1|Outcome|Qualaquin (Quinine) Alone|On the morning of day 9 after taking an oral dose of Qualaquin quinine)324 mg every 8 hours for the prior 5 days (Steady state) and following a fast of at least 10 hours all participants took a an additional 324 mg oral dose of the drug. Blood was drawn sufficient to determine the pharmacokinetics of Qualaquin(Quinine) alone over the following dosing interval (0 – 8 hours), as calculated by the linear trapezoidal method.
1012809|NCT00785486|O4|Outcome|1-Hydroxy-Midazolam -Midazolam With Qualaquin (Quinine)|On day 10 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg and Qualaquin(quinine) 324 mg. Blood was drawn sufficient to characterize AUC inf for 1- hydroxy-midazolam alone calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant
1012810|NCT00785486|O3|Outcome|Midazolam - Midazolam With Qualaquin (Quinine)|On day 10 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg and Qualaquin (quinine) 324 mg . Blood was drawn sufficient to characterize AUC inf for midazolam alone calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant
1012811|NCT00785486|O2|Outcome|1-Hydroxy-Midazolam - Midazolam Alone|On day 1 after a fast of at least 10 hours all participants received a single oral dose of midazolam 2 mg. Blood was drawn sufficient to characterize AUC inf for 1-hydroxy-midazolam alone calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant.
1012812|NCT00785486|O1|Outcome|Midazolam - Midazolam Alone|On day 1 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg. Blood was drawn sufficient to characterize AUC inf for midazolam alone calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant
1012813|NCT00785486|O4|Outcome|1-Hydroxy-Midazolam -Midazolam With Qualaquin (Quinine)|On day 10 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg and Qualaquin (quinine) 324 mg. Blood was drawn at times sufficient to characterize the Area under the concentration time curve from zero to 24 hours (AUC 0-t) for 1-hydroxy midazolam in the presence of Qualaquin(quinine)at steady state as calculated by the linear trapezoidal method.
1012814|NCT00785486|O3|Outcome|Midazolam - Midazolam With Qualaquin (Quinine)|On day 10 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg and Qualaquin (quinine) 324 mg. Blood was drawn at times sufficient to characterize the Area under the concentration time curve from zero to 24 hours (AUC 0-t) for midazolam in the presence of Qualaquin(quinine)at steady state as calculated by the linear trapezoidal method.
1012815|NCT00785486|O2|Outcome|1-Hydroxy-Midazolam - Midazolam Alone|On day 1 after a fast of at least 10 hours all partcipants received a single oral dose of midazolam 2 mg. Blood was drawn at times sufficient to characterize the Area under the concentration time curve from zero to 24 hours (AUC 0-t) of 1-hydroxy midazolam as calculated by the linear trapezoidal method.
1012816|NCT00785486|O1|Outcome|Midazolam - Midazolam Alone|On day 1 after a fast of at least 10 hours all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times sufficient to characterize the Area under the concentration time curve from zero to 24 hours (AUC 0-t) of midazolam and 1-hydroxymidazolam
1012817|NCT00785486|O6|Outcome|Quinine - Qualaquin (Quinine) With Midazolam|On the morning of day 10 after taking Qualaquin (quinine)capsules 324 mg orally every 8 hours for the prior 6 days, and following a fast of at least 10 hours all study participants co-ingested oral dose s of midazolam 2 mg and their usual morning dose of Qualaquin (quinine)324 mg. Blood was drawn at times 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, and 7.917 hours to determine the steady state Cmax for Qualaquin (quinine)in the presence of midazolam.
1012818|NCT00785486|O5|Outcome|1-Hydroxy-Midazolam -Midazolam With Qualaquin(Quinine)|On the morning of day 10, after a fast of at least 10 hours all study participants received an oral dose of both midazolam 2 mg and Qualaquin(quinine)324 mg concurrently. On day 1 after a fast of at least 10 hours all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times 0, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917, 12, 15 and 24 hours to determine the Cmax for 1-hydroxy-midazolam in the presence of Qualaquin (quinine) at steady state.
1012819|NCT00785486|O4|Outcome|Midazolam - Midazolam With Qualaquin(Quinine)|On the morning of day 10, after a fast of at least 10 hours all study participants received an oral dose of both midazolam 2 mg and Qualaquin(quinine)324 mg. Blood was drawn at times 0, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917. 12, 15 and 24 hours to determine Cmax for midazolam in the presence of Qualaquin (qunine)at steady state.
1012820|NCT00785486|O3|Outcome|Quinine - Qualaquin(Quinine) Alone|On the morning of day 9 after taking Qualaquin(quinine)capsules 324 mg orally every 8 hours for the prior 5 days, and following a fast of at least 10 hours all study participants received their usual morning dose of Qualaquin (quinine)324 mg. Blood was drawn at times 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, and 7.917 hours to determine the steady state Cmax for Qualaquin (quinine) at this dose.
1012821|NCT00785486|O2|Outcome|1-Hydroxy-Midazolam - Midazolam Alone|On day 1 after a fast of at least 10 hours all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times 0, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917, 12, 15 and 24 hours to determine the baseline Cmax for 1-hydroxy-midazolam, the primary metabolite of midazolam
1012822|NCT00785486|O1|Outcome|Midazolam - Midazolam Alone|On day 1 after a fast of at least 10 hours all participants received a single oral dose of midazolam 2 mg. Blood was drawn at times 0, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917, 12, 15 and 24 hours to determine the baseline Cmax for midazolam.
1012823|NCT00785486|E3|Reported Event|Midazolam With Qualaquin (Quinine) Together|Adverse effects reported on day 10 after participants received 2 mg of midazolam syrup and 324 mg of Qualaquin(quinine)orally.
1012824|NCT00785486|E2|Reported Event|Qualaquin (Quinine) Alone|Adverse effects(ADR)while taking Qualaquin(quinine)324 mg alone orally every 8 hours on days 4-11. Results are reported as total for the 7 day period.
1012825|NCT00785486|E1|Reported Event|Midazolam Alone|Adverse effects on day 1 after participants received 2mg of midazolam syrup orally.
1012826|NCT00785356|B4|Baseline|Total|Total of all reporting groups
1012827|NCT00785356|B3|Baseline|Placebo|Placebo: Placebo, 2 capsules daily for 3 months
1012828|NCT00785356|B2|Baseline|Proellex 50 mg|Proellex 50 mg: Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
1012829|NCT00785356|B1|Baseline|25 mg Proellex|Proellex 25 mg: Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
1012830|NCT00785356|P1|Participant Flow|All Groups|Proellex 25 mg, Proellex 50 mg, 1placebo
1012831|NCT00785356|O3|Outcome|Placebo|Placebo: Placebo, 2 capsules daily for 3 months
1012832|NCT00785356|O2|Outcome|Proellex 50 mg|Proellex 50 mg: Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
1012833|NCT00785356|O1|Outcome|25 mg Proellex|Proellex 25 mg: Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
1012834|NCT00785356|E3|Reported Event|Placebo|Placebo: Placebo, 2 capsules daily for 3 months
1012835|NCT00785356|E2|Reported Event|Proellex 50 mg|Proellex 50 mg: Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
1012836|NCT00785356|E1|Reported Event|25 mg Proellex|Proellex 25 mg: Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
1012837|NCT00785291|B4|Baseline|Total|Total of all reporting groups
1012838|NCT00785291|B3|Baseline|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
1012839|NCT00785291|B2|Baseline|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
1012840|NCT00785291|B1|Baseline|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
1012841|NCT00785291|P3|Participant Flow|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
1012842|NCT00785291|P2|Participant Flow|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
1012843|NCT00785291|P1|Participant Flow|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
1012844|NCT00785291|O3|Outcome|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
1012845|NCT00785291|O2|Outcome|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
1012846|NCT00785291|O1|Outcome|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
1012847|NCT00785291|O3|Outcome|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
1012848|NCT00785291|O2|Outcome|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
1012907|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
1012849|NCT00785291|O1|Outcome|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
1012850|NCT00785291|O3|Outcome|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
1012851|NCT00785291|O2|Outcome|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
1012852|NCT00785291|O1|Outcome|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
1012853|NCT00785291|O3|Outcome|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
1012854|NCT00785291|O2|Outcome|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
1012855|NCT00785291|O1|Outcome|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
1012856|NCT00785291|O3|Outcome|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
1012857|NCT00785291|O2|Outcome|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
1012858|NCT00785291|O1|Outcome|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
1012859|NCT00785291|E3|Reported Event|Arm C (Ixabepilone)|Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
1012860|NCT00785291|E2|Reported Event|Arm B (Nab-paclitaxel)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
1012861|NCT00785291|E1|Reported Event|Arm A (Paclitaxel)|Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
1012862|NCT00785213|B1|Baseline|Rosiglitazone Alone, Quinine Alone, Rosiglitazone With Quinine|On the morning of Day 1, subjects received a single dose of rosiglitazone (1 x 4 mg tablet) after an overnight fast of at least 10 hours, followed by a 2 day washout period. On Days 4-7, subjects received a dose of quinine sulfate (2 x 324 mg capsules) every 8 hours beginning at 7:15 am on Day 4 and continuing through the 11:15 p.m. dose on Day 7. On the morning of Day 7, subjects received a single dose of rosiglitazone (1 x 4 mg tablet) along with the morning dose of quinine sulfate ( 2 x 324 mg capsules).
1012863|NCT00785213|P1|Participant Flow|Rosiglitazone Alone, Quinine Alone, Rosiglitazone With Quinine|On the morning of Day 1, subjects received a single dose of rosiglitazone (1 x 4 mg tablet) after an overnight fast of at least 10 hours, followed by a 2 day washout period. On Days 4-7, subjects received a dose of quinine sulfate (2 x 324 mg capsules) every 8 hours beginning at 7:15 am on Day 4 and continuing through the 11:15 p.m. dose on Day 7. On the morning of Day 7, subjects received a single dose of rosiglitazone (1 x 4 mg tablet) along with the morning dose of quinine sulfate ( 2 x 324 mg capsules).
1012864|NCT00785213|O2|Outcome|Rosiglitazone With Quinine Sulfate|On the morning of Day 7, subjects received a co-administered single oral dose of rosiglitazone 4 mg and quinine sulfate 648 mg after an overnight fast.
1012865|NCT00785213|O1|Outcome|Rosiglitazone Alone|On the morning of Day 1, subjects received a single dose of rosiglitazone 4 mg after an overnight fast of at least 10 hours, followed by a 2 day washout period.
1012866|NCT00785213|O2|Outcome|Rosiglitazone With Quinine Sulfate|On the morning of Day 7, subjects received a co-administered single oral dose of rosiglitazone 4 mg and quinine sulfate 648 mg after an overnight fast.
1012867|NCT00785213|O1|Outcome|Rosiglitazone Alone|On the morning of Day 1, subjects received a single dose of rosiglitazone 4 mg after an overnight fast of at least 10 hours, followed by a 2 day washout period.
1012868|NCT00785213|O2|Outcome|Rosiglitazone With Quinine Sulfate|On the morning of Day 7, subjects received a co-administered single oral dose of rosiglitazone 4 mg and quinine sulfate 648 mg after an overnight fast.
1012869|NCT00785213|O1|Outcome|Rosiglitazone Alone|On the morning of Day 1, subjects received a single dose of rosiglitazone 4 mg after an overnight fast of at least 10 hours, followed by a 2 day washout period.
1012870|NCT00785213|E3|Reported Event|Rosiglitazone With Quinine Sulfate|On the morning of Day 7, subjects were co-administered a dose of rosiglitazone 4mg and quinine sulfate 648 mg (2 x 324 mg capsules) following an overnight fast of at least 10 hours.
1012871|NCT00785213|E2|Reported Event|Quinine Sulfate Alone|On Days 4-7, subjects received a dose of quinine sulfate 648 mg (2 x 324 mg capsules) every 8 hours beginning with the 7:15 a.m. dose on Day 4 and continuing through the 11:15 p.m. dose on Day 7.
1012872|NCT00785213|E1|Reported Event|Rosiglitazone Alone|On the morning of Day 1, subjects received a single dose of rosiglitazone (1 x 4 mg tablet) after an overnight fast of at least 10 hours, followed by a 2 day washout period.
1012873|NCT00785044|B1|Baseline|AdreView™ - Heart Failure Group|HF participants administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were monitored for up to 24 months at 6-month intervals from the date of administration of 123I-mIBG to assess the occurrence of ACEs.
1012908|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
1012874|NCT00785044|P1|Participant Flow|AdreView™- Heart Failure Group|HF participants administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were monitored for up to 24 months at 6-month intervals from the date of administration of 123I-mIBG to assess the occurrence of adverse cardiac events (ACEs).
1012875|NCT00785044|O2|Outcome|AdreView™- HF Group (With Adverse Cardiac Events)|HF participants administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) with ACEs monitored for up to 24 months at 6-month intervals from the date of administration of 123I-mIBG.
1012876|NCT00785044|O1|Outcome|AdreView™ - HF Group (With No Adverse Cardiac Events)|HF participants administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) with no ACEs monitored for up to 24 months at 6-month intervals from the date of administration of 123I-mIBG.
1012877|NCT00785044|E1|Reported Event|AdreView™ - Heart Failure Group|HF participants administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were monitored for up to 24 months at 6-month intervals from the date of administration of 123I-mIBG to assess the occurrence of ACEs.
1012878|NCT00784979|B1|Baseline|Highly Sensitized Patients|Highly-sensitized patients were defined as those having PRA >/= 20% within the last 12 months; identification of donor-specific antibody or, any combination of Class I and/or Class 2 HLA incompatibility.
1012879|NCT00784979|P1|Participant Flow|CMVIG Followed by PP|MMF or rapamycin was given with CMVIG for 4 weeks followed by plasmapheresis
1012880|NCT00784979|O1|Outcome|Highly Sensitized Patients|Highly-sensitized patients were defined as those having PRA greater than or equal to 20 percent within the last 12 months, identification of donor-specific antibody or, any combination of Class I and/or Class 2 HLA incompatibility.
1012881|NCT00784979|E1|Reported Event|Highly Sensitized Patients|Highly-sensitized patients were defined as those having PRA greater than or equal to 20 percent within the last 12 months, identification of donor-specific antibody or, any combination of Class I and/or Class 2 HLA incompatibility.
1012882|NCT00784927|B1|Baseline|Treatment|"Participants with symptomatic untreated low grade NHL will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles:~375 mg/m^2 Rituximab IV on day 1.~20 mg Lenalidomide taken orally on days 1-21.~250 mg/m^2 Cyclophosphamide orally on days 1, 8, 15.~40 mg Dexamethasone orally on days 1, 8, 15, 22."
1012883|NCT00784927|P1|Participant Flow|Treatment|"Participants with symptomatic untreated low grade NHL will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles:~375 mg/m^2 Rituximab IV on day 1. 20 mg Lenalidomide taken orally on days 1-21.~250 mg/m^2 Cyclophosphamide orally on days 1, 8, 15.~40 mg Dexamethasone orally on days 1, 8, 15, 22."
1012884|NCT00784927|O1|Outcome|Treatment|"Participants with symptomatic untreated low grade NHL will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles:~375 mg/m^2 Rituximab IV on day 1. 20 mg Lenalidomide taken orally on days 1-21. 250 mg/m^2 Cyclophosphamide orally on days 1, 8, 15. 40 mg Dexamethasone orally on days 1, 8, 15, 22."
1012885|NCT00784927|O1|Outcome|Treatment|"Participants with symptomatic untreated low grade NHL will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles:~375 mg/m^2 Rituximab IV on day 1. 20 mg Lenalidomide taken orally on days 1-21. 250 mg/m^2 Cyclophosphamide orally on days 1, 8, 15. 40 mg Dexamethasone orally on days 1, 8, 15, 22."
1012886|NCT00784927|O1|Outcome|Treatment|"Participants with symptomatic untreated low grade NHL will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles:~375 mg/m^2 Rituximab IV on day 1. 20 mg Lenalidomide taken orally on days 1-21. 250 mg/m^2 Cyclophosphamide orally on days 1, 8, 15. 40 mg Dexamethasone orally on days 1, 8, 15, 22."
1012887|NCT00784927|O1|Outcome|Treatment|"Participants with lymphoplasmacytic lymphoma (Waldenstrom’s macroglobulinemia) will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles and analyzed as a separate cohort:~375 mg/m^2 Rituximab IV on day 1. 20 mg Lenalidomide taken orally on days 1-21. 250 mg/m^2 Cyclophosphamide orally on days 1, 8, 15. 40 mg Dexamethasone orally on days 1, 8, 15, 22.~rituximab~cyclophosphamide~dexamethasone~lenalidomide"
1012888|NCT00784927|O1|Outcome|Treatment|"Participants with symptomatic untreated low grade NHL will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles:~375 mg/m^2 Rituximab IV on day 1. 20 mg Lenalidomide taken orally on days 1-21. 250 mg/m^2 Cyclophosphamide orally on days 1, 8, 15. 40 mg Dexamethasone orally on days 1, 8, 15, 22."
1012889|NCT00784927|E1|Reported Event|Treatment|40 mg Dexamethasone orally on days 1, 8, 15, 22.
1012890|NCT00784875|B5|Baseline|Total|Total of all reporting groups
1012891|NCT00784875|B4|Baseline|Placebo|Participants received placebo in Period B (2-week treatment period).
1012892|NCT00784875|B3|Baseline|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
1012893|NCT00784875|B2|Baseline|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
1012894|NCT00784875|B1|Baseline|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
1012895|NCT00784875|P4|Participant Flow|Placebo|Participants received placebo in a 2-week treatment period.
1012896|NCT00784875|P3|Participant Flow|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
1012897|NCT00784875|P2|Participant Flow|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
1012898|NCT00784875|P1|Participant Flow|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
1012899|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
1012900|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
1012901|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
1012902|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
1012903|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
1012904|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
1012905|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
1012906|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period
1022407|NCT00762788|O5|Outcome|Comfilcon A Contact Lens|Biofinity
1012909|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
1012910|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
1012911|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
1012912|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
1012913|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
1012914|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
1012915|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
1012916|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
1012917|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
1012918|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
1012919|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
1012920|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
1012921|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
1012922|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
1012923|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
1012924|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
1012925|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
1012926|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
1012927|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
1012928|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
1012929|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
1012930|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
1012931|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
1012932|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
1012933|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
1012934|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
1012935|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
1012936|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
1012937|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
1012938|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
1012939|NCT00784875|O4|Outcome|Placebo|Participants received placebo in a 2-week treatment period.
1012940|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in a 2-week treatment period.
1012941|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in a 2-week treatment period.
1012942|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in a 2-week treatment period.
1012943|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
1012944|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
1012945|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
1012946|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
1012947|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
1012948|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
1012949|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
1012950|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
1012951|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
1012952|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
1012953|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
1012954|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
1012955|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
1012956|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
1012957|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
1012958|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
1012959|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
1012960|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
1012961|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
1012962|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
1012963|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
1012964|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
1012965|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
1012966|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
1012967|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
1012968|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
1012969|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
1012970|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
1012971|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
1012972|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
1012973|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
1012974|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
1012975|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
1012976|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
1012977|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
1012978|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
1012979|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
1012980|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
1012981|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
1012982|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
1012983|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
1012984|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
1012985|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
1012986|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
1012987|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
1012988|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
1012989|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
1012990|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
1012991|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
1012992|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
1012993|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
1012994|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
1012995|NCT00784875|O4|Outcome|Placebo|Participants received placebo in Period B (2-week treatment period).
1012996|NCT00784875|O3|Outcome|Zolpidem 5 or 10 mg|Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
1012997|NCT00784875|O2|Outcome|LY2624803 3 mg|Participants received LY2624803 3 mg in Period B (2-week treatment period).
1012998|NCT00784875|O1|Outcome|LY2624803 1 mg|Participants received LY2624803 1 mg in Period B (2-week treatment period).
1012999|NCT00784875|E12|Reported Event|Period D - Zolpidem 5 or 10 mg|Patients received Zolpidem 5 or 10 mg in Period D (2-week treatment period).
1013000|NCT00784875|E11|Reported Event|Period D - Placebo|Patients received placebo in Period D (2-week treatment period).
1013001|NCT00784875|E10|Reported Event|Period D - LY2624803 3 mg|Patients received LY2624803 3 mg in Period D (2-week treatment period).
1013002|NCT00784875|E9|Reported Event|Period D - LY2624803 1 mg|Patients received LY2624803 1 mg in Period D (2-week treatment period.
1013003|NCT00784875|E8|Reported Event|Period C - Zolpidem 5 or 10 mg|Patients received Zolpidem 5 or 10 mg in Period C (2-week treatment period).
1013004|NCT00784875|E7|Reported Event|Period C - Placebo|Patients received placebo in Period C (2-week treatment period).
1013005|NCT00784875|E6|Reported Event|Period C - LY2624803 3 mg|Patients received LY2624803 3 mg in Period C (2-week treatment period).
1013006|NCT00784875|E5|Reported Event|Period C - LY2624803 1 mg|Patients received LY2624803 1 mg in Period C (2-week treatment period.
1013007|NCT00784875|E4|Reported Event|Period B - Zolpidem 5 or 10 mg|Patients received Zolpidem 5 or 10 mg in Period B (2-week treatment period).
1013008|NCT00784875|E3|Reported Event|Period B - Placebo|Patients received placebo in Period B (2-week treatment period).
1013009|NCT00784875|E2|Reported Event|Period B - LY2624803 3 mg|Patients received LY2624803 3 mg in Period B (2-week treatment period).
1013010|NCT00784875|E1|Reported Event|Period B - LY2624803 1 mg|Patients received LY2624803 1 mg in Period B (2-week treatment period.
1013011|NCT00784849|B1|Baseline|Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue|One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
1013012|NCT00784849|P1|Participant Flow|Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue|One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
1013013|NCT00784849|O1|Outcome|Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue|One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
1013014|NCT00784849|O1|Outcome|Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue|One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
1013015|NCT00784849|O1|Outcome|Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue|One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
1013016|NCT00784849|E1|Reported Event|Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue|One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
1013017|NCT00784836|B1|Baseline|Avonex|Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
1013018|NCT00784836|P1|Participant Flow|Avonex|Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
1013019|NCT00784836|O1|Outcome|Avonex|Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
1013020|NCT00784836|O1|Outcome|Avonex|Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
1013021|NCT00784836|E1|Reported Event|Avonex|Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
1013022|NCT00784810|B3|Baseline|Total|Total of all reporting groups
1013023|NCT00784810|B2|Baseline|Codeine/Paracetamol Tablets|Codeine/Paracetamol 15/500 and 30/500 mg
1013024|NCT00784810|B1|Baseline|Oxycodone/Naloxone Tablets (OXN)|Oxycodone/Naloxone (OXN) tablets 5,10 and 20 mg
1013025|NCT00784810|P2|Participant Flow|Codeine/Paracetamol Tablets|Codeine/Paracetamol 15/500 and 30/500 mg
1013026|NCT00784810|P1|Participant Flow|Oxycodone/Naloxone Tablets (OXN)|Oxycodone/Naloxone (OXN) tablets 5,10 and 20 mg
1013027|NCT00784810|O2|Outcome|Codeine/Paracetamol Tablets|Codeine/Paracetamol 15/500 and 30/500 mg
1013028|NCT00784810|O1|Outcome|Oxycodone/Naloxone Tablets (OXN)|Oxycodone/Naloxone (OXN) tablets 5,10 and 20 mg
1013029|NCT00784810|O2|Outcome|Codeine/Paracetamol Tablets|Codeine/Paracetamol 15/500 and 30/500 mg
1013030|NCT00784810|O1|Outcome|Oxycodone/Naloxone Tablets (OXN)|Oxycodone/Naloxone (OXN) tablets 5,10 and 20 mg
1013031|NCT00784810|E2|Reported Event|Codeine/Paracetamol Tablets|Codeine/Paracetamol 15/500 and 30/500 mg
1013032|NCT00784810|E1|Reported Event|Oxycodone/Naloxone Tablets (OXN)|Oxycodone/Naloxone (OXN) tablets 5,10 and 20 mg
1013033|NCT00784784|B3|Baseline|Total|Total of all reporting groups
1013034|NCT00784784|B2|Baseline|Antiviral Prophylaxis|Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis
1013035|NCT00784784|B1|Baseline|Influenza Vaccine|Influenza vaccine, using Fluviral trivalent split virus vaccine
1013036|NCT00784784|P2|Participant Flow|Antiviral Prophylaxis|Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis
1013037|NCT00784784|P1|Participant Flow|Influenza Vaccine|Influenza vaccine, using Fluviral trivalent split virus vaccine
1013038|NCT00784784|O2|Outcome|Antiviral Prophylaxis|Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis
1013039|NCT00784784|O1|Outcome|Influenza Vaccine|Influenza vaccine, using Fluviral trivalent split virus vaccine
1013040|NCT00784784|O2|Outcome|Antiviral Prophylaxis|Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis
1013041|NCT00784784|O1|Outcome|Influenza Vaccine|Influenza vaccine, using Fluviral trivalent split virus vaccine
1013042|NCT00784784|E2|Reported Event|Antiviral Prophylaxis|Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis
1013043|NCT00784784|E1|Reported Event|Influenza Vaccine|Influenza vaccine, using Fluviral trivalent split virus vaccine
1013044|NCT00784719|B8|Baseline|Total|Total of all reporting groups
1013045|NCT00784719|B7|Baseline|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
1013046|NCT00784719|B6|Baseline|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
1013047|NCT00784719|B5|Baseline|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
1013048|NCT00784719|B4|Baseline|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
1013049|NCT00784719|B3|Baseline|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
1013050|NCT00784719|B2|Baseline|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
1013051|NCT00784719|B1|Baseline|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
1013052|NCT00784719|P7|Participant Flow|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
1013053|NCT00784719|P6|Participant Flow|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
1013054|NCT00784719|P5|Participant Flow|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
1013055|NCT00784719|P4|Participant Flow|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
1013056|NCT00784719|P3|Participant Flow|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
1013057|NCT00784719|P2|Participant Flow|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
1013058|NCT00784719|P1|Participant Flow|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
1013059|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
1013060|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
1013061|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
1013062|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
1013063|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
1013064|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
1013065|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
1013066|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
1013295|NCT00784550|O2|Outcome|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
1013067|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
1013068|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
1013069|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
1013070|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
1013071|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
1013072|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
1013073|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
1013074|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
1013075|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
1013076|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
1013077|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
1013078|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
1013079|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
1013080|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
1013081|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
1013082|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
1013083|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
1013084|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
1013085|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
1013086|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
1013087|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
1013088|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
1013089|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
1013090|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
1013091|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
1013092|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
1013093|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
1013094|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
1013095|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
1013096|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
1013097|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
1013098|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
1013099|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
1013100|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
1013101|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
1013102|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
1013103|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
1013104|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
1013105|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
1013106|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
1013107|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
1013108|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
1013297|NCT00784550|O2|Outcome|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
1013109|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
1013110|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
1013111|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
1013112|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
1013113|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
1013114|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
1013115|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
1013116|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
1013117|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
1013118|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
1013119|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
1013120|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
1013121|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
1013122|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
1013123|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
1013124|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
1013125|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
1013126|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
1013127|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
1013128|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
1013129|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
1013130|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
1013131|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
1013132|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
1013133|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
1013134|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
1013135|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
1013136|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
1013137|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
1013138|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
1013139|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
1013140|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
1013141|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
1013142|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
1013143|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
1013144|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
1013145|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
1013146|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
1013147|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
1013148|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
1013149|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
1013150|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
1013546|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1022408|NCT00762788|O4|Outcome|Balafilcon A Contact Lens|PureVision
1013151|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
1013152|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
1013153|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
1013154|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
1013155|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
1013156|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
1013157|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
1013158|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
1013159|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
1013160|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
1013161|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
1013162|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
1013163|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
1013164|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
1013165|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
1013166|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
1013167|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
1013168|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
1013169|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
1013170|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
1013171|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
1013172|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
1013173|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
1013174|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
1013175|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
1013176|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
1013177|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
1013178|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
1013179|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
1013180|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
1013181|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
1013182|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
1013183|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
1013184|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
1013185|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
1013186|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
1013187|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
1013188|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
1013189|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
1013190|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
1013191|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
1013192|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
1013547|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1022409|NCT00762788|O3|Outcome|Lotrafilcon B Contact Lens|O2Optix
1013193|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
1013194|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
1013195|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
1013196|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
1013197|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
1013198|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
1013199|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
1013200|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
1013201|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
1013202|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
1013203|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
1013204|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
1013205|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
1013206|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
1013207|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
1013208|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
1013209|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
1013210|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
1013211|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
1013212|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
1013213|NCT00784719|O7|Outcome|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
1013214|NCT00784719|O6|Outcome|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
1013215|NCT00784719|O5|Outcome|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
1013216|NCT00784719|O4|Outcome|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
1013217|NCT00784719|O3|Outcome|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
1013218|NCT00784719|O2|Outcome|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
1013219|NCT00784719|O1|Outcome|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
1013220|NCT00784719|E7|Reported Event|Restasis Twice Daily|One drop (45 mcL) of Restasis (cyclosporine) 0.05% ophthalmic emulsion twice daily in each eye for 8 weeks.
1013221|NCT00784719|E6|Reported Event|CP-690,550, 0.005% Once Daily|One drop (45 mcL) of 0.005% CP-690,550 solution once daily in the morning in each eye and 1 drop of matching placebo once daily in the evening in each eye for 8 weeks.
1013222|NCT00784719|E5|Reported Event|CP-690,550, 0.005% Twice Daily|One drop (45 mcL) of 0.005% CP-690,550 solution twice daily in each eye for 8 weeks.
1013223|NCT00784719|E4|Reported Event|CP-690,550, 0.003% Twice Daily|One drop (45 mcL) of 0.003% CP-690,550 solution twice daily in each eye for 8 weeks.
1013224|NCT00784719|E3|Reported Event|CP-690,550, 0.001% Twice Daily|One drop (45 mcL) of 0.001% CP-690,550 solution twice daily in each eye for 8 weeks.
1013225|NCT00784719|E2|Reported Event|CP-690,550, 0.0003% Twice Daily|One drop (45 mcL) of 0.0003 percent (%) CP-690,550 solution twice daily in each eye for 8 weeks.
1013226|NCT00784719|E1|Reported Event|Placebo Twice Daily|One drop (45 microliter [mcL]) of matching placebo solution twice daily in each eye for 8 weeks.
1013227|NCT00784654|B1|Baseline|All Enrolled Subjects|
1013228|NCT00784654|P3|Participant Flow|Placebo (Randomized Period)|After the Open-label Period, subjects were randomized to receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
1013229|NCT00784654|P2|Participant Flow|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|After the Open-label Period, subjects were randomized to receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
1013230|NCT00784654|P1|Participant Flow|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours).
1013231|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
1013232|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
1013548|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013233|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours ).
1013234|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
1013235|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
1013236|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
1013237|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
1013238|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours ).
1013239|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
1013240|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
1013241|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours).
1013242|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
1013243|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
1013244|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours ).
1013245|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
1013246|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
1013247|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours).
1013248|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours).
1013249|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
1013250|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
1013251|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours ).
1013252|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours).
1013253|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
1013254|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for up to 6 weeks.
1013255|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours).
1013256|NCT00784654|O2|Outcome|Placebo (Randomized Period)|Subjects receive placebo once-daily orally at approximately 7:00 AM +/- 2 hours for 6 weeks.
1013257|NCT00784654|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|Subjects receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM +/- 2 hours for 6 weeks.
1013258|NCT00784654|E3|Reported Event|Placebo (Randomized Period)|After the Open-label Period, subjects were randomized to receive placebo once-daily orally at approximately 7:00 AM for up to 6 weeks.
1013259|NCT00784654|E2|Reported Event|Lisdexamfetamine Dimesylate (LDX)(Randomized Period)|After the Open-label Period, subjects were randomized to receive their optimal dose of LDX at either 30, 50, or 70 mg once-daily orally at approximately 7:00 AM for up to 6 weeks.
1013296|NCT00784550|O1|Outcome|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
1022410|NCT00762788|O2|Outcome|Lotrafilcon A Contact Lens|NIGHT&DAY
1013260|NCT00784654|E1|Reported Event|Lisdexamfetamine Dimesylate (LDX)(Open-label Period)|Consists of at least 26 weeks where subjects are titrated to an optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM) and then maintained on their optimal dose of LDX (either 30, 50 or 70 mg once-daily orally at approximately 7:00 AM).
1013261|NCT00784563|B4|Baseline|Total|Total of all reporting groups
1013262|NCT00784563|B3|Baseline|Continuous-Year 3|Participants who were assigned to continuous training in the third year of the study without randomization. Due to potentially increased risk of knee pain without additional fitness benefits, we dropped the interval group for the third year.
1013263|NCT00784563|B2|Baseline|Interval Training -Years 1 & 2|Participants who were randomized to interval training in the first 2 years of the study.
1013264|NCT00784563|B1|Baseline|Continuous Training-Years 1 & 2|Participants who were randomized to continuous training in the first 2 years of the study.
1013265|NCT00784563|P3|Participant Flow|Continuous Training - Year 3|Participant were assigned to continuous training without randomization.
1013266|NCT00784563|P2|Participant Flow|Interval Training - Years 1 & 2|The duration of exercise sessions (3x/week) was advanced from 15 to 45 minutes over the first 6 weeks. Participants were asked to wear electronic heart rate and walking speed monitors (Polar RS400, Kempele, Finland) and fill out diaries for each session. Interval trainees alternated every 3 minutes between slower (60-70% of HRmax) and faster (80-90% of HRmax) walking.
1013267|NCT00784563|P1|Participant Flow|Continuous Training - Years 1 & 2|The duration of exercise sessions (3x/week) was advanced from 15 to 45 minutes over the first 6 weeks. Participants were asked to wear electronic heart rate and walking speed monitors (Polar RS400, Kempele, Finland) and fill out diaries for each session. The goal for continuous training was to remain within 70-80% of HRmax throughout the session.
1013268|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training. Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for analysis.
1013269|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training
1013270|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training. Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for analysis.
1013271|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training. Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for analysis.
1013272|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training
1013273|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training
1013274|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training
1013275|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training
1013276|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training. Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for analysis.
1013277|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training. Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for analysis.
1013278|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training. Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for analysis.
1013279|NCT00784563|O1|Outcome|Completers|The participants who completed 6 months of aerobic training
1013280|NCT00784563|E2|Reported Event|Interval Training|This group consists of 22 subjects who were randomized to interval training in the first two years of the study. No subjects were assigned to the interval training in the third year of the study.
1013281|NCT00784563|E1|Reported Event|Continuous Training|This group consists of 21 subjects who were randomized to continuous training in the first two years of the study and 17 subjects who were assigned to continuous training without randomization in the third year of the study. Thus, total group size is 38.
1013282|NCT00784550|B3|Baseline|Total|Total of all reporting groups
1013283|NCT00784550|B2|Baseline|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
1013284|NCT00784550|B1|Baseline|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
1013285|NCT00784550|P2|Participant Flow|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
1013286|NCT00784550|P1|Participant Flow|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
1013287|NCT00784550|O2|Outcome|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
1013288|NCT00784550|O1|Outcome|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
1013289|NCT00784550|O2|Outcome|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
1013290|NCT00784550|O1|Outcome|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
1013291|NCT00784550|O2|Outcome|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
1013292|NCT00784550|O1|Outcome|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
1013293|NCT00784550|O2|Outcome|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
1013294|NCT00784550|O1|Outcome|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
1022411|NCT00762788|O1|Outcome|Senofilcon A Contact Lens|ACUVUE OASYS
1013298|NCT00784550|O1|Outcome|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
1013299|NCT00784550|E2|Reported Event|Tiotropium|Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
1013300|NCT00784550|E1|Reported Event|FSC + Tio|Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
1013301|NCT00784459|B3|Baseline|Total|Total of all reporting groups
1013302|NCT00784459|B2|Baseline|Treatment With Abatacept|abatacept : Treatment with abatacept, 10 mg/kg IV, for 5 doses.
1013303|NCT00784459|B1|Baseline|Placebo|Placebo : Treatment with Placebo, IV
1013304|NCT00784459|P2|Participant Flow|Treatment With Abatacept|abatacept : Treatment with abatacept, 10 mg/kg IV, for 5 doses.
1013305|NCT00784459|P1|Participant Flow|Placebo|Placebo : Treatment with Placebo, IV
1013306|NCT00784459|O2|Outcome|Treatment With Abatacept|abatacept : Treatment with abatacept, 10 mg/kg IV, for 5 doses.
1013307|NCT00784459|O1|Outcome|Placebo|Placebo : Treatment with Placebo, IV
1013308|NCT00784459|O2|Outcome|Treatment With Abatacept|abatacept : Treatment with abatacept, 10 mg/kg IV, for 5 doses.
1013309|NCT00784459|O1|Outcome|Placebo|Placebo : Treatment with Placebo, IV
1013310|NCT00784459|E2|Reported Event|Treatment With Abatacept|abatacept : Treatment with abatacept, 10 mg/kg IV, for 5 doses.
1013311|NCT00784459|E1|Reported Event|Placebo|Placebo : Treatment with Placebo, IV
1013312|NCT00784368|B4|Baseline|Total|Total of all reporting groups
1013313|NCT00784368|B3|Baseline|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013314|NCT00784368|B2|Baseline|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013315|NCT00784368|B1|Baseline|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013316|NCT00784368|P3|Participant Flow|FN (Switched Treatment)|Participants with febrile (with fever) neutropenia (a decrease in white blood cells) (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013317|NCT00784368|P2|Participant Flow|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous (into the vein) infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013318|NCT00784368|P1|Participant Flow|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013319|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013320|NCT00784368|O2|Outcome|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013321|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013322|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013323|NCT00784368|O2|Outcome|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013339|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013475|NCT00783965|B2|Baseline|Arm II|"Patients apply, vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on months 13-36 once daily to the chest.~placebo : Applied to the skin~tazarotene : Applied to the skin"
1013324|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013325|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013326|NCT00784368|O2|Outcome|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013327|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013328|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013329|NCT00784368|O2|Outcome|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013330|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013331|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013332|NCT00784368|O2|Outcome|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013333|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy + Switched Treatment)|Participants with SFI were allocated either to SFI (ITCZ Oral Solution Monotherapy) or SFI (Switched Treatment). Participants in SFI (ITCZ Oral Solution Monotherapy) group received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion. Participants in SFI (Switched Treatment) were administered 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013334|NCT00784368|O2|Outcome|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013335|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013336|NCT00784368|O2|Outcome|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013337|NCT00784368|O1|Outcome|SFI (JK1211 Monotherapy)|Participants with deep-seated mycosis (SFI) received JK1211 orally (taken by mouth; to be swallowed) in the dose range of 20 milliliter per day (ml/day) to 40 ml/day for 12 weeks as per Investigator’s discretion.
1013338|NCT00784368|O2|Outcome|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013340|NCT00784368|O2|Outcome|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013341|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013342|NCT00784368|O3|Outcome|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013343|NCT00784368|O2|Outcome|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013344|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013345|NCT00784368|O3|Outcome|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013346|NCT00784368|O2|Outcome|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013347|NCT00784368|O1|Outcome|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013348|NCT00784368|E3|Reported Event|FN (Switched Treatment)|Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013349|NCT00784368|E2|Reported Event|SFI (Switched Treatment)|Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013350|NCT00784368|E1|Reported Event|SFI (ITCZ Oral Solution Monotherapy)|Participants with deep-seated mycosis (Systemic Fungal Infection [SFI]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator’s discretion.
1013351|NCT00784277|B5|Baseline|Total|Total of all reporting groups
1013352|NCT00784277|B4|Baseline|Oxycodone|IR Treatment : 10mg capsule for 14 days
1013353|NCT00784277|B3|Baseline|Tapentadol 75 mg|IR Treatment : 75mg capsule for 14 days
1013354|NCT00784277|B2|Baseline|Tapentadol 50 mg|IR Treatment : 50mg capsule for 14 days
1013355|NCT00784277|B1|Baseline|Placebo|IR Treatment : 1 capsule for 14 days
1013356|NCT00784277|P7|Participant Flow|Oxycodone CR|ER Treatment : flexible dose tablets and capsules 2 x a day for 28 days (20-60mg/day)
1013357|NCT00784277|P6|Participant Flow|Tapentadol ER|ER Treatment : flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day)
1013358|NCT00784277|P5|Participant Flow|Placebo ER|ER Treatment : Tablets and capsules 2 x a day for 28 days
1013359|NCT00784277|P4|Participant Flow|Oxycodone|IR Treatment : 10mg for 14 days
1013360|NCT00784277|P3|Participant Flow|Tapentadol 75 mg|IR Treatment : 75mg for 14 days
1013361|NCT00784277|P2|Participant Flow|Tapentadol 50 mg|IR Treatment : 50mg for 14 days
1013362|NCT00784277|P1|Participant Flow|Placebo|IR Treatment : 1 capsule for 14 days
1013363|NCT00784277|O4|Outcome|Oxycodone|IR Treatment : 10mg capsule for 14 days
1013364|NCT00784277|O3|Outcome|Tapentadol 75 mg|IR Treatment : 75mg capsule for 14 days
1013365|NCT00784277|O2|Outcome|Tapentadol 50 mg|IR Treatment : 50mg capsule for 14 days
1013366|NCT00784277|O1|Outcome|Placebo|IR Treatment : 1 capsule for 14 days
1013367|NCT00784277|O4|Outcome|Oxycodone|IR Treatment : 10mg capsule for 14 days
1013368|NCT00784277|O3|Outcome|Tapentadol 75 mg|IR Treatment : 75mg capsule for 14 days
1013369|NCT00784277|O2|Outcome|Tapentadol 50 mg|IR Treatment : 50mg capsule for 14 days
1013370|NCT00784277|O1|Outcome|Placebo|IR Treatment : 1 capsule for 14 days
1013371|NCT00784277|E7|Reported Event|Oxycodone CR|ER Treatment : flexible dose tablets and capsules 2 x a day for 28 days (20-60mg/day)
1013372|NCT00784277|E6|Reported Event|Tapentadol ER|ER Treatment : flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day)
1013373|NCT00784277|E5|Reported Event|Placebo ER|ER Treatment : Tablets and capsules 2 x a day for 28 days
1013374|NCT00784277|E4|Reported Event|Oxycodone|IR Treatment : 10mg for 14 days
1013375|NCT00784277|E3|Reported Event|Tapentadol 75 mg|IR Treatment : 75mg for 14 days
1013376|NCT00784277|E2|Reported Event|Tapentadol 50 mg|IR Treatment : 50mg for 14 days
1013377|NCT00784277|E1|Reported Event|Placebo|IR Treatment : 1 capsule for 14 days
1013378|NCT00784238|B1|Baseline|Paliperidone|Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
1013379|NCT00784238|P1|Participant Flow|Paliperidone|Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
1013444|NCT00784095|P3|Participant Flow|True Control|"Subjects in the third group (true control) will be exposed to no intervention or attention control."
1013380|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
1013381|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
1013382|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
1013383|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
1013384|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
1013385|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
1013386|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
1013387|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
1013388|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
1013389|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
1013390|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
1013391|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
1013392|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
1013393|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
1013394|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
1013395|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
1013543|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1022412|NCT00762788|E6|Reported Event|Etafilcon A Contact Lens|ACUVUE 2
1013396|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
1013397|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
1013398|NCT00784238|O1|Outcome|Paliperidone|Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
1013399|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
1013400|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
1013401|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
1013402|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
1013403|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
1013404|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
1013405|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
1013406|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
1013407|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
1013408|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
1013409|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
1013410|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
1013411|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
1013445|NCT00784095|P2|Participant Flow|Attention Control|"The subjects in the second group (attention control) will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.~Attention Control: Subjects will listen to a non-guided relaxation CD."
1013544|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013412|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
1013413|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
1013414|NCT00784238|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
1013415|NCT00784238|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
1013416|NCT00784238|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
1013417|NCT00784238|O1|Outcome|Paliperidone|Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
1013418|NCT00784238|E1|Reported Event|Paliperidone|Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
1013419|NCT00784147|B3|Baseline|Total|Total of all reporting groups
1013420|NCT00784147|B2|Baseline|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
1013421|NCT00784147|B1|Baseline|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
1013422|NCT00784147|P2|Participant Flow|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
1013423|NCT00784147|P1|Participant Flow|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
1013424|NCT00784147|O2|Outcome|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
1013425|NCT00784147|O1|Outcome|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
1013426|NCT00784147|O2|Outcome|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
1013427|NCT00784147|O1|Outcome|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
1013428|NCT00784147|O2|Outcome|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
1013429|NCT00784147|O1|Outcome|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
1013430|NCT00784147|O2|Outcome|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
1013431|NCT00784147|O1|Outcome|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
1013432|NCT00784147|O2|Outcome|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
1013433|NCT00784147|O1|Outcome|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
1013434|NCT00784147|O2|Outcome|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
1013435|NCT00784147|O1|Outcome|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
1013436|NCT00784147|O2|Outcome|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
1013437|NCT00784147|O1|Outcome|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
1013438|NCT00784147|E2|Reported Event|Ibalizumab 2000 mg|"every 4 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 2000 mg IV every 4 weeks"
1013439|NCT00784147|E1|Reported Event|Ibalizumab 800 mg|"every 2 weeks, combined with an Optimized Background Regimen~Ibalizumab : Ibalizumab 800 mg IV every 2 weeks"
1013440|NCT00784095|B4|Baseline|Total|Total of all reporting groups
1013441|NCT00784095|B3|Baseline|True Control|"Subjects in the third group (true control) will be exposed to no intervention or attention control."
1013442|NCT00784095|B2|Baseline|Attention Control|"The subjects in the second group (attention control) will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.~Attention Control: Subjects will listen to a non-guided relaxation CD."
1013443|NCT00784095|B1|Baseline|Preparation and Completion|"Subjects in the first group (treatment)will meet with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy.~Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
1022413|NCT00762788|E5|Reported Event|Comfilcon A Contact Lens|Biofinity
1013446|NCT00784095|P1|Participant Flow|Preparation and Completion|"Subjects in the first group (treatment)will meet with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy.~Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
1013447|NCT00784095|O3|Outcome|True Control|"Subjects in the third group (true control) were exposed to no intervention or attention control."
1013448|NCT00784095|O2|Outcome|Attention Control|"The subjects in the second group (attention control) met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.~Attention Control: Subjects will listen to a non-guided relaxation CD."
1013449|NCT00784095|O1|Outcome|Preparation and Completion|"Subjects in the first group (treatment)met with the facilitator three times for a period of forty-five minutes to one hour to discuss issues of life completion and preparation. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects discussed issues of heritage and legacy.~Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
1013450|NCT00784095|O3|Outcome|True Control|"Subjects in the third group (true control) were exposed to no intervention or attention control."
1013451|NCT00784095|O2|Outcome|Attention Control|"The subjects in the second group (attention control) met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.~Attention Control: Subjects will listen to a non-guided relaxation CD."
1013452|NCT00784095|O1|Outcome|Preparation and Completion|"Subjects in the first group (treatment)met with the facilitator three times for a period of forty-five minutes to one hour to discuss issues of life completion and preparation. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects discussed issues of heritage and legacy.~Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
1013453|NCT00784095|O3|Outcome|True Control|"Subjects in the third group (true control) were exposed to no intervention or attention control."
1013454|NCT00784095|O2|Outcome|Attention Control|"The subjects in the second group (attention control) met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.~Attention Control: Subjects will listen to a non-guided relaxation CD."
1013455|NCT00784095|O1|Outcome|Preparation and Completion|"Subjects in the first group (treatment)met with the facilitator three times for a period of forty-five minutes to one hour to discuss issues of life completion and preparation. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects discussed issues of heritage and legacy.~Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
1013456|NCT00784095|O3|Outcome|True Control|"Subjects in the third group (true control) were exposed to no intervention or attention control."
1013457|NCT00784095|O2|Outcome|Attention Control|"The subjects in the second group (attention control) met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.~Attention Control: Subjects will listen to a non-guided relaxation CD."
1013458|NCT00784095|O1|Outcome|Preparation and Completion|"Subjects in the first group (treatment)met with the facilitator three times for a period of forty-five minutes to one hour to discuss issues of life completion and preparation. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects discussed issues of heritage and legacy.~Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
1013459|NCT00784095|O3|Outcome|True Control|"Subjects in the third group (true control) will be exposed to no intervention or attention control."
1013460|NCT00784095|O2|Outcome|Attention Control|"The subjects in the second group (attention control) will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.~Attention Control: Subjects will listen to a non-guided relaxation CD."
1013461|NCT00784095|O1|Outcome|Preparation and Completion|"Subjects in the first group (treatment)will meet with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy.~Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
1013462|NCT00784095|E3|Reported Event|True Control|"Subjects in the third group (true control) were exposed to no intervention or attention control."
1013463|NCT00784095|E2|Reported Event|Attention Control|"The subjects in the second group (attention control) met with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.~Attention Control: Subjects listened to a non-guided relaxation CD."
1013464|NCT00784095|E1|Reported Event|Preparation and Completion|"Subjects in the first group (treatment) met with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects focused on heritage and legacy.~Life completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
1013465|NCT00784030|B3|Baseline|Total|Total of all reporting groups
1013466|NCT00784030|B2|Baseline|Healthy Patients|
1013467|NCT00784030|B1|Baseline|Polycystic Kidney Disease (PKD) Patients|
1013468|NCT00784030|P2|Participant Flow|Healthy Patients|
1013469|NCT00784030|P1|Participant Flow|Polycystic Kidney Disease (PKD) Patients|Patients who present with polycystic kidney disease (PKD)
1013470|NCT00784030|O2|Outcome|Healthy Controls|Healthy Controls
1013471|NCT00784030|O1|Outcome|Polycystic Kidney Disease Patients|Patients with Autosomal Dominant Polycystic Kidney Disease
1013472|NCT00784030|E2|Reported Event|Healthy Controls|Healthy Controls
1013473|NCT00784030|E1|Reported Event|Polycystic Kidney Disease Patients|Patients with Autosomal Dominant Polycystic Kidney Disease
1013474|NCT00783965|B3|Baseline|Total|Total of all reporting groups
1013476|NCT00783965|B1|Baseline|Arm I|"Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on months 13-36 once daily to the chest.~placebo : Applied to the skin~tazarotene : Applied to the skin"
1013477|NCT00783965|P2|Participant Flow|Arm II|Vehicle (placebo) first, then 0.1% tazarotene cream
1013478|NCT00783965|P1|Participant Flow|Arm I|0.1% tazarotene cream first, then placebo
1013479|NCT00783965|O2|Outcome|Arm II|"Patients apply, vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on months 13-36 once daily to the chest.~placebo : Applied to the skin~tazarotene : Applied to the skin"
1013480|NCT00783965|O1|Outcome|Arm I|"Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on months 13-36 once daily to the chest.~placebo : Applied to the skin~tazarotene : Applied to the skin"
1013481|NCT00783965|O2|Outcome|Arm II|"Patients apply, vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on months 13-36 once daily to the chest.~placebo : Applied to the skin~tazarotene : Applied to the skin"
1013482|NCT00783965|O1|Outcome|Arm I|"Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on months 13-36 once daily to the chest.~placebo : Applied to the skin~tazarotene : Applied to the skin"
1013483|NCT00783965|E2|Reported Event|Arm II|"Patients apply, vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on months 13-36 once daily to the chest.~placebo : Applied to the skin~tazarotene : Applied to the skin"
1013484|NCT00783965|E1|Reported Event|Arm I|"Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on months 13-36 once daily to the chest.~placebo : Applied to the skin~tazarotene : Applied to the skin"
1013485|NCT00783952|B1|Baseline|Patients With Pulmonary Artery Catheters and Arterial Lines|"Patients with pulmonary artery catheters and arterial lines~'Cerebral/Somatic Tissue Oximeter' device: Measurement of tissue oxygen saturation and simultaneous sampling for blood gas analysis.~Four sensors of the 'Cerebral/Somatic Tissue Oximeter' device will be placed on subject's both sides of the forehead, palm and calf area. Simultaneously, blood samples will be drawn from the pulmonary artery catheter and arterial line for blood gas analyses. The values obtained from the device measurements will be used in a new equation to calculate the mixed venous oxygen saturation. The calculated value will be compared to the real value from the blood gas analysis for accuracy."
1013486|NCT00783952|P1|Participant Flow|Mixed Venous Oxygen and Calculation of Saturation|"Blood will be drawn form the pulmonary artery catheter for measurement of mixed venous oxygen saturation.Measurement of tissue oxygen saturation and simultaneous sampling for blood gas analysis.~Four sensors of the 'Cerebral/Somatic Tissue Oximeter' device will be placed on subject's both sides of the forehead, palm and calf area. Simultaneously, blood samples will be drawn from the pulmonary artery catheter and arterial line for blood gas analyses. The values obtained from the device measurements will be used in a new equation to calculate the mixed venous oxygen saturation. The calculated value will be compared to the real value from the blood gas analysis for accuracy."
1013487|NCT00783952|O2|Outcome|Patients With Cerebral/Somatic Tissue Oximeter Device|"Measurement of tissue oxygen saturation and simultaneous sampling for blood gas analysis.~Four sensors of the 'Cerebral/Somatic Tissue Oximeter' device will be placed on subject's both sides of the forehead, palm and calf area. Simultaneously, blood samples will be drawn from the pulmonary artery catheter and arterial line for blood gas analyses. The values obtained from the device measurements will be used in a new equation to calculate the mixed venous oxygen saturation. The calculated value will be compared to the real value from the blood gas analysis for accuracy."
1013488|NCT00783952|O1|Outcome|Patients With Pulmonary Artery Catheters and Arterial Lines|"Patients with pulmonary artery catheters and arterial lines~'Cerebral/Somatic Tissue Oximeter' device: Measurement of tissue oxygen saturation and simultaneous sampling for blood gas analysis.~Four sensors of the 'Cerebral/Somatic Tissue Oximeter' device will be placed on subject's both sides of the forehead, palm and calf area. Simultaneously, blood samples will be drawn from the pulmonary artery catheter and arterial line for blood gas analyses. The values obtained from the device measurements will be used in a new equation to calculate the mixed venous oxygen saturation. The calculated value will be compared to the real value from the blood gas analysis for accuracy."
1013489|NCT00783952|E1|Reported Event|Patients With Pulmonary Artery Catheters and Arterial Lines|"Patients with pulmonary artery catheters and arterial lines~'Cerebral/Somatic Tissue Oximeter' device: Measurement of tissue oxygen saturation and simultaneous sampling for blood gas analysis.~Four sensors of the 'Cerebral/Somatic Tissue Oximeter' device will be placed on subject's both sides of the forehead, palm and calf area. Simultaneously, blood samples will be drawn from the pulmonary artery catheter and arterial line for blood gas analyses. The values obtained from the device measurements will be used in a new equation to calculate the mixed venous oxygen saturation. The calculated value will be compared to the real value from the blood gas analysis for accuracy."
1013490|NCT00783835|B1|Baseline|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
1013491|NCT00783835|P1|Participant Flow|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
1013492|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
1013493|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
1013494|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
1013545|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013495|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
1013496|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
1013497|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
1013498|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
1013499|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
1013500|NCT00783835|O1|Outcome|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
1013501|NCT00783835|E1|Reported Event|Methylphenidate|Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician’s discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose.
1013502|NCT00783796|B1|Baseline|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013503|NCT00783796|P1|Participant Flow|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
1013504|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013505|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013506|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013507|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013508|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013509|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013510|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013511|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013512|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013513|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013514|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013515|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013516|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013517|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013518|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013519|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013520|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013521|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013522|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013523|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013524|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013525|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013526|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013527|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013528|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013529|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013530|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013531|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013532|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013533|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013534|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013535|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013536|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013537|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013538|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013539|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013540|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013541|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013542|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013549|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013550|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013551|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013552|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013553|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013554|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013555|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013556|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013557|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013558|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013559|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013560|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013561|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013562|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013563|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013564|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013565|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013566|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013567|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013568|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013569|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013570|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013571|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013572|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013573|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013574|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013575|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013576|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013577|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013578|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013579|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013580|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013581|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013582|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013583|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013584|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013585|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013586|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013587|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013588|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
1013589|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
1013590|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
1013591|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
1013592|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
1013593|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
1013594|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
1013595|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
1013596|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
1013597|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
1013598|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
1013599|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
1013600|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Based on Intent To Treat (ITT) population, defined as subjects enrolled in the study, regardless of the treatment actually received, and excluding de-registered subjects
1013601|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Based on Intent To Treat (ITT) population, defined as subjects enrolled in the study, regardless of the treatment actually received, and excluding de-registered subjects
1013602|NCT00783796|O1|Outcome|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013603|NCT00783796|E1|Reported Event|2.25mm XIENCE V®|Patients receiving the 2.25 mm XIENCE V® stent
1013604|NCT00783718|B4|Baseline|Total|Total of all reporting groups
1013605|NCT00783718|B3|Baseline|Induction Phase: OL Vedolizumab|In the Induction Phase participants in Cohort 2 received open-label vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
1013606|NCT00783718|B2|Baseline|Induction Phase: DB Vedolizumab|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
1013747|NCT00783302|P1|Participant Flow|Arm 1: Visipaque Injection x 320mgI/mL|Injection of Visipaque at a concentration of 320mg I /mL.
1013607|NCT00783718|B1|Baseline|Placebo|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind placebo intravenous infusions at Week 0 and Week 2. Participants continued to receive placebo every 4 weeks from Week 6 through Week 50 during the Maintenance Phase, regardless of treatment response during induction.
1013608|NCT00783718|P7|Participant Flow|Maintenance Phase: Non-responders|Participants who received vedolizumab during the Induction Phase who did not demonstrate a clinical response at Week 6 received open-label treatment with vedolizumab 300 mg every 4 weeks from Week 6 to Week 50.
1013609|NCT00783718|P6|Participant Flow|Maintenance Phase: Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
1013610|NCT00783718|P5|Participant Flow|Maintenance Phase: Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) at Weeks 6, 14, 22, 30, 38, and 46, and, to maintain blinding, placebo infusions at Weeks 10, 18, 26, 34, 42, and 50.
1013611|NCT00783718|P4|Participant Flow|Maintenance Phase: Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
1013612|NCT00783718|P3|Participant Flow|Induction Phase: OL Vedolizumab|In the Induction Phase participants in Cohort 2 received open-label (OL) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
1013613|NCT00783718|P2|Participant Flow|Induction Phase: DB Vedolizumab|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind (DB) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
1013614|NCT00783718|P1|Participant Flow|Placebo|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind placebo intravenous infusions at Week 0 and Week 2. Participants continued to receive placebo every 4 weeks from Week 6 through Week 50 during the Maintenance Phase, regardless of treatment response during induction.
1013615|NCT00783718|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
1013616|NCT00783718|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
1013617|NCT00783718|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
1013618|NCT00783718|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
1013619|NCT00783718|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
1013620|NCT00783718|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
1013621|NCT00783718|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
1013622|NCT00783718|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
1013623|NCT00783718|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
1013624|NCT00783718|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
1013625|NCT00783718|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
1013626|NCT00783718|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
1013627|NCT00783718|O2|Outcome|DB Vedolizumab|Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
1013628|NCT00783718|O1|Outcome|Placebo|Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
1013629|NCT00783718|O2|Outcome|DB Vedolizumab|Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
1013630|NCT00783718|O1|Outcome|Placebo|Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
1013631|NCT00783718|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
1013632|NCT00783718|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
1013633|NCT00783718|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
1013634|NCT00783718|O2|Outcome|DB Vedolizumab|Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
1013635|NCT00783718|O1|Outcome|Placebo|Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
1013636|NCT00783718|E3|Reported Event|Vedolizumab|Participants who received vedolizumab during the Induction Phase and continued to receive vedolizumab during the Maintenance Phase. This includes participants who had a clinical response at Week 6 and were randomized to vedolizumab every 4 weeks or every 8 weeks in the Maintenance Phase, participants who did not achieve a clinical response at Week 6 and continued to receive vedolizumab every 4 weeks for the duration of the study, and participants who withdrew during the Induction phase.
1013637|NCT00783718|E2|Reported Event|Vedolizumab Then Placebo|Participants who received vedolizumab during the Induction Phase and were then randomized to receive placebo during the Maintenance Phase.
1013638|NCT00783718|E1|Reported Event|Placebo|Participants who received double-blind placebo intravenous infusions in the Induction Phase and continued to receive placebo during the Maintenance Phase.
1013639|NCT00783705|B3|Baseline|Total|Total of all reporting groups
1013640|NCT00783705|B2|Baseline|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013641|NCT00783705|B1|Baseline|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013642|NCT00783705|P2|Participant Flow|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013643|NCT00783705|P1|Participant Flow|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013644|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013645|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013646|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013647|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013648|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013649|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013650|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013651|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013652|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013653|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013654|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013655|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013656|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013657|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013658|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013659|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013660|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013661|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013662|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013663|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013664|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013665|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013666|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013667|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013668|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013669|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1022414|NCT00762788|E4|Reported Event|Balafilcon A Contact Lens|PureVision
1013670|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013671|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013672|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013673|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013674|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013675|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013676|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013677|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013678|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013679|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013680|NCT00783705|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013681|NCT00783705|O1|Outcome|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013682|NCT00783705|E2|Reported Event|Arm B (Placebo)|Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013683|NCT00783705|E1|Reported Event|Arm A (Myo-inositol)|Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
1013684|NCT00783692|B4|Baseline|Total|Total of all reporting groups
1013685|NCT00783692|B3|Baseline|Induction Phase: OL Vedolizumab|In the Induction Phase participants in Cohort 2 received open-label (OL) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
1013686|NCT00783692|B2|Baseline|Induction Phase: DB Vedolizumab|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind (DB) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
1013687|NCT00783692|B1|Baseline|Placebo|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind placebo intravenous infusions at Week 0 and Week 2.
1013688|NCT00783692|P7|Participant Flow|Maintenance Phase: Non-Responders|Participants who received vedolizumab during the Induction Phase who did not demonstrate a clinical response at Week 6 received open-label treatment with vedolizumab 300 mg every 4 weeks from Week 6 to Week 50.
1013689|NCT00783692|P6|Participant Flow|Maintenance Phase: Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
1013690|NCT00783692|P5|Participant Flow|Maintenance Phase: Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) at Weeks 6, 14, 22, 30, 38, and 46, and, to maintain blinding, placebo infusions at Weeks 10, 18, 26, 34, 42, and 50.
1013691|NCT00783692|P4|Participant Flow|Maintenance Phase: Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
1013692|NCT00783692|P3|Participant Flow|Induction Phase: OL Vedolizumab|In the Induction Phase participants in Cohort 2 received open-label (OL) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
1013693|NCT00783692|P2|Participant Flow|Induction Phase: DB Vedolizumab|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind (DB) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.
1013694|NCT00783692|P1|Participant Flow|Placebo|In the Induction Phase participants in Cohort 1 were randomized to receive double-blind placebo intravenous infusions at Week 0 and Week 2. Participants continued to receive placebo every 4 weeks from Week 6 through Week 50 during the Maintenance Phase, regardless of treatment response during induction.
1013695|NCT00783692|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
1013696|NCT00783692|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
1013697|NCT00783692|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
1013698|NCT00783692|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
1013699|NCT00783692|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
1013700|NCT00783692|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
1014183|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1013701|NCT00783692|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
1013702|NCT00783692|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
1013703|NCT00783692|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
1013704|NCT00783692|O2|Outcome|DB Vedolizumab|Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
1013705|NCT00783692|O1|Outcome|Placebo|Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
1013706|NCT00783692|O3|Outcome|Vedolizumab Q4W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.
1013707|NCT00783692|O2|Outcome|Vedolizumab Q8W|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.
1013708|NCT00783692|O1|Outcome|Placebo|Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.
1013709|NCT00783692|O2|Outcome|DB Vedolizumab|Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
1013710|NCT00783692|O1|Outcome|Placebo|Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
1013711|NCT00783692|O2|Outcome|DB Vedolizumab|Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.
1013712|NCT00783692|O1|Outcome|Placebo|Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.
1013713|NCT00783692|E3|Reported Event|VDZ/VDZ|Participants who received vedolizumab during the Induction Phase and continued to receive vedolizumab during the Maintenance Phase. This includes participants who had a clinical response at Week 6 and were randomized to vedolizumab every 4 weeks or every 8 weeks in the Maintenance Phase, participants who did not achieve a clinical response at Week 6 and continued to receive vedolizumab every 4 weeks for the duration of the study, and participants who withdrew during the Induction phase.
1013714|NCT00783692|E2|Reported Event|VDZ/PBO|Participants who received vedolizumab during the Induction Phase and were then randomized to receive placebo during the Maintenance Phase.
1013715|NCT00783692|E1|Reported Event|Placebo|Participants who received double-blind placebo intravenous infusions in the Induction Phase and continued to receive placebo during the Maintenance Phase.
1013716|NCT00783614|B5|Baseline|Total|Total of all reporting groups
1013717|NCT00783614|B4|Baseline|Defer and Placebo|Defer ART for 1 month and immediately initiate placebo pill daily
1013718|NCT00783614|B3|Baseline|Defer and Aspirin|Defer ART for 1 month and immediately initiate aspirin 325mg po daily
1013719|NCT00783614|B2|Baseline|ART and Placebo|Start ART immediately and initiate placebo pill daily
1013720|NCT00783614|B1|Baseline|ART and Aspirin|Start ART immediately and initiate aspirin 325mg po daily
1013721|NCT00783614|P4|Participant Flow|Defer and Placebo|Defer ART for 1 month and immediately initiate placebo pill daily
1013722|NCT00783614|P3|Participant Flow|Defer and Aspirin|Defer ART for 1 month and immediately initiate aspirin 325mg po daily
1013723|NCT00783614|P2|Participant Flow|ART and Placebo|Start ART immediately and initiate placebo pill daily
1013724|NCT00783614|P1|Participant Flow|ART and Aspirin|Start ART immediately and initiate aspirin 325mg po daily
1013725|NCT00783614|O4|Outcome|Defer and Placebo|Defer ART for 1 month and immediately initiate placebo pill daily
1013726|NCT00783614|O3|Outcome|Defer and Aspirin|Defer ART for 1 month and immediately initiate aspirin 325mg po daily
1013727|NCT00783614|O2|Outcome|ART and Placebo|Start ART immediately and initiate placebo pill daily
1013728|NCT00783614|O1|Outcome|ART and Aspirin|Start ART immediately and initiate aspirin 325mg po daily
1013729|NCT00783614|E4|Reported Event|Defer and Placebo|Defer ART for 1 month and immediately initiate placebo pill daily
1013730|NCT00783614|E3|Reported Event|Defer and Aspirin|Defer ART for 1 month and immediately initiate aspirin 325mg po daily
1013731|NCT00783614|E2|Reported Event|ART and Placebo|Start ART immediately and initiate placebo pill daily
1013732|NCT00783614|E1|Reported Event|ART and Aspirin|Start ART immediately and initiate aspirin 325mg po daily
1013733|NCT00783432|B3|Baseline|Total|Total of all reporting groups
1013734|NCT00783432|B2|Baseline|Astelin Nasal Spray|(0.1% azelastine hydrochloride)
1013735|NCT00783432|B1|Baseline|Astepro Nasal Spray|(0.1% azelastine hydrochloride)
1013736|NCT00783432|P2|Participant Flow|Astelin Nasal Spray|(0.1% azelastine hydrochloride)
1013737|NCT00783432|P1|Participant Flow|Astepro Nasal Spray|(0.1% azelastine hydrochloride)
1013738|NCT00783432|O2|Outcome|Astelin Nasal Spray|(0.1% azelastine hydrochloride)
1013739|NCT00783432|O1|Outcome|Astepro Nasal Spray|(0.1% azelastine hydrochloride)
1013740|NCT00783432|O2|Outcome|Astelin Nasal Spray|(0.1% azelastine hydrochloride)
1013741|NCT00783432|O1|Outcome|Astepro Nasal Spray|(0.1% azelastine hydrochloride)
1013742|NCT00783432|O2|Outcome|Astelin Nasal Spray|(0.1% azelastine hydrochloride)
1013743|NCT00783432|O1|Outcome|Astepro Nasal Spray|(0.1% azelastine hydrochloride)
1013744|NCT00783432|E2|Reported Event|Astelin Nasal Spray|(0.1% azelastine hydrochloride)
1013745|NCT00783432|E1|Reported Event|Astepro Nasal Spray|(0.1% azelastine hydrochloride)
1013746|NCT00783302|B1|Baseline|Arm 1: Visipaque Injection x 320mgI/mL|Injection of Visipaque at a concentration of 320mg I /mL.
1013748|NCT00783302|O3|Outcome|Follow-up Period at 12 Months|Summary of Patient-Level Clinical Outcomes by Follow-up Period (Efficacy Population) for 12 months.
1013749|NCT00783302|O2|Outcome|Follow-up Period at 6 Months|Summary of Patient-Level Clinical Outcomes by Follow-up Period (Efficacy Population) for 6 months.
1013750|NCT00783302|O1|Outcome|Follow-up Period at 1 Month|Summary of Patient-Level Clinical Outcomes by Follow-up Period (Efficacy Population) for 1 month.
1013751|NCT00783302|O3|Outcome|Negative Predictive Value - Subject Follow-up Period 12 Months|Number of Subjects True Negative by Coronary Computed Tomography Angiography (CCTA) / # Subjects Negative by Coronary Computed Tomography Angiography (CCTA)
1013752|NCT00783302|O2|Outcome|Negative Predictive Value - Subject Follow-up Period 6 Months|Number of Subjects True Negative by Coronary Computed Tomography Angiography (CCTA) / # Subjects Negative by Coronary Computed Tomography Angiography (CCTA)
1013753|NCT00783302|O1|Outcome|Negative Predictive Value - Subject Follow-up Period 1 Month|Number of Subjects True Negative by Coronary Computed Tomography Angiography (CCTA) / # Subjects Negative by Coronary Computed Tomography Angiography (CCTA)
1013754|NCT00783302|O3|Outcome|Specificity - Subject Follow-up Period 12 Months|Number of Subjects Negative by Coronary Computed Tomography Angiography (CCTA) & Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
1013755|NCT00783302|O2|Outcome|Specificity - Subject Follow-up Period 6 Months|Number of Subjects Negative by Coronary Computed Tomography Angiography (CCTA) & Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
1013756|NCT00783302|O1|Outcome|Specificity - Subject Follow-up Period 1 Month|Number of Subjects Negative by Coronary Computed Tomography Angiography (CCTA) & Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
1013757|NCT00783302|O3|Outcome|Positive Predictive Value - Subject Follow-up Period 12 Months|Number of Subjects True Positive by Coronary Computed Tomography Angiography (CCTA) / # Subjects Positive by Coronary Computed Tomography Angiography (CCTA)
1013758|NCT00783302|O2|Outcome|Positive Predictive Value - Subject Follow-up Period 6 Months|Number of Subjects True Positive by Coronary Computed Tomography Angiography (CCTA) / # Subjects Positive by Coronary Computed Tomography Angiography (CCTA)
1013759|NCT00783302|O1|Outcome|Positive Predictive Value - Subject Follow-up Period 1 Month|Number of Subjects True Positive by Coronary Computed Tomography Angiography (CCTA) / # Subjects Positive by Coronary Computed Tomography Angiography (CCTA)
1013760|NCT00783302|O3|Outcome|Sensitivity - Subject Follow-up Period 12 Months|Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) & Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
1013761|NCT00783302|O2|Outcome|Sensitivity - Subject Follow-up Period 6 Months|Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) & Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
1013762|NCT00783302|O1|Outcome|Sensitivity - Subject Follow-up Period 1 Month|Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) & Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).
1013763|NCT00783302|E1|Reported Event|Arm 1: Visipaque Injection x 320mgI/mL|Injection of Visipaque at a concentration of 320mg I /mL.
1013764|NCT00783263|B5|Baseline|Total|Total of all reporting groups
1013765|NCT00783263|B4|Baseline|Rosuvastatin 20 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
1013766|NCT00783263|B3|Baseline|Rosuvastatin 10 mg + Ezetimibe 10 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
1013767|NCT00783263|B2|Baseline|Rosuvastatin 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
1013768|NCT00783263|B1|Baseline|Rosuvastatin 5 mg + Ezetimibe 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
1013769|NCT00783263|P4|Participant Flow|Rosuvastatin 20 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
1013770|NCT00783263|P3|Participant Flow|Rosuvastatin 10 mg + Ezetimibe 10 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
1013771|NCT00783263|P2|Participant Flow|Rosuvastatin 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
1013772|NCT00783263|P1|Participant Flow|Rosuvastatin 5 mg + Ezetimibe 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
1013773|NCT00783263|O2|Outcome|Rosuvastatin 10 or 20 mg|Participants who received rosuvastatin (5 or 10 mg) tablets once daily for 4 to 5 weeks then received rosuvastatin (10 or 20 mg) once daily for 6 additional weeks.
1013774|NCT00783263|O1|Outcome|Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mg|Participants who received open label rosuvastatin 5 or 10 mg tablets once daily for 4 to 5 weeks then received 10 or 20 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
1013775|NCT00783263|O4|Outcome|Rosuvastatin 20 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
1013776|NCT00783263|O3|Outcome|Rosuvastatin 10 mg + Ezetimibe 10 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
1013777|NCT00783263|O2|Outcome|Rosuvastatin 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
1013778|NCT00783263|O1|Outcome|Rosuvastatin 5 mg + Ezetimibe 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
1013848|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
1013779|NCT00783263|O2|Outcome|Rosuvastatin 10 or 20 mg|Participants who received rosuvastatin (5 or 10 mg) tablets once daily for 4 to 5 weeks then received rosuvastatin (10 or 20 mg) once daily for 6 additional weeks.
1013780|NCT00783263|O1|Outcome|Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mg|Participants who received open label rosuvastatin 5 or 10 mg tablets once daily for 4 to 5 weeks then received 10 or 20 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
1013781|NCT00783263|O4|Outcome|Rosuvastatin 20 mg (Stratum II)|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
1013782|NCT00783263|O3|Outcome|Rosuvastatin 10 mg + Ezetimibe 10 mg (Stratum II)|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
1013783|NCT00783263|O2|Outcome|Rosuvastatin 10 mg (Stratum I)|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
1013784|NCT00783263|O1|Outcome|Rosuvastatin 5 mg + Ezetimibe 10 mg (Stratum I)|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
1013785|NCT00783263|O2|Outcome|Rosuvastatin (10 or 20 mg)|Participants who received rosuvastatin (5 or 10 mg) mg tablets once daily for 4 to 5 weeks then received rosuvastatin (10 or 20 mg) once daily for 6 additional weeks.
1013786|NCT00783263|O1|Outcome|Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
1013787|NCT00783263|O4|Outcome|Rosuvastatin 20 mg (Stratum II)|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
1013788|NCT00783263|O3|Outcome|Rosuvastatin 10 mg + Ezetimibe 10 mg (Stratum II)|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
1013789|NCT00783263|O2|Outcome|Rosuvastatin 10 mg (Stratum I)|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
1013790|NCT00783263|O1|Outcome|Rosuvastatin 5 mg + Ezetimibe 10 mg (Stratum I)|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
1013791|NCT00783263|O2|Outcome|Rosuvastatin (10 or 20 mg)|Participants who received open label rosuvastatin (5 or 10 mg) tablets once daily for 4 to 5 weeks then received rosuvastatin (10 or 20 mg) once daily for 6 additional weeks.
1013792|NCT00783263|O1|Outcome|Rosuvastatin (5 or 10 mg) + Ezetimibe 10 mg|Participants who received open label rosuvastatin (5 or 10 mg) tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus (5 or 10 mg) rosuvastatin for an additional 6 weeks.
1013793|NCT00783263|E4|Reported Event|Rosuva 20 mg|Participants who received rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
1013794|NCT00783263|E3|Reported Event|Rosuva 10 mg + EZ 10 mg|Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
1013795|NCT00783263|E2|Reported Event|Rosuva 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
1013796|NCT00783263|E1|Reported Event|Rosuva 5 mg + EZ 10 mg|Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5mg rosuvastatin for an additional 6 weeks.
1013797|NCT00783224|B5|Baseline|Total|Total of all reporting groups
1013798|NCT00783224|B4|Baseline|Fluticasone Propionate (FP)|Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)
1013799|NCT00783224|B3|Baseline|Mometasone Furoate (MF)|Mometasone furoate nasal spray 200 μg/day(QD)
1013800|NCT00783224|B2|Baseline|Fluticasone Propionate Placebo (PLAFP)|Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray
1013801|NCT00783224|B1|Baseline|Mometasone Furoate Placebo (PLAMF)|Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray
1013802|NCT00783224|P4|Participant Flow|Fluticasone Propionate (FP)|Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)
1013803|NCT00783224|P3|Participant Flow|Mometasone Furoate (MF)|Mometasone furoate nasal spray 200 μg/day(QD)
1013804|NCT00783224|P2|Participant Flow|Fluticasone Propionate Placebo (PLAFP)|Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray
1013805|NCT00783224|P1|Participant Flow|Mometasone Furoate Placebo (PLAMF)|Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray
1013806|NCT00783224|O4|Outcome|Fluticasone Propionate (FP)|Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)
1013807|NCT00783224|O3|Outcome|Mometasone Furoate (MF)|Mometasone furoate nasal spray 200 μg/day(QD)
1013808|NCT00783224|O2|Outcome|Fluticasone Propionate Placebo (PLAFP)|Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray
1013809|NCT00783224|O1|Outcome|Mometasone Furoate Placebo (PLAMF)|Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray
1013810|NCT00783224|E3|Reported Event|Fluticasone Propionate (FP)|Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)
1013811|NCT00783224|E2|Reported Event|Mometasone Furoate (MF)|Mometasone furoate nasal spray 200 μg/day(QD)
1013812|NCT00783224|E1|Reported Event|Mometasone Furoate Placebo and Fluticasone Propionate Placebo|Both placebo groups (arms) were combined to report adverse events
1013813|NCT00783198|B4|Baseline|Total|Total of all reporting groups
1013814|NCT00783198|B3|Baseline|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
1015194|NCT00779025|O1|Outcome|MINE Alone|Female Personal Lubricant (PD-F-5254)
1013815|NCT00783198|B2|Baseline|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
1013816|NCT00783198|B1|Baseline|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
1013817|NCT00783198|P3|Participant Flow|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
1013818|NCT00783198|P2|Participant Flow|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
1013819|NCT00783198|P1|Participant Flow|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
1013820|NCT00783198|O3|Outcome|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
1013821|NCT00783198|O2|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
1013822|NCT00783198|O1|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
1013823|NCT00783198|O3|Outcome|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
1013824|NCT00783198|O2|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
1013825|NCT00783198|O1|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
1013826|NCT00783198|O3|Outcome|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
1013827|NCT00783198|O2|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
1013828|NCT00783198|O1|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
1013829|NCT00783198|O3|Outcome|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
1013830|NCT00783198|O2|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
1013831|NCT00783198|O1|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
1013832|NCT00783198|O3|Outcome|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
1013833|NCT00783198|O2|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
1013834|NCT00783198|O1|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
1013835|NCT00783198|E3|Reported Event|Placebo|Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
1013836|NCT00783198|E2|Reported Event|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
1013837|NCT00783198|E1|Reported Event|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
1013838|NCT00783094|B4|Baseline|Total|Total of all reporting groups
1013839|NCT00783094|B3|Baseline|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
1013840|NCT00783094|B2|Baseline|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013841|NCT00783094|B1|Baseline|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013842|NCT00783094|P3|Participant Flow|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
1013843|NCT00783094|P2|Participant Flow|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013844|NCT00783094|P1|Participant Flow|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013845|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
1013846|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013847|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1015195|NCT00779025|E1|Reported Event|Overall Study|
1013849|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013850|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013851|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
1013852|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013853|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013854|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
1013855|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013856|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013857|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
1013858|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013859|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013860|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
1013861|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013862|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013863|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
1013864|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013865|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013866|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
1013867|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013868|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013869|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
1013870|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013871|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013872|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
1013873|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013874|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013875|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
1013876|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013877|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013878|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
1013879|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013880|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013881|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
1013882|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013883|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013884|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
1013885|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013886|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013887|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
1015196|NCT00778999|B3|Baseline|Total|Total of all reporting groups
1013888|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013889|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013890|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
1013891|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013892|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013893|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013894|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013895|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
1013896|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013897|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013898|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
1013899|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013900|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013901|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
1013902|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013903|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013904|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
1013905|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013906|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013907|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
1013908|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013909|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013910|NCT00783094|O3|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks."
1013911|NCT00783094|O2|Outcome|Tadalafil 5 mg|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013912|NCT00783094|O1|Outcome|Tadalafil 2.5 mg|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
1013913|NCT00783094|E6|Reported Event|Placebo: Tadalafil 5 mg Open-Label|5 mg tadalafil tablet by mouth once a day for 42 weeks. Participants had previously received placebo in the double-blind phase.
1013914|NCT00783094|E5|Reported Event|Tadalafil 5 mg: Tadalafil 5 mg Open-Label|5 mg tadalafil tablet by mouth once a day for 42 weeks. Participants had previously received 5 mg tadalafil in the double-blind phase.
1013915|NCT00783094|E4|Reported Event|Tadalafil 2.5 mg: Tadalafil 5 mg Open-Label|5 mg tadalafil tablet by mouth once a day for 42 weeks. Participants had previously received 2.5 mg tadalafil in the double-blind phase.
1013916|NCT00783094|E3|Reported Event|Placebo - Double-Blind Phase|"Placebo tablet taken by mouth once a day for 12 weeks.~Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks during the Open-Label Phase."
1013917|NCT00783094|E2|Reported Event|Tadalafil 5 mg - Double-Blind Phase|5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks during the Open-Label Phase.
1013918|NCT00783094|E1|Reported Event|Tadalafil 2.5 mg - Double-Blind Phase|2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks in the Open-Label Phase.
1013919|NCT00782834|B1|Baseline|Nilotinib Arm|All patients treated with nilotinib 400 mg BID orally daily; 4 weeks = one cycle
1013920|NCT00782834|P1|Participant Flow|Nilotinib Arm|All patients treated with nilotinib 400 mg BID orally daily; 4 weeks = one cycle
1013921|NCT00782834|O1|Outcome|Nilotinib Arm|All patients treated with nilotinib 400 mg BID orally daily; 4 weeks = one cycle
1013922|NCT00782834|O1|Outcome|Nilotinib Arm|All patients treated with nilotinib 400 mg BID orally daily; 4 weeks = one cycle
1013923|NCT00782834|E1|Reported Event|Nilotinib Arm|All patients treated with nilotinib 400 mg BID orally daily; 4 weeks = one cycle
1013924|NCT00782821|B5|Baseline|Total|Total of all reporting groups
1013954|NCT00782821|E3|Reported Event|RATG/Velcade|"Rabbit Antithymocyte Globulin (RATG) /Velcade~RATG/Rituxan/Velcade: Rabbit Antithymocyte Globulin (RATG)/ Rituxan/ Velcade"
1013955|NCT00782821|E2|Reported Event|RATG/Rituxan|"Rabbit Antithymocyte Globulin (RATG)/Rituxan~RATG/Rituxan: RATG/Rituxan~RATG/Rituxan/Velcade: Rabbit Antithymocyte Globulin (RATG)/ Rituxan/ Velcade"
1015757|NCT00777179|O1|Outcome|Vandetanib|Vandetanib 300 mg, orally, once daily
1013925|NCT00782821|B4|Baseline|RATG/Rituxan/Velcade|"Thymoglobulin x 4 doses (1.5mg/kg IV)+ Rituximab 200mg/m2 IV + Velcade (1.3 mg/m2 IVP)~Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily)."
1013926|NCT00782821|B3|Baseline|RATG/Velcade|"Thymoglobulin (RATG) x 5 doses (1.5mg/kg IV) + Velcade (1.3 mg/m2 IVP)~Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily)."
1013927|NCT00782821|B2|Baseline|RATG/Rituxan|"Thymoglobulin (RATG) x 5 doses (1.5mg/kg IV)+ Rituximab 375mg/m2 IV~Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily)."
1013928|NCT00782821|B1|Baseline|Rabbit Antithymocyte Globulin (RATG)|Thymoglobulin (RATG) x 6 doses (1.5mg/kg IV) Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily).
1013929|NCT00782821|P4|Participant Flow|RATG/Rituxan/Velcade|Thymoglobulin x 4 doses (1.5mg/kg IV). + Rituximab 200mg/m2 IV + Bortezomib 1.3 mg/m2 IVP Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily). Patients randomized to Arm C or D will receive 1.3 mg/m2 via IVP over 3-5 minutes on POD 0, 3, 7 and 10. The dose administered on POD 0 will be administered before pre-operatively before the pre-operative dose of methylprednisolone.
1013930|NCT00782821|P3|Participant Flow|RATG/Velcade|"Thymoglobulin x 5 doses (1.5mg/kg IV) + Velcade (1.3 mg/m2 IVP)~Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily). Patients randomized to Arm C or D will receive 1.3 mg/m2 via IVP over 3-5 minutes on POD 0, 3, 7 and 10. The dose administered on POD 0 will be administered before pre-operatively before the pre-operative dose of methylprednisolone."
1013931|NCT00782821|P2|Participant Flow|RATG/Rituxan|"Thymoglobulin x 5 doses (1.5mg/kg IV) + Rituximab 375mg/m2 IV~Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily)."
1013932|NCT00782821|P1|Participant Flow|Rabbit Antithymocyte Globulin (rATG)|"Thymoglobulin x 6 doses (1.5mg/kg IV).~Thymoglobulin is to be given on post operative days (POD) 0, 2, 4, 6 in all patients. Patients who receive a 5th dose will be administered a dose of Thymoglobulin on POD 8 and those who receive a 6th dose will be administered Thymoglobulin on POD 10. All groups will receive maintenance immunosuppression consisting of tacrolimus, mycophenolate mofetil, and corticosteroids (7 day corticosteroid taper to prednisone 5 mg daily)."
1013933|NCT00782821|O4|Outcome|RATG/Rituxan/Velcade|"Rabbit Antithymocyte Globulin (RATG) / Rituxan / Velcade~RATG/Velcade: RATG/Velcade"
1013934|NCT00782821|O3|Outcome|RATG/Velcade|"Rabbit Antithymocyte Globulin (RATG) /Velcade~RATG/Rituxan/Velcade: Rabbit Antithymocyte Globulin (RATG)/ Rituxan/ Velcade"
1013935|NCT00782821|O2|Outcome|RATG/Rituxan|"Rabbit Antithymocyte Globulin (RATG)/Rituxan~RATG/Rituxan: RATG/Rituxan~RATG/Rituxan/Velcade: Rabbit Antithymocyte Globulin (RATG)/ Rituxan/ Velcade"
1013936|NCT00782821|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|"Rabbit Antithymocyte Globulin (RATG)~Rabbit Antithymocyte Globulin (RATG): RATG"
1013937|NCT00782821|O4|Outcome|RATG/Rituxan/Velcade|Thymoglobulin x 4 doses + Rituximab 200mg/m2 + Bortezomib
1013938|NCT00782821|O3|Outcome|RATG/Velcade|Thymoglobulin x 5 doses + Velcade
1013939|NCT00782821|O2|Outcome|RATG/Rituxan|Thymoglobulin x 5 doses + Rituximab 375mg/m2
1013940|NCT00782821|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|Thymoglobulin (RATG) x 6 doses (1.5mg/kg IV)
1013941|NCT00782821|O4|Outcome|RATG/Rituxan/Velcade|Thymoglobulin x 4 doses + Rituximab 200mg/m2 + Bortezomib
1013942|NCT00782821|O3|Outcome|RATG/Velcade|Thymoglobulin x 5 doses + Bortezomib
1013943|NCT00782821|O2|Outcome|RATG/Rituxan|Thymoglobulin x 5 doses + Rituximab 375mg/m2
1013944|NCT00782821|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|Thymoglobulin x 6 doses
1013945|NCT00782821|O4|Outcome|RATG/Rituxan/Velcade|Thymoglobulin x 4 doses + Rituximab 200mg/m2 + Velcade
1013946|NCT00782821|O3|Outcome|RATG/Velcade|Thymoglobulin x 5 doses + Velcade
1013947|NCT00782821|O2|Outcome|RATG/Rituxan|Thymoglobulin x 5 doses + Rituximab 375mg/m2
1013948|NCT00782821|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|Thymoglobulin x 6 doses
1013949|NCT00782821|O4|Outcome|RATG/Rituxan/Velcade|Thymoglobulin x 4 doses + Rituximab 200mg/m2 + Velcade
1013950|NCT00782821|O3|Outcome|RATG/Velcade|Thymoglobulin x 5 doses + Velcade
1013951|NCT00782821|O2|Outcome|RATG/Rituxan|Thymoglobulin x 5 doses + Rituximab 375mg/m2
1013952|NCT00782821|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|Thymoglobulin x 6 doses
1013953|NCT00782821|E4|Reported Event|RATG/Rituxan/Velcade|"Rabbit Antithymocyte Globulin (RATG) / Rituxan / Velcade~RATG/Velcade: RATG/Velcade"
1014004|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
1013956|NCT00782821|E1|Reported Event|Rabbit Antithymocyte Globulin (RATG)|"Rabbit Antithymocyte Globulin (RATG)~Rabbit Antithymocyte Globulin (RATG): RATG"
1013957|NCT00782717|B3|Baseline|Total|Total of all reporting groups
1013958|NCT00782717|B2|Baseline|Nepafenac Vehicle|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
1013959|NCT00782717|B1|Baseline|NEVANAC|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
1013960|NCT00782717|P2|Participant Flow|Nepafenac Vehicle|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
1013961|NCT00782717|P1|Participant Flow|NEVANAC|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
1013962|NCT00782717|O2|Outcome|Nepafenac Vehicle|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
1013963|NCT00782717|O1|Outcome|NEVANAC|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
1013964|NCT00782717|O2|Outcome|Nepafenac Vehicle|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
1013965|NCT00782717|O1|Outcome|NEVANAC|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
1013966|NCT00782717|E2|Reported Event|Nepafenac Vehicle|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
1013967|NCT00782717|E1|Reported Event|NEVANAC|One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
1013968|NCT00782639|B3|Baseline|Total|Total of all reporting groups
1013969|NCT00782639|B2|Baseline|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
1013970|NCT00782639|B1|Baseline|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
1013971|NCT00782639|P2|Participant Flow|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
1013972|NCT00782639|P1|Participant Flow|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
1013973|NCT00782639|O2|Outcome|Visipaque 320|(Iodixanol injection at the 320 milligrams of iodine per milliliter [mgI/mL] concentration)
1013974|NCT00782639|O1|Outcome|Iopamiro-370|(Iopamidol injection at the 370 milligrams of iodine per milliliter [mgI/mL] concentration)
1013975|NCT00782639|O2|Outcome|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
1013976|NCT00782639|O1|Outcome|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
1013977|NCT00782639|O2|Outcome|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
1013978|NCT00782639|O1|Outcome|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
1013979|NCT00782639|O2|Outcome|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
1013980|NCT00782639|O1|Outcome|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
1013981|NCT00782639|O2|Outcome|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
1013982|NCT00782639|O1|Outcome|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
1013983|NCT00782639|O2|Outcome|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
1013984|NCT00782639|O1|Outcome|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
1013985|NCT00782639|E2|Reported Event|Visipaque 320|(Iodixanol injection at the 320 mgI/mL concentration)
1013986|NCT00782639|E1|Reported Event|Iopamiro-370|(Iopamidol injection at the 370 mgI/mL concentration)
1013987|NCT00782626|B1|Baseline|Everolimus|Patients rcvd oral everolimus 5.0 mg/m2/day for a 28-day treatment course up to a total of 12 courses (48 weeks) if a patient had stable disease except if toxicity was unacceptable. Two dose reductions were permitted (3.0 5.0 mg/m2/day and 2.0 mg/m2/day).
1013988|NCT00782626|P1|Participant Flow|Everolimus|Patients rcvd oral everolimus 5.0 mg/m2/day for a 28-day treatment course up to a total of 12 courses (48 weeks) if a patient had stable disease except if toxicity was unacceptable. Two dose reductions were permitted (3.0 5.0 mg/m2/day and 2.0 mg/m2/day).
1013989|NCT00782626|O1|Outcome|Everolimus|Patients rcvd oral everolimus 5.0 mg/m2/day for a 28-day treatment course up to a total of 12 courses (48 weeks) if a patient had stable disease except if toxicity was unacceptable. Two dose reductions were permitted (3.0 5.0 mg/m2/day and 2.0 mg/m2/day).
1013990|NCT00782626|E1|Reported Event|Everolimus|Patients rcvd oral everolimus 5.0 mg/m2/day for a 28-day treatment course up to a total of 12 courses (48 weeks) if a patient had stable disease except if toxicity was unacceptable. Two dose reductions were permitted (3.0 5.0 mg/m2/day and 2.0 mg/m2/day).
1013991|NCT00782509|B4|Baseline|Total|Total of all reporting groups
1013992|NCT00782509|B3|Baseline|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1013993|NCT00782509|B2|Baseline|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1013994|NCT00782509|B1|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1013995|NCT00782509|P3|Participant Flow|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1013996|NCT00782509|P2|Participant Flow|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1013997|NCT00782509|P1|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1013998|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
1013999|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014000|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014001|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014002|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014003|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014005|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014006|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014007|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
1014008|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014009|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014010|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
1014011|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014012|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014013|NCT00782509|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
1014014|NCT00782509|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
1014015|NCT00782509|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
1014016|NCT00782509|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
1014017|NCT00782509|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
1014018|NCT00782509|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
1014019|NCT00782509|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
1014020|NCT00782509|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
1014021|NCT00782509|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
1014022|NCT00782509|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
1014023|NCT00782509|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
1014024|NCT00782509|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
1014025|NCT00782509|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
1014026|NCT00782509|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
1014027|NCT00782509|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
1014028|NCT00782509|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
1014029|NCT00782509|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
1014030|NCT00782509|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
1014031|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014032|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014033|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014034|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014035|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014036|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014037|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014038|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014039|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014040|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014041|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014042|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014043|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014044|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014045|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014046|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014047|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014048|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014049|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014050|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014051|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014052|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014053|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014054|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014055|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014056|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014057|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014058|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014059|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014060|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014061|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014062|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014063|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014064|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014065|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014066|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014067|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014068|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014069|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014070|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014071|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014072|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014073|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014074|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014075|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014076|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
1014077|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014078|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014079|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014080|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014081|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014082|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014083|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014084|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014085|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014086|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014087|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014088|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014089|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014090|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014091|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014092|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014093|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014094|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014095|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014096|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014097|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014098|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014099|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014100|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014101|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014102|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014103|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014104|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014105|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014106|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014107|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014108|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014109|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014110|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014111|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014112|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014113|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014114|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014115|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014116|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014117|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014118|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
1014119|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014120|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014121|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1015758|NCT00777179|O2|Outcome|Placebo|Matching Placebo
1014122|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014123|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014124|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014125|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014126|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014127|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014128|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014129|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014130|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014131|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014132|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014133|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014134|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014135|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014136|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
1014137|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014138|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014139|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014140|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014141|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014142|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014143|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014144|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014145|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014146|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014147|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014148|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014149|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014150|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014151|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014152|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014153|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014154|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014155|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014156|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014157|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014158|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014159|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014160|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
1014161|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014162|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014163|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
1014164|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014165|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014166|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
1014167|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014168|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014169|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
1014170|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014171|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014172|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
1014173|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014174|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014175|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014176|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014177|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014178|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014179|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014180|NCT00782509|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014181|NCT00782509|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014182|NCT00782509|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1022415|NCT00762788|E3|Reported Event|Lotrafilcon B Contact Lens|O2Optix
1014184|NCT00782509|E3|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014185|NCT00782509|E2|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014186|NCT00782509|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014187|NCT00782496|B3|Baseline|Total|Total of all reporting groups
1014188|NCT00782496|B2|Baseline|Level 2 Advanced Meter Features|Adults with type 1 and type 2 diabetes using advanced meter features.
1014189|NCT00782496|B1|Baseline|Level1 Basic Meter Features|Adults with type 1 and type 2 diabetes using basic meter features
1014190|NCT00782496|P2|Participant Flow|Level 2 Advanced Meter Features|Adults with type 1 and type 2 diabetes using advanced meter features.
1014191|NCT00782496|P1|Participant Flow|Level1 Basic Meter Features|Adults with type 1 and type 2 diabetes using basic meter features
1014192|NCT00782496|O1|Outcome|Level 2 Advanced Meter Features|Adults with type 1 and type 2 diabetes using advanced meter features.
1014193|NCT00782496|O2|Outcome|Level 2 Advanced Meter Features|Adults with type 1 and type 2 diabetes using advanced meter features.
1014194|NCT00782496|O1|Outcome|Level1 Basic Meter Features|Adults with type 1 and type 2 diabetes using basic meter features
1014195|NCT00782496|E2|Reported Event|Level 2 Advanced Meter Features|Adults with type 1 and type 2 diabetes using advanced meter features.
1014196|NCT00782496|E1|Reported Event|Level1 Basic Meter Features|Adults with type 1 and type 2 diabetes using basic meter features
1014197|NCT00782483|B1|Baseline|Overall|Overall Study Group
1014198|NCT00782483|P1|Participant Flow|Laser Therapy|Total number of participants
1014199|NCT00782483|O1|Outcome|Laser Therapy|Total number of participants
1014200|NCT00782483|E1|Reported Event|Overall|Overall Study Group
1014201|NCT00782418|B1|Baseline|All Patients|All patients from all arms
1014202|NCT00782418|P7|Participant Flow|Placebo (HGC or GGI)|Hyperglycemic Clamp or Graded Glucose Infusion: Treatment Group Placebo
1014203|NCT00782418|P6|Participant Flow|GGI - Exenatide 1.5 μg|Graded Glucose Infusion: Treatment Group Exenatide 1.5 μg
1014204|NCT00782418|P5|Participant Flow|GGI - Exenatide 5 μg|Graded Glucose Infusion (GGI): Treatment Group Exenatide 5 μg
1014205|NCT00782418|P4|Participant Flow|Exenatide 5 ug Down Dosed to Placebo (HGC)|Hyperglycemic Clamp: Treatment Group Exenatide 5 ug down dosed to placebo
1014206|NCT00782418|P3|Participant Flow|HGC - Placebo|Hyperglycemic Clamp: Treatment Group Placebo
1014207|NCT00782418|P2|Participant Flow|HGC - Exenatide 1.5 μg|Hyperglycemic Clamp: Treatment Group Exenatide 1.5 μg
1014208|NCT00782418|P1|Participant Flow|HGC - Exenatide 5 μg|Hyperglycemic Clamp (HGC): Treatment Group Exenatide 5 μg
1014209|NCT00782418|O3|Outcome|HGC - Placebo|Hyperglycemic Clamp: Treatment Group Placebo
1014210|NCT00782418|O2|Outcome|HGC - Exenatide 1.5 μg|Hyperglycemic Clamp: Treatment Group Exenatide 1.5 μg
1014211|NCT00782418|O1|Outcome|HGC - Exenatide 5 μg|Hyperglycemic Clamp (HGC): Treatment Group Exenatide 5 μg
1014212|NCT00782418|O3|Outcome|HGC - Placebo|Hyperglycemic Clamp: Treatment Group Placebo
1014213|NCT00782418|O2|Outcome|HGC - Exenatide 1.5 μg|Hyperglycemic Clamp: Treatment Group Exenatide 1.5 μg
1014214|NCT00782418|O1|Outcome|HGC - Exenatide 5 μg|Hyperglycemic Clamp (HGC): Treatment Group Exenatide 5 μg
1014215|NCT00782418|O6|Outcome|GGI - Placebo|Graded Glucose Infusion: Treatment Group Placebo
1014216|NCT00782418|O5|Outcome|GGI - Exenatide 1.5 μg|Graded Glucose Infusion: Treatment Group Exenatide 1.5 μg
1014217|NCT00782418|O4|Outcome|GGI - Exenatide 5 μg|Graded Glucose Infusion (GGI): Treatment Group Exenatide 5 μg
1014218|NCT00782418|O3|Outcome|HGC - Placebo|Hyperglycemic Clamp: Treatment Group Placebo
1014219|NCT00782418|O2|Outcome|HGC - Exenatide 1.5 μg|Hyperglycemic Clamp: Treatment Group Exenatide 1.5 μg
1014220|NCT00782418|O1|Outcome|HGC - Exenatide 5 μg|Hyperglycemic Clamp (HGC): Treatment Group Exenatide 5 μg
1014221|NCT00782418|E6|Reported Event|GGI - Placebo|Graded Glucose Infusion: Treatment Group Placebo
1014222|NCT00782418|E5|Reported Event|GGI - Exenatide 1.5 μg|Graded Glucose Infusion: Treatment Group Exenatide 1.5 μg
1014223|NCT00782418|E4|Reported Event|GGI - Exenatide 5 μg|Graded Glucose Infusion (GGI): Treatment Group Exenatide 5 μg
1014224|NCT00782418|E3|Reported Event|HGC - Placebo|Hyperglycemic Clamp: Treatment Group Placebo
1014225|NCT00782418|E2|Reported Event|HGC - Exenatide 1.5 μg|Hyperglycemic Clamp: Treatment Group Exenatide 1.5 μg
1014226|NCT00782418|E1|Reported Event|HGC - Exenatide 5 μg|Hyperglycemic Clamp (HGC): Treatment Group Exenatide 5 μg
1014227|NCT00782379|B1|Baseline|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
1014228|NCT00782379|P1|Participant Flow|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
1014229|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
1014230|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
1014231|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
1014232|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
1014233|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
1014234|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
1014235|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
1015759|NCT00777179|O1|Outcome|Vandetanib|Vandetanib 300 mg, orally, once daily
1014236|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
1014237|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
1014238|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
1014239|NCT00782379|O1|Outcome|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
1014240|NCT00782379|E1|Reported Event|Haploidentical Transplant|Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant
1014241|NCT00782340|B4|Baseline|Total|Total of all reporting groups
1014242|NCT00782340|B3|Baseline|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1014243|NCT00782340|B2|Baseline|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1014244|NCT00782340|B1|Baseline|Not Randomized|Patients entered open label droxidopa dose titration, but did not proceed into washout and randomization.
1014245|NCT00782340|P3|Participant Flow|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1014246|NCT00782340|P2|Participant Flow|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1014247|NCT00782340|P1|Participant Flow|Open-Label Titration|All patients titrated to their optimal dose of droxidopa for up to 2 weeks during open-label dose titration.
1014248|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1014249|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1014250|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1014251|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1014252|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1014253|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1014254|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1014255|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1014256|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1014283|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
1014257|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1014258|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1014259|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1014260|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1014261|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1014262|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1014263|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1014264|NCT00782340|O2|Outcome|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1014265|NCT00782340|O1|Outcome|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1014266|NCT00782340|E3|Reported Event|Placebo|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1014267|NCT00782340|E2|Reported Event|Droxidopa|"100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1014268|NCT00782340|E1|Reported Event|Open-Label Titration|All patients treated with study drug during dose titration (7-14 days)
1014269|NCT00782288|B4|Baseline|Total|Total of all reporting groups
1014270|NCT00782288|B3|Baseline|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
1014271|NCT00782288|B2|Baseline|Low Dose 0.05 mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
1014272|NCT00782288|B1|Baseline|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
1014273|NCT00782288|P3|Participant Flow|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
1014274|NCT00782288|P2|Participant Flow|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
1014275|NCT00782288|P1|Participant Flow|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
1014276|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
1014277|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
1014278|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
1014279|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
1014280|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
1014281|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
1014282|NCT00782288|O1|Outcome|All Participants|All study participants had nasal cells collected pre and post treatment during the study. Because the data set is extremely large, the full set of microarray data has been deposited in the National Center for Biotechnology Information (NCBI) Gene Expression Omnibus (GEO) this information can be obtained under the accession number.
1014284|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
1014285|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
1014286|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
1014287|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
1014288|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
1014289|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
1014290|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
1014291|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
1014292|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
1014293|NCT00782288|O2|Outcome|Low Dose 0.05 mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
1014294|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
1014295|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
1014296|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
1014297|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
1014298|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
1014299|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
1014300|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
1014301|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
1014302|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
1014303|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
1014304|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
1014305|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
1014306|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
1014307|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
1014308|NCT00782288|O2|Outcome|Low Dose 0.05mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
1014309|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
1014310|NCT00782288|O3|Outcome|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
1014311|NCT00782288|O2|Outcome|Low Dose 0.05 mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
1014312|NCT00782288|O1|Outcome|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
1014313|NCT00782288|E3|Reported Event|Higher Dose 0.1mg Digitoxin|"higher dose 0.1mg digitoxin daily for 28 days~digitoxin: 0.1mg pills, once daily for 28 days."
1014314|NCT00782288|E2|Reported Event|Low Dose 0.05 mg Digitoxin|"low dose 0.05mg digitoxin given once daily for 28 days~digitoxin: 0.05mg tabs, once daily for 28 days"
1014315|NCT00782288|E1|Reported Event|Placebo|"placebo given daily for 28 days~placebo: pill taken once daily for 28 days"
1014316|NCT00782210|B4|Baseline|Total|Total of all reporting groups
1014317|NCT00782210|B3|Baseline|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014318|NCT00782210|B2|Baseline|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014319|NCT00782210|B1|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014320|NCT00782210|P3|Participant Flow|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014321|NCT00782210|P2|Participant Flow|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014322|NCT00782210|P1|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014323|NCT00782210|O3|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014324|NCT00782210|O2|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014325|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014326|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014327|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014328|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014329|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014330|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014331|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014332|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014333|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014334|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014335|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014336|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014337|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014338|NCT00782210|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
1014339|NCT00782210|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
1014340|NCT00782210|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
1014341|NCT00782210|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
1014342|NCT00782210|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
1014343|NCT00782210|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
1014344|NCT00782210|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
1014345|NCT00782210|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
1014346|NCT00782210|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
1014347|NCT00782210|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
1014348|NCT00782210|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
1014349|NCT00782210|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
1014350|NCT00782210|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
1014351|NCT00782210|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
1014352|NCT00782210|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
1014353|NCT00782210|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
1014354|NCT00782210|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
1014355|NCT00782210|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
1014356|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014357|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014358|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014359|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014360|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014361|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014362|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014363|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014364|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014365|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014366|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014367|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014368|NCT00782210|O3|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014369|NCT00782210|O2|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014370|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014371|NCT00782210|O3|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014372|NCT00782210|O2|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014373|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014374|NCT00782210|O3|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014375|NCT00782210|O2|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014376|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014377|NCT00782210|O3|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014378|NCT00782210|O2|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014379|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014380|NCT00782210|O3|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014381|NCT00782210|O2|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014382|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014383|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014384|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014385|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014386|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014387|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014388|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014389|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014390|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014391|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014392|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014393|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014394|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014395|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014396|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014397|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014398|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014399|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014400|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014401|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
1014402|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014403|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014404|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014405|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014406|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014407|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014408|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014409|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014410|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014411|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014412|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014413|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014414|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014415|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014416|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014417|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014418|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014419|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014420|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014421|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014422|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014423|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014424|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014425|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014426|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014427|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014428|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014429|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014430|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014431|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014432|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014433|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014434|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014435|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014436|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014437|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014438|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014439|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014440|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014441|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014442|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014443|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
1014444|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014445|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014446|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014447|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014448|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014449|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014450|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014451|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014452|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1015760|NCT00777179|O2|Outcome|Placebo|Matching Placebo
1014453|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014454|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014455|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014456|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014457|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014458|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014459|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014460|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014461|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
1014462|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014463|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014464|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014465|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014466|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014467|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014468|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014469|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014470|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014471|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014472|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014473|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014474|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014475|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014476|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014477|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014478|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014479|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014480|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014481|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014482|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014483|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014484|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014485|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
1014486|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014487|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014488|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
1014489|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014490|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014491|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
1014492|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014493|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014494|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
1014495|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014496|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014497|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
1014498|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014499|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014500|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014501|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014502|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014503|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014504|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014505|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014506|NCT00782210|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014507|NCT00782210|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014508|NCT00782210|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014509|NCT00782210|E3|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1014510|NCT00782210|E2|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1014511|NCT00782210|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1014512|NCT00782184|B3|Baseline|Total|Total of all reporting groups
1014566|NCT00781963|O1|Outcome|Arm 1|"Individual-Behavioral Sleep Intervention~Individual-behavioral sleep intervention: A manual-based behavioral sleep intervention provided by allied health personnel in individual sessions."
1014513|NCT00782184|B2|Baseline|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
1014514|NCT00782184|B1|Baseline|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
1014515|NCT00782184|P2|Participant Flow|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
1014516|NCT00782184|P1|Participant Flow|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
1014517|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
1014518|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
1014519|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
1014520|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
1014521|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
1014522|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
1014523|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
1014524|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
1014525|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
1014526|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
1014527|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
1014528|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
1014529|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
1014530|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
1014531|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
1014532|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
1014533|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
1014534|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
1014535|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
1014536|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
1014537|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
1014686|NCT00781456|O2|Outcome|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
1014538|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
1014539|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
1014540|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
1014541|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
1014542|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
1014543|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
1014544|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
1014545|NCT00782184|O2|Outcome|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
1014546|NCT00782184|O1|Outcome|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
1014547|NCT00782184|E3|Reported Event|Placebo|One participant received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, the participant was randomized to the ezetimbe/simvastatin group, but took only pills from the bottle containing placebo to atorvastatin during the 6-week double-blind treatment period.
1014548|NCT00782184|E2|Reported Event|Atorvastatin 40 mg|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period.
1014549|NCT00782184|E1|Reported Event|Ezetimibe/Simvastatin 10/40|Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period.
1014550|NCT00782067|B1|Baseline|Midostaurin (PKC412)|Midostaurin was administered at a dose of 100 mg twice daily (bid) in continuous cycles of 28 days until disease progression, intolerable toxicity or withdrawal due to any cause, whichever occurred first.
1014551|NCT00782067|P1|Participant Flow|Midostaurin (PKC412)|Midostaurin was administered at a dose of 100 mg twice daily (bid) in continuous cycles of 28 days until disease progression, intolerable toxicity or withdrawal due to any cause, whichever occurred first.
1014552|NCT00782067|O1|Outcome|Midostaurin (PKC412)|Midostaurin was administered at a dose of 100 mg twice daily (bid) in continuous cycles of 28 days until disease progression, intolerable toxicity or withdrawal due to any cause, whichever occurred first.
1014553|NCT00782067|O1|Outcome|Midostaurin (PKC412)|Midostaurin was administered at a dose of 100 mg twice daily (bid) in continuous cycles of 28 days until disease progression, intolerable toxicity or withdrawal due to any cause, whichever occurred first.
1014554|NCT00782067|O1|Outcome|Midostaurin (PKC412)|Midostaurin was administered at a dose of 100 mg twice daily (bid) in continuous cycles of 28 days until disease progression, intolerable toxicity or withdrawal due to any cause, whichever occurred first.
1014555|NCT00782067|O1|Outcome|Midostaurin (PKC412)|Midostaurin was administered at a dose of 100 mg twice daily (bid) in continuous cycles of 28 days until disease progression, intolerable toxicity or withdrawal due to any cause, whichever occurred first.
1014556|NCT00782067|E1|Reported Event|Midostaurin (PKC412)|Midostaurin was administered at a dose of 100 mg twice daily (bid) in continuous cycles of 28 days until disease progression, intolerable toxicity or withdrawal due to any cause, whichever occurred first.
1014557|NCT00781963|B4|Baseline|Total|Total of all reporting groups
1014558|NCT00781963|B3|Baseline|Control|"Group-based Behavioral Sleep Intervention II~Group-based behavioral sleep intervention II: A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions"
1014559|NCT00781963|B2|Baseline|Group CBTI|"Group-based Behavioral Sleep Intervention I~Group-based behavioral sleep intervention I: A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions"
1014560|NCT00781963|B1|Baseline|Individual CBTI|"Individual-Behavioral Sleep Intervention~Individual-behavioral sleep intervention: A manual-based behavioral sleep intervention provided by allied health personnel in individual sessions."
1014561|NCT00781963|P3|Participant Flow|Arm 3|"Group-based Behavioral Sleep Intervention II~Group-based behavioral sleep intervention II: A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions"
1014562|NCT00781963|P2|Participant Flow|Arm 2|"Group-based Behavioral Sleep Intervention I~Group-based behavioral sleep intervention I: A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions"
1014563|NCT00781963|P1|Participant Flow|Arm 1|"Individual-Behavioral Sleep Intervention~Individual-behavioral sleep intervention: A manual-based behavioral sleep intervention provided by allied health personnel in individual sessions."
1014564|NCT00781963|O3|Outcome|Arm 3|"Group-based Behavioral Sleep Intervention II~Group-based behavioral sleep intervention II: A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions"
1014565|NCT00781963|O2|Outcome|Arm 2|"Group-based Behavioral Sleep Intervention I~Group-based behavioral sleep intervention I: A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions"
1014567|NCT00781963|E3|Reported Event|Arm 3|"Group-based Behavioral Sleep Intervention II~Group-based behavioral sleep intervention II: A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions"
1014568|NCT00781963|E2|Reported Event|Arm 2|"Group-based Behavioral Sleep Intervention I~Group-based behavioral sleep intervention I: A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions"
1014569|NCT00781963|E1|Reported Event|Arm 1|"Individual-Behavioral Sleep Intervention~Individual-behavioral sleep intervention: A manual-based behavioral sleep intervention provided by allied health personnel in individual sessions."
1014570|NCT00781950|B3|Baseline|Total|Total of all reporting groups
1014571|NCT00781950|B2|Baseline|Flaxseed|"Randomized, Blinded group of patients that will be given food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing 30 g of milled flaxseed daily for one year~Flaxseed: 30 grams of milled flaxseed per day in food products or on its own."
1014572|NCT00781950|B1|Baseline|Placebo|Randomized, Blinded Controlled Arm of patients receiving placebo food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing a mixture of wheat, wheat bran, and mixed dietary oils to replace the flaxseed daily for one year.
1014573|NCT00781950|P2|Participant Flow|Flaxseed|"Randomized, Blinded group of patients that will be given food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing 30 g of milled flaxseed daily for one year~Flaxseed: 30 grams of milled flaxseed per day in food products or on its own."
1014574|NCT00781950|P1|Participant Flow|Placebo|Randomized, Blinded Controlled Arm of patients receiving placebo food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing a mixture of wheat, wheat bran, and mixed dietary oils to replace the flaxseed daily for one year.
1014575|NCT00781950|O2|Outcome|Flaxseed|"Randomized, Blinded group of patients that will be given food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing 30 g of milled flaxseed daily for one year~Flaxseed: 30 grams of milled flaxseed per day in food products or on its own."
1014576|NCT00781950|O1|Outcome|Placebo|Randomized, Blinded Controlled Arm of patients receiving placebo food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing a mixture of wheat, wheat bran, and mixed dietary oils to replace the flaxseed daily for one year.
1014577|NCT00781950|O2|Outcome|Flaxseed|"Randomized, Blinded group of patients that will be given food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing 30 g of milled flaxseed daily for one year~Flaxseed: 30 grams of milled flaxseed per day in food products or on its own."
1014578|NCT00781950|O1|Outcome|Placebo|Randomized, Blinded Controlled Arm of patients receiving placebo food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing a mixture of wheat and wheat bran to replace the flaxseed daily for one year.
1014579|NCT00781950|E2|Reported Event|Flaxseed|"Randomized, Blinded group of patients that will be given food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing 30 g of milled flaxseed daily for one year~Flaxseed: 30 grams of milled flaxseed per day in food products or on its own."
1014580|NCT00781950|E1|Reported Event|Placebo|Randomized, Blinded Controlled Arm of patients receiving placebo food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing a mixture of wheat, wheat bran, and mixed dietary oils to replace the flaxseed daily for one year.
1014581|NCT00781937|B3|Baseline|Total|Total of all reporting groups
1014582|NCT00781937|B2|Baseline|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
1014583|NCT00781937|B1|Baseline|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
1014584|NCT00781937|P2|Participant Flow|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
1014585|NCT00781937|P1|Participant Flow|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
1014586|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
1014587|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
1014588|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
1014589|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
1014590|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
1014591|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
1014592|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
1014593|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
1014594|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
1014595|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
1014596|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
1014597|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
1014598|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
1014599|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
1014600|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
1014601|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
1014602|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
1014687|NCT00781456|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
1022416|NCT00762788|E2|Reported Event|Lotrafilcon A Contact Lens|NIGHT&DAY
1014603|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
1014604|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
1014605|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
1014606|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
1014607|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
1014608|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
1014609|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
1014610|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
1014611|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
1014612|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
1014613|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
1014614|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
1014615|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
1014616|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
1014688|NCT00781456|O2|Outcome|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
1014866|NCT00780572|O2|Outcome|Arm 2: Control/No Alerts|The second arm is the control. Alerts will not be displayed for these patients.
1014617|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
1014618|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
1014619|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
1014620|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
1014621|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
1014622|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
1014623|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
1014624|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
1014625|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
1014626|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
1014627|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
1014628|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
1014629|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
1014630|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
1014689|NCT00781456|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
1022780|NCT00762424|P2|Participant Flow|Placebo|placebo: cornstarch
1014631|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
1014632|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
1014633|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
1014634|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
1014635|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
1014636|NCT00781937|O2|Outcome|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
1014637|NCT00781937|O1|Outcome|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
1014638|NCT00781937|E2|Reported Event|Placebo|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
1014639|NCT00781937|E1|Reported Event|Lira 3.0 mg|A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached
1014640|NCT00781859|B3|Baseline|Total|Total of all reporting groups
1014641|NCT00781859|B2|Baseline|Placebo|Intravitreal injection of placebo
1014642|NCT00781859|B1|Baseline|Ocriplasmin 125µg|125µg microplasmin intravitreal injection
1014643|NCT00781859|P2|Participant Flow|Placebo|Intravitreal injection of placebo
1014644|NCT00781859|P1|Participant Flow|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection
1014645|NCT00781859|O2|Outcome|Placebo|Intravitreal injection of placebo
1014646|NCT00781859|O1|Outcome|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection
1014647|NCT00781859|O2|Outcome|Placebo|Intravitreal injection of placebo
1014648|NCT00781859|O1|Outcome|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection
1014649|NCT00781859|E2|Reported Event|Placebo|Intravitreal injection of placebo
1014650|NCT00781859|E1|Reported Event|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection
1014651|NCT00781599|B3|Baseline|Total|Total of all reporting groups
1014652|NCT00781599|B2|Baseline|Chantix for 3 Months and Adherence Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
1014653|NCT00781599|B1|Baseline|Chantix for 3 Months, Standard Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
1014654|NCT00781599|P2|Participant Flow|Chantix for 3 Months and Adherence Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
1014655|NCT00781599|P1|Participant Flow|Chantix for 3 Months, Standard Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
1015197|NCT00778999|B2|Baseline|Non-Oral Contraceptive|No use of oral contraceptive pills prior to controlled ovarian stimulation
1014656|NCT00781599|O2|Outcome|Chantix for 3 Months and Adherence Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
1014657|NCT00781599|O1|Outcome|Chantix for 3 Months, Standard Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
1014658|NCT00781599|O2|Outcome|Chantix for 3 Months and Adherence Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
1014659|NCT00781599|O1|Outcome|Chantix for 3 Months, Standard Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
1014660|NCT00781599|O2|Outcome|Chantix for 3 Months and Adherence Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
1014661|NCT00781599|O1|Outcome|Chantix for 3 Months, Standard Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
1014662|NCT00781599|O2|Outcome|Chantix for 3 Months and Adherence Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
1014663|NCT00781599|O1|Outcome|Chantix for 3 Months, Standard Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
1014664|NCT00781599|E2|Reported Event|Chantix for 3 Months and Adherence Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit. Participants received 5 additional counseling sessions. Adherence counseling based on the Information-Motivation-Behavioral Skills model.
1014665|NCT00781599|E1|Reported Event|Chantix for 3 Months, Standard Counseling|Participants received Chantix for 3 months. Participants received verbal instructions on how to take the medication. Participants met with a study counselor during randomization visit to develop a plan to quit.
1014666|NCT00781508|B3|Baseline|Total|Total of all reporting groups
1014667|NCT00781508|B2|Baseline|Placebo First Sildenafil Second|Effect of placebo on left ventricular filling pressures in patients with heart failure
1014668|NCT00781508|B1|Baseline|Sildenafil First Placebo Second|Effect of sildenafil on left ventricular filling pressures in patients with heart failure
1014669|NCT00781508|P2|Participant Flow|Placebo Then Sildenafil|Effect of Sildenafil on left ventricular function
1014670|NCT00781508|P1|Participant Flow|Sildenafil Then Placebo|Effect of sildenafil on left ventricular filling pressures in patients with heart failure
1014671|NCT00781508|O2|Outcome|Placebo First Then Sildenafil|placebo orally, then sildenafil 50 mg orally 2 days later.
1014672|NCT00781508|O1|Outcome|Sildenafil First Then Placebo|Sildenafil 50 mg orally, placebo orally 2 days later.
1014673|NCT00781508|O2|Outcome|Placebo First Then Sildenafil|placebo administered orally, then sildenafil orally 48 hrs later
1014674|NCT00781508|O1|Outcome|Sildenafil First Then Placebo|sildenafil 50 mg administered orally, placebo administered orally 48 hrs later
1014675|NCT00781508|E2|Reported Event|Placebo First Then Sildenafil|Effect of placebo on left ventricular filing pressures, then effect of sildenafil on left ventricular filling pressure.
1014676|NCT00781508|E1|Reported Event|Sildenafil First Then Placebo|Effect of sildenafil first on left ventricular filling pressures, then effect of placebo on left ventricular filling pressure
1014677|NCT00781456|B3|Baseline|Total|Total of all reporting groups
1014678|NCT00781456|B2|Baseline|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
1014679|NCT00781456|B1|Baseline|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
1014680|NCT00781456|P2|Participant Flow|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
1014681|NCT00781456|P1|Participant Flow|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
1014682|NCT00781456|O2|Outcome|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
1014683|NCT00781456|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
1014684|NCT00781456|O2|Outcome|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
1014685|NCT00781456|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
1023000|NCT00762229|E2|Reported Event|Ezetimibe 5 mg|Ezetimibe 5 mg,
1014690|NCT00781456|O2|Outcome|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
1014691|NCT00781456|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
1014692|NCT00781456|O2|Outcome|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
1014693|NCT00781456|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
1014694|NCT00781456|O2|Outcome|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
1014695|NCT00781456|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
1014696|NCT00781456|O2|Outcome|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
1014697|NCT00781456|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
1014698|NCT00781456|E2|Reported Event|Placebo|Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.
1014699|NCT00781456|E1|Reported Event|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.
1014700|NCT00781391|B4|Baseline|Total|Total of all reporting groups
1014701|NCT00781391|B3|Baseline|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
1014702|NCT00781391|B2|Baseline|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
1014703|NCT00781391|B1|Baseline|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
1014704|NCT00781391|P3|Participant Flow|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
1014705|NCT00781391|P2|Participant Flow|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
1014706|NCT00781391|P1|Participant Flow|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
1014707|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
1014708|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
1014709|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
1014710|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
1014711|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
1014712|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
1014713|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
1014714|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
1014715|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
1014716|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
1014717|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
1015198|NCT00778999|B1|Baseline|Oral Contraceptive|Use of oral contraceptive pills prior to controlled ovarian stimulation
1014718|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
1014719|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
1014720|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
1014721|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
1014722|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
1014723|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
1014724|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
1014725|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
1014726|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
1014727|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
1014728|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
1014729|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
1014730|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
1014731|NCT00781391|O3|Outcome|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
1014732|NCT00781391|O2|Outcome|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~60mg Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
1014733|NCT00781391|O1|Outcome|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~30mg Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
1014734|NCT00781391|E3|Reported Event|Low Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~Edoxaban tablets (low dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
1014735|NCT00781391|E2|Reported Event|High Dose Edoxaban/Placebo Warfarin|"Edoxaban tablets plus warfarin placebo tablets~Edoxaban tablets (high dose regimen): Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months~placebo warfarin: placebo warfarin"
1014736|NCT00781391|E1|Reported Event|Warfarin/Placebo Edoxaban|"Warfarin tablets plus placebo Edoxaban tablets~warfarin tablets: Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months~placebo edoxaban: placebo edoxaban"
1014737|NCT00781365|B3|Baseline|Total|Total of all reporting groups
1014738|NCT00781365|B2|Baseline|Telemonitoring Intervention|"The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.~Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist."
1014739|NCT00781365|B1|Baseline|Usual Care|Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
1014740|NCT00781365|P2|Participant Flow|Usual Care|Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
1014741|NCT00781365|P1|Participant Flow|Telemonitoring Intervention|"The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.~Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist."
1014766|NCT00780416|E1|Reported Event|TRV/PEG/RBV|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
1014767|NCT00780403|B1|Baseline|Total Population|All randomized subjects.
1015199|NCT00778999|P2|Participant Flow|Non-Oral Contraceptive|No use of oral contraceptive pills prior to controlled ovarian stimulation
1014742|NCT00781365|O2|Outcome|Telemonitoring Intervention|"The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.~Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist."
1014743|NCT00781365|O1|Outcome|Usual Care|Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
1014744|NCT00781365|O2|Outcome|Telemonitoring Intervention|"The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.~Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist."
1014745|NCT00781365|O1|Outcome|Usual Care|Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
1014746|NCT00781365|O2|Outcome|Telemonitoring Intervention|"The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.~Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist."
1014747|NCT00781365|O1|Outcome|Usual Care|Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
1014748|NCT00781365|E2|Reported Event|Telemonitoring Intervention|"The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.~Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist."
1014749|NCT00781365|E1|Reported Event|Usual Care|Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
1014750|NCT00781326|B1|Baseline|Open Label Antidepressant|In Phase 1, all participants will be placed on antidepressant medication. In Phase 2, participants will continue with their antidepressant medication and also receive receive either nimodipine or placebo.
1014751|NCT00781326|P1|Participant Flow|Open Label Antidepressant|In Phase 1, all participants will be placed on antidepressant medication. In Phase 2, participants will continue with their antidepressant medication and also receive receive either nimodipine or placebo.
1014752|NCT00781326|O1|Outcome|Open Label Antidepressant|"In Phase 1, all participants will be placed on antidepressant medication. In Phase 2, participants will continue with their antidepressant medication and also receive receive either nimodipine or placebo.~Nimodipine: Nimodipine will be initiated at one, 30-mg tablet three times a day for 1 week, increased to 2 tablets three times a day for 1 week, and then increased to three tablets three times a day for the remaining 30 weeks of the study. Participants who cannot tolerate the maximum dose of 270 mg/day will be maintained at the highest tolerable dose.~Placebo: Placebo will be given in doses matching those of nimodipine."
1014753|NCT00781326|E1|Reported Event|Open Label Antidepressant|In Phase 1, all participants will be placed on antidepressant medication. In Phase 2, participants will continue with their antidepressant medication and also receive receive either nimodipine or placebo.
1014754|NCT00781274|B1|Baseline|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
1014755|NCT00781274|P1|Participant Flow|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
1014756|NCT00781274|O1|Outcome|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
1014757|NCT00781274|E1|Reported Event|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
1014758|NCT00780416|B3|Baseline|Total|Total of all reporting groups
1014759|NCT00780416|B2|Baseline|PEG/RBV|"Drug: Ribavirin 600 - 1000 mg/day based on body weight for 48 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 48 weeks"
1014760|NCT00780416|B1|Baseline|TRV/PEG/RBV|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
1014761|NCT00780416|P2|Participant Flow|PEG/RBV|"Drug: Ribavirin 600 - 1000 mg/day based on body weight for 48 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 48 weeks"
1014762|NCT00780416|P1|Participant Flow|TRV/PEG/RBV|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
1014763|NCT00780416|O2|Outcome|PEG/RBV|"Drug: Ribavirin 600 - 1000 mg/day based on body weight for 48 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 48 weeks"
1014764|NCT00780416|O1|Outcome|TRV/PEG/RBV|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
1014765|NCT00780416|E2|Reported Event|PEG/RBV|"Drug: Ribavirin 600 - 1000 mg/day based on body weight for 48 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 48 weeks"
1015200|NCT00778999|P1|Participant Flow|Oral Contraceptive|Use of oral contraceptive pills prior to controlled ovarian stimulation
1014768|NCT00780403|P2|Participant Flow|Zyrtec/RediTab|Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine RediTab (first and second intervention period).
1014769|NCT00780403|P1|Participant Flow|RediTab/Zyrtec|Subjects received a single dose of desloratadine Reditab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet (first and second intervention period).
1014770|NCT00780403|O3|Outcome|No Preference|All randomized subjects.
1014771|NCT00780403|O2|Outcome|Zyrtec|All randomized subjects.
1014772|NCT00780403|O1|Outcome|RediTab|All randomized subjects.
1014773|NCT00780403|E2|Reported Event|Zyrtec/RediTab|Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine RediTab (first and second intervention period).
1014774|NCT00780403|E1|Reported Event|RediTab/Zyrtec|Subjects received a single dose of desloratadine Reditab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet (first and second intervention period).
1014775|NCT00780338|B3|Baseline|Total|Total of all reporting groups
1014776|NCT00780338|B2|Baseline|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
1014777|NCT00780338|B1|Baseline|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
1014778|NCT00780338|P2|Participant Flow|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
1014779|NCT00780338|P1|Participant Flow|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
1014780|NCT00780338|O2|Outcome|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
1014781|NCT00780338|O1|Outcome|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
1014782|NCT00780338|O2|Outcome|AGTO Group - Non Users of AGTO|Those assigned to AGTO but did not participate in the intervention at all.
1014783|NCT00780338|O1|Outcome|AGTO Group - Users of AGTO|Those assigned to AGTO who used at least some portion of the intervention.
1014784|NCT00780338|O2|Outcome|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
1014785|NCT00780338|O1|Outcome|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
1014786|NCT00780338|O2|Outcome|AGTO Group - Non AGTO Users|Those assigned to AGTO intervention, but did NOT participate in the AGTO intervention.
1014787|NCT00780338|O1|Outcome|AGTO Group - AGTO Users|Those assigned to AGTO intervention, but did participate in the AGTO intervention.
1014788|NCT00780338|O2|Outcome|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
1014834|NCT00780741|P2|Participant Flow|Deferred Facility Probing - Participants With Unilateral NLDO|Probing to be performed in a surgical facility under general anesthesia within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
1014789|NCT00780338|O1|Outcome|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
1014790|NCT00780338|O2|Outcome|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
1014791|NCT00780338|O1|Outcome|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
1014792|NCT00780338|O2|Outcome|AGTO Group - Non Users of AGTO|Those assigned to AGTO but did not participate in the intervention at all.
1014793|NCT00780338|O1|Outcome|AGTO Group - Users of AGTO|Those assigned to AGTO who used at least some portion of the intervention.
1014794|NCT00780338|O2|Outcome|AGTO Group - Non Users of AGTO|Those assigned to AGTO but did not participate in the intervention at all.
1014795|NCT00780338|O1|Outcome|AGTO Group - Users of AGTO|Those assigned to AGTO who used at least some portion of the intervention.
1014796|NCT00780338|O2|Outcome|AGTO Group - Non AGTO Users|Those assigned to AGTO intervention, but did NOT participate in the AGTO intervention.
1014797|NCT00780338|O1|Outcome|AGTO Group - AGTO Users|Those assigned to AGTO intervention, but did participate in the AGTO intervention.
1014798|NCT00780338|O2|Outcome|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
1014799|NCT00780338|O1|Outcome|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
1014800|NCT00780338|O2|Outcome|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
1014801|NCT00780338|O1|Outcome|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
1014802|NCT00780338|O2|Outcome|Control Group|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
1014803|NCT00780338|O1|Outcome|AGTO Group|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes : Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
1014804|NCT00780338|E2|Reported Event|Control|"Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.~Assets Getting To Outcomes: Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
1014835|NCT00780741|P1|Participant Flow|Immediate Office Probing - Participants With Unilateral NLDO|Probing to be performed in the office setting using topical anesthesia and infant restraint. Probing to be performed either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
1014805|NCT00780338|E1|Reported Event|AGTO|"Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.~Assets Getting To Outcomes: Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance"
1014806|NCT00778375|B1|Baseline|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
1014807|NCT00778375|P1|Participant Flow|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 by vein (IV) as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
1014808|NCT00778375|O1|Outcome|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
1014809|NCT00778375|O1|Outcome|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
1014810|NCT00778375|O2|Outcome|Re-Induction|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
1014811|NCT00778375|O1|Outcome|Induction Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
1014812|NCT00778375|O1|Outcome|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
1014813|NCT00778375|O1|Outcome|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
1014814|NCT00778375|O1|Outcome|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
1014815|NCT00778375|E1|Reported Event|Clofarabine + Cytarabine + Decitabine|Clofarabine 20 mg/m^2 IV as 1-2 hour intravenous infusion daily for 5 days; Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3-6 hours following start of clofarabine infusions; Decitabine 20 mg/m^2 as 1-2 hour infusion daily for 5 days.
1014816|NCT00781079|B3|Baseline|Total|Total of all reporting groups
1014817|NCT00781079|B2|Baseline|Arm 2|Care as usual
1014818|NCT00781079|B1|Baseline|Arm 1|Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)
1014819|NCT00781079|P2|Participant Flow|Arm 2|Care as usual
1014820|NCT00781079|P1|Participant Flow|Arm 1|"Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)~Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA): Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)"
1014821|NCT00781079|O2|Outcome|Care as Usual|Care as usual on the case management teams
1014822|NCT00781079|O1|Outcome|Consumer Provider|Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)
1014823|NCT00781079|O2|Outcome|Care as Usual|Care as usual on the case management teams
1014824|NCT00781079|O1|Outcome|Consumer Provider|Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)
1014825|NCT00781079|E2|Reported Event|Case as Usual|Care as usual on case management teams
1014826|NCT00781079|E1|Reported Event|Consumer Provider|Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)
1014827|NCT00780910|B1|Baseline|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
1014828|NCT00780910|P1|Participant Flow|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
1014829|NCT00780910|O1|Outcome|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
1014830|NCT00780910|E1|Reported Event|MP-424|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks"
1014831|NCT00780741|B3|Baseline|Total|Total of all reporting groups
1014832|NCT00780741|B2|Baseline|Deferred Facility Probing - Participants With Unilateral NLDO|Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
1014833|NCT00780741|B1|Baseline|Immediate Office Probing - Participants With Unilateral NLDO|Probing to be performed in the office either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
1014836|NCT00780741|O1|Outcome|Immediate Office Probing - Participants With Unilateral NLDO|Probing to be performed in the office either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
1014837|NCT00780741|O1|Outcome|Deferred Facility Probing - Participants With Unilateral NLDO|Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist.
1014838|NCT00780741|O2|Outcome|Deferred Facility Probing - Participants With Unilateral NLDO|Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
1014839|NCT00780741|O1|Outcome|Immediate Office Probing - Participants With Unilateral NLDO|Probing to be performed in the office either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
1014840|NCT00780741|O2|Outcome|Deferred Facility Probing - Participants With Unilateral NLDO|Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
1014841|NCT00780741|O1|Outcome|Immediate Office Probing - Participants With Unilateral NLDO|Probing to be performed in the office either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
1014842|NCT00780741|O2|Outcome|Deferred Facility Probing - Participants With Unilateral NLDO|Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
1014843|NCT00780741|O1|Outcome|Immediate Office Probing - Participants With Unilateral NLDO|Probing to be performed in the office either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
1014844|NCT00780741|E2|Reported Event|Deferred Facility Probing - Participants With Unilateral NLDO|Probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
1014845|NCT00780741|E1|Reported Event|Immediate Office Probing - Participants With Unilateral NLDO|Probing to be performed in the office either the same day as randomization or within two weeks. Limited to participants with unilateral nasolacrimal duct obstruction (NLDO).
1014846|NCT00780676|B6|Baseline|Total|Total of all reporting groups
1014847|NCT00780676|B5|Baseline|MEK Pathway Predictor Negative|Participants predicted to respond to selumetinib/AZD6244 by predictive gene signature (MEK pathway predictor negative) receive selumetinib 75 mg by mouth twice daily (BID).
1014848|NCT00780676|B4|Baseline|MEK Pathway Activity Predictor Positive|Participants predicted to respond to selumetinib/AZD6244 by predictive gene signature (either MEK pathway activity predictor positive or MEK pathway predictor negative) receive selumetinib 75 mg by mouth twice daily (BID).
1014849|NCT00780676|B3|Baseline|Dasatinib Target Index|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
1014850|NCT00780676|B2|Baseline|SRC Pathway Activity Signature|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
1014851|NCT00780676|B1|Baseline|Dasatinib Sensitivity Signature|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
1014852|NCT00780676|P5|Participant Flow|MEK Pathway Predictor Negative|Participants predicted to respond to selumetinib/AZD6244 by predictive gene signature (MEK pathway predictor negative) receive selumetinib 75 mg by mouth twice daily (BID).
1014853|NCT00780676|P4|Participant Flow|MEK Pathway Activity Predictor Positive|Participants predicted to respond to selumetinib/AZD6244 by predictive gene signature (MEK pathway activity predictor positive) receive selumetinib 75 mg by mouth twice daily (BID).
1014854|NCT00780676|P3|Participant Flow|Dasatinib Target Index|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
1014855|NCT00780676|P2|Participant Flow|SRC Pathway Activity Signature|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
1014856|NCT00780676|P1|Participant Flow|Dasatinib Sensitivity Signature|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
1014857|NCT00780676|O3|Outcome|Dasatinib Target Index|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
1014858|NCT00780676|O2|Outcome|SRC Pathway Activity Signature|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
1014859|NCT00780676|O1|Outcome|Dasatinib Sensitivity Signature|Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
1014860|NCT00780676|E1|Reported Event|Dasatinib 100 mg|Participants with one of 3 predictive gene signatures (dasatinib sensitivity signature, SRC pathway activity signature and dasatinib target index) received Dasatinib 100 mg orally daily.
1014861|NCT00780572|B3|Baseline|Total|Total of all reporting groups
1014862|NCT00780572|B2|Baseline|Arm 2: Control/No Alerts|The second arm is the control. Alerts will not be displayed for these patients.
1014863|NCT00780572|B1|Baseline|Arm 1: ADE Alerts|"Arm 1 is a random intervention group in which half of the patients admitted to the VASLCHCS during study time period will be randomly selected. Providers will see ADE alerts for all patient in the randomly selected experimental group~ADE alert assistant: A note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories."
1014864|NCT00780572|P2|Participant Flow|Arm 2: Control/No Alerts|The second arm is the control. Alerts will not be displayed for these patients.
1014865|NCT00780572|P1|Participant Flow|Arm 1: ADE Alerts|"Arm 1 is a random intervention group in which half of the patients admitted to the VASLCHCS during study time period will be randomly selected. Providers will see ADE alerts for all patient in the randomly selected experimental group~ADE alert assistant: A note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories."
1015761|NCT00777179|O1|Outcome|Vandetanib|Vandetanib 300 mg, orally, once daily
1014867|NCT00780572|O1|Outcome|Arm 1: ADE Alerts|"Arm 1 is a random intervention group in which half of the patients admitted to the VASLCHCS during study time period will be randomly selected. Providers will see ADE alerts for all patient in the randomly selected experimental group~ADE alert assistant: A note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories."
1014868|NCT00780572|E2|Reported Event|Arm 2: Control/No Alert|The second arm is the control. Alerts will not be displayed for these patients.
1014869|NCT00780572|E1|Reported Event|Arm 1: ADE Alerts|"Arm 1 is a random intervention group in which half of the patients admitted to the VASLCHCS during study time period will be randomly selected. Providers will see ADE alerts for all patient in the randomly selected experimental group~ADE alert assistant: A note in CPRS alerting providers that patients are at risk for an adverse event based on prescription and lab value histories."
1014870|NCT00780455|B3|Baseline|Total|Total of all reporting groups
1014871|NCT00780455|B2|Baseline|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
1014872|NCT00780455|B1|Baseline|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
1014873|NCT00780455|P2|Participant Flow|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
1014874|NCT00780455|P1|Participant Flow|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
1014875|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
1014876|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
1014877|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
1014878|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
1014879|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
1014880|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
1014881|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
1014882|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
1014883|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
1014884|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
1014885|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
1015201|NCT00778999|O2|Outcome|Non-Oral Contraceptive|No use of oral contraceptive pills prior to controlled ovarian stimulation
1014886|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
1014887|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
1014888|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
1014889|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
1014890|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
1014891|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
1014892|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
1014893|NCT00780455|O2|Outcome|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
1014894|NCT00780455|O1|Outcome|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
1014895|NCT00780455|E2|Reported Event|Interferon Beta-1b, FRP About 6 Weeks After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
1014896|NCT00780455|E1|Reported Event|Interferon Beta-1b, FRP Within 15 Days After Randomization|Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation.
1014897|NCT00780273|B1|Baseline|Dental Implants.|"3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.~Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant in split mouth study.~A total of 19 subjects participated in this randomized, split-mouth, masked, prospective, open, comparison, monocenter study. Participants were subjects with an edentulous mandible who received 3 implants on each side which were splinted for the delivery of a fixed prosthesis.~After a baseline phase of 1 month the mandible sides of subjects were randomly assigned to one of 2 parallel treatment groups: one side received ANKYLOS® plus Implants. The contralateral side received Certain® PREVAILTM Implants. Abutments were installed and loaded immediately by a fixed temporary bridge. After 3 months the final prosthesis was incorporated."
1014898|NCT00780273|P1|Participant Flow|Dental Implants.|"3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.~Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant in split mouth study.~A total of 19 subjects participated in this randomized, split-mouth, masked, prospective, open, comparison, monocenter study. Participants were subjects with an edentulous mandible who received 3 implants on each side which were splinted for the delivery of a fixed prosthesis.~After a baseline phase of 1 month the mandible sides of subjects were randomly assigned to one of 2 parallel treatment groups: one side received ANKYLOS® plus Implants. The contralateral side received Certain® PREVAILTM Implants. Abutments were installed and loaded immediately by a fixed temporary bridge. After 3 months the final prosthesis was incorporated."
1014899|NCT00780273|O2|Outcome|3i Prevail Dental Implants.|"Three 3i Prevail dental implants placed on the opposite side of the mandible from the Ankylos implants in support of fixed dental restoration.~Biomet 3i Prevail Implants"
1014900|NCT00780273|O1|Outcome|Ankylos Dental Implants.|"3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.~Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant"
1014901|NCT00780273|O2|Outcome|3i Prevail Dental Implants.|"Three 3i Prevail dental implants placed on the opposite side of the mandible from the Ankylos implants in support of fixed dental restoration.~Biomet 3i Prevail Implants"
1014902|NCT00780273|O1|Outcome|Ankylos Dental Implants.|"3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.~Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant"
1015202|NCT00778999|O1|Outcome|Oral Contraceptive|Use of oral contraceptive pills prior to controlled ovarian stimulation
1014903|NCT00780273|O2|Outcome|3i Prevail Dental Implants.|"Three 3i Prevail dental implants placed on the opposite side of the mandible from the Ankylos implants in support of fixed dental restoration.~Biomet 3i Prevail Implants"
1014904|NCT00780273|O1|Outcome|Ankylos Dental Implants.|"3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.~Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant"
1014905|NCT00780273|E1|Reported Event|Dental Implants.|"3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.~Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant in split mouth study."
1014906|NCT00779857|B1|Baseline|AtriCure LAA Exclusion System|"AtriCure LAA Exclusion System~AtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System"
1014907|NCT00779857|P1|Participant Flow|AtriCure LAA Exclusion System|"AtriCure LAA Exclusion System~AtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System"
1014908|NCT00779857|O1|Outcome|AtriCure LAA Exclusion System|"AtriCure LAA Exclusion System~AtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System"
1014909|NCT00779857|O1|Outcome|AtriCure LAA Exclusion System|"AtriCure LAA Exclusion System~AtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System"
1014910|NCT00779857|E1|Reported Event|AtriCure LAA Exclusion System|"AtriCure LAA Exclusion System~AtriCure LAA Exclusion System : Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System"
1014911|NCT00779779|B1|Baseline|Rotarix Group|Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
1014912|NCT00779779|P1|Participant Flow|Rotarix Group|Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
1014913|NCT00779779|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
1014914|NCT00779779|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
1014915|NCT00779779|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
1014916|NCT00779779|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
1014917|NCT00779779|E1|Reported Event|Rotarix Group|Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
1014918|NCT00779766|B3|Baseline|Total|Total of all reporting groups
1014919|NCT00779766|B2|Baseline|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014920|NCT00779766|B1|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014921|NCT00779766|P2|Participant Flow|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014922|NCT00779766|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014923|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014924|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014925|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule
1014926|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014927|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014928|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014929|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014930|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014931|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule
1014932|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule
1014933|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014934|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014935|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014936|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014937|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014938|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014939|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014940|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014941|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014942|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014943|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014944|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014945|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014946|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014947|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014948|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014949|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014950|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014951|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014952|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014953|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014954|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014955|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014956|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014957|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014958|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014959|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014960|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014961|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014962|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014963|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014964|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1015203|NCT00778999|E2|Reported Event|Non-Oral Contraceptive|No use of oral contraceptive pills prior to controlled ovarian stimulation
1014965|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014966|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014967|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014968|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014969|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014970|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014971|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014972|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014973|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014974|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014975|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014976|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014977|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014978|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014979|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014980|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014981|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014982|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014983|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014984|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014985|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014986|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014987|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014988|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014989|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014990|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014991|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014992|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014993|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014994|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014995|NCT00779766|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1015204|NCT00778999|E1|Reported Event|Oral Contraceptive|Use of oral contraceptive pills prior to controlled ovarian stimulation
1014996|NCT00779766|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014997|NCT00779766|E2|Reported Event|Placebo Group|Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014998|NCT00779766|E1|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
1014999|NCT00779701|B1|Baseline|Insulin Infusion|"All subjects placed on insulin infusion.~Insulin: Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL"
1015000|NCT00779701|P1|Participant Flow|Insulin Infusion|"All subjects placed on insulin infusion.~Insulin: Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL"
1015001|NCT00779701|O1|Outcome|Insulin Infusion|"All subjects placed on insulin infusion.~Insulin: Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL"
1015002|NCT00779701|E1|Reported Event|Insulin Infusion|"All subjects placed on insulin infusion.~Insulin: Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL"
1015003|NCT00779675|B1|Baseline|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
1015004|NCT00779675|P1|Participant Flow|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
1015005|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
1015006|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
1015007|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
1015008|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
1015009|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
1015010|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg of body weight at Weeks 0, 2, 6, and then every 8 weeks (Week 14, 22, 30, 38, and 46 for the Treatment Period and Weeks 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada, summary of product characteristics (SPC; European Union), or local labelling (for all other countries).
1015011|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg of body weight at Weeks 0, 2, 6, and then every 8 weeks (Week 14, 22, 30, 38, and 46 for the Treatment Period and Weeks 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada, summary of product characteristics (SPC; European Union), or local labelling (for all other countries).
1015012|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg of body weight at Weeks 0, 2, 6, and then every 8 weeks (Week 14, 22, 30, 38, and 46 for the Treatment Period and Weeks 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada, summary of product characteristics (SPC; European Union), or local labelling (for all other countries).
1015013|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg of body weight at Weeks 0, 2, 6, and then every 8 weeks (Week 14, 22, 30, 38, and 46 for the Treatment Period and Weeks 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada, summary of product characteristics (SPC; European Union), or local labelling (for all other countries).
1015014|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg of body weight at Week 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Weeks 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characterisitics (SPC; European Union), or local labelling (for all other countries).
1015015|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2,6, and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Weeks 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labelling (for all other Countries)
1015047|NCT00779506|O1|Outcome|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
1015016|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labelling (for all other Countries).
1015017|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
1015018|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
1015019|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
1015020|NCT00779675|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
1015021|NCT00779675|E1|Reported Event|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
1015022|NCT00779558|B3|Baseline|Total|Total of all reporting groups
1015023|NCT00779558|B2|Baseline|Placebo|Placebo - normal saline infusion
1015024|NCT00779558|B1|Baseline|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour~Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
1015025|NCT00779558|P2|Participant Flow|Placebo|Placebo - normal saline infusion
1015026|NCT00779558|P1|Participant Flow|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour~Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
1015027|NCT00779558|O2|Outcome|Placebo|Placebo - normal saline infusion
1015028|NCT00779558|O1|Outcome|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour~Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
1015029|NCT00779558|O2|Outcome|Placebo|Placebo - normal saline infusion
1015030|NCT00779558|O1|Outcome|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour~Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
1015031|NCT00779558|O2|Outcome|Placebo|Placebo - normal saline infusion
1015032|NCT00779558|O1|Outcome|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour~Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
1015033|NCT00779558|O2|Outcome|Placebo|Placebo - normal saline infusion
1015034|NCT00779558|O1|Outcome|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour~Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
1015035|NCT00779558|O2|Outcome|Placebo|Placebo - normal saline infusion
1015036|NCT00779558|O1|Outcome|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour~Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
1015037|NCT00779558|E2|Reported Event|Placebo|Placebo - normal saline infusion
1015038|NCT00779558|E1|Reported Event|Study Drug|"Heparin sulfate infusion at 10 units/kg/hour~Heparin sulfate infusion at 10 units/kg/hour: Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery"
1015039|NCT00779506|B1|Baseline|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
1015040|NCT00779506|P1|Participant Flow|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
1015041|NCT00779506|O1|Outcome|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
1015042|NCT00779506|O1|Outcome|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
1015043|NCT00779506|O1|Outcome|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
1015044|NCT00779506|O1|Outcome|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
1015045|NCT00779506|O1|Outcome|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
1015046|NCT00779506|O1|Outcome|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
1015048|NCT00779506|E1|Reported Event|Quetiapine XR|This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
1015049|NCT00779467|B5|Baseline|Total|Total of all reporting groups
1015050|NCT00779467|B4|Baseline|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION~Bupivacaine~fentanyl: fentanyl 2 mcg/ml"
1015051|NCT00779467|B3|Baseline|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
1015052|NCT00779467|B2|Baseline|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
1015053|NCT00779467|B1|Baseline|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
1015054|NCT00779467|P4|Participant Flow|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION~Bupivacaine~fentanyl: fentanyl 2 mcg/ml"
1015055|NCT00779467|P3|Participant Flow|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
1015056|NCT00779467|P2|Participant Flow|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
1015057|NCT00779467|P1|Participant Flow|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
1015058|NCT00779467|O4|Outcome|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION~Bupivacaine~fentanyl: fentanyl 2 mcg/ml"
1015059|NCT00779467|O3|Outcome|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
1015060|NCT00779467|O2|Outcome|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
1015061|NCT00779467|O1|Outcome|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
1015062|NCT00779467|O4|Outcome|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION~Bupivacaine~fentanyl: fentanyl 2 mcg/ml"
1015063|NCT00779467|O3|Outcome|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
1015064|NCT00779467|O2|Outcome|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
1015065|NCT00779467|O1|Outcome|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
1015066|NCT00779467|O4|Outcome|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION~Bupivacaine~fentanyl: fentanyl 2 mcg/ml"
1015067|NCT00779467|O3|Outcome|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
1015068|NCT00779467|O2|Outcome|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
1015069|NCT00779467|O1|Outcome|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
1015070|NCT00779467|O4|Outcome|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION~Bupivacaine~fentanyl: fentanyl 2 mcg/ml"
1015071|NCT00779467|O3|Outcome|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
1015072|NCT00779467|O2|Outcome|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
1015073|NCT00779467|O1|Outcome|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
1015074|NCT00779467|O4|Outcome|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION~Bupivacaine~fentanyl: fentanyl 2 mcg/ml"
1015075|NCT00779467|O3|Outcome|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
1015076|NCT00779467|O2|Outcome|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
1015134|NCT00779259|O1|Outcome|1 Hour Before Morning Dose of Quinine on Study Day 11|measured 1 hour prior to the morning dose of Quinine on study Day 11
1015077|NCT00779467|O1|Outcome|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
1015078|NCT00779467|O4|Outcome|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION~Bupivacaine~fentanyl: fentanyl 2 mcg/ml"
1015079|NCT00779467|O3|Outcome|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
1015080|NCT00779467|O2|Outcome|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
1015081|NCT00779467|O1|Outcome|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
1015082|NCT00779467|O4|Outcome|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION~Bupivacaine~fentanyl: fentanyl 2 mcg/ml"
1015083|NCT00779467|O3|Outcome|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
1015084|NCT00779467|O2|Outcome|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
1015085|NCT00779467|O1|Outcome|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
1015086|NCT00779467|O4|Outcome|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION~Bupivacaine~fentanyl: fentanyl 2 mcg/ml"
1015087|NCT00779467|O3|Outcome|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
1015088|NCT00779467|O2|Outcome|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
1015089|NCT00779467|O1|Outcome|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
1015090|NCT00779467|E4|Reported Event|BUPIVACAINE WITH FENTANYL 2 MCG/ML|"Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION~Bupivacaine~fentanyl: fentanyl 2 mcg/ml"
1015091|NCT00779467|E3|Reported Event|Bupivacaine With Neostigmine 2 mcg/ml|"STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
1015092|NCT00779467|E2|Reported Event|Bupivacaine and Neostigmine 4 mcg/ml|"STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
1015093|NCT00779467|E1|Reported Event|Bupivacaine With Neostimgine 8 mcg/ml|"STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML~Neostigmine: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.~Bupivacaine"
1015094|NCT00779311|B6|Baseline|Total|Total of all reporting groups
1015095|NCT00779311|B5|Baseline|Dose Level (DL) 5 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 400mg twice a day.
1015096|NCT00779311|B4|Baseline|Dose Level (DL) 4 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day.
1015097|NCT00779311|B3|Baseline|Dose Level (DL) 3 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day, 5 days on followed by 2 days off.
1015098|NCT00779311|B2|Baseline|Dose Level (DL) 2 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every day.
1015099|NCT00779311|B1|Baseline|Dose Level (DL) 1 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every other day.
1015100|NCT00779311|P5|Participant Flow|Dose Level (DL) 5 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 400mg twice a day.
1015101|NCT00779311|P4|Participant Flow|Dose Level (DL) 4 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day.
1015102|NCT00779311|P3|Participant Flow|Dose Level (DL) 3 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day, 5 days on followed by 2 days off.
1015103|NCT00779311|P2|Participant Flow|Dose Level (DL) 2 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every day.
1015104|NCT00779311|P1|Participant Flow|Dose Level (DL) 1 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every other day.
1015105|NCT00779311|O5|Outcome|Dose Level (DL) 5 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 400mg twice a day.
1015205|NCT00778921|B4|Baseline|Total|Total of all reporting groups
1015106|NCT00779311|O4|Outcome|Dose Level (DL) 4 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day.
1015107|NCT00779311|O3|Outcome|Dose Level (DL) 3 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day, 5 days on followed by 2 days off.
1015108|NCT00779311|O2|Outcome|Dose Level (DL) 2 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every day.
1015109|NCT00779311|O1|Outcome|Dose Level (DL) 1 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every other day.
1015110|NCT00779311|O5|Outcome|Dose Level (DL) 5 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 400mg twice a day.
1015111|NCT00779311|O4|Outcome|Dose Level (DL) 4 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day.
1015112|NCT00779311|O3|Outcome|Dose Level (DL) 3 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day, 5 days on followed by 2 days off.
1015113|NCT00779311|O2|Outcome|Dose Level (DL) 2 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every day.
1015114|NCT00779311|O1|Outcome|Dose Level (DL) 1 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every other day.
1015115|NCT00779311|O5|Outcome|Dose Level (DL) 5 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 400mg twice a day.
1015116|NCT00779311|O4|Outcome|Dose Level (DL) 4 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day.
1015117|NCT00779311|O3|Outcome|Dose Level (DL) 3 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day, 5 days on followed by 2 days off.
1015118|NCT00779311|O2|Outcome|Dose Level (DL) 2 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every day.
1015119|NCT00779311|O1|Outcome|Dose Level (DL) 1 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every other day.
1015120|NCT00779311|E5|Reported Event|Dose Level (DL) 5 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 400mg twice a day.
1015121|NCT00779311|E4|Reported Event|Dose Level (DL) 4 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day.
1015122|NCT00779311|E3|Reported Event|Dose Level (DL) 3 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg twice a day, 5 days on followed by 2 days off.
1015123|NCT00779311|E2|Reported Event|Dose Level (DL) 2 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every day.
1015124|NCT00779311|E1|Reported Event|Dose Level (DL) 1 for MTD Determination|All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle, and sorafenib 200mg every other day.
1015125|NCT00779285|B1|Baseline|Caelyx|Pegylated Lyposomal Doxorubicin (Caelyx) 50 mg/m2, given for 6 cycles
1015126|NCT00779285|P1|Participant Flow|Caelyx|Pegylated Lyposomal Doxorubicin (Caelyx) 50 mg/m2, given for 6 cycles
1015127|NCT00779285|O1|Outcome|Caelyx|Pegylated Lyposomal Doxorubicin (Caelyx) 50 mg/m2, given for 6 cycles
1015128|NCT00779285|E1|Reported Event|Caelyx|Pegylated Lyposomal Doxorubicin (Caelyx) 50 mg/m2, given for 6 cycles
1015129|NCT00779259|B1|Baseline|Theophylline Alone, Quinine Alone, Theophylline With Quinine|This study was done in two cohorts, each receiving the same dosing regimen. For each cohort, all subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80 mg/15 ml concentration) at 7:00am on Day 1 following an overnight fast of at least 10 hours. After a 4-day washout period, subjects received 648 mg of quinine sulfate (2 x 324 mg capsules) every 8 hours (dosing occurred at 7am, 3pm and 11pm daily) starting with the 3pm dose on Day 5 and continuing through the morning dose on Day 12. Subjects also received a single 300 mg dose of theophylline along with their 648 mg quinine sulfate dose on the morning of Day 12.
1015130|NCT00779259|P1|Participant Flow|Theophylline Alone, Quinine Alone, Theophylline With Quinine|This study was done in two cohorts, each receiving the same dosing regimen. For each cohort, all subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80 mg/15 ml concentration) at 7:00am on Day 1 following an overnight fast of at least 10 hours. After a 4-day washout period, subjects received 648 mg of quinine sulfate (2 x 324 mg capsules) every 8 hours (dosing occurred at 7am, 3pm and 11pm daily) starting with the 3pm dose on Day 5 and continuing through the morning dose on Day 12. Subjects also received a single 300 mg dose of theophylline along with their 648 mg quinine sulfate dose on the morning of Day 12.
1015131|NCT00779259|O2|Outcome|4 Hours After Co-Administered Dose of Theophylline/Quinine|measured 4 hours after the 7 am co-administered dose of theophylline and quinine
1015132|NCT00779259|O1|Outcome|1 Hour Before Co-Administered Dose of Theophylline/Quinine|measured 1 hour prior to the 7 am co-administered dose of theophylline and quinine
1015133|NCT00779259|O2|Outcome|4 Hours After Morning Dose of Quinine on Study Day 11|measured 4 hours after the morning dose of quinine
1015135|NCT00779259|O2|Outcome|Theophylline in Presence of Quinine|At 7am on Day 12 after a fast of at least 10 hours, subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml) and quinine sulfate (2 x 324 mg capsules).
1015136|NCT00779259|O1|Outcome|Theophylline Alone|At 7am on Day 1 after a fast of at least 10 hours, all subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml)followed by a 4 day washout period
1015137|NCT00779259|O4|Outcome|Quinine in Presence of Theophylline|At 7am on Day 12 after a fast of at least 10 hours, subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml) and quinine sulfate (2 x 324 mg capsules).
1015138|NCT00779259|O3|Outcome|Theophylline in Presence of Quinine|At 7am on Day 12 after a fast of at least 10 hours, subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml) and quinine sulfate (2 x 324 mg capsules).
1015139|NCT00779259|O2|Outcome|Quinine Alone|On Day 5 in the afternoon, dosing of quinine sulfate (2 x 324 mg capsules) was initiated and continued every 8 hours without regard to meals through Day 11
1015140|NCT00779259|O1|Outcome|Theophylline Alone|At 7am on Day 1 after a fast of at least 10 hours, all subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml)followed by a 4 day washout period
1015141|NCT00779259|O4|Outcome|Quinine in the Presence of Theophylline|At 7am on Day 12 after a fast of at least 10 hours, subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml concentration) and quinine sulfate (2 x 324 mg capsules).
1015142|NCT00779259|O3|Outcome|Theophylline in the Presence of Quinine|At 7am on Day 12 after a fast of at least 10 hours, subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml concentration) and quinine sulfate (2 x 324 mg capsules).
1015143|NCT00779259|O2|Outcome|Quinine Alone|On Day 5 in the afternoon, dosing of quinine sulfate (2 x 324 mg capsules) was initiated and continued every 8 hours without regard to meals through Day 11.
1015144|NCT00779259|O1|Outcome|Theophylline Alone|At 7am on Day 1 after a fast of at least 10 hours, all subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80mg/15ml concentration)followed by a 4-day washout period.
1015145|NCT00779259|E3|Reported Event|Theophylline Co-administered With Quinine|At 7am on Day 12 after a fast of at least 10 hours, subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80 mg/15 ml) and quinine sulfate (2 x 324 mg capsules).
1015146|NCT00779259|E2|Reported Event|Quinine Alone|On Day 5 in the afternoon, dosing of quinine sulfate (2 x 324 mg capsules) was initiated and continued every 8 hours without regard to meals through Day 11
1015147|NCT00779259|E1|Reported Event|Theophylline Alone|At 7am on Day 1 after a fast of at least 10 hours, all subjects received a single dose of theophylline (300 mg as an immediate-release oral solution 80 mg/15 ml)followed by a 4 day washout period
1015148|NCT00779246|B3|Baseline|Total|Total of all reporting groups
1015149|NCT00779246|B2|Baseline|Chlorhexidine Gluconate (CHG)|Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures will also be performed but results will be blinded for duration of study and will not be used to determine need for contact isolation.
1015150|NCT00779246|B1|Baseline|Active Surveillance Cultures|Active surveillance cultures (via nasal swabs) will be performed for all patients admitted to the medical ICU during the designated study period. Participants will remain in contact isolation until results return as negative.
1015151|NCT00779246|P2|Participant Flow|Chlorhexidine Gluconate (CHG)|Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures will also be performed but results will be blinded for duration of study and will not be used to determine need for contact isolation.
1015152|NCT00779246|P1|Participant Flow|Active Surveillance Cultures|Active surveillance cultures (via nasal swabs) will be performed for all patients admitted to the medical ICU during the designated study period. Participants will remain in contact isolation until results return as negative.
1015153|NCT00779246|O2|Outcome|Chlorhexidine Gluconate (CHG)|Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures will be performed but results will be blinded and not used to determine need for contact isolation.
1015154|NCT00779246|O1|Outcome|Active Surveillance Cultures (ASC)|Active surveillance cultures (via nasal swabs) will be performed for all patients admitted to the medical ICU during the designated study period. Patient will remain in contact isolation until results returned as negative.
1015155|NCT00779246|E2|Reported Event|Chlorhexidine Gluconate (CHG)|Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures will also be performed but results will be blinded for duration of study and will not be used to determine need for contact isolation.
1015156|NCT00779246|E1|Reported Event|Active Surveillance Cultures|Active surveillance cultures (via nasal swabs) will be performed for all patients admitted to the medical ICU during the designated study period. Participants will remain in contact isolation until results return as negative.
1015157|NCT00779155|B3|Baseline|Total|Total of all reporting groups
1015158|NCT00779155|B2|Baseline|Active Resonator Device|Active pico-tesla magnetic fields
1015159|NCT00779155|B1|Baseline|Inactive Resonator Device|inactive magnetic fields with placebo fields
1015160|NCT00779155|P2|Participant Flow|Active Resonator Device|Active pico-tesla magnetic fields
1015161|NCT00779155|P1|Participant Flow|Inactive Resonator Device|inactive magnetic fields with placebo fields
1015162|NCT00779155|O2|Outcome|Active Resonator Device|Active pico-tesla magnetic fields
1015163|NCT00779155|O1|Outcome|Inactive Resonator Device|inactive magnetic fields with placebo fields
1015164|NCT00779155|E2|Reported Event|Active Resonator Device|Active pico-tesla magnetic fields
1015165|NCT00779155|E1|Reported Event|Inactive Resonator Device|inactive magnetic fields with placebo fields
1015166|NCT00779142|B1|Baseline|Methotrexate 25mg/ml|Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample.
1015193|NCT00779025|O2|Outcome|YOURS and MINE|Male Personal Lubricant (10855-096) used in conjunction with Female Personal Lubricant (PD-F-5254)
1015167|NCT00779142|P1|Participant Flow|Methotrexate 25mg/ml|"Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample.~Methotrexate intravenous 25mg/ml: Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample."
1015168|NCT00779142|O1|Outcome|Methotrexate 25mg/ml|"Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample.~Methotrexate intravenous 25mg/ml: Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample."
1015169|NCT00779142|E1|Reported Event|Methotrexate 25mg/ml|"Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample.~Methotrexate intravenous 25mg/ml: Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample."
1015170|NCT00779116|B1|Baseline|Total Population|All randomized subjects
1015171|NCT00779116|P2|Participant Flow|Zyrtec/RediTab|Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine Reditab.
1015172|NCT00779116|P1|Participant Flow|RediTab/Zyrtec|Subjects received a single dose of desloratadine Reditab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet.
1015173|NCT00779116|O3|Outcome|No Preference|All randomized subjects.
1015174|NCT00779116|O2|Outcome|Zyrtec|All randomized subjects.
1015175|NCT00779116|O1|Outcome|RediTab|All randomized subjects.
1015176|NCT00779116|E2|Reported Event|Zyrtec/RediTab|Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine Reditab (first and second intervention period).
1015177|NCT00779116|E1|Reported Event|RediTab/Zyrtec|Subjects received a single dose of desloratadine Reditab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet (first and second intervention period).
1015178|NCT00779038|B1|Baseline|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
1015179|NCT00779038|P1|Participant Flow|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS [a device which uses an electric current to move drug through the skin into the blood]), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
1015180|NCT00779038|O1|Outcome|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
1015181|NCT00779038|O1|Outcome|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
1015182|NCT00779038|O1|Outcome|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
1015183|NCT00779038|O1|Outcome|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
1015184|NCT00779038|O1|Outcome|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
1015185|NCT00779038|O1|Outcome|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
1015186|NCT00779038|E1|Reported Event|Fentanyl ITS|Participants received 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
1015187|NCT00779025|B1|Baseline|Overall Study (ITT)|The group evaluated was based on intention to treat (ITT).
1015188|NCT00779025|P1|Participant Flow|Overall Study (ITT)|The group evaluated was based on intention to treat (ITT).
1015189|NCT00779025|O2|Outcome|YOURS and MINE|Male Personal Lubricant (10855-096) used in conjunction with Female Personal Lubricant (PD-F-5254)
1015190|NCT00779025|O1|Outcome|MINE Alone|Female Personal Lubricant (PD-F-5254)
1015191|NCT00779025|O2|Outcome|YOURS and MINE|Male Personal Lubricant (10855-096) used in conjunction with Female Personal Lubricant (PD-F-5254)
1015192|NCT00779025|O1|Outcome|MINE Alone|Female Personal Lubricant (PD-F-5254)
1015206|NCT00778921|B3|Baseline|Amlodipine 10 mg|Oral capsules of amlodipine 10 mg taken once daily with water in the morning
1015207|NCT00778921|B2|Baseline|Aliskiren/Amlodipine 150/10 mg|Oral tablets of combination aliskiren/amlodipine 150/10 mg taken once daily with water in the morning
1015208|NCT00778921|B1|Baseline|Aliskiren/Amlodipine 300/10 mg|Oral tablets of combination aliskiren/amlodipine 300/10 mg taken once daily with water in the morning
1015209|NCT00778921|P3|Participant Flow|Amlodipine 10 mg|Oral capsules of amlodipine 10 mg taken once daily with water in the morning
1015210|NCT00778921|P2|Participant Flow|Aliskiren/Amlodipine 150/10 mg|Oral tablets of combination aliskiren/amlodipine 150/10 mg taken once daily with water in the morning
1015211|NCT00778921|P1|Participant Flow|Aliskiren/Amlodipine 300/10 mg|Oral tablets of combination aliskiren/amlodipine 300/10 mg taken once daily with water in the morning
1015212|NCT00778921|O3|Outcome|Amlodipine 10 mg|Oral capsules of amlodipine 10 mg taken once daily with water in the morning
1015213|NCT00778921|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|Oral tablets of combination aliskiren/amlodipine 150/10 mg taken once daily with water in the morning
1015214|NCT00778921|O1|Outcome|Aliskiren/Amlodipine 300/10 mg|Oral tablets of combination aliskiren/amlodipine 300/10 mg taken once daily with water in the morning
1015215|NCT00778921|O3|Outcome|Amlodipine 10 mg|Oral capsules of amlodipine 10 mg taken once daily with water in the morning
1015216|NCT00778921|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|Oral tablets of combination aliskiren/amlodipine 150/10 mg taken once daily with water in the morning
1015217|NCT00778921|O1|Outcome|Aliskiren/Amlodipine 300/10 mg|Oral tablets of combination aliskiren/amlodipine 300/10 mg taken once daily with water in the morning
1015218|NCT00778921|O3|Outcome|Amlodipine 10 mg|Oral capsules of amlodipine 10 mg taken once daily with water in the morning
1015219|NCT00778921|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|Oral tablets of combination aliskiren/amlodipine 150/10 mg taken once daily with water in the morning
1015220|NCT00778921|O1|Outcome|Aliskiren/Amlodipine 300/10 mg|Oral tablets of combination aliskiren/amlodipine 300/10 mg taken once daily with water in the morning
1015221|NCT00778921|E3|Reported Event|Amlodipine 10mg|Amlodipine 10mg
1015222|NCT00778921|E2|Reported Event|Aliskiren 150mg/ Amlodipine 10mg|Aliskiren 150mg/ Amlodipine 10mg
1015223|NCT00778921|E1|Reported Event|Aliskiren 300mg/ Amlodipine 10mg|Aliskiren 300mg/ Amlodipine 10mg
1015224|NCT00778895|B4|Baseline|Total|Total of all reporting groups
1015225|NCT00778895|B3|Baseline|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015226|NCT00778895|B2|Baseline|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015227|NCT00778895|B1|Baseline|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015228|NCT00778895|P3|Participant Flow|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015229|NCT00778895|P2|Participant Flow|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015230|NCT00778895|P1|Participant Flow|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015231|NCT00778895|O1|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015232|NCT00778895|O1|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015233|NCT00778895|O1|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015234|NCT00778895|O1|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015235|NCT00778895|O1|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015367|NCT00778622|E1|Reported Event|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
1015368|NCT00778336|B5|Baseline|Total|Total of all reporting groups
1015236|NCT00778895|O1|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015237|NCT00778895|O1|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015238|NCT00778895|O3|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015239|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015240|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015241|NCT00778895|O3|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015242|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015243|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015244|NCT00778895|O3|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015245|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015246|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015247|NCT00778895|O3|Outcome|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015248|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015249|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015250|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015251|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015252|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015253|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015369|NCT00778336|B4|Baseline|Other Thrombotic Conditions|Patients with a thrombotic Condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access treated with a midlength AngioJet catheter.
1015254|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015255|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015256|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015257|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015258|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015259|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015260|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015261|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015262|NCT00778895|O2|Outcome|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015263|NCT00778895|O1|Outcome|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015264|NCT00778895|E3|Reported Event|Vaxigrip Group|Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015265|NCT00778895|E2|Reported Event|Fluviral F2 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015266|NCT00778895|E1|Reported Event|Fluviral F1 Group|Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
1015267|NCT00778869|B1|Baseline|Remicade|Remicade will be given as an intravenous infusion at a dose of 5 mg/kg at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54.
1015268|NCT00778869|P1|Participant Flow|Remicade|Remicade will be given as an intravenous infusion at a dose of 5 mg/kg at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54.
1015269|NCT00778869|O1|Outcome|Remicade|Remicade will be given as an intravenous infusion at a dose of 5 mg/kg at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54 in participants with AS.
1015270|NCT00778869|E1|Reported Event|Remicade|Remicade will be given as an intravenous infusion at a dose of 5 mg/kg at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54.
1015271|NCT00778830|B3|Baseline|Total|Total of all reporting groups
1015272|NCT00778830|B2|Baseline|Cetuximab Plus FOLFOX|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfox (Oxaliplatin administered intravenously at a dose of 180 mg/m^2, folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
1015273|NCT00778830|B1|Baseline|Cetuximab Plus FOLFIRI|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfiri (Irinotecan administered intravenously at a dose of 180 mg/m^2 ,folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
1015762|NCT00777179|E2|Reported Event|Placebo|Matching Placebo
1015274|NCT00778830|P2|Participant Flow|Cetuximab Plus FOLFOX|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfox (Oxaliplatin administered intravenously at a dose of 180 mg/m^2, folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
1015275|NCT00778830|P1|Participant Flow|Cetuximab Plus FOLFIRI|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfiri (Irinotecan administered intravenously at a dose of 180 mg/m^2 ,folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
1015276|NCT00778830|O2|Outcome|Cetuximab Plus FOLFOX|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfox (Oxaliplatin administered intravenously at a dose of 180 mg/m^2, folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
1015277|NCT00778830|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfiri (Irinotecan administered intravenously at a dose of 180 mg/m^2 ,folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
1015278|NCT00778830|O2|Outcome|Cetuximab Plus FOLFOX|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfox (Oxaliplatin administered intravenously at a dose of 180 mg/m^2, folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
1015279|NCT00778830|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfiri (Irinotecan administered intravenously at a dose of 180 mg/m^2 ,folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
1015280|NCT00778830|O2|Outcome|Cetuximab Plus FOLFOX|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfox (Oxaliplatin administered intravenously at a dose of 180 mg/m^2, folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
1015281|NCT00778830|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfiri (Irinotecan administered intravenously at a dose of 180 mg/m^2 ,folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
1015282|NCT00778830|O2|Outcome|Cetuximab Plus FOLFOX|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfox (Oxaliplatin administered intravenously at a dose of 180 mg/m^2, folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
1015283|NCT00778830|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfiri (Irinotecan administered intravenously at a dose of 180 mg/m^2 ,folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent.
1015284|NCT00778830|E2|Reported Event|Cetuximab Plus FOLFOX|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly until disease progression, death, or consent withdrawal. Oxaliplatin was administered intravenously at a dose of 100 mg/m^2 along with folinic acid intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form) and 5-fluorouracil at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion of 2,400 mg/m^2 given biweekly until disease progression, death, or consent withdrawal.
1015285|NCT00778830|E1|Reported Event|Cetuximab Plus FOLFIRI|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly until disease progression, death, or consent withdrawal. Irinotecan was administered intravenously at a dose of 180 mg/m^2 along with folinic acid intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form) and 5-fluorouracil at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion of 2,400 mg/m^2 given biweekly until disease progression, death, or consent withdrawal.
1015286|NCT00778817|B1|Baseline|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
1015287|NCT00778817|P1|Participant Flow|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
1015288|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
1015289|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
1015290|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
1015291|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
1015292|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
1015293|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
1015294|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
1015295|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
1015296|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
1015297|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
1015298|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
1015299|NCT00778817|O1|Outcome|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
1015300|NCT00778817|E1|Reported Event|Chemotherapy and Monoclonal Antibody Therapy|Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
1015301|NCT00778648|B3|Baseline|Total|Total of all reporting groups
1015302|NCT00778648|B2|Baseline|Placebo|
1015303|NCT00778648|B1|Baseline|Juice Plus|
1015304|NCT00778648|P2|Participant Flow|Placebo|
1015305|NCT00778648|P1|Participant Flow|Juice Plus|
1015306|NCT00778648|O2|Outcome|Placebo|
1015307|NCT00778648|O1|Outcome|Juice Plus|
1015308|NCT00778648|E2|Reported Event|Placebo|
1015309|NCT00778648|E1|Reported Event|Juice Plus|
1015310|NCT00778622|B4|Baseline|Total|Total of all reporting groups
1015311|NCT00778622|B3|Baseline|Glucophage XR in Obese Participants|Obese was defined as body mass index (BMI) greater than, equal to 28 kg/m^2. Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
1015312|NCT00778622|B2|Baseline|Glucophage XR in Overweight Participants|Overweight was defined as body mass index (BMI) greater than, equal to 24 kg/m^2 and less than 28 kg/m^2. Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
1015313|NCT00778622|B1|Baseline|Glucophage XR in Normal Weight Participants|Normal weight was defined as body mass index (BMI) greater than, equal to 18.5 kg/m^2 and < 24 kg/m^2 ). Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
1015314|NCT00778622|P3|Participant Flow|Glucophage XR in Obese Participants|Obese was defined as body mass index (BMI) greater than, equal to (>=) 28 kg/m^2. Initial dose of Glucophage extended release (XR)on Day 1 was 500 mg taken once daily orally with the evening meal. Drug was titrated up by increments of 500 mg each week to a maximum dose of 2000 mg at Week 4 and for the remaining treatment if the fasting plasma glucose (FPG) was greater than 7.0 mmol/L (126 mg/dL). If the FPG was more than 10.0 mmol/L (greater than 180 mg/dL) at Weeks 4, 8, or 12 and the values were confirmed at a repeated measurement, the participant was discontinued from the treatment. Participants were dosed for a total of 16 weeks
1015315|NCT00778622|P2|Participant Flow|Glucophage XR in Overweight Participants|Overweight was defined as body mass index (BMI) greater than, equal to (>=) 24 kg/m^2 and less than (<) 28 kg/m^2. Initial dose of Glucophage extended release (XR) on Day 1 was 500 mg taken once daily orally with the evening meal. Drug was titrated up by increments of 500 mg each week to a maximum dose of 2000 mg at Week 4 and for the remaining treatment if the fasting plasma glucose (FPG) was greater than 7.0 mmol/L (126 mg/dL). If the FPG was more than 10.0 mmol/L (greater than 180 mg/dL) at Weeks 4, 8, or 12 and the values were confirmed at a repeated measurement, the participant was discontinued from the treatment. Participants were dosed for a total of 16 weeks
1015316|NCT00778622|P1|Participant Flow|Glucophage XR in Normal Weight Participants|Normal weight was defined as body mass index (BMI) greater than, equal to (>=)18.5 kilogram per meter squared (kg/m^2) and less than (<) 24 kg/m^2. Initial dose of Glucophage extended release (XR) on Day 1 was 500 mg taken once daily orally with the evening meal. Drug was titrated up by increments of 500 mg each week to a maximum dose of 2000 mg at Week 4 and for the remaining treatment if the fasting plasma glucose (FPG) was greater than 7.0 mmol/L (126 mg/dL). If the FPG was more than 10.0 mmol/L (greater than 180 mg/dL) at Weeks 4, 8, or 12 and the values were confirmed at a repeated measurement, the participant was discontinued from the treatment. Participants were dosed for a total of 16 weeks.
1023901|NCT00760578|O3|Outcome|Pioglitazone|Pioglitazone 45 mg once daily
1015317|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as body mass index (BMI) greater than, equal to 28 kg/m^2. Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
1015318|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight was defined as body mass index (BMI) greater than, equal to 24 kg/m^2 and less than 28 kg/m^2. Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
1015319|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight was defined as body mass index (BMI) greater than, equal to 18.5 kg/m^2 and < 24 kg/m^2 ). Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
1015320|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
1015321|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
1015322|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
1015323|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
1015324|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
1015325|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
1015326|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
1015327|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
1015328|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
1015329|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
1015330|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
1015331|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
1015332|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
1015333|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
1015334|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
1015335|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
1015336|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
1015337|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
1015338|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
1015339|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
1015340|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
1015341|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
1015342|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
1015343|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
1015344|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
1015345|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
1015346|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
1015347|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
1015348|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
1015349|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
1015350|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
1015351|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
1015352|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
1015353|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
1015354|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
1015355|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
1015356|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
1015357|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
1015358|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
1015359|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
1015360|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
1015361|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 ).
1015362|NCT00778622|O3|Outcome|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
1015363|NCT00778622|O2|Outcome|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
1015364|NCT00778622|O1|Outcome|Glucophage XR in Normal Weight Participants|Normal weight defined as BMI >= 18.5 kg/m^2 and < 24 kg/m^2 .
1015365|NCT00778622|E3|Reported Event|Glucophage XR in Obese Participants|Obese was defined as BMI >= 28 kg/m^2.
1015366|NCT00778622|E2|Reported Event|Glucophage XR in Overweight Participants|Overweight defined as BMI >= 24 kg/m^2 and < 28 kg/m^2.
1015370|NCT00778336|B3|Baseline|Hemodialysis Access|Patients with thrombosed hemodialysis access treated with a midlength AngioJet catheter.
1015371|NCT00778336|B2|Baseline|Deep Vein Thrombosis|Patients with deep vein thrombosis treated with a midlength AngioJet catheter.
1015372|NCT00778336|B1|Baseline|Limb Ischemia|Patients with limb ischemia treated with a midlength AngioJet catheter.
1015373|NCT00778336|P4|Participant Flow|Other Thrombotic Conditions|Patients with a thrombotic Condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access treated with a midlength AngioJet catheter.
1015374|NCT00778336|P3|Participant Flow|Hemodialysis Access|Patients with thrombosed hemodialysis access treated with a midlength AngioJet catheter.
1015375|NCT00778336|P2|Participant Flow|Deep Vein Thrombosis|Patients with deep vein thrombosis treated with a midlength AngioJet catheter.
1015376|NCT00778336|P1|Participant Flow|Limb Ischemia|Patients with limb ischemia treated with a midlength AngioJet catheter.
1015377|NCT00778336|O4|Outcome|Other Thrombotic Conditions|Patients treated with a midlength Angiojet catheter for thrombotic conditions other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access
1015378|NCT00778336|O3|Outcome|Hemodialysis Access|Patients treated with a midlength Angiojet catheter for thrombosed hemodialysis access sites
1015379|NCT00778336|O2|Outcome|Deep Vein Thrombosis|Patients treated with a midlength Angiojet catheter for deep vein thrombosis
1015380|NCT00778336|O1|Outcome|Limb Ischemia|Patients treated with a midlength Angiojet catheter for limb ischemia
1015381|NCT00778336|O4|Outcome|Other Thrombotic Conditions|Patients treated with a midlength Angiojet catheter for thrombotic conditions other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access
1015382|NCT00778336|O3|Outcome|Hemodialysis Access|Patients treated with a midlength Angiojet catheter for thrombosed hemodialysis access sites
1015383|NCT00778336|O2|Outcome|Deep Vein Thrombosis|Patients treated with a midlength Angiojet catheter for deep vein thrombosis
1015384|NCT00778336|O1|Outcome|Limb Ischemia|Patients treated with a midlength Angiojet catheter for limb ischemia
1015385|NCT00778336|O4|Outcome|Other Thrombotic Conditions|Patients treated with a midlength Angiojet catheter for thrombotic conditions other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access
1015386|NCT00778336|O3|Outcome|Hemodialysis Access|Patients treated with a midlength Angiojet catheter for thrombosed hemodialysis access sites
1015387|NCT00778336|O2|Outcome|Deep Vein Thrombosis|Patients treated with a midlength Angiojet catheter for deep vein thrombosis
1015388|NCT00778336|O1|Outcome|Limb Ischemia|Patients treated with a midlength Angiojet catheter for limb ischemia
1015389|NCT00778336|E4|Reported Event|Other Thrombotic Conditions|Patients with a thrombotic Condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access treated with a midlength AngioJet catheter.
1015390|NCT00778336|E3|Reported Event|Hemodialysis Access|Patients with thrombosed hemodialysis access treated with a midlength AngioJet catheter.
1015391|NCT00778336|E2|Reported Event|Deep Vein Thrombosis|Patients with deep vein thrombosis treated with a midlength AngioJet catheter.
1015392|NCT00778336|E1|Reported Event|Limb Ischemia|Patients with limb ischemia treated with a midlength AngioJet catheter.
1015393|NCT00778310|B3|Baseline|Total|Total of all reporting groups
1015394|NCT00778310|B2|Baseline|Children|These were participants between the age of 3- 17 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.
1015395|NCT00778310|B1|Baseline|Adults|These were participants between the age of 21-25 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.
1015396|NCT00778310|P2|Participant Flow|Children|These were participants between the age of 3- 17 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.
1015397|NCT00778310|P1|Participant Flow|Adults|These were participants between the age of 21-25 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.
1015398|NCT00778310|O4|Outcome|Children Placebo Condition|This is the BOLD signal data on the Placebo day scan.
1015399|NCT00778310|O3|Outcome|Children Drug Condition|This is the BOLD signal data on the Concerta day scan.
1015400|NCT00778310|O2|Outcome|Adults Placebo Condition|This is the BOLD signal data on the Placebo day scan.
1015401|NCT00778310|O1|Outcome|Adults Drug Condition|This is the BOLD signal data on the Concerta day scan.
1015402|NCT00778310|E2|Reported Event|Children|These were participants between the age of 3- 17 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.
1015403|NCT00778310|E1|Reported Event|Adults|These were participants between the age of 21-25 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.
1015404|NCT00778258|B10|Baseline|Total|Total of all reporting groups
1015405|NCT00778258|B9|Baseline|Non-Randomized – Tolerant to Baked and Non-baked Milk|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group passed all OFCs without a reaction were not randomized. Participants were instructed to include full milk products to their diet for 3 months, followed by complete dietary milk elimination for 1 month. Participants were then re-challenged to unheated milk. Following successful challenge, participants were placed on an unrestricted milk diet and brought in for re-evaluation at 6 months. If participants were not successful in their challenge to unheated milk, they had baked milk products progressively re-introduced to their diets.
1015406|NCT00778258|B8|Baseline|Non-Randomized – Reacted to Muffin|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to muffin and were not randomized. Participants were instructed to avoid milk and return for re-evaluation with laboratory tests at 12 and 24 months and baked milk challenge at 36 months
1023902|NCT00760578|O2|Outcome|MSDC-0160 220 mg|MSDC-0160 220 mg once daily
1015407|NCT00778258|B7|Baseline|Not Randomized – Comparison|Participants in this group fulfilled inclusion criteria into the study but refused participation. These participants were used as comparison to other groups
1015408|NCT00778258|B6|Baseline|Maintenance- Reacted to Non-baked Milk|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
1015409|NCT00778258|B5|Baseline|Maintenance - Reacted to Rice Pudding|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
1015410|NCT00778258|B4|Baseline|Maintenance - Reacted to Pizza|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 12 months (maintenance) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
1015411|NCT00778258|B3|Baseline|Dose Escalation - Reacted to Non-baked Milk|At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to non-baked milk and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
1015412|NCT00778258|B2|Baseline|Dose Escalation - Reacted to Rice Pudding|At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
1015413|NCT00778258|B1|Baseline|Dose Escalation - Reacted to Pizza|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 6 months (dose escalation) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
1015414|NCT00778258|P9|Participant Flow|Non-Randomized – Tolerant to Baked and Non-baked Milk|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group passed all OFCs without a reaction were not randomized. Participants were instructed to include full milk products to their diet for 3 months, followed by complete dietary milk elimination for 1 month. Participants were then re-challenged to unheated milk. Following successful challenge, participants were placed on an unrestricted milk diet and brought in for re-evaluation at 6 months. If participants were not successful in their challenge to unheated milk, they had baked milk products progressively re-introduced to their diets.
1015415|NCT00778258|P8|Participant Flow|Non-Randomized – Reacted to Muffin|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to muffin and were not randomized. Participants were instructed to avoid milk and return for re-evaluation with laboratory tests at 12 and 24 months and baked milk challenge at 36 months
1015416|NCT00778258|P7|Participant Flow|Not Randomized – Comparison|Participants in this group fulfilled inclusion criteria into the study but refused participation. These participants were used as comparison to other groups
1015417|NCT00778258|P6|Participant Flow|Maintenance- Reacted to Non-baked Milk|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
1015418|NCT00778258|P5|Participant Flow|Maintenance - Reacted to Rice Pudding|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
1015419|NCT00778258|P4|Participant Flow|Maintenance - Reacted to Pizza|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 12 months (maintenance) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
1015420|NCT00778258|P3|Participant Flow|Dose Escalation - Reacted to Non-baked Milk|At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to non-baked milk and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
1015421|NCT00778258|P2|Participant Flow|Dose Escalation - Reacted to Rice Pudding|At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to return for re-evaluation every 6 months (dose escalation) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
1015422|NCT00778258|P1|Participant Flow|Dose Escalation - Reacted to Pizza|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 6 months (dose escalation) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
1015423|NCT00778258|O3|Outcome|Reacted to Muffin|This group included participants who were in baseline group 1
1015424|NCT00778258|O2|Outcome|Comparison Group|This group comprised of participants who did not want to participate in OFCs and were advised to avoid milk-based food products for the remainder of the study
1015425|NCT00778258|O1|Outcome|Active|This group included participants who were in baseline groups 2 through 4.
1015426|NCT00778258|O3|Outcome|Reacted to Muffin|This group included participants who were in baseline group 1
1015427|NCT00778258|O2|Outcome|Comparison Group|This group comprised of participants who did not want to participate in OFCs and were advised to avoid milk-based food products for the remainder of the study
1015428|NCT00778258|O1|Outcome|Active|This group included participants who were in baseline groups 2 through 4.
1015429|NCT00778258|O3|Outcome|Reacted to Muffin|This group included participants who were in baseline group 1
1015430|NCT00778258|O2|Outcome|Comparison Group|This group comprised of participants who did not want to participate in OFCs and were advised to avoid milk-based food products for the remainder of the study
1015431|NCT00778258|O1|Outcome|Active|This group included participants who were in baseline groups 2 through 4.
1015432|NCT00778258|O5|Outcome|Group 5 = Passed All|Participants in this group passed all oral food challenges without an allergic reaction during their baseline visit
1015433|NCT00778258|O4|Outcome|Group 4 = Milk|Participants in this group experienced an allergic reaction to drinking unheated milk during their baseline oral food challenge
1015434|NCT00778258|O3|Outcome|Group 3 = Rice Pudding|Participants in this group experienced an allergic reaction to eating rice pudding during their baseline oral food challenge
1015435|NCT00778258|O2|Outcome|Group 2 = Pizza|Participants in this group experienced an allergic reaction to eating pizza during their baseline oral food challenge
1015436|NCT00778258|O1|Outcome|Group 1 = Muffin|Participants in this group experienced an allergic reaction to eating a muffin during their baseline oral food challenge
1015437|NCT00778258|O3|Outcome|Group 4 - Milk|Participants in this group experienced a reaction to unheated milk during their baseline visit oral food challenge
1015438|NCT00778258|O2|Outcome|Group 3 – Rice Pudding|Participants in this group experienced a reaction to rice pudding during their baseline visit oral food challenge
1015439|NCT00778258|O1|Outcome|Group 2 – Pizza|Participants in this group experienced a reaction to pizza during their baseline visit oral food challenge
1015440|NCT00778258|O5|Outcome|Group 5 = Passed All|Participants in this group passed all oral food challenges without an allergic reaction during their baseline visit
1015441|NCT00778258|O4|Outcome|Group 4 = Milk|Participants in this group experienced an allergic reaction to drinking unheated milk during their baseline oral food challenge
1015442|NCT00778258|O3|Outcome|Group 3 = Rice Pudding|Participants in this group experienced an allergic reaction to eating rice pudding during their baseline oral food challenge
1015443|NCT00778258|O2|Outcome|Group 2 = Pizza|Participants in this group experienced an allergic reaction to eating pizza during their baseline oral food challenge
1015444|NCT00778258|O1|Outcome|Group 1 = Muffin|Participants in this group experienced an allergic reaction to eating a muffin during their baseline oral food challenge
1015445|NCT00778258|O5|Outcome|Group 5 = Passed All|Participants in this group passed all oral food challenges without an allergic reaction during their baseline visit
1015446|NCT00778258|O4|Outcome|Group 4 = Milk|Participants in this group experienced an allergic reaction to drinking unheated milk during their baseline oral food challenge
1015447|NCT00778258|O3|Outcome|Group 3 = Rice Pudding|Participants in this group experienced an allergic reaction to eating rice pudding during their baseline oral food challenge
1015448|NCT00778258|O2|Outcome|Group 2 = Pizza|Participants in this group experienced an allergic reaction to eating pizza during their baseline oral food challenge
1015763|NCT00777179|E1|Reported Event|Vandetanib|Vandetanib 300 mg, orally, once daily
1015449|NCT00778258|O1|Outcome|Group 1 = Muffin|Participants in this group experienced an allergic reaction to eating a muffin during their baseline oral food challenge
1015450|NCT00778258|O5|Outcome|Group 5 = Passed All|Participants in this group passed all oral food challenges without an allergic reaction during their baseline visit
1015451|NCT00778258|O4|Outcome|Group 4 = Milk|Participants in this group experienced an allergic reaction to drinking unheated milk during their baseline oral food challenge
1015452|NCT00778258|O3|Outcome|Group 3 = Rice Pudding|Participants in this group experienced an allergic reaction to eating rice pudding during their baseline oral food challenge
1015453|NCT00778258|O2|Outcome|Group 2 = Pizza|Participants in this group experienced an allergic reaction to eating pizza during their baseline oral food challenge
1015454|NCT00778258|O1|Outcome|Group 1 = Muffin|Participants in this group experienced an allergic reaction to eating a muffin during their baseline oral food challenge
1015455|NCT00778258|O3|Outcome|Group 4 - Milk|Participants in this group experienced a reaction to unheated milk during their baseline visit oral food challenge
1015456|NCT00778258|O2|Outcome|Group 3 – Rice Pudding|Participants in this group experienced a reaction to rice pudding during their baseline visit oral food challenge
1015457|NCT00778258|O1|Outcome|Group 2 – Pizza|Participants in this group experienced a reaction to pizza during their baseline visit oral food challenge
1015458|NCT00778258|O2|Outcome|Maintenance Group|Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 12 months.[Maintenance arm].
1015459|NCT00778258|O1|Outcome|Dose-Escalation Group|Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 6 months.[Dose Escalation arm].
1015460|NCT00778258|O2|Outcome|Maintenance Group|Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 12 months.[Maintenance arm].
1015461|NCT00778258|O1|Outcome|Dose-Escalation Group|Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 6 months.[Dose Escalation arm].
1015462|NCT00778258|O2|Outcome|Maintenance Group|Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 12 months.
1015463|NCT00778258|O1|Outcome|Dose-Escalation Group|Participants in groups 2-4 were randomized to re-try less denatured milk protein food items every 6 months.
1015464|NCT00778258|E9|Reported Event|Non-Randomized - Tolerant to Baked and Non-baked Milk|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group passed all OFCs without a reaction were not randomized. Participants were instructed to include full milk products to their diet for 3 months, followed by complete dietary milk elimination for 1 month. Participants were then re-challenged to unheated milk. Following successful challenge, participants were placed on an unrestricted milk diet and brought in for re-evaluation at 6 months. If participants were not successful in their challenge to unheated milk, they had baked milk products progressively re-introduced to their diets.
1015465|NCT00778258|E8|Reported Event|Non-Randomized - Reacted to Muffin|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to muffin and were not randomized. Participants were instructed to avoid milk and return for re-evaluation with laboratory tests at 12 and 24 months and baked milk challenge at 36 months
1015466|NCT00778258|E7|Reported Event|Not Randomized - Comparison|Participants in this group fulfilled inclusion criteria into the study but refused participation. These participants were used as comparison to other groups
1015467|NCT00778258|E6|Reported Event|Maintenance - Reacted to Non-baked Milk|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
1015468|NCT00778258|E5|Reported Event|Maintenance - Reacted to Rice Pudding|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to continue eating the food at the same level of milk denaturalization and come in for OFCs every 12 months. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
1015469|NCT00778258|E4|Reported Event|Maintenance - Reacted to Pizza|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 12 months (maintenance) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
1015470|NCT00778258|E3|Reported Event|Dose Escalation - Reacted to Non-baked Milk|At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to non-baked milk and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
1015542|NCT00777946|O1|Outcome|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
1015471|NCT00778258|E2|Reported Event|Dose Escalation - Reacted to Rice Pudding|At baseline, participants performed an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to rice pudding and were then randomized to re-try less denatured milk protein food items every 6 months (dose escalation). Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
1015472|NCT00778258|E1|Reported Event|Dose Escalation - Reacted to Pizza|At baseline, participants had an oral food challenge (OFC). They were given food containing milk protein denatured through baking. Participants were given progressively increasing quantities of less denatured milk protein foods until they had an allergic reaction. The food they experienced a reaction to was their baseline group. Participants in this group reacted to pizza and were then randomized to return for re-evaluation every 6 months (dose escalation) to determine whether they might progress to ingesting higher amounts of baked milk protein. Participants in this group received instructions for intake of baked milk foods at home and were followed up to 46 months.
1015473|NCT00778167|B4|Baseline|Total|Total of all reporting groups
1015474|NCT00778167|B3|Baseline|Cohort 3|Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 15 mg/kg IV in 21-day cycles.
1015475|NCT00778167|B2|Baseline|Cohort 2|Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 5 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
1015476|NCT00778167|B1|Baseline|Cohort 1|Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 6 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
1015477|NCT00778167|P3|Participant Flow|Cohort 3|Cohort 3: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 15 mg/kg IV in 21-day cycles.
1015478|NCT00778167|P2|Participant Flow|Cohort 2|Cohort 2: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 5 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
1015479|NCT00778167|P1|Participant Flow|Cohort 1|Cohort 1: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 6 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
1015480|NCT00778167|O3|Outcome|Cohort 3|Cohort 3: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 15 mg/kg IV in 21-day cycles.
1015481|NCT00778167|O2|Outcome|Cohort 2|Cohort 2: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 5 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
1015482|NCT00778167|O1|Outcome|Cohort 1|Cohort 1: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 6 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
1015483|NCT00778167|E3|Reported Event|Cohort 3|Cohort 3: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 15 mg/kg IV in 21-day cycles.
1015484|NCT00778167|E2|Reported Event|Cohort 2|Cohort 2: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 5 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
1015485|NCT00778167|E1|Reported Event|Cohort 1|Cohort 1: Patients received oral erlotinib hydrochloride 150 mg once daily with cixutumumab 6 mg/kg IV on days 1, 8, 15, and 22 in 28-day cycles.
1015486|NCT00778102|B3|Baseline|Total|Total of all reporting groups
1015487|NCT00778102|B2|Baseline|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
1015488|NCT00778102|B1|Baseline|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
1015489|NCT00778102|P2|Participant Flow|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus oxaliplatin, irinotecan, leucovorin, and 5-FU (FOLFOXIRI). Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
1015490|NCT00778102|P1|Participant Flow|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX-6). Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 milligrams per kilogram (mg/kg) via intravenous (IV) infusion; oxaliplatin 85 milligrams per meter-squared (mg/m^2) via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, progressive disease (PD), unacceptable toxicity, or participant refusal.
1015491|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
1015543|NCT00777946|O3|Outcome|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
1015764|NCT00777153|B4|Baseline|Total|Total of all reporting groups
1015492|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
1015493|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
1015494|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
1015495|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
1015496|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
1015497|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
1015498|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
1015499|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
1015500|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
1015501|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
1015502|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
1015503|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
1015765|NCT00777153|B3|Baseline|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
1015504|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
1015505|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
1015506|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
1015507|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
1015508|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
1015509|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
1015510|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
1015511|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
1015512|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
1015513|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
1015514|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
1015515|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
1015832|NCT00777023|E2|Reported Event|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
1015516|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
1015517|NCT00778102|O2|Outcome|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
1015518|NCT00778102|O1|Outcome|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
1015519|NCT00778102|E2|Reported Event|Bevacizumab + FOLFOXIRI|Participants received a chemotherapy regimen of bevacizumab plus FOLFOXIRI. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; irinotecan 165 mg/m^2 via IV infusion; leucovorin 200 mg/m^2 via IV infusion; and 5-FU 3200 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants were to discontinue either irinotecan, oxaliplatin, or both. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
1015520|NCT00778102|E1|Reported Event|Bevacizumab + mFOLFOX-6|Participants received a chemotherapy regimen of bevacizumab plus mFOLFOX-6. Each drug was administered on Day 1 of each 2-week cycle. Dosing was as follows: bevacizumab 5 mg/kg via IV infusion; oxaliplatin 85 mg/m^2 via IV infusion; leucovorin 400 mg/m^2 via IV infusion; 5-FU 400 mg/m^2 via IV bolus; and 5-FU 2400 mg/m^2 via continuous 46-hour IV infusion. Following completion of 12 cycles, participants could discontinue oxaliplatin and continue with bevacizumab, leucovorin, and 5-FU. Treatment was continued until resectability, PD, unacceptable toxicity, or participant refusal.
1015521|NCT00777946|B4|Baseline|Total|Total of all reporting groups
1015522|NCT00777946|B3|Baseline|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
1015523|NCT00777946|B2|Baseline|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
1015524|NCT00777946|B1|Baseline|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
1015525|NCT00777946|P3|Participant Flow|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
1015526|NCT00777946|P2|Participant Flow|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
1015527|NCT00777946|P1|Participant Flow|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
1015528|NCT00777946|O3|Outcome|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
1015529|NCT00777946|O2|Outcome|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
1015530|NCT00777946|O1|Outcome|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
1015531|NCT00777946|O3|Outcome|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
1015532|NCT00777946|O2|Outcome|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
1015533|NCT00777946|O1|Outcome|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
1015534|NCT00777946|O3|Outcome|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
1015535|NCT00777946|O2|Outcome|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
1015536|NCT00777946|O1|Outcome|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
1015537|NCT00777946|O3|Outcome|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
1015538|NCT00777946|O2|Outcome|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
1015539|NCT00777946|O1|Outcome|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
1015540|NCT00777946|O3|Outcome|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
1015541|NCT00777946|O2|Outcome|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
1015606|NCT00777790|E1|Reported Event|Menactra® Group|Subjects that received Menactra® vaccine in Study MTA02
1015544|NCT00777946|O2|Outcome|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
1015545|NCT00777946|O1|Outcome|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
1015546|NCT00777946|E3|Reported Event|Aliskiren 300 mg|Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
1015547|NCT00777946|E2|Reported Event|Aliskiren 300 mg/Amlodipine 5 mg|Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
1015548|NCT00777946|E1|Reported Event|Aliskiren 300 mg/Amlodipine 10 mg|Participants received 1 Aliskiren/Amlodipine 300/10mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
1015549|NCT00777855|B1|Baseline|Entire Study Population|Includes participants randomized to receive warfarin alone then warfarin+rifampin, and those randomized to receive warfarin+rifampin then warfarin alone in the crossover design
1015550|NCT00777855|P2|Participant Flow|Warfarin+Rifampin First, Then Warfarin Alone|In a randomized, single-dose, two-period, crossover design, 5 participants received a 30-minute IV infusion of 600mg rifampin immediately followed by warfarin 7.5mg po; after a minimum of 14 days, participants received warfarin alone 7.5mg po.
1015551|NCT00777855|P1|Participant Flow|Warfarin First, Then Warfarin+Rifampin|In a randomized, single-dose, two-period, crossover design, 5 participants received warfarin alone 7.5mg po; after a minimum of 14 days, participants received a 30-minute IV infusion of 600mg rifampin immediately followed by warfarin 7.5mg po.
1015552|NCT00777855|O2|Outcome|Warfarin Plus Rifampin|warfarin plus rifampin : warfarin 7.5mg po x 1 immediately following rifampin 600mg IV x 1
1015553|NCT00777855|O1|Outcome|Warfarin|warfarin : warfarin 7.5mg po x 1
1015554|NCT00777855|O2|Outcome|Warfarin Plus Rifampin|warfarin plus rifampin : warfarin 7.5mg po x 1 immediately following rifampin 600mg IV x 1
1015555|NCT00777855|O1|Outcome|Warfarin|warfarin : warfarin 7.5mg po x 1
1015556|NCT00777855|O2|Outcome|Warfarin Plus Rifampin|warfarin plus rifampin : warfarin 7.5mg po x 1 immediately following rifampin 600mg IV x 1
1015557|NCT00777855|O1|Outcome|Warfarin|warfarin : warfarin 7.5mg po x 1
1015558|NCT00777855|E1|Reported Event|Entire Study Population|Each of 10 participants received both study treatments, in randomly assigned sequence, separated by a minimum of 14 days
1015559|NCT00777803|B3|Baseline|Total|Total of all reporting groups
1015560|NCT00777803|B2|Baseline|OnabotulinumtoxinA (Vistabel®)|
1015561|NCT00777803|B1|Baseline|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
1015562|NCT00777803|P2|Participant Flow|OnabotulinumtoxinA (Vistabel®)|
1015563|NCT00777803|P1|Participant Flow|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
1015564|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
1015565|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
1015566|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
1015567|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
1015568|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
1015569|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
1015570|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
1015571|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
1015572|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
1015573|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
1015574|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
1015575|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
1015576|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
1015577|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
1015578|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
1015579|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
1015580|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
1015581|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
1015582|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
1015583|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
1015584|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
1015585|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
1015586|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
1015587|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
1015588|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
1015589|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
1015590|NCT00777803|O2|Outcome|OnabotulinumtoxinA (Vistabel®)|
1015591|NCT00777803|O1|Outcome|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
1015592|NCT00777803|E2|Reported Event|OnabotulinumtoxinA (Vistabel®)|
1015593|NCT00777803|E1|Reported Event|IncobotulinumtoxinA (Xeomin®/Bocouture®)|
1015594|NCT00777790|B4|Baseline|Total|Total of all reporting groups
1015595|NCT00777790|B3|Baseline|Control Group|Meningococcal vaccine-naïve subjects
1015596|NCT00777790|B2|Baseline|Menomune® Group|Subjects that received Menomune® vaccine in Study MTA02
1015597|NCT00777790|B1|Baseline|Menactra® Group|Subjects that received Menactra® vaccine in Study MTA02
1015598|NCT00777790|P3|Participant Flow|Control Group|Meningococcal vaccine-naïve subjects
1015599|NCT00777790|P2|Participant Flow|Menomune® Group|Subjects that received Menomune® vaccine in Study MTA02
1015600|NCT00777790|P1|Participant Flow|Menactra® Group|Subjects that received Menactra® vaccine in Study MTA02
1015601|NCT00777790|O3|Outcome|Control Group|Meningococcal vaccine-naïve subjects
1015602|NCT00777790|O2|Outcome|Menomune® Group|Subjects that received Menomune® vaccine in Study MTA02
1015603|NCT00777790|O1|Outcome|Menactra® Group|Subjects that received Menactra® vaccine in Study MTA02
1015604|NCT00777790|E3|Reported Event|Control Group|Meningococcal vaccine-naïve subjects
1015605|NCT00777790|E2|Reported Event|Menomune® Group|Subjects that received Menomune® vaccine in Study MTA02
1015607|NCT00777764|B3|Baseline|Total|Total of all reporting groups
1015608|NCT00777764|B2|Baseline|Allergic Asthma Participants|"Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:100,000 and 1:10,000 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in saline solution."
1015609|NCT00777764|B1|Baseline|Healthy Subjects|"Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:1000, 1:100 and 1:10 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in sterile water for injection (SWFI)."
1015610|NCT00777764|P2|Participant Flow|Allergic Asthma Participants|"Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:100,000 and 1:10,000 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in saline solution."
1015611|NCT00777764|P1|Participant Flow|Healthy Subjects|"Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:1000, 1:100 and 1:10 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in sterile water for injection (SWFI)."
1015612|NCT00777764|O1|Outcome|Patients With Allergic Asthma|
1015613|NCT00777764|O1|Outcome|Healthy Subjects|
1015614|NCT00777764|O2|Outcome|Allergic Asthma Participants|"Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:100,000 and 1:10,000 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in saline solution."
1015615|NCT00777764|O1|Outcome|Healthy Subjects|"Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:1000, 1:100 and 1:10 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in sterile water for injection (SWFI)."
1015616|NCT00777764|O2|Outcome|Allergic Asthma Participants|"Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:100,000 and 1:10,000 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in saline solution."
1015617|NCT00777764|O1|Outcome|Healthy Subjects|"Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:1000, 1:100 and 1:10 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in sterile water for injection (SWFI)."
1015618|NCT00777764|E2|Reported Event|Allergic Asthma Participants|"Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:100,000 and 1:10,000 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in saline solution."
1015675|NCT00776659|O1|Outcome|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
1015676|NCT00776659|O1|Outcome|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
1015619|NCT00777764|E1|Reported Event|Healthy Subjects|"Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:1000, 1:100 and 1:10 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings.~Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.~Dilutions of omalizumab and its excipients were made in sterile water for injection (SWFI)."
1015620|NCT00777634|B3|Baseline|Total|Total of all reporting groups
1015621|NCT00777634|B2|Baseline|Without BED|Individuals who do not meet criteria for binge eating disorder.
1015622|NCT00777634|B1|Baseline|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
1015623|NCT00777634|P2|Participant Flow|Without BED|Individuals who do not meet criteria for binge eating disorder.
1015624|NCT00777634|P1|Participant Flow|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
1015625|NCT00777634|O2|Outcome|Without BED|Individuals who do not meet criteria for binge eating disorder.
1015626|NCT00777634|O1|Outcome|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
1015627|NCT00777634|O2|Outcome|Without BED|Individuals who do not meet criteria for binge eating disorder.
1015628|NCT00777634|O1|Outcome|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
1015629|NCT00777634|O2|Outcome|Without BED|Individuals who do not meet criteria for binge eating disorder.
1015630|NCT00777634|O1|Outcome|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
1015631|NCT00777634|O2|Outcome|Without BED|Individuals who do not meet criteria for binge eating disorder.
1015632|NCT00777634|O1|Outcome|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
1015633|NCT00777634|O2|Outcome|Without BED|Individuals who do not meet criteria for binge eating disorder.
1015634|NCT00777634|O1|Outcome|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
1015635|NCT00777634|O2|Outcome|Without BED|Individuals who do not meet criteria for binge eating disorder.
1015636|NCT00777634|O1|Outcome|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
1015637|NCT00777634|E2|Reported Event|Without BED|Individuals who do not meet criteria for binge eating disorder.
1015638|NCT00777634|E1|Reported Event|Binge Eating Disorder (BED)|Individuals who meet criteria for binge eating disorder.
1015639|NCT00777608|B3|Baseline|Total|Total of all reporting groups
1015640|NCT00777608|B2|Baseline|Placebo|Participants were randomized to placebo for 84 days
1015641|NCT00777608|B1|Baseline|Donepezil 5-10 mg|Participants were randomized to donepezil for 84 days
1015642|NCT00777608|P2|Participant Flow|Placebo|Participants were randomized to placebo for 84 days
1015643|NCT00777608|P1|Participant Flow|Donepezil 5-10 mg|Participants were randomized to donepezil for 84 days
1015644|NCT00777608|O2|Outcome|Placebo|Participants were randomized to placebo for 84 days
1015645|NCT00777608|O1|Outcome|Donepezil 5-10 mg|Participants were randomized to donepezil for 84 days
1015646|NCT00777608|O2|Outcome|Placebo|Participants were randomized to placebo for 84 days
1015647|NCT00777608|O1|Outcome|Donepezil 5-10 mg|Participants were randomized to donepezil for 84 days
1015648|NCT00777608|O2|Outcome|Placebo|Participants were randomized to placebo for 84 days
1015649|NCT00777608|O1|Outcome|Donepezil 5-10 mg|Participants were randomized to donepezil for 84 days
1015650|NCT00777608|E2|Reported Event|Placebo|Participants were randomized to placebo for 84 days
1015651|NCT00777608|E1|Reported Event|Donezepil 5-10 mg|Participants were randomized to donepezil for 84 days
1015652|NCT00777556|B1|Baseline|DR-104|One tablet for emergency contraception
1015653|NCT00777556|P1|Participant Flow|DR-104|One tablet for emergency contraception
1015654|NCT00777556|O1|Outcome|DR-104|One tablet for emergency contraception
1015655|NCT00777556|O1|Outcome|DR-104|One tablet for emergency contraception
1015656|NCT00777556|O1|Outcome|DR-104|One tablet for emergency contraception
1015657|NCT00777556|O1|Outcome|DR-104|One tablet for emergency contraception
1015658|NCT00777556|E1|Reported Event|DR-104|One tablet for emergency contraception
1015659|NCT00777335|B3|Baseline|Total|Total of all reporting groups
1015660|NCT00777335|B2|Baseline|Panobinostat Oral|
1015661|NCT00777335|B1|Baseline|Panobinostat Intra-venous (i.v.)|
1015662|NCT00777335|P2|Participant Flow|Panobinostat Oral|
1015663|NCT00777335|P1|Participant Flow|Panobinostat Intra-venous (i.v.)|
1015664|NCT00777335|O2|Outcome|Panobinostat Oral|
1015665|NCT00777335|O1|Outcome|Panobinostat Intra-venous (i.v.)|
1015666|NCT00777335|O2|Outcome|Panobinostat Oral|
1015667|NCT00777335|O1|Outcome|Panobinostat Intra-venous (i.v.)|
1015668|NCT00777335|E2|Reported Event|Panobinostat Oral|
1015669|NCT00777335|E1|Reported Event|Panobinostat Intra-venous (i.v.)|
1015670|NCT00776659|B1|Baseline|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
1015671|NCT00776659|P1|Participant Flow|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
1015672|NCT00776659|O1|Outcome|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
1015673|NCT00776659|O1|Outcome|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
1015674|NCT00776659|O1|Outcome|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
1015677|NCT00776659|O1|Outcome|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
1015678|NCT00776659|O1|Outcome|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
1015679|NCT00776659|E1|Reported Event|Exemestane|Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred.
1015680|NCT00776594|B3|Baseline|Total|Total of all reporting groups
1015681|NCT00776594|B2|Baseline|Androgen Deprivation Therapy Alone|"Androgen Deprivation Therapy Alone~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months"
1015682|NCT00776594|B1|Baseline|Androgen Deprivation Therapy Plus Bevacizumab|"Androgen Deprivation Therapy Plus Bevacizumab~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months~bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months"
1015683|NCT00776594|P2|Participant Flow|Androgen Deprivation Therapy Alone|"Androgen Deprivation Therapy Alone~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months"
1015684|NCT00776594|P1|Participant Flow|Androgen Deprivation Therapy Plus Bevacizumab|"Androgen Deprivation Therapy Plus Bevacizumab~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months~bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months"
1015685|NCT00776594|O2|Outcome|Leptin in Patients Treated With ADT Alone|Leptin in patients with sample available treated with ADT alone
1015686|NCT00776594|O1|Outcome|Leptin Level in Patients Treated With ADT+Bev|Leptin level in patients with sample available treated with ADT+bev
1015687|NCT00776594|O2|Outcome|Group 2|"Androgen Deprivation Therapy Alone~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months"
1015688|NCT00776594|O1|Outcome|Group 1|"Androgen Deprivation Therapy Plus Bevacizumab~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months~bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months"
1015689|NCT00776594|O2|Outcome|Group 2|"Androgen Deprivation Therapy Alone~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months"
1015690|NCT00776594|O1|Outcome|Group 1|"Androgen Deprivation Therapy Plus Bevacizumab~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months~bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months"
1015691|NCT00776594|O2|Outcome|Group 2|"Androgen Deprivation Therapy Alone~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months"
1015692|NCT00776594|O1|Outcome|Group 1|"Androgen Deprivation Therapy Plus Bevacizumab~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months~bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months"
1015693|NCT00776594|E2|Reported Event|Group 1|"Androgen Deprivation Therapy Plus Bevacizumab~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months~bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months"
1015694|NCT00776594|E1|Reported Event|Group 2|"Androgen Deprivation Therapy Alone~Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months~bicalutamide: 50mg orally daily for 6 months"
1015695|NCT00776555|B3|Baseline|Total|Total of all reporting groups
1015696|NCT00776555|B2|Baseline|ADDERALL XR First|Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention
1015697|NCT00776555|B1|Baseline|Vyvanse First|Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention
1015698|NCT00776555|P2|Participant Flow|ADDERALL XR First|Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention
1015699|NCT00776555|P1|Participant Flow|Vyvanse First|Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention
1015700|NCT00776555|O2|Outcome|ADDERALL XR First|Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention
1015701|NCT00776555|O1|Outcome|Vyvanse First|Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention
1015749|NCT00777179|B1|Baseline|Vandetanib|Vandetanib 300 mg, orally, once daily
1015750|NCT00777179|P2|Participant Flow|Placebo|Matching Placebo
1015702|NCT00776555|O2|Outcome|ADDERALL XR First|Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention
1015703|NCT00776555|O1|Outcome|Vyvanse First|Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention
1015704|NCT00776555|O2|Outcome|ADDERALL XR First|Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention
1015705|NCT00776555|O1|Outcome|Vyvanse First|Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention
1015706|NCT00776555|E2|Reported Event|ADDERALL XR First|Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention
1015707|NCT00776555|E1|Reported Event|Vyvanse First|Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention
1015708|NCT00777257|B4|Baseline|Total|Total of all reporting groups
1015709|NCT00777257|B3|Baseline|Menactra® + Placebo Vaccines Day 0|Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
1015710|NCT00777257|B2|Baseline|Tdap + Menactra® Vaccines Day 0|Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
1015711|NCT00777257|B1|Baseline|Tdap + Placebo Vaccines Day 0|Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
1015712|NCT00777257|P3|Participant Flow|Menactra® + Placebo Vaccines Day 0|Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
1015713|NCT00777257|P2|Participant Flow|Tdap + Menactra® Vaccines Day 0|Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
1015714|NCT00777257|P1|Participant Flow|Tdap + Placebo Vaccines Day 0|Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
1015715|NCT00777257|O3|Outcome|Menactra® + Placebo Vaccines Day 0|Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
1015716|NCT00777257|O2|Outcome|Tdap + Menactra® Vaccines Day 0|Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
1015717|NCT00777257|O1|Outcome|Tdap + Placebo Vaccines Day 0|Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
1015718|NCT00777257|O3|Outcome|Menactra® + Placebo Vaccines Day 0|Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
1015719|NCT00777257|O2|Outcome|Tdap + Menactra® Vaccines Day 0|Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
1015720|NCT00777257|O1|Outcome|Tdap + Placebo Vaccines Day 0|Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
1015721|NCT00777257|O3|Outcome|Menactra® + Placebo Vaccines Day 0|Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
1015722|NCT00777257|O2|Outcome|Tdap + Menactra® Vaccines Day 0|Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
1015723|NCT00777257|O1|Outcome|Tdap + Placebo Vaccines Day 0|Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
1015724|NCT00777257|O3|Outcome|Menactra® + Placebo Vaccines Day 0|Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
1015725|NCT00777257|O2|Outcome|Tdap + Menactra® Vaccines Day 0|Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
1015726|NCT00777257|O1|Outcome|Tdap + Placebo Vaccines Day 0|Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
1015727|NCT00777257|E3|Reported Event|Menactra® + Placebo Vaccines Day 0|Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
1015728|NCT00777257|E2|Reported Event|Tdap + Menactra® Vaccines Day 0|Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
1015729|NCT00777257|E1|Reported Event|Tdap + Placebo Vaccines Day 0|Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
1015730|NCT00777205|B3|Baseline|Total|Total of all reporting groups
1015731|NCT00777205|B2|Baseline|Telephone-based Peer Support|"Participants used an IVR telephone system for mutual peer support over a 6-month period of time. Additionally, participants will received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.~Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
1015732|NCT00777205|B1|Baseline|Enhanced Usual Care|"Patients in the enhanced usual care arm received their usual mental health care, a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
1015751|NCT00777179|P1|Participant Flow|Vandetanib|Vandetanib 300 mg, orally, once daily
1015752|NCT00777179|O2|Outcome|Placebo|Matching Placebo
1015753|NCT00777179|O1|Outcome|Vandetanib|Vandetanib 300 mg, orally, once daily
1015754|NCT00777179|O2|Outcome|Placebo|Matching Placebo
1015755|NCT00777179|O1|Outcome|Vandetanib|Vandetanib 300 mg, orally, once daily
1015733|NCT00777205|P2|Participant Flow|Telephone-based Peer Support|"Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
1015734|NCT00777205|P1|Participant Flow|Enhanced Usual Care|Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
1015735|NCT00777205|O2|Outcome|Telephone-based Peer Support|"Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
1015736|NCT00777205|O1|Outcome|Enhanced Usual Care|Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
1015737|NCT00777205|O2|Outcome|Telephone-based Peer Support|"Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
1015738|NCT00777205|O1|Outcome|Enhanced Usual Care|Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
1015739|NCT00777205|O2|Outcome|Telephone-based Peer Support|"Participants used an IVR telephone system for mutual peer support over a 6-month period of time. Additionally, participants will received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.~Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
1015740|NCT00777205|O1|Outcome|Enhanced Usual Care|"Patients in the enhanced usual care arm received their usual mental health care, a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
1015741|NCT00777205|O2|Outcome|Telephone-based Peer Support|"Participants used an IVR telephone system for mutual peer support over a 6-month period of time. Additionally, participants will received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.~Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
1015742|NCT00777205|O1|Outcome|Enhanced Usual Care|"Patients in the enhanced usual care arm received their usual mental health care, a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
1015743|NCT00777205|O2|Outcome|Telephone-based Peer Support|"Participants used an IVR telephone system for mutual peer support over a 6-month period of time. Additionally, participants will received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.~Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
1015744|NCT00777205|O1|Outcome|Enhanced Usual Care|"Patients in the enhanced usual care arm received their usual mental health care, a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
1015745|NCT00777205|E2|Reported Event|Telephone-based Peer Support|"Telephone-based peer support: Patients received a) a peer-support manual that outlines self-management and recovery principles and provides peer discussion topics and b) access to a specialized telephone platform that permits free calls to their partners, ready access to mental health staff for back-up and advice on being effective partners, and recorded tips on depression management. They were asked to call their peer partner at least once a week for 24 weeks.~Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips."
1015746|NCT00777205|E1|Reported Event|Enhanced Usual Care|Enhanced Usual Care: Patients received a copy of the Depression Helpbook by Wayne Katon and bi-weekly study mailings with depression management tips.
1015747|NCT00777179|B3|Baseline|Total|Total of all reporting groups
1015748|NCT00777179|B2|Baseline|Placebo|Matching Placebo
1015766|NCT00777153|B2|Baseline|Cediranib 20mg + Lomustine 110mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
1015767|NCT00777153|B1|Baseline|Cediranib 30mg|Cediranib 30mg/Day
1015768|NCT00777153|P3|Participant Flow|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
1015769|NCT00777153|P2|Participant Flow|Cediranib 20mg + Lomustine 110mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
1015770|NCT00777153|P1|Participant Flow|Cediranib 30mg|Cediranib 30mg/Day
1015771|NCT00777153|O3|Outcome|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
1015772|NCT00777153|O2|Outcome|Cediranib 20mg + Lomustine 119mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
1015773|NCT00777153|O1|Outcome|Cediranib 30mg|Cediranib 30mg/Day
1015774|NCT00777153|O3|Outcome|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
1015775|NCT00777153|O2|Outcome|Cediranib 20mg + Lomustine 110mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
1015776|NCT00777153|O1|Outcome|Cediranib 30mg|Cediranib 30mg/Day
1015777|NCT00777153|O3|Outcome|Lomustine 100mg|Lomustine 110mg/m2/Day + Placebo cediranib
1015778|NCT00777153|O2|Outcome|Cediranib 20mg + Lomustine 100mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
1015779|NCT00777153|O1|Outcome|Cediranib 30mg|Cediranib 30mg/Day
1015780|NCT00777153|O3|Outcome|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
1015781|NCT00777153|O2|Outcome|Cediranib 20mg + Lomustine 110mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
1015782|NCT00777153|O1|Outcome|Cediranib 30mg|Cediranib 30mg/Day
1015783|NCT00777153|O3|Outcome|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
1015784|NCT00777153|O2|Outcome|Cediranib 20mg + Lomustine 110mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
1015785|NCT00777153|O1|Outcome|Cediranib 30mg|Cediranib 30mg/Day
1015786|NCT00777153|O3|Outcome|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
1015787|NCT00777153|O2|Outcome|Cediranib 20mg+ Lomustine 110mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
1015788|NCT00777153|O1|Outcome|Cediranib 30mg|Cediranib 30mg/Day
1015789|NCT00777153|E3|Reported Event|Lomustine 110mg|Lomustine 110mg/m2/Day + Placebo cediranib
1015790|NCT00777153|E2|Reported Event|Cediranib 20mg + Lomustine 110mg|Cediranib 20mg/Day + Lomustine 110mg/m2/Day
1015791|NCT00777153|E1|Reported Event|Cediranib 30mg|Cediranib 30mg/Day
1015792|NCT00777062|B3|Baseline|Total|Total of all reporting groups
1015793|NCT00777062|B2|Baseline|Placebo|Placebo injection, 380 mg injection at the start of weeks 2 and 6.
1015794|NCT00777062|B1|Baseline|Vivitrol|VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6
1015795|NCT00777062|P2|Participant Flow|Placebo|Placebo injection, 380 mg injection at the start of weeks 2 and 6.
1015796|NCT00777062|P1|Participant Flow|Vivitrol|VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6
1015797|NCT00777062|O2|Outcome|Placebo|Placebo injection, 380 mg injection at the start of weeks 2 and 6.
1015798|NCT00777062|O1|Outcome|Vivitrol|VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6
1015799|NCT00777062|O2|Outcome|Placebo|Placebo injection, 380 mg injection at the start of weeks 2 and 6.
1015800|NCT00777062|O1|Outcome|Vivitrol|VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6
1015801|NCT00777062|E2|Reported Event|Placebo|Placebo injection, 380 mg injection at the start of weeks 2 and 6.
1015802|NCT00777062|E1|Reported Event|Vivitrol|VIVITROL (Naltrexone extended-release injectable suspension), 380 mg injection at the start of weeks 2 and 6
1015803|NCT00777049|B3|Baseline|Total|Total of all reporting groups
1015804|NCT00777049|B2|Baseline|ER- and PgR- (Arm II)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
1015805|NCT00777049|B1|Baseline|ER+ and/or PgR+ (Arm I)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
1015806|NCT00777049|P2|Participant Flow|ER- and PgR- (Arm II)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
1015807|NCT00777049|P1|Participant Flow|ER+ and/or PgR+ (Arm I)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
1015808|NCT00777049|O2|Outcome|ER- and PgR- (Arm II)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
1015809|NCT00777049|O1|Outcome|ER+ and/or PgR+ (Arm I)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
1015810|NCT00777049|E2|Reported Event|ER- and PgR- (Arm II)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
1015811|NCT00777049|E1|Reported Event|ER+ and/or PgR+ (Arm I)|Panobinostat - LBH589: hard gelatine capsule - 5mg and 20mg
1015812|NCT00777023|B4|Baseline|Total|Total of all reporting groups
1015813|NCT00777023|B3|Baseline|Sugar Pill|Placebo 1200 mg or 1800 mg
1015814|NCT00777023|B2|Baseline|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
1015815|NCT00777023|B1|Baseline|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
1015816|NCT00777023|P3|Participant Flow|Sugar Pill|Placebo 1200 mg or 1800 mg
1015817|NCT00777023|P2|Participant Flow|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
1015818|NCT00777023|P1|Participant Flow|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
1015819|NCT00777023|O3|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
1015820|NCT00777023|O2|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
1015821|NCT00777023|O1|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
1015822|NCT00777023|O3|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
1015823|NCT00777023|O2|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
1015824|NCT00777023|O1|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
1015825|NCT00777023|O3|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
1015826|NCT00777023|O2|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
1015827|NCT00777023|O1|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
1015828|NCT00777023|O3|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
1015829|NCT00777023|O2|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
1015830|NCT00777023|O1|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
1015831|NCT00777023|E3|Reported Event|Sugar Pill|Placebo 1200 mg or 1800 mg
1015833|NCT00777023|E1|Reported Event|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
1015834|NCT00776997|B1|Baseline|LINX System|All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
1015835|NCT00776997|P1|Participant Flow|LINX System|All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
1015836|NCT00776997|O1|Outcome|LINX System|All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
1015837|NCT00776997|O1|Outcome|LINX System|All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
1015838|NCT00776997|O1|Outcome|LINX System|All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
1015839|NCT00776997|O1|Outcome|LINX System|All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
1015840|NCT00776997|E1|Reported Event|LINX System|All subjects are treated with the LINX System during a laparoscopic surgical procedure. Subjects serve as their own control. Baseline measurements are compared to post-implant measurements.
1015841|NCT00776984|B3|Baseline|Total|Total of all reporting groups
1015842|NCT00776984|B2|Baseline|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015843|NCT00776984|B1|Baseline|Placebo|Patients treated with matching placebo
1015844|NCT00776984|P2|Participant Flow|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015845|NCT00776984|P1|Participant Flow|Placebo|Patients treated with matching placebo
1015846|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015847|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
1015848|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015849|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
1015850|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015851|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
1015852|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015853|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
1015854|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015855|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
1015856|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015857|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
1015858|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015859|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
1015860|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015861|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
1015862|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015863|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
1015864|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015865|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
1015866|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015867|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
1015868|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015869|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
1015870|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015871|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
1015872|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015873|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
1015874|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015875|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
1015876|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015877|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
1015878|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015879|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
1015880|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015881|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
1015882|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015883|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
1015884|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015885|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
1015886|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015887|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
1015888|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015889|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
1015890|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015891|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
1015892|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015893|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
1015894|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015895|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
1015896|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015897|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
1015898|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015899|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
1015900|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015901|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
1015902|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015903|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
1015904|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015905|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
1015906|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015907|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
1015908|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015909|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
1015910|NCT00776984|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015911|NCT00776984|O1|Outcome|Placebo|Patients treated with matching placebo
1015912|NCT00776984|E2|Reported Event|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1015913|NCT00776984|E1|Reported Event|Placebo|Patients treated with matching placebo
1015914|NCT00776919|B5|Baseline|Total|Total of all reporting groups
1015915|NCT00776919|B4|Baseline|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015916|NCT00776919|B3|Baseline|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015917|NCT00776919|B2|Baseline|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015918|NCT00776919|B1|Baseline|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015919|NCT00776919|P4|Participant Flow|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015920|NCT00776919|P3|Participant Flow|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015921|NCT00776919|P2|Participant Flow|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015922|NCT00776919|P1|Participant Flow|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015923|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015924|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015925|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015926|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015927|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015928|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015929|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015930|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015931|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015932|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015933|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1016001|NCT00776295|O1|Outcome|p53 Vaccination|Dendritic cell p53 vaccination
1015934|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015935|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015936|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015937|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015938|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015939|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015940|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015941|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015942|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015943|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015944|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015945|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015946|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015947|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015948|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015949|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015950|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015951|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015952|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015953|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015954|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015955|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015956|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015957|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015958|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015959|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015960|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015961|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015962|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1016002|NCT00776295|E1|Reported Event|Biological/Vaccine|Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expaned T-lymphocytes
1015963|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015964|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015965|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015966|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015967|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015968|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015969|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015970|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015971|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015972|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015973|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015974|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015975|NCT00776919|O4|Outcome|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015976|NCT00776919|O3|Outcome|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015977|NCT00776919|O2|Outcome|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015978|NCT00776919|O1|Outcome|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015979|NCT00776919|E4|Reported Event|Vehicle Gel|Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015980|NCT00776919|E3|Reported Event|BPO Gel|Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015981|NCT00776919|E2|Reported Event|Clindamycin Gel|Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015982|NCT00776919|E1|Reported Event|Duac Low-dose (LD) Gel|Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
1015983|NCT00776789|B3|Baseline|Total|Total of all reporting groups
1015984|NCT00776789|B2|Baseline|Control Group|baby will be kept by the mothers side and not given skin to skin contact
1015985|NCT00776789|B1|Baseline|Skin to Skin Contact|Babies in this arm will be given skin to skin contact for at least 2 hours after birth
1015986|NCT00776789|P2|Participant Flow|Control Group|baby will be kept by the mothers side and not given skin to skin contact
1015987|NCT00776789|P1|Participant Flow|Skin to Skin Contact|Babies in this arm will be given skin to skin contact for at least 2 hours after birth
1015988|NCT00776789|O2|Outcome|Control Group|baby will be kept by the mothers side and not given skin to skin contact
1015989|NCT00776789|O1|Outcome|Skin to Skin Contact|Babies in this arm will be given skin to skin contact for at least 2 hours after birth
1015990|NCT00776789|O2|Outcome|Control Group|Babies will be kept by the mothers side and not given skin to skin contact
1015991|NCT00776789|O1|Outcome|Skin to Skin Contact|Babies in this arm will be given skin to skin contact for at least 2 hours after birth
1015992|NCT00776789|O2|Outcome|Control Group|baby will be kept by the mothers side and not given skin to skin contact
1015993|NCT00776789|O1|Outcome|Skin to Skin Contact|Babies in this arm will be given skin to skin contact for at least 2 hours after birth
1015994|NCT00776789|O2|Outcome|Control Group|Baby will be kept by the mothers side and not given skin to skin contact
1015995|NCT00776789|O1|Outcome|Skin to Skin Contact|Babies in this arm will be given skin to skin contact for at least 2 hours after birth
1015996|NCT00776789|E2|Reported Event|Control Group|baby will be kept by the mothers side and not given skin to skin contact
1015997|NCT00776789|E1|Reported Event|Skin to Skin Contact|Babies in this arm will be given skin to skin contact for at least 2 hours after birth
1015998|NCT00776295|B1|Baseline|p53 Vaccination|Dendritic cell p53 vaccination
1015999|NCT00776295|P1|Participant Flow|p53 Vaccination|Dendritic cell p53 vaccination
1016000|NCT00776295|O1|Outcome|p53 Vaccination|Dendritic cell p53 vaccination
1016004|NCT00776230|B3|Baseline|IC51 Cohort 3|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~24 months after filling;
1016005|NCT00776230|B2|Baseline|IC51 Cohort 2|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~18 months after filling;
1016006|NCT00776230|B1|Baseline|IC51 Cohort 1|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~12 months after filling;
1016007|NCT00776230|P3|Participant Flow|IC51 Cohort 3|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~24 months after filling;
1016008|NCT00776230|P2|Participant Flow|IC51 Cohort 2|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~18 months after filling;
1016009|NCT00776230|P1|Participant Flow|IC51 Cohort 1|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~12 months after filling;
1016010|NCT00776230|O3|Outcome|IC51 Cohort 3|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~24 months after filling;
1016011|NCT00776230|O2|Outcome|IC51 Cohort 2|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~18 months after filling;
1016012|NCT00776230|O1|Outcome|IC51 Cohort 1|vaccinations with IC51 6 mcg i.m. on Day 0 and Day 28; batch age: ~12 months after filling;
1016013|NCT00776230|E3|Reported Event|IC51 Cohort 3|
1016014|NCT00776230|E2|Reported Event|IC51 Cohort 2|
1016015|NCT00776230|E1|Reported Event|IC51 Cohort 1|
1016016|NCT00776100|B3|Baseline|Total|Total of all reporting groups
1016017|NCT00776100|B2|Baseline|Arm II (Radiation Therapy)|Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
1016018|NCT00776100|B1|Baseline|Arm I (No Radiation)|Patients undergo observation for 6 weeks.
1016019|NCT00776100|P2|Participant Flow|Arm II (Radiation Therapy)|Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
1016020|NCT00776100|P1|Participant Flow|Arm I (No Radiation)|Patients undergo observation for 6 weeks.
1016021|NCT00776100|O2|Outcome|Arm II (Radiation Therapy)|Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
1016022|NCT00776100|O1|Outcome|Arm I (No Radiation)|Patients undergo observation for 6 weeks.
1016023|NCT00776100|O2|Outcome|Arm II (Radiation Therapy)|Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
1016024|NCT00776100|O1|Outcome|Arm I (No Radiation)|Patients undergo observation for 6 weeks.
1016025|NCT00776100|O2|Outcome|Arm II (Radiation Therapy)|Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
1016026|NCT00776100|O1|Outcome|Arm I (No Radiation)|Patients undergo observation for 6 weeks.
1016027|NCT00776100|O2|Outcome|Arm II (Radiation Therapy)|Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
1016028|NCT00776100|O1|Outcome|Arm I (No Radiation)|Patients undergo observation for 6 weeks.
1016029|NCT00776100|O2|Outcome|Arm II (Radiation Therapy)|Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
1016030|NCT00776100|O1|Outcome|Arm I (No Radiation)|Patients undergo observation for 6 weeks.
1016031|NCT00776100|O2|Outcome|Arm II (Radiation Therapy)|Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
1016032|NCT00776100|O1|Outcome|Arm I (No Radiation)|Patients undergo observation for 6 weeks.
1016033|NCT00776100|E2|Reported Event|Arm II (Radiation Therapy)|Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
1016034|NCT00776100|E1|Reported Event|Arm I (No Radiation)|Patients undergo observation for 6 weeks.
1016035|NCT00776009|B7|Baseline|Total|Total of all reporting groups
1016036|NCT00776009|B6|Baseline|Placebo First, Then Focalin XR 30 mg, Then Focalin XR 20 mg|Period 1: Placebo orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days.
1016037|NCT00776009|B5|Baseline|Focalin XR 20 mg First, Then Placebo, Then Focalin XR 30 mg|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 2: Placebo orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days.
1016038|NCT00776009|B4|Baseline|Placebo First, Then Focalin XR 20 mg, Then Focalin XR 30 mg|Period 1: Placebo orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days.
1016039|NCT00776009|B3|Baseline|Focalin XR 30 mg First, Then Focalin XR 20 mg, Then Placebo|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 3: Placebo orally once a day for 7 days .
1016040|NCT00776009|B2|Baseline|Focalin XR 30 mg First, Then Placebo, Then Focalin XR 20 mg|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 2: Placebo orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days.
1016041|NCT00776009|B1|Baseline|Focalin XR 20 mg First, Then Focalin XR 30 mg, Then Placebo|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 3: Placebo orally once a day for 7 days.
1016042|NCT00776009|P6|Participant Flow|Placebo First, Then Focalin XR 30 mg, Then Focalin XR 20 mg|Period 1: Placebo orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days.
1016043|NCT00776009|P5|Participant Flow|Focalin XR 20 mg First, Then Placebo, Then Focalin XR 30 mg|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 2: Placebo orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days.
1016044|NCT00776009|P4|Participant Flow|Placebo First, Then Focalin XR 20 mg, Then Focalin XR 30 mg|Period 1: Placebo orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days.
1016045|NCT00776009|P3|Participant Flow|Focalin XR 30 mg First, Then Focalin XR 20 mg, Then Placebo|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 3: Placebo orally once a day for 7 days .
1016046|NCT00776009|P2|Participant Flow|Focalin XR 30 mg First, Then Placebo, Then Focalin XR 20 mg|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 2: Placebo orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days.
1016047|NCT00776009|P1|Participant Flow|Focalin XR 20 mg First, Then Focalin XR 30 mg, Then Placebo|Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 3: Placebo orally once a day for 7 days.
1016048|NCT00776009|O3|Outcome|Placebo|Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence.
1016049|NCT00776009|O2|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days for all participants regardless of sequence.
1016050|NCT00776009|O1|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days for all participants regardless of sequence.
1016051|NCT00776009|O3|Outcome|Placebo|Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence.
1016052|NCT00776009|O2|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days for all participants regardless of sequence.
1016053|NCT00776009|O1|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days for all participants regardless of sequence.
1016054|NCT00776009|O3|Outcome|Placebo|Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence.
1016055|NCT00776009|O2|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days for all participants regardless of sequence.
1016056|NCT00776009|O1|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days for all participants regardless of sequence.
1016057|NCT00776009|O3|Outcome|Placebo|Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence.
1016058|NCT00776009|O2|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days for all participants regardless of sequence.
1016059|NCT00776009|O1|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days for all participants regardless of sequence.
1016060|NCT00776009|O3|Outcome|Placebo|Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence.
1016061|NCT00776009|O2|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days for all participants regardless of sequence.
1016062|NCT00776009|O1|Outcome|Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days for all participants regardless of sequence.
1016063|NCT00776009|E3|Reported Event|Placebo|Summary of the one week treatment on Placebo orally once a day for 7 days for all participants regardless of sequence.
1016064|NCT00776009|E2|Reported Event|Dex-Methylphenidate Hydrochloride (Focalin XR) 20 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days for all participants regardless of sequence.
1016065|NCT00776009|E1|Reported Event|Dex-Methylphenidate Hydrochloride (Focalin XR) 30 mg|Summary of the one week treatment on Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days for all participants regardless of sequence.
1016066|NCT00775983|B3|Baseline|Total|Total of all reporting groups
1016067|NCT00775983|B2|Baseline|Dilapan-S|For patients between 14 0/7 and 15 6/7 weeks' gestation on the day of the abortion, 2-3 Dilapan-S were inserted. For patients between 16 0/7 and 18 0/7 weeks' gestation, 2-5 Dilapan-S were inserted. One medium laminaria was placed along with the Dilapan-S because of the theory that the laminaria would facilitate the removal of Dilapan-S before the abortion. Patients then waited four to six hours for their abortion.
1016068|NCT00775983|B1|Baseline|Laminaria|laminaria placed for cervical dilation; usual standard of care in study clinic. The number of laminaria placed was calculated based on a predetermined formula: weeks gestational age minus ten.
1016069|NCT00775983|P2|Participant Flow|Dilapan-S|For patients between 14 0/7 and 15 6/7 weeks' gestation on the day of the abortion, 2-3 Dilapan-S were inserted. For patients between 16 0/7 and 18 0/7 weeks' gestation, 2-5 Dilapan-S were inserted. One medium laminaria was placed along with the Dilapan-S because of the theory that the laminaria would facilitate the removal of Dilapan-S before the abortion. Patients then waited four to six hours for their abortion.
1016070|NCT00775983|P1|Participant Flow|Laminaria|laminaria placed for cervical dilation; usual standard of care in study clinic. The number of laminaria placed was calculated based on a predetermined formula: weeks gestational age minus ten.
1016071|NCT00775983|O2|Outcome|Dilapan-S|For patients between 14 0/7 and 15 6/7 weeks' gestation on the day of the abortion, 2-3 Dilapan-S were inserted. For patients between 16 0/7 and 18 0/7 weeks' gestation, 2-5 Dilapan-S were inserted. One medium laminaria was placed along with the Dilapan-S because of the theory that the laminaria would facilitate the removal of Dilapan-S before the abortion. Patients then waited four to six hours for their abortion.
1016072|NCT00775983|O1|Outcome|Overnight Laminaria|Overnight laminaria placed for cervical dilation; usual standard of care in study clinic. The number of laminaria placed was calculated based on a predetermined formula: weeks gestational age minus ten.
1016073|NCT00775983|O2|Outcome|Dilapan-S|For patients between 14 0/7 and 15 6/7 weeks' gestation on the day of the abortion, 2-3 Dilapan-S were inserted. For patients between 16 0/7 and 18 0/7 weeks' gestation, 2-5 Dilapan-S were inserted. One medium laminaria was placed along with the Dilapan-S because of the theory that the laminaria would facilitate the removal of Dilapan-S before the abortion. Patients then waited four to six hours for their abortion.
1016074|NCT00775983|O1|Outcome|Overnight Laminaria|Overnight laminaria placed for cervical dilation; usual standard of care in study clinic. The number of laminaria placed was calculated based on a predetermined formula: weeks gestational age minus ten.
1016075|NCT00775983|E2|Reported Event|Dilapan-S|For patients between 14 0/7 and 15 6/7 weeks' gestation on the day of the abortion, 2-3 Dilapan-S were inserted. For patients between 16 0/7 and 18 0/7 weeks' gestation, 2-5 Dilapan-S were inserted. One medium laminaria was placed along with the Dilapan-S because of the theory that the laminaria would facilitate the removal of Dilapan-S before the abortion. Patients then waited four to six hours for their abortion.
1016076|NCT00775983|E1|Reported Event|Laminaria|laminaria placed for cervical dilation; usual standard of care in study clinic. The number of laminaria placed was calculated based on a predetermined formula: weeks gestational age minus ten.
1016077|NCT00775944|B5|Baseline|Total|Total of all reporting groups
1016078|NCT00775944|B4|Baseline|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
1016079|NCT00775944|B3|Baseline|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
1016080|NCT00775944|B2|Baseline|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
1016081|NCT00775944|B1|Baseline|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
1016082|NCT00775944|P4|Participant Flow|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
1016083|NCT00775944|P3|Participant Flow|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
1016084|NCT00775944|P2|Participant Flow|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
1016085|NCT00775944|P1|Participant Flow|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
1016086|NCT00775944|O4|Outcome|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
1016087|NCT00775944|O3|Outcome|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
1016088|NCT00775944|O2|Outcome|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
1016089|NCT00775944|O1|Outcome|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
1016090|NCT00775944|O4|Outcome|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
1016091|NCT00775944|O3|Outcome|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
1016092|NCT00775944|O2|Outcome|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
1016093|NCT00775944|O1|Outcome|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
1016094|NCT00775944|O4|Outcome|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
1016095|NCT00775944|O3|Outcome|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
1016096|NCT00775944|O2|Outcome|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
1016097|NCT00775944|O1|Outcome|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
1016098|NCT00775944|O4|Outcome|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
1016099|NCT00775944|O3|Outcome|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
1016100|NCT00775944|O2|Outcome|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
1016101|NCT00775944|O1|Outcome|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
1016102|NCT00775944|O4|Outcome|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
1016103|NCT00775944|O3|Outcome|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
1016104|NCT00775944|O2|Outcome|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
1016105|NCT00775944|O1|Outcome|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
1016106|NCT00775944|E4|Reported Event|Proactive Support & Offer of NRT|Proactive telephone support and offer of voucher for cost free NRT
1016107|NCT00775944|E3|Reported Event|Standard Support & Offer of NRT|Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
1016108|NCT00775944|E2|Reported Event|Proactive Telephone Support|Proactive support & advice to obtain nicotine addiction treatment
1016109|NCT00775944|E1|Reported Event|Standard Support|Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment
1016110|NCT00775671|B3|Baseline|Total|Total of all reporting groups
1016111|NCT00775671|B2|Baseline|Metoprolol|Metoprolol ER 100mg by motuh daily for 12 weeks.
1016112|NCT00775671|B1|Baseline|Nebivolol|Nebivolol 5mg by mouth daily for 12 weeks.
1016113|NCT00775671|P2|Participant Flow|Metoprolol|Metoprolol ER 100mg by motuh daily for 12 weeks.
1016114|NCT00775671|P1|Participant Flow|Nebivolol|Nebivolol 5mg by mouth daily for 12 weeks.
1016115|NCT00775671|O2|Outcome|Metoprolol|Metoprolol ER 100mg by motuh daily for 12 weeks.
1016116|NCT00775671|O1|Outcome|Nebivolol|Nebivolol 5mg by mouth daily for 12 weeks.
1016117|NCT00775671|O2|Outcome|Metoprolol|Metoprolol ER 100mg by motuh daily for 12 weeks.
1016118|NCT00775671|O1|Outcome|Nebivolol|Nebivolol 5mg by mouth daily for 12 weeks.
1016119|NCT00775671|E2|Reported Event|Metoprolol|Metoprolol ER 100mg by motuh daily for 12 weeks.
1016120|NCT00775671|E1|Reported Event|Nebivolol|Nebivolol 5mg by mouth daily for 12 weeks.
1016121|NCT00775645|B3|Baseline|Total|Total of all reporting groups
1016122|NCT00775645|B2|Baseline|Arm II (Placebo)|Patients receive oral placebo 3 times daily for 24 weeks
1016123|NCT00775645|B1|Baseline|Arm I (Acetyl-L-carnitine Hydrochloride))|Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks
1016124|NCT00775645|P2|Participant Flow|Arm II (Placebo)|Patients receive oral placebo 3 times daily for 24 weeks
1016125|NCT00775645|P1|Participant Flow|Arm I (Acetyl-L-carnitine Hydrochloride))|Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks
1016126|NCT00775645|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo 3 times daily for 24 weeks
1016127|NCT00775645|O1|Outcome|Arm I (Acetyl-L-carnitine Hydrochloride))|Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks
1016128|NCT00775645|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo 3 times daily for 24 weeks
1016129|NCT00775645|O1|Outcome|Arm I (Acetyl-L-carnitine Hydrochloride))|Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks
1016130|NCT00775645|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo 3 times daily for 24 weeks
1016131|NCT00775645|O1|Outcome|Arm I (Acetyl-L-carnitine Hydrochloride))|Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks
1016132|NCT00775645|E2|Reported Event|Arm II (Placebo)|Patients receive oral placebo 3 times daily for 24 weeks
1016133|NCT00775645|E1|Reported Event|Arm I (Acetyl-L-carnitine Hydrochloride))|Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks
1016134|NCT00775606|B3|Baseline|Total|Total of all reporting groups
1016135|NCT00775606|B2|Baseline|ARM B|Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
1016136|NCT00775606|B1|Baseline|ARM A|Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
1016137|NCT00775606|P2|Participant Flow|ARM B/Efavirenz|Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
1016138|NCT00775606|P1|Participant Flow|ARM A/Lopinavir-ritonavir|Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
1016139|NCT00775606|O2|Outcome|ARM B|Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
1016140|NCT00775606|O1|Outcome|ARM A|Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
1016141|NCT00775606|O2|Outcome|ARM B/Efavirenz|Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
1016142|NCT00775606|O1|Outcome|ARM A/Lopinavir-ritonavir|Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
1016143|NCT00775606|O2|Outcome|ARM B/Efavirenz|Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
1016144|NCT00775606|O1|Outcome|ARM A/Lopinavir-ritonavir|Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
1016145|NCT00775606|E2|Reported Event|ARM B/Efavirenz|Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD
1016146|NCT00775606|E1|Reported Event|ARM A/Lopinavir-ritonavir|Subjects randomized to Arm a will initiate Lopinavir 400 mg/ritonavir 100 mg BID + emtricitabine 200 mg/tenofovir 300 mg QD
1016147|NCT00775593|B1|Baseline|Study Group|Patients will receive one course of low-dose Clofarabine in combination with Temsirolimus (CloTor regimen) for remission induction. Those who achieve morphologic complete remission (CR) and morphologic complete remission with incomplete blood count recovery (CRi) will receive maintenance treatment with Temsirolimus monthly for 12 months, or until relapse. Those who achieve a partial remission (PR) will receive one additional course of CloTor and, if a CR/CRi is obtained, maintenance treatment with Temsirolimus as above. Patients not achieving CR or CRi after one or two induction courses will be discontinued from the study.
1016148|NCT00775593|P1|Participant Flow|Study Group|Patients will receive one course of low-dose Clofarabine in combination with Temsirolimus (CloTor regimen) for remission induction. Those who achieve morphologic complete remission (CR) and morphologic complete remission with incomplete blood count recovery (CRi) will receive maintenance treatment with Temsirolimus monthly for 12 months, or until relapse. Those who achieve a partial remission (PR) will receive one additional course of CloTor and, if a CR/CRi is obtained, maintenance treatment with Temsirolimus as above. Patients not achieving CR or CRi after one or two induction courses will be discontinued from the study.
1016149|NCT00775593|O1|Outcome|Study Group|Evaluable patients
1016150|NCT00775593|O1|Outcome|Study Group|Evaluable patients
1016151|NCT00775593|O1|Outcome|Study Group|Evaluable patients
1016152|NCT00775593|O1|Outcome|Study Group|Evaluable patients
1016153|NCT00775593|E1|Reported Event|Study Group|Evaluable patients
1016154|NCT00775528|B1|Baseline|Pancrelipase Delayed-Release Capsules|Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks.
1016155|NCT00775528|P1|Participant Flow|Pancrelipase Delayed-Release Capsules|Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks.
1016156|NCT00775528|O1|Outcome|Pancrelipase Delayed-Release Capsules|Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks.
1016157|NCT00775528|O1|Outcome|Pancrelipase Delayed-Release Capsules|Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks.
1016158|NCT00775528|O1|Outcome|Pancrelipase Delayed-Release Capsules|Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks.
1016159|NCT00775528|O1|Outcome|Pancrelipase Delayed-Release Capsules|Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks.
1023903|NCT00760578|O1|Outcome|MSDC-0160 90 mg|MSDC-0160 90 mg once daily
1016160|NCT00775528|E1|Reported Event|Pancrelipase Delayed-Release Capsules|Target dose of 8000 lipase units/kg/day. This dose was administered in divided doses with meals/snacks.
1016161|NCT00775463|B3|Baseline|Total|Total of all reporting groups
1016162|NCT00775463|B2|Baseline|Treprostinil Diethanolamine|intent to treat population
1016163|NCT00775463|B1|Baseline|Placebo|intent to treat population
1016164|NCT00775463|P2|Participant Flow|Treprostinil Diethanolamine|All subejcts who recieved at least one dose of study drug. One subject in the treprostinil diethanolamine treatment group was randomized, withdrew consent and exited the study prior to taking any study medication and is not included in the analysis summary.
1016165|NCT00775463|P1|Participant Flow|Placebo|All subjects who recieved at least one dose of study drug.
1016166|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
1016167|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
1016168|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
1016169|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
1016170|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
1016171|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
1016172|NCT00775463|O6|Outcome|Treprostinil Diethanolamine- Overall Disease Status Response|Treprostinil diethanolamine intent to treat population
1016173|NCT00775463|O5|Outcome|Placebo- Overall Disease Status Response|Placebo intent to treat population
1016174|NCT00775463|O4|Outcome|Treprostinil Diethanolamine- Raynaud's Phenomenon Response|Treprostinil diethanolamine intent to treat population
1016175|NCT00775463|O3|Outcome|Placebo- Raynaud's Phenomenon Response|Placebo intent to treat population
1016176|NCT00775463|O2|Outcome|Treprostinil Diethanolamine- Digital Ulcer Response|Treprostinil diethanolamine intent to treat population
1016177|NCT00775463|O1|Outcome|Placebo- Digital Ulcer Response|Placebo intent to treat population
1016178|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
1016179|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
1016180|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
1016181|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
1016182|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
1016183|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
1016184|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
1016185|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
1016186|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
1016187|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
1016188|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
1016189|NCT00775463|O1|Outcome|Placebo|placebo intent to treat population
1016190|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
1016191|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
1016192|NCT00775463|O2|Outcome|Treprostinil Diethanolamine|Treprostinil diethanolamine intent to treat population
1016193|NCT00775463|O1|Outcome|Placebo|Placebo intent to treat population
1016194|NCT00775463|E2|Reported Event|Treprostinil Diethanolamine|
1016195|NCT00775463|E1|Reported Event|Placebo|
1016196|NCT00775450|B6|Baseline|Total|Total of all reporting groups
1016197|NCT00775450|B5|Baseline|Group 3: Fluzone HD After Fluzone HD|Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
1016198|NCT00775450|B4|Baseline|Group 2b: Fluzone ID After Fluzone IM|Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
1016199|NCT00775450|B3|Baseline|Group 2a: Fluzone IM After Fluzone IM|Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
1016200|NCT00775450|B2|Baseline|Group 1b: Fluzone IM After Fluzone ID|Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
1016201|NCT00775450|B1|Baseline|Group 1a: Fluzone ID After Fluzone ID|Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
1016202|NCT00775450|P5|Participant Flow|Group 3: Fluzone HD After Fluzone HD|Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
1016203|NCT00775450|P4|Participant Flow|Group 2b: Fluzone ID After Fluzone IM|Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
1016204|NCT00775450|P3|Participant Flow|Group 2a: Fluzone IM After Fluzone IM|Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
1016205|NCT00775450|P2|Participant Flow|Group 1b: Fluzone IM After Fluzone ID|Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
1016206|NCT00775450|P1|Participant Flow|Group 1a: Fluzone ID After Fluzone ID|Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
1016207|NCT00775450|O5|Outcome|Group 3: Fluzone HD After Fluzone HD|Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
1016208|NCT00775450|O4|Outcome|Group 2b: Fluzone ID After Fluzone IM|Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
1016209|NCT00775450|O3|Outcome|Group 2a: Fluzone IM After Fluzone IM|Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
1017761|NCT00772603|P1|Participant Flow|2400mg/Day SPN-804|2400mg of SPN-804O once daily
1016210|NCT00775450|O2|Outcome|Group 1b: Fluzone IM After Fluzone ID|Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
1016211|NCT00775450|O1|Outcome|Group 1a: Fluzone ID After Fluzone ID|Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
1016212|NCT00775450|O5|Outcome|Group 3: Fluzone HD After Fluzone HD|Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
1016213|NCT00775450|O4|Outcome|Group 2b: Fluzone ID After Fluzone IM|Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
1016214|NCT00775450|O3|Outcome|Group 2a: Fluzone IM After Fluzone IM|Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
1016215|NCT00775450|O2|Outcome|Group 1b: Fluzone IM After Fluzone ID|Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
1016216|NCT00775450|O1|Outcome|Group 1a: Fluzone ID After Fluzone ID|Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
1016217|NCT00775450|O5|Outcome|Group 3: Fluzone HD After Fluzone HD|Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
1016218|NCT00775450|O4|Outcome|Group 2b: Fluzone ID After Fluzone IM|Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
1016219|NCT00775450|O3|Outcome|Group 2a: Fluzone IM After Fluzone IM|Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
1016220|NCT00775450|O2|Outcome|Group 1b: Fluzone IM After Fluzone ID|Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
1016221|NCT00775450|O1|Outcome|Group 1a: Fluzone ID After Fluzone ID|Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
1016222|NCT00775450|O5|Outcome|Group 3: Fluzone HD After Fluzone HD|Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
1016223|NCT00775450|O4|Outcome|Group 2b: Fluzone ID After Fluzone IM|Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
1016224|NCT00775450|O3|Outcome|Group 2a: Fluzone IM After Fluzone IM|Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
1016225|NCT00775450|O2|Outcome|Group 1b: Fluzone IM After Fluzone ID|Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
1016226|NCT00775450|O1|Outcome|Group 1a: Fluzone ID After Fluzone ID|Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
1016227|NCT00775450|E5|Reported Event|Group 3: Fluzone HD After Fluzone HD|Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)
1016228|NCT00775450|E4|Reported Event|Group 2b: Fluzone ID After Fluzone IM|Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)
1016229|NCT00775450|E3|Reported Event|Group 2a: Fluzone IM After Fluzone IM|Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)
1016230|NCT00775450|E2|Reported Event|Group 1b: Fluzone IM After Fluzone ID|Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)
1016231|NCT00775450|E1|Reported Event|Group 1a: Fluzone ID After Fluzone ID|Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)
1016232|NCT00775437|B1|Baseline|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016233|NCT00775437|P1|Participant Flow|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016234|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016235|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016310|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
1016381|NCT00774995|B4|Baseline|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1017762|NCT00772603|O3|Outcome|Placebo|Placebo given once daily.
1016236|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016237|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016238|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016239|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016240|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016241|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016242|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016243|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016244|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016245|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016246|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016247|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016248|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016249|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016332|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
1023904|NCT00760578|O4|Outcome|Placebo|Microcrystaline cellulose once daily
1016250|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016251|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016252|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016253|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016254|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016255|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016256|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016257|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016258|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016259|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016260|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016261|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016262|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016263|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016438|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
1023905|NCT00760578|O3|Outcome|Pioglitazone|Pioglitazone 45 mg once daily
1016264|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016265|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016266|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016267|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016268|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016269|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016270|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016271|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016272|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016273|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016274|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016275|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016276|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016277|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016439|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
1016278|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016279|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016280|NCT00775437|O1|Outcome|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016281|NCT00775437|E1|Reported Event|Adalimumab|Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.
1016282|NCT00775411|B1|Baseline|700 µg Dexamethasone + Ranibizumab|700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
1016283|NCT00775411|P1|Participant Flow|700 µg Dexamethasone + Ranibizumab|700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
1016284|NCT00775411|O1|Outcome|700 µg Dexamethasone + Ranibizumab|700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
1016285|NCT00775411|O1|Outcome|700 µg Dexamethasone + Ranibizumab|700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
1016286|NCT00775411|O1|Outcome|700 µg Dexamethasone + Ranibizumab|700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
1016287|NCT00775411|E1|Reported Event|700 µg Dexamethasone + Ranibizumab|700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
1016288|NCT00775346|B1|Baseline|Polysomnography (PSG) Subjects|Subjects who have been prescribed with needing a Polysomnography (PSG) will be enrolled into the study.
1016289|NCT00775346|P1|Participant Flow|Polysomnography (PSG) Subjects|Subjects who have been prescribed with needing a Polysomnography (PSG) will be enrolled into the study.
1016290|NCT00775346|O1|Outcome|Polysomnography (PSG) Subjects|Subjects who have been prescribed with needing a Polysomnography (PSG) will be enrolled into the study.
1016291|NCT00775346|E1|Reported Event|Polysomnography (PSG) Subjects|Subjects who have been prescribed with needing a Polysomnography (PSG) will be enrolled into the study.
1016292|NCT00775229|B3|Baseline|Total|Total of all reporting groups
1016293|NCT00775229|B2|Baseline|Placebo|"Placebo~Placebo : pill, by mouth, daily"
1016294|NCT00775229|B1|Baseline|Naltrexone|"Naltrexone~Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study"
1016295|NCT00775229|P2|Participant Flow|Placebo|"Placebo~Placebo : pill, by mouth, daily"
1016296|NCT00775229|P1|Participant Flow|Naltrexone|"Naltrexone~Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study"
1016297|NCT00775229|O2|Outcome|Placebo|"Placebo~Placebo : pill, by mouth, daily"
1016298|NCT00775229|O1|Outcome|Naltrexone|"Naltrexone~Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study"
1016299|NCT00775229|O2|Outcome|Placebo|"Placebo~Placebo : pill, by mouth, daily"
1016300|NCT00775229|O1|Outcome|Naltrexone|"Naltrexone~Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study"
1016301|NCT00775229|O2|Outcome|Placebo|"Placebo~Placebo : pill, by mouth, daily"
1016302|NCT00775229|O1|Outcome|Naltrexone|"Naltrexone~Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study"
1016303|NCT00775229|E2|Reported Event|Placebo|"Placebo~Placebo : pill, by mouth, daily"
1016304|NCT00775229|E1|Reported Event|Naltrexone|"Naltrexone~Naltrexone : pill, by mouth, 50mg-150mg/day for the duration of the study"
1016305|NCT00775203|B3|Baseline|Total|Total of all reporting groups
1016306|NCT00775203|B2|Baseline|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
1016307|NCT00775203|B1|Baseline|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
1016308|NCT00775203|P2|Participant Flow|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
1016309|NCT00775203|P1|Participant Flow|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
1016311|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
1016312|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
1016313|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
1016314|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
1016315|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
1016316|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
1016317|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
1016318|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
1016319|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
1016320|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
1016321|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
1016322|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
1016323|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
1016324|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
1016325|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
1016326|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
1016327|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
1016328|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
1016329|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
1016330|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
1016331|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
1017763|NCT00772603|O2|Outcome|1200mg/Day SPN-804|1200mg SPN-804O given once daily
1016333|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
1016334|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
1016335|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
1016336|NCT00775203|O2|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
1016337|NCT00775203|O1|Outcome|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
1016338|NCT00775203|E2|Reported Event|Placebo|Subjects with Major Depressive Disorder who were randomized to Placebo to match Trazodone Contramid OAD.
1016339|NCT00775203|E1|Reported Event|Trazodone Contramid OAD|Subjects with Major Depressive Disorder who were randomized to Trazodone Contramid OAD. Dose was titrated to each subject optimal dose every 3 to 4 days by 75 mg increments from a starting dose of 150 mg to a maximum daily dose of 375 mg. At each dosing step, if a dose was not well tolerated after 2 days, subjects had the option to decrease to the previous dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.
1016340|NCT00775190|B3|Baseline|Total|Total of all reporting groups
1016341|NCT00775190|B2|Baseline|Trinessa™|Trinessa: generic oral contraceptive
1016342|NCT00775190|B1|Baseline|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
1016343|NCT00775190|P2|Participant Flow|Trinessa™|Trinessa: generic oral contraceptive
1016344|NCT00775190|P1|Participant Flow|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
1016345|NCT00775190|O2|Outcome|Trinessa™|Trinessa: generic oral contraceptive
1016346|NCT00775190|O1|Outcome|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
1016347|NCT00775190|O2|Outcome|Trinessa™|Trinessa: generic oral contraceptive
1016348|NCT00775190|O1|Outcome|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
1016349|NCT00775190|O2|Outcome|Trinessa™|Trinessa: generic oral contraceptive
1016350|NCT00775190|O1|Outcome|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
1016351|NCT00775190|O2|Outcome|Trinessa™|Trinessa: generic oral contraceptive
1016352|NCT00775190|O1|Outcome|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
1016353|NCT00775190|O2|Outcome|Trinessa™|Trinessa: generic oral contraceptive
1016354|NCT00775190|O1|Outcome|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
1016355|NCT00775190|O2|Outcome|Trinessa™|Trinessa: generic oral contraceptive
1016356|NCT00775190|O1|Outcome|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
1016357|NCT00775190|O2|Outcome|Trinessa™|Trinessa: generic oral contraceptive
1016358|NCT00775190|O1|Outcome|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
1016359|NCT00775190|O2|Outcome|Trinessa™|Trinessa: generic oral contraceptive
1016360|NCT00775190|O1|Outcome|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
1016361|NCT00775190|O2|Outcome|Trinessa™|Trinessa: generic oral contraceptive
1016362|NCT00775190|O1|Outcome|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
1016363|NCT00775190|E2|Reported Event|Trinessa™|Trinessa: generic oral contraceptive
1016364|NCT00775190|E1|Reported Event|Ortho Tricyclen™|ortho tricyclen: brand name oral contraceptive
1016365|NCT00775021|B1|Baseline|Total Participants|Total number of participants that completed the study.
1016366|NCT00775021|P2|Participant Flow|Nelfilcon A/Etafilcon A|nelfilcon A contact lens worn first and etafilcon A contact lens second.
1016367|NCT00775021|P1|Participant Flow|Etafilcon A/Nelfilcon A|etafilcon A contact lens worn first and nelfilcon A contact lens worn second
1016368|NCT00775021|O2|Outcome|Nelfilcon A|All subjects that wore nelfilcon A contact lenses and completed the study.
1016369|NCT00775021|O1|Outcome|Etafilcon A|All subjects that wore etafilcon A contact lenses and completed the study.
1016370|NCT00775021|O2|Outcome|Nelfilcon A|All subjects that wore nelfilcon A contact lenses and completed the study.
1016371|NCT00775021|O1|Outcome|Etafilcon A|All subjects that wore etafilcon A contact lenses and completed the study.
1016372|NCT00775021|O2|Outcome|Nelfilcon A|All subjects that wore nelfilcon A contact lenses and completed the study.
1016373|NCT00775021|O1|Outcome|Etafilcon A|All subjects that wore etafilcon A contact lenses and completed the study.
1016374|NCT00775021|O2|Outcome|Nelfilcon A|All subjects that wore nelfilcon A contact lenses and completed the study.
1016375|NCT00775021|O1|Outcome|Etafilcon A|All subjects that wore etafilcon A contact lenses and completed the study.
1016376|NCT00775021|O2|Outcome|Nelfilcon A|All subjects that wore nelfilcon A contact lenses and completed the study.
1016377|NCT00775021|O1|Outcome|Etafilcon A|All subjects that wore etafilcon A contact lenses and completed the study.
1016378|NCT00775021|E2|Reported Event|Nelfilcon A|nelfilcon A contact lenses.
1016379|NCT00775021|E1|Reported Event|Etafilcon A|etafilcon A contact lenses
1016380|NCT00774995|B5|Baseline|Total|Total of all reporting groups
1016440|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
1016382|NCT00774995|B3|Baseline|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016383|NCT00774995|B2|Baseline|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016384|NCT00774995|B1|Baseline|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016385|NCT00774995|P4|Participant Flow|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016386|NCT00774995|P3|Participant Flow|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016387|NCT00774995|P2|Participant Flow|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016388|NCT00774995|P1|Participant Flow|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016389|NCT00774995|O4|Outcome|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016390|NCT00774995|O3|Outcome|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016391|NCT00774995|O2|Outcome|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016392|NCT00774995|O1|Outcome|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016393|NCT00774995|O4|Outcome|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016394|NCT00774995|O3|Outcome|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016395|NCT00774995|O2|Outcome|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016396|NCT00774995|O1|Outcome|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016397|NCT00774995|O4|Outcome|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016398|NCT00774995|O3|Outcome|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016399|NCT00774995|O2|Outcome|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016400|NCT00774995|O1|Outcome|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016401|NCT00774995|O4|Outcome|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016402|NCT00774995|O3|Outcome|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016403|NCT00774995|O2|Outcome|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016404|NCT00774995|O1|Outcome|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016405|NCT00774995|O4|Outcome|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016406|NCT00774995|O3|Outcome|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016407|NCT00774995|O2|Outcome|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016408|NCT00774995|O1|Outcome|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1017764|NCT00772603|O1|Outcome|2400mg/Day SPN-804|2400mg SPN-804O once daily
1016409|NCT00774995|O4|Outcome|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016410|NCT00774995|O3|Outcome|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016411|NCT00774995|O2|Outcome|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016412|NCT00774995|O1|Outcome|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016413|NCT00774995|O4|Outcome|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016414|NCT00774995|O3|Outcome|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016415|NCT00774995|O2|Outcome|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016416|NCT00774995|O1|Outcome|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016417|NCT00774995|O4|Outcome|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016418|NCT00774995|O3|Outcome|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016419|NCT00774995|O2|Outcome|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016420|NCT00774995|O1|Outcome|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016421|NCT00774995|E4|Reported Event|Engerix(3-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016422|NCT00774995|E3|Reported Event|Engerix(4-dose)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016423|NCT00774995|E2|Reported Event|Engerix(3-dose)+HBIg|Subjects who previously received HBV vaccine at 0, 1, 6 months (3 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016424|NCT00774995|E1|Reported Event|Engerix(4-dose)+HepatitisB(HB) Immunoglobulin (Ig)|Subjects who previously received HBV vaccine at 0, 1, 6 and 60 months (4 doses) and HBIg concomitantly at Month 0, and received a challenge dose of HBV vaccine after approximately 20 years (noted as Day 0) in the current study.
1016425|NCT00774930|B3|Baseline|Total|Total of all reporting groups
1016426|NCT00774930|B2|Baseline|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase.
1016427|NCT00774930|B1|Baseline|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase. Intent-to-treat (ITT) population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.
1016428|NCT00774930|P2|Participant Flow|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase.
1016429|NCT00774930|P1|Participant Flow|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the initial open label (IOL) phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the long term open label extension (LTOLE) phase.
1016430|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
1016431|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
1016432|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
1016433|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
1016434|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
1016435|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
1016436|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
1016437|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
1016441|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
1016442|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
1016443|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
1016444|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
1016445|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
1016446|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
1016447|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
1016448|NCT00774930|O2|Outcome|Placebo|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase).
1016449|NCT00774930|O1|Outcome|Lanreotide Autogel (Somatuline Depot) 120 mg|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase).
1016450|NCT00774930|E4|Reported Event|Lanreotide Autogel (Somatuline Depot) 120 mg (LTOLE Phase)|All 57 subjects in the LTOLE phase received further deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (32 and 25 of these subjects received treatment with lanreotide Autogel and placebo, respectively, during the DB phase).
1016451|NCT00774930|E3|Reported Event|Lanreotide Autogel (Somatuline Depot) 120 mg (IOL Phase)|All 101 subjects in the IOL phase received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks (56 and 45 of these subjects received treatment with lanreotide Autogel and placebo, respectively, during the DB phase).
1016452|NCT00774930|E2|Reported Event|Placebo (DB Phase)|Deep s.c. injections of placebo every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase.
1016453|NCT00774930|E1|Reported Event|Lanreotide Autogel (Somatuline Depot) 120 mg (DB Phase)|Deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks (±3 days) for 16 weeks (DB phase). Subjects then received deep s.c. injections of lanreotide Autogel 120 mg every 4 weeks for 32 weeks in the IOL phase and further deep s.c. injections with lanreotide Autogel every 4 weeks in the LTOLE phase.
1016454|NCT00774852|B3|Baseline|Total|Total of all reporting groups
1016455|NCT00774852|B2|Baseline|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
1016456|NCT00774852|B1|Baseline|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
1016457|NCT00774852|P2|Participant Flow|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
1016458|NCT00774852|P1|Participant Flow|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
1016459|NCT00774852|O2|Outcome|Week 24 Complete Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a complete responder at their Week 24 visit discontinued abatacept placebo and switched to overencapsulated azathioprine up to Week 52
1016460|NCT00774852|O1|Outcome|Week 24 Complete Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a complete responder at their Week 24 visit discontinued abatacept and switched to overencapsulated azathioprine placebo up to Week 52
1016461|NCT00774852|O4|Outcome|Week 24 Partial Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a partial responder at their Week 24 visit continued to receive abatacept placebo up to Week 48 and azathioprine up to Week 52
1016462|NCT00774852|O3|Outcome|Week 24 Partial Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a partial responder at their Week 24 visit continued to receive abatacept up to Week 48 and azathioprine up to Week 52
1016463|NCT00774852|O2|Outcome|Week 24 Complete Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a complete responder at their Week 24 visit discontinued abatacept placebo and switched to overencapsulated azathioprine up to Week 52
1016464|NCT00774852|O1|Outcome|Week 24 Complete Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a complete responder at their Week 24 visit discontinued abatacept and switched to overencapsulated azathioprine placebo up to Week 52
1016465|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
1016466|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
1016467|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
1016468|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
1016469|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
1016470|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
1016471|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
1016507|NCT00774800|O4|Outcome|Humulin-R Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humulin-R was delivered before a liquid meal.
1017765|NCT00772603|O3|Outcome|Placebo|Placebo given once daily.
1016472|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
1016473|NCT00774852|O6|Outcome|Week 24 No Response: Placebo|At Week 28 participants assigned to Placebo group who were classified as a non-responder at their Week 24 visit either terminated from the study at Wk 28 or continued to receive abatacept placebo up to Week 48 and azathioprine up to Week 52, at the discretion of the investigators
1016474|NCT00774852|O5|Outcome|Week 24 No Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a non-responder at their Week 24 visit either terminated from the study at Wk 28 or continued to receive abatacept up to Week 48 and azathioprine up to Week 52, at the discretion of the investigators
1016475|NCT00774852|O4|Outcome|Week 24 Partial Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a partial responder at their Week 24 visit continued to receive abatacept placebo up to Week 48 and azathioprine up to Week 52
1016476|NCT00774852|O3|Outcome|Week 24 Partial Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a partial responder at their Week 24 visit continued to receive abatacept up to Week 48 and azathioprine up to Week 52
1016477|NCT00774852|O2|Outcome|Week 24 Complete Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a complete responder at their Week 24 visit discontinued abatacept placebo and switched to overencapsulated azathioprine up to Week 52
1016478|NCT00774852|O1|Outcome|Week 24 Complete Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a complete responder at their Week 24 visit discontinued abatacept and switched to overencapsulated azathioprine placebo up to Week 52
1016479|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
1016480|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
1016481|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
1016482|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
1016483|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
1016831|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
1016484|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
1016485|NCT00774852|O2|Outcome|Week 24 Non-Responder Who Continued Treatment: Placebo|Participants who were in the placebo arm and non-responders at Week 24 who continued participation. If participation continued, participants continued abatacept placebo up to Week 48 and azathioprine up to Week 52
1016486|NCT00774852|O1|Outcome|Week 24 Non-Responder Who Continued Treatment: Abatacept|Participants who were in the abatacept arm and non-responders at Week 24 who continued participation. If participation continued, participants continued abatacept up to Week 48 and azathioprine up to Week 52
1016487|NCT00774852|O2|Outcome|Week 24 Non-Responder: Placebo|Participants who were in the placebo arm and non-responders at Week 24 either terminated or continued participation. If participation continued, participants continued abatacept placebo up to Week 48 and azathioprine up to Week 52
1016488|NCT00774852|O1|Outcome|Week 24 Non-Responder: Abatacept|Participants who were in the abatacept arm and non-responders at Week 24 either terminated or continued participation. If participation continued, participants continued abatacept up to Week 48 and azathioprine up to Week 52
1016489|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
1016490|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
1016491|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
1016492|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
1016493|NCT00774852|O2|Outcome|Week 24 Complete Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a complete responder at their Week 24 visit discontinued abatacept placebo and switched to overencapsulated azathioprine up to Week 52
1016494|NCT00774852|O1|Outcome|Week 24 Complete Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a complete responder at their Week 24 visit discontinued abatacept and switched to overencapsulated azathioprine placebo up to Week 52
1016495|NCT00774852|O4|Outcome|Week 24 Partial Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a partial responder at their Week 24 visit continued to receive abatacept placebo up to Week 48 and azathioprine up to Week 52
1016496|NCT00774852|O3|Outcome|Week 24 Partial Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a partial responder at their Week 24 visit continued to receive abatacept up to Week 48 and azathioprine up to Week 52
1016497|NCT00774852|O2|Outcome|Week 24 Complete Response: Placebo|At Week 28 participants assigned to the Placebo group who were classified as a complete responder at their Week 24 visit discontinued abatacept placebo and switched to overencapsulated azathioprine up to Week 52
1016498|NCT00774852|O1|Outcome|Week 24 Complete Response: Abatacept|At Week 28 participants assigned to Abatacept group who were classified as a complete responder at their Week 24 visit discontinued abatacept and switched to overencapsulated azathioprine placebo up to Week 52
1016499|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
1016500|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
1016501|NCT00774852|O2|Outcome|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
1016502|NCT00774852|O1|Outcome|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
1016503|NCT00774852|E2|Reported Event|Placebo|Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
1016504|NCT00774852|E1|Reported Event|Abatacept|Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
1016505|NCT00774800|B1|Baseline|Overall Study|"Humalog+recombinant human hyaluronidase PH20 (rHuPH20): Up to 3 dose-finding (DF) visits (each visit separated by 3-10 days [d]) until an appropriate dose of Humalog was identified. For each DF visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously (SC) per unit of Humalog, corresponding to a mass concentration (conc) of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final conc of 91 U/mL of Humalog)~Humalog alone: After a 3-10 d washout (wo), a single SC injection of the appropriate identified dose of Humalog was delivered~Humulin-R+rHuPH20: After a 3-10 d wo, up to 2 DF visits (both visits separated by 3-10 d) until an appropriate dose of Humulin-R was identified. For each DF visit, a total of 24 U of rHuPH20 was injected SC per unit of Humulin-R, corresponding to a mass conc of 20.0 μg/mL rHuPH20 (at final conc of 100 U/mL of Humulin-R)~Humulin-R alone: After a 3-10 d wo, a single SC injection of the appropriate identified dose of Humulin-R was delivered"
1016506|NCT00774800|P1|Participant Flow|First Humalog+PH20, Then Humalog, Humulin-R+PH20, Humulin-R|"Humalog + Recombinant human hyaluronidase PH20 (rHuPH20) (Intervention 1): 24 units (U) of rHuPH20 per unit of Humalog, injected subcutaneously (SC), for up to 3 visits until an appropriate dose was identified.~Humalog alone (Intervention 2): a single SC injection of the appropriate identified dose of Humalog, delivered before a liquid meal.~Humulin-R + rHuPH20 (Intervention 3): 24 U of rHuPH20 per unit of Humulin-R, injected SC, for up to 2 visits until an appropriate dose was identified.~Humulin-R alone (Intervention 4): a single SC injection of the appropriate identified dose of Humulin-R, delivered before a liquid meal.~Appropriate dose of either Humalog or Humulin-R was that at which blood glucose following a liquid meal was <160 milligrams per deciliter (mg/dL) for more than 30 minutes during the first 4 hours after injection and never fell below 60 mg/dL.~All dose finding visits and interventions were separated by 3-10 days."
1016508|NCT00774800|O3|Outcome|Humulin-R + rHuPH20|After a 3-10 day washout, Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 2 dose-finding visits (both visits were separated by 3-10 days) until an appropriate dose of Humulin-R was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humulin-R, corresponding to a mass concentration of 20.0 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 100 U/mL of Humulin-R).
1016509|NCT00774800|O2|Outcome|Humalog Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humalog was delivered before a liquid meal.
1016510|NCT00774800|O1|Outcome|Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 3 dose-finding visits (each visit was separated by 3-10 days) until an appropriate dose of Humalog was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humalog, corresponding to a mass concentration of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 91 U/mL of Humalog).
1016511|NCT00774800|O4|Outcome|Humulin-R Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humulin-R was delivered before a liquid meal.
1016512|NCT00774800|O3|Outcome|Humulin-R + rHuPH20|After a 3-10 day washout, Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 2 dose-finding visits (both visits were separated by 3-10 days) until an appropriate dose of Humulin-R was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humulin-R, corresponding to a mass concentration of 20.0 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 100 U/mL of Humulin-R).
1016513|NCT00774800|O2|Outcome|Humalog Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humalog was delivered before a liquid meal.
1016514|NCT00774800|O1|Outcome|Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 3 dose-finding visits (each visit was separated by 3-10 days) until an appropriate dose of Humalog was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humalog, corresponding to a mass concentration of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 91 U/mL of Humalog).
1016515|NCT00774800|O4|Outcome|Humulin-R Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humulin-R was delivered before a liquid meal.
1016516|NCT00774800|O3|Outcome|Humulin-R + rHuPH20|After a 3-10 day washout, Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 2 dose-finding visits (both visits were separated by 3-10 days) until an appropriate dose of Humulin-R was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humulin-R, corresponding to a mass concentration of 20.0 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 100 U/mL of Humulin-R).
1016517|NCT00774800|O2|Outcome|Humalog Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humalog was delivered before a liquid meal.
1016518|NCT00774800|O1|Outcome|Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 3 dose-finding visits (each visit was separated by 3-10 days) until an appropriate dose of Humalog was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humalog, corresponding to a mass concentration of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 91 U/mL of Humalog).
1016519|NCT00774800|O4|Outcome|Humulin-R Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humulin-R was delivered before a liquid meal.
1016520|NCT00774800|O3|Outcome|Humulin-R + rHuPH20|After a 3-10 day washout, Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 2 dose-finding visits (both visits were separated by 3-10 days) until an appropriate dose of Humulin-R was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humulin-R, corresponding to a mass concentration of 20.0 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 100 U/mL of Humulin-R).
1016521|NCT00774800|O2|Outcome|Humalog Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humalog was delivered before a liquid meal.
1016522|NCT00774800|O1|Outcome|Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 3 dose-finding visits (each visit was separated by 3-10 days) until an appropriate dose of Humalog was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humalog, corresponding to a mass concentration of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 91 U/mL of Humalog).
1016523|NCT00774800|E4|Reported Event|Humulin-R Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humulin-R was delivered before a liquid meal.
1016524|NCT00774800|E3|Reported Event|Humulin-R + rHuPH20|After a 3-10 day washout, Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 2 dose-finding visits (both visits were separated by 3-10 days) until an appropriate dose of Humulin-R was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humulin-R, corresponding to a mass concentration of 20.0 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 100 U/mL of Humulin-R).
1016525|NCT00774800|E2|Reported Event|Humalog Alone|After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humalog was delivered before a liquid meal.
1016526|NCT00774800|E1|Reported Event|Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 3 dose-finding visits (each visit was separated by 3-10 days) until an appropriate dose of Humalog was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humalog, corresponding to a mass concentration of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 91 U/mL of Humalog).
1016527|NCT00774787|B1|Baseline|Cryotherapy Followed by Imiquimod 5% Cream or Observation|Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
1016832|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
1016528|NCT00774787|P1|Participant Flow|Cryotherapy Followed by Imiquimod 5% Cream or Observation|Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
1016529|NCT00774787|O1|Outcome|Cryotherapy Followed by Imiquimod 5% Cream or Observation|Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
1016530|NCT00774787|O1|Outcome|Cryotherapy Followed by Imiquimod 5% Cream or Observation|Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
1016531|NCT00774787|O1|Outcome|Cryotherapy Followed by Imiquimod 5% Cream or Observation|Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
1016532|NCT00774787|O1|Outcome|Cryotherapy Followed by Imiquimod 5% Cream or Observation|Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
1016533|NCT00774787|E1|Reported Event|Cryotherapy Followed by Imiquimod 5% Cream or Observation|Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment
1016534|NCT00774748|B1|Baseline|Insuflon|All participants in the study will use the subcutaneous catheter twice for a period of one week each to inject the enoxaparin. For the remainder of the study the participants will inject subcutaneously.
1016535|NCT00774748|P1|Participant Flow|Insuflon|All participants in the study will use the subcutaneous catheter twice for a period of one week each to inject the enoxaparin. For the remainder of the study the participants will inject subcutaneously.
1016536|NCT00774748|O1|Outcome|All Participants|All participants on both a daily and twice daily dosing schedule
1016537|NCT00774748|O1|Outcome|Once Daily Dosing|10 participants were placed on an once daily dosing schedule in accordance with their physician approved, standard of care weight specific dosage.
1016538|NCT00774748|O1|Outcome|All Participants|All participants on both dosing schedules, once and twice daily.
1016539|NCT00774748|O1|Outcome|All Participants|All participants on both dosing schedules, once and twice daily LMWH.
1016540|NCT00774748|O1|Outcome|All Participants|Both dosing schedules, once and twice daily, all participants.
1016541|NCT00774748|E1|Reported Event|Insuflon|All participants in the study will use the subcutaneous catheter twice for a period of one week each to inject the enoxaparin. For the remainder of the study the participants will inject subcutaneously.
1016542|NCT00774397|B8|Baseline|Total|Total of all reporting groups
1016543|NCT00774397|B7|Baseline|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016544|NCT00774397|B6|Baseline|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016545|NCT00774397|B5|Baseline|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016546|NCT00774397|B4|Baseline|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016547|NCT00774397|B3|Baseline|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016548|NCT00774397|B2|Baseline|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016549|NCT00774397|B1|Baseline|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016550|NCT00774397|P7|Participant Flow|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016551|NCT00774397|P6|Participant Flow|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016552|NCT00774397|P5|Participant Flow|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1017766|NCT00772603|O2|Outcome|1200mg/Day SPN-804|1200mg SPN-804O given once daily
1016553|NCT00774397|P4|Participant Flow|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016554|NCT00774397|P3|Participant Flow|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016555|NCT00774397|P2|Participant Flow|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016556|NCT00774397|P1|Participant Flow|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV (Pegylated interferon α-2a (Pegasys®)/ Ribavirin (Copegus®)): PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016557|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016558|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016559|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016560|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016561|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016562|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016563|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016564|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016565|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016566|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016567|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016568|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016569|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016570|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016571|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016572|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016833|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
1017767|NCT00772603|O1|Outcome|2400mg/Day SPN-804|2400mg SPN-804O once daily
1016573|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016574|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016575|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016576|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016577|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016578|NCT00774397|O6|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016579|NCT00774397|O5|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016580|NCT00774397|O4|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016581|NCT00774397|O3|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016582|NCT00774397|O2|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016583|NCT00774397|O1|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016584|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016585|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016586|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016587|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016588|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016589|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016590|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016591|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016592|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016834|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
1016593|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016594|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016595|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016596|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016597|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016598|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016599|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016600|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016601|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016602|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016603|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016604|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016605|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016606|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016607|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016608|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016609|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016610|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016611|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016612|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016613|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016614|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016615|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016616|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016617|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016618|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016619|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016620|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016621|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016622|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016623|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016624|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016625|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016626|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016627|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016628|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016629|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016630|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016631|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016632|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016633|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016634|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016635|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016636|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016637|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016638|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016639|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016640|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016641|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016642|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016643|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016644|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016645|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016646|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016647|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016648|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016649|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016650|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016651|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016652|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016653|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016654|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016655|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016656|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016657|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016658|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016659|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016660|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016661|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016662|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016663|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016664|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016665|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016666|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016667|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016668|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016669|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016670|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016671|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016672|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016673|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016674|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016675|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016676|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016677|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016678|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016679|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016680|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016681|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016682|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016683|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016684|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016685|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016686|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016687|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016688|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016689|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016690|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016691|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016692|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016693|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016694|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016695|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016696|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016697|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016698|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016699|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016700|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016701|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016702|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016703|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016704|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016705|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016706|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016707|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016708|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016709|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016710|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016711|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016712|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016713|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016714|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016715|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016716|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016717|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016718|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016719|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016720|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016721|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016722|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016723|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016724|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016725|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016726|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016727|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016728|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016729|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016730|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016731|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016732|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016733|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016734|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016735|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016736|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016737|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016738|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016739|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016740|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016741|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016742|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016743|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016744|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016745|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016746|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016747|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016748|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016749|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016750|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016751|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016752|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016753|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016754|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016755|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016756|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016757|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016758|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016759|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016760|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016761|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016762|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016763|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016764|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016765|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016766|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016767|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016768|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016769|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016770|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016771|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016772|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016773|NCT00774397|O7|Outcome|240 mg BID / LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016774|NCT00774397|O6|Outcome|240 mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016775|NCT00774397|O5|Outcome|240 mg QD / LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016776|NCT00774397|O4|Outcome|240 mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016777|NCT00774397|O3|Outcome|240 mg QD / LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016778|NCT00774397|O2|Outcome|120 mg QD / LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016779|NCT00774397|O1|Outcome|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016780|NCT00774397|E7|Reported Event|240mg BID/LI-TE|"240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016781|NCT00774397|E6|Reported Event|240mg QD-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016782|NCT00774397|E5|Reported Event|240mg QD/LI-TE|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016783|NCT00774397|E4|Reported Event|240mg QD-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016784|NCT00774397|E3|Reported Event|240mg QD/LI-TN|"240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016785|NCT00774397|E2|Reported Event|120mg QD/LI-TN|"120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients~[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016786|NCT00774397|E1|Reported Event|Placebo-TN|"Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients~[PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]"
1016787|NCT00774306|B5|Baseline|Total|Total of all reporting groups
1016788|NCT00774306|B4|Baseline|No Anticonvulsant|Participants randomized to Group 4 will receive no drug intervention.
1016789|NCT00774306|B3|Baseline|Levetiracetam|"Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.~levetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses."
1016790|NCT00774306|B2|Baseline|Valproate|"Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.~valproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses."
1016791|NCT00774306|B1|Baseline|Phenytoin|"Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.~phenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses."
1016792|NCT00774306|P4|Participant Flow|No Anticonvulsant|Participants randomized to Group 4 will receive no drug intervention.
1016793|NCT00774306|P3|Participant Flow|Levetiracetam|"Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.~levetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses."
1016794|NCT00774306|P2|Participant Flow|Valproate|"Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.~valproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses."
1016795|NCT00774306|P1|Participant Flow|Phenytoin|"Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.~phenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses. They will be maintained on it throughout the study period. Daily dose will be adjusted to maintain levels in the standard therapeutic range of 10-20 mg/dL. Upon discharge, they will remain on the drug in oral form until follow-up with the principal investigator 6 weeks later.~x~x"
1016796|NCT00774306|O4|Outcome|No Anticonvulsant|Participants randomized to Group 4 will receive no drug intervention.
1016797|NCT00774306|O3|Outcome|Levetiracetam|"Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.~levetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses."
1016798|NCT00774306|O2|Outcome|Valproate|"Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.~valproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses."
1016799|NCT00774306|O1|Outcome|Phenytoin|"Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.~phenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses. They will be maintained on it throughout the study period.~x~x"
1016800|NCT00774306|E4|Reported Event|No Anticonvulsant|Participants randomized to Group 4 will receive no drug intervention.
1016801|NCT00774306|E3|Reported Event|Levetiracetam|"Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.~levetiracetam: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses."
1016802|NCT00774306|E2|Reported Event|Valproate|"Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation.~valproate: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses."
1016803|NCT00774306|E1|Reported Event|Phenytoin|"Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.~phenytoin: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses. They will be maintained on it throughout the study period.~x~x"
1016804|NCT00774267|B5|Baseline|Total|Total of all reporting groups
1016805|NCT00774267|B4|Baseline|Placebo|Participants who received placebo capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
1016806|NCT00774267|B3|Baseline|Raloxifene 60 mg|Participants who received raloxifene 60 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
1016835|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
1016807|NCT00774267|B2|Baseline|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.625 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
1016808|NCT00774267|B1|Baseline|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.45 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
1016809|NCT00774267|P4|Participant Flow|Placebo|Participants who received placebo capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
1016810|NCT00774267|P3|Participant Flow|Raloxifene 60 mg|Participants who received raloxifene 60 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
1016811|NCT00774267|P2|Participant Flow|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.625 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
1016812|NCT00774267|P1|Participant Flow|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.45 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
1016813|NCT00774267|O4|Outcome|Placebo|Participants who received placebo capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
1016814|NCT00774267|O3|Outcome|Raloxifene 60 mg|Participants who received raloxifene 60 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
1016815|NCT00774267|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.625 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
1016816|NCT00774267|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.45 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
1016817|NCT00774267|E4|Reported Event|Placebo|Participants who received placebo capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
1016818|NCT00774267|E3|Reported Event|Raloxifene 60 mg|Participants who received raloxifene 60 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
1016819|NCT00774267|E2|Reported Event|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.625 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
1016820|NCT00774267|E1|Reported Event|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Participants who received bazedoxifene 20 mg/conjugated estrogen 0.45 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study.
1016821|NCT00774163|B3|Baseline|Total|Total of all reporting groups
1016822|NCT00774163|B2|Baseline|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
1016823|NCT00774163|B1|Baseline|Lactobacillus Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
1016824|NCT00774163|P2|Participant Flow|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
1016825|NCT00774163|P1|Participant Flow|Lactobacillus Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
1016826|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
1016827|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
1016828|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
1016829|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
1016830|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
1016836|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
1016837|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
1016838|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
1016839|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
1016840|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
1016841|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
1016842|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
1016843|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
1016844|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
1016845|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
1016846|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
1016847|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
1016848|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
1016849|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
1016850|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
1016851|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
1016852|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
1016853|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
1016854|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
1016855|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
1016856|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
1016857|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
1016858|NCT00774163|O2|Outcome|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
1016859|NCT00774163|O1|Outcome|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
1016860|NCT00774163|E2|Reported Event|Placebo Group|Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
1016861|NCT00774163|E1|Reported Event|Lactobacillus Reuteri Group|Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period
1016862|NCT00774046|B1|Baseline|All Patients|Ara-C Mitoxantrone Etoposide
1016863|NCT00774046|P1|Participant Flow|Induction Chemotherapy Followed by Stem Cell Transplant|Ara-C Mitoxantrone Etoposide Stem cell mobilization Autologous transplant
1016864|NCT00774046|O1|Outcome|All Patients|Ara-C Mitoxantrone Etoposide
1016865|NCT00774046|O1|Outcome|All Patients|Ara-C Mitoxantrone Etoposide
1016866|NCT00774046|O1|Outcome|All Patients|Ara-C Mitoxantrone Etoposide
1016867|NCT00774046|O1|Outcome|All Patients|Ara-C Mitoxantrone Etoposide
1016868|NCT00774046|O1|Outcome|All Patients|Ara-C Mitoxantrone Etoposide
1016869|NCT00774046|O1|Outcome|All Patients|Ara-C Mitoxantrone Etoposide
1016870|NCT00774046|O1|Outcome|All Patients|Ara-C Mitoxantrone Etoposide
1016871|NCT00774046|E1|Reported Event|All Patients|Ara-C Mitoxantrone Etoposide
1016872|NCT00773968|B1|Baseline|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant’s Hb value.
1016901|NCT00773734|B3|Baseline|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1016902|NCT00773734|B2|Baseline|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
1016873|NCT00773968|P1|Participant Flow|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta (also known as continuous erythropoietin receptor activator [CERA]) once monthly by subcutaneous (SC) injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 micrograms (µg) if the last weekly dose of previous erythropoietin stimulating agent (ESA) (darbepoetin alfa) was less than (<) 40 µg or 40-80 µg or greater than (>) 80 µg, respectively. The doses were adjusted according to individual participant’s hemoglobin (Hb) value.
1016874|NCT00773968|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant’s Hb value.
1016875|NCT00773968|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant’s Hb value.
1016876|NCT00773968|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant’s Hb value.
1016877|NCT00773968|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant’s Hb value.
1016878|NCT00773968|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant’s Hb value.
1016879|NCT00773968|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant’s Hb value.
1016880|NCT00773968|E1|Reported Event|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was <40 µg or 40-80 µg or >80 µg, respectively. The doses were adjusted according to individual participant’s Hb value.
1016881|NCT00773955|B1|Baseline|Treatment (R-(-)-Gossypol)|Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1016882|NCT00773955|P1|Participant Flow|Treatment (R-(-)-Gossypol)|Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1016883|NCT00773955|O1|Outcome|Treatment (R-(-)-Gossypol)|Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1016884|NCT00773955|O1|Outcome|Treatment (R-(-)-Gossypol)|Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1016885|NCT00773955|O1|Outcome|Treatment (R-(-)-Gossypol)|Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1016886|NCT00773955|O1|Outcome|Treatment (R-(-)-Gossypol)|Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1016887|NCT00773955|E1|Reported Event|Treatment (R-(-)-Gossypol)|Patients receive oral R-(-)-gossypol once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1016888|NCT00773786|B1|Baseline|All Study Participants|Participants randomized and received either Tiotropium + Brovana twice daily for 1 week or Tiotropium + placebo twice daily for 1 week.
1016889|NCT00773786|P2|Participant Flow|Placebo, Then Arformoterol (Brovana)|Participants first received Tiotropium + Placebo twice daily for 1 week . After a 1 week washout period, they received Tiotropium + Brovana twice daily for 1 week via nebulizer.
1016890|NCT00773786|P1|Participant Flow|Tiotropium + Arformoterol (Brovana), Then Tiotropium + Placebo|Participants first received Tiotropium + Brovana twice daily for 1 week via nebulizer. After a 1 week washout period, they received Tiotropium + placebo twice daily for 1 week.
1016891|NCT00773786|O2|Outcome|Placebo|Participants who received Tiotropium + Placebo twice daily for 1 week
1016892|NCT00773786|O1|Outcome|Brovana (Arformoterol)|Participants who received Tiotropium + Brovana twice daily for 1 week via nebulizer
1016893|NCT00773786|O2|Outcome|Placebo|Participants who received Tiotropium + Placebo twice daily for 1 week.
1016894|NCT00773786|O1|Outcome|Brovana (Arformoterol)|Participants who received Tiotropium + Brovana twice daily for 1 week via nebulizer
1016895|NCT00773786|O2|Outcome|Placebo|Participants who received Tiotropium + Placebo twice daily for 1 week.
1016896|NCT00773786|O1|Outcome|Brovana (Arformoterol)|Participants who received Tiotropium + Brovana twice daily for 1 week via nebulizer
1016897|NCT00773786|E2|Reported Event|Placebo|Placebo twice daily for 1 week
1016898|NCT00773786|E1|Reported Event|Arformoterol|Arformoterol twice daily for 1 week via nebulizer
1016899|NCT00773734|B5|Baseline|Total|Total of all reporting groups
1016900|NCT00773734|B4|Baseline|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1016903|NCT00773734|B1|Baseline|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16).
1016904|NCT00773734|P6|Participant Flow|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1016905|NCT00773734|P5|Participant Flow|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1016906|NCT00773734|P4|Participant Flow|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1016907|NCT00773734|P3|Participant Flow|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1016908|NCT00773734|P2|Participant Flow|Apremilast 10mg BID|Participants were initially randomized to apremilast (APR) 10 mg by mouth (PO) BID during the Placebo-controlled Phase (Weeks 0-16).
1016909|NCT00773734|P1|Participant Flow|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
1016910|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1016911|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1016912|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1016913|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
1016914|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
1016915|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1016916|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1016917|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1016918|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
1016919|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
1016920|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1016921|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017768|NCT00772603|O3|Outcome|Placebo|Placebo given once daily.
1016922|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1016923|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
1016924|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
1016925|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1016926|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1016927|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1016928|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
1016929|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
1016930|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1016931|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1016932|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1016933|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1016934|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1016935|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1016936|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1016937|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1016938|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1016939|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017501|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1016940|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1016941|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1016942|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1016943|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1016944|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1016945|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1016946|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1016947|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1016948|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1016949|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1016950|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1016951|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1016952|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1016953|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1016954|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1016955|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017004|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
1017769|NCT00772603|O2|Outcome|1200mg/Day SPN-804|1200mg SPN-804O given once daily
1016956|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1016957|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1016958|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1016959|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1016960|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1016961|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1016962|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1016963|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1016964|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1016965|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1016966|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1016967|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1016968|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1016969|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1016970|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017005|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017050|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1023906|NCT00760578|O2|Outcome|MSDC-0160 220 mg|MSDC-0160 220 mg once daily
1016971|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1016972|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1016973|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1016974|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1016975|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1016976|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1016977|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1016978|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1016979|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1016980|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1016981|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1016982|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1016983|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1016984|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1016985|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017048|NCT00773734|O2|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24
1017049|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
1023907|NCT00760578|O1|Outcome|MSDC-0160 90 mg|MSDC-0160 90 mg once daily
1016986|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1016987|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1016988|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1016989|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1016990|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1016991|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1016992|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1016993|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
1016994|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
1016995|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1016996|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1016997|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1016998|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
1016999|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
1017000|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017001|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017002|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017003|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
1017667|NCT00772928|O1|Outcome|Pentacel™ Concurrently With Prevnar®|Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine
1017006|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017007|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017008|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
1017009|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
1017010|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017011|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017012|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017013|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
1017014|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
1017015|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017016|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017017|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017018|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
1017019|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
1017020|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017021|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017022|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017023|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
1017024|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
1017025|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017026|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017027|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017028|NCT00773734|O2|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
1017029|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
1017030|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017031|NCT00773734|O4|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
1017032|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017033|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017034|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
1017035|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017036|NCT00773734|O4|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24.
1017037|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017038|NCT00773734|O2|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24
1017039|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
1017040|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017041|NCT00773734|O4|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24.
1017042|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017043|NCT00773734|O2|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24
1017044|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
1017045|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017046|NCT00773734|O4|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24.
1017047|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017502|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017051|NCT00773734|O4|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24.
1017052|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017053|NCT00773734|O2|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24
1017054|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
1017055|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017056|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017057|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017058|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017059|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017060|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017061|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017062|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017063|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017064|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017065|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017066|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017067|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017136|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017503|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017068|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017069|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017070|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017071|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017072|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017073|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017074|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017075|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017076|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017077|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017078|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017079|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017080|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017081|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017082|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017137|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) continued dosing with apremilast 10mg PO BID through Week 52 of the extension phase. Participants who received 10mg PO BID at the end of the extension study were randomly assigned to apremilast 20 mg or 30 mg PO BID during the long term extension study. (LTE).
1017464|NCT00773734|E6|Reported Event|Apremilast 20mg BID (APR Exposure Period) Years 0-6|Participants who received 20 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 16 or Week 52), up to 6 years.
1017083|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017084|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017085|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017086|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017087|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017088|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017089|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017090|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017091|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017092|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017093|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017094|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017095|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017096|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017097|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017138|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017139|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1024986|NCT00758459|O1|Outcome|AZD1236|AZD1236
1017098|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017099|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017100|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017101|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017102|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017103|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017104|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017105|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017106|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017107|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017108|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017109|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017110|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017111|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017112|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017140|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
1017141|NCT00773734|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16).
1017495|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017770|NCT00772603|O1|Outcome|2400mg/Day SPN-804|2400mg SPN-804O once daily
1017113|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017114|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017115|NCT00773734|O5|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017116|NCT00773734|O4|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017117|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017118|NCT00773734|O2|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017119|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017120|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017121|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017122|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) continued dosing with apremilast 10mg PO BID through Week 52 of the extension phase. Participants who received 10mg PO BID at the end of the extension study were randomly assigned to apremilast 20 mg or 30 mg PO BID during the long term extension study. (LTE).
1017123|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017124|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017125|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
1017126|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
1017127|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017128|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017129|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
1017130|NCT00773734|O1|Outcome|Placebo BID|.Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
1017131|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017132|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017133|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
1017134|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16)
1017135|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017496|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017142|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017143|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017144|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017145|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017146|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017147|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017148|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017149|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017150|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017151|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017152|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017153|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017154|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017155|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017156|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017361|NCT00773734|O4|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
1017362|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017157|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017158|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017159|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017160|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017161|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017162|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017163|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017164|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017165|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017166|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017167|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017168|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017169|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017170|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017171|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017363|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017364|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
1017771|NCT00772603|O3|Outcome|Placebo|Placebo given once daily.
1017172|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017173|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017174|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017175|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017176|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017177|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017178|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017179|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017180|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017181|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017182|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017183|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017184|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017185|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017186|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017365|NCT00773734|O5|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
1017366|NCT00773734|O4|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
1017187|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017188|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017189|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017190|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017191|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017192|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017193|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017194|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017195|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017196|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017197|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017198|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017199|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017200|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017201|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017367|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017368|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1024987|NCT00758459|O2|Outcome|Placebo|Placebo
1017202|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017203|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017204|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017205|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017206|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017207|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017208|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017209|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017210|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017211|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017212|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017213|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017214|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017215|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017216|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017369|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
1017370|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017772|NCT00772603|O2|Outcome|1200mg/Day SPN-804|1200mg SPN-804O given once daily
1017217|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017218|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017219|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017220|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017221|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017222|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017223|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017224|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017225|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017226|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017227|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017228|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017229|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017230|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017231|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017371|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017372|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
1017373|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
1017232|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017233|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017234|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017235|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017236|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017237|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017238|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017239|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017240|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017241|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017242|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017243|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017244|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017245|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017246|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017374|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017375|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1024988|NCT00758459|O1|Outcome|AZD1236|AZD1236
1017247|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017248|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017249|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017250|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017251|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017252|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017253|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017254|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017255|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017256|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017257|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017258|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017259|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017260|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017261|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017376|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
1017377|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
1017497|NCT00773461|O1|Outcome|Placebo+DMARD|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017714|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
1017262|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017263|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017264|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017265|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017266|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017267|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017268|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017269|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017270|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017271|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017272|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017273|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017274|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017275|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017276|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017401|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017402|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1024989|NCT00758459|O2|Outcome|Placebo|Placebo
1017277|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017278|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017279|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017280|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017281|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017282|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017283|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017284|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017285|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017286|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017287|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017288|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017289|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017290|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017291|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017403|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast (APR) 10 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16).
1017404|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
1017498|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017773|NCT00772603|O1|Outcome|2400mg/Day SPN-804|2400mg SPN-804O once daily
1017292|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017293|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017294|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017295|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017296|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017297|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017298|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017299|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017300|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017301|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017302|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017303|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017304|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017305|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017306|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017432|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017433|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017774|NCT00772603|O3|Outcome|Placebo|Placebo once daily.
1017307|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017308|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017309|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017310|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017311|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017312|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017313|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017314|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017315|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017316|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017317|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017318|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017319|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017320|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017321|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017434|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
1017435|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
1017499|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017715|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
1017322|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017323|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017324|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017325|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017326|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017327|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017328|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017329|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017330|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017331|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017332|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017333|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017334|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017335|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017336|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017461|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
1017462|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
1017463|NCT00773734|E7|Reported Event|Apremilast 30mg BID (APR Exposure Period) Years 0-6|Participants who received 30 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 16 or Week 52), up to 6 years.
1017337|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017338|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017339|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017340|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017341|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).
1017342|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017343|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017344|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
1017345|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017346|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017347|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
1017348|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017349|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017350|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
1017351|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017352|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017353|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
1017354|NCT00773734|O3|Outcome|Apremilast 30 mg|Participants who were initially randomized to apremilast 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 30 mg BID during the Active Treatment Phase (Weeks 16-24).
1017355|NCT00773734|O2|Outcome|Apremilast 20mg|Participants who were initially randomized to apremilast 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 20 mg BID during the Active Treatment Phase (Weeks 16-24).
1017356|NCT00773734|O1|Outcome|Apremilast 10mg|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
1017357|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017358|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017359|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
1017360|NCT00773734|O5|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
1017500|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017378|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017379|NCT00773734|O4|Outcome|Placebo-Apremilast (APR) 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
1017380|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017381|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017382|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
1017383|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017384|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017385|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
1017386|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
1017387|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017388|NCT00773734|O4|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
1017389|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017390|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017391|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
1017392|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017393|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017394|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
1017395|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
1017396|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017397|NCT00773734|O4|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
1017398|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017399|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017400|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
1017405|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017406|NCT00773734|O4|Outcome|Placebo-Apremilast 20 mg BID|Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
1017407|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017408|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017409|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
1017410|NCT00773734|O4|Outcome|Apremilast 30 mg|Participants were initially randomized to apremilast 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
1017411|NCT00773734|O3|Outcome|Apremilast 20mg|Participants were initially randomized to apremilast 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
1017412|NCT00773734|O2|Outcome|Apremilast 10mg|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
1017413|NCT00773734|O1|Outcome|Placebo|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
1017414|NCT00773734|O5|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24.
1017415|NCT00773734|O4|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24
1017416|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017417|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017418|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
1017419|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017420|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017421|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
1017422|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16). .
1017423|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017424|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017425|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
1017426|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
1017427|NCT00773734|O5|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to identically matching placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
1017428|NCT00773734|O4|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to identically matching placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg tablets BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
1017429|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017430|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017431|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to APR 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
1017759|NCT00772603|P3|Participant Flow|Placebo|Placebo once daily
1017436|NCT00773734|O5|Outcome|Placebo-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017437|NCT00773734|O4|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).
1017438|NCT00773734|O3|Outcome|Apremilast 30 mg|Participants who were initially randomized to apremilast 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 30 mg BID during the Active Treatment Phase (Weeks 16-24).
1017439|NCT00773734|O2|Outcome|Apremilast 20mg|Participants who were initially randomized to apremilast 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 20 mg BID during the Active Treatment Phase (Weeks 16-24).
1017440|NCT00773734|O1|Outcome|Apremilast 10mg|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
1017441|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017442|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017443|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
1017444|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)
1017445|NCT00773734|O5|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
1017446|NCT00773734|O4|Outcome|Placebo-Apremilast 20mg BID|Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.
1017447|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017448|NCT00773734|O2|Outcome|Apremilast 20mg|Participants who were initially randomized to apremilast 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 20 mg BID during the Active Treatment Phase (Weeks 16-24).
1017449|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).
1017450|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017451|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017452|NCT00773734|O2|Outcome|Apremilast 10mg BID|Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
1017453|NCT00773734|O1|Outcome|Placebo BID|Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16).
1017454|NCT00773734|O5|Outcome|PBO-Apremilast 30 mg BID|Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).
1017455|NCT00773734|O4|Outcome|PBO-Apremilast 20mg BID|Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg PO BID during the active treatment phase (Weeks 16-24).
1017456|NCT00773734|O3|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017457|NCT00773734|O2|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017458|NCT00773734|O1|Outcome|Apremilast 10mg BID|Participants who were initially randomized to apremilast 10mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on APR 10 mg BID PO during the Active Treatment Phase (Weeks 16-24).
1017459|NCT00773734|O4|Outcome|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.
1017460|NCT00773734|O3|Outcome|Apremilast 20mg BID|Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.
1017465|NCT00773734|E5|Reported Event|Apremilast 10mg BID (APR Exposure Period) Years 0-6|Participants initially randomized to 10 mg PO BID apremilast at Week 0. Participants who were dosed with apremilast 10mg BID in the extension study were randomly assigned to either apremilast 20 mg or 30 mg BID in the long term extension study (LTE).
1017466|NCT00773734|E4|Reported Event|Apremilast 30mg BID (Weeks 0-16)|Participants randomized to apremilast 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16)
1017467|NCT00773734|E3|Reported Event|Apremilast 20mg BID (Weeks 0-16)|Participants randomized to apremilast 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16)
1017468|NCT00773734|E2|Reported Event|Apremilast 10mg BID (Weeks 0-16)|Participants randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).
1017469|NCT00773734|E1|Reported Event|Placebo (Weeks 0-16)|Participants randomized to placebo PO BID during the Placebo-controlled Phase
1017470|NCT00773474|B1|Baseline|Lonafarnib|"All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.~Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator’s discretion."
1017471|NCT00773474|P1|Participant Flow|Lonafarnib|"All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.~Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator’s discretion."
1017472|NCT00773474|O1|Outcome|Lonafarnib|"All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.~Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator’s discretion."
1017473|NCT00773474|O1|Outcome|Lonafarnib|"All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.~Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator’s discretion."
1017474|NCT00773474|O1|Outcome|Lonafarnib|"All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.~Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator’s discretion."
1017475|NCT00773474|O1|Outcome|Lonafarnib|"All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.~Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator’s discretion."
1017476|NCT00773474|E1|Reported Event|Lonafarnib|"All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.~Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator’s discretion."
1017477|NCT00773461|B3|Baseline|Total|Total of all reporting groups
1017478|NCT00773461|B2|Baseline|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017479|NCT00773461|B1|Baseline|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017480|NCT00773461|P2|Participant Flow|Tocilizumab + DMARDs|Participants received tocilizumab 8 milligrams/kilogram (mg/kg) intravenously (iv) every 4 weeks up to 24 weeks in combination with stable DMARD (disease modifying antirheumatic drugs) therapy
1017481|NCT00773461|P1|Participant Flow|Placebo + DMARDs|Participants received placebo intravenously (iv) every 4 weeks up to 24 weeks in combination with stable DMARD (disease modifying antirheumatic drugs) therapy
1017482|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017483|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017484|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017485|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017486|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017487|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017488|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017489|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017490|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017491|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017492|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017493|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017494|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017775|NCT00772603|O2|Outcome|1200mg/Day SPN-804|1200mg SPN-804 once daily
1017504|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017505|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017506|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017507|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017508|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017509|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017510|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017511|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017512|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017513|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017514|NCT00773461|O2|Outcome|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017515|NCT00773461|O1|Outcome|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017516|NCT00773461|E2|Reported Event|Tocilizumab + DMARDs|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017517|NCT00773461|E1|Reported Event|Placebo + DMARDs|Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
1017518|NCT00773383|B1|Baseline|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
1017519|NCT00773383|P1|Participant Flow|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
1017520|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
1017521|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
1017522|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
1017523|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
1017524|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
1017525|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
1017526|NCT00773383|O4|Outcome|R1507_Baseline Missing|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib - 150 mg Once daily administration (qd) Oral administration(PO) Includes all participants with missing fasting glucose at baseline
1017527|NCT00773383|O3|Outcome|R1507_Baseline Diabetes Mellitus|"9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)~Includes all participants with a fasting glucose at baseline ≥ 126 mg/dL"
1017528|NCT00773383|O2|Outcome|R1507_Baseline Impaired Fasting Glucose|"9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)~Includes all participants with a fasting glucose at baseline ≥ 110 to < 126 mg/dL"
1017529|NCT00773383|O1|Outcome|R1507_Baseline Glucose Normal|"9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)~Includes all participants with a fasting glucose at baseline < 110 mg/dL."
1017530|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
1017531|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
1017532|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
1017533|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
1017534|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
1017535|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
1017536|NCT00773383|O1|Outcome|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
1017537|NCT00773383|E1|Reported Event|R1507|9 mg/kg once a week (qw) IV administered over 60-90 minutes erlotinib – 150 mg Once daily administration (qd) Oral administration(PO)
1017538|NCT00773370|B3|Baseline|Total|Total of all reporting groups
1017539|NCT00773370|B2|Baseline|Sittercise|"Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.~Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework."
1017760|NCT00772603|P2|Participant Flow|1200mg/Day SPN-804|1200mg SPN-804O once daily
1017540|NCT00773370|B1|Baseline|APA-Stroke|"The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.~APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component."
1017541|NCT00773370|P2|Participant Flow|Sittercise|"Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.~Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework."
1017542|NCT00773370|P1|Participant Flow|APA-Stroke|"The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.~APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component."
1017543|NCT00773370|O2|Outcome|Sittercise|"Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.~Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework."
1017544|NCT00773370|O1|Outcome|APA-Stroke|"The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.~APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component."
1017545|NCT00773370|O2|Outcome|Sittercise|"Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.~Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework."
1017546|NCT00773370|O1|Outcome|APA-Stroke|"The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.~APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component."
1017547|NCT00773370|O2|Outcome|Sittercise|"Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.~Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework."
1017548|NCT00773370|O1|Outcome|APA-Stroke|"The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.~APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component."
1017549|NCT00773370|O2|Outcome|Sittercise|"Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.~Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework."
1017550|NCT00773370|O1|Outcome|APA-Stroke|"The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.~APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component."
1017551|NCT00773370|E2|Reported Event|Sittercise|"Sittercise is not stroke specific. This less vigorous exercise program consists of seated exercise, focusing on stretching to improve general range of motion and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework associated with this group.~Sittercise: Not stroke specific. This less vigorous exercise program consists of seated exercise focusing on stretching to improve general range of movement and weight exercises to strengthen the trunk, arms, and legs. There is no assigned exercise homework."
1017552|NCT00773370|E1|Reported Event|APA-Stroke|"The APA-stroke exercise program designed specifically for individuals with hemiparetic gait deficits due to stroke. These progressive exercises focus on walking, balance and weight shifting and include an exercise homework component.~APA-Stroke: Exercise program design specifically for individuals with residual hemiparetic gait deficits due to stroke. Exercises are progressive, beginning with a 5 minute walk at the beginning and end of each class and gradually progressing to a 15 minute walk at the beginning and end of each class. Exercises focus on walking and are designed to improve walking ability and balance. Program includes a homework component."
1017553|NCT00773279|B1|Baseline|Entire Trial Population|Participants who in random order received usual insulin treatment with pre-filled pen device PDS290 for 12 weeks followed by switch to pre-filled pen device FlexPen® for 12 weeks or vice versa. The frequency of basal and bolus injections were kept the same throughout the trial. Both prefilled pens were self-administered subcutaneously by the participants.
1017554|NCT00773279|P2|Participant Flow|FlexPen® -> PDS290|
1017555|NCT00773279|P1|Participant Flow|PDS290 -> FlexPen®|
1017556|NCT00773279|O2|Outcome|FlexPen®|Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
1017557|NCT00773279|O1|Outcome|PDS290|Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
1017558|NCT00773279|O2|Outcome|FlexPen®|Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
1017559|NCT00773279|O1|Outcome|PDS290|Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
1017560|NCT00773279|O2|Outcome|FlexPen®|Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
1017561|NCT00773279|O1|Outcome|PDS290|Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
1017562|NCT00773279|O2|Outcome|FlexPen®|Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
1017563|NCT00773279|O1|Outcome|PDS290|Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
1017564|NCT00773279|O2|Outcome|FlexPen®|Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
1017565|NCT00773279|O1|Outcome|PDS290|Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
1017566|NCT00773279|O2|Outcome|FlexPen®|Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
1017567|NCT00773279|O1|Outcome|PDS290|Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
1017568|NCT00773279|O1|Outcome|Entire Trial Population|Participants who in random order received usual insulin treatment with pre-filled pen device PDS290 for 12 weeks followed by switch to pre-filled pen device FlexPen® for 12 weeks or vice versa. The frequency of basal and bolus injections were kept the same throughout the trial. Both prefilled pens were self-administered subcutaneously by the participants.
1017569|NCT00773279|O2|Outcome|FlexPen®|Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
1017570|NCT00773279|O1|Outcome|PDS290|Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
1017571|NCT00773279|E2|Reported Event|FlexPen®|Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
1017572|NCT00773279|E1|Reported Event|PDS290|Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
1017573|NCT00773253|B3|Baseline|Total|Total of all reporting groups
1017574|NCT00773253|B2|Baseline|Multi-channel EMG-guided Botox Injection Then Single Channel|Patients will receive multi-channel EMG-guided Botox injection before or after they have been treated with single-channel EMG-guided Botox, depending on which group they are assigned in the cross-over design.
1017575|NCT00773253|B1|Baseline|Standard EMG Guided Injections Then Multi-channel|All patients will undergo injection using conventional single channel EMG-guided technique. This will be used as a baseline for multi-channel mapping-based injections. Patients will be randomized to undergo single-channel vs. multi-channel assessment upon study entry and will then cross over to the alternate arm.
1017576|NCT00773253|P2|Participant Flow|Multi-channel EMG-guided Botox Injection Then Standard EMG Inj|Patients will receive multi-channel EMG-guided Botox injection before or after they have been treated with single-channel (standard) EMG-guided Botox, depending on which group they are assigned in the cross-over design.
1017577|NCT00773253|P1|Participant Flow|Standard EMG Guided Injections Then Multi-channel Injections|All patients will undergo injection using conventional single channel (standard)EMG-guided technique. This will be used as a baseline for multi-channel mapping-based injections. Patients will be randomized to undergo single-channel vs. multi-channel assessment upon study entry and will then cross over to the alternate arm.
1017578|NCT00773253|O2|Outcome|Multi-channel EMG-guided Botox Injection|Patients will receive multi-channel EMG-guided Botox injection.
1017579|NCT00773253|O1|Outcome|Standard EMG Guided Injections|All patients underwent single channel (standard)EMG-guided technique.
1017580|NCT00773253|E2|Reported Event|Multi-channel EMG-guided Botox Injection|Patients will receive multi-channel EMG-guided Botox injection.
1017581|NCT00773253|E1|Reported Event|Standard EMG Guided Injections|All patients underwent single channel (standard)EMG-guided technique.
1017582|NCT00773136|B1|Baseline|Bimatoprost Mixed With Gonak Into a Gel Suspension|Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye.
1017583|NCT00773136|P1|Participant Flow|Bimatoprost Mixed With Gonak Into a Gel Suspension|Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye.
1017584|NCT00773136|O2|Outcome|Control Group|Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye.
1017585|NCT00773136|O1|Outcome|Bimatoprost Mixed With Gonak Into a Gel Suspension|Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye.
1017586|NCT00773136|E1|Reported Event|Bimatoprost Mixed With Gonak Into a Gel Suspension|Each subject was given two suspensions, one of Bimatoprost mixed with Gonak into a gel suspension and one with Gonak mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The solution vials were labeled right or left eye.
1017587|NCT00773097|B1|Baseline|MUC1 Poly-ICLC|MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
1017588|NCT00773097|P1|Participant Flow|MUC1 Poly-ICLC|MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
1017589|NCT00773097|O1|Outcome|MUC1 Poly-ICLC|MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
1017590|NCT00773097|O1|Outcome|MUC1 Poly-ICLC|MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
1017591|NCT00773097|O1|Outcome|MUC1 Poly-ICLC|MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
1017592|NCT00773097|E1|Reported Event|MUC1 Poly-ICLC|MUC1 - Poly ICLC : The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
1017593|NCT00772967|B1|Baseline|All Participants|All randomized participants
1017594|NCT00772967|P6|Participant Flow|Ultracet, Naproxen, Placebo|Ultracet in Treatment Period 1, Naproxen in Treatment Period 2, Placebo in Treatment Period 3.
1017595|NCT00772967|P5|Participant Flow|Naproxen, Placebo, Ultracet|Naproxen in Treatment Period 1, Placebo in Treatment Period 2, Ultracet inTreatment Period 3.
1017596|NCT00772967|P4|Participant Flow|Placebo, Ultracet, Naproxen|Placebo in Treatment Period 1, Ultracet in Treatment Period 2, Naproxen in Treatment Period 3.
1017597|NCT00772967|P3|Participant Flow|Ultracet, Placebo, Naproxen|Ultracet in Treatment Period 1, Placebo in Treatment Period 2, Naproxen in Treatment Period 3.
1017598|NCT00772967|P2|Participant Flow|Naproxen, Ultracet, Placebo|Naproxen in Treatment Period 1, Ultracet in Treatment Period 2, Placebo in Treatment Period 3.
1017599|NCT00772967|P1|Participant Flow|Placebo, Naproxen, Ultracet|Placebo in Treatment Period 1, Naproxen in Treatment Period 2, Ultracet in Treatment Period 3.
1017600|NCT00772967|O3|Outcome|Ultracet|Participants treated with at least one dose of Ultracet.
1017601|NCT00772967|O2|Outcome|Naproxen|Participants treated with at least one dose of Naproxen
1017602|NCT00772967|O1|Outcome|Placebo|Participants treated with at least one dose of Placebo
1017603|NCT00772967|O3|Outcome|Ultracet|Participants treated with at least one dose of Ultracet.
1017604|NCT00772967|O2|Outcome|Naproxen|Participants treated with at least one dose of Naproxen
1017605|NCT00772967|O1|Outcome|Placebo|Participants treated with at least one dose of Placebo
1017606|NCT00772967|O3|Outcome|Ultracet|Participants treated with at least one dose of Ultracet.
1017607|NCT00772967|O2|Outcome|Naproxen|Participants treated with at least one dose of Naproxen
1017608|NCT00772967|O1|Outcome|Placebo|Participants treated with at least one dose of Placebo
1017609|NCT00772967|O3|Outcome|Ultracet|Participants treated with at least one dose of Ultracet.
1017610|NCT00772967|O2|Outcome|Naproxen|Participants treated with at least one dose of Naproxen
1017611|NCT00772967|O1|Outcome|Placebo|Participants treated with at least one dose of Placebo
1017612|NCT00772967|E3|Reported Event|Ultracet|Participants treated with at least one dose of Ultracet. Two participants were not treated due to discontinuation.
1017613|NCT00772967|E2|Reported Event|Naproxen|Participants treated with at least one dose of Naproxen
1017614|NCT00772967|E1|Reported Event|Placebo|Participants treated with at least one dose of Placebo
1017615|NCT00772954|B4|Baseline|Total|Total of all reporting groups
1017616|NCT00772954|B3|Baseline|Clostridium Difficile Toxoid Vaccine Group 2|Participants received a dose of 100 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
1017617|NCT00772954|B2|Baseline|Clostridium Difficile Toxoid Vaccine Group 1|Participants received a dose of 50 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
1017618|NCT00772954|B1|Baseline|Placebo Vaccine Group|Participants received a dose of placebo (vaccine diluent) on Day 0 and Day 28.
1017619|NCT00772954|P3|Participant Flow|Clostridium Difficile Toxoid Vaccine Group 2|Participants received a dose of 100 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
1017620|NCT00772954|P2|Participant Flow|Clostridium Difficile Toxoid Vaccine Group 1|Participants received a dose of 50 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
1017621|NCT00772954|P1|Participant Flow|Placebo Vaccine Group|Participants received a dose of placebo (vaccine diluent) on Day 0 and Day 28.
1017622|NCT00772954|O3|Outcome|Clostridium Difficile Toxoid Vaccine Group 2|Participants received a dose of 100 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
1017623|NCT00772954|O2|Outcome|Clostridium Difficile Toxoid Vaccine Group 1|Participants received a dose of 50 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
1017624|NCT00772954|O1|Outcome|Placebo Vaccine Group|Participants received a dose of placebo (vaccine diluent) on Day 0 and Day 28.
1017625|NCT00772954|E3|Reported Event|Clostridium Difficile Toxoid Vaccine Group 2|Participants received a dose of 100 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
1017626|NCT00772954|E2|Reported Event|Clostridium Difficile Toxoid Vaccine Group 1|Participants received a dose of 50 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
1017627|NCT00772954|E1|Reported Event|Placebo Vaccine Group|Participants received a dose of placebo (vaccine diluent) on Day 0 and Day 28.
1017628|NCT00772941|B1|Baseline|Varenicline|Participants taking Varenicline according to Japanese Package Insert.
1017629|NCT00772941|P1|Participant Flow|Varenicline|Participants taking Varenicline according to Japanese Package Insert.
1017630|NCT00772941|O1|Outcome|Varenicline|Participants taking Varenicline according to Japanese Package Insert.
1017631|NCT00772941|O1|Outcome|Varenicline|Participants taking Varenicline according to Japanese Package Insert.
1017632|NCT00772941|O1|Outcome|Varenicline|Participants taking Varenicline according to Japanese Package Insert.
1017633|NCT00772941|O2|Outcome|Varenicline - Without Antipsychotics as a Concomitant Drug|Varenicline without Antipsychotics as a Concomitant Drug
1017634|NCT00772941|O1|Outcome|Varenicline - With Antipsychotics as a Concomitant Drug|Varenicline with Antipsychotics as a Concomitant Drug
1017635|NCT00772941|O2|Outcome|Administration Not Prolonged After 12 Weeks|Participants without prolonged administration of Varenicline after 12 weeks according to Japanese Package Insert.
1017636|NCT00772941|O1|Outcome|Administration Prolonged After 12 Weeks|Participants with prolonged administration of Varenicline after 12 weeks according to Japanese Package Insert.
1017637|NCT00772941|O3|Outcome|>=41 Cigarettes Per Day|Participants with >=41 cigarettes per day during treatment with Varenicline according to Japanese Package Insert.
1017638|NCT00772941|O2|Outcome|>=21 and <=40 Cigarettes Per Day|Participants with >=21 and <=40 cigarettes per day during treatment with Varenicline according to Japanese Package Insert.
1017639|NCT00772941|O1|Outcome|<=20 Cigarettes Per Day|Participants with <=20 cigarettes per day during treatment with Varenicline according to Japanese Package Insert.
1017640|NCT00772941|O6|Outcome|>= 80 kg at Baseline|Participants whose weights at baseline were more than or equal to 80 kg.
1017641|NCT00772941|O5|Outcome|>=70 kg and <80 kg at Baseline|Participants whose weights at baseline were more than or equal to 70 kg and less than 80 kg.
1017642|NCT00772941|O4|Outcome|>=60 kg and <70 kg at Baseline|Participants whose weights at baseline were more than or equal to 60 kg and less than 70 kg.
1017643|NCT00772941|O3|Outcome|>=50 kg and <60 kg at Baseline|Participants whose weights at baseline were more than or equal to 50 kg and less than 60 kg.
1017644|NCT00772941|O2|Outcome|>=40 kg and <50 kg at Baseline|Participants whose weights at baseline were more than or equal to 40 kg and less than 50 kg.
1017645|NCT00772941|O1|Outcome|<40 kg at Baseline|Participants whose weights at baseline were less than 40 kg.
1017646|NCT00772941|O2|Outcome|Varenicline - Without Concomitant Therapies|Participants receiving no concomitant therapies while taking Varenicline according to Japanese Package Insert.
1017647|NCT00772941|O1|Outcome|Varenicline - With Concomitant Therapies|Participants receiving concomitant therapies while taking Varenicline according to Japanese Package Insert.
1017648|NCT00772941|O2|Outcome|Varenicline - Without Concomitant Drugs|Participants taking no concomitant drugs while taking Varenicline according to Japanese Package Insert.
1017649|NCT00772941|O1|Outcome|Varenicline - With Concomitant Drugs|Participants taking concomitant drugs while taking Varenicline according to Japanese Package Insert.
1017650|NCT00772941|O2|Outcome|Varenicline - Without Chronic Obstructive Pulmonary Disease|Participants without chronic obstructive pulmonary disease as a complication taking Varenicline according to Japanese Package Insert.
1017651|NCT00772941|O1|Outcome|Varenicline - With Chronic Obstructive Pulmonary Disease|Participants with chronic obstructive pulmonary disease as a complication taking Varenicline according to Japanese Package Insert.
1017652|NCT00772941|O2|Outcome|>=65 Years|Participants with >=65 years taking Varenicline according to Japanese Package Insert.
1017653|NCT00772941|O1|Outcome|<65 Years|Participants with <65 years taking Varenicline according to Japanese Package Insert.
1017654|NCT00772941|O2|Outcome|Female|Female participants taking Varenicline according to Japanese Package Insert.
1017655|NCT00772941|O1|Outcome|Male|Male participants taking Varenicline according to Japanese Package Insert.
1017656|NCT00772941|E1|Reported Event|Varenicline|Participants taking Varenicline according to Japanese Package Insert.
1017657|NCT00772928|B3|Baseline|Total|Total of all reporting groups
1017658|NCT00772928|B2|Baseline|Pentacel™ Staggered Schedule With Prevnar®|Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
1017659|NCT00772928|B1|Baseline|Pentacel™ Concurrently With Prevnar®|Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine
1017660|NCT00772928|P2|Participant Flow|Pentacel™ Staggered Schedule With Prevnar®|Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
1017661|NCT00772928|P1|Participant Flow|Pentacel™ Concurrently With Prevnar®|Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine
1017662|NCT00772928|O2|Outcome|Pentacel™ Staggered Schedule With Prevnar®|Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
1017663|NCT00772928|O1|Outcome|Pentacel™ Concurrently With Prevnar®|Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine
1017664|NCT00772928|O2|Outcome|Pentacel™ Staggered Schedule With Prevnar®|Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
1017665|NCT00772928|O1|Outcome|Pentacel™ Concurrently With Prevnar®|Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine
1017666|NCT00772928|O2|Outcome|Pentacel™ Staggered Schedule With Prevnar®|Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
1017668|NCT00772928|E2|Reported Event|Pentacel™ Staggered Schedule With Prevnar®|Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
1017669|NCT00772928|E1|Reported Event|Pentacel™ Concurrently With Prevnar®|Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine
1017670|NCT00772915|B1|Baseline|Lenalidomide With On-Demand Dexamethasone|"Lenalidmoide: 25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles. >~> Dexamethasone: 10-40 mg once weekly (days 1, 8, 15, & 22) orally with food until progression."
1017671|NCT00772915|P1|Participant Flow|Lenalidomide With On-Demand Dexamethasone|"Lenalidmoide: 25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles. >~> Dexamethasone: 10-40 mg once weekly (days 1, 8, 15, & 22) orally with food until progression."
1017672|NCT00772915|O1|Outcome|Lenalidomide With On-Demand Dexamethasone|"Lenalidmoide: 25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles.~Dexamethasone: 10-40 mg once weekly (days 1, 8, 15, & 22) orally with food until progression."
1017673|NCT00772915|E1|Reported Event|Lenalidomide With On-Demand Dexamethasone|Dexamethasone: 10-40 mg once weekly (days 1, 8, 15, & 22) orally with food until progression.
1017674|NCT00772889|B4|Baseline|Total|Total of all reporting groups
1017675|NCT00772889|B3|Baseline|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
1017676|NCT00772889|B2|Baseline|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
1017677|NCT00772889|B1|Baseline|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
1017678|NCT00772889|P3|Participant Flow|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
1017679|NCT00772889|P2|Participant Flow|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
1017680|NCT00772889|P1|Participant Flow|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
1017681|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
1017682|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
1017683|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
1017684|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
1017685|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
1017686|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
1017687|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
1017688|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
1017689|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
1017690|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
1017691|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
1017692|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
1017693|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
1017694|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
1017695|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
1017696|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
1017697|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
1017698|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
1017699|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
1017700|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
1017701|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
1017702|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
1017703|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
1017704|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
1017705|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
1017706|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
1017707|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
1017708|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
1017709|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
1017710|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
1017711|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
1017712|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
1017713|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
1017716|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
1017717|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
1017718|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
1017719|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
1017720|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
1017721|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
1017722|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
1017723|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
1017724|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
1017725|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
1017726|NCT00772889|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
1017727|NCT00772889|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
1017728|NCT00772889|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
1017729|NCT00772889|E3|Reported Event|Fluarix Young Group|Subjects aged 19-43 years received one dose of Fluarix vaccine.
1017730|NCT00772889|E2|Reported Event|Fluarix Elderly Group|Subjects aged ≥66 years received one dose of Fluarix vaccine.
1017731|NCT00772889|E1|Reported Event|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.
1017732|NCT00772772|B1|Baseline|Vitamin D3|
1017733|NCT00772772|P1|Participant Flow|Vitamin D3|Vitamin D3 30,000 units PO weekly for 8 weeks
1017734|NCT00772772|O1|Outcome|CKD Patients|
1017735|NCT00772772|O1|Outcome|Patients With Chronic Kidney Disease (CKD)|CKD patients who were Vitamin D deficient and received Vitamin D3 repletion
1017736|NCT00772772|E1|Reported Event|Vitamin D3|
1017737|NCT00772707|B1|Baseline|Opti-Free Replenish|Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
1017738|NCT00772707|P1|Participant Flow|Opti-Free Replenish|Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
1017739|NCT00772707|O1|Outcome|Opti-Free Replenish|Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
1017740|NCT00772707|O1|Outcome|Opti-Free Replenish|Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
1017741|NCT00772707|E1|Reported Event|Opti-Free Replenish|Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
1017742|NCT00772668|B1|Baseline|RCVELP|"Bortezomib : 1.6 mg/m2 IV push over 3-5 seconds on Days 1 and 8 of every 21 days cycle for 8 cycles~Cyclophosphamide : 750 mg/m2 IVPB over 30 minuntes on Day 1 of every 21 day cycle for 8 cycles~Prednisone : 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles~Rituximab : 375 mg/m2 IV infusion at 50 mg/hr on Day 1 of every 21 days cycle for 8 cycles"
1017743|NCT00772668|P1|Participant Flow|RCVELP|"Bortezomib : 1.6 mg/m2 IV push over 3-5 seconds on Days 1 and 8 of every 21 days cycle for 8 cycles~Cyclophosphamide : 750 mg/m2 IVPB over 30 minuntes on Day 1 of every 21 day cycle for 8 cycles~Prednisone : 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles~Rituximab : 375 mg/m2 IV infusion at 50 mg/hr on Day 1 of every 21 days cycle for 8 cycles"
1017744|NCT00772668|O1|Outcome|RCVELP|"Bortezomib : 1.6 mg/m2 IV push over 3-5 seconds on Days 1 and 8 of every 21 days cycle for 8 cycles~Cyclophosphamide : 750 mg/m2 IVPB over 30 minuntes on Day 1 of every 21 day cycle for 8 cycles~Prednisone : 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles~Rituximab : 375 mg/m2 IV infusion at 50 mg/hr on Day 1 of every 21 days cycle for 8 cycles"
1017745|NCT00772668|E1|Reported Event|RCVELP|"Bortezomib : 1.6 mg/m2 IV push over 3-5 seconds on Days 1 and 8 of every 21 days cycle for 8 cycles~Cyclophosphamide : 750 mg/m2 IVPB over 30 minuntes on Day 1 of every 21 day cycle for 8 cycles~Prednisone : 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles~Rituximab : 375 mg/m2 IV infusion at 50 mg/hr on Day 1 of every 21 days cycle for 8 cycles"
1017746|NCT00772629|B3|Baseline|Total|Total of all reporting groups
1017747|NCT00772629|B2|Baseline|Meningococcal Vaccine-primed Group|Participants who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135
1017748|NCT00772629|B1|Baseline|Meningococcal Vaccine-naive Group|Participants have never received any meningococcal vaccine in the past
1017749|NCT00772629|P2|Participant Flow|Meningococcal Vaccine-primed Group|Participants who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135
1017750|NCT00772629|P1|Participant Flow|Meningococcal Vaccine-naive Group|Participants have never received any meningococcal vaccine in the past
1017751|NCT00772629|O2|Outcome|Meningococcal Vaccine-primed Group|Participants who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135
1017752|NCT00772629|O1|Outcome|Meningococcal Vaccine-naive Group|Participants have never received any meningococcal vaccine in the past
1017753|NCT00772629|E2|Reported Event|Meningococcal Vaccine-primed Group|Participants who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135
1017754|NCT00772629|E1|Reported Event|Meningococcal Vaccine-naive Group|Participants have never received any meningococcal vaccine in the past
1017755|NCT00772603|B4|Baseline|Total|Total of all reporting groups
1017756|NCT00772603|B3|Baseline|Placebo|Placebo given once daily.
1017757|NCT00772603|B2|Baseline|1200mg/Day SPN-804|1200mg SPN-804O given once daily
1017758|NCT00772603|B1|Baseline|2400mg/Day SPN-804|2400mg SPN-804O once daily
1017777|NCT00772603|E3|Reported Event|Placebo|placebo QD, given as four placebo tablets
1017778|NCT00772603|E2|Reported Event|1200mg/Day SPN-804|1200mg total daily dose of SPN-804O QD, given as two 600mg tablets and two identical placebo tablets.
1017779|NCT00772603|E1|Reported Event|2400mg/Day SPN-804|2400mg total daily dose of SPN-804O once a day (QD), given as four 600mg tablets
1017780|NCT00772590|B5|Baseline|Total|Total of all reporting groups
1017781|NCT00772590|B4|Baseline|Placebo|Raltegravir placebo and hyper-immune bovine colostrum placebo
1017782|NCT00772590|B3|Baseline|Raltegravir|Raltegravir and Hyper-immune Bovine Colostrum placebo
1017783|NCT00772590|B2|Baseline|Hyper-immune Bovine Colostrum|Hyper-immune bovine colostrum and Raltegravir placebo
1017784|NCT00772590|B1|Baseline|Raltegravir + Hyper-immune Bovine Colostrum|Raltegravir and hyper-immune bovine colostrum
1017785|NCT00772590|P4|Participant Flow|Placebo|Raltegravir placebo and hyper-immune bovine colostrum placebo
1017786|NCT00772590|P3|Participant Flow|Raltegravir|Raltegravir and Hyper-immune Bovine Colostrum placebo
1017787|NCT00772590|P2|Participant Flow|Hyper-immune Bovine Colostrum|Hyper-immune bovine colostrum and Raltegravir placebo
1017788|NCT00772590|P1|Participant Flow|Raltegravir + Hyper-immune Bovine Colostrum|Raltegravir and hyper-immune bovine colostrum
1017789|NCT00772590|O4|Outcome|Placebo|Raltegravir placebo and hyper-immune bovine colostrum placebo
1017790|NCT00772590|O3|Outcome|Raltegravir|Raltegravir and Hyper-immune Bovine Colostrum placebo
1017791|NCT00772590|O2|Outcome|Hyper-immune Bovine Colostrum|Hyper-immune bovine colostrum and Raltegravir placebo
1017792|NCT00772590|O1|Outcome|Raltegravir + Hyper-immune Bovine Colostrum|Raltegravir and hyper-immune bovine colostrum
1017793|NCT00772590|E4|Reported Event|Placebo|Raltegravir placebo and hyper-immune bovine colostrum placebo
1017794|NCT00772590|E3|Reported Event|Raltegravir|Raltegravir and Hyper-immune Bovine Colostrum placebo
1017795|NCT00772590|E2|Reported Event|Hyper-immune Bovine Colostrum|Hyper-immune bovine colostrum and Raltegravir placebo
1017796|NCT00772590|E1|Reported Event|Raltegravir + Hyper-immune Bovine Colostrum|Raltegravir and hyper-immune bovine colostrum
1017797|NCT00772577|B3|Baseline|Total|Total of all reporting groups
1017798|NCT00772577|B2|Baseline|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
1017799|NCT00772577|B1|Baseline|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
1017800|NCT00772577|P2|Participant Flow|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
1017801|NCT00772577|P1|Participant Flow|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
1017802|NCT00772577|O2|Outcome|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
1017803|NCT00772577|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
1017804|NCT00772577|O2|Outcome|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
1017805|NCT00772577|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
1017806|NCT00772577|O2|Outcome|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
1017807|NCT00772577|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
1017808|NCT00772577|O2|Outcome|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
1017809|NCT00772577|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
1017810|NCT00772577|O2|Outcome|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
1017811|NCT00772577|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
1017812|NCT00772577|E2|Reported Event|Ramipril|Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
1017813|NCT00772577|E1|Reported Event|Aliskiren HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks
1017814|NCT00772538|B3|Baseline|Total|Total of all reporting groups
1017815|NCT00772538|B2|Baseline|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017816|NCT00772538|B1|Baseline|Placebo|Patients treated with matching placebo
1017817|NCT00772538|P2|Participant Flow|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017818|NCT00772538|P1|Participant Flow|Placebo|Patients treated with matching placebo
1017819|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017820|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
1017821|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017822|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
1017823|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017824|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
1017825|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017826|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
1017827|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017828|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
1017829|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017830|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
1017831|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017832|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
1017833|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017834|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
1017835|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017836|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
1017837|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017838|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
1017839|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017840|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
1017841|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017842|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
1017843|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017844|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
1017845|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017846|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
1017847|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017848|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
1017849|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017850|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
1017851|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017852|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
1017853|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017854|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
1017855|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017856|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
1017857|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017858|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
1017859|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017860|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
1017861|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017862|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
1017863|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017864|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
1017865|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017866|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
1017867|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017868|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
1017869|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017870|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
1017871|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017872|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
1017873|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017874|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
1017875|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017876|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
1017877|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017878|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
1017879|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017880|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
1017881|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017882|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
1017883|NCT00772538|O2|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
1017884|NCT00772538|O1|Outcome|Placebo|Patients treated with matching placebo
1017885|NCT00772538|E2|Reported Event|Tio R5|Patients treated with tiotropium inhalation solution 5 Î¼g qd
1017886|NCT00772538|E1|Reported Event|Placebo|Patients treated with matching placebo
1017887|NCT00772447|B3|Baseline|Total|Total of all reporting groups
1017888|NCT00772447|B2|Baseline|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
1017889|NCT00772447|B1|Baseline|Daptomycin|daptomycin 4mg/kg iv every 24hours
1017890|NCT00772447|P2|Participant Flow|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
1017891|NCT00772447|P1|Participant Flow|Daptomycin|daptomycin 4mg/kg iv every 24hours
1017892|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
1017893|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
1017894|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
1017895|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
1017896|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
1017897|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
1017898|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
1017899|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
1017900|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
1017901|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
1018014|NCT00772031|O2|Outcome|Topiramate Plus Placebo|Participants will receive placebo and topiramate.
1017902|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hrs, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
1017903|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
1017904|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
1017905|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
1017906|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hrs, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
1017907|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
1017908|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
1017909|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
1017910|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
1017911|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
1017912|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
1017913|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
1017914|NCT00772447|O2|Outcome|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
1017915|NCT00772447|O1|Outcome|Daptomycin|daptomycin 4mg/kg iv every 24hours
1017916|NCT00772447|E2|Reported Event|Vancomycin, or Vancomycin Switch to Cloxacillin|vancomycin 1g per 12 hours, for 7-14 days; or switch to cloxacillin: 1 g every 6 hours or 2 g every 8 hours
1017917|NCT00772447|E1|Reported Event|Daptomycin|daptomycin 4mg/kg iv every 24hours
1017918|NCT00772382|B1|Baseline|MCI-196|3, 6, 9, 12, or 15 g/ day as titrated
1017919|NCT00772382|P1|Participant Flow|MCI-196|3, 6, 9, 12, or 15 g/ day as titrated
1017920|NCT00772382|O1|Outcome|MCI-196|3, 6, 9, 12, or 15 g/ day as titrated
1017921|NCT00772382|O1|Outcome|MCI-196|3, 6, 9, 12, or 15 g/ day as titrated
1017922|NCT00772382|E1|Reported Event|MCI-196|3, 6, 9, 12, or 15 g/ day as titrated
1017923|NCT00772369|B1|Baseline|Study Group|Received 4th dose of the Pentacel® series before 2nd birthday
1017924|NCT00772369|P1|Participant Flow|Study Group|Received 4th dose of the Pentacel® series before 2nd birthday
1017925|NCT00772369|O1|Outcome|Study Group|Received 4th dose of the Pentacel® series before 2nd birthday
1017926|NCT00772369|O1|Outcome|Study Group|Received 4th dose of the Pentacel® series before 2nd birthday
1017927|NCT00772369|E1|Reported Event|Study Group|Received 4th dose of the Pentacel® series before 2nd birthday
1017928|NCT00772304|B1|Baseline|Olopatadine 0.6% / Azelastine 137 Mcg|Olopatadine 0.6% / Azelastine 137 mcg
1017929|NCT00772304|P1|Participant Flow|Olopatadine 0.6% / Azelastine 137 Mcg|Olopatadine 0.6% / Azelastine 137 mcg
1017930|NCT00772304|O1|Outcome|Olopatadine 0.6% / Azelastine 137 Mcg|Olopatadine 0.6% / Azelastine 137 mcg
1017931|NCT00772304|E1|Reported Event|Olopatadine 0.6% / Azelastine 137 Mcg|Olopatadine 0.6% / Azelastine 137 mcg
1017932|NCT00772148|B3|Baseline|Total|Total of all reporting groups
1017933|NCT00772148|B2|Baseline|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
1017934|NCT00772148|B1|Baseline|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
1017935|NCT00772148|P2|Participant Flow|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
1017936|NCT00772148|P1|Participant Flow|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
1017937|NCT00772148|O2|Outcome|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
1017938|NCT00772148|O1|Outcome|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
1017939|NCT00772148|O2|Outcome|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
1024990|NCT00758459|O1|Outcome|AZD1236|AZD1236
1017940|NCT00772148|O1|Outcome|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
1017941|NCT00772148|O2|Outcome|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
1017942|NCT00772148|O1|Outcome|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
1017943|NCT00772148|O2|Outcome|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
1017944|NCT00772148|O1|Outcome|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
1017945|NCT00772148|O2|Outcome|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
1017946|NCT00772148|O1|Outcome|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
1017947|NCT00772148|O2|Outcome|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
1017948|NCT00772148|O1|Outcome|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
1017949|NCT00772148|E2|Reported Event|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral Prograf capsules will be administered starting at 0.10 – 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)"
1017950|NCT00772148|E1|Reported Event|LCP-Tacro|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 – 0.11 mg/kg. The starting dose for African-American patients will be 0.09 – 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 – 20 ng/mL.~Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)"
1017951|NCT00772109|B5|Baseline|Total|Total of all reporting groups
1017952|NCT00772109|B4|Baseline|Fluzone Intramuscular (IM) Vaccine|Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
1017953|NCT00772109|B3|Baseline|Fluzone Intradermal (ID) Vaccine Lot 3|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
1017954|NCT00772109|B2|Baseline|Fluzone Intradermal (ID) Vaccine Lot 2|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
1017955|NCT00772109|B1|Baseline|Fluzone Intradermal (ID) Vaccine Lot 1|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
1017956|NCT00772109|P4|Participant Flow|Fluzone Intramuscular (IM) Vaccine|Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
1017957|NCT00772109|P3|Participant Flow|Fluzone Intradermal (ID) Vaccine Lot 3|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
1017958|NCT00772109|P2|Participant Flow|Fluzone Intradermal (ID) Vaccine Lot 2|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
1017959|NCT00772109|P1|Participant Flow|Fluzone Intradermal (ID) Vaccine Lot 1|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
1017960|NCT00772109|O4|Outcome|Fluzone Intramuscular (IM) Vaccine|Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
1017961|NCT00772109|O3|Outcome|Fluzone Intradermal (ID) Vaccine Lot 3|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
1017962|NCT00772109|O2|Outcome|Fluzone Intradermal (ID) Vaccine Lot 2|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
1017963|NCT00772109|O1|Outcome|Fluzone Intradermal (ID) Vaccine Lot 1|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
1018719|NCT00771953|O1|Outcome|Apricoxib Plus Docetaxel|Apricoxib 400mg qd plus docetaxel 75mg/m2 q21 days
1017964|NCT00772109|O4|Outcome|Fluzone Intramuscular (IM) Vaccine|Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
1017965|NCT00772109|O3|Outcome|Fluzone Intradermal (ID) Vaccine Lot 3|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
1017966|NCT00772109|O2|Outcome|Fluzone Intradermal (ID) Vaccine Lot 2|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
1017967|NCT00772109|O1|Outcome|Fluzone Intradermal (ID) Vaccine Lot 1|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
1017968|NCT00772109|O4|Outcome|Fluzone Intramuscular (IM) Vaccine|Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
1017969|NCT00772109|O3|Outcome|Fluzone Intradermal (ID) Vaccine Lot 3|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
1017970|NCT00772109|O2|Outcome|Fluzone Intradermal (ID) Vaccine Lot 2|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
1017971|NCT00772109|O1|Outcome|Fluzone Intradermal (ID) Vaccine Lot 1|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
1017972|NCT00772109|O4|Outcome|Fluzone Intramuscular (IM) Vaccine|Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
1017973|NCT00772109|O3|Outcome|Fluzone Intradermal (ID) Vaccine Lot 3|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
1017974|NCT00772109|O2|Outcome|Fluzone Intradermal (ID) Vaccine Lot 2|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
1017975|NCT00772109|O1|Outcome|Fluzone Intradermal (ID) Vaccine Lot 1|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
1017976|NCT00772109|E4|Reported Event|Fluzone Intramuscular (IM) Vaccine|Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
1017977|NCT00772109|E3|Reported Event|Fluzone Intradermal (ID) Vaccine Lot 3|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
1017978|NCT00772109|E2|Reported Event|Fluzone Intradermal (ID) Vaccine Lot 2|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
1017979|NCT00772109|E1|Reported Event|Fluzone Intradermal (ID) Vaccine Lot 1|Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
1017980|NCT00772070|B3|Baseline|Total|Total of all reporting groups
1017981|NCT00772070|B2|Baseline|Meningococcal Vaccine-naive|Participants have never received a Meningococcal vaccine in the past.
1017982|NCT00772070|B1|Baseline|Previously Received TetraMenD|Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
1017983|NCT00772070|P2|Participant Flow|Meningococcal Vaccine-naive|Participants have never received a Meningococcal vaccine in the past.
1017984|NCT00772070|P1|Participant Flow|Previously Received TetraMenD|Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
1017985|NCT00772070|O2|Outcome|Meningococcal Vaccine-naive|Participants have never received a Meningococcal vaccine in the past.
1017986|NCT00772070|O1|Outcome|Previously Received TetraMenD|Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
1017987|NCT00772070|O2|Outcome|Meningococcal Vaccine-naive|Participants have never received a Meningococcal vaccine in the past.
1017988|NCT00772070|O1|Outcome|Previously Received TetraMenD|Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
1017989|NCT00772070|O2|Outcome|Meningococcal Vaccine-naive|Participants have never received a Meningococcal vaccine in the past.
1017990|NCT00772070|O1|Outcome|Previously Received TetraMenD|Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
1017991|NCT00772070|E2|Reported Event|Meningococcal Vaccine-naive|Participants have never received a Meningococcal vaccine in the past.
1017992|NCT00772070|E1|Reported Event|Previously Received TetraMenD|Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
1017993|NCT00772031|B3|Baseline|Total|Total of all reporting groups
1017994|NCT00772031|B2|Baseline|Topiramate Plus Placebo|Participants will receive a placebo and topiramate.
1017995|NCT00772031|B1|Baseline|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
1017996|NCT00772031|P2|Participant Flow|Topiramate Plus Placebo|Participants will receive a placebo and topiramate.
1017997|NCT00772031|P1|Participant Flow|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
1017998|NCT00772031|O2|Outcome|Topiramate Plus Placebo|Participants will receive a placebo and topiramate.
1017999|NCT00772031|O1|Outcome|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
1018000|NCT00772031|O4|Outcome|Topiramate Plus Placebo, Prior, Stable Topiramate|Participants with prior stable topiramate use received a placebo and topiramate.
1018001|NCT00772031|O3|Outcome|Topiramate Plus Propranolol, Prior, Stable Topiramate|Participants with prior stable topiramate use received propranolol and topiramate.
1018002|NCT00772031|O2|Outcome|Topiramate Plus Placebo, no Prior, Stable Topiramate|Participants without prior stable topiramate use received a placebo and topiramate.
1018003|NCT00772031|O1|Outcome|Topiramate Plus Propranolol, no Prior, Stable Topiramate|Participants without prior stable topiramate use received propranolol and topiramate.
1018004|NCT00772031|O2|Outcome|Topiramate Plus Placebo|Participants will receive a placebo and topiramate.
1018005|NCT00772031|O1|Outcome|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
1018006|NCT00772031|O2|Outcome|Topiramate Plus Placebo|Participants will receive a placebo and topiramate.
1018007|NCT00772031|O1|Outcome|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
1018008|NCT00772031|O2|Outcome|Topiramate Plus Placebo|Participants will receive a placebo and topiramate.
1018009|NCT00772031|O1|Outcome|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
1018010|NCT00772031|O2|Outcome|Topiramate Plus Placebo|Participants will receive placebo and topiramate.
1018011|NCT00772031|O1|Outcome|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
1018012|NCT00772031|O2|Outcome|Topiramate Plus Placebo|Participants will receive placebo and topiramate.
1018013|NCT00772031|O1|Outcome|Topiramate Plus Proporanolol|Participants will receive propranolol and topiramate.
1018015|NCT00772031|O1|Outcome|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
1018016|NCT00772031|E2|Reported Event|Topiramate Plus Placebo|Participants will receive a placebo and topiramate.
1018017|NCT00772031|E1|Reported Event|Topiramate Plus Propranolol|Participants will receive propranolol and topiramate.
1018018|NCT00772005|B5|Baseline|Total|Total of all reporting groups
1018019|NCT00772005|B4|Baseline|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018020|NCT00772005|B3|Baseline|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018021|NCT00772005|B2|Baseline|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018022|NCT00772005|B1|Baseline|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018023|NCT00772005|P4|Participant Flow|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018024|NCT00772005|P3|Participant Flow|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018025|NCT00772005|P2|Participant Flow|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018026|NCT00772005|P1|Participant Flow|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018027|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018028|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018029|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1024991|NCT00758459|O2|Outcome|Placebo|Placebo
1018030|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018031|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018032|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018033|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018034|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018035|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018036|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018037|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018038|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018039|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018040|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018720|NCT00771953|E2|Reported Event|Placebo Plus Docetaxel or Pemetrexed|Placebo and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
1018721|NCT00771953|E1|Reported Event|Apricoxib Plus Docetaxel or Pemetrexed|Apricoxib 400mg qd and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
1018722|NCT00771927|B3|Baseline|Total|Total of all reporting groups
1019026|NCT00771667|O3|Outcome|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
1018041|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018042|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018043|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018044|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018045|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018046|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018047|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018048|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018049|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018050|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018051|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018723|NCT00771927|B2|Baseline|Other AED|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy
1018724|NCT00771927|B1|Baseline|Lacosamide|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat
1018725|NCT00771927|P2|Participant Flow|Other AED|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy
1018052|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018053|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018054|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018055|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018056|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018057|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018058|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018059|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018060|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018061|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018062|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018726|NCT00771927|P1|Participant Flow|Lacosamide|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat
1018727|NCT00771927|O2|Outcome|Other AED|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy
1018728|NCT00771927|O1|Outcome|Lacosamide|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat
1018063|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018064|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018065|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018066|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018067|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018068|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018069|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018070|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018071|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018072|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018073|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018729|NCT00771927|O2|Outcome|Other AED|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy
1018730|NCT00771927|O1|Outcome|Lacosamide|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat
1018731|NCT00771927|E2|Reported Event|Other AED|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy
1018074|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018075|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018076|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018077|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018078|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018079|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018080|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018081|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018082|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018083|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018084|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018732|NCT00771927|E1|Reported Event|Lacosamide|Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat
1018733|NCT00771914|B5|Baseline|Total|Total of all reporting groups
1018734|NCT00771914|B4|Baseline|Both Aspirin and Lovaza, Placebo, Lovaza, Aspirin|First both 81mg of Aspirin and 4 grams of Lovaza, then Placebo, then 4 grams of Lovaza, then 81mg of Aspirin
1019930|NCT00769561|E1|Reported Event|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
1018085|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018086|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018087|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018088|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018089|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018090|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018091|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018092|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018093|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018094|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018095|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018735|NCT00771914|B3|Baseline|Lovaza, Both Aspirin and Lovaza, Placebo, Aspirin|First 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then Placebo, then 81mg of Aspirin
1018736|NCT00771914|B2|Baseline|Aspirin, Lovaza, Both Aspirin and Lovaza, Placebo|First 81mg of Aspirin, then 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo
1018737|NCT00771914|B1|Baseline|Placebo, Lovaza, Aspirin, Both Aspirin and Lovaza|First Placebo, then 4 grams of Lovaza, then 81 mg of aspirin, then both 81mg of Aspirin and 4 grams of Lovaza
1018096|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018097|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018098|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018099|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018100|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018101|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018102|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018103|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018104|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018105|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018106|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018738|NCT00771914|P4|Participant Flow|Both Aspirin and Lovaza, Placebo, Lovaza, Aspirin|First both 81mg of Aspirin and 4 grams of Lovaza, then placebo, then 4 grams of Lovaza, then 81mg of Aspirin
1018739|NCT00771914|P3|Participant Flow|Lovaza, Both Aspirin and Lovaza, Placebo, Aspirin|First 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo, then 81 mg of Aspirin
1019027|NCT00771667|O2|Outcome|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
1018107|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018108|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018109|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018110|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018111|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018112|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018113|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018114|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018115|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018116|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018117|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018740|NCT00771914|P2|Participant Flow|Aspirin, Lovaza, Both Aspirin and Lovaza, Placebo|First 81mg of Aspirin, then both 81mg of Aspirin and 4 grams of Lovaza, then 4 grams of Lovaza, then 81mg of Aspirin
1018741|NCT00771914|P1|Participant Flow|Placebo, Lovaza, Aspirin, Both Aspirin and Lovaza|First Placebo, then 4 grams of Lovaza, then 81mg of Aspirin, then both 81mg of Aspirin and 4 grams of Lovaza
1018742|NCT00771914|O4|Outcome|Both Aspirin and Lovaza|All participants received Aspirin and Lovaza intervention regardless of sequence.
1018118|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018119|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018120|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018121|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018122|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018123|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018124|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018125|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018126|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018127|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018128|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018743|NCT00771914|O3|Outcome|Lovaza|All participants received Lovaza intervention regardless of sequence.
1018744|NCT00771914|O2|Outcome|Aspirin|All participants received Aspirin intervention regardless of sequence.
1018745|NCT00771914|O1|Outcome|Placebo|All participants received Placebo intervention regardless of sequence.
1018746|NCT00771914|E4|Reported Event|Both Aspirin and Lovaza, Placebo, Lovaza, Aspirin|First both 81mg of Aspirin and 4 grams of Lovaza, then Placebo, then 4 grams of Lovaza, then 81mg of Aspirin
1018129|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018130|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018131|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018132|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018133|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018134|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018135|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018136|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018137|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018138|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018139|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018747|NCT00771914|E3|Reported Event|Lovaza, Both Aspirin and Lovaza, Placebo, Aspirin|First 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then Placebo, then 81mg of Aspirin
1018748|NCT00771914|E2|Reported Event|Aspirin, Lovaza, Both Aspirin and Lovaza, Placebo|First 81mg of Aspirin, then 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo
1019028|NCT00771667|O1|Outcome|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
1018140|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018141|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018142|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018143|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018144|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018145|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018146|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018147|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018148|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018149|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018150|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018749|NCT00771914|E1|Reported Event|Placebo, Lovaza, Aspirin, Both Aspirin and Lovaza|First Placebo, then 4 grams of Lovaza, then 81 mg of aspirin, then both 81mg of Aspirin and 4 grams of Lovaza
1018750|NCT00771875|B4|Baseline|Total|Total of all reporting groups
1018751|NCT00771875|B3|Baseline|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
1018151|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018152|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018153|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018154|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018155|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018156|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018157|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018158|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018159|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018160|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018161|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018752|NCT00771875|B2|Baseline|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
1019029|NCT00771667|O4|Outcome|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
1019030|NCT00771667|O3|Outcome|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
1018162|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018163|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018164|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018165|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018166|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018167|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018168|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018169|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018170|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018171|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018172|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018769|NCT00771875|O3|Outcome|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
1018770|NCT00771875|O2|Outcome|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
1018173|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018174|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018175|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018176|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018177|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018178|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018179|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018180|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018181|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018182|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018183|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018802|NCT00771810|O3|Outcome|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
1018803|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
1018804|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
1019931|NCT00769314|B3|Baseline|Total|Total of all reporting groups
1018184|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018185|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018186|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018187|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018188|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018189|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018190|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018191|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018192|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018193|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018194|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018805|NCT00771810|O3|Outcome|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
1018806|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
1018807|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
1020195|NCT00768599|P1|Participant Flow|Reference Drug|Econazole Nitrate Cream 1%
1018195|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018196|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018197|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018198|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018199|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018200|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018201|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018202|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018203|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018204|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018205|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018808|NCT00771810|O3|Outcome|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
1018809|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
1018810|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
1020196|NCT00768599|O3|Outcome|Control|Vehicle Foam
1018206|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018207|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018208|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018209|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018210|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018211|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018212|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018213|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018214|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018215|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018216|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018811|NCT00771810|O3|Outcome|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
1018812|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
1018813|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
1020197|NCT00768599|O2|Outcome|Test Drug|Econazole Nitrate Foam 1%
1018217|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018218|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018219|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018220|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018221|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018222|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018223|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018224|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018225|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018226|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018227|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018814|NCT00771810|O3|Outcome|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
1018815|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
1018816|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
1020198|NCT00768599|O1|Outcome|Reference Drug|Econazole Nitrate Cream 1%
1018228|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018229|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018230|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018231|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018232|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018233|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018234|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018235|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018236|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018237|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018238|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018817|NCT00771810|O3|Outcome|TXA127 300ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
1018818|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
1018819|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
1020199|NCT00768599|O3|Outcome|Control|Vehicle Foam
1018239|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018240|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018241|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018242|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018243|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018244|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018245|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018246|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018247|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018248|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018249|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018820|NCT00771810|O3|Outcome|TXA127 300ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
1018821|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
1018822|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
1020200|NCT00768599|O2|Outcome|Test Drug|Econazole Nitrate Foam 1%
1018250|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018251|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018252|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018253|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018254|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018255|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018256|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018257|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018258|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018259|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018260|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018823|NCT00771810|O3|Outcome|TXA127 300ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
1018824|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
1018825|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
1020201|NCT00768599|O1|Outcome|Reference Drug|Econazole Nitrate Cream 1%
1018261|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018262|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018263|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018264|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018265|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018266|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018267|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018268|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018269|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018270|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018271|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018826|NCT00771810|O3|Outcome|TXA127 300ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
1018827|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
1018828|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
1020202|NCT00768599|O3|Outcome|Control|Vehicle Foam
1018272|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018273|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018274|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018275|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018276|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018277|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018278|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018279|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018280|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018281|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018282|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018829|NCT00771810|E3|Reported Event|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
1018830|NCT00771810|E2|Reported Event|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
1018831|NCT00771810|E1|Reported Event|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
1018832|NCT00771758|B4|Baseline|Total|Total of all reporting groups
1018283|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018284|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018285|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018286|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018287|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018288|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018289|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018290|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018291|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018292|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018293|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018833|NCT00771758|B3|Baseline|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018834|NCT00771758|B2|Baseline|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018835|NCT00771758|B1|Baseline|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018836|NCT00771758|P3|Participant Flow|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018294|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018295|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018296|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018297|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018298|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018299|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018300|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018301|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018302|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018303|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018304|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018837|NCT00771758|P2|Participant Flow|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018838|NCT00771758|P1|Participant Flow|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018839|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018840|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018305|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018306|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018307|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018308|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018309|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018310|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018311|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018312|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018313|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018314|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018315|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018841|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018842|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018843|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018844|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018316|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018317|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018318|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018319|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018320|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018321|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018322|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018323|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018324|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018325|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018326|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018845|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018846|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018847|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018848|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1020203|NCT00768599|O2|Outcome|Test Drug|Econazole Nitrate Foam 1%
1018327|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018328|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018329|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018330|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018331|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018332|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018333|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018334|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018335|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018336|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018337|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018849|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018850|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018851|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018852|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018338|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018339|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018340|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018341|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018342|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018343|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018344|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018345|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018346|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018347|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018348|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018853|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018854|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018855|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018856|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018349|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018350|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018351|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018352|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018353|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018354|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018355|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018356|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018357|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018358|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018359|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018857|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018858|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018859|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018860|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1020204|NCT00768599|O1|Outcome|Reference Drug|Econazole Nitrate Cream 1%
1018360|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018361|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018362|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018363|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018364|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018365|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018366|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018367|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018368|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018369|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018370|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018861|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018862|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018863|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018864|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018371|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018372|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018373|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018374|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018375|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018376|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018377|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018378|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018379|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018380|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018381|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018865|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018866|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018867|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018868|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018382|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018383|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018384|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018385|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018386|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018387|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018388|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018389|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018390|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018391|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018392|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018869|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018870|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018871|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018872|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1020205|NCT00768599|O3|Outcome|Control|Vehicle Foam
1018393|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018394|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018395|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018396|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018397|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018398|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018399|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018400|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018401|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018402|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018403|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018873|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018874|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018875|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018876|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018404|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018405|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018406|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018407|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018408|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018409|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018410|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018411|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018412|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018413|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018414|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018877|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018878|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018879|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018880|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018415|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018416|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018417|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018418|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018419|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018420|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018421|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018422|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018423|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018424|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018425|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018881|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018882|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018883|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018884|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1020206|NCT00768599|O2|Outcome|Test Drug|Econazole Nitrate Foam 1%
1018426|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018427|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018428|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018429|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018430|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018431|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018432|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018433|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018434|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018435|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018436|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018885|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018886|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018887|NCT00771758|O5|Outcome|Baseline Total|Placebo
1018888|NCT00771758|O4|Outcome|Poor - End of Study|Placebo
1018889|NCT00771758|O3|Outcome|Fair - End of Study|Placebo
1018890|NCT00771758|O2|Outcome|Good - End of Study|Placebo
1018437|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018438|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018439|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018440|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018441|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018442|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018443|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018444|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018445|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018446|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018447|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018891|NCT00771758|O1|Outcome|Excellent - End of Study|Placebo
1018892|NCT00771758|O6|Outcome|Baseline Total|Oxycodone IR
1018893|NCT00771758|O5|Outcome|Missing - End of Study|Oxycodone IR
1018894|NCT00771758|O4|Outcome|Poor - End of Study|Oxycodone IR
1018895|NCT00771758|O3|Outcome|Fair - End of Study|Oxycodone IR
1018896|NCT00771758|O2|Outcome|Good - End of Study|Oxycodone IR
1018897|NCT00771758|O1|Outcome|Excellent - End of Study|Oxycodone IR
1018448|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018449|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018450|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018451|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018452|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018453|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018454|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018455|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018456|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018457|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018458|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018898|NCT00771758|O6|Outcome|Baseline Total|Tapentadol IR
1018899|NCT00771758|O5|Outcome|Missing - End of Study|Tapentadol IR
1018900|NCT00771758|O4|Outcome|Poor - End of Study|Tapentadol IR
1018901|NCT00771758|O3|Outcome|Fair - End of Study|Tapentadol IR
1018902|NCT00771758|O2|Outcome|Good - End of Study|Tapentadol IR
1018903|NCT00771758|O1|Outcome|Excellent - End of Study|Tapentadol IR
1020207|NCT00768599|O1|Outcome|Reference Drug|Econazole Nitrate Cream 1%
1018459|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018460|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018461|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018462|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018463|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018464|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018465|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018466|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018467|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018468|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018469|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018904|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018905|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018906|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018907|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1020208|NCT00768599|O3|Outcome|Control|Vehicle Foam
1018470|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018471|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018472|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018473|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018474|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018475|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018476|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018477|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018478|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018479|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018480|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018908|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018909|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018910|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018911|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018481|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018482|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018483|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018484|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018485|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018486|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018487|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018488|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018489|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018490|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018491|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018912|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018913|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018914|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018915|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018492|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018493|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018494|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018495|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018496|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018497|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018498|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018499|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018500|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018501|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018502|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018916|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018917|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018918|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018919|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1020209|NCT00768599|O2|Outcome|Test Drug|Econazole Nitrate Foam 1%
1018503|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018504|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018505|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018506|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018507|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018508|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018509|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018510|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018511|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018512|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018513|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018920|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018921|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018922|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018923|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018514|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018515|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018516|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018517|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018518|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018519|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018520|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018521|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018522|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018523|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018524|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018924|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018925|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018926|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018927|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018525|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018526|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018527|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018528|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018529|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018530|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018531|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018532|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018533|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018534|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018535|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018928|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018929|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018930|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018931|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1020210|NCT00768599|O1|Outcome|Reference Drug|Econazole Nitrate Cream 1%
1018536|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018537|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018538|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018539|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018540|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018541|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018542|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018543|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018544|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018545|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018546|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018932|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018933|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018934|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018935|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018547|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018548|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018549|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018550|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018551|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018552|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018553|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018554|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018555|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018556|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018557|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018936|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018937|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018938|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018939|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018558|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018559|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018560|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018561|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018562|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018563|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018564|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018565|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018566|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018567|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018568|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018940|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018941|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018942|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018943|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1020211|NCT00768599|O3|Outcome|Control|Vehicle Foam
1018569|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018570|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018571|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018572|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018573|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018574|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018575|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018576|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018577|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018578|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018579|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018944|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018945|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018946|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018947|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018580|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018581|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018582|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018583|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018584|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018585|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018586|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018587|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018588|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018589|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018590|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018948|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018949|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018950|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018951|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018591|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018592|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018593|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018594|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018595|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018596|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018597|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018598|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018599|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018600|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018601|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018952|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018953|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018954|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018955|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1020212|NCT00768599|O2|Outcome|Test Drug|Econazole Nitrate Foam 1%
1018602|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018603|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018604|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018605|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018606|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018607|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018608|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018609|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018610|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018611|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018612|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018956|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018957|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018958|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018959|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018613|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018614|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018615|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018616|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018617|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018618|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018619|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018620|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018621|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018622|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018623|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018960|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018961|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018962|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018963|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018624|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018625|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018626|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018627|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018628|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018629|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018630|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018631|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018632|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018633|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018634|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018964|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018965|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018966|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018967|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1020213|NCT00768599|O1|Outcome|Reference Drug|Econazole Nitrate Cream 1%
1018635|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018636|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018637|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018638|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018639|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018640|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018641|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018642|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018643|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018644|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018645|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018968|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018969|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018970|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018971|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018646|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018647|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018648|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018649|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018650|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018651|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018652|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018653|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018654|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018655|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018656|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018972|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018973|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018974|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018975|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018657|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018658|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018659|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018660|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018661|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018662|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018663|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018664|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018665|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018666|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018667|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018976|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018977|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018978|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018979|NCT00771758|O3|Outcome|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1020214|NCT00768599|E3|Reported Event|Control|Vehicle Foam
1018668|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018669|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018670|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018671|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018672|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018673|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018674|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018675|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018676|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018677|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018678|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018980|NCT00771758|O2|Outcome|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018981|NCT00771758|O1|Outcome|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018982|NCT00771758|E3|Reported Event|Placebo|1 capsule every 4 - 6 hr as needed for up to 10 days
1018983|NCT00771758|E2|Reported Event|Oxycodone IR|5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1018679|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018680|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018681|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018682|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018683|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018684|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018685|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018686|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018687|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018688|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018689|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018984|NCT00771758|E1|Reported Event|Tapentadol IR|50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
1018985|NCT00771745|B3|Baseline|Total|Total of all reporting groups
1019031|NCT00771667|O2|Outcome|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
1019032|NCT00771667|O1|Outcome|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
1020215|NCT00768599|E2|Reported Event|Test Drug|Econazole Nitrate Foam 1%
1018690|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018691|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018692|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018693|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018694|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018695|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018696|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018697|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018698|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018699|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018700|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018986|NCT00771745|B2|Baseline|Preloading Induction With Thymoglobulin® X 3 Doses|"Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF~anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF"
1019402|NCT00770991|O1|Outcome|Normal Mucosa|all participants combined for this analysis. Sample of normal mucosa
1018701|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018702|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018703|NCT00772005|O4|Outcome|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018704|NCT00772005|O3|Outcome|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018705|NCT00772005|O2|Outcome|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018706|NCT00772005|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018707|NCT00772005|E4|Reported Event|Matching Placebo|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018708|NCT00772005|E3|Reported Event|250 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018709|NCT00772005|E2|Reported Event|200 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018710|NCT00772005|E1|Reported Event|150 mg/Day Armodafinil|At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.
1018711|NCT00771953|B3|Baseline|Total|Total of all reporting groups
1018712|NCT00771953|B2|Baseline|Placebo Plus Docetaxel or Pemetrexed|Placebo and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
1018713|NCT00771953|B1|Baseline|Apricoxib Plus Docetaxel or Pemetrexed|Apricoxib 400mg qd and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
1018714|NCT00771953|P2|Participant Flow|Placebo Plus Docetaxel or Pemetrexed|Placebo and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
1018715|NCT00771953|P1|Participant Flow|Apricoxib Plus Docetaxel or Pemetrexed|Apricoxib 400mg qd and either docetaxel 75mg/m2 or pemetrexed 500mg/m2 q21 days
1018716|NCT00771953|O4|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed 500mg/m2 q21 days
1018717|NCT00771953|O3|Outcome|Apricoxib Plus Pemetrexed|Apricoxib 400mg qd plus pemetrexed 500mg/m2 q21 days
1018718|NCT00771953|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel 75mg/m2 q21 days
1019403|NCT00770991|O3|Outcome|All Participants|
1018753|NCT00771875|B1|Baseline|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
1018754|NCT00771875|P3|Participant Flow|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
1018755|NCT00771875|P2|Participant Flow|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
1018756|NCT00771875|P1|Participant Flow|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on cluster of differentiation 3 (CD3) count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via intravenous push (IVP) over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
1018757|NCT00771875|O3|Outcome|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
1018758|NCT00771875|O2|Outcome|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
1018759|NCT00771875|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
1018760|NCT00771875|O3|Outcome|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
1018761|NCT00771875|O2|Outcome|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
1018762|NCT00771875|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
1018763|NCT00771875|O3|Outcome|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
1018764|NCT00771875|O2|Outcome|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
1018765|NCT00771875|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
1018766|NCT00771875|O3|Outcome|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
1018767|NCT00771875|O2|Outcome|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
1018768|NCT00771875|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
1019024|NCT00771667|O1|Outcome|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
1019025|NCT00771667|O4|Outcome|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
1018771|NCT00771875|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
1018772|NCT00771875|O3|Outcome|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
1018773|NCT00771875|O2|Outcome|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
1018774|NCT00771875|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
1018775|NCT00771875|O3|Outcome|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
1018776|NCT00771875|O2|Outcome|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
1018777|NCT00771875|O1|Outcome|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
1018778|NCT00771875|E3|Reported Event|RATG/Bortezomib|"Rabbit Antithymocyte Globulin (RATG) + Bortezomib~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
1018779|NCT00771875|E2|Reported Event|RATG/Rituximab|"Rabbit Antithymocyte Globulin (RATG) + Rituximab~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care."
1018780|NCT00771875|E1|Reported Event|Rabbit Antithymocyte Globulin (RATG)|"RATG~Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.~Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.~Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10."
1018781|NCT00771849|B3|Baseline|Total|Total of all reporting groups
1018782|NCT00771849|B2|Baseline|Hiberix® Vaccine Group|Participants received Hiberix® Vaccine
1018783|NCT00771849|B1|Baseline|Menactra® Vaccine Group|Participants received Menactra® Vaccine
1018784|NCT00771849|P2|Participant Flow|Hiberix® Vaccine Group|Participants received Hiberix® Vaccine
1018785|NCT00771849|P1|Participant Flow|Menactra® Vaccine Group|Participants received Menactra® Vaccine
1018786|NCT00771849|O2|Outcome|Hiberix® Vaccine Group|Participants received Hiberix® Vaccine
1018787|NCT00771849|O1|Outcome|Menactra® Vaccine Group|Participants received Menactra® Vaccine
1018788|NCT00771849|O2|Outcome|Hiberix® Vaccine Group|Participants received Hiberix® Vaccine
1018789|NCT00771849|O1|Outcome|Menactra® Vaccine Group|Participants received Menactra® Vaccine
1018790|NCT00771849|E2|Reported Event|Hiberix® Vaccine Group|Participants received Hiberix® Vaccine
1018791|NCT00771849|E1|Reported Event|Menactra® Vaccine Group|Participants received Menactra® Vaccine
1018792|NCT00771810|B4|Baseline|Total|Total of all reporting groups
1018793|NCT00771810|B3|Baseline|TXA127 300ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
1018794|NCT00771810|B2|Baseline|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
1018795|NCT00771810|B1|Baseline|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
1018796|NCT00771810|P3|Participant Flow|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
1018797|NCT00771810|P2|Participant Flow|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
1018798|NCT00771810|P1|Participant Flow|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
1018799|NCT00771810|O3|Outcome|TXA127 300 ug/kg|Group 3: combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
1018800|NCT00771810|O2|Outcome|TXA127 100 ug/kg|Group 2: combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
1018801|NCT00771810|O1|Outcome|Placebo|Group 1: combination gemcitabine and platinum-based chemotherapy with concurrent placebo
1019457|NCT00770809|B4|Baseline|Total|Total of all reporting groups
1018987|NCT00771745|B1|Baseline|Preloading Induction With Thymoglobulin|"Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF~anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF"
1018988|NCT00771745|P2|Participant Flow|Preloading Induction With Thymoglobulin® X 3 Doses|"Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF~anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF"
1018989|NCT00771745|P1|Participant Flow|Preloading Induction With Thymoglobulin|"Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF~anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF"
1018990|NCT00771745|O2|Outcome|Preloading Induction With Thymoglobulin® X 3 Doses|"Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF~anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF"
1018991|NCT00771745|O1|Outcome|Preloading Induction With Thymoglobulin x 4 Doses|"Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF~anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF"
1018992|NCT00771745|E2|Reported Event|Preloading Induction With Thymoglobulin® X 3 Doses|"Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF~anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF"
1018993|NCT00771745|E1|Reported Event|Preloading Induction With Thymoglobulin|"Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF~anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF"
1018994|NCT00771667|B5|Baseline|Total|Total of all reporting groups
1018995|NCT00771667|B4|Baseline|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
1018996|NCT00771667|B3|Baseline|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
1018997|NCT00771667|B2|Baseline|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
1018998|NCT00771667|B1|Baseline|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
1018999|NCT00771667|P10|Participant Flow|Ustekinumab IV -> Nonresponder -> Ustekinumab 90mg SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Nonresponder at week 6 -> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16
1019000|NCT00771667|P9|Participant Flow|Ustekinumab IV -> Nonresponder -> Placebo SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Nonresponder at week 6 -> Receiving Placebo SC at Week 8 and Week 16
1019001|NCT00771667|P8|Participant Flow|Ustekinumab IV -> Responder -> Ustekinumab 90mg SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Responder at week 6 -> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16
1019002|NCT00771667|P7|Participant Flow|Ustekinumab IV -> Responder -> Placebo SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Responder at week 6 -> Receiving Placebo SC at Week 8 and Week 16
1019003|NCT00771667|P6|Participant Flow|Placebo IV -> Nonresponder -> Ustekinumab 270/90 mg SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -> Nonresponder at week 6 -> Receiving Ustekinumab 270 mg SC at Week 8 and 90 mg at Week 16
1019004|NCT00771667|P5|Participant Flow|Placebo IV -> Responder -> Placebo SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -> Responder at week 6 -> Receiving Placebo SC at Week 8 and Week 16
1019005|NCT00771667|P4|Participant Flow|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
1019006|NCT00771667|P3|Participant Flow|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
1019007|NCT00771667|P2|Participant Flow|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
1019008|NCT00771667|P1|Participant Flow|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
1019009|NCT00771667|O2|Outcome|Ustekinumab 90 mg SC|As a single subcutaneous dose at Weeks 8 and 16
1019010|NCT00771667|O1|Outcome|Placebo SC|As a single subcutaneous dose at Weeks 8 and 16
1019011|NCT00771667|O2|Outcome|Ustekinumab 90 mg SC|As a single subcutaneous dose at Weeks 8 and 16
1019012|NCT00771667|O1|Outcome|Placebo SC|As a single subcutaneous dose at Weeks 8 and 16
1019013|NCT00771667|O4|Outcome|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
1019014|NCT00771667|O3|Outcome|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
1019015|NCT00771667|O2|Outcome|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
1019016|NCT00771667|O1|Outcome|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
1019017|NCT00771667|O4|Outcome|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
1019018|NCT00771667|O3|Outcome|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
1019019|NCT00771667|O2|Outcome|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
1019020|NCT00771667|O1|Outcome|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
1019021|NCT00771667|O4|Outcome|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
1019022|NCT00771667|O3|Outcome|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
1019023|NCT00771667|O2|Outcome|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
1019033|NCT00771667|E10|Reported Event|Ustekinumab IV -> Nonresponder -> Ustekinumab 90mg SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Nonresponder at week 6 -> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16
1019034|NCT00771667|E9|Reported Event|Ustekinumab IV -> Nonresponder -> Placebo SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Nonresponder at week 6 -> Receiving Placebo SC at Week 8 and Week 16
1019035|NCT00771667|E8|Reported Event|Ustekinumab IV -> Responder -> Ustekinumab 90mg SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Responder at week 6 -> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16
1019036|NCT00771667|E7|Reported Event|Ustekinumab IV -> Responder -> Placebo SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Responder at week 6 -> Receiving Placebo SC at Week 8 and Week 16
1019037|NCT00771667|E6|Reported Event|Placebo IV -> Nonresponder -> Ustekinumab 270/90 mg SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -> Nonresponder at week 6 -> Receiving Ustekinumab 270 mg SC at Week 8 and 90 mg at Week 16
1019038|NCT00771667|E5|Reported Event|Placebo IV -> Responder -> Placebo SC (MP)|Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -> Responder at week 6 -> Receiving Placebo SC at Week 8 and Week 16
1019039|NCT00771667|E4|Reported Event|Ustekinumab 6 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
1019040|NCT00771667|E3|Reported Event|Ustekinumab 3 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
1019041|NCT00771667|E2|Reported Event|Ustekinumab 1 mg/kg (IP)|Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
1019042|NCT00771667|E1|Reported Event|Placebo (IP)|Induction phase (Week 0-8) (IP) - Placebo IV group
1019043|NCT00771615|B10|Baseline|Total|Total of all reporting groups
1019044|NCT00771615|B9|Baseline|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019045|NCT00771615|B8|Baseline|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019046|NCT00771615|B7|Baseline|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019047|NCT00771615|B6|Baseline|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019048|NCT00771615|B5|Baseline|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019049|NCT00771615|B4|Baseline|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019050|NCT00771615|B3|Baseline|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019051|NCT00771615|B2|Baseline|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019052|NCT00771615|B1|Baseline|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019053|NCT00771615|P9|Participant Flow|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019054|NCT00771615|P8|Participant Flow|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019055|NCT00771615|P7|Participant Flow|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019056|NCT00771615|P6|Participant Flow|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019057|NCT00771615|P5|Participant Flow|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019058|NCT00771615|P4|Participant Flow|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019059|NCT00771615|P3|Participant Flow|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019060|NCT00771615|P2|Participant Flow|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019061|NCT00771615|P1|Participant Flow|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019062|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019063|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019064|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019065|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019066|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019067|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019068|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019069|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019070|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019071|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019072|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019073|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019074|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019369|NCT00771238|B2|Baseline|Standard Care Arm|ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care.
1019075|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019076|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019077|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019078|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019079|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019080|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019081|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019082|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019083|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019084|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019085|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019086|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019087|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019088|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019089|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019090|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019091|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019092|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019370|NCT00771238|B1|Baseline|P500 Mattress|"ICU patients placed on a TC500 bed with standard pressure ulcer prevention care~Total Care P500 Mattress: Study mattress"
1024992|NCT00758459|O1|Outcome|AZD1236|AZD1236
1019093|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019094|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019095|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019096|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019097|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019098|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019099|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019100|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019101|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019102|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019103|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019104|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019105|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019106|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019107|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019108|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019246|NCT00771615|E5|Reported Event|A/Turkey H5N1 Influenza Formulation C2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1020216|NCT00768599|E1|Reported Event|Reference Drug|Econazole Nitrate Cream 1%
1019109|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019110|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019111|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019112|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019113|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019114|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019115|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019116|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019117|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019118|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019119|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019280|NCT00771537|B1|Baseline|HIV TEST MSG Control/ VACCINE TRIAL MSG Control|No message intervention control condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
1020217|NCT00768560|B7|Baseline|Total|Total of all reporting groups
1019120|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019121|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019122|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019123|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019124|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019125|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019126|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019127|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019128|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019129|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019130|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019281|NCT00771537|P16|Participant Flow|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Major|2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
1019131|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019132|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019133|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019134|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019135|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019136|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019137|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019138|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019139|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019140|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019141|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019142|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019143|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019144|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019145|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019146|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019147|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019148|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019149|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019150|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019151|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019152|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019153|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019282|NCT00771537|P15|Participant Flow|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Trivial|2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
1019154|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019155|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019156|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019157|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019158|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019159|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019160|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019161|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019162|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019163|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019164|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019283|NCT00771537|P14|Participant Flow|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 1-Sided|2-Sided major message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
1024993|NCT00758459|O2|Outcome|Placebo|Placebo
1019165|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019166|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019167|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019168|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019169|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019170|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019171|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019172|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019173|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019174|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019175|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019284|NCT00771537|P13|Participant Flow|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG Control|2-Sided major message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
1024994|NCT00758459|O1|Outcome|AZD1236|AZD1236
1019176|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019177|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019178|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019179|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019180|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019181|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019182|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019183|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019184|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019185|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019186|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019187|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019188|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019189|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019190|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019191|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019192|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019193|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019194|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019195|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019196|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019197|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019198|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019285|NCT00771537|P12|Participant Flow|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Major|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
1019199|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019200|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019201|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019202|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019203|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019204|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019205|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019206|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019207|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019208|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019209|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019286|NCT00771537|P11|Participant Flow|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Trivia|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
1019210|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019211|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019212|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019213|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019214|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019215|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019216|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019217|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019218|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019219|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019220|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019287|NCT00771537|P10|Participant Flow|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 1-Sided|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
1024995|NCT00758459|O2|Outcome|Placebo|Placebo
1019221|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019222|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019223|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019224|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019225|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019226|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019227|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019228|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019229|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019230|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019231|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019232|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019233|NCT00771615|O9|Outcome|A/Turkey H5N1 Influenza D2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019234|NCT00771615|O8|Outcome|A/Turkey H5N1 Influenza B2 + C2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019235|NCT00771615|O7|Outcome|A/Turkey H5N1 Influenza D1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019236|NCT00771615|O6|Outcome|A/Turkey H5N1 Influenza B1 + C1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019237|NCT00771615|O5|Outcome|A/Turkey H5N1 Influenza C2 + E2 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019238|NCT00771615|O4|Outcome|A/Turkey H5N1 Influenza B2 + D2 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019239|NCT00771615|O3|Outcome|A/Turkey H5N1 Influenza C1 + E1 Group|"Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019240|NCT00771615|O2|Outcome|A/Turkey H5N1 Influenza B1 + D1 Group|"Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine and subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine; data for both groups are pooled.~The different formulations of GSK A/turkey H5N1 Influenza vaccine were administered intramuscularly in the deltoid region of the non-dominant arm."
1019241|NCT00771615|O1|Outcome|A/Turkey H5N1 Influenza A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019242|NCT00771615|E9|Reported Event|A/Turkey H5N1 Influenza Formulation E2 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019243|NCT00771615|E8|Reported Event|A/Turkey H5N1 Influenza Formulation E1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019244|NCT00771615|E7|Reported Event|A/Turkey H5N1 Influenza Formulation D2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019245|NCT00771615|E6|Reported Event|A/Turkey H5N1 Influenza Formulation D1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019359|NCT00771264|B3|Baseline|Total|Total of all reporting groups
1019247|NCT00771615|E4|Reported Event|A/Turkey H5N1 Influenza Formulation C1 Group|Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019248|NCT00771615|E3|Reported Event|A/Turkey H5N1 Influenza Formulation B2 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019249|NCT00771615|E2|Reported Event|A/Turkey H5N1 Influenza Formulation B1 Group|Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019250|NCT00771615|E1|Reported Event|A/Turkey H5N1 Influenza Formulation A Group|Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1019251|NCT00771602|B4|Baseline|Total|Total of all reporting groups
1019252|NCT00771602|B3|Baseline|Rituximab + Alemtuzumab|Group 3: 375 mg/m^2 Rituximab + 30 mg SQ Alemtuzumab
1019253|NCT00771602|B2|Baseline|Alemtuzumab|Group 2: 30 mg subcutaneously (SQ) Alemtuzumab Alone
1019254|NCT00771602|B1|Baseline|Rituximab|Group 1: 375 mg/m^2 intravenous (IV) Rituximab Alone
1019255|NCT00771602|P3|Participant Flow|Rituximab + Alemtuzumab|Group 3: 375 mg/m^2 Rituximab + 30 mg SQ Alemtuzumab
1019256|NCT00771602|P2|Participant Flow|Alemtuzumab|Group 2: 30 mg subcutaneously (SQ) Alemtuzumab Alone
1019257|NCT00771602|P1|Participant Flow|Rituximab|Group 1: 375 mg/m^2 intravenous (IV) Rituximab Alone
1019258|NCT00771602|O3|Outcome|Rituximab + Alemtuzumab|Group 3: 375 mg/m^2 Rituximab + 30 mg SQ Alemtuzumab
1019259|NCT00771602|O2|Outcome|Alemtuzumab|Group 2: 30 mg subcutaneously (SQ) Alemtuzumab Alone
1019260|NCT00771602|O1|Outcome|Rituximab|Group 1: 375 mg/m^2 intravenous (IV) Rituximab Alone
1019261|NCT00771602|E3|Reported Event|Rituximab + Alemtuzumab|Group 3: 375 mg/m^2 Rituximab + 30 mg SQ Alemtuzumab
1019262|NCT00771602|E2|Reported Event|Alemtuzumab|Group 2: 30 mg subcutaneously (SQ) Alemtuzumab Alone
1019263|NCT00771602|E1|Reported Event|Rituximab|Group 1: 375 mg/m^2 intravenous (IV) Rituximab Alone
1019264|NCT00771537|B17|Baseline|Total|Total of all reporting groups
1019265|NCT00771537|B16|Baseline|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Major|2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
1019266|NCT00771537|B15|Baseline|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Trivial|2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
1019267|NCT00771537|B14|Baseline|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 1-Sided|2-Sided major message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
1019268|NCT00771537|B13|Baseline|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG Control|2-Sided major message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
1019269|NCT00771537|B12|Baseline|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Major|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
1019270|NCT00771537|B11|Baseline|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Trivia|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
1019271|NCT00771537|B10|Baseline|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 1-Sided|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
1019272|NCT00771537|B9|Baseline|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG Control|2-Sided Trivial message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
1019273|NCT00771537|B8|Baseline|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Major|1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Major message intervention experimental condition regarding HIV vaccine clinical trial participation.
1019274|NCT00771537|B7|Baseline|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Trivial|1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
1019275|NCT00771537|B6|Baseline|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 1-Sided|1-Sided message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
1019276|NCT00771537|B5|Baseline|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG Control|1-Sided message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
1019277|NCT00771537|B4|Baseline|HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Major|No message intervention control condition regarding HIV testing AND 2-Sided Major message experimental intervention condition regarding HIV vaccine clinical trial participation.
1019278|NCT00771537|B3|Baseline|HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Trivial|No message intervention control condition regarding HIV testing AND 2-Sided trivial message experimental intervention condition regarding HIV vaccine clinical trial participation.
1019279|NCT00771537|B2|Baseline|HIV TEST MSG Control/ VACCINE TRIAL MSG 1-Sided|No message intervention control condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
1019288|NCT00771537|P9|Participant Flow|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG Control|2-Sided Trivial message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
1019289|NCT00771537|P8|Participant Flow|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Major|1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
1019290|NCT00771537|P7|Participant Flow|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Trivial|1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
1019291|NCT00771537|P6|Participant Flow|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 1-Sided|1-Sided message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
1019292|NCT00771537|P5|Participant Flow|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG Control|1-Sided message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
1019293|NCT00771537|P4|Participant Flow|HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Major|No message intervention control condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
1019294|NCT00771537|P3|Participant Flow|HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Trivial|No message intervention control condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
1019295|NCT00771537|P2|Participant Flow|HIV TEST MSG Control/ VACCINE TRIAL MSG 1-Sided|No message intervention control condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
1019296|NCT00771537|P1|Participant Flow|HIV TEST MSG Control/ VACCINE TRIAL MSG Control|No message intervention control condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
1019297|NCT00771537|O4|Outcome|2-Sided Major|No message intervention control condition regarding HIV testing AND 2-Sided Major message experimental intervention condition regarding HIV vaccine clinical trial participation.
1019298|NCT00771537|O3|Outcome|2-Sided Trivial|No message intervention control condition regarding HIV testing AND 2-Sided trivial message experimental intervention condition regarding HIV vaccine clinical trial participation.
1019299|NCT00771537|O2|Outcome|1-Sided|No message intervention control condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
1019300|NCT00771537|O1|Outcome|Control/Control|No message intervention control condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
1019301|NCT00771537|O4|Outcome|2-Sided Major|2-Sided major message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
1019302|NCT00771537|O3|Outcome|2-Sided Trivial|2-Sided Trivial message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
1019303|NCT00771537|O2|Outcome|1-Sided|1-Sided message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
1019304|NCT00771537|O1|Outcome|Control|No message intervention control condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
1019305|NCT00771537|E16|Reported Event|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Major|2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
1019306|NCT00771537|E15|Reported Event|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Trivial|2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
1019307|NCT00771537|E14|Reported Event|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 1-Sided|2-Sided major message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
1019308|NCT00771537|E13|Reported Event|HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG Control|2-Sided major message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
1019309|NCT00771537|E12|Reported Event|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Major|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
1019310|NCT00771537|E11|Reported Event|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Trivia|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
1019311|NCT00771537|E10|Reported Event|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 1-Sided|2-Sided Trivial message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
1019312|NCT00771537|E9|Reported Event|HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG Control|2-Sided Trivial message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
1019313|NCT00771537|E8|Reported Event|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Major|1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Major message intervention experimental condition regarding HIV vaccine clinical trial participation.
1019314|NCT00771537|E7|Reported Event|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Trivial|1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
1019360|NCT00771264|B2|Baseline|Sham / Placebo|
1019361|NCT00771264|B1|Baseline|Urgent PC|
1019362|NCT00771264|P2|Participant Flow|Sham / Placebo|
1019315|NCT00771537|E6|Reported Event|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 1-Sided|1-Sided message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
1019316|NCT00771537|E5|Reported Event|HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG Control|1-Sided message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
1019317|NCT00771537|E4|Reported Event|HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Major|No message intervention control condition regarding HIV testing AND 2-Sided Major message experimental intervention condition regarding HIV vaccine clinical trial participation.
1019318|NCT00771537|E3|Reported Event|HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Trivial|No message intervention control condition regarding HIV testing AND 2-Sided trivial message experimental intervention condition regarding HIV vaccine clinical trial participation.
1019319|NCT00771537|E2|Reported Event|HIV TEST MSG Control/ VACCINE TRIAL MSG 1-Sided|No message intervention control condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
1019320|NCT00771537|E1|Reported Event|HIV TEST MSG Control/ VACCINE TRIAL MSG Control|No message intervention control condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
1019321|NCT00771472|B1|Baseline|Vorinostat|Parts I & II: vorinostat (400 mg) oral, daily (QD). Treatment period was 28 days per cycle.
1019322|NCT00771472|P2|Participant Flow|Part II|Vorinostat 400 mg oral, daily (QD). Treatment period was 28 days per cycle.
1019323|NCT00771472|P1|Participant Flow|Part I|Vorinostat 400 mg oral, daily (QD). Treatment period was 28 days per cycle.
1019324|NCT00771472|O1|Outcome|Vorinostat|Part I: vorinostat (400 mg) oral, daily (QD). Treatment period was 28 days per cycle.
1019325|NCT00771472|O1|Outcome|Vorinostat|Part I: vorinostat (400 mg) oral, daily (QD). Treatment period was 28 days per cycle.
1019326|NCT00771472|O1|Outcome|Vorinostat|Part I: vorinostat (400 mg) oral, daily (QD). Treatment period was 28 days per cycle.
1019327|NCT00771472|O1|Outcome|Vorinostat|Part I: vorinostat (400 mg) oral, daily (QD). Treatment period was 28 days per cycle.
1019328|NCT00771472|O1|Outcome|Vorinostat|Part I: vorinostat (400 mg) oral, daily (QD). Treatment period was 28 days per cycle.
1019329|NCT00771472|O1|Outcome|Vorinostat|Parts I & II: vorinostat (400 mg) oral, daily (QD). Treatment period was 28 days per cycle.
1019330|NCT00771472|E1|Reported Event|Vorinostat|Parts I & II: vorinostat(400 mg) Oral, daily (QD). Treatment period was 28 days per cycle.
1019331|NCT00771407|B3|Baseline|Total|Total of all reporting groups
1019332|NCT00771407|B2|Baseline|Standard Ostomy Construction|Ostomy created in the standard fashion
1019333|NCT00771407|B1|Baseline|Strattice Fascial Inlay|Strattice placed as a fascial inlay to support the ostomy site
1019334|NCT00771407|P2|Participant Flow|Standard Ostomy Construction|Ostomy created in the standard fashion
1019335|NCT00771407|P1|Participant Flow|Strattice Fascial Inlay|Strattice placed as a fascial inlay to support the ostomy site
1019336|NCT00771407|O2|Outcome|Standard Ostomy Construction|Ostomy will be created in the standard fashion
1019337|NCT00771407|O1|Outcome|Strattice Fascial Inlay|Strattice will be placed as a fascial inlay to support the ostomy site
1019338|NCT00771407|E2|Reported Event|Standard Ostomy Construction|Ostomy created in the standard fashion
1019339|NCT00771407|E1|Reported Event|Strattice Fascial Inlay|Strattice placed as a fascial inlay to support the ostomy site
1019340|NCT00771316|B3|Baseline|Total|Total of all reporting groups
1019341|NCT00771316|B2|Baseline|Meropenem|Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.
1019342|NCT00771316|B1|Baseline|MK0826 (Ertapenem)|MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
1019343|NCT00771316|P2|Participant Flow|Meropenem|Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.
1019344|NCT00771316|P1|Participant Flow|MK0826 (Ertapenem)|MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
1019345|NCT00771316|O2|Outcome|Meropenem|Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.
1019346|NCT00771316|O1|Outcome|MK0826 (Ertapenem)|MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
1019347|NCT00771316|O2|Outcome|Meropenem|Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.
1019348|NCT00771316|O1|Outcome|MK0826 (Ertapenem)|MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
1019349|NCT00771316|O2|Outcome|Meropenem|Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.
1019350|NCT00771316|O1|Outcome|MK0826 (Ertapenem)|MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
1019351|NCT00771316|E2|Reported Event|Meropenem|Meropenem-Patient received a once daily, intravenous infusion of 500 mg of meropenem at Hours 0, 8 and 16 for at least 4 days.
1019352|NCT00771316|E1|Reported Event|MK0826 (Ertapenem)|MK0826-Patient received a once daily, intravenous infusion of 1.0g of MK0826 plus placebo (0.9% saline) at Hours 0, 8 and 16 for at least 4 days.
1019353|NCT00771277|B1|Baseline|Arm 1|Family experience of concerns and providing support to TBI patient
1019354|NCT00771277|P1|Participant Flow|Arm 1|"Use of volunteer support teams to provide services~Support Teams: Use of volunteers organized into teams with a coordinator to provide services to TBI family"
1019355|NCT00771277|O1|Outcome|TBI Caregivers|Family caregivers providing support to TBI patients.
1019356|NCT00771277|O1|Outcome|TBI Caregivers|Family caregivers providing support to TBI patients.
1019357|NCT00771277|O1|Outcome|TBI Caregivers|Family caregivers providing support to TBI patients.
1019358|NCT00771277|E1|Reported Event|TBI Caregivers|Family caregivers providing support to TBI patients.
1019371|NCT00771238|P2|Participant Flow|Standard Care Arm|ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care.
1019372|NCT00771238|P1|Participant Flow|P500 Mattress|"ICU patients placed on a TC500 bed with standard pressure ulcer prevention care~Total Care P500 Mattress: Study mattress"
1019373|NCT00771238|O2|Outcome|Standard Care Arm|ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care.
1019374|NCT00771238|O1|Outcome|P500 Mattress|"ICU patients placed on a TC500 bed with standard pressure ulcer prevention care~Total Care P500 Mattress: Study mattress"
1019375|NCT00771238|O2|Outcome|Standard Care Arm|ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care.
1019376|NCT00771238|O1|Outcome|P500 Mattress|"ICU patients placed on a TC500 bed with standard pressure ulcer prevention care~Total Care P500 Mattress: Study mattress"
1019377|NCT00771238|E2|Reported Event|Standard Care Arm|ICU patients that receive standard of care mattress (Total Care Treatment Mattress) and standard pressure ulcer prevention care.
1019378|NCT00771238|E1|Reported Event|P500 Mattress|"ICU patients placed on a TC500 bed with standard pressure ulcer prevention care~Total Care P500 Mattress: Study mattress"
1019379|NCT00771173|B3|Baseline|Total|Total of all reporting groups
1019380|NCT00771173|B2|Baseline|Placebo Group|"For participants randomized to the placebo group will follow the same dosing schedule for the study medication, although they will receive an inert placebo tablet.~Placebo: Placebo tablet administered q8 hours for 24 hours postop."
1019381|NCT00771173|B1|Baseline|Active Agent Group|"Participants that are randomized to the phenazopyridine HCl group will receive the study medication (200 mg of phenzopyridine HCl orally) after leaving the operating room. We anticipate the first dose to be given after the patient has left the recovery area. We will continue use of study medication until it has been given up to 24 hours after the first VAS collection or catheter removal, whichever occurs first~phenazopyridine HCl: Phenazopyrdine HCl 200 mg q8h x 24"
1019382|NCT00771173|P2|Participant Flow|Active Agent Group|Participants that are randomized to the phenazopyridine HCl group will receive the study medication (200 mg of phenzopyridine HCl orally) after leaving the operating room. We anticipate the first dose to be given after the patient has left the recovery area. We will continue use of study medication until it has been given up to 24 hours after the first VAS collection or catheter removal, whichever occurs first
1019383|NCT00771173|P1|Participant Flow|Placebo Group|"For participants randomized to the placebo group will follow the same dosing schedule for the study medication, although they will receive an inert placebo tablet.~Blinding: The research pharmacist has facilitated the blinding by placing the active agent (200 mg tablets) into a solid colored capsule. She will make matching placebo capsules filled with lactose powder. To aid in blinding and avoid systemic administration of other dye agents for women in the placebo group, a small amount of orange dye will be placed in the Foley bag. This has been tested in the planning for this trial and is known effectively color the urine orange."
1019384|NCT00771173|O2|Outcome|Placebo Group|"For participants randomized to the placebo group will follow the same dosing schedule for the study medication, although they will receive an inert placebo tablet.~Placebo: Placebo tablet administered q8 hours for 24 hours postop."
1019385|NCT00771173|O1|Outcome|Active Agent Group|"Participants that are randomized to the phenazopyridine HCl group will receive the study medication (200 mg of phenzopyridine HCl orally) after leaving the operating room. We anticipate the first dose to be given after the patient has left the recovery area. We will continue use of study medication until it has been given up to 24 hours after the first VAS collection or catheter removal, whichever occurs first~phenazopyridine HCl: Phenazopyrdine HCl 200 mg q8h x 24"
1019386|NCT00771173|E2|Reported Event|Placebo Group|"For participants randomized to the placebo group will follow the same dosing schedule for the study medication, although they will receive an inert placebo tablet.~Placebo: Placebo tablet administered q8 hours for 24 hours postop."
1019387|NCT00771173|E1|Reported Event|Active Agent Group|"Participants that are randomized to the phenazopyridine HCl group will receive the study medication (200 mg of phenzopyridine HCl orally) after leaving the operating room. We anticipate the first dose to be given after the patient has left the recovery area. We will continue use of study medication until it has been given up to 24 hours after the first VAS collection or catheter removal, whichever occurs first~phenazopyridine HCl: Phenazopyrdine HCl 200 mg q8h x 24"
1019388|NCT00771056|B1|Baseline|Hydroxychloroquine|Hydroxychloroquine 400 mg po daily for up to one year.
1019389|NCT00771056|P1|Participant Flow|Hydroxychloroquine|Hydroxychloroquine 400 mg po daily for up to one year.
1019390|NCT00771056|O1|Outcome|Hydroxychloroquine|Hydroxychloroquine 400 mg po daily for up to one year.
1019391|NCT00771056|O1|Outcome|Hydroxychloroquine|Hydroxychloroquine 400 mg po daily for up to one year.
1019392|NCT00771056|E1|Reported Event|Hydroxychloroquine|"Hydroxychloroquine 400 mg po daily for up to one year.~Hydroxychloroquine: 400mg by mouth daily x 1 year"
1019393|NCT00770991|B3|Baseline|Total|Total of all reporting groups
1019394|NCT00770991|B2|Baseline|Two Berry Suppositories Bedtime Plus Placebo Powder|20 g of placebo powder administered as an oral slurry 3 times per day, plus 2 berry suppositories administered at bedtime. Each suppository contains 730 mg Black Raspberries
1019395|NCT00770991|B1|Baseline|Two Berry Suppositories Bedtime Plus Oral Berry Powder|20 g of lyophilized berry powder administered orally 3 times per day, plus 2 berry suppositories administered at bedtime. Each suppository contains 730 mg Black Raspberries
1019396|NCT00770991|P2|Participant Flow|Black Raspberry Slurry Plus 2 Berry Suppositories|20 grams of lyophilized berry powder administered as an oral slurry three times a day, plus 2 730 mg berry suppositories administered at bedtime. Each suppository contained 730 mg black raspberries.
1019397|NCT00770991|P1|Participant Flow|Placebo Powder Plus 2 Berry Suppositories|20 gram placebo powder administered as an oral slurry three times a day, plus 2 730 mg berry suppositories administered at bedtime. Each berry suppository contained 730 mg black raspberries.
1019398|NCT00770991|O3|Outcome|All Participants|
1019399|NCT00770991|O2|Outcome|Lyophilized BRB Suppositories + BRB Slurry|
1019400|NCT00770991|O1|Outcome|Lyophilized Black Raspberry (BRB) Suppositories + Placebo|Two, 730 mg BRB suppositories administered at bedtime.
1019401|NCT00770991|O2|Outcome|Polyp|all participants used for this analysis
1019404|NCT00770991|O2|Outcome|Lypholized BRB Suppositiry Plus BRB Slurry|2 lyphilized black raspberry suppositories plus black raspberry slurry.
1019405|NCT00770991|O1|Outcome|Lyophilized Black Raspberry (BRB) Suppositories Plus Placebo|Two, 730 mg BRB suppositories administered at bedtime plus 20 grams placebo slurry .
1019406|NCT00770991|E2|Reported Event|Black Raspberry Slurry Plus 2 Berry Suppositories|20 grams of lyophilized berry powder administered as an oral slurry three times a day, plus 2 730 mg berry suppositories administered at bedtime. Each suppository contained 730 mg black raspberries.
1019407|NCT00770991|E1|Reported Event|Black Raspberry Placebo Slurry Plus 2 Berry Suppositories|20 gram placebo powder administered as an oral slurry three times a day, plus 2 730 mg berry suppositories administered at bedtime. Each berry suppository contained 730 mg black raspberries.
1019408|NCT00770965|B5|Baseline|Total|Total of all reporting groups
1019409|NCT00770965|B4|Baseline|Placebo|Participants received placebo to AIN457A IV on day 1.
1019410|NCT00770965|B3|Baseline|AIN457 3.0 mg/kg|Participants received AIN457 3.0 mg/kg IV on Day 1.
1019411|NCT00770965|B2|Baseline|AIN457 1.0 mg/kg|Participants received AIN457 1.0 mg/kg IV on Day 1.
1019412|NCT00770965|B1|Baseline|AIN457 0.3 mg/kg|Participants received AIN457 0.3 mg/kg IV on Day 1.
1019413|NCT00770965|P4|Participant Flow|Placebo|Participants received placebo to AIN457A IV on day 1.
1019414|NCT00770965|P3|Participant Flow|AIN457 3.0 mg/kg|Participants received AIN457 3.0 mg/kg IV on Day 1.
1019415|NCT00770965|P2|Participant Flow|AIN457 1.0 mg/kg|Participants received AIN457 1.0 mg/kg IV on Day 1.
1019416|NCT00770965|P1|Participant Flow|AIN457 0.3 mg/kg|Participants received AIN457 0.3 mg/kg IV on Day 1.
1019417|NCT00770965|O4|Outcome|Placebo|Participants received placebo to AIN457A IV on day 1.
1019418|NCT00770965|O3|Outcome|AIN457 3.0 mg/kg|Participants received AIN457 3.0 mg/kg IV on Day 1.
1019419|NCT00770965|O2|Outcome|AIN457 1.0 mg/kg|Participants received AIN457 1.0 mg/kg IV on Day 1.
1019420|NCT00770965|O1|Outcome|AIN457 0.3 mg/kg|Participants received AIN457 0.3 mg/kg IV on Day 1.
1019421|NCT00770965|O4|Outcome|Placebo|Participants received placebo to AIN457A IV on day 1.
1019422|NCT00770965|O3|Outcome|AIN457 3.0 mg/kg|Participants received AIN457 3.0 mg/kg IV on Day 1.
1019423|NCT00770965|O2|Outcome|AIN457 1.0 mg/kg|Participants received AIN457 1.0 mg/kg IV on Day 1.
1019424|NCT00770965|O1|Outcome|AIN457 0.3 mg/kg|Participants received AIN457 0.3 mg/kg IV on Day 1.
1019425|NCT00770965|O4|Outcome|Placebo|Participants received placebo to AIN457A IV on day 1.
1019426|NCT00770965|O3|Outcome|AIN457 3.0 mg/kg|Participants received AIN457 3.0 mg/kg IV on Day 1.
1019427|NCT00770965|O2|Outcome|AIN457 1.0 mg/kg|Participants received AIN457 1.0 mg/kg IV on Day 1.
1019428|NCT00770965|O1|Outcome|AIN457 0.3 mg/kg|Participants received AIN457 0.3 mg/kg IV on Day 1.
1019429|NCT00770965|E4|Reported Event|Placebo|Placebo
1019430|NCT00770965|E3|Reported Event|AIN457 3 mg/kg|AIN457 3 mg/kg
1019431|NCT00770965|E2|Reported Event|AIN457 1 mg/kg|AIN457 1 mg/kg
1019432|NCT00770965|E1|Reported Event|AIN457 0.3 mg/kg|AIN457 0.3 mg/kg
1019433|NCT00770913|B4|Baseline|Total|Total of all reporting groups
1019434|NCT00770913|B3|Baseline|E3810 20 mg Twice Daily|E3810 20mg twice daily orally for 8 weeks
1019435|NCT00770913|B2|Baseline|E3810 10 mg Twice Daily|E3810 10mg twice daily orally for 8 weeks
1019436|NCT00770913|B1|Baseline|E3810 20 mg Once Daily|E3810 20mg once daily orally for 8 weeks
1019437|NCT00770913|P3|Participant Flow|E3810 20 mg Twice Daily|E3810 20mg twice daily orally for 8 weeks
1019438|NCT00770913|P2|Participant Flow|E3810 10 mg Twice Daily|E3810 10mg twice daily orally for 8 weeks
1019439|NCT00770913|P1|Participant Flow|E3810 20 mg Once Daily|E3810 20mg once daily orally for 8 weeks
1019440|NCT00770913|O3|Outcome|E3810 20 mg|E3810 20 mg twice daily orally for 8 weeks
1019441|NCT00770913|O2|Outcome|E3810 10 mg Twice Daily|E3810 10 mg twice daily orally for 8 weeks
1019442|NCT00770913|O1|Outcome|E3810 20 mg Once Daily|E3810 20 mg once daily orally for 8 weeks
1019443|NCT00770913|E3|Reported Event|E3810 20 mg|E3810 20 mg twice daily orally for 8 weeks
1019444|NCT00770913|E2|Reported Event|E3810 10 mg Twice Daily|E3810 10 mg twice daily orally for 8 weeks
1019445|NCT00770913|E1|Reported Event|E3810 20 mg Once Daily|E3810 20 mg once daily orally for 8 weeks
1019446|NCT00770861|B3|Baseline|Total|Total of all reporting groups
1019447|NCT00770861|B2|Baseline|Placebo|Matching placebo tablets, oral administration
1019448|NCT00770861|B1|Baseline|Nebivolol|Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration
1019449|NCT00770861|P2|Participant Flow|Placebo|Matching placebo tablets, oral administration
1019450|NCT00770861|P1|Participant Flow|Nebivolol|Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration
1019451|NCT00770861|O2|Outcome|Placebo|Matching placebo tablets, oral administration
1019452|NCT00770861|O1|Outcome|Nebivolol|Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration
1019453|NCT00770861|O2|Outcome|Placebo|Matching placebo tablets, oral administration
1019454|NCT00770861|O1|Outcome|Nebivolol|Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration
1019455|NCT00770861|E2|Reported Event|Placebo|Matching placebo tablets, oral administration
1019456|NCT00770861|E1|Reported Event|Nebivolol|Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration
1019458|NCT00770809|B3|Baseline|Arm III (TL)|Patients receive paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 15000 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. (Discontinued as of 6-15-11)
1019459|NCT00770809|B2|Baseline|Arm II (TH)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly for 16 weeks in the absence of disease progression or unacceptable toxicity.
1019460|NCT00770809|B1|Baseline|Arm I (THL)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 750 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity.
1019461|NCT00770809|P3|Participant Flow|Arm III (TL)|Patients receive paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 15000 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. (Discontinued as of 6-15-11)
1019462|NCT00770809|P2|Participant Flow|Arm II (TH)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly for 16 weeks in the absence of disease progression or unacceptable toxicity.
1019463|NCT00770809|P1|Participant Flow|Arm I (THL)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 750 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity.
1019464|NCT00770809|O3|Outcome|Arm III (TL)|Patients receive paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 15000 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. (Discontinued as of 6-15-11)
1019465|NCT00770809|O2|Outcome|Arm II (TH)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly for 16 weeks in the absence of disease progression or unacceptable toxicity.
1019466|NCT00770809|O1|Outcome|Arm I (THL)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 750 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity.
1019467|NCT00770809|E3|Reported Event|Arm III (TL)|Patients receive paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 15000 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. (Discontinued as of 6-15-11)
1019468|NCT00770809|E2|Reported Event|Arm II (TH)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly for 16 weeks in the absence of disease progression or unacceptable toxicity.
1019469|NCT00770809|E1|Reported Event|Arm I (THL)|Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 750 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity.
1019470|NCT00770770|B3|Baseline|Total|Total of all reporting groups
1019471|NCT00770770|B2|Baseline|Fluocinolone Acetonide 0.5 µg/Day|"0.5 µg/day~Fluocinolone Acetonide: 0.5 µg/day"
1019472|NCT00770770|B1|Baseline|Fluocinolone Acetonide 0.2 µg/Day|"0.2 µg/day~Fluocinolone Acetonide: 0.2 µg/day"
1019473|NCT00770770|P2|Participant Flow|Fluocinolone Acetonide: 0.5 µg/Day|Fluocinolone Acetonide: 0.5 µg/day
1019474|NCT00770770|P1|Participant Flow|Fluocinolone Acetonide: 0.2 µg/Day|Fluocinolone Acetonide: 0.2 µg/day
1019475|NCT00770770|O2|Outcome|Fluocinolone Acetonide 0.5 µg/Day|"0.5 µg/day~Fluocinolone Acetonide: 0.5 µg/day"
1019476|NCT00770770|O1|Outcome|Fluocinolone Acetonide 0.2 µg/Day|"0.2 µg/day~Fluocinolone Acetonide: 0.2 µg/day"
1019477|NCT00770770|E2|Reported Event|Fluocinolone Acetonide: 0.5 µg/Day|Fluocinolone Acetonide: 0.5 µg/day
1019478|NCT00770770|E1|Reported Event|Fluocinolone Acetonide: 0.2 µg/Day|Fluocinolone Acetonide: 0.2 µg/day
1019479|NCT00770757|B1|Baseline|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
1019480|NCT00770757|P1|Participant Flow|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
1019481|NCT00770757|O1|Outcome|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
1019482|NCT00770757|O1|Outcome|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
1019483|NCT00770757|O1|Outcome|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
1019484|NCT00770757|O1|Outcome|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
1019485|NCT00770757|O1|Outcome|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
1019486|NCT00770757|E1|Reported Event|CC-4047 Arm|CC-4047 2 mg orally every day for 1 course (12 weeks or 84 days). Every 28 days of treatment are considered as 1 cycle and every 3 cycles are are considered as 1 course of treatment. A total of 4 courses of treatment are planned (12 months).
1019487|NCT00770692|B5|Baseline|Total|Total of all reporting groups
1019488|NCT00770692|B4|Baseline|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
1019489|NCT00770692|B3|Baseline|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
1019490|NCT00770692|B2|Baseline|Eszopiclone 2 mg- Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
1019491|NCT00770692|B1|Baseline|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
1019492|NCT00770692|P4|Participant Flow|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
1019493|NCT00770692|P3|Participant Flow|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
1019494|NCT00770692|P2|Participant Flow|Eszopiclone 2 mg- Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
1019495|NCT00770692|P1|Participant Flow|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
1019496|NCT00770692|O4|Outcome|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
1019497|NCT00770692|O3|Outcome|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
1019498|NCT00770692|O2|Outcome|Eszopiclone 2 mg- Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
1019499|NCT00770692|O1|Outcome|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
1019500|NCT00770692|O4|Outcome|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
1019501|NCT00770692|O3|Outcome|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
1019502|NCT00770692|O2|Outcome|Eszopiclone 2 mg- Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
1019503|NCT00770692|O1|Outcome|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
1019504|NCT00770692|O4|Outcome|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
1019505|NCT00770692|O3|Outcome|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
1019506|NCT00770692|O2|Outcome|Eszopiclone 2 mg- Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
1019507|NCT00770692|O1|Outcome|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
1019508|NCT00770692|O4|Outcome|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
1019509|NCT00770692|O3|Outcome|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
1019510|NCT00770692|O2|Outcome|Eszopiclone 2 mg- Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
1019511|NCT00770692|O1|Outcome|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
1019634|NCT00770510|O5|Outcome|Zolpidem Tartrate 10 mg|Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019512|NCT00770692|O4|Outcome|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
1019513|NCT00770692|O3|Outcome|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
1019514|NCT00770692|O2|Outcome|Eszopiclone 2 mg- Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
1019515|NCT00770692|O1|Outcome|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
1019516|NCT00770692|E4|Reported Event|Eszopiclone 2 mg Elderly|"Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
1019517|NCT00770692|E3|Reported Event|Eszopiclone 1 mg- Elderly|"Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
1019518|NCT00770692|E2|Reported Event|Eszopiclone 3 mg- Non-elderly|"Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment."
1019519|NCT00770692|E1|Reported Event|Eszopiclone 2 mg- Non-elderly|"Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.~Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment."
1019520|NCT00770653|B3|Baseline|Total|Total of all reporting groups
1019521|NCT00770653|B2|Baseline|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019522|NCT00770653|B1|Baseline|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019523|NCT00770653|P2|Participant Flow|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019524|NCT00770653|P1|Participant Flow|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019525|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019526|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019527|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019528|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019529|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019530|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019531|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019532|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019533|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019534|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019535|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019536|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1020218|NCT00768560|B6|Baseline|Nifedipine 80 mg OD x 40 mg BID x 40 mg OD for 2 Weeks Each|
1019537|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019538|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019539|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019540|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019541|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019542|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019543|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019544|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019545|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019546|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019547|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019548|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019549|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019550|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019551|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019552|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019553|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019554|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019555|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019556|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019557|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019558|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019559|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019560|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019561|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019635|NCT00770510|O4|Outcome|Eszopiclone 3 mg|Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019562|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019563|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019564|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019565|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019566|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019567|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019568|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019569|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019570|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019571|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019572|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019573|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019574|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019575|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019576|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019577|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019578|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019579|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019580|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019581|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019582|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019583|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019584|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019585|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019586|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019636|NCT00770510|O3|Outcome|Eszopiclone 2 mg|Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019587|NCT00770653|O2|Outcome|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019588|NCT00770653|O1|Outcome|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019589|NCT00770653|E2|Reported Event|Glimepiride 2 mg and Metformin 850 mg BID|Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1019590|NCT00770653|E1|Reported Event|Pioglitazone 15 mg and Metformin 850 mg BID|Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.
1019591|NCT00770588|B3|Baseline|Total|Total of all reporting groups
1019592|NCT00770588|B2|Baseline|Placebo|placebo 1 tablet daily
1019593|NCT00770588|B1|Baseline|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
1019594|NCT00770588|P2|Participant Flow|Placebo|placebo 1 tablet daily
1019595|NCT00770588|P1|Participant Flow|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
1019596|NCT00770588|O2|Outcome|Placebo|Placebo 1 tablet daily
1019597|NCT00770588|O1|Outcome|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
1019598|NCT00770588|O2|Outcome|Placebo|placebo 1 tablet daily
1019599|NCT00770588|O1|Outcome|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
1019600|NCT00770588|O2|Outcome|Placebo|placebo 1 tablet daily
1019601|NCT00770588|O1|Outcome|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
1019602|NCT00770588|O2|Outcome|Placebo|placebo 1 tablet daily
1019603|NCT00770588|O1|Outcome|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
1019604|NCT00770588|O2|Outcome|Placebo|placebo 1 tablet daily
1019605|NCT00770588|O1|Outcome|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
1019606|NCT00770588|E2|Reported Event|Placebo|placebo 1 tablet daily
1019607|NCT00770588|E1|Reported Event|Gefitinib|Gefitinib (Iressa® 250 mg) 1 tablet daily
1019608|NCT00770562|B3|Baseline|Total|Total of all reporting groups
1019609|NCT00770562|B2|Baseline|Arm B: Dexamethasone + Rituximab|Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg per square meter (mg/m^2), IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets <20 x10^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with IgG IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
1019610|NCT00770562|B1|Baseline|Arm A: Dexamethasone|Participants received 40 mg dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of ≤20 x 10^9 platelets per liter (L; from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
1019611|NCT00770562|P2|Participant Flow|Arm B: Dexamethasone + Rituximab|Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets less than (<) 20 x10^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with immunoglobulin (IgG) IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
1019612|NCT00770562|P1|Participant Flow|Arm A: Dexamethasone|Participants received 40 milligrams (mg) dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of less than or equal to (≤)20 x 10^9 platelets per liter (L; from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg per square meter (mg/m^2), intravenously (IV), with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
1019613|NCT00770562|O2|Outcome|Arm B: Dexamethasone + Rituximab|Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets <20 x10^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with IgG IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
1019614|NCT00770562|O1|Outcome|Arm A: Dexamethasone|Participants received 40 mg dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of ≤20 x 10^9/L (from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
1019637|NCT00770510|O2|Outcome|Eszopiclone 1 mg|Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019638|NCT00770510|O1|Outcome|Placebo|Placebo tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019639|NCT00770510|O5|Outcome|Zolpidem Tartrate 10 mg|Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019615|NCT00770562|O2|Outcome|Arm B: Dexamethasone + Rituximab|Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets <20 x10^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with IgG IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
1019616|NCT00770562|O1|Outcome|Arm A: Dexamethasone|Participants received 40 mg dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of ≤20 x 10^9/L (from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
1019617|NCT00770562|O2|Outcome|Arm B: Dexamethasone + Rituximab|Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets <20 x10^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with IgG IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
1019618|NCT00770562|O1|Outcome|Arm A: Dexamethasone|Participants received 40 mg dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of ≤20 x 10^9/L (from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
1019619|NCT00770562|E3|Reported Event|Salvage Therapy|Nonresponsive (failed to achieve a sustained response) participants from Arm A (dexamethasone monotherapy) who had a platelet count of ≤20 x 10^9/L (from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants from Arm B (dexamethasone + rituximab) with platelets <20 x10^9/L or with active bleeding were treated with salvage therapy of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with IgG IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
1019620|NCT00770562|E2|Reported Event|Arm B: Dexamethasone + Rituximab|Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
1019621|NCT00770562|E1|Reported Event|Arm A: Dexamethasone|Participants received 40 mg dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4).
1019622|NCT00770510|B1|Baseline|Entire Study Population|"Includes groups randomized to receive one of 10 prespecified treatment sequence patterns which included receiving: Eszopiclone 1 mg first, Eszopiclone 2 mg first, Eszopiclone 3 mg first, Placebo first, and Zolpidem Tartrate 10 mg first.~Group 1: ABECD (n=7) Group 2: BCADE (n=7) Group 3: CDBEA (n=7) Group 4: DECAB (n=8) Group 5: EADBC (n=7) Group 6: DCEBA (n=8) Group 7: EDACB (n=7) Group 8: AEBDC (n=7) Group 9: BACED (n=7) Group 10: CBDAE (n=7)~A= Eszopiclone 3 mg; B= Eszopiclone 2 mg; C= Eszopiclone 1mg; D= Placebo; E: Zolpidem 10 mg"
1019623|NCT00770510|P1|Participant Flow|Entire Study Population|"Includes groups randomized to receive one of 10 prespecified treatment sequence patterns which included receiving: Eszopiclone 1 mg first, Eszopiclone 2 mg first, Eszopiclone 3 mg first, Placebo first, and Zolpidem Tartrate 10 mg first.~Group 1: ABECD (n=7) Group 2: BCADE (n=7) Group 3: CDBEA (n=7) Group 4: DECAB (n=8) Group 5: EADBC (n=7) Group 6: DCEBA (n=8) Group 7: EDACB (n=7) Group 8: AEBDC (n=7) Group 9: BACED (n=7) Group 10: CBDAE (n=7)~A= Eszopiclone 3 mg; B= Eszopiclone 2 mg; C= Eszopiclone 1mg; D= Placebo; E: Zolpidem 10 mg"
1019624|NCT00770510|O5|Outcome|Zolpidem Tartrate 10 mg|Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019625|NCT00770510|O4|Outcome|Eszopiclone 3 mg|Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019626|NCT00770510|O3|Outcome|Eszopiclone 2 mg|Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019627|NCT00770510|O2|Outcome|Eszopiclone 1 mg|Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019628|NCT00770510|O1|Outcome|Placebo|Placebo tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019629|NCT00770510|O5|Outcome|Zolpidem Tartrate 10 mg|Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019630|NCT00770510|O4|Outcome|Eszopiclone 3 mg|Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019631|NCT00770510|O3|Outcome|Eszopiclone 2 mg|Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019632|NCT00770510|O2|Outcome|Eszopiclone 1 mg|Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019633|NCT00770510|O1|Outcome|Placebo|Placebo tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019677|NCT00770367|B3|Baseline|Total|Total of all reporting groups
1019678|NCT00770367|B2|Baseline|Placebo|The analysis period during which participant took the placebo.
1019640|NCT00770510|O4|Outcome|Eszopiclone 3 mg|Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019641|NCT00770510|O3|Outcome|Eszopiclone 2 mg|Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019642|NCT00770510|O2|Outcome|Eszopiclone 1 mg|Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019643|NCT00770510|O1|Outcome|Placebo|Placebo tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019644|NCT00770510|O5|Outcome|Zolpidem Tartrate 10 mg|Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019645|NCT00770510|O4|Outcome|Eszopiclone 3 mg|Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019646|NCT00770510|O3|Outcome|Eszopiclone 2 mg|Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019647|NCT00770510|O2|Outcome|Eszopiclone 1 mg|Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019648|NCT00770510|O1|Outcome|Placebo|Placebo tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019649|NCT00770510|O5|Outcome|Zolpidem Tartrate 10 mg|Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019650|NCT00770510|O4|Outcome|Eszopiclone 3 mg|Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019651|NCT00770510|O3|Outcome|Eszopiclone 2 mg|Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019652|NCT00770510|O2|Outcome|Eszopiclone 1 mg|Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019653|NCT00770510|O1|Outcome|Placebo|Placebo tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019654|NCT00770510|E5|Reported Event|Zolpidem Tartrate 10 mg|Zolpidem Tartrate 10 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019655|NCT00770510|E4|Reported Event|Eszopiclone 3 mg|Eszopiclone 3 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019656|NCT00770510|E3|Reported Event|Eszopiclone 2 mg|Eszopiclone 2 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019657|NCT00770510|E2|Reported Event|Eszopiclone 1 mg|Eszopiclone 1 mg tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019658|NCT00770510|E1|Reported Event|Placebo|Placebo tablet taken orally at bedtime for 2 consecutive nights in one of 5 cross-over intervals in each of 10 prespecified treatment sequence patterns.
1019659|NCT00770484|B3|Baseline|Total|Total of all reporting groups
1019660|NCT00770484|B2|Baseline|Placebo Then Propranolol|"Placebo Treatment~Placebo then Propranolol: Placebo, matching pill given orally within 1 hour prior to exercising"
1019661|NCT00770484|B1|Baseline|Propranolol Then Placebo|"Active treatment~Propranolol then Placebo: Propanolol 20 mg, given orally within 1 hour prior to exercising"
1019662|NCT00770484|P2|Participant Flow|Placebo Then Propranolol|"Placebo Treatment~Placebo then Propranolol: Placebo, matching pill given orally within 1 hour prior to exercising"
1019663|NCT00770484|P1|Participant Flow|Propranolol Then Placebo|"Active treatment~Propranolol then Placebo: Propanolol 20 mg, given orally within 1 hour prior to exercising"
1019664|NCT00770484|O2|Outcome|Placebo|"Placebo Treatment~Placebo then Propranolol: Placebo, matching pill given orally within 1 hour prior to exercising"
1019665|NCT00770484|O1|Outcome|Propranolol|"Active treatment~Propranolol then Placebo: Propanolol 20 mg, given orally within 1 hour prior to exercising"
1019666|NCT00770484|E2|Reported Event|Placebo Then Propranolol|"Placebo Treatment~Placebo then Propranolol: Placebo, matching pill given orally within 1 hour prior to exercising"
1019667|NCT00770484|E1|Reported Event|Propranolol Then Placebo|"Active treatment~Propranolol then Placebo: Propanolol 20 mg, given orally within 1 hour prior to exercising"
1019668|NCT00770432|B3|Baseline|Total|Total of all reporting groups
1019669|NCT00770432|B2|Baseline|Placebo|MALTRIN 500® M500 (maltodextrin 500 powder for solution). Single dose (one capful) in 4 to 8 ounces of beverage for 7 days.
1019670|NCT00770432|B1|Baseline|Polyethylene Glycol 3350 Powder for Solution|MiraLAX® (polyethylene glycol 3350 powder for solution). Single dose (17 grams dissolved in 4 to 8 ounces of beverage) for 7 days.
1019671|NCT00770432|P2|Participant Flow|Placebo|MALTRIN 500® M500 (maltodextrin 500 powder for solution). Single dose (one capful) in 4 to 8 ounces of beverage for 7 days.
1019672|NCT00770432|P1|Participant Flow|Polyethylene Glycol 3350 Powder for Solution|MiraLAX® (polyethylene glycol 3350 powder for solution). Single dose (17 grams dissolved in 4 to 8 ounces of beverage) for 7 days.
1019673|NCT00770432|O2|Outcome|Placebo|MALTRIN 500® M500 (maltodextrin 500 powder for solution). Single dose (one capful) in 4 to 8 ounces of beverage for 7 days.
1019674|NCT00770432|O1|Outcome|Polyethylene Glycol 3350 Powder for Solution|MiraLAX® (polyethylene glycol 3350 powder for solution). Single dose (17 grams dissolved in 4 to 8 ounces of beverage) for 7 days.
1019675|NCT00770432|E2|Reported Event|Placebo|MALTRIN 500® M500 (maltodextrin 500 powder for solution). Single dose (one capful) in 4 to 8 ounces of beverage for 7 days.
1019676|NCT00770432|E1|Reported Event|Polyethylene Glycol 3350 Powder for Solution|MiraLAX® (polyethylene glycol 3350 powder for solution). Single dose (17 grams dissolved in 4 to 8 ounces of beverage) for 7 days.
1019679|NCT00770367|B1|Baseline|Pioglitazone|This is the analysis period during which participants took Pioglitazone.
1019680|NCT00770367|P2|Participant Flow|Placebo|The analysis period during which participant took the placebo.
1019681|NCT00770367|P1|Participant Flow|Pioglitazone|This is the analysis period during which participants took Pioglitazone.
1019682|NCT00770367|O2|Outcome|Placebo|The analysis period during which participant took the placebo.
1019683|NCT00770367|O1|Outcome|Pioglitazone|This is the analysis period during which participants took Pioglitazone.
1019684|NCT00770367|E2|Reported Event|Placebo|The analysis period during which participant took the placebo.
1019685|NCT00770367|E1|Reported Event|Pioglitazone|This is the analysis period during which participants took Pioglitazone.
1019686|NCT00770341|B4|Baseline|Total|Total of all reporting groups
1019687|NCT00770341|B3|Baseline|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
1019688|NCT00770341|B2|Baseline|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
1019689|NCT00770341|B1|Baseline|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
1019690|NCT00770341|P3|Participant Flow|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
1019691|NCT00770341|P2|Participant Flow|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
1019692|NCT00770341|P1|Participant Flow|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
1019693|NCT00770341|O3|Outcome|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
1019694|NCT00770341|O2|Outcome|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
1019695|NCT00770341|O1|Outcome|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
1019696|NCT00770341|O3|Outcome|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
1019697|NCT00770341|O2|Outcome|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
1019698|NCT00770341|O1|Outcome|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
1019699|NCT00770341|O3|Outcome|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
1019700|NCT00770341|O2|Outcome|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
1019701|NCT00770341|O1|Outcome|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
1019702|NCT00770341|O3|Outcome|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
1019703|NCT00770341|O2|Outcome|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
1019704|NCT00770341|O1|Outcome|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
1019705|NCT00770341|O3|Outcome|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
1019706|NCT00770341|O2|Outcome|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
1019707|NCT00770341|O1|Outcome|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
1019708|NCT00770341|O3|Outcome|MK-3009 (Daptomycin) 6 mg/kg|IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE)
1019709|NCT00770341|O2|Outcome|Vancomycin|IV Vancomycin 1 g twice daily for SSTI
1019710|NCT00770341|O1|Outcome|MK-3009 (Daptomycin) 4 mg/kg|Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI)
1019711|NCT00770341|E4|Reported Event|DAPTOMYCIN (6 MG/KG)|
1019712|NCT00770341|E3|Reported Event|VANCOMYCIN|
1019713|NCT00770341|E2|Reported Event|DAPTOMYCIN (4 MG/KG)|
1019714|NCT00770341|E1|Reported Event|NOT TREATED|
1019715|NCT00770315|B5|Baseline|Total|Total of all reporting groups
1019716|NCT00770315|B4|Baseline|Placebo|Participants receive placebo matching Ambrosia artemisiifolia allergan extract rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
1019717|NCT00770315|B3|Baseline|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
1019718|NCT00770315|B2|Baseline|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
1019719|NCT00770315|B1|Baseline|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
1019720|NCT00770315|P4|Participant Flow|Placebo|Participants receive placebo matching Ambrosia artemisiifolia allergan extract rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
1019721|NCT00770315|P3|Participant Flow|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
1019722|NCT00770315|P2|Participant Flow|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
1019723|NCT00770315|P1|Participant Flow|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
1019724|NCT00770315|O4|Outcome|Placebo|Participants receive matching placebo rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
1019725|NCT00770315|O3|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
1019726|NCT00770315|O2|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
1019927|NCT00769561|O2|Outcome|Occlusal Splint|Dental treatment with occlusal splint
1019727|NCT00770315|O1|Outcome|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
1019728|NCT00770315|O4|Outcome|Placebo|Participants receive matching placebo rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
1019729|NCT00770315|O3|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
1019730|NCT00770315|O2|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
1019731|NCT00770315|O1|Outcome|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
1019732|NCT00770315|O4|Outcome|Placebo|Participants receive matching placebo rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
1019733|NCT00770315|O3|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
1019734|NCT00770315|O2|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
1019735|NCT00770315|O1|Outcome|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
1019736|NCT00770315|O4|Outcome|Placebo|Participants receive matching placebo rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
1019737|NCT00770315|O3|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
1019738|NCT00770315|O2|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
1019739|NCT00770315|O1|Outcome|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
1019740|NCT00770315|O4|Outcome|Placebo|Participants receive matching placebo rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
1019741|NCT00770315|O3|Outcome|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
1019742|NCT00770315|O2|Outcome|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
1019743|NCT00770315|O1|Outcome|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
1019744|NCT00770315|E4|Reported Event|Placebo|Participants receive placebo matching Ambrosia artemisiifolia allergan extract rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
1019745|NCT00770315|E3|Reported Event|SCH 39641 12 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 12 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
1019746|NCT00770315|E2|Reported Event|SCH 39641 6 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 6 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
1019747|NCT00770315|E1|Reported Event|SCH 39641 1.5 Amb a 1-U|Participants receive Ambrosia artemisiifolia allergan extract (SCH 39641 1.5 Amb a 1-U) rapidly dissolving sublingual tablets, administered once daily for approximately 52 weeks
1019748|NCT00770289|B1|Baseline|All Participants|All participants diagnosed with major depressive disorder (MDD) who either started treatment with any anti-depressive agent for MDD for the first time or had a change in treatment as per physician's discretion.
1019749|NCT00770289|P1|Participant Flow|All Participants|All participants diagnosed with major depressive disorder (MDD) who either started treatment with any anti-depressive agent for MDD for the first time or had a change in treatment as per physician's discretion.
1019750|NCT00770289|O1|Outcome|All Participants|All participants diagnosed with major depressive disorder (MDD) who either started treatment with any anti-depressive agent for MDD for the first time or had a change in treatment as per physician's discretion and did not display remission.
1019751|NCT00770289|O3|Outcome|Beck Depression Inventory (BDI)|Participants who were administered BDI.
1019752|NCT00770289|O2|Outcome|Hamilton Depression Scale (HAM-D7)|Participants who were administered HAM-D7, a subset of clinician-administered rating scale HAM-D17.
1019753|NCT00770289|O1|Outcome|Hamilton Depression Scale (HAM-D17)|Participants who were administered HAM-D17.
1019754|NCT00770289|O1|Outcome|Beck Depression Inventory (BDI)|Participants who were administered BDI.
1019755|NCT00770289|O1|Outcome|Hamilton Depression Scale (HAM-D)|Participants who were administered Hamilton depression scales, HAM-D17 and HAM-D7.
1019756|NCT00770289|E1|Reported Event|All Participants|All participants diagnosed with major depressive disorder (MDD) who either started treatment with any anti-depressive agent for MDD for the first time or had a change in treatment as per physician's discretion.
1019757|NCT00770211|B3|Baseline|Total|Total of all reporting groups
1019758|NCT00770211|B2|Baseline|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
1019759|NCT00770211|B1|Baseline|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
1024996|NCT00758459|O1|Outcome|AZD1236|AZD1236
1019760|NCT00770211|P2|Participant Flow|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
1019761|NCT00770211|P1|Participant Flow|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
1019762|NCT00770211|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
1019763|NCT00770211|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
1019764|NCT00770211|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
1019765|NCT00770211|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
1019766|NCT00770211|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
1019767|NCT00770211|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
1019768|NCT00770211|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
1019769|NCT00770211|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
1019770|NCT00770211|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
1019771|NCT00770211|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
1019772|NCT00770211|E2|Reported Event|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin)
1019773|NCT00770211|E1|Reported Event|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
1019774|NCT00770146|B3|Baseline|Total|Total of all reporting groups
1019775|NCT00770146|B2|Baseline|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1019776|NCT00770146|B1|Baseline|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
1019777|NCT00770146|P2|Participant Flow|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1019778|NCT00770146|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
1019779|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1019780|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
1019781|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1019782|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
1019783|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1019784|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
1019785|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1019786|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
1019787|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1019788|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
1019789|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1019790|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
1019791|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1019792|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
1019793|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1019794|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
1019795|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1019796|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
1019797|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1019798|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
1019799|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1019800|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
1019801|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1019802|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
1019803|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1019804|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
1019805|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1019806|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
1019807|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1019808|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
1019809|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1019810|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
1019811|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1019812|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
1019813|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1019814|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
1019815|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1019816|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
1019817|NCT00770146|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1019818|NCT00770146|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
1019819|NCT00770146|E2|Reported Event|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1019820|NCT00770146|E1|Reported Event|Placebo|Participants received placebo subcutaneous injection once a week for 26 weeks.
1019821|NCT00770120|B1|Baseline|Everolimus|"Daily oral Everolimus 10 mg/day~everolimus"
1019822|NCT00770120|P1|Participant Flow|Everolimus|"Daily oral Everolimus 10 mg/day~everolimus"
1019823|NCT00770120|O1|Outcome|Everolimus|Daily oral Everolimus 10 mg/day
1019824|NCT00770120|O1|Outcome|Everolimus|"Daily oral Everolimus 10 mg/day~everolimus"
1019825|NCT00770120|O1|Outcome|Everolimus|"Daily oral Everolimus 10 mg/day~everolimus"
1019826|NCT00770120|O1|Outcome|Everolimus|"Daily oral Everolimus 10 mg/day~everolimus"
1019827|NCT00770120|E1|Reported Event|Everolimus|Daily oral Everolimus 10 mg/day
1019828|NCT00770029|B3|Baseline|Total|Total of all reporting groups
1019829|NCT00770029|B2|Baseline|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
1019830|NCT00770029|B1|Baseline|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
1019831|NCT00770029|P2|Participant Flow|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
1019832|NCT00770029|P1|Participant Flow|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
1019833|NCT00770029|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
1019834|NCT00770029|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
1019835|NCT00770029|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
1019836|NCT00770029|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
1019928|NCT00769561|O1|Outcome|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
1019837|NCT00770029|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
1019838|NCT00770029|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
1019839|NCT00770029|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
1019840|NCT00770029|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
1019841|NCT00770029|O2|Outcome|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
1019842|NCT00770029|O1|Outcome|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
1019843|NCT00770029|E2|Reported Event|Placebo|Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; mode of administration: same as for IncobotulinumtoxinA (Xeomin).
1019844|NCT00770029|E1|Reported Event|IncobotulinumtoxinA (Xeomin) (20 Units)|IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 20 units; mode of administration: intramuscular injection
1019845|NCT00769860|B3|Baseline|Total|Total of all reporting groups
1019846|NCT00769860|B2|Baseline|Placebo|Matched placebo pills, 100 mg TID for 4 months
1019847|NCT00769860|B1|Baseline|Arimoclomol|Arimoclomol 100 mg TID for 4 months
1019848|NCT00769860|P2|Participant Flow|Placebo|Matched placebo pills, 100 mg TID for 4 months
1019849|NCT00769860|P1|Participant Flow|Arimoclomol|Arimoclomol 100 mg TID for 4 months
1019850|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
1019851|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
1019852|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
1019853|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
1019854|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
1019855|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
1019856|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
1019857|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
1019858|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
1019859|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
1019860|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
1019861|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
1019862|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
1019863|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
1019864|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
1019865|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
1019866|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
1019867|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
1019868|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
1019869|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
1019870|NCT00769860|O2|Outcome|Placebo|Matched placebo pills, 100 mg TID for 4 months
1019871|NCT00769860|O1|Outcome|Arimoclomol|Arimoclomol 100 mg TID for 4 months
1019872|NCT00769860|E2|Reported Event|Placebo|Matched placebo pills, 100 mg TID for 4 months
1019873|NCT00769860|E1|Reported Event|Arimoclomol|Arimoclomol 100 mg TID for 4 months
1019874|NCT00769704|B3|Baseline|Total|Total of all reporting groups
1019875|NCT00769704|B2|Baseline|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
1019876|NCT00769704|B1|Baseline|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
1019877|NCT00769704|P2|Participant Flow|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose of talimogene laherparepvec was at a concentration of 10⁶ plaque forming units (PFU)/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
1024997|NCT00758459|O2|Outcome|Placebo|Placebo
1019878|NCT00769704|P1|Participant Flow|GM-CSF|Granulocyte macrophage colony-stimulating factor (GM-CSF) was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
1019879|NCT00769704|O2|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
1019880|NCT00769704|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
1019881|NCT00769704|O2|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ plaque forming units (PFU)/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
1019882|NCT00769704|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
1019883|NCT00769704|O2|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
1019884|NCT00769704|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
1019885|NCT00769704|O2|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
1019886|NCT00769704|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
1019887|NCT00769704|O2|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
1019888|NCT00769704|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
1019889|NCT00769704|O2|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
1019890|NCT00769704|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
1019891|NCT00769704|O2|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
1019892|NCT00769704|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
1019929|NCT00769561|E2|Reported Event|Occlusal Splint|Dental treatment with occlusal splint
1019893|NCT00769704|E2|Reported Event|Talimogene Laherparepvec|Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
1019894|NCT00769704|E1|Reported Event|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
1019895|NCT00769652|B3|Baseline|Total|Total of all reporting groups
1019896|NCT00769652|B2|Baseline|Standard Care|"Standard care~Standard Care : Standard nutritional care includes the National Cancer Institute's booklet Eating Hints for cancer patients: before, during & after treatment."
1019897|NCT00769652|B1|Baseline|Medical Nutrition Therapy|"Medical nutrition therapy~Medical nutrition therapy : Medical nutrition therapy (MNT) refers to intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule."
1019898|NCT00769652|P2|Participant Flow|Standard Care|"Standard care~Standard Care : Standard nutritional care includes the National Cancer Institute's booklet Eating Hints for cancer patients: before, during & after treatment."
1019899|NCT00769652|P1|Participant Flow|Medical Nutrition Therapy|"Medical nutrition therapy~Medical nutrition therapy : Medical nutrition therapy (MNT) refers to intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule."
1019900|NCT00769652|O2|Outcome|Standard Care|"Standard care~Standard Care : Standard nutritional care includes the National Cancer Institute's booklet Eating Hints for cancer patients: before, during & after treatment."
1019901|NCT00769652|O1|Outcome|Medical Nutrition Therapy|"Medical nutrition therapy~Medical nutrition therapy : Medical nutrition therapy (MNT) refers to intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule."
1019902|NCT00769652|O2|Outcome|Standard Care|"Standard care~Standard Care : Standard nutritional care includes the National Cancer Institute's booklet Eating Hints for cancer patients: before, during & after treatment."
1019903|NCT00769652|O1|Outcome|Medical Nutrition Therapy|"Medical nutrition therapy~Medical nutrition therapy : Medical nutrition therapy (MNT) refers to intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule."
1019904|NCT00769652|O2|Outcome|Standard Care|"Standard care~Standard Care : Standard nutritional care includes the National Cancer Institute's booklet Eating Hints for cancer patients: before, during & after treatment."
1019905|NCT00769652|O1|Outcome|Medical Nutrition Therapy|"Medical nutrition therapy~Medical nutrition therapy : Medical nutrition therapy (MNT) refers to intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule."
1019906|NCT00769652|E2|Reported Event|Standard Care|"Standard care~Standard Care : Standard nutritional care includes the National Cancer Institute's booklet Eating Hints for cancer patients: before, during & after treatment."
1019907|NCT00769652|E1|Reported Event|Medical Nutrition Therapy|"Medical nutrition therapy~Medical nutrition therapy : Medical nutrition therapy (MNT) refers to intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule."
1019908|NCT00769561|B3|Baseline|Total|Total of all reporting groups
1019909|NCT00769561|B2|Baseline|Occlusal Splint|Dental treatment with occlusal splint
1019910|NCT00769561|B1|Baseline|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
1019911|NCT00769561|P2|Participant Flow|Occlusal Splint|Dental treatment with occlusal splint
1019912|NCT00769561|P1|Participant Flow|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
1019913|NCT00769561|O2|Outcome|Occlusal Splint|Dental treatment with occlusal splint
1019914|NCT00769561|O1|Outcome|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
1019915|NCT00769561|O2|Outcome|Occlusal Splint|Dental treatment with occlusal splint
1019916|NCT00769561|O1|Outcome|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
1019917|NCT00769561|O2|Outcome|Occlusal Splint|Dental treatment with occlusal splint
1019918|NCT00769561|O1|Outcome|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
1019919|NCT00769561|O2|Outcome|Occlusal Splint|Dental treatment with occlusal splint
1019920|NCT00769561|O1|Outcome|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
1019921|NCT00769561|O2|Outcome|Occlusal Splint|Dental treatment with occlusal splint
1019922|NCT00769561|O1|Outcome|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
1019923|NCT00769561|O2|Outcome|Occlusal Splint|Dental treatment with occlusal splint
1019924|NCT00769561|O1|Outcome|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
1019925|NCT00769561|O2|Outcome|Occlusal Splint|Dental treatment with occlusal splint
1019926|NCT00769561|O1|Outcome|BFB-CBT|Biofeedback-based cognitive.behavioral treatment
1019932|NCT00769314|B2|Baseline|Placebo Group|muco-adhesive buccal tablet with placebo/Intent-to-Treat population
1019933|NCT00769314|B1|Baseline|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet/Intent-to-Treat population
1019934|NCT00769314|P2|Participant Flow|Placebo Group|muco-adhesive buccal tablet with placebo
1019935|NCT00769314|P1|Participant Flow|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
1019936|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
1019937|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
1019938|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
1019939|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
1019940|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
1019941|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
1019942|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
1019943|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
1019944|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
1019945|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
1019946|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
1019947|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
1019948|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
1019949|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
1019950|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
1019951|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
1019952|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
1019953|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
1019954|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
1019955|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
1019956|NCT00769314|O2|Outcome|Placebo Group|muco-adhesive buccal tablet with placebo
1019957|NCT00769314|O1|Outcome|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
1019958|NCT00769314|E2|Reported Event|Placebo Group|muco-adhesive buccal tablet with placebo
1019959|NCT00769314|E1|Reported Event|Acyclovir Lauriad Group|Acyclovir Lauriad 50mg muco-adhesive tablet
1019960|NCT00769184|B1|Baseline|Corticosteroid+LCD vs Corticosteroid+Placebo|"one side of body: corticosteroid and liquor carbonis distillate (LCD) treatment applied twice a day, for 2 weeks, then LCD-only twice a day, for 4 weeks, then no treatment for 6 weeks~opposite side of body: corticosteroid and placebo vehicle solution twice a day, for 2 weeks, then placebo vehicle solution-only twice a day, for 4 weeks, then no treatment for 6 weeks"
1019961|NCT00769184|P2|Participant Flow|Corticosteroid + LCD (Right), Corticosteroid + Placebo (Left)|"Corticosteroid + LCD on right side of body, Corticosteroid + Placebo on left side of body (n=8).~On right side: Corticosteroid + liquor carbonis distillate (LCD) treatment applied, twice a day, for 2 weeks, then LCD-only, twice a day, for 4 weeks, then no treatment for 6 weeks~On left side: Corticosteroid and placebo vehicle solution, twice a day, for 2 weeks, then placebo vehicle solution-only, twice a day, for 4 weeks, then no treatment for 6 weeks"
1019962|NCT00769184|P1|Participant Flow|Corticosteroid + LCD (Left), Corticosteroid + Placebo (Right)|"Corticosteroid + LCD on left side of body, Corticosteroid + Placebo on right side of body (n=7).~On left side: Corticosteroid + liquor carbonis distillate (LCD) treatment applied, twice a day, for 2 weeks, then LCD-only, twice a day, for 4 weeks, then no treatment for 6 weeks~On right side: Corticosteroid and placebo vehicle solution, twice a day, for 2 weeks, then placebo vehicle solution-only, twice a day, for 4 weeks, then no treatment for 6 weeks"
1019963|NCT00769184|O2|Outcome|Corticosteroid + Placebo|Corticosteroid + placebo solution applied to one side of body twice per day for 2 weeks. Then, placebo-only applied to one side of the body twice per day for 4 weeks.
1019964|NCT00769184|O1|Outcome|Corticosteroid + LCD|Corticosteroid + LCD solution applied to one side of body twice per day for 2 weeks. Then, LCD solution-only applied to one side of the body twice per day for 4 weeks.
1019965|NCT00769184|O2|Outcome|Corticosteroid + Placebo|Corticosteroid + placebo applied to one side of body twice per day for 2 weeks. Then, placebo-only applied to one side of the body twice per day for 4 weeks.
1019966|NCT00769184|O1|Outcome|Corticosteroid + LCD|Corticosteroid + LCD solution applied to one side of body twice per day for 2 weeks. Then, LCD solution- only applied to one side of the body twice per day for 4 weeks.
1019967|NCT00769184|E2|Reported Event|Corticosteroid + Placebo|Corticosteroid + placebo applied to one side of body twice per day for 2 weeks. Then, placebo-only applied to one side of the body twice per day for 4 weeks.
1019968|NCT00769184|E1|Reported Event|Corticosteroid + LCD|Corticosteroid + LCD solution applied to one side of body twice per day for 2 weeks. Then, LCD solution- only applied to one side of the body twice per day for 4 weeks.
1019969|NCT00769132|B1|Baseline|Totals for Study|All participants in the study.
1019970|NCT00769132|P4|Participant Flow|Sequence 4: A/D/B/C|"A = ER niacin 2 g/laropiprant 40 mg once daily for 7 days~B = ER niacin 2 g once daily for 7 days~C = laropiprant 40 mg once daily for 7 days~D = placebo once daily for 7 days"
1019971|NCT00769132|P3|Participant Flow|Sequence 3: B/A/C/D|"A = ER niacin 2 g/laropiprant 40 mg once daily for 7 days B = ER niacin 2 g once daily for 7 days~C = laropiprant 40 mg once daily for 7 days~D = placebo once daily for 7 days"
1019972|NCT00769132|P2|Participant Flow|Sequence 2: C/B/D/A|"A = ER niacin 2 g/laropiprant 40 mg once daily for 7 days B = ER niacin 2 g once daily for 7 days~C = laropiprant 40 mg once daily for 7 days~D = placebo once daily for 7 days"
1019973|NCT00769132|P1|Participant Flow|Sequence 1: D/C/A/B|"A = Extended Release (ER) niacin 2 g/laropiprant 40 mg once daily for 7 days~B = ER niacin 2 g once daily for 7 days~C = laropiprant 40 mg once daily for 7 days~D = placebo once daily for 7 days"
1019974|NCT00769132|O4|Outcome|Placebo|Placebo daily for 7 days
1019975|NCT00769132|O3|Outcome|Laropiprant 40 mg|Laropiprant 40 mg once daily for 7 days
1019976|NCT00769132|O2|Outcome|ER Niacin 2 g|ER niacin 2 g daily for 7 days
1019977|NCT00769132|O1|Outcome|ER Niacin 2 g / Laropiprant 40 mg|ER niacin 2 g/laropiprant 40 mg daily for 7 days
1019978|NCT00769132|O4|Outcome|Placebo|Placebo daily for 7 days
1019979|NCT00769132|O3|Outcome|Laropiprant 40 mg|Laropiprant 40 mg once daily for 7 days
1019980|NCT00769132|O2|Outcome|ER Niacin 2 g|ER niacin 2 g daily for 7 days
1019981|NCT00769132|O1|Outcome|ER Niacin 2 g / Laropiprant 40 mg|ER niacin 2 g/laropiprant 40 mg daily for 7 days
1019982|NCT00769132|E4|Reported Event|Placebo|Placebo once daily for 7 days
1019983|NCT00769132|E3|Reported Event|Laropiprant 40 mg|Laropiprant 40 mg once daily for 7 days
1019984|NCT00769132|E2|Reported Event|ER Niacin 2 g|ER niacin 2 g once daily for 7 days
1019985|NCT00769132|E1|Reported Event|ER Niacin 2 g / Laropiprant 40 mg|ER niacin 2 g/laropiprant 40 mg once daily for 7 days
1019986|NCT00769119|B3|Baseline|Total|Total of all reporting groups
1019987|NCT00769119|B2|Baseline|Placebo|Placebo, 2 tablets twice daily (bid)
1019988|NCT00769119|B1|Baseline|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1019989|NCT00769119|P2|Participant Flow|Placebo|Placebo, 2 tablets twice daily (bid)
1019990|NCT00769119|P1|Participant Flow|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1019991|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
1019992|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1019993|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
1019994|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1019995|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
1019996|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1019997|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
1019998|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1019999|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
1020000|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1020001|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
1020002|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1020003|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
1020004|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1020005|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
1020006|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1020007|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
1020008|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1020009|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
1020010|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1020011|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
1020012|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1020013|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
1020014|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1020015|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
1020016|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1020017|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
1020018|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1020019|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
1020020|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1020021|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
1020022|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1020023|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
1020024|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1020025|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
1020026|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1020027|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
1020028|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1020029|NCT00769119|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
1020030|NCT00769119|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1020031|NCT00769119|E2|Reported Event|Placebo|Placebo, 2 tablets twice daily (bid)
1020032|NCT00769119|E1|Reported Event|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1020033|NCT00769067|B3|Baseline|Total|Total of all reporting groups
1020034|NCT00769067|B2|Baseline|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
1020035|NCT00769067|B1|Baseline|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
1020036|NCT00769067|P2|Participant Flow|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
1020037|NCT00769067|P1|Participant Flow|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
1020038|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
1020039|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
1020040|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
1020041|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
1020042|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
1020043|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
1020044|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
1020045|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
1020046|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
1020047|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
1020048|NCT00769067|O1|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
1020049|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
1020050|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
1020051|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
1020052|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
1020053|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
1020054|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
1020055|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
1020056|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
1020057|NCT00769067|O2|Outcome|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
1020058|NCT00769067|O1|Outcome|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
1020059|NCT00769067|E2|Reported Event|Dacomitinib|Dacomitinib (PF-00299804) 45 mg tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
1020060|NCT00769067|E1|Reported Event|Erlotinib|Erlotinib 150 milligram (mg) tablet orally once daily continuously in 28-day cycles until unacceptable toxicity, tumor progression or death.
1020061|NCT00769015|B3|Baseline|Total|Total of all reporting groups
1020062|NCT00769015|B2|Baseline|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
1020063|NCT00769015|B1|Baseline|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
1020064|NCT00769015|P2|Participant Flow|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
1020065|NCT00769015|P1|Participant Flow|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
1020066|NCT00769015|O2|Outcome|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
1020067|NCT00769015|O1|Outcome|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
1020068|NCT00769015|O2|Outcome|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
1020069|NCT00769015|O1|Outcome|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
1020070|NCT00769015|O2|Outcome|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
1020071|NCT00769015|O1|Outcome|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
1020072|NCT00769015|O2|Outcome|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
1020073|NCT00769015|O1|Outcome|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
1020074|NCT00769015|O2|Outcome|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
1020075|NCT00769015|O1|Outcome|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
1020076|NCT00769015|O2|Outcome|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
1020077|NCT00769015|O1|Outcome|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
1020078|NCT00769015|O2|Outcome|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
1020079|NCT00769015|O1|Outcome|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
1020080|NCT00769015|E2|Reported Event|ST-LVR|"Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.~ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy"
1020121|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
1020081|NCT00769015|E1|Reported Event|BA-LVR|"In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.~BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits"
1020082|NCT00768989|B3|Baseline|Total|Total of all reporting groups
1020083|NCT00768989|B2|Baseline|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
1020084|NCT00768989|B1|Baseline|Atazanavir + Raltegravir|Atazanavir 300 mg twice daily plus Raltegravir 400 mg twice daily
1020085|NCT00768989|P2|Participant Flow|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
1020086|NCT00768989|P1|Participant Flow|Atazanavir + Raltegravir|Atazanavir 300 mg twice daily plus Raltegravir 400 mg twice daily
1020087|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
1020088|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
1020089|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
1020090|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
1020091|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
1020092|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
1020093|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
1020094|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
1020095|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
1020096|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
1020097|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
1020098|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
1020099|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
1020100|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
1020101|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
1020102|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
1020103|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
1020104|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
1020105|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
1020106|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
1020107|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
1020108|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
1020109|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
1020110|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
1020111|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
1020112|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
1020113|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
1020114|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir 300 mg twice daily plus Raltegravir 400 mg twice daily
1020115|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
1020116|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
1020117|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
1020118|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
1020119|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
1020120|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir 400 mg twice daily
1020122|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
1020123|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
1020124|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
1020125|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
1020126|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir 400 mg twice daily
1020127|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
1020128|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
1020129|NCT00768989|O2|Outcome|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
1020130|NCT00768989|O1|Outcome|Atazanavir + Raltegravir|Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
1020131|NCT00768989|E2|Reported Event|Atazanavir + Raltegravir|Atazanavir 300 mg twice daily plus Raltegravir 400 mg twice daily
1020132|NCT00768989|E1|Reported Event|Atazanavir + Ritonavir + Tenofovir/Emtricitabine|Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/Emtricitabine, 300 mg/200 mg once daily
1020133|NCT00768898|B1|Baseline|Overall|All enrolled participants
1020134|NCT00768898|P1|Participant Flow|Overall|All enrolled participants
1020135|NCT00768898|O3|Outcome|10.0 Microliters Lissamine Green|10.0 microliters lissamine green instilled in each eye
1020136|NCT00768898|O2|Outcome|5.0 Microliters Lissamine Green|5.0 microliters lissamine green instilled in each eye
1020137|NCT00768898|O1|Outcome|2.5 Microliters Lissamine Green|2.5 microliters lissamine green instilled in each eye
1020138|NCT00768898|O3|Outcome|10.0 Microliters Lissamine Green|10.0 microliters lissamine green instilled in each eye
1020139|NCT00768898|O2|Outcome|5.0 Microliters Lissamine Green|5.0 microliters lissamine green instilled in each eye
1020140|NCT00768898|O1|Outcome|2.5 Microliters Lissamine Green|2.5 microliters lissamine green instilled in each eye
1020141|NCT00768898|O3|Outcome|10.0 Microliters Lissamine Green|10.0 microliters lissamine green instilled in each eye
1020142|NCT00768898|O2|Outcome|5.0 Microliters Lissamine Green|5.0 microliters lissamine green instilled in each eye
1020143|NCT00768898|O1|Outcome|2.5 Microliters Lissamine Green|2.5 microliters lissamine green instilled in each eye
1020144|NCT00768898|O3|Outcome|10.0 Microliters Lissamine Green|10.0 microliters lissamine green instilled in each eye
1020145|NCT00768898|O2|Outcome|5.0 Microliters Lissamine Green|5.0 microliters lissamine green instilled in each eye
1020146|NCT00768898|O1|Outcome|2.5 Microliters Lissamine Green|2.5 microliters lissamine green instilled in each eye
1020147|NCT00768898|O3|Outcome|10.0 Microliters Lissamine Green|10.0 microliters lissamine green instilled in each eye
1020148|NCT00768898|O2|Outcome|5.0 Microliters Lissamine Green|5.0 microliters lissamine green instilled in each eye
1020149|NCT00768898|O1|Outcome|2.5 Microliters Lissamine Green|2.5 microliters lissamine green were instilled in each eye.
1020150|NCT00768898|E3|Reported Event|10.0 Microliters Lissamine Green|10.0 microliters lissamine green
1020151|NCT00768898|E2|Reported Event|5.0 Microliters Lissamine Green|5.0 microliters lissamine green
1020152|NCT00768898|E1|Reported Event|2.5 Microliters Lissamine Green|2.5 microliters lissamine green
1020153|NCT00768755|B5|Baseline|Total|Total of all reporting groups
1020154|NCT00768755|B4|Baseline|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
1020155|NCT00768755|B3|Baseline|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
1020156|NCT00768755|B2|Baseline|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
1020157|NCT00768755|B1|Baseline|Axitinib + Pemetrexed/Cisplatin (Phase 1)|Lead-in axitinib (AG-013736) tablet at a starting dose of 5 milligram (mg) orally twice daily (BID) from Day -5, -4 or -3 till Day 18 of Cycle 1 then continuously from Day 3 of Cycle 2 along with pemetrexed 500 milligram per square meter (mg/m^2) infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable adverse events (AEs), or participant withdrawal.
1020158|NCT00768755|P4|Participant Flow|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
1020173|NCT00768755|O1|Outcome|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
1020159|NCT00768755|P3|Participant Flow|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
1020160|NCT00768755|P2|Participant Flow|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
1020161|NCT00768755|P1|Participant Flow|Axitinib + Pemetrexed/Cisplatin (Phase 1)|Lead-in axitinib (AG-013736) tablet at a starting dose of 5 milligram (mg) orally twice daily (BID) from Day -5, -4 or -3 till Day 18 of Cycle 1 then continuously from Day 3 of Cycle 2 along with pemetrexed 500 milligram per square meter (mg/m^2) infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable adverse events (AEs), or participant withdrawal.
1020162|NCT00768755|O3|Outcome|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
1020163|NCT00768755|O2|Outcome|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
1020164|NCT00768755|O1|Outcome|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
1020165|NCT00768755|O3|Outcome|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
1020166|NCT00768755|O2|Outcome|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
1020167|NCT00768755|O1|Outcome|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
1020168|NCT00768755|O3|Outcome|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
1020169|NCT00768755|O2|Outcome|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
1020170|NCT00768755|O1|Outcome|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
1020171|NCT00768755|O3|Outcome|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
1020172|NCT00768755|O2|Outcome|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
1020174|NCT00768755|O3|Outcome|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
1020175|NCT00768755|O2|Outcome|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
1020176|NCT00768755|O1|Outcome|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
1020177|NCT00768755|O3|Outcome|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
1020178|NCT00768755|O2|Outcome|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
1020179|NCT00768755|O1|Outcome|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
1020180|NCT00768755|E4|Reported Event|Pemetrexed/Cisplatin (Phase 2)|Pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
1020181|NCT00768755|E3|Reported Event|Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID from Day 2-19 in cycles of chemotherapy phase, except the last cycle, where axitinib (AG-013736) was administered on Day 2-21 along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
1020182|NCT00768755|E2|Reported Event|Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2)|Axitinib (AG-013736) tablet at a starting dose of 5 mg orally BID along with pemetrexed 500 mg/m^2 infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable AEs, or participant withdrawal.
1020183|NCT00768755|E1|Reported Event|Axitinib + Pemetrexed/Cisplatin (Phase 1)|Lead-in axitinib (AG-013736) tablet at a starting dose of 5 milligram (mg) orally twice daily (BID) from Day -5, -4 or -3 till Day 18 of Cycle 1 then continuously from Day 3 of Cycle 2 along with pemetrexed 500 milligram per square meter (mg/m^2) infusion and cisplatin 75 mg/m^2 infusion over a 2 hour period on Day 1 of each cycle up to 6 cycles of length 21 days each in chemotherapy phase and axitinib (AG-013736) tablet 5 mg orally BID in single-agent maintenance phase. Treatment was continued until progression of disease, unmanageable adverse events (AEs), or participant withdrawal.
1020184|NCT00768651|B1|Baseline|One Arm: Sitagliptin + Pantoprazole|"Intervention Details:~Sitagliptin 100 mg daily and Pantoprazole 40 mg bid for 6 months, followed by a three-month washout:~Pantoprazole: Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months.~Sitagliptin: Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months."
1020185|NCT00768651|P1|Participant Flow|Sitagliptin + Pantoprazole|"Intervention Details:~Pantoprazole: Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months, followed by a three-month washout.~Sitagliptin: Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months, followed by a three-month washout."
1020186|NCT00768651|O1|Outcome|One Arm: Sitagliptin + Pantoprazole|"Intervention Details:~Sitagliptin 100 mg daily and Pantoprazole 40 mg bid for 6 months, followed by a three-month washout.~Pantoprazole: Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months.~Sitagliptin: Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months."
1020187|NCT00768651|O1|Outcome|One Arm: Sitagliptin + Pantoprazole|"Intervention Details:~Sitagliptin 100 mg daily and Pantoprazole 40 mg bid for 6 months, followed by a three-month washout:~Pantoprazole: Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months.~Sitagliptin: Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months."
1020188|NCT00768651|E1|Reported Event|One Arm: Sitagliptin + Pantoprazole|"Intervention Details:~Sitagliptin 100 mg daily and Pantoprazole 40 mg bid for 6 months, followed by a three-month washout:~Pantoprazole: Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months.~Sitagliptin: Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months."
1020189|NCT00768599|B4|Baseline|Total|Total of all reporting groups
1020190|NCT00768599|B3|Baseline|Control|Vehicle Foam
1020191|NCT00768599|B2|Baseline|Test Drug|Econazole Nitrate Foam 1%
1020192|NCT00768599|B1|Baseline|Reference Drug|Econazole Nitrate Cream 1%
1020219|NCT00768560|B5|Baseline|Nifedipine 80 mg OD x 40 mg OD x 40 mg BID for 2 Weeks Each|
1020220|NCT00768560|B4|Baseline|Nifedipine 40 mg BID x 40 mg OD x 80 mg OD for 2 Weeks Each|
1020221|NCT00768560|B3|Baseline|Nifedipine 40 mg BID x 80 mg OD x 40 mg OD for 2 Weeks Each|
1020222|NCT00768560|B2|Baseline|Nifedipine 40 mg OD x 80 mg OD x 40 mg BID for 2 Weeks Each|
1020223|NCT00768560|B1|Baseline|Nifedipine 40 mg OD x 40 mg BID x 80 mg OD for 2 Weeks Each|
1020224|NCT00768560|P6|Participant Flow|Nifedipine 80 mg OD x 40 mg BID x 40 mg OD for 2 Weeks Each|
1020225|NCT00768560|P5|Participant Flow|Nifedipine 80 mg OD x 40 mg OD x 40 mg BID for 2 Weeks Each|
1020226|NCT00768560|P4|Participant Flow|Nifedipine 40 mg BID x 40 mg OD x 80 mg OD for 2 Weeks Each|
1020227|NCT00768560|P3|Participant Flow|Nifedipine 40 mg BID x 80 mg OD x 40 mg OD for 2 Weeks Each|
1020228|NCT00768560|P2|Participant Flow|Nifedipine 40 mg OD x 80 mg OD x 40 mg BID for 2 Weeks Each|
1020229|NCT00768560|P1|Participant Flow|Nifedipine 40 mg OD x 40 mg BID x 80 mg OD for 2 Weeks Each|
1020230|NCT00768560|O3|Outcome|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
1020231|NCT00768560|O2|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
1020232|NCT00768560|O1|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
1020233|NCT00768560|O3|Outcome|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
1020234|NCT00768560|O2|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
1020235|NCT00768560|O1|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
1020236|NCT00768560|O3|Outcome|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
1020237|NCT00768560|O2|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
1020238|NCT00768560|O1|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
1020239|NCT00768560|O3|Outcome|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
1020240|NCT00768560|O2|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
1020241|NCT00768560|O1|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
1020242|NCT00768560|O3|Outcome|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
1020243|NCT00768560|O2|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
1020244|NCT00768560|O1|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
1020245|NCT00768560|O3|Outcome|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
1020246|NCT00768560|O2|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
1020247|NCT00768560|O1|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
1020248|NCT00768560|O3|Outcome|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
1020249|NCT00768560|O2|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
1020250|NCT00768560|O1|Outcome|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
1020251|NCT00768560|E3|Reported Event|Nifedipine (Adalat CR, BAYA1040) 80 mg OD|Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning
1020252|NCT00768560|E2|Reported Event|Nifedipine (Adalat CR, BAYA1040) 40 mg BID|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening
1020253|NCT00768560|E1|Reported Event|Nifedipine (Adalat CR, BAYA1040) 40 mg OD|Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
1020254|NCT00768521|B1|Baseline|All Participants|All Study Participants from all groups.
1020255|NCT00768521|P2|Participant Flow|Placebo Then Tolterodine|Placebo then Tolterodine 4 mg
1020256|NCT00768521|P1|Participant Flow|Tolterodine Then Placebo|Tolterodine 4 mg then Placebo
1020257|NCT00768521|O2|Outcome|Placebo|
1020258|NCT00768521|O1|Outcome|Tolterodine|Tolterodine 4 mg
1020259|NCT00768521|O2|Outcome|Placebo|
1020260|NCT00768521|O1|Outcome|Tolterodine|Tolterodine 4 mg
1020261|NCT00768521|E2|Reported Event|Placebo|
1020262|NCT00768521|E1|Reported Event|Tolterodine|Tolterodine 4 mg
1020263|NCT00768430|B3|Baseline|Total|Total of all reporting groups
1020264|NCT00768430|B2|Baseline|Midazolam|Midazolam
1020265|NCT00768430|B1|Baseline|Ketamine|Ketamine
1020266|NCT00768430|P2|Participant Flow|Midazolam|single infusion of midazolam being used as an active control for the study
1020267|NCT00768430|P1|Participant Flow|Ketamine|single infusion of 0.5mg/kg of Ketamine HCL
1020268|NCT00768430|O2|Outcome|Midazolam|Midazolam
1020269|NCT00768430|O1|Outcome|Ketamine|Ketamine
1020270|NCT00768430|E2|Reported Event|Midazolam|Midazolam
1020271|NCT00768430|E1|Reported Event|Ketamine|Ketamine
1020272|NCT00768300|B3|Baseline|Total|Total of all reporting groups
1020273|NCT00768300|B2|Baseline|Placebo|Placebo to match ambrisentan administered orally once daily
1020274|NCT00768300|B1|Baseline|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
1020275|NCT00768300|P2|Participant Flow|Placebo|Placebo to match ambrisentan administered orally once daily
1020276|NCT00768300|P1|Participant Flow|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
1020277|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
1020278|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
1020279|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
1020280|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
1020281|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
1020282|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
1020283|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
1020284|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
1020285|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
1020286|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
1020287|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
1020288|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
1020289|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
1020290|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
1020291|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
1020292|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
1020293|NCT00768300|O2|Outcome|Placebo|Placebo to match ambrisentan administered orally once daily
1020294|NCT00768300|O1|Outcome|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
1020295|NCT00768300|E2|Reported Event|Placebo|Placebo to match ambrisentan administered orally once daily
1020296|NCT00768300|E1|Reported Event|Ambrisentan|Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
1020297|NCT00768222|B3|Baseline|Total|Total of all reporting groups
1020298|NCT00768222|B2|Baseline|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
1020299|NCT00768222|B1|Baseline|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
1020300|NCT00768222|P2|Participant Flow|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
1020301|NCT00768222|P1|Participant Flow|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
1020302|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
1020303|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
1020304|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
1020305|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
1020306|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
1020307|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
1020308|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
1020309|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
1020310|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
1020311|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
1020312|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
1020313|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
1020314|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
1020315|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
1020316|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
1020317|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
1020318|NCT00768222|O2|Outcome|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
1020319|NCT00768222|O1|Outcome|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
1020320|NCT00768222|E2|Reported Event|VICRYL* Plus Suture|Synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide and containing triclosan antibacterial, used in a subcuticular closure technique
1020321|NCT00768222|E1|Reported Event|Chinese Silk Suture|Natural, non-absorbable silk suture made from entwined thread from silkworm larva, commercially available in China, used in a simple interrupted transdermal suture pattern
1020322|NCT00768144|B1|Baseline|Sunitinib|Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.
1020323|NCT00768144|P1|Participant Flow|Sunitinib|Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.
1020324|NCT00768144|O1|Outcome|Sunitinib|Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.
1020325|NCT00768144|O1|Outcome|Sunitinib|Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.
1020326|NCT00768144|O1|Outcome|Sunitinib|Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.
1020327|NCT00768144|E1|Reported Event|Sunitinib|Sunitinib : Taken orally once a day in the evening
1020328|NCT00768118|B1|Baseline|Biomarker Alterations by Nutritional Labels|Participants will donate a blood sample (pre & post intervention), two-3 tsp size tubes of blood will be collected in CPT tubes during each blood draw. Urine sample (pre & post intervention). During the 2-wk intervention period, the participant will be ingesting a nutritional supplement. Two capsules taken orally twice daily with meals, no other tests will be performed.
1020329|NCT00768118|P1|Participant Flow|Biomarker Alterations by Nutritional Labels|Participants will donate a blood sample (pre & post intervention), two-3 tsp size tubes of blood will be collected in CPT tubes during each blood draw. Urine sample (pre & post intervention). During the 2-wk intervention period, the participant will be ingesting a nutritional supplement. Two capsules taken orally twice daily with meals, no other tests will be performed.
1020330|NCT00768118|O1|Outcome|Biomarker Alterations by Nutritional Labels|Participants will donate a blood sample (pre & post intervention), two-3 tsp size tubes of blood will be collected in CPT tubes during each blood draw. Urine sample (pre & post intervention). During the 2-wk intervention period, the participant will be ingesting a nutritional supplement. Two capsules taken orally twice daily with meals, no other tests will be performed.
1020331|NCT00768118|E1|Reported Event|Biomarker Alterations by Nutritional Labels|Participants will donate a blood sample (pre & post intervention), two-3 tsp size tubes of blood will be collected in CPT tubes during each blood draw. Urine sample (pre & post intervention). During the 2-wk intervention period, the participant will be ingesting a nutritional supplement. Two capsules taken orally twice daily with meals, no other tests will be performed.
1020332|NCT00768066|B4|Baseline|Total|Total of all reporting groups
1020333|NCT00768066|B3|Baseline|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020334|NCT00768066|B2|Baseline|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020335|NCT00768066|B1|Baseline|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020336|NCT00768066|P3|Participant Flow|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020337|NCT00768066|P2|Participant Flow|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020338|NCT00768066|P1|Participant Flow|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020339|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020340|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020830|NCT00766415|P1|Participant Flow|AZD1981|AZD1981 1000 mg, twice daily
1020341|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020342|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020343|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020344|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020345|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020346|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020347|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020348|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020349|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020350|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020351|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020352|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020353|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020354|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020355|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020356|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020357|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020358|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020359|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020360|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020361|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020362|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020363|NCT00768066|O3|Outcome|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020364|NCT00768066|O2|Outcome|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020365|NCT00768066|O1|Outcome|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020366|NCT00768066|E3|Reported Event|Participants Will Receive a Placebo Injection of Phosphate-buf|Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020367|NCT00768066|E2|Reported Event|200 Million Autologous Human Bone Marrow Cells (hBMCs)|Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020368|NCT00768066|E1|Reported Event|200 Million Autologous Human Mesenchymal Stem Cells (hMSCs)|Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
1020369|NCT00768053|B1|Baseline|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
1020370|NCT00768053|P1|Participant Flow|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
1020371|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
1020372|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
1020373|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
1020374|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
1020375|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
1020376|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
1020377|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
1020378|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
1020379|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
1020380|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
1020381|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
1020382|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
1020383|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
1020384|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
1020385|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
1020386|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
1020387|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
1020388|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
1020389|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
1020442|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
1020390|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
1020391|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
1020392|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
1020393|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
1020394|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
1020395|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
1020396|NCT00768053|O1|Outcome|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
1020397|NCT00768053|E1|Reported Event|Etanercept (ETN)|Subcutaneous (sc) injection once weekly using the 50 milligram (mg) pre-filled syringe during the 12-week treatment phase.
1020398|NCT00768040|B3|Baseline|Total|Total of all reporting groups
1020399|NCT00768040|B2|Baseline|Placebo|Matching placebo once daily for 12 weeks
1020400|NCT00768040|B1|Baseline|Aliskiren 300 mg|Aliskiren 300 mg once daily for 12 weeks
1020401|NCT00768040|P2|Participant Flow|Placebo|Matching placebo once daily for 12 weeks
1020402|NCT00768040|P1|Participant Flow|Aliskiren 300 mg|Aliskiren 300 mg once daily for 12 weeks
1020403|NCT00768040|O2|Outcome|Placebo|Matching placebo once daily for 12 weeks
1020404|NCT00768040|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg once daily for 12 weeks
1020405|NCT00768040|E2|Reported Event|Placebo|Matching placebo once daily for 12 weeks
1020406|NCT00768040|E1|Reported Event|Aliskiren 300mg|Aliskiren 300 mg once daily for 12 weeks
1020407|NCT00767806|B3|Baseline|Total|Total of all reporting groups
1020408|NCT00767806|B2|Baseline|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
1020409|NCT00767806|B1|Baseline|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
1020410|NCT00767806|P2|Participant Flow|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
1020411|NCT00767806|P1|Participant Flow|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
1020412|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
1020413|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
1020414|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
1020415|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
1020416|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
1020417|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
1020418|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
1020419|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
1020420|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
1020421|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
1020422|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
1020423|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
1020424|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
1020425|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
1020426|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
1020427|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
1020428|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
1020429|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
1020430|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
1020431|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
1020432|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
1020433|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
1020434|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
1020435|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
1020436|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
1020437|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
1020438|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
1020439|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
1020440|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
1020441|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
1020443|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
1020444|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
1020445|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
1020446|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
1020447|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
1020448|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
1020449|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
1020450|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
1020451|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
1020452|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
1020453|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
1020454|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
1020455|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
1020456|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
1020457|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
1020458|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
1020459|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
1020460|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
1020461|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
1020462|NCT00767806|O2|Outcome|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
1020463|NCT00767806|O1|Outcome|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
1020464|NCT00767806|E2|Reported Event|Placebo|Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
1020465|NCT00767806|E1|Reported Event|Duloxetine|Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
1020466|NCT00767767|B6|Baseline|Total|Total of all reporting groups
1020467|NCT00767767|B5|Baseline|Thiopental 3mcg/mL|"Anesthetic Drug Infusion~Thiopental 3mcg/mL: IV Thiopental Infusion for 2 hours."
1020468|NCT00767767|B4|Baseline|Thiopental 1.5mcg/mL|"Anesthetic Drug Infusion~Thiopental 1.5mcg/mL: IV Thiopental infusion for 2 hours."
1020469|NCT00767767|B3|Baseline|Propofol 0.9mcg/mL|"Anesthetic Drug Infusion~Propofol 0.9mcg/mL: IV Propfol infusion for 2 hours."
1020470|NCT00767767|B2|Baseline|Propofol 0.45mcg/mL|"Anesthetic Drug Infusion~Propofol 0.45mcg/mL: IV Propofol infusion for 2 hours."
1020471|NCT00767767|B1|Baseline|Placebos|"Saline Infusion~Placebos: IV Saline infusion for 2 hours."
1020472|NCT00767767|P5|Participant Flow|Thiopental 3mcg/mL|"Anesthetic Drug Infusion~Thiopental 3mcg/mL: IV Thiopental Infusion for 2 hours."
1020473|NCT00767767|P4|Participant Flow|Thiopental 1.5mcg/mL|"Anesthetic Drug Infusion~Thiopental 1.5mcg/mL: IV Thiopental infusion for 2 hours."
1020474|NCT00767767|P3|Participant Flow|Propofol 0.9mcg/mL|"Anesthetic Drug Infusion~Propofol 0.9mcg/mL: IV Propofol infusion for 2 hours."
1020475|NCT00767767|P2|Participant Flow|Propofol 0.45mcg/mL|"Anesthetic Drug Infusion~Propofol 0.45mcg/mL: IV Propofol infusion for 2 hours."
1020476|NCT00767767|P1|Participant Flow|Placebos|"Saline Infusion~Placebos: IV Saline infusion for 2 hours."
1020477|NCT00767767|O5|Outcome|Thiopental 3mcg/mL|"Anesthetic Drug Infusion~Thiopental 3mcg/mL: IV Thiopental Infusion for 2 hours."
1020478|NCT00767767|O4|Outcome|Thiopental 1.5mcg/mL|"Anesthetic Drug Infusion~Thiopental 1.5mcg/mL: IV Thiopental infusion for 2 hours."
1020479|NCT00767767|O3|Outcome|Propofol 0.9mcg/mL|"Anesthetic Drug Infusion~Propofol 0.9mcg/mL: IV Propfol infusion for 2 hours."
1020480|NCT00767767|O2|Outcome|Propofol 0.45mcg/mL|"Anesthetic Drug Infusion~Propofol 0.45mcg/mL: IV Propofol infusion for 2 hours."
1020481|NCT00767767|O1|Outcome|Placebos|"Saline Infusion~Placebos: IV Saline infusion for 2 hours."
1020482|NCT00767767|E5|Reported Event|Thiopental 3mcg/mL|"Anesthetic Drug Infusion~Thiopental 3mcg/mL: IV Thiopental 3mcg/mL infusion for 2 hours"
1020483|NCT00767767|E4|Reported Event|Thiopental 1.5mcg/mL|"Anesthetic Drug Infusion~Thiopental 1.5mcg/mL: IV Thiopental 1.5mcg/mL infusion for 2 hours"
1020484|NCT00767767|E3|Reported Event|Propofol 0.90mcg/mL|"Anesthetic Drug Infusion~Propofol 0.90mcg/mL: IV Propofol infusion for 2 hours."
1020485|NCT00767767|E2|Reported Event|Propofol 0.45mcg/mL|"Anesthetic Drug Infusion~Propofol 0.45mcg/mL: IV Propofol infusion for 2 hours."
1020486|NCT00767767|E1|Reported Event|Placebos|"Saline Infusion~Placebos: IV Saline infusion for 2 hours."
1020487|NCT00767676|B1|Baseline|HP828-101|HP828-101 : Nine topical patch applications over 3 weeks, rest period of 2 weeks and challenge after 48 hours.
1020488|NCT00767676|P1|Participant Flow|HP828-101|HP828-101 : Nine topical patch applications, each the approximate size of a nickel, over 3 weeks, rest period of 2 weeks and challenge after 48 hours.
1020489|NCT00767676|O1|Outcome|HP828-101|HP828-101 : Nine topical patch applications over 3 weeks, rest period of 2 weeks and challenge after 48 hours.
1020490|NCT00767676|E1|Reported Event|HP828-101|HP828-101 : Nine topical patch applications over 3 weeks, rest period of 2 weeks and challenge after 48 hours.
1020491|NCT00767624|B3|Baseline|Total|Total of all reporting groups
1020492|NCT00767624|B2|Baseline|Antidepressant + Cognitive Behavioral|"Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Cognitive Behavioral Therapy for Insomnia"
1020493|NCT00767624|B1|Baseline|Antidepressant + Desensitization|"Combined antidepressant medication (determined by an algorithm) plus desensitization therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Desensitization Therapy for Insomnia"
1020494|NCT00767624|P2|Participant Flow|Antidepressant + Cognitive Behavioral|"Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Cognitive Behavioral Therapy for Insomnia"
1020495|NCT00767624|P1|Participant Flow|Antidepressant + Desensitization|"Combined antidepressant medication (determined by an algorithm) plus desensitization therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Desensitization Therapy for Insomnia"
1020496|NCT00767624|O2|Outcome|Antidepressant + Cognitive Behavioral|"Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Cognitive Behavioral Therapy for Insomnia"
1020497|NCT00767624|O1|Outcome|Antidepressant + Desensitization|"Combined antidepressant medication (determined by an algorithm) plus desensitization therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Desensitization Therapy for Insomnia"
1020498|NCT00767624|O2|Outcome|Antidepressant + Cognitive Behavioral|"Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Cognitive Behavioral Therapy for Insomnia"
1020499|NCT00767624|O1|Outcome|Antidepressant + Desensitization|"Combined antidepressant medication (determined by an algorithm) plus desensitization therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Desensitization Therapy for Insomnia"
1020500|NCT00767624|E2|Reported Event|Antidepressant + Cognitive Behavioral|"Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Cognitive Behavioral Therapy for Insomnia"
1020501|NCT00767624|E1|Reported Event|Antidepressant + Desensitization|"Combined antidepressant medication (determined by an algorithm) plus desensitization therapy~Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance~Desensitization Therapy for Insomnia"
1020502|NCT00767572|B1|Baseline|Atorvastatin Then Sugar Pill, or Sugar Pill Then Atorvastatin|Patients were randomly assigned to receive atorvastatin or placebo once daily for 12 weeks. After a 4 week washout, each participant received the other intervention for 12 weeks. Brachial artery assessment were performed before and after each 12 week intervention.
1020503|NCT00767572|P1|Participant Flow|Atorvastatin Then Sugar Pill, or Sugar Pill Then Atorvastatin|Patients were randomized to atorvastatin or placebo once daily for 12 weeks. After a 4 week washout, each participant received the other intervention for 12 weeks. Brachial artery assessment was performed before and after each 12 week intervention.
1020504|NCT00767572|O2|Outcome|Sugar Pill|See above. Patients will be randomized to atorvastatin vs. placebo for 12 weeks and after a 4 week washout period the groups will be switched.
1020505|NCT00767572|O1|Outcome|Atorvastatin|Patients are randomized to either atorvastatin or placebo once daily for 12 weeks. There is a 4 week washout, and then the groups are switched for 12 weeks.
1020506|NCT00767572|E2|Reported Event|Sugar Pill|See above. Patients will be randomized to atorvastatin vs. placebo for 12 weeks and after a 4 week washout period the groups will be switched.
1020507|NCT00767572|E1|Reported Event|Atorvastatin|Patients are randomized to either atorvastatin or placebo once daily for 12 weeks. There is a 4 week washout, and then the groups are switched for 12 weeks. Brachial artery assessment will be performed before and after each 12 week period on therapy.
1020508|NCT00767520|B3|Baseline|Total|Total of all reporting groups
1020509|NCT00767520|B2|Baseline|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
1020510|NCT00767520|B1|Baseline|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
1020511|NCT00767520|P2|Participant Flow|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
1020512|NCT00767520|P1|Participant Flow|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
1020513|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
1020514|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
1020515|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
1020516|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
1020517|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
1020518|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
1020519|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
1020520|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
1020521|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
1020522|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
1020523|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
1020524|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
1020525|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
1020526|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
1020527|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
1020528|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
1020529|NCT00767520|O2|Outcome|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
1020530|NCT00767520|O1|Outcome|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
1020531|NCT00767520|E2|Reported Event|Exemestane + Placebo|Oral dose of exemestane 25 mg + placebo 100 mg, once daily, until disease progression or unacceptable toxicity
1020532|NCT00767520|E1|Reported Event|Exemestane + Dasatinib|Oral dose of exemestane 25 mg + dasatinib 100 mg, once daily, until disease progression or unacceptable toxicity
1020533|NCT00767507|B5|Baseline|Total|Total of all reporting groups
1020534|NCT00767507|B4|Baseline|Stage II Placebo Arm|Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
1020535|NCT00767507|B3|Baseline|Stage II Cangrelor Arm (0.75 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
1020536|NCT00767507|B2|Baseline|Stage I, Cohort II - 0.75 mcg/kg/Min Cangrelor|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
1020537|NCT00767507|B1|Baseline|Stage I, Cohort I - 0.5 mcg/kg/Min Cangrelor|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
1020538|NCT00767507|P4|Participant Flow|Stage II - Placebo Arm|Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
1020539|NCT00767507|P3|Participant Flow|Stage II - Cangrelor Arm (0.75 mcg/kg/Min )|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
1020540|NCT00767507|P2|Participant Flow|Stage I, Cohort II - 0.75 mcg/kg/Min Cangrelor|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
1020541|NCT00767507|P1|Participant Flow|Stage I, Cohort I - 0.5 mcg/kg/Min Cangrelor|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
1020542|NCT00767507|O4|Outcome|Stage I - Cohort II - Cangrelor 0.75 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
1020543|NCT00767507|O3|Outcome|Stage I, Cohort 1 - Cangrelor (0.5 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
1020544|NCT00767507|O2|Outcome|Stage II - Placebo Arm|Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
1020545|NCT00767507|O1|Outcome|Stage II - Cangrelor Arm (0.75 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
1020546|NCT00767507|O4|Outcome|Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
1020547|NCT00767507|O3|Outcome|Stage I, Cohort 1 - Cangrelor 0.5 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
1020548|NCT00767507|O2|Outcome|Stage II - Placebo Arm|Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
1020549|NCT00767507|O1|Outcome|Stage II - Cangrelor (0.75 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
1020550|NCT00767507|O4|Outcome|Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
1020551|NCT00767507|O3|Outcome|Stage I, Cohort I - Cangrelor 0.5 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
1020552|NCT00767507|O2|Outcome|Stage II - Placebo Arm|Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
1020553|NCT00767507|O1|Outcome|Stage II - Cangrelor Arm (0.75 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
1020554|NCT00767507|O2|Outcome|Stage II - Placebo Arm|Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
1020555|NCT00767507|O1|Outcome|Stage II - Cangrelor Arm (0.75 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
1020556|NCT00767507|O2|Outcome|Stage II - Placebo Arm|Patients who received m as a matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
1020557|NCT00767507|O1|Outcome|Stage II - Cangrelor Arm (0.75 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
1020558|NCT00767507|O2|Outcome|Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
1020559|NCT00767507|O1|Outcome|Stage I, Cohort I - Cangrelor 0.5 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
1020650|NCT00767000|B3|Baseline|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
1020560|NCT00767507|E4|Reported Event|Stage II - Placebo Arm|Patients who received matching placebo as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
1020561|NCT00767507|E3|Reported Event|Stage II - Cangrelor Arm (0.75 mcg/kg/Min)|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
1020562|NCT00767507|E2|Reported Event|Stage I, Cohort II - Cangrelor 0.75 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.75 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
1020563|NCT00767507|E1|Reported Event|Stage I, Cohort I - Cangrelor 0.5 mcg/kg/Min|Patients who received cangrelor as a continuous IV infusion of 0.5 mcg/kg/min for a minimum of 48 hours and a maximum of 7 days.
1020564|NCT00767455|B1|Baseline|HP828-101 vs. Negative Control vs. Positive Control|each subject was their own control and received patches of all (test article, negative control, and positive control)
1020565|NCT00767455|P1|Participant Flow|HP828-101 vs. Negative Control vs. Positive Control|Each subject was their own control and received patches containing approximately 200 mg of all three (test article, negative control, and positive control)
1020566|NCT00767455|O3|Outcome|Positive Control|Sodium Lauryl Sulfate
1020567|NCT00767455|O2|Outcome|Negative Control|Johnson's Baby Oil
1020568|NCT00767455|O1|Outcome|HP828-101|Intervention test article
1020569|NCT00767455|E1|Reported Event|HP828-101 vs. Negative Control vs. Positive Control|each subject was their own control and received patches of all (test article, negative control, and positive control)
1020570|NCT00767364|B3|Baseline|Total|Total of all reporting groups
1020571|NCT00767364|B2|Baseline|Healthy Infants|"Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
1020572|NCT00767364|B1|Baseline|Infants With Bowel Resection|"Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
1020573|NCT00767364|P2|Participant Flow|Healthy Infants|"Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
1020574|NCT00767364|P1|Participant Flow|Infants With Bowel Resection|"Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
1020575|NCT00767364|O2|Outcome|Healthy Infants|"Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
1020576|NCT00767364|O1|Outcome|Infants With Bowel Resection|"Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
1020577|NCT00767364|O2|Outcome|Healthy Infants|"Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
1020578|NCT00767364|O1|Outcome|Infants With Bowel Resection|"Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
1020579|NCT00767364|E2|Reported Event|Healthy Infants|"Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
1020580|NCT00767364|E1|Reported Event|Infants With Bowel Resection|"Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).~Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series"
1020581|NCT00767338|B5|Baseline|Total|Total of all reporting groups
1020582|NCT00767338|B4|Baseline|Surgery + TI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
1020583|NCT00767338|B3|Baseline|Surgery + IUI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
1020584|NCT00767338|B2|Baseline|No Surgery + TI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
1020585|NCT00767338|B1|Baseline|No Surgery + IUI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
1020586|NCT00767338|P4|Participant Flow|Surgery + TI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
1020587|NCT00767338|P3|Participant Flow|Surgery + IUI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
1020588|NCT00767338|P2|Participant Flow|No Surgery + TI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
1020589|NCT00767338|P1|Participant Flow|No Surgery + IUI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
1020590|NCT00767338|O4|Outcome|Surgery + TI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
1020591|NCT00767338|O3|Outcome|Surgery + IUI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
1020592|NCT00767338|O2|Outcome|No Surgery + TI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
1020831|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
1020593|NCT00767338|O1|Outcome|No Surgery + IUI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
1020594|NCT00767338|E4|Reported Event|Surgery + TI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
1020595|NCT00767338|E3|Reported Event|Surgery + IUI|Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
1020596|NCT00767338|E2|Reported Event|No Surgery + TI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
1020597|NCT00767338|E1|Reported Event|No Surgery + IUI|No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
1020598|NCT00767325|B1|Baseline|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
1020599|NCT00767325|P1|Participant Flow|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
1020600|NCT00767325|O1|Outcome|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
1020601|NCT00767325|O1|Outcome|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
1020602|NCT00767325|O1|Outcome|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
1020603|NCT00767325|O1|Outcome|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
1020604|NCT00767325|O1|Outcome|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
1020605|NCT00767325|O1|Outcome|Abatacept, 10 mg/kg|All participants received abatacept by intravenous infusion at a fixed-dose approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, and 169 in addition to oral methotrexate. Abatacept dose was based on body weight at screening.
1020606|NCT00767325|E1|Reported Event|Aba 10 mg/kg|
1020607|NCT00767104|B3|Baseline|Total|Total of all reporting groups
1020608|NCT00767104|B2|Baseline|Control Pillowcase|placebo pillowcase made of 100% cotton
1020609|NCT00767104|B1|Baseline|DermaTherapy Pillowcases|The study pillowcases are fabricated from a light-weight plain-weave fabric woven of 100 percent synthetic yarns. The fabric is comprised of approximately 50% polyester and 50% nylon. The yarns in the fabric are formed from continuous-filament fibers, with no fibers projecting beyond the planar surface of the fabric. The antimicrobial technology used in the fabric is incorporated into the fibers during the finishing process and does not migrate out of the fabric or cause adverse reactions with skin contact.
1020610|NCT00767104|P2|Participant Flow|Control Pillowcase|placebo pillowcase made of 100% cotton
1020611|NCT00767104|P1|Participant Flow|DermaTherapy Pillowcases|The study pillowcases are fabricated from a light-weight plain-weave fabric woven of 100 percent synthetic yarns. The fabric is comprised of approximately 50% polyester and 50% nylon. The yarns in the fabric are formed from continuous-filament fibers, with no fibers projecting beyond the planar surface of the fabric. The antimicrobial technology used in the fabric is incorporated into the fibers during the finishing process and does not migrate out of the fabric or cause adverse reactions with skin contact.
1020612|NCT00767104|O2|Outcome|Control Pillowcase|placebo pillowcase made of 100% cotton
1020613|NCT00767104|O1|Outcome|DermaTherapy Pillowcases|The study pillowcases are fabricated from a light-weight plain-weave fabric woven of 100 percent synthetic yarns. The fabric is comprised of approximately 50% polyester and 50% nylon. The yarns in the fabric are formed from continuous-filament fibers, with no fibers projecting beyond the planar surface of the fabric. The antimicrobial technology used in the fabric is incorporated into the fibers during the finishing process and does not migrate out of the fabric or cause adverse reactions with skin contact.
1020614|NCT00767104|O2|Outcome|Control Cotton Pillowcase|placebo pillowcase made of 100% cotton
1020615|NCT00767104|O1|Outcome|Experimental Silk-like Pillowcases|The study pillowcases are fabricated from a light-weight plain-weave fabric woven of 100 percent synthetic yarns. The fabric is comprised of approximately 50% polyester and 50% nylon. The yarns in the fabric are formed from continuous-filament fibers, with no fibers projecting beyond the planar surface of the fabric. The antimicrobial technology used in the fabric is incorporated into the fibers during the finishing process and does not migrate out of the fabric or cause adverse reactions with skin contact.
1020616|NCT00767104|E2|Reported Event|Control Pillowcase|placebo pillowcase made of 100% cotton
1020617|NCT00767104|E1|Reported Event|DermaTherapy Pillowcases|The study pillowcases are fabricated from a light-weight plain-weave fabric woven of 100 percent synthetic yarns. The fabric is comprised of approximately 50% polyester and 50% nylon. The yarns in the fabric are formed from continuous-filament fibers, with no fibers projecting beyond the planar surface of the fabric. The antimicrobial technology used in the fabric is incorporated into the fibers during the finishing process and does not migrate out of the fabric or cause adverse reactions with skin contact.
1020618|NCT00767039|B3|Baseline|Total|Total of all reporting groups
1020619|NCT00767039|B2|Baseline|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
1020651|NCT00767000|B2|Baseline|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
1020620|NCT00767039|B1|Baseline|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
1020621|NCT00767039|P2|Participant Flow|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
1020622|NCT00767039|P1|Participant Flow|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
1020623|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
1020624|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
1020625|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
1020626|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
1020627|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
1020628|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
1020629|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
1020630|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
1020631|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
1020632|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
1020633|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
1020634|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
1020635|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
1020636|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
1020637|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
1020638|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
1020639|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
1020640|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
1020641|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
1020642|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
1020643|NCT00767039|O2|Outcome|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
1020644|NCT00767039|O1|Outcome|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
1020645|NCT00767039|E2|Reported Event|Poractant Alfa Arm|Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
1020646|NCT00767039|E1|Reported Event|Beractant Arm|Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)
1020647|NCT00767000|B6|Baseline|Total|Total of all reporting groups
1020648|NCT00767000|B5|Baseline|Placebo|Placebo three times daily plus insulin once daily with or without metformin
1020649|NCT00767000|B4|Baseline|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
1020652|NCT00767000|B1|Baseline|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
1020653|NCT00767000|P5|Participant Flow|Placebo|Placebo three times daily plus insulin once daily with or without metformin
1020654|NCT00767000|P4|Participant Flow|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
1020655|NCT00767000|P3|Participant Flow|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
1020656|NCT00767000|P2|Participant Flow|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
1020657|NCT00767000|P1|Participant Flow|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
1020658|NCT00767000|O5|Outcome|Placebo|Placebo three times daily plus insulin once daily with or without metformin
1020659|NCT00767000|O4|Outcome|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
1020660|NCT00767000|O3|Outcome|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
1020661|NCT00767000|O2|Outcome|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
1020662|NCT00767000|O1|Outcome|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
1020663|NCT00767000|O5|Outcome|Placebo|Placebo three times daily plus insulin once daily with or without metformin
1020664|NCT00767000|O4|Outcome|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
1020665|NCT00767000|O3|Outcome|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
1020666|NCT00767000|O2|Outcome|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
1020667|NCT00767000|O1|Outcome|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
1020668|NCT00767000|O5|Outcome|Placebo|Placebo three times daily plus insulin once daily with or without metformin
1020669|NCT00767000|O4|Outcome|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
1020670|NCT00767000|O3|Outcome|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
1020671|NCT00767000|O2|Outcome|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
1020672|NCT00767000|O1|Outcome|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
1020673|NCT00767000|O5|Outcome|Placebo|Placebo three times daily plus insulin once daily with or without metformin
1020674|NCT00767000|O4|Outcome|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
1020675|NCT00767000|O3|Outcome|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
1020676|NCT00767000|O2|Outcome|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
1020677|NCT00767000|O1|Outcome|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
1020678|NCT00767000|O5|Outcome|Placebo|Placebo three times daily plus insulin once daily with or without metformin
1020679|NCT00767000|O4|Outcome|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
1020680|NCT00767000|O3|Outcome|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
1020681|NCT00767000|O2|Outcome|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
1020682|NCT00767000|O1|Outcome|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
1020683|NCT00767000|O5|Outcome|Placebo|Placebo three times daily plus insulin once daily with or without metformin
1020684|NCT00767000|O4|Outcome|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
1020685|NCT00767000|O3|Outcome|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
1020686|NCT00767000|O2|Outcome|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
1020687|NCT00767000|O1|Outcome|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
1020688|NCT00767000|O5|Outcome|Placebo|Placebo three times daily plus insulin once daily with or without metformin
1020689|NCT00767000|O4|Outcome|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
1020690|NCT00767000|O3|Outcome|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
1020691|NCT00767000|O2|Outcome|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
1020692|NCT00767000|O1|Outcome|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
1020693|NCT00767000|E5|Reported Event|Placebo|Placebo three times daily plus insulin once daily with or without metformin
1020694|NCT00767000|E4|Reported Event|MK-0941 40 mg|MK-0941 40 mg three times daily plus insulin once daily with or without metformin
1020695|NCT00767000|E3|Reported Event|MK-0941 30 mg|MK-0941 30 mg three times daily plus insulin once daily with or without metformin
1020696|NCT00767000|E2|Reported Event|MK-0941 20 mg|MK-0941 20 mg three times daily plus insulin once daily with or without metformin
1020697|NCT00767000|E1|Reported Event|MK-0941 10 mg|MK-0941 10 mg three times daily plus insulin once daily with or without metformin
1020698|NCT00766831|B1|Baseline|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
1020699|NCT00766831|P1|Participant Flow|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
1020700|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
1020701|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
1020702|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
1020703|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
1020704|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
1020705|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
1020706|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
1020707|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
1020708|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
1020709|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
1020710|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
1020711|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
1020712|NCT00766831|O1|Outcome|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
1020713|NCT00766831|E1|Reported Event|Hydromorphone OROS|Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator’s discretion for additional 84 days of extension phase.
1020714|NCT00766753|B3|Baseline|Total|Total of all reporting groups
1020715|NCT00766753|B2|Baseline|AlphaDC1 - Dose Level 2 (3 x 10 7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
1020716|NCT00766753|B1|Baseline|AlphaDC1 - Dose Level 1(1 X 10 7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
1020832|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
1020717|NCT00766753|P2|Participant Flow|AlphaDC1 - Dose Level 2 (3 x 10 7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
1020718|NCT00766753|P1|Participant Flow|AlphaDC1 - Dose Level 1(1 X 10 7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
1020719|NCT00766753|O2|Outcome|AlphaDC1 - Dose Level 2 (3 x 10^7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
1020720|NCT00766753|O1|Outcome|AlphaDC1 - Dose Level 1(1 X 10^7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
1020721|NCT00766753|O2|Outcome|AlphaDC1 - Dose Level 2 (3 x 10 7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
1020722|NCT00766753|O1|Outcome|AlphaDC1 - Dose Level 1(1 X 10 7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
1020723|NCT00766753|O2|Outcome|AlphaDC1 - Dose Level 2 (3 x 10 7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
1020724|NCT00766753|O1|Outcome|AlphaDC1 - Dose Level 1(1 X 10 7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
1020725|NCT00766753|O2|Outcome|AlphaDC1 - Dose Level 2 (3 x 10^7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
1020726|NCT00766753|O1|Outcome|AlphaDC1 - Dose Level 1(1 X 10^7) + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC)
1020727|NCT00766753|E1|Reported Event|Alpha DC1 Vaccine + Poly-ICLC|Patients with recurrent malignant glioma treated with novel vaccination with -type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC) who received at least one vaccine, up to 4 vaccines
1020728|NCT00766675|B1|Baseline|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
1020729|NCT00766675|P1|Participant Flow|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
1020730|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
1020731|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
1020732|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
1020733|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
1020734|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
1020735|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
1020736|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
1020737|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
1020738|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
1020739|NCT00766675|O1|Outcome|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
1020740|NCT00766675|E1|Reported Event|Tramadol Hydrochloride/Acetaminophen|Tramadol hydrochloride/acetaminophen oral tablet was administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
1020741|NCT00766649|B1|Baseline|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
1020742|NCT00766649|P1|Participant Flow|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
1020743|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
1020744|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
1020745|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
1020746|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
1020747|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
1020748|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
1020749|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
1020750|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
1020751|NCT00766649|O1|Outcome|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
1020752|NCT00766649|E1|Reported Event|Sirolimus|Participants receive a 20 μL (440 μg) subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter.
1020753|NCT00766636|B3|Baseline|Total|Total of all reporting groups
1020754|NCT00766636|B2|Baseline|Gemcitabine + Erlotinib With Radiation|Gemcitabine + Erlotinib with radiation - Arm B: Gemcitabine 400 mg/M^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Radiation therapy 1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy. Surgical removal of the pancreas and duodenum.
1020755|NCT00766636|B1|Baseline|Gemcitabine + Erlotinib Without Radiation|"Gemcitabine + Erlotinib without radiation - Arm A: Gemcitabine 1000 mg/M^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42.~Surgical removal of the pancreas and duodenum."
1020756|NCT00766636|P2|Participant Flow|Gemcitabine + Erlotinib With Radiation|Gemcitabine + Erlotinib with radiation - Arm B: Gemcitabine 400 mg/M^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Radiation therapy 1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy. Surgical removal of the pancreas and duodenum.
1020757|NCT00766636|P1|Participant Flow|Gemcitabine + Erlotinib Without Radiation|"Gemcitabine + Erlotinib without radiation - Arm A: Gemcitabine 1000 mg/M^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42.~Surgical removal of the pancreas and duodenum."
1020758|NCT00766636|O2|Outcome|Gemcitabine + Erlotinib With Radiation|Gemcitabine + Erlotinib with radiation - Arm B: Gemcitabine 400 mg/M^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Radiation therapy 1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy. Surgical removal of the pancreas and duodenum.
1020759|NCT00766636|O1|Outcome|Gemcitabine + Erlotinib Without Radiation|"Gemcitabine + Erlotinib without radiation - Arm A: Gemcitabine 1000 mg/M^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42.~Surgical removal of the pancreas and duodenum."
1020760|NCT00766636|E2|Reported Event|Gemcitabine + Erlotinib With Radiation|Gemcitabine + Erlotinib with radiation - Arm B: Gemcitabine 400 mg/M^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Radiation therapy 1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy. Surgical removal of the pancreas and duodenum.
1020761|NCT00766636|E1|Reported Event|Gemcitabine + Erlotinib Without Radiation|"Gemcitabine + Erlotinib without radiation - Arm A: Gemcitabine 1000 mg/M^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42.~Surgical removal of the pancreas and duodenum."
1020762|NCT00766597|B1|Baseline|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
1020763|NCT00766597|P1|Participant Flow|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
1020764|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
1020789|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
1020765|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
1020766|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
1020767|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
1020768|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1 mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
1020769|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
1020770|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
1020771|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1mg/ml)|"HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic Virus~Vicriviroc: Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen"
1020772|NCT00766597|O1|Outcome|Vicriviroc in Tablet Form (20/30 mg) or Liquid Form (1mg/ml)|HIV-1 Infected Antiretroviral Therapy Experienced Participants with CCR5-tropic virus
1020773|NCT00766597|E1|Reported Event|Vicriviroc in Tablet Form (20/30mg) or Liquid Form (1mg/ml)|Drug: Vicriviroc Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen
1020774|NCT00766532|B1|Baseline|Group 1|
1020775|NCT00766532|P1|Participant Flow|Arm Title- Aromatase Inhibitor Therapy|calcium absorption was measured among subjects at baseline and after taking aromatase inhibitor therapy.
1020776|NCT00766532|O1|Outcome|Aromatase Inhibitor Therapy|
1020777|NCT00766532|E1|Reported Event|Group 1|
1020778|NCT00766506|B3|Baseline|Total|Total of all reporting groups
1020779|NCT00766506|B2|Baseline|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
1020780|NCT00766506|B1|Baseline|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
1020781|NCT00766506|P2|Participant Flow|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
1020782|NCT00766506|P1|Participant Flow|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS [a device which uses an electric current to move drug through the skin into the blood]), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
1020783|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
1020784|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
1020785|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
1020786|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
1020787|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
1020788|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
1020824|NCT00766467|E2|Reported Event|Placebo|Placebo: Taken orally once a day in the morning.
1020825|NCT00766467|E1|Reported Event|Armodafinil|Armodafinil: Taken orally once a day in the morning.
1020790|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
1020791|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
1020792|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
1020793|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
1020794|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
1020795|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
1020796|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
1020797|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
1020798|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
1020799|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
1020800|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
1020801|NCT00766506|O2|Outcome|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
1020802|NCT00766506|O1|Outcome|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
1020803|NCT00766506|E2|Reported Event|Morphine IV PCA|Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician’s discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours.
1020804|NCT00766506|E1|Reported Event|Fentanyl IONSYS|Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours.
1020805|NCT00766493|B1|Baseline|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
1020806|NCT00766493|P1|Participant Flow|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
1020807|NCT00766493|O1|Outcome|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
1020808|NCT00766493|O1|Outcome|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
1020809|NCT00766493|O1|Outcome|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
1020810|NCT00766493|O1|Outcome|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
1020811|NCT00766493|O1|Outcome|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
1020812|NCT00766493|E1|Reported Event|EMBOLDEN|GORE® Embolic Filter with carotid artery stenting
1020813|NCT00766467|B3|Baseline|Total|Total of all reporting groups
1020814|NCT00766467|B2|Baseline|Placebo|Placebo: Taken orally once a day in the morning.
1020815|NCT00766467|B1|Baseline|Armodafinil|Armodafinil: Taken orally once a day in the morning.
1020816|NCT00766467|P2|Participant Flow|Placebo|Placebo: Taken orally once a day in the morning
1020817|NCT00766467|P1|Participant Flow|Armodafinil|Armodafinil: 150mg taken orally once a day in the morning.
1020818|NCT00766467|O2|Outcome|Placebo|Placebo: Taken orally once a day in the morning.
1020819|NCT00766467|O1|Outcome|Armodafinil|Armodafinil: Taken orally once a day in the morning.
1020820|NCT00766467|O2|Outcome|Placebo|Placebo: Taken orally once a day in the morning.
1020821|NCT00766467|O1|Outcome|Armodafinil|Armodafinil: Taken orally once a day in the morning.
1020822|NCT00766467|O2|Outcome|Placebo|Placebo: Taken orally once a day in the morning.
1020823|NCT00766467|O1|Outcome|Armodafinil|Armodafinil: Taken orally once a day in the morning.
1020877|NCT00766376|B1|Baseline|Erbium Laser|Each subject will undergo a minimum of 1 treatment with 5 scheduled follow-up visits. Additional follow-up visits may be required to accommodate optional biopsies or to evaluate any concerns related to the course of healing. At each visit, the treated areas will be clinically evaluated and photographed.
1020878|NCT00766376|P1|Participant Flow|Erbium Laser|Each Subject will undergo 1 - 6 treatment sessions, with 5 scheduled time-points for follow-up visits. Additional follow-up visits may be required to accommodate optional biopsies or to evaluate any concerns related to the course of healing. At each visit, the treated areas will be clinically evaluated and photographed.
1020879|NCT00766376|O1|Outcome|Erbium Laser|Each Subject will undergo 1 - 6 treatment sessions, with 5 scheduled time-points for follow-up visits. Additional follow-up visits may be required to accommodate optional biopsies or to evaluate any concerns related to the course of healing. At each visit, the treated areas will be clinically evaluated and photographed.
1020880|NCT00766376|O1|Outcome|Erbium Laser|Each Subject will undergo 1 - 6 treatment sessions, with 5 scheduled time-points for follow-up visits. Additional follow-up visits may be required to accommodate optional biopsies or to evaluate any concerns related to the course of healing. At each visit, the treated areas will be clinically evaluated and photographed.
1020881|NCT00766376|E1|Reported Event|Erbium Laser|Each Subject will undergo 1 - 6 treatment sessions, with 5 scheduled time-points for follow-up visits. Additional follow-up visits may be required to accommodate optional biopsies or to evaluate any concerns related to the course of healing. At each visit, the treated areas will be clinically evaluated and photographed.
1020882|NCT00766363|B5|Baseline|Total|Total of all reporting groups
1020883|NCT00766363|B4|Baseline|Placebo|1 capsule per day for 28 days.
1020884|NCT00766363|B3|Baseline|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
1020885|NCT00766363|B2|Baseline|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
1020886|NCT00766363|B1|Baseline|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
1020887|NCT00766363|P4|Participant Flow|Placebo|1 capsule per day for 28 days.
1020888|NCT00766363|P3|Participant Flow|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
1020889|NCT00766363|P2|Participant Flow|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
1020890|NCT00766363|P1|Participant Flow|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
1020891|NCT00766363|O2|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
1020892|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
1020893|NCT00766363|O2|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
1020894|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
1020895|NCT00766363|O2|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
1020896|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
1020897|NCT00766363|O4|Outcome|Placebo|1 capsule per day for 28 days.
1020898|NCT00766363|O3|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
1020899|NCT00766363|O2|Outcome|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
1020900|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
1020901|NCT00766363|O4|Outcome|Placebo|1 capsule per day for 28 days.
1020902|NCT00766363|O3|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
1020903|NCT00766363|O2|Outcome|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
1020904|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
1020905|NCT00766363|O4|Outcome|Placebo|1 capsule per day for 28 days.
1020906|NCT00766363|O3|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
1020907|NCT00766363|O2|Outcome|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
1020908|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
1020909|NCT00766363|O3|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
1020910|NCT00766363|O2|Outcome|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
1020911|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
1020912|NCT00766363|O3|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
1020913|NCT00766363|O2|Outcome|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
1020914|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
1020915|NCT00766363|O3|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
1020916|NCT00766363|O2|Outcome|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
1020917|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
1020918|NCT00766363|O4|Outcome|Placebo|1 capsule per day for 28 days.
1020919|NCT00766363|O3|Outcome|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
1020920|NCT00766363|O2|Outcome|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
1020921|NCT00766363|O1|Outcome|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
1020922|NCT00766363|E4|Reported Event|Placebo|1 capsule per day for 28 days.
1020923|NCT00766363|E3|Reported Event|EVP-6124 (1.0 mg/Day)|1 capsule per day for 28 days.
1020924|NCT00766363|E2|Reported Event|EVP-6124 (0.3 mg/Day)|1 capsule per day for 28 days.
1020925|NCT00766363|E1|Reported Event|EVP-6124 (0.1 mg/Day)|1 capsule per day for 28 days.
1020926|NCT00766090|B3|Baseline|Total|Total of all reporting groups
1020927|NCT00766090|B2|Baseline|FP 200 µg, FP 100 µg, and Placebo Via DISKUS|Participants received FP 200 µg inhalation powder OD in the evening, FP 100 µg inhalation powder BID, and placebo BID in one of the three treatment periods. All treatments were administered via a DISKUS for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020928|NCT00766090|B1|Baseline|FF 200 µg, FF 100 µg, and Placebo Via DPI|Participants received FF 200 µg inhalation powder OD in the evening, FF 100 µg inhalation powder BID, and placebo BID in one of the three treatment periods. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1021014|NCT00765882|P2|Participant Flow|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
1020929|NCT00766090|P12|Participant Flow|Sequence 12: FP 200 µg, FP 100 µg, Placebo|Participants received FP 200 µg inhalation powder OD in the evening, FP 100 µg inhalation powder BID, and placebo BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020930|NCT00766090|P11|Participant Flow|Sequence 11: FP 200 µg, Placebo, FP 100 µg|Participants received FP 200 µg inhalation powder OD in the evening, placebo BID, and FP 100 µg inhalation powder BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020931|NCT00766090|P10|Participant Flow|Sequence 10: FP 100 µg, FP 200 µg, Placebo|Participants received FP 100 µg inhalation powder BID, FP 200 µg inhalation powder OD in the evening, and placebo BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020932|NCT00766090|P9|Participant Flow|Sequence 9: FP 100 µg, Placebo, FP 200 µg|Participants received FP 100 µg inhalation powder BID, placebo BID, and FP 200 µg inhalation powder OD in the evening in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020933|NCT00766090|P8|Participant Flow|Sequence 8: Placebo, FP 100 µg, FP 200 µg|Participants received placebo BID, FP 100 µg inhalation powder BID, and FP 200 µg inhalation powder OD in the evening in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020934|NCT00766090|P7|Participant Flow|Sequence 7: Placebo, FP 200 µg, FP 100 µg|Participants received placebo twice daily (BID), fluticasone propionate (FP) 200 microgram (µg) inhalation powder once daily (OD) in the evening, and FP 100 µg inhalation powder twice daily (BID) in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020935|NCT00766090|P6|Participant Flow|Sequence 6: FF 200 µg, FF 100 µg, Placebo|Participants received FF 200 µg inhalation powder OD in the evening, FF 100 µg inhalation powder BID, and placebo BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020936|NCT00766090|P5|Participant Flow|Sequence 5: FF 200 µg, Placebo, FF 100 µg|Participants received FF 200 µg inhalation powder OD in the evening, placebo BID, and FF 100 µg inhalation powder BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020937|NCT00766090|P4|Participant Flow|Sequence 4: FF 100 µg, FF 200 µg, Placebo|Participants received FF 100 µg inhalation powder BID, FF 200 µg inhalation powder OD in the evening, and placebo BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020938|NCT00766090|P3|Participant Flow|Sequence 3: FF 100 µg, Placebo, FF 200 µg|Participants received FF 100 µg inhalation powder BID, placebo BID, and FF 200 µg inhalation powder OD in the evening in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020939|NCT00766090|P2|Participant Flow|Sequence 2: Placebo, FF 100 µg, FF 200 µg|Participants received placebo BID, FF 100 µg inhalation powder BID, and FF 200 µg inhalation powder OD in the evening in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020940|NCT00766090|P1|Participant Flow|Sequence 1: Placebo, FF 200 µg, FF 100 µg|Participants received placebo twice daily (BID), fluticasone furoate (FF) 200 microgram (µg) inhalation powder once daily (OD) in the evening, and FF 100 µg inhalation powder twice daily (BID) in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020941|NCT00766090|O2|Outcome|FP 200 µg, FP 100 µg, and Placebo Via DISKUS|Participants received FP 200 µg inhalation powder OD in the evening, FP 100 µg inhalation powder BID, and placebo BID in one of the three treatment periods. All treatments were administered via a DISKUS for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020942|NCT00766090|O1|Outcome|FF 200 µg, FF 100 µg, and Placebo Via DPI|Participants received FF 200 µg inhalation powder OD in the evening, FF 100 µg inhalation powder BID, and placebo BID in one of the three treatment periods. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1021015|NCT00765882|P1|Participant Flow|Placebo|Dose matched placebo, oral administration, once per day.
1020943|NCT00766090|O5|Outcome|FP 100 µg BID|Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020944|NCT00766090|O4|Outcome|FP 200 µg OD|Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020945|NCT00766090|O3|Outcome|FF 100 µg BID|Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020946|NCT00766090|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020947|NCT00766090|O1|Outcome|Placebo|Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020948|NCT00766090|O5|Outcome|FP 100 µg BID|Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020949|NCT00766090|O4|Outcome|FP 200 µg OD|Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020950|NCT00766090|O3|Outcome|FF 100 µg BID|Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020951|NCT00766090|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020952|NCT00766090|O1|Outcome|Placebo|Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020953|NCT00766090|O5|Outcome|FP 100 µg BID|Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020954|NCT00766090|O4|Outcome|FP 200 µg OD|Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020955|NCT00766090|O3|Outcome|FF 100 µg BID|Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020956|NCT00766090|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020957|NCT00766090|O1|Outcome|Placebo|Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020958|NCT00766090|O5|Outcome|FP 100 µg BID|Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020959|NCT00766090|O4|Outcome|FP 200 µg OD|Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020960|NCT00766090|O3|Outcome|FF 100 µg BID|Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020961|NCT00766090|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020962|NCT00766090|O1|Outcome|Placebo|Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1021179|NCT00765570|O2|Outcome|Treatment Group-2|Treatment Group 2: 15 treatments with standard radiation
1020963|NCT00766090|O5|Outcome|FP 100 µg BID|Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020964|NCT00766090|O4|Outcome|FP 200 µg OD|Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020965|NCT00766090|O3|Outcome|FF 100 µg BID|Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020966|NCT00766090|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020967|NCT00766090|O1|Outcome|Placebo|Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020968|NCT00766090|O5|Outcome|FP 100 µg BID|Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020969|NCT00766090|O4|Outcome|FP 200 µg OD|Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020970|NCT00766090|O3|Outcome|FF 100 µg BID|Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020971|NCT00766090|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020972|NCT00766090|O1|Outcome|Placebo|Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020973|NCT00766090|E5|Reported Event|FP 100 µg BID|Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020974|NCT00766090|E4|Reported Event|FP 200 µg OD|Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020975|NCT00766090|E3|Reported Event|FF 100 µg BID|Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020976|NCT00766090|E2|Reported Event|FF 200 µg OD|Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020977|NCT00766090|E1|Reported Event|Placebo|Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
1020978|NCT00766051|B3|Baseline|Total|Total of all reporting groups
1020979|NCT00766051|B2|Baseline|Intervention Group|This is the only Matched Historical Comparison group infants that the analysis refer to. The intervention group consisted of four Preterm infants with high risk factors, three term or near term infants with Gastroschisis, two near term infants with Omphalocele, and one near term infant with Congenital Diaphragmatic Hernia.
1020980|NCT00766051|B1|Baseline|Matched Historical Comparison Group|This is the only Matched Historical Comparison group infants that the analysis refer to. These infants were drawn from hospital records from a three year period from the time that the study commenced and from the same NCCU. The infants were matched on 19 items modified from Littman and Parmelee (1978) and consisted of four Preterm infants with high risk factors, three term or near term infants with Gastroschisis, two near term infants with Omphalocele, and one near term infant with Congenital Diaphragmatic Hernia.
1020981|NCT00766051|P2|Participant Flow|Matched Historical Comparison Group|Matched Historical Controls drawn from a three year period.
1020982|NCT00766051|P1|Participant Flow|Intervention Group|This is the only intervention group that the analysis apply to.
1020983|NCT00766051|O2|Outcome|Intervention Group Post Test|This is the only intervention group that the analysis apply to.
1020984|NCT00766051|O1|Outcome|Intervention Group Pre-test|This is the only intervention group that the analysis apply to and consisted of preterm, near term and full term infants with feeding problems.
1020985|NCT00766051|O2|Outcome|Intervention Group Post Test|This is the only intervention group that the analysis apply to.
1021016|NCT00765882|O3|Outcome|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
1020986|NCT00766051|O1|Outcome|Intervention Group Pre-test|This is the only intervention group that the analysis apply to and consisted of preterm, near term and full term infants with feeding problems.
1020987|NCT00766051|O1|Outcome|Intervention Group|This is the only intervention group that the analysis apply to and consisted of preterm, near term and full term infants with feeding problems.
1020988|NCT00766051|O2|Outcome|Matched Historical Comparison Group|This is the only Matched Historical Comparison group infants that the analysis refer to. These infants were drawn from hospital records from a three year period from the time that the study commenced and from the same NCCU. The infants were matched on 19 items modified from Littman and Parmelee, (1978).
1020989|NCT00766051|O1|Outcome|Intervention Group|This is the only intervention group that the analysis apply to. The intervention and the matched historical comparison group consisted of preterm, near term and full term infants with feeding problems.
1020990|NCT00766051|E1|Reported Event|Intervention Group|This is the only intervention group that the analysis apply to.
1020991|NCT00765947|B1|Baseline|Aliskiren-based Regimen|Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.
1020992|NCT00765947|P1|Participant Flow|Aliskiren-based Regimen|Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.
1020993|NCT00765947|O1|Outcome|Aliskiren-based Regimen|Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.
1020994|NCT00765947|O1|Outcome|Aliskiren-based Regimen|Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.
1020995|NCT00765947|O1|Outcome|Aliskiren-based Regimen|Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.
1020996|NCT00765947|O1|Outcome|Aliskiren-based Regimen|Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.
1020997|NCT00765947|E3|Reported Event|Aliskiren + HCTZ + Amlodipine|Aliskiren + HCTZ + Amlodipine treatment step
1020998|NCT00765947|E2|Reported Event|Aliskiren + HCTZ|Aliskiren and HCTZ treatment step
1020999|NCT00765947|E1|Reported Event|Aliskiren|Aliskiren treatment step
1021000|NCT00765895|B3|Baseline|Total|Total of all reporting groups
1021001|NCT00765895|B2|Baseline|Placebo|"No treatment~Nortriptyline-Placebo: Nortriptyline-placebo, 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks; f06 visit, 50 mg, two capsules, po qhs x 3 weeks; f09 visit, 75 mg, three capsules, po qhs x 6 weeks, po qhs x 15 wks f15 visit: taper study drug by one capsule a week, off study drug for the last week"
1021002|NCT00765895|B1|Baseline|Nortriptyline|"Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg~Nortriptyline Hydrochloride: Nortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week"
1021003|NCT00765895|P2|Participant Flow|Placebo|"No treatment~Nortriptyline-Placebo: Nortriptyline-placebo, 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks; f06 visit, 50 mg, two capsules, po qhs x 3 weeks; f09 visit, 75 mg, three capsules, po qhs x 6 weeks, po qhs x 15 wks f15 visit: taper study drug by one capsule a week, off study drug for the last week"
1021004|NCT00765895|P1|Participant Flow|Nortriptyline|"Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg~Nortriptyline Hydrochloride: Nortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week"
1021005|NCT00765895|O2|Outcome|Placebo|"No treatment~Nortriptyline-Placebo: Nortriptyline-placebo, 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks; f06 visit, 50 mg, two capsules, po qhs x 3 weeks; f09 visit, 75 mg, three capsules, po qhs x 6 weeks, po qhs x 15 wks f15 visit: taper study drug by one capsule a week, off study drug for the last week"
1021006|NCT00765895|O1|Outcome|Nortriptyline|"Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg~Nortriptyline Hydrochloride: Nortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week"
1021007|NCT00765895|E2|Reported Event|Placebo|"No treatment~Nortriptyline-Placebo: Nortriptyline-placebo, 10 mg, one capsule, po qhs x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks; f06 visit, 50 mg, two capsules, po qhs x 3 weeks; f09 visit, 75 mg, three capsules, po qhs x 6 weeks, po qhs x 15 wks f15 visit: taper study drug by one capsule a week, off study drug for the last week"
1021008|NCT00765895|E1|Reported Event|Nortriptyline|"Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg~Nortriptyline Hydrochloride: Nortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week"
1021009|NCT00765882|B4|Baseline|Total|Total of all reporting groups
1021010|NCT00765882|B3|Baseline|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
1021011|NCT00765882|B2|Baseline|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
1021012|NCT00765882|B1|Baseline|Placebo|Dose matched placebo, oral administration, once per day.
1021013|NCT00765882|P3|Participant Flow|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
1021017|NCT00765882|O2|Outcome|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
1021018|NCT00765882|O1|Outcome|Placebo|Dose matched placebo, oral administration, once per day.
1021019|NCT00765882|O3|Outcome|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
1021020|NCT00765882|O2|Outcome|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
1021021|NCT00765882|O1|Outcome|Placebo|Dose matched placebo, oral administration, once per day.
1021022|NCT00765882|O3|Outcome|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
1021023|NCT00765882|O2|Outcome|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
1021024|NCT00765882|O1|Outcome|Placebo|Dose matched placebo, oral administration, once per day.
1021025|NCT00765882|O3|Outcome|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
1021026|NCT00765882|O2|Outcome|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
1021027|NCT00765882|O1|Outcome|Placebo|Dose matched placebo, oral administration, once per day.
1021028|NCT00765882|O3|Outcome|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
1021029|NCT00765882|O2|Outcome|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
1021030|NCT00765882|O1|Outcome|Placebo|Dose matched placebo, oral administration, once per day.
1021031|NCT00765882|O3|Outcome|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
1021032|NCT00765882|O2|Outcome|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
1021033|NCT00765882|O1|Outcome|Placebo|Dose matched placebo, oral administration, once per day.
1021034|NCT00765882|O3|Outcome|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
1021035|NCT00765882|O2|Outcome|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
1021036|NCT00765882|O1|Outcome|Placebo|Dose matched placebo, oral administration, once per day.
1021037|NCT00765882|O3|Outcome|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
1021038|NCT00765882|O2|Outcome|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
1021039|NCT00765882|O1|Outcome|Placebo|Dose matched placebo, oral administration, once per day.
1021040|NCT00765882|E3|Reported Event|Linaclotide 290µg|Linaclotide, 290µg dose, oral administration, once per day
1021041|NCT00765882|E2|Reported Event|Linaclotide 145µg|Linaclotide, 145µg dose, oral administration, once per day
1021042|NCT00765882|E1|Reported Event|Placebo|Dose matched placebo, oral administration, once per day.
1021043|NCT00765843|B4|Baseline|Total|Total of all reporting groups
1021044|NCT00765843|B3|Baseline|Sham Insoles|"Subjects will receive sham orthoses that are soft and pliable, but not designed to relieve pain. These orthoses are to be used in the standardized shoes provided to all subjects in the study.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
1021045|NCT00765843|B2|Baseline|Pre-fabricated Orthoses|"Subjects will be provided pre-fabricated (non-customized) orthoses. These orthoses are to be used in the standardized shoes provided to all subjects in the study. for use in their shoes.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
1021046|NCT00765843|B1|Baseline|Custom Foot Orthoses|"Subjects will receive custom fabricated orthoses created from casts of the feet and according to individualized prescriptions. These orthoses are to be used in the standardized shoes provided to all subjects in the study.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
1021047|NCT00765843|P3|Participant Flow|Sham Insoles|"Subjects will receive sham orthoses that are soft and pliable, but not designed to relieve pain. These orthoses are to be used in the standardized shoes provided to all subjects in the study.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
1021048|NCT00765843|P2|Participant Flow|Pre-fabricated Orthoses|"Subjects will be provided pre-fabricated (non-customized) orthoses. These orthoses are to be used in the standardized shoes provided to all subjects in the study. for use in their shoes.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
1021049|NCT00765843|P1|Participant Flow|Custom Foot Orthoses|"Subjects will receive custom fabricated orthoses created from casts of the feet and according to individualized prescriptions. These orthoses are to be used in the standardized shoes provided to all subjects in the study.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
1021050|NCT00765843|O3|Outcome|Sham Insoles|"Subjects will receive sham orthoses that are soft and pliable, but not designed to relieve pain. These orthoses are to be used in the standardized shoes provided to all subjects in the study.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
1021051|NCT00765843|O2|Outcome|Pre-fabricated Orthoses|"Subjects will be provided pre-fabricated (non-customized) orthoses. These orthoses are to be used in the standardized shoes provided to all subjects in the study. for use in their shoes.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
1021052|NCT00765843|O1|Outcome|Custom Foot Orthoses|"Subjects will receive custom fabricated orthoses created from casts of the feet and according to individualized prescriptions. These orthoses are to be used in the standardized shoes provided to all subjects in the study.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
1021053|NCT00765843|E3|Reported Event|Sham Insoles|"Subjects will receive sham orthoses that are soft and pliable, but not designed to relieve pain. These orthoses are to be used in the standardized shoes provided to all subjects in the study.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
1021054|NCT00765843|E2|Reported Event|Pre-fabricated Orthoses|"Subjects will be provided pre-fabricated (non-customized) orthoses. These orthoses are to be used in the standardized shoes provided to all subjects in the study. for use in their shoes.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
1021055|NCT00765843|E1|Reported Event|Custom Foot Orthoses|"Subjects will receive custom fabricated orthoses created from casts of the feet and according to individualized prescriptions. These orthoses are to be used in the standardized shoes provided to all subjects in the study.~orthoses: orthoses are provided for use in standardized shoes that all subjects receive"
1021057|NCT00765817|B2|Baseline|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021058|NCT00765817|B1|Baseline|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021059|NCT00765817|P2|Participant Flow|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021060|NCT00765817|P1|Participant Flow|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021061|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021062|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021063|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021064|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021065|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021066|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021067|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021068|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021069|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021070|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021071|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021072|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021073|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021074|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021075|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021076|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021077|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021078|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021079|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021080|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021081|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021082|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021083|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021084|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021085|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021086|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021087|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021088|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021089|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
1024998|NCT00758459|O1|Outcome|AZD1236|AZD1236
1021090|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021091|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021092|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021093|NCT00765817|O2|Outcome|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021094|NCT00765817|O1|Outcome|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021095|NCT00765817|E2|Reported Event|Placebo Arm|Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021096|NCT00765817|E1|Reported Event|Exenatide Arm|Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
1021097|NCT00765765|B1|Baseline|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
1021098|NCT00765765|P1|Participant Flow|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
1021099|NCT00765765|O1|Outcome|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
1021100|NCT00765765|O1|Outcome|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
1021101|NCT00765765|O1|Outcome|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
1021102|NCT00765765|O1|Outcome|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
1021103|NCT00765765|O1|Outcome|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
1021104|NCT00765765|O1|Outcome|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
1021105|NCT00765765|O1|Outcome|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
1021106|NCT00765765|E1|Reported Event|Ixabepilone and Hydroxychloroquine|"ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.~hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid."
1021107|NCT00765726|B1|Baseline|Xyntha|Xyntha [moroctocog alfa albumin free cell culture (AF-CC)] administered intravenously (IV) at a dose and frequency prescribed by the treating physician as per local standard of care for up to 2 years.
1021108|NCT00765726|P1|Participant Flow|Xyntha|Xyntha [moroctocog alfa albumin free cell culture (AF-CC)] administered intravenously (IV) at a dose and frequency prescribed by the treating physician as per local standard of care for up to 2 years.
1021109|NCT00765726|O1|Outcome|Xyntha|Xyntha [moroctocog alfa albumin free cell culture (AF-CC)] administered intravenously (IV) at a dose and frequency prescribed by the treating physician as per local standard of care for up to 2 years.
1021110|NCT00765726|E1|Reported Event|Xyntha|Xyntha [moroctocog alfa albumin free cell culture (AF-CC)] administered intravenously (IV) at a dose and frequency prescribed by the treating physician as per local standard of care for up to 2 years.
1021111|NCT00765674|B5|Baseline|Total|Total of all reporting groups
1021112|NCT00765674|B4|Baseline|Aliskiren / Amlodipine / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
1021113|NCT00765674|B3|Baseline|Amlodipine / Hydrochlorothiazide|Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
1021114|NCT00765674|B2|Baseline|Aliskiren / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
1021115|NCT00765674|B1|Baseline|Aliskiren / Amlodipine|Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
1022133|NCT00763451|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
1021116|NCT00765674|P4|Participant Flow|Aliskiren / Amlodipine / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
1021117|NCT00765674|P3|Participant Flow|Amlodipine / Hydrochlorothiazide|Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
1021118|NCT00765674|P2|Participant Flow|Aliskiren / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
1021119|NCT00765674|P1|Participant Flow|Aliskiren / Amlodipine|Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
1021120|NCT00765674|O4|Outcome|Aliskiren / Amlodipine / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
1021121|NCT00765674|O3|Outcome|Amlodipine / Hydrochlorothiazide|Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
1021122|NCT00765674|O2|Outcome|Aliskiren / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
1021123|NCT00765674|O1|Outcome|Aliskiren / Amlodipine|Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
1021124|NCT00765674|O4|Outcome|Aliskiren / Amlodipine / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
1021125|NCT00765674|O3|Outcome|Amlodipine / Hydrochlorothiazide|Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
1021126|NCT00765674|O2|Outcome|Aliskiren / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
1021127|NCT00765674|O1|Outcome|Aliskiren / Amlodipine|Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
1021311|NCT00765076|P2|Participant Flow|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
1021128|NCT00765674|O4|Outcome|Aliskiren / Amlodipine / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
1021129|NCT00765674|O3|Outcome|Amlodipine / Hydrochlorothiazide|Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
1021130|NCT00765674|O2|Outcome|Aliskiren / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
1021131|NCT00765674|O1|Outcome|Aliskiren / Amlodipine|Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
1021132|NCT00765674|O4|Outcome|Aliskiren / Amlodipine / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
1021133|NCT00765674|O3|Outcome|Amlodipine / Hydrochlorothiazide|Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
1021134|NCT00765674|O2|Outcome|Aliskiren / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
1021135|NCT00765674|O1|Outcome|Aliskiren / Amlodipine|Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
1021136|NCT00765674|E4|Reported Event|Aliskiren / Amlodipine / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
1021137|NCT00765674|E3|Reported Event|Amlodipine / Hydrochlorothiazide|Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed
1021138|NCT00765674|E2|Reported Event|Aliskiren / Hydrochlorothiazide|Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
1021139|NCT00765674|E1|Reported Event|Aliskiren / Amlodipine|Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.
1021140|NCT00765661|B3|Baseline|Total|Total of all reporting groups
1024999|NCT00758459|O2|Outcome|Placebo|Placebo
1021141|NCT00765661|B2|Baseline|Group B|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf®: Prograf® capsules, twice daily, orally"
1021142|NCT00765661|B1|Baseline|Gorup A|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~tacrolimus (Tacro™): LCP - Tacro™ tablets, orally"
1021143|NCT00765661|P2|Participant Flow|Group B|Randomized, parallel-group, open-label, multi-center study in adult de novo kidney transplant patients to demonstrate the pharmacokinetics and safety of Prograf capsules in the first 2 weeks after kidney transplantation. Eligible patients were randomized (1:1 ratio) within 12 hours after transplantation (Day 0) to receive Prograf capsules in 2 equally divided doses, starting at 0.1 mg/kg every 12 hours (0.2 mg/kg total daily dose) as recommended in the U.S. Prescribing Information
1021144|NCT00765661|P1|Participant Flow|Group A|Randomized, parallel group, open-label, multi-center study in adult de novo kidney transplant patients to demonstrate the pharmacokinetics and safety of LCP-Tacro tablets in the first 2 weeks after kidney transplantation. Eligible patients were randomized (1:1 ratio) within 12 hours after transplantation (Day 0) to receive LCP-Tacro tablets orally once daily (QD) in the morning, with an interval of 24 +/-1 hours between doses, starting at 0.14 mg/kg (the starting daily dose for African-American patients was 0.17 mg/kg)
1021145|NCT00765661|O2|Outcome|Group B|Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
1021146|NCT00765661|O1|Outcome|Group A|LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK) tacrolimus (Tacro™)
1021147|NCT00765661|O2|Outcome|Group B|Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
1021148|NCT00765661|O1|Outcome|Group A|LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK) tacrolimus (Tacro™)
1021149|NCT00765661|O2|Outcome|Group B|Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
1021150|NCT00765661|O1|Outcome|Group A|LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK) tacrolimus (Tacro™)
1021151|NCT00765661|O2|Outcome|Group B|Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
1021152|NCT00765661|O1|Outcome|Group A|LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK) tacrolimus (Tacro™)
1021153|NCT00765661|E2|Reported Event|Group B|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf®: Prograf® capsules, twice daily"
1021154|NCT00765661|E1|Reported Event|Group A|"LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)~tacrolimus (Tacro™): LCP - Tacro™ tablets"
1021155|NCT00765648|B3|Baseline|Total|Total of all reporting groups
1021156|NCT00765648|B2|Baseline|Bolus Labetalol Began at 20 mg Over 2 Minutes|Labetalol
1021157|NCT00765648|B1|Baseline|Nicardipine Dosing Was 5 mg/Hour|nicardipine intravenous
1021158|NCT00765648|P2|Participant Flow|Bolus Labetalol Began at 20 mg Over 2 Minutes|Labetalol
1021159|NCT00765648|P1|Participant Flow|Nicardipine Dosing Was 5 mg/Hour|nicardipine intravenous
1021160|NCT00765648|O2|Outcome|Labetalol|Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
1021161|NCT00765648|O1|Outcome|Nicardipine|Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.
1021162|NCT00765648|O2|Outcome|Labetalol|Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
1021163|NCT00765648|O1|Outcome|Nicardipine|Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.
1021164|NCT00765648|O2|Outcome|Labetalol|Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
1021165|NCT00765648|O1|Outcome|Nicardipine|Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.
1021166|NCT00765648|O2|Outcome|Labetalol|Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
1021167|NCT00765648|O1|Outcome|Nicardipine|Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.
1021168|NCT00765648|O2|Outcome|Labetalol|Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
1021169|NCT00765648|O1|Outcome|Nicardipine|Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.
1021170|NCT00765648|O2|Outcome|Labetalol|Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
1021171|NCT00765648|O1|Outcome|Nicardipine|Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.
1021172|NCT00765648|E2|Reported Event|Labetalol|Bolus Labetalol began at 20 mg over 2 minutes
1021173|NCT00765648|E1|Reported Event|Nicardipine|Nicardipine dosing was 5 mg/hour
1021174|NCT00765570|B3|Baseline|Total|Total of all reporting groups
1021175|NCT00765570|B2|Baseline|Treatment Group-2|Treatment Group 2: 15 treatments with standard radiation
1021176|NCT00765570|B1|Baseline|Treatment Group 1|Treatment Group 1: one treatment of Grid therapy followed by 15 treatments with standard radiation
1021177|NCT00765570|P2|Participant Flow|Treatment Group-2|Treatment Group 2:15 treatments with standard radiation
1021178|NCT00765570|P1|Participant Flow|Treatment Group 1|Treatment Group 1: one treatment of Grid therapy followed by 15 treatments with standard radiation
1021180|NCT00765570|O1|Outcome|Treatment Group 1|Treatment Group 1: one treatment of Grid therapy followed by 15 treatments with standard radiation
1021181|NCT00765570|O2|Outcome|Treatment Group-2|Treatment Group 2: 15 treatments with standard radiation
1021182|NCT00765570|O1|Outcome|Treatment Group 1|Treatment Group 1: one treatment of Grid therapy followed by 15 treatments with standard radiation
1021183|NCT00765570|E2|Reported Event|Treatment Group-2|Treatment Group 2-15 treatments with standard radiation
1021184|NCT00765570|E1|Reported Event|Treatment Group 1|Treatment Group 1-one treatment of Grid therapy followed by 15 treatments with standard radiation
1021185|NCT00765388|B1|Baseline|Entire Study Population|Includes groups randomized to receive SenSura Uro first and Hollister Uro first
1021186|NCT00765388|P2|Participant Flow|SenSura Uro First, Then Hollister Uro|SenSura Uro (test product) and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
1021187|NCT00765388|P1|Participant Flow|Hollister Uro First, Then SenSura Uro|SenSura Uro (test product) and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
1021188|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
1021189|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
1021190|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
1021191|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
1021192|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
1021193|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
1021194|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
1021195|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
1021196|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
1021197|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
1021198|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
1021199|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
1021200|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
1021201|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
1021202|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
1021203|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
1021204|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
1021205|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
1021206|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
1021207|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
1021208|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
1021209|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
1021210|NCT00765388|O2|Outcome|Hollister Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
1021211|NCT00765388|O1|Outcome|SenSura Uro|SenSura Uro (test product)and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
1021212|NCT00765388|E2|Reported Event|SenSura Uro|SenSura Uro (test product) and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
1021213|NCT00765388|E1|Reported Event|Hollister Uro|SenSura Uro (test product) and Hollister Uro (comparator) are CE-marked, non-sterile, 1-piece urostomy devices.
1021214|NCT00765375|B1|Baseline|Active on One Side and Placebo on the Other Side of Face|Botulinum Neurotoxin Type A (Botox) on one side of face, and bacteriostatic saline solution on the other side of face.
1021215|NCT00765375|P1|Participant Flow|Active on One Side, Placebo on the Other Side of Face|Botulinum Neurotoxin Type A (Botox) treatment on one side of the face and bacteriostatic saline solution (Placebo) on the other side of the face.
1021216|NCT00765375|O2|Outcome|2- Placebo|Saline Solution
1021217|NCT00765375|O1|Outcome|1- Active|Botulinum Neurotoxin Type A (Botox)
1021218|NCT00765375|E2|Reported Event|2- Placebo|Saline Solution
1021219|NCT00765375|E1|Reported Event|1- Active|Botulinum Neurotoxin Type A (Botox)
1021220|NCT00765362|B1|Baseline|Mobile Bearing Knee|Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
1021281|NCT00765128|O1|Outcome|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
1021282|NCT00765128|E2|Reported Event|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
1021313|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
1021221|NCT00765362|P1|Participant Flow|Mobile Bearing Knee|Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
1021222|NCT00765362|O1|Outcome|Mobile Bearing Knee|Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
1021223|NCT00765362|O1|Outcome|Mobile Bearing Knee|Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
1021224|NCT00765362|O1|Outcome|Mobile Bearing Knee|Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
1021225|NCT00765362|E1|Reported Event|Mobile Bearing Knee|Subjects who meet the inclusion/exclusion criteria and are treated and receive the Mobile Bearing Knee. The Encore Mobile Bearing Knee is intended for subjects presenting for a primary cemented knee replacement suffering from inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles. This design is indicated for subjects who have adequate, as judged by the physician, collateral ligamentous stability to support the implant.
1021226|NCT00765336|B3|Baseline|Total|Total of all reporting groups
1021227|NCT00765336|B2|Baseline|Placebo|daily dose of Placebo
1021228|NCT00765336|B1|Baseline|Minocycline Extended-Release Tablets|daily dose of 1 mg/kg minocycline extended-release tablets
1021229|NCT00765336|P2|Participant Flow|Placebo|daily dose of Placebo
1021230|NCT00765336|P1|Participant Flow|Minocycline Extended-Release Tablets|daily dose of 1 mg/kg minocycline extended-release tablets
1021231|NCT00765336|O2|Outcome|Placebo|daily dose of Placebo
1021232|NCT00765336|O1|Outcome|Minocycline Extended-Release Tablets|daily dose of 1 mg/kg minocycline extended-release tablets
1021233|NCT00765336|E2|Reported Event|Placebo|daily dose of Placebo
1021234|NCT00765336|E1|Reported Event|Minocycline Extended-Release Tablets|daily dose of 1 mg/kg minocycline extended-release tablets
1021235|NCT00765245|B3|Baseline|Total|Total of all reporting groups
1021236|NCT00765245|B2|Baseline|Arm II: Lenalidomide and Rituximab IV|"Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide 20 mg daily, Days 1-21, followed by 7 days rest (28-day cycle). Cycles will be repeated every 28 days for a total of 12 cycles~Rituximab: Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization."
1021237|NCT00765245|B1|Baseline|Arm I: Lenalidomide|Lenalidomide: Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
1021238|NCT00765245|P2|Participant Flow|Arm II: Lenalidomide and Rituximab IV|"Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide 20 mg daily, Days 1-21, followed by 7 days rest (28-day cycle). Cycles will be repeated every 28 days for a total of 12 cycles~Rituximab: Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization."
1021239|NCT00765245|P1|Participant Flow|Arm I: Lenalidomide|Lenalidomide: Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
1021240|NCT00765245|O2|Outcome|Arm II: Lenalidomide and Rituximab IV|"Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide 20 mg daily, Days 1-21, followed by 7 days rest (28-day cycle). Cycles will be repeated every 28 days for a total of 12 cycles~Rituximab: Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization."
1021241|NCT00765245|O1|Outcome|Arm I: Lenalidomide|Lenalidomide: Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
1021242|NCT00765245|O2|Outcome|Arm II: Lenalidomide and Rituximab IV|"Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide 20 mg daily, Days 1-21, followed by 7 days rest (28-day cycle). Cycles will be repeated every 28 days for a total of 12 cycles~Rituximab: Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization."
1021243|NCT00765245|O1|Outcome|Arm I: Lenalidomide|Lenalidomide: Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
1021283|NCT00765128|E1|Reported Event|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
1021312|NCT00765076|P1|Participant Flow|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
1021244|NCT00765245|O2|Outcome|Arm II: Lenalidomide and Rituximab IV|"Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide 20 mg daily, Days 1-21, followed by 7 days rest (28-day cycle). Cycles will be repeated every 28 days for a total of 12 cycles~Rituximab: Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization."
1021245|NCT00765245|O1|Outcome|Arm I: Lenalidomide|Lenalidomide: Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
1021246|NCT00765245|E2|Reported Event|Arm II: Lenalidomide and Rituximab IV|"Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide 20 mg daily, Days 1-21, followed by 7 days rest (28-day cycle). Cycles will be repeated every 28 days for a total of 12 cycles~Rituximab: Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization."
1021247|NCT00765245|E1|Reported Event|Arm I: Lenalidomide|Lenalidomide: Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
1021248|NCT00765232|B3|Baseline|Total|Total of all reporting groups
1021249|NCT00765232|B2|Baseline|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
1021250|NCT00765232|B1|Baseline|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
1021251|NCT00765232|P2|Participant Flow|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
1021252|NCT00765232|P1|Participant Flow|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
1021253|NCT00765232|O2|Outcome|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
1021254|NCT00765232|O1|Outcome|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
1021255|NCT00765232|O2|Outcome|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
1021256|NCT00765232|O1|Outcome|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
1021257|NCT00765232|E2|Reported Event|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
1021258|NCT00765232|E1|Reported Event|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
1021259|NCT00765206|B1|Baseline|Entire Study Population|
1021260|NCT00765206|P4|Participant Flow|Prilosec First, Then Zegerid (7-Day Dosing)|Participants received Prilosec OTC Tablets (omeprazole 20 mg) in the first intervention and Zegerid OTC Capsules (omeprazole 20 mg and sodium bicarbonate 1100 mg) in the second intervention (after washout period)
1021261|NCT00765206|P3|Participant Flow|Zegerid First, Then Prilosec ( 7-Day Dosing)|Participants received Zegerid OTC Capsules (omeprazole 20 mg and sodium bicarbonate 1100 mg) in the first intervention and Prilosec OTC Tablets (omeprazole 20 mg) in the second intervention (after washout period)
1021262|NCT00765206|P2|Participant Flow|Prilosec First, Then Zegerid (1-Day Dosing)|Participants received Prilosec OTC Tablets (omeprazole 20 mg) in the first intervention and Zegerid OTC Capsules (omeprazole 20 mg and sodium bicarbonate 1100 mg) in the second intervention (after washout period)
1021263|NCT00765206|P1|Participant Flow|Zegerid First, Then Prilosec (1- Day Dosing)|Participants received Zegerid Over-the-counter (OTC) Capsules (omeprazole 20 mg and sodium bicarbonate 1100 mg) in the first intervention and Prilosec OTC Tablets (omeprazole 20 mg) in the second intervention (after washout period)
1021264|NCT00765206|O2|Outcome|Prilosec|Participants in the 7-Day Dosing group. Measurements taken on the 7th day of Prilosec administration.
1021265|NCT00765206|O1|Outcome|Zegerid|Participants in the 7-Day Dosing group. Measurements taken on the 7th day of Zegerid administration.
1021266|NCT00765206|E2|Reported Event|Prilosec|Subjects who received a single dose of Prilosec per day for either 1 or 7 days.
1021267|NCT00765206|E1|Reported Event|Zegerid|Subjects who received a single dose of Zegerid per day for either 1 or 7 days.
1021268|NCT00765193|B1|Baseline|Skin Cancer Screening|Physicians examine, first, the problem area of skin and record result, and second, the full body and record result.
1021269|NCT00765193|P1|Participant Flow|Skin Cancer Screening|Physicians examine, first, the problem area of skin and record result, and second, the full body and record result.
1021270|NCT00765193|O2|Outcome|Full Body Examination|
1021271|NCT00765193|O1|Outcome|Problem Area Examination|
1021272|NCT00765193|E1|Reported Event|Skin Cancer Screening|Physicians examine, first, the problem area of skin and record result, and second, the full body and record result.
1021273|NCT00765128|B3|Baseline|Total|Total of all reporting groups
1021274|NCT00765128|B2|Baseline|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
1021275|NCT00765128|B1|Baseline|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
1021276|NCT00765128|P2|Participant Flow|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
1021277|NCT00765128|P1|Participant Flow|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
1021278|NCT00765128|O2|Outcome|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
1021279|NCT00765128|O1|Outcome|Ketorolac|90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
1021280|NCT00765128|O2|Outcome|Placebo|1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
1025000|NCT00758459|O1|Outcome|AZD1236|AZD1236
1021284|NCT00765102|B1|Baseline|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
1021285|NCT00765102|P1|Participant Flow|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
1021286|NCT00765102|O1|Outcome|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
1021287|NCT00765102|O1|Outcome|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
1021288|NCT00765102|O1|Outcome|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
1021289|NCT00765102|O1|Outcome|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
1021290|NCT00765102|O1|Outcome|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
1021291|NCT00765102|O2|Outcome|Romidepsin 10 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m^2.
1021292|NCT00765102|O1|Outcome|Romidepsin 8 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 8mg/m^2.
1021293|NCT00765102|O2|Outcome|Romidepsin 10 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m^2.
1021294|NCT00765102|O1|Outcome|Romidepsin 8 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 8mg/m^2.
1021295|NCT00765102|O2|Outcome|Romidepsin 10 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m^2.
1021296|NCT00765102|O1|Outcome|Romidepsin 8 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 8mg/m^2.
1021297|NCT00765102|O2|Outcome|Romidepsin 10 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m^2.
1021298|NCT00765102|O1|Outcome|Romidepsin 8 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 8mg/m^2.
1021299|NCT00765102|O2|Outcome|Romidepsin 10 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m^2.
1021300|NCT00765102|O1|Outcome|Romidepsin 8 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 8mg/m^2.
1021301|NCT00765102|O2|Outcome|Romidepsin 10 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m^2.
1021302|NCT00765102|O1|Outcome|Romidepsin 8 mg/m^2 + Bortezomib|Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 8mg/m^2.
1021303|NCT00765102|O1|Outcome|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
1021304|NCT00765102|O1|Outcome|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
1021305|NCT00765102|E1|Reported Event|Romidepsin + Bortezomib|"Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period.~Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles."
1021306|NCT00765076|B4|Baseline|Total|Total of all reporting groups
1021307|NCT00765076|B3|Baseline|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
1021308|NCT00765076|B2|Baseline|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
1021309|NCT00765076|B1|Baseline|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
1021310|NCT00765076|P3|Participant Flow|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
1022357|NCT00762970|O1|Outcome|Test Lens 1|Investigational soft contact lenses worn daily.
1021314|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
1021315|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
1021316|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
1021317|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
1021318|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
1021319|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
1021320|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
1021321|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
1021322|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
1021323|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
1021324|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
1021325|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
1021326|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
1021327|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
1021328|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
1021329|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
1021330|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
1021331|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
1021332|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
1021333|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
1021334|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
1021335|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
1021336|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
1021337|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
1021338|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
1021339|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
1021340|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
1021341|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
1021342|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
1021343|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
1021344|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
1021345|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
1021346|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
1021347|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
1021348|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
1021349|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
1021350|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
1021351|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
1021352|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
1021353|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
1021354|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
1021355|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
1021356|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
1021357|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
1021358|NCT00765076|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
1021359|NCT00765076|O2|Outcome|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
1021360|NCT00765076|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
1021361|NCT00765076|E3|Reported Event|Fluarix Young Group|Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0
1021362|NCT00765076|E2|Reported Event|Fluarix Elderly Group|Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0
1021363|NCT00765076|E1|Reported Event|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0
1021364|NCT00765063|B1|Baseline|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
1021365|NCT00765063|P1|Participant Flow|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
1021366|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
1021367|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
1021368|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
1021369|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
1021370|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
1021371|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
1021372|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
1021373|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
1021374|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
1021375|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
1021376|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
1021377|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
1021378|NCT00765063|O1|Outcome|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
1021379|NCT00765063|E1|Reported Event|Dalteparin|Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
1021380|NCT00765037|B1|Baseline|Encore RSP|Subjects who need treatment for rotator cuff deficiency or glenohumeral arthritis, received the Encore Reverse Shoulder Prosthesis and are willing to participate in the study.
1021381|NCT00765037|P1|Participant Flow|Encore RSP|Subjects who need treatment for rotator cuff deficiency or glenohumeral arthritis, received the Encore Reverse Shoulder Prosthesis and are willing to participate in the study.
1021382|NCT00765037|O1|Outcome|Encore RSP|Subjects who need treatment for rotator cuff deficiency or glenohumeral arthritis, received the Encore Reverse Shoulder Prosthesis and are willing to participate in the study.
1021383|NCT00765037|E1|Reported Event|Encore RSP|Subjects who need treatment for rotator cuff deficiency or glenohumeral arthritis, received the Encore Reverse Shoulder Prosthesis and are willing to participate in the study.
1021384|NCT00764946|B4|Baseline|Total|Total of all reporting groups
1021385|NCT00764946|B3|Baseline|Participants Treatment Naive|Participants with no previous HIV treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
1021386|NCT00764946|B2|Baseline|Participants Intolerant to Current Therapy|Participants with previous HIV treatment experience who could not tolerate the treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
1021387|NCT00764946|B1|Baseline|Participants Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
1021388|NCT00764946|P3|Participant Flow|Participants Treatment Naive|Participants with no previous HIV treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
1021389|NCT00764946|P2|Participant Flow|Participants Intolerant to Current Therapy|Participants with previous HIV treatment experience who could not tolerate the treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
1021390|NCT00764946|P1|Participant Flow|Participants Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg twice daily (b.i.d.) plus other antiretroviral agents at the discretion of the investigator.
1021391|NCT00764946|O3|Outcome|Treatment Naive|Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
1021392|NCT00764946|O2|Outcome|Treatment Experienced - Intolerant To Current Therapy|Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
1021393|NCT00764946|O1|Outcome|Treatment Experienced - Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
1021394|NCT00764946|O3|Outcome|Treatment Naive|Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
1021395|NCT00764946|O2|Outcome|Treatment Experienced - Intolerant To Current Therapy|Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
1021396|NCT00764946|O1|Outcome|Treatment Experienced - Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
1021397|NCT00764946|O3|Outcome|Treatment Naive|Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
1021398|NCT00764946|O2|Outcome|Treatment Experienced - Treatment Intolerant|Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
1021399|NCT00764946|O1|Outcome|Treatment Experienced - Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
1021400|NCT00764946|O3|Outcome|Treatment Naive|Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
1021401|NCT00764946|O2|Outcome|Treatment Experienced - Treatment Intolerant|Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
1021402|NCT00764946|O1|Outcome|Treatment Experienced - Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
1021403|NCT00764946|O3|Outcome|Treatment Naive|Participants with no previous HIV treatment were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
1021404|NCT00764946|O2|Outcome|Treatment Experienced - Treatment Intolerant|Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
1021405|NCT00764946|O1|Outcome|Treatment Experienced - Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
1021406|NCT00764946|O3|Outcome|Treatment Naive|
1021407|NCT00764946|O2|Outcome|Treatment-Experienced - Treatment Intolerant|
1021408|NCT00764946|O1|Outcome|Treatment Experienced - Failing Current Therapy|
1021409|NCT00764946|O3|Outcome|Treatment Naive|Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
1021410|NCT00764946|O2|Outcome|Treatment Experienced - Treatment Intolerant|Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
1021411|NCT00764946|O1|Outcome|Treatment Experienced - Failing Current Therapy|Participants with previous HIV treatment who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
1021412|NCT00764946|E3|Reported Event|Treatment Naive|Participants with no previous HIV treatment experience were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
1021413|NCT00764946|E2|Reported Event|Treatment Experienced - Intolerant To Current Therapy|Participants with previous HIV treatment experience who could not tolerate their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
1021414|NCT00764946|E1|Reported Event|Treatment Experienced - Failing Current Therapy|Participants with previous HIV treatment experience who did not respond to their current HIV therapy were treated with open-label raltegravir 400 mg b.i.d. plus other antiretroviral agents at the discretion of the investigator.
1021415|NCT00764881|B3|Baseline|Total|Total of all reporting groups
1021416|NCT00764881|B2|Baseline|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021417|NCT00764881|B1|Baseline|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021418|NCT00764881|P2|Participant Flow|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021419|NCT00764881|P1|Participant Flow|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021420|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021421|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021422|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021423|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1025001|NCT00758459|O2|Outcome|Placebo|Placebo
1021424|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021425|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021426|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021427|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021428|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021429|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021430|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021431|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021432|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021433|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021434|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021435|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021436|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021437|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021438|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021439|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021440|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021441|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021442|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021443|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021444|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021445|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021446|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021447|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021448|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021449|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021450|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021451|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1025002|NCT00758459|O1|Outcome|AZD1236|AZD1236
1021452|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021453|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021454|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021455|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021456|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021457|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021458|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021459|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021460|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021461|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021462|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021463|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021464|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021465|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021466|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021467|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021468|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021469|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021470|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021471|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021472|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021473|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021474|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021475|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021476|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021477|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021478|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021479|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1025003|NCT00758459|O2|Outcome|Placebo|Placebo
1021480|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021481|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021482|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021483|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021484|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021485|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021486|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021487|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021488|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021489|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021490|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021491|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021492|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021493|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021494|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021495|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021496|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021497|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021498|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021499|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021500|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021501|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021502|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021503|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021504|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021505|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021506|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021507|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1025004|NCT00758459|O1|Outcome|AZD1236|AZD1236
1021508|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021509|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021510|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021511|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021512|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021513|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021514|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021515|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021516|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021517|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021518|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021519|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021520|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021521|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021522|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021523|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021524|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021525|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021526|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021527|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021528|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021529|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021530|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021531|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021532|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021533|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021534|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021535|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1025005|NCT00758459|O2|Outcome|Placebo|Placebo
1021536|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021537|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021538|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021539|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021540|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021541|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021542|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021543|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021544|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021545|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021546|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021547|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021548|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021549|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021550|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021551|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021552|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021553|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021554|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021555|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021556|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021557|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021558|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021559|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021560|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021561|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021562|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021563|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1025006|NCT00758459|O1|Outcome|AZD1236|AZD1236
1021564|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021565|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021566|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021567|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021568|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021569|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021570|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021571|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021572|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021573|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021574|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021575|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021576|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021577|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021578|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021579|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021580|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021581|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021582|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021583|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021584|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021585|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021586|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021587|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021588|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021589|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021590|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021591|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1025007|NCT00758459|O2|Outcome|Placebo|Placebo
1021592|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021593|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021594|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021595|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021596|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021597|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021598|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021599|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021600|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021601|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021602|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021603|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021604|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021605|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021606|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021607|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021608|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021609|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021610|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021611|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021612|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021613|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021614|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021615|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021616|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021617|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021618|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021619|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1025008|NCT00758459|O1|Outcome|AZD1236|AZD1236
1021620|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021621|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021622|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021623|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021624|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021625|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021626|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021627|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021628|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021629|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021630|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021631|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021632|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021633|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021634|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021635|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021636|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021637|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021638|NCT00764881|O2|Outcome|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
1021639|NCT00764881|O1|Outcome|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
1021640|NCT00764881|E2|Reported Event|EE/LNG (Microgynon) + Placebo|Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles
1021641|NCT00764881|E1|Reported Event|EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles
1021642|NCT00764868|B1|Baseline|Lisdexamfetamine Dimesylate (LDX)|Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
1021643|NCT00764868|P1|Participant Flow|Lisdexamfetamine Dimesylate (LDX)|Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
1021644|NCT00764868|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
1021645|NCT00764868|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
1021646|NCT00764868|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
1021755|NCT00764504|O1|Outcome|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
1021647|NCT00764868|E1|Reported Event|Lisdexamfetamine Dimesylate (LDX)|Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).
1021648|NCT00764790|B4|Baseline|Total|Total of all reporting groups
1021649|NCT00764790|B3|Baseline|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021650|NCT00764790|B2|Baseline|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021651|NCT00764790|B1|Baseline|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021652|NCT00764790|P3|Participant Flow|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021653|NCT00764790|P2|Participant Flow|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021654|NCT00764790|P1|Participant Flow|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021655|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021656|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021657|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021658|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021659|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021660|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021661|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021662|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021663|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021664|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021665|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021797|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
1021798|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
1021666|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021667|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021668|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021669|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021670|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021671|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021672|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021673|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021674|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021675|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021676|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021677|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021678|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021679|NCT00764790|O3|Outcome|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021680|NCT00764790|O2|Outcome|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021681|NCT00764790|O1|Outcome|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021682|NCT00764790|E3|Reported Event|Fluzone Group|"Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021683|NCT00764790|E2|Reported Event|Fluarix Dose B Group|"Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021799|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
1021800|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
1021684|NCT00764790|E1|Reported Event|Fluarix Dose A Group|"Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).~* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses."
1021685|NCT00764673|B1|Baseline|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
1021686|NCT00764673|P1|Participant Flow|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
1021687|NCT00764673|O1|Outcome|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
1021688|NCT00764673|O1|Outcome|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
1021689|NCT00764673|O1|Outcome|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
1021690|NCT00764673|O1|Outcome|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
1021691|NCT00764673|O1|Outcome|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
1021692|NCT00764673|E1|Reported Event|Primary 3DKnee Implant|Subjects who require a knee implant that have not previously had a knee replacement in the operative knee.
1021693|NCT00764660|B3|Baseline|Total|Total of all reporting groups
1021694|NCT00764660|B2|Baseline|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
1021695|NCT00764660|B1|Baseline|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
1021696|NCT00764660|P2|Participant Flow|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
1021697|NCT00764660|P1|Participant Flow|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
1021698|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
1021699|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
1021700|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
1021701|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
1021702|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
1021703|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
1021704|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
1021705|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
1021706|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
1021707|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
1021708|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
1021709|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
1021710|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
1021711|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
1021712|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
1021713|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
1021714|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
1021715|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
1021716|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
1021717|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
1021718|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
1021719|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
1021720|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
1021721|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
1021722|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
1021723|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
1021724|NCT00764660|O2|Outcome|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
1021725|NCT00764660|O1|Outcome|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
1021726|NCT00764660|E2|Reported Event|Placebo|Participants received matching placebo tablets by mouth twice daily for 12 weeks.
1021727|NCT00764660|E1|Reported Event|SCH 900435 12 mg|Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks.
1021728|NCT00764504|B4|Baseline|Total|Total of all reporting groups
1021801|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
1025009|NCT00758459|O2|Outcome|Placebo|Placebo
1021729|NCT00764504|B3|Baseline|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
1021730|NCT00764504|B2|Baseline|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
1021731|NCT00764504|B1|Baseline|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
1021732|NCT00764504|P3|Participant Flow|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
1021733|NCT00764504|P2|Participant Flow|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
1021734|NCT00764504|P1|Participant Flow|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
1021735|NCT00764504|O3|Outcome|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
1021736|NCT00764504|O2|Outcome|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
1021737|NCT00764504|O1|Outcome|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
1021738|NCT00764504|O3|Outcome|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
1021739|NCT00764504|O2|Outcome|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
1021740|NCT00764504|O1|Outcome|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
1021741|NCT00764504|O3|Outcome|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
1021742|NCT00764504|O2|Outcome|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
1021743|NCT00764504|O1|Outcome|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
1021744|NCT00764504|O3|Outcome|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
1021745|NCT00764504|O2|Outcome|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
1021746|NCT00764504|O1|Outcome|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
1021747|NCT00764504|O3|Outcome|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
1021748|NCT00764504|O2|Outcome|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
1021749|NCT00764504|O1|Outcome|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
1021750|NCT00764504|O3|Outcome|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
1021751|NCT00764504|O2|Outcome|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
1021752|NCT00764504|O1|Outcome|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
1021753|NCT00764504|O3|Outcome|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
1021754|NCT00764504|O2|Outcome|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
1025010|NCT00758459|O1|Outcome|AZD1236|AZD1236
1021756|NCT00764504|E3|Reported Event|Continued Access|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
1021757|NCT00764504|E2|Reported Event|Revision|Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
1021758|NCT00764504|E1|Reported Event|Primary|Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
1021759|NCT00763490|B1|Baseline|Double Cord Blood Tranplant|Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
1021760|NCT00763490|P1|Participant Flow|Double Cord Blood Tranplant|Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
1021761|NCT00763490|O1|Outcome|Double Cord Blood Tranplant|Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
1021762|NCT00763490|O1|Outcome|Double Cord Blood Tranplant|Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
1021763|NCT00763490|O1|Outcome|Double Cord Blood Tranplant|Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
1021764|NCT00763490|O1|Outcome|Double Cord Blood Tranplant|Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
1021765|NCT00763490|E1|Reported Event|Double Cord Blood Tranplant|Full intensity, double umbilical cord, stem cell transplant: stem cell transplant using two umbilical cord blood units, combined with a Flu/Bu4 conditioning regimen prior to transplantation.
1021766|NCT00764478|B4|Baseline|Total|Total of all reporting groups
1021767|NCT00764478|B3|Baseline|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
1021768|NCT00764478|B2|Baseline|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
1021769|NCT00764478|B1|Baseline|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
1021770|NCT00764478|P3|Participant Flow|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
1021771|NCT00764478|P2|Participant Flow|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
1021772|NCT00764478|P1|Participant Flow|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually twice daily (BID) for 21 days
1021773|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
1021774|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
1021775|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
1021776|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
1021777|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
1021778|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
1021779|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
1021780|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
1021781|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
1021782|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
1021783|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
1021784|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
1021785|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
1021786|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
1021787|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
1021788|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
1021789|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
1021790|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
1021791|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
1021792|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
1021793|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
1021794|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
1021795|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
1021796|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
1022358|NCT00762970|E3|Reported Event|Control Lens|Control spectacle lenses worn daily.
1021802|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
1021803|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
1021804|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
1021805|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
1021806|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
1021807|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
1021808|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
1021809|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
1021810|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
1021811|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
1021812|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
1021813|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
1021814|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
1021815|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
1021816|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
1021817|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
1021818|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
1021819|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
1021820|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
1021821|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
1021822|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
1021823|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
1021824|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
1021825|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
1021826|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
1021827|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
1021828|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
1021829|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
1021830|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
1021831|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
1021832|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
1021833|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
1021834|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
1021835|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
1021836|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
1021837|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
1021838|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
1021839|NCT00764478|O3|Outcome|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
1021840|NCT00764478|O2|Outcome|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
1021841|NCT00764478|O1|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
1021842|NCT00764478|E3|Reported Event|Placebo BID|Participants were administered one asenapine-matched placebo tablet sublingually BID for 21 days
1021843|NCT00764478|E2|Reported Event|Asenapine 10 mg BID|Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
1021844|NCT00764478|E1|Reported Event|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
1021845|NCT00764465|B7|Baseline|Total|Total of all reporting groups
1021846|NCT00764465|B6|Baseline|Group F|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
1021847|NCT00764465|B5|Baseline|Group E|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
1021848|NCT00764465|B4|Baseline|Group D|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
1021849|NCT00764465|B3|Baseline|Group C|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID
1021850|NCT00764465|B2|Baseline|Group B|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID
1021851|NCT00764465|B1|Baseline|Group A|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Maraviroc 300mg BID
1021852|NCT00764465|P6|Participant Flow|Group F|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
1021853|NCT00764465|P5|Participant Flow|Group E|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg once daily (QD) + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
1021854|NCT00764465|P4|Participant Flow|Group D|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
1021855|NCT00764465|P3|Participant Flow|Group C|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID
1021856|NCT00764465|P2|Participant Flow|Group B|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID
1021857|NCT00764465|P1|Participant Flow|Group A|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Maraviroc 300mg BID
1021858|NCT00764465|O3|Outcome|Group E & F|"Group E Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID~Group F Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
1021859|NCT00764465|O2|Outcome|Group C & D|"Group C Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID~Group D Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
1021860|NCT00764465|O1|Outcome|Group A & B|"Group A Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID~Group B Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID"
1021861|NCT00764465|O3|Outcome|Group E & F|"Group E Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID~Group F Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
1021862|NCT00764465|O2|Outcome|Group C & D|"Group C Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID~Group D Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
1021863|NCT00764465|O1|Outcome|Group A & B|"Group A Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID~Group B Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID"
1021864|NCT00764465|O6|Outcome|Group F|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
1021865|NCT00764465|O5|Outcome|Group E|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
1021866|NCT00764465|O4|Outcome|Group D|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
1021867|NCT00764465|O3|Outcome|Group C|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID
1021868|NCT00764465|O2|Outcome|Group B|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID
1021869|NCT00764465|O1|Outcome|Group A|Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID
1021870|NCT00764465|O3|Outcome|Group E & F|"Group E Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID~Group F Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
1021871|NCT00764465|O2|Outcome|Group C & D|"Group C Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID~Group D Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
1021872|NCT00764465|O1|Outcome|Group A & B|"Group A Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID~Group B Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID"
1021873|NCT00764465|O3|Outcome|Group E & F|"Group E Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID~Group F Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
1021874|NCT00764465|O2|Outcome|Group C & D|"Group C Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID~Group D Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
1021875|NCT00764465|O1|Outcome|Group A & B|"Group A Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID~Group B Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID"
1021876|NCT00764465|E6|Reported Event|Group F|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
1021877|NCT00764465|E5|Reported Event|Group E|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Maraviroc 300mg BID
1021878|NCT00764465|E4|Reported Event|Group D|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
1021879|NCT00764465|E3|Reported Event|Group C|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Maraviroc 300mg BID
1021880|NCT00764465|E2|Reported Event|Group B|Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID
1021881|NCT00764465|E1|Reported Event|Group A|Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID
1021882|NCT00764361|B3|Baseline|Total|Total of all reporting groups
1021883|NCT00764361|B2|Baseline|Placebo|placebo gel
1021884|NCT00764361|B1|Baseline|NanoDOX™ Hydrogel|1.0% doxycycline gel
1021885|NCT00764361|P2|Participant Flow|Placebo|placebo gel
1021886|NCT00764361|P1|Participant Flow|NanoDOX™ Hydrogel|1.0% doxycycline gel
1021887|NCT00764361|O2|Outcome|Placebo|placebo gel
1021888|NCT00764361|O1|Outcome|NanoDOX™ Hydrogel|1.0% doxycycline monohydrate gel
1021889|NCT00764361|E2|Reported Event|Placebo|placebo gel
1021890|NCT00764361|E1|Reported Event|NanoDOX™ Hydrogel|1.0% doxycycline gel
1021891|NCT00764309|B1|Baseline|100 mg Dasatinib, Oral Administration|Participants received 100 mg dasatinib once daily orally for up to 2 years (6 months of dosing to evaluate the primary endpoint + 18 months of dosing to assess longer-term safety and efficacy)
1021892|NCT00764309|P1|Participant Flow|100 mg Dasatinib, Oral Administration|Participants received 100 mg dasatinib once daily orally for up to 2 years (6 months of dosing to evaluate the primary endpoint + 18 months of dosing to assess longer-term safety and efficacy)
1021893|NCT00764309|O1|Outcome|100 mg Dasatinib, Oral Administration|Participants received 100 mg dasatinib once daily orally for up to 2 years (6 months of dosing to evaluate the primary endpoint + 18 months of dosing to assess longer-term safety and efficacy)
1021894|NCT00764309|O1|Outcome|100 mg Dasatinib, Oral Administration|Participants received 100 mg dasatinib once daily orally for up to 2 years (6 months of dosing to evaluate the primary endpoint + 18 months of dosing to assess longer-term safety and efficacy)
1021895|NCT00764309|O1|Outcome|100 mg Dasatinib, Oral Administration|Participants received 100 mg dasatinib once daily orally for up to 2 years (6 months of dosing to evaluate the primary endpoint + 18 months of dosing to assess longer-term safety and efficacy)
1021896|NCT00764309|O1|Outcome|100 mg Dasatinib, Oral Administration|Participants received 100 mg dasatinib once daily orally for up to 2 years (6 months of dosing to evaluate the primary endpoint + 18 months of dosing to assess longer-term safety and efficacy)
1021897|NCT00764309|E1|Reported Event|Dasatinib|
1021898|NCT00763971|B4|Baseline|Total|Total of all reporting groups
1021899|NCT00763971|B3|Baseline|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
1021900|NCT00763971|B2|Baseline|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
1021901|NCT00763971|B1|Baseline|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
1021902|NCT00763971|P3|Participant Flow|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
1021903|NCT00763971|P2|Participant Flow|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
1021904|NCT00763971|P1|Participant Flow|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
1021905|NCT00763971|O3|Outcome|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
1021906|NCT00763971|O2|Outcome|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
1021907|NCT00763971|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
1021908|NCT00763971|O3|Outcome|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
1021909|NCT00763971|O2|Outcome|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
1021910|NCT00763971|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
1021911|NCT00763971|O3|Outcome|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
1021912|NCT00763971|O2|Outcome|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
1021913|NCT00763971|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
1021914|NCT00763971|O3|Outcome|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
1021915|NCT00763971|O2|Outcome|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
1021916|NCT00763971|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
1021917|NCT00763971|O3|Outcome|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
1021918|NCT00763971|O2|Outcome|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
1021919|NCT00763971|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
1021920|NCT00763971|O3|Outcome|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
1021921|NCT00763971|O2|Outcome|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
1021922|NCT00763971|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
1021923|NCT00763971|O3|Outcome|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
1021924|NCT00763971|O2|Outcome|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
1021925|NCT00763971|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
1021926|NCT00763971|O3|Outcome|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
1021927|NCT00763971|O2|Outcome|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
1021928|NCT00763971|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
1021929|NCT00763971|E3|Reported Event|Placebo|Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
1021930|NCT00763971|E2|Reported Event|Methylphenidate Hydrochloride|Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
1021931|NCT00763971|E1|Reported Event|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
1021932|NCT00763958|B3|Baseline|Total|Total of all reporting groups
1021933|NCT00763958|B2|Baseline|Placebo|"Medication sugar pill provided for 12 weeks up to 32 mg daily."
1021934|NCT00763958|B1|Baseline|Buprenorphine|Buprenorphine provided for 12 weeks up to 32 mg daily based on clinical assessment.
1021935|NCT00763958|P2|Participant Flow|Placebo|"Medication sugar pill provided for 12 weeks up to 32 mg daily."
1021936|NCT00763958|P1|Participant Flow|Buprenorphine|Buprenorphine provided for 12 weeks up to 32 mg daily based on clinical assessment.
1021937|NCT00763958|O2|Outcome|Placebo|"Medication sugar pill provided for 12 weeks."
1021938|NCT00763958|O1|Outcome|Buprenorphine|Buprenorphine provided for 12 weeks of study drug based on clinical assessment.
1021939|NCT00763958|O2|Outcome|Placebo|"Medication sugar pill provided for 12 weeks."
1021940|NCT00763958|O1|Outcome|Buprenorphine|Buprenorphine provided for 12 weeks of stuty drug based on clinical assessment.
1021941|NCT00763958|O2|Outcome|Placebo|"Medication sugar pill provided for 12 weeks."
1021942|NCT00763958|O1|Outcome|Buprenorphine|Buprenorphine provided for 12 weeks of study drug based on clinical assessment.
1021943|NCT00763958|E2|Reported Event|Placebo|"Medication sugar pill provided for 12 weeks up to 32 mg daily."
1021944|NCT00763958|E1|Reported Event|Buprenorphine|Buprenorphine provided for 12 weeks up to 32 mg daily based on clinical assessment.
1021945|NCT00763919|B1|Baseline|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
1021946|NCT00763919|P1|Participant Flow|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
1021947|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
1021948|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
1021949|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
1021950|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
1021987|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1021951|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
1021952|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
1021953|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
1021954|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
1021955|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
1021956|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
1021957|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
1021958|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
1021959|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
1021960|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
1021961|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
1021962|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
1021963|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
1021964|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
1021965|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
1021966|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
1021967|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
1021968|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
1021969|NCT00763919|O1|Outcome|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
1021970|NCT00763919|E1|Reported Event|Customized Adherence Enhancement (CAE)|Participants, all of whom have a history of medication nonadherence, will be assigned to one or more treatment modules of Customized Adherence Enhancement based on their individual profiles.
1021971|NCT00763867|B3|Baseline|Total|Total of all reporting groups
1021972|NCT00763867|B2|Baseline|Sildenafil|20 mg tid for 12 weeks followed by 60 mg tid for 12 weeks
1021973|NCT00763867|B1|Baseline|Placebo|20 mg tid for 12 weeks followed by 60 mg tid for 12 weeks
1021974|NCT00763867|P2|Participant Flow|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1021975|NCT00763867|P1|Participant Flow|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1021976|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1021977|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1021978|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1021979|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1021980|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1021981|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1021982|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1021983|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1021984|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1021985|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1021986|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1021988|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1021989|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1021990|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1021991|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1021992|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1021993|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1021994|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1021995|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1021996|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1021997|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1021998|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1021999|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022000|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022001|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022002|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022003|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022004|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022005|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022006|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022007|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022008|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022009|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022010|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022011|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022012|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022013|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022014|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022015|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022016|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022017|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022018|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022019|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022020|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022021|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022022|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022023|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022024|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022025|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022026|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022027|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022028|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022029|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022030|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022031|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022032|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022033|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022034|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022035|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022036|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022037|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022038|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022039|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022040|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022041|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022042|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022043|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1025011|NCT00758459|E2|Reported Event|Placebo|Placebo
1022044|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022045|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022046|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022047|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022048|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022049|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022050|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022051|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022052|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022053|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022054|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022055|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022056|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022057|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022058|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022059|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022060|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022061|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022062|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022063|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022064|NCT00763867|O2|Outcome|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022065|NCT00763867|O1|Outcome|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022066|NCT00763867|E2|Reported Event|Sildenafil|sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022067|NCT00763867|E1|Reported Event|Placebo|placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
1022068|NCT00763815|B3|Baseline|Total|Total of all reporting groups
1022069|NCT00763815|B2|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg once daily QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
1022070|NCT00763815|B1|Baseline|Placebo|2-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
1022071|NCT00763815|P2|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
1022072|NCT00763815|P1|Participant Flow|Placebo|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
1022073|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1022074|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1022075|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1022076|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1022077|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1022078|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1022079|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1022080|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1022081|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1022082|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1022083|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1022084|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1022085|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1022086|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1022087|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1022088|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1022089|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1022090|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1022091|NCT00763815|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1022092|NCT00763815|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1022093|NCT00763815|E2|Reported Event|Lixisenatide|2-step initiation regimen of lixisenatide.
1022094|NCT00763815|E1|Reported Event|Placebo|2-step initiation regimen of volume matching placebo.
1022095|NCT00763750|B1|Baseline|PPX +TMZ+XRT|"XRT 60Gy at 2 GY/fractions x 30 fractions TMZ 75mg/m2/day PPX 40mg/m2/week x 6 weeks Days 1,8,15,22,22,29,36~PPX +TMZ+XRT : PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays)"
1022096|NCT00763750|P1|Participant Flow|PPX +TMZ+XRT|"XRT 60Gy at 2 GY/fractions x 30 fractions TMZ 75mg/m2/day PPX 40mg/m2/week x 6 weeks Days 1,8,15,22,22,29,36~PPX +TMZ+XRT : PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays)"
1022132|NCT00763451|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
1022097|NCT00763750|O1|Outcome|PPX +TMZ+XRT|"XRT 60Gy at 2 GY/fractions x 30 fractions TMZ 75mg/m2/day PPX 40mg/m2/week x 6 weeks Days 1,8,15,22,22,29,36~PPX +TMZ+XRT : PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays)"
1022098|NCT00763750|E1|Reported Event|PPX +TMZ+XRT|"XRT 60Gy at 2 GY/fractions x 30 fractions TMZ 75mg/m2/day PPX 40mg/m2/week x 6 weeks Days 1,8,15,22,22,29,36~PPX +TMZ+XRT : PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays)"
1022099|NCT00763698|B1|Baseline|QuickFlex Micro 1258T Left Heart Lead|All patients received a QuickFlex Micro 1258T left heart lead and were evaluated for freedom from left ventricular lead complications at 3 months. Left ventricular lead related complications is defined as any adverse event related to the left ventricular lead that requires an invasive intervention.
1022100|NCT00763698|P1|Participant Flow|QuickFlex Micro 1258T Left Heart Lead|All patients received a QuickFlex Micro 1258T left heart lead and were evaluated for freedom from left ventricular lead complications at 3 months. Left ventricular lead related complications is defined as any adverse event related to the left ventricular lead that requires an invasive intervention.
1022101|NCT00763698|O1|Outcome|QuickFlex Micro 1258T Left Heart Leads|Patients included in this analysis include the first 16 patients to provide LV lead bipolar pacing capture threshold data at 3 months with a pulse width of 0.5 ms.
1022102|NCT00763698|O1|Outcome|QuickFlex Micro 1258T Left Heart Lead|All patients received a QuickFlex Micro 1258T left heart lead and were evaluated for freedom from left ventricular lead complications at 3 months. Left ventricular lead related complications is defined as any adverse event related to the left ventricular lead that requires an invasive intervention.
1022103|NCT00763698|O1|Outcome|QuickFlex Micro 1258T Left Heart Lead|All patients received a QuickFlex Micro 1258T left heart lead and were evaluated for freedom from left ventricular lead complications at 3 months. Left ventricular lead related complications is defined as any adverse event related to the left ventricular lead that requires an invasive intervention.
1022104|NCT00763698|E1|Reported Event|QuickFlex Micro 1258T Left Heart Lead|All patients received a QuickFlex Micro 1258T left heart lead and were evaluated for freedom from left ventricular lead complications at 3 months. Left ventricular lead related complications is defined as any adverse event related to the left ventricular lead that requires an invasive intervention.
1022105|NCT00763451|B5|Baseline|Total|Total of all reporting groups
1022106|NCT00763451|B4|Baseline|Lixisenatide (One-step Titration)|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to the end of treatment.
1022107|NCT00763451|B3|Baseline|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
1022108|NCT00763451|B2|Baseline|Placebo (One-step Titration)|1-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to the end of treatment.
1022109|NCT00763451|B1|Baseline|Placebo (Two-step Titration)|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
1022110|NCT00763451|P4|Participant Flow|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to the end of treatment.
1022111|NCT00763451|P3|Participant Flow|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
1022112|NCT00763451|P2|Participant Flow|Placebo (One-Step Titration)|1-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to the end of treatment.
1022113|NCT00763451|P1|Participant Flow|Placebo (Two-Step Titration)|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
1022114|NCT00763451|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
1022115|NCT00763451|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
1022116|NCT00763451|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
1022117|NCT00763451|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
1022118|NCT00763451|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
1022119|NCT00763451|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
1022120|NCT00763451|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
1022121|NCT00763451|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
1022122|NCT00763451|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
1022123|NCT00763451|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
1022124|NCT00763451|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
1022125|NCT00763451|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
1022126|NCT00763451|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
1022127|NCT00763451|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
1022128|NCT00763451|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
1022129|NCT00763451|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
1022130|NCT00763451|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
1022131|NCT00763451|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
1022134|NCT00763451|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
1022135|NCT00763451|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
1022136|NCT00763451|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
1022137|NCT00763451|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
1022138|NCT00763451|E6|Reported Event|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide and 1-step initiation regimen of lixisenatide.
1022139|NCT00763451|E5|Reported Event|Lixisenatide One-step Titration|1-step initiation regimen of lixisenatide.
1022140|NCT00763451|E4|Reported Event|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide.
1022141|NCT00763451|E3|Reported Event|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
1022142|NCT00763451|E2|Reported Event|Placebo (One-step Titration)|1-step initiation regimen of volume matching placebo.
1022143|NCT00763451|E1|Reported Event|Placebo (Two-step Titration)|2-step initiation regimen of volume matching placebo.
1022144|NCT00763412|B3|Baseline|Total|Total of all reporting groups
1022145|NCT00763412|B2|Baseline|Patients Who Received Repaglinide|All participants were receiving ADEK vitamins and pancreatic enzyme replacement. Patients were required to be clinically stable, without evidence of deterioration from previous pulmonary function tests (PFTs) for 3-months prior to the study and without CF exacerbation or hospitalization for 2-months prior to the study. Additionally, patients were required to have maintained stable weight within 5% variance for 3-months prior to participation. Exclusion criteria included fasting blood glucose levels >126 mg/dL on study day, IV antibiotic or systemic steroid use within two months, oral corticosteroid usage for more than 28-days over the past 6-months, history of lung or liver transplant, elevated transaminases, allergic bronchopulmonary aspergillosis, or the inability to perform spirometry.
1022146|NCT00763412|B1|Baseline|Patients Who Received Placebo|All participants were receiving ADEK vitamins and pancreatic enzyme replacement. Patients were required to be clinically stable, without evidence of deterioration from previous pulmonary function tests (PFTs) for 3-months prior to the study and without CF exacerbation or hospitalization for 2-months prior to the study. Additionally, patients were required to have maintained stable weight within 5% variance for 3-months prior to participation. Exclusion criteria included fasting blood glucose levels >126 mg/dL on study day, IV antibiotic or systemic steroid use within two months, oral corticosteroid usage for more than 28-days over the past 6-months, history of lung or liver transplant, elevated transaminases, allergic bronchopulmonary aspergillosis, or the inability to perform spirometry.
1022147|NCT00763412|P2|Participant Flow|2. Repaglinide|"repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.~repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
1022148|NCT00763412|P1|Participant Flow|Placebo|"1 pill before each meal 3-4 times a day for 2 years.~placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
1022149|NCT00763412|O2|Outcome|2. Repaglinide|"repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.~repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
1022150|NCT00763412|O1|Outcome|1 Placebo|"1 pill before each meal 3-4 times a day for 2 years.~placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
1022151|NCT00763412|O2|Outcome|2. Repaglinide|"repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.~repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
1022152|NCT00763412|O1|Outcome|1 Placebo|"1 pill before each meal 3-4 times a day for 2 years.~placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
1022153|NCT00763412|O2|Outcome|2. Repaglinide|"repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.~repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
1022154|NCT00763412|O1|Outcome|1 Placebo|"1 pill before each meal 3-4 times a day for 2 years.~placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
1022155|NCT00763412|O2|Outcome|2. Repaglinide|"repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.~repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
1022156|NCT00763412|O1|Outcome|1 Placebo|"1 pill before each meal 3-4 times a day for 2 years.~placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
1022157|NCT00763412|O2|Outcome|2. Repaglinide|"repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.~repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
1022158|NCT00763412|O1|Outcome|1 Placebo|"1 pill before each meal 3-4 times a day for 2 years.~placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
1022159|NCT00763412|O2|Outcome|2. Repaglinide|"repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.~repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
1022160|NCT00763412|O1|Outcome|1 Placebo|"1 pill before each meal 3-4 times a day for 2 years.~placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
1022161|NCT00763412|O2|Outcome|2. Repaglinide|"repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.~repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
1022162|NCT00763412|O1|Outcome|1 Placebo|"1 pill before each meal 3-4 times a day for 2 years.~placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
1022163|NCT00763412|O2|Outcome|2. Repaglinide|"repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.~repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
1022164|NCT00763412|O1|Outcome|1 Placebo|"1 pill before each meal 3-4 times a day for 2 years.~placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
1022165|NCT00763412|O2|Outcome|2. Repaglinide|"repaglinide 0.5 mg before each meal 3-4 times a day for 2 years.~repaglinide: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
1022166|NCT00763412|O1|Outcome|1 Placebo|"1 pill before each meal 3-4 times a day for 2 years.~placebo: CF pancreatic insufficient patients with prediabetes by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years."
1022167|NCT00763412|E2|Reported Event|Repaglinide|Repaglinide intervention group of CF pancreatic insufficient patients ages 12-24 years old with impaired glucose tolerance test (IGT) or CFRD without fasting hyperglycemia (CFRD-No FH).
1022168|NCT00763412|E1|Reported Event|Placebo|Placebo group of CF pancreatic insufficient patients ages 12-24 years old with impaired glucose tolerance test (IGT) or CFRD without fasting hyperglycemia (CFRD-No FH).
1022169|NCT00763386|B3|Baseline|Total|Total of all reporting groups
1022170|NCT00763386|B2|Baseline|LPS Standard Knee|Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
1022171|NCT00763386|B1|Baseline|LPS Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
1022172|NCT00763386|P2|Participant Flow|LPS Standard Knee|Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
1022173|NCT00763386|P1|Participant Flow|LPS Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
1022174|NCT00763386|O2|Outcome|LPS Standard Knee|Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
1022175|NCT00763386|O1|Outcome|LPS Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
1022176|NCT00763386|O2|Outcome|LPS Standard Knee|Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
1022177|NCT00763386|O1|Outcome|LPS Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
1022178|NCT00763386|E2|Reported Event|LPS Standard Knee|Study arm will consist of patients that are treated with the NexGen Legacy Posterior Stabilized Knee.
1022179|NCT00763386|E1|Reported Event|LPS Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen LPS-Flex Fixed Bearing Knee.
1022180|NCT00763360|B4|Baseline|Total|Total of all reporting groups
1022181|NCT00763360|B3|Baseline|Amvisc Plus|Amvisc Plus
1022182|NCT00763360|B2|Baseline|Healon|Healon
1022183|NCT00763360|B1|Baseline|DisCoVisc®|DisCoVisc® Ophthalmic Viscosurgical Device
1022184|NCT00763360|P3|Participant Flow|Amvisc Plus|Amvisc Plus
1022185|NCT00763360|P2|Participant Flow|Healon|Healon
1022186|NCT00763360|P1|Participant Flow|DisCoVisc®|DisCoVisc® Ophthalmic Viscosurgical Device
1022187|NCT00763360|O3|Outcome|Amvisc Plus|Amvisc Plus
1022188|NCT00763360|O2|Outcome|Healon|Healon
1022189|NCT00763360|O1|Outcome|DisCoVisc®|DisCoVisc® Ophthalmic Viscosurgical Device
1022190|NCT00763360|O3|Outcome|Amvisc Plus|Amvisc Plus
1022191|NCT00763360|O2|Outcome|Healon|Healon
1022192|NCT00763360|O1|Outcome|DisCoVisc®|DisCoVisc® Ophthalmic Viscosurgical Device
1022193|NCT00763360|O3|Outcome|Amvisc Plus|Amvisc Plus
1022194|NCT00763360|O2|Outcome|Healon|Healon
1022195|NCT00763360|O1|Outcome|DisCoVisc®|DisCoVisc® Ophthalmic Viscosurgical Device
1022196|NCT00763360|O3|Outcome|Amvisc Plus|Amvisc Plus
1022197|NCT00763360|O2|Outcome|Healon|Healon
1022198|NCT00763360|O1|Outcome|DisCoVisc®|DisCoVisc® Ophthalmic Viscosurgical Device
1022199|NCT00763360|E3|Reported Event|Amvisc Plus|Amvisc Plus
1022200|NCT00763360|E2|Reported Event|Healon|Healon
1022201|NCT00763360|E1|Reported Event|DisCoVisc®|DisCoVisc® Ophthalmic Viscosurgical Device
1022202|NCT00763321|B4|Baseline|Total|Total of all reporting groups
1022203|NCT00763321|B3|Baseline|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
1022204|NCT00763321|B2|Baseline|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
1022205|NCT00763321|B1|Baseline|Nonrandomized|2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks during the open-label period. These participants enrolled in the study and received at least 1 dose of study drug, and either discontinued during the open-label period or were not randomized and did not progress to the double-blind period.
1022206|NCT00763321|P3|Participant Flow|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
1022207|NCT00763321|P2|Participant Flow|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
1025012|NCT00758459|E1|Reported Event|AZD1236|AZD1236
1022208|NCT00763321|P1|Participant Flow|Open-label ABT-712|2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).
1022209|NCT00763321|O2|Outcome|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
1022210|NCT00763321|O1|Outcome|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
1022211|NCT00763321|O2|Outcome|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
1022212|NCT00763321|O1|Outcome|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
1022213|NCT00763321|E3|Reported Event|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
1022214|NCT00763321|E2|Reported Event|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
1022215|NCT00763321|E1|Reported Event|Open-label ABT-712|2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).
1022216|NCT00763282|B3|Baseline|Total|Total of all reporting groups
1022217|NCT00763282|B2|Baseline|Education (ED)|"Education (ED)~Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
1022218|NCT00763282|B1|Baseline|Self Management (SM) + Motivational Interviewing (MI)|"Self Management (SM) + Motivational Interviewing (MI)~Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology."
1022219|NCT00763282|P2|Participant Flow|Education (ED)|"Education (ED)~Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
1022220|NCT00763282|P1|Participant Flow|Self Management (SM) + Motivational Interviewing (MI)|"Self Management (SM) + Motivational Interviewing (MI)~Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology."
1022221|NCT00763282|O2|Outcome|ED Group|"An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care.~The ED intervention differs only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
1022222|NCT00763282|O1|Outcome|SM+MI Group|Self Management (SM) + Motivational Interviewing (MI). Motivational Interviewing (MI) is an evidence-based form of counseling to improve behavior change. Self Management (SM) includes: 1) ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using MI to support ongoing self-management activities, and 5) distance technology.
1022223|NCT00763282|O2|Outcome|Education (ED)|"Education (ED)~Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
1022224|NCT00763282|O1|Outcome|Self Management (SM) + Motivational Interviewing (MI)|"Self Management (SM) + Motivational Interviewing (MI)~Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology."
1022225|NCT00763282|O2|Outcome|Education (ED)|"Education (ED)~Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
1022226|NCT00763282|O1|Outcome|Self Management (SM) + Motivational Interviewing (MI)|"Self Management (SM) + Motivational Interviewing (MI)~Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology."
1022359|NCT00762970|E2|Reported Event|Test Lens 2|Investigational soft contact lenses worn daily.
1022227|NCT00763282|O2|Outcome|Education (ED)|"Education (ED)~Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
1022228|NCT00763282|O1|Outcome|Self Management (SM) + Motivational Interviewing (MI)|"Self Management (SM) + Motivational Interviewing (MI)~Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology."
1022229|NCT00763282|O2|Outcome|Education (ED)|"Education (ED)~Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
1022230|NCT00763282|O1|Outcome|Self Management (SM) + Motivational Interviewing (MI)|"Self Management (SM) + Motivational Interviewing (MI)~Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology."
1022231|NCT00763282|E2|Reported Event|Education (ED)|"Education (ED)~Education (ED): An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care."
1022232|NCT00763282|E1|Reported Event|Self Management (SM) + Motivational Interviewing (MI)|"Self Management (SM) + Motivational Interviewing (MI)~Self Management and Motivational Interviewing (SM+MI): Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using motivational interviewing to support ongoing self-management activities, and 5) distance technology."
1022233|NCT00763269|B3|Baseline|Total|Total of all reporting groups
1022234|NCT00763269|B2|Baseline|B -Control Toothpaste|Fluoride/Triclosan control toothpaste
1022235|NCT00763269|B1|Baseline|A-Experimental Toothpatse|fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
1022236|NCT00763269|P2|Participant Flow|B -Control Toothpaste|Fluoride/Triclosan control toothpaste
1022237|NCT00763269|P1|Participant Flow|A-Experimental Toothpatse|fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
1022238|NCT00763269|O2|Outcome|B -Control Toothpaste|Fluoride/Triclosan control toothpaste
1022239|NCT00763269|O1|Outcome|A-Experimental Toothpatse|fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
1022240|NCT00763269|O2|Outcome|B -Control Toothpaste|Fluoride/Triclosan control toothpaste
1022241|NCT00763269|O1|Outcome|A-Experimental Toothpatse|fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
1022242|NCT00763269|O2|Outcome|B -Control Toothpaste|Fluoride/Triclosan control toothpaste
1022243|NCT00763269|O1|Outcome|A-Experimental Toothpatse|fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
1022244|NCT00763269|O2|Outcome|B -Control Toothpaste|Fluoride/Triclosan control toothpaste
1022245|NCT00763269|O1|Outcome|A-Experimental Toothpatse|fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
1022246|NCT00763269|E2|Reported Event|B -Control Toothpaste|Fluoride/Triclosan control toothpaste
1022247|NCT00763269|E1|Reported Event|A-Experimental Toothpatse|fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula)
1022248|NCT00763256|B3|Baseline|Total|Total of all reporting groups
1022249|NCT00763256|B2|Baseline|B - Placebo Comparator|fluoride only toothpaste
1022250|NCT00763256|B1|Baseline|Active Comparator|triclosan/fluoride/copolymer toothpaste
1022251|NCT00763256|P2|Participant Flow|B - Placebo Comparator|fluoride only toothpaste
1022252|NCT00763256|P1|Participant Flow|Active Comparator|triclosan/fluoride/copolymer toothpaste
1022253|NCT00763256|O2|Outcome|B - Placebo Comparator|fluoride only toothpaste
1022254|NCT00763256|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
1022255|NCT00763256|O2|Outcome|B - Placebo Comparator|fluoride only toothpaste
1022256|NCT00763256|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
1022257|NCT00763256|O2|Outcome|B - Placebo Comparator|fluoride only toothpaste
1022258|NCT00763256|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
1022259|NCT00763256|O2|Outcome|B - Placebo Comparator|fluoride only toothpaste
1022260|NCT00763256|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
1022261|NCT00763256|O2|Outcome|B - Placebo Comparator|fluoride only toothpaste
1022262|NCT00763256|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
1022263|NCT00763256|E2|Reported Event|B - Placebo Comparator|fluoride only toothpaste
1022264|NCT00763256|E1|Reported Event|Active Comparator|triclosan/fluoride/copolymer toothpaste
1022305|NCT00763048|P1|Participant Flow|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
1022406|NCT00762788|O6|Outcome|Etafilcon A Contact Lens|ACUVUE 2
1022265|NCT00763139|B1|Baseline|Baseline Characteristics of Participants|participants who met American College of Rheumatology (ACR) criteria for rheumatoid arthritis (RA), age 18 or older, with moderate disease activity and no change in immunomodulating or anti-inflammatory therapy in past month
1022266|NCT00763139|P2|Participant Flow|Pioglitazone 1st, Placebo 2nd|"Pioglitazone for first 8 weeks, then washout period for 4 weeks, and finally placebo for 8 weeks.~Pioglitazone: 45 mg by mouth once a day for 8 weeks~Placebo: By mouth once a day for 8 weeks"
1022267|NCT00763139|P1|Participant Flow|Placebo 1st, Pioglitazone 2nd|"Placebo for first 8 weeks, then washout period for 4 weeks, and finally pioglitazone for 8 weeks.~Pioglitazone: 45 mg by mouth once a day for 8 weeks~Placebo: By mouth once a day for 8 weeks"
1022268|NCT00763139|O4|Outcome|Placebo Phase After 8 Weeks|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Results after 8 weeks are reported here.
1022269|NCT00763139|O3|Outcome|Placebo Phase Baseline|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Baseline results are reported here.
1022270|NCT00763139|O2|Outcome|Pioglitazone Phase After 8 Weeks|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Results after 8 weeks are reported here.
1022271|NCT00763139|O1|Outcome|Pioglitazone Phase Baseline|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Baseline results are reported here.
1022272|NCT00763139|O4|Outcome|Placebo Phase wk After 8 Weeks|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Results after 8 weeks on medication are reported here.
1022273|NCT00763139|O3|Outcome|Placebo Phase Baseline|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Baseline results are reported here.
1022274|NCT00763139|O2|Outcome|Pioglitazone Phase After 8 Weeks|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Results after 8 weeks on medication are reported here.
1022275|NCT00763139|O1|Outcome|Pioglitazone Phase Baseline|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Baseline results are reported here.
1022276|NCT00763139|O4|Outcome|Placebo Phase wk 8/20|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Results after 8 weeks are reported here.
1022277|NCT00763139|O3|Outcome|Placebo Phase Baseline|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Baseline results are reported here.
1022278|NCT00763139|O2|Outcome|Pioglitazone Phase After 8 Weeks|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Results after 8 weeks on medication are reported here.
1022279|NCT00763139|O1|Outcome|Pioglitazone Phase Baseline|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Baseline results are reported here.
1022280|NCT00763139|O4|Outcome|Placebo Phase wk 8/20|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Results after 8 weeks are reported here.
1022281|NCT00763139|O3|Outcome|Placebo Phase Baseline|All participants who took placebo in phase one or phase 2 of the study were combined to compare to the pioglitazone phase. Baseline results are reported here.
1022282|NCT00763139|O2|Outcome|Pioglitazone Phase After 8 Weeks|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Results after 8 weeks are reported here.
1022283|NCT00763139|O1|Outcome|Pioglitazone Phase Baseline|All participants who took pioglitazone in phase one or phase 2 of the study were combined to compare to the placebo phase. Baseline results are reported here.
1022284|NCT00763139|E2|Reported Event|Placebo|participants who met ACR criteria for RA, age 18 or older, with moderate disease activity and no change in immunomodulating or anti-inflammatory therapy in past month, during the period they were taking placebo
1022285|NCT00763139|E1|Reported Event|Pioglitazone|participants who met ACR criteria for RA, age 18 or older, with moderate disease activity and no change in immunomodulating or anti-inflammatory therapy in past month, during the period they were taking pioglitazone
1022286|NCT00763061|B3|Baseline|Total|Total of all reporting groups
1022287|NCT00763061|B2|Baseline|Timolol 0.5%|Timolol in each eye, twice daily at 9 AM & 9 PM
1022288|NCT00763061|B1|Baseline|Travoprost 0.004%|Travoprost at 9 AM + Placebo & 9 PM
1022289|NCT00763061|P2|Participant Flow|Timolol 0.5%|Timolol in each eye, twice daily at 9 AM & 9 PM
1022290|NCT00763061|P1|Participant Flow|Travoprost 0.004%|Travoprost at 9 AM + Placebo & 9 PM
1022291|NCT00763061|O2|Outcome|Timolol 0.5%|Timolol in each eye, twice daily at 9 AM & 9 PM
1022292|NCT00763061|O1|Outcome|Travoprost 0.004%|Travoprost at 9 AM + Placebo & 9 PM
1022293|NCT00763061|O2|Outcome|Timolol 0.5%|Timolol in each eye, twice daily at 9 AM & 9 PM
1022294|NCT00763061|O1|Outcome|Travoprost 0.004%|Travoprost at 9 AM + Placebo & 9 PM
1022295|NCT00763061|O2|Outcome|Timolol 0.5%|Timolol in each eye, twice daily at 9 AM & 9 PM
1022296|NCT00763061|O1|Outcome|Travoprost 0.004%|Travoprost at 9 AM + Placebo & 9 PM
1022297|NCT00763061|O2|Outcome|Timolol 0.5%|Timolol in each eye, twice daily at 9 AM & 9 PM
1022298|NCT00763061|O1|Outcome|Travoprost 0.004%|Travoprost at 9 AM + Placebo & 9 PM
1022299|NCT00763061|E2|Reported Event|Timolol 0.5%|Timolol in each eye, twice daily at 9 AM & 9 PM
1022300|NCT00763061|E1|Reported Event|Travoprost 0.004%|Travoprost at 9 AM + Placebo & 9 PM
1022301|NCT00763048|B3|Baseline|Total|Total of all reporting groups
1022302|NCT00763048|B2|Baseline|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
1022303|NCT00763048|B1|Baseline|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
1022304|NCT00763048|P2|Participant Flow|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
1022306|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
1022307|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
1022308|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
1022309|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
1022310|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
1022311|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
1022312|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
1022313|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
1022314|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
1022315|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
1022316|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
1022317|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
1022318|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
1022319|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
1022320|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
1022321|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
1022322|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
1022323|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
1022324|NCT00763048|O2|Outcome|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
1022325|NCT00763048|O1|Outcome|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
1022326|NCT00763048|E2|Reported Event|B - Active Comparator|Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks.
1022327|NCT00763048|E1|Reported Event|A - Control Comparator|Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks.
1022328|NCT00763009|B1|Baseline|Dipyridamole|Pre Results prior to Dipyridamole Post: Results post Dipyridamole
1022329|NCT00763009|P1|Participant Flow|All Subjects Receive Dipyridamole|"There is only a single arm~dipyridamole: 0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously"
1022330|NCT00763009|O1|Outcome|All Subjects Receive Dipyridamole|"There is only a single arm~dipyridamole: 0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously"
1022331|NCT00763009|E1|Reported Event|All Subjects Receive Dipyridamole|"There is only a single arm~dipyridamole: 0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously"
1022332|NCT00762996|B1|Baseline|Entire Population|
1022333|NCT00762996|P4|Participant Flow|Omafilcon A / Omafilcon A|Period 1: omafilcon A, Period 2: omafilcon A
1022334|NCT00762996|P3|Participant Flow|Omafilcon A / Etafilcon A|Period 1: omafilcon A, Period 2: etafilcon A
1022335|NCT00762996|P2|Participant Flow|Etafilcon A / Omafilcon A|Period 1: etafilcon A, Period 2: omafilcon A
1022336|NCT00762996|P1|Participant Flow|Etafilcon A / Etafilcon A|Period 1: etafilcon A, Period 2: etafilcon A
1022337|NCT00762996|O2|Outcome|Omafilcon A|
1022338|NCT00762996|O1|Outcome|Etafilcon A|
1022339|NCT00762996|O2|Outcome|Omafilcon A|
1022340|NCT00762996|O1|Outcome|Etafilcon A|
1022341|NCT00762996|E4|Reported Event|Omafilcon A / Omafilcon A|Period 1: omafilcon A, Period 2: omafilcon A
1022342|NCT00762996|E3|Reported Event|Omafilcon A / Etafilcon A|Period 1: omafilcon A, Period 2: etafilcon A
1022343|NCT00762996|E2|Reported Event|Etafilcon A / Omafilcon A|Period 1: etafilcon A, Period 2: omafilcon A
1022344|NCT00762996|E1|Reported Event|Etafilcon A / Etafilcon A|Period 1: etafilcon A, Period 2: etafilcon A
1022345|NCT00762970|B4|Baseline|Total|Total of all reporting groups
1022346|NCT00762970|B3|Baseline|Control Lens|Spectacle lenses worn daily.
1022347|NCT00762970|B2|Baseline|Test Lens 2|Investigational soft contact lens worn daily.
1022348|NCT00762970|B1|Baseline|Test Lens 1|Investigational soft contact lens worn daily.
1022349|NCT00762970|P3|Participant Flow|Control Lens|Control spectacle lenses worn daily.
1022350|NCT00762970|P2|Participant Flow|Test Lens 2|Investigational soft contact lenses worn daily.
1022351|NCT00762970|P1|Participant Flow|Test Lens 1|Investigational soft contact lenses worn daily.
1022352|NCT00762970|O3|Outcome|Control Lens|Spectacle lenses worn daily.
1022353|NCT00762970|O2|Outcome|Test Lens 2|Investigational soft contact lenses worn daily.
1022354|NCT00762970|O1|Outcome|Test Lens 1|Investigational soft contact lenses worn daily.
1022355|NCT00762970|O3|Outcome|Control Lens|Spectacle lenses worn daily.
1022356|NCT00762970|O2|Outcome|Test Lens 2|Investigational soft contact lenses worn daily.
1022360|NCT00762970|E1|Reported Event|Test Lens 1|Investigational soft contact lenses worn daily.
1022361|NCT00762892|B3|Baseline|Total|Total of all reporting groups
1022362|NCT00762892|B2|Baseline|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)~Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
1022363|NCT00762892|B1|Baseline|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)~Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
1022364|NCT00762892|P2|Participant Flow|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)~Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
1022365|NCT00762892|P1|Participant Flow|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)~Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
1022366|NCT00762892|O2|Outcome|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)~Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
1022367|NCT00762892|O1|Outcome|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)~Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
1022368|NCT00762892|O2|Outcome|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)~Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
1022369|NCT00762892|O1|Outcome|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)~Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
1022370|NCT00762892|O2|Outcome|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)~Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
1022371|NCT00762892|O1|Outcome|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)~Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
1022372|NCT00762892|O2|Outcome|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)~Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
1022373|NCT00762892|O1|Outcome|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)~Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
1022374|NCT00762892|O2|Outcome|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)~Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
1022375|NCT00762892|O1|Outcome|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)~Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
1022376|NCT00762892|E2|Reported Event|Atazanavir|"Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)~Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily"
1022377|NCT00762892|E1|Reported Event|Raltegravir|"Raltegravir in combination with truvada (tenofovir and emtricitabine)~Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily"
1022378|NCT00762853|B3|Baseline|Total|Total of all reporting groups
1022379|NCT00762853|B2|Baseline|Active Toothpaste First, Then Placebo|Subjects brushed their teeth with the fluoride/triclosan(Active) toothpaste during the first intervention, then brushed with the fluoride alone toothpaste(placebo) during the second intervention.
1022380|NCT00762853|B1|Baseline|Placebo First, Active Second|subjects brushed their teeth with Fluoride toothpaste (Placebo) during the first intervention, then brushed with the fluoride/triclosan (Active) toothpaste during the second intervention.
1022381|NCT00762853|P2|Participant Flow|Active Toothpaste First, Then Placebo|Subjects brushed their teeth with the fluoride/triclosan(Active) toothpaste during the first intervention, then brushed with the fluoride alone toothpaste(placebo) during the second intervention.
1022382|NCT00762853|P1|Participant Flow|Placebo First, Active Second|subjects brushed their teeth with Fluoride toothpaste (Placebo) during the first intervention, then brushed with the fluoride/triclosan (Active) toothpaste during the second intervention.
1022383|NCT00762853|O2|Outcome|Active Toothpaste|fluoride/triclosan/copolymer(Active) toothpaste
1022384|NCT00762853|O1|Outcome|Fluoride Toothpaste (Placebo)|fluoride only toothpaste
1022385|NCT00762853|E2|Reported Event|Active Toothpaste First, Then Placebo|Subjects brushed their teeth with the fluoride/triclosan(Active) toothpaste during the first intervention, then brushed with the fluoride alone toothpaste(placebo) during the second intervention.
1022386|NCT00762853|E1|Reported Event|Placebo First, Active Second|subjects brushed their teeth with Fluoride toothpaste (Placebo) during the first intervention, then brushed with the fluoride/triclosan (Active) toothpaste during the second intervention.
1022387|NCT00762788|B7|Baseline|Total|Total of all reporting groups
1022388|NCT00762788|B6|Baseline|Etafilcon A Contact Lens|ACUVUE 2
1022389|NCT00762788|B5|Baseline|Comfilcon A Contact Lens|Biofinity
1022390|NCT00762788|B4|Baseline|Balafilcon A Contact Lens|PureVision
1022391|NCT00762788|B3|Baseline|Lotrafilcon B Contact Lens|O2Optix
1022392|NCT00762788|B2|Baseline|Lotrafilcon A Contact Lens|NIGHT&DAY
1022393|NCT00762788|B1|Baseline|Senofilcon A Contact Lens|ACUVUE OASYS
1022394|NCT00762788|P6|Participant Flow|Etafilcon A Contact Lens|ACUVUE 2
1022395|NCT00762788|P5|Participant Flow|Comfilcon A Contact Lens|Biofinity
1022396|NCT00762788|P4|Participant Flow|Balafilcon A Contact Lens|PureVision
1022397|NCT00762788|P3|Participant Flow|Lotrafilcon B Contact Lens|O2Optix
1022398|NCT00762788|P2|Participant Flow|Lotrafilcon A Contact Lens|NIGHT&DAY
1022399|NCT00762788|P1|Participant Flow|Senofilcon A Contact Lens|ACUVUE OASYS
1022400|NCT00762788|O6|Outcome|Etafilcon A Contact Lens|ACUVUE 2
1022401|NCT00762788|O5|Outcome|Comfilcon A Contact Lens|Biofinity
1022402|NCT00762788|O4|Outcome|Balafilcon A Contact Lens|PureVision
1022403|NCT00762788|O3|Outcome|Lotrafilcon B Contact Lens|O2Optix
1022404|NCT00762788|O2|Outcome|Lotrafilcon A Contact Lens|NIGHT&DAY
1022405|NCT00762788|O1|Outcome|Senofilcon A Contact Lens|ACUVUE OASYS
1022417|NCT00762788|E1|Reported Event|Senofilcon A Contact Lens|ACUVUE OASYS
1022418|NCT00762762|B3|Baseline|Total|Total of all reporting groups
1022419|NCT00762762|B2|Baseline|Placebo Comparator|Anti-cavity, fluoride oral rinse
1022420|NCT00762762|B1|Baseline|Active Comparator|triclosan/fluoride/copolymer toothpaste
1022421|NCT00762762|P2|Participant Flow|Placebo Comparator|Anti-cavity, fluoride oral rinse
1022422|NCT00762762|P1|Participant Flow|Active Comparator|triclosan/fluoride/copolymer toothpaste
1022423|NCT00762762|O2|Outcome|Placebo Comparator|Anti-cavity, fluoride oral rinse
1022424|NCT00762762|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
1022425|NCT00762762|O2|Outcome|Placebo Comparator|Anti-cavity, fluoride oral rinse
1022426|NCT00762762|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
1022427|NCT00762762|O2|Outcome|Placebo Comparator|Anti-cavity, fluoride oral rinse
1022428|NCT00762762|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
1022429|NCT00762762|O2|Outcome|Placebo Comparator|Anti-cavity, fluoride oral rinse
1022430|NCT00762762|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
1022431|NCT00762762|O2|Outcome|Placebo Comparator|Anti-cavity, fluoride oral rinse
1022432|NCT00762762|O1|Outcome|Active Comparator|triclosan/fluoride/copolymer toothpaste
1022433|NCT00762762|E2|Reported Event|Placebo Comparator|Anti-cavity, fluoride oral rinse
1022434|NCT00762762|E1|Reported Event|Active Comparator|triclosan/fluoride/copolymer toothpaste
1022435|NCT00762723|B4|Baseline|Total|Total of all reporting groups
1022436|NCT00762723|B3|Baseline|Group 3|"Trinica Anterior Lumbar Plate with hybrid screw configuration (2 fixed-angle screws with 2 variable-angle screws).~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
1022437|NCT00762723|B2|Baseline|Group 2|"Trinica Anterior Lumbar Plate System with variable screws only~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
1022438|NCT00762723|B1|Baseline|Group 1|"Trinica Anterior Lumbar Plate System with fixed screws only~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
1022439|NCT00762723|P3|Participant Flow|ALP With Hybrid Screws|"Trinica Anterior Lumbar Plate with hybrid screw configuration (2 fixed-angle screws with 2 variable-angle screws).~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
1022440|NCT00762723|P2|Participant Flow|ALP With Variable Screws|"Trinica Anterior Lumbar Plate System with variable screws only~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
1022441|NCT00762723|P1|Participant Flow|ALP With Fixed Screws|"Trinica Anterior Lumbar Plate System with fixed screws only~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
1022442|NCT00762723|O3|Outcome|Group 3|"Trinica Anterior Lumbar Plate with hybrid screw configuration (2 fixed-angle screws with 2 variable-angle screws).~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
1022443|NCT00762723|O2|Outcome|Group 2|"Trinica Anterior Lumbar Plate System with variable screws only~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
1022444|NCT00762723|O1|Outcome|Group 1|"Trinica Anterior Lumbar Plate System with fixed screws only~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
1022445|NCT00762723|E3|Reported Event|Group 3|"Trinica Anterior Lumbar Plate with hybrid screw configuration (2 fixed-angle screws with 2 variable-angle screws).~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
1022446|NCT00762723|E2|Reported Event|Group 2|"Trinica Anterior Lumbar Plate System with variable screws only~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
1022512|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022447|NCT00762723|E1|Reported Event|Group 1|"Trinica Anterior Lumbar Plate System with fixed screws only~Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration."
1022448|NCT00762645|B3|Baseline|Total|Total of all reporting groups
1022449|NCT00762645|B2|Baseline|Pilocarpine 1%|Pilocarpine 1% Ophthalmic Solution
1022450|NCT00762645|B1|Baseline|Travoprost 0.004% (Travatan)|Travoprost 0.004% Ophthalmic Solution
1022451|NCT00762645|P2|Participant Flow|Pilocarpine 1%|Pilocarpine 1% Ophthalmic Solution
1022452|NCT00762645|P1|Participant Flow|Travoprost 0.004% (Travatan)|Travoprost 0.004% Ophthalmic Solution
1022453|NCT00762645|O2|Outcome|Pilocarpine 1%|Pilocarpine 1% Ophthalmic Solution
1022454|NCT00762645|O1|Outcome|Travoprost 0.004% (Travatan)|Travoprost 0.004% Ophthalmic Solution
1022455|NCT00762645|O2|Outcome|Pilocarpine 1%|Pilocarpine 1% Ophthalmic Solution
1022456|NCT00762645|O1|Outcome|Travoprost 0.004% (Travatan)|Travoprost 0.004% Ophthalmic Solution
1022457|NCT00762645|E2|Reported Event|Pilocarpine 1%|Pilocarpine 1% Ophthalmic Solution
1022458|NCT00762645|E1|Reported Event|Travoprost 0.004% (Travatan)|Travoprost 0.004% Ophthalmic Solution
1022459|NCT00762619|B3|Baseline|Total|Total of all reporting groups
1022460|NCT00762619|B2|Baseline|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
1022461|NCT00762619|B1|Baseline|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
1022462|NCT00762619|P2|Participant Flow|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
1022463|NCT00762619|P1|Participant Flow|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
1022464|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022465|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022466|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022467|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022468|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022469|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022470|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022471|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022472|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022473|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022474|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022475|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022476|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022477|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022478|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022479|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022480|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022481|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022482|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022483|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022484|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022485|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022486|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022487|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022488|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022489|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022490|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022491|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022492|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022493|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022494|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022495|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022496|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022497|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022498|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022499|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022500|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022501|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022502|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022503|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022504|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022505|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022506|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022507|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022508|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022509|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022510|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022511|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022513|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022514|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022515|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022516|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022517|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022518|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022519|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022520|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022521|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022522|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022523|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022524|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022525|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022526|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022527|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022528|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022529|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022530|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022531|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022532|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022533|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022534|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022535|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022536|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022537|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022538|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022539|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022540|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022541|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022542|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022543|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022544|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022545|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022546|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022547|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022548|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022549|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022550|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022551|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022552|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022553|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022554|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022555|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022556|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022557|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022558|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022559|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022560|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022561|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022562|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022563|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022564|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022565|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022566|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022567|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022568|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022569|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022570|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022571|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022572|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022573|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022574|NCT00762619|O2|Outcome|B - Positive Control|fluoride/triclosan/copolymer toothpaste
1022575|NCT00762619|O1|Outcome|A - Fluoride Only Control|Fluoride only (Ultrabrite)
1022576|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
1022577|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
1022578|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
1022579|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
1022580|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
1022581|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
1022582|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
1022583|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
1022584|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
1022585|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
1022586|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
1022587|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
1022588|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
1022589|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
1022590|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
1022591|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
1022592|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
1022593|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
1022594|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
1022595|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
1022596|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
1022597|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
1022598|NCT00762619|O2|Outcome|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
1022599|NCT00762619|O1|Outcome|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
1022600|NCT00762619|E2|Reported Event|B - Postive Control|fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
1022601|NCT00762619|E1|Reported Event|A - Fluoride Control|Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
1022602|NCT00762606|B3|Baseline|Total|Total of all reporting groups
1022603|NCT00762606|B2|Baseline|SICS|Small incision cataract surgery (SICS)
1022604|NCT00762606|B1|Baseline|Phaco|cataract extraction surgery utilizing Phacoemulsification
1022605|NCT00762606|P2|Participant Flow|SICS|Small incision cataract surgery (SICS)
1022606|NCT00762606|P1|Participant Flow|Phaco|cataract extraction surgery utilizing Phacoemulsification
1022607|NCT00762606|O2|Outcome|SICS|Small incision cataract surgery (SICS)
1022608|NCT00762606|O1|Outcome|Phaco|cataract extraction surgery utilizing Phacoemulsification
1022609|NCT00762606|O2|Outcome|SICS|Small incision cataract surgery (SICS)
1022610|NCT00762606|O1|Outcome|Phaco|cataract extraction surgery utilizing Phacoemulsification
1022611|NCT00762606|E2|Reported Event|SICS|Small incision cataract surgery (SICS)
1022612|NCT00762606|E1|Reported Event|Phaco|cataract extraction surgery utilizing Phacoemulsification
1022613|NCT00762528|B3|Baseline|Total|Total of all reporting groups
1022614|NCT00762528|B2|Baseline|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
1022615|NCT00762528|B1|Baseline|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
1022616|NCT00762528|P2|Participant Flow|Fluoride Toothpaste|Sodium monofluorophosphate toothpaste
1022617|NCT00762528|P1|Participant Flow|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
1022618|NCT00762528|O2|Outcome|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
1022619|NCT00762528|O1|Outcome|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
1022620|NCT00762528|O2|Outcome|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
1022621|NCT00762528|O1|Outcome|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
1022622|NCT00762528|O2|Outcome|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
1022623|NCT00762528|O1|Outcome|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
1022624|NCT00762528|O2|Outcome|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
1022625|NCT00762528|O1|Outcome|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
1022626|NCT00762528|O2|Outcome|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
1022627|NCT00762528|O1|Outcome|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
1022628|NCT00762528|O2|Outcome|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
1022629|NCT00762528|O1|Outcome|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
1022630|NCT00762528|O2|Outcome|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
1022631|NCT00762528|O1|Outcome|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
1022632|NCT00762528|O2|Outcome|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
1022633|NCT00762528|O1|Outcome|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
1022675|NCT00762476|E2|Reported Event|3804-250A|Experimental AV Lotion
1022634|NCT00762528|E2|Reported Event|Fluoride Toothpaste|sodium monofluorophosphate toothpaste
1022635|NCT00762528|E1|Reported Event|Total Toothpaste|Triclosan/Copolymer/fluoride toothpaste
1022636|NCT00762515|B3|Baseline|Total|Total of all reporting groups
1022637|NCT00762515|B2|Baseline|B- Active Comparator|Fluoride/triclosan toothpaste (Total)
1022638|NCT00762515|B1|Baseline|A -Placebo Comparator|Fluoride toothpaste
1022639|NCT00762515|P2|Participant Flow|B- Active Comparator|Fluoride/triclosan toothpaste (Total)
1022640|NCT00762515|P1|Participant Flow|A -Placebo Comparator|Fluoride toothpaste
1022641|NCT00762515|O2|Outcome|B- Active Comparator|Fluoride/triclosan toothpaste (Total)
1022642|NCT00762515|O1|Outcome|A -Placebo Comparator|Fluoride toothpaste
1022643|NCT00762515|O2|Outcome|B- Active Comparator|Fluoride/triclosan toothpaste (Total)
1022644|NCT00762515|O1|Outcome|A -Placebo Comparator|Fluoride toothpaste
1022645|NCT00762515|E2|Reported Event|B- Active Comparator|Fluoride/triclosan toothpaste (Total)
1022646|NCT00762515|E1|Reported Event|A -Placebo Comparator|Fluoride toothpaste
1022647|NCT00762502|B4|Baseline|Total|Total of all reporting groups
1022648|NCT00762502|B3|Baseline|Senofilcon A/Balafilcon A Contralaterally|senofilcon A lens worn in one eye and balafilcon A lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly.
1022649|NCT00762502|B2|Baseline|Balafilcon A Toric Bilaterally|balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.
1022650|NCT00762502|B1|Baseline|Senofilcon A Toric Bilaterally|senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.
1022651|NCT00762502|P3|Participant Flow|Senofilcon A Toric/Balafilcon A Toric Contralaterally|Senofilcon A toric lens worn in one eye and Balafilcon A toric lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly. For those subject who continued the study from 3 months to 6 months, the same treatment was repeated.
1022652|NCT00762502|P2|Participant Flow|Balafilcon A Bilaterally|Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. For those subject who continued the study from 3 months to 6 months, the same treatment was repeated.
1022653|NCT00762502|P1|Participant Flow|Senofilcon A Bilaterally|Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. For those subject who continued the study from 3 months to 6 months, the same treatment was repeated.
1022654|NCT00762502|O2|Outcome|Balafilcon A|Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly OR Balafilcon A Toric worn contralaterally , replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
1022655|NCT00762502|O1|Outcome|Senofilcon A|Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. OR Senofilcon A Toric worn contralaterally, replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
1022656|NCT00762502|O2|Outcome|Balafilcon A|Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly OR Balafilcon A Toric worn contralaterally , replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
1022657|NCT00762502|O1|Outcome|Senofilcon A|Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. OR Senofilcon A Toric worn contralaterally, replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
1022658|NCT00762502|O2|Outcome|Balafilcon A|Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly OR Balafilcon A Toric worn contralaterally , replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
1022659|NCT00762502|O1|Outcome|Senofilcon A|Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. OR Senofilcon A Toric worn contralaterally, replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
1022660|NCT00762502|O2|Outcome|Balafilcon A|Balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly OR Balafilcon A Toric worn contralaterally , replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
1022661|NCT00762502|O1|Outcome|Senofilcon A|Senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly. OR Senofilcon A Toric worn contralaterally, replaced weekly. (Due to the randomization and large number of non-completed it is possible that the contralateral subjects are not equally split between the devices.)
1022662|NCT00762502|E2|Reported Event|Balafilcon A|balafilcon A lenses (control) worn daily bilaterally (in both eyes) for 6months, replaced weekly OR balifilcon A toric lenses worn contralaterally for 6 months, replaced weekly. All enrolled subjects are included. Subjects are counted by device, there are some subjects that are counted in both arms that are from the contralateral group, as identified in the participant flow.
1022663|NCT00762502|E1|Reported Event|Senofilcon A|senofilcon A lenses (test) worn daily bilaterally (in both eyes) for 6 months, replaced weekly OR senofilcon A toric lenses worn contralaterally for 6 months, replaced weekly. All enrolled subjects are included. Subjects are counted by device, there are some subjects that are counted in both arms that are from the contralateral group, as identified in the participant flow.
1022664|NCT00762476|B3|Baseline|Total|Total of all reporting groups
1022665|NCT00762476|B2|Baseline|3804-250A|Experimental AV Lotion
1022666|NCT00762476|B1|Baseline|Placebo|Modified AV Lotion without active ingredients.
1022667|NCT00762476|P2|Participant Flow|3804-250A|Experimental AV Lotion
1022668|NCT00762476|P1|Participant Flow|Placebo|Modified AV Lotion without active ingredients.
1022669|NCT00762476|O2|Outcome|3804-250A|Experimental AV Lotion
1022670|NCT00762476|O1|Outcome|Placebo|Modified AV Lotion without active ingredients.
1022671|NCT00762476|O2|Outcome|3804-250A|Experimental AV Lotion
1022672|NCT00762476|O1|Outcome|Placebo|Modified AV Lotion without active ingredients.
1022673|NCT00762476|O2|Outcome|3804-250A|Experimental AV Lotion
1022674|NCT00762476|O1|Outcome|Placebo|Modified AV Lotion without active ingredients
1022676|NCT00762476|E1|Reported Event|Placebo|Modified AV Lotion without active ingredients.
1022677|NCT00762463|B3|Baseline|Total|Total of all reporting groups
1022678|NCT00762463|B2|Baseline|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
1022679|NCT00762463|B1|Baseline|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
1022680|NCT00762463|P4|Participant Flow|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
1022681|NCT00762463|P3|Participant Flow|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
1022682|NCT00762463|P2|Participant Flow|Diclofenac SR 75 mg|Diclofenac sustained release (SR) 75 mg tablet once daily
1022683|NCT00762463|P1|Participant Flow|Celecoxib 200 mg|Celecoxib 200 milligram (mg) capsule once daily
1022684|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
1022685|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
1022686|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
1022687|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
1022688|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
1022689|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
1022690|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
1022691|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
1022692|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
1022693|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
1022694|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
1022695|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
1022696|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
1022697|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
1022698|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
1022699|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
1022700|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
1022701|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
1022702|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
1022703|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
1022704|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
1022705|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
1022706|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
1022707|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
1022708|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
1022709|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
1022710|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
1022711|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
1022712|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
1022713|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
1022714|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
1022715|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
1022716|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
1022717|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
1022718|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
1022719|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
1022720|NCT00762463|O4|Outcome|Diclofenac 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 and Celecoxib 400 mg once daily from Week 6 to Week 12
1022721|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
1022722|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
1022723|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
1022724|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
1022725|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
1022726|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
1022727|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
1022728|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
1022729|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
1022730|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
1022731|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
1022732|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
1022733|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
1022734|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
1022735|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
1022736|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
1022737|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
1022738|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
1022739|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
1022740|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
1022741|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
1022742|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
1022743|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
1022744|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
1022745|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
1022746|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
1022747|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
1022748|NCT00762463|O4|Outcome|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
1022749|NCT00762463|O3|Outcome|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6 followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
1022750|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
1022751|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
1022752|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
1022753|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
1022754|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
1022755|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
1022756|NCT00762463|O2|Outcome|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily
1022757|NCT00762463|O1|Outcome|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily
1022758|NCT00762463|E6|Reported Event|Diclofenac SR 75 mg, Then Celecoxib 400 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6, followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
1022759|NCT00762463|E5|Reported Event|Celecoxib 200 mg, Then Celecoxib 400 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6, followed by Celecoxib 400 mg capsules once daily from Week 6 to Week 12
1022760|NCT00762463|E4|Reported Event|Diclofenac SR 75 mg, Then Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6 followed by Diclofenac SR 75 mg tablet once daily from Week 6 to Week 12
1022761|NCT00762463|E3|Reported Event|Celecoxib 200 mg, Then Celecoxib 200 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6, followed by Celecoxib 200 mg capsule once daily from Week 6 to Week 12
1022762|NCT00762463|E2|Reported Event|Diclofenac SR 75 mg|Diclofenac SR 75 mg tablet once daily from baseline to Week 6
1022763|NCT00762463|E1|Reported Event|Celecoxib 200 mg|Celecoxib 200 mg capsule once daily from baseline to Week 6
1022764|NCT00762450|B4|Baseline|Total|Total of all reporting groups
1022765|NCT00762450|B3|Baseline|Experimental First, Placebo Second and Positive Control Last|
1022766|NCT00762450|B2|Baseline|Positive Control First, Experimental Second and Placebo Last|
1022767|NCT00762450|B1|Baseline|Placebo First, Positive Control Second and Experimental Last|
1022768|NCT00762450|P3|Participant Flow|Experimental 1st, Placebo 2nd and Active Comparator Last|Order of study treatment toothpastes for the enrolled panelist placed in that treatment group. All panelists brushed their teeth with all study treatments, just the order of appearance changed. All panelists rinsed their mouths with a slurry of the assigned toothpaste three times a day for 7 days.
1022769|NCT00762450|P2|Participant Flow|Active Comparator 1st, Experimental 2nd and Placebo Last|Order of study treatment toothpastes for the enrolled panelist placed in that treatment group. All panelists brushed their teeth with all study treatments, just the order of appearance changed. All panelists rinsed their mouths with a slurry of the assigned toothpaste three times a day for 7 days.
1022770|NCT00762450|P1|Participant Flow|Placebo 1st, Active Comparator 2nd and Experimental Last|Order of study treatment toothpastes for the enrolled panelist placed in that treatment group. All panelists brushed their teeth with all study treatments, just the order of appearance changed. All panelists rinsed their mouths with a slurry of the assigned toothpaste three times a day for 7 days.
1022771|NCT00762450|O3|Outcome|Experimental Toothpaste|
1022772|NCT00762450|O2|Outcome|Placebo - Silica Control|
1022773|NCT00762450|O1|Outcome|Active Comparator|
1022774|NCT00762450|E3|Reported Event|Experimental First, Placebo Second and Positive Control Last|
1022775|NCT00762450|E2|Reported Event|Positive Control First, Experimental Second and Placebo Last|
1022776|NCT00762450|E1|Reported Event|Placebo First, Positive Control Second and Experimental Last|
1022777|NCT00762424|B3|Baseline|Total|Total of all reporting groups
1022778|NCT00762424|B2|Baseline|Placebo|placebo: cornstarch
1022779|NCT00762424|B1|Baseline|Tamsulosin|Flowmax: 0.4 mg once a day until stone passage total = 9 tablets
1022781|NCT00762424|P1|Participant Flow|Tamsulosin|Flowmax: 0.4 mg once a day until stone passage total = 9 tablets
1022782|NCT00762424|O2|Outcome|Placebo|placebo: cornstarch
1022783|NCT00762424|O1|Outcome|Tamsulosin|Flowmax: 0.4 mg once a day until stone passage total = 9 tablets
1022784|NCT00762424|E2|Reported Event|Placebo|placebo: cornstarch
1022785|NCT00762424|E1|Reported Event|Tamsulosin|Flowmax: 0.4 mg once a day until stone passage total = 9 tablets
1022786|NCT00762411|B3|Baseline|Total|Total of all reporting groups
1022787|NCT00762411|B2|Baseline|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
1022788|NCT00762411|B1|Baseline|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1022789|NCT00762411|P2|Participant Flow|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
1022790|NCT00762411|P1|Participant Flow|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1022791|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
1022792|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1022793|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
1022794|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1022795|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
1022796|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1022797|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
1022798|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1022799|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
1022800|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1022801|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
1022802|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1022803|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
1022804|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1022805|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
1022806|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1022807|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
1022808|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1022809|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
1022810|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1022811|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
1022812|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1022813|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
1022814|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1022815|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1022816|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1022817|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
1022818|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1022819|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
1022820|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1022821|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
1022822|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1022823|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
1022824|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1022825|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
1022826|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1022827|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
1022828|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1022829|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
1022830|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1022831|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
1022832|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1022833|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
1022834|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1022835|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
1022836|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1022837|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
1022838|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1022839|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
1022840|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1022841|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
1022842|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1022843|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
1022844|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1022884|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022845|NCT00762411|O2|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, participants in the placebo arm received LY450139 titrated up to 140 mg orally once daily until Week 88.
1022846|NCT00762411|O1|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1022847|NCT00762411|E6|Reported Event|140 mg LY450139 - SFU|For SFU, study drug had been stopped and period was optional to enter; Participants entered from 140 mg LY450139 initial treatment or delayed start or did not enter SFU.
1022848|NCT00762411|E5|Reported Event|Placebo-Safety Follow Up Period (SFU)|For SFU, study drug had been stopped and period was optional to enter; Participants entered from Placebo initial treatment or delayed start or did not enter SFU.
1022849|NCT00762411|E4|Reported Event|140 mg LY450139- DO|After Week 76, participants received 140 mg LY450139 orally once daily until Week 88.
1022850|NCT00762411|E3|Reported Event|Placebo- (Delayed Start Period [DO])|After Week 76, participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1022851|NCT00762411|E2|Reported Event|140 mg LY450139- NT|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 76.
1022852|NCT00762411|E1|Reported Event|Placebo- (Initial Treatment Period [NT])|Participants received placebo orally once daily for the first 76 weeks.
1022853|NCT00762385|B1|Baseline|Completed Population|Includes subjects randomized to galyfilcon A/comfilcon A and comfilcon A/galyfilcon A and that completed the study.
1022854|NCT00762385|P2|Participant Flow|Comfilcon A / Galyfilcon A|comfilcon A contact lenses first period, galyfilcon A contact lenses second period
1022855|NCT00762385|P1|Participant Flow|Galyfilcon A / Comfilcon A|galyfilcon A contact lenses first period, comfilcon a contact lenses second period
1022856|NCT00762385|O2|Outcome|Comfilcon A|comfilcon A administered in either the first intervention period or the second intervention period.
1022857|NCT00762385|O1|Outcome|Galyfilcon A|galyfilcon A administered in either the first intervention period or the second intervention period.
1022858|NCT00762385|O2|Outcome|Comfilcon A|
1022859|NCT00762385|O1|Outcome|Galyfilcon A|
1022860|NCT00762385|O2|Outcome|Comfilcon A|comfilcon A administered in either the first intervention period or second intervention period.
1022861|NCT00762385|O1|Outcome|Galyfilcon A|galyfilcon A administered in either the first intervention period or the second intervention period.
1022862|NCT00762385|E2|Reported Event|Comfilcon A / Galyfilcon A|comfilcon A contact lenses first period, galyfilcon A contact lenses second period
1022863|NCT00762385|E1|Reported Event|Galyfilcon A / Comfilcon A|galyfilcon A contact lenses first period, comfilcon a contact lenses second period
1022864|NCT00762359|B3|Baseline|Total|Total of all reporting groups
1022865|NCT00762359|B2|Baseline|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022866|NCT00762359|B1|Baseline|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022867|NCT00762359|P2|Participant Flow|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022868|NCT00762359|P1|Participant Flow|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022869|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022870|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022871|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022872|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022873|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022874|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022875|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022876|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022877|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022878|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022879|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022880|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022881|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022882|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022883|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022999|NCT00762229|O1|Outcome|Ezetimibe 10 mg|A whole ezetimibe 10 mg tablet
1022885|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022886|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022887|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022888|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022889|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022890|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022891|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022892|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022893|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022894|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022895|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022896|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022897|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022898|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022899|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022900|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022901|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022902|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022903|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022904|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022905|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022906|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022907|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022908|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022909|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022910|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022911|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022912|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022913|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022914|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022915|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022916|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022917|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022918|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022919|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022920|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022921|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022922|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022923|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022924|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022925|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022926|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022927|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022928|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022929|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022930|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022931|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022932|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022933|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022934|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022935|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022936|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022937|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022938|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022939|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022940|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022941|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022942|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022943|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022944|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022945|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022946|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022947|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022948|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022949|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022950|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022951|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022952|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022953|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022954|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022955|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022956|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022957|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022958|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022959|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022960|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022961|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022962|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022963|NCT00762359|O2|Outcome|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022964|NCT00762359|O1|Outcome|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022965|NCT00762359|E2|Reported Event|Gefarnate 50 mg BID|Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
1022966|NCT00762359|E1|Reported Event|Lansoprazole 15 mg QD|Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
1022967|NCT00762320|B1|Baseline|Low Dose Kaletra|"Patients will serve as their own controls as they are switched from liquid Kaletra to Low Dose Tablet Kaletra~Low dose Kaletra tablets : Lopinavir/Ritonavir tablets 100mg/25mg"
1022968|NCT00762320|P1|Participant Flow|Low Dose Kaletra|"Patients will serve as their own controls as they are switched from liquid Kaletra to Low Dose Tablet Kaletra~Low dose Kaletra tablets : Lopinavir/Ritonavir tablets 100mg/25mg"
1022969|NCT00762320|O2|Outcome|Low Dose Kaletra Week 4|Patients Receiving Low Dose Kaletra at Week 4
1022970|NCT00762320|O1|Outcome|Low Dose Kaletra Baseline|Patients receiving Low Dose Kaletra at baseline
1022971|NCT00762320|O1|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra Tablets
1022972|NCT00762320|O1|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra Tablets
1022973|NCT00762320|O1|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra Tablets
1022974|NCT00762320|O1|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra
1022975|NCT00762320|O2|Outcome|Low Dose Kaletra Week 4 Visit|Patient Satisfaction Score at Week 4 visit
1022976|NCT00762320|O1|Outcome|Low Dose Kaletra Baseline Visit|Patient satisfaction score at baseline visit
1022977|NCT00762320|O1|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra Tablets
1022978|NCT00762320|O1|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra Tablets
1022979|NCT00762320|O1|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra Tablets
1022980|NCT00762320|O1|Outcome|Low Dose Kaletra|Patients receiving Low Dose Kaletra Tablets
1022981|NCT00762320|E1|Reported Event|Low Dose Kaletra|"Patients will serve as their own controls as they are switched from liquid Kaletra to Low Dose Tablet Kaletra~Low dose Kaletra tablets : Lopinavir/Ritonavir tablets 100mg/25mg"
1022982|NCT00762268|B3|Baseline|Total|Total of all reporting groups
1022983|NCT00762268|B2|Baseline|Placebo|"Placebo: Placebo SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral pills for only 3 days per week, followed by a 4 day rest-period, before the round. The apparent dosage will be progressively increased each week to mimic a maximum of 1600 mg per day over a 4-week period."
1022984|NCT00762268|B1|Baseline|SAMe|"SAMe: SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day rest-period, before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period."
1022985|NCT00762268|P2|Participant Flow|Placebo|"Placebo: Placebo SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral pills for only 3 days per week, followed by a 4 day rest-period, before the round. The apparent dosage will be progressively increased each week to mimic a maximum of 1600 mg per day over a 4-week period."
1022986|NCT00762268|P1|Participant Flow|SAMe|"SAMe: SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day rest-period, before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period."
1022987|NCT00762268|O2|Outcome|Placebo|"Placebo: Placebo SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral pills for only 3 days per week, followed by a 4 day rest-period, before the round. The apparent dosage will be progressively increased each week to mimic a maximum of 1600 mg per day over a 4-week period."
1022988|NCT00762268|O1|Outcome|SAMe|"SAMe: SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day rest-period, before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period."
1022989|NCT00762268|E2|Reported Event|Placebo|"Placebo: Placebo SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral pills for only 3 days per week, followed by a 4 day rest-period, before the round. The apparent dosage will be progressively increased each week to mimic a maximum of 1600 mg per day over a 4-week period."
1022990|NCT00762268|E1|Reported Event|SAMe|"SAMe: SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day rest-period, before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period."
1022991|NCT00762229|B3|Baseline|Total|Total of all reporting groups
1022992|NCT00762229|B2|Baseline|Ezetimibe 5 mg|Ezetimibe 5 mg,
1022993|NCT00762229|B1|Baseline|Ezetimibe 10 mg|A whole ezetimibe 10 mg tablet
1022994|NCT00762229|P2|Participant Flow|Ezetimibe 5 mg|Ezetimibe 5 mg,
1022995|NCT00762229|P1|Participant Flow|Ezetimibe 10 mg|A whole ezetimibe 10 mg tablet
1022996|NCT00762229|O2|Outcome|Ezetimibe 5 mg|Ezetimibe 5 mg,
1022997|NCT00762229|O1|Outcome|Ezetimibe 10 mg|A whole ezetimibe 10 mg tablet
1022998|NCT00762229|O2|Outcome|Ezetimibe 5 mg|Ezetimibe 5 mg,
1023001|NCT00762229|E1|Reported Event|Ezetimibe 10 mg|A whole ezetimibe 10 mg tablet
1023002|NCT00762216|B1|Baseline|Toric|Implantation with the AcrySof® Toric intraocular lens
1023003|NCT00762216|P1|Participant Flow|Toric|Implantation with the AcrySof® Toric intraocular lens
1023004|NCT00762216|O1|Outcome|Toric|Implantation with the AcrySof® Toric intraocular lens
1023005|NCT00762216|O1|Outcome|Toric|Implantation with the AcrySof® Toric intraocular lens
1023006|NCT00762216|E1|Reported Event|Toric|Implantation with the AcrySof® Toric intraocular lens
1023007|NCT00762177|B4|Baseline|Total|Total of all reporting groups
1023008|NCT00762177|B3|Baseline|Experimental 1st, Placebo 2nd, Active Comparator 3rd|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste) during the first intervention, then brushed with the placebo control (fluoride toothpaste only) during the second intervention and Active Comparator(fluoride/triclosan/copolymer toothpaste)as the last intervention.
1023009|NCT00762177|B2|Baseline|Active Comparator 1st, Experimental 2nd, Placebo 3rd|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste)during the first intervention, then brushed with experimental product (stannous fluoride toothpaste) during the second intervention, and brushed with the placebo control (fluoride toothpaste only)as the last intervention.
1023010|NCT00762177|B1|Baseline|Placebo 1st, Active Comparator 2nd and Experimental 3rd|Participants brushed their teeth with the placebo control (fluoride toothpaste only)during the first intervention then brushed with active comparator(fluoride/triclosan/copolymer toothpaste) during the second intervention and experimental product (stannous fluoride toothpaste) during as the last intervention.
1023011|NCT00762177|P3|Participant Flow|Experimental 1st, Placebo 2nd, Active Comparator 3rd|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste) during the first intervention, then brushed with the placebo control (fluoride toothpaste only) during the second intervention and Active Comparator(fluoride/triclosan/copolymer toothpaste)as the last intervention.
1023012|NCT00762177|P2|Participant Flow|Active Comparator 1st, Experimental 2nd, Placebo 3rd|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste)during the first intervention, then brushed with experimental product (stannous fluoride toothpaste) during the second intervention, and brushed with the placebo control (fluoride toothpaste only)as the last intervention.
1023013|NCT00762177|P1|Participant Flow|Placebo 1st, Active Comparator 2nd and Experimental 3rd|Participants brushed their teeth with the placebo control (fluoride toothpaste only)during the first intervention then brushed with active comparator(fluoride/triclosan/copolymer toothpaste) during the second intervention and experimental product (stannous fluoride toothpaste) during as the last intervention.
1023014|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
1023015|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
1023016|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
1023017|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
1023018|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
1023019|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
1023020|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
1023021|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
1023022|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
1023023|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
1023024|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
1023025|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
1023026|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
1023027|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
1023028|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
1023029|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
1023030|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
1023031|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
1023032|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
1023033|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
1023034|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
1023035|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
1023036|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
1023037|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
1023038|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
1023039|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
1023040|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
1023041|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
1023042|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
1023043|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
1023044|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
1023045|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
1023046|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
1023047|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
1023048|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
1023049|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
1023050|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
1023051|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
1023052|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
1023053|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
1023054|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
1023055|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
1023056|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
1023057|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
1023058|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
1023059|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
1023060|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
1023061|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
1023062|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
1023063|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
1023064|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
1023065|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
1023066|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
1023067|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
1023068|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
1023069|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
1023070|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
1023071|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
1023072|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
1023073|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
1023074|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
1023075|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
1023076|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
1023077|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
1023078|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
1023079|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
1023080|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
1023081|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
1023082|NCT00762177|O1|Outcome|Placebo|Participants brushed their teeth with the placebo control (fluoride toothpaste only)
1023083|NCT00762177|O3|Outcome|Experimental|Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
1023084|NCT00762177|O2|Outcome|Active Comparator|Participants brushed their teeth with the Active Comparator(fluoride/triclosan/copolymer toothpaste).
1023085|NCT00762177|O1|Outcome|Placebo Toothpaste|Participants brushed their teeth with the placebo control (fluoride toothpaste only).
1023086|NCT00762177|E3|Reported Event|Experimental|Experimental test product (stannous fluoride toothpaste)
1023087|NCT00762177|E2|Reported Event|Active Comparator|Active Comparator toothpaste containing fluoride/triclosan/copolymer (Total)
1023088|NCT00762177|E1|Reported Event|Placebo - Fluoride Control|Fluoride only toothpaste (Crest Anti-Cavity)
1023089|NCT00762164|B3|Baseline|Total|Total of all reporting groups
1023090|NCT00762164|B2|Baseline|Simvastatin|Simvastatin 20 milligrams
1023091|NCT00762164|B1|Baseline|1Vytorin 10/80 Divided Into 4|Vytorin 10/80 divided into 4
1023092|NCT00762164|P2|Participant Flow|Simvastatin|Simvastatin 20 milligrams
1023093|NCT00762164|P1|Participant Flow|1Vytorin 10/80 Divided Into 4|Vytorin 10/80 divided into 4
1023094|NCT00762164|O2|Outcome|Simvastatin|Simvastatin 20 milligrams
1023095|NCT00762164|O1|Outcome|1Vytorin 10/80 Divided Into 4|Vytorin 10/80 divided into 4
1023096|NCT00762164|O2|Outcome|Simvastatin|Simvastatin 20 milligrams
1023097|NCT00762164|O1|Outcome|1Vytorin 10/80 Divided Into 4|Vytorin 10/80 divided into 4
1023098|NCT00762164|E2|Reported Event|Simvastatin|Simvastatin 20 milligrams
1023099|NCT00762164|E1|Reported Event|1Vytorin 10/80 Divided Into 4|Vytorin 10/80 divided into 4
1023100|NCT00762086|B3|Baseline|Total|Total of all reporting groups
1023101|NCT00762086|B2|Baseline|Control Group|Aspirin/Clopidegrol and Standard walking exercises
1023102|NCT00762086|B1|Baseline|Treatment Group|AngioPress IPC Device
1023103|NCT00762086|P2|Participant Flow|Control Group|Aspirin/Clopidegrol and Standard walking exercises
1023104|NCT00762086|P1|Participant Flow|Treatment Group|AngioPress IPC Device
1023105|NCT00762086|O2|Outcome|Control Group|Aspirin/Clopidegrol and Standard walking exercises
1023106|NCT00762086|O1|Outcome|Treatment Group|AngioPress IPC Device
1023107|NCT00762086|E2|Reported Event|Control Group|Aspirin/Clopidegrol and Standard walking exercises
1023108|NCT00762086|E1|Reported Event|Treatment Group|AngioPress IPC Device
1023109|NCT00762073|B5|Baseline|Total|Total of all reporting groups
1023110|NCT00762073|B4|Baseline|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
1023111|NCT00762073|B3|Baseline|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
1023112|NCT00762073|B2|Baseline|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
1023113|NCT00762073|B1|Baseline|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks with a 3 week taper period.
1023114|NCT00762073|P4|Participant Flow|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
1023115|NCT00762073|P3|Participant Flow|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
1023116|NCT00762073|P2|Participant Flow|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
1023117|NCT00762073|P1|Participant Flow|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks with a 3 week taper period.
1023118|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
1023119|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
1023120|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
1023121|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
1023122|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
1023123|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
1023124|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
1023125|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
1023126|NCT00762073|O4|Outcome|2.0 mg Dose|Participants 10 to 18 years received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and either placebo or OBS 0.2 mg/ml after breakfast (qAM, pc), with a total daily dose of 2.0 mg (medium dose group) or 4.0 mg (high dose group).
1023127|NCT00762073|O3|Outcome|1.4 mg Dose|Participants 2 to 9 years old received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and either placebo or OBS 0.2 mg/ml after breakfast (qAM, pc), with a total daily dose of 1.4 mg (medium dose group) or 2.8 mg (high dose group).
1023128|NCT00762073|O2|Outcome|0.50 mg Dose|Participants 10 to 18 years received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc), with a total daily dose of 0.50 mg.
1023129|NCT00762073|O1|Outcome|0.35 mg Dose|Participants 2 to 9 years received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc), with a total daily dose of 0.35 mg.
1023130|NCT00762073|O4|Outcome|2.0 mg Dose|Participants 10 to 18 years old received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and either placebo or OBS 0.2 mg/ml after breakfast (qAM, pc), with a total daily dose of 2.0 mg (medium dose group) or 4.0 mg (high dose group).
1025013|NCT00758420|B3|Baseline|Total|Total of all reporting groups
1023131|NCT00762073|O3|Outcome|1.4 mg Dose|Participants 2 to 9 years old received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and either placebo or OBS 0.2 mg/ml after breakfast (qAM, pc), with a total daily dose of 1.4 mg (medium dose group) or 2.8 mg (high dose group).
1023132|NCT00762073|O2|Outcome|0.50 mg Dose|Participants 10 to 18 years old received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc), with a total daily dose of 0.50 mg.
1023133|NCT00762073|O1|Outcome|0.35 mg Dose|Participants 2 to 9 years old received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc), with a total daily dose of 0.35 mg.
1023134|NCT00762073|O4|Outcome|2.0 mg Dose|Participants 10 to 18 years old received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and either placebo or OBS 0.2 mg/ml after breakfast (qAM, pc), with a total daily dose of 2.0 mg (medium dose group) or 4.0 mg (high dose group).
1023135|NCT00762073|O3|Outcome|1.4 mg Dose|Participants 2 to 9 years old received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and either placebo or OBS 0.2 mg/ml after breakfast (qAM, pc), with a total daily dose of 1.4 mg (medium dose group) or 2.8 mg (high dose group).
1023136|NCT00762073|O2|Outcome|0.50 mg Dose|Participants 10 to 18 years old received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc), with a total daily dose of 0.50 mg.
1023137|NCT00762073|O1|Outcome|0.35 mg Dose|Participants 2 to 9 years old received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc), with a total daily dose of 0.35 mg.
1023138|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
1023139|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
1023140|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
1023141|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
1023142|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
1023143|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
1023144|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
1023145|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
1023146|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
1023147|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
1023148|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
1023149|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
1023150|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
1023151|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
1023152|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
1023153|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
1023154|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
1023155|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
1023156|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
1023157|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
1023158|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
1023627|NCT00761137|O4|Outcome|Tropicamide 3 mg|Each subject randomly received blinded a thin film containing 3 mg active drug ingredient
1023159|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
1023160|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
1023161|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
1023162|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
1023163|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
1023164|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
1023165|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
1023166|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
1023167|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
1023168|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
1023169|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
1023170|NCT00762073|O4|Outcome|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 2.8 mg (2 to 9 years) or 4.0 mg (10 to 18 years), followed by a 3 week taper period.
1023171|NCT00762073|O3|Outcome|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 1.4 mg (2 to 9 years) or 2.0 mg (10 to 18 years), followed by a 3 week taper period.
1023172|NCT00762073|O2|Outcome|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks, with a total daily dose of 0.35 mg (2 to 9 years) or 0.50 mg (10 to 18 years), followed by a 3 week taper period.
1023173|NCT00762073|O1|Outcome|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks, followed by a 3 week taper period.
1023174|NCT00762073|E4|Reported Event|High Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks with a 3 week taper period.
1023175|NCT00762073|E3|Reported Event|Medium Dose|Participants received oral budesonide suspension (OBS) 0.2 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks with a 3 week taper period.
1023176|NCT00762073|E2|Reported Event|Low Dose|Participants received oral budesonide suspension (OBS) 0.05 mg/mL at bedtime (hs) and placebo after breakfast (qAM, pc) for 12 weeks with a 3 week taper period.
1023177|NCT00762073|E1|Reported Event|Placebo|Participants received placebo twice daily at bedtime (hs) and after breakfast (qAM, pc) for 12 weeks with a 3 week taper period.
1023178|NCT00762034|B3|Baseline|Total|Total of all reporting groups
1023179|NCT00762034|B2|Baseline|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023180|NCT00762034|B1|Baseline|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023181|NCT00762034|P2|Participant Flow|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023223|NCT00762034|O3|Outcome|Pac/Carbo/Bev; Induction Phase|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023182|NCT00762034|P1|Participant Flow|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023183|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023184|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023185|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023186|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023187|NCT00762034|O2|Outcome|TTF-1 Negative (H Score = 0)|"Participants who were TTF-1 Negative (H score = 0) and received either Pem/Carbo/Bev or Pac/Carbo/Bev treatment.~Pem/Carbo/Bev Treatment-500 mg per meter squared (mg/m^2) Pem IV every 21 days, plus Carbo AUC 6 IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21.~OR~Pac/Carbo/Bev Treatment-200 mg/m^2 Pac IV and AUC 6 Carbo IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21 days."
1023188|NCT00762034|O1|Outcome|TTF-1 Positive (H Score > 0)|"Participants who were TTF-1 Positive (H score > 0) and received either Pem/Carbo/Bev or Pac/Carbo/Bev treatment.~Pem/Carbo/Bev Treatment-500 mg per meter squared (mg/m^2) Pem IV every 21 days, plus Carbo AUC 6 IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21.~OR~Pac/Carbo/Bev Treatment-200 mg/m^2 Pac IV and AUC 6 Carbo IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21 days."
1023189|NCT00762034|O1|Outcome|Pem or Pac Plus Carbo/Bev|"Participants who received either Pem/Carbo/Bev or Pac/Carbo/Bev treatment.~Pem/Carbo/Bev Treatment-500 mg per meter squared (mg/m^2) Pem IV every 21 days, plus Carbo AUC 6 IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21.~OR~Pac/Carbo/Bev Treatment-200 mg/m^2 Pac IV and AUC 6 Carbo IV every 21 days for up to first 4 cycles of 21 days, plus 15 mg/kg Bev IV every 21 days."
1023190|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023191|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023192|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023298|NCT00761865|O1|Outcome|Air Cast Stirrup Brace|"50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
1023717|NCT00761007|O3|Outcome|Ibodutant 60 mg|oral tablet, once daily
1023193|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023194|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023195|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023196|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023197|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023198|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023199|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023200|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023201|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023202|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023234|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023203|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023204|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023205|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023206|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023207|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023208|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023209|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev)followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023210|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023211|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023212|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023350|NCT00761631|O6|Outcome|13vPnC Group 4|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
1023718|NCT00761007|O2|Outcome|Ibodutant 30 mg|oral tablet, once daily
1023213|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023214|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023215|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023216|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023217|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023218|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023219|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023220|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023221|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023222|NCT00762034|O4|Outcome|Pac/Carbo/Bev; Maintenance Phase|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023295|NCT00761865|P2|Participant Flow|High Tide Fracture Boot|"50 patients will be randomly assigned to the High Tide Fracture Boot.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
1023573|NCT00761202|O2|Outcome|Sodium Hyaluronate|
1023574|NCT00761202|O1|Outcome|Carboxymethylcellulose and Glycerin|
1023224|NCT00762034|O2|Outcome|Pem/Carbo/Bev; Maintenance Phase|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023225|NCT00762034|O1|Outcome|Pem/Carbo/Bev; Induction Phase|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023226|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023227|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023228|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023229|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023230|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023231|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023232|NCT00762034|O2|Outcome|Pac/Carbo/Bev|"Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023233|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023296|NCT00761865|P1|Participant Flow|Air Cast Stirrup Brace|"50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
1023235|NCT00762034|O1|Outcome|Pem/Carbo/Bev|"Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.~Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation~Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days"
1023236|NCT00762034|E2|Reported Event|Pac/Carbo/Bev|"Induction:~Paclitaxel: Induction therapy 200 milligram per meter squared (mg/m ²) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days Bevacizumab: Induction therapy 15 mg/kg IV every 21 days for up to 4 cycles of 21 days Carboplatin: Induction therapy 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days~Maintenance:~Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation."
1023237|NCT00762034|E1|Reported Event|Pem/Carbo/Bev|"Induction:~Bevacizumab: Induction therapy 15 milligrams per kilogram (mg/kg) intravenously (IV) every 21 days for up to 4 cycles of 21 days Pemetrexed: Induction therapy 500 milligram per meter squared (mg/m^2) IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days Carboplatin: Induction therapy of 6 area under the concentration curve (AUC 6) IV every 21 days for up to 4 cycles of 21 days~Maintenance:~Pemetrexed: Maintenance therapy 500 mg/m^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation Bevacizumab: Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation."
1023238|NCT00762021|B3|Baseline|Total|Total of all reporting groups
1023239|NCT00762021|B2|Baseline|SN60WF|Implantation with the AcrySof Intraocular Lens Model SN60WF
1023240|NCT00762021|B1|Baseline|SN60AT|Implantation with the AcrySof Intraocular Lens Model SN60AT
1023241|NCT00762021|P2|Participant Flow|SN60WF|Implantation with the AcrySof Intraocular Lens Model SN60WF
1023242|NCT00762021|P1|Participant Flow|SN60AT|Implantation with the AcrySof Intraocular Lens Model SN60AT
1023243|NCT00762021|O2|Outcome|SN60WF|Implantation with the AcrySof Intraocular Lens Model SN60WF
1023244|NCT00762021|O1|Outcome|SN60AT|Implantation with the AcrySof Intraocular Lens Model SN60AT
1023245|NCT00762021|O2|Outcome|SN60WF|Implantation with the AcrySof Intraocular Lens Model SN60WF
1023246|NCT00762021|O1|Outcome|SN60AT|Implantation with the AcrySof Intraocular Lens Model SN60AT
1023247|NCT00762021|O2|Outcome|SN60WF|Implantation with the AcrySof Intraocular Lens Model SN60WF
1023248|NCT00762021|O1|Outcome|SN60AT|Implantation with the AcrySof Intraocular Lens Model SN60AT
1023249|NCT00762021|E2|Reported Event|SN60WF|Implantation with the AcrySof Intraocular Lens Model SN60WF
1023250|NCT00762021|E1|Reported Event|SN60AT|Implantation with the AcrySof Intraocular Lens Model SN60AT
1023251|NCT00761969|B3|Baseline|Total|Total of all reporting groups
1023252|NCT00761969|B2|Baseline|Control|"Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
1023253|NCT00761969|B1|Baseline|Peripheral Arterial Disease|"Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =< 0.90.~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
1023254|NCT00761969|P2|Participant Flow|Control|"Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice ."
1023255|NCT00761969|P1|Participant Flow|Peripheral Arterial Disease|"Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =< 0.90.~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice ."
1023256|NCT00761969|O2|Outcome|Control|"Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
1023257|NCT00761969|O1|Outcome|Peripheral Arterial Disease|"Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =< 0.90.~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
1023297|NCT00761865|O2|Outcome|High Tide Fracture Boot|"50 patients will be randomly assigned to the High Tide Fracture Boot.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
1023575|NCT00761202|O2|Outcome|Sodium Hyaluronate|
1023258|NCT00761969|O2|Outcome|Control|"Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
1023259|NCT00761969|O1|Outcome|Peripheral Arterial Disease|"Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =< 0.90.~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
1023260|NCT00761969|E2|Reported Event|Control|"Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
1023261|NCT00761969|E1|Reported Event|Peripheral Arterial Disease|"Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =< 0.90.~Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113)."
1023262|NCT00761956|B3|Baseline|Total|Total of all reporting groups
1023263|NCT00761956|B2|Baseline|CR Standard Knee|Study arm will consist of patients that are treated with the NexGen CR Knee.
1023264|NCT00761956|B1|Baseline|CR Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.
1023265|NCT00761956|P2|Participant Flow|CR Standard Knee|Study arm will consist of patients that are treated with the NexGen CR Knee.
1023266|NCT00761956|P1|Participant Flow|CR Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.
1023267|NCT00761956|O2|Outcome|CR Standard Knee|Study arm will consist of patients that are treated with the NexGen CR Knee.
1023268|NCT00761956|O1|Outcome|CR Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.
1023269|NCT00761956|O2|Outcome|CR Standard Knee|Study arm will consist of patients that are treated with the NexGen CR Knee.
1023270|NCT00761956|O1|Outcome|CR Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.
1023271|NCT00761956|E2|Reported Event|CR Standard Knee|Study arm will consist of patients that are treated with the NexGen CR Knee.
1023272|NCT00761956|E1|Reported Event|CR Flex Fixed Bearing Knee|Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.
1023273|NCT00761930|B4|Baseline|Total|Total of all reporting groups
1023274|NCT00761930|B3|Baseline|C - Experimental Toothpaste|fluoride/herbal toothpaste
1023275|NCT00761930|B2|Baseline|B - Active Comparator|fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)
1023276|NCT00761930|B1|Baseline|A- Placebo Comparator|Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
1023277|NCT00761930|P3|Participant Flow|C - Experimental Toothpaste|fluoride/herbal toothpaste
1023278|NCT00761930|P2|Participant Flow|B - Active Comparator|fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)
1023279|NCT00761930|P1|Participant Flow|A- Placebo Comparator|Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
1023280|NCT00761930|O3|Outcome|C - Experimental Toothpaste|fluoride/herbal toothpaste
1023281|NCT00761930|O2|Outcome|B - Active Comparator|fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)
1023282|NCT00761930|O1|Outcome|A- Placebo Comparator|Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
1023283|NCT00761930|O3|Outcome|C - Experimental Toothpaste|fluoride/herbal toothpaste
1023284|NCT00761930|O2|Outcome|B - Active Comparator|fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)
1023285|NCT00761930|O1|Outcome|A- Placebo Comparator|Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
1023286|NCT00761930|O3|Outcome|C - Experimental Toothpaste|fluoride/herbal toothpaste
1023287|NCT00761930|O2|Outcome|B - Active Comparator|fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)
1023288|NCT00761930|O1|Outcome|A- Placebo Comparator|Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
1023289|NCT00761930|E3|Reported Event|C - Experimental Toothpaste|fluoride/herbal toothpaste
1023290|NCT00761930|E2|Reported Event|B - Active Comparator|fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste)
1023291|NCT00761930|E1|Reported Event|A- Placebo Comparator|Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
1023292|NCT00761865|B3|Baseline|Total|Total of all reporting groups
1023293|NCT00761865|B2|Baseline|High Tide Fracture Boot|"50 patients will be randomly assigned to the High Tide Fracture Boot.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
1023294|NCT00761865|B1|Baseline|Air Cast Stirrup Brace|"50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
1023299|NCT00761865|O2|Outcome|High Tide Fracture Boot|"50 patients will be randomly assigned to the High Tide Fracture Boot.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
1023300|NCT00761865|O1|Outcome|Air Cast Stirrup Brace|"50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
1023301|NCT00761865|E2|Reported Event|High Tide Fracture Boot|"50 patients will be randomly assigned to the High Tide Fracture Boot.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
1023302|NCT00761865|E1|Reported Event|Air Cast Stirrup Brace|"50 patients will be randomly assigned to receive the Air Cast Stirrup Brace.~Air Cast Stirrup Brace & High Tide Fracture Boot: Subjects will be randomly assigned to one of two treatment braces. All patients will be given instructions to use fracture boot or air cell brace at all times of ambulatory activity until follow-up until 2 week post-strain follow-up."
1023303|NCT00761761|B3|Baseline|Total|Total of all reporting groups
1023304|NCT00761761|B2|Baseline|Placebo|"Placebo~Placebo will be administered using random assignment at a dose of 250 mg/day, increasing to a dose of 500 mg/day by the second week and will be continued for a total of 8 weeks."
1023305|NCT00761761|B1|Baseline|Sensoril|"Sensoril(Ashwagandha)~Sensoril: Sensoril® will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
1023306|NCT00761761|P2|Participant Flow|Placebo - 2|"Placebo~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
1023307|NCT00761761|P1|Participant Flow|Sensoril Ashwagandha -1|"Sensoril(Ashwagandha)~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
1023308|NCT00761761|O2|Outcome|Placebo - 2|"Placebo~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
1023309|NCT00761761|O1|Outcome|Sensoril Ashwagandha -1|"Sensoril(Ashwagandha)~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
1023310|NCT00761761|O2|Outcome|Placebo - 2|"Placebo~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
1023311|NCT00761761|O1|Outcome|Sensoril Ashwagandha -1|"Sensoril(Ashwagandha)~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
1023312|NCT00761761|O2|Outcome|Placebo - 2|"Placebo~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
1023313|NCT00761761|O1|Outcome|Sensoril Ashwagandha -1|"Sensoril(Ashwagandha)~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
1023314|NCT00761761|O2|Outcome|Placebo|"Placebo~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
1023315|NCT00761761|O1|Outcome|Sensoril|"Sensoril(Ashwagandha)~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
1023316|NCT00761761|E2|Reported Event|Placebo|"Placebo~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
1023317|NCT00761761|E1|Reported Event|Sensoril|"Sensoril(Ashwagandha)~Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks."
1023318|NCT00761748|B1|Baseline|Overall Study Population|Urostomy operated subjects
1023319|NCT00761748|P2|Participant Flow|ConvaTec 2 Piece,First, Then Sensura Uro 2 Piece|Convatec is the reference product and was chosen because of its similarity with the Sensura appliance.
1023320|NCT00761748|P1|Participant Flow|Sensura Uro 2 Piece First, Then Convatec 2 Piece|Sensura is a newly developed two piece product for people with urostomies.
1023321|NCT00761748|O2|Outcome|Convatec 2 Piece|The reference product Convatec 2 piece is a urostomy bag intended for collecting urin from a stoma.
1023322|NCT00761748|O1|Outcome|Sensura Uro 2 Piece|The new SenSura Uro 2-piece. Is a urostomy bag with the intended use of collecting urine from a stoma. Consist of a base plate and a bag that is attached to the base plate.
1023323|NCT00761748|E2|Reported Event|Convatec 2 Piece|The reference product Convatec 2 piece is a urostomy bag intended for collecting urine from a stoma.
1023324|NCT00761748|E1|Reported Event|Sensura Uro 2 Piece|SenSura Uro 2-piece. Is a urostomy bag with the intended use of collecting urine from a stoma. Consist of a base plate and a bag that is attached to the base plate.
1023576|NCT00761202|O1|Outcome|Carboxymethylcellulose and Glycerin|
1023325|NCT00761735|B1|Baseline|PEG-IFN + RBV: LTFU|Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
1023326|NCT00761735|P1|Participant Flow|PEG-IFN + RBV: LTFU|Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
1023327|NCT00761735|O2|Outcome|PEG-IFN + RBV: LTFU (Male)|Male pediatric participants who completed treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
1023328|NCT00761735|O1|Outcome|PEG-IFN + RBV: LTFU (Female)|Female pediatric participants who completed treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
1023329|NCT00761735|O2|Outcome|PEG-IFN + RBV: LTFU (48 Weeks)|Pediatric participants who completed 48 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
1023330|NCT00761735|O1|Outcome|PEG-IFN + RBV: LTFU (24 Weeks)|Pediatric participants who completed 24 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
1023331|NCT00761735|O2|Outcome|PEG-IFN + RBV: LTFU (48 Weeks)|Pediatric participants who completed 48 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
1023332|NCT00761735|O1|Outcome|PEG-IFN + RBV: LTFU (24 Weeks)|Pediatric participants who completed 24 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
1023333|NCT00761735|O2|Outcome|PEG-IFN + RBV: LTFU (48 Weeks)|Pediatric participants who completed 48 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
1023334|NCT00761735|O1|Outcome|PEG-IFN + RBV: LTFU (24 Weeks)|Pediatric participants who completed 24 weeks of treatment with PEG-IFN plus RBV in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year LTFU during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
1023335|NCT00761735|O1|Outcome|PEG-IFN + RBV: LTFU (All)|Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
1023336|NCT00761735|E1|Reported Event|PEG-IFN + RBV: LTFU|Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.
1023337|NCT00761631|B5|Baseline|Total|Total of all reporting groups
1023338|NCT00761631|B4|Baseline|13vPnC Group 4|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
1023339|NCT00761631|B3|Baseline|13vPnC Group 3|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
1023340|NCT00761631|B2|Baseline|13vPnC Group 2 (Cohort 1 and 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to and after protocol amendment to increase sample size (Cohort 1 and Cohort 2, combined)
1023341|NCT00761631|B1|Baseline|13vPnC Group 1 (Cohort 1 and 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to and after protocol amendment to increase sample size (Cohort 1 and Cohort 2, combined)
1023342|NCT00761631|P6|Participant Flow|13vPnC Group 4|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
1023343|NCT00761631|P5|Participant Flow|13vPnC Group 3|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
1023344|NCT00761631|P4|Participant Flow|13vPnC Group 2 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
1023345|NCT00761631|P3|Participant Flow|13vPnC Group 1 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
1023346|NCT00761631|P2|Participant Flow|13vPnC Group 2 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
1023347|NCT00761631|P1|Participant Flow|13vPnC Group 1 (Cohort 1)|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7-valent pneumococcal conjugate vaccine (7vPnC). Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
1023348|NCT00761631|O2|Outcome|13vPnC Group 1 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
1023349|NCT00761631|O1|Outcome|13vPnC Group 1 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
1023351|NCT00761631|O5|Outcome|13vPnC Group 3|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
1023352|NCT00761631|O4|Outcome|13vPnC Group 2 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
1023353|NCT00761631|O3|Outcome|13vPnC Group 1 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
1023354|NCT00761631|O2|Outcome|13vPnC Group 2 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
1023355|NCT00761631|O1|Outcome|13vPnC Group 1 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
1023356|NCT00761631|O2|Outcome|13vPnC Group 1 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
1023357|NCT00761631|O1|Outcome|13vPnC Group 1 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
1023358|NCT00761631|O6|Outcome|13vPnC Group 4|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
1023359|NCT00761631|O5|Outcome|13vPnC Group 3|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
1023360|NCT00761631|O4|Outcome|13vPnC Group 2 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
1023361|NCT00761631|O3|Outcome|13vPnC Group 1 (Cohort 2)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
1023362|NCT00761631|O2|Outcome|13vPnC Group 2 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
1023363|NCT00761631|O1|Outcome|13vPnC Group 1 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
1023364|NCT00761631|O2|Outcome|13vPnC Group 4|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
1023365|NCT00761631|O1|Outcome|13vPnC Group 3|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
1023366|NCT00761631|O1|Outcome|13vPnC Group 3|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
1023367|NCT00761631|O2|Outcome|13vPnC Group 2 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
1023368|NCT00761631|O1|Outcome|13vPnC Group 1 (Cohort 1)|13vPnC (0.5mL dose) administered intramuscularly at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
1023369|NCT00761631|E12|Reported Event|6-Month Follow-up 13vPnC Group 4|6 -Month Follow-up Telephone Contact for participants in Group 4.
1023370|NCT00761631|E11|Reported Event|13vPnC Group 4|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must not have received 7vPnC or any other pneumococcal vaccine.
1023371|NCT00761631|E10|Reported Event|6-Month Follow-up 13vPnC Group 3|6-month follow-up telephone contact for participants in Group 3.
1023372|NCT00761631|E9|Reported Event|13vPnC Group 3|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 1 dose of 7vPnC.
1023373|NCT00761631|E8|Reported Event|6-Month Follow-up 13vPnC Group 2 (Cohort 1 and 2)|6-month follow-up telephone contact for participants in Group 2 (Cohort 1 and 2).
1023374|NCT00761631|E7|Reported Event|6-Month Follow-up 13vPnC Group 1 (Cohort 1 and 2)|6-month follow-up telephone contact for participants in Group 1 (Cohort 1 and 2).
1023375|NCT00761631|E6|Reported Event|13vPnC Group 2 (Cohort 2) Dose 1|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
1023376|NCT00761631|E5|Reported Event|13vPnC Group 1 (Cohort 2) Dose 2|13vPnC (0.5mL dose) administered intramuscularly anytime from Day 56 to Day 70. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
1023377|NCT00761631|E4|Reported Event|13vPnC Group 1 (Cohort 2) Dose 1|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled after protocol amendment to increase sample size (Cohort 2).
1023378|NCT00761631|E3|Reported Event|13vPnC Group 2 (Cohort 1) Dose 1|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
1023577|NCT00761202|O2|Outcome|Sodium Hyaluronate|
1023578|NCT00761202|O1|Outcome|Carboxymethylcellulose and Glycerin|
1023379|NCT00761631|E2|Reported Event|13vPnC Group 1 (Cohort 1) Dose 2|13vPnC (0.5mL dose) administered intramuscularly anytime from Day 56 to Day 70. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
1023380|NCT00761631|E1|Reported Event|13vPnC Group 1 (Cohort 1) Dose 1|13vPnC (0.5mL dose) administered intramuscularly at baseline. Participants must have previously received at least 3 doses of 7vPnC. Includes participants enrolled prior to protocol amendment to increase sample size (Cohort 1).
1023381|NCT00761605|B1|Baseline|Paliperidone|Paliperidone oral tablet was administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
1023382|NCT00761605|P1|Participant Flow|Paliperidone|Paliperidone oral tablet was administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
1023383|NCT00761605|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
1023384|NCT00761605|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
1023385|NCT00761605|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
1023386|NCT00761605|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
1023387|NCT00761605|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
1023388|NCT00761605|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
1023389|NCT00761605|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
1023390|NCT00761605|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
1023391|NCT00761605|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
1023392|NCT00761605|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
1023393|NCT00761605|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
1023394|NCT00761605|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
1023395|NCT00761605|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
1023396|NCT00761605|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
1023397|NCT00761605|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
1023398|NCT00761605|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
1023399|NCT00761605|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
1023400|NCT00761605|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
1023401|NCT00761605|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
1023402|NCT00761605|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
1023403|NCT00761605|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
1023404|NCT00761605|O3|Outcome|Paliperidone (Lack of Compliance Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
1023405|NCT00761605|O2|Outcome|Paliperidone (Lack of Tolerability Group)|Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
1023406|NCT00761605|O1|Outcome|Paliperidone (Lack of Efficacy Group)|Paliperidone Extended-release (ER) tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
1023407|NCT00761605|E1|Reported Event|Paliperidone|Paliperidone oral tablet was administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
1023408|NCT00761592|B3|Baseline|Total|Total of all reporting groups
1023409|NCT00761592|B2|Baseline|Botulinum Toxin Type A 150kDa|
1023410|NCT00761592|B1|Baseline|Botulinum Toxin Type A 900kDa|
1023411|NCT00761592|P2|Participant Flow|Botulinum Toxin Type A 150kDa|
1023412|NCT00761592|P1|Participant Flow|Botulinum Toxin Type A 900kDa|
1023413|NCT00761592|O2|Outcome|Botulinum Toxin Type A 150kDa|
1023414|NCT00761592|O1|Outcome|Botulinum Toxin Type A 900kDa|
1023415|NCT00761592|O2|Outcome|Botulinum Toxin Type A 150kDa|
1023416|NCT00761592|O1|Outcome|Botulinum Toxin Type A 900kDa|
1023417|NCT00761592|O2|Outcome|Botulinum Toxin Type A 150kDa|
1023418|NCT00761592|O1|Outcome|Botulinum Toxin Type A 900kDa|
1023419|NCT00761592|O2|Outcome|Botulinum Toxin Type A 150kDa|
1023420|NCT00761592|O1|Outcome|Botulinum Toxin Type A 900kDa|
1023421|NCT00761592|O2|Outcome|Botulinum Toxin Type A 150kDa|
1023422|NCT00761592|O1|Outcome|Botulinum Toxin Type A 900kDa|
1023423|NCT00761592|E2|Reported Event|Botulinum Toxin Type A 150kDa|
1023424|NCT00761592|E1|Reported Event|Botulinum Toxin Type A 900kDa|
1023425|NCT00761579|B1|Baseline|Paliperidone|Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg) for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day.
1023426|NCT00761579|P1|Participant Flow|Paliperidone|Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg) for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day.
1023427|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
1023579|NCT00761202|O2|Outcome|Sodium Hyaluronate|
1023580|NCT00761202|O1|Outcome|Carboxymethylcellulose and Glycerin|
1023581|NCT00761202|E2|Reported Event|Sodium Hyaluronate|
1023428|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
1023429|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
1023430|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
1023431|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
1023432|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
1023433|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
1023434|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
1023435|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
1023436|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
1023437|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
1023438|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
1023439|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
1023440|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
1023441|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
1023442|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
1023443|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
1023582|NCT00761202|E1|Reported Event|Carboxymethylcellulose and Glycerin|
1023583|NCT00761189|B1|Baseline|Paliperidone|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
1023444|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
1023445|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
1023446|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
1023447|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
1023448|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
1023449|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
1023450|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
1023451|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
1023452|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
1023453|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
1023454|NCT00761579|O3|Outcome|Paliperidone ER: Lack of Compliance|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
1023455|NCT00761579|O2|Outcome|Paliperidone ER: Lack of Tolerability|Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug).
1023456|NCT00761579|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone ER tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
1023457|NCT00761579|E1|Reported Event|Paliperidone|Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg) for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day.
1023458|NCT00761527|B1|Baseline|Desloratadine (Aerius) Syrup|"Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:~Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)~Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)~Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)"
1023459|NCT00761527|P1|Participant Flow|Desloratadine (Aerius) Syrup|"Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:~Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)~Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)~Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)"
1023625|NCT00761137|O2|Outcome|Tropicamide - 0.3 mg|Each subject randomly received blinded a thin film containing 0.3 mg active drug ingredient
1023460|NCT00761527|O1|Outcome|Desloratadine (Aerius) Syrup|"Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:~Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)~Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)~Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)"
1023461|NCT00761527|O1|Outcome|Desloratadine (Aerius) Syrup|"Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:~Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)~Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)~Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)"
1023462|NCT00761527|O1|Outcome|Desloratadine (Aerius) Syrup|"Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:~Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)~Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)~Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)"
1023463|NCT00761527|O1|Outcome|Desloratadine (Aerius) Syrup|"Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:~Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)~Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)~Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)"
1023464|NCT00761527|E1|Reported Event|Desloratadine (Aerius) Syrup|"Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:~Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)~Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)~Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)"
1023465|NCT00761514|B1|Baseline|Open-label Treatment With 40 mg Adalimumab Every Other Week|All subjects received 40 mg Adalimumab by subcutaneous injection every other week for up to 24 weeks.
1023466|NCT00761514|P1|Participant Flow|Open-label Treatment With 40 mg Adalimumab Every Other Week|All subjects received 40 mg Adalimumab by subcutaneous injection every other week for up to 24 weeks.
1023467|NCT00761514|O1|Outcome|Open-label Treatment With Adalimumab 40 mg Every Other Week|All subjects received 40 mg adalimumab by subcutaneous injection every other week for up to 24 weeks.
1023468|NCT00761514|O1|Outcome|Open-label Treatment With Adalimumab 40 mg Every Other Week|All subjects received 40 mg adalimumab by subcutaneous injection every other week for up to 24 weeks.
1023469|NCT00761514|E1|Reported Event|Open-label Treatment With 40 mg Adalimumab Every Other Week|All subjects received 40 mg Adalimumab by subcutaneous injection every other week for up to 24 weeks.
1023470|NCT00761462|B3|Baseline|Total|Total of all reporting groups
1023471|NCT00761462|B2|Baseline|Non-quinolone Antibiotic|Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
1023472|NCT00761462|B1|Baseline|Ciprofloxacin|Subjects receiving Ciprofloxacin (group followed-up for 5 years)
1023473|NCT00761462|P2|Participant Flow|Non-quinolone Antibiotic|Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
1023474|NCT00761462|P1|Participant Flow|Ciprofloxacin|Subjects receiving Ciprofloxacin (group followed-up for 5 years)
1023475|NCT00761462|O2|Outcome|Non-quinolone Antibiotic|Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
1023476|NCT00761462|O1|Outcome|Ciprofloxacin|Subjects receiving Ciprofloxacin (group followed-up for 5 years)
1023477|NCT00761462|O2|Outcome|Non-quinolone Antibiotic|Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
1023478|NCT00761462|O1|Outcome|Ciprofloxacin|Subjects receiving Ciprofloxacin (group followed-up for 5 years)
1023479|NCT00761462|E2|Reported Event|Non-quinolone Antibiotic|Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
1023480|NCT00761462|E1|Reported Event|Ciprofloxacin|Subjects receiving Ciprofloxacin (group followed-up for 5 years)
1023481|NCT00761345|B1|Baseline|Radiotherapy and Chemotherapy|"gemcitabine will be administered at 1000mg/m2 IV on days 1 and 8 of each 21 day cycle. erlotinib at either 100mg (cohort 1-3) or 150mg (cohort 4) PO daily. Low dose fractionated radiotherapy (LDRT) will be given BID on days 1 and 2 and 8 and 9 of each 21 day cycle~gemcitabine: gemcitabine 1000mg/m2 days 1 and 8 of each 21 day cycle.~Erlotinib: Erlotinib 100mg or 150mg daily of each 21 day cycle~low dose fractionated radiotherapy: low dose fractionated radiotherapy day 1 and 2, day 8 and 9 of each 21 day cycle"
1023482|NCT00761345|P1|Participant Flow|Radiotherapy and Chemotherapy|"gemcitabine will be administered at 1000mg/m2 IV on days 1 and 8 of each 21 day cycle. erlotinib at either 100mg (cohort 1-3) or 150mg (cohort 4) PO daily. Low dose fractionated radiotherapy (LDRT) will be given BID on days 1 and 2 and 8 and 9 of each 21 day cycle~gemcitabine: gemcitabine 1000mg/m2 days 1 and 8 of each 21 day cycle.~Erlotinib: Erlotinib 100mg or 150mg daily of each 21 day cycle~low dose fractionated radiotherapy: low dose fractionated radiotherapy day 1 and 2, day 8 and 9 of each 21 day cycle"
1023483|NCT00761345|O1|Outcome|Radiotherapy and Chemotherapy|"gemcitabine will be administered at 1000mg/m2 IV on days 1 and 8 of each 21 day cycle. erlotinib at either 100mg (cohort 1-3) or 150mg (cohort 4) PO daily. Low dose fractionated radiotherapy (LDRT) will be given BID on days 1 and 2 and 8 and 9 of each 21 day cycle~gemcitabine: gemcitabine 1000mg/m2 days 1 and 8 of each 21 day cycle.~Erlotinib: Erlotinib 100mg or 150mg daily of each 21 day cycle~low dose fractionated radiotherapy: low dose fractionated radiotherapy day 1 and 2, day 8 and 9 of each 21 day cycle"
1023626|NCT00761137|O1|Outcome|Tropicamide - Placebo|Each subject randomly received blinded a placebo thin film containing no active drug ingredient
1023484|NCT00761345|E1|Reported Event|Radiotherapy and Chemotherapy|"gemcitabine will be administered at 1000mg/m2 IV on days 1 and 8 of each 21 day cycle. erlotinib at either 100mg (cohort 1-3) or 150mg (cohort 4) PO daily. Low dose fractionated radiotherapy (LDRT) will be given BID on days 1 and 2 and 8 and 9 of each 21 day cycle~gemcitabine: gemcitabine 1000mg/m2 days 1 and 8 of each 21 day cycle.~Erlotinib: Erlotinib 100mg or 150mg daily of each 21 day cycle~low dose fractionated radiotherapy: low dose fractionated radiotherapy day 1 and 2, day 8 and 9 of each 21 day cycle"
1023485|NCT00761319|B3|Baseline|Total|Total of all reporting groups
1023486|NCT00761319|B2|Baseline|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
1023487|NCT00761319|B1|Baseline|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
1023488|NCT00761319|P2|Participant Flow|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
1023489|NCT00761319|P1|Participant Flow|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
1023490|NCT00761319|O2|Outcome|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
1023491|NCT00761319|O1|Outcome|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
1023492|NCT00761319|O2|Outcome|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
1023493|NCT00761319|O1|Outcome|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
1023494|NCT00761319|E2|Reported Event|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
1023495|NCT00761319|E1|Reported Event|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
1023496|NCT00761306|B1|Baseline|Vortioxetine 5 or 10 mg/Day|tablets; orally
1023497|NCT00761306|P1|Participant Flow|Vortioxetine 5 or 10 mg/Day|tablets; orally
1023498|NCT00761306|O1|Outcome|Vortioxetine 5 or 10 mg/Day|tablets; orally
1023499|NCT00761306|O1|Outcome|Vortioxetine 5 or 10 mg/Day|tablets; orally
1023500|NCT00761306|O1|Outcome|Vortioxetine 5 or 10 mg/Day|tablets; orally
1023501|NCT00761306|O1|Outcome|Vortioxetine 5 or 10 mg/Day|tablets; orally
1023502|NCT00761306|O1|Outcome|Vortioxetine 5 or 10 mg/Day|tablets; orally
1023503|NCT00761306|O1|Outcome|Vortioxetine 5 or 10 mg/Day|tablets; orally
1023504|NCT00761306|E1|Reported Event|Vortioxetine 5 or 10 mg/Day|
1023505|NCT00761280|B3|Baseline|Total|Total of all reporting groups
1023506|NCT00761280|B2|Baseline|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
1023507|NCT00761280|B1|Baseline|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
1023508|NCT00761280|P2|Participant Flow|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
1023509|NCT00761280|P1|Participant Flow|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
1023510|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
1023511|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
1023512|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
1023513|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
1023514|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
1023515|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
1023516|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
1023517|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
1023518|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
1023519|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
1023520|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
1023521|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
1023522|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
1023523|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
1023524|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
1023525|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
1023526|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
1023527|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
1023528|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
1023719|NCT00761007|O1|Outcome|Ibodutant 10 mg|oral tablet, once daily
1023529|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
1023530|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
1023531|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
1023532|NCT00761280|O2|Outcome|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
1023533|NCT00761280|O1|Outcome|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
1023534|NCT00761280|E2|Reported Event|Chemotherapy|"Temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle, up to 26 cycles.~OR carmustine: i.v. administration, up to 200 mg/sqm/day, 1 day per cycle, up to 8 cycles;~OR lomustine: capsules, 110 mg/sqm/day, 1 day per cycle, up to 8 cycles.~Only 1 of these 3 drugs/interventions is administered per patient in the comparator arm."
1023535|NCT00761280|E1|Reported Event|Trabedersen 10 µM|"10 µM trabedersen (AP 12009), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks.~Drug delivery system for administration of AP 12009: Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).~Placement of Drug Delivery System: Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT."
1023536|NCT00761215|B4|Baseline|Total|Total of all reporting groups
1023537|NCT00761215|B3|Baseline|TR-701 400 mg|Oral TR-701 400 mg once daily for 5 to 7 days
1023538|NCT00761215|B2|Baseline|TR-701 300 mg|Oral TR-701 300 mg once daily for 5 to 7 days
1023539|NCT00761215|B1|Baseline|TR-701 200 mg|Oral TR-701 200 mg once daily for 5 to 7 days
1023540|NCT00761215|P3|Participant Flow|TR-701 400 mg|Oral TR-701 400 mg once daily for 5 to 7 days
1023541|NCT00761215|P2|Participant Flow|TR-701 300 mg|Oral TR-701 300 mg once daily for 5 to 7 days
1023542|NCT00761215|P1|Participant Flow|TR-701 200 mg|Oral TR-701 200 mg once daily for 5 to 7 days
1023543|NCT00761215|O3|Outcome|TR-701 400 mg|Oral TR-701 400 mg once daily for 5 to 7 days
1023544|NCT00761215|O2|Outcome|TR-701 300 mg|Oral TR-701 300 mg once daily for 5 to 7 days
1023545|NCT00761215|O1|Outcome|TR-701 200 mg|Oral TR-701 200 mg once daily for 5 to 7 days
1023546|NCT00761215|O3|Outcome|TR-701 400 mg|Oral TR-701 400 mg for 5 to 7 days
1023547|NCT00761215|O2|Outcome|TR-701 300 mg|Oral TR-701 300 mg for 5 to 7 days
1023548|NCT00761215|O1|Outcome|TR-701 200 mg|Oral TR-701 200 mg for 5 to 7 days
1023549|NCT00761215|O3|Outcome|TR-701 400 mg|Oral TR-701 400 mg for 5 to 7 days
1023550|NCT00761215|O2|Outcome|TR-701 300 mg|Oral TR-701 300 mg for 5 to 7 days
1023551|NCT00761215|O1|Outcome|TR-701 200 mg|Oral TR-701 200 mg for 5 to 7 days
1023552|NCT00761215|O3|Outcome|TR-701 400 mg|Oral TR-701 400 mg for 5 to 7 days
1023553|NCT00761215|O2|Outcome|TR-701 300 mg|Oral TR-701 300 mg for 5 to 7 days
1023554|NCT00761215|O1|Outcome|TR-701 200 mg|Oral TR-701 200 mg for 5 to 7 days
1023555|NCT00761215|O3|Outcome|TR-701 400 mg|Oral TR-701 400 mg for 5 to 7 days
1023556|NCT00761215|O2|Outcome|TR-701 300 mg|Oral TR-701 300 mg for 5 to 7 days
1023557|NCT00761215|O1|Outcome|TR-701 200 mg|Oral TR-701 200 mg for 5 to 7 days
1023558|NCT00761215|O3|Outcome|TR-701 400 mg|Oral TR-701 400 mg for 5 to 7 days
1023559|NCT00761215|O2|Outcome|TR-701 300 mg|Oral TR-701 300 mg for 5 to 7 days
1023560|NCT00761215|O1|Outcome|TR-701 200 mg|Oral TR-701 200 mg for 5 to 7 days
1023561|NCT00761215|E3|Reported Event|TR-701 400 mg|Oral TR-701 400 mg once daily for 5 to 7 days
1023562|NCT00761215|E2|Reported Event|TR-701 300 mg|Oral TR-701 300 mg once daily for 5 to 7 days
1023563|NCT00761215|E1|Reported Event|TR-701 200 mg|Oral TR-701 200 mg once daily for 5 to 7 days
1023564|NCT00761202|B3|Baseline|Total|Total of all reporting groups
1023565|NCT00761202|B2|Baseline|Sodium Hyaluronate|
1023566|NCT00761202|B1|Baseline|Carboxymethylcellulose and Glycerin|
1023567|NCT00761202|P2|Participant Flow|Sodium Hyaluronate|
1023568|NCT00761202|P1|Participant Flow|Carboxymethylcellulose and Glycerin|
1023569|NCT00761202|O2|Outcome|Sodium Hyaluronate|
1023570|NCT00761202|O1|Outcome|Carboxymethylcellulose and Glycerin|
1023571|NCT00761202|O2|Outcome|Sodium Hyaluronate|
1023572|NCT00761202|O1|Outcome|Carboxymethylcellulose and Glycerin|
1023584|NCT00761189|P1|Participant Flow|Paliperidone|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
1023585|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
1023586|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
1023587|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
1023588|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
1023589|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
1023590|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
1023591|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
1023592|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
1023593|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
1023594|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
1023595|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
1023596|NCT00761189|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
1023597|NCT00761189|E1|Reported Event|Paliperidone|Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator’s discretion.
1023598|NCT00761176|B3|Baseline|Total|Total of all reporting groups
1023599|NCT00761176|B2|Baseline|Standard of Care|Standardized wound care is used
1023600|NCT00761176|B1|Baseline|Active|The Provant Wound Therapy System: The Provant Wound Therapy System is a safe adjuvant non-invasive medical device.
1023601|NCT00761176|P2|Participant Flow|Active|Provant Therapy Device
1023602|NCT00761176|P1|Participant Flow|Standard of Care|standardized care will be used for wound care on patients randomized to this arm.
1023603|NCT00761176|O2|Outcome|Active Provant Device|"Active Device~The Provant Wound Therapy System: The Provant Wound Therapy System is a safe adjuvant non-invasive medical device."
1023604|NCT00761176|O1|Outcome|Standard of Care|Standard of Care will be utilized without the device.
1023605|NCT00761176|E2|Reported Event|Active|Provant Therapy Device
1023606|NCT00761176|E1|Reported Event|Standard of Care|standardized care will be used for wound care on patients randomized to this arm.
1023607|NCT00761150|B4|Baseline|Total|Total of all reporting groups
1023608|NCT00761150|B3|Baseline|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
1023609|NCT00761150|B2|Baseline|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
1023610|NCT00761150|B1|Baseline|Nonrandomized|2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks during the open-label period. These participants enrolled in the study and received at least 1 dose of study drug, and either discontinued during the open-label period or were not randomized and did not progress to the double-blind period.
1023611|NCT00761150|P3|Participant Flow|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
1023612|NCT00761150|P2|Participant Flow|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
1023613|NCT00761150|P1|Participant Flow|Open-label ABT-712|2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).
1023614|NCT00761150|O2|Outcome|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
1023615|NCT00761150|O1|Outcome|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
1023616|NCT00761150|O2|Outcome|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
1023617|NCT00761150|O1|Outcome|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
1023618|NCT00761150|E3|Reported Event|Double-blind Placebo|2 placebo tablets, twice daily, for 4 weeks (double-blind period).
1023619|NCT00761150|E2|Reported Event|Double-blind ABT-712|2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
1023620|NCT00761150|E1|Reported Event|Open-label ABT-712|2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).
1023621|NCT00761137|B1|Baseline|All Study Participants|This study was a double-blind, randomized, placebo controlled, two-phased, Latin-square crossover study. Subjects received three single-doses of tropicamide or placebo in random order, with a 7-day washout period.
1023622|NCT00761137|P1|Participant Flow|All Participants|subjects randomly received (blinded) each of the 4 doses at different visits - 0 mg, 0.3 mg, 1mg, 3 mg Drug: Tropicamide
1023623|NCT00761137|O4|Outcome|Tropicamide 3 mg|Each subject randomly received blinded a thin film containing 3 mg active drug ingredient
1023624|NCT00761137|O3|Outcome|Tropicamide - 1 mg|Each subject randomly received blinded a thin film containing 1 mg active drug ingredient
1023628|NCT00761137|O3|Outcome|Tropicamide - 1 mg|Each subject randomly received blinded a thin film containing 1 mg active drug ingredient
1023629|NCT00761137|O2|Outcome|Tropicamide - 0.3 mg|Each subject randomly received blinded a thin film containing 0.3 mg active drug ingredient
1023630|NCT00761137|O1|Outcome|Tropicamide - Placebo|Each subject randomly received blinded a placebo thin film containing no active drug ingredient
1023631|NCT00761137|E1|Reported Event|All Participants|subjects received (blinded) each of the 4 doses at different visits - 0 mg, 0.3 mg, 1mg, 3 mg Drug: Tropicamide
1023632|NCT00760266|B3|Baseline|Total|Total of all reporting groups
1023633|NCT00760266|B2|Baseline|HCTZ|Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
1023634|NCT00760266|B1|Baseline|Aliskiren/HCTZ|Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks
1023635|NCT00760266|P2|Participant Flow|HCTZ|Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
1023636|NCT00760266|P1|Participant Flow|Aliskiren/HCTZ|Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks
1023637|NCT00760266|O2|Outcome|HCTZ|Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
1023638|NCT00760266|O1|Outcome|Aliskiren/HCTZ|Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks
1023639|NCT00760266|O2|Outcome|HCTZ|Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
1023640|NCT00760266|O1|Outcome|Aliskiren/HCTZ|Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks
1023641|NCT00760266|O2|Outcome|HCTZ|Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
1023642|NCT00760266|O1|Outcome|Aliskiren/HCTZ|Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks
1023643|NCT00760266|O2|Outcome|HCTZ|Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
1023644|NCT00760266|O1|Outcome|Aliskiren/HCTZ|Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks
1023645|NCT00760266|O2|Outcome|HCTZ|Hydrochlorothiazide (HCTZ) 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
1023646|NCT00760266|O1|Outcome|Aliskiren/HCTZ|Aliskiren / Hydrochlorothiazide (HCTZ) 150/12.5 mg: 1 week, Aliskiren / HCTZ 300/25 mg (with or without amlodipine): 7 weeks
1023647|NCT00760266|E2|Reported Event|HCTZ|HCTZ 12.5 mg: 1 week, HCTZ 25 mg (with or without amlodipine): 7 weeks
1023648|NCT00760266|E1|Reported Event|Aliskiren / HCTZ|Aliskiren HCTZ 150/12.5 mg: 1 week, Aliskiren HCTZ 300/25 mg (with or without amlodipine): 7 weeks
1023649|NCT00760214|B4|Baseline|Total|Total of all reporting groups
1023650|NCT00760214|B3|Baseline|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
1023651|NCT00760214|B2|Baseline|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
1023652|NCT00760214|B1|Baseline|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
1023653|NCT00760214|P3|Participant Flow|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
1023654|NCT00760214|P2|Participant Flow|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
1023655|NCT00760214|P1|Participant Flow|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
1023656|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
1023657|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
1023658|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
1023659|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
1023660|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
1023661|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
1023662|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
1023663|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
1023664|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
1023665|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
1023666|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
1023667|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
1023668|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
1023720|NCT00761007|E4|Reported Event|Placebo|oral tablet, once daily
1023669|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
1023670|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
1023671|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
1023672|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
1023673|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
1023674|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
1023675|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
1023676|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
1023677|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
1023678|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
1023679|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
1023680|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
1023681|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
1023682|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
1023683|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
1023684|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
1023685|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
1023686|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
1023687|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
1023688|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
1023689|NCT00760214|O3|Outcome|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
1023690|NCT00760214|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
1023691|NCT00760214|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
1023692|NCT00760214|E3|Reported Event|Ramipril 10 mg QD|Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.
1023693|NCT00760214|E2|Reported Event|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.
1023694|NCT00760214|E1|Reported Event|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.
1023695|NCT00761007|B5|Baseline|Total|Total of all reporting groups
1023696|NCT00761007|B4|Baseline|Placebo|oral tablet, once daily
1023697|NCT00761007|B3|Baseline|Ibodutant 60 mg|oral tablet, once daily
1023698|NCT00761007|B2|Baseline|Ibodutant 30 mg|oral tablet, once daily
1023699|NCT00761007|B1|Baseline|Ibodutant 10 mg|oral tablet, once daily
1023700|NCT00761007|P4|Participant Flow|Placebo|oral tablet, once daily
1023701|NCT00761007|P3|Participant Flow|Ibodutant 60 mg|oral tablet, once daily
1023702|NCT00761007|P2|Participant Flow|Ibodutant 30 mg|oral tablet, once daily
1023703|NCT00761007|P1|Participant Flow|Ibodutant 10 mg|oral tablet, once daily
1023704|NCT00761007|O4|Outcome|Placebo|oral tablet, once daily
1023705|NCT00761007|O3|Outcome|Ibodutant 60 mg|oral tablet, once daily
1023706|NCT00761007|O2|Outcome|Ibodutant 30 mg|oral tablet, once daily
1023707|NCT00761007|O1|Outcome|Ibodutant 10 mg|oral tablet, once daily
1023708|NCT00761007|O4|Outcome|Placebo|oral tablet, once daily
1023709|NCT00761007|O3|Outcome|Ibodutant 60 mg|oral tablet, once daily
1023710|NCT00761007|O2|Outcome|Ibodutant 30 mg|oral tablet, once daily
1023711|NCT00761007|O1|Outcome|Ibodutant 10 mg|oral tablet, once daily
1023712|NCT00761007|O4|Outcome|Placebo|oral tablet, once daily
1023713|NCT00761007|O3|Outcome|Ibodutant 60 mg|oral tablet, once daily
1023714|NCT00761007|O2|Outcome|Ibodutant 30 mg|oral tablet, once daily
1023715|NCT00761007|O1|Outcome|Ibodutant 10 mg|oral tablet, once daily
1023716|NCT00761007|O4|Outcome|Placebo|oral tablet, once daily
1023721|NCT00761007|E3|Reported Event|Ibodutant 60 mg|oral tablet, once daily
1023722|NCT00761007|E2|Reported Event|Ibodutant 30 mg|oral tablet, once daily
1023723|NCT00761007|E1|Reported Event|Ibodutant 10 mg|oral tablet, once daily
1023724|NCT00760877|B3|Baseline|Total|Total of all reporting groups
1023725|NCT00760877|B2|Baseline|Imatinib|Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
1023726|NCT00760877|B1|Baseline|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
1023727|NCT00760877|P2|Participant Flow|Imatinib|Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
1023728|NCT00760877|P1|Participant Flow|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
1023729|NCT00760877|O2|Outcome|Imatinib|Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
1023730|NCT00760877|O1|Outcome|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
1023731|NCT00760877|O2|Outcome|Imatinib|Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
1023732|NCT00760877|O1|Outcome|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
1023733|NCT00760877|O2|Outcome|Imatinib|Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
1023734|NCT00760877|O1|Outcome|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
1023735|NCT00760877|O1|Outcome|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
1023736|NCT00760877|O2|Outcome|Imatinib|Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
1023737|NCT00760877|O1|Outcome|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
1023738|NCT00760877|O2|Outcome|Imatinib|Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
1023739|NCT00760877|O1|Outcome|Nilotinib|Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
1023740|NCT00760877|E3|Reported Event|Imatinib Subset That Crossed Over to Nilotinib|Imatinib subset that crossed over to nilotinib
1023741|NCT00760877|E2|Reported Event|Imatinib|Imatinib
1023742|NCT00760877|E1|Reported Event|Nilotinib|Nilotinib
1023743|NCT00760838|B3|Baseline|Total|Total of all reporting groups
1023744|NCT00760838|B2|Baseline|Azithromycin|"Azithromycin 250 mg~1x/day during 5 days 3x/week afterwards"
1023745|NCT00760838|B1|Baseline|Placebo|"Placebo~1x/day during 5 days 3x/week afterwards"
1023746|NCT00760838|P2|Participant Flow|Azithromycin|"Azithromycin 250 mg~1x/day during 5 days 3x/week afterwards"
1023747|NCT00760838|P1|Participant Flow|Placebo|"Placebo~1x/day during 5 days 3x/week afterwards"
1023748|NCT00760838|O2|Outcome|Azithromycin|"Azithromycin 250 mg~1x/day during 5 days 3x/week afterwards"
1023749|NCT00760838|O1|Outcome|Placebo|"Placebo~1x/day during 5 days 3x/week afterwards"
1023750|NCT00760838|O2|Outcome|Azithromycin|"Azithromycin 250 mg~1x/day during 5 days 3x/week afterwards"
1023751|NCT00760838|O1|Outcome|Placebo|"Placebo~1x/day during 5 days 3x/week afterwards"
1023752|NCT00760838|O2|Outcome|Azithromycin|"Azithromycin 250 mg~1x/day during 5 days 3x/week afterwards"
1023753|NCT00760838|O1|Outcome|Placebo|"Placebo~1x/day during 5 days 3x/week afterwards"
1023754|NCT00760838|O2|Outcome|Azithromycin|"Azithromycin 250 mg~1x/day during 5 days 3x/week afterwards"
1023755|NCT00760838|O1|Outcome|Placebo|"Placebo~1x/day during 5 days 3x/week afterwards"
1023756|NCT00760838|O2|Outcome|Azithromycin|"Azithromycin 250 mg~1x/day during 5 days 3x/week afterwards"
1023757|NCT00760838|O1|Outcome|Placebo|"Placebo~1x/day during 5 days 3x/week afterwards"
1023758|NCT00760838|O2|Outcome|Azithromycin|"Azithromycin 250 mg~1x/day during 5 days 3x/week afterwards"
1023759|NCT00760838|O1|Outcome|Placebo|"Placebo~1x/day during 5 days 3x/week afterwards"
1023760|NCT00760838|E2|Reported Event|Azithromycin|"Azithromycin 250 mg~1x/day during 5 days 3x/week afterwards"
1023761|NCT00760838|E1|Reported Event|Placebo|"Placebo~1x/day during 5 days 3x/week afterwards"
1023762|NCT00760747|B3|Baseline|Total|Total of all reporting groups
1023763|NCT00760747|B2|Baseline|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
1023764|NCT00760747|B1|Baseline|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
1023765|NCT00760747|P2|Participant Flow|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
1023766|NCT00760747|P1|Participant Flow|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2 milligrams per kilogram per day (mg/kg/day), orally (PO), during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
1023767|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
1023768|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
1023769|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
1023770|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
1023771|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
1023772|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
1023773|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
1023774|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
1023775|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
1023776|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
1023777|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
1023778|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
1023779|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
1023780|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
1023781|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
1023782|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
1023783|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
1023784|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
1023785|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
1023786|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
1023787|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
1023788|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
1023789|NCT00760747|O2|Outcome|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
1023790|NCT00760747|O1|Outcome|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
1023791|NCT00760747|E2|Reported Event|Fast Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
1023792|NCT00760747|E1|Reported Event|Slow Switching Group|Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.
1023793|NCT00760669|B1|Baseline|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
1023794|NCT00760669|P1|Participant Flow|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
1023795|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
1023908|NCT00760578|O4|Outcome|Placebo|Microcrystalline cellulose taken once daily for 28 days
1023796|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
1023797|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
1023798|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
1023799|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
1023800|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
1023801|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
1023802|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
1023803|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
1023840|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
1023841|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
1023842|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
1023804|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
1023805|NCT00760669|O1|Outcome|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
1023806|NCT00760669|E1|Reported Event|Participants Receiving Infliximab|Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.
1023807|NCT00760617|B4|Baseline|Total|Total of all reporting groups
1023808|NCT00760617|B3|Baseline|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
1023809|NCT00760617|B2|Baseline|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
1023810|NCT00760617|B1|Baseline|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
1023811|NCT00760617|P3|Participant Flow|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
1023812|NCT00760617|P2|Participant Flow|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
1023813|NCT00760617|P1|Participant Flow|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
1023814|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
1023815|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
1023816|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
1023817|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
1023818|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
1023819|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
1023820|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
1023821|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
1023822|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
1023823|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
1023824|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
1023825|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
1023826|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
1023827|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
1023828|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
1023829|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
1023830|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
1023831|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
1023832|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
1023833|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
1023834|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
1023835|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
1023836|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
1023837|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
1023838|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
1023839|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
1023900|NCT00760578|O4|Outcome|Placebo|Microcrystaline cellulose once daily
1023843|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
1023844|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
1023845|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
1023846|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
1023847|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
1023848|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
1023849|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
1023850|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
1023851|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
1023852|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
1023853|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
1023854|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
1023855|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
1023856|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
1023857|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
1023858|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
1023859|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
1023860|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
1023861|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
1023862|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
1023863|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
1023864|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
1023865|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
1023866|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
1023867|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
1023868|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
1023869|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
1023870|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
1023871|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
1023872|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
1023873|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
1023874|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
1023875|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
1023876|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
1023877|NCT00760617|O3|Outcome|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
1023878|NCT00760617|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
1023879|NCT00760617|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
1023880|NCT00760617|E3|Reported Event|Fluarix Young Group|Subjects aged 18-40 years received 1 dose of Fluarix vaccine
1023881|NCT00760617|E2|Reported Event|Fluarix Elderly Group|Subjects aged ≥65 years received 1 dose of Fluarix vaccine
1023882|NCT00760617|E1|Reported Event|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
1023883|NCT00760578|B5|Baseline|Total|Total of all reporting groups
1023884|NCT00760578|B4|Baseline|Placebo|Microcrystaline cellulose once daily
1023885|NCT00760578|B3|Baseline|Pioglitazone|Pioglitazone 45 mg once daily
1023886|NCT00760578|B2|Baseline|MSDC-0160 220 mg|MSDC-0160 220 mg once daily
1023887|NCT00760578|B1|Baseline|MSDC-0160 90 mg|MSDC-0160 90 mg once daily
1023888|NCT00760578|P4|Participant Flow|Placebo|Microcrystaline cellulose once daily
1023889|NCT00760578|P3|Participant Flow|Pioglitazone|Pioglitazone 45 mg once daily
1023890|NCT00760578|P2|Participant Flow|MSDC-0160 220 mg|MSDC-0160 220 mg once daily
1023891|NCT00760578|P1|Participant Flow|MSDC-0160 90 mg|MSDC-0160 90 mg once daily
1023892|NCT00760578|O4|Outcome|Placebo|Microcrystaline cellulose once daily
1023893|NCT00760578|O3|Outcome|Pioglitazone|Pioglitazone 45 mg once daily
1023894|NCT00760578|O2|Outcome|MSDC-0160 220 mg|MSDC-0160 220 mg once daily
1023895|NCT00760578|O1|Outcome|MSDC-0160 90 mg|MSDC-0160 90 mg once daily
1023896|NCT00760578|O4|Outcome|Placebo|Microcrystaline cellulose once daily
1023897|NCT00760578|O3|Outcome|Pioglitazone|Pioglitazone 45 mg once daily
1023898|NCT00760578|O2|Outcome|MSDC-0160 220 mg|MSDC-0160 220 mg once daily
1023899|NCT00760578|O1|Outcome|MSDC-0160 90 mg|MSDC-0160 90 mg once daily
1023909|NCT00760578|O3|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg taken once daily for 28 days
1023910|NCT00760578|O2|Outcome|Mitoglitazone 220 mg|Mitaglitazone 220 mg taken once daily for 28 days
1023911|NCT00760578|O1|Outcome|Mitoglitazone 90 mg|Mitoglitazone 90 mg taken once daily for 28 days
1023912|NCT00760578|O4|Outcome|Placebo|Microcrystalline cellulose taken once daily for 28 days
1023913|NCT00760578|O3|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg taken once daily for 28 days
1023914|NCT00760578|O2|Outcome|Mitoglitazone 220 mg|Mitaglitazone 220 mg taken once daily for 28 days
1023915|NCT00760578|O1|Outcome|Mitoglitazone 90 mg|Mitoglitazone 90 mg taken once daily for 28 days
1023916|NCT00760578|O4|Outcome|Placebo|Placebo (microcrystalline cellulose) taken once daily for 28 days
1023917|NCT00760578|O3|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg taken once daily for 28 days
1023918|NCT00760578|O2|Outcome|Mitoglitazone 220 mg|Mitaglitazone 220 mg taken once daily for 28 days
1023919|NCT00760578|O1|Outcome|Mitoglitazone 90 mg|Mitoglitazone 90 mg taken once daily for 28 days
1023920|NCT00760578|E4|Reported Event|MSDC-0160 220 mg|MSDC-0160 220 mg once daily
1023921|NCT00760578|E3|Reported Event|Pioglitazone|Pioglitazone 45 mg once daily
1023922|NCT00760578|E2|Reported Event|Placebo|Microcrystaline cellulose once daily
1023923|NCT00760578|E1|Reported Event|MSDC-0160 90 mg|MSDC-0160 90 mg once daily
1023924|NCT00760552|B3|Baseline|Total|Total of all reporting groups
1023925|NCT00760552|B2|Baseline|Arm 2|"VA patients with uncontrolled HTN.~Low Intensity Intervention: Patients randomized to the low intensity group will receive management by their PCP and a three-part intervention that was effective in a recent VA study."
1023926|NCT00760552|B1|Baseline|Arm 1|"VA patients with uncontrolled HTN.~High Intensity Intervention: High Intensity patients will be seen by the pharmacist at 3-6 month intervals, depending upon if patient is at goal BP. During these visits, the pharmacist will: 1) review barriers to BP control; 2) assess progress toward overcoming such barriers; 3) determine adherence; and 4) assess potential side effects. If the BP is at goal, the patient will be given encouragement and told to continue the regimen. If the BP is not at goal, the pharmacist will develop a new treatment strategy. If the treatment changes were in the plan negotiated with the physician, the PCP will simply be informed. If new changes are recommended, the pharmacist will develop a new treatment plan and review it with the PCP."
1023927|NCT00760552|P2|Participant Flow|Arm 2|"VA patients with uncontrolled HTN.~Low Intensity Intervention: Patients randomized to the low intensity group will receive management by their PCP and a three-part intervention that was effective in a recent VA study."
1023928|NCT00760552|P1|Participant Flow|Arm 1|"VA patients with uncontrolled HTN.~High Intensity Intervention: High Intensity patients will be seen by the pharmacist at 3-6 month intervals, depending upon if patient is at goal BP. During these visits, the pharmacist will: 1) review barriers to BP control; 2) assess progress toward overcoming such barriers; 3) determine adherence; and 4) assess potential side effects. If the BP is at goal, the patient will be given encouragement and told to continue the regimen. If the BP is not at goal, the pharmacist will develop a new treatment strategy. If the treatment changes were in the plan negotiated with the physician, the PCP will simply be informed. If new changes are recommended, the pharmacist will develop a new treatment plan and review it with the PCP."
1023929|NCT00760552|O2|Outcome|Arm 2|"VA patients with uncontrolled HTN.~Low Intensity Intervention: Patients randomized to the low intensity group will receive management by their PCP and a three-part intervention that was effective in a recent VA study."
1023930|NCT00760552|O1|Outcome|Arm 1|"VA patients with uncontrolled HTN.~High Intensity Intervention: High Intensity patients will be seen by the pharmacist at 3-6 month intervals, depending upon if patient is at goal BP. During these visits, the pharmacist will: 1) review barriers to BP control; 2) assess progress toward overcoming such barriers; 3) determine adherence; and 4) assess potential side effects. If the BP is at goal, the patient will be given encouragement and told to continue the regimen. If the BP is not at goal, the pharmacist will develop a new treatment strategy. If the treatment changes were in the plan negotiated with the physician, the PCP will simply be informed. If new changes are recommended, the pharmacist will develop a new treatment plan and review it with the PCP."
1023931|NCT00760552|E2|Reported Event|Arm 2|"VA patients with uncontrolled HTN.~Low Intensity Intervention: Patients randomized to the low intensity group will receive management by their PCP and a three-part intervention that was effective in a recent VA study."
1023932|NCT00760552|E1|Reported Event|Arm 1|"VA patients with uncontrolled HTN.~High Intensity Intervention: High Intensity patients will be seen by the pharmacist at 3-6 month intervals, depending upon if patient is at goal BP. During these visits, the pharmacist will: 1) review barriers to BP control; 2) assess progress toward overcoming such barriers; 3) determine adherence; and 4) assess potential side effects. If the BP is at goal, the patient will be given encouragement and told to continue the regimen. If the BP is not at goal, the pharmacist will develop a new treatment strategy. If the treatment changes were in the plan negotiated with the physician, the PCP will simply be informed. If new changes are recommended, the pharmacist will develop a new treatment plan and review it with the PCP."
1023933|NCT00760526|B3|Baseline|Total|Total of all reporting groups
1023934|NCT00760526|B2|Baseline|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
1023935|NCT00760526|B1|Baseline|Continuous Glucose Montoring|Treatment group
1023936|NCT00760526|P2|Participant Flow|Standard Glucose Monitoring With Home Glucose Meter|Participants in the control group were given a FreeStyle Flash blood glucose meter and test strips and asked to perform blood glucose monitoring at least four times daily. Parents were provided with detailed instructions on how to use CGM and meter data to make real-time insulin dose adjustments and on using computer software to retrospectively review the glucose data to alter insulin dosing (if available). Target glucose values were 80-150 mg/dL before meals, 200 mg/dL after meals, 100-150 mg/dL at bedtime, and 80-150 mg/dL overnight.
1023973|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
1023974|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
1023937|NCT00760526|P1|Participant Flow|Continuous Glucose Montoring|Participants randomized to the CGM (treatment) group were provided with an unblinded CGM device, sensors, and a FreeStyle Flash blood glucose meter and test strips. A Free- Style Navigator was provided unless the participant was already using a Medtronic Paradigm insulin pump, in which case a MiniMed MiniLink REAL-Time Transmitter could be used. Parents were instructed on device use and daily sensor use was encouraged. They were instructed to continue testing with the home blood glucose meter >=4 times/day and to verify the accuracy of the CGM glucose measurement with the meter before making management decisions. Parents were provided with detailed instructions on how to use CGM and meter data to make real-time insulin dose adjustments and on using computer software to retrospectively review the glucose data to alter insulin dosing (if available). Target glucose values were 80-150 mg/dL before meals, 200 mg/dL after meals, 100-150 mg/dL at bedtime, and 80-150 mg/dL overnight.
1023938|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group: CGM Satisfaction
1023939|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group: Blood Glucose Monitoring System Rating Scale
1023940|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group: Blood Glucose Monitoring System Rating Scale
1023941|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group: PAID
1023942|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group: PAID
1023943|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group: Hypoglycemia Fear Survey
1023944|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group: Hypoglycemia Fear Survey
1023945|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
1023946|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group
1023947|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
1023948|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group
1023949|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
1023950|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group
1023951|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
1023952|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group
1023953|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
1023954|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group
1023955|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
1023956|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group
1023957|NCT00760526|O2|Outcome|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
1023958|NCT00760526|O1|Outcome|Continuous Glucose Montoring|Treatment group
1023959|NCT00760526|E2|Reported Event|Standard Glucose Monitoring With a Home Glucose Meter|Control Group
1023960|NCT00760526|E1|Reported Event|Continuous Glucose Montoring|Treatment group
1023961|NCT00760487|B1|Baseline|AcrySof Toric IOL|Implantation of the AcrySof Toric Intraocular lens (IOL)
1023962|NCT00760487|P1|Participant Flow|AcrySof Toric IOL|Implantation of the AcrySof Toric Intraocular lens (IOL)
1023963|NCT00760487|O1|Outcome|AcrySof Toric IOL|Implantation of the AcrySof Toric Intraocular lens (IOL)
1023964|NCT00760487|O1|Outcome|AcrySof Toric IOL|Implantation of the AcrySof Toric Intraocular lens (IOL)
1023965|NCT00760487|O1|Outcome|AcrySof Toric IOL|Implantation of the AcrySof Toric Intraocular lens (IOL)
1023966|NCT00760487|E1|Reported Event|AcrySof Toric IOL|Implantation of the AcrySof Toric Intraocular lens (IOL)
1023967|NCT00760474|B1|Baseline|Entire Study Population|"Participants who met entrance criteria received placebo for 1 week (Day 1 to 8) then were randomized in a 1:1 ratio to blinded treatment sequence to receive either:~Pregabalin, then placebo: Pregabalin 75 mg PO BID Period 1/Day 9 to 11; 150 mg BID Day 12 to 16; 200 mg BID Day 17 to 19; 225 mg BID Day 20 to 22 followed by taper Day 23 to 29 and an 8-day placebo washout period. Then, placebo matching study treatment in a similar pattern was administered beginning Period 2/Day 38 and included dose escalation through Day 51 followed by placebo taper Day 52 to 58.~Or placebo, then Pregabalin: Placebo matching study treatment was administered in a similar fashion to Pregabalin treatment beginning Period 1/Day 9 and included dose escalation, taper and an 8-day placebo washout period. Then, Pregabalin 75 mg BID Period 2/Day 38 to 40; 150 mg BID Day 41 to 45; 200 mg BID Day 46 to 48; 225 mg BID Day 49 to 51 followed by placebo taper Day 52 to 58."
1023968|NCT00760474|P2|Participant Flow|Placebo First, Then Pregabalin|Placebo matching study treatment was administered beginning Period 1/Day9. Then, Pregabalin 75 mg BID Period 2/Day 38 to 40; 150 mg BID Day 41 to 45; 200 mg BID Day 46 to 48; 225 mg BID Day 49 to 51 followed by placebo taper Day 52 to 58.
1023969|NCT00760474|P1|Participant Flow|Pregabalin First, Then Placebo|Pregabalin 75 milligrams (mg) by mouth (PO) twice daily (BID) Period 1/Day 9 to 11; 150 mg BID Day 12 to 16; 200 mg BID Day 17 to 19; 225 mg BID Day 20 to 22 followed by taper Day 23 to 29 and an 8-day placebo washout period. Then, placebo matching study treatment in a similar pattern was administered beginning Period 2/Day 38.
1023970|NCT00760474|O1|Outcome|All Study Treatment: Pregabalin, Placebo|"Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.~Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2."
1023971|NCT00760474|O1|Outcome|All Study Treatment: Pregabalin, Placebo|"Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.~Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2."
1023972|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
1024064|NCT00759941|B1|Baseline|Xalatan + Azopt|Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
1023975|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
1023976|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
1023977|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
1023978|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
1023979|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
1023980|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
1023981|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
1023982|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
1023983|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
1023984|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
1023985|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
1023986|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
1023987|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
1023988|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
1023989|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
1023990|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
1023991|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
1023992|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
1023993|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
1023994|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
1023995|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
1023996|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
1023997|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
1023998|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
1024165|NCT00759759|O1|Outcome|Morphine Sulfate 200 mg SR Capsules by Alpharma|
1023999|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
1024000|NCT00760474|O2|Outcome|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
1024001|NCT00760474|O1|Outcome|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
1024002|NCT00760474|E2|Reported Event|Placebo|Placebo to match study treatment administered in Period 1 or Placebo to match study treatment administered in Period 2.
1024003|NCT00760474|E1|Reported Event|Pregabalin|Pregabalin administered in Period 1 (75 mg BID Period 1/Day 9 to 11; then 150 mg BID Period 1/Day 12 to 16; then 200 mg BID Period 1/Day 17 to 19; then 225 mg BID Period 1/Day 20 to 22) or administered in Period 2 (75 mg BID Period 2/Day 38 to 40; then 150 mg BID Period 2/Day 41 to 45; then 200 mg BID Period 2/Day 46 to 48; then 225 mg BID Period 2/Day 49 to 51); then taper Period 2/Day 52 to 58.
1024004|NCT00760435|B3|Baseline|Total|Total of all reporting groups
1024005|NCT00760435|B2|Baseline|Placebo Arm|"98 received Placebo plus IVIG~Placebo: Placebo (same volume as active drug)"
1024006|NCT00760435|B1|Baseline|Infliximab Arm|"98 recieved infliximab plus IVIG~Infliximab: 5 mg/kg IV over 2 hours once"
1024007|NCT00760435|P2|Participant Flow|Placebo Arm|"98 received Placebo plus IVIG~Placebo: Placebo (same volume as active drug)"
1024008|NCT00760435|P1|Participant Flow|Infliximab Arm|"98 recieved infliximab plus IVIG~Infliximab: 5 mg/kg IV over 2 hours once"
1024009|NCT00760435|O2|Outcome|Placebo|97 subjects who received placebo + IVIG
1024010|NCT00760435|O1|Outcome|Infliximab|98 subjects treated with infliximab + IVIG
1024011|NCT00760435|O2|Outcome|Placebo|97 subjects who received placebo + IVIG
1024012|NCT00760435|O1|Outcome|Infliximab|98 subjects treated with infliximab + IVIG
1024013|NCT00760435|O2|Outcome|Placebo|97 subjects who received placebo + IVIG
1024014|NCT00760435|O1|Outcome|Infliximab|98 subjects treated with infliximab + IVIG
1024015|NCT00760435|O2|Outcome|Placebo|97 subjects who received placebo + IVIG
1024016|NCT00760435|O1|Outcome|Infliximab|98 subjects treated with infliximab + IVIG
1024017|NCT00760435|E2|Reported Event|Placebo Arm|"98 received Placebo plus IVIG~Placebo: Placebo (same volume as active drug)"
1024018|NCT00760435|E1|Reported Event|Infliximab Arm|"98 recieved infliximab plus IVIG~Infliximab: 5 mg/kg IV over 2 hours once"
1024019|NCT00760383|B3|Baseline|Total|Total of all reporting groups
1024020|NCT00760383|B2|Baseline|ALA+PT|"20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Alanine: Subjects will ingest 20 grams of non-essential amino acid (NEAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the NEAA supplement 30 minutes after the end of each PT rehabilitation session."
1024021|NCT00760383|B1|Baseline|EAA+PT|"20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Essential amino acids: Subjects will ingest 20 grams of essential amino acids (EAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the EAA supplement 30 minutes after the end of each PT rehabilitation session."
1024022|NCT00760383|P2|Participant Flow|ALA+PT|"20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Alanine: Subjects will ingest 20 grams of non-essential amino acid (NEAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the NEAA supplement 30 minutes after the end of each PT rehabilitation session."
1024023|NCT00760383|P1|Participant Flow|EAA+PT|"20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Essential amino acids: Subjects will ingest 20 grams of essential amino acids (EAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the EAA supplement 30 minutes after the end of each PT rehabilitation session."
1024024|NCT00760383|O2|Outcome|ALA+PT|"20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Alanine: Subjects will ingest 20 grams of non-essential amino acid (NEAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the NEAA supplement 30 minutes after the end of each PT rehabilitation session."
1024025|NCT00760383|O1|Outcome|EAA+PT|"20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Essential amino acids: Subjects will ingest 20 grams of essential amino acids (EAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the EAA supplement 30 minutes after the end of each PT rehabilitation session."
1024026|NCT00760383|O2|Outcome|ALA+PT|"20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Alanine: Subjects will ingest 20 grams of non-essential amino acid (NEAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the NEAA supplement 30 minutes after the end of each PT rehabilitation session."
1024027|NCT00760383|O1|Outcome|EAA+PT|"20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Essential amino acids: Subjects will ingest 20 grams of essential amino acids (EAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the EAA supplement 30 minutes after the end of each PT rehabilitation session."
1024028|NCT00760383|O2|Outcome|ALA+PT|"20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Alanine: Subjects will ingest 20 grams of non-essential amino acid (NEAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the NEAA supplement 30 minutes after the end of each PT rehabilitation session."
1024029|NCT00760383|O1|Outcome|EAA+PT|"20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Essential amino acids: Subjects will ingest 20 grams of essential amino acids (EAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the EAA supplement 30 minutes after the end of each PT rehabilitation session."
1024030|NCT00760383|E2|Reported Event|ALA+PT|"20 g NEAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Alanine: Subjects will ingest 20 grams of non-essential amino acid (NEAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the NEAA supplement 30 minutes after the end of each PT rehabilitation session."
1024031|NCT00760383|E1|Reported Event|EAA+PT|"20 g EAA daily for 7 days prior to TKA surgery and for 14 days after surgery.~Essential amino acids: Subjects will ingest 20 grams of essential amino acids (EAA) daily for 7 days prior to total knee arthroplasty (TKA) surgery and for 14 days after surgery daily. On the days they are seen by physical therapy (PT) they will ingest the EAA supplement 30 minutes after the end of each PT rehabilitation session."
1024032|NCT00760084|B1|Baseline|Decitabine|Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks.
1024033|NCT00760084|P1|Participant Flow|Decitabine|Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks.
1024034|NCT00760084|O1|Outcome|Decitabine|Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks.
1024035|NCT00760084|E1|Reported Event|Decitabine|Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks.
1024036|NCT00760019|B3|Baseline|Total|Total of all reporting groups
1024037|NCT00760019|B2|Baseline|Healthy|"Participant flow is identical to that of NCT00762827 (The Impact of Reducing Inflammation on Vascular Function in the Metabolic Syndrome):~The study arms reflect the randomized, placebo-controlled, double-blinded crossover design of the study. In this control arm, healthy individuals received either 4.5 g/day salsalate or matching placebo for a 4-week long period. After a 4-week washout interval, these individuals crossed over and received either the salsalate or the placebo (whichever they did not receive in the first study period) for another 4 weeks."
1024038|NCT00760019|B1|Baseline|Atherosclerosis or Metabolic Syndrome|"Participant flow is identical to that of NCT00762827 (The Impact of Reducing Inflammation on Vascular Function in the Metabolic Syndrome):~The study arms reflect the randomized, placebo-controlled, double-blinded crossover design of the study. In this arm, individuals with either Metabolic Syndrome or Atherosclerosis received either 4.5 g/day salsalate or matching placebo for a 4-week long period. After a 4-week washout interval, these individuals crossed over and received either the salsalate or the placebo (whichever they did not receive in the first study period) for another 4 weeks."
1024039|NCT00760019|P4|Participant Flow|Healthy Subjects: Placebo First, Then Salsalate|Healthy subjects received placebo for 4 weeks, washout for 4 weeks, and 4.5 g/day salsalate for 4 weeks.
1024040|NCT00760019|P3|Participant Flow|Healthy Subjects: Salsalate First, Then Placebo|Healthy subjects received either 4.5 g/day salsalate for 4 weeks, washout for 4 weeks, and matching placebo for 4 weeks.
1024041|NCT00760019|P2|Participant Flow|Atherosclerosis/Metabolic Syndrome: Placebo First, Then Salsal|Subjects with either Metabolic Syndrome/Atherosclerosis received placebo for 4 weeks, washout for 4 weeks, and 4.5 g/day salsalate for 4 weeks.
1024042|NCT00760019|P1|Participant Flow|Atherosclerosis/Metabolic Syndrome: Salsalate First, Then Plac|Subjects with either Metabolic Syndrome/Atherosclerosis received either 4.5 g/day salsalate for 4 weeks, washout for 4 weeks, and matching placebo for 4 weeks.
1024043|NCT00760019|O2|Outcome|Placebo|Outcomes were measured at the end of each 4-week study period. Here, median flow-mediated, endothelium-dependent vasodilation after 4 weeks of 4.5 g/day salsalate is compared with median FMD after 4 weeks of matching placebo. Data represent all subjects: those with atherosclerosis/metabolic syndrome as well as healthy controls.
1024044|NCT00760019|O1|Outcome|Salsalate|Outcomes were measured at the end of each 4-week study period. Here, median flow-mediated, endothelium-dependent vasodilation after 4 weeks of 4.5 g/day salsalate is compared with median FMD after 4 weeks of matching placebo. Data represent all subjects: those with atherosclerosis/metabolic syndrome as well as healthy controls.
1024045|NCT00760019|E2|Reported Event|Placebo|Adverse Event Data represent all subjects: those with atherosclerosis/metabolic syndrome as well as healthy controls that received Placebo
1024046|NCT00760019|E1|Reported Event|Salsalate|Adverse Event Data represent all subjects: those with atherosclerosis/metabolic syndrome as well as healthy controls that received Salsalate
1024047|NCT00759954|B3|Baseline|Total|Total of all reporting groups
1024048|NCT00759954|B2|Baseline|Period 2: Treatment Aor B|Treatment B (reference product)followed by Treatment A (test product)
1024049|NCT00759954|B1|Baseline|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
1024050|NCT00759954|P2|Participant Flow|Period 2: Treatment Aor B|Treatment B (reference product)followed by Treatment A (test product)
1024051|NCT00759954|P1|Participant Flow|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
1024052|NCT00759954|O2|Outcome|KADIAN® 2 × 100 mg Caps by Alpharma|
1024053|NCT00759954|O1|Outcome|Morphine Sulfate 200 mg SR Caps by Alpharma|
1024054|NCT00759954|O2|Outcome|KADIAN® 2 × 100 mg Caps by Alpharma|
1024055|NCT00759954|O1|Outcome|Morphine Sulfate 200 mg SR Caps by Alpharma|
1024056|NCT00759954|O2|Outcome|KADIAN® 2 × 100 mg Caps by Alpharma|
1024057|NCT00759954|O1|Outcome|Morphine Sulfate 200 mg SR Caps by Alpharma|
1024058|NCT00759954|O2|Outcome|KADIAN® 2 × 100 mg Caps by Alpharma|
1024059|NCT00759954|O1|Outcome|Morphine Sulfate 200 mg SR Caps by Alpharma|
1024060|NCT00759954|E2|Reported Event|Arm 2: Treatment B Followed by Treatment A|
1024061|NCT00759954|E1|Reported Event|Arm 1: Treatment A Followed by Treatment B|
1024062|NCT00759941|B3|Baseline|Total|Total of all reporting groups
1024063|NCT00759941|B2|Baseline|Xalatan + Placebo|Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
1025140|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1024065|NCT00759941|P2|Participant Flow|Xalatan + Placebo|Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
1024066|NCT00759941|P1|Participant Flow|Xalatan + Azopt|Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
1024067|NCT00759941|O2|Outcome|Xalatan + Placebo|Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
1024068|NCT00759941|O1|Outcome|Xalatan + Azopt|Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
1024069|NCT00759941|O2|Outcome|Xalatan + Placebo|Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
1024070|NCT00759941|O1|Outcome|Xalatan + Azopt|Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
1024071|NCT00759941|O2|Outcome|Xalatan + Placebo|Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
1024072|NCT00759941|O1|Outcome|Xalatan + Azopt|Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
1024073|NCT00759941|O2|Outcome|Xalatan + Placebo|Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
1024074|NCT00759941|O1|Outcome|Xalatan + Azopt|Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
1024075|NCT00759941|E2|Reported Event|Xalatan + Placebo|Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
1024076|NCT00759941|E1|Reported Event|Xalatan + Azopt|Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
1024077|NCT00759915|B3|Baseline|Total|Total of all reporting groups
1024078|NCT00759915|B2|Baseline|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
1024079|NCT00759915|B1|Baseline|Period 1: Treatment Aor B|Treatment A (test product) followed by Treatment B (reference product)
1024080|NCT00759915|P2|Participant Flow|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
1024081|NCT00759915|P1|Participant Flow|Period 1: Treatment Aor B|Treatment A (test product) followed by Treatment B (reference product)
1024082|NCT00759915|O2|Outcome|KADIAN 20mg Capsules|
1024083|NCT00759915|O1|Outcome|KADIAN (2 x 10mg) Capsules|
1024084|NCT00759915|O2|Outcome|KADIAN 20mg Capsules|
1024085|NCT00759915|O1|Outcome|KADIAN (2 x 10mg) Capsules|
1024086|NCT00759915|O2|Outcome|KADIAN 20mg Capsules|
1024087|NCT00759915|O1|Outcome|KADIAN (2 x 10mg) Capsules|
1024088|NCT00759915|O2|Outcome|KADIAN 20mg Capsules|
1024089|NCT00759915|O1|Outcome|KADIAN (2 x 10mg) Capsules|
1024090|NCT00759915|E2|Reported Event|Arm 2: Treatment B Followed by Treatment A|
1024091|NCT00759915|E1|Reported Event|Arm 1: Treatment A Followed by Treatment B|
1024092|NCT00759902|B3|Baseline|Total|Total of all reporting groups
1024093|NCT00759902|B2|Baseline|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
1024094|NCT00759902|B1|Baseline|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
1024095|NCT00759902|P2|Participant Flow|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
1024096|NCT00759902|P1|Participant Flow|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
1024097|NCT00759902|O2|Outcome|KADIAN 20 mg Capsules|1 x 20 mg KADIAN capsules
1024098|NCT00759902|O1|Outcome|KADIAN 10 mg Capsules|2 x 10 mg KADIAN capsules
1024099|NCT00759902|O2|Outcome|KADIAN 20 mg Capsules|1 x 20 mg KADIAN capsules
1024100|NCT00759902|O1|Outcome|KADIAN 10 mg Capsules|2 x 10 mg KADIAN capsules
1024101|NCT00759902|O2|Outcome|KADIAN 20 mg Capsules|1 x 20 mg KADIAN capsules
1024102|NCT00759902|O1|Outcome|KADIAN 10 mg Capsules|2 x 10 mg KADIAN capsules
1024103|NCT00759902|O2|Outcome|KADIAN 20 mg Capsules|1 x 20 mg KADIAN capsules
1024104|NCT00759902|O1|Outcome|KADIAN 10 mg Capsules|2 x 10 mg KADIAN capsules
1024105|NCT00759902|E2|Reported Event|Arm 2: Treatment B Followed by Treatment A|
1024106|NCT00759902|E1|Reported Event|Arm 1: Treatment A Followed by Treatment B|
1024107|NCT00759863|B3|Baseline|Total|Total of all reporting groups
1024108|NCT00759863|B2|Baseline|Usual Care|Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
1024109|NCT00759863|B1|Baseline|Lifezig|Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
1024110|NCT00759863|P2|Participant Flow|Usual Care|Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
1024111|NCT00759863|P1|Participant Flow|Lifezig|Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
1024112|NCT00759863|O2|Outcome|Usual Care|Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
1024113|NCT00759863|O1|Outcome|Lifezig|Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
1024114|NCT00759863|O2|Outcome|Usual Care|Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
1024115|NCT00759863|O1|Outcome|Lifezig|Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
1024166|NCT00759759|E2|Reported Event|Arm 2: Treatment B Followed by Treatment A|
1024116|NCT00759863|O2|Outcome|Usual Care|Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
1024117|NCT00759863|O1|Outcome|Lifezig|Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
1024118|NCT00759863|E2|Reported Event|Usual Care|Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities.
1024119|NCT00759863|E1|Reported Event|Lifezig|Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system)
1024120|NCT00759811|B3|Baseline|Total|Total of all reporting groups
1024121|NCT00759811|B2|Baseline|Placebo|Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks.
1024122|NCT00759811|B1|Baseline|Methotrexate|Patients receiving conventional treatment to heart failure who will receive methotrexate 7.5mg oral plus folic acid 5mg oral once a week for 12 weeks.
1024123|NCT00759811|P2|Participant Flow|Placebo|Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks.
1024124|NCT00759811|P1|Participant Flow|Methotrexate|Patients receiving conventional treatment to heart failure who will receive methotrexate 7.5mg oral plus folic acid 5mg oral once a week for 12 weeks.
1024125|NCT00759811|O2|Outcome|Placebo|Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks.
1024126|NCT00759811|O1|Outcome|Methotrexate|Patients receiving conventional treatment to heart failure who will receive methotrexate 7.5mg oral plus folic acid 5mg oral once a week for 12 weeks.
1024127|NCT00759811|E2|Reported Event|Placebo|Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks.
1024128|NCT00759811|E1|Reported Event|Methotrexate|Patients receiving conventional treatment to heart failure who will receive methotrexate 7.5mg oral plus folic acid 5mg oral once a week for 12 weeks.
1024129|NCT00759785|B3|Baseline|Total|Total of all reporting groups
1024130|NCT00759785|B2|Baseline|Triple Negative (TN)|Triple Negative participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
1024131|NCT00759785|B1|Baseline|ER-positive Luminal B (ER+)|ER-positive Luminal B participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
1024132|NCT00759785|P2|Participant Flow|Triple Negative (TN)|Triple Negative participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
1024133|NCT00759785|P1|Participant Flow|ER-positive Luminal B (ER+)|ER-positive Luminal B participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
1024134|NCT00759785|O2|Outcome|Triple Negative (TN)|Triple Negative participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
1024135|NCT00759785|O1|Outcome|ER-positive Luminal B (ER+)|ER-positive Luminal B participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
1024136|NCT00759785|O2|Outcome|Triple Negative (TN)|Triple Negative participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
1024137|NCT00759785|O1|Outcome|ER-positive Luminal B (ER+)|ER-positive Luminal B participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
1024138|NCT00759785|O2|Outcome|Triple Negative (TN)|Triple Negative participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
1024139|NCT00759785|O1|Outcome|ER-positive Luminal B (ER+)|ER-positive Luminal B participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
1024140|NCT00759785|O2|Outcome|Triple Negative (TN)|Triple Negative participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
1024141|NCT00759785|O1|Outcome|ER-positive Luminal B (ER+)|ER-positive Luminal B participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
1024142|NCT00759785|E2|Reported Event|Triple Negative (TN)|Triple Negative participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
1024143|NCT00759785|E1|Reported Event|ER-positive Luminal B (ER+)|ER-positive Luminal B participants received a single dose of dalotuzumab 20 mg/kg infused over 60-120 minutes.
1024144|NCT00759772|B3|Baseline|Total|Total of all reporting groups
1024145|NCT00759772|B2|Baseline|Placebo|Placebo: Placebo 20 mcg sc daily for 6 months
1024146|NCT00759772|B1|Baseline|Teriparatide|Teriparatide: Teriparatide 20 mcg sc daily for 6 months
1024147|NCT00759772|P2|Participant Flow|Placebo|Placebo: Placebo 20 mcg sc daily for 6 months
1024148|NCT00759772|P1|Participant Flow|Teriparatide|Teriparatide: Teriparatide 20 mcg sc daily for 6 months
1024149|NCT00759772|O2|Outcome|Placebo|Placebo: Placebo 20 mcg sc daily for 6 months
1024150|NCT00759772|O1|Outcome|Teriparatide|Teriparatide: Teriparatide 20 mcg sc daily for 6 months
1024151|NCT00759772|E2|Reported Event|Placebo|Placebo: Placebo 20 mcg sc daily for 6 months
1024152|NCT00759772|E1|Reported Event|Teriparatide|Teriparatide: Teriparatide 20 mcg sc daily for 6 months
1024153|NCT00759759|B3|Baseline|Total|Total of all reporting groups
1024154|NCT00759759|B2|Baseline|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
1024155|NCT00759759|B1|Baseline|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
1024156|NCT00759759|P2|Participant Flow|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
1024157|NCT00759759|P1|Participant Flow|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
1024158|NCT00759759|O2|Outcome|KADIAN® 100mg Caps by Alpharma|
1024159|NCT00759759|O1|Outcome|Morphine Sulfate 200 mg SR Capsules by Alpharma|
1024160|NCT00759759|O2|Outcome|KADIAN® 100mg Caps by Alpharma|
1024161|NCT00759759|O1|Outcome|Morphine Sulfate 200 mg SR Capsules by Alpharma|
1024162|NCT00759759|O2|Outcome|KADIAN® 100mg Caps by Alpharma|
1024163|NCT00759759|O1|Outcome|Morphine Sulfate 200 mg SR Capsules by Alpharma|
1024164|NCT00759759|O2|Outcome|KADIAN® 100mg Caps by Alpharma|
1024167|NCT00759759|E1|Reported Event|Arm 1: Treatment A Followed by Treatment B|
1024168|NCT00759707|B1|Baseline|Study Population|All 19 study subjects had continuously patent femoral-to-popliteal arterial bypass with autogenous greater saphenous vein. Ultrasound imaging of saphenous vein bypass graft followed an ischemic stimulus and administration of sublingual nitroglycerin. In the last 6 consecutive subjects, L-N^G monomethyl arginine (L-NMMA) was administered intravenously.
1024169|NCT00759707|P1|Participant Flow|Study Population|All 19 study subjects had continuously patent femoral-to-popliteal arterial bypass with autogenous greater saphenous vein. Ultrasound imaging of saphenous vein bypass graft followed an ischemic stimulus and administration of sublingual nitroglycerin. In the last 6 consecutive subjects, L-N^G monomethyl arginine (L-NMMA) was administered intravenously.
1024170|NCT00759707|O1|Outcome|Study Population|All 19 study subjects had continuously patent femoral-to-popliteal arterial bypass with autogenous greater saphenous vein. Ultrasound imaging of saphenous vein bypass graft followed an ischemic stimulus and administration of sublingual nitroglycerin. In the last 6 consecutive subjects, L-N^G monomethyl arginine (L-NMMA) was administered intravenously.
1024171|NCT00759707|E1|Reported Event|Study Population|All 19 study subjects. Each subject qualified for the study on the basis of a continuously patent femoral-to-popliteal arterial bypass with autogenous greater saphenous vein.
1024172|NCT00759681|B3|Baseline|Total|Total of all reporting groups
1024173|NCT00759681|B2|Baseline|Investigational Device|Investigational Treatment: ArterX Surgical Sealant
1024174|NCT00759681|B1|Baseline|Control|Control Treatment: Gelfoam and Thrombin
1024175|NCT00759681|P2|Participant Flow|Investigational Device: ArterX Surgical Sealant|ArterX is a two-component sealant provided in a double barreled syringe. The main components are bovine serum albumin and a polyaldehyde formed from polymerized glutaraldehyde. The solutions are dispensed through a double plunger, mixing the two components in a 1:1 ratio by passing them through a specially designed mixing tip, delivering up to 2 ml volume of each component.
1024176|NCT00759681|P1|Participant Flow|Control: Gelfoam and Thrombin|Gelfoam PlusTM is used to seal suture lines of arterial grafts or patches made from PTFE and Dacron. Gelfoam is a sterile compressed sponge and Thrombin is the last enzyme in the clotting cascade.
1024177|NCT00759681|O2|Outcome|Investigational Device|Investigational Device: ArterX Surgical Sealant
1024178|NCT00759681|O1|Outcome|Control Treatment|Control Treatment with Gelfoam and Thrombin
1024179|NCT00759681|O2|Outcome|Investigational Device|Investigational Device: ArterX Surgical Sealant
1024180|NCT00759681|O1|Outcome|Control Treatment|Control Treatment: Gelfoam and Thrombin
1024181|NCT00759681|E2|Reported Event|1. ArterX Surgical Sealant|ArterX Surgical Sealant
1024182|NCT00759681|E1|Reported Event|2. Gelfoam and Thrombin|Gelfoam and Thrombin
1024183|NCT00759668|B3|Baseline|Total|Total of all reporting groups
1024184|NCT00759668|B2|Baseline|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
1024185|NCT00759668|B1|Baseline|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
1024186|NCT00759668|P2|Participant Flow|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
1024187|NCT00759668|P1|Participant Flow|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
1024188|NCT00759668|O2|Outcome|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
1024189|NCT00759668|O1|Outcome|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
1024190|NCT00759668|O2|Outcome|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
1024191|NCT00759668|O1|Outcome|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
1024192|NCT00759668|O2|Outcome|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
1024193|NCT00759668|O1|Outcome|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
1024194|NCT00759668|O2|Outcome|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
1024195|NCT00759668|O1|Outcome|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
1024196|NCT00759668|O2|Outcome|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
1024197|NCT00759668|O1|Outcome|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
1024198|NCT00759668|O2|Outcome|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
1024199|NCT00759668|O1|Outcome|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
1024200|NCT00759668|E2|Reported Event|SN60AT|Intraocular Lens Acrysof Natural Monofocal SN60AT
1024201|NCT00759668|E1|Reported Event|SN60D3|Intraocular Lens Acrysof Natural Restor SN60D3
1024202|NCT00759655|B1|Baseline|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
1024203|NCT00759655|P1|Participant Flow|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
1024204|NCT00759655|O1|Outcome|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
1024205|NCT00759655|O1|Outcome|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
1024206|NCT00759655|O1|Outcome|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
1024207|NCT00759655|O1|Outcome|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
1024208|NCT00759655|O1|Outcome|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
1024209|NCT00759655|O1|Outcome|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
1024210|NCT00759655|O1|Outcome|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
1024211|NCT00759655|O1|Outcome|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
1024212|NCT00759655|E1|Reported Event|Xyntha|Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician.
1024213|NCT00759642|B1|Baseline|Lapatinib|"lapatinib~lapatinib: lapatinib 1500 mg PO daily"
1024214|NCT00759642|P1|Participant Flow|Lapatinib|"lapatinib + Endocrine therapy (will continue prior antihormone therapy, on which progression was noted)~lapatinib: lapatinib 1500 mg PO daily"
1024215|NCT00759642|O1|Outcome|Lapatinib|"lapatinib + Endocrine therapy~lapatinib: lapatinib 1500 mg PO daily"
1024216|NCT00759642|E1|Reported Event|Lapatinib|"lapatinib + Endocrine therapy (will continue prior antihormone therapy, on which progression was noted)~lapatinib: lapatinib 1500 mg PO daily"
1024217|NCT00759603|B1|Baseline|Lenalidomide + Rituximab|Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.
1024218|NCT00759603|P1|Participant Flow|Lenalidomide + Rituximab|Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.
1024219|NCT00759603|O1|Outcome|Lenalidomide + Rituximab|Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.
1024220|NCT00759603|E1|Reported Event|Lenalidomide + Rituximab|Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.
1024221|NCT00759577|B1|Baseline|At Home Titration|"Starting with 5mg of solifenacin by mouth daily with self-titration (at home) up 10mg of solifenacin by mouth daily."
1024222|NCT00759577|P1|Participant Flow|At Home Titration|"Starting with 5mg of solifenacin by mouth daily with self-titration (at home) up 10mg of solifenacin by mouth daily."
1024223|NCT00759577|O1|Outcome|At Home Titration|"Starting with 5mg of solifenacin by mouth daily with self-titration (at home) up 10mg of solifenacin by mouth daily."
1024224|NCT00759577|E1|Reported Event|At Home Titration|"Starting with 5mg of solifenacin by mouth daily with self-titration (at home) up 10mg of solifenacin by mouth daily."
1024225|NCT00759564|B6|Baseline|Total|Total of all reporting groups
1024226|NCT00759564|B5|Baseline|CP-70,429 (200 mg) + PF-03709270: Severe Renal Function|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-­70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF­-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
1024227|NCT00759564|B4|Baseline|CP-70,429 (800 mg) + PF-03709270: Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
1024228|NCT00759564|B3|Baseline|CP-70,429 (800 mg) + PF-03709270: Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr greater than or equal to >=30 and <=50 mL/min) received a single dose of CP­-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
1024229|NCT00759564|B2|Baseline|CP-70,429 (800 mg) + PF-03709270: Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and less than or equal to [<=] 80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
1024230|NCT00759564|B1|Baseline|CP-70,429 (800 mg) + PF-03709270: Normal Renal Impairment|Participants with normal renal function (defined by creatinine clearance [CLcr] greater than [>] 80 milliliter per minute [mL/min]) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
1024231|NCT00759564|P5|Participant Flow|CP-70,429 (200 mg) + PF-03709270: Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-­70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF­-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
1024232|NCT00759564|P4|Participant Flow|CP-70,429 (800 mg) + PF-03709270: Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
1024233|NCT00759564|P3|Participant Flow|CP-70,429 (800 mg) + PF-03709270: Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr greater than or equal to >=30 and <=50 mL/min) received a single dose of CP­-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
1024234|NCT00759564|P2|Participant Flow|CP-70,429 (800 mg) + PF-03709270: Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and less than or equal to [<=] 80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
1024235|NCT00759564|P1|Participant Flow|CP-70,429 (800 mg) + PF-03709270: Normal Renal Function|Participants with normal renal function (defined by creatinine clearance [CLcr] greater than [>] 80 milliliter per minute [mL/min]) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
1024236|NCT00759564|O9|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024237|NCT00759564|O8|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024238|NCT00759564|O7|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024239|NCT00759564|O6|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024240|NCT00759564|O5|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024241|NCT00759564|O4|Outcome|CP-70,429 (800 mg): Severe Renal Impairment|Participants with severe renal impairment received a single dose of CP-70,429 800 mg given as a 1.5-hour intravenous infusion under fasted condition in first intervention period.
1024242|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024243|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024244|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024245|NCT00759564|O9|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024246|NCT00759564|O8|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024247|NCT00759564|O7|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024248|NCT00759564|O6|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024249|NCT00759564|O5|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024250|NCT00759564|O4|Outcome|CP-70,429 (800 mg): Severe Renal Impairment|Participants with severe renal impairment received a single dose of CP-70,429 800 mg given as a 1.5-hour intravenous infusion under fasted condition in first intervention period.
1024251|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024252|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024253|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024254|NCT00759564|O9|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024255|NCT00759564|O8|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024256|NCT00759564|O7|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024257|NCT00759564|O6|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024258|NCT00759564|O5|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024259|NCT00759564|O4|Outcome|CP-70,429 (800 mg): Severe Renal Impairment|Participants with severe renal impairment received a single dose of CP-70,429 800 mg given as a 1.5-hour intravenous infusion under fasted condition in first intervention period.
1024260|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024261|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024262|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024263|NCT00759564|O9|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024264|NCT00759564|O8|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024265|NCT00759564|O7|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024266|NCT00759564|O6|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024267|NCT00759564|O5|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024268|NCT00759564|O4|Outcome|CP-70,429 (800 mg): Severe Renal Impairment|Participants with severe renal impairment received a single dose of CP-70,429 800 mg given as a 1.5-hour intravenous infusion under fasted condition in first intervention period.
1024269|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024270|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024271|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024272|NCT00759564|O9|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024273|NCT00759564|O8|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024274|NCT00759564|O7|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024275|NCT00759564|O6|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024276|NCT00759564|O5|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024277|NCT00759564|O4|Outcome|CP-70,429 (800 mg): Severe Renal Impairment|Participants with severe renal impairment received a single dose of CP-70,429 800 mg given as a 1.5-hour intravenous infusion under fasted condition in first intervention period.
1024278|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024279|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024280|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024281|NCT00759564|O4|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024282|NCT00759564|O3|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024283|NCT00759564|O2|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024284|NCT00759564|O1|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024285|NCT00759564|O4|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024286|NCT00759564|O3|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024287|NCT00759564|O2|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024288|NCT00759564|O1|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024289|NCT00759564|O4|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024290|NCT00759564|O3|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024291|NCT00759564|O2|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024376|NCT00759525|P1|Participant Flow|Glycyrrhetinic Acid First, Then Placebo|Glycyrrhetic Acid-130 mg/day for 14 days followed by placebo
1024292|NCT00759564|O1|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024293|NCT00759564|O4|Outcome|PF-­03709270: Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
1024294|NCT00759564|O3|Outcome|PF­-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
1024295|NCT00759564|O2|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024296|NCT00759564|O1|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024297|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024298|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024299|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024300|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024301|NCT00759564|O4|Outcome|PF-­03709270: Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
1024302|NCT00759564|O3|Outcome|PF­-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
1024303|NCT00759564|O2|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024304|NCT00759564|O1|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024305|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024306|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024307|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024308|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024309|NCT00759564|O4|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024310|NCT00759564|O3|Outcome|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024311|NCT00759564|O2|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024312|NCT00759564|O1|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024313|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024314|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024315|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024316|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024317|NCT00759564|O4|Outcome|PF-­03709270: Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
1024318|NCT00759564|O3|Outcome|PF­-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
1024319|NCT00759564|O2|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024320|NCT00759564|O1|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024321|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024322|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024323|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024324|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024325|NCT00759564|O4|Outcome|PF-­03709270: Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
1024326|NCT00759564|O3|Outcome|PF­-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
1024327|NCT00759564|O2|Outcome|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024328|NCT00759564|O1|Outcome|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024329|NCT00759564|O4|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024330|NCT00759564|O3|Outcome|PF­-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
1024331|NCT00759564|O2|Outcome|PF­-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024332|NCT00759564|O1|Outcome|PF-­03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
1024333|NCT00759564|O4|Outcome|PF-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024334|NCT00759564|O3|Outcome|PF-­03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
1024335|NCT00759564|O2|Outcome|PF­-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF­03709270 1000 mg tablet in second intervention period.
1024336|NCT00759564|O1|Outcome|PF­03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
1024337|NCT00759564|O4|Outcome|PF­-03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
1024338|NCT00759564|O3|Outcome|PF-­03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
1024339|NCT00759564|O2|Outcome|PF­-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024340|NCT00759564|O1|Outcome|PF-­03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
1024341|NCT00759564|O4|Outcome|PF-­03709270 (1000 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
1024342|NCT00759564|O3|Outcome|PF-­03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
1024343|NCT00759564|O2|Outcome|PF-­03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
1024344|NCT00759564|O1|Outcome|PF-­03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
1024345|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024346|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024347|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024547|NCT00759109|O2|Outcome|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
1024348|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024349|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024350|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024351|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024352|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024353|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024354|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024355|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024356|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024357|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024358|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024359|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024360|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024361|NCT00759564|O4|Outcome|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024362|NCT00759564|O3|Outcome|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024363|NCT00759564|O2|Outcome|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024364|NCT00759564|O1|Outcome|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024365|NCT00759564|E9|Reported Event|PF-03709270 (1000 mg): Severe Renal|Participants with severe renal impairment received a single oral dose of PF-03709270 1000 mg tablet under fasted condition in second intervention period.
1024366|NCT00759564|E8|Reported Event|PF-03709270 (1000 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024367|NCT00759564|E7|Reported Event|PF-03709270 (1000 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024368|NCT00759564|E6|Reported Event|PF-03709270 (1000 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
1024369|NCT00759564|E5|Reported Event|CP-70,429 (200 mg): Severe Renal Impairment|Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024370|NCT00759564|E4|Reported Event|CP-70,429 (800 mg): Severe Renal Impairment|Participants with severe renal impairment received a single dose of CP-70,429 800 mg given as a 1.5-hour intravenous infusion under fasted condition in first intervention period.
1024371|NCT00759564|E3|Reported Event|CP-70,429 (800 mg): Moderate Renal Impairment|Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024372|NCT00759564|E2|Reported Event|CP-70,429 (800 mg): Mild Renal Impairment|Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024373|NCT00759564|E1|Reported Event|CP-70,429 (800 mg): Normal Renal Function|Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
1024374|NCT00759525|B1|Baseline|All Study Participants|
1024375|NCT00759525|P2|Participant Flow|Placebo First, Then Glycyrrhetinic Acid|Placebo followed by Glycyrrhetic Acid-130 mg/day for 14 days
1024377|NCT00759525|O2|Outcome|Placebo|All of the 15 subjects received both glycyrrhinitic acid (130mg/day) (GA) for a 14-day period and placebo for a 14-day period. Approximately half of the subjects received GA before placebo; the other half received placebo before GA. There was a 2-week washout period between the two conditions.
1024378|NCT00759525|O1|Outcome|Glycyrrhinitic Acid|All of the 15 subjects received both glycyrrhinitic acid (130mg/day) (GA) for a 14-day period and placebo for a 14-day period. Approximately half of the subjects received GA before placebo; the other half received placebo before GA. There was a 2-week washout period between the two conditions.
1024379|NCT00759525|E2|Reported Event|Placebo First, Then Glycyrrhetinic Acid|Healthy subjects without medical condition.
1024380|NCT00759525|E1|Reported Event|Glycyrrhetinic Acid First, Then Placebo|Healthy subjects without medical condition.
1024381|NCT00759473|B6|Baseline|Total|Total of all reporting groups
1024382|NCT00759473|B5|Baseline|Placebo/Placebo/Placebo|Participants were assigned to receive placebo at 2 cue expsosure sessions, and at the one-week follow-up session. Participants also received cognitive skills training.During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities. Cue exposure was accompanied by instructions on how to cope with craving.
1024383|NCT00759473|B4|Baseline|DCS /DCS/Placebo|Participants were assigned to receive 50 mg of DCS at 2 cue exposure sessions, and placebo at the one-week follow-up session. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities. Cue exposure was accompanied by instructions on how to cope with craving.
1024384|NCT00759473|B3|Baseline|DCS/ Placebo/DCS/Placebo|Participants were assigned to receive 50 mg of DCS at the 1st and 3rd cue sessions and placebo at the 2nd cue session and the one-week follow-up session.During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.
1024385|NCT00759473|B2|Baseline|Placebo/Placebo/Placebo/Placebo|Participants were assigned to receive a placebo for each of 3 cue exposure sessions and at the one-week follow-up session.During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.
1024386|NCT00759473|B1|Baseline|DCS/DCS/DCS/Placebo|Participants were assigned to receive 50 mg of DCS for each of 3 cue exposure sessions and a placebo at the one-week follow-up session.During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.
1024387|NCT00759473|P5|Participant Flow|Placebo/Placebo/Placebo|Participants were assigned to receive placebo at 2 cue exposure sessions, and at the one-week follow-up session. Participants also received cognitive skills training. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities. Cue exposure was accompanied by instructions on how to cope with craving.
1024388|NCT00759473|P4|Participant Flow|DCS/DCS/Placebo|Participants were assigned to receive 50 mg of d-cycloserine (DCS) at 2 cue cue exposure sessions, and placebo at the one-week follow-up session. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities. Cue exposure was accompanied by instructions on how to cope with craving.
1024389|NCT00759473|P3|Participant Flow|DCS/ Placebo/DCS/Placebo|Participants were assigned to receive 50 mg of d-cycloserine (DCS) at the 1st and 3rd cue sessions and placebo at the 2nd cue session and the one-week follow-up session. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.
1024390|NCT00759473|P2|Participant Flow|Placebo/Placebo/Placebo/Placebo|Participants were assigned to receive a placebo for each of 3 cue exposure sessions and at the one-week follow-up session.During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.
1024391|NCT00759473|P1|Participant Flow|DCS/DCS/DCS/ Placebo|Participants were assigned to receive 50 mg of d-cycloserine (DCS) for each of 3 cue exposure sessions and a placebo at the one-week follow-up session. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.
1024392|NCT00759473|O5|Outcome|Placebo Plus Cognitive Skills Training|Participants received a placebo at 2 cue extinction sessions and at the one-week follow-up session. Participants also received cognitive skills training.
1024393|NCT00759473|O4|Outcome|DCS Plus Cognitive Skills Training|Participants received 50 mg of DCS at 2 cue extinction sessions and placebo at the one-week follow-up session. Participants also received cognitive skills training.
1024394|NCT00759473|O3|Outcome|DCS/ Placebo/DCS|Participants received 50 mg of DCS at the 1st and 3rd cue exposure sessions, and placebo at the 2nd cue exposure session and the one-week follow-up session.
1024395|NCT00759473|O2|Outcome|Placebo Only|Participants received a placebo at each of 3 cue exposure sessions and at the one-week follow-up session.
1024396|NCT00759473|O1|Outcome|DCS Only|Participants received 50 mg of DCS at each of 3 cue exposure sessions and placebo at the one-week follow-up session.
1024397|NCT00759473|E5|Reported Event|Placebo/Placebo/Placebo|Participants were assigned to receive placebo at 2 cue exposure sessions, and at the one-week follow-up session.
1024398|NCT00759473|E4|Reported Event|DCS /DCS/Placebo|Participants were assigned to receive 50 mg of DCS at 2 cue exposure sessions, and placebo at the one-week follow-up session.
1024399|NCT00759473|E3|Reported Event|DCS/ Placebo/DCS/Placebo|Participants were assigned to receive 50 mg of DCS at the 1st and 3rd cue sessions and placebo at the 2nd cue session and the one-week follow-up session.
1024400|NCT00759473|E2|Reported Event|Placebo/Placebo/Placebo/Placebo|Participants were assigned to receive a placebo for each of 3 cue exposure sessions and at the one-week follow-up session.
1024401|NCT00759473|E1|Reported Event|DCS/DCS/DCS/Placebo|Participants were assigned to receive 50 mg of DCS for each of 3 cue exposure sessions and a placebo at the one-week follow-up session.
1024402|NCT00759395|B3|Baseline|Total|Total of all reporting groups
1024403|NCT00759395|B2|Baseline|Placebo|Placebo BID, Tablet, Oral, Daily
1024404|NCT00759395|B1|Baseline|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
1024405|NCT00759395|P2|Participant Flow|Placebo|Placebo BID, Tablet, Oral, Daily
1024406|NCT00759395|P1|Participant Flow|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
1024407|NCT00759395|O2|Outcome|Placebo|Placebo BID, Tablet, Oral, Daily
1024408|NCT00759395|O1|Outcome|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
1024409|NCT00759395|O2|Outcome|Placebo|Placebo BID, Tablet, Oral, Daily
1024410|NCT00759395|O1|Outcome|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
1024411|NCT00759395|O2|Outcome|Placebo|Placebo BID, Tablet, Oral, Daily
1024412|NCT00759395|O1|Outcome|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
1024413|NCT00759395|O2|Outcome|Placebo|Placebo BID, Tablet, Oral, Daily
1024414|NCT00759395|O1|Outcome|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
1024415|NCT00759395|O2|Outcome|Placebo|Placebo BID, Tablet, Oral, Daily
1024416|NCT00759395|O1|Outcome|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
1024417|NCT00759395|E2|Reported Event|Placebo|Placebo BID, Tablet, Oral, Daily
1024418|NCT00759395|E1|Reported Event|AZD2327|AZD2327 3mg BID Tablet, Oral, Daily
1024419|NCT00759356|B3|Baseline|Total|Total of all reporting groups
1024420|NCT00759356|B2|Baseline|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
1024421|NCT00759356|B1|Baseline|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
1024422|NCT00759356|P2|Participant Flow|Period 2: Treatment A or B|Treatment B (reference product) followed by Treatment A (test product)
1024423|NCT00759356|P1|Participant Flow|Period 1: Treatment A or B|Treatment A (test product) followed by Treatment B (reference product)
1024424|NCT00759356|O2|Outcome|KADIAN® 200 mg Capsule|
1024425|NCT00759356|O1|Outcome|Morphine Sulfate SR 200 mg Capsule|
1024426|NCT00759356|O2|Outcome|KADIAN® 200 mg Capsule|
1024427|NCT00759356|O1|Outcome|Morphine Sulfate SR 200 mg Capsule|
1024428|NCT00759356|O2|Outcome|KADIAN® 200 mg Capsule|
1024429|NCT00759356|O1|Outcome|Morphine Sulfate SR 200 mg Capsule|
1024430|NCT00759356|O2|Outcome|KADIAN® 200 mg Capsule|
1024431|NCT00759356|O1|Outcome|Morphine Sulfate SR 200 mg Capsule|
1024432|NCT00759356|E2|Reported Event|Arm 2: Treatment B Followed by Treatment A|
1024433|NCT00759356|E1|Reported Event|Arm 1: Treatment A Followed by Treatment B|
1024434|NCT00759330|B5|Baseline|Total|Total of all reporting groups
1024435|NCT00759330|B4|Baseline|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
1024436|NCT00759330|B3|Baseline|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
1024437|NCT00759330|B2|Baseline|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
1024438|NCT00759330|B1|Baseline|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
1024439|NCT00759330|P4|Participant Flow|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape included 31.5 mg flurbiprofen for a total daily dose of 63 mg.
1024440|NCT00759330|P3|Participant Flow|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
1024441|NCT00759330|P2|Participant Flow|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
1024442|NCT00759330|P1|Participant Flow|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
1024443|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
1024444|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
1024445|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
1024446|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
1024447|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
1024448|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
1024449|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
1024450|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
1024451|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
1024452|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
1024453|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
1024454|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
1024455|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape included 31.5 mg flurbiprofen for a total daily dose of 63 mg.
1024456|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
1024457|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
1024458|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
1024459|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
1024460|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
1024461|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
1024462|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
1024463|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
1024464|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
1024465|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
1024466|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
1024467|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
1024468|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
1024469|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
1024470|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
1024471|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
1024472|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
1024473|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
1024474|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
1024475|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
1024476|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
1024477|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
1024478|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
1024479|NCT00759330|O4|Outcome|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
1024480|NCT00759330|O3|Outcome|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
1024481|NCT00759330|O2|Outcome|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
1024482|NCT00759330|O1|Outcome|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
1024483|NCT00759330|E4|Reported Event|Flurbiprofen Tape, Daily for 24 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape included 31.5 mg flurbiprofen for a total daily dose of 63 mg.
1024484|NCT00759330|E3|Reported Event|Placebo Tape, Daily for 24 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day.
1024485|NCT00759330|E2|Reported Event|Flurbiprofen Tape, Daily for 12 Hours|Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape included 31.5 mg flurbiprofen for a total daily dose of 63 mg.
1024486|NCT00759330|E1|Reported Event|Placebo Tape, Daily for 12 Hours|Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day.
1024487|NCT00759187|B4|Baseline|Total|Total of all reporting groups
1024488|NCT00759187|B3|Baseline|Chlorhexidine Gluconate|
1024489|NCT00759187|B2|Baseline|Fluoride/Triclosan|
1024490|NCT00759187|B1|Baseline|Fluoride|
1024491|NCT00759187|P3|Participant Flow|Chlorhexidine Gluconate|
1024492|NCT00759187|P2|Participant Flow|Fluoride/Triclosan|
1024493|NCT00759187|P1|Participant Flow|Fluoride|
1024494|NCT00759187|O3|Outcome|Chlorhexidine Gluconate|
1024495|NCT00759187|O2|Outcome|Fluoride/Triclosan|
1024496|NCT00759187|O1|Outcome|Fluoride|
1024497|NCT00759187|E3|Reported Event|Chlorhexidine Gluconate|
1024498|NCT00759187|E2|Reported Event|Fluoride/Triclosan|
1024499|NCT00759187|E1|Reported Event|Fluoride|
1024500|NCT00759174|B3|Baseline|Total|Total of all reporting groups
1024501|NCT00759174|B2|Baseline|Potential NAION Cases Without PDE5i Exposure|Participants who met pre-defined potential acute NAION criteria and were not exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.
1024502|NCT00759174|B1|Baseline|Potential NAION Cases With PDE5i Exposure|Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.
1024503|NCT00759174|P2|Participant Flow|Potential NAION Cases Without PDE5i Exposure|Participants who met pre-defined potential acute NAION criteria and were not exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.
1024504|NCT00759174|P1|Participant Flow|Potential NAION Cases With PDE5i Exposure|Participants who met pre-defined potential acute nonarteritic anterior ischemic optic neuropathy (NAION) criteria and were exposed to phosphodiesterase type 5 inhibitors (PDE5i) (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.
1024505|NCT00759174|O2|Outcome|Potential NAION Cases With PDE5i Exposure/ Control Window|Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Control windows are the 7 weeks preceding the case window.
1024506|NCT00759174|O1|Outcome|Potential NAION Cases With PDE5i Exposure/ Case Window|Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Case window is the week preceding the symptom onset day.
1024507|NCT00759174|O2|Outcome|Potential NAION Cases With PDE5i Exposure/ Control Window|Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Control windows are the 29 days preceding the case window.
1024508|NCT00759174|O1|Outcome|Potential NAION Cases With PDE5i Exposure/ Case Window|Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Case window is the day preceding the symptom onset day.
1024509|NCT00759174|O2|Outcome|Potential NAION Cases With PDE5i Exposure/ Control Window|Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Control windows are the 29 days preceding the case window.
1024510|NCT00759174|O1|Outcome|Potential NAION Cases With PDE5i Exposure/ Case Window|Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Case window is the day preceding the symptom onset day.
1024511|NCT00759174|E1|Reported Event|Potential NAION Cases|All participants who met pre-defined potential acute NAION criteria and were either exposed or not exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.
1024512|NCT00759161|B1|Baseline|AN2728 5% Ointment + Ointment Vehicle|AN2728 ointment, 5 percent (%) and ointment vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques within each participant respectively, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
1024513|NCT00759161|P1|Participant Flow|AN2728 5% Ointment + Ointment Vehicle|AN2728 ointment, 5 percent (%) and ointment vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques within each participant respectively, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
1024514|NCT00759161|O1|Outcome|AN2728 5% Ointment + Ointment Vehicle|AN2728 ointment, 5 percent (%) and ointment vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques within each participant respectively, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
1024515|NCT00759161|O2|Outcome|Ointment Vehicle|AN2728 ointment vehicle was applied to 1 of the 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
1024516|NCT00759161|O1|Outcome|AN2728 5% Ointment|AN2728 ointment, 5 percent (%) was applied to 1 of the 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
1024517|NCT00759161|O2|Outcome|Ointment Vehicle|AN2728 ointment vehicle was applied to 1 of the 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
1024518|NCT00759161|O1|Outcome|AN2728 5% Ointment|AN2728 ointment, 5 percent (%) was applied to 1 of the 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
1024519|NCT00759161|O2|Outcome|Ointment Vehicle|AN2728 ointment vehicle was applied to 1 of the 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
1024520|NCT00759161|O1|Outcome|AN2728 5% Ointment|AN2728 ointment, 5 percent (%) was applied to 1 of the 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
1024521|NCT00759161|O2|Outcome|AN2728 Ointment Vehicle|AN2728 ointment vehicle was applied to 1 of the 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
1024522|NCT00759161|O1|Outcome|AN2728 5% Ointment|AN2728 ointment, 5 percent (%) was applied to 1 of the 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
1024523|NCT00759161|O1|Outcome|AN2728 5% Ointment + Ointment Vehicle|AN2728 ointment, 5 percent (%) and ointment vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques within each participant respectively, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
1024524|NCT00759161|E1|Reported Event|AN2728 5% Ointment + Ointment Vehicle|AN2728 ointment, 5 percent (%) and ointment vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques within each participant, twice daily for 4 weeks. Plaques were identified at Baseline (Day 1) by investigator.
1024525|NCT00759148|B3|Baseline|Total|Total of all reporting groups
1024526|NCT00759148|B2|Baseline|Moxifloxacin AF Vehicle|Moxifloxacin AF Ophthalmic Solution Vehicle (placebo)
1024527|NCT00759148|B1|Baseline|Moxifloxacin AF|Moxifloxacin AF Ophthalmic Solution
1024528|NCT00759148|P2|Participant Flow|Moxifloxacin AF Vehicle|Moxifloxacin AF Ophthalmic Solution Vehicle (placebo)
1024529|NCT00759148|P1|Participant Flow|Moxifloxacin AF|Moxifloxacin AF Ophthalmic Solution
1024530|NCT00759148|O2|Outcome|Moxifloxacin AF Vehicle|Moxifloxacin AF Ophthalmic Solution Vehicle (placebo)
1024531|NCT00759148|O1|Outcome|Moxifloxacin AF|Moxifloxacin AF Ophthalmic Solution
1024532|NCT00759148|O2|Outcome|Moxifloxacin AF Vehicle|Moxifloxacin AF Ophthalmic Solution Vehicle (placebo)
1024533|NCT00759148|O1|Outcome|Moxifloxacin AF|Moxifloxacin AF Ophthalmic Solution
1024534|NCT00759148|E2|Reported Event|Moxifloxacin AF Vehicle|Moxifloxacin AF Ophthalmic Solution Vehicle (placebo)
1024535|NCT00759148|E1|Reported Event|Moxifloxacin AF|Moxifloxacin AF Ophthalmic Solution
1024536|NCT00759109|B3|Baseline|Total|Total of all reporting groups
1024537|NCT00759109|B2|Baseline|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
1024538|NCT00759109|B1|Baseline|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
1024539|NCT00759109|P2|Participant Flow|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
1024540|NCT00759109|P1|Participant Flow|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
1024541|NCT00759109|O2|Outcome|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
1024542|NCT00759109|O1|Outcome|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
1024543|NCT00759109|O2|Outcome|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
1024544|NCT00759109|O1|Outcome|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
1024545|NCT00759109|O2|Outcome|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
1024546|NCT00759109|O1|Outcome|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
1025141|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
1024548|NCT00759109|O1|Outcome|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
1024549|NCT00759109|O2|Outcome|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
1024550|NCT00759109|O1|Outcome|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
1024551|NCT00759109|O2|Outcome|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
1024552|NCT00759109|O1|Outcome|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
1024553|NCT00759109|E2|Reported Event|Arm B - Control|Participants randomized to Arm B were under observation and received no treatment.
1024554|NCT00759109|E1|Reported Event|Arm A - PegIntron|Participants randomized to Arm A received peginterferon α-2b, 50 μg, weekly, for a period of 3 years.
1024555|NCT00759096|B1|Baseline|AcrySof ReSTOR IOL|Acrysof ReSTOR Intraocular Lens (IOL)
1024556|NCT00759096|P1|Participant Flow|AcrySof ReSTOR IOL|Acrysof ReSTOR Intraocular Lens (IOL)
1024557|NCT00759096|O1|Outcome|AcrySof ReSTOR IOL|Acrysof ReSTOR Intraocular Lens (IOL)
1024558|NCT00759096|E1|Reported Event|AcrySof ReSTOR IOL|Acrysof ReSTOR Intraocular Lens (IOL)
1024559|NCT00759031|B3|Baseline|Total|Total of all reporting groups
1024560|NCT00759031|B2|Baseline|Triclosan + Fluoride 1st, Then Fluoride 2nd|Subjects brushed their teeth once with the Triclosan + Fluoride toothpaste and then received plaque scores at baseline and 24 hours. After completed first intervention and washout, subjects used their second study treatment.
1024561|NCT00759031|B1|Baseline|Fluoride 1st, Then Triclosan +Fluoride 2nd|Subjects brushed their teeth once with Fluoride toothpaste and received plaque scores at baseline and 24 hours. After completed first intervention and washout, subjects used their second study treatment.
1024562|NCT00759031|P2|Participant Flow|Triclosan + Fluoride 1st, Fluoride 2nd|Subjects brushed their teeth once with the Triclosan + Fluoride toothpaste and then received plaque scores at baseline and 24 hours. After completed first intervention and washout, subjects used their second study treatment.
1024563|NCT00759031|P1|Participant Flow|Fluoride 1st, Triclosan +Fluoride 2nd|Subjects brushed their teeth once with Fluoride toothpaste and received plaque scores at baseline and 24 hours. After completed first intervention and washout, subjects used their second study treatment.
1024564|NCT00759031|O2|Outcome|Triclosan + Fluoride|Subjects brushed their teeth once with the Triclosan + Fluoride toothpaste and then received plaque scores at baseline and 24 hours.
1024565|NCT00759031|O1|Outcome|Fluoride|Subjects brushed their teeth once with Fluoride toothpaste and received plaque scores at baseline and 24 hours.
1024566|NCT00759031|E2|Reported Event|Triclosan + Fluoride|Subjects brushed their teeth once with the Triclosan + Fluoride toothpaste and then received plaque scores at baseline and 24 hours.
1024567|NCT00759031|E1|Reported Event|Fluoride|Subjects brushed their teeth once with Fluoride toothpaste and received plaque scores at baseline and 24 hours.
1024568|NCT00758836|B5|Baseline|Total|Total of all reporting groups
1024569|NCT00758836|B4|Baseline|Telcagepant 280 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
1024570|NCT00758836|B3|Baseline|Telcagepant 280 mg +APAP 1000 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
1024571|NCT00758836|B2|Baseline|Telcagepant 280 mg +Ibuprofen 400 mg|Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
1024572|NCT00758836|B1|Baseline|Placebo|Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
1024573|NCT00758836|P4|Participant Flow|Telcagepant 280 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
1024574|NCT00758836|P3|Participant Flow|Telcagepant 280 mg +APAP 1000 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
1024575|NCT00758836|P2|Participant Flow|Telcagepant 280 mg +Ibuprofen 400 mg|Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
1024576|NCT00758836|P1|Participant Flow|Placebo|Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
1024577|NCT00758836|O4|Outcome|Telcagepant 280 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
1024578|NCT00758836|O3|Outcome|Telcagepant 280 mg +APAP 1000 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
1024579|NCT00758836|O2|Outcome|Telcagepant 280 mg +Ibuprofen 400 mg|Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
1024580|NCT00758836|O1|Outcome|Placebo|Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
1024581|NCT00758836|O4|Outcome|Telcagepant 280 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
1024582|NCT00758836|O3|Outcome|Telcagepant 280 mg +APAP 1000 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
1024583|NCT00758836|O2|Outcome|Telcagepant 280 mg +Ibuprofen 400 mg|Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
1024584|NCT00758836|O1|Outcome|Placebo|Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
1024585|NCT00758836|O4|Outcome|Telcagepant 280 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
1024586|NCT00758836|O3|Outcome|Telcagepant 280 mg +APAP 1000 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
1024587|NCT00758836|O2|Outcome|Telcagepant 280 mg +Ibuprofen 400 mg|Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
1024588|NCT00758836|O1|Outcome|Placebo|Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
1024589|NCT00758836|O4|Outcome|Telcagepant 280 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
1024590|NCT00758836|O3|Outcome|Telcagepant 280 mg +APAP 1000 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
1024591|NCT00758836|O2|Outcome|Telcagepant 280 mg +Ibuprofen 400 mg|Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
1024592|NCT00758836|O1|Outcome|Placebo|Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
1024593|NCT00758836|E4|Reported Event|Telcagepant 280 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
1024594|NCT00758836|E3|Reported Event|Telcagepant 280 mg +APAP 1000 mg|Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine
1024595|NCT00758836|E2|Reported Event|Telcagepant 280 mg +Ibuprofen 400 mg|Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine
1024596|NCT00758836|E1|Reported Event|Placebo|Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine
1024597|NCT00758771|B3|Baseline|Total|Total of all reporting groups
1024598|NCT00758771|B2|Baseline|Healthy|Individuals who do not have cystic fibrosis and who do not have any other lung conditions
1024599|NCT00758771|B1|Baseline|Cystic Fibrosis|Individuals who have been diagnosed with cystic fibrosis.
1024600|NCT00758771|P2|Participant Flow|Healthy|Individuals who do not have cystic fibrosis and who do not have any other lung conditions
1024601|NCT00758771|P1|Participant Flow|Cystic Fibrosis|Individuals who have been diagnosed with cystic fibrosis.
1024602|NCT00758771|O2|Outcome|Healthy|Individuals who do not have cystic fibrosis and who do not have any other lung conditions
1024603|NCT00758771|O1|Outcome|Cystic Fibrosis|Individuals who have been diagnosed with cystic fibrosis.
1024604|NCT00758771|E2|Reported Event|Healthy|Individuals who do not have cystic fibrosis and who do not have any other lung conditions
1024605|NCT00758771|E1|Reported Event|Cystic Fibrosis|Individuals who have been diagnosed with cystic fibrosis.
1024606|NCT00758758|B9|Baseline|Total|Total of all reporting groups
1024607|NCT00758758|B8|Baseline|Allograft 2 Levels With Plate|Allograft 2 levels with plate
1024608|NCT00758758|B7|Baseline|Autograft 2 Levels With Plate|Autograft 2 levels with plate
1024609|NCT00758758|B6|Baseline|Allograft With Plate|Allograft with plate
1024610|NCT00758758|B5|Baseline|Autograft With Plate|Autograft with plate
1024611|NCT00758758|B4|Baseline|Autograft Only - Illiac Crest|Autograft only - Illiac crest
1024612|NCT00758758|B3|Baseline|Hedrocel 2 Levels With Plate|Hedrocel 2 levels with plate
1024613|NCT00758758|B2|Baseline|Hedrocel 1 Level With Plate|Hedrocel 1 level with plate
1024614|NCT00758758|B1|Baseline|Hedrocel 1 Level Without Plate|Hedrocel 1 level without plate
1024615|NCT00758758|P8|Participant Flow|Autograft 2 Levels With Plate|Autograft 2 levels with plate
1024616|NCT00758758|P7|Participant Flow|Allograft 2 Levels With Plate|Allograft 2 levels with plate
1024617|NCT00758758|P6|Participant Flow|Allograft 1 Level With Plate|Allograft 1 level plated
1024618|NCT00758758|P5|Participant Flow|Autograft 1 Level With Plate|Autograft 1 level plated
1024619|NCT00758758|P4|Participant Flow|Autograft Only - Illiac Crest|Autograft only - illiac crest
1024620|NCT00758758|P3|Participant Flow|Hedrocel 2 Levels With Plate|Hedrocel 2 levels with plate
1024621|NCT00758758|P2|Participant Flow|Hedrocel 1 Level With Plate|Hedrocel 1 level with plate
1024622|NCT00758758|P1|Participant Flow|Hedrocel 1 Level Without Plate|Hedrocel 1 level without plate
1024623|NCT00758758|O8|Outcome|Allograft With 2 Plates|2 Levels with plated Allograft
1024624|NCT00758758|O7|Outcome|Autograft With 2 Plates|2 Levels with plated Autograft
1024625|NCT00758758|O6|Outcome|Allograft With Plate|Plated Allograft
1024626|NCT00758758|O5|Outcome|Autograft With Plate|Plated Autograft
1024627|NCT00758758|O4|Outcome|Illiac Crest Autograft|Iliac Crest Autograft
1024628|NCT00758758|O3|Outcome|2 Levels Hedrocel With Plate|2 Levels Plated Hedrocel
1024629|NCT00758758|O2|Outcome|Hedrocel With Plate|Hedrocel with a plate
1024630|NCT00758758|O1|Outcome|1 Level Hedrocel Without Plate|1 level Hedrocel without plate
1024631|NCT00758758|O8|Outcome|2 Levels With Plated Allograft|2 Levels with plated Allograft
1024632|NCT00758758|O7|Outcome|2 Levels Plated Autograft|2 Levels with plated Autograft
1024633|NCT00758758|O6|Outcome|Plated Allograft|Plated Allograft
1024634|NCT00758758|O5|Outcome|Plated Autograft|Plated Autograft
1024635|NCT00758758|O4|Outcome|Illiac Crest Autograft - no Plate|Iliac Crest Autograft
1024636|NCT00758758|O3|Outcome|Two Levels Plated Hedrocel|2 Levels Plated Hedrocel
1024637|NCT00758758|O2|Outcome|One Level Hedrocel With Plate|Hedrocel with a plate
1024638|NCT00758758|O1|Outcome|1 Level Hedrocel Without Plate|1 level Hedrocel with out plate
1024639|NCT00758758|E8|Reported Event|Allograft 2 Levels With Plate|Allograft 2 levels with plate
1024640|NCT00758758|E7|Reported Event|Autograft 2 Levels With Plate|Autograft 2 levels with plate
1024641|NCT00758758|E6|Reported Event|Allograft With Plate|Allograft with plate
1024642|NCT00758758|E5|Reported Event|Autograft With Plate|Autograft with plate
1024643|NCT00758758|E4|Reported Event|Autograft Only - Illiac Crest|Autograft only - Illiac crest
1024644|NCT00758758|E3|Reported Event|Hedrocel 2 Levels With Plate|Hedrocel 2 levels with plate
1024645|NCT00758758|E2|Reported Event|Hedrocel 1 Level With Plate|Hedrocel 1 level with plate
1024646|NCT00758758|E1|Reported Event|Hedrocel 1 Level Without Plate|Hedrocel 1 level without plate
1024647|NCT00758745|B3|Baseline|Total|Total of all reporting groups
1024648|NCT00758745|B2|Baseline|Model MA60AC|Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)
1024649|NCT00758745|B1|Baseline|Model SN60WF|Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL)
1024650|NCT00758745|P2|Participant Flow|Model MA60AC|Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)
1024651|NCT00758745|P1|Participant Flow|Model SN60WF|Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL)
1024652|NCT00758745|O2|Outcome|Model MA60AC|Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)
1024653|NCT00758745|O1|Outcome|Model SN60WF|Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL)
1024654|NCT00758745|E2|Reported Event|Model MA60AC|Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL)
1024655|NCT00758745|E1|Reported Event|Model SN60WF|Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL)
1024656|NCT00758706|B3|Baseline|Total|Total of all reporting groups
1024657|NCT00758706|B2|Baseline|Placebo|Placebo to AZD1236 twice daily(bid)
1024658|NCT00758706|B1|Baseline|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
1024659|NCT00758706|P2|Participant Flow|Placebo|Placebo to AZD1236 twice daily(bid)
1024660|NCT00758706|P1|Participant Flow|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
1024661|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
1024662|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
1024663|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
1024664|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
1024665|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
1024666|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
1024667|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
1024668|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
1024669|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
1024670|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
1024671|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
1024672|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
1024673|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
1024674|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
1024675|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
1024676|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
1024677|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
1024678|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
1024679|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
1024680|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
1024681|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
1024682|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
1024683|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
1024684|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
1024685|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
1024686|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
1024687|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
1024688|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
1024689|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
1024690|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
1024691|NCT00758706|O2|Outcome|Placebo|Placebo to AZD1236 twice daily(bid)
1024692|NCT00758706|O1|Outcome|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
1024693|NCT00758706|E2|Reported Event|Placebo|Placebo to AZD1236 twice daily(bid)
1024694|NCT00758706|E1|Reported Event|AZD1236|AZD1236 75mg oral tablet twice daily(bid)
1024695|NCT00758680|B1|Baseline|All Treated Participants|After a 2-week run-in/wash-off period, participants received doses of MK-1006 or matching placebo over a multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
1024696|NCT00758680|P10|Participant Flow|Placebo|After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
1024697|NCT00758680|P9|Participant Flow|MK-1006 50 mg Twice Daily Outpatient (Panel I)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
1024698|NCT00758680|P8|Participant Flow|MK-1006 120 mg Once Daily Outpatient (Panel H)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
1024699|NCT00758680|P7|Participant Flow|MK-1006 50 mg Twice Daily (Panel G)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
1024700|NCT00758680|P6|Participant Flow|MK-1006 30 mg Twice Daily (Panel F)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
1024701|NCT00758680|P5|Participant Flow|MK-1006 20 mg Twice Daily (Panel E)|After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
1024702|NCT00758680|P4|Participant Flow|MK-1006 120 mg Once Daily (Panel D)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
1024703|NCT00758680|P3|Participant Flow|MK-1006 80 mg Once Daily (Panel C)|After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
1024704|NCT00758680|P2|Participant Flow|MK-1006 40 mg Once Daily (Panel B)|After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
1024705|NCT00758680|P1|Participant Flow|MK-1006 20 mg Once Daily (Panel A)|After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
1024706|NCT00758680|O10|Outcome|Placebo|After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
1024707|NCT00758680|O9|Outcome|MK-1006 50 mg Twice Daily Outpatient (Panel I)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
1024708|NCT00758680|O8|Outcome|MK-1006 120 mg Once Daily Outpatient (Panel H)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
1024709|NCT00758680|O7|Outcome|MK-1006 50 mg Twice Daily (Panel G)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
1024710|NCT00758680|O6|Outcome|MK-1006 30 mg Twice Daily (Panel F)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
1024711|NCT00758680|O5|Outcome|MK-1006 20 mg Twice Daily (Panel E)|After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
1024712|NCT00758680|O4|Outcome|MK-1006 120 mg Once Daily (Panel D)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
1024713|NCT00758680|O3|Outcome|MK-1006 80 mg Once Daily (Panel C)|After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
1024714|NCT00758680|O2|Outcome|MK-1006 40 mg Once Daily (Panel B)|After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
1024715|NCT00758680|O1|Outcome|MK-1006 20 mg Once Daily (Panel A)|After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
1024716|NCT00758680|O8|Outcome|Placebo|After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
1024717|NCT00758680|O7|Outcome|MK-1006 50 mg Twice Daily (Panel G)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
1024718|NCT00758680|O6|Outcome|MK-1006 30 mg Twice Daily (Panel F)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
1024719|NCT00758680|O5|Outcome|MK-1006 20 mg Twice Daily (Panel E)|After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
1024720|NCT00758680|O4|Outcome|MK-1006 120 mg Once Daily (Panel D)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
1024721|NCT00758680|O3|Outcome|MK-1006 80 mg Once Daily (Panel C)|After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
1024722|NCT00758680|O2|Outcome|MK-1006 40 mg Once Daily (Panel B)|After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
1024723|NCT00758680|O1|Outcome|MK-1006 20 mg Once Daily (Panel A)|After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
1024724|NCT00758680|O10|Outcome|Placebo|After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
1024725|NCT00758680|O9|Outcome|MK-1006 50 mg Twice Daily Outpatient (Panel I)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
1024726|NCT00758680|O8|Outcome|MK-1006 120 mg Once Daily Outpatient (Panel H)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
1024727|NCT00758680|O7|Outcome|MK-1006 50 mg Twice Daily (Panel G)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
1024728|NCT00758680|O6|Outcome|MK-1006 30 mg Twice Daily (Panel F)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
1024729|NCT00758680|O5|Outcome|MK-1006 20 mg Twice Daily (Panel E)|After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
1024730|NCT00758680|O4|Outcome|MK-1006 120 mg Once Daily (Panel D)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
1024731|NCT00758680|O3|Outcome|MK-1006 80 mg Once Daily (Panel C)|After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
1024732|NCT00758680|O2|Outcome|MK-1006 40 mg Once Daily (Panel B)|After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
1024733|NCT00758680|O1|Outcome|MK-1006 20 mg Once Daily (Panel A)|After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
1025142|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1024734|NCT00758680|E10|Reported Event|Placebo|After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
1024735|NCT00758680|E9|Reported Event|MK-1006 50 mg Twice Daily Outpatient (Panel I)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
1024736|NCT00758680|E8|Reported Event|MK-1006 120 mg Once Daily Outpatient (Panel H)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
1024737|NCT00758680|E7|Reported Event|MK-1006 50 mg Twice Daily (Panel G)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
1024738|NCT00758680|E6|Reported Event|MK-1006 30 mg Twice Daily (Panel F)|After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
1024739|NCT00758680|E5|Reported Event|MK-1006 20 mg Twice Daily (Panel E)|After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
1024740|NCT00758680|E4|Reported Event|MK-1006 120 mg Once Daily (Panel D)|After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
1024741|NCT00758680|E3|Reported Event|MK-1006 80 mg Once Daily (Panel C)|After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
1024742|NCT00758680|E2|Reported Event|MK-1006 40 mg Once Daily (Panel B)|After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
1024743|NCT00758680|E1|Reported Event|MK-1006 20 mg Once Daily (Panel A)|After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
1024744|NCT00758667|B3|Baseline|Total|Total of all reporting groups
1024745|NCT00758667|B2|Baseline|Mesna|"The use of Mesna of removal of capsule for capsular contracture.~Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
1024746|NCT00758667|B1|Baseline|Standard|"Standard procedure or capsulectomy for removal of capsule; no mesna~Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
1024747|NCT00758667|P2|Participant Flow|Mesna|"The use of Mesna of removal of capsule for capsular contracture.~Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
1024748|NCT00758667|P1|Participant Flow|Standard|Standard procedure or capsulectomy for removal of capsule;
1024749|NCT00758667|O2|Outcome|Mesna|"The use of Mesna of removal of capsule for capsular contracture.~Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
1024750|NCT00758667|O1|Outcome|Standard|Standard procedure or capsulectomy for removal of capsule;
1024751|NCT00758667|O2|Outcome|Mesna|"The use of Mesna of removal of capsule for capsular contracture.~Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
1024752|NCT00758667|O1|Outcome|Standard|"Standard procedure or capsulectomy for removal of capsule; no mesna~Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
1024753|NCT00758667|E2|Reported Event|Mesna|"The use of Mesna of removal of capsule for capsular contracture.~Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed"
1024754|NCT00758667|E1|Reported Event|Standard|Standard procedure or capsulectomy for removal of capsule;
1024755|NCT00758602|B3|Baseline|Total|Total of all reporting groups
1024756|NCT00758602|B2|Baseline|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
1024757|NCT00758602|B1|Baseline|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
1024758|NCT00758602|P2|Participant Flow|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
1024759|NCT00758602|P1|Participant Flow|Mycophenolate Mofetil (MMF), Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 gram (g) orally (PO), twice daily (BID) from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 nanograms per milliliter (ng/mL) from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
1024811|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
1024812|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
1024813|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
1024760|NCT00758602|O2|Outcome|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
1024761|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
1024762|NCT00758602|O2|Outcome|MMFl, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
1024763|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
1024764|NCT00758602|O2|Outcome|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
1024765|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
1024766|NCT00758602|O2|Outcome|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
1024767|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
1024768|NCT00758602|O2|Outcome|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
1024769|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
1024770|NCT00758602|O2|Outcome|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
1024771|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
1024772|NCT00758602|O2|Outcome|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
1024814|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
1024815|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
1024773|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
1024774|NCT00758602|O2|Outcome|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
1024775|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
1024776|NCT00758602|O2|Outcome|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
1024777|NCT00758602|O1|Outcome|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
1024778|NCT00758602|E2|Reported Event|MMF, Low Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
1024779|NCT00758602|E1|Reported Event|MMF, Standard Dose Tacrolimus|Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.
1024780|NCT00758589|B5|Baseline|Total|Total of all reporting groups
1024781|NCT00758589|B4|Baseline|Placebo|placebo oral tablet, twice daily
1024782|NCT00758589|B3|Baseline|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
1024783|NCT00758589|B2|Baseline|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
1024784|NCT00758589|B1|Baseline|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
1024785|NCT00758589|P4|Participant Flow|Placebo|placebo oral tablet, twice daily
1024786|NCT00758589|P3|Participant Flow|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
1024787|NCT00758589|P2|Participant Flow|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
1024788|NCT00758589|P1|Participant Flow|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
1024789|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
1024790|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
1024791|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
1024792|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
1024793|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
1024794|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
1024795|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
1024796|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
1024797|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
1024798|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
1024799|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
1024800|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
1024801|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
1024802|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
1024803|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
1024804|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
1024805|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
1024806|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
1024807|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
1024808|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
1024809|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
1024810|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
1024982|NCT00758459|P1|Participant Flow|AZD1236|AZD1236
1024816|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
1024817|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
1024818|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
1024819|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
1024820|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
1024821|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
1024822|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
1024823|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
1024824|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
1024825|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
1024826|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
1024827|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
1024828|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
1024829|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
1024830|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
1024831|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
1024832|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
1024833|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
1024834|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
1024835|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
1024836|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
1024837|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
1024838|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
1024839|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
1024840|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
1024841|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
1024842|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
1024843|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
1024844|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
1024845|NCT00758589|O4|Outcome|Placebo|placebo oral tablet, twice daily
1024846|NCT00758589|O3|Outcome|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
1024847|NCT00758589|O2|Outcome|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
1024848|NCT00758589|O1|Outcome|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
1024849|NCT00758589|E4|Reported Event|Placebo|placebo oral tablet, twice daily
1024850|NCT00758589|E3|Reported Event|AZD1981 1000 mg Twice Daily (Bid)|AZD1981 oral tablet 1000 mg, twice daily
1024851|NCT00758589|E2|Reported Event|AZD1981 400 mg Twice Daily (Bid)|AZD1981 oral tablet 400 mg, twice daily
1024852|NCT00758589|E1|Reported Event|AZD1981 50 mg Twice Daily (Bid)|AZD1981 oral tablet 50 mg, twice daily
1024853|NCT00758576|B1|Baseline|SN6AD1|ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
1024854|NCT00758576|P1|Participant Flow|SN6AD1|ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
1024855|NCT00758576|O1|Outcome|SN6AD1|ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
1024856|NCT00758576|O1|Outcome|SN6AD1|ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
1024857|NCT00758576|O1|Outcome|SN6AD1|ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
1024858|NCT00758576|E1|Reported Event|SN6AD1|ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
1024859|NCT00758563|B3|Baseline|Total|Total of all reporting groups
1024860|NCT00758563|B2|Baseline|Triclosan|
1024861|NCT00758563|B1|Baseline|Fluoride|
1024862|NCT00758563|P2|Participant Flow|Triclosan|
1024863|NCT00758563|P1|Participant Flow|Fluoride|
1024864|NCT00758563|O2|Outcome|Triclosan|
1024865|NCT00758563|O1|Outcome|Fluoride|
1024866|NCT00758550|B3|Baseline|Total|Total of all reporting groups
1024867|NCT00758550|B2|Baseline|AcrySof Natural IOL|AcrySof Natural Intraocular Lens
1024868|NCT00758550|B1|Baseline|AcrySof Toric IOL|AcrySof Toric Intraocular Lens
1024869|NCT00758550|P2|Participant Flow|AcrySof Natural IOL|AcrySof Natural Intraocular Lens
1024870|NCT00758550|P1|Participant Flow|AcrySof Toric IOL|AcrySof Toric Intraocular Lens
1024871|NCT00758550|O2|Outcome|AcrySof Natural IOL|AcrySof Natural Intraocular Lens
1024872|NCT00758550|O1|Outcome|AcrySof Toric IOL|AcrySof Toric Intraocular Lens
1024873|NCT00758550|O2|Outcome|AcrySof Natural IOL|AcrySof Natural Intraocular Lens
1024874|NCT00758550|O1|Outcome|AcrySof Toric IOL|AcrySof Toric Intraocular Lens
1024875|NCT00758550|E2|Reported Event|AcrySof Natural IOL|AcrySof Natural Intraocular Lens
1024876|NCT00758550|E1|Reported Event|AcrySof Toric IOL|AcrySof Toric Intraocular Lens
1024877|NCT00758498|B4|Baseline|Total|Total of all reporting groups
1024878|NCT00758498|B3|Baseline|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024879|NCT00758498|B2|Baseline|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024983|NCT00758459|O2|Outcome|Placebo|Placebo
1024984|NCT00758459|O1|Outcome|AZD1236|AZD1236
1024985|NCT00758459|O2|Outcome|Placebo|Placebo
1024880|NCT00758498|B1|Baseline|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024881|NCT00758498|P3|Participant Flow|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024882|NCT00758498|P2|Participant Flow|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024883|NCT00758498|P1|Participant Flow|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024884|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024885|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024886|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024887|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024888|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024889|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024890|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024891|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024892|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024893|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024894|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024895|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024896|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024897|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024898|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024899|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024900|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024901|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024902|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024903|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024904|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024905|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024906|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024907|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024908|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024909|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024910|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024911|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024912|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024913|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024914|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024915|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024916|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024917|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024918|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024919|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024920|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024921|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024922|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024923|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024924|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024925|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024926|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024927|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024928|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024929|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024930|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024931|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024932|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024933|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024934|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024935|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024936|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024937|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024938|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024939|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024940|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024941|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024942|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024943|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024944|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024945|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024946|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024947|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024948|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024949|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024950|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024951|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024952|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024953|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024954|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024955|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024956|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024957|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024958|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024959|NCT00758498|O3|Outcome|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024960|NCT00758498|O2|Outcome|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024961|NCT00758498|O1|Outcome|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024962|NCT00758498|E3|Reported Event|Placebo|Subjects were randomly assigned to one of three treatment groups 1:1:1. Placebo was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024963|NCT00758498|E2|Reported Event|Armodafinil 150 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 150 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024964|NCT00758498|E1|Reported Event|Armodafinil 50 mg/Day|Subjects were randomly assigned to one of three treatment groups 1:1:1. Armodafinil 50 mg was administered orally once daily at approximately 0800 (8:00am) on days 1, 2, and 3.
1024965|NCT00758485|B3|Baseline|Total|Total of all reporting groups
1024966|NCT00758485|B2|Baseline|Placebo|Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium.
1024967|NCT00758485|B1|Baseline|Sugammadex|Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of NMB of 1-2 PTC after the last dose of rocuronium.
1024968|NCT00758485|P2|Participant Flow|Placebo|Participants receiving Placebo (0.9% sodium chloride[NaCl]) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
1024969|NCT00758485|P1|Participant Flow|Sugammadex|Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of neuromuscular blockade (NMB) of 1-2 Post Tetanic Count (PTC) after the last dose of rocuronium
1024970|NCT00758485|O2|Outcome|Placebo|Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
1024971|NCT00758485|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
1024972|NCT00758485|O2|Outcome|Placebo|Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
1024973|NCT00758485|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
1024974|NCT00758485|O2|Outcome|Placebo|Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
1024975|NCT00758485|O1|Outcome|Sugammadex|Participants receiving 4.0 mg/kg-1 Sugammadex at a target depth of NMB of 1-2 Post Tetanic Count (PTC) after the last dose of rocuronium
1024976|NCT00758485|E2|Reported Event|Placebo|Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
1024977|NCT00758485|E1|Reported Event|Sugammadex|Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of NMB of 1-2 PTC after the last dose of rocuronium
1024978|NCT00758459|B3|Baseline|Total|Total of all reporting groups
1024979|NCT00758459|B2|Baseline|Placebo|Placebo
1024980|NCT00758459|B1|Baseline|AZD1236|AZD1236
1024981|NCT00758459|P2|Participant Flow|Placebo|Placebo
1025014|NCT00758420|B2|Baseline|Polidocanol Injectable Foam, 1.0%|Polidocanol injectable foam 1%, up to 15 mL, one treatment session
1025015|NCT00758420|B1|Baseline|Placebo|Agitated Saline: 10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session
1025016|NCT00758420|P2|Participant Flow|Placebo|"Agitated saline~Agitated Saline: 10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session"
1025017|NCT00758420|P1|Participant Flow|Active Treatment|polidocanol injectiable foam 1%, up to 15 mL, one treatment session
1025018|NCT00758420|O2|Outcome|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam 1%, up to 15 mL, one treatment session
1025019|NCT00758420|O1|Outcome|Placebo|agitated saline
1025020|NCT00758420|E2|Reported Event|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam 1%, up to 15 mL, one treatment session
1025021|NCT00758420|E1|Reported Event|Placebo|agitated saline
1025022|NCT00758394|B5|Baseline|Total|Total of all reporting groups
1025023|NCT00758394|B4|Baseline|Triclosan/Fluoride/Cavistat|toothpaste containing bicarbonate
1025024|NCT00758394|B3|Baseline|Triclosan/Fluoride/Arginine|toothpaste containing amino acid
1025025|NCT00758394|B2|Baseline|Fluoride/Triclosan - B|Positive control comparator
1025026|NCT00758394|B1|Baseline|Fluoride - A|Negative control
1025027|NCT00758394|P4|Participant Flow|Triclosan/Fluoride/Cavistat First|Triclosan/fluoride/Cavistat first, fluoride second,Triclosan/fluoride third, Triclosan/fluoride/Arginine last
1025028|NCT00758394|P3|Participant Flow|Triclosan/Fluoride/Arginine First|Triclosan/fluoride/Arginine first, Triclosan/fluoride/Cavistat second,fluoride third, triclosan/fluoride last
1025029|NCT00758394|P2|Participant Flow|Triclosan/Fluoride First|Triclosan fluoride first, Triclosan/fluoride/Arginine second, Triclosan/fluoride/Cavistat third, fluoride last
1025030|NCT00758394|P1|Participant Flow|Fluoride First|Fluoride first, triclosan/fluoride second,Arginine/fluoride third and Cavistat/fluoride last
1025031|NCT00758394|O4|Outcome|Triclosan/Fluoride/Cavistat|toothpaste containing bicarbonate
1025032|NCT00758394|O3|Outcome|Triclosan/Fluoride/Arginine|toothpaste containing amino acid
1025033|NCT00758394|O2|Outcome|Fluoride/Triclosan - B|Positive control comparator
1025034|NCT00758394|O1|Outcome|Fluoride - A|Negative control
1025035|NCT00758394|E4|Reported Event|Triclosan/Fluoride/Cavistat First|Triclosan/fluoride/Cavistat first, fluoride second,Triclosan/fluoride third, Triclosan/fluoride/Arginine last
1025036|NCT00758394|E3|Reported Event|Triclosan/Fluoride/Arginine First|Triclosan/fluoride/Arginine first, Triclosan/fluoride/Cavistat second,fluoride third, triclosan/fluoride last
1025037|NCT00758394|E2|Reported Event|Triclosan/Fluoride First|Triclosan fluoride first, Triclosan/fluoride/Arginine second, Triclosan/fluoride/Cavistat third, fluoride last
1025038|NCT00758394|E1|Reported Event|Fluoride First|Fluoride first, triclosan/fluoride second,Arginine/fluoride third and Cavistat/fluoride last
1025039|NCT00758342|B3|Baseline|Total|Total of all reporting groups
1025040|NCT00758342|B2|Baseline|Travoprost 0.004% + Tears Natural|Travoprost 0.004% + Tears Natural
1025041|NCT00758342|B1|Baseline|Travoprost 0.004% + Brinzolamide 1.0%|Travoprost 0.004% + Brinzolamide 1.0%
1025042|NCT00758342|P2|Participant Flow|Travoprost 0.004% + Tears Natural|Travoprost 0.004% + Tears Natural
1025043|NCT00758342|P1|Participant Flow|Travoprost 0.004% + Brinzolamide 1.0%|Travoprost 0.004% + Brinzolamide 1.0%
1025044|NCT00758342|O2|Outcome|Travoprost 0.004% + Tears Natural|Travoprost 0.004% + Tears Natural
1025045|NCT00758342|O1|Outcome|Travoprost 0.004% + Brinzolamide 1.0%|Travoprost 0.004% + Brinzolamide 1.0%
1025046|NCT00758342|E2|Reported Event|Travoprost 0.004% + Tears Natural|Travoprost 0.004% + Tears Natural
1025047|NCT00758342|E1|Reported Event|Travoprost 0.004% + Brinzolamide 1.0%|Travoprost 0.004% + Brinzolamide 1.0%
1025048|NCT00758290|B3|Baseline|Total|Total of all reporting groups
1025049|NCT00758290|B2|Baseline|Triclosan/Fluoride|
1025050|NCT00758290|B1|Baseline|Fluoride/Triclosan|
1025051|NCT00758290|P2|Participant Flow|Triclosan/Fluoride|
1025052|NCT00758290|P1|Participant Flow|Fluoride/Triclosan|
1025053|NCT00758290|O2|Outcome|Triclosan/Fluoride|
1025054|NCT00758290|O1|Outcome|Fluoride/Triclosan|
1025055|NCT00758160|B1|Baseline|OROS MPH|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
1025056|NCT00758160|P1|Participant Flow|OROS MPH|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
1025057|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
1025058|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
1025059|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
1025060|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
1025061|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
1025062|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
1025063|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
1025064|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
1025143|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
1025065|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
1025066|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
1025067|NCT00758160|O1|Outcome|OROS MPH|Participants received OROS MPH 18 mg, 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
1025068|NCT00758160|O1|Outcome|OROS MPH|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
1025069|NCT00758160|E4|Reported Event|OROS MPH-Week 8|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
1025070|NCT00758160|E3|Reported Event|OROS MPH-Week 4|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
1025071|NCT00758160|E2|Reported Event|OROS MPH-Week 2|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
1025072|NCT00758160|E1|Reported Event|OROS MPH-Baseline|Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects.
1025073|NCT00758069|B4|Baseline|Total|Total of all reporting groups
1025074|NCT00758069|B3|Baseline|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.
1025075|NCT00758069|B2|Baseline|Sitagliptin 50 mg BID|The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).
1025076|NCT00758069|B1|Baseline|Sitagliptin 100 mg QD|The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
1025077|NCT00758069|P3|Participant Flow|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.
1025078|NCT00758069|P2|Participant Flow|Sitagliptin 50 mg BID|The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).
1025079|NCT00758069|P1|Participant Flow|Sitagliptin 100 mg QD|The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
1025080|NCT00758069|O3|Outcome|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.
1025081|NCT00758069|O2|Outcome|Sitagliptin 50 mg BID|The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).
1025082|NCT00758069|O1|Outcome|Sitagliptin 100 mg QD|The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
1025083|NCT00758069|O3|Outcome|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.
1025084|NCT00758069|O2|Outcome|Sitagliptin 50 mg BID|The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).
1025085|NCT00758069|O1|Outcome|Sitagliptin 100 mg QD|The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
1025086|NCT00758069|E3|Reported Event|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally.
1025087|NCT00758069|E2|Reported Event|Sitagliptin 50 mg BID|The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily).
1025088|NCT00758069|E1|Reported Event|Sitagliptin 100 mg QD|The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
1025089|NCT00758043|B5|Baseline|Total|Total of all reporting groups
1025090|NCT00758043|B4|Baseline|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
1025091|NCT00758043|B3|Baseline|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
1025092|NCT00758043|B2|Baseline|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
1025093|NCT00758043|B1|Baseline|T12PR24 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
1025094|NCT00758043|P4|Participant Flow|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
1025095|NCT00758043|P3|Participant Flow|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
1025096|NCT00758043|P2|Participant Flow|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
1025097|NCT00758043|P1|Participant Flow|T12PR24 (eRVR+)|Telaprevir + peginterferon-alfa-2a (Peg-IFN-alfa-2a) + ribavirin (RBV) for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
1025144|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1025098|NCT00758043|O4|Outcome|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20, were not randomized or assigned to a treatment regimen
1025099|NCT00758043|O3|Outcome|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response and were assigned to this group (not randomized)
1025100|NCT00758043|O2|Outcome|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
1025101|NCT00758043|O1|Outcome|T12PR24 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
1025102|NCT00758043|O4|Outcome|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
1025103|NCT00758043|O3|Outcome|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
1025104|NCT00758043|O2|Outcome|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
1025105|NCT00758043|O1|Outcome|T12PR24 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
1025106|NCT00758043|O4|Outcome|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20, were not randomized or assigned to a treatment regimen
1025107|NCT00758043|O3|Outcome|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response and were assigned to this group (not randomized)
1025108|NCT00758043|O2|Outcome|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
1025109|NCT00758043|O1|Outcome|T12PR24 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
1025110|NCT00758043|O4|Outcome|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20, were not randomized or assigned to a treatment regimen
1025111|NCT00758043|O3|Outcome|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response and were assigned to this group (not randomized)
1025112|NCT00758043|O2|Outcome|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
1025113|NCT00758043|O1|Outcome|T12PR24 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response and were randomized to this group
1025114|NCT00758043|O4|Outcome|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
1025115|NCT00758043|O3|Outcome|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
1025116|NCT00758043|O2|Outcome|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
1025117|NCT00758043|O1|Outcome|T12PR24 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
1025118|NCT00758043|E4|Reported Event|Other|Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
1025119|NCT00758043|E3|Reported Event|T12PR48 (eRVR-)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
1025120|NCT00758043|E2|Reported Event|T12PR48 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
1025121|NCT00758043|E1|Reported Event|T12PR24 (eRVR+)|Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
1025122|NCT00757848|B3|Baseline|Total|Total of all reporting groups
1025123|NCT00757848|B2|Baseline|Placebo|Placebo, 2 tablets twice daily (bid)
1025124|NCT00757848|B1|Baseline|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1025125|NCT00757848|P2|Participant Flow|Placebo|Placebo, 2 tablets twice daily (bid)
1025126|NCT00757848|P1|Participant Flow|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1025127|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
1025128|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1025129|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
1025130|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1025131|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
1025132|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1025133|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
1025134|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1025135|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
1025136|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1025137|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
1025138|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1025139|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
1025167|NCT00757848|E2|Reported Event|Placebo|Placebo, 2 tablets twice daily (bid)
1025168|NCT00757848|E1|Reported Event|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
1025169|NCT00757822|B3|Baseline|Total|Total of all reporting groups
1025170|NCT00757822|B2|Baseline|Arm 2: Ondansetron|"ondansetron~Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
1025171|NCT00757822|B1|Baseline|Arm 1: Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
1025172|NCT00757822|P2|Participant Flow|Arm 2: Ondansetron|"ondansetron~Ondansetron: Ondansetron (4 mg) will be administered iv 20-30 min prior to end of surgery in those patients not receiving Dronabinol."
1025173|NCT00757822|P1|Participant Flow|Arm 1: Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 30-60 min prior start of surgery."
1025174|NCT00757822|O2|Outcome|Arm 2:Ondansetron|"ondansetron~Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
1025175|NCT00757822|O1|Outcome|Arm 1:Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
1025176|NCT00757822|O2|Outcome|Arm 2:Ondansetron|"ondansetron~Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
1025177|NCT00757822|O1|Outcome|Arm 1:Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
1025178|NCT00757822|O2|Outcome|Arm 2: Ondansetron|"ondansetron~Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
1025179|NCT00757822|O1|Outcome|Arm 1:Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
1025180|NCT00757822|O2|Outcome|Arm 2: Ondnasetron|"ondansetron~Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
1025181|NCT00757822|O1|Outcome|Arm 1:Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
1025182|NCT00757822|O2|Outcome|Arm 2:Ondansetron|"ondansetron~Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
1025183|NCT00757822|O1|Outcome|Arm 1:Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
1025184|NCT00757822|O2|Outcome|Arm 2:Ondansetron|"ondansetron~Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
1025185|NCT00757822|O1|Outcome|Arm 1: Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
1025186|NCT00757822|O2|Outcome|Arm 2:Ondansetron|"ondansetron~Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
1025187|NCT00757822|O1|Outcome|Arm 1: Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
1025188|NCT00757822|O2|Outcome|Arm 2:Ondansetron|"ondansetron~Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol."
1025189|NCT00757822|O1|Outcome|Arm 1:Dronabinol|"dronabinol~Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively."
1025190|NCT00757822|E2|Reported Event|Ondansetron-control Therapy|Ondansetron (4 mg) was administered iv 20-30 min prior to end of elective abdominal surgery scheduled for same day discharge to home.
1025191|NCT00757822|E1|Reported Event|Dronabinol- Experimental Therapy|Dronabinol (5mg) was administered po 30-60 min prior to start of elective abdominal surgery scheduled for same day discharge to home.
1025192|NCT00757783|B3|Baseline|Total|Total of all reporting groups
1025193|NCT00757783|B2|Baseline|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
1025194|NCT00757783|B1|Baseline|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
1025195|NCT00757783|P2|Participant Flow|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
1025196|NCT00757783|P1|Participant Flow|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
1025273|NCT00757601|B1|Baseline|All Participants|Participants were treated with MK1006 or dose-matched placebo over 5 treatment periods.
1025197|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
1025198|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
1025199|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
1025200|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
1025201|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
1025202|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
1025203|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
1025204|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
1025316|NCT00757601|O10|Outcome|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
1025205|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
1025206|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
1025207|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
1025208|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
1025209|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
1025210|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
1025211|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
1025212|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
1025213|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
1025214|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
1025215|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
1025216|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
1025217|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
1025218|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
1025219|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
1025220|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
1025221|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
1025222|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
1025223|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
1025224|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
1025225|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
1025226|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
1025227|NCT00757783|O2|Outcome|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
1025306|NCT00757601|O7|Outcome|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
1025228|NCT00757783|O1|Outcome|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
1025229|NCT00757783|E2|Reported Event|Atazanavir|atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
1025230|NCT00757783|E1|Reported Event|Darunavir|Darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks.
1025231|NCT00757705|B1|Baseline|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
1025232|NCT00757705|P1|Participant Flow|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
1025233|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
1025317|NCT00757601|O9|Outcome|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
1025234|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
1025235|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
1025236|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
1025237|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
1025238|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
1025239|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
1025240|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
1025241|NCT00757705|O1|Outcome|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
1025242|NCT00757705|E1|Reported Event|Paliperidone Extended Release (ER)|Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator’s discretion based upon participant’s clinical response to and tolerability of the study drug.
1025243|NCT00757666|B3|Baseline|Total|Total of all reporting groups
1025244|NCT00757666|B2|Baseline|Minute Ventilation|Minute ventilation
1025245|NCT00757666|B1|Baseline|Accelerometer|Accelerometer
1025246|NCT00757666|P2|Participant Flow|Minute Ventilation|Minute ventilation
1025247|NCT00757666|P1|Participant Flow|Accelerometer|Accelerometer
1025248|NCT00757666|O2|Outcome|Minute Ventilation|Minute ventilation
1025249|NCT00757666|O1|Outcome|Accelerometer|Accelerometer
1025250|NCT00757666|O2|Outcome|Minute Ventilation|Minute ventilation
1025251|NCT00757666|O1|Outcome|Accelerometer|Accelerometer
1025252|NCT00757666|O2|Outcome|Minute Ventilation|Minute ventilation
1025253|NCT00757666|O1|Outcome|Accelerometer|Accelerometer
1025254|NCT00757666|O2|Outcome|Minute Ventilation|"Patients implanted with a Boston Scientific ALTRUA 60 pacemaker with minute ventilation sensor.~Rate adaptive pacemaker: Minute ventilation sensor"
1025255|NCT00757666|O1|Outcome|Accelerometer|"Patients implanted with a Boston Scientific ALTRUA 60 pacemaker with accelerometer (motion-based) sensor.~Rate adaptive pacemaker: Accelerometer sensor"
1025256|NCT00757666|O2|Outcome|Accelerometer|
1025257|NCT00757666|O1|Outcome|Minute Ventilation|
1025258|NCT00757666|E2|Reported Event|Minute Ventilation|Minute ventilation
1025259|NCT00757666|E1|Reported Event|Accelerometer|Accelerometer
1025260|NCT00757627|B1|Baseline|Etoricoxib|Etoricoxib 60 mg once a day (q.d.)
1025261|NCT00757627|P1|Participant Flow|Etoricoxib|Etoricoxib 60 mg once a day (q.d.)
1025262|NCT00757627|O1|Outcome|Etoricoxib 60 mg q.d.|
1025263|NCT00757627|O1|Outcome|Etoricoxib|Etoricoxib 60 mg q.d.
1025264|NCT00757627|O1|Outcome|Etoricoxib|Etoricoxib 60 mg q.d.
1025265|NCT00757627|O1|Outcome|Etoricoxib|Etoricoxib 60 mg q.d.
1025266|NCT00757627|O1|Outcome|Week 4 - EQ-5D|
1025267|NCT00757627|O1|Outcome|Baseline - EQ-5D|
1025268|NCT00757627|O1|Outcome|Etoricoxib|Etoricoxib 60 mg q.d.
1025269|NCT00757627|O1|Outcome|Etoricoxib (Week 4)|Etoricoxib 60 mg q.d.
1025270|NCT00757627|O1|Outcome|Etoricoxib (Baseline)|Etoricoxib 60 mg q.d.
1025271|NCT00757627|O1|Outcome|Etoricoxib|Etoricoxib 60 mg q.d.
1025272|NCT00757627|E1|Reported Event|Etoricoxib|Etoricoxib 60 mg once a day (q.d.)
1025274|NCT00757601|P12|Participant Flow|140mg MK1006/170mg MK1006/200mg MK1006/Placebo/260mg MK1006|Participants received 140 mg MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 260 mg MK1006 in Period 5.
1025275|NCT00757601|P11|Participant Flow|140mg MK1006/170mg MK1006/Placebo/230mg MK1006/260mg MK1006|Participants received 140 mg MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by 260 mg MK1006 in Period 5.
1025276|NCT00757601|P10|Participant Flow|Placebo/170mg MK1006/200mg MK1006/230mg MK1006/260mg MK1006|Participants received placebo to MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by 260 mg MK1006 in Period 5.
1025277|NCT00757601|P9|Participant Flow|140mg MK1006 / Placebo / 200mg MK1006 / 230mg MK1006 / Placebo|Participants received 140 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by placebo to MK1006 in Period 5
1025278|NCT00757601|P8|Participant Flow|60 mg MK1006/80 mg MK1006/100 mg MK1006/Placebo/140 mg MK1006|Participants received 60 mg MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 140 mg MK1006 in Period 5.
1025513|NCT00756964|P1|Participant Flow|Rasburicase Group|The drug rasburicase was used in this group.
1025279|NCT00757601|P7|Participant Flow|60mg MK1006/80mg MK1006/Placebo/120mg MK1006/140mg MK1006|Participants received 60 mg MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by 140 mg MK1006 in Period 5.
1025280|NCT00757601|P6|Participant Flow|Placebo/80mg MK1006/100mg MK1006/120mg MK1006/140mg MK1006|Participants received placebo to MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by 140 mg MK1006 in Period 5.
1025281|NCT00757601|P5|Participant Flow|60mg MK1006 / Placebo / 100mg MK1006 / 120mg MK1006 / Placebo|Participants received 60 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by placebo to MK1006 in Period 5.
1025282|NCT00757601|P4|Participant Flow|15mg MK1006/30mg MK1006/45mg MK1006/Placebo/30mg MK1006 (Fed)|Participants received 15 mg MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5.
1025283|NCT00757601|P3|Participant Flow|15mg MK1006/30mg MK1006/Placebo/60mg MK1006/30mg MK1006 (Fed)|Participants received 15 mg MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5.
1025284|NCT00757601|P2|Participant Flow|Placebo/30mg MK1006/45mg MK1006/60mg MK1006/30mg MK1006 (Fed)|Participants received placebo to MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5.
1025285|NCT00757601|P1|Participant Flow|15mg MK1006/Placebo/45mg MK1006/60mg MK1006/Placebo (Fed)|Participants received 15 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by placebo to MK1006 taken with food (Fed state) in Period 5.
1025286|NCT00757601|O13|Outcome|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
1025287|NCT00757601|O12|Outcome|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
1025288|NCT00757601|O11|Outcome|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
1025289|NCT00757601|O10|Outcome|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
1025290|NCT00757601|O9|Outcome|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
1025291|NCT00757601|O8|Outcome|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
1025292|NCT00757601|O7|Outcome|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
1025293|NCT00757601|O6|Outcome|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
1025294|NCT00757601|O5|Outcome|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
1025295|NCT00757601|O4|Outcome|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
1025296|NCT00757601|O3|Outcome|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
1025297|NCT00757601|O2|Outcome|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
1025298|NCT00757601|O1|Outcome|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
1025299|NCT00757601|O14|Outcome|Placebo|After a minimum washout period of 7 days, participants received a single dose of dose-matched placebo to MK1006.
1025300|NCT00757601|O13|Outcome|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
1025301|NCT00757601|O12|Outcome|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
1025302|NCT00757601|O11|Outcome|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
1025303|NCT00757601|O10|Outcome|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
1025304|NCT00757601|O9|Outcome|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
1025305|NCT00757601|O8|Outcome|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
1025307|NCT00757601|O6|Outcome|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
1025308|NCT00757601|O5|Outcome|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
1025309|NCT00757601|O4|Outcome|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
1025310|NCT00757601|O3|Outcome|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
1025311|NCT00757601|O2|Outcome|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
1025312|NCT00757601|O1|Outcome|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
1025313|NCT00757601|O13|Outcome|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
1025314|NCT00757601|O12|Outcome|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
1025315|NCT00757601|O11|Outcome|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
1025318|NCT00757601|O8|Outcome|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
1025319|NCT00757601|O7|Outcome|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
1025320|NCT00757601|O6|Outcome|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
1025321|NCT00757601|O5|Outcome|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
1025322|NCT00757601|O4|Outcome|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
1025323|NCT00757601|O3|Outcome|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
1025324|NCT00757601|O2|Outcome|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
1025325|NCT00757601|O1|Outcome|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
1025326|NCT00757601|O13|Outcome|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
1025327|NCT00757601|O12|Outcome|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
1025328|NCT00757601|O11|Outcome|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
1025329|NCT00757601|O10|Outcome|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
1025330|NCT00757601|O9|Outcome|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
1025331|NCT00757601|O8|Outcome|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
1025332|NCT00757601|O7|Outcome|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
1025333|NCT00757601|O6|Outcome|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
1025334|NCT00757601|O5|Outcome|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
1025335|NCT00757601|O4|Outcome|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
1025336|NCT00757601|O3|Outcome|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
1025337|NCT00757601|O2|Outcome|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
1025338|NCT00757601|O1|Outcome|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
1025339|NCT00757601|O13|Outcome|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
1025340|NCT00757601|O12|Outcome|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
1025341|NCT00757601|O11|Outcome|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
1025342|NCT00757601|O10|Outcome|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
1025343|NCT00757601|O9|Outcome|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
1025344|NCT00757601|O8|Outcome|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
1025345|NCT00757601|O7|Outcome|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
1025346|NCT00757601|O6|Outcome|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
1025347|NCT00757601|O5|Outcome|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
1025348|NCT00757601|O4|Outcome|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
1025349|NCT00757601|O3|Outcome|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
1025350|NCT00757601|O2|Outcome|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
1025351|NCT00757601|O1|Outcome|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
1025352|NCT00757601|O13|Outcome|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
1025353|NCT00757601|O12|Outcome|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
1025354|NCT00757601|O11|Outcome|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
1025355|NCT00757601|O10|Outcome|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
1025356|NCT00757601|O9|Outcome|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
1025357|NCT00757601|O8|Outcome|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
1025358|NCT00757601|O7|Outcome|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
1025359|NCT00757601|O6|Outcome|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
1025360|NCT00757601|O5|Outcome|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
1025361|NCT00757601|O4|Outcome|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
1025362|NCT00757601|O3|Outcome|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
1025363|NCT00757601|O2|Outcome|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
1025364|NCT00757601|O1|Outcome|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
1025365|NCT00757601|O14|Outcome|Placebo|After a minimum washout period of 7 days, participants received a single dose of dose-matched placebo to MK1006.
1025366|NCT00757601|O13|Outcome|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
1025367|NCT00757601|O12|Outcome|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
1025368|NCT00757601|O11|Outcome|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
1025369|NCT00757601|O10|Outcome|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
1025370|NCT00757601|O9|Outcome|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
1025371|NCT00757601|O8|Outcome|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
1025372|NCT00757601|O7|Outcome|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
1025373|NCT00757601|O6|Outcome|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
1025374|NCT00757601|O5|Outcome|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
1025375|NCT00757601|O4|Outcome|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
1025376|NCT00757601|O3|Outcome|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
1025377|NCT00757601|O2|Outcome|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
1025378|NCT00757601|O1|Outcome|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
1025379|NCT00757601|E14|Reported Event|Placebo|After a minimum washout period of 7 days, participants received a single dose of dose-matched placebo to MK1006.
1025380|NCT00757601|E13|Reported Event|30 mg MK1006 [Fed State]|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
1025381|NCT00757601|E12|Reported Event|260 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
1025382|NCT00757601|E11|Reported Event|230 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
1025383|NCT00757601|E10|Reported Event|200 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
1025384|NCT00757601|E9|Reported Event|170 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
1025385|NCT00757601|E8|Reported Event|140 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
1025386|NCT00757601|E7|Reported Event|120 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
1025387|NCT00757601|E6|Reported Event|100 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
1025388|NCT00757601|E5|Reported Event|80 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
1025389|NCT00757601|E4|Reported Event|60 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
1025390|NCT00757601|E3|Reported Event|45 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
1025391|NCT00757601|E2|Reported Event|30 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
1025392|NCT00757601|E1|Reported Event|15 mg MK1006|After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
1025393|NCT00757588|B3|Baseline|Total|Total of all reporting groups
1025394|NCT00757588|B2|Baseline|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025395|NCT00757588|B1|Baseline|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025396|NCT00757588|P2|Participant Flow|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025397|NCT00757588|P1|Participant Flow|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025398|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025399|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025400|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025401|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025402|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025403|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025404|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025405|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025406|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025407|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025408|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025409|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025410|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025411|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025412|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025413|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025414|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025415|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025416|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025417|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025418|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025419|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025420|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025421|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025422|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025423|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025424|NCT00757588|O2|Outcome|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025425|NCT00757588|O1|Outcome|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025426|NCT00757588|E2|Reported Event|Saxagliptin, 5 mg + Insulin|Saxagliptin, 5 mg, added to ongoing insulin with or without metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025427|NCT00757588|E1|Reported Event|Placebo + Insulin|Placebo added to ongoing insulin with metformin therapy for up to 24 weeks in patients with type 2 diabetes
1025428|NCT00757484|B1|Baseline|Women Who Underwent Gyneologic Surgery|All women who underwent inpatient Gynecologic surgery between Jan 2007 and 2008.
1025429|NCT00757484|P1|Participant Flow|Women Who Underwent Gynecologic Surgery|All women who underwent inpatient Gynecologic surgery between Jan 2007 and 2008.
1025430|NCT00757484|O1|Outcome|Women Who Underwent Gynecologic Surgery|All women who underwent inpatient Gynecologic surgery between Jan 2007 and 2008.
1025493|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
1025494|NCT00756977|O1|Outcome|BLI850|
1025431|NCT00757484|O1|Outcome|Women Who Underwent Gynecologic Surgery|All women who underwent inpatient Gynecologic surgery between Jan 2007 and 2008.
1025432|NCT00757484|O1|Outcome|Women Who Underwent GYN Surgery|All women who underwent inpatient GYN surgery between Jan 2007 and 2008.
1025433|NCT00757484|O1|Outcome|Women Who Underwent Scheduled Gynecologic Surgery|All women who underwent inpatient Gynecologic surgery between Jan 2007 and 2008. Measure is categorized by the type of surgery.
1025434|NCT00757484|E1|Reported Event|Women Who Underwent Gynecologic Surgery|All women who underwent inpatient gynecologic surgery between Jan 2007 and 2008.
1025435|NCT00757237|B3|Baseline|Total|Total of all reporting groups
1025436|NCT00757237|B2|Baseline|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
1025437|NCT00757237|B1|Baseline|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
1025438|NCT00757237|P2|Participant Flow|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
1025439|NCT00757237|P1|Participant Flow|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
1025440|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
1025441|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
1025442|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
1025443|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
1025444|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
1025445|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
1025446|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
1025447|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
1025448|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
1025449|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
1025450|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
1025451|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
1025452|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
1025453|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
1025454|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
1025455|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
1025456|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
1025457|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
1025458|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
1025459|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
1025460|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
1025461|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
1025462|NCT00757237|O2|Outcome|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
1025463|NCT00757237|O1|Outcome|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
1025464|NCT00757237|E2|Reported Event|TIS (300 mg BID)|TIS (300 mg/5 mL) was self-administered by inhalation two times a day (BID) for 28 days for each treatment cycle using the PARI LC PLUS(TM) Nebulizer with Compressor.
1025465|NCT00757237|E1|Reported Event|AZLI (75 mg TID)|AZLI (75 mg/1 mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day (TID) for 28 days for each treatment cycle using the investigational nebulizer.
1025514|NCT00756964|O2|Outcome|Placebo Group|The patients which received a placebo identical to rasburicase.
1025515|NCT00756964|O1|Outcome|Rasburicase Group|The patients received the drug rasburicase 7.5mg in 50mL of normal saline over 30 minutes period
1025466|NCT00757172|B1|Baseline|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
1025467|NCT00757172|P1|Participant Flow|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
1025468|NCT00757172|O1|Outcome|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
1025469|NCT00757172|O1|Outcome|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
1025470|NCT00757172|O1|Outcome|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
1025471|NCT00757172|O1|Outcome|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
1025472|NCT00757172|O1|Outcome|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
1025473|NCT00757172|E1|Reported Event|Docetaxel + Cisplatin + Panitumumab + RT|Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
1025474|NCT00757003|B1|Baseline|Treatment Arm - Placement of TAG Device|Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the pathology in the thoracic aorta. Pathology may include aneurysm, dissection, penetrating ulcer, pseudoaneurysm, false aneurysm, transection, mycotic aneurysm.
1025475|NCT00757003|P1|Participant Flow|Treatment Arm - Placement of TAG Device|Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the pathology in the thoracic aorta. Pathology may include aneurysm, dissection, penetrating ulcer, pseudoaneurysm, false aneurysm, transection, mycotic aneurysm.
1025476|NCT00757003|O1|Outcome|Treatment Arm - Placement of TAG Device|Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the pathology in the thoracic aorta. Pathology may include aneurysm, dissection, penetrating ulcer, pseudoaneurysm, false aneurysm, transection, mycotic aneurysm.
1025477|NCT00757003|O1|Outcome|Treatment Arm - Placement of TAG Device|"A TAG device will be placed in the Aorta to treat the AAA. A TAG device will be used to repair the aneurysm in the thoracic aorta~Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the aneurysm in the thoracic aorta"
1025478|NCT00757003|O1|Outcome|Treatment Arm - Placement of TAG Device|Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the pathology in the thoracic aorta. Pathology may include aneurysm, dissection, penetrating ulcer, pseudoaneurysm, false aneurysm, transection, mycotic aneurysm.
1025479|NCT00757003|E1|Reported Event|Treatment Arm - Placement of TAG Device|"A TAG device will be placed in the Aorta to treat the AAA. A TAG device will be used to repair the aneurysm in the thoracic aorta~Endovascular Stent-graft repair of descending thoracic aorta: A TAG device will be used to repair the aneurysm in the thoracic aorta"
1025480|NCT00756977|B3|Baseline|Total|Total of all reporting groups
1025481|NCT00756977|B2|Baseline|Polyethylene Glycol 3350 Based Bowel Preparation|
1025482|NCT00756977|B1|Baseline|BLI850|
1025483|NCT00756977|P2|Participant Flow|Polyethylene Glycol 3350 Based Bowel Preparation|Single administration oral preparation
1025484|NCT00756977|P1|Participant Flow|BLI850|Single administration oral preparation
1025485|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
1025486|NCT00756977|O1|Outcome|BLI850|
1025487|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
1025488|NCT00756977|O1|Outcome|BLI850|
1025489|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
1025490|NCT00756977|O1|Outcome|BLI850|
1025491|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
1025492|NCT00756977|O1|Outcome|BLI850|
1025495|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
1025496|NCT00756977|O1|Outcome|BLI850|
1025497|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
1025498|NCT00756977|O1|Outcome|BLI850|
1025499|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
1025500|NCT00756977|O1|Outcome|BLI850|
1025501|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
1025502|NCT00756977|O1|Outcome|BLI850|
1025503|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
1025504|NCT00756977|O1|Outcome|BLI850|
1025505|NCT00756977|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
1025506|NCT00756977|O1|Outcome|BLI850|
1025507|NCT00756977|E2|Reported Event|Polyethylene Glycol 3350 Based Bowel Preparation|
1025508|NCT00756977|E1|Reported Event|BLI850|
1025509|NCT00756964|B3|Baseline|Total|Total of all reporting groups
1025510|NCT00756964|B2|Baseline|Placebo Group|This group received an identical placebo of rasburicase.
1025511|NCT00756964|B1|Baseline|Rasburicase Group|The drug rasburicase was used in this group.
1025512|NCT00756964|P2|Participant Flow|Placebo Group|This group received an identical placebo of rasburicase.
1046364|NCT00704405|B6|Baseline|Total|Total of all reporting groups
1025516|NCT00756964|E2|Reported Event|Placebo Group|This group received an identical placebo of rasburicase.
1025517|NCT00756964|E1|Reported Event|Rasburicase Group|The drug rasburicase was used in this group.
1025518|NCT00756938|B4|Baseline|Total|Total of all reporting groups
1025519|NCT00756938|B3|Baseline|Losartan Potassium 0.7 to 1.4 mg/kg|Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
1025520|NCT00756938|B2|Baseline|Losartan Potassium 0.3 to 1.4 mg/kg|Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved
1025521|NCT00756938|B1|Baseline|Losartan Potassium 0.1 to 1.4 mg/kg|Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
1025522|NCT00756938|P4|Participant Flow|Losartan Potassium-Extension|Participants who elected to enter extension; dose level of Losartan was that which was being administered at end of base study
1025523|NCT00756938|P3|Participant Flow|Losartan Potassium 0.7 to 1.4 mg/kg|Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
1025524|NCT00756938|P2|Participant Flow|Losartan Potassium 0.3 to 1.4 mg/kg|Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved
1025525|NCT00756938|P1|Participant Flow|Losartan Potassium 0.1 to 1.4 mg/kg|Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
1025526|NCT00756938|O5|Outcome|Extension-Losartan Potassium|Open-label losartan at dose of 0.1, .03, .07 or 1.4 mg/kg/day
1025527|NCT00756938|O4|Outcome|Base Study-Losartan Potassium 1.4 mg/kg|Open-label losartan 1.4 mg/kg/day
1025528|NCT00756938|O3|Outcome|Base Study-Losartan Potassium 0.7 mg/kg|Open-label Losartan 0.7 mg/kg/day
1025529|NCT00756938|O2|Outcome|Base Study-Losartan Potassium 0.3 mg/kg|Open-label Losartan 0.3 mg/kg/day
1025530|NCT00756938|O1|Outcome|Base Study-Losartan Potassium 0.1 mg/kg|Open-label Losartan 0.1 mg/kg/day
1025531|NCT00756938|O5|Outcome|Extension-Losartan Potassium|Open-label losartan at dose of 0.1, .03, .07 or 1.4 mg/kg/day
1025532|NCT00756938|O4|Outcome|Base Study-Losartan Potassium 1.4 mg/kg|Open-label losartan 1.4 mg/kg/day
1025533|NCT00756938|O3|Outcome|Base Study-Losartan Potassium 0.7 mg/kg|Open-label Losartan 0.7 mg/kg/day
1025534|NCT00756938|O2|Outcome|Base Study-Losartan Potassium 0.3 mg/kg|Open-label Losartan 0.3 mg/kg/day
1025535|NCT00756938|O1|Outcome|Base Study-Losartan Potassium 0.1 mg/kg|Open-label Losartan 0.1 mg/kg/day
1025536|NCT00756938|O3|Outcome|Losartan Potassium 0.7 to 1.4 mg/kg|Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
1025537|NCT00756938|O2|Outcome|Losartan Potassium 0.3 to 1.4 mg/kg|Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved
1025538|NCT00756938|O1|Outcome|Losartan Potassium 0.1 to 1.4 mg/kg|Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
1025539|NCT00756938|O3|Outcome|Losartan Potassium 0.7 to 1.4 mg/kg|Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
1025540|NCT00756938|O2|Outcome|Losartan Potassium 0.3 to 1.4 mg/kg|Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved
1025541|NCT00756938|O1|Outcome|Losartan Potassium 0.1 to 1.4 mg/kg|Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
1025542|NCT00756938|E8|Reported Event|Extension-Losartan 1.4 mg/kg/Day|
1025543|NCT00756938|E7|Reported Event|Extension-Losartan 0.7 mg/kg/Day|
1025544|NCT00756938|E6|Reported Event|Extension-Losartan 0.3 mg/kg/Day|
1025545|NCT00756938|E5|Reported Event|Extension-Losartan 0.1 mg/kg/Day|
1025546|NCT00756938|E4|Reported Event|Base Study-Losartan 1.4 mg/kg/Day|
1025547|NCT00756938|E3|Reported Event|Base Study-Losartan Potassium 0.7 mg/kg/Day|
1025548|NCT00756938|E2|Reported Event|Base Study-Losartan Potassium 0.3 mg/kg/Day|
1025549|NCT00756938|E1|Reported Event|Base Study-Losartan Potassium 0.1 mg/kg/Day|
1025550|NCT00756886|B3|Baseline|Total|Total of all reporting groups
1025551|NCT00756886|B2|Baseline|Placebo|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
1025552|NCT00756886|B1|Baseline|Atorvastatin|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
1025553|NCT00756886|P2|Participant Flow|Placebo|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
1025554|NCT00756886|P1|Participant Flow|Atorvastatin|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
1025555|NCT00756886|O2|Outcome|Placebo|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
1025556|NCT00756886|O1|Outcome|Atorvastatin|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
1025557|NCT00756886|E2|Reported Event|Placebo|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
1025558|NCT00756886|E1|Reported Event|Atorvastatin|40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
1025559|NCT00756730|B3|Baseline|Total|Total of all reporting groups
1025560|NCT00756730|B2|Baseline|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
1025561|NCT00756730|B1|Baseline|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
1025608|NCT00756561|O2|Outcome|Serum Concentration|Serum hormone concentration in 10 normal men
1051424|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
1025562|NCT00756730|P2|Participant Flow|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
1025563|NCT00756730|P1|Participant Flow|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
1025564|NCT00756730|O2|Outcome|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
1025565|NCT00756730|O1|Outcome|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
1025566|NCT00756730|O2|Outcome|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
1025567|NCT00756730|O1|Outcome|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
1025568|NCT00756730|O2|Outcome|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
1025569|NCT00756730|O1|Outcome|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
1025570|NCT00756730|O2|Outcome|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
1025571|NCT00756730|O1|Outcome|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
1025572|NCT00756730|O2|Outcome|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
1025573|NCT00756730|O1|Outcome|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
1025574|NCT00756730|O2|Outcome|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
1025575|NCT00756730|O1|Outcome|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
1025576|NCT00756730|O2|Outcome|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
1025577|NCT00756730|O1|Outcome|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
1025578|NCT00756730|O2|Outcome|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
1025579|NCT00756730|O1|Outcome|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
1025580|NCT00756730|E2|Reported Event|Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
1025581|NCT00756730|E1|Reported Event|Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD|Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
1025582|NCT00756678|B1|Baseline|All Patients|All patients
1025583|NCT00756678|P1|Participant Flow|All Patients|All patients
1025584|NCT00756678|O2|Outcome|Lubricant Eye Drops (Blink® Tears)|Lubricant Eye Drops(blink® Tears)
1025585|NCT00756678|O1|Outcome|Lubricant Eye Drops (Optive™)|Lubricant Eye Drops (Optive™)
1025586|NCT00756678|O2|Outcome|Lubricant Eye Drops (Blink® Tears)|Lubricant Eye Drops(blink® Tears)
1025587|NCT00756678|O1|Outcome|Lubricant Eye Drops (Optive™)|Lubricant Eye Drops (Optive™)
1025588|NCT00756678|O2|Outcome|Lubricant Eye Drops (Blink® Tears)|Lubricant Eye Drops(blink® Tears)
1025589|NCT00756678|O1|Outcome|Lubricant Eye Drops (Optive™)|Lubricant Eye Drops (Optive™)
1025590|NCT00756678|O2|Outcome|Lubricant Eye Drops (Blink® Tears)|Lubricant Eye Drops(blink® Tears)
1025591|NCT00756678|O1|Outcome|Lubricant Eye Drops (Optive™)|Lubricant Eye Drops (Optive™)
1025592|NCT00756678|E1|Reported Event|All Patients|All patients
1025593|NCT00756574|B3|Baseline|Total|Total of all reporting groups
1025594|NCT00756574|B2|Baseline|2. N95 Respirator|N95 respirator
1025595|NCT00756574|B1|Baseline|1. Surgical|surgical mask
1025596|NCT00756574|P2|Participant Flow|2. N95 Respirator|N95 respirator
1025597|NCT00756574|P1|Participant Flow|1. Surgical|surgical mask
1025598|NCT00756574|O2|Outcome|2. N95 Respirator|N95 respirator
1025599|NCT00756574|O1|Outcome|1. Surgical|surgical mask
1025600|NCT00756574|O2|Outcome|2. N95 Respirator|N95 respirator
1025601|NCT00756574|O1|Outcome|1. Surgical|surgical mask
1025602|NCT00756574|O2|Outcome|2. N95 Respirator|N95 respirator
1025603|NCT00756574|O1|Outcome|1. Surgical|surgical mask
1025604|NCT00756574|O2|Outcome|2. N95 Respirator|N95 respirator
1025605|NCT00756574|O1|Outcome|1. Surgical|surgical mask
1025606|NCT00756561|B1|Baseline|Healthy Normal Males|Men, 18-50 years of age, in good health
1025607|NCT00756561|P1|Participant Flow|Healthy Normal Males|Men, 18-50 years of age, in good health
1025609|NCT00756561|O1|Outcome|Intratesticular Concentration|Average intratesticular hormone concentration between right and left testis in 10 normal men
1025610|NCT00756561|E1|Reported Event|Healthy Normal Males|Men, 18-50 years of age, in good health
1025611|NCT00756548|B3|Baseline|Total|Total of all reporting groups
1025612|NCT00756548|B2|Baseline|Polyethylene Glycol 3350 Based Bowel Preparation|
1025613|NCT00756548|B1|Baseline|BLI850|
1025614|NCT00756548|P2|Participant Flow|Polyethylene Glycol 3350 Based Bowel Preparation|single administration oral preparation - split dose
1025615|NCT00756548|P1|Participant Flow|BLI850|single administration oral preparation - split dose
1025616|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
1025617|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
1025618|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
1025619|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
1025620|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
1025621|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
1025622|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
1025623|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
1025624|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
1025625|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
1025626|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
1025627|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
1025628|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
1025629|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
1025630|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
1025631|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
1025632|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
1025633|NCT00756548|O1|Outcome|BLI850|
1025634|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|multi-dose preparation for oral administration
1025635|NCT00756548|O1|Outcome|BLI850|multi-dose preparation for oral administration
1025636|NCT00756548|O2|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|
1025637|NCT00756548|O1|Outcome|BLI850|
1025638|NCT00756548|E2|Reported Event|Polyethylene Glycol 3350 Based Bowel Preparation|
1025639|NCT00756548|E1|Reported Event|BLI850|
1025640|NCT00756470|B1|Baseline|Neoadjuvant Lapatinib Plus Chemotherapy|"Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil, Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.~Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.~Week 3 Paclitaxel 80 mg/m^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.~Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m2, epirubicin 75 mg/m^2, and Cyclophosphamide 500 mg/m^2 every 3 weeks for 4 cycles)."
1025641|NCT00756470|P1|Participant Flow|Neoadjuvant Lapatinib Plus Chemotherapy|"Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil (5FU), Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.~Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.~Week 3 Paclitaxel 80 mg/m^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.~Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m2, epirubicin 75 mg/m^2, and Cyclophosphamide 500 mg/m^2 every 3 weeks for 4 cycles)."
1025665|NCT00756457|O3|Outcome|Brace & Exercise (6 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment.
1025841|NCT00755846|B2|Baseline|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
1029075|NCT00746733|O4|Outcome|Adderall XR + Prilosec OTC|
1025642|NCT00756470|O1|Outcome|Neoadjuvant Lapatinib Plus Chemotherapy|"Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil, Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.~Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.~Week 3 Paclitaxel 80 mg/m^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.~Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m2, epirubicin 75 mg/m^2, and Cyclophosphamide 500 mg/m^2 every 3 weeks for 4 cycles)."
1025643|NCT00756470|O1|Outcome|Neoadjuvant Lapatinib Plus Chemotherapy|"Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil, Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.~Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.~Week 3 Paclitaxel 80 mg/m^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.~Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m2, epirubicin 75 mg/m^2, and Cyclophosphamide 500 mg/m^2 every 3 weeks for 4 cycles)."
1025673|NCT00756457|O1|Outcome|Brace & Exercise (Baseline)|This group based on the inclusion exclusion criteria were classified as stage II PTTD.
1025674|NCT00756457|E2|Reported Event|Brace|Participants in Group B will undergo bracing and perform stretching and strengthening exercises.
1025675|NCT00756457|E1|Reported Event|Brace & Exercise|Participants in Group A will undergo bracing and perform stretching exercises.
1025644|NCT00756470|E1|Reported Event|Neoadjuvant Lapatinib Plus Chemotherapy|"Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil, Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.~Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.~Week 3 Paclitaxel 80 mg/m^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily.~Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m2, epirubicin 75 mg/m^2, and Cyclophosphamide 500 mg/m^2 every 3 weeks for 4 cycles)."
1025645|NCT00756457|B3|Baseline|Total|Total of all reporting groups
1025646|NCT00756457|B2|Baseline|Brace|Participants in Group B will undergo bracing and perform stretching and strengthening exercises.
1025647|NCT00756457|B1|Baseline|Brace & Exercise|Participants in Group A will undergo bracing and perform stretching exercises.
1025648|NCT00756457|P2|Participant Flow|Brace|Participants in Group B will undergo bracing and perform stretching and strengthening exercises.
1025649|NCT00756457|P1|Participant Flow|Brace & Exercise|Participants in Group A will undergo bracing and perform stretching exercises.
1025650|NCT00756457|O6|Outcome|Brace (12 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and another resumed cancer treatments bringing the total to 17.
1025651|NCT00756457|O5|Outcome|Brace & Exercise (12 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment bringing the total to 19.
1025652|NCT00756457|O4|Outcome|Brace (6 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and another resumed cancer treatments bringing the total to 17.
1025653|NCT00756457|O3|Outcome|Brace & Exercise (6 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment bringing the total to 19.
1025654|NCT00756457|O2|Outcome|Brace (Baseline)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and another resumed cancer treatments bringing the total to 17.
1025655|NCT00756457|O1|Outcome|Brace & Exercise (Baseline)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment bringing the total to 19.
1025656|NCT00756457|O6|Outcome|Brace (12 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and the other resumed cancer treatments bringing the total to 17.
1025657|NCT00756457|O5|Outcome|Brace & Exercise (12 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment.
1025658|NCT00756457|O4|Outcome|Brace (6 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and the other resumed cancer treatments bringing the total to 17.
1025659|NCT00756457|O3|Outcome|Brace & Exercise (6 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment.
1025660|NCT00756457|O2|Outcome|Brace (Baseline)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and the other resumed cancer treatments bringing the total to 17.
1025661|NCT00756457|O1|Outcome|Brace & Exercise (Baseline)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment.
1025662|NCT00756457|O6|Outcome|Brace (12 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and another resumed cancer treatments bringing the total to 17.
1025663|NCT00756457|O5|Outcome|Brace & Exercise (12 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment.
1025664|NCT00756457|O4|Outcome|Brace (6 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and another resumed cancer treatments bringing the total to 17.
1025666|NCT00756457|O2|Outcome|Brace (Baseline)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant moved overseas and another resumed cancer treatments bringing the total to 17.
1025667|NCT00756457|O1|Outcome|Brace & Exercise (Baseline)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD. Only the participants that completed the study are included here. One participant opted to have surgery after 2 weeks of treatment.
1025668|NCT00756457|O6|Outcome|Brace (12 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD.
1025669|NCT00756457|O5|Outcome|Brace & Exercise (12 Weeks)|This group based on the inclusion exclusion criteria were classified as stage II PTTD.
1025670|NCT00756457|O4|Outcome|Brace (6 Weeks)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD.
1025671|NCT00756457|O3|Outcome|Brace & Exercise (6 Weeks)|This group based on the inclusion exclusion criteria were classified as stage II PTTD.
1025672|NCT00756457|O2|Outcome|Brace (Baseline)|This group based on the inclusion and exclusion criteria was classified as having stage II PTTD.
1025677|NCT00756444|B2|Baseline|Chemotherapy Alone|Treatment will be administered in cycles repeated every 21 days. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
1025678|NCT00756444|B1|Baseline|Panitumumab Plus Chemotherapy|Treatment will be administered in cycles repeated every 21 days. On day 1 of each cycle, panitumumab will be administered intravenously, prior to chemotherapy, at a dose of 9 mg/kg over 1 hour. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
1025679|NCT00756444|P2|Participant Flow|Chemotherapy Alone|Treatment will be administered in cycles repeated every 21 days. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
1025680|NCT00756444|P1|Participant Flow|Panitumumab Plus Chemotherapy|Treatment will be administered in cycles repeated every 21 days. On day 1 of each cycle, panitumumab will be administered intravenously, prior to chemotherapy, at a dose of 9 mg/kg over 1 hour. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
1025681|NCT00756444|O2|Outcome|Chemotherapy Alone|Treatment will be administered in cycles repeated every 21 days. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
1025682|NCT00756444|O1|Outcome|Panitumuab Plus Chemotherapy|Treatment will be administered in cycles repeated every 21 days. On day 1 of each cycle, panitumumab will be administered intravenously, prior to chemotherapy, at a dose of 9 mg/kg over 1 hour. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
1025683|NCT00756444|O2|Outcome|Chemotherapy Alone|Treatment will be administered in cycles repeated every 21 days. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
1025684|NCT00756444|O1|Outcome|Panitumuab Plus Chemotherapy|Treatment will be administered in cycles repeated every 21 days. On day 1 of each cycle, panitumumab will be administered intravenously, prior to chemotherapy, at a dose of 9 mg/kg over 1 hour. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
1025685|NCT00756444|E3|Reported Event|Total|
1025686|NCT00756444|E2|Reported Event|Chemotherapy Alone|Treatment will be administered in cycles repeated every 21 days. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
1025687|NCT00756444|E1|Reported Event|Panitumumab Plus Chemotherapy|Treatment will be administered in cycles repeated every 21 days. On day 1 of each cycle, panitumumab will be administered intravenously, prior to chemotherapy, at a dose of 9 mg/kg over 1 hour. Cisplatin will be administered intravenously on day 1 at a dose of 100 mg/m2 over 1 hour. 5-FU will be administered at a dose of 1000 mg/m2/day by continuous intravenous infusion on day 1 to 4 (96 hours).
1025688|NCT00756314|B3|Baseline|Total|Total of all reporting groups
1025689|NCT00756314|B2|Baseline|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
1025690|NCT00756314|B1|Baseline|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
1025691|NCT00756314|P2|Participant Flow|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
1025692|NCT00756314|P1|Participant Flow|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
1025693|NCT00756314|O2|Outcome|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
1025694|NCT00756314|O1|Outcome|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
1025695|NCT00756314|O2|Outcome|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
1025696|NCT00756314|O1|Outcome|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
1025697|NCT00756314|O2|Outcome|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
1025698|NCT00756314|O1|Outcome|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
1025699|NCT00756314|O2|Outcome|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
1025700|NCT00756314|O1|Outcome|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
1025701|NCT00756314|O2|Outcome|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
1025702|NCT00756314|O1|Outcome|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
1025703|NCT00756314|E2|Reported Event|Control|All women allocated to control group received a standard care available at IMIP.Standard care is comprised of educational group counseling by specialized nursing staff in family planning discussing about contraceptive methods and side effects
1025704|NCT00756314|E1|Reported Event|Personalized Contraceptive Counseling|All allocated women for the intervention group received personalized counseling (face-to-face) and the contraceptive method chosen for free by a specialized trained doctor in family planning.
1025705|NCT00756093|B1|Baseline|Overall Study|
1025706|NCT00756093|P4|Participant Flow|GenTeal Moderate, Then Systane, Then Optive, Then Blink Tears|Patients received GenTeal Moderate first, then Systane, then Optive, then Blink Tears last
1025707|NCT00756093|P3|Participant Flow|Blink Tears, Then GenTeal Moderate, Then Systane, Then Optive|Patients received Blink Tears first, then GenTeal Moderate, then Systane, then Optive last
1025708|NCT00756093|P2|Participant Flow|Optive, Then Blink Tears, Then GenTeal Moderate, Then Systane|Patients received Optive first, then Blink Tears, then GenTeal Moderate, then Systane
1025709|NCT00756093|P1|Participant Flow|Systane, Then Optive, Then Blink Tears, Then GenTeal Moderate|Pateints received Systane first, then Optive, then Blink Tears, then GenTeal Moderate last.
1025710|NCT00756093|O4|Outcome|GenTeal Moderate Lubricant Eye Drops|GenTeal Moderate Lubricant Eye Drops
1025711|NCT00756093|O3|Outcome|Blink Tears|Blink Tears
1025712|NCT00756093|O2|Outcome|Optive Lubricant Eye Drops|Optive Lubricant Eye Drops
1025713|NCT00756093|O1|Outcome|Systane Ultra Lubricant Eye Drops|Systane Ultra Lubricant Eye Drops
1025714|NCT00756093|E4|Reported Event|GenTeal Moderate Lubricant Eye Drops|GenTeal Moderate Lubricant Eye Drops
1025715|NCT00756093|E3|Reported Event|Blink Tears|Blink Tears
1025716|NCT00756093|E2|Reported Event|Optive Lubricant Eye Drops|Optive Lubricant Eye Drops
1025717|NCT00756093|E1|Reported Event|Systane Ultra Lubricant Eye Drops|Systane Ultra Lubricant Eye Drops
1025718|NCT00756002|B3|Baseline|Total|Total of all reporting groups
1025719|NCT00756002|B2|Baseline|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025720|NCT00756002|B1|Baseline|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025721|NCT00756002|P2|Participant Flow|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025722|NCT00756002|P1|Participant Flow|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025723|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025724|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025725|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025726|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025727|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025728|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025729|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025840|NCT00755846|B3|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
1025730|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025731|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025732|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025733|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025734|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025735|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025736|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025737|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025854|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
1025738|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025739|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025740|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025741|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025742|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025743|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025744|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025745|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025746|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025747|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025748|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025749|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025750|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025751|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025752|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025753|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025754|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025755|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025756|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025757|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025758|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025759|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025760|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025761|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025762|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025763|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025764|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025765|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025766|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025767|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025768|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025769|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025770|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025771|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025772|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025773|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025774|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025775|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025776|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025777|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025778|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025779|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025780|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025781|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025782|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025783|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025784|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025785|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025786|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025787|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025788|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025789|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025790|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025791|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025792|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025793|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025794|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025795|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025796|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025797|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025798|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025799|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025800|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025801|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025802|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025803|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025804|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025805|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025806|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025807|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025808|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025809|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025810|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025811|NCT00756002|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025812|NCT00756002|O1|Outcome|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025813|NCT00756002|E2|Reported Event|Ramelteon 4 mg QD|Ramelteon 4 mg tablets, self-administered once-daily, 30 minutes prior to bedtime. Study medication consisted of identical film-coated pale orange-yellow tablets.
1025814|NCT00756002|E1|Reported Event|Placebo QD|Oral Placebo was self-administered once-daily, 30 minutes prior to bedtime. The study medication consisted of identical film-coated pale orange-yellow tablets.
1025815|NCT00755937|B1|Baseline|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
1025816|NCT00755937|P1|Participant Flow|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
1025817|NCT00755937|O1|Outcome|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
1025818|NCT00755937|O1|Outcome|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
1025819|NCT00755937|O1|Outcome|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
1025820|NCT00755937|O1|Outcome|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
1025821|NCT00755937|O1|Outcome|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
1025822|NCT00755937|O1|Outcome|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
1025823|NCT00755937|O1|Outcome|Subjects Receiving Remicade|Crohn's disease subjects who were to receive Remicade® per Product Monograph.
1025824|NCT00755937|E1|Reported Event|Subjects Receiving Remicade|
1025825|NCT00755911|B3|Baseline|Total|Total of all reporting groups
1025826|NCT00755911|B2|Baseline|Control|Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
1025827|NCT00755911|B1|Baseline|Treatment|Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier
1025828|NCT00755911|P2|Participant Flow|Control|Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
1025829|NCT00755911|P1|Participant Flow|Treatment|Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier
1025830|NCT00755911|O2|Outcome|Control|Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
1025831|NCT00755911|O1|Outcome|Tissue Repair Cells (TRC)|Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier
1025832|NCT00755911|O2|Outcome|Control|Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
1025833|NCT00755911|O1|Outcome|Tissue Repair Cells (TRC)|Subjects will receive Tissue Repair Cell (TRC) therapy plus Gelfoam carrier
1025834|NCT00755911|E2|Reported Event|Sham Comparator: Control|Subjects will receive the control treatment, consisting of Gelfoam carrier without Tissue Repair Cell (TRC) therapy.
1025835|NCT00755911|E1|Reported Event|Experimental: Tissue Repair Cell (TRC)|Subjects will receive TRC therapy plus Gelfoam carrier
1025836|NCT00755846|B7|Baseline|Total|Total of all reporting groups
1025837|NCT00755846|B6|Baseline|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
1025838|NCT00755846|B5|Baseline|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
1025839|NCT00755846|B4|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
1027165|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
1025842|NCT00755846|B1|Baseline|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
1025843|NCT00755846|P6|Participant Flow|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
1025844|NCT00755846|P5|Participant Flow|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
1025845|NCT00755846|P4|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
1025846|NCT00755846|P3|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
1025847|NCT00755846|P2|Participant Flow|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
1025848|NCT00755846|P1|Participant Flow|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
1025849|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
1025850|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
1025851|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
1025852|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
1025853|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
1051425|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
1025855|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
1025856|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
1025857|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
1025858|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
1025859|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
1025860|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
1025861|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
1025862|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
1025863|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
1025864|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
1025865|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
1025866|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
1025867|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
1025868|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
1025869|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
1025870|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
1025871|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
1025872|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
1025873|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
1025874|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
1025875|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
1025876|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
1025877|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
1025878|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
1025879|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
1025880|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
1025881|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
1025882|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
1025883|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
1025884|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
1025885|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
1025886|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
1025887|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
1025888|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
1025889|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
1025890|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
1025891|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
1025892|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
1025893|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
1025894|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
1025895|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
1029076|NCT00746733|O3|Outcome|Vyvanse + Prilosec OTC|
1025896|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
1025897|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
1025898|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
1025899|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
1025900|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
1025901|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
1025902|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
1025903|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
1025904|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
1025905|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
1025906|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
1025907|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
1025908|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
1025909|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
1025910|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
1025911|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
1025912|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
1025913|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
1025914|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
1025915|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
1025916|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
1025917|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
1025918|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
1025919|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
1025920|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
1025921|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
1025922|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
1025923|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
1025924|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
1025925|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
1025926|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
1025927|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
1025928|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
1025929|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
1025930|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
1025931|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
1025932|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
1025933|NCT00755846|O6|Outcome|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
1025934|NCT00755846|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
1025935|NCT00755846|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
1025936|NCT00755846|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
1025937|NCT00755846|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
1025938|NCT00755846|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
1025939|NCT00755846|E6|Reported Event|Alogliptin 100 mg QD|Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
1025940|NCT00755846|E5|Reported Event|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
1025941|NCT00755846|E4|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
1025942|NCT00755846|E3|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
1025943|NCT00755846|E2|Reported Event|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
1025944|NCT00755846|E1|Reported Event|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
1025945|NCT00755807|B3|Baseline|Total|Total of all reporting groups
1025946|NCT00755807|B2|Baseline|Placebo|Participants received placebo po, QD for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
1025947|NCT00755807|B1|Baseline|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
1025948|NCT00755807|P2|Participant Flow|Placebo|Participants received placebo po, QD for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
1025949|NCT00755807|P1|Participant Flow|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
1025950|NCT00755807|O1|Outcome|Duloxetine|60 mg oral, once daily (QD) for 6-weeks (acute phase) followed by 60, 90, or 120 mg QD for 12-weeks (open label extension phase).
1025951|NCT00755807|O1|Outcome|Duloxetine|60 mg oral, once daily (QD) for 6-weeks (acute phase) followed by 60, 90, or 120 mg QD for 12-weeks (open label extension phase).
1025952|NCT00755807|O1|Outcome|Duloxetine|60 mg oral, once daily (QD) for 6-weeks (acute phase) followed by 60, 90, or 120 mg QD for 12-weeks (open label extension phase).
1025953|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
1025954|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
1025955|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
1025956|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
1025957|NCT00755807|O1|Outcome|Duloxetine|60 mg oral, once daily (QD) for 6-weeks (acute phase) followed by 60, 90, or 120 mg QD for 12-weeks (open label extension phase).
1025958|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
1025959|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
1025960|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
1025961|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
1025962|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
1025963|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
1025964|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
1025965|NCT00755807|O1|Outcome|Duloxetine|All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase).
1025966|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
1025967|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
1025968|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
1025969|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
1025970|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
1025971|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
1025972|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
1025973|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
1025974|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
1025975|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
1025976|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
1025977|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
1025978|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
1025979|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
1025980|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
1025981|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
1025982|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
1025983|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
1026028|NCT00755417|B1|Baseline|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
1025984|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
1025985|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
1025986|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
1025987|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
1025988|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
1025989|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
1025990|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
1025991|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
1025992|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
1025993|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
1025994|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
1025995|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
1025996|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
1025997|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
1025998|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
1025999|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
1026000|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
1026001|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
1026002|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
1026003|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
1026004|NCT00755807|O2|Outcome|Placebo|Participants received placebo (po, QD) for 6 weeks (acute phase).
1026005|NCT00755807|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) duloxetine (oral [po], once daily [QD]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period.
1026006|NCT00755807|E3|Reported Event|Duloxetine - Open-label Extension Phase|Participants previously receiving duloxetine or placebo in the double-blind acute phase received duloxetine 60, 90, or 120 mg QD for 12 weeks (open label extension phase)
1026007|NCT00755807|E2|Reported Event|Placebo - Double-Blind Acute Phase|Oral, QD for 6 weeks
1026008|NCT00755807|E1|Reported Event|Duloxetine - Double-Blind Acute Phase|60 mg oral (po), once daily (QD) for 6 weeks (acute phase)
1026009|NCT00755755|B4|Baseline|Total|Total of all reporting groups
1026010|NCT00755755|B3|Baseline|C (Placebo)|PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
1026011|NCT00755755|B2|Baseline|B (PGL4001 10mg)|PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
1026012|NCT00755755|B1|Baseline|A (PGL4001 5mg)|PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
1026013|NCT00755755|P3|Participant Flow|C (Placebo)|PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
1026014|NCT00755755|P2|Participant Flow|B (PGL4001 10mg)|PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
1026015|NCT00755755|P1|Participant Flow|A (PGL4001 5mg)|PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
1026016|NCT00755755|O3|Outcome|C (Placebo)|PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
1026017|NCT00755755|O2|Outcome|B (PGL4001 10mg)|PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
1026018|NCT00755755|O1|Outcome|A (PGL4001 5mg)|PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
1026019|NCT00755755|O3|Outcome|C (Placebo)|PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
1026020|NCT00755755|O2|Outcome|B (PGL4001 10mg)|PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
1026021|NCT00755755|O1|Outcome|A (PGL4001 5mg)|PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
1026022|NCT00755755|E3|Reported Event|C (Placebo)|PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
1026023|NCT00755755|E2|Reported Event|B (PGL4001 10mg)|PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
1026024|NCT00755755|E1|Reported Event|A (PGL4001 5mg)|PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
1026025|NCT00755417|B4|Baseline|Total|Total of all reporting groups
1026026|NCT00755417|B3|Baseline|Sugar Pill|Placebo 1200 mg or 1800 mg
1026027|NCT00755417|B2|Baseline|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
1026029|NCT00755417|P3|Participant Flow|Sugar Pill|Placebo 1200 mg or 1800 mg
1026030|NCT00755417|P2|Participant Flow|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
1026031|NCT00755417|P1|Participant Flow|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
1026032|NCT00755417|O3|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
1026033|NCT00755417|O2|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
1026034|NCT00755417|O1|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
1026035|NCT00755417|O3|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
1026036|NCT00755417|O2|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
1026037|NCT00755417|O1|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
1026038|NCT00755417|O3|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
1026039|NCT00755417|O2|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
1026040|NCT00755417|O1|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
1026041|NCT00755417|O3|Outcome|Sugar Pill|Placebo 1200 mg or 1800 mg
1026042|NCT00755417|O2|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
1026043|NCT00755417|O1|Outcome|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
1026044|NCT00755417|E3|Reported Event|Sugar Pill|Placebo 1200 mg or 1800 mg
1026045|NCT00755417|E2|Reported Event|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
1026046|NCT00755417|E1|Reported Event|G-ER 1200 mg|Gabapentin extended-release (G-ER) 1200 mg
1026047|NCT00755274|B3|Baseline|Total|Total of all reporting groups
1026048|NCT00755274|B2|Baseline|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
1026049|NCT00755274|B1|Baseline|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
1026050|NCT00755274|P2|Participant Flow|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
1026051|NCT00755274|P1|Participant Flow|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
1026052|NCT00755274|O2|Outcome|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
1026053|NCT00755274|O1|Outcome|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
1026054|NCT00755274|O2|Outcome|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
1026055|NCT00755274|O1|Outcome|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
1026056|NCT00755274|O2|Outcome|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
1026057|NCT00755274|O1|Outcome|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
1026058|NCT00755274|O2|Outcome|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
1026059|NCT00755274|O1|Outcome|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
1026285|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8mg /kg iv every 4 weeks for a total of 6 infusions.
1029077|NCT00746733|O2|Outcome|Adderall XR|
1026060|NCT00755274|O2|Outcome|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
1026061|NCT00755274|O1|Outcome|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
1026062|NCT00755274|O2|Outcome|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
1026063|NCT00755274|O1|Outcome|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
1026064|NCT00755274|O2|Outcome|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
1026518|NCT00754130|O1|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
1026065|NCT00755274|O1|Outcome|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
1026066|NCT00755274|O2|Outcome|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
1026067|NCT00755274|O1|Outcome|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
1026068|NCT00755274|E2|Reported Event|Naive/Inadequately Primed Group|Participants never received or received only 1 lifetime influenza vaccination prior to Visit 1. They received one intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1 and a second dose at Visit 2.
1026069|NCT00755274|E1|Reported Event|Primed Group|Participants had received 2 or more lifetime influenza vaccinations prior to Visit 1. They received a single intramuscular dose of Fluzone® (0.25 mL for those aged 6-35 months and 0.5 mL for those aged 36-59 months) at Visit 1.
1026070|NCT00755261|B1|Baseline|Avastin and Doxorubicin|"Patients will be treated with Avastin 15 mg/kg IV infusion plus doxorubicin 60 mg/M2 (body surface area) IV 6-hour infusion on Day 1 of each 21-day treatment cycle. Dose reductions/modifications will be applied as indicated by toxicities and/or patient tolerance.~Avastin: Combination of Avastin and doxorubicin. If initial 90 +/- 15 minute infusion of Avastin is tolerated without fever and chills, the 2nd dose may be infused over 60 +/- 10 minutes. If well tolerated, all subsequent infusions may be delivered over 30 +/- 10 minutes.~Doxorubicin: The Day 1 6- hour continuous IV infusion must be done through a central venous catheter."
1026071|NCT00755261|P1|Participant Flow|Avastin and Doxorubicin|"Patients will be treated with Avastin 15 mg/kg IV infusion plus doxorubicin 60 mg/M2 (body surface area) IV 6-hour infusion on Day 1 of each 21-day treatment cycle. Dose reductions/modifications will be applied as indicated by toxicities and/or patient tolerance.~Avastin: Combination of Avastin and doxorubicin. If initial 90 +/- 15 minute infusion of Avastin is tolerated without fever and chills, the 2nd dose may be infused over 60 +/- 10 minutes. If well tolerated, all subsequent infusions may be delivered over 30 +/- 10 minutes.~Doxorubicin: The Day 1 6- hour continuous IV infusion must be done through a central venous catheter."
1026072|NCT00755261|O1|Outcome|Avastin and Doxorubicin|"Patients will be treated with Avastin 15 mg/kg IV infusion plus doxorubicin 60 mg/M2 (body surface area) IV 6-hour infusion on Day 1 of each 21-day treatment cycle. Dose reductions/modifications will be applied as indicated by toxicities and/or patient tolerance.~Avastin: Combination of Avastin and doxorubicin. If initial 90 +/- 15 minute infusion of Avastin is tolerated without fever and chills, the 2nd dose may be infused over 60 +/- 10 minutes. If well tolerated, all subsequent infusions may be delivered over 30 +/- 10 minutes.~Doxorubicin: The Day 1 6- hour continuous IV infusion must be done through a central venous catheter."
1026073|NCT00755261|E1|Reported Event|Avastin and Doxorubicin|"Patients will be treated with Avastin 15 mg/kg IV infusion plus doxorubicin 60 mg/M2 (body surface area) IV 6-hour infusion on Day 1 of each 21-day treatment cycle. Dose reductions/modifications will be applied as indicated by toxicities and/or patient tolerance.~Avastin: Combination of Avastin and doxorubicin. If initial 90 +/- 15 minute infusion of Avastin is tolerated without fever and chills, the 2nd dose may be infused over 60 +/- 10 minutes. If well tolerated, all subsequent infusions may be delivered over 30 +/- 10 minutes.~Doxorubicin: The Day 1 6- hour continuous IV infusion must be done through a central venous catheter."
1026074|NCT00755235|B3|Baseline|Total|Total of all reporting groups
1026075|NCT00755235|B2|Baseline|Usual Care|Participants will receive their usual care, with no additional education or care management services.
1026076|NCT00755235|B1|Baseline|Secure Messaging Care Management|Participants will receive depression care management by secure messaging.
1026077|NCT00755235|P2|Participant Flow|Usual Care|Participants will receive their usual care, with no additional education or care management services.
1026078|NCT00755235|P1|Participant Flow|Secure Messaging Care Management|Participants will receive depression care management by secure messaging.
1026079|NCT00755235|O2|Outcome|Usual Care|Participants will receive their usual care, with no additional education or care management services.
1026080|NCT00755235|O1|Outcome|Secure Messaging Care Management|Participants will receive depression care management by secure messaging.
1026081|NCT00755235|O2|Outcome|Usual Care|Participants will receive their usual care, with no additional education or care management services.
1026082|NCT00755235|O1|Outcome|Secure Messaging Care Management|Participants will receive depression care management by secure messaging.
1026083|NCT00755235|E2|Reported Event|Usual Care|Participants will receive their usual care, with no additional education or care management services.
1026084|NCT00755235|E1|Reported Event|Secure Messaging Care Management|Participants will receive depression care management by secure messaging.
1026085|NCT00755222|B3|Baseline|Total|Total of all reporting groups
1026086|NCT00755222|B2|Baseline|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
1026087|NCT00755222|B1|Baseline|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
1026088|NCT00755222|P2|Participant Flow|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
1026111|NCT00755131|P1|Participant Flow|Exercise Training Group|Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program
1026112|NCT00755131|O2|Outcome|Control Group|Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.
1057132|NCT00675766|B3|Baseline|Group 3|HIV-negative controls 50 and older
1026089|NCT00755222|P1|Participant Flow|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
1026090|NCT00755222|O2|Outcome|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
1026091|NCT00755222|O1|Outcome|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
1026092|NCT00755222|O2|Outcome|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
1026093|NCT00755222|O1|Outcome|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
1026094|NCT00755222|O2|Outcome|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
1026095|NCT00755222|O1|Outcome|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
1026096|NCT00755222|O2|Outcome|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
1026097|NCT00755222|O1|Outcome|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
1026098|NCT00755222|O2|Outcome|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
1026099|NCT00755222|O1|Outcome|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
1026100|NCT00755222|E2|Reported Event|Placebo|Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
1026101|NCT00755222|E1|Reported Event|AA4500|Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
1026102|NCT00755196|B1|Baseline|AN2728 5% Ointment + Ointment Vehicle|AN2728 5 % ointment and ointment vehicle were applied to 2 comparable and anatomically distinct treatment-targeted plaques, respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
1026103|NCT00755196|P1|Participant Flow|AN2728 5 Percent (%) Ointment + Ointment Vehicle|AN2728 5 % ointment and ointment vehicle were applied to 2 comparable and anatomically distinct treatment-targeted plaques, respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
1026104|NCT00755196|O1|Outcome|AN2728 5% Ointment + Ointment Vehicle|AN2728 5 % ointment and ointment vehicle were applied to 2 comparable and anatomically distinct treatment­ targeted plaques, respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
1027166|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
1026105|NCT00755196|O1|Outcome|AN2728 5% Ointment + Ointment Vehicle|AN2728 5 % ointment and ointment vehicle were applied to 2 comparable and anatomically distinct treatment-targeted plaques, respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
1026106|NCT00755196|E1|Reported Event|AN2728 5% Ointment + Ointment Vehicle|AN2728 5 % ointment and ointment vehicle were applied to 2 comparable and anatomically distinct treatment-targeted plaques, respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
1026107|NCT00755131|B3|Baseline|Total|Total of all reporting groups
1026108|NCT00755131|B2|Baseline|Control Group|Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.
1026109|NCT00755131|B1|Baseline|Exercise Training Group|Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program
1026110|NCT00755131|P2|Participant Flow|Control Group|Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.
1026113|NCT00755131|O1|Outcome|Exercise Training Group|Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program
1026114|NCT00755131|O2|Outcome|Control Group|Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.
1026115|NCT00755131|O1|Outcome|Exercise Training Group|Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program
1026116|NCT00755131|O2|Outcome|Control Group|Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.
1026117|NCT00755131|O1|Outcome|Exercise Training Group|Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program
1026118|NCT00755131|E2|Reported Event|Control Group|Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.
1026119|NCT00755131|E1|Reported Event|Exercise Training Group|Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program
1026120|NCT00755105|B4|Baseline|Total|Total of all reporting groups
1026121|NCT00755105|B3|Baseline|Postmenopausal Women Having Consumed Iron-55 Tracer|
1026122|NCT00755105|B2|Baseline|Menstruating Women Having Consumed Iron-55 Tracer|Includes women on hormonal contraceptives
1026123|NCT00755105|B1|Baseline|Male Subjects Having Consumed Iron-55 Tracer|
1026124|NCT00755105|P3|Participant Flow|Postmenopausal Women Having Consumed Iron-55 Tracer|
1026125|NCT00755105|P2|Participant Flow|Menstruating Women Having Consumed Iron-55 Tracer|Includes women on hormonal contraceptives
1026126|NCT00755105|P1|Participant Flow|Male Subjects Having Consumed Iron-55 Tracer|
1026127|NCT00755105|O3|Outcome|Postmenopausal Women Having Consumed Iron-55 Tracer|
1026128|NCT00755105|O2|Outcome|Menstruating Women Having Consumed Iron-55 Tracer|Includes women on hormonal contraceptives
1026129|NCT00755105|O1|Outcome|Male Subjects Having Consumed Iron-55 Tracer|
1026130|NCT00755105|E3|Reported Event|Postmenopausal Women Having Consumed Iron-55 Tracer|
1026131|NCT00755105|E2|Reported Event|Menstruating Women Having Consumed Iron-55 Tracer|Includes women on hormonal contraceptives
1026132|NCT00755105|E1|Reported Event|Male Subjects Having Consumed Iron-55 Tracer|
1026133|NCT00755079|B3|Baseline|Total|Total of all reporting groups
1026134|NCT00755079|B2|Baseline|Active Drug|"group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule~extended release beta-2 adrenergic agonist: Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles."
1026135|NCT00755079|B1|Baseline|Placebo|"group of persons with spinal cord injury will receive blinded placebo capsule~placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function."
1026136|NCT00755079|P2|Participant Flow|Active Drug|"group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule~extended release beta-2 adrenergic agonist: Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles."
1026137|NCT00755079|P1|Participant Flow|Placebo Control|"group of persons with spinal cord injury will receive blinded placebo capsule~placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function."
1026138|NCT00755079|O2|Outcome|Active Drug|"group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule~extended release beta-2 adrenergic agonist: Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles."
1026139|NCT00755079|O1|Outcome|Placebo Control|"group of persons with spinal cord injury will receive blinded placebo capsule~placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function."
1026140|NCT00755079|O2|Outcome|Active Drug|"group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule~extended release beta-2 adrenergic agonist: Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles."
1026141|NCT00755079|O1|Outcome|Placebo Control|"group of persons with spinal cord injury will receive blinded placebo capsule~placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function."
1026142|NCT00755079|E2|Reported Event|Active Drug|"group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule~extended release beta-2 adrenergic agonist: Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles."
1026143|NCT00755079|E1|Reported Event|Placebo|"group of persons with spinal cord injury will receive blinded placebo capsule~placebo: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function."
1026144|NCT00755040|B3|Baseline|Total|Total of all reporting groups
1026145|NCT00755040|B2|Baseline|Placebo|"Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.~placebo: Given as eye drops"
1026146|NCT00755040|B1|Baseline|Ocular Cyclosporine (Restasis)|"Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.~cyclosporine ophthalmic emulsion: Given as eye drops"
1026147|NCT00755040|P2|Participant Flow|Arm II|"Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.~placebo: Given as eye drops"
1026148|NCT00755040|P1|Participant Flow|Arm I|"Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.~cyclosporine ophthalmic emulsion: Given as eye drops"
1026149|NCT00755040|O2|Outcome|Arm II|"Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.~placebo: Given as eye drops"
1026150|NCT00755040|O1|Outcome|Arm I|"Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.~cyclosporine ophthalmic emulsion: Given as eye drops"
1026151|NCT00755040|O2|Outcome|Arm II|"Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.~placebo: Given as eye drops"
1026152|NCT00755040|O1|Outcome|Arm I|"Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.~cyclosporine ophthalmic emulsion: Given as eye drops"
1026153|NCT00755040|E2|Reported Event|Arm II|"Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.~placebo: Given as eye drops"
1026154|NCT00755040|E1|Reported Event|Arm I|"Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.~cyclosporine ophthalmic emulsion: Given as eye drops"
1026155|NCT00754923|B1|Baseline|Treatment: Sorafenib|"Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle.~sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient."
1026156|NCT00754923|P1|Participant Flow|Treatment: Sorafenib|"Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle.~sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient."
1026157|NCT00754923|O1|Outcome|Treatment: Sorafenib|"Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle.~sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient."
1026158|NCT00754923|O1|Outcome|Treatment: Sorafenib|"Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle.~sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient."
1026159|NCT00754923|E1|Reported Event|Treatment: Sorafenib|"Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle.~sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient."
1026160|NCT00754832|B1|Baseline|Intent to Treat Study Population|all participants who received at least one dose of either placebo or ginseng in this crossover trial
1026161|NCT00754832|P2|Participant Flow|Placebo First Then Ginseng|placebo 1 cap daily escalating to 4 caps daily for 6 weeks followed by 2 weeks washout, then ginseng 100 mg daily escalating to 400 mg daily for 6 weeks
1026162|NCT00754832|P1|Participant Flow|Ginseng First Then Placebo|ginseng 100 mg daily escalating to 400 mg daily for 6 weeks followed by 2 weeks washout, then placebo 1 cap daily escalating to 4 caps daily for 6 weeks
1026163|NCT00754832|O2|Outcome|Placebo|placebo 1 tab daily escalating to 4 tabs daily for 6 weeks
1026164|NCT00754832|O1|Outcome|Ginseng|ginseng 100 mg daily escalating to 400 mg daily for 6 weeks
1026165|NCT00754832|O2|Outcome|Placebo|placebo 1 tab daily escalating to 4 tabs daily for 6 weeks
1026166|NCT00754832|O1|Outcome|Ginseng|ginseng 100 mg daily escalating to 400 mg daily for 6 weeks
1026167|NCT00754832|O2|Outcome|Placebo|placebo 1 tab daily escalating to 4 tabs daily for 6 weeks
1026168|NCT00754832|O1|Outcome|Ginseng|ginseng 100 mg daily escalating to 400 mg daily for 6 weeks
1026169|NCT00754832|E2|Reported Event|Placebo|placebo 1 tab daily escalating to 4 tabs daily for 6 weeks
1026170|NCT00754832|E1|Reported Event|Ginseng|ginseng 100 mg daily escalating to 400 mg daily for 6 weeks
1026171|NCT00754793|B3|Baseline|Total|Total of all reporting groups
1026172|NCT00754793|B2|Baseline|Placebo|Placebo drug
1026173|NCT00754793|B1|Baseline|Active Drug (Lexapro)|escitalopram 10mg - 30mg daily
1026174|NCT00754793|P2|Participant Flow|Placebo|Placebo drug
1026175|NCT00754793|P1|Participant Flow|Active Drug (Lexapro)|escitalopram 10mg - 30mg daily
1026176|NCT00754793|O2|Outcome|Placebo|Placebo drug
1026177|NCT00754793|O1|Outcome|Active Drug (Lexapro)|escitalopram 10mg - 30mg daily
1026178|NCT00754793|E2|Reported Event|Placebo|Placebo drug
1026179|NCT00754793|E1|Reported Event|Active Drug (Lexapro)|escitalopram 10mg - 30mg daily
1026180|NCT00754767|B3|Baseline|Total|Total of all reporting groups
1026181|NCT00754767|B2|Baseline|Arm II|"Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.~placebo: Given orally"
1026182|NCT00754767|B1|Baseline|Arm I|"Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.~L-carnitine L-tartrate: Given orally"
1026183|NCT00754767|P2|Participant Flow|Arm II|"Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.~placebo: Given orally"
1026184|NCT00754767|P1|Participant Flow|Arm I|"Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.~L-carnitine L-tartrate: Given orally"
1026185|NCT00754767|O2|Outcome|Arm II|"Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.~placebo: Given orally"
1026186|NCT00754767|O1|Outcome|Arm I|"Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.~L-carnitine L-tartrate: Given orally"
1026286|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
1029078|NCT00746733|O1|Outcome|Vyvanse|
1026187|NCT00754767|E2|Reported Event|Arm II|"Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.~placebo: Given orally"
1026188|NCT00754767|E1|Reported Event|Arm I|"Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.~L-carnitine L-tartrate: Given orally"
1026189|NCT00754741|B4|Baseline|Total|Total of all reporting groups
1026190|NCT00754741|B3|Baseline|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
1026191|NCT00754741|B2|Baseline|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
1057133|NCT00675766|B2|Baseline|Group 2|HIV-positive adults 18-40 years old
1026192|NCT00754741|B1|Baseline|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
1026193|NCT00754741|P3|Participant Flow|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
1026194|NCT00754741|P2|Participant Flow|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
1026195|NCT00754741|P1|Participant Flow|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
1026196|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
1026197|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
1026198|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
1026199|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
1026200|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
1026201|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
1026202|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
1026203|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
1026204|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
1026205|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
1026206|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
1026207|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
1026287|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
1026208|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
1026209|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
1026210|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
1026231|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
1026519|NCT00754130|O4|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily
1026211|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
1026212|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
1026213|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
1026214|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
1026215|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
1026216|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
1026217|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
1026218|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
1026219|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
1026220|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
1026221|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
1026222|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
1026223|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
1026224|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
1026225|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
1026226|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
1026227|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
1026228|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
1026229|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
1026230|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
1026232|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
1026233|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
1026234|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
1026235|NCT00754741|O3|Outcome|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
1026236|NCT00754741|O2|Outcome|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
1026237|NCT00754741|O1|Outcome|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
1026238|NCT00754741|E3|Reported Event|Adherence Information Plus Motivational Interviewing|Adherence information plus motivational interviewing: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
1026239|NCT00754741|E2|Reported Event|Adherence Information|Adherence information: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
1026240|NCT00754741|E1|Reported Event|Usual Care|All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
1026241|NCT00754650|B1|Baseline|Bevacizumab 15 mg/kg|Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
1026242|NCT00754650|P1|Participant Flow|Bevacizumab 15 mg/kg|Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
1026243|NCT00754650|O1|Outcome|Bevacizumab 15 mg/kg|Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
1026244|NCT00754650|O1|Outcome|Bevacizumab 15 mg/kg|Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
1026245|NCT00754650|E1|Reported Event|Bevacizumab 15 mg/kg|Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
1026246|NCT00754624|B1|Baseline|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
1026247|NCT00754624|P1|Participant Flow|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
1026248|NCT00754624|O1|Outcome|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
1026249|NCT00754624|O1|Outcome|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
1026250|NCT00754624|O1|Outcome|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
1026251|NCT00754624|O1|Outcome|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
1026252|NCT00754624|O1|Outcome|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
1026253|NCT00754624|O1|Outcome|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
1026254|NCT00754624|O1|Outcome|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
1026255|NCT00754624|E1|Reported Event|TI Inhalation Powder|Technosphere® Insulin Inhalation Powder
1026256|NCT00754572|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
1026257|NCT00754572|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenously (iv), once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throuhgout the study.
1026375|NCT00754468|O2|Outcome|Group 2: Cryo Spray Ablation|Cryo Spray Ablation: Cryo Spray Ablation 2 cycles x 20 seconds
1026258|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
1026259|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
1026260|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
1026261|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
1026262|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
1026263|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
1026264|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
1026265|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
1026266|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
1026267|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
1026268|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
1026269|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
1026270|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
1026271|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
1026272|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
1026273|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
1026274|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
1026275|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
1026276|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
1026277|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
1026278|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
1026279|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
1026280|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
1026281|NCT00754572|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
1026282|NCT00754572|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg iv, once every 4 weeks for a total of 6 infusions along with methotrexate 10-25 mg weekly, orally or parenterally. The dose of methotrexate should have remained stable throughout the study.
1026283|NCT00754559|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
1026284|NCT00754559|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams/kilogram (mg/kg) intravenously (iv) every 4 weeks for a total of 6 infusions.
1029079|NCT00746733|E4|Reported Event|Adderall XR + Prilosec OTC|
1026288|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
1026289|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
1026290|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
1026291|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
1026292|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
1026293|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
1026294|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
1026295|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
1026296|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
1026297|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
1026298|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
1026299|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
1026300|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks up to week 20 for a total of 6 infusions.
1026301|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
1026302|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
1026303|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
1026304|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
1026305|NCT00754559|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
1026306|NCT00754559|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg iv every 4 weeks for a total of 6 infusions.
1026307|NCT00754546|B1|Baseline|All Participants|"All 20 participants were randomized to receive all 4 of the interventions in a randomzied sequence. The 4 interventions follow:~Treadmill exercise-Arformoterol Treadmill exercise-Normal Saline Cycle exercise-Arformoterol Cycle exercise-Normal Saline"
1026308|NCT00754546|P1|Participant Flow|All Participants|"All 20 participants were randomized to receive all 4 of the interventions in a randomzied sequence. The 4 interventions follow:~Treadmill exercise-Arformoterol Treadmill exercise-Normal Saline Cycle exercise-Arformoterol Cycle exercise-Normal Saline"
1026309|NCT00754546|O4|Outcome|Cycle Exercise With the Placebo Comparator|
1026310|NCT00754546|O3|Outcome|Treadmill Exercise With the Placebo Comparator|
1026311|NCT00754546|O2|Outcome|Cycle Exercise With the Active Comparator|
1026312|NCT00754546|O1|Outcome|Treadmill Exercise With the Active Comparator|
1026313|NCT00754546|O4|Outcome|Cycle Exercise With the Placebo Comparator|
1026314|NCT00754546|O3|Outcome|Treadmill Exercise With the Placebo Comparator|
1026315|NCT00754546|O2|Outcome|Cycle Exercise With the Active Comparator|
1026316|NCT00754546|O1|Outcome|Treadmill Exercise With the Active Comparator|
1026317|NCT00754546|E4|Reported Event|Cycle Exercise With the Placebo Comparator|
1026318|NCT00754546|E3|Reported Event|Treadmill Exercise With the Placebo Comparator|
1026319|NCT00754546|E2|Reported Event|Cycle Exercise With the Active Comparator|
1026320|NCT00754546|E1|Reported Event|Treadmill Exercise With the Active Comparator|
1026321|NCT00754494|B4|Baseline|Total|Total of all reporting groups
1026322|NCT00754494|B3|Baseline|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
1026323|NCT00754494|B2|Baseline|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
1026324|NCT00754494|B1|Baseline|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
1026325|NCT00754494|P3|Participant Flow|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
1026326|NCT00754494|P2|Participant Flow|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
1026327|NCT00754494|P1|Participant Flow|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
1026328|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
1026329|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
1026330|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
1026331|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
1026332|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
1026333|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
1026334|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
1026335|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
1026520|NCT00754130|O3|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
1057134|NCT00675766|B1|Baseline|Group 1|HIV-positive adults 50 and older
1026336|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
1026337|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
1026338|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
1026339|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
1026340|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
1026341|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
1026342|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
1026343|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
1026344|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
1026345|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
1026346|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
1026347|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
1026348|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
1026349|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
1026350|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
1026351|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
1026352|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
1026353|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
1026354|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
1026355|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
1026356|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
1026357|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
1026358|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
1026359|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
1026360|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
1026361|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
1026362|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
1026363|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
1026364|NCT00754494|O3|Outcome|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 7 to 23 days"
1026365|NCT00754494|O2|Outcome|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 8 to 28 days"
1026366|NCT00754494|O1|Outcome|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies~The range of days on treatment is 10 to 29 days"
1026367|NCT00754494|E3|Reported Event|Arm III (100 mg)|"Patients receive 100 mg of erlotinib hydrochloride PO and two 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
1026368|NCT00754494|E2|Reported Event|Arm II (50 mg)|"Patients receive 50 mg of erlotinib hydrochloride PO and one 100 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
1026369|NCT00754494|E1|Reported Event|Arm I (25 mg)|"Patients receive 25mg of erlotinib hydrochloride PO and one 100 mg of placebo and one 25 mg of placebo PO QD.~erlotinib hydrochloride: Given PO~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
1026370|NCT00754468|B3|Baseline|Total|Total of all reporting groups
1026371|NCT00754468|B2|Baseline|Group 2|"Subjects in Group 2 will receive a cryospray applied to healthy tissue for 20 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated two (2) times in sequential fashion for a total of 40 seconds of cryospray therapy.~CryoSpray Ablation(TM): CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications. (K070893) As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold."
1026372|NCT00754468|B1|Baseline|Group 1|"Subjects in Group 1 will receive a cryospray applied to healthy tissue for 10 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated four (4) times in sequential fashion for a total of 40 seconds of cryospray therapy.~CryoSpray Ablation(TM): CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications. (K070893) As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold."
1026373|NCT00754468|P2|Participant Flow|Group 2|"Subjects in Group 2 will receive a cryospray applied to healthy tissue for 20 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated two (2) times in sequential fashion for a total of 40 seconds of cryospray therapy.~CryoSpray Ablation(TM): CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications. (K070893) As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold."
1026374|NCT00754468|P1|Participant Flow|Group 1|"Subjects in Group 1 will receive a cryospray applied to healthy tissue for 10 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated four (4) times in sequential fashion for a total of 40 seconds of cryospray therapy.~CryoSpray Ablation(TM): CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications. (K070893) As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold."
1026376|NCT00754468|O1|Outcome|Group 1: Cryo Spray Ablation|Cryo Spray Ablation: Cryo Spray Ablation 4 cycles x 10 seconds treatment
1026377|NCT00754468|O2|Outcome|Group 2: Cryo Spray Ablation|"cryo spray ablation applied to healthy tissue 2 cycles x20 seconds~Cryo Spray Ablation: Cryo Spray Ablation 2 cycles x 20 seconds"
1026378|NCT00754468|O1|Outcome|Group 1: Cryo Spray Ablation|"cryo spray ablation applied to healthy tissue 4 cycles x 10 seconds~Cryo Spray Ablation: Cryo Spray Ablation 4 cycles x 10 seconds treatment"
1026414|NCT00754338|P4|Participant Flow|Ph2: 1st-ReNu Multiplus(Rub), 2nd RepleniSH(No-rub)&Supraclens|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' first, and Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.
1026521|NCT00754130|O2|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
1060260|NCT00666965|O1|Outcome|Placebo|placebo transdermal patch
1026379|NCT00754468|E2|Reported Event|Group 2|"Subjects in Group 2 will receive a cryospray applied to healthy tissue for 20 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated two (2) times in sequential fashion for a total of 40 seconds of cryospray therapy.~CryoSpray Ablation(TM): CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications. (K070893) As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold."
1026380|NCT00754468|E1|Reported Event|Group 1|"Subjects in Group 1 will receive a cryospray applied to healthy tissue for 10 seconds, as measured by the device integrated timer beginning at the point when a sustained cryofrost appears. The cryospray will be repeated four (4) times in sequential fashion for a total of 40 seconds of cryospray therapy.~CryoSpray Ablation(TM): CSA Medical, Inc. (formerly CryMed Technologies, Inc.) received FDA market clearance for the CSA System (CryoSpray AblationTM System, formally Cryo Ablator System) on April 21, 2006. It is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications. (K070893) As defined by the FDA, the CSA System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories used to destroy tissue during surgical procedures by applying extreme cold."
1026381|NCT00754442|B3|Baseline|Total|Total of all reporting groups
1026382|NCT00754442|B2|Baseline|Patient Group|patients with secondary hyperparathyroidism
1026383|NCT00754442|B1|Baseline|Controls|controls with normal PTH
1026384|NCT00754442|P2|Participant Flow|Patient Group|patients with secondary hyperparathyroidism
1026385|NCT00754442|P1|Participant Flow|Controls|controls with normal PTH
1026386|NCT00754442|O1|Outcome|Patients|patients with idiopathic secondary hyperparathyroidism
1026387|NCT00754442|O2|Outcome|Controls|Controls without secondary hyperparathyroidism
1026388|NCT00754442|O1|Outcome|Group 1|"patients with secondary hyperparathyroidism"
1026389|NCT00754442|E2|Reported Event|Patient Group|patients with secondary hyperparathyroidism
1026390|NCT00754442|E1|Reported Event|Controls|controls with normal PTH
1026391|NCT00754390|B1|Baseline|Entire Study Population|Includes all subjects randomized to the 4 treatments. Treatments were assigned in randomized order so the number of subjects starting the study does not equal the starting number for a given treatment
1026392|NCT00754390|P1|Participant Flow|Calcium and Phytate Interactions|Subjects consumed 4 test meals (Moderate Calcium (Ca),Low Phytate; Moderate Ca,High Phytate; High Ca,Low Phytate; High Ca,High Phytate) in random order
1026393|NCT00754390|O4|Outcome|High Calcium, High Phytate Diet|Two days of radiolabelled diet containing 1900 milligrams of Calcium per day and 1800 milligrams of phytate per day
1026394|NCT00754390|O3|Outcome|High Calcium, Low Phytate Diet|Two days of radiolabelled diet containing 1900 milligrams of Calcium per day and 440 milligrams of phytate per day
1026395|NCT00754390|O2|Outcome|Moderate Calcium, High Phytate Diet|Two days of radiolabelled diet containing 700 milligrams of Calcium per day and 1800 milligrams of phytate per day
1026396|NCT00754390|O1|Outcome|Moderate Calcium, Low Phytate Diet|Two days of radiolabelled diet containing 700 milligrams of Calcium per day and 440 milligrams of phytate per day
1026397|NCT00754390|E1|Reported Event|Overall Study|Participants consumed 4 dietary treatments in randomized order
1026398|NCT00754377|B3|Baseline|Total|Total of all reporting groups
1026399|NCT00754377|B2|Baseline|Comparison Group|Didn't receive intervention
1026400|NCT00754377|B1|Baseline|PBLI Curriculum Group|Received PBLI curriculum to evaluate and develop tools.
1026401|NCT00754377|P2|Participant Flow|Comparison Group|Alternate rotations and didn't receive intervention
1026402|NCT00754377|P1|Participant Flow|PBL Curriculum Group|"To evaluate preliminary data on a PBLI curriculum grounded on QI system projects.~PBLI curriculum comparison: The design is a pre-post comparison of PBLI curriculum participants versus non-participants. Data will come from the closed-ended items on the questionnaire given before the rotation and at the end of the rotation. PBLI curriculum was offered on alternate rotations (residents on alternate month were involved with a different curriculum). Preliminary data is available from 11 blocks, 6 PBLI QI Systems Curriculum blocks (n=50) and 5 comparison blocks (n=42) during the previous academic year. Closed-ended items assessed beliefs about different aspects of Continuous Quality Improvement (CQI) project development and implementation (6 items). In addition, there were 5 short definition items to address knowledge. Finally, content analysis methods will be used to evaluate responses to the open-ended item which asked respondents to develop a project to improve patient care."
1026403|NCT00754377|O2|Outcome|Comparison Group|Didn't receive the intervention.
1026404|NCT00754377|O1|Outcome|PBLI Curriclum Group|Received the intervention and evaluate and develop PBLI tools
1026405|NCT00754377|O2|Outcome|Comparison Group|Didn't receive intervention
1026406|NCT00754377|O1|Outcome|PBLI Curriculum Group|Received the intervention and used to evaluate and develop PBLI tools
1026407|NCT00754377|E2|Reported Event|Comparison Group|Didn't receive the intervention
1026408|NCT00754377|E1|Reported Event|PBLI Curriculum Group|Received the intervention. To evaluate and develop PBLI tools.
1026409|NCT00754338|B5|Baseline|Total|Total of all reporting groups
1026410|NCT00754338|B4|Baseline|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
1026411|NCT00754338|B3|Baseline|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
1027167|NCT00753337|E1|Reported Event|Assurant Cobalt Iliac Stent|Treatment with Iliac stenting system
1026412|NCT00754338|B2|Baseline|Ph1: RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
1026413|NCT00754338|B1|Baseline|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
1026516|NCT00754130|O3|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
1026415|NCT00754338|P3|Participant Flow|Ph2: 1st-RepleniSH(No-rub)&Supraclens, 2nd ReNUMultiplus(Rub)|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) first, and B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.
1026416|NCT00754338|P2|Participant Flow|Ph1: 1st-RepleniSH(Rub), 2nd-RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' first, and Alcon RepleniSH™ with 'no lens rub' and Supraclens® (Daily protein remover) second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.
1026417|NCT00754338|P1|Participant Flow|Ph1: 1st-RepleniSH(No-rub) & Supraclens, 2nd RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) first, and Alcon RepleniSH™ 'with lens rub' second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.
1026418|NCT00754338|O4|Outcome|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
1026419|NCT00754338|O3|Outcome|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
1026420|NCT00754338|O2|Outcome|Ph1: RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
1026421|NCT00754338|O1|Outcome|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
1026422|NCT00754338|O4|Outcome|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
1026423|NCT00754338|O3|Outcome|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
1026424|NCT00754338|O2|Outcome|Ph1: RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
1026425|NCT00754338|O1|Outcome|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
1026426|NCT00754338|O4|Outcome|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
1026427|NCT00754338|O3|Outcome|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
1026428|NCT00754338|O2|Outcome|Ph1: RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
1026429|NCT00754338|O1|Outcome|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
1026430|NCT00754338|O4|Outcome|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
1026431|NCT00754338|O3|Outcome|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
1026432|NCT00754338|O2|Outcome|Ph1: RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
1026433|NCT00754338|O1|Outcome|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
1026434|NCT00754338|O4|Outcome|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
1026435|NCT00754338|O3|Outcome|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
1026436|NCT00754338|O2|Outcome|Ph1: RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
1026437|NCT00754338|O1|Outcome|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
1026438|NCT00754338|O4|Outcome|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
1026439|NCT00754338|O3|Outcome|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
1026440|NCT00754338|O2|Outcome|Ph1: RepleniSH(Rub)|Phase 1 - Comfort data for Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group
1026441|NCT00754338|O1|Outcome|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Comfort data for Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
1026442|NCT00754338|E4|Reported Event|Ph2: ReNu Multiplus(Rub)|Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
1026443|NCT00754338|E3|Reported Event|Ph2: RepleniSH(No-rub) & Supraclens|Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
1026444|NCT00754338|E2|Reported Event|Ph1: RepleniSH(Rub)|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
1026445|NCT00754338|E1|Reported Event|Ph1: RepleniSH(No-rub) & Supraclens|Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
1026446|NCT00754325|B3|Baseline|Total|Total of all reporting groups
1026447|NCT00754325|B2|Baseline|Fulvestrant|"Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
1026517|NCT00754130|O2|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
1026448|NCT00754325|B1|Baseline|Fulvestrant and Dasatinib|"Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
1026449|NCT00754325|P2|Participant Flow|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
1026450|NCT00754325|P1|Participant Flow|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
1026451|NCT00754325|O2|Outcome|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
1026452|NCT00754325|O1|Outcome|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
1026453|NCT00754325|O2|Outcome|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
1026454|NCT00754325|O1|Outcome|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
1026455|NCT00754325|O2|Outcome|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
1026456|NCT00754325|O1|Outcome|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
1026457|NCT00754325|O2|Outcome|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
1026458|NCT00754325|O1|Outcome|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
1026459|NCT00754325|O2|Outcome|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
1026460|NCT00754325|O1|Outcome|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
1026461|NCT00754325|O2|Outcome|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
1026462|NCT00754325|O1|Outcome|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
1026463|NCT00754325|O2|Outcome|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
1026464|NCT00754325|O1|Outcome|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
1027168|NCT00753298|B3|Baseline|Total|Total of all reporting groups
1026465|NCT00754325|E3|Reported Event|Fulvestrant Crossover to Fulvestrant and Dasatinib|"Arm 2b: Participants in this group started on the Fulvestrant only arm and later started receiving a drug regimen that consisted of both fulvestrant and dasatinib. These participants are all inclusive and not limited to Fulvestrant or Fulvestrant and Dasatinib treatment only. The timeframe for when these events occurred were not immediately available and may have been caused by previous exposure to Fulvestrant only (pre-crossover), therefore the events for this patient population are also reported separately.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
1026466|NCT00754325|E2|Reported Event|Fulvestrant|"Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years."
1026467|NCT00754325|E1|Reported Event|Fulvestrant and Dasatinib|"Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years"
1026468|NCT00754234|B1|Baseline|MyPyramid Menus|USDA MyPyramid menus for Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
1026469|NCT00754234|P1|Participant Flow|MyPyramid Menus|USDA MyPyramid menus for Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
1026470|NCT00754234|O1|Outcome|MyPyramid Menu|USDA MyPyramid menus for Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
1026471|NCT00754234|E1|Reported Event|MyPyramid Menus|USDA MyPyramid menus for Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
1026472|NCT00754156|B3|Baseline|Total|Total of all reporting groups
1026473|NCT00754156|B2|Baseline|V.A.C. or ABThera|V.A.C. or ABThera Therapy alone
1026474|NCT00754156|B1|Baseline|1 ABRA Plus V.A.C or ABThera|ABRA Abdominal Wound Closure System in combination with V.A.C. or AbThera Therapy
1026475|NCT00754156|P2|Participant Flow|2 V.A.C. or ABThera Alone|ABThera V.A.C. Therapy alone
1026476|NCT00754156|P1|Participant Flow|1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera|ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy
1026477|NCT00754156|O2|Outcome|2 V.A.C. or ABThera Alone|ABThera V.A.C. Therapy alone
1026478|NCT00754156|O1|Outcome|1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera|ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy
1026479|NCT00754156|O2|Outcome|2 V.A.C. or ABThera Alone|ABThera V.A.C. Therapy alone
1026480|NCT00754156|O1|Outcome|1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera|ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy
1026481|NCT00754156|O2|Outcome|2 V.A.C. or ABThera Alone|ABThera V.A.C. Therapy alone
1026482|NCT00754156|O1|Outcome|1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera|ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy
1026483|NCT00754156|O2|Outcome|2 V.A.C. or ABThera Alone|ABThera V.A.C. Therapy alone
1026484|NCT00754156|O1|Outcome|1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera|ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy
1026485|NCT00754156|O2|Outcome|2 V.A.C. or ABThera Alone|V.A.C. or ABThera V.A.C. Therapy alone
1026486|NCT00754156|O1|Outcome|1 ABRA Plus V.A.C. or ABThera|ABRA Abdominal Wound Closure System in combination with V.A.C. or ABThera V.A.C. Therapy
1026487|NCT00754156|O2|Outcome|2 ABThera|V.A.C. or ABThera V.A.C. Therapy alone
1026488|NCT00754156|O1|Outcome|1 ABRA Plus ABThera|ABRA Abdominal Wound Closure System in combination with V.A.C or ABThera V.A.C. Therapy
1026489|NCT00754156|O2|Outcome|2 ABThera|ABThera V.A.C. Therapy alone
1026490|NCT00754156|O1|Outcome|1 ABRA Plus ABThera|ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy
1026491|NCT00754156|E2|Reported Event|2 V.A.C. or ABThera Alone|ABThera V.A.C. Therapy alone
1026492|NCT00754156|E1|Reported Event|1 ABRA Plus KCI Abdominal Wound Vac (V.A.C.) or KCI ABThera|ABRA Abdominal Wound Closure System in combination with ABThera V.A.C. Therapy
1026493|NCT00754130|B7|Baseline|Total|Total of all reporting groups
1026494|NCT00754130|B6|Baseline|MK-0941 10mg/MK-0941 40mg|Participants received MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2
1026495|NCT00754130|B5|Baseline|MK-0941 10mg/Placebo|Participants received MK-0941 10 mg during Period 1 and Placebo during Period 2
1026496|NCT00754130|B4|Baseline|Placebo/MK-0941 40mg|Participants received Placebo during Period 1 and MK-0941 40 mg during Period 2
1026497|NCT00754130|B3|Baseline|MK-0941 5mg/MK-0941 20mg|Participants received MK-0941 5 mg during Period 1 and MK-0941 20 mg during Period 2
1026498|NCT00754130|B2|Baseline|MK-0941 5mg/Placebo|Participants received MK-0941 5 mg during Period 1 and Placebo during Period 2
1026499|NCT00754130|B1|Baseline|Placebo/MK-0941 20mg|Participants received Placebo during Period 1 and MK-0941 20 mg during Period 2
1026500|NCT00754130|P6|Participant Flow|MK-0941 10mg/MK-0941 40mg|Participants received MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2
1026501|NCT00754130|P5|Participant Flow|MK-0941 10mg/Placebo|Participants received MK-0941 10 mg during Period 1 and Placebo during Period 2
1026502|NCT00754130|P4|Participant Flow|Placebo/MK-0941 40mg|Participants received Placebo during Period 1 and MK-0941 40 mg during Period 2
1026503|NCT00754130|P3|Participant Flow|MK-0941 5mg/MK-0941 20mg|Participants received MK-0941 5 mg during Period 1 and MK-0941 20 mg during Period 2
1026504|NCT00754130|P2|Participant Flow|MK-0941 5mg/Placebo|Participants received MK-0941 5 mg during Period 1 and Placebo during Period 2
1026505|NCT00754130|P1|Participant Flow|Placebo/MK-0941 20mg|Participants received Placebo during Period 1 and MK-0941 20 mg during Period 2
1026506|NCT00754130|O4|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily
1026507|NCT00754130|O3|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
1026508|NCT00754130|O2|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
1026509|NCT00754130|O1|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
1026510|NCT00754130|O5|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily. One participant randomized to receive MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2 received MK-0941 10 mg during both Periods 1 and 2.
1026511|NCT00754130|O4|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
1026512|NCT00754130|O3|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
1026513|NCT00754130|O2|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
1026514|NCT00754130|O1|Outcome|Placebo|Participants receiving Placebo doses three times daily
1026515|NCT00754130|O4|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily
1026522|NCT00754130|O1|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
1026523|NCT00754130|O4|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily
1026524|NCT00754130|O3|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
1026525|NCT00754130|O2|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
1026526|NCT00754130|O1|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
1026527|NCT00754130|O4|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily
1026528|NCT00754130|O3|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
1026529|NCT00754130|O2|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
1026530|NCT00754130|O1|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
1026531|NCT00754130|O4|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily
1026532|NCT00754130|O3|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
1026533|NCT00754130|O2|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
1026534|NCT00754130|O1|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
1026535|NCT00754130|O5|Outcome|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily. One participant randomized to receive MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2 received MK-0941 10 mg during both Periods 1 and 2.
1026536|NCT00754130|O4|Outcome|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
1026537|NCT00754130|O3|Outcome|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
1026538|NCT00754130|O2|Outcome|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
1026539|NCT00754130|O1|Outcome|Placebo|Participants receiving Placebo doses three times daily
1026540|NCT00754130|E5|Reported Event|MK-0941 40mg|Participants receiving MK-0941 40 mg doses three times daily. One participant randomized to receive MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2 received MK-0941 10 mg during both Periods 1 and 2.
1026541|NCT00754130|E4|Reported Event|MK-0941 20mg|Participants receiving MK-0941 20 mg doses three times daily
1026542|NCT00754130|E3|Reported Event|MK-0941 10mg|Participants receiving MK-0941 10 mg doses three times daily
1026543|NCT00754130|E2|Reported Event|MK-0941 5mg|Participants receiving MK-0941 5 mg doses three times daily
1026544|NCT00754130|E1|Reported Event|Placebo|Participants receiving Placebo doses three times daily
1026545|NCT00754065|B3|Baseline|Total|Total of all reporting groups
1026546|NCT00754065|B2|Baseline|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026547|NCT00754065|B1|Baseline|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026548|NCT00754065|P2|Participant Flow|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026549|NCT00754065|P1|Participant Flow|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026550|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026551|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026552|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026553|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026802|NCT00753948|P2|Participant Flow|Mild Asthma|"Individuals with diagnosed mild asthma~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
1026554|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026555|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026556|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026557|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026558|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1027039|NCT00753519|O2|Outcome|On Medication Sham iTBS|Subjects ON medication while receiving SHAM iTBS
1026559|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026560|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026561|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026562|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026563|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026564|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026565|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026566|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026567|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026568|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026569|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026570|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026571|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026572|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026573|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026574|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026575|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026576|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026577|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1027169|NCT00753298|B2|Baseline|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
1026578|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026579|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026580|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026581|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026582|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026583|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026584|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026585|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026586|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026587|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026588|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026589|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026590|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026591|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026592|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026593|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026594|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026595|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026596|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026597|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026598|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026599|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026600|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026601|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1027170|NCT00753298|B1|Baseline|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
1026602|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026603|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026604|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026605|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026606|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026607|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026608|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026609|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026610|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026611|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026612|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026613|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026614|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026615|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026616|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026617|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026618|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026619|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026620|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026621|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026622|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026623|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026624|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026625|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1027171|NCT00753298|P2|Participant Flow|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
1026626|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026627|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026628|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026629|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026630|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026631|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026632|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026633|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026634|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026635|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026636|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026637|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026638|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026639|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026640|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026641|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026642|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026643|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026644|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026645|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026646|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026647|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026648|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026649|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1027172|NCT00753298|P1|Participant Flow|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
1026650|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026651|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026652|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026653|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026654|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026655|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026656|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026657|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026658|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026659|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026660|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026661|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026662|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026663|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026664|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026665|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026666|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026667|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026668|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026669|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026670|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026671|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026672|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026673|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1027173|NCT00753298|O2|Outcome|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
1026674|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026675|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026676|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026677|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026678|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026679|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026680|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026681|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026682|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026683|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026684|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026685|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026686|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026687|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026688|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026689|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026690|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026691|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026692|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026693|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026694|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026695|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026696|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026697|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1027174|NCT00753298|O1|Outcome|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
1026698|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026699|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026700|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026701|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026702|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026703|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026704|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026705|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026706|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026707|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026708|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026709|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026710|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026711|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026712|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026713|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026714|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026715|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026716|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026717|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026718|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026719|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026720|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026721|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1027175|NCT00753298|O2|Outcome|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
1026722|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026723|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026724|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026725|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026726|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026727|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026728|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026729|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026730|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026731|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026732|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026733|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026734|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026735|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026736|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026737|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026738|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026739|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026740|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026741|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026742|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026743|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026744|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026745|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1027176|NCT00753298|O1|Outcome|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
1026746|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026747|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026748|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026749|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026750|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026751|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026752|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026753|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026754|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026755|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026756|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026757|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026758|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026759|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026760|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026761|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026762|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026763|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026764|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026765|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026766|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026767|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026768|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026769|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1027177|NCT00753298|O2|Outcome|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
1026770|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026771|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026772|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026773|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026774|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026775|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026776|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026777|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026778|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026779|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026780|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026781|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026782|NCT00754065|O2|Outcome|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026783|NCT00754065|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026784|NCT00754065|E2|Reported Event|Ortho Tri-Cyclen Lo|Daily oral administration of one capsule Ortho Tri-Cyclen Lo [Ethinylestradiol (EE)/ Norgestimate (NGM)] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
1026785|NCT00754065|E1|Reported Event|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles(treatment encapsulated)
1026786|NCT00754013|B3|Baseline|Total|Total of all reporting groups
1026787|NCT00754013|B2|Baseline|Placebo|Donepezil matched placebo was titrated in the similar way as the donepezil arm.
1026788|NCT00754013|B1|Baseline|Donepezil|Donepezil was titrated to a dose of approximately 0.1-0.2 mg/kg/day as liquid containing 1 mg/1 mL of donepezil.
1026789|NCT00754013|P2|Participant Flow|Placebo|Donepezil matched placebo was titrated in the similar way as the donepezil arm.
1026790|NCT00754013|P1|Participant Flow|Donepezil|Donepezil was titrated to a dose of approximately 0.1-0.2 mg/kg/day as liquid containing 1 mg/1 mL of donepezil.
1026791|NCT00754013|O2|Outcome|Placebo|Donepezil matched placebo was titrated in the similar way as the donepezil arm.
1026792|NCT00754013|O1|Outcome|Donepezil|Donepezil was titrated to a dose of approximately 0.1-0.2 mg/kg/day as liquid containing 1 mg/1 mL of donepezil.
1026793|NCT00754013|O2|Outcome|Placebo|Donepezil matched placebo was titrated in the similar way as the donepezil arm.
1026794|NCT00754013|O1|Outcome|Donepezil|Donepezil was titrated to a dose of approximately 0.1-0.2 mg/kg/day as liquid containing 1 mg/1 mL of donepezil.
1026795|NCT00754013|E2|Reported Event|Placebo|Donepezil matched placebo was titrated in the similar way as the donepezil arm.
1026796|NCT00754013|E1|Reported Event|Donepezil|Donepezil was titrated to a dose of approximately 0.1-0.2 mg/kg/day as liquid containing 1 mg/1 mL of donepezil.
1026797|NCT00753948|B4|Baseline|Total|Total of all reporting groups
1026798|NCT00753948|B3|Baseline|Healthy Controls|"Neurologically intact, otherwise healthy, age-matched control~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
1026799|NCT00753948|B2|Baseline|Mild Asthma|"Individuals with diagnosed mild asthma~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
1026800|NCT00753948|B1|Baseline|Chronic Tetraplegia|"Individuals with chronic tetraplegia~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
1026801|NCT00753948|P3|Participant Flow|Healthy Control|"Neurologically intact, otherwise healthy, age-matched control~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
1026803|NCT00753948|P1|Participant Flow|Chronic Tetraplegia|"Individuals with chronic tetraplegia~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
1026804|NCT00753948|O3|Outcome|Arm 3|"Neurologically intact, otherwise healthy, age-matched control~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
1026805|NCT00753948|O2|Outcome|Arm 2|"Individuals with diagnosed mild asthma~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
1026806|NCT00753948|O1|Outcome|Arm 1|"Individuals with chronic tetraplegia~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
1026807|NCT00753948|E3|Reported Event|Arm 3|"Neurologically intact, otherwise healthy, age-matched control~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
1026808|NCT00753948|E2|Reported Event|Arm 2|"Individuals with diagnosed mild asthma~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
1026809|NCT00753948|E1|Reported Event|Arm 1|"Individuals with chronic tetraplegia~N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme."
1026810|NCT00753922|B5|Baseline|Total|Total of all reporting groups
1026811|NCT00753922|B4|Baseline|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
1026812|NCT00753922|B3|Baseline|Revision Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
1026813|NCT00753922|B2|Baseline|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.~Asymmetry is one or more of the following conditions:~One cup size difference in breast size.~The need to differentially pad one bra cup to match the opposite breast size.~Asymmetry due to chest wall deformity such as scoliosis or other deformities of the thoracic cage and/or associated visible differences in shoulder height that can make one breast appear to be at a different height than the other."
1026814|NCT00753922|B1|Baseline|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
1026815|NCT00753922|P4|Participant Flow|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
1026816|NCT00753922|P3|Participant Flow|Revision Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
1026817|NCT00753922|P2|Participant Flow|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.~Asymmetry is one or more of the following conditions:~One cup size difference in breast size.~The need to differentially pad one bra cup to match the opposite breast size.~Asymmetry due to chest wall deformity such as scoliosis or other deformities of the thoracic cage and/or associated visible differences in shoulder height that can make one breast appear to be at a different height than the other."
1026818|NCT00753922|P1|Participant Flow|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
1026819|NCT00753922|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
1026820|NCT00753922|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
1026821|NCT00753922|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
1026822|NCT00753922|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
1026823|NCT00753922|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
1026824|NCT00753922|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
1026825|NCT00753922|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
1026826|NCT00753922|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
1026827|NCT00753922|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
1026828|NCT00753922|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
1026829|NCT00753922|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
1026830|NCT00753922|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
1026831|NCT00753922|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
1026832|NCT00753922|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
1026833|NCT00753922|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
1026834|NCT00753922|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
1026835|NCT00753922|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
1026836|NCT00753922|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
1026837|NCT00753922|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
1026838|NCT00753922|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
1026839|NCT00753922|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
1026840|NCT00753922|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
1026841|NCT00753922|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
1026842|NCT00753922|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
1026843|NCT00753922|E4|Reported Event|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
1026844|NCT00753922|E3|Reported Event|Revison Augmentation|Patients in this cohort will have had previous breast augmentation or reconstruction with silicone or saline filled implants.
1026845|NCT00753922|E2|Reported Event|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry.~Asymmetry is one or more of the following conditions:~One cup size difference in breast size.~The need to differentially pad one bra cup to match the opposite breast size.~Asymmetry due to chest wall deformity such as scoliosis or other deformities of the thoracic cage and/or associated visible differences in shoulder height that can make one breast appear to be at a different height than the other."
1026846|NCT00753922|E1|Reported Event|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
1026847|NCT00753896|B1|Baseline|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
1026848|NCT00753896|P1|Participant Flow|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
1026849|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
1026850|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
1026851|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
1026852|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
1026853|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
1026854|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
1026855|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
1026856|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
1026857|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
1026858|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
1026859|NCT00753896|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
1026860|NCT00753896|E1|Reported Event|Exenatide Once Weekly|Subcutaneous injection, 2.0mcg, once weekly.
1026861|NCT00753766|B3|Baseline|Total|Total of all reporting groups
1026862|NCT00753766|B2|Baseline|Control|Control group
1026863|NCT00753766|B1|Baseline|Intervention|"Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.~Multifactorial Intervention: Intervention included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise."
1026864|NCT00753766|P2|Participant Flow|Usual Care|Control group
1026865|NCT00753766|P1|Participant Flow|Multifactorial Intervention|Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.
1026866|NCT00753766|O2|Outcome|Usual Care|Control group
1026867|NCT00753766|O1|Outcome|Multifactorial Intervention|Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.
1026868|NCT00753766|O2|Outcome|Usual Care|Control group
1026869|NCT00753766|O1|Outcome|Multifactorial Intervention|Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.
1026870|NCT00753766|E2|Reported Event|Usual Care|Control group
1026871|NCT00753766|E1|Reported Event|Multifactorial Intervention|Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.
1026872|NCT00753714|B3|Baseline|Total|Total of all reporting groups
1026873|NCT00753714|B2|Baseline|Placebo to Match ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
1026874|NCT00753714|B1|Baseline|ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
1060262|NCT00666965|O3|Outcome|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
1026875|NCT00753714|P2|Participant Flow|Placebo to Match ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
1026876|NCT00753714|P1|Participant Flow|ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
1026877|NCT00753714|O2|Outcome|Placebo to Match ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
1026878|NCT00753714|O1|Outcome|ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
1026879|NCT00753714|O2|Outcome|Placebo to Match ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
1026880|NCT00753714|O1|Outcome|ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
1026881|NCT00753714|O2|Outcome|Placebo to Match ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
1026882|NCT00753714|O1|Outcome|ZD6474 ( (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
1026883|NCT00753714|O2|Outcome|Placebo to Match ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
1026884|NCT00753714|O1|Outcome|ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
1026908|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
1026885|NCT00753714|O2|Outcome|Placebo to Match ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
1026886|NCT00753714|O1|Outcome|ZD6474 (Vandetanib),Gemcitabine|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1.Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
1026913|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
1026887|NCT00753714|E2|Reported Event|Placebo to Match ZD6474 (Gemcitabine), Vandetanib|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued
1026888|NCT00753714|E1|Reported Event|ZD6474 (Gemcitabine), Vandetanib|Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued.
1026889|NCT00753688|B3|Baseline|Total|Total of all reporting groups
1026890|NCT00753688|B2|Baseline|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
1026891|NCT00753688|B1|Baseline|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
1026892|NCT00753688|P2|Participant Flow|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
1026893|NCT00753688|P1|Participant Flow|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
1026894|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
1026895|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
1026896|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
1026897|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
1026898|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
1026899|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
1026900|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
1026901|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
1026902|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
1026903|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
1026904|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
1026905|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
1026906|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
1026907|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
1026909|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
1026910|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
1026911|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
1026912|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
1026914|NCT00753688|O2|Outcome|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
1026915|NCT00753688|O1|Outcome|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
1026916|NCT00753688|E2|Reported Event|Pazopanib|Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
1026917|NCT00753688|E1|Reported Event|Placebo|Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
1026918|NCT00753675|B4|Baseline|Total|Total of all reporting groups
1026919|NCT00753675|B3|Baseline|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
1026920|NCT00753675|B2|Baseline|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
1026921|NCT00753675|B1|Baseline|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
1026922|NCT00753675|P3|Participant Flow|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
1026923|NCT00753675|P2|Participant Flow|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
1026924|NCT00753675|P1|Participant Flow|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
1026925|NCT00753675|O3|Outcome|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
1026926|NCT00753675|O2|Outcome|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
1026927|NCT00753675|O1|Outcome|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
1026928|NCT00753675|O3|Outcome|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
1026929|NCT00753675|O2|Outcome|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
1026930|NCT00753675|O1|Outcome|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
1026931|NCT00753675|O3|Outcome|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
1027022|NCT00753545|E2|Reported Event|Placebo bd|Olaparib matching placebo oral capsules twice daily
1027023|NCT00753545|E1|Reported Event|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
1027024|NCT00753519|B3|Baseline|Total|Total of all reporting groups
1026932|NCT00753675|O2|Outcome|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
1026933|NCT00753675|O1|Outcome|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
1026934|NCT00753675|O3|Outcome|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
1026972|NCT00753636|O1|Outcome|Isradipine 20mg, 15mg, 10mg or 5 mg|
1026973|NCT00753636|O1|Outcome|Isradipine 20mg, 15mg, 10mg or 5 mg|
1026974|NCT00753636|O1|Outcome|Isradipine 20mg, 15mg, 10mg or 5 mg|
1026975|NCT00753636|E1|Reported Event|Isradipine 20mg, 15mg, 10mg or 5 mg|
1026935|NCT00753675|O2|Outcome|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
1026936|NCT00753675|O1|Outcome|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
1026937|NCT00753675|O3|Outcome|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
1026938|NCT00753675|O2|Outcome|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
1026939|NCT00753675|O1|Outcome|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
1026940|NCT00753675|E3|Reported Event|ARM C Placebo+ Gemcitabine|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy).
1026941|NCT00753675|E2|Reported Event|Arm B Vandetanib 100mg + Gemcitab|Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy)
1026942|NCT00753675|E1|Reported Event|Arm A Vandetanib 300 mg|Vandetanib 300 mg as a once daily oral dose, from Day 1
1026943|NCT00753649|B3|Baseline|Total|Total of all reporting groups
1026944|NCT00753649|B2|Baseline|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
1026945|NCT00753649|B1|Baseline|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
1026946|NCT00753649|P2|Participant Flow|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
1026947|NCT00753649|P1|Participant Flow|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
1026948|NCT00753649|O2|Outcome|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
1026949|NCT00753649|O1|Outcome|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
1026950|NCT00753649|O2|Outcome|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
1027025|NCT00753519|B2|Baseline|Sham iTBS|Sham iTBS
1029080|NCT00746733|E3|Reported Event|Vyvanse + Prilosec OTC|
1026951|NCT00753649|O1|Outcome|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
1026952|NCT00753649|O2|Outcome|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
1026953|NCT00753649|O1|Outcome|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
1026954|NCT00753649|O2|Outcome|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
1026955|NCT00753649|O1|Outcome|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
1026956|NCT00753649|O2|Outcome|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
1026957|NCT00753649|O1|Outcome|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
1026958|NCT00753649|O2|Outcome|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
1026959|NCT00753649|O1|Outcome|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
1026960|NCT00753649|O2|Outcome|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
1026961|NCT00753649|O1|Outcome|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
1026962|NCT00753649|O2|Outcome|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
1026963|NCT00753649|O1|Outcome|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
1026964|NCT00753649|E2|Reported Event|Infanrix Hexa Non-Aboriginal Group|Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
1027026|NCT00753519|B1|Baseline|Real iTBS|iTBS is a novel form of excitatory rTMS that may induce larger and longer lasting changes than standard rTMS. iTBS consists of bursts of 3 pulses at 50 Hz repeated at 200 msec intervals.
1026965|NCT00753649|E1|Reported Event|Infanrix Hexa Aboriginal Group|Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
1026966|NCT00753636|B1|Baseline|Isradipine 20mg, 15mg, 10mg or 5 mg|
1026967|NCT00753636|P1|Participant Flow|Isradipine 20mg, 15mg, 10mg or 5 mg|
1026968|NCT00753636|O1|Outcome|Isradipine 20mg, 15mg, 10mg or 5 mg|
1026969|NCT00753636|O1|Outcome|Isradipine 20mg, 15mg, 10mg or 5 mg|
1026970|NCT00753636|O1|Outcome|Isradipine 20mg, 15mg, 10mg or 5 mg|
1026971|NCT00753636|O1|Outcome|Isradipine 20mg, 15mg, 10mg or 5 mg|
1026977|NCT00753623|B2|Baseline|Ramelton Phase I; Placebo Phase II|"In a crossover design, a subject was first assigned to the ramelteon and then switched over to the placebo.~Ramelteon : ramelteon (8 mg)"
1026978|NCT00753623|B1|Baseline|Placebo Phase I; Ramelteon Phase II|"In a crossover design, a subject was first assigned to the placebo and then switched over to the ramelteon.~Ramelteon : ramelteon (8 mg)"
1026979|NCT00753623|P2|Participant Flow|Ramelton Phase I; Placebo Phase II|"In a crossover design, a subject was first assigned to the ramelteon and then switched over to the placebo.~Ramelteon : ramelteon (8 mg)"
1026980|NCT00753623|P1|Participant Flow|Placebo Phase I; Ramelteon Phase II|"In a crossover design, a subject was first assigned to the placebo and then switched over to the ramelteon.~Ramelteon : ramelteon (8 mg)"
1026981|NCT00753623|O2|Outcome|Placebo|Participants who received placebo medication during the first or last 2 weeks of the study.
1026982|NCT00753623|O1|Outcome|Ramelteon|Participants who received Ramelteon 8 mg during the first or last 2 weeks of the study.
1026983|NCT00753623|E2|Reported Event|Placebo|Participants who received placebo medication during the first or last 2 weeks of the study.
1026984|NCT00753623|E1|Reported Event|Ramelteon|Participants who received Ramelteon 8 mg during the first or last 2 weeks of the study.
1026985|NCT00753545|B3|Baseline|Total|Total of all reporting groups
1026986|NCT00753545|B2|Baseline|Placebo bd|Olaparib matching placebo oral capsules twice daily
1026987|NCT00753545|B1|Baseline|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
1026988|NCT00753545|P2|Participant Flow|Placebo bd|Olaparib matching placebo oral capsules twice daily
1026989|NCT00753545|P1|Participant Flow|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
1026990|NCT00753545|O2|Outcome|Placebo bd|Olaparib matching placebo oral capsules twice daily
1026991|NCT00753545|O1|Outcome|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
1026992|NCT00753545|O2|Outcome|Placebo bd|Olaparib matching placebo oral capsules twice daily
1026993|NCT00753545|O1|Outcome|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
1026994|NCT00753545|O2|Outcome|Placebo bd|Olaparib matching placebo oral capsules twice daily
1026995|NCT00753545|O1|Outcome|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
1026996|NCT00753545|O2|Outcome|Placebo bd|Olaparib matching placebo oral capsules twice daily
1026997|NCT00753545|O1|Outcome|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
1026998|NCT00753545|O2|Outcome|Placebo bd|Olaparib matching placebo oral capsules twice daily
1026999|NCT00753545|O1|Outcome|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
1027000|NCT00753545|O2|Outcome|Placebo bd|Olaparib matching placebo oral capsules twice daily
1027001|NCT00753545|O1|Outcome|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
1027002|NCT00753545|O2|Outcome|Placebo bd|Olaparib matching placebo oral capsules twice daily
1027003|NCT00753545|O1|Outcome|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
1027004|NCT00753545|O2|Outcome|Placebo bd|Olaparib matching placebo oral capsules twice daily
1027005|NCT00753545|O1|Outcome|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
1027006|NCT00753545|O2|Outcome|Placebo bd|Olaparib matching placebo oral capsules twice daily
1027007|NCT00753545|O1|Outcome|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
1027008|NCT00753545|O2|Outcome|Placebo bd|Olaparib matching placebo oral capsules twice daily
1027009|NCT00753545|O1|Outcome|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
1027010|NCT00753545|O2|Outcome|Placebo bd|Olaparib matching placebo oral capsules twice daily
1027011|NCT00753545|O1|Outcome|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
1027012|NCT00753545|O2|Outcome|Placebo bd|Olaparib matching placebo oral capsules twice daily
1027013|NCT00753545|O1|Outcome|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
1027014|NCT00753545|O2|Outcome|Placebo bd|Olaparib matching placebo oral capsules twice daily
1027015|NCT00753545|O1|Outcome|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
1027016|NCT00753545|O2|Outcome|Placebo bd|Olaparib matching placebo oral capsules twice daily
1027017|NCT00753545|O1|Outcome|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
1027018|NCT00753545|O2|Outcome|Placebo bd|Olaparib matching placebo oral capsules twice daily
1027019|NCT00753545|O1|Outcome|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
1027020|NCT00753545|O2|Outcome|Placebo bd|Olaparib matching placebo oral capsules twice daily
1027021|NCT00753545|O1|Outcome|Olaparib 400 mg bd|"AZD2281~Olaparib (AZD2281) 400 mg oral capsules twice daily"
1027027|NCT00753519|P2|Participant Flow|Sham iTBS|Sham iTBS
1027028|NCT00753519|P1|Participant Flow|Real iTBS|iTBS is a novel form of excitatory rTMS that may induce larger and longer lasting changes than standard rTMS. iTBS consists of bursts of 3 pulses at 50 Hz repeated at 200 msec intervals.
1027029|NCT00753519|O4|Outcome|Off Medication Sham iTBS|Subjects OFF medication while receiving SHAM iTBS
1027030|NCT00753519|O3|Outcome|Off Medication Real iTBS|Subjects OFF medication while receiving REAL iTBS
1027031|NCT00753519|O2|Outcome|On Medication Sham iTBS|Subjects ON medication while receiving SHAM iTBS
1027032|NCT00753519|O1|Outcome|On Medication Real iTBS|Subjects ON medication while receiving REAL iTBS
1027033|NCT00753519|O4|Outcome|Off Medication Sham iTBS|Subjects OFF medication while receiving SHAM iTBS
1027034|NCT00753519|O3|Outcome|Off Medication Real iTBS|Subjects OFF medication while receiving REAL iTBS
1027035|NCT00753519|O2|Outcome|On Medication Sham iTBS|Subjects ON medication while receiving SHAM iTBS
1027036|NCT00753519|O1|Outcome|On Medication Real iTBS|Subjects ON medication while receiving REAL iTBS
1027037|NCT00753519|O4|Outcome|Off Medication Sham iTBS|Subjects OFF medication while receiving SHAM iTBS
1027038|NCT00753519|O3|Outcome|Off Medication Real iTBS|Subjects OFF medication while receiving REAL iTBS
1027040|NCT00753519|O1|Outcome|On Medication Real iTBS|Subjects ON medication while receiving REAL iTBS
1027041|NCT00753519|O4|Outcome|Off Medication Sham iTBS|Subjects OFF medication while receiving SHAM iTBS
1027042|NCT00753519|O3|Outcome|Off Medication Real iTBS|Subjects OFF medication while receiving REAL iTBS
1027043|NCT00753519|O2|Outcome|On Medication Sham iTBS|Subjects ON medication while receiving SHAM iTBS
1027044|NCT00753519|O1|Outcome|On Medication Real iTBS|Subjects ON medication while receiving REAL iTBS
1027045|NCT00753519|E2|Reported Event|Sham iTBS|Sham iTBS
1027046|NCT00753519|E1|Reported Event|Real iTBS|iTBS is a novel form of excitatory rTMS that may induce larger and longer lasting changes than standard rTMS. iTBS consists of bursts of 3 pulses at 50 Hz repeated at 200 msec intervals.
1027047|NCT00753506|B3|Baseline|Total|Total of all reporting groups
1027048|NCT00753506|B2|Baseline|Placebo|Identical looking placebo capsule The placebo will contain an inert powder which is typically used to make many pharmaceutical tablets. The control capsules will be identical looking to the artemisinin capsules and will be prepared for use in this study by the Temple University Pharmacy which has experience in preparing materials for clinical trials.
1027049|NCT00753506|B1|Baseline|Artemisinin|Artemisinin 100 mg capsule Artemisinin (qinghaosu) is the antimalarial principle isolated by Chinese scientists from Artemisia annua L. (Sweet Wormwood plant), which has been in use in China for more than 2,000 years as an herbal tea against fever (van Agtmael et al., 1999). Artemisinin is a sesquiterpene trioxane lactone with a peroxide bridge linkage and is poorly soluble in oils or water. Johns Hopkins collaborators recently synthesized novel, nonacetal, hydrolytically stable derivatives of artemisinin and showed that they inhibit the replication of Toxoplasma gondii in cell culture (Jones-Brando et al., 2006).
1027050|NCT00753506|P2|Participant Flow|Placebo|Identical looking placebo capsule The placebo will contain an inert powder which is typically used to make many pharmaceutical tablets. The control capsules will be identical looking to the artemisinin capsules and will be prepared for use in this study by the Temple University Pharmacy which has experience in preparing materials for clinical trials.
1027051|NCT00753506|P1|Participant Flow|Artemisinin|Artemisinin 100 mg capsule Artemisinin (qinghaosu) is the antimalarial principle isolated by Chinese scientists from Artemisia annua L. (Sweet Wormwood plant), which has been in use in China for more than 2,000 years as an herbal tea against fever (van Agtmael et al., 1999). Artemisinin is a sesquiterpene trioxane lactone with a peroxide bridge linkage and is poorly soluble in oils or water. Johns Hopkins collaborators recently synthesized novel, nonacetal, hydrolytically stable derivatives of artemisinin and showed that they inhibit the replication of Toxoplasma gondii in cell culture (Jones-Brando et al., 2006).
1027052|NCT00753506|O2|Outcome|Placebo|100 mg artemisinin identical placebo capsule taken twice per day.
1027053|NCT00753506|O1|Outcome|Artemisinin|100 mg capsule of artemisinin taken twice per day.
1027054|NCT00753506|E2|Reported Event|Placebo|Identical looking placebo capsule The placebo will contain an inert powder which is typically used to make many pharmaceutical tablets. The control capsules will be identical looking to the artemisinin capsules and will be prepared for use in this study by the Temple University Pharmacy which has experience in preparing materials for clinical trials.
1027055|NCT00753506|E1|Reported Event|Artemisinin|Artemisinin 100 mg capsule Artemisinin (qinghaosu) is the antimalarial principle isolated by Chinese scientists from Artemisia annua L. (Sweet Wormwood plant), which has been in use in China for more than 2,000 years as an herbal tea against fever (van Agtmael et al., 1999). Artemisinin is a sesquiterpene trioxane lactone with a peroxide bridge linkage and is poorly soluble in oils or water. Johns Hopkins collaborators recently synthesized novel, nonacetal, hydrolytically stable derivatives of artemisinin and showed that they inhibit the replication of Toxoplasma gondii in cell culture (Jones-Brando et al., 2006).
1027056|NCT00753454|B1|Baseline|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
1027057|NCT00753454|P1|Participant Flow|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
1027058|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
1027059|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
1027060|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
1027061|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
1027062|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
1027063|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
1027064|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
1027065|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
1027066|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
1027067|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
1027068|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
1027069|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
1027070|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
1027071|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
1027072|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
1027091|NCT00753415|P10|Participant Flow|Part B: V934 HD(5)+V934 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
1029081|NCT00746733|E2|Reported Event|Adderall XR|
1027073|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
1027074|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
1027075|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
1027076|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
1027077|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
1027078|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
1027079|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
1027080|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
1027081|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
1027082|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
1027083|NCT00753454|O1|Outcome|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
1027084|NCT00753454|E1|Reported Event|CDP870|Patients having completed the Week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region (or until further notice from UCB).
1027085|NCT00753415|B6|Baseline|Total|Total of all reporting groups
1027086|NCT00753415|B5|Baseline|Part A: V934 HD(5)+V935 HD|Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
1027087|NCT00753415|B4|Baseline|Part A: V934 HD(3)+V935 HD|Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
1027088|NCT00753415|B3|Baseline|Part A: V935 HD|Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
1027089|NCT00753415|B2|Baseline|Part A: V934 LD(3)+V935 LD|Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
1027090|NCT00753415|B1|Baseline|Part A: V935 LD|Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
1027092|NCT00753415|P9|Participant Flow|Part B: V934 HD(3)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
1027093|NCT00753415|P8|Participant Flow|Part B: V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
1027094|NCT00753415|P7|Participant Flow|Part B: V934 LD(3)+V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
1027095|NCT00753415|P6|Participant Flow|Part B: V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934-EP booster were administered, 1 given every 2 weeks.
1027096|NCT00753415|P5|Participant Flow|Part A: V934 HD(5)+V935 HD|Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
1027188|NCT00753272|B2|Baseline|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027097|NCT00753415|P4|Participant Flow|Part A: V934 HD(3)+V935 HD|Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
1027098|NCT00753415|P3|Participant Flow|Part A: V935 HD|Two IM injections of V935 high dose (HD), 1 given every other week over a 3-week period.
1027099|NCT00753415|P2|Participant Flow|Part A: V934 LD(3)+V935 LD|Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
1027100|NCT00753415|P1|Participant Flow|Part A: V935 LD|Two intramuscular (IM) injections of V935 low dose (LD), 1 given every other week over a 3-week period.
1027101|NCT00753415|O10|Outcome|Part B: V934 HD(5)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
1027102|NCT00753415|O9|Outcome|Part B: V934 HD(3)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
1027103|NCT00753415|O8|Outcome|Part B: V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, V934-EP booster was administered, 1 given every 2 weeks for 3 doses.
1027104|NCT00753415|O7|Outcome|Part B: V934 LD(3)+V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
1027105|NCT00753415|O6|Outcome|Part B: V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
1027106|NCT00753415|O5|Outcome|Part A: V934 HD(5)+V935 HD|Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
1027107|NCT00753415|O4|Outcome|Part A: V934 HD(3)+V935 HD|Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
1027108|NCT00753415|O3|Outcome|Part A: V935 HD|Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
1027109|NCT00753415|O2|Outcome|Part A: V934 LD(3)+V935 LD|Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
1027110|NCT00753415|O1|Outcome|Part A: V935 LD|Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
1027111|NCT00753415|O10|Outcome|Part B: V934 HD(5)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
1027112|NCT00753415|O9|Outcome|Part B: V934 HD(3)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
1027113|NCT00753415|O8|Outcome|Part B: V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
1027114|NCT00753415|O7|Outcome|Part B: V934 LD(3)+V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
1027115|NCT00753415|O6|Outcome|Part B: V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
1027116|NCT00753415|O5|Outcome|Part A: V934 HD(5)+V935 HD|Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
1027117|NCT00753415|O4|Outcome|Part A: V934 HD(3)+V935 HD|Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
1027118|NCT00753415|O3|Outcome|Part A: V935 HD|Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
1027119|NCT00753415|O2|Outcome|Part A: V934 LD(3)+V935 LD|Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
1027120|NCT00753415|O1|Outcome|Part A: V935 LD|Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
1027121|NCT00753415|O10|Outcome|Part B: V934 HD(5)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
1027164|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
1027122|NCT00753415|O9|Outcome|Part B: V934 HD(3)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
1027123|NCT00753415|O8|Outcome|Part B: V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
1027124|NCT00753415|O7|Outcome|Part B: V934 LD(3)+V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
1027125|NCT00753415|O6|Outcome|Part B: V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
1027126|NCT00753415|O5|Outcome|Part A: V934 HD(5)+V935 HD|Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
1075896|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
1027127|NCT00753415|O4|Outcome|Part A: V934 HD(3)+V935 HD|Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
1027128|NCT00753415|O3|Outcome|Part A: V935 HD|Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
1027129|NCT00753415|O2|Outcome|Part A: V934 LD(3)+V935 LD|Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
1027130|NCT00753415|O1|Outcome|Part A: V935 LD|Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
1027131|NCT00753415|E10|Reported Event|Part B: V934 HD(5)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
1027132|NCT00753415|E9|Reported Event|Part B: V934 HD(3)+V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
1027133|NCT00753415|E8|Reported Event|Part B: V935 HD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
1027134|NCT00753415|E7|Reported Event|Part B: V934 LD(3)+V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
1027135|NCT00753415|E6|Reported Event|Part B: V935 LD/V934 Booster|Participants who completed Part A could enter Part B. Following a 12-week observation, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
1027136|NCT00753415|E5|Reported Event|Part A: V934 HD(5)+V935 HD|Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
1027137|NCT00753415|E4|Reported Event|Part A: V934 HD(3)+V935 HD|Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
1027138|NCT00753415|E3|Reported Event|Part A: V935 HD|Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
1027139|NCT00753415|E2|Reported Event|Part A: V934 LD(3)+V935 LD|Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
1027140|NCT00753415|E1|Reported Event|Part A: V935 LD|Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
1027141|NCT00753363|B3|Baseline|Total|Total of all reporting groups
1027142|NCT00753363|B2|Baseline|Arm 2|"6 months of weight loss~Weight Loss: 6 months of weight loss"
1027143|NCT00753363|B1|Baseline|Arm 1|"6 months of aerobic exercise training~Aerobic Exercise Training: 6 months of aerobic exercise training"
1027144|NCT00753363|P2|Participant Flow|Arm 2|"6 months of weight loss~Weight Loss: 6 months of weight loss"
1027145|NCT00753363|P1|Participant Flow|Arm 1|"6 months of aerobic exercise training~Aerobic Exercise Training: 6 months of aerobic exercise training"
1027146|NCT00753363|O2|Outcome|Arm 2|"6 months of weight loss~Weight Loss: 6 months of weight loss"
1027147|NCT00753363|O1|Outcome|Arm 1|"6 months of aerobic exercise training~Aerobic Exercise Training: 6 months of aerobic exercise training"
1027148|NCT00753363|O2|Outcome|Arm 2|"6 months of weight loss~Weight Loss: 6 months of weight loss"
1027149|NCT00753363|O1|Outcome|Arm 1|"6 months of aerobic exercise training~Aerobic Exercise Training: 6 months of aerobic exercise training"
1027150|NCT00753363|O2|Outcome|Arm 2|"6 months of weight loss~Weight Loss: 6 months of weight loss"
1027151|NCT00753363|O1|Outcome|Arm 1|"6 months of aerobic exercise training~Aerobic Exercise Training: 6 months of aerobic exercise training"
1027152|NCT00753363|E2|Reported Event|Arm 2|"6 months of weight loss~Weight Loss: 6 months of weight loss"
1027153|NCT00753363|E1|Reported Event|Arm 1|"6 months of aerobic exercise training~Aerobic Exercise Training: 6 months of aerobic exercise training"
1027154|NCT00753337|B1|Baseline|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
1027155|NCT00753337|P1|Participant Flow|Assurant Cobalt Iliac Stent|Cobalt stent implanted using standard percutaneous intervention technique.
1027156|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting.
1027157|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
1027158|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
1027159|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
1027160|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
1027161|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
1027162|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
1027163|NCT00753337|O1|Outcome|Assurant Cobalt Iliac Stent|Treatment with iliac stenting
1027178|NCT00753298|O1|Outcome|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
1027179|NCT00753298|O2|Outcome|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
1027180|NCT00753298|O1|Outcome|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
1027181|NCT00753298|O2|Outcome|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
1027182|NCT00753298|O1|Outcome|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
1027183|NCT00753298|O2|Outcome|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
1027184|NCT00753298|O1|Outcome|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
1027185|NCT00753298|E2|Reported Event|LoFric Primo (PVC)|LoFric Primo (PVC) single-use urinary catheter (Arm B)
1027186|NCT00753298|E1|Reported Event|LoFric Primo (POBE)|LoFric Primo (POBE) single-use urinary catheter (Arm A)
1027187|NCT00753272|B3|Baseline|Total|Total of all reporting groups
1027189|NCT00753272|B1|Baseline|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027190|NCT00753272|P2|Participant Flow|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027191|NCT00753272|P1|Participant Flow|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027192|NCT00753272|O5|Outcome|FluNG Lot 3 Group|subjects received 1 dose of FluNG vaccine Lot 3 at Day 0 of the Year 1. They received Dose 2 at Day 0 of the Year 2, again from lot 3. The vaccine was administered intramuscularly in the non-dominant deltoid.
1027193|NCT00753272|O4|Outcome|FluNG Lot 2 Group|subjects received 1 dose of FluNG vaccine Lot 2 at Day 0 of the Year 1. They received Dose 2 at Day 0 of the Year 2, again from lot 2. The vaccine was administered intramuscularly in the non-dominant deltoid.
1027194|NCT00753272|O3|Outcome|FluNG Lot 1 Group|subjects received 1 dose of FluNG vaccine Lot 1 at Day 0 of the Year 1. They received Dose 2 at Day 0 of the Year 2, again from lot 1. The vaccine was administered intramuscularly in the non-dominant deltoid.
1027195|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027196|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027197|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027198|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027199|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027200|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027201|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027202|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027203|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027204|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027205|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027206|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027207|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027208|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027209|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027210|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027457|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
1027211|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027212|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027213|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027214|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027215|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027753|NCT00751036|O2|Outcome|Imatinib|Patients who were assigned to this treatment group received 400 mg. imatinib bid.
1027216|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027217|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027218|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027219|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027220|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027221|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027222|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027223|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027224|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027225|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027226|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027227|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027228|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027229|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027230|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027231|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027232|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027233|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027234|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027235|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027236|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027237|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027238|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1029082|NCT00746733|E1|Reported Event|Vyvanse|
1027239|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027240|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027241|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027242|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027243|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027244|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027245|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027246|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027247|NCT00753272|O5|Outcome|FluNG Lot 3 Group|subjects received 1 dose of FluNG vaccine Lot 3 at Day 0 of the Year 1. They received Dose 2 at Day 0 of the Year 2, again from lot 3. The vaccine was administered intramuscularly in the non-dominant deltoid.
1027248|NCT00753272|O4|Outcome|FluNG Lot 2 Group|subjects received 1 dose of FluNG vaccine Lot 2 at Day 0 of the Year 1. They received Dose 2 at Day 0 of the Year 2, again from lot 2. The vaccine was administered intramuscularly in the non-dominant deltoid.
1027249|NCT00753272|O3|Outcome|FluNG Lot 1 Group|subjects received 1 dose of FluNG vaccine Lot 1 at Day 0 of the Year 1. They received Dose 2 at Day 0 of the Year 2, again from lot 1. The vaccine was administered intramuscularly in the non-dominant deltoid.
1027250|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027251|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027252|NCT00753272|O2|Outcome|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027253|NCT00753272|O1|Outcome|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027254|NCT00753272|E2|Reported Event|Fluarix Group|subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027255|NCT00753272|E1|Reported Event|FluNG Group|subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
1027256|NCT00753220|B1|Baseline|VDC2008|"Cryoablation of prostate followed by dendritic cell injection into prostate and low dose cyclophosphamide therapy~VDC2008 : Intratumoral injection of VDC2008 post-cryotherapy.~Dosage will depend on cohort: 2.5 x 10^7, 7.5 x 10^7 or 1.0 x 10^8"
1027257|NCT00753220|P1|Participant Flow|VDC2008|"Cryoablation of prostate followed by dendritic cell injection into prostate and low dose cyclophosphamide therapy~VDC2008 : Intratumoral injection of VDC2008 post-cryotherapy.~Dosage will depend on cohort: 2.5 x 10^7, 7.5 x 10^7 or 1.0 x 10^8"
1027258|NCT00753220|O1|Outcome|VDC2008|"Cryoablation of prostate followed by dendritic cell injection into prostate and low dose cyclophosphamide therapy~VDC2008 : Intratumoral injection of VDC2008 post-cryotherapy.~Dosage will depend on cohort: 2.5 x 10^7, 7.5 x 10^7 or 1.0 x 10^8"
1027259|NCT00753220|E1|Reported Event|VDC2008|"Cryoablation of prostate followed by dendritic cell injection into prostate and low dose cyclophosphamide therapy~VDC2008 : Intratumoral injection of VDC2008 post-cryotherapy.~Dosage will depend on cohort: 2.5 x 10^7, 7.5 x 10^7 or 1.0 x 10^8"
1027260|NCT00753142|B4|Baseline|Total|Total of all reporting groups
1027261|NCT00753142|B3|Baseline|Nondiabetic Control Subjects|overweight/obese subjects without diabetes
1027262|NCT00753142|B2|Baseline|Subjects With Ketosis-resistant Diabetes|Diabetic subjects that presented with high blood glucose levels without ketosis at time of diagnosis
1027263|NCT00753142|B1|Baseline|Subjects With Ketosis-prone Diabetes|Diabetic subjects that presented with high blood glucose levels and ketosis at time of diagnosis
1027264|NCT00753142|P3|Participant Flow|Nondiabetic Control Subjects|overweight/obese subjects without diabetes
1027265|NCT00753142|P2|Participant Flow|Subjects With Ketosis-resistant Diabetes|Diabetic subjects that presented with high blood glucose levels without ketosis at time of diagnosis
1027266|NCT00753142|P1|Participant Flow|Subjects With Ketosis-prone Diabetes|Diabetic subjects that presented with high blood glucose levels and ketosis at time of diagnosis
1027267|NCT00753142|O3|Outcome|Nondiabetic Control Subjects|Overweight/obese subjects without diabetes
1027268|NCT00753142|O2|Outcome|Subjects With Ketosis-resistant Diabetes|Diabetic subjects that presented with high blood glucose levels without ketosis at time of diagnosis
1027269|NCT00753142|O1|Outcome|Subjects With Ketosis-prone Diabetes|Diabetic subjects that presented with high blood glucose levels and ketosis at time of diagnosis
1027270|NCT00753142|E3|Reported Event|Nondiabetic Control Subjects|Overweight/obese subjects without diabetes
1032444|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1027271|NCT00753142|E2|Reported Event|Subjects With Ketosis-resistant Diabetes|Diabetic subjects that presented with high blood glucose levels without ketosis at time of diagnosis
1027272|NCT00753142|E1|Reported Event|Subjects With Ketosis-prone Diabetes|Diabetic subjects that presented with high blood glucose levels and ketosis at time of diagnosis
1027273|NCT00753012|B3|Baseline|Total|Total of all reporting groups
1027274|NCT00753012|B2|Baseline|Primary Hypertensive Adults With ADHD|Group 2 is comprised of adults who meet the full DSM-IV criteria for ADHD, and who also high blood pressure being treated with stable doses of up to two FDA approved hypertensive medications to achieve a stable blood pressure of <135/85. High blood pressure is defined as 140-159mmHg/90-99 mmHg.
1027275|NCT00753012|B1|Baseline|Normotensive Adults With ADHD|Group 1 is comprised of adults who meet DSM-IV-TR criteria for ADHD and do not have high blood pressure.
1027305|NCT00752986|E3|Reported Event|Placebo to Match Vandetanib 100 mg and 300 mg|placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
1027276|NCT00753012|P2|Participant Flow|Primary Hypertensive Adults With ADHD|Group 2 is comprised of adults who meet the full DSM-IV criteria for ADHD, and who also high blood pressure being treated with stable doses of up to two FDA approved hypertensive medications to achieve a stable blood pressure of <135/85. High blood pressure is defined as 140-159mmHg/90-99 mmHg.
1027277|NCT00753012|P1|Participant Flow|Normotensive Adults With ADHD|Group 1 is comprised of adults who meet DSM-IV-TR criteria for ADHD and do not have high blood pressure.
1027278|NCT00753012|O2|Outcome|Primary Hypertensive Adults With ADHD|
1027279|NCT00753012|O1|Outcome|Normotensive Adults With ADHD|
1027280|NCT00753012|O2|Outcome|Primary Hypertensive Adults With ADHD|
1027281|NCT00753012|O1|Outcome|Normotensive Adults With ADHD|
1027282|NCT00753012|O2|Outcome|Primary Hypertensive Adults With ADHD|Group 2 is comprised of adults who meet the full DSM-IV criteria for ADHD, and who also high blood pressure being treated with stable doses of up to two FDA approved hypertensive medications to achieve a stable blood pressure of <135/85. High blood pressure is defined as 140-159mmHg/90-99 mmHg.
1027283|NCT00753012|O1|Outcome|Normotensive Adults With ADHD|
1027284|NCT00753012|E2|Reported Event|Primary Hypertensive Adults With ADHD|Group 2 is comprised of adults who meet the full DSM-IV criteria for ADHD, and who also high blood pressure being treated with stable doses of up to two FDA approved hypertensive medications to achieve a stable blood pressure of <135/85. High blood pressure is defined as 140-159mmHg/90-99 mmHg.
1027285|NCT00753012|E1|Reported Event|Normotensive Adults With ADHD|Group 1 is comprised of adults who meet DSM-IV-TR criteria for ADHD and do not have high blood pressure.
1027286|NCT00752986|B4|Baseline|Total|Total of all reporting groups
1027287|NCT00752986|B3|Baseline|Placebo to Match Vandetanib 100 mg and 300 mg|placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
1027288|NCT00752986|B2|Baseline|Vandetanib at the Dose of 300 mg|vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
1027289|NCT00752986|B1|Baseline|Vandetanib at the Dose of 100 mg|vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
1027290|NCT00752986|P3|Participant Flow|Placebo to Match Vandetanib 100 mg and 300 mg|placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
1027291|NCT00752986|P2|Participant Flow|Vandetanib at the Dose of 300 mg|vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
1027292|NCT00752986|P1|Participant Flow|Vandetanib at the Dose of 100 mg|vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
1027293|NCT00752986|O3|Outcome|Placebo to Match Vandetanib 100 mg and 300 mg|placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
1027294|NCT00752986|O2|Outcome|Vandetanib at the Dose of 300 mg|vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
1027295|NCT00752986|O1|Outcome|Vandetanib at the Dose of 100 mg|vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
1027296|NCT00752986|O3|Outcome|Placebo to Match Vandetanib 100 mg and 300 mg|placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
1027297|NCT00752986|O2|Outcome|Vandetanib at the Dose of 300 mg|vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
1027298|NCT00752986|O1|Outcome|Vandetanib at the Dose of 100 mg|vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
1027299|NCT00752986|O3|Outcome|Placebo to Match Vandetanib 100 mg and 300 mg|placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
1027300|NCT00752986|O2|Outcome|Vandetanib at the Dose of 300 mg|vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
1027301|NCT00752986|O1|Outcome|Vandetanib at the Dose of 100 mg|vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
1027597|NCT00751777|O1|Outcome|Group 1: 37.5 µg LT Patch|heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
1027302|NCT00752986|O3|Outcome|Placebo to Match Vandetanib 100 mg and 300 mg|placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
1027303|NCT00752986|O2|Outcome|Vandetanib at the Dose of 300 mg|vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
1027304|NCT00752986|O1|Outcome|Vandetanib at the Dose of 100 mg|vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
1027886|NCT00750308|P12|Participant Flow|Placebo, Ramipril, Tadalafil, Combo|
1027306|NCT00752986|E2|Reported Event|Vandetanib at the Dose of 300 mg|vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
1027307|NCT00752986|E1|Reported Event|Vandetanib at the Dose of 100 mg|vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
1027308|NCT00752973|B1|Baseline|MALG Treatment Arm|"MALG treatment~MALG (malathion) Treatment: MALG applied for 30 minutes"
1027309|NCT00752973|P1|Participant Flow|Malathion Gel 0.5% Treatment Arm|"Malathion Gel 0.5% treatment~MALG (Malathion Gel 0.5%) Treatment: MALG applied for 30 minutes"
1027310|NCT00752973|O1|Outcome|MALG (Malathion Gel, 0.5% )Treatment Arm|"MALG (Malathion Gel, 0.5% ) treatment~MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes~Subjects who reported signs or symptoms of cholinesterase inhibition pre treatment"
1027311|NCT00752973|O1|Outcome|MALG (Malathion Gel, 0.5% )Treatment Arm|"MALG (Malathion Gel, 0.5% ) treatment~MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes~Two subjects had out of range RBC cholinesterase values. One subject had out of range (low) value at baseline and One subject had out of range (low) value 1 h post treatment. Both these values were considered to be not clinically significant by the investigator."
1027312|NCT00752973|O1|Outcome|MALG (Malathion Gel, 0.5% )Treatment Arm|"MALG (Malathion Gel, 0.5% ) treatment~MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes~Subjects who reported signs or symptoms of cholinesterase inhibition pre treatment"
1027313|NCT00752973|O1|Outcome|MALG (Malathion Gel, 0.5% )Treatment Arm|"MALG (Malathion Gel, 0.5% ) treatment~MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes~Subjects who reported signs or symptoms of cholinesterase inhibition pre treatment"
1027314|NCT00752973|O1|Outcome|MALG (Malathion Gel, 0.5% )Treatment Arm|"MALG (Malathion Gel, 0.5% ) treatment~MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes~Subjects who reported signs or symptoms of cholinesterase inhibition pre treatment"
1027315|NCT00752973|O1|Outcome|MALG (Malathion Gel, 0.5% )Treatment Arm|"MALG (Malathion Gel, 0.5% ) treatment~MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes~A subject had out of range (low) RBC cholinesterase value 1 h post treatment. This value was considered to be not clinically significant by the investigator."
1027316|NCT00752973|O1|Outcome|MALG (Malathion Gel, 0.5% )Treatment Arm|"MALG (Malathion Gel, 0.5% ) treatment~MALG (Malathion Gel, 0.5% ) Treatment: MALG applied for 30 minutes~Two subjects had out of range RBC cholinesterase values. One subject had out of range (low) value at baseline and One subject had out of range (low) value 1 h post treatment. Both these values were considered to be not clinically significant by the investigator."
1027317|NCT00752973|E1|Reported Event|MALG Treatment Arm|"MALG treatment~MALG (malathion) Treatment: MALG applied for 30 minutes"
1027318|NCT00752895|B3|Baseline|Total|Total of all reporting groups
1027319|NCT00752895|B2|Baseline|Arm II - Placebo|"Patients receive oral placebo twice daily.~Placebo: Given orally"
1027320|NCT00752895|B1|Baseline|Arm I - Ginseng|"Patients receive oral American ginseng extract twice daily.~American ginseng: Given orally"
1027321|NCT00752895|P2|Participant Flow|Arm II - Placebo|"Patients receive oral placebo twice daily.~Placebo: Given orally"
1027322|NCT00752895|P1|Participant Flow|Arm I - Ginseng|"Patients receive oral American ginseng extract twice daily.~American ginseng: Given orally"
1027323|NCT00752895|O2|Outcome|Arm II - Placebo|"Patients receive oral placebo twice daily.~Placebo: Given orally"
1027324|NCT00752895|O1|Outcome|Arm I - Ginseng|"Patients receive oral American ginseng extract twice daily.~American ginseng: Given orally"
1027325|NCT00752895|O2|Outcome|Arm II - Placebo|"Patients receive oral placebo twice daily.~Placebo: Given orally"
1027326|NCT00752895|O1|Outcome|Arm I - Ginseng|"Patients receive oral American ginseng extract twice daily.~American ginseng: Given orally"
1027327|NCT00752895|E2|Reported Event|Arm II - Placebo|"Patients receive oral placebo twice daily.~Placebo: Given orally"
1027328|NCT00752895|E1|Reported Event|Arm I - Ginseng|"Patients receive oral American ginseng extract twice daily.~American ginseng: Given orally"
1027329|NCT00752791|B1|Baseline|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
1027330|NCT00752791|P1|Participant Flow|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
1027331|NCT00752791|O1|Outcome|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
1027332|NCT00752791|O1|Outcome|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
1027931|NCT00750282|O2|Outcome|HV (Specificity) Group (Part A)|All evaluated healthy volunteers from Part A
1027333|NCT00752791|O1|Outcome|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
1027334|NCT00752791|O1|Outcome|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
1027335|NCT00752791|O1|Outcome|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
1027754|NCT00751036|O1|Outcome|Nilotinib|Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
1027336|NCT00752791|O1|Outcome|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
1027337|NCT00752791|O1|Outcome|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
1027338|NCT00752791|E1|Reported Event|Peginesatide|Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
1027339|NCT00752726|B3|Baseline|Total|Total of all reporting groups
1027340|NCT00752726|B2|Baseline|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day. ITT population was considered for baseline measures.
1027341|NCT00752726|B1|Baseline|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day. Intent-to-treat (ITT) population was considered for baseline measures.
1027342|NCT00752726|P2|Participant Flow|Placebo|Placebo to match orlistat 60 mg capsules taken orally with meals 3 times per day
1027343|NCT00752726|P1|Participant Flow|Orlistat 60 Milligram (mg)|Orlistat 60 mg capsules taken orally with meals 3 times per day
1027344|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
1027345|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
1027346|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
1027347|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
1027348|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
1027349|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
1027350|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
1027351|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
1027352|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
1027353|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
1027354|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
1027355|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
1027356|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
1027357|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
1027358|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
1027359|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
1027360|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
1027361|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
1027362|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
1027363|NCT00752726|O2|Outcome|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
1027364|NCT00752726|O1|Outcome|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
1027365|NCT00752726|E2|Reported Event|Placebo|Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day
1027366|NCT00752726|E1|Reported Event|Orlistat 60 mg|Orlistat 60 mg capsules taken orally with meals 3 times per day
1027367|NCT00752622|B1|Baseline|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
1027368|NCT00752622|P1|Participant Flow|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
1027369|NCT00752622|O1|Outcome|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
1027370|NCT00752622|O1|Outcome|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
1027371|NCT00752622|O1|Outcome|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
1034358|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
1027372|NCT00752622|O1|Outcome|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
1027373|NCT00752622|O1|Outcome|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
1027374|NCT00752622|O1|Outcome|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
1027887|NCT00750308|P11|Participant Flow|Combo, Tadalafil, Ramipril, Placebo|
1027375|NCT00752622|O1|Outcome|Infliximab|Infliximab 5mg/kg intravenously (IV) at weeks 0, 2 and 6 during the induction phase and every 8 weeks during the observational phase and either 5mg/kg every 6 weeks or 7mg/kg every 8 weeks as determined by randomization at entry into the interventional phase.
1027376|NCT00752622|E2|Reported Event|Infliximab 5 mg/kg Then Randomized|Infliximab 5 mg/kg IV at weeks 0, 2 and 6 during the induction phase as well as every 8 weeks during the observational phase. Participants were then randomized to receive 5 mg/kg every 6 weeks (shortened interval group) or 7 mg/kg every 8 weeks (increased dose group) at entry into the interventional phase. This reporting group included 3 participants randomized into the shortened interval group and 5 participants randomized into the increased dose group.
1027377|NCT00752622|E1|Reported Event|Infliximab 5 mg/kg Then Not Randomized|Infliximab 5 mg/kg IV at weeks 0, 2 and 6 during the induction phase as well as every 8 weeks during the observational phase. Participants who were further randomized into the interventional phase are not included in this reporting group; therefore, of the 100 enrolled participants, 92 participants were included in this safety reporting group.
1027378|NCT00752609|B3|Baseline|Total|Total of all reporting groups
1027379|NCT00752609|B2|Baseline|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
1027380|NCT00752609|B1|Baseline|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
1027381|NCT00752609|P2|Participant Flow|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
1027382|NCT00752609|P1|Participant Flow|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
1027383|NCT00752609|O3|Outcome|Peginesatide - Not on Dialysis|Participants not on dialysis received 0.04 to 0.16 mg/kg Peginesatide subcutaneous injection, once every 4 weeks for 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
1027384|NCT00752609|O2|Outcome|SC Peginesatide - On Dialysis|Participants on dialysis received 0.04 to 0.16 mg/kg Peginesatide subcutaneous (SC) injection, once every 4 weeks for 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
1027385|NCT00752609|O1|Outcome|IV Peginesatide - On Dialysis|Participants on dialysis received 0.04 to 0.16 mg/kg Peginesatide intravenous (IV) injection once every 4 weeks for 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
1027386|NCT00752609|O2|Outcome|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
1027387|NCT00752609|O1|Outcome|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
1027388|NCT00752609|O2|Outcome|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
1027389|NCT00752609|O1|Outcome|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
1027390|NCT00752609|O2|Outcome|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
1027419|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
1028780|NCT00747344|B1|Baseline|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
1027391|NCT00752609|O1|Outcome|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
1027392|NCT00752609|O2|Outcome|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
1075897|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
1027393|NCT00752609|O1|Outcome|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
1027394|NCT00752609|O2|Outcome|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
1027395|NCT00752609|O1|Outcome|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
1027396|NCT00752609|O2|Outcome|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
1027397|NCT00752609|O1|Outcome|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
1027398|NCT00752609|E2|Reported Event|Peginesatide - Not on Dialysis|Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
1027399|NCT00752609|E1|Reported Event|Peginesatide - On Dialysis|Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
1027400|NCT00752232|B8|Baseline|Total|Total of all reporting groups
1027401|NCT00752232|B7|Baseline|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
1027402|NCT00752232|B6|Baseline|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
1027403|NCT00752232|B5|Baseline|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
1027404|NCT00752232|B4|Baseline|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
1027405|NCT00752232|B3|Baseline|ACC-001 10 Micrograms + QS-21|"A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day~1, month 3, 6, 9 and 12"
1027406|NCT00752232|B2|Baseline|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
1027407|NCT00752232|B1|Baseline|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
1027408|NCT00752232|P7|Participant Flow|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
1027409|NCT00752232|P6|Participant Flow|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
1027410|NCT00752232|P5|Participant Flow|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
1027411|NCT00752232|P4|Participant Flow|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
1027412|NCT00752232|P3|Participant Flow|ACC-001 10 Micrograms + QS-21|"A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day~1, month 3, 6, 9 and 12"
1027413|NCT00752232|P2|Participant Flow|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
1027414|NCT00752232|P1|Participant Flow|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
1027415|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
1027416|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
1027417|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
1027418|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
1027420|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
1027421|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
1027422|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
1027423|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
1075898|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
1027424|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
1027425|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
1027426|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
1027427|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
1027428|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
1027429|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
1027430|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
1027431|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
1027432|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
1027433|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
1027434|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
1027435|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
1027436|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
1027437|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
1027438|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
1027439|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
1027440|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
1027441|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
1027442|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
1027443|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
1027444|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
1027445|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
1027446|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
1027447|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
1027448|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
1027449|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
1027450|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
1027451|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
1027452|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
1027453|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
1027454|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
1027455|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
1027456|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
1027458|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
1027459|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
1027460|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
1027497|NCT00752089|O3|Outcome|NaF Dentifrice|Participants brushed their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF.
1027461|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
1027462|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
1027463|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
1027464|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
1027465|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
1027466|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
1027467|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
1027468|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day1, month 3, 6, 9 and 12
1027469|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
1027470|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
1027471|NCT00752232|O7|Outcome|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
1027472|NCT00752232|O6|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
1027473|NCT00752232|O5|Outcome|ACC-001 30 Micrograms +QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
1027474|NCT00752232|O4|Outcome|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12
1027475|NCT00752232|O3|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day1, month 3, 6, 9 and 12
1027476|NCT00752232|O2|Outcome|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
1027477|NCT00752232|O1|Outcome|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
1027478|NCT00752232|E7|Reported Event|Phosphate Buffered Saline (PBS)|A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12
1027479|NCT00752232|E6|Reported Event|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
1027480|NCT00752232|E5|Reported Event|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
1027481|NCT00752232|E4|Reported Event|ACC-001 30 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 3, 6, 9 and 12
1027482|NCT00752232|E3|Reported Event|ACC-001 10 Micrograms + QS-21|"A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day~1, month 3, 6, 9 and 12"
1027483|NCT00752232|E2|Reported Event|ACC-001 10 Micrograms|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
1027484|NCT00752232|E1|Reported Event|ACC-001 3 Micrograms +QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
1027485|NCT00752128|B1|Baseline|Resolute Drug-Eluting Stent|
1027486|NCT00752128|P1|Participant Flow|Resolute Drug-Eluting Stent|
1027487|NCT00752128|O1|Outcome|Overall Stent Thrombosis (Definite and Probable-ARC)|Overall stent thrombosis, defined as definite and probable stent thrombosis, according to the Academic Research Consortium (ARC) definition
1027488|NCT00752128|O1|Outcome|Cardiac Death or Target Vessel MI|Percentage of participants that had either Cardiac Death or Myocardial Infarction (not clearly attributable to a non-target vessel)
1027489|NCT00752128|E1|Reported Event|Resolute Drug-Eluting Stent|
1027490|NCT00752089|B1|Baseline|Overall Study Participants|All randomized participants who received all four treatments NaF/ KNO3/ 2% isopentane Dentifrice, NaF/KNO3/ 0% isopentane Dentifrice, NaF Dentifrice, and placebo were included in the baseline assessment.
1027491|NCT00752089|P1|Participant Flow|Overall Study|This was a single-center, examiner blind, randomized, controlled, four treatment cross-over study. Participants have used each study product twice per day for two weeks and participated in each of the four treatment periods.
1027492|NCT00752089|O4|Outcome|Placebo Dentifrice|Participants brushed their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F).
1027493|NCT00752089|O3|Outcome|NaF Dentifrice|Participants brushed their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF.
1027494|NCT00752089|O2|Outcome|NaF/ KNO3/ 0% Isopentane Dentifrice|Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane.
1027598|NCT00751777|E2|Reported Event|Group 2: 0 µg LT Patch (Placebo)|Placebo: Travelers' Diarrhea Vaccine System
1027495|NCT00752089|O1|Outcome|NaF/ KNO3/ 2% Isopentane Dentifrice|Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as NaF and 5% KNO3 and as an excipient ingredient: 2% isopentane.
1027496|NCT00752089|O4|Outcome|Placebo Dentifrice|Participants brushed their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F).
1027639|NCT00751530|O1|Outcome|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
1027498|NCT00752089|O2|Outcome|NaF/KNO3/ 0% Isopentane Dentifrice|Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane.
1027499|NCT00752089|O1|Outcome|NaF/ KNO3/ 2% Isopentane Dentifrice|Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as NaF and 5% KNO3 and as an excipient ingredient: 2% isopentane.
1027500|NCT00752089|E4|Reported Event|Placebo Dentifrice|Participants brushed their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F).
1027501|NCT00752089|E3|Reported Event|NaF Dentifrice|Participants brushed their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF.
1027502|NCT00752089|E2|Reported Event|NaF/KNO3/ 0% Isopentane Dentifrice|Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane.
1027503|NCT00752089|E1|Reported Event|NaF/ KNO3/ 2 % Isopentane Dentifrice|Participants brushed their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as NaF and 5% KNO3 and as an excipient ingredient: 2% isopentane.
1027504|NCT00751998|B1|Baseline|Arm 1|Test of SpyGlass device
1027505|NCT00751998|P1|Participant Flow|Arm 1|Test of SpyGlass device
1027506|NCT00751998|O1|Outcome|Arm 1|Test of SpyGlass device
1027507|NCT00751998|E1|Reported Event|Arm 1|Test of SpyGlass device
1027508|NCT00751972|B3|Baseline|Total|Total of all reporting groups
1027509|NCT00751972|B2|Baseline|Contemporaneous Control|Patients who received an FDA approved durable device for mechanically assisted support and enrolled into INTERMACS (NCT00119834) during the same enrollment period.
1027510|NCT00751972|B1|Baseline|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
1027511|NCT00751972|P2|Participant Flow|Contemporaneous Control|Patients who received an FDA approved durable device for mechanically assisted support and enrolled into INTERMACS during the same enrollment period.
1027512|NCT00751972|P1|Participant Flow|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
1027513|NCT00751972|O1|Outcome|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
1027514|NCT00751972|O1|Outcome|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
1027515|NCT00751972|O1|Outcome|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
1027516|NCT00751972|O1|Outcome|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
1027517|NCT00751972|O1|Outcome|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
1027518|NCT00751972|O2|Outcome|Contemporaneous Control|Patients who received an FDA approved durable device for mechanically assisted support and enrolled into INTERMACS during the same enrollment period.
1027519|NCT00751972|O1|Outcome|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
1027520|NCT00751972|O2|Outcome|Contemporaneous Control|Patients who received an FDA approved durable device for mechanically assisted support and enrolled into INTERMACS during the same enrollment period.
1027521|NCT00751972|O1|Outcome|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
1027522|NCT00751972|E1|Reported Event|HeartWare® VAS|Patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS)
1027523|NCT00751933|B1|Baseline|All Arms|Three patients entered the study, one man, two women. Age 24-41 years. The study was terminated due to lack of patients for inclusion.
1027524|NCT00751933|P4|Participant Flow|Vaccine and Oats 1|"Vaccination with Vivotif and Dukoral + dietary supplement with oats.~Vaccine Vivotif + Vaccine Dukoral + oats: Vivotif 1 capsule at study day 1,3,5 and 7.~Dukoral oral mixture taken with sodium hydrogen carbonate in water at study day 1 and 14.~One daily portion of oats porridge made from oats grain 1dL and water, 6 days a week for 6 months."
1027525|NCT00751933|P3|Participant Flow|Placebo 4|"Placebo instead of vaccines No dietary supplement~Placebo: Placebo capsules instead of Vivotif capsules Placebo mixture instead of liquid Dukoral vaccine"
1027526|NCT00751933|P2|Participant Flow|Oats Supplement 3|"Dietary supplement with oats~Oats: One daily portion of oats porridge made from oats grain 1dL and water, 6 days a week for 6 months."
1027527|NCT00751933|P1|Participant Flow|Vaccine Arm 2|"Vaccination with Vivotif and Dukoral~Vaccine Vivotif + Vaccine Dukoral: Vivotif 1 capsule at study day 1,3,5 and 7. Dukoral oral mixture taken with sodium hydrogen carbonate in water at study day 1 and 14."
1027528|NCT00751933|O1|Outcome|All Arms|No patient completed the study, therefore we have no information to report.
1027529|NCT00751933|O1|Outcome|All Arms|No patient completed the study, therefore we have no information to report.
1027530|NCT00751933|E1|Reported Event|All Arms|No adverse effects were recorded.
1027531|NCT00751881|B4|Baseline|Total|Total of all reporting groups
1027532|NCT00751881|B3|Baseline|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
1027533|NCT00751881|B2|Baseline|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
1027534|NCT00751881|B1|Baseline|Placebo / Teriflunomide 14 mg|Core treatment period: Placebo once daily. Extension treatment period: Teriflunomide 14 mg once daily.
1027535|NCT00751881|P3|Participant Flow|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
1027536|NCT00751881|P2|Participant Flow|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
1027537|NCT00751881|P1|Participant Flow|Placebo / Teriflunomide 14 mg|Core treatment period: Placebo (for teriflunomide) once daily. Extension treatment period: Teriflunomide 14 mg once daily.
1027538|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
1027539|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
1027540|NCT00751881|O1|Outcome|Placebo|Placebo once daily
1027640|NCT00751530|E2|Reported Event|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
1027541|NCT00751881|O3|Outcome|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
1027542|NCT00751881|O2|Outcome|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
1027543|NCT00751881|O1|Outcome|Placebo / Teriflunomide 14 mg|Core treatment period: Placebo once daily. Extension treatment period: Teriflunomide 14 mg once daily.
1027544|NCT00751881|O3|Outcome|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
1027545|NCT00751881|O2|Outcome|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
1027546|NCT00751881|O1|Outcome|Placebo / Teriflunomide 14 mg|Core treatment period: Placebo once daily. Extension treatment period: Teriflunomide 14 mg once daily.
1027547|NCT00751881|O3|Outcome|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
1027548|NCT00751881|O2|Outcome|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
1027549|NCT00751881|O1|Outcome|Placebo / Teriflunomide 14 mg|Core treatment period: Placebo once daily. Extension treatment period: Teriflunomide 14 mg once daily.
1027550|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
1027551|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
1027552|NCT00751881|O1|Outcome|Placebo|Placebo once daily
1027553|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
1027554|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
1027555|NCT00751881|O1|Outcome|Placebo|Placebo once daily
1027556|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
1027557|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
1027558|NCT00751881|O1|Outcome|Placebo|Placebo once daily
1027559|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
1027560|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
1027561|NCT00751881|O1|Outcome|Placebo|Placebo once daily
1027562|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
1027563|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
1027564|NCT00751881|O1|Outcome|Placebo|Placebo once daily
1027565|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
1027566|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
1027567|NCT00751881|O1|Outcome|Placebo|Placebo once daily
1027568|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
1027569|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
1027570|NCT00751881|O1|Outcome|Placebo|Placebo once daily
1027571|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
1027572|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
1027573|NCT00751881|O1|Outcome|Placebo|Placebo once daily
1027574|NCT00751881|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
1027575|NCT00751881|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
1027576|NCT00751881|O1|Outcome|Placebo|Placebo once daily
1027577|NCT00751881|E6|Reported Event|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
1027578|NCT00751881|E5|Reported Event|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
1027579|NCT00751881|E4|Reported Event|Placebo / 14 mg|Core treatment period: Placebo once daily. Extension treatment period: Teriflunomide 14 mg once daily
1027580|NCT00751881|E3|Reported Event|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
1027581|NCT00751881|E2|Reported Event|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
1027582|NCT00751881|E1|Reported Event|Placebo|Placebo once daily
1027583|NCT00751790|B1|Baseline|Triptorelin|Each subject received 2 injections of Triptorelin 22.5 mg at an interval of 24 weeks
1027584|NCT00751790|P1|Participant Flow|Triptorelin|Each subject received 2 injections of Triptorelin 22.5 mg at an interval of 24 weeks
1027585|NCT00751790|O1|Outcome|Triptorelin|Each subject received 2 injections of Triptorelin 22.5 mg at an interval of 24 weeks
1027586|NCT00751790|E1|Reported Event|Triptorelin|Each subject received 2 injections of Triptorelin 22.5 mg at an interval of 24 weeks
1027587|NCT00751777|B3|Baseline|Total|Total of all reporting groups
1027588|NCT00751777|B2|Baseline|Group 2: 0 µg LT Patch (Placebo)|Placebo: Travelers' Diarrhea Vaccine System
1027589|NCT00751777|B1|Baseline|Group 1: 37.5 µg LT Patch|heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
1027590|NCT00751777|P2|Participant Flow|Group 2: 0 µg LT Patch (Placebo)|Placebo: Travelers' Diarrhea Vaccine System
1027591|NCT00751777|P1|Participant Flow|Group 1: 37.5 µg LT Patch|heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
1027592|NCT00751777|O2|Outcome|Group 2: 0 µg LT Patch (Placebo)|Placebo: Travelers' Diarrhea Vaccine System
1027593|NCT00751777|O1|Outcome|Group 1: 37.5 µg LT Patch|heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
1027594|NCT00751777|O2|Outcome|Group 2: 0 µg LT Patch (Placebo)|Placebo: Travelers' Diarrhea Vaccine System
1027595|NCT00751777|O1|Outcome|Group 1: 37.5 µg LT Patch|heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
1027596|NCT00751777|O2|Outcome|Group 2: 0 µg LT Patch (Placebo)|Placebo: Travelers' Diarrhea Vaccine System
1027712|NCT00751140|O2|Outcome|Open RNU Lymph Node Count|Lymph Node Count for Open RNU Procedure Group
1027599|NCT00751777|E1|Reported Event|Group 1: 37.5 µg LT Patch|heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
1027600|NCT00751634|B1|Baseline|Treatment Group|Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
1027641|NCT00751530|E1|Reported Event|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
1027601|NCT00751634|P1|Participant Flow|Treatment Group|Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
1027602|NCT00751634|O1|Outcome|Treatment Group|Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
1027603|NCT00751634|O1|Outcome|Treatment Group|Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
1027604|NCT00751634|O1|Outcome|Treatment Group|Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
1027605|NCT00751634|O1|Outcome|Treatment Group|Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
1027606|NCT00751634|O1|Outcome|Treatment Group at 0, 1, 2, 6 Hours|Application of the Gaymar Rapr-Round device per approved use
1027607|NCT00751634|E1|Reported Event|Treatment Group|Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
1027608|NCT00751621|B1|Baseline|IgPro20|Subcutaneous (SC) administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
1027609|NCT00751621|P1|Participant Flow|IgPro20|Subcutaneous (SC) administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
1027610|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
1027611|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
1027612|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
1027613|NCT00751621|O2|Outcome|IgPro20 - At End of Study|SF-36 score at end of study (defined as the last available post-baseline observation for each subject).
1027614|NCT00751621|O1|Outcome|IgPro20 - At Baseline|SF-36 score at baseline.
1027615|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
1027616|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
1027617|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
1027618|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
1027619|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
1027620|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
1027621|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
1027622|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
1027623|NCT00751621|O1|Outcome|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
1027624|NCT00751621|E1|Reported Event|IgPro20|Subcutaneous administration by the subject/parent/guardian with the planned weekly dose of IgPro20 to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR (NCT00542997).
1027625|NCT00751530|B3|Baseline|Total|Total of all reporting groups
1027626|NCT00751530|B2|Baseline|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
1027627|NCT00751530|B1|Baseline|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
1027628|NCT00751530|P2|Participant Flow|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
1027629|NCT00751530|P1|Participant Flow|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
1027630|NCT00751530|O2|Outcome|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
1027631|NCT00751530|O1|Outcome|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
1027632|NCT00751530|O2|Outcome|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
1027633|NCT00751530|O1|Outcome|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
1027634|NCT00751530|O2|Outcome|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
1027635|NCT00751530|O1|Outcome|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
1027636|NCT00751530|O2|Outcome|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
1034359|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
1027637|NCT00751530|O1|Outcome|Protease Inhibitor Group|Subjects who required a protease inhibitor in their new ART regimen
1027638|NCT00751530|O2|Outcome|Non-protease Inhibitor|Subjects who did not take a protease inhibitor in their regimen
1027888|NCT00750308|P10|Participant Flow|Ramipril, Placebo, Combo, Tadalafil|
1027642|NCT00751400|B1|Baseline|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
1027643|NCT00751400|P1|Participant Flow|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
1027644|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
1027645|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
1027646|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
1027647|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
1027648|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
1027649|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
1027650|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
1027651|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
1027652|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
1027653|NCT00751400|O1|Outcome|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
1027654|NCT00751400|E1|Reported Event|Naproxen Sodium ER (BAYH6689)|subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
1027655|NCT00751348|B3|Baseline|Total|Total of all reporting groups
1027656|NCT00751348|B2|Baseline|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
1027657|NCT00751348|B1|Baseline|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
1027658|NCT00751348|P2|Participant Flow|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
1027659|NCT00751348|P1|Participant Flow|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
1027660|NCT00751348|O2|Outcome|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
1027661|NCT00751348|O1|Outcome|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
1027662|NCT00751348|O2|Outcome|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
1027663|NCT00751348|O1|Outcome|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
1027664|NCT00751348|O2|Outcome|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
1027665|NCT00751348|O1|Outcome|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
1027713|NCT00751140|O1|Outcome|Total Lymph Node Count|Total Lymph Node Count for All Participants
1027749|NCT00751036|O2|Outcome|Imatinib|Patients who were assigned to this treatment group received 400 mg. imatinib bid.
1027666|NCT00751348|O2|Outcome|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
1027667|NCT00751348|O1|Outcome|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
1075899|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
1027668|NCT00751348|O2|Outcome|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
1027669|NCT00751348|O1|Outcome|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
1027670|NCT00751348|O2|Outcome|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
1027671|NCT00751348|O1|Outcome|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
1027672|NCT00751348|O2|Outcome|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
1027673|NCT00751348|O1|Outcome|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
1027674|NCT00751348|O2|Outcome|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
1027675|NCT00751348|O1|Outcome|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
1027676|NCT00751348|O2|Outcome|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
1027677|NCT00751348|O1|Outcome|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
1027678|NCT00751348|E2|Reported Event|Priorix + Varilrix Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
1027679|NCT00751348|E1|Reported Event|Priorix-Tetra Group|Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
1027680|NCT00751296|B1|Baseline|Lenalidiomide|"Lenalidomide target dose of 10 mg PO OD X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28-day cycle.~Lenalidomide: Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle. Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles)."
1027681|NCT00751296|P1|Participant Flow|Lenalidiomide|"Lenalidomide target dose of 10 mg PO OD X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28-day cycle.~Lenalidomide: Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle. Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).~Dose escalation beyond 10 mg daily to a maximum of 25 mgs daily was permitted for nonresponders."
1027682|NCT00751296|O1|Outcome|Lenalidiomide|"Lenalidomide target dose of 10 mg PO OD X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28-day cycle.~Lenalidomide: Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle. Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).~Dose escalation beyond 10 mg daily to a maximum of 25 mgs daily was permitted for nonresponders."
1027683|NCT00751296|O1|Outcome|Lenalidiomide|"Lenalidomide target dose of 10 mg PO OD X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28-day cycle.~Lenalidomide: Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle. Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).~Dose escalation beyond 10 mg daily to a maximum of 25 mgs daily was permitted for nonresponders."
1027684|NCT00751296|E1|Reported Event|Lenalidiomide|"Lenalidomide target dose of 10 mg PO OD X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28-day cycle.~Lenalidomide: Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle. Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).~Dose escalation beyond 10 mg daily to a maximum of 25 mgs daily was permitted for nonresponders."
1027685|NCT00751179|B3|Baseline|Total|Total of all reporting groups
1027686|NCT00751179|B2|Baseline|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
1027687|NCT00751179|B1|Baseline|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
1027688|NCT00751179|P2|Participant Flow|Succinylcholine|An intubation dose of succinylcholine (suc) was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
1075900|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
1027689|NCT00751179|P1|Participant Flow|Rocuronium - Sugammadex|An intubation dose of rocuronium (roc) was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex (sug) was administered for reversal of neuromuscular blockade.
1027690|NCT00751179|O1|Outcome|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
1027691|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
1027692|NCT00751179|O2|Outcome|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
1027693|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
1027694|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
1027695|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
1027696|NCT00751179|O2|Outcome|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
1027697|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
1027698|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
1027699|NCT00751179|O2|Outcome|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
1027700|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
1027701|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
1027702|NCT00751179|O2|Outcome|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
1027703|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
1027704|NCT00751179|O2|Outcome|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
1027705|NCT00751179|O1|Outcome|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
1027706|NCT00751179|E2|Reported Event|Succinylcholine|An intubation dose of succinylcholine was administered following induction of anesthesia and the subject was allowed to recover spontaneously from the neuromuscular blockade.
1027707|NCT00751179|E1|Reported Event|Rocuronium - Sugammadex|An intubation dose of rocuronium was administered following induction of anesthesia and, if required, maintenance doses were administered to maintain the neuromuscular block. At the end of the surgical procedure sugammadex was administered for reversal of neuromuscular blockade.
1027708|NCT00751140|B1|Baseline|Lymph Node Dissection at Time of Nephroureterectomy|"A prospective single-arm two-stage phase II study to allow for analysis of the treatment-specific outcomes and disease-specific survival of patients treated with open or laparoscopic nephroureterectomy and bladder cuff excision along with a lymph node dissection (modified template retroperitoneal lymph node dissection).~Lymph Node Dissection : The lymph nodes will be sent to pathology for review."
1027709|NCT00751140|P1|Participant Flow|Lymph Node Dissection at Time of Nephroureterectomy|"A prospective single-arm two-stage phase II study to allow for analysis of the treatment-specific outcomes and disease-specific survival of patients treated with open or laparoscopic nephroureterectomy and bladder cuff excision along with a lymph node dissection (modified template retroperitoneal lymph node dissection).~Lymph Node Dissection : The lymph nodes will be sent to pathology for review."
1027710|NCT00751140|O4|Outcome|Robot-assisted RNU Lymph Node Count|Lymph Node Count for Robot-assisted RNU Procedure Group
1027711|NCT00751140|O3|Outcome|Laparoscopic RNU Lymph Node Count|Lymph Node Count for Laparoscopic RNU Procedure Group
1027714|NCT00751140|O1|Outcome|Lymph Node Dissection at Time of Nephroureterectomy|"A prospective single-arm two-stage phase II study to allow for analysis of the treatment-specific outcomes and disease-specific survival of patients treated with open or laparoscopic nephroureterectomy and bladder cuff excision along with a lymph node dissection (modified template retroperitoneal lymph node dissection).~Lymph Node Dissection : The lymph nodes will be sent to pathology for review."
1027889|NCT00750308|P9|Participant Flow|Tadalafil, Combo, Placebo, Ramipril|
1027715|NCT00751140|E1|Reported Event|Lymph Node Dissection at Time of Nephroureterectomy|"A prospective single-arm two-stage phase II study to allow for analysis of the treatment-specific outcomes and disease-specific survival of patients treated with open or laparoscopic nephroureterectomy and bladder cuff excision along with a lymph node dissection (modified template retroperitoneal lymph node dissection).~Lymph Node Dissection : The lymph nodes will be sent to pathology for review."
1027716|NCT00751114|B3|Baseline|Total|Total of all reporting groups
1027717|NCT00751114|B2|Baseline|Sitagliptin|Dose of 100 mg once a day administered with or without food
1027718|NCT00751114|B1|Baseline|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
1027719|NCT00751114|P2|Participant Flow|Sitagliptin|Dose of 100 mg once a day administered with or without food
1027720|NCT00751114|P1|Participant Flow|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the Fasting Plasma Glucose (FPG) target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
1027721|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
1027722|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
1027723|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
1027724|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
1027725|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
1027726|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
1027727|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
1027728|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
1027729|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
1027730|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
1027731|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
1027732|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
1027733|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
1027734|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
1027735|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
1027736|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
1027737|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
1027738|NCT00751114|O2|Outcome|Sitagliptin|Dose of 100 mg once a day administered with or without food
1027739|NCT00751114|O1|Outcome|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
1027740|NCT00751114|E2|Reported Event|Sitagliptin|Dose of 100 mg once a day administered with or without food
1027741|NCT00751114|E1|Reported Event|Insulin Glargine|Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL<FPG≤100mg/dL (3.9mmol/L<FPG≤5.5mmol/L)
1027742|NCT00751036|B3|Baseline|Total|Total of all reporting groups
1027743|NCT00751036|B2|Baseline|Imatinib|Patients who were assigned to this treatment group received 400 mg. imatinib bid.
1027744|NCT00751036|B1|Baseline|Nilotinib|Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
1027745|NCT00751036|P2|Participant Flow|Imatinib|Patients who were assigned to this treatment group received 400 mg. imatinib bid.
1027746|NCT00751036|P1|Participant Flow|Nilotinib|Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
1027747|NCT00751036|O2|Outcome|Imatinib|Patients who were assigned to this treatment group received 400 mg. imatinib bid.
1027748|NCT00751036|O1|Outcome|Nilotinib|Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
1027750|NCT00751036|O1|Outcome|Nilotinib|Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
1027751|NCT00751036|O2|Outcome|Imatinib|Patients who were assigned to this treatment group received 400 mg. imatinib bid.
1027752|NCT00751036|O1|Outcome|Nilotinib|Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
1027890|NCT00750308|P8|Participant Flow|Placebo, Tadalafil, Combo, Ramipril|
1027755|NCT00751036|E2|Reported Event|Imatinib 800 mg|Patients who were assigned to this treatment group received 400 mg. imatinib bid.
1027756|NCT00751036|E1|Reported Event|Nilotinib 800 mg|Patients who were assigned to this treatment group received 400 mg. nilotinib bid.
1027757|NCT00750919|B1|Baseline|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
1027758|NCT00750919|P1|Participant Flow|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
1027759|NCT00750919|O1|Outcome|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
1027760|NCT00750919|O1|Outcome|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
1027761|NCT00750919|O1|Outcome|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
1027762|NCT00750919|O1|Outcome|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
1027763|NCT00750919|O1|Outcome|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
1027764|NCT00750919|E1|Reported Event|Esmirtazapine|Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
1027765|NCT00750893|B1|Baseline|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
1027766|NCT00750893|P1|Participant Flow|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
1027767|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
1027768|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
1027769|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
1027770|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
1027771|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
1027772|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
1027773|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
1027774|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
1027775|NCT00750893|O1|Outcome|Rotarix Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
1027776|NCT00750893|E4|Reported Event|Rotarix Year 1 to Year 6 Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age. This group contains the subjects enrolled during the study period from Year 1 to Year 6.
1027777|NCT00750893|E3|Reported Event|Rotarix Year 5 Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age. This group contains the subjects enrolled during Year 5 of the study.
1027778|NCT00750893|E2|Reported Event|Rotarix Years 3 and 4 Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age. This group contains the subjects enrolled during Years 3 and 4 of the study.
1027779|NCT00750893|E1|Reported Event|Rotarix Years 1 and 2 Group|Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age. This group contains the subjects enrolled during Years 1 and 2 of the study.
1027780|NCT00750880|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
1027781|NCT00750880|P1|Participant Flow|Tocilizumab (TCZ) 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg intravenously (IV) once every 4 weeks for 20 weeks (total of 6 infusions).
1034360|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
1027782|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
1027783|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
1027784|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
1027785|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
1027786|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
1027787|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
1027788|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
1027789|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
1027790|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
1027791|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
1027792|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
1027793|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
1027794|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
1027795|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
1027796|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
1027797|NCT00750880|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv infusions every 4 weeks for 24 weeks.
1027798|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
1027799|NCT00750880|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv infusions every 4 weeks for 24 weeks.
1027800|NCT00750880|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
1027801|NCT00750880|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg iv infusions every 4 weeks for 24 weeks.
1027802|NCT00750880|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 20 weeks (total of 6 infusions).
1027803|NCT00750867|B1|Baseline|Open Label Interventional Arm|intravenous immunoglobulin (IVIg): The IVIg will be infused intravenously, monthly, 6 times, the dose will be 0.4 gram/kg for each infusion.
1027804|NCT00750867|P1|Participant Flow|Open Label Interventional Arm|intravenous immunoglobulin (IVIg): The IVIg will be infused intravenously, monthly, 6 times, the dose will be 0.4 gram/kg for each infusion.
1027805|NCT00750867|O1|Outcome|Open Label Interventional Arm|intravenous immunoglobulin (IVIg): The IVIg will be infused intravenously, monthly, 6 times, the dose will be 0.4 gram/kg for each infusion.
1027806|NCT00750867|O1|Outcome|Open Label Interventional Arm|intravenous immunoglobulin (IVIg): The IVIg will be infused intravenously, monthly, 6 times, the dose will be 0.4 gram/kg for each infusion.
1027807|NCT00750867|E1|Reported Event|Open Label Interventional Arm|intravenous immunoglobulin (IVIg): The IVIg will be infused intravenously, monthly, 6 times, the dose will be 0.4 gram/kg for each infusion.
1027808|NCT00750815|B3|Baseline|Total|Total of all reporting groups
1027809|NCT00750815|B2|Baseline|B. Phase II - Maximum Planned Dose (MPD)|Participants received Cyclophosphamide and VELCADE at the MPD at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule as the Phase I part of study.
1027810|NCT00750815|B1|Baseline|A. Phase I - Dose Escalation|"Dose of Cyclophosphamide depended on how many patients we had treated:~Dose Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12"
1027811|NCT00750815|P2|Participant Flow|B. Phase II - Maximum Planned Dose (MPD)|Participants received Cyclophosphamide and VELCADE at Level 4 (the MPD) at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule as the Phase I part of study.
1027812|NCT00750815|P1|Participant Flow|A. Phase I - Dose Escalation|"Dose of Cyclophosphamide depended on how many patients we had treated. Three participants were treated at each level:~Dose Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12"
1027838|NCT00750373|O2|Outcome|Surgery|Early surgery within 48 hours of randomization
1027839|NCT00750373|O1|Outcome|Conventional|Conventional Treatment based on current guidelines
1027840|NCT00750373|E2|Reported Event|Surgery|Early surgery within 48 hours of randomization
1027841|NCT00750373|E1|Reported Event|Conventional|Conventional Treatment based on current guidelines
1027842|NCT00750360|B7|Baseline|Total|Total of all reporting groups
1034361|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
1027843|NCT00750360|B6|Baseline|Primed, ≥ 216 Months|Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
1027844|NCT00750360|B5|Baseline|Primed, ≥ 108 to < 216 Months|Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
1027845|NCT00750360|B4|Baseline|Primed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
1027891|NCT00750308|P7|Participant Flow|Combo, Ramipril, Placebo, Tadalafil|
1027813|NCT00750815|O2|Outcome|Standard-Risk Myeloma|"Participants eligible for risk stratification with Standard-Risk Myeloma.~Arm A:~Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Arm B:~Cyclophosphamide and VELCADE at Level 4 (the MPD) at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule Arm A."
1027814|NCT00750815|O1|Outcome|High-Risk Myeloma|"Participants eligible for risk stratification with High-Risk Myeloma.~Arm A:~Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Arm B:~Cyclophosphamide and VELCADE at Level 4 (the MPD) at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule as Arm A."
1027815|NCT00750815|O1|Outcome|All Participants|"Arm A:~Dose Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Arm B:~Participants received Cyclophosphamide and VELCADE at Level 4 (the MPD) at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule as the Phase I part of study."
1027816|NCT00750815|O1|Outcome|All Participants|"Arm A:~Dose Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Arm B:~Participants received Cyclophosphamide and VELCADE at Level 4 (the MPD) at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule as the Phase I part of study."
1027817|NCT00750815|O1|Outcome|A. Phase I Dose Escalation|"Dose of Cyclophosphamide depended on how many patients we had treated. Three participants were treated at each level:~Dose Level 1: Cyclophosphamide 250 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 2: Cyclophosphamide 500 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 3: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.0 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12~Dose Level 4: Cyclophosphamide 750 mg /m^2 IV Day 1; VELCADE, 1.3 mg/m^2 IV days 1,4,8, and 11; DOXIL 30 mg/m^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12"
1027818|NCT00750815|E4|Reported Event|Maximum Tolerated Dose|Participants at Dose Level 4
1027819|NCT00750815|E3|Reported Event|Dose Level 3|Participants at Dose Level 3
1027820|NCT00750815|E2|Reported Event|Dose Level 2|Participants at Dose Level 2
1027821|NCT00750815|E1|Reported Event|Dose Level 1|Participants at Dose Level 1
1027822|NCT00750737|B3|Baseline|Total|Total of all reporting groups
1027823|NCT00750737|B2|Baseline|Amphotericin B Lipid Complex (ABLC) 7.5 mg/kg IV|7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)
1027824|NCT00750737|B1|Baseline|Posaconazole 200 mg Oral|Posaconazole 200 mg three times daily by mouth up to 6 weeks (Days 1-42)
1027825|NCT00750737|P2|Participant Flow|Amphotericin B Lipid Complex (ABLC) 7.5 mg/kg IV|7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)
1027826|NCT00750737|P1|Participant Flow|Posaconazole 200 mg Oral|Posaconazole 200 mg three times daily by mouth up to 6 weeks (Days 1-42)
1027827|NCT00750737|O2|Outcome|Amphotericin B Lipid Complex (ABLC) 7.5 mg/kg IV|7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)
1027828|NCT00750737|O1|Outcome|Posaconazole 200 mg Oral|Posaconazole 200 mg three times daily by mouth up to 6 weeks (Days 1-42)
1027829|NCT00750737|O2|Outcome|Amphotericin B Lipid Complex (ABLC) 7.5 mg/kg IV|7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)
1027830|NCT00750737|O1|Outcome|Posaconazole 200 mg Oral|Posaconazole 200 mg three times daily by mouth up to 6 weeks (Days 1-42)
1027831|NCT00750737|E2|Reported Event|Amphotericin B Lipid Complex (ABLC) 7.5 mg/kg IV|7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)
1027832|NCT00750737|E1|Reported Event|Posaconazole 200 mg Oral|Posaconazole 200 mg three times daily by mouth up to 6 weeks (Days 1-42)
1027833|NCT00750373|B3|Baseline|Total|Total of all reporting groups
1027834|NCT00750373|B2|Baseline|Surgery|Early surgery within 48 hours of randomization
1027835|NCT00750373|B1|Baseline|Conventional|Conventional Treatment based on current guidelines
1027836|NCT00750373|P2|Participant Flow|Surgery|Early surgery within 48 hours of randomization
1027837|NCT00750373|P1|Participant Flow|Conventional|Conventional Treatment based on current guidelines
1027846|NCT00750360|B3|Baseline|Primed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
1027847|NCT00750360|B2|Baseline|Unprimed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
1027848|NCT00750360|B1|Baseline|Unprimed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
1027849|NCT00750360|P6|Participant Flow|Primed, ≥ 216 Months|Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
1027850|NCT00750360|P5|Participant Flow|Primed, ≥ 108 to < 216 Months|Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
1027851|NCT00750360|P4|Participant Flow|Primed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
1027852|NCT00750360|P3|Participant Flow|Primed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
1027853|NCT00750360|P2|Participant Flow|Unprimed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
1027854|NCT00750360|P1|Participant Flow|Unprimed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
1027855|NCT00750360|O6|Outcome|Primed, ≥ 216 Months|Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
1027856|NCT00750360|O5|Outcome|Primed, ≥ 108 to < 216 Months|Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
1027857|NCT00750360|O4|Outcome|Primed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
1027858|NCT00750360|O3|Outcome|Primed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
1027859|NCT00750360|O2|Outcome|Unprimed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
1027860|NCT00750360|O1|Outcome|Unprimed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
1027861|NCT00750360|O6|Outcome|Primed, ≥ 216 Months|Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
1027862|NCT00750360|O5|Outcome|Primed, ≥ 108 to < 216 Months|Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
1027863|NCT00750360|O4|Outcome|Primed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
1027864|NCT00750360|O3|Outcome|Primed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
1027865|NCT00750360|O2|Outcome|Unprimed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
1027866|NCT00750360|O1|Outcome|Unprimed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
1027867|NCT00750360|O4|Outcome|Group A (Primed), ≥ 216 Months|Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
1027868|NCT00750360|O3|Outcome|Group A (Primed), ≥ 108 Months to < 216 Months|Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
1027869|NCT00750360|O2|Outcome|Group A (Primed), ≥ 72 Months to < 108 Months|Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
1027870|NCT00750360|O1|Outcome|Group B (Unprimed), ≥ 72 Months to < 108 Months|Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
1027871|NCT00750360|O2|Outcome|Group A (Primed), > 6 Months to < 72 Months|Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
1027872|NCT00750360|O1|Outcome|Group B (Unprimed), > 6 Months to < 72 Months|Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
1027873|NCT00750360|O6|Outcome|Primed, ≥ 216 Months|Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
1027874|NCT00750360|O5|Outcome|Primed, ≥ 108 to < 216 Months|Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
1027875|NCT00750360|O4|Outcome|Primed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
1027876|NCT00750360|O3|Outcome|Primed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
1027877|NCT00750360|O2|Outcome|Unprimed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
1027878|NCT00750360|O1|Outcome|Unprimed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
1027879|NCT00750360|E6|Reported Event|Primed, ≥ 216 Months|Subjects aged ≥ 216 months who previously received a vaccination against influenza (primed).
1027880|NCT00750360|E5|Reported Event|Primed, ≥ 108 to < 216 Months|Subjects aged ≥ 108 months to < 216 months who previously received a vaccination against influenza (primed).
1027881|NCT00750360|E4|Reported Event|Primed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who previously received a vaccination against influenza (primed).
1027882|NCT00750360|E3|Reported Event|Primed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who previously received a vaccination against influenza (primed).
1027930|NCT00750282|O3|Outcome|AD (Sensitivity) Group (Part B)|All evaluated subjects with probable Alzheimer's disease from part B
1027883|NCT00750360|E2|Reported Event|Unprimed, ≥ 72 to < 108 Months|Subjects aged ≥ 72 months to < 108 months who were previously not vaccinated against influenza (unprimed).
1027884|NCT00750360|E1|Reported Event|Unprimed, > 6 to < 72 Months|Subjects aged > 6 months to < 72 months who were previously not vaccinated against influenza (unprimed).
1027885|NCT00750308|B1|Baseline|Completed Subjects|Subjects who completed all four treatment arms.
1027892|NCT00750308|P6|Participant Flow|Ramipril, Combo, Tadalafil, Placebo|
1027893|NCT00750308|P5|Participant Flow|Tadalafil, Placebo, Ramipril, Combo|
1027894|NCT00750308|P4|Participant Flow|Placebo, Combo, Ramipril, Tadalafil|
1027895|NCT00750308|P3|Participant Flow|Combo, Placebo, Tadalafil, Ramipril|
1027896|NCT00750308|P2|Participant Flow|Ramipril, Tadalafil, Placebo, Combo|
1027897|NCT00750308|P1|Participant Flow|Tadalafil, Ramipril, Combo, Placebo|
1027898|NCT00750308|O4|Outcome|Combination Treatment|Measured during combination (ramipril and tadalafil) in all 18 subjects who completed treatment
1027899|NCT00750308|O3|Outcome|Tadalafil Treatment|Measured during tadalafil in all 18 subjects who completed the protocol
1027900|NCT00750308|O2|Outcome|Ramipril Treatment|Measured during ramipril treatment in all 18 subjects who completed the protocol
1027901|NCT00750308|O1|Outcome|Placebo Treatment|Measured during placebo treatment in all 18 subjects who completed the study
1027902|NCT00750308|O4|Outcome|Combination Treatment|Measurements during combination (ramipril and tadalafil) for all 18 subjects who completed the protocol
1027903|NCT00750308|O3|Outcome|Tadalafil Treatment|Measurements during tadalafil treatment for all 18 subjects who completed the protocol
1027904|NCT00750308|O2|Outcome|Ramipril Treatment|Measurements during ramipril treatment for all 18 subjects who completed the protocol
1027905|NCT00750308|O1|Outcome|Placeb Treatment|Measurements during placebo treatment for all 18 subjects who completed the protocol
1027906|NCT00750308|E4|Reported Event|Combination Treatment|Any adverse event that occurred during combination (ramipril and tadalafil) treatment in anyone who received combination treatment
1027907|NCT00750308|E3|Reported Event|Tadalafil Tretament|Any adverse event that occurred during tadalafil treatment in anyone who received tadalafil treatment
1027908|NCT00750308|E2|Reported Event|Ramipril Treatment|Any adverse event that occured durng ramipril treatment in anyone who received ramipril treatment
1027909|NCT00750308|E1|Reported Event|Placebo Treatment|Any adverse event that occurred during placebo treatment in anyone who received placebo treatment
1027910|NCT00750282|B5|Baseline|Total|Total of all reporting groups
1027911|NCT00750282|B4|Baseline|Part B Alzheimer Patients|Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
1027912|NCT00750282|B3|Baseline|Part B Healthy Volunteers|Florbetaben (BAY94-9172) : Healthy volunteers receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
1027913|NCT00750282|B2|Baseline|Part A Alzheimer Patients|Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
1027914|NCT00750282|B1|Baseline|Part A Healthy Volunteers|Florbetaben (BAY94-9172) : Healthy volunteers receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
1027915|NCT00750282|P4|Participant Flow|Part B Alzheimer Patients|Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
1027916|NCT00750282|P3|Participant Flow|Part B Healthy Volunteers|Florbetaben (BAY94-9172) : Healthy volunteers receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
1027917|NCT00750282|P2|Participant Flow|Part A Alzheimer Patients|Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
1027918|NCT00750282|P1|Participant Flow|Part A Healthy Volunteers|Florbetaben (BAY94-9172) : Healthy volunteers receiving 300 megabequerel (MBq) single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions.
1027919|NCT00750282|O4|Outcome|Healthy Volunteer (HV) Group (Part B)|All subjects that were confirmed by consensus panel as healthy volunteers
1027920|NCT00750282|O3|Outcome|Alzheimer's (AD) Group (Part B)|"All subjects with consensus panel based diagnosis of probable AD"
1027921|NCT00750282|O2|Outcome|Healthy Volunteer (HV) Group (Part A)|All evaluated healthy volunteers
1027922|NCT00750282|O1|Outcome|Alzheimer's (AD) Group (Part A)|All evaluated subjects with Alzheimer's disease
1027923|NCT00750282|O6|Outcome|Imaging Window 110-130 Min Part B|Kappa coefficient estimate for PET data collected 110-130 min post-injection in Part B.
1027924|NCT00750282|O5|Outcome|Imaging Window 90-110 Min Part B|Kappa coefficient estimate for PET data collected 90-110 min post-injection in Part B
1027925|NCT00750282|O4|Outcome|Imaging Window 45-60 Min Part B|Kappa coefficient estimate for PET data collected 45-60 min post-injection in Part B
1027926|NCT00750282|O3|Outcome|Imaging Window 110-130 Min Part A|Kappa coefficient estimate for PET data collected 110-130 min post-injection in Part A.
1027927|NCT00750282|O2|Outcome|Imaging Window 90-110 Min Part A|Kappa coefficient estimate for PET data collected 90-110 min post-injection in Part A
1027928|NCT00750282|O1|Outcome|Imaging Window 45-60 Min Part A|Kappa coefficient estimate for PET data collected 45-60 min post-injection in Part A
1027929|NCT00750282|O4|Outcome|HV (Specificity) Group (Part B)|All evaluated healthy volunteers from Part B
1034362|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
1027932|NCT00750282|O1|Outcome|AD (Sensitivity) Group (Part A)|All evaluated subjects with Alzheimer's disease from Part A
1027933|NCT00750282|O2|Outcome|HV (Specificity) Group|All subjects evaluated as healthy volunteer by consensus panel
1027934|NCT00750282|O1|Outcome|AD (Sensitivity) Group|All subjects evaluated as probable AD by consensus panel
1027935|NCT00750282|O2|Outcome|HV (Specificity) Group|All evaluated healthy volunteers
1027936|NCT00750282|O1|Outcome|AD (Sensitivity) Group|All evaluated subjects with Alzheimer's disease
1027937|NCT00750282|E4|Reported Event|Part B Alzheimer Patients|Florbetaben (BAY94-9172) : Healthy volunteers receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
1027981|NCT00750269|O1|Outcome|Level 5: 10.0 Gy/FX|SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy
1027938|NCT00750282|E3|Reported Event|Part B Healthy Volunteers|Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
1027939|NCT00750282|E2|Reported Event|Part A Alzheimer Patients|Florbetaben (BAY94-9172) : Healthy volunteers receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
1027940|NCT00750282|E1|Reported Event|Part A Healthy Volunteers|Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
1027941|NCT00750269|B6|Baseline|Total|Total of all reporting groups
1027942|NCT00750269|B5|Baseline|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy~SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
1027943|NCT00750269|B4|Baseline|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy~SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
1027944|NCT00750269|B3|Baseline|Level 7: 11.0 Gy/FX|"SBRT 55.0 Gy~SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy"
1027945|NCT00750269|B2|Baseline|Level 6: 10.5 Gy/FX|"SBRT 52.5 Gy~SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy"
1027946|NCT00750269|B1|Baseline|Level 5: 10.0 Gy/FX|"SBRT 50.0 Gy~SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy"
1027947|NCT00750269|P5|Participant Flow|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy~SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
1027948|NCT00750269|P4|Participant Flow|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy~SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
1027949|NCT00750269|P3|Participant Flow|Level 7: 11.0 Gy/FX|"SBRT 55.0 Gy~SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy"
1027950|NCT00750269|P2|Participant Flow|Level 6: 10.5 Gy/FX|"SBRT 52.5 Gy~SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy"
1027951|NCT00750269|P1|Participant Flow|Level 5: 10.0 Gy/FX|"SBRT 50.0 Gy~SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy"
1027952|NCT00750269|O5|Outcome|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy~SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
1027953|NCT00750269|O4|Outcome|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy~SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
1027954|NCT00750269|O3|Outcome|Level 7: 11.0 Gy/FX|"SBRT 55.0 Gy~SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy"
1027955|NCT00750269|O2|Outcome|Level 6: 10.5 Gy/FX|"SBRT 52.5 Gy~SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy"
1027956|NCT00750269|O1|Outcome|Level 5: 10.0 Gy/FX|"SBRT 50.0 Gy~SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy"
1027957|NCT00750269|O5|Outcome|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy~SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
1027958|NCT00750269|O4|Outcome|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy~SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
1027959|NCT00750269|O3|Outcome|Level 7: 11.0 Gy/FX|"SBRT 55.0 Gy~SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy"
1027960|NCT00750269|O2|Outcome|Level 6: 10.5 Gy/FX|"SBRT 52.5 Gy~SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy"
1027961|NCT00750269|O1|Outcome|Level 5: 10.0 Gy/FX|"SBRT 50.0 Gy~SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy"
1027962|NCT00750269|O5|Outcome|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy~SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
1027963|NCT00750269|O4|Outcome|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy~SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
1027964|NCT00750269|O3|Outcome|Level 7: 11.0 Gy/FX|SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy
1027965|NCT00750269|O2|Outcome|Level 6: 10.5 Gy/FX|SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
1027966|NCT00750269|O1|Outcome|Level 5: 10.0 Gy/FX|SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy
1027967|NCT00750269|O5|Outcome|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy~SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
1027968|NCT00750269|O4|Outcome|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy~SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
1027969|NCT00750269|O3|Outcome|Level 7: 11.0 Gy/FX|SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy
1027970|NCT00750269|O2|Outcome|Level 6: 10.5 Gy/FX|SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
1027971|NCT00750269|O1|Outcome|Level 5: 10.0 Gy/FX|SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy
1027972|NCT00750269|O5|Outcome|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy~SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
1027973|NCT00750269|O4|Outcome|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy~SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
1027974|NCT00750269|O3|Outcome|Level 7: 11.0 Gy/FX|SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy
1027975|NCT00750269|O2|Outcome|Level 6: 10.5 Gy/FX|SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
1027976|NCT00750269|O1|Outcome|Level 5: 10.0 Gy/FX|SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy
1027977|NCT00750269|O5|Outcome|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy~SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
1027978|NCT00750269|O4|Outcome|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy~SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
1027979|NCT00750269|O3|Outcome|Level 7: 11.0 Gy/FX|SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy
1027980|NCT00750269|O2|Outcome|Level 6: 10.5 Gy/FX|SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
1027982|NCT00750269|O5|Outcome|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy~SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
1027983|NCT00750269|O4|Outcome|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy~SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
1027984|NCT00750269|O3|Outcome|Level 7: 11.0 Gy/FX|SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy
1027985|NCT00750269|O2|Outcome|Level 6: 10.5 Gy/FX|SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
1027986|NCT00750269|O1|Outcome|Level 5: 10.0 Gy/FX|SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy
1027987|NCT00750269|O2|Outcome|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy~SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
1027988|NCT00750269|O1|Outcome|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy~SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
1027989|NCT00750269|O1|Outcome|All Participants|
1027990|NCT00750269|E5|Reported Event|Level 9: 12.0 Gy/FX|"SBRT 60.0 Gy~SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy"
1027991|NCT00750269|E4|Reported Event|Level 8: 11.5 Gy/FX|"SBRT 57.5 Gy~SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy"
1027992|NCT00750269|E3|Reported Event|Level 7: 11.0 Gy/FX|"SBRT 55.0 Gy~SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy"
1027993|NCT00750269|E2|Reported Event|Level 6: 10.5 Gy/FX|"SBRT 52.5 Gy~SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy"
1027994|NCT00750269|E1|Reported Event|Level 5: 10.0 Gy/FX|"SBRT 50.0 Gy~SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy"
1027995|NCT00750204|B3|Baseline|Total|Total of all reporting groups
1027996|NCT00750204|B2|Baseline|Conventional MV|"Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.~Conventional MV: Low tidal-volume mechanical ventilation"
1027997|NCT00750204|B1|Baseline|APRV|"Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.~APRV: APRV Protocol~Set FiO2 at 0.1 higher than the setting on conventional MV currently used~Tlow = 1.0 second (this setting shall remain unchanged throughout the trial).~Respiratory rate (RR) to equal 60-65% of RR on conventional MV.~Phigh = the inspiratory plateau pressure. Maximum Phigh = 30 cm H20.~Plow = 5 cm H2O. Adjust Plow to achieve pressure release volumes 5.5-6.5 ml/kg of PBW.~If release volumes on APRV are greater than desired, increase Plow by 2-4 cm H2O increments to a maximum of Plow = 12 cm H2O. If release volumes are larger than desired despite raising Plow to 12 cm H20, decrease Phigh in increments of 2-4 cm H20 to achieve desired release volumes (minimum Phigh = 12 cm H20). If release volumes on APRV still remain larger than desire"
1027998|NCT00750204|P2|Participant Flow|Conventional MV First|"Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.~Conventional MV: Low tidal-volume mechanical ventilation"
1027999|NCT00750204|P1|Participant Flow|Airway Pressure Release Ventilation (APRV) First|Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude Airway Pressure Release Ventilation •Set FiO2 at 0.1 higher than the setting on conventional MV currently used •Tlow = 1.0 second (this setting shall remain unchanged throughout the trial). •Respiratory rate (RR) to equal 60-65% of RR on conventional MV. •Phigh = the inspiratory plateau pressure. Maximum Phigh = 30 cm H20. •Plow = 5 cm H2O. Adjust Plow to achieve pressure release volumes 5.5-6.5 ml/kg of PBW. •If release volumes on APRV are greater than desired, increase Plow by 2-4 cm H2O increments to a maximum of Plow = 12 cm H2O. If release volumes are larger than desired despite raising Plow to 12 cm H20, decrease Phigh in increments of 2-4 cm H20 to achieve desired release volumes (min Phigh = 12 cm H20). If release volumes on APRV still remain larger than desire
1028000|NCT00750204|O2|Outcome|Conventional MV|"Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.~Conventional MV: Low tidal-volume mechanical ventilation"
1028001|NCT00750204|O1|Outcome|APRV|"Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.~APRV: APRV Protocol~Set FiO2 at 0.1 higher than the setting on conventional MV currently used~Tlow = 1.0 second (this setting shall remain unchanged throughout the trial).~Respiratory rate (RR) to equal 60-65% of RR on conventional MV.~Phigh = the inspiratory plateau pressure. Maximum Phigh = 30 cm H20.~Plow = 5 cm H2O. Adjust Plow to achieve pressure release volumes 5.5-6.5 ml/kg of PBW.~If release volumes on APRV are greater than desired, increase Plow by 2-4 cm H2O increments to a maximum of Plow = 12 cm H2O. If release volumes are larger than desired despite raising Plow to 12 cm H20, decrease Phigh in increments of 2-4 cm H20 to achieve desired release volumes (minimum Phigh = 12 cm H20). If release volumes on APRV still remain larger than desire"
1028002|NCT00750204|E2|Reported Event|Conventional MV|"Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.~Conventional MV: Low tidal-volume mechanical ventilation"
1028003|NCT00750204|E1|Reported Event|APRV|"Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude.~APRV: APRV Protocol~Set FiO2 at 0.1 higher than the setting on conventional MV currently used~Tlow = 1.0 second (this setting shall remain unchanged throughout the trial).~Respiratory rate (RR) to equal 60-65% of RR on conventional MV.~Phigh = the inspiratory plateau pressure. Maximum Phigh = 30 cm H20.~Plow = 5 cm H2O. Adjust Plow to achieve pressure release volumes 5.5-6.5 ml/kg of PBW.~If release volumes on APRV are greater than desired, increase Plow by 2-4 cm H2O increments to a maximum of Plow = 12 cm H2O. If release volumes are larger than desired despite raising Plow to 12 cm H20, decrease Phigh in increments of 2-4 cm H20 to achieve desired release volumes (minimum Phigh = 12 cm H20). If release volumes on APRV still remain larger than desire"
1028005|NCT00750191|B2|Baseline|Sham|"The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.~The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB."
1028006|NCT00750191|B1|Baseline|Intradiscal Biacuplasty|"Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.~After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure."
1028007|NCT00750191|P2|Participant Flow|Sham|"The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.~The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB."
1028008|NCT00750191|P1|Participant Flow|Intradiscal Biacuplasty|"Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.~After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure."
1028009|NCT00750191|O2|Outcome|Sham|"The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.~The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB."
1028010|NCT00750191|O1|Outcome|Intradiscal Biacuplasty|"Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.~After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure."
1028011|NCT00750191|O2|Outcome|Sham|"The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.~The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB."
1028012|NCT00750191|O1|Outcome|Intradiscal Biacuplasty|"Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.~After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure."
1028013|NCT00750191|O2|Outcome|Sham|"The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.~The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB."
1028014|NCT00750191|O1|Outcome|Intradiscal Biacuplasty|"Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.~After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure."
1028015|NCT00750191|O2|Outcome|Sham|"The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.~The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB."
1028060|NCT00750061|E2|Reported Event|Lithium Carbonate Tablet|"Lithium Carbonate: The subject start at a dosage regime of three times a day and one tablet of lithium carbonate, 250mg/table, oral administration each time for three days. The daily dose will be adjusted according to the serum lithium level and the clinical findings. Target serum lithium level is 0.6-1.2mM.~The course of medication is 6 weeks."
1028061|NCT00750061|E1|Reported Event|Placebo|Placebo: Matching placebo
1028016|NCT00750191|O1|Outcome|Intradiscal Biacuplasty|"Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.~After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure."
1028194|NCT00749671|O2|Outcome|ICD Testing Ramsey|"Ramsey Sedation Scale will be used to assess adequacy of moderate sedation during DFT~Ramsey Sedation Scale: The determination of the degree of sedation is accomplished using an established sedation scale."
1028017|NCT00750191|E2|Reported Event|Sham|"The same procedures will be followed as Group A (see above) except you will receive placebo (no treatment at all) during procedure.~The study will be unblinded at 6 months. If the patients in the IDB group show significant improvement compared to placebo they will be offered IDB."
1028018|NCT00750191|E1|Reported Event|Intradiscal Biacuplasty|"Two electrodes, located at the ends of two thin probes, are placed on both sides of the posterior annulus fibrosus of the intervertebral disc by inserting them through the skin to the intervertebral disc under x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature.~After the procedure, you will be asked to rest until the anesthesia wears off and then re-assessed for pain. Once you are awake and communicating with the physician conducting the procedure. Following completion of procedure you will be transferred to recovery and monitored for 45 minutes then discharged home with instructions. It is expected that you will limit your activities during the first week after the procedure."
1028019|NCT00750152|B3|Baseline|Total|Total of all reporting groups
1028020|NCT00750152|B2|Baseline|Placebo-2wks|Placebo cream applied daily for 2 weeks
1028021|NCT00750152|B1|Baseline|NAFT-500|Naftin 2% cream applied daily for 2 weeks
1028022|NCT00750152|P2|Participant Flow|Placebo-2wks|Placebo cream applied daily for 2 weeks
1028023|NCT00750152|P1|Participant Flow|NAFT-500|Naftin 2% cream applied daily for 2 weeks
1028024|NCT00750152|O2|Outcome|Placebo-2wks|Placebo cream applied daily for 2 weeks
1028025|NCT00750152|O1|Outcome|NAFT-500|Naftin 2% cream applied daily for 2 weeks
1028026|NCT00750152|O2|Outcome|Placebo-2wks|Placebo cream applied daily for 2 weeks
1028027|NCT00750152|O1|Outcome|NAFT-500|Naftin 2% cream applied daily for 2 weeks
1028028|NCT00750152|E2|Reported Event|Placebo-2wks|Placebo cream applied daily for 2 weeks
1028029|NCT00750152|E1|Reported Event|NAFT-500|Naftin 2% cream applied daily for 2 weeks
1028030|NCT00750139|B5|Baseline|Total|Total of all reporting groups
1028031|NCT00750139|B4|Baseline|Placebo 4-wks|Placebo cream applied daily for 4 weeks
1028032|NCT00750139|B3|Baseline|Naftin 1%|Naftin 1% active comparator applied daily for 4 weeks
1028033|NCT00750139|B2|Baseline|Placebo 2-wks|Placebo applied daily for 2-weeks
1028034|NCT00750139|B1|Baseline|NAFT-500|Naftin 2% Cream applied daily for 2 weeks
1028035|NCT00750139|P4|Participant Flow|Placebo 4-wks|Placebo cream applied daily for 4 weeks
1028036|NCT00750139|P3|Participant Flow|Naftin 1%|Naftin 1% active comparator applied daily for 4 weeks
1028037|NCT00750139|P2|Participant Flow|Placebo 2-wks|Placebo applied daily for 2-weeks
1028038|NCT00750139|P1|Participant Flow|NAFT-500|Naftin 2% Cream applied daily for 2 weeks
1028039|NCT00750139|O4|Outcome|Placebo 4-wks|Placebo cream applied daily for 4 weeks
1028040|NCT00750139|O3|Outcome|Naftin 1%|Naftin 1% active comparator applied daily for 4 weeks
1028041|NCT00750139|O2|Outcome|Placebo 2-wks|Placebo applied daily for 2-weeks
1028042|NCT00750139|O1|Outcome|NAFT-500|Naftin 2% Cream applied daily for 2 weeks
1028043|NCT00750139|O4|Outcome|Placebo 4-wks|Placebo control cream applied daily for 4 weeks
1028044|NCT00750139|O3|Outcome|Naftin 1%|Naftin 1% active comparator applied daily for 4 weeks
1028045|NCT00750139|O2|Outcome|Placebo 2-weeks|Placebo Control cream applied daily for 2-weeks
1028046|NCT00750139|O1|Outcome|NAFT-500|Naftin 2% Cream applied daily for 2 weeks
1028047|NCT00750139|E4|Reported Event|Placebo 4-wks|Placebo cream applied daily for 4 weeks
1028048|NCT00750139|E3|Reported Event|Naftin 1%|Naftin 1% active comparator applied daily for 4 weeks
1028049|NCT00750139|E2|Reported Event|Placebo 2-wks|Placebo applied daily for 2-weeks
1028050|NCT00750139|E1|Reported Event|NAFT-500|Naftin 2% Cream applied daily for 2 weeks
1028051|NCT00750061|B3|Baseline|Total|Total of all reporting groups
1028052|NCT00750061|B2|Baseline|Lithium Carbonate|"Lithium Carbonate~Lithium Carbonate: The subject start at a dosage regime of three times a day and one tablet of lithium carbonate, 250mg/table, oral administration each time for three days. The daily dose will be adjusted according to the serum lithium level and the clinical findings. Target serum lithium level is 0.6-1.2mM.~The course of medication is 6 weeks."
1028053|NCT00750061|B1|Baseline|Placebo|"Placebo~Placebo: Matching placebo"
1028054|NCT00750061|P2|Participant Flow|Lithium Carbonate Tablet|"Lithium Carbonate: The subject start at a dosage regime of three times a day and one tablet of lithium carbonate, 250mg/table, oral administration each time for three days. The daily dose will be adjusted according to the serum lithium level and the clinical findings. Target serum lithium level is 0.6-1.2mM.~The course of medication is 6 weeks."
1028055|NCT00750061|P1|Participant Flow|Placebo|Placebo: Matching placebo
1028056|NCT00750061|O2|Outcome|Lithium Carbonate|"Lithium Carbonate~Lithium Carbonate: The subject start at a dosage regime of three times a day and one tablet of lithium carbonate, 250mg/table, oral administration each time for three days. The daily dose will be adjusted according to the serum lithium level and the clinical findings. Target serum lithium level is 0.6-1.2mM.~The course of medication is 6 weeks."
1028057|NCT00750061|O1|Outcome|Placebo|"Placebo~Placebo: Matching placebo"
1028058|NCT00750061|O2|Outcome|Lithium Carbonate|"Lithium Carbonate~Lithium Carbonate: The subject start at a dosage regime of three times a day and one tablet of lithium carbonate, 250mg/table, oral administration each time for three days. The daily dose will be adjusted according to the serum lithium level and the clinical findings. Target serum lithium level is 0.6-1.2mM.~The course of medication is 6 weeks."
1028059|NCT00750061|O1|Outcome|Placebo|"Placebo~Placebo: Matching placebo"
1028062|NCT00749996|B3|Baseline|Total|Total of all reporting groups
1028063|NCT00749996|B2|Baseline|Control Group|"Single level herniectomy~Herniectomy: Herniectomy is defined as the removal of the extruded/protruded/sequestrated disc material. This is done by probing the annulus and disc space and removing all mobile disc fragments."
1028064|NCT00749996|B1|Baseline|Investigational Group|"Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System~DIAM™ Spinal Stabilization System: The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach."
1028301|NCT00749190|P1|Participant Flow|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
1028065|NCT00749996|P2|Participant Flow|Control Group|"Single level herniectomy~Herniectomy: Herniectomy is defined as the removal of the extruded/protruded/sequestrated disc material. This is done by probing the annulus and disc space and removing all mobile disc fragments."
1028066|NCT00749996|P1|Participant Flow|Investigational Group|"Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System~DIAM™ Spinal Stabilization System: The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach."
1028067|NCT00749996|O2|Outcome|Control Group|"Single level herniectomy~Herniectomy: Herniectomy is defined as the removal of the extruded/protruded/sequestrated disc material. This is done by probing the annulus and disc space and removing all mobile disc fragments."
1028068|NCT00749996|O1|Outcome|Investigational Group|"Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System~DIAM™ Spinal Stabilization System: The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach."
1028069|NCT00749996|O2|Outcome|Control Group|"Single level herniectomy~Herniectomy: Herniectomy is defined as the removal of the extruded/protruded/sequestrated disc material. This is done by probing the annulus and disc space and removing all mobile disc fragments."
1028070|NCT00749996|O1|Outcome|Investigational Group|"Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System~DIAM™ Spinal Stabilization System: The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach."
1028071|NCT00749996|E2|Reported Event|Control Group|"Single level herniectomy~Herniectomy: Herniectomy is defined as the removal of the extruded/protruded/sequestrated disc material. This is done by probing the annulus and disc space and removing all mobile disc fragments."
1028072|NCT00749996|E1|Reported Event|Investigational Group|"Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System~DIAM™ Spinal Stabilization System: The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach."
1028073|NCT00749957|B3|Baseline|Total|Total of all reporting groups
1028074|NCT00749957|B2|Baseline|Higher Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o treated with a higher dose of the rAAV2-CB-hRPE65 vector by subretinal injection
1028075|NCT00749957|B1|Baseline|Lower Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o treated with a lower dose of the rAAV2-CB-hRPE65 vector by subretinal injection
1028076|NCT00749957|P2|Participant Flow|Higher Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a higher dose of the rAAV2-CB-hRPE65 vector by subretinal injection
1028077|NCT00749957|P1|Participant Flow|Lower Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a lower dose of the rAAV2-CB-hRPE65 vector by subretinal injection
1028078|NCT00749957|O2|Outcome|Higher Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a higher dose of the rAAV2-CB-hRPE65 vector by subretinal injection
1028079|NCT00749957|O1|Outcome|Lower Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a lower dose of the rAAV2-CB-hRPE65 vector by subretinal injection
1028080|NCT00749957|O2|Outcome|Higher Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a higher dose of the rAAV2-CB-hRPE65 vector by subretinal injection
1028081|NCT00749957|O1|Outcome|Lower Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a lower dose of the rAAV2-CB-hRPE65 vector by subretinal injection
1028082|NCT00749957|O2|Outcome|Higher Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o treated with a higher dose of the rAAV2-CB-hRPE65 vector by subretinal injection
1028083|NCT00749957|O1|Outcome|Lower Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o treated with a lower dose of the rAAV2-CB-hRPE65 vector by subretinal injection
1028084|NCT00749957|E2|Reported Event|Higher Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a higher dose of the rAAV2-CB-hRPE65 vector by subretinal injection
1028085|NCT00749957|E1|Reported Event|Lower Dose of rAAV2-CB-hRPE65|Subjects at least 6 y/o administered a lower dose of the rAAV2-CB-hRPE65 vector by subretinal injection
1028086|NCT00749944|B3|Baseline|Total|Total of all reporting groups
1028087|NCT00749944|B2|Baseline|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1028088|NCT00749944|B1|Baseline|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028089|NCT00749944|P2|Participant Flow|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1028090|NCT00749944|P1|Participant Flow|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028091|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1028092|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028093|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1028295|NCT00749190|P7|Participant Flow|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
1028094|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028095|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1028302|NCT00749190|O5|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
1075901|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
1028096|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028097|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1028098|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028099|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1028100|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028101|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1028102|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028103|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1028104|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028105|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1028106|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028107|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1028108|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028109|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1028110|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028111|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1028112|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028113|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1028114|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028115|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1028116|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028117|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1028118|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028119|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1028120|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028121|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1028122|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028123|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1034363|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
1028124|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028125|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1028126|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028127|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1028128|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028129|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1028130|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028131|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1028132|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028133|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1028134|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028135|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1028136|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028137|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1028138|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028139|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1028140|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028141|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1028142|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028143|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1028144|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028145|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1028146|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028147|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1028148|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028149|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1028150|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028151|NCT00749944|O2|Outcome|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1028152|NCT00749944|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028153|NCT00749944|E2|Reported Event|Placebo|Placebo administered QD for the first 3 days followed by placebo administered BID for the remaining 11 weeks and 4 days (starting on Day 4)
1034364|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
1028154|NCT00749944|E1|Reported Event|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (starting on Day 8, the first day of Week 2)
1028155|NCT00749931|B3|Baseline|Total|Total of all reporting groups
1029150|NCT00746512|O2|Outcome|Placebo 15 mg|Prednisone 15 mg placebo tablets once daily for 15 days
1028156|NCT00749931|B2|Baseline|Device + (Standard of Care) SOC|"Use of the device in addition to the standard of care lumpectomy procedure.~MarginProbe: Device use to assess margin status of the excised specimen surface.~Lumpectomy: Standard of care lumpectomy procedure"
1028157|NCT00749931|B1|Baseline|Standard of Care (SOC)|"Standard of Care arm - standard of care lumpectomy procedure~Lumpectomy: Standard of care lumpectomy procedure"
1028158|NCT00749931|P3|Participant Flow|Roll-in|"Use of the device in addition to the standard of care lumpectomy procedure.~MarginProbe: Device use to assess margin status of the excised specimen surface.~Lumpectomy: Standard of care lumpectomy procedure"
1028159|NCT00749931|P2|Participant Flow|Device + (Standard of Care) SOC|"Use of the device in addition to the standard of care lumpectomy procedure.~MarginProbe: Device use to assess margin status of the excised specimen surface.~Lumpectomy: Standard of care lumpectomy procedure"
1028160|NCT00749931|P1|Participant Flow|Standard of Care (SOC)|"Standard of Care arm - standard of care lumpectomy procedure~Lumpectomy: Standard of care lumpectomy procedure"
1028161|NCT00749931|O2|Outcome|Device + (Standard of Care) SOC|"Use of the device in addition to the standard of care lumpectomy procedure.~MarginProbe: Device use to assess margin status of the excised specimen surface.~Lumpectomy: Standard of care lumpectomy procedure"
1028162|NCT00749931|O1|Outcome|Standard of Care (SOC)|"Standard of Care arm - standard of care lumpectomy procedure~Lumpectomy: Standard of care lumpectomy procedure"
1028163|NCT00749931|O2|Outcome|Device + (Standard of Care) SOC|"Use of the device in addition to the standard of care lumpectomy procedure.~MarginProbe: Device use to assess margin status of the excised specimen surface.~Lumpectomy: Standard of care lumpectomy procedure"
1028164|NCT00749931|O1|Outcome|Standard of Care (SOC)|"Standard of Care arm - standard of care lumpectomy procedure~Lumpectomy: Standard of care lumpectomy procedure"
1028165|NCT00749931|E3|Reported Event|Roll-in|"Use of the device in addition to the standard of care lumpectomy procedure.~MarginProbe: Device use to assess margin status of the excised specimen surface.~Lumpectomy: Standard of care lumpectomy procedure"
1028166|NCT00749931|E2|Reported Event|Device + (Standard of Care) SOC|"Use of the device in addition to the standard of care lumpectomy procedure.~MarginProbe: Device use to assess margin status of the excised specimen surface.~Lumpectomy: Standard of care lumpectomy procedure"
1028167|NCT00749931|E1|Reported Event|Standard of Care (SOC)|"Standard of Care arm - standard of care lumpectomy procedure~Lumpectomy: Standard of care lumpectomy procedure"
1028168|NCT00749775|B1|Baseline|Selara|Participants taking Selara according to Japanese Package Insert.
1028169|NCT00749775|P1|Participant Flow|Selara|Participants taking Selara according to Japanese Package Insert.
1028170|NCT00749775|O1|Outcome|Selara|Participants taking Selara according to Japanese Package Insert.
1028171|NCT00749775|O5|Outcome|At Last Evaluation Date|Mean diastolic blood pressure at last evaluation date among Participants taking Selara according to Japanese Package Insert.
1028172|NCT00749775|O4|Outcome|At 12 Weeks|Mean diastolic blood pressure at 12 weeks among Participants taking Selara according to Japanese Package Insert.
1028173|NCT00749775|O3|Outcome|At 8 Weeks|Mean diastolic blood pressure at 8 weeks among Participants taking Selara according to Japanese Package Insert.
1028174|NCT00749775|O2|Outcome|At 4 Weeks|Mean diastolic blood pressure at 4 weeks among Participants taking Selara according to Japanese Package Insert.
1028175|NCT00749775|O1|Outcome|At Baseline|Mean diastolic blood pressure at baseline among Participants taking Selara according to Japanese Package Insert.
1028176|NCT00749775|O5|Outcome|At Last Evaluation Date|Mean systolic blood pressure at last evaluation date among Participants taking Selara according to Japanese Package Insert.
1028177|NCT00749775|O4|Outcome|At 12 Weeks|Mean systolic blood pressure at 12 weeks among Participants taking Selara according to Japanese Package Insert.
1028178|NCT00749775|O3|Outcome|At 8 Weeks|Mean systolic blood pressure at 8 weeks among Participants taking Selara according to Japanese Package Insert.
1028179|NCT00749775|O2|Outcome|At 4 Weeks|Mean systolic blood pressure at 4 weeks among Participants taking Selara according to Japanese Package Insert.
1028180|NCT00749775|O1|Outcome|At Baseline|Mean systolic blood pressure at baseline among Participants taking Selara according to Japanese Package Insert.
1028181|NCT00749775|O1|Outcome|Selara|Participants taking Selara according to Japanese Package Insert.
1028182|NCT00749775|O1|Outcome|Selara|Participants taking Selara according to Japanese Package Insert.
1028183|NCT00749775|E1|Reported Event|Selara|Participants taking Selara according to Japanese Package Insert.
1028184|NCT00749684|B1|Baseline|Adults With Malignant Melanoma at High Risk of Relapse|"Adults with malignant melanoma of the following stages:~II and III (>/= 1.5 mm Breslow thickness without distant metastases~melanoma with lymph node metastases"
1028185|NCT00749684|P1|Participant Flow|Adults With Malignant Melanoma at High Risk of Relapse|"Adults with malignant melanoma of the following stages:~II and III (>/= 1.5 mm Breslow thickness without distant metastases~melanoma with lymph node metastases"
1028186|NCT00749684|O1|Outcome|Adults With Malignant Melanoma at High Risk of Relapse|"Adults with malignant melanoma of the following stages:~II and III (>/= 1.5 mm Breslow thickness without distant metastases~melanoma with lymph node metastases"
1028187|NCT00749684|O1|Outcome|Adults With Malignant Melanoma at High Risk of Relapse|"Adults with malignant melanoma of the following stages:~II and III (>/= 1.5 mm Breslow thickness without distant metastases~melanoma with lymph node metastases"
1028188|NCT00749684|E1|Reported Event|Interferon Alfa-2b|
1028189|NCT00749671|B3|Baseline|Total|Total of all reporting groups
1028190|NCT00749671|B2|Baseline|Nurse Administered Moderate Sedation|Moderate sedation using the Ramsey scale as assessed by a nurse trained and dedicated to monitoring the patient
1028191|NCT00749671|B1|Baseline|ICD Testingwith Bispectral Monitoring|"Bispectral Index Monitoring~Bispectral index monitoring using Aspect Monitor: The monitoring of the EEG signal is designed to determine if the sedation is adequate."
1028192|NCT00749671|P2|Participant Flow|Ramsey Scale Monitoring|Group assigned to sedation monitoring using the Ramsey Scale for ICD testing
1028193|NCT00749671|P1|Participant Flow|Bispectral Index Monitoring|Bispectral index monitoring using Aspect Monitor: The monitoring of the EEG signal is designed to determine if the sedation is adequate.
1028248|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
1028195|NCT00749671|O1|Outcome|ICD Testing BIS|"Bispectral Index Monitoring will be used to assess adequacy of moderate sedation during DFT.~Bispectral index monitoring: The monitoring of the EEG signal is designed to determine if the sedation is adequate."
1028196|NCT00749671|O2|Outcome|ICD testing2|"Ramsey Sedation Scale~Ramsey Sedation Scale: The determination of the degree of sedation is accomplished using an established sedation scale."
1028197|NCT00749671|O1|Outcome|ICD Testing|"Bispectral Index Monitoring~Bispectral index monitoring using Aspect Monitor: The monitoring of the EEG signal is designed to determine if the sedation is adequate."
1028198|NCT00749671|E2|Reported Event|Nurse Administered Moderate Sedation|Moderate sedation using the Ramsey scale as assessed by a nurse trained and dedicated to monitoring the patient
1028199|NCT00749671|E1|Reported Event|ICD Testingwith Bispectral Monitoring|"Bispectral Index Monitoring~Bispectral index monitoring using Aspect Monitor: The monitoring of the EEG signal is designed to determine if the sedation is adequate."
1028200|NCT00749580|B3|Baseline|Total|Total of all reporting groups
1028201|NCT00749580|B2|Baseline|2: Boosted PI+NRTIs|Group 2 Continue the same regimen without change
1028202|NCT00749580|B1|Baseline|1: Boosted PI+RAL|Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen
1028203|NCT00749580|P2|Participant Flow|Controlled|Group 2 Continue the same regimen without change
1028204|NCT00749580|P1|Participant Flow|Switched|Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen
1028205|NCT00749580|O2|Outcome|Boosted PI+NRTIs|Continue the same regimen without change
1028206|NCT00749580|O1|Outcome|Boosted PI+RAL|Switch NRTI backbone to RAL
1028207|NCT00749580|O2|Outcome|Boosted PI+NRTIs|Continue the same regimen without change
1028208|NCT00749580|O1|Outcome|Boosted PI+RAL|Switch NRTI backbone to RAL
1028209|NCT00749580|E2|Reported Event|Controlled|Group 2 Continue the same regimen without change
1028210|NCT00749580|E1|Reported Event|Switched|Group 1 Raltegravir 400 mg PO b.i.d. + their current boosted PI regimen
1028211|NCT00749476|B1|Baseline|BeneFIX|Plasma-derived FIX recovery with a dose of 50 ± 5 IU/kg before the conversion, BeneFIX recovery with a dose of 50 ± 5 IU/kg after the conversion, treatment with BeneFIX during the next 3 months.
1028212|NCT00749476|P1|Participant Flow|BeneFIX|Plasma-derived FIX recovery with a dose of 50 ± 5 IU/kg before the conversion, BeneFIX recovery with a dose of 50 ± 5 IU/kg after the conversion, treatment with BeneFIX during the next 3 months.
1028213|NCT00749476|O1|Outcome|BeneFIX|Plasma-derived FIX recovery with a dose of 50 ± 5 IU/kg before the conversion, BeneFIX recovery with a dose of 50 ± 5 IU/kg after the conversion, treatment with BeneFIX during the next 3 months.
1028214|NCT00749476|E1|Reported Event|BeneFIX|Plasma-derived FIX recovery with a dose of 50 ± 5 IU/kg before the conversion, BeneFIX recovery with a dose of 50 ± 5 IU/kg after the conversion, treatment with BeneFIX during the next 3 months.
1028215|NCT00749463|B4|Baseline|Total|Total of all reporting groups
1028216|NCT00749463|B3|Baseline|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
1028217|NCT00749463|B2|Baseline|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
1028218|NCT00749463|B1|Baseline|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
1028219|NCT00749463|P3|Participant Flow|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
1028220|NCT00749463|P2|Participant Flow|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
1028221|NCT00749463|P1|Participant Flow|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
1028222|NCT00749463|O3|Outcome|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
1028223|NCT00749463|O2|Outcome|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
1028224|NCT00749463|O1|Outcome|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
1028225|NCT00749463|O3|Outcome|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
1028226|NCT00749463|O2|Outcome|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
1028227|NCT00749463|O1|Outcome|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
1028228|NCT00749463|O3|Outcome|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
1028229|NCT00749463|O2|Outcome|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
1028230|NCT00749463|O1|Outcome|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
1028231|NCT00749463|O3|Outcome|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
1028232|NCT00749463|O2|Outcome|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
1028233|NCT00749463|O1|Outcome|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
1028234|NCT00749463|O3|Outcome|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
1028235|NCT00749463|O2|Outcome|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
1028236|NCT00749463|O1|Outcome|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
1028237|NCT00749463|O3|Outcome|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
1028238|NCT00749463|O2|Outcome|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
1028239|NCT00749463|O1|Outcome|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
1028240|NCT00749463|O3|Outcome|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
1028241|NCT00749463|O2|Outcome|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
1028242|NCT00749463|O1|Outcome|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
1028243|NCT00749463|E3|Reported Event|Nicotine Patch|Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
1028244|NCT00749463|E2|Reported Event|Nicotine Gum 4|Dosage: 4 mg, Dosage Form: Gum
1028245|NCT00749463|E1|Reported Event|Nicotine Gum 2|Dosage: 2 mg, Dosage Form: Gum
1028826|NCT00747149|B2|Baseline|Rosuvastatin 20 mg (Initial)|20 mg RSV as initial dose
1028246|NCT00749398|B1|Baseline|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
1028247|NCT00749398|P1|Participant Flow|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
1028249|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
1028250|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
1028251|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
1028252|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
1028253|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
1028254|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
1028255|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
1028256|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
1028257|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
1028258|NCT00749398|O1|Outcome|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
1028259|NCT00749398|E1|Reported Event|Infliximab|Participants with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label were asked to participate in this observational study.
1028260|NCT00749268|B5|Baseline|Total|Total of all reporting groups
1028261|NCT00749268|B4|Baseline|Ventral Arm - ProTack|Ventral hernia study arm with ProTack as treatment.
1028262|NCT00749268|B3|Baseline|Ventral Arm - Absorbatack|Ventral hernia study arm with AbsorbaTack as treatment.
1028263|NCT00749268|B2|Baseline|Inguinal Arm - ProTack|Inguinal hernia study arm with ProTack as treatment.
1028264|NCT00749268|B1|Baseline|Inguinal Arm - AbsorbaTack|Inguinal hernia study arm with AbsorbaTack as treatment.
1028265|NCT00749268|P2|Participant Flow|Ventral Arm|Patients with ventral hernias are randomized to receive either AbsorbaTack or ProTack. The two treatments are compared within a single hernia type but not across hernia types.
1028266|NCT00749268|P1|Participant Flow|Inguinal Arm|Patients with inguinal hernias are randomized to receive either AbsorbaTack or ProTack. The two treatments are compared within a single hernia type but not across hernia types.
1028267|NCT00749268|O4|Outcome|Ventral Arm - ProTack|
1028268|NCT00749268|O3|Outcome|Ventral Arm - Absorbatack|
1028269|NCT00749268|O2|Outcome|Inguinal Arm - ProTack|Inguinal hernia study arm with ProTack as treatment.
1028270|NCT00749268|O1|Outcome|Inguinal Arm - AbsorbaTack|Inguinal hernia study arm with AbsorbaTack as treatment.
1028271|NCT00749268|O4|Outcome|Ventral Arm - ProTack|
1028272|NCT00749268|O3|Outcome|Ventral Arm - Absorbatack|
1028273|NCT00749268|O2|Outcome|Inguinal Arm - ProTack|Inguinal hernia study arm with ProTack as treatment.
1028274|NCT00749268|O1|Outcome|Inguinal Arm - AbsorbaTack|Inguinal hernia study arm with AbsorbaTack as treatment.
1028275|NCT00749268|O4|Outcome|Ventral Arm - ProTack|
1028276|NCT00749268|O3|Outcome|Ventral Arm - Absorbatack|
1028277|NCT00749268|O2|Outcome|Inguinal Arm - ProTack|Inguinal hernia study arm with ProTack as treatment.
1028278|NCT00749268|O1|Outcome|Inguinal Arm - AbsorbaTack|Inguinal hernia study arm with AbsorbaTack as treatment.
1028279|NCT00749268|O4|Outcome|Ventral Arm - ProTack|
1028280|NCT00749268|O3|Outcome|Ventral Arm - Absorbatack|
1028281|NCT00749268|O2|Outcome|Inguinal Arm - ProTack|Inguinal hernia study arm with ProTack as treatment.
1028282|NCT00749268|O1|Outcome|Inguinal Arm - AbsorbaTack|Inguinal hernia study arm with AbsorbaTack as treatment.
1028283|NCT00749268|E4|Reported Event|Ventral Arm - ProTack|Ventral hernia study arm with ProTack as treatment.
1028284|NCT00749268|E3|Reported Event|Ventral Arm - Absorbatack|Ventral hernia study arm with AbsorbaTack as treatment.
1028285|NCT00749268|E2|Reported Event|Inguinal Arm - ProTack|Inguinal hernia study arm with ProTack as treatment.
1028286|NCT00749268|E1|Reported Event|Inguinal Arm - AbsorbaTack|Inguinal hernia study arm with AbsorbaTack as treatment.
1028287|NCT00749190|B8|Baseline|Total|Total of all reporting groups
1028288|NCT00749190|B7|Baseline|Sitag|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
1028289|NCT00749190|B6|Baseline|Empa 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
1028290|NCT00749190|B5|Baseline|Empa 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
1028291|NCT00749190|B4|Baseline|Empa 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
1028292|NCT00749190|B3|Baseline|Empa 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
1028293|NCT00749190|B2|Baseline|Empa 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
1028294|NCT00749190|B1|Baseline|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
1028296|NCT00749190|P6|Participant Flow|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
1028297|NCT00749190|P5|Participant Flow|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
1028298|NCT00749190|P4|Participant Flow|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
1028299|NCT00749190|P3|Participant Flow|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
1028300|NCT00749190|P2|Participant Flow|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
1075902|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
1028303|NCT00749190|O4|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
1028304|NCT00749190|O3|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
1028305|NCT00749190|O2|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
1028306|NCT00749190|O1|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
1028307|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
1028308|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
1028309|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
1028310|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
1028311|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
1028312|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
1028313|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
1028314|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
1028315|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
1028316|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
1028317|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
1028318|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
1028319|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
1028320|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
1028321|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
1028322|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
1028323|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
1028324|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
1028325|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
1028326|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
1028327|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
1028328|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
1028329|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
1028330|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
1028331|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
1028332|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
1028333|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
1028334|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
1028335|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
1028336|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
1028337|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
1028338|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
1028339|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
1028340|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
1028341|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
1028342|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
1028343|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
1028344|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
1028345|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
1028346|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
1028347|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
1028348|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
1028349|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
1028350|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
1028351|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
1028352|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
1028353|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
1028354|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
1028355|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
1028356|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
1028357|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
1028358|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
1028359|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
1028360|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
1028361|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
1028362|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
1028363|NCT00749190|O7|Outcome|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
1028364|NCT00749190|O6|Outcome|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
1028365|NCT00749190|O5|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
1028366|NCT00749190|O4|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
1028367|NCT00749190|O3|Outcome|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
1028368|NCT00749190|O2|Outcome|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
1028369|NCT00749190|O1|Outcome|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
1028370|NCT00749190|E7|Reported Event|Sitagliptin OL|Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
1028371|NCT00749190|E6|Reported Event|Empagliflozin 50 mg|Patients receive 50 mg Empagliflozin in tablets once daily.
1028372|NCT00749190|E5|Reported Event|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
1028373|NCT00749190|E4|Reported Event|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
1028374|NCT00749190|E3|Reported Event|Empagliflozin 5 mg|Patients receive 5 mg Empagliflozin in tablets once daily.
1028375|NCT00749190|E2|Reported Event|Empagliflozin 1 mg|Patients receive 1 mg Empagliflozin in tablets once daily.
1028376|NCT00749190|E1|Reported Event|Placebo|Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
1028377|NCT00749073|B1|Baseline|Mild Percutaneous Lumbar Decompression|The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression.
1028378|NCT00749073|P1|Participant Flow|Mild Percutaneous Lumbar Decompression|The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression.
1028379|NCT00749073|O1|Outcome|Mild Percutaneous Lumbar Decompression|The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression.
1028380|NCT00749073|O1|Outcome|Mild Percutaneous Lumbar Decompression|The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression. The mean change and standard deviation between baseline (pretreatment) and Month 6 are reported, where a positive value represents the baseline value minus the 6 month value.
1028381|NCT00749073|O1|Outcome|Mild Percutaneous Lumbar Decompression|The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression.
1028382|NCT00749073|E1|Reported Event|Mild Percutaneous Lumbar Decompression|The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression.
1028383|NCT00748982|B3|Baseline|Total|Total of all reporting groups
1028384|NCT00748982|B2|Baseline|Placebo Dose 1 and Dose 2|Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
1028385|NCT00748982|B1|Baseline|AZD1305 Dose 1 and Dose 2|AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
1028386|NCT00748982|P2|Participant Flow|Placebo Dose 1 and Dose 2|Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
1028387|NCT00748982|P1|Participant Flow|AZD1305 Dose 1 and Dose 2|AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
1028388|NCT00748982|O2|Outcome|Placebo Dose 1 and Dose 2|Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
1028389|NCT00748982|O1|Outcome|AZD1305 Dose 1 and Dose 2|AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
1028390|NCT00748982|O2|Outcome|Placebo Dose 1 and Dose 2|Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
1028391|NCT00748982|O1|Outcome|AZD1305 Dose 1 and Dose 2|AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
1028392|NCT00748982|O2|Outcome|Placebo Dose 1 and Dose 2|Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
1028393|NCT00748982|O1|Outcome|AZD1305 Dose 1 and Dose 2|AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
1028394|NCT00748982|O2|Outcome|Placebo Dose 1 and Dose 2|Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
1028395|NCT00748982|O1|Outcome|AZD1305 Dose 1 and Dose 2|AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
1028396|NCT00748982|E2|Reported Event|Placebo Dose 1 and Dose 2|Sodium chloride was given as an initial iv loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
1028397|NCT00748982|E1|Reported Event|AZD1305 Dose 1 and Dose 2|AZD1305 was given as an initial intravenous (iv) loading dose during 30 min followed by a maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out. The mean total dose of AZD1305 was 30 mg (range 29-31 mg)
1028398|NCT00748969|B3|Baseline|Total|Total of all reporting groups
1028399|NCT00748969|B2|Baseline|No Growth Hormone Treatment in Year 1|No growth hormone treatment in year 1; option for treatment in year 2 open-label period.
1028400|NCT00748969|B1|Baseline|Growth Hormone Treatmen|"Growth hormone treatment arm. Somatropin (DNA origin)~Somatropin (DNA origin): The study starting dose of Nutropin AQ® will be 0.48 mg/kg/week divided into daily SC injections. Nutropin AQ® will be administered by either the subject or, if unable to demonstrate competency in this, then by the guardian. To decrease the risk of increased intracranial hypertension, the dose in the first month of treatment will be decreased by 50% (0.24 mg/kg/week), and then increased to 0.48 mg/kg/week if tolerated well after 1 month."
1028401|NCT00748969|P2|Participant Flow|No Growth Hormone Treatment in Year 1|No growth hormone treatment in year 1; option for treatment in year 2 open-label period.
1028402|NCT00748969|P1|Participant Flow|Growth Hormone Treatmen|"Growth hormone treatment arm. Somatropin (DNA origin)~Somatropin (DNA origin): The study starting dose of Nutropin AQ® will be 0.48 mg/kg/week divided into daily SC injections. Nutropin AQ® will be administered by either the subject or, if unable to demonstrate competency in this, then by the guardian. To decrease the risk of increased intracranial hypertension, the dose in the first month of treatment will be decreased by 50% (0.24 mg/kg/week), and then increased to 0.48 mg/kg/week if tolerated well after 1 month."
1028403|NCT00748969|O2|Outcome|No Growth Hormone Treatment|Observation only: no growth hormone treatment and no placebo.
1028404|NCT00748969|O1|Outcome|Growth Hormone Treatment|"Growth hormone treatment arm. Somatropin (DNA origin)~Somatropin (DNA origin): The study starting dose of Nutropin AQ® will be 0.48 mg/kg/week divided into daily SC injections. Nutropin AQ® will be administered by either the subject or, if unable to demonstrate competency in this, then by the guardian. To decrease the risk of increased intracranial hypertension, the dose in the first month of treatment will be decreased by 50% (0.24 mg/kg/week), and then increased to 0.48 mg/kg/week if tolerated well after 1 month."
1028405|NCT00748969|E2|Reported Event|No GH Treatment|No placebo/no treatment
1028406|NCT00748969|E1|Reported Event|GH Treatment|"Growth hormone treatment arm. Somatropin (DNA origin)~Somatropin (DNA origin): The study starting dose of Nutropin AQ® will be 0.48 mg/kg/week divided into daily SC injections. Nutropin AQ® will be administered by either the subject or, if unable to demonstrate competency in this, then by the guardian. To decrease the risk of increased intracranial hypertension, the dose in the first month of treatment will be decreased by 50% (0.24 mg/kg/week), and then increased to 0.48 mg/kg/week if tolerated well after 1 month."
1028407|NCT00748956|B4|Baseline|Total|Total of all reporting groups
1028408|NCT00748956|B3|Baseline|Placebo|"Placebo comparator~Placebo: placebo comparator (0nmol)) administered intranasally"
1028409|NCT00748956|B2|Baseline|High Dose NPY|"High Dose, Receive 100 nmol dose of NPY~High dose NPY: 100nmol administered intranasally"
1028410|NCT00748956|B1|Baseline|Low Dose NPY|"Low dose, Receive 50 nmol dose of NPY~Low dose NPY: 50nmol, administered intranasally"
1028411|NCT00748956|P3|Participant Flow|Placebo|"Placebo comparator~Placebo: placebo comparator (0nmol)) administered intranasally"
1028412|NCT00748956|P2|Participant Flow|High Dose NPY|"High Dose, Receive 100 nmol dose of NPY~High dose NPY: 100nmol administered intranasally"
1028413|NCT00748956|P1|Participant Flow|Low Dose NPY|"Low dose, Receive 50 nmol dose of NPY~Low dose NPY: 50nmol, administered intranasally"
1028414|NCT00748956|O3|Outcome|Placebo|"Placebo comparator~Placebo: placebo comparator (0nmol)) administered intranasally"
1028415|NCT00748956|O2|Outcome|High Dose NPY|"High Dose, Receive 100 nmol dose of NPY~High dose NPY: 100nmol administered intranasally"
1028416|NCT00748956|O1|Outcome|Low Dose NPY|"Low dose, Receive 50 nmol dose of NPY~Low dose NPY: 50nmol, administered intranasally"
1028417|NCT00748956|O3|Outcome|Placebo|"Placebo comparator~Placebo: placebo comparator (0nmol)) administered intranasally"
1028418|NCT00748956|O2|Outcome|High Dose NPY|"High Dose, Receive 100 nmol dose of NPY~High dose NPY: 100nmol administered intranasally"
1028419|NCT00748956|O1|Outcome|Low Dose NPY|"Low dose, Receive 50 nmol dose of NPY~Low dose NPY: 50nmol, administered intranasally"
1028420|NCT00748956|O3|Outcome|Placebo|"Placebo comparator~Placebo: placebo comparator (0nmol)) administered intranasally"
1028421|NCT00748956|O2|Outcome|High Dose NPY|"High Dose, Receive 100 nmol dose of NPY~High dose NPY: 100nmol administered intranasally"
1028422|NCT00748956|O1|Outcome|Low Dose NPY|"Low dose, Receive 50 nmol dose of NPY~Low dose NPY: 50nmol, administered intranasally"
1034365|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
1028423|NCT00748956|O3|Outcome|Placebo|"Placebo comparator~Placebo: placebo comparator (0nmol)) administered intranasally"
1028424|NCT00748956|O2|Outcome|High Dose NPY|"High Dose, Receive 100 nmol dose of NPY~High dose NPY: 100nmol administered intranasally"
1028425|NCT00748956|O1|Outcome|Low Dose NPY|"Low dose, Receive 50 nmol dose of NPY~Low dose NPY: 50nmol, administered intranasally"
1028426|NCT00748956|O3|Outcome|Placebo|"Placebo comparator~Placebo: placebo comparator (0nmol)) administered intranasally"
1028427|NCT00748956|O2|Outcome|High Dose NPY|"High Dose, Receive 100 nmol dose of NPY~High dose NPY: 100nmol administered intranasally"
1028428|NCT00748956|O1|Outcome|Low Dose NPY|"Low dose, Receive 50 nmol dose of NPY~Low dose NPY: 50nmol, administered intranasally"
1029151|NCT00746512|O1|Outcome|Prednisone 15 mg|Prednisone 15 mg tablets once daily for 15 days
1028429|NCT00748956|O3|Outcome|Placebo|"Placebo comparator~Placebo: placebo comparator (0nmol)) administered intranasally"
1028430|NCT00748956|O2|Outcome|High Dose NPY|"High Dose, Receive 100 nmol dose of NPY~High dose NPY: 100nmol administered intranasally"
1028431|NCT00748956|O1|Outcome|Low Dose NPY|"Low dose, Receive 50 nmol dose of NPY~Low dose NPY: 50nmol, administered intranasally"
1028432|NCT00748956|E3|Reported Event|Placebo|"Placebo comparator~Placebo: placebo comparator (0nmol)) administered intranasally"
1028433|NCT00748956|E2|Reported Event|High Dose NPY|"High Dose, Receive 100 nmol dose of NPY~High dose NPY: 100nmol administered intranasally"
1028434|NCT00748956|E1|Reported Event|Low Dose NPY|"Low dose, Receive 50 nmol dose of NPY~Low dose NPY: 50nmol, administered intranasally"
1028435|NCT00748865|B1|Baseline|Overall Study|
1028436|NCT00748865|P2|Participant Flow|Systane Drops, Then Systane Ultra Drops|Patients first received Systane Drops, then received Systane Ultra Drops
1028437|NCT00748865|P1|Participant Flow|Systane Ultra Drops, Then Systane Drops|Patients received Systane Ultra Drops first, then received Systane Drops.
1028438|NCT00748865|O2|Outcome|Systane|Systane
1028439|NCT00748865|O1|Outcome|Systane Ultra|Systane Ultra
1028440|NCT00748865|E2|Reported Event|Systane|Systane
1028441|NCT00748865|E1|Reported Event|Systane Ultra|Systane Ultra
1028442|NCT00748826|B1|Baseline|Infliximab|Patients with active rheumatoid arthritis (RA) confirmed with ACR criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of Infliximab therapy with additional infusions of 5 mg/kg at week 2
1028443|NCT00748826|P1|Participant Flow|Infliximab|Patients with active rheumatoid arthritis (RA) confirmed with ACR criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of Infliximab therapy with additional infusions of 5 mg/kg at week 2
1028444|NCT00748826|O1|Outcome|Infliximab|Patients with active rheumatoid arthritis (RA) confirmed with ACR criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of Infliximab therapy with additional infusions of 5 mg/kg at week 2
1028445|NCT00748826|O1|Outcome|Infliximab|Patients with active rheumatoid arthritis (RA) confirmed with ACR criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of Infliximab therapy with additional infusions of 5 mg/kg at week 2
1028446|NCT00748826|O1|Outcome|Infliximab|Patients with active rheumatoid arthritis (RA) confirmed with ACR criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of Infliximab therapy with additional infusions of 5 mg/kg at week 2
1028447|NCT00748826|O1|Outcome|Infliximab|Patients with active rheumatoid arthritis (RA) confirmed with ACR criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of Infliximab therapy with additional infusions of 5 mg/kg at week 2
1028448|NCT00748826|E1|Reported Event|Infliximab|Patients with active rheumatoid arthritis (RA) confirmed with ACR criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of Infliximab therapy with additional infusions of 5 mg/kg at week 2
1028449|NCT00748709|B1|Baseline|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
1028450|NCT00748709|P1|Participant Flow|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
1028451|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
1028452|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
1028453|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
1028454|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
1028455|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
1028456|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
1028457|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
1028458|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
1028459|NCT00748709|O1|Outcome|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
1028460|NCT00748709|E1|Reported Event|Afatinib 50mg|Patients with genetically pre-screened cancers with EGFR and/or HER2 gene amplification or EGFR activating mutations treated with afatinib 50mg once daily.
1028461|NCT00748657|B1|Baseline|Bevacizumab|Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
1028462|NCT00748657|P1|Participant Flow|Bevacizumab|Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
1028463|NCT00748657|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
1028464|NCT00748657|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
1028465|NCT00748657|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
1028466|NCT00748657|E1|Reported Event|Bevacizumab|Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
1028467|NCT00748579|B3|Baseline|Total|Total of all reporting groups
1028468|NCT00748579|B2|Baseline|High Dose CK-1827452 (Cohort 2)|≤ 1.0 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
1028469|NCT00748579|B1|Baseline|Mid Dose CK-1827452 (Cohort 1)|0.5 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
1028470|NCT00748579|P2|Participant Flow|High Dose CK-1827452 (Cohort 2)|≤ 1.0 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
1028471|NCT00748579|P1|Participant Flow|Mid Dose CK-1827452 (Cohort 1)|0.5 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
1028472|NCT00748579|O2|Outcome|High Dose CK-1827452 (Cohort 2)|≤ 1.0 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
1028473|NCT00748579|O1|Outcome|Mid Dose CK-1827452 (Cohort 1)|0.5 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
1028474|NCT00748579|E2|Reported Event|High Dose CK-1827452 (Cohort 2)|≤ 1.0 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
1028475|NCT00748579|E1|Reported Event|Mid Dose CK-1827452 (Cohort 1)|0.5 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
1028476|NCT00748566|B1|Baseline|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
1028477|NCT00748566|P1|Participant Flow|Ziprasidone|Ziprasidone 40 milligram (mg) capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
1028478|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
1028479|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
1028480|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
1028481|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
1028482|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
1028483|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
1028484|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
1028485|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
1028827|NCT00747149|B1|Baseline|Rosuvastatin 10 mg (Initial)|10 mg rosuvastatin (RSV) as initial dose
1028486|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
1028487|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
1028576|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
1028488|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
1028489|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
1028490|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
1028491|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
1028492|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
1028493|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
1028494|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
1028495|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
1028496|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
1028497|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
1028498|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
1028499|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
1028500|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
1028501|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
1028502|NCT00748566|O1|Outcome|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
1028503|NCT00748566|E1|Reported Event|Ziprasidone|Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator’s discretion from Day 16 to 365.
1028504|NCT00748241|B1|Baseline|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
1028505|NCT00748241|P1|Participant Flow|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
1028506|NCT00748241|O1|Outcome|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
1028507|NCT00748241|O1|Outcome|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
1028508|NCT00748241|O1|Outcome|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
1028509|NCT00748241|O1|Outcome|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
1028510|NCT00748241|O1|Outcome|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
1028511|NCT00748241|E1|Reported Event|Astra Tech Fixture ST|Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
1028512|NCT00748189|B3|Baseline|Total|Total of all reporting groups
1028577|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
1028578|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
1075903|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
1028513|NCT00748189|B2|Baseline|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028514|NCT00748189|B1|Baseline|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028515|NCT00748189|P2|Participant Flow|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028516|NCT00748189|P1|Participant Flow|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028517|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028518|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028519|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028520|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028521|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028522|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028523|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028524|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028525|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028526|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028527|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028528|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028529|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028530|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028531|NCT00748189|O2|Outcome|Study LEUA1001: Chlorambucil|Participants with CLL, Non-Hodgkin’s lymphoma or other refractory malignancies received three different formulations of a 0.2 mg/kilogram(kg) chlorambucil tablet orally with a two-day interval between drug administration.
1028574|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
1034366|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
1028579|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
1028580|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
1028581|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period.
1028532|NCT00748189|O1|Outcome|Study OMB110911: Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028533|NCT00748189|O2|Outcome|Study LEUA1001: Chlorambucil|Participants with CLL, Non-Hodgkin’s lymphoma or other refractory malignancies received three different formulations of a 0.2 mg/kilogram(kg) chlorambucil tablet orally with a two-day interval between drug administration.
1028534|NCT00748189|O1|Outcome|Study OMB110911: Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028535|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle up to 12 cycles in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
1028536|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
1028537|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle up to 12 cycles in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
1028538|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
1028539|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle up to 12 cycles in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
1028540|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
1028541|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle up to 12 cycles in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
1028542|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
1028543|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle up to 12 cycles in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
1028544|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for up to 12 cycles.
1028545|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028546|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028547|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028548|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028549|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028550|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028551|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028552|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028575|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period.
1028553|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028554|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028555|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028556|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028557|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028558|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028559|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028560|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028561|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028562|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028563|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028564|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028565|NCT00748189|O2|Outcome|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028566|NCT00748189|O1|Outcome|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028567|NCT00748189|E2|Reported Event|Ofatumumab + Chlorambucil|Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028568|NCT00748189|E1|Reported Event|Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles.
1028569|NCT00748098|B1|Baseline|All Participants in the Intent-to-Treat (ITT) Population|All randomized participants who took at least one dose of study drug and had at least one post-baseline polysomnography (PSG) efficacy assessment
1028570|NCT00748098|P2|Participant Flow|GEn 1200 mg/Day Followed by Placebo|Participants randomized to GEn 1200 mg/day administered once daily with food at 5 pm during the 28-day First Treatment Intervention Period (Days 1-3, 600 mg). GEn 600 mg administered once daily with food at 5 pm during the 7-day First Taper Period. No treatment was given during 7-day Washout. Matching placebo administered once daily with food at 5 pm during the 28-day Second Treatment Intervention Period and the 7-day Second Taper Period. No treatment was given during Follow-up.
1028571|NCT00748098|P1|Participant Flow|Placebo Followed by GEn 1200 mg/Day|Participants randomized to matching placebo administered once daily with food at 5 pm during the 28-day First Treatment Intervention Period and the 7-day First Taper Period. No treatment was given during the 7-day Washout. Gabapentin enacarbil (GEn) 1200 mg/day administered once daily with food at 5 pm during the 28-day Second Treatment Intervention Period (Days 1-3, 600 mg). GEn 600 mg administered once daily with food at 5 pm during the 7-day Second Taper Period. No treatment was given during Follow-up.
1028572|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
1028573|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
1028582|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
1028583|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
1028584|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
1028585|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
1028586|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
1028587|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
1028588|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
1028589|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
1028590|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
1028591|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
1028592|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
1028593|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
1028594|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
1028595|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
1028596|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
1028597|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
1028598|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
1028599|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
1028600|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
1028601|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period.
1028602|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
1028603|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
1028604|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
1028605|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
1028606|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
1028607|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
1028608|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
1028609|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
1028610|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
1028611|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
1028612|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
1028613|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
1028614|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
1028615|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
1028616|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
1028617|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
1028618|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
1028619|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
1028620|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
1028621|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
1028622|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
1028623|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
1028624|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
1028625|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
1028626|NCT00748098|O2|Outcome|GEn 1200 mg|GEn 1200 mg once daily either in first intervention period or second intervention period
1028627|NCT00748098|O1|Outcome|Placebo|Placebo once daily either in first intervention period or second intervention period
1028750|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
1028628|NCT00748098|E2|Reported Event|GEn 1200 mg|Participants who took at least one dose of GEn 1200 mg in either the first intervention period or the second intervention period. Of the 136 participants in the Safety Population, 127 took at least one dose of GEn 1200 mg.
1028629|NCT00748098|E1|Reported Event|Placebo|Participants who took at least one dose of placebo in either the first intervention period or the second intervention period. Of the 136 participants in the Safety Population, 132 took at least one dose of placebo.
1028657|NCT00747812|O1|Outcome|Active Stimulation (Treatment Group)|Active stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
1075904|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
1028630|NCT00748085|B1|Baseline|1-all Subjects|CryoSpray Ablation (TM) System: Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment at Day 0. Subjects will undergo repeat bronchoscopy in the first seven days after the initial treatment to check for mucosal sloughing and to reassess luminal patency of the airway. Subjects may undergo up to one bronchoscopy with CSA therapy every seven days for a total of four (4) treatments in the first month. If they present with symptoms thereafter, then a repeat bronchoscopy will be performed; if luminal obstruction is noted, then the subject will begin the treatment protocol again. Subjects may also have rigid/flexible bronchoscopy with laser or electrocautery snare for debulking of tumors. If disease exists bilaterally, only one side will be sprayed initially.
1028631|NCT00748085|P1|Participant Flow|1-all Subjects|CryoSpray Ablation (TM) System: Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment at Day 0. Subjects will undergo repeat bronchoscopy in the first seven days after the initial treatment to check for mucosal sloughing and to reassess luminal patency of the airway. Subjects may undergo up to one bronchoscopy with CSA therapy every seven days for a total of four (4) treatments in the first month. If they present with symptoms thereafter, then a repeat bronchoscopy will be performed; if luminal obstruction is noted, then the subject will begin the treatment protocol again. Subjects may also have rigid/flexible bronchoscopy with laser or electrocautery snare for debulking of tumors. If disease exists bilaterally, only one side will be sprayed initially.
1028632|NCT00748085|O1|Outcome|1-all Subjects|CryoSpray Ablation (TM) System: Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment at Day 0. Subjects will undergo repeat bronchoscopy in the first seven days after the initial treatment to check for mucosal sloughing and to reassess luminal patency of the airway. Subjects may undergo up to one bronchoscopy with CSA therapy every seven days for a total of four (4) treatments in the first month. If they present with symptoms thereafter, then a repeat bronchoscopy will be performed; if luminal obstruction is noted, then the subject will begin the treatment protocol again. Subjects may also have rigid/flexible bronchoscopy with laser or electrocautery snare for debulking of tumors. If disease exists bilaterally, only one side will be sprayed initially.
1028633|NCT00748085|O1|Outcome|1-all Subjects|CryoSpray Ablation (TM) System: Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment at Day 0. Subjects will undergo repeat bronchoscopy in the first seven days after the initial treatment to check for mucosal sloughing and to reassess luminal patency of the airway. Subjects may undergo up to one bronchoscopy with CSA therapy every seven days for a total of four (4) treatments in the first month. If they present with symptoms thereafter, then a repeat bronchoscopy will be performed; if luminal obstruction is noted, then the subject will begin the treatment protocol again. Subjects may also have rigid/flexible bronchoscopy with laser or electrocautery snare for debulking of tumors. If disease exists bilaterally, only one side will be sprayed initially.
1028634|NCT00748085|E1|Reported Event|1-all Subjects|CryoSpray Ablation (TM) System: Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects will have initial cryospray treatment at Day 0. Subjects will undergo repeat bronchoscopy in the first seven days after the initial treatment to check for mucosal sloughing and to reassess luminal patency of the airway. Subjects may undergo up to one bronchoscopy with CSA therapy every seven days for a total of four (4) treatments in the first month. If they present with symptoms thereafter, then a repeat bronchoscopy will be performed; if luminal obstruction is noted, then the subject will begin the treatment protocol again. Subjects may also have rigid/flexible bronchoscopy with laser or electrocautery snare for debulking of tumors. If disease exists bilaterally, only one side will be sprayed initially.
1028635|NCT00748072|B3|Baseline|Total|Total of all reporting groups
1028636|NCT00748072|B2|Baseline|DDAVP|treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy
1028637|NCT00748072|B1|Baseline|Saline Solution|patients treated with 1 ml of s.c. saline solution
1028638|NCT00748072|P2|Participant Flow|DDAVP|treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy
1028639|NCT00748072|P1|Participant Flow|Saline Solution|patients treated with 1 ml of s.c. saline solution
1028640|NCT00748072|O2|Outcome|DDAVP|treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy
1028641|NCT00748072|O1|Outcome|Saline Solution|patients treated with 1 ml of s.c. saline solution
1028642|NCT00748072|E2|Reported Event|DDAVP|treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy
1028643|NCT00748072|E1|Reported Event|Saline Solution|patients treated with 1 ml of s.c. saline solution
1028644|NCT00747916|B1|Baseline|All Participants ICE PLS|
1028645|NCT00747916|P1|Participant Flow|All Participants ICE PLS|The study consists of one arm. All subjects enrolled in All participants ICE PLS
1028646|NCT00747916|O1|Outcome|All Participants ICE PLS|
1028647|NCT00747916|O1|Outcome|All Participants ICE PLS|
1028648|NCT00747916|E1|Reported Event|All Participants ICE PLS|
1028649|NCT00747812|B3|Baseline|Total|Total of all reporting groups
1028650|NCT00747812|B2|Baseline|Sham Stimulation (Control Group)|Sham Stimulation from activation of device to 12 weeks post-activation. Stimulation on from 12 weeks post-activation on.
1028651|NCT00747812|B1|Baseline|Active Stimulation (Treatment Group)|Stimulation on from activation to 12 weeks post-activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
1028652|NCT00747812|P2|Participant Flow|Sham Stimulation (Control Group)|Sham Stimulation from activation of device to 12 weeks post-activation. Stimulation on from 12 weeks post-activation on.
1028653|NCT00747812|P1|Participant Flow|Active Stimulation (Treatment Group)|Stimulation on from activation to 12 weeks post-activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
1028654|NCT00747812|O2|Outcome|Sham Stimulation (Control Group)|Sham stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation on from 12 weeks post-activation on.
1028655|NCT00747812|O1|Outcome|Active Stimulation (Treatment Group)|Active stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
1028656|NCT00747812|O2|Outcome|Sham Stimulation (Control Group)|Sham stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation on from 12 weeks post-activation on.
1028757|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
1028658|NCT00747812|E2|Reported Event|Sham Stimulation (Control Group)|Sham stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation on from 12 weeks post-activation on.
1028659|NCT00747812|E1|Reported Event|Active Stimulation (Treatment Group)|Active stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
1028660|NCT00747747|B4|Baseline|Total|Total of all reporting groups
1028661|NCT00747747|B3|Baseline|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning – evening)
1028662|NCT00747747|B2|Baseline|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning – evening)
1028663|NCT00747747|B1|Baseline|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
1028664|NCT00747747|P3|Participant Flow|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning – evening)
1028665|NCT00747747|P2|Participant Flow|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning – evening)
1028666|NCT00747747|P1|Participant Flow|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
1028667|NCT00747747|O3|Outcome|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
1028668|NCT00747747|O2|Outcome|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning - evening)
1028669|NCT00747747|O1|Outcome|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
1028670|NCT00747747|O3|Outcome|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
1028671|NCT00747747|O2|Outcome|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning - evening)
1028672|NCT00747747|O1|Outcome|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
1028673|NCT00747747|O3|Outcome|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
1028674|NCT00747747|O2|Outcome|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning - evening)
1028675|NCT00747747|O1|Outcome|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
1028676|NCT00747747|O3|Outcome|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
1028677|NCT00747747|O2|Outcome|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning - evening)
1028678|NCT00747747|O1|Outcome|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
1028679|NCT00747747|O3|Outcome|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
1028680|NCT00747747|O2|Outcome|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning - evening)
1028681|NCT00747747|O1|Outcome|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
1028682|NCT00747747|O3|Outcome|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
1028683|NCT00747747|O2|Outcome|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning - evening)
1028684|NCT00747747|O1|Outcome|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
1028685|NCT00747747|E3|Reported Event|Sinuclean Treated.|Sinuclean sprayed three times in each nostril, twice a day (morning - evening)
1028686|NCT00747747|E2|Reported Event|Saline Treated.|Saline solution sprayed three times in each nostril, twice a day (morning - evening)
1028687|NCT00747747|E1|Reported Event|Control|No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
1028688|NCT00747643|B3|Baseline|Total|Total of all reporting groups
1028689|NCT00747643|B2|Baseline|Placebo|Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
1028690|NCT00747643|B1|Baseline|Varenicline|For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
1028691|NCT00747643|P2|Participant Flow|Placebo|Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
1028692|NCT00747643|P1|Participant Flow|Varenicline|For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
1028693|NCT00747643|O2|Outcome|Placebo|Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
1028751|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
1028694|NCT00747643|O1|Outcome|Varenicline|For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
1028695|NCT00747643|O2|Outcome|Placebo|Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
1028696|NCT00747643|O1|Outcome|Varenicline|For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
1028697|NCT00747643|O2|Outcome|Placebo|Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
1028698|NCT00747643|O1|Outcome|Varenicline|For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
1028699|NCT00747643|O2|Outcome|Placebo|Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
1028700|NCT00747643|O1|Outcome|Varenicline|For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
1028701|NCT00747643|E2|Reported Event|Placebo|Participants in this group received a placebo instead of medication. The placebo was taken once a day on days 1-3, twice a day on days 4-15.
1028702|NCT00747643|E1|Reported Event|Varenicline|For participants in the varenicline group, the medication doses followed the recommended dose schedule for the first 15 days of treatment: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day on days 8-15.
1028703|NCT00747617|B3|Baseline|Total|Total of all reporting groups
1028704|NCT00747617|B2|Baseline|Normal|Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
1028705|NCT00747617|B1|Baseline|PCOS|Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
1028706|NCT00747617|P2|Participant Flow|Normal|Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
1028707|NCT00747617|P1|Participant Flow|PCOS|Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
1028708|NCT00747617|O2|Outcome|Normal|Each subject received a dose (1, 10, 25, 100, or 250 micrograms) of iv hCG.
1028709|NCT00747617|O1|Outcome|PCOS|Each subject received a dose (1, 10, 25, 100, or 250 micrograms) of iv hCG.
1028710|NCT00747617|E2|Reported Event|Normal|Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
1028711|NCT00747617|E1|Reported Event|PCOS|Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
1028712|NCT00747565|B3|Baseline|Total|Total of all reporting groups
1028713|NCT00747565|B2|Baseline|Monofocal Control Subjects|Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
1028714|NCT00747565|B1|Baseline|Tecnis Multifocal Subjects|Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints.
1028715|NCT00747565|P2|Participant Flow|Monofocal Control Subjects|Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
1028716|NCT00747565|P1|Participant Flow|Tecnis Multifocal Subjects|Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints.
1028717|NCT00747565|O2|Outcome|Monofocal Control Subjects|Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
1028718|NCT00747565|O1|Outcome|Tecnis Multifocal Subjects|Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints.
1028719|NCT00747565|O2|Outcome|Monofocal Control Subjects|Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
1028720|NCT00747565|O1|Outcome|Tecnis Multifocal Subjects|Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints.
1028721|NCT00747565|E2|Reported Event|Monofocal Control Subjects|Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
1028722|NCT00747565|E1|Reported Event|Tecnis Multifocal Subjects|Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints. One additional multifocal subject was enrolled but received an incorrect lens; this subject is included for adverse event reporting for a total of 348 (347 +1) multifocal subjects.
1028723|NCT00747552|B1|Baseline|Infants With Urinary Catheter in Place|Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively.
1028724|NCT00747552|P1|Participant Flow|Infants With Urinary Catheter in Place|Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively.
1028725|NCT00747552|O1|Outcome|Infants With Urinary Catheter in Place|Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively.
1028752|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
1028753|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
1028726|NCT00747552|O1|Outcome|Infants With Urinary Catheter in Place|Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively.
1028758|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
1028759|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
1028727|NCT00747552|E1|Reported Event|Infants With Urinary Catheter in Place|Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively.
1028728|NCT00747474|B1|Baseline|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
1028729|NCT00747474|P12|Participant Flow|Cohort 12 (60 mg/m^2)|Participants received 60 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
1028730|NCT00747474|P11|Participant Flow|Cohort 11 (50 mg/m^2)|Participants received 50 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
1028731|NCT00747474|P10|Participant Flow|Cohort 10 (40 mg/m^2)|Participants received 40 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
1028732|NCT00747474|P9|Participant Flow|Cohort 9 (35 mg/m^2)|Participants received 35 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
1028733|NCT00747474|P8|Participant Flow|Cohort 8 (40 mg/m^2)|Participants received 40 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
1028734|NCT00747474|P7|Participant Flow|Cohort 7 (30 mg/m^2)|Participants received 30 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
1028735|NCT00747474|P6|Participant Flow|Cohort 6 (20 mg/m^2)|Participants received 20 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
1028736|NCT00747474|P5|Participant Flow|Cohort 5 (13.5 mg/m^2)|Participants received 13.5 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
1028737|NCT00747474|P4|Participant Flow|Cohort 4 (9 mg/m^2)|Participants received 9 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
1028738|NCT00747474|P3|Participant Flow|Cohort 3 (6 mg/m^2)|Participants received 6 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
1028739|NCT00747474|P2|Participant Flow|Cohort 2 (3 mg/m^2)|Participants received 3 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
1028740|NCT00747474|P1|Participant Flow|Cohort 1 (1.5 mg/m^2)|Participants received 1.5 mg/m^2/dose, given as a 30 minute IV infusion on Days 1, 8 and 15 of a 28 day cycle. Each 28 day (4 week) period will constitute one cycle of treatment. Dose escalation of Lipotecan® will be based upon the safety and tolerability data from the first treatment cycle in each patient and determined by Safety Review Committee (SRC) for this study.
1028741|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
1028742|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
1028743|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
1028744|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
1028745|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
1028746|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
1028747|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
1028748|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
1028749|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
1028754|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
1028755|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
1028756|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
1028760|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
1028761|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
1028762|NCT00747474|O1|Outcome|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
1028763|NCT00747474|O1|Outcome|All Participants|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle according to the dose assigned.
1028764|NCT00747474|E1|Reported Event|Overall Population|Lipotecan was administered intravenously on day 1, 8 and 15 of a 28-day cycle.
1028765|NCT00747461|B1|Baseline|Cryo Spray Ablation|subjects will receive up to 4 -5 second cycles of cryospray ablation
1028766|NCT00747461|P1|Participant Flow|Cryo Spray Ablation|subjects receiving up to 4 -5 second spray cycles
1028767|NCT00747461|O1|Outcome|Cryo Spray Ablation|subjects receiving cryo spray ablation
1028768|NCT00747461|O1|Outcome|Cryo Spray Ablation|Subject receiving cryo spray ablation
1028769|NCT00747461|E1|Reported Event|All Subjects Receiving CSA Cryospray|"All subjects enrolled will received CSA cryospray.~CryoSpray Ablation (tm): The CryoSpray Ablation(TM) System is a cryosurgical device utilizing a low-pressure liquid nitrogen spray tip CSATM Catheter. Medical grade liquid nitrogen is the cryogen used in the device. The device is used to destroy unwanted tissue by the application of extreme cold with the focused application to select tissue. The cryogen is stored in a liquid nitrogen holding tank integrated into the system."
1028770|NCT00747435|B1|Baseline|Original Audiological Criteria|"Inclusion Criteria:~Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.~Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 *110+*110+ *110+ *110+ *90+~Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.~Electric Acoustic System: Combination of a cochlear implant and a hearing aid"
1028771|NCT00747435|P1|Participant Flow|Original Audiological Criteria|"Originally the study was designed to have two ARMs, but the second study ARM did not fully enroll. At the time of submission, the data for both ARMs was collapsed and data analysis was completed on all subjects as one group. The below inclusion criteria represents both ARMs as one group.~Inclusion Criteria:~Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.~Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 *110+*110+ *110+ *110+ *90+~Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.~Electric Acoustic System: Combination of a cochlear implant and a hearing aid"
1028772|NCT00747435|O1|Outcome|Original Audiological Criteria|"Inclusion Criteria:~Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.~Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 *110+*110+ *110+ *110+ *90+~Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.~Electric Acoustic System: Combination of a cochlear implant and a hearing aid"
1028773|NCT00747435|O1|Outcome|Original Audiological Criteria|"Inclusion Criteria:~Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.~Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 *110+*110+ *110+ *110+ *90+~Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.~Electric Acoustic System: Combination of a cochlear implant and a hearing aid"
1028774|NCT00747435|O1|Outcome|Original Audiological Criteria|"Inclusion Criteria:~Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.~Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 *110+*110+ *110+ *110+ *90+~Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.~Electric Acoustic System: Combination of a cochlear implant and a hearing aid"
1028775|NCT00747435|O1|Outcome|Original Audiological Criteria|"Inclusion Criteria:~Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.~Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 *110+*110+ *110+ *110+ *90+~Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.~Electric Acoustic System: Combination of a cochlear implant and a hearing aid"
1028776|NCT00747435|O1|Outcome|Original Audiological Criteria|"Inclusion Criteria:~Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.~Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 *110+*110+ *110+ *110+ *90+~Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.~Electric Acoustic System: Combination of a cochlear implant and a hearing aid"
1028777|NCT00747435|E1|Reported Event|Original Audiological Criteria|"Inclusion Criteria:~Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.~Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 0 0 0 0 0 70 70 70 Upper Limit: 65 65 75 *110+*110+ *110+ *110+ *90+~Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤60% in the best-aided condition.~Electric Acoustic System: Combination of a cochlear implant and a hearing aid"
1028778|NCT00747344|B3|Baseline|Total|Total of all reporting groups
1028779|NCT00747344|B2|Baseline|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
1028781|NCT00747344|P4|Participant Flow|Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) – receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving placebo at Week 12 and ustekinumab 45 mg at Week 16
1028782|NCT00747344|P3|Participant Flow|Placebo -> Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) – receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg at Week 12 and Week 16
1028783|NCT00747344|P2|Participant Flow|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
1028784|NCT00747344|P1|Participant Flow|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
1028785|NCT00747344|O2|Outcome|Ustekinumab 45 mg|
1028786|NCT00747344|O1|Outcome|Placebo|
1028787|NCT00747344|O2|Outcome|Ustekinumab 45 mg|
1028791|NCT00747344|E4|Reported Event|Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) – receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving placebo at Week 12 and ustekinumab 45 mg at Week 16
1028792|NCT00747344|E3|Reported Event|Placebo -> Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) – receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg at Week 12 and Week 16
1028793|NCT00747344|E2|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
1028794|NCT00747344|E1|Reported Event|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
1028795|NCT00747227|B3|Baseline|Total|Total of all reporting groups
1028796|NCT00747227|B2|Baseline|ZA9003 Intraocular Lens|monofocal acrylic intraocular lens
1028797|NCT00747227|B1|Baseline|ZV9003 Intraocular Lens|modified light transmission intraocular lens
1028798|NCT00747227|P2|Participant Flow|ZA9003 Intraocular Lens|monofocal acrylic intraocular lens
1028799|NCT00747227|P1|Participant Flow|ZV9003 Intraocular Lens|modified light transmission intraocular lens
1028800|NCT00747227|O2|Outcome|ZA9003 Intraocular Lens|monofocal acrylic intraocular lens
1028801|NCT00747227|O1|Outcome|ZV9003 Intraocular Lens|modified light transmission intraocular lens
1028802|NCT00747227|O2|Outcome|ZA9003 Intraocular Lens|monofocal acrylic intraocular lens
1028803|NCT00747227|O1|Outcome|ZV9003 Intraocular Lens|modified light transmission intraocular lens
1028804|NCT00747227|O2|Outcome|ZA9003 Intraocular Lens|monofocal acrylic intraocular lens
1028805|NCT00747227|O1|Outcome|ZV9003 Intraocular Lens|modified light transmission intraocular lens
1028806|NCT00747227|O2|Outcome|ZA9003 Intraocular Lens|monofocal acrylic intraocular lens
1028807|NCT00747227|O1|Outcome|ZV9003 Intraocular Lens|modified light transmission intraocular lens
1028808|NCT00747227|E2|Reported Event|ZA9003 Intraocular Lens|monofocal acrylic intraocular lens
1028809|NCT00747227|E1|Reported Event|ZV9003 Intraocular Lens|modified light transmission intraocular lens
1028810|NCT00747214|B3|Baseline|Total|Total of all reporting groups
1028811|NCT00747214|B2|Baseline|Placebo Plus DMARD Therapy|Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
1028812|NCT00747214|B1|Baseline|CRx-102 Plus DMARD Therapy|"Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy~The following dose escalation scheme was used:~Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone) Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone)"
1028813|NCT00747214|P2|Participant Flow|Placebo Plus DMARD Therapy|Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
1028814|NCT00747214|P1|Participant Flow|CRx-102 Plus DMARD Therapy|"Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy~The following dose escalation scheme was used:~Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone)~Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone)"
1028815|NCT00747214|O2|Outcome|Placebo Plus DMARD Therapy|Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
1028816|NCT00747214|O1|Outcome|CRx-102 Plus DMARD Therapy|"Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy~The following dose escalation scheme was used:~Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone) Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone)"
1028817|NCT00747214|O2|Outcome|Placebo Plus DMARD Therapy|Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
1028818|NCT00747214|O1|Outcome|CRx-102 Plus DMARD Therapy|"Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy~The following dose escalation scheme was used:~Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone) Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone)"
1028819|NCT00747214|O2|Outcome|Placebo Plus DMARD Therapy|Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
1028820|NCT00747214|O1|Outcome|CRx-102 Plus DMARD Therapy|"Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy~The following dose escalation scheme was used:~Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone) Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone)"
1028821|NCT00747214|O2|Outcome|Placebo Plus DMARD Therapy|Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
1028822|NCT00747214|O1|Outcome|CRx-102 Plus DMARD Therapy|"Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy~The following dose escalation scheme was used:~Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone) Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone)"
1028823|NCT00747214|E2|Reported Event|Placebo Plus DMARD Therapy|Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
1028824|NCT00747214|E1|Reported Event|CRx-102 Plus DMARD Therapy|"Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy~The following dose escalation scheme was used:~Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone) or placebo equivalent Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone) or placebo equivalent"
1028825|NCT00747149|B3|Baseline|Total|Total of all reporting groups
1028828|NCT00747149|P2|Participant Flow|Rosuvastatin Non-titrated|10 mg RSV or 20 mg RSV
1028829|NCT00747149|P1|Participant Flow|Rosuvastatin Titrated|10 mg rosuvastatin (RSV) as initial dose followed by 20 mg RSV as titrated dose or 20 mg rosuvastatin (RSV) as initial dose followed by 40 mg RSV as titrated dose
1028830|NCT00747149|O4|Outcome|Rosuvastatin 40 mg (Titrated)|At visit 1, LDL C level was measured. At visit 2, subjects received treatments with rosuvastatin 10 mg or 20 mg based on their visit 1 LDLC level. At visit 3 (6 weeks after visit 2) LDLC values was measured again and patients were titrated to the next highest dose of rosuvastatin if they had not reached target level of LDLC. Hence, 4 arms are listed, subjects who started on 10 mg could be on 10mg, 20mg by the end of the study and those subjects who started on 20mg could be on 20mg or 40 mg at the end of the study.
1028872|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
1028831|NCT00747149|O3|Outcome|Rosuvastatin 20 mg (Titrated)|At visit 1, LDL C level was measured. At visit 2, subjects received treatments with rosuvastatin 10 mg or 20 mg based on their visit 1 LDLC level. At visit 3 (6 weeks after visit 2) LDLC values was measured again and patients were titrated to the next highest dose of rosuvastatin if they had not reached target level of LDLC. Hence, 4 arms are listed, subjects who started on 10 mg could be on 10mg, 20mg by the end of the study and those subjects who started on 20mg could be on 20mg or 40 mg at the end of the study.
1028832|NCT00747149|O2|Outcome|Rosuvastatin 20 mg (Initial)|At visit 1, LDL C level was measured. At visit 2, subjects received treatments with rosuvastatin 10 mg or 20 mg based on their visit 1 LDLC level. At visit 3 (6 weeks after visit 2) LDLC values was measured again and patients were titrated to the next highest dose of rosuvastatin if they had not reached target level of LDLC. Hence, 4 arms are listed, subjects who started on 10 mg could be on 10mg, 20mg by the end of the study and those subjects who started on 20mg could be on 20mg or 40 mg at the end of the study.
1028833|NCT00747149|O1|Outcome|Rosuvastatin 10 mg (Initial)|At visit 1, LDL C level was measured. At visit 2, subjects received treatments with rosuvastatin 10 mg or 20 mg based on their visit 1 LDLC level. At visit 3 (6 weeks after visit 2) LDLC values was measured again and patients were titrated to the next highest dose of rosuvastatin if they had not reached target level of LDLC. Hence, 4 arms are listed, subjects who started on 10 mg could be on 10mg, 20mg by the end of the study and those subjects who started on 20mg could be on 20mg or 40 mg at the end of the study.
1028834|NCT00747149|E6|Reported Event|Rosuvastatin 40 mg (Titrated)|20 mg RSV as titrated dose
1028835|NCT00747149|E5|Reported Event|Rosuvastatin 20 mg (Titrated)|20 mg RSV as titrated dose
1028836|NCT00747149|E4|Reported Event|Rosuvastatin 20 mg (Continued, Non-titrated)|20 mg RSV as continued, non-titrated dose
1028837|NCT00747149|E3|Reported Event|Rosuvastatin 20 mg (Initial)|20 mg RSV as initial dose
1028838|NCT00747149|E2|Reported Event|Rosuvastatin 10 mg (Continued, Non-titrated)|10 mg RSV as a continued, non-titrated dose
1028839|NCT00747149|E1|Reported Event|Rosuvastatin 10 mg (Initial)|10 mg rosuvastatin (RSV) as initial dose
1028840|NCT00747006|B4|Baseline|Total|Total of all reporting groups
1028841|NCT00747006|B3|Baseline|Amendment 1 Type 2 Diabetes|Protocol amendment 1 participants with Type 2 diabetes given humalog (doses individualized for each patient) or Technosphere Insulin (doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)
1028842|NCT00747006|B2|Baseline|Original Protocol Type 2 Diabetes|Original protocol participants with Type 2 diabetes given Technosphere Insulin (TI - doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)
1028843|NCT00747006|B1|Baseline|Original Protocol Type 1 Diabetes|Original protocol participants with Type 1 diabetes given Technosphere Insulin (TI - doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)
1028844|NCT00747006|P3|Participant Flow|Amendment 1 Type 2 Diabetes|Protocol amendment 1 participants with Type 2 diabetes given humalog (doses individualized for each patient) or Technosphere Insulin (doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)
1028845|NCT00747006|P2|Participant Flow|Original Protocol Type 2 Diabetes|Original protocol participants with Type 2 diabetes given Technosphere Insulin (TI - doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)
1028846|NCT00747006|P1|Participant Flow|Original Protocol Type 1 Diabetes|Original protocol participants with Type 1 diabetes given Technosphere Insulin (TI - doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)
1028847|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
1028848|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
1028849|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
1028850|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
1028851|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
1028852|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
1028853|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
1028854|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
1028855|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
1028856|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
1028857|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
1028858|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
1028859|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
1028860|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
1028861|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
1028862|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
1028863|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
1028864|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
1028865|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
1028866|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
1028867|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
1028868|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
1028869|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
1028870|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
1028871|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
1028873|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
1028874|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
1028875|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
1028876|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
1028877|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
1028878|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
1028879|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
1028880|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
1028881|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
1028882|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
1028883|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
1028884|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
1028885|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
1028886|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
1028887|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
1028888|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
1028889|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
1028890|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
1028891|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
1028892|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
1028893|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
1028894|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
1028895|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
1028896|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
1028897|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
1028898|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
1028899|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
1028900|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
1028901|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
1028902|NCT00747006|O5|Outcome|200% Carbohydrate Load|Meal consisting of 2 times the carbohydrate load of the standard meal.
1028903|NCT00747006|O4|Outcome|150% Carbohydrate Load|Meal consisting of 1.5 times the carbohydrate load of the standard meal.
1028904|NCT00747006|O3|Outcome|50% Carbohydrate Load|Meal consisting of half of the carbohydrates from the standard meal
1028905|NCT00747006|O2|Outcome|0% Carbohydrate Load|Fasting state
1028906|NCT00747006|O1|Outcome|100% Carbohydrate Load|Standard meal to which subjects titrated their insulin dose.
1028907|NCT00747006|E4|Reported Event|Humalog Amendment 1 Type 2 DM|Humalog treated subjects in protocol amendment 1
1028908|NCT00747006|E3|Reported Event|TI Amendment 1 Type 2 DM|Technosphere Insulin treated subjects in protocol amendment 1
1028909|NCT00747006|E2|Reported Event|TI Original Protocol Type 2 DM|Original protocol type 2 diabetes mellitus subjects
1028910|NCT00747006|E1|Reported Event|TI Original Protocol Type 1 DM|Original protocol type 1 diabetes mellitus subjects
1028911|NCT00746954|B1|Baseline|Arm 1|Each patient will act as their own control, with comparisons over three nights, each night given buspirone (20mg), actetazolamide (250mg), or placebo
1028912|NCT00746954|P3|Participant Flow|Arm 3 BUS to ACET to PLA|Each patient will act as their own control, with comparisons over three nights, each night given buspirone (20mg), actetazolamide (250mg), or placebo
1028913|NCT00746954|P2|Participant Flow|Arm 2 Acet to Placebo to Bus|Each patient will act as their own control, with comparisons over three nights, each night given actetazolamide (Acet 250mg), or placebo or buspirone (Bus 20mg),
1028914|NCT00746954|P1|Participant Flow|Arm 1 Control to ACET to BUS|Each patient will act as their own control, with comparisons over three nights, this is placebo
1028915|NCT00746954|O3|Outcome|PLACEBO|Each patient will act as their own control, with comparisons over three nights
1028916|NCT00746954|O2|Outcome|ACETAZOLAMIDE|Each patient will act as their own control, with comparisons over three nights
1028917|NCT00746954|O1|Outcome|BUSPIRONE|Each patient will act as their own control, with comparisons over three nights, each night given buspirone (20mg), actetazolamide (250mg), or placebo
1028997|NCT00746798|O4|Outcome|Placebo|Participants who received placebo (saline) given one time subcutaneously
1028918|NCT00746954|E1|Reported Event|Arm 1|Each patient will act as their own control, with comparisons over three nights, each night given buspirone (20mg), actetazolamide (250mg), or placebo
1028919|NCT00746941|B5|Baseline|Total|Total of all reporting groups
1028920|NCT00746941|B4|Baseline|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
1028921|NCT00746941|B3|Baseline|Local Standard of Care; Mefloquine at Week 8|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~These participants chose to add 250 mg mefloquine by mouth at Week 8 for 3 days and then weekly through Week 24 to their local standard of care treatment."
1028922|NCT00746941|B2|Baseline|Local Standard of Care; Mefloquine at Week 4|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~These participants chose to add 250 mg mefloquine by mouth at Week 4 for 3 days and then weekly through Week 24 to their local standard of care treatment."
1028923|NCT00746941|B1|Baseline|Local Standard of Care|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~These participants received only local standard of care throughout the study; they did not choose to add 250 mg mefloquine at Week 4 (Day 28) or Week 8 (Day 56)."
1028924|NCT00746941|P4|Participant Flow|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
1028925|NCT00746941|P3|Participant Flow|Local Standard of Care; Mefloquine at Week 8|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~These participants chose to add 250 mg mefloquine by mouth at Week 8 for 3 days and then weekly through Week 24 to their local standard of care treatment."
1028926|NCT00746941|P2|Participant Flow|Local Standard of Care; Mefloquine at Week 4|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~These participants chose to add 250 mg mefloquine by mouth at Week 4 for 3 days and then weekly through Week 24 to their local standard of care treatment."
1028927|NCT00746941|P1|Participant Flow|Local Standard of Care|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~These participants received only local standard of care throughout the study; they did not choose to add 250 mg mefloquine at Week 4 (Day 28) or Week 8 (Day 56)."
1028928|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|"Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.~Also includes participants who were randomized to receive local standard of care (only) and added mefloquine at Week 4 or Week 8."
1028929|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
1028930|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
1028931|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
1028932|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
1028933|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
1028934|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
1028935|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
1028936|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
1028937|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
1028998|NCT00746798|O3|Outcome|ChimeriVax WN02 Vaccine High Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
1028938|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
1028939|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
1028940|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
1030479|NCT00741611|E1|Reported Event|Mesh|Ablation with HD Mesh Ablation System
1028941|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
1028942|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
1028943|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
1028944|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
1028945|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
1028946|NCT00746941|O2|Outcome|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
1028947|NCT00746941|O1|Outcome|Local Standard of Care|Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.
1028948|NCT00746941|E4|Reported Event|Local Standard of Care Plus Mefloquine 250 mg|Participants were randomized to receive local standard of care (which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital) and 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.
1028949|NCT00746941|E3|Reported Event|Local Standard of Care; Mefloquine at Week 8|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~Participants who chose to add mefloquine at Week 8 to their standard of care treatment are counted in this treatment arm once mefloquine treatment started."
1028950|NCT00746941|E2|Reported Event|Local Standard of Care; Mefloquine at Week 4|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~Participants who chose to add mefloquine at Week 4 to their standard of care treatment are counted in this treatment arm once mefloquine treatment started."
1028951|NCT00746941|E1|Reported Event|Local Standard of Care|"Participants were randomized to receive local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.~Participants who chose to add mefloquine at Weeks 4 or 8 to their standard of care treatment are counted in this treatment arm until the time of switching to mefloquine treatment."
1028952|NCT00746889|B3|Baseline|Total|Total of all reporting groups
1028953|NCT00746889|B2|Baseline|Placebo|Intraarticular injection of 0.9% saline
1028954|NCT00746889|B1|Baseline|Corticosteroid Injection|40 mg of intraarticular triamcinolone acetonide
1028955|NCT00746889|P2|Participant Flow|Placebo|Intraarticular injection of 0.9% saline
1028956|NCT00746889|P1|Participant Flow|Corticosteroid Injection|40 mg of intraarticular triamcinolone acetonide
1028957|NCT00746889|O2|Outcome|Noninflammatory Patients Who Received Corticosteroid Injection|Patients with noninflammatory characteristics on ultrasound who received saline placebo knee injections
1028958|NCT00746889|O1|Outcome|Inflammatory Patients Who Received Corticosteroid Injections|Patients with inflammatory characteristics on ultrsaound who were treated with corticosteroid knee injections
1028959|NCT00746889|O2|Outcome|Placebo|Intraarticular injection of 0.9% saline
1028960|NCT00746889|O1|Outcome|Corticosteroid Injection|40 mg of intraarticular triamcinolone acetonide
1028961|NCT00746889|E2|Reported Event|Placebo|Intraarticular injection of 0.9% saline
1028962|NCT00746889|E1|Reported Event|Corticosteroid Injection|40 mg of intraarticular triamcinolone acetonide
1028963|NCT00746863|B3|Baseline|Total|Total of all reporting groups
1028964|NCT00746863|B2|Baseline|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
1028965|NCT00746863|B1|Baseline|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
1028966|NCT00746863|P2|Participant Flow|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
1028967|NCT00746863|P1|Participant Flow|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
1028968|NCT00746863|O2|Outcome|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
1028969|NCT00746863|O1|Outcome|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
1028970|NCT00746863|O2|Outcome|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
1028971|NCT00746863|O1|Outcome|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
1028972|NCT00746863|O2|Outcome|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
1028973|NCT00746863|O1|Outcome|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
1028974|NCT00746863|O2|Outcome|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
1028975|NCT00746863|O1|Outcome|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
1028976|NCT00746863|O2|Outcome|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
1028977|NCT00746863|O1|Outcome|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
1028978|NCT00746863|E2|Reported Event|Control Group - No Marcaine|Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space.
1028979|NCT00746863|E1|Reported Event|Intervention Group - Received Marcaine|Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
1028980|NCT00746798|B5|Baseline|Total|Total of all reporting groups
1028981|NCT00746798|B4|Baseline|Placebo|Participants who received placebo (saline) given one time subcutaneously
1028982|NCT00746798|B3|Baseline|ChimeriVax WN02 Vaccine High Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
1028983|NCT00746798|B2|Baseline|ChimeriVax WN02 Vaccine Medium Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
1028984|NCT00746798|B1|Baseline|ChimeriVax WN02 Vaccine Low Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
1028985|NCT00746798|P4|Participant Flow|Placebo|Participants who received placebo (saline) given one time subcutaneously
1028986|NCT00746798|P3|Participant Flow|ChimeriVax WN02 Vaccine High Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
1028987|NCT00746798|P2|Participant Flow|ChimeriVax WN02 Vaccine Medium Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
1028988|NCT00746798|P1|Participant Flow|ChimeriVax WN02 Vaccine Low Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
1028989|NCT00746798|O4|Outcome|Placebo|Participants who received placebo (saline) given one time subcutaneously
1028990|NCT00746798|O3|Outcome|ChimeriVax WN02 Vaccine High Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
1028991|NCT00746798|O2|Outcome|ChimeriVax WN02 Vaccine Medium Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
1028992|NCT00746798|O1|Outcome|ChimeriVax WN02 Vaccine Low Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
1028993|NCT00746798|O4|Outcome|Placebo|Participants who received placebo (saline) given one time subcutaneously
1028994|NCT00746798|O3|Outcome|ChimeriVax WN02 Vaccine High Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
1028995|NCT00746798|O2|Outcome|ChimeriVax WN02 Vaccine Medium Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
1028996|NCT00746798|O1|Outcome|ChimeriVax WN02 Vaccine Low Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
1029074|NCT00746733|O1|Outcome|Vyvanse + Prilosec OTC|
1028999|NCT00746798|O2|Outcome|ChimeriVax WN02 Vaccine Medium Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
1029000|NCT00746798|O1|Outcome|ChimeriVax WN02 Vaccine Low Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
1029001|NCT00746798|O4|Outcome|Placebo|Participants who received placebo (saline) given one time subcutaneously
1029002|NCT00746798|O3|Outcome|ChimeriVax WN02 Vaccine High Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
1029003|NCT00746798|O2|Outcome|ChimeriVax WN02 Vaccine Medium Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
1029004|NCT00746798|O1|Outcome|ChimeriVax WN02 Vaccine Low Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
1029005|NCT00746798|E4|Reported Event|Placebo|Participants who received placebo (saline) given one time subcutaneously
1029006|NCT00746798|E3|Reported Event|ChimeriVax WN02 Vaccine High Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 5log10 plaque forming units given one time subcutaneously
1029007|NCT00746798|E2|Reported Event|ChimeriVax WN02 Vaccine Medium Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 4log10 plaque forming units given one time subcutaneously
1029008|NCT00746798|E1|Reported Event|ChimeriVax WN02 Vaccine Low Dose|Participants who received ChimeriVax-WN02 vaccine at a dose of approximately 4 x 3log10 plaque forming units given one time subcutaneously
1029009|NCT00746785|B4|Baseline|Total|Total of all reporting groups
1029010|NCT00746785|B3|Baseline|C - Placebo|placebo : placebo
1029011|NCT00746785|B2|Baseline|B - 5 mg Olanzapine|"5 mg Olanzapine~olanzapine : 5 mg"
1029012|NCT00746785|B1|Baseline|A - 2.5 mg Olanzapine|"2.5 mg Olanzapine~olanzapine : 2.5 mg"
1029013|NCT00746785|P3|Participant Flow|C - Placebo|placebo : placebo
1029014|NCT00746785|P2|Participant Flow|B - 5 mg Olanzapine|"5 mg Olanzapine~olanzapine : 5 mg"
1029015|NCT00746785|P1|Participant Flow|A - 2.5 mg Olanzapine|"2.5 mg Olanzapine~olanzapine : 2.5 mg"
1029016|NCT00746785|O3|Outcome|C - Placebo|placebo : placebo
1029017|NCT00746785|O2|Outcome|B - 5 mg Olanzapine|"5 mg Olanzapine~olanzapine : 5 mg"
1029018|NCT00746785|O1|Outcome|A - 2.5 mg Olanzapine|"2.5 mg Olanzapine~olanzapine : 2.5 mg"
1029019|NCT00746785|E3|Reported Event|C - Placebo|placebo : placebo
1029020|NCT00746785|E2|Reported Event|B - 5 mg Olanzapine|"5 mg Olanzapine~olanzapine : 5 mg"
1029021|NCT00746785|E1|Reported Event|A - 2.5 mg Olanzapine|"2.5 mg Olanzapine~olanzapine : 2.5 mg"
1029022|NCT00746733|B1|Baseline|Entire Study Population|
1029023|NCT00746733|P2|Participant Flow|Adderall XR First|Adderall XR 20 mg dosed once in the first intervention, Vyvanse 50mg dosed once in the second intervention, Adderall XR 20mg + Prilosec OTC 40mg dosed once in the third intervention, Vyvanse 50mg + Prilosec OTC 40mg dosed once in the fourth intervention.
1029024|NCT00746733|P1|Participant Flow|Vyvanse First|Vyvanse 50mg dosed once in the first intervention, Adderall XR 20 mg dosed once in the second intervention, Vyvanse 50mg + Prilosec OTC 40mg dosed once in the third intervention, Adderall XR 20mg + Prilosec OTC 40mg dosed once in the fourth intervention.
1029025|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
1029026|NCT00746733|O1|Outcome|Adderall XR|
1029027|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
1029028|NCT00746733|O1|Outcome|Adderall XR|
1029029|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
1029030|NCT00746733|O1|Outcome|Adderall XR|
1029031|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
1029032|NCT00746733|O1|Outcome|Adderall XR|
1029033|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
1029034|NCT00746733|O1|Outcome|Adderall XR|
1029035|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
1029036|NCT00746733|O1|Outcome|Adderall XR|
1029037|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
1029038|NCT00746733|O1|Outcome|Adderall XR|
1029039|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
1029040|NCT00746733|O1|Outcome|Adderall XR|
1029041|NCT00746733|O4|Outcome|Adderall XR + Prilosec OTC|
1029042|NCT00746733|O3|Outcome|Vyvanse + Prilosec OTC|
1029043|NCT00746733|O2|Outcome|Adderall XR|
1029044|NCT00746733|O1|Outcome|Vyvanse|
1029045|NCT00746733|O4|Outcome|Adderall XR + Prilosec OTC|
1029046|NCT00746733|O3|Outcome|Vyvanse + Prilosec OTC|
1029047|NCT00746733|O2|Outcome|Adderall XR|
1029048|NCT00746733|O1|Outcome|Vyvanse|
1029049|NCT00746733|O4|Outcome|Adderall XR + Prilosec OTC|
1029050|NCT00746733|O3|Outcome|Vyvanse + Prilosec OTC|
1029051|NCT00746733|O2|Outcome|Adderall XR|
1029052|NCT00746733|O1|Outcome|Vyvanse|
1029053|NCT00746733|O4|Outcome|Adderall XR + Prilosec OTC|
1029054|NCT00746733|O3|Outcome|Vyvanse + Prilosec OTC|
1029055|NCT00746733|O2|Outcome|Adderall XR|
1029056|NCT00746733|O1|Outcome|Vyvanse|
1029057|NCT00746733|O4|Outcome|Adderall XR + Prilosec OTC|
1029058|NCT00746733|O3|Outcome|Vyvanse + Prilosec OTC|
1029059|NCT00746733|O2|Outcome|Adderall XR|
1029060|NCT00746733|O1|Outcome|Vyvanse|
1029061|NCT00746733|O4|Outcome|Adderall XR + Prilosec OTC|
1029062|NCT00746733|O3|Outcome|Vyvanse + Prilosec OTC|
1029063|NCT00746733|O2|Outcome|Adderall XR|
1029064|NCT00746733|O1|Outcome|Vyvanse|
1029065|NCT00746733|O4|Outcome|Adderall XR + Prilosec OTC|
1029066|NCT00746733|O3|Outcome|Vyvanse + Prilosec OTC|
1029067|NCT00746733|O2|Outcome|Adderall XR|
1029068|NCT00746733|O1|Outcome|Vyvanse|
1029069|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
1029070|NCT00746733|O1|Outcome|Vyvanse + Prilosec OTC|
1029071|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
1029072|NCT00746733|O1|Outcome|Vyvanse + Prilosec OTC|
1029073|NCT00746733|O2|Outcome|Adderall XR + Prilosec OTC|
1029083|NCT00746694|B1|Baseline|Caelyx|Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.
1029084|NCT00746694|P1|Participant Flow|Caelyx|Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.
1029085|NCT00746694|O1|Outcome|Caelyx|Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.
1029280|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
1029086|NCT00746694|O1|Outcome|Caelyx|Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.
1029087|NCT00746694|E1|Reported Event|Caelyx|Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.
1029088|NCT00746668|B1|Baseline|All Study Participants|All subjects' reading performances were initially assessed before training began. Reading performance were assessed using sentences displayed on a computer monitor. Two lines of text were presented at the center of the monitor with each subject seated at a viewing distance of 40cm. The subject read each sentence aloud and indicated whether it made sense by responding true or false. Reading speed was calculated using an algorithm similar to that used for the MNRead test.
1029089|NCT00746668|P7|Participant Flow|Group 6|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 3 (Reading Practice with RSVP) Training Session 2: Module 2 (Control of Reading Eye Movements) Training Session 3: Module 1 (Visual Awareness and Eccentric Viewing)"
1029090|NCT00746668|P6|Participant Flow|Group 5|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 2 (Control of Reading Eye Movements) Training Session 2: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 3: Module 3 (Reading Practice with RSVP)"
1029091|NCT00746668|P5|Participant Flow|Group 4|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 2: Module 3 (Reading Practice with RSVP) Training Session 3: Module 2 (Control of Reading Eye Movements)"
1029092|NCT00746668|P4|Participant Flow|Group 3|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 3 (Reading Practice with RSVP) Training Session 2: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 3: Module 2 (Control of Reading Eye Movements)"
1029093|NCT00746668|P3|Participant Flow|Group 2|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 2 (Control of Reading Eye Movements) Training Session 2: Module 3 (Reading Practice with RSVP) Training Session 3: Module 1 (Visual Awareness and Eccentric Viewing)"
1029094|NCT00746668|P2|Participant Flow|Group 1|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 2: Module 2 (Control of Reading Eye Movements) Training Session 3: Module 3 (Reading Practice with RSVP)"
1029095|NCT00746668|P1|Participant Flow|Control Group|Subjects randomly assigned to this group had their training delayed for 18 weeks. These subjects underwent four assessments: baseline and at three 6-week intervals' but, they were not given any training during this time. After this data collection period, these control subjects were given training on the three modules. However, their performance after each period of training was not assessed.
1029096|NCT00746668|O4|Outcome|Arm 4: Assessment After Module 3|Assessment after six-weeks of training in Module 3 (RSVP Reading).
1029097|NCT00746668|O3|Outcome|Arm 3: Assessment After Module 2|Assessment after six-weeks of training in Module 2 (Eye Movement Training).
1029098|NCT00746668|O2|Outcome|Arm 2: Assessment After Module 1|Assessment after six-weeks of training in Module 1 (PRL Awareness Training).
1029099|NCT00746668|O1|Outcome|Arm 1: Pre-Training|Baseline Assessment prior to training.
1029100|NCT00746668|E7|Reported Event|Group 6|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 3 (Reading Practice with RSVP) Training Session 2: Module 2 (Control of Reading Eye Movements) Training Session 3: Module 1 (Visual Awareness and Eccentric Viewing)"
1029147|NCT00746512|O1|Outcome|Prednisone 15 mg|Prednisone 15 mg tablets once daily for 15 days
1029101|NCT00746668|E6|Reported Event|Group 5|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 2 (Control of Reading Eye Movements) Training Session 2: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 3: Module 3 (Reading Practice with RSVP)"
1029322|NCT00745095|B6|Baseline|Control PIEE Only|(Control, GFR>=50ml/min) PIEE only (no NG)
1029102|NCT00746668|E5|Reported Event|Group 4|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 2: Module 3 (Reading Practice with RSVP) Training Session 3: Module 2 (Control of Reading Eye Movements)"
1029103|NCT00746668|E4|Reported Event|Group 3|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 3 (Reading Practice with RSVP) Training Session 2: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 3: Module 2 (Control of Reading Eye Movements)"
1029104|NCT00746668|E3|Reported Event|Group 2|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 2 (Control of Reading Eye Movements) Training Session 2: Module 3 (Reading Practice with RSVP) Training Session 3: Module 1 (Visual Awareness and Eccentric Viewing)"
1029105|NCT00746668|E2|Reported Event|Group 1|"The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments.~Subjects in this group were trained according to the following counterbalanced module order:~Training Session 1: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 2: Module 2 (Control of Reading Eye Movements) Training Session 3: Module 3 (Reading Practice with RSVP)"
1029106|NCT00746668|E1|Reported Event|Control Group|Subjects randomly assigned to this group had their training delayed for 18 weeks. These subjects underwent four assessments: baseline and at three 6-week intervals' but, they were not given any training during this time. After this data collection period, these control subjects were given training on the three modules. However, their performance after each period of training was not assessed.
1029107|NCT00746590|B1|Baseline|Prolarix Treatment Group|Prolarix (tretazicar co-administered with caricotamide): Prolarix (26.6 mg/m2 tretazicar co-administered with 200 mg/m2 caricotamide) administered intravenously every 21 days until disease progression
1029108|NCT00746590|P1|Participant Flow|Prolarix Treatment Group|Prolarix (tretazicar co-administered with caricotamide): Prolarix (26.6 mg/m2 tretazicar co-administered with 200 mg/m2 caricotamide) administered intravenously every 21 days until disease progression
1029109|NCT00746590|O1|Outcome|Prolarix Group|Prolarix (tretazicar co-administered with caricotamide): Prolarix (26.6 mg/m2 tretazicar co-administered with 200 mg/m2 caricotamide) administered intravenously every 21 days until disease progression
1029110|NCT00746590|E1|Reported Event|Prolarix Treatment Group|Prolarix (tretazicar co-administered with caricotamide): Prolarix (26.6 mg/m2 tretazicar co-administered with 200 mg/m2 caricotamide) administered intravenously every 21 days until disease progression
1029111|NCT00746564|B1|Baseline|Open Label|All patients who were implanted with the SJM Confirm device.
1029112|NCT00746564|P1|Participant Flow|SJM Confirm Device|All patients in this study received the St. Jude Medical (SJM Confirm device.
1029113|NCT00746564|O1|Outcome|SJM Confirm Device|All patients implanted with the SJM Confirm device.
1029114|NCT00746564|O1|Outcome|SJM Confirm Device|All patients implanted with an SJM Confirm device.
1029115|NCT00746564|O1|Outcome|SJM Confirm Device|All patients implanted with an SJM Confirm device.
1029116|NCT00746564|O1|Outcome|SJM Confirm Device|All patients in this study received the SJM Confirm device.
1029117|NCT00746564|O1|Outcome|SJM Confirm Device|All patients in this study received the SJM Confirm device.
1029118|NCT00746564|O1|Outcome|SJM Confirm Device|All patients in this study received the SJM Confirm device.
1029119|NCT00746564|O1|Outcome|SJM Confirm Device|All patients in this study received the SJM Confirm device.
1029120|NCT00746564|O1|Outcome|SJM Confirm Device|All patients in this study received the SJM Confirm device.
1029121|NCT00746564|O1|Outcome|SJM Confirm Device|All patients in this study received the SJM Confirm device.
1029122|NCT00746564|O1|Outcome|SJM Confirm Device|All patients in this study received the SJM Confirm device.
1029123|NCT00746564|E1|Reported Event|SJM Confirm Device|All patients in this study received the SJM Confirm device.
1029124|NCT00746551|B3|Baseline|Total|Total of all reporting groups
1029125|NCT00746551|B2|Baseline|Ferrous Fumarate, Ferri-6, Oral Tablet|Initially, there were 194 subjects enrolled but 114 cases were excluded from the study. Among those, 104 cases did not meet the inclusion criteria and 10 cases refused to take part. A total of 80 eligible patients were equally randomised and allocated in to 2 groups of intravenous sucrose complex-group (ISC) and oral ferrous fuamrate-group (OFF) . At GA of 36 weeks, there were 4 cases of the OFF-group and 2 cases of the ISC-group lost to follow-up. At delivery, there were 50 patients remained in the study whereas 30 patients were excluded from statistical analysis due to losing to follow-up (16 cases), delivery at other hospitals (10 cases) and preterm deliveries (4 cases).
1029145|NCT00746512|O3|Outcome|Prednisone 7.5 mg|"Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
1029148|NCT00746512|O4|Outcome|Placebo 7.5 mg|"Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
1029149|NCT00746512|O3|Outcome|Prednisone 7.5 mg|"Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
1029126|NCT00746551|B1|Baseline|Iron Sucrose, Venofer, Intravenous Drug|Initially, there were 194 subjects enrolled but 114 cases were excluded from the study. Among those, 104 cases did not meet the inclusion criteria and 10 cases refused to take part. A total of 80 eligible patients were equally randomised and allocated in to 2 groups of intravenous sucrose complex-group (ISC) and oral ferrous fuamrate-group (OFF) . At GA of 36 weeks, there were 4 cases of the OFF-group and 2 cases of the ISC-group lost to follow-up. At delivery, there were 50 patients remained in the study whereas 30 patients were excluded from statistical analysis due to losing to follow-up (16 cases), delivery at other hospitals (10 cases) and preterm deliveries (4 cases).
1029127|NCT00746551|P2|Participant Flow|Ferrous Fumarate, Ferri-6®, Oral Tablet|In the O-group, women had to take 3 ferrous fumarate tablets (Ferli-6®) everyday with a total of 200 mg of elemental iron per day from 33 weeks gestation until delivery. Emphasizing and monitoring for compliance to the treatment protocol were carried out.
1029128|NCT00746551|P1|Participant Flow|Iron Sucrose, Venofer®, Intravenous Drug|Women in the IV-group received 500 mg iron sucrose (Venofer®, Vifor International AG, St. Gallen, Switzerland) divided into three weekly administrations. Two doses of 200 mg iron sucrose were given at 33 and 34 weeks gestation while the remaining (100 mg) was infused at gestation of 35 weeks. Thereafter, women in this group received no further iron therapy until delivery. In preparation, 200 mg of iron sucrose was diluted into 100 ml of 0.9% saline solution.
1029129|NCT00746551|O2|Outcome|Ferrous Fumarate, Ferri-6, Oral Tablet|The patients in the control group (OFF-group) were instructed to have 3 oral ferrous fumarate tablets (Ferli-6®, Continental-Pharm, Thailand) daily with a total of 200 mg elemental iron per day until delivery. The remaining of OFF tablets was counted at every visit to evaluate patient compliance. Patients in the OFF-group who took less than 80% of the allocated medication were withdrawn from the trial.
1029130|NCT00746551|O1|Outcome|Iron Sucrose, Venofer, Intravenous Drug|"Patients in the study group (ISC-group) were given 500 mg of ISC (Venofer®, Vifor International AG, St. Gallen, Switzerland) in three divided doses. The administration was given weekly with the maximum dose of 200 mg from GA 33 to 35 weeks. Thereafter, no other iron supplementation was given to this group until delivery. In preparation, 200 mg of ISC was diluted into 100 ml of 0.9% saline solution. Test dose was performed by slow infusion of 5 ml solution within 5 minutes. This was only required on the first ISC treatment.~If no adverse reactions were observed in 15 minutes, the remaining solution was infused to the patient within 30 minutes. Subsequent infusions were administered in 40 minutes. Careful post infusion observation was conducted in every case for at least 30 minutes to ensure patient safety.~Patients in the ISC-group who failed to complete the 3-week treatment course were withdrawn from the trial."
1029131|NCT00746551|O2|Outcome|Ferrous Fumarate, Ferri-6, Oral Tablet|The patients in the control group (OFF-group) were instructed to have 3 oral ferrous fumarate tablets (Ferli-6®, Continental-Pharm, Thailand) daily with a total of 200 mg elemental iron per day until delivery. The remaining of OFF tablets was counted at every visit to evaluate patient compliance. Patients in the OFF-group who took less than 80% of the allocated medication were withdrawn from the trial.
1029132|NCT00746551|O1|Outcome|Iron Sucrose, Venofer, Intravenous Drug|"Patients in the study group (ISC-group) were given 500 mg of ISC (Venofer®, Vifor International AG, St. Gallen, Switzerland) in three divided doses. The administration was given weekly with the maximum dose of 200 mg from GA 33 to 35 weeks. Thereafter, no other iron supplementation was given to this group until delivery. In preparation, 200 mg of ISC was diluted into 100 ml of 0.9% saline solution. Test dose was performed by slow infusion of 5 ml solution within 5 minutes. This was only required on the first ISC treatment.~If no adverse reactions were observed in 15 minutes, the remaining solution was infused to the patient within 30 minutes. Subsequent infusions were administered in 40 minutes. Careful post infusion observation was conducted in every case for at least 30 minutes to ensure patient safety.~Patients in the ISC-group who failed to complete the 3-week treatment course were withdrawn from the trial."
1029133|NCT00746551|E2|Reported Event|Ferrous Fumarate, Ferri-6®, Oral Tablet|Patients in the OFF-group who took less than 80% of the allocated medication were withdrawn from the trial.
1029134|NCT00746551|E1|Reported Event|Iron Sucrose, Venofer®, Intravenous Drug|"In preparation, 200 mg of ISC was diluted into 100 ml of 0.9% saline solution. Test dose was performed by slow infusion of 5 ml solution within 5 minutes. This was only required on the first ISC treatment.~If no adverse reactions were observed in 15 minutes, the remaining solution was infused to the patient within 30 minutes. Subsequent infusions were administered in 40 minutes. Careful post infusion observation was conducted in every case for at least 30 minutes to ensure patient safety.~Patients in the ISC-group who failed to complete the 3-week treatment course were withdrawn from the trial."
1029135|NCT00746512|B5|Baseline|Total|Total of all reporting groups
1029136|NCT00746512|B4|Baseline|Placebo 7.5 mg|"Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
1029137|NCT00746512|B3|Baseline|Prednisone 7.5 mg|"Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
1029138|NCT00746512|B2|Baseline|Placebo 15 mg|Prednisone 15 mg placebo tablets once daily for 15 days
1029139|NCT00746512|B1|Baseline|Prednisone 15 mg|Prednisone 15 mg tablets once daily for 15 days
1029140|NCT00746512|P4|Participant Flow|Placebo 7.5 mg|"Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
1029141|NCT00746512|P3|Participant Flow|Prednisone 7.5 mg|"Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
1029142|NCT00746512|P2|Participant Flow|Placebo 15 mg|Prednisone 15 mg placebo tablets once daily for 15 days
1029143|NCT00746512|P1|Participant Flow|Prednisone 15 mg|Prednisone 15 mg tablets once daily for 15 days
1029144|NCT00746512|O4|Outcome|Placebo 7.5 mg|"Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
1029146|NCT00746512|O2|Outcome|Placebo 15 mg|Prednisone 15 mg placebo tablets once daily for 15 days
1029152|NCT00746512|E4|Reported Event|Placebo 7.5 mg|"Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
1029153|NCT00746512|E3|Reported Event|Prednisone 7.5 mg|"Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days~As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis."
1029154|NCT00746512|E2|Reported Event|Placebo 15 mg|Prednisone 15 mg placebo tablets once daily for 15 days
1029155|NCT00746512|E1|Reported Event|Prednisone 15 mg|Prednisone 15 mg tablets once daily for 15 days
1029156|NCT00746421|B3|Baseline|Total|Total of all reporting groups
1029157|NCT00746421|B2|Baseline|Placebo Group|Placebo one pill per day matching 200, 300, or 400 mg active medications
1029158|NCT00746421|B1|Baseline|Quetiapine XR Group|Quetiapine XR 200-400 mg/day
1029159|NCT00746421|P2|Participant Flow|Placebo Group|Placebo one pill per day matching 200, 300, or 400 mg active medications
1029160|NCT00746421|P1|Participant Flow|Quetiapine XR Group|Quetiapine XR 200-400 mg/day
1029161|NCT00746421|O2|Outcome|Placebo Group|Placebo one pill per day matching 200, 300, or 400 mg active medications
1029162|NCT00746421|O1|Outcome|Quetiapine XR Group|Quetiapine XR 200-400 mg/day
1029163|NCT00746421|O2|Outcome|Placebo Group|Placebo one pill per day matching 200, 300, or 400 mg active medications
1029164|NCT00746421|O1|Outcome|Quetiapine XR Group|Quetiapine XR 200-400 mg/day
1029165|NCT00746421|E2|Reported Event|Placebo Group|Placebo one pill per day matching 200, 300, or 400 mg active medications
1029166|NCT00746421|E1|Reported Event|Quetiapine XR Group|Quetiapine XR 200-400 mg/day
1029167|NCT00746395|B3|Baseline|Total|Total of all reporting groups
1029168|NCT00746395|B2|Baseline|Sugar Pill|Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
1029169|NCT00746395|B1|Baseline|Lubiprostone 24mcg Single Dose|lubiprostone 24mcg single dose po prior to capsule endoscopy
1029170|NCT00746395|P2|Participant Flow|Sugar Pill|Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
1029171|NCT00746395|P1|Participant Flow|Lubiprostone 24mcg Single Dose|lubiprostone 24mcg single dose po prior to capsule endoscopy
1029172|NCT00746395|O2|Outcome|Sugar Pill|Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
1029173|NCT00746395|O1|Outcome|Lubiprostone 24mcg Single Dose|lubiprostone 24mcg single dose po prior to capsule endoscopy
1029174|NCT00746395|O2|Outcome|Sugar Pill|Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
1029175|NCT00746395|O1|Outcome|Lubiprostone 24mcg Single Dose|lubiprostone 24mcg single dose po prior to capsule endoscopy
1029176|NCT00746395|E2|Reported Event|Sugar Pill|Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
1029177|NCT00746395|E1|Reported Event|Lubiprostone 24mcg Single Dose|lubiprostone 24mcg single dose po prior to capsule endoscopy
1029178|NCT00746356|B1|Baseline|All Patients|All patients enrolled in the study
1029179|NCT00746356|P2|Participant Flow|ICD Device Patients|All patients with an implantable cardioverter defibrillator (ICD) device enrolled in the study.
1029180|NCT00746356|P1|Participant Flow|CRT-D Device Patients|All patients with a cardiac resynchronization therapy device (CRT-D)enrolled in the study.
1029181|NCT00746356|O1|Outcome|Participants With CRT-D Devices|Per protocol, the first 43 CRT-D participants who successfully completed both an automatic and manual threshold in the left ventricle.
1029182|NCT00746356|O1|Outcome|Participants With CRT-D Devices|Per protocol, the first 43 CRT-D participants who successfully completed both an automatic and manual capture threshold in the right ventricle
1029183|NCT00746356|O1|Outcome|Participants With Single or Dual Chamber ICDs|Per protocol, the first 38 participants with an ICD who successfully completed both an automatic and manual capture threshold in the right ventricle
1029184|NCT00746356|O1|Outcome|Participants With Dual Chamber ICDs or CRTD Devices|Per protocol, the first 19 participants who successfully completed both an automatic and manual capture threshold
1029185|NCT00746356|O1|Outcome|Participants Successfully Implanted With Devices|All participants successfully implanted with an ICD or CRT-D
1029186|NCT00746356|E1|Reported Event|All Patients|All patients enrolled in the study
1029187|NCT00746330|B5|Baseline|Total|Total of all reporting groups
1029188|NCT00746330|B4|Baseline|PL, MFF, F12M, F12D|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 2: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 3: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 4: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
1029214|NCT00746330|O4|Outcome|Placebo|Placebo via pMDI/ Placebo via DPI
1029215|NCT00746330|O3|Outcome|F12D|Placebo via pMDI/ Formoterol fumarate 12 μg via DPI
1029216|NCT00746330|O2|Outcome|F12M|Formoterol fumarate 12 μg via pMDI/ Placebo via DPI
1029217|NCT00746330|O1|Outcome|MFF10|Formoterol fumarate 10μg/Mometasone furoate 100μg via pMDI
1029218|NCT00746330|E4|Reported Event|Placebo|Placebo via pMDI/ Placebo via DPI
1029219|NCT00746330|E3|Reported Event|MFF10|Formoterol fumarate 10μg/Mometasone furoate 100μg via pMDI
1029189|NCT00746330|B3|Baseline|MFF, F12D, PL, F12M|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 2: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 3: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 4: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
1029190|NCT00746330|B2|Baseline|F12D, F12M, MFF, PL|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 2: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 3: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 4: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
1029191|NCT00746330|B1|Baseline|F12M, PL, F12D, MFF|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 2: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 3: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 4: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
1029192|NCT00746330|P4|Participant Flow|PL, MFF, F12M, F12D|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 2: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 3: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 4: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
1029193|NCT00746330|P3|Participant Flow|MFF, F12D, PL, F12M|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 2: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 3: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 4: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
1029194|NCT00746330|P2|Participant Flow|F12D, F12M, MFF, PL|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 2: Formoterol fumarate 12 μg via pMDI + placebo to formoterol fumarate via DPI; Period 3: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI; Period 4: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
1029195|NCT00746330|P1|Participant Flow|F12M, PL, F12D, MFF|Participants received a single dose of each treatment in the following order, separated by a washout period of 6-7 days: Period 1: Formoterol fumarate 12 μg via Pressurized Metered Dose Inhaler (pMDI) + placebo to formoterol fumarate via Dry Powder Inhaler (DPI); Period 2: Placebo to formoterol fumarate / mometasone furoate via pMDI + placebo to formoterol fumarate via DPI; Period 3: Placebo to formoterol fumarate / mometasone furoate via pMDI + formoterol fumarate via DPI; Period 4: Formoterol fumarate / mometasone furoate 10 μg / 100 μg via pMDI + placebo to formoterol fumarate via DPI. Participants were allowed to continue their regular asthma maintenance inhaled corticosteroid medication throughout the study and were supplied with the short-acting β2-agonist (SABA) salbutamol as rescue medication.
1029196|NCT00746330|O3|Outcome|F12D|Formoterol fumarate 12 μg via DPI/Placebo via pMDI
1029197|NCT00746330|O2|Outcome|F12M|Formoterol fumarate 12 μg via pMDI/ Placebo via DPI
1029198|NCT00746330|O1|Outcome|MFF10|Formoterol fumarate 10μg/Mometasone furoate 100μg via pMDI
1029199|NCT00746330|O3|Outcome|F12D|Formoterol fumarate 12 μg via DPI/Placebo via pMDI
1029200|NCT00746330|O2|Outcome|F12M|Formoterol fumarate 12 μg via pMDI/ Placebo via DPI
1029201|NCT00746330|O1|Outcome|MFF10|Formoterol fumarate 10μg/Mometasone furoate 100μg via pMDI
1029202|NCT00746330|O4|Outcome|Placebo|Placebo via pMDI/ Placebo via DPI
1029203|NCT00746330|O3|Outcome|F12D|Placebo via pMDI/ Formoterol fumarate 12 μg via DPI
1029204|NCT00746330|O2|Outcome|F12M|Formoterol fumarate 12 μg via pMDI/ Placebo via DPI
1029205|NCT00746330|O1|Outcome|MFF10|Formoterol fumarate 10μg/Mometasone furoate 100μg via pMDI
1029206|NCT00746330|O4|Outcome|Placebo|Placebo via pMDI/ Placebo via DPI
1029207|NCT00746330|O3|Outcome|F12D|Placebo via pMDI/ Formoterol fumarate 12 μg via DPI
1029208|NCT00746330|O2|Outcome|F12M|Formoterol fumarate 12 μg via pMDI/ Placebo via DPI
1029209|NCT00746330|O1|Outcome|MFF10|Formoterol fumarate 10μg/Mometasone furoate 100μg via pMDI
1029210|NCT00746330|O4|Outcome|Placebo|Placebo via pMDI/ Placebo via DPI
1029211|NCT00746330|O3|Outcome|F12D|Placebo via pMDI/ Formoterol fumarate 12 μg via DPI
1029212|NCT00746330|O2|Outcome|F12M|Formoterol fumarate 12 μg via pMDI/ Placebo via DPI
1029213|NCT00746330|O1|Outcome|MFF10|Formoterol fumarate 10μg/Mometasone furoate 100μg via pMDI
1029220|NCT00746330|E2|Reported Event|F12D|Placebo Via pMDI/ Formoterol Fumarate 12 μg Via DPI
1029221|NCT00746330|E1|Reported Event|F12M|Formoterol Fumarate 12 μg Via pMDI/ Placebo Via DPI
1029222|NCT00746239|B1|Baseline|PD Subjects With Either Escitalopram and Placebo OR Ramelteon|Panic disorder subjects who were on Escitalopram (5-40 mg) received either Ramelteon 8 mg OR Placebo. As the study was terminated prematurely, the blind was never opened. Thus, it is not known as to how many were in each arm. As a result we are combining all subjects in one group for presenting in this record.
1029323|NCT00745095|B5|Baseline|Control MoviPrep® Only|(Control, GFR>=50ml/min) MoviPrep® only (no NG)
1030480|NCT00741598|B3|Baseline|Total|Total of all reporting groups
1029223|NCT00746239|P1|Participant Flow|PD Subjects With Either Escitalopram and Placebo OR Ramelteon|Subjects were randomly assigned to receive either Ramelteon 8 mg and Escitalopram (5-40 mg) OR Placebo and Escitalopram (5-40 mg). However, as the blind was never opened, we are combining all subjects in one group for presenting in this record.
1029224|NCT00746239|O1|Outcome|PD Subjects With Either Escitalopram and Placebo OR Ramelteon|11 subjects enrolled- 6 withdrew from study/the blind was never opened as the study was terminated prematurely for lack of continued funding- the data for outcome measures was never collected/compiled/analyzed
1029225|NCT00746239|E1|Reported Event|PD Subjects With Either Escitalopram and Placebo OR Ramelteon|"Panic disorder subjects who were on Escitalopram received either Escitalopram OR Placebo - as the study terminated prematurely, the blind was never opened; thus it is not known as to how many were in each arm- as a result we are not combining all in one group for presenting in this record.~Ramelteon and Escitalopram: Ramelteon 8 mg and Escitalopram (5-40 mg)"
1029226|NCT00746187|B3|Baseline|Total|Total of all reporting groups
1029227|NCT00746187|B2|Baseline|Biomet 3i; Osseotite® Implants|"Ø 4.0 cm in lengths 8.5-13 mm~3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm"
1029228|NCT00746187|B1|Baseline|ASTRA TECH Implant System; Fixture ST|"Ø 4.5 cm in lengths 9-13 mm~ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm."
1029229|NCT00746187|P2|Participant Flow|Biomet 3i; Osseotite® Implants|"Ø 4.0 cm in lengths 8.5-13 mm~3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm"
1029230|NCT00746187|P1|Participant Flow|ASTRA TECH Implant System; Fixture ST|"Ø 4.5 cm in lengths 9-13 mm~ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm."
1029231|NCT00746187|O2|Outcome|Biomet 3i; Osseotite® Implants|"Ø 4.0 cm in lengths 8.5-13 mm~3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm"
1029232|NCT00746187|O1|Outcome|ASTRA TECH Implant System; Fixture ST|"Ø 4.5 cm in lengths 9-13 mm~ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm."
1029233|NCT00746187|E2|Reported Event|Biomet 3i; Osseotite® Implants|"Ø 4.0 cm in lengths 8.5-13 mm~3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm"
1029234|NCT00746187|E1|Reported Event|ASTRA TECH Implant System; Fixture ST|"Ø 4.5 cm in lengths 9-13 mm~ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm."
1029235|NCT00746096|B3|Baseline|Total|Total of all reporting groups
1029236|NCT00746096|B2|Baseline|Placebo|Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg
1029237|NCT00746096|B1|Baseline|IKH-01|0.035mg ethinyl estradiol and 1 mg norethisterone
1029238|NCT00746096|P2|Participant Flow|Placebo|"Patient received placebo orally based on 28 days cycle that was consist of 21 days administration period and 7 days free of medication.~The treatment was initiated on the third day of the menstrual cycle and continued to the fourth cycle."
1029239|NCT00746096|P1|Participant Flow|IKH-01|"Patient received IKH-01 orally based on 28 days cycle that was consist of 21 days administration period and 7 days free of medication.~The treatment was initiated on the third day of the menstrual cycle and continued to the fourth cycle."
1029240|NCT00746096|O2|Outcome|Placebo|Placebo for 0.035mg ethinyl estradiol and 1 mg norethisterone
1029241|NCT00746096|O1|Outcome|IKH-01|0.035mg ethinyl estradiol and 1 mg norethisterone
1029242|NCT00746096|O2|Outcome|Placebo|Placebo for 0.035mg ethinyl estradiol and 1 mg norethisterone
1029243|NCT00746096|O1|Outcome|IKH-01|0.035mg ethinyl estradiol and 1 mg norethisterone
1029244|NCT00746096|E2|Reported Event|Placebo|Placebo for 0.035mg ethinyl estradiol and 1 mg norethisterone
1029245|NCT00746096|E1|Reported Event|IKH-01|0.035mg ethinyl estradiol and 1 mg norethisterone
1029246|NCT00745940|B3|Baseline|Total|Total of all reporting groups
1029247|NCT00745940|B2|Baseline|MBCT Control Group|Control group waited.
1029248|NCT00745940|B1|Baseline|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
1029249|NCT00745940|P2|Participant Flow|MBCT Control Group|Control group waited.
1029250|NCT00745940|P1|Participant Flow|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
1029251|NCT00745940|O2|Outcome|MBCT Control Group|Control group waited.
1029274|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
1029275|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
1029276|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
1029277|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
1029278|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
1029279|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
1030481|NCT00741598|B2|Baseline|Placebo|placebo equivalent
1029252|NCT00745940|O1|Outcome|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
1029253|NCT00745940|O2|Outcome|MBCT Control Group|Control group waited.
1029254|NCT00745940|O1|Outcome|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
1029255|NCT00745940|O2|Outcome|MBCT Control Group|Control group waited.
1029256|NCT00745940|O1|Outcome|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
1029257|NCT00745940|O2|Outcome|MBCT Control Group|Control group waited.
1029258|NCT00745940|O1|Outcome|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
1029259|NCT00745940|O2|Outcome|MBCT Control Group|Control group waited.
1029260|NCT00745940|O1|Outcome|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
1029261|NCT00745940|E2|Reported Event|MBCT Control Group|Control group waited.
1029262|NCT00745940|E1|Reported Event|MBCT Intervention Group|The curriculum of our mindfulness intervention draws upon elements from the mindfulness-based stress reduction program, and Segal and colleagues manual for mindfulness-based cognitive therapy. It was modified by one of the investigators to address issues associated with traumatic brain injury (e.g., problems with attention, concentration, memory, fatigue). The intervention was increased to ten weeks with one and a half hour weekly sessions, along with a 20-30 minute daily meditation home practice. Further adaptations included simplified language, the use of repetition to reinforce concepts, and visual aids. More attention was paid to fostering learning conditions to encourage an environment of trust and non-judgement. Connections between learning activities was also made more explicit.
1029263|NCT00745901|B3|Baseline|Total|Total of all reporting groups
1029264|NCT00745901|B2|Baseline|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
1029265|NCT00745901|B1|Baseline|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
1029266|NCT00745901|P2|Participant Flow|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
1029267|NCT00745901|P1|Participant Flow|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
1029268|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
1029269|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
1029270|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
1029271|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
1029272|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
1029273|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
1034367|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
1029281|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
1029282|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
1029283|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
1029284|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
1029285|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
1029286|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
1029287|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
1029288|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
1029289|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
1029290|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
1029291|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
1029292|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
1029293|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
1029294|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
1029295|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
1029296|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
1029297|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
1029298|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
1029299|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
1029300|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
1029301|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
1029302|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
1029303|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
1029304|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
1029305|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
1029306|NCT00745901|O2|Outcome|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
1029307|NCT00745901|O1|Outcome|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
1029308|NCT00745901|E2|Reported Event|DRSP/20mcg EE|DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients
1029309|NCT00745901|E1|Reported Event|NGM/25mcg EE|NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients
1029310|NCT00745875|B3|Baseline|Total|Total of all reporting groups
1029311|NCT00745875|B2|Baseline|ZD4054 + Pemetrexed|ZD4054 10 mg oral tablet once daily + Pemetrexed 500 mg/m2 IV infusion every 21 days
1029312|NCT00745875|B1|Baseline|Placebo + Pemetrexed|Pemetrexed 500 mg/m2 Intravenous (IV) infusion every 21 days + placebo oral tablet once daily
1029313|NCT00745875|P2|Participant Flow|ZD4054 + Pemetrexed|ZD4054 10 mg oral tablet once daily + Pemetrexed 500 mg/m2 IV infusion every 21 days
1029314|NCT00745875|P1|Participant Flow|Placebo + Pemetrexed|Pemetrexed 500 mg/m2 Intravenous (IV) infusion every 21 days + placebo oral tablet once daily
1029315|NCT00745875|O2|Outcome|ZD4054 + Pemetrexed|ZD4054 10 mg oral tablet once daily + Pemetrexed 500 mg/m2 IV infusion every 21 days
1029316|NCT00745875|O1|Outcome|Placebo + Pemetrexed|Pemetrexed 500 mg/m2 Intravenous (IV) infusion every 21 days + placebo oral tablet once daily
1032197|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
1029317|NCT00745875|O2|Outcome|ZD4054 + Pemetrexed|ZD4054 10 mg oral tablet once daily + Pemetrexed 500 mg/m2 IV infusion every 21 days
1029318|NCT00745875|O1|Outcome|Placebo + Pemetrexed|Pemetrexed 500 mg/m2 Intravenous (IV) infusion every 21 days + placebo oral tablet once daily
1029319|NCT00745875|E2|Reported Event|ZD4054 + Pemetrexed|ZD4054 10 mg oral tablet once daily + Pemetrexed 500 mg/m2 IV infusion every 21 days
1029320|NCT00745875|E1|Reported Event|Placebo + Pemetrexed|Pemetrexed 500 mg/m2 Intravenous (IV) infusion every 21 days + placebo oral tablet once daily
1029321|NCT00745095|B7|Baseline|Total|Total of all reporting groups
1029324|NCT00745095|B4|Baseline|SCI PIEE (With NG)|"(SCI, GFR>=50ml/min) PIEE (with NG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
1029325|NCT00745095|B3|Baseline|SCI PIEE (Without NG)|(SCI, GFR>=50ml/min) PIEE ( without NG)
1029326|NCT00745095|B2|Baseline|SCI MoviPrep® (With NG)|"(SCI, GFR<=50ml/min and GFR>=50ml/min) MoviPrep® (without NG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
1029327|NCT00745095|B1|Baseline|SCI MoviPrep® (Without NG)|(SCI, GFR<=50ml/min and GFR>=50ml/min) MoviPrep® (without NG)
1029328|NCT00745095|P6|Participant Flow|Control PIEE Only|(Control, GFR>=50ml/min) PIEE only (no neostigmine plus glycopyrrolate [NG])
1029329|NCT00745095|P5|Participant Flow|Control MoviPrep® Only|(Control, GFR>=50ml/min) low-volume polyethylene glycol-electrolyte lavage with ascorbic acid [MoviPrep®] only (no neostigmine plus glycopyrrolate [NG])
1029330|NCT00745095|P4|Participant Flow|SCI PIEE (With NG)|"(Spinal Cord Injury [SCI], glomerular filtration rate [GFR]>=50ml/min) pulsed irrigation enhanced evacuation (PIEE) (with neostigmine plus glycopyrrolate [NG])~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
1029331|NCT00745095|P3|Participant Flow|SCI PIEE (Without NG)|(Spinal Cord Injury [SCI], glomerular filtration rate [GFR]>=50ml/min) pulsed irrigation enhanced evacuation (PIEE) (without neostigmine plus glycopyrrolate [NG])
1029332|NCT00745095|P2|Participant Flow|SCI MoviPrep® (With NG)|"(Spinal Cord Injury [SCI], glomerular filtration rate [GFR]<=50ml/min and SCI, GFR>=50ml/min) low-volume polyethylene glycol-electrolyte lavage with ascorbic acid [MoviPrep®] (with neostigmine plus glycopyrrolate [NG])~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
1029333|NCT00745095|P1|Participant Flow|SCI MoviPrep® (Without NG)|(Spinal Cord Injury [SCI], glomerular filtration rate [GFR]<=50 and SCI, GFR>=50) low-volume polyethylene glycol-electrolyte lavage with ascorbic acid [MoviPrep®] (without neostigmine plus glycopyrrolate [NG])
1029334|NCT00745095|O6|Outcome|Control PIEE Only|(Control, GFR>=50ml/min) PIEE only (no NG)
1029335|NCT00745095|O5|Outcome|Control MoviPrep® Only|(Control, GFR>=50ml/min) MoviPrep® only (no NG)
1029336|NCT00745095|O4|Outcome|SCI PIEE (With NG)|"(SCI, GFR>=50ml/min) PIEE (with NG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
1029337|NCT00745095|O3|Outcome|SCI PIEE ( Without NG)|(SCI, GFR>=50ml/min) PIEE ( without NG)
1029338|NCT00745095|O2|Outcome|SCI MoviPrep® (With NG)|"(SCI, GFR<=50ml/min and GFR >=50ml/min) MoviPrep® (with NG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
1029339|NCT00745095|O1|Outcome|SCI MoviPrep® (Without NG)|(SCI, GFR<=50ml/min and GFR >=50ml/min) MoviPrep® ( without NG)
1029340|NCT00745095|O6|Outcome|Control PIEE Only|(Control, GFR>=50ml/min) PIEE only (no NG)
1029341|NCT00745095|O5|Outcome|Control MoviPrep® Only|(Control, GFR>=50ml/min) MoviPrep® only (no NG)
1029342|NCT00745095|O4|Outcome|SCI PIEE (With NG)|"(SCI, GFR>=50ml/min) PIEE (with NG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
1029343|NCT00745095|O3|Outcome|SCI PIEE (Without NG)|"(SCI, GFR>=50ml/min) PIEE (without NG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
1029344|NCT00745095|O2|Outcome|SCI MoviPrep® (With NG)|"(SCI, GFR<=50ml/min and GFR >=50ml/min) MoviPrep® (withNG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
1029345|NCT00745095|O1|Outcome|SCI MoviPrep® (Without NG)|(SCI, GFR<=50 and GFR >=50) MoviPrep® (without NG)
1029346|NCT00745095|E6|Reported Event|SCI PIEE Only|(Control, GFR>=50ml/min) PIEE only (no NG)
1029347|NCT00745095|E5|Reported Event|Control MoviPrep® Only|(Control, GFR>=50ml/min) MoviPrep® only (no NG)
1029348|NCT00745095|E4|Reported Event|SCI PIEE (With NG)|"(SCI, GFR>=50ml/min) PIEE (with NG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
1029349|NCT00745095|E3|Reported Event|SCI PIEE (Without NG)|(SCI, GFR>=50ml/min) PIEE ( without NG)
1029350|NCT00745095|E2|Reported Event|SCI MoviPrep® (With NG)|"(SCI, GFR<=50ml/min and GFR >=50ml/min) MoviPrep (with NG)~Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established"
1029351|NCT00745095|E1|Reported Event|SCI MoviPrep® (Without NG)|(SCI, GFR<=50ml/min and GFR >=50ml/min) MoviPrep (without NG)
1029352|NCT00745030|B3|Baseline|Total|Total of all reporting groups
1029353|NCT00745030|B2|Baseline|Placebo 8 mg Tablets|Placebo 8 mg tablets
1029354|NCT00745030|B1|Baseline|Ramelteon (TAK-375) 8mg Tablets|Ramelteon (TAK-375) 8mg tablets
1029355|NCT00745030|P2|Participant Flow|Placebo 8 mg Tablets|Placebo 8 mg tablets
1029356|NCT00745030|P1|Participant Flow|Ramelteon (TAK-375) 8mg Tablets|Ramelteon (TAK-375) 8mg tablets
1029357|NCT00745030|O2|Outcome|Placebo 8 mg Tablets|Placebo 8 mg tablets
1029358|NCT00745030|O1|Outcome|Ramelteon (TAK-375) 8mg Tablets|Ramelteon (TAK-375) 8mg tablets
1029359|NCT00745030|E2|Reported Event|Placebo 8 mg Tablets|Placebo 8 mg tablets
1029360|NCT00745030|E1|Reported Event|Ramelteon (TAK-375) 8mg Tablets|Ramelteon (TAK-375) 8mg tablets
1029361|NCT00744978|B3|Baseline|Total|Total of all reporting groups
1029362|NCT00744978|B2|Baseline|Placebo Then Varenicline|Placebo twice a day (BID) initiated with a 2-week titration regimen (Week 1: once a day [QD]; Week 2: BID), followed by varenicline 1 mg BID initiated with a 2-week titration regimen (Week 1: 0.5 mg QD; Week 2: 0.5 mg BID).
1029363|NCT00744978|B1|Baseline|Varenicline Then Placebo|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks; then placebo once daily for 1 week followed by placebo BID for 5 weeks.
1029364|NCT00744978|P2|Participant Flow|Placebo Then Varenicline|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks; then varenicline 0.5 mg once daily for 1 week followed by 0.5 mg BID for 1 week followed by 1 mg BID for 4 weeks.
1030482|NCT00741598|B1|Baseline|Galantamine-ER|16-week treatment with flexible doses (8-24mg/day)
1029365|NCT00744978|P1|Participant Flow|Varenicline Then Placebo|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks; then placebo once daily for 1 week followed by placebo BID for 5 weeks.
1029366|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
1029367|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
1029368|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
1029369|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
1029370|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
1029371|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
1029372|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
1029373|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
1029374|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
1029375|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
1029376|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
1029377|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
1029378|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
1029379|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
1029380|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
1029381|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
1029382|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
1029383|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
1029384|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
1029385|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
1029386|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
1029387|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
1029388|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
1029389|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
1029390|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
1029391|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
1029392|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
1029393|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
1029394|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
1029395|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
1029396|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
1029397|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
1029398|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
1029399|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
1029400|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
1029401|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
1029402|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
1029403|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
1029404|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
1029405|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
1032198|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
1029406|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
1029407|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
1029408|NCT00744978|O2|Outcome|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
1029409|NCT00744978|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
1029410|NCT00744978|E2|Reported Event|Placebo|Placebo once daily for 1 week followed by placebo twice daily (BID) for 5 weeks.
1029411|NCT00744978|E1|Reported Event|Varenicline|Varenicline 0.5 mg once daily for 1 week followed by 0.5 mg twice daily (BID) for 1 week followed by 1 mg BID for 4 weeks.
1029412|NCT00744939|B5|Baseline|Total|Total of all reporting groups
1029413|NCT00744939|B4|Baseline|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
1029414|NCT00744939|B3|Baseline|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
1029415|NCT00744939|B2|Baseline|Extended Moderate Renal Impairment|Participants with eGFR between >59 and ≤65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment.
1029416|NCT00744939|B1|Baseline|Mild Renal Impairment|Participants with estimated glomerular filtration rate (eGFR) >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
1029417|NCT00744939|P1|Participant Flow|Gadopentetate Dimeglumine (Magnevist, BAY86-4882)|Participants received Magnevist in accordance with its labeling.
1029418|NCT00744939|O1|Outcome|Gadopentetate Dimeglumine (Magnevist, BAY86-4882)|Participants received Magnevist in accordance with its labeling.
1029419|NCT00744939|O4|Outcome|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
1029420|NCT00744939|O3|Outcome|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
1029421|NCT00744939|O2|Outcome|Extended Moderate Renal impairmentEdit|Subjects with eGFR between >59 and ≤65 mL/min/1.73 m2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment
1029422|NCT00744939|O1|Outcome|Mild Renal Impairment|Participants with estimated glomerular filtration rate (eGFR) >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
1029423|NCT00744939|O1|Outcome|Gadopentetate Dimeglumine (Magnevist, BAY86-4882)|Participants received Magnevist in accordance with its labeling.
1029424|NCT00744939|O4|Outcome|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
1029425|NCT00744939|O3|Outcome|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
1029426|NCT00744939|O2|Outcome|Extended Moderate Renal impairmentEdit|Subjects with eGFR between >59 and ≤65 mL/min/1.73 m2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment
1029427|NCT00744939|O1|Outcome|Mild Renal Impairment|Participants with estimated glomerular filtration rate (eGFR) >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
1029428|NCT00744939|O1|Outcome|Gadopentetate Dimeglumine (Magnevist, BAY86-4882)|Participants received Magnevist in accordance with its labeling.
1029429|NCT00744939|O4|Outcome|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
1029430|NCT00744939|O3|Outcome|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
1029431|NCT00744939|O2|Outcome|Extended Moderate Renal impairmentEdit|Subjects with eGFR between >59 and ≤65 mL/min/1.73 m2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment
1029432|NCT00744939|O1|Outcome|Mild Renal Impairment|Participants with estimated glomerular filtration rate (eGFR) >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
1029433|NCT00744939|O1|Outcome|Gadopentetate Dimeglumine (Magnevist, BAY86-4882)|Participants received Magnevist in accordance with its labeling.
1029434|NCT00744939|O4|Outcome|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
1029435|NCT00744939|O3|Outcome|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
1029436|NCT00744939|O2|Outcome|Extended Moderate Renal impairmentEdit|Subjects with eGFR between >59 and ≤65 mL/min/1.73 m2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment
1029437|NCT00744939|O1|Outcome|Mild Renal Impairment|Participants with estimated glomerular filtration rate (eGFR) >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
1029438|NCT00744939|O1|Outcome|Gadopentetate Dimeglumine (Magnevist, BAY86-4882)|Participants received Magnevist in accordance with its labeling.
1029439|NCT00744939|O4|Outcome|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
1029440|NCT00744939|O3|Outcome|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
1029441|NCT00744939|O2|Outcome|Extended Moderate Renal Impairment|Participants with eGFR between >59 and ≤65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment.
1029442|NCT00744939|O1|Outcome|Mild Renal Impairment|Participants with estimated glomerular filtration rate (eGFR) >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
1032199|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
1029443|NCT00744939|O1|Outcome|Gadopentetate Dimeglumine (Magnevist, BAY86-4882)|Participants received Magnevist in accordance with its labeling.
1029444|NCT00744939|O4|Outcome|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
1029445|NCT00744939|O3|Outcome|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
1029485|NCT00745498|P1|Participant Flow|Preop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy
1029446|NCT00744939|O2|Outcome|Extended Moderate Renal Impairment|Participants with eGFR between >59 and ≤65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment.
1029447|NCT00744939|O1|Outcome|Mild Renal Impairment|Participants with estimated glomerular filtration rate (eGFR) >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
1029448|NCT00744939|E4|Reported Event|Severe Renal Impairment|Participants on dialysis or subjects with eGFR <30 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of severe renal impairment.
1029449|NCT00744939|E3|Reported Event|Moderate Renal Impairment|Participants with eGFR between ≥30 and ≤59 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of moderate renal impairment.
1029450|NCT00744939|E2|Reported Event|Extended Moderate Renal Impairment|Participants with eGFR between >59 and ≤65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of extended moderate renal impairment.
1029451|NCT00744939|E1|Reported Event|Mild Renal Impairment|Participants with eGFR >65 mL/min/1.73 m^2 prior to Magnevist injection was classified into cohort of Mild renal impairment.
1029452|NCT00745823|B3|Baseline|Total|Total of all reporting groups
1029453|NCT00745823|B2|Baseline|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
1029454|NCT00745823|B1|Baseline|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
1029455|NCT00745823|P2|Participant Flow|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
1029456|NCT00745823|P1|Participant Flow|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
1029457|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
1029458|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
1029459|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
1029460|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
1029461|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg b.i.d. administered with TRUVADA™
1029462|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg PO q.d. plus placebo to raltegravir PO b.i.d. plus one tablet of TRUVADA™ for 96 weeks
1029463|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
1029464|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
1029465|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
1029466|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
1029467|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
1029468|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
1029469|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
1029470|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
1029471|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
1029472|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
1029473|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
1029474|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
1029475|NCT00745823|O2|Outcome|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
1029476|NCT00745823|O1|Outcome|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
1029477|NCT00745823|E2|Reported Event|Raltegravir 400 mg b.i.d.|Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
1029478|NCT00745823|E1|Reported Event|Raltegravir 800 mg q.d.|Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
1029479|NCT00745498|B4|Baseline|Total|Total of all reporting groups
1029480|NCT00745498|B3|Baseline|No IVB|Patients will not receive bevacizumab before nor during vitrectomy
1029481|NCT00745498|B2|Baseline|Intraop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
1029482|NCT00745498|B1|Baseline|Preop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy
1029483|NCT00745498|P3|Participant Flow|No IVB|Patients will not receive bevacizumab before nor during vitrectomy
1029484|NCT00745498|P2|Participant Flow|Introp IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
1029486|NCT00745498|O3|Outcome|No IVB|Patients will not receive bevacizumab before nor during vitrectomy
1029487|NCT00745498|O2|Outcome|Intraop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
1029488|NCT00745498|O1|Outcome|Preop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy
1029489|NCT00745498|O3|Outcome|No IVB|Patients will not receive bevacizumab before nor during vitrectomy
1029490|NCT00745498|O2|Outcome|Intraop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
1029491|NCT00745498|O1|Outcome|Preop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy
1029492|NCT00745498|O3|Outcome|No IVB|Patients will not receive bevacizumab before nor during vitrectomy
1029493|NCT00745498|O2|Outcome|Intraop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
1029494|NCT00745498|O1|Outcome|Preop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy
1029495|NCT00745498|E3|Reported Event|No IVB|Patients will not receive bevacizumab before nor during vitrectomy
1029496|NCT00745498|E2|Reported Event|Intraop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
1029497|NCT00745498|E1|Reported Event|Preop IVB|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy
1029498|NCT00745368|B1|Baseline|Raltegravir|Raltegravir 400 mg tablets twice daily
1029499|NCT00745368|P1|Participant Flow|Raltegravir|Raltegravir 400 mg tablets twice daily
1029500|NCT00745368|O1|Outcome|Raltegravir|Raltegravir 400 mg tablets twice daily
1029501|NCT00745368|O1|Outcome|Raltegravir|Raltegravir 400 mg tablets twice daily
1029502|NCT00745368|O1|Outcome|Raltegravir|Raltegravir 400 mg tablets twice daily
1029503|NCT00745368|O1|Outcome|Raltegravir|Raltegravir 400 mg tablets twice daily
1029504|NCT00745368|O1|Outcome|Raltegravir|Raltegravir 400 mg tablets twice daily
1029505|NCT00745368|O1|Outcome|Raltegravir|Raltegravir 400 mg tablets twice daily
1029506|NCT00745368|O1|Outcome|Raltegravir|Raltegravir 400 mg tablets twice daily
1029507|NCT00745368|O1|Outcome|Raltegravir|Raltegravir 400 mg tablets twice daily
1029508|NCT00745368|E1|Reported Event|Raltegravir|Raltegravir 400 mg tablets twice daily
1029509|NCT00745290|B3|Baseline|Total|Total of all reporting groups
1029510|NCT00745290|B2|Baseline|SKY0402|randomized in a 1:1 ratio to receive 600 mg SKY0402 (study drug) and stratified by site and by modality.
1029511|NCT00745290|B1|Baseline|Bupivacaine HCl|randomized in a 1:1 ratio to receive 200 mg bupivacaine HCl and stratified by site and by modality.
1029512|NCT00745290|P2|Participant Flow|SKY0402|randomized in a 1:1 ratio to receive 600 mg SKY0402 (study drug) and stratified by site and by modality.
1029513|NCT00745290|P1|Participant Flow|Bupivacaine HCl|randomized in a 1:1 ratio to receive 200 mg bupivacaine HCl and stratified by site and by modality.
1029514|NCT00745290|O2|Outcome|SKY0402|randomized in a 1:1 ratio to receive 600 mg SKY0402 (study drug) and stratified by site and by modality.
1029515|NCT00745290|O1|Outcome|Bupivacaine HCl|randomized in a 1:1 ratio to receive 200 mg bupivacaine HCl and stratified by site and by modality.
1029516|NCT00745290|E2|Reported Event|SKY0402|randomized in a 1:1 ratio to receive 600 mg SKY0402 (study drug) and stratified by site and by modality.
1029517|NCT00745290|E1|Reported Event|Bupivacaine HCl|randomized in a 1:1 ratio to receive 200 mg bupivacaine HCl and stratified by site and by modality.
1029518|NCT00745251|B3|Baseline|Total|Total of all reporting groups
1029519|NCT00745251|B2|Baseline|Top Dose|PHEN/TPM 15mg/92mg
1029520|NCT00745251|B1|Baseline|Placebo|
1029521|NCT00745251|P2|Participant Flow|Top Dose|PHEN/TPM 15mg/92mg
1029522|NCT00745251|P1|Participant Flow|Placebo|
1029523|NCT00745251|O2|Outcome|Top Dose|PHEN/TPM 15mg/92mg
1029524|NCT00745251|O1|Outcome|Placebo|
1029525|NCT00745251|O2|Outcome|Top Dose|PHEN/TPM 15mg/92mg
1029526|NCT00745251|O1|Outcome|Placebo|
1029527|NCT00745251|E2|Reported Event|Top Dose|PHEN/TPM 15mg/92mg
1029528|NCT00745251|E1|Reported Event|Placebo|
1029529|NCT00744874|B1|Baseline|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
1029530|NCT00744874|P1|Participant Flow|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
1029531|NCT00744874|O1|Outcome|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
1029532|NCT00744874|O1|Outcome|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
1029533|NCT00744874|O1|Outcome|Cumulative Radio Frequency Time for PV Isolation|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
1029534|NCT00744874|O3|Outcome|Quality of Life Scores at 6 Months|Quality of life scores at 6 months or 6 months before pulmonary vein isolation procedure was performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
1029591|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1029535|NCT00744874|O2|Outcome|Quality of Life Scores at 3 Months|Quality of life scores at 3 months or 3 months before pulmonary vein isolation procedure was performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
1029536|NCT00744874|O1|Outcome|Baseline Quality of Life Scores|Quality of life scores at baseline or before pulmonary vein isolation procedure was performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
1029597|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1029598|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1029537|NCT00744874|O3|Outcome|Ablated Patients Symptom Severity Score at 6 Months|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.Measured scores at 6 months after the procedure.
1029538|NCT00744874|O2|Outcome|Ablated Patients Symptom Severity Score at 3 Months|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.Measured scores at 3 months after the procedure.
1029539|NCT00744874|O1|Outcome|Ablated Patients Symptom Severity Score at Baseline|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.Measured scores at baseline.
1029540|NCT00744874|O1|Outcome|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
1029541|NCT00744874|O1|Outcome|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
1029542|NCT00744874|O1|Outcome|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
1029543|NCT00744874|O1|Outcome|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
1029544|NCT00744874|E1|Reported Event|Ablated Participants|Participants that who had a pulmonary vein isolation procedure performed with the Medtronic Ablation Frontiers® Cardiac Ablation System for the treatment of atrial fibrillation.
1029545|NCT00744848|B3|Baseline|Total|Total of all reporting groups
1029546|NCT00744848|B2|Baseline|SKY0402|Single administration 300 mg SKY0402 in a 40-mL injection volume via local infiltration.
1029547|NCT00744848|B1|Baseline|Bupivacaine HCl|100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402.
1029548|NCT00744848|P2|Participant Flow|SKY0402|Single administration 300 mg SKY0402 in a 40-mL injection volume via local infiltration.
1029549|NCT00744848|P1|Participant Flow|Bupivacaine HCl|100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402.
1029550|NCT00744848|O2|Outcome|SKY0402|Single administration 300 mg SKY0402 in a 40-mL injection volume via local infiltration.
1029551|NCT00744848|O1|Outcome|Bupivacaine HCl|100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402.
1029552|NCT00744848|E2|Reported Event|SKY0402|Single administration 300 mg SKY0402 in a 40-mL injection volume via local infiltration.
1029553|NCT00744848|E1|Reported Event|Bupivacaine HCl|100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402.
1029554|NCT00744757|B1|Baseline|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
1029555|NCT00744757|P1|Participant Flow|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
1029556|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
1029557|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
1029558|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
1029559|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
1029560|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
1029561|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
1029592|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1029593|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1029562|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
1029599|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1029563|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
1029564|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
1029565|NCT00744757|O1|Outcome|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
1029566|NCT00744757|E1|Reported Event|Decitabine|Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
1029567|NCT00744692|B1|Baseline|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
1029568|NCT00744692|P1|Participant Flow|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
1029569|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
1029570|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
1029571|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
1029572|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
1029573|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
1029574|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
1029575|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
1029576|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
1029577|NCT00744692|O1|Outcome|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
1029578|NCT00744692|E1|Reported Event|RIC Cord Blood Transplant|"Reduced Intensity Conditioning for Umbilical Cord Blood Transplant~Unrelated Umbilical Cord Blood Transplant: Reduced Intensity Conditioning for unrelated umbilical cord blood transplant~Reduced Intensity Conditioning"
1029579|NCT00744653|B1|Baseline|Electrochemotherapy|Patients with local-regional recurrence of breast cancer, lesion over 3 cm. Treatment with electric pulses combined with bleomycin. Pulse duration 100 microseconds, about 400 V given at 5000 Hz.
1029580|NCT00744653|P1|Participant Flow|Electrochemotherapy|Patients with local-regional recurrence of breast cancer, lesion over 3 cm. Treatment with electric pulses combined with bleomycin. Pulse duration 100 microseconds, about 400 V given at 5000 Hz.
1029581|NCT00744653|O1|Outcome|Electrochemotherapy|Patients with local-regional recurrence of breast cancer, lesion over 3 cm. Treatment with electric pulses combined with bleomycin. Pulse duration 100 microseconds, about 400 V given at 5000 Hz.
1029582|NCT00744653|O1|Outcome|Electrochemotherapy|All patients treated with electrochemotherapy
1029583|NCT00744653|O1|Outcome|Electrochemotherapy|Patients with local-regional recurrence of breast cancer, lesion over 3 cm. Treatment with electric pulses combined with bleomycin. Pulse duration 100 microseconds, about 400 V given at 5000 Hz.
1029584|NCT00744653|E1|Reported Event|Electrochemotherapy|Patients with local-regional recurrence of breast cancer, lesion over 3 cm. Treatment with electric pulses combined with bleomycin. Pulse duration 100 microseconds, about 400 V given at 5000 Hz.
1029585|NCT00744627|B3|Baseline|Total|Total of all reporting groups
1029586|NCT00744627|B2|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1029587|NCT00744627|B1|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1029588|NCT00744627|P2|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1029589|NCT00744627|P1|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1029590|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1029594|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1029595|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1029596|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1029600|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1029601|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1029602|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1029603|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1029604|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1029605|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1029606|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1029607|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1029608|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1029609|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1029610|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1029611|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1029612|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1029613|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1029614|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1029615|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1029616|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1029617|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1029618|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1029619|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1029620|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1029621|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1029622|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1029623|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1029624|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1029625|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1029626|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1029627|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1029628|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1029629|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1029630|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1029631|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1029632|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1029633|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1029634|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1029635|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1029636|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1029637|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1029638|NCT00744627|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1029639|NCT00744627|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1029640|NCT00744627|E2|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1029641|NCT00744627|E1|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1029642|NCT00744523|B3|Baseline|Total|Total of all reporting groups
1029643|NCT00744523|B2|Baseline|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
1029644|NCT00744523|B1|Baseline|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
1034368|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
1029645|NCT00744523|P2|Participant Flow|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
1029646|NCT00744523|P1|Participant Flow|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
1029741|NCT00744263|O2|Outcome|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
1030483|NCT00741598|P2|Participant Flow|Placebo|placebo equivalent
1029647|NCT00744523|O2|Outcome|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
1029648|NCT00744523|O1|Outcome|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
1029649|NCT00744523|O2|Outcome|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
1029650|NCT00744523|O1|Outcome|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
1029651|NCT00744523|O2|Outcome|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
1029652|NCT00744523|O1|Outcome|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
1029653|NCT00744523|O2|Outcome|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
1029654|NCT00744523|O1|Outcome|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
1029655|NCT00744523|O2|Outcome|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
1029656|NCT00744523|O1|Outcome|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
1029657|NCT00744523|O2|Outcome|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
1029658|NCT00744523|O1|Outcome|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
1029659|NCT00744523|O2|Outcome|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA device.
1029660|NCT00744523|O1|Outcome|MO.MA Training Cases (Roll-In)|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfill the eligibility criteria will be screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
1029661|NCT00744523|E2|Reported Event|MO.MA Pivotal Subjects|All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
1029662|NCT00744523|E1|Reported Event|MO.MA Roll-In Cases|All subjects who were enrolled prior to the pivotal phase of the trial at each US site. All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA proximal flow blockage cerebral protection device
1029663|NCT00744497|B3|Baseline|Total|Total of all reporting groups
1029664|NCT00744497|B2|Baseline|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029665|NCT00744497|B1|Baseline|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029666|NCT00744497|P2|Participant Flow|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029667|NCT00744497|P1|Participant Flow|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029668|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029669|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029670|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029671|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029672|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029673|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029745|NCT00744263|O2|Outcome|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
1029674|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029675|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029676|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029677|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029678|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029679|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029680|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029681|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029682|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029683|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029684|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029685|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029686|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029687|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029688|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029689|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029690|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029691|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029692|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029693|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029694|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029695|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029696|NCT00744497|O2|Outcome|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029697|NCT00744497|O1|Outcome|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029698|NCT00744497|E2|Reported Event|Dasatinib|Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029699|NCT00744497|E1|Reported Event|Placebo|Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
1029700|NCT00744380|B3|Baseline|Total|Total of all reporting groups
1029701|NCT00744380|B2|Baseline|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
1029702|NCT00744380|B1|Baseline|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
1029703|NCT00744380|P2|Participant Flow|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
1029704|NCT00744380|P1|Participant Flow|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
1029705|NCT00744380|O2|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
1029706|NCT00744380|O1|Outcome|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
1029707|NCT00744380|O2|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
1029708|NCT00744380|O1|Outcome|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
1029709|NCT00744380|O2|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
1029710|NCT00744380|O1|Outcome|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
1029711|NCT00744380|O2|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
1029712|NCT00744380|O1|Outcome|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
1029713|NCT00744380|O2|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
1029714|NCT00744380|O1|Outcome|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
1029740|NCT00744263|P1|Participant Flow|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
1032200|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
1029742|NCT00744263|O1|Outcome|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
1029743|NCT00744263|O2|Outcome|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
1029744|NCT00744263|O1|Outcome|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
1029715|NCT00744380|O2|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
1029716|NCT00744380|O1|Outcome|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
1029717|NCT00744380|O2|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
1029718|NCT00744380|O1|Outcome|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
1029719|NCT00744380|O2|Outcome|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
1029720|NCT00744380|O1|Outcome|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
1029721|NCT00744380|E2|Reported Event|Dexmedetomidine|"Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.~Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
1029722|NCT00744380|E1|Reported Event|Midazolam|"Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.~Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)"
1029723|NCT00744328|B4|Baseline|Total|Total of all reporting groups
1029724|NCT00744328|B3|Baseline|Placebo|Placebo: Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
1029725|NCT00744328|B2|Baseline|Sertraline|"Administered via capsules taken orally ranging in dose from 25 to 200mg/day~Sertraline: Sertraline dose will range from 50 - 200 mg/day"
1029726|NCT00744328|B1|Baseline|Estradiol|"Administered via skin patch ranging in dose from 50 to 200 mcg/day~Transdermal Estradiol: Estradiol patch ranging in dose from 50 to 200 mcg/day"
1029727|NCT00744328|P3|Participant Flow|Placebo|Placebo: Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
1029728|NCT00744328|P2|Participant Flow|Sertraline|"Administered via capsules taken orally ranging in dose from 25 to 200mg/day~Sertraline: Sertraline dose will range from 50 - 200 mg/day"
1029729|NCT00744328|P1|Participant Flow|Estradiol|"Administered via skin patch ranging in dose from 50 to 200 mcg/day~Transdermal Estradiol: Estradiol patch ranging in dose from 50 to 200 mcg/day"
1029730|NCT00744328|O3|Outcome|Placebo|Placebo: Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
1029731|NCT00744328|O2|Outcome|Sertraline|"Administered via capsules taken orally ranging in dose from 25 to 200mg/day~Sertraline: Sertraline dose will range from 50 - 200 mg/day"
1029732|NCT00744328|O1|Outcome|Estradiol|"Administered via skin patch ranging in dose from 50 to 200 mcg/day~Transdermal Estradiol: Estradiol patch ranging in dose from 50 to 200 mcg/day"
1029733|NCT00744328|E3|Reported Event|Placebo|Placebo: Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
1029734|NCT00744328|E2|Reported Event|Sertraline|"Administered via capsules taken orally ranging in dose from 25 to 200mg/day~Sertraline: Sertraline dose will range from 50 - 200 mg/day"
1029735|NCT00744328|E1|Reported Event|Estradiol|"Administered via skin patch ranging in dose from 50 to 200 mcg/day~Transdermal Estradiol: Estradiol patch ranging in dose from 50 to 200 mcg/day"
1029736|NCT00744263|B3|Baseline|Total|Total of all reporting groups
1029737|NCT00744263|B2|Baseline|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
1029738|NCT00744263|B1|Baseline|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
1029739|NCT00744263|P2|Participant Flow|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
1029746|NCT00744263|O1|Outcome|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
1029747|NCT00744263|O2|Outcome|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
1029748|NCT00744263|O1|Outcome|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
1029749|NCT00744263|O2|Outcome|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
1029750|NCT00744263|O1|Outcome|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
1029751|NCT00744263|O2|Outcome|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
1029752|NCT00744263|O1|Outcome|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
1029753|NCT00744263|O2|Outcome|Placebo|Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
1029754|NCT00744263|O1|Outcome|13vPnC|Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1.
1029755|NCT00744263|E4|Reported Event|Placebo Immunogenicity Subset|Participants included in immunogenicity subset who received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1, were assessed for SAEs from 1 month after vaccination up to 6 months after vaccination and for Other AEs from vaccination up to 1 month after vaccination. Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures.
1029756|NCT00744263|E3|Reported Event|13vPnC Immunogenicity Subset|Participants included in immunogenicity subset who received a single 0.5 mL dose of 13vPnC intramuscular injection on Day 1, were assessed for SAEs from 1 month after vaccination up to 6 months after vaccination and for Other adverse events (AEs) from vaccination up to 1 month after vaccination. Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures.
1029757|NCT00744263|E2|Reported Event|Placebo Safety Set|All participants who received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1, were assessed for SAEs from vaccination up to 1 month after vaccination. Safety set included all participants who received study vaccine and who had any safety data.
1029758|NCT00744263|E1|Reported Event|13vPnC Safety Set|All Participants who received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1, were assessed for serious adverse events (SAEs) from vaccination up to 1 month after vaccination. Safety set included all participants who received study vaccine and who had any safety data.
1029759|NCT00744237|B4|Baseline|Total|Total of all reporting groups
1029760|NCT00744237|B3|Baseline|Hydrochlorothiazide (HCTZ)|"HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration~HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration~Open-label amlodipine may be given"
1029761|NCT00744237|B2|Baseline|Metoprolol ER|"Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration~Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration~Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration~Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration~Open-label amlodipine may be given"
1029762|NCT00744237|B1|Baseline|Nebivolol|"Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration~Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration~Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration~Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration~Open-label amlodipine may be given"
1029763|NCT00744237|P3|Participant Flow|Hydrochlorothiazide (HCTZ)|"HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration~HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration~Open-label amlodipine may be given"
1029764|NCT00744237|P2|Participant Flow|Metoprolol ER|"Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration~Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration~Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration~Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration~Open-label amlodipine may be given"
1029765|NCT00744237|P1|Participant Flow|Nebivolol|"Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration~Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration~Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration~Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration~Open-label amlodipine may be given"
1029766|NCT00744237|O3|Outcome|Hydrochlorothiazide (HCTZ)|"HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration~HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration~Open-label amlodipine may be given"
1029767|NCT00744237|O2|Outcome|Metoprolol ER|"Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration~Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration~Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration~Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration~Open-label amlodipine may be given"
1029768|NCT00744237|O1|Outcome|Nebivolol|"Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration~Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration~Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration~Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration~Open-label amlodipine may be given"
1030576|NCT00741156|O6|Outcome|Cerebral Blood Flow After Enalaprilat|Cerebral blood flow 20 minutes after enalaprilat
1029769|NCT00744237|O3|Outcome|Hydrochlorothiazide (HCTZ)|"HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration~HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration~Open-label amlodipine may be given"
1029770|NCT00744237|O2|Outcome|Metoprolol ER|"Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration~Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration~Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration~Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration~Open-label amlodipine may be given"
1029945|NCT00743288|P3|Participant Flow|Melphalan and Panobinostat Schedule B2|20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of week 1.
1029771|NCT00744237|O1|Outcome|Nebivolol|"Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration~Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration~Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration~Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration~Open-label amlodipine may be given"
1029772|NCT00744237|E3|Reported Event|Hydrochlorothiazide (HCTZ)|"HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration~HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration~Open-label amlodipine may be given"
1029773|NCT00744237|E2|Reported Event|Metoprolol ER|"Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration~Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration~Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration~Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration~Open-label amlodipine may be given"
1029774|NCT00744237|E1|Reported Event|Nebivolol|"Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration~Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration~Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration~Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration~Open-label amlodipine may be given"
1029775|NCT00744055|B3|Baseline|Total|Total of all reporting groups
1029776|NCT00744055|B2|Baseline|Placebo|men or women, ages of 21-65, met DSM-IV criteria for current PTSD and alcohol dependence (AD) (determined by structured clinical interview)
1029777|NCT00744055|B1|Baseline|Prazosin|men or women, ages of 21-65, met DSM-IV criteria for current PTSD and alcohol dependence (AD) (determined by structured clinical interview)
1029778|NCT00744055|P2|Participant Flow|Placebo|"Placebo in identical looking capsule blister packs~Placebo: Placebo"
1029779|NCT00744055|P1|Participant Flow|Prazosin|"prazosin (16mg/day)~Prazosin: prazosin (16mg/day) 2 times a day"
1029780|NCT00744055|O2|Outcome|Placebo|"Placebo in identical looking capsule blister packs~Placebo"
1029781|NCT00744055|O1|Outcome|Prazosin|"prazosin (16mg/day)~Prazosin: prazosin (16mg/day) 2 times a day"
1029782|NCT00744055|O2|Outcome|Placebo|"Placebo in identical looking capsule blister packs~Placebo"
1029783|NCT00744055|O1|Outcome|Prazosin|"prazosin (16mg/day)~Prazosin: prazosin (16mg/day) 2 times a day"
1029784|NCT00744055|E2|Reported Event|Placebo|"Placebo in identical looking capsule blister packs~Placebo"
1029785|NCT00744055|E1|Reported Event|Prazosin|"prazosin (16mg/day)~Prazosin: prazosin (16mg/day) 2 times a day"
1029786|NCT00744042|B1|Baseline|Asfotase Alfa|All enrolled patients receive a single IV (intravenous) dose of Asfotase Alfa of 2 mg/kg followed by 7 days of observation. Following an assessment of safety data by an independent Data Safety Monitoring Board (DSMB), patients begin thrice weekly SC (subcutaneous) injections of Asfotase Alfa at a dose of 1 mg/kg for the remaining 23 weeks of the study.
1029787|NCT00744042|P1|Participant Flow|Asfotase Alfa|All patients received an initial single intravenous (IV) infusion of 2 mg/kg asfotase alfa for the first week followed by regular administration of subcutaneous (SC) injections of 1 mg/kg asfotase alfa 3 times/week (total 3 mg/kg/week).
1029788|NCT00744042|O3|Outcome|Study Week 3 Subcutaneous Dose (1mg/kg 3x/Week)|Participants received subcutaneous (SC) asfotase alfa starting on Day 8 (Week 2) (1 mg/kg 3x/week). PK samples drawn predose to 48 hours post-dose for PK analysis following multiple SC doses.
1029789|NCT00744042|O2|Outcome|Study Week 2 Subcutaneous Dose (1mg/kg 3x/Week)|Participants received subcutaneous (SC) asfotase alfa starting on Day 8 (Week 2) (1 mg/kg 3x/week). PK samples drawn predose to 48 hours post-dose for PK analysis following single SC dose.
1029790|NCT00744042|O1|Outcome|Study Week 1 Intravenous Dose (2mg/kg Single Dose)|Participants received intravenous (IV) asfotase alfa (2mg/mg single dose) on Day 1. PK samples drawn predose to 168 hours post-dose.
1029791|NCT00744042|O3|Outcome|Study Week 3 Subcutaneous Dose (1mg/kg 3x/Week)|Participants received subcutaneous (SC) asfotase alfa starting on Day 8 (Week 2) (1 mg/kg 3x/week). PK samples drawn predose to 48 hours post-dose for PK analysis following multiple SC doses.
1029792|NCT00744042|O2|Outcome|Study Week 2 Subcutaneous Dose (1 mg/kg 3x/Week)|Participants received subcutaneous (SC) asfotase alfa starting on Day 8 (Week 2) (1 mg/kg 3x/week). PK samples drawn predose to 48 hours post-dose for PK analysis following single SC dose.
1029793|NCT00744042|O1|Outcome|Study Week 1 Intravenous Dose (2 mg/kg Single Dose)|Participants received intravenous (IV) asfotase alfa (2 mg/kg single dose) on Day 1. PK samples drawn predose to 168 hours post-dose.
1029794|NCT00744042|O3|Outcome|Study Week 3 Subcutaneous Dose (1 mg/kg 3x/Week)|Participants received subcutaneous (SC) asfotase alfa starting on Day 8 (Week 2) (1 mg/kg 3x/week). PK samples drawn predose to 48 hours post-dose for PK analysis following multiple SC doses.
1029795|NCT00744042|O2|Outcome|Study Week 2 Subcutaneous Dose (1 mg/kg 3x/Week)|Participants received subcutaneous (SC) asfotase alfa starting on Day 8 (Week 2) (1 mg/kg 3x/week). PK samples drawn predose to 48 hours post-dose for PK analysis following single SC dose.
1029796|NCT00744042|O1|Outcome|Study Week 1 Intravenous Dose (2 mg/kg Single Dose)|Participants received intravenous (IV) asfotase alfa (2 mg/kg single dose) on Day 1. PK samples drawn predose to 168 hours post-dose.
1029797|NCT00744042|O1|Outcome|Asfotase Alfa|All HPP affected infants will receive a single IV (intravenous) dose of Asfotase Alfa of 2 mg/kg followed by 7 days of observation. Following an assessment of safety data by an independent Data Safety Monitoring Board (DSMB), patients will then begin every other day SC (subcutaneous) injections of Asfotase Alfa at a dose of 1 mg/kg for 23 weeks. End of Study will be at 24 weeks.
1029798|NCT00744042|E1|Reported Event|Asfotase Alfa|All patients who received any asfotase alfa treatment, regardless of whether they were lost to follow-up or dropped out of the trial.
1029799|NCT00743730|B4|Baseline|Total|Total of all reporting groups
1029944|NCT00743288|P4|Participant Flow|Melphalan and Panobinostat Schedule C|20 mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1 and 2 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of week 1.
1029800|NCT00743730|B3|Baseline|III PRN Intermittent|"Intermittent opioid administered IV on an as needed basis~Pain and standard side effect management with IV on an as needed basis method.: Comparing pain management and parent and nurse satisfaction with pain medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol."
1030484|NCT00741598|P1|Participant Flow|Galantamine-ER|16-week treatment with flexible doses (8-24mg/day)
1029801|NCT00743730|B2|Baseline|II PNCA w/o Basal|"Parent and Nurse Controlled Analgesics without basal~Pain and standard side effect management with PNCA without basal: Comparing pain management and parent nurse satisfaction with pain mediation delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
1029802|NCT00743730|B1|Baseline|I PNCA With Basal|"Parent and Nurse Controlled Analgesics with basal~Pain and standard side effect management for PNCA with basal method.: Comparing pain management and parent and nurse satisfaction with medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
1029803|NCT00743730|P3|Participant Flow|Medication as Needed|"Intermittent opioid administered IV on an as needed basis~Pain and standard side effect management with IV on an as needed basis method.: Comparing pain management and parent and nurse satisfaction with pain medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol."
1029804|NCT00743730|P2|Participant Flow|PNCA w/o Basal|"Parent and Nurse Controlled Analgesics without basal~Pain and standard side effect management with PNCA without basal: Comparing pain management and parent nurse satisfaction with pain mediation delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
1029805|NCT00743730|P1|Participant Flow|PNCA With Basal|"Parent and Nurse Controlled Analgesics with basal~Pain and standard side effect management for PNCA with basal method.: Comparing pain management and parent and nurse satisfaction with medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
1029806|NCT00743730|O3|Outcome|III PRN Intermittent|"Intermittent opioid administered IV on an as needed basis~Pain and standard side effect management with IV on an as needed basis method.: Comparing pain management and parent and nurse satisfaction with pain medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol."
1029807|NCT00743730|O2|Outcome|II PNCA w/o Basal|"Parent and Nurse Controlled Analgesics without basal~Pain and standard side effect management with PNCA without basal: Comparing pain management and parent nurse satisfaction with pain mediation delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
1029808|NCT00743730|O1|Outcome|I PNCA With Basal|"Parent and Nurse Controlled Analgesics with basal~Pain and standard side effect management for PNCA with basal method.: Comparing pain management and parent and nurse satisfaction with medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
1029809|NCT00743730|O3|Outcome|Intermittent Opioid on as Needed Basis|"Intermittent opioid administered IV on an as needed basis~Pain and standard side effect management with IV on an as needed basis method.: Comparing pain management and parent and nurse satisfaction with pain medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol."
1029810|NCT00743730|O2|Outcome|PNCA Without Basal|"Parent and Nurse Controlled Analgesics without basal~Pain and standard side effect management with PNCA without basal: Comparing pain management and parent nurse satisfaction with pain mediation delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
1029811|NCT00743730|O1|Outcome|PNCA With Basal|"Parent and Nurse Controlled Analgesics with basal~Pain and standard side effect management for PNCA with basal method.: Comparing pain management and parent and nurse satisfaction with medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
1029812|NCT00743730|E3|Reported Event|III PRN Intermittent|"Intermittent opioid administered IV on an as needed basis~Pain and standard side effect management with IV on an as needed basis method.: Comparing pain management and parent and nurse satisfaction with pain medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol."
1029840|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
1034369|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
1029813|NCT00743730|E2|Reported Event|II PNCA w/o Basal|"Parent and Nurse Controlled Analgesics without basal~Pain and standard side effect management with PNCA without basal: Comparing pain management and parent nurse satisfaction with pain mediation delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
1029814|NCT00743730|E1|Reported Event|I PNCA With Basal|"Parent and Nurse Controlled Analgesics with basal~Pain and standard side effect management for PNCA with basal method.: Comparing pain management and parent and nurse satisfaction with medication delivery. Standard side effects of nausea, vomiting and pruritis can be expected although not always present. Protocol is in place to treat and manage these side effects.~Only PAIN TEAM will be writing analgesic orders and will make medication adjustment per protocol. PCA teaching will be done per Policy and Procedure."
1029815|NCT00743717|B3|Baseline|Total|Total of all reporting groups
1029816|NCT00743717|B2|Baseline|2: CoCr Femoral|cobalt chrome femoral component : total knee arthroplasty performed using implant with cobalt chrome femoral component
1029817|NCT00743717|B1|Baseline|1: Zirconia Femoral|zirconia femoral component : total knee arthroplasty performed using implant with zirconia femoral component
1029818|NCT00743717|P2|Participant Flow|2: CoCr Femoral|cobalt chrome femoral component : total knee arthroplasty performed using implant with cobalt chrome femoral component
1029819|NCT00743717|P1|Participant Flow|1: Zirconia Femoral|zirconia femoral component : total knee arthroplasty performed using implant with zirconia femoral component
1029820|NCT00743717|O2|Outcome|2: CoCr Femoral|cobalt chrome femoral component : total knee arthroplasty performed using implant with cobalt chrome femoral component
1029821|NCT00743717|O1|Outcome|1: Zirconia Femoral|zirconia femoral component : total knee arthroplasty performed using implant with zirconia femoral component
1029822|NCT00743717|E2|Reported Event|2: CoCr Femoral|cobalt chrome femoral component : total knee arthroplasty performed using implant with cobalt chrome femoral component
1029823|NCT00743717|E1|Reported Event|1: Zirconia Femoral|zirconia femoral component : total knee arthroplasty performed using implant with zirconia femoral component
1029824|NCT00743652|B6|Baseline|Total|Total of all reporting groups
1029825|NCT00743652|B5|Baseline|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
1029826|NCT00743652|B4|Baseline|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
1029827|NCT00743652|B3|Baseline|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
1029828|NCT00743652|B2|Baseline|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
1029829|NCT00743652|B1|Baseline|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
1029830|NCT00743652|P5|Participant Flow|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
1029831|NCT00743652|P4|Participant Flow|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
1029832|NCT00743652|P3|Participant Flow|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
1029833|NCT00743652|P2|Participant Flow|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
1029834|NCT00743652|P1|Participant Flow|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
1029835|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
1029836|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
1029837|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
1029838|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
1029839|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
1029980|NCT00743249|B2|Baseline|Canalicular Stent, 20 mm|MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
1029841|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
1029983|NCT00743249|P1|Participant Flow|Canalicular Stent, 10 mm|MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
1029842|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
1029843|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
1029844|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
1029845|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
1029846|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
1029847|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
1029848|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
1029849|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
1029850|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
1029851|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
1029852|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
1029853|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
1029854|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
1029855|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
1029856|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
1029857|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
1029858|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
1029859|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
1029860|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
1029861|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
1029862|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
1029888|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
1029946|NCT00743288|P2|Participant Flow|Melphalan and Panobinostat Schedule B1|10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of week 1.
1030485|NCT00741598|O2|Outcome|Placebo|placebo equivalent
1029863|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
1029864|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
1029865|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
1029866|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
1029867|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
1029868|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
1029869|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
1029870|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
1029871|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
1029872|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
1029873|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
1029874|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
1029875|NCT00743652|O1|Outcome|13vPnC (All Participants)|All participants 6 weeks to <5 years of age who received at least one single IM 0.5 mL dose of 13vPnC in either the infant series or the toddler dose.
1029876|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
1029877|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
1029878|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
1029879|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
1029880|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
1029881|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
1029882|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
1029883|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
1029884|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
1029885|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
1029886|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
1029887|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
1029889|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
1029890|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
1029891|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
1029892|NCT00743652|O2|Outcome|13vPnC Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
1029893|NCT00743652|O1|Outcome|13vPnC Group 4 (2 Catch-Up Doses)|Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
1029894|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
1029895|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
1029896|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
1029897|NCT00743652|O3|Outcome|13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
1029898|NCT00743652|O2|Outcome|13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
1029899|NCT00743652|O1|Outcome|13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)|Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
1029900|NCT00743652|E8|Reported Event|Group 5 (1 Catch-Up Dose)|Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
1029901|NCT00743652|E7|Reported Event|Group 4 (2 Catch-Up Doses)|Participants ≥12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
1029902|NCT00743652|E6|Reported Event|Group 3 (Toddler Dose)|Participants >12 months of age received a single IM 0.5 mL dose of 13vPnC at least 60 days after last infant dose (toddler dose)
1029903|NCT00743652|E5|Reported Event|Group 2 (Toddler Dose)|Participants >12 months of age received a single IM 0.5 mL dose of 13vPnC at least 60 days after last infant dose (toddler dose)
1029904|NCT00743652|E4|Reported Event|Group 1 (Toddler Dose)|Participants >12 months of age received a single IM 0.5 mL dose of 13vPnC at least 60 days after last infant dose (toddler dose)
1029905|NCT00743652|E3|Reported Event|Group 3 (Infant Series)|Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series)
1029906|NCT00743652|E2|Reported Event|Group 2 (Infant Series)|Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series)
1029907|NCT00743652|E1|Reported Event|Group 1 (Infant Series)|Participants 6 weeks to <10 months of age with 0 prior doses of Prevnar received 3 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series).
1029908|NCT00743574|B1|Baseline|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)~Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)~Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)~Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
1029909|NCT00743574|P1|Participant Flow|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)~Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)~Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)~Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
1029910|NCT00743574|O1|Outcome|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)~Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)~Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)~Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
1029911|NCT00743574|O1|Outcome|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)~Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)~Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)~Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
1029912|NCT00743574|O1|Outcome|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)~Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)~Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)~Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
1029943|NCT00743288|P5|Participant Flow|Melphalan and Panobinostat Schedule D1|15 mg/daily of LBH589 PO and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of weeks 1 of a 28-day cycle
1029913|NCT00743574|O1|Outcome|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)~Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)~Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)~Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
1029914|NCT00743574|O1|Outcome|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)~Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)~Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)~Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
1029915|NCT00743574|O1|Outcome|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)~Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)~Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)~Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
1029916|NCT00743574|E1|Reported Event|Vitamin D Plus Calcium (Ca) Supplementation|"Vitamin D3 (Cholecalciferol) : 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)~Elemental Calcium : 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)~Vitamin D2 (Ergocalciferol) : 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)~Medroxyprogesterone (Provera) : 10mg, PO, daily for ten days"
1029917|NCT00743509|B1|Baseline|Oral Cyclophosphamide and Sirolimus (OCR)|"Sarcoma patients were given oral Cyclophosphamide and Sirolimus (OCR) in 28 day cycles.~Cyclophosphamide and Sirolimus : The dose of cyclophosphamide will start at 200 mg (4 tablets) per day on day 1 and will be taken for 7 days every other week of a 28 day cycle.~Subjects will take 12 mg (12 tablets) of sirolimus on day 1 of treatment as a loading dose followed by 4 mg (4 tablets) daily continuously"
1029918|NCT00743509|P1|Participant Flow|Oral Cyclophosphamide and Sirolimus (OCR)|"Sarcoma patients were given oral Cyclophosphamide and Sirolimus (OCR) in 28 day cycles.~Cyclophosphamide and Sirolimus : The dose of cyclophosphamide will start at 200 mg (4 tablets) per day on day 1 and will be taken for 7 days every other week of a 28 day cycle.~Subjects will take 12 mg (12 tablets) of sirolimus on day 1 of treatment as a loading dose followed by 4 mg (4 tablets) daily continuously"
1029919|NCT00743509|O1|Outcome|Oral Cyclophosphamide and Sirolimus (OCR)|"Sarcoma patients were given oral Cyclophosphamide and Sirolimus (OCR) in 28 day cycles.~Cyclophosphamide and Sirolimus : The dose of cyclophosphamide will start at 200 mg (4 tablets) per day on day 1 and will be taken for 7 days every other week of a 28 day cycle.~Subjects will take 12 mg (12 tablets) of sirolimus on day 1 of treatment as a loading dose followed by 4 mg (4 tablets) daily continuously"
1029920|NCT00743509|O1|Outcome|Oral Cyclophosphamide and Sirolimus (OCR)|"Sarcoma patients were given oral Cyclophosphamide and Sirolimus (OCR) in 28 day cycles.~Cyclophosphamide and Sirolimus : The dose of cyclophosphamide will start at 200 mg (4 tablets) per day on day 1 and will be taken for 7 days every other week of a 28 day cycle.~Subjects will take 12 mg (12 tablets) of sirolimus on day 1 of treatment as a loading dose followed by 4 mg (4 tablets) daily continuously"
1029921|NCT00743509|E1|Reported Event|Oral Cyclophosphamide and Sirolimus (OCR)|"Sarcoma patients were given oral Cyclophosphamide and Sirolimus (OCR) in 28 day cycles.~Cyclophosphamide and Sirolimus : The dose of cyclophosphamide will start at 200 mg (4 tablets) per day on day 1 and will be taken for 7 days every other week of a 28 day cycle.~Subjects will take 12 mg (12 tablets) of sirolimus on day 1 of treatment as a loading dose followed by 4 mg (4 tablets) daily continuously"
1029922|NCT00743483|B1|Baseline|BSSL|Bucelipase alfa (INN): oral suspension, 170 mg BSSL, 3 times daily for 5-6 days
1029923|NCT00743483|P1|Participant Flow|rhBSSL|Oral suspension, 170 mg rhBSSL, 3 times daily for 5-6 days
1029924|NCT00743483|O1|Outcome|rhBSSL|oral suspension, 170 mg, 3 times daily for 5-6 days
1029925|NCT00743483|E1|Reported Event|BSSL|Oral suspension, 170 mg, 3 times daily for 5-6 days
1029926|NCT00743444|B1|Baseline|Entire Study Population|Includes groups randomized to received Drug first and Placebo first.
1029927|NCT00743444|P2|Participant Flow|Placebo First, Then AZD3355|65 mg drug or placebo capsules, oral, 3 single doses
1029928|NCT00743444|P1|Participant Flow|AZD3355 First, Then Placebo|65 mg drug or placebo capsules, oral, 3 single doses
1029929|NCT00743444|O1|Outcome|AZD3355|65 mg drug capsules, oral, 3 single doses
1029930|NCT00743444|O2|Outcome|Placebo|placebo capsules, oral, 3 single doses
1029931|NCT00743444|O1|Outcome|AZD3355|65 mg drug capsules, oral, 3 single doses
1029932|NCT00743444|O2|Outcome|Placebo|placebo capsules, oral, 3 single doses
1029933|NCT00743444|O1|Outcome|AZD3355|65 mg drug capsules, oral, 3 single doses
1029934|NCT00743444|E2|Reported Event|Placebo|placebo capsules, oral, 3 single doses
1029935|NCT00743444|E1|Reported Event|AZD3355|65 mg drug capsules, oral, 3 single doses
1029936|NCT00743431|B1|Baseline|Pegylated Lyposomal Doxorubicin|50 mg/m2 every 4 weeks for 6 cycles
1029937|NCT00743431|P1|Participant Flow|Pegylated Lyposomal Doxorubicin|50 mg/m2 every 4 weeks for 6 cycles
1029938|NCT00743431|O1|Outcome|Pegylated Lyposomal Doxorubicin|50 mg/m2 every 4 weeks for 6 cycles
1029939|NCT00743431|E1|Reported Event|Pegylated Lyposomal Doxorubicin|50 mg/m2 every 4 weeks for 6 cycles
1029940|NCT00743288|B1|Baseline|Melphalan and Panobinostat (LBH589)|"Schedule A: 10mg/daily of LBH589 per orem (PO) on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1.~Toxicity led to the following changes in dose and schedule Schedule B1: 10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule B2: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan POon days 1, 3 and 5 of week 1.~Schedule C: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1 and 2 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1 Schedule D1: 15 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule D2: 15 mg/daily LBH589 PO and 0.10 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule D3: 20 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1."
1029941|NCT00743288|P7|Participant Flow|Melphalan and Panobinostat Schedule D3|20 mg/daily of LBH589 PO and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of weeks 1 of a 28-day cycle
1029942|NCT00743288|P6|Participant Flow|Melphalan and Panobinostat Schedule D2|15 mg/daily of LBH589 PO and melphalan PO at 0.10 mg/kg on days 1, 3 and 5 of weeks 1 of a 28-day cycle
1029947|NCT00743288|P1|Participant Flow|Melphalan and Panobinostat Schedule A|10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1.
1029948|NCT00743288|O5|Outcome|Melphalan and Panobinostat All Patients|Data for all patients irrespective of dosage
1029949|NCT00743288|O4|Outcome|Melphalan and Panobinostat Schedule D|"Schedules D1, D2 and D3~D1:LBH589 15mg/daily and melphalan 0.05mg/kg on days 1, 3 and 5 of week 1 D2: LBH589 15mg and daily melphalan 0.10 mg/kg on days 1, 3 and 5 of week 1 D3: LBH589 20mg daily and melphalan 0.05mg/kg on days days 1, 3 and 5 of week 1"
1029950|NCT00743288|O3|Outcome|Melphalan and Panobinostat Schedule C|0.05 mg/kg melphalan on days 1, 3 and 5 of week 1 and 20 mg of LBH589 on days 1, 3, and 5 of weeks 1 and 2.
1029951|NCT00743288|O2|Outcome|Melphalan and Panobinostat Schedule B|"Schedules B1 and B2 B1: 10 mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 of a 28 day schedule and 0.04 mg/kg melphalan on days 1, 3 and 5 of week 1.~B2:20 mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 of a 28 day schedule and 0.04 mg/kg melphalan on days 1, 3 and 5 of week 1"
1029952|NCT00743288|O1|Outcome|Melphalan and Panobinostat Schedule A|10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1.
1029953|NCT00743288|O1|Outcome|Melphalan and Panobinostat Schedule D3|20mg daily LBH589 and 0.05mg/kg melphalan on days 1, 3 and 5 of week 1
1029954|NCT00743288|O1|Outcome|Melphalan and Panobinostat Schedule D3|20mg daily LBH589 and 0.05mg/kg melphalan on days 1, 3 and 5 of week 1
1029955|NCT00743288|O1|Outcome|Melphalan and Panobinostat|"Schedule A: 10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1.~Toxicity led to the following changes in dose and schedule Schedule B1: 10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule B2: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan POon days 1, 3 and 5 of week 1.~Schedule C: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1 and 2 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1 Schedule D1: 15 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule D2: 15 mg/daily LBH589 PO and 0.10 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule D3: 20 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1."
1029956|NCT00743288|O1|Outcome|Melphalan and Panobinostat Schedule B|"B1: 10mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 and 0.05mg/kg melphalan on days 1, 3 and 5 of week 1.~B2: 20mg/daily LBH589 on days 1, 3 and 5 of weeks 1-4 and 0.05mg/kg melphalan on days 1, 3 and 5 of week 1."
1029957|NCT00743288|E1|Reported Event|Melphalan and Panobinostat|"Schedule A: 10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1.~Toxicity led to the following changes in dose and schedule Schedule B1: 10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule B2: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan POon days 1, 3 and 5 of week 1.~Schedule C: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1 and 2 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1 Schedule D1: 15 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule D2: 15 mg/daily LBH589 PO and 0.10 mg/kg melphalan PO on days 1, 3 and 5 of week 1.~Schedule D3: 20 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1."
1029958|NCT00743275|B3|Baseline|Total|Total of all reporting groups
1029959|NCT00743275|B2|Baseline|Age 61 Years and Older|Participants received one dose of Fluzone® vaccine on Day 0.
1029960|NCT00743275|B1|Baseline|Age 18-60 Years|Participants received one dose of Fluzone® vaccine on Day 0.
1029961|NCT00743275|P2|Participant Flow|Age 61 Years and Older|Participants received one dose of Fluzone® vaccine on Day 0.
1029962|NCT00743275|P1|Participant Flow|Age 18-60 Years|Participants received one dose of Fluzone® vaccine on Day 0.
1029963|NCT00743275|O2|Outcome|Age 61 Years and Older|Participants received one dose of Fluzone® vaccine on Day 0.
1029964|NCT00743275|O1|Outcome|Age 18-60 Years|Participants received one dose of Fluzone® vaccine on Day 0.
1029965|NCT00743275|O2|Outcome|Age 61 Years and Older|Participants received one dose of Fluzone® vaccine on Day 0.
1029966|NCT00743275|O1|Outcome|Age 18-60 Years|Participants received one dose of Fluzone® vaccine on Day 0.
1029967|NCT00743275|O2|Outcome|Age 61 Years and Older|Participants received one dose of Fluzone® vaccine on Day 0.
1029968|NCT00743275|O1|Outcome|Age 18-60 Years|Participants received one dose of Fluzone® vaccine on Day 0.
1029969|NCT00743275|O2|Outcome|Age 61 Years and Older|Participants received one dose of Fluzone® vaccine on Day 0.
1029970|NCT00743275|O1|Outcome|Age 18-60 Years|Participants received one dose of Fluzone® vaccine on Day 0.
1029971|NCT00743275|E2|Reported Event|Age 61 Years and Older|Participants received one dose of Fluzone® vaccine on Day 0.
1029972|NCT00743275|E1|Reported Event|Age 18-60 Years|Participants received one dose of Fluzone® vaccine on Day 0.
1029973|NCT00743262|B1|Baseline|Provox Vega 22.5 French|A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
1029974|NCT00743262|P1|Participant Flow|Provox Vega 22.5 French|A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
1029975|NCT00743262|O1|Outcome|Provox Vega 22.5 French|A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
1029976|NCT00743262|O1|Outcome|Provox Vega 22.5 French|A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
1029977|NCT00743262|O1|Outcome|Provox Vega 22.5 French|A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
1029978|NCT00743262|E1|Reported Event|Provox Vega 22.5 French|A group of laryngectomized Provox ActiValve users tested the Provox Vega 22.5 French voice prosthesis for 3 weeks.
1029979|NCT00743249|B3|Baseline|Total|Total of all reporting groups
1030296|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
1029981|NCT00743249|B1|Baseline|Canalicular Stent, 10 mm|MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
1029982|NCT00743249|P2|Participant Flow|Canalicular Stent, 20 mm|MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
1029984|NCT00743249|O2|Outcome|Canalicular Stent, 20 mm|MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
1029985|NCT00743249|O1|Outcome|Canalicular Stent, 10 mm|MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
1029986|NCT00743249|O2|Outcome|Canalicular Stent, 20 mm|MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
1029987|NCT00743249|O1|Outcome|Canalicular Stent, 10 mm|MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
1029988|NCT00743249|E2|Reported Event|Canalicular Stent, 20 mm|MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
1029989|NCT00743249|E1|Reported Event|Canalicular Stent, 10 mm|MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
1029990|NCT00743197|B3|Baseline|Total|Total of all reporting groups
1029991|NCT00743197|B2|Baseline|Medical Treatment Group|TREATMENT GROUP—therapy in this group will be conventional treatment for CAD but targeting endothelial function, which will include aspirin, ACE-inhibitor and statin therapy, and therapeutic lifestyle changes.
1029992|NCT00743197|B1|Baseline|Usual Care Group|USUAL CARE GROUP—therapy in this group will be no dictated medical therapy, but usual care, as dictated by their referring physician.
1029993|NCT00743197|P2|Participant Flow|Medical Treatment Group|TREATMENT GROUP—therapy in this group will be conventional treatment for CAD but targeting endothelial function, which will include aspirin, ACE-inhibitor and statin therapy, and therapeutic lifestyle changes.
1029994|NCT00743197|P1|Participant Flow|Usual Care Group|USUAL CARE GROUP—therapy in this group will be no dictated medical therapy, but usual care, as dictated by their referring physician.
1029995|NCT00743197|O2|Outcome|Medical Treatment Group|
1029996|NCT00743197|O1|Outcome|Usual Care Group|
1029997|NCT00743197|E2|Reported Event|Medical Treatment Group|TREATMENT GROUP—therapy in this group will be conventional treatment for CAD but targeting endothelial function, which will include aspirin, ACE-inhibitor and statin therapy, and therapeutic lifestyle changes.
1029998|NCT00743197|E1|Reported Event|Usual Care Group|USUAL CARE GROUP—therapy in this group will be no dictated medical therapy, but usual care, as dictated by their referring physician.
1029999|NCT00743106|B3|Baseline|Total|Total of all reporting groups
1030000|NCT00743106|B2|Baseline|Fenoldopam|"Fenoldopam (0.1 ~g/kg/min)infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.~Fenoldopam: Fenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours"
1030001|NCT00743106|B1|Baseline|Placebo|"Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours~Placebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery"
1030002|NCT00743106|P2|Participant Flow|Fenoldopam|"Fenoldopam (0.1 ~g/kg/min)infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.~Fenoldopam: Fenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours"
1030003|NCT00743106|P1|Participant Flow|Placebo|"Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours~Placebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery"
1030004|NCT00743106|O2|Outcome|Fenoldopam|"Fenoldopam (0.1 ~g/kg/min)infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.~Fenoldopam: Fenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours"
1030005|NCT00743106|O1|Outcome|Placebo|"Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours~Placebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery"
1030006|NCT00743106|E2|Reported Event|Fenoldopam|"Fenoldopam (0.1 ~g/kg/min)infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.~Fenoldopam: Fenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours"
1030007|NCT00743106|E1|Reported Event|Placebo|"Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours~Placebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery"
1030008|NCT00743093|B3|Baseline|Total|Total of all reporting groups
1030009|NCT00743093|B2|Baseline|Placebo Arm|placebo
1030010|NCT00743093|B1|Baseline|Acetaminophen Arm|acetaminophen 500 mg
1030011|NCT00743093|P2|Participant Flow|Placebo Arm|"placebo~placebo : placebo caplets, 2 caplets per dose, 4 doses per day, 4 hours apart for 16 to 40 days"
1030012|NCT00743093|P1|Participant Flow|Acetaminophen Arm|"acetaminophen~acetaminophen : 500 mg caplets; 2 capsules (1 g)/dose; 4 doses (4 g)/day, 4 hours apart for 16 to 40 days."
1030013|NCT00743093|O2|Outcome|Placebo Arm|"placebo~placebo : placebo caplets, 2 caplets per dose, 4 doses per day, 4 hours apart for 16 to 40 days"
1030014|NCT00743093|O1|Outcome|Acetaminophen Arm|"acetaminophen~acetaminophen : 500 mg caplets; 2 capsules (1 g)/dose; 4 doses (4 g)/day, 4 hours apart for 16 to 40 days."
1030015|NCT00743093|O2|Outcome|Placebo Arm|"placebo~placebo : placebo caplets, 2 caplets per dose, 4 doses per day, 4 hours apart for 16 to 40 days"
1030016|NCT00743093|O1|Outcome|Acetaminophen Arm|"acetaminophen~acetaminophen : 500 mg caplets; 2 capsules (1 g)/dose; 4 doses (4 g)/day, 4 hours apart for 16 to 40 days."
1030017|NCT00743093|E2|Reported Event|Placebo Arm|"placebo~placebo : placebo caplets, 2 caplets per dose, 4 doses per day, 4 hours apart for 16 to 40 days"
1030297|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
1030018|NCT00743093|E1|Reported Event|Acetaminophen Arm|"acetaminophen~acetaminophen : 500 mg caplets; 2 capsules (1 g)/dose; 4 doses (4 g)/day, 4 hours apart for 16 to 40 days."
1030019|NCT00742924|B5|Baseline|Total|Total of all reporting groups
1030056|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group.|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030020|NCT00742924|B4|Baseline|Chemotherapy and 2.3 mg/m2 Zoledronic Acid After MTD|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
1030021|NCT00742924|B3|Baseline|Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
1030022|NCT00742924|B2|Baseline|Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
1030023|NCT00742924|B1|Baseline|Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery .~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
1030024|NCT00742924|P4|Participant Flow|Chemotherapy and 2.3 mg/m2 Zoledronic Acid After MTD|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
1030025|NCT00742924|P3|Participant Flow|Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
1030026|NCT00742924|P2|Participant Flow|Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
1030298|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
1034370|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
1030057|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030027|NCT00742924|P1|Participant Flow|Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery .~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
1030028|NCT00742924|O4|Outcome|Chemotherapy and 2.3 mg/m2 Zoledronic Acid After MTD|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
1030029|NCT00742924|O3|Outcome|Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
1030030|NCT00742924|O2|Outcome|Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
1030031|NCT00742924|O1|Outcome|Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery .~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
1030032|NCT00742924|E4|Reported Event|Chemotherapy and 2.3 mg/m2 Zoledronic Acid After MTD|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
1030033|NCT00742924|E3|Reported Event|Arm 3 - Chemotherapy and 3.5 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
1030055|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group.|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030301|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
1030034|NCT00742924|E2|Reported Event|Arm 2 - Chemotherapy and 2.3 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery.~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
1030035|NCT00742924|E1|Reported Event|Arm 1- Chemotherapy and 1.2 mg/m2 Zoledronic Acid|"(Weeks 1-11) Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; and G-CSF SC. (Week 12) Patients undergo therapeutic conventional surgery .~(Weeks 13-25): Patients receive etoposide IV; ifosfamide IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; G-CSF SC. (Week 26) Patients may undergo surgical procedure.~(Weeks 27-36): Patients receive dexrazoxane hydrochloride IV; doxorubicin hydrochloride IV; cisplatin IV; zoledronic acid IV; high-dose methotrexate IV; leucovorin calcium IV or orally; etoposide IV; ifosfamide IV; and filgrastim (G-CSF) SC.~See Detailed Description.~cisplatin: Given IV~dexrazoxane hydrochloride: Given IV~doxorubicin hydrochloride: Given IV~etoposide: Given IV~ifosfamide: Given IV~leucovorin calcium: Given IV or orally"
1030036|NCT00742885|B3|Baseline|Total|Total of all reporting groups
1030037|NCT00742885|B2|Baseline|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030038|NCT00742885|B1|Baseline|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030039|NCT00742885|P2|Participant Flow|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030040|NCT00742885|P1|Participant Flow|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030041|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030042|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030043|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030044|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030045|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm
1030046|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030047|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030048|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030049|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030050|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030051|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030052|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030053|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030054|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030302|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
1030058|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030059|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030060|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030061|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030062|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030063|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030064|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030065|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030066|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030067|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030068|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030069|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030070|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030071|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030072|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030073|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030074|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030075|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030076|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030077|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030078|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030079|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030080|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030299|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
1030081|NCT00742885|O2|Outcome|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030082|NCT00742885|O1|Outcome|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030083|NCT00742885|E2|Reported Event|Influenza A (H5N1) 41-64 Years Group|Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030084|NCT00742885|E1|Reported Event|Influenza A (H5N1) 20-40 Years Group|Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
1030085|NCT00742872|B3|Baseline|Total|Total of all reporting groups
1030086|NCT00742872|B2|Baseline|Placebo|"Placebo~Placebo : One tablet (identical in shape and form to the actual drug) taken orally three times per day (15 min before meals) for 8 weeks."
1030087|NCT00742872|B1|Baseline|Study|"Mosapride~Mosapride Citrate : One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks."
1030088|NCT00742872|P2|Participant Flow|Placebo|"Placebo~Placebo : One tablet (identical in shape and form to the actual drug) taken orally three times per day (15 min before meals) for 8 weeks."
1030089|NCT00742872|P1|Participant Flow|Study|"Mosapride~Mosapride Citrate : One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks."
1030090|NCT00742872|O2|Outcome|Placebo|"Placebo~Placebo : One tablet (identical in shape and form to the actual drug) taken orally three times per day (15 min before meals) for 8 weeks."
1030091|NCT00742872|O1|Outcome|Study|"Mosapride~Mosapride Citrate : One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks."
1030092|NCT00742872|E2|Reported Event|Placebo|"Placebo~Placebo : One tablet (identical in shape and form to the actual drug) taken orally three times per day (15 min before meals) for 8 weeks."
1030093|NCT00742872|E1|Reported Event|Study|"Mosapride~Mosapride Citrate : One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks."
1030094|NCT00742781|B1|Baseline|Vitamin D Supplementation|
1030095|NCT00742781|P1|Participant Flow|Vitamin D Supplementation|
1030096|NCT00742781|O2|Outcome|Vitamin D Supplemented|
1030097|NCT00742781|O1|Outcome|Baseline|
1030098|NCT00742781|O2|Outcome|Vitamin D Supplemented|
1030099|NCT00742781|O1|Outcome|Baseline|
1030100|NCT00742781|O2|Outcome|Vitamin D Supplemented|
1030101|NCT00742781|O1|Outcome|Baseline|
1030102|NCT00742781|E1|Reported Event|Vitamin D Supplemented|
1030103|NCT00742625|B1|Baseline|Bortezomib + Daunorubicin + Cytarabine|"Bortezomib:~Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)~Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11~Cytarabine:~Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5~Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)"
1030104|NCT00742625|P1|Participant Flow|Bortezomib + Daunorubicin + Cytarabine|"Bortezomib:~Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)~Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11~Cytarabine:~Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5~Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)"
1030105|NCT00742625|O1|Outcome|Bortezomib + Daunorubicin + Cytarabine|"Bortezomib:~Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)~Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11~Cytarabine:~Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5~Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)"
1030106|NCT00742625|O1|Outcome|Bortezomib + Daunorubicin + Cytarabine|"Bortezomib:~Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)~Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11~Cytarabine:~Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5~Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)"
1030107|NCT00742625|O3|Outcome|Bortezomib (1.3 mg/m^2) + Int-DAC|Bortezomib (1.3 mg/m^2) + Intermediate Dose Cytarabine (Int-DAC)
1030108|NCT00742625|O2|Outcome|Bortezomib (1.0 mg/m^2) + Int-DAC|Bortezomib (1.0 mg/m^2) + Intermediate Dose Cytarabine (Int-DAC)
1030109|NCT00742625|O1|Outcome|Bortezomib (0.7 mg/m^2) + Int-DAC|Bortezomib (0.7 mg/m^2) + Intermediate Dose Cytarabine (Int-DAC)
1030110|NCT00742625|O1|Outcome|Bortezomib + Daunorubicin + Cytarabine|"Bortezomib:~Induction: 1.3 mg/sq m IV infusion Days 1,4,8,11 (Days 1, 4 only if 2nd induction)~Consolidation: 0.7 OR 1 OR 1.3 mg/sq m IV infusion Days 1,4,8,11~Cytarabine:~Induction: 100 mg/sq m/day CIVI Days 1-7 (Days 1-5 only if 2nd induction) Consolidation: 2 g/sq m/day IV infusion Days 1-5~Daunorubicin Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)"
1030111|NCT00742625|E1|Reported Event|Bortezomib + Daunorubicin + Cytarabine|Induction: 60 mg/sq m IV infusion Days 1-3 (Days 1-2 if 2nd induction)
1030112|NCT00742508|B3|Baseline|Total|Total of all reporting groups
1030113|NCT00742508|B2|Baseline|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
1030300|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
1030197|NCT00742417|O1|Outcome|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
1030198|NCT00742417|O2|Outcome|Control (Sham Procedure)|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
1075905|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
1030114|NCT00742508|B1|Baseline|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
1030115|NCT00742508|P2|Participant Flow|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
1030116|NCT00742508|P1|Participant Flow|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
1030117|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
1030118|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
1030119|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
1030120|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
1030121|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
1030183|NCT00742417|O1|Outcome|Albutein 5%|"Patients allocated to this arm will undergo plasma exchange with Albutein 5%.~Albutein 5%: 18 Plasma Exchanges using~Albutein 5% or~Sham Procedure~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
1030184|NCT00742417|O2|Outcome|Control (Sham Procedure)|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
1030122|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
1030123|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
1030124|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
1030125|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
1030126|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
1030127|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
1030128|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
1030129|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
1030185|NCT00742417|O1|Outcome|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
1030186|NCT00742417|O2|Outcome|Control (Sham Procedure)|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
1030303|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
1030130|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
1030131|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
1030132|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
1030133|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
1030134|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
1030135|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
1030136|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
1030137|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
1030187|NCT00742417|O1|Outcome|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
1030188|NCT00742417|O2|Outcome|Control (Sham Procedure)|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
1034371|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
1030138|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
1030139|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
1030140|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
1030141|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
1030142|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
1030143|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
1030144|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
1030145|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
1030189|NCT00742417|O1|Outcome|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
1030190|NCT00742417|O2|Outcome|Control|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
1030577|NCT00741156|O5|Outcome|Cerebral Blood Flow Baseline|Cerebral blood flow at baseline
1030146|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
1030147|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
1030148|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
1030149|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
1030150|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
1030151|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
1030152|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
1030153|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
1030191|NCT00742417|O1|Outcome|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
1030192|NCT00742417|O2|Outcome|Control|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
1030626|NCT00741026|O1|Outcome|Placebo|
1030627|NCT00741026|O2|Outcome|Olanzapine|
1030154|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
1030155|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
1030156|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
1030157|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
1030158|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
1030159|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
1030160|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
1030161|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
1030193|NCT00742417|O1|Outcome|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
1030194|NCT00742417|O2|Outcome|Control|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
1030628|NCT00741026|O1|Outcome|Placebo|
1030629|NCT00741026|O2|Outcome|Olanzapine|
1030162|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
1030163|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
1030164|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
1030165|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
1030166|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
1030167|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
1030168|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
1030169|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
1030195|NCT00742417|O1|Outcome|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
1030196|NCT00742417|O2|Outcome|Control (Sham Procedure)|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
1030630|NCT00741026|O1|Outcome|Placebo|
1030170|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
1030171|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
1030172|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
1030173|NCT00742508|O2|Outcome|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
1030174|NCT00742508|O1|Outcome|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
1030175|NCT00742508|E2|Reported Event|SK&F-105517-D|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period.
1030176|NCT00742508|E1|Reported Event|CRV-IR|In the 8-week Primary Evaluation Period (including the 2-week Run-in Period [from Week 0 as Baseline]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose.
1030177|NCT00742417|B3|Baseline|Total|Total of all reporting groups
1030178|NCT00742417|B2|Baseline|Control|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
1030179|NCT00742417|B1|Baseline|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
1030180|NCT00742417|P2|Participant Flow|Control (Sham Procedure)|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
1030181|NCT00742417|P1|Participant Flow|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
1030182|NCT00742417|O2|Outcome|Control|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
1030295|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
1030199|NCT00742417|O1|Outcome|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
1030200|NCT00742417|E2|Reported Event|Control (Sham Procedure)|Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
1030201|NCT00742417|E1|Reported Event|Albutein 5%|"18 Plasma Exchanges using Albutein 5%:~three weeks of intensive treatment with two plasma exchanges per week~six weeks of maintenance treatment with one weekly plasma exchange~three months of maintenance treatment with one plasma exchange every two weeks"
1030202|NCT00742391|B3|Baseline|Total|Total of all reporting groups
1030203|NCT00742391|B2|Baseline|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
1030204|NCT00742391|B1|Baseline|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
1030205|NCT00742391|P2|Participant Flow|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
1030206|NCT00742391|P1|Participant Flow|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
1030207|NCT00742391|O2|Outcome|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
1030208|NCT00742391|O1|Outcome|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
1030209|NCT00742391|O2|Outcome|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
1030210|NCT00742391|O1|Outcome|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
1030211|NCT00742391|E2|Reported Event|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
1030212|NCT00742391|E1|Reported Event|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
1030213|NCT00742326|B3|Baseline|Total|Total of all reporting groups
1030214|NCT00742326|B2|Baseline|Placebo|Placebo once daily for 48 weeks
1030215|NCT00742326|B1|Baseline|Pioglitazone|"pioglitazone 45 mg daily for 48 weeks~Pioglitazone"
1030216|NCT00742326|P2|Participant Flow|Placebo|Placebo once daily for 48 weeks
1030217|NCT00742326|P1|Participant Flow|Pioglitazone|"pioglitazone 45 mg daily for 48 weeks~Pioglitazone"
1030218|NCT00742326|O2|Outcome|Placebo|Placebo once daily for 48 weeks
1030219|NCT00742326|O1|Outcome|Pioglitazone|"pioglitazone 45 mg daily for 48 weeks~Pioglitazone"
1030220|NCT00742326|O2|Outcome|Placebo|Placebo once daily for 48 weeks
1030221|NCT00742326|O1|Outcome|Pioglitazone|"pioglitazone 45 mg daily for 48 weeks~Pioglitazone"
1030222|NCT00742326|E2|Reported Event|Placebo|Placebo once daily for 48 weeks
1030223|NCT00742326|E1|Reported Event|Pioglitazone|"pioglitazone 45 mg daily for 48 weeks~Pioglitazone"
1030224|NCT00742313|B3|Baseline|Total|Total of all reporting groups
1030225|NCT00742313|B2|Baseline|Control|Arm B does not have FloSeal Matrix applied to EVH wound bed.
1030226|NCT00742313|B1|Baseline|FloSeal|Arm A has FloSeal Matrix applied to EVH wound bed.
1030227|NCT00742313|P2|Participant Flow|Non-FloSeal Matrix|FloSeal Matrix was not added to the wound bed
1030228|NCT00742313|P1|Participant Flow|FloSeal Matrix|FloSeal Matrix applied to EVH wound bed.
1030229|NCT00742313|O2|Outcome|Control|Arm B does not have FloSeal Matrix applied to EVH wound bed.
1030230|NCT00742313|O1|Outcome|FloSeal Matrix|Arm A has FloSeal Matrix applied to EVH wound bed.
1030231|NCT00742313|E2|Reported Event|Arm B|Arm B does not have FloSeal Matrix applied to EVH wound bed.
1030232|NCT00742313|E1|Reported Event|Arm A|Arm A has FloSeal Matrix applied to EVH wound bed.
1030233|NCT00742274|B3|Baseline|Total|Total of all reporting groups
1030234|NCT00742274|B2|Baseline|BEST MEDICAL THERAPY (BMT) Alone|
1030235|NCT00742274|B1|Baseline|TAG Device + Best Medical Therapy (BMT)|
1030236|NCT00742274|P2|Participant Flow|Best Medical Therapy (BMT) Alone|BMT alone
1030237|NCT00742274|P1|Participant Flow|TAG Device + Best Medical Therapy (BMT)|TAG+BMT
1030238|NCT00742274|O2|Outcome|BEST MEDICAL THERAPY (BMT) Alone|
1030239|NCT00742274|O1|Outcome|TAG Device + Best Medical Therapy (BMT)|
1030240|NCT00742274|E2|Reported Event|BEST MEDICAL THERAPY (BMT) Alone|
1030241|NCT00742274|E1|Reported Event|TAG Device + Best Medical Therapy (BMT)|
1030242|NCT00742235|B3|Baseline|Total|Total of all reporting groups
1030243|NCT00742235|B2|Baseline|Vitamin D Insufficient|Subjects found to have an initial 25-OH vitamin D level < 32 ng/mL were treated with ergocalciferol 50,000 IU every other day x 5 doses (250,000 IU total) and returned for repeat laboratory studies.
1030244|NCT00742235|B1|Baseline|Vitamin D Sufficient|Subjects with baseline 25-OH vitamin D levels ≥ 32 ng/ml were not treated with ergocalciferol.
1030245|NCT00742235|P2|Participant Flow|Vitamin D Insufficient|Subjects found to have an initial 25-OH vitamin D level < 32 ng/mL who were offered ergocalciferol 50,000 IU every other day x 5 doses (250,000 IU total)
1030246|NCT00742235|P1|Participant Flow|Vitamin D Sufficient|Subjects not treated with ergocalciferol and who had 25-OH vitamin D > 32 ng/ml.
1030247|NCT00742235|O2|Outcome|Vitamin D Insufficient|Subjects found to have an initial 25-OH vitamin D level < 32 ng/mL were treated with ergocalciferol 50,000 IU every other day x 5 doses (250,000 IU total) and returned for repeat laboratory studies.
1030248|NCT00742235|O1|Outcome|Vitamin D Sufficient|Subjects with baseline 25-OH vitamin D levels ≥ 32 ng/ml were not treated with ergocalciferol.
1030249|NCT00742235|O2|Outcome|Vitamin D Insufficient|Subjects found to have an initial 25-OH vitamin D level < 32 ng/mL were treated with ergocalciferol 50,000 IU every other day x 5 doses (250,000 IU total) and returned for repeat laboratory studies.
1030250|NCT00742235|O1|Outcome|Vitamin D Sufficient|Subjects with baseline 25-OH vitamin D levels ≥ 32 ng/ml were not treated with ergocalciferol.
1030251|NCT00742235|E2|Reported Event|Vitamin D Insufficient|Subjects found to have an initial 25-OH vitamin D level < 32 ng/mL were treated with ergocalciferol 50,000 IU every other day x 5 doses (250,000 IU total) and returned for repeat laboratory studies.
1030252|NCT00742235|E1|Reported Event|Vitamin D Sufficient|Subjects with baseline 25-OH vitamin D levels ≥ 32 ng/ml were not treated with ergocalciferol.
1030253|NCT00742209|B6|Baseline|Total|Total of all reporting groups
1030254|NCT00742209|B5|Baseline|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day.
1030255|NCT00742209|B4|Baseline|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day.
1030256|NCT00742209|B3|Baseline|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day.
1030257|NCT00742209|B2|Baseline|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day.
1030258|NCT00742209|B1|Baseline|Placebo|Oral GEn (XP13512) placebo on Weeks 1-17
1030259|NCT00742209|P5|Participant Flow|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day.
1030260|NCT00742209|P4|Participant Flow|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
1030261|NCT00742209|P3|Participant Flow|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
1030262|NCT00742209|P2|Participant Flow|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day.
1030263|NCT00742209|P1|Participant Flow|Placebo|Oral GEn (XP13512) placebo
1030264|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
1030265|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
1030266|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
1030267|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
1030268|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
1030269|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
1030270|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
1030271|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
1030272|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
1030273|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
1030274|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
1030275|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
1030276|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
1030277|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
1030278|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
1030279|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
1030280|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
1030281|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
1030282|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
1030283|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
1030284|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
1030285|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
1030286|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
1030287|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
1030288|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
1030289|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
1030290|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
1030291|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
1030292|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
1030293|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
1030294|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
1030631|NCT00741026|O2|Outcome|Olanzapine|
1030632|NCT00741026|O1|Outcome|Placebo|
1030304|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
1030305|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
1030486|NCT00741598|O1|Outcome|Galantamine-ER|16-week treatment with flexible doses (8-24mg/day)
1030306|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
1030307|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
1030308|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
1030309|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
1030310|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
1030311|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
1030312|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
1030313|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
1030314|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
1030315|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
1030316|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
1030317|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
1030318|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
1030319|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
1030320|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
1030321|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
1030322|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
1030323|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
1030324|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
1030325|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
1030326|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
1030327|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
1030328|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
1030329|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
1030330|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
1030331|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
1030332|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
1030333|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
1030334|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
1030335|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
1030336|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
1030337|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
1030338|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
1030339|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
1030340|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
1030341|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
1030342|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
1030343|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
1030344|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
1030345|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
1030346|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
1030347|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
1030348|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
1030633|NCT00741026|E2|Reported Event|Olanzapine|
1030349|NCT00742209|O5|Outcome|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
1030350|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
1030351|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
1030352|NCT00742209|O2|Outcome|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
1030353|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
1030354|NCT00742209|O4|Outcome|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
1030355|NCT00742209|O3|Outcome|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
1030356|NCT00742209|O2|Outcome|Average of GEn 1800/2400 mg|Average of GEn 1800 mg group and GEn 2400 mg group
1030357|NCT00742209|O1|Outcome|Placebo|Oral GEn (XP13512) placebo
1030358|NCT00742209|E5|Reported Event|GEn 3000 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4: 2400 mg/day. Weeks 5-17: 3000 mg/day
1030359|NCT00742209|E4|Reported Event|GEn 2400 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Week 3: 1800 mg/day. Weeks 4-17: 2400 mg/day
1030360|NCT00742209|E3|Reported Event|GEn 1800 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Week 2: 1200 mg/day. Weeks 3-17: 1800 mg/day
1030361|NCT00742209|E2|Reported Event|GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262). Week 1: 600 mg/day. Weeks 2-17: 1200 mg/day
1030362|NCT00742209|E1|Reported Event|Placebo|Oral GEn (XP13512) placebo
1030363|NCT00742183|B3|Baseline|Total|Total of all reporting groups
1030364|NCT00742183|B2|Baseline|Silvadene|
1030365|NCT00742183|B1|Baseline|Mepilex Ag|
1030366|NCT00742183|P2|Participant Flow|Silvadene|Silver sulfadiazine 1% cream treatment period will be a maximum of three weeks. Dressing changes of Silvadene® will be performed at least once per day.
1030367|NCT00742183|P1|Participant Flow|Mepilex Ag|"Treatment period will be a maximum of three weeks with Silvadene® or Mepilex® Ag.~Dressing changes of Mepilex® Ag will be performed every 5-7 day, depending on the status of the burn"
1030368|NCT00742183|O2|Outcome|Silvadene|
1030369|NCT00742183|O1|Outcome|Mepilex Ag|
1030370|NCT00742183|E2|Reported Event|Silvadene|
1030371|NCT00742183|E1|Reported Event|Mepilex Ag|
1030372|NCT00742170|B3|Baseline|Total|Total of all reporting groups
1030373|NCT00742170|B2|Baseline|Sham Stimulation|"In the sham electroacupuncture condition, the current is set at 1 mA, the lowest intensity possible before the HANS device shuts off; this is undetectable stimulation.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
1030374|NCT00742170|B1|Baseline|Active Stimulation|"In the active electroacupuncture condition, the current is set at 2 times threshold (approximately 6-10 mA), which typically produces muscle twitching.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
1030375|NCT00742170|P2|Participant Flow|Sham Electroacupuncture Condition|"In the sham electroacupuncture condition, the current is set at 1 mA, the lowest intensity possible before the HANS device shuts off; this is undetectable stimulation.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
1030376|NCT00742170|P1|Participant Flow|Active Electroacupuncture Condition|"Active electroacupuncture condition~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
1030377|NCT00742170|O2|Outcome|Sham Stimulation|"In the sham electroacupuncture condition, the current is set at 1 mA, the lowest intensity possible before the HANS device shuts off; this is undetectable stimulation.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
1030401|NCT00741988|O2|Outcome|Ixabepilone/Carboplatin/Bevacizumab|ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
1030946|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
1030402|NCT00741988|O1|Outcome|Ixabepilone/Carboplatin|ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
1030403|NCT00741988|O2|Outcome|Ixabepilone/Carboplatin/Bevacizumab|ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
1030378|NCT00742170|O1|Outcome|Active Stimulation|"In the active electroacupuncture condition, the current is set at 2 times threshold (approximately 6-10 mA), which typically produces muscle twitching.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
1030379|NCT00742170|O2|Outcome|Sham Stimulation|"In the sham electroacupuncture condition, the current is set at 1 mA, the lowest intensity possible before the HANS device shuts off; this is undetectable stimulation.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
1030380|NCT00742170|O1|Outcome|Active Stimulation|"In the active electroacupuncture condition, the current is set at 2 times threshold (approximately 6-10 mA), which typically produces muscle twitching.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
1030381|NCT00742170|E2|Reported Event|Sham Stimulation|"In the sham electroacupuncture condition, the current is set at 1 mA, the lowest intensity possible before the HANS device shuts off; this is undetectable stimulation.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
1030382|NCT00742170|E1|Reported Event|Active Stimulation|"In the active electroacupuncture condition, the current is set at 2 times threshold (approximately 6-10 mA), which typically produces muscle twitching.~Electroacupuncture: Participants are randomly assigned to receive either active or sham electroacupuncture using the Han's Acupoint Nerve Stimulator (HANS) device. The HANS method uses a non-invasive device that emits a constant electric current transcutaneously via skin electrodes to stimulate relevant acupoints: Heku (LI4) / Laogong (P8) on one hand and Neiguan (P6) / Waiguan (TE 5) on the opposite arm. Stimulation is delivered in the dense-and-disperse mode, alternating between 2 and 100 Hz at 3-second intervals. Participants receive thrice daily treatments for 4 days during inpatient opioid detoxification."
1030383|NCT00742079|B3|Baseline|Total|Total of all reporting groups
1030384|NCT00742079|B2|Baseline|2 Placebo, Then D-cycloserine|Participants received placebo 1 hour before a CBT session on Week 1, and then received 50 mg D-cycloserine 1 hour before a CBT session on Week 2.
1030385|NCT00742079|B1|Baseline|1 D-cycloserine, Then Placebo|Participants received 50 mg D-cycloserine 1 hour before a cognitive behavioral therapy (CBT) session on Week 1, and then received placebo 1 hour before a CBT session on Week 2.
1030386|NCT00742079|P2|Participant Flow|2 Placebo First, Then D-cycloserine|Participants received placebo 1 hour before a CBT session on Week 1, and then received 50 mg D-cycloserine 1 hour before a CBT session on Week 2.
1030387|NCT00742079|P1|Participant Flow|1 D-cycloserine First, Then Placebo|Participants received 50 mg D-cycloserine 1 hour before a cognitive behavioral therapy (CBT) session on Week 1, and then received placebo 1 hour before a CBT session on Week 2.
1030388|NCT00742079|O2|Outcome|Placebo, D-cycloserine|Participants will receive 50 mg of placebo 1 hour before a CBT session on Week 1, and they will receive 50 mg of D-cycloserine 1 hour before a CBT session on Week 2.
1030389|NCT00742079|O1|Outcome|D-cycloserine, Placebo|Participants will receive 50 mg of D-cycloserine 1 hour before a cognitive behavioral therapy (CBT) session on Week 1, and they will receive 50 mg of placebo 1 hour before a CBT session on Week 2.
1030390|NCT00742079|E2|Reported Event|2 Placebo, Then D-cycloserine|Participants received placebo 1 hour before a CBT session on Week 1, and then received 50 mg D-cycloserine 1 hour before a CBT session on Week 2.
1030391|NCT00742079|E1|Reported Event|1 D-cycloserine, Then Placebo|Participants received 50 mg D-cycloserine 1 hour before a cognitive behavioral therapy (CBT) session on Week 1, and then received placebo 1 hour before a CBT session on Week 2.
1030392|NCT00742053|B1|Baseline|PICC Insertion|All patients, aged 18 to 80 years, who required PICC insertion for their standard care will be studied.
1030393|NCT00742053|P1|Participant Flow|PICC Insertion|All patients, aged 18 to 80 years, who required Peripherally inserted central catheter (PICC) insertion for their standard care will be studied.
1030394|NCT00742053|O1|Outcome|PICC Placement|Patients who require PICC placement
1030395|NCT00742053|E1|Reported Event|PICC Insertion|All patients, aged 18 to 80 years, who required PICC insertion for their standard care will be studied.
1030396|NCT00741988|B3|Baseline|Total|Total of all reporting groups
1030397|NCT00741988|B2|Baseline|Ixabepilone/Carboplatin/Bevacizumab|ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
1030398|NCT00741988|B1|Baseline|Ixabepilone/Carboplatin|ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
1030399|NCT00741988|P2|Participant Flow|Ixabepilone/Carboplatin/Bevacizumab|ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
1030400|NCT00741988|P1|Participant Flow|Ixabepilone/Carboplatin|ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
1030404|NCT00741988|O1|Outcome|Ixabepilone/Carboplatin|ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
1030405|NCT00741988|O2|Outcome|Ixabepilone/Carboplatin/Bevacizumab|ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
1030406|NCT00741988|O1|Outcome|Ixabepilone/Carboplatin|ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
1030407|NCT00741988|E2|Reported Event|Ixabepilone/Carboplatin/Bevacizumab|ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
1030408|NCT00741988|E1|Reported Event|Ixabepilone/Carboplatin|ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
1030409|NCT00741936|B3|Baseline|Total|Total of all reporting groups
1030410|NCT00741936|B2|Baseline|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1030411|NCT00741936|B1|Baseline|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1030412|NCT00741936|P2|Participant Flow|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1030413|NCT00741936|P1|Participant Flow|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1030414|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1030415|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1030416|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1030417|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1030418|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1030419|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1030420|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1030421|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1030422|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1030423|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1030424|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1030425|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1030426|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1030427|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1030428|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1030429|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1030430|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1030431|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1030432|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1030433|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1030434|NCT00741936|O2|Outcome|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1030435|NCT00741936|O1|Outcome|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1030436|NCT00741936|E2|Reported Event|Placebo|Placebo granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1032201|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
1030437|NCT00741936|E1|Reported Event|MaZiRenWan (MZRW)|MZRW granule, 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1030438|NCT00741858|B3|Baseline|Total|Total of all reporting groups
1030439|NCT00741858|B2|Baseline|DuraGuard (Suturable)|"Duraguard - the Duraguard patch is applied over the dural defect during Chiari decompression surgery and sutured to the dural edge. This represents suturable technique that theoretically provides better (water-tight) dural closure.~Duraplasty with Duraguard: Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)"
1030440|NCT00741858|B1|Baseline|DuraGen (Sutureless)|"Duragen - the Duragen patch is applied over the dural defect during Chiari decompression surgery. The Duragen represents sutureless technique of posterior fossa duraplasty. Rest of the treatment is as usual.~Duraplasty with Duragen: Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)"
1030441|NCT00741858|P2|Participant Flow|DuraGuard (Suturable)|"Duraguard - the Duraguard patch is applied over the dural defect during Chiari decompression surgery and sutured to the dural edge. This represents suturable technique that theoretically provides better (water-tight) dural closure.~Duraplasty with Duraguard: Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)"
1030442|NCT00741858|P1|Participant Flow|DuraGen (Sutureless)|"Duragen - the Duragen patch is applied over the dural defect during Chiari decompression surgery. The Duragen represents sutureless technique of posterior fossa duraplasty. Rest of the treatment is as usual.~Duraplasty with Duragen: Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)"
1030443|NCT00741858|O2|Outcome|DuraGuard (Suturable)|"Duraguard - the Duraguard patch is applied over the dural defect during Chiari decompression surgery and sutured to the dural edge. This represents suturable technique that theoretically provides better (water-tight) dural closure.~Duraplasty with Duraguard: Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)"
1030444|NCT00741858|O1|Outcome|DuraGen (Sutureless)|"Duragen - the Duragen patch is applied over the dural defect during Chiari decompression surgery. The Duragen represents sutureless technique of posterior fossa duraplasty. Rest of the treatment is as usual.~Duraplasty with Duragen: Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)"
1030445|NCT00741858|E2|Reported Event|DuraGuard (Suturable)|"Duraguard - the Duraguard patch is applied over the dural defect during Chiari decompression surgery and sutured to the dural edge. This represents suturable technique that theoretically provides better (water-tight) dural closure.~Duraplasty with Duraguard: Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)"
1030446|NCT00741858|E1|Reported Event|DuraGen (Sutureless)|"Duragen - the Duragen patch is applied over the dural defect during Chiari decompression surgery. The Duragen represents sutureless technique of posterior fossa duraplasty. Rest of the treatment is as usual.~Duraplasty with Duragen: Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)"
1030447|NCT00741819|B1|Baseline|Inhaled Treprostinil|Inhaled treprostinil was titrated up to 12 breaths four times daily.
1030448|NCT00741819|P1|Participant Flow|Inhaled Treprostinil|Inhaled treprostinil was given four times daily at doses titrated up to 12 breaths.
1030449|NCT00741819|O1|Outcome|Inhaled Treprostinil|up to 12 breaths four times daily.
1030450|NCT00741819|O1|Outcome|Inhaled Treprostinil|up to 12 breaths four times daily.
1030451|NCT00741819|O1|Outcome|Inhaled Treprostinil|up to 12 breaths four times daily.
1030452|NCT00741819|O1|Outcome|Inhaled Treprostinil|up to 12 breaths four times daily.
1030453|NCT00741819|O1|Outcome|Inhaled Treprostinil|up to 12 breaths four times daily.
1030454|NCT00741819|O1|Outcome|Inhaled Treprostinil|up to 12 breaths four times daily.
1030455|NCT00741819|O1|Outcome|Inhaled Treprostinil|Up to 12 breaths four times daily.
1030456|NCT00741819|O1|Outcome|Inhaled Treprostinil|up to 12 breaths four times daily
1030457|NCT00741819|E1|Reported Event|Inhaled Treprostinil|Inhaled treprostinil was titrated up to 12 breaths four times daily.
1030458|NCT00741611|B4|Baseline|Total|Total of all reporting groups
1030459|NCT00741611|B3|Baseline|Roll-ins|Investigator's first patients treated with mesh prior to the start of the study randomization.
1030460|NCT00741611|B2|Baseline|Drug|Treatment with anti-arrhythmic drugs
1030461|NCT00741611|B1|Baseline|Mesh|Ablation with HD Mesh Ablation System
1030462|NCT00741611|P3|Participant Flow|Roll-ins|Investigator's first patients treated with the experimental mesh ablation system prior to the start of the study randomization.
1030463|NCT00741611|P2|Participant Flow|Drug|Treatment with anti-arrhythmic drugs: treatment was selected by the Investigator and administered in accordance with the approved drug labeling using labeled doses for the atrial fibrillation indication. Per protocol, medications were limited to sotalol, flecainide, propafenone, dofetilide, and amiodarone and did not include rate control medications or calcium chanel blockers.
1030464|NCT00741611|P1|Participant Flow|Mesh|Ablation with HD Mesh Ablation System; energy delivered to the heart tissue intended to disrupt the abnormal electrical pathways which cause atrial fibrillation to occur.
1030465|NCT00741611|O2|Outcome|Roll-ins|Investigator's first patients treated with mesh prior to the start of the study randomization.
1030466|NCT00741611|O1|Outcome|Mesh|Ablation with HD Mesh Ablation System
1030467|NCT00741611|O2|Outcome|Roll-ins|Investigator's first patients treated with mesh prior to the start of the study randomization.
1030468|NCT00741611|O1|Outcome|Mesh|Ablation with HD Mesh Ablation System
1030469|NCT00741611|O3|Outcome|Roll-ins|Investigator's first patients treated with mesh prior to the start of the study randomization.
1030470|NCT00741611|O2|Outcome|Drug|Treatment with anti-arrhythmic drugs
1030471|NCT00741611|O1|Outcome|Mesh|Ablation with HD Mesh Ablation System
1030472|NCT00741611|O3|Outcome|Roll-ins|Investigator's first patients treated with mesh prior to the start of the study randomization.
1030473|NCT00741611|O2|Outcome|Drug|Treatment with anti-arrhythmic drugs
1030474|NCT00741611|O1|Outcome|Mesh|Ablation with HD Mesh Ablation System
1030475|NCT00741611|O2|Outcome|Roll-ins|Investigator's first patients treated with mesh prior to the start of the study randomization.
1030476|NCT00741611|O1|Outcome|Mesh|Ablation with HD Mesh Ablation System
1034372|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
1030477|NCT00741611|E3|Reported Event|Roll-ins|Investigator's first patients treated with mesh prior to the start of the study randomization.
1030478|NCT00741611|E2|Reported Event|Drug|Treatment with anti-arrhythmic drugs
1030487|NCT00741598|O2|Outcome|Placebo|placebo equivalent
1030488|NCT00741598|O1|Outcome|Galantamine-ER|16-week treatment with flexible doses (8-24mg/day)
1030489|NCT00741598|O2|Outcome|Placebo|placebo equivalent
1030490|NCT00741598|O1|Outcome|Galantamine-ER|16-week treatment with flexible doses (8-24mg/day)
1030491|NCT00741598|O2|Outcome|Placebo|placebo equivalent
1030492|NCT00741598|O1|Outcome|Galantamine-ER|16-week treatment with flexible doses (8-24mg/day)
1030493|NCT00741598|O2|Outcome|Placebo|16-week treatment with flexible doses of placebo equivalent
1030494|NCT00741598|O1|Outcome|Galantamine-ER|16-week treatment with flexible doses (8-24mg/day)
1030495|NCT00741598|E2|Reported Event|Placebo|placebo equivalent
1030496|NCT00741598|E1|Reported Event|Galantamine-ER|16-week treatment with flexible doses (8-24mg/day)
1030497|NCT00741468|B1|Baseline|All Subjects|"Proellex 50 mg~Proellex: 2, 25 mg Proellex capsules administered daily"
1030498|NCT00741468|P1|Participant Flow|All Participants|CYP1A2, Day 8 relative to Day 1 AUC (caffeine probe) CYP2C19, Day 8 relative to Day 1 AUC (omeprazole probe) CYP 2C9, Day 8 relative to Day 1 AUC (tolbutamide probe) CYP2D6, Day 8 relative to Day 1 AUC (dextromethorphan probe) CYP3A4, Day 8 relative to Day 1 AUC (midazolam probe)
1030499|NCT00741468|O5|Outcome|CYP3A4|Day 8 relative to Day 1 AUC (midazolam probe)
1030500|NCT00741468|O4|Outcome|CYP2D6|Day 8 relative to Day 1 AUC (dextromethorphan probe)
1030501|NCT00741468|O3|Outcome|CYP2C19|Day 8 relative to Day 1 AUC (omeprazole probe)
1030502|NCT00741468|O2|Outcome|CYP2C9|Day 8 relative to Day 1 AUC (tolbutamide probe)
1030503|NCT00741468|O1|Outcome|CYP1A2|Day 8 relative to Day 1 AUC (caffeine probe)
1030504|NCT00741468|E1|Reported Event|All Subjects|"Proellex 50 mg~Proellex: 2, 25 mg Proellex capsules administered daily"
1030505|NCT00741390|B1|Baseline|Entire Study Population|
1030506|NCT00741390|P4|Participant Flow|Arm D|Visit1 (V1): BD/33G,OTM/33G,OTM/28G; V2: OTM/33G, OTM/28G The arm assignment determined which 3 of the 5 combinations of lancets and lancing devices the subjects would evaluate in Visit 1 (for volume adequacy) and of these 3, which 2 they would evaluate in Visit 2 (pain during lancing). The lancet/lancing device combinations assigned to Arm D are: Device 1: BD/33G (BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 2: OTM/33G (OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 3: OTM/28G (OneTouch® Mini Lancet device / OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips). For Visit 2 only the OTM/33G and OTM/28G were used.
1030507|NCT00741390|P3|Participant Flow|Arm C|Visit 1 (V1): BD/33G, OTM/33G,ACC/28G Visit 2 (V2): BD/33G, ACC/28G The arm assignment determined which 3 of the 5 combinations of lancets and lancing devices the subjects would evaluate in Visit 1 (for volume adequacy) and of these 3, which 2 they would evaluate in Visit 2 (pain during lancing). The lancet/lancing device combinations assigned to Arm C are: Device 1: BD/33G (BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 2: OTM/33G (OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 3: ACC/28G (Accu-Chek® Softclix Lancet device/Accu-Chek® Softclix 28G Lancet (BGM measured with Accu-Chek® Advantage BGM and Accu-Chek® Comfort Curve test strip). For Visit 2 only the BD/33G and ACC/28G were used.
1030508|NCT00741390|P2|Participant Flow|Arm B|Visit 1 (V1):BD/33G,OTM/33G,OTU/28G; Visit 2 (V2):BD/33G, OTU/28G The arm assignment determined which 3 of the 5 combinations of lancets and lancing devices the subjects would evaluate in Visit 1 (for volume adequacy) and of these 3, which 2 they would evaluate in Visit 2 (pain during lancing).The lancet/lancing device combinations assigned to Arm B are: Device 1: BD/33G (BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 2: OTM/33G (OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 3: OTU/28G (OneTouch® UltraSoft® Lancet device/OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips). For Visit 2 only the BD/33G and OTU/28G were used.
1030509|NCT00741390|P1|Participant Flow|Arm A|Visit1 (V1) Device: BD/33G,OTM/33G,OTM/28G; Visit2 (V2) Device: BD/33G,OTM/28G. The arm assignment determined which 3 of the 5 combinations of lancets and lancing devices the subjects would evaluate in Visit 1 (for volume adequacy) and of these 3, which 2 they would evaluate in Visit 2 (pain during lancing). The lancet/lancing device combinations assigned to Arm A are: Device 1: BD/33G (BD Lancet device/BD 33G lancets (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 2: OTM/33G (OneTouch® Mini Lancet device / BD 33G lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips) Device 3: OTM/28G (OneTouch® Mini Lancet device / OneTouch® UltraSoft® 28G Lancet (BGM measured with the OneTouch® UltraMini™ (BGM) and OneTouch® Ultra® test strips. For Visit 2 only the BD/33G and OTM/28G were used.
1030510|NCT00741390|O4|Outcome|OTM/28G - OTM/33G|OneTouch MiniDevice / OneTouch 28g Lancet - OneTouch MiniDevice /BD 33 Gauge Lancet
1030511|NCT00741390|O3|Outcome|ACC/28G - BD/33G|Accu-Chek Softclix Device / Accu-Chek Softclix 28G Lancet - BD Lancet Device / BD 33 gauge Lancet
1030512|NCT00741390|O2|Outcome|OTU/28G - BD/33G|OneTouch UltraSoft Device / OneTouch UltraSoft 28G Lancet - BD Lancet Device / BD 33 gauge Lancet
1030513|NCT00741390|O1|Outcome|OTM/28G - BD/33G|OneTouch Mini Device / OneTouch UltraSoft 28G Lancet - BD Lancet Device / BD 33 gauge Lancet
1032202|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
1030514|NCT00741390|O1|Outcome|OTM/28G - OTM/33G|OneTouch Mini Device/OneTouch UltraSoft 28G Lancet as compared to OneTouch Mini Device / BD 33G Lancet
1030515|NCT00741390|O3|Outcome|ACC/28G - BD/33G|Accu-Chek Softclix Device/Accu-Chek Softclix 28G Lancet as compared to BD Lancet Device / BD 33G Lancet
1030516|NCT00741390|O2|Outcome|OTU/28G - BD/33G|OneTouch UltraSoft Device/OneTouch UltraSoft 28G Lancet as compared to BD Lancet Device / BD 33G Lancet
1030517|NCT00741390|O1|Outcome|OTM/28G - BD/33G|OneTouch Mini Device/OneTouch UltraSoft 28G Lancet as compared to BD Lancet Device / BD 33G Lancet
1030518|NCT00741390|O5|Outcome|ACC/28G|"Accu-Chek Softclix Device / Accu-Chek Softclix 28G Lancet~See description for BD/33G."
1030519|NCT00741390|O4|Outcome|OTU/28G|"OneTouch UltraSoft Device / OneTouch UltraSoft 28G Lancet~See description for BD/33G."
1030520|NCT00741390|O3|Outcome|OTM/28G|"OneTouch Mini Device / OneTouch UltraSoft 28G Lancet~See description for BD/33G."
1030521|NCT00741390|O2|Outcome|OTM/33G|"OneTouch Mini Device / BD 33 Gauge Lancet~See description for BD/33G."
1030522|NCT00741390|O1|Outcome|BD/33G|"BD Lancet Device / BD 33 Gauge Lancet.~In Study Visit 1 each subject was randomly assigned to one of four groups, each subject evaluated three different lancet device/lancet combinations. The order of evaluation of the three systems was randomly assigned for each subject. Subjects started at the middle depth setting of each lancet device. The lowest depth setting for each system yielding sufficient volume for each system was recorded for that subject and used during Visit 2. All subjects whom obtained adequate sample volumes were selected to participate in Study Visit 2."
1030523|NCT00741390|E4|Reported Event|Arm D|Visit 1 (V1) Device: BD/33G,OTM/33G,OTM/28G; Visit (V2) Device: OTM/33G,OTM/28G
1030524|NCT00741390|E3|Reported Event|Arm C|Visit 1 (V1) Device: BD/33G,OTM/33G,ACC/28G; Visit 2 (V2)-BD/33G,ACC/28G
1030525|NCT00741390|E2|Reported Event|Arm B|Visit 1 (V1) Device: BD/33G,OTM/33G,OTU/28G; Visit 2 (V2) Device: BD/33G,OTU/28G
1030526|NCT00741390|E1|Reported Event|Arm A|Visit1 (V1) Device: BD/33G,OTM/33G,OTM/28G; Visit2 (V2) Device: BD/33G,OTM/28G
1030527|NCT00741338|B3|Baseline|Total|Total of all reporting groups
1030528|NCT00741338|B2|Baseline|Cohort 2|TIP: CsA starting at 6.7 mg/kg orally three times daily until the target trough concentration of at least 350 ng/mL (preferably 400 ng/mL) achieved along with Aza 5 mg/kg orally every other day. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly IV infusion (starting from Day 1) up to Week 18. CsA and Aza were gradually discontinued. ICP: following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 45.
1030529|NCT00741338|B1|Baseline|Cohort 1|Tolerance Induction Period (TIP): Cyclosporine A (CsA) starting at 5 milligram per kilogram (mg/kg) orally three times daily until the target trough concentration of at least 350 nanogram per milliliter (ng/mL) (preferably 400 ng/mL) achieved along with azathioprine (Aza) 2.5 mg/kg/day orally. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly intravenous (IV) infusion (starting from Day 1) up to Week 12. CsA and Aza were gradually discontinued. Immune Challenge Period (ICP): following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 39.
1030530|NCT00741338|P2|Participant Flow|Cohort 2|TIP: CsA starting at 6.7 mg/kg orally three times daily until the target trough concentration of at least 350 ng/mL (preferably 400 ng/mL) achieved along with Aza 5 mg/kg orally every other day. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly IV infusion (starting from Day 1) up to Week 18. CsA and Aza were gradually discontinued. ICP: following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 45.
1030531|NCT00741338|P1|Participant Flow|Cohort 1|Tolerance Induction Period (TIP): Cyclosporine A (CsA) starting at 5 milligram per kilogram (mg/kg) orally three times daily until the target trough concentration of at least 350 nanogram per milliliter (ng/mL) (preferably 400 ng/mL) achieved along with azathioprine (Aza) 2.5 mg/kg/day orally. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly intravenous (IV) infusion (starting from Day 1) up to Week 12. CsA and Aza were gradually discontinued. Immune Challenge Period (ICP): following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 39.
1030532|NCT00741338|O2|Outcome|Cohort 2|TIP: CsA starting at 6.7 mg/kg orally three times daily until the target trough concentration of at least 350 ng/mL (preferably 400 ng/mL) achieved along with Aza 5 mg/kg orally every other day. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly IV infusion (starting from Day 1) up to Week 18. CsA and Aza were gradually discontinued. ICP: following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 45.
1030533|NCT00741338|O1|Outcome|Cohort 1|Tolerance Induction Period (TIP): Cyclosporine A (CsA) starting at 5 milligram per kilogram (mg/kg) orally three times daily until the target trough concentration of at least 350 nanogram per milliliter (ng/mL) (preferably 400 ng/mL) achieved along with azathioprine (Aza) 2.5 mg/kg/day orally. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly intravenous (IV) infusion (starting from Day 1) up to Week 12. CsA and Aza were gradually discontinued. Immune Challenge Period (ICP): following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 39.
1030534|NCT00741338|O2|Outcome|Cohort 2|TIP: CsA starting at 6.7 mg/kg orally three times daily until the target trough concentration of at least 350 ng/mL (preferably 400 ng/mL) achieved along with Aza 5 mg/kg orally every other day. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly IV infusion (starting from Day 1) up to Week 18. CsA and Aza were gradually discontinued. ICP: following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 45.
1030535|NCT00741338|O1|Outcome|Cohort 1|Tolerance Induction Period (TIP): Cyclosporine A (CsA) starting at 5 milligram per kilogram (mg/kg) orally three times daily until the target trough concentration of at least 350 nanogram per milliliter (ng/mL) (preferably 400 ng/mL) achieved along with azathioprine (Aza) 2.5 mg/kg/day orally. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly intravenous (IV) infusion (starting from Day 1) up to Week 12. CsA and Aza were gradually discontinued. Immune Challenge Period (ICP): following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 39.
1030584|NCT00741104|P1|Participant Flow|RA Patients|Patients on maintenance therapy for rheumatoid arthritis (RA) with infliximab for >= the past 12 months.
1075906|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
1030536|NCT00741338|E2|Reported Event|Cohort 2|TIP: CsA starting at 6.7 mg/kg orally three times daily until the target trough concentration of at least 350 ng/mL (preferably 400 ng/mL) achieved along with Aza 5 mg/kg orally every other day. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low- dose) once weekly IV infusion (starting from Day 1) up to Week 18. CsA and Aza were gradually discontinued. ICP: following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 45.
1030537|NCT00741338|E1|Reported Event|Cohort 1|Tolerance Induction Period (TIP): Cyclosporine A (CsA) starting at 5 milligram per kilogram (mg/kg) orally three times daily until the target trough concentration of at least 350 nanogram per milliliter (ng/mL) (preferably 400 ng/mL) achieved along with azathioprine (Aza) 2.5 mg/kg/day orally. Once target CsA trough level achieved and maintained for at least 1 week, participants received laronidase 0.058 mg/kg (low-dose) once weekly intravenous (IV) infusion (starting from Day 1) up to Week 12. CsA and Aza were gradually discontinued. Immune Challenge Period (ICP): following TIP, laronidase dose increased to 0.12 mg/kg once weekly IV infusion for 1 week followed by 0.25 mg/kg once weekly IV infusion for 1 week and then 0.58 mg/kg (full-dose) once weekly IV infusion up to Week 39.
1030538|NCT00741286|B3|Baseline|Total|Total of all reporting groups
1030539|NCT00741286|B2|Baseline|Asprin Plus Cilostazol|Cilostazol (100mg) twice a day on top of aspirin 100mg a day
1030540|NCT00741286|B1|Baseline|Asprin Plus Placebo|Placebo twice a day on top of aspirin 100mg a day
1030541|NCT00741286|P2|Participant Flow|Asprin Plus Cilostazol|Cilostazol (100mg) twice a day on top of aspirin 100mg a day
1030542|NCT00741286|P1|Participant Flow|Asprin Plus Placebo|Placebo twice a day on top of aspirin 100mg a day
1030543|NCT00741286|O2|Outcome|Asprin Plus Cilostazol|Cilostazol (100mg) twice a day on top of aspirin 100mg a day
1030544|NCT00741286|O1|Outcome|Asprin Plus Placebo|Placebo twice a day on top of aspirin 100mg a day
1030545|NCT00741286|O2|Outcome|Asprin Plus Cilostazol|Cilostazol (100mg) twice a day on top of aspirin 100mg a day
1030546|NCT00741286|O1|Outcome|Asprin Plus Placebo|Placebo twice a day on top of aspirin 100mg a day
1030547|NCT00741286|E2|Reported Event|Asprin Plus Cilostazol|Cilostazol (100mg) twice a day on top of aspirin 100mg a day
1030548|NCT00741286|E1|Reported Event|Asprin Plus Placebo|Placebo twice a day on top of aspirin 100mg a day
1030549|NCT00741273|B3|Baseline|Total|Total of all reporting groups
1030550|NCT00741273|B2|Baseline|Mpaired|Hepatically impaired females
1030551|NCT00741273|B1|Baseline|Healthy|Healthy females
1030552|NCT00741273|P2|Participant Flow|Impaired|Proellex single dose each of 25 mg and 50 mg in hepatically impaired females
1030553|NCT00741273|P1|Participant Flow|Healthy|Proellex single dose each of 25 mg and 50 mg in healthy females
1030554|NCT00741273|O4|Outcome|50 mg Impaired|"Proellex 50 mg in impaired females~Proellex: Proellex 50 mg capsule, single dose"
1030555|NCT00741273|O3|Outcome|Proellex 50 mg Healthy|"Proellex 50 mg in healthy females~Proellex: Proellex 50 mg capsule, single dose"
1030556|NCT00741273|O2|Outcome|Proellex 25 mg Impaired|"Proellex 25 mg in hepatically impaired females~Proellex: Proellex 25 mg capsule, single dose"
1030557|NCT00741273|O1|Outcome|Proellex 25 mg Healthy|"Proellex 25 mg in healthy females~Proellex: Proellex 25 mg capsule, single dose"
1030558|NCT00741273|O4|Outcome|50 mg Impaired|"Proellex 50 mg in impaired females~Proellex: Proellex 50 mg capsule, single dose"
1030559|NCT00741273|O3|Outcome|Proellex 50 mg Healthy|"Proellex 50 mg in healthy females~Proellex: Proellex 50 mg capsule, single dose"
1030560|NCT00741273|O2|Outcome|Proellex 25 mg Impaired|"Proellex 25 mg in hepatically impaired females~Proellex: Proellex 25 mg capsule, single dose"
1030561|NCT00741273|O1|Outcome|Proellex 25 mg Healthy|"Proellex 25 mg in healthy females~Proellex: Proellex 25 mg capsule, single dose"
1030562|NCT00741273|O4|Outcome|Proellex 50 mg Impaired|"Proellex 50 mg in impaired females~Proellex: Proellex 50 mg capsule, single dose"
1030563|NCT00741273|O3|Outcome|Proellex 50 mg Healthy|"Proellex 50 mg in healthy females~Proellex: Proellex 50 mg capsule, single dose"
1030564|NCT00741273|O2|Outcome|Proellex 25 mg Impaired|"Proellex 50 mg in hepatically impaired females~Proellex: Proellex 25 mg capsule, single dose"
1030565|NCT00741273|O1|Outcome|Proellex 25 mg Healthy|"Proellex 25 mg in healthy females~Proellex: Proellex 25 mg capsule, single dose"
1030566|NCT00741273|E2|Reported Event|Proellex Impaired|"Proellex 25 mg and 50 mg in hepatically impaired females~Proellex: Proellex 25 mg and 50 mg capsule, single dose each"
1030567|NCT00741273|E1|Reported Event|Proellex Healthy|"Proellex 25 mg and 50 mg in healthy females~Proellex: Proellex 25 mg and 50 mg capsule, single dose each"
1030568|NCT00741156|B1|Baseline|Enalaprilat|Enalaprilat : Enalaprilat will be administered intravenously i.v. 0.01 mg/kg i.v. over 1 minute
1030569|NCT00741156|P1|Participant Flow|Enalaprilat|Enalaprilat : Enalaprilat will be administered intravenously i.v. 0.01 mg/kg i.v. over 1 minute
1030570|NCT00741156|O6|Outcome|Cerebral Resistance After Enalaprilat|cerebral resistance is measured after enalaprilat
1030571|NCT00741156|O5|Outcome|Cerebral Resistance at Baseline|cerebral resistance is measured in baseline condition
1030572|NCT00741156|O4|Outcome|Pulmonary Resistance After Enalaprilat|pulmonary resistance is measured after enalaprilat
1030573|NCT00741156|O3|Outcome|Pulmonary Resistance at Baseline|pulmonary resistance at baseline is measured
1030574|NCT00741156|O2|Outcome|Systemic Resistance After Enalaprilat|systemic resistance is measured after enalaprilat
1030575|NCT00741156|O1|Outcome|Systemic Resistance at Baseline|systemic resistance in baseline condition
1030578|NCT00741156|O4|Outcome|Pulmonary Blood Flow After Enaliprilat|Pulmonary blood flow 20 minutes after enalaprilat
1030579|NCT00741156|O3|Outcome|Pulmonary Blood Flow Baseline|Pulmonary blood flow baseline condition
1030580|NCT00741156|O2|Outcome|Systemic Blood Flow After Enalaprilat|Systemic blood flow 20 minutes after enalaprilat
1030581|NCT00741156|O1|Outcome|Systemic Blood Flow Baseline|Systemic blood flow in baseline condition
1030582|NCT00741156|E1|Reported Event|Enalaprilat|Enalaprilat : Enalaprilat will be administered intravenously i.v. 0.01 mg/kg i.v. over 1 minute
1030583|NCT00741104|B1|Baseline|RA Patients|Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for >= the past 12 months.
1030585|NCT00741104|O1|Outcome|RA Patients|Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for >= the past 12 months.
1030586|NCT00741104|O1|Outcome|RA Patients|Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for >= the past 12 months.
1030587|NCT00741104|O1|Outcome|RA Patients|Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for >= the past 12 months.
1030588|NCT00741104|O1|Outcome|RA Patients|Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for >= the past 12 months.
1030589|NCT00741104|E1|Reported Event|RA Patients|Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for >= the past 12 months.
1030590|NCT00741091|B1|Baseline|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
1030591|NCT00741091|P1|Participant Flow|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
1030592|NCT00741091|O1|Outcome|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
1030593|NCT00741091|O1|Outcome|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
1030594|NCT00741091|O1|Outcome|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
1030595|NCT00741091|O1|Outcome|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
1030596|NCT00741091|O1|Outcome|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
1030597|NCT00741091|E1|Reported Event|Carotid WALLSTENT Endoprothesis and FilterWire EZ System|Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
1030598|NCT00741039|B3|Baseline|Total|Total of all reporting groups
1030599|NCT00741039|B2|Baseline|Healthy Volunteers|Vaccine Responses Against Pneumococcus and Influenza in Adults 65 Years of Age and Older
1030600|NCT00741039|B1|Baseline|Adult Cancer Patients 65 Years of Age and Older|Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older
1030601|NCT00741039|P2|Participant Flow|Healthy Volunteers|Vaccine Responses Against Pneumococcus and Influenza in Adults 65 Years of Age and Older
1030602|NCT00741039|P1|Participant Flow|Adult Cancer Patients 65 Years of Age and Older|Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older
1030603|NCT00741039|O2|Outcome|Healthy Volunteers|Vaccine Responses Against Pneumococcus and Influenza in Adults 65 Years of Age and Older
1030604|NCT00741039|O1|Outcome|Adult Cancer Patients 65 Years of Age and Older|Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older
1030605|NCT00741039|E2|Reported Event|Healthy Volunteers|Vaccine Responses Against Pneumococcus and Influenza in Adults 65 Years of Age and Older
1030606|NCT00741039|E1|Reported Event|Adult Cancer Patients 65 Years of Age and Older|Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older
1030607|NCT00741026|B1|Baseline|Placebo / Olanzapine|"Participants that were randomized to Placebo (Sugar Pill) treatment for three days and then a washout period of at least two weeks but not more than 4 weeks before Olanzapine treatment, 10 mg olanzapine by mouth at bedtime for three consecutive nights.~OR~Participants that were randomized to Olanzapine, 10 mg olanzapine by mouth at bedtime for three consecutive nights before a washout period of at least two weeks but not more than 4 weeks before Placebo treatment (Sugar Pill) for three days."
1030608|NCT00741026|P1|Participant Flow|Placebo / Olanzapine|"Participants that were randomized to Placebo (Sugar Pill) treatment for three days and then a washout period of at least two weeks but not more than 4 weeks before Olanzapine treatment, 10 mg olanzapine by mouth at bedtime for three consecutive nights.~OR~Participants that were randomized to Olanzapine, 10 mg olanzapine by mouth at bedtime for three consecutive nights before a washout period of at least two weeks but not more than 4 weeks before Placebo treatment (Sugar Pill) for three days.~Randomization information not available."
1030609|NCT00741026|O2|Outcome|Olanzapine|
1030610|NCT00741026|O1|Outcome|Placebo|
1030611|NCT00741026|O2|Outcome|Olanzapine|
1030612|NCT00741026|O1|Outcome|Placebo|
1030613|NCT00741026|O2|Outcome|Olanzapine|
1030614|NCT00741026|O1|Outcome|Placebo|
1030615|NCT00741026|O2|Outcome|Olanzapine|
1030616|NCT00741026|O1|Outcome|Placebo|
1030617|NCT00741026|O2|Outcome|Olanzapine|
1030618|NCT00741026|O1|Outcome|Placebo|
1030619|NCT00741026|O2|Outcome|Olanzapine|
1030620|NCT00741026|O1|Outcome|Placebo|
1030621|NCT00741026|O2|Outcome|Olanzapine|
1030622|NCT00741026|O1|Outcome|Placebo|
1030623|NCT00741026|O2|Outcome|Olanzapine|
1030624|NCT00741026|O1|Outcome|Placebo|
1030625|NCT00741026|O2|Outcome|Olanzapine|
1030634|NCT00741026|E1|Reported Event|Placebo|Placebo : (1) placebo tablets administered orally before bed for three consecutive evenings (Total Dose = 3 tablets)
1030635|NCT00741013|B4|Baseline|Total|Total of all reporting groups
1030636|NCT00741013|B3|Baseline|Placebo Pill and Recombinant Human Activated Protein C i.v.|Group receiving recombinant human activated protein C (rhAPC) as the drug intervention
1030637|NCT00741013|B2|Baseline|Lovastatin Pill and i.v. Placebo|Group receiving lovastatin as the primary drug intervention
1030638|NCT00741013|B1|Baseline|Placebo Pill and Intravenous (i.v.) Placebo|Control group receiving only placebo drug interventions
1030639|NCT00741013|P3|Participant Flow|Placebo Pill and Recombinant Human Activated Protein C i.v.|Group receiving recombinant human activated protein C (rhAPC) as the drug intervention
1030904|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
1030640|NCT00741013|P2|Participant Flow|Lovastatin Pill and i.v. Placebo|Group receiving lovastatin as the primary drug intervention
1030641|NCT00741013|P1|Participant Flow|Placebo Pill and Intravenous (i.v.) Placebo|Control group receiving only placebo drug interventions
1030642|NCT00741013|O3|Outcome|Placebo Pill and Recombinant Human Activated Protein C i.v.|Group receiving recombinant human activated protein C (rhAPC) as the drug intervention
1030643|NCT00741013|O2|Outcome|Lovastatin Pill and i.v. Placebo|Group receiving lovastatin as the primary drug intervention
1030644|NCT00741013|O1|Outcome|Placebo Pill and Intravenous (i.v.) Placebo|Control group receiving only placebo drug interventions
1030645|NCT00741013|O3|Outcome|Placebo Pill and Recombinant Human Activated Protein C i.v.|Group receiving recombinant human activated protein C (rhAPC) as the drug intervention
1030646|NCT00741013|O2|Outcome|Lovastatin Pill and i.v. Placebo|Group receiving lovastatin as the primary drug intervention
1030647|NCT00741013|O1|Outcome|Placebo Pill and Intravenous (i.v.) Placebo|Control group receiving only placebo drug interventions
1030648|NCT00741013|E3|Reported Event|Placebo Pill and Recombinant Human Activated Protein C i.v.|Group receiving recombinant human activated protein C (rhAPC) as the drug intervention
1030649|NCT00741013|E2|Reported Event|Lovastatin Pill and i.v. Placebo|Group receiving lovastatin as the primary drug intervention
1030650|NCT00741013|E1|Reported Event|Placebo Pill and Intravenous (i.v.) Placebo|Control group receiving only placebo drug interventions
1030651|NCT00740857|B4|Baseline|Total|Total of all reporting groups
1030652|NCT00740857|B3|Baseline|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
1030653|NCT00740857|B2|Baseline|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
1030654|NCT00740857|B1|Baseline|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
1030655|NCT00740857|P3|Participant Flow|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
1030656|NCT00740857|P2|Participant Flow|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
1030657|NCT00740857|P1|Participant Flow|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
1030658|NCT00740857|O3|Outcome|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
1030659|NCT00740857|O2|Outcome|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
1030660|NCT00740857|O1|Outcome|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
1030661|NCT00740857|O3|Outcome|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
1030662|NCT00740857|O2|Outcome|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
1030663|NCT00740857|O1|Outcome|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
1030664|NCT00740857|O3|Outcome|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
1030665|NCT00740857|O2|Outcome|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
1030666|NCT00740857|O1|Outcome|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
1030667|NCT00740857|O3|Outcome|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
1030668|NCT00740857|O2|Outcome|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
1030669|NCT00740857|O1|Outcome|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
1030670|NCT00740857|O3|Outcome|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
1030671|NCT00740857|O2|Outcome|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
1030672|NCT00740857|O1|Outcome|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
1030673|NCT00740857|O3|Outcome|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
1030674|NCT00740857|O2|Outcome|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
1030675|NCT00740857|O1|Outcome|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
1030676|NCT00740857|O3|Outcome|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
1030677|NCT00740857|O2|Outcome|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
1030678|NCT00740857|O1|Outcome|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
1030679|NCT00740857|O3|Outcome|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
1030680|NCT00740857|O2|Outcome|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
1030681|NCT00740857|O1|Outcome|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
1030682|NCT00740857|E3|Reported Event|Ibuprofen Formulation 2|2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery
1030683|NCT00740857|E2|Reported Event|Ibuprofen Formulation 1|2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery
1030684|NCT00740857|E1|Reported Event|Placebo|2 placebo gel capsules delivered as a single dose up to 5 hours after surgery
1030685|NCT00740831|B4|Baseline|Total|Total of all reporting groups
1030686|NCT00740831|B3|Baseline|C (GnRH-agonist)|PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
1030687|NCT00740831|B2|Baseline|B (PGL4001 10mg)|Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
1030688|NCT00740831|B1|Baseline|A (PGL4001 5mg)|Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
1030689|NCT00740831|P3|Participant Flow|C (GnRH-agonist)|PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
1030690|NCT00740831|P2|Participant Flow|B (PGL4001 10mg)|Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
1030691|NCT00740831|P1|Participant Flow|A (PGL4001 5mg)|Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
1032213|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
1030692|NCT00740831|O3|Outcome|C (GnRH-agonist)|PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
1030693|NCT00740831|O2|Outcome|B (PGL4001 10mg)|Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
1030694|NCT00740831|O1|Outcome|A (PGL4001 5mg)|Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
1030695|NCT00740831|O3|Outcome|C (GnRH-agonist)|PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
1030696|NCT00740831|O2|Outcome|B (PGL4001 10mg)|Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
1030697|NCT00740831|O1|Outcome|A (PGL4001 5mg)|Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
1030698|NCT00740831|O3|Outcome|C (GnRH-agonist)|PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
1030699|NCT00740831|O2|Outcome|B (PGL4001 10mg)|Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
1030700|NCT00740831|O1|Outcome|A (PGL4001 5mg)|Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
1030701|NCT00740831|O3|Outcome|C (GnRH-agonist)|PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
1030702|NCT00740831|O2|Outcome|B (PGL4001 10mg)|Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
1030703|NCT00740831|O1|Outcome|A (PGL4001 5mg)|Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
1030704|NCT00740831|E3|Reported Event|C (GnRH-agonist)|PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
1030705|NCT00740831|E2|Reported Event|B (PGL4001 10mg)|Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
1030706|NCT00740831|E1|Reported Event|A (PGL4001 5mg)|Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
1030707|NCT00740792|B5|Baseline|Total|Total of all reporting groups
1030708|NCT00740792|B4|Baseline|Placebo|placebo control
1030709|NCT00740792|B3|Baseline|Fluticasone Propionate|active comparator of fluticasone propionate
1030710|NCT00740792|B2|Baseline|Azelastine HCL|active comparator of azelastine HCl
1030711|NCT00740792|B1|Baseline|MP29-02|azelastine HCl/fluticasone propionate
1030712|NCT00740792|P4|Participant Flow|Placebo|placebo control
1030713|NCT00740792|P3|Participant Flow|Fluticasone Propionate|active comparator of fluticasone propionate
1030714|NCT00740792|P2|Participant Flow|Azelastine HCL|active comparator of azelastine HCl
1030715|NCT00740792|P1|Participant Flow|MP29-02|azelastine HCl/fluticasone propionate
1030716|NCT00740792|O4|Outcome|Placebo|placebo control
1030717|NCT00740792|O3|Outcome|Fluticasone Propionate|active comparator of fluticasone propionate
1030718|NCT00740792|O2|Outcome|Azelastine HCL|active comparator of azelastine HCl
1030719|NCT00740792|O1|Outcome|MP29-02|azelastine HCl/fluticasone propionate
1030720|NCT00740792|O4|Outcome|Placebo|placebo control
1030721|NCT00740792|O3|Outcome|Fluticasone Propionate|active comparator of fluticasone propionate
1030722|NCT00740792|O2|Outcome|Azelastine HCL|active comparator of azelastine HCl
1030723|NCT00740792|O1|Outcome|MP29-02|azelastine HCl/fluticasone propionate
1030724|NCT00740792|O4|Outcome|Placebo|placebo control
1030725|NCT00740792|O3|Outcome|Fluticasone Propionate|active comparator of fluticasone propionate
1030726|NCT00740792|O2|Outcome|Azelastine HCL|active comparator of azelastine HCl
1030727|NCT00740792|O1|Outcome|MP29-02|azelastine HCl/fluticasone propionate
1030728|NCT00740792|E4|Reported Event|Placebo|placebo control
1030729|NCT00740792|E3|Reported Event|Fluticasone Propionate|active comparator of fluticasone propionate
1030730|NCT00740792|E2|Reported Event|Azelastine HCL|active comparator of azelastine HCl
1030731|NCT00740792|E1|Reported Event|MP29-02|azelastine HCl/fluticasone propionate
1030732|NCT00740779|B4|Baseline|Total|Total of all reporting groups
1030733|NCT00740779|B3|Baseline|Placebo|1 placebo capsule daily
1030734|NCT00740779|B2|Baseline|Silodosin 8 mg|Silodosin 8 mg daily
1030735|NCT00740779|B1|Baseline|Silodosin 4 mg|Silodosin 4 mg daily
1030736|NCT00740779|P3|Participant Flow|Placebo|1 placebo capsule daily
1030737|NCT00740779|P2|Participant Flow|Silodosin 8 mg|Silodosin 8 mg daily
1030738|NCT00740779|P1|Participant Flow|Silodosin 4 mg|Silodosin 4 mg daily
1030739|NCT00740779|O3|Outcome|Placebo|1 placebo capsule daily
1030740|NCT00740779|O2|Outcome|Silodosin 8 mg|Silodosin 8 mg daily
1030741|NCT00740779|O1|Outcome|Silodosin 4 mg|Silodosin 4 mg daily
1030742|NCT00740779|E3|Reported Event|Placebo|1 placebo capsule daily
1030743|NCT00740779|E2|Reported Event|Silodosin 8 mg|Silodosin 8 mg daily
1030744|NCT00740779|E1|Reported Event|Silodosin 4 mg|Silodosin 4 mg daily
1030745|NCT00740727|B1|Baseline|EASI/HRH(Human Recombinant Hyaluronidase)|Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters
1030746|NCT00740727|P1|Participant Flow|EASI/HRH(Human Recombinant Hyaluronidase)|Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters
1030747|NCT00740727|O1|Outcome|EASI/HRH(Human Recombinant Hyaluronidase)|Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters
1030748|NCT00740727|O1|Outcome|EASI/HRH(Human Recombinant Hyaluronidase)|Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters
1030749|NCT00740727|O1|Outcome|EASI/HRH(Human Recombinant Hyaluronidase)|Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters
1030750|NCT00740727|O1|Outcome|EASI/HRH(Human Recombinant Hyaluronidase)|Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters
1030751|NCT00740714|B4|Baseline|Total|Total of all reporting groups
1030752|NCT00740714|B3|Baseline|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
1030753|NCT00740714|B2|Baseline|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
1075907|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
1030754|NCT00740714|B1|Baseline|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
1030755|NCT00740714|P3|Participant Flow|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
1030756|NCT00740714|P2|Participant Flow|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
1030757|NCT00740714|P1|Participant Flow|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
1030758|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
1030759|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
1030760|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
1030761|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
1030762|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
1030763|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
1030764|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
1030765|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
1030766|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
1030767|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
1030768|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
1030769|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
1030770|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
1030771|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
1030772|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
1030773|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
1030774|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
1030775|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
1030776|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
1030777|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
1030778|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
1030779|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
1030780|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
1030781|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
1030782|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
1030783|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
1030784|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
1030785|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
1030786|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
1030787|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
1030788|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
1030789|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
1030790|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
1030791|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
1030792|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
1030793|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
1030794|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
1031511|NCT00738426|P2|Participant Flow|Sham Device|"non-therapeutic sham light output~Sham device: non-therapeutic light energy output"
1030795|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
1030796|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
1030797|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
1030798|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
1075908|NCT00623779|E3|Reported Event|Standard Therapy|Standard Therapy
1030799|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
1030800|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
1030801|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
1030802|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
1030803|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
1030804|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
1030805|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
1030806|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
1030807|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
1030808|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
1030809|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
1030810|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
1030811|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
1030812|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
1030813|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
1030814|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
1030815|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
1030816|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
1030817|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
1030818|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
1030819|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
1030820|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
1030821|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
1030822|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
1030823|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
1030824|NCT00740714|O3|Outcome|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
1030825|NCT00740714|O2|Outcome|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
1030826|NCT00740714|O1|Outcome|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
1030827|NCT00740714|E3|Reported Event|C. Placebo With Vitamin E 1200 IU/Day|Placebo (with vitamin E 1200 IU/day)
1030828|NCT00740714|E2|Reported Event|B. Coenzyme Q10 1200 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 1200 mg/day with vitamin E 1200 IU/day)
1030829|NCT00740714|E1|Reported Event|A. Coenzyme Q10 2400 mg/Day With Vitamin E 1200 IU/Day|Randomized to active treatment (Coenzyme Q10 2400 mg/day with vitamin E 1200 IU/day)
1030830|NCT00740636|B3|Baseline|Total|Total of all reporting groups
1030831|NCT00740636|B2|Baseline|75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles.|75 mg/m2/day for 21 days (7 days off treatment). 28 day cycles.
1030832|NCT00740636|B1|Baseline|200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles.|200 mg/m2/day for 5 days (23 days off treatment). 28 day cycles.
1030833|NCT00740636|P2|Participant Flow|75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles.|75 mg/m2/day for 21 days (7 days off treatment). 28 day cycles.
1030834|NCT00740636|P1|Participant Flow|200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles.|200 mg/m2/day for 5 days (23 days off treatment). 28 day cycles.
1030835|NCT00740636|O2|Outcome|75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles.|75 mg/m2/day for 21 days (7 days off treatment). 28 day cycles.
1030836|NCT00740636|O1|Outcome|200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles.|200 mg/m2/day for 5 days (23 days off treatment). 28 day cycles.
1030837|NCT00740636|E2|Reported Event|75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles.|75 mg/m2/day for 21 days (7 days off treatment). 28 day cycles.
1030838|NCT00740636|E1|Reported Event|200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles.|200 mg/m2/day for 5 days (23 days off treatment). 28 day cycles.
1030839|NCT00740597|B1|Baseline|Arm 1|pre-operative radiation + surgery PTV will receive a total dose of 50 Gy in 25 fractions, 2 Gy per fraction, 5 fractions per week, over approximately 5 weeks. Concurrently, the GTV2, if present, will receive 54 Gy in 25 fraction. Dose will be prescribed to the isodose volume that encompasses the PTV. All patients will be treated by 6 MV photon beam.
1030840|NCT00740597|P1|Participant Flow|Arm 1|pre-operative radiation + surgery PTV will receive a total dose of 50 Gy in 25 fractions, 2 Gy per fraction, 5 fractions per week, over approximately 5 weeks. Concurrently, the GTV2, if present, will receive 54 Gy in 25 fraction. Dose will be prescribed to the isodose volume that encompasses the PTV. All patients will be treated by 6 MV photon beam.
1030905|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030841|NCT00740597|O1|Outcome|Arm 1|pre-operative radiation + surgery PTV will receive a total dose of 50 Gy in 25 fractions, 2 Gy per fraction, 5 fractions per week, over approximately 5 weeks. Concurrently, the GTV2, if present, will receive 54 Gy in 25 fraction. Dose will be prescribed to the isodose volume that encompasses the PTV. All patients will be treated by 6 MV photon beam.
1030842|NCT00740597|E1|Reported Event|Arm 1|pre-operative radiation + surgery PTV will receive a total dose of 50 Gy in 25 fractions, 2 Gy per fraction, 5 fractions per week, over approximately 5 weeks. Concurrently, the GTV2, if present, will receive 54 Gy in 25 fraction. Dose will be prescribed to the isodose volume that encompasses the PTV. All patients will be treated by 6 MV photon beam.
1030843|NCT00740584|B1|Baseline|Open Label, Only Arm|3%w/w SPL7013 vaginal gel (VivaGel)
1030844|NCT00740584|P1|Participant Flow|Open Label, Only Arm|3%w/w SPL7013 vaginal gel (VivaGel)
1030845|NCT00740584|O1|Outcome|Open Label Active|
1030846|NCT00740584|E1|Reported Event|Open Label, Only Arm|3%w/w SPL7013 vaginal gel (VivaGel)
1030847|NCT00740480|B1|Baseline|Septal Stapler Group|Adult population (ages 18-65) with clinically significant nasal septum deviation.
1030848|NCT00740480|P1|Participant Flow|Septal Stapler Group|Adult population (ages 18-65) with clinically significant nasal septum deviation.
1030849|NCT00740480|O1|Outcome|Septal Stapler Group|Adult population (ages 18-65) with clinically significant nasal septum deviation.
1030850|NCT00740480|O1|Outcome|Septal Stapler Group|Adult population (ages 18-65) with clinically significant nasal septum deviation.
1030851|NCT00740220|B1|Baseline|Single Arm Prospective Observational Study|Each subject will be their own control. Each subject will perform three 6MWTs. Intra-subject reproducibility is being tested. These will all be subjects in Pulmonary Rehab.
1030852|NCT00740220|P1|Participant Flow|Single Arm Prospective Observational Study|Each subject will be their own control. Each subject will perform three 6MWTs. Intra-subject reproducibility is being tested. These will all be subjects in Pulmonary Rehab.
1030853|NCT00740220|O1|Outcome|Single Arm Prospective Observational Study|Each subject will be their own control. Each subject will perform three 6MWTs. Intra-subject reproducibility is being tested. These will all be subjects in Pulmonary Rehab.
1030854|NCT00740220|E1|Reported Event|Single Arm Prospective Observational Study|Each subject will be their own control. Each subject will perform three 6MWTs. Intra-subject reproducibility is being tested. These will all be subjects in Pulmonary Rehab.
1030855|NCT00740207|B3|Baseline|Total|Total of all reporting groups
1030856|NCT00740207|B2|Baseline|VISIPAQUE 270|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
1030857|NCT00740207|B1|Baseline|ISOVUE 250|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
1030858|NCT00740207|P2|Participant Flow|VISIPAQUE 270|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
1030859|NCT00740207|P1|Participant Flow|ISOVUE 250|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
1030860|NCT00740207|O2|Outcome|VISIPAQUE 270|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
1030861|NCT00740207|O1|Outcome|ISOVUE 250|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
1030862|NCT00740207|O2|Outcome|VISIPAQUE 270|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
1030863|NCT00740207|O1|Outcome|ISOVUE 250|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
1030864|NCT00740207|O4|Outcome|VAS Score After Injection of VISIPAQUE 270|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
1030865|NCT00740207|O3|Outcome|VAS Score Prior to Injection of VISIPAQUE 270|Pain Severity Scale: (0) None = VAS Score 0; (1) Mild = VAS Score 1-3; (2) Moderate = VAS Score 4-6; (3) Severe = VAS Score 7-10.
1030906|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
1032214|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
1030866|NCT00740207|O2|Outcome|VAS Score After Injection of ISOVUE 250|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
1030867|NCT00740207|O1|Outcome|VAS Score Prior to Injection of ISOVUE 250|Pain Severity Scale: (0) None = VAS Score 0; (1) Mild = VAS Score 1-3; (2) Moderate = VAS Score 4-6; (3) Severe = VAS Score 7-10.
1030868|NCT00740207|E2|Reported Event|VISIPAQUE 270|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
1030869|NCT00740207|E1|Reported Event|ISOVUE 250|Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
1030870|NCT00740181|B1|Baseline|Chemotherapy|Decitabine 20 mg/m2 IV over 1 hr days 1-5 Cytarabine 20 mg/m2 subcut days 1-5 G-CSF 5mcg/kg subcut days 1-5
1030871|NCT00740181|P1|Participant Flow|Chemotherapy|Decitabine 20 mg/m2 IV over 1 hr days 1-5 Cytarabine 20 mg/m2 subcut days 1-5 G-CSF 5mcg/kg subcut days 1-5
1030872|NCT00740181|O1|Outcome|Chemotherapy|Decitabine 20 mg/m2 IV over 1 hr days 1-5 Cytarabine 20 mg/m2 subcut days 1-5 G-CSF 5mcg/kg subcut days 1-5
1030873|NCT00740181|E1|Reported Event|Chemotherapy|Decitabine 20 mg/m2 IV over 1 hr days 1-5 Cytarabine 20 mg/m2 subcut days 1-5 G-CSF 5mcg/kg subcut days 1-5
1030874|NCT00740051|B3|Baseline|Total|Total of all reporting groups
1030875|NCT00740051|B2|Baseline|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
1030876|NCT00740051|B1|Baseline|Placebo/Glimepiride|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
1030877|NCT00740051|P2|Participant Flow|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
1030878|NCT00740051|P1|Participant Flow|Placebo/Glimepiride|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
1030879|NCT00740051|O2|Outcome|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
1030880|NCT00740051|O1|Outcome|Placebo/Glimepiride|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
1030881|NCT00740051|O2|Outcome|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
1030882|NCT00740051|O1|Outcome|Placebo/Glimepiride|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
1030883|NCT00740051|O2|Outcome|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
1030884|NCT00740051|O1|Outcome|Placebo|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
1030885|NCT00740051|O2|Outcome|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
1030886|NCT00740051|O1|Outcome|Placebo|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
1030887|NCT00740051|O2|Outcome|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
1030888|NCT00740051|O1|Outcome|Placebo|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
1030889|NCT00740051|O2|Outcome|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
1030890|NCT00740051|O1|Outcome|Placebo|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
1030891|NCT00740051|O2|Outcome|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
1030892|NCT00740051|O1|Outcome|Placebo|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
1030893|NCT00740051|O2|Outcome|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
1030894|NCT00740051|O1|Outcome|Placebo|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
1030895|NCT00740051|E2|Reported Event|Linagliptin|Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
1030896|NCT00740051|E1|Reported Event|Placebo/Glimepiride|Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
1030897|NCT00739999|B3|Baseline|Total|Total of all reporting groups
1030898|NCT00739999|B2|Baseline|Atorvastatin (10 mg, 20 mg): Tanner Stage 2+|Initial dose 10 mg/day through Week 4; after Week 4 dose may have been doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030899|NCT00739999|B1|Baseline|Atorvastatin (5 mg, 10 mg): Tanner Stage 1|Initial dose 5 mg/day through Week 4; after Week 4 dose may have been doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030900|NCT00739999|P2|Participant Flow|Atorvastatin (10 mg, 20 mg): Tanner Stage 2+|Age 10 - 17 years, at Tanner Stage 2+. Initial dose 10 mg/day through Week 4; after Week 4 dose may have been doubled to 20 mg/day if target LDL-C was not attained.
1030901|NCT00739999|P1|Participant Flow|Atorvastatin (5 mg, 10 mg): Tanner Stage 1|Age 6 - 10 years, at Tanner Stage 1. Initial dose 5 mg/day through Week 4; after Week 4 dose may have been doubled to 10 mg/day if target low-density lipoprotein cholesterol (LDL-C) was not attained.
1030902|NCT00739999|O1|Outcome|Atorvastatin (5 mg, 10 mg, 20 mg): Tanner Stages 1 and 2+|Tanner Stage 1: Initial dose 5 mg/day through Week 4; after Week 4 dose may have been doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated; Tanner Stage 2+: Initial dose 10 mg/day through Week 4; after Week 4 dose may have been doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030903|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030907|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030908|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
1030909|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030910|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
1030911|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030912|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
1030913|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030914|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
1030915|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030916|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
1030917|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030918|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
1030919|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030920|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
1030921|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030922|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
1030923|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030924|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
1030925|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030926|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
1030927|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030928|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
1030929|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030930|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
1030931|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030932|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
1030933|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030934|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
1030935|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030936|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
1030937|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030938|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
1030939|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030940|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
1030941|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030942|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
1030943|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030944|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
1030945|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030947|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030948|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
1030949|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030950|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
1030951|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030952|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
1030953|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030954|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
1030955|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030956|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
1030957|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030958|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
1030959|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030960|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
1030961|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030962|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
1030963|NCT00739999|O4|Outcome|Titrated to 20 mg: Tanner Stage 2+|Atorvastatin: initial dose 10 mg/day through Week 4; after Week 4 dose was doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030964|NCT00739999|O3|Outcome|Stayed at 10 mg: Tanner Stage 2+|Atorvastatin 10 mg/day
1030965|NCT00739999|O2|Outcome|Titrated to 10 mg: Tanner Stage 1|Atorvastatin: initial dose 5 mg/day through Week 4; after Week 4 dose was doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030966|NCT00739999|O1|Outcome|Stayed at 5 mg: Tanner Stage 1|Atorvastatin 5 mg/day
1030967|NCT00739999|O2|Outcome|Atorvastatin (10 mg, 20 mg): Tanner Stage 2+|Initial dose 10 mg/day through Week 4; after Week 4 dose may have been doubled to 20 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030968|NCT00739999|O1|Outcome|Atorvastatin (5 mg, 10 mg): Tanner Stage 1|Initial dose 5 mg/day through Week 4; after Week 4 dose may have been doubled to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030969|NCT00739999|E2|Reported Event|All Subjects (10 mg, 20 mg): Tanner Stage 2+|Atorvastatin: subjects who stayed at initial dose of 10 mg/day for duration of study and subjects who titrated to 20 mg/day after Week 4 if target LDL-C was not attained and study drug was well tolerated.
1030970|NCT00739999|E1|Reported Event|All Subjects (5 mg, 10 mg): Tanner Stage 1|Atorvastatin: subjects who stayed at initial dose of 5 mg/day for duration of study and subjects who titrated after Week 4 to 10 mg/day if target LDL-C was not attained and study drug was well tolerated.
1030971|NCT00739973|B10|Baseline|Total|Total of all reporting groups
1030972|NCT00739973|B9|Baseline|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1030973|NCT00739973|B8|Baseline|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1030974|NCT00739973|B7|Baseline|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1030975|NCT00739973|B6|Baseline|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1030976|NCT00739973|B5|Baseline|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
1031090|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 2 to 7 (up to Day 20 or more if clinically indicated).
1031210|NCT00739596|B2|Baseline|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks
1030977|NCT00739973|B4|Baseline|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031100|NCT00739908|O1|Outcome|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
1030978|NCT00739973|B3|Baseline|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1030979|NCT00739973|B2|Baseline|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1030980|NCT00739973|B1|Baseline|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
1030981|NCT00739973|P9|Participant Flow|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1030982|NCT00739973|P8|Participant Flow|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1030983|NCT00739973|P7|Participant Flow|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1030984|NCT00739973|P6|Participant Flow|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1030985|NCT00739973|P5|Participant Flow|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
1030986|NCT00739973|P4|Participant Flow|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1030987|NCT00739973|P3|Participant Flow|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1030988|NCT00739973|P2|Participant Flow|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1030989|NCT00739973|P1|Participant Flow|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
1030990|NCT00739973|O9|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1030991|NCT00739973|O8|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031091|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 2 to 7 (up to Day 20 or more if clinically indicated).
1034373|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
1031007|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
1030992|NCT00739973|O7|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1030993|NCT00739973|O6|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1030994|NCT00739973|O5|Outcome|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
1030995|NCT00739973|O4|Outcome|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1030996|NCT00739973|O3|Outcome|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1030997|NCT00739973|O2|Outcome|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1030998|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
1030999|NCT00739973|O9|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031000|NCT00739973|O8|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031001|NCT00739973|O7|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031002|NCT00739973|O6|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031003|NCT00739973|O5|Outcome|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
1031004|NCT00739973|O4|Outcome|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031005|NCT00739973|O3|Outcome|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031006|NCT00739973|O2|Outcome|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031092|NCT00739934|E2|Reported Event|Voriconazole Oral|Voriconazole oral maintenance dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
1031008|NCT00739973|O9|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031009|NCT00739973|O8|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031010|NCT00739973|O7|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031011|NCT00739973|O6|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031012|NCT00739973|O5|Outcome|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
1031013|NCT00739973|O4|Outcome|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031014|NCT00739973|O3|Outcome|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031015|NCT00739973|O2|Outcome|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031016|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
1031017|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031018|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
1031019|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031020|NCT00739973|O1|Outcome|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
1031021|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031211|NCT00739596|B1|Baseline|Aliskiren HCTZ|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
1031022|NCT00739973|O1|Outcome|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031023|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031024|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
1031025|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031026|NCT00739973|O1|Outcome|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031027|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031028|NCT00739973|O1|Outcome|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031029|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031030|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
1031031|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031032|NCT00739973|O1|Outcome|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
1031033|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031034|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
1031035|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031036|NCT00739973|O1|Outcome|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
1031093|NCT00739934|E1|Reported Event|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated).
1031052|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
1031037|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031038|NCT00739973|O1|Outcome|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031039|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031040|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
1031041|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031042|NCT00739973|O1|Outcome|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031043|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 300/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031044|NCT00739973|O1|Outcome|Aliskiren 300 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031045|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031046|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
1031047|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031048|NCT00739973|O1|Outcome|Amlodipine 10 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
1031049|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031050|NCT00739973|O1|Outcome|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031051|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031094|NCT00739908|B3|Baseline|Total|Total of all reporting groups
1031095|NCT00739908|B2|Baseline|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
1034374|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
1031053|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031054|NCT00739973|O1|Outcome|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031055|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031056|NCT00739973|O1|Outcome|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031057|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/10 mg|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031058|NCT00739973|O1|Outcome|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031059|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031060|NCT00739973|O1|Outcome|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
1031061|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031062|NCT00739973|O1|Outcome|Amlodipine 5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031063|NCT00739973|O2|Outcome|Aliskiren/Amlodipine 150/5 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031064|NCT00739973|O1|Outcome|Aliskiren 150 mg|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031065|NCT00739973|E9|Reported Event|Aliskiren/Amlodipine 300/10 mg Tablet|300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031066|NCT00739973|E8|Reported Event|Aliskiren/Amlodipine 300/5 mg Tablet|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031096|NCT00739908|B1|Baseline|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
1031097|NCT00739908|P2|Participant Flow|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
1032203|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
1031098|NCT00739908|P1|Participant Flow|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
1031099|NCT00739908|O2|Outcome|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
1075909|NCT00623779|E2|Reported Event|AZD0837 300 mg|AZD0837 300 mg
1031067|NCT00739973|E7|Reported Event|Aliskiren/Amlodipine 150/10 mg Tablet|150/5 for 1 week, then up-titrated to 150/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031068|NCT00739973|E6|Reported Event|Aliskiren/Amlodipine 150/5 mg Tablet|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031069|NCT00739973|E5|Reported Event|Amlodipine 10 mg Capsule|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos. Amlodipine 10 mg arm starts with 1 week of Amlodipine 5 mg, then force titrated to 10 mg.
1031070|NCT00739973|E4|Reported Event|Amlodipine 5 mg Capsule|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031071|NCT00739973|E3|Reported Event|Aliskiren 300 mg Tablet|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031072|NCT00739973|E2|Reported Event|Aliskiren 150 mg Tablet|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; 4 of the 5 pills taken were placebos.
1031073|NCT00739973|E1|Reported Event|Placebo|Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study; for this arm all the 5 pills taken were placebos.
1031074|NCT00739934|B1|Baseline|All Participants|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated). The oral maintenance dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
1031075|NCT00739934|P1|Participant Flow|All Participants|Voriconazole intravenous (IV) multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated). The oral maintenance dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
1031076|NCT00739934|O1|Outcome|Voriconazole Oral|Voriconazole oral dose (200 mg) was administered in the morning and evening following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
1031077|NCT00739934|O1|Outcome|Voriconazole Oral|Voriconazole oral dose (200 mg) was administered in the morning and evening following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
1031078|NCT00739934|O1|Outcome|Voriconazole Oral|Voriconazole oral dose (200 mg) was administered in the morning and evening following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
1031079|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated).
1031080|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated).
1031081|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated).
1031082|NCT00739934|O1|Outcome|All Treatments|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated). The oral maintenance dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
1031083|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Day 1.
1031084|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Day 1.
1031085|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Day 1.
1031086|NCT00739934|O1|Outcome|Voriconazole Oral|Voriconazole oral dose (200 mg) was administered in the morning and evening following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
1031087|NCT00739934|O1|Outcome|Voriconazole Oral|Voriconazole oral dose (200 mg) was administered in the morning and evening following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
1031088|NCT00739934|O1|Outcome|Voriconazole Oral|Voriconazole oral dose (200 mg) was administered in the morning and evening following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
1031089|NCT00739934|O1|Outcome|Voriconazole IV|Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 2 to 7 (up to Day 20 or more if clinically indicated).
1032204|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
1031101|NCT00739908|O2|Outcome|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
1031102|NCT00739908|O1|Outcome|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
1031103|NCT00739908|O2|Outcome|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
1031104|NCT00739908|O1|Outcome|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
1031105|NCT00739908|O2|Outcome|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
1031106|NCT00739908|O1|Outcome|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
1031107|NCT00739908|O2|Outcome|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
1031108|NCT00739908|O1|Outcome|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
1031109|NCT00739908|O2|Outcome|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
1031110|NCT00739908|O1|Outcome|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
1031111|NCT00739908|O2|Outcome|Oral Placebo TID|No active medication, the same as a Sugar Pill
1031112|NCT00739908|O1|Outcome|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational Reversible Monoamine Oxidase Inhibitor (MAOI)
1031113|NCT00739908|E2|Reported Event|Oral Placebo TID|Placebo does not have any active medication and is the same as a Sugar Pill.
1031114|NCT00739908|E1|Reported Event|Oral CX157 60 mg TID (Total Daily Dose of 180 mg)|CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
1031115|NCT00739882|B3|Baseline|Total|Total of all reporting groups
1031116|NCT00739882|B2|Baseline|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
1031117|NCT00739882|B1|Baseline|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
1031118|NCT00739882|P2|Participant Flow|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
1031119|NCT00739882|P1|Participant Flow|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
1031120|NCT00739882|O2|Outcome|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
1031121|NCT00739882|O1|Outcome|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
1031122|NCT00739882|O2|Outcome|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
1031123|NCT00739882|O1|Outcome|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
1031124|NCT00739882|O2|Outcome|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
1031148|NCT00739765|O1|Outcome|1 Interpersonal Psychotherapy (IPT)|"Participants will receive interpersonal psychotherapy.~Interpersonal Psychotherapy: 14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports"
1031125|NCT00739882|O1|Outcome|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
1031126|NCT00739882|O2|Outcome|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
1031127|NCT00739882|O1|Outcome|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
1031128|NCT00739882|O2|Outcome|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
1031129|NCT00739882|O1|Outcome|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
1031130|NCT00739882|O2|Outcome|Placebo|Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
1031131|NCT00739882|O1|Outcome|Efalizumab|Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.
1031132|NCT00739882|E4|Reported Event|Placebo - Open-label Period|
1031133|NCT00739882|E3|Reported Event|Efalizumab - Open-label Period|
1031134|NCT00739882|E2|Reported Event|Placebo - Double-blind Period|
1031135|NCT00739882|E1|Reported Event|Efalizumab - Double-blind Period|
1031136|NCT00739765|B4|Baseline|Total|Total of all reporting groups
1031137|NCT00739765|B3|Baseline|3 Relaxation Therapy|"Participants will receive relaxation therapy.~Relaxation Therapy: Nine 90-minute sessions and one 30-minute session, distributed over 14 weeks, that focus on muscle relaxation to address the physical symptoms of PTSD"
1031138|NCT00739765|B2|Baseline|2 Prolonged Exposure (PE)|"Participants will receive prolonged exposure therapy.~Prolonged Exposure Therapy: Ten 90-minute sessions, distributed over 14 weeks, of prolonged exposure, which involves the repeated, detailed recounting of the trauma to develop a coherent narrative and repeated exposure to reminders of the trauma"
1031139|NCT00739765|B1|Baseline|1 Interpersonal Psychotherapy (IPT)|"Participants will receive interpersonal psychotherapy.~Interpersonal Psychotherapy: 14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports"
1031140|NCT00739765|P3|Participant Flow|3 Relaxation Therapy|"Participants will receive relaxation therapy.~Relaxation Therapy: Nine 90-minute sessions and one 30-minute session, distributed over 14 weeks, that focus on muscle relaxation to address the physical symptoms of PTSD"
1031141|NCT00739765|P2|Participant Flow|2 Prolonged Exposure (PE)|"Participants will receive prolonged exposure therapy.~Prolonged Exposure Therapy: Ten 90-minute sessions, distributed over 14 weeks, of prolonged exposure, which involves the repeated, detailed recounting of the trauma to develop a coherent narrative and repeated exposure to reminders of the trauma"
1031142|NCT00739765|P1|Participant Flow|1 Interpersonal Psychotherapy (IPT)|"Participants will receive interpersonal psychotherapy.~Interpersonal Psychotherapy: 14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports"
1031143|NCT00739765|O3|Outcome|3 Relaxation Therapy|"Participants will receive relaxation therapy.~Relaxation Therapy: Nine 90-minute sessions and one 30-minute session, distributed over 14 weeks, that focus on muscle relaxation to address the physical symptoms of PTSD"
1031144|NCT00739765|O2|Outcome|2 Prolonged Exposure (PE)|"Participants will receive prolonged exposure therapy.~Prolonged Exposure Therapy: Ten 90-minute sessions, distributed over 14 weeks, of prolonged exposure, which involves the repeated, detailed recounting of the trauma to develop a coherent narrative and repeated exposure to reminders of the trauma"
1031145|NCT00739765|O1|Outcome|1 Interpersonal Psychotherapy (IPT)|"Participants will receive interpersonal psychotherapy.~Interpersonal Psychotherapy: 14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports"
1031146|NCT00739765|O3|Outcome|3 Relaxation Therapy|"Participants will receive relaxation therapy.~Relaxation Therapy: Nine 90-minute sessions and one 30-minute session, distributed over 14 weeks, that focus on muscle relaxation to address the physical symptoms of PTSD"
1031147|NCT00739765|O2|Outcome|2 Prolonged Exposure (PE)|"Participants will receive prolonged exposure therapy.~Prolonged Exposure Therapy: Ten 90-minute sessions, distributed over 14 weeks, of prolonged exposure, which involves the repeated, detailed recounting of the trauma to develop a coherent narrative and repeated exposure to reminders of the trauma"
1031209|NCT00739596|B3|Baseline|Total|Total of all reporting groups
1032205|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
1031149|NCT00739765|E3|Reported Event|3 Relaxation Therapy|"Participants will receive relaxation therapy.~Relaxation Therapy: Nine 90-minute sessions and one 30-minute session, distributed over 14 weeks, that focus on muscle relaxation to address the physical symptoms of PTSD"
1031150|NCT00739765|E2|Reported Event|2 Prolonged Exposure (PE)|"Participants will receive prolonged exposure therapy.~Prolonged Exposure Therapy: Ten 90-minute sessions, distributed over 14 weeks, of prolonged exposure, which involves the repeated, detailed recounting of the trauma to develop a coherent narrative and repeated exposure to reminders of the trauma"
1031151|NCT00739765|E1|Reported Event|1 Interpersonal Psychotherapy (IPT)|"Participants will receive interpersonal psychotherapy.~Interpersonal Psychotherapy: 14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports"
1031152|NCT00739674|B3|Baseline|Total|Total of all reporting groups
1031153|NCT00739674|B2|Baseline|Diet Management and Losartan-Based Regimen (DML Group)|"Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.~The Baseline Measures are reported for the Intent-to-treat (ITT) population (i.e. took at least one dose of the study medication and returned for one follow-up visit)."
1031154|NCT00739674|B1|Baseline|Losartan-Based Regimen Alone (L Group)|"Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.~The Baseline Measures are reported for the Intent-to-treat (ITT) population (i.e. took at least one dose of the study medication and returned for one follow-up visit)."
1031155|NCT00739674|P2|Participant Flow|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt Dietary Approaches to Stop Hypertension (DASH) diet management.
1031156|NCT00739674|P1|Participant Flow|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including hydrochlorothiazide (HCTZ) 12.5 mg or 25 mg and calcium channel blocker (CCB) as needed to achieve target blood pressure.
1031157|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
1031158|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
1031159|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
1031160|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
1031161|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
1031162|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
1031163|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
1031164|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
1031165|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
1031166|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
1031167|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
1031168|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
1031169|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
1031170|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
1031171|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
1031172|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
1031173|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
1031174|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
1031175|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
1031515|NCT00738426|E2|Reported Event|Sham Device|"non-therapeutic sham light output~Sham device: non-therapeutic light energy output"
1031176|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
1031177|NCT00739674|O2|Outcome|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
1031178|NCT00739674|O1|Outcome|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
1031179|NCT00739674|E2|Reported Event|Diet Management and Losartan-Based Regimen (DML Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.
1031180|NCT00739674|E1|Reported Event|Losartan-Based Regimen Alone (L Group)|Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
1031181|NCT00739661|B3|Baseline|Total|Total of all reporting groups
1031182|NCT00739661|B2|Baseline|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
1031183|NCT00739661|B1|Baseline|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
1031184|NCT00739661|P2|Participant Flow|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
1031185|NCT00739661|P1|Participant Flow|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
1031186|NCT00739661|O2|Outcome|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
1031187|NCT00739661|O1|Outcome|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
1031188|NCT00739661|O2|Outcome|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
1031189|NCT00739661|O1|Outcome|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
1031190|NCT00739661|O2|Outcome|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
1031191|NCT00739661|O1|Outcome|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
1031192|NCT00739661|E2|Reported Event|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
1031193|NCT00739661|E1|Reported Event|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily until radiographically confirmed disease progression, intolerable toxicity, or withdrawal from the study.
1031194|NCT00739648|B3|Baseline|Total|Total of all reporting groups
1031195|NCT00739648|B2|Baseline|MP-376 240 mg BID|MP-376 240 mg inhaled twice daily via the PARI eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
1031196|NCT00739648|B1|Baseline|Placebo|Placebo inhaled twice daily via the eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
1031197|NCT00739648|P2|Participant Flow|MP-376 240 mg BID|MP-376 240 mg inhaled twice daily via the PARI eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
1031198|NCT00739648|P1|Participant Flow|Placebo|Placebo inhaled twice daily via the eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
1031199|NCT00739648|O2|Outcome|MP-376 240 mg BID|MP-376 240 mg inhaled BID via nebulization for 5 consecutive days in a 28-day cycle for up to 12 cycles
1031200|NCT00739648|O1|Outcome|Placebo|Placebo inhaled BID via nebulization for 5 consecutive days in a 28-day cycle for up to 12 cycles
1031201|NCT00739648|O2|Outcome|MP-376 240 mg BID|MP-376 240 mg inhaled BID via nebulization for 5 consecutive days in a 28-day cycle for up to 12 cycles
1031202|NCT00739648|O1|Outcome|Placebo|Placebo inhaled BID via nebulization for 5 consecutive days in a 28-day cycle for up to 12 cycles
1031203|NCT00739648|O2|Outcome|MP-376 240 mg BID|MP-376 240 mg inhaled BID via nebulization for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
1031204|NCT00739648|O1|Outcome|Placebo|Placebo inhaled BID via nebulization for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
1031205|NCT00739648|O2|Outcome|MP-376 240 mg BID|MP-376 240 mg inhaled twice daily (BID)via PARI eFlow nebulizer for 5 consecutive days in each 28-day treatment cycle for up to 12 cycles
1031206|NCT00739648|O1|Outcome|Placebo|Placebo inhaled twice daily (BID) via PARI eFlow nebulizer for 5 consecutive days in each 28-day treatment cycle for up to 12 cycles
1031207|NCT00739648|E2|Reported Event|MP-376 240 mg BID|MP-376 240 mg inhaled twice daily via the PARI eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
1031208|NCT00739648|E1|Reported Event|Placebo|Placebo inhaled twice daily via the eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles
1031212|NCT00739596|P2|Participant Flow|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks
1031213|NCT00739596|P1|Participant Flow|Aliskiren Hydrochlorothiazide (HCTZ)|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
1031214|NCT00739596|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks
1075910|NCT00623779|E1|Reported Event|AZD0837 150 mg|AZD0837 150 mg
1031215|NCT00739596|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
1031216|NCT00739596|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks
1031217|NCT00739596|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
1031218|NCT00739596|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks
1031219|NCT00739596|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
1031220|NCT00739596|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks
1031221|NCT00739596|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
1031222|NCT00739596|O2|Outcome|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks
1031223|NCT00739596|O1|Outcome|Aliskiren HCTZ|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks
1031224|NCT00739596|E2|Reported Event|Amlodipine|Amlodipine 5 mg for 1 week followed by forced titration to Amlodipine 10 mg for remaining 7 weeks.
1031225|NCT00739596|E1|Reported Event|Aliskiren HCTZ|Aliskiren HCTZ (150/12.5 mg) for 1 week followed by forced titration to Aliskiren HCTZ (300/25 mg) for remaining 7 weeks.
1031226|NCT00739583|B3|Baseline|Total|Total of all reporting groups
1031227|NCT00739583|B2|Baseline|Iodine Group|Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
1031228|NCT00739583|B1|Baseline|Chlorhexidine Group|Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
1031229|NCT00739583|P2|Participant Flow|Iodine Group|Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
1031230|NCT00739583|P1|Participant Flow|Chlorhexidine Group|Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
1031231|NCT00739583|O2|Outcome|Iodine Group|Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
1031232|NCT00739583|O1|Outcome|Chlorhexidine Group|Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
1031233|NCT00739583|O2|Outcome|Iodine Group|Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
1031234|NCT00739583|O1|Outcome|Chlorhexidine Group|Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
1031235|NCT00739583|O2|Outcome|Iodine Group|Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
1031236|NCT00739583|O1|Outcome|Chlorhexidine Group|Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
1031237|NCT00739583|E2|Reported Event|Iodine Group|Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
1031238|NCT00739583|E1|Reported Event|Chlorhexidine Group|Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
1031239|NCT00739336|B3|Baseline|Total|Total of all reporting groups
1031240|NCT00739336|B2|Baseline|Control|"This is a wait control group, This group will begin the program (described in A,1) after 3 months."
1031241|NCT00739336|B1|Baseline|Intervention|"A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.~Diabetes Prevention and Control: The program will be delivered over 3 months in 12 one hour weekly mid-day sessions at the worksite. The curriculum has been adapted from the Diabetes Prevention Program, the National Diabetes Education Program and Conversation maps from Healthy Interactions Inc. Topics relate to healthy eating, physical activity, coping with disease and depression, and cardiovascular disease prevention. Additional topics may be included per feedback and need of the participants. After completion of the 3 month program, there will be monthly meetings."
1031242|NCT00739336|P2|Participant Flow|Control|"This is a wait control group, This group will begin the program (described in A,1) after 3 months."
1031243|NCT00739336|P1|Participant Flow|Intervention|A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.
1031244|NCT00739336|O2|Outcome|Control|"This is a wait control group, This group will begin the program (described in A,1) after 3 months."
1031245|NCT00739336|O1|Outcome|Intervention|A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.
1031246|NCT00739336|O2|Outcome|Control|"This is a wait control group, This group will begin the program (described in A,1) after 3 months."
1031247|NCT00739336|O1|Outcome|Intervention|A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.
1031248|NCT00739336|O2|Outcome|Control|"This is a wait control group, This group will begin the program (described in A,1) after 3 months."
1031249|NCT00739336|O1|Outcome|Intervention|A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.
1031250|NCT00739336|O2|Outcome|Control|"This is a wait control group, This group will begin the program (described in A,1) after 3 months."
1031516|NCT00738426|E1|Reported Event|Erchonia ML Scanner (MLS)|"red diode low level laser light energy~Erchonia ML Scanner (MLS): Red diode low level laser light energy."
1031251|NCT00739336|O1|Outcome|Intervention|A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.
1031252|NCT00739336|E2|Reported Event|Control|"This is a wait control group, This group will begin the program (described in A,1) after 3 months."
1031253|NCT00739336|E1|Reported Event|Intervention|A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.
1031254|NCT00739310|B1|Baseline|Vest Treatment (HFCWO)|"Patients will receive Vest treatments for airway clearance therapy 2 x daily for 12 months. These data will be compared to 12 months of data prior to Vest initiation.~Vest Treatment (high frequency chest wall oscillation): twice daily for 15-20 minutes"
1031255|NCT00739310|P1|Participant Flow|Vest Treatment (HFCWO)|"Patients will receive Vest treatments for airway clearance therapy 2 x daily~Vest Treatment (high frequency chest wall oscillation): twice daily for 15-20 minutes"
1031256|NCT00739310|O2|Outcome|Post Vest Treatment|12 months of intervention 2 x daily Vest Therapy
1031257|NCT00739310|O1|Outcome|Pre-Treatment|Prior to Vest Treatment
1031258|NCT00739310|E1|Reported Event|Vest Treatment (HFCWO)|"Patients will receive Vest treatments for airway clearance therapy 2 x daily~Vest Treatment (high frequency chest wall oscillation): twice daily for 15-20 minutes"
1031259|NCT00739297|B1|Baseline|All Participants|Combined participants from all arms.
1031260|NCT00739297|P7|Participant Flow|Total|"Consistent with the incomplete-block design of this study, 6 treatments (placebo and 5 active-dose levels) were administered during only 4 treatment periods. In other words, in this 4-period crossover design, no patient received all 6 treatments and thus some treatments were not~received by all of the patients. Therefore, the TOTAL number of participants across ALL the dose levels provides the best metric to follow the consistency of patient flow from one treatment period to the next treatment period."
1031261|NCT00739297|P6|Participant Flow|1000 mcg Montelukast|Patients are randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
1031262|NCT00739297|P5|Participant Flow|500 mcg Montelukast|Patients are randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
1031263|NCT00739297|P4|Participant Flow|250 mcg Montelukast|Patients are randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
1031264|NCT00739297|P3|Participant Flow|100 mcg Montelukast|Patients are randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
1031265|NCT00739297|P2|Participant Flow|25 mcg Montelukast|Patients are randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
1031266|NCT00739297|P1|Participant Flow|Placebo|Patients are randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol is administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
1031267|NCT00739297|O6|Outcome|1000 mcg Montelukast|Patients are randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
1031268|NCT00739297|O5|Outcome|500 mcg Montelukast|Patients are randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
1031269|NCT00739297|O4|Outcome|250 mcg Montelukast|Patients are randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
1031306|NCT00738062|O2|Outcome|Placebo|"Placebo~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1031308|NCT00738062|O2|Outcome|Placebo|"Placebo~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1031517|NCT00738400|B3|Baseline|Total|Total of all reporting groups
1075911|NCT00623766|B3|Baseline|Total|Total of all reporting groups
1031270|NCT00739297|O3|Outcome|100 mcg Montelukast|Patients are randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
1031271|NCT00739297|O2|Outcome|25 mcg Montelukast|Patients are randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
1031272|NCT00739297|O1|Outcome|Placebo|Patients are randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol is administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
1031273|NCT00739297|O6|Outcome|1000 mcg Montelukast|Patients are randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
1031274|NCT00739297|O5|Outcome|500 mcg Montelukast|Patients are randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
1031275|NCT00739297|O4|Outcome|250 mcg Montelukast|Patients are randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
1031276|NCT00739297|O3|Outcome|100 mcg Montelukast|Patients are randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
1031277|NCT00739297|O2|Outcome|25 mcg Montelukast|Patients are randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
1031278|NCT00739297|O1|Outcome|Placebo|Patients are randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol is administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
1031279|NCT00739297|O2|Outcome|Montelukast+ Placebo|Montelukast (data for each patient are pooled across all 3 of the active doses received by that patient) +Placebo for Albuterol (data for each patient are pooled across all 3 administrations of placebo for albuterol, as added to active montelukast)
1031280|NCT00739297|O1|Outcome|Montelukast+Albuterol|Montelukast (data for each patient are pooled across all 3 of the active doses received by that patient) +Albuterol (data for each patient are pooled across all 3 administrations of active albuterol, as added to active montelukast)
1031281|NCT00739297|O6|Outcome|1000 mcg Montelukast|Patients are randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
1031282|NCT00739297|O5|Outcome|500 mcg Montelukast|Patients are randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
1031283|NCT00739297|O4|Outcome|250 mcg Montelukast|Patients are randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
1031284|NCT00739297|O3|Outcome|100 mcg Montelukast|Patients are randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
1031307|NCT00738062|O1|Outcome|Droxidopa|"Study medication~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1031513|NCT00738426|O2|Outcome|Sham Device|"non-therapeutic sham light output~Sham device: non-therapeutic light energy output"
1031285|NCT00739297|O2|Outcome|25 mcg Montelukast|Patients are randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
1031286|NCT00739297|O1|Outcome|Placebo|Patients are randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol is administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
1031287|NCT00739297|E6|Reported Event|1000 mcg Montelukast|Patients are randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
1031288|NCT00739297|E5|Reported Event|500 mcg Montelukast|Patients are randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
1031289|NCT00739297|E4|Reported Event|250 mcg Montelukast|Patients are randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
1031290|NCT00739297|E3|Reported Event|100 mcg Montelukast|Patients are randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
1031291|NCT00739297|E2|Reported Event|25 mcg Montelukast|Patients are randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
1031292|NCT00739297|E1|Reported Event|Placebo|Patients are randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol is administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
1031293|NCT00738062|B4|Baseline|Total|Total of all reporting groups
1031294|NCT00738062|B3|Baseline|Double-blind Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1031295|NCT00738062|B2|Baseline|Double-blind Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1031296|NCT00738062|B1|Baseline|Open-Label Droxidopa|Only participated in 3 months of open-label treatment with droxidopa (t.i.d., at optimal dose)
1031297|NCT00738062|P3|Participant Flow|Double-blind Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1031298|NCT00738062|P2|Participant Flow|Double-blind Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1031299|NCT00738062|P1|Participant Flow|Open-Label Droxidopa|3 months of open-label treatment with droxidopa (t.i.d., at optimal dose)
1031300|NCT00738062|O2|Outcome|Placebo|"Placebo~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1031301|NCT00738062|O1|Outcome|Droxidopa|"Study medication~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1031302|NCT00738062|O2|Outcome|Placebo|"Placebo~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1031303|NCT00738062|O1|Outcome|Droxidopa|"Study medication~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1031304|NCT00738062|O2|Outcome|Placebo|"Placebo~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1031305|NCT00738062|O1|Outcome|Droxidopa|"Study medication~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1031405|NCT00738972|E3|Reported Event|Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C)
1031309|NCT00738062|O1|Outcome|Droxidopa|"Study medication~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1031310|NCT00738062|O2|Outcome|Placebo|"Placebo~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1031311|NCT00738062|O1|Outcome|Droxidopa|"Study medication~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1031312|NCT00738062|O2|Outcome|Placebo|"Placebo~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1031313|NCT00738062|O1|Outcome|Droxidopa|"Study medication~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1031314|NCT00738062|O2|Outcome|Placebo|"Placebo~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1031315|NCT00738062|O1|Outcome|Droxidopa|"Study medication~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1031316|NCT00738062|O2|Outcome|Placebo|"Placebo~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1031317|NCT00738062|O1|Outcome|Droxidopa|"Study medication~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1031318|NCT00738062|E5|Reported Event|Total Droxidopa|All Patients exposed to droxidopa
1031319|NCT00738062|E4|Reported Event|Long-Term Follow-up|Open-label treatment with droxidopa (t.i.d) following the double-blind randomization phase.
1031320|NCT00738062|E3|Reported Event|Double-blind Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1031321|NCT00738062|E2|Reported Event|Double-blind Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1031322|NCT00738062|E1|Reported Event|Three Month Open-Label Droxidopa|all patients who participated in 3 months of open-label treatment with droxidopa (t.i.d., at optimal dose)
1031323|NCT00738049|B3|Baseline|Total|Total of all reporting groups
1031324|NCT00738049|B2|Baseline|Group 2|Group 2 received placebo during Phase 1 then oral Darusentan 100 mg during Phase 2.
1031325|NCT00738049|B1|Baseline|Group 1|Group 1 received oral Darusentan 100mg during Phase 1 then placebo during Phase 2.
1031326|NCT00738049|P2|Participant Flow|Placebo, Then Darusentan 100mg|Patients were randomized to oral placebo for 14 days, then underwent PET imaging. Study patients then received Darusentan 100mg for 14 days. The patients underwent cardiac PET imaging followed by a 14 day washout period and final PET scan. Patients and physicians were blinded to medication assignment.
1031327|NCT00738049|P1|Participant Flow|Darusentan Then Placebo,|Patients were randomized to oral Darusentan 100mg for 14 days and then underwent cardiac PET imaging. They then received placebo for 14 days and underwent PET imaging, followed by a washout period of 14 days and completed the final cardiac PET scan. Patients and physicians were blinded to medication assignment.
1031328|NCT00738049|O2|Outcome|Darusentan 100mg|All patients underwent a assessment of CFR while receiving darusentan
1031329|NCT00738049|O1|Outcome|Baseline|All patients underwent a baseline assessment of CFR before receiving darusentan or placebo
1031330|NCT00738049|O4|Outcome|Baseline at Hyperemia|All patients underwent a baseline assessment of hyperemic flow before receiving darusentan or placebo
1031331|NCT00738049|O3|Outcome|Baseline at Rest|All patients underwent a baseline assessment of resting flow before receiving darusentan or placebo
1031332|NCT00738049|O2|Outcome|Darusentan 100mg at Hyperemia|All patients underwent assessment of hyperemic flow while receiving darusentan
1031333|NCT00738049|O1|Outcome|Darusentan 100mg at Rest|All patients underwent assessment of rest flow while receiving darusentan
1031334|NCT00738049|O2|Outcome|Darusentan 100mg|All patients underwent a baseline assessment of Markovian homogeneity while taking darusentan
1031335|NCT00738049|O1|Outcome|Baseline|All patients underwent a baseline assessment of Markovian homogeneity before receiving darusentan or placebo
1031336|NCT00738049|E2|Reported Event|Group 2|Received placebo during Phase 1, Darusentan 100mg during Phase 2
1031337|NCT00738049|E1|Reported Event|Group 1|Darusentan 100mg during Phase 1, Placebo during Phase 2
1031338|NCT00738023|B3|Baseline|Total|Total of all reporting groups
1031339|NCT00738023|B2|Baseline|Non-Diabetic|Obese, normotensive African-Americans without diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours and normal saline 0.9% at 40 ml/hr intravenously for 48 hours
1031340|NCT00738023|B1|Baseline|Diabetics|Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and rosiglitazone for 6 weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours
1031341|NCT00738023|P2|Participant Flow|Non-Diabetic|Obese, normotensive African-Americans without diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours
1031406|NCT00738972|E2|Reported Event|Valsartan 80 mg + Simvastatin 40 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B)
1034375|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
1031409|NCT00738881|B2|Baseline|Arm II|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pemetrexed disodium: Given IV"
1031342|NCT00738023|P1|Participant Flow|Diabetics|Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and rosiglitazone for six weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours
1031343|NCT00738023|O1|Outcome|Diabetics|"Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, then normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and then randomized to rosiglitazone for six weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours~Rosiglitazone: Diabetic subjects will be receive rosiglitazone for 6 weeks~Normal saline 0.9%: Normal saline 0.9% intravenous infusion at 40ml/hr for 48 hours~Intralipid 20%: Intralipid 20% at 40ml/hr intravenously for 48 hours"
1031344|NCT00738023|O1|Outcome|Diabetics|"Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, then normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and then randomized to rosiglitazone for six weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours~Rosiglitazone: Diabetic subjects will be receive rosiglitazone for 6 weeks~Normal saline 0.9%: Normal saline 0.9% intravenous infusion at 40ml/hr for 48 hours~Intralipid 20%: Intralipid 20% at 40ml/hr intravenously for 48 hours"
1031345|NCT00738023|O2|Outcome|Non-Diabetic|Obese, normotensive African-Americans without diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours and normal saline 0.9% at 40 ml/hr intravenously for 48 hours
1031346|NCT00738023|O1|Outcome|Diabetics|Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and rosiglitazone for 6 weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours
1031347|NCT00738023|E2|Reported Event|Non-Diabetic|Obese, normotensive African-Americans without diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours
1031348|NCT00738023|E1|Reported Event|Diabetics|Obese, normotensive African-Americans with diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours, normal saline 0.9% at 40 ml/hr intravenously for 48 hours, and rosiglitazone for six weeks followed by Intralipid 20% at 40ml/hr intravenously for 48 hours
1031349|NCT00739102|B1|Baseline|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
1031350|NCT00739102|P1|Participant Flow|S.M.A.R.T.® Nitinol Stent System|The Cordis S.M.A.R.T. ®Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
1031351|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
1031352|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
1031353|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
1031354|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
1031355|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
1031356|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
1031357|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
1031358|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
1031359|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
1031407|NCT00738972|E1|Reported Event|Valsartan 80 mg + Paravastin 40 mg|Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A)
1031408|NCT00738881|B3|Baseline|Total|Total of all reporting groups
1031360|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
1031361|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
1031362|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
1031363|NCT00739102|O1|Outcome|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
1031364|NCT00739102|E1|Reported Event|S.M.A.R.T.™ Nitinol Stent System|The Cordis S.M.A.R.T.™ Nitinol Stent System is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
1031365|NCT00739063|B1|Baseline|Tarceva Daily|Tarceva oral 150 mg daily.
1031366|NCT00739063|P1|Participant Flow|Tarceva Daily|Tarceva oral 150 mg daily.
1031367|NCT00739063|O1|Outcome|Tarceva Daily|Tarceva oral 150 mg daily.
1031368|NCT00739063|E1|Reported Event|Tarceva Daily|Tarceva oral 150 mg daily.
1031369|NCT00739050|B1|Baseline|All Participants|"All Randomized patients.~Laboratory values were only avaliable for 3 participants for Total Cholesterol, Low Density Lipoprotein Cholesterol (LDL-C), and High Density Lipoprotein Cholesterol (HDL-C)"
1031370|NCT00739050|P2|Participant Flow|Placebo|Placebo daily at nights for 12 weeks
1031371|NCT00739050|P1|Participant Flow|Simvastatin|simvastatin 20 mg daily at nights for 12 weeks
1031372|NCT00739050|O2|Outcome|Placebo|Placebo daily at nights for 12 weeks
1031373|NCT00739050|O1|Outcome|Simvastatin|simvastatin 20 mg daily at nights for 12 weeks
1031374|NCT00739050|O2|Outcome|Placebo|Placebo daily at nights for 12 weeks
1031375|NCT00739050|O1|Outcome|Simvastatin|simvastatin 20 mg daily at nights for 12 weeks
1031376|NCT00739050|O2|Outcome|Placebo|Placebo daily at nights for 12 weeks
1031377|NCT00739050|O1|Outcome|Simvastatin|simvastatin 20 mg daily at nights for 12 weeks
1031378|NCT00739050|O2|Outcome|Placebo|Placebo daily at nights for 12 weeks
1031379|NCT00739050|O1|Outcome|Simvastatin|simvastatin 20 mg daily at nights for 12 weeks
1031380|NCT00739050|E2|Reported Event|Placebo|Placebo daily at nights for 12 weeks
1031381|NCT00739050|E1|Reported Event|Simvastatin|simvastatin 20 mg daily at nights for 12 weeks
1031382|NCT00739024|B3|Baseline|Total|Total of all reporting groups
1031383|NCT00739024|B2|Baseline|Placebo|Random assignment to placebo
1031384|NCT00739024|B1|Baseline|Active Treatment|Random assignment to active treatment
1031385|NCT00739024|P2|Participant Flow|Placebo|Random assignment to placebo
1031386|NCT00739024|P1|Participant Flow|Active Treatment|Random assignment to active treatment
1031387|NCT00739024|O2|Outcome|Placebo|Random assignment to placebo
1031388|NCT00739024|O1|Outcome|Active Treatment|Random assignment to active treatment
1031389|NCT00739024|E2|Reported Event|Placebo|Random assignment to placebo
1031390|NCT00739024|E1|Reported Event|Active Treatment|Random assignment to active treatment
1031391|NCT00738972|B5|Baseline|Total|Total of all reporting groups
1031392|NCT00738972|B4|Baseline|Valsartan 80 mg|Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D)
1031393|NCT00738972|B3|Baseline|Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C)
1031394|NCT00738972|B2|Baseline|Valsartan 80 mg + Simvastatin 40 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B)
1031395|NCT00738972|B1|Baseline|Valsartan 80 mg + Paravastin 40 mg|Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A)
1031396|NCT00738972|P4|Participant Flow|Valsartan 80 mg|Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D)
1031397|NCT00738972|P3|Participant Flow|Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C)
1031398|NCT00738972|P2|Participant Flow|Valsartan 80 mg + Simvastatin 40 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B)
1031399|NCT00738972|P1|Participant Flow|Valsartan 80 mg + Paravastin 40 mg|Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A)
1031400|NCT00738972|O4|Outcome|Valsartan 80 mg|Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D)
1031401|NCT00738972|O3|Outcome|Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C)
1031402|NCT00738972|O2|Outcome|Valsartan 80 mg + Simvastatin 40 mg|Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B)
1031403|NCT00738972|O1|Outcome|Valsartan 80 mg + Paravastin 40 mg|Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A)
1031404|NCT00738972|E4|Reported Event|Valsartan 80 mg|Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D)
1031410|NCT00738881|B1|Baseline|Arm I|"Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally"
1031411|NCT00738881|P2|Participant Flow|Arm II|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pemetrexed disodium: Given IV"
1031412|NCT00738881|P1|Participant Flow|Arm I|"Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally"
1031413|NCT00738881|O2|Outcome|Arm II|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pemetrexed disodium: Given IV"
1031414|NCT00738881|O1|Outcome|Arm I|"Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally"
1031415|NCT00738881|O2|Outcome|Arm II|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pemetrexed disodium: Given IV"
1031416|NCT00738881|O1|Outcome|Arm I|"Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally"
1031417|NCT00738881|O2|Outcome|Arm II|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pemetrexed disodium: Given IV"
1031418|NCT00738881|O1|Outcome|Arm I|"Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally"
1031419|NCT00738881|O2|Outcome|Arm II|"Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pemetrexed disodium: Given IV"
1031420|NCT00738881|O1|Outcome|Arm I|"Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given orally"
1031421|NCT00738881|E2|Reported Event|Arm II|pemetrexed disodium: Given IV
1031422|NCT00738881|E1|Reported Event|Arm I|erlotinib hydrochloride: Given orally
1031423|NCT00738699|B3|Baseline|Total|Total of all reporting groups
1031424|NCT00738699|B2|Baseline|Placebo (Normal Saline) Plus Paclitaxel|An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
1031425|NCT00738699|B1|Baseline|MORAb-003 (Farletuzumab) Plus Paclitaxel|Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
1031426|NCT00738699|P2|Participant Flow|Placebo (Normal Saline) Plus Paclitaxel|An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
1031427|NCT00738699|P1|Participant Flow|MORAb-003 (Farletuzumab) Plus Paclitaxel|Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
1031428|NCT00738699|O2|Outcome|Placebo (Normal Saline) Plus Paclitaxel|An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
1031459|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
1031512|NCT00738426|P1|Participant Flow|Erchonia ML Scanner (MLS)|"red diode low level laser light energy~Erchonia ML Scanner (MLS): Red diode low level laser light energy."
1034376|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
1031514|NCT00738426|O1|Outcome|Erchonia ML Scanner (MLS)|"Red diode low level laser light energy~Erchonia ML Scanner (MLS): Red diode low level laser light energy."
1075968|NCT00623636|B3|Baseline|Total|Total of all reporting groups
1031429|NCT00738699|O1|Outcome|MORAb-003 (Farletuzumab) Plus Paclitaxel|Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
1031430|NCT00738699|O2|Outcome|Placebo (Normal Saline) Plus Paclitaxel|An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
1031431|NCT00738699|O1|Outcome|MORAb-003 (Farletuzumab) Plus Paclitaxel|Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
1031432|NCT00738699|O2|Outcome|Placebo (Normal Saline) Plus Paclitaxel|An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
1031433|NCT00738699|O1|Outcome|MORAb-003 (Farletuzumab) Plus Paclitaxel|Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
1031434|NCT00738699|O2|Outcome|Placebo (Normal Saline) Plus Paclitaxel|An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
1031435|NCT00738699|O1|Outcome|MORAb-003 (Farletuzumab) Plus Paclitaxel|Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
1031436|NCT00738699|O2|Outcome|Placebo (Normal Saline) Plus Paclitaxel|An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
1031437|NCT00738699|O1|Outcome|MORAb-003 (Farletuzumab) Plus Paclitaxel|Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
1031438|NCT00738699|O2|Outcome|Placebo (Normal Saline) Plus Paclitaxel|An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
1031508|NCT00738426|B3|Baseline|Total|Total of all reporting groups
1031509|NCT00738426|B2|Baseline|Sham Device|"non-therapeutic sham light output~Sham device: non-therapeutic light energy output"
1031439|NCT00738699|O1|Outcome|MORAb-003 (Farletuzumab) Plus Paclitaxel|Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
1031440|NCT00738699|E2|Reported Event|Placebo (Normal Saline) Plus Paclitaxel|An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
1031441|NCT00738699|E1|Reported Event|MORAb-003 (Farletuzumab) Plus Paclitaxel|Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion.
1031442|NCT00738673|B3|Baseline|Total|Total of all reporting groups
1031443|NCT00738673|B2|Baseline|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
1031444|NCT00738673|B1|Baseline|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
1031445|NCT00738673|P2|Participant Flow|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
1031446|NCT00738673|P1|Participant Flow|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
1031447|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
1031448|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
1031449|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
1031450|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
1031451|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
1031452|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
1031453|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
1031454|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
1031455|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
1031456|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
1031457|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
1031458|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
1032206|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
1031460|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
1031461|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
1031462|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
1031463|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
1031464|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
1031465|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
1031466|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
1031467|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
1031468|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
1031469|NCT00738673|O2|Outcome|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
1031470|NCT00738673|O1|Outcome|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
1031471|NCT00738673|E2|Reported Event|Degarelix - Cohort 2|Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
1031472|NCT00738673|E1|Reported Event|Degarelix - Cohort 1|Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
1031473|NCT00738543|B1|Baseline|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
1031474|NCT00738543|P1|Participant Flow|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
1031475|NCT00738543|O1|Outcome|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
1031476|NCT00738543|O1|Outcome|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
1031477|NCT00738543|O1|Outcome|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
1031478|NCT00738543|O1|Outcome|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
1031479|NCT00738543|O1|Outcome|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
1031480|NCT00738543|E1|Reported Event|Whole Group|Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
1031481|NCT00738530|B3|Baseline|Total|Total of all reporting groups
1031482|NCT00738530|B2|Baseline|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
1031483|NCT00738530|B1|Baseline|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
1031484|NCT00738530|P2|Participant Flow|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every 2 weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
1031485|NCT00738530|P1|Participant Flow|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every 2 weeks at a dose of 10 milligram per kilogram (mg/kg) for 52 weeks or until disease progression or unacceptable toxicity. Interferon alfa-2a (IFN-Alfa-2A) was administered 3 times per week as a subcutaneous injection at a dose of 9 million international units (MIU) for 52 weeks or until disease progression or major toxicity.
1031486|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
1031510|NCT00738426|B1|Baseline|Erchonia ML Scanner (MLS)|"Red diode low level laser light energy~Erchonia ML Scanner (MLS): Red diode low level laser light energy."
1034377|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
1031487|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
1031488|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
1031489|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
1031490|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
1031491|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
1031492|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
1031493|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
1031494|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
1031495|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
1031496|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
1031497|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
1031498|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
1031499|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
1031500|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
1031501|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
1031502|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
1031503|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
1031504|NCT00738530|O2|Outcome|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
1031505|NCT00738530|O1|Outcome|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
1031506|NCT00738530|E2|Reported Event|Placebo + IFN-Alfa-2A|Placebo matched with Bevacizumab infusions were administered every two weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
1031507|NCT00738530|E1|Reported Event|Bevacizumab + IFN-Alfa-2A|Bevacizumab infusions were administered every two weeks at a dose of 10 mg/kg for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A was administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.
1031518|NCT00738400|B2|Baseline|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
1031519|NCT00738400|B1|Baseline|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
1031520|NCT00738400|P2|Participant Flow|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
1031521|NCT00738400|P1|Participant Flow|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
1031522|NCT00738400|O2|Outcome|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
1031523|NCT00738400|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
1031524|NCT00738400|O2|Outcome|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
1031525|NCT00738400|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
1031526|NCT00738400|O2|Outcome|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
1031527|NCT00738400|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
1031528|NCT00738400|O2|Outcome|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
1031529|NCT00738400|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
1031530|NCT00738400|O2|Outcome|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
1031531|NCT00738400|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
1031532|NCT00738400|O2|Outcome|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
1031533|NCT00738400|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
1031534|NCT00738400|O2|Outcome|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
1031535|NCT00738400|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
1031536|NCT00738400|E2|Reported Event|Placebo|Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
1031537|NCT00738400|E1|Reported Event|Vardenafil (Levitra, BAY38-9456)|Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
1031538|NCT00738374|B4|Baseline|Total|Total of all reporting groups
1031539|NCT00738374|B3|Baseline|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
1031540|NCT00738374|B2|Baseline|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
1031541|NCT00738374|B1|Baseline|CLB + R: Not Randomized|Participants began a 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants who completed the induction treatment with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, every 8 weeks for up to 24 months, or to be observed for up to 24 months with no further treatment.
1031542|NCT00738374|P4|Participant Flow|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
1031543|NCT00738374|P3|Participant Flow|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
1031686|NCT00737594|O2|Outcome|12 mcg TID|"Cobiprostone 36 mcg~Cobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID)"
1031687|NCT00737594|O1|Outcome|Placebo|Placebo: 0 mcg capsules three times daily (TID)
1031544|NCT00738374|P2|Participant Flow|CLB + R: Completed Induction Treament But Not Randomized|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants were not randomized to receive further treatment or observation.
1031545|NCT00738374|P1|Participant Flow|Chlorambucil (CLB) Plus (+) Rituximab (R): Induction Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 milligrams per square meter (mg/m^2), orally (PO) as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, intravenously (IV), on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with complete response (CR), complete response with incomplete bone marrow recovery (CRi), or partial response (PR) were randomized to receive either rituximab, 375 mg/m^2, IV, every 8 weeks for up to 24 months, or to be observed for up to 24 months with no further treatment.
1031546|NCT00738374|O2|Outcome|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
1031547|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
1031548|NCT00738374|O2|Outcome|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
1031549|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
1031550|NCT00738374|O2|Outcome|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
1031551|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
1031552|NCT00738374|O2|Outcome|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
1031553|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
1031554|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
1031555|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
1031585|NCT00738283|E1|Reported Event|Observational Group|Infants admitted to the NICU of Texas Children’s Hospital, Houston, TX who had a jejunostomy or ileostomy were recruited for the study. Neonates were enrolled if they had a jejunostomy or ileostomy and if their birth weight was > 500 grams. Infants were excluded from the study if they had any other major congenital anomalies (including congenital heart disease and cystic fibrosis), or if they were believed to be unlikely to survive to hospital discharge based on their cardiopulmonary disease.
1031556|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
1031557|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
1031558|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
1031559|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
1031560|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
1031561|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
1031562|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
1031563|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
1031564|NCT00738374|O2|Outcome|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
1031565|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
1031566|NCT00738374|O1|Outcome|CLB + R: Induction Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8.
1031567|NCT00738374|O2|Outcome|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
1031568|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
1031569|NCT00738374|O1|Outcome|CLB + R: Induction Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8.
1031570|NCT00738374|O2|Outcome|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
1031571|NCT00738374|O1|Outcome|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
1031572|NCT00738374|O1|Outcome|CLB + R: All Participants|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
1031573|NCT00738374|E3|Reported Event|CLB + R: Observation|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to be observed for up to 24 months and received no further treatment.
1031574|NCT00738374|E2|Reported Event|CLB + R: Maintenance Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive rituximab, 375 mg/m^2, IV, once every 8 weeks for a total of 12 infusions for up to 24 months.
1031575|NCT00738374|E1|Reported Event|CLB + R: Induction Treatment|Participants completed an 8-month induction treatment phase where they received 8 (4-week) courses of treatment consisting of: CLB, 8 mg/m^2, PO as film-coated tablets, daily (dose could be divided in halves or thirds to prevent nausea), on Days 1-7 of Courses 1 and 2, Days 2-8 of Course 3, and Days 1-7 of Courses 4-8; and rituximab, 375 mg/m^2, IV, on Day 1 of Course 3, and 500 mg/m^2, IV, on Day 1 of Courses 4-8. Participants with CR, CRi, or PR were randomized to receive either rituximab, 375 mg/m^2, IV, once every 8 weeks for up to 24 months (up to 12 infusions), or to be observed for up to 24 months with no further treatment.
1031576|NCT00738361|B1|Baseline|NAb-paclitaxel|Nab-paclitaxel will be administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
1031577|NCT00738361|P1|Participant Flow|Nab-paclitaxel|Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
1031578|NCT00738361|O1|Outcome|Nab-paclitaxel|Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
1031579|NCT00738361|O1|Outcome|Nab-paclitaxel|Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
1031580|NCT00738361|O1|Outcome|Nab-paclitaxel|"Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.~nab-paclitaxel: 150 mg/m2 weekly for 3 of 4 weeks every 28 days."
1031581|NCT00738361|E1|Reported Event|NAb-paclitaxel|Nab-paclitaxel will be administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
1031582|NCT00738283|B1|Baseline|Observational Group|Infants admitted to the NICU of Texas Children’s Hospital, Houston, TX who had a jejunostomy or ileostomy were recruited for the study. Neonates were enrolled if they had a jejunostomy or ileostomy and if their birth weight was > 500 grams. Infants were excluded from the study if they had any other major congenital anomalies (including congenital heart disease and cystic fibrosis), or if they were believed to be unlikely to survive to hospital discharge based on their cardiopulmonary disease.
1031583|NCT00738283|P1|Participant Flow|Observational Group|Infants admitted to the NICU of Texas Children’s Hospital, Houston, TX who had a jejunostomy or ileostomy were recruited for the study. Neonates were enrolled if they had a jejunostomy or ileostomy and if their birth weight was > 500 grams. Infants were excluded from the study if they had any other major congenital anomalies (including congenital heart disease and cystic fibrosis), or if they were believed to be unlikely to survive to hospital discharge based on their cardiopulmonary disease.
1031584|NCT00738283|O1|Outcome|Observational Group|Infants admitted to the NICU of Texas Children's Hospital, Houston, TX who had a jejunostomy or ileostomy were recruited for the study. Neonates were enrolled if they had a jejunostomy or ileostomy and if their birth weight was > 500 grams. Infants were excluded from the study if they had any other major congenital anomalies (including congenital heart disease and cystic fibrosis), or if they were believed to be unlikely to survive to hospital discharge based on their cardiopulmonary disease.
1031587|NCT00737737|B2|Baseline|Placebo|Participants will receive a similar number of matched placebo tablets over a period of 4 weeks
1031588|NCT00737737|B1|Baseline|Opioid|"Participants will receive MS Contin over a 4 week period starting at 15 mg bid. Doses will titrated upwards as tolerated by increments of 15-30 mg to a highest attained dose or a maximum dose of 90 mg~MS Contin"
1031589|NCT00737737|P2|Participant Flow|Placebo|Participants will receive a similar number of matched placebo tablets over a period of 4 weeks
1031590|NCT00737737|P1|Participant Flow|Opioid|"Participants will receive MS Contin over a 4 week period starting at 15 mg bid. Doses will titrated upwards as tolerated by increments of 15-30 mg to a highest attained dose or a maximum dose of 90 mg~MS Contin"
1031591|NCT00737737|O2|Outcome|Placebo|Participants will receive a similar number of matched placebo tablets over a period of 4 weeks
1031592|NCT00737737|O1|Outcome|Opioid|"Participants will receive MS Contin over a 4 week period starting at 15 mg bid. Doses will titrated upwards as tolerated by increments of 15-30 mg to a highest attained dose or a maximum dose of 90 mg~MS Contin"
1031593|NCT00737737|O2|Outcome|Placebo|Participants will receive a similar number of matched placebo tablets over a period of 4 weeks
1031594|NCT00737737|O1|Outcome|Opioid|"Participants will receive MS Contin over a 4 week period starting at 15 mg bid. Doses will titrated upwards as tolerated by increments of 15-30 mg to a highest attained dose or a maximum dose of 90 mg~MS Contin"
1031595|NCT00737737|E2|Reported Event|Placebo|Participants will receive a similar number of matched placebo tablets over a period of 4 weeks
1031596|NCT00737737|E1|Reported Event|Opioid|"Participants will receive MS Contin over a 4 week period starting at 15 mg bid. Doses will titrated upwards as tolerated by increments of 15-30 mg to a highest attained dose or a maximum dose of 90 mg~MS Contin"
1031597|NCT00737711|B1|Baseline|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
1031598|NCT00737711|P1|Participant Flow|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 microgram per kilogram of body weight (mcg/kg) of Methoxy polyethylene glycol-epoetin beta (MIRCERA/RO0503821), intravenously once every two weeks for 16 weeks. A telephonic / physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
1031599|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
1031600|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
1031601|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
1031602|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
1031603|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
1031604|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
1031605|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
1031606|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
1031607|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
1031608|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
1031609|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
1031610|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
1031611|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
1031612|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
1031688|NCT00737594|E3|Reported Event|18 mcg TID|"Cobiprostone 54 mcg~Cobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID)"
1031613|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
1031614|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
1031615|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
1031616|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
1031617|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
1031618|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
1031619|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
1031620|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
1031621|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
1031622|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
1031623|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
1031624|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
1031625|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
1031626|NCT00737711|O1|Outcome|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
1031627|NCT00737711|E1|Reported Event|MIRCERA|Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
1031628|NCT00737672|B3|Baseline|Total|Total of all reporting groups
1031629|NCT00737672|B2|Baseline|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm.~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis."
1031630|NCT00737672|B1|Baseline|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm.~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis."
1031631|NCT00737672|P2|Participant Flow|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA)in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
1031632|NCT00737672|P1|Participant Flow|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
1031633|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
1031634|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
1031635|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
1031689|NCT00737594|E2|Reported Event|12 mcg TID|"Cobiprostone 36 mcg~Cobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID)"
1031690|NCT00737594|E1|Reported Event|Placebo|Placebo: 0 mcg capsules three times daily (TID)
1031691|NCT00737568|B3|Baseline|Total|Total of all reporting groups
1031636|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
1031696|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
1031637|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
1031638|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
1031639|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
1031640|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
1031641|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
1031642|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
1031643|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
1031644|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
1031645|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
1031646|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
1031647|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
1031648|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
1031649|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
1031650|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
1031651|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
1031652|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
1031653|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
1031692|NCT00737568|B2|Baseline|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
1031693|NCT00737568|B1|Baseline|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
1034378|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
1031654|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
1031655|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
1031656|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
1031657|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
1031658|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
1031659|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
1031660|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
1031661|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
1031662|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
1031663|NCT00737672|O2|Outcome|PTA Treatment Group|"Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm~Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis"
1031664|NCT00737672|O1|Outcome|VIABAHN Treatment Group|"Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm~GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis"
1031665|NCT00737672|E2|Reported Event|PTA Treatment Group|Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm
1031666|NCT00737672|E1|Reported Event|VIABAHN Treatment Group|Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm
1031667|NCT00737633|B3|Baseline|Total|Total of all reporting groups
1031668|NCT00737633|B2|Baseline|72-week Population|subjects who were randomized to active during previous study
1031669|NCT00737633|B1|Baseline|16-week Population|subjects who were randomized to placebo in previous study
1031670|NCT00737633|P2|Participant Flow|72-week Population|Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
1031671|NCT00737633|P1|Participant Flow|16-week Population|Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
1031672|NCT00737633|O2|Outcome|72-week Population|Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
1031673|NCT00737633|O1|Outcome|16-week Population|Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
1031674|NCT00737633|O2|Outcome|72-week Population|Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
1031675|NCT00737633|O1|Outcome|16-week Population|Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
1031676|NCT00737633|E2|Reported Event|72-week Population|subjects who were randomized to active during previous study
1031677|NCT00737633|E1|Reported Event|16-week Population|subjects who were randomized to placebo in previous study
1031678|NCT00737594|B4|Baseline|Total|Total of all reporting groups
1031679|NCT00737594|B3|Baseline|18 mcg TID|"Cobiprostone 54 mcg~Cobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID)"
1031680|NCT00737594|B2|Baseline|12 mcg TID|"Cobiprostone 36 mcg~Cobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID)"
1031681|NCT00737594|B1|Baseline|Placebo|Placebo: 0 mcg capsules three times daily (TID)
1031682|NCT00737594|P3|Participant Flow|18 mcg TID|"Cobiprostone 54 mcg~Cobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID)"
1031683|NCT00737594|P2|Participant Flow|12 mcg TID|"Cobiprostone 36 mcg~Cobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID)"
1031684|NCT00737594|P1|Participant Flow|Placebo|Placebo: 0 mcg capsules three times daily (TID)
1031685|NCT00737594|O3|Outcome|18 mcg TID|"Cobiprostone 54 mcg~Cobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID)"
1031694|NCT00737568|P2|Participant Flow|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
1031695|NCT00737568|P1|Participant Flow|Tenofovir DF|Tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg tablet once daily plus emtricitabine (FTC)/TDF placebo tablet once daily
1080195|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
1031697|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
1031698|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
1031699|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
1031700|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
1031701|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
1031702|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
1031703|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
1031704|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
1031705|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
1031706|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
1031707|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
1031708|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
1031709|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
1031710|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
1031711|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
1031712|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
1031713|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
1031714|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
1031715|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
1031716|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
1031717|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
1031718|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
1031719|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
1031720|NCT00737568|O2|Outcome|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
1031721|NCT00737568|O1|Outcome|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
1031722|NCT00737568|E2|Reported Event|FTC/Tenofovir DF|FTC/TDF 200/300 mg tablet once daily plus TDF placebo tablet once daily
1031723|NCT00737568|E1|Reported Event|Tenofovir DF|TDF 300 mg tablet once daily plus FTC/TDF placebo tablet once daily
1031724|NCT00737529|B1|Baseline|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal
1031725|NCT00737529|P1|Participant Flow|Lenalidomide|"Single agent lenalidomide~Lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal."
1031726|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
1031727|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
1031728|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
1031729|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
1032207|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
1031755|NCT00737464|P1|Participant Flow|Mircera|Eligible participants with chronic renal anemia were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
1031756|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
1031730|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
1031731|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
1031732|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
1031733|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
1031734|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
1031735|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
1031736|NCT00737529|O1|Outcome|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
1031737|NCT00737529|E1|Reported Event|Lenalidomide|Single agent lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal
1031738|NCT00737477|B1|Baseline|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
1031739|NCT00737477|P1|Participant Flow|Mircera in Chronic Kidney Disease (CKD)-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with erythropoiesis-stimulating agent (ESA) therapy received subcutaneous (SC) methoxy polyethylene glycol-epoetin beta (Mircera), also known as continuous erythropoietin receptor activator (CERA), every 4 weeks in this single-arm study. The first dose of 120 or 200 micrograms (mcg) during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the dose adaptation period (DAP) to maintain target hemoglobin (Hb) concentrations within 10 to 12 grams per deciliter (g/dL). Treatment continued during a designated efficacy evaluation period (EEP) from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
1031740|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
1031741|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
1031754|NCT00737464|B1|Baseline|Mircera|Eligible participants with chronic renal anemia were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
1031839|NCT00737100|O1|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
1031742|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
1031743|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
1031744|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
1031745|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
1031746|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
1031747|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
1031748|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
1031749|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
1031750|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
1031751|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
1031752|NCT00737477|O1|Outcome|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
1031753|NCT00737477|E1|Reported Event|Mircera in CKD-Related Anemia|Participants with CKD-related anemia undergoing peritoneal dialysis and who were previously treated with ESA therapy received SC Mircera/CERA every 4 weeks in this single-arm study. The first dose of 120 or 200 mcg during Week 0 was based upon the dose of ESA received during the initial 4-week screening period, while subsequent doses were adjusted from Weeks 4 to 12 during the DAP to maintain target Hb concentrations within 10 to 12 g/dL. Treatment continued during a designated EEP from Weeks 16 to 24 and an additional follow-up period from Weeks 28 to 48.
1031838|NCT00737100|O2|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
1031757|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
1031758|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
1031759|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
1031760|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
1031761|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
1031762|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
1031763|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
1031764|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
1031765|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
1031766|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
1031767|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
1031768|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
1031769|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
1031770|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
1031771|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
1031772|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
1031773|NCT00737464|O1|Outcome|Mircera|Eligible participants were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
1031774|NCT00737464|E1|Reported Event|Mircera|Eligible participants with chronic renal anemia were administered methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.
1031775|NCT00737438|B1|Baseline|All Patients|ALL patients - Pre-operative Chemotherapy Plus Bevacizumab with Early Salvage Therapy in Patients with Locally Advanced but Resectable Gastric and GEJ Adenocarcinoma
1031776|NCT00737438|P1|Participant Flow|All Patients|ALL patients - Pre-operative Chemotherapy Plus Bevacizumab with Early Salvage Therapy in Patients with Locally Advanced but Resectable Gastric and GEJ Adenocarcinoma
1031777|NCT00737438|O1|Outcome|All Patients|ALL patients - Pre-operative Chemotherapy Plus Bevacizumab with Early Salvage Therapy in Patients with Locally Advanced but Resectable Gastric and GEJ Adenocarcinoma
1031778|NCT00737438|E1|Reported Event|All Patients|ALL patients - Pre-operative Chemotherapy Plus Bevacizumab with Early Salvage Therapy in Patients with Locally Advanced but Resectable Gastric and GEJ Adenocarcinoma
1031779|NCT00737360|B1|Baseline|TAS-106|
1031780|NCT00737360|P1|Participant Flow|TAS-106|
1031781|NCT00737360|O1|Outcome|TAS-106|
1031782|NCT00737360|O1|Outcome|TAS-106|
1031783|NCT00737360|O1|Outcome|TAS-106|
1031784|NCT00737360|O1|Outcome|TAS-106|
1031785|NCT00737360|E1|Reported Event|TAS-106|
1031786|NCT00737282|B3|Baseline|Total|Total of all reporting groups
1031787|NCT00737282|B2|Baseline|Proellex 50 mg|"Proellex 50 mg once daily~Proellex 50 mg: Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
1031788|NCT00737282|B1|Baseline|25 mg Proellex|"Proellex 25 mg once daily~Proellex 25 mg: One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
1031789|NCT00737282|P1|Participant Flow|Proellex|"Proellex 25 or 50 mg once daily~One capsule Proellex 25 mg or 50 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
1031790|NCT00737282|O2|Outcome|Proellex 50 mg|"Proellex 50 mg once daily~Proellex 50 mg: Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
1031791|NCT00737282|O1|Outcome|25 mg Proellex|"Proellex 25 mg once daily~Proellex 25 mg: One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
1031792|NCT00737282|E2|Reported Event|Proellex 50 mg|"Proellex 50 mg once daily~Proellex 50 mg: Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
1032208|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
1031793|NCT00737282|E1|Reported Event|25 mg Proellex|"Proellex 25 mg once daily~Proellex 25 mg: One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle"
1031794|NCT00737243|B1|Baseline|Patients With Tumor Assays Performed|Of 289 patients initially enrolled, 252 had successful assays performed. 37 patients had insufficient tissue for assay and came off study.
1031795|NCT00737243|P1|Participant Flow|All Patients With a Successful Tumor Assays Performed|Subjects in this group had a successful molecular assay of biopsy tissue
1031796|NCT00737243|O1|Outcome|Patients With Successful Tumor Assays Performed|In 252 participants successful assays were performed. In 29 participants the amount of tumour and/or viable RNA present in the biopsy specimen was inadequate.
1031797|NCT00737243|O2|Outcome|Less Treatment Responsive|Patients who received assay-directed therapy for tumors with a predicted median survival ≤ 12 months
1031798|NCT00737243|O1|Outcome|More Treatment Responsive|Patients who received assay-directed therapy for tumor types with a predicted median survival ≥ 12 months.
1031799|NCT00737243|E1|Reported Event|All Treated Patients|
1031800|NCT00737204|B3|Baseline|Total|Total of all reporting groups
1031801|NCT00737204|B2|Baseline|Placebo|Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
1031802|NCT00737204|B1|Baseline|Armodafinil|Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
1031803|NCT00737204|P2|Participant Flow|Placebo|Participants will receive a placebo pill (matching the active medication) for 4 weeks, then a 16-week course of armodafinil. Starting dose of is one placebo pill/day, increased weekly in the absence of clinical response and dose-limiting side effects to a maximum of 5 placebo pills/day.
1031804|NCT00737204|P1|Participant Flow|Armodafinil|Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil. Starting dose of armodafinil is 50 mg/day, increased weekly in the absence of clinical response and dose-limiting side effects to a maximum of 250 mg/day.
1031805|NCT00737204|O2|Outcome|Placebo|Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
1031806|NCT00737204|O1|Outcome|Armodafinil|Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
1031807|NCT00737204|O2|Outcome|Placebo|Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
1031808|NCT00737204|O1|Outcome|Armodafinil|Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
1031809|NCT00737204|O2|Outcome|Placebo|Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
1031810|NCT00737204|O1|Outcome|Armodafinil|Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
1031811|NCT00737204|O2|Outcome|Placebo|Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
1031812|NCT00737204|O1|Outcome|Armodafinil|Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
1031813|NCT00737204|E2|Reported Event|Placebo|Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
1031814|NCT00737204|E1|Reported Event|Armodafinil|Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
1031815|NCT00737178|B3|Baseline|Total|Total of all reporting groups
1031816|NCT00737178|B2|Baseline|Delayed IUD Insertion|IUD insertion four to six weeks after initiation of a medication abortion
1031817|NCT00737178|B1|Baseline|Immediate IUD Insertion|IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion
1031818|NCT00737178|P2|Participant Flow|Delayed IUD Insertion|IUD insertion four to six weeks after initiation of a medication abortion
1031819|NCT00737178|P1|Participant Flow|Immediate IUD Insertion|IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion
1031820|NCT00737178|O2|Outcome|Delayed IUD Insertion|IUD insertion four to six weeks after initiation of a medication abortion
1031821|NCT00737178|O1|Outcome|Immediate IUD Insertion|IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion
1031822|NCT00737178|O2|Outcome|Delayed IUD Insertion|IUD insertion four to six weeks after initiation of a medication abortion
1031823|NCT00737178|O1|Outcome|Immediate IUD Insertion|IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion
1031824|NCT00737178|O2|Outcome|Delayed IUD Insertion|IUD insertion four to six weeks after initiation of a medication abortion
1031825|NCT00737178|O1|Outcome|Immediate IUD Insertion|IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion
1031826|NCT00737178|E2|Reported Event|Delayed IUD Insertion|IUD insertion four to six weeks after initiation of a medication abortion
1031827|NCT00737178|E1|Reported Event|Immediate IUD Insertion|IUD insertion at the routine medication abortion follow-up visit one week after initiation of a medication abortion
1031828|NCT00737100|B4|Baseline|Total|Total of all reporting groups
1031829|NCT00737100|B3|Baseline|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
1031830|NCT00737100|B2|Baseline|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
1031831|NCT00737100|B1|Baseline|Placebo|Patients randomised to receive matching placebo
1031832|NCT00737100|P3|Participant Flow|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
1031833|NCT00737100|P2|Participant Flow|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
1031834|NCT00737100|P1|Participant Flow|Placebo|Patients randomised to receive matching placebo
1031835|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
1031836|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
1031837|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
1031840|NCT00737100|O2|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
1031841|NCT00737100|O1|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
1032215|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
1031842|NCT00737100|O2|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
1031843|NCT00737100|O1|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
1031844|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
1031845|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
1031846|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
1031847|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
1031848|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
1031849|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
1031850|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
1031851|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
1031852|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
1031853|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
1031854|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
1031855|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
1031856|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
1031857|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
1031858|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
1031859|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
1031860|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
1031861|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
1031862|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
1031863|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
1031864|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
1031865|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
1031866|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
1031867|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
1031868|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
1031869|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
1031870|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
1031871|NCT00737100|O3|Outcome|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
1031872|NCT00737100|O2|Outcome|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
1031873|NCT00737100|O1|Outcome|Placebo|Patients randomised to receive matching placebo
1031874|NCT00737100|E3|Reported Event|Tiotropium Respimat 5 Micrograms|Patients randomised to receive Tiotropium Respimat 5.0 micrograms once daily
1031875|NCT00737100|E2|Reported Event|Tiotropium Respimat 2.5 Micrograms|Patients randomised to receive Tiotropium Respimat 2.5 micrograms once daily
1031876|NCT00737100|E1|Reported Event|Placebo|Patients randomised to receive matching placebo
1031877|NCT00737061|B1|Baseline|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
1031878|NCT00737061|P1|Participant Flow|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
1031879|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
1031880|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
1031881|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
1031882|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
1031883|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
1031884|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
1031885|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
1031886|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
1031887|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
1031888|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
1031889|NCT00737061|O1|Outcome|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
1031890|NCT00737061|E1|Reported Event|Adiana Permanent Contraception System|Implantation of silicone matrix in fallopian tubes
1031891|NCT00737048|B4|Baseline|Total|Total of all reporting groups
1032209|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
1032210|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
1032028|NCT00736879|O2|Outcome|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032216|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
1031892|NCT00737048|B3|Baseline|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031893|NCT00737048|B2|Baseline|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031894|NCT00737048|B1|Baseline|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031895|NCT00737048|P3|Participant Flow|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031896|NCT00737048|P2|Participant Flow|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031897|NCT00737048|P1|Participant Flow|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031898|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031899|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031900|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031901|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031902|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031903|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031904|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031905|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031906|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031907|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031908|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031926|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031909|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031910|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031911|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031912|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031913|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031914|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031915|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031916|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031917|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031918|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031919|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031920|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031921|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031922|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031923|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031924|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031925|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1032027|NCT00736879|O3|Outcome|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1031927|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031928|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031929|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031930|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031931|NCT00737048|O3|Outcome|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031932|NCT00737048|O2|Outcome|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031933|NCT00737048|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031934|NCT00737048|E3|Reported Event|Acetaminophen and Placebo|Acetaminophen was administered as 650 milligram as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031935|NCT00737048|E2|Reported Event|Tramadol Hydrochloride and Placebo|Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed >= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031936|NCT00737048|E1|Reported Event|Tramadol Hydrochloride Plus Acetaminophen and Placebo|Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
1031937|NCT00736996|B4|Baseline|Total|Total of all reporting groups
1031938|NCT00736996|B3|Baseline|Placebo|Placebo: Matching oral tablet daily for 6 months
1031939|NCT00736996|B2|Baseline|Endurance Exercise Training|Endurance Exercise Training: Supervised, thrice-weekly, 45-75 minute sessions of treadmill walking, initially moderate intensity (50-60% of maximum heart rate), with progressive increases in intensity to the best of the subject's ability, up to 85% of maximal heart rate.
1031940|NCT00736996|B1|Baseline|Pioglitazone|Pioglitazone: 45mg oral tablet daily for 6 months
1031941|NCT00736996|P3|Participant Flow|Placebo|Placebo: Matching oral tablet daily for 6 months
1031942|NCT00736996|P2|Participant Flow|Endurance Exercise Training|Endurance Exercise Training: Supervised, thrice-weekly, 45-75 minute sessions of treadmill walking, initially moderate intensity (50-60% of maximum heart rate), with progressive increases in intensity to the best of the subject's ability, up to 85% of maximal heart rate.
1031943|NCT00736996|P1|Participant Flow|Pioglitazone|Pioglitazone: 45mg oral tablet daily for 6 months
1031944|NCT00736996|O3|Outcome|Placebo|Placebo: Matching oral tablet daily for 6 months
1031945|NCT00736996|O2|Outcome|Endurance Exercise Training|Endurance Exercise Training: Supervised, thrice-weekly, 45-75 minute sessions of treadmill walking, initially moderate intensity (50-60% of maximum heart rate), with progressive increases in intensity to the best of the subject's ability, up to 85% of maximal heart rate.
1031946|NCT00736996|O1|Outcome|Pioglitazone|Pioglitazone: 45mg oral tablet daily for 6 months
1031947|NCT00736996|O3|Outcome|Placebo|Placebo: Matching oral tablet daily for 6 months
1031948|NCT00736996|O2|Outcome|Endurance Exercise Training|Endurance Exercise Training: Supervised, thrice-weekly, 45-75 minute sessions of treadmill walking, initially moderate intensity (50-60% of maximum heart rate), with progressive increases in intensity to the best of the subject's ability, up to 85% of maximal heart rate.
1031949|NCT00736996|O1|Outcome|Pioglitazone|Pioglitazone: 45mg oral tablet daily for 6 months
1031950|NCT00736996|O3|Outcome|Placebo|Placebo: Matching oral tablet daily for 6 months
1031951|NCT00736996|O2|Outcome|Endurance Exercise Training|Endurance Exercise Training: Supervised, thrice-weekly, 45-75 minute sessions of treadmill walking, initially moderate intensity (50-60% of maximum heart rate), with progressive increases in intensity to the best of the subject's ability, up to 85% of maximal heart rate.
1031952|NCT00736996|O1|Outcome|Pioglitazone|Pioglitazone: 45mg oral tablet daily for 6 months
1031953|NCT00736996|E3|Reported Event|Placebo|Placebo: Matching oral tablet daily for 6 months
1032061|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
1031954|NCT00736996|E2|Reported Event|Endurance Exercise Training|Endurance Exercise Training: Supervised, thrice-weekly, 45-75 minute sessions of treadmill walking, initially moderate intensity (50-60% of maximum heart rate), with progressive increases in intensity to the best of the subject's ability, up to 85% of maximal heart rate.
1031955|NCT00736996|E1|Reported Event|Pioglitazone|Pioglitazone: 45mg oral tablet daily for 6 months
1031956|NCT00736957|B1|Baseline|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
1031957|NCT00736957|P1|Participant Flow|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
1031958|NCT00736957|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
1031959|NCT00736957|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
1031960|NCT00736957|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
1031961|NCT00736957|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
1031962|NCT00736957|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
1031963|NCT00736957|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
1031964|NCT00736957|O1|Outcome|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
1031965|NCT00736957|E1|Reported Event|Tramadol Hydrochloride Plus Acetaminophen (JNS013)|Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets was given orally four times daily (maximum dose was 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments was established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval was of at least 4 hours.
1031966|NCT00736944|B1|Baseline|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
1031967|NCT00736944|P1|Participant Flow|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
1031968|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
1031969|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
1031970|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
1031971|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
1031972|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
1031973|NCT00736944|O3|Outcome|FDG-PET/CT|
1031974|NCT00736944|O2|Outcome|CT Scan|
1031975|NCT00736944|O1|Outcome|Clinical Examination|
1031976|NCT00736944|O3|Outcome|FDG-PET/CT|
1031977|NCT00736944|O2|Outcome|CT Scan|
1031978|NCT00736944|O1|Outcome|Clinical Examination|
1031979|NCT00736944|O3|Outcome|FDG-PET/CT|
1031980|NCT00736944|O2|Outcome|CT Scan|
1031981|NCT00736944|O1|Outcome|Clinical Examination|
1031982|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
1031983|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
1031984|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
1031985|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
1031986|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
1031987|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
1031988|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
1031989|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
1031990|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
1031991|NCT00736944|O1|Outcome|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
1031992|NCT00736944|E1|Reported Event|Induction Chemo + RT + Cisplatin or Cetuximab|"Induction chemotherapy:~Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.~Post-Induction:~Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W."
1031993|NCT00736879|B5|Baseline|Total|Total of all reporting groups
1031994|NCT00736879|B4|Baseline|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1031995|NCT00736879|B3|Baseline|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1031996|NCT00736879|B2|Baseline|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1031997|NCT00736879|B1|Baseline|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1031998|NCT00736879|P4|Participant Flow|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1031999|NCT00736879|P3|Participant Flow|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032000|NCT00736879|P2|Participant Flow|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032001|NCT00736879|P1|Participant Flow|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032002|NCT00736879|O4|Outcome|5 mg Dapagliflozin|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032003|NCT00736879|O3|Outcome|2.5 mg Dapagliflozin|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032004|NCT00736879|O2|Outcome|1mg Dapagliflozin|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032005|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032006|NCT00736879|O4|Outcome|5 mg Dapagliflozin|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032007|NCT00736879|O3|Outcome|2.5 mg Dapagliflozin|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032008|NCT00736879|O2|Outcome|1mg Dapagliflozin|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032009|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032010|NCT00736879|O4|Outcome|5 mg Dapagliflozin|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032011|NCT00736879|O3|Outcome|2.5 mg Dapagliflozin|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032012|NCT00736879|O2|Outcome|1mg Dapagliflozin|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032013|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032014|NCT00736879|O4|Outcome|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032015|NCT00736879|O3|Outcome|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032016|NCT00736879|O2|Outcome|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032017|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032018|NCT00736879|O4|Outcome|5 mg Dapagliflozin|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032019|NCT00736879|O3|Outcome|2.5 mg Dapagliflozin|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032020|NCT00736879|O2|Outcome|1mg Dapagliflozin|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032021|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032022|NCT00736879|O4|Outcome|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032023|NCT00736879|O3|Outcome|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032024|NCT00736879|O2|Outcome|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032025|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032026|NCT00736879|O4|Outcome|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032211|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
1032029|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032030|NCT00736879|O4|Outcome|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032031|NCT00736879|O3|Outcome|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032032|NCT00736879|O2|Outcome|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032033|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032034|NCT00736879|O4|Outcome|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032035|NCT00736879|O3|Outcome|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032036|NCT00736879|O2|Outcome|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032037|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032038|NCT00736879|O4|Outcome|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032039|NCT00736879|O3|Outcome|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032040|NCT00736879|O2|Outcome|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032041|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032042|NCT00736879|O4|Outcome|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032043|NCT00736879|O3|Outcome|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032044|NCT00736879|O2|Outcome|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032045|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032046|NCT00736879|O4|Outcome|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032047|NCT00736879|O3|Outcome|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032048|NCT00736879|O2|Outcome|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032049|NCT00736879|O1|Outcome|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032050|NCT00736879|E4|Reported Event|Placebo|Placebo tablets matching either 1 mg, 2.5 mg, or 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032051|NCT00736879|E3|Reported Event|Dapagliflozin 5 mg|5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032052|NCT00736879|E2|Reported Event|Dapagliflozin 2.5 mg|2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032053|NCT00736879|E1|Reported Event|Dapagliflozin 1mg|1 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
1032054|NCT00736853|B1|Baseline|Entire Study Population|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets) during the open-label period. Participants received placebo or fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg (same dose which was used in second week of open-label period) in double-blind period.
1032055|NCT00736853|P3|Participant Flow|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
1032056|NCT00736853|P2|Participant Flow|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
1032057|NCT00736853|P1|Participant Flow|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
1032058|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
1032059|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
1032060|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
1032128|NCT00736489|P4|Participant Flow|DCPABEa|Formoterol 9 Mcg followed by AZD3199 1920 Mcg followed by Placebo followed by AZD3199 120 Mcg followed by AZD3199 480 Mcg followed by Formoterol 36 Mcg.
1032062|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
1032063|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
1032064|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
1032065|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
1032066|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
1032067|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
1032068|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
1032069|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
1032070|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
1032071|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
1032072|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
1032073|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
1032074|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
1032075|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
1032076|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
1032077|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
1032078|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
1032079|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
1032080|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
1032081|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
1032082|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
1032083|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
1032084|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
1032085|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
1032086|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
1032087|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
1032088|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
1032089|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
1032127|NCT00736489|P5|Participant Flow|EDABCPa|Formoterol 36 Mcg followed by Formoterol 9 Mcg followed by AZD3199 120 Mcg followed by AZD3199 480 Mcg followed by AZD3199 1920 Mcg followed by Placebo.
1032090|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
1032091|NCT00736853|O2|Outcome|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
1032092|NCT00736853|O1|Outcome|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
1032093|NCT00736853|E3|Reported Event|Placebo (Double-Blind)|Matching placebo was given up to 4 weeks.
1032094|NCT00736853|E2|Reported Event|Tramadol Hydrochloride and Acetaminophen (Double-Blind)|Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
1032095|NCT00736853|E1|Reported Event|Tramadol Hydrochloride and Acetaminophen (Open-Label)|Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
1032096|NCT00736840|B1|Baseline|CLD (Chronic Liver Disease)|Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material)
1032097|NCT00736840|P1|Participant Flow|CLD (Chronic Liver Disease)|Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material)
1032098|NCT00736840|O1|Outcome|CLD (Chronic Liver Disease)|Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material)
1032099|NCT00736840|O1|Outcome|CLD (Chronic Liver Disease)|Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material)
1032100|NCT00736840|E1|Reported Event|CLD (Chronic Liver Disease)|Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material)
1032101|NCT00736723|B3|Baseline|Total|Total of all reporting groups
1032102|NCT00736723|B2|Baseline|Postoperative/Posttraumatic Patients With Septic Shock|Postoperative/posttraumatic critically ill patients with septic shock
1032103|NCT00736723|B1|Baseline|Postoperative/Posttraumatic Patients With Non-septic Shock|Postoperative/posttraumatic critically ill patients with non-septic shock
1032104|NCT00736723|P2|Participant Flow|Patients With Septic Shock|critically ill surgical patients admitted from 01 July 2008 to 31 Dec 2008 in the ICU revealing septic shock
1032105|NCT00736723|P1|Participant Flow|Patients With Non-septic Shock|critically ill surgical patients admitted from 01 July 2008 to 31 Dec 2008 in the ICU revealing non-septic shock
1032106|NCT00736723|O2|Outcome|Patients Septic Shock|Postoperative/posttraumatic critically ill patients with septic shock
1032107|NCT00736723|O1|Outcome|Patients Non-septic Shock|Postoperative/posttraumatic critically ill patients with non-septic shock
1032108|NCT00736723|E2|Reported Event|Postoperative/Posttraumatic Patients With Septi|Postoperative/posttraumatic critically ill patients with septic shock
1032109|NCT00736723|E1|Reported Event|Postoperative/Posttraumatic Patients With Non-septic Shock|Postoperative/posttraumatic critically ill patients with non-septic shock
1032110|NCT00736580|B3|Baseline|Total|Total of all reporting groups
1032111|NCT00736580|B2|Baseline|Sharp Needles|Cesarean delivery performed with sharp surgical needles.
1032112|NCT00736580|B1|Baseline|Blunt Needles|Cesarean Delivery Performed with Blunt-tipped surgical Needles
1032113|NCT00736580|P2|Participant Flow|Sharp Needles|Cesarean delivery performed with sharp surgical needles.
1032114|NCT00736580|P1|Participant Flow|Blunt Needles|Cesarean Delivery Performed with Blunt-tipped surgical Needles
1032115|NCT00736580|O2|Outcome|Sharp Needles|Cesarean delivery performed with sharp surgical needles.
1032116|NCT00736580|O1|Outcome|Blunt Needles|Cesarean Delivery Performed with Blunt-tipped surgical Needles
1032117|NCT00736580|E2|Reported Event|Sharp Needles|Cesarean delivery performed with sharp surgical needles.
1032118|NCT00736580|E1|Reported Event|Blunt Needles|Cesarean Delivery Performed with Blunt-tipped surgical Needles
1032119|NCT00736502|B1|Baseline|Nevirapine|Patients treated with 200 mg Nevirapine twice daily (administered orally).
1032120|NCT00736502|P1|Participant Flow|Nevirapine|Patients treated with 200 mg Nevirapine twice daily (administered orally).
1032121|NCT00736502|O1|Outcome|Nevirapine|Patients treated with 200 mg Nevirapine twice daily (administered orally).
1032122|NCT00736502|O1|Outcome|Nevirapine|Patients treated with 200 mg Nevirapine twice daily (administered orally).
1032123|NCT00736502|O1|Outcome|Nevirapine|Patients treated with 200 mg Nevirapine twice daily (administered orally).
1032124|NCT00736502|E1|Reported Event|Nevirapine|Patients treated with 200 mg Nevirapine twice daily (administered orally).
1032125|NCT00736489|B1|Baseline|Baseline Total|Total number of patients randomized and treated in the study
1032126|NCT00736489|P6|Participant Flow|PEBCDAa|Placebo followed by Formoterol 36 Mcg followed by AZD3199 480 Mcg followed by AZD3199 1920 Mcg followed by Formoterol 9 Mcg followed by AZD3199 120 Mcg.
1032196|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
1032129|NCT00736489|P3|Participant Flow|CBEPADa|AZD3199 1920 Mcg followed by AZD3199 480 Mcg followed by Formoterol 36 Mcg followed by Placebo followed by AZD3199 120 Mcg followed by Formoterol 9 Mcg .
1032130|NCT00736489|P2|Participant Flow|BADEPCa|AZD3199 480 Mcg followed by AZD3199 120 Mcg followed by Formoterol 9 Mcg followed by Formoterol 36 Mcg followed by Placebo followed by AZD3199 1920 Mcg.
1032131|NCT00736489|P1|Participant Flow|APCDEBa|AZD3199 120 Mcg followed by Placebo followed by AZD3199 1920 Mcg followed by Formoterol 9 Mcg followed by Formoterol 36 Mcg followed by AZD3199 480 Mcg.
1032132|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
1032133|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
1032134|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
1032135|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
1032136|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
1032137|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
1032138|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
1032139|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
1032140|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
1032141|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
1032142|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
1032143|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
1032144|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
1032145|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
1032146|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
1032147|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
1032148|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
1032149|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
1032150|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
1032151|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
1032152|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
1032153|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
1032154|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
1032155|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
1032156|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
1032157|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
1032158|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
1032159|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
1032160|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
1032161|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
1032162|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
1032163|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
1032164|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
1032165|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
1032166|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
1032167|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
1032168|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
1032169|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
1032170|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
1032171|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
1032172|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
1032173|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
1032174|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
1032175|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
1032176|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
1032177|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
1032178|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
1032179|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
1032180|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
1032181|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
1032182|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
1032183|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
1032184|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
1032185|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
1032186|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
1032187|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
1032188|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
1032189|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
1032190|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
1032191|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
1032192|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
1032193|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
1032194|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
1032195|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
1032212|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
1032450|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032217|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
1032218|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
1032219|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
1032220|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
1032221|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
1032222|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
1032223|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
1032224|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
1032225|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
1032226|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
1032227|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
1032228|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
1032229|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
1032230|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
1032231|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
1032232|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
1032233|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
1032234|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
1032235|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
1032236|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
1032237|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
1032238|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
1032239|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
1032240|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
1032241|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
1032242|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
1032243|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
1032244|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
1032245|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
1032246|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
1032247|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
1032248|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
1032249|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
1032250|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
1032251|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
1032252|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
1032253|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
1032254|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
1032255|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
1032256|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
1032257|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
1032258|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
1032259|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
1032260|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
1032261|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
1032262|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
1032263|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
1032264|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
1032265|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
1032266|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
1032267|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
1032268|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
1032269|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
1032270|NCT00736489|O6|Outcome|Placebo|Placebo inhaled via Turbuhaler
1032271|NCT00736489|O5|Outcome|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
1032272|NCT00736489|O4|Outcome|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
1032273|NCT00736489|O3|Outcome|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
1032274|NCT00736489|O2|Outcome|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
1032275|NCT00736489|O1|Outcome|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
1032276|NCT00736489|E6|Reported Event|Placebo|Placebo inhaled via Turbuhaler
1032277|NCT00736489|E5|Reported Event|Formoterol 36 mcg|Formoterol 36 Mcg inhaled via Turbuhaler
1032278|NCT00736489|E4|Reported Event|Formoterol 9 mcg|Formoterol 9 Mcg inhaled via Turbuhaler
1032279|NCT00736489|E3|Reported Event|AZD3199 1920 mcg|AZD3199 1920 Mcg inhaled via Turbuhaler
1032280|NCT00736489|E2|Reported Event|AZD3199 480 mcg|AZD3199 480 Mcg inhaled via Turbuhaler
1032281|NCT00736489|E1|Reported Event|AZD3199 120 mcg|AZD3199 120 Mcg inhaled via Turbuhaler
1032282|NCT00736476|B3|Baseline|Total|Total of all reporting groups
1032283|NCT00736476|B2|Baseline|Group II (Placebo)|Subjects received three injections of Placebo at 0, 1, and 2 months
1032284|NCT00736476|B1|Baseline|Group I (HP Vaccine)|Subjects received three injections of HP Vaccine at 0, 1, and 2 months.
1032285|NCT00736476|P2|Participant Flow|Group II (Placebo)|Subjects received three injections of Placebo at 0, 1, and 2 months,followed by H.pylori challenge (oral administration of infectious HP inoculum)1 month later.
1032286|NCT00736476|P1|Participant Flow|Group I (HP Vaccine)|Subjects received three injections of HP Vaccine at 0, 1, and 2 months, followed by H.pylori challenge(oral administration of infectious HP inoculum)1 month later.
1032287|NCT00736476|O2|Outcome|Group II (Placebo)|Subjects received three injections of Placebo (only aluminum hydroxide adjuvant) at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later.
1032288|NCT00736476|O1|Outcome|Group I (HP Vaccine)|Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later.
1032289|NCT00736476|O2|Outcome|Group II (Placebo)|Subjects received three injections of Placebo (only aluminum hydroxide adjuvant) at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later.
1032290|NCT00736476|O1|Outcome|Group I (HP Vaccine)|Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later.
1032291|NCT00736476|O4|Outcome|Group II (Placebo) Non-Infected|Subjects received three injections of Placebo (only aluminum hydroxide adjuvant) at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) ≥1 month after 3rd injection.
1032292|NCT00736476|O3|Outcome|Group II (Placebo) Infected|Subjects received three injections of Placebo (only aluminum hydroxide adjuvant) at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) ≥1 month after 3rd injection.
1032293|NCT00736476|O2|Outcome|Group I (HP Vaccine) Non-Infected|Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) ≥1 month after 3rd injection.
1032294|NCT00736476|O1|Outcome|Group I (HP Vaccine) Infected|Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) ≥1 month after 3rd injection.
1032295|NCT00736476|O2|Outcome|Group II (Placebo)|Subjects received three injections of Placebo (only aluminum hydroxide adjuvant) at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) ≥1 month after 3rd injection.
1032296|NCT00736476|O1|Outcome|Group I (HP Vaccine)|Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) ≥1 month after 3rd injection.
1032297|NCT00736476|O2|Outcome|Group II (Placebo)|Subjects received three injections of Placebo (only aluminum hydroxide adjuvant) at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) ≥1 month after 3rd injection.
1032298|NCT00736476|O1|Outcome|Group I (HP Vaccine)|Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) ≥1 month after 3rd injection.
1032299|NCT00736476|O2|Outcome|Group II (Placebo)|Subjects received three injections of Placebo (only aluminum hydroxide adjuvant) at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later.
1032300|NCT00736476|O1|Outcome|Group I (HP Vaccine)|Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later.
1032301|NCT00736476|O2|Outcome|Group II (Placebo)|Subjects received three injections of Placebo (only aluminum hydroxide adjuvant) at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later.
1032302|NCT00736476|O1|Outcome|Group I (HP Vaccine)|Subjects received three injections of H.pylori(HP) Vaccine at 0, 1, and 2 months, followed by a H.pylori challenge (oral administration of infectious HP inoculum) 1 month later.
1032303|NCT00736476|E2|Reported Event|Group II (Placebo)|Subjects received three injections of Placebo at 0, 1, and 2 months
1032304|NCT00736476|E1|Reported Event|Group I (HP Vaccine)|Subjects received three injections of HP Vaccine at 0, 1, and 2 months.
1032305|NCT00736385|B3|Baseline|Total|Total of all reporting groups
1032306|NCT00736385|B2|Baseline|Placebo|"Placebo capsule~Placebo: placebo 2000 mg daily for 12 months"
1032307|NCT00736385|B1|Baseline|Metformin|"Metformin XR 2000 mg daily~Glucophage (Metformin): metformin XR 2000 mg daily for 12 months"
1032308|NCT00736385|P2|Participant Flow|Placebo|"Placebo capsule~Placebo: placebo 2000 mg daily for 12 months"
1032309|NCT00736385|P1|Participant Flow|Metformin|"Metformin XR (extended-release) 2000 mg daily~Glucophage (Metformin): metformin XR 2000 mg daily for 12 months"
1032310|NCT00736385|O2|Outcome|Placebo|"Placebo capsule~Placebo: placebo 2000 mg daily for 12 months"
1032311|NCT00736385|O1|Outcome|Metformin|"Metformin XR 2000 mg daily~Glucophage (Metformin): metformin XR 2000 mg daily for 12 months"
1032312|NCT00736385|O2|Outcome|Placebo|"Placebo capsule~Placebo: placebo 2000 mg daily for 12 months"
1032313|NCT00736385|O1|Outcome|Metformin|"Metformin XR 2000 mg daily~Glucophage (Metformin): metformin XR 2000 mg daily for 12 months"
1032314|NCT00736385|O2|Outcome|Placebo|"Placebo capsule~Placebo: placebo 2000 mg daily for 12 months"
1032315|NCT00736385|O1|Outcome|Metformin|"Metformin XR 2000 mg daily~Glucophage (Metformin): metformin XR 2000 mg daily for 12 months"
1032316|NCT00736385|O2|Outcome|Placebo|"Placebo capsule~Placebo: placebo 2000 mg daily for 12 months"
1032317|NCT00736385|O1|Outcome|Metformin|"Metformin XR 2000 mg daily~Glucophage (Metformin): metformin XR 2000 mg daily for 12 months"
1032318|NCT00736385|E2|Reported Event|Placebo|"Placebo capsule~Placebo: placebo 2000 mg daily for 12 months"
1032319|NCT00736385|E1|Reported Event|Metformin|"Metformin XR 2000 mg daily~Glucophage (Metformin): metformin XR 2000 mg daily for 12 months"
1032320|NCT00736333|B1|Baseline|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
1032376|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
1032321|NCT00736333|P1|Participant Flow|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
1032322|NCT00736333|O1|Outcome|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
1032323|NCT00736333|O1|Outcome|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
1032324|NCT00736333|O1|Outcome|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
1032325|NCT00736333|O1|Outcome|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
1032326|NCT00736333|O1|Outcome|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
1032327|NCT00736333|O1|Outcome|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
1032328|NCT00736333|E1|Reported Event|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxorubicin 50 mg/m^2 given every 4 weeks for up to 6 cycles
1032329|NCT00736255|B3|Baseline|Total|Total of all reporting groups
1032330|NCT00736255|B2|Baseline|NRT and Placebo|The second group will receive matching placebo and NRT after the quit date.
1032331|NCT00736255|B1|Baseline|LDX and NRT|• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
1032332|NCT00736255|P2|Participant Flow|NRT and Placebo|The second group will receive matching placebo and NRT after the quit date.
1032333|NCT00736255|P1|Participant Flow|LDX and NRT|• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
1032334|NCT00736255|O2|Outcome|NRT and Placebo|The second group will receive matching placebo and NRT after the quit date.
1032335|NCT00736255|O1|Outcome|LDX and NRT|• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
1032336|NCT00736255|O2|Outcome|NRT and Placebo|The second group will receive matching placebo and NRT after the quit date.
1032337|NCT00736255|O1|Outcome|LDX and NRT|• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
1032338|NCT00736255|O2|Outcome|NRT and Placebo|The second group will receive matching placebo and NRT after the quit date.
1032339|NCT00736255|O1|Outcome|LDX and NRT|• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
1032340|NCT00736255|E2|Reported Event|NRT and Placebo|The second group will receive matching placebo and NRT after the quit date.
1032341|NCT00736255|E1|Reported Event|LDX and NRT|• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
1032342|NCT00736242|B1|Baseline|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
1032343|NCT00736242|P1|Participant Flow|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus ribavirin (RBV) according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
1032344|NCT00736242|O1|Outcome|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
1032345|NCT00736242|O1|Outcome|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
1032346|NCT00736242|O1|Outcome|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
1032347|NCT00736242|O1|Outcome|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
1032348|NCT00736242|O1|Outcome|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
1032349|NCT00736242|O1|Outcome|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
1032350|NCT00736242|O1|Outcome|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
1032351|NCT00736242|O1|Outcome|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
1032352|NCT00736242|E1|Reported Event|PEG-IFN Alfa-2b + RBV|Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
1032353|NCT00736229|B4|Baseline|Total|Total of all reporting groups
1032354|NCT00736229|B3|Baseline|Intensive|In 2008, the Mid America Heart and Vascular Institute implemented an intensive glucose control protocol using IV insulin in critically ill hyperglycemic patients hospitalized with ACS. All patients admitted with blood glucose ≥140 mg/dL received intravenous insulin infusion to achieve a target blood glucose 90-120 mg/dL. The efficacy of this protocol has been studied compared to ACS patients with admission blood glucose >140 mg/dL admitted prior to protocol implementation.
1032355|NCT00736229|B2|Baseline|Moderate|In September 2009, the intensive glucose control protocol in ACS patients was modified to reflect emerging data on glucose management in the ICU. From this point forward, patients with an admission blood glucose >180 mg/dL received intravenous insulin infusion to achieve a target blood glucose 100-140 mg/dL.
1032356|NCT00736229|B1|Baseline|Exenatide|Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.
1032357|NCT00736229|P3|Participant Flow|Intensive|In 2008, the Mid America Heart and Vascular Institute implemented an intensive glucose control protocol using IV insulin in critically ill hyperglycemic patients hospitalized with ACS. All patients admitted with blood glucose ≥140 mg/dL received intravenous insulin infusion to achieve a target blood glucose 90-120 mg/dL. The efficacy of this protocol has been studied compared to ACS patients with admission blood glucose >140 mg/dL admitted prior to protocol implementation.
1032358|NCT00736229|P2|Participant Flow|Moderate|In September 2009, the intensive glucose control protocol in ACS patients was modified to reflect emerging data on glucose management in the ICU. From this point forward, patients with an admission blood glucose >180 mg/dL received intravenous insulin infusion to achieve a target blood glucose 100-140 mg/dL.
1032359|NCT00736229|P1|Participant Flow|Exenatide|Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.
1032360|NCT00736229|O1|Outcome|Exenatide|Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.
1032361|NCT00736229|O3|Outcome|Intensive|In 2008, the Mid America Heart and Vascular Institute implemented an intensive glucose control protocol using IV insulin in critically ill hyperglycemic patients hospitalized with ACS. All patients admitted with blood glucose ≥140 mg/dL received intravenous insulin infusion to achieve a target blood glucose 90-120 mg/dL. The efficacy of this protocol has been studied compared to ACS patients with admission blood glucose >140 mg/dL admitted prior to protocol implementation.
1032362|NCT00736229|O2|Outcome|Moderate|In September 2009, the intensive glucose control protocol in ACS patients was modified to reflect emerging data on glucose management in the ICU. From this point forward, patients with an admission blood glucose >180 mg/dL received intravenous insulin infusion to achieve a target blood glucose 100-140 mg/dL.
1032363|NCT00736229|O1|Outcome|Exenatide|Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.
1032364|NCT00736229|O3|Outcome|Intensive|In 2008, the Mid America Heart and Vascular Institute implemented an intensive glucose control protocol using IV insulin in critically ill hyperglycemic patients hospitalized with ACS. All patients admitted with blood glucose ≥140 mg/dL received intravenous insulin infusion to achieve a target blood glucose 90-120 mg/dL. The efficacy of this protocol has been studied compared to ACS patients with admission blood glucose >140 mg/dL admitted prior to protocol implementation.
1032365|NCT00736229|O2|Outcome|Moderate|In September 2009, the intensive glucose control protocol in ACS patients was modified to reflect emerging data on glucose management in the ICU. From this point forward, patients with an admission blood glucose >180 mg/dL received intravenous insulin infusion to achieve a target blood glucose 100-140 mg/dL.
1032366|NCT00736229|O1|Outcome|Exenatide|Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.
1032367|NCT00736229|O3|Outcome|Intensive|In 2008, the Mid America Heart and Vascular Institute implemented an intensive glucose control protocol using IV insulin in critically ill hyperglycemic patients hospitalized with ACS. All patients admitted with blood glucose ≥140 mg/dL received intravenous insulin infusion to achieve a target blood glucose 90-120 mg/dL. The efficacy of this protocol has been studied compared to ACS patients with admission blood glucose >140 mg/dL admitted prior to protocol implementation. These data came from a medical record review and the retrospective data collection and analysis were approved by the Saint Luke's Hospital Institutional Review Board.
1032368|NCT00736229|O2|Outcome|Moderate|In September 2009, the intensive glucose control protocol in acute coronary syndrome (ACS) patients was modified to reflect emerging data on glucose management in the ICU. From this point forward, all patients with an admission blood glucose >180 mg/dL received intravenous insulin infusion to achieve a target blood glucose 100-140 mg/dL. These data came from a medical record review and the retrospective data collection and analysis were approved by the Saint Luke's Hospital Institutional Review Board.
1032369|NCT00736229|O1|Outcome|Exenatide|Patients with admission blood glucose values of 140-400 mg/dL admitted to the coronary intensive care unit were eligible. Patients that provided consent were intravenously infused with Exenatide as a 0.05 mcg/min bolus for 30 minutes followed by a fixed 0.025 mcg/min dose for up to 48 hours. Blood glucose values were measured hourly following commencement of infusion.
1032370|NCT00736229|E1|Reported Event|Exenatide|Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.
1032371|NCT00736190|B1|Baseline|A: TDF|Tenofovir disoproxil fumarate 300 mg by mouth daily
1032372|NCT00736190|P1|Participant Flow|A: TDF|Tenofovir disoproxil fumarate (TDF) 300 mg by mouth daily
1032373|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
1032374|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
1032375|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
1032377|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
1032378|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
1032379|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
1032380|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
1032381|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
1032382|NCT00736190|O1|Outcome|Tenofovir DF|300-mg tablet (marketed formulation) taken orally once daily
1032383|NCT00736190|E1|Reported Event|A: TDF|Tenofovir disoproxil fumarate 300 mg by mouth daily
1032384|NCT00736125|B3|Baseline|Total|Total of all reporting groups
1032385|NCT00736125|B2|Baseline|2 Carbon Dioxide Lavage|carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
1032386|NCT00736125|B1|Baseline|1 Pulsatile Saline Lavage|pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
1032387|NCT00736125|P2|Participant Flow|2 Carbon Dioxide Lavage|carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
1032388|NCT00736125|P1|Participant Flow|1 Pulsatile Saline Lavage|pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
1032389|NCT00736125|O2|Outcome|2 Carbon Dioxide Lavage|carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
1032390|NCT00736125|O1|Outcome|1 Pulsatile Saline Lavage|pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
1032391|NCT00736125|O2|Outcome|2 Carbon Dioxide Lavage|carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
1032392|NCT00736125|O1|Outcome|1 Pulsatile Saline Lavage|pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
1032393|NCT00736125|E2|Reported Event|2 Carbon Dioxide Lavage|carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
1032394|NCT00736125|E1|Reported Event|1 Pulsatile Saline Lavage|pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
1032395|NCT00736099|B3|Baseline|Total|Total of all reporting groups
1032396|NCT00736099|B2|Baseline|New Lina|Patients pre-treated with placebo
1032397|NCT00736099|B1|Baseline|Old Lina|Patients pre-treated with linagliptin
1032398|NCT00736099|P2|Participant Flow|New Lina|Patients pre-treated with placebo
1032399|NCT00736099|P1|Participant Flow|Old Lina|Patients pre-treated with linagliptin (BI 1356)
1032400|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032401|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032402|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032403|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032404|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032405|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032406|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032407|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032408|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032409|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032410|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032411|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032412|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032413|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032414|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032415|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032416|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032417|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032418|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032419|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032420|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032421|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032422|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032423|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032424|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032425|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032426|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032427|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032428|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032429|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032430|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032431|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032432|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032433|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032434|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032435|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032436|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032437|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032438|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032439|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032440|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032441|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032442|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032443|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032445|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032446|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032447|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032448|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032449|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032451|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032452|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032453|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032454|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032455|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032456|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032457|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032458|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032459|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032460|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032461|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032462|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032463|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032464|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032465|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032466|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032467|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032468|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032469|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032470|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032471|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032472|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032473|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032474|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032475|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032476|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032477|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032478|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032479|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032480|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032481|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032482|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032483|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032484|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032485|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032486|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032487|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032488|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032489|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032490|NCT00736099|O2|Outcome|New Lina|Patients pre-treated with placebo
1032491|NCT00736099|O1|Outcome|Old Lina|Patients pre-treated with linagliptin
1032492|NCT00736099|E2|Reported Event|New Lina|Patients pre-treated with placebo
1032493|NCT00736099|E1|Reported Event|Old Lina|Patients pre-treated with linagliptin
1032494|NCT00736073|B3|Baseline|Total|Total of all reporting groups
1032495|NCT00736073|B2|Baseline|Arm 2-Randomized to Placebo|"Placebo~Placebo : one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
1032496|NCT00736073|B1|Baseline|Arm 1-medication Pre and Post Procedure|"aprepitant~aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
1032497|NCT00736073|P2|Participant Flow|Arm 2-Randomized to Placebo|"Placebo~Placebo : one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
1032498|NCT00736073|P1|Participant Flow|Arm 1-medication Pre and Post Procedure|"Aprepitant~aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
1032499|NCT00736073|O2|Outcome|Arm 2-Randomized to Placebo|"Placebo~Placebo : one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
1032500|NCT00736073|O1|Outcome|Arm 1-medication Pre and Post Procedure|"Aprepitant~aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
1032501|NCT00736073|O2|Outcome|Arm 2-Randomized to Placebo|"Placebo~Placebo : one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
1032502|NCT00736073|O1|Outcome|Arm 1-medication Pre and Post Procedure|"Aprepitant~aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
1032503|NCT00736073|O2|Outcome|Arm 2-Randomized to Placebo|"Placebo~Placebo : one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
1032504|NCT00736073|O1|Outcome|Arm 1-medication Pre and Post Procedure|"aprepitant~aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
1032505|NCT00736073|E2|Reported Event|Arm 2-Randomized to Placebo|"Placebo~Placebo : one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
1032506|NCT00736073|E1|Reported Event|Arm 1-medication Pre and Post Procedure|"aprepitant~aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose"
1033097|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
1032507|NCT00736034|B1|Baseline|PS-Omega3|Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals
1032508|NCT00736034|P1|Participant Flow|PS-Omega3|Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals
1032509|NCT00736034|O1|Outcome|PS-Omega3|Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals
1032510|NCT00736034|E1|Reported Event|PS-Omega3|Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals
1032511|NCT00735969|B1|Baseline|Peginterferon and Ribavirin Arm|Patients 18 years of age and older with chronic hepatitis C genotype 1 who have not been successfully treated with a standard course of Peginterferon and ribavirin are screened and randomly assigned to receive either standard treatment with Peginterferon and ribavirin or to receive Peginterferon plus twice the dose of ribavirin (2,000 to 2,400 mg daily) for 48 weeks.
1032512|NCT00735969|P1|Participant Flow|Peginterferon and Ribavirin Arm|Patients 18 years of age and older with chronic hepatitis C genotype 1 who have not been successfully treated with a standard course of Peginterferon and ribavirin are screened and assigned to receive Peginterferon plus twice the dose of ribavirin (2,000 to 2,400 mg daily) for 48 weeks.
1032513|NCT00735969|O1|Outcome|Peginterferon and Ribavirin Arm|Patients 18 years of age and older with chronic hepatitis C genotype 1 who have not been successfully treated with a standard course of Peginterferon and ribavirin are screened and randomly assigned to receive either standard treatment with Peginterferon and ribavirin or to receive Peginterferon plus twice the dose of ribavirin (2,000 to 2,400 mg daily) for 48 weeks.
1032514|NCT00735969|E1|Reported Event|Peginterferon and Ribavirin Arm|Patients 18 years of age and older with chronic hepatitis C genotype 1 who have not been successfully treated with a standard course of Peginterferon and ribavirin are screened and randomly assigned to receive either standard treatment with Peginterferon and ribavirin or to receive Peginterferon plus twice the dose of ribavirin (2,000 to 2,400 mg daily) for 48 weeks.
1032515|NCT00735943|B1|Baseline|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
1032516|NCT00735943|P1|Participant Flow|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
1032517|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
1032518|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
1032519|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
1032520|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
1032521|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
1032522|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
1032523|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
1032524|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
1032525|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
1032526|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
1032527|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
1032528|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
1032529|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
1032530|NCT00735943|O1|Outcome|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
1032531|NCT00735943|E1|Reported Event|Pegaptanib|Macugen 0.3 mg (pegaptanib sodium) administered once every 6 weeks by intravitreal injection into the study eye.
1032532|NCT00735917|B1|Baseline|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
1032533|NCT00735917|P1|Participant Flow|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
1032534|NCT00735917|O1|Outcome|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
1032535|NCT00735917|O1|Outcome|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
1032536|NCT00735917|O1|Outcome|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
1032537|NCT00735917|O1|Outcome|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
1032538|NCT00735917|O1|Outcome|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
1032539|NCT00735917|E1|Reported Event|Treatment (Saracatinib)|Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
1032569|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
1032540|NCT00735904|B1|Baseline|Axitinib + Cisplatin + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
1083565|NCT00606580|B4|Baseline|Total|Total of all reporting groups
1032541|NCT00735904|P1|Participant Flow|Axitinib + Cisplatin + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
1032542|NCT00735904|O1|Outcome|Axitinib + Cisplatin + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
1032543|NCT00735904|O1|Outcome|Axitinib + Cisplatin + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
1032544|NCT00735904|O1|Outcome|Axitinib + Cisplatin + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
1032545|NCT00735904|O1|Outcome|Axitinib + Cisplatin + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
1032546|NCT00735904|E1|Reported Event|Axitinib + Cisplatin + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.
1032547|NCT00735839|B3|Baseline|Total|Total of all reporting groups
1032548|NCT00735839|B2|Baseline|Placebo|Placebo single dose on Day 1
1032549|NCT00735839|B1|Baseline|V710|V710 vaccination (60 mcg) single dose on Day 1
1032550|NCT00735839|P2|Participant Flow|Placebo|Placebo single dose on Day 1
1032551|NCT00735839|P1|Participant Flow|V710|V710 vaccination (60 mcg) single dose on Day 1
1032552|NCT00735839|O2|Outcome|Placebo|Placebo single dose on Day 1
1032553|NCT00735839|O1|Outcome|V710|V710 vaccination (60 mcg) single dose on Day 1
1032554|NCT00735839|O2|Outcome|Placebo|Placebo single dose on Day 1
1032555|NCT00735839|O1|Outcome|V710|V710 vaccination (60 mcg) single dose on Day 1
1032556|NCT00735839|E2|Reported Event|Placebo|Placebo single dose on Day 1
1032557|NCT00735839|E1|Reported Event|V710|V710 vaccination (60 mcg) single dose on Day 1
1032558|NCT00735787|B3|Baseline|Total|Total of all reporting groups
1032559|NCT00735787|B2|Baseline|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
1032560|NCT00735787|B1|Baseline|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
1032561|NCT00735787|P2|Participant Flow|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
1032562|NCT00735787|P1|Participant Flow|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
1032563|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
1032564|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
1032565|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
1032566|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
1032567|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
1032568|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
1032649|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1032570|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
1032571|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
1032572|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
1032573|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
1032574|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
1032575|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
1032576|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
1032577|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
1032578|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
1032579|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
1032580|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
1032581|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
1032582|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
1032583|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
1032584|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
1032585|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
1032586|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
1032587|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
1032588|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
1032589|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
1032590|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
1032591|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
1032592|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
1032593|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
1032594|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
1032595|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
1032596|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
1032597|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
1032598|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
1032599|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
1032600|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
1032601|NCT00735787|O2|Outcome|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
1032602|NCT00735787|O1|Outcome|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
1032603|NCT00735787|E2|Reported Event|Adalimumab|80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
1032604|NCT00735787|E1|Reported Event|Placebo/Adalimumab|Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
1032605|NCT00735709|B5|Baseline|Total|Total of all reporting groups
1032606|NCT00735709|B4|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032607|NCT00735709|B3|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032608|NCT00735709|B2|Baseline|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032609|NCT00735709|B1|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1032610|NCT00735709|P4|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032611|NCT00735709|P3|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032612|NCT00735709|P2|Participant Flow|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032613|NCT00735709|P1|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1032614|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032615|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032616|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032617|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1032618|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032619|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032620|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032621|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1032622|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032623|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032624|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032625|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1032626|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032627|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032628|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032629|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1032630|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032631|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032632|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032633|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1032634|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032635|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032636|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032637|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1032638|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032639|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032640|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032641|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1032642|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032643|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032644|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032645|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1032646|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032647|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032648|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032650|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032651|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032652|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032653|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1032654|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032655|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032656|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032657|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1032658|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032659|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032660|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032661|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1032662|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032663|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032664|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032665|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1032666|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032667|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032668|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032669|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1032670|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032671|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032672|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032673|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1032674|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032675|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032676|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032677|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1032678|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032679|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032680|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032681|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1032682|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032683|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032684|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032685|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1032686|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032687|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032688|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032689|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1032690|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032691|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032692|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032693|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1032694|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032695|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032696|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032697|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1032698|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032699|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032700|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032701|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1032702|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032703|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032704|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032705|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1032706|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032707|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032708|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032709|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1032710|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032711|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032712|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032713|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1032714|NCT00735709|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032715|NCT00735709|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032716|NCT00735709|O2|Outcome|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032717|NCT00735709|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1032718|NCT00735709|E4|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032719|NCT00735709|E3|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032720|NCT00735709|E2|Reported Event|Vortioxetine 1 mg|Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.
1032721|NCT00735709|E1|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1032722|NCT00735696|B1|Baseline|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants will receive ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants will continue to receive ramucirumab monotherapy every 3 weeks, provided there is ongoing evidence of benefit upon review every 6 weeks."
1032723|NCT00735696|P1|Participant Flow|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
1032724|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
1032725|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
1032726|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
1032727|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
1032741|NCT00735670|O2|Outcome|Placebo|Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
1032780|NCT00735644|O1|Outcome|JE CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously
1032781|NCT00735644|O5|Outcome|Hepatitis A|Participants 12 to 18 months of age received Hepatitis A vaccine
1032728|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
1032729|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
1032730|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
1032731|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
1032732|NCT00735696|O1|Outcome|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
1032733|NCT00735696|E1|Reported Event|Ramucirumab + Paclitaxel + Carboplatin|"ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.~paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.~carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.~Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks."
1032734|NCT00735670|B3|Baseline|Total|Total of all reporting groups
1032735|NCT00735670|B2|Baseline|Placebo|Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
1032736|NCT00735670|B1|Baseline|Venlafaxine|Venlafaxine HCl is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) and has been approved by the FDA for the treatment of major depressive disorder. The treatment group will receive a sub-therapeutic dose over a two week period, with a two week titration, starting at 37.5 mg up to a maximum dose of 150 mg per day. At the end of the treatment period, dosage was tapered down in a step-wise fashion over a period of three weeks; 75 mg. for two weeks and 37.5 mg. for one week. While this was the standard protocol, study drug tapering was individualized based on side effects and the clinical judgment of the prescriber.
1032737|NCT00735670|P2|Participant Flow|Placebo|Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
1032738|NCT00735670|P1|Participant Flow|Venlafaxine|Venlafaxine HCl is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) and has been approved by the FDA for the treatment of major depressive disorder. The treatment group will receive a sub-therapeutic dose over a two week period, with a two week titration, starting at 37.5 mg up to a maximum dose of 150 mg per day. At the end of the treatment period, dosage was tapered down in a step-wise fashion over a period of three weeks; 75 mg. for two weeks and 37.5 mg. for one week. While this was the standard protocol, study drug tapering was individualized based on side effects and the clinical judgment of the prescriber.
1032739|NCT00735670|O2|Outcome|Placebo|Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
1032740|NCT00735670|O1|Outcome|Venlafaxine|Venlafaxine HCl is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) and has been approved by the FDA for the treatment of major depressive disorder. The treatment group will receive a sub-therapeutic dose over a two week period, with a two week titration, starting at 37.5 mg up to a maximum dose of 150 mg per day. At the end of the treatment period, dosage was tapered down in a step-wise fashion over a period of three weeks; 75 mg. for two weeks and 37.5 mg. for one week. While this was the standard protocol, study drug tapering was individualized based on side effects and the clinical judgment of the prescriber.
1032779|NCT00735644|O2|Outcome|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
1032742|NCT00735670|O1|Outcome|Venlafaxine|Venlafaxine HCl is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) and has been approved by the FDA for the treatment of major depressive disorder. The treatment group will receive a sub-therapeutic dose over a two week period, with a two week titration, starting at 37.5 mg up to a maximum dose of 150 mg per day. At the end of the treatment period, dosage was tapered down in a step-wise fashion over a period of three weeks; 75 mg. for two weeks and 37.5 mg. for one week. While this was the standard protocol, study drug tapering was individualized based on side effects and the clinical judgment of the prescriber.
1032743|NCT00735670|E2|Reported Event|Placebo|Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
1032744|NCT00735670|E1|Reported Event|Venlafaxine|Venlafaxine HCl is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) and has been approved by the FDA for the treatment of major depressive disorder. The treatment group will receive a sub-therapeutic dose over a two week period, with a two week titration, starting at 37.5 mg up to a maximum dose of 150 mg per day. At the end of the treatment period, dosage was tapered down in a step-wise fashion over a period of three weeks; 75 mg. for two weeks and 37.5 mg. for one week. While this was the standard protocol, study drug tapering was individualized based on side effects and the clinical judgment of the prescriber.
1032745|NCT00735644|B6|Baseline|Total|Total of all reporting groups
1032746|NCT00735644|B5|Baseline|Hepatitis A|Participants 12 to 18 months of age received Hepatitis A vaccine
1032747|NCT00735644|B4|Baseline|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
1032748|NCT00735644|B3|Baseline|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
1032749|NCT00735644|B2|Baseline|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
1032750|NCT00735644|B1|Baseline|JE CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously
1032751|NCT00735644|P5|Participant Flow|Hepatitis A|Participants 12 to 18 months of age received the Hepatitis A vaccine
1032752|NCT00735644|P4|Participant Flow|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
1032753|NCT00735644|P3|Participant Flow|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE- CV from GPO MBP Lot 3
1032754|NCT00735644|P2|Participant Flow|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
1032755|NCT00735644|P1|Participant Flow|JE-CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO-MBP) Lot 1.
1032756|NCT00735644|O5|Outcome|Hepatitis A|Participants 12 to 18 months of age received Hepatitis A vaccine
1032757|NCT00735644|O4|Outcome|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
1032758|NCT00735644|O3|Outcome|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
1032759|NCT00735644|O2|Outcome|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
1032760|NCT00735644|O1|Outcome|JE-CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1
1032761|NCT00735644|O5|Outcome|Hepatitis A|Participants 12 to 18 months of age received Hepatitis A vaccine
1032762|NCT00735644|O4|Outcome|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
1032763|NCT00735644|O3|Outcome|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
1032764|NCT00735644|O2|Outcome|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
1032765|NCT00735644|O1|Outcome|JE CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously
1032766|NCT00735644|O5|Outcome|Hepatitis A|Participants 12 to 18 months of age received the Hepatitis vaccine intramuscularly
1032767|NCT00735644|O4|Outcome|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE CV from Acambis at WRAIR subcutaneously
1032768|NCT00735644|O3|Outcome|JE-CV MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE CV from GPO MBP Lot 3 subcutaneously
1032769|NCT00735644|O2|Outcome|JE-CV MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE CV from GPO MBP Lot 2 subcutaneously
1032770|NCT00735644|O1|Outcome|JE-CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously
1032771|NCT00735644|O5|Outcome|Hepatitis A|Participants 12 to 18 months of age received Hepatitis A vaccine
1032772|NCT00735644|O4|Outcome|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
1032773|NCT00735644|O3|Outcome|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
1032774|NCT00735644|O2|Outcome|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
1032775|NCT00735644|O1|Outcome|JE-CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1
1032776|NCT00735644|O5|Outcome|Hepatitis A|Participants 12 to 18 months of age received Hepatitis A vaccine
1032777|NCT00735644|O4|Outcome|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
1032778|NCT00735644|O3|Outcome|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
1032896|NCT00735371|O4|Outcome|Placebo|Placebo
1032782|NCT00735644|O4|Outcome|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
1032783|NCT00735644|O3|Outcome|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
1032784|NCT00735644|O2|Outcome|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
1032785|NCT00735644|O1|Outcome|JE CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1 subcutaneously
1032786|NCT00735644|E5|Reported Event|Hepatitis A|Participants 12 to 18 months of age received Hepatitis A vaccine
1032787|NCT00735644|E4|Reported Event|JE-CV WRAIR|Participants 12 to 18 months of age received one dose of JE-CV from Acambis at Walter Reed Army Institute of Research (WRAIR)
1032788|NCT00735644|E3|Reported Event|JE-CV GPO MBP (Lot 3)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 3
1032789|NCT00735644|E2|Reported Event|JE-CV GPO MBP (Lot 2)|Participants 12 to 18 months of age received one dose of JE-CV from GPO MBP Lot 2
1032790|NCT00735644|E1|Reported Event|JE-CV GPO MBP (Lot 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) from Government Pharmaceutical Organization Mérieux Biological Products (GPO MBP) Lot 1
1032791|NCT00735618|B1|Baseline|Guided Relaxation|Heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program
1032792|NCT00735618|P1|Participant Flow|Guided Relaxation|Heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program
1032793|NCT00735618|O1|Outcome|Guided Relaxation|Heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program and summed ESAS scores
1032794|NCT00735618|E1|Reported Event|Guided Relaxation|Heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program
1032795|NCT00735553|B4|Baseline|Total|Total of all reporting groups
1032796|NCT00735553|B3|Baseline|Placebo|"oral daily dose of placebo~Placebo: Two placebo capsules orally daily for up to four months"
1032797|NCT00735553|B2|Baseline|50 mg Proellex|"50 mg oral daily dose of Proellex~Proellex: Two 25 mg mg capsules of Proellex® orally daily for up to four months"
1032798|NCT00735553|B1|Baseline|25 mg Proellex|"25 mg oral daily dose of Proellex~Proellex: One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months"
1032799|NCT00735553|P1|Participant Flow|All Groups|25 mg, 50 mg oral daily dose of Proellex or placebo
1032800|NCT00735553|O3|Outcome|Placebo|"oral daily dose of placebo~Placebo: Two placebo capsules orally daily for up to four months"
1032801|NCT00735553|O2|Outcome|50 mg Proellex|"50 mg oral daily dose of Proellex~Proellex: Two 25 mg mg capsules of Proellex® orally daily for up to four months"
1032802|NCT00735553|O1|Outcome|25 mg Proellex|"25 mg oral daily dose of Proellex~Proellex: One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months"
1032803|NCT00735553|E3|Reported Event|Placebo|"oral daily dose of placebo~Placebo: Two placebo capsules orally daily for up to four months"
1032804|NCT00735553|E2|Reported Event|50 mg Proellex|"50 mg oral daily dose of Proellex~Proellex: Two 25 mg mg capsules of Proellex® orally daily for up to four months"
1032805|NCT00735553|E1|Reported Event|25 mg Proellex|"25 mg oral daily dose of Proellex~Proellex: One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months"
1032806|NCT00735475|B3|Baseline|Total|Total of all reporting groups
1032807|NCT00735475|B2|Baseline|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
1032808|NCT00735475|B1|Baseline|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
1032809|NCT00735475|P2|Participant Flow|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
1032810|NCT00735475|P1|Participant Flow|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
1032811|NCT00735475|O2|Outcome|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
1032812|NCT00735475|O1|Outcome|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
1032813|NCT00735475|O2|Outcome|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
1032814|NCT00735475|O1|Outcome|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
1032815|NCT00735475|O2|Outcome|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
1032816|NCT00735475|O1|Outcome|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
1032817|NCT00735475|O2|Outcome|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
1032818|NCT00735475|O1|Outcome|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
1032819|NCT00735475|O2|Outcome|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
1032820|NCT00735475|O1|Outcome|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
1032821|NCT00735475|O2|Outcome|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
1032822|NCT00735475|O1|Outcome|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
1032823|NCT00735475|O2|Outcome|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
1032824|NCT00735475|O1|Outcome|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
1032825|NCT00735475|E2|Reported Event|Fluzone® Group|Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
1084263|NCT00605085|P1|Participant Flow|IC51|IC51
1032826|NCT00735475|E1|Reported Event|Afluria® Group|Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.
1032827|NCT00735462|B4|Baseline|Total|Total of all reporting groups
1032828|NCT00735462|B3|Baseline|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks.
1032829|NCT00735462|B2|Baseline|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.
1032830|NCT00735462|B1|Baseline|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.
1032831|NCT00735462|P3|Participant Flow|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks.
1032832|NCT00735462|P2|Participant Flow|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.
1032833|NCT00735462|P1|Participant Flow|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.
1032834|NCT00735462|O3|Outcome|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks.
1032835|NCT00735462|O2|Outcome|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.
1032836|NCT00735462|O1|Outcome|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.
1032837|NCT00735462|O3|Outcome|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks.
1032838|NCT00735462|O2|Outcome|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.
1032839|NCT00735462|O1|Outcome|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.
1032840|NCT00735462|E3|Reported Event|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks.
1032841|NCT00735462|E2|Reported Event|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks.
1032842|NCT00735462|E1|Reported Event|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks.
1032843|NCT00735449|B3|Baseline|Total|Total of all reporting groups
1032844|NCT00735449|B2|Baseline|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
1032845|NCT00735449|B1|Baseline|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
1032846|NCT00735449|P2|Participant Flow|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
1032847|NCT00735449|P1|Participant Flow|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
1032848|NCT00735449|O2|Outcome|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
1032849|NCT00735449|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
1032850|NCT00735449|O2|Outcome|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
1032851|NCT00735449|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
1032852|NCT00735449|O2|Outcome|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
1032853|NCT00735449|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
1032854|NCT00735449|O2|Outcome|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
1032855|NCT00735449|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
1032856|NCT00735449|O2|Outcome|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
1032857|NCT00735449|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
1032858|NCT00735449|E2|Reported Event|Timolol Maleate 0.5%|Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
1032859|NCT00735449|E1|Reported Event|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)
1032860|NCT00735436|B1|Baseline|Gliadel/Avastin/CPT-11|Gliadel/Avastin/CPT-11
1032861|NCT00735436|P1|Participant Flow|Gliadel/Avastin/CPT-11|Gliadel wafers (1-8) inserted at time of gross total resection. CPT-11 (Irinotecan): 125 mg/m2 (no enzyme-inducing anticonvulsant drugs) or 340 mg/m2 (enzyme-inducing anticonvulsant drugs) given every two weeks on days 1, 15, 29 of each 42 day cycle, up to 12 cycles. If the patient has the uridine diphosphate (UDP) glucuronosyltransferase 1 family, polypeptide A1 (UGT1A1) polymorphism (7/7), they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. For patients on an enzyme-inducing anti-epileptic drugs (EIAED), the starting dose will be 275 mg/M2, and for patients not on an EIAED, the starting dose will be 75 mg/M2. Avastin: 10 mg/kg immediately after the irinotecan given every 2 weeks on days 1, 15, 29 of each 42 day cycle.
1032862|NCT00735436|O1|Outcome|Gliadel/Avastin/CPT-11|Gliadel/Avastin/CPT-11
1032863|NCT00735436|O1|Outcome|Gliadel/Avastin/CPT-11|Gliadel/Avastin/CPT-11
1032864|NCT00735436|O1|Outcome|Gliadel/Avastin/CPT-11|Gliadel wafers (1-8) inserted at time of gross total resection. CPT-11 (Irinotecan): 125 mg/m2 (no enzyme-inducing anticonvulsant drugs) or 340 mg/m2 (enzyme-inducing anticonvulsant drugs) given every two weeks on days 1, 15, 29 of each 42 day cycle, up to 12 cycles. If the patient has the UGT 1A1 polymorphism (7/7), they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. For patients on an EIAED, the starting dose will be 275 mg/M2, and for patients not on an EIAED, the starting dose will be 75 mg/M2. Avastin: 10 mg/kg immediately after the irinotecan given every 2 weeks on days 1, 15, 29 of each 42 day cycle.
1032897|NCT00735371|O3|Outcome|LDX 70 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
1034379|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
1032898|NCT00735371|O2|Outcome|LDX 50 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
1032865|NCT00735436|O1|Outcome|Gliadel/Avastin/CPT-11|Gliadel wafers (1-8) inserted at time of gross total resection. CPT-11 (Irinotecan): 125 mg/m2 (no enzyme-inducing anticonvulsant drugs) or 340 mg/m2 (enzyme-inducing anticonvulsant drugs) given every two weeks on days 1, 15, 29 of each 42 day cycle, up to 12 cycles. If the patient has the UGT 1A1 polymorphism (7/7), they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. For patients on an EIAED, the starting dose will be 275 mg/M2, and for patients not on an EIAED, the starting dose will be 75 mg/M2. Avastin: 10 mg/kg immediately after the irinotecan given every 2 weeks on days 1, 15, 29 of each 42 day cycle.
1032866|NCT00735436|O1|Outcome|Gliadel/Avastin/CPT-11|Gliadel/Avastin/CPT-11
1032867|NCT00735436|O1|Outcome|Gliadel/Avastin/CPT-11|Gliadel/Avastin/CPT-11
1032868|NCT00735436|E1|Reported Event|Gliadel/Avastin/CPT-11|Gliadel/Avastin/CPT-11
1032869|NCT00735397|B1|Baseline|Perampanel|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
1032870|NCT00735397|P1|Participant Flow|Perampanel|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
1032871|NCT00735397|O3|Outcome|Secondarily Generalized Seizures|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
1032872|NCT00735397|O2|Outcome|Complex Partial Plus Secondarily Generalized Seizures|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
1032873|NCT00735397|O1|Outcome|Overall|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
1032874|NCT00735397|O3|Outcome|Secondarily Generalized Seizures|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
1032875|NCT00735397|O2|Outcome|Complex Partial Plus Secondarily Generalized Seizures|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
1032876|NCT00735397|O1|Outcome|Overall|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
1032877|NCT00735397|O1|Outcome|Perampanel|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
1032878|NCT00735397|E1|Reported Event|Perampanel|Participants previously receiving perampanel/placebo in the DB study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study up to approximately 5 years.
1032879|NCT00735371|B5|Baseline|Total|Total of all reporting groups
1032880|NCT00735371|B4|Baseline|Placebo|Placebo
1032881|NCT00735371|B3|Baseline|LDX 70 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
1032882|NCT00735371|B2|Baseline|LDX 50 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
1032883|NCT00735371|B1|Baseline|Lisdexamfetamine Dimesylate (LDX) 30 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
1032884|NCT00735371|P4|Participant Flow|Placebo|Placebo
1032885|NCT00735371|P3|Participant Flow|LDX 70 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
1032886|NCT00735371|P2|Participant Flow|LDX 50 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
1032887|NCT00735371|P1|Participant Flow|Lisdexamfetamine Dimesylate (LDX) 30 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
1032888|NCT00735371|O4|Outcome|Placebo|Placebo
1032889|NCT00735371|O3|Outcome|LDX 70 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
1032890|NCT00735371|O2|Outcome|LDX 50 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
1032891|NCT00735371|O1|Outcome|Lisdexamfetamine Dimesylate (LDX) 30 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
1032892|NCT00735371|O4|Outcome|Placebo|Placebo
1032893|NCT00735371|O3|Outcome|LDX 70 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
1032894|NCT00735371|O2|Outcome|LDX 50 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
1032895|NCT00735371|O1|Outcome|Lisdexamfetamine Dimesylate (LDX) 30 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
1032899|NCT00735371|O1|Outcome|Lisdexamfetamine Dimesylate (LDX) 30 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
1032900|NCT00735371|E4|Reported Event|Placebo|Placebo
1032901|NCT00735371|E3|Reported Event|LDX 70 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
1032902|NCT00735371|E2|Reported Event|LDX 50 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
1032903|NCT00735371|E1|Reported Event|Lisdexamfetamine Dimesylate (LDX) 30 mg|Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
1032904|NCT00735306|B1|Baseline|Chemoradiation|Avastin 10 mg/kg intravenous infusion day 1, 15 and 29 and Tarceva 100, 125 or 150 mg once daily by mouth and Radiation Therapy Mon-Fri for 28 treatments.
1032905|NCT00735306|P1|Participant Flow|Chemoradiation|Avastin 10 mg/kg intravenous infusion day 1, 15 and 29 and Tarceva 100, 125 or 150 mg once daily by mouth and Radiation Therapy Mon-Fri for 28 treatments.
1032906|NCT00735306|O1|Outcome|Single Arm Avastin, Tarceva and Radiation Therapy|"Avastin, Tarceva and Radiation Therapy~Avastin: Avastin 10 mg/kg IV on days 1, 15 and 29 Begins the first day of radiation therapy~Tarceva: Daily by mouth per assigned dose, for 5.5 weeks Begins the first day of radiation therapy~Radiation Therapy: Radiation to the pancreas Monday through Friday for 28 treatments"
1032907|NCT00735306|O1|Outcome|Chemoradiation|Avastin 10 mg/kg intravenous infusion day 1, 15 and 29 and Tarceva 100, 125 or 150 mg once daily by mouth and Radiation Therapy Mon-Fri for 28 treatments.
1032908|NCT00735306|O1|Outcome|Chemoradiation|Avastin 10 mg/kg intravenous infusion day 1, 15 and 29 and Tarceva 100, 125 or 150 mg once daily by mouth and Radiation Therapy Mon-Fri for 28 treatments.
1032909|NCT00735306|E1|Reported Event|Chemoradiation|Avastin 10 mg/kg intravenous infusion day 1, 15 and 29 and Tarceva 100, 125 or 150 mg once daily by mouth and Radiation Therapy Mon-Fri for 28 treatments.
1032910|NCT00735072|B3|Baseline|Total|Total of all reporting groups
1032911|NCT00735072|B2|Baseline|Placebo|Placebo (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
1032912|NCT00735072|B1|Baseline|Maraviroc|Maraviroc (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
1032913|NCT00735072|P2|Participant Flow|Placebo|Placebo (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
1032914|NCT00735072|P1|Participant Flow|Maraviroc|Maraviroc (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
1032915|NCT00735072|O2|Outcome|Placebo|Placebo (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
1032916|NCT00735072|O1|Outcome|Maraviroc|Maraviroc (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
1032917|NCT00735072|E2|Reported Event|Placebo|Placebo (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
1032918|NCT00735072|E1|Reported Event|Maraviroc|Maraviroc (dose based on current medications in regimen: 150mg PO BID for those on a protease inhibitor-based regimen other than Tipranavir; 600mg PO BID for efavirenz-containing regimens; or 300 mg PO BID for all other regimens).
1032919|NCT00735007|B1|Baseline|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
1032920|NCT00735007|P1|Participant Flow|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
1032921|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
1032922|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
1032923|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
1032924|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
1032925|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
1032926|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
1032927|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
1032928|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
1032929|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
1032930|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
1032931|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
1032932|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
1032933|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
1032934|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
1032935|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
1032936|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
1032937|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
1032938|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
1032939|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
1032940|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
1032941|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
1032942|NCT00735007|O1|Outcome|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
1032943|NCT00735007|E1|Reported Event|RebiSmart for Self-injection|Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
1032944|NCT00734994|B1|Baseline|Mitomycin C With Hyperthermia|Mitomycin C and Hyperthermia
1032945|NCT00734994|P1|Participant Flow|Mitomycin C With Hyperthermia and Recurrent Bladder Cancer|Mitomycin C with Hyperthermia to Treat Recurrent Bladder Cancer
1032946|NCT00734994|O1|Outcome|Mitomycin C With Hyperthermia|Mitomycin C and Hyperthermia
1032947|NCT00734994|O1|Outcome|Hyperthermia System, Mitomycin C|"Pilot study single arm study to test the safety, tolerability and clinical benefit of regional hyperthermia and mitomycin-C intravesical chemotherapy to treat non-invasive Transitional Cell carcinoma (TCC) of the bladder that has recurred after standard resection and adjuvant therapy.~Hyperthermia System: Hyperthermia applied to heat the bladder to a temperature of 42 degrees Celsius for 40-60 minutes concurrent with mitomycin Treatment Schedule: 6 Weekly Sessions (Induction) followed by 4 Monthly Sessions (Maintenance) until documented second recurrence~Mitomycin C: 40 mg in 40 ml sterile water instilled into bladder"
1032948|NCT00734994|E1|Reported Event|Mitomycin C With Hyperthermia|Mitomycin C and Hyperthermia
1032949|NCT00734968|B3|Baseline|Total|Total of all reporting groups
1032950|NCT00734968|B2|Baseline|Placebo|"Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)~Placebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets."
1032951|NCT00734968|B1|Baseline|Treatment|"Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively~Nitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence"
1032952|NCT00734968|P2|Participant Flow|Treatment|"Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively~Nitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence"
1032953|NCT00734968|P1|Participant Flow|Placebo|"Arm randomly assigned to receive placebo 1 tablet PO twice a day (BID) x 3 days post-operatively. The incidence of urinary tract infection (UTI) in this group will be compared with group one (1).~Placebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100 mg tablets."
1032954|NCT00734968|O2|Outcome|Placebo|"Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)~Placebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets."
1032955|NCT00734968|O1|Outcome|Treatment|"Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively~Nitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence"
1032956|NCT00734968|O2|Outcome|Placebo|"Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)~Placebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets."
1032957|NCT00734968|O1|Outcome|Treatment|"Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively~Nitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence"
1032958|NCT00734968|O2|Outcome|Placebo|"Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)~Placebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets."
1032959|NCT00734968|O1|Outcome|Treatment|"Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively~Nitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence"
1032960|NCT00734968|E2|Reported Event|Treatment|"Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively~Nitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence"
1032961|NCT00734968|E1|Reported Event|Placebo|"Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)~Placebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets."
1032962|NCT00734929|B3|Baseline|Total|Total of all reporting groups
1032963|NCT00734929|B2|Baseline|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
1032964|NCT00734929|B1|Baseline|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
1032965|NCT00734929|P2|Participant Flow|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
1032966|NCT00734929|P1|Participant Flow|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
1032967|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
1032968|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
1033051|NCT00734656|E2|Reported Event|Placebo Medication + 0.8 gr/kg Ethanol|placebo medication paired with active alcohol
1032969|NCT00734929|O2|Outcome|Ondansetron + Dexamethasone|"Ondansetron 4 mg within 30 min of the end of surgery + Dexamethasone 10 mg after induction of anesthesia~Ondansetron + Dexamethasone: Ondansetron 4 mg + Dexamethasone 10 mg"
1032970|NCT00734929|O1|Outcome|Aprepitant + Dexamethasone|"Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia~Aprepitant + Dexamethasone: Aprepitant 40 mg + Dexamethasone 10 mg"
1032971|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
1032972|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
1032973|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
1032974|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
1032975|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
1032976|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
1032977|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
1032978|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
1032979|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
1032980|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
1032981|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
1032982|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
1032983|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
1032984|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
1032985|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
1032986|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
1032987|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
1032988|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
1032989|NCT00734929|O2|Outcome|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
1032990|NCT00734929|O1|Outcome|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
1032991|NCT00734929|E2|Reported Event|Ondansetron|Ondansetron 4 mg within 30 minutes of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
1032992|NCT00734929|E1|Reported Event|Aprepitant|Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
1032993|NCT00734851|B1|Baseline|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
1032994|NCT00734851|P1|Participant Flow|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
1032995|NCT00734851|O1|Outcome|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
1032996|NCT00734851|O1|Outcome|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
1032997|NCT00734851|O1|Outcome|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
1032998|NCT00734851|O1|Outcome|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
1032999|NCT00734851|O1|Outcome|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
1033000|NCT00734851|O1|Outcome|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
1033001|NCT00734851|O1|Outcome|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
1033002|NCT00734851|E1|Reported Event|Multimodality|4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
1033003|NCT00734799|B3|Baseline|Total|Total of all reporting groups
1033004|NCT00734799|B2|Baseline|Intervention|Sleep Intervention for PTSD (SIP)
1033005|NCT00734799|B1|Baseline|Wait List|Usual Care/Wait-List Control
1033006|NCT00734799|P2|Participant Flow|Intervention|Sleep Intervention for PTSD (SIP)
1033007|NCT00734799|P1|Participant Flow|Wait List|Usual Care/Wait-List Control
1033008|NCT00734799|O2|Outcome|Intervention|Sleep Intervention for PTSD (SIP)
1033009|NCT00734799|O1|Outcome|Wait List|Usual Care/Wait-List Control
1033010|NCT00734799|O2|Outcome|Intervention|Sleep Intervention for PTSD (SIP)
1033011|NCT00734799|O1|Outcome|Wait List|Usual Care/Wait-List Control
1033012|NCT00734799|E2|Reported Event|Intervention|Sleep Intervention for PTSD (SIP)
1033013|NCT00734799|E1|Reported Event|Wait List|Usual Care/Wait-List Control
1033050|NCT00734656|E3|Reported Event|4 mg Dutasteride + Placebo Alcohol|4 mg dutasteride paired with placebo alcohol
1033052|NCT00734656|E1|Reported Event|Placebo Medication + Placebo Alcohol|placebo medication paired with placebo alcohol
1033014|NCT00734747|B1|Baseline|Medigus SRS Endoscopic Stapling System|"Endoluminal fundoplication for the treatment of GERD~MediGus SRS endoscopic stapling system: The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location."
1033015|NCT00734747|P1|Participant Flow|Medigus SRS Endoscopic Stapling System|"Endoluminal fundoplication for the treatment of GERD~Medigus SRS endoscopic stapling system: The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location."
1033016|NCT00734747|O1|Outcome|Medigus SRS Endoscopic Stapling System|"Endoluminal fundoplication for the treatment of GERD~MediGus SRS endoscopic stapling system: The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location."
1033017|NCT00734747|O1|Outcome|Medigus SRS Endoscopic Stapling System|"Endoluminal fundoplication for the treatment of GERD~MediGus SRS endoscopic stapling system: The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location."
1033018|NCT00734747|O1|Outcome|Medigus SRS Endoscopic Stapling System|"Endoluminal fundoplication for the treatment of GERD~MediGus SRS endoscopic stapling system: The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location."
1033019|NCT00734747|O1|Outcome|Medigus SRS Endoscopic Stapling System|"Endoluminal fundoplication for the treatment of GERD~MediGus SRS endoscopic stapling system: The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location."
1033020|NCT00734747|E1|Reported Event|Medigus SRS Endoscopic Stapling System|"Endoluminal fundoplication for the treatment of GERD~MediGus SRS endoscopic stapling system: The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location."
1033021|NCT00734734|B1|Baseline|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
1033022|NCT00734734|P1|Participant Flow|FLUAD|Participants received a single intramuscular (IM) 0.5 milliliter (mL) dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
1033023|NCT00734734|O1|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 3.
1033024|NCT00734734|O1|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
1033025|NCT00734734|O1|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
1033026|NCT00734734|O1|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
1033027|NCT00734734|E1|Reported Event|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
1033028|NCT00734656|B1|Baseline|All Study Participants|All study participants enrolled in Lab Session 1
1033029|NCT00734656|P4|Participant Flow|4 mg Dutasteride + 0.8 mg/kg Ethanol|4 mg dutasteride paired with active alcohol
1033030|NCT00734656|P3|Participant Flow|4 mg Dutasteride + Placebo Alcohol|4 mg dutasteride paired with placebo alcohol
1033031|NCT00734656|P2|Participant Flow|Placebo Medication + 0.8 gr/kg Ethanol|placebo medication paired with active alcohol
1033032|NCT00734656|P1|Participant Flow|Placebo Medication + Placebo Alcohol|placebo medication paired with placebo alcohol
1033033|NCT00734656|O4|Outcome|4 mg Dutasteride + 0.8 mg/kg Ethanol|4 mg dutasteride paired with active alcohol
1033034|NCT00734656|O3|Outcome|4 mg Dutasteride + Placebo Alcohol|4 mg dutasteride paired with placebo alcohol
1033035|NCT00734656|O2|Outcome|Placebo Medication + 0.8 gr/kg Ethanol|placebo medication paired with active alcohol
1033036|NCT00734656|O1|Outcome|Placebo Medication + Placebo Alcohol|placebo medication paired with placebo alcohol
1033037|NCT00734656|O4|Outcome|4 mg Dutasteride + 0.8 mg/kg Ethanol|4 mg dutasteride paired with active alcohol
1033038|NCT00734656|O3|Outcome|4 mg Dutasteride + Placebo Alcohol|4 mg dutasteride paired with placebo alcohol
1033039|NCT00734656|O2|Outcome|Placebo Medication + 0.8 gr/kg Ethanol|placebo medication paired with active alcohol
1033040|NCT00734656|O1|Outcome|Placebo Medication + Placebo Alcohol|placebo medication paired with placebo alcohol
1033041|NCT00734656|O4|Outcome|4 mg Dutasteride + 0.8 mg/kg Ethanol|4 mg dutasteride paired with active alcohol
1033042|NCT00734656|O3|Outcome|4 mg Dutasteride + Placebo Alcohol|4 mg dutasteride paired with placebo alcohol
1033043|NCT00734656|O2|Outcome|Placebo Medication + 0.8 gr/kg Ethanol|placebo medication paired with active alcohol
1033044|NCT00734656|O1|Outcome|Placebo Medication + Placebo Alcohol|placebo medication paired with placebo alcohol
1033045|NCT00734656|O4|Outcome|4 mg Dutasteride + 0.8 mg/kg Ethanol|4 mg dutasteride paired with active alcohol
1033046|NCT00734656|O3|Outcome|4 mg Dutasteride + Placebo Alcohol|4 mg dutasteride paired with placebo alcohol
1033047|NCT00734656|O2|Outcome|Placebo Medication + 0.8 gr/kg Ethanol|placebo medication paired with active alcohol
1033048|NCT00734656|O1|Outcome|Placebo Medication + Placebo Alcohol|placebo medication paired with placebo alcohol
1033049|NCT00734656|E4|Reported Event|4 mg Dutasteride + 0.8 mg/kg Ethanol|4 mg dutasteride paired with active alcohol
1033054|NCT00734630|B2|Baseline|Placebo|Matching placebo tablets, oral administration
1033055|NCT00734630|B1|Baseline|Nebivolol|Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
1033056|NCT00734630|P2|Participant Flow|Placebo|Matching placebo tablets, oral administration
1033057|NCT00734630|P1|Participant Flow|Nebivolol|Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
1033058|NCT00734630|O2|Outcome|Placebo|Matching placebo tablets, oral administration
1033059|NCT00734630|O1|Outcome|Nebivolol|Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
1033060|NCT00734630|O2|Outcome|Placebo|Matching placebo tablets, oral administration
1033061|NCT00734630|O1|Outcome|Nebivolol|Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
1033062|NCT00734630|E2|Reported Event|Placebo|Matching placebo tablets, oral administration
1033063|NCT00734630|E1|Reported Event|Nebivolol|Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
1033064|NCT00734617|B3|Baseline|Total|Total of all reporting groups
1033065|NCT00734617|B2|Baseline|More Dependent|
1033066|NCT00734617|B1|Baseline|Less Dependent|
1033067|NCT00734617|P2|Participant Flow|More Dependent|
1033068|NCT00734617|P1|Participant Flow|Less Dependent|
1033069|NCT00734617|O2|Outcome|More Dependent|
1033070|NCT00734617|O1|Outcome|Less Dependent|
1033071|NCT00734617|E2|Reported Event|More Dependent|
1033072|NCT00734617|E1|Reported Event|Less Dependent|
1033073|NCT00734604|B7|Baseline|Total|Total of all reporting groups
1033074|NCT00734604|B6|Baseline|T(PRN)/S(PRN)/T(OaD)|Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks
1033075|NCT00734604|B5|Baseline|T(PRN)/T(OaD)/S(PRN)|Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks
1033076|NCT00734604|B4|Baseline|S(PRN)/T(PRN)/T(OaD)|Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks
1033077|NCT00734604|B3|Baseline|S(PRN)/T(OaD)/T(PRN)|Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks
1033078|NCT00734604|B2|Baseline|T(OaD)/T(PRN)/S(PRN)|Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks
1033079|NCT00734604|B1|Baseline|T(OaD)/S(PRN)/T(PRN)|Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks
1033080|NCT00734604|P6|Participant Flow|T(PRN)/S(PRN)/T(OaD)|Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks
1033081|NCT00734604|P5|Participant Flow|T(PRN)/T(OaD)/S(PRN)|Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks
1033082|NCT00734604|P4|Participant Flow|S(PRN)/T(PRN)/T(OaD)|Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks
1033083|NCT00734604|P3|Participant Flow|S(PRN)/T(OaD)/T(PRN)|Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks
1033084|NCT00734604|P2|Participant Flow|T(OaD)/T(PRN)/S(PRN)|Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks
1033085|NCT00734604|P1|Participant Flow|T(OaD)/S(PRN)/T(PRN)|Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks
1033086|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
1033087|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
1033088|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
1033089|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
1033090|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
1033091|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
1033092|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
1033093|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
1033094|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
1033095|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
1033096|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
1033098|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
1033099|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
1033100|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
1033101|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
1033102|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
1033103|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
1033104|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
1033105|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
1033106|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
1033107|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
1033108|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
1033109|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
1033110|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
1033111|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
1033112|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
1033113|NCT00734604|O3|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
1033114|NCT00734604|O2|Outcome|Tadalafil as Needed [T(PRN)]|tadalafil 20 mg as needed [T(PRN)]
1033115|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
1033116|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
1033117|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
1033118|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
1033119|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
1033120|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
1033121|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
1033122|NCT00734604|O3|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
1033123|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
1033124|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
1033125|NCT00734604|O2|Outcome|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
1033126|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
1033127|NCT00734604|O2|Outcome|Sildenafil as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
1033128|NCT00734604|O1|Outcome|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
1033129|NCT00734604|E3|Reported Event|Tadalafil as Needed [T(PRN)]|Tadalafil 20 mg as needed [T(PRN)]
1033130|NCT00734604|E2|Reported Event|Sildenafil Citrate as Needed [S(PRN)]|Sildenafil citrate 100 mg as needed [S(PRN)]
1033131|NCT00734604|E1|Reported Event|Tadalafil Once a Day [T(OaD)]|Tadalafil 5 mg once a day [T(OaD)]
1033132|NCT00734591|B3|Baseline|Total|Total of all reporting groups
1033133|NCT00734591|B2|Baseline|Previously Randomized to Comparator|Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
1033134|NCT00734591|B1|Baseline|Previously Randomized to Exubera|Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
1033135|NCT00734591|P2|Participant Flow|Previously Randomized to Comparator|Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
1033136|NCT00734591|P1|Participant Flow|Previously Randomized to Exubera|Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
1033137|NCT00734591|O2|Outcome|Previously Randomized to Comparator|Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
1033138|NCT00734591|O1|Outcome|Previously Randomized to Exubera|Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
1033139|NCT00734591|O2|Outcome|Previously Randomized to Comparator|Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
1033140|NCT00734591|O1|Outcome|Previously Randomized to Exubera|Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
1033209|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
1033141|NCT00734591|O2|Outcome|Previously Randomized to Comparator|Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
1033142|NCT00734591|O1|Outcome|Previously Randomized to Exubera|Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
1033143|NCT00734591|O2|Outcome|Previously Randomized to Comparator|Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
1033144|NCT00734591|O1|Outcome|Previously Randomized to Exubera|Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
1033145|NCT00734591|E2|Reported Event|Previously Randomized to Comparator|Participants randomized to comparator (Type 1 or Type 2 diabetes mellitus treatments such as injected insulin or oral agent therapy) in a prior Exubera-controlled trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
1033146|NCT00734591|E1|Reported Event|Previously Randomized to Exubera|Participants randomized to Exubera® (inhalable form of recombinant human [rh] insulin) per protocol in a prior Exubera-controlled clinical trial. There was no active study medication used in FUSE. During prospective follow-up all participants received treatment for diabetes mellitus per routine clinical practice.
1033147|NCT00734578|B4|Baseline|Total|Total of all reporting groups
1033148|NCT00734578|B3|Baseline|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
1033149|NCT00734578|B2|Baseline|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
1033150|NCT00734578|B1|Baseline|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
1033151|NCT00734578|P3|Participant Flow|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
1033152|NCT00734578|P2|Participant Flow|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
1033153|NCT00734578|P1|Participant Flow|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
1033154|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
1033155|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
1033156|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
1033157|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
1033158|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
1033159|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
1033160|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
1033211|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
1033212|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
1033161|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
1033162|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
1033163|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
1033164|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
1033165|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
1033166|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
1033167|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
1033168|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
1033169|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
1033170|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
1033171|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
1033172|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
1033173|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
1033174|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
1033175|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
1033176|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
1033177|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
1033178|NCT00734578|O3|Outcome|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
1033210|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
1033985|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
1033179|NCT00734578|O2|Outcome|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
1033180|NCT00734578|O1|Outcome|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
1033181|NCT00734578|E3|Reported Event|Placebo + Psychostimulant|Placebo was administered in both the AM and PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) each morning.
1033182|NCT00734578|E2|Reported Event|SPD503-PM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the PM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the AM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
1033183|NCT00734578|E1|Reported Event|SPD503-AM + Psychostimulant|Guanfacine Hydrochloride Extended Release administered in the AM plus a psychostimulant (subject was on a stable dose on entry and maintained throughout) administered each morning. This group received a matching placebo in the PM. An optimal dose of Guanfacine Hydrochloride Extended Release (1-4 mg/day once-daily) is determined for each subject over 5 weeks. The subject is then maintained on this optimal dose for an additional 3 weeks.
1033184|NCT00734539|B3|Baseline|Total|Total of all reporting groups
1033185|NCT00734539|B2|Baseline|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
1033186|NCT00734539|B1|Baseline|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
1033187|NCT00734539|P2|Participant Flow|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
1033188|NCT00734539|P1|Participant Flow|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
1033189|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for a total of up to 12-13 doses"
1033190|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6mg/kg IV/PO twice weekly for a total of up to 12-13 doses"
1033191|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly for a total of up to 12-13 doses"
1033192|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6mg/kg IV/PO twice weekly for a total of up to 12-13 doses"
1033193|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
1033194|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
1033195|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
1033196|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
1033197|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
1033198|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
1033199|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
1033200|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
1033201|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
1033202|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
1033203|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
1033204|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
1033205|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
1033206|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
1033207|NCT00734539|O2|Outcome|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
1033208|NCT00734539|O1|Outcome|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
1033816|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1033213|NCT00734539|E2|Reported Event|Placebo|"Placebo IV or PO twice weekly for 6 weeks~placebo: placebo: normal saline (IV) or 3 parts Ora Plus oral suspension vehicle and 1 part simethicone suspension (PO): will be given twice weekly PO/IV for 14 doses"
1033214|NCT00734539|E1|Reported Event|Fluconazole|"fluconazole 6mg/kg IV or PO twice weekly for 6 weeks~fluconazole: 6 mg/kg PO/IV twice weekly x 14 doses"
1033215|NCT00734500|B1|Baseline|Anidulafungin|Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
1033216|NCT00734500|P1|Participant Flow|Anidulafungin|Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
1033217|NCT00734500|O1|Outcome|Anidulafungin|Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
1033218|NCT00734500|O1|Outcome|Anidulafungin|Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
1033219|NCT00734500|E1|Reported Event|Anidulafungin|Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
1033220|NCT00734474|B10|Baseline|Total|Total of all reporting groups
1033221|NCT00734474|B9|Baseline|Placebo/Sitagliptin|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033222|NCT00734474|B8|Baseline|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033223|NCT00734474|B7|Baseline|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
1033224|NCT00734474|B6|Baseline|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
1033225|NCT00734474|B5|Baseline|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033226|NCT00734474|B4|Baseline|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
1033227|NCT00734474|B3|Baseline|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033228|NCT00734474|B2|Baseline|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
1033229|NCT00734474|B1|Baseline|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
1033230|NCT00734474|P9|Participant Flow|Placebo/Sitagliptin|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033231|NCT00734474|P8|Participant Flow|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033232|NCT00734474|P7|Participant Flow|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
1033233|NCT00734474|P6|Participant Flow|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
1033234|NCT00734474|P5|Participant Flow|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033275|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033277|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033986|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
1033235|NCT00734474|P4|Participant Flow|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
1033236|NCT00734474|P3|Participant Flow|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033237|NCT00734474|P2|Participant Flow|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
1033238|NCT00734474|P1|Participant Flow|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
1033239|NCT00734474|O10|Outcome|Placebo/Sitagliptin (26 Weeks Through 104 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033240|NCT00734474|O9|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033241|NCT00734474|O8|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033242|NCT00734474|O7|Outcome|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
1033243|NCT00734474|O6|Outcome|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
1033244|NCT00734474|O5|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033245|NCT00734474|O4|Outcome|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
1033246|NCT00734474|O3|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033247|NCT00734474|O2|Outcome|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
1033248|NCT00734474|O1|Outcome|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
1033249|NCT00734474|O10|Outcome|Placebo/Sitagliptin (26 Weeks Through 104 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033250|NCT00734474|O9|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033251|NCT00734474|O8|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033252|NCT00734474|O7|Outcome|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
1033276|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033253|NCT00734474|O6|Outcome|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
1033254|NCT00734474|O5|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033255|NCT00734474|O4|Outcome|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
1033256|NCT00734474|O3|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033257|NCT00734474|O2|Outcome|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
1033258|NCT00734474|O1|Outcome|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
1033259|NCT00734474|O1|Outcome|LY2189265|"LY2189265 (Dulaglutide): 3.0, 2.0, 1.5, 1.0, 0.75, 0.5, or 0.25 milligrams (mg), subcutaneous (SC), once weekly for up to 104 weeks.~Placebo: tablet, administered orally, once daily for up to 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks"
1033260|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033261|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033262|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033263|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033264|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033265|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033266|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033267|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033268|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033269|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033270|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033271|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033272|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033273|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033274|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033817|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1033278|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033279|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033280|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033281|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033282|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033283|NCT00734474|O9|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033284|NCT00734474|O8|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033285|NCT00734474|O7|Outcome|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
1033286|NCT00734474|O6|Outcome|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
1033287|NCT00734474|O5|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033288|NCT00734474|O4|Outcome|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
1033289|NCT00734474|O3|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033290|NCT00734474|O2|Outcome|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
1033291|NCT00734474|O1|Outcome|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
1033292|NCT00734474|O9|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033293|NCT00734474|O8|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033294|NCT00734474|O7|Outcome|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
1033295|NCT00734474|O6|Outcome|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
1033296|NCT00734474|O5|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033818|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1033340|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033297|NCT00734474|O4|Outcome|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
1033298|NCT00734474|O3|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033299|NCT00734474|O2|Outcome|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
1033300|NCT00734474|O1|Outcome|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
1033301|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033302|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033303|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033304|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033305|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033306|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033307|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033308|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033309|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033310|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033311|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033312|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033313|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033314|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033315|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033316|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033317|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033318|NCT00734474|O8|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033439|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
1033319|NCT00734474|O7|Outcome|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
1033320|NCT00734474|O6|Outcome|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
1033321|NCT00734474|O5|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033322|NCT00734474|O4|Outcome|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
1033323|NCT00734474|O3|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033324|NCT00734474|O2|Outcome|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
1033325|NCT00734474|O1|Outcome|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
1033326|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033327|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033328|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033329|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033330|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033331|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033332|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033333|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033334|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033335|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033336|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033337|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033338|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033339|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033341|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033342|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033343|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033344|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033345|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033346|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033347|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033348|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033349|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033350|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033351|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033352|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033353|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033354|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033355|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033356|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033357|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033358|NCT00734474|O9|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033359|NCT00734474|O8|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033360|NCT00734474|O7|Outcome|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
1033361|NCT00734474|O6|Outcome|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
1033362|NCT00734474|O5|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033363|NCT00734474|O4|Outcome|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
1033364|NCT00734474|O3|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033365|NCT00734474|O2|Outcome|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
1033366|NCT00734474|O1|Outcome|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
1033367|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033368|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033369|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033370|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033371|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033372|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033373|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033374|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033375|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033376|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033377|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033378|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033379|NCT00734474|O4|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033380|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033381|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033382|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033440|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
1033975|NCT00733421|B3|Baseline|Total|Total of all reporting groups
1033443|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
1033820|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1033383|NCT00734474|O9|Outcome|Placebo/Sitagliptin (Baseline Through 26 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033384|NCT00734474|O8|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033385|NCT00734474|O7|Outcome|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
1033386|NCT00734474|O6|Outcome|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
1033387|NCT00734474|O5|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033388|NCT00734474|O4|Outcome|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
1033389|NCT00734474|O3|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033390|NCT00734474|O2|Outcome|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
1033391|NCT00734474|O1|Outcome|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
1033392|NCT00734474|O3|Outcome|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033393|NCT00734474|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033394|NCT00734474|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033395|NCT00734474|E9|Reported Event|Placebo/Sitagliptin (Baseline Through 104 Weeks)|"Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 26 weeks~Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily, for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033396|NCT00734474|E8|Reported Event|Sitagliptin|"Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks~Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033397|NCT00734474|E7|Reported Event|0.25 mg LY2189265|"LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
1033398|NCT00734474|E6|Reported Event|0.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 27.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 27.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 27.4 weeks)"
1033399|NCT00734474|E5|Reported Event|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally, for 104 weeks"
1033400|NCT00734474|E4|Reported Event|1.0 mg LY2189265|"LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.4 weeks)"
1033401|NCT00734474|E3|Reported Event|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for 104 weeks~Placebo: tablet, administered orally, once daily for 104 weeks~Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks"
1033441|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
1033442|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
1033402|NCT00734474|E2|Reported Event|2.0 mg LY2189265|"LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 20.4 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 20.4 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 20.4 weeks)"
1033403|NCT00734474|E1|Reported Event|3.0 mg LY2189265|"LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly up to decision point (maximum exposure duration of 24.1 weeks)~Placebo: tablet, administered orally, once daily up to decision point (maximum exposure duration of 24.1 weeks)~Metformin: at least 1500 milligrams per day (mg/day), administered orally up to decision point (maximum exposure duration of 24.1 weeks)"
1033404|NCT00734409|B3|Baseline|Total|Total of all reporting groups
1033405|NCT00734409|B2|Baseline|RASS Only|Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
1033406|NCT00734409|B1|Baseline|RASS Plus BIS|Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.
1033407|NCT00734409|P2|Participant Flow|RASS Only|Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
1033408|NCT00734409|P1|Participant Flow|RASS Plus BIS|Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.
1033409|NCT00734409|O2|Outcome|RASS Only|Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
1033410|NCT00734409|O1|Outcome|RASS Plus BIS|Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.
1033411|NCT00734409|O2|Outcome|RASS Only|Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
1033412|NCT00734409|O1|Outcome|RASS Plus BIS|Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.
1033413|NCT00734409|O2|Outcome|RASS Only|Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
1033414|NCT00734409|O1|Outcome|RASS Plus BIS|Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.
1033415|NCT00734409|E2|Reported Event|RASS Only|Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
1033416|NCT00734409|E1|Reported Event|RASS Plus BIS|Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.
1033417|NCT00734344|B3|Baseline|Total|Total of all reporting groups
1033418|NCT00734344|B2|Baseline|Arm 2|"Efavirenz plus Truvada~Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily"
1033419|NCT00734344|B1|Baseline|Arm 1|"Raltegravir plus Truvada~Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily"
1033420|NCT00734344|P2|Participant Flow|Arm 2|"Efavirenz plus Truvada~Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily"
1033421|NCT00734344|P1|Participant Flow|Arm 1|"Raltegravir plus Truvada~Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily"
1033422|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
1033423|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
1033424|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
1033425|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
1033426|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
1033427|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
1033428|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
1033429|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
1033430|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
1033431|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
1033432|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
1033433|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
1033434|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
1033435|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
1033436|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
1033437|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
1033438|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
1033444|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
1033445|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
1033446|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
1033447|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
1033448|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
1033449|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
1033450|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
1033451|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
1033452|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
1033453|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
1033454|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
1033455|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
1033456|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
1033457|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
1033458|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
1033459|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
1033460|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
1033461|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
1033462|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
1033463|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
1033464|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
1033465|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
1033466|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
1033467|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
1033468|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
1033469|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
1033470|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
1033471|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
1033472|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
1033473|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
1033474|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
1033475|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
1033476|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
1033477|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
1033478|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
1034380|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
1033479|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
1033480|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
1033481|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
1033482|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
1033483|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
1033484|NCT00734344|O2|Outcome|Efavirenz Plus Truvada|Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
1033485|NCT00734344|O1|Outcome|Raltegravir Plus Truvada|Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily
1033486|NCT00734344|E2|Reported Event|Arm 2|"Efavirenz plus Truvada~Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily"
1033487|NCT00734344|E1|Reported Event|Arm 1|"Raltegravir plus Truvada~Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily"
1033488|NCT00734305|B3|Baseline|Total|Total of all reporting groups
1033489|NCT00734305|B2|Baseline|MM-121 Expansion Cohort|Expansion cohort at recommended phase 2 dose
1033490|NCT00734305|B1|Baseline|MM-121 Dose Escalation|MM-121: Dose escalation Frequency - once weekly IV
1033491|NCT00734305|P7|Participant Flow|Expansion Cohort|(Highest tested dose in absence of reaching maximum tolerated dose) 40 mg/kg IV loading dose on C1W1 followed by weekly maintenance doses of 20 mg/kg IV QW
1033492|NCT00734305|P6|Participant Flow|Dose Escalation: Cohort 6|MM-121: 40 mg/kg IV loading dose on C1W1 followed by weekly maintenance doses of 20 mg/kg IV QW
1033493|NCT00734305|P5|Participant Flow|Dose Escalation: Cohort 5|MM-121: 20 mg/kg IV QW
1033494|NCT00734305|P4|Participant Flow|Dose Escalation: Cohort 4|MM-121: 15 mg/kg IV QW
1033495|NCT00734305|P3|Participant Flow|Dose Escalation: Cohort 3|MM-121: 10 mg/kg IV QW
1033496|NCT00734305|P2|Participant Flow|Dose Escalation: Cohort 2|MM-121: 6 mg/kg IV QW
1033497|NCT00734305|P1|Participant Flow|Dose Escalation: Cohort 1|MM-121: 3.2 mg/kg IV QW
1033498|NCT00734305|O6|Outcome|Recommended Phase 2 Dose|MM-121: 40 mg/kg IV loading dose followed by 20 mg/kg IV QW maintenance doses Combination of Cohort 6 patients (N=4) and Expansion Cohort Patients (N=18) that received this dose level.
1033499|NCT00734305|O5|Outcome|Cohort 5|MM-121: 20 mg/kg IV QW
1033500|NCT00734305|O4|Outcome|Cohort 4|MM-121: 15 mg/kg IV QW
1033501|NCT00734305|O3|Outcome|Cohort 3|MM-121: 10 mg/kg IV QW
1033502|NCT00734305|O2|Outcome|Cohort 2|MM-121: 6 mg/kg IV QW
1033503|NCT00734305|O1|Outcome|Cohort 1|MM-121 3.2 mg/kg IV QW
1033504|NCT00734305|O6|Outcome|Recommended Phase 2 Dose|MM-121: 40 mg/kg IV loading dose followed by 20 mg/kg IV QW maintenance doses Combination of Cohort 6 patients (N=4) and Expansion Cohort Patients (N=18) that received this dose level.
1033505|NCT00734305|O5|Outcome|Cohort 5|MM-121: 20 mg/kg IV QW
1033506|NCT00734305|O4|Outcome|Cohort 4|MM-121: 15 mg/kg IV QW
1033507|NCT00734305|O3|Outcome|Cohort 3|MM-121: 10 mg/kg IV QW
1033508|NCT00734305|O2|Outcome|Cohort 2|MM-121: 6 mg/kg IV QW
1033509|NCT00734305|O1|Outcome|Cohort 1|MM-121 3.2 mg/kg IV QW
1033510|NCT00734305|O6|Outcome|Cohort 6|MM-121: 40 mg/kg IV loading dose followed by 20 mg/kg IV QW maintenance doses
1033511|NCT00734305|O5|Outcome|Cohort 5|MM-121: 20 mg/kg IV QW
1033512|NCT00734305|O4|Outcome|Cohort 4|MM-121: 15 mg/kg IV QW
1033513|NCT00734305|O3|Outcome|Cohort 3|MM-121: 10 mg/kg IV QW
1033514|NCT00734305|O2|Outcome|Cohort 2|MM-121: 6 mg/kg IV QW
1033515|NCT00734305|O1|Outcome|Cohort 1|MM-121 3.2 mg/kg IV QW
1033516|NCT00734305|O1|Outcome|Dose Escalation: All Participants|MM-121: Dose escalation Frequency - once weekly
1033517|NCT00734305|O7|Outcome|MM-121 Expansion Cohort|Expansion cohort at recommended phase 2 dose
1033518|NCT00734305|O6|Outcome|Dose Escalation: Cohort 6|MM-121 40 mg/kg IV loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV weekly maintenance doses
1033519|NCT00734305|O5|Outcome|Dose Escalation: Cohort 5|MM-121 20 mg/kg IV QW
1033520|NCT00734305|O4|Outcome|Dose Escalation: Cohort 4|MM-121 15 mg/kg IV QW
1033521|NCT00734305|O3|Outcome|Dose Escalation: Cohort 3|MM-121 10 mg/kg IV QW
1033522|NCT00734305|O2|Outcome|Dose Escalation: Cohort 2|MM-121 6 mg/kg IV QW
1033523|NCT00734305|O1|Outcome|Dose Escalation: Cohort 1|MM-121: 3.2 mg/kg IV QW
1033524|NCT00734305|E1|Reported Event|All Participatants|Dose Escalation cohort participants + Expansion cohort participants
1033525|NCT00734214|B3|Baseline|Total|Total of all reporting groups
1033526|NCT00734214|B2|Baseline|0.45% NaCl|
1033527|NCT00734214|B1|Baseline|0.9% NaCl|
1033528|NCT00734214|P2|Participant Flow|0.45% NaCl|
1033529|NCT00734214|P1|Participant Flow|0.9% NaCl|
1033530|NCT00734214|O2|Outcome|0.45% NaCl|
1033531|NCT00734214|O1|Outcome|0.9% NaCl|
1033532|NCT00734214|E2|Reported Event|0.45% NaCl|
1033533|NCT00734214|E1|Reported Event|0.9% NaCl|
1033534|NCT00734162|B5|Baseline|Total|Total of all reporting groups
1033535|NCT00734162|B4|Baseline|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033536|NCT00734162|B3|Baseline|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033537|NCT00734162|B2|Baseline|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033538|NCT00734162|B1|Baseline|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033539|NCT00734162|P4|Participant Flow|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033540|NCT00734162|P3|Participant Flow|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033541|NCT00734162|P2|Participant Flow|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033542|NCT00734162|P1|Participant Flow|TDF 12-14 Years|Tenofovir disoproxil fumarate (TDF) 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033543|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033544|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033545|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033546|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033547|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033548|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033549|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033550|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033551|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033552|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033553|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033554|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033555|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033556|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033557|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033558|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033559|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033560|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033561|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033562|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033563|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033564|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033565|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033566|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033567|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033568|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033569|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033570|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033571|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033572|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033573|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033574|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033575|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033576|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033577|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033578|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033579|NCT00734162|O2|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033580|NCT00734162|O1|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033581|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033582|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033583|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033584|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033585|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033586|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033587|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033588|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033589|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033590|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033591|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033592|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033593|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033594|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033595|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033596|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033597|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033598|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033599|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033600|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033601|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033602|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033603|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033604|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033605|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033606|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033607|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033608|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033609|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033610|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033611|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033612|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033613|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033614|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033615|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033616|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033617|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033618|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033619|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033620|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033621|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033622|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033623|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033624|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033625|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033626|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033627|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033628|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033629|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033630|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033631|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033632|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033633|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033634|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033635|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033636|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033637|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033638|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033639|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033640|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033641|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033642|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033643|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033644|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033645|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033646|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033647|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033648|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033649|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033650|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033651|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033652|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033653|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033654|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033655|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033656|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033657|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033658|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033659|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033660|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033661|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033662|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033663|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033664|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033665|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033666|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033667|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033668|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033669|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033670|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033671|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033672|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033673|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033674|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033675|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033676|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033677|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033678|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033679|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033680|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033681|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033682|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033683|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033684|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033685|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033686|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033687|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033688|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033689|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033690|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033691|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033692|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033693|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033694|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033695|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033696|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033697|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033698|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033699|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033700|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033701|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033702|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033703|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033704|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033705|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033706|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033707|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033708|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033709|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033710|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033711|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033712|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033713|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033714|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033715|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033716|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033717|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033718|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033719|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033720|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033721|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033722|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033723|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033724|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033725|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033726|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033727|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033728|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033729|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033730|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033731|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033732|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033733|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033734|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033735|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033736|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033737|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033738|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033739|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033740|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033741|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033742|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033743|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033744|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033745|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033746|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033747|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033748|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033749|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033750|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033751|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033752|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033753|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033754|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033755|NCT00734162|O6|Outcome|Total Placebo 12-17 Years|TDF placebo tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033756|NCT00734162|O5|Outcome|Total TDF 12-17 Years|TDF 300 mg tablet once daily in participants 12-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033757|NCT00734162|O4|Outcome|Placebo 15-17 Years|TDF placebo tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033758|NCT00734162|O3|Outcome|Placebo 12-14 Years|TDF placebo tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033759|NCT00734162|O2|Outcome|TDF 15-17 Years|TDF 300 mg tablet once daily in participants 15-17 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033760|NCT00734162|O1|Outcome|TDF 12-14 Years|TDF 300 mg tablet once daily in participants 12-14 years of age in the Randomized Phase, followed by TDF 300 mg tablet once daily in the Open-Label Phase
1033761|NCT00734162|E4|Reported Event|Open-Label Placebo-TDF|Adverse events reported in this group occurred during the Open-Label Phase and includes all participants who received placebo during the Randomized Phase of the study and continued to the Open-Label Phase.
1033762|NCT00734162|E3|Reported Event|Open-Label TDF-TDF|Adverse events reported in this group occurred during the Open-Label Phase and includes all participants who received double-blind TDF during the Randomized Phase of the study and continued to the Open-Label Phase.
1033763|NCT00734162|E2|Reported Event|Double-Blind Placebo|Adverse events reported in this group occurred during the Randomized Phase (+7 days for participants who did not continue to the Open-Label Phase) and includes all participants who received placebo during the Randomized Phase of the study.
1033764|NCT00734162|E1|Reported Event|Double-Blind TDF|Adverse events reported in this group occurred during the Randomized Phase (+7 days for participants who did not continue to the Open-Label Phase) and includes all participants who received double-blind TDF during the Randomized Phase of the study.
1033765|NCT00734149|B1|Baseline|Bortezomib+Melphalan+Prednisone|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle.
1033766|NCT00734149|P1|Participant Flow|Bortezomib+Melphalan+Prednisone|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle.
1033767|NCT00734149|O2|Outcome|Bortezomib+Melphalan+Prednisone: ASCT|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle. Patients proceeded to autologous stem cell transplant (ASCT).
1033768|NCT00734149|O1|Outcome|Bortezomib+Melphalan+Prednisone: Non-ASCT|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle. Patients did not proceed to autologous stem cell transplant (ASCT).
1033976|NCT00733421|B2|Baseline|Control Tramadol|Tramadol 100 mg slow release twice daily
1033819|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1033874|NCT00733993|O3|Outcome|Caffeine 300 mg|Caffeine 300 mg
1033769|NCT00734149|O1|Outcome|Bortezomib+Melphalan+Prednisone|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle.
1033770|NCT00734149|O1|Outcome|Bortezomib+Melphalan+Prednisone|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle.
1033771|NCT00734149|E1|Reported Event|Bortezomib+Melphalan+Prednisone|Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle.
1033772|NCT00734097|B1|Baseline|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
1033773|NCT00734097|P1|Participant Flow|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
1033774|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
1033775|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
1033776|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
1033777|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
1033778|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
1033779|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
1033780|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
1033781|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
1033782|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
1033783|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
1033784|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
1033785|NCT00734097|O1|Outcome|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
1033786|NCT00734097|E1|Reported Event|Esomeprazole 40mg, Daily|Open-label daily esomeprazole 40 mg, daily for 8 weeks
1033787|NCT00734071|B3|Baseline|Total|Total of all reporting groups
1033788|NCT00734071|B2|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1033789|NCT00734071|B1|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1033790|NCT00734071|P2|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1033791|NCT00734071|P1|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1033792|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1033793|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1033794|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1033795|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1033796|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1033797|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1033798|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1033799|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1033800|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1033801|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1033802|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1033803|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1033804|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1033805|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1033806|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1033807|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1033808|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1033809|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1033810|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1033811|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1033812|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1033813|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1033814|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1033815|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1033977|NCT00733421|B1|Baseline|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
1033821|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1033822|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1033823|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1033824|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1033825|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1033826|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1033827|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1033828|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1033829|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1033830|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1033831|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1033832|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1033833|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1033834|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1033835|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1033836|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1033837|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1033838|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1033839|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1033840|NCT00734071|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1033841|NCT00734071|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1033842|NCT00734071|E2|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
1033843|NCT00734071|E1|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1033844|NCT00733993|B3|Baseline|Total|Total of all reporting groups
1033845|NCT00733993|B2|Baseline|Control Participants|Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
1033846|NCT00733993|B1|Baseline|Cocaine Users|Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
1033847|NCT00733993|P2|Participant Flow|Control Participants|"Control participants were allocated to different sequence orders for the 5 interventions~Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
1033848|NCT00733993|P1|Participant Flow|Cocaine Users|"Cocaine users were allocated to different sequence orders for the 5 interventions~Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
1033849|NCT00733993|O4|Outcome|Amphetamine 20mg|Amphetamine 20mg
1033850|NCT00733993|O3|Outcome|Caffeine 300 mg|Caffeine 300mg
1033851|NCT00733993|O2|Outcome|Caffeine 150 Mg|150 MG of Caffeine
1033852|NCT00733993|O1|Outcome|Placebo|"Placebo~Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
1033853|NCT00733993|O4|Outcome|Amphetamine 20mg|Amphetamine 20mg
1033854|NCT00733993|O3|Outcome|Caffeine 300 mg|Caffeine 300mg
1033855|NCT00733993|O2|Outcome|Caffeine 150 Mg|150 MG of Caffeine
1033856|NCT00733993|O1|Outcome|Placebo|"Placebo~Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
1033857|NCT00733993|O4|Outcome|Amphetamine 20 mg|Amphetamine 20 mg
1033858|NCT00733993|O3|Outcome|Caffeine 300 mg|Caffeine 300 mg
1033859|NCT00733993|O2|Outcome|Caffeine 150 Mg|150 MG of Caffeine
1033860|NCT00733993|O1|Outcome|Placebo|"Placebo~Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
1033861|NCT00733993|O4|Outcome|Amphetamine 20 mg|Amphetamine 20 mg
1033862|NCT00733993|O3|Outcome|Caffeine 300 mg|Caffeine 300 mg
1033863|NCT00733993|O2|Outcome|Caffeine 150 Mg|150 MG of Caffeine
1033864|NCT00733993|O1|Outcome|Placebo|"Placebo~Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
1033865|NCT00733993|O4|Outcome|Amphetamine 20mg|Amphetamine 20mg
1033866|NCT00733993|O3|Outcome|Caffeine 300 mg|Caffeine 300mg
1033867|NCT00733993|O2|Outcome|Caffeine 150 Mg|150 MG of Caffeine
1033868|NCT00733993|O1|Outcome|Placebo|"Placebo~Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
1033869|NCT00733993|O4|Outcome|Amphetamine 20mg|Amphetamine 20mg
1033870|NCT00733993|O3|Outcome|Caffeine 300 mg|Caffeine 300mg
1033871|NCT00733993|O2|Outcome|Caffeine 150 Mg|150 MG of Caffeine
1033978|NCT00733421|P2|Participant Flow|Control Tramadol|Tramadol 100 mg slow release twice daily
1033872|NCT00733993|O1|Outcome|Placebo|"Placebo~Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
1033873|NCT00733993|O4|Outcome|Amphetamine 20 mg|Amphetamine 20 mg
1033876|NCT00733993|O1|Outcome|Placebo|"Placebo~Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
1033877|NCT00733993|E3|Reported Event|3 Amphetamine|Amphetamine: Across five separate testing days, subjects were administered two placebo doses, 20 mg damphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
1033878|NCT00733993|E2|Reported Event|2 Placebo|"Placebo~Placebo: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
1033879|NCT00733993|E1|Reported Event|1 Caffeine|"Caffeine~Caffeine: Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion"
1033880|NCT00733954|B3|Baseline|Total|Total of all reporting groups
1033881|NCT00733954|B2|Baseline|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
1033882|NCT00733954|B1|Baseline|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
1033883|NCT00733954|P2|Participant Flow|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
1033884|NCT00733954|P1|Participant Flow|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
1033885|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
1033886|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
1033887|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
1033888|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
1033889|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
1033890|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
1033891|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
1033892|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
1033893|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
1033894|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
1033895|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
1033896|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
1033897|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
1033898|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
1033899|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
1033900|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
1033901|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
1033902|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
1033903|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
1033904|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
1033905|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
1033906|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
1033907|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
1033908|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
1033909|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
1033910|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
1033911|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
1033912|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
1033913|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
1033914|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
1033915|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
1033916|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
1033917|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
1033918|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
1033919|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
1033920|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
1033921|NCT00733954|O2|Outcome|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
1033922|NCT00733954|O1|Outcome|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
1033923|NCT00733954|E2|Reported Event|Clobetasol Propionate Ointment|clobetasol propionate ointment 0.05%
1033924|NCT00733954|E1|Reported Event|Clobetasol Propionate Spray|clobetasol propionate spray 0.05%
1033925|NCT00733824|B6|Baseline|Total|Total of all reporting groups
1033926|NCT00733824|B5|Baseline|Phase II|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
1033927|NCT00733824|B4|Baseline|Cohort 4|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
1033928|NCT00733824|B3|Baseline|Cohort 3|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
1033929|NCT00733824|B2|Baseline|Cohort 2|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
1033987|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
1033988|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
1033930|NCT00733824|B1|Baseline|Cohort 1|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
1033931|NCT00733824|P5|Participant Flow|Phase II|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
1033932|NCT00733824|P4|Participant Flow|Phase I - Cohort 4|240 µg/kg SC AMD3100 Day -5 10 µg/kg SC G-CSF Day -4 thru Day -1 400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1 Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
1033933|NCT00733824|P3|Participant Flow|Phase I - Cohort 3|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
1033934|NCT00733824|P2|Participant Flow|Phase I - Cohort 2|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
1033935|NCT00733824|P1|Participant Flow|Phase I - Cohort 1|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
1033936|NCT00733824|O5|Outcome|Phase II|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)~AMD3100~G-CSF~Apheresis"
1033937|NCT00733824|O4|Outcome|Cohort 4|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
1033938|NCT00733824|O3|Outcome|Cohort 3|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
1033939|NCT00733824|O2|Outcome|Cohort 2|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
1033940|NCT00733824|O1|Outcome|Cohort 1|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
1033941|NCT00733824|O1|Outcome|Phase 1 and Phase 2 Participants|
1033942|NCT00733824|O1|Outcome|Phase 1 and Phase 2 Participants|
1033943|NCT00733824|O4|Outcome|Cohort 4|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
1033944|NCT00733824|O3|Outcome|Cohort 3|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
1033945|NCT00733824|O2|Outcome|Cohort 2|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
1033946|NCT00733824|O1|Outcome|Cohort 1|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
1033947|NCT00733824|O1|Outcome|Phase 1 (Dose Levels 1-4)|
1033948|NCT00733824|E5|Reported Event|Phase II|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
1033949|NCT00733824|E4|Reported Event|Cohort 4|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
1033950|NCT00733824|E3|Reported Event|Cohort 3|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
1033951|NCT00733824|E2|Reported Event|Cohort 2|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
1033952|NCT00733824|E1|Reported Event|Cohort 1|"240 µg/kg SC AMD3100 Day -5~10 µg/kg SC G-CSF Day -4 thru Day -1~160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1~Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)"
1033953|NCT00733746|B1|Baseline|Neoadjuvant Therapy + Surgery + Adjuvant Therapy|"Neoadjuvant Therapy:~As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.~Surgery:~Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.~Adjuvant Therapy:~Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery."
1033979|NCT00733421|P1|Participant Flow|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
1033980|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
1033981|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
1033982|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
1033983|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
1033984|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
1033989|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
1033990|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
1033954|NCT00733746|P1|Participant Flow|Neoadjuvant Therapy + Surgery + Adjuvant Therapy|"Neoadjuvant Therapy:~As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.~Surgery:~Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.~Adjuvant Therapy:~Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery."
1033955|NCT00733746|O1|Outcome|Neoadjuvant Therapy + Surgery + Adjuvant Therapy|"Neoadjuvant Therapy:~As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.~Surgery:~Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.~Adjuvant Therapy:~Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery."
1033956|NCT00733746|O1|Outcome|Neoadjuvant Therapy + Surgery + Adjuvant Therapy|"Neoadjuvant Therapy:~As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.~Surgery:~Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.~Adjuvant Therapy:~Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery."
1033957|NCT00733746|O1|Outcome|Neoadjuvant Therapy + Surgery + Adjuvant Therapy|"Neoadjuvant Therapy:~As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.~Surgery:~Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.~Adjuvant Therapy:~Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery."
1033958|NCT00733746|O1|Outcome|Neoadjuvant Therapy + Surgery + Adjuvant Therapy|"Neoadjuvant Therapy:~As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.~Surgery:~Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.~Adjuvant Therapy:~Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery."
1033959|NCT00733746|O1|Outcome|Neoadjuvant Therapy + Surgery + Adjuvant Therapy|"Neoadjuvant Therapy:~As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.~Surgery:~Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.~Adjuvant Therapy:~Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery."
1033960|NCT00733746|E1|Reported Event|Neoadjuvant Therapy + Surgery + Adjuvant Therapy|"Neoadjuvant Therapy:~As part of neoadjuvant therapy, patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and 100 mg oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity.~Surgery:~Within 3-6 weeks after completion of neoadjuvant therapy, patients are reevaluated for eligibility for pancreaticoduodenectomy.~Adjuvant Therapy:~Patients that receive pancreaticoduodenectomy according to protocol are given 1000 mg/m2 gemcitabine hydrochloride IV on days 1, 8, 15, 29, 36, and 43 and 100 mg erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post-surgery."
1033961|NCT00733512|B1|Baseline|ReSTOR|Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
1033962|NCT00733512|P1|Participant Flow|ReSTOR|Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
1033963|NCT00733512|O1|Outcome|ReSTOR|Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
1033964|NCT00733512|O1|Outcome|ReSTOR|Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
1033965|NCT00733512|E1|Reported Event|ReSTOR|Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
1033966|NCT00733499|B3|Baseline|Total|Total of all reporting groups
1033967|NCT00733499|B2|Baseline|LCS Complete Porocoat|102 patients LCS Complete Porocoat : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
1033968|NCT00733499|B1|Baseline|LCS Complete Duofix|102 patients LCS Complete Duofix : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
1033969|NCT00733499|P2|Participant Flow|LCS Complete Porocoat|103 patients LCS Complete Porocoat : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
1033970|NCT00733499|P1|Participant Flow|LCS Complete Duofix|102 patients LCS Complete Duofix : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
1033971|NCT00733499|O2|Outcome|LCS Complete Porocoat|102 patients LCS Complete Porocoat : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
1033972|NCT00733499|O1|Outcome|LCS Complete Duofix|102 patients LCS Complete Duofix : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
1033973|NCT00733499|E2|Reported Event|LCS Complete Porocoat|103 patients LCS Complete Porocoat : Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces
1033974|NCT00733499|E1|Reported Event|LCS Complete Duofix|102 patients LCS Complete Duofix : Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
1033991|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
1033992|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
1033993|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
1033994|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
1033995|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
1033996|NCT00733421|O2|Outcome|Control Tramadol|Tramadol 100 mg slow release twice daily
1033997|NCT00733421|O1|Outcome|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
1033998|NCT00733421|E2|Reported Event|Control Tramadol|Tramadol 100 mg slow release twice daily
1033999|NCT00733421|E1|Reported Event|Etoricoxib|"Active study drug:~Etoricoxib 90 mg once daily"
1034000|NCT00733369|B3|Baseline|Total|Total of all reporting groups
1034001|NCT00733369|B2|Baseline|PFC Sigma RP|"125 patients to be allocated to this arm according to blinding envelopes~PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing"
1034002|NCT00733369|B1|Baseline|PFC Sigma RP-F|"125 patients to be allocated to this arm according to blinding envelopes~PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing"
1034003|NCT00733369|P2|Participant Flow|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034004|NCT00733369|P1|Participant Flow|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034005|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034006|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034007|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034008|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034009|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034010|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034011|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034012|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034013|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034014|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034015|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034016|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034017|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034018|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034019|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034020|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034021|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034022|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034023|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034024|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034025|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034026|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034027|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034028|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034029|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034030|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034031|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034032|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034033|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034034|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034035|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034036|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034037|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034038|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034039|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034040|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034041|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034042|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034043|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034044|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034045|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034046|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034047|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034048|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034049|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034050|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034051|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034052|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034053|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034054|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034055|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034056|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034057|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034058|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034059|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034060|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034061|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034062|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034063|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034064|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034065|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034066|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034067|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034068|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034069|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034070|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034071|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034072|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034073|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034074|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034075|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034076|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034077|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034078|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034079|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034080|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034081|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034082|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034083|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034084|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034085|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034086|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034087|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034088|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034089|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034090|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034091|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034092|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034093|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034094|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034095|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034096|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034097|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034098|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034099|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034100|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034101|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034102|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034103|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034104|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034105|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034106|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034107|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034108|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034109|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034110|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034111|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034112|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034113|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034114|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034115|NCT00733369|O2|Outcome|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034116|NCT00733369|O1|Outcome|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034117|NCT00733369|E2|Reported Event|PFC Sigma RP|PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
1034118|NCT00733369|E1|Reported Event|PFC Sigma RP-F|PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
1034119|NCT00733330|B3|Baseline|Total|Total of all reporting groups
1034170|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034120|NCT00733330|B2|Baseline|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034121|NCT00733330|B1|Baseline|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
1034381|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
1034122|NCT00733330|P2|Participant Flow|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034123|NCT00733330|P1|Participant Flow|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
1034124|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034125|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
1034126|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034127|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
1034128|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034129|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
1034130|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034131|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
1034132|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034133|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
1034134|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034135|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
1034136|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034137|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
1034138|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034139|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
1034140|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034141|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
1034142|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034143|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
1034144|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034145|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
1034146|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034147|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
1034148|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034149|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
1034150|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034151|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
1034152|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034153|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
1034154|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034155|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
1034156|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034157|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
1034158|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034159|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
1034160|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034161|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
1034162|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034163|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
1034164|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034165|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
1034166|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034167|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
1034168|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034169|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
1034171|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
1034172|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034382|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
1034383|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
1034173|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
1034174|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034175|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
1034176|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034177|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
1034178|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034179|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
1034180|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034181|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
1034182|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034183|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
1034184|NCT00733330|O2|Outcome|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034185|NCT00733330|O1|Outcome|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
1034186|NCT00733330|O2|Outcome|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034187|NCT00733330|O1|Outcome|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
1034188|NCT00733330|O2|Outcome|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034189|NCT00733330|O1|Outcome|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
1034190|NCT00733330|O2|Outcome|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034191|NCT00733330|O1|Outcome|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
1034192|NCT00733330|O2|Outcome|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034193|NCT00733330|O1|Outcome|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
1034194|NCT00733330|O2|Outcome|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034195|NCT00733330|O1|Outcome|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
1034196|NCT00733330|O2|Outcome|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034197|NCT00733330|O1|Outcome|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
1034198|NCT00733330|O2|Outcome|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034199|NCT00733330|O1|Outcome|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
1034200|NCT00733330|O2|Outcome|Conventional TKR Arm|Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034201|NCT00733330|O1|Outcome|MiTKR CAS Arm|Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation
1034202|NCT00733330|E2|Reported Event|Conventional TKR Arm|Either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique
1034203|NCT00733330|E1|Reported Event|MiTKR CAS Arm|Either a P.F.C. or L.C.S. using minimally invasive surgery and computer navigation
1034204|NCT00733291|B3|Baseline|Total|Total of all reporting groups
1034205|NCT00733291|B2|Baseline|Etafilcon A Contact Lens|Commercially marketed, single vision, soft contact lens for daily disposable wear
1034206|NCT00733291|B1|Baseline|Nelfilcon A Contact Lens|Commercially marketed, single vision, soft contact lens for daily disposable wear
1034207|NCT00733291|P4|Participant Flow|Etafilcon A no Soak / Etafilcon Soak|Etafilcon A contact lenses inserted directly out of the blister package, followed by etafilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours.
1034208|NCT00733291|P3|Participant Flow|Etafilcon A Soak / Etafilcon A no Soak|Nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by nelfilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours.
1034209|NCT00733291|P2|Participant Flow|Nelfilcon A no Soak / Nelfilcon A Soak|Nelfilcon A contact lenses inserted directly out of the blister package, followed by nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours.
1034210|NCT00733291|P1|Participant Flow|Nelfilcon A Soak / Nelfilcon A no Soak|Nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by nelfilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours.
1034211|NCT00733291|O4|Outcome|Etafilcon A / no Soak|Etafilcon A contact lenses inserted directly out of the blister package
1034384|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
1034385|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
1034212|NCT00733291|O3|Outcome|Etafilcon A / FID 107027|Etafilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
1034213|NCT00733291|O2|Outcome|Nelfilcon A / no Soak|Nelfilcon A contact lenses inserted directly out of the blister package
1034214|NCT00733291|O1|Outcome|Nelfilcon A / FID 107027|Nelfilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
1034215|NCT00733291|O4|Outcome|Etafilcon A / no Soak|Etafilcon A contact lenses inserted directly out of the blister package
1034216|NCT00733291|O3|Outcome|Etafilcon A / FID 107027|Etafilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
1034217|NCT00733291|O2|Outcome|Nelfilcon A / no Soak|Nelfilcon A contact lenses inserted directly out of the blister package
1034218|NCT00733291|O1|Outcome|Nelfilcon A / FID 107027|Nelfilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
1034219|NCT00733291|O4|Outcome|Etafilcon A / no Soak|Etafilcon A contact lenses inserted directly out of the blister package
1034220|NCT00733291|O3|Outcome|Etafilcon A / FID 107027|Etafilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
1034221|NCT00733291|O2|Outcome|Nelfilcon A / No Soak|Nelfilcon A contact lenses inserted directly out of the blister package
1034222|NCT00733291|O1|Outcome|Nelfilcon A / FID 107027|Nelfilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
1034223|NCT00733291|O4|Outcome|Etafilcon A / no Soak|Etafilcon A contact lenses inserted directly out of the blister package
1034224|NCT00733291|O3|Outcome|Etafilcon A / FID 107027|Etafilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
1034225|NCT00733291|O2|Outcome|Nelfilcon A / no Soak|Nelfilcon A contact lenses inserted directly out of the blister package
1034226|NCT00733291|O1|Outcome|Nelfilcon A / FID 107027|Nelfilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
1034227|NCT00733291|E4|Reported Event|Etafilcon / no Soak|Etafilcon A contact lenses inserted directly out of the blister package
1034228|NCT00733291|E3|Reported Event|Etafilcon A / FID 107027|Etafilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
1034229|NCT00733291|E2|Reported Event|Nelfilcon A / no Soak|Nelfilcon A contact lenses inserted directly out of the blister package
1034230|NCT00733291|E1|Reported Event|Nelfilcon A / FID 107027|Nelfilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion
1034231|NCT00733278|B1|Baseline|IUD Placement|
1034232|NCT00733278|P1|Participant Flow|Copper IUD|Women undergoing elective C-section who request long-term contraception with Copper IUD.
1034233|NCT00733278|O1|Outcome|IUD Strings|Visibility of IUD strings within the vagina at all times.
1034234|NCT00733278|O1|Outcome|IUD Placement|IUD placement following removal of placenta at time of elective C-section
1034235|NCT00733278|E1|Reported Event|Copper IUD|Women undergoing elective C-section who request long-term contraception with Copper IUD.
1034236|NCT00733226|B3|Baseline|Total|Total of all reporting groups
1034237|NCT00733226|B2|Baseline|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
1034238|NCT00733226|B1|Baseline|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
1034239|NCT00733226|P2|Participant Flow|Placebo Group|The children received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
1034240|NCT00733226|P1|Participant Flow|Broncho-Vaxom Group|The children received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
1034241|NCT00733226|O2|Outcome|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
1034242|NCT00733226|O1|Outcome|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
1034243|NCT00733226|O2|Outcome|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
1034244|NCT00733226|O1|Outcome|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
1034245|NCT00733226|O2|Outcome|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
1034246|NCT00733226|O1|Outcome|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
1034247|NCT00733226|O2|Outcome|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
1034248|NCT00733226|O1|Outcome|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
1034249|NCT00733226|O2|Outcome|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
1034250|NCT00733226|O1|Outcome|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
1034356|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
1034357|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
1034657|NCT00732225|O1|Outcome|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
1034251|NCT00733226|O2|Outcome|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
1034252|NCT00733226|O1|Outcome|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
1034253|NCT00733226|E2|Reported Event|Placebo Group|This group consists of 40 children with recurrent wheezing who received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
1034254|NCT00733226|E1|Reported Event|Broncho-Vaxom Group|This group consists of 35 children with recurrent wheezing who received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
1034255|NCT00733135|B1|Baseline|Study Cohort|All participants were treated with SilverHawk™ /TurboHawk™ plaque excision systems, with the SpiderFX™ embolic protection device placed distally.
1034256|NCT00733135|P1|Participant Flow|Study Cohort|All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.
1034257|NCT00733135|O1|Outcome|Study Cohort|All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.
1034258|NCT00733135|O1|Outcome|Study Cohort|All participants were treated with SilverHawk™ /TurboHawk™ plaque excision systems, with the SpiderFX™ embolic protection device placed distally.
1034259|NCT00733135|O1|Outcome|Study Cohort|All participants were treated with SilverHawk™ /TurboHawk™ plaque excision systems, with the SpiderFX™ embolic protection device placed distally.
1034260|NCT00733135|O1|Outcome|Study Cohort|All participants were treated with SilverHawk/TurboHawk™ plaque excision systems with the SpiderFX™ embolic protection device placed distally.
1034261|NCT00733135|O1|Outcome|Study Cohort|All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.
1034262|NCT00733135|O1|Outcome|Study Cohort|All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.
1034263|NCT00733135|E1|Reported Event|Study Cohort|All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.
1034264|NCT00733096|B4|Baseline|Total|Total of all reporting groups
1034265|NCT00733096|B3|Baseline|Saline|Two epidural saline injections
1034266|NCT00733096|B2|Baseline|Etanercept|Two epidural etanercept injections
1034267|NCT00733096|B1|Baseline|Steroid|Two epidural steroid injections
1034268|NCT00733096|P3|Participant Flow|Saline|Two epidural saline injections
1034269|NCT00733096|P2|Participant Flow|Etanercept|Two epidural etanercept injections
1034270|NCT00733096|P1|Participant Flow|Steroid|Two epidural steroid injections
1034271|NCT00733096|O3|Outcome|Saline|Two epidural saline injections
1034272|NCT00733096|O2|Outcome|Etanercept|Two epidural etanercept injections
1034273|NCT00733096|O1|Outcome|Steroid|Two epidural steroid injections
1034274|NCT00733096|O3|Outcome|Saline|Two epidural saline injections
1034275|NCT00733096|O2|Outcome|Etanercept|Two epidural etanercept injections
1034276|NCT00733096|O1|Outcome|Steroid|Two epidural steroid injections
1034277|NCT00733096|O3|Outcome|Saline|Two epidural saline injections
1034278|NCT00733096|O2|Outcome|Etanercept|Two epidural etanercept injections
1034279|NCT00733096|O1|Outcome|Steroid|Two epidural steroid injections
1034280|NCT00733096|O3|Outcome|Saline|Two epidural saline injections
1034281|NCT00733096|O2|Outcome|Etanercept|Two epidural etanercept injections
1034282|NCT00733096|O1|Outcome|Steroid|Two epidural steroid injections
1034283|NCT00733096|E3|Reported Event|Saline|Two epidural saline injections
1034284|NCT00733096|E2|Reported Event|Etanercept|Two epidural etanercept injections
1034285|NCT00733096|E1|Reported Event|Steroid|Two epidural steroid injections
1034286|NCT00733005|B3|Baseline|Total|Total of all reporting groups
1034287|NCT00733005|B2|Baseline|Placebo Nasal Spray|Matching placebo nasal spray
1034288|NCT00733005|B1|Baseline|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
1034289|NCT00733005|P2|Participant Flow|Placebo Nasal Spray|Matching placebo nasal spray
1034290|NCT00733005|P1|Participant Flow|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
1034291|NCT00733005|O2|Outcome|Placebo Nasal Spray|Matching placebo nasal spray
1034292|NCT00733005|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
1034293|NCT00733005|O2|Outcome|Placebo Nasal Spray|Matching placebo nasal spray
1034294|NCT00733005|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
1034295|NCT00733005|E2|Reported Event|Placebo Nasal Spray|Matching placebo nasal spray
1034296|NCT00733005|E1|Reported Event|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
1034297|NCT00732992|B3|Baseline|Total|Total of all reporting groups
1034298|NCT00732992|B2|Baseline|Sunitinib 50 mg/Day Schedule-2/1|"Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.~Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle."
1034299|NCT00732992|B1|Baseline|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
1034300|NCT00732992|P2|Participant Flow|Sunitinib 50 mg/Day Schedule-2/1|"Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.~Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle."
1034301|NCT00732992|P1|Participant Flow|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
1034302|NCT00732992|O2|Outcome|Sunitinib 50 mg/Day Schedule-2/1|"Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.~Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle."
1034303|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
1034304|NCT00732992|O1|Outcome|Sunitinib 50 mg/Day Schedule-2/1|"Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.~Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle."
1034305|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
1034306|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
1034307|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
1034308|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
1034309|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
1034310|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
1034311|NCT00732992|O1|Outcome|Sunitinib 50 mg/Day Schedule-2/1|"Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.~Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle."
1034312|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
1034313|NCT00732992|O2|Outcome|Sunitinib 50 mg/Day Schedule-2/1|"Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.~Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle."
1034314|NCT00732992|O1|Outcome|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
1034315|NCT00732992|E2|Reported Event|Sunitinib 50 mg/Day Schedule-2/1|"Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.~Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle."
1034316|NCT00732992|E1|Reported Event|Sunitinib 37.5 mg/Day Continuous Daily Dosing|Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.
1034317|NCT00732940|B3|Baseline|Total|Total of all reporting groups
1034318|NCT00732940|B2|Baseline|Belimumab SC 3X/WK|
1034319|NCT00732940|B1|Baseline|Belimumab SC Q2WKS|
1034320|NCT00732940|P2|Participant Flow|Belimumab SC 3X/WK|200 mg of belimumab (2 subcutaneous injections of 100 mg each) on days 0, 2, and 4 then 100 mg three times a week until Week 24 with option to continue receiving belimumab at the same dose through 144 week continuation period.
1034321|NCT00732940|P1|Participant Flow|Belimumab SC Q2WKS|100 mg of belimumab (1 subcutaneous injection) on days 0, 7, and 14, then every other week until Week 24 with option to continue receiving belimumab at the same dose through 144 week continuation period.
1034322|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
1034323|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
1034324|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
1034325|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
1034326|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
1034327|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
1034328|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
1034329|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
1034330|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
1034331|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
1034332|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
1034333|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
1034334|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
1034335|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
1034336|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
1034337|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
1034338|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
1034339|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
1034340|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
1034341|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
1034342|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
1034343|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
1034344|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
1034345|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
1034346|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
1034347|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
1034348|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
1034349|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
1034350|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
1034351|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
1034352|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
1034353|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
1034354|NCT00732940|O2|Outcome|Belimumab SC 3X/WK|
1034355|NCT00732940|O1|Outcome|Belimumab SC Q2WKS|
1034386|NCT00732940|E2|Reported Event|Belimumab SC 3X/WK|The 3x/wk group will receive 200 mg of belimumab (2 injections of 100 mg each) plus standard therapy on Days 0, 2, and 4 and then 100 mg (1 injection) 3 times per week thereafter.
1034387|NCT00732940|E1|Reported Event|Belimumab SC Q2WKS|The Q2wk group will receive 100 mg of belimumab (1 injection) plus standard therapy on Days 0, 7, 14, and then every 2 weeks thereafter.
1034388|NCT00732901|B3|Baseline|Total|Total of all reporting groups
1034389|NCT00732901|B2|Baseline|B (Placebo)|Placebo once daily for days 1-28
1034390|NCT00732901|B1|Baseline|A (Escitalopram)|Escitalopram: once daily 10 mg on days 1–3, 20 mg on days 4–24 and 10 mg on days 25–28
1034391|NCT00732901|P2|Participant Flow|B (Placebo)|"Placebo~Placebo: once daily for days 1-28"
1034392|NCT00732901|P1|Participant Flow|A (Escitalopram)|"Escitalopram~Escitalopram: once daily 10 mg on days 1–3, 20 mg on days 4–24 and 10 mg on days 25–28"
1034393|NCT00732901|O2|Outcome|B (Placebo)|"Placebo~Placebo: daily for days 1-28"
1034394|NCT00732901|O1|Outcome|A (Escitalopram)|"Escitalopram~Escitalopram: 10 mg daily for days 1-3, 20mg daily for days 4-24, and 10mg daily for days 25-28"
1034395|NCT00732901|O2|Outcome|B (Placebo)|"Placebo~Placebo: daily for days 1-28"
1034396|NCT00732901|O1|Outcome|A (Escitalopram)|"Escitalopram~Escitalopram: 10 mg daily for days 1-3, 20mg daily for days 4-24, and 10mg daily for days 25-28"
1034397|NCT00732901|O2|Outcome|B (Placebo)|"Placebo~Placebo: daily for days 1-28"
1034398|NCT00732901|O1|Outcome|A (Escitalopram)|"Escitalopram~Escitalopram: 10 mg daily for days 1-3, 20mg daily for days 4-24, and 10mg daily for days 25-28"
1034399|NCT00732901|E2|Reported Event|B (Placebo)|"Placebo~Placebo: once daily for days 1-28"
1034400|NCT00732901|E1|Reported Event|A (Escitalopram)|"Escitalopram~Escitalopram: once daily 10 mg on days 1–3, 20 mg on days 4–24 and 10 mg on days 25–28"
1034401|NCT00732875|B1|Baseline|Open Label Infliximab + Methotrexate|Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
1034402|NCT00732875|P1|Participant Flow|Open Label Infliximab + Methotrexate|Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
1034403|NCT00732875|O1|Outcome|Open Label Infliximab + Methotrexate|Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
1034404|NCT00732875|O1|Outcome|Open Label Infliximab + Methotrexate|Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
1034405|NCT00732875|O1|Outcome|Open Label Infliximab + Methotrexate|Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
1034406|NCT00732875|E1|Reported Event|Open Label Infliximab + Methotrexate|Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
1034407|NCT00732758|B3|Baseline|Total|Total of all reporting groups
1034408|NCT00732758|B2|Baseline|Placebo Group|"Placebo Tablet~Placebo Tablet: Placebo Tablet once daily for 6 months"
1034409|NCT00732758|B1|Baseline|Vitamin D3 Group|"Vitamin D3 1000 IU Tablet~Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months"
1034410|NCT00732758|P2|Participant Flow|Placebo Group|"Placebo Tablet~Placebo Tablet: Placebo Tablet once daily for 6 months"
1034411|NCT00732758|P1|Participant Flow|Vitamin D3 Group|"Vitamin D3 1000 IU Tablet~Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months"
1034412|NCT00732758|O2|Outcome|Placebo Group|"Placebo Tablet~Placebo Tablet: Placebo Tablet once daily for 6 months"
1034413|NCT00732758|O1|Outcome|Vitamin D3 Group|"Vitamin D3 1000 IU Tablet~Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months"
1034414|NCT00732758|O2|Outcome|Placebo Group|"Placebo Tablet~Placebo Tablet: Placebo Tablet once daily for 6 months"
1034415|NCT00732758|O1|Outcome|Vitamin D3 Group|"Vitamin D3 1000 IU Tablet~Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months"
1034416|NCT00732758|O2|Outcome|Placebo Group|"Placebo Tablet~Placebo Tablet: Placebo Tablet once daily for 6 months"
1034417|NCT00732758|O1|Outcome|Vitamin D3 Group|"Vitamin D3 1000 IU Tablet~Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months"
1034418|NCT00732758|O2|Outcome|Placebo Group|"Placebo Tablet~Placebo Tablet: Placebo Tablet once daily for 6 months"
1034419|NCT00732758|O1|Outcome|Vitamin D3 Group|"Vitamin D3 1000 IU Tablet~Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months"
1034420|NCT00732758|E2|Reported Event|Placebo Group|"Placebo Tablet~Placebo Tablet: Placebo Tablet once daily for 6 months"
1034421|NCT00732758|E1|Reported Event|Vitamin D3 Group|"Vitamin D3 1000 IU Tablet~Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months"
1034422|NCT00732680|B1|Baseline|Botulinum Toxin Type A|Treatment will be in the form of 10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.
1034423|NCT00732680|P1|Participant Flow|Botulinum Toxin Type A|Treatment will be in the form of 10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.
1034424|NCT00732680|O1|Outcome|Botulinum Toxin Type A|Treatment will be in the form of 10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.
1034425|NCT00732680|E1|Reported Event|Botulinum Toxin Type A|Treatment will be in the form of 10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.
1034426|NCT00732654|B4|Baseline|Total|Total of all reporting groups
1034427|NCT00732654|B3|Baseline|SLIT Group|"These subjects will have a dose escalation of the milk protein extract given sublingually. After dose escalation, they will continue on the sublingual daily maintenance dose for approximately one year.~Milk Protein Extract Immunotherapy : Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years."
1034456|NCT00732641|O1|Outcome|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
1034457|NCT00732641|O2|Outcome|No Treatment|Participants were observed and received no treatment
1034458|NCT00732641|O1|Outcome|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
1034460|NCT00732641|O1|Outcome|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
1034461|NCT00732641|O2|Outcome|No Treatment|Participants were observed and received no treatment
1034428|NCT00732654|B2|Baseline|OITB Group|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 1000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks."
1034429|NCT00732654|B1|Baseline|OITA Group|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 2000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks."
1034430|NCT00732654|P3|Participant Flow|SLIT/ OIT A|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 1000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks."
1034431|NCT00732654|P2|Participant Flow|SLIT/OIT B|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 2000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks."
1034432|NCT00732654|P1|Participant Flow|SLIT|"These subjects will have a dose escalation of the milk protein extract given sublingually. After dose escalation, they will continue on the sublingual daily maintenance dose for approximately one year.~Milk Protein Extract Immunotherapy : Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years."
1034433|NCT00732654|O3|Outcome|SLIT/ OIT A|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 2000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Powder Immunotherapy goal dose 2000 mg/day: Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years."
1034434|NCT00732654|O2|Outcome|SLIT/OIT B|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 1000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Powder Immunotherapy goal dose 1000mg/day: Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years."
1034435|NCT00732654|O1|Outcome|SLIT|"These subjects will have a dose escalation of the milk protein extract given sublingually. After dose escalation, they will continue on the sublingual daily maintenance dose for approximately one year.~Milk Protein Extract Immunotherapy : Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Protein Extract Immunotherapy goal of 7mg/day: Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years."
1034436|NCT00732654|O3|Outcome|SLIT/ OIT A|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 2000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Powder Immunotherapy goal dose 2000 mg/day: Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years."
1034437|NCT00732654|O2|Outcome|SLIT/OIT B|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 1000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Powder Immunotherapy goal dose 1000mg/day: Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years."
1034438|NCT00732654|O1|Outcome|SLIT|"These subjects will have a dose escalation of the milk protein extract given sublingually. After dose escalation, they will continue on the sublingual daily maintenance dose for approximately one year.~Milk Protein Extract Immunotherapy : Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Protein Extract Immunotherapy goal of 7mg/day: Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years."
1040069|NCT00718081|O2|Outcome|Sufentanil NanoTab 15 mcg|
1034439|NCT00732654|O3|Outcome|SLIT/ OIT A|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 2000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Powder Immunotherapy goal dose 2000 mg/day: Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years."
1034440|NCT00732654|O2|Outcome|SLIT/OIT B|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 1000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Powder Immunotherapy goal dose 1000mg/day: Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years."
1034441|NCT00732654|O1|Outcome|SLIT|"These subjects will have a dose escalation of the milk protein extract given sublingually. After dose escalation, they will continue on the sublingual daily maintenance dose for approximately one year.~Milk Protein Extract Immunotherapy : Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Protein Extract Immunotherapy goal of 7mg/day: Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years."
1034442|NCT00732654|O3|Outcome|SLIT/ OIT A|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 2000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Powder Immunotherapy goal dose 2000 mg/day: Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years."
1034443|NCT00732654|O2|Outcome|SLIT/OIT B|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 1000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Powder Immunotherapy goal dose 1000mg/day: Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years."
1034444|NCT00732654|O1|Outcome|SLIT|"These subjects will have a dose escalation of the milk protein extract given sublingually. After dose escalation, they will continue on the sublingual daily maintenance dose for approximately one year.~Milk Protein Extract Immunotherapy : Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy goal of 4mg/day: Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.~Milk Protein Extract Immunotherapy goal of 7mg/day: Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years."
1034445|NCT00732654|E3|Reported Event|SLIT Group|"These subjects will have a dose escalation of the milk protein extract given sublingually. After dose escalation, they will continue on the sublingual daily maintenance dose for approximately one year.~Milk Protein Extract Immunotherapy : Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years."
1034446|NCT00732654|E2|Reported Event|OITB Group|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 1000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks."
1034447|NCT00732654|E1|Reported Event|OITA Group|"These subjects will start with a dose escalation of the milk protein extract given sublingually, and then will switch to milk powder given orally and will undergo a dose escalation for a goal of 2000 mg. After dose escalation, they will continue on the oral daily maintenance dose for approximately one year.~Milk Powder Immunotherapy : Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.~Milk Protein Extract Immunotherapy : Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks."
1034448|NCT00732641|B3|Baseline|Total|Total of all reporting groups
1034449|NCT00732641|B2|Baseline|No Treatment|Participants were observed and received no treatment
1034450|NCT00732641|B1|Baseline|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
1034451|NCT00732641|P2|Participant Flow|No Treatment|Participants were observed and received no treatment
1034452|NCT00732641|P1|Participant Flow|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
1034453|NCT00732641|O2|Outcome|No Treatment|Participants were observed and received no treatment
1034454|NCT00732641|O1|Outcome|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
1034455|NCT00732641|O2|Outcome|No Treatment|Participants were observed and received no treatment
1034459|NCT00732641|O2|Outcome|No Treatment|Participants were observed and received no treatment
1034462|NCT00732641|O1|Outcome|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
1034463|NCT00732641|O2|Outcome|No Treatment|Participants were observed and received no treatment
1034464|NCT00732641|O1|Outcome|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
1034465|NCT00732641|O2|Outcome|No Treatment|Participants were observed and received no treatment
1034466|NCT00732641|O1|Outcome|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
1034467|NCT00732641|E2|Reported Event|No Treatment|Participants were observed and received no treatment
1034468|NCT00732641|E1|Reported Event|Peginterferon α-2b|Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
1034469|NCT00732615|B3|Baseline|Total|Total of all reporting groups
1034470|NCT00732615|B2|Baseline|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily
1034471|NCT00732615|B1|Baseline|Placebo|Matching Placebo: Placebo for subcutaneous injection
1034472|NCT00732615|P2|Participant Flow|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily
1034473|NCT00732615|P1|Participant Flow|Placebo|Matching Placebo: Placebo for subcutaneous injection
1034474|NCT00732615|O2|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily
1034475|NCT00732615|O1|Outcome|Placebo|Matching Placebo: Placebo for subcutaneous injection
1034476|NCT00732615|O2|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily
1034477|NCT00732615|O1|Outcome|Placebo|Matching Placebo: Placebo for subcutaneous injection
1034478|NCT00732615|O2|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily
1034479|NCT00732615|O1|Outcome|Placebo|Matching Placebo: Placebo for subcutaneous injection
1034480|NCT00732615|O2|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
1034481|NCT00732615|O1|Outcome|Placebo|Matching Placebo: Placebo for subcutaneous injection
1034482|NCT00732615|E2|Reported Event|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily
1034483|NCT00732615|E1|Reported Event|Placebo|Matching Placebo: Placebo for subcutaneous injection
1034484|NCT00732472|B5|Baseline|Total|Total of all reporting groups
1034485|NCT00732472|B4|Baseline|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
1034486|NCT00732472|B3|Baseline|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
1034487|NCT00732472|B2|Baseline|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
1034488|NCT00732472|B1|Baseline|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
1034489|NCT00732472|P4|Participant Flow|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
1034490|NCT00732472|P3|Participant Flow|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
1034491|NCT00732472|P2|Participant Flow|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
1034492|NCT00732472|P1|Participant Flow|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
1034493|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
1034494|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
1034495|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
1034496|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
1034497|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
1034498|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
1034499|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
1034500|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
1034501|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
1034744|NCT00732069|E1|Reported Event|Ramipril|All subjects receiving ramipril
1034502|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
1034503|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
1034504|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
1034505|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
1034506|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
1034507|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
1034508|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
1034509|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
1034510|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
1034511|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
1034512|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
1034513|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
1034514|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
1034515|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
1034516|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
1034517|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
1034518|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
1034519|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
1034520|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
1034521|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
1034522|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
1034523|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
1034524|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
1034525|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
1034526|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
1034527|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
1034528|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
1034529|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
1034530|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
1034531|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
1034532|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
1034533|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
1034655|NCT00732225|O3|Outcome|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
1034534|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
1034535|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
1034536|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
1034537|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
1034538|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC19 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
1034539|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
1034540|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
1034541|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
1034542|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
1034543|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
1034544|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
1034545|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
1034546|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
1034547|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
1034548|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
1034549|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
1034550|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
1034551|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
1034552|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
1034553|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
1034554|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
1034555|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
1034556|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
1034557|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
1034558|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
1034559|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
1034560|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
1034561|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
1034562|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
1034563|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
1034564|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
1034565|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
1034692|NCT00732212|O4|Outcome|Doppler Variceal Patients|Rate of Doppler assisted variceal patients who had complications within 30 days.
1034566|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
1034567|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
1034568|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
1034569|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
1034570|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
1034571|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
1034572|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
1034573|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
1034574|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
1034575|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
1034576|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
1034577|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
1034578|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
1034579|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
1034580|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
1034581|NCT00732472|O4|Outcome|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
1034582|NCT00732472|O3|Outcome|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
1034583|NCT00732472|O2|Outcome|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
1034584|NCT00732472|O1|Outcome|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
1034585|NCT00732472|E4|Reported Event|Cohort 3 UMEC 1000 µg|Participants received four inhaled doses of UMEC 250 μg (equivalent to 1000 μg) formulated with MgSt QD for 7 days via a DPI.
1034586|NCT00732472|E3|Reported Event|Cohort 2 UMEC 250 µg in Error|Participants received a single inhaled dose of UMEC 250 μg formulated with MgSt QD for 7 days via a DPI. These participants were to have been randomized to receive UMEC 1000 µg; however, they received UMEC 250 µg in error.
1034587|NCT00732472|E2|Reported Event|Cohort 1 UMEC 250 µg|Participants received a single inhaled dose of umeclidinium (UMEC) 250 micrograms (µg) formulated with magnesium stearate (MgSt) QD for 7 days via a DPI.
1034588|NCT00732472|E1|Reported Event|Placebo|Participants received either a single inhaled dose or four inhaled doses of matching placebo once daily (QD) for 7 days via a dry powder inhaler (DPI).
1034589|NCT00732381|B3|Baseline|Total|Total of all reporting groups
1034590|NCT00732381|B2|Baseline|Placebo Nasal Spray|Matching placebo nasal spray
1034591|NCT00732381|B1|Baseline|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
1034592|NCT00732381|P2|Participant Flow|Placebo Nasal Spray|Matching placebo nasal spray
1034593|NCT00732381|P1|Participant Flow|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
1034594|NCT00732381|O2|Outcome|Placebo Nasal Spray|Matching placebo nasal spray
1034595|NCT00732381|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
1034596|NCT00732381|O2|Outcome|Placebo Nasal Spray|Matching placebo nasal spray
1034597|NCT00732381|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
1034598|NCT00732381|E2|Reported Event|Placebo Nasal Spray|Matching placebo nasal spray
1034599|NCT00732381|E1|Reported Event|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
1034610|NCT00732238|P1|Participant Flow|New Catheter Arm|"Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy.~Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse."
1034611|NCT00732238|O2|Outcome|Existing Catheter Arm|"Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy.~Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter."
1034656|NCT00732225|O2|Outcome|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
1034747|NCT00732030|O1|Outcome|AcrySof Toric T3|Each enrolled eye receives AcrySof Toric SN60T3 IOL
1034600|NCT00732303|B1|Baseline|Single Arm Assignment|"Pemetrexed (Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles~Radiation will start between days –1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.~Pemetrexed: Pemetrexed(Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles~Radiation Therapy:~Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks."
1034601|NCT00732303|P1|Participant Flow|Single Arm Assignment|"Pemetrexed (Alimta) 500mg/m^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x3 cycles~Radiation will start between days –1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.~Pemetrexed: Pemetrexed(Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles~Radiation Therapy:~Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks."
1034602|NCT00732303|O1|Outcome|Single Arm Assignment|"Pemetrexed (Alimta) 500mg/m^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x3 cycles~Radiation will start between days –1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.~Pemetrexed: Pemetrexed(Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles~Radiation Therapy:~Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks."
1034603|NCT00732303|O1|Outcome|Single Arm Assignment|"Pemetrexed (Alimta) 500mg/m^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x3 cycles~Radiation will start between days –1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.~Pemetrexed: Pemetrexed(Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles~Radiation Therapy:~Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks."
1034604|NCT00732303|O1|Outcome|Single Arm Assignment|"Pemetrexed (Alimta) 500mg/m^2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x3 cycles~Radiation will start between days –1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.~Pemetrexed: Pemetrexed(Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles~Radiation Therapy:~Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks."
1034605|NCT00732303|E1|Reported Event|Pemetrexed\Radiation|"Pemetrexed (Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles~Radiation will start between days –1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks.~Pemetrexed: Pemetrexed(Alimta) 500mg/m2 administered intravenously over approximately 10-minutes on Day 1 of a 21-day cycle x 3 cycles~Radiation Therapy:~Radiation will start between days -1 to 2 from day 1 of cycle 1. Day 1 radiotherapy must be a Monday, Tuesday, or Wednesday.~The planned radiation dose is 60 Gy in 2.0 Gy fractions. The entire PTV, including primary tumor and areas of known nodal disease, shall receive 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks."
1034606|NCT00732238|B3|Baseline|Total|Total of all reporting groups
1034607|NCT00732238|B2|Baseline|Existing Catheter Arm|"Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy.~Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter."
1034608|NCT00732238|B1|Baseline|New Catheter Arm|"Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy.~Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse."
1034609|NCT00732238|P2|Participant Flow|Existing Catheter Arm|"Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy.~Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter."
1034653|NCT00732225|O5|Outcome|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
1034654|NCT00732225|O4|Outcome|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
1034612|NCT00732238|O1|Outcome|New Catheter Arm|"Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy.~Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse."
1034613|NCT00732238|O2|Outcome|Arm 2|"Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy.~Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter."
1034614|NCT00732238|O1|Outcome|Arm 1|"Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy.~Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse."
1034615|NCT00732238|E2|Reported Event|Arm 2|"Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy.~Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter."
1034616|NCT00732238|E1|Reported Event|Arm 1|"Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy.~Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse."
1034617|NCT00732225|B6|Baseline|Total|Total of all reporting groups
1034618|NCT00732225|B5|Baseline|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
1034619|NCT00732225|B4|Baseline|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
1034620|NCT00732225|B3|Baseline|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
1034621|NCT00732225|B2|Baseline|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
1034622|NCT00732225|B1|Baseline|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
1034623|NCT00732225|P5|Participant Flow|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
1034624|NCT00732225|P4|Participant Flow|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
1034625|NCT00732225|P3|Participant Flow|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
1034626|NCT00732225|P2|Participant Flow|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
1034627|NCT00732225|P1|Participant Flow|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
1034628|NCT00732225|O5|Outcome|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
1034629|NCT00732225|O4|Outcome|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
1034630|NCT00732225|O3|Outcome|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
1034631|NCT00732225|O2|Outcome|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
1034632|NCT00732225|O1|Outcome|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
1034633|NCT00732225|O5|Outcome|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
1034634|NCT00732225|O4|Outcome|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
1034635|NCT00732225|O3|Outcome|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
1034636|NCT00732225|O2|Outcome|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
1034637|NCT00732225|O1|Outcome|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
1034638|NCT00732225|O5|Outcome|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
1034639|NCT00732225|O4|Outcome|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
1034640|NCT00732225|O3|Outcome|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
1034641|NCT00732225|O2|Outcome|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
1034642|NCT00732225|O1|Outcome|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
1034643|NCT00732225|O5|Outcome|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
1034644|NCT00732225|O4|Outcome|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
1034645|NCT00732225|O3|Outcome|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
1034646|NCT00732225|O2|Outcome|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
1034647|NCT00732225|O1|Outcome|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
1034648|NCT00732225|O5|Outcome|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
1034649|NCT00732225|O4|Outcome|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
1034650|NCT00732225|O3|Outcome|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
1034651|NCT00732225|O2|Outcome|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
1034652|NCT00732225|O1|Outcome|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
1034658|NCT00732225|O5|Outcome|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
1034659|NCT00732225|O4|Outcome|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
1034660|NCT00732225|O3|Outcome|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
1034661|NCT00732225|O2|Outcome|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
1034662|NCT00732225|O1|Outcome|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
1034663|NCT00732225|O5|Outcome|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
1034664|NCT00732225|O4|Outcome|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
1034665|NCT00732225|O3|Outcome|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
1034666|NCT00732225|O2|Outcome|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
1034667|NCT00732225|O1|Outcome|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
1034668|NCT00732225|E5|Reported Event|AmviscPlus|Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
1034669|NCT00732225|E4|Reported Event|Healon5|AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
1034670|NCT00732225|E3|Reported Event|BioVisc|Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
1034671|NCT00732225|E2|Reported Event|DuoVisc|Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
1034672|NCT00732225|E1|Reported Event|DisCoVisc|Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
1034673|NCT00732212|B5|Baseline|Total|Total of all reporting groups
1034674|NCT00732212|B4|Baseline|Doppler Variceal Group|Doppler variceal treatment patient characteristics, risk factors and the primary outcome (rebleed with 30 days) were analyzed. Each specified variable and 30 day lesion rebleeding were compared between the two treatment groups separately by time period using the Chi-Square or Fisher exact tests (for categorical variables) or the Wilcoxon rank sum test (for continuous variables).
1034675|NCT00732212|B3|Baseline|Standard Variceal Group|Standard variceal treatment patient characteristics, risk factors and the primary outcome (rebleed with 30 days) were analyzed. Each specified variable and 30 day lesion rebleeding were compared between the two treatment groups separately by time period using the Chi-Square or Fisher exact tests (for categorical variables) or the Wilcoxon rank sum test (for continuous variables).
1034676|NCT00732212|B2|Baseline|Doppler Non-variceal Group|Doppler non-variceal treatment patient characteristics, risk factors and the primary outcome (rebleed with 30 days) were analyzed. Each specified variable and 30 day lesion rebleeding were compared between the two treatment groups separately by time period using the Chi-Square or Fisher exact tests (for categorical variables) or the Wilcoxon rank sum test (for continuous variables).
1034677|NCT00732212|B1|Baseline|Standard Non-variceal Group|Standard non-variceal treatment patient characteristics, risk factors and the primary outcome (rebleed with 30 days) were analyzed. Each specified variable and 30 day lesion rebleeding were compared between the two treatment groups separately by time period using the Chi-Square or Fisher exact tests (for categorical variables) or the Wilcoxon rank sum test (for continuous variables).
1034678|NCT00732212|P2|Participant Flow|Standard Endoscopic Hemostasis|"Standard, visually guided endoscopic hemostasis based on visual cues of stigmata of hemorrhage and endoscopic control of bleeding or treatment of the stigmata according to current guidelines~Standard endoscopic hemostasis: Per current treatment guidelines for non-variceal UGI lesions - based upon stigmata of hemorrhage & visual cues for risk stratification and completion of endoscopic treatment."
1034679|NCT00732212|P1|Participant Flow|Doppler Endoscopic Probe Assisted Hemostasis|"In addition to stigmata of hemorrhage and visual cues, Doppler endoscopic probe will be used for detection of blood flow before and after standard endoscopic hemostasis. If residual blood flow in the lesion is found after standard treatment, further endoscopic treatment will be applied as deemed safe by the investigator-endoscopist.~Doppler endoscopic ultrasound probe is used for blood flow detection"
1034680|NCT00732212|O4|Outcome|Doppler Variceal Group|Length of hospitalization days in Doppler assisted variceal patients.
1034681|NCT00732212|O3|Outcome|Standard Variceal Group|Length of hospitalization days in standard visually guided hemostasis variceal patients.
1034682|NCT00732212|O2|Outcome|Doppler Non-variceal Group|Length of hospitalization days in Doppler assisted non-variceal patients.
1034683|NCT00732212|O1|Outcome|Standard Non-variceal Group|Length of hospitalization days in standard visually guided hemostasis non-variceal patients.
1034684|NCT00732212|O4|Outcome|Doppler Variceal Group|RBC units of transfusion post-randomization in Doppler assisted variceal patients.
1034685|NCT00732212|O3|Outcome|Standard Variceal Group|RBC units of transfusion post-randomization in standard visually guided hemostasis variceal patients.
1034686|NCT00732212|O2|Outcome|Doppler Non-variceal Group|RBC units of transfusion post-randomization in Doppler assisted non-variceal patients.
1034687|NCT00732212|O1|Outcome|Standard Non-variceal Group|RBC units of transfusion post-randomization in standard visually guided hemostasis non-variceal patients.
1034688|NCT00732212|O4|Outcome|Doppler Variceal Group|Number of deaths in Doppler assisted variceal patients within 30 days from a co-morbid condition, bleeding, or another cause.
1034689|NCT00732212|O3|Outcome|Standard Variceal Group|Number of deaths in standard visually guided hemostasis variceal patients within 30 days from a co-morbid condition, bleeding, or another cause.
1034690|NCT00732212|O2|Outcome|Doppler Non-variceal Group|Number of deaths in Doppler assisted non-variceal patients within 30 days from a co-morbid condition, bleeding, or another cause.
1034691|NCT00732212|O1|Outcome|Standard Non-variceal Group|Number of deaths in standard visually guided hemostasis non-variceal patients within 30 days from a co-morbid condition, bleeding, or another cause.
1034693|NCT00732212|O3|Outcome|Standard Variceal Group|Rate of standard visually guided hemostasis variceal patients who had complications within 30 days.
1034694|NCT00732212|O2|Outcome|Doppler Non-variceal Group|Rate of Doppler assisted non-variceal patients who had complications within 30 days.
1034695|NCT00732212|O1|Outcome|Standard Non-variceal Group|Rate of standard visually guided hemostasis non-variceal patients who had complications within 30 days.
1034696|NCT00732212|O4|Outcome|Doppler Variceal Group|30 day rate of surgery in Doppler assisted variceal patients.
1034697|NCT00732212|O3|Outcome|Standard Variceal Group|30 day rate of surgery in standard visually guided hemostasis variceal patients.
1034698|NCT00732212|O2|Outcome|Doppler Non-variceal Group|30 day rate of surgery in Doppler assisted non-variceal patients.
1034699|NCT00732212|O1|Outcome|Standard Non-variceal Group|30 day rate of surgery in standard visually guided hemostasis non-variceal patients.
1034700|NCT00732212|O4|Outcome|Doppler Variceal Group|30 day rebleeding rate in Doppler assisted variceal patients.
1034701|NCT00732212|O3|Outcome|Standard Variceal Group|30 day rebleeding rate in standard variceal visually guided hemostasis patients.
1034702|NCT00732212|O2|Outcome|Doppler Non-variceal Group|30 day rebleeding rate in Doppler assisted non-variceal patients.
1034703|NCT00732212|O1|Outcome|Standard Non-variceal Group|30 day rebleeding rate in standard non-variceal visually guided hemostasis patients.
1034704|NCT00732212|E4|Reported Event|Doppler Variceal Group|Serious adverse events in Doppler variceal visually guided hemostasis patients.
1034705|NCT00732212|E3|Reported Event|Standard Variceal Group|Serious adverse events in standard variceal visually guided hemostasis patients.
1034706|NCT00732212|E2|Reported Event|Doppler Non-variceal Group|Serious adverse events in Doppler non-variceal patients.
1034707|NCT00732212|E1|Reported Event|Standard Non-variceal Group|Serious adverse events in standard non-variceal visually guided hemostasis patients.
1034708|NCT00732160|B5|Baseline|Total|Total of all reporting groups
1034709|NCT00732160|B4|Baseline|LS-A/V; HS-A/V|Low Sodium diet- Aldosterone then Vehicle High Sodium diet- Aldosterone then Vehicle
1034710|NCT00732160|B3|Baseline|LS-V/A; HS-V/A|Low Sodium diet- Vehicle then Aldosterone High Sodium diet- Vehicle then Aldosterone
1034711|NCT00732160|B2|Baseline|HS-A/V; LS-A/V|High Sodium diet- Aldosterone then Vehicle Low Sodium diet- Aldosterone then Vehicle
1034712|NCT00732160|B1|Baseline|HS-V/A; LS-V/A|High Sodium diet- Vehicle then Aldosterone Low Sodium diet- Vehicle then Aldosterone
1034713|NCT00732160|P4|Participant Flow|LS-A/V; HS-A/V|Low Sodium diet- Aldosterone then Vehicle High Sodium diet- Aldosterone then Vehicle
1034714|NCT00732160|P3|Participant Flow|LS-V/A; HS-V/A|Low Sodium diet- Vehicle then Aldosterone High Sodium diet- Vehicle then Aldosterone
1034715|NCT00732160|P2|Participant Flow|HS-A/V; LS-A/V|High Sodium diet- Aldosterone then Vehicle Low Sodium diet- Aldosterone then Vehicle
1034716|NCT00732160|P1|Participant Flow|HS-V/A; LS-V/A|High Sodium diet- Vehicle then Aldosterone Low Sodium diet- Vehicle then Aldosterone
1034717|NCT00732160|O4|Outcome|Aldosterone, LS|Aldosterone Infusion, Low Salt diet
1034718|NCT00732160|O3|Outcome|Aldosterone, HS|Aldosterone Infusion, High Salt diet
1034719|NCT00732160|O2|Outcome|Vehicle, LS|Vehicle Infusion, Low Salt diet
1034720|NCT00732160|O1|Outcome|Vehicle, HS|Vehicle Infusion, High Salt diet
1034721|NCT00732160|O4|Outcome|Aldosterone, LS|Aldosterone Infusion, Low Salt diet
1034722|NCT00732160|O3|Outcome|Aldosterone, HS|Aldosterone Infusion, High Salt diet
1034723|NCT00732160|O2|Outcome|Vehicle, LS|Vehicle Infusion, Low Salt diet
1034724|NCT00732160|O1|Outcome|Vehicle, HS|Vehicle Infusion, High Salt diet
1034725|NCT00732160|E4|Reported Event|Aldosterone, LS|Aldosterone Infusion, Low Salt diet
1034726|NCT00732160|E3|Reported Event|Aldosterone, HS|Aldosterone Infusion, High Salt diet
1034727|NCT00732160|E2|Reported Event|Vehicle, LS|Vehicle Infusion, Low Salt diet
1034728|NCT00732160|E1|Reported Event|Vehicle, HS|Vehicle Infusion, High Salt diet
1034729|NCT00732069|B1|Baseline|All Study Participants|After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
1034730|NCT00732069|P6|Participant Flow|Valsartan, Ramipril, Then Placebo|Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
1034731|NCT00732069|P5|Participant Flow|Ramipril, Valsartan, Then Placebo|Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
1034732|NCT00732069|P4|Participant Flow|Valsartan, Then Placebo, Then Ramipril|Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
1034733|NCT00732069|P3|Participant Flow|Ramipril, Then Placebo, Then Valsartan|Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
1034734|NCT00732069|P2|Participant Flow|Placebo, Valsartan, Then Ramipril|Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
1034735|NCT00732069|P1|Participant Flow|Placebo, Then Ramipril, Then Valsartan|Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences.
1034736|NCT00732069|O3|Outcome|Placebo|After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
1034737|NCT00732069|O2|Outcome|Valsartan|After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
1034738|NCT00732069|O1|Outcome|Ramipril|After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
1034739|NCT00732069|O3|Outcome|Placebo|After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
1034740|NCT00732069|O2|Outcome|Valsartan|After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
1034741|NCT00732069|O1|Outcome|Ramipril|After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
1034742|NCT00732069|E3|Reported Event|Placebo|All subjects receiving placebo
1034743|NCT00732069|E2|Reported Event|Valsartan|All subjects receiving valsartan
1034745|NCT00732030|B1|Baseline|AcrySof Toric T3|Each enrolled eye receives AcrySof Toric SN60T3 IOL
1034746|NCT00732030|P1|Participant Flow|AcrySof Toric T3|Each enrolled eye receives AcrySof Toric SN60T3 IOL
1034800|NCT00731874|B3|Baseline|Total|Total of all reporting groups
1034748|NCT00732030|O1|Outcome|AcrySof Toric T3|Each enrolled eye receives AcrySof Toric SN60T3 IOL
1034749|NCT00732030|O1|Outcome|AcrySof Toric T3|Each enrolled eye receives AcrySof Toric SN60T3 IOL
1034750|NCT00732030|O1|Outcome|AcrySof Toric T3|Each enrolled eye receives AcrySof Toric SN60T3 IOL
1034751|NCT00732030|E1|Reported Event|AcrySof Toric T3|Each enrolled eye receives AcrySof Toric SN60T3 IOL
1034752|NCT00731939|B1|Baseline|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034753|NCT00731939|P1|Participant Flow|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034754|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034755|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034756|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034757|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034758|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034759|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034760|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034761|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034762|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034763|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034764|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034765|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034766|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034767|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034768|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034769|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034770|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034771|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034772|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034773|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034839|NCT00731783|O2|Outcome|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
1037658|NCT00724594|P2|Participant Flow|Control Infant|Infants treated with saline
1034774|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1084264|NCT00605085|O2|Outcome|Placebo|Placebo
1034775|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034776|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034777|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034778|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034779|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034780|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034781|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034782|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034783|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034784|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034785|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034786|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034787|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034788|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034789|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034790|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034791|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034792|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034793|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034794|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034795|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034796|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034797|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034798|NCT00731939|O1|Outcome|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1034840|NCT00731783|O1|Outcome|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
1034799|NCT00731939|E1|Reported Event|Titan® OTR IPP|"Subjects implanted with Titan® One Touch Release (OTR) Inflatable Penile Prosthesis (IPP)~Inflatable Penile Prosthesis : Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction."
1084265|NCT00605085|O1|Outcome|IC51|IC51
1034801|NCT00731874|B2|Baseline|Arm 2 (Target Tacrolimus 3 to 5 ng/mL)|"Target tacrolimus trough concentration of 3 to 5 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
1034802|NCT00731874|B1|Baseline|Arm 1 (Target Tacrolimus 6 to 8 ng/mL)|"Target tacrolimus trough concentration of 6 to 8 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
1034803|NCT00731874|P2|Participant Flow|Arm 2 (Target Tacrolimus 3 to 5 ng/mL)|"Target tacrolimus trough concentration of 3 to 5 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
1034804|NCT00731874|P1|Participant Flow|Arm 1 (Target Tacrolimus 6 to 8 ng/mL)|"Target tacrolimus trough concentration of 6 to 8 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
1034805|NCT00731874|O2|Outcome|Arm 2 (Target Tacrolimus 3 to 5 ng/mL)|"Target tacrolimus trough concentration of 3 to 5 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
1034806|NCT00731874|O1|Outcome|Arm 1 (Target Tacrolimus 6 to 8 ng/mL)|"Target tacrolimus trough concentration of 6 to 8 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
1034807|NCT00731874|O2|Outcome|Arm 2 (Target Tacrolimus 3 to 5 ng/mL)|"Target tacrolimus trough concentration of 3 to 5 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
1034808|NCT00731874|O1|Outcome|Arm 1 (Target Tacrolimus 6 to 8 ng/mL)|"Target tacrolimus trough concentration of 6 to 8 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
1034809|NCT00731874|E2|Reported Event|Arm 2 (Target Tacrolimus 3 to 5 ng/mL)|"Target tacrolimus trough concentration of 3 to 5 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
1034810|NCT00731874|E1|Reported Event|Arm 1 (Target Tacrolimus 6 to 8 ng/mL)|"Target tacrolimus trough concentration of 6 to 8 ng/mL~Tacrolimus: Dosed to achieve target trough concentrations."
1034811|NCT00731822|B3|Baseline|Total|Total of all reporting groups
1034812|NCT00731822|B2|Baseline|FF/VI 400/25 µg OD|Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
1034813|NCT00731822|B1|Baseline|Placebo|Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
1034814|NCT00731822|P2|Participant Flow|FF/VI 400/25 µg OD|Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
1034815|NCT00731822|P1|Participant Flow|Placebo|Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
1034816|NCT00731822|O2|Outcome|FF/VI 400/25 µg OD|Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
1034817|NCT00731822|O1|Outcome|Placebo|Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
1034818|NCT00731822|O2|Outcome|FF/VI 400/25 µg OD|Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
1034819|NCT00731822|O1|Outcome|Placebo|Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
1034820|NCT00731822|O2|Outcome|FF/VI 400/25 µg OD|Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
1034821|NCT00731822|O1|Outcome|Placebo|Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
1034822|NCT00731822|O2|Outcome|FF/VI 400/25 µg OD|Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
1034823|NCT00731822|O1|Outcome|Placebo|Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
1034824|NCT00731822|E2|Reported Event|FF/VI 400/25 µg OD|Participants received fluticasone furoate (FF)/Vilanterol (VI [GW642444]) 400/25 micrograms (µg) OD in the morning via a DPI for 28 days.
1034825|NCT00731822|E1|Reported Event|Placebo|Participants received matching placebo once daily (OD) in the morning via a dry powder inhaler (DPI) for 28 days.
1034826|NCT00731783|B3|Baseline|Total|Total of all reporting groups
1034827|NCT00731783|B2|Baseline|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
1034828|NCT00731783|B1|Baseline|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
1034829|NCT00731783|P2|Participant Flow|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol, which includes application of 2% Mupirocin Ointment to the anterior nares twice daily for 5 days and washing with 4% Chlorhexidine liquid soap daily for 5 days.
1034830|NCT00731783|P1|Participant Flow|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen, which includes application of 2% Mupirocin Ointment to the anterior nares twice daily for 5 days and washing with 4% Chlorhexidine liquid soap daily for 5 days.
1034831|NCT00731783|O2|Outcome|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
1034832|NCT00731783|O1|Outcome|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
1034833|NCT00731783|O2|Outcome|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
1034834|NCT00731783|O1|Outcome|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
1034835|NCT00731783|O2|Outcome|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
1034836|NCT00731783|O1|Outcome|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
1034837|NCT00731783|O2|Outcome|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
1034838|NCT00731783|O1|Outcome|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
1034841|NCT00731783|O2|Outcome|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
1034842|NCT00731783|O1|Outcome|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
1037672|NCT00724594|O2|Outcome|NAC Preterm Infants|Preterm infants treated with N-acetylcysteine
1034843|NCT00731783|O2|Outcome|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
1034844|NCT00731783|O1|Outcome|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
1034845|NCT00731783|O2|Outcome|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
1034846|NCT00731783|O1|Outcome|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
1034847|NCT00731783|E2|Reported Event|Household|All members of the household (over the age of 6 months) will be asked to follow the study protocol.
1034848|NCT00731783|E1|Reported Event|Index Patient Only|Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
1034849|NCT00731731|B4|Baseline|Total|Total of all reporting groups
1034850|NCT00731731|B3|Baseline|Phase II|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. >~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
1034851|NCT00731731|B2|Baseline|Phase I, Dose Level 1|"Patients undergo 60 Gy radiotherapy and receive 400 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. >~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
1034852|NCT00731731|B1|Baseline|Phase I, Dose Level 0|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. >~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
1034853|NCT00731731|P3|Participant Flow|Phase II|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD (every day) on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
1034854|NCT00731731|P2|Participant Flow|Phase I, Dose Level 1|"Patients undergo 60 Gy radiotherapy and receive 400 mg vorinostat PO QD (every day) on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
1034855|NCT00731731|P1|Participant Flow|Phase I, Dose Level 0|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD (every day) on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
1034856|NCT00731731|O3|Outcome|Phase II|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy~>~> temozolomide: Given PO~>~> vorinostat: Given PO~>~> cognitive assessment: Ancillary studies~>~> laboratory biomarker analysis: Correlative studies"
1034857|NCT00731731|O2|Outcome|Phase I, Dose Level 1|"Patients undergo 60 Gy radiotherapy and receive 400 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy~>~> temozolomide: Given PO~>~> vorinostat: Given PO~>~> cognitive assessment: Ancillary studies~>~> laboratory biomarker analysis: Correlative studies"
1034876|NCT00731692|O2|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
1034877|NCT00731692|O1|Outcome|FTY720 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
1035027|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
1034858|NCT00731731|O1|Outcome|Phase I, Dose Level 0|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy~>~> temozolomide: Given PO~>~> vorinostat: Given PO~>~> cognitive assessment: Ancillary studies~>~> laboratory biomarker analysis: Correlative studies"
1034859|NCT00731731|O1|Outcome|Phase II|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy~>~> temozolomide: Given PO~>~> vorinostat: Given PO~>~> cognitive assessment: Ancillary studies~>~> laboratory biomarker analysis: Correlative studies"
1034860|NCT00731731|O3|Outcome|Phase II|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
1034861|NCT00731731|O2|Outcome|Phase I, Dose Level 1|"Patients undergo 60 Gy radiotherapy and receive 400 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
1034862|NCT00731731|O1|Outcome|Phase I, Dose Level 0|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
1034863|NCT00731731|O1|Outcome|Phase II|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
1034864|NCT00731731|O2|Outcome|Phase I, Dose Level 1|"Patients undergo 60 Gy radiotherapy and receive 400 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
1034865|NCT00731731|O1|Outcome|Phase I, Dose Level 0|"Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies"
1034866|NCT00731731|E3|Reported Event|Phase II|laboratory biomarker analysis: Correlative studies
1034867|NCT00731731|E2|Reported Event|Phase I, Dose Level 1|laboratory biomarker analysis: Correlative studies
1034868|NCT00731731|E1|Reported Event|Phase I, Dose Level 0|laboratory biomarker analysis: Correlative studies
1034869|NCT00731692|B4|Baseline|Total|Total of all reporting groups
1034870|NCT00731692|B3|Baseline|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
1034871|NCT00731692|B2|Baseline|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
1034872|NCT00731692|B1|Baseline|FTY720 1.25 mg to 0.5 mg|Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
1034873|NCT00731692|P3|Participant Flow|Placebo to -FTY 0.5 mg|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
1034874|NCT00731692|P2|Participant Flow|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
1034875|NCT00731692|P1|Participant Flow|FTY720 1.25 mg to 0.5 mg|Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
1034878|NCT00731692|O3|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
1034879|NCT00731692|O2|Outcome|FTY720 1.25mg to 0.5 mg|fingolimod 1.25mg/0.5 mg group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg
1034880|NCT00731692|O1|Outcome|FTY720 1.25 mg to 0.5 mg|Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
1034881|NCT00731692|O3|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
1034882|NCT00731692|O2|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
1034883|NCT00731692|O1|Outcome|FTY720 1.25 mg to 0.5 mg|Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
1034884|NCT00731692|O3|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
1034885|NCT00731692|O2|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
1034886|NCT00731692|O1|Outcome|FTY720 1.25 mg to 0.5 mg|Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
1034887|NCT00731692|O3|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
1034888|NCT00731692|O2|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
1034889|NCT00731692|O1|Outcome|FTY720 1.25 mg to 0.5 mg|Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
1034890|NCT00731692|O3|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
1034891|NCT00731692|O2|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
1034892|NCT00731692|O1|Outcome|FTY720 1.25 mg to 0.5 mg|Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
1034893|NCT00731692|O3|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
1034894|NCT00731692|O2|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
1034895|NCT00731692|O1|Outcome|FTY720 1.25 mg to 0.5 mg|Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
1034896|NCT00731692|O2|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
1034897|NCT00731692|O1|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
1034898|NCT00731692|O2|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
1034899|NCT00731692|O1|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
1034900|NCT00731692|O2|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
1034901|NCT00731692|O1|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
1034902|NCT00731692|O2|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
1034903|NCT00731692|O1|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
1034904|NCT00731692|O2|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
1034905|NCT00731692|O1|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
1034906|NCT00731692|O2|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
1034907|NCT00731692|O1|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
1034908|NCT00731692|O2|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
1034909|NCT00731692|O1|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
1034910|NCT00731692|O2|Outcome|Placebo|Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
1034911|NCT00731692|O1|Outcome|FTY720 0.5 mg to 0.5 mg|Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
1034912|NCT00731692|E6|Reported Event|Extension: Placebo-FTY0.5|Patients who received Placebo in core and received 0.5 mg of FTY during Extension
1034913|NCT00731692|E5|Reported Event|Extension: FTY0.5-0.5|Patients who received FTY20 0.5 mg in core and received 0.5 mg of FTY during Extension
1034914|NCT00731692|E4|Reported Event|Extension: FTY1.25-0.5|Patients who received FTY20 1.25 mg in core and received 0.5 mg of FTY during Extension
1034915|NCT00731692|E3|Reported Event|Core: Placebo|Patients who received Placebo during core
1034916|NCT00731692|E2|Reported Event|Core: FTY720 0.5 mg|Patients who received FTY720 0.5 mg during core
1034917|NCT00731692|E1|Reported Event|Core: FTY720 1.25 mg|Patients who received FTY720 1.25 mg during core
1034918|NCT00731679|B3|Baseline|Total|Total of all reporting groups
1034919|NCT00731679|B2|Baseline|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
1035025|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
1034920|NCT00731679|B1|Baseline|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
1034921|NCT00731679|P2|Participant Flow|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
1034922|NCT00731679|P1|Participant Flow|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
1034923|NCT00731679|O2|Outcome|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
1034924|NCT00731679|O1|Outcome|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
1034925|NCT00731679|O2|Outcome|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
1034926|NCT00731679|O1|Outcome|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
1034927|NCT00731679|E2|Reported Event|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
1034928|NCT00731679|E1|Reported Event|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
1034929|NCT00731666|B1|Baseline|Titan® IPP|Subjects implanted with Titan® IPP
1034930|NCT00731666|P1|Participant Flow|Titan® IPP|Subjects implanted with Titan® IPP
1034931|NCT00731666|O1|Outcome|Titan® IPP|Subjects implanted with Titan® IPP
1034932|NCT00731666|O1|Outcome|Titan® IPP|Subjects implanted with Titan® IPP
1034933|NCT00731666|O1|Outcome|Titan® IPP|Subjects implanted with Titan® IPP
1034934|NCT00731666|E1|Reported Event|Titan® IPP|Subjects implanted with Titan® IPP
1034935|NCT00731653|B1|Baseline|BCI-024 and BCI-049 (Buspirone and Melatonin)|BCI-024 (Buspirone)30 mg QD and BCI-049 (Melatonin) 6 mg QD Open-label
1034936|NCT00731653|P1|Participant Flow|BCI-024 and BCI-049 (Buspirone and Melatonin)|BCI-024 (Buspirone)30 mg QD and BCI-049 (Melatonin) 6 mg QD Open-label
1034937|NCT00731653|O1|Outcome|BCI-024 and BCI-049 (Buspirone and Melatonin)|BCI-024 (Buspirone)30 mg QD and BCI-049 (Melatonin) 6 mg QD Open-label
1034938|NCT00731653|E1|Reported Event|BCI-024 and BCI-049 (Buspirone and Melatonin)|BCI-024 (Buspirone)30 mg QD and BCI-049 (Melatonin) 6 mg QD Open-label
1034939|NCT00731640|B3|Baseline|Total|Total of all reporting groups
1034940|NCT00731640|B2|Baseline|Phakic|Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
1034941|NCT00731640|B1|Baseline|Monofocal|Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
1034942|NCT00731640|P2|Participant Flow|Phakic|Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
1034943|NCT00731640|P1|Participant Flow|Monofocal|Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
1034944|NCT00731640|O2|Outcome|Phakic|Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
1034945|NCT00731640|O1|Outcome|Monofocal|Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
1034946|NCT00731640|O2|Outcome|Phakic|Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
1034947|NCT00731640|O1|Outcome|Monofocal|Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
1034948|NCT00731640|O2|Outcome|Phakic|Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
1034949|NCT00731640|O1|Outcome|Monofocal|Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
1034950|NCT00731640|O2|Outcome|Phakic|Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
1034951|NCT00731640|O1|Outcome|Monofocal|Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
1034952|NCT00731640|E2|Reported Event|Phakic|Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
1034953|NCT00731640|E1|Reported Event|Monofocal|Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
1034954|NCT00731614|B3|Baseline|Total|Total of all reporting groups
1034955|NCT00731614|B2|Baseline|Supportive Psychotherapy|Supportive therapy: Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
1034956|NCT00731614|B1|Baseline|Cognitive Behavior Therapy + Mirror Retraining|"Cognitive Behavioral Therapy and Mirror Retraining: Cognitive Behavioral Pain Management treatment administered in 8 weeks of individual treatment, combined with training in use of a mirror device to reduce phantom limb pain.~Mirror retraining: Use of a mirror to produce an illusion of the missing limb. By attending to the reflected limb while moving the existing limb, the patient provides visual feedback that helps correct changes in the neural organization of the somatosensory cortex resulting from the amputation and contributing to the phantom limb pain"
1034957|NCT00731614|P2|Participant Flow|Supportive Psychotherapy|Supportive therapy: Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
1034974|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
1035026|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1034958|NCT00731614|P1|Participant Flow|Cognitive Behavior Therapy + Mirror Retraining|"Cognitive Behavioral Therapy and Mirror Retraining: Cognitive Behavioral Pain Management treatment administered in 8 weeks of individual treatment, combined with training in use of a mirror device to reduce phantom limb pain.~Mirror retraining: Use of a mirror to produce an illusion of the missing limb. By attending to the reflected limb while moving the existing limb, the patient provides visual feedback that helps correct changes in the neural organization of the somatosensory cortex resulting from the amputation and contributing to the phantom limb pain"
1034959|NCT00731614|O2|Outcome|Supportive Psychotherapy|Supportive therapy: Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
1034960|NCT00731614|O1|Outcome|Cognitive Behavior Therapy + Mirror Retraining|"Cognitive Behavioral Therapy and Mirror Retraining: Cognitive Behavioral Pain Management treatment administered in 8 weeks of individual treatment, combined with training in use of a mirror device to reduce phantom limb pain.~Mirror retraining: Use of a mirror to produce an illusion of the missing limb. By attending to the reflected limb while moving the existing limb, the patient provides visual feedback that helps correct changes in the neural organization of the somatosensory cortex resulting from the amputation and contributing to the phantom limb pain"
1034961|NCT00731614|E2|Reported Event|Supportive Psychotherapy|Supportive therapy: Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
1034962|NCT00731614|E1|Reported Event|Cognitive Behavior Therapy + Mirror Retraining|"Cognitive Behavioral Therapy and Mirror Retraining: Cognitive Behavioral Pain Management treatment administered in 8 weeks of individual treatment, combined with training in use of a mirror device to reduce phantom limb pain.~Mirror retraining: Use of a mirror to produce an illusion of the missing limb. By attending to the reflected limb while moving the existing limb, the patient provides visual feedback that helps correct changes in the neural organization of the somatosensory cortex resulting from the amputation and contributing to the phantom limb pain"
1034963|NCT00731549|B1|Baseline|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
1034964|NCT00731549|P1|Participant Flow|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
1034965|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
1034966|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
1034967|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
1034968|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
1034969|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
1034970|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
1034971|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
1034972|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
1034973|NCT00731549|O1|Outcome|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
1035023|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1035024|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
1034975|NCT00731549|E1|Reported Event|Aripiprazole 400/300 mg IM Depot|Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
1034976|NCT00731484|B1|Baseline|General Population|Healthy normal volunteers as well as subjects diagnosed with moderate or severe chronic dry eye disease and/or Sjögrens syndrome. Subjects were recruited from among patients presenting for a routine visit at the physician office study sites.
1034977|NCT00731484|P1|Participant Flow|General Population|Healthy normal volunteers as well as subjects diagnosed with moderate or severe chronic dry eye disease and/or Sjögrens syndrome. Subjects were recruited from among patients presenting for a routine visit at the physician office study sites.
1034978|NCT00731484|O1|Outcome|General Population|Subjects were recruited from patients presenting for a routine visit at the physician office study sites
1034979|NCT00731484|E1|Reported Event|General Population|Healthy normal volunteers as well as subjects diagnosed with moderate or severe chronic dry eye disease and/or Sjögrens syndrome. Subjects were recruited from among patients presenting for a routine visit at the physician office study sites.
1034980|NCT00731341|B1|Baseline|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
1034981|NCT00731341|P1|Participant Flow|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
1034982|NCT00731341|O1|Outcome|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
1034983|NCT00731341|O1|Outcome|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
1034984|NCT00731341|O1|Outcome|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
1034985|NCT00731341|O1|Outcome|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
1034986|NCT00731341|O1|Outcome|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
1034987|NCT00731341|O1|Outcome|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
1034988|NCT00731341|E1|Reported Event|Cryoablation for the Treatment of Uterine Fibroids|All patients in this feasibility study had ultrasound-guided cryoablation of uterine fibroids
1034989|NCT00731211|B1|Baseline|Pazopanib|"800 mg of pazopanib orally each day continuously~Pazopanib: 800 mg of pazopanib orally each day continuously"
1034990|NCT00731211|P1|Participant Flow|Pazopanib|"800 mg of pazopanib orally each day continuously~Pazopanib: 800 mg of pazopanib orally each day continuously"
1034991|NCT00731211|O1|Outcome|Pazopanib|"800 mg of pazopanib orally each day continuously~Pazopanib: 800 mg of pazopanib orally each day continuously"
1034992|NCT00731211|O1|Outcome|Pazopanib|"800 mg of pazopanib orally each day continuously~Pazopanib: 800 mg of pazopanib orally each day continuously"
1034993|NCT00731211|E1|Reported Event|Pazopanib|"800 mg of pazopanib orally each day continuously~Pazopanib: 800 mg of pazopanib orally each day continuously"
1034994|NCT00731198|B3|Baseline|Total|Total of all reporting groups
1034995|NCT00731198|B2|Baseline|Active Comparator|Hyoscine-N-butylbromide
1034996|NCT00731198|B1|Baseline|Experimental|Drotaverine hydrochloride
1034997|NCT00731198|P2|Participant Flow|Active Comparator|Hyoscine-N-butylbromide
1034998|NCT00731198|P1|Participant Flow|Experimental|Drotaverine hydrochloride
1034999|NCT00731198|O2|Outcome|Active Comparator|Hyoscine-N-butylbromide
1035000|NCT00731198|O1|Outcome|Experimental|Drotaverine hydrochloride
1035001|NCT00731198|E2|Reported Event|Active Comparator|Hyoscine-N-butylbromide
1035002|NCT00731198|E1|Reported Event|Experimental|Drotaverine hydrochloride
1035003|NCT00731133|B1|Baseline|Disulfiram|Disulfiram at 250 mg daily
1035004|NCT00731133|P1|Participant Flow|Disulfiram|Disulfiram at 250 mg daily
1035005|NCT00731133|O1|Outcome|Disulfiram 250 mg|
1035006|NCT00731133|O1|Outcome|Disulfiram 250 mg|
1035007|NCT00731133|E1|Reported Event|Disulfiram|Disulfiram at 250 mg daily
1035008|NCT00731120|B4|Baseline|Total|Total of all reporting groups
1035009|NCT00731120|B3|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
1035010|NCT00731120|B2|Baseline|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
1035011|NCT00731120|B1|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1035012|NCT00731120|P3|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
1035013|NCT00731120|P2|Participant Flow|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
1035014|NCT00731120|P1|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1035015|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
1035016|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
1035017|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1035018|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
1035019|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
1035020|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1035021|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
1035022|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
1035028|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
1035029|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1035030|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
1035031|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
1035032|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1035033|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
1035034|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
1035035|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1035036|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
1035037|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
1035038|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1035039|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
1035040|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
1035041|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1035042|NCT00731120|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
1035043|NCT00731120|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
1035044|NCT00731120|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1035045|NCT00731120|E3|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
1035046|NCT00731120|E2|Reported Event|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks
1035047|NCT00731120|E1|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
1035048|NCT00731094|B3|Baseline|Total|Total of all reporting groups
1035049|NCT00731094|B2|Baseline|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035050|NCT00731094|B1|Baseline|Physcial Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035051|NCT00731094|P2|Participant Flow|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035052|NCT00731094|P1|Participant Flow|Physcial Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035053|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035054|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035055|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035056|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035057|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035058|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035059|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1037659|NCT00724594|P1|Participant Flow|NAC Infant|Infants treated with N-acetylcysteine
1035154|NCT00730912|P2|Participant Flow|Pediatrics 7 to 15 Years|Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days
1038976|NCT00721175|O1|Outcome|SEMS|SEMS (Self-expandable metal stent group)
1035060|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035061|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035062|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035063|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035064|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035065|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035066|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035067|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035068|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035069|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035070|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035071|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035072|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035073|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035074|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035075|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035076|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035077|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035146|NCT00730925|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
1035152|NCT00730912|B1|Baseline|Pediatrics 3 to 6 Years|Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days
1040070|NCT00718081|O1|Outcome|Sufentanil NanoTab 10 mcg|
1035078|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035079|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035080|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035081|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035082|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035083|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035084|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035085|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035086|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035087|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035088|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035089|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035090|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035091|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035092|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035093|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035094|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035095|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035147|NCT00730925|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
1035153|NCT00730912|P3|Participant Flow|Adults 16 to 64 Years|Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days
1035096|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035097|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035098|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035099|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035100|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035101|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035102|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035103|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035104|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035105|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035106|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035107|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035108|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035109|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035110|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035111|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035112|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035113|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035148|NCT00730925|E1|Reported Event|Afatinib 50mg|Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
1035149|NCT00730912|B4|Baseline|Total|Total of all reporting groups
1035150|NCT00730912|B3|Baseline|Adults 16 to 64 Years|Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days
1035114|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035115|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035116|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035117|NCT00731094|O2|Outcome|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035118|NCT00731094|O1|Outcome|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035119|NCT00731094|E2|Reported Event|Attention Control|Generalized baseline healthy lifestyle education and suggestion to increase physical activity, with a 12-month follow-up via postal mail of 14 wellness newsletters focused on health issues other than physical activity
1035120|NCT00731094|E1|Reported Event|Physical Activity Intervention|Individualized baseline counseling and guided goal setting to increase physical activity gradually to at least 150 minutes/week of moderate intensity, with a 12-month follow-up via postal mail of 14 additional counseling contacts generated by responses to a physical activity questionnaire and individually tailored computer-generated expert system feedback messages for physical activity based on stages of the motivational readiness for change model
1035121|NCT00731055|B1|Baseline|Study Participants|Each of study participants received one dose of study medication (varenicline 0mg, 0.5mg, 1mg, and 2 mg) before each of the experimental sessions at least 5 days apart.
1035122|NCT00731055|P1|Participant Flow|Study Participants|This is a within-group study design, all participant who completed the study receive all 4 experimental treatments
1035123|NCT00731055|O4|Outcome|Varenicline 2.0 mg|The outcome of the session during which participant received varenicline 2.0 mg
1035124|NCT00731055|O3|Outcome|Varenicline 1.0 mg|The outcome of the session during which participant received varenicline 1.0 mg
1035125|NCT00731055|O2|Outcome|Varenicline 0.5 mg|The outcome of the session during which participant received varenicline 0.5 mg
1035126|NCT00731055|O1|Outcome|Placebo|The outcome of the session during which participant received placebo
1035127|NCT00731055|E1|Reported Event|Study Participants|Each of study participants received one dose of study medication (varenicline 0mg, 0.5mg, 1mg, and 2 mg) before each of the experimental sessions at least 5 days apart.
1035128|NCT00731042|B3|Baseline|Total|Total of all reporting groups
1035129|NCT00731042|B2|Baseline|Avagard First Followed by Purell|Using Avagard for 14 days. Rest for 5 days(no product used). Then use Purell for 14 days.
1035130|NCT00731042|B1|Baseline|Purell First Followed by Avagard|Using Purell for 14 days. Rest for 5 days(no product used). Then use Avagard for 14 days.
1035131|NCT00731042|P2|Participant Flow|Avagard First Followed by Purell|Using Avagard for 14 days. Rest for 5 days(no product used). Then use Purell for 14 days.
1035132|NCT00731042|P1|Participant Flow|Purell First Followed by Avagard|Using Purell for 14 days. Rest for 5 days(no product used). Then use Avagard for 14 days.
1035133|NCT00731042|O2|Outcome|Avagard First Followed by Purell|Using Avagard for 14 days. Rest for 5 days(no product used). Then use Purell for 14 days.
1035134|NCT00731042|O1|Outcome|Purell First Followed by Avagard|Using Purell for 14 days. Rest for 5 days(no product used). Then use Avagard for 14 days.
1035135|NCT00731042|E2|Reported Event|Avagard First Followed by Purell|Using Avagard for 14 days. Rest for 5 days(no product used). Then use Purell for 14 days.
1035136|NCT00731042|E1|Reported Event|Purell First Followed by Avagard|Using Purell for 14 days. Rest for 5 days(no product used). Then use Avagard for 14 days.
1035137|NCT00730964|B1|Baseline|Arm 1 - Optison|Open Label with 1039 subjects that received Optison to evaluate the safety of the product
1035138|NCT00730964|P1|Participant Flow|Arm 1 - Optison|Open Label with 1039 subjects that received Optison to evaluate the safety of the product
1035139|NCT00730964|O1|Outcome|Arm 1 - Optison|Open Label with 1039 subjects that received Optison to evaluate the safety of the product
1035140|NCT00730964|O1|Outcome|Arm 1 - Optison|Open Label with 1039 subjects that received Optison to evaluate the safety of the product.
1035141|NCT00730964|E1|Reported Event|Arm 1 - Optison|Open Label with 1039 subjects that received Optison to evaluate the safety of the product
1035142|NCT00730925|B1|Baseline|Afatinib 50mg|Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
1035143|NCT00730925|P1|Participant Flow|Afatinib 50mg|Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
1035144|NCT00730925|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
1035145|NCT00730925|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
1035151|NCT00730912|B2|Baseline|Pediatrics 7 to 15 Years|Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days
1035155|NCT00730912|P1|Participant Flow|Pediatrics 3 to 6 Years|Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days
1035156|NCT00730912|O3|Outcome|Adults 16 to 64 Years|Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days
1035157|NCT00730912|O2|Outcome|Pediatrics 7 to 15 Years|Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days
1035158|NCT00730912|O1|Outcome|Pediatrics 3 to 6 Years|Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days
1035159|NCT00730912|O3|Outcome|Adults 16 to 64 Years|Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days
1035160|NCT00730912|O2|Outcome|Pediatrics 7 to 15 Years|Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days
1035161|NCT00730912|O1|Outcome|Pediatrics 3 to 6 Years|Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days
1035162|NCT00730912|E3|Reported Event|Adults 16 to 64 Years|Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days
1035163|NCT00730912|E2|Reported Event|Pediatrics 7 to 15 Years|Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days
1035164|NCT00730912|E1|Reported Event|Pediatrics 3 to 6 Years|Pediatrics 3 to 6 years of age received loratadine 5 mg/day for 28 days
1035165|NCT00730847|B1|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
1035166|NCT00730847|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
1035167|NCT00730847|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
1035168|NCT00730847|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
1035169|NCT00730847|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
1035170|NCT00730847|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
1035171|NCT00730847|E1|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
1035172|NCT00730756|B3|Baseline|Total|Total of all reporting groups
1035173|NCT00730756|B2|Baseline|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
1035174|NCT00730756|B1|Baseline|Placebo|Vehicle placebo nasal spray once daily
1035175|NCT00730756|P2|Participant Flow|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
1035176|NCT00730756|P1|Participant Flow|Placebo|Vehicle placebo nasal spray once daily
1035177|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
1035178|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
1035179|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
1035180|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
1035181|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
1035182|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
1035183|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
1035184|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
1035185|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
1035186|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
1035187|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
1035188|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
1035189|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
1035190|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
1035191|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
1035192|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
1035193|NCT00730756|O2|Outcome|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
1035194|NCT00730756|O1|Outcome|Placebo|Vehicle placebo nasal spray once daily
1035195|NCT00730756|E2|Reported Event|FFNS 110 mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
1035196|NCT00730756|E1|Reported Event|Placebo|Vehicle placebo nasal spray once daily
1035197|NCT00730730|B1|Baseline|Iliac Stenting|Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
1035198|NCT00730730|P1|Participant Flow|Complete SE Iliac Stent|Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
1035199|NCT00730730|O1|Outcome|Complete SE Iliac Stent|Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
1035200|NCT00730730|O1|Outcome|Complete SE Iliac Stent|Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
1035201|NCT00730730|O1|Outcome|Complete SE Iliac Stent|Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
1035202|NCT00730730|O1|Outcome|Complete SE Iliac Stent|Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
1035431|NCT00730275|O3|Outcome|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
1035242|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
1035203|NCT00730730|E1|Reported Event|Iliac Stenting|Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
1035204|NCT00730691|B6|Baseline|Total|Total of all reporting groups
1035205|NCT00730691|B5|Baseline|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
1035206|NCT00730691|B4|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035207|NCT00730691|B3|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
1035208|NCT00730691|B2|Baseline|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035209|NCT00730691|B1|Baseline|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1035210|NCT00730691|P5|Participant Flow|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
1035211|NCT00730691|P4|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035212|NCT00730691|P3|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
1035213|NCT00730691|P2|Participant Flow|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035214|NCT00730691|P1|Participant Flow|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1035215|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
1035216|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035217|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
1035218|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035219|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1035220|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
1035221|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035222|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
1035223|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035224|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1035225|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
1035226|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035227|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
1035228|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035229|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1035230|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
1035231|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035232|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
1035233|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035234|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1035235|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
1035236|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035237|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
1035238|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035239|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1035240|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
1035241|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1037660|NCT00724594|O4|Outcome|Control Maternal|Mothers treated with saline prior to delivery
1035243|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035244|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1035245|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
1035246|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035247|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
1035248|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035249|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1035250|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
1035251|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035252|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
1035253|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035254|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1035255|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
1035256|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035257|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
1035258|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035259|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1035260|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
1035261|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035262|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
1035263|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035264|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1035265|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
1035266|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035267|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
1035268|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035269|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1035270|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
1035271|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035272|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
1035273|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035274|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1035275|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
1035276|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035277|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
1035278|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035279|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1035280|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
1035432|NCT00730275|O2|Outcome|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
1035281|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035282|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
1035283|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035284|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1035285|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
1035286|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035287|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
1035288|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035289|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1035290|NCT00730691|O5|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
1035291|NCT00730691|O4|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035292|NCT00730691|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
1035293|NCT00730691|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035294|NCT00730691|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1035295|NCT00730691|E5|Reported Event|Duloxetine 60 mg|Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
1035296|NCT00730691|E4|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035297|NCT00730691|E3|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsule, orally, once daily, for 1 week.
1035298|NCT00730691|E2|Reported Event|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week.
1035299|NCT00730691|E1|Reported Event|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1035300|NCT00730639|B6|Baseline|Total|Total of all reporting groups
1035301|NCT00730639|B5|Baseline|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
1035302|NCT00730639|B4|Baseline|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
1035303|NCT00730639|B3|Baseline|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
1035304|NCT00730639|B2|Baseline|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
1035305|NCT00730639|B1|Baseline|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
1035306|NCT00730639|P5|Participant Flow|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered by IV every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks. Re-initiation of study therapy was permitted for participants who entered the follow-up period with ongoing CR, PR, or SD, who subsequently experienced confirmed PD.
1035307|NCT00730639|P4|Participant Flow|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered by IV every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks. Re-initiation of study therapy was permitted for participants who entered the follow-up period with ongoing CR, PR, or SD, who subsequently experienced confirmed PD.
1035308|NCT00730639|P3|Participant Flow|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered by IV every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks. Re-initiation of study therapy was permitted for participants who entered the follow-up period with ongoing CR, PR, or SD, who subsequently experienced confirmed PD.
1035309|NCT00730639|P2|Participant Flow|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered by IV every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks. Re-initiation of study therapy was permitted for participants who entered the follow-up period with ongoing CR, PR, or SD, who subsequently experienced confirmed PD.
1035344|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
1035433|NCT00730275|O1|Outcome|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
1040071|NCT00718081|E3|Reported Event|Placebo NanoTab|
1035434|NCT00730275|E4|Reported Event|Placebo|Participants who received a single oral dose of matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.
1035310|NCT00730639|P1|Participant Flow|0.1 mg/kg Nivolumab|0.1 milligrams (mg) of nivolumab per kilogram (kg) of body weight (mg/kg)was administered intravenously (IV) every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed complete response (CR), worsening progressive disease (PD), or unacceptable toxicity, up to 12 cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks. Re-initiation of study therapy was permitted for participants who entered the follow-up period with ongoing CR, partial response (PR), or stable disease (SD), who subsequently experienced confirmed PD.
1035311|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
1035312|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
1035313|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
1035314|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
1035315|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
1035316|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
1035317|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
1035318|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
1035319|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
1035320|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
1035321|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
1035322|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
1035323|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
1035324|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
1035325|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
1035326|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
1035327|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
1035328|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
1035329|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
1035330|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
1035331|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
1035332|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
1035333|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
1035334|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
1035335|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
1035336|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
1035337|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
1035338|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
1035339|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
1035340|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each cycle.
1035341|NCT00730639|O6|Outcome|All Dose Groups|All participants receiving Intravenous (IV) solution of 0.1-10 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed complete response (CR), worsening progressive disease (PD), or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
1035342|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
1035343|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
1035490|NCT00730028|B6|Baseline|Total|Total of all reporting groups
1035345|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
1035346|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed complete response (CR), worsening progressive disease (PD), or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
1035347|NCT00730639|O6|Outcome|All Dose Groups|All participants receiving Intravenous (IV) solution of 0.1-10 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed complete response (CR), worsening progressive disease (PD), or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
1035348|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
1035349|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
1035350|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
1035351|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed CR, worsening PD, or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
1035352|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 (Cycle 1). Response was assessed between Days 52 and 56, before the first dose of the next cycle. Participants were treated until confirmed complete response (CR), worsening progressive disease (PD), or unacceptable toxicity, up to 12 Cycles of treatment (96 weeks; 48 doses). Follow-up was up to 48 weeks.
1035353|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
1035354|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
1035355|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
1035356|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
1035357|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
1035358|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
1035359|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
1035360|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
1035361|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
1035362|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
1035363|NCT00730639|O5|Outcome|10 mg/kg Nivolumab|10 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
1035364|NCT00730639|O4|Outcome|3.0 mg/kg Nivolumab|3.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
1035365|NCT00730639|O3|Outcome|1.0 mg/kg Nivolumab|1.0 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
1035366|NCT00730639|O2|Outcome|0.3 mg/kg Nivolumab|0.3 mg/kg nivolumab was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
1035367|NCT00730639|O1|Outcome|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
1035368|NCT00730639|E5|Reported Event|10 mg/kg Nivolumab|IV solution of 10 milligrams nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
1035369|NCT00730639|E4|Reported Event|3 mg/kg Nivolumab|IV solution of 3 milligrams nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
1035370|NCT00730639|E3|Reported Event|1 mg/kg Nivolumab|IV solution of 1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
1035371|NCT00730639|E2|Reported Event|0.3 mg/kg Nivolumab|IV solution of 0.3 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
1035372|NCT00730639|E1|Reported Event|0.1 mg/kg Nivolumab|Intravenous (IV) solution of 0.1 milligram nivolumab per kilogram of body weight (mg/kg) was administered every 2 weeks; Dosing on Days 1, 15, 29, and 43 of each treatment cycle.
1035373|NCT00730353|B1|Baseline|Paclitaxel and Sutinib Malate|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.~Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.~Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion."
1035374|NCT00730353|P1|Participant Flow|Paclitaxel and Sutinib Malate|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.~Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.~Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion."
1035375|NCT00730353|O1|Outcome|Paclitaxel and Sutinib Malate|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.~Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.~Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion."
1035376|NCT00730353|O1|Outcome|Paclitaxel and Sutinib Malate|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.~Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.~Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion."
1035377|NCT00730353|O1|Outcome|Paclitaxel and Sutinib Malate|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.~Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.~Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion."
1035378|NCT00730353|O1|Outcome|Paclitaxel and Sutinib Malate|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.~Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.~Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion."
1035379|NCT00730353|O1|Outcome|Paclitaxel and Sutinib Malate|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.~Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.~Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion."
1035380|NCT00730353|E1|Reported Event|Paclitaxel and Sutinib Malate|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.~Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.~Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion."
1035381|NCT00730327|B3|Baseline|Total|Total of all reporting groups
1035382|NCT00730327|B2|Baseline|Control|"Control arm receives the Behavioral modification intervention only.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
1035383|NCT00730327|B1|Baseline|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
1035384|NCT00730327|P2|Participant Flow|Control|"Control arm receives the Behavioral modification intervention only.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
1035385|NCT00730327|P1|Participant Flow|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
1035386|NCT00730327|O2|Outcome|Control|"Control arm receives the Behavioral modification intervention only.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
1035387|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
1035388|NCT00730327|O2|Outcome|Control|"Control arm receives the Behavioral modification intervention only.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
1035389|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
1035390|NCT00730327|O2|Outcome|Control|"Control arm receives the Behavioral modification intervention only.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
1035429|NCT00730275|O1|Outcome|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
1035430|NCT00730275|O4|Outcome|Placebo|Participants who received a single oral dose of a matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.
1035391|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
1035392|NCT00730327|O2|Outcome|Control|"Control arm receives the Behavioral modification intervention only.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
1035393|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
1035394|NCT00730327|O2|Outcome|Control|"Control arm receives the Behavioral modification intervention only.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
1035395|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
1035396|NCT00730327|O2|Outcome|Control|"Control arm receives the Behavioral modification intervention only.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
1035397|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
1035398|NCT00730327|O2|Outcome|Control|"Control arm receives the Behavioral modification intervention only.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
1035399|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
1035400|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
1035401|NCT00730327|O2|Outcome|Control|"Control arm receives the Behavioral modification intervention only.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
1035402|NCT00730327|O1|Outcome|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
1035403|NCT00730327|E2|Reported Event|Control|Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
1035404|NCT00730327|E1|Reported Event|BIB®|"Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.~BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach.~Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise"
1035405|NCT00730275|B5|Baseline|Total|Total of all reporting groups
1035406|NCT00730275|B4|Baseline|Placebo|Participants who received a single oral dose of a matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.
1035407|NCT00730275|B3|Baseline|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
1035408|NCT00730275|B2|Baseline|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
1035409|NCT00730275|B1|Baseline|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
1035410|NCT00730275|P4|Participant Flow|Placebo|Participants who received a single oral dose of a matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.
1035411|NCT00730275|P3|Participant Flow|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
1035412|NCT00730275|P2|Participant Flow|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
1035413|NCT00730275|P1|Participant Flow|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
1035414|NCT00730275|O4|Outcome|Placebo|Participants who received a single oral dose of matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.
1035415|NCT00730275|O3|Outcome|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
1035416|NCT00730275|O2|Outcome|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
1035417|NCT00730275|O1|Outcome|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
1035418|NCT00730275|O3|Outcome|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
1035419|NCT00730275|O2|Outcome|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
1035420|NCT00730275|O1|Outcome|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
1035421|NCT00730275|O3|Outcome|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
1035422|NCT00730275|O2|Outcome|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
1035423|NCT00730275|O1|Outcome|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
1035424|NCT00730275|O3|Outcome|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
1035425|NCT00730275|O2|Outcome|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
1035426|NCT00730275|O1|Outcome|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
1035427|NCT00730275|O3|Outcome|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
1035428|NCT00730275|O2|Outcome|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
1035435|NCT00730275|E3|Reported Event|Sitagliptin 200 mg|Participants who received a single oral dose of sitagliptin 200 mg.
1035436|NCT00730275|E2|Reported Event|Sitagliptin 100 mg|Participants who received a single oral dose of sitagliptin 100 mg.
1035437|NCT00730275|E1|Reported Event|Sitagliptin 50 mg|Participants who received a single oral dose of sitagliptin 50 mg.
1035438|NCT00730236|B1|Baseline|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
1035439|NCT00730236|P1|Participant Flow|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
1035440|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
1035441|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
1035442|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
1035443|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
1035444|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
1035445|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
1035446|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
1035447|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
1035448|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
1035449|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
1035450|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
1035451|NCT00730236|O1|Outcome|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
1035452|NCT00730236|E1|Reported Event|Lomitapide Escalated|Lomitapide escalated with an initial oral dose of 5 mg/day for 2 weeks and then escalated at 4 week intervals to 60 mg/day. In rare situations (1 patient)who met strict safety and efficacy criteria could have their dose escalated to 80 mg/day.
1035453|NCT00730132|B1|Baseline|Enrolled Patients|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy and who consented to enroll in this observational study, allowing collection of data regarding change in treatment, and treatment efficacy and safety.
1035454|NCT00730132|P1|Participant Flow|Enrolled Patients|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy and who consented to enroll in this observational study, allowing collection of data regarding change in treatment, and treatment efficacy and safety.
1035455|NCT00730132|O3|Outcome|New Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by transition to a new statin therapy
1035456|NCT00730132|O2|Outcome|Statin Dose Titration|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by increasing the dose of ongoing statin therapy
1035457|NCT00730132|O1|Outcome|Ezetimibe Added to Existing Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by the addition of ezetimibe to ongoing statin
1035458|NCT00730132|O3|Outcome|New Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by transition to a new statin therapy
1035547|NCT00730015|B3|Baseline|Placebo|Dose matched placebo, oral administration, once per day
1040072|NCT00718081|E2|Reported Event|Sufentanil NanoTab 15 mcg|
1035548|NCT00730015|B2|Baseline|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
1035459|NCT00730132|O2|Outcome|Statin Dose Titration|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by increasing the dose of ongoing statin therapy
1035460|NCT00730132|O1|Outcome|Ezetimibe Added to Existing Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by the addition of ezetimibe to ongoing statin
1035461|NCT00730132|O3|Outcome|New Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by transition to a new statin therapy
1035462|NCT00730132|O2|Outcome|Statin Dose Titration|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by increasing the dose of ongoing statin therapy
1035463|NCT00730132|O1|Outcome|Ezetimibe Added to Existing Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by the addition of ezetimibe to ongoing statin
1035464|NCT00730132|O3|Outcome|New Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by transition to a new statin therapy
1035465|NCT00730132|O2|Outcome|Statin Dose Titration|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by increasing the dose of ongoing statin therapy
1035466|NCT00730132|O1|Outcome|Ezetimibe Added to Existing Statin|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) and whose lipid-lowering therapy was modified by the addition of ezetimibe to ongoing statin
1035467|NCT00730132|O1|Outcome|All Participants Analyzed|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C. A participant was included in the study in case the lipid lowering therapy was modified in one of the following options: 1- statin dose (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) titration, 2- administration of a new statin (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin), 3- administration of ezetimibe in addition to current statin (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin) therapy.
1035468|NCT00730132|E1|Reported Event|Enrolled Patients|Patients with established diagnosis of CHD and hypercholesterolemia who did not achieve the target values for TC and LDL-C with existing statin therapy and who consented to enroll in this observational study, allowing collection of data regarding change in treatment, and treatment efficacy and safety.
1035469|NCT00730041|B3|Baseline|Total|Total of all reporting groups
1035470|NCT00730041|B2|Baseline|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
1035471|NCT00730041|B1|Baseline|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
1035472|NCT00730041|P2|Participant Flow|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
1035473|NCT00730041|P1|Participant Flow|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
1035474|NCT00730041|O2|Outcome|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
1035475|NCT00730041|O1|Outcome|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
1035476|NCT00730041|O2|Outcome|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
1035477|NCT00730041|O1|Outcome|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
1035478|NCT00730041|O2|Outcome|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
1035479|NCT00730041|O1|Outcome|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
1035480|NCT00730041|O2|Outcome|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
1035481|NCT00730041|O1|Outcome|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
1035482|NCT00730041|O2|Outcome|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
1035483|NCT00730041|O1|Outcome|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
1035484|NCT00730041|O2|Outcome|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
1035485|NCT00730041|O1|Outcome|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
1035486|NCT00730041|O2|Outcome|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
1035487|NCT00730041|O1|Outcome|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
1035488|NCT00730041|E2|Reported Event|Sham Procedure With no Implants|Sham (procedure but no implants inserted) in combination with continuous positive airway pressure (CPAP)
1035489|NCT00730041|E1|Reported Event|Pillar(R) Palatal Implants|Pillar Implants in combination with continuous positive airway pressure (CPAP)
1035491|NCT00730028|B5|Baseline|Limited Abscess – Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
1035492|NCT00730028|B4|Baseline|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
1035493|NCT00730028|B3|Baseline|Limited Abscess – Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
1035494|NCT00730028|B2|Baseline|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
1035495|NCT00730028|B1|Baseline|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
1035496|NCT00730028|P5|Participant Flow|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
1035497|NCT00730028|P4|Participant Flow|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
1035498|NCT00730028|P3|Participant Flow|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
1035499|NCT00730028|P2|Participant Flow|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
1035500|NCT00730028|P1|Participant Flow|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
1035501|NCT00730028|O5|Outcome|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
1035502|NCT00730028|O4|Outcome|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
1035503|NCT00730028|O3|Outcome|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
1035504|NCT00730028|O2|Outcome|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
1035505|NCT00730028|O1|Outcome|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
1035506|NCT00730028|O5|Outcome|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
1035507|NCT00730028|O4|Outcome|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
1035508|NCT00730028|O3|Outcome|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
1035509|NCT00730028|O2|Outcome|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
1035510|NCT00730028|O1|Outcome|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
1035511|NCT00730028|O5|Outcome|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
1035512|NCT00730028|O4|Outcome|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
1035513|NCT00730028|O3|Outcome|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
1035514|NCT00730028|O2|Outcome|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
1035515|NCT00730028|O1|Outcome|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
1035516|NCT00730028|O5|Outcome|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
1035517|NCT00730028|O4|Outcome|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
1035518|NCT00730028|O3|Outcome|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
1035519|NCT00730028|O2|Outcome|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
1035520|NCT00730028|O1|Outcome|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
1035521|NCT00730028|O5|Outcome|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
1035522|NCT00730028|O4|Outcome|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
1035523|NCT00730028|O3|Outcome|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
1035524|NCT00730028|O2|Outcome|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
1035525|NCT00730028|O1|Outcome|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
1035526|NCT00730028|O5|Outcome|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
1035527|NCT00730028|O4|Outcome|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
1035528|NCT00730028|O3|Outcome|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
1035529|NCT00730028|O2|Outcome|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
1035530|NCT00730028|O1|Outcome|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
1035531|NCT00730028|O5|Outcome|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
1035532|NCT00730028|O4|Outcome|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
1035533|NCT00730028|O3|Outcome|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
1035534|NCT00730028|O2|Outcome|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
1035535|NCT00730028|O1|Outcome|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
1035536|NCT00730028|O5|Outcome|Limited Abscess - Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
1035537|NCT00730028|O4|Outcome|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
1035538|NCT00730028|O3|Outcome|Limited Abscess - Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
1035539|NCT00730028|O2|Outcome|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
1035540|NCT00730028|O1|Outcome|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
1035541|NCT00730028|E5|Reported Event|Limited Abscess – Placebo|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter were treated with placebo three times daily.
1035542|NCT00730028|E4|Reported Event|Limited Abscess - TMP-SMX|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
1035543|NCT00730028|E3|Reported Event|Limited Abscess – Clindamycin|Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
1035544|NCT00730028|E2|Reported Event|Cellulitis or Larger Abscess - TMP-SMX|Participants with cellulitis only or abscess > 5 cm in diameter, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
1035545|NCT00730028|E1|Reported Event|Cellulitis or Larger Abscess - Clindamycin|Participants with cellulitis only or abscess > 5 cm in diameter, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
1035546|NCT00730015|B4|Baseline|Total|Total of all reporting groups
1040073|NCT00718081|E1|Reported Event|Sufentanil NanoTab 10 mcg|
1035549|NCT00730015|B1|Baseline|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
1035550|NCT00730015|P3|Participant Flow|Placebo|Dose matched placebo, oral administration, once per day
1035551|NCT00730015|P2|Participant Flow|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
1035552|NCT00730015|P1|Participant Flow|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
1035553|NCT00730015|O3|Outcome|Placebo|Dose matched placebo, oral administration, once per day
1035554|NCT00730015|O2|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
1035555|NCT00730015|O1|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
1035556|NCT00730015|O3|Outcome|Placebo|Dose matched placebo, oral administration, once per day
1035557|NCT00730015|O2|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
1035558|NCT00730015|O1|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
1035559|NCT00730015|O3|Outcome|Placebo|Dose matched placebo, oral administration, once per day
1035560|NCT00730015|O2|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
1035561|NCT00730015|O1|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
1035562|NCT00730015|O3|Outcome|Placebo|Dose matched placebo, oral administration, once per day
1035563|NCT00730015|O2|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
1035564|NCT00730015|O1|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
1035565|NCT00730015|O3|Outcome|Placebo|Dose matched placebo, oral administration, once per day
1035566|NCT00730015|O2|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
1035567|NCT00730015|O1|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
1035568|NCT00730015|O3|Outcome|Placebo|Dose matched placebo, oral administration, once per day
1035569|NCT00730015|O2|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
1035570|NCT00730015|O1|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
1035571|NCT00730015|O3|Outcome|Placebo|Dose matched placebo, oral administration, once per day
1035572|NCT00730015|O2|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
1035573|NCT00730015|O1|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
1035574|NCT00730015|O3|Outcome|Placebo|Dose matched placebo, oral administration, once per day
1035575|NCT00730015|O2|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
1035576|NCT00730015|O1|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
1035577|NCT00730015|E8|Reported Event|Linaclotide 290μg to Linaclotide 290μg RW Period|Linaclotide 290μg, oral administration, once per day to Linaclotide 290μg, oral administration, once per day
1035578|NCT00730015|E7|Reported Event|Linaclotide 290μg to Placebo RW Period|Linaclotide 290μg, oral administration, once per day to Dose-matched placebo, oral administration, once per day
1035579|NCT00730015|E6|Reported Event|Linaclotide 145μg to Linaclotide 145μg RW Period|Linaclotide 145μg, oral administration, once per day to Linaclotide 145μg, oral administration, once per day
1035580|NCT00730015|E5|Reported Event|Linaclotide 145μg to Placebo RW Period|Linaclotide 145μg, oral administration, once per day to Dose-matched placebo, oral administration, once per day
1035581|NCT00730015|E4|Reported Event|Placebo to Linaclotide 290μg Randomized Withdrawal (RW) Period|Dose-matched placebo, oral administration, once per day or Linaclotide 290μg, oral administration, once per day.
1035582|NCT00730015|E3|Reported Event|Placebo|Dose matched placebo, oral administration, once per day
1035583|NCT00730015|E2|Reported Event|Linaclotide 290μg|Linaclotide, 290μg dose, oral administration, once per day
1035584|NCT00730015|E1|Reported Event|Linaclotide 145μg|Linaclotide, 145μg dose, oral administration, once per day
1035585|NCT00729937|B7|Baseline|Total|Total of all reporting groups
1035586|NCT00729937|B6|Baseline|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1035587|NCT00729937|B5|Baseline|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035588|NCT00729937|B4|Baseline|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035589|NCT00729937|B3|Baseline|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1035590|NCT00729937|B2|Baseline|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035591|NCT00729937|B1|Baseline|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1035592|NCT00729937|P6|Participant Flow|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1035593|NCT00729937|P5|Participant Flow|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035594|NCT00729937|P4|Participant Flow|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035658|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1037671|NCT00724594|O3|Outcome|NAC Term Infants|Term infants treated with N-acetylcysteine
1035595|NCT00729937|P3|Participant Flow|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1035596|NCT00729937|P2|Participant Flow|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035597|NCT00729937|P1|Participant Flow|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1035598|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1035599|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035600|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035601|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1035602|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035603|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1035604|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1035605|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035606|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035607|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1035608|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035609|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1035610|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1035611|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035612|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035613|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1035614|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035615|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1035616|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1035617|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035618|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035619|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1035620|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035621|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1035622|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1035623|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035624|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035625|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1036429|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1035626|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035627|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1035628|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1035629|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035630|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035631|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1035632|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035633|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1035634|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1035635|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035636|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035637|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1035638|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035639|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1035640|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1035641|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035642|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035643|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1035644|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035645|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1035646|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1035647|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035648|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035649|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1035650|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035651|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1035652|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1035653|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035654|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035655|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1035656|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035657|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1040074|NCT00718042|B7|Baseline|Total|Total of all reporting groups
1035659|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035660|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035661|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1035662|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035663|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1035664|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1035665|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035666|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035667|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1035668|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035669|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1035670|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1035671|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035672|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035673|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1035674|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035675|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1035676|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1035677|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035678|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035679|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1035680|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035681|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1035682|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1035683|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035684|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035685|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1035686|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035687|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1035688|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1035689|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1036069|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
1035690|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035691|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1035692|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035693|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1035694|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1035695|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035696|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035697|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1035698|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035699|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1035700|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1035701|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035702|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035703|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1035704|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035705|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1035706|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1035707|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035708|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035709|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1035710|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035711|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1035712|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1035713|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035714|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035715|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1035716|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035717|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1035718|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1035719|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035720|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035752|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035721|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1035722|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035723|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1035724|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1035725|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035726|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035727|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1035728|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035729|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1035730|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1035731|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035732|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035733|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1035734|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035735|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1035736|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1035737|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035738|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035739|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1035740|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035741|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1035742|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1035743|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035744|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035745|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1035746|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035747|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1035748|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1035749|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035750|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035751|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1035753|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1035754|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1035755|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035756|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035757|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1035758|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035759|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1035760|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1035761|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035762|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035763|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1035764|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035765|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1035766|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1035767|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035768|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035769|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1035770|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035771|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1035772|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1035773|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035774|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035775|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1035776|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035777|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1035778|NCT00729937|O6|Outcome|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1035779|NCT00729937|O5|Outcome|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035780|NCT00729937|O4|Outcome|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035781|NCT00729937|O3|Outcome|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1035782|NCT00729937|O2|Outcome|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035783|NCT00729937|O1|Outcome|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1035784|NCT00729937|E6|Reported Event|Cellulitis, Cephalexin|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day.
1035820|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
1035785|NCT00729937|E5|Reported Event|Cellulitis, Cephalexin and TMP/SMX|Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035786|NCT00729937|E4|Reported Event|Infected Wound, Clindamycin|Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses.
1035787|NCT00729937|E3|Reported Event|Infected Wound, TMP/SMX|Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
1035788|NCT00729937|E2|Reported Event|Abscess, TMP/SMX|Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day.
1035789|NCT00729937|E1|Reported Event|Abscess, Placebo|Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day.
1035790|NCT00729924|B1|Baseline|Raltegravir: 400mg Orally Every 12 Hours for 7 Days|Raltegravir a single 400mg tablet taken orally every 12 hours for a total of 7 days.
1035791|NCT00729924|P1|Participant Flow|Raltegravir 400mg Orally Every 12 Hours for 7 Days.|Raltegravir a single 400mg tablet taken orally every 12 hours for a total of 7 days.
1035792|NCT00729924|O2|Outcome|Raltegravir: 400mg Orally Every 12 Hours for 7 Days: ABCB1 T/T|Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days in participants with ABCB1 T/T genotype.
1035793|NCT00729924|O1|Outcome|Raltegravir: 400mg Orally Every 12 Hours for 7 Days: ABCB1 C/C|Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days in participants with ABCB1 C/C genotype.
1035794|NCT00729924|O2|Outcome|Raltegravir: 400mg Orally Every 12 Hours for 7 Days (ABCB1 T/T|Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days in participants with ABCB1 T/T genotype.
1035795|NCT00729924|O1|Outcome|Raltegravir: 400mg Orally Every 12 Hours for 7 Days (ABCB1 C/C|Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days in participants with ABCB1 C/C genotype.
1035796|NCT00729924|E1|Reported Event|Raltegravir: 400mg Orally Every 12 Hours for 7 Days|Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days.
1035797|NCT00729859|B4|Baseline|Total|Total of all reporting groups
1035798|NCT00729859|B3|Baseline|Group 3: Acyline, Testosterone Gel, Anastrazole Pill|Acyline 300 μg/kg injections Day 0 & 14 + 1% Testosterone gel 10g transdermal daily for 28 days + oral anastrozole 1 mg (Arimidex) daily for 28 days
1035799|NCT00729859|B2|Baseline|Group 2: Acyline, Testosterone Gel, Placebo Pill|Acyline 300 µg/kg injections Day 0 & 14 + Testosterone gel (Testim) 10g 1% daily for 28 days + oral placebo daily for 28 days
1035800|NCT00729859|B1|Baseline|Group 1: Acyline + Placebo Gel, Placebo Pill|Acyline 300 µg/kg injections Day 0 & 14 + placebo (no active ingredients) transdermal gel daily for 28 days + oral placebo daily for 28 days
1035801|NCT00729859|P3|Participant Flow|Group 3: Acyline, Testosterone Gel, Anastrazole Pill|Acyline 300 μg/kg injections Day 0 & 14 + 1% Testosterone gel 10g transdermal daily for 28 days + oral anastrozole 1 mg (Arimidex) daily for 28 days
1035802|NCT00729859|P2|Participant Flow|Group 2: Acyline, Testosterone Gel, Placebo Pill|Acyline 300 µg/kg injections Day 0 & 14 + Testosterone gel (Testim) 10g 1% daily for 28 days + oral placebo daily for 28 days
1035803|NCT00729859|P1|Participant Flow|Group 1: Acyline + Placebo Gel, Placebo Pill|Acyline 300 µg/kg injections Day 0 & 14 + placebo (no active ingredients) transdermal gel daily for 28 days + oral placebo daily for 28 days
1035804|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Oral Anastrozole|Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
1035805|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel, Placebo Pill|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
1035806|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
1035807|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Oral Anastrozole|Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
1035808|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel, Placebo Pill|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
1035809|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
1035810|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Oral Anastrozole|Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
1035811|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel, Placebo Pill|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
1035812|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
1035813|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Oral Anastrozole|Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
1035814|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel, Placebo Pill|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
1035815|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
1035816|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Anastrozole Pill|Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
1035817|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
1035818|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
1035819|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Anastrozole Pill|Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
1035821|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
1035822|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Anastrozole|Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
1035823|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
1035824|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
1035825|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Anastrozole|Arm 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
1035826|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
1035827|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
1035828|NCT00729859|O3|Outcome|Group 3: Acyline, Testosterone Gel, Anastrazole Pill|Arm 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrazole pill 1 mg for 28 days
1035829|NCT00729859|O2|Outcome|Group 2: Acyline, Testosterone Gel|Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days
1035830|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel, Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
1035831|NCT00729859|O3|Outcome|Group 3: Acyline + T-gel + Oral Anastrozole 1mg|Acyline SQ inj. Day 0 & 14 + T-gel and anastrozole for 28 days
1035832|NCT00729859|O2|Outcome|Group 2: Acyline + T-gel 10g/Day + Placebo Pill|Acyline SQ inj. Day 0 & 14 + T-gel and placebo pill for 28 days
1035833|NCT00729859|O1|Outcome|Group 1: Acyline + Placebo Gel + Placebo Pill|Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days
1035834|NCT00729859|E3|Reported Event|Group 3: Acyline, Testosterone Gel, Anastrazole Pill|Acyline 300 μg/kg injections Day 0 & 14 + 1% Testosterone gel 10g transdermal daily for 28 days + oral anastrozole 1 mg (Arimidex) daily for 28 days
1035835|NCT00729859|E2|Reported Event|Group 2: Acyline, Testosterone Gel, Placebo Pill|Acyline 300 µg/kg injections Day 0 & 14 + Testosterone gel (Testim) 10g 1% daily for 28 days + oral placebo daily for 28 days
1035836|NCT00729859|E1|Reported Event|Group 1: Acyline + Placebo Gel, Placebo Pill|Acyline 300 µg/kg injections Day 0 & 14 + placebo (no active ingredients) transdermal gel daily for 28 days + oral placebo daily for 28 days
1035837|NCT00729846|B3|Baseline|Total|Total of all reporting groups
1035838|NCT00729846|B2|Baseline|Standard Fluence|"Standard Fluence~Bevacizumab and visudyne photodynamic therapy: Patients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2] followed by intravitreal bevacizumab (1.25 mg) on the same day after photodynamic therapy."
1035839|NCT00729846|B1|Baseline|Reduced Fluence|"Reduced Fluence~Bevacizumab and verteporfin photodynamic therapy: Patients will receive combination verteporfin with photodynamic therapy at reduced fluence [300mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy."
1035840|NCT00729846|P2|Participant Flow|Standard Fluence|"Standard Fluence~Bevacizumab and visudyne photodynamic therapy: Patients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2] followed by intravitreal bevacizumab (1.25 mg) on the same day after photodynamic therapy."
1035841|NCT00729846|P1|Participant Flow|Reduced Fluence|"Reduced Fluence~Bevacizumab and verteporfin photodynamic therapy: Patients will receive combination verteporfin with photodynamic therapy at reduced fluence [300mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy."
1035842|NCT00729846|O2|Outcome|Standard Fluence|"Standard Fluence~Bevacizumab and visudyne photodynamic therapy: Patients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2] followed by intravitreal bevacizumab (1.25 mg) on the same day after photodynamic therapy."
1035843|NCT00729846|O1|Outcome|Reduced Fluence|"Reduced Fluence~Bevacizumab and verteporfin photodynamic therapy: Patients will receive combination verteporfin with photodynamic therapy at reduced fluence [300mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy."
1035844|NCT00729846|E2|Reported Event|Standard Fluence|"Standard Fluence~Bevacizumab and visudyne photodynamic therapy: Patients will receive combination verteporfin photodynamic therapy with stand fluence [600mW/cm2] followed by intravitreal bevacizumab (1.25 mg) on the same day after photodynamic therapy."
1035845|NCT00729846|E1|Reported Event|Reduced Fluence|"Reduced Fluence~Bevacizumab and verteporfin photodynamic therapy: Patients will receive combination verteporfin with photodynamic therapy at reduced fluence [300mw/cm2] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy."
1035846|NCT00729833|B1|Baseline|Figitumumab + Sunitinib (All Combined)|All participants who received at least one dose of figitumumab plus sunitinib.
1035847|NCT00729833|P4|Participant Flow|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of continuous daily dosing followed by 1 week off, until disease progression or unacceptable toxicity.
1035848|NCT00729833|P3|Participant Flow|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a continuous daily dosing (CDD) schedule, until disease progression or unacceptable toxicity.
1035849|NCT00729833|P2|Participant Flow|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a continuous daily dosing (CDD) schedule, until disease progression or unacceptable toxicity.
1035850|NCT00729833|P1|Participant Flow|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab (CP-751,871) 10 milligram/kilogram (mg/kg) intravenous (IV) on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a continuous daily dosing (CDD) schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participant experienced a dose-limiting toxicity (DLT).
1035957|NCT00729521|B4|Baseline|Total|Total of all reporting groups
1046757|NCT00703326|B3|Baseline|Total|Total of all reporting groups
1035851|NCT00729833|O4|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of CDD followed by 1 week off, until disease progression or unacceptable toxicity.
1035852|NCT00729833|O3|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
1035853|NCT00729833|O2|Outcome|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
1035854|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participants experienced a DLT.
1035855|NCT00729833|O4|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of CDD followed by 1 week off, until disease progression or unacceptable toxicity.
1035856|NCT00729833|O3|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
1035857|NCT00729833|O2|Outcome|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
1035858|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participants experienced a DLT.
1035859|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
1035860|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
1035861|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
1035862|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
1035863|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
1035864|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
1035865|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
1035866|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
1035867|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion)|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule, until disease progression or unacceptable toxicity.
1035868|NCT00729833|O4|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of CDD followed by 1 week off, until disease progression or unacceptable toxicity.
1035869|NCT00729833|O3|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
1035870|NCT00729833|O2|Outcome|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
1035871|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participants experienced a DLT.
1035872|NCT00729833|O4|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of CDD followed by 1 week off, until disease progression or unacceptable toxicity.
1035873|NCT00729833|O3|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
1035874|NCT00729833|O2|Outcome|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
1035875|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participants experienced a DLT.
1035876|NCT00729833|O4|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of CDD followed by 1 week off, until disease progression or unacceptable toxicity.
1035877|NCT00729833|O3|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
1035878|NCT00729833|O2|Outcome|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
1035879|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participants experienced a DLT.
1035880|NCT00729833|O4|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of CDD followed by 1 week off, until disease progression or unacceptable toxicity.
1035881|NCT00729833|O3|Outcome|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
1035882|NCT00729833|O2|Outcome|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
1035883|NCT00729833|O1|Outcome|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participants experienced a DLT.
1035884|NCT00729833|E4|Reported Event|Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1|Figitumumab 20 mg/kg on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle with 2 weeks of CDD followed by 1 week off, until disease progression or unacceptable toxicity.
1035885|NCT00729833|E3|Reported Event|Figitumumab 20 mg/kg + Sunitinib 25 mg CDD|Figitumumab 20 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
1035886|NCT00729833|E2|Reported Event|Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 37.5 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule until disease progression or unacceptable toxicity.
1035887|NCT00729833|E1|Reported Event|Figitumumab 10 mg/kg + Sunitinib 25 mg CDD|Figitumumab 10 mg/kg IV on Day 1 of each 3-week cycle plus sunitinib 25 mg oral capsule on Day 1 of each 3-week cycle on a CDD schedule. Dose escalation proceeded to the next cohort if 0/3 or 1/6 participants experienced a DLT.
1035888|NCT00729807|B1|Baseline|Treatment Arm|
1035889|NCT00729807|P1|Participant Flow|Treatment Arm|
1035890|NCT00729807|O1|Outcome|Treatment Arm|Pentamidine
1035891|NCT00729807|E1|Reported Event|Treatment Arm|Pentamidine
1035892|NCT00729781|B1|Baseline|Polyester Implants|There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.
1035893|NCT00729781|P1|Participant Flow|Polyester Implants|There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.
1035894|NCT00729781|O1|Outcome|Polyester Implants|There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.
1035895|NCT00729781|O1|Outcome|Polyester Implants|There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.
1035896|NCT00729781|O1|Outcome|Polyester Implants|There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.
1035897|NCT00729781|E1|Reported Event|Polyester Implants|There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information.
1035898|NCT00729690|B4|Baseline|Total|Total of all reporting groups
1035899|NCT00729690|B3|Baseline|3 Placebo|Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
1035900|NCT00729690|B2|Baseline|2 Single-dose Pregabalin|Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
1035901|NCT00729690|B1|Baseline|1 Multi-Dose Pregabalin|Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
1035902|NCT00729690|P3|Participant Flow|3 Placebo|Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
1035903|NCT00729690|P2|Participant Flow|2 Single-dose Pregabalin|Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
1035904|NCT00729690|P1|Participant Flow|1 Multi-Dose Pregabalin|Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
1035905|NCT00729690|O3|Outcome|3 Placebo|Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
1035906|NCT00729690|O2|Outcome|2 Single-dose Pregabalin|Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
1035907|NCT00729690|O1|Outcome|1 Multi-Dose Pregabalin|Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
1035908|NCT00729690|O3|Outcome|3 Placebo|Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
1035909|NCT00729690|O2|Outcome|2 Single-dose Pregabalin|Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
1035910|NCT00729690|O1|Outcome|1 Multi-Dose Pregabalin|Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
1035911|NCT00729690|O3|Outcome|3 Placebo|Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
1035912|NCT00729690|O2|Outcome|2 Single-dose Pregabalin|Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
1035913|NCT00729690|O1|Outcome|1 Multi-Dose Pregabalin|Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
1035914|NCT00729690|O3|Outcome|3 Placebo|Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
1035915|NCT00729690|O2|Outcome|2 Single-dose Pregabalin|Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
1035916|NCT00729690|O1|Outcome|1 Multi-Dose Pregabalin|Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
1035917|NCT00729690|E3|Reported Event|3 Placebo|Placebo: patients receive matching placebo at the same 3 time points as Groups 1 and 2 (orally 1 hour prior to surgery and then repeat doses at 12 and 24 hours after initial dose.)
1035918|NCT00729690|E2|Reported Event|2 Single-dose Pregabalin|Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
1035919|NCT00729690|E1|Reported Event|1 Multi-Dose Pregabalin|Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
1035920|NCT00729677|B1|Baseline|Patients With Colorectal Cancer Starting Chemotherapy|patients starting chemotherapy for stage 3 or 4 colorectal cancer on regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
1035921|NCT00729677|P1|Participant Flow|Patients With Colorectal Cancer Starting Chemotherapy|patients starting chemotherapy for stage 3 or 4 colorectal cancer on regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
1035922|NCT00729677|O2|Outcome|Participants on 3-drug Regimen|patients starting chemotherapy for stage 3 or 4 colorectal cancer receiving 2-drug antiemetic regimens who reported nausea.
1035923|NCT00729677|O1|Outcome|Participants on 2-drug Regimen|patients starting chemotherapy for stage 3 or 4 colorectal cancer receiving 2-drug antiemetic regimens who reported nausea.
1035924|NCT00729677|O2|Outcome|Participants With No History of Nausea|patients starting chemotherapy for stage 3 or 4 colorectal cancer receiving regimens containing oxaliplatin who had no history of nausea.
1035925|NCT00729677|O1|Outcome|Participants With History of Nausea|patients starting chemotherapy for stage 3 or 4 colorectal cancer receiving regimens containing oxaliplatin who had history of nausea.
1035926|NCT00729677|O1|Outcome|Patients With Colorectal Cancer Starting Chemotherapy|patients starting chemotherapy for stage 3 or 4 colorectal cancer on regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
1035927|NCT00729677|O3|Outcome|Transgender|transgender subject starting chemotherapy for stage 3 or 4 colorectal cancer containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
1035928|NCT00729677|O2|Outcome|Males|males starting chemotherapy for stage 3 or 4 colorectal cancer containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
1035929|NCT00729677|O1|Outcome|Females|females starting chemotherapy for stage 3 or 4 colorectal cancer with regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
1035930|NCT00729677|E1|Reported Event|Patients With Colorectal Cancer Starting Chemotherapy|patients starting chemotherapy for stage 3 or 4 colorectal cancer on regimens containing oxaliplatin. The chemotherapy is not part of the study but instead is initiated as standard care.
1035931|NCT00729651|B3|Baseline|Total|Total of all reporting groups
1035932|NCT00729651|B2|Baseline|Fosamax|Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day]), 16 weeks
1035933|NCT00729651|B1|Baseline|Fosamax Plus D|Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks
1035934|NCT00729651|P2|Participant Flow|Fosamax|Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day]), 16 weeks
1035935|NCT00729651|P1|Participant Flow|Fosamax Plus D|Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks
1035936|NCT00729651|O2|Outcome|Fosamax|Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day], 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
1037661|NCT00724594|O3|Outcome|NAC Maternal|Mothers treated with N-acetylcysteine prior to delivery
1035937|NCT00729651|O1|Outcome|Fosamax Plus D|Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
1035938|NCT00729651|O2|Outcome|Fosamax|Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day], 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
1035939|NCT00729651|O1|Outcome|Fosamax Plus D|Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
1035940|NCT00729651|O2|Outcome|Fosamax|Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day], 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
1035941|NCT00729651|O1|Outcome|Fosamax Plus D|Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
1035942|NCT00729651|O2|Outcome|Fosamax|Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day], 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
1035943|NCT00729651|O1|Outcome|Fosamax Plus D|Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria
1035944|NCT00729651|E2|Reported Event|Fosamax|Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day]), 16 weeks and patients who received drugs at least once after randomization and was analyzed according to the actually administered study drugs
1035945|NCT00729651|E1|Reported Event|Fosamax Plus D|Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks and patients who received drugs at least once after randomization and was analyzed according to the actually administered study drugs
1035946|NCT00729612|B1|Baseline|Treatment (Nab-paclitaxel, Carboplatin)|"Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~carboplatin~paclitaxel albumin-stabilized nanoparticle formulation~protein expression analysis~immunoenzyme technique~immunohistochemistry staining method~laboratory biomarker analysis"
1035947|NCT00729612|P1|Participant Flow|Treatment (Nab-paclitaxel, Carboplatin)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
1035948|NCT00729612|O1|Outcome|Treatment (Nab-paclitaxel, Carboplatin)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
1035949|NCT00729612|O1|Outcome|Treatment (Nab-paclitaxel, Carboplatin)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
1035950|NCT00729612|O1|Outcome|Treatment (Nab-paclitaxel, Carboplatin)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
1035951|NCT00729612|O1|Outcome|Treatment (Nab-paclitaxel, Carboplatin)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
1035952|NCT00729612|E1|Reported Event|Treatment (Nab-paclitaxel, Carboplatin)|Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
1035953|NCT00729560|B1|Baseline|Flutamide Treated and Placebo Control|Flutamide treated: 250 mg twice daily for 4 weeks or Placebo control: twice daily for 4 weeks. Study was terminated due to insufficient enrollment. Randomization is unknown as study was terminated prior to unblinding and no key can be found. Consequently, we are unable to differentiate between treated and control subjects.
1035954|NCT00729560|P1|Participant Flow|Flutamide and Placebo Control Subjects|Number of participants randomized to each Arm/Group is unknown, study was terminated before unblinding and no key exists.
1035955|NCT00729560|O1|Outcome|Flutamide and Placebo Control Subjects|Number of participants randomized to each Arm/Group is unknown, study was terminated before unblinding and no key exists.
1035956|NCT00729560|E1|Reported Event|Flutamide Treated and Placebo Control Subjects|Flutamide: 250 mg twice daily for 4 weeks or Placebo: twice daily for 4 weeks
1035958|NCT00729521|B3|Baseline|Facilitative System|"a Facilitative System group of five communities and their residents over 65 years of age receiving support in addition to the resources provided the Standard Program group~facilitative system: The facilitative system links communities with academic partners to provide communities with the skills and resources needed to help facilitate the community health improvement process. The system identifies what assets are available within communities, as well as the skills and resources needed to work through the community health improvement process. The facilitative system will then provide technical assistance, best practices guides, and direct consultation in carrying out all phases of the community health improvement process. This information is designed to increase community capacity in community assessment, coalition development, accessing and interpreting local injury prevention data, searching and selecting evidence-based research, and program planning and evaluation."
1035959|NCT00729521|B2|Baseline|Standard Program|"a Standard Program group of five communities and their residents over 65 years of age receiving modest funding to implement an evidence-based fall prevention program in their local community;~Standard Program: a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;"
1035960|NCT00729521|B1|Baseline|Control|a control group of 10 communities and their residents over 65 years of age receiving no special resources or guidance related to fall injury prevention or the community health improvement process;
1035961|NCT00729521|P3|Participant Flow|Facilitative System|"a Facilitative System group receiving facilitative system support in addition to the resources provided the Standard Program group~facilitative system: The facilitative system links communities with academic partners to provide communities with the skills and resources needed to help facilitate the community health improvement process. The system identifies what assets are available within communities, as well as the skills and resources needed to work through the community health improvement process. The facilitative system will then provide technical assistance, best practices guides, and direct consultation in carrying out all phases of the community health improvement process. This information is designed to increase community capacity in community assessment, coalition development, accessing and interpreting local injury prevention data, searching and selecting evidence-based research, and program planning and evaluation."
1035962|NCT00729521|P2|Participant Flow|Standard Program|"a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;~Standard Program: a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;"
1035963|NCT00729521|P1|Participant Flow|Control|a control group receiving no special resources or guidance related to fall injury prevention or the community health improvement process;
1035964|NCT00729521|O3|Outcome|Facilitative System|"a Facilitative System group receiving facilitative system support in addition to the resources provided the Standard Program group~facilitative system: The facilitative system links communities with academic partners to provide communities with the skills and resources needed to help facilitate the community health improvement process. The system identifies what assets are available within communities, as well as the skills and resources needed to work through the community health improvement process. The facilitative system will then provide technical assistance, best practices guides, and direct consultation in carrying out all phases of the community health improvement process. This information is designed to increase community capacity in community assessment, coalition development, accessing and interpreting local injury prevention data, searching and selecting evidence-based research, and program planning and evaluation."
1035965|NCT00729521|O2|Outcome|Standard Program|"a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;~Standard Program: a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;"
1035966|NCT00729521|O1|Outcome|Control|a control group receiving no special resources or guidance related to fall injury prevention or the community health improvement process;
1035967|NCT00729521|E3|Reported Event|Facilitative System|"a Facilitative System group receiving facilitative system support in addition to the resources provided the Standard Program group~facilitative system: The facilitative system links communities with academic partners to provide communities with the skills and resources needed to help facilitate the community health improvement process. The system identifies what assets are available within communities, as well as the skills and resources needed to work through the community health improvement process. The facilitative system will then provide technical assistance, best practices guides, and direct consultation in carrying out all phases of the community health improvement process. This information is designed to increase community capacity in community assessment, coalition development, accessing and interpreting local injury prevention data, searching and selecting evidence-based research, and program planning and evaluation."
1035968|NCT00729521|E2|Reported Event|Standard Program|"a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;~Standard Program: a Standard Program group receiving modest funding to implement an evidence-based fall prevention program in their local community;"
1035969|NCT00729521|E1|Reported Event|Control|a control group receiving no special resources or guidance related to fall injury prevention or the community health improvement process;
1035970|NCT00729482|B1|Baseline|RAD001|Treatment Arm (RAD001)
1035971|NCT00729482|P1|Participant Flow|RAD001|Treatment Arm (RAD001)
1035972|NCT00729482|O1|Outcome|RAD001|Treatment Arm (RAD001)
1035973|NCT00729482|O1|Outcome|RAD001|Treatment Arm (RAD001)
1035974|NCT00729482|O1|Outcome|RAD001|Treatment Arm (RAD001)
1035975|NCT00729482|O1|Outcome|RAD001|Treatment Arm (RAD001)
1035976|NCT00729482|E1|Reported Event|RAD001|Treatment Arm (RAD001)
1035977|NCT00729469|B3|Baseline|Total|Total of all reporting groups
1035978|NCT00729469|B2|Baseline|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1035979|NCT00729469|B1|Baseline|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1036068|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
1035980|NCT00729469|P2|Participant Flow|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1035981|NCT00729469|P1|Participant Flow|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1035982|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1035983|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1035984|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1035985|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1035986|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1035987|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1035988|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1035989|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1035990|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1035991|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1035992|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1035993|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1035994|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1035995|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1035996|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1035997|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1035998|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1035999|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1036000|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1036001|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1036002|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1036003|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1036004|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1036005|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1036006|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1036007|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1036008|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1036009|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1036010|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1036011|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1036012|NCT00729469|O2|Outcome|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1036013|NCT00729469|O1|Outcome|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1036014|NCT00729469|E2|Reported Event|Subjects on Ospemifene 60 mg/Day|Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1036015|NCT00729469|E1|Reported Event|Subjects on Placebo|Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
1036016|NCT00729430|B3|Baseline|Total|Total of all reporting groups
1036017|NCT00729430|B2|Baseline|Placebo Arm|"Participants will receive placebo for 6 months.~Placebo: Placebo tablets taken orally once per day for 6 months"
1036018|NCT00729430|B1|Baseline|High Dose Omega-3 Fatty Acid Arm|"Participants will receive a highly purified form of omega-3 fatty acids for 6 months.~Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months"
1036019|NCT00729430|P2|Participant Flow|Placebo Arm|"Participants will receive placebo for 6 months.~Placebo: Placebo tablets taken orally once per day for 6 months"
1036020|NCT00729430|P1|Participant Flow|High Dose Omega-3 Fatty Acid Arm|"Participants will receive a highly purified form of omega-3 fatty acids for 6 months.~Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months"
1036021|NCT00729430|O2|Outcome|Placebo Arm|"Participants will receive placebo for 6 months.~Placebo: Placebo tablets taken orally once per day for 6 months"
1036022|NCT00729430|O1|Outcome|High Dose Omega-3 Fatty Acids Arm|"Participants will receive a highly purified form of omega-3 fatty acids for 6 months.~Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months"
1036023|NCT00729430|O2|Outcome|Placebo Arm|"Participants will receive placebo for 6 months.~Placebo: Placebo tablets taken orally once per day for 6 months"
1036024|NCT00729430|O1|Outcome|High Dose Omega-3 Fatty Acids Arm|"Participants will receive a highly purified form of omega-3 fatty acids for 6 months.~Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months"
1036025|NCT00729430|O2|Outcome|Placebo Arm|"Participants will receive placebo for 6 months.~Placebo: Placebo tablets taken orally once per day for 6 months"
1036026|NCT00729430|O1|Outcome|High Dose Omega-3 Fatty Acid Arm|"Participants will receive a highly purified form of omega-3 fatty acids for 6 months.~Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months"
1036027|NCT00729430|O2|Outcome|Placebo Arm|"Participants will receive placebo for 6 months.~Placebo: Placebo tablets taken orally once per day for 6 months"
1036028|NCT00729430|O1|Outcome|High Dose Omega-3 Fatty Acid Arm|"Participants will receive a highly purified form of omega-3 fatty acids for 6 months.~Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months"
1036029|NCT00729430|E2|Reported Event|Placebo Arm|"Participants will receive placebo for 6 months.~Placebo: Placebo tablets taken orally once per day for 6 months"
1036030|NCT00729430|E1|Reported Event|High Dose Omega-3 Fatty Acids Arm|"Participants will receive a highly purified form of omega-3 fatty acids for 6 months.~Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months"
1036031|NCT00729365|B4|Baseline|Total|Total of all reporting groups
1036032|NCT00729365|B3|Baseline|Non-Dippers - Ramipril|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given ACE inhibitor (study medication).~Ramipril: ACE inhibitor known as Ramipril~Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into this group and given an ACE inhibitor (study medication). Therefore, the Non-Dippers groups II and III will be randomized to receive either drug or placebo."
1036033|NCT00729365|B2|Baseline|Non-Dippers - Placebo|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given placebo.~Placebo: Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into the control group and given Placebo."
1036034|NCT00729365|B1|Baseline|Dippers - Placebo|"Subjects with normal nighttime blood pressure profile that decreases at night (Dippers). This group are all given placebo.~Placebo: Dippers (category of subjects with a nighttime dip in blood pressure) will all be given Placebo. Control group."
1036035|NCT00729365|P3|Participant Flow|Non-Dippers - Ramipril|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given ACE inhibitor (study medication).~Ramipril: ACE inhibitor known as Ramipril~Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into this group and given an ACE inhibitor (study medication). Therefore, the Non-Dippers groups II and III will be randomized to receive either drug or placebo."
1036036|NCT00729365|P2|Participant Flow|Non-dippers - Placebo|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given placebo.~Placebo: Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into the control group and given Placebo."
1036037|NCT00729365|P1|Participant Flow|Dippers - Placebo Group|"Subjects with normal nighttime blood pressure profile that decreases at night (Dippers). This group are all given placebo.~Placebo: Dippers (category of subjects with a nighttime dip in blood pressure) will all be given Placebo. Control group."
1037662|NCT00724594|O2|Outcome|Control Infants|Infants treated with saline
1036038|NCT00729365|O3|Outcome|Non-Dippers - Ramipril|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given ACE inhibitor (study medication).~Ramipril: ACE inhibitor known as Ramipril~Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into this group and given an ACE inhibitor (study medication). Therefore, the Non-Dippers groups II and III will be randomized to receive either drug or placebo."
1036039|NCT00729365|O2|Outcome|Non-Dippers - Placebo|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given placebo.~Placebo: Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into the control group and given Placebo."
1036040|NCT00729365|O1|Outcome|Dippers - Placebo|"Subjects with normal nighttime blood pressure profile that decreases at night (Dippers). This group are all given placebo.~Placebo: Dippers (category of subjects with a nighttime dip in blood pressure) will all be given Placebo. Control group."
1036041|NCT00729365|O3|Outcome|Non-Dippers - Ramipril|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given ACE inhibitor (study medication).~Ramipril: ACE inhibitor known as Ramipril~Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into this group and given an ACE inhibitor (study medication). Therefore, the Non-Dippers groups II and III will be randomized to receive either drug or placebo."
1036042|NCT00729365|O2|Outcome|Non-dippers - Placebo|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given placebo.~Placebo: Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into the control group and given Placebo."
1036043|NCT00729365|O1|Outcome|Dippers - Placebo Group|"Subjects with normal nighttime blood pressure profile that decreases at night (Dippers). This group are all given placebo.~Placebo: Dippers (category of subjects with a nighttime dip in blood pressure) will all be given Placebo. Control group."
1036044|NCT00729365|E3|Reported Event|Non-Dippers - Ramipril|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given ACE inhibitor (study medication).~Ramipril: ACE inhibitor known as Ramipril~Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into this group and given an ACE inhibitor (study medication). Therefore, the Non-Dippers groups II and III will be randomized to receive either drug or placebo."
1036045|NCT00729365|E2|Reported Event|Non-Dippers - Placebo|"Subjects with nighttime blood pressure that does not drop during the night (non-dippers). This group will be given placebo.~Placebo: Subjects with nighttime blood pressure that does not drop during the night (non-dippers) maybe randomized into the control group and given Placebo."
1036046|NCT00729365|E1|Reported Event|Dippers - Placebo|"Subjects with normal nighttime blood pressure profile that decreases at night (Dippers). This group are all given placebo.~Placebo: Dippers (category of subjects with a nighttime dip in blood pressure) will all be given Placebo. Control group."
1036047|NCT00729326|B3|Baseline|Total|Total of all reporting groups
1036048|NCT00729326|B2|Baseline|Sitagliptin Followed By Exenatide|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks. Followed by exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
1036049|NCT00729326|B1|Baseline|Exenatide Followed By Sitagliptin|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks. Followed by exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
1036050|NCT00729326|P2|Participant Flow|Sitagliptin Followed By Exenatide|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks. Followed by exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
1036051|NCT00729326|P1|Participant Flow|Exenatide Followed By Sitagliptin|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks. Followed by exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
1036052|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
1036053|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
1036054|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
1036055|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
1036056|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
1036057|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
1036058|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
1036059|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
1036060|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
1036061|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
1036062|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
1036063|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
1036064|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
1036065|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
1036066|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
1036067|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
1036070|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
1036071|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
1036072|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
1036073|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
1036074|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
1036075|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
1036076|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
1036077|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
1036078|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
1036079|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
1036080|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
1036081|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
1036082|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
1036083|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
1036084|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
1036085|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
1036086|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
1036087|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
1036088|NCT00729326|O2|Outcome|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
1036089|NCT00729326|O1|Outcome|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
1036090|NCT00729326|E2|Reported Event|Sitagliptin|Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
1036091|NCT00729326|E1|Reported Event|Exenatide|Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
1036092|NCT00729248|B1|Baseline|All Participants|"All participants (6 donors, 6 recipients) had blood drawn before renal transplant surgery. Peripheral mononuclear cells (PBMC) were isolated from the blood, and were cultured in the following combination:~Recipient PMBC + Donor PBMC + No drug Recipient PMBC + Donor PBMC + Tacrolimus (TAC) Recipient PMBC + Donor PBMC + Sirolimus (SRL)"
1036093|NCT00729248|P1|Participant Flow|Participants|12 participants were recruited/consented for the study. 2 subjects (donor/recipient pair) were withdrawn from the study. Ten participants (5 donors, 5 recipients) had blood drawn before renal transplant surgery. Peripheral mononuclear cells (PBMC) were isolated from the blood, and were cultured in the following combination: Recipient PMBC + Donor PBMC + Sirolimus (SRL)
1036094|NCT00729248|O2|Outcome|MLRs in the Presence of SRL|"All participants (5 donors, 5 recipietns) had blood drawn before renal transplant surgery. Peripheral mononuclear cells (PBMC) were isolated from the blood, and were cultured in teh following combination:~Recipient PMBC + Donor PBMC + Sirolimus (SRL)"
1036095|NCT00729248|O1|Outcome|MLRs in the Presence of TAC|"All participants (5 donors, 5 recipients) had blood drawn before renal transplant surgery. Peripheral mononuclear cells (PBMC) were isolated from the blood, and were cultured in the following combination:~REcipient PMBC + Donor PBMC + Tacrolimus (TAC)"
1036096|NCT00729248|E1|Reported Event|All Participants|All participants (6 donors, 6 recipients) had blood drawn before renal transplant surgery. Peripheral mononuclear cells (PBMC) were isolated from the blood, and were cultured in the following combination: Recipient PMBC + Donor PBMC + Sirolimus (SRL)
1036097|NCT00729183|B3|Baseline|Total|Total of all reporting groups
1036098|NCT00729183|B2|Baseline|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036099|NCT00729183|B1|Baseline|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036100|NCT00729183|P2|Participant Flow|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036101|NCT00729183|P1|Participant Flow|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036102|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036103|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036173|NCT00728910|O2|Outcome|Atorvastatin+ABT335|Subjects received atorvastatin 10 mg daily and ABT335 135 mg daily by mouth for 8 weeks followed by an oral fat tolerance test.
1036104|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036105|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036106|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036107|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036108|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036109|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036110|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036111|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036112|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036113|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036114|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036115|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036116|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036117|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036118|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036119|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036120|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036121|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036122|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036123|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036124|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036125|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036126|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036127|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036128|NCT00729183|O2|Outcome|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036430|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
1036129|NCT00729183|O1|Outcome|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036130|NCT00729183|E2|Reported Event|Placebo|Participants received matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036131|NCT00729183|E1|Reported Event|Odanacatib 50 mg|Participants received 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also received 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
1036132|NCT00729157|B1|Baseline|Treatment (Ziv-aflibercept and Fludeoxyglucose F 18)|Patients receive aflibercept 4mg/kg IV over 1 hour on day 1. Treatment repeats every 14 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients experiencing clear clinical benefit with aflibercept may continue treatment beyond 12 months, at the discretion of the study sponsor. Patients undergo FDG-PET scans at baseline and after 8 weeks of study therapy to evaluate changes in FDG avidity on FDG-PET scan. Blood samples are obtained at baseline and periodically during study for laboratory correlative studies. Samples are examined for pretreatment serum VEGF concentration, thyroglobulin levels (when elevated), serum pharmacokinetics of aflibercept by ELISA, and anti-aflibercept antibodies.
1036133|NCT00729157|P1|Participant Flow|Treatment (Ziv-aflibercept and Fludeoxyglucose F 18)|Patients receive aflibercept 4mg/kg IV over 1 hour on day 1. Treatment repeats every 14 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients experiencing clear clinical benefit with aflibercept may continue treatment beyond 12 months, at the discretion of the study sponsor. Patients undergo FDG-PET scans at baseline and after 8 weeks of study therapy to evaluate changes in FDG avidity on FDG-PET scan. Blood samples are obtained at baseline and periodically during study for laboratory correlative studies. Samples are examined for pretreatment serum VEGF concentration, thyroglobulin levels (when elevated), serum pharmacokinetics of aflibercept by ELISA, and anti-aflibercept antibodies.
1036134|NCT00729157|O1|Outcome|Treatment (Ziv-aflibercept and Fludeoxyglucose F 18)|Patients receive aflibercept 4mg/kg IV over 1 hour on day 1. Treatment repeats every 14 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients experiencing clear clinical benefit with aflibercept may continue treatment beyond 12 months, at the discretion of the study sponsor. Patients undergo FDG-PET scans at baseline and after 8 weeks of study therapy to evaluate changes in FDG avidity on FDG-PET scan. Blood samples are obtained at baseline and periodically during study for laboratory correlative studies. Samples are examined for pretreatment serum VEGF concentration, thyroglobulin levels (when elevated), serum pharmacokinetics of aflibercept by ELISA, and anti-aflibercept antibodies.
1036135|NCT00729157|O1|Outcome|Treatment (Ziv-aflibercept and Fludeoxyglucose F 18)|Patients receive aflibercept 4mg/kg IV over 1 hour on day 1. Treatment repeats every 14 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients experiencing clear clinical benefit with aflibercept may continue treatment beyond 12 months, at the discretion of the study sponsor. Patients undergo FDG-PET scans at baseline and after 8 weeks of study therapy to evaluate changes in FDG avidity on FDG-PET scan. Blood samples are obtained at baseline and periodically during study for laboratory correlative studies. Samples are examined for pretreatment serum VEGF concentration, thyroglobulin levels (when elevated), serum pharmacokinetics of aflibercept by ELISA, and anti-aflibercept antibodies.
1036136|NCT00729157|O1|Outcome|Treatment (Ziv-aflibercept and Fludeoxyglucose F 18)|Patients receive aflibercept 4mg/kg IV over 1 hour on day 1. Treatment repeats every 14 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients experiencing clear clinical benefit with aflibercept may continue treatment beyond 12 months, at the discretion of the study sponsor. Patients undergo FDG-PET scans at baseline and after 8 weeks of study therapy to evaluate changes in FDG avidity on FDG-PET scan. Blood samples are obtained at baseline and periodically during study for laboratory correlative studies. Samples are examined for pretreatment serum VEGF concentration, thyroglobulin levels (when elevated), serum pharmacokinetics of aflibercept by ELISA, and anti-aflibercept antibodies.
1036137|NCT00729157|O1|Outcome|Treatment (Ziv-aflibercept and Fludeoxyglucose F 18)|Patients receive aflibercept 4mg/kg IV over 1 hour on day 1. Treatment repeats every 14 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients experiencing clear clinical benefit with aflibercept may continue treatment beyond 12 months, at the discretion of the study sponsor. Patients undergo FDG-PET scans at baseline and after 8 weeks of study therapy to evaluate changes in FDG avidity on FDG-PET scan. Blood samples are obtained at baseline and periodically during study for laboratory correlative studies. Samples are examined for pretreatment serum VEGF concentration, thyroglobulin levels (when elevated), serum pharmacokinetics of aflibercept by ELISA, and anti-aflibercept antibodies.
1036138|NCT00729157|O1|Outcome|Treatment (Ziv-aflibercept and Fludeoxyglucose F 18)|Patients receive aflibercept 4mg/kg IV over 1 hour on day 1. Treatment repeats every 14 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients experiencing clear clinical benefit with aflibercept may continue treatment beyond 12 months, at the discretion of the study sponsor. Patients undergo FDG-PET scans at baseline and after 8 weeks of study therapy to evaluate changes in FDG avidity on FDG-PET scan. Blood samples are obtained at baseline and periodically during study for laboratory correlative studies. Samples are examined for pretreatment serum VEGF concentration, thyroglobulin levels (when elevated), serum pharmacokinetics of aflibercept by ELISA, and anti-aflibercept antibodies.
1036139|NCT00729157|E1|Reported Event|Treatment (Ziv-aflibercept and Fludeoxyglucose F 18)|Patients receive aflibercept 4mg/kg IV over 1 hour on day 1. Treatment repeats every 14 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients experiencing clear clinical benefit with aflibercept may continue treatment beyond 12 months, at the discretion of the study sponsor. Patients undergo FDG-PET scans at baseline and after 8 weeks of study therapy to evaluate changes in FDG avidity on FDG-PET scan. Blood samples are obtained at baseline and periodically during study for laboratory correlative studies. Samples are examined for pretreatment serum VEGF concentration, thyroglobulin levels (when elevated), serum pharmacokinetics of aflibercept by ELISA, and anti-aflibercept antibodies.
1036140|NCT00728988|B3|Baseline|Total|Total of all reporting groups
1036174|NCT00728910|O1|Outcome|Atorvastatin|Subjects received atorvastatin 10 mg daily by mouth for 4 weeks followed by an oral fat tolerance test
1036141|NCT00728988|B2|Baseline|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
1036142|NCT00728988|B1|Baseline|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
1036143|NCT00728988|P2|Participant Flow|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
1036144|NCT00728988|P1|Participant Flow|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
1036145|NCT00728988|O2|Outcome|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
1036146|NCT00728988|O1|Outcome|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
1036147|NCT00728988|O2|Outcome|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
1036148|NCT00728988|O1|Outcome|Atorvastatin|Atorvastatin 80 mg 12 hours pre-PCI and 40 mg 2 hours pre-percutaneous coronary intervention (PCI), and usual care.
1036149|NCT00728988|O2|Outcome|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
1036150|NCT00728988|O1|Outcome|Atorvastatin|Atorvastatin 80 mg 12 hours pre-PCI and 40 mg 2 hours pre-percutaneous coronary intervention (PCI), and usual care.
1036151|NCT00728988|O2|Outcome|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
1036152|NCT00728988|O1|Outcome|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
1036153|NCT00728988|O2|Outcome|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
1036154|NCT00728988|O1|Outcome|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
1036155|NCT00728988|O2|Outcome|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
1036156|NCT00728988|O1|Outcome|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
1036157|NCT00728988|O2|Outcome|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
1036158|NCT00728988|O1|Outcome|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
1036159|NCT00728988|E2|Reported Event|Usual Care|Aspirin 200-300 mg pre-PCI and 100-200 mg daily thereafter; clopidogrel 300 mg loading dose at least 3 hours pre-PCI and 75 mg thereafter; subcutaneous heparin: enoxaparin 1 mg/kg every 12 hours pre-PCI or dalteparin 120 IU/kg every 12 hours pre-PCI; and atorvastatin 40 mg daily after PCI for 30 days.
1036160|NCT00728988|E1|Reported Event|Atorvastatin|Atorvastatin 80 mg 12 hours pre- percutaneous coronary intervention (PCI) and 40 mg 2 hours PCI, and usual care.
1036161|NCT00728962|B1|Baseline|Osseotite Certain Prevail Implant|Internal connection implant with an expanded platform and lateralization with a tapered apex
1036162|NCT00728962|P1|Participant Flow|Osseotite Certain Prevail Implant|Internal connection implant with an expanded platform and lateralization with a tapered apex
1036163|NCT00728962|O1|Outcome|Osseotite Certain Prevail Implant|Internal connection implant with an expanded platform and lateralization with a tapered apex
1036164|NCT00728962|E1|Reported Event|Osseotite Certain Prevail Implant|Internal connection implant with an expanded platform and lateralization with a tapered apex
1036165|NCT00728923|B1|Baseline|Minocycline|minocycline 100mg bid for 12 weeks
1036166|NCT00728923|P1|Participant Flow|Minocycline|minocycline 100mg bid for 12 weeks
1036167|NCT00728923|O1|Outcome|Minocycline|Subjects received minocycline at 50mg BID (twice daily) for 3 days and then at 100mg BID for 12 weeks in addition to their SRI (serotonin reuptake inhibitor).
1036168|NCT00728923|O1|Outcome|Minocycline|Subjects received minocycline at 50mg BID (twice daily) for 3 days and then at 100mg BID for 12 weeks in addition to their SRI (serotonin reuptake inhibitor).
1036169|NCT00728923|E1|Reported Event|Minocycline|minocycline 100mg bid for 12 weeks
1036170|NCT00728910|B1|Baseline|Group 1|All participants received atorvastatin 10 mg/day for 4 weeks, followed by sequential addition of ABT335 135 mg/day for 8 weeks, and ER niacin 2000 mg/day for 10 weeks.
1036171|NCT00728910|P1|Participant Flow|Atorvastatin/ABT335/Niaspan|All participants received atorvastatin 10 mg/day for 4 weeks, followed by sequential addition of ABT335 135 mg/day for 8 weeks, and ER niacin 2000 mg/day for 10 weeks, for a total study duration of 22 weeks
1036172|NCT00728910|O3|Outcome|Atorvastatin+ABT335+Niaspan|Subjects received atorvastatin 10 mg daily, ABT335 135 mg and Niaspan 2000 mg daily by mouth for 10 weeks followed by an oral fat tolerance test.
1049601|NCT00697515|O2|Outcome|Placebo|Placebo is administered once-daily
1036175|NCT00728910|O3|Outcome|Atorvastatin+ABT335+Niaspan|Subjects received atorvastatin 10 mg daily, ABT335 135 mg and Niaspan 2000 mg daily by mouth for 10 weeks.
1036176|NCT00728910|O2|Outcome|Atorvastatin+ABT335|Subjects received atorvastatin 10 mg daily and ABT335 135 mg daily by mouth for 8 weeks.
1036177|NCT00728910|O1|Outcome|Atorvastatin|Subjects received atorvastatin 10 mg daily by mouth for 4 weeks followed by apo-A1 kinetics
1036178|NCT00728910|O3|Outcome|Atorvastatin+ABT335+Niaspan|Subjects received atorvastatin 10 mg daily, ABT335 135 mg and Niaspan 2000 mg daily by mouth for 10 weeks.
1036179|NCT00728910|O2|Outcome|Atorvastatin+ABT335|Subjects received atorvastatin 10 mg daily and ABT335 135 mg daily by mouth for 8 weeks.
1036180|NCT00728910|O1|Outcome|Atorvastatin|Subjects received atorvastatin 10 mg daily by mouth for 4 weeks followed by apo-A1 kinetics
1036181|NCT00728910|E1|Reported Event|Atorvastatin/ABT335/Niaspan|Subjects received atorvastatin 10 mg/day for 4 weeks, followed by addition of ABT335 135 mg/day for a further 8 weeks followed by the addition of Niaspan 2000 mg/day for a further 10 weeks.
1036182|NCT00728884|B1|Baseline|Certain Prevail Implants|Osseotite surfaced implants with internal connection
1036183|NCT00728884|P1|Participant Flow|Certain Prevail Implants|Osseotite surfaced implants with internal connection
1036184|NCT00728884|O1|Outcome|Certain Prevail Implants|Osseotite surfaced implants with internal connection
1036185|NCT00728884|E1|Reported Event|Certain Prevail Implants|Osseotite surfaced implants with internal connection
1036186|NCT00728845|B3|Baseline|Total|Total of all reporting groups
1036187|NCT00728845|B2|Baseline|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
1036188|NCT00728845|B1|Baseline|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
1036189|NCT00728845|P2|Participant Flow|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
1036190|NCT00728845|P1|Participant Flow|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
1036191|NCT00728845|O2|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
1036192|NCT00728845|O1|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
1036193|NCT00728845|O2|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
1036194|NCT00728845|O1|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
1036195|NCT00728845|O2|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
1036196|NCT00728845|O1|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
1036197|NCT00728845|O2|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
1036198|NCT00728845|O1|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
1036199|NCT00728845|O2|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
1036200|NCT00728845|O1|Outcome|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
1036201|NCT00728845|E2|Reported Event|Hydroxychloroquine, Carboplatin, Paclitaxel|Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
1036202|NCT00728845|E1|Reported Event|Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab|Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
1036203|NCT00728754|B3|Baseline|Total|Total of all reporting groups
1036204|NCT00728754|B2|Baseline|Osseotite Certain Implant|Patients with dental implant with internal connection and without the lateralized expanded platform design
1036205|NCT00728754|B1|Baseline|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
1036206|NCT00728754|P2|Participant Flow|Osseotite Certain Implant|Patients with dental implant with internal connection and without the lateralized expanded platform design
1049606|NCT00697515|O2|Outcome|Placebo|Placebo is administered once-daily
1036207|NCT00728754|P1|Participant Flow|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
1036208|NCT00728754|O2|Outcome|Osseotite Certain Implant|Patients with dental implant with internal connection and without the lateralized expanded platform design
1036209|NCT00728754|O1|Outcome|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
1036210|NCT00728754|E2|Reported Event|Osseotite Certain Implant|Patients with dental implant with internal connection and without the lateralized expanded platform design
1036211|NCT00728754|E1|Reported Event|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
1036212|NCT00728728|B3|Baseline|Total|Total of all reporting groups
1036213|NCT00728728|B2|Baseline|Arm 2: Placebo|Placebo control group
1036214|NCT00728728|B1|Baseline|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
1036215|NCT00728728|P2|Participant Flow|Arm 2: Placebo|Placebo control group
1036216|NCT00728728|P1|Participant Flow|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
1036217|NCT00728728|O2|Outcome|Arm 2: Placebo|Placebo control group
1036218|NCT00728728|O1|Outcome|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
1036219|NCT00728728|O2|Outcome|Arm 2: Placebo|Placebo control group
1036220|NCT00728728|O1|Outcome|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
1036221|NCT00728728|O2|Outcome|Arm 2: Placebo|Placebo control group
1036222|NCT00728728|O1|Outcome|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
1036223|NCT00728728|O2|Outcome|Arm 2: Placebo|Placebo: Placebo
1036224|NCT00728728|O1|Outcome|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
1036225|NCT00728728|O2|Outcome|Arm 2: Placebo|Placebo control group
1036226|NCT00728728|O1|Outcome|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
1036227|NCT00728728|O2|Outcome|Arm 2: Placebo|Placebo control group
1036228|NCT00728728|O1|Outcome|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
1036229|NCT00728728|O2|Outcome|Arm 2: Placebo|Placebo control group
1036230|NCT00728728|O1|Outcome|Arm 1: Pregnenolone|Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
1036231|NCT00728728|E2|Reported Event|Arm 2: Placebo|"Placebo~Placebo: Placebo"
1036232|NCT00728728|E1|Reported Event|Arm 1: Pregnenolone|"Pregnenolone~Dietary Supplement: Pregnenolone: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial."
1036233|NCT00726986|B1|Baseline|Sorafenib, Cisplatin, and Etoposide|Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
1036234|NCT00726986|P1|Participant Flow|Sorafenib, Cisplatin, and Etoposide|Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
1036235|NCT00726986|O1|Outcome|Sorafenib, Cisplatin, and Etoposide|Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
1036236|NCT00726986|O1|Outcome|Sorafenib, Cisplatin, and Etoposide|Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
1036237|NCT00726986|O1|Outcome|Sorafenib, Cisplatin, and Etoposide|Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
1036238|NCT00726986|O1|Outcome|Sorafenib, Cisplatin, and Etoposide|Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
1036239|NCT00726986|E1|Reported Event|Sorafenib, Cisplatin, and Etoposide|Sorafenib, Cisplatin, and Etoposide for 4 cycles (months) during maintenance phase. If no disease progression continue with sorafenib for a maximum of 12 months.
1036240|NCT00726895|B1|Baseline|Entire Study Population|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received either one Quinine Sulfate 324 mg capsule or two Quinine Sulfate 324 mg capsules following an overnight fast of at least 10 hours.
1036241|NCT00726895|P2|Participant Flow|Quinine Sulfate Capsules 2 x 324 mg Dose Then 1 x 324 mg Dose|All subjects received each of the two study regimens (Treatment A - Quinine Sulfate 1 x 324 mg capsule, Treatment B - Quinine Sulfate 2 x 324 mg capsules) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
1036242|NCT00726895|P1|Participant Flow|Quinine Sulfate Capsules 1 x 324 mg Dose Then 2 x 324 mg Dose|All subjects received each of the two study regimens (Treatment A - Quinine Sulfate 1 x 324 mg capsule, Treatment B - Quinine Sulfate 2 x 324 mg capsules) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
1036243|NCT00726895|O3|Outcome|Treatment B - Quinine Sulfate Capsules (2 x 324 mg Dose)|Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
1051422|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
1036244|NCT00726895|O2|Outcome|Treatment A, Dose Adjusted to 2 x 324 mg|This group was a statistical adjustment only. Treatment A (Quinine Sulfate 1 x 324 mg Capsule) Dose Adjusted to 2 x 324 mg was used to evaluate for dose proportionality.
1036245|NCT00726895|O1|Outcome|Treatment A - Quinine Sulfate Capsules (1 x 324 mg Dose)|Each subject received one capsule of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
1036246|NCT00726895|O3|Outcome|Treatment B - Quinine Sulfate Capsules (2 x 324 mg Dose)|Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
1036247|NCT00726895|O2|Outcome|Treatment A, Dose Adjusted to 2 x 324 mg|This group was a statistical adjustment only. Treatment A (Quinine Sulfate 1 x 324 mg Capsule) Dose Adjusted to 2 x 324 mg was used to evaluate for dose proportionality.
1036248|NCT00726895|O1|Outcome|Treatment A - Quinine Sulfate Capsules (1 x 324 mg Dose)|Each subject received one capsule of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
1036249|NCT00726895|O3|Outcome|Treatment B - Quinine Sulfate Capsules (2 x 324 mg Dose)|Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
1036250|NCT00726895|O2|Outcome|Treatment A, Dose Adjusted to 2 x 324 mg|This group was a statistical adjustment only. Treatment A (Quinine Sulfate 1 x 324 mg Capsule) Dose Adjusted to 2 x 324 mg was used to evaluate for dose proportionality.
1036251|NCT00726895|O1|Outcome|Treatment A - Quinine Sulfate Capsules (1 x 324 mg Dose)|Each subject received one capsule of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
1036252|NCT00726895|E2|Reported Event|Treatment B - Quinine Sulfate Capsules 2 x 324 mg Dose|All subjects received each of the two study regimens (Treatment A - Quinine Sulfate 1 x 324 mg capsule, Treatment B - Quinine Sulfate 2 x 324 mg capsules) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
1036253|NCT00726895|E1|Reported Event|Treatment A - Quinine Sulfate Capsules 1 x 324 mg Dose|All subjects received each of the two study regimens (Treatment A - Quinine Sulfate 1 x 324 mg capsule, Treatment B - Quinine Sulfate 2 x 324 mg capsules) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
1036254|NCT00726882|B1|Baseline|HCV-infected Participants|"Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level or matching placebo in a prior clinical study involving ABT−333.~Participants received no treatment in this follow-up study."
1036255|NCT00726882|P1|Participant Flow|HCV-infected Participants|"Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level or matching placebo in a prior clinical study involving ABT−333.~Participants received no treatment in this follow-up study."
1036256|NCT00726882|O1|Outcome|HCV-infected Participants|"Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level or matching placebo in a prior clinical study involving ABT−333.~Participants received no treatment in this follow-up study."
1036257|NCT00726882|O2|Outcome|Participants From Study M10-351|"Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level in the prior clinical study (NCT00696904/M10-351) involving ABT−333.~Participants received no treatment in this follow-up study."
1036258|NCT00726882|O1|Outcome|Participants From Study M10-380|"Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level in the prior clinical study (NCT00851890/M10-380) involving ABT−333.~Participants received no treatment in this follow-up study."
1036259|NCT00726882|E1|Reported Event|HCV-infected Participants|"Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level or matching placebo in a prior clinical study involving ABT−333.~Participants received no treatment in this follow-up study."
1036260|NCT00726830|B3|Baseline|Total|Total of all reporting groups
1036261|NCT00726830|B2|Baseline|Arm II: Opioid Rotation to Another Long-acting Strong Opioid|Participants currently receiving oxycodone are switched to sustained-release (SR) morphine. Participants currently receiving morphine are switched to SR oxycodone. Participants receive either oral SR morphine or oxycodone 2-3 times daily for 4 weeks.
1036262|NCT00726830|B1|Baseline|Arm I: Opioid Rotation to Oral Methadone|Participants are switched from their current opioid medication (oxycodone or morphine) to methadone. Participants receive oral methadone 2-3 times daily for 4 weeks.
1036263|NCT00726830|P2|Participant Flow|Arm II: Opioid Rotation to Another Long-acting Strong Opioid|Participants currently receiving oxycodone are switched to sustained-release (SR) morphine. Participants currently receiving morphine are switched to SR oxycodone. Participants receive either oral SR morphine or oxycodone 2-3 times daily for 4 weeks.
1036264|NCT00726830|P1|Participant Flow|Arm I: Opioid Rotation to Oral Methadone|Participants are switched from their current opioid medication (oxycodone or morphine) to methadone. Participants receive oral methadone 2-3 times daily for 4 weeks.
1036265|NCT00726830|O2|Outcome|Arm II: Opioid Rotation to Another Long-acting Strong Opioid|Participants currently receiving oxycodone are switched to sustained-release (SR) morphine. Participants currently receiving morphine are switched to SR oxycodone. Participants receive either oral SR morphine or oxycodone 2-3 times daily for 4 weeks.
1036266|NCT00726830|O1|Outcome|Arm I: Opioid Rotation to Oral Methadone|Participants are switched from their current opioid medication (oxycodone or morphine) to methadone. Participants receive oral methadone 2-3 times daily for 4 weeks.
1036267|NCT00726830|E2|Reported Event|Arm II: Opioid Rotation to Another Long-acting Strong Opioid|Participants currently receiving oxycodone are switched to sustained-release (SR) morphine. Participants currently receiving morphine are switched to SR oxycodone. Participants receive either oral SR morphine or oxycodone 2-3 times daily for 4 weeks.
1036268|NCT00726830|E1|Reported Event|Arm I: Opioid Rotation to Oral Methadone|Participants are switched from their current opioid medication (oxycodone or morphine) to methadone. Participants receive oral methadone 2-3 times daily for 4 weeks.
1036269|NCT00728689|B3|Baseline|Total|Total of all reporting groups
1036270|NCT00728689|B2|Baseline|ST-246 Form V Followed by Form I|Each of six subjects receive a single 400 mg dose (2×200 mg) of ST-246 Form V, followed 10 days later by a single 400 mg dose (2×200 mg) of ST-246 Form I. Both forms of drug are orally administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
1036271|NCT00728689|B1|Baseline|ST-246 Form I Followed by Form V|Each of six subjects receive a single 400 mg dose (2×200 mg) of ST-246 Form I, followed 10 days later by a single 400 mg dose (2×200 mg) of ST-246 Form V. Both forms of drug are orally administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
1036272|NCT00728689|P2|Participant Flow|ST-246 Form V Followed by Form I|Each of six subjects receive a single 400 mg dose (2×200 mg) of ST-246 Form V, followed 10 days later by a single 400 mg dose (2×200 mg) of ST-246 Form I. Both forms of drug are orally administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
1036273|NCT00728689|P1|Participant Flow|ST-246 Form I Followed by Form V|Each of six subjects receive a single 400 mg dose (2×200 mg) of ST-246 Form I, followed 10 days later by a single 400 mg dose (2×200 mg) of ST-246 Form V. Both forms of drug are orally administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
1036274|NCT00728689|O2|Outcome|ST-246 Form V|ST-246 Form V administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
1036275|NCT00728689|O1|Outcome|ST-246 Form I|ST-246 Form I administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
1036276|NCT00728689|O2|Outcome|ST-246 Form V|ST-246 Form V administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
1036277|NCT00728689|O1|Outcome|ST-246 Form I|ST-246 Form I administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
1036278|NCT00728689|O2|Outcome|ST-246 Form V|ST-246 Form V administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
1036279|NCT00728689|O1|Outcome|ST-246 Form I|ST-246 Form I administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
1036280|NCT00728689|O2|Outcome|ST-246 Form V|ST-246 Form V administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
1036281|NCT00728689|O1|Outcome|ST-246 Form I|ST-246 Form I administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
1036282|NCT00728689|O2|Outcome|ST-246 Form V|ST-246 Form V administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
1036283|NCT00728689|O1|Outcome|ST-246 Form I|ST-246 Form I administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
1036284|NCT00728689|O2|Outcome|ST-246 Form V|ST-246 Form V administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period. Drug was administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
1036285|NCT00728689|O1|Outcome|ST-246 Form I|ST-246 Form I administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period. Drug was administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat.
1036286|NCT00728689|E2|Reported Event|ST-246 Form V|ST-246 Form V administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
1036287|NCT00728689|E1|Reported Event|ST-246 Form I|ST-246 Form I administered as a single 400 mg oral dose (2×200 mg) in either first intervention period or second intervention period.
1036288|NCT00728507|B3|Baseline|Total|Total of all reporting groups
1036289|NCT00728507|B2|Baseline|HRZE|"Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.~Isoniazid, Rifampin, Pyrazinamide, Ethambutol: Administered per standard of care for TB treatment"
1036290|NCT00728507|B1|Baseline|HPZM|"Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.~Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid: Rifapentine:150mg tablets, dose = 300mg for subjects <= 45kg and 450mg for those >45kg by mouth once a day for 8 weeks; Moxifloxacin 400mg tablet by mouth once a day for 8 weeks, Isoniazid and Pyrazinamide per standard of care for TB treatment."
1036291|NCT00728507|P2|Participant Flow|HRZE|"Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.~Isoniazid, Rifampin, Pyrazinamide, Ethambutol: Administered per standard of care for TB treatment"
1036292|NCT00728507|P1|Participant Flow|HPZM|"Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.~Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid: Rifapentine:150mg tablets, dose = 300mg for subjects <= 45kg and 450mg for those >45kg by mouth once a day for 8 weeks; Moxifloxacin 400mg tablet by mouth once a day for 8 weeks, Isoniazid and Pyrazinamide per standard of care for TB treatment."
1036293|NCT00728507|O2|Outcome|HRZE|"Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.~Isoniazid, Rifampin, Pyrazinamide, Ethambutol: Administered per standard of care for TB treatment"
1036294|NCT00728507|O1|Outcome|HPZM|"Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.~Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid: Rifapentine:150mg tablets, dose = 300mg for subjects <= 45kg and 450mg for those >45kg by mouth once a day for 8 weeks; Moxifloxacin 400mg tablet by mouth once a day for 8 weeks, Isoniazid and Pyrazinamide per standard of care for TB treatment."
1036295|NCT00728507|O2|Outcome|HRZE|"Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.~Isoniazid, Rifampin, Pyrazinamide, Ethambutol: Administered per standard of care for TB treatment"
1036296|NCT00728507|O1|Outcome|HPZM|"Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.~Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid: Rifapentine:150mg tablets, dose = 300mg for subjects <= 45kg and 450mg for those >45kg by mouth once a day for 8 weeks; Moxifloxacin 400mg tablet by mouth once a day for 8 weeks, Isoniazid and Pyrazinamide per standard of care for TB treatment."
1036297|NCT00728507|E2|Reported Event|HRZE|"Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.~Isoniazid, Rifampin, Pyrazinamide, Ethambutol: Administered per standard of care for TB treatment"
1036328|NCT00728481|O1|Outcome|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
1036298|NCT00728507|E1|Reported Event|HPZM|"Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.~Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid: Rifapentine:150mg tablets, dose = 300mg for subjects <= 45kg and 450mg for those >45kg by mouth once a day for 8 weeks; Moxifloxacin 400mg tablet by mouth once a day for 8 weeks, Isoniazid and Pyrazinamide per standard of care for TB treatment."
1036299|NCT00728494|B3|Baseline|Total|Total of all reporting groups
1036300|NCT00728494|B2|Baseline|Treatment Alone|PegIntron/Rebetol treatment only
1036301|NCT00728494|B1|Baseline|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
1036302|NCT00728494|P2|Participant Flow|Treatment Alone|PegIntron/Rebetol treatment only
1036303|NCT00728494|P1|Participant Flow|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
1036304|NCT00728494|O2|Outcome|Treatment Alone|PegIntron/Rebetol treatment only
1036305|NCT00728494|O1|Outcome|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
1036306|NCT00728494|O2|Outcome|Treatment Alone|PegIntron/Rebetol treatment only
1036307|NCT00728494|O1|Outcome|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
1036308|NCT00728494|O2|Outcome|Treatment Alone|PegIntron/Rebetol treatment only
1036309|NCT00728494|O1|Outcome|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
1036310|NCT00728494|O2|Outcome|Treatment Alone|PegIntron/Rebetol treatment only
1036311|NCT00728494|O1|Outcome|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
1036312|NCT00728494|O2|Outcome|Treatment Alone|PegIntron/Rebetol treatment only
1036313|NCT00728494|O1|Outcome|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
1036314|NCT00728494|O2|Outcome|Treatment Alone|PegIntron/Rebetol treatment only
1036315|NCT00728494|O1|Outcome|Treatment and Patient Assistance Program|Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
1036316|NCT00728494|E2|Reported Event|Treatment Alone|
1036317|NCT00728494|E1|Reported Event|Treatment and Patient Assistance Program|
1036318|NCT00728481|B3|Baseline|Total|Total of all reporting groups
1036319|NCT00728481|B2|Baseline|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
1036320|NCT00728481|B1|Baseline|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
1036321|NCT00728481|P2|Participant Flow|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
1036322|NCT00728481|P1|Participant Flow|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
1036323|NCT00728481|O2|Outcome|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
1036324|NCT00728481|O1|Outcome|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
1036325|NCT00728481|O2|Outcome|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
1036326|NCT00728481|O1|Outcome|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
1036327|NCT00728481|O2|Outcome|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
1036432|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1036329|NCT00728481|O2|Outcome|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
1036330|NCT00728481|O1|Outcome|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
1036331|NCT00728481|O2|Outcome|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
1036332|NCT00728481|O1|Outcome|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
1036333|NCT00728481|O2|Outcome|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
1036334|NCT00728481|O1|Outcome|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
1036335|NCT00728481|E2|Reported Event|Budesonide|Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
1036336|NCT00728481|E1|Reported Event|Esomeprazole|Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
1036337|NCT00728416|B3|Baseline|Total|Total of all reporting groups
1036338|NCT00728416|B2|Baseline|Placebo Nasal Spray|Matching placebo nasal spray
1036339|NCT00728416|B1|Baseline|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
1036340|NCT00728416|P2|Participant Flow|Placebo Nasal Spray|Matching placebo nasal spray
1036341|NCT00728416|P1|Participant Flow|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
1036342|NCT00728416|O2|Outcome|Placebo Nasal Spray|Matching placebo nasal spray
1036343|NCT00728416|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
1036344|NCT00728416|O2|Outcome|Placebo Nasal Spray|Matching placebo nasal spray
1036345|NCT00728416|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
1036346|NCT00728416|E2|Reported Event|Placebo Nasal Spray|Matching placebo nasal spray
1036347|NCT00728416|E1|Reported Event|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray 200 mcg QD (once per day)
1036348|NCT00728260|B1|Baseline|Menactra Vaccine Recipients|"Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.~Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31–180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.~Menactra vaccine was administered according to routine clinical practice."
1036349|NCT00728260|P1|Participant Flow|Menactra Vaccine Recipients|"Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.~Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31–180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.~Menactra vaccine was administered according to routine clinical practice."
1036350|NCT00728260|O1|Outcome|Menactra Vaccine Recipients|"Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.~Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31–180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.~Menactra vaccine was administered according to routine clinical practice."
1036351|NCT00728260|O1|Outcome|Menactra Vaccine Recipients|"Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.~Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31–180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.~Menactra vaccine was administered according to routine clinical practice."
1036352|NCT00728260|O1|Outcome|Menactra Vaccine Recipients|"Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.~Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31–180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.~Menactra vaccine was administered according to routine clinical practice."
1036382|NCT00728182|O1|Outcome|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
1036383|NCT00728182|E2|Reported Event|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
1036431|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
1036353|NCT00728260|E1|Reported Event|Menactra Vaccine Recipients|"Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.~Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31–180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.~Menactra vaccine was administered according to routine clinical practice."
1036354|NCT00728182|B3|Baseline|Total|Total of all reporting groups
1036355|NCT00728182|B2|Baseline|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
1036356|NCT00728182|B1|Baseline|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
1036357|NCT00728182|P2|Participant Flow|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
1036358|NCT00728182|P1|Participant Flow|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
1036359|NCT00728182|O2|Outcome|2 Placebo - Subjects With Ruptured Aneurysms|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
1036360|NCT00728182|O1|Outcome|1 NA-1 - Subjects With Ruptured Aneurysms|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
1036361|NCT00728182|O2|Outcome|2 Placebo - Subjects With Ruptured Aneurysms|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
1036362|NCT00728182|O1|Outcome|1 NA-1 - Subjects With Ruptured Aneurysms|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
1036363|NCT00728182|O2|Outcome|2 Placebo - Subjects With Ruptured Aneurysms|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
1036364|NCT00728182|O1|Outcome|1 NA-1 - Subjects With Ruptured Aneurysms|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
1036365|NCT00728182|O2|Outcome|2 Placebo - Subjects With Ruptured Aneurysms|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
1036366|NCT00728182|O1|Outcome|1 NA-1 - Subjects With Ruptured Aneurysms|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
1036367|NCT00728182|O2|Outcome|2 Placebo - Subjects With Ruptured Aneurysms|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
1036368|NCT00728182|O1|Outcome|1 NA-1 - Subjects With Ruptured Aneurysms|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
1036369|NCT00728182|O2|Outcome|2 Placebo - Subjects With Ruptured Aneurysms|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
1036370|NCT00728182|O1|Outcome|1 NA-1 - Subjects With Ruptured Aneurysms|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
1036371|NCT00728182|O2|Outcome|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
1036372|NCT00728182|O1|Outcome|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
1036373|NCT00728182|O2|Outcome|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
1036374|NCT00728182|O1|Outcome|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
1036375|NCT00728182|O2|Outcome|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
1036376|NCT00728182|O1|Outcome|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
1036377|NCT00728182|O2|Outcome|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
1036378|NCT00728182|O1|Outcome|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
1036379|NCT00728182|O2|Outcome|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
1036380|NCT00728182|O1|Outcome|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
1036381|NCT00728182|O2|Outcome|2 Placebo|Placebo : single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion
1036428|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
1052581|NCT00687674|O1|Outcome|Sorafenib + Lenalidomide + Dexamethasone|
1036384|NCT00728182|E1|Reported Event|1 NA-1|"20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier.~NA-1 : single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion"
1036385|NCT00728130|B1|Baseline|Surgery|A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients.
1036386|NCT00728130|P1|Participant Flow|Surgery|A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients.
1036387|NCT00728130|O1|Outcome|Surgical Lymph Node Groups|A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients. The number of nodes for each nodal groups will be reported.
1036388|NCT00728130|O1|Outcome|Surgical Lymph Node Groups|A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients. The number of nodes for each nodal groups will be reported.
1036389|NCT00728130|E1|Reported Event|Surgery|A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients.
1036390|NCT00727961|B1|Baseline|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
1036391|NCT00727961|P1|Participant Flow|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
1036392|NCT00727961|O1|Outcome|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
1036393|NCT00727961|O1|Outcome|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
1036394|NCT00727961|O1|Outcome|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
1036395|NCT00727961|O1|Outcome|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
1036396|NCT00727961|O1|Outcome|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
1036397|NCT00727961|O1|Outcome|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
1036398|NCT00727961|O1|Outcome|Caelyx Intravenous|Caelyx Intravenous, 50 mg/m^2, given for 6 cycles
1036399|NCT00727961|E1|Reported Event|Caelyx Intravenous|
1036400|NCT00727909|B1|Baseline|All Study Participants|All study participants received all three hearing aid treatments (TC, RITA, RITE). The sequence of treatments was counter-balanced to prevent an order effect. Each hearing aid treatment lasted two months. Each treatment period was followed by the administration of a series of outcome measures before the next treatment was begun. At the conclusion of the third treatment, in addition to administration of the outcome measures, the participants were asked to rank the three hearing aid treatments in order of preference, and to provide subjective comments regarding the rationale for their rank-ordering.
1036401|NCT00727909|P4|Participant Flow|RITA RITE TC|Participants received the Receiver in the Aid (RITA) hearing aid first, followed by Receiver in the Ear (RITE), followed by Traditional Custom (TC). The length of each hearing aid treatment condition was 2 months.
1036402|NCT00727909|P3|Participant Flow|RITE RITA TC|Participants received the Receiver in the Ear (RITE) hearing aid first, followed by Receiver in the Aid (RITA), followed by Traditional Custom hearing aid (TC). The length of each hearing aid treatment condition was 2 months.
1036403|NCT00727909|P2|Participant Flow|TC RITA RITE|Participants received Traditional Custom hearing aid (TC) first, followed by Receiver in the Aid (RITA), followed by Receiver in the Ear (RITE). The length of each hearing aid treatment condition was 2 months.
1036404|NCT00727909|P1|Participant Flow|TC RITE RITA|Participants received Traditional Custom hearing aid (TC) first, followed by Receiver in the Ear (RITE), followed by Receiver in the Aid (RITA). The length of each hearing aid treatment condition was 2 months.
1036405|NCT00727909|O1|Outcome|All Participants|All participants received all three hearing aid treatments.
1036406|NCT00727909|E1|Reported Event|All Study Participants|All participants received all three hearing aid treatments.
1036407|NCT00727857|B4|Baseline|Total|Total of all reporting groups
1036408|NCT00727857|B3|Baseline|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1036409|NCT00727857|B2|Baseline|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
1036410|NCT00727857|B1|Baseline|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
1036411|NCT00727857|P3|Participant Flow|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1036412|NCT00727857|P2|Participant Flow|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
1036413|NCT00727857|P1|Participant Flow|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
1036414|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1036415|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
1036416|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg/Metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
1036417|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1036418|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
1036419|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
1036420|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1036421|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
1036422|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
1036423|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1036424|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
1036425|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
1036426|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1036427|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
1036433|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
1036434|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
1036435|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1036436|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
1036437|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
1036438|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1036439|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
1036440|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
1036441|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1036442|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
1036443|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
1036444|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1036445|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
1036446|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
1036447|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1036448|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
1036449|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
1036450|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1036451|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
1036452|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
1036453|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1036454|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
1036455|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
1036456|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1036457|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
1036458|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
1036459|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1036460|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
1036461|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
1036462|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1036463|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
1036464|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
1036465|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1036466|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
1036467|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
1036468|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1036469|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
1036470|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
1036471|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1036472|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
1036473|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
1036474|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1036475|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
1036476|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
1036477|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1036478|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
1036479|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
1036480|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1036481|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
1037663|NCT00724594|O1|Outcome|NAC Infants|Infants treated with N-acetylcysteine
1036482|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
1036483|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1036484|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
1036485|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
1036486|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1036487|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
1036488|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
1036489|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1036490|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
1036491|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
1036492|NCT00727857|O3|Outcome|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1036493|NCT00727857|O2|Outcome|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
1036494|NCT00727857|O1|Outcome|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
1036495|NCT00727857|E3|Reported Event|Metformin 850 mg BID|Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
1036496|NCT00727857|E2|Reported Event|Pioglitazone 15 mg BID|Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks
1036497|NCT00727857|E1|Reported Event|Pioglitazone 15 mg/Metformin 850 mg BID|Pioglitazone 15 mg /metformin 850 mg combination tablets, orally, twice daily for up to 24 weeks
1036498|NCT00727844|B3|Baseline|Total|Total of all reporting groups
1036499|NCT00727844|B2|Baseline|Delayed Start Linezolid|Subjects will continue their existing regimen for 2 months after which LZD (600 mg once daily) will be added. After 2 consecutive AFB negative sputum smears (not to exceed 4 months of LZD therapy), subjects will be randomized to continue on 600 mg LZD once daily or to de-escalate to 300 mg once daily. Regardless of the dosage, subjects will remain on LZD treatment for 18 months after sputum culture conversion or until they can no longer tolerate therapy.
1036500|NCT00727844|B1|Baseline|Immediate Start Linezolid|Upon completion of entry criteria, subjects will have LZD (600 mg once daily) added to their regimen. After 2 consecutive AFB negative sputum smears (or at 4 months) subjects will be randomized to continue on 600 mg LZD once daily or to de-escalate to 300 mg once daily. Regardless of the dosage, subjects will remain on LZD treatment for 18 months after sputum culture conversion or until they can no longer tolerate therapy.
1036501|NCT00727844|P4|Participant Flow|2nd Randomization: Linezolid 300 mg Daily|After conversion to negative sputum smears (or receipt of 4 months of therapy), patients underwent a second randomization, stratified according to diabetes mellitus status, either to continue receiving linezolid at a dose of 600 mg per day or to receive a lower dose, 300 mg per day, for an additional 18 months or until therapy was stopped owing to side effects or laboratory abnormalities.
1036502|NCT00727844|P3|Participant Flow|2nd Randomization: Linezolid 600 mg Daily|After conversion to negative sputum smears (or receipt of 4 months of therapy), patients underwent a second randomization, stratified according to diabetes mellitus status, either to continue receiving linezolid at a dose of 600 mg per day or to receive a lower dose, 300 mg per day, for an additional 18 months or until therapy was stopped owing to side effects or laboratory abnormalities.
1036503|NCT00727844|P2|Participant Flow|Initial Randomization: Delayed Start Linezolid|Subjects continued their existing treatment regimen for 2 additional months after which linezolid 600 mg once daily was added.
1036504|NCT00727844|P1|Participant Flow|Initial Randomization: Immediate Start Linezolid|Upon completion of entry criteria, subjects immediately added linezolid 600 mg once daily to their ongoing TB treatment regimen.
1036505|NCT00727844|O2|Outcome|Delayed Start Linezolid|Subjects will continue their existing regimen for 2 months after which LZD (600 mg once daily) will be added. After 2 consecutive AFB negative sputum smears (not to exceed 4 months of LZD therapy), subjects will be randomized to continue on 600 mg LZD once daily or to de-escalate to 300 mg once daily. Regardless of the dosage, subjects will remain on LZD treatment for 18 months after sputum culture conversion or until they can no longer tolerate therapy.
1036506|NCT00727844|O1|Outcome|Immediate Start Linezolid|Upon completion of entry criteria, subjects will have LZD (600 mg once daily) added to their regimen. After 2 consecutive AFB negative sputum smears (or at 4 months) subjects will be randomized to continue on 600 mg LZD once daily or to de-escalate to 300 mg once daily. Regardless of the dosage, subjects will remain on LZD treatment for 18 months after sputum culture conversion or until they can no longer tolerate therapy.
1036507|NCT00727844|E1|Reported Event|Clinically Significant AEs|All clinically significant adverse events, regardless of relationship to linezolid. This includes all SAEs, all AEs grade 3 and above, and all neuropathies grade 2 and above.
1036508|NCT00726752|B1|Baseline|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
1036509|NCT00726752|P1|Participant Flow|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
1036552|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day.
1036510|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
1036511|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
1036512|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
1036513|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
1036514|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
1036515|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
1036516|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
1036517|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
1036518|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
1036519|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
1036520|NCT00726752|O1|Outcome|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
1036521|NCT00726752|E1|Reported Event|AG-013736|Single Dosing: Participants received single AG-013736 5 mg, followed by 7 mg, and subsequently 10 mg. After the single dose at each dose level, participants were monitored for at least 48 hours prior to the next dosing. Multiple Dosing (28-day cycle ): After the monitoring period following the 10 mg single dose, participants received multiple doses of AG-013736 at 5 mg twice daily (BID) at approximately 12 hours apart. The treatment was continued until participants experienced intolerable toxicity or progressive disease.
1036522|NCT00726739|B3|Baseline|Total|Total of all reporting groups
1036523|NCT00726739|B2|Baseline|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on Arm I.
1036524|NCT00726739|B1|Baseline|Arm I and III Crossover Group - LMI + Aldesleukin|"Includes 6 patients who progressed and crossed over from Arm II."
1036551|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
1036525|NCT00726739|P2|Participant Flow|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on Arm I.
1036526|NCT00726739|P1|Participant Flow|Arm I and III Crossover Group - LMI + Aldesleukin|"Patients receive allogeneic large multivalent immunogen melanoma vaccine (LMI) LP2307 intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Includes 6 patients who progressed and crossed over from Arm II."
1036527|NCT00726739|O2|Outcome|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on Arm I.
1036528|NCT00726739|O1|Outcome|Arm I and III Crossover Group - LMI + Aldesleukin|"Patients receive allogeneic large multivalent immunogen melanoma vaccine (LMI) LP2307 intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Includes 6 patients who progressed and crossed over from Arm II. Both KLH and DTH are tests assessing the ability to respond to immune therapy. These are independent tests and there is no bearing of KLH response on DTH response."
1036529|NCT00726739|O2|Outcome|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on Arm I.
1036530|NCT00726739|O1|Outcome|Arm I and III Crossover Group - LMI + Aldesleukin|"Patients receive allogeneic large multivalent immunogen melanoma vaccine (LMI) LP2307 intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Includes 6 patients who progressed and crossed over from Arm II."
1036531|NCT00726739|O2|Outcome|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on Arm I.
1036532|NCT00726739|O1|Outcome|Arm I and III Crossover Group - LMI + Aldesleukin|"Patients receive allogeneic large multivalent immunogen melanoma vaccine (LMI) LP2307 intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Includes 6 patients who progressed and crossed over from Arm II."
1036533|NCT00726739|O2|Outcome|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on Arm I.
1036534|NCT00726739|O1|Outcome|Arm I and III Crossover Group - LMI + Aldesleukin|"Patients receive allogeneic large multivalent immunogen melanoma vaccine (LMI) LP2307 intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Includes 6 patients who progressed and crossed over from Arm II."
1036535|NCT00726739|O2|Outcome|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on Arm I.
1036536|NCT00726739|O1|Outcome|Arm I and III Crossover Group - LMI + Aldesleukin|"Patients receive allogeneic large multivalent immunogen melanoma vaccine (LMI) LP2307 intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Includes 6 patients who progressed and crossed over from Arm II."
1036537|NCT00726739|E2|Reported Event|Arm II (Control) - Aldesleukin|Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on arm I.
1036538|NCT00726739|E1|Reported Event|Arm I and III Crossover Group - LMI + Aldesleukin|"Patients receive allogeneic large multivalent immunogen melanoma vaccine (LMI) LP2307 intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Includes 6 patients who progressed and crossed over from Arm II."
1036539|NCT00726713|B3|Baseline|Total|Total of all reporting groups
1036540|NCT00726713|B2|Baseline|Placebo|Placebo one tablet twice a day
1036541|NCT00726713|B1|Baseline|Metanx|Metanx one tablet twice a day
1036542|NCT00726713|P2|Participant Flow|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
1036543|NCT00726713|P1|Participant Flow|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
1036544|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day.
1036545|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
1036546|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day.
1036547|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
1036548|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
1036549|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
1036550|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day.
1037251|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
1036553|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
1036554|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
1036555|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
1036556|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
1036557|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
1036558|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
1036559|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
1036560|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
1036561|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
1036562|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
1036563|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
1036564|NCT00726713|O2|Outcome|Placebo|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Placebo, one tablet twice a day
1036565|NCT00726713|O1|Outcome|Metanx|Patients aged 25 to 80 years with type 2 diabetes and neuropathy, were given Metanx (L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg (LMF-MC-PLP)) one tablet twice a day.
1036566|NCT00726713|E2|Reported Event|Placebo|Placebo one tablet twice a day
1036567|NCT00726713|E1|Reported Event|Metanx|Metanx one tablet twice a day
1036568|NCT00727740|B3|Baseline|Total|Total of all reporting groups
1036569|NCT00727740|B2|Baseline|2- Placebo|"Placebo suspension in the same volume (20 cc) which is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. The placebo suspension is also flushed with 5 cc of normal saline.~Placebo suspension: A placebo suspension which is made by the Investigational Drug Service (IDS) by adding the appropriate dye coloring to normal saline so that the appearance is identical to the indomethacin suspension. The placebo solution is also instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the placebo suspension, the catheter is flushed with 5 cc of normal saline."
1036570|NCT00727740|B1|Baseline|1- Indomethacin|"Indomethacin liquid suspension 100 mg (25 mg/5ml) which is 20 cc of suspension instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.~Indomethacin: Indomethacin 100 mg liquid suspension (25 mg/5 ml) which is 20 cc of suspension is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline."
1036571|NCT00727740|P2|Participant Flow|2- Placebo|"Placebo suspension in the same volume (20 cc) which is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. The placebo suspension is also flushed with 5 cc of normal saline.~Placebo suspension: A placebo suspension which is made by the Investigational Drug Service (IDS) by adding the appropriate dye coloring to normal saline so that the appearance is identical to the indomethacin suspension. The placebo solution is also instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the placebo suspension, the catheter is flushed with 5 cc of normal saline."
1036572|NCT00727740|P1|Participant Flow|1- Indomethacin|"Indomethacin liquid suspension 100 mg (25 mg/5ml) which is 20 cc of suspension instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.~Indomethacin: Indomethacin 100 mg liquid suspension (25 mg/5 ml) which is 20 cc of suspension is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline."
1036573|NCT00727740|O2|Outcome|2- Placebo|"Placebo suspension in the same volume (20 cc) which is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. The placebo suspension is also flushed with 5 cc of normal saline.~Placebo suspension: A placebo suspension which is made by the Investigational Drug Service (IDS) by adding the appropriate dye coloring to normal saline so that the appearance is identical to the indomethacin suspension. The placebo solution is also instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the placebo suspension, the catheter is flushed with 5 cc of normal saline."
1036574|NCT00727740|O1|Outcome|1- Indomethacin|"Indomethacin liquid suspension 100 mg (25 mg/5ml) which is 20 cc of suspension instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.~Indomethacin: Indomethacin 100 mg liquid suspension (25 mg/5 ml) which is 20 cc of suspension is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline."
1036636|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
1036575|NCT00727740|E2|Reported Event|2- Placebo|"Placebo suspension in the same volume (20 cc) which is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. The placebo suspension is also flushed with 5 cc of normal saline.~Placebo suspension: A placebo suspension which is made by the Investigational Drug Service (IDS) by adding the appropriate dye coloring to normal saline so that the appearance is identical to the indomethacin suspension. The placebo solution is also instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the placebo suspension, the catheter is flushed with 5 cc of normal saline."
1036576|NCT00727740|E1|Reported Event|1- Indomethacin|"Indomethacin liquid suspension 100 mg (25 mg/5ml) which is 20 cc of suspension instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.~Indomethacin: Indomethacin 100 mg liquid suspension (25 mg/5 ml) which is 20 cc of suspension is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline."
1036577|NCT00727714|B1|Baseline|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
1036578|NCT00727714|P1|Participant Flow|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
1036579|NCT00727714|O1|Outcome|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
1036580|NCT00727714|O1|Outcome|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
1036581|NCT00727714|O1|Outcome|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
1036582|NCT00727714|O1|Outcome|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
1036583|NCT00727714|O1|Outcome|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
1036584|NCT00727714|E1|Reported Event|Exposed Workers|95 workers from two cement plants in Norway were included and examined pre and post shift (ohr and 8hr)and again after 24 hours.
1036585|NCT00727649|B3|Baseline|Total|Total of all reporting groups
1036586|NCT00727649|B2|Baseline|L1P2 (Loperamide First, Then Pysllium)|"Fiber (psyllium) powder placebo with loperamide 2mg pill~Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy"
1036587|NCT00727649|B1|Baseline|P1L2 (Psyllium First, Then Loperamide)|"Fiber (psyllium) powder with loperamide placebo first~Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 2 mg placebo daily with weekly dose adjustments for side-effects and/or efficacy"
1036588|NCT00727649|P2|Participant Flow|L1P2 (Loperamide First, Then Pysllium)|"Fiber (psyllium) powder placebo with loperamide 2mg~Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy"
1036589|NCT00727649|P1|Participant Flow|P1L2 (Psyllium First, Then Loperamide)|"Fiber (psyllium) powder with loperamide placebo first~Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy"
1036590|NCT00727649|O2|Outcome|L1P2 (Loperamide First, Then Pysllium)|"Fiber (psyllium) powder placebo with loperamide 2mg~Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy"
1036591|NCT00727649|O1|Outcome|P1L2 (Psyllium First, Then Loperamide)|"Fiber (psyllium) powder with loperamide placebo first~Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy"
1036592|NCT00727649|O2|Outcome|L1P2 (Loperamide First, Then Pysllium)|"Fiber (psyllium) powder placebo with loperamide 2mg~Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy"
1036593|NCT00727649|O1|Outcome|P1L2 (Psyllium First, Then Loperamide)|"Fiber (psyllium) powder with loperamide placebo first~Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy"
1036594|NCT00727649|O2|Outcome|L1P2 (Loperamide First, Then Pysllium)|"Fiber (psyllium) powder placebo with loperamide 2mg~Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy"
1036595|NCT00727649|O1|Outcome|P1L2 (Psyllium First, Then Loperamide)|"Fiber (psyllium) powder with loperamide placebo first~Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy"
1036596|NCT00727649|E4|Reported Event|L1P2 (Psyllium Second); 2nd 4-weeks|"Fiber (psyllium) powder with loperamide placebo first~Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy"
1036597|NCT00727649|E3|Reported Event|P1L2 (Loperamide Second); 2nd 4-weeks|"Fiber (psyllium) powder placebo with loperamide 2mg~Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy"
1036598|NCT00727649|E2|Reported Event|L1P2 (Loperamide First): 1st 4-weeks|"Fiber (psyllium) powder placebo with loperamide 2mg~Psyllium placebo powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose for side-effects and/or efficacy) Loperamide: 2 mg daily with weekly dose adjustments for side-effects and/or efficacy"
1037664|NCT00724594|O1|Outcome|NAC Maternal|Mothers treated with N-acetylcysteine prior to birth
1036599|NCT00727649|E1|Reported Event|P1L2 (Psyllium First); 1st 4-weeks|"Fiber (psyllium) powder with loperamide placebo first~Psyllium powder: 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose) Loperamide placebo: 1 tablet daily with weekly dose adjustments for side-effects and/or efficacy"
1036600|NCT00727636|B3|Baseline|Total|Total of all reporting groups
1036601|NCT00727636|B2|Baseline|Retrospective Cohort|Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
1036602|NCT00727636|B1|Baseline|Prospective Cohort|Received Gardasil as part of study
1036603|NCT00727636|P2|Participant Flow|Retrospective Cohort|Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
1036604|NCT00727636|P1|Participant Flow|Prospective Cohort|Received Gardasil as part of study
1036605|NCT00727636|O2|Outcome|Retrospective Cohort|Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
1036606|NCT00727636|O1|Outcome|Prospective Cohort|Received Gardasil as part of study
1036607|NCT00727636|O2|Outcome|Retrospective Cohort|Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
1036608|NCT00727636|O1|Outcome|Prospective Cohort|Received Gardasil as part of study
1036609|NCT00727636|O2|Outcome|Retrospective Cohort|Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
1036610|NCT00727636|O1|Outcome|Prospective Cohort|Received Gardasil as part of study
1036611|NCT00727636|O2|Outcome|Retrospective Cohort|Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
1036612|NCT00727636|O1|Outcome|Prospective Cohort|Received Gardasil as part of study
1036613|NCT00727636|E2|Reported Event|Retrospective Cohort|Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
1036614|NCT00727636|E1|Reported Event|Prospective Cohort|Received Gardasil as part of study
1036615|NCT00727597|B3|Baseline|Total|Total of all reporting groups
1036616|NCT00727597|B2|Baseline|QD Regimen of Sustiva|QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
1036617|NCT00727597|B1|Baseline|Once Daily (QD) Regimen of Lexiva|Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).
1036618|NCT00727597|P2|Participant Flow|QD Regimen of Sustiva|QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
1036619|NCT00727597|P1|Participant Flow|Once Daily (QD) Regimen of Lexiva|Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).
1036620|NCT00727597|O2|Outcome|QD Regimen of Sustiva|QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
1036621|NCT00727597|O1|Outcome|Once Daily (QD) Regimen of Lexiva|Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).
1036622|NCT00727597|O2|Outcome|QD Regimen of Sustiva|QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
1036623|NCT00727597|O1|Outcome|Once Daily (QD) Regimen of Lexiva|Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).
1036624|NCT00727597|E2|Reported Event|QD Regimen of Sustiva|QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
1036625|NCT00727597|E1|Reported Event|Once Daily (QD) Regimen of Lexiva|Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).
1036626|NCT00727571|B5|Baseline|Total|Total of all reporting groups
1036627|NCT00727571|B4|Baseline|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
1036628|NCT00727571|B3|Baseline|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
1036629|NCT00727571|B2|Baseline|No CKD or Anemia|CKD is based on estimated GFR, calculated by the MDRD method, of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
1036630|NCT00727571|B1|Baseline|No CKD, But Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
1036631|NCT00727571|P4|Participant Flow|No CKD, But Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria. Participants completed the study at Week 2 and completed an anemia work-up; data contributed to prevalence estimates.
1036632|NCT00727571|P3|Participant Flow|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria. Participants were observed for 26 weeks and completed mobility and physical performance assessments.
1036633|NCT00727571|P2|Participant Flow|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria. Participants were observed for 26 weeks and completed an anemia work-up, and mobility and physical performance assessments.
1036634|NCT00727571|P1|Participant Flow|No CKD or Anemia|Chronic kidney disease (CKD) is based on an estimated Glomerular Filtration Rate (GFR), calculated by the Modification of Diet in Renal Disease (MDRD) method, of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per World Health Organization (WHO) criteria. Participants completed the study after Week 1; data contributed to prevalence estimates.
1036635|NCT00727571|O2|Outcome|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
1036678|NCT00727558|E1|Reported Event|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
1036637|NCT00727571|O2|Outcome|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
1036638|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
1036639|NCT00727571|O2|Outcome|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
1036640|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
1036641|NCT00727571|O2|Outcome|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
1036642|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
1036643|NCT00727571|O2|Outcome|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
1036644|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
1036645|NCT00727571|O2|Outcome|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
1036646|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
1036647|NCT00727571|O2|Outcome|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
1036648|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
1036649|NCT00727571|O2|Outcome|No CKD But Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
1036650|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
1036651|NCT00727571|O1|Outcome|All Enrolled Participants|
1036652|NCT00727571|O2|Outcome|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
1036653|NCT00727571|O1|Outcome|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
1036654|NCT00727571|E4|Reported Event|No CKD, But Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria. Participants completed the study at Week 2 and completed an anemia work-up; data contributed to prevalence estimates.
1036655|NCT00727571|E3|Reported Event|CKD With no Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
1036656|NCT00727571|E2|Reported Event|CKD With Anemia|CKD is based on estimated GFR calculated by the MDRD method of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
1036657|NCT00727571|E1|Reported Event|No CKD or Anemia|CKD is based on estimated GFR, calculated by the MDRD method, of < 60 mL/min/1.73m^2. Anemia is defined as Hemogloblin <12 g/dL in women, < 13 g/dL in men per WHO criteria.
1036658|NCT00727558|B3|Baseline|Total|Total of all reporting groups
1036659|NCT00727558|B2|Baseline|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
1036660|NCT00727558|B1|Baseline|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
1036661|NCT00727558|P2|Participant Flow|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
1036662|NCT00727558|P1|Participant Flow|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
1036663|NCT00727558|O2|Outcome|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
1036664|NCT00727558|O1|Outcome|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
1036665|NCT00727558|O2|Outcome|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
1036666|NCT00727558|O1|Outcome|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
1036667|NCT00727558|O2|Outcome|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
1036668|NCT00727558|O1|Outcome|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
1036669|NCT00727558|O2|Outcome|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
1036670|NCT00727558|O1|Outcome|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
1036671|NCT00727558|O2|Outcome|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
1036672|NCT00727558|O1|Outcome|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
1036673|NCT00727558|O2|Outcome|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
1036674|NCT00727558|O1|Outcome|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
1036675|NCT00727558|O2|Outcome|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
1036676|NCT00727558|O1|Outcome|Narafilcon A|soft contact lens worn as a daily disposable modality for one week
1036677|NCT00727558|E2|Reported Event|Nelfilcon A|soft contact lens worn as a daily disposable modality for one week
1036679|NCT00727506|B7|Baseline|Total|Total of all reporting groups
1036680|NCT00727506|B6|Baseline|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
1036681|NCT00727506|B5|Baseline|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
1036682|NCT00727506|B4|Baseline|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
1036683|NCT00727506|B3|Baseline|Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
1036684|NCT00727506|B2|Baseline|Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
1036685|NCT00727506|B1|Baseline|Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 20mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
1036686|NCT00727506|P6|Participant Flow|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
1036687|NCT00727506|P5|Participant Flow|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
1036688|NCT00727506|P4|Participant Flow|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
1036689|NCT00727506|P3|Participant Flow|Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
1036690|NCT00727506|P2|Participant Flow|Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
1036691|NCT00727506|P1|Participant Flow|Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 20mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
1036692|NCT00727506|O3|Outcome|Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
1036693|NCT00727506|O2|Outcome|Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
1036694|NCT00727506|O1|Outcome|Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 20mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
1036695|NCT00727506|O3|Outcome|Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
1036696|NCT00727506|O2|Outcome|Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
1036697|NCT00727506|O1|Outcome|Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 20mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
1036698|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
1036699|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
1036700|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
1036701|NCT00727506|O3|Outcome|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
1036702|NCT00727506|O2|Outcome|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
1036703|NCT00727506|O1|Outcome|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
1036704|NCT00727506|E6|Reported Event|Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
1036705|NCT00727506|E5|Reported Event|Phase II - Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.) - Phase II part
1036706|NCT00727506|E4|Reported Event|Phase II - Temozolomide 75mg/m^2|Patients receiving Temozolomide monotherapy 75 mg/m^2 for 21 days followed by 7 days off - Phase II part
1036707|NCT00727506|E3|Reported Event|Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 50mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
1036708|NCT00727506|E2|Reported Event|Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 40mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
1036709|NCT00727506|E1|Reported Event|Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2|Patients receiving Afatinib 20mg once daily (q.d.) plus Temozolomide 75 mg/m^2 for 21 days followed by 7 days off - Phase I part
1036710|NCT00727402|B1|Baseline|Observational|healthy patients fit into lotrafilcon A contact lenses for continuous wear
1036711|NCT00727402|P1|Participant Flow|Observational|healthy patients fit into lotrafilcon A contact lenses for continuous wear
1036712|NCT00727402|O1|Outcome|Observational|healthy patients fit into lotrafilcon A contact lenses for continuous wear
1036713|NCT00727402|E1|Reported Event|Observational|healthy patients fit into lotrafilcon A contact lenses for continuous wear
1036714|NCT00727337|B5|Baseline|Total|Total of all reporting groups
1036715|NCT00727337|B4|Baseline|LACE-DVD|"DVD-based auditory training~Auditory Training with DVD: DVD based Auditory Training"
1036716|NCT00727337|B3|Baseline|CONTROL|"No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids~Usual care: No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids"
1036818|NCT00727090|O2|Outcome|Usual Medical Care|Usual care by the attending physician staff
1036717|NCT00727337|B2|Baseline|PLACEBO-DIRECTED LISTENING|"Directed listening to books on CD~Directed listening: Subjects will be asked to listen to books on tape for 20 minutes a day and answer questions as they go along"
1036718|NCT00727337|B1|Baseline|LACE-COMPUTER|"Computer-based auditory training~LACE: Computerized Auditory Training"
1036719|NCT00727337|P4|Participant Flow|LACE-DVD|"DVD-based auditory training~Auditory Training with DVD: DVD based Auditory Training"
1036720|NCT00727337|P3|Participant Flow|CONTROL|"No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids~Usual care: No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids"
1036721|NCT00727337|P2|Participant Flow|PLACEBO-DIRECTED LISTENING|"Directed listening to books on CD~Directed listening: Subjects will be asked to listen to books on tape for 20 minutes a day and answer questions as they go along"
1036722|NCT00727337|P1|Participant Flow|LACE - COMPUTER|"Computer-based auditory training~LACE: Computerized Auditory Training"
1036723|NCT00727337|O4|Outcome|LACE-DVD|"DVD-based auditory training~Auditory Training with DVD: DVD based Auditory Training"
1036724|NCT00727337|O3|Outcome|CONTROL|"No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids~Usual care: No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids"
1036725|NCT00727337|O2|Outcome|PLACEBO-DIRECTED LISTENING|"Directed listening to books on CD~Directed listening: Subjects will be asked to listen to books on tape for 20 minutes a day and answer questions as they go along"
1036726|NCT00727337|O1|Outcome|LACE-COMPUTER|"Computer-based auditory training~LACE: Computerized Auditory Training"
1036727|NCT00727337|E4|Reported Event|LACE-DVD|"DVD-based auditory training~Auditory Training with DVD: DVD based Auditory Training"
1036728|NCT00727337|E3|Reported Event|CONTROL|"No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids~Usual care: No specialized treatment will be provided in addition to standard of care audiology treatment provided with the provision of hearing aids"
1036729|NCT00727337|E2|Reported Event|PLACEBO-DIRECTED LISTENING|"Directed listening to books on CD~Directed listening: Subjects will be asked to listen to books on tape for 20 minutes a day and answer questions as they go along"
1036730|NCT00727337|E1|Reported Event|LACE-COMPUTER|"Computer-based auditory training~LACE: Computerized Auditory Training"
1036731|NCT00727311|B1|Baseline|PegIntron + Rebetol|"Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.~Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling."
1036732|NCT00727311|P1|Participant Flow|PegIntron + Rebetol|"Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.~Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling."
1036733|NCT00727311|O1|Outcome|PegIntron + Rebetol|"Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.~Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling."
1036734|NCT00727311|O1|Outcome|PegIntron + Rebetol|"Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.~Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling."
1036735|NCT00727311|O1|Outcome|PegIntron + Rebetol|"Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.~Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling."
1036736|NCT00727311|O1|Outcome|PegIntron + Rebetol|"Participants with chronic hepatitis C, who are either treatment-naïve or previously relapsed after receiving interferon monotherapy. PegIntron was administered at a dose 1.5 μg/kg/week, according to the Summary of Product Characteristics (SPC) and approved European labeling.~Rebetol was administered at a dose of 800-1200 mg/day (on a weight-basis) according to the SPC and approved European labeling."
1036737|NCT00727311|E1|Reported Event|All Participants|
1036738|NCT00727298|B1|Baseline|Infliximab|Infliximab administered at a dose of 3-10 mg/kg administered at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
1036739|NCT00727298|P1|Participant Flow|Infliximab|Infliximab administered at a dose of 3-10 mg/kg administered at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
1036740|NCT00727298|O1|Outcome|Infliximab 3-10 mg/kg|Infliximab administered at a dose of 3-10 mg/kg at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
1036741|NCT00727298|O1|Outcome|Infliximab 3-10 mg/kg|Infliximab administered at a dose of 3-10 mg/kg at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
1036742|NCT00727298|O1|Outcome|Infliximab 3-10 mg/kg|Infliximab administered at a dose of 3-10 mg/kg at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
1036743|NCT00727298|E1|Reported Event|Infliximab|Infliximab administered at a dose of 3-10 mg/kg administered at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
1036819|NCT00727090|O1|Outcome|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
1036820|NCT00727090|O2|Outcome|Usual Medical Care|Usual care by the attending physician staff
1037665|NCT00724594|O3|Outcome|NAC Term Infants|Term infants treated with N-acetylcysteine
1036744|NCT00727272|B1|Baseline|Entire Study Population|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under Fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
1036745|NCT00727272|P3|Participant Flow|Treatment Sequence CAB|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
1036746|NCT00727272|P2|Participant Flow|Treatment Sequence BCA|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
1036747|NCT00727272|P1|Participant Flow|Treatment Sequence ABC|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
1036748|NCT00727272|O4|Outcome|Treatment C - Quinine Sulfate 324 mg Caps, Fed Conditions|Each subject received one capsule of Quinine Sulfate 324 mg thirty minutes after the initiation of a standardized, high-fat breakfast following an overnight fast.
1036749|NCT00727272|O3|Outcome|Treatment B- Quinine Sulphate 300 mg Tabs, Fasting Conditions|Each subject received one tablet of Quinine Sulphate 300 mg after an overnight fast of at least 10 hours.
1036750|NCT00727272|O2|Outcome|Treatment A, Dose Adjusted to 300 mg|This group was a statistical adjustment only. Treatment A (Quinine Sulfate 1 x 324 mg Capsule) Dose Adjusted to 300 mg was used to evaluate for dose proportionality.
1036751|NCT00727272|O1|Outcome|Treatment A - Quinine Sulfate 324 mg Caps, Fasting Conditions|Each subject received one capsule of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
1036752|NCT00727272|O4|Outcome|Treatment C - Quinine Sulfate 324 mg Caps, Fed Conditions|Each subject received one capsule of Quinine Sulfate 324 mg 30 minutes after the initiation of a standardized, high-fat breakfast following an overnight fast.
1036753|NCT00727272|O3|Outcome|Treatment B- Quinine Sulphate 300 mg Tabs, Fasting Conditions|Each subject received one tablet of Quinine Sulphate 300 mg after an overnight fast of at least 10 hours.
1036754|NCT00727272|O2|Outcome|Treatment A, Dose Adjusted to 300 mg|This group was a statistical adjustment only. Treatment A (Quinine Sulfate 1 x 324 mg Capsule) Dose Adjusted to 300 mg was used to evaluate for dose proportionality.
1036755|NCT00727272|O1|Outcome|Treatment A - Quinine Sulfate 324 mg Caps, Fasting Conditions|Each subject received one capsule of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
1036756|NCT00727272|O4|Outcome|Treatment C - Quinine Sulfate 324 mg Caps, Fed Conditions|Each subject received one capsule of Quinine Sulfate 324 mg thirty minutes after the initiation of a standardized, high-fat breakfast following an overnight fast.
1036757|NCT00727272|O3|Outcome|Treatment B- Quinine Sulphate 300 mg Tabs, Fasting Conditions|Each subject received one tablet of Quinine Sulphate 300 mg after an overnight fast of at least 10 hours.
1036758|NCT00727272|O2|Outcome|Treatment A, Dose Adjusted to 300 mg|This group was a statistical adjustment only. Treatment A (Quinine Sulfate 1 x 324 mg Capsule) Dose Adjusted to 300 mg was used to evaluate for dose proportionality.
1036759|NCT00727272|O1|Outcome|Treatment A - Quinine Sulfate 324 mg Caps, Fasting Conditions|Each subject received one capsule of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
1036760|NCT00727272|E3|Reported Event|Treatment C - Quinine Sulfate Capsules 324 mg - Fed|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
1036761|NCT00727272|E2|Reported Event|Treatment B - Quinine Sulphate Tablets 300 mg - Fasting|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
1036762|NCT00727272|E1|Reported Event|Treatment A - Quinine Sulfate Capsules 324 mg - Fasting|All subjects received each of the three study regimens (Treatment A - Quinine Sulfate Capsules 324 mg under fasting conditions, Treatment B - Quinine Sulphate Tablets 300 mg under fasting conditions and Treatment C - Quinine Sulfate Capsules 324 mg under fed conditions) in a randomly assigned sequence of dosing periods, each followed by a washout period of 7 days.
1036763|NCT00727259|B1|Baseline|Patients With Chronic Hepatitis C|Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol. Results presented concern only participants with all questionnaires returned (940).
1036764|NCT00727259|P1|Participant Flow|Patients With Chronic Hepatitis C|Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.
1036765|NCT00727259|O2|Outcome|After 3 Months of Treatment|Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.
1036766|NCT00727259|O1|Outcome|After 1 Month of Treatment|Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.
1036767|NCT00727259|E1|Reported Event|Patients With Chronic Hepatitis C|Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.
1036768|NCT00727220|B3|Baseline|Total|Total of all reporting groups
1036769|NCT00727220|B2|Baseline|Insulin Injections|
1036770|NCT00727220|B1|Baseline|Insulin Pump Therapy|
1036771|NCT00727220|P2|Participant Flow|Insulin Injections|
1036772|NCT00727220|P1|Participant Flow|Insulin Pump Therapy|
1036773|NCT00727220|O2|Outcome|Insulin Injections|
1036774|NCT00727220|O1|Outcome|Insulin Pump Therapy|
1036775|NCT00727220|E2|Reported Event|Insulin Injections|
1036776|NCT00727220|E1|Reported Event|Insulin Pump Therapy|
1037666|NCT00724594|O2|Outcome|NAC Preterm Infants|Preterm infants treated with N-acetylcysteine
1036777|NCT00727194|B1|Baseline|Overall Study|"Eculizumab:~Eculizumab [600 mg IV weekly (4 doses) followed by 900 mg IV every other week (7 doses)].~Period 1: patients received eculizumab for 16 weeks; Period 2: wash-out period for 5 weeks (the cross-over treatment period). Patients then received placebo for 16 weeks.~Placebo:~Matching placebo [IV weekly (4 doses) followed by IV every other week (7 doses)] Period 1: patients received placebo for 16 weeks; Period 2: wash-out period for 5 weeks (the cross-over treatment period). Patients then received eculizumab for 16 weeks."
1036778|NCT00727194|P3|Participant Flow|Not Randomized/Screen Failures|Not randomized; not treatment cohort
1036779|NCT00727194|P2|Participant Flow|Placebo to Eculizumab Sequence|"Placebo: matching placebo IV weekly (4 doses) followed by IV every other week (7 doses).~Eculizumab: eculizumab 600 mg IV weekly (4 doses) followed by 900 mg IV every other week (7 doses).~Period 1: patients received placebo for 16 weeks.~Wash-out period for 5 weeks.~Period 2 (cross-over treatment period): patients received eculizumab for 16 weeks."
1036780|NCT00727194|P1|Participant Flow|Eculizumab to Placebo Sequence|"Eculizumab: eculizumab 600 mg IV weekly (4 doses) followed by 900 mg IV every other week (7 doses)~Placebo: matching placebo IV weekly (4 doses) followed by IV every other week (7 doses)~Period 1: patients received eculizumab for 16 weeks.~Wash-out period for 5 weeks.~Period 2 (cross-over treatment period): patients received placebo for 16 weeks."
1036781|NCT00727194|O2|Outcome|Placebo|All patients who received study treatment(s)
1036782|NCT00727194|O1|Outcome|Eculizumab|All patients who received study treatment(s)
1036783|NCT00727194|O2|Outcome|Placebo|All patients who received study treatment(s)
1036784|NCT00727194|O1|Outcome|Eculizumab|All patients who received study treatment(s)
1036785|NCT00727194|O4|Outcome|Placebo Both Periods|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
1036786|NCT00727194|O3|Outcome|Eculizumab Both Periods|"eculizumab~eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
1036787|NCT00727194|O2|Outcome|Placebo Period 1|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
1036788|NCT00727194|O1|Outcome|Eculizumab Period 1|"eculizumab~eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
1036789|NCT00727194|O4|Outcome|Placebo Both Periods|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
1036790|NCT00727194|O3|Outcome|Eculizumab Both Periods|"eculizumab~eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
1036791|NCT00727194|O2|Outcome|Placebo Period 1|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
1036792|NCT00727194|O1|Outcome|Eculizumab Period 1|"eculizumab~eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
1036793|NCT00727194|O4|Outcome|Placebo Both Periods|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
1036794|NCT00727194|O3|Outcome|Eculizumab Both Periods|"Eculizumab~Eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
1036795|NCT00727194|O2|Outcome|Placebo Period 1|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
1036796|NCT00727194|O1|Outcome|Eculizumab Period 1|"Eculizumab~Eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
1036797|NCT00727194|O4|Outcome|Placebo Both Periods|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
1036798|NCT00727194|O3|Outcome|Eculizumab Both Periods|"Eculizumab~Eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
1036799|NCT00727194|O2|Outcome|Placebo Period 1|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
1036800|NCT00727194|O1|Outcome|Eculizumab Period 1|"Eculizumab~Eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
1036801|NCT00727194|O4|Outcome|Placebo Period 2|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
1036802|NCT00727194|O3|Outcome|Eculizumab Period 2|"eculizumab~eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
1036803|NCT00727194|O2|Outcome|Placebo Period 1|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
1036804|NCT00727194|O1|Outcome|Eculizumab Period 1|"eculizumab~eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
1036805|NCT00727194|O4|Outcome|Placebo Both Periods|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
1036806|NCT00727194|O3|Outcome|Eculizumab Both Periods|"eculizumab~eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
1036807|NCT00727194|O2|Outcome|Placebo Period 1|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
1036808|NCT00727194|O1|Outcome|Eculizumab Period 1|"eculizumab~eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
1036809|NCT00727194|O2|Outcome|Placebo Period 1|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses"
1036810|NCT00727194|O1|Outcome|Eculizumab Period 1|"eculizumab~eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses"
1036811|NCT00727194|E2|Reported Event|Eculizumab|"Eculizumab~Eculizumab: eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses~Events that occurred during the Washout Period were attributed to treatment assignment during Treatment Period 1."
1036812|NCT00727194|E1|Reported Event|Placebo|"Placebo~Placebo: Placebo IV weekly for 4 doses then every two weeks for 7 doses~Events that occurred during the Washout Period were attributed to treatment assignment during Treatment Period 1."
1036813|NCT00727090|B3|Baseline|Total|Total of all reporting groups
1036814|NCT00727090|B2|Baseline|Usual Medical Care|Usual care by the attending physician staff
1036815|NCT00727090|B1|Baseline|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
1036816|NCT00727090|P2|Participant Flow|Usual Medical Care|Usual care by the attending physician staff
1036817|NCT00727090|P1|Participant Flow|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
1036821|NCT00727090|O1|Outcome|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
1036822|NCT00727090|O2|Outcome|Usual Medical Care|Usual care by the attending physician staff
1036823|NCT00727090|O1|Outcome|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
1036824|NCT00727090|O2|Outcome|Usual Medical Care|Usual care by the attending physician staff
1036825|NCT00727090|O1|Outcome|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
1036826|NCT00727090|O2|Outcome|Usual Medical Care|Usual care by the attending physician staff
1036827|NCT00727090|O1|Outcome|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
1036828|NCT00727090|O2|Outcome|Usual Medical Care|Usual care by the attending physician staff
1036829|NCT00727090|O1|Outcome|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
1036830|NCT00727090|E2|Reported Event|Usual Medical Care|Usual care by the attending physician staff
1036831|NCT00727090|E1|Reported Event|Treatment: Conivaptan|Conivaptan per package labeling, 20 mg IV bolus followed by 20 mg IV infusion over 24 hours
1036832|NCT00727064|B3|Baseline|Total|Total of all reporting groups
1036833|NCT00727064|B2|Baseline|Sequence Group B|Day 1: single 75mg oral dose of Venlafaxine Extended Release (VEN ER) in a fasting state. Days 1-6: 120 hours of PK sampling. Days 7-10: Wash out period. Day 11: single 50mg oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) in a fasting state. Day 11-16: 120 hours of PK sampling.
1036834|NCT00727064|B1|Baseline|Sequence Group A|Day 1: single 50mg oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) in a fasting state. Days 1-6: 120 hours of PK sampling. Days 7-10: Wash out period. Day 11: single 75mg oral dose of Venlafaxine ER (VEN ER) in a fasting state. Day 11-16: 120 hours of PK sampling.
1036835|NCT00727064|P2|Participant Flow|Sequence Group B|Day 1: single 75mg oral dose of Venlafaxine Extended Release (VEN ER) in a fasting state. Days 1-6: 120 hours of PK sampling. Days 7-10: Wash out period. Day 11: single 50mg oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) in a fasting state. Day 11-16: 120 hours of PK sampling.
1036836|NCT00727064|P1|Participant Flow|Sequence Group A|Day 1: single 50mg oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) in a fasting state. Days 1-6: 120 hours of PK sampling. Days 7-10: Wash out period. Day 11: single 75mg oral dose of Venlafaxine ER (VEN ER) in a fasting state. Day 11-16: 120 hours of PK sampling.
1036837|NCT00727064|O2|Outcome|Poor Metabolizers (PM)|Identified as PM from CYP2D6 testing at screening
1036838|NCT00727064|O1|Outcome|Extensive Metabolizers (EM)|Identified as EM from CYP2D6 testing at screening
1036839|NCT00727064|O2|Outcome|Poor Metabolizers (PM)|Identified as PM from CYP2D6 testing at screening
1036840|NCT00727064|O1|Outcome|Extensive Metabolizers (EM)|Identified as EM from CYP2D6 testing at screening
1036841|NCT00727064|O2|Outcome|Poor Metabolizers (PM)|Identified as PM from CYP2D6 testing at screening
1036842|NCT00727064|O1|Outcome|Extensive Metabolizers (EM)|Identified as EM from CYP2D6 testing at screening
1036843|NCT00727064|O2|Outcome|Poor Metabolizers (PM)|Identified as PM from CYP2D6 testing at screening
1036844|NCT00727064|O1|Outcome|Extensive Metabolizers (EM)|Identified as EM from CYP2D6 testing at screening
1036845|NCT00727064|O2|Outcome|Poor Metabolizers (PM)|Identified as PM from CYP2D6 testing at screening
1036846|NCT00727064|O1|Outcome|Extensive Metabolizers (EM)|Identified as EM from CYP2D6 testing at screening
1036847|NCT00727064|O2|Outcome|Poor Metabolizers (PM)|Identified as PM from CYP2D6 testing at screening
1036848|NCT00727064|O1|Outcome|Extensive Metabolizers (EM)|Identified as EM from CYP2D6 testing at screening
1036849|NCT00727064|E2|Reported Event|Venlafaxine Extended Release (VEN ER)|SAE or AE reported on VEN ER regardless of which arm or period of trial.
1036850|NCT00727064|E1|Reported Event|Desvenlafaxine Succinate Sustained-Release (DVS SR)|SAE or AE reported on DVS SR regardless of which arm or period of trial.
1036851|NCT00727025|B1|Baseline|All Participants|Participants randomized to have one segment of wounds closed with steri-strip device and the other wound segment closed with traditional suture closure.
1036852|NCT00727025|P1|Participant Flow|All Participants|Participants randomized to have one segment of wounds closed with steri-strip device and the other wound segment closed with traditional suture closure.
1036853|NCT00727025|O2|Outcome|Suture Closure|
1036854|NCT00727025|O1|Outcome|Steri-strip Closure|
1036855|NCT00727025|O2|Outcome|Wounds Closed With Suture|wound segments closed with traditional suture
1036856|NCT00727025|O1|Outcome|Wounds Closed With Device|segment of wounds closed with steri-strip device
1036857|NCT00727025|O2|Outcome|Wounds Closed With Suture|wound segments closed with traditional suture
1036858|NCT00727025|O1|Outcome|Wounds Closed With Device|segment of wounds closed with steri-strip device
1036859|NCT00727025|E2|Reported Event|Wounds Closed With Suture|wound segments closed with traditional suture
1036860|NCT00727025|E1|Reported Event|Wounds Closed With Device|segment of wounds closed with steri-strip device
1036861|NCT00726999|B3|Baseline|Total|Total of all reporting groups
1036862|NCT00726999|B2|Baseline|Placebo/Morphine|Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed.
1036863|NCT00726999|B1|Baseline|Gabapentin/Morphine|Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed.
1036864|NCT00726999|P2|Participant Flow|Placebo/Morphine|Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed.
1036865|NCT00726999|P1|Participant Flow|Gabapentin/Morphine|Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed.
1036866|NCT00726999|O2|Outcome|Placebo/Morphine|Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed.
1036867|NCT00726999|O1|Outcome|Gabapentin/Morphine|Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed.
1036868|NCT00726999|O2|Outcome|Placebo/Morphine|Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed.
1036869|NCT00726999|O1|Outcome|Gabapentin/Morphine|Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed.
1036870|NCT00726999|O2|Outcome|Placebo/Morphine|Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed.
1036871|NCT00726999|O1|Outcome|Gabapentin/Morphine|Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed.
1036872|NCT00726999|E2|Reported Event|Placebo/Morphine|Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed.
1036873|NCT00726999|E1|Reported Event|Gabapentin/Morphine|Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed.
1036874|NCT00726661|B3|Baseline|Total|Total of all reporting groups
1036875|NCT00726661|B2|Baseline|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
1036876|NCT00726661|B1|Baseline|Chemotherapy Cohort|Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
1036877|NCT00726661|P2|Participant Flow|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
1036878|NCT00726661|P1|Participant Flow|Chemotherapy Cohort|Eligible participants with human epidermal growth factor receptor 2-negative (HER2-negative) disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
1036879|NCT00726661|O2|Outcome|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
1036880|NCT00726661|O1|Outcome|Chemotherapy Cohort|Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
1036881|NCT00726661|O2|Outcome|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
1036882|NCT00726661|O1|Outcome|Chemotherapy Cohort|Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
1036883|NCT00726661|O1|Outcome|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
1036884|NCT00726661|O2|Outcome|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
1036885|NCT00726661|O1|Outcome|Chemotherapy Cohort|Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
1036886|NCT00726661|O2|Outcome|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
1036887|NCT00726661|O1|Outcome|Chemotherapy Cohort|Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
1036888|NCT00726661|O2|Outcome|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
1036889|NCT00726661|O1|Outcome|Chemotherapy Cohort|Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
1036890|NCT00726661|E2|Reported Event|Hormonal Therapy Cohort|Eligible participants with hormone receptor positive disease who received their first hormonal therapy for advanced disease were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
1036891|NCT00726661|E1|Reported Event|Chemotherapy Cohort|Eligible participants with HER2-negative disease who received their first cytotoxic chemotherapy and/or targeted therapy were observed until death, withdrawal of consent, loss to follow-up, or until study closure, whichever was sooner (approximately 4.5 years).
1036892|NCT00726622|B3|Baseline|Total|Total of all reporting groups
1036893|NCT00726622|B2|Baseline|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
1036894|NCT00726622|B1|Baseline|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
1036895|NCT00726622|P2|Participant Flow|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
1036896|NCT00726622|P1|Participant Flow|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
1036897|NCT00726622|O2|Outcome|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
1036898|NCT00726622|O1|Outcome|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
1036899|NCT00726622|O2|Outcome|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
1036900|NCT00726622|O1|Outcome|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
1036901|NCT00726622|O2|Outcome|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
1036902|NCT00726622|O1|Outcome|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
1036903|NCT00726622|O2|Outcome|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
1036904|NCT00726622|O1|Outcome|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
1036905|NCT00726622|O2|Outcome|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
1036906|NCT00726622|O1|Outcome|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
1036907|NCT00726622|O2|Outcome|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
1036908|NCT00726622|O1|Outcome|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
1036909|NCT00726622|O2|Outcome|Arm 2: Laparoscopic-assisted Rectal Resection|Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.
1036910|NCT00726622|O1|Outcome|Arm 1: Open Laparotomy and Rectal Resection|Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
1036911|NCT00726622|E2|Reported Event|Arm 2: Laparoscopic-assisted Rectal Resection|Laparoscopic-assisted rectal resection: Patients undergo laparoscopic-assisted rectal resection.
1036912|NCT00726622|E1|Reported Event|Arm 1: Open Laparotomy and Rectal Resection|Open laparotomy and rectal resection: Patients undergo open laparotomy and rectal resection.
1036913|NCT00726609|B1|Baseline|Posaconazole (Assigned by Physician in Normal Practice)|"Treatment of invasive fungal infection.~Prophylaxis of invasive fungal infection."
1036914|NCT00726609|P1|Participant Flow|Posaconazole (Assigned by Physician in Normal Practice)|"Treatment of invasive fungal infection.~Prophylaxis of invasive fungal infection."
1036915|NCT00726609|O1|Outcome|Posaconazole (Assigned by Physician in Normal Practice)|"Treatment of invasive fungal infection.~Prophylaxis of invasive fungal infection."
1036916|NCT00726609|E1|Reported Event|Posaconazole (Assigned by Physician in Normal Practice)|
1036917|NCT00726557|B1|Baseline|PegIntron + Rebetol|Baseline measures only available for the 118 participants who completed.
1036918|NCT00726557|P1|Participant Flow|PegIntron + Rebetol|PegIntron 1.5 mcg/kg/week + Rebetol 10.6 mg/kg/day administered for a minimum of 12 weeks. Participants who achieved early virological response at Treatment Week 12 continued to receive therapy for a total of 24 or 48 weeks, depending on genotype.
1036919|NCT00726557|O1|Outcome|Participants Who Tolerated Treatment|Those who completed treatment.
1036920|NCT00726557|O1|Outcome|Participants With Negative HCV-RNA at End of Treatment|End of treatment is 24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4
1036921|NCT00726557|E1|Reported Event|PegIntron + Rebetol|PegIntron 1.5 mcg/kg/week + Rebetol 10.6 mg/kg/day administered for a minimum of 12 weeks. Participants who achieved early virological response at Treatment Week 12 continued to receive therapy for a total of 24 or 48 weeks, depending on genotype.
1036922|NCT00726453|B3|Baseline|Total|Total of all reporting groups
1036923|NCT00726453|B2|Baseline|38 mm Length Sub-study|All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required this group is the 38 mm Length Main study. Enrollment in this group opened after the Primary Enrollment Group had closed. This sub-study completed the primary endpoint in March 2012 results not yet available.
1036924|NCT00726453|B1|Baseline|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:~2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.~Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
1036925|NCT00726453|P2|Participant Flow|38 mm Length Sub-study|All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required this group is the 38 mm Length Main study. Enrollment in this group opened after the Primary Enrollment Group had closed.
1036926|NCT00726453|P1|Participant Flow|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:~2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.~Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
1036927|NCT00726453|O1|Outcome|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:~2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.~Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
1036928|NCT00726453|O1|Outcome|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:~2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.~Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
1036929|NCT00726453|O1|Outcome|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:~2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.~Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
1036930|NCT00726453|O1|Outcome|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:~2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.~Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
1036931|NCT00726453|O1|Outcome|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:~2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.~Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
1037040|NCT00725985|O3|Outcome|Placebo (ITP)|Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
1037133|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
1036932|NCT00726453|O1|Outcome|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:~2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study, or 38 mm Length Sub-study.~Patients enrolled in the 2.25 - 3.5 mm Main Study, the 2.25 mm - 3.5 mm Angio/IVUS Sub-study, and the 4.0 mm Sub-study are collectively referred to as the Primary Enrollment Group (PEG)."
1036933|NCT00726453|E2|Reported Event|38 mm Length Sub-Study|All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required this group is the 38 mm Length Main study. Enrollment in this group opened after the Primary Enrollment Group had closed.
1036934|NCT00726453|E1|Reported Event|Primary Enrollment Group|"All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. Patients were assigned in to one of four sub-studies based on the stent required:~2.25 mm - 3.5 mm Main study, 2.25 mm - 3.5 mm Angio/IVUS Sub-study, 4.0 mm Sub-study and are collectively referred to as the Primary Enrollment Group (PEG)."
1036935|NCT00726414|B1|Baseline|Quinine Sulfate Under Fed and Fasted Conditions|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one dose of Quinine Sulfate (2 x 324 mg capsules) following an overnight fast or 30 minutes following a standardized, high fat breakfast.
1036936|NCT00726414|P2|Participant Flow|Quinine Sulfate Under Fed Then Fasted Conditions|On the morning of Day 1 subjects received one dose of Quinine Sulfate (2 x 324 mg capsules) 30 minutes following a standardized, high fat breakfast, followed by a 7 day washout period. On the morning of Day 8 subjects received one dose of Quinine Sulfate (2 x 324 mg capsules) following an overnight fast of at least 10 hours.
1036937|NCT00726414|P1|Participant Flow|Quinine Sulfate Under Fasted Then Fed Conditions|On the morning of Day 1 subjects received one dose of Quinine Sulfate (2 x 324 mg capsules) after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one dose of Quinine Sulfate (2 x 324 mg capsules) 30 minutes following a standardized, high fat breakfast.
1036938|NCT00726414|O2|Outcome|Quinine Sulfate Under Fed Conditions|Each subject received two capsules of Quinine Sulfate 324 mg 30 minutes following a standardized, high fat breakfast.
1036939|NCT00726414|O1|Outcome|Quinine Sulfate Under Fasted Conditions|Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
1036940|NCT00726414|O2|Outcome|Quinine Sulfate Under Fed Conditions|Each subject received two capsules of Quinine Sulfate 324 mg 30 minutes following a standardized, high fat breakfast.
1036941|NCT00726414|O1|Outcome|Quinine Sulfate Under Fasted Conditions|Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
1036942|NCT00726414|O2|Outcome|Quinine Sulfate Under Fed Conditions|Each subject received two capsules of Quinine Sulfate 324 mg 30 minutes following a standardized, high fat breakfast.
1036943|NCT00726414|O1|Outcome|Quinine Sulfate Under Fasted Conditions|Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
1036944|NCT00726414|E2|Reported Event|Quinine Sulfate Under Fed Conditions|Each subject received two capsules of Quinine Sulfate 324 mg 30 minutes following a standardized, high fat breakfast.
1036945|NCT00726414|E1|Reported Event|Quinine Sulfate Under Fasted Conditions|Each subject received two capsules of Quinine Sulfate 324 mg after an overnight fast of at least 10 hours.
1036946|NCT00726375|B1|Baseline|Etanercept|"a maximum of 8 SQ doses of 'Etanercept (Enbrel) at 0.4mg/kg per dose up to a maximum of 25 mg per dose~Etanercept (Enbrel): Etanercept will begin within 72 hours of the diagnosis of Grade I acute GVHD and after consent for this study. Subjects receive eight doses of etanercept over four weeks. All doses will be administered by SQ injection. All subsequent doses will be given as subcutaneous injections into the skin. Injections will be given twice weekly with at least one day in between injections. The injections can be given in clinic, in the hospital, or self administered injections."
1036947|NCT00726375|P1|Participant Flow|Etanercept|"a maximum of 8 SQ doses of 'Etanercept (Enbrel) at 0.4mg/kg per dose up to a maximum of 25 mg per dose~Etanercept (Enbrel): Etanercept will begin within 72 hours of the diagnosis of Grade I acute GVHD and after consent for this study. Subjects receive eight doses of etanercept over four weeks. All doses will be administered by SQ injection. All subsequent doses will be given as subcutaneous injections into the skin. Injections will be given twice weekly with at least one day in between injections. The injections can be given in clinic, in the hospital, or self administered injections."
1036948|NCT00726375|O1|Outcome|Etanercept|"a maximum of 8 SQ doses of 'Etanercept (Enbrel) at 0.4mg/kg per dose up to a maximum of 25 mg per dose~Etanercept (Enbrel): Etanercept will begin within 72 hours of the diagnosis of Grade I acute GVHD and after consent for this study. Subjects receive eight doses of etanercept over four weeks. All doses will be administered by SQ injection. All subsequent doses will be given as subcutaneous injections into the skin. Injections will be given twice weekly with at least one day in between injections. The injections can be given in clinic, in the hospital, or self administered injections."
1036949|NCT00726375|O1|Outcome|Etanercept|"a maximum of 8 SQ doses of 'Etanercept (Enbrel) at 0.4mg/kg per dose up to a maximum of 25 mg per dose~Etanercept (Enbrel): Etanercept will begin within 72 hours of the diagnosis of Grade I acute GVHD and after consent for this study. Subjects receive eight doses of etanercept over four weeks. All doses will be administered by SQ injection. All subsequent doses will be given as subcutaneous injections into the skin. Injections will be given twice weekly with at least one day in between injections. The injections can be given in clinic, in the hospital, or self administered injections."
1036950|NCT00726375|E1|Reported Event|Etanercept|"a maximum of 8 SQ doses of 'Etanercept (Enbrel) at 0.4mg/kg per dose up to a maximum of 25 mg per dose~Etanercept (Enbrel): Etanercept will begin within 72 hours of the diagnosis of Grade I acute GVHD and after consent for this study. Subjects receive eight doses of etanercept over four weeks. All doses will be administered by SQ injection. All subsequent doses will be given as subcutaneous injections into the skin. Injections will be given twice weekly with at least one day in between injections. The injections can be given in clinic, in the hospital, or self administered injections."
1036951|NCT00726232|B7|Baseline|Total|Total of all reporting groups
1037087|NCT00725751|O1|Outcome|PegIFN-2b/Ribavirin With Substitution Therapy|Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
1036952|NCT00726232|B6|Baseline|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036953|NCT00726232|B5|Baseline|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036954|NCT00726232|B4|Baseline|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036955|NCT00726232|B3|Baseline|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036956|NCT00726232|B2|Baseline|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036957|NCT00726232|B1|Baseline|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036958|NCT00726232|P6|Participant Flow|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036959|NCT00726232|P5|Participant Flow|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036960|NCT00726232|P4|Participant Flow|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036961|NCT00726232|P3|Participant Flow|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036962|NCT00726232|P2|Participant Flow|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036963|NCT00726232|P1|Participant Flow|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036964|NCT00726232|O6|Outcome|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1037041|NCT00725985|O2|Outcome|Cladribine 3.5 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
1052582|NCT00687674|O1|Outcome|Sorafenib + Lenalidomide + Dexamethasone|
1036965|NCT00726232|O5|Outcome|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036966|NCT00726232|O4|Outcome|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036967|NCT00726232|O3|Outcome|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036968|NCT00726232|O2|Outcome|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036969|NCT00726232|O1|Outcome|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036970|NCT00726232|O3|Outcome|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036971|NCT00726232|O2|Outcome|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036972|NCT00726232|O1|Outcome|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036973|NCT00726232|O3|Outcome|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036974|NCT00726232|O2|Outcome|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036975|NCT00726232|O1|Outcome|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036976|NCT00726232|O3|Outcome|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036977|NCT00726232|O2|Outcome|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036978|NCT00726232|O1|Outcome|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036979|NCT00726232|O3|Outcome|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036980|NCT00726232|O2|Outcome|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036981|NCT00726232|O1|Outcome|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036982|NCT00726232|O3|Outcome|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036983|NCT00726232|O2|Outcome|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036984|NCT00726232|O1|Outcome|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036985|NCT00726232|O3|Outcome|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036986|NCT00726232|O2|Outcome|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036987|NCT00726232|O1|Outcome|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036988|NCT00726232|O3|Outcome|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036989|NCT00726232|O2|Outcome|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036990|NCT00726232|O1|Outcome|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036991|NCT00726232|O3|Outcome|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036992|NCT00726232|O2|Outcome|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036993|NCT00726232|O1|Outcome|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036994|NCT00726232|O3|Outcome|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036995|NCT00726232|O2|Outcome|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036996|NCT00726232|O1|Outcome|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036997|NCT00726232|O3|Outcome|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036998|NCT00726232|O2|Outcome|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1036999|NCT00726232|O1|Outcome|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1037000|NCT00726232|E6|Reported Event|ET: Ruxolitinib 50 mg QD|Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1037001|NCT00726232|E5|Reported Event|ET: Ruxolitinib 25 mg BID|Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1037002|NCT00726232|E4|Reported Event|ET: Ruxolitinib 10 mg BID|Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1037003|NCT00726232|E3|Reported Event|PV: Ruxolitinib 50 mg QD|Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1037004|NCT00726232|E2|Reported Event|PV: Ruxolitinib 25 mg BID|Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1037005|NCT00726232|E1|Reported Event|PV: Ruxolitinib 10 mg BID|Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
1037042|NCT00725985|O1|Outcome|Cladribine 5.25 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
1037134|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
1037006|NCT00726180|B1|Baseline|Treatment Arm|trastuzumab (Herceptin®) : About 1 week (4 - 7 days) before scheduled breast surgery, consisting of lumpectomy or mastectomy, subjects will receive a dose of trastuzumab (Herceptin®). Trastuzumab will be given through an IV or port for approximately 90 minutes. During this time, subjects will be closely monitored by a chemotherapy nurse to make sure that subjects do not have a reaction to the medication. It is possible that the infusion of the medication will need to be slowed down, in which case, the time for the infusion will be longer than 90 minutes. The one dose of the trastuzumab drug will be provided by the study (not billed to insurance), but the charges to administer the drug will be billed to subjects or subjects health insurance.
1037007|NCT00726180|P1|Participant Flow|Treatment Arm|trastuzumab (Herceptin®) : About 1 week (4 - 7 days) before scheduled breast surgery, consisting of lumpectomy or mastectomy, subjects will receive a dose of trastuzumab (Herceptin®). Trastuzumab will be given through an IV or port for approximately 90 minutes. During this time, subjects will be closely monitored by a chemotherapy nurse to make sure that subjects do not have a reaction to the medication. It is possible that the infusion of the medication will need to be slowed down, in which case, the time for the infusion will be longer than 90 minutes. The one dose of the trastuzumab drug will be provided by the study (not billed to insurance), but the charges to administer the drug will be billed to subjects or subjects health insurance.
1037008|NCT00726180|O1|Outcome|Treatment Arm|trastuzumab (Herceptin®) : About 1 week (4 - 7 days) before scheduled breast surgery, consisting of lumpectomy or mastectomy, subjects will receive a dose of trastuzumab (Herceptin®). Trastuzumab will be given through an IV or port for approximately 90 minutes. During this time, subjects will be closely monitored by a chemotherapy nurse to make sure that subjects do not have a reaction to the medication. It is possible that the infusion of the medication will need to be slowed down, in which case, the time for the infusion will be longer than 90 minutes. The one dose of the trastuzumab drug will be provided by the study (not billed to insurance), but the charges to administer the drug will be billed to subjects or subjects health insurance.
1037009|NCT00726180|E1|Reported Event|Treatment Arm|trastuzumab (Herceptin®) : About 1 week (4 - 7 days) before scheduled breast surgery, consisting of lumpectomy or mastectomy, subjects will receive a dose of trastuzumab (Herceptin®). Trastuzumab will be given through an IV or port for approximately 90 minutes. During this time, subjects will be closely monitored by a chemotherapy nurse to make sure that subjects do not have a reaction to the medication. It is possible that the infusion of the medication will need to be slowed down, in which case, the time for the infusion will be longer than 90 minutes. The one dose of the trastuzumab drug will be provided by the study (not billed to insurance), but the charges to administer the drug will be billed to subjects or subjects health insurance.
1037010|NCT00726063|B3|Baseline|Total|Total of all reporting groups
1037011|NCT00726063|B2|Baseline|Osseotite Implant|"Osseotite dental implant~Osseotite dental implant : Osseotite Root form titanium dental implant"
1037012|NCT00726063|B1|Baseline|Nanotite Implant|"Nanotite dental implant~Nanotite dental implant : Nanotite root form titanium dental implant"
1037013|NCT00726063|P2|Participant Flow|Osseotite Implant|"Osseotite dental implant~Osseotite dental implant : Osseotite Root form titanium dental implant"
1037014|NCT00726063|P1|Participant Flow|Nanotite Implant|"Nanotite dental implant~Nanotite dental implant : Nanotite root form titanium dental implant"
1037015|NCT00726063|O2|Outcome|Osseotite Implant|"Osseotite dental implant~Osseotite dental implant : Osseotite Root form titanium dental implant"
1037016|NCT00726063|O1|Outcome|Nanotite Implant|"Nanotite dental implant~Nanotite dental implant : Nanotite root form titanium dental implant"
1037017|NCT00726063|E2|Reported Event|Osseotite Implant|"Osseotite dental implant~Osseotite dental implant : Osseotite Root form titanium dental implant"
1037018|NCT00726063|E1|Reported Event|Nanotite Implant|"Nanotite dental implant~Nanotite dental implant : Nanotite root form titanium dental implant"
1037019|NCT00726037|B1|Baseline|Ontak|Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
1037020|NCT00726037|P1|Participant Flow|Ontak|Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
1037021|NCT00726037|O1|Outcome|Ontak|Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
1037022|NCT00726037|O1|Outcome|Ontak|Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
1037023|NCT00726037|E1|Reported Event|Ontak|Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
1037024|NCT00725985|B4|Baseline|Total|Total of all reporting groups
1037025|NCT00725985|B3|Baseline|Placebo|Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first. Participants who converted to CDMS during ITP entered OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Participants who did not convert to CDMS during ITP, entered in LTFU period. Participants who converted to McDonald MS during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any study treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period.
1037026|NCT00725985|B2|Baseline|Cladribine 3.5 mg/kg|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first. Participants who converted to CDMS during ITP entered OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Participants who did not convert to CDMS during ITP, entered in (LTFU period. Participants who converted to McDonald MS during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any study treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period.
1037043|NCT00725985|O3|Outcome|Placebo (ITP)|Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
1037088|NCT00725751|O2|Outcome|PegIFN-2b/Ribavirin Without Substitution Therapy|Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
1037027|NCT00725985|B1|Baseline|Cladribine 5.25 mg/kg|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first. Participants who converted to CDMS during ITP entered OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Participants who did not convert to CDMS during ITP, entered in (LTFU period. Participants who converted to McDonald MS during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period.
1037028|NCT00725985|P12|Participant Flow|Placebo, Rebif (LTFU)|Participants who received placebo and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who convert to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
1037029|NCT00725985|P11|Participant Flow|Cladribine 3.5 mg/kg, Rebif (LTFU)|Participants who received cladribine 3.5 mg/kg and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
1037030|NCT00725985|P10|Participant Flow|Cladribine 5.25 mg/kg, Rebif (LTFU)|Participants who received cladribine 5.25 mg/kg and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
1037031|NCT00725985|P9|Participant Flow|Placebo, Rebif, Cladribine 3.5 mg/kg (LTFU)|Participants who received placebo and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
1037032|NCT00725985|P8|Participant Flow|Cladribine 3.5 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU)|Participants who received cladribine 3.5 mg/kg and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
1037033|NCT00725985|P7|Participant Flow|Cladribine 5.25 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU)|Participants who received cladribine 5.25 mg/kg and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
1037034|NCT00725985|P6|Participant Flow|Placebo, Rebif (OLMP)|Participants who received placebo and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
1037035|NCT00725985|P5|Participant Flow|Cladribine 3.5 mg/kg, Rebif (OLMP)|Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
1037036|NCT00725985|P4|Participant Flow|Cladribine 5.25 mg/kg, Rebif (OLMP)|Participants who received cladribine 5.25 mg/kg and converted to CDMS during ITP entered in open-label maintenance period (OLMP) and received Rebif® new formulation (RNF) subcutaneously at a dose of 44 microgram (mcg) three times a week for up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
1037037|NCT00725985|P3|Participant Flow|Placebo (ITP)|Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
1037038|NCT00725985|P2|Participant Flow|Cladribine 3.5 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
1037039|NCT00725985|P1|Participant Flow|Cladribine 5.25 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the initial treatment period (ITP) of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
1037132|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
1037044|NCT00725985|O2|Outcome|Cladribine 3.5 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
1037045|NCT00725985|O1|Outcome|Cladribine 5.25 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
1037046|NCT00725985|O3|Outcome|Placebo (ITP)|Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
1037047|NCT00725985|O2|Outcome|Cladribine 3.5 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
1037048|NCT00725985|O1|Outcome|Cladribine 5.25 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
1037049|NCT00725985|O3|Outcome|Placebo (ITP)|Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
1037050|NCT00725985|O2|Outcome|Cladribine 3.5 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
1037051|NCT00725985|O1|Outcome|Cladribine 5.25 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
1037052|NCT00725985|E12|Reported Event|Placebo, Rebif (LTFU)|Participants who received placebo and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who convert to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
1037053|NCT00725985|E11|Reported Event|Cladribine 3.5 mg/kg, Rebif (LTFU)|Participants who received cladribine 3.5 mg/kg and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
1037054|NCT00725985|E10|Reported Event|Cladribine 5.25 mg/kg, Rebif (LTFU)|Participants who received cladribine 5.25 mg/kg and did not convert to CDMS during ITP, entered in LTFU period. Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU period received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
1037055|NCT00725985|E9|Reported Event|Placebo, Rebif, Cladribine 3.5 mg/kg (LTFU)|Participants who received placebo and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period . Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
1037056|NCT00725985|E8|Reported Event|Cladribine 3.5 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU)|Participants who received cladribine 3.5 mg/kg and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period . Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
1037057|NCT00725985|E7|Reported Event|Cladribine 5.25 mg/kg, Rebif, Cladribine 3.5 mg/kg (LTFU)|Participants who received cladribine 5.25 mg/kg and did not convert to CDMS during ITP, entered in long-term follow-up (LTFU) period. Participants who converted to McDonald multiple sclerosis (MS) during ITP or during LTFU period received open-label cladribine tablets (3.5 mg/kg) during LTFU period . Participants who did not convert to McDonald MS during ITP did not receive any treatment during LTFU period. Participants who converted to CDMS during LTFU received RNF subcutaneously at a dose of 44 mcg three times a week for the remaining LTFU period. Under the original study design, total duration of LTFU period was up to 96 weeks. The LTFU duration was reduced due to trial termination. Following the notice of trial termination, no further open label cladribine treatment was administered during the LTFU.
1037086|NCT00725751|O2|Outcome|PegIFN-2b/Ribavirin Without Substitution Therapy|Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
1037058|NCT00725985|E6|Reported Event|Placebo, Rebif (OLMP)|Participants who received placebo and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
1037059|NCT00725985|E5|Reported Event|Cladribine 3.5 mg/kg, Rebif (OLMP)|Participants who received cladribine 3.5 mg/kg and converted to CDMS during ITP entered in OLMP and received RNF subcutaneously at a dose of 44 mcg three times a week up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
1037060|NCT00725985|E4|Reported Event|Cladribine 5.25 mg/kg, Rebif (OLMP)|Participants who received cladribine 5.25 mg/kg and converted to CDMS during ITP entered in open-label maintenance period (OLMP) and received Rebif® new formulation (RNF) subcutaneously at a dose of 44 microgram (mcg) three times a week up to 96 weeks. Due to trial termination, the OLMP duration was reduced for some participants.
1037061|NCT00725985|E3|Reported Event|Placebo (ITP)|Placebo matched to cladribine tablets administered over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48 and 52 during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
1037062|NCT00725985|E2|Reported Event|Cladribine 3.5 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 mg/kg over a course of 5 consecutive days at Weeks 1, 5, 48, 52 and placebo matched to cladribine tablets was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the ITP of 96 weeks or until CDMS conversion, whichever occurred first.
1037063|NCT00725985|E1|Reported Event|Cladribine 5.25 mg/kg (ITP)|Cladribine tablets administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the initial treatment period (ITP) of 96 weeks or until clinically definite multiple sclerosis (CDMS) conversion, whichever occurred first.
1037064|NCT00725920|B3|Baseline|Total|Total of all reporting groups
1037065|NCT00725920|B2|Baseline|Control Group|patients received pills content placebo, that were identical to the pills content active drug
1037066|NCT00725920|B1|Baseline|Topiramate|patients receiving the active drug: topiramate
1037067|NCT00725920|P2|Participant Flow|Control Group|patients receiving placebo pills, that were identical to the pills content active drug, starting at 25 mg/d once daily, at night and increased in 25 mg weekly, as tolerated, until complete or nearly complete efficacy was achieved or until maximum dose allowed was reached (200 mg/d).
1037068|NCT00725920|P1|Participant Flow|Topiramate|patients receiving the active drug: topiramate. Patients will receive topiramate pills, starting at 25 mg/d once daily, at night and increased in 25 mg weekly, as tolerated, until complete or nearly complete efficacy was achieved or until maximum dose allowed was reached (200 mg/d).
1037069|NCT00725920|O2|Outcome|Control Group|patients received pills content placebo, that were identical to the pills content active drug
1037070|NCT00725920|O1|Outcome|Topiramate|patients receiving the active drug: topiramate
1037071|NCT00725920|E2|Reported Event|Control Group|patients received pills content placebo, that were identical to the pills content active drug
1037072|NCT00725920|E1|Reported Event|Topiramate|patients receiving the active drug: topiramate
1037073|NCT00725842|B1|Baseline|Peg-IFN Alfa-2b + Ribavirin|Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
1037074|NCT00725842|P1|Participant Flow|Peg-IFN Alfa-2b + Ribavirin|Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
1037075|NCT00725842|O1|Outcome|Peg-IFN Alfa-2b + Ribavirin|Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
1037076|NCT00725842|O1|Outcome|Peg-IFN Alfa-2b + Ribavirin|Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
1037077|NCT00725842|O1|Outcome|Peg-IFN Alfa-2b + Ribavirin|Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
1037078|NCT00725842|O1|Outcome|Peg-IFN Alfa-2b + Ribavirin|Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
1037079|NCT00725842|E1|Reported Event|Peg-IFN Alfa-2b + Ribavirin|Participants with chronic hepatitis C (CHC) treated with Peg-IFN alfa-2b + ribavirin as first treatment, in common clinical practice, who had negative hepatitis-C virus (HCV)-ribonucleic acid (RNA) by the end of treatment (24 or 48 weeks per product labeling).
1037080|NCT00725751|B3|Baseline|Total|Total of all reporting groups
1037081|NCT00725751|B2|Baseline|PegIFN-2b/Ribavirin Without Substitution Therapy|Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
1037082|NCT00725751|B1|Baseline|PegIFN-2b/Ribavirin With Substitution Therapy|Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
1037083|NCT00725751|P2|Participant Flow|PegIFN-2b/Ribavirin Without Substitution Therapy|Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
1037084|NCT00725751|P1|Participant Flow|PegIFN-2b/Ribavirin With Substitution Therapy|Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
1037085|NCT00725751|O1|Outcome|All Participants|"Participants who received at least one dose of antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)~Participants who received at least one dose of antiviral treatment and did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)"
1037089|NCT00725751|O1|Outcome|PegIFN-2b/Ribavirin With Substitution Therapy|Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
1037090|NCT00725751|E2|Reported Event|PegIFN-2b/Ribavirin Without Substitution Therapy|Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
1037091|NCT00725751|E1|Reported Event|PegIFN-2b/Ribavirin With Substitution Therapy|Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine)
1037092|NCT00725725|B4|Baseline|Total|Total of all reporting groups
1037093|NCT00725725|B3|Baseline|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
1037094|NCT00725725|B2|Baseline|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
1037095|NCT00725725|B1|Baseline|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
1037096|NCT00725725|P3|Participant Flow|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
1037097|NCT00725725|P2|Participant Flow|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
1037098|NCT00725725|P1|Participant Flow|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
1037099|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
1037100|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
1037101|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
1037102|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
1037103|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
1037104|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
1037105|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
1037106|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
1037107|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
1037108|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
1037109|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
1037110|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
1037111|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
1037112|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
1037113|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
1037114|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
1037115|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
1037116|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
1037117|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
1037118|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
1037119|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
1037120|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
1037121|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
1037122|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
1037123|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
1037124|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
1037125|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
1037126|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
1037127|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
1037128|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
1037129|NCT00725725|O3|Outcome|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
1037130|NCT00725725|O2|Outcome|12 mg Org 25935|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
1037131|NCT00725725|O1|Outcome|4 mg Org 25935|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
1037667|NCT00724594|O1|Outcome|NAC Maternal|Mothers treated with N-acetylcysteine prior to delivery
1037135|NCT00725725|E3|Reported Event|Placebo|Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
1037136|NCT00725725|E2|Reported Event|Org 25935 12 mg|Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
1037137|NCT00725725|E1|Reported Event|Org 25935 4 mg|Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
1037138|NCT00725621|B1|Baseline|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
1037139|NCT00725621|P1|Participant Flow|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
1037140|NCT00725621|O2|Outcome|Remicade (Extramural Infusion Centers Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
1037141|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
1037142|NCT00725621|O2|Outcome|Remicade (Extramural Infusion Centers Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
1037143|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
1037144|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
1037145|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
1037146|NCT00725621|O3|Outcome|Remicade (Extramural Infusion Centers Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
1037147|NCT00725621|O2|Outcome|Remicade (Specialized Hospitals Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
1037148|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
1037149|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
1037150|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
1037200|NCT00725452|P1|Participant Flow|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
1053904|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
1037151|NCT00725621|O3|Outcome|Remicade (Extramural Infusion Centers Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
1037152|NCT00725621|O2|Outcome|Remicade (Specialized Hospitals Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
1037153|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
1037154|NCT00725621|O3|Outcome|Remicade (Extramural Infusion Centers Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
1037155|NCT00725621|O2|Outcome|Remicade (Specialized Hospitals Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
1037156|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
1037157|NCT00725621|O3|Outcome|Remicade (Extramural Infusion Centers Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
1037158|NCT00725621|O2|Outcome|Remicade (Specialized Hospitals Only)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
1037159|NCT00725621|O1|Outcome|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
1037160|NCT00725621|E1|Reported Event|Remicade (Specialized Hospitals & Extramural Infusion Centers)|Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
1037161|NCT00725608|B1|Baseline|Opioid Dependent Patients|Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
1037162|NCT00725608|P1|Participant Flow|Opioid Dependent Patients|Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
1037163|NCT00725608|O1|Outcome|Opioid Dependent Patients|Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
1037164|NCT00725608|O1|Outcome|Opioid Dependent Patients|Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
1037165|NCT00725608|O1|Outcome|Opioid Dependent Patients|Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
1037166|NCT00725608|E1|Reported Event|Opioid Dependent Patients|Opioid dependent patients currently in maintenance treatment with another medication who are switched to Suboxone (buprenorphine plus naloxone)
1037167|NCT00725543|B1|Baseline|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
1037168|NCT00725543|P1|Participant Flow|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
1037248|NCT00725153|E1|Reported Event|PureVision Lenses Worn 10 Hours|PureVision lenses worn 10 hours
1037249|NCT00725101|B1|Baseline|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
1037169|NCT00725543|O1|Outcome|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
1037170|NCT00725543|O1|Outcome|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
1037171|NCT00725543|O1|Outcome|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
1037172|NCT00725543|O1|Outcome|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
1037173|NCT00725543|O1|Outcome|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
1037174|NCT00725543|O1|Outcome|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
1037175|NCT00725543|E1|Reported Event|Remicade|Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
1037176|NCT00725530|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed participants.
1037177|NCT00725530|P2|Participant Flow|Etafilcon A / Balafilcon A|Etafilcon A worn first, with balafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days.
1037178|NCT00725530|P1|Participant Flow|Balafilcon A / Etafilcon A|Balafilcon A worn first, with etafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days.
1037179|NCT00725530|O2|Outcome|Etafilcon A|Commercially marketed, hydrogel, soft contact lenses worn for 7 days on an extended wear (overnight) basis.
1037180|NCT00725530|O1|Outcome|Balafilcon A|Commercially marketed, silicone hydrogel, soft contact lenses worn for 7 days on an extended wear (overnight) basis.
1037181|NCT00725530|E2|Reported Event|Etafilcon A|Commercially marketed, hydrogel, soft contact lenses worn for 7 days on an extended wear (overnight) basis.
1037182|NCT00725530|E1|Reported Event|Balafilcon A Contact Lenses|Commercially marketed, silicone hydrogel, soft contact lenses worn for 7 days on an extended wear (overnight) basis.
1037183|NCT00725504|B1|Baseline|Lidocaine Infusion|"Each participant will receive an intravenous infusion of lidocaine. Plasma concentrations will be increased gradually from 0-5 ug/ml.~Intravenous lidocaine: Intravenous lidocaine administered during fMRI scan at a maximum dose of 3mcg/ml"
1037184|NCT00725504|P1|Participant Flow|Lidocaine Infusion|"Each participant will receive an intravenous infusion of lidocaine. Plasma concentrations will be increased gradually from 0-5 ug/ml.~Intravenous lidocaine: Intravenous lidocaine administered during fMRI scan at a maximum dose of 3mcg/ml"
1037185|NCT00725504|O4|Outcome|Lidocaine 5 µg/ml|Each participant received an intravenous infusion of 5 µg/ml of lidocaine.
1037186|NCT00725504|O3|Outcome|Lidocaine 3 µg/ml|Each participant received an intravenous infusion of 3 µg/ml of lidocaine.
1037187|NCT00725504|O2|Outcome|Placebo|Each participant received a placebo-saline infusion.
1037188|NCT00725504|O1|Outcome|Baseline|Each participant was tested at the zero infusion rate.
1037189|NCT00725504|E1|Reported Event|Lidocaine Infusion|Each participant will receive an intravenous infusion of lidocaine. Plasma concentrations will be increased gradually from 0-5 µg/ml.
1037190|NCT00725491|B3|Baseline|Total|Total of all reporting groups
1037191|NCT00725491|B2|Baseline|Triptorelin|0.05 mg once daily from cycle day 21-24 onwards up to the day of hCG
1037192|NCT00725491|B1|Baseline|Ganirelix|0.25 mg once daily from stimulation day 6 onwards up to the day of human chorionic gonadotropin (hCG).
1037193|NCT00725491|P2|Participant Flow|Triptorelin|0.05 mg once daily from cycle day 21-24 onwards up to the day of hCG
1037194|NCT00725491|P1|Participant Flow|Ganirelix|0.25 mg once daily from stimulation day 6 onwards up to the day of human chorionic gonadotropin (hCG).
1037195|NCT00725491|O2|Outcome|Triptorelin|0.05 mg once daily from cycle day 21-24 onwards up to the day of hCG
1037196|NCT00725491|O1|Outcome|Ganirelix|0.25 mg once daily from stimulation day 6 onwards up to the day of human chorionic gonadotropin (hCG).
1037197|NCT00725491|E2|Reported Event|Triptorelin|0.05 mg once daily from cycle day 21-24 onwards up to the day of hCG
1037198|NCT00725491|E1|Reported Event|Ganirelix|0.25 mg once daily from stimulation day 6 onwards up to the day of human chorionic gonadotropin (hCG).
1037199|NCT00725452|B1|Baseline|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
1037201|NCT00725452|O1|Outcome|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
1037202|NCT00725452|O1|Outcome|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
1037203|NCT00725452|O1|Outcome|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
1037204|NCT00725452|O1|Outcome|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
1037205|NCT00725452|O1|Outcome|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
1037206|NCT00725452|O1|Outcome|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
1037207|NCT00725452|E1|Reported Event|Infliximab|Infliximab induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 mg/kg) given in doses and intervals at the discretion of the physician.
1037208|NCT00725361|B1|Baseline|Active|"Ambrisentan~Ambrisentan"
1037209|NCT00725361|P1|Participant Flow|Ambrisentan|5 mg orally daily X 4 weeks then 10 mg daily as tolerated
1037210|NCT00725361|O1|Outcome|Active|"Ambrisentan~Ambrisentan"
1037211|NCT00725361|O1|Outcome|Active|"Ambrisentan~Ambrisentan"
1037212|NCT00725361|O1|Outcome|Active|"Ambrisentan~Ambrisentan"
1037213|NCT00725361|O1|Outcome|Active|"Ambrisentan~Ambrisentan"
1037214|NCT00725361|O1|Outcome|Active|"Ambrisentan~Ambrisentan"
1037215|NCT00725361|E1|Reported Event|Active|"Ambrisentan~Ambrisentan"
1037216|NCT00725296|B1|Baseline|Infliximab|Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
1037217|NCT00725296|P1|Participant Flow|Infliximab|Participants with active and progressive psoriatic arthritis (PsA) who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
1037218|NCT00725296|O1|Outcome|Infliximab|Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
1037219|NCT00725296|O1|Outcome|Infliximab|Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
1037220|NCT00725296|O1|Outcome|Infliximab|Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
1037221|NCT00725296|O1|Outcome|Infliximab|Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
1037250|NCT00725101|P1|Participant Flow|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
1037222|NCT00725296|O1|Outcome|Infliximab|Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
1037223|NCT00725296|O1|Outcome|Infliximab|Participants with active and progressive psoriatic PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
1037224|NCT00725296|E1|Reported Event|Infliximab|Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
1037225|NCT00725270|B3|Baseline|Total|Total of all reporting groups
1037226|NCT00725270|B2|Baseline|Mifepristone|Patients will be randomized to mifepristone
1037227|NCT00725270|B1|Baseline|Placebo|Patients will be randomized to placebo
1037228|NCT00725270|P2|Participant Flow|Mifepristone|Patients will be randomized to mifepristone
1037229|NCT00725270|P1|Participant Flow|Placebo|Patients will be randomized to placebo
1037230|NCT00725270|O2|Outcome|Mifepristone|Patients will be randomized to mifepristone
1037231|NCT00725270|O1|Outcome|Placebo|Patients will be randomized to placebo
1037232|NCT00725270|O2|Outcome|Mifepristone|Patients will be randomized to mifepristone
1037233|NCT00725270|O1|Outcome|Placebo|Patients will be randomized to placebo
1037234|NCT00725270|E2|Reported Event|Mifepristone|Patients will be randomized to mifepristone
1037235|NCT00725270|E1|Reported Event|Placebo|Patients will be randomized to placebo
1037236|NCT00725205|B1|Baseline|Peginterferon Alfa-2b and Ribavirin|Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
1037237|NCT00725205|P1|Participant Flow|Peginterferon Alfa-2b and Ribavirin|Previously untreated Chronic Hepatitis C (CHC) participants treated with a treatment regimen of 1.5 micgrograms (mcg)/killogram (kg) Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
1037238|NCT00725205|O1|Outcome|Peginterferon Alfa-2b and Ribavirin|Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
1037239|NCT00725205|O1|Outcome|Peginterferon Alfa-2b and Ribavirin|Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
1037240|NCT00725205|O1|Outcome|Peginterferon Alfa-2b and Ribavirin|Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
1037241|NCT00725205|E1|Reported Event|Peginterferon Alfa-2b and Ribavirin|Previously untreated CHC participants treated with a treatment regimen of 1.5 mcg/kg Peginterferon alfa-2b (injection pen) and weight based daily Ribavirin capsules combination therapy as their usual medical treatment administered according to the product's labeling and current practice in Hungary for 12 weeks. Those participants whose continued treatment was warranted beyond Week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
1037242|NCT00725153|B1|Baseline|Overall|All enrolled participants
1037243|NCT00725153|P2|Participant Flow|Acuvue 2 / PureVision|Acuvue 2 lenses worn in Period One, PureVision lenses worn in Period Two. Both products worn for 10 hours each.
1037244|NCT00725153|P1|Participant Flow|PureVision / Acuvue 2|PureVision lenses worn in Period One, Acuvue 2 lenses worn in Period Two. Both products worn for 10 hours each.
1037245|NCT00725153|O2|Outcome|Acuvue 2 Contact Lenses|Acuvue 2 lenses worn 10 hours
1037246|NCT00725153|O1|Outcome|PureVision Contact Lenses|PureVision lenses worn 10 hours
1037247|NCT00725153|E2|Reported Event|Acuvue 2 Lenses Worn 10 Hours|Acuvue 2 lenses worn 10 hours
1053905|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
1037252|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
1037253|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
1037254|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
1037255|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
1037256|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
1037257|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
1037258|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
1037259|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
1037260|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
1037261|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
1037262|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
1037263|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
1037264|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
1037265|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
1037266|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
1037267|NCT00725101|O1|Outcome|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
1037268|NCT00725101|E1|Reported Event|Fibromyalgia (FM) Participants|FM participants starting any new pharmacologic FM agent.
1037269|NCT00725075|B4|Baseline|Total|Total of all reporting groups
1037270|NCT00725075|B3|Baseline|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
1037271|NCT00725075|B2|Baseline|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
1037272|NCT00725075|B1|Baseline|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
1037273|NCT00725075|P3|Participant Flow|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
1037274|NCT00725075|P2|Participant Flow|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
1037275|NCT00725075|P1|Participant Flow|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
1037276|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
1037277|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
1037278|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
1037279|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
1037280|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
1037281|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
1037282|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
1037363|NCT00724958|O1|Outcome|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
1053906|NCT00684307|O5|Outcome|VKA INR 2-3|
1037283|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
1037284|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
1037285|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
1037286|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
1037287|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
1037288|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
1037289|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
1037290|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
1037291|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
1037292|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
1037293|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
1037294|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
1037295|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
1037296|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
1037297|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
1037298|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
1037299|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
1037300|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
1037301|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
1037414|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037302|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
1037303|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
1037304|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
1037305|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
1037306|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
1037307|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
1037308|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
1037309|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
1037310|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
1037311|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
1037312|NCT00725075|O3|Outcome|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
1037313|NCT00725075|O2|Outcome|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
1037314|NCT00725075|O1|Outcome|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
1037315|NCT00725075|E3|Reported Event|Placebo|Participants were maintained on a stable dose of SGA and received matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days.
1037316|NCT00725075|E2|Reported Event|MK-8435 (Org 25935) 24-32 mg Per Day|Participants were maintained on a stable dose of SGA and received 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
1037317|NCT00725075|E1|Reported Event|MK-8435 (Org 25935) 8-16 mg Per Day|Participants were maintained on a stable dose of Second Generation Antipsychotic (SGA) and received 4-8 mg MK-8435 (Org 25935) twice a day (BID), in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) was titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose remained stable after Day 42 for the remainder of the study.
1037318|NCT00725049|B3|Baseline|Total|Total of all reporting groups
1037319|NCT00725049|B2|Baseline|Control Group|Dental implants of standard length placed simultaneously with sinus augmentation
1037320|NCT00725049|B1|Baseline|Dental Implant (Nanotite)|Dental implants of short length placed without sinus lifts
1037321|NCT00725049|P2|Participant Flow|Control Group|Dental implants of standard length placed simultaneously with sinus augmentation
1037322|NCT00725049|P1|Participant Flow|Dental Implant (Nanotite)|Dental implants of short length placed without sinus lifts
1037323|NCT00725049|O2|Outcome|Control Group|Dental implants of standard length placed simultaneously with sinus augmentation
1037324|NCT00725049|O1|Outcome|Dental Implant (Nanotite)|Dental implants of short length placed without sinus lifts
1037325|NCT00725049|E2|Reported Event|Control Group|Dental implants of standard length placed simultaneously with sinus augmentation
1037326|NCT00725049|E1|Reported Event|Dental Implant (Nanotite)|Dental implants of short length placed without sinus lifts
1037327|NCT00725010|B1|Baseline|Planned Temozolomide+Radiotherapy|Subjects with newly diagnosed Glioblastoma multiforme. Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.
1037328|NCT00725010|P1|Participant Flow|Planned Temozolomide+Radiotherapy|Subjects with newly diagnosed Glioblastoma multiforme. Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.
1037329|NCT00725010|O2|Outcome|Temozolomide Alone|Participants with newly diagnosed Glioblastoma multiforme treated with temozolomide alone (despite the study plan, 6 participants only received temozolomide and no radiotherapy; results are presented separately for these 6 participants). Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles.
1037330|NCT00725010|O1|Outcome|Temozolomide+Radiotherapy|Participants with newly diagnosed Glioblastoma multiforme who received temozolomide + radiotherapy during the combined therapy phase (per-protocol treatment). Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.
1037331|NCT00725010|O2|Outcome|Temozolomide Alone|Participants with newly diagnosed Glioblastoma multiforme treated with temozolomide alone (despite the study plan, 6 participants only received temozolomide and no radiotherapy; results are presented separately for these 6 participants). Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles.
1037332|NCT00725010|O1|Outcome|Temozolomide+Radiotherapy|Participants with newly diagnosed Glioblastoma multiforme who received temozolomide + radiotherapy during the combined therapy phase (per-protocol treatment). Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.
1037333|NCT00725010|E2|Reported Event|Temozolomide Alone|Participants with newly diagnosed Glioblastoma multiforme treated with temozolomide alone (despite the study plan, 6 participants only received temozolomide and no radiotherapy; results are presented separately for these 6 participants). Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles.
1037334|NCT00725010|E1|Reported Event|Temozolomide+Radiotherapy|Participants with newly diagnosed Glioblastoma multiforme who received temozolomide + radiotherapy during the combined therapy phase (per-protocol treatment). Temozolomide was administered orally once daily at 75 mg/m^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m^2 to 200 mg/m^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.
1037335|NCT00724984|B7|Baseline|Total|Total of all reporting groups
1037336|NCT00724984|B6|Baseline|Mantle Cell Lymphoma/Phase II|
1037337|NCT00724984|B5|Baseline|Follicular/Phase II|
1037338|NCT00724984|B4|Baseline|Cohort 4(60 mg/m2,7days/wk)/Phase 1|
1037339|NCT00724984|B3|Baseline|Cohort 3(45 mg/m2, 7days/wk)/Phase 1|
1037340|NCT00724984|B2|Baseline|Cohort 2(45 mg/m2, 5days/wk)/Phase 1|
1037341|NCT00724984|B1|Baseline|Cohort 1(30 mg/m2, 5days/wk)/Phase 1|
1037342|NCT00724984|P6|Participant Flow|Mantle Cell Lymphoma/Phase II|
1037343|NCT00724984|P5|Participant Flow|Follicular/Phase II|
1037344|NCT00724984|P4|Participant Flow|Cohort 4(60mg/m2,7days/wk)/Phase 1|
1037345|NCT00724984|P3|Participant Flow|Cohort 3(45mg/m2,7days/wk)/Phase 1|
1037346|NCT00724984|P2|Participant Flow|Cohort 2(45mg/m2,5days/wk)/Phase 1|
1037347|NCT00724984|P1|Participant Flow|Cohort 1(30mg/m2,5days/wk)/Phase 1|
1037348|NCT00724984|O2|Outcome|Mantle Cell Lymphoma/Phase II (Efficacy)|
1037349|NCT00724984|O1|Outcome|Follicular/Phase II (Efficacy)|
1037350|NCT00724984|O4|Outcome|Cohort 4(60 mg/m2, BID, 7days/wk)/Phase I|
1037351|NCT00724984|O3|Outcome|Cohort 3(45 mg/m2, BID, 7days/wk)/Phase I|
1037352|NCT00724984|O2|Outcome|Cohort 2(45 mg/m2, BID, 5days/wk)/Phase I|
1037353|NCT00724984|O1|Outcome|Cohort 1(30 mg/m2, BID, 5days/wk)/Phase I|
1037354|NCT00724984|E6|Reported Event|Mantle Cell Lymphoma/Phase II|
1037355|NCT00724984|E5|Reported Event|Follicular/Phase II|
1037356|NCT00724984|E4|Reported Event|Cohort 4(60 mg/m2,7days/wk)/Phase I|
1037357|NCT00724984|E3|Reported Event|Cohort 3(45 mg/m2, 7days/wk)/Phase I|
1037358|NCT00724984|E2|Reported Event|Cohort 2(45 mg/m2, 5days/wk)/Phase I|
1037359|NCT00724984|E1|Reported Event|Cohort 1(30 mg/m2, 5days/wk)/Phase I|
1037360|NCT00724958|B1|Baseline|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting who received at least one infliximab infusion.
1037361|NCT00724958|P1|Participant Flow|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
1037362|NCT00724958|O1|Outcome|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
1037364|NCT00724958|O1|Outcome|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
1037365|NCT00724958|O1|Outcome|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
1037366|NCT00724958|O1|Outcome|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
1037367|NCT00724958|O1|Outcome|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
1037368|NCT00724958|E1|Reported Event|Remicade|Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
1037369|NCT00724945|B1|Baseline|Overall|The reporting group for baseline characteristics includes all subjects that completed the study wearing contact lenses made from either senofilcon A or balafilcon A material. Excluded are 8 subjects that discontinued and 2 subjects dispensed lenses from outside study contact lens materials.
1037370|NCT00724945|P2|Participant Flow|Balafilcon A/Senofilcon A|balafilcon A multifocal contact lenses worn first/ senofilcon A multifocal contact lenses worn second
1037371|NCT00724945|P1|Participant Flow|Senofilcon A/Balafilcon A|senofilcon A multifocal contact lenses worn first, balafilcon A multifocal contact lenses worn second
1037372|NCT00724945|O2|Outcome|Balafilcon A|multifocal contact lens
1037373|NCT00724945|O1|Outcome|Senofilcon A|multifocal contact lens
1037374|NCT00724945|O2|Outcome|Balafilcon A|multifocal contact lens
1037375|NCT00724945|O1|Outcome|Senofilcon A|multifocal contact lens
1037376|NCT00724945|O2|Outcome|Balafilcon A|multifocal contact lens
1037377|NCT00724945|O1|Outcome|Senofilcon A|multifocal contact lens
1037378|NCT00724945|E2|Reported Event|Balafilcon A/Senofilcon A|balafilcon A multifocal contact lenses worn first/ senofilcon A multifocal contact lenses worn second
1037379|NCT00724945|E1|Reported Event|Senofilcon A/Balafilcon A|senofilcon A multifocal contact lenses worn first, balafilcon A multifocal contact lenses worn second
1037380|NCT00724932|B3|Baseline|Total|Total of all reporting groups
1037381|NCT00724932|B2|Baseline|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
1037382|NCT00724932|B1|Baseline|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037383|NCT00724932|P2|Participant Flow|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine: atropine) at reappearance of the second twitch (T2)
1037384|NCT00724932|P1|Participant Flow|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 Post Tetanic Count (PTC)
1037385|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
1037386|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037387|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
1037388|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037389|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
1037390|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037391|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
1037392|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037393|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
1037394|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037395|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
1037396|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037397|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
1037398|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037399|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
1037400|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037401|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
1037402|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037403|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
1037404|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037405|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
1037406|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037407|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
1037408|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037409|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
1037410|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037411|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
1037412|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037413|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
1037415|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
1037416|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037417|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
1037418|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037419|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
1037420|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037421|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
1037422|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037423|NCT00724932|O1|Outcome|Sugammadex Only|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037424|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
1037425|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037426|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
1037427|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037428|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
1037429|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037430|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
1037431|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037432|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
1037433|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037434|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
1037435|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037436|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
1037437|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037438|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
1037439|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037440|NCT00724932|O1|Outcome|Neostigmine Only|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
1037441|NCT00724932|O1|Outcome|Sugammadex Only|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037442|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
1037443|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037444|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
1037445|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037446|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
1037447|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037448|NCT00724932|O2|Outcome|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
1037449|NCT00724932|O1|Outcome|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037450|NCT00724932|E2|Reported Event|Neostigmine|Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine: atropine) at reappearance of T2
1037451|NCT00724932|E1|Reported Event|Sugammadex|Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC
1037452|NCT00724893|B3|Baseline|Total|Total of all reporting groups
1037453|NCT00724893|B2|Baseline|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037454|NCT00724893|B1|Baseline|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037455|NCT00724893|P2|Participant Flow|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037456|NCT00724893|P1|Participant Flow|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037457|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037458|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037668|NCT00724594|O3|Outcome|NAC Term Infants|Term infants treated with N-acetylcysteine
1037459|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037460|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037461|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037462|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037463|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037464|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037465|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037466|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037467|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037468|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037469|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037470|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037471|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037472|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037473|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037474|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037475|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037476|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037477|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037478|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037479|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037480|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037481|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037482|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037483|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037484|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037485|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037486|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037487|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037488|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037489|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037490|NCT00724893|O5|Outcome|>85 kg|Participants with weight >85 kg
1037491|NCT00724893|O4|Outcome|75 to <85 kg|Participants with weight 75 to <85 kg
1037492|NCT00724893|O3|Outcome|64 to <75 kg|Participants with weight 64 to <75 kg
1037493|NCT00724893|O2|Outcome|50 to <64 kg|Participants with weight 50 to <64 kg
1037494|NCT00724893|O1|Outcome|40 to <50 kg|Participants with weight 40 to <50 kg
1037495|NCT00724893|O3|Outcome|Viral Load Missing|Participants with viral load missing
1037496|NCT00724893|O2|Outcome|Viral Load Low|Participants with viral load xxxx
1037497|NCT00724893|O1|Outcome|Viral Load High|Participants with viral load xxxx
1037498|NCT00724893|O6|Outcome|Unknown Stage|Participants with unknown Fibrosis Stage
1037499|NCT00724893|O5|Outcome|Stage F4|Participants with Fibrosis Stage F4
1037500|NCT00724893|O4|Outcome|Stage F3|Participants with Fibrosis Stage F4
1037501|NCT00724893|O3|Outcome|Stage F2|Participants with Fibrosis Stage F2
1037502|NCT00724893|O2|Outcome|Stage F1|Participants with Fibrosis Stage F1
1037503|NCT00724893|O1|Outcome|Stage F0|Participants with Fibrosis Stage F0
1037504|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037505|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037506|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037507|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037508|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037509|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037510|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037511|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037512|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037513|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037514|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037515|NCT00724893|O2|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037516|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037517|NCT00724893|O1|Outcome|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037518|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037519|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037520|NCT00724893|O1|Outcome|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037669|NCT00724594|O2|Outcome|NAC Preterm Infants|Preterm infants treated with N-acetylcysteine
1053907|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
1037521|NCT00724893|E2|Reported Event|Stage 2 Participants|Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037522|NCT00724893|E1|Reported Event|Stage 1 Participants|Participants with chronic hepatitis C (CHC) receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
1037523|NCT00724867|B1|Baseline|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
1037524|NCT00724867|P1|Participant Flow|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
1037525|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
1037526|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
1037527|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
1037528|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
1037529|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
1037530|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
1037531|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
1037532|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
1037533|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
1037591|NCT00724815|O1|Outcome|NP101 Patch|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
1037592|NCT00724815|E2|Reported Event|Placebo Patch|The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
1037534|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
1037535|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
1037536|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
1037537|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
1037538|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
1037539|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
1037540|NCT00724867|O2|Outcome|Belimumab 10 mg/kg IV (Belimumab)|Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
1037541|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV (Placebo)|Participants, who had received placebo in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
1037542|NCT00724867|O2|Outcome|Belimumab 10 mg/kg IV (Belimumab)|Participants, who had received belimumab 1mg/kg or 10 mg/kg in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
1037543|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV (Placebo)|Participants, who had received placebo in study HGS1006-C1056, received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. The dosing was continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
1037544|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
1037545|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
1037593|NCT00724815|E1|Reported Event|NP101 Patch|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
1037594|NCT00724750|B3|Baseline|Total|Total of all reporting groups
1037670|NCT00724594|O1|Outcome|NAC Maternal|Mothers treated with N-acetylcysteine prior to delivery of infant
1037546|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
1037547|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
1037548|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
1037549|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
1037550|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
1037551|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
1037552|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
1037553|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
1037554|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
1037555|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
1037556|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
1037557|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
1037558|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1mg/kg or 10 mg/kg or placebo in study HGS1006-C1056 , received IV infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received SoC for systemic lupus erythematosus (SLE) during study participation.
1053908|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
1037559|NCT00724867|O1|Outcome|Belimumab 10 mg/kg IV|Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.
1037560|NCT00724867|E1|Reported Event|Belimumab 10 mg/kg IV|Belimumab 10 mg/kg IV every 28 days
1037561|NCT00724854|B3|Baseline|Total|Total of all reporting groups
1037562|NCT00724854|B2|Baseline|Co-infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
1037563|NCT00724854|B1|Baseline|Mono-infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
1037564|NCT00724854|P2|Participant Flow|Co-infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
1037565|NCT00724854|P1|Participant Flow|Mono-infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
1037566|NCT00724854|O2|Outcome|Co-infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
1037567|NCT00724854|O1|Outcome|Mono-infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
1037568|NCT00724854|O2|Outcome|Co-infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
1037569|NCT00724854|O1|Outcome|Mono-infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
1037570|NCT00724854|O2|Outcome|Co-infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
1037571|NCT00724854|O1|Outcome|Mono-infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
1037572|NCT00724854|O2|Outcome|Co-infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
1037573|NCT00724854|O1|Outcome|Mono-infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
1037574|NCT00724854|O2|Outcome|Co-infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
1037575|NCT00724854|O1|Outcome|Mono-infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
1037576|NCT00724854|E3|Reported Event|Not Evaluated|
1037577|NCT00724854|E2|Reported Event|Co-Infected With HCV and HIV|Participants co-infected with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
1037578|NCT00724854|E1|Reported Event|Mono-Infected With HCV|Participants infected with Hepatitis C Virus (HCV), received PegIntron plus Rebetol, administered in accordance with approved labeling.
1037579|NCT00724815|B3|Baseline|Total|Total of all reporting groups
1037580|NCT00724815|B2|Baseline|Placebo Patch|The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
1037581|NCT00724815|B1|Baseline|NP101 Patch|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
1037582|NCT00724815|P2|Participant Flow|Placebo Patch|The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
1037583|NCT00724815|P1|Participant Flow|NP101 Patch|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
1037584|NCT00724815|O2|Outcome|Placebo Patch|The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
1037585|NCT00724815|O1|Outcome|NP101 Patch|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
1037586|NCT00724815|O2|Outcome|Placebo Patch|The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
1037587|NCT00724815|O1|Outcome|NP101 Patch|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
1037588|NCT00724815|O2|Outcome|Placebo Patch|The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
1037589|NCT00724815|O1|Outcome|NP101 Patch|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
1037590|NCT00724815|O2|Outcome|Placebo Patch|The study placebo patch contained sodium chloride instead of sumatriptan which was delivered over 4 hours. Patients were asked to treat one migraine episode with moderate to severe headache pain.
1037595|NCT00724750|B2|Baseline|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.~Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
1037596|NCT00724750|B1|Baseline|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.~Gauze suction (G-SUC): Negative pressure wound therapy"
1037597|NCT00724750|P2|Participant Flow|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.~Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
1037598|NCT00724750|P1|Participant Flow|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.~Gauze suction (G-SUC): Negative pressure wound therapy"
1037599|NCT00724750|O2|Outcome|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.~Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
1037600|NCT00724750|O1|Outcome|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.~Gauze suction (G-SUC): Negative pressure wound therapy"
1037601|NCT00724750|O2|Outcome|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.~Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
1037602|NCT00724750|O1|Outcome|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.~Gauze suction (G-SUC): Negative pressure wound therapy"
1037603|NCT00724750|O2|Outcome|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.~Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
1037604|NCT00724750|O1|Outcome|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.~Gauze suction (G-SUC): Negative pressure wound therapy"
1037605|NCT00724750|O2|Outcome|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.~Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
1037606|NCT00724750|O1|Outcome|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.~Gauze suction (G-SUC): Negative pressure wound therapy"
1037607|NCT00724750|O2|Outcome|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.~Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
1037608|NCT00724750|O1|Outcome|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.~Gauze suction (G-SUC): Negative pressure wound therapy"
1037609|NCT00724750|O2|Outcome|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.~Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
1037610|NCT00724750|O1|Outcome|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.~Gauze suction (G-SUC): Negative pressure wound therapy"
1037611|NCT00724750|E2|Reported Event|Vacuum Assisted Closure|"Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours.~Vacuum Assisted Closure Device (VAC): Negative Pressure Wound Therapy"
1037612|NCT00724750|E1|Reported Event|G-SUC|"Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily.~Gauze suction (G-SUC): Negative pressure wound therapy"
1037613|NCT00724711|B3|Baseline|Total|Total of all reporting groups
1037614|NCT00724711|B2|Baseline|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
1037615|NCT00724711|B1|Baseline|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
1037616|NCT00724711|P2|Participant Flow|Abacavir (ABC) /Lamivudine (3TC) + PI/r (Ritonavir-boosted PI)|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
1037617|NCT00724711|P1|Participant Flow|FTC/TDF (Truvada [TVD]) + PI/r (Ritonavir-boosted PI Regimen)|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
1037618|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
1037619|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
1037620|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
1037621|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
1037622|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
1037657|NCT00724594|P3|Participant Flow|NAC Maternal|Mothers of infants treated with N-acetylcysteine
1037623|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
1037624|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
1037625|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
1037626|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
1037627|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
1037628|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
1037629|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
1037630|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
1037631|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
1037632|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
1037633|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
1037634|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
1037635|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
1037636|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
1037637|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
1037638|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
1037639|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
1037640|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
1037641|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
1037642|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
1037643|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
1037644|NCT00724711|O2|Outcome|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
1037645|NCT00724711|O1|Outcome|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
1037646|NCT00724711|E2|Reported Event|ABC/3TC + PI/r|Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
1037647|NCT00724711|E1|Reported Event|TVD + PI/r|Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada [TVD]) for 48 weeks. The participant's prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study.
1037648|NCT00724698|B1|Baseline|Desloratadine|Desloratadine 5 mg daily
1037649|NCT00724698|P1|Participant Flow|Desloratadine|Desloratadine 5 mg daily
1037650|NCT00724698|O1|Outcome|Desloratadine|Desloratadine 5 mg daily
1037651|NCT00724594|B5|Baseline|Total|Total of all reporting groups
1037652|NCT00724594|B4|Baseline|Control Maternal|Mothers of infants treated with saline
1037653|NCT00724594|B3|Baseline|NAC Maternal|Mothers of infants treated with N-acetylcysteine
1037654|NCT00724594|B2|Baseline|Control Infant|Infants treated with saline
1037655|NCT00724594|B1|Baseline|NAC Infant|Infants treated with N-acetylcysteine
1037656|NCT00724594|P4|Participant Flow|Control Maternal|Mothers of infants treated with saline
1037673|NCT00724594|O1|Outcome|NAC Maternal|Mothers treated with N-acetylcysteine prior to delivery of infant
1037674|NCT00724594|O3|Outcome|NAC Term Infants|Term infants treated with N-acetylcysteine
1037675|NCT00724594|O2|Outcome|NAC Preterm Infants|Preterm infants treated with N-acetylcysteine
1037676|NCT00724594|O1|Outcome|NAC Maternal|Mothers treated with N-acetylcysteine prior to delivery of infant
1037677|NCT00724594|E4|Reported Event|Control Maternal|Mothers of infants treated with saline
1037678|NCT00724594|E3|Reported Event|NAC Maternal|Mothers of infants treated with N-acetylcysteine
1037679|NCT00724594|E2|Reported Event|Control Infant|Infants treated with saline
1037680|NCT00724594|E1|Reported Event|NAC Infant|Infants treated with N-acetylcysteine
1037681|NCT00724568|B1|Baseline|Combination Drug Therapy|Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
1037682|NCT00724568|P2|Participant Flow|Phase II|Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
1037683|NCT00724568|P1|Participant Flow|Phase I|Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
1037684|NCT00724568|O1|Outcome|Combination Drug Therapy|Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
1037685|NCT00724568|O1|Outcome|Combination Drug Therapy|Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
1037686|NCT00724568|E1|Reported Event|Combination Drug Therapy|Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
1037687|NCT00724477|B1|Baseline|Subjects Treated With INEGY|Subjects suffering from primary hypercholesterolemia that were not adequately controlled by statins as a monotherapy, and were treated with INEGY. INEGY is composed of a combination of ezetimibe (10 mg) and simvastatin (20 or 40 mg). The dosage of the study treatment is one tablet per day ezetimibe/simvastatin (10 mg/20 mg or 10 mg/40 mg).
1037688|NCT00724477|P1|Participant Flow|Subjects Treated With INEGY|Subjects suffering from primary hypercholesterolemia that were not adequately controlled by statins as a monotherapy, and were treated with INEGY. INEGY is composed of a combination of ezetimibe (10 mg) and simvastatin (20 or 40 mg). The dosage of the study treatment is one tablet per day ezetimibe/simvastatin (10 mg/20 mg or 10 mg/40 mg).
1037689|NCT00724477|O1|Outcome|Subjects Treated With INEGY|Subjects suffering from primary hypercholesterolemia that were not adequately controlled by statins as a monotherapy, and were treated with INEGY. INEGY is composed of a combination of ezetimibe (10 mg) and simvastatin (20 or 40 mg). The dosage of the study treatment is one tablet per day ezetimibe/simvastatin (10 mg/20 mg or 10 mg/40 mg).
1037690|NCT00724477|E1|Reported Event|Subjects Treated With INEGY|Subjects suffering from primary hypercholesterolemia that were not adequately controlled by statins as a monotherapy, and were treated with INEGY. INEGY is composed of a combination of ezetimibe (10 mg) and simvastatin (20 or 40 mg). The dosage of the study treatment is one tablet per day ezetimibe/simvastatin (10 mg/20 mg or 10 mg/40 mg).
1037691|NCT00724464|B1|Baseline|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
1037692|NCT00724464|P1|Participant Flow|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
1037693|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with Chronic Hepatitis C (CHC) of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on Hepatitis C virus (HCV) genotype and viral load followed by a 24-week post-treatment follow-up.
1037694|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
1037695|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
1037886|NCT00723788|B1|Baseline|MRI of the Abdomen|All patients enrolled will receive an MRI of the abdomen with detailed views of the appendix.
1038977|NCT00721175|O2|Outcome|Plastic Stent|Plastic stent group
1037696|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
1037697|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
1037698|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
1037699|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
1037700|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
1037701|NCT00724464|O1|Outcome|Pegylated Interferon Alpha-2b and Ribavirin|Participants with Chronic Hepatitis C (CHC) of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on Hepatitis C virus (HCV) genotype and viral load followed by a 24-week post-treatment follow-up.
1037702|NCT00724464|E1|Reported Event|Pegylated Interferon Alpha-2b and Ribavirin|Participants with CHC of any genotype were treated with a standard treatment regimen of pegylated interferon alfa-2b and ribavirin. Each dose of pegylated interferon alfa-2b was administered as a subcutaneous injection calculated as 1.5 μg/kg once a week. Ribavirin was taken orally, twice daily, at a daily dose of 800 to 1200 mg. Therapy duration varied from 24 to 48 weeks depending on HCV genotype and viral load followed by a 24-week post-treatment follow-up.
1037703|NCT00724451|B1|Baseline|Participants With Chronic Hepatitis C (CHC)|Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
1037704|NCT00724451|P1|Participant Flow|Participants With Chronic Hepatitis C (CHC)|Peginterferon-naïve participants with chronic hepatitis C (CHC) seen in general clinical practice in Italy.
1037705|NCT00724451|O1|Outcome|Participants With Chronic Hepatitis C (CHC)|Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
1037706|NCT00724451|O1|Outcome|Participants With Chronic Hepatitis C (CHC)|Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
1037707|NCT00724451|O1|Outcome|Participants With Chronic Hepatitis C (CHC)|Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
1037708|NCT00724451|E1|Reported Event|Participants With Chronic Hepatitis C (CHC)|Peginterferon-naïve participants with CHC seen in general clinical practice in Italy.
1037709|NCT00724373|B1|Baseline|Participants With Genotype 1 Hepatitis C Virus Infection.|Participants with genotype 1 Hepatitis C Virus (HCV) infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months
1037710|NCT00724373|P1|Participant Flow|Participants With Genotype 1 Hepatitis C Virus Infection.|Participants with genotype 1 Hepatitis C Virus (HCV) infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months
1037711|NCT00724373|O1|Outcome|Participants With Genotype 1 Hepatitis C Virus Infection.|Participants with genotype 1 Hepatitis C Virus (HCV) infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months
1037712|NCT00724373|E1|Reported Event|Pegylated Interferon Alfa-2b and Ribavirin|
1037713|NCT00724347|B1|Baseline|Training Group|Hearing impaired subjects with bilateral, symmtrical sloping hearing losses who wore hearing aids
1037714|NCT00724347|P1|Participant Flow|Arm 1|PC-Based Consonant Discrimination Training: Subjects will receive adaptive training in consonant discrimination on PCs in their homes.
1037715|NCT00724347|O1|Outcome|Training Group|Hearing impaired subjects with bilateral, symmtrical sloping hearing losses who wore hearing aids
1037716|NCT00724347|E1|Reported Event|Arm 1|PC-Based Consonant Discrimination Training: Subjects will receive adaptive training in consonant discrimination on PCs in their homes.
1037717|NCT00724308|B3|Baseline|Total|Total of all reporting groups
1037718|NCT00724308|B2|Baseline|Arm 2|"Telephone Care Coordination with state Quitline: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) warm transfer to state Quitline for cessation counseling; and (4) follow-up at 2 and 6 months to check the patient's smoking status."
1037719|NCT00724308|B1|Baseline|Arm 1|Telephone Care Coordination with VA counselors: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from a VA counselor; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
1037882|NCT00723801|O2|Outcome|Subjects Randomized to Losartan|Losartan: Losartan 100mg PO QD
1053909|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
1037720|NCT00724308|P2|Participant Flow|Arm 2|"Telephone Care Coordination with state Quitline: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) warm transfer to state Quitline for cessation counseling; and (4) follow-up at 2 and 6 months to check the patient's smoking status."
1037721|NCT00724308|P1|Participant Flow|Arm 1|Telephone Care Coordination with VA counselors: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from a VA counselor; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
1037722|NCT00724308|O2|Outcome|Arm 2|"Telephone Care Coordination with state Quitline: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) warm transfer to state Quitline for cessation counseling; and (4) follow-up at 2 and 6 months to check the patient's smoking status."
1037723|NCT00724308|O1|Outcome|Arm 1|Telephone Care Coordination with VA counselors: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from a VA counselor; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
1037724|NCT00724308|E2|Reported Event|Arm 2|"Telephone Care Coordination with state Quitline: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) warm transfer to state Quitline for cessation counseling; and (4) follow-up at 2 and 6 months to check the patient's smoking status."
1037725|NCT00724308|E1|Reported Event|Arm 1|Telephone Care Coordination with VA counselors: The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from a VA counselor; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
1037726|NCT00724282|B1|Baseline|Eszopiclone or Placebo|"Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded.~Eszopiclone: Eszopiclone 3 mg by mouth daily at bedtime for 9 days~Placebo: Placebo by mouth daily at bedtime for 9 days"
1037727|NCT00724282|P1|Participant Flow|Eszopiclone or Placebo|"Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded.~Eszopiclone: Eszopiclone 3 mg by mouth daily at bedtime for 9 days~Placebo: Placebo by mouth daily at bedtime for 9 days"
1037728|NCT00724282|O1|Outcome|Eszopiclone or Placebo|"Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded.~Eszopiclone: Eszopiclone 3 mg by mouth daily at bedtime for 9 days~Placebo: Placebo by mouth daily at bedtime for 9 days"
1037729|NCT00724282|E1|Reported Event|Eszopiclone or Placebo|"Subjects receive either eszopiclone or placebo for 9 days, followed by 3 week washout, then crossover to opposite treatment. Treatment is double-blinded.~Eszopiclone: Eszopiclone 3 mg by mouth daily at bedtime for 9 days~Placebo: Placebo by mouth daily at bedtime for 9 days"
1037730|NCT00724243|B1|Baseline|Infliximab|Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
1037731|NCT00724243|P1|Participant Flow|Infliximab|Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
1037732|NCT00724243|O1|Outcome|Infliximab|Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
1037733|NCT00724243|O1|Outcome|Infliximab|Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
1037734|NCT00724243|E1|Reported Event|Infliximab|Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
1037735|NCT00724152|B6|Baseline|Total|Total of all reporting groups
1037736|NCT00724152|B5|Baseline|Period 2: Arm 3/Standard Care|Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment. 3 group randomization.
1037737|NCT00724152|B4|Baseline|Period 2: Arm 2/Tinnitus Education|Participants randomly assigned to this group received six weeks of tinnitus education. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 3 group randomization.
1037738|NCT00724152|B3|Baseline|Period 2: Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 3 grp randomize.
1037739|NCT00724152|B2|Baseline|Period 1: Arm 2/Tinnitus Education|Participants randomly assigned to this group received six weeks of tinnitus education. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 2 group randomization.
1037883|NCT00723801|O1|Outcome|Subjects Randomized to Atenolol|Atenolol: Atenolol 50mg PO QD
1037884|NCT00723801|E2|Reported Event|Subjects Randomized to Losartan|Losartan: Losartan 100mg PO QD
1037740|NCT00724152|B1|Baseline|Period 1: Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 2 grp randomize.
1037741|NCT00724152|P3|Participant Flow|Arm 3/Standard Care|Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment.
1037742|NCT00724152|P2|Participant Flow|Arm 2/Tinnitus Education|"Participants randomly assigned to this group received six weeks of tinnitus education.~Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources."
1037743|NCT00724152|P1|Participant Flow|Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources.
1037744|NCT00724152|O5|Outcome|Period 2: Arm 3/Standard Care|Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment. 3 group randomization.
1037745|NCT00724152|O4|Outcome|Period 2: Arm 2/Tinnitus Education|Participants randomly assigned to this group received six weeks of tinnitus education. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 3 group randomization.
1037746|NCT00724152|O3|Outcome|Period 2: Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 3 grp random.
1037747|NCT00724152|O2|Outcome|Period 1: Arm 2/Tinnitus Education|Participants randomly assigned to this group received six weeks of tinnitus education. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 2 group randomization.
1037748|NCT00724152|O1|Outcome|Period 1: Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 2 grp random.
1037749|NCT00724152|O5|Outcome|Period 2: Arm 3/Standard Care|Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment. 3 group randomization.
1037750|NCT00724152|O4|Outcome|Period 2: Arm 2/Tinnitus Education|Participants randomly assigned to this group received six weeks of tinnitus education. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 3 group randomization.
1037772|NCT00724009|B1|Baseline|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
1053910|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
1037751|NCT00724152|O3|Outcome|Period 2: Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 3 grp random.
1037752|NCT00724152|O2|Outcome|Period 1: Arm 2/Tinnitus Education|Participants randomly assigned to this group received six weeks of tinnitus education. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 2 group randomization.
1037753|NCT00724152|O1|Outcome|Period 1: Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. 2 grp random.
1037754|NCT00724152|E3|Reported Event|Arm 3/Standard Care|Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment.
1037755|NCT00724152|E2|Reported Event|Arm 2/Tinnitus Education|"Participants randomly assigned to this group received six weeks of tinnitus education.~Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources. Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment."
1037756|NCT00724152|E1|Reported Event|Arm 1/Cognitive Behavioral Therapy|Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources.
1037757|NCT00724126|B3|Baseline|Total|Total of all reporting groups
1037758|NCT00724126|B2|Baseline|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
1037759|NCT00724126|B1|Baseline|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
1037760|NCT00724126|P2|Participant Flow|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
1037761|NCT00724126|P1|Participant Flow|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
1037762|NCT00724126|O2|Outcome|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
1037763|NCT00724126|O1|Outcome|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
1037764|NCT00724126|O2|Outcome|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
1037765|NCT00724126|O1|Outcome|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
1037766|NCT00724126|E2|Reported Event|Rifaximin|Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
1037767|NCT00724126|E1|Reported Event|Placebo|Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
1037768|NCT00724061|B1|Baseline|PEG-IFN-alpha-2b + UV Therapy|Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB).
1037769|NCT00724061|P1|Participant Flow|PEG-IFN-alpha-2b + UV Therapy|Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB).
1037770|NCT00724061|O1|Outcome|PEG-IFN-alpha-2b + UV Therapy|Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB).
1037771|NCT00724061|E1|Reported Event|PEG-IFN-alpha-2b + UV Therapy|Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB).
1037784|NCT00723957|B2|Baseline|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
1037885|NCT00723801|E1|Reported Event|Subjects Randomized to Atenolol|Atenolol: Atenolol 50mg PO QD
1037773|NCT00724009|P1|Participant Flow|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
1037774|NCT00724009|O1|Outcome|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
1037775|NCT00724009|O1|Outcome|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
1037776|NCT00724009|O1|Outcome|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
1037777|NCT00724009|O1|Outcome|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
1037778|NCT00724009|O1|Outcome|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
1037779|NCT00724009|O1|Outcome|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
1037780|NCT00724009|O1|Outcome|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
1037781|NCT00724009|O1|Outcome|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
1037782|NCT00724009|E1|Reported Event|Clofarabine|"Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days~Clofarabine: Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line."
1037783|NCT00723957|B3|Baseline|Total|Total of all reporting groups
1053911|NCT00684307|O5|Outcome|VKA INR 2-3|
1037785|NCT00723957|B1|Baseline|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration–time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
1037786|NCT00723957|P2|Participant Flow|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
1037787|NCT00723957|P1|Participant Flow|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
1037788|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
1037789|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
1037790|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
1037791|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration–time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
1037792|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
1037793|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration–time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
1037794|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
1037795|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration–time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
1037796|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
1037797|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
1037798|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
1037799|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
1037800|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
1037801|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
1037802|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
1037803|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
1037804|NCT00723957|O2|Outcome|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
1037879|NCT00723801|P1|Participant Flow|Subjects Randomized to Atenolol|Atenolol: Atenolol 50mg PO QD
1037880|NCT00723801|O2|Outcome|Subjects Randomized to Losartan|Losartan: Losartan 100mg PO QD
1037805|NCT00723957|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
1037806|NCT00723957|E2|Reported Event|Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)|Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
1037807|NCT00723957|E1|Reported Event|Ixabepilone, 32 mg/m^2 + Carboplatin (AUC)|Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
1037808|NCT00723944|B3|Baseline|Total|Total of all reporting groups
1037809|NCT00723944|B2|Baseline|Osseotite Certain Implant|Patients with dental implant with internal connection and without the expanded, lateralized design at coronal portion
1037810|NCT00723944|B1|Baseline|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
1037811|NCT00723944|P2|Participant Flow|Osseotite Certain Implant|Patients with dental implant with internal connection and without the expanded, lateralized design at coronal portion
1037812|NCT00723944|P1|Participant Flow|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
1037813|NCT00723944|O2|Outcome|Osseotite Certain Implant|Patients with dental implant with internal connection and without the expanded, lateralized design at coronal portion
1037814|NCT00723944|O1|Outcome|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
1037815|NCT00723944|E2|Reported Event|Osseotite Certain Implant|Patients with dental implant with internal connection and without the expanded, lateralized design at coronal portion
1037816|NCT00723944|E1|Reported Event|Osseotite Certain Prevail Implant|Patients with dental implant with internal connection and expanded, lateralized design at coronal portion
1037817|NCT00723931|B1|Baseline|Pegintron/Pegintron Redipen Injection|Participants who have been diagnosed with chronic hepatitis C and treated with PegIntron according to local label.
1037818|NCT00723931|P1|Participant Flow|Pegintron/Pegintron Redipen Injection|Participants who have been diagnosed with chronic hepatitis C and treated with PegIntron according to local label.
1037819|NCT00723931|O1|Outcome|Pegintron/Pegintron Redipen Injection|Participants who have been diagnosed with chronic hepatitis C and treated with PegIntron according to local label.
1037820|NCT00723931|O1|Outcome|Pegintron/Pegintron Redipen Injection|Participants who have been diagnosed with chronic hepatitis C and treated with PegIntron according to local label.
1037821|NCT00723931|E1|Reported Event|Pegintron/Pegintron Redipen Injection|
1037822|NCT00723892|B3|Baseline|Total|Total of all reporting groups
1037823|NCT00723892|B2|Baseline|PegIntron/Rebetol Alone (no Psychotherapy)|Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
1037824|NCT00723892|B1|Baseline|PegIntron/Rebetol and Psychotherapy Support Program|Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
1037825|NCT00723892|P2|Participant Flow|PegIntron/Rebetol Alone (no Psychotherapy)|Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
1037826|NCT00723892|P1|Participant Flow|PegIntron/Rebetol and Psychotherapy Support Program|Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
1037827|NCT00723892|O2|Outcome|PegIntron/Rebetol Alone (no Psychotherapy|Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
1037828|NCT00723892|O1|Outcome|PegIntron/Rebetol and Psychotherapy Support Program|Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
1037829|NCT00723892|O2|Outcome|PegIntron/Rebetol Alone (no Psychotherapy)|Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
1037830|NCT00723892|O1|Outcome|PegIntron/Rebetol and Psychotherapy Support Program|Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.
1037831|NCT00723892|E1|Reported Event|All Enrolled Participants|
1037832|NCT00723840|B1|Baseline|Crohn's Disease Participants|"Participants with Crohn's Disease for at least 6~months, who have a Crohn's Disease Activity Index~(CDAI) score >= 150, seen at one of 25 gastroenterology centers spread across Italy. The CDAI score evaluates Crohn's disease symptoms - a score of 150 or below~indicates remission and a score above 450 indicates extremely severe disease."
1037833|NCT00723840|P1|Participant Flow|Crohn's Disease Participants|"Participants with Crohn's Disease for at least 6~months, who have a Crohn's Disease Activity Index~(CDAI) score >= 150, seen at one of 25 gastroenterology centers spread across Italy. The CDAI score evaluates Crohn's disease symptoms - a score of 150 or below~indicates remission and a score above 450 indicates extremely severe disease."
1037834|NCT00723840|O4|Outcome|18 Months|QoL scores per participant at 18 months
1037835|NCT00723840|O3|Outcome|12 Months|QoL scores per participant at 12 months
1037836|NCT00723840|O2|Outcome|6 Months|QoL scores per participant at 6 months
1037837|NCT00723840|O1|Outcome|Baseline|QoL scores per participant at baseline
1037838|NCT00723840|O4|Outcome|18 Months|Costs per participant at 18 months in Euros
1037839|NCT00723840|O3|Outcome|12 Months|Costs per participant at 12 months in Euros
1037840|NCT00723840|O2|Outcome|6 Months|Costs per participant at 6 months in Euros
1037841|NCT00723840|O1|Outcome|Baseline|Costs per participant at baseline in Euros
1037842|NCT00723840|E1|Reported Event|Crohn's Disease Participants|"Participants with Crohn's Disease for at least 6~months, who have a Crohn's Disease Activity Index~(CDAI) score >= 150, seen at one of 25 gastroenterology centers spread across Italy. The CDAI score evaluates Crohn's disease symptoms - a score of 150 or below~indicates remission and a score above 450 indicates extremely severe disease."
1037881|NCT00723801|O1|Outcome|Subjects Randomized to Atenolol|Atenolol: Atenolol 50mg PO QD
1037843|NCT00723827|B1|Baseline|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).~Temozolomide : Administration of temozolomide based on the product labeling.~Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
1037844|NCT00723827|P1|Participant Flow|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).~Temozolomide : Administration of temozolomide based on the product labeling.~Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
1037845|NCT00723827|O1|Outcome|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).~Temozolomide : Administration of temozolomide based on the product labeling.~Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
1037846|NCT00723827|O1|Outcome|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).~Temozolomide : Administration of temozolomide based on the product labeling.~Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
1037847|NCT00723827|O1|Outcome|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).~Temozolomide : Administration of temozolomide based on the product labeling.~Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
1037848|NCT00723827|O1|Outcome|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).~Temozolomide : Administration of temozolomide based on the product labeling.~Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
1037849|NCT00723827|O1|Outcome|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).~Temozolomide : Administration of temozolomide based on the product labeling.~Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
1037850|NCT00723827|E1|Reported Event|All Participants|"Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).~Temozolomide : Administration of temozolomide based on the product labeling.~Radiotherapy : Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme."
1037851|NCT00722800|B3|Baseline|Total|Total of all reporting groups
1037852|NCT00722800|B2|Baseline|Placebo Tablets|Placebo tablet once a day for 6 months
1037853|NCT00722800|B1|Baseline|Drospirenone and Ethinyl Estradiol (YAZ)|drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
1037854|NCT00722800|P2|Participant Flow|Placebo Tablets|Placebo tablet once a day for 6 months
1037855|NCT00722800|P1|Participant Flow|Drospirenone and Ethinyl Estradiol (YAZ)|drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
1037856|NCT00722800|O2|Outcome|Placebo Tablets|Placebo tablet once a day for 6 months
1037857|NCT00722800|O1|Outcome|Drospirenone and Ethinyl Estradiol (YAZ)|drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
1037858|NCT00722800|O2|Outcome|Placebo Tablets|Placebo tablet once a day for 6 months
1037859|NCT00722800|O1|Outcome|Drospirenone and Ethinyl Estradiol (YAZ)|drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
1037860|NCT00722800|O2|Outcome|Placebo Tablets|Placebo tablet once a day for 6 months
1037861|NCT00722800|O1|Outcome|Drospirenone and Ethinyl Estradiol (YAZ)|drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
1037862|NCT00722800|E2|Reported Event|Placebo Tablets|Placebo tablet once a day for 6 months
1037863|NCT00722800|E1|Reported Event|Drospirenone and Ethinyl Estradiol (YAZ)|drospirenone and ethinyl estradiol (YAZ) once a day for 6 months
1037864|NCT00722761|B3|Baseline|Total|Total of all reporting groups
1037865|NCT00722761|B2|Baseline|Placebo Tablet|Placebo tablet once a day
1037866|NCT00722761|B1|Baseline|Drosperinone and Ethinyl Estradiol|Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
1037867|NCT00722761|P2|Participant Flow|Placebo Tablet|Placebo tablet once a day
1037868|NCT00722761|P1|Participant Flow|Drosperinone and Ethinyl Estradiol|Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
1037869|NCT00722761|O2|Outcome|Placebo Tablet|Placebo tablet once a day
1037870|NCT00722761|O1|Outcome|Drosperinone and Ethinyl Estradiol|Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
1037871|NCT00722761|O2|Outcome|Placebo Tablet|Placebo tablet once a day
1037872|NCT00722761|O1|Outcome|Drosperinone and Ethinyl Estradiol|Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
1037873|NCT00722761|E2|Reported Event|Placebo Tablet|Placebo tablet once a day
1037874|NCT00722761|E1|Reported Event|Drosperinone and Ethinyl Estradiol|Drospirenone (3mg) and Ethinyl estradiol (0.02mg) (YAZ)tablet once a day
1037875|NCT00723801|B3|Baseline|Total|Total of all reporting groups
1037876|NCT00723801|B2|Baseline|Subjects Randomized to Losartan|Losartan: Losartan 100mg PO QD
1037877|NCT00723801|B1|Baseline|Subjects Randomized to Atenolol|Atenolol: Atenolol 50mg PO QD
1037878|NCT00723801|P2|Participant Flow|Subjects Randomized to Losartan|Losartan: Losartan 100mg PO QD
1037887|NCT00723788|P1|Participant Flow|MRI of the Abdomen|All patients enrolled will receive an MRI of the abdomen with detailed views of the appendix.
1037888|NCT00723788|O3|Outcome|CT of the Abdomen|All patients enrolled received an MRI followed in some cases by computed tomography.
1037889|NCT00723788|O2|Outcome|US of the Abdomen|All patients enrolled received an MRI followed in some cases by ultrasund.
1037890|NCT00723788|O1|Outcome|MRI of the Abdomen|All patients enrolled will receive an MRI of the abdomen with detailed views of the appendix.
1037891|NCT00723788|E1|Reported Event|MRI of the Abdomen|All patients enrolled will receive an MRI of the abdomen with detailed views of the appendix.
1037892|NCT00723749|B1|Baseline|Suboxone|Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
1037893|NCT00723749|P1|Participant Flow|Suboxone|Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
1037894|NCT00723749|O1|Outcome|Suboxone|Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
1037895|NCT00723749|O1|Outcome|Suboxone|Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
1037896|NCT00723749|O1|Outcome|Suboxone|Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
1037897|NCT00723749|O1|Outcome|Suboxone|Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
1037898|NCT00723749|E1|Reported Event|Suboxone|Patients for whom a drug dependence therapy with SUBOXONE® is planned and indicated, and who have already been pre-treated with SUBUTEX®, or another maintenance drug for at least 6 months.
1037899|NCT00723736|B1|Baseline|Aerius® Syrup|Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria
1037900|NCT00723736|P1|Participant Flow|Aerius® Syrup|Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria
1037901|NCT00723736|O1|Outcome|Aerius® Syrup|Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria
1037902|NCT00723736|E1|Reported Event|Aerius® Syrup|Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria
1037903|NCT00723710|B1|Baseline|Intron A|The recommended regimen included an induction treatment of 5 consecutive days per week for 4 weeks as a 20-minute intravenous (iv) infusion at a dose of 20 MIU/m^2. The induction treatment was followed by a maintenance treatment of 3 times per week for 48 weeks as a subcutaneous (sc) injection at a dose of 10 MIU/m^2. Therapy was administered for a total of one year unless the disease progressed or the treatment led to recurrent unmanageable serious adverse effects.
1037904|NCT00723710|P1|Participant Flow|Intron A|The recommended regimen included an induction treatment of 5 consecutive days per week for 4 weeks as a 20-minute intravenous (iv) infusion at a dose of 20 million international units per square meter (MIU/m^2). The induction treatment was followed by a maintenance treatment of 3 times per week for 48 weeks as a subcutaneous (sc) injection at a dose of 10 MIU/m^2. Therapy was administered for a total of one year unless the disease progressed or the treatment led to recurrent unmanageable serious adverse effects.
1037905|NCT00723710|O1|Outcome|Intron A|The recommended regimen included an induction treatment of 5 consecutive days per week for 4 weeks as a 20-minute intravenous (iv) infusion at a dose of 20 MIU/m^2. The induction treatment was followed by a maintenance treatment of 3 times per week for 48 weeks as a subcutaneous (sc) injection at a dose of 10 MIU/m^2. Therapy was administered for a total of one year unless the disease progressed or the treatment led to recurrent unmanageable serious adverse effects.
1037906|NCT00723710|E1|Reported Event|Intron-A|
1037907|NCT00723697|B1|Baseline|Patients|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
1037908|NCT00723697|P1|Participant Flow|Patients|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
1037909|NCT00723697|O1|Outcome|Patients|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
1037910|NCT00723697|O3|Outcome|Patients at 12 Month Visit|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
1037911|NCT00723697|O2|Outcome|Patients at 6 Month Visit|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
1037912|NCT00723697|O1|Outcome|Patients at First Visit|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
1037913|NCT00723697|O1|Outcome|Patients|Patients addicted to opiates and requiring replacement treatment. Patients in this non-interventional study were prescribed treatment as per usual clinical practice.
1037914|NCT00723697|E1|Reported Event|Patients|
1037915|NCT00723645|B1|Baseline|PEG IFN Alfa-2b + RBV|Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
1037916|NCT00723645|P1|Participant Flow|PEG IFN Alfa-2b + RBV|Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
1037958|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
1038268|NCT00723021|O2|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
1037917|NCT00723645|O1|Outcome|PEG IFN Alfa-2b + RBV|Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
1037918|NCT00723645|O1|Outcome|PEG IFN Alfa-2b + RBV|Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
1037919|NCT00723645|E1|Reported Event|PEG IFN Alfa-2b + RBV|Adult participants with chronic hepatitis C virus (HCV) who were treated for the first time with pegylated interferon alfa-2b plus ribavirin and achieved end-of-treatment response prior to the study. Participants received no treatment on this study.
1037920|NCT00723632|B1|Baseline|Peginterferon Alfa-2b and Ribavirin|Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants <65 kg, 1000 mg/day for participants >65 to <85 kg, and 1200 mg/day for participants >=85 kg. Treatment was administered for 48 weeks to participants with HCV genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.
1037921|NCT00723632|P1|Participant Flow|Peginterferon Alfa-2b and Ribavirin|Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants <65 kg, 1000 mg/day for participants >65 to <85 kg, and 1200 mg/day for participants >=85 kg. Treatment was administered for 48 weeks to participants with hepatitis C virus (HCV) genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.
1037922|NCT00723632|O1|Outcome|Peginterferon Alfa-2b and Ribavirin|Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants <65 kg, 1000 mg/day for participants >65 to <85 kg, and 1200 mg/day for participants >=85 kg. Treatment was administered for 48 weeks to participants with HCV genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.
1037923|NCT00723632|O1|Outcome|Peginterferon Alfa-2b and Ribavirin|Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants <65 kg, 1000 mg/day for participants >65 to <85 kg, and 1200 mg/day for participants >=85 kg. Treatment was administered for 48 weeks to participants with HCV genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.
1037924|NCT00723632|O1|Outcome|Peginterferon Alfa-2b and Ribavirin|Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants <65 kg, 1000 mg/day for participants >65 to <85 kg, and 1200 mg/day for participants >=85 kg. Treatment was administered for 48 weeks to participants with HCV genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.
1037925|NCT00723632|E1|Reported Event|Peginterferon Alfa-2b and Ribavirin|Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants <65 kg, 1000 mg/day for participants >65 to <85 kg, and 1200 mg/day for participants >=85 kg. Treatment was administered for 48 weeks to participants with HCV genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.
1037926|NCT00723606|B3|Baseline|Total|Total of all reporting groups
1037927|NCT00723606|B2|Baseline|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
1037928|NCT00723606|B1|Baseline|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
1037929|NCT00723606|P2|Participant Flow|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
1037930|NCT00723606|P1|Participant Flow|Ziprasidone|An initial intramuscular (IM) injection of ziprasidone 10 or 20 milligram (mg). Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours possible treatment.
1037931|NCT00723606|O2|Outcome|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
1037932|NCT00723606|O1|Outcome|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
1037933|NCT00723606|O2|Outcome|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
1037934|NCT00723606|O1|Outcome|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
1037935|NCT00723606|O2|Outcome|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
1037936|NCT00723606|O1|Outcome|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
1037937|NCT00723606|O2|Outcome|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
1037938|NCT00723606|O1|Outcome|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
1037959|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
1037939|NCT00723606|O2|Outcome|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
1037940|NCT00723606|O1|Outcome|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
1037941|NCT00723606|O2|Outcome|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
1037942|NCT00723606|O1|Outcome|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
1037943|NCT00723606|E2|Reported Event|Haloperidol|An initial IM injection of haloperidol 5 mg. Following, 5 mg haloperidol could have been repeated every 4 to 8 hours to a maximum of 20 mg of haloperidol in 24 hours, depending on clinical need. The total IM treatment was continued for 72 hours.
1037944|NCT00723606|E1|Reported Event|Ziprasidone|An initial IM injection of ziprasidone 10 or 20 mg. Additional doses could have been administered according to clinical need (the total daily parenteral dose could not have exceeded 40 mg IM) for a total of 72 hours of possible treatment.
1037945|NCT00723580|B1|Baseline|Actigraphic (Activity Count) Measurement of Sleep and Activity|Actigraphic measurements obtained by attaching an actigraphic watch device to the child's non-dominant wrist obtain measurements that occur every thirty seconds for a duration of approximately 21 days. These measurements reflect treatment condition sleep characteristics where sleep is indicated by activity counts below 40. Three 21 day actigraphic measurement periods occurred with the initial measurement occurring through baseline period and the period in which the child's pharmacological treatment was initiated. The second and third, 21 day periods of Actigraphic measurement occurred at 22 and 23 months from baseline. Five treatment conditions during the measurement periods including 1. baseline no medication 2. risperidone .25 mg at bedtime for 7 days (q.h.s.) 3. risperidone twice daily (b.i.d.) 4. risperidone .25 mg three times a day (t.i.d.) and 5. risperidone .50 mg three times a day (t.i.d.)
1037946|NCT00723580|P1|Participant Flow|Actigraphic (Activity Count) Measurement of Sleep and Activity|Actigraphic measurements obtained by attaching an actigraphic watch device to the child's non-dominant wrist obtain measurements that occur every thirty seconds for a duration of approximately 21 days. These measurements reflect treatment condition sleep characteristics where sleep is indicated by activity counts below 40. Three 21 day actigraphic measurement periods occurred with the initial measurement occurring through baseline period and the period in which the child's pharmacological treatment was initiated. The second and third, 21 day periods of Actigraphic measurement occurred at 22 and 23 months from baseline. Five treatment conditions during the measurement periods including 1. baseline no medication 2. risperidone .25 mg at bedtime for 7 days (q.h.s.) 3. risperidone twice daily (b.i.d.) 4. risperidone .25 mg three times a day (t.i.d.) and 5. risperidone .50 mg three times a day (t.i.d.)
1037947|NCT00723580|O1|Outcome|Actigraphic (Activity Count) Measurement of Sleep and Activity|Actigraphic measurements obtained by attaching an actigraphic watch device to the child's non-dominant wrist obtain measurements that occur every thirty seconds for a duration of approximately 21 days. These measurements reflect treatment condition sleep characteristics where sleep is indicated by activity counts below 40. Three 21 day actigraphic measurement periods occurred with the initial measurement occurring through baseline period and the period in which the child's pharmacological treatment was initiated. The second and third, 21 day periods of Actigraphic measurement occurred at 22 and 23 months from baseline. Five treatment conditions during the measurement periods including 1. baseline no medication 2. risperidone .25 mg at bedtime for 7 days (q.h.s.) 3. risperidone twice daily (b.i.d.) 4. risperidone .25 mg three times a day (t.i.d.) and 5. risperidone .50 mg three times a day (t.i.d.)
1037948|NCT00723580|E1|Reported Event|Actigraphic (Activity Count) Measurement of Sleep and Activity|Actigraphic measurements obtained by attaching an actigraphic watch device to the child's non-dominant wrist obtain measurements that occur every thirty seconds for a duration of approximately 21 days. These measurements reflect treatment condition sleep characteristics where sleep is indicated by activity counts below 40. Three 21 day actigraphic measurement periods occurred with the initial measurement occurring through baseline period and the period in which the child's pharmacological treatment was initiated. The second and third, 21 day periods of Actigraphic measurement occurred at 22 and 23 months from baseline. Five treatment conditions during the measurement periods including 1. baseline no medication 2. risperidone .25 mg at bedtime for 7 days (q.h.s.) 3. risperidone twice daily (b.i.d.) 4. risperidone .25 mg three times a day (t.i.d.) and 5. risperidone .50 mg three times a day (t.i.d.)
1037949|NCT00723554|B1|Baseline|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
1037950|NCT00723554|P1|Participant Flow|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
1037951|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
1037952|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
1037953|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
1037954|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
1037955|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
1037956|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
1037957|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
1038936|NCT00721227|O2|Outcome|Greater Curve|Reduction Gastroplasty by Gastric Plication on Greater Curve
1037960|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
1037961|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
1037962|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
1037963|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
1037964|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
1037965|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
1037966|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
1037967|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
1037968|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
1037969|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
1037970|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
1037971|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
1037972|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
1037973|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
1037974|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
1037975|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
1037976|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
1037977|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
1037978|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
1037979|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
1037980|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
1037981|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
1037982|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
1037983|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
1037984|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
1037985|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
1037986|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
1037987|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
1037988|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
1037989|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
1037990|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
1037991|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
1037992|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
1037993|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
1037994|NCT00723554|O1|Outcome|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
1037995|NCT00723554|E1|Reported Event|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
1037996|NCT00723528|B4|Baseline|Total|Total of all reporting groups
1037997|NCT00723528|B3|Baseline|Ustekinumab 90 mg (CP)|Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
1037998|NCT00723528|B2|Baseline|Ustekinumab 45 mg (CP)|Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
1037999|NCT00723528|B1|Baseline|Placebo (CP)|Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
1038000|NCT00723528|P7|Participant Flow|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52. Participants were then followed until Week 72.
1038001|NCT00723528|P6|Participant Flow|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52. Participants were then followed until Week 72.
1038002|NCT00723528|P5|Participant Flow|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
1038003|NCT00723528|P4|Participant Flow|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
1038004|NCT00723528|P3|Participant Flow|Ustekinumab 90 mg (CP)|Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
1038005|NCT00723528|P2|Participant Flow|Ustekinumab 45 mg (CP)|Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
1038006|NCT00723528|P1|Participant Flow|Placebo (CP)|Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
1038007|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
1038008|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
1038009|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
1038010|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
1038011|NCT00723528|O3|Outcome|Ustekinumab 90 mg (CP)|Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
1038012|NCT00723528|O2|Outcome|Ustekinumab 45 mg (CP)|Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
1038013|NCT00723528|O1|Outcome|Placebo (CP)|Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
1038014|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
1038015|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
1038016|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
1038017|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
1038018|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
1038019|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
1038020|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
1038021|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
1038022|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
1053912|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
1038023|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
1038024|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
1038025|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
1038026|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
1038027|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
1038028|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
1038029|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
1038030|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
1038031|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
1038032|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
1038033|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
1038034|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
1038035|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
1038036|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
1038037|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
1038038|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
1038039|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
1038040|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
1038041|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
1038042|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
1038043|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
1038124|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
1038044|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
1038045|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
1038046|NCT00723528|O4|Outcome|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
1038047|NCT00723528|O3|Outcome|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
1038048|NCT00723528|O2|Outcome|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
1038049|NCT00723528|O1|Outcome|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
1038050|NCT00723528|O3|Outcome|Ustekinumab 90 mg (CP)|Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
1038051|NCT00723528|O2|Outcome|Ustekinumab 45 mg (CP)|Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
1038052|NCT00723528|O1|Outcome|Placebo (CP)|Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
1038053|NCT00723528|O3|Outcome|Ustekinumab 90 mg (CP)|Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
1038054|NCT00723528|O2|Outcome|Ustekinumab 45 mg (CP)|Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
1038055|NCT00723528|O1|Outcome|Placebo (CP)|Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
1038056|NCT00723528|E7|Reported Event|Ustekinumab 90 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
1038057|NCT00723528|E6|Reported Event|Ustekinumab 45 mg (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.
1038058|NCT00723528|E5|Reported Event|Placebo B (After CP)|After the controlled period (i.e., during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.
1038059|NCT00723528|E4|Reported Event|Placebo A (After CP)|After the controlled period (that is [i.e.], during the active drug treatment period [Weeks 12-64]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.
1038060|NCT00723528|E3|Reported Event|Ustekinumab 90 mg (CP)|Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
1038061|NCT00723528|E2|Reported Event|Ustekinumab 45 mg (CP)|Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).
1038062|NCT00723528|E1|Reported Event|Placebo (CP)|Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).
1038063|NCT00723489|B5|Baseline|Total|Total of all reporting groups
1038064|NCT00723489|B4|Baseline|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
1038065|NCT00723489|B3|Baseline|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
1038066|NCT00723489|B2|Baseline|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
1038067|NCT00723489|B1|Baseline|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
1038068|NCT00723489|P4|Participant Flow|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
1038211|NCT00723177|O1|Outcome|Placebo|"This group will receive placebo AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
1038069|NCT00723489|P3|Participant Flow|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
1038070|NCT00723489|P2|Participant Flow|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
1038071|NCT00723489|P1|Participant Flow|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
1038072|NCT00723489|O2|Outcome|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
1038073|NCT00723489|O1|Outcome|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
1038074|NCT00723489|O2|Outcome|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
1038075|NCT00723489|O1|Outcome|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
1038076|NCT00723489|O2|Outcome|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
1038077|NCT00723489|O1|Outcome|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
1038078|NCT00723489|O2|Outcome|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
1038079|NCT00723489|O1|Outcome|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
1038080|NCT00723489|O2|Outcome|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
1038081|NCT00723489|O1|Outcome|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
1038082|NCT00723489|O2|Outcome|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
1038083|NCT00723489|O1|Outcome|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
1038084|NCT00723489|O2|Outcome|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
1038085|NCT00723489|O1|Outcome|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
1038086|NCT00723489|O2|Outcome|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
1038087|NCT00723489|O1|Outcome|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
1038212|NCT00723177|E3|Reported Event|High-dose AV411|"This group will receive a high dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
1053913|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
1038088|NCT00723489|O2|Outcome|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
1038089|NCT00723489|O1|Outcome|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
1038090|NCT00723489|O2|Outcome|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
1038091|NCT00723489|O1|Outcome|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
1038092|NCT00723489|E4|Reported Event|YFV-17D TC - (AD)|Participants classified as atopic dermatitis (AD) and defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
1038093|NCT00723489|E3|Reported Event|YFV-17D TC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received one dose of YFV-17D vaccine by transcutaneous administration in the left deltoid and one dose of placebo by subcutaneous administration in the right deltoid.
1038094|NCT00723489|E2|Reported Event|YFV-17D SC - (AD)|Participants classified as atopic dermatitis (AD) defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of YFV-17D by subcutaneous administration in the right deltoid and one dose of placebo by transcutaneous administration in the left deltoid.
1038095|NCT00723489|E1|Reported Event|YFV-17D SC - (Non-AD)|Healthy volunteer participants who did not have atopic dermatitis defined by Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria and received a 0.5 mL dose of the Yellow Fever vaccine (YFV-17D) by subcutaneous (SC) administration in the right deltoid and one dose of placebo by transcutaneous (TC) administration in the left deltoid.
1038096|NCT00723450|B3|Baseline|Total|Total of all reporting groups
1038097|NCT00723450|B2|Baseline|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
1038098|NCT00723450|B1|Baseline|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
1038099|NCT00723450|P3|Participant Flow|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
1038100|NCT00723450|P2|Participant Flow|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
1038101|NCT00723450|P1|Participant Flow|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
1038102|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
1038103|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
1038104|NCT00723450|O1|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
1038105|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
1038106|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
1038143|NCT00723294|O1|Outcome|Treatment (Cryoablation)|A cryoprobe is inserted percutaneously under ultrasound guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively. Patients undergo surgical resection and sentinel lymph node biopsy and/or axillary dissection within 28 days after completion of cryoablation.
1038425|NCT00722371|O6|Outcome|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
1038107|NCT00723450|O1|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
1038108|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
1038109|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
1038110|NCT00723450|O1|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
1038111|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
1038112|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
1038113|NCT00723450|O1|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
1038114|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
1038115|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
1038116|NCT00723450|O1|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
1038117|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
1038118|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
1038119|NCT00723450|O1|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
1038120|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
1038121|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
1038122|NCT00723450|O1|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
1038123|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
1038937|NCT00721227|O1|Outcome|Anterior Curve|Reduction Gastroplasty by Gastric Plication on Anterior Curve
1038125|NCT00723450|O1|Outcome|LTG: Open-Label Phase|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of : 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
1038126|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
1038127|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
1038128|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
1038129|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
1038130|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
1038131|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
1038132|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
1038133|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
1038134|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
1038135|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
1038136|NCT00723450|O2|Outcome|Lamotrigine|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
1038137|NCT00723450|O1|Outcome|Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
1038138|NCT00723450|E3|Reported Event|Randomized and Double-blind Taper Phases: LTG|Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks. Participants completing the Randomized Phase entered Double-Blind Taper and Follow-up Phase. The Taper and Follow-up Phase may last up to 4 weeks, dependent on the dose of LTG the participant received during the Randomized Phase.
1038139|NCT00723450|E2|Reported Event|Randomized and Double-blind Taper Phases: Placebo|Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks. Participants completing the Randomized Phase entered Double-Blind Taper and Follow-up Phase. The Taper and Follow-up Phase may last up to 4 weeks. The participant received Placebo during this Phase.
1038140|NCT00723450|E1|Reported Event|Open-Label and Open-Label Taper Phases: LTG|Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of : 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks. Participants discontinuing from the study during the Open-Label Phase entered an open Taper and Follow-up Phase.The Taper and Follow-up Phase may last up to 4 weeks, dependent on the dose of LTG the participant received during the Open-Label Phase.
1038141|NCT00723294|B1|Baseline|Treatment (Cryoablation)|A cryoprobe is inserted percutaneously under ultrasound guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively. Patients undergo surgical resection and sentinel lymph node biopsy and/or axillary dissection within 28 days after completion of cryoablation.
1038142|NCT00723294|P1|Participant Flow|Treatment (Cryoablation)|A cryoprobe is inserted percutaneously under ultrasound guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively. Patients undergo surgical resection and sentinel lymph node biopsy and/or axillary dissection within 28 days after completion of cryoablation.
1038208|NCT00723177|O1|Outcome|Placebo|"This group will receive placebo AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
1038970|NCT00721175|P1|Participant Flow|SEMS|self-expandable metal stent group
1038144|NCT00723294|O1|Outcome|Treatment (Cryoablation)|A cryoprobe is inserted percutaneously under ultrasound guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively. Patients undergo surgical resection and sentinel lymph node biopsy and/or axillary dissection within 28 days after completion of cryoablation.
1038145|NCT00723294|E1|Reported Event|Treatment (Cryoablation)|A cryoprobe is inserted percutaneously under ultrasound guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively. Patients undergo surgical resection and sentinel lymph node biopsy and/or axillary dissection within 28 days after completion of cryoablation.
1038146|NCT00723255|B1|Baseline|Bevacizumab Plus Temsirolimus|Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
1038147|NCT00723255|P1|Participant Flow|Bevacizumab Plus Temsirolimus|Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
1038148|NCT00723255|O2|Outcome|Grade 3|Patients with grade 3 tumors (patients with missing grade excluded, n=7)
1038149|NCT00723255|O1|Outcome|Grade 1,2|Patients with grade 1-2 tumors (patients with missing grade excluded, n=7)
1038150|NCT00723255|O2|Outcome|Grade 3|Patients with grade 3 tumors (patients with missing grade excluded, n=7)
1038151|NCT00723255|O1|Outcome|Grade 1,2|Patients with grade 1-2 tumors (patients with missing grade excluded, n=7)
1038152|NCT00723255|O2|Outcome|Other Histologic Types|Patients with other histologic types, including benign (not otherwise specified) (n=1), unspecified adenocarcinoma (n=1), clear cell carcinoma (n=2), mucinous adenocarcinoma (n=1), mixed epithelial carcinoma (n=5), undifferentiated carcinoma (n=1), serous adenocarcinoma (n=4)
1038153|NCT00723255|O1|Outcome|Endometrioid Adenocarcinoma|Patients with endometrioid adenocarcinoma
1038154|NCT00723255|O2|Outcome|Other Histologic Types|Patients with other histologic types, including benign (not otherwise specified) (n=1), unspecified adenocarcinoma (n=1), clear cell carcinoma (n=2), mucinous adenocarcinoma (n=1), mixed epithelial carcinoma (n=5), undifferentiated carcinoma (n=1), serous adenocarcinoma (n=4)
1038155|NCT00723255|O1|Outcome|Endometrioid Adenocarcinoma|Patients with endometrioid adenocarcinoma
1038156|NCT00723255|O2|Outcome|Performance Status 1,2|Patients with performance status 1 or 2 Performance Status 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light house work Performance Status 2: Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours
1038157|NCT00723255|O1|Outcome|Performance Status 0|Patients with performance status 0 Performance Status 0: Fully active, able to carry on all pre-disease performance without restriction
1038158|NCT00723255|O2|Outcome|Performance Status 1,2|Patients with performance status 1 or 2 Performance Status 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light house work Performance Status 2: Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours
1038159|NCT00723255|O1|Outcome|Performance Status 0|Patients with performance status 0 Performance Status 0: Fully active, able to carry on all pre-disease performance without restriction
1038160|NCT00723255|O1|Outcome|Bevacizumab Plus Temsirolimus|Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
1038161|NCT00723255|O1|Outcome|Bevacizumab Plus Temsirolimus|Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
1038162|NCT00723255|O1|Outcome|Bevacizumab Plus Temsirolimus|Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
1038163|NCT00723255|O1|Outcome|Bevacizumab Plus Temsirolimus|Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
1038164|NCT00723255|E1|Reported Event|Bevacizumab Plus Temsirolimus|Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy
1038165|NCT00723229|B3|Baseline|Total|Total of all reporting groups
1038166|NCT00723229|B2|Baseline|Acyclovir 400 mg Twice Daily|
1038167|NCT00723229|B1|Baseline|No Medication|
1038168|NCT00723229|P2|Participant Flow|Acyclovir 400 mg Twice Daily First, Followed by no Medication|Acyclovir 400 mg twice daily for 4 weeks, then 1 week washout, followed by no medication for 4 weeks
1038169|NCT00723229|P1|Participant Flow|No Medication First, Then Standard-dose Acyclovir|No medication for 4 weeks, then 1 week washout, followed by acyclovir 400 mg twice daily for 4 weeks
1038170|NCT00723229|O2|Outcome|Acyclovir 400 mg Twice Daily|
1038171|NCT00723229|O1|Outcome|No Medication|
1038172|NCT00723229|O2|Outcome|Acyclovir 400 mg Twice Daily|
1038173|NCT00723229|O1|Outcome|No Medication|
1038174|NCT00723229|O2|Outcome|Acyclovir 400 mg Twice Daily|
1038175|NCT00723229|O1|Outcome|No Medication|
1038176|NCT00723229|O2|Outcome|Acyclovir 400 mg Twice Daily|
1038177|NCT00723229|O1|Outcome|No Medication|
1038178|NCT00723229|E2|Reported Event|Acyclovir 400 mg Twice Daily|
1038179|NCT00723229|E1|Reported Event|No Medication|
1038180|NCT00723203|B1|Baseline|Treatment (Panobinostat)|"Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~panobinostat: 40 mg Monday, Wednesday and Friday of every week in a 28 day cycle~gene expression analysis: Day 1 and day 28 samples~reverse transcriptase-polymerase chain reaction: Day 1 and day 28 samples~laboratory biomarker analysis: Day 1 and day 28 samples"
1038209|NCT00723177|O3|Outcome|High-dose AV411|"This group will receive a high dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
1038210|NCT00723177|O2|Outcome|Low-dose AV411|"This group will receive a low dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
1038181|NCT00723203|P1|Participant Flow|Treatment (Panobinostat)|"Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~panobinostat: 40 mg Monday, Wednesday and Friday of every week in a 28 day cycle~gene expression analysis: Day 1 and day 28 samples~reverse transcriptase-polymerase chain reaction: Day 1 and day 28 samples~laboratory biomarker analysis: Day 1 and day 28 samples"
1038182|NCT00723203|O1|Outcome|Treatment (Panobinostat)|"Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~panobinostat: 40 mg Monday, Wednesday and Friday of every week in a 28 day cycle~gene expression analysis: Day 1 and day 28 samples~reverse transcriptase-polymerase chain reaction: Day 1 and day 28 samples~laboratory biomarker analysis: Day 1 and day 28 samples"
1038183|NCT00723203|E1|Reported Event|Treatment (Panobinostat)|"Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~panobinostat: 40 mg Monday, Wednesday and Friday of every week in a 28 day cycle~gene expression analysis: Day 1 and day 28 samples~reverse transcriptase-polymerase chain reaction: Day 1 and day 28 samples~laboratory biomarker analysis: Day 1 and day 28 samples"
1038184|NCT00723190|B1|Baseline|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
1038185|NCT00723190|P1|Participant Flow|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
1038186|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
1038187|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
1038188|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
1038189|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
1038190|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
1038191|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
1038192|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
1038193|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
1038194|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
1038195|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
1038196|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
1038197|NCT00723190|O1|Outcome|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
1038198|NCT00723190|E1|Reported Event|KAPVAY (CLONICEL)|One tablet (0.1 mg) for 1 week; At Week 2, one additional 0.1 mg tablet; At Week 3, one additional 0.1 mg tablet; At Week 4, one last 0.1 mg tablet bringing the total dose to a maximum of 0.4 mg/day (0.2 mg twice daily)
1038199|NCT00723177|B4|Baseline|Total|Total of all reporting groups
1038200|NCT00723177|B3|Baseline|High-dose AV411|"This group will receive a high dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
1038201|NCT00723177|B2|Baseline|Low-dose AV411|"This group will receive a low dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
1038202|NCT00723177|B1|Baseline|Placebo|"This group will receive placebo AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
1038203|NCT00723177|P3|Participant Flow|High-dose AV411|"This group will receive a high dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally twice a day for two consecutive weeks"
1038204|NCT00723177|P2|Participant Flow|Low-dose AV411|"This group will receive a low dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally twice a day for two consecutive weeks"
1038205|NCT00723177|P1|Participant Flow|Placebo|"This group received placebo AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally twice a day for two consecutive weeks"
1038206|NCT00723177|O3|Outcome|High-dose AV411|"This group will receive a high dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
1038207|NCT00723177|O2|Outcome|Low-dose AV411|"This group will receive a low dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
1038971|NCT00721175|O2|Outcome|Plastic Stent|Plastic stent group
1038213|NCT00723177|E2|Reported Event|Low-dose AV411|"This group will receive a low dose of AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
1038214|NCT00723177|E1|Reported Event|Placebo|"This group will receive placebo AV411~AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks"
1038215|NCT00723125|B3|Baseline|Total|Total of all reporting groups
1038216|NCT00723125|B2|Baseline|Cohort 2|"Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10) Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles followed by Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks~Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)"
1038217|NCT00723125|B1|Baseline|Cohort 1|"Avastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks~Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)"
1038218|NCT00723125|P2|Participant Flow|Cohort 2|"Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10) Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles followed by Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks~Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)"
1038219|NCT00723125|P1|Participant Flow|Cohort 1|"Avastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks~Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)"
1038220|NCT00723125|O2|Outcome|Cohort 2|"Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10) Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles followed by Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks~Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)"
1038221|NCT00723125|O1|Outcome|Cohort 1|"Avastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks~Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)"
1038222|NCT00723125|E6|Reported Event|Cohort 2 Adjuvant Post Surgery|Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks
1038223|NCT00723125|E5|Reported Event|Cohort 1 Adjuvant Post Surgery|Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks
1038224|NCT00723125|E4|Reported Event|Cohort 2 DDAC|Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles
1038225|NCT00723125|E3|Reported Event|Cohort 1 DDAC|Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles
1038226|NCT00723125|E2|Reported Event|Cohort 2 Neo-adjuvant|Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)
1038227|NCT00723125|E1|Reported Event|Cohort 1 Neo-adjuvant|Avastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10
1038228|NCT00723073|B3|Baseline|Total|Total of all reporting groups
1038229|NCT00723073|B2|Baseline|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
1038230|NCT00723073|B1|Baseline|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
1038231|NCT00723073|P2|Participant Flow|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
1038232|NCT00723073|P1|Participant Flow|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
1038233|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
1038234|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
1038235|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
1038236|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
1038237|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
1038238|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
1038239|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
1038240|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
1038241|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
1038242|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
1038243|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
1038244|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
1038245|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
1038246|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
1038247|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
1038248|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
1038249|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
1038250|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
1038251|NCT00723073|O2|Outcome|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
1038252|NCT00723073|O1|Outcome|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
1038253|NCT00723073|E2|Reported Event|Micafungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
1038254|NCT00723073|E1|Reported Event|Caspofungin Arm|All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
1038255|NCT00723021|B1|Baseline|All Participants|Participants receiving any of the 5 treatments (PF-04191834 30 mg, PF-04191834 100 mg, PF-04191834 2000 mg, Zileuton CR 1200 mg and Placebo) in a randomized fashion first
1038256|NCT00723021|P5|Participant Flow|Treatment Sequence 5|Zileuton CR 1200 mg/PF-04191834 2000 mg/Placebo/PF-04191834 100 mg/PF-04191834 30 mg
1038257|NCT00723021|P4|Participant Flow|Treatment Sequence 4|PF-04191834 30 mg/Placebo/PF-04191834 100 mg/Zileuton CR 1200 mg/PF-04191834 2000 mg
1038258|NCT00723021|P3|Participant Flow|Treatment Sequence 3|PF-04191834 2000 mg/PF-04191834 100 mg/Zileuton CR 1200 mg/PF-04191834 30 mg/Placebo
1038259|NCT00723021|P2|Participant Flow|Treatment Sequence 2|PF-04191834 100 mg/PF-04191834 30 mg/PF-04191834 2000 mg/Placebo/Zileuton CR 1200 mg
1038260|NCT00723021|P1|Participant Flow|Treatment Sequence 1|Placebo/Zileuton CR 1200 mg/PF-04191834 30 mg/PF-04191834 2000 mg/PF-04191834 100 mg
1038261|NCT00723021|O3|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
1038262|NCT00723021|O2|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
1038263|NCT00723021|O1|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
1038264|NCT00723021|O3|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
1038265|NCT00723021|O2|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
1038266|NCT00723021|O1|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
1038267|NCT00723021|O3|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
1038972|NCT00721175|O1|Outcome|SEMS|SEMS (Self-expandable metal stent group)
1038269|NCT00723021|O1|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
1038270|NCT00723021|O3|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
1038271|NCT00723021|O2|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
1038272|NCT00723021|O1|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
1038273|NCT00723021|O3|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
1038274|NCT00723021|O2|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
1038275|NCT00723021|O1|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
1038276|NCT00723021|O5|Outcome|Zileuton CR 1200 mg|Paticipants received a single oral dose of zileuton CR 1200 mg (2 x 600 mg tablets) in any treatment period
1038277|NCT00723021|O4|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
1038278|NCT00723021|O3|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
1038279|NCT00723021|O2|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
1038280|NCT00723021|O1|Outcome|Placebo|Participants received a single oral dose of placebo for zileuton CR tablets or placebo for PF-04191834 oral aqueous dispersion in any treatment period
1038281|NCT00723021|O5|Outcome|Zileuton CR 1200 mg|Each subject received zileuton CR 1200 mg, 2x600 mg tablets, single dose + placebo oral dispersion, single dose
1038282|NCT00723021|O4|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
1038283|NCT00723021|O3|Outcome|PF-04191834 100 mg|Each subject received PF-04191834 100 mg, single dose, oral disersion + 2 x placebo tablets, single dose
1038284|NCT00723021|O2|Outcome|PF-04191834 30 mg|Each subject received PF-04191834 30 mg, single dose, oral dispersion + 2 x placebo tablets
1038285|NCT00723021|O1|Outcome|Placebo|Each subject received 2 x placebo tablets ( for zileuton 600 mg tablets) + placebo oral dispersion (for PF-04191834), single dose
1038286|NCT00723021|O5|Outcome|Zileuton CR 1200 mg|Paticipants received a single oral dose of zileuton CR 1200 mg (2 x 600 mg tablets) in any treatment period
1038287|NCT00723021|O4|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
1038288|NCT00723021|O3|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
1038289|NCT00723021|O2|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
1038290|NCT00723021|O1|Outcome|Placebo|Participants received a single oral dose of placebo for zileuton CR tablets or placebo for PF-04191834 oral aqueous dispersion in any treatment period
1038291|NCT00723021|O5|Outcome|Zileuton CR 1200 mg|Each subject received zileuton CR 1200 mg, 2x600 mg tablets, single dose + placebo oral dispersion, single dose
1038292|NCT00723021|O4|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
1038293|NCT00723021|O3|Outcome|PF-04191834 100 mg|Each subject received PF-04191834 100 mg, single dose, oral disersion + 2 x placebo tablets, single dose
1038294|NCT00723021|O2|Outcome|PF-04191834 30 mg|Each subject received PF-04191834 30 mg, single dose, oral dispersion + 2 x placebo tablets
1038295|NCT00723021|O1|Outcome|Placebo|Each subject received 2 x placebo tablets ( for zileuton 600 mg tablets) + placebo oral dispersion (for PF-04191834), single dose
1038296|NCT00723021|O5|Outcome|Zileuton CR 1200 mg|Paticipants received a single oral dose of zileuton CR 1200 mg (2 x 600 mg tablets) in any treatment period
1038297|NCT00723021|O4|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
1038298|NCT00723021|O3|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
1038299|NCT00723021|O2|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
1038300|NCT00723021|O1|Outcome|Placebo|Participants received a single oral dose of placebo for zileuton CR tablets or placebo for PF-04191834 oral aqueous dispersion in any treatment period
1038301|NCT00723021|O5|Outcome|Zileuton CR 1200 mg|Paticipants received a single oral dose of zileuton CR 1200 mg (2 x 600 mg tablets) in any treatment period
1038302|NCT00723021|O4|Outcome|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
1038303|NCT00723021|O3|Outcome|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
1038304|NCT00723021|O2|Outcome|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
1038305|NCT00723021|O1|Outcome|Placebo|Participants received a single oral dose of placebo for zileuton CR tablets or placebo for PF-04191834 oral aqueous dispersion in any treatment period
1038306|NCT00723021|E5|Reported Event|Zileuton CR 1200 mg|Paticipants received single oral dose of zileuton CR1200 mg (2 x 600 mg tablets) in any treatment period
1038307|NCT00723021|E4|Reported Event|PF-04191834 2000 mg|Participants received a single oral dose of PF-04191834 2000 mg in any treatment period
1038308|NCT00723021|E3|Reported Event|PF-04191834 100 mg|Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period
1038309|NCT00723021|E2|Reported Event|PF-04191834 30 mg|Participants received a single oral dose of PF-04191834 30 mg in any treatment period
1038310|NCT00723021|E1|Reported Event|Placebo|Participants received single oral dose of placebo for zileuton CR tablets or placebo for PF-04191834 oral aqueous dispersion in any treatment period
1038311|NCT00723008|B3|Baseline|Total|Total of all reporting groups
1038358|NCT00722566|B2|Baseline|VELCADE Intravenous|VELCADE 1.3 mg/m^2 administered by intravenous infusion on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
1038973|NCT00721175|O2|Outcome|Plastic Stent|Plastic stent group
1038360|NCT00722566|P2|Participant Flow|VELCADE Intravenous|VELCADE 1.3 mg/m^2 administered by intravenous infusion on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
1038312|NCT00723008|B2|Baseline|B: Sham/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to no stimulation (0/6)will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
1038313|NCT00723008|B1|Baseline|A: Active/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
1038314|NCT00723008|P2|Participant Flow|B: Sham/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to no stimulation (0/6)will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
1038315|NCT00723008|P1|Participant Flow|A: Active/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
1038316|NCT00723008|O2|Outcome|B: Sham/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to no stimulation (0/6)will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
1038317|NCT00723008|O1|Outcome|A: Active/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
1038318|NCT00723008|O4|Outcome|Group B: AFTER Treatment|Subjects receiving 4 weeks of Sham CES treatment followed by 4 weeks of open label sensate treatment
1038319|NCT00723008|O3|Outcome|Group B: BEFORE Treatment|Subjects receiving 4 weeks of Sham CES treatment followed by 4 weeks of open label sensate treatment
1038320|NCT00723008|O2|Outcome|Group A: AFTER CES Treatment|Subjects receiving 4 weeks of sub-sensation CES followed by 4 weeks of open label sensate treatment
1038321|NCT00723008|O1|Outcome|Group A: BEFORE CES Treatment|Subjects receiving 4 weeks of sub-sensation CES followed by 4 weeks of open label sensate treatment
1038322|NCT00723008|O4|Outcome|Group B: AFTER Sham or CES Treatment|Subjects receiving 4 weeks of Sham CES treatment followed by 4 weeks of open label sensate treatment
1038323|NCT00723008|O3|Outcome|Group B: BEFORE Sham or CES Treatment|Subjects receiving 4 weeks of Sham CES treatment followed by 4 weeks of open label sensate treatment
1038324|NCT00723008|O2|Outcome|Group A: AFTER CES Treatment|Subjects receiving 4 weeks of sub-sensation CES followed by 4 weeks of open label sensate treatment
1038325|NCT00723008|O1|Outcome|Group A: BEFORE CES Treatment|Subjects receiving 4 weeks of sub-sensation CES followed by 4 weeks of open label sensate treatment
1038326|NCT00723008|O2|Outcome|B: Sham/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to no stimulation (0/6)will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
1038327|NCT00723008|O1|Outcome|A: Active/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
1038328|NCT00723008|O2|Outcome|B: Sham/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to no stimulation (0/6)will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
1038359|NCT00722566|B1|Baseline|VELCADE Subcutaneous|VELCADE 1.3 mg/m^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
1038329|NCT00723008|O1|Outcome|A: Active/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
1038330|NCT00723008|O2|Outcome|B: Sham/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to no stimulation (0/6)will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
1038331|NCT00723008|O1|Outcome|A: Active/Unblinded|"Upon randomization, a double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) will be applied to the earlobes of the subject for one hour per day for 5 days per week for 4 weeks; after the blinded period is completed the patient will wear a different Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6). Report of pain, anxiety will be assessed before and after each daily session during the 8 week period.~Alpha Stim 100 (Cranial Electrotherapy Stimulation) : cranial electrical stimulation 100 microamps"
1038332|NCT00723008|E4|Reported Event|Group B: Unblinded Phase|Subjects Previously receiving sham device, now using active Alpha Stim device with settings at the patient's preference (1 to 6/6), one hour per day for 5 days per week for 4 weeks.
1038333|NCT00723008|E3|Reported Event|Group B: Blinded Phase|Subjects receiving sham CES treatment for 1 hour daily for 4 weeks.
1038334|NCT00723008|E2|Reported Event|Group A: Unblinded Phase|Subjects using Alpha Stim device that has not been blinded for one hour per day for 5 days per week for 4 weeks, with settings at the patient's preference (1 to 6/6).
1038335|NCT00723008|E1|Reported Event|Group A: Blinded Phase|Subjects receiving double blinded Alpha Stim 100 device preset to the lowest effective setting (1/6) for one hour daily.
1038336|NCT00722865|B1|Baseline|Avastin (Bevacizumab)|"single-arm, open-label~Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles."
1038337|NCT00722865|P1|Participant Flow|Avastin (Bevacizumab)|"single-arm, open-label~Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles."
1038338|NCT00722865|O1|Outcome|Avastin (Bevacizumab)|"single-arm, open-label~Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles."
1038339|NCT00722865|O1|Outcome|Avastin (Bevacizumab)|"single-arm, open-label~Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles."
1038340|NCT00722865|O1|Outcome|Avastin (Bevacizumab)|"single-arm, open-label~Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles."
1038341|NCT00722865|O1|Outcome|Avastin (Bevacizumab)|"single-arm, open-label~Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles."
1038342|NCT00722865|O1|Outcome|Avastin (Bevacizumab)|"single-arm, open-label~Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles."
1038343|NCT00722865|E1|Reported Event|Avastin (Bevacizumab)|"single-arm, open-label~Avastin: Given intravenously along with standard chemotherapy (Adriamycin, Bleomycin, Vinblastine and Dacarbazine) on days 1 and 15 of a 28-day cycle for a total of 6 planned cycles."
1038344|NCT00722722|B4|Baseline|Total|Total of all reporting groups
1038345|NCT00722722|B3|Baseline|32 Dose Group|"32 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
1038346|NCT00722722|B2|Baseline|16 Dose Group|"16 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
1038347|NCT00722722|B1|Baseline|4 Dose Group|"4 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
1038348|NCT00722722|P3|Participant Flow|32 Dose Group|"32 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
1038349|NCT00722722|P2|Participant Flow|16 Dose Group|"16 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
1038350|NCT00722722|P1|Participant Flow|4 Dose Group|"4 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
1038351|NCT00722722|O3|Outcome|32 Dose Group|"32 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
1038352|NCT00722722|O2|Outcome|16 Dose Group|"16 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
1038353|NCT00722722|O1|Outcome|4 Dose Group|"4 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
1038354|NCT00722722|E3|Reported Event|32 Dose Group|"32 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
1038355|NCT00722722|E2|Reported Event|16 Dose Group|"16 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
1038356|NCT00722722|E1|Reported Event|4 Dose Group|"4 doses of bortezomib (1.3mg/m^2 of body surface area)~Bortezomib: Velcade given in four-dose cycles intravenously (through a vein)."
1038357|NCT00722566|B3|Baseline|Total|Total of all reporting groups
1038361|NCT00722566|P1|Participant Flow|VELCADE Subcutaneous|VELCADE 1.3 mg/m^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
1038362|NCT00722566|O2|Outcome|VELCADE Intravenous|VELCADE 1.3 mg/m^2 administered by intravenous infusion on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
1038363|NCT00722566|O1|Outcome|VELCADE Subcutaneous|VELCADE 1.3 mg/m^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
1038364|NCT00722566|O2|Outcome|VELCADE Intravenous|VELCADE 1.3 mg/m^2 administered by intravenous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
1038365|NCT00722566|O1|Outcome|VELCADE Subcutaneuous|VELCADE 1.3 mg/m^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
1038366|NCT00722566|E2|Reported Event|VELCADE Intravenous|VELCADE 1.3 mg/m^2 administered by intravenous infusion on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
1038367|NCT00722566|E1|Reported Event|VELCADE Subcutaneous|VELCADE 1.3 mg/m^2 administered by subcutaneous injection on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles.
1038368|NCT00722553|B1|Baseline|Full Population|Population consists of all patients who received at least 1 dose of pralatrexate. Pralatrexate was administered on days 1 and 15 of a 4-week cycle as an intravenous (IV) push over 3-5 minutes via a peripheral IV line containing normal saline at an initial dose of 190 mg/m2. These patients received a 1 mg intramuscular injection of Vitamin B12 within 10 weeks of enrollment and every 8-10 weeks throughout the study, and for at least 30 days after the last dose of pralatrexate. These patients were also administered 1-1.25 mg of Folic Acid orally for at least 7 days prior to enrollment, throughout the study and for at least 30 days after the last dose of pralatrexate.
1038369|NCT00722553|P1|Participant Flow|Full Population|Population consists of all patients who received at least 1 dose of pralatrexate. Pralatrexate was administered on days 1 and 15 of a 4-week cycle as an intravenous (IV) push over 3-5 minutes via a peripheral IV line containing normal saline at an initial dose of 190 mg/m2. These patients received a 1 mg intramuscular injection of Vitamin B12 within 10 weeks of enrollment and every 8-10 weeks throughout the study, and for at least 30 days after the last dose of pralatrexate. These patients were also administered 1-1.25 mg of Folic Acid orally for at least 7 days prior to enrollment, throughout the study and for at least 30 days after the last dose of pralatrexate.
1038370|NCT00722553|O1|Outcome|Evaluable Population|All patients who received at least 1 dose of pralatrexate, had histologically confirmed TCC (> 50% TCC in tumor) of the urinary bladder, and had measurable disease at baseline.
1038371|NCT00722553|O1|Outcome|Evaluable Population|All patients who received at least 1 dose of pralatrexate, had histologically confirmed TCC (> 50% TCC in tumor) of the urinary bladder, and had measurable disease at baseline.
1038372|NCT00722553|O1|Outcome|Evaluable Population|All patients who received at least 1 dose of pralatrexate, had histologically confirmed TCC (> 50% TCC in tumor) of the urinary bladder, and had measurable disease at baseline.
1038373|NCT00722553|O1|Outcome|Evaluable Patients|All patients who received at least 1 dose of pralatrexate, had histologically confirmed TCC (> 50% TCC in tumor) of the urinary bladder, and had measurable disease at baseline.
1038374|NCT00722553|O1|Outcome|Evaluable Population|All patients who received at least 1 dose of pralatrexate, had histologically confirmed transitional cell carcinoma (TCC) (> 50% TCC in tumor) of the urinary bladder, and had measurable disease at baseline.
1038375|NCT00722553|E1|Reported Event|Full Population|Population consists of all patients who received at least 1 dose of pralatrexate. Pralatrexate was administered on days 1 and 15 of a 4-week cycle as an intravenous (IV) push over 3-5 minutes via a peripheral IV line containing normal saline at an initial dose of 190 mg/m2. These patients received a 1 mg intramuscular injection of Vitamin B12 within 10 weeks of enrollment and every 8-10 weeks throughout the study, and for at least 30 days after the last dose of pralatrexate. These patients were also administered 1-1.25 mg of Folic Acid orally for at least 7 days prior to enrollment, throughout the study and for at least 30 days after the last dose of pralatrexate.
1038376|NCT00722436|B3|Baseline|Total|Total of all reporting groups
1038377|NCT00722436|B2|Baseline|Placebo|"Saline~saline: Placebo"
1038378|NCT00722436|B1|Baseline|Tranexamic Acid|"Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)~Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr~Patients are randomized to TXA or saline. This group is the TXA group."
1038379|NCT00722436|P2|Participant Flow|Placebo|"Saline~saline: Placebo"
1038380|NCT00722436|P1|Participant Flow|Tranexamic Acid|"Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)~Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr~Patients are randomized to TXA or saline. This group is the TXA group."
1038381|NCT00722436|O2|Outcome|Placebo|"Saline~saline: Placebo"
1038382|NCT00722436|O1|Outcome|Tranexamic Acid|"Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)~Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr~Patients are randomized to TXA or saline. This group is the TXA group."
1038383|NCT00722436|O2|Outcome|Placebo|"Saline~saline: Placebo"
1038384|NCT00722436|O1|Outcome|Tranexamic Acid|"Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)~Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr~Patients are randomized to TXA or saline. This group is the TXA group."
1038385|NCT00722436|O2|Outcome|Placebo|"Saline~saline: Placebo"
1038386|NCT00722436|O1|Outcome|Tranexamic Acid|"Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)~Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr~Patients are randomized to TXA or saline. This group is the TXA group."
1038387|NCT00722436|O2|Outcome|Placebo|"Saline~saline: Placebo"
1038388|NCT00722436|O1|Outcome|Tranexamic Acid|"Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)~Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr~Patients are randomized to TXA or saline. This group is the TXA group."
1038389|NCT00722436|E2|Reported Event|Placebo|"Saline~saline: Placebo"
1038390|NCT00722436|E1|Reported Event|Tranexamic Acid|"Tranexamic acid (100 mg/kg load, 10 mg/kg/hr)~Tranexamic acid: 100 mg/kg load, then 10 mg/kg/hr~Patients are randomized to TXA or saline. This group is the TXA group."
1038391|NCT00722423|B3|Baseline|Total|Total of all reporting groups
1038392|NCT00722423|B2|Baseline|Usucal Care Model|
1038423|NCT00722371|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
1038424|NCT00722371|O7|Outcome|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
1038426|NCT00722371|O5|Outcome|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
1038393|NCT00722423|B1|Baseline|Integrated Care Model|Integrated care model: The integrated care intervention follows a manualized protocol consisting of a series of brief intervention tailored to the patients' main barriers to treatment along with a case management approach in which the integrated care mental health provider actively tracks each patients progress through the evaluation and treatment process. The integrated care mental health provider can be a clinical nurse specialist, psychologist, or licensed clinical social worker that has experience and training in the provision of psychiatric and SUD interventions. They will receive additional training on the integrated care protocol. Data will be collected at baseline, pre-treatment, and post-treatment intervals.
1038394|NCT00722423|P2|Participant Flow|Usual Care Model|Patients randomized to usual care (UC) received “standard of care” required for HCV patients consistent with current VA treatment guidelines and clinic structures.
1038395|NCT00722423|P1|Participant Flow|Integrated Care Model|Patients randomized to Integrated Care (IC) received care delivered according to a manualized protocol by a mid-level mental health provider (MHP) located within each HCV clinic. The protocol included brief psychological interventions and case management provided in collaboration with clinic physicians, nurses, and other mental health providers. The MHP evaluated study participants and provided ongoing interventions designed to treat specific mental health problems. The MHP also facilitated a complete treatment evaluation, encouraged the initiation of antiviral treatment, and served as a regular contact and case manager.
1038396|NCT00722423|O2|Outcome|Usual Care Model|Patients randomized to usual care (UC) received “standard of care” required for HCV patients consistent with current VA treatment guidelines and clinic structures.
1038397|NCT00722423|O1|Outcome|Integrated Care Model|Patients randomized to Integrated Care (IC) received care delivered according to a manualized protocol by a mid-level mental health provider (MHP) located within each HCV clinic. The protocol included brief psychological interventions and case management provided in collaboration with clinic physicians, nurses, and other mental health providers. The MHP evaluated study participants and provided ongoing interventions designed to treat specific mental health problems. The MHP also facilitated a complete treatment evaluation, encouraged the initiation of antiviral treatment, and served as a regular contact and case manager.
1038398|NCT00722423|O2|Outcome|Usual Care Model|"usual care~Patients receive care as usual in their HCV clinic. This care does not include the co-located mental health provider."
1038399|NCT00722423|O1|Outcome|Integrated Care Model|"integrated care~Integrated care model: The integrated care intervention follows a manualized protocol consisting of a series of brief intervention tailored to the patients' main barriers to treatment along with a case management approach in which the integrated care mental health provider actively tracks each patients progress through the evaluation and treatment process. The integrated care mental health provider can be a clinical nurse specialist, psychologist, or licensed clinical social worker that has experience and training in the provision of psychiatric and SUD interventions. They will receive additional training on the integrated care protocol. Data will be collected at baseline, pre-treatment, and post-treatment intervals."
1038400|NCT00722423|E2|Reported Event|Usual Care Model|Patients randomized to usual care (UC) received “standard of care” required for HCV patients consistent with current VA treatment guidelines and clinic structures.
1038401|NCT00722423|E1|Reported Event|Integrated Care Model|Patients randomized to Integrated Care (IC) received care delivered according to a manualized protocol by a mid-level mental health provider (MHP) located within each HCV clinic. The protocol included brief psychological interventions and case management provided in collaboration with clinic physicians, nurses, and other mental health providers. The MHP evaluated study participants and provided ongoing interventions designed to treat specific mental health problems. The MHP also facilitated a complete treatment evaluation, encouraged the initiation of antiviral treatment, and served as a regular contact and case manager.
1038402|NCT00722371|B8|Baseline|Total|Total of all reporting groups
1038403|NCT00722371|B7|Baseline|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
1038404|NCT00722371|B6|Baseline|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
1038405|NCT00722371|B5|Baseline|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
1038406|NCT00722371|B4|Baseline|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
1038407|NCT00722371|B3|Baseline|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
1038408|NCT00722371|B2|Baseline|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
1038409|NCT00722371|B1|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
1038410|NCT00722371|P7|Participant Flow|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
1038411|NCT00722371|P6|Participant Flow|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
1038412|NCT00722371|P5|Participant Flow|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
1038413|NCT00722371|P4|Participant Flow|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
1038414|NCT00722371|P3|Participant Flow|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
1038415|NCT00722371|P2|Participant Flow|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
1038416|NCT00722371|P1|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
1038417|NCT00722371|O7|Outcome|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
1038418|NCT00722371|O6|Outcome|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
1038419|NCT00722371|O5|Outcome|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
1038420|NCT00722371|O4|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
1038421|NCT00722371|O3|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
1038422|NCT00722371|O2|Outcome|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
1038427|NCT00722371|O4|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
1038428|NCT00722371|O3|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
1038429|NCT00722371|O2|Outcome|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
1038430|NCT00722371|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
1038431|NCT00722371|O7|Outcome|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
1038432|NCT00722371|O6|Outcome|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
1038433|NCT00722371|O5|Outcome|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
1038434|NCT00722371|O4|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
1038435|NCT00722371|O3|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
1038436|NCT00722371|O2|Outcome|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
1038437|NCT00722371|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
1038438|NCT00722371|O7|Outcome|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
1038439|NCT00722371|O6|Outcome|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
1038440|NCT00722371|O5|Outcome|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
1038441|NCT00722371|O4|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
1038442|NCT00722371|O3|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
1038443|NCT00722371|O2|Outcome|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
1038444|NCT00722371|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
1038445|NCT00722371|O7|Outcome|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
1038446|NCT00722371|O6|Outcome|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
1038447|NCT00722371|O5|Outcome|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
1038448|NCT00722371|O4|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
1038449|NCT00722371|O3|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
1038450|NCT00722371|O2|Outcome|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
1038451|NCT00722371|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
1038452|NCT00722371|O7|Outcome|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
1038453|NCT00722371|O6|Outcome|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
1038454|NCT00722371|O5|Outcome|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
1038455|NCT00722371|O4|Outcome|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
1038456|NCT00722371|O3|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
1038457|NCT00722371|O2|Outcome|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
1038458|NCT00722371|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
1038459|NCT00722371|E7|Reported Event|Sitagliptin 100 mg/ Pioglitazone 45 mg|Sitagliptin 100 mg and pioglitazone 45 mg once daily for 54 weeks.
1038460|NCT00722371|E6|Reported Event|Sitagliptin 100 mg/ Pioglitazone 30 mg|Sitagliptin 100 mg and pioglitazone 30 mg once daily for 54 weeks.
1038461|NCT00722371|E5|Reported Event|Sitagliptin 100 mg/ Pioglitazone 15 mg|Sitagliptin 100 mg and pioglitazone 15 mg once daily for 54 weeks.
1038462|NCT00722371|E4|Reported Event|Pioglitazone 45 mg|Pioglitazone 45 mg and matching placebo to sitagliptin once daily for 54 weeks.
1038463|NCT00722371|E3|Reported Event|Pioglitazone 30 mg|Pioglitazone 30 mg and matching placebo to sitagliptin once daily for 54 weeks.
1038464|NCT00722371|E2|Reported Event|Pioglitazone 15 mg|Pioglitazone 15 mg and matching placebo to sitagliptin once daily for 54 weeks.
1038465|NCT00722371|E1|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg and matching placebo to pioglitazone once daily for 54 weeks.
1038466|NCT00722137|B3|Baseline|Total|Total of all reporting groups
1038467|NCT00722137|B2|Baseline|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~VELCADE: VELCADE intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
1038468|NCT00722137|B1|Baseline|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Vincristine intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
1038484|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
1038939|NCT00721227|E1|Reported Event|Anterior Curve|Reduction Gastroplasty by Gastric Plication on Anterior Curve
1038469|NCT00722137|P2|Participant Flow|R-CHOP|"Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, Vincristine 1.4 mg/m^2 and Prednisone 100 mg/m^2~Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Vincristine intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles"
1038470|NCT00722137|P1|Participant Flow|VcR-CAP|"Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, VELCADE 1.3 mg/m^2, and Prednisone 100 mg/m^2~Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day of a 21 day (3 week) cycle for 6 cycles~VELCADE: VELCADE intravenous on Days 1,4,8, and 11 of a 21 day (3 week) cycle for 6 cycles~Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
1038471|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~VELCADE: VELCADE intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Prednisone per overall survival on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
1038472|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~Prednisone: Prednisone per overall survival on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Vincristine intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
1038473|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~VELCADE: Intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
1038474|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
1038475|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~VELCADE: Intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
1038476|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
1038477|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~VELCADE: Intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Oraly on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
1038478|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
1038479|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~VELCADE: Intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Oraly on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
1038480|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
1038481|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~VELCADE: Intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
1038482|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
1038483|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~VELCADE: Intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
1038485|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~VELCADE: Intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
1038486|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
1038487|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~VELCADE: Intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
1038488|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~Prednisone: Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
1038489|NCT00722137|O2|Outcome|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~VELCADE: intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
1038490|NCT00722137|O1|Outcome|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Vincristine intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
1038491|NCT00722137|E2|Reported Event|VcR-CAP|"Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone~Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~VELCADE: VELCADE intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles~Prednisone: Prednisone per overall survival on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles"
1038492|NCT00722137|E1|Reported Event|R-CHOP|"Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone~Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.~Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles~Doxorubicin: Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles~Prednisone: Prednisone per overall survival on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles~Vincristine: Vincristine intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles"
1038493|NCT00722124|B4|Baseline|Total|Total of all reporting groups
1038494|NCT00722124|B3|Baseline|Placebo|Each subject randomized to this arm will take 2 placebo pills in the AM and again in the PM
1038495|NCT00722124|B2|Baseline|SAMe 1600|Each person randomized to this arm will take 2 400 mg pills of SAMe in the AM and again in the PM
1038496|NCT00722124|B1|Baseline|SAMe 800|Each subject randomized to this arm will take a 400 mg pill of SAMe and one matching placebo pill in the AM and again in the PM
1038497|NCT00722124|P3|Participant Flow|Placebo|Each subject randomized to this arm will take 2 placebo pills in the AM and again in the PM
1038498|NCT00722124|P2|Participant Flow|SAMe 1600|Each person randomized to this arm will take 2 400 mg pills of SAMe in the AM and again in the PM
1038499|NCT00722124|P1|Participant Flow|SAMe 800|Each subject randomized to this arm will take a 400 mg pill of SAMe and one matching placebo pill in the AM and again in the PM
1038500|NCT00722124|O3|Outcome|Placebo|
1038501|NCT00722124|O2|Outcome|SAMe 1600|
1038502|NCT00722124|O1|Outcome|SAMe 800|
1038503|NCT00722124|E3|Reported Event|Placebo|Each subject randomized to this arm will take 2 placebo pills in the AM and again in the PM
1038504|NCT00722124|E2|Reported Event|SAMe 1600|Each person randomized to this arm will take 2 400 mg pills of SAMe in the AM and again in the PM
1038505|NCT00722124|E1|Reported Event|SAMe 800|Each subject randomized to this arm will take a 400 mg pill of SAMe and one matching placebo pill in the AM and again in the PM
1038506|NCT00722072|B1|Baseline|Sorafenib and Fulvestrant|"Fulvestrant:Will be administered to the subject intramuscularly. Administered to all subjects during cycle 1 of treatment as follows:~500 mg IM on Day 1~250 mg IM on Day 15~Sorafenib: 800 mg/day administered as 400 mg bid (twice daily) each morning and evening approximately 12 hours apart. Treatment will begin on Day 1 of the study and continue daily until tumor progression or until an unacceptable toxicity occurs which would require delay, modification or discontinuation of study therapy."
1038507|NCT00722072|P1|Participant Flow|Sorafenib and Fulvestrant|"Fulvestrant:Will be administered to the subject intramuscularly. Administered to all subjects during cycle 1 of treatment as follows:~500 mg IM on Day 1~250 mg IM on Day 15~Sorafenib: 800 mg/day administered as 400 mg bid (twice daily) each morning and evening approximately 12 hours apart. Treatment will begin on Day 1 of the study and continue daily until tumor progression or until an unacceptable toxicity occurs which would require delay, modification or discontinuation of study therapy."
1038508|NCT00722072|O1|Outcome|Sorafenib and Fulvestrant|"Fulvestrant:Will be administered to the subject intramuscularly. Administered to all subjects during cycle 1 of treatment as follows:~500 mg IM on Day 1~250 mg IM on Day 15~Sorafenib: 800 mg/day administered as 400 mg bid (twice daily) each morning and evening approximately 12 hours apart. Treatment will begin on Day 1 of the study and continue daily until tumor progression or until an unacceptable toxicity occurs which would require delay, modification or discontinuation of study therapy."
1039282|NCT00720382|B2|Baseline|Nasonex®|Mometasone furoate 200 mcg
1038509|NCT00722072|E1|Reported Event|Sorafenib and Fulvestrant|"Fulvestrant:Will be administered to the subject intramuscularly. Administered to all subjects during cycle 1 of treatment as follows:~500 mg IM on Day 1~250 mg IM on Day 15~Sorafenib: 800 mg/day administered as 400 mg bid (twice daily) each morning and evening approximately 12 hours apart. Treatment will begin on Day 1 of the study and continue daily until tumor progression or until an unacceptable toxicity occurs which would require delay, modification or discontinuation of study therapy."
1038510|NCT00722020|B3|Baseline|Total|Total of all reporting groups
1038511|NCT00722020|B2|Baseline|Standard Care With Sham Vest|Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.
1038512|NCT00722020|B1|Baseline|HFCWO / VEST|Pediatric patients with primary diagnosis of Asthma received HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment. Patients receive 15 minutes of HFCWO via the Vest.
1038513|NCT00722020|P2|Participant Flow|Standard Care|"Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.~Regular nebulized bronchodilator treatment.: Sham Vest treatment."
1038514|NCT00722020|P1|Participant Flow|HFCWO / VEST Group|"Patients will receive HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment.~High Frequency Chest Wall Oscillation via Vest (Hill-Rom Vest(tm)): Simultaneous to bronchodilator treatment via nebulizer (regular treatment), patients will receive 15 minutes of HFCWO via the Vest."
1038515|NCT00722020|O2|Outcome|Standard Care With Sham Vest|Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.
1038516|NCT00722020|O1|Outcome|HFCWO / VEST|Pediatric patients with primary diagnosis of Asthma received HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment. Patients receive 15 minutes of HFCWO via the Vest.
1038517|NCT00722020|O2|Outcome|Standard Care|"Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.~Regular nebulized bronchodilator treatment.: Sham Vest treatment."
1038518|NCT00722020|O1|Outcome|HFCWO / VEST Group|"Patients will receive HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment.~High Frequency Chest Wall Oscillation via Vest (Hill-Rom Vest(tm)): Simultaneous to bronchodilator treatment via nebulizer (regular treatment), patients will receive 15 minutes of HFCWO via the Vest."
1038519|NCT00722020|E2|Reported Event|Standard Care With Sham Vest|Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.
1038520|NCT00722020|E1|Reported Event|HFCWO / VEST|Pediatric patients with primary diagnosis of Asthma received HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment. Patients receive 15 minutes of HFCWO via the Vest.
1038521|NCT00721968|B3|Baseline|Total|Total of all reporting groups
1038522|NCT00721968|B2|Baseline|2 Control Group: Cataract Surgery Only|Control Group (Group 2): Cataract surgery only
1038523|NCT00721968|B1|Baseline|1 Treatment Group: iStent + Cataract Surgery|Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery
1038524|NCT00721968|P2|Participant Flow|2 Control Group: Cataract Surgery Only|Control Group (Group 2): Cataract surgery only
1038525|NCT00721968|P1|Participant Flow|1 Treatment Group: iStent + Cataract Surgery|Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery
1038526|NCT00721968|O2|Outcome|2 Control Group: Cataract Surgery Only|Control Group (Group 2): Cataract surgery only
1038527|NCT00721968|O1|Outcome|1 Treatment Group: iStent + Cataract Surgery|Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery
1038528|NCT00721968|O2|Outcome|2 Control Group: Cataract Surgery Only|Control Group (Group 2): Cataract surgery only
1038529|NCT00721968|O1|Outcome|1 Treatment Group: iStent + Cataract Surgery|Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery
1038530|NCT00721968|E2|Reported Event|2 Control Group: Cataract Surgery Only|Control Group (Group 2): Cataract surgery only
1038531|NCT00721968|E1|Reported Event|1 Treatment Group: iStent + Cataract Surgery|Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery
1038532|NCT00721734|B6|Baseline|Total|Total of all reporting groups
1038533|NCT00721734|B5|Baseline|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038534|NCT00721734|B4|Baseline|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038535|NCT00721734|B3|Baseline|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038536|NCT00721734|B2|Baseline|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038938|NCT00721227|E2|Reported Event|Greater Curve|Reduction Gastroplasty by Gastric Plication on Greater Curve
1038537|NCT00721734|B1|Baseline|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038538|NCT00721734|P5|Participant Flow|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038539|NCT00721734|P4|Participant Flow|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038540|NCT00721734|P3|Participant Flow|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038541|NCT00721734|P2|Participant Flow|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038542|NCT00721734|P1|Participant Flow|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038543|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038544|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038545|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038546|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038547|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038548|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038549|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038550|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038551|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038885|NCT00721396|E4|Reported Event|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
1038552|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038553|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038554|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038555|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038556|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038557|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038558|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038559|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038560|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038561|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038562|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038563|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038564|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038565|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038566|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038733|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
1038567|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038568|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038569|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038570|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038571|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038572|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038573|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038574|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038575|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038576|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038577|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038578|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038579|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038580|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038581|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038787|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
1038582|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038583|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038584|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038585|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038586|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038587|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038588|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038589|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038590|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038591|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038592|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038593|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038594|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038595|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038596|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038880|NCT00721396|O1|Outcome|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations.
1038597|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038598|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038599|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038600|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038601|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038602|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038603|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038604|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038605|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038606|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038607|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038608|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038609|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038610|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038611|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038881|NCT00721396|O4|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
1053914|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
1038612|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038613|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038614|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038615|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038616|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038617|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038618|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038619|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038620|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038621|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038622|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038623|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038624|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038625|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038626|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038882|NCT00721396|O3|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
1038627|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038628|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038629|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038630|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038631|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038632|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038633|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038634|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038635|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038636|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038637|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038638|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038639|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038640|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038641|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038883|NCT00721396|O2|Outcome|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
1038642|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038643|NCT00721734|O5|Outcome|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038644|NCT00721734|O4|Outcome|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038645|NCT00721734|O3|Outcome|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038646|NCT00721734|O2|Outcome|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038647|NCT00721734|O1|Outcome|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038648|NCT00721734|E5|Reported Event|Carfilzomib – Dialysis|"Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038649|NCT00721734|E4|Reported Event|Carfilzomib – Severe RI|"Participants with severe renal impairment (CrCL < 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038650|NCT00721734|E3|Reported Event|Carfilzomib – Moderate RI|"Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038651|NCT00721734|E2|Reported Event|Carfilzomib – Mild RI|"Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038652|NCT00721734|E1|Reported Event|Carfilzomib – Normal RF|"Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) > 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.~If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles."
1038653|NCT00721617|B1|Baseline|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h.
1038654|NCT00721617|P1|Participant Flow|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
1038655|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
1038656|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
1038657|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
1038658|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
1038659|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
1053915|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
1038660|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
1038661|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
1038662|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
1038663|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
1038664|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
1038665|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
1038666|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
1038667|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
1038668|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
1038669|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
1038670|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
1038671|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
1038672|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
1038673|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
1038674|NCT00721617|O1|Outcome|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
1038675|NCT00721617|O1|Outcome|Healthy Subjects|Subjects received either IV Normal Saline at 20ml/hour, IV Intralipid (20% solution at 20 ml/hour and an oral fat load (96g/24 hours) in a random order.
1038676|NCT00721617|E1|Reported Event|Healthy Subjects|Obese, normotensive, healthy subjects received, in a random order, on four separate occasions, Intralipid 20% at 40 mL/h, dextrose 10% at 40mL/h, combination intralipid 20% and dextrose 10% at 40 mL/h, or normal saline at 40 mL/h
1038677|NCT00721578|B1|Baseline|Entire Study Population|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
1038678|NCT00721578|P2|Participant Flow|Other Antifungal Treatment|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study.
1038679|NCT00721578|P1|Participant Flow|Voriconazole Antifungal Treatment|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study.
1038680|NCT00721578|O1|Outcome|Therapy for Systemic Fungal Infections|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
1038681|NCT00721578|O1|Outcome|Therapy for Systemic Fungal Infection|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
1038682|NCT00721578|O1|Outcome|Therapy for Systemic Fungal Infections|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
1038683|NCT00721578|O1|Outcome|Therapy for Systemic Fungal Infections|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
1038732|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038684|NCT00721578|O1|Outcome|Therapy for Systemic Fungal Infections|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
1038685|NCT00721578|O1|Outcome|Therapy for Systemic Fungal Infections|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
1038686|NCT00721578|O1|Outcome|Therapy for Systemic Fungal Infections|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
1038687|NCT00721578|O1|Outcome|All Antifungal Therapies|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
1038688|NCT00721578|O1|Outcome|All Antifungal Therapies|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
1038689|NCT00721578|E1|Reported Event|Therapy for Systemic Fungal Infections|Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study
1038690|NCT00721539|B1|Baseline|Transoral Robotic Surgery|"Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.~da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.~Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods."
1038691|NCT00721539|P1|Participant Flow|Transoral Robotic Surgery|"Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.~da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.~Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods."
1038692|NCT00721539|O1|Outcome|Transoral Robotic Surgery|"Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.~da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.~Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods."
1038693|NCT00721539|O1|Outcome|Transoral Robotic Surgery|"Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.~da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.~Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods."
1038694|NCT00721539|O1|Outcome|Transoral Robotic Surgery|"Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.~da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.~Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods."
1038695|NCT00721539|O1|Outcome|Transoral Robotic Surgery|"Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.~da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.~Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods."
1038696|NCT00721539|E1|Reported Event|Transoral Robotic Surgery|"Pilot study; single arm - use of da Vinci Surgical Robot Platform to access neoplastic disease of the upper aerodigestive tract.~da Vinci Surgical Robot Platform: daVinci Surgical Robot Platform is a surgical device that enhances transoral access to the upper aerodigestive tract through miniaturization of endoscopes and micromanipulators that can be introduced through the mouth.~Transoral Robotic Surgery: Eligible patients will undergo transoral treatment of neoplastic disease of the upper aerodigestive tract using the daVinci Surgical Robot Platform as opposed to traditional (TOL - transoral laser; TEC - transoral electrocautery) methods."
1038697|NCT00721500|B1|Baseline|All Subjects|All subjects who enrolled and completed study.
1038698|NCT00721500|P4|Participant Flow|Etafilcon A - Narafilcon A - Narafilcon A/Etafilcon A|First, etafilcon A contact lenses worn in both eyes. Second, narafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.
1038884|NCT00721396|O1|Outcome|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
1038699|NCT00721500|P3|Participant Flow|Narafilcon A - Etafilcon A - Narafilcon A/Etafilcon A|First, narafilcon A contact lenses worn in both eyes. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.
1038700|NCT00721500|P2|Participant Flow|Narafilcon A/Etafilcon A - Narafilcon A - Etafilcon A|First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, narafilcon A contact lenses worn in both eyes. Third, etafilcon A contact lenses worn in both eyes.
1038701|NCT00721500|P1|Participant Flow|Narafilcon A/Etafilcon A - Etafilcon A - Narafilcon A|First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A contact lenses worn in both eyes.
1038702|NCT00721500|O4|Outcome|Etafilcon A (Contralateral)|Etafilcon A worn in either eye.
1038703|NCT00721500|O3|Outcome|Etafilcon A (Bilateral)|Etafilcon A contact lens worn in both eyes.
1038704|NCT00721500|O2|Outcome|Narafilcon A (Contralateral)|Narafilcon A worn in either eye.
1038705|NCT00721500|O1|Outcome|Narafilcon A (Bilateral)|Narafilcon A contact lens worn in both eyes.
1038706|NCT00721500|O4|Outcome|Etafilcon A (Contralateral)|Etafilcon A worn in either eye.
1038707|NCT00721500|O3|Outcome|Etafilcon A (Bilateral)|Etafilcon A contact lens worn in both eyes.
1038708|NCT00721500|O2|Outcome|Narafilcon A (Contralateral)|Narafilcon A worn in either eye.
1038709|NCT00721500|O1|Outcome|Narafilcon A|Narafilcon A contact lens worn in both eyes.
1038710|NCT00721500|O4|Outcome|Etafilcon A (Contralateral)|Etafilcon A worn in either eye.
1038711|NCT00721500|O3|Outcome|Etafilcon A (Bilateral)|Etafilcon A contact lens worn in both eyes.
1038712|NCT00721500|O2|Outcome|Narafilcon A (Contralateral)|Narafilcon A worn in either eye.
1038713|NCT00721500|O1|Outcome|Narafilcon A (Bilateral)|narafilcon A contact lens worn in both eyes.
1038714|NCT00721500|E4|Reported Event|Etafilcon A - Narafilcon A - Narafilcon A/Etafilcon A|First, etafilcon A contact lenses worn in both eyes. Second, narafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.
1038715|NCT00721500|E3|Reported Event|Narafilcon A - Etafilcon A - Narafilcon A/Etafilcon A|First, narafilcon A contact lenses worn in both eyes. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.
1038716|NCT00721500|E2|Reported Event|Narafilcon A/Etafilcon A - Narafilcon A - Etafilcon A|First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, narafilcon A contact lenses worn in both eyes. Third, etafilcon A contact lenses worn in both eyes.
1038717|NCT00721500|E1|Reported Event|Narafilcon A/Etafilcon A - Etafilcon A - Narafilcon A|First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A contact lenses worn in both eyes.
1038718|NCT00721409|B4|Baseline|Total|Total of all reporting groups
1038719|NCT00721409|B3|Baseline|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
1038720|NCT00721409|B2|Baseline|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038721|NCT00721409|B1|Baseline|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
1038722|NCT00721409|P3|Participant Flow|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
1038723|NCT00721409|P2|Participant Flow|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038724|NCT00721409|P1|Participant Flow|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
1038725|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
1038726|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038727|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
1038728|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038729|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
1038730|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038731|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
1038734|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038735|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
1038736|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038737|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
1038738|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038739|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
1038740|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038741|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
1038742|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038743|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
1038744|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038745|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
1038746|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038747|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
1038748|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038749|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
1038750|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038751|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
1038752|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038753|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
1038754|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038755|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
1038756|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038757|NCT00721409|O4|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
1038758|NCT00721409|O3|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038759|NCT00721409|O2|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
1053916|NCT00684307|O5|Outcome|VKA INR 2-3|
1038760|NCT00721409|O1|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038761|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
1038762|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038763|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
1038764|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038765|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
1038766|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038767|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
1038768|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038769|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
1038770|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038771|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
1038772|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038773|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
1038774|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038775|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
1038776|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038777|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
1038778|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038779|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
1038780|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038781|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
1038782|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038783|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
1038784|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038785|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
1038786|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038788|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038789|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
1038790|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038791|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
1038792|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038793|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
1038794|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038795|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
1038796|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038797|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
1038798|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038799|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
1038800|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038801|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
1038802|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038803|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
1038804|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038805|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
1038806|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038807|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
1038808|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038809|NCT00721409|O1|Outcome|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
1038810|NCT00721409|O2|Outcome|Letrozole Alone (Cycle 2 Day 28)|Participants received daily 2.5 mg doses of letrozole alone.
1038811|NCT00721409|O1|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|Participants received 125 mg oral doses of palbociclib with daily 2.5 mg doses of letrozole.
1038812|NCT00721409|O2|Outcome|Letrozole Alone (Cycle 2 Day 28)|Participants received daily 2.5 mg doses of letrozole alone.
1038813|NCT00721409|O1|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|Participants received 125 mg oral doses of palbociclib with daily 2.5 mg doses of letrozole.
1038814|NCT00721409|O2|Outcome|Letrozole Alone (Cycle 2 Day 28)|Participants received daily 2.5 mg doses of letrozole alone.
1038815|NCT00721409|O1|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|Participants received 125 mg oral doses of palbociclib with daily 2.5 mg doses of letrozole.
1038935|NCT00721227|O1|Outcome|Anterior Curve|Reduction Gastroplasty by Gastric Plication on Anterior Curve
1038816|NCT00721409|O2|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
1038817|NCT00721409|O1|Outcome|Palbociclib Alone (Cycle 1 Day 14)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment.
1038818|NCT00721409|O2|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
1038819|NCT00721409|O1|Outcome|Palbociclib Alone (Cycle 1 Day 14)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment.
1038820|NCT00721409|O2|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
1038821|NCT00721409|O1|Outcome|Palbociclib Alone (Cycle 1 Day 14)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment.
1038822|NCT00721409|O2|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
1038823|NCT00721409|O1|Outcome|Palbociclib Alone (Cycle 1 Day 14)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment.
1038824|NCT00721409|O2|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
1038825|NCT00721409|O1|Outcome|Palbociclib Alone (Cycle 1 Day 14)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment.
1038826|NCT00721409|O2|Outcome|Palbociclib + Letrozole (Cycle 2 Day 14)|In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
1038827|NCT00721409|O1|Outcome|Palbociclib Alone (Cycle 1 Day 14)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment.
1038828|NCT00721409|O1|Outcome|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
1038829|NCT00721409|O1|Outcome|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
1038830|NCT00721409|O6|Outcome|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
1038831|NCT00721409|O5|Outcome|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038832|NCT00721409|O4|Outcome|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
1038833|NCT00721409|O3|Outcome|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038834|NCT00721409|O2|Outcome|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
1038835|NCT00721409|O1|Outcome|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038836|NCT00721409|O1|Outcome|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
1038837|NCT00721409|O1|Outcome|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
1038838|NCT00721409|O1|Outcome|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
1038839|NCT00721409|E7|Reported Event|Ph2P2 (Letrozole)|Participants were randomized to receive letrozole. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
1038840|NCT00721409|E6|Reported Event|Ph2P2 (Palbociclib + Letrozole)|Participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038841|NCT00721409|E5|Reported Event|Ph2P1 (Letrozole)|Participants were randomized to receive letrozole alone. Letrozole 2.5 mg/d was administered orally in a continuous regimen. This was considered as control arm.
1038842|NCT00721409|E4|Reported Event|Ph2P1 (Palbociclib + Letrozole)|All participants were randomized to receive letrozole plus palbociclib. Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1053917|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
1038843|NCT00721409|E3|Reported Event|Phase 2 (Letrozole)|All participants who were randomized to receive letrozole alone in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. This was considered as control arm. Letrozole 2.5 mg/d was administered orally in a continuous regimen.
1038844|NCT00721409|E2|Reported Event|Phase 2 (Palbociclib + Letrozole)|All participants who were randomized to letrozole plus palbociclib in both Phase 2 part 1 (Ph2P1) and Phase 2 part 2 (Ph2P2) are combined and presented. In Ph2P1 and Ph2P2, the participants received palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment and letrozole 2.5 mg/d orally in a continuous regimen.
1038845|NCT00721409|E1|Reported Event|Phase 1 (Palbociclib + Letrozole)|In Cycle 1 (3 weeks), participants received single agent palbociclib 125 mg/d orally for 2 weeks followed by 1 week off treatment. In Cycles 2 and beyond (4 weeks each), participants received letrozole 2.5 mg/d in a continuous regimen plus Palbociclib 125 mg/d orally for 3 weeks followed by 1 week off treatment.
1038846|NCT00721396|B5|Baseline|Total|Total of all reporting groups
1038847|NCT00721396|B4|Baseline|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
1038848|NCT00721396|B3|Baseline|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
1038849|NCT00721396|B2|Baseline|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
1038850|NCT00721396|B1|Baseline|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
1038851|NCT00721396|P4|Participant Flow|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
1038852|NCT00721396|P3|Participant Flow|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
1038853|NCT00721396|P2|Participant Flow|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
1038854|NCT00721396|P1|Participant Flow|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
1038855|NCT00721396|O2|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
1038856|NCT00721396|O1|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
1038857|NCT00721396|O4|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
1038858|NCT00721396|O3|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
1038859|NCT00721396|O2|Outcome|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
1038860|NCT00721396|O1|Outcome|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
1038861|NCT00721396|O4|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
1038862|NCT00721396|O3|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
1038863|NCT00721396|O2|Outcome|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
1038864|NCT00721396|O1|Outcome|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
1038865|NCT00721396|O4|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
1038866|NCT00721396|O3|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
1038867|NCT00721396|O2|Outcome|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
1038868|NCT00721396|O1|Outcome|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
1038869|NCT00721396|O4|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
1038870|NCT00721396|O3|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
1038871|NCT00721396|O2|Outcome|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
1038872|NCT00721396|O1|Outcome|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
1038873|NCT00721396|O2|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
1038874|NCT00721396|O1|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
1038875|NCT00721396|O2|Outcome|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
1038876|NCT00721396|O1|Outcome|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
1038877|NCT00721396|O4|Outcome|R234|Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
1038878|NCT00721396|O3|Outcome|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations.
1038879|NCT00721396|O2|Outcome|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age.
1038886|NCT00721396|E3|Reported Event|B+R234|Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
1038887|NCT00721396|E2|Reported Event|B246_R357|Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
1038888|NCT00721396|E1|Reported Event|B+R246|Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
1038889|NCT00721357|B3|Baseline|Total|Total of all reporting groups
1038890|NCT00721357|B2|Baseline|Control|"those without condition~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
1038891|NCT00721357|B1|Baseline|Stroke|"those with condition~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
1038892|NCT00721357|P2|Participant Flow|Control|"those without condition~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
1038893|NCT00721357|P1|Participant Flow|Stroke|"those with condition~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
1038894|NCT00721357|O2|Outcome|Control|"those without condition~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
1038895|NCT00721357|O1|Outcome|Stroke|"those with condition~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
1038896|NCT00721357|E2|Reported Event|Group 2|"those without condition~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
1038897|NCT00721357|E1|Reported Event|Group 1|"those with condition~Treadmill walking: Subjects will perform treadmill walking at a self-selected velocity~Magnetic resonance spectroscopy: Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)"
1038898|NCT00721279|B3|Baseline|Total|Total of all reporting groups
1038899|NCT00721279|B2|Baseline|Pre-treated Patients|Patients that had been treated for RLS at baseline
1038900|NCT00721279|B1|Baseline|De-novo Patients|Patients that had not been treated for RLS at baseline
1038901|NCT00721279|P2|Participant Flow|Pre-treated Patients|Patients that had been treated for RLS at baseline
1038902|NCT00721279|P1|Participant Flow|De-novo Patients|Patients that had not been treated for RLS at baseline
1038903|NCT00721279|O1|Outcome|Overall|All Patients
1038904|NCT00721279|O1|Outcome|Overall|All Patients
1038905|NCT00721279|O2|Outcome|Pre-treated Patients|Patients that had been treated for RLS at baseline
1038906|NCT00721279|O1|Outcome|De-novo Patients|Patients that had not been treated for RLS at baseline
1038907|NCT00721279|O2|Outcome|Pre-treated Patients|Patients that had been treated for RLS at baseline
1038908|NCT00721279|O1|Outcome|De-novo Patients|Patients that had not been treated for RLS at baseline
1038909|NCT00721279|O2|Outcome|Pre-treated Patients|Patients that had been treated for RLS at baseline
1038910|NCT00721279|O1|Outcome|De-novo Patients|Patients that had not been treated for RLS at baseline
1038911|NCT00721279|E2|Reported Event|Pre-treated Patients|Patients that had been treated for RLS at baseline
1038912|NCT00721279|E1|Reported Event|De-novo Patients|Patients that had not been treated for RLS at baseline
1038913|NCT00721253|B3|Baseline|Total|Total of all reporting groups
1038914|NCT00721253|B2|Baseline|Acri LISA IOL|Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
1038915|NCT00721253|B1|Baseline|ReSTOR Aspheric +4|Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
1038916|NCT00721253|P3|Participant Flow|Tecnis MF|Abbott Medical Optics Tecnis Multifocal Intraocular Lens (IOL) Model ZM900
1038917|NCT00721253|P2|Participant Flow|Acri LISA IOL|Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
1038918|NCT00721253|P1|Participant Flow|ReSTOR Aspheric +4|Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
1038919|NCT00721253|O2|Outcome|Acri LISA IOL|Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
1038920|NCT00721253|O1|Outcome|ReSTOR Aspheric +4|Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
1038921|NCT00721253|O2|Outcome|Acri LISA IOL|Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
1038922|NCT00721253|O1|Outcome|ReSTOR Aspheric +4|Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
1038923|NCT00721253|O2|Outcome|Acri LISA IOL|Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
1038924|NCT00721253|O1|Outcome|ReSTOR Aspheric +4|Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
1038925|NCT00721253|E2|Reported Event|Acri LISA IOL|Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
1038926|NCT00721253|E1|Reported Event|ReSTOR Aspheric +4|Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3
1038927|NCT00721227|B3|Baseline|Total|Total of all reporting groups
1038928|NCT00721227|B2|Baseline|Greater Curve|Reduction Gastroplasty by Gastric Plication on Greater Curve
1038929|NCT00721227|B1|Baseline|Anterior Curve|Reduction Gastroplasty by Gastric Plication on Anterior Curve
1038930|NCT00721227|P2|Participant Flow|Greater Curve|Reduction Gastroplasty by Gastric Plication on Greater Curve
1038931|NCT00721227|P1|Participant Flow|Anterior Curve|Reduction Gastroplasty by Gastric Plication on Anterior Curve
1038932|NCT00721227|O2|Outcome|Greater Curve|Reduction Gastroplasty by Gastric Plication on Greater Curve
1038933|NCT00721227|O1|Outcome|Anterior Curve|Reduction Gastroplasty by Gastric Plication on Anterior Curve
1038934|NCT00721227|O2|Outcome|Greater Curve|Reduction Gastroplasty by Gastric Plication on Greater Curve
1038940|NCT00721214|B1|Baseline|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
1038941|NCT00721214|P1|Participant Flow|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
1038942|NCT00721214|O1|Outcome|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
1038943|NCT00721214|O1|Outcome|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
1038944|NCT00721214|O1|Outcome|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
1038945|NCT00721214|O1|Outcome|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
1038946|NCT00721214|O1|Outcome|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
1038947|NCT00721214|O1|Outcome|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
1038948|NCT00721214|O1|Outcome|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
1038949|NCT00721214|O1|Outcome|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
1038950|NCT00721214|E1|Reported Event|Arm A: 5-azacytidine|"5-azacytidine as pre-transplant cytoreduction prior to allogeneic stem cell transplantation for High Risk Myelodysplatic Syndromes.~5-azacytidine: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days."
1038951|NCT00721188|B1|Baseline|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
1038952|NCT00721188|P1|Participant Flow|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
1038953|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
1038954|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
1038955|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
1038956|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
1038957|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
1038958|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
1038959|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
1038960|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
1038961|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
1038962|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
1038963|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
1038964|NCT00721188|O1|Outcome|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
1038965|NCT00721188|E1|Reported Event|Venofer (Iron Sucrose Injection)|All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
1038966|NCT00721175|B3|Baseline|Total|Total of all reporting groups
1038967|NCT00721175|B2|Baseline|Plastic Stent|plastic stent group
1038968|NCT00721175|B1|Baseline|SEMS|self-expandable metal stent group
1038969|NCT00721175|P2|Participant Flow|Plastic Stent|plastic stent group
1038974|NCT00721175|O1|Outcome|SEMS|SEMS (Self-expandable metal stent group)
1038978|NCT00721175|O1|Outcome|SEMS|SEMS (Self-expandable metal stent group)
1038979|NCT00721175|E2|Reported Event|Plastic Stent|plastic stent group
1038980|NCT00721175|E1|Reported Event|SEMS|self-expandable metal stent group
1038981|NCT00721162|B1|Baseline|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
1038982|NCT00721162|P1|Participant Flow|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
1038983|NCT00721162|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
1038984|NCT00721162|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
1038985|NCT00721162|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
1038986|NCT00721162|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
1038987|NCT00721162|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
1038988|NCT00721162|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
1038989|NCT00721162|E1|Reported Event|Ramucirumab|Ramucirumab at 8 milligrams/kilogram (mg/kg) administered intravenously over 1 hour every other week (every 14 days) of a 28-day cycle.
1038990|NCT00721149|B1|Baseline|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
1038991|NCT00721149|P1|Participant Flow|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
1038992|NCT00721149|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
1038993|NCT00721149|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
1038994|NCT00721149|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
1038995|NCT00721149|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
1038996|NCT00721149|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
1038997|NCT00721149|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
1038998|NCT00721149|E1|Reported Event|NAVISTAR® THERMOCOOL® Catheter|The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
1038999|NCT00721123|B1|Baseline|Tocilizumab 8 mg/kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
1039000|NCT00721123|P1|Participant Flow|Tocilizumab 8 mg/kg|Patients received tocilizumab (TCZ) 8 mg/kg intravenously every 4 weeks.
1039001|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
1039002|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
1039003|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
1039004|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
1039005|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
1039006|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
1039007|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
1039008|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
1039009|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
1039010|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
1039011|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
1039012|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
1039013|NCT00721123|O1|Outcome|Tocilizumab 8 mg/kg|Patients received tocilizumab (TCZ) 8 mg/kg intravenously every 4 weeks.
1053918|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
1039014|NCT00721123|O5|Outcome|Months Greater Than 48|Participants with scores during Months greater than 48, which equates to Weeks 193-264 (Total PY=731.93).
1039015|NCT00721123|O4|Outcome|Months 37 − 48|Participants with scores during Months 37 − 48, which equates to Weeks 145-192 (Total PY=388.25).
1039016|NCT00721123|O3|Outcome|Months 25 - 36|Participants with scores during Months 25 - 36, which equates to Weeks 97-144 (Total PY=410.93).
1039017|NCT00721123|O2|Outcome|Months 13 − 24|Participants with scores during Months 13 − 24, which equates to Weeks 49-96 (Total PY=444.49).
1039018|NCT00721123|O1|Outcome|Months 0 - 12|Participants with scores during Months 0-12, which equates to baseline through Week 48 (Total PY=486.34).
1039019|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
1039020|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
1039021|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
1039022|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
1039023|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
1039024|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
1039025|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
1039026|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
1039027|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
1039028|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
1039029|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
1039030|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
1039031|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
1039032|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
1039033|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
1039034|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
1039035|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
1039036|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
1039037|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
1039038|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
1039039|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
1039040|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
1039041|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
1039042|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
1039043|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
1039044|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
1039045|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
1039046|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
1039047|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
1039048|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
1039049|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
1039050|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
1039051|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
1039052|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
1039053|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
1039054|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
1039055|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
1039056|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
1039057|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
1039058|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
1039059|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
1039060|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
1039061|NCT00721123|O6|Outcome|Week 264|Participants with scores at 264 weeks post-baseline.
1039062|NCT00721123|O5|Outcome|Week 204|Participants with scores at 204 weeks post-baseline.
1039063|NCT00721123|O4|Outcome|Week 156|Participants with scores at 156 weeks post-baseline.
1039064|NCT00721123|O3|Outcome|Week 108|Participants with scores at 108 weeks post-baseline.
1039065|NCT00721123|O2|Outcome|Week 48|Participants with scores at 48 weeks post-baseline.
1039066|NCT00721123|O1|Outcome|Week 24|Participants with scores at 24 weeks post-baseline.
1039067|NCT00721123|O5|Outcome|Months Greater Than 48|Participants with scores during Months greater than 48, which equates to Weeks 193-264.
1039068|NCT00721123|O4|Outcome|Months 37 − 48|Participants with scores during Months 37 − 48, which equates to Weeks 145-192.
1039069|NCT00721123|O3|Outcome|Months 25 - 36|Participants with scores during Months 25 - 36, which equates to Weeks 97-144.
1039070|NCT00721123|O2|Outcome|Months 13 − 24|Participants with scores during Months 13 − 24, which equates to Weeks 49-96.
1039071|NCT00721123|O1|Outcome|Months 0 - 12|Participants with scores during Months 0-12, which equates to baseline through Week 48.
1039072|NCT00721123|E1|Reported Event|Tocilizumab 8 mg/kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
1039073|NCT00720941|B3|Baseline|Total|Total of all reporting groups
1039074|NCT00720941|B2|Baseline|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039075|NCT00720941|B1|Baseline|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039076|NCT00720941|P2|Participant Flow|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039077|NCT00720941|P1|Participant Flow|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039078|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039079|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039080|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039081|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039082|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039083|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039084|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039085|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039086|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039087|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039088|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039089|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039090|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039091|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039092|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039093|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039094|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039095|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039096|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039097|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039098|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039099|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039100|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039101|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039102|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039103|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039104|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039105|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039106|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039107|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039108|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039109|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039110|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039111|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039112|NCT00720941|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039113|NCT00720941|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039114|NCT00720941|E2|Reported Event|Sunitinib 50 mg|Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039115|NCT00720941|E1|Reported Event|Pazopanib 800 mg|Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
1039116|NCT00720798|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
1039117|NCT00720798|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
1039118|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
1039119|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
1039120|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
1039121|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
1039122|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
1039123|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
1039124|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
1039125|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
1039126|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
1039127|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
1039128|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
1039129|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
1039130|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
1039131|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
1039132|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
1039133|NCT00720798|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
1039134|NCT00720798|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
1039135|NCT00720759|B5|Baseline|Total|Total of all reporting groups
1039136|NCT00720759|B4|Baseline|Arm 4|"Placebo + condensed treatment~Placebo + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session"
1039137|NCT00720759|B3|Baseline|Arm 3|"Placebo + distributed treatment~Placebo + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session"
1039138|NCT00720759|B2|Baseline|Arm 2|"D-cycloserine + condensed treatment~D-cycloserine + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
1039283|NCT00720382|B1|Baseline|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg
1039284|NCT00720382|P2|Participant Flow|Nasonex®|Mometasone furoate 200 mcg
1039139|NCT00720759|B1|Baseline|Arm 1|"D-cycloserine + distributed treatment~D-cycloserine + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
1084266|NCT00605085|E2|Reported Event|Placebo|Placebo
1039140|NCT00720759|P4|Participant Flow|Arm 4|"Placebo + condensed treatment~Placebo + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session"
1039141|NCT00720759|P3|Participant Flow|Arm 3|"Placebo + distributed treatment~Placebo + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session"
1039142|NCT00720759|P2|Participant Flow|Arm 2|"D-cycloserine + condensed treatment~D-cycloserine + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
1039143|NCT00720759|P1|Participant Flow|Arm 1|"D-cycloserine + distributed treatment~D-cycloserine + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
1039144|NCT00720759|O4|Outcome|Arm 4|"Placebo + condensed treatment~Placebo + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session"
1039145|NCT00720759|O3|Outcome|Arm 3|"Placebo + distributed treatment~Placebo + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session"
1039146|NCT00720759|O2|Outcome|Arm 2|"D-cycloserine + condensed treatment~D-cycloserine + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
1039147|NCT00720759|O1|Outcome|Arm 1|"D-cycloserine + distributed treatment~D-cycloserine + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
1039148|NCT00720759|E4|Reported Event|Arm 4|"Placebo + condensed treatment~Placebo + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session"
1039149|NCT00720759|E3|Reported Event|Arm 3|"Placebo + distributed treatment~Placebo + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session"
1039150|NCT00720759|E2|Reported Event|Arm 2|"D-cycloserine + condensed treatment~D-cycloserine + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
1039151|NCT00720759|E1|Reported Event|Arm 1|"D-cycloserine + distributed treatment~D-cycloserine + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session"
1039152|NCT00720629|B1|Baseline|First Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
1039153|NCT00720629|P1|Participant Flow|First Study Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
1039154|NCT00720629|O1|Outcome|First Study Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
1039155|NCT00720629|O1|Outcome|First Study Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
1039156|NCT00720629|O2|Outcome|5 Year Analysis Group|First Study Stage: Study Treatment. Visilizumab, Tacrolimus and Methotrexate.
1039157|NCT00720629|O1|Outcome|2 Year Analysis Group|First Study Stage: Study Treatment. Visilizumab, Tacrolimus and Methotrexate.
1039158|NCT00720629|O1|Outcome|First Study Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
1039159|NCT00720629|O1|Outcome|First Study Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
1039160|NCT00720629|O1|Outcome|First Study Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
1039161|NCT00720629|E1|Reported Event|First Stage: Study Treatment|Visilizumab, Tacrolimus and Methotrexate. All participants.
1039162|NCT00720499|B1|Baseline|Overall Study|"A randomised, double-blind, 2-way cross-over study. The two treatment periods were separated by a wash-out period of 14 days during which they received open-label Tiotropium 5 mcg. The 2 treatments, administered once daily in the morning via the respimat inhaler, were :~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg"
1039163|NCT00720499|P2|Participant Flow|Tio+Olo5/5µg / Tio+Olo5/2µg|"Patients received fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol (BI1744) 5 µg followed by fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol (BI1744) 2 µg.~Both treatments were administered once daily in the morning via the respimat inhaler."
1039164|NCT00720499|P1|Participant Flow|Tio+Olo 5/2µg / Tio+Olo5/5µg|"Patients received fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol (BI1744) 2 µg followed by fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol (BI1744) 5 µg.~Both treatments were administered once daily in the morning via the respimat inhaler."
1039165|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039166|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039167|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039168|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039285|NCT00720382|P1|Participant Flow|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg
1039286|NCT00720382|O2|Outcome|Nasonex®|Mometasone furoate 200 mcg
1039169|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039170|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039171|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039172|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039173|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039174|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039175|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039176|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039177|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039178|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039179|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039180|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039181|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039182|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039183|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039184|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039185|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039186|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039187|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039188|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039189|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039190|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039191|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039192|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039193|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039287|NCT00720382|O1|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg
1039288|NCT00720382|O2|Outcome|Nasonex®|Mometasone furoate 200 mcg
1039194|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039195|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039196|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039197|NCT00720499|O2|Outcome|Olo 5 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039198|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039199|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039200|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039201|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039202|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039203|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039204|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039205|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039206|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039207|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039208|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039209|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039210|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039211|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039212|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039213|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039214|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039215|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039216|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039217|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039218|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039219|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039220|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039221|NCT00720499|O2|Outcome|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039222|NCT00720499|O1|Outcome|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039223|NCT00720499|E2|Reported Event|Olo 5 µg + Tio5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039224|NCT00720499|E1|Reported Event|Olo 2 µg + Tio 5 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1039225|NCT00720473|B3|Baseline|Total|Total of all reporting groups
1039226|NCT00720473|B2|Baseline|Control Subjects|Age matched controls without BPD
1039227|NCT00720473|B1|Baseline|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
1039228|NCT00720473|P2|Participant Flow|B: Healthy Control|No Intervention
1039229|NCT00720473|P1|Participant Flow|A: BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
1039230|NCT00720473|O2|Outcome|Control Subjects|Age matched controls without BPD
1039231|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
1039232|NCT00720473|O2|Outcome|Control Subjects|Age matched controls without BPD
1039233|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
1039234|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
1039235|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
1039236|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
1039237|NCT00720473|O2|Outcome|Control Subjects|Age matched controls without BPD
1039238|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
1039239|NCT00720473|O2|Outcome|Control Subjects|Age matched controls without BPD
1039240|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
1039241|NCT00720473|O2|Outcome|Control Subjects|Age matched controls without BPD
1039242|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
1039243|NCT00720473|O1|Outcome|A: Other|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
1039244|NCT00720473|O2|Outcome|Control Subjects|Age matched controls without BPD
1039245|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
1039246|NCT00720473|O2|Outcome|Control Subjects|Age matched controls without BPD
1039247|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
1039248|NCT00720473|O2|Outcome|Control Subjects|Age matched controls without BPD
1039249|NCT00720473|O1|Outcome|BPD Subjects|"Open Label Study~Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day."
1039250|NCT00720473|E2|Reported Event|BPD Subjects|
1039251|NCT00720473|E1|Reported Event|Control Subjects|Age matched controls without BPD
1039252|NCT00720434|B5|Baseline|Total|Total of all reporting groups
1039253|NCT00720434|B4|Baseline|Placebo + pegIFN Alfa-2a/RBV|Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
1039254|NCT00720434|B3|Baseline|PF-00868554 500 mg + pegIFN Alfa-2a/RBV|PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
1039255|NCT00720434|B2|Baseline|PF-00868554 300 mg + pegIFN Alfa-2a/RBV|PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
1039256|NCT00720434|B1|Baseline|PF-00868554 200 mg + pegIFN Alfa-2a/RBV|PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
1039289|NCT00720382|O1|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg
1039291|NCT00720382|E1|Reported Event|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg
1039292|NCT00720369|B3|Baseline|Total|Total of all reporting groups
1039353|NCT00720278|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
1039257|NCT00720434|P4|Participant Flow|Placebo + pegIFN Alfa-2a/RBV|Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
1039258|NCT00720434|P3|Participant Flow|PF-00868554 500 mg + pegIFN Alfa-2a/RBV|PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
1039259|NCT00720434|P2|Participant Flow|PF-00868554 300 mg + pegIFN Alfa-2a/RBV|PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
1039260|NCT00720434|P1|Participant Flow|PF-00868554 200 mg + pegIFN Alfa-2a/RBV|PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
1039261|NCT00720434|O4|Outcome|Placebo + pegIFN Alfa-2a/RBV|Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
1039262|NCT00720434|O3|Outcome|PF-00868554 500 mg + pegIFN Alfa-2a/RBV|PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
1039263|NCT00720434|O2|Outcome|PF-00868554 300 mg + pegIFN Alfa-2a/RBV|PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
1039264|NCT00720434|O1|Outcome|PF-00868554 200 mg + pegIFN Alfa-2a/RBV|PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
1039265|NCT00720434|O4|Outcome|Placebo + pegIFN Alfa-2a/RBV|Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
1039266|NCT00720434|O3|Outcome|PF-00868554 500 mg + pegIFN Alfa-2a/RBV|PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
1039267|NCT00720434|O2|Outcome|PF-00868554 300 mg + pegIFN Alfa-2a/RBV|PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
1039268|NCT00720434|O1|Outcome|PF-00868554 200 mg + pegIFN Alfa-2a/RBV|PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
1039290|NCT00720382|E2|Reported Event|Nasonex®|Mometasone furoate 200 mcg
1039269|NCT00720434|O4|Outcome|Placebo + pegIFN Alfa-2a/RBV|Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
1039270|NCT00720434|O3|Outcome|PF-00868554 500 mg + pegIFN Alfa-2a/RBV|PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
1039271|NCT00720434|O2|Outcome|PF-00868554 300 mg + pegIFN Alfa-2a/RBV|PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
1039272|NCT00720434|O1|Outcome|PF-00868554 200 mg + pegIFN Alfa-2a/RBV|PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
1039273|NCT00720434|O4|Outcome|Placebo + pegIFN Alfa-2a/RBV|Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
1039274|NCT00720434|O3|Outcome|PF-00868554 500 mg + pegIFN Alfa-2a/RBV|PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
1039275|NCT00720434|O2|Outcome|PF-00868554 300 mg + pegIFN Alfa-2a/RBV|PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
1039276|NCT00720434|O1|Outcome|PF-00868554 200 mg + pegIFN Alfa-2a/RBV|PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
1039277|NCT00720434|E4|Reported Event|Placebo + pegIFN Alfa-2a/RBV|Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
1039278|NCT00720434|E3|Reported Event|PF-00868554 500 mg + pegIFN Alfa-2a/RBV|PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
1039279|NCT00720434|E2|Reported Event|PF-00868554 300 mg + pegIFN Alfa-2a/RBV|PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
1039280|NCT00720434|E1|Reported Event|PF-00868554 200 mg + pegIFN Alfa-2a/RBV|PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
1039281|NCT00720382|B3|Baseline|Total|Total of all reporting groups
1039293|NCT00720369|B2|Baseline|Healthy Controls|Healthy age matched control subjects do not receive treatment. Controls undergo testing and MRIs to serve as comparison group. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
1039294|NCT00720369|B1|Baseline|CoQ10|Subjects were given open-label, adjunct treatment with CoQ10 with oral dosing between 400-1200mg per day. Dosing was started at 400mg and titrated up to 1200mg as tolerated. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
1039295|NCT00720369|P2|Participant Flow|Healthy Controls|Healthy age matched control subjects do not receive treatment. Controls undergo testing and MRIs to serve as comparison group. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
1039296|NCT00720369|P1|Participant Flow|CoQ10|Subjects were given open-label, adjunct treatment with CoQ10 with oral dosing between 400-1200mg per day. Dosing was started at 400mg and titrated up to 1200mg as tolerated. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
1039297|NCT00720369|O2|Outcome|Healthy Controls|Clinical improvement following treatment with CoQ10 supplement was only tested in the Bipolar subject cohort, not in healthy controls, therefore outcome data only apply to the bipolar group.
1039298|NCT00720369|O1|Outcome|CoQ10|Open Label Study
1039299|NCT00720369|O2|Outcome|Healthy Controls|Healthy age matched control subjects do not receive treatment. Controls undergo testing and MRIs to serve as comparison group.
1039300|NCT00720369|O1|Outcome|CoQ10|Subjects were given open-label, adjunct treatment with CoQ10 with oral dosing between 400-1200mg per day. Dosing was started at 400mg and titrated up to 1200mg as tolerated.
1039301|NCT00720369|E2|Reported Event|Healthy Controls|Healthy age matched control subjects do not receive treatment. Controls undergo testing and MRIs to serve as comparison group. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
1039302|NCT00720369|E1|Reported Event|CoQ10|Subjects were given open-label, adjunct treatment with CoQ10 with oral dosing between 400-1200mg per day. Dosing was started at 400mg and titrated up to 1200mg as tolerated. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
1039303|NCT00720343|B1|Baseline|Choline or Placebo|"Oral choline or Placebo~Choline: Oral Choline or Placebo 20 grams before surgery"
1039304|NCT00720343|P1|Participant Flow|Choline or Placebo|"Oral choline or Placebo~Choline: Oral Choline or Placebo 20 grams before surgery"
1039305|NCT00720343|O2|Outcome|Placebo|"Gelatin Capsule~Placebo: Gelatin Capsule"
1039306|NCT00720343|O1|Outcome|Choline|"Oral choline~Choline: Oral Choline 20 grams before surgery"
1039307|NCT00720343|E2|Reported Event|Placebo|"Gelatin Capsule~Placebo: Gelatin Capsule"
1039308|NCT00720343|E1|Reported Event|Choline|"Oral choline~Choline: Oral Choline 20 grams before surgery"
1039309|NCT00720330|B4|Baseline|Total|Total of all reporting groups
1039310|NCT00720330|B3|Baseline|Placebo|"General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery~placebo: placebo"
1039311|NCT00720330|B2|Baseline|Lidocaine/Ketamine|"Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery.~Lidocaine/Ketamine: Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg)."
1039312|NCT00720330|B1|Baseline|Ropivacaine|"Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation~ropivacaine: 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation"
1039313|NCT00720330|P3|Participant Flow|Placebo|"General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery~placebo: placebo"
1039314|NCT00720330|P2|Participant Flow|Lidocaine/Ketamine|"Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery.~Lidocaine/Ketamine: Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg)."
1039315|NCT00720330|P1|Participant Flow|Ropivacaine|"Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation~ropivacaine: 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation"
1039316|NCT00720330|O3|Outcome|Placebo|"General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery~placebo: placebo"
1039317|NCT00720330|O2|Outcome|Lidocaine/Ketamine|"Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery.~Lidocaine/Ketamine: Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg)."
1039318|NCT00720330|O1|Outcome|Ropivacaine|"Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation~ropivacaine: 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation"
1039319|NCT00720330|O3|Outcome|Placebo|"General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery~placebo: placebo"
1039350|NCT00720278|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
1039351|NCT00720278|O2|Outcome|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
1039352|NCT00720278|O1|Outcome|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
1084267|NCT00605085|E1|Reported Event|IC51|IC51
1039320|NCT00720330|O2|Outcome|Lidocaine/Ketamine|"Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery.~Lidocaine/Ketamine: Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg)."
1039321|NCT00720330|O1|Outcome|Ropivacaine|"Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation~ropivacaine: 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation"
1039322|NCT00720330|O3|Outcome|Placebo|"General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery~placebo: placebo"
1039323|NCT00720330|O2|Outcome|Lidocaine/Ketamine|"Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery.~Lidocaine/Ketamine: Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg)."
1039324|NCT00720330|O1|Outcome|Ropivacaine|"Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation~ropivacaine: 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation"
1039325|NCT00720330|O3|Outcome|Placebo|"General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery~placebo: placebo"
1039326|NCT00720330|O2|Outcome|Lidocaine/Ketamine|"Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery.~Lidocaine/Ketamine: Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg)."
1039327|NCT00720330|O1|Outcome|Ropivacaine|"Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation~ropivacaine: 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation"
1039328|NCT00720330|O3|Outcome|Placebo|"General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery~placebo: placebo"
1039329|NCT00720330|O2|Outcome|Lidocaine/Ketamine|"Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery.~Lidocaine/Ketamine: Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg)."
1039330|NCT00720330|O1|Outcome|Ropivacaine|"Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation~ropivacaine: 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation"
1039331|NCT00720330|E3|Reported Event|Placebo|"General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery~placebo: placebo"
1039332|NCT00720330|E2|Reported Event|Lidocaine/Ketamine|"Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery.~Lidocaine/Ketamine: Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg)."
1039333|NCT00720330|E1|Reported Event|Ropivacaine|"Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation~ropivacaine: 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation"
1039334|NCT00720278|B4|Baseline|Total|Total of all reporting groups
1039335|NCT00720278|B3|Baseline|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
1039336|NCT00720278|B2|Baseline|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
1039337|NCT00720278|B1|Baseline|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
1039338|NCT00720278|P3|Participant Flow|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
1039339|NCT00720278|P2|Participant Flow|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
1039340|NCT00720278|P1|Participant Flow|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
1039341|NCT00720278|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
1039342|NCT00720278|O2|Outcome|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
1039343|NCT00720278|O1|Outcome|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
1039344|NCT00720278|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
1039345|NCT00720278|O2|Outcome|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
1039346|NCT00720278|O1|Outcome|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
1039347|NCT00720278|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
1039348|NCT00720278|O2|Outcome|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
1039349|NCT00720278|O1|Outcome|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
1039354|NCT00720278|O2|Outcome|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
1039355|NCT00720278|O1|Outcome|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
1039356|NCT00720278|E3|Reported Event|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
1039357|NCT00720278|E2|Reported Event|Astepro 0.1%|0.1% azelastine hydrochloride Nasal Spray taken 2 sprays per nostril twice a day for 14 days
1039358|NCT00720278|E1|Reported Event|Placebo|Placebo Nasal Spray taken 2 sprays per nostril twice a day for 14 days
1039359|NCT00720226|B3|Baseline|Total|Total of all reporting groups
1039360|NCT00720226|B2|Baseline|Placebo|Placebo 1 tablet daily
1039361|NCT00720226|B1|Baseline|Losartan|Losartan 100 mg daily
1039362|NCT00720226|P2|Participant Flow|Placebo|"Placebo 1 pill daily~Placebo: Placebo pill daily"
1039363|NCT00720226|P1|Participant Flow|Losartan|"Losartan 100 mg daily~Losartan: Losartan 100 mg daily"
1039364|NCT00720226|O2|Outcome|Placebo|Placebo: Placebo pill daily (Participants with 5-35% emphysema)
1039365|NCT00720226|O1|Outcome|Losartan|Losartan: Losartan 100 mg daily (participants with 5-35% emphysema)
1039366|NCT00720226|O2|Outcome|Placebo|Placebo: Placebo pill daily (Participants with 5-35% emphysema)
1039367|NCT00720226|O1|Outcome|Losartan|Losartan: Losartan 100 mg daily (participants with 5-35% emphysema)
1039368|NCT00720226|E2|Reported Event|Placebo|"Placebo 1 pill daily~Placebo: Placebo pill daily"
1039369|NCT00720226|E1|Reported Event|Losartan 100 mg Daily|"Losartan 100 mg daily~Losartan: Losartan 100 mg daily"
1039370|NCT00720122|B1|Baseline|Anorexia Nervosa Females|Females aged 12 - 26 years Subjects received 30 mcg/kg/dose of recombinant human insulin like growth factor-1 (rhIGF-1) twice daily subcutaneously
1039371|NCT00720122|P1|Participant Flow|Anorexia Nervosa Females|Females aged 12 - 26 years Subjects received 30 mcg/kg/dose of recombinant human insulin like growth factor-1 (rhIGF-1) twice daily subcutaneously
1039372|NCT00720122|O1|Outcome|Anorexia Nervosa Females|Females aged 12 - 26 years Subjects received 30 mcg/kg/dose of recombinant human insulin like growth factor-1 (rhIGF-1) twice daily subcutaneously
1039373|NCT00720122|E1|Reported Event|Anorexia Nervosa Females|Females aged 12 - 26 years Subjects received 30 mcg/kg/dose of recombinant human insulin like growth factor-1 (rhIGF-1) twice daily subcutaneously
1039374|NCT00720109|B1|Baseline|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|"See Detailed Description~Asparaginase: Given IT~Cyclophosphamide: Given IV~Cytarabine: Given IT or IV~Dasatinib: Given PO~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Hydrocortisone Sodium Succinate: Given IT~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV or PO~Mercaptopurine: Given PO~Methotrexate: Given IT, PO, or IV~Methylprednisolone: Given IV~Pegaspargase: Given IM~Prednisone: Given PO or IV~Radiation Therapy: Some patients undergo cranial RT~Vincristine Sulfate: Given IV"
1039375|NCT00720109|P3|Participant Flow|High-risk|Based on Minimal Residual Disease, great than or equal to 1%.
1039376|NCT00720109|P2|Participant Flow|Standard-risk|Based on Minimal Residual Disease, less than 1%.
1039377|NCT00720109|P1|Participant Flow|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|"See Detailed Description~Asparaginase: Given IT~Cyclophosphamide: Given IV~Cytarabine: Given IT or IV~Dasatinib: Given PO~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Hydrocortisone Sodium Succinate: Given IT~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV or PO~Mercaptopurine: Given PO~Methotrexate: Given IT, PO, or IV~Methylprednisolone: Given IV~Pegaspargase: Given IM~Prednisone: Given PO or IV~Radiation Therapy: Some patients undergo cranial RT~Vincristine Sulfate: Given IV"
1039378|NCT00720109|O3|Outcome|High-risk|Based on Minimal Residual Disease, great than or equal to 1%.
1039379|NCT00720109|O2|Outcome|Standard-risk|Based on Minimal Residual Disease, less than 1%.
1039380|NCT00720109|O1|Outcome|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|"See Detailed Description~Asparaginase: Given IT~Cyclophosphamide: Given IV~Cytarabine: Given IT or IV~Dasatinib: Given PO~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Hydrocortisone Sodium Succinate: Given IT~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV or PO~Mercaptopurine: Given PO~Methotrexate: Given IT, PO, or IV~Methylprednisolone: Given IV~Pegaspargase: Given IM~Prednisone: Given PO or IV~Radiation Therapy: Some patients undergo cranial RT~Vincristine Sulfate: Given IV"
1039381|NCT00720109|O3|Outcome|High-risk|Based on Minimal Residual Disease, great than or equal to 1%.
1039382|NCT00720109|O2|Outcome|Standard-risk|Based on Minimal Residual Disease, less than 1%.
1039383|NCT00720109|O1|Outcome|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|"See Detailed Description~Asparaginase: Given IT~Cyclophosphamide: Given IV~Cytarabine: Given IT or IV~Dasatinib: Given PO~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Hydrocortisone Sodium Succinate: Given IT~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV or PO~Mercaptopurine: Given PO~Methotrexate: Given IT, PO, or IV~Methylprednisolone: Given IV~Pegaspargase: Given IM~Prednisone: Given PO or IV~Radiation Therapy: Some patients undergo cranial RT~Vincristine Sulfate: Given IV"
1039384|NCT00720109|O3|Outcome|High-risk|Based on Minimal Residual Disease, great than or equal to 1%.
1039385|NCT00720109|O2|Outcome|Standard-risk|Based on Minimal Residual Disease, less than 1%.
1039386|NCT00720109|O1|Outcome|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|"See Detailed Description~Asparaginase: Given IT~Cyclophosphamide: Given IV~Cytarabine: Given IT or IV~Dasatinib: Given PO~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Hydrocortisone Sodium Succinate: Given IT~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV or PO~Mercaptopurine: Given PO~Methotrexate: Given IT, PO, or IV~Methylprednisolone: Given IV~Pegaspargase: Given IM~Prednisone: Given PO or IV~Radiation Therapy: Some patients undergo cranial RT~Vincristine Sulfate: Given IV"
1039387|NCT00720109|O1|Outcome|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|Feasibility measured by DLT rates in safety phase, Toxicities define DLTs and are summarized and reviewed to assess feasibility of administering the combination therapy with dasatinib
1039388|NCT00720109|O3|Outcome|High-risk|Based on Minimal Residual Disease, great than or equal to 1%.
1039389|NCT00720109|O2|Outcome|Standard-risk|Based on Minimal Residual Disease, less than 1%.
1039390|NCT00720109|O1|Outcome|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|"See Detailed Description~Asparaginase: Given IT~Cyclophosphamide: Given IV~Cytarabine: Given IT or IV~Dasatinib: Given PO~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Hydrocortisone Sodium Succinate: Given IT~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV or PO~Mercaptopurine: Given PO~Methotrexate: Given IT, PO, or IV~Methylprednisolone: Given IV~Pegaspargase: Given IM~Prednisone: Given PO or IV~Radiation Therapy: Some patients undergo cranial RT~Vincristine Sulfate: Given IV"
1039391|NCT00720109|E3|Reported Event|High-risk|Based on Minimal Residual Disease, great than or equal to 1%.
1039392|NCT00720109|E2|Reported Event|Standard-risk|Based on Minimal Residual Disease, less than 1%.
1039393|NCT00720109|E1|Reported Event|Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)|"See Detailed Description~Asparaginase: Given IT~Cyclophosphamide: Given IV~Cytarabine: Given IT or IV~Dasatinib: Given PO~Daunorubicin Hydrochloride: Given IV~Dexamethasone: Given IV or PO~Etoposide: Given IV~Filgrastim: Given IV or SC~Hydrocortisone Sodium Succinate: Given IT~Ifosfamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV or PO~Mercaptopurine: Given PO~Methotrexate: Given IT, PO, or IV~Methylprednisolone: Given IV~Pegaspargase: Given IM~Prednisone: Given PO or IV~Radiation Therapy: Some patients undergo cranial RT~Vincristine Sulfate: Given IV"
1039394|NCT00720096|B3|Baseline|Total|Total of all reporting groups
1039395|NCT00720096|B2|Baseline|Topotecan|Topotecan - Chemotherapy single agent systemic.
1039396|NCT00720096|B1|Baseline|Liposomal Doxorubicin|Liposomal Doxorubicin - Chemotherapy single agent systemic.
1039397|NCT00720096|P2|Participant Flow|Topotecan|Topotecan - Chemotherapy single agent systemic.
1039398|NCT00720096|P1|Participant Flow|Liposomal Doxorubicin|Liposomal Doxorubicin - Chemotherapy single agent systemic.
1039399|NCT00720096|O2|Outcome|Topotecan|Topotecan - Chemotherapy single agent systemic.
1039400|NCT00720096|O1|Outcome|Liposomal Doxorubicin|Liposomal Doxorubicin - Chemotherapy single agent systemic.
1039401|NCT00720096|O2|Outcome|Topotecan|Topotecan - Chemotherapy single agent systemic.
1039402|NCT00720096|O1|Outcome|Liposomal Doxorubicin|Liposomal Doxorubicin - Chemotherapy single agent systemic.
1039403|NCT00720096|E2|Reported Event|Topotecan|Topotecan - Chemotherapy single agent systemic.
1039404|NCT00720096|E1|Reported Event|Liposomal Doxorubicin|Liposomal Doxorubicin - Chemotherapy single agent systemic.
1039405|NCT00720083|B3|Baseline|Total|Total of all reporting groups
1039406|NCT00720083|B2|Baseline|RT + Cisplatin + Vandetanib|Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
1039407|NCT00720083|B1|Baseline|RT + Cisplatin|Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
1039408|NCT00720083|P2|Participant Flow|RT + Cisplatin + Vandetanib|Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
1039409|NCT00720083|P1|Participant Flow|RT + Cisplatin|Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
1039410|NCT00720083|O2|Outcome|RT + Cisplatin + Vandetanib|Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
1039411|NCT00720083|O1|Outcome|RT + Cisplatin|Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
1039412|NCT00720083|E2|Reported Event|RT + Cisplatin + Vandetanib|Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
1039413|NCT00720083|E1|Reported Event|RT+ Cisplatin|Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
1039414|NCT00720057|B3|Baseline|Total|Total of all reporting groups
1039415|NCT00720057|B2|Baseline|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
1039416|NCT00720057|B1|Baseline|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
1039417|NCT00720057|P2|Participant Flow|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
1039418|NCT00720057|P1|Participant Flow|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
1039419|NCT00720057|O2|Outcome|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
1039420|NCT00720057|O1|Outcome|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
1053919|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
1039421|NCT00720057|O2|Outcome|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
1039527|NCT00719810|E3|Reported Event|Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h|
1039422|NCT00720057|O1|Outcome|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
1039423|NCT00720057|O2|Outcome|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
1039424|NCT00720057|O1|Outcome|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
1039425|NCT00720057|O2|Outcome|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
1039426|NCT00720057|O1|Outcome|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
1039427|NCT00720057|O2|Outcome|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
1039428|NCT00720057|O1|Outcome|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
1039429|NCT00720057|O2|Outcome|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
1039430|NCT00720057|O1|Outcome|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
1039431|NCT00720057|E2|Reported Event|Placebo|single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
1039432|NCT00720057|E1|Reported Event|Naproxen Sodium ER (BAYH6689)|single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
1039433|NCT00719953|B1|Baseline|Cognitex|Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks
1039434|NCT00719953|P1|Participant Flow|Cognitex|Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks
1039435|NCT00719953|O1|Outcome|Cognitex|Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks
1039436|NCT00719953|E1|Reported Event|Cognitex|Treatment will consist of one capsule of Cognitex (Life Extension, USA), three times a day, with meals, delivering a total of 600 mg GPC, 100 mg PS-omega 3, 20 mg vinpocetine, 50 mg uridine-5'-monophosphate (disodium), 550 mg plant extracts (150 mg wild blueberry, 125 mg ashwagandha, 150 mg grape seed, 125 mg hops, ginger and rosemary). Duration: 15 weeks
1039437|NCT00719914|B3|Baseline|Total|Total of all reporting groups
1039438|NCT00719914|B2|Baseline|Bolus of Normal Saline|Intra-coronary injection of normal saline.
1039439|NCT00719914|B1|Baseline|Additional Bolus of Eptifibatide|Intracoronary injection of eptifibatide
1039440|NCT00719914|P2|Participant Flow|Bolus of Normal Saline|Intracoronary injection of normal saline.
1039441|NCT00719914|P1|Participant Flow|Additional Bolus of Eptifibatide|Intracoronary injection of eptifibatide
1039442|NCT00719914|O2|Outcome|Bolus of Normal Saline|Intra-coronary injection of normal saline.
1039443|NCT00719914|O1|Outcome|Additional Bolus of Eptifibatide|Intracoronary injection of eptifibatide
1039444|NCT00719914|E2|Reported Event|Bolus of Normal Saline|Intra-coronary injection of normal saline.
1039445|NCT00719914|E1|Reported Event|Additional Bolus of Eptifibatide|Intracoronary injection of eptifibatide
1039446|NCT00719901|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1039447|NCT00719901|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1039448|NCT00719901|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1039449|NCT00719901|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1039450|NCT00719901|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1039451|NCT00719901|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1039452|NCT00719901|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1039453|NCT00719901|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1039454|NCT00719901|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1039521|NCT00719810|O3|Outcome|Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h|
1039522|NCT00719810|O2|Outcome|Delafloxacin 450 mg IV q12h|
1039528|NCT00719810|E2|Reported Event|Delafloxacin 450 mg IV q12h|
1039529|NCT00719810|E1|Reported Event|Delafloxacin 300 mg IV q12h|
1039455|NCT00719901|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1039456|NCT00719862|B3|Baseline|Total|Total of all reporting groups
1039457|NCT00719862|B2|Baseline|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
1039458|NCT00719862|B1|Baseline|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
1039459|NCT00719862|P2|Participant Flow|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
1039460|NCT00719862|P1|Participant Flow|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
1039461|NCT00719862|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
1039462|NCT00719862|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
1039463|NCT00719862|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
1039464|NCT00719862|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
1039465|NCT00719862|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
1039466|NCT00719862|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
1039467|NCT00719862|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
1039468|NCT00719862|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
1039469|NCT00719862|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
1039470|NCT00719862|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
1039471|NCT00719862|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
1039472|NCT00719862|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
1039473|NCT00719862|E2|Reported Event|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2sprays per nostril once daily for 14 days
1039474|NCT00719862|E1|Reported Event|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
1039475|NCT00719849|B3|Baseline|Total|Total of all reporting groups
1039476|NCT00719849|B2|Baseline|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months, and who should receive ATG as part of their conditioning regimen.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil"
1039477|NCT00719849|B1|Baseline|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR patients with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil"
1039478|NCT00719849|P2|Participant Flow|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months, and who should receive ATG as part of their conditioning regimen.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil"
1039479|NCT00719849|P1|Participant Flow|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR patients with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil"
1039480|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039481|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039482|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039483|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039484|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039523|NCT00719810|O1|Outcome|Delafloxacin 300 mg IV q12h|
1039524|NCT00719810|O3|Outcome|Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h|
1039485|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039486|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039487|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039488|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039489|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039490|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039491|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039492|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039493|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039494|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039495|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039496|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039497|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039498|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039499|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039525|NCT00719810|O2|Outcome|Delafloxacin 450 mg IV q12h|
1039526|NCT00719810|O1|Outcome|Delafloxacin 300 mg IV q12h|
1039500|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039501|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039502|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039503|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039504|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039505|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039506|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039507|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039508|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039509|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039510|NCT00719849|O2|Outcome|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039511|NCT00719849|O1|Outcome|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039512|NCT00719849|E2|Reported Event|Cyclophosphamide/Fludarabine/TBI/ATG|"Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day –1~Equine ATG 30mg/Kg Days –6 to -4~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039513|NCT00719849|E1|Reported Event|Cyclophosphamide/Fludarabine/TBI|"Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.~Cyclophosphamide 50 mg/Kg Day –6~Fludarabine 40mg/m2 Days –6 to –2~TBI 200 cGy Day -1~Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil"
1039514|NCT00719810|B4|Baseline|Total|Total of all reporting groups
1039515|NCT00719810|B3|Baseline|Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h|
1039516|NCT00719810|B2|Baseline|Delafloxacin 450 mg IV q12h|
1039517|NCT00719810|B1|Baseline|Delafloxacin 300 mg IV q12h|
1039518|NCT00719810|P3|Participant Flow|Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h|
1039519|NCT00719810|P2|Participant Flow|Delafloxacin 450 mg IV q12h|
1039520|NCT00719810|P1|Participant Flow|Delafloxacin 300 mg IV q12h|
1053920|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
1039530|NCT00719732|B1|Baseline|ReSTOR Aspheric +3|Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
1039531|NCT00719732|P1|Participant Flow|ReSTOR Aspheric +3|Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
1039532|NCT00719732|O1|Outcome|ReSTOR Aspheric +3|Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
1039533|NCT00719732|E1|Reported Event|ReSTOR Aspheric +3|Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
1039534|NCT00719706|B3|Baseline|Total|Total of all reporting groups
1039535|NCT00719706|B2|Baseline|Placebo|Participants taking placebo.
1039536|NCT00719706|B1|Baseline|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
1039537|NCT00719706|P2|Participant Flow|Placebo|Participants taking placebo.
1039538|NCT00719706|P1|Participant Flow|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
1039539|NCT00719706|O2|Outcome|Placebo|Participants taking placebo.
1039540|NCT00719706|O1|Outcome|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
1039541|NCT00719706|O2|Outcome|Placebo|Participants taking placebo.
1039542|NCT00719706|O1|Outcome|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
1039543|NCT00719706|O2|Outcome|Placebo|Participants taking placebo.
1039544|NCT00719706|O1|Outcome|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
1039545|NCT00719706|O2|Outcome|Placebo|Participants taking placebo.
1039546|NCT00719706|O1|Outcome|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
1039547|NCT00719706|O2|Outcome|Placebo|Participants taking placebo.
1039548|NCT00719706|O1|Outcome|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
1039549|NCT00719706|E2|Reported Event|Placebo|Participants taking placebo.
1039550|NCT00719706|E1|Reported Event|ALCAR/ALA|Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
1039551|NCT00719680|B1|Baseline|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject’s preference.
1039552|NCT00719680|P1|Participant Flow|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject’s preference.
1039553|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
1039554|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
1039555|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
1039556|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
1039557|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
1039558|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
1039559|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
1039560|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
1039561|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
1039562|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
1039563|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
1039564|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
1039565|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
1039645|NCT00719355|E1|Reported Event|Walking With Poles|Patients exercised using walking poles, 3 times weekly for 24 weeks.
1039566|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
1039567|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
1039568|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
1039569|NCT00719680|O1|Outcome|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject's preference.
1039570|NCT00719680|E1|Reported Event|IgPro20|A liquid formulation of normal human IgG at a concentration of 20%. IgPro20 was administered as a subcutaneous infusion weekly or twice weekly, depending on the investigator's judgment and the subject’s preference.
1039571|NCT00719615|B4|Baseline|Total|Total of all reporting groups
1039572|NCT00719615|B3|Baseline|Active Thyroid Cancer|
1039573|NCT00719615|B2|Baseline|Thyroid Cancer in Remission|
1039574|NCT00719615|B1|Baseline|Thyroid Nodules|
1039575|NCT00719615|P3|Participant Flow|Active Thyroid Cancer|
1039576|NCT00719615|P2|Participant Flow|Thyroid Cancer in Remission|
1039577|NCT00719615|P1|Participant Flow|Thyroid Nodules|
1039578|NCT00719615|O3|Outcome|Active Thyroid Cancer|
1039579|NCT00719615|O2|Outcome|Thyroid Cancer in Remission|
1039580|NCT00719615|O1|Outcome|Thyroid Nodules|
1039581|NCT00719615|E3|Reported Event|Active Thyroid Cancer|
1039582|NCT00719615|E2|Reported Event|Thyroid Cancer in Remission|
1039583|NCT00719615|E1|Reported Event|Thyroid Nodules|
1039584|NCT00719563|B3|Baseline|Total|Total of all reporting groups
1039585|NCT00719563|B2|Baseline|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
1039586|NCT00719563|B1|Baseline|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
1039587|NCT00719563|P2|Participant Flow|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
1039588|NCT00719563|P1|Participant Flow|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
1039589|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
1039590|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
1039591|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
1039592|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
1039593|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
1039594|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
1039595|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
1039596|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
1039597|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
1039598|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
1039599|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
1039600|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
1039601|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
1039602|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
1039603|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
1039604|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
1039605|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
1039606|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
1039607|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
1039608|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
1039646|NCT00719329|B4|Baseline|Total|Total of all reporting groups
1039609|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
1039610|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
1039611|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment..
1039612|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
1039613|NCT00719563|O2|Outcome|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
1039614|NCT00719563|O1|Outcome|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
1039615|NCT00719563|E2|Reported Event|Placebo|Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
1039616|NCT00719563|E1|Reported Event|Ginseng|Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
1039617|NCT00719537|B3|Baseline|Total|Total of all reporting groups
1039618|NCT00719537|B2|Baseline|Aspirin and Progesterone|aspirin 81 mg once a day oral progesterone 200mg twice daily
1039619|NCT00719537|B1|Baseline|Aspirin and Placebo|Aspirin and placebo: Aspirin 81mg once daily and placebo once daily
1039620|NCT00719537|P2|Participant Flow|Aspirin and Progesterone|aspirin 81 mg once a day oral progesterone 200mg twice daily
1039621|NCT00719537|P1|Participant Flow|Aspirin and Placebo|Aspirin and placebo: Aspirin 81mg once daily and placebo once daily
1039622|NCT00719537|O2|Outcome|Aspirin and Progesterone|aspirin 81 mg once a day oral progesterone 200mg twice daily
1039623|NCT00719537|O1|Outcome|Aspirin and Placebo|Aspirin and placebo: Aspirin 81mg once daily and placebo once daily
1039624|NCT00719537|E2|Reported Event|Aspirin and Progesterone|Aspirin and progesterone: aspirin 81 mg once a day oral progesterone 200mg twice daily
1039625|NCT00719537|E1|Reported Event|Aspirin and Placebo|Aspirin and placebo: Aspirin 81mg once daily and placebo
1039626|NCT00719472|B1|Baseline|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
1039627|NCT00719472|P1|Participant Flow|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
1039628|NCT00719472|O1|Outcome|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
1039629|NCT00719472|O1|Outcome|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
1039630|NCT00719472|O1|Outcome|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
1039631|NCT00719472|O1|Outcome|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
1039632|NCT00719472|O1|Outcome|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
1039633|NCT00719472|O1|Outcome|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
1039634|NCT00719472|E1|Reported Event|Rituximab 375 mg/m^2|Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
1039635|NCT00719355|B3|Baseline|Total|Total of all reporting groups
1039636|NCT00719355|B2|Baseline|Traditional Walking Group|Patients exercised for 24 weeks as part of a traditional walking training group.
1039637|NCT00719355|B1|Baseline|Walking With Poles|Patients exercised using walking poles, 3 times weekly for 24 weeks.
1039638|NCT00719355|P2|Participant Flow|Traditional Walking Group|Patients exercised for 24 weeks as part of a traditional walking training group.
1039639|NCT00719355|P1|Participant Flow|Walking With Poles|Patients exercised using walking poles, 3 times weekly for 24 weeks.
1039640|NCT00719355|O2|Outcome|Traditional Walking Group|Patients exercised for 24 weeks as part of a traditional walking training group.
1039641|NCT00719355|O1|Outcome|Walking With Poles|Patients exercised using walking poles, 3 times weekly for 24 weeks.
1039642|NCT00719355|O2|Outcome|Traditional Walking Group|Patients exercised for 24 weeks as part of a traditional walking training group.
1039643|NCT00719355|O1|Outcome|Walking With Poles|Patients exercised using walking poles, 3 times weekly for 24 weeks.
1039644|NCT00719355|E2|Reported Event|Traditional Walking Group|Patients exercised for 24 weeks as part of a traditional walking training group.
1053921|NCT00684307|O5|Outcome|VKA INR 2-3|
1039647|NCT00719329|B3|Baseline|Dry Cord Care|Dry cord care, as recommended by WHO
1039648|NCT00719329|B2|Baseline|CHX Cleansing - 1 Day|Chlorhexidine cleansing of the cord for 1 day
1039649|NCT00719329|B1|Baseline|CHX Cleansing - 7 Days|Chlorhexidine cleansing of the cord for seven days
1039650|NCT00719329|P3|Participant Flow|Dry Cord Care|Dry cord care, as recommended by WHO
1039651|NCT00719329|P2|Participant Flow|CHX Cleansing - 1 Day|Chlorhexidine cleansing of the cord for 1 day
1039652|NCT00719329|P1|Participant Flow|CHX Cleansing - 7 Days|Chlorhexidine cleansing of the cord for seven days
1039653|NCT00719329|O3|Outcome|Dry Cord Care|Babies in this group were born in clusters allocated to 0 days of chlorhexidine cleansing of the cord
1039654|NCT00719329|O2|Outcome|CHX Cleansing - 1 Day|Babies in this group were born in clusters allocated to 1 days of chlorhexidine cleansing of the cord
1039655|NCT00719329|O1|Outcome|CHX Cleansing - 7 Days|Babies in this group were born in clusters allocated to 7 days of chlorhexidine cleansing of the cord
1039656|NCT00719329|O3|Outcome|Dry Cord Care|Babies in this group were born in clusters allocated to 0 days of chlorhexidine cleansing of the cord
1039657|NCT00719329|O2|Outcome|CHX Cleansing - 1 Day|Babies in this group were born in clusters allocated to 1 days of chlorhexidine cleansing of the cord
1039658|NCT00719329|O1|Outcome|CHX Cleansing - 7 Days|Babies in this group were born in clusters allocated to 7 days of chlorhexidine cleansing of the cord
1039659|NCT00719329|O3|Outcome|Dry Cord Care|Babies in this group were born in clusters allocated to 0 days of chlorhexidine cleansing to the cord
1039660|NCT00719329|O2|Outcome|CHX Cleansing - 1 Day|Babies in this group were born in clusters allocated to 1 days of chlorhexidine cleansing to the cord
1039661|NCT00719329|O1|Outcome|CHX Cleansing - 7 Days|Babies in this group were born in clusters allocated to 7 days of chlorhexidine cleansing to the cord
1039662|NCT00719329|E3|Reported Event|Dry Cord Care|Dry cord care, as recommended by WHO
1039663|NCT00719329|E2|Reported Event|CHX Cleansing - 1 Day|Chlorhexidine cleansing of the cord for 1 day
1039664|NCT00719329|E1|Reported Event|CHX Cleansing - 7 Days|Chlorhexidine cleansing of the cord for seven days
1039665|NCT00719264|B3|Baseline|Total|Total of all reporting groups
1039666|NCT00719264|B2|Baseline|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
1039667|NCT00719264|B1|Baseline|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
1039668|NCT00719264|P2|Participant Flow|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
1039669|NCT00719264|P1|Participant Flow|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
1039670|NCT00719264|O1|Outcome|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
1039671|NCT00719264|O2|Outcome|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
1039672|NCT00719264|O1|Outcome|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
1039673|NCT00719264|O2|Outcome|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
1039674|NCT00719264|O1|Outcome|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
1039675|NCT00719264|O2|Outcome|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
1039676|NCT00719264|O1|Outcome|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
1039677|NCT00719264|O2|Outcome|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
1039678|NCT00719264|O1|Outcome|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
1039679|NCT00719264|O2|Outcome|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
1039680|NCT00719264|O1|Outcome|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
1039681|NCT00719264|O2|Outcome|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
1039682|NCT00719264|O1|Outcome|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
1039683|NCT00719264|O2|Outcome|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
1039684|NCT00719264|O1|Outcome|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
1039713|NCT00719160|P2|Participant Flow|Intervention Placebo First/Esomeprazole Second|In this group this group received the placebo first and then the intervention
1040735|NCT00716092|O2|Outcome|BI1356|Patients randomized to receive treatment with BI1356 5 mg
1039685|NCT00719264|E2|Reported Event|Bevacizumab, Interferon Alfa-2a (IFN)|Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
1039686|NCT00719264|E1|Reported Event|Bevacizumab, RAD001 (Everolimus)|Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
1039687|NCT00719212|B1|Baseline|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
1039688|NCT00719212|P1|Participant Flow|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
1039689|NCT00719212|O1|Outcome|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
1039690|NCT00719212|O1|Outcome|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
1039691|NCT00719212|O1|Outcome|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
1039692|NCT00719212|O1|Outcome|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
1039693|NCT00719212|O1|Outcome|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
1039694|NCT00719212|O1|Outcome|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
1039695|NCT00719212|O1|Outcome|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
1039696|NCT00719212|E1|Reported Event|AMG 479|"AMG 479 administered on day 1 of each 21-day cycle up to disease progression, unacceptable toxicity, withdrawal of consent or sponsor decision to stop the study.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
1039697|NCT00719186|B3|Baseline|Total|Total of all reporting groups
1039698|NCT00719186|B2|Baseline|Arm B: Letrozole|"Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
1039699|NCT00719186|B1|Baseline|Arm A: Clomiphene Citrate|"Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
1039700|NCT00719186|P2|Participant Flow|Arm B: Letrozole|"Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
1039701|NCT00719186|P1|Participant Flow|Arm A: Clomiphene Citrate|"Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
1039702|NCT00719186|O2|Outcome|Arm B: Letrozole|"Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
1039703|NCT00719186|O1|Outcome|Arm A: Clomiphene Citrate|"Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
1039704|NCT00719186|O2|Outcome|Arm B: Letrozole|"Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
1039705|NCT00719186|O1|Outcome|Arm A: Clomiphene Citrate|"Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
1039706|NCT00719186|O2|Outcome|Arm B: Letrozole|"Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
1039707|NCT00719186|O1|Outcome|Arm A: Clomiphene Citrate|"Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
1039708|NCT00719186|O2|Outcome|Arm B: Letrozole|"Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
1039709|NCT00719186|O1|Outcome|Arm A: Clomiphene Citrate|"Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
1039710|NCT00719186|E2|Reported Event|Arm B: Letrozole|"Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Letrozole: Letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
1039711|NCT00719186|E1|Reported Event|Arm A: Clomiphene Citrate|"Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks~Clomiphene citrate: Clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks"
1039712|NCT00719160|B1|Baseline|Entire Study Population|Includes groups randomized to receive 20 mg twice daily of either placebo or esomeprazole first
1039714|NCT00719160|P1|Participant Flow|Intervention Esomeprazole First/Placebo Second|In this group this group received the intervention first and then the placebo
1039715|NCT00719160|O2|Outcome|Placebo|Placebo 20 mg twice a day given as either the first or second intervention.
1039716|NCT00719160|O1|Outcome|Esomeprazole Study Drug|Esomeprazole 20 mg twice daily given as either the first or second intervention
1039717|NCT00719160|O2|Outcome|Placebo|Placebo administered twice daily in either first or second intervention
1039718|NCT00719160|O1|Outcome|Esomeprazole|Esomeprazoled administered twice daily in either first or second intervention period
1039719|NCT00719160|E1|Reported Event|Entire Study Population|Includes groups randomized to receive 20 mg twice daily of either placebo or esomeprazole first
1039720|NCT00719134|B1|Baseline|All Participants|76 subjects were randomized to 8 different treatment sequences. Each sequience included treating 6 attacks. 66 subjects completed their treatment assignment.
1039721|NCT00719134|P1|Participant Flow|All Participants|76 subjects were randomized to 8 different treatment sequences. Each sequience included treating 6 attacks. 66 subjects completed their treatment assignment.
1039722|NCT00719134|O1|Outcome|All Participants|
1039723|NCT00719134|O1|Outcome|All Participants|
1039724|NCT00719134|E2|Reported Event|Placebo|
1039725|NCT00719134|E1|Reported Event|Maxalt|
1039726|NCT00719043|B8|Baseline|Total|Total of all reporting groups
1039727|NCT00719043|B7|Baseline|Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
1039728|NCT00719043|B6|Baseline|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039729|NCT00719043|B5|Baseline|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039730|NCT00719043|B4|Baseline|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039731|NCT00719043|B3|Baseline|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039732|NCT00719043|B2|Baseline|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039733|NCT00719043|B1|Baseline|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039734|NCT00719043|P7|Participant Flow|Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
1039881|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
1053922|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
1040022|NCT00718302|E2|Reported Event|Lateral Plate|A metal plate is placed to the side of the broken ankle and is secured with screws
1039735|NCT00719043|P6|Participant Flow|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039736|NCT00719043|P5|Participant Flow|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039737|NCT00719043|P4|Participant Flow|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039738|NCT00719043|P3|Participant Flow|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039739|NCT00719043|P2|Participant Flow|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039740|NCT00719043|P1|Participant Flow|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039741|NCT00719043|O1|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
1039742|NCT00719043|O6|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039743|NCT00719043|O5|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039744|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039745|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039882|NCT00718887|O2|Outcome|Adefovir, 10 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
1039883|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD) for a maximum of 52 weeks.
1039746|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039747|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039748|NCT00719043|O5|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
1039749|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039750|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039751|NCT00719043|O2|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039752|NCT00719043|O1|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039753|NCT00719043|O3|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
1039754|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039755|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039756|NCT00719043|O5|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
1039757|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039884|NCT00718887|E2|Reported Event|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
1039885|NCT00718887|E1|Reported Event|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
1039758|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039759|NCT00719043|O2|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039760|NCT00719043|O1|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039761|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039762|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039763|NCT00719043|O1|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
1039764|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039765|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039766|NCT00719043|O2|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039767|NCT00719043|O1|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039768|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039769|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039770|NCT00719043|O1|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
1039771|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039772|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039773|NCT00719043|O2|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039774|NCT00719043|O1|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039775|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039776|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039777|NCT00719043|O3|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
1039778|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039779|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039780|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039781|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039782|NCT00719043|O2|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039783|NCT00719043|O1|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039784|NCT00719043|O7|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
1039785|NCT00719043|O6|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039786|NCT00719043|O5|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039787|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039788|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039789|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039790|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039791|NCT00719043|O7|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
1039792|NCT00719043|O6|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039793|NCT00719043|O5|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039794|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039795|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039796|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039797|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039798|NCT00719043|O7|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
1039799|NCT00719043|O6|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039800|NCT00719043|O5|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039801|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039802|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039803|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039804|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039805|NCT00719043|O7|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
1039806|NCT00719043|O6|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039807|NCT00719043|O5|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039808|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039809|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039810|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039811|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039812|NCT00719043|O7|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
1039813|NCT00719043|O6|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039814|NCT00719043|O5|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039815|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039816|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039817|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039818|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039819|NCT00719043|O1|Outcome|Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
1039820|NCT00719043|O4|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039821|NCT00719043|O3|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039886|NCT00718861|B3|Baseline|Total|Total of all reporting groups
1039916|NCT00718809|B2|Baseline|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1039822|NCT00719043|O2|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039823|NCT00719043|O1|Outcome|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039824|NCT00719043|O5|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
1039825|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039826|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039827|NCT00719043|O2|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039828|NCT00719043|O1|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039829|NCT00719043|O3|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
1039830|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039831|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039832|NCT00719043|O3|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
1039833|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039887|NCT00718861|B2|Baseline|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
1039834|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039835|NCT00719043|O4|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039836|NCT00719043|O3|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039837|NCT00719043|O2|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039838|NCT00719043|O1|Outcome|Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039839|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039840|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039841|NCT00719043|O2|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039842|NCT00719043|O1|Outcome|Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039843|NCT00719043|O1|Outcome|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
1039844|NCT00719043|O1|Outcome|Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
1039845|NCT00719043|O4|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039888|NCT00718861|B1|Baseline|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
1040018|NCT00718302|O2|Outcome|Lateral Plate|A metal plate is placed to the side of the broken ankle and is secured with screws
1039846|NCT00719043|O3|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039847|NCT00719043|O2|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039848|NCT00719043|O1|Outcome|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039849|NCT00719043|O1|Outcome|Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
1039850|NCT00719043|O4|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039851|NCT00719043|O3|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039852|NCT00719043|O2|Outcome|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039853|NCT00719043|O1|Outcome|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039854|NCT00719043|E7|Reported Event|Naïve Placebo-A/Turkey H5N1-Formulation 3 Group|Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
1039855|NCT00719043|E6|Reported Event|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039856|NCT00719043|E5|Reported Event|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1040019|NCT00718302|O1|Outcome|Antiglide Plate|A plate is placed behind the broken ankle and secured with screws
1039857|NCT00719043|E4|Reported Event|A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039858|NCT00719043|E3|Reported Event|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039859|NCT00719043|E2|Reported Event|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039860|NCT00719043|E1|Reported Event|A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group|Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
1039861|NCT00718887|B3|Baseline|Total|Total of all reporting groups
1039862|NCT00718887|B2|Baseline|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
1039863|NCT00718887|B1|Baseline|Entecavir, 0.5 mg QD|Participants with a pervious suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
1039864|NCT00718887|P2|Participant Flow|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
1039865|NCT00718887|P1|Participant Flow|Entecavir, 0.5 mg QD|Participants with a pervious suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
1039866|NCT00718887|O2|Outcome|Adefovir, 10 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
1039867|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
1039868|NCT00718887|O2|Outcome|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
1039869|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
1039870|NCT00718887|O2|Outcome|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
1039871|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
1039872|NCT00718887|O2|Outcome|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
1039873|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
1039874|NCT00718887|O2|Outcome|Adefovir, 10 mg QD/Entecavir, 10 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
1039875|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a pervious suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
1039876|NCT00718887|O2|Outcome|Adeforvi, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
1039877|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
1039878|NCT00718887|O2|Outcome|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
1039879|NCT00718887|O1|Outcome|Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
1039880|NCT00718887|O2|Outcome|Adefovir, 10 mg QD/Entecavir, 0.5 mg QD|Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
1040732|NCT00716092|O2|Outcome|BI1356|Patients randomized to receive treatment with BI1356 5 mg
1039889|NCT00718861|P2|Participant Flow|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
1039890|NCT00718861|P1|Participant Flow|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
1039891|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
1039892|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
1039893|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
1039894|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
1039895|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
1039896|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
1039897|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
1039898|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
1039899|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
1039900|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
1039901|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
1039902|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
1039903|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
1039904|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
1039905|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
1039906|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
1039907|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
1039908|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
1039909|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
1039910|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
1039911|NCT00718861|O2|Outcome|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
1039912|NCT00718861|O1|Outcome|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
1039913|NCT00718861|E2|Reported Event|Z6P3 (Zoledronic Acid 6 Placebo 3)|Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
1039914|NCT00718861|E1|Reported Event|Z9 (Zoledronic Acid 9)|Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
1039915|NCT00718809|B3|Baseline|Total|Total of all reporting groups
1040020|NCT00718302|O2|Outcome|Lateral Plate|A metal plate is placed to the side of the broken ankle and is secured with screws
1039917|NCT00718809|B1|Baseline|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1039918|NCT00718809|P2|Participant Flow|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1039919|NCT00718809|P1|Participant Flow|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1039920|NCT00718809|O2|Outcome|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1039921|NCT00718809|O1|Outcome|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1039922|NCT00718809|O2|Outcome|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1039923|NCT00718809|O1|Outcome|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1039924|NCT00718809|O2|Outcome|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1039925|NCT00718809|O1|Outcome|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1039926|NCT00718809|O2|Outcome|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1039927|NCT00718809|O1|Outcome|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1039928|NCT00718809|O2|Outcome|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1039929|NCT00718809|O1|Outcome|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1039930|NCT00718809|E2|Reported Event|Thymic Carcinoma|Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1039931|NCT00718809|E1|Reported Event|Thymoma|Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1039932|NCT00718770|B1|Baseline|Bexarotene|"Open label - all patients receive intervention~Bexarotene : Bexarotene will be given by mouth once a day every day for 1 year. The dose to be used will be 300 mg/m2."
1039933|NCT00718770|P1|Participant Flow|Bexarotene|"Open label - all patients received the intervention~Bexarotene : Bexarotene was given by mouth once a day every day for 1 year. The dose used was 300 mg/m2."
1039934|NCT00718770|O1|Outcome|Bexarotene|"Open label - all patients receive intervention~Bexarotene : Bexarotene will be given by mouth once a day every day for 1 year. The dose to be used will be 300 mg/m2."
1039935|NCT00718770|E1|Reported Event|Bexarotene|"Open label - all patients receive intervention~Bexarotene : Bexarotene will be given by mouth once a day every day for 1 year. The dose to be used will be 300 mg/m2."
1039936|NCT00718640|B1|Baseline|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
1039937|NCT00718640|P1|Participant Flow|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
1039938|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
1039939|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
1040021|NCT00718302|O1|Outcome|Antiglide Plate|A plate is placed behind the broken ankle and secured with screws
1039940|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
1039941|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
1039942|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
1039943|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
1039944|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
1039945|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
1039946|NCT00718640|O1|Outcome|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
1039947|NCT00718640|E1|Reported Event|Bortezomib and Dexamethasone|Bortezomib 1.3 milligram (mg) per meter^2 (m^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator’s discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).
1039948|NCT00718523|B3|Baseline|Total|Total of all reporting groups
1039949|NCT00718523|B2|Baseline|B Experimental|"AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
1039950|NCT00718523|B1|Baseline|A Control|"Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.~AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle."
1039951|NCT00718523|P2|Participant Flow|B Experimental|"AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
1039952|NCT00718523|P1|Participant Flow|A Control|"Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.~AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle."
1039953|NCT00718523|O2|Outcome|B Experimental|"AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
1039954|NCT00718523|O1|Outcome|A Control|"Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.~AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle."
1039955|NCT00718523|O2|Outcome|B Experimental|"AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
1039956|NCT00718523|O1|Outcome|A Control|"Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.~AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle."
1039957|NCT00718523|O2|Outcome|B Experimental|"AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
1039958|NCT00718523|O1|Outcome|A Control|"Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.~AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle."
1039959|NCT00718523|E2|Reported Event|B Experimental|"AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.~AMG 479: Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle"
1039960|NCT00718523|E1|Reported Event|A Control|"Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.~AMG 479 Placebo: Matching placebo administered Day 1 of each 21 day cycle."
1039961|NCT00718328|B3|Baseline|Total|Total of all reporting groups
1039962|NCT00718328|B2|Baseline|Placebo Group|Placebo: Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.
1039963|NCT00718328|B1|Baseline|Simvastatin Group|Simvastatin 80 mg: Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.
1039964|NCT00718328|P2|Participant Flow|Placebo Group|Placebo: Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.
1039965|NCT00718328|P1|Participant Flow|Simvastatin Group|Simvastatin 80 mg: Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.
1039966|NCT00718328|O2|Outcome|Placebo Group|Placebo: Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.
1039967|NCT00718328|O1|Outcome|Simvastatin Group|Simvastatin 80 mg: Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.
1039968|NCT00718328|E2|Reported Event|Placebo Group|Placebo: Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.
1039969|NCT00718328|E1|Reported Event|Simvastatin Group|Simvastatin 80 mg: Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.
1039970|NCT00718315|B4|Baseline|Total|Total of all reporting groups
1039971|NCT00718315|B3|Baseline|Verutex|Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
1039972|NCT00718315|B2|Baseline|Stiemicyn|Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
1039973|NCT00718315|B1|Baseline|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
1039974|NCT00718315|P3|Participant Flow|Verutex|Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
1039975|NCT00718315|P2|Participant Flow|Stiemicyn|Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
1039976|NCT00718315|P1|Participant Flow|Fisiogel|Participants received erlotinib 150 milligrams (mg) daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
1039977|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
1039978|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
1039979|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
1039980|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
1039981|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
1039982|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
1039983|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
1039984|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
1039985|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
1039986|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
1039987|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
1039988|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
1039989|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
1039990|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
1039991|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
1039992|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
1039993|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
1039994|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
1039995|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
1039996|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
1039997|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
1039998|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
1039999|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
1040000|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
1040001|NCT00718315|O3|Outcome|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
1040002|NCT00718315|O2|Outcome|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
1040003|NCT00718315|O1|Outcome|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
1040004|NCT00718315|E3|Reported Event|Verutex|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days
1040005|NCT00718315|E2|Reported Event|Stiemicyn|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
1040006|NCT00718315|E1|Reported Event|Fisiogel|Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days.
1040007|NCT00718302|B3|Baseline|Total|Total of all reporting groups
1040008|NCT00718302|B2|Baseline|Lateral Plate|A metal plate is placed to the side of the broken ankle and is secured with screws
1040009|NCT00718302|B1|Baseline|Antiglide Plate|A plate is placed behind the broken ankle and secured with screws.
1040010|NCT00718302|P2|Participant Flow|Lateral Plate|Lateral Plate: A metal plate is placed to the side of the broken ankle and is secured with screws
1040011|NCT00718302|P1|Participant Flow|Antiglide Plate|Antiglide Plate: A plate is placed behind the broken ankle and secured with screws
1040012|NCT00718302|O2|Outcome|Randomized Treatment; Lateral Plate|"Randomized treatment; lateral plate~Lateral Plate: A metal plate is placed to the side of the broken ankle and is secured with screws"
1040013|NCT00718302|O1|Outcome|Randomized Treatment; Antiglide Plate|"Randomized treatment; antiglide plate~Antiglide Plate: A plate is placed behind the broken ankle and secured with screws"
1040014|NCT00718302|O2|Outcome|Lateral Plate|A metal plate is placed to the side of the broken ankle and is secured with screws
1040015|NCT00718302|O1|Outcome|Antiglide Plate|A plate is placed behind the broken ankle and secured with screws
1040016|NCT00718302|O2|Outcome|Lateral Plate|A metal plate is placed to the side of the broken ankle and is secured with screws
1040017|NCT00718302|O1|Outcome|Antiglide Plate|A plate is placed behind the broken ankle and secured with screws
1040023|NCT00718302|E1|Reported Event|Antiglide Plate|A plate is placed behind the broken ankle and secured with screws
1040024|NCT00718237|B3|Baseline|Total|Total of all reporting groups
1040025|NCT00718237|B2|Baseline|Placebo|Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
1040026|NCT00718237|B1|Baseline|RotaTeq™|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
1040027|NCT00718237|P2|Participant Flow|Placebo|Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
1040028|NCT00718237|P1|Participant Flow|RotaTeq™|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
1040029|NCT00718237|O2|Outcome|Placebo|Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study
1040030|NCT00718237|O1|Outcome|RotaTeq™|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
1040031|NCT00718237|O2|Outcome|Placebo|Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
1040032|NCT00718237|O1|Outcome|RotaTeq™|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
1040033|NCT00718237|O2|Outcome|Placebo|Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
1040034|NCT00718237|O1|Outcome|RotaTeq™|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
1040035|NCT00718237|E2|Reported Event|Placebo|Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
1040036|NCT00718237|E1|Reported Event|RotaTeq™|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
1040037|NCT00718120|B3|Baseline|Total|Total of all reporting groups
1040038|NCT00718120|B2|Baseline|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
1040039|NCT00718120|B1|Baseline|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
1040040|NCT00718120|P2|Participant Flow|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
1040041|NCT00718120|P1|Participant Flow|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
1040042|NCT00718120|O2|Outcome|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
1040043|NCT00718120|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
1040044|NCT00718120|O2|Outcome|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
1040045|NCT00718120|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
1040046|NCT00718120|O2|Outcome|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
1040047|NCT00718120|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
1040048|NCT00718120|O2|Outcome|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
1040049|NCT00718120|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
1040050|NCT00718120|O2|Outcome|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
1040051|NCT00718120|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
1040052|NCT00718120|O2|Outcome|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
1040053|NCT00718120|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
1040054|NCT00718120|O2|Outcome|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
1040055|NCT00718120|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
1040056|NCT00718120|E2|Reported Event|Fluviral Elderly Group|Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
1040057|NCT00718120|E1|Reported Event|Fluviral Adult Group|Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
1040058|NCT00718081|B4|Baseline|Total|Total of all reporting groups
1040059|NCT00718081|B3|Baseline|Placebo NanoTab|
1040060|NCT00718081|B2|Baseline|Sufentanil NanoTab 15 mcg|
1040061|NCT00718081|B1|Baseline|Sufentanil NanoTab 10 mcg|
1040062|NCT00718081|P3|Participant Flow|Placebo NanoTab|
1040063|NCT00718081|P2|Participant Flow|Sufentanil NanoTab 15 mcg|
1040064|NCT00718081|P1|Participant Flow|Sufentanil NanoTab 10 mcg|
1040065|NCT00718081|O3|Outcome|Placebo NanoTab|
1040066|NCT00718081|O2|Outcome|Sufentanil NanoTab 15 mcg|
1040067|NCT00718081|O1|Outcome|Sufentanil NanoTab 10 mcg|
1040068|NCT00718081|O3|Outcome|Placebo NanoTab|
1040075|NCT00718042|B6|Baseline|Chagas Extended Evaluation|All subject's blood tested by the investigational Chagas screening test.
1040076|NCT00718042|B5|Baseline|Sensitivity Chagas Parasitology Positive Specimens|Specimen collected in South/Central America under separate specimen collection protocols were tested with investigational Chagas screening assay and with ESA Chagas.
1040077|NCT00718042|B4|Baseline|ESA Chagas Specificity|US blood donor specimen presumed antibody negative for T cruzi antibody were tested with investigational ESA Chagas.
1040078|NCT00718042|B3|Baseline|Reactivity in Chagas Endemic Population|Specimen collected in Chagas endemic area in South/Central America (524) under separate specimen collection protocol were tested with investigational Chagas screening assay and with the Chagas Confirmatory assay.
1040079|NCT00718042|B2|Baseline|Reactivity T Cruzi Antibody Positive|Specimen antibody positive for T cruzi antibody collected in South America (85) under separate specimen collection protocols and unidentified US blood donor specimens (202) were tested with investigational Chagas screening assay and with the Chagas confirmatory assay.
1040080|NCT00718042|B1|Baseline|ABBOTT PRISM Chagas Specificity|All subject's blood tested by the investigational Chagas screening test.
1040081|NCT00718042|P6|Participant Flow|ESA Chagas Specificity|US blood donor specimen presumed antibody negative for T cruzi antibody were tested with investigational ESA Chagas.
1040082|NCT00718042|P5|Participant Flow|Chagas Extended Evaluation|US blood donor specimen were tested with investigational Chagas screening assay to identify repeatedly reactive specimens.
1040083|NCT00718042|P4|Participant Flow|Sensitivity Chagas Parasitology Positive Specimens|Specimen collected in South/Central America under separate specimen collection protocols were tested with investigational Chagas screening assay and with ESA Chagas.
1040084|NCT00718042|P3|Participant Flow|Reactivity in Chagas Endemic Population|Specimen collected in Chagas endemic area in South/Central America (524) under separate specimen collection protocol were tested with investigational Chagas screening assay and with the Chagas Confirmatory assay.
1040085|NCT00718042|P2|Participant Flow|Reactivity T Cruzi Antibody Positive|Specimen antibody positive for T cruzi antibody collected in South America (85) under separate specimen collection protocols and unidentified US blood donor specimens (202) were tested with investigational Chagas screening assay and with the Chagas confirmatory assay.
1040086|NCT00718042|P1|Participant Flow|ABBOTT PRISM Chagas Specificity|All blood donor specimens tested by the investigational Chagas screening test in design validation phase.
1040087|NCT00718042|O1|Outcome|Reactivity in Chagas Endemic Population|Specimen from Chagas endemic area in South or Central America (524) under separate specimen collection protocol were tested with investigational ESA Chagas.
1040088|NCT00718042|O1|Outcome|ESA Chagas Non-US Serologically Positive|Specimen antibody positive for T cruzi antibody collected in South America (85) under separate specimen collection protocols.
1040089|NCT00718042|O1|Outcome|Sensitivity Chagas Parasitology Positive Specimens|Specimen collected in South or Central America under separate specimen collection protocols were tested with investigational with ESA Chagas.
1040090|NCT00718042|O1|Outcome|ESA Chagas Specificity|US blood donor specimen presumed antibody negative for T cruzi antibody were tested with investigational ESA Chagas.
1040091|NCT00718042|O1|Outcome|ESA Chagas US Donor Specimen Testing|A total of 58 PRISM Chagas repeatedly reactive US blood donor specimens tested with both ESA Chagas and RIPA.
1040092|NCT00718042|O1|Outcome|PRISM Chagas Reactivity Endemic Population|Specimen collected in Chagas endemic area in South/Central America (524) under separate specimen collection protocol were tested with investigational Chagas screening assay and with the Chagas Confirmatory assay.
1040093|NCT00718042|O1|Outcome|Sensitivity Chagas Parasitology Positive Specimens|Specimen collected in South/Central America under separate specimen collection protocols were tested with investigational Chagas screening assay.
1040094|NCT00718042|O1|Outcome|Reactivity T Cruzi Antibody Positive|Specimen positive for T cruzi antibody collected in South America (85) under separate specimen collection protocol and unidentified US blood donor specimens repeatedly reactive by T cruzi antibody licensed screening assay (202) were tested with investigational PRISM Chagas screening assay.
1040095|NCT00718042|O1|Outcome|ABBOTT PRISM Chagas Specificity|Specificity will be determined for the blood donor specimens tested with the investigational PRISM Chagas screening test.
1040096|NCT00718042|E1|Reported Event|Donor Follow-up Specimen Collection|Blood donors
1040097|NCT00717977|B1|Baseline|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
1040098|NCT00717977|P1|Participant Flow|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
1040099|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
1040100|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
1040101|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
1040102|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
1040103|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
1040104|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
1040105|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
1053923|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
1040238|NCT00717249|O2|Outcome|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
1040106|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
1040107|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
1040108|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
1040109|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
1040110|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
1040111|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
1040112|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
1040113|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
1040114|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
1040115|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
1040116|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
1040117|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
1040118|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
1040119|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
1040120|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
1040121|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
1040122|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
1040123|NCT00717977|O1|Outcome|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
1040124|NCT00717977|E1|Reported Event|All Non-Diabetic Subjects|Subjects were healthy adults, adolescents, and children who were clinic staff, friends, relatives of clinic staff, or relatives or acquaintances of an indiviual with type 1 diabetes.
1040125|NCT00717886|B1|Baseline|Upper Extremity Lymphatic Mapping for Breast Cancer Patients|Patients with documented axillary metastases (Stage II breast cancer) will undergo subdermal injection of technetium sulfur colloid (TSC) into the ipsilateral upper extremity approximately 3 hours before surgery.
1040126|NCT00717886|P1|Participant Flow|Upper Extremity Lymphatic Mapping for Breast Cancer Patients|Patients with documented axillary metastases (Stage II breast cancer) will undergo subdermal injection of technetium sulfur colloid (TSC) into the ipsilateral upper extremity approximately 3 hours before surgery.
1040127|NCT00717886|O1|Outcome|Upper Extremity Lymphatic Mapping for Breast Cancer Patients|Patients with documented axillary metastases (Stage II breast cancer) will undergo subdermal injection of technetium sulfur colloid (TSC) into the ipsilateral upper extremity approximately 3 hours before surgery.
1040128|NCT00717886|E1|Reported Event|Upper Extremity Lymphatic Mapping for Breast Cancer Patients|Patients with documented axillary metastases (Stage II breast cancer) will undergo subdermal injection of technetium sulfur colloid (TSC) into the ipsilateral upper extremity approximately 3 hours before surgery.
1040129|NCT00717873|B3|Baseline|Total|Total of all reporting groups
1040130|NCT00717873|B2|Baseline|CPT Arm|Airway clearance provided by manual CPT
1040131|NCT00717873|B1|Baseline|HFCWO Arm|Airway clearance provided by the Vest Airway Clearance System
1040132|NCT00717873|P2|Participant Flow|CPT Arm|Airway clearance provided by manual CPT
1040133|NCT00717873|P1|Participant Flow|HFCWO Arm|Airway clearance provided by the Vest Airway Clearance System
1040134|NCT00717873|O2|Outcome|CPT Arm|Airway clearance provided by manual CPT
1040135|NCT00717873|O1|Outcome|HFCWO Arm|Airway clearance provided by the Vest Airway Clearance System
1040136|NCT00717873|E2|Reported Event|CPT Arm|Airway clearance provided by manual CPT
1040137|NCT00717873|E1|Reported Event|HFCWO Arm|Airway clearance provided by the Vest Airway Clearance System
1040138|NCT00717860|B3|Baseline|Total|Total of all reporting groups
1040139|NCT00717860|B2|Baseline|Micafungin|Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
1040733|NCT00716092|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1040140|NCT00717860|B1|Baseline|Caspofungin|Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
1040141|NCT00717860|P2|Participant Flow|Micafungin|Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
1040142|NCT00717860|P1|Participant Flow|Caspofungin|Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
1040143|NCT00717860|O2|Outcome|Micafungin|Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
1040144|NCT00717860|O1|Outcome|Caspofungin|Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
1040145|NCT00717860|O2|Outcome|Micafungin|Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
1040146|NCT00717860|O1|Outcome|Caspofungin|Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
1040147|NCT00717860|O2|Outcome|Micafungin|Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
1040148|NCT00717860|O1|Outcome|Caspofungin|Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
1040149|NCT00717860|E2|Reported Event|Micafungin|Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
1040150|NCT00717860|E1|Reported Event|Caspofungin|Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
1040151|NCT00717756|B1|Baseline|Lenalidomide|lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle
1040152|NCT00717756|P1|Participant Flow|Lenalidomide|lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle
1040153|NCT00717756|O1|Outcome|Lenalidomide|lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle
1040154|NCT00717756|E1|Reported Event|Lenalidomide|lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle
1040155|NCT00717522|B1|Baseline|Pomalidomide|7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
1040156|NCT00717522|P1|Participant Flow|Pomalidomide|7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
1040157|NCT00717522|O1|Outcome|Pomalidomide|7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
1040158|NCT00717522|O1|Outcome|Pomalidomide|7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
1040159|NCT00717522|E1|Reported Event|Pomalidomide|7 mg pomalidomide taken orally once daily (QD) on days 1 through 21 of each 28-day cycle
1040160|NCT00717418|B5|Baseline|Total|Total of all reporting groups
1040161|NCT00717418|B4|Baseline|Missing Treatment Information|
1040162|NCT00717418|B3|Baseline|Combination Treatments|
1040163|NCT00717418|B2|Baseline|Artificial Tears Alone|
1040164|NCT00717418|B1|Baseline|Restasis® Alone|cyclosporine ophthalmic emulsion 0.05%
1040165|NCT00717418|P4|Participant Flow|Missing Treatment Information|
1040166|NCT00717418|P3|Participant Flow|Combination Treatments|
1040167|NCT00717418|P2|Participant Flow|Artificial Tears Alone|
1040168|NCT00717418|P1|Participant Flow|Restasis® Alone|cyclosporine ophthalmic emulsion 0.05%
1040169|NCT00717418|O1|Outcome|All Patients|
1040170|NCT00717418|O1|Outcome|All Patients|
1040171|NCT00717418|E1|Reported Event|All Patients|
1040172|NCT00717405|B1|Baseline|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
1040181|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
1040173|NCT00717405|P1|Participant Flow|Bevacizumab + Trastuzumab Chemotherapy|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 milligrams per kilogram (mg/kg) intravenous (IV) bevacizumab every 3 weeks (q3w) for 8 cycles, 4 cycles of 500 milligrams per squared-meter (mg/m^2) IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
1040174|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
1040175|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
1040176|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
1040177|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
1040178|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
1040179|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
1040180|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
1040233|NCT00717249|B3|Baseline|Total|Total of all reporting groups
1040182|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
1040183|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
1040184|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
1040185|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
1040186|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
1040187|NCT00717405|O1|Outcome|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
1040188|NCT00717405|E1|Reported Event|Bevacizumab + Trastuzumab|Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.
1040189|NCT00717314|B3|Baseline|Total|Total of all reporting groups
1040190|NCT00717314|B2|Baseline|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
1040234|NCT00717249|B2|Baseline|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
1040235|NCT00717249|B1|Baseline|Galyfilcon A w/ Silver|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
1053924|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
1040191|NCT00717314|B1|Baseline|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
1040192|NCT00717314|P2|Participant Flow|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
1040193|NCT00717314|P1|Participant Flow|Mycophenolate Mofetil (MMF), 50% Calcineurin Inhibitor (CNI)|Participants received MMF capsules, 1.5 to 2.0 grams (g), orally (PO), twice daily (BID) up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50 percent (%) through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
1040194|NCT00717314|O2|Outcome|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
1040195|NCT00717314|O1|Outcome|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
1040196|NCT00717314|O2|Outcome|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
1040197|NCT00717314|O1|Outcome|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
1040198|NCT00717314|O2|Outcome|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
1040199|NCT00717314|O1|Outcome|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
1040200|NCT00717314|O2|Outcome|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
1040201|NCT00717314|O1|Outcome|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
1040202|NCT00717314|O2|Outcome|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
1040236|NCT00717249|P2|Participant Flow|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
1040237|NCT00717249|P1|Participant Flow|Galyfilcon A w/ Silver|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
1040203|NCT00717314|O1|Outcome|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
1040204|NCT00717314|O2|Outcome|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
1040205|NCT00717314|O1|Outcome|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
1040206|NCT00717314|O2|Outcome|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
1040207|NCT00717314|O1|Outcome|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
1040208|NCT00717314|E2|Reported Event|MMF, 75% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
1040209|NCT00717314|E1|Reported Event|MMF, 50% CNI|Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
1040210|NCT00717288|B4|Baseline|Total|Total of all reporting groups
1040211|NCT00717288|B3|Baseline|80% Conversion Factor|Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily
1040212|NCT00717288|B2|Baseline|65% Conversion Factor|Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily
1040213|NCT00717288|B1|Baseline|50% Conversion Factor|Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily
1040214|NCT00717288|P3|Participant Flow|80% Conversion Factor|Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily
1040215|NCT00717288|P2|Participant Flow|65% Conversion Factor|Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily
1040216|NCT00717288|P1|Participant Flow|50% Conversion Factor|Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily
1040217|NCT00717288|O3|Outcome|80% Conversion Factor|Number of subjects that reverted back to an insulin drip
1040218|NCT00717288|O2|Outcome|65% Conversion Factor|Number of subjects that reverted back to an insulin drip
1040219|NCT00717288|O1|Outcome|50% Conversion Factor|Number of subjects that reverted back to an insulin drip
1040220|NCT00717288|O3|Outcome|80% Conversion Factor|Number of subjects with a BG value <65 mg/dl
1040221|NCT00717288|O2|Outcome|65% Conversion Factor|Number of subjects with a BG value <65 mg/dl
1040222|NCT00717288|O1|Outcome|50% Conversion Factor|Number of subjects with a BG value <65 mg/dl
1040223|NCT00717288|O3|Outcome|80% Conversion Factor|Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily
1040224|NCT00717288|O2|Outcome|65% Conversion Factor|Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily
1040225|NCT00717288|O1|Outcome|50% Conversion Factor|Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily
1040226|NCT00717288|E3|Reported Event|80% Conversion Factor|Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily
1040227|NCT00717288|E2|Reported Event|65% Conversion Factor|Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily
1040228|NCT00717288|E1|Reported Event|50% Conversion Factor|Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily
1040229|NCT00717275|B1|Baseline|Temozolomide|Temozolomide 75mg/m2 taken by mouth on days 1-21 out of a 28 day month.
1040230|NCT00717275|P1|Participant Flow|Temozolomide|Temozolomide 75mg/m2 taken by mouth on days 1-21 out of a 28 day month.
1040231|NCT00717275|O1|Outcome|Temozolomide|Temozolomide 75mg/m2 taken by mouth on days 1-21 out of a 28 day month.
1040232|NCT00717275|E1|Reported Event|Temozolomide|Temozolomide 75mg/m2 taken by mouth on days 1-21 out of a 28 day month.
1040239|NCT00717249|O1|Outcome|Galyfilcon A w/ Silver|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
1040240|NCT00717249|O2|Outcome|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
1040241|NCT00717249|O1|Outcome|Galyfilcon A w/ Silver|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
1040242|NCT00717249|O2|Outcome|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
1040243|NCT00717249|O1|Outcome|Galyfilcon A w/ Silver|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
1040244|NCT00717249|O2|Outcome|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
1040245|NCT00717249|O1|Outcome|Galyfilcon A w/ Silver|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
1040246|NCT00717249|E2|Reported Event|Galyfilcon A|Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
1040247|NCT00717249|E1|Reported Event|Galyfilcon A w/ Silver|Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
1040248|NCT00717236|B3|Baseline|Total|Total of all reporting groups
1040249|NCT00717236|B2|Baseline|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040250|NCT00717236|B1|Baseline|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040251|NCT00717236|P2|Participant Flow|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040252|NCT00717236|P1|Participant Flow|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040253|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
1040254|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
1040255|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
1040256|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
1040257|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
1040258|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
1040259|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
1040260|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
1040261|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
1040262|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
1040263|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
1040264|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
1040265|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
1040266|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
1040267|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
1040268|NCT00717236|O1|Outcome|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
1040377|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
1040379|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
1040269|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040270|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040271|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040272|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040273|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040274|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040275|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040276|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040277|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040278|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040279|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040280|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040281|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040282|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040283|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040284|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040285|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040286|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040287|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040288|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040289|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040290|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040291|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040292|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040293|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040294|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040295|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040296|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040297|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040298|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040299|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040300|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040301|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040302|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040303|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040304|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040305|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040306|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040307|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040308|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040309|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040310|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040311|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040312|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040313|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040314|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040315|NCT00717236|O2|Outcome|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040316|NCT00717236|O1|Outcome|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
1040317|NCT00717236|E3|Reported Event|Open Label Certolizumab Pegol (CZP)|Subjects entering the open label extension at Week 12 receive 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
1040318|NCT00717236|E2|Reported Event|Placebo|Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. From Week 12, 200 mg certolizumab pegol (CZP) given as 1 subcutaneous injection every other week for a minimum 16 additional weeks until CZP is commercially available.
1040319|NCT00717236|E1|Reported Event|Certolizumab Pegol (CZP)|400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. From Week 12, 200 mg CZP given every other week for a minimum 16 additional weeks until CZP is commercially available.
1040320|NCT00717197|B1|Baseline|Capecitabine|Capecitabine (1,000-1,250 mg/m2) was taken by mouth twice daily for 14 out of 21 consecutive days until disease progression or unacceptable toxicity.
1040321|NCT00717197|P1|Participant Flow|Capecitabine|Capecitabine (1,000-1,250 mg/m2) was taken by mouth twice daily for 14 out of 21 consecutive days until disease progression or unacceptable toxicity.
1040322|NCT00717197|O1|Outcome|Capecitabine|Capecitabine (1,000-1,250 mg/m2) was taken by mouth twice daily for 14 out of 21 consecutive days until disease progression or unacceptable toxicity.
1040323|NCT00717197|E1|Reported Event|Capecitabine|Capecitabine (1,000-1,250 mg/m2) was taken by mouth twice daily for 14 out of 21 consecutive days until disease progression or unacceptable toxicity.
1040324|NCT00717093|B3|Baseline|Total|Total of all reporting groups
1040325|NCT00717093|B2|Baseline|Placebo|Subjects will be up-titrated with a matching placebo during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
1040326|NCT00717093|B1|Baseline|Varenicline Tartrate|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
1040327|NCT00717093|P2|Participant Flow|Placebo|Subjects will be up-titrated with a matching placebo during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
1040328|NCT00717093|P1|Participant Flow|Varenicline Tartrate|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
1040329|NCT00717093|O2|Outcome|Placebo|Subjects will be up-titrated with a matching placebo during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
1040330|NCT00717093|O1|Outcome|Varenicline Tartrate|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
1040331|NCT00717093|O2|Outcome|Placebo|Subjects will be up-titrated with a matching placebo during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
1040332|NCT00717093|O1|Outcome|Varenicline Tartrate|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
1040333|NCT00717093|O2|Outcome|Placebo|Subjects will be up-titrated with a matching placebo during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
1040334|NCT00717093|O1|Outcome|Varenicline Tartrate|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
1040335|NCT00717093|O2|Outcome|Placebo|Subjects will be up-titrated with a matching placebo during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
1040378|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
1040336|NCT00717093|O1|Outcome|Varenicline Tartrate|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
1040337|NCT00717093|E2|Reported Event|Placebo|Subjects will be up-titrated with a matching placebo during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
1040338|NCT00717093|E1|Reported Event|Varenicline Tartrate|Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
1040339|NCT00717067|B6|Baseline|Total|Total of all reporting groups
1040340|NCT00717067|B5|Baseline|ESRD on Hemodialysis|Subjects with End Stage Renal Disease Requiring Regular Hemodialysis 3 Times a Week for at Least 6 Weeks Prior to Screening (Creatinine Clearance <30 mL/min)
1040341|NCT00717067|B4|Baseline|Severe Renal Impairment|Subjects with Severe Renal Impairment (Creatinine Clearance <30 mL/min)
1040342|NCT00717067|B3|Baseline|Moderate Renal Impairment|Subjects with Moderate Renal Impairment (Creatinine Clearance ≥30 and ≤50 mL/min)
1040343|NCT00717067|B2|Baseline|Mild Renal Impairment|Subjects with Mild Renal Impairment (Creatinine Clearance >50 and ≤80 mL/min)
1040344|NCT00717067|B1|Baseline|Healthy Subjects|Subjects with Normal Renal Function (Creatinine Clearance > 80mL/min)
1040345|NCT00717067|P5|Participant Flow|ESRD: Single Dose|(I) Maraviroc single dose one hour following completion of morning hemodialysis, followed at least 1 week later by (II) Maraviroc single dose three hours prior to start of hemodialysis.
1040346|NCT00717067|P4|Participant Flow|Severe Renal Impairment|Maraviroc 300 mg single dose.
1040347|NCT00717067|P3|Participant Flow|Moderate Renal Impairment|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
1040348|NCT00717067|P2|Participant Flow|Mild Renal Impairment|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
1040349|NCT00717067|P1|Participant Flow|Healthy Subjects|(I) Maraviroc single 300 mg dose, followed 4 days later by (II) Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
1040350|NCT00717067|O7|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
1040351|NCT00717067|O6|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
1040352|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
1040353|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
1040354|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
1040355|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
1040356|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
1040357|NCT00717067|O7|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
1040358|NCT00717067|O6|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
1040359|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
1040360|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
1040361|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
1040362|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
1040363|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
1040364|NCT00717067|O7|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
1040365|NCT00717067|O6|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
1040366|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
1040367|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
1040368|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
1040369|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
1040370|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
1040371|NCT00717067|O1|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis
1040372|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
1040373|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
1040374|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
1040375|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
1040376|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
1040380|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
1040381|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
1040382|NCT00717067|O7|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
1040383|NCT00717067|O6|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
1040384|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
1040385|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
1040386|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
1040387|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
1040388|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
1040389|NCT00717067|O7|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
1040390|NCT00717067|O6|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
1040391|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
1040392|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
1040393|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
1040394|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
1040395|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
1040396|NCT00717067|O4|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
1040397|NCT00717067|O3|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
1040398|NCT00717067|O2|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
1040399|NCT00717067|O1|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
1040400|NCT00717067|O6|Outcome|ESRD|(I) Maraviroc 300 mg single dose one hour following completion of morning hemodialysis, followed at least 1 week later by (II) Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
1040401|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
1040402|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
1040403|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
1040404|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
1040405|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
1040406|NCT00717067|O7|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
1040407|NCT00717067|O6|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
1040408|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
1040409|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
1040410|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
1040411|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
1040412|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
1040413|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
1040414|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
1040415|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
1040416|NCT00717067|O7|Outcome|ESRD: Single Dose; Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
1040417|NCT00717067|O6|Outcome|ESRD: Single Dose; After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
1040418|NCT00717067|O5|Outcome|Severe Renal Impairment: Single Dose|Maraviroc 300 mg single dose.
1040419|NCT00717067|O4|Outcome|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
1040420|NCT00717067|O3|Outcome|Moderate Renal Impairment: Multiple Dose|Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
1040421|NCT00717067|O2|Outcome|Mild Renal Impairment: Multiple Dose|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
1053925|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
1040597|NCT00716625|O2|Outcome|Non-elderly|Participants aged ˂65 years who received sunitinib malate according to Japanese package insert
1040422|NCT00717067|O1|Outcome|Healthy Subjects: Multiple Dose|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
1040423|NCT00717067|E7|Reported Event|ESRD: Dosing Before Dialysis|Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
1040424|NCT00717067|E6|Reported Event|ESRD: Dosing After Dialysis|Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
1040425|NCT00717067|E5|Reported Event|Severe Renal Impairment:|Maraviroc 300 mg single dose.
1040426|NCT00717067|E4|Reported Event|Healthy Subjects: Single Dose|Maraviroc 300 mg single dose.
1040427|NCT00717067|E3|Reported Event|Moderate Renal Impairment|Maraviroc 150 milligrams (mg) every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
1040428|NCT00717067|E2|Reported Event|Mild Renal Impairment|Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
1040429|NCT00717067|E1|Reported Event|Healthy Subjects|Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
1040430|NCT00717054|B3|Baseline|Total|Total of all reporting groups
1040431|NCT00717054|B2|Baseline|Aprepitant and Placebo Scopolamine Group|"Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Scopolamine: Placebo Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
1040432|NCT00717054|B1|Baseline|Aprepitant and Scopolamine Group|"Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
1040433|NCT00717054|P2|Participant Flow|Aprepitant and Placebo Scopolamine Group|"Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Scopolamine: Placebo Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
1040434|NCT00717054|P1|Participant Flow|Aprepitant and Scopolamine Group|"Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
1040435|NCT00717054|O2|Outcome|Aprepitant and Scopolamine Placebo Group|"Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
1040436|NCT00717054|O1|Outcome|Aprepitant and Scopolamine Group|"Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
1040437|NCT00717054|O2|Outcome|Aprepitant and Scopolamine Placebo Group|"Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
1040438|NCT00717054|O1|Outcome|Aprepitant and Scopolamine Group|"Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
1040439|NCT00717054|O2|Outcome|Aprepitant and Placebo Scopolamine Group|"Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Placebo Scopolamine: Placebo Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
1040440|NCT00717054|O1|Outcome|Aprepitant and Scopolamine Group|"Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
1040519|NCT00716820|B1|Baseline|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
1040441|NCT00717054|O2|Outcome|Aprepitant and Placebo Scopolamine Group|"Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Placebo Scopolamine: Placebo Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
1040442|NCT00717054|O1|Outcome|Aprepitant and Scopolamine Group|"Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
1040443|NCT00717054|E2|Reported Event|Aprepitant and Scopolamine Placebo Group|"Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
1040444|NCT00717054|E1|Reported Event|Aprepitant and Scopolamine Group|"Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.~Aprepitant: Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia~Scopolamine: Scopolamine transdermal applied to skin behind the ear one hour prior to surgery"
1040445|NCT00717041|B1|Baseline|Presenting to the ED|Patients who present to the ED
1040446|NCT00717041|P1|Participant Flow|Presenting to the ED|Patients who present to the ED
1040447|NCT00717041|O2|Outcome|Cognitively Impaired in the ED|Patients presenting to the ED who have cognitive impairment
1040448|NCT00717041|O1|Outcome|Depressed in the ED|Patients who present to the ED who test positive for depression
1040449|NCT00717041|O1|Outcome|Presenting to the ED|Patients who present to the ED
1040450|NCT00717041|O1|Outcome|Presenting to the ED|Patients who present to the ED
1040451|NCT00717041|O1|Outcome|Presenting to the ED|Patients who present to the ED
1040452|NCT00717041|E1|Reported Event|Presenting to the ED|Patients who present to the ED
1040453|NCT00716976|B3|Baseline|Total|Total of all reporting groups
1040454|NCT00716976|B2|Baseline|Observation Arm|No sodium thiosulfate treatment.
1040455|NCT00716976|B1|Baseline|STS Arm (Sodium Thiosulfate Treatment)|Sodium thiosulfate treatment.
1040456|NCT00716976|P2|Participant Flow|Observation Arm|No sodium thiosulfate treatment.
1040457|NCT00716976|P1|Participant Flow|STS Arm (Sodium Thiosulfate Treatment)|Sodium thiosulfate treatment.
1040458|NCT00716976|O2|Outcome|Observation Arm|No sodium thiosulfate treatment.
1040459|NCT00716976|O1|Outcome|STS Arm (Sodium Thiosulfate Treatment)|Sodium thiosulfate treatment.
1040460|NCT00716976|O2|Outcome|Observation Arm|No sodium thiosulfate treatment.
1040461|NCT00716976|O1|Outcome|STS Arm (Sodium Thiosulfate Treatment)|Sodium thiosulfate treatment.
1040462|NCT00716976|O2|Outcome|Observation Arm|No sodium thiosulfate treatment.
1040463|NCT00716976|O1|Outcome|STS Arm (Sodium Thiosulfate Treatment)|Sodium thiosulfate treatment.
1040464|NCT00716976|O2|Outcome|Observation Arm|No sodium thiosulfate treatment.
1040465|NCT00716976|O1|Outcome|STS Arm (Sodium Thiosulfate Treatment)|Sodium thiosulfate treatment.
1040466|NCT00716976|O2|Outcome|Observation Arm|No sodium thiosulfate treatment.
1040467|NCT00716976|O1|Outcome|STS Arm (Sodium Thiosulfate Treatment)|Sodium thiosulfate treatment.
1040468|NCT00716976|O2|Outcome|Observation Arm|No sodium thiosulfate treatment.
1040469|NCT00716976|O1|Outcome|STS Arm (Sodium Thiosulfate Treatment)|Sodium thiosulfate treatment.
1040470|NCT00716976|O2|Outcome|Observation Arm|No sodium thiosulfate treatment.
1040471|NCT00716976|O1|Outcome|STS Arm (Sodium Thiosulfate Treatment)|Sodium thiosulfate treatment.
1040472|NCT00716976|O2|Outcome|Observation Arm|No sodium thiosulfate treatment.
1040473|NCT00716976|O1|Outcome|STS Arm (Sodium Thiosulfate Treatment)|Sodium thiosulfate treatment.
1040474|NCT00716976|E2|Reported Event|Observation Arm|
1040475|NCT00716976|E1|Reported Event|STS Arm (Sodium Thiosulfate Treatment)|
1040476|NCT00716963|B1|Baseline|Screening/Baseline Participants|
1040477|NCT00716963|P6|Participant Flow|Placebo/Budesonide/Fluticasone|Subjects receive placebo after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Budesonide after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Fluticasone after early allergic response induced by allergen challenge.
1040478|NCT00716963|P5|Participant Flow|Placebo/Fluticasone/Budesonide|Subjects receive placebo after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Fluticasone after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Budesonide after early allergic response induced by allergen challenge.
1040479|NCT00716963|P4|Participant Flow|Budesonide/Placebo/Fluticasone|Subjects receive Budesonide after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive placebo after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Fluticasone after early allergic response induced by allergen challenge.
1040480|NCT00716963|P3|Participant Flow|Budesonide/Fluticasone/Placebo|Subjects receive Budesonide after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Fluticasone after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive placebo after early allergic response induced by allergen challenge.
1040596|NCT00716625|O3|Outcome|Unknown|Participants with unknown age who received sunitinib malate according to Japanese package insert
1053926|NCT00684307|O5|Outcome|VKA INR 2-3|
1040481|NCT00716963|P2|Participant Flow|Fluticasone/Placebo/Budesonide|Subjects receive Fluticasone after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive placebo after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Budesonide after early allergic response induced by allergen challenge.
1040482|NCT00716963|P1|Participant Flow|Fluticasone/Budesonide/Placebo|Subjects receive Fluticasone after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Budesonide after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive placebo after early allergic response induced by allergen challenge.
1040483|NCT00716963|O3|Outcome|Placebo|
1040484|NCT00716963|O2|Outcome|Budesonide 400mcg|
1040485|NCT00716963|O1|Outcome|Fluticasone Propionate (Flovent Diskus) 250 mcg|
1040486|NCT00716963|O3|Outcome|Placebo|
1040487|NCT00716963|O2|Outcome|Budesonide 400mcg|
1040488|NCT00716963|O1|Outcome|Fluticasone Propionate (Flovent Diskus) 250 mcg|
1040489|NCT00716963|E3|Reported Event|Placebo|
1040490|NCT00716963|E2|Reported Event|Budesonide 400mcg|
1040491|NCT00716963|E1|Reported Event|Fluticasone Propionate (Flovent Diskus) 250 mcg|
1040492|NCT00716859|B3|Baseline|Total|Total of all reporting groups
1040493|NCT00716859|B2|Baseline|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
1040494|NCT00716859|B1|Baseline|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
1040495|NCT00716859|P2|Participant Flow|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
1040496|NCT00716859|P1|Participant Flow|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
1040497|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
1040498|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
1040499|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
1040500|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
1040501|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
1040502|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
1040503|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
1040504|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
1040505|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
1040506|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
1040507|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
1040508|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
1040509|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
1040510|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
1040511|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
1040512|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
1040513|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
1040514|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
1040515|NCT00716859|O2|Outcome|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
1040516|NCT00716859|O1|Outcome|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
1040517|NCT00716859|E2|Reported Event|Latanoprost|Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.
1040518|NCT00716859|E1|Reported Event|Timolol|Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for participants younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .
1040729|NCT00716092|P2|Participant Flow|BI1356|Patients randomized to receive treatment with BI1356 5 mg
1040520|NCT00716820|P1|Participant Flow|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
1040521|NCT00716820|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
1040522|NCT00716820|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
1040523|NCT00716820|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
1040524|NCT00716820|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
1040525|NCT00716820|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
1040526|NCT00716820|O3|Outcome|Without Concomitant CYP3A4 Inhibitors|Participants without concomitant CYP3A4 inhibitors on sunitinib malate treatment according to Japanese package insert
1040527|NCT00716820|O2|Outcome|With Concomitant CYP3A4 Inhibitors (During Treatment)|Participants with concomitant CYP3A4 inhibitors during sunitinib malate treatment according to Japanese package insert
1040528|NCT00716820|O1|Outcome|With Concomitant CYP3A4 Inhibitors (Start of Treatment)|Participants with concomitant CYP3A4 inhibitors at start of sunitinib malate treatment according to Japanese package insert
1040529|NCT00716820|O3|Outcome|Unknown|Participants with no information on baseline renal impairment who received sunitinib malate according to Japanese package insert
1040530|NCT00716820|O2|Outcome|Without Renal Impairment|Participants without baseline renal impairment who received sunitinib malate according to Japanese package insert
1040531|NCT00716820|O1|Outcome|With Renal Impairment|Participants with baseline renal impairment who received sunitinib malate according to Japanese package insert
1040532|NCT00716820|O3|Outcome|Unknown|Participants with no information on baseline hepatic impairment who received sunitinib malate according to Japanese package insert
1040533|NCT00716820|O2|Outcome|Without Hepatic Impairment|Participants without baseline hepatic impairment who received sunitinib malate according to Japanese package insert
1040534|NCT00716820|O1|Outcome|With Hepatic Impairment|Participants with baseline hepatic impairment who received sunitinib malate according to Japanese package insert
1040535|NCT00716820|O3|Outcome|Unknown|Participants with unknown age who received sunitinib malate according to Japanese package insert
1040536|NCT00716820|O2|Outcome|Non-elderly|Participants aged ˂65 years who received sunitinib malate according to Japanese package insert
1040537|NCT00716820|O1|Outcome|Elderly|Participants aged ˃=65 years who received sunitinib malate according to Japanese package insert
1040538|NCT00716820|O3|Outcome|Unknown|Participants with unknown PDGFRα mutation status who received sunitinib malate according to Japanese package insert
1040539|NCT00716820|O2|Outcome|PDGFRα Without Mutation|Participants without PDGFRα mutation who received sunitinib malate according to Japanese package insert
1040540|NCT00716820|O1|Outcome|PDGFRα With Mutation|Participants with PDGFRα mutation who received sunitinib malate according to Japanese package insert
1040541|NCT00716820|O3|Outcome|Unknown|Participants with unknown c-kit mutation status who received sunitinib malate according to Japanese package insert
1040542|NCT00716820|O2|Outcome|c-Kit Without Mutation|Participants without c-kit mutation who received sunitinib malate according to Japanese package insert
1040543|NCT00716820|O1|Outcome|c-Kit With Mutation|Participants with c-kit mutation who received sunitinib malate according to Japanese package insert
1040544|NCT00716820|O3|Outcome|Unknown|Participants with unknown KIT expression status who received sunitinib malate according to Japanese package insert
1040545|NCT00716820|O2|Outcome|KIT Negative|Participants with negative KIT expression who received sunitinib malate according to Japanese package insert
1040546|NCT00716820|O1|Outcome|KIT Positive|Participants with positive KIT expression who received sunitinib malate according to Japanese package insert
1040547|NCT00716820|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
1040548|NCT00716820|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
1040549|NCT00716820|E1|Reported Event|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
1040550|NCT00716807|B5|Baseline|Total|Total of all reporting groups
1040551|NCT00716807|B4|Baseline|TMD Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
1040552|NCT00716807|B3|Baseline|TMD Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
1040553|NCT00716807|B2|Baseline|BMS Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: Burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
1040554|NCT00716807|B1|Baseline|BMS Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
1040555|NCT00716807|P4|Participant Flow|TMD Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
1040734|NCT00716092|O3|Outcome|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
1040556|NCT00716807|P3|Participant Flow|TMD Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
1040557|NCT00716807|P2|Participant Flow|BMS Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: Burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
1040558|NCT00716807|P1|Participant Flow|BMS Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
1040559|NCT00716807|O4|Outcome|TMD Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
1040560|NCT00716807|O3|Outcome|TMD Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
1040561|NCT00716807|O2|Outcome|BMS Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: Burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
1040562|NCT00716807|O1|Outcome|BMS Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
1040563|NCT00716807|E4|Reported Event|TMD Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
1040564|NCT00716807|E3|Reported Event|TMD Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
1040565|NCT00716807|E2|Reported Event|BMS Nalbuphine + Placebo|nalbuphine plus placebo : Patient group: Burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
1040566|NCT00716807|E1|Reported Event|BMS Nalbuphine + Naloxone|nalbuphine plus naloxone : Patient group: burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).
1040567|NCT00716742|B4|Baseline|Total|Total of all reporting groups
1040568|NCT00716742|B3|Baseline|Xalatan®|latanoprost 0.005%
1040569|NCT00716742|B2|Baseline|Travatan®|travoprost 0.004%
1040570|NCT00716742|B1|Baseline|Lumigan®|bimatoprost 0.03%
1040571|NCT00716742|P3|Participant Flow|Xalatan®|latanoprost 0.005%
1040572|NCT00716742|P2|Participant Flow|Travatan®|travoprost 0.004%
1040573|NCT00716742|P1|Participant Flow|Lumigan®|bimatoprost 0.03%
1040574|NCT00716742|O3|Outcome|Xalatan®|latanoprost 0.005%
1040575|NCT00716742|O2|Outcome|Travatan®|travoprost 0.004%
1040576|NCT00716742|O1|Outcome|Lumigan®|bimatoprost 0.03%
1040577|NCT00716742|E3|Reported Event|Xalatan®|latanoprost 0.005%
1040578|NCT00716742|E2|Reported Event|Travatan®|travoprost 0.004%
1040579|NCT00716742|E1|Reported Event|Lumigan®|bimatoprost 0.03%
1040580|NCT00716625|B1|Baseline|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
1040581|NCT00716625|P1|Participant Flow|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
1040582|NCT00716625|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
1040583|NCT00716625|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
1040584|NCT00716625|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
1040585|NCT00716625|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
1040586|NCT00716625|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
1040587|NCT00716625|O3|Outcome|Without Concomitant CYP3A4 Inhibitors|Participants without concomitant CYP3A4 inhibitors on sunitinib malate treatment according to Japanese package insert
1040588|NCT00716625|O2|Outcome|With Concomitant CYP3A4 Inhibitors (During Treatment)|Participants with concomitant CYP3A4 inhibitors during sunitinib malate treatment according to Japanese package insert
1040589|NCT00716625|O1|Outcome|With Concomitant CYP3A4 Inhibitors (Start of Treatment)|Participants with concomitant CYP3A4 inhibitors at start of sunitinib malate treatment according to Japanese package insert
1040590|NCT00716625|O3|Outcome|Unknown|Participants with no information on baseline renal impairment who received sunitinib malate according to Japanese package insert
1040591|NCT00716625|O2|Outcome|Without Renal Impairment|Participants without baseline renal impairment who received sunitinib malate according to Japanese package insert
1040592|NCT00716625|O1|Outcome|With Renal Impairment|Participants with baseline renal impairment who received sunitinib malate according to Japanese package insert
1040593|NCT00716625|O3|Outcome|Unknown|Participants with no information on baseline hepatic impairment who received sunitinib malate according to Japanese package insert
1040594|NCT00716625|O2|Outcome|Without Hepatic Impairment|Participants without baseline hepatic impairment who received sunitinib malate according to Japanese package insert
1040595|NCT00716625|O1|Outcome|With Hepatic Impairment|Participants with baseline hepatic impairment who received sunitinib malate according to Japanese package insert
1040598|NCT00716625|O1|Outcome|Elderly|Participants aged ˃=65 years who received sunitinib malate according to Japanese package insert
1040599|NCT00716625|O3|Outcome|Unknown|Participants with unknown age who received sunitinib malate according to Japanese package insert
1040600|NCT00716625|O2|Outcome|Adult|Participants aged ˃=15 years who received sunitinib malate according to Japanese package insert
1040601|NCT00716625|O1|Outcome|Pediatric|Participants aged ˂15 years who received sunitinib malate according to Japanese package insert
1040602|NCT00716625|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
1040603|NCT00716625|O1|Outcome|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
1040604|NCT00716625|E1|Reported Event|Sunitinib Malate|Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.
1040605|NCT00716482|B1|Baseline|Breast Lesion|B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
1040606|NCT00716482|P1|Participant Flow|Breast Lesion|B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
1040607|NCT00716482|O1|Outcome|Overall (All Masses)|Benign and malignant lesions
1040608|NCT00716482|O1|Outcome|Overall (All Masses)|614 benign and 144 malignant masses
1040609|NCT00716482|O3|Outcome|Not Homogeneous|"The Elastography image of the lesion is inhomogeneous and has a mottled or patchy appearance throughout."
1040610|NCT00716482|O2|Outcome|Reasonably Homogeneous|"The Elastography image of the lesion has a slightly patchy appearance. The image may consist of larger (2-5mm) sub-regions within the lesion boundary that are homogenous, or the color differences between adjacent areas within the lesion are small."
1040611|NCT00716482|O1|Outcome|Very Homogeneous|The Elastography image of the lesion has a smooth and consistent color appearance throughout, or very subtle color differences relating to small changes on the color scale are observed.
1040612|NCT00716482|O2|Outcome|Sensitivity|Number of cancers with positive test results/total #number of cancers B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
1040613|NCT00716482|O1|Outcome|Specificity|Number of benign lesions with negative test results/total number of benign lesions B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
1040614|NCT00716482|E1|Reported Event|Breast Lesion|B-mode ultrasound examination with currently marketed machine followed by ultrasound B-mode examination and ShearWave Elastography examination
1040615|NCT00716456|B4|Baseline|Total|Total of all reporting groups
1040616|NCT00716456|B3|Baseline|Cetuximab 500 mg/m2|Cetuximab 500 mg/m2 IV every two weeks
1040617|NCT00716456|B2|Baseline|Cetuximab 375 mg/m2|Cetuximab 375 mg/m2 IV every two weeks
1040618|NCT00716456|B1|Baseline|Cetuximab 250 mg/m2|Cetuximab 250 mg/m2 IV every two weeks
1040619|NCT00716456|P3|Participant Flow|Cetuximab 500 mg/m2|Cetuximab 500 mg/m2 IV every two weeks
1040620|NCT00716456|P2|Participant Flow|Cetuximab 375 mg/m2|Cetuximab 375 mg/m2 IV every two weeks
1040621|NCT00716456|P1|Participant Flow|Cetuximab 250 mg/m2|Cetuximab 250 mg/m2 IV every two weeks
1040622|NCT00716456|O3|Outcome|Cetuximab 500 mg/m2|Cetuximab 500 mg/m2 IV every two weeks
1040623|NCT00716456|O2|Outcome|Cetuximab 375 mg/m2|Cetuximab 375 mg/m2 IV every two weeks
1040624|NCT00716456|O1|Outcome|Cetuximab 250 mg/m2|Cetuximab 250 mg/m2 IV every two weeks
1040625|NCT00716456|E3|Reported Event|Cetuximab 500 mg/m2|Cetuximab 500 mg/m2 IV every two weeks
1040626|NCT00716456|E2|Reported Event|Cetuximab 375 mg/m2|Cetuximab 375 mg/m2 IV every two weeks
1040627|NCT00716456|E1|Reported Event|Cetuximab 250 mg/m2|Cetuximab 250 mg/m2 IV every two weeks
1040628|NCT00716443|B1|Baseline|Pliaglis® Cream and Compounded Topical Anesthetic Ointment|Apply Pliaglis® Cream on one side of the face and compounded topical anesthetic ointment on the other side of the face; this was a randomized, split face study where Pliaglis® Cream was used on one side of the face and compounded topical anesthetic ointment was used on the other side of the face prior to injection of Restylane® into the nasolabial folds.
1040629|NCT00716443|P1|Participant Flow|Pliaglis® Cream and Compounded Topical Anesthetic Ointment|Apply Pliaglis® Cream on one side of the face and compounded topical anesthetic ointment on the other side of the face; this was a randomized, split face study where Pliaglis® Cream was used on one side of the face and compounded topical anesthetic ointment was used on the other side of the face prior to injection of Restylane® into the nasolabial folds.
1040630|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
1040631|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
1040632|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
1040633|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
1040634|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
1040635|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
1040636|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
1040637|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
1040638|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
1040639|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
1040640|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
1040641|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
1040642|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
1040643|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
1053927|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
1040644|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
1040646|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
1040647|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
1040648|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
1040649|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
1040650|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
1040651|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
1040652|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
1040653|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
1040654|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
1040655|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
1040656|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
1040657|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
1040658|NCT00716443|O2|Outcome|Compounded Topical Anesthetic Ointment|compounded topical anesthetic ointment
1040659|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
1040660|NCT00716443|E1|Reported Event|Pliaglis® Cream and Compounded Topical Anesthetic Ointment|Apply Pliaglis® Cream on one side of the face and compounded topical anesthetic ointment on the other side of the face; this was a randomized, split face study where Pliaglis® Cream was used on one side of the face and compounded topical anesthetic ointment was used on the other side of the face prior to injection of Restylane® into the nasolabial folds.
1040661|NCT00716417|B11|Baseline|Total|Total of all reporting groups
1040662|NCT00716417|B10|Baseline|Cis100 + 5FU1000 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040663|NCT00716417|B9|Baseline|Cis100 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040664|NCT00716417|B8|Baseline|Cis75 + 5FU750 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040665|NCT00716417|B7|Baseline|Cis75 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040666|NCT00716417|B6|Baseline|Cis75 + 5FU750 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040667|NCT00716417|B5|Baseline|Pac175 + Cis75 + Afatinib50|Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040668|NCT00716417|B4|Baseline|Pac175 + Cis75 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040669|NCT00716417|B3|Baseline|Pac175 + Cis75 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040670|NCT00716417|B2|Baseline|Pac175 + Cis75 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040671|NCT00716417|B1|Baseline|Pac175 + Cis50 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 50mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040672|NCT00716417|P10|Participant Flow|Cis100 + 5FU1000 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040673|NCT00716417|P9|Participant Flow|Cis100 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040674|NCT00716417|P8|Participant Flow|Cis75 + 5FU750 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040675|NCT00716417|P7|Participant Flow|Cis75 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040676|NCT00716417|P6|Participant Flow|Cis75 + 5FU750 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040677|NCT00716417|P5|Participant Flow|Pac175 + Cis75 + Afatinib50|Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040730|NCT00716092|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
1040731|NCT00716092|O3|Outcome|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
1040736|NCT00716092|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1084268|NCT00605072|B4|Baseline|Total|Total of all reporting groups
1040678|NCT00716417|P4|Participant Flow|Pac175 + Cis75 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040679|NCT00716417|P3|Participant Flow|Pac175 + Cis75 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040680|NCT00716417|P2|Participant Flow|Pac175 + Cis75 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040681|NCT00716417|P1|Participant Flow|Pac175 + Cis50 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 50mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040682|NCT00716417|O10|Outcome|Cis100 + 5FU1000 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040683|NCT00716417|O9|Outcome|Cis100 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040684|NCT00716417|O8|Outcome|Cis75 + 5FU750 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040685|NCT00716417|O7|Outcome|Cis75 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040686|NCT00716417|O6|Outcome|Cis75 + 5FU750 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040687|NCT00716417|O5|Outcome|Pac175 + Cis75 + Afatinib50|Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040688|NCT00716417|O4|Outcome|Pac175 + Cis75 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040689|NCT00716417|O3|Outcome|Pac175 + Cis75 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040690|NCT00716417|O2|Outcome|Pac175 + Cis75 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040691|NCT00716417|O1|Outcome|Pac175 + Cis50 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 50mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040692|NCT00716417|O10|Outcome|Cis100 + 5FU1000 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040693|NCT00716417|O9|Outcome|Cis100 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040694|NCT00716417|O8|Outcome|Cis75 + 5FU750 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040695|NCT00716417|O7|Outcome|Cis75 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040696|NCT00716417|O6|Outcome|Cis75 + 5FU750 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040697|NCT00716417|O5|Outcome|Pac175 + Cis75 + Afatinib50|Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040698|NCT00716417|O4|Outcome|Pac175 + Cis75 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040699|NCT00716417|O3|Outcome|Pac175 + Cis75 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040700|NCT00716417|O2|Outcome|Pac175 + Cis75 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040701|NCT00716417|O1|Outcome|Pac175 + Cis50 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 50mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040702|NCT00716417|O2|Outcome|5FU + Cis + Afatinib (Regimen B)|Patients received continous daily dosing with Afatinib film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil and Cisplatin on day 1 of each cycle in 5 dose levels as outlined in first primary endpoint.
1040703|NCT00716417|O1|Outcome|Pac + Cis + Afatinib (Regimen A)|Patients received continous daily dosing with Afatinib film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel and Cisplatin on day 1 of each cycle in 5 dose levels as outlined in first primary endpoint.
1040704|NCT00716417|O10|Outcome|Cis100 + 5FU1000 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040705|NCT00716417|O9|Outcome|Cis100 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040706|NCT00716417|O8|Outcome|Cis75 + 5FU750 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040707|NCT00716417|O7|Outcome|Cis75 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040708|NCT00716417|O6|Outcome|Cis75 + 5FU750 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040709|NCT00716417|O5|Outcome|Pac175 + Cis75 + Afatinib50|Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040710|NCT00716417|O4|Outcome|Pac175 + Cis75 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040711|NCT00716417|O3|Outcome|Pac175 + Cis75 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040712|NCT00716417|O2|Outcome|Pac175 + Cis75 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040713|NCT00716417|O1|Outcome|Pac175 + Cis50 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 50mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040714|NCT00716417|E10|Reported Event|Cis100 + 5FU1000 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 1000mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040715|NCT00716417|E9|Reported Event|Cis100 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 100mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040716|NCT00716417|E8|Reported Event|Cis75 + 5FU750 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040717|NCT00716417|E7|Reported Event|Cis75 + 5FU750 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040718|NCT00716417|E6|Reported Event|Cis75 + 5FU750 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of 5-Fluorouracil 750mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040719|NCT00716417|E5|Reported Event|Pac175 + Cis75 + Afatinib50|Patients received continous daily dosing with Afatinib 50mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040720|NCT00716417|E4|Reported Event|Pac175 + Cis75 + Afatinib40|Patients received continous daily dosing with Afatinib 40mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040721|NCT00716417|E3|Reported Event|Pac175 + Cis75 + Afatinib30|Patients received continous daily dosing with Afatinib 30mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040722|NCT00716417|E2|Reported Event|Pac175 + Cis75 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 75mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040723|NCT00716417|E1|Reported Event|Pac175 + Cis50 + Afatinib20|Patients received continous daily dosing with Afatinib 20mg film-coated tablets over 21 day treatment cycles and infusions of Paclitaxel 175mg/m^2 and Cisplatin 50mg/m^2 on day 1 of each cycle. Treatment until disease progression or toxicity.
1040724|NCT00716092|B4|Baseline|Total|Total of all reporting groups
1040725|NCT00716092|B3|Baseline|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
1040726|NCT00716092|B2|Baseline|BI1356|Patients randomized to receive treatment with BI1356 5 mg
1040727|NCT00716092|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
1040728|NCT00716092|P3|Participant Flow|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
1040737|NCT00716092|O3|Outcome|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
1040738|NCT00716092|O2|Outcome|BI1356|Patients randomized to receive treatment with BI1356 5 mg
1040739|NCT00716092|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1040740|NCT00716092|O3|Outcome|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
1040741|NCT00716092|O2|Outcome|BI1356|Patients randomized to receive treatment with BI1356 5 mg
1040742|NCT00716092|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1040743|NCT00716092|O3|Outcome|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
1040744|NCT00716092|O2|Outcome|BI1356|Patients randomized to receive treatment with BI1356 5 mg
1040745|NCT00716092|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1040746|NCT00716092|O3|Outcome|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
1040747|NCT00716092|O2|Outcome|BI1356|Patients randomized to receive treatment with BI1356 5 mg
1040748|NCT00716092|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1040749|NCT00716092|O3|Outcome|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
1040750|NCT00716092|O2|Outcome|BI1356|Patients randomized to receive treatment with BI1356 5 mg
1040751|NCT00716092|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1040752|NCT00716092|O3|Outcome|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
1040753|NCT00716092|O2|Outcome|BI1356|Patients randomized to receive treatment with BI1356 5 mg
1040754|NCT00716092|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1040755|NCT00716092|E3|Reported Event|Sitagliptin|Patients randomized to receive treatment with Sitagliptin 100 mg
1040756|NCT00716092|E2|Reported Event|BI1356|Patients randomized to receive treatment with BI1356 5 mg
1040757|NCT00716092|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
1040758|NCT00716079|B3|Baseline|Total|Total of all reporting groups
1040759|NCT00716079|B2|Baseline|Guideline-Recommended Blood-Pressure Lowering|"Patients will receive management of BP that is based on a standard guideline, as published by the American Heart Association (AHA). The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
1040760|NCT00716079|B1|Baseline|Intensive Blood-Pressure Lowering|"Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
1040761|NCT00716079|P2|Participant Flow|Guideline-Recommended Blood-Pressure Lowering|"Patients will receive management of BP that is based on a standard guideline, as published by the American Heart Association (AHA). The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
1040762|NCT00716079|P1|Participant Flow|Intensive Blood-Pressure Lowering|"Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
1040763|NCT00716079|O2|Outcome|Guideline-Recommended Blood-Pressure Lowering|"Patients will receive management of BP that is based on a standard guideline, as published by the American Heart Association (AHA). The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
1040764|NCT00716079|O1|Outcome|Intensive Blood-Pressure Lowering|"Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
1040765|NCT00716079|O2|Outcome|Guideline-Recommended Blood-Pressure Lowering|"Patients will receive management of BP that is based on a standard guideline, as published by the American Heart Association (AHA). The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
1040830|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040831|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
1040766|NCT00716079|O1|Outcome|Intensive Blood-Pressure Lowering|"Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
1040767|NCT00716079|E2|Reported Event|Guideline-Recommended Blood-Pressure Lowering|"Patients will receive management of BP that is based on a standard guideline, as published by the American Heart Association (AHA). The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
1040768|NCT00716079|E1|Reported Event|Intensive Blood-Pressure Lowering|"Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour.~Blood pressure management policies : The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
1040769|NCT00715962|B3|Baseline|Total|Total of all reporting groups
1040770|NCT00715962|B2|Baseline|Control Group|"The control group will receive twice daily friendly visits. They will complete a diary but of visitors to their room.~Friendly visits: The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital."
1040771|NCT00715962|B1|Baseline|Mobility Group|"Participants will receive assistance to walk twice daily, plus encouragement to be more active throughout hospital stay. Participants will keep a diary of out of bed activity and will be encouraged to set goals for additional out of bed activity daily.~Behavioral encouragement of out of bed activity: Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors.~Walking Intervention: Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only"
1040772|NCT00715962|P2|Participant Flow|Control Group|"The control group will receive twice daily friendly visits. They will complete a diary but of visitors to their room.~Friendly visits: The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital."
1040773|NCT00715962|P1|Participant Flow|Mobility Group|"Participants will receive assistance to walk twice daily, plus encouragement to be more active throughout hospital stay. Participants will keep a diary of out of bed activity and will be encouraged to set goals for additional out of bed activity daily.~Behavioral encouragement of out of bed activity: Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors.~Walking Intervention: Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only"
1040774|NCT00715962|O2|Outcome|Control Group|"The control group will receive twice daily friendly visits. They will complete a diary but of visitors to their room.~Friendly visits: The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital."
1040775|NCT00715962|O1|Outcome|Mobility Group|"Participants will receive assistance to walk twice daily, plus encouragement to be more active throughout hospital stay. Participants will keep a diary of out of bed activity and will be encouraged to set goals for additional out of bed activity daily.~Behavioral encouragement of out of bed activity: Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors.~Walking Intervention: Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only"
1040776|NCT00715962|O2|Outcome|Control Group|"The control group will receive twice daily friendly visits. They will complete a diary but of visitors to their room.~Friendly visits: The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital."
1040777|NCT00715962|O1|Outcome|Mobility Group|"Participants will receive assistance to walk twice daily, plus encouragement to be more active throughout hospital stay. Participants will keep a diary of out of bed activity and will be encouraged to set goals for additional out of bed activity daily.~Behavioral encouragement of out of bed activity: Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors.~Walking Intervention: Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only"
1040778|NCT00715962|O2|Outcome|Control Group|"The control group will receive twice daily friendly visits. They will complete a diary but of visitors to their room.~Friendly visits: The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital."
1040803|NCT00715910|O3|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to <31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
1040779|NCT00715962|O1|Outcome|Mobility Group|"Participants will receive assistance to walk twice daily, plus a behavioral intervention that encouragement to be more active throughout hospital stay. Participants will keep a diary of out of bed activity and will be encouraged to set goals for additional out of bed activity daily.~Behavioral encouragement of out of bed activity: Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors.~Walking Intervention: Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only"
1040780|NCT00715962|E2|Reported Event|Control Group|"The control group will receive twice daily friendly visits. They will complete a diary but of visitors to their room.~Friendly visits: The control group will receive twice daily friendly visits and will be asked to complete a diary each day of the people who visit them in the hospital."
1040781|NCT00715962|E1|Reported Event|Mobility Group|"Participants will receive assistance to walk twice daily, plus encouragement to be more active throughout hospital stay. Participants will keep a diary of out of bed activity and will be encouraged to set goals for additional out of bed activity daily.~Behavioral encouragement of out of bed activity: Using social cognitive theory, participants in the walking program group will be encouraged to complete a brief diary about out of bed activities like sitting up for meals of walks to the bathroom. They will be provided with information regarding the importance of being out of bed a praise for any attempts. They will be asked to set out of bed time activity goals daily. The control group will have a diary to track visitors.~Walking Intervention: Participants in the walking program will be assisted to walk twice a day by trained staff. Those in the control group will be visited twice a day for friendly visits only"
1040782|NCT00715949|B1|Baseline|Admitted Pediatric With MTBI|admitted pediatric patients with minor traumatic brain injury
1040783|NCT00715949|P1|Participant Flow|Admitted Pediatric With MTBI|admitted pediatric patients with minor traumatic brain injury participating in computerized neurocognitive testing
1040784|NCT00715949|O1|Outcome|Admitted Pediatric With MTBI|admitted pediatric patients with minor traumatic brain injury
1040785|NCT00715949|E1|Reported Event|Admitted Pediatric With MTBI|admitted pediatric patients with minor traumatic brain injury
1040786|NCT00715910|B5|Baseline|Total|Total of all reporting groups
1040787|NCT00715910|B4|Baseline|Nimenrix naïve Group|Naïve control group of subjects 15 to < 31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
1040788|NCT00715910|B3|Baseline|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040789|NCT00715910|B2|Baseline|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
1040790|NCT00715910|B1|Baseline|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040791|NCT00715910|P6|Participant Flow|Nimenrix Naïve Group|Naïve control group of subjects 15 to < 31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
1040792|NCT00715910|P5|Participant Flow|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
1040793|NCT00715910|P4|Participant Flow|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
1040794|NCT00715910|P3|Participant Flow|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040795|NCT00715910|P2|Participant Flow|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
1040796|NCT00715910|P1|Participant Flow|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040797|NCT00715910|O3|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to < 31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
1040798|NCT00715910|O2|Outcome|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
1040799|NCT00715910|O1|Outcome|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
1040800|NCT00715910|O3|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to < 31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
1040801|NCT00715910|O2|Outcome|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
1040802|NCT00715910|O1|Outcome|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
1053928|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
1040804|NCT00715910|O2|Outcome|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
1040805|NCT00715910|O1|Outcome|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
1040806|NCT00715910|O3|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to <31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
1040807|NCT00715910|O2|Outcome|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
1040808|NCT00715910|O1|Outcome|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
1040809|NCT00715910|O3|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to <31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
1040810|NCT00715910|O2|Outcome|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
1040811|NCT00715910|O1|Outcome|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
1040812|NCT00715910|O3|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to <31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
1040813|NCT00715910|O2|Outcome|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
1040814|NCT00715910|O1|Outcome|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
1040815|NCT00715910|O3|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to <31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
1040816|NCT00715910|O2|Outcome|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
1040817|NCT00715910|O1|Outcome|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
1040818|NCT00715910|O3|Outcome|Nimenrix Naïve Group|Naïve control group of subjects 15 to <31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5
1040819|NCT00715910|O2|Outcome|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
1040820|NCT00715910|O1|Outcome|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
1040821|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040822|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
1040823|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040824|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040825|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
1040826|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040827|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040828|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
1040829|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040871|NCT00715884|B1|Baseline|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
1040832|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040833|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040834|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
1040835|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040836|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040837|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
1040838|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040839|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040840|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
1040841|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040842|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040843|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
1040844|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040845|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040846|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
1040847|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040848|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040849|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
1040850|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040851|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040852|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
1040853|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040854|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040855|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
1040856|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040857|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040858|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
1040859|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040860|NCT00715910|O3|Outcome|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040861|NCT00715910|O2|Outcome|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
1040862|NCT00715910|O1|Outcome|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040863|NCT00715910|E6|Reported Event|Nimenrix Naïve Group|Naïve control group of subjects 15 to <31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
1040864|NCT00715910|E5|Reported Event|Menactra Booster Group|Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and received 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
1040865|NCT00715910|E4|Reported Event|Nimenrix Pooled Group|Pooled group of subjects 10-25 years of age from Nimenrix 1 Group and Nimenrix 2 Group in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and received a booster dose administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5.
1040866|NCT00715910|E3|Reported Event|Nimenrix 2 Group|Subjects 10<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040867|NCT00715910|E2|Reported Event|Menactra Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination
1040868|NCT00715910|E1|Reported Event|Nimenrix 1 Group|Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination
1040869|NCT00715884|B3|Baseline|Total|Total of all reporting groups
1040870|NCT00715884|B2|Baseline|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
1040872|NCT00715884|P2|Participant Flow|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
1040873|NCT00715884|P1|Participant Flow|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
1040874|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
1040875|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
1040876|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
1040877|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
1040878|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
1040879|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
1040880|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
1040881|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
1040882|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
1040883|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
1040884|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
1040885|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
1040886|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
1040887|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
1040888|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
1040889|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
1040890|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
1040891|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
1040892|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
1040893|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
1040894|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
1040895|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
1040896|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
1040897|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
1040898|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
1040899|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
1040900|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
1040901|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
1040902|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
1040903|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
1040904|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
1040905|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
1040906|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
1040907|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
1040908|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
1040909|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
1040910|NCT00715884|O2|Outcome|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
1040911|NCT00715884|O1|Outcome|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
1040912|NCT00715884|E2|Reported Event|CYPHER®|CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
1040913|NCT00715884|E1|Reported Event|ELITE™|CYPHER® ELITE™ Sirolimus-Eluting Stent System.
1040914|NCT00715754|B1|Baseline|Infants|
1040915|NCT00715754|P1|Participant Flow|All Infants|One group comprised all infants evaluated.
1040916|NCT00715754|O1|Outcome|Newborn Infants|Newborn Infants
1040917|NCT00715754|O1|Outcome|Newborn Infants|Newborn Infants
1040918|NCT00715754|O1|Outcome|Newborn Infants|Newborn Infants
1040919|NCT00715754|E1|Reported Event|All Infants|One group comprised all infants evaluated.
1040920|NCT00715741|B5|Baseline|Total|Total of all reporting groups
1040921|NCT00715741|B4|Baseline|Fi02 0.9 Without PEEP|90% oxygen without PEEP
1040922|NCT00715741|B3|Baseline|Fi02 0.9 With PEEP|90% oxygen plus PEEP
1040923|NCT00715741|B2|Baseline|Fi02 0.3 Without PEEP|30% oxygen without PEEP
1040924|NCT00715741|B1|Baseline|Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP|30% oxygen with positive end expiratory pressure (PEEP)
1040925|NCT00715741|P4|Participant Flow|Fi02 0.9 Without PEEP|90% oxygen without PEEP
1040926|NCT00715741|P3|Participant Flow|Fi02 0.9 With PEEP|90% oxygen plus PEEP
1040927|NCT00715741|P2|Participant Flow|Fi02 0.3 Without PEEP|30% oxygen without PEEP
1040928|NCT00715741|P1|Participant Flow|Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP|30% oxygen with positive end expiratory pressure (PEEP)
1040929|NCT00715741|O4|Outcome|Fi02 0.9 Without PEEP|90% oxygen without PEEP
1040930|NCT00715741|O3|Outcome|Fi02 0.9 With PEEP|90% oxygen plus PEEP
1040931|NCT00715741|O2|Outcome|Fi02 0.3 Without PEEP|30% oxygen without PEEP
1040932|NCT00715741|O1|Outcome|Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP|30% oxygen with positive end expiratory pressure (PEEP)
1040933|NCT00715741|O4|Outcome|Fi02 0.9 Without PEEP|90% oxygen without PEEP
1040934|NCT00715741|O3|Outcome|Fi02 0.9 With PEEP|90% oxygen plus PEEP
1040935|NCT00715741|O2|Outcome|Fi02 0.3 Without PEEP|30% oxygen without PEEP
1040936|NCT00715741|O1|Outcome|Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP|30% oxygen with positive end expiratory pressure (PEEP)
1040937|NCT00715741|O4|Outcome|Fi02 0.9 Without PEEP|90% oxygen without PEEP
1040938|NCT00715741|O3|Outcome|Fi02 0.9 With PEEP|90% oxygen plus PEEP
1040939|NCT00715741|O2|Outcome|Fi02 0.3 Without PEEP|30% oxygen without PEEP
1041050|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
1041052|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
1040940|NCT00715741|O1|Outcome|Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP|30% oxygen with positive end expiratory pressure (PEEP)
1040941|NCT00715741|O4|Outcome|Fi02 0.9 Without PEEP|90% oxygen without PEEP
1040942|NCT00715741|O3|Outcome|Fi02 0.9 With PEEP|90% oxygen plus PEEP
1040943|NCT00715741|O2|Outcome|Fi02 0.3 Without PEEP|30% oxygen without PEEP
1040944|NCT00715741|O1|Outcome|Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP|30% oxygen with positive end expiratory pressure (PEEP)
1040945|NCT00715741|E4|Reported Event|Fi02 0.9 Without PEEP|90% oxygen without PEEP
1040946|NCT00715741|E3|Reported Event|Fi02 0.9 With PEEP|90% oxygen plus PEEP
1040947|NCT00715741|E2|Reported Event|Fi02 0.3 Without PEEP|30% oxygen without PEEP
1040948|NCT00715741|E1|Reported Event|Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP|30% oxygen with positive end expiratory pressure (PEEP)
1040949|NCT00715676|B4|Baseline|Total|Total of all reporting groups
1040950|NCT00715676|B3|Baseline|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
1040951|NCT00715676|B2|Baseline|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
1040952|NCT00715676|B1|Baseline|Placebo|Placebo soft gel capsules, oral, once daily
1040953|NCT00715676|P3|Participant Flow|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
1040954|NCT00715676|P2|Participant Flow|220 ng of Vitamin D Analog (DP001)|220 ng DP001 soft gel capsules, oral, once daily DP001 is also known as 2-methylene-19-nor-(20S)-1alpha, 25-dihydroxyvitamin D3.
1040955|NCT00715676|P1|Participant Flow|Placebo|Placebo soft gel capsules, oral, once daily
1040956|NCT00715676|O3|Outcome|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
1040957|NCT00715676|O2|Outcome|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
1040958|NCT00715676|O1|Outcome|Placebo|Placebo soft gel capsules, oral, once daily
1040959|NCT00715676|O3|Outcome|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
1040960|NCT00715676|O2|Outcome|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
1040961|NCT00715676|O1|Outcome|Placebo|Placebo soft gel capsules, oral, once daily
1040962|NCT00715676|O3|Outcome|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
1040963|NCT00715676|O2|Outcome|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
1040964|NCT00715676|O1|Outcome|Placebo|Placebo soft gel capsules, oral, once daily
1040965|NCT00715676|O3|Outcome|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
1040966|NCT00715676|O2|Outcome|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
1040967|NCT00715676|O1|Outcome|Placebo|Placebo soft gel capsules, oral, once daily
1040968|NCT00715676|O3|Outcome|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
1040969|NCT00715676|O2|Outcome|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
1040970|NCT00715676|O1|Outcome|Placebo|Placebo soft gel capsules, oral, once daily
1040971|NCT00715676|O3|Outcome|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
1040972|NCT00715676|O2|Outcome|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
1040973|NCT00715676|O1|Outcome|Placebo|Placebo soft gel capsules, oral, once daily
1040974|NCT00715676|O3|Outcome|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
1040975|NCT00715676|O2|Outcome|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
1040976|NCT00715676|O1|Outcome|Placebo|Placebo soft gel capsules, oral, once daily
1040977|NCT00715676|E3|Reported Event|440 ng DP001|440 ng DP001 soft gel capsules, oral, once daily
1040978|NCT00715676|E2|Reported Event|220 ng DP001|220 ng DP001 soft gel capsules, oral, once daily
1040979|NCT00715676|E1|Reported Event|Placebo|Placebo soft gel capsules, oral, once daily
1040980|NCT00715650|B3|Baseline|Total|Total of all reporting groups
1040981|NCT00715650|B2|Baseline|VA Orientation|Four sessions of VA orientation that taught veterans about the VA health care system generally and about the specific general medical and mental health services available to veterans
1040982|NCT00715650|B1|Baseline|Benefits Counseling|Four 50-minutes sessions of individual counseling using motivational interviewing to increase veterans' desire to engage in work and related activities
1040983|NCT00715650|P2|Participant Flow|VA Orientation|Four sessions of VA orientation that taught veterans about the VA health care system generally and about the specific general medical and mental health services available to veterans
1040984|NCT00715650|P1|Participant Flow|Benefits Counseling|Four 50-minutes sessions of individual counseling using motivational interviewing to increase veterans' desire to engage in work and related activities
1040985|NCT00715650|O2|Outcome|VA Orientation|Four sessions of VA orientation that taught veterans about the VA health care system generally and about the specific general medical and mental health services available to veterans
1040986|NCT00715650|O1|Outcome|Benefits Counseling|Four 50-minutes sessions of individual counseling using motivational interviewing to increase veterans' desire to engage in work and related activities
1040987|NCT00715650|O2|Outcome|VA Orientation|Four sessions of VA orientation that taught veterans about the VA health care system generally and about the specific general medical and mental health services available to veterans
1040988|NCT00715650|O1|Outcome|Benefits Counseling|Four 50-minutes sessions of individual counseling using motivational interviewing to increase veterans' desire to engage in work and related activities
1040989|NCT00715650|O2|Outcome|VA Orientation|Four sessions of VA orientation that taught veterans about the VA health care system generally and about the specific general medical and mental health services available to veterans
1040990|NCT00715650|O1|Outcome|Benefits Counseling|Four 50-minutes sessions of individual counseling using motivational interviewing to increase veterans' desire to engage in work and related activities
1040991|NCT00715650|O2|Outcome|VA Orientation|Four sessions of VA orientation that taught veterans about the VA health care system generally and about the specific general medical and mental health services available to veterans
1040992|NCT00715650|O1|Outcome|Benefits Counseling|Four 50-minutes sessions of individual counseling using motivational interviewing to increase veterans' desire to engage in work and related activities
1041051|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
1040993|NCT00715650|E2|Reported Event|VA Orientation|Four sessions of VA orientation that taught veterans about the VA health care system generally and about the specific general medical and mental health services available to veterans
1040994|NCT00715650|E1|Reported Event|Benefits Counseling|Four 50-minutes sessions of individual counseling using motivational interviewing to increase veterans' desire to engage in work and related activities
1040995|NCT00715624|B3|Baseline|Total|Total of all reporting groups
1040996|NCT00715624|B2|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
1040997|NCT00715624|B1|Baseline|Placebo|2-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
1040998|NCT00715624|P2|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
1040999|NCT00715624|P1|Participant Flow|Placebo|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
1041000|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1041001|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1041002|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1041003|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1041004|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1041005|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1041006|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1041007|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1041008|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1041009|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1041010|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1041011|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1041012|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1041013|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1041014|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1041015|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1041016|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1041017|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1041018|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1041019|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1041020|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1041021|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1041022|NCT00715624|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1041023|NCT00715624|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1041024|NCT00715624|E2|Reported Event|Lixisenatide|2-step initiation regimen of lixisenatide.
1041025|NCT00715624|E1|Reported Event|Placebo|2-step initiation regimen of volume matching placebo.
1041026|NCT00715559|B1|Baseline|Cysteamine Bitartrate|Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
1041027|NCT00715559|P1|Participant Flow|Cysteamine Bitartrate|Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
1041028|NCT00715559|O1|Outcome|Cysteamine Bitartrate|Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
1041029|NCT00715559|O1|Outcome|Cysteamine Bitartrate|Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
1041030|NCT00715559|O1|Outcome|Cysteamine Bitartrate|Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
1041031|NCT00715559|O1|Outcome|Cysteamine Bitartrate|Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
1041032|NCT00715559|E1|Reported Event|Cysteamine Bitartrate|Study participants received cysteamine bitartrate by mouth up to 300 mg three times daily
1041033|NCT00715403|B8|Baseline|Total|Total of all reporting groups
1041034|NCT00715403|B7|Baseline|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
1041035|NCT00715403|B6|Baseline|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
1041036|NCT00715403|B5|Baseline|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
1041037|NCT00715403|B4|Baseline|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
1041038|NCT00715403|B3|Baseline|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
1041039|NCT00715403|B2|Baseline|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
1041040|NCT00715403|B1|Baseline|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
1041041|NCT00715403|P7|Participant Flow|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
1041042|NCT00715403|P6|Participant Flow|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
1041043|NCT00715403|P5|Participant Flow|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
1041044|NCT00715403|P4|Participant Flow|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
1041045|NCT00715403|P3|Participant Flow|100mg BID|Patients were treated with 100 mg Nintedanib twice daily (BID).
1041046|NCT00715403|P2|Participant Flow|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
1041047|NCT00715403|P1|Participant Flow|50mg QD|Patients were treated with 50 mg Nintedanib once daily (QD) in the morning.
1041048|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
1041049|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
1041053|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
1041054|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
1041055|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
1041056|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
1041057|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
1041058|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
1041059|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
1041060|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
1041061|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
1041062|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
1041063|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
1041064|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
1041065|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
1041066|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
1041067|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
1041068|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
1041069|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
1041070|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
1041071|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
1041072|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
1041073|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
1041074|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
1041075|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
1041076|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
1041077|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
1041078|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
1041079|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
1041080|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
1041081|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
1041082|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
1041083|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
1041084|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
1041085|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
1041086|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
1041087|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
1041088|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
1041089|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
1041090|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
1041091|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
1041092|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
1041093|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
1041094|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
1041095|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
1041096|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
1041097|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
1041098|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
1041099|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
1041100|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
1041101|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
1041102|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
1041103|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
1041104|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
1041105|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
1041106|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
1041107|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
1041108|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
1041109|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
1041110|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
1041111|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
1041112|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
1041113|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
1041114|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
1041115|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
1041116|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
1041117|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
1041118|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
1041119|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
1041120|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
1041121|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
1041122|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
1041123|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
1041124|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
1041125|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
1041126|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
1041127|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
1041128|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
1041129|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
1041130|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
1041131|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
1041132|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
1041133|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
1041134|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
1041135|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
1041136|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
1041137|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
1041138|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
1041139|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
1041140|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
1041141|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
1041142|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
1041143|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
1041144|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
1041145|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
1041146|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
1041147|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
1041148|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
1041149|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
1041150|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
1041151|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
1041152|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
1041153|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
1041154|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
1041155|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
1041156|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
1041157|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
1041158|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
1041159|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
1041160|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
1041161|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
1041162|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
1041163|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
1041164|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
1041165|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
1041166|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
1041167|NCT00715403|O7|Outcome|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
1041168|NCT00715403|O6|Outcome|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
1041169|NCT00715403|O5|Outcome|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
1041170|NCT00715403|O4|Outcome|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
1041171|NCT00715403|O3|Outcome|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
1041172|NCT00715403|O2|Outcome|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
1041173|NCT00715403|O1|Outcome|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
1041174|NCT00715403|E7|Reported Event|300mg BID|Patients were treated with 300 mg Nintedanib twice daily.
1041175|NCT00715403|E6|Reported Event|250mg BID|Patients were treated with 250 mg Nintedanib twice daily.
1041176|NCT00715403|E5|Reported Event|200mg BID|Patients were treated with 200 mg Nintedanib twice daily.
1041177|NCT00715403|E4|Reported Event|150mg BID|Patients were treated with 150 mg Nintedanib twice daily.
1041178|NCT00715403|E3|Reported Event|100mg BID|Patients were treated with 100 mg Nintedanib twice daily.
1041179|NCT00715403|E2|Reported Event|200mg QD|Patients were treated with 200 mg Nintedanib once daily in the morning.
1041180|NCT00715403|E1|Reported Event|50mg QD|Patients were treated with 50 mg Nintedanib once daily in the morning.
1041181|NCT00715390|B1|Baseline|Children With Dysrhythmia Events During Anesthesia|The sample of patients screened will be the entire electronic anesthesia record database from 1998 until 2004 looking for subjects that have dysrhythmias.
1041182|NCT00715390|P1|Participant Flow|Children With Dysrhythmia Events During Anesthesia|The sample of patients screened will be the entire electronic anesthesia record database from 1998 until 2004 looking for subjects that have dysrhythmias.
1041183|NCT00715390|O1|Outcome|Children With Dysrhythmia Events During Anesthesia|The sample of patients screened will be the entire electronic anesthesia record database from 1998 until 2004 looking for subjects that have dysrhythmias.
1041184|NCT00715390|E1|Reported Event|Children With Dysrhythmia Events During Anesthesia|The sample of patients screened will be the entire electronic anesthesia record database from 1998 until 2004 looking for subjects that have dysrhythmias.
1041185|NCT00715299|B1|Baseline|Arm 1|"persons who have sustained a stroke within greater than 6 months ago and less than 5 years.~locomotor training: Persons will train 3 times a week for 12 weeks. The training sessions will each last about an hour to an hour and a half. Therapists will manipulate the participant's body to generate stepping and walking that is more consistent with normal walking. Someone will manipulate the trunk by standing at the waist and helping with weight shift and proper upper body mechanics. The other two therapists will sit at the legs and bend and extend them as they should in a more normal gait pattern."
1041186|NCT00715299|P1|Participant Flow|Total Locomotor Training Group|"persons who have sustained a stroke within greater than 6 months ago and less than 5 years.~locomotor training: Persons will train 3 times a week for 12 weeks. The training sessions will each last about an hour to an hour and a half. Therapists will manipulate the participant's body to generate stepping and walking that is more consistent with normal walking. Someone will manipulate the trunk by standing at the waist and helping with weight shift and proper upper body mechanics. The other two therapists will sit at the legs and bend and extend them as they should in a more normal gait pattern."
1041187|NCT00715299|O1|Outcome|Locomotor Training Group|"persons who have sustained a stroke within greater than 6 months ago and less than 5 years.~locomotor training: Persons will train 3 times a week for 12 weeks. The training sessions will each last about an hour to an hour and a half. Therapists will manipulate the participant's body to generate stepping and walking that is more consistent with normal walking. Someone will manipulate the trunk by standing at the waist and helping with weight shift and proper upper body mechanics. The other two therapists will sit at the legs and bend and extend them as they should in a more normal gait pattern.~18 responded with a walking speed greater than 0.16 m/s, while 9 has a change < 0.16 m/s."
1041188|NCT00715299|E1|Reported Event|Arm 1|"persons who have sustained a stroke within greater than 6 months ago and less than 5 years.~locomotor training: Persons will train 3 times a week for 12 weeks. The training sessions will each last about an hour to an hour and a half. Therapists will manipulate the participant's body to generate stepping and walking that is more consistent with normal walking. Someone will manipulate the trunk by standing at the waist and helping with weight shift and proper upper body mechanics. The other two therapists will sit at the legs and bend and extend them as they should in a more normal gait pattern."
1041189|NCT00715208|B3|Baseline|Total|Total of all reporting groups
1041190|NCT00715208|B2|Baseline|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
1041191|NCT00715208|B1|Baseline|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
1041192|NCT00715208|P2|Participant Flow|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
1041193|NCT00715208|P1|Participant Flow|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
1041194|NCT00715208|O2|Outcome|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
1041195|NCT00715208|O1|Outcome|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
1041196|NCT00715208|O2|Outcome|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
1041197|NCT00715208|O1|Outcome|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
1041198|NCT00715208|O2|Outcome|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
1041199|NCT00715208|O1|Outcome|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
1041200|NCT00715208|O2|Outcome|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
1041201|NCT00715208|O1|Outcome|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
1041202|NCT00715208|O2|Outcome|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
1041203|NCT00715208|O1|Outcome|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
1041204|NCT00715208|E2|Reported Event|VELCADE R-CP|VELCADE, rituximab, cyclophosphamide, and prednisone
1041205|NCT00715208|E1|Reported Event|VELCADE R-CAP|VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
1041206|NCT00715117|B3|Baseline|Total|Total of all reporting groups
1041207|NCT00715117|B2|Baseline|B: Naltrexone, Active Drug Group|Naltrexone 0.1 mg/kg (not to exceed 4.5mg) once a day for 16 weeks
1041208|NCT00715117|B1|Baseline|A: Placebo Control Group|Subjects will receive placebo for for the first 8weeks then be crossed over to active drug for the last 8 weeks
1041209|NCT00715117|P2|Participant Flow|B: Naltrexone Then Naltrexone|Naltrexone 0.1 mg/kg (not to exceed 4.5mg) once a day for 8 weeks followed by the same treatment for an additional 8 weeks
1041210|NCT00715117|P1|Participant Flow|A: Placebo Then Naltrexone|Subjects will receive placebo for for the first 8weeks then be crossed over to active drug naltrexone for the last 8 weeks
1041211|NCT00715117|O2|Outcome|Naltrexone|These subjects were treated with naltrexone at a dose 0.1 mg/kg not to exceed 4.5 mg po daily for either 8 or 16 weeks.
1041212|NCT00715117|O1|Outcome|Placebo|These subjects received placebo for 8 weeks by mouth daily.
1041213|NCT00715117|O2|Outcome|Week 16|Quality of life survey values in all subjects determined at week 16 after all 12 participants had received naltrexone for either 8 or 16 weeks.
1041214|NCT00715117|O1|Outcome|Baseline|Quality of life values in all subjects at baseline before receiving placebo or naltrexone.
1041215|NCT00715117|O3|Outcome|Naltrexone|Includes all Naltrexone treated participants 8 weeks of treatment.
1041216|NCT00715117|O2|Outcome|Placebo|Patients were treated with a placebo (sugar pill)for 8 weeks.
1041217|NCT00715117|O1|Outcome|All Participants Pretreament|All participants prior to receiving placebo or naltrexone at week 0
1041218|NCT00715117|E2|Reported Event|B: Naltrexone, Active Drug Group|Naltrexone 0.1 mg/kg (not to exceed 4.5mg) once a day for 8 or 16 weeks
1041219|NCT00715117|E1|Reported Event|A: Placebo Control Group|Subjects will receive placebo for 8weeks
1041220|NCT00715104|B4|Baseline|Total|Total of all reporting groups
1041221|NCT00715104|B3|Baseline|Sipuleucel-T Without Randomization to Booster|Subjects received 3 infusions of sipuleucel-T 12 weeks prior to RP, and declined participation in the post-RP booster phase(received no further sipuleucel-T treatment).
1041222|NCT00715104|B2|Baseline|Sipuleucel-T Without Booster|Subjects received 3 infusions of sipuleucel-T 12 weeks prior to RP, with no further sipuleucel-T treatment.
1041223|NCT00715104|B1|Baseline|Sipuleucel-T With Booster|Subjects received 3 infusions of sipuleucel-T 12 weeks prior to RP, and then an additional booster infusion 13 weeks following RP.
1041224|NCT00715104|P3|Participant Flow|Sipuleucel-T Without Randomization to Booster|Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, and declined participation in the post-RP booster phase (received no further sipuleucel-T treatment).
1041225|NCT00715104|P2|Participant Flow|Sipuleucel-T Without Booster|Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, with no further sipuleucel-T treatment.
1041226|NCT00715104|P1|Participant Flow|Sipuleucel-T With Booster|Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, and then an additional booster infusion 13 weeks following RP.
1041227|NCT00715104|O8|Outcome|No Booster: 72 Weeks Post-RP|ELISPOT for PAP measured at 72 Weeks Post-RP for subjects randomized to no booster
1041228|NCT00715104|O7|Outcome|Booster: 72 Weeks Post-RP|ELISPOT for PAP measured at 72 Weeks Post-RP for subjects randomized to booster
1041229|NCT00715104|O6|Outcome|No Booster: 48 Weeks Post-RP|ELISPOT for PAP measured at 48 Weeks Post-RP for subjects randomized to no booster
1041230|NCT00715104|O5|Outcome|Booster: 48 Weeks Post-RP|ELISPOT for PAP measured at 48 Weeks Post-RP for subjects randomized to booster
1041231|NCT00715104|O4|Outcome|No Booster: 24 Weeks Post-RP|ELISPOT for PAP measured at 24 Weeks Post-RP for subjects randomized to no booster
1041232|NCT00715104|O3|Outcome|Booster: 24 Weeks Post-RP|ELISPOT for PAP measured at 24 Weeks Post-RP for subjects randomized to booster
1041233|NCT00715104|O2|Outcome|No Booster: 12 Weeks Post-RP/Pre-Booster|ELISPOT for PAP measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to no booster
1041234|NCT00715104|O1|Outcome|Booster: 12 Weeks Post-RP/Pre-Booster|ELISPOT for PAP measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to booster
1041235|NCT00715104|O8|Outcome|No Booster: 72 Weeks Post-RP|ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to no booster
1041236|NCT00715104|O7|Outcome|Booster: 72 Weeks Post-RP|ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to booster
1041237|NCT00715104|O6|Outcome|No Booster: 48 Weeks Post-RP|ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to no booster
1041238|NCT00715104|O5|Outcome|Booster: 48 Weeks Post-RP|ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to booster
1041239|NCT00715104|O4|Outcome|No Booster: 24 Weeks Post-RP|ELISPOT for PA2024 measured at 24 Weeks Post-RP for subjects randomized to no booster
1041240|NCT00715104|O3|Outcome|Booster: 24 Weeks Post-RP|ELISPOT for PA2024 measured at 24 Weeks Post-RP for subjects randomized to booster
1041241|NCT00715104|O2|Outcome|No Booster: 12 Weeks Post-RP/Pre-Booster|ELISPOT for PA2024 measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to no booster
1041242|NCT00715104|O1|Outcome|Booster: 12 Weeks Post-RP/Pre-Booster|ELISPOT for PA2024 measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to booster
1041243|NCT00715104|O4|Outcome|72 Weeks Post-RP|ELISPOT for PAP measured at 72 Weeks Post-RP for subjects randomized to booster
1041244|NCT00715104|O3|Outcome|48 Weeks Post-RP|ELISPOT for PAP measured at 48 Weeks Post-RP for subjects randomized to booster
1041245|NCT00715104|O2|Outcome|24 Weeks Post-RP|ELISPOT for PAP measured at 24 Weeks Post-RP for subjects randomized to booster
1041246|NCT00715104|O1|Outcome|12 Weeks Post-RP/Pre-Booster|ELISPOT for PAP measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to booster
1041247|NCT00715104|O4|Outcome|72 Weeks Post-RP|ELISPOT for PA2024 measured at 72 Weeks Post-RP for subjects randomized to booster
1041248|NCT00715104|O3|Outcome|48 Weeks Post-RP|ELISPOT for PA2024 measured at 48 Weeks Post-RP for subjects randomized to booster
1041249|NCT00715104|O2|Outcome|24 Weeks Post-RP|ELISPOT for PA2024 measured at 24 Weeks Post-RP for subjects randomized to booster
1041250|NCT00715104|O1|Outcome|12 Weeks Post-RP/Pre-Booster|ELISPOT for PA2024 measured at 12 Weeks Post-RP/Pre-Booster for subjects randomized to booster
1041251|NCT00715104|O4|Outcome|12 Weeks Post-RP|ELISPOT for PAP at 12 Weeks post-RP
1041252|NCT00715104|O3|Outcome|6 Weeks Post-RP|ELISPOT for PAP at 6 Weeks post-RP
1041253|NCT00715104|O2|Outcome|Pre-RP Visit|ELISPOT for PAP at pre-RP visit
1041254|NCT00715104|O1|Outcome|Baseline|ELISPOT for PAP at baseline
1041255|NCT00715104|O4|Outcome|12 Weeks Post-RP|ELISPOT for PA2024 at 12 Weeks post-RP
1041256|NCT00715104|O3|Outcome|6 Weeks Post-RP|ELISPOT for PA2024 at 6 Weeks post-RP
1041257|NCT00715104|O2|Outcome|Pre-RP Visit|ELISPOT for PA2024 at Pre-RP Visit
1041258|NCT00715104|O1|Outcome|Baseline|ELISPOT for PA2024 at baseline
1041259|NCT00715104|O4|Outcome|Post-RP Tumor Interface Tissue|Tumor interface (the junction of normal and malignant) tissue from post-treatment with sipuleucel-T and post-RP
1041260|NCT00715104|O3|Outcome|Post-RP Tumor Tissue|Tumor tissue from post-treatment with sipuleucel-T and post-RP
1041261|NCT00715104|O2|Outcome|Post-RP Benign Tissue|Benign tissue from post-treatment with sipuleucel-T and post-RP
1041262|NCT00715104|O1|Outcome|Biopsy Benign Tissue|Tissue from the core biopsy specimen obtained prior to treatment with sipuleucel-T
1041263|NCT00715104|O4|Outcome|Post-RP Tumor Interface Tissue|Tumor interface (the junction of normal and malignant) tissue from post-treatment with sipuleucel-T and post-RP
1053929|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
1041264|NCT00715104|O3|Outcome|Post-RP Tumor Tissue|Tumor tissue from post-treatment with sipuleucel-T and post-RP
1041265|NCT00715104|O2|Outcome|Post-RP Benign Tissue|Benign tissue from post-treatment with sipuleucel-T and post-RP
1041266|NCT00715104|O1|Outcome|Biopsy Benign Tissue|Tissue from the core biopsy specimen obtained prior to treatment with sipuleucel-T
1041267|NCT00715104|O4|Outcome|Post-RP Tumor Interface|Tumor interface (the junction of normal and malignant) tissue from post-treatment with sipuleucel-T and post-RP
1041268|NCT00715104|O3|Outcome|Post-RP Tumor Tissue|Tumor tissue from post-treatment with sipuleucel-T and post-RP
1041269|NCT00715104|O2|Outcome|Post-RP Benign Tissue|Benign tissue from post-treatment with sipuleucel-T and post-RP
1041270|NCT00715104|O1|Outcome|Biopsy Benign Tissue|Tissue from the core biopsy specimen obtained prior to treatment with sipuleucel-T
1041271|NCT00715104|E3|Reported Event|Sipuleucel-T Without Randomization to Booster|Subjects received 3 infusions of sipuleucel-T 12 weeks prior to RP, and declined participation in the post-RP booster phase (received no further sipuleucel-T treatment).
1041272|NCT00715104|E2|Reported Event|Sipuleucel-T Without Booster|Subjects received 3 infusions of sipuleucel-T 12 weeks prior to RP, with no further sipuleucel-T treatment.
1041273|NCT00715104|E1|Reported Event|Sipuleucel-T With Booster|Subjects receive 3 infusions of sipuleucel-T 12 weeks prior to RP, and then received an additional booster infusion 13 weeks after RP.
1041274|NCT00715078|B4|Baseline|Total|Total of all reporting groups
1041275|NCT00715078|B3|Baseline|Cohort C|Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
1041276|NCT00715078|B2|Baseline|Cohort B|Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
1041277|NCT00715078|B1|Baseline|Cohort A|Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
1041278|NCT00715078|P3|Participant Flow|Cohort C|Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
1041279|NCT00715078|P2|Participant Flow|Cohort B|Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
1041280|NCT00715078|P1|Participant Flow|Cohort A|Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
1041281|NCT00715078|O3|Outcome|Cohort C|Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
1041282|NCT00715078|O2|Outcome|Cohort B|Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
1041283|NCT00715078|O1|Outcome|Cohort A|Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
1041284|NCT00715078|E3|Reported Event|Cohort C|Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL
1041285|NCT00715078|E2|Reported Event|Cohort B|Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL
1041286|NCT00715078|E1|Reported Event|Cohort A|Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10^7 peripheral blood mononuclear cells (PBMCs) per mL
1041287|NCT00715026|B1|Baseline|Trilogy AB Acetabular Hip Implant System|"Post Approval Study of Device.~Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces."
1041288|NCT00715026|P1|Participant Flow|Trilogy AB Acetabular Hip Implant System|"Post Approval Study of Device.~Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces."
1041289|NCT00715026|O1|Outcome|Trilogy AB Acetabular Hip Implant System|"Post Approval Study of Device.~Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces."
1041290|NCT00715026|O1|Outcome|Trilogy AB Acetabular Hip Implant System|"Post Approval Study of Device.~Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces."
1041291|NCT00715026|E1|Reported Event|Trilogy AB Acetabular Hip Implant System|"Post Approval Study of Device.~Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces."
1041292|NCT00714948|B1|Baseline|Gemcitabine and Split-dose Cisplatin + Sorafenib|"This is a phase II trial of gemcitabine and Split-dose cisplatin plus sorafenib.~Gemcitabine 1000 mg/m 2 will be administered on days 1 and 8 and cisplatin 35 mg/m 2 will be administered on days 1 and 8. A total of six cycles of therapy will be administered at 21day intervals. Sorafenib 400 mg PO twice daily will be initiated on day 1 of cycle 1 and continued, as tolerated, until the time of disease progression or a maximum of 12 months."
1041293|NCT00714948|P1|Participant Flow|Gemcitabine and Split-dose Cisplatin + Sorafenib|"This is a phase II trial of gemcitabine and Split-dose cisplatin plus sorafenib.~Gemcitabine 1000 mg/m 2 will be administered on days 1 and 8 and cisplatin 35 mg/m 2 will be administered on days 1 and 8. A total of six cycles of therapy will be administered at 21day intervals. Sorafenib 400 mg PO twice daily will be initiated on day 1 of cycle 1 and continued, as tolerated, until the time of disease progression or a maximum of 12 months."
1041294|NCT00714948|O1|Outcome|Gemcitabine and Split-dose Cisplatin + Sorafenib|"This is a phase II trial of gemcitabine and Split-dose cisplatin plus sorafenib.~Gemcitabine 1000 mg/m 2 will be administered on days 1 and 8 and cisplatin 35 mg/m 2 will be administered on days 1 and 8. A total of six cycles of therapy will be administered at 21day intervals. Sorafenib 400 mg PO twice daily will be initiated on day 1 of cycle 1 and continued, as tolerated, until the time of disease progression or a maximum of 12 months."
1041327|NCT00714688|O3|Outcome|72 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 2 tablets 36 mg once daily for 13 weeks
1041328|NCT00714688|O2|Outcome|54 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 18 + 36 mg once daily for 13 weeks
1041329|NCT00714688|O1|Outcome|Placebo|2 tablets placebo once daily for 13 weeks
1041295|NCT00714948|E1|Reported Event|Gemcitabine and Split-dose Cisplatin + Sorafenib|"This is a phase II trial of gemcitabine and Split-dose cisplatin plus sorafenib.~Gemcitabine 1000 mg/m 2 will be administered on days 1 and 8 and cisplatin 35 mg/m 2 will be administered on days 1 and 8. A total of six cycles of therapy will be administered at 21day intervals. Sorafenib 400 mg PO twice daily will be initiated on day 1 of cycle 1 and continued, as tolerated, until the time of disease progression or a maximum of 12 months."
1041296|NCT00714870|B3|Baseline|Total|Total of all reporting groups
1041297|NCT00714870|B2|Baseline|Control Group|control group: this group will not attend the nutrition and exercise program
1041298|NCT00714870|B1|Baseline|Intervention: Nutrition and Exercise Program|"intervention: this group will attend the nutrition and exercise program control group: this group will not attend the nutrition and exercise program~Behavioral nutrition and exercise program : The intervention consists of a behavioral nutrition and exercise program. Meetings occur monthly on a Saturday afternoon and last 4 hours. During this time we cover: 1)registration: monitoring of sedentary activities and liquid choices, motivational interviewing, exercise testing;2)exercise: includes strength training; 3) educational lectures; 4) didactic games and projects."
1041299|NCT00714870|P2|Participant Flow|Control Group: Standard of Care at Pediatrician's Office|control group: this group will not attend the nutrition and exercise program
1041300|NCT00714870|P1|Participant Flow|Intervention: Nutrition and Exercise Program|"intervention: this group will attend the nutrition and exercise program~Behavioral nutrition and exercise program : The intervention consists of a behavioral nutrition and exercise program. Meetings occur monthly on a Saturday afternoon and last 4 hours. During this time we cover: 1)registration: monitoring of sedentary activities and liquid choices, motivational interviewing, exercise testing;2)exercise: includes strength training; 3) educational lectures; 4) didactic games and projects."
1041301|NCT00714870|O2|Outcome|Control|Control group received the standard of care at pediatrician's office
1041302|NCT00714870|O1|Outcome|Intervention: Nutrition and Exercise Program|"intervention: this group will attend the nutrition and exercise program control group: this group will not attend the nutrition and exercise program~Behavioral nutrition and exercise program : The intervention consists of a behavioral nutrition and exercise program. Meetings occur monthly on a Saturday afternoon and last 4 hours. During this time we cover: 1)registration: monitoring of sedentary activities and liquid choices, motivational interviewing, exercise testing;2)exercise: includes strength training; 3) educational lectures; 4) didactic games and projects."
1041303|NCT00714870|E2|Reported Event|Control|
1041304|NCT00714870|E1|Reported Event|Intervention: Nutrition and Exercise Program|"intervention: this group will attend the nutrition and exercise program control group: this group will not attend the nutrition and exercise program~Behavioral nutrition and exercise program : The intervention consists of a behavioral nutrition and exercise program. Meetings occur monthly on a Saturday afternoon and last 4 hours. During this time we cover: 1)registration: monitoring of sedentary activities and liquid choices, motivational interviewing, exercise testing;2)exercise: includes strength training; 3) educational lectures; 4) didactic games and projects."
1041305|NCT00714792|B3|Baseline|Total|Total of all reporting groups
1041306|NCT00714792|B2|Baseline|Control Subjects|Control subjects
1041307|NCT00714792|B1|Baseline|Overactive Bladder Subjects|Subjects with urge incontinence due to overactive bladder
1041308|NCT00714792|P2|Participant Flow|Control Subjects|Control subjects
1041309|NCT00714792|P1|Participant Flow|Overactive Bladder Subjects|Subjects with urge incontinence due to overactive bladder
1041310|NCT00714792|O2|Outcome|Control Subjects|
1041311|NCT00714792|O1|Outcome|Overactive Bladder Subjects|
1041312|NCT00714792|E2|Reported Event|Control Subjects|Control subjects
1041313|NCT00714792|E1|Reported Event|Overactive Bladder Subjects|Subjects with urge incontinence due to overactive bladder
1041314|NCT00714714|B1|Baseline|Combined Arms|All subjects received treatment with both gels in a split-face model
1041315|NCT00714714|P1|Participant Flow|Combined Arms|All subjects received treatment with both gels in a split-face model
1041316|NCT00714714|O2|Outcome|Tretinoin|Tretinoin facial gel was applied daily to the opposite side of the face of all subjects in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (deep). Also on weekdays during the two-week trial, subjects performed a self-assessment of Burning/stinging and Itching, which were scored on a scale of 0 (none) to 3 (severe).
1041317|NCT00714714|O1|Outcome|Adapalene|Adapalene facial gel was applied daily to one side of the face of all subjects in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (deep). Also on weekdays during the two-week trial, subjects performed a self-assessment of Burning/stinging and Itching, which were scored on a scale of 0 (none) to 3 (severe).
1041318|NCT00714714|E2|Reported Event|Tretinion|Tretinoin facial gel was applied daily to the opposite side of the face of all subjects in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (deep). Also on weekdays during the two-week trial, subjects performed a self-assessment of Burning/stinging and Itching, which were scored on a scale of 0 (none) to 3 (severe).
1041319|NCT00714714|E1|Reported Event|Adapalene|Adapalene facial gel was applied daily to one side of the face of all subjects in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (deep). Also on weekdays during the two-week trial, subjects performed a self-assessment of Burning/stinging and Itching, which were scored on a scale of 0 (none) to 3 (severe).
1041320|NCT00714688|B4|Baseline|Total|Total of all reporting groups
1041321|NCT00714688|B3|Baseline|72 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 2 tablets 36 mg once daily for 13 weeks
1041322|NCT00714688|B2|Baseline|54 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 18 + 36 mg once daily for 13 weeks
1041323|NCT00714688|B1|Baseline|Placebo|2 tablets placebo once daily for 13 weeks
1041324|NCT00714688|P3|Participant Flow|72 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 2 tablets 36 mg once daily for 13 weeks
1041325|NCT00714688|P2|Participant Flow|54 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 18 + 36 mg once daily for 13 weeks
1041326|NCT00714688|P1|Participant Flow|Placebo|2 tablets placebo once daily for 13 weeks
1041330|NCT00714688|O3|Outcome|72 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 2 tablets 36 mg once daily for 13 weeks
1041331|NCT00714688|O2|Outcome|54 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 18 + 36 mg once daily for 13 weeks
1041332|NCT00714688|O1|Outcome|Placebo|2 tablets placebo once daily for 13 weeks
1041333|NCT00714688|O3|Outcome|72 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 2 tablets 36 mg once daily for 13 weeks
1041334|NCT00714688|O2|Outcome|54 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 18 + 36 mg once daily for 13 weeks
1041335|NCT00714688|O1|Outcome|Placebo|2 tablets placebo once daily for 13 weeks
1041336|NCT00714688|O3|Outcome|72 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 2 tablets 36 mg once daily for 13 weeks
1041337|NCT00714688|O2|Outcome|54 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 18 + 36 mg once daily for 13 weeks
1041338|NCT00714688|O1|Outcome|Placebo|2 tablets placebo once daily for 13 weeks
1041339|NCT00714688|E3|Reported Event|72 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 2 tablets 36 mg once daily for 13 weeks
1041340|NCT00714688|E2|Reported Event|54 mg PR OROS MPH|Prolonged-release (PR) OROS methylphenidate 18 + 36 mg once daily for 13 weeks
1041341|NCT00714688|E1|Reported Event|Placebo|2 tablets placebo once daily for 13 weeks
1041342|NCT00714571|B7|Baseline|Total|Total of all reporting groups
1041343|NCT00714571|B6|Baseline|SCT Healthy Older Adults: Stage 2|Subtracting cues training for face name associations in healthy older adults
1041344|NCT00714571|B5|Baseline|MST Healthy Older Adults: Stage 2|Mnemonic strategy training for face name associations in healthy older adults
1041345|NCT00714571|B4|Baseline|XP MCI: Stage 1|Repeated exposure for object location associations in patients with MCI
1041346|NCT00714571|B3|Baseline|XP Healthy Older Adults: Stage 1|Repeated exposure for object location associations in healthy older adults
1041347|NCT00714571|B2|Baseline|MST MCI: Stage 1|Mnemonic strategy training for object location associations in patients with MCI
1041348|NCT00714571|B1|Baseline|MST Healthy Older Adults: Stage 1|Mnemonic strategy training for object location associations for healthy older adults
1041349|NCT00714571|P6|Participant Flow|SCT Healthy Older Adults: Stage 2|Subtracting cues training for face name associations in healthy older adults
1041350|NCT00714571|P5|Participant Flow|MST Healthy Older Adults: Stage 2|Mnemonic strategy training for face name associations in healthy older adults
1041351|NCT00714571|P4|Participant Flow|XP MCI: Stage 1|Repeated exposure for object location associations in patients with MCI
1041352|NCT00714571|P3|Participant Flow|XP Healthy Older Adults: Stage 1|Repeated exposure for object location associations in healthy older adults
1041353|NCT00714571|P2|Participant Flow|MST MCI: Stage 1|Mnemonic strategy training for object location associations in patients with MCI
1041354|NCT00714571|P1|Participant Flow|MST Healthy Older Adults: Stage 1|Mnemonic strategy training for object location associations for healthy older adults
1041355|NCT00714571|O6|Outcome|SCT Healthy Older Adults: Stage 2|Subtracting cues training for face name associations in healthy older adults
1041356|NCT00714571|O5|Outcome|MST Healthy Older Adults: Stage 2|Mnemonic strategy training for face name associations in healthy older adults
1041357|NCT00714571|O4|Outcome|XP MCI: Stage 1|Repeated exposure for object location associations in patients with MCI
1041358|NCT00714571|O3|Outcome|XP Healthy Older Adults: Stage 1|Repeated exposure for object location associations in healthy older adults
1041359|NCT00714571|O2|Outcome|MST MCI: Stage 1|Mnemonic strategy training for object location associations in patients with MCI
1041360|NCT00714571|O1|Outcome|MST Healthy Older Adults: Stage 1|Mnemonic strategy training for object location associations for healthy older adults
1041361|NCT00714571|E6|Reported Event|SCT Healthy Older Adults: Stage 2|Subtracting cues training for face name associations in healthy older adults
1041362|NCT00714571|E5|Reported Event|MST Healthy Older Adults: Stage 2|Mnemonic strategy training for face name associations in healthy older adults
1041363|NCT00714571|E4|Reported Event|XP MCI: Stage 1|Repeated exposure for object location associations in patients with MCI
1041364|NCT00714571|E3|Reported Event|XP Healthy Older Adults: Stage 1|Repeated exposure for object location associations in healthy older adults
1041365|NCT00714571|E2|Reported Event|MST MCI: Stage 1|Mnemonic strategy training for object location associations in patients with MCI
1041366|NCT00714571|E1|Reported Event|MST Healthy Older Adults: Stage 1|Mnemonic strategy training for object location associations for healthy older adults
1041367|NCT00714493|B1|Baseline|Infliximab|Infliximab 3 mg/kg (intravenously) at weeks 0,2,6; Increase to 5 mg/kg (i.v.) or 7 mg/kg (i.v.) based on EULAR response
1041368|NCT00714493|P1|Participant Flow|Infliximab|Infliximab 3 mg/kg (intravenously) at weeks 0,2,6; Increase to 5 mg/kg (i.v.) or 7 mg/kg (i.v.) based on EULAR response
1041369|NCT00714493|O1|Outcome|Infliximab 3 mg/kg|Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
1041370|NCT00714493|O1|Outcome|Infliximab 3 mg/kg|Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
1041371|NCT00714493|O1|Outcome|Infliximab 3 mg/kg|Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
1041372|NCT00714493|O1|Outcome|Infliximab 3 mg/kg|Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
1041373|NCT00714493|O1|Outcome|Infliximab 3 mg/kg|Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
1041374|NCT00714493|O1|Outcome|Infliximab 3 mg/kg|Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
1041375|NCT00714493|O1|Outcome|Infliximab 3 mg/kg|Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
1041376|NCT00714493|E1|Reported Event|Infliximab|Infliximab 3 mg/kg (intravenously) at weeks 0,2,6; Increase to 5 mg/kg (i.v.) or 7 mg/kg (i.v.) based on EULAR response
1041377|NCT00714389|B1|Baseline|Spontaneous Uroflow Measurements|Spontaneous voids of subjects were recorded using uroflowmetry.
1041378|NCT00714389|P1|Participant Flow|Spontaneous Uroflow Measurements|Spontaneous voids of volunteers working in the care facility will recorded by uroflowmetry.
1041379|NCT00714389|O1|Outcome|Spontaneous Uroflow Measurements|Spontaneous voids of subjects were recorded using uroflowmetry.
1041380|NCT00714389|O1|Outcome|Spontaneous Uroflow Measurements|Spontaneous voids of subjects were recorded using uroflowmetry.
1041381|NCT00714389|E1|Reported Event|Spontaneous Uroflow Measurements|Spontaneous voids of subjects were recorded using uroflowmetry.
1041382|NCT00714311|B3|Baseline|Total|Total of all reporting groups
1041383|NCT00714311|B2|Baseline|Experienced Community Psychotherapists|Experienced Community Psychotherapists (ECP)
1041384|NCT00714311|B1|Baseline|Transferenced-Focused Psychotherapy|Transferenced-Focused Psychotherapy (TFP)
1041385|NCT00714311|P2|Participant Flow|Experienced Community Psychotherapists|Experienced Community Psychotherapists (ECP)
1041386|NCT00714311|P1|Participant Flow|Transferenced-Focused Psychotherapy|Transferenced-Focused Psychotherapy (TFP)
1041387|NCT00714311|O2|Outcome|Experienced Community Psychotherapists|Experienced Community Psychotherapists (ECP)
1041388|NCT00714311|O1|Outcome|Transferenced-Focused Psychotherapy|Transferenced-Focused Psychotherapy (TFP)
1041389|NCT00714311|E2|Reported Event|Treatment by Experienced Community Psychotherapists|"treatment by experienced community psychotherapists (ECP)~treatment by experienced community psychotherapists: Outpatient psychotherapy in private practices or outpatient units of psychiatric hospitals. Licensed psychotherapists with experience and special interest in the treatment of borderline patients are treating according to the method they have learned."
1041390|NCT00714311|E1|Reported Event|Transference-Focused Psychotherapy|"Transference-Focused Psychotherapy (TFP)~Transference-Focused Psychotherapy: Outpatient psychotherapy according to the treatment manual, sessions of 50 minutes twice per week"
1041391|NCT00714285|B5|Baseline|Total|Total of all reporting groups
1041392|NCT00714285|B4|Baseline|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041393|NCT00714285|B3|Baseline|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041394|NCT00714285|B2|Baseline|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041395|NCT00714285|B1|Baseline|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041396|NCT00714285|P4|Participant Flow|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041397|NCT00714285|P3|Participant Flow|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041398|NCT00714285|P2|Participant Flow|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041399|NCT00714285|P1|Participant Flow|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041400|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041401|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041402|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041403|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041404|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041405|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041406|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041407|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041408|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041409|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041410|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041460|NCT00714233|B3|Baseline|Lifestyle Counseling|lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
1041462|NCT00714233|B1|Baseline|Metformin|Randomized to Metformin 1700mg daily for 24 weeks
1041411|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041412|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041413|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041414|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041415|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041416|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041417|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041418|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041419|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041420|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041421|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041422|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041423|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041424|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041425|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041426|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041427|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041428|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041429|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041430|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041431|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041432|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041433|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041434|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041435|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041436|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041437|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041461|NCT00714233|B2|Baseline|Oral Contraceptive|Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
1041438|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041439|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041440|NCT00714285|O4|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041441|NCT00714285|O3|Outcome|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0.
1041442|NCT00714285|O2|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041443|NCT00714285|O1|Outcome|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041444|NCT00714285|E4|Reported Event|Trivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 full dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041445|NCT00714285|E3|Reported Event|Trivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 low dose of GSK Biologicals’ trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041446|NCT00714285|E2|Reported Event|Quadrivalent Influenza Vaccine GSK 2115160A Group 2|Subjects in this group received 1 low dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041447|NCT00714285|E1|Reported Event|Quadrivalent Influenza Vaccine GSK 2115160A Group 1|Subjects in this group received 1 full dose of GSK Biologicals’ quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
1041448|NCT00714259|B1|Baseline|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section~Fludarabine: Fludarabine 30 mg/m2/day x 3 days~Total Body Irradiation: TBI 200cGy x1 dose on transplant day~Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
1041449|NCT00714259|P1|Participant Flow|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section~Fludarabine: Fludarabine 30 mg/m2/day x 3 days~Total Body Irradiation: TBI 200cGy x1 dose on transplant day~Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
1041450|NCT00714259|O1|Outcome|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section~Fludarabine: Fludarabine 30 mg/m2/day x 3 days~Total Body Irradiation: TBI 200cGy x1 dose on transplant day~Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
1041451|NCT00714259|O1|Outcome|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section~Fludarabine: Fludarabine 30 mg/m2/day x 3 days~Total Body Irradiation: TBI 200cGy x1 dose on transplant day~Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
1041452|NCT00714259|O1|Outcome|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section~Fludarabine: Fludarabine 30 mg/m2/day x 3 days~Total Body Irradiation: TBI 200cGy x1 dose on transplant day~Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
1041453|NCT00714259|O1|Outcome|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section~Fludarabine: Fludarabine 30 mg/m2/day x 3 days~Total Body Irradiation: TBI 200cGy x1 dose on transplant day~Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
1041454|NCT00714259|O1|Outcome|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section~Fludarabine: Fludarabine 30 mg/m2/day x 3 days~Total Body Irradiation: TBI 200cGy x1 dose on transplant day~Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
1041455|NCT00714259|O1|Outcome|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section~Fludarabine: Fludarabine 30 mg/m2/day x 3 days~Total Body Irradiation: TBI 200cGy x1 dose on transplant day~Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
1041456|NCT00714259|O1|Outcome|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section~Fludarabine: Fludarabine 30 mg/m2/day x 3 days~Total Body Irradiation: TBI 200cGy x1 dose on transplant day~Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
1041457|NCT00714259|E1|Reported Event|Single Arm Trial|"Single Arm Intervention trial as noted in interventions section~Fludarabine: Fludarabine 30 mg/m2/day x 3 days~Total Body Irradiation: TBI 200cGy x1 dose on transplant day~Infusion of Stem Cells: On Day 0 pts will received an infusion of HLA matched sibling donor stem cells. Dose is determined by the volume of cells obtained from donor. Minimum dose is 2x10*6 CD34+ cells per kilogram of recipient weight."
1041458|NCT00714233|B5|Baseline|Total|Total of all reporting groups
1041459|NCT00714233|B4|Baseline|Placebo to Metformin|randomized to placebo pill identical to active metformin arm
1041463|NCT00714233|P4|Participant Flow|Placebo to Metformin|randomized to placebo pill identical to active metformin arm
1041464|NCT00714233|P3|Participant Flow|Lifestyle Counseling|lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
1041465|NCT00714233|P2|Participant Flow|Oral Contraceptive|Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
1041466|NCT00714233|P1|Participant Flow|Metformin|Randomized to Metformin 1700mg daily for 24 weeks
1041467|NCT00714233|O4|Outcome|Placebo to Metformin|randomized to placebo pill identical to active metformin arm
1041468|NCT00714233|O3|Outcome|Lifestyle Counseling|lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
1041469|NCT00714233|O2|Outcome|Oral Contraceptive|Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
1041470|NCT00714233|O1|Outcome|Metformin|Randomized to Metformin 1700mg daily for 24 weeks
1041471|NCT00714233|O4|Outcome|Placebo to Metformin|randomized to placebo pill identical to active metformin arm
1041472|NCT00714233|O3|Outcome|Lifestyle Counseling|lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
1041473|NCT00714233|O2|Outcome|Oral Contraceptive|Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
1041474|NCT00714233|O1|Outcome|Metformin|Randomized to Metformin 1700mg daily for 24 weeks
1041475|NCT00714233|O4|Outcome|Placebo to Metformin|randomized to placebo pill identical to active metformin arm
1041476|NCT00714233|O3|Outcome|Lifestyle Counseling|lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
1041477|NCT00714233|O2|Outcome|Oral Contraceptive|Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
1041478|NCT00714233|O1|Outcome|Metformin|Randomized to Metformin 1700mg daily for 24 weeks
1041479|NCT00714233|O4|Outcome|Placebo to Metformin|Matched to metformin pill
1041480|NCT00714233|O3|Outcome|Lifestle|Those assigned to a nutrition and exercise program
1041481|NCT00714233|O2|Outcome|Oral Contraceptive|group assigned to oral contraceptive for 24 weeks
1041482|NCT00714233|O1|Outcome|Metformin|Group assigned to metformin with free androgen index measured
1041483|NCT00714233|O1|Outcome|Lifestyle Program|Subjects enrolled in a nutrition and exercise program
1041484|NCT00714233|O4|Outcome|Placebo to Metformin|randomized to placebo pill identical to active metformin arm
1041485|NCT00714233|O3|Outcome|Lifestyle Counseling|lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
1041486|NCT00714233|O2|Outcome|Oral Contraceptive|Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
1041487|NCT00714233|O1|Outcome|Metformin|Randomized to Metformin 1700mg daily for 24 weeks
1041488|NCT00714233|E4|Reported Event|Placebo to Metformin|randomized to placebo pill identical to active metformin arm
1041489|NCT00714233|E3|Reported Event|Lifestyle Counseling|lifestyle modification program consisting of nutritional counseling and dietary counseling meeting weekly
1041490|NCT00714233|E2|Reported Event|Oral Contraceptive|Randomized to Oral Contraceptive Pills for 24 weeks. Monitored monthly for compliance
1041491|NCT00714233|E1|Reported Event|Metformin|Randomized to Metformin 1700mg daily for 24 weeks
1041492|NCT00714168|B3|Baseline|Total|Total of all reporting groups
1041493|NCT00714168|B2|Baseline|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.~Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
1041494|NCT00714168|B1|Baseline|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.~Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
1041495|NCT00714168|P2|Participant Flow|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.~Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
1041496|NCT00714168|P1|Participant Flow|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.~Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
1041497|NCT00714168|O2|Outcome|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.~Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
1041498|NCT00714168|O1|Outcome|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.~Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
1041520|NCT00713830|B1|Baseline|Placebo|2-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
1041521|NCT00713830|P2|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
1042077|NCT00712244|P2|Participant Flow|DUOVISC|DUOVISC® Viscoelastic system
1042082|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
1041499|NCT00714168|O2|Outcome|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.~Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
1041500|NCT00714168|O1|Outcome|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.~Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
1041501|NCT00714168|O2|Outcome|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.~Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
1041502|NCT00714168|O1|Outcome|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.~Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
1041503|NCT00714168|O2|Outcome|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.~Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
1041504|NCT00714168|O1|Outcome|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.~Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
1041505|NCT00714168|O2|Outcome|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.~Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
1041506|NCT00714168|O1|Outcome|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.~Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
1041507|NCT00714168|E2|Reported Event|Stepped-Care Weight Loss Program|"Participants will take part in a stepped-care weight loss program.~Stepped-Care Weight Loss Program : In this program, increases in the intensity of treatment will be based on participants' abilities to achieve predetermined weight loss goals. Participants will initially receive less contact with program staff. The intensity and/or frequency of contact will then increase at 12-week intervals, based on weight loss progress until a 10% weight loss is attained and maintained. The program will stay constant, unless weight loss drops below the 10% level."
1041508|NCT00714168|E1|Reported Event|Standard Behavioral Weight Loss Program|"Participants will take part in a standard behavioral weight loss program.~Standard Behavioral Weight Loss Program : This program will include group sessions that will focus on modifying eating and physical activity behaviors to improve weight loss."
1041509|NCT00714051|B3|Baseline|Total|Total of all reporting groups
1041510|NCT00714051|B2|Baseline|Control Group|The control group participated in four weekly treadmill walking sessions at a self-selected speed.
1041511|NCT00714051|B1|Baseline|Falls Prevention Training Group|The falls prevention training group participated in four weekly training sessions on a custom-built treadmill that produced trip-simulating perturbations (movements). While harnessed overhead to prevent actual falls, the treadmill stopped or moved suddenly. The goal for the participant was to try and prevent a fall. Each week, the level of difficulty of the task was increased.
1041512|NCT00714051|P2|Participant Flow|Control|The control group participated in four weekly treadmill walking sessions at a self-selected speed.
1041513|NCT00714051|P1|Participant Flow|Falls Prevention Training|The falls prevention training group participated in four weekly training sessions on a custom-built treadmill that produced trip-simulating perturbations (movements). While harnessed overhead to prevent actual falls, the treadmill stopped or moved suddenly. The goal for the participant was to try and prevent a fall. Each week, the level of difficulty of the task was increased.
1041514|NCT00714051|O2|Outcome|Attention Control|The control group participated in four weekly treadmill walking sessions at a self-selected speed.
1041515|NCT00714051|O1|Outcome|Falls Prevention Training|The falls prevention training group participated in four weekly training sessions on a custom-built treadmill that produced trip-simulating perturbations (movements). While harnessed overhead to prevent actual falls, the treadmill stopped or moved suddenly. The goal for the participant was to try and prevent a fall. Each week, the level of difficulty of the task was increased.
1041516|NCT00714051|E2|Reported Event|Attention Control|The control group participated in four weekly treadmill walking sessions at a self-selected speed.
1041517|NCT00714051|E1|Reported Event|Falls Prevention Training|The falls prevention training group participated in four weekly training sessions on a custom-built treadmill that produced trip-simulating perturbations (movements). While harnessed overhead to prevent actual falls, the treadmill stopped or moved suddenly. The goal for the participant was to try and prevent a fall. Each week, the level of difficulty of the task was increased.
1041518|NCT00713830|B3|Baseline|Total|Total of all reporting groups
1041519|NCT00713830|B2|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
1042078|NCT00712244|P1|Participant Flow|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
1041522|NCT00713830|P1|Participant Flow|Placebo|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
1041523|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1041524|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1041525|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1041526|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1041527|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1041528|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1041529|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1041530|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1041531|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1041532|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1041533|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1041534|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1041535|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1041536|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1041537|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1041538|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1041539|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1041540|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1041541|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1041542|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1041543|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1041544|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1041545|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1041546|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1041547|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1041548|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1041549|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1041550|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1041551|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1041552|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1041553|NCT00713830|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1041554|NCT00713830|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
1041555|NCT00713830|E2|Reported Event|Lixisenatide|2-step initiation regimen of lixisenatide.
1041556|NCT00713830|E1|Reported Event|Placebo|2-step initiation regimen of volume matching placebo.
1041557|NCT00713817|B3|Baseline|Total|Total of all reporting groups
1041558|NCT00713817|B2|Baseline|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
1041559|NCT00713817|B1|Baseline|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
1041560|NCT00713817|P2|Participant Flow|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
1041561|NCT00713817|P1|Participant Flow|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
1041562|NCT00713817|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
1041563|NCT00713817|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
1041564|NCT00713817|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
1041565|NCT00713817|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
1041566|NCT00713817|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
1041567|NCT00713817|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
1041568|NCT00713817|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
1041569|NCT00713817|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
1041570|NCT00713817|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
1041571|NCT00713817|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
1041572|NCT00713817|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
1053930|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
1041573|NCT00713817|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
1041574|NCT00713817|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
1041575|NCT00713817|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
1041576|NCT00713817|E2|Reported Event|Placebo|Contains no active drug but colourants and excipients. The maximum permitted dose was 24 actuations in any 24 hour period.
1041577|NCT00713817|E1|Reported Event|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 64.8 mg:CBD 60 mg) in 24 hours.
1041578|NCT00713700|B1|Baseline|Device|AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
1041579|NCT00713700|P1|Participant Flow|Device|AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
1041580|NCT00713700|O1|Outcome|Device|AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
1041581|NCT00713700|O1|Outcome|Device|AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
1041582|NCT00713700|E1|Reported Event|Device|AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
1041583|NCT00713661|B5|Baseline|Total|Total of all reporting groups
1041584|NCT00713661|B4|Baseline|Group 4: Laparoscopic Surgery Middle/Upper|
1041585|NCT00713661|B3|Baseline|Group 3: Laparoscopic Surgery Lower|
1041586|NCT00713661|B2|Baseline|Group 2: Open Surgery Middle/Upper|
1041587|NCT00713661|B1|Baseline|Group 1: Open Surgery Lower|
1041588|NCT00713661|P4|Participant Flow|Group 4: Laparoscopic Surgery Middle/Upper|Laparasocopic colorectal resection. The anastomotic line in the mid/upper segment 5-12 cm from the anal verge.
1041589|NCT00713661|P3|Participant Flow|Group 3: Laparoscopic Surgery Lower|Laparoscopic colorectal resection. The anastomotic line in the low segment approximately 0-5 cm from the anal verge.
1041590|NCT00713661|P2|Participant Flow|Group 2: Open Surgery Middle/Upper|Open colorectal resection. The anastomotic line in the middle/upper segment 5-12 cm from the anal verge.
1041591|NCT00713661|P1|Participant Flow|Group 1: Open Surgery Lower|Open colorectal resection. The anastomotic line in the low segment approximately 0-5 cm from the anal verge.
1041592|NCT00713661|O4|Outcome|Group 4: Laparoscopic Surgery Middle/Upper|
1041593|NCT00713661|O3|Outcome|Group 3: Laparoscopic Surgery Lower|
1041594|NCT00713661|O2|Outcome|Group 2: Open Surgery Middle/Upper|
1041595|NCT00713661|O1|Outcome|Group 1: Open Surgery Lower|
1041596|NCT00713661|O4|Outcome|Group 4: Laparoscopic Surgery Middle/Upper|
1041597|NCT00713661|O3|Outcome|Group 3: Laparoscopic Surgery Lower|
1041598|NCT00713661|O2|Outcome|Group 2: Open Surgery Middle/Upper|
1041599|NCT00713661|O1|Outcome|Group 1: Open Surgery Lower|
1041600|NCT00713661|E4|Reported Event|Group 4: Laparoscopic Surgery Middle/Upper|
1041601|NCT00713661|E3|Reported Event|Group 3: Laparoscopic Surgery Lower|
1041602|NCT00713661|E2|Reported Event|Group 2: Open Surgery Middle/Upper|
1041603|NCT00713661|E1|Reported Event|Group 1: Open Surgery Lower|
1041604|NCT00713648|B1|Baseline|rFXIII|Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings
1041605|NCT00713648|P1|Participant Flow|rFXIII|Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings
1041606|NCT00713648|O1|Outcome|rFXIII|Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings
1041607|NCT00713648|O1|Outcome|rFXIII|Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings
1041608|NCT00713648|O1|Outcome|rFXIII|Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings
1041609|NCT00713648|O1|Outcome|rFXIII|Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings
1041610|NCT00713648|E1|Reported Event|rFXIII|Subjects received 35 IU/kg rFXIII every 4th week (28±2 days) during a treatment period of 52 weeks. In case of acute bleeding episodes, any additional treatment as per investigator judgment was to be according to local standard practice. Additional doses of rFXIII could therefore not be used to treat such breakthrough bleedings
1041611|NCT00713609|B7|Baseline|Total|Total of all reporting groups
1041612|NCT00713609|B6|Baseline|Vehicle Gel + Vehicle Cream|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041744|NCT00713323|O1|Outcome|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
1053931|NCT00684307|O5|Outcome|VKA INR 2-3|
1041613|NCT00713609|B5|Baseline|Vehicle Gel + Tazarotene|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041614|NCT00713609|B4|Baseline|Clindamycin Gel + Tazarotene|Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041615|NCT00713609|B3|Baseline|Benzoyl Peroxide Gel + Tazarotene|Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041616|NCT00713609|B2|Baseline|Benzoyl Peroxide/Clindamycin + Vehicle Cream|Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041617|NCT00713609|B1|Baseline|Benzoyl Peroxide/Clindamycin + Tazarotene|Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face
1041618|NCT00713609|P6|Participant Flow|Vehicle Gel + Vehicle Cream|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041619|NCT00713609|P5|Participant Flow|Vehicle Gel + Tazarotene|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041620|NCT00713609|P4|Participant Flow|Clindamycin Gel + Tazarotene|Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041621|NCT00713609|P3|Participant Flow|Benzoyl Peroxide Gel + Tazarotene|Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041622|NCT00713609|P2|Participant Flow|Benzoyl Peroxide/Clindamycin + Vehicle Cream|Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041623|NCT00713609|P1|Participant Flow|Benzoyl Peroxide/Clindamycin + Tazarotene|Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face
1041624|NCT00713609|O6|Outcome|Vehicle Gel + Vehicle Cream|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041625|NCT00713609|O5|Outcome|Vehicle Gel + Tazarotene|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041626|NCT00713609|O4|Outcome|Clindamycin Gel + Tazarotene|Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041627|NCT00713609|O3|Outcome|Benzoyl Peroxide Gel + Tazarotene|Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041628|NCT00713609|O2|Outcome|Benzoyl Peroxide/Clindamycin + Vehicle Cream|Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041629|NCT00713609|O1|Outcome|Benzoyl Peroxide/Clindamycin + Tazarotene|Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041827|NCT00712920|O1|Outcome|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
1041630|NCT00713609|O6|Outcome|Vehicle Gel + Vehicle Cream|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041631|NCT00713609|O5|Outcome|Vehicle Gel + Tazarotene|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041632|NCT00713609|O4|Outcome|Clindamycin Gel + Tazarotene|Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041633|NCT00713609|O3|Outcome|Benzoyl Peroxide Gel + Tazarotene|Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041634|NCT00713609|O2|Outcome|Benzoyl Peroxide/Clindamycin + Vehicle Cream|Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041635|NCT00713609|O1|Outcome|Benzoyl Peroxide/Clindamycin + Tazarotene|Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041636|NCT00713609|O6|Outcome|Vehicle Gel + Vehicle Cream|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041637|NCT00713609|O5|Outcome|Vehicle Gel + Tazarotene|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041638|NCT00713609|O4|Outcome|Clindamycin Gel + Tazarotene|Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041639|NCT00713609|O3|Outcome|Benzoyl Peroxide Gel + Tazarotene|Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041640|NCT00713609|O2|Outcome|Benzoyl Peroxide/Clindamycin + Vehicle Cream|Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041641|NCT00713609|O1|Outcome|Benzoyl Peroxide/Clindamycin + Tazarotene|Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041642|NCT00713609|O6|Outcome|Vehicle Gel + Vehicle Cream|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041643|NCT00713609|O5|Outcome|Vehicle Gel + Tazarotene|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041644|NCT00713609|O4|Outcome|Clindamycin Gel + Tazarotene|Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041645|NCT00713609|O3|Outcome|Benzoyl Peroxide Gel + Tazarotene|Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041646|NCT00713609|O2|Outcome|Benzoyl Peroxide/Clindamycin + Vehicle Cream|Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1042079|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
1041647|NCT00713609|O1|Outcome|Benzoyl Peroxide/Clindamycin + Tazarotene|Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041648|NCT00713609|E6|Reported Event|Vehicle Gel + Vehicle Cream|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041649|NCT00713609|E5|Reported Event|Vehicle Gel + Tazarotene|Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041650|NCT00713609|E4|Reported Event|Clindamycin Gel + Tazarotene|Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041651|NCT00713609|E3|Reported Event|Benzoyl Peroxide Gel + Tazarotene|Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041652|NCT00713609|E2|Reported Event|Benzoyl Peroxide/Clindamycin + Vehicle Cream|Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041653|NCT00713609|E1|Reported Event|Benzoyl Peroxide/Clindamycin + Tazarotene|Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant’s palm and mixed. A thin film was then applied to the entire face.
1041654|NCT00713596|B4|Baseline|Total|Total of all reporting groups
1041655|NCT00713596|B3|Baseline|Fibrin Sealant Group|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, 0.5 cc to 2 cc of tissue sealant will be applied. Nasal tape will be applied after closure.
1041656|NCT00713596|B2|Baseline|Fibrin Sealant Group, Tape and Cast|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, fibrin sealant will be applied by the surgical assistant to the surgical site. Approximately 0.5 cc to 2 cc of tissue sealant will be applied. After closure, tape and cast will be applied and left in place for one week.
1041657|NCT00713596|B1|Baseline|Control Group|Septorhinoplasty with postoperative application of nasal taping and an external nasal cast. The tape and cast will be left in place for one week. No tissue glue will be used during the operation, although the nurse and surgical assistant will simulate the preparation and insertion of tissue glue using a syringe containing saline.
1041658|NCT00713596|P3|Participant Flow|Fibrin Sealant Group|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, 0.5 cc to 2 cc of tissue sealant will be applied. Nasal tape will be applied after closure.
1041659|NCT00713596|P2|Participant Flow|Fibrin Sealant Group, Tape and Cast|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, fibrin sealant will be applied by the surgical assistant to the surgical site. Approximately 0.5 cc to 2 cc of tissue sealant will be applied. After closure, tape and cast will be applied and left in place for one week.
1041660|NCT00713596|P1|Participant Flow|Control Group|Septorhinoplasty with postoperative application of nasal taping and an external nasal cast. The tape and cast will be left in place for one week. No tissue glue will be used during the operation, although the nurse and surgical assistant will simulate the preparation and insertion of tissue glue using a syringe containing saline.
1041661|NCT00713596|O3|Outcome|Fibrin Sealant Group|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, 0.5 cc to 2 cc of tissue sealant will be applied. Nasal tape will be applied after closure.
1041662|NCT00713596|O2|Outcome|Fibrin Sealant Group, Tape and Cast|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, fibrin sealant will be applied by the surgical assistant to the surgical site. Approximately 0.5 cc to 2 cc of tissue sealant will be applied. After closure, tape and cast will be applied and left in place for one week.
1041663|NCT00713596|O1|Outcome|Control Group|Septorhinoplasty with postoperative application of nasal taping and an external nasal cast. The tape and cast will be left in place for one week. No tissue glue will be used during the operation, although the nurse and surgical assistant will simulate the preparation and insertion of tissue glue using a syringe containing saline.
1041664|NCT00713596|O3|Outcome|Fibrin Sealant Group|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, 0.5 cc to 2 cc of tissue sealant will be applied. Nasal tape will be applied after closure.
1041665|NCT00713596|O2|Outcome|Fibrin Sealant Group, Tape and Cast|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, fibrin sealant will be applied by the surgical assistant to the surgical site. Approximately 0.5 cc to 2 cc of tissue sealant will be applied. After closure, tape and cast will be applied and left in place for one week.
1041666|NCT00713596|O1|Outcome|Control Group|Septorhinoplasty with postoperative application of nasal taping and an external nasal cast. The tape and cast will be left in place for one week. No tissue glue will be used during the operation, although the nurse and surgical assistant will simulate the preparation and insertion of tissue glue using a syringe containing saline.
1041667|NCT00713596|E3|Reported Event|Fibrin Sealant Group|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, 0.5 cc to 2 cc of tissue sealant will be applied. Nasal tape will be applied after closure.
1041668|NCT00713596|E2|Reported Event|Fibrin Sealant Group, Tape and Cast|Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, fibrin sealant will be applied by the surgical assistant to the surgical site. Approximately 0.5 cc to 2 cc of tissue sealant will be applied. After closure, tape and cast will be applied and left in place for one week.
1041669|NCT00713596|E1|Reported Event|Control Group|Septorhinoplasty with postoperative application of nasal taping and an external nasal cast. The tape and cast will be left in place for one week. No tissue glue will be used during the operation, although the nurse and surgical assistant will simulate the preparation and insertion of tissue glue using a syringe containing saline.
1041670|NCT00713544|B7|Baseline|Total|Total of all reporting groups
1041671|NCT00713544|B6|Baseline|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
1041672|NCT00713544|B5|Baseline|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
1041673|NCT00713544|B4|Baseline|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
1041674|NCT00713544|B3|Baseline|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
1041675|NCT00713544|B2|Baseline|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
1041676|NCT00713544|B1|Baseline|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
1041677|NCT00713544|P6|Participant Flow|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
1041678|NCT00713544|P5|Participant Flow|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
1041679|NCT00713544|P4|Participant Flow|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
1041680|NCT00713544|P3|Participant Flow|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
1041681|NCT00713544|P2|Participant Flow|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
1041682|NCT00713544|P1|Participant Flow|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
1041683|NCT00713544|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
1041684|NCT00713544|O5|Outcome|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
1041685|NCT00713544|O4|Outcome|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
1041686|NCT00713544|O3|Outcome|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
1041687|NCT00713544|O2|Outcome|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
1041688|NCT00713544|O1|Outcome|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
1041689|NCT00713544|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
1041690|NCT00713544|O5|Outcome|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
1041691|NCT00713544|O4|Outcome|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
1041692|NCT00713544|O3|Outcome|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
1041693|NCT00713544|O2|Outcome|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
1041694|NCT00713544|O1|Outcome|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
1041695|NCT00713544|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
1041696|NCT00713544|O5|Outcome|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
1041697|NCT00713544|O4|Outcome|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
1041698|NCT00713544|O3|Outcome|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
1041699|NCT00713544|O2|Outcome|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
1041700|NCT00713544|O1|Outcome|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
1041701|NCT00713544|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
1041702|NCT00713544|O5|Outcome|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
1041703|NCT00713544|O4|Outcome|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
1041704|NCT00713544|O3|Outcome|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
1041705|NCT00713544|O2|Outcome|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
1041706|NCT00713544|O1|Outcome|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
1041707|NCT00713544|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
1041708|NCT00713544|O5|Outcome|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
1041709|NCT00713544|O4|Outcome|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
1041710|NCT00713544|O3|Outcome|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
1041711|NCT00713544|O2|Outcome|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
1041712|NCT00713544|O1|Outcome|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
1041713|NCT00713544|E6|Reported Event|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open-label
1041714|NCT00713544|E5|Reported Event|Placebo|Placebo to AZD5672, oral tablets, once daily, double-blinded
1041715|NCT00713544|E4|Reported Event|AZD5672 150 mg|AZD5672 150 mg, oral tablets, once daily, double-blinded
1041716|NCT00713544|E3|Reported Event|AZD5672 100 mg|AZD5672 100 mg, oral tablets, once daily, double-blinded
1041717|NCT00713544|E2|Reported Event|AZD5672 50 mg|AZD5672 50 mg, oral tablets, once daily, double-blinded
1041718|NCT00713544|E1|Reported Event|AZD5672 20 mg|AZD5672 20 mg, oral tablets, once daily, double-blinded
1041719|NCT00713479|B1|Baseline|Total Sample|Includes only subjects who completed both components of the trial.
1041720|NCT00713479|P2|Participant Flow|Varenicline, Then Placebo|Varenicline dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition. After a 14-28 day washout, the placebo condition is started. Placebo is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members).
1041915|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
1041721|NCT00713479|P1|Participant Flow|Placebo, Then Varenicline|Placebo drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition. After a 14-28 day washout, the varenicline condition is started. Varenicline is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members).
1041722|NCT00713479|O2|Outcome|Varenicline|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
1041723|NCT00713479|O1|Outcome|Sugar Pill|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
1041724|NCT00713479|O2|Outcome|Varenicline|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
1041725|NCT00713479|O1|Outcome|Sugar Pill|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
1041726|NCT00713479|O2|Outcome|Varenicline|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
1041727|NCT00713479|O1|Outcome|Sugar Pill|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
1041728|NCT00713479|O2|Outcome|Varenicline|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Varenicline : Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)"
1041729|NCT00713479|O1|Outcome|Sugar Pill|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Sugar pill : Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
1041730|NCT00713479|E2|Reported Event|Varenicline|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Varenicline : Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)"
1041731|NCT00713479|E1|Reported Event|Sugar Pill|"Study drug dosing will begin at 0.5 mg once daily for the first 3 days of condition and will be increased to 0.5 mg twice daily for days 5-6 of this condition, and increased to 1 mg twice daily on days 7-10 of this condition.~Sugar pill : Medication is taken daily for 10 days in the presence of 30 mg IV methamphetamine and 30 mg IV saline (infusion blinded to both study participants and staff members)."
1041732|NCT00713349|B1|Baseline|Vehicle vs. Placebo|"Xenaderm Vehicle and White Petrolatum as Placebo Comparator~Xenaderm Vehicle : Ointment to be applied three times a day on cryo-surgery wound for 21 days.~White Petrolatum : Ointment to be applied three times a day on cryo-surgery wound for 21 days~Each subject acting as their own control"
1041733|NCT00713349|P1|Participant Flow|Vehicle vs. Placebo|"Xenaderm Vehicle and White Petrolatum as Placebo Comparator~Xenaderm Vehicle : Ointment to be applied three times a day on cryo-surgery wound for 21 days.~White Petrolatum : Ointment to be applied three times a day on cryo-surgery wound for 21 days~Each subject acting as their own control"
1041734|NCT00713349|O2|Outcome|Placebo Control|White Petrolatum : each subject acting as their own control
1041735|NCT00713349|O1|Outcome|Vehicle|Xenaderm Ointment Vehicle : each subject acting as their own control
1041736|NCT00713349|E2|Reported Event|Placebo Control|White Petrolatum : each subject acting as their own control
1041737|NCT00713349|E1|Reported Event|Vehicle|Xenaderm Ointment Vehicle : each subject acting as their own control
1041738|NCT00713323|B1|Baseline|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
1041739|NCT00713323|P1|Participant Flow|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
1041740|NCT00713323|O1|Outcome|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
1041741|NCT00713323|O1|Outcome|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
1041742|NCT00713323|O1|Outcome|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
1041743|NCT00713323|O1|Outcome|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
1042080|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
1041745|NCT00713323|O1|Outcome|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
1041746|NCT00713323|O1|Outcome|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
1041747|NCT00713323|O1|Outcome|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
1041748|NCT00713323|E1|Reported Event|Sativex|Subjects received Sativex delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations in 24 hours (THC 65 mg:CBD 60 mg).
1041749|NCT00713310|B3|Baseline|Total|Total of all reporting groups
1041750|NCT00713310|B2|Baseline|High-Dose|17-<33kg: AM 3 Asacol 400mg, PM 2 Asacol 400mg; 33-<54kg: AM5 Asacol 400mg, PM 4 Asacol 400mg; 54-<90kg: AM & PM 6 Asacol 400mg
1041751|NCT00713310|B1|Baseline|Low-Dose|17-<33kg: AM - 2 Asacol 400mg & 1 placebo, PM - 1 Asacol 400mg & 1 placebo; 33-<54kg: AM - 3 Asacol 400mg & 2 placebo, PM - 2 Asacol 400mg & 2 placebo; 54-<90kg: AM & PM - 3 Asacol 400mg & 3 placebo
1041752|NCT00713310|P2|Participant Flow|High-Dose|17-<33kg: AM 3 Asacol 400mg, PM 2 Asacol 400mg; 33-<54kg: AM5 Asacol 400mg, PM 4 Asacol 400mg; 54-<90kg: AM & PM 6 Asacol 400mg
1041753|NCT00713310|P1|Participant Flow|Low-Dose|17-<33kg: AM - 2 Asacol 400mg & 1 placebo, PM - 1 Asacol 400mg & 1 placebo; 33-<54kg: AM - 3 Asacol 400mg & 2 placebo, PM - 2 Asacol 400mg & 2 placebo; 54-<90kg: AM & PM - 3 Asacol 400mg & 3 placebo
1041754|NCT00713310|O2|Outcome|High Dose|High Dose = Asacol 2.0 - 4.8 g/day based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
1041755|NCT00713310|O1|Outcome|Low Dose|Low Dose = Asacol 1.2 - 2.4 g/day stratified based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
1041756|NCT00713310|O2|Outcome|High Dose|High Dose = Asacol 2.0 - 4.8 g/day based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
1041757|NCT00713310|O1|Outcome|Low Dose|Low Dose = Asacol 1.2 - 2.4 g/day stratified based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
1041758|NCT00713310|E2|Reported Event|High Dose|High Dose = Asacol 2.0 - 4.8 g/day based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
1041759|NCT00713310|E1|Reported Event|Low Dose|Low Dose = Asacol 1.2 - 2.4 g/day stratified based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
1041760|NCT00713258|B3|Baseline|Total|Total of all reporting groups
1041761|NCT00713258|B2|Baseline|Alendronate|"PTH (1-84) placebo + alendronate~PTH (1-84) placebo: powder and solvent for solution for injection~alendronate: capsule"
1041762|NCT00713258|B1|Baseline|PTH (1-84)|"PTH (1-84) + placebo alendronate~PTH (1-84): powder and solvent for solution for injection~placebo alendronate: capsule"
1041763|NCT00713258|P2|Participant Flow|Alendronate|"PTH (1-84) placebo + alendronate~PTH (1-84) placebo: powder and solvent for solution for injection~alendronate: capsule"
1041764|NCT00713258|P1|Participant Flow|PTH (1-84)|"PTH (1-84) + placebo alendronate~PTH (1-84): powder and solvent for solution for injection~placebo alendronate: capsule"
1041765|NCT00713258|O2|Outcome|Alendronate|"PTH (1-84) placebo + alendronate~PTH (1-84) placebo: powder and solvent for solution for injection~alendronate: capsule"
1041766|NCT00713258|O1|Outcome|PTH (1-84)|"PTH (1-84) + placebo alendronate~PTH (1-84): powder and solvent for solution for injection~placebo alendronate: capsule"
1041767|NCT00713258|O2|Outcome|Alendronate|"PTH (1-84) placebo + alendronate~PTH (1-84) placebo: powder and solvent for solution for injection~alendronate: capsule"
1041768|NCT00713258|O1|Outcome|PTH (1-84)|"PTH (1-84) + placebo alendronate~PTH (1-84): powder and solvent for solution for injection~placebo alendronate: capsule"
1041769|NCT00713258|E2|Reported Event|Alendronate|"PTH (1-84) placebo + alendronate~PTH (1-84) placebo: powder and solvent for solution for injection~alendronate: capsule"
1041770|NCT00713258|E1|Reported Event|PTH (1-84)|"PTH (1-84) + placebo alendronate~PTH (1-84): powder and solvent for solution for injection~placebo alendronate: capsule"
1041771|NCT00713219|B1|Baseline|Docetaxel + Cetuximab + Concurrent Re-Irradiation|Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity - Modulated Radiation Therapy, IMRT) for Patients with Locoregionally Recurrent Head and Neck Cancer
1041772|NCT00713219|P1|Participant Flow|Docetaxel + Cetuximab + Concurrent Re-Irradiation|Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity - Modulated Radiation Therapy, IMRT) for Patients with Locoregionally Recurrent Head and Neck Cancer
1041773|NCT00713219|O1|Outcome|Docetaxel + Cetuximab + Concurrent Re-Irradiation|Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity - Modulated Radiation Therapy, IMRT) for Patients with Locoregionally Recurrent Head and Neck Cancer
1041774|NCT00713219|E1|Reported Event|Docetaxel + Cetuximab + Concurrent Re-Irradiation|Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity - Modulated Radiation Therapy, IMRT) for Patients with Locoregionally Recurrent Head and Neck Cancer
1041775|NCT00713206|B3|Baseline|Total|Total of all reporting groups
1041776|NCT00713206|B2|Baseline|Control Group|Dental implants placed into graft augmentation material that has four months to heal.
1041777|NCT00713206|B1|Baseline|Treatment Group|Dental implants placed simultaneously with graft augmentation material.
1041778|NCT00713206|P2|Participant Flow|Control Group|Dental implants placed into graft augmentation material that has four months to heal.
1041779|NCT00713206|P1|Participant Flow|Treatment Group|Dental implants placed simultaneously with graft augmentation material.
1041780|NCT00713206|O2|Outcome|Control Group|Dental implants placed into graft augmentation material that has four months to heal.
1041781|NCT00713206|O1|Outcome|Treatment Group|Dental implants placed simultaneously with graft augmentation material.
1041782|NCT00713206|E2|Reported Event|Control Group|Dental implants placed into graft augmentation material that has four months to heal.
1041783|NCT00713206|E1|Reported Event|Treatment Group|Dental implants placed simultaneously with graft augmentation material.
1041784|NCT00712985|B1|Baseline|Zoledronic Acid 5 mg IV|Zometa (Zoledronic Acid) 5 mg IV given over 15 minutes as a one time dose. Follow-up at month 1 & every 2 months to month 12 for serum & urine markers of bone destruction (NTx & CTx).
1041828|NCT00712920|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
1041785|NCT00712985|P1|Participant Flow|Zoledronic Acid 5 mg IV|Zometa (Zoledronic Acid) 5 mg IV given over 15 minutes as a one time dose. Follow-up at month 1 & every 2 months to month 12 for serum & urine markers of bone destruction (NTx & CTx).
1041786|NCT00712985|O1|Outcome|Zoledronic Acid 5 mg IV|Zometa (Zoledronic Acid) 5 mg IV given over 15 minutes as a one time dose. Follow-up at month 1 & every 2 months to month 12 for serum & urine markers of bone destruction (NTx & CTx).
1041787|NCT00712985|E1|Reported Event|Zoledronic Acid 5 mg IV|Zometa (Zoledronic Acid) 5 mg IV given over 15 minutes as a one time dose. Follow-up at month 1 & every 2 months to month 12 for serum & urine markers of bone destruction (NTx & CTx).
1041788|NCT00712959|B3|Baseline|Total|Total of all reporting groups
1041789|NCT00712959|B2|Baseline|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
1041790|NCT00712959|B1|Baseline|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
1041791|NCT00712959|P2|Participant Flow|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
1041792|NCT00712959|P1|Participant Flow|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-Inactivated Poliomyelitis Vaccine (IPV) in a previous study (TD9707 or TD9805)
1041793|NCT00712959|O2|Outcome|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
1041794|NCT00712959|O1|Outcome|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
1041795|NCT00712959|O2|Outcome|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
1041796|NCT00712959|O1|Outcome|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
1041797|NCT00712959|O2|Outcome|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
1041798|NCT00712959|O1|Outcome|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
1041799|NCT00712959|O2|Outcome|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
1041800|NCT00712959|O1|Outcome|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
1041801|NCT00712959|O2|Outcome|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
1041802|NCT00712959|O1|Outcome|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
1041803|NCT00712959|O2|Outcome|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
1041804|NCT00712959|O1|Outcome|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
1041805|NCT00712959|O2|Outcome|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
1041806|NCT00712959|O1|Outcome|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
1041807|NCT00712959|E2|Reported Event|Group 2: Tdap Vaccine-naïve|Age-balanced Tdap vaccine-naïve participants who received Tdap vaccine in the study at least 10 years after a previous tetanus, diphtheria and/or pertussis dose.
1041808|NCT00712959|E1|Reported Event|Group 1: Previous Tdap or Tdap-IPV Recipients|Participants received Tdap or Tdap-IPV in a previous study (TD9707 or TD9805)
1041809|NCT00712920|B4|Baseline|Total|Total of all reporting groups
1041810|NCT00712920|B3|Baseline|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
1041811|NCT00712920|B2|Baseline|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
1041812|NCT00712920|B1|Baseline|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
1041813|NCT00712920|P3|Participant Flow|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
1041814|NCT00712920|P2|Participant Flow|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
1041815|NCT00712920|P1|Participant Flow|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
1041816|NCT00712920|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
1041817|NCT00712920|O2|Outcome|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
1041818|NCT00712920|O1|Outcome|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
1041819|NCT00712920|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
1041820|NCT00712920|O2|Outcome|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
1041821|NCT00712920|O1|Outcome|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
1041822|NCT00712920|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
1041823|NCT00712920|O2|Outcome|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
1041824|NCT00712920|O1|Outcome|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
1041825|NCT00712920|O3|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
1041826|NCT00712920|O2|Outcome|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
1041829|NCT00712920|O2|Outcome|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
1041830|NCT00712920|O1|Outcome|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
1041831|NCT00712920|E3|Reported Event|Astepro 0.15%|0.15% azelastine hydrochloride 1644 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
1041832|NCT00712920|E2|Reported Event|Astepro 0.1%|0.10% azelastine hydrochloride 1096 mcg nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
1041833|NCT00712920|E1|Reported Event|Placebo|Placebo nasal Spray/2 sprays per nostril 2 times a day for 4 weeks
1041834|NCT00712725|B9|Baseline|Total|Total of all reporting groups
1041835|NCT00712725|B8|Baseline|MK3207 200 mg|"MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.~The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
1041836|NCT00712725|B7|Baseline|MK3207 100 mg|"MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.~The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
1041837|NCT00712725|B6|Baseline|MK3207 50 mg|"MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.~The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
1041838|NCT00712725|B5|Baseline|MK3207 20 mg|"MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.~The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
1041839|NCT00712725|B4|Baseline|MK3207 10 mg|"MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.~The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
1041840|NCT00712725|B3|Baseline|MK3207 5 mg|"MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.~The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
1041841|NCT00712725|B2|Baseline|MK3207 2.5 mg|"MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.~The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
1041842|NCT00712725|B1|Baseline|Placebo|"Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.~The participants reported in the Baseline Characteristics are randomized participants that received study treatment."
1041843|NCT00712725|P8|Participant Flow|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041844|NCT00712725|P7|Participant Flow|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041845|NCT00712725|P6|Participant Flow|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041846|NCT00712725|P5|Participant Flow|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041847|NCT00712725|P4|Participant Flow|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041848|NCT00712725|P3|Participant Flow|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041849|NCT00712725|P2|Participant Flow|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041850|NCT00712725|P1|Participant Flow|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041851|NCT00712725|O8|Outcome|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041852|NCT00712725|O7|Outcome|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041853|NCT00712725|O6|Outcome|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041854|NCT00712725|O5|Outcome|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041855|NCT00712725|O4|Outcome|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041856|NCT00712725|O3|Outcome|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041857|NCT00712725|O2|Outcome|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041858|NCT00712725|O1|Outcome|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041859|NCT00712725|O8|Outcome|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041860|NCT00712725|O7|Outcome|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041861|NCT00712725|O6|Outcome|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041862|NCT00712725|O5|Outcome|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041863|NCT00712725|O4|Outcome|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041864|NCT00712725|O3|Outcome|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041865|NCT00712725|O2|Outcome|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041866|NCT00712725|O1|Outcome|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041867|NCT00712725|O8|Outcome|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041868|NCT00712725|O7|Outcome|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041869|NCT00712725|O6|Outcome|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041870|NCT00712725|O5|Outcome|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041871|NCT00712725|O4|Outcome|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041872|NCT00712725|O3|Outcome|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041873|NCT00712725|O2|Outcome|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041874|NCT00712725|O1|Outcome|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041875|NCT00712725|O8|Outcome|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041876|NCT00712725|O7|Outcome|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041877|NCT00712725|O6|Outcome|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041878|NCT00712725|O5|Outcome|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041879|NCT00712725|O4|Outcome|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041880|NCT00712725|O3|Outcome|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041881|NCT00712725|O2|Outcome|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041882|NCT00712725|O1|Outcome|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041883|NCT00712725|O8|Outcome|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041884|NCT00712725|O7|Outcome|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041885|NCT00712725|O6|Outcome|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041886|NCT00712725|O5|Outcome|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041887|NCT00712725|O4|Outcome|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041888|NCT00712725|O3|Outcome|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041889|NCT00712725|O2|Outcome|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041890|NCT00712725|O1|Outcome|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041891|NCT00712725|O8|Outcome|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041892|NCT00712725|O7|Outcome|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041893|NCT00712725|O6|Outcome|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041894|NCT00712725|O5|Outcome|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041895|NCT00712725|O4|Outcome|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041896|NCT00712725|O3|Outcome|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041897|NCT00712725|O2|Outcome|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041898|NCT00712725|O1|Outcome|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041899|NCT00712725|E8|Reported Event|MK3207 200 mg|MK3207 200 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041900|NCT00712725|E7|Reported Event|MK3207 100 mg|MK3207 100 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041901|NCT00712725|E6|Reported Event|MK3207 50 mg|MK3207 50 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041902|NCT00712725|E5|Reported Event|MK3207 20 mg|MK3207 20 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041903|NCT00712725|E4|Reported Event|MK3207 10 mg|MK3207 10 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041904|NCT00712725|E3|Reported Event|MK3207 5 mg|MK3207 5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041905|NCT00712725|E2|Reported Event|MK3207 2.5 mg|MK3207 2.5 mg; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041906|NCT00712725|E1|Reported Event|Placebo|Placebo; one orally administered dose to treat a single moderate-to-severe migraine headache.
1041907|NCT00712673|B4|Baseline|Total|Total of all reporting groups
1041908|NCT00712673|B3|Baseline|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
1041909|NCT00712673|B2|Baseline|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
1041910|NCT00712673|B1|Baseline|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
1041911|NCT00712673|P4|Participant Flow|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
1041912|NCT00712673|P3|Participant Flow|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
1041913|NCT00712673|P2|Participant Flow|Placebo (Evening Injection)|2-step initiation evening regimen of volume matching placebo: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
1041914|NCT00712673|P1|Participant Flow|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
1041916|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
1041917|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
1041918|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
1041919|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
1041920|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
1041921|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
1041922|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
1041923|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
1041924|NCT00712673|O6|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation, morning and evening regimen of lixisenatide.
1041925|NCT00712673|O5|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
1041926|NCT00712673|O4|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
1041927|NCT00712673|O3|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation, morning and evening regimen of volume matching placebo.
1041928|NCT00712673|O2|Outcome|Placebo (Evening Injection)|2-step initiation evening regimen of volume matching placebo.
1041929|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo.
1041930|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
1041931|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
1041932|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation, morning and evening regimen of volume matching placebo.
1041933|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
1041934|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
1041935|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
1041936|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
1041937|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
1041938|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
1041939|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
1041940|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
1041941|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
1041942|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
1041943|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
1041944|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
1041945|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
1041946|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
1041947|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
1041948|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
1041949|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
1041950|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
1041951|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
1041952|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
1041953|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
1041954|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
1041955|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
1041956|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
1041957|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
1041958|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
1041959|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
1041960|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
1041961|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
1041962|NCT00712673|O1|Outcome|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo to lixisenatide.
1041963|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
1041964|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
1041965|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
1041966|NCT00712673|O3|Outcome|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
1041967|NCT00712673|O2|Outcome|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
1042081|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
1041968|NCT00712673|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
1041969|NCT00712673|E6|Reported Event|Lixisenatide (Combined)|Included all patients who received 2-step initiation morning and evening regimen of lixisenatide.
1041970|NCT00712673|E5|Reported Event|Lixisenatide (Evening Injection)|2-step initiation evening regimen of lixisenatide.
1041971|NCT00712673|E4|Reported Event|Lixisenatide (Morning Injection)|2-step initiation morning regimen of lixisenatide.
1041972|NCT00712673|E3|Reported Event|Placebo (Combined)|Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.
1041973|NCT00712673|E2|Reported Event|Placebo (Evening Injection)|2-step initiation evening regimen of volume matching placebo.
1041974|NCT00712673|E1|Reported Event|Placebo (Morning Injection)|2-step initiation morning regimen of volume matching placebo.
1041975|NCT00712543|B3|Baseline|Total|Total of all reporting groups
1041976|NCT00712543|B2|Baseline|Liquid, Then Powder Lactulose|Liquid lactulose, as perscribed, for the first 7 days, then Kristalose (powder lactulose), as perscribed, for the second 7 days.
1041977|NCT00712543|B1|Baseline|Powder, Then Liquid Lactulose|Kristalose (powder lactulose), as perscribed, for the first 7 days, then liquid lactulose (as perscribed) for the second 7 days.
1041978|NCT00712543|P2|Participant Flow|Liquid, Then Powder Lactulose|Liquid lactulose, as perscribed, for the first 7 days, then Kristalose (powder lactulose), as perscribed, for the second 7 days.
1041979|NCT00712543|P1|Participant Flow|Powder, Then Liquid Lactulose|Kristalose (powder lactulose), as perscribed, for the first 7 days, then liquid lactulose (as perscribed) for the second 7 days.
1041980|NCT00712543|O2|Outcome|Liquid, Then Powder Lactulose|Liquid lactulose, as perscribed, for the first 7 days, then Kristalose (powder lactulose), as perscribed, for the second 7 days.
1041981|NCT00712543|O1|Outcome|Powder, Then Liquid Lactulose|Kristalose (powder lactulose), as perscribed, for the first 7 days, then liquid lactulose (as perscribed) for the second 7 days.
1041982|NCT00712543|E2|Reported Event|Liquid, Then Powder Lactulose|Liquid lactulose, as perscribed, for the first 7 days, then Kristalose (powder lactulose), as perscribed, for the second 7 days.
1041983|NCT00712543|E1|Reported Event|Powder, Then Liquid Lactulose|Kristalose (powder lactulose), as perscribed, for the first 7 days, then liquid lactulose (as perscribed) for the second 7 days.
1041984|NCT00712530|B4|Baseline|Total|Total of all reporting groups
1041985|NCT00712530|B3|Baseline|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization~0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir~Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
1041986|NCT00712530|B2|Baseline|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization~0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir~Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
1041987|NCT00712530|B1|Baseline|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization~0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir~Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
1041988|NCT00712530|P3|Participant Flow|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization~0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir~Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
1041989|NCT00712530|P2|Participant Flow|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization~0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir~Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
1041990|NCT00712530|P1|Participant Flow|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization~0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir~Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
1041991|NCT00712530|O3|Outcome|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization~0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir~Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
1041992|NCT00712530|O2|Outcome|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization~0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir~Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
1041993|NCT00712530|O1|Outcome|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization~0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir~Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
1041994|NCT00712530|O3|Outcome|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization~0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir~Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
1041995|NCT00712530|O2|Outcome|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization~0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir~Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
1041996|NCT00712530|O1|Outcome|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization~0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir~Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
1041997|NCT00712530|O3|Outcome|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization~0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir~Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
1041998|NCT00712530|O2|Outcome|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization~0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir~Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
1041999|NCT00712530|O1|Outcome|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization~0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir~Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
1042000|NCT00712530|O3|Outcome|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization~0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir~Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
1042036|NCT00712335|O4|Outcome|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
1042001|NCT00712530|O2|Outcome|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization~0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir~Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
1042002|NCT00712530|O1|Outcome|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization~0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir~Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
1042003|NCT00712530|O3|Outcome|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization~0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir~Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
1042004|NCT00712530|O2|Outcome|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization~0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir~Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
1042005|NCT00712530|O1|Outcome|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization~0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir~Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
1042006|NCT00712530|O3|Outcome|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization~0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir~Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
1042007|NCT00712530|O2|Outcome|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization~0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir~Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
1042008|NCT00712530|O1|Outcome|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization~0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir~Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
1042009|NCT00712530|E3|Reported Event|Single High-dose (0.8 mg pDNA/Subject) DermaVir Immunization|"Single high-dose DermaVir immunization~0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir~Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)"
1042010|NCT00712530|E2|Reported Event|Single Medium-dose (0.4 mg pDNA/Subject) DermaVir Immunization|"Single medium-dose DermaVir immunization~0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir~Administered topically with DermaPrep under four skin patches (0.8 mL/patch)"
1042011|NCT00712530|E1|Reported Event|Single Low-dose (0.1 mg pDNA/Subject) DermaVir Immunization|"Single low-dose DermaVir immunization~0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir~Administered topically with DermaPrep under two skin patches (0.4 mL/patch)"
1042012|NCT00712348|B1|Baseline|Taliglucerase Alfa|"Open label taliglucerase alfa treatment~Taliglucerase alfa: Intravenous infusion every 2 weeks"
1042013|NCT00712348|P1|Participant Flow|Taliglucerase Alfa|"Open label taliglucerase alfa treatment~Taliglucerase alfa: Intravenous infusion every 2 weeks"
1042014|NCT00712348|O1|Outcome|Taliglucerase Alfa|"Open label taliglucerase alfa treatment~Taliglucerase alfa: Intravenous infusion every 2 weeks"
1042015|NCT00712348|O1|Outcome|Taliglucerase Alfa|"Open label taliglucerase alfa treatment~Taliglucerase alfa: Intravenous infusion every 2 weeks"
1042016|NCT00712348|O1|Outcome|Taliglucerase Alfa|"Open label taliglucerase alfa treatment~Taliglucerase alfa: Intravenous infusion every 2 weeks"
1042017|NCT00712348|O1|Outcome|Taliglucerase Alfa|"Open label taliglucerase alfa treatment~Taliglucerase alfa: Intravenous infusion every 2 weeks"
1042018|NCT00712348|E1|Reported Event|Taliglucerase Alfa|"Open label taliglucerase alfa treatment~Taliglucerase alfa: Intravenous infusion every 2 weeks"
1042019|NCT00712335|B6|Baseline|Total|Total of all reporting groups
1042020|NCT00712335|B5|Baseline|Normal Controls|Normal controls did not receive any treatment.
1042021|NCT00712335|B4|Baseline|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
1042022|NCT00712335|B3|Baseline|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
1042023|NCT00712335|B2|Baseline|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
1042024|NCT00712335|B1|Baseline|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
1042025|NCT00712335|P5|Participant Flow|Normal Controls|Normal controls did not receive any treatment.
1042026|NCT00712335|P4|Participant Flow|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
1042027|NCT00712335|P3|Participant Flow|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
1042028|NCT00712335|P2|Participant Flow|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
1042029|NCT00712335|P1|Participant Flow|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
1042030|NCT00712335|O5|Outcome|Normal Controls|Normal controls did not receive any treatment.
1042031|NCT00712335|O4|Outcome|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
1042032|NCT00712335|O3|Outcome|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
1042033|NCT00712335|O2|Outcome|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
1042034|NCT00712335|O1|Outcome|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
1042035|NCT00712335|O5|Outcome|Normal Controls|Normal controls did not receive any treatment.
1053932|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
1042037|NCT00712335|O3|Outcome|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
1042038|NCT00712335|O2|Outcome|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
1042039|NCT00712335|O1|Outcome|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
1042040|NCT00712335|O5|Outcome|Normal Controls|Normal controls did not receive any treatment.
1042041|NCT00712335|O4|Outcome|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
1042042|NCT00712335|O3|Outcome|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
1042043|NCT00712335|O2|Outcome|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
1042044|NCT00712335|O1|Outcome|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
1042045|NCT00712335|O5|Outcome|Normal Controls|Normal controls did not receive any treatment.
1042046|NCT00712335|O4|Outcome|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
1042047|NCT00712335|O3|Outcome|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
1042048|NCT00712335|O2|Outcome|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
1042049|NCT00712335|O1|Outcome|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
1042050|NCT00712335|O5|Outcome|Normal Controls|Normal controls did not receive any treatment.
1042051|NCT00712335|O4|Outcome|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
1042052|NCT00712335|O3|Outcome|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
1042053|NCT00712335|O2|Outcome|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
1042054|NCT00712335|O1|Outcome|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
1042055|NCT00712335|O5|Outcome|Normal Controls|Normal controls did not receive any treatment.
1042056|NCT00712335|O4|Outcome|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
1042057|NCT00712335|O3|Outcome|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
1042058|NCT00712335|O2|Outcome|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
1042059|NCT00712335|O1|Outcome|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
1042060|NCT00712335|O5|Outcome|Normal Controls|Normal controls did not receive any treatment.
1042061|NCT00712335|O4|Outcome|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
1042062|NCT00712335|O3|Outcome|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
1042063|NCT00712335|O2|Outcome|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
1042064|NCT00712335|O1|Outcome|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
1042065|NCT00712335|E5|Reported Event|Normal Controls|Normal controls did not receive any treatment.
1042066|NCT00712335|E4|Reported Event|Non-smoking Asthmatic Treated With Montelukast Only|"Non-smoking asthmatic treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
1042067|NCT00712335|E3|Reported Event|Non-smoking Asthmatic Treated With Combination Therapy|"Non-smoking asthmatic treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
1042068|NCT00712335|E2|Reported Event|Asthmatic Smoker Treated With Montelukast Only|"Asthmatic smoker treated with Montelukast only:~Montelukast dosage - PO 10 mg QHS for 3 months"
1042069|NCT00712335|E1|Reported Event|Asthmatic Smokers Treated With Combination Therapy|"Asthmatic smokers treated with combination therapy:~Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months"
1042070|NCT00712244|B5|Baseline|Total|Total of all reporting groups
1042071|NCT00712244|B4|Baseline|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
1042072|NCT00712244|B3|Baseline|Healon5|Healon5 Ophthalmic Viscosurgical Device
1042073|NCT00712244|B2|Baseline|DUOVISC|DUOVISC® Viscoelastic system
1042074|NCT00712244|B1|Baseline|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
1042075|NCT00712244|P4|Participant Flow|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
1042076|NCT00712244|P3|Participant Flow|Healon5|Healon5 Ophthalmic Viscosurgical Device
1042083|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
1042084|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
1042085|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
1042086|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
1042087|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
1042088|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
1042089|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
1042090|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
1042091|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
1042092|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
1042093|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
1042094|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
1042095|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
1042096|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
1042097|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
1042098|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
1042099|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
1042100|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
1042101|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
1042102|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
1042103|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
1042104|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
1042105|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
1042106|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
1042107|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
1042108|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
1042109|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
1042110|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
1042111|NCT00712244|O4|Outcome|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
1042112|NCT00712244|O3|Outcome|Healon5|Healon5 Ophthalmic Viscosurgical Device
1042113|NCT00712244|O2|Outcome|DUOVISC|DUOVISC® Viscoelastic system
1042114|NCT00712244|O1|Outcome|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
1042115|NCT00712244|E4|Reported Event|Amvisc Plus|Amvisc Plus Ophthalmic Viscosurgical Device
1042116|NCT00712244|E3|Reported Event|Healon5|Healon5 Ophthalmic Viscosurgical Device
1042117|NCT00712244|E2|Reported Event|DUOVISC|DUOVISC® Viscoelastic system
1042118|NCT00712244|E1|Reported Event|DISCOVISC|DISCOVISC® Ophthalmic Viscosurgical Device (OVD)
1042119|NCT00712179|B1|Baseline|Stroke Survivors|Cross-sectional study with a single group of stroke survivors
1042120|NCT00712179|P1|Participant Flow|Stroke Survivors|Stroke survivors walked with varying speeds, amount of body weight support or therapist assistance
1042121|NCT00712179|O1|Outcome|Stroke Survivors|Stroke survivors walked with varying speeds, amount of body weight support or therapist assistance
1042122|NCT00712179|E1|Reported Event|Stroke Survivors|Subjects walked with or with therapists' assistance at different speeds and different amounts of body weight support across conditions.
1042123|NCT00712166|B3|Baseline|Total|Total of all reporting groups
1042124|NCT00712166|B2|Baseline|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
1042125|NCT00712166|B1|Baseline|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
1042126|NCT00712166|P2|Participant Flow|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
1042127|NCT00712166|P1|Participant Flow|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
1042128|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
1042129|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
1042130|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
1042131|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
1042132|NCT00712166|O2|Outcome|AZLI 75 mg TID|"AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.~Day 0: number of isolates = 104; Day 28: number of isolates = 76"
1042198|NCT00711997|O1|Outcome|BC-819 4 mg|1 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection for 2 weeks of twice weekly intratumoral BC-819. Intratumoral injections were performed using CT-guided PTA or EUS of BC-819.
1042400|NCT00711594|O1|Outcome|BIBW 20mg|Continuous once daily oral treatment with BIBW 2992 20mg tablets
1042133|NCT00712166|O1|Outcome|Placebo TID|"Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.~Day 0: number of isolates = 104; Day 28: number of isolates = 108"
1042134|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
1042135|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
1042136|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
1042137|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
1042138|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
1042139|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
1042140|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
1042141|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
1042142|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
1042143|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
1042144|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
1042145|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
1042146|NCT00712166|O2|Outcome|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
1042147|NCT00712166|O1|Outcome|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
1042148|NCT00712166|E2|Reported Event|AZLI 75 mg Three Times Daily (TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer.
1042149|NCT00712166|E1|Reported Event|Placebo Three Times Daily (TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer.
1042150|NCT00712075|B4|Baseline|Total|Total of all reporting groups
1042151|NCT00712075|B3|Baseline|PDA-Only|"PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.~PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings."
1042152|NCT00712075|B2|Baseline|CBSST|"Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.~Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis."
1042153|NCT00712075|B1|Baseline|CBSST+PDA|"PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.~CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance."
1042154|NCT00712075|P3|Participant Flow|PDA-Only|"PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.~PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings."
1042155|NCT00712075|P2|Participant Flow|CBSST|"Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.~Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis."
1042156|NCT00712075|P1|Participant Flow|CBSST+PDA|"PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.~CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance."
1042157|NCT00712075|O3|Outcome|PDA-Only|"PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.~PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings."
1042158|NCT00712075|O2|Outcome|CBSST|"Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.~Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis."
1042159|NCT00712075|O1|Outcome|CBSST+PDA|"PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.~CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance."
1042160|NCT00712075|O3|Outcome|PDA-Only|"PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.~PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings."
1042161|NCT00712075|O2|Outcome|CBSST|"Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.~Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis."
1042162|NCT00712075|O1|Outcome|CBSST+PDA|"PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.~CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance."
1042163|NCT00712075|O3|Outcome|PDA-Only|"PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.~PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings."
1042164|NCT00712075|O2|Outcome|CBSST|"Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.~Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis."
1042165|NCT00712075|O1|Outcome|CBSST+PDA|"PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.~CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance."
1042166|NCT00712075|E3|Reported Event|PDA-Only|"PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.~PDA-only: To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings."
1042288|NCT00711867|E2|Reported Event|Bair Hugger Temperature Management|Arizant Bair Hugger temperature management system.
1053933|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
1042167|NCT00712075|E2|Reported Event|CBSST|"Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.~Cognitive Behavioral Social Skills Training: Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis."
1042168|NCT00712075|E1|Reported Event|CBSST+PDA|"PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.~CBSST+PDA: PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance."
1042169|NCT00712010|B1|Baseline|Entire Study Population|Includes groups randomized to receive 7 products in a randomized series
1042170|NCT00712010|P1|Participant Flow|7 Proteins Were Tested Randomly|"Seven high-protein meal replacement (MR) were tested. These high-protein MR contained 29% total energy intake (TEI) of protein, 28% TEI lipids and 43% TEI glucides in 400mL meal, were iso-nitrogenous and differed in their protein quality. The proteins were:~intact whey protein~whey protein micelles~exhaustively hydrolyzed whey protein~intact casein protein~exhaustively hydrolyzed casein protein~total milk protein~exhaustively hydrolyzed milk protein The high-protein MR were a 430g liquid meal containing 30g of the tested protein."
1042171|NCT00712010|O7|Outcome|Hydrolyzed Milk Protein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
1042172|NCT00712010|O6|Outcome|Total Milk Protein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
1042173|NCT00712010|O5|Outcome|Hydrolyzed Casein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
1042174|NCT00712010|O4|Outcome|Casein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
1042175|NCT00712010|O3|Outcome|Hydrolyzed Whey Protein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
1042176|NCT00712010|O2|Outcome|Whey Protein Microgels|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
1042177|NCT00712010|O1|Outcome|Whey Protein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
1042178|NCT00712010|O7|Outcome|Hydrolyzed Milk Protein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
1042179|NCT00712010|O6|Outcome|Total Milk Protein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
1042180|NCT00712010|O5|Outcome|Hydrolyzed Casein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
1042181|NCT00712010|O4|Outcome|Casein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
1042182|NCT00712010|O3|Outcome|Hydrolyzed Whey Protein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
1042183|NCT00712010|O2|Outcome|Whey Protein Microgels|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
1042184|NCT00712010|O1|Outcome|Whey Protein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
1042185|NCT00712010|E7|Reported Event|Hydrolyzed Milk Protein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
1042186|NCT00712010|E6|Reported Event|Total Milk Protein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
1042187|NCT00712010|E5|Reported Event|Hydrolyzed Casein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
1042188|NCT00712010|E4|Reported Event|Casein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
1042189|NCT00712010|E3|Reported Event|Hydrolyzed Whey Protein|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
1042190|NCT00712010|E2|Reported Event|Whey Protein Microgels|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
1042191|NCT00712010|E1|Reported Event|Whey Protein Native|High-protein meal replacement : Acute ingestion of a high-protein meal replacement followed by blood sampling for 180 minutes.
1042192|NCT00711997|B3|Baseline|Total|Total of all reporting groups
1042193|NCT00711997|B2|Baseline|BC-819 8 mg|
1042194|NCT00711997|B1|Baseline|BC-819 4 mg|
1042195|NCT00711997|P2|Participant Flow|BC-819 8 mg|Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 2 mL of 4 mg/mL for a total of 8 mg of BC-819.
1042196|NCT00711997|P1|Participant Flow|BC-819 4 mg|Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 1 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection.
1042197|NCT00711997|O2|Outcome|BC-819 8 mg|2 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection for 2 weeks of twice weekly intratumoral BC-819. Intratumoral injections were performed using CT-guided PTA or EUS of BC-819.
1042289|NCT00711867|E1|Reported Event|VH2 Temperature Management|Dynatherm vitalHeat2 (VH2) temperature management system.
1042199|NCT00711997|O2|Outcome|BC-819 8 mg|Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 2 mL of 4 mg/mL for a total of 8 mg of BC-819.
1042200|NCT00711997|O1|Outcome|BC-819 4 mg|Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 1 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection.
1042201|NCT00711997|O2|Outcome|BC-819 8 mg|Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 2 mL of 4 mg/mL for a total of 8 mg of BC-819.
1042202|NCT00711997|O1|Outcome|BC-819 4 mg|Each cohort of 3 to 6 subjects received 2 weeks of twice weekly intratumoral injections of BC-819. Intratumoral injections were performed using PTA- or EUS-guided administrations of BC-819. For each treatment, this cohort received a single injection of 1 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection.
1042203|NCT00711997|E2|Reported Event|BC-819 8 mg|2 mL of 4 mg/mL for a total of 8 mg of BC-819 per injection for 2 weeks of twice weekly intratumoral BC-819.
1042204|NCT00711997|E1|Reported Event|BC-819 4 mg|1 mL of 4 mg/mL for a total of 4 mg of BC-819 per injection for 2 weeks of twice weekly intratumoral BC-819.
1042205|NCT00711971|B4|Baseline|Total|Total of all reporting groups
1042206|NCT00711971|B3|Baseline|Soy Oil Placebo|placebo: control arm
1042207|NCT00711971|B2|Baseline|DHA-rich Fish Oil Supplement|"DHA-rich fish oil supplement~DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA"
1042208|NCT00711971|B1|Baseline|EPA-rich Fish Oil Supplement|"EPA-rich fish oil supplement~EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA"
1042209|NCT00711971|P3|Participant Flow|Soy Oil Placebo|Soy oil placebo: control arm
1042210|NCT00711971|P2|Participant Flow|DHA-rich Fish Oil Supplement|DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
1042211|NCT00711971|P1|Participant Flow|EPA-rich Fish Oil Supplement|EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
1042212|NCT00711971|O3|Outcome|Soy Oil Placebo|Soy oil placebo: control arm
1042213|NCT00711971|O2|Outcome|DHA-rich Fish Oil Supplement|DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
1042214|NCT00711971|O1|Outcome|EPA-rich Fish Oil Supplement|EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
1042215|NCT00711971|O3|Outcome|Soy Oil Placebo|Soy oil placebo: control arm
1042216|NCT00711971|O2|Outcome|DHA-rich Fish Oil Supplement|DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
1042217|NCT00711971|O1|Outcome|EPA-rich Fish Oil Supplement|EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
1042218|NCT00711971|O3|Outcome|Soy Oil Placebo|Soy oil placebo: control arm
1042219|NCT00711971|O2|Outcome|DHA-rich Fish Oil Supplement|DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
1042220|NCT00711971|O1|Outcome|EPA-rich Fish Oil Supplement|EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
1042221|NCT00711971|O3|Outcome|Soy Oil Placebo|Soy oil placebo: control arm
1042222|NCT00711971|O2|Outcome|DHA-rich Fish Oil Supplement|DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
1042223|NCT00711971|O1|Outcome|EPA-rich Fish Oil Supplement|EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
1042224|NCT00711971|O3|Outcome|Soy Oil Placebo|Soy oil placebo: control arm
1042225|NCT00711971|O2|Outcome|DHA-rich Fish Oil Supplement|DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
1042226|NCT00711971|O1|Outcome|EPA-rich Fish Oil Supplement|EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
1042227|NCT00711971|O3|Outcome|Soy Oil Placebo|Soy oil placebo: control arm
1042228|NCT00711971|O2|Outcome|DHA-rich Fish Oil Supplement|DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
1042229|NCT00711971|O1|Outcome|EPA-rich Fish Oil Supplement|EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
1042230|NCT00711971|O3|Outcome|Soy Oil Placebo|Soy oil placebo: control arm
1042231|NCT00711971|O2|Outcome|DHA-rich Fish Oil Supplement|DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
1042232|NCT00711971|O1|Outcome|EPA-rich Fish Oil Supplement|EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
1042233|NCT00711971|O3|Outcome|Soy Oil Placebo|"Soy oil~placebo: control arm"
1042234|NCT00711971|O2|Outcome|DHA-rich Fish Oil Supplement|"DHA-rich fish oil supplement~DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA"
1042235|NCT00711971|O1|Outcome|EPA-rich Fish Oil Supplement|"EPA-rich fish oil supplement~EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA"
1042236|NCT00711971|O3|Outcome|Soy Oil Placebo|placebo: control arm
1042237|NCT00711971|O2|Outcome|DHA-rich Fish Oil Supplement|"DHA-rich fish oil supplement~DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA"
1042238|NCT00711971|O1|Outcome|EPA-rich Fish Oil Supplement|"EPA-rich fish oil supplement~EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA"
1042239|NCT00711971|E3|Reported Event|Soy Oil Placebo|Soy oil placebo: control arm
1042240|NCT00711971|E2|Reported Event|DHA-rich Fish Oil Supplement|DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
1042241|NCT00711971|E1|Reported Event|EPA-rich Fish Oil Supplement|EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
1042242|NCT00711880|B3|Baseline|Total|Total of all reporting groups
1042243|NCT00711880|B2|Baseline|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
1042244|NCT00711880|B1|Baseline|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
1042245|NCT00711880|P2|Participant Flow|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
1042246|NCT00711880|P1|Participant Flow|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
1042247|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
1053934|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
1042248|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
1042249|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
1042250|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
1042251|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
1042252|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
1042253|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
1042254|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
1042255|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
1042256|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
1042257|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
1042258|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
1042259|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
1042260|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
1042261|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
1042262|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
1042263|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
1042264|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
1042265|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
1042266|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
1042267|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
1042268|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
1042269|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
1042270|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
1042271|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
1042272|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
1042273|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
1042274|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
1042275|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
1042276|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
1042277|NCT00711880|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
1042278|NCT00711880|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
1042279|NCT00711880|E2|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
1042280|NCT00711880|E1|Reported Event|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
1042281|NCT00711867|B3|Baseline|Total|Total of all reporting groups
1042282|NCT00711867|B2|Baseline|Bair Hugger Temperature Management|Arizant Bair Hugger temperature management system.
1042283|NCT00711867|B1|Baseline|VH2 Temperature Management|Dynatherm vitalHeat2 (VH2) temperature management system.
1042284|NCT00711867|P2|Participant Flow|Bair Hugger Temperature Management|Arizant Bair Hugger temperature management system.
1042285|NCT00711867|P1|Participant Flow|VH2 Temperature Management|Dynatherm vitalHeat2 (VH2) temperature management system.
1042286|NCT00711867|O2|Outcome|Bair Hugger Temperature Management|Arizant Bair Hugger temperature management system.
1042287|NCT00711867|O1|Outcome|VH2 Temperature Management|Dynatherm vitalHeat2 (VH2) temperature management system.
1053935|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
1042290|NCT00711828|B1|Baseline|Treatment|Rituximab 375 mg/m2 IV on day 1 > Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22 > Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22 > Dexamethasone 40 mg PO on days 1, 8, 15, 22
1042291|NCT00711828|P1|Participant Flow|Treatment|Rituximab 375 mg/m2 IV on day 1 > Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22 > Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22 > Dexamethasone 40 mg PO on days 1, 8, 15, 22
1042292|NCT00711828|O1|Outcome|Treatment|"Rituximab 375 mg/m2 IV on day 1~> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22~> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22~> Dexamethasone 40 mg PO on days 1, 8, 15, 22"
1042293|NCT00711828|O1|Outcome|Treatment|"Rituximab 375 mg/m2 IV on day 1~> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22~> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22~> Dexamethasone 40 mg PO on days 1, 8, 15, 22"
1042294|NCT00711828|O1|Outcome|Treatment|"Rituximab 375 mg/m2 IV on day 1~> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22~> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22~> Dexamethasone 40 mg PO on days 1, 8, 15, 22"
1042295|NCT00711828|O1|Outcome|Treatment|"Rituximab 375 mg/m2 IV on day 1~> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22~> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22~> Dexamethasone 40 mg PO on days 1, 8, 15, 22"
1042296|NCT00711828|O1|Outcome|Treatment|"Rituximab 375 mg/m2 IV on day 1~> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22~> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22~> Dexamethasone 40 mg PO on days 1, 8, 15, 22"
1042297|NCT00711828|O1|Outcome|Treatment|"Rituximab 375 mg/m2 IV on day 1~> Cyclophosphamide 300 mg/m2 PO on days 1, 8, 15, 22~> Bortezomib 1.3 mg/m2 IV on days 1, 8, 15, 22~> Dexamethasone 40 mg PO on days 1, 8, 15, 22"
1042298|NCT00711828|E1|Reported Event|Treatment|Dexamethasone 40 mg PO on days 1, 8, 15, 22
1042299|NCT00711802|B9|Baseline|Total|Total of all reporting groups
1042300|NCT00711802|B8|Baseline|Age Group 4: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 4: Participants ages 1 to <2 years"
1042301|NCT00711802|B7|Baseline|Age Group 4: Daptomycin|"Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days~Age Group 4: Participants ages 1 to <2 years"
1042302|NCT00711802|B6|Baseline|Age Group 3: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 3: Participants ages 2 to 6 years"
1042303|NCT00711802|B5|Baseline|Age Group 3: Daptomycin|"Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days~Age Group 3: Participants ages 2 to 6 years"
1042304|NCT00711802|B4|Baseline|Age Group 2: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 2: Participants ages 7 to 11 years"
1042305|NCT00711802|B3|Baseline|Age Group 2: Daptomycin|"Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days~Age Group 2: Participants ages 7 to 11 years"
1042306|NCT00711802|B2|Baseline|Age Group 1: Standard of Care (SOC)|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 1: Participants ages 12 to 17 years"
1042307|NCT00711802|B1|Baseline|Age Group 1: Daptomycin|"Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days~Age Group 1: Participants ages 12 to 17 years"
1042308|NCT00711802|P8|Participant Flow|Age Group 4: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 4: Participants ages 1 to <2 years"
1042309|NCT00711802|P7|Participant Flow|Age Group 4: Daptomycin|"Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days~Age Group 4: Participants ages 1 to <2 years"
1042310|NCT00711802|P6|Participant Flow|Age Group 3: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 3: Participants ages 2 to 6 years"
1042311|NCT00711802|P5|Participant Flow|Age Group 3: Daptomycin|"Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days~Age Group 3: Participants ages 2 to 6 years"
1042312|NCT00711802|P4|Participant Flow|Age Group 2: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 2: Participants ages 7 to 11 years"
1042313|NCT00711802|P3|Participant Flow|Age Group 2: Daptomycin|"Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days~Age Group 2: Participants ages 7 to 11 years"
1042314|NCT00711802|P2|Participant Flow|Age Group 1: Standard of Care (SOC)|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 1: Participants ages 12 to 17 years"
1042315|NCT00711802|P1|Participant Flow|Age Group 1: Daptomycin|"Daptomycin: 5 milligrams/kilogram (mg/kg) administered intravenously (IV) every 24 hours for up to 14 days~Age Group 1: Participants ages 12 to 17 years"
1042316|NCT00711802|O4|Outcome|Age Group 4: Daptomycin|"Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days~Age Group 4: Participants ages 1 to <2 years"
1042317|NCT00711802|O3|Outcome|Age Group 3: Daptomycin|"Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days~Age Group 3: Participants ages 2 to 6 years"
1042318|NCT00711802|O2|Outcome|Age Group 2: Daptomycin|"Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days~Age Group 2: Participants ages 7 to 11 years"
1042319|NCT00711802|O1|Outcome|Age Group 1: Daptomycin|"Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days~Age Group 1: Participants ages 12 to 17 years"
1042320|NCT00711802|O8|Outcome|Age Group 4: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 4: Participants ages 1 to <2 years"
1053936|NCT00684307|O5|Outcome|VKA INR 2-3|
1042321|NCT00711802|O7|Outcome|Age Group 4: Daptomycin|"Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days~Age Group 4: Participants ages 1 to <2 years"
1042322|NCT00711802|O6|Outcome|Age Group 3: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 3: Participants ages 2 to 6 years"
1042323|NCT00711802|O5|Outcome|Age Group 3: Daptomycin|"Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days~Age Group 3: Participants ages 2 to 6 years"
1042324|NCT00711802|O4|Outcome|Age Group 2: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 2: Participants ages 7 to 11 years"
1042325|NCT00711802|O3|Outcome|Age Group 2: Daptomycin|"Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days~Age Group 2: Participants ages 7 to 11 years"
1042326|NCT00711802|O2|Outcome|Age Group 1: Standard of Care (SOC)|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 1: Participants ages 12 to 17 years"
1042327|NCT00711802|O1|Outcome|Age Group 1: Daptomycin|"Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days~Age Group 1: Participants ages 12 to 17 years"
1042328|NCT00711802|O8|Outcome|Age Group 4: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 4: Participants ages 1 to <2 years"
1042329|NCT00711802|O7|Outcome|Age Group 4: Daptomycin|"Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days~Age Group 4: Participants ages 1 to <2 years"
1042330|NCT00711802|O6|Outcome|Age Group 3: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 3: Participants ages 2 to 6 years"
1042331|NCT00711802|O5|Outcome|Age Group 3: Daptomycin|"Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days~Age Group 3: Participants ages 2 to 6 years"
1042332|NCT00711802|O4|Outcome|Age Group 2: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 2: Participants ages 7 to 11 years"
1042333|NCT00711802|O3|Outcome|Age Group 2: Daptomycin|"Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days~Age Group 2: Participants ages 7 to 11 years"
1042334|NCT00711802|O2|Outcome|Age Group 1: Standard of Care (SOC)|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 1: Participants ages 12 to 17 years"
1042335|NCT00711802|O1|Outcome|Age Group 1: Daptomycin|"Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days~Age Group 1: Participants ages 12 to 17 years"
1042336|NCT00711802|E8|Reported Event|Age Group 4: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 4: Participants ages 1 to <2 years"
1042337|NCT00711802|E7|Reported Event|Age Group 4: Daptomycin|"Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days~Age Group 4: Participants ages 1 to <2 years"
1042338|NCT00711802|E6|Reported Event|Age Group 3: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 3: Participants ages 2 to 6 years"
1042339|NCT00711802|E5|Reported Event|Age Group 3: Daptomycin|"Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days~Age Group 3: Participants ages 2 to 6 years"
1042340|NCT00711802|E4|Reported Event|Age Group 2: SOC|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 2: Participants ages 7 to 11 years"
1042341|NCT00711802|E3|Reported Event|Age Group 2: Daptomycin|"Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days~Age Group 2: Participants ages 7 to 11 years"
1042342|NCT00711802|E2|Reported Event|Age Group 1: Standard of Care (SOC)|"SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.~Age Group 1: Participants ages 12 to 17 years"
1042343|NCT00711802|E1|Reported Event|Age Group 1: Daptomycin|"Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days~Age Group 1: Participants ages 12 to 17 years"
1042344|NCT00711646|B3|Baseline|Total|Total of all reporting groups
1042345|NCT00711646|B2|Baseline|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
1042346|NCT00711646|B1|Baseline|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
1042347|NCT00711646|P2|Participant Flow|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
1042348|NCT00711646|P1|Participant Flow|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
1042349|NCT00711646|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
1042350|NCT00711646|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
1042399|NCT00711594|O2|Outcome|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
1042351|NCT00711646|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
1042352|NCT00711646|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
1042353|NCT00711646|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
1042354|NCT00711646|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
1042355|NCT00711646|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
1042356|NCT00711646|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
1042357|NCT00711646|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
1042358|NCT00711646|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
1042359|NCT00711646|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
1042360|NCT00711646|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
1042361|NCT00711646|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
1042362|NCT00711646|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
1042363|NCT00711646|E2|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
1042364|NCT00711646|E1|Reported Event|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
1042365|NCT00711594|B5|Baseline|Total|Total of all reporting groups
1042366|NCT00711594|B4|Baseline|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
1042367|NCT00711594|B3|Baseline|BIBW 50mg (Phase I)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
1042368|NCT00711594|B2|Baseline|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
1042369|NCT00711594|B1|Baseline|BIBW 20mg|Continuous once daily oral treatment with BIBW 2992 20mg tablets
1042370|NCT00711594|P4|Participant Flow|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
1042371|NCT00711594|P3|Participant Flow|BIBW 50mg (Phase I)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
1042372|NCT00711594|P2|Participant Flow|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
1042373|NCT00711594|P1|Participant Flow|BIBW 20mg|Continuous once daily oral treatment with BIBW 2992 20mg tablets
1042374|NCT00711594|O3|Outcome|BIBW 50mg (Phase I)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
1042375|NCT00711594|O2|Outcome|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
1042376|NCT00711594|O1|Outcome|BIBW 20mg|Continuous once daily oral treatment with BIBW 2992 20mg tablets
1042377|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
1042378|NCT00711594|O3|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
1042379|NCT00711594|O2|Outcome|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
1042380|NCT00711594|O1|Outcome|BIBW 30mg|Continuous once daily oral treatment with BIBW 2992 30mg tablets
1042381|NCT00711594|O3|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
1042382|NCT00711594|O2|Outcome|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
1042383|NCT00711594|O1|Outcome|BIBW 30mg|Continuous once daily oral treatment with BIBW 2992 30mg tablets
1042384|NCT00711594|O3|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
1042385|NCT00711594|O2|Outcome|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
1042386|NCT00711594|O1|Outcome|BIBW 30mg|Continuous once daily oral treatment with BIBW 2992 30mg tablets
1042387|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
1042388|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
1042389|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
1042390|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
1042391|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
1042392|NCT00711594|O3|Outcome|BIBW 50mg (Phase I)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
1042393|NCT00711594|O2|Outcome|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
1042394|NCT00711594|O1|Outcome|BIBW 20mg|Continuous once daily oral treatment with BIBW 2992 20mg tablets
1042395|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
1042396|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
1042397|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
1042398|NCT00711594|O3|Outcome|BIBW 50mg (Phase I)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
1042401|NCT00711594|O1|Outcome|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
1042402|NCT00711594|O3|Outcome|BIBW 50mg (Phase I)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
1042403|NCT00711594|O2|Outcome|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
1042404|NCT00711594|O1|Outcome|BIBW 20mg|Continuous once daily oral treatment with BIBW 2992 20mg tablets
1042405|NCT00711594|E4|Reported Event|BIBW 50mg (Phase II)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
1042406|NCT00711594|E3|Reported Event|BIBW 50mg (Phase I)|Continuous once daily oral treatment with BIBW 2992 50mg tablets
1042407|NCT00711594|E2|Reported Event|BIBW 40mg|Continuous once daily oral treatment with BIBW 2992 40mg tablets
1042408|NCT00711594|E1|Reported Event|BIBW 20mg|Continuous once daily oral treatment with BIBW 2992 20mg tablets
1042409|NCT00711555|B1|Baseline|Aprepitant, Dexamethasone, Ondansetron, Multiple Days|
1042410|NCT00711555|P1|Participant Flow|Aprepitant, Dexamethasone, Ondansetron, Multiple Days|
1042411|NCT00711555|O1|Outcome|Aprepitant, Dexamethasone, Ondansetron, Multiple Days|
1042412|NCT00711555|O1|Outcome|Aprepitant, Dexamethasone, Ondansetron, Multiple Days|
1042413|NCT00711555|O1|Outcome|Aprepitant, Dexamethasone, Ondansetron, Multiple Days|
1042414|NCT00711555|O1|Outcome|Aprepitant, Dexamethasone, Ondansetron, Multiple Days|
1042415|NCT00711555|O1|Outcome|Aprepitant, Dexamethasone, Ondansetron, Multiple Days|
1042416|NCT00711529|B3|Baseline|Total|Total of all reporting groups
1042417|NCT00711529|B2|Baseline|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
1042418|NCT00711529|B1|Baseline|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
1042419|NCT00711529|P2|Participant Flow|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
1042420|NCT00711529|P1|Participant Flow|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
1042421|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
1042422|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
1042423|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
1042424|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
1042425|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
1042426|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
1042427|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
1042428|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
1042429|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
1042430|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
1042431|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
1042432|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
1042433|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
1042434|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
1042435|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
1042436|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
1042437|NCT00711529|O2|Outcome|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
1042438|NCT00711529|O1|Outcome|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
1042547|NCT00711490|O1|Outcome|Study Eye|The study eye was treated with sirolimus.
1042601|NCT00711347|O2|Outcome|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
1042439|NCT00711529|E2|Reported Event|Gabapentin|Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily).
1042440|NCT00711529|E1|Reported Event|Hypnotherapy|Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.
1042441|NCT00711516|B3|Baseline|Total|Total of all reporting groups
1042442|NCT00711516|B2|Baseline|Placebo|Placebo tablets matching the armodafinil tablets were titrated during the double-blind treatment period starting with 1 tablet/day on Day 1, increasing to 2 tablets/day on day 2, 3 tablets/day on day 5, and 4 tablets/day on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
1042443|NCT00711516|B1|Baseline|Armodafinil (200 mg/Day)|Armodafinil was titrated during the double-blind treatment period starting with 50 mg/day (1 tablet) on Day 1, increasing to 100 mg/day (2 tablets) on day 2, 150 mg/day (3 tablets) on day 5, and 200 mg/day (4 tablets) on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
1042444|NCT00711516|P2|Participant Flow|Placebo|Placebo tablets matching the armodafinil tablets were titrated during the double-blind treatment period starting with 1 tablet/day on Day 1, increasing to 2 tablets/day on day 2, 3 tablets/day on day 5, and 4 tablets/day on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
1042445|NCT00711516|P1|Participant Flow|Armodafinil (200 mg/Day)|Armodafinil was titrated during the double-blind treatment period starting with 50 mg/day (1 tablet) on Day 1, increasing to 100 mg/day (2 tablets) on day 2, 150 mg/day (3 tablets) on day 5, and 200 mg/day (4 tablets) on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
1042446|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042447|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042448|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042449|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042450|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042451|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042452|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042453|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042454|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042455|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042456|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042457|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042458|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042459|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042460|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042461|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042462|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042463|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042464|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042465|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042466|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042467|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042468|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042469|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042470|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042471|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042472|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042473|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042474|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042475|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042476|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042477|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042478|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042479|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042480|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042595|NCT00711347|O2|Outcome|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
1042596|NCT00711347|O1|Outcome|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
1042481|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042482|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042483|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042484|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042485|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042486|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042487|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042488|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042489|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042490|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042491|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042492|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042493|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042494|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042495|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042496|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042497|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042498|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042499|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042500|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042597|NCT00711347|O2|Outcome|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
1042598|NCT00711347|O1|Outcome|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
1042501|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042502|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042503|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042504|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042505|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042506|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042507|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042508|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042509|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042510|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042511|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042512|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042513|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042514|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042515|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042516|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042517|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042518|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042519|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042520|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042599|NCT00711347|O2|Outcome|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
1042600|NCT00711347|O1|Outcome|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
1042521|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042522|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042523|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042524|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042525|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042526|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042527|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042528|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042529|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042530|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042531|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042532|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042533|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042534|NCT00711516|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablets were provided by Cephalon to patients in bottles of sixty tablets. Patients took a single tablet on Day 1, which was increased by 1 tablet on Days 2, 5, and 8 to a total dose of 4 tablets per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042535|NCT00711516|O1|Outcome|Armodafinil|Armodafinil was provided to patients in bottles of sixty 50 mg tablets. Patients took a 50 mg dose on Day 1, which was increased by 50 mg on Days 2, 5, and 8 to a total dose of 200 mg per day. This was taken as a once daily dose at or before 8 AM, approximately 30 minutes before breakfast.
1042536|NCT00711516|E2|Reported Event|Placebo|Placebo tablets matching the armodafinil tablets were titrated during the double-blind treatment period starting with 1 tablet/day on Day 1, increasing to 2 tablets/day on day 2, 3 tablets/day on day 5, and 4 tablets/day on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
1042537|NCT00711516|E1|Reported Event|Armodafinil (200 mg/Day)|Armodafinil was titrated during the double-blind treatment period starting with 50 mg/day (1 tablet) on Day 1, increasing to 100 mg/day (2 tablets) on day 2, 150 mg/day (3 tablets) on day 5, and 200 mg/day (4 tablets) on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
1042538|NCT00711490|B1|Baseline|Sirolimus|This is a single-arm study with all participants receiving a minimum of two 20 μL (440 μg) sirolimus injections: one injection at baseline and one injection at Month 2. Patients for whom re-treatment criteria were satisfied received additional injections every 2 months thereafter.
1042539|NCT00711490|P1|Participant Flow|Sirolimus|This is a single-arm study with all participants receiving a minimum of two 20 μL (440 μg) sirolimus injections: one injection at baseline and one injection at Month 2. Patients for whom re-treatment criteria were satisfied received additional injections every 2 months thereafter.
1042540|NCT00711490|O2|Outcome|Fellow Eye|The fellow eye was not treated with sirolimus.
1042541|NCT00711490|O1|Outcome|Study Eye|The study eye was treated with sirolimus.
1042542|NCT00711490|O2|Outcome|Fellow Eye|The fellow eye was not treated with sirolimus.
1042543|NCT00711490|O1|Outcome|Study Eye|The study eye was treated with sirolimus.
1042544|NCT00711490|O2|Outcome|Fellow Eye|The fellow eye was not treated with sirolimus.
1042545|NCT00711490|O1|Outcome|Study Eye|The study eye was treated with sirolimus.
1042546|NCT00711490|O2|Outcome|Fellow Eye|The fellow eye was not treated with sirolimus.
1042548|NCT00711490|E1|Reported Event|Sirolimus|This is a single-arm study with all participants receiving a minimum of two 20 μL (440 μg) sirolimus injections: one injection at baseline and one injection at Month 2. Patients for whom re-treatment criteria were satisfied received additional injections every 2 months thereafter.
1042549|NCT00711477|B3|Baseline|Total|Total of all reporting groups
1042550|NCT00711477|B2|Baseline|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
1042551|NCT00711477|B1|Baseline|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
1042552|NCT00711477|P2|Participant Flow|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
1042553|NCT00711477|P1|Participant Flow|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
1042554|NCT00711477|O2|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
1042555|NCT00711477|O1|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
1042556|NCT00711477|O2|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
1042557|NCT00711477|O1|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
1042558|NCT00711477|O2|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
1042559|NCT00711477|O1|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
1042560|NCT00711477|O2|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
1042561|NCT00711477|O1|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
1042562|NCT00711477|O2|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
1042563|NCT00711477|O1|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
1042564|NCT00711477|O2|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
1042565|NCT00711477|O1|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
1042566|NCT00711477|O2|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
1042567|NCT00711477|O1|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
1042568|NCT00711477|O2|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
1042569|NCT00711477|O1|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
1042570|NCT00711477|O2|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
1042571|NCT00711477|O1|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
1042572|NCT00711477|O2|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
1042573|NCT00711477|O1|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
1042574|NCT00711477|O2|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
1042575|NCT00711477|O1|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
1042576|NCT00711477|O2|Outcome|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
1042577|NCT00711477|O1|Outcome|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
1042578|NCT00711477|E2|Reported Event|Placebo|"Placebo tablets~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
1042579|NCT00711477|E1|Reported Event|NB32|"Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day~fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain fMRI scan: fMRI to assess the effects of the drug/placebo on areas of the brain"
1042580|NCT00711425|B1|Baseline|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
1042581|NCT00711425|P1|Participant Flow|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
1042582|NCT00711425|O1|Outcome|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
1042583|NCT00711425|O1|Outcome|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
1042584|NCT00711425|O1|Outcome|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
1042585|NCT00711425|E1|Reported Event|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
1042586|NCT00711347|B3|Baseline|Total|Total of all reporting groups
1042587|NCT00711347|B2|Baseline|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
1042588|NCT00711347|B1|Baseline|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
1042589|NCT00711347|P2|Participant Flow|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
1042590|NCT00711347|P1|Participant Flow|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
1042591|NCT00711347|O2|Outcome|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
1042592|NCT00711347|O1|Outcome|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
1042593|NCT00711347|O2|Outcome|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
1042594|NCT00711347|O1|Outcome|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
1042602|NCT00711347|O1|Outcome|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
1042603|NCT00711347|E2|Reported Event|Healon5|Abbot Medical Optics (AMO) Healon5 used at time of surgery
1042604|NCT00711347|E1|Reported Event|DisCoVisc|Alcon’s DisCoVisc used at time of surgery
1042605|NCT00711191|B4|Baseline|Total|Total of all reporting groups
1042606|NCT00711191|B3|Baseline|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
1042607|NCT00711191|B2|Baseline|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
1042608|NCT00711191|B1|Baseline|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
1042609|NCT00711191|P3|Participant Flow|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
1042610|NCT00711191|P2|Participant Flow|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
1042611|NCT00711191|P1|Participant Flow|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
1042612|NCT00711191|O1|Outcome|CP-870893 Combined Dose Cohorts|"Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.~Subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.~Additional participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles."
1042613|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
1042614|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
1042615|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
1042616|NCT00711191|O1|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
1042617|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
1042977|NCT00710749|E2|Reported Event|Clinic|Voidings recorded with the clinic gold standard.
1042618|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
1042619|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
1042620|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
1042621|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
1042622|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
1042623|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
1042624|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
1042625|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
1042626|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
1042627|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
1042628|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
1042629|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
1042630|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
1042631|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
1042690|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042632|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
1042633|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
1042634|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
1042635|NCT00711191|O1|Outcome|CP-870893 Combined Dose Cohorts|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort) for up to a maximum of 12 cycles. Subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
1042636|NCT00711191|O1|Outcome|CP-870893 Combined Dose Cohorts|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort) for up to a maximum of 12 cycles. Subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
1042637|NCT00711191|O1|Outcome|CP-870893 Combined Dose Cohorts|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort) for up to a maximum of 12 cycles. Subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received chemotherapy on Day 1, 8, and 15 or every 28 day cycle and CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
1042638|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
1042639|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
1042640|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
1042641|NCT00711191|O3|Outcome|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
1042642|NCT00711191|O2|Outcome|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
1042643|NCT00711191|O1|Outcome|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
1042691|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1053937|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
1042644|NCT00711191|E3|Reported Event|CP-870893 0.2 mg/kg (MTD Expansion Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg MTD expansion cohort) for up to a maximum of 12 cycles.
1042645|NCT00711191|E2|Reported Event|CP-870893 0.2 mg/kg (Escalation Cohort)|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 mg/m^2 IV on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 28 day cycle (0.2 mg/kg escalation cohort) for up to a maximum of 12 cycles.
1042646|NCT00711191|E1|Reported Event|CP-870893 0.1 mg/kg|Participants received chemotherapy (gemcitabine) with a starting dose of 1000 milligrams per meter squared (mg/m^2) intravenously (IV) on Day 1, 8, and 15 of every 28 day cycle up to a maximum of 12 cycles. CP-870893 administered IV on Day 3 of every 28 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort) for up to a maximum of 12 cycles.
1042647|NCT00711113|B1|Baseline|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
1042648|NCT00711113|P1|Participant Flow|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
1042649|NCT00711113|O1|Outcome|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
1042650|NCT00711113|O1|Outcome|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
1042651|NCT00711113|O1|Outcome|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
1042652|NCT00711113|E1|Reported Event|OsseoSpeed|Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
1042653|NCT00711100|B1|Baseline|Oral Tobacco Products|Camel Snus, Marlboro Snus, General Snus, Stonewall, Ariva
1042654|NCT00711100|P1|Participant Flow|Oral Tobacco Products|Camel Snus, Marlboro Snus, General Snus, Stonewall, Ariva
1042655|NCT00711100|O4|Outcome|Ariva|Number of participants who preferred this product during abstinence phase
1042656|NCT00711100|O3|Outcome|Stonewall|Number of participants who preferred this product during abstinence phase
1042657|NCT00711100|O2|Outcome|Marlboro Snus|Number of participants who preferred this product during abstinence phase
1042658|NCT00711100|O1|Outcome|Camel Snus|Number of participants who preferred this product during abstinence phase
1042659|NCT00711100|O5|Outcome|General Snus|Number of partiicipants who sampled General Snus
1042660|NCT00711100|O4|Outcome|Ariva|Number of participants who sampled Ariva
1042661|NCT00711100|O3|Outcome|Stonewall|Number of participants who sampled Stonewall
1042662|NCT00711100|O2|Outcome|Marlboro Snus|Number of participants who sampled Marlboro Snus
1042663|NCT00711100|O1|Outcome|Camel Snus|Number of participants who sampled Camel Snus
1042664|NCT00711100|E5|Reported Event|General Snus|Participants who sampled General Snus
1042665|NCT00711100|E4|Reported Event|Ariva|Participants who sampled Ariva
1042666|NCT00711100|E3|Reported Event|Stonewall|Participants who sampled Stonewall
1042667|NCT00711100|E2|Reported Event|Marlboro Snus|Participants who sampled Marlboro Snus
1042668|NCT00711100|E1|Reported Event|Camel Snus|Participant who sampled Camel Snus
1042669|NCT00711087|B3|Baseline|Total|Total of all reporting groups
1042670|NCT00711087|B2|Baseline|ARM 1|Subjects randomized to receive 100 units of BOTOX-A injections on Days 0 and 90.
1042671|NCT00711087|B1|Baseline|ARM 2|Subjects randomized to receive placebo (saline) sham saline injections on Days 0 and 90.
1042672|NCT00711087|P2|Participant Flow|ARM 1|Patients in ARM 1 randomized to receive 100 units of BOTOX-A on Day 0 and Day 90
1042673|NCT00711087|P1|Participant Flow|ARM 2|Patients in ARM 2 randomized to receive placebo (saline) injections on Days 0 and 90.
1042674|NCT00711087|O2|Outcome|ARM 1|Subjects randomized to receive 100 units of BOTOX-A on Days 0 and 90
1042675|NCT00711087|O1|Outcome|ARM 2|Subjects randomized to receive placebo (saline) sham saline injections on Days 0 and 90.
1042676|NCT00711087|E2|Reported Event|ARM 1|"Receiving BOTOX-A~BOTOX-A: Group 1-100 units of BTX-A (Botox®, Allergan Inc., Irvine, CA) on Day 0 and 100 units of BTX-A on Day 90"
1042677|NCT00711087|E1|Reported Event|ARM 2|"Receiving placebo (saline injections)~Saline injection: Group 2-sham saline injections on both Day 0 and Day 90."
1042678|NCT00711022|B1|Baseline|OsseoSpeed|ASTRA TECH Implant System, OsseoSpeed™, all dimensions.
1042679|NCT00711022|P1|Participant Flow|OsseoSpeed|ASTRA TECH Implant System, OsseoSpeed™, all dimensions.
1042680|NCT00711022|O1|Outcome|OsseoSpeed|ASTRA TECH Implant System, OsseoSpeed™, all dimensions.
1042681|NCT00711022|E1|Reported Event|OsseoSpeed|ASTRA TECH Implant System, OsseoSpeed™, all dimensions.
1042682|NCT00711009|B3|Baseline|Total|Total of all reporting groups
1042683|NCT00711009|B2|Baseline|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042684|NCT00711009|B1|Baseline|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042685|NCT00711009|P2|Participant Flow|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042686|NCT00711009|P1|Participant Flow|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042687|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042688|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042689|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042692|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042693|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042694|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042695|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042696|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042697|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042698|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042699|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042700|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042701|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042702|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042703|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042704|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042705|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042706|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042707|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042708|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042709|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042710|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042711|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042712|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042713|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042714|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042715|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042716|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042717|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042718|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042719|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042720|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042721|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042722|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042723|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042724|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042725|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042726|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042727|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042728|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042729|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042730|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042731|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042732|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042733|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042734|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042735|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042736|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042737|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042738|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042739|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042740|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042741|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042742|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042743|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042744|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042745|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042746|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042747|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042748|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042749|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042750|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042751|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042752|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042753|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042754|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042755|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042756|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042757|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042758|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042759|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042760|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042761|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042762|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042763|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042764|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042765|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042766|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042767|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042768|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042769|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042770|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042771|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042772|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042773|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042774|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042775|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042776|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042777|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042778|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042779|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042780|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042781|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042782|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042783|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042784|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042785|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042786|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042787|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042788|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042789|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042790|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042791|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042792|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042793|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042794|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042795|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042796|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042797|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042798|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042799|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042800|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042801|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042802|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042803|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042804|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042805|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042806|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042807|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042808|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042809|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042810|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042811|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042812|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042813|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042814|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042815|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042816|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042817|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042818|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042819|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042820|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042821|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042822|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042823|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042824|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042825|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042826|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042827|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042828|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042829|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042830|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042831|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042832|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042833|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042834|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042835|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042836|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042837|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042838|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042839|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042840|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042841|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042842|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042843|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042844|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042845|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042846|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042847|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042848|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042849|NCT00711009|O2|Outcome|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042850|NCT00711009|O1|Outcome|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042851|NCT00711009|E2|Reported Event|LPV/r + RAL|lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
1042852|NCT00711009|E1|Reported Event|LPV/r + FTC/TDF|lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
1042853|NCT00710996|B4|Baseline|Total|Total of all reporting groups
1042854|NCT00710996|B3|Baseline|Phakic Patients|Phakic patients - Age matched patients who have not had cataract surgery
1042855|NCT00710996|B2|Baseline|AcrySof Clear Intraocular Lens|"AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SA"
1042856|NCT00710996|B1|Baseline|AcrySof Natural Intraocular Lens|"AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SN"
1042857|NCT00710996|P3|Participant Flow|Phakic Patients|Phakic patients - Age matched patients who have not had cataract surgery
1042858|NCT00710996|P2|Participant Flow|AcrySof Clear Intraocular Lens|"AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SA"
1042859|NCT00710996|P1|Participant Flow|AcrySof Natural Intraocular Lens|"AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SN"
1042860|NCT00710996|O3|Outcome|Phakic Patients|Phakic patients - Age matched patients who have not had cataract surgery
1042861|NCT00710996|O2|Outcome|AcrySof Clear Intraocular Lens|"AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SA"
1042862|NCT00710996|O1|Outcome|AcrySof Natural Intraocular Lens|"AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SN"
1042863|NCT00710996|E3|Reported Event|Phakic Patients|Phakic patients - Age matched patients who have not had cataract surgery
1042864|NCT00710996|E2|Reported Event|AcrySof Clear Intraocular Lens|"AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SA"
1042865|NCT00710996|E1|Reported Event|AcrySof Natural Intraocular Lens|"AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SN"
1042975|NCT00710749|O1|Outcome|Disposable Device|Voidings recorded with the disposable device in either first intervention period or second intervention period.
1042866|NCT00710970|B1|Baseline|Single Arm Receiving 20mg Tamoxifen|Tamoxifen : Tamoxifen is administered at 20 mg/day as a single daily oral dose. Tamoxifen is continued until progressive disease or intolerable grade 3 or 4 side effects occur due to tamoxifen.
1042867|NCT00710970|P1|Participant Flow|Single Arm Receiving 20mg Tamoxifen|Tamoxifen : Tamoxifen is administered at 20 mg/day as a single daily oral dose. Tamoxifen is continued until progressive disease or intolerable grade 3 or 4 side effects occur due to tamoxifen.
1042868|NCT00710970|O1|Outcome|Single Arm Receiving 20 mg Tamoxifen|
1042869|NCT00710970|E1|Reported Event|Single Arm Receiving 20mg Tamoxifen|Tamoxifen : Tamoxifen is administered at 20 mg/day as a single daily oral dose. Tamoxifen is continued until progressive disease or intolerable grade 3 or 4 side effects occur due to tamoxifen.
1042870|NCT00710944|B4|Baseline|Total|Total of all reporting groups
1042871|NCT00710944|B3|Baseline|Grafted Sites|"Immediate loading of implants placed in grafted sites (four months healing after grafting).~ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm."
1042872|NCT00710944|B2|Baseline|Healed Ridges|"Immediate loading of implants placed in healed ridges.~ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm."
1042873|NCT00710944|B1|Baseline|Extraction Sockets|"Immediate loading of implants placed in extraction sockets.~ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm."
1042874|NCT00710944|P3|Participant Flow|Grafted Sites|"Immediate loading of implants placed in grafted sites (four months healing after grafting).~OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm."
1042875|NCT00710944|P2|Participant Flow|Healed Ridges|Immediate loading of implants placed in healed ridges. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
1042876|NCT00710944|P1|Participant Flow|Extraction Sockets|Immediate loading of implants placed in extraction sockets. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
1042877|NCT00710944|O3|Outcome|Grafted Sites|"Immediate loading of implants placed in grafted sites (four months healing after grafting).~OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm."
1042878|NCT00710944|O2|Outcome|Healed Ridges|Immediate loading of implants placed in healed ridges. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
1042879|NCT00710944|O1|Outcome|Extraction Sockets|Immediate loading of implants placed in extraction sockets. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
1042880|NCT00710944|E3|Reported Event|Grafted Sites|"Immediate loading of implants placed in grafted sites (four months healing after grafting).~OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm."
1042881|NCT00710944|E2|Reported Event|Healed Ridges|Immediate loading of implants placed in healed ridges. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
1042882|NCT00710944|E1|Reported Event|Extractions Sockets|Immediate loading of implants placed in extraction sockets. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
1042883|NCT00710931|B1|Baseline|ReSTOR +3 Multifocal Lens|Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
1042884|NCT00710931|P1|Participant Flow|ReSTOR +3 Multifocal Lens|Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
1042885|NCT00710931|O1|Outcome|ReSTOR +3 Multifocal Lens|Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
1042886|NCT00710931|E1|Reported Event|ReSTOR +3 Multifocal Lens|Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
1042887|NCT00710905|B1|Baseline|ReSTOR|Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.
1042888|NCT00710905|P1|Participant Flow|ReSTOR|Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.
1042889|NCT00710905|O1|Outcome|ReSTOR|Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.
1042890|NCT00710905|E1|Reported Event|ReSTOR|Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.
1042891|NCT00710879|B3|Baseline|Total|Total of all reporting groups
1042892|NCT00710879|B2|Baseline|Multi-Purpose Solution and Acuvue 2 Lenses|B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
1042893|NCT00710879|B1|Baseline|Multi-purpose Solution and Optima 38 Lenses|Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.
1042894|NCT00710879|P2|Participant Flow|Multi-Purpose Solution and Acuvue 2 Lenses|B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
1042895|NCT00710879|P1|Participant Flow|Multi-purpose Solution and Optima 38 Lenses|Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.
1042896|NCT00710879|O2|Outcome|Multi-Purpose Solution and Acuvue 2 Lenses|B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
1042897|NCT00710879|O1|Outcome|Multi-purpose Solution and Optima 38 Lenses|Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.
1042898|NCT00710879|O2|Outcome|Multi-Purpose Solution and Acuvue 2 Lenses|B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
1042899|NCT00710879|O1|Outcome|Multi-purpose Solution and Optima 38 Lenses|Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.
1042900|NCT00710879|O2|Outcome|Multi-Purpose Solution and Acuvue 2 Lenses|B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
1042901|NCT00710879|O1|Outcome|Multi-purpose Solution and Optima 38 Lenses|Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.
1042902|NCT00710879|E2|Reported Event|Multi-Purpose Solution and Acuvue 2 Lenses|B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
1042903|NCT00710879|E1|Reported Event|Multi-purpose Solution and Optima 38 Lenses|Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.
1042904|NCT00710866|B3|Baseline|Total|Total of all reporting groups
1042905|NCT00710866|B2|Baseline|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
1042906|NCT00710866|B1|Baseline|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
1042907|NCT00710866|P2|Participant Flow|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
1042908|NCT00710866|P1|Participant Flow|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
1042909|NCT00710866|O2|Outcome|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
1042910|NCT00710866|O1|Outcome|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
1042911|NCT00710866|O2|Outcome|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
1042912|NCT00710866|O1|Outcome|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
1042913|NCT00710866|O2|Outcome|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
1042914|NCT00710866|O1|Outcome|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
1042915|NCT00710866|O2|Outcome|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
1042916|NCT00710866|O1|Outcome|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
1042917|NCT00710866|O2|Outcome|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
1042918|NCT00710866|O1|Outcome|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
1042919|NCT00710866|O2|Outcome|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
1042920|NCT00710866|O1|Outcome|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
1042921|NCT00710866|O2|Outcome|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
1042922|NCT00710866|O1|Outcome|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
1042923|NCT00710866|O2|Outcome|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
1042924|NCT00710866|O1|Outcome|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
1042925|NCT00710866|E2|Reported Event|0.25mL VAXIGRIP®|2 doses 0.25mL VAXIGRIP® at months 0, 1
1042926|NCT00710866|E1|Reported Event|0.5mL VAXIGRIP®|2 doses 0.5mL VAXIGRIP® at months 0, 1
1042927|NCT00710840|B3|Baseline|Total|Total of all reporting groups
1042928|NCT00710840|B2|Baseline|TKA Traditional|Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
1042929|NCT00710840|B1|Baseline|TKA Min|Minimally Invasive Total Knee Arthroplasty [TKA(min)]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
1042930|NCT00710840|P2|Participant Flow|TKA Traditional|Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
1042931|NCT00710840|P1|Participant Flow|TKA Min|Minimally Invasive Total Knee Arthroplasty [TKA(min)]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
1042932|NCT00710840|O2|Outcome|TKA Traditional|Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
1042933|NCT00710840|O1|Outcome|TKA Min|Minimally Invasive Total Knee Arthroplasty [TKA(min)]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
1042934|NCT00710840|O2|Outcome|TKA Traditional|Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
1042935|NCT00710840|O1|Outcome|TKA Min|Minimally Invasive Total Knee Arthroplasty [TKA(min)]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
1042976|NCT00710749|E3|Reported Event|Digital Device|Voidings recorded with the digital device in either first intervention period or second intervention period.
1042936|NCT00710840|O2|Outcome|TKA Traditional|Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
1042937|NCT00710840|O1|Outcome|TKA Min|Minimally Invasive Total Knee Arthroplasty [TKA(min)]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
1042938|NCT00710840|O2|Outcome|TKA Traditional|Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
1042939|NCT00710840|O1|Outcome|TKA Min|Minimally Invasive Total Knee Arthroplasty [TKA(min)]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
1042940|NCT00710840|E2|Reported Event|TKA Traditional|Total Knee Arthroplasty (TKA): TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
1042941|NCT00710840|E1|Reported Event|TKA Min|Minimally Invasive Total Knee Arthroplasty [TKA(min)]: TKA(min) is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA(min), as opposed to TKA, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
1042942|NCT00710814|B3|Baseline|Total|Total of all reporting groups
1042943|NCT00710814|B2|Baseline|Placebo - Leptin|Placebo self-administered subcutaneously twice each day for 16 weeks, then Leptin for 16 weeks.
1042944|NCT00710814|B1|Baseline|Leptin - Placebo|Leptin self-administered subcutaneously twice each day for 16 weeks, then Placebo for 16 weeks.
1042945|NCT00710814|P2|Participant Flow|Placebo-Leptin|Placebo self-administered subcutaneously twice each day for 16 weeks, then Leptin for 16 weeks.
1042946|NCT00710814|P1|Participant Flow|Leptin-Placebo|Leptin self-administered subcutaneously twice each day for 16 weeks, then Placebo for 16 weeks.
1042947|NCT00710814|O2|Outcome|Placebo Intervention|"Participants in the Placebo-Leptin arm were randomized to receive placebo for the first 16 weeks, and participants in the Leptin-Placebo arm were randomized to receive placebo for the second 16 weeks.~Both Leptin and placebo were self-administered subcutaneously twice per day."
1042948|NCT00710814|O1|Outcome|Leptin Intervention|"Participants in the Leptin-Placebo arm were randomized to first receive Leptin for the first 16 weeks, and participants in the Placebo-Leptin arm were randomized to receive Leptin for the second 16 weeks.~Both Leptin and placebo were self-administered subcutaneously twice per day."
1042949|NCT00710814|E2|Reported Event|Placebo Intervention|"This group Placebo Intervention inlcudes the adverse events that were observed while the subjects in either crossover arms when they received Placebo only."
1042950|NCT00710814|E1|Reported Event|Leptin Intervention|"This group Leptin Intervention inlcudes the adverse events that were observed while the subjects in either crossover arms when they received Leptin only."
1042951|NCT00710762|B3|Baseline|Total|Total of all reporting groups
1042952|NCT00710762|B2|Baseline|Placebo|Patients were treated with matching placebo twice daily
1042953|NCT00710762|B1|Baseline|Nintedanib|Patients were treated with 250mg nintedanib twice daily
1042954|NCT00710762|P2|Participant Flow|Placebo|Patients were treated with matching placebo twice daily
1042955|NCT00710762|P1|Participant Flow|Nintedanib|Patients were treated with 250mg nintedanib twice daily
1042956|NCT00710762|O2|Outcome|Placebo|Patients were treated with matching placebo twice daily
1042957|NCT00710762|O1|Outcome|Nintedanib|Patients were treated with 250mg nintedanib twice daily
1042958|NCT00710762|O2|Outcome|Placebo|Patients were treated with matching placebo twice daily
1042959|NCT00710762|O1|Outcome|Nintedanib|Patients were treated with 250mg nintedanib twice daily
1042960|NCT00710762|O2|Outcome|Placebo|Patients were treated with matching placebo twice daily
1042961|NCT00710762|O1|Outcome|Nintedanib|Patients were treated with 250mg nintedanib twice daily
1042962|NCT00710762|O2|Outcome|Placebo|Patients were treated with matching placebo twice daily
1042963|NCT00710762|O1|Outcome|Nintedanib|Patients were treated with 250mg nintedanib twice daily
1042964|NCT00710762|O2|Outcome|Placebo|Patients were treated with matching placebo twice daily
1042965|NCT00710762|O1|Outcome|Nintedanib|Patients were treated with 250mg nintedanib twice daily
1042966|NCT00710762|O2|Outcome|Placebo|Patients were treated with matching placebo twice daily
1042967|NCT00710762|O1|Outcome|Nintedanib|Patients were treated with 250mg nintedanib twice daily
1042968|NCT00710762|E2|Reported Event|Placebo|Patients were treated with matching placebo twice daily.
1042969|NCT00710762|E1|Reported Event|Nintedanib|Patients were treated with 250mg nintedanib twice daily.
1042970|NCT00710749|B1|Baseline|Entire Study Population|Includes groups randomized to use the Disposable device first and the Digital device first.
1042971|NCT00710749|P2|Participant Flow|Digital Device First, Then Disposable Device|12 voidings recorded with the digital device in the first intervention period, followed by 12 voidings recorded with the disposable device in the second intervention period.
1042972|NCT00710749|P1|Participant Flow|Disposable Device First, Then Digital Device|12 voidings recorded with the disposable device in the first intervention period, followed by 12 voidings recorded with the digital device in the second intervention period.
1042973|NCT00710749|O3|Outcome|Digital Device|Voidings recorded with the digital device in either first intervention period or second intervention period.
1042974|NCT00710749|O2|Outcome|Clinic|Voidings recorded with the clinic gold standard.
1053938|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
1042978|NCT00710749|E1|Reported Event|Disposable Device|Voidings recorded with the disposable device in either first intervention period or second intervention period.
1042979|NCT00710606|B3|Baseline|Total|Total of all reporting groups
1042980|NCT00710606|B2|Baseline|Normal Weight Subjects|Normal weight subjects (BMI 19-24.9)
1042981|NCT00710606|B1|Baseline|Obese Subjects|Obese subjects (BMI 30-39.9)
1042982|NCT00710606|P2|Participant Flow|Normal Weight Subjects|Normal weight subjects (BMI 19-24.9) received two contraceptive hormonal rings. During the second cycle of ring use, subjects returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.
1042983|NCT00710606|P1|Participant Flow|Obese Subjects|Obese subjects (BMI 30-39.9) received two contraceptive hormonal rings. During the second cycle of ring use, subjects returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.
1042984|NCT00710606|O2|Outcome|Normal Weight Subjects|Normal weight subjects (BMI 19-24.9)
1042985|NCT00710606|O1|Outcome|Obese Subjects|Obese subjects (BMI 30-39.9)
1042986|NCT00710606|O2|Outcome|Normal Weight Subjects|Normal weight subjects (BMI 19-24.9)
1042987|NCT00710606|O1|Outcome|Obese Subjects|Obese subjects (BMI 30-39.9)
1042988|NCT00710606|O2|Outcome|Obese|Women of normal weight and obese received two contraceptive rings. During the second cycle of ring use, subject returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.
1042989|NCT00710606|O1|Outcome|Normal Weight|Women of normal weight and obese received two contraceptive rings. During the second cycle of ring use, subject returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.
1042990|NCT00710606|E2|Reported Event|Normal Weight Subjects|Normal weight subjects (BMI 19-24.9)
1042991|NCT00710606|E1|Reported Event|Obese Subjects|Obese subjects (BMI 30-39.9)
1042992|NCT00710593|B3|Baseline|Total|Total of all reporting groups
1042993|NCT00710593|B2|Baseline|Group B|Participants who have been receiving highly active retroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.
1042994|NCT00710593|B1|Baseline|Group A|Participants who are antiretroviral (ART) naïve or, if ART-exposed, have not received highly active antiretroviral therapy(HAART) for at least the six months prior to study entry.
1042995|NCT00710593|P2|Participant Flow|HAART|Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.
1042996|NCT00710593|P1|Participant Flow|ART/HAART NAIVE|Participants who are antiretroviral (ART) naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry.
1042997|NCT00710593|O2|Outcome|Vaccine Report Card (VRC)|Participants at sites randomized to the VRC recorded any of their side effects.
1042998|NCT00710593|O1|Outcome|Telephone Response System (TRS)|Participants at sites randomized to the TRS called the TRS once a day to report any side effects they were experiencing.
1042999|NCT00710593|O2|Outcome|Vaccine Report Card (VRC)|Participants at sites randomized to the VRC recorded any of their side effects. Participants were directed to call the clinical site staff or return to the clinic for evaluation if they were concerned about their signs or symptoms or if any symptoms appeared severe. Participants brought their VRC with them to all of their study visits. The completed cards were collected after all vaccine study visits were completed.
1043000|NCT00710593|O1|Outcome|Telephone Response System (TRS)|Participants at sites randomized to the TRS called the TRS once a day to report any side effects they were experiencing.
1043001|NCT00710593|O2|Outcome|Higher NSSB|Higher NSSB is defined as participants who had a higher need for safer sexual behaviors (summary score is equal to or greater than the median).
1043002|NCT00710593|O1|Outcome|Lower NSSB|Lower NSSB is defined as participants who had a lower need for safer sexual behaviors (summary score is less than the median).
1043003|NCT00710593|O2|Outcome|Higher NSSB|Higher NSSB is defined as participants who had a higher need for safer sexual behaviors (summary score is equal to or greater than the median).
1043004|NCT00710593|O1|Outcome|Lower NSSB|Lower NSSB is defined as participants who had a lower need for safer sexual behaviors (summary score is less than the median).
1043005|NCT00710593|O2|Outcome|Group B|Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.
1043006|NCT00710593|O1|Outcome|Group A|Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry.
1043007|NCT00710593|O2|Outcome|Group B|Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.
1043008|NCT00710593|O1|Outcome|Group A|Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry.
1043009|NCT00710593|O2|Outcome|Group B|Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.
1043010|NCT00710593|O1|Outcome|Group A|Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry.
1043011|NCT00710593|O2|Outcome|Group B|Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.
1043041|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
1043042|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
1043012|NCT00710593|O1|Outcome|Group A|Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry. All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).
1043013|NCT00710593|O2|Outcome|Group B|Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.
1043014|NCT00710593|O1|Outcome|Group A|Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry.
1043015|NCT00710593|O2|Outcome|Group B|Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.
1043016|NCT00710593|O1|Outcome|Group A|Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry.
1043017|NCT00710593|O2|Outcome|Group B|Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry.
1043018|NCT00710593|O1|Outcome|Group A|Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry.
1043019|NCT00710593|O2|Outcome|Group B|Received highly active antiretroviral therapy (HAART) for at least six months at the time of study entry.
1043020|NCT00710593|O1|Outcome|Group A|Antiretroviral therapy (ART) naïve or if ART exposed, have not received highlight active antiretroviral (HAART) for at least the six months prior to study entry.
1043021|NCT00710593|O1|Outcome|All Study Participants Compared w/ Historical Comparison Group|"This is a one sample test. This one-arm comparison compared the mean geometric mean titers (GMTs) to HPV-18 four weeks post vaccine dose #3 in study subjects with cluster of differentiation 4 (CD4+) T-cell counts > 350 mm3 with a null value: the mean GMT of HIV-negative and HPV vaccinated subjects in industry-sponsored trials.~Comparing data collected from this study to results from a historical comparison group is part of the protocol design."
1043022|NCT00710593|O1|Outcome|All Study Participants Compared w/ Historical Comparison Group|"This is a one sample test. This one-arm comparison compared the mean geometric mean titers (GMTs) to HPV-16 four weeks post vaccine dose #3 in study subjects with cluster of differentiation 4 (CD4+) T-cell counts > 350 mm3 with a null value: the mean GMT of HIV-negative and HPV vaccinated subjects in industry-sponsored trials.~Comparing data collected from this study to results from a historical comparison group is part of the protocol design."
1043023|NCT00710593|O1|Outcome|All Study Participants Compared w/ Historical Comparison Group|"This is a one sample test. This one-arm comparison compared the mean geometric mean titers (GMTs) to HPV-11 four weeks post vaccine dose #3 in study subjects with cluster of differentiation 4 (CD4+) T-cell counts > 350 mm3 with a null value: the mean GMT of HIV-negative and HPV vaccinated subjects in industry-sponsored trials.~Comparing data collected from this study to results from a historical comparison group is part of the protocol design."
1043024|NCT00710593|O1|Outcome|All Study Participants|The results are reported for participants in both Group A and Group B.
1043025|NCT00710593|O1|Outcome|All Study Participants|The results are reported for participants in both Group A and Group B.
1043026|NCT00710593|O1|Outcome|All Study Participants|The results are reported for participants in both Group A and Group B.
1043027|NCT00710593|O1|Outcome|All Study Participants|The results are reported for all study participants in both Group A and Group B.
1043028|NCT00710593|O1|Outcome|All Study Participants|All study participants who were administered vaccine doses #1, 2, and/or 3.
1043029|NCT00710593|O1|Outcome|All Study Participants Compared w/ Historical Comparison Group|The results are reported for all participants in both Group A and Group B.
1043030|NCT00710593|O1|Outcome|All Study Participants Compared w/ Historical Comparison Group|The results are reported for all participants in both Group A and Group B.
1043031|NCT00710593|O1|Outcome|All Study Participants Compared w/ Historical Comparison Group|The results are reported for all participants in both Group A and Group B.
1043032|NCT00710593|O1|Outcome|All Study Participants Compared w/ Historical Comparison Group|The results are reported for all participants in both Group A and Group B.
1043033|NCT00710593|O1|Outcome|All Study Participants Compared w/ Historical Comparison Group|"This is a one sample test. This one-arm comparison compared the mean geometric mean titers (GMTs) to HPV-6 four weeks post vaccine dose #3 in study subjects with cluster of differentiation 4 (CD4+) T-cell counts > 350 mm3 with a null value: the mean GMT of HIV-negative and HPV vaccinated subjects in industry-sponsored trials.~Comparing data collected from this study to results from a historical comparison group is part of the protocol design."
1043034|NCT00710593|E2|Reported Event|Group B: Has Been Receiving HAART for > 6 Months, With Two HIV|Participants who have been receiving HAART for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry. All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).
1043035|NCT00710593|E1|Reported Event|Group A: HAART naïve or, if HAART Exposed, Has Not Received HA|Participants who are ART naïve or, if ART-exposed, have not received HAART for at least the six months prior to study entry. All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).
1043036|NCT00710554|B3|Baseline|Total|Total of all reporting groups
1043037|NCT00710554|B2|Baseline|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
1043038|NCT00710554|B1|Baseline|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
1043039|NCT00710554|P2|Participant Flow|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
1043040|NCT00710554|P1|Participant Flow|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
1043043|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
1043044|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
1043045|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
1043046|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
1043047|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
1043048|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
1043049|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
1043050|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
1043051|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
1043052|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
1043053|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
1043054|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
1043055|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
1043056|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
1043057|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
1043058|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
1043059|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
1043060|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
1043061|NCT00710554|O2|Outcome|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
1043062|NCT00710554|O1|Outcome|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
1043063|NCT00710554|E2|Reported Event|Placebo|Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
1043064|NCT00710554|E1|Reported Event|Sativex|Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
1043065|NCT00710424|B3|Baseline|Total|Total of all reporting groups
1043066|NCT00710424|B2|Baseline|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
1043067|NCT00710424|B1|Baseline|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
1043068|NCT00710424|P2|Participant Flow|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
1043069|NCT00710424|P1|Participant Flow|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
1043070|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
1043071|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
1043072|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
1043073|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
1043074|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
1043075|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
1043076|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
1043077|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
1043078|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
1043079|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
1043080|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
1043081|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
1043082|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
1043083|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
1043084|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
1043085|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
1043086|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
1043087|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
1043088|NCT00710424|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
1043089|NCT00710424|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
1043090|NCT00710424|E2|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
1043091|NCT00710424|E1|Reported Event|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
1043092|NCT00710385|B1|Baseline|Challenge Doses|This study employs a within-subjects design, all participant experience all challenge doses.
1043093|NCT00710385|P1|Participant Flow|Intravenous Challenge Doses|This study employs a within-subjects design, all participants experienced all 7 intravenous challenge doses. The challenge doses were administered under 3 sublingual buprenorphine maintenance conditions. The data presented were collapsed across the 3 sublingual groups.
1043094|NCT00710385|O7|Outcome|Placebo|Control intravenous placebo drug administration.
1043095|NCT00710385|O6|Outcome|High Bup/Nal Dose|Higher doses of intravenous buprenorphine +naloxone
1043096|NCT00710385|O5|Outcome|Lower Bup/Nal Dose|Lower doses of intravenous buprenorphine + naloxone.
1043097|NCT00710385|O4|Outcome|High Bup Dose|Higher doses of intravenous buprenorphine
1043098|NCT00710385|O3|Outcome|Low Bup Dose|Lower doses of intravenous buprenorphine alone.
1043099|NCT00710385|O2|Outcome|Naloxone|Intravenous Naloxone HCl
1043100|NCT00710385|O1|Outcome|Heroin|Intravenous heroin 25 mg
1043101|NCT00710385|O7|Outcome|Placebo|Control intravenous placebo drug administration.
1043102|NCT00710385|O6|Outcome|High Bup/Nal Dose|Higher doses of intravenous buprenorphine +naloxone
1043103|NCT00710385|O5|Outcome|Lower Bup/Nal Dose|Lower doses of intravenous buprenorphine + naloxone.
1043104|NCT00710385|O4|Outcome|High Bup Dose|Higher doses of intravenous buprenorphine
1043105|NCT00710385|O3|Outcome|Low Bup Dose|Lower doses of intravenous buprenorphine alone.
1043106|NCT00710385|O2|Outcome|Naloxone|Intravenous Naloxone HCl
1043107|NCT00710385|O1|Outcome|Heroin|Intravenous heroin 25 mg
1043108|NCT00710385|E1|Reported Event|Combined for All Study Conditions|This study employed a within-subjects design, all participants experienced all study conditions.
1043109|NCT00710203|B1|Baseline|Study Arm|10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference, and a third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine. A fourth lesion will not be treated and will serve as a control.
1043110|NCT00710203|P1|Participant Flow|Study Arm|10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference, and a third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine. A fourth lesion will not be treated and will serve as a control.
1043111|NCT00710203|O4|Outcome|No Treatment|Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
1043112|NCT00710203|O3|Outcome|Electrodesiccation|Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
1043113|NCT00710203|O2|Outcome|Curettage|Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
1043114|NCT00710203|O1|Outcome|Pulsed Dye Laser|Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.
1043115|NCT00710203|O4|Outcome|No Treatment|Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
1043116|NCT00710203|O3|Outcome|Electrodesiccation|Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
1043117|NCT00710203|O2|Outcome|Curettage|Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
1043118|NCT00710203|O1|Outcome|Pulsed Dye Laser|Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.
1043119|NCT00710203|O4|Outcome|No Treatment|Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
1043120|NCT00710203|O3|Outcome|Electrodesiccation|Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
1043121|NCT00710203|O2|Outcome|Curettage|Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
1043122|NCT00710203|O1|Outcome|Pulsed Dye Laser|Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.
1043123|NCT00710203|O4|Outcome|No Treatment|Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
1043124|NCT00710203|O3|Outcome|Electrodesiccation|Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
1043125|NCT00710203|O2|Outcome|Curettage|Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
1043126|NCT00710203|O1|Outcome|Pulsed Dye Laser|Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.
1043127|NCT00710203|O4|Outcome|No Treatment|Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
1043128|NCT00710203|O3|Outcome|Electrodesiccation|Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
1043129|NCT00710203|O2|Outcome|Curettage|Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
1043130|NCT00710203|O1|Outcome|Pulsed Dye Laser|Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.
1043131|NCT00710203|E4|Reported Event|No Treatment|10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. Four lesions are selected on each subject for study. A fourth lesion will not be treated and will serve as a control.
1043132|NCT00710203|E3|Reported Event|Electrodesiccation|10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. Four lesions are selected on each subject for study. A third lesion will be treated with electrodesiccation after infiltration of 1% lidocaine with epinephrine.
1043133|NCT00710203|E2|Reported Event|Curettage|10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. Four lesions are selected on each subject for study. A second lesion will be treated with curettage with or without anesthetic, depending on the patient's preference.
1043134|NCT00710203|E1|Reported Event|Pulsed Dye Laser|10 patients will be recruited from the University of California, Davis Department of Dermatology. Digital images will be taken immediately prior to treatment. Four lesions are selected on each subject for study. One lesion will be chosen for treatment with the pulsed dye laser with a 7 mm spot size. A single 10 J/cm2 pulse with 10 ms pulse duration will be used to treat the lesion.
1043135|NCT00710021|B4|Baseline|Total|Total of all reporting groups
1043136|NCT00710021|B3|Baseline|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1043137|NCT00710021|B2|Baseline|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
1043138|NCT00710021|B1|Baseline|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
1043139|NCT00710021|P3|Participant Flow|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1043140|NCT00710021|P2|Participant Flow|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
1043141|NCT00710021|P1|Participant Flow|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
1043142|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
1043143|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1043144|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
1043145|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
1043146|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
1043147|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1043148|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
1043149|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
1043150|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
1043151|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1043152|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
1043153|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
1043154|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
1043155|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1043156|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
1043157|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
1043158|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
1043159|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1043160|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
1043161|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
1043162|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
1043163|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1043164|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
1043165|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
1043166|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
1043167|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1043168|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
1043169|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
1043170|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
1043171|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1043172|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
1043173|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
1043174|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
1043175|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1043176|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
1043177|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
1043178|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
1043179|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1043180|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
1043181|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
1043182|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
1043183|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1043184|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
1043185|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
1043186|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
1043187|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1043188|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
1043189|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
1043190|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
1043269|NCT00709878|B5|Baseline|Total|Total of all reporting groups
1043191|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1043192|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
1043193|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
1043194|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
1043195|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1043196|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
1043197|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
1043198|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
1043199|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1043200|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
1043201|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
1043202|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
1043203|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1043204|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
1043205|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
1043206|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
1043207|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1043208|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
1043209|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
1043210|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
1043211|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1043212|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
1043213|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
1043214|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
1043215|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1043216|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
1043217|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
1043218|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
1043219|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1043220|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
1043221|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
1043222|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
1043223|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1043224|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
1043225|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
1043226|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
1043227|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1043228|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
1043229|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
1043270|NCT00709878|B4|Baseline|Patients Treated With Erlotinib (E)|Patients treated with erlotinib who developed skin toxicities and have been biopsied for a skin rash.
1043230|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
1043231|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1043232|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
1043233|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
1043234|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
1043235|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1043236|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
1043237|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
1043238|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
1043239|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1043240|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
1043241|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
1043242|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
1043243|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1043244|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
1043245|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
1043246|NCT00710021|O4|Outcome|Vitamin D3 2000 and 4000 IU (Pooled )|This is a statistically pooled group of those participants randomized to either vitamin D3 2,000 IU or vitamin D3 4,000 IU treatment (e.g., pooled group for statistical analysis purposes only).
1043247|NCT00710021|O3|Outcome|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1043248|NCT00710021|O2|Outcome|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
1043249|NCT00710021|O1|Outcome|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
1043250|NCT00710021|E3|Reported Event|Vitamin D3 4000 IU|Participants received a 12-week course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).
1043251|NCT00710021|E2|Reported Event|Vitamin D3 2000 IU|Participants received a 12-week course of oral Vitamin D3 (cholecalciferol, 2,000 international units [IU] daily).
1043252|NCT00710021|E1|Reported Event|Placebo|Participants received a 12-week course of oral vitamin D3-placebo (cholecalciferol placebo, 1 dose daily).
1043253|NCT00709956|B3|Baseline|Total|Total of all reporting groups
1043254|NCT00709956|B2|Baseline|Placebo / Iloprost (5 µg)|Single dose double-blind placebo on study day 2 followed by single dose double-blind active iloprost (5µg) on study day 3
1043255|NCT00709956|B1|Baseline|Iloprost (5µg) / Placebo|Single dose double-blind active iloprost (5µg) on study day 2 followed by single dose double-blind placebo on study day 3
1043256|NCT00709956|P2|Participant Flow|Placebo / Iloprost (5 µg)|Single dose double-blind placebo on study day 2 followed by single dose double-blind active iloprost (5µg) on study day 3
1043257|NCT00709956|P1|Participant Flow|Iloprost (5µg) / Placebo|Single dose double-blind active iloprost (5µg) on study day 2 followed by single dose double-blind placebo on study day 3
1043258|NCT00709956|O2|Outcome|Borg Dyspnea Score After Iloprost (5 µg) Treatment|
1043259|NCT00709956|O1|Outcome|Borg Dyspnea Score After Placebo Treatment|
1043260|NCT00709956|O2|Outcome|6MWD After Iloprost (5 µg) Treatment|
1043261|NCT00709956|O1|Outcome|6MWD After Placebo Treatment|
1043262|NCT00709956|E2|Reported Event|Placebo / Iloprost (5 µg)|Single dose double-blind placebo on study day 2 followed by single dose double-blind active iloprost (5µg) on study day 3
1043263|NCT00709956|E1|Reported Event|Iloprost (5µg) / Placebo|Single dose double-blind active iloprost (5µg) on study day 2 followed by single dose double-blind placebo on study day 3
1043264|NCT00709891|B1|Baseline|Cobas® 4800 HPV Test|The cobas 4800 human papillomavirus (HPV) Test combines in a single assay the identification of pooled high-risk oncogenic HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), as well as genotypes 16 and 18 individually.
1043265|NCT00709891|P1|Participant Flow|Cobas® 4800 HPV Test|The cobas 4800 human papillomavirus (HPV) Test combines in a single assay the identification of pooled high-risk oncogenic HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), as well as genotypes 16 and 18 individually.
1043266|NCT00709891|O1|Outcome|Cobas® 4800 HPV Test|The cobas 4800 human papillomavirus (HPV) Test combines in a single assay the identification of pooled high-risk oncogenic HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), as well as genotypes 16 and 18 individually.
1043267|NCT00709891|O1|Outcome|Cobas® 4800 HPV Test|The cobas 4800 human papillomavirus (HPV) Test combines in a single assay the identification of pooled high-risk oncogenic HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), as well as genotypes 16 and 18 individually.
1043268|NCT00709891|E1|Reported Event|Cobas® 4800 HPV Test|The cobas 4800 human papillomavirus (HPV) Test combines in a single assay the identification of pooled high-risk oncogenic HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), as well as genotypes 16 and 18 individually.
1043271|NCT00709878|B3|Baseline|Patients Treated With Panitumumab (P)|Patients treated with panitumumab who developed skin toxicities and have been biopsied for skin rash.
1043272|NCT00709878|B2|Baseline|Patients Treated With Cetuximab (C)|Patients treated with cetuximab who developed skin toxicities and have been biopsied for skin rash.
1043273|NCT00709878|B1|Baseline|Patients Treated With Lapatinib (L)|Patients treated with lapatinib who developed skin toxicities and have been biopsied for skin rash.
1043274|NCT00709878|P4|Participant Flow|Patients Treated With Erlotinib (E)|Patients treated with erlotinib who developed skin toxicities and have been biopsied for a skin rash.
1043275|NCT00709878|P3|Participant Flow|Patients Treated With Panitumumab (P)|Patients treated with panitumumab who developed skin toxicities and have been biopsied for skin rash.
1043276|NCT00709878|P2|Participant Flow|Patients Treated With Cetuximab (C)|Patients treated with cetuximab who developed skin toxicities and have been biopsied for skin rash.
1043277|NCT00709878|P1|Participant Flow|Patients Treated With Lapatinib (L)|Patients treated with lapatinib who developed skin toxicities and have been biopsied for skin rash.
1043278|NCT00709878|O4|Outcome|Patients Treated With Erlotinib (E)|Patients treated with erlotinib who developed skin toxicities and have been biopsied for a skin rash.
1043279|NCT00709878|O3|Outcome|Patients Treated With Panitumumab (P)|Patients treated with panitumumab who developed skin toxicities and have been biopsied for skin rash.
1043280|NCT00709878|O2|Outcome|Patients Treated With Cetuximab (C)|Patients treated with cetuximab who developed skin toxicities and have been biopsied for skin rash.
1043281|NCT00709878|O1|Outcome|Patients Treated With Lapatinib (L)|Patients treated with lapatinib who developed skin toxicities and have been biopsied for skin rash.
1043282|NCT00709878|E4|Reported Event|Patients Treated With Erlotinib (E)|Patients treated with erlotinib who developed skin toxicities and have been biopsied for a skin rash.
1043283|NCT00709878|E3|Reported Event|Patients Treated With Panitumumab (P)|Patients treated with panitumumab who developed skin toxicities and have been biopsied for skin rash.
1043284|NCT00709878|E2|Reported Event|Patients Treated With Cetuximab (C)|Patients treated with cetuximab who developed skin toxicities and have been biopsied for skin rash.
1043285|NCT00709878|E1|Reported Event|Patients Treated With Lapatinib (L)|Patients treated with lapatinib who developed skin toxicities and have been biopsied for skin rash.
1043286|NCT00709852|B1|Baseline|Entire Study Population|Includes participants who received either treatment
1043287|NCT00709852|P2|Participant Flow|Gadoteridol (ProHance) : Gadobutrol (Gadavist, BAY86-4875)|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. in Period 1 and a single dose of gadobutrol 0.1 mmol/kg bw via i.v. in Period 2.
1043288|NCT00709852|P1|Participant Flow|Gadobutrol (Gadavist, BAY86-4875) : Gadoteridol (ProHance)|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) in Period 1 and a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. in Period 2.
1043289|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043290|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
1043291|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043292|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
1043293|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043294|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
1043295|NCT00709852|O1|Outcome|Combined Gadobutrol vs. Combined Gadoteridol|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) and a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043296|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043297|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
1043298|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043299|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043300|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
1043301|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043302|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043303|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
1043304|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043305|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043306|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
1043307|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043308|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043309|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
1043310|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043311|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
1043312|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043313|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
1043314|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043315|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
1043316|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043317|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
1043318|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043319|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
1043320|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043321|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043322|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043323|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043324|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043325|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043326|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043327|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043328|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043329|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043330|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043331|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043332|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
1043333|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043334|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
1043335|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043336|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
1043337|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043338|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
1043339|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043340|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
1043341|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043342|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
1043343|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043344|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043345|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
1043346|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043347|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
1043348|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043349|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
1043350|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043351|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043352|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043353|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043354|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043355|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043356|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
1043357|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043358|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
1043359|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043360|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
1043361|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043362|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043363|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
1043364|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043365|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
1043366|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043367|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043368|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043369|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043370|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
1043371|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043372|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
1043373|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043374|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043375|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
1043376|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043377|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
1043378|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043379|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
1043380|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043381|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
1043382|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043383|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043384|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043385|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043386|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043387|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043388|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043389|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043390|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
1043391|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043392|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
1043393|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043394|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
1043395|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043396|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
1043397|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043398|NCT00709852|O2|Outcome|Gadoteridol-enhanced Compared to Gadobutrol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. Lesions detected by Combined Unenhanced/Gadoteridol-enhanced MRI were compared to Combined Unenhanced/Gadobutrol-enhanced MRI.
1043399|NCT00709852|O1|Outcome|Gadobutrol-enhanced Compared to Gadoteridol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. Lesions detected by Combined Unenhanced/Gadobutrol-enhanced MRI were compared to Combined Unenhanced/Gadoteridol-enhanced MRI.
1043444|NCT00709826|P1|Participant Flow|Apricoxib/Gemcitabine/Erlotinib|Patients randomized to receive apricoxib + gemcitabine + erlotinib.
1053939|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
1043445|NCT00709826|O2|Outcome|Placebo/Gemcitabine/Erlotinib|Patients randomized to receive placebo + gemcitabine + erlotinib.
1043400|NCT00709852|O2|Outcome|Gadoteridol-enhanced Compared to Unenhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. Lesions detected by Combined Unenhanced/Gadoteridol-enhanced MRI were compared to Unenhanced MRI.
1043401|NCT00709852|O1|Outcome|Unenhanced Compared to Gadoteridol-enhanced|Participants had diagnostic imaging before receiving any contrast agent. Lesions detected by Unenhanced MRI were compared to Combined Unenhanced/Gadoteridol-enhanced MRI.
1043402|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced Compared to Unenhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous). Lesions detected by Combined Unenhanced/Gadobutrol-enhanced MRI were compared to Unenhanced MRI.
1043403|NCT00709852|O1|Outcome|Unenhanced Compared to Combined Unenhanced/Gadobutrol-enhanced|Participants had diagnostic imaging before receiving any contrast agent. Lesions detected by Unenhanced MRI were compared to Combined Unenhanced/Gadobutrol-enhanced MRI.
1043404|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043405|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
1043406|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043407|NCT00709852|O1|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v.
1043408|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043409|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043410|NCT00709852|O2|Outcome|Combined Unenhanced/Gadoteridol-enhanced|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043411|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043412|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
1043413|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043414|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
1043415|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043416|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
1043417|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043418|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
1043419|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043420|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
1043421|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043422|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
1043423|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043424|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
1043425|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043426|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
1043427|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043428|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
1043429|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043430|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
1043431|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043432|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
1043433|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043434|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
1043435|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043436|NCT00709852|O2|Outcome|Combined Unenhanced/Gadobutrol-enhanced|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
1043437|NCT00709852|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1043438|NCT00709852|E2|Reported Event|Gadoteridol (ProHance)|Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v.
1043439|NCT00709852|E1|Reported Event|Gadobutrol (Gadavist, BAY86-4875)|Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous)
1043440|NCT00709826|B3|Baseline|Total|Total of all reporting groups
1043441|NCT00709826|B2|Baseline|Placebo/Gemcitabine/Erlotinib|Patients randomized to receive placebo + gemcitabine + erlotinib.
1043442|NCT00709826|B1|Baseline|Apricoxib/Gemcitabine/Erlotinib|Patients randomized to receive apricoxib + gemcitabine + erlotinib.
1043443|NCT00709826|P2|Participant Flow|Placebo/Gemcitabine/Erlotinib|Patients randomized to receive placebo + gemcitabine + erlotinib.
1043446|NCT00709826|O1|Outcome|Apricoxib/Gemcitabine/Erlotinib|Patients randomized to receive apricoxib + gemcitabine + erlotinib.
1043447|NCT00709826|O2|Outcome|Placebo/Gemcitabine/Erlotinib|Patients randomized to receive placebo + gemcitabine + erlotinib.
1043448|NCT00709826|O1|Outcome|Apricoxib/Gemcitabine/Erlotinib|Patients randomized to receive apricoxib + gemcitabine + erlotinib.
1043449|NCT00709826|E2|Reported Event|Placebo/Gemcitabine/Erlotinib|Patients randomized to receive placebo + gemcitabine + erlotinib.
1043450|NCT00709826|E1|Reported Event|Apricoxib/Gemcitabine/Erlotinib|Patients randomized to receive apricoxib + gemcitabine + erlotinib.
1043451|NCT00708734|B1|Baseline|Functional Exercise Training|"functional exercise training~functional exercise training: twice weekly group sessions for 5 weeks"
1043452|NCT00708734|P1|Participant Flow|Arm 1|"functional exercise training~functional exercise training: twice weekly group sessions for 10 weeks This one year feasibility study had a planned sample of 35 subjects. Of the 94 subjects that were screened, 45 did not meet criteria, and 39 declined participation after screening. Of the ten subjects enrolled, three completed the intervention and follow up sessions. The remaining seven were unable to continue participation after enrollment due to a number or reasons including vertigo, moving out of state, total knee replacement after baseline, unable to contact, scheduling conflicts, and a fall with fracture, precluding weight-bearing exercise."
1043453|NCT00708734|O1|Outcome|Composite Measures of Gait and Balance|Measurement of gait and balance using standardized tools
1043454|NCT00708734|E1|Reported Event|Functional Exercise Training|"functional exercise training~functional exercise training: twice weekly group sessions for 10 weeks This one year feasibility study had a planned sample of 35 subjects. Of the 94 subjects that were screened, 45 did not meet criteria, and 39 declined participation after screening. Of the ten subjects enrolled, three completed the intervention and follow up sessions. The remaining seven were unable to continue participation after enrollment due to a number or reasons including vertigo, moving out of state, total knee replacement after baseline, unable to contact, scheduling conflicts, and a fall with fracture, precluding weight-bearing exercise."
1043455|NCT00708721|B1|Baseline|All Groups|
1043456|NCT00708721|P4|Participant Flow|Not Evaluable|
1043457|NCT00708721|P3|Participant Flow|Cohort 3: 1 mg/Day for 7 Days|1 mg/day for 7/28 days
1043458|NCT00708721|P2|Participant Flow|Cohort 2: 1 mg/Day for 10 Days|1 mg/day for 10/28 days and for cycle 1 and then 1 mg/day for 7/28 days for cycle 2 onward
1043459|NCT00708721|P1|Participant Flow|Cohort 1: 5 mg/Day for 10 Days|5 mg/day for 10 out of 28 days
1043460|NCT00708721|O1|Outcome|All Patients|All participants enrolled.
1043461|NCT00708721|O1|Outcome|All Patients|All participants enrolled.
1043462|NCT00708721|O1|Outcome|All Patients|All participants enrolled.
1043463|NCT00708721|O1|Outcome|All Evaluable Patients|All evaluable patients. Eleven patients were enrolled, but only nine were evaluable.
1043464|NCT00708721|O1|Outcome|All Evaluable Patients|Only nine of the eleven patients were evaluable for this outcome measure.
1043465|NCT00708721|O1|Outcome|All Evaluable Patients|"All participants enrolled.~Clofarabine: Clofarabine is a rationally designed, second generation purine nucleoside analogue. Clofarabine was designed as a hybrid molecule to overcome the limitations and incorporate the best qualities of both fludarabine (F-ara-A) and cladribine (2-CdA, CdA) both of which are currently approved by various regulatory authorities for treatment of hematologic malignancies."
1043466|NCT00708721|O4|Outcome|Not Evaluable|
1043467|NCT00708721|O3|Outcome|Cohort 3: 1 mg/Day for 7 Days|
1043468|NCT00708721|O2|Outcome|Cohort 2: 1 mg/Day for 10 Days|
1043469|NCT00708721|O1|Outcome|Cohort 1: 10 mg/Day for 10 Days|
1043470|NCT00708721|E1|Reported Event|All Groups|All patients who received study treatment.
1043471|NCT00708708|B1|Baseline|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043472|NCT00708708|P1|Participant Flow|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043473|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043474|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043527|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
1043528|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
1053940|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
1044466|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
1043475|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043476|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043477|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043478|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043479|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043480|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043481|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043482|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043483|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043484|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043485|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043486|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043529|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
1044459|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
1043487|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043488|NCT00708708|O2|Outcome|Participants With Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
1043489|NCT00708708|O1|Outcome|Participants Without Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who never experienced a drug-free interval during the entire observational period.
1043490|NCT00708708|O2|Outcome|Participants With Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
1043491|NCT00708708|O1|Outcome|Participants Without Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who never experienced a drug-free interval during the entire observational period.
1043492|NCT00708708|O2|Outcome|Participants With Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
1043493|NCT00708708|O1|Outcome|Participants Without Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who never experienced a drug-free interval during the entire observational period.
1043494|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043495|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043496|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043497|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043530|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
1043498|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043499|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043500|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043501|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043502|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043503|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043504|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043505|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043506|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043507|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043508|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043509|NCT00708708|O3|Outcome|Remaining Participants|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
1043531|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
1043510|NCT00708708|O2|Outcome|Participants With Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
1043511|NCT00708708|O1|Outcome|Participants Without Drug-Free Interval|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who never experienced a drug-free interval during the entire observational period.
1043512|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043513|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043514|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043515|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043516|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043517|NCT00708708|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043518|NCT00708708|E1|Reported Event|Etanercept|Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician’s discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
1043519|NCT00708682|B1|Baseline|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
1043520|NCT00708682|P1|Participant Flow|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
1043521|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
1043522|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
1043523|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
1043524|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
1043525|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
1043526|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
1043532|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
1043533|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
1043534|NCT00708682|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose)
1043535|NCT00708682|E3|Reported Event|Toddler Dose 13vPnC|"13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 12 months of age (toddler dose).~Other AEs (non-serious events): the number affected (n) for non-systematic (non-solicited) Other AEs n=50; systematic (solicited) Any Local Reaction n=73; systematic (solicited) Any Systemic Event n=96."
1043536|NCT00708682|E2|Reported Event|After the Infant Series 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age).
1043537|NCT00708682|E1|Reported Event|Infant Series 13vPnC|"13-valent pneumococcal conjugate vaccine (13vPnC) 0.5mL dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series).~Other Adverse Events (AEs) (non-serious events): the number affected (n) for non-systematic (non-solicited) Other Adverse Events n=79; systematic (solicited) Any Local Reaction n=154, 139, and 112 for Dose 1, 2,and 3 of infant series, respectively; systematic (solicited) Any Systemic Event n=182, 144, and 126 for Dose 1, 2,and 3 of infant series, respectively."
1043538|NCT00708643|B3|Baseline|Total|Total of all reporting groups
1043539|NCT00708643|B2|Baseline|Narafilcon A|Silicone hydrogel daily disposable contact lens
1043540|NCT00708643|B1|Baseline|Habitual Silicone Hydrogel|Habitual contact lens wear.
1043541|NCT00708643|P2|Participant Flow|Narafilcon A|Silicone hydrogel daily disposable contact lens
1043542|NCT00708643|P1|Participant Flow|Habitual Silicone Hydrogel|Habitual contact lens wear.
1043543|NCT00708643|O2|Outcome|Narafilcon A|Silicone hydrogel daily disposable contact lens
1043544|NCT00708643|O1|Outcome|Habitual Silicone Hydrogel|Habitual contact lens wear.
1043545|NCT00708643|O2|Outcome|Narafilcon A|Silicone hydrogel daily disposable contact lens
1043546|NCT00708643|O1|Outcome|Habitual Silicone Hydrogel|Habitual contact lens wear.
1043547|NCT00708643|O2|Outcome|Narafilcon A|Silicone hydrogel daily disposable contact lens
1043548|NCT00708643|O1|Outcome|Habitual Silicone Hydrogel|Habitual contact lens wear.
1043549|NCT00708643|O2|Outcome|Narafilcon A|Silicone hydrogel daily disposable contact lens
1043550|NCT00708643|O1|Outcome|Habitual Silicone Hydrogel|Habitual contact lens wear.
1043551|NCT00708643|O2|Outcome|Narafilcon A|Silicone hydrogel daily disposable contact lens
1043552|NCT00708643|O1|Outcome|Habitual Silicone Hydrogel|Habitual contact lens wear.
1043553|NCT00708643|O2|Outcome|Narafilcon A|Silicone hydrogel daily disposable contact lens
1043554|NCT00708643|O1|Outcome|Habitual Silicone Hydrogel|Habitual contact lens wear.
1043555|NCT00708643|E2|Reported Event|Narafilcon A|Silicone hydrogel daily disposable contact lens
1043556|NCT00708643|E1|Reported Event|Habitual Silicone Hydrogel|Habitual contact lens wear.
1043557|NCT00709761|B1|Baseline|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
1043558|NCT00709761|P1|Participant Flow|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
1043559|NCT00709761|O1|Outcome|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
1043560|NCT00709761|O1|Outcome|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
1043561|NCT00709761|O1|Outcome|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
1043562|NCT00709761|O1|Outcome|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
1043563|NCT00709761|O1|Outcome|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
1043564|NCT00709761|O1|Outcome|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
1043565|NCT00709761|E1|Reported Event|Lapatinib 1000 mg + Nab-Paclitaxel|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after a meal along with a Nab-paclitaxel infusion at a dose of 100 milligrams/meters squared (mg/ m^2) on Days 1, 8, and 15, and then every 28 days (q28), intravenously (IV) over 30 minutes weekly, in a 4 week cycle.
1043566|NCT00709735|B3|Baseline|Total|Total of all reporting groups
1053941|NCT00684307|E5|Reported Event|VKA INR 2-3|
1043567|NCT00709735|B2|Baseline|Reactivation Propranolol (RP)|0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a “script preparation” session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences.
1043568|NCT00709735|B1|Baseline|Non-Reactivation Propranolol (NRP)|0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a “script preparation” session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences.
1043569|NCT00709735|P2|Participant Flow|Reactivation Propranolol (RP)|0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a “script preparation” session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences.
1043570|NCT00709735|P1|Participant Flow|Non-Reactivation Propranolol (NRP)|0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a “script preparation” session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences.
1043571|NCT00709735|O2|Outcome|Reactivation Propranolol (RP)|0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a “script preparation” session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences.
1043572|NCT00709735|O1|Outcome|Non-Reactivation Propranolol (NRP)|0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a “script preparation” session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences.
1043573|NCT00709735|O2|Outcome|Reactivation Propranolol (RP)|0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a “script preparation” session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences.
1043574|NCT00709735|O1|Outcome|Non-Reactivation Propranolol (NRP)|0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a “script preparation” session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences.
1043575|NCT00709735|E2|Reported Event|Reactivation Propranolol (RP)|0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a “script preparation” session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences.
1043576|NCT00709735|E1|Reported Event|Non-Reactivation Propranolol (NRP)|0.67 mg/kg short-acting propranolol capsules then 1 mg/kg long-acting propranolol capsules 90 minutes later on Day 0 (non-reactivation) followed by 0.67 mg/kg short-acting placebo capsules then 1 mg/kg long-acting placebo capsules 90 minutes later on Day 2 (reactivation). All participants then underwent a “script preparation” session in which the investigator elicited five discrete personal memories, including two traumatic combat experiences.
1043577|NCT00709722|B1|Baseline|Deoxyspergualin|SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles
1043578|NCT00709722|P1|Participant Flow|Deoxyspergualin|SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles
1043579|NCT00709722|O1|Outcome|Deoxyspergualin|SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles
1043580|NCT00709722|O1|Outcome|Deoxyspergualin|SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles
1043581|NCT00709722|O1|Outcome|Deoxyspergualin|SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles
1043582|NCT00709722|E1|Reported Event|Deoxyspergualin|SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles
1043583|NCT00709618|B1|Baseline|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
1043584|NCT00709618|P1|Participant Flow|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 milligrams per meters squared [mg/m^2]) intravenously (IV) once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
1043585|NCT00709618|O1|Outcome|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
1043586|NCT00709618|O1|Outcome|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
1044460|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
1043587|NCT00709618|O1|Outcome|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
1043588|NCT00709618|O1|Outcome|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
1043589|NCT00709618|O1|Outcome|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
1043590|NCT00709618|O1|Outcome|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
1043591|NCT00709618|O1|Outcome|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
1043592|NCT00709618|E1|Reported Event|Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg|Participants received vinorelbine (20 mg/m^2) IV once weekly for 3 weeks (on Days 1, 8, and 15 of a 4-week cycle, followed by a rest week) plus oral lapatinib (1500 mg once daily). Participants received study treatment until disease progression or withdrawal.
1043593|NCT00709592|B3|Baseline|Total|Total of all reporting groups
1043594|NCT00709592|B2|Baseline|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
1043595|NCT00709592|B1|Baseline|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
1043596|NCT00709592|P2|Participant Flow|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
1043597|NCT00709592|P1|Participant Flow|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
1043598|NCT00709592|O2|Outcome|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
1043599|NCT00709592|O1|Outcome|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
1043600|NCT00709592|O2|Outcome|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
1043601|NCT00709592|O1|Outcome|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
1043602|NCT00709592|O2|Outcome|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
1043603|NCT00709592|O1|Outcome|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
1043604|NCT00709592|O2|Outcome|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
1043605|NCT00709592|O1|Outcome|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
1043606|NCT00709592|O2|Outcome|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
1043607|NCT00709592|O1|Outcome|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
1043608|NCT00709592|O2|Outcome|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
1043609|NCT00709592|O1|Outcome|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
1043610|NCT00709592|O2|Outcome|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
1043611|NCT00709592|O1|Outcome|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
1043612|NCT00709592|O2|Outcome|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
1043613|NCT00709592|O1|Outcome|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
1043614|NCT00709592|E2|Reported Event|B:Thymoglobulin: 2.5 mg/kg/Day|2.5 mg/kg/d thymoglobulin IV d-9 to d-7
1043615|NCT00709592|E1|Reported Event|A:Thymoglobulin: 1.7 mg/kg/Day|1.7 mg/kg/d thymoglobulin IV d-9 to -7
1043616|NCT00709319|B1|Baseline|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes with DME and vitreomacular traction based on investigator’s evaluation, visual acuity 20/63–20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator’s usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
1043617|NCT00709319|P1|Participant Flow|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator’s evaluation, visual acuity 20/63–20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator’s usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
1043618|NCT00709319|O1|Outcome|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator's evaluation, visual acuity 20/63-20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator's usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
1043619|NCT00709319|O1|Outcome|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator’s evaluation, visual acuity 20/63–20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator’s usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
1043620|NCT00709319|O1|Outcome|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator’s evaluation, visual acuity 20/63–20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator’s usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
1043621|NCT00709319|O1|Outcome|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator’s evaluation, visual acuity 20/63–20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator’s usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
1043622|NCT00709319|O1|Outcome|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator's evaluation, visual acuity 20/63-20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator's usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
1043623|NCT00709319|E1|Reported Event|Diabetic Macular Edema and Vitreomacular Traction|The primary cohort included 87 eyes with DME and vitreomacular traction based on investigator’s evaluation, visual acuity 20/63–20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator’s usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
1043624|NCT00709228|B1|Baseline|PegIntron Plus Rebetol|Those with chronic Hepatitis C infected with Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) and treated withPeg-Intron 1.5 μg/kg/week plus Rebetol (ribavirin) 800-1200 mg/day who achieved a negative HCV-RNA at Week 4 and at Week 24 (n = 170)
1043625|NCT00709228|P1|Participant Flow|PegIntron Plus Rebetol|Those with chronic Hepatitis C infected with Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) and treated withPeg-Intron 1.5 μg/kg/week plus Rebetol (ribavirin) 800-1200 mg/day who achieved a negative Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) at Week 4 and at Week 24
1043626|NCT00709228|O1|Outcome|PegIntron Plus Rebetol|Those with chronic Hepatitis C infected with Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) and treated withPeg-Intron 1.5 μg/kg/week plus Rebetol (ribavirin) 800-1200 mg/day who achieved a negative Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) at Week 4 and at Week 24
1043627|NCT00709228|E1|Reported Event|PegInton Plus Rebetol|
1043628|NCT00709124|B3|Baseline|Total|Total of all reporting groups
1043629|NCT00709124|B2|Baseline|Sham|"60 minute sham sessions every day for the duration of subjects ICU stay. No voltage will be applied to those receiving sham sessions.~Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
1043630|NCT00709124|B1|Baseline|NMES|"60 minute daily NMES sessions every day for the duration of subject's ICU stay.~Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay."
1043631|NCT00709124|P2|Participant Flow|Sham|"60 minute sham sessions every day for the duration of subjects ICU stay. No voltage will be applied to those receiving sham sessions.~Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
1043632|NCT00709124|P1|Participant Flow|NMES|"60 minute daily NMES sessions every day for the duration of subject's ICU stay.~Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay."
1043633|NCT00709124|O2|Outcome|Sham|"60 minute sham sessions every day for the duration of subjects ICU stay. No voltage will be applied to those receiving sham sessions.~Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
1043634|NCT00709124|O1|Outcome|NMES|"60 minute daily NMES sessions every day for the duration of subject's ICU stay.~Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay."
1043635|NCT00709124|E2|Reported Event|Sham|"60 minute sham sessions every day for the duration of subjects ICU stay. No voltage will be applied to those receiving sham sessions.~Sham: 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied."
1043636|NCT00709124|E1|Reported Event|NMES|"60 minute daily NMES sessions every day for the duration of subject's ICU stay.~Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA): 60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay."
1043637|NCT00709111|B1|Baseline|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043638|NCT00709111|P1|Participant Flow|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043639|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043640|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043641|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043642|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043643|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043644|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043645|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043646|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043647|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043648|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043649|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043650|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043651|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043652|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043653|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043654|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043655|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043656|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043657|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043658|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043659|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043660|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043661|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043662|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043663|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043664|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043665|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043666|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043667|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043668|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043669|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043670|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043671|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043672|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043673|NCT00709111|O1|Outcome|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043674|NCT00709111|E1|Reported Event|Maraviroc|Maraviroc (MVC) was taken for 24 weeks, in addition to the subject's current antiretroviral therapy (ART) drug regimen. At week 24, subjects discontinued MVC and were followed for an additional 24 weeks off MVC, but still on current ART drug regimen.
1043675|NCT00709098|B4|Baseline|Total|Total of all reporting groups
1043676|NCT00709098|B3|Baseline|Iloprost Power 15 (Open-label Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
1043677|NCT00709098|B2|Baseline|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
1043678|NCT00709098|B1|Baseline|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
1043679|NCT00709098|P3|Participant Flow|Iloprost Power 15 (Open-label Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
1043680|NCT00709098|P2|Participant Flow|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
1043681|NCT00709098|P1|Participant Flow|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
1043682|NCT00709098|O2|Outcome|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
1043683|NCT00709098|O1|Outcome|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 6 disc
1043684|NCT00709098|O3|Outcome|Iloprost Power 15 (Open-label Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
1043685|NCT00709098|O2|Outcome|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
1043686|NCT00709098|O1|Outcome|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
1043687|NCT00709098|O3|Outcome|Iloprost Power 15 (Open-label Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
1043688|NCT00709098|O2|Outcome|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
1043689|NCT00709098|O1|Outcome|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
1043690|NCT00709098|O3|Outcome|Iloprost Power 15 (Open-label Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
1043691|NCT00709098|O2|Outcome|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
1043692|NCT00709098|O1|Outcome|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
1043693|NCT00709098|O3|Outcome|Iloprost Power 15 (Open-label Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
1043694|NCT00709098|O2|Outcome|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
1043695|NCT00709098|O1|Outcome|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
1043696|NCT00709098|E3|Reported Event|Iloprost Power 15 (Open-label Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
1044461|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
1043697|NCT00709098|E2|Reported Event|Iloprost Power 15 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
1043698|NCT00709098|E1|Reported Event|Iloprost Power 6 (Double-blind Period)|The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
1043699|NCT00709059|B1|Baseline|PegIntron Plus Rebetol|Previously untreated patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6.
1043700|NCT00709059|P1|Participant Flow|PegIntron Plus Rebetol|Previously untreated patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6.
1043701|NCT00709059|O1|Outcome|PegIntron Plus Rebetol|Previously untreated patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6.
1043702|NCT00709059|E1|Reported Event|PegIntron Plus Rebetol|Previously untreated patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6.
1043703|NCT00708942|B6|Baseline|Total|Total of all reporting groups
1043704|NCT00708942|B5|Baseline|Arm 5: Placebo Ointment, no Illumination|
1043705|NCT00708942|B4|Baseline|Arm 4: HAL Ointment, LED Diode Illumination|
1043706|NCT00708942|B3|Baseline|Arm 3: No Intervention|
1043707|NCT00708942|B2|Baseline|Arm 2: Placebo Suppository, Laser Illumination|
1043708|NCT00708942|B1|Baseline|Arm 1: HAL Suppository, Laser Illumination|
1043709|NCT00708942|P5|Participant Flow|Arm 5: Placebo Ointment, no Illumination|
1043710|NCT00708942|P4|Participant Flow|Arm 4: HAL Ointment, LED Diode Illumination|
1043711|NCT00708942|P3|Participant Flow|Arm 3: No Intervention|
1043712|NCT00708942|P2|Participant Flow|Arm 2: Placebo Suppository, Laser Illumination|
1043713|NCT00708942|P1|Participant Flow|Arm 1: HAL Suppository, Laser Illumination|
1043714|NCT00708942|O5|Outcome|Arm 5: Placebo Ointment, no Illumination|
1043715|NCT00708942|O4|Outcome|Arm 4: HAL Ointment, LED Diode Illumination|
1043716|NCT00708942|O3|Outcome|Arm 3: No Intervention|
1043717|NCT00708942|O2|Outcome|Arm 2: Placebo Suppository, Laser Illumination|
1043718|NCT00708942|O1|Outcome|Arm 1: HAL Suppository, Laser Illumination|
1043719|NCT00708942|O5|Outcome|Arm 5: Placebo Ointment, no Illumination|
1043720|NCT00708942|O4|Outcome|Arm 4: HAL Ointment, LED Diode Illumination|
1043721|NCT00708942|O3|Outcome|Arm 3: No Intervention|
1043722|NCT00708942|O2|Outcome|Arm 2: Placebo Suppository, Laser Illumination|
1043723|NCT00708942|O1|Outcome|Arm 1: HAL Suppository, Laser Illumination|
1043724|NCT00708942|O5|Outcome|Arm 5: Placebo Ointment, no Illumination|
1043725|NCT00708942|O4|Outcome|Arm 4: HAL Ointment, LED Diode Illumination|
1043726|NCT00708942|O3|Outcome|Arm 3: No Intervention|
1043727|NCT00708942|O2|Outcome|Arm 2: Placebo Suppository, Laser Illumination|
1043728|NCT00708942|O1|Outcome|Arm 1: HAL Suppository, Laser Illumination|
1043729|NCT00708942|E5|Reported Event|Arm 5: Placebo Ointment, no Illumination|
1043730|NCT00708942|E4|Reported Event|Arm 4: HAL Ointment, LED Diode Illumination|
1043731|NCT00708942|E3|Reported Event|Arm 3: No Intervention|
1043732|NCT00708942|E2|Reported Event|Arm 2: Placebo Suppository, Laser Illumination|
1043733|NCT00708942|E1|Reported Event|Arm 1: HAL Suppository, Laser Illumination|
1043734|NCT00708877|B1|Baseline|Transplant|All patients enrolled in study.
1043735|NCT00708877|P1|Participant Flow|Transplant|All patients enrolled in study.
1043736|NCT00708877|O1|Outcome|Transplant|The cohort was comprised of patients who received neoadjuvant chemoradiation and transplantation.
1043737|NCT00708877|E1|Reported Event|Transplant|The cohort was comprised of patients who received neoadjuvant chemoradiation and transplantation.
1043738|NCT00708851|B1|Baseline|NB-UVB Alone|"One leg receives NB-UVB Alone: NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy: 3 light exposures / week~Opposite leg receives: LCD therapy 2 applications/day and NB-UVB Light Device (311-315 nm) NB-UVB Phototherapy 3 light exposures / week"
1043739|NCT00708851|P1|Participant Flow|NB-UVB and NB-UVB+LCD|"NB-UVB Alone: NB-UVB Light Device (311-315 nm) NB-UVB Phototherapy: 3 light exposures / week~NB-UVB+LCD: 2 applications of LCD/day + NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy 3 light exposures / week"
1043740|NCT00708851|O2|Outcome|LCD+NB-UVB|"LCD+NB-UVB~LCD Solution with NB-UVB Phototherapy: LCD Solution: 2 applications / day~NB-UVB Phototherapy: 3 light sessions / week"
1043741|NCT00708851|O1|Outcome|NB-UVB Alone|"NB-UVB Alone~NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy: 3 light exposures / week"
1043742|NCT00708851|O2|Outcome|LCD+NB-UVB|"LCD+NB-UVB~LCD Solution with NB-UVB Phototherapy: LCD Solution: 2 applications / day~NB-UVB Phototherapy: 3 light sessions / week"
1043743|NCT00708851|O1|Outcome|NB-UVB Alone|"NB-UVB Alone~NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy: 3 light exposures / week"
1043744|NCT00708851|E2|Reported Event|LCD+NB-UVB|"LCD+NB-UVB~LCD Solution with NB-UVB Phototherapy: LCD Solution: 2 applications / day~NB-UVB Phototherapy: 3 light sessions / week"
1043745|NCT00708851|E1|Reported Event|NB-UVB Alone|"NB-UVB Alone~NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy: 3 light exposures / week"
1043746|NCT00708526|B3|Baseline|Total|Total of all reporting groups
1043747|NCT00708526|B2|Baseline|Standard of Care|At the end of surgery, the minute ventilation and EtCO2 remained at normal levels. The Quick Emergence Device was not used.
1043748|NCT00708526|B1|Baseline|Quick Emergence Device (QED)|At the end of surgery, the Quick Emergence Device was placed between the endotracheal tube and the anesthesia breathing circuit. Minute ventilation was doubled and the end tidal carbon dioxide concentration (EtCO2) was elevated to approximately 48 mmHg.
1043749|NCT00708526|P2|Participant Flow|Standard of Care|At the end of surgery, the minute ventilation and EtCO2 remained at normal levels. The Quick Emergence Device was not used.
1043750|NCT00708526|P1|Participant Flow|Quick Emergence Device (QED)|At the end of surgery, the Quick Emergence Device was placed between the endotracheal tube and the anesthesia breathing circuit. Minute ventilation was doubled and the end tidal carbon dioxide concentration (EtCO2) was elevated to approximately 48 mmHg.
1043751|NCT00708526|O2|Outcome|Standard of Care|At the end of surgery, the minute ventilation and EtCO2 remained at normal levels. The Quick Emergence Device was not used.
1053942|NCT00684307|E4|Reported Event|AZD0837 200 mg bd|
1043752|NCT00708526|O1|Outcome|Quick Emergence Device (QED)|At the end of surgery, the Quick Emergence Device was placed between the endotracheal tube and the anesthesia breathing circuit. Minute ventilation was doubled and the end tidal carbon dioxide concentration (EtCO2) was elevated to approximately 48 mmHg.
1043753|NCT00708526|O2|Outcome|Standard of Care|At the end of surgery, the minute ventilation and EtCO2 remained at normal levels. The Quick Emergence Device was not used.
1043754|NCT00708526|O1|Outcome|Quick Emergence Device (QED)|At the end of surgery, the Quick Emergence Device was placed between the endotracheal tube and the anesthesia breathing circuit. Minute ventilation was doubled and the end tidal carbon dioxide concentration (EtCO2) was elevated to approximately 48 mmHg.
1043755|NCT00708526|E2|Reported Event|Standard of Care|At the end of surgery, the minute ventilation and EtCO2 remained at normal levels. The Quick Emergence Device was not used.
1043756|NCT00708526|E1|Reported Event|Quick Emergence Device (QED)|At the end of surgery, the Quick Emergence Device was placed between the endotracheal tube and the anesthesia breathing circuit. Minute ventilation was doubled and the end tidal carbon dioxide concentration (EtCO2) was elevated to approximately 48 mmHg.
1043757|NCT00708500|B4|Baseline|Total|Total of all reporting groups
1043758|NCT00708500|B3|Baseline|Boceprevir+PEG2b+RBV, x 44 Weeks|Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1043759|NCT00708500|B2|Baseline|Boceprevir+PEG2b+RBV, Response Guided Therapy|"Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.~PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:~36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.~48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion."
1043760|NCT00708500|B1|Baseline|Placebo+PEG2b+RBV, x 44 Weeks|Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1043761|NCT00708500|P3|Participant Flow|Boceprevir+PEG2b+RBV, x 44 Weeks|Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1043762|NCT00708500|P2|Participant Flow|Boceprevir+PEG2b+RBV, Response Guided Therapy|"Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.~PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:~36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.~48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion."
1043763|NCT00708500|P1|Participant Flow|Placebo+PEG2b+RBV, x 44 Weeks|Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1043764|NCT00708500|O3|Outcome|Boceprevir+PEG2b+RBV, x 44 Weeks|Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1043765|NCT00708500|O2|Outcome|Boceprevir+PEG2b+RBV, Response Guided Therapy|"Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.~PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:~36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.~48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion."
1043766|NCT00708500|O1|Outcome|Placebo+PEG2b+RBV, x 44 Weeks|Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1043767|NCT00708500|O3|Outcome|Boceprevir+PEG2b+RBV, x 44 Weeks|Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1043768|NCT00708500|O2|Outcome|Boceprevir+PEG2b+RBV, Response Guided Therapy|"Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.~PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:~36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.~48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion."
1043769|NCT00708500|O1|Outcome|Placebo+PEG2b+RBV, x 44 Weeks|Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1043770|NCT00708500|O3|Outcome|Boceprevir+PEG2b+RBV, x 44 Weeks|Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1043799|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
1043800|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
1043801|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma : Intravenous Infusion, dosage depending on baseline INR and body weight
1044465|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
1043771|NCT00708500|O2|Outcome|Boceprevir+PEG2b+RBV, Response Guided Therapy|"Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.~PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:~36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.~48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion."
1043772|NCT00708500|O1|Outcome|Placebo+PEG2b+RBV, x 44 Weeks|Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1043773|NCT00708500|O3|Outcome|Boceprevir+PEG2b+RBV, x 44 Weeks|Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1043774|NCT00708500|O2|Outcome|Boceprevir+PEG2b+RBV, Response Guided Therapy|"Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.~PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:~36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.~48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion."
1043775|NCT00708500|O1|Outcome|Placebo+PEG2b+RBV, x 44 Weeks|Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1043776|NCT00708500|E3|Reported Event|Boceprevir+PEG2b+RBV, x 44 Weeks|Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1043777|NCT00708500|E2|Reported Event|Boceprevir+PEG2b+RBV, Response Guided Therapy|"Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.~PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:~36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.~48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion."
1043778|NCT00708500|E1|Reported Event|Placebo+PEG2b+RBV, x 44 Weeks|Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1043779|NCT00708461|B3|Baseline|Total|Total of all reporting groups
1043780|NCT00708461|B2|Baseline|No-contact Control|No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites.
1043781|NCT00708461|B1|Baseline|Worksite Environmental Intervention|Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention
1043782|NCT00708461|P2|Participant Flow|No-contact Control|No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites.
1043783|NCT00708461|P1|Participant Flow|Worksite Environmental Intervention|Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention
1043784|NCT00708461|O2|Outcome|No-contact Control|No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites.
1043785|NCT00708461|O1|Outcome|Worksite Environmental Intervention|Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention
1043786|NCT00708461|E2|Reported Event|No-contact Control|No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites.
1043787|NCT00708461|E1|Reported Event|Worksite Environmental Intervention|Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention
1043788|NCT00708435|B3|Baseline|Total|Total of all reporting groups
1043789|NCT00708435|B2|Baseline|Fresh Frozen Plasma|Fresh frozen plasma : Intravenous Infusion, dosage depending on baseline INR and body weight
1043790|NCT00708435|B1|Baseline|Beriplex® P/N|Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
1043791|NCT00708435|P2|Participant Flow|Fresh Frozen Plasma|Fresh frozen plasma : Single intravenous infusion as required to treat acute major bleeding; dosage 10, 12, or 15 mL/kg depending on baseline INR and body weight.
1043792|NCT00708435|P1|Participant Flow|Beriplex® P/N|Beriplex® P/N : Single intravenous infusion as required to treat acute major bleeding; dosage 25, 35 or 50 units/kg depending on baseline INR, amount of coagulation factor IX and body weight.
1043793|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
1043794|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
1043795|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
1043796|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
1043797|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
1043798|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
1043802|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
1043803|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma : Intravenous Infusion, dosage depending on baseline INR and body weight
1043804|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
1043805|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma : Intravenous Infusion, dosage depending on baseline INR and body weight
1043806|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
1043807|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
1043808|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
1043809|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
1043810|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
1043811|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
1043812|NCT00708435|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight
1043813|NCT00708435|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
1043814|NCT00708435|E2|Reported Event|Fresh Frozen Plasma|Fresh frozen plasma : Intravenous Infusion, dosage depending on baseline INR and body weight
1043815|NCT00708435|E1|Reported Event|Beriplex® P/N|Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
1043816|NCT00708422|B3|Baseline|Total|Total of all reporting groups
1043817|NCT00708422|B2|Baseline|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
1043818|NCT00708422|B1|Baseline|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
1043819|NCT00708422|P2|Participant Flow|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
1043820|NCT00708422|P1|Participant Flow|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
1043821|NCT00708422|O2|Outcome|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
1043822|NCT00708422|O1|Outcome|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
1043823|NCT00708422|O2|Outcome|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
1043824|NCT00708422|O1|Outcome|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
1043825|NCT00708422|E2|Reported Event|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
1043826|NCT00708422|E1|Reported Event|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
1043827|NCT00708305|B1|Baseline|Overall Study|All randomized participants
1043828|NCT00708305|P4|Participant Flow|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6 g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
1043829|NCT00708305|P3|Participant Flow|Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6 g NaMFP and NaF toothpaste (1450 ppm F – 1000 ppm F as NaMFP and 450 ppm F as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
1043830|NCT00708305|P2|Participant Flow|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6 g NaF toothpaste (1400 ppm F as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
1043831|NCT00708305|P1|Participant Flow|Sodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F)|Participants brushed their natural teeth for one timed minute with 1.6 grams (g) of with NaF and 0.4% carbopol toothpaste (1450 ppm F as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
1043832|NCT00708305|O4|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
1043833|NCT00708305|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
1043834|NCT00708305|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
1043835|NCT00708305|O1|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds
1043836|NCT00708305|O4|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
1043889|NCT00708214|O1|Outcome|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1053943|NCT00684307|E3|Reported Event|AZD0837 450 mg od|
1043837|NCT00708305|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
1043838|NCT00708305|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
1043839|NCT00708305|O1|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
1043840|NCT00708305|O4|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
1043841|NCT00708305|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
1043842|NCT00708305|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
1043843|NCT00708305|O1|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
1043844|NCT00708305|O4|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
1043845|NCT00708305|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
1043846|NCT00708305|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
1043847|NCT00708305|O1|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
1043848|NCT00708305|O4|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
1043849|NCT00708305|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
1043850|NCT00708305|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
1043851|NCT00708305|O1|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
1043852|NCT00708305|O4|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
1043853|NCT00708305|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
1043854|NCT00708305|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
1043855|NCT00708305|O1|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
1043856|NCT00708305|O2|Outcome|NaF Toothpaste (1400 Ppm F)|Participants brushed their natural teeth for one timed minute with 1.6 g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
1043857|NCT00708305|O1|Outcome|NaF Toothpaste(1450 Ppm F)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
1043890|NCT00708214|O3|Outcome|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043858|NCT00708305|E4|Reported Event|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g fluoride free toothpaste (0ppmF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
1043859|NCT00708305|E3|Reported Event|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
1043860|NCT00708305|E2|Reported Event|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g NaF toothpaste (1400ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
1043861|NCT00708305|E1|Reported Event|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with 1.6g of with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), under the supervision of study staff. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
1043862|NCT00708214|B4|Baseline|Total|Total of all reporting groups
1043863|NCT00708214|B3|Baseline|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043864|NCT00708214|B2|Baseline|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043865|NCT00708214|B1|Baseline|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043866|NCT00708214|P3|Participant Flow|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043867|NCT00708214|P2|Participant Flow|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043868|NCT00708214|P1|Participant Flow|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043869|NCT00708214|O1|Outcome|Afatinib Overall|Patients received continuous daily dosing with Afatinib 30, 40 or 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043870|NCT00708214|O1|Outcome|Afatinib Overall|Patients received continuous daily dosing with Afatinib 30, 40 or 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043871|NCT00708214|O1|Outcome|Afatinib Overall, With Letrozole 2.5mg|Patients received continuous daily dosing with Afatinib 30, 40 or 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043872|NCT00708214|O1|Outcome|Afatinib Overall, With Letrozole 2.5mg|Patients received continuous daily dosing with Afatinib 30, 40 or 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043873|NCT00708214|O1|Outcome|Afatinib Overall, With Letrozole 2.5 mg|Patients received continuous daily dosing with Afatinib 30, 40 or 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043874|NCT00708214|O2|Outcome|Afatinib 30 mg|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043875|NCT00708214|O1|Outcome|Afatinib 40 mg|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043876|NCT00708214|O2|Outcome|Afatinib 30 mg|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043877|NCT00708214|O1|Outcome|Afatinib 40 mg|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043878|NCT00708214|O2|Outcome|Afatinib 30 mg|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043879|NCT00708214|O1|Outcome|Afatinib 40 mg|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043880|NCT00708214|O2|Outcome|Afatinib 30 mg|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043881|NCT00708214|O1|Outcome|Afatinib 40 mg|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043882|NCT00708214|O2|Outcome|Afatinib 30 mg|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043883|NCT00708214|O1|Outcome|Afatinib 40 mg|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043884|NCT00708214|O3|Outcome|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043885|NCT00708214|O2|Outcome|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043886|NCT00708214|O1|Outcome|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043887|NCT00708214|O3|Outcome|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043888|NCT00708214|O2|Outcome|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1053944|NCT00684307|E2|Reported Event|AZD0837 300 mg od|
1043891|NCT00708214|O2|Outcome|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043892|NCT00708214|O1|Outcome|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043893|NCT00708214|O3|Outcome|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043894|NCT00708214|O2|Outcome|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043895|NCT00708214|O1|Outcome|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043896|NCT00708214|O3|Outcome|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043897|NCT00708214|O2|Outcome|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043898|NCT00708214|O1|Outcome|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043899|NCT00708214|O3|Outcome|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043900|NCT00708214|O2|Outcome|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043901|NCT00708214|O1|Outcome|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043902|NCT00708214|O3|Outcome|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043903|NCT00708214|O2|Outcome|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043904|NCT00708214|O1|Outcome|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043905|NCT00708214|E3|Reported Event|Afatinib 30 mg With Letrozole|Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043906|NCT00708214|E2|Reported Event|Afatinib 40 mg With Letrozole|Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043907|NCT00708214|E1|Reported Event|Afatinib 50 mg With Letrozole|Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
1043908|NCT00708201|B3|Baseline|Total|Total of all reporting groups
1043909|NCT00708201|B2|Baseline|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
1043910|NCT00708201|B1|Baseline|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
1043911|NCT00708201|P2|Participant Flow|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
1043912|NCT00708201|P1|Participant Flow|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
1043913|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
1043914|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
1043915|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
1043916|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
1043917|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
1043918|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
1043919|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
1043920|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
1043921|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
1043922|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
1043923|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
1043924|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
1043925|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
1043926|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
1043927|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
1043928|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
1043929|NCT00708201|O2|Outcome|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
1043930|NCT00708201|O1|Outcome|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
1043931|NCT00708201|E2|Reported Event|Alvimopan 12 mg|A single dose of alvimopan 12 milligrams (mg) was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
1043932|NCT00708201|E1|Reported Event|Placebo|A single dose of placebo was administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
1043933|NCT00708175|B3|Baseline|Total|Total of all reporting groups
1043934|NCT00708175|B2|Baseline|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
1043935|NCT00708175|B1|Baseline|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
1043936|NCT00708175|P2|Participant Flow|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
1043937|NCT00708175|P1|Participant Flow|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
1043938|NCT00708175|O2|Outcome|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
1043939|NCT00708175|O1|Outcome|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
1043940|NCT00708175|O2|Outcome|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
1043941|NCT00708175|O1|Outcome|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
1043942|NCT00708175|O2|Outcome|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
1043943|NCT00708175|O1|Outcome|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
1043944|NCT00708175|O2|Outcome|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
1043945|NCT00708175|O1|Outcome|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
1043946|NCT00708175|O2|Outcome|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
1043947|NCT00708175|O1|Outcome|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
1043948|NCT00708175|E2|Reported Event|Placebo|Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
1043949|NCT00708175|E1|Reported Event|Pioglitazone|Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.
1043950|NCT00708162|B3|Baseline|Total|Total of all reporting groups
1043951|NCT00708162|B2|Baseline|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1044033|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
1043952|NCT00708162|B1|Baseline|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043953|NCT00708162|P2|Participant Flow|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043954|NCT00708162|P1|Participant Flow|Elvitegravir|Elvitegravir (EVG) 85 or 150 mg tablet once daily plus raltegravir (RAL) placebo plus background regimen (1 fully-active ritonavir (RTV)-boosted protease inhibitor (PI) plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043955|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043956|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043957|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043958|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043959|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043960|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043961|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043962|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043963|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043964|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043965|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043966|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043967|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043968|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043969|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043970|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043971|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043972|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043973|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043974|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043975|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1053945|NCT00684307|E1|Reported Event|AZD0837 150 mg od|
1043976|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043977|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043978|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043979|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043980|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043981|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043982|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043983|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043984|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043985|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043986|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043987|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043988|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043989|NCT00708162|O2|Outcome|Raltegravir|RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043990|NCT00708162|O1|Outcome|Elvitegravir|EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
1043991|NCT00708162|E3|Reported Event|All Elvitegravir|Adverse events in this reporting group are those experienced by participants in the Elvitegravir group during both the Randomized Phase and Open-Label Phase, and those experienced by participants in the Raltegravir group following switch to EVG in the Open-Label Phase only.
1043992|NCT00708162|E2|Reported Event|Raltegravir|"Adverse events in this reporting group are those experienced by participants in the Raltegravir group during the Randomized Phase~RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase."
1043993|NCT00708162|E1|Reported Event|Elvitegravir|"Adverse events in this reporting group are those experienced by participants in the Elvitegravir group during the Randomized Phase~EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase."
1043994|NCT00708123|B1|Baseline|All Study Participants|All randomized participants were included for baseline evaluation.
1043995|NCT00708123|P5|Participant Flow|Placebo Toothpaste (0 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.
1043996|NCT00708123|P4|Participant Flow|NaF Toothpaste (250 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
1043997|NCT00708123|P3|Participant Flow|NaMFP/NaF Toothpaste (1450 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F – 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
1043998|NCT00708123|P2|Participant Flow|NaF/Carbopol Toothpaste (1400 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1400 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
1043999|NCT00708123|P1|Participant Flow|Sodium Fluoride (NaF) Toothpaste[1350 Parts Per Million(Ppm)F]|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
1044462|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
1044000|NCT00708123|O5|Outcome|Placebo Toothpaste (0 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.
1044001|NCT00708123|O4|Outcome|NaMFP/NaF Toothpaste (1450 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F – 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
1044002|NCT00708123|O3|Outcome|NaF Toothpaste (250 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
1044003|NCT00708123|O2|Outcome|NaF Toothpaste (1350ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
1044004|NCT00708123|O1|Outcome|NaF/ Carbopol Toothpaste (1400 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1400 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
1044005|NCT00708123|O5|Outcome|Placebo Toothpaste (0 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.
1044006|NCT00708123|O4|Outcome|NaMFP/NaF Toothpaste (1450 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F – 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
1044007|NCT00708123|O3|Outcome|NaF Toothpaste (250 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
1044008|NCT00708123|O2|Outcome|NaF Toothpaste (1350ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
1044009|NCT00708123|O1|Outcome|NaF/Carbopol Toothpaste (1400 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
1044010|NCT00708123|O3|Outcome|NaMFP/NaF Toothpaste (1450 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F – 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial dentures from their mouth.
1044011|NCT00708123|O2|Outcome|NaF Toothpaste (1350 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
1044012|NCT00708123|O1|Outcome|NaF/Carbopol Toothpaste (1400 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1400 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
1044013|NCT00708123|E5|Reported Event|Placebo Toothpaste (0 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.
1044014|NCT00708123|E4|Reported Event|NaF Toothpaste (250 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
1044015|NCT00708123|E3|Reported Event|NaMFP/NaF Toothpaste (1450 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F – 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
1044016|NCT00708123|E2|Reported Event|NaF Toothpaste (1350ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
1044017|NCT00708123|E1|Reported Event|NaF/ Carbopol Toothpaste (1400 Ppm F)|Participants brushed their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1400 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
1044018|NCT00708110|B5|Baseline|Total|Total of all reporting groups
1044019|NCT00708110|B4|Baseline|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044020|NCT00708110|B3|Baseline|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044021|NCT00708110|B2|Baseline|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
1044022|NCT00708110|B1|Baseline|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
1044023|NCT00708110|P4|Participant Flow|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044024|NCT00708110|P3|Participant Flow|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044025|NCT00708110|P2|Participant Flow|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
1044026|NCT00708110|P1|Participant Flow|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
1044027|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044028|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044029|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
1044030|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
1044031|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044032|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044034|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
1044035|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044036|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044037|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
1044038|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
1044039|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044040|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044041|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
1044042|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
1044043|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044044|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044045|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
1044046|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
1044047|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044048|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044049|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
1044050|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
1044051|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044052|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044053|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
1044054|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
1044055|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044056|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044057|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
1044058|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
1044059|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044060|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044061|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
1044062|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
1044063|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044064|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044065|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
1044066|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
1044067|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044068|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044069|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
1044070|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
1044071|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044072|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044073|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
1044074|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
1044075|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044076|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044077|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
1044078|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
1044079|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044080|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044081|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
1044082|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
1044083|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044084|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044085|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
1044086|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
1044087|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044088|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044089|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
1044090|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
1044091|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044092|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044093|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
1044094|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
1044095|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044096|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044097|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
1044098|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
1044099|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044100|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044101|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
1044102|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
1044103|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044104|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044105|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
1044106|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
1044107|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044108|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044109|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
1044110|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
1044111|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044112|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044113|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
1044114|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
1044115|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044116|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044117|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
1044118|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
1044463|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
1044119|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044120|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044121|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
1044122|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
1044123|NCT00708110|O4|Outcome|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044124|NCT00708110|O3|Outcome|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044125|NCT00708110|O2|Outcome|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
1044126|NCT00708110|O1|Outcome|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
1044127|NCT00708110|E4|Reported Event|GSK1349572 50 mg QD|Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044128|NCT00708110|E3|Reported Event|GSK1349572 10 mg QD|Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
1044129|NCT00708110|E2|Reported Event|GSK1349572 2 mg QD|Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
1044130|NCT00708110|E1|Reported Event|Placebo|Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
1044131|NCT00708097|B1|Baseline|All Randomized Participants|All randomized participants who received at least one of the treatment dentifrices during the study and had at least one safety assessment after using the treatment dentifrice.
1044132|NCT00708097|P5|Participant Flow|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with fluoride free toothpaste (0ppmF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
1044133|NCT00708097|P4|Participant Flow|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth for one timed minute with sodium fluoride and silica toothpaste (675ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
1044134|NCT00708097|P3|Participant Flow|Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
1044135|NCT00708097|P2|Participant Flow|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
1044136|NCT00708097|P1|Participant Flow|Sodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F)|Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 milliliters (mL) water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
1044137|NCT00708097|O5|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with fluoride free toothpaste (0ppmF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
1044138|NCT00708097|O4|Outcome|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth for one timed minute with sodium fluoride and silica toothpaste (675ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
1044139|NCT00708097|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
1044140|NCT00708097|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
1044141|NCT00708097|O1|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
1044142|NCT00708097|O5|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with fluoride free toothpaste (0ppmF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
1044210|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
1044143|NCT00708097|O4|Outcome|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth for one timed minute with sodium fluoride and silica toothpaste (675ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
1044144|NCT00708097|O3|Outcome|NaMFP/ NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
1044145|NCT00708097|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
1044146|NCT00708097|O1|Outcome|NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
1044147|NCT00708097|O5|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with fluoride free toothpaste (0ppmF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
1044148|NCT00708097|O4|Outcome|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth for one timed minute with sodium fluoride and silica toothpaste (675ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
1044149|NCT00708097|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
1044150|NCT00708097|O2|Outcome|NaF Toothpaste(1400ppmF)|Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
1044151|NCT00708097|O1|Outcome|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
1044152|NCT00708097|O5|Outcome|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with fluoride free toothpaste (0ppmF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
1044153|NCT00708097|O4|Outcome|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth for one timed minute with sodium fluoride and silica toothpaste (675ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
1044154|NCT00708097|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
1044155|NCT00708097|O2|Outcome|NaF Toothpaste(1400ppmF)|Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
1044156|NCT00708097|O1|Outcome|NaF/Carbopol Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
1044157|NCT00708097|O2|Outcome|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
1044158|NCT00708097|O1|Outcome|NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
1044159|NCT00708097|E6|Reported Event|Overall|All participants received all treatments during the study
1044211|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
1044212|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
1044160|NCT00708097|E5|Reported Event|Placebo Toothpaste (0ppmF)|Participants brushed their natural teeth for one timed minute with fluoride free toothpaste (0ppmF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
1044161|NCT00708097|E4|Reported Event|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth for one timed minute with sodium fluoride and silica toothpaste (675ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
1044162|NCT00708097|E3|Reported Event|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth for one timed minute with NaMFP and NaF toothpaste (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
1044163|NCT00708097|E2|Reported Event|NaF Toothpaste (1400ppmF)|Participants brushed their natural teeth for one timed minute with NaF toothpaste (1400ppmF as NaF), followed by rinsing with 10mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
1044164|NCT00708097|E1|Reported Event|NaF Toothpaste(1450ppmF)|Participants brushed their natural teeth for one timed minute with NaF and 0.4% carbopol toothpaste (1450ppmF as NaF), followed by rinsing with 10 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days. During the treatment period, participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
1044165|NCT00708071|B1|Baseline|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
1044166|NCT00708071|P1|Participant Flow|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
1044167|NCT00708071|O1|Outcome|Facelift Participants|
1044168|NCT00708071|O3|Outcome|SoC Looks Better|
1044169|NCT00708071|O2|Outcome|FS VH S/D 4 Looks Better|
1044170|NCT00708071|O1|Outcome|No Difference|
1044171|NCT00708071|O1|Outcome|Facelift Participants|
1044172|NCT00708071|O1|Outcome|Facelift Participants|
1044173|NCT00708071|O8|Outcome|SoC - Day 14|
1044174|NCT00708071|O7|Outcome|FS VH S/D 4 - Day 14|
1044175|NCT00708071|O6|Outcome|SoC - Day 10|
1044176|NCT00708071|O5|Outcome|FS VH S/D 4 - Day 10|
1044177|NCT00708071|O4|Outcome|SoC - Day 7|
1044178|NCT00708071|O3|Outcome|FS VH S/D 4 - Day 7|
1044179|NCT00708071|O2|Outcome|SoC - Day 3|
1044180|NCT00708071|O1|Outcome|FS VH S/D 4 - Day3|
1044181|NCT00708071|O4|Outcome|Participants With No Hematoma/Seroma on Either Side|
1044182|NCT00708071|O3|Outcome|Participants With Hematoma/Seroma on Both Sides|
1044183|NCT00708071|O2|Outcome|Participants With Hematoma/Seroma on SoC Side|
1044184|NCT00708071|O1|Outcome|Participants With Hematoma/Seroma on FS VH S/D 4 Side|
1044185|NCT00708071|O2|Outcome|FS VH S/D 4|
1044186|NCT00708071|O1|Outcome|Standard of Care (SoC)|
1044187|NCT00708071|O2|Outcome|FS VH S/D 4|
1044188|NCT00708071|O1|Outcome|Standard of Care (SoC)|
1044189|NCT00708071|O4|Outcome|Participants With No Resolution on Either Side|
1044190|NCT00708071|O3|Outcome|Participants With Complete Resolution on Both Sides|
1044191|NCT00708071|O2|Outcome|Complete Resolution of Edema With SoC But Not FS VH S/D 4|
1044192|NCT00708071|O1|Outcome|Complete Resolution of Edema With FS VH S/D 4 But Not SoC|
1044193|NCT00708071|O4|Outcome|Participants With No Resolution on Either Side|
1044194|NCT00708071|O3|Outcome|Participants With Complete Resolution on Both Sides|
1044195|NCT00708071|O2|Outcome|Complete Resolution of Ecchymosis With SoC But Not FS VH S/D 4|
1044196|NCT00708071|O1|Outcome|Complete Resolution of Ecchymosis With FS VH S/D 4 But Not SoC|
1044197|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
1044198|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
1044199|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
1044200|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
1044201|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
1044202|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
1044203|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
1044204|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
1044205|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
1044206|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
1044207|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
1044208|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
1044209|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
1044213|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
1044214|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
1044215|NCT00708071|O1|Outcome|Facelift Participants|One side of the face is treated with FS VH S/D 4; the other side of the face is treated using standard of care.
1044216|NCT00708071|O4|Outcome|Participants With No Ecchymosis on Either Side|
1044217|NCT00708071|O3|Outcome|Participants With Equal Ecchymosis On Both Sides|
1044218|NCT00708071|O2|Outcome|Participants With Less Ecchymosis Treated With SoC|
1044219|NCT00708071|O1|Outcome|Participants With Less Ecchymosis Treated With FS VH S/D 4|
1044220|NCT00708071|O4|Outcome|Participants With No Ecchymosis on Either Side|
1044221|NCT00708071|O3|Outcome|Participants With Equal Ecchymosis On Both Sides|
1044222|NCT00708071|O2|Outcome|Participants With Less Ecchymosis Treated With SoC|
1044223|NCT00708071|O1|Outcome|Participants With Less Ecchymosis Treated With FS VH S/D 4|
1044224|NCT00708071|O4|Outcome|Participants With No Ecchymosis on Either Side|
1044225|NCT00708071|O3|Outcome|Participants With Equal Ecchymosis On Both Sides|
1044226|NCT00708071|O2|Outcome|Participants With Less Ecchymosis Treated With SoC|
1044227|NCT00708071|O1|Outcome|Participants With Less Ecchymosis Treated With FS VH S/D 4|
1044228|NCT00708071|O4|Outcome|Participants With No Ecchymosis on Either Side|
1044229|NCT00708071|O3|Outcome|Participants With Equal Ecchymosis On Both Sides|
1044230|NCT00708071|O2|Outcome|Participants With Less Ecchymosis Treated With SoC|
1044231|NCT00708071|O1|Outcome|Participants With Less Ecchymosis Treated With FS VH S/D 4|
1044232|NCT00708071|O4|Outcome|Participants With No Ecchymosis on Either Side|
1044233|NCT00708071|O3|Outcome|Participants With Equal Ecchymosis On Both Sides|
1044234|NCT00708071|O2|Outcome|Participants With Less Ecchymosis Treated With SoC|
1044235|NCT00708071|O1|Outcome|Participants With Less Ecchymosis Treated With FS VH S/D 4|
1044236|NCT00708071|O4|Outcome|Participants With No Ecchymosis on Either Side|
1044237|NCT00708071|O3|Outcome|Participants With Equal Ecchymosis On Both Sides|
1044238|NCT00708071|O2|Outcome|Participants With Less Ecchymosis Treated With SoC|
1044239|NCT00708071|O1|Outcome|Participants With Less Ecchymosis Treated With FS VH S/D 4|
1044240|NCT00708071|E3|Reported Event|Non-localized AEs|AE affected a site other than either side of the face (ie, non-localized AE)
1044241|NCT00708071|E2|Reported Event|Localized to FS VH S/D 4 Side of Face|AE was localized to the side of the face which was treated with FS VH S/D 4.
1044242|NCT00708071|E1|Reported Event|Localized to SoC Side of Face|AE was localized to the side of the face which was treated with standard of care.
1044243|NCT00708032|B3|Baseline|Total|Total of all reporting groups
1044244|NCT00708032|B2|Baseline|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
1044245|NCT00708032|B1|Baseline|Spectacles|spectacles worn daily for 12 months
1044246|NCT00708032|P2|Participant Flow|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
1044247|NCT00708032|P1|Participant Flow|Spectacles|spectacles worn daily for 12 months
1044248|NCT00708032|O2|Outcome|Spectacles|habitual spectacles worn daily for 12 months
1044249|NCT00708032|O1|Outcome|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
1044250|NCT00708032|O2|Outcome|Spectacles|habitual spectacles worn daily for 12 months
1044251|NCT00708032|O1|Outcome|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
1044252|NCT00708032|O2|Outcome|Spectacles|habitual spectacles worn daily for 12 months
1044253|NCT00708032|O1|Outcome|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
1044254|NCT00708032|O2|Outcome|Spectacles|habitual spectacles worn daily for 12 months
1044255|NCT00708032|O1|Outcome|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
1044256|NCT00708032|O2|Outcome|Spectacles|habitual spectacles worn daily for 12 months
1044257|NCT00708032|O1|Outcome|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
1044258|NCT00708032|E2|Reported Event|Narafilcon A Lenses|narafilcon A soft contact lenses worn as daily disposable for 12 months
1044259|NCT00708032|E1|Reported Event|Spectacles|spectacles worn daily for 12 months
1044260|NCT00708019|B3|Baseline|Total|Total of all reporting groups
1044261|NCT00708019|B2|Baseline|High Dose|"High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
1044262|NCT00708019|B1|Baseline|Low Dose|"Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
1044464|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
1044263|NCT00708019|P2|Participant Flow|High Dose|"High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
1044264|NCT00708019|P1|Participant Flow|Low Dose|"Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
1044265|NCT00708019|O2|Outcome|High Dose|"High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
1044266|NCT00708019|O1|Outcome|Low Dose|"Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
1044267|NCT00708019|O2|Outcome|High Dose|"High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
1044268|NCT00708019|O1|Outcome|Low Dose|"Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
1044269|NCT00708019|E2|Reported Event|High Dose|"High dose of the psychoeducational intervention (i.e., 12.3 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
1044270|NCT00708019|E1|Reported Event|Low Dose|"Low dose of the psychoeducational intervention (i.e., 8.0 hours with the intervention nurse over 10 weeks)~PRO-SELF PLUS Pain Management Program: The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls [total time 12.3 hours]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls [8.0 hours]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes."
1044271|NCT00707993|B3|Baseline|Total|Total of all reporting groups
1044272|NCT00707993|B2|Baseline|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
1054433|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
1044273|NCT00707993|B1|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
1044274|NCT00707993|P2|Participant Flow|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
1044275|NCT00707993|P1|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
1044276|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
1044277|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
1044278|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
1044279|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
1044280|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
1044281|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
1044282|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
1044283|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
1044284|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
1044285|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
1044286|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
1044287|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
1044288|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
1044289|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
1044290|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
1044291|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
1044292|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
1044293|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
1044294|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
1044295|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
1044296|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
1044297|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
1044298|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
1044299|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
1044300|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
1044301|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
1044302|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
1044303|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
1044304|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
1044305|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
1044306|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
1044307|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
1044308|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
1044309|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
1044310|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
1044311|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
1044312|NCT00707993|O2|Outcome|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
1044313|NCT00707993|O1|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
1044314|NCT00707993|E2|Reported Event|Glipizide 5 mg QD|Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.
1044315|NCT00707993|E1|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.
1044316|NCT00707980|B1|Baseline|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
1044317|NCT00707980|P1|Participant Flow|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
1044318|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
1044319|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
1044320|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
1044321|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
1044322|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
1044323|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
1044324|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
1044325|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
1044326|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
1044327|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
1044328|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
1044329|NCT00707980|O1|Outcome|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
1044330|NCT00707980|E1|Reported Event|Vortioxetine|Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
1044331|NCT00707967|B4|Baseline|Total|Total of all reporting groups
1044332|NCT00707967|B3|Baseline|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044333|NCT00707967|B2|Baseline|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044334|NCT00707967|B1|Baseline|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044396|NCT00707954|B5|Baseline|Placebo|Placebo was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
1044335|NCT00707967|P3|Participant Flow|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044336|NCT00707967|P2|Participant Flow|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044337|NCT00707967|P1|Participant Flow|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044338|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044339|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044340|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044341|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044342|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044343|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044344|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044345|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044346|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044347|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044348|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044349|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044350|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044351|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044352|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044353|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044354|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044355|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044356|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044357|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044358|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044359|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044360|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044361|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044362|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044363|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044364|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044454|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
1044365|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044366|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044367|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044368|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044369|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044370|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044371|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044372|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044373|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044374|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044375|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044376|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044377|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044378|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044379|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044380|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044381|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044382|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044383|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044384|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044385|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044386|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044387|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044388|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044389|NCT00707967|O3|Outcome|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044390|NCT00707967|O2|Outcome|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044391|NCT00707967|O1|Outcome|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044392|NCT00707967|E3|Reported Event|Placebo Group|Subjects received 2 doses of saline solution, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044393|NCT00707967|E2|Reported Event|Control Group|Subjects received 2 doses of the GSK AS01E adjuvant, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044394|NCT00707967|E1|Reported Event|GSK692342 Group|Subjects received 2 doses of the GSK692342 vaccine, intramuscularly into the deltoid region of the non-dominant arm, at Day 0 and into the deltoid region of the dominant arm, at Day 30.
1044395|NCT00707954|B6|Baseline|Total|Total of all reporting groups
1054434|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
1044397|NCT00707954|B4|Baseline|TA-7284 400 mg|TA-7284 400 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
1044398|NCT00707954|B3|Baseline|TA-7284 200 mg|TA-7284 200 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
1044399|NCT00707954|B2|Baseline|TA-7284 100 mg|TA-7284 100 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
1044400|NCT00707954|B1|Baseline|TA-7284 25 mg|TA-7284 25 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
1044401|NCT00707954|P5|Participant Flow|Placebo|Placebo was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
1044402|NCT00707954|P4|Participant Flow|TA-7284 400 mg|TA-7284 400 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
1044403|NCT00707954|P3|Participant Flow|TA-7284 200 mg|TA-7284 200 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
1044404|NCT00707954|P2|Participant Flow|TA-7284 100 mg|TA-7284 100 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
1044405|NCT00707954|P1|Participant Flow|TA-7284 25 mg|TA-7284 25 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
1044406|NCT00707954|O5|Outcome|Placebo|Placebo was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
1044407|NCT00707954|O4|Outcome|TA-7284 400 mg|TA-7284 400 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
1044408|NCT00707954|O3|Outcome|TA-7284 200 mg|TA-7284 200 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
1044409|NCT00707954|O2|Outcome|TA-7284 100 mg|TA-7284 100 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
1044410|NCT00707954|O1|Outcome|TA-7284 25 mg|TA-7284 25 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
1044411|NCT00707954|E5|Reported Event|Placebo|Placebo was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
1044412|NCT00707954|E4|Reported Event|TA-7284 400 mg|TA-7284 400 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
1044413|NCT00707954|E3|Reported Event|TA-7284 200 mg|TA-7284 200 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
1044414|NCT00707954|E2|Reported Event|TA-7284 100 mg|TA-7284 100 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
1044415|NCT00707954|E1|Reported Event|TA-7284 25 mg|TA-7284 25 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
1044416|NCT00707915|B1|Baseline|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
1044417|NCT00707915|P1|Participant Flow|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
1044418|NCT00707915|O1|Outcome|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
1044419|NCT00707915|O1|Outcome|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
1044420|NCT00707915|O1|Outcome|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
1044421|NCT00707915|O1|Outcome|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
1044422|NCT00707915|O1|Outcome|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
1044423|NCT00707915|O1|Outcome|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
1044424|NCT00707915|E1|Reported Event|Dose-reduction|The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
1044425|NCT00707863|B3|Baseline|Total|Total of all reporting groups
1044426|NCT00707863|B2|Baseline|Depressed Subjects Age: 16 - 50 Yrs|"Subjects receiving Escitalopram (trade name: Lexapro) in the age range of 26-50~Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
1044427|NCT00707863|B1|Baseline|Depressed Subjects Age: 18 - 25 Yrs|"Subjects receiving Escitalopram (trade name: Lexapro) that are in the age range of 18-25~Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
1044428|NCT00707863|P2|Participant Flow|Depressed Subjects Age: 16 - 50 Yrs|"Subjects receiving Escitalopram (trade name: Lexapro) in the age range of 26-50~Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
1044429|NCT00707863|P1|Participant Flow|Depressed Subjects Age: 18 - 25 Yrs|"Subjects receiving Escitalopram (trade name: Lexapro) that are in the age range of 18-25~Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
1044430|NCT00707863|O2|Outcome|Depressed Subjects Age: 16 - 50 Yrs|"Subjects receiving Escitalopram (trade name: Lexapro) in the age range of 26-50~Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
1044431|NCT00707863|O1|Outcome|Depressed Subjects Age: 18 - 25 Yrs|"Subjects receiving Escitalopram (trade name: Lexapro) that are in the age range of 18-25~Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
1044432|NCT00707863|E2|Reported Event|Subjects Age: 26 - 50|"Subjects receiving Escitalopram (trade name: Lexapro) in the age range of 26-50~Escitalopram: 10 mg of Escitalopram by mouth per day for 8 weeks"
1044433|NCT00707863|E1|Reported Event|Subjects Age: 18 - 25|"Subjects receiving Escitalopram (trade name: Lexapro) that are in the age range of 18-25~Escitalopram: 10 mg of Escitalopram by mouth once a day for 8 weeks"
1044434|NCT00707759|B3|Baseline|Total|Total of all reporting groups
1044455|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
1044456|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
1044457|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
1044458|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
1044435|NCT00707759|B2|Baseline|B: Control Steroids|"Arms B: TAC + MMF + prednisolone (see schedule)/day~10°days after Tx: 2 mg/kg/d~Day 11 - 20: 1 mg/kg/d~Day 21 - 30: 0.5 mg/kg/d~Day 31 - 60: 0.3 mg/k/d~Week 8 - 12: 0.25 mg/k/d~Week 12 - 16: 0.20 mg/k/d~Week 16 - 20: 0.15 mg/k/d~Month 6 - 12: 0.10 - 0.12 mg/k/d~Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone: Arms B: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone (see schedule)/day~10°days after Tx: 2 mg/kg/d~Day 11 - 20: 1 mg/kg/d~Day 21 - 30: 0.5 mg/kg/d~Day 31 - 60: 0.3 mg/k/d~Week 8 - 12: 0.25 mg/k/d~Week 12 - 16: 0.20 mg/k/d~Week 16 - 20: 0.15 mg/k/d~Month 6 - 12: 0.10 - 0.12 mg/k/d"
1044436|NCT00707759|B1|Baseline|A: Withdrawal Steroids|"Arms A: TAC + MMF + withdrawal steroids over a six-days following randomization.~1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~3°day: Prednisone 2 mg/kg/d in 2 doses~4ºday: Prednisone 1 mg/kg/d in 2 doses~5ºday: Prednisone 0.5 mg/kg/d in 2 doses~6ºday: Prednisone 0.25 mg/kg/d in 2 doses~7ºday: Stop Prednisone~Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone: Arms A: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + withdrawal steroids over a six-days following randomization.~1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~3°day: Prednisone 2 mg/kg/d in 2 doses~4ºday: Prednisone 1 mg/kg/d in 2 doses~5ºday: Prednisone 0.5 mg/kg/d in 2 doses~6ºday: Prednisone 0.25 mg/kg/d in 2 doses~7ºday: Stop Prednisone"
1044437|NCT00707759|P2|Participant Flow|B: Control Steroids|"Arms B: TAC + MMF + prednisolone (see schedule)/day~10°days after Tx: 2 mg/kg/d~Day 11 - 20: 1 mg/kg/d~Day 21 - 30: 0.5 mg/kg/d~Day 31 - 60: 0.3 mg/k/d~Week 8 - 12: 0.25 mg/k/d~Week 12 - 16: 0.20 mg/k/d~Week 16 - 20: 0.15 mg/k/d~Month 6 - 12: 0.10 - 0.12 mg/k/d~Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone: Arms B: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone (see schedule)/day~10°days after Tx: 2 mg/kg/d~Day 11 - 20: 1 mg/kg/d~Day 21 - 30: 0.5 mg/kg/d~Day 31 - 60: 0.3 mg/k/d~Week 8 - 12: 0.25 mg/k/d~Week 12 - 16: 0.20 mg/k/d~Week 16 - 20: 0.15 mg/k/d~Month 6 - 12: 0.10 - 0.12 mg/k/d"
1044438|NCT00707759|P1|Participant Flow|A: Withdrawal Steroids|"Arms A: TAC + MMF + withdrawal steroids over a six-days following randomization.~1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~3°day: Prednisone 2 mg/kg/d in 2 doses~4ºday: Prednisone 1 mg/kg/d in 2 doses~5ºday: Prednisone 0.5 mg/kg/d in 2 doses~6ºday: Prednisone 0.25 mg/kg/d in 2 doses~7ºday: Stop Prednisone~Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone: Arms A: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + withdrawal steroids over a six-days following randomization.~1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~3°day: Prednisone 2 mg/kg/d in 2 doses~4ºday: Prednisone 1 mg/kg/d in 2 doses~5ºday: Prednisone 0.5 mg/kg/d in 2 doses~6ºday: Prednisone 0.25 mg/kg/d in 2 doses~7ºday: Stop Prednisone"
1044439|NCT00707759|O2|Outcome|B: Control Steroids|"Arms B: TAC + MMF + prednisolone (see schedule)/day~10°days after Tx: 2 mg/kg/d~Day 11 - 20: 1 mg/kg/d~Day 21 - 30: 0.5 mg/kg/d~Day 31 - 60: 0.3 mg/k/d~Week 8 - 12: 0.25 mg/k/d~Week 12 - 16: 0.20 mg/k/d~Week 16 - 20: 0.15 mg/k/d~Month 6 - 12: 0.10 - 0.12 mg/k/d~Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone: Arms B: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone (see schedule)/day~10°days after Tx: 2 mg/kg/d~Day 11 - 20: 1 mg/kg/d~Day 21 - 30: 0.5 mg/kg/d~Day 31 - 60: 0.3 mg/k/d~Week 8 - 12: 0.25 mg/k/d~Week 12 - 16: 0.20 mg/k/d~Week 16 - 20: 0.15 mg/k/d~Month 6 - 12: 0.10 - 0.12 mg/k/d"
1044440|NCT00707759|O1|Outcome|A: Withdrawal Steroids|"Arms A: TAC + MMF + withdrawal steroids over a six-days following randomization.~1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~3°day: Prednisone 2 mg/kg/d in 2 doses~4ºday: Prednisone 1 mg/kg/d in 2 doses~5ºday: Prednisone 0.5 mg/kg/d in 2 doses~6ºday: Prednisone 0.25 mg/kg/d in 2 doses~7ºday: Stop Prednisone~Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone: Arms A: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + withdrawal steroids over a six-days following randomization.~1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~3°day: Prednisone 2 mg/kg/d in 2 doses~4ºday: Prednisone 1 mg/kg/d in 2 doses~5ºday: Prednisone 0.5 mg/kg/d in 2 doses~6ºday: Prednisone 0.25 mg/kg/d in 2 doses~7ºday: Stop Prednisone"
1044441|NCT00707759|E2|Reported Event|B: Control Steroids|"Arms B: TAC + MMF + prednisolone (see schedule)/day~10°days after Tx: 2 mg/kg/d~Day 11 - 20: 1 mg/kg/d~Day 21 - 30: 0.5 mg/kg/d~Day 31 - 60: 0.3 mg/k/d~Week 8 - 12: 0.25 mg/k/d~Week 12 - 16: 0.20 mg/k/d~Week 16 - 20: 0.15 mg/k/d~Month 6 - 12: 0.10 - 0.12 mg/k/d~Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone: Arms B: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone (see schedule)/day~10°days after Tx: 2 mg/kg/d~Day 11 - 20: 1 mg/kg/d~Day 21 - 30: 0.5 mg/kg/d~Day 31 - 60: 0.3 mg/k/d~Week 8 - 12: 0.25 mg/k/d~Week 12 - 16: 0.20 mg/k/d~Week 16 - 20: 0.15 mg/k/d~Month 6 - 12: 0.10 - 0.12 mg/k/d"
1044442|NCT00707759|E1|Reported Event|A: Withdrawal Steroids|"Arms A: TAC + MMF + withdrawal steroids over a six-days following randomization.~1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~3°day: Prednisone 2 mg/kg/d in 2 doses~4ºday: Prednisone 1 mg/kg/d in 2 doses~5ºday: Prednisone 0.5 mg/kg/d in 2 doses~6ºday: Prednisone 0.25 mg/kg/d in 2 doses~7ºday: Stop Prednisone~Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone: Arms A: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + withdrawal steroids over a six-days following randomization.~1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses~3°day: Prednisone 2 mg/kg/d in 2 doses~4ºday: Prednisone 1 mg/kg/d in 2 doses~5ºday: Prednisone 0.5 mg/kg/d in 2 doses~6ºday: Prednisone 0.25 mg/kg/d in 2 doses~7ºday: Stop Prednisone"
1044443|NCT00707746|B3|Baseline|Total|Total of all reporting groups
1044444|NCT00707746|B2|Baseline|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
1044445|NCT00707746|B1|Baseline|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
1044446|NCT00707746|P2|Participant Flow|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
1044447|NCT00707746|P1|Participant Flow|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
1044448|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
1044449|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
1044450|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
1044451|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
1044452|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
1044453|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
1044467|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
1044468|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
1044469|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
1044470|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
1044471|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
1044472|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
1044473|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
1044474|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
1044475|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
1044476|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
1044477|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
1044478|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
1044479|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
1044480|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
1044481|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
1044482|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
1044483|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
1044484|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
1044485|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
1044486|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
1044487|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
1044488|NCT00707746|O2|Outcome|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
1044489|NCT00707746|O1|Outcome|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
1044490|NCT00707746|E2|Reported Event|Mipomersen|200 mg (1 mL) of mipomersen, weekly subcutaneous injections for 26 weeks
1044491|NCT00707746|E1|Reported Event|Placebo|1 mL placebo saline, weekly subcutaneous injections for 26 weeks
1044492|NCT00707655|B3|Baseline|Total|Total of all reporting groups
1044493|NCT00707655|B2|Baseline|Zalutumumab 8 mg/kg|8 weekly infusions
1044494|NCT00707655|B1|Baseline|Zalutumumab 4 mg/kg|8 weekly infusions
1044495|NCT00707655|P2|Participant Flow|Zalutumumab 8 mg/kg|8 weekly infusions
1044496|NCT00707655|P1|Participant Flow|Zalutumumab 4 mg/kg|8 weekly infusions
1044497|NCT00707655|O2|Outcome|Zalutumumab 8 mg/kg|8 weekly infusions
1044498|NCT00707655|O1|Outcome|Zalutumumab 4 mg/kg|8 weekly infusions
1044499|NCT00707655|O2|Outcome|Zalutumumab 8 mg/kg|8 weekly infusions
1044500|NCT00707655|O1|Outcome|Zalutumumab 4 mg/kg|8 weekly infusions
1044501|NCT00707655|O2|Outcome|Zalutumumab 8 mg/kg|
1044502|NCT00707655|O1|Outcome|Zalutumumab 4 mg/kg|
1044503|NCT00707655|E2|Reported Event|Zalutumumab 8 mg/kg|8 weekly infusions
1044504|NCT00707655|E1|Reported Event|Zalutumumab 4 mg/kg|8 weekly infusions
1044505|NCT00707577|B3|Baseline|Total|Total of all reporting groups
1044506|NCT00707577|B2|Baseline|Control|No maintenance program provided
1044507|NCT00707577|B1|Baseline|Internet-based Maintenance Program|"9-month Internet based self-monitoring maintenance program to track weight, exercise, and food logs~Internet-based maintenance program: The Be Fit maintenance program is a randomized controlled trial of a 9 month intervention to maintain weight loss and physical activity after completion of the 12 week wellness program. Six teams of 25 participants will be randomized to the intervention or to usual care. There are 2 key elements to the maintenance program: personal contact and Internet contact. The personal contact enables the participants to continue receiving face-to-face support from a Be Fit nutritionist and trainer. The Internet interface is an opportunity for the participants to self-monitor their own progress while still under the guidance of the program."
1044508|NCT00707577|P2|Participant Flow|Control|No maintenance program provided
1044509|NCT00707577|P1|Participant Flow|Internet-based Maintenance Program|"9-month Internet based self-monitoring maintenance program to track weight, exercise, and food logs~Internet-based maintenance program: The Be Fit maintenance program is a randomized controlled trial of a 9 month intervention to maintain weight loss and physical activity after completion of the 12 week wellness program. Six teams of 25 participants will be randomized to the intervention or to usual care. There are 2 key elements to the maintenance program: personal contact and Internet contact. The personal contact enables the participants to continue receiving face-to-face support from a Be Fit nutritionist and trainer. The Internet interface is an opportunity for the participants to self-monitor their own progress while still under the guidance of the program."
1044510|NCT00707577|O2|Outcome|Control|No maintenance program provided
1044511|NCT00707577|O1|Outcome|Internet-based Maintenance Program|"9-month Internet based self-monitoring maintenance program to track weight, exercise, and food logs~Internet-based maintenance program: The Be Fit maintenance program is a randomized controlled trial of a 9 month intervention to maintain weight loss and physical activity after completion of the 12 week wellness program. Six teams of 25 participants will be randomized to the intervention or to usual care. There are 2 key elements to the maintenance program: personal contact and Internet contact. The personal contact enables the participants to continue receiving face-to-face support from a Be Fit nutritionist and trainer. The Internet interface is an opportunity for the participants to self-monitor their own progress while still under the guidance of the program."
1044512|NCT00707577|E2|Reported Event|Control|No maintenance program provided
1044634|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
1044638|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
1044513|NCT00707577|E1|Reported Event|Internet-based Maintenance Program|"9-month Internet based self-monitoring maintenance program to track weight, exercise, and food logs~Internet-based maintenance program: The Be Fit maintenance program is a randomized controlled trial of a 9 month intervention to maintain weight loss and physical activity after completion of the 12 week wellness program. Six teams of 25 participants will be randomized to the intervention or to usual care. There are 2 key elements to the maintenance program: personal contact and Internet contact. The personal contact enables the participants to continue receiving face-to-face support from a Be Fit nutritionist and trainer. The Internet interface is an opportunity for the participants to self-monitor their own progress while still under the guidance of the program."
1044514|NCT00707486|B1|Baseline|Hemcon Dental Dressing and Gauze With Pressure|In the case of this study, participants served as their own control.
1044515|NCT00707486|P1|Participant Flow|Hemcon Dental Dressing With Pressure|Subjects served as their own control. Subject had both the HemCon Dental Dressing and one of two controls: Gelfoam or Gauze with pressure. Subjects had paired extractions; each extraction site within the pair were randomized to the HemCon Dental Dressing or to a control.
1044516|NCT00707486|O3|Outcome|Total|
1044517|NCT00707486|O2|Outcome|Control: Gauze|
1044518|NCT00707486|O1|Outcome|HemCon|Experimental
1044519|NCT00707486|O3|Outcome|Total|
1044520|NCT00707486|O2|Outcome|Control: Gauze|
1044521|NCT00707486|O1|Outcome|HemCon|Experimental
1044522|NCT00707486|E1|Reported Event|Hemcon Dental Dressing and Gauze With Pressure|In the case of this study, participants served as their own control.
1044523|NCT00707447|B3|Baseline|Total|Total of all reporting groups
1044524|NCT00707447|B2|Baseline|2/PREDIAS|Intervention consists of a group programme (PREDIAS) aiming at modification of lifestyle
1044525|NCT00707447|B1|Baseline|1/Control|Control group received written instruction about healthy eating and increasing physical exercise
1044526|NCT00707447|P2|Participant Flow|2/PREDIAS|Intervention consists of a group programme (PREDIAS) aiming at modification of lifestyle
1044527|NCT00707447|P1|Participant Flow|1/Control|Control group received written instruction about healthy eating and increasing physical exercise
1044528|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
1044529|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
1044530|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
1044531|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
1044532|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
1044533|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
1044534|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
1044535|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
1044536|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
1044537|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
1044538|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
1044539|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
1044540|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
1044541|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
1044542|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
1044543|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
1044544|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
1044545|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
1044546|NCT00707447|O2|Outcome|Control Group|Written information material about diabetes prevention by loosing weight, increasing physical activity
1044547|NCT00707447|O1|Outcome|Lifestyle Intervention Group (PREDIAS)|10 group sessions about healthy eating, modifying eating behavior, increasing physical activity and modifying risk factors for diabetes
1044548|NCT00707447|E2|Reported Event|2/PREDIAS|Intervention consists of a group programme (PRAEDIAS) aiming at modification of lifestyle
1044549|NCT00707447|E1|Reported Event|1/Control|Control group received written instruction about healthy eating and increasing physical exercise
1044550|NCT00707343|B1|Baseline|FLT-PET Imaging: [F-18] FLT|"All participants enrolled.~FLT-PET Imaging: radiopharmaceutical 3'-deoxy-3'-[F-18]fluorothymidine, [F-18]FLT, a radiopharmaceutical that directly assess tumor proliferation using Positron Emission Tomography(PET) in differentiating tumor recurrence from radiation necrosis in a group of patients with glial neoplasms."
1044551|NCT00707343|P1|Participant Flow|FLT-PET Imaging: [F-18] FLT|"All participants enrolled.~FLT-PET Imaging: radiopharmaceutical 3'-deoxy-3'-[F-18]fluorothymidine, [F-18]FLT, a radiopharmaceutical that directly assess tumor proliferation using Positron Emission Tomography(PET) in differentiating tumor recurrence from radiation necrosis in a group of patients with glial neoplasms."
1054435|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
1044552|NCT00707343|O1|Outcome|FLT-PET Imaging: [F-18] FLT|"All participants enrolled.~FLT-PET Imaging: radiopharmaceutical 3'-deoxy-3'-[F-18]fluorothymidine, [F-18]FLT, a radiopharmaceutical that directly assess tumor proliferation using Positron Emission Tomography(PET) in differentiating tumor recurrence from radiation necrosis in a group of patients with glial neoplasms."
1044553|NCT00707343|E1|Reported Event|FLT-PET Imaging: [F-18] FLT|"All participants enrolled.~FLT-PET Imaging: radiopharmaceutical 3'-deoxy-3'-[F-18]fluorothymidine, [F-18]FLT, a radiopharmaceutical that directly assess tumor proliferation using Positron Emission Tomography(PET) in differentiating tumor recurrence from radiation necrosis in a group of patients with glial neoplasms."
1044554|NCT00707239|B4|Baseline|Total|Total of all reporting groups
1044555|NCT00707239|B3|Baseline|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
1044556|NCT00707239|B2|Baseline|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
1044557|NCT00707239|B1|Baseline|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
1044558|NCT00707239|P3|Participant Flow|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
1044559|NCT00707239|P2|Participant Flow|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
1044560|NCT00707239|P1|Participant Flow|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
1044561|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
1044562|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
1044563|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
1044564|NCT00707239|O1|Outcome|Tigecycline or Imipenem/Cilastatin|Tigecycline 150 or 200 mg loading dose intravenously followed by tigecycline 75 or 100 mg maintenance dose intravenously approximately every 12 hrs or imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Ceftazidime 2 gram or matching placebo intravenously approximately every 8 hrs, an aminoglycoside, either tobramycin 7 mg/kg daily or amikacin 20 mg/kg daily, and vancomycin 15 mg/kg or matching placebo intravenously every 12 hrs at the start of therapy unless it was known at baseline that the participant did not have P. aeruginosa or MRSA.
1044565|NCT00707239|O1|Outcome|Tigecycline or Imipenem/Cilastatin|Tigecycline 150 or 200 mg loading dose intravenously followed by tigecycline 75 or 100 mg maintenance dose intravenously approximately every 12 hrs or imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Ceftazidime 2 gram or matching placebo intravenously approximately every 8 hrs, an aminoglycoside, either tobramycin 7 mg/kg daily or amikacin 20 mg/kg daily, and vancomycin 15 mg/kg or matching placebo intravenously at the start of therapy unless it was known at baseline that the participant did not have P. aeruginosa or MRSA.
1044566|NCT00707239|O1|Outcome|Tigecycline|Tigecycline 150 or 200 mg loading dose intravenously followed by tigecycline 75 or 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless the participant did not have P. aeruginosa or MRSA.
1044567|NCT00707239|O1|Outcome|Tigecycline|Tigecycline 150 or 200 mg loading dose intravenously followed by tigecycline 75 or 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless the participant did not have P. aeruginosa or MRSA.
1044568|NCT00707239|O1|Outcome|Tigecycline|Tigecycline 150 or 200 mg loading dose intravenously followed by tigecycline 75 or 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless the participant did not have P. aeruginosa or MRSA.
1044635|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
1054436|NCT00683618|O2|Outcome|Atorvastatin 10mg|Taken orally once daily
1044569|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
1044570|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
1044571|NCT00707239|O1|Outcome|Tigecycline|Tigecycline 150 or 200 mg loading dose intravenously followed by tigecycline 75 or 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless the participant did not have P. aeruginosa or MRSA.
1044572|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
1044573|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
1044574|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
1044575|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
1044576|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
1044577|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
1044578|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
1044579|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
1044580|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
1044581|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
1044582|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
1044583|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
1044584|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
1044636|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
1044637|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
1044585|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
1044586|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
1044587|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
1044588|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
1044589|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
1044590|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
1044591|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
1044592|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
1044593|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
1044594|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
1044595|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
1044596|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
1044597|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
1044598|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
1044599|NCT00707239|O3|Outcome|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
1044600|NCT00707239|O2|Outcome|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
1044601|NCT00707239|O1|Outcome|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
1044602|NCT00707239|E3|Reported Event|Imipenem/Cilastatin 1 Gram|Imipenem/cilastatin 1 gram intravenously approximately every 8 hrs. Vancomycin 15 mg/kg intravenously approximately every 12 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and ceftazidime placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
1044603|NCT00707239|E2|Reported Event|Tigecycline 100 mg|Tigecycline 200 mg loading dose intravenously followed by tigecycline 100 mg maintenance dose intravenously approximately every 12 hrs. Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kg or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have P. aeruginosa or MRSA.
1044604|NCT00707239|E1|Reported Event|Tigecycline 75 mg|Tigecycline 150 milligram (mg) loading dose intravenously followed by tigecycline 75 mg maintenance dose intravenously approximately every 12 hours (hrs). Ceftazidime 2 gram intravenously approximately every 8 hrs, an aminoglycoside (tobramycin 7 mg/kilogram [mg/kg] or amikacin 20 mg/kg daily) and vancomycin placebo intravenously at the start of therapy unless participant did not have Pseudomonas aeruginosa (P. aeruginosa) or methicillin-resistant Staphylococcus aureus (MRSA).
1044605|NCT00707174|B3|Baseline|Total|Total of all reporting groups
1044606|NCT00707174|B2|Baseline|Imiquimod and Tazarotene Combined|"Topical imiquimod and topical tazarotene 0.1% cream group:~Patients randomized to this group will undergo an identical treatment protocol as the topical imiquimod group with the addition of topical tazarotene 0.1% cream on Saturday and Sunday of each week."
1044607|NCT00707174|B1|Baseline|Imiquimod Only|"Topical imiquimod group:~treat the LM site two centimeters beyond the perimeter margin with topical imiquimod 5% cream Monday thru Friday of each week for a total of twelve weeks. After three months of topical treatment, a one-month wash out period will be observed to allow for resolution of inflammation that can obscure the pathologist’s ability to evaluate the excised tumor/treatment site."
1044608|NCT00707174|P2|Participant Flow|Imiquimod and Tazarotene Combined|"Topical imiquimod and topical tazarotene 0.1% cream group:~Patients randomized to this group will undergo an identical treatment protocol as the topical imiquimod group with the addition of topical tazarotene 0.1% cream on Saturday and Sunday of each week."
1044609|NCT00707174|P1|Participant Flow|Imiquimod Only|"Topical imiquimod group:~treat the LM site two centimeters beyond the perimeter margin with topical imiquimod 5% cream Monday thru Friday of each week for a total of twelve weeks. After three months of topical treatment, a one-month wash out period will be observed to allow for resolution of inflammation that can obscure the pathologist's ability to evaluate the excised tumor/treatment site."
1044610|NCT00707174|O2|Outcome|Imiquimod and Tazarotene Combined|"Topical imiquimod and topical tazarotene 0.1% cream group:~Patients randomized to this group will undergo an identical treatment protocol as the topical imiquimod group with the addition of topical tazarotene 0.1% cream on Saturday and Sunday of each week."
1044611|NCT00707174|O1|Outcome|Imiquimod Only|"Topical imiquimod group:~treat the LM site two centimeters beyond the perimeter margin with topical imiquimod 5% cream Monday thru Friday of each week for a total of twelve weeks. After three months of topical treatment, a one-month wash out period will be observed to allow for resolution of inflammation that can obscure the pathologist's ability to evaluate the excised tumor/treatment site."
1044612|NCT00707174|E2|Reported Event|Imiquimod and Tazarotene Combined|"Topical imiquimod and topical tazarotene 0.1% cream group:~Patients randomized to this group will undergo an identical treatment protocol as the topical imiquimod group with the addition of topical tazarotene 0.1% cream on Saturday and Sunday of each week."
1044613|NCT00707174|E1|Reported Event|Imiquimod Only|"Topical imiquimod group:~treat the LM site two centimeters beyond the perimeter margin with topical imiquimod 5% cream Monday thru Friday of each week for a total of twelve weeks. After three months of topical treatment, a one-month wash out period will be observed to allow for resolution of inflammation that can obscure the pathologist’s ability to evaluate the excised tumor/treatment site."
1044614|NCT00707161|B1|Baseline|Treatment Arm (Radiation Therapy & Cisplatin)|Radiation therapy given at 50 Gy, 20 fractions, for 4 weeks (2.5 Gy/day). Cisplatin given at 100mg/m2 i.v. every 3 weeks for a total of 2 doses (days 1 and 22) during radiation.
1044615|NCT00707161|P1|Participant Flow|Treatment Arm (Radiation Therapy & Cisplatin)|All patients will receive Radiation Therapy and Cisplatin for their melanoma. If appropriate patients will have surgical resection for residual or recurrent melanoma following chemoradiation.
1044616|NCT00707161|O1|Outcome|Treatment Arm (Radiation & Cisplatin)|Group of participants receiving Radiation and Cisplatin.
1044617|NCT00707161|E1|Reported Event|Treatment Arm (Radiation Therapy & Cisplatin)|Radiation therapy given at 50 Gy, 20 fractions, for 4 weeks (2.5 Gy/day). Cisplatin given at 100mg/m2 i.v. every 3 weeks for a total of 2 doses (days 1 and 22) during radiation.
1044618|NCT00707057|B3|Baseline|Total|Total of all reporting groups
1044619|NCT00707057|B2|Baseline|Placebo|Participants received placebo tablet twice daily (BID)
1044620|NCT00707057|B1|Baseline|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
1044621|NCT00707057|P2|Participant Flow|Placebo|Participants received placebo tablet twice daily (BID)
1044622|NCT00707057|P1|Participant Flow|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
1044623|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
1044624|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
1044625|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
1044626|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
1044627|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
1044628|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
1044629|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
1044630|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
1044631|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
1044632|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
1044633|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
1044639|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
1044640|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
1044641|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
1044642|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
1044643|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
1044644|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
1044645|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
1044646|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
1044647|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
1044648|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
1044649|NCT00707057|O2|Outcome|Placebo|Participants received placebo tablet twice daily (BID)
1044650|NCT00707057|O1|Outcome|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
1044651|NCT00707057|E2|Reported Event|Placebo|Participants received placebo tablet twice daily (BID)
1044652|NCT00707057|E1|Reported Event|Ibuprofen 600mg ER|Participants received 600 mg 12-hour extended-release tablets twice daily (BID).
1044653|NCT00707031|B3|Baseline|Total|Total of all reporting groups
1044654|NCT00707031|B2|Baseline|Exenatide|1-step initiation regimen of exenatide: 5 mcg BID subcutaneously for 4 weeks, followed by 10 mcg BID up to the end of treatment.
1044655|NCT00707031|B1|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
1044656|NCT00707031|P2|Participant Flow|Exenatide|1-step initiation regimen of exenatide: 5 mcg twice daily (BID) subcutaneously for 4 weeks, followed by 10 mcg BID up to the end of treatment.
1044657|NCT00707031|P1|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
1044658|NCT00707031|O2|Outcome|Exenatide|1-step initiation regimen of exenatide.
1044659|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1044660|NCT00707031|O2|Outcome|Exenatide|2-step initiation regimen of exenatide.
1044661|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1044662|NCT00707031|O2|Outcome|Exenatide|2-step initiation regimen of exenatide.
1044663|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1044664|NCT00707031|O2|Outcome|Exenatide|1-step initiation regimen of exenatide.
1044665|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1044666|NCT00707031|O2|Outcome|Exenatide|1-step initiation regimen of exenatide.
1044667|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1044668|NCT00707031|O2|Outcome|Exenatide|1-step initiation regimen of exenatide.
1044669|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1044670|NCT00707031|O2|Outcome|Exenatide|1-step initiation regimen of exenatide.
1044671|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1044672|NCT00707031|O2|Outcome|Exenatide|1-step initiation regimen of exenatide.
1044673|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1044674|NCT00707031|O2|Outcome|Exenatide|1-step initiation regimen of exenatide.
1044675|NCT00707031|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
1044676|NCT00707031|E2|Reported Event|Exenatide|1-step initiation regimen of exenatide.
1044677|NCT00707031|E1|Reported Event|Lixisenatide|2-step initiation regimen of lixisenatide.
1044678|NCT00706992|B8|Baseline|Total|Total of all reporting groups
1044679|NCT00706992|B7|Baseline|Arm VII|Patients receive ALVAC-MART-1 vaccine SC on days 0 and 14. ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
1044680|NCT00706992|B6|Baseline|Arm VI|Patients receive anti-MART-1 F5 TCR-transduced PBLs and ALVAC-MART-1 vaccine as in arm V, and low-dose aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL)+ 125,000 IU/kg/day subcutaneously.
1044681|NCT00706992|B5|Baseline|Arm V|Patients receive anti-MART-1 F5 TCR-transduced PBLs IV over 20-30 minutes on day 0, and ALVAC-MART-1 vaccine SC on days 0 and 14. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
1044682|NCT00706992|B4|Baseline|Arm IV|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I, MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 as in arm II, and aldesleukin as in arm III. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
1044683|NCT00706992|B3|Baseline|Arm III|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
1044684|NCT00706992|B2|Baseline|Arm II|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on days 0 and 30. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously.
1044685|NCT00706992|B1|Baseline|Arm I|Patients receive anti-MART-1 F5 TCR-transduced peripheral blood lymphocytes (PBLs) intravenously (IV) over 20-30 minutes on day 0. 1 x 10e9 to 5 x 10e10 IV.
1044686|NCT00706992|P7|Participant Flow|Arm VII - Adj-4 A2 ALVAC MART-1 Vaccine|Patients receive ALVAC-MART-1 vaccine SC on days 0 and 14. ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
1054437|NCT00683618|O1|Outcome|Rosuvastatin 10mg|Taken orally once daily
1046363|NCT00704418|E1|Reported Event|Bromfenac|Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily
1044687|NCT00706992|P6|Participant Flow|Arm VI-Adj-4 A2 F5 Cells + ALVAC MART-1 Vaccine + SQ IL-2|Patients receive anti-MART-1 F5 TCR-transduced PBLs and ALVAC-MART-1 vaccine as in arm V, and low-dose aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL)+ 125,000 IU/kg/day subcutaneously.
1044688|NCT00706992|P5|Participant Flow|Arm V-Adj-4 A2 F5 Cells + ALVAC MART-1:26-35(27L) Vaccine|Patients receive anti-MART-1 F5 TCR-transduced PBLs IV over 20-30 minutes on day 0, and ALVAC-MART-1 vaccine SC on days 0 and 14. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
1044689|NCT00706992|P4|Participant Flow|Arm IV-Adj-4 A2 F5 Cells + MART-1:26-35(27L) Peptide + SQ IL-2|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I, MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 as in arm II, and aldesleukin as in arm III. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
1044690|NCT00706992|P3|Participant Flow|Arm III - Adj-4 A2 F5 Cells + SQ IL-2|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
1044691|NCT00706992|P2|Participant Flow|Arm II-Adj-4 A2 F5 Cells + MART-1:26-35(27L) Peptide|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on days 0 and 30. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously.
1044692|NCT00706992|P1|Participant Flow|Arm I - Adj-4 A2 F5 Cells|Patients receive anti-MART-1 F5 TCR-transduced peripheral blood lymphocytes (PBLs) intravenously (IV) over 20-30 minutes on day 0. 1 x 10e9 to 5 x 10e10 IV.
1044693|NCT00706992|O7|Outcome|Arm VII - Adj-4 A2 ALVAC MART-1 Vaccine|Patients receive ALVAC-MART-1 vaccine SC on days 0 and 14. ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
1044694|NCT00706992|O6|Outcome|Arm VI-Adj-4 A2 F5 Cells + ALVAC MART-1 Vaccine + SQ IL-2|Patients receive anti-MART-1 F5 TCR-transduced PBLs and ALVAC-MART-1 vaccine as in arm V, and low-dose aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL)+ 125,000 IU/kg/day subcutaneously.
1044695|NCT00706992|O5|Outcome|Arm V-Adj-4 A2 F5 Cells + ALVAC MART-1:26-35(27L) Vaccine|Patients receive anti-MART-1 F5 TCR-transduced PBLs IV over 20-30 minutes on day 0, and ALVAC-MART-1 vaccine SC on days 0 and 14. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
1044696|NCT00706992|O4|Outcome|Arm IV-Adj-4 A2 F5 Cells + MART-1:26-35(27L) Peptide + SQ IL-2|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I, MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 as in arm II, and aldesleukin as in arm III. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
1044697|NCT00706992|O3|Outcome|Arm III - Adj-4 A2 F5 Cells + SQ IL-2|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
1044698|NCT00706992|O2|Outcome|Arm II-Adj-4 A2 F5 Cells + MART-1:26-35(27L) Peptide|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on days 0 and 30. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously.
1044699|NCT00706992|O1|Outcome|Arm I - Adj-4 A2 F5 Cells|Patients receive anti-MART-1 F5 TCR-transduced peripheral blood lymphocytes (PBLs) intravenously (IV) over 20-30 minutes on day 0. 1 x 10e9 to 5 x 10e10 IV.
1044700|NCT00706992|O1|Outcome|Arm I - 6|Arm I - Adj-4 A2 F5 cells Arm II-Adj-4 A2 F5 cells + MART-1:26-35(27L) Peptide Arm III-Adj-4 A2 F5 cells + SQ IL-2 Arm IV-Adj-4 A2 F5 cells + MART-1:26-35(27L) Peptide+SQ IL-2 Arm V-Adj-4 A2 F5 cells + ALVAC MART-1:26-35(27L) Vaccine Arm VI-Adj-4 A2 F5 cells + ALVAC MART-1 Vaccine + SQ IL-2
1044701|NCT00706992|E7|Reported Event|Arm VII|Patients receive ALVAC-MART-1 vaccine SC on days 0 and 14. ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
1044702|NCT00706992|E6|Reported Event|Arm VI|Patients receive anti-MART-1 F5 TCR-transduced PBLs and ALVAC-MART-1 vaccine as in arm V, and low-dose aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL)+ 125,000 IU/kg/day subcutaneously.
1044703|NCT00706992|E5|Reported Event|Arm V|Patients receive anti-MART-1 F5 TCR-transduced PBLs IV over 20-30 minutes on day 0, and ALVAC-MART-1 vaccine SC on days 0 and 14. 1 x 10e9 to 5 x 10e10 IV + ALVAC vaccine 0.5 ml containing target dose of 10e7 CCID50 (with a range of approximately 10^6.4 to 10^7.9/mL subcutaneously (total of 4 x 10e7 CCID50/2 mL).
1044704|NCT00706992|E4|Reported Event|Arm IV|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I, MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 as in arm II, and aldesleukin as in arm III. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
1044705|NCT00706992|E3|Reported Event|Arm III|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and aldesleukin SC on days 0-4. 1 x 10e9 to 5 x 10e10 IV + IL-2 (based on body weight) 125,000 IU/kg/day subcutaneously.
1044706|NCT00706992|E2|Reported Event|Arm II|Patients receive anti-MART-1 F5 TCR-transduced PBLs as in arm I and MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on days 0 and 30. 1 x 10e9 to 5 x 10e10 IV + 1.0 mg peptide subcutaneously.
1044707|NCT00706992|E1|Reported Event|Arm I|Patients receive anti-MART-1 F5 TCR-transduced peripheral blood lymphocytes (PBLs) intravenously (IV) over 20-30 minutes on day 0. 1 x 10e9 to 5 x 10e10 IV.
1044708|NCT00706979|B3|Baseline|Total|Total of all reporting groups
1044709|NCT00706979|B2|Baseline|Practice Quit Attempt Only|This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
1044710|NCT00706979|B1|Baseline|Practice Quit Attempt Plus Nicotine Replacement Therapy|This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
1046359|NCT00704418|O1|Outcome|Bromfenac|Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily
1044711|NCT00706979|P2|Participant Flow|Practice Quit Attempt Only|This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
1044712|NCT00706979|P1|Participant Flow|Practice Quit Attempt Plus Nicotine Replacement Therapy|This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
1044713|NCT00706979|O2|Outcome|Practice Quit Attempt Only|This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
1044714|NCT00706979|O1|Outcome|Practice Quit Attempt Plus Nicotine Replacement Therapy|This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
1044715|NCT00706979|O2|Outcome|Practice Quit Attempt Only|This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
1044716|NCT00706979|O1|Outcome|Practice Quit Attempt Plus Nicotine Replacement Therapy|This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
1044717|NCT00706979|O2|Outcome|Practice Quit Attempt Only|This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
1044718|NCT00706979|O1|Outcome|Practice Quit Attempt Plus Nicotine Replacement Therapy|This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
1044719|NCT00706979|O2|Outcome|Practice Quit Attempt Only|This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
1044720|NCT00706979|O1|Outcome|Practice Quit Attempt Plus Nicotine Replacement Therapy|This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
1044721|NCT00706979|E2|Reported Event|Practice Quit Attempt Only|This group served as the control group and received only the behavioral exercise of a practice quit attempt (PQA).
1044722|NCT00706979|E1|Reported Event|Practice Quit Attempt Plus Nicotine Replacement Therapy|This group received both the behavioral exercise of a practice quit attempt (PQA) and free nicotine replacement therapy (NRT) in the form of a lozenge for a 6-week treatment period.
1044723|NCT00706966|B1|Baseline|Dutasteride|"Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months~dutasteride : 6 months of dutasteride 3.5 mg daily"
1044724|NCT00706966|P1|Participant Flow|Dutasteride|"Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months~dutasteride : 6 months of dutasteride 3.5 mg daily"
1044725|NCT00706966|O4|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. Testosterone was measured at 6 months.
1044726|NCT00706966|O3|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. Testosterone was measured at 3 months.
1044727|NCT00706966|O2|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. Testosterone was measured at 1 month.
1044728|NCT00706966|O1|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. Testosterone was measured at Baseline.
1044729|NCT00706966|O4|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. DHT was measured at 6 months.
1044730|NCT00706966|O3|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. DHT was measured at 3 months.
1044731|NCT00706966|O2|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. DHT was measured at 1 month.
1044732|NCT00706966|O1|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. DHT was measured at Baseline.
1044733|NCT00706966|O4|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. PSA was measured at 6 months.
1044734|NCT00706966|O3|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. PSA was measured at 3 months.
1044735|NCT00706966|O2|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. PSA was measured at 1 month.
1044736|NCT00706966|O1|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. PSA was measured at Baseline.
1044737|NCT00706966|O4|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. SQLI was assessed at 6 months.
1044738|NCT00706966|O3|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. SQLI was assessed at 3 months.
1044739|NCT00706966|O2|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. SQLI was assessed at 1 month.
1044740|NCT00706966|O1|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. SQLI was assessed at Baseline.
1044741|NCT00706966|O4|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. FACE was assessed at 6 months.
1044742|NCT00706966|O3|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. FACE was assessed at 3 months.
1044743|NCT00706966|O2|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. FACE was assessed at 1 month.
1044744|NCT00706966|O1|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. FACE was assessed at Baseline.
1044840|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1044745|NCT00706966|O4|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IIEF-5 was assessed at 6 months.
1044746|NCT00706966|O3|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IIEF-5 was assessed at 3 months.
1044747|NCT00706966|O2|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IIEF-5 was assessed at 1 month.
1044748|NCT00706966|O1|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IIEF-5 was assessed at baseline.
1044749|NCT00706966|O4|Outcome|Dutasteride - 6 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 6 months.
1044750|NCT00706966|O3|Outcome|Dutasteride - 3 Months|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 3 months.
1044751|NCT00706966|O2|Outcome|Dutasteride - 1 Month|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 1 month.
1044752|NCT00706966|O1|Outcome|Dutasteride - Baseline|Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at Baseline.
1044753|NCT00706966|O1|Outcome|Dutasteride|"Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months~dutasteride : 6 months of dutasteride 3.5 mg daily"
1044754|NCT00706966|O1|Outcome|Dutasteride|"Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months~dutasteride : 6 months of dutasteride 3.5 mg daily"
1044755|NCT00706966|E1|Reported Event|Dutasteride|"Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months~dutasteride: 6 months of dutasteride 3.5 mg daily"
1044756|NCT00706914|B4|Baseline|Total|Total of all reporting groups
1044757|NCT00706914|B3|Baseline|Formoterol BID|Formoterol fumarate 12 μg twice-daily (BID)
1044758|NCT00706914|B2|Baseline|Morning Aclidinium/Formoterol Plus Evening Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening
1044759|NCT00706914|B1|Baseline|Once-daily Aclidinium/Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening
1044760|NCT00706914|P3|Participant Flow|Formoterol BID|Formoterol fumarate 12 μg twice-daily (BID)
1044761|NCT00706914|P2|Participant Flow|Morning Aclidinium/Formoterol Plus Evening Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening
1044762|NCT00706914|P1|Participant Flow|Once-daily Aclidinium/Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening
1044763|NCT00706914|O3|Outcome|Formoterol BID|Formoterol fumarate 12 μg twice-daily (BID)
1044764|NCT00706914|O2|Outcome|Morning Aclidinium/Formoterol Plus Evening Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening
1044765|NCT00706914|O1|Outcome|Once-daily Aclidinium/Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening
1044766|NCT00706914|O3|Outcome|Formoterol BID|Formoterol fumarate 12 μg twice-daily (BID)
1044767|NCT00706914|O2|Outcome|Morning Aclidinium/Formoterol Plus Evening Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening
1044768|NCT00706914|O1|Outcome|Once-daily Aclidinium/Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening
1044769|NCT00706914|O3|Outcome|Formoterol BID|Formoterol fumarate 12 μg twice-daily (BID)
1044770|NCT00706914|O2|Outcome|Morning Aclidinium/Formoterol Plus Evening Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening
1044771|NCT00706914|O1|Outcome|Once-daily Aclidinium/Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening
1044772|NCT00706914|O3|Outcome|Formoterol BID|Formoterol fumarate 12 μg twice-daily (BID)
1044773|NCT00706914|O2|Outcome|Morning Aclidinium/Formoterol Plus Evening Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening
1044774|NCT00706914|O1|Outcome|Once-daily Aclidinium/Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening
1044775|NCT00706914|O3|Outcome|Formoterol BID|Formoterol fumarate 12 μg twice-daily (BID)
1044776|NCT00706914|O2|Outcome|Morning Aclidinium/Formoterol Plus Evening Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening
1044777|NCT00706914|O1|Outcome|Once-daily Aclidinium/Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening
1044778|NCT00706914|E3|Reported Event|Formoterol BID|Formoterol fumarate 12 μg twice-daily (BID)
1044779|NCT00706914|E2|Reported Event|Morning Aclidinium/Formoterol Plus Evening Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus formoterol fumarate alone 12 μg once every evening
1044780|NCT00706914|E1|Reported Event|Once-daily Aclidinium/Formoterol|Aclidinium bromide 200 μg and formoterol fumarate 12 μg fixed-dose combination once-daily in the morning plus placebo once every evening
1044781|NCT00706901|B4|Baseline|Total|Total of all reporting groups
1044782|NCT00706901|B3|Baseline|Arm 3 TCC|Treatment Control condition
1044783|NCT00706901|B2|Baseline|Arm 2 IHMD|In-Home-Messaging Device
1044784|NCT00706901|B1|Baseline|Arm 1 GMI|Group Motivational Interviewing
1044785|NCT00706901|P3|Participant Flow|Arm 3 TCC|Participants in TCC first completed a baseline assessment, then returned 1 week later to attend four TCC sessions, each session lasting 75 minutes, administered on four consecutive days within the same week period. One and three months after the day of IRB consent, participants were provided 1 one-month and a 3-month follow-up, respectively.
1044786|NCT00706901|P2|Participant Flow|Arm 2 IHMD|Participants in IHMD first completed a baseline assessment, then received within a 1 week period their IHMD CCHT device to be used on a daily basis for 27 days in their home. One and three months after the day of IRB consent, participants were provided 1 one-month and a 3-month follow-up, respectively.
1044787|NCT00706901|P1|Participant Flow|Arm 1 GMI|Participants in GMI first completed a baseline assessment, then returned 1 week later to attend four GMI sessions, each session lasting 75 minutes, administered on four consecutive days within the same week period. One and three months after the day of IRB consent, participants were provided 1 one-month and a 3-month follow-up, respectively.
1044788|NCT00706901|O3|Outcome|Arm 3 TCC|Treatment Control Condition
1044789|NCT00706901|O2|Outcome|Arm 2 (IHMD)|In-Home-Messaging-Device
1044790|NCT00706901|O1|Outcome|Arm 1 GMI|Group Motivational Interviewing
1044791|NCT00706901|O3|Outcome|Arm 3 TCC|Treatment Control Condition
1044792|NCT00706901|O2|Outcome|Arm 2 (IHMD)|In-Home-Messaging-Device
1044793|NCT00706901|O1|Outcome|Arm 1 GMI|Group Motivational Interviewing
1044794|NCT00706901|O3|Outcome|Arm 3 TCC|Treatment Control Condition
1044795|NCT00706901|O2|Outcome|Arm 2 (IHMD)|In-Home-Messaging-Device
1044796|NCT00706901|O1|Outcome|Arm 1 GMI|Group Motivational Interviewing
1044797|NCT00706901|O3|Outcome|Arm 3 TCC|Treatment Control Condition
1044798|NCT00706901|O2|Outcome|Arm 2 (IHMD)|In-Home-Messaging-Device
1044799|NCT00706901|O1|Outcome|Arm 1 GMI|Group Motivational Interviewing
1044800|NCT00706901|O3|Outcome|Arm 3 TCC|Treatment Control Condition
1044801|NCT00706901|O2|Outcome|Arm 2 (IHMD)|In-Home-Messaging-Device
1044802|NCT00706901|O1|Outcome|Arm 1 GMI|Group Motivational Interviewing
1044803|NCT00706901|O3|Outcome|Arm 3 TCC|Treatment Control Condition
1044804|NCT00706901|O2|Outcome|Arm 2 IHMD|In Home Messaging Device
1044805|NCT00706901|O1|Outcome|Arm 1 GMI|Group Motivational Interviewing
1044806|NCT00706901|E3|Reported Event|Arm 3 TCC|Treatment Control Condition
1044807|NCT00706901|E2|Reported Event|Arm 2 IHMD|In Home Messaging Device
1044808|NCT00706901|E1|Reported Event|Arm 1 GMI|Group Motivational Interviewing
1044809|NCT00706849|B3|Baseline|Total|Total of all reporting groups
1044810|NCT00706849|B2|Baseline|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1044811|NCT00706849|B1|Baseline|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
1044812|NCT00706849|P2|Participant Flow|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1044813|NCT00706849|P1|Participant Flow|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
1044814|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1044815|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
1044816|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1044817|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
1044818|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1044819|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
1044820|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1044821|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
1044822|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1044823|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
1044824|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1044825|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
1044826|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1044827|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
1044828|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1044829|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
1044830|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1044831|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
1044832|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1044833|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
1044834|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1044835|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
1044836|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1044837|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
1044838|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1044839|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
1044841|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
1044842|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1044843|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
1044844|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1044845|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
1044846|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1044847|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
1044848|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1044849|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
1044850|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1044851|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
1044852|NCT00706849|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1044853|NCT00706849|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
1044854|NCT00706849|E2|Reported Event|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1044855|NCT00706849|E1|Reported Event|Placebo|Participants received a placebo subcutaneous injection once a week for 26 weeks.
1044856|NCT00706836|B1|Baseline|All 3 Treatments (Cross-Over Design)|"Pregabalin oral tablets (50 mg) Pregabalin oral tables (200 mg) Placebo~All subjects received all 3 treatments on different days.~Sequence data not available."
1044857|NCT00706836|P1|Participant Flow|All Study Participants|"Pregabalin oral tablets (50 mg) Pregabalin oral tablets (200 mg) Placebo~All participants received all 3 treatments on different days.~Sequence not available."
1044858|NCT00706836|O3|Outcome|Placebo (Crossover)|"Placebo~placebo: One dose of matched oral placebo to be administered one hour prior to fMRI scan"
1044859|NCT00706836|O2|Outcome|Pregabalin High Dose (Crossover)|"Pregabalin oral tablets (200 mg)~pregabalin: One dose of oral pregabalin (200 mg) to be administered one hour prior to fMRI scan"
1044860|NCT00706836|O1|Outcome|Pregabalin Low Dose (Crossover)|"Pregabalin oral tablets (50 mg)~pregabalin: One dose of oral pregabalin (50 mg) to be administered one hour prior to fMRI scan"
1044861|NCT00706836|E3|Reported Event|Placebo (Crossover)|"Placebo~placebo: One dose of matched oral placebo to be administered one hour prior to fMRI scan"
1044862|NCT00706836|E2|Reported Event|Pregabalin High Dose (Crossover)|"Pregabalin oral tablets (200 mg)~pregabalin: One dose of oral pregabalin (200 mg) to be administered one hour prior to fMRI scan"
1044863|NCT00706836|E1|Reported Event|Pregabalin Low Dose (Crossover)|"Pregabalin oral tablets (50 mg)~pregabalin: One dose of oral pregabalin (50 mg) to be administered one hour prior to fMRI scan"
1044864|NCT00706823|B3|Baseline|Total|Total of all reporting groups
1044865|NCT00706823|B2|Baseline|LMA-Unique|Patients who received LMA-Unique for intubation
1044866|NCT00706823|B1|Baseline|I-gel-SGA|Patients who received i-gel SGA for intubation
1044867|NCT00706823|P2|Participant Flow|LMA-Unique|"Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the model in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation."
1044868|NCT00706823|P1|Participant Flow|I-gel-SGA|Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.
1044869|NCT00706823|O2|Outcome|LMA-Unique|"Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the model in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation."
1044870|NCT00706823|O1|Outcome|I-gel-SGA|Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.
1044871|NCT00706823|O2|Outcome|LMA-Unique|"Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the model in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation."
1044872|NCT00706823|O1|Outcome|I-gel-SGA|Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.
1044888|NCT00706797|B3|Baseline|Total|Total of all reporting groups
1044889|NCT00706797|B2|Baseline|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
1044873|NCT00706823|O2|Outcome|LMA-Unique|"Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the model in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation."
1044874|NCT00706823|O1|Outcome|I-gel-SGA|Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.
1044875|NCT00706823|O2|Outcome|LMA-Unique|"Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the model in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation."
1044876|NCT00706823|O1|Outcome|I-gel-SGA|Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.
1044877|NCT00706823|O2|Outcome|LMA-Unique|"Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the model in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation."
1044878|NCT00706823|O1|Outcome|I-gel-SGA|Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.
1044879|NCT00706823|O2|Outcome|LMA-Unique|"Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the model in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation."
1044880|NCT00706823|O1|Outcome|I-gel-SGA|Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.
1044881|NCT00706823|E2|Reported Event|LMA-Unique|"Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the model in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation."
1044882|NCT00706823|E1|Reported Event|I-gel-SGA|Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.
1044883|NCT00706810|B1|Baseline|All Groups|
1044884|NCT00706810|P1|Participant Flow|All Participants|"Hydroxyurea: Hydroxyurea inhibits DNA synthesis by inhibition of ribonucleotide diphosphate reductase and is a well-known drug used for the treatment of a number of tumor types including head and neck tumors and chronic myelogenous leukemia. It has also been used as an adjuvant for antiretroviral treatment for patients with HIV and as a treatment for polycythemia vera, essential thrombocythemia and sickle cell disease.~Verapamil: Verapamil is another commonly used medication. It is used for the treatment of angina, hypertension, supraventricular arrhythmias, and migraine prophylaxis. Dosing with standard verapamil is 80-120 mg pox three times a day but the sustained release form can be given 120-480mg once or twice each day."
1044885|NCT00706810|O1|Outcome|All Participants|"Hydroxyurea: Hydroxyurea inhibits DNA synthesis by inhibition of ribonucleotide diphosphate reductase and is a well-known drug used for the treatment of a number of tumor types including head and neck tumors and chronic myelogenous leukemia. It has also been used as an adjuvant for antiretroviral treatment for patients with HIV and as a treatment for polycythemia vera, essential thrombocythemia and sickle cell disease.~Verapamil: Verapamil is another commonly used medication. It is used for the treatment of angina, hypertension, supraventricular arrhythmias, and migraine prophylaxis. Dosing with standard verapamil is 80-120 mg pox three times a day but the sustained release form can be given 120-480mg once or twice each day."
1044886|NCT00706810|O1|Outcome|All Groups|
1044887|NCT00706810|E1|Reported Event|All Participants|"Hydroxyurea: Hydroxyurea inhibits DNA synthesis by inhibition of ribonucleotide diphosphate reductase and is a well-known drug used for the treatment of a number of tumor types including head and neck tumors and chronic myelogenous leukemia. It has also been used as an adjuvant for antiretroviral treatment for patients with HIV and as a treatment for polycythemia vera, essential thrombocythemia and sickle cell disease.~Verapamil: Verapamil is another commonly used medication. It is used for the treatment of angina, hypertension, supraventricular arrhythmias, and migraine prophylaxis. Dosing with standard verapamil is 80-120 mg pox three times a day but the sustained release form can be given 120-480mg once or twice each day."
1044890|NCT00706797|B1|Baseline|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
1044891|NCT00706797|P2|Participant Flow|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
1044892|NCT00706797|P1|Participant Flow|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
1044893|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
1044894|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
1044895|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
1044896|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
1044897|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
1044898|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
1044899|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
1044900|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
1044901|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
1044902|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
1044903|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
1044904|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
1044905|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
1044906|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
1044907|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
1044908|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
1044909|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
1044910|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
1044911|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
1044912|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
1044913|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
1044914|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
1044915|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
1044916|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
1044917|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
1044918|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
1044919|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
1044920|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
1044921|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
1044922|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
1044923|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
1044924|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
1044925|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
1044926|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
1044927|NCT00706797|O2|Outcome|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
1044928|NCT00706797|O1|Outcome|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
1044929|NCT00706797|E2|Reported Event|ETN + MTX|Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
1044930|NCT00706797|E1|Reported Event|Usual Care|Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
1044931|NCT00706784|B3|Baseline|Total|Total of all reporting groups
1044932|NCT00706784|B2|Baseline|36 mg Leuprolide for 3 Days|
1044933|NCT00706784|B1|Baseline|18 mg Leuprolide for 3 Days|
1044934|NCT00706784|P2|Participant Flow|36 mg Leuprolide for 3 Days|
1044935|NCT00706784|P1|Participant Flow|18 mg Leuprolide for 3 Days|
1044936|NCT00706784|O2|Outcome|36 mg Leuprolide for 3 Days|
1044937|NCT00706784|O1|Outcome|18 mg Leuprolide for 3 Days|
1044938|NCT00706784|E2|Reported Event|36 mg Leuprolide for 3 Days|
1044939|NCT00706784|E1|Reported Event|18 mg Leuprolide for 3 Days|
1044940|NCT00706719|B4|Baseline|Total|Total of all reporting groups
1044941|NCT00706719|B3|Baseline|Group C Androxal Wash Out|25 mg 1 capsule per day in men who have undergone a 3 month wash out period of topical testosterone
1044942|NCT00706719|B2|Baseline|Group B Androxal no Wash Out|25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
1044943|NCT00706719|B1|Baseline|Group A Testim|1% Testim gel applied daily
1044944|NCT00706719|P3|Participant Flow|Group C Androxal With Wash Out|25 mg capsules once daily in men who have previously had a 3 month wash out of topical testosterone
1044945|NCT00706719|P2|Participant Flow|Group B Androxal no Washout|25 mg Androxal capsules once daily in men who have not previously washed out topical testosterone
1044946|NCT00706719|P1|Participant Flow|Group A Testim (Topical Testosterone)|1% Testim gel applied once daily
1044947|NCT00706719|O2|Outcome|Group B Androxal no Wash Out|25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
1044948|NCT00706719|O1|Outcome|Group A Testim|1% Testim gel applied daily
1044949|NCT00706719|O2|Outcome|Group B Androxal no Wash Out|25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
1044950|NCT00706719|O1|Outcome|Group A Testim|1% Testim gel applied daily
1044951|NCT00706719|O2|Outcome|Group B Androxal no Wash Out|25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
1044952|NCT00706719|O1|Outcome|Group A Testim|1% Testim gel applied daily
1044953|NCT00706719|O2|Outcome|Group B Androxal no Wash Out|25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
1044954|NCT00706719|O1|Outcome|Group A Testim|1% Testim gel applied daily
1044955|NCT00706719|O2|Outcome|Group B Androxal no Wash Out|25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
1044956|NCT00706719|O1|Outcome|Group A Testim|1% Testim gel applied daily
1044957|NCT00706719|E3|Reported Event|Androxal Wash Out|25 mg 1 capsule per day in men who have undergone a 3 month wash out period of topical testosterone
1044958|NCT00706719|E2|Reported Event|Group B Androxal no Wash Out|25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
1044959|NCT00706719|E1|Reported Event|Group A Testim|1% Testim gel applied daily
1044960|NCT00706706|B1|Baseline|Sunitinib|Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
1045518|NCT00706355|O3|Outcome|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1044961|NCT00706706|P1|Participant Flow|Sunitinib|Sunitinib 50 milligram (mg) capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
1044962|NCT00706706|O1|Outcome|Sunitinib|Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
1044963|NCT00706706|O1|Outcome|Sunitinib|Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
1044964|NCT00706706|O1|Outcome|Sunitinib|Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
1044965|NCT00706706|O1|Outcome|Sunitinib|Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
1044966|NCT00706706|E1|Reported Event|Sunitinib|Sunitinib 50 mg capsule orally once daily for 4 weeks followed by 2 weeks off-treatment period in cycles of 6 weeks until disease progression, unacceptable sunitinib-associated toxicity or withdrawal.
1044967|NCT00706654|B4|Baseline|Total|Total of all reporting groups
1044968|NCT00706654|B3|Baseline|Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase|Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
1044969|NCT00706654|B2|Baseline|Aripiprazole 10-30 mg Orally - Depot Maintenance Phase|Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
1044970|NCT00706654|B1|Baseline|Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
1044971|NCT00706654|P4|Participant Flow|Aripiprazole Depot 25 or 50 mg|Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
1044972|NCT00706654|P3|Participant Flow|Aripiprazole 10-30 mg Orally|Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
1044973|NCT00706654|P2|Participant Flow|Aripiprazole Depot 300 or 400 mg|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
1044974|NCT00706654|P1|Participant Flow|All Patients|During the Conversion Phase, patients were cross-titrated from other antipsychotics to oral non-generic aripiprazole monotherapy and during the Oral Stabilization Phase, patients were stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily.
1044975|NCT00706654|O3|Outcome|Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase|Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
1044976|NCT00706654|O2|Outcome|Aripiprazole 10-30 mg Orally - Depot Maintenance Phase|Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
1044977|NCT00706654|O1|Outcome|Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
1044978|NCT00706654|O3|Outcome|Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase|Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
1044979|NCT00706654|O2|Outcome|Aripiprazole 10-30 mg Orally - Depot Maintenance Phase|Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
1044980|NCT00706654|O1|Outcome|Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
1044981|NCT00706654|O3|Outcome|Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase|Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
1044982|NCT00706654|O2|Outcome|Aripiprazole 10-30 mg Orally - Depot Maintenance Phase|Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
1044983|NCT00706654|O1|Outcome|Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
1044984|NCT00706654|O3|Outcome|Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase|Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
1044985|NCT00706654|O2|Outcome|Aripiprazole 10-30 mg Orally - Depot Maintenance Phase|Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
1044986|NCT00706654|O1|Outcome|Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
1044987|NCT00706654|E5|Reported Event|Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase|Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
1044988|NCT00706654|E4|Reported Event|Aripiprazole 10-30 mg Orally - Depot Maintenance Phase|Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
1044989|NCT00706654|E3|Reported Event|Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
1044990|NCT00706654|E2|Reported Event|All Patients - Oral Stabilization Phase|During the Oral Stabilization Phase, patients were stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily.
1044991|NCT00706654|E1|Reported Event|All Patients - Conversion Phase|During the Conversion Phase, patients were cross-titrated from other antipsychotics to oral non-generic aripiprazole monotherapy.
1044992|NCT00706641|B1|Baseline|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
1045005|NCT00706628|B2|Baseline|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
1045006|NCT00706628|B1|Baseline|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
1044993|NCT00706641|P1|Participant Flow|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
1044994|NCT00706641|O1|Outcome|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
1044995|NCT00706641|O1|Outcome|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
1044996|NCT00706641|O1|Outcome|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
1044997|NCT00706641|O1|Outcome|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
1044998|NCT00706641|O1|Outcome|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
1044999|NCT00706641|O1|Outcome|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
1045000|NCT00706641|O1|Outcome|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
1045001|NCT00706641|E1|Reported Event|Experimental: Neoadjuvant Dasatinib + Radical Cystectomy|"Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose~Dasatinib: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)~Radical Cystectomy: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery."
1045002|NCT00706628|B5|Baseline|Total|Total of all reporting groups
1045003|NCT00706628|B4|Baseline|ComBI 70|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and Days 15 to 21 of each treatment cycle; BIBW 2992 70 mg QD on Days 8 to 14 and Days 22 to 28 of each treatment cycle.~The starting dose of BIBW 2992 was reduced due to an unexpectedly high incidence of severe (Grade 3) Adverse Events reported for the first 3 patients treated with ComBI 70. As the reported Adverse Events were attributed to BIBW 2992, the starting dose of BIBW 2992 in subsequent patients in this treatment arm was reduced to 40mg QD (ComBI 40); the dose of BIBF 1120 remained unchanged.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression."
1045004|NCT00706628|B3|Baseline|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
1045088|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
1046360|NCT00704418|O2|Outcome|Placebo|Placebo, dosed 1 drop daily
1045007|NCT00706628|P4|Participant Flow|ComBI 70|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and Days 15 to 21 of each treatment cycle; BIBW 2992 70 mg QD on Days 8 to 14 and Days 22 to 28 of each treatment cycle.~The starting dose of BIBW 2992 was reduced due to an unexpectedly high incidence of severe (Grade 3) Adverse Events (AE) reported for the first 3 patients treated with ComBI 70. As the reported Adverse Events were attributed to BIBW 2992, the starting dose of BIBW 2992 in subsequent patients in this treatment arm was reduced to 40mg QD (ComBI 40); the dose of BIBF 1120 remained unchanged.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression."
1045008|NCT00706628|P3|Participant Flow|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
1045009|NCT00706628|P2|Participant Flow|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
1045010|NCT00706628|P1|Participant Flow|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
1045011|NCT00706628|O1|Outcome|Combination Therapy of BIBF 1120 and BIBW 2992|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~C12,14 values of BIBF 1120 BS after sequential alternating 7−days administration of 250 mg BIBF 1120 bid;~C24,7, C24,14 and C24,42 values of BIBW 2992 BS after sequential alternating 7−days administration of 40 mg BIBW 2992 qd"
1045012|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
1045013|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
1045014|NCT00706628|O4|Outcome|ComBI 70|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and Days 15 to 21 of each treatment cycle; BIBW 2992 70 mg QD on Days 8 to 14 and Days 22 to 28 of each treatment cycle.~The starting dose of BIBW 2992 was reduced due to an unexpectedly high incidence of severe (Grade 3) Adverse Events reported for the first 3 patients treated with ComBI 70. As the reported Adverse Events were attributed to BIBW 2992, the starting dose of BIBW 2992 in subsequent patients in this treatment arm was reduced to 40mg QD (ComBI 40); the dose of BIBF 1120 remained unchanged.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression."
1045015|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
1045016|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
1045017|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
1045018|NCT00706628|O4|Outcome|ComBI 70|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and Days 15 to 21 of each treatment cycle; BIBW 2992 70 mg QD on Days 8 to 14 and Days 22 to 28 of each treatment cycle.~The starting dose of BIBW 2992 was reduced due to an unexpectedly high incidence of severe (Grade 3) Adverse Events reported for the first 3 patients treated with ComBI 70. As the reported Adverse Events were attributed to BIBW 2992, the starting dose of BIBW 2992 in subsequent patients in this treatment arm was reduced to 40mg QD (ComBI 40); the dose of BIBF 1120 remained unchanged.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression."
1045019|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
1045020|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
1045021|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
1045022|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
1045023|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
1045024|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
1045025|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
1045026|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
1045027|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
1045028|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
1045029|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
1045030|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
1045031|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21 BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
1045032|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
1045033|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
1045034|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
1045035|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
1045036|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
1045037|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
1045038|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
1045039|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
1045040|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21 BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
1045041|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
1045042|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
1045043|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
1045044|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
1045045|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
1045046|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
1045047|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
1045048|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
1045089|NCT00706563|E2|Reported Event|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
1045090|NCT00706563|E1|Reported Event|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
1045091|NCT00706550|B3|Baseline|Total|Total of all reporting groups
1045049|NCT00706628|O4|Outcome|ComBI 70|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and Days 15 to 21 of each treatment cycle; BIBW 2992 70 mg QD on Days 8 to 14 and Days 22 to 28 of each treatment cycle. The starting dose of BIBW 2992 was reduced due to an unexpectedly high incidence of severe (Grade 3) Adverse Events reported for the first 3 patients treated with ComBI 70. As the reported Adverse Events were attributed to BIBW 2992, the starting dose of BIBW 2992 in subsequent patients in this treatment arm was reduced to 40mg QD (ComBI 40); the dose of BIBF 1120 remained unchanged. Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression."
1045050|NCT00706628|O3|Outcome|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
1045051|NCT00706628|O2|Outcome|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
1045052|NCT00706628|O1|Outcome|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
1045053|NCT00706628|E4|Reported Event|ComBI 70|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and Days 15 to 21 of each treatment cycle; BIBW 2992 70 mg QD on Days 8 to 14 and Days 22 to 28 of each treatment cycle.~The starting dose of BIBW 2992 was reduced due to an unexpectedly high incidence of severe (Grade 3) Adverse Events reported for the first 3 patients treated with ComBI 70. As the reported Adverse Events were attributed to BIBW 2992, the starting dose of BIBW 2992 in subsequent patients in this treatment arm was reduced to 40mg QD (ComBI 40); the dose of BIBF 1120 remained unchanged.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression."
1045054|NCT00706628|E3|Reported Event|ComBI 40|"Sequential alternating BIBF 1120 and BIBW 2992 combination therapy.~Treatment regimen:~BIBF 1120 250 mg BID on Days 1 to 7 and 15 to 21, BIBW 2992 40 mg QD on Days 8 to 14 and 22 to 28.~Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression"
1045055|NCT00706628|E2|Reported Event|BIBW 2992 Monotherapy|40 mg tablets administered orally once a day (QD). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
1045056|NCT00706628|E1|Reported Event|BIBF 1120 Monotherapy|250 mg soft gelatine capsules administered orally twice a day (BID). Continuous daily dosing in 28-day cycles. Patients were eligible for repeated treatment cycles for 48 weeks in the absence of clinical disease progression.
1045057|NCT00706589|B3|Baseline|Total|Total of all reporting groups
1045058|NCT00706589|B2|Baseline|Placebo|Placebo 2mg,5mg,10mg,15mg
1045059|NCT00706589|B1|Baseline|Aripiprazole|Aripiprazole 2mg,5mg,10mg,15mg
1045060|NCT00706589|P2|Participant Flow|Placebo|Placebo 2mg,5mg,10mg,15mg, 20mg orally administrated Once a day (Titration according to the protocol)10mg,15mg, 20mg Mode of administration: P.O
1045061|NCT00706589|P1|Participant Flow|Aripiprazole|Aripiprazole 2mg,5mg,10mg,15mg, 20mg orally administrated Once a day (Titration according to the protocol) Mode of administration: P.O
1045062|NCT00706589|O2|Outcome|Placebo|Placebo 2mg,5mg,10mg,15mg, 20mg
1045063|NCT00706589|O1|Outcome|Aripiprazole|Aripiprazole 2mg,5mg,10mg,15mg, 20mg
1045064|NCT00706589|E2|Reported Event|Placebo|Placebo 2mg,5mg,10mg,15mg
1045065|NCT00706589|E1|Reported Event|Aripiprazole|Aripiprazole 2mg,5mg,10mg,15mg
1045066|NCT00706563|B3|Baseline|Total|Total of all reporting groups
1045067|NCT00706563|B2|Baseline|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
1045068|NCT00706563|B1|Baseline|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
1045069|NCT00706563|P2|Participant Flow|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
1045070|NCT00706563|P1|Participant Flow|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
1045071|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
1045072|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
1045073|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
1045074|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
1045075|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
1045076|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
1045077|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
1045078|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
1045079|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
1045080|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
1045081|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
1045082|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
1045083|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
1045084|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
1045085|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
1045086|NCT00706563|O1|Outcome|Fluarix Adult Group|Subjects who are 18-40 years of age received one dose of Fluarix™
1045087|NCT00706563|O2|Outcome|Fluarix Elderly Group|Subjects who are ≥ 60 years of age received one dose of Fluarix™
1045092|NCT00706550|B2|Baseline|Arm 2: PV After >6 Months of Antiretroviral Therapy|"Arm 2 received PV after at least 6 months of antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine"
1045093|NCT00706550|B1|Baseline|Arm 1: PV Before Starting Antiretroviral Therapy|"Arm 1 received PV prior to starting antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine"
1045094|NCT00706550|P2|Participant Flow|Delayed: PV After >6 Months of Antiretroviral Therapy|"Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
1045095|NCT00706550|P1|Participant Flow|Immediate: PV Before Starting Antiretroviral Therapy|"Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
1045096|NCT00706550|O2|Outcome|Delayed: PV After >6 Months of Antiretroviral Therapy|"Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
1045097|NCT00706550|O1|Outcome|Immediate: PV Before Starting Antiretroviral Therapy|"Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
1045098|NCT00706550|O2|Outcome|Delayed: PV After >6 Months of Antiretroviral Therapy|"Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
1045099|NCT00706550|O1|Outcome|Immediate: PV Before Starting Antiretroviral Therapy|"Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
1045100|NCT00706550|O2|Outcome|Delayed: PV After >6 Months of Antiretroviral Therapy|"Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
1045101|NCT00706550|O1|Outcome|Immediate: PV Before Starting Antiretroviral Therapy|"Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
1045102|NCT00706550|O2|Outcome|Delayed: PV After >6 Months of Antiretroviral Therapy|"Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
1045103|NCT00706550|O1|Outcome|Immediate: PV Before Starting Antiretroviral Therapy|"Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
1045104|NCT00706550|O2|Outcome|Delayed: PV After >6 Months of Antiretroviral Therapy|"Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
1045105|NCT00706550|O1|Outcome|Immediate: PV Before Starting Antiretroviral Therapy|"Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
1045106|NCT00706550|O2|Outcome|Delayed: PV After >6 Months of Antiretroviral Therapy|"Delayed group (Arm 2) received PV after at least 6 months of antiretroviral treatment~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine."
1045107|NCT00706550|O1|Outcome|Immediate: PV Before Starting Antiretroviral Therapy|"Immediate group (Arm 1) received PV prior to starting antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine"
1045108|NCT00706550|E2|Reported Event|Arm 2: PV After >6 Months of Antiretroviral Therapy|"Arm 2 received PV after at least 6 months of antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine"
1045109|NCT00706550|E1|Reported Event|Arm 1: PV Before Starting Antiretroviral Therapy|"Arm 1 received PV prior to starting antiretroviral treatment.~PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine"
1045110|NCT00706485|B1|Baseline|Dural Brachytherapy Plaque|"Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.~Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes"
1045111|NCT00706485|P1|Participant Flow|Dural Brachytherapy Plaque|"Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.~Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes"
1045112|NCT00706485|O1|Outcome|Dural Brachytherapy Plaque|"Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.~Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes"
1045113|NCT00706485|O1|Outcome|Dural Brachytherapy Plaque|"Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.~Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes"
1045114|NCT00706485|O1|Outcome|Dural Brachytherapy Plaque|"Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.~Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes"
1045115|NCT00706485|E1|Reported Event|Dural Brachytherapy Plaque|"Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.~Yttrium-90 Plaque Applicator: Placed on the dura during surgery for 10-17 1/2 minutes"
1045116|NCT00706446|B7|Baseline|Total|Total of all reporting groups
1045172|NCT00706433|P2|Participant Flow|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045173|NCT00706433|P1|Participant Flow|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045174|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045117|NCT00706446|B6|Baseline|6 - Salmeterol or Formoterol Plus ICS in the Gly/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
1045118|NCT00706446|B5|Baseline|5 - Salmeterol or Formoterol Plus ICS in the Arg/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
1045119|NCT00706446|B4|Baseline|4 - Salmeterol or Formoterol Plus ICS in the Arg/Arg Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
1045120|NCT00706446|B3|Baseline|3 - Tiotropium Plus ICS in the Gly/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.p"
1045121|NCT00706446|B2|Baseline|2 - Tiotropium Plus ICS in the Arg/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
1045122|NCT00706446|B1|Baseline|1 - Tiotropium Plus ICS in the Arg/Arg Genotype|"Tiotropium bromide 18 mcg qd plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, ddosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
1045123|NCT00706446|P6|Participant Flow|6 - Salmeterol or Formoterol Plus ICS in the Gly/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
1045175|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045176|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045124|NCT00706446|P5|Participant Flow|5 - Salmeterol or Formoterol Plus ICS in the Arg/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
1045125|NCT00706446|P4|Participant Flow|4 - Salmeterol or Formoterol Plus ICS in the Arg/Arg Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
1045126|NCT00706446|P3|Participant Flow|3 - Tiotropium Plus ICS in the Gly/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.p"
1045127|NCT00706446|P2|Participant Flow|2 - Tiotropium Plus ICS in the Arg/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
1045128|NCT00706446|P1|Participant Flow|1 - Tiotropium Plus ICS in the Arg/Arg Genotype|"Tiotropium bromide 18 mcg qd plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, ddosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
1045129|NCT00706446|O6|Outcome|6 - Salmeterol or Formoterol Plus ICS in the Gly/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
1045130|NCT00706446|O5|Outcome|5 - Salmeterol or Formoterol Plus ICS in the Arg/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
1045177|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045178|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045131|NCT00706446|O4|Outcome|4 - Salmeterol or Formoterol Plus ICS in the Arg/Arg Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
1045132|NCT00706446|O3|Outcome|3 - Tiotropium Plus ICS in the Gly/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.p"
1045133|NCT00706446|O2|Outcome|2 - Tiotropium Plus ICS in the Arg/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
1045134|NCT00706446|O1|Outcome|1 - Tiotropium Plus ICS in the Arg/Arg Genotype|"Tiotropium bromide 18 mcg qd plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, ddosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
1045135|NCT00706446|O6|Outcome|6 - Salmeterol or Formoterol Plus ICS in the Gly/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
1045136|NCT00706446|O5|Outcome|5 - Salmeterol or Formoterol Plus ICS in the Arg/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
1045137|NCT00706446|O4|Outcome|4 - Salmeterol or Formoterol Plus ICS in the Arg/Arg Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
1045179|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045180|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1054438|NCT00683618|O2|Outcome|Atorvastatin 10mg|Taken orally once daily
1045138|NCT00706446|O3|Outcome|3 - Tiotropium Plus ICS in the Gly/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.p"
1045139|NCT00706446|O2|Outcome|2 - Tiotropium Plus ICS in the Arg/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
1045140|NCT00706446|O1|Outcome|1 - Tiotropium Plus ICS in the Arg/Arg Genotype|"Tiotropium bromide 18 mcg qd plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, ddosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
1045141|NCT00706446|O6|Outcome|6 - Salmeterol or Formoterol Plus ICS in the Gly/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
1045142|NCT00706446|O5|Outcome|5 - Salmeterol or Formoterol Plus ICS in the Arg/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
1045143|NCT00706446|O4|Outcome|4 - Salmeterol or Formoterol Plus ICS in the Arg/Arg Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
1045144|NCT00706446|O3|Outcome|3 - Tiotropium Plus ICS in the Gly/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.p"
1045181|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045182|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045572|NCT00706134|O3|Outcome|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
1045145|NCT00706446|O2|Outcome|2 - Tiotropium Plus ICS in the Arg/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
1045146|NCT00706446|O1|Outcome|1 - Tiotropium Plus ICS in the Arg/Arg Genotype|"Tiotropium bromide 18 mcg qd plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, ddosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
1045147|NCT00706446|O6|Outcome|6 - Salmeterol or Formoterol Plus ICS in the Gly/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
1045148|NCT00706446|O5|Outcome|5 - Salmeterol or Formoterol Plus ICS in the Arg/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
1045149|NCT00706446|O4|Outcome|4 - Salmeterol or Formoterol Plus ICS in the Arg/Arg Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
1045150|NCT00706446|O3|Outcome|3 - Tiotropium Plus ICS in the Gly/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.p"
1045151|NCT00706446|O2|Outcome|2 - Tiotropium Plus ICS in the Arg/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
1045183|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045184|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045573|NCT00706134|O2|Outcome|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
1045152|NCT00706446|O1|Outcome|1 - Tiotropium Plus ICS in the Arg/Arg Genotype|"Tiotropium bromide 18 mcg qd plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, ddosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
1045153|NCT00706446|O6|Outcome|6 - Salmeterol or Formoterol Plus ICS in the Gly/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
1045154|NCT00706446|O5|Outcome|5 - Salmeterol or Formoterol Plus ICS in the Arg/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg-Gly genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
1045155|NCT00706446|O4|Outcome|4 - Salmeterol or Formoterol Plus ICS in the Arg/Arg Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~Salmeterol: salmeterol diskus 1 puff twice a day for 1 year OR~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year,~OR budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year. Dosing based on patient's prior inhaled steroid dosing."
1045156|NCT00706446|O3|Outcome|3 - Tiotropium Plus ICS in the Gly/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.p"
1045157|NCT00706446|O2|Outcome|2 - Tiotropium Plus ICS in the Arg/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
1045158|NCT00706446|O1|Outcome|1 - Tiotropium Plus ICS in the Arg/Arg Genotype|"Tiotropium bromide 18 mcg qd plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, ddosing based on patient's prior inhaled steroid dosing and treating physician's judgement."
1045185|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045186|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045574|NCT00706134|O1|Outcome|Placebo|Placebo tablet taken once daily in the morning with a light meal.
1045159|NCT00706446|E6|Reported Event|6 - LABA/ICS in the Gly/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly-Gly genotype Salmeterol: salmeterol diskus 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial. The goal of this intervention is to continue the patient's current therapy of long-acting beta-agonists. In addition, the patients will be on inhaled steroids at variable doses, depending on what dose they were on at the start of the trial and based on the judgement of their treating physicians.~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial. The goal of this in"
1045160|NCT00706446|E5|Reported Event|5 - LABA/ICS in the Arg/Gly Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype Salmeterol: salmeterol diskus 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial. The goal of this intervention is to continue the patient's current therapy of long-acting beta-agonists. In addition, the patients will be on inhaled steroids at variable doses, depending on what dose they were on at the start of the trial and based on the judgement of their treating physicians.~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial. The goal of this in"
1045161|NCT00706446|E4|Reported Event|4 - LABA/ICS in the Arg/Arg Genotype|"Salmeterol 50 mcg 1 puff BID or Formoterol 12mcg 1 puff BID plus inhaled steroid, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype Salmeterol: salmeterol diskus 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial. The goal of this intervention is to continue the patient's current therapy of long-acting beta-agonists. In addition, the patients will be on inhaled steroids at variable doses, depending on what dose they were on at the start of the trial and based on the judgement of their treating physicians.~Formoterol: formoterol aerolizer 12 mcg 1 puff twice a day for 1 year, depending on which medication the patient was on before the start of the trial. The goal of this in"
1045162|NCT00706446|E3|Reported Event|3 - Tio/ICS in the Gly/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Gly/Gly genotype tiotropium bromide: tiotropium bromide one inhalation a day for one year, along with inhaled steroids at variable dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, depending on which dose the patient was on before the start of the trial.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, depending on which dose the p"
1045163|NCT00706446|E2|Reported Event|2 - Tio/ICS in the Arg/Gly Genotype|"Tiotropium bromide 18 mcg QD plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Gly genotype tiotropium bromide: tiotropium bromide one inhalation a day for one year, along with inhaled steroids at variable dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, depending on which dose the patient was on before the start of the trial.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, depending on which dose the p"
1045164|NCT00706446|E1|Reported Event|1 - Tio/ICS in the Arg/Arg Genotype|"Tiotropium bromide 18 mcg qd plus inhaled steroids, either Fluticasone propionate Diskus 100 mcg 1 puff bid, Fluticasone propionate aerosol 44 mcg 2 puffs bid, Fluticasone propionate aerosol 110 mcg 2 puffs bid, Fluticasone propionate aerosol 220 mcg 2 puffs qd, Budesonide 90 mcg 2 puffs bid, or Budesonide 180 mcg 2 puffs bid, in the Arg/Arg genotype~tiotropium bromide: tiotropium bromide one inhalation a day for one year, along with inhaled steroids at variable dosing based on patient's prior inhaled steroid dosing and treating physician's judgement.~Fluticasone propionate: Either fluticasone propionate diskus 100 mcg 1 puff twice a day or fluticasone propionate aersol in 44 mcg, 110 mcg, 2 puffs twice a day OR fluticasone propionate 220 mcg 2 puffs once a day for one year, depending on which dose the patient was on before the start of the trial.~budesonide: Either budesonide 90 mcg 2 puffs twice a day or 180 mcg 2 puffs twice a day for one year, depending on which dose the p"
1045165|NCT00706433|B5|Baseline|Total|Total of all reporting groups
1045166|NCT00706433|B4|Baseline|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045167|NCT00706433|B3|Baseline|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045168|NCT00706433|B2|Baseline|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045169|NCT00706433|B1|Baseline|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045170|NCT00706433|P4|Participant Flow|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045171|NCT00706433|P3|Participant Flow|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1046361|NCT00704418|O1|Outcome|Bromfenac|Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily
1045187|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045188|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045189|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045190|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045191|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045192|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045193|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045194|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045195|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045196|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045197|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045198|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045199|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045200|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045201|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045202|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045203|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045204|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045205|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045206|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045207|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045208|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045209|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045210|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045211|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045212|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045213|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045214|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045215|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045216|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045217|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045218|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045219|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045220|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045221|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045222|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045575|NCT00706134|O4|Outcome|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
1045223|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045224|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045225|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045226|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045227|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045228|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045229|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045230|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045231|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045232|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045233|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045234|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045235|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045236|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045237|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045238|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045239|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045240|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045241|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045242|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045243|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045244|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045245|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045246|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045247|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045248|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045249|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045250|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045251|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045252|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045253|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045254|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045255|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045256|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045257|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045258|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045576|NCT00706134|O3|Outcome|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
1045259|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045260|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045261|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045262|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045263|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045264|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045265|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045266|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045267|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045268|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045269|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045270|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045271|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045272|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045273|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045274|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045275|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045276|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045277|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045278|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045279|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045280|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045281|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045282|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045283|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045284|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045285|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045286|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045287|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045288|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045289|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045290|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045291|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045292|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045293|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045294|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045577|NCT00706134|O2|Outcome|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
1045295|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045296|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045297|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045298|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045299|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045300|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045301|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045302|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045303|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045304|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045305|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045306|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045307|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045308|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045309|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045310|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045311|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045312|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045313|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045314|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045315|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045316|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045317|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045318|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045319|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045320|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045321|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045322|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045323|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045324|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045325|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045326|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045327|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045328|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045329|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045330|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045578|NCT00706134|O1|Outcome|Placebo|Placebo tablet taken once daily in the morning with a light meal.
1045331|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045332|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045333|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045334|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045335|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045336|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045337|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045338|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045339|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045340|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045341|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045342|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045343|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045344|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045345|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045346|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045347|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045348|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045349|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045350|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045351|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045352|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045353|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045354|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045355|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045356|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045357|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045358|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045359|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045360|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045361|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045362|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045363|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045364|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045365|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045366|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045579|NCT00706134|O4|Outcome|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
1045367|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045368|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045369|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045370|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045371|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045372|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045373|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045374|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045375|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045376|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045377|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045378|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045379|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045380|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045381|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045382|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045383|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045384|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045385|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045386|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045387|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045388|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045389|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045390|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045391|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045392|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045393|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045394|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045395|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045396|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045397|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045398|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045399|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045400|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045401|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045402|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045580|NCT00706134|O3|Outcome|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
1045403|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045404|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045405|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045406|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045407|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045408|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045409|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045410|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045411|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045412|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045413|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045414|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045415|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045416|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045417|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045418|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045419|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045420|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045421|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045422|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045423|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045424|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045425|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045426|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045427|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045428|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045429|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045430|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045431|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045432|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045433|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045434|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045435|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045436|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045437|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045438|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045581|NCT00706134|O2|Outcome|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
1045439|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045440|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045441|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045442|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045443|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045444|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045445|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045446|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045447|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045448|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045449|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045450|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045451|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045452|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045453|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045454|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045455|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045456|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045457|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045458|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045459|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045460|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045461|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045462|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045463|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045464|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045465|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045466|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045467|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045468|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045469|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045470|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045471|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045472|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045473|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045474|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045582|NCT00706134|O1|Outcome|Placebo|Placebo tablet taken once daily in the morning with a light meal.
1045475|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045476|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045477|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045478|NCT00706433|O4|Outcome|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045479|NCT00706433|O3|Outcome|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045480|NCT00706433|O2|Outcome|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045481|NCT00706433|O1|Outcome|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045482|NCT00706433|E4|Reported Event|Vehicle 500 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
1045483|NCT00706433|E3|Reported Event|Vehicle 1000 Seconds|Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045484|NCT00706433|E2|Reported Event|ALA 500 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)
1045485|NCT00706433|E1|Reported Event|ALA 1000 Seconds|Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)
1045486|NCT00706355|B5|Baseline|Total|Total of all reporting groups
1045487|NCT00706355|B4|Baseline|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045488|NCT00706355|B3|Baseline|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045489|NCT00706355|B2|Baseline|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045490|NCT00706355|B1|Baseline|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045491|NCT00706355|P4|Participant Flow|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045492|NCT00706355|P3|Participant Flow|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045493|NCT00706355|P2|Participant Flow|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045494|NCT00706355|P1|Participant Flow|PF-04217903 50 mg|Two tablets 25 milligram (mg) PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045495|NCT00706355|O4|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045496|NCT00706355|O3|Outcome|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045497|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045498|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045499|NCT00706355|O4|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045500|NCT00706355|O3|Outcome|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045501|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045502|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045503|NCT00706355|O3|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045504|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045505|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045506|NCT00706355|O4|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045507|NCT00706355|O3|Outcome|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045508|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045509|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045510|NCT00706355|O3|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045511|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045512|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045513|NCT00706355|O4|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045514|NCT00706355|O3|Outcome|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045515|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045516|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045517|NCT00706355|O4|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045519|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045520|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045521|NCT00706355|O3|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045522|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045523|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045524|NCT00706355|O4|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045525|NCT00706355|O3|Outcome|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045526|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045527|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045528|NCT00706355|O3|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045529|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045530|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045531|NCT00706355|O4|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045532|NCT00706355|O3|Outcome|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045533|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045534|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045535|NCT00706355|O4|Outcome|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045536|NCT00706355|O3|Outcome|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045537|NCT00706355|O2|Outcome|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045538|NCT00706355|O1|Outcome|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045539|NCT00706355|O1|Outcome|All Treated Participants|All participants who received PF-04217903 tablet (50 mg, 100 mg, 200 mg and 150 mg) orally twice a day in continuous 21-day cycles.
1045540|NCT00706355|O1|Outcome|All Treated Participants|All participants who received PF-04217903 tablet (50 mg, 100 mg, 200 mg and 150 mg) orally twice a day in continuous 21-day cycles.
1045541|NCT00706355|E4|Reported Event|PF-04217903 150 mg|One tablet 125 mg and 1 tablet 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045542|NCT00706355|E3|Reported Event|PF-04217903 200 mg|One tablet 125 mg and 3 tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045543|NCT00706355|E2|Reported Event|PF-04217903 100 mg|Four tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045544|NCT00706355|E1|Reported Event|PF-04217903 50 mg|Two tablets 25 mg PF-04217903 administered orally twice a day in continuous 21-day cycles.
1045545|NCT00706342|B1|Baseline|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
1045546|NCT00706342|P1|Participant Flow|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
1045547|NCT00706342|O1|Outcome|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
1045548|NCT00706342|O1|Outcome|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
1045549|NCT00706342|O1|Outcome|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
1045550|NCT00706342|O1|Outcome|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
1045551|NCT00706342|O1|Outcome|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
1045552|NCT00706342|O1|Outcome|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
1045553|NCT00706342|E1|Reported Event|R788 PO|Tablet containing 75mg BID to 225mg BID R788.
1045554|NCT00706329|B1|Baseline|Deflux|Treatment with Deflux.
1045555|NCT00706329|P1|Participant Flow|Deflux|Treatment with Deflux.
1045556|NCT00706329|O1|Outcome|Close Belly Button or Umbilical Hernia|
1045557|NCT00706329|E1|Reported Event|Deflux|Treatment with Deflux.
1045558|NCT00706134|B5|Baseline|Total|Total of all reporting groups
1045559|NCT00706134|B4|Baseline|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
1045560|NCT00706134|B3|Baseline|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
1045561|NCT00706134|B2|Baseline|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
1045562|NCT00706134|B1|Baseline|Placebo|Placebo tablet taken once daily in the morning with a light meal.
1045563|NCT00706134|P4|Participant Flow|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
1045564|NCT00706134|P3|Participant Flow|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
1045565|NCT00706134|P2|Participant Flow|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
1045566|NCT00706134|P1|Participant Flow|Placebo|Placebo tablet taken once daily in the morning with a light meal.
1045567|NCT00706134|O4|Outcome|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
1045568|NCT00706134|O3|Outcome|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
1045569|NCT00706134|O2|Outcome|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
1045570|NCT00706134|O1|Outcome|Placebo|Placebo tablet taken once daily in the morning with a light meal.
1045571|NCT00706134|O4|Outcome|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
1045583|NCT00706134|O4|Outcome|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
1045584|NCT00706134|O3|Outcome|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
1045585|NCT00706134|O2|Outcome|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
1045586|NCT00706134|O1|Outcome|Placebo|Placebo tablet taken once daily in the morning with a light meal.
1045587|NCT00706134|O4|Outcome|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
1045588|NCT00706134|O3|Outcome|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
1045589|NCT00706134|O2|Outcome|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
1045590|NCT00706134|O1|Outcome|Placebo|Placebo tablet taken once daily in the morning with a light meal.
1045591|NCT00706134|E4|Reported Event|Aliskiren 300 mg|Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
1045592|NCT00706134|E3|Reported Event|Aliskiren 150 mg|Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
1045593|NCT00706134|E2|Reported Event|Aliskiren 75 mg|Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
1045594|NCT00706134|E1|Reported Event|Placebo|Placebo tablet taken once daily in the morning with a light meal.
1045595|NCT00706121|B5|Baseline|Total|Total of all reporting groups
1045596|NCT00706121|B4|Baseline|Vitamin E Placebo + Selenium Placebo|"Vitamin E placebo and selenium placebo daily for 7 - 12 years~Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years~selenium placebo: 1 pill by mouth daily for 7 - 12 years"
1045597|NCT00706121|B3|Baseline|Vitamin E + Selenium|"Vitamin E and selenium daily for 7 - 12 years~Vitamin E: 400 IU daily by mouth for 7 - 12 years~Selenium: 200 mcg daily for 7 - 12 years"
1045598|NCT00706121|B2|Baseline|Selenium + Vitamin E Placebo|"Selenium and vitamin E placebo daily for 7 - 12 years~Selenium: 200 mcg daily for 7 - 12 years~Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years"
1045599|NCT00706121|B1|Baseline|Vitamin E + Selenium Placebo|"Vitamin E and selenium placebo daily for 7 - 12 years~Vitamin E: 400 IU daily by mouth for 7 - 12 years~selenium placebo: 1 pill by mouth daily for 7 - 12 years"
1045600|NCT00706121|P4|Participant Flow|Vitamin E Placebo + Selenium Placebo|"Vitamin E placebo and selenium placebo daily for 7 - 12 years~Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years~selenium placebo: 1 pill by mouth daily for 7 - 12 years"
1045601|NCT00706121|P3|Participant Flow|Vitamin E + Selenium|"Vitamin E and selenium daily for 7 - 12 years~Vitamin E: 400 IU daily by mouth for 7 - 12 years~Selenium: 200 mcg daily for 7 - 12 years"
1045602|NCT00706121|P2|Participant Flow|Selenium + Vitamin E Placebo|"Selenium and vitamin E placebo daily for 7 - 12 years~Selenium: 200 mcg daily for 7 - 12 years~Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years"
1045603|NCT00706121|P1|Participant Flow|Vitamin E + Selenium Placebo|"Vitamin E and selenium placebo daily for 7 - 12 years~Vitamin E: 400 IU daily by mouth for 7 - 12 years~selenium placebo: 1 pill by mouth daily for 7 - 12 years"
1045604|NCT00706121|O2|Outcome|Vitamin E Placebo|Vitamin E placebo +/- selenium
1045605|NCT00706121|O1|Outcome|Active Vitamin E|Active vitamin E +/- selenium
1045606|NCT00706121|O2|Outcome|Vitamin E Placebo|Vitamin E placebo +/- selenium
1045607|NCT00706121|O1|Outcome|Active Vitamin E|Active vitamin E +/- selenium
1045608|NCT00706121|O2|Outcome|Selenium Placebo|Selenium placebo +/- vitamin E
1045609|NCT00706121|O1|Outcome|Active Selenium|Active selenium +/- vitamin E
1045610|NCT00706121|O2|Outcome|Selenium Placebo|Selenium placebo +/- vitamin E
1045611|NCT00706121|O1|Outcome|Active Selenium|Active selenium +/- vitamin E
1045612|NCT00706121|O2|Outcome|Vitamin E Placebo|Vitamin E placebo +/- selenium
1045613|NCT00706121|O1|Outcome|Active Vitamin E|Active vitamin E +/- selenium
1045614|NCT00706121|O2|Outcome|Selenium Placebo|Selenium placebo +/- vitamin E
1045615|NCT00706121|O1|Outcome|Active Selenium|Active selenium +/- vitamin E
1045616|NCT00706121|O4|Outcome|Placebo|Matching placebo for vitamin E + matching placebo for selenium
1045617|NCT00706121|O3|Outcome|Combination|Vitamin E + selenium
1045618|NCT00706121|O2|Outcome|Selenium|Selenium + matching placebo for vitamin E
1045619|NCT00706121|O1|Outcome|Vitamin E|Vitamin E + matching placebo for selenium
1045620|NCT00706121|O2|Outcome|Selenium Placebo|Selenium placebo +/- Vitamin E
1045621|NCT00706121|O1|Outcome|Active Selenium|Active selenium +/- Vitamin E
1045622|NCT00706121|O2|Outcome|Selenium Placebo|Selenium Placebo +/- Vitamin E
1045623|NCT00706121|O1|Outcome|Active Selenium|Active Selenium +/- Vitamin E
1045624|NCT00706121|E4|Reported Event|Vitamin E Placebo + Selenium Placebo|"Vitamin E placebo and selenium placebo daily for 7 - 12 years~Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years~selenium placebo: 1 pill by mouth daily for 7 - 12 years"
1045625|NCT00706121|E3|Reported Event|Vitamin E + Selenium|"Vitamin E and selenium daily for 7 - 12 years~Vitamin E: 400 IU daily by mouth for 7 - 12 years~Selenium: 200 mcg daily for 7 - 12 years"
1045626|NCT00706121|E2|Reported Event|Selenium + Vitamin E Placebo|"Selenium and vitamin E placebo daily for 7 - 12 years~Selenium: 200 mcg daily for 7 - 12 years~Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years"
1045627|NCT00706121|E1|Reported Event|Vitamin E + Selenium Placebo|"Vitamin E and selenium placebo daily for 7 - 12 years~Vitamin E: 400 IU daily by mouth for 7 - 12 years~selenium placebo: 1 pill by mouth daily for 7 - 12 years"
1045628|NCT00706095|B4|Baseline|Total|Total of all reporting groups
1045629|NCT00706095|B3|Baseline|E7389 0.7 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
1045630|NCT00706095|B2|Baseline|E7389 1.1 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
1045631|NCT00706095|B1|Baseline|E7389 1.4 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
1045632|NCT00706095|P3|Participant Flow|E7389 0.7 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
1045633|NCT00706095|P2|Participant Flow|E7389 1.1 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
1045634|NCT00706095|P1|Participant Flow|E7389 1.4 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
1045635|NCT00706095|O3|Outcome|E7389 0.7 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
1045636|NCT00706095|O2|Outcome|E7389 1.1 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
1045637|NCT00706095|O1|Outcome|E7389 1.4 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
1045638|NCT00706095|O3|Outcome|E7389 0.7 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
1045639|NCT00706095|O2|Outcome|E7389 1.1 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
1045640|NCT00706095|O1|Outcome|E7389 1.4 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
1045641|NCT00706095|O3|Outcome|E7389 0.7 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
1045642|NCT00706095|O2|Outcome|E7389 1.1 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
1045643|NCT00706095|O1|Outcome|E7389 1.4 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
1045644|NCT00706095|E3|Reported Event|E7389 0.7 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
1045645|NCT00706095|E2|Reported Event|E7389 1.1 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
1045646|NCT00706095|E1|Reported Event|E7389 1.4 mg/m^2|E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
1045647|NCT00706004|B1|Baseline|Lubiprostone|24 micrograms twice daily
1045648|NCT00706004|P1|Participant Flow|Lubiprostone|24 micrograms twice daily
1045649|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
1045650|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
1045651|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
1045652|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
1045653|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
1045654|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
1045655|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
1045656|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
1045657|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
1045658|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
1045659|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
1045660|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
1045661|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
1045662|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
1045663|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
1045664|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
1045665|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
1045666|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|
1045667|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|
1045668|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|
1045669|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|
1045670|NCT00706004|O1|Outcome|Lubiprostone 24 Mcg Twice Daily|Participants served as their own controls
1045671|NCT00706004|E1|Reported Event|Lubiprostone|24 micrograms twice daily
1045672|NCT00705939|B4|Baseline|Total|Total of all reporting groups
1045673|NCT00705939|B3|Baseline|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose
1045674|NCT00705939|B2|Baseline|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy from Study PB-06-001 treated with taliglucerase alfa 60 units/kg
1045675|NCT00705939|B1|Baseline|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
1045676|NCT00705939|P3|Participant Flow|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose
1045677|NCT00705939|P2|Participant Flow|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy from Study PB-06-001 treated with taliglucerase alfa 60 units/kg
1045678|NCT00705939|P1|Participant Flow|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
1045679|NCT00705939|O3|Outcome|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose
1045680|NCT00705939|O2|Outcome|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 60 units/kg
1045681|NCT00705939|O1|Outcome|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
1045682|NCT00705939|O3|Outcome|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose
1045683|NCT00705939|O2|Outcome|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 60 units/kg
1045684|NCT00705939|O1|Outcome|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
1045985|NCT00705432|B7|Baseline|Total|Total of all reporting groups
1045685|NCT00705939|O3|Outcome|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose.
1045686|NCT00705939|O2|Outcome|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 60 units/kg
1045687|NCT00705939|O1|Outcome|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
1045688|NCT00705939|O3|Outcome|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose.
1045689|NCT00705939|O2|Outcome|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 60 units/kg
1045690|NCT00705939|O1|Outcome|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
1045691|NCT00705939|O3|Outcome|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose.
1045692|NCT00705939|O2|Outcome|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 60 units/kg
1045693|NCT00705939|O1|Outcome|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
1045694|NCT00705939|O3|Outcome|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose.
1045695|NCT00705939|O2|Outcome|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 60 units/kg
1045696|NCT00705939|O1|Outcome|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
1045697|NCT00705939|E3|Reported Event|Switchover|Patients previously treated with imiglucerase in Study PB-06-002 treated with taliglucerase alfa at the same dose as their previous imiglucerase dose
1045698|NCT00705939|E2|Reported Event|Naive 60 Units/kg|Patients previously naive to enzyme replacement therapy from Study PB-06-001 treated with taliglucerase alfa 60 units/kg
1045699|NCT00705939|E1|Reported Event|Naive 30 Units/kg|Patients previously naive to enzyme replacement therapy treated in Study PB-06-001 with taliglucerase alfa 30 units/kg
1045700|NCT00705874|B8|Baseline|Total|Total of all reporting groups
1045701|NCT00705874|B7|Baseline|PG11047/Sunitinib|PG-11047 (infusion on Days 1 and 8 of a 21 day cycle) in combination with Sunitinib (50 mg orally once daily, 4 weeks on treatment followed by 2 weeks off (42 day cycle)).
1045702|NCT00705874|B6|Baseline|PG11047/5-Flurouracil|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with 5-Flurouracil / Leucovorin (Leucovorin 500 mg/m2 IV over 2 hours with 5 - FU 500 mg/m2 IV bolus starting 1 hour into leucovorin infusion weekly for 6 weeks, repeated every 56 days).
1045703|NCT00705874|B5|Baseline|PG11047/Cisplatin|Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. PG-11047 will be administered by infusion on Days 1, 8 and 15 of a 28 day cycle.
1045704|NCT00705874|B4|Baseline|PG11047/Erlotinib|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Erlotinib (150 mg taken orally every day of each 28-day cycle).
1045705|NCT00705874|B3|Baseline|PG11047/Bevacizumab|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Bevacizumab (5 mg/kg administered IV once every 14 days).
1045706|NCT00705874|B2|Baseline|PG11047/Docetaxel|PG-11047 (infusion on Day 1 of each 21 day cycle) in combination with Docetaxel (75 mg/m2 administered IV over 60 minutes every 21 days).
1045707|NCT00705874|B1|Baseline|PG11047/Gemcitabine|PG-11047 (infusion on Days 1 and 15 of each cycle) in combination with Gemcitabine (1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle).
1045708|NCT00705874|P7|Participant Flow|PG11047/Sunitinib|PG-11047 (infusion on Days 1 and 8 of a 21 day cycle) in combination with Sunitinib (50 mg orally once daily, 4 weeks on treatment followed by 2 weeks off (42 day cycle)).
1045709|NCT00705874|P6|Participant Flow|PG11047/5-Flurouracil|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with 5-Flurouracil / Leucovorin (Leucovorin 500 mg/m2 IV over 2 hours with 5 - FU 500 mg/m2 IV bolus starting 1 hour into leucovorin infusion weekly for 6 weeks, repeated every 56 days).
1045710|NCT00705874|P5|Participant Flow|PG11047/Cisplatin|Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. PG-11047 will be administered by infusion on Days 1, 8 and 15 of a 28 day cycle.
1045711|NCT00705874|P4|Participant Flow|PG11047/Erlotinib|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Erlotinib (150 mg taken orally every day of each 28-day cycle).
1045712|NCT00705874|P3|Participant Flow|PG11047/Bevacizumab|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Bevacizumab (5 mg/kg administered IV once every 14 days).
1045713|NCT00705874|P2|Participant Flow|PG11047/Docetaxel|PG-11047 (infusion on Day 1 of each 21 day cycle) in combination with Docetaxel (75 mg/m2 administered IV over 60 minutes every 21 days).
1045714|NCT00705874|P1|Participant Flow|PG11047/Gemcitabine|PG-11047 (infusion on Days 1 and 15 of each cycle) in combination with Gemcitabine (1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle).
1045715|NCT00705874|O7|Outcome|PG11047/Sunitinib|"PG-11047 in combination with Sunitinib.~The MTD of PG-11047 was undetermineable due to only 2 evaluable patients in this treatment group"
1045716|NCT00705874|O6|Outcome|PG11047/5-Flurouracil|CGC-11047 in combination with 5-Flurouracil / Leucovorin
1045717|NCT00705874|O5|Outcome|PG11047/Cisplatin|Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. PG-11047 will be administered on Days 1, 8 and 15 of a 28 day cycle.
1045718|NCT00705874|O4|Outcome|PG11047/Erlotinib|PG-11047 in combination with Erlotinib
1045719|NCT00705874|O3|Outcome|PG11047/Bevacizumab|PG-11047 in combination with Bevacizumab
1045720|NCT00705874|O2|Outcome|PG11047/Docetaxel|PG-11047 in combination with Docetaxel
1045721|NCT00705874|O1|Outcome|PG11047/Gemcitabine|PG-11047 in combination with Gemcitabine
1045722|NCT00705874|E7|Reported Event|PG11047/Sunitinib|PG-11047 (infusion on Days 1 and 8 of a 21 day cycle) in combination with Sunitinib (50 mg orally once daily, 4 weeks on treatment followed by 2 weeks off (42 day cycle)).
1045723|NCT00705874|E6|Reported Event|PG11047/5-Flurouracil|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with 5-Flurouracil / Leucovorin (Leucovorin 500 mg/m2 IV over 2 hours with 5 - FU 500 mg/m2 IV bolus starting 1 hour into leucovorin infusion weekly for 6 weeks, repeated every 56 days).
1045724|NCT00705874|E5|Reported Event|PG11047/Cisplatin|Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. PG-11047 will be administered by infusion on Days 1, 8 and 15 of a 28 day cycle.
1045725|NCT00705874|E4|Reported Event|PG11047/Erlotinib|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Erlotinib (150 mg taken orally every day of each 28-day cycle).
1045726|NCT00705874|E3|Reported Event|PG11047/Bevacizumab|PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Bevacizumab (5 mg/kg administered IV once every 14 days).
1045727|NCT00705874|E2|Reported Event|PG11047/Docetaxel|PG-11047 (infusion on Day 1 of each 21 day cycle) in combination with Docetaxel (75 mg/m2 administered IV over 60 minutes every 21 days).
1045728|NCT00705874|E1|Reported Event|PG11047/Gemcitabine|PG-11047 (infusion on Days 1 and 15 of each cycle) in combination with Gemcitabine (1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle).
1045729|NCT00705783|B3|Baseline|Total|Total of all reporting groups
1045730|NCT00705783|B2|Baseline|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
1045731|NCT00705783|B1|Baseline|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
1045732|NCT00705783|P3|Participant Flow|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
1045733|NCT00705783|P2|Participant Flow|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
1045734|NCT00705783|P1|Participant Flow|All Patients|During the Conversion Phase, patients were cross-titrated from other antipsychotics to oral non-generic aripiprazole monotherapy. During the Oral Stabilization Phase, patients were stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily. During the Depot Stabilization Phase, patients were stabilized on aripiprazole depot.
1045735|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
1045736|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
1045737|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
1045738|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
1045739|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
1045740|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
1045741|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
1045742|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
1045743|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
1045744|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
1045745|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
1045746|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
1045747|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
1045748|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
1045749|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
1045750|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
1045751|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
1045752|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
1045753|NCT00705783|O2|Outcome|Placebo Depot|Patients received placebo intramuscularly every 28 days for 52 weeks.
1045754|NCT00705783|O1|Outcome|Aripiprazole Depot|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
1045755|NCT00705783|E5|Reported Event|Placebo Depot - Depot Maintenance Phase|Patients received placebo intramuscularly every 28 days for 52 weeks.
1045756|NCT00705783|E4|Reported Event|Aripiprazole Depot - Depot Maintenance Phase|Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
1045757|NCT00705783|E3|Reported Event|Depot Stabilization Phase|During the IM Depot Stabilization Phase, patients were stabilized on aripiprazole IM depot.
1045758|NCT00705783|E2|Reported Event|Oral Stabilization Phase|During the Oral Stabilization Phase, patients were stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily.
1045759|NCT00705783|E1|Reported Event|Conversion Phase|During the Conversion Phase, patients were cross-titrated from other antipsychotics to oral non-generic aripiprazole monotherapy.
1045760|NCT00705757|B4|Baseline|Total|Total of all reporting groups
1045761|NCT00705757|B3|Baseline|Travatan|Participants were assigned to use Travatan/travoprost 0.004% ophthalmic sol., one drop qhs for one year in affected eye(s)
1045762|NCT00705757|B2|Baseline|Xalatan|Participants were assigned to use Xalatan/latanoprost 0.005% ophthalmic sol. one drop qhs for one year in affected eye(s)
1045763|NCT00705757|B1|Baseline|Lumigan|Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s)
1045764|NCT00705757|P3|Participant Flow|Travatan|Participants were assigned to use Travatan/travoprost 0.004% ophthalmic sol., one drop qhs for one year in affected eye(s)
1045765|NCT00705757|P2|Participant Flow|Xalatan|Participants were assigned to use Xalatan/latanoprost 0.005% ophthalmic sol. one drop qhs for one year in affected eye(s)
1045766|NCT00705757|P1|Participant Flow|Lumigan|Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s)
1045767|NCT00705757|O3|Outcome|Travatan|Participants were assigned to use Travatan ophthalmic solution one drop qhs for one year in affected eye(s).
1045768|NCT00705757|O2|Outcome|Xalatan|Participants were assigned to use Xalatan ophthalmic solution one drop qhs for one year in affected eye(s).
1045769|NCT00705757|O1|Outcome|Lumigan|Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s).
1045770|NCT00705757|E3|Reported Event|Travatan|Participants were assigned to use Travatan/travoprost 0.004% ophthalmic sol., one drop qhs for one year in affected eye(s)
1045771|NCT00705757|E2|Reported Event|Xalatan|Participants were assigned to use Xalatan/latanoprost 0.005% ophthalmic sol. one drop qhs for one year in affected eye(s)
1045772|NCT00705757|E1|Reported Event|Lumigan|Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s)
1045773|NCT00705718|B3|Baseline|Total|Total of all reporting groups
1045774|NCT00705718|B2|Baseline|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
1045775|NCT00705718|B1|Baseline|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
1045776|NCT00705718|P2|Participant Flow|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
1045777|NCT00705718|P1|Participant Flow|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
1045778|NCT00705718|O2|Outcome|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
1045779|NCT00705718|O1|Outcome|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
1045780|NCT00705718|O2|Outcome|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
1045781|NCT00705718|O1|Outcome|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
1045782|NCT00705718|O2|Outcome|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
1045783|NCT00705718|O1|Outcome|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
1045784|NCT00705718|O2|Outcome|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
1045785|NCT00705718|O1|Outcome|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
1045786|NCT00705718|O2|Outcome|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
1045787|NCT00705718|O1|Outcome|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
1045788|NCT00705718|O2|Outcome|Endurant Bifurcated Arm|Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
1045789|NCT00705718|O1|Outcome|Endurant AUI Arm|Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
1045790|NCT00705718|E2|Reported Event|2. Endurant Bifurcated Arm|Endurant Stent Graft System - Endurant Bifurcated arm
1045791|NCT00705718|E1|Reported Event|1. Endurant AUI Arm|Endurant Stent Graft System - Endurant AUI arm
1045792|NCT00705679|B6|Baseline|Total|Total of all reporting groups
1045793|NCT00705679|B5|Baseline|Gel Placebo|"Application of tenofovir placebo gel once daily~Tenofovir placebo: placebo gel"
1045794|NCT00705679|B4|Baseline|TFV Gel|"Application of tenofovir 1% vaginal gel once daily~Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel"
1045795|NCT00705679|B3|Baseline|Oral Placebo|"TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
1045796|NCT00705679|B2|Baseline|Oral TDF-FTC|"TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
1045797|NCT00705679|B1|Baseline|Oral TDF|"TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate: 300 mg tablet"
1045798|NCT00705679|P5|Participant Flow|Gel Placebo|"Application of tenofovir placebo gel once daily~Tenofovir placebo: placebo gel"
1045799|NCT00705679|P4|Participant Flow|TFV Gel|"Application of tenofovir 1% vaginal gel once daily~Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel"
1045800|NCT00705679|P3|Participant Flow|Oral Placebo|"TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
1045801|NCT00705679|P2|Participant Flow|Oral TDF-FTC|"TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
1045802|NCT00705679|P1|Participant Flow|Oral TDF|"TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate: 300 mg tablet"
1045803|NCT00705679|O5|Outcome|Gel Placebo|"Application of tenofovir placebo gel once daily~Tenofovir placebo: placebo gel"
1045804|NCT00705679|O4|Outcome|TFV Gel|"Application of tenofovir 1% vaginal gel once daily~Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel"
1045805|NCT00705679|O3|Outcome|Oral Placebo|"TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
1045806|NCT00705679|O2|Outcome|Oral TDF-FTC|"TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
1045807|NCT00705679|O1|Outcome|Oral TDF|"TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate: 300 mg tablet"
1045808|NCT00705679|O2|Outcome|Oral Placebo|TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet
1045809|NCT00705679|O1|Outcome|Oral TDF-FTC|TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet Tenofovir disoproxil fumarate placebo: placebo tablet
1045810|NCT00705679|O2|Outcome|Oral Placebo|TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet
1045811|NCT00705679|O1|Outcome|Oral TDF-FTC|TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet Tenofovir disoproxil fumarate placebo: placebo tablet
1045812|NCT00705679|O2|Outcome|Oral Placebo|TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet
1045813|NCT00705679|O1|Outcome|Oral TDF-FTC|TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet Tenofovir disoproxil fumarate placebo: placebo tablet
1045814|NCT00705679|O2|Outcome|Oral Placebo|TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet
1045815|NCT00705679|O1|Outcome|Oral TDF|TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate: 300 mg tablet
1045816|NCT00705679|O2|Outcome|Oral Placebo|TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet
1045817|NCT00705679|O1|Outcome|Oral TDF|TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate: 300 mg tablet
1045818|NCT00705679|O2|Outcome|Oral Placebo|TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate placebo: placebo tablet
1045819|NCT00705679|O1|Outcome|Oral TDF|TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet Tenofovir disoproxil fumarate: 300 mg tablet
1045820|NCT00705679|O2|Outcome|Placebo Gel|Application of placebo gel once daily Tenofovir placebo gel: placebo gel
1045821|NCT00705679|O1|Outcome|TFV Gel|Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel
1045822|NCT00705679|O5|Outcome|Gel Placebo|"Application of tenofovir placebo gel once daily~Tenofovir placebo: placebo gel"
1045823|NCT00705679|O4|Outcome|TFV Gel|"Application of tenofovir 1% vaginal gel once daily~Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel"
1045824|NCT00705679|O3|Outcome|Oral Placebo|"TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
1045825|NCT00705679|O2|Outcome|Oral TDF-FTC|"TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
1045826|NCT00705679|O1|Outcome|Oral TDF|"TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate: 300 mg tablet"
1045827|NCT00705679|O2|Outcome|Placebo Gel|Application of placebo gel once daily Tenofovir placebo gel: placebo gel
1045828|NCT00705679|O1|Outcome|TFV Gel|Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel
1045829|NCT00705679|O2|Outcome|Placebo Gel|Application of placebo gel once daily Tenofovir placebo gel: placebo gel
1045830|NCT00705679|O1|Outcome|TFV Gel|Application of tenofovir 1% vaginal gel once daily Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel
1045831|NCT00705679|E5|Reported Event|Gel Placebo|"Application of tenofovir placebo gel once daily~Tenofovir placebo: placebo gel"
1045832|NCT00705679|E4|Reported Event|TFV Gel|"Application of tenofovir 1% vaginal gel once daily~Tenofovir 1% vaginal gel: 1 gm/100 ml of 1% gel"
1045833|NCT00705679|E3|Reported Event|Oral Placebo|"TDF placebo tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
1045834|NCT00705679|E2|Reported Event|Oral TDF-FTC|"TDF placebo tablet taken orally once daily and one FTC 200 mg/TDF 300 mg tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate: 200 mg/300 mg tablet~Tenofovir disoproxil fumarate placebo: placebo tablet"
1045835|NCT00705679|E1|Reported Event|Oral TDF|"TDF 300 mg tablet taken orally once daily and one FTC/TDF placebo tablet taken orally once daily for 12 to 36 months~Emtricitabine/tenofovir disoproxil fumarate placebo: placebo tablet~Tenofovir disoproxil fumarate: 300 mg tablet"
1045836|NCT00705666|B1|Baseline|PegIntron as Monotherapy or in Combination With Ribavirin|Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin.
1045837|NCT00705666|P1|Participant Flow|PegIntron as Monotherapy or in Combination With Ribavirin|Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin.
1045838|NCT00705666|O1|Outcome|PegIntron as Monotherapy or in Combination With Ribavirin|"Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin.~The recommended treatment duration was 24 weeks for genotypes 2 and 3 and 48 weeks for genotype 1 according to the French 2002 consensus meeting.~The start and end dates of the treatment were collected in the questionnaire, so the actual treatment duration was calculated for each participant and compared to the theoretical treatment duration reported at Day 0 by the investigators."
1045839|NCT00705666|E1|Reported Event|PegIntron as Monotherapy or in Combination With Ribavirin|
1045840|NCT00705653|B1|Baseline|PG-11047|Multiple-ascending dose of PG-11047 monotherapy. 60 minute infusion on days 1, 8 and 15 of a 28 day cycle. Dosage was escalated from 50 mg to 750 mg
1045841|NCT00705653|P1|Participant Flow|PG-11047|Multiple-ascending dose of PG-11047 monotherapy. 60 minute infusion on days 1, 8 and 15 of a 28 day cycle. Dosage was escalated from 50 mg to 750 mg
1045842|NCT00705653|O1|Outcome|PG-11047|Multiple-ascending dose of PG-11047 monotherapy. 60 minute infusion on days 1, 8 and 15 of a 28 day cycle. Dosage was escalated from 50 mg to 750 mg
1045843|NCT00705653|O1|Outcome|PG-11047|Multiple-ascending dose of PG-11047 monotherapy. 60 minute infusion on days 1, 8 and 15 of a 28 day cycle. Dosage was escalated from 50 mg to 750 mg
1045844|NCT00705653|E1|Reported Event|PG-11047|Multiple-ascending dose of PG-11047 monotherapy. 60 minute infusion on days 1, 8 and 15 of a 28 day cycle. Dosage was escalated from 50 mg to 750 mg
1045845|NCT00705614|B3|Baseline|Total|Total of all reporting groups
1045846|NCT00705614|B2|Baseline|Standard Therapy Group|The Standard Therapy group includes both those who stayed on Standard Therapy and those who switched to Remicade after starting on Standard Therapy. Two hundred ninety-eight of the 1121 subjects enrolled in the Standard Therapy Group switched to Remicade during follow-up.
1045847|NCT00705614|B1|Baseline|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit. The treating physician will determine the treatment regimen and dose of Remicade.
1045848|NCT00705614|P2|Participant Flow|Standard Therapy Group|"Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.~Some participants who start in the Standard Therapy Group switched over to Remicade sometime during the follow-up period. Participants who switched to Remicade were evaluated in the Standard Therapy group until the time of the switch and were evaluated in the Switched to Remicade group thereafter."
1045849|NCT00705614|P1|Participant Flow|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit. The treating physician will determine the treatment regimen and dose of Remicade.
1045850|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
1045851|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
1045852|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
1045853|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
1045854|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
1045855|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
1045856|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
1045857|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
1045858|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
1045859|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
1045860|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
1045861|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
1045862|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
1045863|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
1045864|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
1045865|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
1045866|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
1045867|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
1045868|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
1045869|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
1045870|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
1045871|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
1045872|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
1045873|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
1045874|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
1045875|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
1045876|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
1045877|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
1045878|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
1045879|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
1045880|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
1045881|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
1045882|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
1045883|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
1045884|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
1045885|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
1045886|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
1045887|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
1045888|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
1045889|NCT00705614|O3|Outcome|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
1045890|NCT00705614|O2|Outcome|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
1045891|NCT00705614|O1|Outcome|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
1045892|NCT00705614|E3|Reported Event|Switched to Remicade|Participants who started in the Standard Therapy Group but switched over to Remicade during the study.
1045893|NCT00705614|E2|Reported Event|Remicade|Participants with no prior exposure to Remicade, who at the time of enrollment, were scheduled to receive Remicade within 30 days of the enrollment visit.
1045894|NCT00705614|E1|Reported Event|Standard Therapy|Participants who were treated with conventional therapies and who were adequately maintained were offered an alternative treatment that did not include Remicade. These participants must not have received treatment with Remicade prior to enrollment.
1045895|NCT00705575|B3|Baseline|Total|Total of all reporting groups
1045896|NCT00705575|B2|Baseline|Aliskiren (300 mg)|During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
1045897|NCT00705575|B1|Baseline|Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)|During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
1045898|NCT00705575|P2|Participant Flow|Aliskiren (300 mg)|During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
1045899|NCT00705575|P1|Participant Flow|Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)|During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
1045900|NCT00705575|O2|Outcome|Aliskiren (300 mg)|During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
1045901|NCT00705575|O1|Outcome|Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)|During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
1045902|NCT00705575|O2|Outcome|Aliskiren (300 mg)|During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
1045903|NCT00705575|O1|Outcome|Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)|During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
1045904|NCT00705575|O2|Outcome|Aliskiren (300 mg)|During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
1045905|NCT00705575|O1|Outcome|Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)|During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
1045906|NCT00705575|O2|Outcome|Aliskiren (300 mg)|During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
1045907|NCT00705575|O1|Outcome|Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)|During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
1045908|NCT00705575|E2|Reported Event|Aliskiren (300 mg)|During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
1045909|NCT00705575|E1|Reported Event|Aliskiren/Hydrochlorothiazide (HCTZ) (300/25 mg)|During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week. Subsequently, patients were up-titrated and received aliskiren/HCTZ 300/25 mg.
1045910|NCT00705536|B3|Baseline|Total|Total of all reporting groups
1045911|NCT00705536|B2|Baseline|Stage 2: Humulin-R Alone or Humulin-R + rHuPH20|Participants randomized to treatment with a single subcutaneous (SC) injection of 20 units (U) Humulin-R alone or 20 U Humulin-R + 240 U recombinant human hyaluronidase (rHuPH20), followed by crossover treatment after a washout period of at least 6 days.
1045912|NCT00705536|B1|Baseline|Stage 1: Humalog Alone or Humalog + rHuPH20|Participants randomized to treatment with a single subcutaneous (SC) injection of 20 units (U) Humalog alone or 20 U Humalog + 300 U recombinant human hyaluronidase (rHuPH20), followed by crossover treatment after a washout period of at least 6 days.
1045913|NCT00705536|P4|Participant Flow|Stage 2: Humulin-R + rHuPH20 First, Then Humulin-R|Stage 2 of the study. A single subcutaneous (SC) injection of 20 units (U) Humulin-R + 240 U recombinant human hyaluronidase PH20 (rHuPH20) on Day 1 of Stage 2, followed by a washout period of at least 6 days. Then, a single SC injection of 20 U Humulin-R alone.
1045914|NCT00705536|P3|Participant Flow|Stage 2: Humulin-R First, Then Humulin-R + rHuPH20|Stage 2 of the study: A single subcutaneous (SC) injection of 20 units (U) Humulin-R alone on Day 1 of Stage 2, followed by a washout period of at least 6 days. Then, a single SC injection of 20 U Humulin-R + 240 U recombinant human hyaluronidase PH20 (rHuPH20).
1045915|NCT00705536|P2|Participant Flow|Stage 1: Humalog + rHuPH20 First, Then Humalog|Stage 1 of the study: A single subcutaneous (SC) injection of 20 units (U) Humalog + 300 U recombinant human hyaluronidase PH20 (rHuPH20) on Day 1 of Stage 1, followed by a washout period of at least 6 days. Then, a single SC injection of 20 U Humalog alone.
1045916|NCT00705536|P1|Participant Flow|Stage 1: Humalog First, Then Humalog + rHuPH20|Stage 1 of the study: A single subcutaneous (SC) injection of 20 units (U) Humalog alone on Day 1 of Stage 1, followed by a washout period of at least 6 days. Then, a single SC injection of 20 U Humalog + 300 U recombinant human hyaluronidase PH20 (rHuPH20).
1045917|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
1045918|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin: A single subcutaneous (SC) injection of 20 units (U)
1045919|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
1045920|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
1045921|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
1045922|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
1045923|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
1045924|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
1045925|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
1045926|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
1045927|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
1045928|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
1045929|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
1045930|NCT00705536|O3|Outcome|Stage 2: Humulin Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
1045931|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
1045932|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
1045933|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
1045934|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
1045935|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
1045936|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
1045937|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
1045938|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
1045939|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
1046362|NCT00704418|E2|Reported Event|Placebo|Placebo, dosed 1 drop daily
1045940|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
1045941|NCT00705536|O2|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) of Humulin-R and 240 U of rHuPH20
1045942|NCT00705536|O1|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) of Humalog and 300 U of rHuPH20
1045943|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
1045944|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
1045945|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
1045946|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
1045947|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
1045948|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
1045949|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
1045950|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
1045951|NCT00705536|O3|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
1045952|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
1045953|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
1045954|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
1045955|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
1045956|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20) : A single subcutaneous (SC) injection of 20 units (U) Humalog + 300 U rHuPH20
1045957|NCT00705536|O1|Outcome|Stage 1. Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
1045958|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
1045959|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
1045960|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
1045961|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
1045962|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
1045963|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
1045964|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
1045965|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
1045966|NCT00705536|O4|Outcome|Stage 2: Humulin-R + rHuPH20|Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20
1045967|NCT00705536|O3|Outcome|Stage 2: Humulin-R Alone|Humulin-R: A single subcutaneous (SC) injection of 20 units (U)
1045968|NCT00705536|O2|Outcome|Stage 1: Humalog + rHuPH20|Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20
1045969|NCT00705536|O1|Outcome|Stage 1: Humalog Alone|Humalog: A single subcutaneous (SC) injection of 20 units (U)
1045970|NCT00705536|E4|Reported Event|Stage 2: Humulin-R + rHuPH20|Participants randomized to treatment with a single subcutaneous (SC) injection of 20 units (U) Humulin-R + 240 U recombinant human hyaluronidase (rHuPH20) during Stage 2 of the study
1045971|NCT00705536|E3|Reported Event|Stage 2: Humulin-R Alone|Participants randomized to treatment with a single subcutaneous (SC) injection of 20 units (U) Humulin-R alone during Stage 2 of the study
1045972|NCT00705536|E2|Reported Event|Stage 1: Humalog + rHuPH20|Participants randomized to treatment with a single subcutaneous (SC) injection of 20 units (U) Humalog + 300 U recombinant human hyaluronidase (rHuPH20) during Stage 1 of the study
1045973|NCT00705536|E1|Reported Event|Stage 1: Humalog Alone|Participants randomized to treatment with a single subcutaneous (SC) injection of 20 units (U) Humalog alone during Stage 1 of the study
1045974|NCT00705523|B3|Baseline|Total|Total of all reporting groups
1045975|NCT00705523|B2|Baseline|Placebo|placebo : BID 12 weeks
1045976|NCT00705523|B1|Baseline|Varenicline|Titrated 0.5mg o.d. for days 1-3, 0.5mg b.i.d. for days 4-7, up to full dose of 1 mg/day by the end of the first week. Then 1 mg/day for remaining weeks.
1045977|NCT00705523|P2|Participant Flow|Placebo|placebo : BID 12 weeks
1045978|NCT00705523|P1|Participant Flow|Varenicline|varenicline : 1.0 mg BID for 12 weeks
1045979|NCT00705523|O2|Outcome|Placebo|placebo : BID 12 weeks
1045980|NCT00705523|O1|Outcome|Varenicline|Titrated 0.5mg o.d. for days 1-3, 0.5mg b.i.d. for days 4-7, up to full dose of 1 mg/day by the end of the first week. Then 1 mg/day for remaining weeks.
1045981|NCT00705523|O2|Outcome|Placebo|placebo : BID 12 weeks
1045982|NCT00705523|O1|Outcome|Varenicline|Titrated 0.5mg o.d. for days 1-3, 0.5mg b.i.d. for days 4-7, up to full dose of 1 mg/day by the end of the first week. Then 1 mg/day for remaining weeks.
1045983|NCT00705523|E2|Reported Event|Placebo|placebo : BID 12 weeks
1045984|NCT00705523|E1|Reported Event|Varenicline|varenicline : 1.0 mg BID for 12 weeks
1045986|NCT00705432|B6|Baseline|Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1045987|NCT00705432|B5|Baseline|Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
1045988|NCT00705432|B4|Baseline|Cohort II - 1. Placebo + PEG + RBV|Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1045989|NCT00705432|B3|Baseline|Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1045990|NCT00705432|B2|Baseline|Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
1045991|NCT00705432|B1|Baseline|Cohort I - 1. Placebo + PEG + RBV|Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1045992|NCT00705432|P6|Participant Flow|Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1045993|NCT00705432|P5|Participant Flow|Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
1045994|NCT00705432|P4|Participant Flow|Cohort II - 1. Placebo + PEG + RBV|Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1045995|NCT00705432|P3|Participant Flow|Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1045996|NCT00705432|P2|Participant Flow|Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
1045997|NCT00705432|P1|Participant Flow|Cohort I - 1. Placebo + PEG + RBV|Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1045998|NCT00705432|O6|Outcome|Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1045999|NCT00705432|O5|Outcome|Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
1046000|NCT00705432|O4|Outcome|Cohort II - 1. Placebo + PEG + RBV|Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1046001|NCT00705432|O3|Outcome|Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1046038|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
1046039|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
1046040|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
1046002|NCT00705432|O2|Outcome|Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
1046003|NCT00705432|O1|Outcome|Cohort I - 1. Placebo + PEG + RBV|Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1046004|NCT00705432|O6|Outcome|Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1046005|NCT00705432|O5|Outcome|Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
1046006|NCT00705432|O4|Outcome|Cohort II - 1. Placebo + PEG + RBV|Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1046007|NCT00705432|O3|Outcome|Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1046008|NCT00705432|O2|Outcome|Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
1046009|NCT00705432|O1|Outcome|Cohort I - 1. Placebo + PEG + RBV|Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1046010|NCT00705432|O6|Outcome|Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1046011|NCT00705432|O5|Outcome|Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
1046012|NCT00705432|O4|Outcome|Cohort II - 1. Placebo + PEG + RBV|Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1046013|NCT00705432|O3|Outcome|Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1046014|NCT00705432|O2|Outcome|Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
1046015|NCT00705432|O1|Outcome|Cohort I - 1. Placebo + PEG + RBV|Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1046016|NCT00705432|O6|Outcome|Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1046041|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
1046042|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
1046043|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
1046044|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
1046045|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
1046017|NCT00705432|O5|Outcome|Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
1046018|NCT00705432|O4|Outcome|Cohort II - 1. Placebo + PEG + RBV|Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1046019|NCT00705432|O3|Outcome|Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1046020|NCT00705432|O2|Outcome|Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
1046021|NCT00705432|O1|Outcome|Cohort I - 1. Placebo + PEG + RBV|Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1046022|NCT00705432|O6|Outcome|Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1046023|NCT00705432|O5|Outcome|Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
1046024|NCT00705432|O4|Outcome|Cohort II - 1. Placebo + PEG + RBV|Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1046025|NCT00705432|O3|Outcome|Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks|Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1046026|NCT00705432|O2|Outcome|Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)|"Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
1046027|NCT00705432|O1|Outcome|Cohort I - 1. Placebo + PEG + RBV|Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1046028|NCT00705432|E3|Reported Event|BOCEPRIVIR + PEG + RBV - 44 WEEKS|Cohort I (White participants) and Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1046029|NCT00705432|E2|Reported Event|BOCEPREVIR + PEG + RBV - 24 WEEKS|"Cohort I (White participants) and Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.~At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.~At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up."
1046030|NCT00705432|E1|Reported Event|PEG + RBV|Cohort I (White participants) and Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
1046031|NCT00705406|B3|Baseline|Total|Total of all reporting groups
1046032|NCT00705406|B2|Baseline|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
1046033|NCT00705406|B1|Baseline|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
1046034|NCT00705406|P2|Participant Flow|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
1046035|NCT00705406|P1|Participant Flow|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
1046036|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
1046037|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
1046046|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
1046047|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
1046048|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection
1046049|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
1046050|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
1046051|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
1046052|NCT00705406|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
1046053|NCT00705406|O1|Outcome|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
1046054|NCT00705406|E2|Reported Event|Peramivir 600 mg|Peramivir 600 mg administered as bilateral 2-mL intramuscular injection.
1046055|NCT00705406|E1|Reported Event|Placebo|Placebo (buffered diluent) administered as bilateral 2-mL intramuscular injection.
1046056|NCT00705367|B3|Baseline|Total|Total of all reporting groups
1046057|NCT00705367|B2|Baseline|Placebo|Infusion, Intravenous, single dose, 24 hours
1046058|NCT00705367|B1|Baseline|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
1046059|NCT00705367|P2|Participant Flow|Placebo/Abatacept,10 mg/kg|Short-term period: Participants received a single dose of placebo intravenously Long-term period: Placebo arm discontinued. All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
1046060|NCT00705367|P1|Participant Flow|Abatacept, 30/10 mg/kg|Short-term period: Participants received a single dose of 30-mg/kg dose of abatacept intravenously (IV) Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
1046061|NCT00705367|O1|Outcome|Abatacept (10 mg/kg)|Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
1046062|NCT00705367|O1|Outcome|Abatacept, 30/10 mg/kg|Short-term period: Participants received a single dose of 30-mg/kg dose of abatacept intravenously (IV) Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
1046063|NCT00705367|O1|Outcome|Abatacept, 30/10 mg/kg|Short-term period: Participants received a single dose of 30-mg/kg dose of abatacept intravenously (IV) Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
1046064|NCT00705367|O1|Outcome|Abatacept, 30/10 mg/kg|Short-term period: Participants received a single dose of 30-mg/kg dose of abatacept intravenously (IV) Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
1046065|NCT00705367|O2|Outcome|Placebo|Infusion, Intravenous, single dose, 24 hours
1046066|NCT00705367|O1|Outcome|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
1046067|NCT00705367|O2|Outcome|Placebo|Infusion, Intravenous, single dose, 24 hours
1046068|NCT00705367|O1|Outcome|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
1046069|NCT00705367|O1|Outcome|Abatacept (10 mg/kg)|Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
1046070|NCT00705367|O2|Outcome|Placebo|Infusion, Intravenous, single dose, 24 hours
1046071|NCT00705367|O1|Outcome|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
1046072|NCT00705367|O2|Outcome|Placebo|Infusion, Intravenous, single dose, 24 hours
1046073|NCT00705367|O1|Outcome|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
1046074|NCT00705367|O2|Outcome|Placebo|Infusion, Intravenous, single dose, 24 hours
1046075|NCT00705367|O1|Outcome|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
1046076|NCT00705367|O2|Outcome|Placebo|Infusion, Intravenous, single dose, 24 hours
1046077|NCT00705367|O1|Outcome|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
1046078|NCT00705367|O1|Outcome|Abatacept (10 mg/kg)|Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
1046079|NCT00705367|O1|Outcome|Abatacept (10 mg/kg)|Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study
1046080|NCT00705367|O2|Outcome|Placebo|Infusion, Intravenous, single dose, 24 hours
1046081|NCT00705367|O1|Outcome|Abatacept (30 mg/kg)|Infusion, Intravenous, 30 mg/kg, single dose, 24 hours
1046082|NCT00705367|E2|Reported Event|Placebo|
1046083|NCT00705367|E1|Reported Event|Abatacept 30 mg/kg|
1046084|NCT00705341|B3|Baseline|Total|Total of all reporting groups
1046085|NCT00705341|B2|Baseline|Asthmatic Controls for Phase 1|People with asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
1046086|NCT00705341|B1|Baseline|Nonasthmatic Controls for Phase 1|People without asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
1046087|NCT00705341|P4|Participant Flow|High Dose, Then Low Dose Fluticasone for Phase 2|People with asthma receive fluticasone at 1000 mcg per day 28 days), then wash-out period (28 days), fluticasone at 250 mcg per day (28 days) in phase 2.
1046088|NCT00705341|P3|Participant Flow|Low Dose, Then High Dose Fluticasone for Phase 2|People with asthma receive fluticasone at 250 mcg per day (28 days), then wash-out period (28 days), then fluticasone at 1000 mcg per day (28 days) in phase 2.
1046089|NCT00705341|P2|Participant Flow|Non Asthmatic Controls for Phase 1|People without asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
1046189|NCT00705081|O2|Outcome|Previously Treated With Statin|subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
1046090|NCT00705341|P1|Participant Flow|Asthmatic Controls for Phase 1|People with asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
1046091|NCT00705341|O2|Outcome|Non Asthmatic Controls for Phase 1|People without asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
1046092|NCT00705341|O1|Outcome|Asthmatic Controls for Phase 1|People with asthma perform 1 methacholine challenge test in phase 1 to measure the sensitivity and specificity of methacholine challenge testing. Participants did not receive an intervention in phase 1.
1046093|NCT00705341|O2|Outcome|4 Weeks of Low Dose Fluticasone|4 weeks of Fluticasone (Flovent diskus) 250 mcg once daily
1046094|NCT00705341|O1|Outcome|4 Weeks of High Dose Fluticasone|4 weeks of Fluticasone (Flovent diskus) 500 mcg twice daily (1000mcg/day)
1046095|NCT00705341|E2|Reported Event|High Dose for Phase 2|4 weeks of Fluticasone (Flovent diskus) 500 mcg twice daily (1000mcg/day)
1046096|NCT00705341|E1|Reported Event|Low Dose for phase1|4 weeks of Fluticasone (Flovent diskus) 250 mcg twice daily (500 mcg/day)
1046097|NCT00705289|B1|Baseline|RA Subjects/ Infliximab 3 mg/kg|Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
1046098|NCT00705289|P1|Participant Flow|RA Subjects/ Infliximab 3 mg/kg|Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
1046099|NCT00705289|O4|Outcome|Established RA, Failed/Did Not Tolerate Another Anti-TNF|Subjects with established RA having failed or not tolerated another anti-TNF.
1046100|NCT00705289|O3|Outcome|Established RA, Not Treated With Anti-TNF|Subjects with established RA not yet treated with an anti-TNF.
1046101|NCT00705289|O2|Outcome|Early RA, Not Treated With Anti-TNF|Subjects with early RA not yet treated with an anti-TNF.
1046102|NCT00705289|O1|Outcome|RA Subjects/ Infliximab 3 mg/kg|Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
1046103|NCT00705289|O12|Outcome|Sweden|
1046104|NCT00705289|O11|Outcome|Portugal|
1046105|NCT00705289|O10|Outcome|Poland|
1046106|NCT00705289|O9|Outcome|Norway|
1046107|NCT00705289|O8|Outcome|Netherlands|
1046108|NCT00705289|O7|Outcome|Italy|
1046109|NCT00705289|O6|Outcome|Greece|
1046110|NCT00705289|O5|Outcome|Germany|
1046111|NCT00705289|O4|Outcome|France|
1046112|NCT00705289|O3|Outcome|Denmark|
1046113|NCT00705289|O2|Outcome|Belgium|
1046114|NCT00705289|O1|Outcome|Austria|
1046115|NCT00705289|O3|Outcome|Female|
1046116|NCT00705289|O2|Outcome|Male|
1046117|NCT00705289|O1|Outcome|RA Subjects/ Infliximab 3 mg/kg|Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
1046118|NCT00705289|O1|Outcome|RA Subjects/ Infliximab 3 mg/kg|Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
1046119|NCT00705289|O1|Outcome|RA Subjects/ Infliximab 3 mg/kg|Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
1046120|NCT00705289|E1|Reported Event|Infliximab 3 mg/kg|
1046121|NCT00705263|B1|Baseline|Patients With Chronic Hepatitis C|Patients with chronic hepatitis C who are treated with the PegIntron pen plus Rebetol will answer questions on the patient questionnaire.
1046122|NCT00705263|P1|Participant Flow|Patients With Chronic Hepatitis C|Patients with chronic hepatitis C who are treated with the PegIntron pen plus Rebetol will answer questions on the patient questionnaire.
1046123|NCT00705263|O1|Outcome|Patients Treated With PegIntron Pen Plus Rebetol|
1046124|NCT00705263|E1|Reported Event|Patients With Chronic Hepatitis C|Patients with chronic hepatitis C who are treated with the PegIntron pen plus Rebetol will answer questions on the patient questionnaire.
1046125|NCT00705250|B1|Baseline|All Participants|
1046126|NCT00705250|P1|Participant Flow|All Participants|Patients will receive bendamustine 120mg/m2, administered as a 30-minute infusion.
1046127|NCT00705250|O1|Outcome|All Participants|
1046128|NCT00705250|E1|Reported Event|All Participants|
1046129|NCT00705224|B1|Baseline|Pegylated Interferon and Ribavirin|"Naïve patients with CHC of any genotype treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous~injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the~morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C."
1046130|NCT00705224|P1|Participant Flow|Pegylated Interferon and Ribavirin|"Naïve patients with chronic hepatitis C (CHC) of any genotype treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous~injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the~morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on hepatitis C virus (HCV) genotype, viral load, activity and stage of hepatitis C."
1046315|NCT00704730|O1|Outcome|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
1046131|NCT00705224|O2|Outcome|HOMA-IR >3|Subgroup of naïve patients with CHC of any genotype and a presence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
1046132|NCT00705224|O1|Outcome|HOMA-IR<=3|Subgroup of naïve patients with CHC of any genotype and an absence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
1046133|NCT00705224|O2|Outcome|HOMA-IR >3|Subgroup of naïve patients with CHC of any genotype and a presence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
1046134|NCT00705224|O1|Outcome|HOMA-IR<=3|Subgroup of naïve patients with CHC of any genotype and an absence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and a stage of hepatitis C.
1046135|NCT00705224|O2|Outcome|HOMA-IR >3|Subgroup of naïve patients with CHC of any genotype and a presence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
1046136|NCT00705224|O1|Outcome|HOMA-IR<=3|Subgroup of naïve patients with CHC of any genotype and an absence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
1046137|NCT00705224|O2|Outcome|HOMA-IR >3|Subgroup of naïve patients with CHC of any genotype and a presence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
1046138|NCT00705224|O1|Outcome|HOMA-IR<=3|Subgroup of naïve patients with CHC of any genotype and an absence of insulin resistance at baseline treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
1046139|NCT00705224|O1|Outcome|Pegylated Interferon and Ribavirin|Naïve patients with CHC of any genotype treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.
1046186|NCT00705081|P1|Participant Flow|Not Previously Treated|subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy
1046187|NCT00705081|O2|Outcome|Previously Treated With Statin|subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
1046188|NCT00705081|O1|Outcome|Not Previously Treated|subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy
1046140|NCT00705224|E1|Reported Event|Pegylated Interferon and Ribavirin|"Naïve patients with chronic hepatitis C (CHC) of any genotype treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous~injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the~morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C."
1046141|NCT00705159|B5|Baseline|Total|Total of all reporting groups
1046142|NCT00705159|B4|Baseline|Vehicle|Vehicle of Zylet. One or two drops in study eye four times a day (QID).
1046143|NCT00705159|B3|Baseline|Tobramycin|Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).
1046144|NCT00705159|B2|Baseline|Loteprednol Etabonate|Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).
1046145|NCT00705159|B1|Baseline|Loteprednol Etabonate and Tobramycin|Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).
1046146|NCT00705159|P4|Participant Flow|Vehicle|Vehicle of Zylet. One or two drops in study eye four times a day (QID).
1046147|NCT00705159|P3|Participant Flow|Tobramycin|Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).
1046148|NCT00705159|P2|Participant Flow|Loteprednol Etabonate|Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).
1046149|NCT00705159|P1|Participant Flow|Loteprednol Etabonate and Tobramycin|Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).
1046150|NCT00705159|O4|Outcome|Vehicle|Vehicle of Zylet. One or two drops in study eye four times a day (QID).
1046151|NCT00705159|O3|Outcome|Tobramycin|Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).
1046152|NCT00705159|O2|Outcome|Loteprednol Etabonate|Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).
1046153|NCT00705159|O1|Outcome|Loteprednol Etabonate and Tobramycin|Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).
1046154|NCT00705159|O4|Outcome|Vehicle|Vehicle of Zylet. One or two drops in study eye four times a day (QID).
1046155|NCT00705159|O3|Outcome|Tobramycin|Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).
1046156|NCT00705159|O2|Outcome|Loteprednol Etabonate|Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).
1046157|NCT00705159|O1|Outcome|Loteprednol Etabonate and Tobramycin|Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).
1046158|NCT00705159|O4|Outcome|Vehicle|Vehicle of Zylet. One or two drops in study eye four times a day (QID).
1046159|NCT00705159|O3|Outcome|Tobramycin|Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).
1046160|NCT00705159|O2|Outcome|Loteprednol Etabonate|Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).
1046161|NCT00705159|O1|Outcome|Loteprednol Etabonate and Tobramycin|Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).
1046162|NCT00705159|E4|Reported Event|Vehicle|Vehicle of Zylet. One or two drops in study eye four times a day (QID).
1046163|NCT00705159|E3|Reported Event|Tobramycin|Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).
1046164|NCT00705159|E2|Reported Event|Loteprednol Etabonate|Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).
1046165|NCT00705159|E1|Reported Event|Loteprednol Etabonate and Tobramycin|Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).
1046166|NCT00705146|B3|Baseline|Total|Total of all reporting groups
1046167|NCT00705146|B2|Baseline|Comfort Cool Then Hybrid Splint|Comfort Cool splint for 4 weeks, 1 wk washout, then Hybrid splint for 4 weeks
1046168|NCT00705146|B1|Baseline|Hybrid Then Comfort Cool|Hybrid splint for 4 weeks, 1 wk washout, then Comfort Cool splint for 4 weeks
1046169|NCT00705146|P2|Participant Flow|Comfort Cool Splint 4 Weeks, 1 Week Washout, Then Hybrid Splin|Comfort Cool splint for 4 weeks, 1 wk washout, then Hybrid splint for 4 weeks
1046170|NCT00705146|P1|Participant Flow|Hybrid Splint 4 Weeks, 1 Week Washout, Then Comfort Cool Splin|Hybrid splint for 4 weeks, 1 wk washout, then Comfort Cool splint for 4 weeks
1046171|NCT00705146|O2|Outcome|Comfort Cool Splint|Use of the comfort cool splint for 4 weeks
1046172|NCT00705146|O1|Outcome|Hybrid Splint|Use of the hybrid splint for 4 weeks
1046173|NCT00705146|O2|Outcome|Comfort Cool Splint|Use of the comfort cool splint for 4 weeks
1046174|NCT00705146|O1|Outcome|Hybrid Splint|Use of the hybrid splint for 4 weeks
1046175|NCT00705146|E2|Reported Event|Comfort Cool Then Hybrid Splint|Comfort Cool splint for 4 weeks, 1 wk washout, then Hybrid splint for 4 weeks
1046176|NCT00705146|E1|Reported Event|Hybrid Then Comfort Cool|Hybrid splint for 4 weeks, 1 wk washout, then Comfort Cool splint for 4 weeks
1046177|NCT00705107|B1|Baseline|All Treated Patients|
1046178|NCT00705107|P1|Participant Flow|All Treated Patients|
1046179|NCT00705107|O1|Outcome|All Treated Patients|
1046180|NCT00705107|O1|Outcome|All Treated Patients|
1046181|NCT00705107|E1|Reported Event|All Treated Patients|
1046182|NCT00705081|B3|Baseline|Total|Total of all reporting groups
1046183|NCT00705081|B2|Baseline|Previously Treated With Statin|subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
1046184|NCT00705081|B1|Baseline|Not Previously Treated|subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy
1046185|NCT00705081|P2|Participant Flow|Previously Treated With Statin|subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
1046316|NCT00704730|O2|Outcome|Placebo|Oral capsules once daily
1054439|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
1046190|NCT00705081|O1|Outcome|Not Previously Treated|subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy
1046191|NCT00705081|O2|Outcome|Previously Treated With Statin|subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
1046192|NCT00705081|O1|Outcome|Not Previously Treated|subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy
1046193|NCT00705081|E2|Reported Event|Previously Treated With Statin|subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy
1046194|NCT00705081|E1|Reported Event|Not Previously Treated|subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy
1046195|NCT00705016|B4|Baseline|Total|Total of all reporting groups
1046196|NCT00705016|B3|Baseline|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
1046197|NCT00705016|B2|Baseline|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
1046198|NCT00705016|B1|Baseline|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
1046199|NCT00705016|P3|Participant Flow|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
1046200|NCT00705016|P2|Participant Flow|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
1046201|NCT00705016|P1|Participant Flow|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
1046202|NCT00705016|O3|Outcome|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
1046203|NCT00705016|O2|Outcome|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
1046265|NCT00704938|E2|Reported Event|Anti-p53 TCR PBL + DC + IL-2: Other Histology|Patients with other histologies will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
1046266|NCT00704938|E1|Reported Event|Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC|Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
1046204|NCT00705016|O1|Outcome|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
1046205|NCT00705016|O3|Outcome|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
1046206|NCT00705016|O2|Outcome|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
1046207|NCT00705016|O1|Outcome|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
1046208|NCT00705016|O3|Outcome|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
1046209|NCT00705016|O2|Outcome|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
1046210|NCT00705016|O1|Outcome|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
1046211|NCT00705016|O3|Outcome|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
1046212|NCT00705016|O2|Outcome|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
1046213|NCT00705016|O1|Outcome|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
1046267|NCT00704912|B4|Baseline|Total|Total of all reporting groups
1046214|NCT00705016|O3|Outcome|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
1046215|NCT00705016|O2|Outcome|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
1046216|NCT00705016|O1|Outcome|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
1046217|NCT00705016|O3|Outcome|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
1046218|NCT00705016|O2|Outcome|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
1046219|NCT00705016|O1|Outcome|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
1046220|NCT00705016|O3|Outcome|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
1046221|NCT00705016|O2|Outcome|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
1046222|NCT00705016|O1|Outcome|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
1046223|NCT00705016|E3|Reported Event|Cetuximab+5-FU+Cisplatin|Cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly along with 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
1046268|NCT00704912|B3|Baseline|Lifestyle/OCP Combined|Combination of treatments: Medications will be administered as described for the other 2 arms.
1046317|NCT00704730|O1|Outcome|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
1046224|NCT00705016|E2|Reported Event|Cilengitide 2000 mg Twice Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 2000 mg intravenous infusion over 60 minutes twice weekly along with cetuximab 250 mg/m^2 intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
1046225|NCT00705016|E1|Reported Event|Cilengitide 2000 mg Once Weekly+Cetuximab+5-FU+Cisplatin|Cilengitide 500 milligram (mg) intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by cilengitide 2000 mg once weekly along with cetuximab 250 milligram per square meter (mg/m^2) intravenous infusion (initial starting dose of 400 mg/m^2) once weekly, 5-fluorouracil (5-FU) 1000 mg/m^2 intravenous continuous infusion daily from Day 1 to 4 and cisplatin 100 mg/m^2 intravenous infusion over 60 minutes on Day 1, of each 3-week treatment cycle for a total of 6 cycles (18 weeks) or until progressive disease (PD), unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly along with cetuximab 250 mg/m^2 intravenous infusion until PD, unacceptable toxicity or withdrawal for any other reason.
1046226|NCT00705003|B4|Baseline|Total|Total of all reporting groups
1046227|NCT00705003|B3|Baseline|Placebo|Placebo QD
1046228|NCT00705003|B2|Baseline|BCI-024|Buspirone 15 mg QD
1046229|NCT00705003|B1|Baseline|BCI-024 and BCI-049|Buspirone 15 mg and Melatonin 3 mg QD
1046230|NCT00705003|P3|Participant Flow|Placebo|Matching placebo QD
1046231|NCT00705003|P2|Participant Flow|BCI-024 (Buspirone)|1 over-encapsulated tablet of buspirone 15 mg QD
1046232|NCT00705003|P1|Participant Flow|BCI-024 and BCI-049 (Buspirone and Melatonin)|1 over-encapsulated tablet of buspirone 15 mg and 1 over-encapsulated tablet of melatonin 3 mg QD
1046233|NCT00705003|O3|Outcome|Placebo|Placebo QD
1046234|NCT00705003|O2|Outcome|BCI-024|Buspirone 15 mg QD
1046235|NCT00705003|O1|Outcome|BCI-024 and BCI-049|Buspirone 15 mg and Melatonin 3 mg QD
1046236|NCT00705003|O3|Outcome|Placebo|Placebo QD
1046237|NCT00705003|O2|Outcome|BCI-024|Buspirone 15 mg QD
1046238|NCT00705003|O1|Outcome|BCI-024 and BCI-049|Buspirone 15 mg and Melatonin 3 mg QD
1046239|NCT00705003|O3|Outcome|Placebo|Placebo QD
1046240|NCT00705003|O2|Outcome|BCI-024|Buspirone 15 mg QD
1046241|NCT00705003|O1|Outcome|BCI-024 and BCI-049|Buspirone 15 mg and Melatonin 3 mg QD
1046242|NCT00705003|O3|Outcome|Placebo|Placebo QD
1046243|NCT00705003|O2|Outcome|BCI-024|Buspirone 15 mg QD
1046244|NCT00705003|O1|Outcome|BCI-024 and BCI-049|Buspirone 15 mg and Melatonin 3 mg QD
1046245|NCT00705003|O3|Outcome|Placebo|Placebo QD
1046246|NCT00705003|O2|Outcome|BCI-024|Buspirone 15 mg QD
1046247|NCT00705003|O1|Outcome|BCI-024+BCI-049|Buspirone 15 mg and Melatonin 3 mg QD
1046248|NCT00705003|E3|Reported Event|Placebo|Placebo QD
1046249|NCT00705003|E2|Reported Event|BCI-024|Buspirone 15 mg QD
1046250|NCT00705003|E1|Reported Event|BCI-024 and BCI-049|Buspirone 15 mg and Melatonin 3 mg QD
1046251|NCT00704964|B1|Baseline|All Participants|Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites.
1046252|NCT00704964|P1|Participant Flow|All Participants|"Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites.~Completers are considered those with documentation who finished the study on time."
1046253|NCT00704964|O1|Outcome|All Participants|Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites.
1046254|NCT00704964|O1|Outcome|All Participants|Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites.
1046255|NCT00704964|E1|Reported Event|All Participants|
1046256|NCT00704938|B3|Baseline|Total|Total of all reporting groups
1046257|NCT00704938|B2|Baseline|Anti-p53 TCR PBL + DC + IL-2: Other Histology|Patients with other histologies will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
1046258|NCT00704938|B1|Baseline|Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC|Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
1046259|NCT00704938|P2|Participant Flow|Anti-p53 TCR PBL + DC + IL-2: Other Histology|Patients with other histologies will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
1046260|NCT00704938|P1|Participant Flow|Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC|Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
1046261|NCT00704938|O2|Outcome|Anti-p53 TCR PBL + DC + IL-2: Other Histology|Patients with other histologies will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
1046262|NCT00704938|O1|Outcome|Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC|Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
1046263|NCT00704938|O2|Outcome|Anti-p53 TCR PBL + DC + IL-2: Other Histology|Patients with other histologies will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
1046264|NCT00704938|O1|Outcome|Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC|Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)
1046269|NCT00704912|B2|Baseline|Oral Contraceptives (OCP)|Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
1046270|NCT00704912|B1|Baseline|Lifestyle Intervention|Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
1046271|NCT00704912|P3|Participant Flow|Lifestyle/OCP Combined|Combination of treatments: Medications will be administered as described for the other 2 arms.
1046272|NCT00704912|P2|Participant Flow|Oral Contraceptives (OCP)|Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
1046273|NCT00704912|P1|Participant Flow|Lifestyle Intervention|Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
1046274|NCT00704912|O3|Outcome|Lifestyle/OCP Combined|Combination of treatments: Medications will be administered as described for the other 2 arms.
1046275|NCT00704912|O2|Outcome|Oral Contraceptives (OCP)|Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
1046276|NCT00704912|O1|Outcome|Lifestyle Intervention|Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
1046277|NCT00704912|O3|Outcome|Lifestyle/OCP Combined|Combination of treatments: Medications will be administered as described for the other 2 arms.
1046278|NCT00704912|O2|Outcome|Oral Contraceptives (OCP)|Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
1046279|NCT00704912|O1|Outcome|Lifestyle Intervention|Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
1046280|NCT00704912|O3|Outcome|Lifestyle/OCP Combined|Combination of treatments: Medications will be administered as described for the other 2 arms.
1046281|NCT00704912|O2|Outcome|Oral Contraceptives (OCP)|Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
1046282|NCT00704912|O1|Outcome|Lifestyle Intervention|Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
1046283|NCT00704912|O3|Outcome|Lifestyle/OCP Combined|Combination of treatments: Medications will be administered as described for the other 2 arms.
1046284|NCT00704912|O2|Outcome|Oral Contraceptives (OCP)|Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
1046285|NCT00704912|O1|Outcome|Lifestyle Intervention|Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
1046286|NCT00704912|E3|Reported Event|Lifestyle/OCP Combined|Combination of treatments: Medications will be administered as described for the other 2 arms.
1046287|NCT00704912|E2|Reported Event|Oral Contraceptives (OCP)|Loestrin 1/20: Patients will be started on a low dose containing OCP (20 mcg ethinyl estradiol/1 mg norethindrone acetate daily) for a continuous 4 month period.
1046288|NCT00704912|E1|Reported Event|Lifestyle Intervention|Orlistat/Meal Replacement/Lifestyle Modification: Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.
1046289|NCT00704847|B3|Baseline|Total|Total of all reporting groups
1046290|NCT00704847|B2|Baseline|SMC021 Placebo|1 SMC021 Placebo tablet twice daily
1046291|NCT00704847|B1|Baseline|SMC021 Oral Calcitonin|0.8 mg SMC021 Oral Calcitonin twice daily
1046292|NCT00704847|P2|Participant Flow|SMC021 Placebo|1 SMC021 Placebo tablet twice daily
1046293|NCT00704847|P1|Participant Flow|SMC021 Oral Calcitonin|0.8 mg SMC021 Oral Calcitonin twice daily
1046294|NCT00704847|O2|Outcome|SMC021 Placebo|1 SMC021 Placebo tablet twice daily
1046295|NCT00704847|O1|Outcome|SMC021 Oral Calcitonin|0.8 mg SMC021 Oral Calcitonin twice daily
1046296|NCT00704847|O2|Outcome|SMC021 Placebo|1 SMC021 Placebo tablet twice daily
1046297|NCT00704847|O1|Outcome|SMC021 Oral Calcitonin|0.8 mg SMC021 Oral Calcitonin twice daily
1046298|NCT00704847|E2|Reported Event|SMC021 Placebo|1 SMC021 Placebo tablet twice daily
1046299|NCT00704847|E1|Reported Event|SMC021 Oral Calcitonin|0.8 mg SMC021 Oral Calcitonin twice daily
1046300|NCT00704808|B1|Baseline|Temozolomide|Surgery followed by temozolomide concomitant with radiotherapy (dosed according to the Summary of Product Characteristics [SPC]), then adjuvant monochemotherapy temozolomide (dosed according to the SPC)
1046301|NCT00704808|P1|Participant Flow|Temozolomide|Surgery followed by temozolomide concomitant with radiotherapy (dosed according to the Summary of Product Characteristics [SPC]), then adjuvant monochemotherapy temozolomide (dosed according to the SPC)
1046302|NCT00704808|O1|Outcome|Temozolomide|Surgery followed by temozolomide concomitant with radiotherapy (dosed according to the Summary of Product Characteristics [SPC]), then adjuvant monochemotherapy temozolomide (dosed according to the SPC)
1046303|NCT00704808|E1|Reported Event|Temozolomide|
1046304|NCT00704769|B1|Baseline|Desloratadine|
1046305|NCT00704769|P1|Participant Flow|Desloratadine|
1046306|NCT00704769|O1|Outcome|Desloratadine|
1046307|NCT00704769|O1|Outcome|Desloratadine|
1046308|NCT00704769|E1|Reported Event|Desloratadine|
1046309|NCT00704730|B3|Baseline|Total|Total of all reporting groups
1046310|NCT00704730|B2|Baseline|Placebo|oral capsules once daily
1046311|NCT00704730|B1|Baseline|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
1046312|NCT00704730|P2|Participant Flow|Placebo|oral capsules once daily
1046313|NCT00704730|P1|Participant Flow|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
1046314|NCT00704730|O2|Outcome|Placebo|Oral capsules once daily
1046318|NCT00704730|O2|Outcome|Placebo|Oral capsules once daily
1046319|NCT00704730|O1|Outcome|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
1046320|NCT00704730|O2|Outcome|Placebo|Oral capsules once daily
1046321|NCT00704730|O1|Outcome|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
1046322|NCT00704730|O2|Outcome|Placebo|Oral capsules once daily
1046323|NCT00704730|O1|Outcome|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
1046324|NCT00704730|O2|Outcome|Placebo|Oral capsules once daily
1046325|NCT00704730|O1|Outcome|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily.
1046326|NCT00704730|E2|Reported Event|Placebo|oral capsules once daily
1046327|NCT00704730|E1|Reported Event|XL184 (Cabozantinib)|XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
1046328|NCT00704717|B1|Baseline|All Treated Patients|All patients participating in the study.
1046329|NCT00704717|P1|Participant Flow|All Treated Patients|All patients participating in the study.
1046330|NCT00704717|O1|Outcome|All Treated Patients|All patients participating in the study.
1046331|NCT00704717|E1|Reported Event|All Treated Patients|All patients participating in the study.
1046332|NCT00704535|B1|Baseline|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
1046333|NCT00704535|P1|Participant Flow|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
1046334|NCT00704535|O1|Outcome|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
1046335|NCT00704535|O1|Outcome|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
1046336|NCT00704535|O1|Outcome|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
1046337|NCT00704535|O1|Outcome|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
1046338|NCT00704535|O1|Outcome|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
1046339|NCT00704535|O1|Outcome|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
1046340|NCT00704535|O1|Outcome|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
1046341|NCT00704535|O1|Outcome|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
1046342|NCT00704535|E1|Reported Event|Ezetimibe as Prescribed by the Physician in Normal Practice|Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin
1046343|NCT00704522|B3|Baseline|Total|Total of all reporting groups
1046344|NCT00704522|B2|Baseline|PegIntron Pen/Rebetol With Patient Assistance Program|"PegIntron & Rebetol will be administered according to the products' labeling. Assistance programs include medications used prophylactically or for treatment (Growth factors: RBC and neutrophil; Psychiatric medications; Other~medications) - Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature)."
1046345|NCT00704522|B1|Baseline|PegIntron Pen/Rebetol Without Patient Assistance Program|PegIntron & Rebetol will be administered according to the products' labeling.
1046346|NCT00704522|P2|Participant Flow|PegIntron Pen/Rebetol With Patient Assistance Program|"PegIntron & Rebetol will be administered according to the products' labeling. Assistance programs include medications used prophylactically or for treatment (Growth factors: RBC and neutrophil; Psychiatric medications; Other~medications) - Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature)."
1046347|NCT00704522|P1|Participant Flow|PegIntron Pen/Rebetol Without Patient Assistance Program|PegIntron & Rebetol will be administered according to the products' labeling.
1046348|NCT00704522|O2|Outcome|PegIntron Pen/Rebetol With Patient Assistance Program|"PegIntron & Rebetol will be administered according to the products' labeling. Assistance programs include medications used prophylactically or for treatment (Growth factors: RBC and neutrophil; Psychiatric medications; Other~medications) - Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature)."
1046349|NCT00704522|O1|Outcome|PegIntron Pen/Rebetol Without Patient Assistance Program|PegIntron & Rebetol will be administered according to the products' labeling.
1046350|NCT00704522|O2|Outcome|PegIntron Pen/Rebetol With Patient Assistance Program|"PegIntron & Rebetol will be administered according to the products' labeling. Assistance programs include medications used prophylactically or for treatment (Growth factors: RBC and neutrophil; Psychiatric medications; Other~medications) - Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature)."
1046351|NCT00704522|O1|Outcome|PegIntron Pen/Rebetol Without Patient Assistance Program|PegIntron & Rebetol will be administered according to the products' labeling.
1046352|NCT00704522|E1|Reported Event|PegIntron Pen/Rebetol|
1046353|NCT00704418|B3|Baseline|Total|Total of all reporting groups
1046354|NCT00704418|B2|Baseline|Placebo|Placebo, dosed 1 drop daily
1046355|NCT00704418|B1|Baseline|Bromfenac|Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily
1046356|NCT00704418|P2|Participant Flow|Placebo|Placebo, dosed 1 drop daily
1046357|NCT00704418|P1|Participant Flow|Bromfenac|Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily
1046358|NCT00704418|O2|Outcome|Placebo|Placebo, dosed 1 drop daily
1046365|NCT00704405|B5|Baseline|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
1046366|NCT00704405|B4|Baseline|48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.
1046367|NCT00704405|B3|Baseline|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.
1046368|NCT00704405|B2|Baseline|24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
1046369|NCT00704405|B1|Baseline|24-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and peg-IFN 180 mcg injection once weekly for 24 weeks.
1046370|NCT00704405|P5|Participant Flow|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
1046371|NCT00704405|P4|Participant Flow|48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.
1046372|NCT00704405|P3|Participant Flow|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.
1046373|NCT00704405|P2|Participant Flow|24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
1046374|NCT00704405|P1|Participant Flow|24-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and peg-IFN 180 mcg injection once weekly for 24 weeks.
1046375|NCT00704405|O2|Outcome|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
1046376|NCT00704405|O1|Outcome|24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.
1046377|NCT00704405|O3|Outcome|PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
1046378|NCT00704405|O2|Outcome|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
1046379|NCT00704405|O1|Outcome|24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.
1046380|NCT00704405|O2|Outcome|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
1046381|NCT00704405|O1|Outcome|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
1046382|NCT00704405|O5|Outcome|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
1046383|NCT00704405|O4|Outcome|48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
1046384|NCT00704405|O3|Outcome|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
1046385|NCT00704405|O2|Outcome|24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
1046386|NCT00704405|O1|Outcome|24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.
1046387|NCT00704405|O5|Outcome|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
1046388|NCT00704405|O4|Outcome|48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
1046389|NCT00704405|O3|Outcome|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
1046390|NCT00704405|O2|Outcome|24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
1046391|NCT00704405|O1|Outcome|24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.
1046392|NCT00704405|O4|Outcome|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
1046393|NCT00704405|O3|Outcome|48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.
1046433|NCT00704340|P1|Participant Flow|DuraSeal|DuraSeal Dural Sealant System - FDA Approved Device
1046434|NCT00704340|O2|Outcome|Control|Standard of Care (control)
1046394|NCT00704405|O2|Outcome|24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
1046395|NCT00704405|O1|Outcome|24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.
1046396|NCT00704405|E5|Reported Event|48-wk PBO + Peg-IFN/RBV|PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.
1046397|NCT00704405|E4|Reported Event|48-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.
1046398|NCT00704405|E3|Reported Event|48-wk Vaniprevir 300 mg + Peg-IFN/RBV|Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.
1046399|NCT00704405|E2|Reported Event|24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for an additional 24 weeks.
1046400|NCT00704405|E1|Reported Event|24-wk Vaniprevir 600 mg + Peg-IFN/RBV|Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and peg-IFN 180 mcg injection once weekly for 24 weeks.
1046401|NCT00704379|B3|Baseline|Total|Total of all reporting groups
1046402|NCT00704379|B2|Baseline|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
1046403|NCT00704379|B1|Baseline|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
1046404|NCT00704379|P2|Participant Flow|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
1046405|NCT00704379|P1|Participant Flow|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
1046406|NCT00704379|O2|Outcome|Patients Who Did Not Developped a Mood or Anxiety Disorder|
1046407|NCT00704379|O1|Outcome|Patients Who Developped a Mood or Anxiety Disorder|
1046408|NCT00704379|O2|Outcome|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
1046409|NCT00704379|O1|Outcome|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
1046410|NCT00704379|O2|Outcome|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
1046411|NCT00704379|O1|Outcome|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
1046412|NCT00704379|O2|Outcome|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
1046413|NCT00704379|O1|Outcome|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
1046414|NCT00704379|O2|Outcome|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
1046415|NCT00704379|O1|Outcome|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
1046416|NCT00704379|O2|Outcome|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
1046417|NCT00704379|O1|Outcome|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
1046418|NCT00704379|E2|Reported Event|Sertraline|Sertraline (other name: Zoloft) was administered in a double blind fashion via tablets administered once daily. Targeted dosage: 100 mg/day.
1046419|NCT00704379|E1|Reported Event|Placebo|Placebo (i.e., an inactive substance) was given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
1046420|NCT00704353|B3|Baseline|Total|Total of all reporting groups
1046421|NCT00704353|B2|Baseline|Standard Medical Care|Subjects received standard medical care (as determined by the Investigator) for treatment of IDA.
1046422|NCT00704353|B1|Baseline|Ferric Carboxymaltose (FCM)|Subjects receieved an undiluted dose of iron as FCM (15mg/kg up to a maximum of 750 mg) at 100 mg/minute on Day 0.
1046423|NCT00704353|P2|Participant Flow|Standard Medical Care|Subjects received standard medical care (as determined by the Investigator) for treatment of IDA.
1046424|NCT00704353|P1|Participant Flow|Ferric Carboxymaltose (FCM)|Subjects receieved an undiluted dose of iron as FCM (15mg/kg up to a maximum of 750 mg) at 100 mg/minute on Day 0.
1046425|NCT00704353|O2|Outcome|Standard Medical Care|Received standard medical care (as determined by the Investigator) of IDA.
1046426|NCT00704353|O1|Outcome|Ferric Carboxymaltose (FCM)|Subjects received an undiluted dose of iron as FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg/minute on Day 0.
1046427|NCT00704353|E2|Reported Event|Standard Medical Care|Received standard medical care (as determined by the Investigator) of IDA.
1046428|NCT00704353|E1|Reported Event|Ferric Carboxymaltose (FCM)|Subjects received an undiluted dose of iron as FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg/minute on Day 0.
1046429|NCT00704340|B3|Baseline|Total|Total of all reporting groups
1046430|NCT00704340|B2|Baseline|Control|Standard of Care (control)
1046431|NCT00704340|B1|Baseline|DuraSeal|DuraSeal Dural Sealant System - FDA Approved Device
1046432|NCT00704340|P2|Participant Flow|Control|Standard of Care (control)
1055931|NCT00679263|O2|Outcome|Placebo|MN-221 Placebo continuous infusion
1046435|NCT00704340|O1|Outcome|DuraSeal|DuraSeal Dural Sealant System - FDA Approved Device
1046436|NCT00704340|O2|Outcome|Control|Standard of Care (control)
1046437|NCT00704340|O1|Outcome|DuraSeal|DuraSeal Dural Sealant System - FDA Approved Device
1046438|NCT00704340|O2|Outcome|Control|Standard of Care (control)
1046439|NCT00704340|O1|Outcome|DuraSeal|DuraSeal Dural Sealant System - FDA Approved Device
1046440|NCT00704340|E2|Reported Event|Control|Standard of Care (control)
1046441|NCT00704340|E1|Reported Event|DuraSeal|DuraSeal Dural Sealant System - FDA Approved Device
1046442|NCT00704184|B6|Baseline|Total|Total of all reporting groups
1046443|NCT00704184|B5|Baseline|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046444|NCT00704184|B4|Baseline|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046445|NCT00704184|B3|Baseline|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046446|NCT00704184|B2|Baseline|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046447|NCT00704184|B1|Baseline|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046448|NCT00704184|P5|Participant Flow|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046449|NCT00704184|P4|Participant Flow|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046450|NCT00704184|P3|Participant Flow|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046451|NCT00704184|P2|Participant Flow|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046452|NCT00704184|P1|Participant Flow|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046453|NCT00704184|O5|Outcome|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046454|NCT00704184|O4|Outcome|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046455|NCT00704184|O3|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046456|NCT00704184|O2|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046457|NCT00704184|O1|Outcome|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046458|NCT00704184|O5|Outcome|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046459|NCT00704184|O4|Outcome|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046460|NCT00704184|O3|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046461|NCT00704184|O2|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046462|NCT00704184|O1|Outcome|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046463|NCT00704184|O5|Outcome|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046464|NCT00704184|O4|Outcome|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046465|NCT00704184|O3|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046466|NCT00704184|O2|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046467|NCT00704184|O1|Outcome|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046468|NCT00704184|O5|Outcome|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046511|NCT00704132|P1|Participant Flow|Sitagliptin|Participants were administered sitagliptin 100 mg tablet once daily before the morning meal for six weeks.
1046512|NCT00704132|O2|Outcome|Placebo|Participants were administered sitagliptin matching placebo tablet once daily before the morning meal for six weeks.
1046469|NCT00704184|O4|Outcome|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046470|NCT00704184|O3|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046471|NCT00704184|O2|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046472|NCT00704184|O1|Outcome|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046473|NCT00704184|O5|Outcome|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046474|NCT00704184|O4|Outcome|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046475|NCT00704184|O3|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046476|NCT00704184|O2|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046477|NCT00704184|O1|Outcome|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046478|NCT00704184|O5|Outcome|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046479|NCT00704184|O4|Outcome|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046480|NCT00704184|O3|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046481|NCT00704184|O2|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046482|NCT00704184|O1|Outcome|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046483|NCT00704184|E5|Reported Event|Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046484|NCT00704184|E4|Reported Event|Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046485|NCT00704184|E3|Reported Event|Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046486|NCT00704184|E2|Reported Event|Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin|Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046487|NCT00704184|E1|Reported Event|Placebo + Peg-IFN/Ribavirin|Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
1046488|NCT00704171|B3|Baseline|Total|Total of all reporting groups
1046489|NCT00704171|B2|Baseline|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
1046490|NCT00704171|B1|Baseline|PleuraSeal|PleuraSeal Lung Sealant System
1046491|NCT00704171|P2|Participant Flow|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
1046492|NCT00704171|P1|Participant Flow|PleuraSeal|PleuraSeal Lung Sealant System
1046493|NCT00704171|O2|Outcome|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
1046494|NCT00704171|O1|Outcome|PleuraSeal|PleuraSeal Lung Sealant System
1046495|NCT00704171|O2|Outcome|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
1046496|NCT00704171|O1|Outcome|PleuraSeal|PleuraSeal Lung Sealant System
1046497|NCT00704171|O2|Outcome|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
1046498|NCT00704171|O1|Outcome|PleuraSeal|PleuraSeal Lung Sealant System
1046499|NCT00704171|O2|Outcome|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
1046500|NCT00704171|O1|Outcome|PleuraSeal|PleuraSeal Lung Sealant System
1046501|NCT00704171|O2|Outcome|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
1046502|NCT00704171|O1|Outcome|PleuraSeal|PleuraSeal Lung Sealant System
1046503|NCT00704171|O2|Outcome|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
1046504|NCT00704171|O1|Outcome|PleuraSeal|PleuraSeal Lung Sealant System
1046505|NCT00704171|E2|Reported Event|Standard of Care|Standard tissue closure techniques (control) - sutures or staples only
1046506|NCT00704171|E1|Reported Event|PleuraSeal|PleuraSeal Lung Sealant System
1046507|NCT00704132|B3|Baseline|Total|Total of all reporting groups
1046508|NCT00704132|B2|Baseline|Placebo|Participants were administered sitagliptin matching placebo tablet once daily before the morning meal for six weeks.
1046509|NCT00704132|B1|Baseline|Sitagliptin|Participants were administered sitagliptin 100 mg tablet once daily before the morning meal for six weeks.
1046510|NCT00704132|P2|Participant Flow|Placebo|Participants were administered sitagliptin matching placebo tablet once daily before the morning meal for six weeks.
1046837|NCT00703118|O3|Outcome|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
1046513|NCT00704132|O1|Outcome|Sitagliptin|Participants were administered sitagliptin 100 mg tablet once daily before the morning meal for six weeks.
1046514|NCT00704132|E2|Reported Event|Placebo|Participants were administered sitagliptin matching placebo tablet once daily before the morning meal for six weeks.
1046515|NCT00704132|E1|Reported Event|Sitagliptin|Participants were administered sitagliptin 100 mg tablet once daily before the morning meal for six weeks.
1046516|NCT00704028|B3|Baseline|Total|Total of all reporting groups
1046517|NCT00704028|B2|Baseline|Iron Dextran|As determined by the investigator to a maximum cumulative dose of 2,250 mg.
1046518|NCT00704028|B1|Baseline|Ferric Carboxymaltose (FCM)|15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
1046519|NCT00704028|P2|Participant Flow|Iron Dextran|As determined by the investigator to a maximum cumulative dose of 2,250 mg.
1046520|NCT00704028|P1|Participant Flow|Ferric Carboxymaltose (FCM)|15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
1046521|NCT00704028|O2|Outcome|Iron Dextran|As determined by the investigator to a maximum cumulative dose of 2,250 mg.
1046522|NCT00704028|O1|Outcome|Ferric Carboxymaltose (FCM)|15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
1046523|NCT00704028|E2|Reported Event|Iron Dextran|As determined by the investigator to a maximum cumulative dose of 2,250 mg.
1046524|NCT00704028|E1|Reported Event|Ferric Carboxymaltose (FCM)|15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
1046525|NCT00703976|B3|Baseline|Total|Total of all reporting groups
1046526|NCT00703976|B2|Baseline|Cetuximab, Pemetrexed, Radiation Therapy Plus Bevacizumab|"Cetuximab, Pemetrexed, Radiation Therapy plus Bevacizumab~Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.~Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.~Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks~Bevacizumab: Bevacizumab is approved by the Food and Drug Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of chemotherapy."
1046527|NCT00703976|B1|Baseline|Cetuximab, Pemetrexed and Radiation Therapy|"Cetuximab, Pemetrexed and Radiation therapy~Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.~Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.~Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks"
1046528|NCT00703976|P2|Participant Flow|Cetuximab, Pemetrexed, Radiation Therapy Plus Bevacizumab|"Cetuximab, Pemetrexed, Radiation Therapy plus Bevacizumab~Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.~Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.~Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks~Bevacizumab: Bevacizumab is approved by the Food and Drug Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of chemotherapy."
1046529|NCT00703976|P1|Participant Flow|Cetuximab, Pemetrexed and Radiation Therapy|"Cetuximab, Pemetrexed and Radiation therapy~Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.~Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.~Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks"
1046530|NCT00703976|O3|Outcome|Cetuximab, Pemetrexed, Radiation Therapy Plus Bevacizumab|"Cetuximab, Pemetrexed, Radiation Therapy plus Bevacizumab~Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.~Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.~Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks~Bevacizumab: Bevacizumab is approved by the Food and Drug Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of chemotherapy."
1046531|NCT00703976|O2|Outcome|Cetuximab, Pemetrexed and Radiation Therapy|"Cetuximab, Pemetrexed and Radiation therapy~Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.~Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.~Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks"
1046532|NCT00703976|O1|Outcome|All Participants (Overall Study)|
1046533|NCT00703976|O2|Outcome|Cetuximab, Pemetrexed, Radiation Therapy Plus Bevacizumab|"Cetuximab, Pemetrexed, Radiation Therapy plus Bevacizumab~Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.~Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.~Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks~Bevacizumab: Bevacizumab is approved by the Food and Drug Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of chemotherapy."
1046559|NCT00703924|B2|Baseline|Placebo|"Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.~Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion"
1046838|NCT00703118|O2|Outcome|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
1046534|NCT00703976|O1|Outcome|Cetuximab, Pemetrexed and Radiation Therapy|"Cetuximab, Pemetrexed and Radiation therapy~Cetuximab: Cetuximab is approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments.~Pemetrexed: Pemetrexed is approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy.~Radiation therapy: Radiation therapy standard fractionation 2 Gy/day without planned interruptions beginning on day 1 (Monday or Tuesday preferred). Radiation will be given 5 days/week, Monday through Friday, for 7 consecutive weeks"
1046535|NCT00703976|E1|Reported Event|All Participants (Overall Study)|
1046536|NCT00703963|B3|Baseline|Total|Total of all reporting groups
1046537|NCT00703963|B2|Baseline|Patient Self Testing|Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
1046538|NCT00703963|B1|Baseline|Usual Care|Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.
1046539|NCT00703963|P2|Participant Flow|Patient Self Testing|Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
1046540|NCT00703963|P1|Participant Flow|Usual Care|Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.
1046541|NCT00703963|O2|Outcome|Patient Self Testing|Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
1046542|NCT00703963|O1|Outcome|Usual Care|Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.
1046543|NCT00703963|O2|Outcome|Patient Self Testing|Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
1046544|NCT00703963|O1|Outcome|Usual Care|Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.
1046545|NCT00703963|O2|Outcome|Patient Self Testing|Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
1046546|NCT00703963|O1|Outcome|Usual Care|Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.
1046547|NCT00703963|E2|Reported Event|Patient Self Testing|Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.
1046548|NCT00703963|E1|Reported Event|Usual Care|Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.
1046549|NCT00703937|B3|Baseline|Total|Total of all reporting groups
1046550|NCT00703937|B2|Baseline|Standard Medical Care (SMC) for the Treatment of IDA|SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
1046551|NCT00703937|B1|Baseline|Ferric Carboxymaltose (FCM)|750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg).
1046552|NCT00703937|P2|Participant Flow|Standard Medical Care (SMC) for the Treatment of IDA|SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
1046553|NCT00703937|P1|Participant Flow|Ferric Carboxymaltose (FCM)|750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg).
1046554|NCT00703937|O2|Outcome|Standard Medical Care (SMC) for the Treatment of IDA|SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
1046555|NCT00703937|O1|Outcome|Ferric Carboxymaltose (FCM)|750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg).
1046556|NCT00703937|E2|Reported Event|Standard Medical Care (SMC) for the Treatment of IDA|SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
1046557|NCT00703937|E1|Reported Event|Ferric Carboxymaltose (FCM)|750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg).
1046558|NCT00703924|B3|Baseline|Total|Total of all reporting groups
1046698|NCT00703508|O1|Outcome|G/G Genotype|Metformin tablet, 500 mg per tablet, 2 tablets every 12 hours
1046560|NCT00703924|B1|Baseline|WR 279,396|"WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin~WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion"
1046561|NCT00703924|P2|Participant Flow|Placebo|"Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.~Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion"
1046562|NCT00703924|P1|Participant Flow|WR 279,396|"WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin~WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion"
1046563|NCT00703924|O2|Outcome|Placebo|"Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.~Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion"
1046564|NCT00703924|O1|Outcome|WR 279,396|"WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin~WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion"
1046565|NCT00703924|O2|Outcome|Placebo|"Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.~Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion"
1046566|NCT00703924|O1|Outcome|WR 279,396|"WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin~WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion"
1046567|NCT00703924|O4|Outcome|Day 180 (+7 Days)|100% Re-epithelialization by day 180 (+7 days)
1046568|NCT00703924|O3|Outcome|Day 100|100% Re-epithelialization by day 100
1046569|NCT00703924|O2|Outcome|Day 50|100% Re-epithelialization by day 50
1046570|NCT00703924|O1|Outcome|Day 20|100% Re-epithelialization by day 20
1046571|NCT00703924|O2|Outcome|Placebo|"Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.~Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion"
1046572|NCT00703924|O1|Outcome|WR 279,396|"WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin~WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion"
1046573|NCT00703924|O2|Outcome|Placebo|"Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.~Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion"
1046574|NCT00703924|O1|Outcome|WR 279,396|"WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin~WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion"
1046575|NCT00703924|E2|Reported Event|Placebo|"Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.~Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion"
1046576|NCT00703924|E1|Reported Event|WR 279,396|"WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin~WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion"
1046577|NCT00703911|B1|Baseline|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
1046578|NCT00703911|P1|Participant Flow|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
1046579|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
1046580|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
1046581|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
1046582|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
1046583|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
1046584|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
1046585|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
1046586|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
1046587|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
1046588|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
1046699|NCT00703508|O3|Outcome|C/C Genotype|Metformin tablet, 500 mg per tablet, 2 tablets every 12 hours
1046589|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
1046590|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
1046591|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
1046592|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
1046593|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
1046594|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
1046595|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
1046596|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
1046597|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
1046598|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
1046599|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
1046600|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
1046601|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
1046602|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
1046603|NCT00703911|O1|Outcome|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
1046604|NCT00703911|E1|Reported Event|Activated Recombinant Human Factor VII|Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds
1046605|NCT00703885|B1|Baseline|ALL SUBJECTS RECEIVE ALL 3 TREATMENTS|"Alprazolam Low Dose Alprazolam High Dose Placebo~Please note that this is a cross-over design with all subjects receiving all three treatments"
1046606|NCT00703885|P1|Participant Flow|ALL SUBJECTS RECEIVE ALL 3 TREATMENTS|"Alprazolam Low Dose Alprazolam High Dose Placebo~Sequence of administration not available for subjects"
1046607|NCT00703885|O1|Outcome|Imaging Data for Repeated Measures|"Crossover design. Each subject receives, in randomized order and on different days:~Low dose alprazolam High dose alprazolam Placebo"
1046608|NCT00703885|O1|Outcome|BOLD fMRI|Cross-over design. Each subject receives, on alternate days and in randomized fashion, either low dose, high dose, or placebo
1046609|NCT00703885|E1|Reported Event|ALL SUBJECTS RECEIVE ALL 3 TREATMENTS|Alprazolam Low Dose Alprazolam High Dose Placebo
1046610|NCT00703846|B1|Baseline|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and twice a day (morning and evening [BD]) to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
1046611|NCT00703846|P1|Participant Flow|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied twice a day (morning and evening [BD]) to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. The maximum treatment period was 12 months.
1046612|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
1046613|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
1046700|NCT00703508|O2|Outcome|C/G Genotype|Metformin tablet, 500 mg per tablet, 2 tablets every 12 hours
1046614|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
1046615|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
1046616|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
1046617|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
1046618|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
1046619|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
1046620|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
1046621|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
1046622|NCT00703846|O1|Outcome|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and BD to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
1046623|NCT00703846|E1|Reported Event|Extina (Ketoconazole) 2%|Extina (ketoconazole) Foam, 2% was topically applied at the first sign of a seborrheic dermatitis flare, and twice a day (morning and evening [BD]) to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until the areas were cleared. All symptom flares were treated throughout the 12-month study period.
1046624|NCT00703781|B3|Baseline|Total|Total of all reporting groups
1046625|NCT00703781|B2|Baseline|Placebo|Placebo, Dosed 1 Drop Daily
1046626|NCT00703781|B1|Baseline|Bromfenac|Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily
1046627|NCT00703781|P2|Participant Flow|Placebo|Placebo, Dosed 1 Drop Daily
1046628|NCT00703781|P1|Participant Flow|Bromfenac|Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily
1046629|NCT00703781|O2|Outcome|Placebo|Placebo, Dosed 1 Drop Daily
1046630|NCT00703781|O1|Outcome|Bromfenac|Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily
1046631|NCT00703781|O2|Outcome|Placebo|Placebo, Dosed 1 Drop Daily
1046632|NCT00703781|O1|Outcome|Bromfenac|Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily
1046633|NCT00703781|E2|Reported Event|Placebo|Placebo, Dosed 1 Drop Daily
1046634|NCT00703781|E1|Reported Event|Bromfenac|Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily
1046635|NCT00703729|B3|Baseline|Total|Total of all reporting groups
1046636|NCT00703729|B2|Baseline|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046637|NCT00703729|B1|Baseline|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046638|NCT00703729|P2|Participant Flow|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046701|NCT00703508|O1|Outcome|G/G Genotype|Metformin tablet, 500 mg per tablet, 2 tablets every 12 hours
1046702|NCT00703508|O3|Outcome|C/C Genotype|Metformin tablet, 500 mg per tablet, 2 tablets every 12 hours
1046703|NCT00703508|O2|Outcome|C/G Genotype|Metformin tablet, 500 mg per tablet, 2 tablets every 12 hours
1046704|NCT00703508|O1|Outcome|G/G Genotype|Metformin tablet, 500 mg per tablet, 2 tablets every 12 hours
1046639|NCT00703729|P1|Participant Flow|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046640|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046641|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046642|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046643|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046644|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046645|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046646|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046647|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046648|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046649|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046650|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046651|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046652|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046653|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046654|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046655|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046656|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046657|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046658|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046659|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046660|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046661|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046662|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046663|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046664|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046665|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046666|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046667|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046668|NCT00703729|O2|Outcome|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046669|NCT00703729|O1|Outcome|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046670|NCT00703729|E2|Reported Event|Ice Wrap (IW)|"The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period~Ice Wrap (IW): The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046671|NCT00703729|E1|Reported Event|Cold Compression (CC)|"The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.~Cold Compression (CC): The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours."
1046672|NCT00703677|B1|Baseline|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
1046673|NCT00703677|P1|Participant Flow|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
1046674|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
1046675|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
1046676|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
1046677|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
1046678|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
1046679|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
1046680|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
1046681|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
1046682|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
1046683|NCT00703677|O1|Outcome|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
1046684|NCT00703677|E1|Reported Event|Lithium Carbonate|All participants will receive lithium in this open label study (single arm). Dosages will be determined in advance to achieve serum concentrations of 0.4-0.6, 0.6-0.8, 0.8-1.0, and 1.0-1.2 mEq/L.
1046685|NCT00703534|B3|Baseline|Total|Total of all reporting groups
1046686|NCT00703534|B2|Baseline|Placebo|Placebo capsules twice daily, Gelusil tablets as rescue medication if needed
1046687|NCT00703534|B1|Baseline|AZD3355|AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
1046688|NCT00703534|P2|Participant Flow|Placebo|Placebo capsules twice daily, Gelusil tablets as rescue medication if needed
1046689|NCT00703534|P1|Participant Flow|AZD3355|AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
1046690|NCT00703534|O2|Outcome|Placebo|Placebo capsules twice daily, Gelusil tablets as rescue medication if needed
1046691|NCT00703534|O1|Outcome|AZD3355|AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
1046692|NCT00703534|E2|Reported Event|Placebo|Placebo capsules twice daily, Gelusil tablets as rescue medication if needed
1046693|NCT00703534|E1|Reported Event|AZD3355|AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed
1046694|NCT00703508|B1|Baseline|Metformin|"Metformin tablet, 500 mg/tablet, 2 tablets every twelve hours, 9 months duration~Metformin 500 mg tablet: Metformin 500 mg tablets; two tablets every 12 hours for 9 months"
1046695|NCT00703508|P1|Participant Flow|Metformin|"Metformin tablet, 500 mg/tablet, 2 tablets every twelve hours, 9 months duration~Metformin 500 mg tablet: Metformin 500 mg tablets; two tablets every 12 hours for 9 months"
1046696|NCT00703508|O3|Outcome|C/C Genotype|Metformin tablet, 500 mg per tablet, 2 tablets every 12 hours
1046697|NCT00703508|O2|Outcome|C/G Genotype|Metformin tablet, 500 mg per tablet, 2 tablets every 12 hours
1046705|NCT00703508|E1|Reported Event|Metformin|"Metformin tablet, 500 mg/tablet, 2 tablets every twelve hours, 9 months duration~Metformin 500 mg tablet: Metformin 500 mg tablets; two tablets every 12 hours for 9 months"
1046706|NCT00703391|B3|Baseline|Total|Total of all reporting groups
1046707|NCT00703391|B2|Baseline|Placebo|Matched placebo tablets twice daily (bid) for 14 days
1046708|NCT00703391|B1|Baseline|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
1046709|NCT00703391|P2|Participant Flow|Placebo|Matched placebo tablets twice daily (bid) for 14 days
1046710|NCT00703391|P1|Participant Flow|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
1046711|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
1046712|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
1046713|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
1046714|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
1046715|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
1046716|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
1046717|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
1046718|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
1046719|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
1046720|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
1046721|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
1046722|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
1046723|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
1046724|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
1046725|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
1046726|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
1046727|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
1046728|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
1046729|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
1046730|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
1046731|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
1046732|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
1046733|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
1046734|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
1046735|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
1046736|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
1046737|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
1046738|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
1046739|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
1046740|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
1046741|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
1046742|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
1046743|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
1046744|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
1046745|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
1046746|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
1046747|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
1046748|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
1046749|NCT00703391|O2|Outcome|Placebo|Matched placebo tablets twice daily (bid) for 14 days
1046750|NCT00703391|O1|Outcome|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
1046751|NCT00703391|E2|Reported Event|Placebo|Matched placebo tablets twice daily (bid) for 14 days
1046752|NCT00703391|E1|Reported Event|AZD9668|AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
1046753|NCT00703339|B1|Baseline|18mcg Inhaled Treprostinil Cohort|"Patients are to be divided in four cohorts of four patients each. The first cohort will receive a single dose of inhaled Treprostinil (18ug) and each subsequent cohort will receive increasing single doses of 36, 54 and 72ug.~Each patient will be evaluated on a screening visit (Visit 1) within 28 days prior to dosing, a confirmatory visit (Visit 2) within 14 days prior to dosing, a Baseline/Treatment/Post-Treatment visit( Visit 3) on the dosing day and a Follow-up Period (visit 4) for up to 5 days after dosing."
1046754|NCT00703339|P1|Participant Flow|18mcg Inhaled Treprostinil Cohort|"Patients are to be divided in four cohorts of four patients each. The first cohort will receive a single dose of inhaled Treprostinil (18ug) and each subsequent cohort will receive increasing single doses of 36, 54 and 72ug.~Each patient will be evaluated on a screening visit (Visit 1) within 28 days prior to dosing, a confirmatory visit (Visit 2) within 14 days prior to dosing, a Baseline/Treatment/Post-Treatment visit( Visit 3) on the dosing day and a Follow-up Period (visit 4) for up to 5 days after dosing."
1046755|NCT00703339|O1|Outcome|18mcg Inhaled Treprostinil Cohort|Number of participates on a dose of three 6mcg breaths (18mcg total)with Adverse Events
1046756|NCT00703339|E1|Reported Event|18mcg Inhaled Treprostinil Cohort|"Patients are to be divided in four cohorts of four patients each. The first cohort will receive a single dose of inhaled Treprostinil (18ug) and each subsequent cohort will receive increasing single doses of 36, 54 and 72ug.~Each patient will be evaluated on a screening visit (Visit 1) within 28 days prior to dosing, a confirmatory visit (Visit 2) within 14 days prior to dosing, a Baseline/Treatment/Post-Treatment visit( Visit 3) on the dosing day and a Follow-up Period (visit 4) for up to 5 days after dosing."
1046758|NCT00703326|B2|Baseline|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
1046759|NCT00703326|B1|Baseline|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
1046760|NCT00703326|P2|Participant Flow|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
1046761|NCT00703326|P1|Participant Flow|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
1046762|NCT00703326|O2|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day~1 of each 21-day cycle."
1046763|NCT00703326|O1|Outcome|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
1046764|NCT00703326|O2|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
1046765|NCT00703326|O1|Outcome|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
1046766|NCT00703326|O2|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
1046767|NCT00703326|O1|Outcome|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
1046768|NCT00703326|O2|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
1046769|NCT00703326|O1|Outcome|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
1046770|NCT00703326|O2|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
1046771|NCT00703326|O1|Outcome|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
1046772|NCT00703326|O2|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
1046773|NCT00703326|O1|Outcome|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
1046774|NCT00703326|O2|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
1046775|NCT00703326|O1|Outcome|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
1046776|NCT00703326|O2|Outcome|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
1046777|NCT00703326|O1|Outcome|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
1046778|NCT00703326|E2|Reported Event|Placebo + Docetaxel|"Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m2) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
1046779|NCT00703326|E1|Reported Event|Ramucirumab (IMC-1121B) + Docetaxel|"Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.~Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m2) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle."
1046780|NCT00703261|B3|Baseline|Total|Total of all reporting groups
1046781|NCT00703261|B2|Baseline|80 mg Atorvastatin|Participants self-administered one 80 mg atorvastatin tablet and one 10 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
1046782|NCT00703261|B1|Baseline|10 mg Atorvastatin|Participants self-administered one 10 mg atorvastatin tablet and one 80 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
1046783|NCT00703261|P2|Participant Flow|80 mg Atorvastatin|Participants self-administered one 80 mg atorvastatin tablet and one 10 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
1046784|NCT00703261|P1|Participant Flow|10 mg Atorvastatin|Participants self-administered one 10 mg atorvastatin tablet and one 80 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
1046785|NCT00703261|O1|Outcome|Statin-Naive Participants|Participants self-administered one 10 mg or 80 mg atorvastatin tablet and one matching 80 mg or 10 mg atorvastatin placebo tablet orally once daily for 12 weeks.
1046786|NCT00703261|O2|Outcome|80 mg Atorvastatin|Participants self-administered one 80 mg atorvastatin tablet and one matching 10 mg atorvastatin placebo tablet orally once daily for 12 weeks.
1046787|NCT00703261|O1|Outcome|10 mg Atorvastatin|Participants self-administered one 10 mg atorvastatin tablet and one matching 80 mg atorvastatin placebo tablet orally once daily for 12 weeks.
1046788|NCT00703261|E2|Reported Event|80 mg Atorvastatin|Participants self-administered one 80 mg atorvastatin tablet and one 10 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
1046789|NCT00703261|E1|Reported Event|10 mg Atorvastatin|Participants self-administered one 10 mg atorvastatin tablet and one 80 mg atorvastatin matching placebo tablet orally once daily for 12 weeks.
1046790|NCT00703157|B3|Baseline|Total|Total of all reporting groups
1046791|NCT00703157|B2|Baseline|Surgery|Surgical Ablation
1046792|NCT00703157|B1|Baseline|Catheter|Catheter Ablation
1046793|NCT00703157|P2|Participant Flow|Surgery|Surgical Ablation
1046794|NCT00703157|P1|Participant Flow|Catheter|Catheter Ablation
1046795|NCT00703157|O2|Outcome|Surgery|Surgical Ablation
1046796|NCT00703157|O1|Outcome|Catheter|Catheter Ablation
1046797|NCT00703157|O2|Outcome|Surgery|Surgical Ablation
1046798|NCT00703157|O1|Outcome|Catheter|Catheter Ablation
1046799|NCT00703157|O2|Outcome|Surgery|Surgical Ablation
1046800|NCT00703157|O1|Outcome|Catheter|Catheter Ablation
1046801|NCT00703157|O2|Outcome|Surgery|Surgical Ablation
1046802|NCT00703157|O1|Outcome|Catheter|Catheter Ablation
1046803|NCT00703157|O2|Outcome|Surgery|Surgical Ablation
1046804|NCT00703157|O1|Outcome|Catheter|Catheter Ablation
1046805|NCT00703157|O2|Outcome|Surgery|Surgical Ablation
1046806|NCT00703157|O1|Outcome|Catheter|Catheter Ablation
1046807|NCT00703157|O2|Outcome|Surgery|Surgical Ablation
1046808|NCT00703157|O1|Outcome|Catheter|Catheter Ablation
1046809|NCT00703157|O3|Outcome|All Subjects|All Subjects, regardless of randomization group
1046810|NCT00703157|O2|Outcome|Surgery|Surgical Ablation
1046811|NCT00703157|O1|Outcome|Catheter|Catheter Ablation
1046812|NCT00703157|O3|Outcome|All Subjects|All Subjects, regardless of randomization group
1046813|NCT00703157|O2|Outcome|Surgery|Surgical Ablation
1046814|NCT00703157|O1|Outcome|Catheter|Catheter Ablation
1046815|NCT00703157|O3|Outcome|All Subjects|All Subjects, regardless of randomization group
1046816|NCT00703157|O2|Outcome|Surgery|Surgical Ablation
1046817|NCT00703157|O1|Outcome|Catheter|Catheter Ablation
1046818|NCT00703157|O3|Outcome|All Subjects|All Subjects, regardless of randomization group
1046819|NCT00703157|O2|Outcome|Surgery|Surgical Ablation
1046820|NCT00703157|O1|Outcome|Catheter|Catheter Ablation
1046821|NCT00703157|E3|Reported Event|All Randomized Subjects|All Randomized Subjects, regardless of randomization group
1046822|NCT00703157|E2|Reported Event|Surgery|Surgical Ablation
1046823|NCT00703157|E1|Reported Event|Catheter|Catheter Ablation
1046824|NCT00703118|B4|Baseline|Total|Total of all reporting groups
1046825|NCT00703118|B3|Baseline|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
1046826|NCT00703118|B2|Baseline|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
1046827|NCT00703118|B1|Baseline|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
1046828|NCT00703118|P3|Participant Flow|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
1046829|NCT00703118|P2|Participant Flow|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
1046830|NCT00703118|P1|Participant Flow|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
1046831|NCT00703118|O3|Outcome|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
1046832|NCT00703118|O2|Outcome|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
1046833|NCT00703118|O1|Outcome|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
1046834|NCT00703118|O3|Outcome|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
1046835|NCT00703118|O2|Outcome|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
1046836|NCT00703118|O1|Outcome|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
1046839|NCT00703118|O1|Outcome|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
1046840|NCT00703118|O2|Outcome|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
1046841|NCT00703118|O1|Outcome|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
1046842|NCT00703118|O3|Outcome|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
1046843|NCT00703118|O2|Outcome|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
1046844|NCT00703118|O1|Outcome|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
1046845|NCT00703118|O3|Outcome|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
1046846|NCT00703118|O2|Outcome|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
1046847|NCT00703118|O1|Outcome|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
1046848|NCT00703118|O3|Outcome|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
1046849|NCT00703118|O2|Outcome|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
1046850|NCT00703118|O1|Outcome|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
1046851|NCT00703118|O3|Outcome|Pbo/PR48|48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
1046852|NCT00703118|O2|Outcome|T12(DS)/PR48|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
1046853|NCT00703118|O1|Outcome|T12/PR48|12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses
1046854|NCT00703118|E6|Reported Event|Pbo/PR48 - OVERALL TREATMENT|48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the overall treatment phase
1046855|NCT00703118|E5|Reported Event|T12(DS)/PR48 - OVERALL TREATMENT|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir q8hr in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AES during the overall treatment phase
1046856|NCT00703118|E4|Reported Event|T12/PR48 - OVERALL TREATMENT|12 weeks of 750 mg telaprevir q8hr followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AES during the overall treatment phase
1046857|NCT00703118|E3|Reported Event|Pbo/PR48 - TVR/PBO TREATMENT|48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the telaprevir/placebo treatment phase
1046858|NCT00703118|E2|Reported Event|T12(DS)/PR48 - TVR/PBO TREATMENT|4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir q8hr in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the telaprevir/placebo treatment phase
1046859|NCT00703118|E1|Reported Event|T12/PR48 - TVR/PBO TREATMENT|12 weeks of 750 mg telaprevir q8hr followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the telaprevir/placebo treatment phase
1046860|NCT00703092|B1|Baseline|Fiber-Stat|"2 tablespoons daily~Fiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily."
1046861|NCT00703092|P1|Participant Flow|Fiber-Stat|"2 tablespoons daily~Fiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily."
1046862|NCT00703092|O1|Outcome|Fiber-Stat|"2 tablespoons daily~Fiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily."
1046863|NCT00703092|E1|Reported Event|Fiber-Stat|"2 tablespoons daily~Fiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily."
1046864|NCT00703053|B10|Baseline|Total|Total of all reporting groups
1046865|NCT00703053|B9|Baseline|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046866|NCT00703053|B8|Baseline|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046867|NCT00703053|B7|Baseline|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046868|NCT00703053|B6|Baseline|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046869|NCT00703053|B5|Baseline|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
1046870|NCT00703053|B4|Baseline|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046871|NCT00703053|B3|Baseline|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046872|NCT00703053|B2|Baseline|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1056694|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1047431|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
1046873|NCT00703053|B1|Baseline|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046874|NCT00703053|P9|Participant Flow|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046875|NCT00703053|P8|Participant Flow|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046876|NCT00703053|P7|Participant Flow|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046877|NCT00703053|P6|Participant Flow|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046878|NCT00703053|P5|Participant Flow|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
1046879|NCT00703053|P4|Participant Flow|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046880|NCT00703053|P3|Participant Flow|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046881|NCT00703053|P2|Participant Flow|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046882|NCT00703053|P1|Participant Flow|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046883|NCT00703053|O3|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046884|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046885|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046886|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046887|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046888|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046889|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046890|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
1046891|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046892|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046893|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046894|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046895|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046896|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046897|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046898|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1047427|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
1046899|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
1046900|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046901|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046902|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046903|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046904|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046905|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046906|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046907|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046908|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
1046909|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046910|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046911|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046912|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046913|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046914|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046915|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046916|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046917|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
1046918|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046919|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046920|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046921|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046922|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046923|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046924|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046925|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046926|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
1046927|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046928|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046929|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046930|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046931|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046932|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046933|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046934|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046935|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
1046936|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046937|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046938|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046939|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046940|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046941|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046942|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046943|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046944|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
1046945|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046946|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046947|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046948|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046949|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046950|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046951|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046952|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046953|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
1046954|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046955|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046956|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046957|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046958|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046959|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046960|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046961|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046962|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
1046963|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046964|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046965|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046966|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046967|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046968|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046969|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046970|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046971|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
1046972|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046973|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046974|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046975|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1047428|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
1046976|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046977|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046978|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046979|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046980|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
1046981|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046982|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046983|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046984|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046985|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046986|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046987|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046988|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046989|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
1046990|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046991|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046992|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046993|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046994|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046995|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1046996|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046997|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1046998|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
1046999|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1047000|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1047001|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1047002|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1047003|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1047004|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1047005|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1047006|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1047007|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
1047008|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1047009|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1047010|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1047011|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1047012|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1047013|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1047014|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1047015|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1047016|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
1047017|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1047018|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1047019|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1047020|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1047021|NCT00703053|O8|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1047022|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1047023|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1047024|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
1047025|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1047026|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1047429|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
1047027|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1047028|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1047029|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1047030|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1047031|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1047032|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1047033|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
1047034|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1047035|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1047036|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1047037|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1047038|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1047039|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1047040|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1047041|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1047042|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
1047043|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1047044|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1047045|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1047046|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1047047|NCT00703053|O9|Outcome|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1047048|NCT00703053|O8|Outcome|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1047049|NCT00703053|O7|Outcome|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1047050|NCT00703053|O6|Outcome|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1047051|NCT00703053|O5|Outcome|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
1047052|NCT00703053|O4|Outcome|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1047053|NCT00703053|O3|Outcome|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1047054|NCT00703053|O2|Outcome|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1047055|NCT00703053|O1|Outcome|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1047056|NCT00703053|E9|Reported Event|VN/VN, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1047057|NCT00703053|E8|Reported Event|VN, Day 0|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1047058|NCT00703053|E7|Reported Event|I/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1047059|NCT00703053|E6|Reported Event|VN/I, Day 0, 180|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1047060|NCT00703053|E5|Reported Event|VN+I/VN+I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
1047061|NCT00703053|E4|Reported Event|VN/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1047062|NCT00703053|E3|Reported Event|I/I, Day 0, 28|Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
1047063|NCT00703053|E2|Reported Event|VN/VN, Day 0, 14|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1047064|NCT00703053|E1|Reported Event|VN/VN, Day 0, 7|Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
1047065|NCT00703014|B3|Baseline|Total|Total of all reporting groups
1047066|NCT00703014|B2|Baseline|Mothers recFSH 200 IU|Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
1047067|NCT00703014|B1|Baseline|Mothers Corifollitropin Alfa 150 µg|Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
1047068|NCT00703014|P4|Participant Flow|Fetuses/Infants recFSH 200 IU|Fetuses and infants born in Follow Up Trial P05712 to mothers treated with recFSH 200 IU in Base Trial P05787 (NCT00696800)
1047069|NCT00703014|P3|Participant Flow|Fetuses/Infants Corifollitropin Alfa 150 µg|Fetuses and infants born in Follow Up Trial P05712 to mothers treated with Corifollitropin Alfa 150 µg in Base Trial P05787 (NCT00696800)
1047070|NCT00703014|P2|Participant Flow|Mothers recFSH 200 IU|Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
1047071|NCT00703014|P1|Participant Flow|Mothers Corifollitropin Alfa 150 µg|Participants from the Base Trial P05787 (NCT00696800) who received a subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of human Chorion Gonadotropin (hCG); multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of oocyte pick-up (OPU) daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
1047430|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
1047072|NCT00703014|O2|Outcome|Mothers recFSH 200 IU|Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
1047073|NCT00703014|O1|Outcome|Mothers Corifollitropin Alfa 150 µg|Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
1047074|NCT00703014|O2|Outcome|Mothers recFSH 200 IU|Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
1047075|NCT00703014|O1|Outcome|Mothers Corifollitropin Alfa 150 µg|Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
1047076|NCT00703014|O2|Outcome|Infants recFSH 200 IU|Infants born in Follow Up Trial P05712 to mothers treated with recFSH 200 IU in Base Trial P05787 (NCT00696800)
1047077|NCT00703014|O1|Outcome|Infants Corifollitropin Alfa 150 µg|Infants born in Follow Up Trial P05712 to mothers treated with Corifollitropin Alfa 150 µg in Base Trial P05787 (NCT00696800)
1047078|NCT00703014|O2|Outcome|Infants recFSH 200 IU|Infants born in Follow Up Trial P05712 to mothers treated with recFSH 200 IU in Base Trial P05787 (NCT00696800)
1047079|NCT00703014|O1|Outcome|Infants Corifollitropin Alfa 150 µg|Infants born in Follow Up Trial P05712 to mothers treated with Corifollitropin Alfa 150 µg in Base Trial P05787 (NCT00696800)
1047080|NCT00703014|O2|Outcome|Mothers recFSH 200 IU|Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
1047081|NCT00703014|O1|Outcome|Mothers Corifollitropin Alfa 150 µg|Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
1047082|NCT00703014|O2|Outcome|Mothers recFSH 200 IU|Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
1047083|NCT00703014|O1|Outcome|Mothers Corifollitropin Alfa 150 µg|Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
1047084|NCT00703014|E4|Reported Event|Fetuses/Infants recFSH 200 IU|Fetuses and infants born in Follow Up Trial P05712 to mothers treated with recFSH 200 IU in Base Trial P05787 (NCT00696800)
1047085|NCT00703014|E3|Reported Event|Fetuses/Infants Corifollitropin Alfa 150 µg|Fetuses and infants born in Follow Up Trial P05712 to mothers treated with Corifollitropin Alfa 150 µg in Base Trial P05787 (NCT00696800)
1047086|NCT00703014|E2|Reported Event|Mothers recFSH 200 IU|Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
1047087|NCT00703014|E1|Reported Event|Mothers Corifollitropin Alfa 150 µg|Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
1047088|NCT00702949|B4|Baseline|Total|Total of all reporting groups
1047089|NCT00702949|B3|Baseline|Placebo|Patients receive oral placebo twice daily for 6 weeks.
1047090|NCT00702949|B2|Baseline|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
1047091|NCT00702949|B1|Baseline|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
1047092|NCT00702949|P3|Participant Flow|Placebo|Patients receive oral placebo twice daily for 6 weeks.
1047093|NCT00702949|P2|Participant Flow|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
1047094|NCT00702949|P1|Participant Flow|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
1047095|NCT00702949|O3|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
1047096|NCT00702949|O2|Outcome|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
1047097|NCT00702949|O1|Outcome|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
1047098|NCT00702949|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
1047099|NCT00702949|O1|Outcome|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
1047100|NCT00702949|O3|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
1047101|NCT00702949|O2|Outcome|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
1047102|NCT00702949|O1|Outcome|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
1047103|NCT00702949|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
1047104|NCT00702949|O1|Outcome|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
1047105|NCT00702949|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
1047106|NCT00702949|O1|Outcome|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
1047107|NCT00702949|O3|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
1047108|NCT00702949|O2|Outcome|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
1047109|NCT00702949|O1|Outcome|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
1047110|NCT00702949|O3|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
1047111|NCT00702949|O2|Outcome|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
1047112|NCT00702949|O1|Outcome|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
1047113|NCT00702949|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 weeks.
1047114|NCT00702949|O1|Outcome|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
1047115|NCT00702949|E3|Reported Event|Placebo|Patients receive oral placebo twice daily for 6 weeks.
1047116|NCT00702949|E2|Reported Event|Pregabalin150|Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
1047117|NCT00702949|E1|Reported Event|Pregabalin75|Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
1047118|NCT00702923|B1|Baseline|CP-675,206 in Combination With Short Term Androgen Deprivation|Bicalutamide 150mg orally days 1-28 followed by CP-675,206 IV on day 29. Cycle is repeated once at month 3
1047119|NCT00702923|P1|Participant Flow|CP-675,206 in Combination With Short Term Androgen Deprivation|Bicalutamide 150mg orally days 1-28 followed by CP-675,206 IV on day 29. Cycle is repeated once at month 3
1047120|NCT00702923|O2|Outcome|CP-675,206 6mg/kg|Dose level 1: Bicalutamide 150mg orally once a day on days 1-28 and CP-675,206 6mg/kg intravenously over 1 hour on day 29. The treatment is repeated at month 3 (beginning day 85).
1047121|NCT00702923|O1|Outcome|CP-675,206 3mg/kg|Dose level -1: Bicalutamide 150mg orally once a day on days 1-28 and CP-675,206 3mg/kg intravenously over 1 hour on day 29. The treatment is repeated at month 3 (beginning day 85).
1047122|NCT00702923|O2|Outcome|CP-675,206 6mg/kg|Dose level 1: Bicalutamide 150mg orally once a day on days 1-28 and CP-675,206 6mg/kg intravenously over 1 hour on day 29. The treatment is repeated at month 3 (beginning day 85).
1047123|NCT00702923|O1|Outcome|CP-675,206 3mg/kg|Dose level -1: Bicalutamide 150mg orally once a day on days 1-28 and CP-675,206 3mg/kg intravenously over 1 hour on day 29. The treatment is repeated at month 3 (beginning day 85).
1047124|NCT00702923|O2|Outcome|CP-675,206 6mg/kg|Dose level 1: Bicalutamide 150mg orally once a day on days 1-28 and CP-675,206 6mg/kg intravenously over 1 hour on day 29. The treatment is repeated at month 3 (beginning day 85).
1047125|NCT00702923|O1|Outcome|CP-675,206 3mg/kg|Dose level -1: Bicalutamide 150mg orally once a day on days 1-28 and CP-675,206 3mg/kg intravenously over 1 hour on day 29. The treatment is repeated at month 3 (beginning day 85).
1047126|NCT00702923|E1|Reported Event|CP-675,206 in Combination With Short Term Androgen Deprivation|Bicalutamide 150mg orally days 1-28 followed by CP-675,206 IV on day 29. Cycle is repeated once at month 3
1047127|NCT00702884|B1|Baseline|Sunitinib|"Sunitinib 37.5 mg daily for a 4 week cycle~sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle"
1047128|NCT00702884|P1|Participant Flow|Sunitinib|"Sunitinib 37.5 mg daily for a 4 week cycle~sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle"
1047129|NCT00702884|O1|Outcome|Sunitinib|"Sunitinib 37.5 mg daily for a 4 week cycle~sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle"
1047130|NCT00702884|O1|Outcome|Sunitinib|"Sunitinib 37.5 mg daily for a 4 week cycle~sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle"
1047131|NCT00702884|O3|Outcome|Grade 4 Adverse Events|Grade 4=Life-threatening consequences; urgent intervention indicated
1047132|NCT00702884|O2|Outcome|Grade 3 Adverse Events|Grade 3=Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated
1047133|NCT00702884|O1|Outcome|Grade 1 and 2 Adverse Events|"Grade 1=Mild; asymptomatic or mild symptoms~Grade 2=Moderate; minimal, local or noninvasive intervention indicated"
1047134|NCT00702884|O1|Outcome|Sunitinib|"Sunitinib 37.5 mg daily for a 4 week cycle~sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle"
1047135|NCT00702884|O1|Outcome|Sunitinib|"Sunitinib 37.5 mg daily for a 4 week cycle~sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle"
1047136|NCT00702884|O1|Outcome|Sunitinib|"Sunitinib 37.5 mg daily for a 4 week cycle~sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle"
1047137|NCT00702884|O1|Outcome|Sunitinib|"Sunitinib 37.5 mg daily for a 4 week cycle~sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle"
1047138|NCT00702884|E1|Reported Event|Sunitinib|"Sunitinib 37.5 mg daily for a 4 week cycle~sunitinib malate: Sunitinib 37.5 mg daily for a 4 week cycle"
1047139|NCT00702845|B3|Baseline|Total|Total of all reporting groups
1047140|NCT00702845|B2|Baseline|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
1047141|NCT00702845|B1|Baseline|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
1047142|NCT00702845|P2|Participant Flow|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
1047143|NCT00702845|P1|Participant Flow|100 μg Corifollitropin Alfa|Participants received a single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recombinant Follicle Stimulating Hormone (recFSH) injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of Human Chorion Gonadotropin (hCG) administration. Participants also received Gonadotropin Releasing Hormone (GnRH) antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular [IM] injection), starting on day of oocyte pick-up (OPU) and continuing for at least 6 weeks or up to menses.
1047144|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
1047145|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
1047206|NCT00702715|P1|Participant Flow|Participants With Severe Renal Impairment|Participants with severe renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 post-tetanic counts (PTC). Severe renal impairment was defined as creatinine clearance <30mL/min.
1047207|NCT00702715|O2|Outcome|Participants With Normal Renal Function|Participants with normal renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Normal renal function was defined as creatinine clearance >=80mL/min.
1047146|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
1047147|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
1047148|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
1047149|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
1047150|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
1047151|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
1047152|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
1047153|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
1047154|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
1047155|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
1047412|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
1047156|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
1047157|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
1047158|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
1047159|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
1047160|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
1047161|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
1047162|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
1047163|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
1047164|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
1047165|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
1047413|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
1047166|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
1047167|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
1047168|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
1047169|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
1047170|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
1047171|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
1047172|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
1047173|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
1047174|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
1047175|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
1047414|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
1047176|NCT00702845|O2|Outcome|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
1047177|NCT00702845|O1|Outcome|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
1047178|NCT00702845|E2|Reported Event|150 IU recFSH|Participants received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses.
1047179|NCT00702845|E1|Reported Event|100 μg Corifollitropin Alfa|Participants received a single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing for at least 6 weeks or up to menses.
1047180|NCT00702780|B3|Baseline|Total|Total of all reporting groups
1047181|NCT00702780|B2|Baseline|Placebo|placebo 20mg qd
1047182|NCT00702780|B1|Baseline|Escitalopram|escitalopram 20mg qd
1047183|NCT00702780|P2|Participant Flow|Placebo|placebo 20mg qd
1047184|NCT00702780|P1|Participant Flow|Escitalopram|escitalopram 20mg qd
1047185|NCT00702780|O2|Outcome|Placebo|placebo 20mg qd
1047186|NCT00702780|O1|Outcome|Escitalopram|escitalopram 20mg qd
1047187|NCT00702780|O2|Outcome|Placebo|placebo 20mg qd
1047188|NCT00702780|O1|Outcome|Escitalopram|escitalopram 20mg qd
1047189|NCT00702780|E2|Reported Event|Placebo|Placebo 20mg qd
1047190|NCT00702780|E1|Reported Event|Escitalopram|Escitalopram 20mg qd
1047191|NCT00702754|B1|Baseline|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
1047192|NCT00702754|P1|Participant Flow|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
1047193|NCT00702754|O1|Outcome|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
1047194|NCT00702754|O1|Outcome|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
1047195|NCT00702754|O1|Outcome|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
1047196|NCT00702754|O1|Outcome|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
1047197|NCT00702754|O1|Outcome|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
1047198|NCT00702754|O1|Outcome|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
1047199|NCT00702754|O1|Outcome|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
1047200|NCT00702754|O1|Outcome|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
1047201|NCT00702754|E1|Reported Event|MYOBLOC Open Label Treatment|All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
1047202|NCT00702715|B3|Baseline|Total|Total of all reporting groups
1047203|NCT00702715|B2|Baseline|Participants With Normal Renal Function|Participants with normal renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Normal renal function was defined as creatinine clearance >=80mL/min.
1047204|NCT00702715|B1|Baseline|Participants With Severe Renal Impairment|Participants with severe renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Severe renal impairment was defined as creatinine clearance <30mL/min.
1047205|NCT00702715|P2|Participant Flow|Participants With Normal Renal Function|Participants with normal renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Normal renal function was defined as creatinine clearance >=80mL/min.
1047415|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
1047526|NCT00702143|O3|Outcome|Healthy Controls|cognitively normal (healthy) controls
1047208|NCT00702715|O1|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Severe renal impairment was defined as creatinine clearance <30mL/min.
1047209|NCT00702715|O2|Outcome|Participants With Normal Renal Function|Participants with normal renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Normal renal function was defined as creatinine clearance >=80mL/min.
1047210|NCT00702715|O1|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Severe renal impairment was defined as creatinine clearance <30mL/min.
1047211|NCT00702715|O2|Outcome|Participants With Normal Renal Function|Participants with normal renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Normal renal function was defined as creatinine clearance >=80mL/min.
1047212|NCT00702715|O1|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Severe renal impairment was defined as creatinine clearance <30mL/min.
1047213|NCT00702715|E2|Reported Event|Participants With Normal Renal Function|Participants with normal renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Normal renal function was defined as creatinine clearance >=80mL/min.
1047214|NCT00702715|E1|Reported Event|Participants With Severe Renal Impairment|Participants with severe renal impairment will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC. Severe renal impairment was defined as creatinine clearance <30mL/min.
1047215|NCT00702702|B4|Baseline|Total|Total of all reporting groups
1047216|NCT00702702|B3|Baseline|Placebo|Placebo, 2 placebo capsules daily for 3 months
1047217|NCT00702702|B2|Baseline|50 mg|Proellex 50 mg, 1 - 50 mg capsule and 1 placebo capsule daily for 3 months
1047218|NCT00702702|B1|Baseline|25 mg|Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
1047219|NCT00702702|P1|Participant Flow|All Groups|Proellex 25 mg, 50 mg or placebo
1047220|NCT00702702|O3|Outcome|Placebo|Placebo, 2 placebo capsules daily for 3 months
1047221|NCT00702702|O2|Outcome|50 mg|Proellex 50 mg, 1 - 50 mg capsule and 1 placebo capsule daily for 3 months
1047222|NCT00702702|O1|Outcome|25 mg|Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
1047223|NCT00702702|E3|Reported Event|C Placebo|Placebo, 2 capsules daily for 3 months
1047224|NCT00702702|E2|Reported Event|B 50 mg|Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
1047225|NCT00702702|E1|Reported Event|A 25 mg|Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
1047226|NCT00702689|B1|Baseline|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.~Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
1047227|NCT00702689|P1|Participant Flow|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.~Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
1047228|NCT00702689|O1|Outcome|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.~Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
1047229|NCT00702689|O1|Outcome|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.~Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
1047230|NCT00702689|O1|Outcome|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.~Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
1047231|NCT00702689|O1|Outcome|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.~Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
1047232|NCT00702689|O1|Outcome|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.~Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
1047233|NCT00702689|O1|Outcome|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.~Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
1047234|NCT00702689|O1|Outcome|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.~Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
1047416|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
1047417|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
1047235|NCT00702689|O1|Outcome|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.~Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
1047236|NCT00702689|E1|Reported Event|Imatinib Mesylate in Patients With cGVHD|"Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.~Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)"
1047237|NCT00702650|B1|Baseline|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
1047238|NCT00702650|P1|Participant Flow|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
1047239|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
1047240|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
1047241|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
1047242|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
1047243|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
1047244|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
1047245|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
1047246|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
1047247|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
1047248|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
1047249|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
1047250|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
1047251|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
1047252|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
1047253|NCT00702650|O1|Outcome|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
1047254|NCT00702650|E1|Reported Event|Testosterone MD-Lotion|30 mg to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 120 days.
1047255|NCT00702624|B3|Baseline|Total|Total of all reporting groups
1047256|NCT00702624|B2|Baseline|recFSH 150 IU Expectant Mothers|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
1047257|NCT00702624|B1|Baseline|Corifollitropin Alfa 100 μg Expectant Mothers|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.
1047258|NCT00702624|P4|Participant Flow|recFSH 150 IU Fetuses at 10 Weeks After ET|This group includes fetuses of expectant mothers who were administered recFSH on base study P05690 (NCT00702845). The fetuses were present at 10 weeks after ET in the base study, and expectant mothers were eligible for enrollment in follow up study P05710.
1047259|NCT00702624|P3|Participant Flow|Corifollitropin Alfa 100 μg Fetuses at 10 Weeks After ET|This group includes fetuses of expectant mothers who were administered corifollitropin alfa in base study P05690 (NCT00702845). The fetuses were present at 10 weeks after embryo transfer (ET) in the base study, and expectant mothers were eligible for enrollment in follow up study P05710.
1047260|NCT00702624|P2|Participant Flow|recFSH 150 IU Women/Expectant Mothers|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
1047418|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
1047419|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
1047261|NCT00702624|P1|Participant Flow|Corifollitropin Alfa 100 μg Women/Expectant Mothers|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular [IM] injection), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.
1047262|NCT00702624|O2|Outcome|recFSH 150 IU Follow-Up Infants|Infants that were born to eligible mothers who received SC recFSH plus hCG on base study P05690 (NCT00702845) were followed for safety and efficacy on the current follow-up study (P05710) according to standard practice.
1047263|NCT00702624|O1|Outcome|Corifollitropin Alfa 100 μg Follow-Up Infants|Infants that were born to eligible mothers who received SC corifollitropin alfa plus hCG on base study P05690 (NCT00702845) were followed for safety and efficacy on the current follow-up study (P05710) according to standard practice.
1047264|NCT00702624|O2|Outcome|recFSH 150 IU Follow-Up Infants|Infants that were born to eligible mothers who received SC recFSH plus hCG on base study P05690 (NCT00702845) were followed for safety and efficacy on the current follow-up study (P05710) according to standard practice.
1047265|NCT00702624|O1|Outcome|Corifollitropin Alfa 100 μg Follow-Up Infants|Infants that were born to eligible mothers who received SC corifollitropin alfa plus hCG on base study P05690 (NCT00702845) were followed for safety and efficacy on the current follow-up study (P05710) according to standard practice.
1047266|NCT00702624|O2|Outcome|recFSH 150 IU Expectant Mothers|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
1047267|NCT00702624|O1|Outcome|Corifollitropin Alfa 100 μg Expectant Mothers|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular [IM] injection), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.
1047268|NCT00702624|O2|Outcome|recFSH 150 IU Expectant Mothers|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
1047269|NCT00702624|O1|Outcome|Corifollitropin Alfa 100 μg Expectant Mothers|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.
1047270|NCT00702624|O2|Outcome|recFSH 150 IU Women|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
1047271|NCT00702624|O1|Outcome|Corifollitropin Alfa 100 μg Women|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.
1047420|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
1047272|NCT00702624|E4|Reported Event|recFSH 150 IU Fetuses at 10 Weeks After ET|This group includes fetuses of expectant mothers who were administered recFSH on base study P05690 (NCT00702845). The fetuses were present at 10 weeks after ET in the base study, and expectant mothers were eligible for enrollment in follow up study P05710.
1047273|NCT00702624|E3|Reported Event|Corifollitropin Alfa 100 μg Fetuses at 10 Weeks After ET|This group includes fetuses of expectant mothers who were administered corifollitropin alfa in base study P05690 (NCT00702845). The fetuses were present at 10 weeks after embryo transfer (ET) in the base study, and expectant mothers were eligible for enrollment in follow up study P05710.
1047274|NCT00702624|E2|Reported Event|recFSH 150 IU Expectant Mothers|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
1047275|NCT00702624|E1|Reported Event|Corifollitropin Alfa 100 μg Expectant Mothers|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular [IM] injection), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.
1047276|NCT00702546|B3|Baseline|Total|Total of all reporting groups
1047277|NCT00702546|B2|Baseline|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
1047278|NCT00702546|B1|Baseline|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
1047279|NCT00702546|P2|Participant Flow|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
1047280|NCT00702546|P1|Participant Flow|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recombinant Follicle Stimulating Hormone (recFSH) injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of Human Chorion Gonadotropin (hCG) administration. Participants also received Gonadotropin Releasing Hormone (GnRH) antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of oocyte pick-up (OPU) and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
1047281|NCT00702546|O2|Outcome|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
1047421|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
1047282|NCT00702546|O1|Outcome|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
1047283|NCT00702546|O2|Outcome|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
1047284|NCT00702546|O1|Outcome|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
1047285|NCT00702546|O2|Outcome|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
1047286|NCT00702546|O1|Outcome|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
1047287|NCT00702546|O2|Outcome|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
1047288|NCT00702546|O1|Outcome|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
1047289|NCT00702546|O2|Outcome|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
1047422|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
1047527|NCT00702143|O2|Outcome|MCI Subjects|MCI (mild cognitive impairment)
1047290|NCT00702546|O1|Outcome|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
1047291|NCT00702546|O2|Outcome|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
1047292|NCT00702546|O1|Outcome|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
1047293|NCT00702546|O2|Outcome|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
1047294|NCT00702546|O1|Outcome|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
1047295|NCT00702546|E2|Reported Event|recFSH 150 IU|Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
1047296|NCT00702546|E1|Reported Event|Corifollitropin Alfa 100 μg|Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles.
1047297|NCT00702520|B3|Baseline|Total|Total of all reporting groups
1047298|NCT00702520|B2|Baseline|Expectant Mothers Administered Corifollitropin Alpha 150 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study.
1047299|NCT00702520|B1|Baseline|Expectant Mothers Administered Corifollitropin Alpha 100 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the follow-up P05783 study.
1047423|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
1047424|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
1047300|NCT00702520|P4|Participant Flow|Infants From Mothers Administered Cori. Alpha 150 ug|Infants from mothers who received 150 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study.
1047301|NCT00702520|P3|Participant Flow|Infants From Mothers Administered Corifollitropin Alpha 100 ug|Infants born to mothers who received 100 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study.
1047302|NCT00702520|P2|Participant Flow|Expectant Mothers Administered Corifollitropin Alpha 150 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study.
1047303|NCT00702520|P1|Participant Flow|Expectant Mothers Administered Corifollitropin Alpha 100 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the follow-up P05783 study.
1047304|NCT00702520|O2|Outcome|Expectant Mothers Administered Corifollitropin Alpha 150 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study.
1047305|NCT00702520|O1|Outcome|Expectant Mothers Administered Corifollitropin Alpha 100 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the follow-up P05783 study.
1047306|NCT00702520|O2|Outcome|Infants From Mothers Administered Cori. Alpha 150 ug|Infants from mothers who received 150 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study.
1047307|NCT00702520|O1|Outcome|Infants From Mothers Administered Corifollitropin Alpha 100 ug|Infants born to mothers who received 100 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study.
1047308|NCT00702520|O2|Outcome|Infants From Mothers Administered Cori. Alpha 150 ug|Infants from mothers who received 150 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study.
1047309|NCT00702520|O1|Outcome|Infants From Mothers Administered Corifollitropin Alpha 100 ug|Infants born to mothers who received 100 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study.
1047310|NCT00702520|O2|Outcome|Expectant Mothers Administered Corifollitropin Alpha 150 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study.
1047311|NCT00702520|O1|Outcome|Expectant Mothers Administered Corifollitropin Alpha 100 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the follow-up P05783 study.
1047312|NCT00702520|O2|Outcome|Expectant Mothers Administered Corifollitropin Alpha 150 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study.
1047313|NCT00702520|O1|Outcome|Expectant Mothers Administered Corifollitropin Alpha 100 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the follow-up P05783 study.
1047314|NCT00702520|E4|Reported Event|Fetuses/Infants From Mothers Administered Cori. Alpha 150 ug|Fetuses/Infants from mothers who received 150 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520) according to standard practice. No study medications were administered in the follow-up P05783 study.
1047315|NCT00702520|E3|Reported Event|Fetuses/Infants From Mothers Administered Cori. Alpha 100 ug|Fetuses/Infants from mothers who received 100 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520) according to standard practice. No study medications were administered in the follow-up P05783 study.
1047316|NCT00702520|E2|Reported Event|Expectant Mothers Administered Corifollitropin Alpha 150 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study.
1047317|NCT00702520|E1|Reported Event|Expectant Mothers Administered Corifollitropin Alpha 100 ug|In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the P05783 study (38834, NCT00702520).
1047318|NCT00702507|B1|Baseline|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of diaper dermatitis complicated by candidiasis (DDCC) during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
1047319|NCT00702507|P1|Participant Flow|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of diaper dermatitis complicated by candidiasis (DDCC) during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
1047320|NCT00702507|O1|Outcome|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
1047321|NCT00702507|O1|Outcome|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
1047322|NCT00702507|O1|Outcome|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
1047323|NCT00702507|O1|Outcome|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
1047324|NCT00702507|O1|Outcome|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
1047325|NCT00702507|O1|Outcome|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
1047326|NCT00702507|O1|Outcome|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
1047327|NCT00702507|O1|Outcome|Vusion Treatment|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14. Further, participants were followed for 2 years. If there was a recurrent episode of DDCC during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment.
1047328|NCT00702507|E2|Reported Event|Vusion Follow-up Phase|After the Initial Treatment Phase participants were followed for 2 years. If there was a recurrent episode of diaper dermatitis complicated by candidiasis (DDCC) during the 2-year follow-up period, the participant was treated for 7 days with Vusion ointment containing 0.25 percent miconazole nitrate.
1047329|NCT00702507|E1|Reported Event|Vusion Initial Treatment Phase|Participants were treated with Vusion ointment containing 0.25 percent miconazole nitrate for 7 days. A follow-up post-treatment visit was conducted at Study Day 14.
1047330|NCT00702468|B3|Baseline|Total|Total of all reporting groups
1047331|NCT00702468|B2|Baseline|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
1047332|NCT00702468|B1|Baseline|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
1047333|NCT00702468|P2|Participant Flow|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
1047334|NCT00702468|P1|Participant Flow|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
1047335|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
1047336|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
1047337|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
1047338|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
1047339|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
1047340|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
1047341|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
1047342|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
1047343|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
1047344|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
1047345|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
1047346|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
1047347|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
1047348|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
1047349|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
1047350|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
1047351|NCT00702468|O2|Outcome|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
1047352|NCT00702468|O1|Outcome|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
1047353|NCT00702468|E2|Reported Event|Placebo|Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations in 24 hours.
1047354|NCT00702468|E1|Reported Event|Sativex|Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose of eight actuations in any three hour period and 48 actuations (delat9-tetrahydrocannabinol (THC)130 mg: 27 mg/ml: cannabidiol (CBD) 120 mg) in 24 hours.
1047355|NCT00702403|B1|Baseline|Single Arm Nilotinib Relapse Prophylaxis|Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO QD until day 80 and then nilotinib PO BID on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO BID beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
1047356|NCT00702403|P1|Participant Flow|Single Arm Nilotinib Relapse Prophylaxis|Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO QD until day 80 and then nilotinib PO BID on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO BID beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
1047357|NCT00702403|O1|Outcome|Treatment (Prophylactic Inhibition of BCR-ABL Tyrosine Kinase)|Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO once daily until day 80 and then nilotinib PO twice daily on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO twice daily beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
1047358|NCT00702403|O1|Outcome|Single Arm Nilotinib Relapse Prophylaxis|Beginning after engraftment and blood counts recover (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO once daily until day 80 and then nilotinib PO twice daily on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO twice daily beginning after engraftment and blood counts recover until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
1047359|NCT00702403|O1|Outcome|Treatment (Prophylactic Inhibition of BCR-ABL Tyrosine Kinase)|"Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO once daily until day 80 and then nilotinib PO twice daily on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO twice daily beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.~nilotinib: Given PO~imatinib mesylate: Given PO~pharmacological study: Correlative studies"
1047360|NCT00702403|O1|Outcome|Treatment (Prophylactic Inhibition of BCR-ABL Tyrosine Kinase)|Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO once daily until day 80 and then nilotinib PO twice daily on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO twice daily beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
1047425|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
1047426|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
1056695|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1047361|NCT00702403|O1|Outcome|Single Arm Nilotinib Relapse Prophylaxis|Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO QD until day 80 and then nilotinib PO BID on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO BID beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
1047362|NCT00702403|E1|Reported Event|Single Arm Nilotinib Relapse Prophylaxis|Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO QD until day 80 and then nilotinib PO BID on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO BID beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
1047363|NCT00702377|B3|Baseline|Total|Total of all reporting groups
1047364|NCT00702377|B2|Baseline|OPTIVE Lubricant Eye Drops|OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
1047365|NCT00702377|B1|Baseline|SYSTANE Ultra|SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
1047366|NCT00702377|P2|Participant Flow|OPTIVE Lubricant Eye Drops|OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
1047367|NCT00702377|P1|Participant Flow|SYSTANE Ultra|SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
1047368|NCT00702377|O2|Outcome|OPTIVE Lubricant Eye Drops|OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
1047369|NCT00702377|O1|Outcome|SYSTANE Ultra|SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
1047370|NCT00702377|O2|Outcome|OPTIVE Lubricant Eye Drops|OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
1047371|NCT00702377|O1|Outcome|SYSTANE Ultra|SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
1047372|NCT00702377|O2|Outcome|OPTIVE Lubricant Eye Drops|OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
1047373|NCT00702377|O1|Outcome|SYSTANE Ultra|SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
1047374|NCT00702377|E2|Reported Event|OPTIVE Lubricant Eye Drops|OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
1047375|NCT00702377|E1|Reported Event|SYSTANE Ultra|SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
1047376|NCT00702364|B3|Baseline|Total|Total of all reporting groups
1047377|NCT00702364|B2|Baseline|Placebo|"Placebo twice a day for two weeks~placebo :"
1047378|NCT00702364|B1|Baseline|Atomoxetine|"40mg atomoxetine twice a day for 2 weeks~atomoxetine :"
1047379|NCT00702364|P2|Participant Flow|Placebo|"Placebo twice a day for two weeks~placebo :"
1047380|NCT00702364|P1|Participant Flow|Atomoxetine|"40mg atomoxetine twice a day for 2 weeks~atomoxetine :"
1047381|NCT00702364|O2|Outcome|Placebo|"Placebo twice a day for two weeks~placebo :"
1047382|NCT00702364|O1|Outcome|Atomoxetine|"40mg atomoxetine twice a day for 2 weeks~atomoxetine :"
1047383|NCT00702364|O2|Outcome|Placebo|"Placebo twice a day for two weeks~placebo :"
1047384|NCT00702364|O1|Outcome|Atomoxetine|"40mg atomoxetine twice a day for 2 weeks~atomoxetine :"
1047385|NCT00702364|O2|Outcome|Placebo|"Placebo twice a day for two weeks~placebo :"
1047386|NCT00702364|O1|Outcome|Atomoxetine|"40mg atomoxetine twice a day for 2 weeks~atomoxetine :"
1047387|NCT00702364|O2|Outcome|Placebo|"Placebo twice a day for two weeks~placebo :"
1047388|NCT00702364|O1|Outcome|Atomoxetine|"40mg atomoxetine twice a day for 2 weeks~atomoxetine :"
1047389|NCT00702364|E2|Reported Event|Placebo|"Placebo twice a day for two weeks~placebo :"
1047390|NCT00702364|E1|Reported Event|Atomoxetine|"40mg atomoxetine twice a day for 2 weeks~atomoxetine :"
1047391|NCT00702338|B1|Baseline|Corifollitropin Alfa + hCG Mothers|Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
1047392|NCT00702338|P3|Participant Flow|Corifollitropin Alfa + hCG FU-Infants|Infants that were born to eligible mothers who received SC corifollitropin alfa plus SC hCG on base study P05693 (NCT00697255) were followed for safety and efficacy on the current follow-up study (P05713) according to standard practice.
1047393|NCT00702338|P2|Participant Flow|Corifollitropin Alfa + hCG Mothers|Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
1047394|NCT00702338|P1|Participant Flow|Corifollitropin Alfa + recFSH Mothers|Eligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered).
1047395|NCT00702338|O1|Outcome|Corifollitropin Alfa + hCG FU-Infants|Infants that were born to eligible mothers from study P05693 (NCT00697255) were followed for safety and efficacy on the current study according to standard practice.
1047396|NCT00702338|O1|Outcome|Corifollitropin Alfa + hCG FU-Infants|Infants that were born to eligible mothers who received SC corifollitropin alfa plus SC hCG on base study P05693 (NCT00697255) were followed for safety and efficacy on the current follow-up study (P05713) according to standard practice.
1047397|NCT00702338|O2|Outcome|Corifollitropin Alfa + hCG Mothers|Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
1047398|NCT00702338|O1|Outcome|Corifollitropin Alfa + recFSH Mothers|Eligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered).
1047399|NCT00702338|O2|Outcome|Corifollitropin Alfa + hCG Mothers|Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
1047400|NCT00702338|O1|Outcome|Corifollitropin Alfa + recFSH Mothers|Eligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered).
1047401|NCT00702338|O2|Outcome|Corifollitropin Alfa + hCG Mothers|Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
1047402|NCT00702338|O1|Outcome|Corifollitropin Alfa + recFSH Mothers|Eligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered).
1047403|NCT00702338|O2|Outcome|Corifollitropin Alfa + hCG Mothers|Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
1047404|NCT00702338|O1|Outcome|Corifollitropin Alfa + recFSH Mothers|Eligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered).
1047405|NCT00702338|E2|Reported Event|Corifollitropin Alfa + hCG FU-Infants|Infants that were born to eligible mothers who received SC corifollitropin alfa plus SC hCG on base study P05693 (NCT00697255) were followed for safety and efficacy on the current follow-up study (P05713) according to standard practice.
1047406|NCT00702338|E1|Reported Event|Corifollitropin Alfa + hCG Mothers|Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).
1047407|NCT00702325|B3|Baseline|Total|Total of all reporting groups
1047408|NCT00702325|B2|Baseline|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
1047409|NCT00702325|B1|Baseline|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
1047410|NCT00702325|P2|Participant Flow|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
1047411|NCT00702325|P1|Participant Flow|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
1047432|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
1047433|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
1047434|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
1047435|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
1047436|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
1047437|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
1047438|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
1047439|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
1047440|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
1047441|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
1047442|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
1047443|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
1047444|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
1047445|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
1047446|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
1047447|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
1047448|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
1047449|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
1047450|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
1047451|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
1047452|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
1047453|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
1047454|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
1047455|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
1047456|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
1047457|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
1047458|NCT00702325|O2|Outcome|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
1047459|NCT00702325|O1|Outcome|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
1047460|NCT00702325|E2|Reported Event|Budesonide|Budesonide inhalation dry powder inhaler (DPI) 180 mcg x 2 inhalations, twice daily.
1047461|NCT00702325|E1|Reported Event|Symbicort|Symbicort pressurized metered dose inhaler (pMDI) 160/4.5 mcg x 2 actuations, twice daily.
1047462|NCT00702299|B1|Baseline|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60–1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
1047463|NCT00702299|P1|Participant Flow|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
1047464|NCT00702299|O3|Outcome|Pemetrexed Dose 1,000mg/m2|Level 5 Pemetrexed dose 1,000mg/m2
1047465|NCT00702299|O2|Outcome|Pemetrexed Dose 750 mg/m2|Level 4 Pemetrexed dose 750 mg/m2
1047466|NCT00702299|O1|Outcome|Pemetrexed Dose 500mg/m2|Level 3 Pemetrexed dose 500mg/m2
1047467|NCT00702299|O1|Outcome|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
1047468|NCT00702299|O1|Outcome|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
1047469|NCT00702299|O1|Outcome|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
1047470|NCT00702299|O1|Outcome|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
1047471|NCT00702299|O1|Outcome|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60-1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
1047472|NCT00702299|E1|Reported Event|Receiving Treatment|Dose escalation of day 1 i.p. pemetrexed accrued three patients to each of five dose levels (60–1,000 mg/m2), along with day 2 i.p. cisplatin (75 mg/m2) and day 8 i.p. paclitaxel (60 mg/m2)
1047473|NCT00702273|B3|Baseline|Total|Total of all reporting groups
1047528|NCT00702143|O1|Outcome|AD Subjects|Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria
1047529|NCT00702143|O3|Outcome|Healthy Controls|cognitively normal (healthy) controls
1047530|NCT00702143|O2|Outcome|MCI Subjects|MCI (mild cognitive impairment)
1047668|NCT00701662|P1|Participant Flow|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
1047670|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
1047474|NCT00702273|B2|Baseline|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
1047475|NCT00702273|B1|Baseline|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
1047476|NCT00702273|P2|Participant Flow|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
1047477|NCT00702273|P1|Participant Flow|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent frozen thawed embryo transfer (FTET) cycles.
1047478|NCT00702273|O2|Outcome|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
1047479|NCT00702273|O1|Outcome|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
1047480|NCT00702273|O2|Outcome|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
1047481|NCT00702273|O1|Outcome|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
1047482|NCT00702273|O2|Outcome|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
1047531|NCT00702143|O1|Outcome|AD Subjects|Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria
1047532|NCT00702143|O3|Outcome|Healthy Controls|cognitively normal (healthy) controls
1047533|NCT00702143|O2|Outcome|MCI Subjects|MCI (mild cognitive impairment)
1047669|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
1047483|NCT00702273|O1|Outcome|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
1047484|NCT00702273|O2|Outcome|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
1047485|NCT00702273|O1|Outcome|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
1047486|NCT00702273|O2|Outcome|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
1047487|NCT00702273|O1|Outcome|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
1047488|NCT00702273|O2|Outcome|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
1047489|NCT00702273|O1|Outcome|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
1047490|NCT00702273|O2|Outcome|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
1047491|NCT00702273|O1|Outcome|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
1047534|NCT00702143|O1|Outcome|AD Subjects|Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria
1047535|NCT00702143|E1|Reported Event|All Subjects|All subjects receiving florbetapir F 18 injection
1047536|NCT00701935|B3|Baseline|Total|Total of all reporting groups
1047537|NCT00701935|B2|Baseline|Placebo|Subcutaneous injection of placebo twice a day for 6 months
1047492|NCT00702273|E2|Reported Event|200 IU RecFSH|Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
1047493|NCT00702273|E1|Reported Event|150 µg Corifollitropin Alfa|Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles >= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
1047494|NCT00702234|B1|Baseline|Expectant Mothers - Corifollitropin Alfa 150 µg|In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
1047495|NCT00702234|P2|Participant Flow|Fetuses Present at 10 Weeks After Fresh ET in Base Study|This group includes fetuses associated with expectant mothers who were administered corifollitropin alfa in base study P05714 (NCT00696878) who were enrolled in this follow-up study P05715. The fetuses were present at 10 weeks after fresh ET in base study P05714 and/or at enrollment of the expectant mother in this follow-up study P05715.
1047496|NCT00702234|P1|Participant Flow|Women/Expectant Mothers - Corifollitropin Alfa 150 µg|In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of Gonadotropin Releasing Hormone (GnRH) antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of recombinant Human Chorion Gonadotropin ([rec]hCG) (5,000-10,000 IU/250 µg). Daily dosing with Follicle Stimulating Hormone (FSH) (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
1047497|NCT00702234|O1|Outcome|Live Born Infants|This group includes infants born to mothers who were administered corifollitropin alfa in base study P05714 (NCT00696878) and who were enrolled in this follow-up study P05715. These infants, whose gestation outcome was live birth, are a subgroup of the total number of fetuses that were present at 10 weeks after fresh ET in base study P05714 and/or at enrollment of the expectant mother in this follow-up study P05715. Fetuses not born alive or with unknown outcome are not included in this reporting group.
1047498|NCT00702234|O1|Outcome|Live Born Infants|This group includes infants born to mothers who were administered corifollitropin alfa in base study P05714 (NCT00696878) and who were enrolled in this follow-up study P05715. These infants, whose gestation outcome was live birth, are a subgroup of the total number of fetuses that were present at 10 weeks after fresh ET in base study P05714 and/or at enrollment of the expectant mother in this follow-up study P05715. Fetuses not born alive or with unknown outcome are not included in this reporting group.
1047499|NCT00702234|O1|Outcome|Expectant Mothers - Corifollitropin Alfa 150 µg|In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
1047500|NCT00702234|O1|Outcome|Expectant Mothers - Corifollitropin Alfa 150 µg|In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
1047538|NCT00701935|B1|Baseline|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
1047539|NCT00701935|P2|Participant Flow|Placebo|Subcutaneous injection of placebo twice a day for 6 months
1047540|NCT00701935|P1|Participant Flow|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
1047541|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
1047501|NCT00702234|O1|Outcome|Women - Corifollitropin Alfa 150 µg|In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
1047502|NCT00702234|E2|Reported Event|Fetuses Present at 10 Weeks After Fresh ET in Base Study|This group includes fetuses associated with expectant mothers who were administered corifollitropin alfa in base study P05714 (NCT00696878) who were enrolled in this follow-up study P05715. The fetuses were present at 10 weeks after fresh ET in base study P05714 and/or at enrollment of the expectant mother in this follow-up study P05715.
1047503|NCT00702234|E1|Reported Event|Expectant Mothers - Corifollitropin Alfa 150 µg|In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
1047504|NCT00702221|B3|Baseline|Total|Total of all reporting groups
1047505|NCT00702221|B2|Baseline|CoVaccine HT™ Adjuvant Alone (Control)|"CoVaccine HT™ adjuvant alone~CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
1047506|NCT00702221|B1|Baseline|Angiotensin Therapeutic Vaccine With CoVaccine HT™ Adjuvant|"Angiotensin Therapeutic Vaccine with CoVaccine HT™ adjuvant (an ingredient that may improve the immune response of the vaccine)~Angiotensin Therapeutic Vaccine plus CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
1047507|NCT00702221|P2|Participant Flow|CoVaccine HT™ Adjuvant Alone (Control)|"CoVaccine HT™ adjuvant alone~CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
1047508|NCT00702221|P1|Participant Flow|Angiotensin Therapeutic Vaccine With CoVaccine HT™ Adjuvant|"Angiotensin Therapeutic Vaccine with CoVaccine HT™ adjuvant (an ingredient that may improve the immune response of the vaccine)~Angiotensin Therapeutic Vaccine plus CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
1047509|NCT00702221|O2|Outcome|CoVaccine HT™ Adjuvant Alone (Control)|"CoVaccine HT™ adjuvant alone~CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
1047510|NCT00702221|O1|Outcome|Angiotensin Therapeutic Vaccine + CoVaccine HT™ Adjuvant|"Angiotensin Therapeutic Vaccine + CoVaccine HT™ adjuvant (an ingredient that may improve the immune response of the vaccine)~Angiotensin Therapeutic Vaccine + CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
1047511|NCT00702221|E2|Reported Event|CoVaccine HT™ Adjuvant Alone (Control)|"CoVaccine HT™ adjuvant alone~CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
1047512|NCT00702221|E1|Reported Event|Angiotensin Therapeutic Vaccine With CoVaccine HT™ Adjuvant|"Angiotensin Therapeutic Vaccine with CoVaccine HT™ adjuvant (an ingredient that may improve the immune response of the vaccine)~Angiotensin Therapeutic Vaccine plus CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart"
1047513|NCT00702208|B1|Baseline|Single Arm Study|Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)
1047514|NCT00702208|P1|Participant Flow|Single Arm Study of Delphi Screener|"Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)~All women were asked to self-collect a cervicovaginal lavage using the Screener during the enrollment study visit. The entire visit took approximately 30-40 minutes. Women generally took 5-10 minutes to self-lavage on their own in a private room."
1047515|NCT00702208|O1|Outcome|Single Arm Study of Delphi Screener|"Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)~All women were asked to self-collect a cervicovaginal lavage using the Screener during the enrollment study visit. The entire visit took approximately 30-40 minutes. Women generally took 5-10 minutes to self-lavage on their own in a private room."
1047516|NCT00702208|O1|Outcome|Single Arm Study of Delphi Screener|Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)
1047517|NCT00702208|O1|Outcome|Single Arm Study of Delphi Screener|Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)
1047518|NCT00702208|E1|Reported Event|Single Arm Study|Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk HPV testing for sub-sample)
1047519|NCT00702143|B4|Baseline|Total|Total of all reporting groups
1047520|NCT00702143|B3|Baseline|Healthy Controls|cognitively normal (healthy) controls
1047521|NCT00702143|B2|Baseline|MCI Subjects|MCI (mild cognitive impairment)
1047522|NCT00702143|B1|Baseline|AD Subjects|Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria
1047523|NCT00702143|P3|Participant Flow|Healthy Controls|cognitively normal (healthy) controls
1047524|NCT00702143|P2|Participant Flow|MCI Subjects|MCI (mild cognitive impairment)
1047525|NCT00702143|P1|Participant Flow|AD Subjects|Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria
1047542|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
1047543|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
1047544|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
1047545|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
1047546|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
1047547|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
1047548|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
1047549|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
1047550|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
1047551|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
1047552|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
1047553|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
1047554|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
1047555|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
1047556|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
1047557|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
1047558|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
1047559|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
1047560|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
1047561|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
1047562|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
1047563|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
1047564|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
1047565|NCT00701935|O2|Outcome|Placebo|Subcutaneous injection of placebo twice a day for 6 months
1047566|NCT00701935|O1|Outcome|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
1047567|NCT00701935|E2|Reported Event|Placebo|Subcutaneous injection of placebo twice a day for 6 months
1047568|NCT00701935|E1|Reported Event|Exenatide BID|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months)
1047569|NCT00701805|B5|Baseline|Total|Total of all reporting groups
1047570|NCT00701805|B4|Baseline|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047571|NCT00701805|B3|Baseline|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047572|NCT00701805|B2|Baseline|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047573|NCT00701805|B1|Baseline|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047574|NCT00701805|P4|Participant Flow|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047663|NCT00701675|O1|Outcome|Sertraline 50mg|"sertraline 50mg per day~sertraline 50 mg daily: 50 mg daily"
1047664|NCT00701675|E3|Reported Event|Placebo|"matching placebo~Placebo 50 or 100 mg: matching placebo"
1056696|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1047575|NCT00701805|P3|Participant Flow|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047576|NCT00701805|P2|Participant Flow|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047577|NCT00701805|P1|Participant Flow|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047578|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047579|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047580|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047581|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047582|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047583|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047584|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047585|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047586|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047587|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047588|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047771|NCT00701363|O2|Outcome|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|
1047589|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047590|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047591|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047592|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047593|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047594|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047595|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047596|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047597|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047598|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047599|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047600|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047601|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047602|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047772|NCT00701363|O1|Outcome|Phase 1 Only: Lanreotide Autogel 120 mg|
1047603|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047604|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047605|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047606|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047607|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047608|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047609|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047610|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047611|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047612|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047613|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047614|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047615|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047616|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1048752|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
1047617|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047618|NCT00701805|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047619|NCT00701805|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047620|NCT00701805|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047621|NCT00701805|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047622|NCT00701805|E4|Reported Event|Paricalcitol 4 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047623|NCT00701805|E3|Reported Event|Paricalcitol 4 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047624|NCT00701805|E2|Reported Event|Paricalcitol 2 µg ± 2 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047625|NCT00701805|E1|Reported Event|Paricalcitol 2 µg ± 1 µg|Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
1047626|NCT00701779|B1|Baseline|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.~Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.~Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
1047627|NCT00701779|P1|Participant Flow|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.~Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.~Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
1047628|NCT00701779|O1|Outcome|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.~Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.~Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
1047665|NCT00701675|E2|Reported Event|Sertraline 100mg|"sertraline 100mg per day~sertraline 100 mg daily: 100 mg daily"
1047666|NCT00701675|E1|Reported Event|Sertraline 50mg|"sertraline 50mg per day~sertraline 50 mg daily: 50 mg daily"
1047667|NCT00701662|B1|Baseline|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
1048753|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
1047629|NCT00701779|O1|Outcome|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.~Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.~Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
1047630|NCT00701779|O1|Outcome|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.~Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.~Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
1047631|NCT00701779|O1|Outcome|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.~Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.~Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
1047632|NCT00701779|O1|Outcome|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.~Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.~Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
1047633|NCT00701779|O1|Outcome|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.~Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.~Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
1047634|NCT00701779|E1|Reported Event|Dutasteride|"Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.~Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.~Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis."
1047635|NCT00701727|B1|Baseline|Entire Study Population|Includes groups randomized to receive ezetimibe first and placebo first
1047636|NCT00701727|P2|Participant Flow|Placebo First, Ezetimibe Second|Placebo first for 7 weeks,followed by ezetimibe for 7 weeks
1047637|NCT00701727|P1|Participant Flow|Ezetimibe First, Placebo Second|Ezetimibe first for 7 weeks, followed by placebo for 7 weeks
1047638|NCT00701727|O2|Outcome|Ezetimibe|Ezetimibe 10 mg/day 7 weeks
1047639|NCT00701727|O1|Outcome|Placebo|placebo daily,7 weeks
1047640|NCT00701727|O2|Outcome|Ezetimibe|Ezetimibe 10 mg/day 7 weeks
1047641|NCT00701727|O1|Outcome|Placebo|placebo daily,7 weeks
1047642|NCT00701727|O2|Outcome|Ezetimibe|Ezetimibe 10 mg/day 7 weeks
1047643|NCT00701727|O1|Outcome|Placebo|placebo daily,7 weeks
1047644|NCT00701727|O2|Outcome|Ezetimibe|Ezetimibe 10 mg/day 7 weeks
1047645|NCT00701727|O1|Outcome|Placebo|placebo daily,7 weeks
1047646|NCT00701727|O2|Outcome|Ezetimibe|Ezetimibe 10 mg/day 7 weeks
1047647|NCT00701727|O1|Outcome|Placebo|placebo daily,7 weeks
1047648|NCT00701727|O2|Outcome|Ezetimibe|Ezetimibe 10 mg/day 7 weeks
1047649|NCT00701727|O1|Outcome|Placebo|placebo daily,7 weeks
1047650|NCT00701727|O2|Outcome|Ezetimibe|Ezetimibe 10 mg/day 7 weeks
1047651|NCT00701727|O1|Outcome|Placebo|placebo daily,7 weeks
1047652|NCT00701727|E2|Reported Event|Ezetimibe|ezetimibe, 10 mg/day, for 7 weeks
1047653|NCT00701727|E1|Reported Event|Placebo|Placebo, 10 mg/day, for 7 weeks
1047654|NCT00701675|B4|Baseline|Total|Total of all reporting groups
1047655|NCT00701675|B3|Baseline|Placebo|"matching placebo~Placebo 50 or 100 mg: matching placebo"
1047656|NCT00701675|B2|Baseline|Sertraline 100mg|"sertraline 100mg per day~sertraline 100 mg daily: 100 mg daily"
1047657|NCT00701675|B1|Baseline|Sertraline 50mg|"sertraline 50mg per day~sertraline 50 mg daily: 50 mg daily"
1047658|NCT00701675|P3|Participant Flow|Placebo|"matching placebo~Placebo 50 or 100 mg: matching placebo"
1047659|NCT00701675|P2|Participant Flow|Sertraline 100mg|"sertraline 100mg per day~sertraline 100 mg daily: 100 mg daily"
1047660|NCT00701675|P1|Participant Flow|Sertraline 50mg|"sertraline 50mg per day~sertraline 50 mg daily: 50 mg daily"
1047661|NCT00701675|O3|Outcome|Placebo|"matching placebo~Placebo 50 or 100 mg: matching placebo"
1047662|NCT00701675|O2|Outcome|Sertraline 100mg|"sertraline 100mg per day~sertraline 100 mg daily: 100 mg daily"
1048754|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
1047671|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
1047672|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
1047673|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
1047674|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
1047675|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
1047676|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
1047677|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
1047678|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
1047679|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
1047680|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
1047681|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
1047682|NCT00701662|O1|Outcome|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
1047683|NCT00701662|E1|Reported Event|Vivaglobin|Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
1047684|NCT00701636|B3|Baseline|Total|Total of all reporting groups
1047685|NCT00701636|B2|Baseline|Controls|15 subjects will be enrolled in the standard of care antibiotic group to serve as the controls. Controls will receive no experimental medications or treatments. The purpose of enrolling control patients was to serve as a reference group for intervention patients. Specifically cases and controls will be compared for changes in commonly collected hematologic parameters, creatinine, and CPK. Additionally, parameters collected during anesthesia will be compared. Controls will be matched to the intervention group by age (+/- 10 years), gender, and ethnicity.
1047686|NCT00701636|B1|Baseline|Cases|The first 15 subjects enrolled will receive the intervention drug daptomycin as surgical antibiotic prophylaxis.
1047687|NCT00701636|P2|Participant Flow|Controls|15 subjects will be enrolled in the standard of care antibiotic group to serve as the controls. Controls will receive no experimental medications or treatments. The purpose of enrolling control patients was to serve as a reference group for intervention patients. Specifically cases and controls will be compared for changes in commonly collected hematologic parameters, creatinine, and CPK. Additionally, parameters collected during anesthesia will be compared. Controls will be matched to the intervention group by age (+/- 10 years), gender, and ethnicity.
1047688|NCT00701636|P1|Participant Flow|Cases|The first 15 subjects enrolled will receive the intervention drug daptomycin as surgical antibiotic prophylaxis.
1047689|NCT00701636|O1|Outcome|Cases|The first 15 subjects enrolled will receive the intervention drug daptomycin as surgical antibiotic prophylaxis for CABG.
1047690|NCT00701636|E2|Reported Event|Controls|15 subjects will be enrolled in the standard of care antibiotic group to serve as the controls. Controls will receive no experimental medications or treatments. The purpose of enrolling control patients was to serve as a reference group for intervention patients. Specifically cases and controls will be compared for changes in commonly collected hematologic parameters, creatinine, and CPK. Additionally, parameters collected during anesthesia will be compared. Controls will be matched to the intervention group by age (+/- 10 years), gender, and ethnicity.
1047691|NCT00701636|E1|Reported Event|Cases|The first 15 subjects enrolled will receive the intervention drug daptomycin as surgical antibiotic prophylaxis.
1047692|NCT00701558|B1|Baseline|Erlotinib + Gemcitabine|Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
1047693|NCT00701558|P1|Participant Flow|Erlotinib + Gemcitabine|Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
1047694|NCT00701558|O1|Outcome|Erlotinib + Gemcitabine|Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
1047695|NCT00701558|O1|Outcome|Erlotinib + Gemcitabine|Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
1047696|NCT00701558|O1|Outcome|Erlotinib + Gemcitabine|Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
1047697|NCT00701558|E1|Reported Event|Erlotinib + Gemcitabine|Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
1047698|NCT00701441|B3|Baseline|Total|Total of all reporting groups
1047699|NCT00701441|B2|Baseline|Obstructive Sleep Apnea|Participants wear continuous positive airway therapy
1047700|NCT00701441|B1|Baseline|Control|No diagnosis of Obstructive Sleep Apnea or treatment with continuous positive airwary therapy
1047701|NCT00701441|P2|Participant Flow|Obstructive Sleep Apnea|Participants wear continuous positive airway therapy
1047702|NCT00701441|P1|Participant Flow|Control|No diagnosis of Obstructive Sleep Apnea or treatment with continuous positive airwary therapy
1047703|NCT00701441|O3|Outcome|Obstructive Sleep Apnea Post Treatment|Participants with Obstructive Sleep Apnea after receiving positive airway pressure treatment for twelve weeks(Stain Density Units)
1048767|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
1047704|NCT00701441|O2|Outcome|Control|Participants with no diagnosis of obstructive sleep apnea and no treatment with continuous positive airway pressure(Stain Density Units)
1047705|NCT00701441|O1|Outcome|Obstructive Sleep Apnea-pre Treatment|Participants with Obstructive Sleep Apnea prior to receiving positive airway pressure treatment(Stain Density Units)
1047706|NCT00701441|O3|Outcome|Obstructive Sleep Apnea Post Treatment|Participants with Obstructive Sleep Apnea after receiving positive airway pressure treatment for twelve weeks(% dilation change from baseline)
1047707|NCT00701441|O2|Outcome|Control|Participants with no diagnosis of obstructive sleep apnea and no treatment with continuous positive airway pressure
1047708|NCT00701441|O1|Outcome|Obstructive Sleep Apnea-pre Treatment|Participants with Obstructive Sleep Apnea prior to receiving positive airway pressure treatment
1047709|NCT00701441|E2|Reported Event|Obstructive Sleep Apnea|Participants wear continuous positive airway therapy
1047710|NCT00701441|E1|Reported Event|Control|No diagnosis of Obstructive Sleep Apnea or treatment with continuous positive airwary therapy
1047711|NCT00701415|B3|Baseline|Total|Total of all reporting groups
1047712|NCT00701415|B2|Baseline|Fabrazyme 1.0 mg/kg|Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusion) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
1047713|NCT00701415|B1|Baseline|Fabrazyme 0.5 mg/kg|Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusion) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
1047714|NCT00701415|P2|Participant Flow|Fabrazyme 1.0 mg/kg|Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusions) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
1047715|NCT00701415|P1|Participant Flow|Fabrazyme 0.5 mg/kg|Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusions) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
1047716|NCT00701415|O2|Outcome|Fabrazyme 1.0 mg/kg|Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusions) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
1047717|NCT00701415|O1|Outcome|Fabrazyme 0.5 mg/kg|Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusions) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
1047718|NCT00701415|O2|Outcome|Fabrazyme 1.0 mg/kg|Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusions) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
1047719|NCT00701415|O1|Outcome|Fabrazyme 0.5 mg/kg|Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusions) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
1047720|NCT00701415|O2|Outcome|Fabrazyme 1.0 mg/kg|Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusions) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
1047721|NCT00701415|O1|Outcome|Fabrazyme 0.5 mg/kg|Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusions) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
1047722|NCT00701415|E2|Reported Event|Fabrazyme 1.0 mg/kg|Fabrazyme 1.0 mg/kg was administered every 4 weeks (up to 66 infusion) up to 260 weeks, the total infusion time was not less than 90 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
1047723|NCT00701415|E1|Reported Event|Fabrazyme 0.5 mg/kg|Fabrazyme 0.5 mg/kg was administered every 2 weeks (up to 131 infusion) up to 260 weeks, the total infusion time was not less than 45 minutes. In case of significant progression of Fabry disease, the dose was increased to 1.0 mg/kg every 2 weeks.
1047724|NCT00701389|B1|Baseline|All Enrolled Participants|All participants enrolled in the study
1047725|NCT00701389|P4|Participant Flow|Sequence 4: D→A→B→C|Participants receive the following: Period 1: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D), Period 2: single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treament A); Period 3: single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B); Period 4: single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C). Each dosing period is separated by a 5-day washout.
1047726|NCT00701389|P3|Participant Flow|Sequence 3: C→B→A→D|Participants receive the following: Period 1 :single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C), Period 2: single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B); Period 3: single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treatment A): Period 4: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D). Each dosing period is separated by a 5-day washout.
1047727|NCT00701389|P2|Participant Flow|Sequence 2: B→D→C→A|Participants receive the following: Period 1:single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B); Period 2: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D): Period 3: single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C); Period 4:single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treatment A). Each dosing period is separated by a 5-day washout.
1047728|NCT00701389|P1|Participant Flow|Sequence 1: A→C→D→B|Participants receive the following: Period 1: single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treatment A); Period 2: single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C); Period 3: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D); Period 4: single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B). Each dosing period is separated by a 5-day washout.
1047729|NCT00701389|O4|Outcome|Sumatriptan Placebo/Telcagepant Placebo|Participants who received single oral dose of generic placebo/telcagepant placebo in either period 1, 2, 3 or 4 of the crossover
1047730|NCT00701389|O3|Outcome|Sumatriptan Placebo/600 mg Telcagepant|Participants who received single oral dose of generic placebo/600 mg telcagepant in either Period 1, 2, 3, or 4 in the crossover
1047731|NCT00701389|O2|Outcome|100 mg Sumatriptan/Telcagepant Placebo|Participants who received single oral dose of 100 mg sumatriptan/telcagepant placebo in either Period 1, 2, 3, or 4 of the crossover
1047732|NCT00701389|O1|Outcome|100 mg Sumatriptan/600 mg Telcagepant|Participants who received single oral dose of 100 mg sumatriptan/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
1047733|NCT00701389|O4|Outcome|Sumatriptan Placebo/Telcagepant Placebo|Participants who received single oral dose of sumatriptan placebo/telcagepant placebo in either period 1, 2, 3 or 4 of the crossover
1047734|NCT00701389|O3|Outcome|Sumatriptan Placebo/600 mg Telcagepant|Participants who received single oral dose of sumatriptan placebo/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
1047735|NCT00701389|O2|Outcome|100 mg Sumatriptan/Telcagepant Placebo|Participants who received single oral dose of 100 mg sumatriptan/telcagepant placebo in either Period 1, 2, 3, or 4 of the crossover
1047736|NCT00701389|O1|Outcome|100 mg Sumatriptan/600 mg Telcagepant|Participants who received single oral dose of 100 mg sumatriptan/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
1047737|NCT00701389|O2|Outcome|Sumatriptan Placebo/Telcagepant Placebo|Participants who received single oral dose of sumatriptan placebo/telcagepant placebo in either Period 1, 2, 3, or 4 of the crossover
1047738|NCT00701389|O1|Outcome|Sumatriptan Placebo/600 mg Telcagepant|Participants who received single oral dose of sumatriptan placebo/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
1047739|NCT00701389|O2|Outcome|100 mg Sumatriptan/Telcagepant Placebo|Participants who received single oral dose of 100 mg sumatriptan/telcagepant placebo in either Period 1, 2, 3, or 4 of the crossover
1047740|NCT00701389|O1|Outcome|100 mg Sumatriptan/600 mg Telcagepant|Participants who received single oral dose of 100 mg sumatriptan/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
1047741|NCT00701389|E4|Reported Event|Sumatriptan Placebo/Telcagepant Placebo|Participants who received single oral dose of sumatriptan placebo/telcagepant placebo in either period 1, 2, 3 or 4 of the crossover
1047742|NCT00701389|E3|Reported Event|Sumatriptan Placebo/600 mg Telcagepant|Participants who received single oral dose of sumatriptan placebo/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
1047743|NCT00701389|E2|Reported Event|100 mg Sumatriptan/Telcagepant Placebo|Participants who received single oral dose of 100 mg sumatriptan/telcagepant placebo in either Period 1, 2, 3, or 4 of the crossover
1047744|NCT00701389|E1|Reported Event|100 mg Sumatriptan/600 mg Telcagepant|Participants who received single oral dose of 100 mg sumatriptan/600 mg telcagepant in either period 1, 2, 3 or 4 of the crossover
1047745|NCT00701363|B5|Baseline|Total|Total of all reporting groups
1047746|NCT00701363|B4|Baseline|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|Subjects with IGF-1 levels ≤50% of ULN at week 24 were assigned to group C. These subjects received 2 injections of Lanreotide Autogel 120 mg at 8-week intervals from week 24 up to week 48.
1047747|NCT00701363|B3|Baseline|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|Subjects with IGF-1 levels >50% to ≤100% of ULN at week 24 were assigned to group B. These subjects received 3 injections of Lanreotide Autogel 120 mg at 6-week intervals from week 24 up to week 48.
1047748|NCT00701363|B2|Baseline|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|Subjects with IGF-1 levels >100% to ≤130% of ULN at week 24 were assigned to group A. These subjects received 5 injections of Lanreotide Autogel 120 mg at 4-week intervals from week 24 up to week 48.
1047749|NCT00701363|B1|Baseline|Phase 1: Lanreotide Autogel 120 mg|Subjects in phase 1 received 5 injections of Lanreotide Autogel 120 mg subcutaneously (SC) at baseline and weeks 6, 12, 18 and 24. Baseline and week 24 injections were administered in the investigational centre, whereas the patient could receive weeks 6, 12 and 18 injections at home as part of the subject’s normal medical care, completing details of the injection in the diary cards provided.
1047750|NCT00701363|P4|Participant Flow|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|Subjects with IGF-1 levels ≤50% of ULN at week 24 were assigned to group C. These subjects received 2 injections of Lanreotide Autogel 120 mg at 8-week intervals from week 24 up to week 48.
1047751|NCT00701363|P3|Participant Flow|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|Subjects with IGF-1 levels >50% to ≤100% of ULN at week 24 were assigned to group B. These subjects received 3 injections of Lanreotide Autogel 120 mg at 6-week intervals from week 24 up to week 48.
1047752|NCT00701363|P2|Participant Flow|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|Subjects with IGF-1 levels >100% to ≤130% of ULN at week 24 were assigned to group A. These subjects received 5 injections of Lanreotide Autogel 120 mg at 4-week intervals from week 24 up to week 48.
1047753|NCT00701363|P1|Participant Flow|Phase 1: Lanreotide Autogel 120 mg|Subjects in phase 1 received 5 injections of Lanreotide Autogel 120 mg subcutaneously (SC) at baseline and weeks 6, 12, 18 and 24. Baseline and week 24 injections were administered in the investigational centre, whereas the patient could receive weeks 6, 12 and 18 injections at home as part of the subject’s normal medical care, completing details of the injection in the diary cards provided.
1047754|NCT00701363|O1|Outcome|Overall Study|
1047755|NCT00701363|O1|Outcome|Overall Study|Lanreotide Autogel 120 mg injections every 6 weeks, then depending on IGF-1 results at Week 24
1047756|NCT00701363|O5|Outcome|Overall Study|
1047757|NCT00701363|O4|Outcome|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|
1047758|NCT00701363|O3|Outcome|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|
1047759|NCT00701363|O2|Outcome|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|
1047760|NCT00701363|O1|Outcome|Phase 1 Only: Lanreotide Autogel 120 mg|
1047761|NCT00701363|O1|Outcome|Overall Study|
1047762|NCT00701363|O1|Outcome|Overall Study|
1047763|NCT00701363|O5|Outcome|Overall Study|
1047764|NCT00701363|O4|Outcome|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|
1047765|NCT00701363|O3|Outcome|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|
1047766|NCT00701363|O2|Outcome|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|
1047767|NCT00701363|O1|Outcome|Phase 1 Only: Lanreotide Autogel 120 mg|
1047768|NCT00701363|O5|Outcome|Overall Study|
1047769|NCT00701363|O4|Outcome|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|
1047770|NCT00701363|O3|Outcome|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|
1047773|NCT00701363|O4|Outcome|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|Subjects with IGF-1 levels ≤50% of ULN at week 24 were assigned to group C. These subjects received 2 injections of Lanreotide Autogel 120 mg at 8-week intervals from week 24 up to week 48.
1047774|NCT00701363|O3|Outcome|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|Subjects with IGF-1 levels >50% to ≤100% of ULN at week 24 were assigned to group B. These subjects received 3 injections of Lanreotide Autogel 120 mg at 6-week intervals from week 24 up to week 48.
1047775|NCT00701363|O2|Outcome|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|Subjects with IGF-1 levels >100% to ≤130% of ULN at week 24 were assigned to group A. These subjects received 5 injections of Lanreotide Autogel 120 mg at 4-week intervals from week 24 up to week 48.
1047776|NCT00701363|O1|Outcome|Phase 1 Only: Lanreotide Autogel 120 mg|Only 15 subjects participated only in phase 1 and did not move on to phase 2. The other entered in phase 2 according to IGF-1 level. Subjects in phase 1 received 5 injections of Lanreotide Autogel 120 mg subcutaneously (SC) at baseline and weeks 6, 12, 18 and 24. Baseline and week 24 injections were administered in the investigational centre, whereas the patient could receive weeks 6, 12 and 18 injections at home as part of the subject's normal medical care, completing details of the injection in the diary cards provided.
1047777|NCT00701363|O1|Outcome|Overall Study|
1047778|NCT00701363|O3|Outcome|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|
1047779|NCT00701363|O2|Outcome|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|
1047780|NCT00701363|O1|Outcome|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|
1047781|NCT00701363|O3|Outcome|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|
1047782|NCT00701363|O2|Outcome|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|
1047783|NCT00701363|O1|Outcome|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|
1047784|NCT00701363|O1|Outcome|Overall Study|
1047785|NCT00701363|O1|Outcome|Overall Study|
1047786|NCT00701363|O1|Outcome|Overall Study|
1047787|NCT00701363|O1|Outcome|Overall Study|
1047788|NCT00701363|E4|Reported Event|Phase 2 (Group C): Lanreotide Autogel 120 mg Every 8 Weeks|Subjects with IGF-1 levels ≤50% of ULN at week 24 were assigned to group C. These subjects received 2 injections of Lanreotide Autogel 120 mg at 8-week intervals from week 24 up to week 48.
1047789|NCT00701363|E3|Reported Event|Phase 2 (Group B): Lanreotide Autogel 120 mg Every 6 Weeks|Subjects with IGF-1 levels >50% to ≤100% of ULN at week 24 were assigned to group B. These subjects received 3 injections of Lanreotide Autogel 120 mg at 6-week intervals from week 24 up to week 48.
1047790|NCT00701363|E2|Reported Event|Phase 2 (Group A): Lanreotide Autogel 120 mg Every 4 Weeks|Subjects with IGF-1 levels >100% to ≤130% of ULN at week 24 were assigned to group A. These subjects received 5 injections of Lanreotide Autogel 120 mg at 4-week intervals from week 24 up to week 48.
1047791|NCT00701363|E1|Reported Event|Phase 1: Lanreotide Autogel 120 mg|Subjects in phase 1 received 5 injections of Lanreotide Autogel 120 mg subcutaneously (SC) at baseline and weeks 6, 12, 18 and 24. Baseline and week 24 injections were administered in the investigational centre, whereas the patient could receive weeks 6, 12 and 18 injections at home as part of the subject's normal medical care, completing details of the injection in the diary cards provided.
1047792|NCT00701311|B1|Baseline|CC-10004|CC-10004 administered 20mg po twice daily for up to 12 weeks.
1047793|NCT00701311|P1|Participant Flow|CC-10004|CC-10004 administered 20mg po twice daily for up to 12 weeks.
1047794|NCT00701311|O1|Outcome|CC-10004|CC-10004 administered 20mg po twice daily for up to 12 weeks.
1047795|NCT00701311|E1|Reported Event|Treatment Arm|Open label, one arm study.
1047796|NCT00701129|B1|Baseline|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
1047797|NCT00701129|P1|Participant Flow|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 milligrams per kilogram (mg/kg) intravenous (IV) infusion every other week (qow) (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was less than (<) 6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 milligrams per square meter (mg/m^2) (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
1047798|NCT00701129|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
1047813|NCT00701103|B6|Baseline|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
1047814|NCT00701103|B5|Baseline|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
1047815|NCT00701103|B4|Baseline|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
1047816|NCT00701103|B3|Baseline|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
1047799|NCT00701129|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
1047800|NCT00701129|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
1047801|NCT00701129|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
1047802|NCT00701129|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
1047803|NCT00701129|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
1047804|NCT00701129|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
1047805|NCT00701129|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
1047806|NCT00701129|E1|Reported Event|Alglucosidase Alfa|Alglucosidase alfa (Myozyme®) 20 mg/kg IV infusion qow (or optionally 20 mg/kg IV infusion every week [qw]) beginning from Day 0 to a minimum of 18 months or if the patient was <6 months of age at the time of enrollment, until the patient was 2 years of age, along with methotrexate 0.4 mg/kg subcutaneously for 3 consecutive days qow beginning from Day 0 to Week 6 (9 doses) and rituximab 375 mg/m^2 (or 12.5 mg/kg for patients with body surface area less than or equal to 0.5 m^2) IV infusion qw beginning from Day -1 to Week 4 (4 doses) as per local prescribing information. An additional 4-week cycle of rituximab (up to 4 additional doses) and 6-week cycle of methotrexate (up to 9 additional doses) may have been administered within the first 6 months of the study as per local prescribing information.
1047807|NCT00701103|B12|Baseline|Total|Total of all reporting groups
1047808|NCT00701103|B11|Baseline|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
1047809|NCT00701103|B10|Baseline|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
1047810|NCT00701103|B9|Baseline|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
1047811|NCT00701103|B8|Baseline|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
1047812|NCT00701103|B7|Baseline|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
1047817|NCT00701103|B2|Baseline|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
1047818|NCT00701103|B1|Baseline|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
1047819|NCT00701103|P11|Participant Flow|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion 1 time every 3 weeks (Q3W).
1047820|NCT00701103|P10|Participant Flow|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion 1 time every 2 weeks (Q2W).
1047821|NCT00701103|P9|Participant Flow|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
1047822|NCT00701103|P8|Participant Flow|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
1047823|NCT00701103|P7|Participant Flow|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
1047824|NCT00701103|P6|Participant Flow|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
1047825|NCT00701103|P5|Participant Flow|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
1047826|NCT00701103|P4|Participant Flow|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
1047827|NCT00701103|P3|Participant Flow|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
1047828|NCT00701103|P2|Participant Flow|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
1047829|NCT00701103|P1|Participant Flow|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) intravenous (IV) infusion 1 time every 1 week (Q1W).
1047830|NCT00701103|O11|Outcome|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
1047831|NCT00701103|O10|Outcome|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
1047832|NCT00701103|O9|Outcome|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
1047833|NCT00701103|O8|Outcome|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
1047834|NCT00701103|O7|Outcome|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
1047835|NCT00701103|O6|Outcome|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
1047836|NCT00701103|O5|Outcome|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
1047837|NCT00701103|O4|Outcome|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
1047838|NCT00701103|O3|Outcome|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
1047839|NCT00701103|O2|Outcome|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
1047840|NCT00701103|O1|Outcome|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
1047841|NCT00701103|O11|Outcome|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
1047842|NCT00701103|O10|Outcome|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
1047843|NCT00701103|O9|Outcome|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
1047844|NCT00701103|O8|Outcome|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
1047845|NCT00701103|O7|Outcome|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
1047846|NCT00701103|O6|Outcome|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
1047847|NCT00701103|O5|Outcome|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
1047848|NCT00701103|O4|Outcome|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
1047849|NCT00701103|O3|Outcome|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
1047850|NCT00701103|O2|Outcome|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
1047851|NCT00701103|O1|Outcome|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
1047852|NCT00701103|O7|Outcome|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
1047853|NCT00701103|O6|Outcome|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg IV infusion Q1W or Q2W.
1047854|NCT00701103|O5|Outcome|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg IV infusion Q1W.
1047855|NCT00701103|O4|Outcome|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg IV infusion Q1W.
1047856|NCT00701103|O3|Outcome|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
1047857|NCT00701103|O2|Outcome|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
1047858|NCT00701103|O1|Outcome|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
1047859|NCT00701103|O7|Outcome|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
1047860|NCT00701103|O6|Outcome|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg IV infusion Q1W or Q2W.
1047861|NCT00701103|O5|Outcome|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg IV infusion Q1W.
1047862|NCT00701103|O4|Outcome|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg IV infusion Q1W.
1047863|NCT00701103|O3|Outcome|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
1047864|NCT00701103|O2|Outcome|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
1047865|NCT00701103|O1|Outcome|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
1047866|NCT00701103|O11|Outcome|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
1047867|NCT00701103|O10|Outcome|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
1047868|NCT00701103|O9|Outcome|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
1047869|NCT00701103|O8|Outcome|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
1047870|NCT00701103|O7|Outcome|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
1047871|NCT00701103|O6|Outcome|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
1047872|NCT00701103|O5|Outcome|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
1047873|NCT00701103|O4|Outcome|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
1047874|NCT00701103|O3|Outcome|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
1047875|NCT00701103|O2|Outcome|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
1047876|NCT00701103|O1|Outcome|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
1047877|NCT00701103|O11|Outcome|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
1047878|NCT00701103|O10|Outcome|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
1047879|NCT00701103|O9|Outcome|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
1047880|NCT00701103|O8|Outcome|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
1047881|NCT00701103|O7|Outcome|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
1047882|NCT00701103|O6|Outcome|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
1047883|NCT00701103|O5|Outcome|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
1047884|NCT00701103|O4|Outcome|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
1047885|NCT00701103|O3|Outcome|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
1047886|NCT00701103|O2|Outcome|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
1047887|NCT00701103|O1|Outcome|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
1047888|NCT00701103|O11|Outcome|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
1047889|NCT00701103|O10|Outcome|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
1047890|NCT00701103|O9|Outcome|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
1047891|NCT00701103|O8|Outcome|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
1047892|NCT00701103|O7|Outcome|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
1047893|NCT00701103|O6|Outcome|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
1047894|NCT00701103|O5|Outcome|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
1047895|NCT00701103|O4|Outcome|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
1047896|NCT00701103|O3|Outcome|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
1047897|NCT00701103|O2|Outcome|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
1047898|NCT00701103|O1|Outcome|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
1047899|NCT00701103|O11|Outcome|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
1047900|NCT00701103|O10|Outcome|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
1047901|NCT00701103|O9|Outcome|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
1047902|NCT00701103|O8|Outcome|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
1047903|NCT00701103|O7|Outcome|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
1047904|NCT00701103|O6|Outcome|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
1047905|NCT00701103|O5|Outcome|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
1047906|NCT00701103|O4|Outcome|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
1047907|NCT00701103|O3|Outcome|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
1047908|NCT00701103|O2|Outcome|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
1047909|NCT00701103|O1|Outcome|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
1047910|NCT00701103|O11|Outcome|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
1047911|NCT00701103|O10|Outcome|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
1047912|NCT00701103|O9|Outcome|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
1047913|NCT00701103|O8|Outcome|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
1047914|NCT00701103|O7|Outcome|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
1047915|NCT00701103|O6|Outcome|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
1047916|NCT00701103|O5|Outcome|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
1047917|NCT00701103|O4|Outcome|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
1047918|NCT00701103|O3|Outcome|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
1047919|NCT00701103|O2|Outcome|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
1047920|NCT00701103|O1|Outcome|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
1047921|NCT00701103|E11|Reported Event|Dalotuzumab 30 mg/kg Q3W (20 mg/mL)|Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
1047922|NCT00701103|E10|Reported Event|Dalotuzumab 20 mg/kg Q2W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
1047923|NCT00701103|E9|Reported Event|Dalotuzumab 20 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q1W.
1047924|NCT00701103|E8|Reported Event|Dalotuzumab 20 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
1047925|NCT00701103|E7|Reported Event|Dalotuzumab 15 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 15 mg/kg (20 mg/mL) IV infusion Q1W.
1047926|NCT00701103|E6|Reported Event|Dalotuzumab 15 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
1047927|NCT00701103|E5|Reported Event|Dalotuzumab 10 mg/kg Q1W (20 mg/mL)|Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
1047928|NCT00701103|E4|Reported Event|Dalotuzumab 10 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
1047929|NCT00701103|E3|Reported Event|Dalotuzumab 5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
1047930|NCT00701103|E2|Reported Event|Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
1047931|NCT00701103|E1|Reported Event|Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)|Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
1047932|NCT00701090|B3|Baseline|Total|Total of all reporting groups
1047933|NCT00701090|B2|Baseline|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
1047934|NCT00701090|B1|Baseline|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
1047935|NCT00701090|P2|Participant Flow|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
1047936|NCT00701090|P1|Participant Flow|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
1047937|NCT00701090|O2|Outcome|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
1047938|NCT00701090|O1|Outcome|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
1047939|NCT00701090|O2|Outcome|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
1047940|NCT00701090|O1|Outcome|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
1047941|NCT00701090|O2|Outcome|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
1047942|NCT00701090|O1|Outcome|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
1047943|NCT00701090|O2|Outcome|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
1047944|NCT00701090|O1|Outcome|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
1047945|NCT00701090|O2|Outcome|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
1047946|NCT00701090|O1|Outcome|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
1047947|NCT00701090|O2|Outcome|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
1047948|NCT00701090|O1|Outcome|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
1047949|NCT00701090|E2|Reported Event|Glimepiride|The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
1047950|NCT00701090|E1|Reported Event|Sitagliptin|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
1047951|NCT00701064|B3|Baseline|Total|Total of all reporting groups
1047952|NCT00701064|B2|Baseline|Negative Ion Generator|"Negative Ion Generator (30 min/day)~Negative Ion Generator: Administered via Negative Ion Generatore"
1047953|NCT00701064|B1|Baseline|Bright Light Exposure|"Bright Light (30 min/day)~Bright Light Exposure: Administered via bright light box"
1047954|NCT00701064|P2|Participant Flow|Negative Ion Generator|"Negative Ion Generator (30 min/day)~Negative Ion Generator: Administered via Negative Ion Generatore"
1047955|NCT00701064|P1|Participant Flow|Bright Light Exposure|"Bright Light (30 min/day)~Bright Light Exposure: Administered via bright light box"
1047956|NCT00701064|O2|Outcome|Arm 2: Placebo Negative Ion Generator|"Negative Ion Generator (30 min/day)~Inactivated Negative Ion Generator: Administered via Negative Ion Generator"
1047957|NCT00701064|O1|Outcome|Arm 1: Bright Light|"Bright Light (30 min/day)~Bright Light Exposure: Administered via bright light box"
1047958|NCT00701064|E2|Reported Event|Arm 2: Negative Ion Generator|"Negative Ion Generator (30 min/day)~Negative Ion Generator: Administered via Negative Ion Generatore"
1047959|NCT00701064|E1|Reported Event|Arm 1: Bright Light Exposure|"Bright Light (30 min/day)~Bright Light Exposure: Administered via bright light box"
1047960|NCT00701051|B3|Baseline|Total|Total of all reporting groups
1047961|NCT00701051|B2|Baseline|Older Adults - Impaired Glucose Tolerance|Impaired Glucose Tolerance
1047962|NCT00701051|B1|Baseline|Older Adults - Normal Glucose Tolerance|Normal Glucose Tolerance
1047963|NCT00701051|P3|Participant Flow|Older Adults - Impaired Glucose Tolerance|Impaired Glucose Tolerance. Participants assigned to group after Period 1: Screening
1047964|NCT00701051|P2|Participant Flow|Older Adults - Normal Glucose Tolerance|Normal Glucose Tolerance. Participants assigned to group after Period 1: Screening
1047965|NCT00701051|P1|Participant Flow|Older Adults|
1047966|NCT00701051|O1|Outcome|Older Adults|Normal and Impaired Glucose Tolerance
1047967|NCT00701051|O1|Outcome|Older Adults|Normal and Impaired Glucose Tolerance
1047968|NCT00701051|O1|Outcome|Older Adults|Normal and Impaired Glucose Tolerance
1047969|NCT00701051|O2|Outcome|Older Adults - Impaired Glucose Tolerance|Impaired Glucose Tolerance
1047970|NCT00701051|O1|Outcome|Older Adults - Normal Glucose Tolerance|Normal Glucose Tolerance
1047971|NCT00701051|O2|Outcome|Older Adults - Impaired Glucose Tolerance|Impaired Glucose Tolerance
1047972|NCT00701051|O1|Outcome|Older Adults - Normal Glucose Tolerance|Normal Glucose Tolerance
1047973|NCT00701051|O1|Outcome|Older Adults|Normal and Impaired Glucose Tolerance
1047974|NCT00701051|O1|Outcome|Older Adults|Normal and Impaired Glucose Tolerance
1047975|NCT00701051|O2|Outcome|Older Adults - Impaired Glucose Tolerance|Impaired Glucose Tolerance
1047976|NCT00701051|O1|Outcome|Older Adults - Normal Glucose Tolerance|Normal Glucose Tolerance
1047977|NCT00701051|O2|Outcome|Older Adults - Impaired Glucose Tolerance|Impaired Glucose Tolerance
1047978|NCT00701051|O1|Outcome|Older Adults - Normal Glucose Tolerance|Normal Glucose Tolerance
1047979|NCT00701051|E1|Reported Event|Older Adults|Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm); thus, data are reported for the entire group of participants.
1047980|NCT00701038|B3|Baseline|Total|Total of all reporting groups
1047981|NCT00701038|B2|Baseline|Control|No auto adjusting bi-level positive airway pressure device given during hospital stay
1047982|NCT00701038|B1|Baseline|Device|Provided with an auto adjusting bi-level positive airway pressure device for 3 days in hospital
1047983|NCT00701038|P2|Participant Flow|Control|No auto adjusting bi-level positive airway pressure device given during hospital stay
1047984|NCT00701038|P1|Participant Flow|Device|Provided with an auto adjusting bi-level positive airway pressure device for 3 days in hospital
1047985|NCT00701038|O2|Outcome|Control|No auto adjusting bi-level positive airway pressure device given during hospital stay
1047986|NCT00701038|O1|Outcome|Device|Provided with an auto adjusting bi-level positive airway pressure device for 3 days in hospital
1047987|NCT00701038|E2|Reported Event|Control|No auto adjusting bi-level positive airway pressure device given during hospital stay
1047988|NCT00701038|E1|Reported Event|Device|Provided with an auto adjusting bi-level positive airway pressure device for 3 days in hospital
1047989|NCT00700999|B3|Baseline|Total|Total of all reporting groups
1047990|NCT00700999|B2|Baseline|Combat Exposed Controls|veterans returning from OEF/OIF with documented exposure to combat trauma who do not meet criteria for DSM-IV diagnosis of PTSD
1047991|NCT00700999|B1|Baseline|Treatment Group|Veterans returning from OEF/OIF with documented exposure to combat trauma who meet criteria for DSM-IV diagnosis of PTSD
1047992|NCT00700999|P2|Participant Flow|Combat Exposed Controls|Veterans returning from OEF/OIF with documented exposure to combat trauma who do not meet criteria for DSM-IV diagnosis of PTSD
1047993|NCT00700999|P1|Participant Flow|Treatment (Paroxetine) Group|Veterans returning from OEF/OIF with documented exposure to combat trauma who meet criteria for DSM-IV diagnosis of PTSD. Completed 12 weeks of treatment with paroxetine (20-40mg QD)
1048755|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
1047994|NCT00700999|O2|Outcome|Combat Exposed Control|Veterans returning from OEF/OIF with documented exposure to combat trauma who do not meet criteria for DSM-IV diagnosis of PTSD.
1047995|NCT00700999|O1|Outcome|Treatment (Paroxetine) Group|Veterans returning from OEF/OIF with documented exposure to combat trauma who meet criteria for DSM-IV diagnosis of PTSD
1047996|NCT00700999|E2|Reported Event|Combat Exposed Controls|Veterans returning from OEF/OIF with documented exposure to combat trauma who do not meet criteria for DSM-IV diagnosis of PTSD
1047997|NCT00700999|E1|Reported Event|Treatment (Paroxetine) Group|Veterans returning from OEF/OIF with documented exposure to combat trauma who meet criteria for DSM-IV diagnosis of PTSD
1047998|NCT00700973|B3|Baseline|Total|Total of all reporting groups
1047999|NCT00700973|B2|Baseline|Arm 2|"Interpersonal violence prevention intervention~Interpersonal Violence Prevention Intervention: This is a cognitive-behavioral approach incorporating cognitive restructuring and behavioral change."
1048000|NCT00700973|B1|Baseline|Arm 1|"Substance use disorder usual care~Usual care: Substance use disorder usual care"
1048001|NCT00700973|P2|Participant Flow|IPV-P|"Interpersonal violence prevention intervention~Interpersonal Violence Prevention Intervention: This is a cognitive-behavioral approach incorporating cognitive restructuring and behavioral change."
1048002|NCT00700973|P1|Participant Flow|Usual Care|"Substance use disorder usual care~Usual care: Substance use disorder usual care"
1048003|NCT00700973|O2|Outcome|Arm 2|"Interpersonal violence prevention intervention~Interpersonal Violence Prevention Intervention: This is a cognitive-behavioral approach incorporating cognitive restructuring and behavioral change."
1048004|NCT00700973|O1|Outcome|Arm 1|"Substance use disorder usual care~Usual care: Substance use disorder usual care"
1048005|NCT00700973|E2|Reported Event|Arm 2|"Interpersonal violence prevention intervention~Interpersonal Violence Prevention Intervention: This is a cognitive-behavioral approach incorporating cognitive restructuring and behavioral change."
1048006|NCT00700973|E1|Reported Event|Arm 1|"Substance use disorder usual care~Usual care: Substance use disorder usual care"
1048007|NCT00700817|B6|Baseline|Total|Total of all reporting groups
1048008|NCT00700817|B5|Baseline|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048009|NCT00700817|B4|Baseline|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048010|NCT00700817|B3|Baseline|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048011|NCT00700817|B2|Baseline|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048012|NCT00700817|B1|Baseline|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048013|NCT00700817|P5|Participant Flow|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048014|NCT00700817|P4|Participant Flow|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048015|NCT00700817|P3|Participant Flow|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048016|NCT00700817|P2|Participant Flow|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048017|NCT00700817|P1|Participant Flow|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048018|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048019|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048020|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048021|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048022|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048023|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048024|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048025|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048026|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048027|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048028|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048029|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048030|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048031|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048032|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048033|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048034|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048035|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048036|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048037|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048038|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048039|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048040|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048041|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048042|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1056697|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1048043|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048044|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048045|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048046|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048047|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048048|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048049|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048050|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048051|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048052|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048053|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048054|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048055|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048056|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048057|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048058|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048059|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048060|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048061|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048062|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048063|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048756|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
1048064|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048065|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048066|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048067|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048068|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048069|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048070|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048071|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048072|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048073|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048074|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048075|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048076|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048077|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048078|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048079|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048080|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048081|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048082|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048083|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048084|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048757|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
1048085|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048086|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048087|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048088|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048089|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048090|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048091|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048092|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048093|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048094|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048095|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048096|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048097|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048098|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048099|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048100|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048101|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048102|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048103|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048104|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048105|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048408|NCT00700752|P2|Participant Flow|Balafilcon A/Senofilcon A|balafilcon A silicone hydrogel contact lens worn first, senofilcon A silicone hydrogel contact lens worn second.
1048106|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048107|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048108|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048109|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048110|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048111|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048112|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048113|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048114|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048115|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048116|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048117|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048118|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048119|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048120|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048121|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048122|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048123|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048124|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048125|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048126|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1056698|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1048127|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048128|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048129|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048130|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048131|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048132|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048133|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048134|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048135|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048136|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048137|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048138|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048139|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048140|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048141|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048142|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048143|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048144|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048145|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048146|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048147|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1056699|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1048148|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048149|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048150|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048151|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048152|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048153|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048154|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048155|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048156|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048157|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048158|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048159|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048160|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048161|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048162|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048163|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048164|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048165|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048166|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048167|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048168|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048758|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
1048169|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048170|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048171|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048172|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048173|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048174|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048175|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048176|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048177|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048178|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048179|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048180|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048181|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048182|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048183|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048184|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048185|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048186|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048187|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048188|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048189|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048759|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
1048190|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048191|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048192|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048193|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048194|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048195|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048196|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048197|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048198|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048199|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048200|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048201|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048202|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048203|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048204|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048205|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048206|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048207|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048208|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048209|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048210|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048409|NCT00700752|P1|Participant Flow|Senofilcon A/Balafilcon A|senofilcon A silicone hydrogel contact lens worn first, balafilcon A silicone hydrogel contact lens worn second.
1048211|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048212|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048213|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048214|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048215|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048216|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048217|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048218|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048219|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048220|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048221|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048222|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048223|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048224|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048225|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048226|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048227|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048228|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048229|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048230|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048231|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1056700|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1048232|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048233|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048234|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048235|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048236|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048237|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048238|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048239|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048240|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048241|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048242|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048243|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048244|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048245|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048246|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048247|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048248|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048249|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048250|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048251|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048252|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1056701|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1048253|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048254|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048255|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048256|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048257|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048258|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048259|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048260|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048261|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048262|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048263|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048264|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048265|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048266|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048267|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048268|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048269|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048270|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048271|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048272|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048273|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048760|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
1048274|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048275|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048276|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048277|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048278|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048279|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048280|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048281|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048282|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048283|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048284|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048285|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048286|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048287|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048288|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048289|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048290|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048291|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048292|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048293|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048294|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048761|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
1048295|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048296|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048297|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048298|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048299|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048300|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048301|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048302|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048303|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048304|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048305|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048306|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048307|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048308|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048309|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048310|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048311|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048312|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048313|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048314|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048315|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048410|NCT00700752|O2|Outcome|Balafilcon A|silicone hydrogel contact lens worn daily with a 4-week replacement regimen
1048762|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
1048316|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048317|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048318|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048319|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048320|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048321|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048322|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048323|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048324|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048325|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048326|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048327|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048328|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048329|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048330|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048331|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048332|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048333|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048334|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048335|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048336|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1056702|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1048337|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048338|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048339|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048340|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048341|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048342|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048343|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048344|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048345|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048346|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048347|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048348|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048349|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048350|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048351|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048352|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048353|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048354|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048355|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048356|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048357|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1056703|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1048358|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048359|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048360|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048361|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048362|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048363|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048364|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048365|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048366|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048367|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048368|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048369|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048370|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048371|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048372|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048373|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048374|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048375|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048376|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048377|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048378|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048763|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
1048379|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048380|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048381|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048382|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048383|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048384|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048385|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048386|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048387|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048388|NCT00700817|O5|Outcome|Sita -> Sita -> Lira 1.8 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
1048389|NCT00700817|O4|Outcome|Sita -> Sita -> Lira 1.2 mg|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
1048390|NCT00700817|O3|Outcome|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048391|NCT00700817|O2|Outcome|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048392|NCT00700817|O1|Outcome|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048393|NCT00700817|E3|Reported Event|Sita -> Sita|Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
1048394|NCT00700817|E2|Reported Event|Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg|Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048395|NCT00700817|E1|Reported Event|Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg|Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
1048396|NCT00700804|B3|Baseline|Total|Total of all reporting groups
1048397|NCT00700804|B2|Baseline|Low Calcium Diet|Women consumed diets containing 600 milligrams of calcium daily
1048398|NCT00700804|B1|Baseline|High Calcium Diet|Women consumed diets containing 1500 milligrams of calcium daily
1048399|NCT00700804|P2|Participant Flow|Low Calcium Diet|Women consumed diets containing 600 milligrams of calcium daily
1048400|NCT00700804|P1|Participant Flow|High Calcium Diet|Women consumed diets containing 1500 milligrams of calcium daily
1048401|NCT00700804|O2|Outcome|Low Calcium Diet|Women consumed diets containing 600 milligrams of calcium daily
1048402|NCT00700804|O1|Outcome|High Calcium Diet|Women consumed diets containing 1500 milligrams of calcium daily
1048403|NCT00700804|O2|Outcome|Low Calcium Diet|Women consumed diets containing 600 milligrams of calcium daily
1048404|NCT00700804|O1|Outcome|High Calcium Diet|Women consumed diets containing 1500 milligrams of calcium daily
1048405|NCT00700804|E2|Reported Event|Low Calcium Diet|Women consumed diets containing 600 milligrams of calcium daily
1048406|NCT00700804|E1|Reported Event|High Calcium Diet|Women consumed diets containing 1500 milligrams of calcium daily
1048407|NCT00700752|B1|Baseline|Overall|Completed study population
1048411|NCT00700752|O1|Outcome|Senofilcon A|silicone hydrogel contact lens worn daily with a 2-week replacement regimen.
1048412|NCT00700752|E2|Reported Event|Balafilcon A/Senofilcon A|balafilcon A silicone hydrogel contact lens worn first, senofilcon A silicone hydrogel contact lens worn second.
1048413|NCT00700752|E1|Reported Event|Senofilcon A/Balafilcon A|senofilcon A silicone hydrogel contact lens worn first, balafilcon A silicone hydrogel contact lens worn second.
1048414|NCT00700739|B3|Baseline|Total|Total of all reporting groups
1048415|NCT00700739|B2|Baseline|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
1048416|NCT00700739|B1|Baseline|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
1048417|NCT00700739|P2|Participant Flow|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
1048418|NCT00700739|P1|Participant Flow|Cervical Total Disc Replacement|DISCOVER Artificial Cervical Disc
1048419|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
1048420|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
1048421|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
1048422|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
1048423|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
1048424|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
1048425|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
1048426|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
1048427|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
1048428|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
1048429|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
1048430|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
1048431|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
1048432|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
1048433|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
1048434|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
1048435|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
1048436|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
1048437|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
1048438|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
1048439|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
1048440|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER Artificial Cervical Disc
1048441|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
1048442|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER Artificial Cervical Disc
1048443|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
1048444|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER Artificial Cervical Disc
1048445|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
1048446|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER Artificial Cervical Disc
1048447|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
1048448|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
1048449|NCT00700739|O2|Outcome|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
1048450|NCT00700739|O1|Outcome|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
1048451|NCT00700739|E2|Reported Event|ACDF|Anterior Cervical Discectomy and Fusion (ACDF)
1048452|NCT00700739|E1|Reported Event|Cervical Total Disc Replacement|DISCOVER™ Artificial Cervical Disc
1048453|NCT00700713|B4|Baseline|Total|Total of all reporting groups
1048454|NCT00700713|B3|Baseline|Menactra-naïve Group|Participants had never received Menactra® vaccine.
1048455|NCT00700713|B2|Baseline|Two-Dose Menactra Group|Participants received two doses of Menactra® in Study MTA26
1048456|NCT00700713|B1|Baseline|One-Dose Menactra Group|Participants received one dose of Menactra® in Study MTA26.
1048457|NCT00700713|P3|Participant Flow|Menactra-naïve Group|Participants had never received Menactra® vaccine.
1048458|NCT00700713|P2|Participant Flow|Two-Dose Menactra Group|Participants received two doses of Menactra® in Study MTA26.
1048459|NCT00700713|P1|Participant Flow|One-Dose Menactra Group|Participants received one dose of Menactra® in Study MTA26.
1048460|NCT00700713|O3|Outcome|Menactra-naïve Group|Participants had never received Menactra® vaccine.
1048461|NCT00700713|O2|Outcome|Two-Dose Menactra Group|Participants received two doses of Menactra® in Study MTA26.
1048462|NCT00700713|O1|Outcome|One-Dose Menactra Group|Participants received one dose of Menactra® in Study MTA26.
1048463|NCT00700713|O3|Outcome|Menactra-naïve Group|Participants had never received Menactra® vaccine.
1048464|NCT00700713|O2|Outcome|Two-Dose Menactra Group|Participants received two doses of Menactra® in Study MTA26.
1048465|NCT00700713|O1|Outcome|One-Dose Menactra Group|Participants received one dose of Menactra® in Study MTA26.
1048466|NCT00700713|O3|Outcome|Menactra-naïve Group|Participants had never received Menactra® vaccine.
1048467|NCT00700713|O2|Outcome|Two-Dose Menactra Group|Participants received two doses of Menactra® in Study MTA26.
1048468|NCT00700713|O1|Outcome|One-Dose Menactra Group|Participants received one dose of Menactra® in Study MTA26.
1048469|NCT00700713|E3|Reported Event|Menactra-naïve Group|Participants had never received Menactra® vaccine.
1048470|NCT00700713|E2|Reported Event|Two-Dose Menactra Group|Participants received two doses of Menactra® in Study MTA26.
1048471|NCT00700713|E1|Reported Event|One-Dose Menactra Group|Participants received one dose of Menactra® in Study MTA26.
1048472|NCT00700635|B4|Baseline|Total|Total of all reporting groups
1048473|NCT00700635|B3|Baseline|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
1048474|NCT00700635|B2|Baseline|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
1048475|NCT00700635|B1|Baseline|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
1048476|NCT00700635|P3|Participant Flow|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
1048477|NCT00700635|P2|Participant Flow|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
1048478|NCT00700635|P1|Participant Flow|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
1048479|NCT00700635|O3|Outcome|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
1048480|NCT00700635|O2|Outcome|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
1048481|NCT00700635|O1|Outcome|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
1048482|NCT00700635|O3|Outcome|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
1048483|NCT00700635|O2|Outcome|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
1048484|NCT00700635|O1|Outcome|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
1048485|NCT00700635|O3|Outcome|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
1048486|NCT00700635|O2|Outcome|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
1048487|NCT00700635|O1|Outcome|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
1048488|NCT00700635|O3|Outcome|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
1048489|NCT00700635|O2|Outcome|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
1048490|NCT00700635|O1|Outcome|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
1048491|NCT00700635|O3|Outcome|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
1048492|NCT00700635|O2|Outcome|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
1048493|NCT00700635|O1|Outcome|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
1048494|NCT00700635|E3|Reported Event|Menactra® Group 3|Participants aged 6 to less than 11 years who received a single dose of vaccine
1048495|NCT00700635|E2|Reported Event|Menactra® Group 2|Participants aged 4 to less than 6 years who received 2 doses of vaccine
1048496|NCT00700635|E1|Reported Event|Menactra® Group 1|Participants aged 2 to less than 4 years who received 2 doses of vaccine
1048497|NCT00700622|B3|Baseline|Total|Total of all reporting groups
1048498|NCT00700622|B2|Baseline|Insulin Lispro + Insulin Glargine|Humalog (insulin lispro) in combination with Lantus (insulin glargine)
1048499|NCT00700622|B1|Baseline|TI + Insulin Glargine|Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine)
1048500|NCT00700622|P2|Participant Flow|Insulin Lispro + Insulin Glargine|Humalog (insulin lispro) in combination with Lantus (insulin glargine)
1048501|NCT00700622|P1|Participant Flow|TI + Insulin Glargine|Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine)
1048502|NCT00700622|O2|Outcome|Insulin Lispro + Insulin Glargine|Humalog (insulin lispro) in combination with Lantus (insulin glargine)
1048503|NCT00700622|O1|Outcome|TI + Insulin Glargine|Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine)
1048504|NCT00700622|E2|Reported Event|Insulin Lispro + Insulin Glargine|Humalog (insulin lispro) in combination with Lantus (insulin glargine)
1048505|NCT00700622|E1|Reported Event|TI + Insulin Glargine|Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine)
1048506|NCT00700570|B3|Baseline|Total|Total of all reporting groups
1048507|NCT00700570|B2|Baseline|Unresected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Unresectable participants with PR or SD, according to RECIST version 1.1, repeated neoadjuvant treatment until documented resectability or PD. Participants could be withdrawn at any point for unacceptable toxicity.
1048508|NCT00700570|B1|Baseline|Resected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Participants could be withdrawn at any point for unacceptable toxicity.
1048509|NCT00700570|P2|Participant Flow|Unresected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Unresectable participants with partial response (PR) or stable disease (SD), according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, repeated neoadjuvant treatment until documented resectability or progressive disease (PD). Participants could be withdrawn at any point for unacceptable toxicity.
1048546|NCT00700427|O1|Outcome|Atomoxetine|80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
1048588|NCT00700310|O4|Outcome|Perampanel 8 mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
1048589|NCT00700310|O3|Outcome|Perampanel 4mg|Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks)
1048764|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
1048510|NCT00700570|P1|Participant Flow|Resected|Participants with unresectable liver metastases secondary to colorectal cancer (CRC) were assigned to receive neoadjuvant treatment of intravenous (IV) bevacizumab with oral (PO) capecitabine and IV oxaliplatin (XELOX). Bevacizumab was given as 5 milligrams per kilogram (mg/kg) on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 milligrams per meter-squared (mg/m^2) on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Participants could be withdrawn at any point for unacceptable toxicity.
1048511|NCT00700570|O2|Outcome|Unresected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Unresectable participants with PR or SD, according to RECIST version 1.1, repeated neoadjuvant treatment until documented resectability or PD. Participants could be withdrawn at any point for unacceptable toxicity.
1048512|NCT00700570|O1|Outcome|Resected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Participants could be withdrawn at any point for unacceptable toxicity.
1048513|NCT00700570|O2|Outcome|Unresected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Unresectable participants with PR or SD, according to RECIST version 1.1, repeated neoadjuvant treatment until documented resectability or PD. Participants could be withdrawn at any point for unacceptable toxicity.
1048514|NCT00700570|O1|Outcome|Resected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Participants could be withdrawn at any point for unacceptable toxicity.
1048515|NCT00700570|O2|Outcome|Unresected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Unresectable participants with PR or SD, according to RECIST version 1.1, repeated neoadjuvant treatment until documented resectability or PD. Participants could be withdrawn at any point for unacceptable toxicity.
1048516|NCT00700570|O1|Outcome|Resected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Participants could be withdrawn at any point for unacceptable toxicity.
1048517|NCT00700570|O2|Outcome|Unresected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Unresectable participants with PR or SD, according to RECIST version 1.1, repeated neoadjuvant treatment until documented resectability or PD. Participants could be withdrawn at any point for unacceptable toxicity.
1048518|NCT00700570|O1|Outcome|Resected|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Participants could be withdrawn at any point for unacceptable toxicity.
1048585|NCT00700310|O3|Outcome|Perampanel 4mg|Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks)
1048586|NCT00700310|O2|Outcome|Perampanel 2mg|Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
1048587|NCT00700310|O1|Outcome|Placebo|Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
1048519|NCT00700570|O1|Outcome|All Participants|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Unresectable participants with PR or SD, according to RECIST version 1.1, repeated neoadjuvant treatment until documented resectability or PD. Participants could be withdrawn at any point for unacceptable toxicity.
1048520|NCT00700570|E1|Reported Event|All Participants|Participants with unresectable liver metastases secondary to CRC were assigned to receive neoadjuvant treatment of IV bevacizumab with XELOX. Bevacizumab was given as 5 mg/kg on Day 1 of each 14-day cycle during Cycles 1 to 5 and/or Cycles 8 to 12. During Cycles 1 to 12, IV oxaliplatin was given as 85 mg/m^2 on Day 1, and PO capecitabine as 1000 mg/m^2 twice daily on Days 1 to 5 and 8 to 12. Resectability was assessed at completion of Cycle 5. Resectable participants followed a new algorithm: complete Cycle 6 (XELOX), rest for 4 weeks, undergo surgery, rest for 4 weeks, complete adjuvant therapy during Cycles 7 (XELOX) and 8 to 12 (bevacizumab plus XELOX), and continue an additional 6 cycles with capecitabine and bevacizumab per Investigator discretion. Unresectable participants with PR or SD, according to RECIST version 1.1, repeated neoadjuvant treatment until documented resectability or PD. Participants could be withdrawn at any point for unacceptable toxicity.
1048521|NCT00700440|B1|Baseline|Cetuximab|400mg/m^2 intravenous infusion one week before radiotherapy, then 250mg/m^2 intravenous infusion weekly during radiotherapy
1048522|NCT00700440|P1|Participant Flow|Cetuximab|400mg/m^2 intravenous infusion one week before radiotherapy, then 250mg/m^2 intravenous infusion weekly during radiotherapy
1048523|NCT00700440|O1|Outcome|Cetuximab|400mg/m^2 intravenous infusion one week before radiotherapy, then 250mg/m^2 intravenous infusion weekly during radiotherapy
1048524|NCT00700440|E1|Reported Event|Cetuximab|400mg/m^2 intravenous infusion one week before radiotherapy, then 250mg/m^2 intravenous infusion weekly during radiotherapy
1048525|NCT00700427|B1|Baseline|Atomoxetine (40-100 mg)|40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment period (Study Period 2).
1048526|NCT00700427|P5|Participant Flow|Atomoxetine (Study Period 4)|Participants who received either atomoxetine or placebo and completed the last visit of Study Period 3 who were in countries where the adult ADHD indication for atomoxetine was not approved were allowed to participant in Study Period 4 (Open-label Extension). Participants received 40 mg/day atomoxetine orally for at least 7 days after which it was increased to 80-100 mg/day atomoxetine orally for up to 2.3 years.
1048527|NCT00700427|P4|Participant Flow|Placebo (Study Period 3B)|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
1048528|NCT00700427|P3|Participant Flow|Atomoxetine (Study Period 3B)|80-100 mg/day atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
1048529|NCT00700427|P2|Participant Flow|Atomoxetine (Study Period 3A)|40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during double-blind randomized withdrawal phase (Study Period 3).
1048530|NCT00700427|P1|Participant Flow|Atomoxetine (Study Period 2)|40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2).
1048531|NCT00700427|O2|Outcome|Placebo|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
1048532|NCT00700427|O1|Outcome|Atomoxetine|80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
1048533|NCT00700427|O2|Outcome|Placebo|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
1048534|NCT00700427|O1|Outcome|Atomoxetine|80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
1048535|NCT00700427|O2|Outcome|Placebo|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
1048536|NCT00700427|O1|Outcome|Atomoxetine|80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
1048537|NCT00700427|O2|Outcome|Placebo|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
1048538|NCT00700427|O1|Outcome|Atomoxetine|80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
1048539|NCT00700427|O2|Outcome|Placebo|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
1048540|NCT00700427|O1|Outcome|Atomoxetine|80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
1048541|NCT00700427|O2|Outcome|Placebo|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
1048542|NCT00700427|O1|Outcome|Atomoxetine|80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
1048543|NCT00700427|O2|Outcome|Placebo|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
1048544|NCT00700427|O1|Outcome|Atomoxetine|80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
1048545|NCT00700427|O2|Outcome|Placebo|Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).
1048547|NCT00700427|E4|Reported Event|Atomoxetine (Study Period 4; Open-Label Extension)|40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2), and 80-100 mg/day for 12 weeks during double-blind maintenance phase of Study Period 3 (Study Period 3A) and for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B), followed by a 2 year open label extension (Study Period 4). The open-label extension was optional and only offered to participants living in countries where atomoxetine for the adult ADHD indication had not been approved who had completed the Study Period 3B and were receiving benefit from the drug.
1048548|NCT00700427|E3|Reported Event|Placebo (Study Period 3B)|"40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2), and 80-100 mg/day for 12 weeks during double-blind maintenance phase of Study Period 3 (Study Period 3A).~Followed by Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B)."
1048549|NCT00700427|E2|Reported Event|Atomoxetine (Study Period 3B)|"40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2), and 80-100 mg/day for 12 weeks during double-blind maintenance phase of Study Period 3 (Study Period 3A).~Followed by 80-100 mg/day atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B)."
1048550|NCT00700427|E1|Reported Event|Atomoxetine (Study Periods 2 and 3A)|40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2), and 80-100 mg/day for 12 weeks during double-blind maintenance phase of Study Period 3 (Study Period 3A).
1048551|NCT00700401|B1|Baseline|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
1048552|NCT00700401|P1|Participant Flow|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
1048553|NCT00700401|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
1048554|NCT00700401|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
1048555|NCT00700401|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
1048556|NCT00700401|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
1048557|NCT00700401|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
1048558|NCT00700401|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
1048559|NCT00700401|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
1048560|NCT00700401|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
1048561|NCT00700401|E1|Reported Event|Peginterferon Alfa-2a + Ribavirin|Eligible participants receiving peginterferon alfa-2a (Pegasys) 180 microgram (µg) subcutaneously once a weekly with ribavirin (Copegus) 800 mg or 1000/1200 mg/day, according to the body weight (1000 mg [<75kg] or 1200 mg [>/=75 kg]) for 24 weeks were observed.
1048562|NCT00700375|B3|Baseline|Total|Total of all reporting groups
1048563|NCT00700375|B2|Baseline|Sodium Chloride Group|This group received an intravenous bolus injection of sodium chloride with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
1048564|NCT00700375|B1|Baseline|Sodium Bicarbonate Group|Randomly assigned to the sodium bicarbonate group or the sodium chloride group in a single-blinded fashion. This group received an intravenous bolus injection of sodium bicarbonate with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
1048565|NCT00700375|P2|Participant Flow|Sodium Chloride Group|This group received an intravenous bolus injection of sodium chloride with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
1048566|NCT00700375|P1|Participant Flow|Sodium Bicarbonate Group|Randomly assigned to the sodium bicarbonate group or the sodium chloride group in a single-blinded fashion. This group received an intravenous bolus injection of sodium bicarbonate with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
1048567|NCT00700375|O2|Outcome|Sodium Chloride Group|This group received an intravenous bolus injection of sodium chloride with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
1048568|NCT00700375|O1|Outcome|Sodium Bicarbonate Group|Randomly assigned to the sodium bicarbonate group or the sodium chloride group in a single-blinded fashion. This group received an intravenous bolus injection of sodium bicarbonate with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
1048569|NCT00700375|E2|Reported Event|Sodium Chloride Group|This group received an intravenous bolus injection of sodium chloride with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
1048570|NCT00700375|E1|Reported Event|Sodium Bicarbonate Group|Randomly assigned to the sodium bicarbonate group or the sodium chloride group in a single-blinded fashion. This group received an intravenous bolus injection of sodium bicarbonate with a dose of 0.5ml/kg as soon as possible before the administration of contrast medium. Afterward, the both groups were followed by an intravenous infusion of 1 ml/kg/hour sodium bicarbonate during and for 6 hours after the procedure.Nonionic, low-osmolality nonionic contrast media were used in all procedure and the volumes were left to the discretion of the operator. Emergent coronary procedures were almost performed by femoral approach. The decision to use an intra-aortic balloon pump, inotropic drugs, beta blockers, angiotensin-convertiong enzyme inhibitors, angiotensin receptor blockers or diuretics was based on international guidelines and left to the discretion of the attending physician.
1048571|NCT00700310|B5|Baseline|Total|Total of all reporting groups
1048572|NCT00700310|B4|Baseline|Perampanel 8 mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
1048573|NCT00700310|B3|Baseline|Perampanel 4mg|Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks)
1048574|NCT00700310|B2|Baseline|Perampanel 2mg|Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
1048575|NCT00700310|B1|Baseline|Placebo|Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
1048576|NCT00700310|P4|Participant Flow|Perampanel 8 mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
1048577|NCT00700310|P3|Participant Flow|Perampanel 4mg|Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks)
1048578|NCT00700310|P2|Participant Flow|Perampanel 2mg|Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
1048579|NCT00700310|P1|Participant Flow|Placebo|Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
1048580|NCT00700310|O4|Outcome|Perampanel 8 mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
1048581|NCT00700310|O3|Outcome|Perampanel 4mg|Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks)
1048582|NCT00700310|O2|Outcome|Perampanel 2mg|Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
1048583|NCT00700310|O1|Outcome|Placebo|Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
1048584|NCT00700310|O4|Outcome|Perampanel 8 mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
1048765|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
1048590|NCT00700310|O2|Outcome|Perampanel 2mg|Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
1048591|NCT00700310|O1|Outcome|Placebo|Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
1048592|NCT00700310|E4|Reported Event|Perampanel 8 mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
1048593|NCT00700310|E3|Reported Event|Perampanel 4mg|Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks)
1048594|NCT00700310|E2|Reported Event|Perampanel 2mg|Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
1048595|NCT00700310|E1|Reported Event|Placebo|Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
1048596|NCT00700271|B3|Baseline|Total|Total of all reporting groups
1048597|NCT00700271|B2|Baseline|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
1048598|NCT00700271|B1|Baseline|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
1048599|NCT00700271|P2|Participant Flow|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
1048600|NCT00700271|P1|Participant Flow|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
1048601|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
1048602|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
1048603|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
1048604|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
1048670|NCT00700102|P1|Participant Flow|Chemotherapy|"Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal~Chemotherapy: As prescribed"
1048671|NCT00700102|O2|Outcome|Chemotherapy + Bevacizumab|Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
1048672|NCT00700102|O1|Outcome|Chemotherapy|Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
1048673|NCT00700102|O2|Outcome|Chemotherapy + Bevacizumab|Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
1048605|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
1048606|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
1048607|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
1048608|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
1048609|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
1048610|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
1048611|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
1048612|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
1048613|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
1048614|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
1048674|NCT00700102|O1|Outcome|Chemotherapy|Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
1048675|NCT00700102|O2|Outcome|Chemotherapy + Bevacizumab|Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
1048615|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
1048616|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
1048617|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
1048618|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
1048619|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
1048620|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
1048621|NCT00700271|O2|Outcome|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
1048622|NCT00700271|O1|Outcome|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
1048623|NCT00700271|E2|Reported Event|Evening Intake|After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
1048624|NCT00700271|E1|Reported Event|Morning Intake|After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP >= 140 mmHg and/or msDBP >= 90 mmHg or msSBP >= 130 mmHg and/or msDBP >= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP < 140 mmHg and msDBP < 90 mmHg or msSBP < 130 mmHg and msDBP < 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
1048625|NCT00700180|B3|Baseline|Total|Total of all reporting groups
1048676|NCT00700102|O1|Outcome|Chemotherapy|Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
1056704|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1048626|NCT00700180|B2|Baseline|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
1048627|NCT00700180|B1|Baseline|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
1048628|NCT00700180|P2|Participant Flow|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
1048629|NCT00700180|P1|Participant Flow|Bevacizumab 7.5 Milligrams (mg) Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg per kilogram (mg/kg) intravenously (IV) on Day 1; either carboplatin at a dose required to achieve an area under the concentration-time curve (AUC) of 6 mg per milliliter (mg/mL) IV and paclitaxel 200 mg per square meter (mg/m^2) IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
1048630|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
1048631|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
1048632|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
1048633|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
1048634|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
1048677|NCT00700102|O2|Outcome|Chemotherapy + Bevacizumab|Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
1048678|NCT00700102|O1|Outcome|Chemotherapy|Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
1048679|NCT00700102|O2|Outcome|Chemotherapy + Bevacizumab|Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
1048635|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
1048636|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
1048637|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
1048638|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
1048639|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
1048640|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
1048641|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
1048642|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
1048643|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
1048680|NCT00700102|O1|Outcome|Chemotherapy|Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
1048681|NCT00700102|O2|Outcome|Chemotherapy + Bevacizumab|Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
1048682|NCT00700102|O1|Outcome|Chemotherapy|Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
1048766|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
1048644|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
1048645|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
1048646|NCT00700180|O2|Outcome|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
1048647|NCT00700180|O1|Outcome|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
1048648|NCT00700180|E2|Reported Event|Bevacizumab 15 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 15 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 15 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
1048649|NCT00700180|E1|Reported Event|Bevacizumab 7.5 mg Plus Chemotherapy|"Cycles 1-6 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; either carboplatin at a dose required to achieve an AUC of 6 mg/mL IV and paclitaxel 200 mg/m^2 IV on Day 1, or carboplatin at AUC 5 mg/mL IV on Day 1 and gemcitabine 1200 mg/m^2 IV on Days 1 and 8. The choice of chemotherapy doublet, either carboplatin/paclitaxel or carboplatin/gemcitabine, was left to the discretion of the investigator. The cycle was repeated until disease progression or for a maximum of 6 cycles.~Cycle 7 and beyond (3-week cycles): If the first 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1. This cycle was repeated every 3 weeks until disease progression."
1048650|NCT00700141|B1|Baseline|TachoSil® Application|Patients with application of at least one fleece of TachoSil® during thyroid surgery
1048651|NCT00700141|P1|Participant Flow|TachoSil® Application|Patients with application of at least one fleece of TachoSil® during thyroid surgery
1048652|NCT00700141|O1|Outcome|TachoSil® Application|Patients with application of at least one fleece of TachoSil® during thyroid surgery
1048653|NCT00700141|O1|Outcome|TachoSil® Application|Patients with application of at least one fleece of TachoSil® during thyroid surgery
1048654|NCT00700141|E1|Reported Event|TachoSil® Application|Patients with application of at least one fleece of TachoSil® during thyroid surgery
1048655|NCT00700115|B3|Baseline|Total|Total of all reporting groups
1048656|NCT00700115|B2|Baseline|Standard HAART|Pre-study standard HAART regimen
1048657|NCT00700115|B1|Baseline|Kaletra + Isentress|switched to Kaletra + Isentress
1048658|NCT00700115|P2|Participant Flow|Standard HAART|Pre-study standard HAART regimen
1048659|NCT00700115|P1|Participant Flow|Kaletra + Isentress|Switched to Kaletra + Isentress
1048660|NCT00700115|O2|Outcome|Standard HAART|Pre-study standard HAART regimen
1048661|NCT00700115|O1|Outcome|Kaletra + Isentress|switched to Kaletra + Isentress
1048662|NCT00700115|O2|Outcome|Standard HAART|Pre-study standard HAART regimen
1048663|NCT00700115|O1|Outcome|Kaletra + Isentress|switched to Kaletra + Isentress
1048664|NCT00700115|E2|Reported Event|Standard HAART|Pre-study standard HAART regimen
1048665|NCT00700115|E1|Reported Event|Kaletra + Isentress|switched to Kaletra + Isentress
1048666|NCT00700102|B3|Baseline|Total|Total of all reporting groups
1048667|NCT00700102|B2|Baseline|Chemotherapy + Bevacizumab|"Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal~Chemotherapy: As prescribed~Bevacizumab: Bevacizumab, 5 mg/kg intravenously (IV) on days 1 and 14 of each 4 week cycle, or 7.5 mg/kg IV on days 1 and 22 of each 6 week cycle."
1048668|NCT00700102|B1|Baseline|Chemotherapy|"Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal~Chemotherapy: As prescribed"
1048669|NCT00700102|P2|Participant Flow|Chemotherapy + Bevacizumab|"Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal~Chemotherapy: As prescribed~Bevacizumab: Bevacizumab, 5 mg/kg intravenously (IV) on days 1 and 14 of each 4 week cycle, or 7.5 mg/kg IV on days 1 and 22 of each 6 week cycle."
1048683|NCT00700102|E2|Reported Event|Chemotherapy + Bevacizumab|Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
1048684|NCT00700102|E1|Reported Event|Chemotherapy|Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
1048685|NCT00700063|B9|Baseline|Total|Total of all reporting groups
1048686|NCT00700063|B8|Baseline|8. Vehicle Gel|Three days treatment, day 1, 2, 3
1048687|NCT00700063|B7|Baseline|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
1048688|NCT00700063|B6|Baseline|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
1048689|NCT00700063|B5|Baseline|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
1048690|NCT00700063|B4|Baseline|4. Vehicle Gel|Two days treatment, day 1, 2
1048691|NCT00700063|B3|Baseline|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
1048692|NCT00700063|B2|Baseline|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
1048693|NCT00700063|B1|Baseline|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
1048694|NCT00700063|P8|Participant Flow|8. Vehicle Gel|Three days treatment, day 1, 2, 3
1048695|NCT00700063|P7|Participant Flow|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
1048696|NCT00700063|P6|Participant Flow|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
1048697|NCT00700063|P5|Participant Flow|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
1048698|NCT00700063|P4|Participant Flow|4. Vehicle Gel|Two days treatment, day 1, 2
1048699|NCT00700063|P3|Participant Flow|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
1048700|NCT00700063|P2|Participant Flow|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
1048701|NCT00700063|P1|Participant Flow|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
1048702|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
1048703|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
1048704|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
1048705|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
1048706|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
1048707|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
1048708|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
1048709|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
1048710|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
1048711|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
1048712|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
1048713|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
1048714|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
1048715|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
1048716|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
1048717|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
1048718|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
1048719|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
1048720|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
1048721|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
1048722|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
1048723|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
1048724|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
1048725|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
1048726|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
1048727|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
1048728|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
1048729|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
1048730|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
1048731|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
1048732|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
1048733|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
1048734|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
1048735|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
1048736|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
1048737|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
1048738|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
1048739|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
1048740|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
1048741|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
1048742|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
1048743|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
1048744|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
1048745|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
1048746|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
1048747|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
1048748|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
1048749|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
1048750|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
1048751|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
1048768|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
1048769|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
1048770|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
1048771|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
1048772|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
1048773|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
1048774|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
1048775|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
1048776|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
1048777|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
1048778|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
1048779|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
1048780|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
1048781|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
1048782|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
1048783|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
1048784|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
1048785|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
1048786|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
1048787|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
1048788|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
1048789|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
1048790|NCT00700063|O8|Outcome|8. Vehicle Gel|Three days treatment, day 1, 2, 3
1048791|NCT00700063|O7|Outcome|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
1048792|NCT00700063|O6|Outcome|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
1048793|NCT00700063|O5|Outcome|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
1048794|NCT00700063|O4|Outcome|4. Vehicle Gel|Two days treatment, day 1, 2
1048795|NCT00700063|O3|Outcome|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
1048796|NCT00700063|O2|Outcome|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
1048797|NCT00700063|O1|Outcome|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
1048798|NCT00700063|E8|Reported Event|8. Vehicle Gel|Three days treatment, day 1, 2, 3
1048799|NCT00700063|E7|Reported Event|7. PEP005 Topical Gel 0.015%|Three days treatment, day 1, 2, 3
1048800|NCT00700063|E6|Reported Event|6. PEP005 Topical Gel 0.01%|Three days treatment, day 1, 2, 3
1048801|NCT00700063|E5|Reported Event|5. PEP005 Topical Gel 0.005%|Three days treatment, day 1, 2, 3
1048802|NCT00700063|E4|Reported Event|4. Vehicle Gel|Two days treatment, day 1, 2
1048803|NCT00700063|E3|Reported Event|3. PEP005 Topical Gel 0.015%|Two days treatment day 1, 2
1048804|NCT00700063|E2|Reported Event|2. PEP005 Topical Gel 0.01%|Two days treatment, day 1, 2
1048805|NCT00700063|E1|Reported Event|1. PEP005 Topical Gel 0.005%|Two days treatment day 1, 2
1048806|NCT00700011|B3|Baseline|Total|Total of all reporting groups
1048807|NCT00700011|B2|Baseline|5 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
1048808|NCT00700011|B1|Baseline|10 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
1048809|NCT00700011|P2|Participant Flow|5 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
1048810|NCT00700011|P1|Participant Flow|10 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
1048811|NCT00700011|O2|Outcome|5 mg/m2 Group|Patients were treated with Clofarabine 5 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
1048812|NCT00700011|O1|Outcome|10 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
1048813|NCT00700011|O2|Outcome|5 mg/m2 Group|Patients were treated with Clofarabine 5 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
1048814|NCT00700011|O1|Outcome|10 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
1056705|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1051290|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
1048815|NCT00700011|O2|Outcome|5 mg/m2 Group|Patients were treated with Clofarabine 5 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
1048816|NCT00700011|O1|Outcome|10 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
1048817|NCT00700011|O2|Outcome|5 mg/m2 Group|Patients were treated with Clofarabine 5 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
1048818|NCT00700011|O1|Outcome|10 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
1048819|NCT00700011|E2|Reported Event|5 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
1048820|NCT00700011|E1|Reported Event|10 mg/m2 Group|Patients were treated with Clofarabine 10 mg/m2 daily x 5 days per cycle. Cycles were intended on being every 28 days but this was flexible due to the bone marrow neding to recover from each cycle before strting the next one. Neulasta was given on day 5 of each cycle. Patients were treated until disease progression, or intolerable toxicities.
1048821|NCT00699998|B5|Baseline|Total|Total of all reporting groups
1048822|NCT00699998|B4|Baseline|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
1048823|NCT00699998|B3|Baseline|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
1048824|NCT00699998|B2|Baseline|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
1048825|NCT00699998|B1|Baseline|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel : 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
1048826|NCT00699998|P4|Participant Flow|Clopidogrel: 75 Years of Age or Older|"Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older.~Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.~Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study."
1048827|NCT00699998|P3|Participant Flow|Clopidogrel: <75 Years of Age|"Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age.~Commercially-available Aspirin : Low-dose aspirin, oral, as prescribed by physician through end of study~Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study"
1048828|NCT00699998|P2|Participant Flow|Prasugrel: 75 Years of Age or Older|"Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older.~Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.~Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study."
1048829|NCT00699998|P1|Participant Flow|Prasugrel: <75 Years of Age|"Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age.~Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.~Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study."
1048830|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|"Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older.~Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.~Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study."
1048831|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|"Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age.~Commercially-available Aspirin : Low-dose aspirin, oral, as prescribed by physician through end of study~Clopidogrel : 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study"
1048894|NCT00699842|P2|Participant Flow|Lenalidomide (20mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
1057117|NCT00675792|O1|Outcome|Sugammadex|4 mg/kg sugammadex
1048832|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|"Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older.~Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.~Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg orally, once daily as maintenance dose through end of study."
1048833|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|"Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age.~Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study.~Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study."
1048834|NCT00699998|O2|Outcome|Clopidogrel|Clopidogrel and Low-Dose Commercially-available Aspirin in participants. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
1048835|NCT00699998|O1|Outcome|Prasugrel|Prasugrel and Low-dose Commercially-available Aspirin in participants. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight and age), oral, once daily as maintenance dose through end of study.
1048836|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
1048837|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
1048838|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
1048839|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
1048840|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
1048841|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
1048842|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
1048843|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
1048844|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
1048845|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
1048846|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
1048847|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
1048947|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048848|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
1048849|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
1048850|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
1048851|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
1048852|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
1048853|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
1048854|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
1048855|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
1048856|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
1048857|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
1048858|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
1048859|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
1048860|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
1048861|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
1048862|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
1048863|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
1057118|NCT00675792|O2|Outcome|Neostigmine|50 µg/kg neostigmine
1048864|NCT00699998|O4|Outcome|Clopidogrel: 75 Years of Age or Older|Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
1048865|NCT00699998|O3|Outcome|Clopidogrel: <75 Years of Age|Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
1048866|NCT00699998|O2|Outcome|Prasugrel: 75 Years of Age or Older|Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study.
1048867|NCT00699998|O1|Outcome|Prasugrel: <75 Years of Age|Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study.
1048868|NCT00699998|E2|Reported Event|Clopidogrel|Clopidogrel and Low-Dose Commercially-available Aspirin in participants. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study.
1048869|NCT00699998|E1|Reported Event|Prasugrel|Prasugrel and Low-dose Commercially-available Aspirin in participants. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight and age), oral, once daily as maintenance dose through end of study.
1048870|NCT00699972|B4|Baseline|Total|Total of all reporting groups
1048871|NCT00699972|B3|Baseline|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
1048872|NCT00699972|B2|Baseline|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
1048873|NCT00699972|B1|Baseline|Placebo|6 placebo tablets received daily during both Titration and Maintenance Periods.
1048874|NCT00699972|P3|Participant Flow|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
1048875|NCT00699972|P2|Participant Flow|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
1048876|NCT00699972|P1|Participant Flow|Placebo|6 placebo tablets received daily during both Titration and Maintenance Periods.
1048877|NCT00699972|O3|Outcome|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
1048878|NCT00699972|O2|Outcome|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
1048879|NCT00699972|O1|Outcome|Placebo|6 placebo tablets received daily during both Titration and Maintenance Periods.
1048880|NCT00699972|O3|Outcome|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
1048881|NCT00699972|O2|Outcome|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
1048882|NCT00699972|O1|Outcome|Placebo|6 placebo tablets received daily during both Titration and Maintenance Periods.
1048883|NCT00699972|O3|Outcome|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
1048884|NCT00699972|O2|Outcome|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
1048885|NCT00699972|O1|Outcome|Placebo|6 placebo tablets received daily during both Titration and Maintenance Periods.
1048886|NCT00699972|E3|Reported Event|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
1048887|NCT00699972|E2|Reported Event|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
1048888|NCT00699972|E1|Reported Event|Placebo|6 placebo tablets received daily during both Titration and Maintenance Periods.
1048889|NCT00699842|B4|Baseline|Total|Total of all reporting groups
1048890|NCT00699842|B3|Baseline|Lenalidomide (25mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
1048891|NCT00699842|B2|Baseline|Lenalidomide (20mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
1048892|NCT00699842|B1|Baseline|Lenalidomide (15mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
1048893|NCT00699842|P3|Participant Flow|Lenalidomide (25mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
1048944|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048895|NCT00699842|P1|Participant Flow|Lenalidomide (15mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
1048896|NCT00699842|O3|Outcome|Lenalidomide (25mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
1048897|NCT00699842|O2|Outcome|Lenalidomide (20mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
1048898|NCT00699842|O1|Outcome|Lenalidomide (15mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
1048899|NCT00699842|O3|Outcome|Lenalidomide (25mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
1048900|NCT00699842|O2|Outcome|Lenalidomide (20mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
1048901|NCT00699842|O1|Outcome|Lenalidomide (15mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
1048902|NCT00699842|E3|Reported Event|Lenalidomide (25mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
1048903|NCT00699842|E2|Reported Event|Lenalidomide (20mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
1048904|NCT00699842|E1|Reported Event|Lenalidomide (15mg)|"Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.~Lenalidomide: Dose Level Lenalidomide Schedule~15mg/day for d1-21 out of 28 days~20mg/day for d1-21 out of 28 days~25mg/day for d1-21 out of 28 days"
1048905|NCT00699816|B3|Baseline|Total|Total of all reporting groups
1048906|NCT00699816|B2|Baseline|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
1048907|NCT00699816|B1|Baseline|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
1048908|NCT00699816|P2|Participant Flow|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
1048909|NCT00699816|P1|Participant Flow|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
1048910|NCT00699816|O2|Outcome|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
1048911|NCT00699816|O1|Outcome|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
1048912|NCT00699816|O2|Outcome|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
1048913|NCT00699816|O1|Outcome|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
1048914|NCT00699816|O2|Outcome|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
1048945|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048946|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048915|NCT00699816|O1|Outcome|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
1048916|NCT00699816|O2|Outcome|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
1048917|NCT00699816|O1|Outcome|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
1048918|NCT00699816|O2|Outcome|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
1048919|NCT00699816|O1|Outcome|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
1048920|NCT00699816|O2|Outcome|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
1048921|NCT00699816|O1|Outcome|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
1048922|NCT00699816|E2|Reported Event|Control Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
1048923|NCT00699816|E1|Reported Event|Immunotherapy Group|Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
1048924|NCT00699751|B3|Baseline|Total|Total of all reporting groups
1048925|NCT00699751|B2|Baseline|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048926|NCT00699751|B1|Baseline|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048927|NCT00699751|P2|Participant Flow|Placebo|Participants received BSoC plus isotonic saline for 6 IV administrations separated by 4 weeks intervals in double-blind phase; Participants received radium223 50 kBq/kg body weight for 6 intravenous administrations separated by 4 weeks intervals after unblinding to the end of study.
1048928|NCT00699751|P1|Participant Flow|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received BSoC plus radium223 50 kBq/kg body weight for 6 IV administrations separated by 4 weeks intervals.
1048929|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048930|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048931|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048932|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048933|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048934|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048935|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048936|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048937|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048938|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048939|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048940|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048941|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048942|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048943|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1057119|NCT00675792|O1|Outcome|Sugammadex|4 mg/kg sugammadex
1048948|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048949|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048950|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048951|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048952|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048953|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048954|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048955|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048956|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048957|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048958|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048959|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048960|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048961|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048962|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048963|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048964|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048965|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048966|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048967|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048968|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048969|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048970|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048971|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048972|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048973|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048974|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048975|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048976|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048977|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048978|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048979|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048980|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048981|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048982|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048983|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048984|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048985|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048986|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048987|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048988|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048989|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048990|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048991|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048992|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048993|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048994|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048995|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048996|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048997|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1048998|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1048999|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1049000|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1049001|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1049002|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1049003|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1049004|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1049005|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1049006|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1049007|NCT00699751|O2|Outcome|Placebo|Isotonic saline for 6 IV administrations separated by 4 weeks intervals plus BSoC.
1049008|NCT00699751|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus BSoC.
1049009|NCT00699751|E3|Reported Event|Placebo Randomized, Then Switched to Radium-223 Dichloride|Participants received BSoC plus isotonic saline for 6 IV administrations separated by 4 weeks intervals in double-blind phase; Participants received radium223 50 kBq/kg body weight for 6 intravenous administrations separated by 4 weeks intervals after unblinding to the end of study.
1049010|NCT00699751|E2|Reported Event|Placebo|Participants received BSoC plus isotonic saline for 6 IV administrations separated by 4 weeks intervals in double-blind phase.
1049011|NCT00699751|E1|Reported Event|Radium-223 Dichloride (Xofigo, BAY88-8223)|Subjects received BSoC plus radium-223 50 kBq/kg body weight for 6 IV administrations separated by 4 weeks intervals.
1049012|NCT00699699|B1|Baseline|Spiriva® Respimat® 2 Puffs Once Daily at the Same Time|
1049013|NCT00699699|P1|Participant Flow|Spiriva® Respimat® 2 Puffs Once Daily at the Same Time|
1049014|NCT00699699|O1|Outcome|Spiriva® Respimat® 2 Puffs Once Daily at the Same Time|
1049015|NCT00699699|O1|Outcome|Spiriva® Respimat® 2 Puffs Once Daily at the Same Time|
1049016|NCT00699699|O1|Outcome|Spiriva® Respimat® 2 Puffs Once Daily at the Same Time|
1049017|NCT00699699|O1|Outcome|Spiriva® Respimat® 2 Puffs Once Daily at the Same Time|
1049018|NCT00699699|E1|Reported Event|Spiriva® Respimat® 2 Puffs Once Daily at the Same Time|
1049019|NCT00699660|B3|Baseline|Total|Total of all reporting groups
1049020|NCT00699660|B2|Baseline|Arm 2|"Usual PTSD interview, without CAPS or WHODAS~Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID"
1049021|NCT00699660|B1|Baseline|Arm 1|"PTSD interview using CAPS and WHODAS~Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview"
1049022|NCT00699660|P2|Participant Flow|Arm 2|"Usual PTSD interview, without CAPS or WHODAS~Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID"
1049023|NCT00699660|P1|Participant Flow|Arm 1|"PTSD interview using CAPS and WHODAS~Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview"
1049024|NCT00699660|O2|Outcome|Arm 2|"Usual PTSD interview, without CAPS or WHODAS~Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID"
1049025|NCT00699660|O1|Outcome|Arm 1|"PTSD interview using CAPS and WHODAS~Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview"
1049026|NCT00699660|O2|Outcome|Arm 2|"Usual PTSD interview, without CAPS or WHODAS~Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID"
1049027|NCT00699660|O1|Outcome|Arm 1|"PTSD interview using CAPS and WHODAS~Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview"
1049028|NCT00699660|O2|Outcome|Arm 2|"Usual PTSD interview, without CAPS or WHODAS~Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID"
1049029|NCT00699660|O1|Outcome|Arm 1|"PTSD interview using CAPS and WHODAS~Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview"
1049030|NCT00699660|O2|Outcome|Arm 2|"Usual PTSD interview, without CAPS or WHODAS~Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID"
1049031|NCT00699660|O1|Outcome|Arm 1|"PTSD interview using CAPS and WHODAS~Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview"
1057120|NCT00675792|O2|Outcome|Neostigmine|50 µg/kg neostigmine
1049032|NCT00699660|E2|Reported Event|Arm 2|"Usual PTSD interview, without CAPS or WHODAS~Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID"
1049033|NCT00699660|E1|Reported Event|Arm 1|"PTSD interview using CAPS and WHODAS~Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview"
1049034|NCT00699608|B1|Baseline|Entire Study Population|
1049035|NCT00699608|P6|Participant Flow|Placebo First, Zopiclone Second, Eszopiclone Third|Placebo during first intervention period, 7.5 mg zopiclone during second intervention period (after 4-14 day washout period), 3 mg eszopiclone during third intervention period (after 4-14 day washout period)
1049036|NCT00699608|P5|Participant Flow|Placebo First, Eszopiclone Second, Zopiclone Third|Placebo during first intervention period, 3 mg eszopiclone during second intervention period (after 4-14 day washout period), 7.5 mg zopiclone during third intervention period (after 4-14 day washout period)
1049037|NCT00699608|P4|Participant Flow|Zopiclone First, Placebo Second, Eszopiclone Third|7.5 mg zopiclone during first intervention period, placebo during second intervention period (after 4-14 day washout period), 3 mg eszopiclone during third intervention period (after 4-14 day washout period)
1049038|NCT00699608|P3|Participant Flow|Zopiclone First, Eszopiclone Second, Placebo Third|7.5 mg zopiclone during first intervention period, 3 mg eszopiclone during second intervention period (after 4-14 day washout period), placebo during third intervention period (after 4-14 day washout period)
1049039|NCT00699608|P2|Participant Flow|Eszopiclone First, Placebo Second, Zopiclone Third|3 mg eszopiclone during first intervention period, placebo during second intervention period (after 4-14 day washout period), 7.5 mg zopiclone during third intervention period (after 4-14 day washout period)
1049040|NCT00699608|P1|Participant Flow|Eszopiclone First, Zopiclone Second, Placebo Third|3 mg eszopiclone during first intervention period, 7.5 mg zopiclone during second intervention period (after 4-14 day washout period), placebo during third intervention period (after 4-14 day washout period)
1049041|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
1049042|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
1049043|NCT00699608|O1|Outcome|Placebo|Placebo
1049044|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
1049045|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
1049046|NCT00699608|O1|Outcome|Placebo|Placebo
1049047|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
1049048|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
1049049|NCT00699608|O1|Outcome|Placebo|Placebo
1049050|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
1049051|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
1049052|NCT00699608|O1|Outcome|Placebo|Placebo
1049053|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
1049054|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
1049055|NCT00699608|O1|Outcome|Placebo|Placebo
1049056|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
1049057|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
1049058|NCT00699608|O1|Outcome|Placebo|Placebo
1049059|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
1049060|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
1049061|NCT00699608|O1|Outcome|Placebo|Placebo
1049062|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
1049063|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
1049064|NCT00699608|O1|Outcome|Placebo|Placebo
1049065|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
1049066|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
1049067|NCT00699608|O1|Outcome|Placebo|Placebo
1049068|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
1049069|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
1049070|NCT00699608|O1|Outcome|Placebo|Placebo
1049071|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
1049072|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
1049073|NCT00699608|O1|Outcome|Placebo|Placebo
1049074|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
1049075|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
1049076|NCT00699608|O1|Outcome|Placebo|Placebo
1049077|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
1049078|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
1049079|NCT00699608|O1|Outcome|Placebo|Placebo
1049080|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
1049081|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
1049082|NCT00699608|O1|Outcome|Placebo|Placebo
1049083|NCT00699608|O3|Outcome|Zopiclone|7.5 mg Zopiclone
1049084|NCT00699608|O2|Outcome|Eszopiclone|3 mg Eszopiclone
1049085|NCT00699608|O1|Outcome|Placebo|Placebo
1049086|NCT00699608|E3|Reported Event|Zopiclone|7.5 mg Zopiclone
1049087|NCT00699608|E2|Reported Event|Eszopiclone|3 mg Eszopiclone
1049088|NCT00699608|E1|Reported Event|Placebo|Placebo
1049089|NCT00699582|B4|Baseline|Total|Total of all reporting groups
1049090|NCT00699582|B3|Baseline|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
1049091|NCT00699582|B2|Baseline|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
1049092|NCT00699582|B1|Baseline|Placebo|
1049093|NCT00699582|P3|Participant Flow|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
1049094|NCT00699582|P2|Participant Flow|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
1049095|NCT00699582|P1|Participant Flow|Placebo|
1049096|NCT00699582|O3|Outcome|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
1049097|NCT00699582|O2|Outcome|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
1049098|NCT00699582|O1|Outcome|Placebo|
1049099|NCT00699582|O3|Outcome|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
1049100|NCT00699582|O2|Outcome|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
1049101|NCT00699582|O1|Outcome|Placebo|
1049102|NCT00699582|O3|Outcome|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
1049103|NCT00699582|O2|Outcome|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
1049104|NCT00699582|O1|Outcome|Placebo|
1049105|NCT00699582|E3|Reported Event|Perampanel 12mg|Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
1049106|NCT00699582|E2|Reported Event|Perampanel 8mg|Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
1049107|NCT00699582|E1|Reported Event|Placebo|
1049108|NCT00699491|B7|Baseline|Total|Total of all reporting groups
1049109|NCT00699491|B6|Baseline|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.~15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22.~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
1049110|NCT00699491|B5|Baseline|Dose Level -2B|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~5 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
1049111|NCT00699491|B4|Baseline|Dose Level -2A|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~4 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
1049112|NCT00699491|B3|Baseline|Dose Level -2|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
1049113|NCT00699491|B2|Baseline|Dose Level -1|"20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
1049114|NCT00699491|B1|Baseline|Dose Level 1|"25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
1049115|NCT00699491|P6|Participant Flow|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.~15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22.~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
1049116|NCT00699491|P5|Participant Flow|Dose Level -2B|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~5 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
1049117|NCT00699491|P4|Participant Flow|Dose Level -2A|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~4 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
1049118|NCT00699491|P3|Participant Flow|Dose Level -2|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
1049119|NCT00699491|P2|Participant Flow|Dose Level -1|"20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
1049120|NCT00699491|P1|Participant Flow|Dose Level 1|"25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
1049121|NCT00699491|O1|Outcome|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.~15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
1049122|NCT00699491|O1|Outcome|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.~15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
1049123|NCT00699491|O1|Outcome|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.~15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
1049124|NCT00699491|O1|Outcome|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.~15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
1049125|NCT00699491|O1|Outcome|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.~15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
1049126|NCT00699491|O1|Outcome|Phase II|"Phase II patients receive the recommended phase II dose determined in the phase I portion.~15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.~4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
1049127|NCT00699491|O5|Outcome|Dose Level -2B|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~5 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
1049128|NCT00699491|O4|Outcome|Dose Level -2A|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~4 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
1049256|NCT00699192|P1|Participant Flow|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
1049129|NCT00699491|O3|Outcome|Dose Level -2|"15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
1049130|NCT00699491|O2|Outcome|Dose Level -1|"20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22~Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
1049131|NCT00699491|O1|Outcome|Dose Level 1|"25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22~3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
1049132|NCT00699491|E6|Reported Event|Phase II|laboratory biomarker analysis: Correlative studies
1049133|NCT00699491|E5|Reported Event|Dose Level -2B|Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1049134|NCT00699491|E4|Reported Event|Dose Level -2A|Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1049135|NCT00699491|E3|Reported Event|Dose Level -2|Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1049136|NCT00699491|E2|Reported Event|Dose Level -1|Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1049137|NCT00699491|E1|Reported Event|Dose Level 1|Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1049138|NCT00699413|B3|Baseline|Total|Total of all reporting groups
1049139|NCT00699413|B2|Baseline|Control Arm|nutrition education plus inactive supplement
1049140|NCT00699413|B1|Baseline|Intervention Arm|nutrition education plus active supplement
1049141|NCT00699413|P2|Participant Flow|Control Arm|nutrition education plus inactive supplement
1049142|NCT00699413|P1|Participant Flow|Intervention Arm|nutrition education plus active supplement
1049143|NCT00699413|O2|Outcome|Control Arm|nutrition education plus inactive supplement
1049144|NCT00699413|O1|Outcome|Intervention Arm|nutrition education plus active supplement
1049145|NCT00699413|E2|Reported Event|Control Arm|nutrition education plus inactive supplement
1049146|NCT00699413|E1|Reported Event|Intervention Arm|nutrition education plus active supplement
1049147|NCT00699400|B4|Baseline|Total|Total of all reporting groups
1049148|NCT00699400|B3|Baseline|Pre-Freeze Discontinuations|Participants who enrolled in the study but withdrew before oocyte retrieval or for whom oocyte retrieval failed (had no oocytes to freeze).
1049149|NCT00699400|B2|Baseline|Vitrification|Subjects that participated in one or more vitrification cycles
1049150|NCT00699400|B1|Baseline|Slow Freeze|Subjects that participated in one or more slow-freeze cycles
1049151|NCT00699400|P6|Participant Flow|Pre-freeze Discontinuations|Participants who enrolled in the study but withdrew before oocyte retrieval or for whom oocyte retrieval failed (had no oocytes to freeze).
1049152|NCT00699400|P5|Participant Flow|Both (Slow Freeze and Vitrification)|Participants who underwent both slow freezing and vitrification cycles (one cycle of each freezing technique).
1049153|NCT00699400|P4|Participant Flow|Vitrification (Two Cycles)|Subjects who participated in two freezing cycles of the Registry only using the vitrification technique (i.e. cryopreservation using high initial concentrations of cryoprotectant and ultra rapid cooling to solidify the cell without the formation of ice)
1049154|NCT00699400|P3|Participant Flow|Vitrification (One Cycle)|Subjects who participated in one freezing cycle of the Registry only using the vitrification technique (i.e. cryopreservation using high initial concentrations of cryoprotectant and ultra rapid cooling to solidify the cell without the formation of ice)
1049155|NCT00699400|P2|Participant Flow|Slow Freeze (Two Cycles)|Subjects who participated in two freezing cycles of the Registry only using the slow freeze technique (i.e. freezing that occurs at a slow rate to minimize ice formation)
1049156|NCT00699400|P1|Participant Flow|Slow Freeze (One Cycle)|Subjects who participated in one freezing cycle of the Registry only using the slow freeze technique (i.e. freezing that occurs at a slow rate to minimize ice formation)
1049157|NCT00699400|O3|Outcome|All Participants|
1049158|NCT00699400|O2|Outcome|Vitrification|
1049159|NCT00699400|O1|Outcome|Slow Freezing|
1049160|NCT00699400|O3|Outcome|All Participants|
1049161|NCT00699400|O2|Outcome|Vitrification|
1049162|NCT00699400|O1|Outcome|Slow Freezing|
1049163|NCT00699400|O3|Outcome|All Participants|
1049164|NCT00699400|O2|Outcome|Vitrification|
1049165|NCT00699400|O1|Outcome|Slow Freezing|
1049166|NCT00699400|O3|Outcome|All Participants|
1049167|NCT00699400|O2|Outcome|Vitrification|
1049168|NCT00699400|O1|Outcome|Slow Freezing|
1049169|NCT00699400|O3|Outcome|All Participants|
1049170|NCT00699400|O2|Outcome|Vitrification|
1049171|NCT00699400|O1|Outcome|Slow Freezing|
1049172|NCT00699400|O3|Outcome|All Participants|
1049173|NCT00699400|O2|Outcome|Vitrification|
1049174|NCT00699400|O1|Outcome|Slow Freezing|
1049175|NCT00699400|O3|Outcome|All Participants|
1049176|NCT00699400|O2|Outcome|Vitrification|
1049177|NCT00699400|O1|Outcome|Slow Freezing|
1049178|NCT00699400|O3|Outcome|All Participants|
1049179|NCT00699400|O2|Outcome|Vitrification|
1049180|NCT00699400|O1|Outcome|Slow Freezing|
1049181|NCT00699400|O3|Outcome|All Participants|
1049182|NCT00699400|O2|Outcome|Vitrification|
1049183|NCT00699400|O1|Outcome|Slow Freezing|
1049184|NCT00699400|E3|Reported Event|All Participants|
1049185|NCT00699400|E2|Reported Event|Vitrification|
1049186|NCT00699400|E1|Reported Event|Slow Freezing|
1049187|NCT00699374|B3|Baseline|Total|Total of all reporting groups
1049188|NCT00699374|B2|Baseline|Sorafenib|Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
1049257|NCT00699192|O3|Outcome|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
1049189|NCT00699374|B1|Baseline|Sunitinib|Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
1049190|NCT00699374|P2|Participant Flow|Sorafenib|Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
1049191|NCT00699374|P1|Participant Flow|Sunitinib|Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
1049192|NCT00699374|O2|Outcome|Sorafenib|Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
1049193|NCT00699374|O1|Outcome|Sunitinib|Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
1049194|NCT00699374|O2|Outcome|Sorafenib|Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
1049195|NCT00699374|O1|Outcome|Sunitinib|Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
1049196|NCT00699374|O2|Outcome|Sorafenib|Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
1049197|NCT00699374|O1|Outcome|Sunitinib|Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
1049198|NCT00699374|O2|Outcome|Sorafenib|Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
1049199|NCT00699374|O1|Outcome|Sunitinib|Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
1049200|NCT00699374|E2|Reported Event|Sorafenib|Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
1049201|NCT00699374|E1|Reported Event|Sunitinib|Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
1049202|NCT00699348|B1|Baseline|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
1049203|NCT00699348|P1|Participant Flow|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period [Week -4 to Week 0]) intravenous methoxy polyethylene glycolepoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 microgram (mcg) every 4 weeks for 24 weeks.
1049204|NCT00699348|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
1049205|NCT00699348|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
1049206|NCT00699348|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
1049207|NCT00699348|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
1049208|NCT00699348|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
1049209|NCT00699348|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
1049210|NCT00699348|E1|Reported Event|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
1049211|NCT00699335|B1|Baseline|Matrifen®|All patients enrolled
1049212|NCT00699335|P1|Participant Flow|Matrifen®|All patients enrolled
1049213|NCT00699335|O1|Outcome|Matrifen®|All patients with valid values ('as observed')
1049214|NCT00699335|O1|Outcome|Matrifen®|All patients with valid values ('as observed')
1049215|NCT00699335|O1|Outcome|Matrifen®|All patients with valid values at first and last visit
1049216|NCT00699335|O1|Outcome|Matrifen®|All patients with valid values at first and last visit
1049217|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
1049218|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
1049219|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
1049220|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
1049221|NCT00699335|O1|Outcome|Matrifen®|All patients with valid values ('as observed')
1049222|NCT00699335|O1|Outcome|Matrifen®|All patients with valid values ('as observed')
1049223|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
1049224|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
1049225|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
1049226|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
1049227|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
1049228|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
1049229|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
1049230|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
1049231|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
1049232|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
1049233|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
1049234|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
1049235|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
1049236|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
1049237|NCT00699335|O2|Outcome|Matrifen® / Final Visit|All patients with valid values at first and last visit
1049238|NCT00699335|O1|Outcome|Matrifen® / Initial Visit|All patients with valid values at first and last visit
1049239|NCT00699335|O1|Outcome|Matrifen®|All patients with valid values ('as observed')
1049240|NCT00699335|O1|Outcome|Matrifen®|All patients with valid values at first and last visit
1049241|NCT00699335|E1|Reported Event|Matrifen®|Patients included and treated with at least one application of Matrifen®
1049242|NCT00699283|B3|Baseline|Total Title|
1049243|NCT00699283|B2|Baseline|Brivaracetam (BRV) 100 mg|100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study).
1049244|NCT00699283|B1|Baseline|Brivaracetam (BRV) 50 mg|50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study).
1049245|NCT00699283|P2|Participant Flow|Brivaracetam (BRV) 100 mg|100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study).
1049246|NCT00699283|P1|Participant Flow|Brivaracetam (BRV) 50 mg|50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study).
1049247|NCT00699283|O1|Outcome|Efficacy Set (Brivaracetam 50 mg Treated Subjects)|"50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study).~The Efficacy Analysis Set (EFF) consisted of all randomized subjects with at least 1 intake of study medication who also entered into the Baseline antiepileptic drug (AED) Tapering Phase (during the Evaluation Period) and started with the withdrawal of Baseline AEDs."
1049248|NCT00699283|E2|Reported Event|Brivaracetam (BRV) 100 mg|100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study).
1049249|NCT00699283|E1|Reported Event|Brivaracetam (BRV) 50 mg|50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study).
1049250|NCT00699192|B4|Baseline|Total|Total of all reporting groups
1049251|NCT00699192|B3|Baseline|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
1049252|NCT00699192|B2|Baseline|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
1049253|NCT00699192|B1|Baseline|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
1049254|NCT00699192|P3|Participant Flow|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
1049255|NCT00699192|P2|Participant Flow|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
1049258|NCT00699192|O2|Outcome|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
1049259|NCT00699192|O1|Outcome|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
1049260|NCT00699192|O3|Outcome|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
1049261|NCT00699192|O2|Outcome|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
1049262|NCT00699192|O1|Outcome|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
1049263|NCT00699192|O3|Outcome|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
1049264|NCT00699192|O2|Outcome|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
1049265|NCT00699192|O1|Outcome|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
1049266|NCT00699192|O3|Outcome|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
1049267|NCT00699192|O2|Outcome|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
1049268|NCT00699192|O1|Outcome|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
1049269|NCT00699192|O3|Outcome|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
1049270|NCT00699192|O2|Outcome|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
1049271|NCT00699192|O1|Outcome|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
1049272|NCT00699192|E3|Reported Event|Amlodipine 5 mg|1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
1049273|NCT00699192|E2|Reported Event|Amlodipine/Valsartan 5/40 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
1049274|NCT00699192|E1|Reported Event|Amlodipine/Valsartan 5/80 mg|1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
1049275|NCT00699153|B3|Baseline|Total|Total of all reporting groups
1049276|NCT00699153|B2|Baseline|Vehicle|Vehicle of Ophthalmic Loteprednol Etabonate
1049277|NCT00699153|B1|Baseline|Loteprednol Etabonate|Loteprednol Etabonate Ophthalmic Ointment 0.5%
1049278|NCT00699153|P2|Participant Flow|Vehicle|Vehicle of Ophthalmic Loteprednol Etabonate
1049279|NCT00699153|P1|Participant Flow|Loteprednol Etabonate|Loteprednol Etabonate Ophthalmic Ointment 0.5%
1049280|NCT00699153|O2|Outcome|Vehicle|Vehicle of Ophthalmic Loteprednol Etabonate
1049281|NCT00699153|O1|Outcome|Loteprednol Etabonate|Loteprednol Etabonate Ophthalmic Ointment 0.5%
1049282|NCT00699153|O2|Outcome|Vehicle|Vehicle of Ophthalmic Loteprednol Etabonate
1049283|NCT00699153|O1|Outcome|Loteprednol Etabonate|Loteprednol Etabonate Ophthalmic Ointment 0.5%
1049284|NCT00699153|O2|Outcome|Vehicle|Vehicle of Ophthalmic Loteprednol Etabonate
1049285|NCT00699153|O1|Outcome|Loteprednol Etabonate|Loteprednol Etabonate Ophthalmic Ointment 0.5%
1049286|NCT00699153|O2|Outcome|Vehicle|Vehicle of Ophthalmic Loteprednol Etabonate
1049287|NCT00699153|O1|Outcome|Loteprednol Etabonate|Loteprednol Etabonate Ophthalmic Ointment 0.5%
1049288|NCT00699153|E2|Reported Event|Vehicle|Vehicle of Ophthalmic Loteprednol Etabonate
1049289|NCT00699153|E1|Reported Event|Loteprednol Etabonate|Loteprednol Etabonate Ophthalmic Ointment 0.5%
1049290|NCT00699140|B1|Baseline|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses."
1049291|NCT00699140|P1|Participant Flow|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses"
1049292|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses"
1049293|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I Grifols|"Open label, non-randomized treatment group with IGIV3I Grifols~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses.~IGIV3I Grifols: Immune Globulin Intravenous (Human)"
1049294|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I Grifols|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses."
1049295|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols. IGIV3I Grifols: Immune Globulin Intravenous (Human). All adverse events (AEs) are tabulated and summarized. Incidence, severity, and causal relationship of the AEs to IGIV3I Grifols are presented by system organ class after medical coding according to the version 15.0 of MedDRA.~The frequency of patients and infusions associated with at least one AE are estimated as the primary safety endpoint."
1049296|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses."
1049297|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses."
1049298|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses."
1049299|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses."
1049602|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
1049300|NCT00699140|O1|Outcome|1 Treatment Group With IGIV3I|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)~Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses."
1049301|NCT00699140|E1|Reported Event|1 Treatment Group With IGIV3I Grifols|"Open label, non-randomized treatment group with IGIV3I Grifols~IGIV3I Grifols: Immune Globulin Intravenous (Human)"
1049302|NCT00698932|B3|Baseline|Total|Total of all reporting groups
1049303|NCT00698932|B2|Baseline|Placebo|Placebo tablet, once daily( OD) for 24 weeks
1049304|NCT00698932|B1|Baseline|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
1049305|NCT00698932|P2|Participant Flow|Placebo|Placebo tablet, once daily( OD) for 24 weeks
1049306|NCT00698932|P1|Participant Flow|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
1049307|NCT00698932|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
1049308|NCT00698932|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
1049309|NCT00698932|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
1049310|NCT00698932|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
1049311|NCT00698932|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
1049312|NCT00698932|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
1049313|NCT00698932|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
1049314|NCT00698932|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
1049315|NCT00698932|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
1049316|NCT00698932|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
1049317|NCT00698932|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
1049318|NCT00698932|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
1049319|NCT00698932|E2|Reported Event|Placebo|Placebo tablet, once daily( OD) for 24 weeks
1049320|NCT00698932|E1|Reported Event|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
1049321|NCT00698841|B1|Baseline|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
1049322|NCT00698841|P1|Participant Flow|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
1049323|NCT00698841|O1|Outcome|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
1049324|NCT00698841|O1|Outcome|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
1049325|NCT00698841|O1|Outcome|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
1049326|NCT00698841|O1|Outcome|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
1049327|NCT00698841|O1|Outcome|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
1049328|NCT00698841|O1|Outcome|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
1049329|NCT00698841|O1|Outcome|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
1049330|NCT00698841|O1|Outcome|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
1049331|NCT00698841|E1|Reported Event|Cetuximab|Cetuximab given by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
1049332|NCT00698815|B4|Baseline|Total|Total of all reporting groups
1049333|NCT00698815|B3|Baseline|Arm III (Pemetrexed and Sunitinib)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
1049334|NCT00698815|B2|Baseline|Arm II (Sunitinib)|Patients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
1049335|NCT00698815|B1|Baseline|Arm I (Pemetrexed)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
1049336|NCT00698815|P3|Participant Flow|Arm III (Pemetrexed and Sunitinib)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
1049337|NCT00698815|P2|Participant Flow|Arm II (Sunitinib)|Patients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
1049338|NCT00698815|P1|Participant Flow|Arm I (Pemetrexed)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
1049339|NCT00698815|O3|Outcome|Arm III (Pemetrexed and Sunitinib)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
1049340|NCT00698815|O2|Outcome|Arm II (Sunitinib)|Patients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
1049341|NCT00698815|O1|Outcome|Arm I (Pemetrexed)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
1049342|NCT00698815|O3|Outcome|Arm III (Pemetrexed and Sunitinib)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
1049343|NCT00698815|O2|Outcome|Arm II (Sunitinib)|Patients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
1049344|NCT00698815|O1|Outcome|Arm I (Pemetrexed)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
1049345|NCT00698815|O3|Outcome|Arm III (Pemetrexed and Sunitinib)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
1049346|NCT00698815|O2|Outcome|Arm II (Sunitinib)|Patients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
1049347|NCT00698815|O1|Outcome|Arm I (Pemetrexed)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
1049348|NCT00698815|O3|Outcome|Arm III (Pemetrexed and Sunitinib)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
1049349|NCT00698815|O2|Outcome|Arm II (Sunitinib)|Patients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
1049350|NCT00698815|O1|Outcome|Arm I (Pemetrexed)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
1049351|NCT00698815|E3|Reported Event|Arm III (Pemetrexed and Sunitinib)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
1049352|NCT00698815|E2|Reported Event|Arm II (Sunitinib)|Patients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
1049353|NCT00698815|E1|Reported Event|Arm I (Pemetrexed)|Patients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
1049354|NCT00698685|B1|Baseline|Preparative Regimen of Pentostatin and Alemtuzumab|"Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic [related or unrelated] Hematopoietic SCT.~Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper."
1049355|NCT00698685|P1|Participant Flow|Preparative Regimen of Pentostatin and Alemtuzumab|"Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic [related or unrelated] Hematopoietic SCT.~Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper."
1049356|NCT00698685|O1|Outcome|Preparative Regimen of Pentostatin and Alemtuzumab|"Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic [related or unrelated] Hematopoietic SCT.~Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper."
1049384|NCT00698646|E3|Reported Event|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
1049603|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
1049357|NCT00698685|O1|Outcome|Preparative Regimen of Pentostatin and Alemtuzumab|"Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic [related or unrelated] Hematopoietic SCT.~Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper."
1049358|NCT00698685|E1|Reported Event|Preparative Regimen of Pentostatin and Alemtuzumab|"Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic [related or unrelated] Hematopoietic SCT.~Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper."
1049359|NCT00698646|B4|Baseline|Total|Total of all reporting groups
1049360|NCT00698646|B3|Baseline|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
1049361|NCT00698646|B2|Baseline|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
1049362|NCT00698646|B1|Baseline|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
1049363|NCT00698646|P3|Participant Flow|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
1049364|NCT00698646|P2|Participant Flow|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
1049365|NCT00698646|P1|Participant Flow|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
1049366|NCT00698646|O3|Outcome|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
1049367|NCT00698646|O2|Outcome|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
1049368|NCT00698646|O1|Outcome|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
1049369|NCT00698646|O3|Outcome|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
1049370|NCT00698646|O2|Outcome|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
1049371|NCT00698646|O1|Outcome|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
1049372|NCT00698646|O3|Outcome|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
1049373|NCT00698646|O2|Outcome|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
1049374|NCT00698646|O1|Outcome|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
1049375|NCT00698646|O3|Outcome|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
1049376|NCT00698646|O2|Outcome|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
1049377|NCT00698646|O1|Outcome|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
1049378|NCT00698646|O3|Outcome|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
1049379|NCT00698646|O2|Outcome|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
1049380|NCT00698646|O1|Outcome|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
1049381|NCT00698646|O3|Outcome|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
1049382|NCT00698646|O2|Outcome|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
1049383|NCT00698646|O1|Outcome|Valsartan|At week 0 patients received Valsartan 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12
1049385|NCT00698646|E2|Reported Event|HCTZ|At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
1049386|NCT00698646|E1|Reported Event|Valsartan + HCTZ|At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
1049387|NCT00698581|B3|Baseline|Total Title|
1049388|NCT00698581|B2|Baseline|Brivaracetam 100 mg/Day|Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
1049389|NCT00698581|B1|Baseline|Brivaracetam 50 mg/Day|Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)
1049390|NCT00698581|P2|Participant Flow|Brivaracetam 100 mg/Day|Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
1049391|NCT00698581|P1|Participant Flow|Brivaracetam 50 mg/Day|Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)
1049392|NCT00698581|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
1049393|NCT00698581|O1|Outcome|Brivaracetam 50 mg/Day|Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)
1049394|NCT00698581|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
1049395|NCT00698581|O1|Outcome|Brivaracetam 50 mg/Day|Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)
1049396|NCT00698581|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
1049397|NCT00698581|O1|Outcome|Brivaracetam 50 mg/Day|Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)
1049398|NCT00698581|O1|Outcome|Efficacy Analysis Set (BRV 50 mg/Day Treated Subjects)|The Efficacy Analysis Set (EFF) consists of all randomized subjects with at least one intake of study medication who also entered into the Baseline antiepileptic drug (AED) Tapering Period and started the withdrawal of Baseline AEDs.
1049399|NCT00698581|E2|Reported Event|Brivaracetam 100 mg/Day|Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
1049400|NCT00698581|E1|Reported Event|Brivaracetam 50 mg/Day|Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study)
1049401|NCT00698516|B1|Baseline|Topotecan and Bevacizumab|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles.
1049402|NCT00698516|P1|Participant Flow|Topotecan and Bevacizumab|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles.
1049403|NCT00698516|O3|Outcome|Topotecan and Bevacizumab: All Participants|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. This groups consists of both resistant and sensitive participants.
1049404|NCT00698516|O2|Outcome|Topotecan and Bevacizumab: Sensitive Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was &gt;90 days; therefore, these participants were termed sensitive."
1049405|NCT00698516|O1|Outcome|Topotecan and Bevacizumab: Resistant Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was <= 90 days; therefore, these participants were termed resistant."
1049406|NCT00698516|O1|Outcome|Topotecan and Bevacizumab|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles.
1049407|NCT00698516|O1|Outcome|Topotecan and Bevacizumab|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles.
1049408|NCT00698516|O3|Outcome|Topotecan and Bevacizumab: All Participants|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. This groups consists of both resistant and sensitive participants.
1049409|NCT00698516|O2|Outcome|Topotecan and Bevacizumab: Sensistive Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was &gt;90 days; therefore, these participants were termed sensitive."
1049410|NCT00698516|O1|Outcome|Topotecan and Bevacizumab: Resistant Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was <= 90 days; therefore, these participants were termed resistant."
1049411|NCT00698516|O3|Outcome|Topotecan and Bevacizumab: All Participants|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. This groups consists of both resistant and sensitive participants.
1049412|NCT00698516|O2|Outcome|Topotecan and Bevacizumab: Sensitive Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was &gt;90 days; therefore, these participants were termed sensitive."
1049413|NCT00698516|O1|Outcome|Topotecan and Bevacizumab: Resistant Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was <= 90 days; therefore, these participants were termed resistant."
1049414|NCT00698516|O3|Outcome|Topotecan and Bevacizumab: All Participants|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. This groups consists of both resistant and sensitive participants.
1049415|NCT00698516|O2|Outcome|Topotecan and Bevacizumab: Sensitive Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was &gt;90 days; therefore, these participants were termed sensitive."
1049416|NCT00698516|O1|Outcome|Topotecan and Bevacizumab: Resistant Participants|"Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles. The time to progression from the end of prior chemotherapy was <= 90 days; therefore, these participants were termed resistant."
1049417|NCT00698516|O1|Outcome|Topotecan and Bevacizumab|Participants were to receive oral topotecan 2.3 milligrams (mg)/meters squared (m^2)/day for 5 consecutive days (Days 1 to 5) and intravenous (IV) bevacizumab 15 mg/kilograms (kg) on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GlaxoSmithKline’s study physician was needed for participants who required treatment beyond 8 cycles.
1049468|NCT00698035|O2|Outcome|E2 by RIA|Additional measurement of baseline and week 4 E2 by RIA
1049604|NCT00697515|O2|Outcome|Placebo|Placebo is administered once-daily
1049418|NCT00698516|E1|Reported Event|Topotecan and Bevacizumab|Participants were to receive oral topotecan 2.3 mg/m^2/day for 5 consecutive days (Days 1 to 5) and IV bevacizumab 15 mg/kg on Day 1 of each 21-day cycle. Treatment was to be continued for up to 8 cycles (a minimum of 4 cycles was recommended) or until disease progression or development of unacceptable toxicity, whichever occurred first. Prior approval from GSK’s study physician was needed for subjects who required treatment beyond 8 cycles.
1049419|NCT00698451|B1|Baseline|DOXIL/CARBOPLATIN/BEVACIZUMAB|Doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle Intervention.
1049420|NCT00698451|P1|Participant Flow|DOXIL/CARBOPLATIN/BEVACIZUMAB|Doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle Intervention.
1049421|NCT00698451|O1|Outcome|DOXIL/CARBOPLATIN/BEVACIZUMAB|doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle
1049422|NCT00698451|O1|Outcome|DOXIL/CARBOPLATIN/BEVACIZUMAB|doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle
1049423|NCT00698451|E1|Reported Event|DOXIL/CARBOPLATIN/BEVACIZUMAB|Doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle Intervention.
1049424|NCT00698204|B3|Baseline|Total|Total of all reporting groups
1049425|NCT00698204|B2|Baseline|II- Placebo|placebo: Subject was randomized to take placebo each day that radiation therapy was given.
1049426|NCT00698204|B1|Baseline|I- Celecoxib|celecoxib: Subject was randomized to take celecoxib each day that radiation therapy was given.
1049427|NCT00698204|P2|Participant Flow|II- Placebo|placebo: Subject was randomized to take an identical placebo each day that radiation therapy was given (6-7 week period).
1049428|NCT00698204|P1|Participant Flow|I- Celecoxib|celecoxib: Subjects were randomized to take celecoxib each day that radiation therapy was given (6-7 week period).
1049429|NCT00698204|O2|Outcome|II- Placebo|placebo: Subject was randomized to take placebo each day that radiation therapy was given.
1049430|NCT00698204|O1|Outcome|I- Celecoxib|celecoxib: Subject was randomized to take celecoxib each day that radiation therapy was given.
1049431|NCT00698204|O2|Outcome|II- Placebo|placebo: Subject was randomized to take an identical placebo each day that radiation therapy was given (6-7 week period).
1049432|NCT00698204|O1|Outcome|I- Celecoxib|celecoxib: Subjects were randomized to take celecoxib each day that radiation therapy was given (6-7 week period).
1049433|NCT00698204|E2|Reported Event|II- Placebo|placebo: Subject was randomized to take an identical placebo each day that radiation therapy was given (6-7 week period).
1049434|NCT00698204|E1|Reported Event|I- Celecoxib|celecoxib: Subjects were randomized to take celecoxib each day that radiation therapy was given (6-7 week period).
1049435|NCT00698139|B4|Baseline|Total|Total of all reporting groups
1049436|NCT00698139|B3|Baseline|Intervention Only|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour."
1049437|NCT00698139|B2|Baseline|Control First, Then Intervention|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter."
1049438|NCT00698139|B1|Baseline|Intervention First, Then Control|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter."
1049439|NCT00698139|P3|Participant Flow|Intervention Only|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour."
1049469|NCT00698035|O1|Outcome|E2 by LC/MS|A commercially available ultrasensitive E2 level was measured at baseline and 4 weeks (Quest Diagnostics, liquid chromatography tandem mass spectrometry (LC/MS, PM range <10 pg/ml)
1049921|NCT00696618|E1|Reported Event|Hypo-osmolar Enema|Hypo-osmolar Tap water enema
1049440|NCT00698139|P2|Participant Flow|Control First, Then Intervention|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter."
1049441|NCT00698139|P1|Participant Flow|Intervention First, Then Control|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter."
1049442|NCT00698139|O3|Outcome|Intervention Only|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour."
1049443|NCT00698139|O2|Outcome|Control First, Then Intervention|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter."
1049444|NCT00698139|O1|Outcome|Intervention First, Then Control|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter."
1049445|NCT00698139|O3|Outcome|Intervention Only|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour."
1049446|NCT00698139|O2|Outcome|Control First, Then Intervention|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter."
1049447|NCT00698139|O1|Outcome|Intervention First, Then Control|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter."
1049470|NCT00698035|O2|Outcome|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
1049471|NCT00698035|O1|Outcome|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
1050088|NCT00696241|B6|Baseline|Total|Total of all reporting groups
1049448|NCT00698139|O3|Outcome|Intervention Only|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour."
1049449|NCT00698139|O2|Outcome|Control First, Then Intervention|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter."
1049450|NCT00698139|O1|Outcome|Intervention First, Then Control|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter."
1049451|NCT00698139|E3|Reported Event|Intervention Only|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~Patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour."
1049452|NCT00698139|E2|Reported Event|Control First, Then Intervention|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, the control group will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. The rest of the protocol will be as described for the first encounter."
1049453|NCT00698139|E1|Reported Event|Intervention First, Then Control|"Ambulatory out-patients will be identified at Columbia-Presbyterian and New York University Medical Centers.~On the first encounter, patients will come to clinic in the morning for baseline measurements. Subsequently, the atrial pacing rate will be increased to 85bpm for 6 hours. Patients will eat a standard breakfast provided by the hospital prior to the treatment session, and then will fast for the six-hour observation period. Patients will remain in supine position and will be clinically monitored for 6 hours. All patients will be on continuous cardiac monitors. Vital signs and symptoms of congestion/ischemia will be recorded every hour.~On the second encounter, patients will come to clinic in the morning for baseline measurements.Subsequently, they will be given the illusion that their pacer has been adjusted, but the settings will remain unchanged. The rest of the protocol will be as described for the first encounter."
1049454|NCT00698035|B3|Baseline|Total|Total of all reporting groups
1049455|NCT00698035|B2|Baseline|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
1049456|NCT00698035|B1|Baseline|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
1049457|NCT00698035|P2|Participant Flow|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
1049458|NCT00698035|P1|Participant Flow|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
1049459|NCT00698035|O2|Outcome|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
1049460|NCT00698035|O1|Outcome|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
1049461|NCT00698035|O2|Outcome|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
1049462|NCT00698035|O1|Outcome|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
1049463|NCT00698035|O2|Outcome|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
1049464|NCT00698035|O1|Outcome|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
1049465|NCT00698035|O1|Outcome|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
1049466|NCT00698035|O2|Outcome|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
1049467|NCT00698035|O1|Outcome|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
1049472|NCT00698035|E2|Reported Event|Testosterone Cream|Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
1049473|NCT00698035|E1|Reported Event|Estring|Estring 2mg ring inserted vaginally once every 12 weeks
1049474|NCT00698022|B4|Baseline|Total|Total of all reporting groups
1049475|NCT00698022|B3|Baseline|Risperidone-matched Placebo Plus Mifepristone|risperidone-matched placebo plus mifepristone daily
1049476|NCT00698022|B2|Baseline|Risperidone Plus Mifepristone-matched Placebo|risperidone plus mifepristone-matched placebo daily
1049477|NCT00698022|B1|Baseline|Mifepristone Plus Risperidone|mifepristone plus risperidone daily
1049478|NCT00698022|P3|Participant Flow|Risperidone-matched Placebo Plus Mifepristone|risperidone-matched placebo plus mifepristone daily
1049479|NCT00698022|P2|Participant Flow|Risperidone Plus Mifepristone-matched Placebo|risperidone plus mifepristone-matched placebo daily
1049480|NCT00698022|P1|Participant Flow|Mifepristone Plus Risperidone|mifepristone plus risperidone daily
1049481|NCT00698022|O3|Outcome|Risperidone-matched Placebo Plus Mifepristone|risperidone-matched placebo plus mifepristone daily
1049482|NCT00698022|O2|Outcome|Risperidone Plus Mifepristone-matched Placebo|risperidone plus mifepristone-matched placebo daily
1049483|NCT00698022|O1|Outcome|Mifepristone Plus Risperidone|mifepristone plus risperidone daily
1049484|NCT00698022|E3|Reported Event|Risperidone-matched Placebo Plus Mifepristone|risperidone-matched placebo plus mifepristone daily
1049485|NCT00698022|E2|Reported Event|Risperidone Plus Mifepristone-matched Placebo|risperidone plus mifepristone-matched placebo daily
1049486|NCT00698022|E1|Reported Event|Mifepristone Plus Risperidone|mifepristone plus risperidone daily
1049487|NCT00698009|B1|Baseline|Fludarabine + Cyclophosphamide + NK Cell Infusion|Fludarabine 25 mg/m^2 intravenous (IV) Daily Over 30 minutes Starting 6 days before the NK cell infusion (considered Day -6) and once a day through Day -2. Cyclophosphamide 60 mg/kg IV Daily Over 2 Hours On Days -5 and -4. Natural Killer Cell Infusion on Day 0. Mesna 12 mg/kg By Vein, Over about 15 minutes, 5 Times Per Day on Days -5 and -4. Interleukin-2 subcutaneously three times weekly for 9 total doses following NK Cell Infusion.
1049488|NCT00698009|P1|Participant Flow|Fludarabine + Cyclophosphamide + NK Cell Infusion|Fludarabine 25 mg/m^2 intravenous (IV) Daily Over 30 minutes Starting 6 days before the NK cell infusion (considered Day -6) and once a day through Day -2. Cyclophosphamide 60 mg/kg IV Daily Over 2 Hours On Days -5 and -4. Natural Killer Cell Infusion on Day 0. Mesna 12 mg/kg By Vein, Over about 15 minutes, 5 Times Per Day on Days -5 and -4. Interleukin-2 subcutaneously three times weekly for 9 total doses following NK Cell Infusion.
1049489|NCT00698009|O1|Outcome|Fludarabine + Cyclophosphamide + NK Cell Infusion|Fludarabine 25 mg/m^2 intravenous (IV) Daily Over 30 minutes Starting 6 days before the NK cell infusion (considered Day -6) and once a day through Day -2. Cyclophosphamide 60 mg/kg IV Daily Over 2 Hours On Days -5 and -4. Natural Killer Cell Infusion on Day 0. Mesna 12 mg/kg By Vein, Over about 15 minutes, 5 Times Per Day on Days -5 and -4. Interleukin-2 subcutaneously three times weekly for 9 total doses following NK Cell Infusion.
1049490|NCT00698009|E1|Reported Event|Fludarabine + Cyclophosphamide + NK Cell Infusion|Fludarabine 25 mg/m^2 intravenous (IV) Daily Over 30 minutes Starting 6 days before the NK cell infusion (considered Day -6) and once a day through Day -2. Cyclophosphamide 60 mg/kg IV Daily Over 2 Hours On Days -5 and -4. Natural Killer Cell Infusion on Day 0. Mesna 12 mg/kg By Vein, Over about 15 minutes, 5 Times Per Day on Days -5 and -4. Interleukin-2 subcutaneously three times weekly for 9 total doses following NK Cell Infusion.
1049491|NCT00697827|B3|Baseline|Total|Total of all reporting groups
1049492|NCT00697827|B2|Baseline|X-Stop|The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
1049493|NCT00697827|B1|Baseline|In-Space|The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5.
1049494|NCT00697827|P2|Participant Flow|X-Stop|The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
1049495|NCT00697827|P1|Participant Flow|In-Space|The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5.
1049496|NCT00697827|O2|Outcome|X-Stop|The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
1049533|NCT00697619|B2|Baseline|Control Group|Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.
1049605|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
1049497|NCT00697827|O1|Outcome|In-Space|The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5.
1049498|NCT00697827|O2|Outcome|X-Stop|The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
1049499|NCT00697827|O1|Outcome|In-Space|The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5.
1049500|NCT00697827|E2|Reported Event|X-Stop|The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
1049501|NCT00697827|E1|Reported Event|In-Space|The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5.
1049502|NCT00697801|B4|Baseline|Total|Total of all reporting groups
1049503|NCT00697801|B3|Baseline|Placebo|Placebo delivered by nebulization twice daily for 6 weeks
1049504|NCT00697801|B2|Baseline|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
1049505|NCT00697801|B1|Baseline|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
1049506|NCT00697801|P3|Participant Flow|Placebo|Placebo delivered by nebulization twice daily for 6 weeks
1049507|NCT00697801|P2|Participant Flow|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
1049508|NCT00697801|P1|Participant Flow|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
1049509|NCT00697801|O3|Outcome|Placebo|Placebo delivered by nebulization twice daily for 6 weeks
1049510|NCT00697801|O2|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
1049511|NCT00697801|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
1049512|NCT00697801|O3|Outcome|Placebo|Placebo delivered by nebulization twice daily for 6 weeks
1049513|NCT00697801|O2|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
1049514|NCT00697801|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
1049515|NCT00697801|O3|Outcome|Placebo|Placebo delivered by nebulization twice daily for 6 weeks
1049516|NCT00697801|O2|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
1049517|NCT00697801|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
1049518|NCT00697801|E3|Reported Event|Placebo|Placebo delivered by nebulization twice daily for 6 weeks
1049519|NCT00697801|E2|Reported Event|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
1049520|NCT00697801|E1|Reported Event|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
1049521|NCT00697697|B3|Baseline|Total|Total of all reporting groups
1049522|NCT00697697|B2|Baseline|0.25mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
1049523|NCT00697697|B1|Baseline|0.135mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
1049524|NCT00697697|P2|Participant Flow|0.25mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
1049525|NCT00697697|P1|Participant Flow|0.135mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
1049526|NCT00697697|O2|Outcome|0.25mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
1049527|NCT00697697|O1|Outcome|0.135mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
1049528|NCT00697697|O2|Outcome|0.25mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
1049529|NCT00697697|O1|Outcome|0.135mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
1049530|NCT00697697|E2|Reported Event|0.25mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
1049531|NCT00697697|E1|Reported Event|0.135mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
1049532|NCT00697619|B3|Baseline|Total|Total of all reporting groups
1049534|NCT00697619|B1|Baseline|Test Group|Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy.
1049535|NCT00697619|P2|Participant Flow|Control Group|Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.
1049536|NCT00697619|P1|Participant Flow|Test Group|Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy.
1049537|NCT00697619|O2|Outcome|Control Group|Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.
1049538|NCT00697619|O1|Outcome|Test Group|Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy.
1049539|NCT00697619|E2|Reported Event|Control Group|Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.
1049540|NCT00697619|E1|Reported Event|Test Group|Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy.
1049541|NCT00697593|B1|Baseline|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
1049542|NCT00697593|P1|Participant Flow|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
1049543|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
1049544|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
1049545|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
1049546|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
1049547|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
1049548|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
1049549|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
1049550|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
1049551|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
1049552|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
1049553|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
1049554|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
1049555|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
1049556|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
1049557|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
1049558|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
1049559|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
1049560|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
1049561|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
1049562|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
1049600|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
1049563|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
1049564|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
1049565|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
1049566|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
1049567|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
1049568|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
1049569|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
1049570|NCT00697593|O1|Outcome|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
1049571|NCT00697593|E1|Reported Event|Efalizumab|Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
1049572|NCT00697541|B3|Baseline|Total|Total of all reporting groups
1049573|NCT00697541|B2|Baseline|Seq2-vehicle+Brimonidine Drops,Then Facial Gel+Saline Drops|"One 1-g application of COL-118 facial gel vehicle (0.0 mg brimonidine tartrate) administered topically plus one drop of 0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop) in each eye. Four hours after the first application 1-g of COL-118 facial gel vehicle (0.0 mg brimonidine) is administered topically~First intervention (1 day), washout (1 day), Second intervention (1 day)"
1049574|NCT00697541|B1|Baseline|Seq1-facial Gel+Saline Drops,Then Vehicle+Brimonidine Drops|"One (1) gram of 0.18% COL-118 facial gel (1.8 mg brimonidine tartrate) administered topically plus 1 drop of Advanced Eye Relief™ (placebo ophthalmic solution) in each eye, once in the morning. One (1) gram of 0.18% COL-118 facial gel was to be reapplied once after 4 hours.~First intervention (1 day), washout (1 day), Second intervention (1 day)"
1049575|NCT00697541|P2|Participant Flow|Seq2-vehicle+Brimonidine Drops,Then Facial Gel+Saline Drops|"One 1-g application of COL-118 facial gel vehicle (0.0 mg brimonidine tartrate) administered topically plus one drop of 0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop) in each eye. Four hours after the first application 1-g of COL-118 facial gel vehicle (0.0 mg brimonidine) is administered topically~First intervention (1 day), washout (1 day), Second intervention (1 day)"
1049576|NCT00697541|P1|Participant Flow|Seq1-facial Gel+Saline Drops,Then Vehicle+Brimonidine Drops|"One (1) gram of 0.18% COL-118 facial gel (1.8 mg brimonidine tartrate) administered topically plus 1 drop of Advanced Eye Relief™ (placebo ophthalmic solution) in each eye, once in the morning. One (1) gram of 0.18% COL-118 facial gel was to be reapplied once after 4 hours.~First intervention (1 day), washout (1 day), Second intervention (1 day)"
1049577|NCT00697541|O2|Outcome|Treatment B - Vehicle Gel + Brimonidine Drops|Vehicle gel + brimonidine drops
1049578|NCT00697541|O1|Outcome|Treatment A - COL-118 Facial Gel + Saline Drops|COL-118 facial gel + saline drops
1049579|NCT00697541|O2|Outcome|Treatment B - Vehicle Gel + Brimonidine Drops|Vehicle gel + brimonidine drops
1049580|NCT00697541|O1|Outcome|Treatment A - COL-118 Gel + Saline Drops|COL-118 gel + saline drops
1049581|NCT00697541|O2|Outcome|Treatment B - Vehicle Gel + Brimonidine Drops|Vehicle gel + brimonidine drops
1049582|NCT00697541|O1|Outcome|Treatment A - COL-118 Facial Gel + Saline Drops|COL-118 facial gel + saline drops
1049583|NCT00697541|E2|Reported Event|Treatment B|Vehicle gel + brimonidine drops
1049584|NCT00697541|E1|Reported Event|Treatment A|COL-118 gel + saline drops
1049585|NCT00697515|B1|Baseline|Entire Study Population|
1049586|NCT00697515|P2|Participant Flow|Placebo First|Placebo is administered once-daily for 1 week in the first intervention and Lisdexamfetamine Dimesylate (LDX, SPD489)is dosed once-daily at 30, 50 or 70 mg for 1 week during the second intervention.
1049587|NCT00697515|P1|Participant Flow|SPD489 First|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg for 1 week during the first intervention and placebo is administered once-daily for 1 week in the second intervention.
1049588|NCT00697515|O2|Outcome|Placebo|Placebo is administered once-daily
1049589|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
1049590|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
1049591|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
1049592|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
1049593|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
1049594|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
1049595|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
1049596|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
1049597|NCT00697515|O2|Outcome|Placebo|Placebo is administered once-daily
1049598|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
1049599|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
1049607|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
1049608|NCT00697515|O2|Outcome|Placebo|Placebo is administered once-daily
1049609|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
1049610|NCT00697515|O2|Outcome|Placebo|Placebo is administered once-daily
1049611|NCT00697515|O1|Outcome|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
1049612|NCT00697515|E2|Reported Event|Placebo|Placebo is administered once-daily for 1 week in the first intervention and Lisdexamfetamine Dimesylate (LDX, SPD489)is dosed once-daily at 30, 50 or 70 mg for 1 week during the second intervention.
1049613|NCT00697515|E1|Reported Event|SPD489|Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg for 1 week during the first intervention and placebo is administered once-daily for 1 week in the second intervention.
1049614|NCT00697255|B3|Baseline|Total|Total of all reporting groups
1049615|NCT00697255|B2|Baseline|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
1049616|NCT00697255|B1|Baseline|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
1049617|NCT00697255|P2|Participant Flow|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
1049618|NCT00697255|P1|Participant Flow|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
1049619|NCT00697255|O2|Outcome|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
1049620|NCT00697255|O1|Outcome|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
1049621|NCT00697255|O2|Outcome|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
1049622|NCT00697255|O1|Outcome|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
1049623|NCT00697255|O2|Outcome|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
1049641|NCT00697190|O1|Outcome|Senofilcon A|This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
1049642|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all oblique astigmat subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
1049882|NCT00696761|P3|Participant Flow|BOOI<20, BCI≥ 100|"BOOI<20, BCI≥ 100)~alfuzosin : 10mg, once daily, 12months"
1049624|NCT00697255|O1|Outcome|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
1049625|NCT00697255|O2|Outcome|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
1049626|NCT00697255|O1|Outcome|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
1049627|NCT00697255|O2|Outcome|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
1049628|NCT00697255|O1|Outcome|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
1049629|NCT00697255|O2|Outcome|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
1049630|NCT00697255|O1|Outcome|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
1049631|NCT00697255|E2|Reported Event|Corifollitropin Alfa + hCG|Eligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
1049632|NCT00697255|E1|Reported Event|Corifollitropin Alfa + recFSH|Eligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.
1049633|NCT00697190|B1|Baseline|All Completed Subjects|All subjects that completed the study were analyzed. One subject from the senofilcon A/ galyfilcon A arm dropped from the study between the first and second intervention. The subject moved out of town.
1049634|NCT00697190|P2|Participant Flow|Galyfilcon A/Senofilcon A|galyfilcon A silicone hydrogel toric contact lenses worn first. senofilcon A silicone hydrogel toric contact lenses worn second.
1049635|NCT00697190|P1|Participant Flow|Senofilcon A/Galyfilcon A|senofilcon A silicone hydrogel toric contact lenses will be worn first. galyfilcon A silicone hydrogel toric contact lenses will be worn second.
1049636|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all oblique astigmat subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
1049637|NCT00697190|O1|Outcome|Senofilcon A|This group represents all oblique astigmat subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
1049638|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all hyperope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
1049639|NCT00697190|O1|Outcome|Senofilcon A|This group represents all hyperope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
1049640|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
1049643|NCT00697190|O1|Outcome|Senofilcon A|This group represents all oblique astigmat subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
1049644|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all hyperope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
1049645|NCT00697190|O1|Outcome|Senofilcon A|This group represents all hyperope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
1049646|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
1049647|NCT00697190|O1|Outcome|Senofilcon A|This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
1049648|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all oblique astigmat subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
1049649|NCT00697190|O1|Outcome|Senofilcon A|This group represents all oblique astigmat subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
1049650|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all hyperope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
1049651|NCT00697190|O1|Outcome|Senofilcon A|This group represents all hyperope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
1049652|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
1049653|NCT00697190|O1|Outcome|Senofilcon A|This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
1049654|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all oblique astigmat subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
1049655|NCT00697190|O1|Outcome|Senofilcon A|This group represents all oblique astigmat subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
1049656|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all hyperope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
1049657|NCT00697190|O1|Outcome|Senofilcon A|This group represents all hyperope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
1049658|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
1049659|NCT00697190|O1|Outcome|Senofilcon A|This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
1049660|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all oblique astigmat subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
1049661|NCT00697190|O1|Outcome|Senofilcon A|This group represents all oblique astigmat subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
1049662|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all hyperope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
1049663|NCT00697190|O1|Outcome|Senofilcon A|This group represents all hyperope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
1049664|NCT00697190|O2|Outcome|Galyfilcon A|This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
1049665|NCT00697190|O1|Outcome|Senofilcon A|This group represents all high myope subjects that completed the study and wore senofilcon A toric contact lenses as first or second intervention.
1049666|NCT00697190|E2|Reported Event|Galyfilcon A|galyfilcon A silicone hydrogel toric contact lenses worn in the first or second intervention.
1049667|NCT00697190|E1|Reported Event|Senofilcon A|senofilcon A silicone hydrogel toric contact lenses worn in the first or second intervention.
1049668|NCT00697112|B1|Baseline|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
1049669|NCT00697112|P1|Participant Flow|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
1049670|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
1049671|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
1049836|NCT00696787|E1|Reported Event|Placebo|In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
1049672|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
1049673|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
1049674|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
1049675|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
1049676|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
1049677|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
1049678|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
1049679|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
1049680|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
1049681|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
1049682|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
1049683|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
1049684|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
1049837|NCT00696774|B4|Baseline|Total|Total of all reporting groups
1049685|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
1049686|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
1049687|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
1049688|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
1049689|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
1049690|NCT00697112|O1|Outcome|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
1049691|NCT00697112|E1|Reported Event|Sirolimus|Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than [>] 1.5 milligram per deciliter [mg/dL], cerebrovascular accident as cause of death or history of hypertension).
1049692|NCT00697073|B1|Baseline|High Dose Idebenone|"Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day (3 x 150 mg tablets, t.i.d.)~Patients > 45 kg/99 lbs: idebenone 2250 mg/day (5 x 150 mg tablets, t.i.d.)"
1049693|NCT00697073|P1|Participant Flow|High Dose Idebenone|"Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day (3 x 150 mg tablets, t.i.d.)~Patients > 45 kg/99 lbs: idebenone 2250 mg/day (5 x 150 mg tablets, t.i.d.)"
1049694|NCT00697073|O1|Outcome|High Dose Idebenone|"Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day (3 x 150 mg tablets, t.i.d.)~Patients > 45 kg/99 lbs: idebenone 2250 mg/day (5 x 150 mg tablets, t.i.d.)"
1049695|NCT00697073|E1|Reported Event|High Dose Idebenone|"Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day (3 x 150 mg tablets, t.i.d.)~Patients > 45 kg/99 lbs: idebenone 2250 mg/day (5 x 150 mg tablets, t.i.d.)"
1049696|NCT00696878|B1|Baseline|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049697|NCT00696878|P1|Participant Flow|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of Gonadotropin Releasing Hormone (GnRH) antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of recombinant Human Chorion Gonadotropin ([rec]hCG) (5,000-10,000 IU/250 µg). Daily dosing with Follicle Stimulating Hormone (FSH) (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer (FTET) cycles (up to 3 after each COS cycle) could occur.
1049698|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049838|NCT00696774|B3|Baseline|Unclassified|Participants who received 60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II) with unknown response status.
1049839|NCT00696774|B2|Baseline|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
1049699|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049700|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049701|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049702|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049703|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049704|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049705|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049706|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049707|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049708|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049709|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049710|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049711|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049712|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049713|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049714|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049715|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049716|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049717|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049718|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049719|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049720|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049721|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049722|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049723|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049724|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049725|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049726|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049727|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049728|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049729|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049730|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049731|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049732|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049733|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049734|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049735|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049736|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049737|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049738|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049739|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049740|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049741|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049742|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049743|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049744|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049745|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049746|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049747|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049748|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049749|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049750|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049751|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049752|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049753|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049754|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049755|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049756|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049757|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049758|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049759|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049760|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049761|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049762|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049763|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049764|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049765|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049766|NCT00696878|O1|Outcome|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049767|NCT00696878|E1|Reported Event|Corifollitropin Alfa 150 µg|Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, FTET cycles (up to 3 after each COS cycle) could occur.
1049768|NCT00696800|B3|Baseline|Total|Total of all reporting groups
1049769|NCT00696800|B2|Baseline|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049770|NCT00696800|B1|Baseline|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049771|NCT00696800|P2|Participant Flow|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049772|NCT00696800|P1|Participant Flow|150 µg Corifollitropin Alfa|Participants received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recombinant Follicle Stimulating Hormone (recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human Chorionogonadotropin (hCG); multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of oocyte pick up (OPU) daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049773|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049774|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049775|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049776|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049840|NCT00696774|B1|Baseline|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
1049841|NCT00696774|P3|Participant Flow|Unclassified|Participants who received 60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II) with unknown response status.
1049777|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049778|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049779|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049780|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049781|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049782|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049783|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049784|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049785|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049786|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049787|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049788|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049842|NCT00696774|P2|Participant Flow|Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-Responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
1049883|NCT00696761|P2|Participant Flow|BOOI≥20, BCI< 100|"BOOI≥ 20, BCI<100~alfuzosin : 10mg, once daily, 12months"
1049789|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049790|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049791|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049792|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049793|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049794|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049795|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049796|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049797|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049798|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049799|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049800|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049843|NCT00696774|P1|Participant Flow|Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
1049919|NCT00696618|E3|Reported Event|Hyper-osmolar Enema|Fleet Hyper-osmolar enema
1049801|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049802|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049803|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049804|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049805|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049806|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049807|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049808|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049809|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049810|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049811|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049812|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049844|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
1049920|NCT00696618|E2|Reported Event|Iso-osmolar Enema|Normosol-R Iso-osmolar enema
1049813|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049814|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049815|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049816|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049817|NCT00696800|O2|Outcome|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049818|NCT00696800|O1|Outcome|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049819|NCT00696800|E2|Reported Event|200 IU recFSH|Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049820|NCT00696800|E1|Reported Event|150 µg Corifollitropin Alfa|Participants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.
1049821|NCT00696787|B4|Baseline|Total|Total of all reporting groups
1049822|NCT00696787|B3|Baseline|Pregabalin|In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
1049823|NCT00696787|B2|Baseline|DVS SR|In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
1049824|NCT00696787|B1|Baseline|Placebo|In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
1049825|NCT00696787|P3|Participant Flow|Pregabalin|In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
1049826|NCT00696787|P2|Participant Flow|DVS SR|In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
1049827|NCT00696787|P1|Participant Flow|Placebo|In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
1049828|NCT00696787|O3|Outcome|Pregabalin|In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
1049829|NCT00696787|O2|Outcome|DVS SR|In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
1049830|NCT00696787|O1|Outcome|Placebo|In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
1049831|NCT00696787|O3|Outcome|Pregabalin|In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
1049832|NCT00696787|O2|Outcome|DVS SR|In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
1049833|NCT00696787|O1|Outcome|Placebo|In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
1049834|NCT00696787|E3|Reported Event|Pregabalin|In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
1049835|NCT00696787|E2|Reported Event|DVS SR|In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
1049881|NCT00696761|P4|Participant Flow|BOOI<20, BCI< 100|"BOOI<20, BCI<100~alfuzosin : 10mg, once daily, 12 months"
1049845|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
1049846|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
1049847|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
1049848|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
1049849|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
1049850|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
1049851|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
1049852|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
1049853|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
1049854|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
1049855|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
1049856|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
1049857|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
1049858|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
1049859|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
1049860|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
1049861|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
1049862|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
1049863|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
1049864|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
1049865|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
1049866|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
1049867|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
1049868|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
1049869|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
1049870|NCT00696774|O1|Outcome|Duloxetine|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks. Responder group - 60 mg capsules, QD, for 4 weeks more. Non-responder group - 120 mg capsules, QD, for 4 weeks more.
1049871|NCT00696774|O2|Outcome|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
1049872|NCT00696774|O1|Outcome|Duloxetine Responders|60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
1049873|NCT00696774|E3|Reported Event|Unclassified|Participants who received 60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II) with unknown response status.
1049874|NCT00696774|E2|Reported Event|Duloxetine Non-Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-Responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
1049875|NCT00696774|E1|Reported Event|Duloxetine Responders|60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
1049876|NCT00696761|B5|Baseline|Total|Total of all reporting groups
1049877|NCT00696761|B4|Baseline|group2|"BOOI≥ 20, BCI<100~alfuzosin : 10mg, once daily, 12months"
1049878|NCT00696761|B3|Baseline|group1|"BOOI≥ 20, BCI≥ 100~alfuzosin : 10mg, once daily, 12months"
1049879|NCT00696761|B2|Baseline|Group 4|"BOOI<20, BCI<100~alfuzosin : 10mg, once daily, 12 months"
1049880|NCT00696761|B1|Baseline|Group 3|"BOOI<20, BCI≥ 100)~alfuzosin : 10mg, once daily, 12months"
1049884|NCT00696761|P1|Participant Flow|BOOI≥20, BCI≥ 100|"Bladder outlet obstruction index(BOOI)≥ 20, bladder contractility index (BCI)≥ 100~alfuzosin : 10mg, once daily, 12months"
1049885|NCT00696761|O4|Outcome|group2|"BOOI≥ 20, BCI<100~alfuzosin : 10mg, once daily, 12months"
1049886|NCT00696761|O3|Outcome|group1|"BOOI≥ 20, BCI≥ 100~alfuzosin : 10mg, once daily, 12months"
1049887|NCT00696761|O2|Outcome|Group 4|"BOOI<20, BCI<100~alfuzosin : 10mg, once daily, 12 months"
1049888|NCT00696761|O1|Outcome|Group 3|"BOOI<20, BCI≥ 100)~alfuzosin : 10mg, once daily, 12months"
1049889|NCT00696761|O4|Outcome|BOOI<20, BCI<100|"BOOI<20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month.~alfuzosin: 10mg, once daily, 12 months"
1049890|NCT00696761|O3|Outcome|BOOI<20, BCI≥ 100|"BOOI<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.~alfuzosin: 10mg, once daily, 12months"
1049891|NCT00696761|O2|Outcome|BOOI≥ 20, BCI<100|"BOOI≥ 20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month.~alfuzosin: 10mg, once daily, 12months"
1049892|NCT00696761|O1|Outcome|BOOI≥ 20, BCI≥100|"Bladder outlet obstruction index(BOOI)≥ 20, Bladder contractility index(BCI)≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.~alfuzosin: 10mg, once daily, 12months"
1049893|NCT00696761|E4|Reported Event|group2|"BOOI≥ 20, BCI<100~alfuzosin : 10mg, once daily, 12months"
1049894|NCT00696761|E3|Reported Event|group1|"BOOI≥ 20, BCI≥ 100~alfuzosin : 10mg, once daily, 12months"
1049895|NCT00696761|E2|Reported Event|Group 4|"BOOI<20, BCI<100~alfuzosin : 10mg, once daily, 12 months"
1049896|NCT00696761|E1|Reported Event|Group 3|"BOOI<20, BCI≥ 100)~alfuzosin : 10mg, once daily, 12months"
1049897|NCT00696696|B1|Baseline|Combination GES|Combination of Gemcitabine, Erlotinib, and Sorafenib
1049898|NCT00696696|P1|Participant Flow|Combination GES|Combination of Gemcitabine, Erlotinib, and Sorafenib
1049899|NCT00696696|O1|Outcome|Combination GES|Combination of Gemcitabine, Erlotinib, and Sorafenib
1049900|NCT00696696|O1|Outcome|Combination GES|Combination of Gemcitabine, Erlotinib, and Sorafenib
1049901|NCT00696696|O1|Outcome|Combination GES|Combination of Gemcitabine, Erlotinib, and Sorafenib
1049902|NCT00696696|E1|Reported Event|Combination GES|Combination of Gemcitabine, Erlotinib, and Sorafenib
1049903|NCT00696618|B4|Baseline|Total|Total of all reporting groups
1049904|NCT00696618|B3|Baseline|Fleet/Tap Water/Normosol-R|"Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 2), Followed by Normosol-R enema(iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3)~Fleet Enema: hyper-osmolar preparation~tap water enema: hypo-osmolar preparation~Normosol-R enema: iso-osmolar preparation"
1049905|NCT00696618|B2|Baseline|Normosol-R/Fleet/Tap Water|"Normosol-R enema (iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 2), Followed by Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3)~Fleet Enema: hyper-osmolar preparation~tap water enema: hypo-osmolar preparation~Normosol-R enema: iso-osmolar preparation"
1049906|NCT00696618|B1|Baseline|Tap Water/Normosol-R/Fleet|"Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Normosol-R enema (iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home(Stage 2), Followed by Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3)~Fleet Enema: hyper-osmolar preparation~tap water enema: hypo-osmolar preparation~Normosol-R enema: iso-osmolar preparation"
1049907|NCT00696618|P3|Participant Flow|Fleet/Tap Water/Normosol-R|"Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 2), Followed by Normosol-R enema(iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3)~Fleet Enema: hyper-osmolar preparation~tap water enema: hypo-osmolar preparation~Normosol-R enema: iso-osmolar preparation"
1049908|NCT00696618|P2|Participant Flow|Normosol-R/Fleet/Tap Water|"Normosol-R enema (iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 2), Followed by Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3)~Fleet Enema: hyper-osmolar preparation~tap water enema: hypo-osmolar preparation~Normosol-R enema: iso-osmolar preparation"
1049909|NCT00696618|P1|Participant Flow|Tap Water/Normosol-R/Fleet|"Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Normosol-R enema (iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home(Stage 2), Followed by Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3)~Fleet Enema: hyper-osmolar preparation~tap water enema: hypo-osmolar preparation~Normosol-R enema: iso-osmolar preparation"
1049910|NCT00696618|O3|Outcome|Hyper-osmolar Enema|Fleet Hyper-osmolar enema
1049911|NCT00696618|O2|Outcome|Iso-osmolar Enema|Normosol-R Iso-osmolar enema
1049912|NCT00696618|O1|Outcome|Hypo-osmolar Enema|Hypo-osmolar Tap water enema
1049913|NCT00696618|O3|Outcome|Hyper-osmolar Enema|Fleet Hyper-osmolar enema
1049914|NCT00696618|O2|Outcome|Iso-osmolar Enema|Normosol-R Iso-osmolar enema
1049915|NCT00696618|O1|Outcome|Hypo-osmolar Enema|Hypo-osmolar Tap water enema
1049916|NCT00696618|O3|Outcome|Hyper-osmolar Enema|Fleet Hyper-osmolar enema
1049917|NCT00696618|O2|Outcome|Iso-osmolar Enema|Normosol-R Iso-osmolar enema
1049918|NCT00696618|O1|Outcome|Hypo-osmolar Enema|Hypo-osmolar Tap water enema
1049922|NCT00696488|B1|Baseline|Fluorouracil 0.5%|"each subject will receive the study medication: Carac® 0.5% Fluorouracil, a standard treatment for actinic keratoses. Carac® will be dispensed to the subjects in the original tube with MEMS electronic monitoring caps attached. Subjects will be asked to apply the medication daily to AK lesions~Fluorouracil 0.5%: Subjects will apply the smallest amount of study medication possible that is just sufficient to cover all of the affected areas daily to AK lesions"
1049923|NCT00696488|P1|Participant Flow|Fluorouracil 0.5%|"each subject will receive the study medication: Carac® 0.5% Fluorouracil, a standard treatment for actinic keratoses. Carac® will be dispensed to the subjects in the original tube with MEMS electronic monitoring caps attached. Subjects will be asked to apply the medication daily to AK lesions~Fluorouracil 0.5%: Subjects will apply the smallest amount of study medication possible that is just sufficient to cover all of the affected areas daily to AK lesions"
1049924|NCT00696488|O1|Outcome|Fluorouracil 0.5%|"each subject will receive the study medication: Carac® 0.5% Fluorouracil, a standard treatment for actinic keratoses. Carac® will be dispensed to the subjects in the original tube with MEMS electronic monitoring caps attached. Subjects will be asked to apply the medication daily to AK lesions~Fluorouracil 0.5%: Subjects will apply the smallest amount of study medication possible that is just sufficient to cover all of the affected areas daily to AK lesions"
1049925|NCT00696488|E1|Reported Event|Fluorouracil 0.5%|"each subject will receive the study medication: Carac® 0.5% Fluorouracil, a standard treatment for actinic keratoses. Carac® will be dispensed to the subjects in the original tube with MEMS electronic monitoring caps attached. Subjects will be asked to apply the medication daily to AK lesions~Fluorouracil 0.5%: Subjects will apply the smallest amount of study medication possible that is just sufficient to cover all of the affected areas daily to AK lesions"
1049926|NCT00696449|B5|Baseline|Total|Total of all reporting groups
1049927|NCT00696449|B4|Baseline|Standard of Care Control|"This group is considered to be the standard of care arm and will return to the study center for study visits on Weeks 6 and 12. This group will not receive any kind of reminders other than the instructions provided by the study staff during the study visits."
1049928|NCT00696449|B3|Baseline|Parental Reminders|In this group parents will be prompted by a daily electronic message by email, text pager, or phone message (approximately at the same time each day) to remind the Subject to use the study medication within a 4-hour window after the reminder. Parents will be instructed to then verbally deliver the message to the study Subject. Subjects will return to the study center for study visits on Weeks 6 and 12.
1049929|NCT00696449|B2|Baseline|Electronic Reminders|This group will receive a daily electronic reminder by email, text pager, or phone message (approximately at the same time each day) to use the study medication within a 4-hour window after the reminder and will return to the study center for study visits on Weeks 6 and 12.
1049930|NCT00696449|B1|Baseline|Frequent Office Visits|This group will be asked to return to the study center on weeks 1, 2, 4 and 8 for office visits (to remind the Subject to apply the study medication); in addition to the study visits on Weeks 6 and 12.
1049931|NCT00696449|P4|Participant Flow|Standard of Care Control|"This group is considered to be the standard of care arm and will return to the study center for study visits on Weeks 6 and 12. This group will not receive any kind of reminders other than the instructions provided by the study staff during the study visits."
1049932|NCT00696449|P3|Participant Flow|Parental Reminders|In this group parents will be prompted by a daily electronic message by email, text pager, or phone message (approximately at the same time each day) to remind the Subject to use the study medication within a 4-hour window after the reminder. Parents will be instructed to then verbally deliver the message to the study Subject. Subjects will return to the study center for study visits on Weeks 6 and 12.
1049933|NCT00696449|P2|Participant Flow|Electronic Reminders|This group will receive a daily electronic reminder by email, text pager, or phone message (approximately at the same time each day) to use the study medication within a 4-hour window after the reminder and will return to the study center for study visits on Weeks 6 and 12.
1049934|NCT00696449|P1|Participant Flow|Frequent Office Visits|This group will be asked to return to the study center on weeks 1, 2, 4 and 8 for office visits (to remind the Subject to apply the study medication); in addition to the study visits on Weeks 6 and 12.
1049935|NCT00696449|O4|Outcome|Standard of Care Control|"This group is considered to be the standard of care arm and will return to the study center for study visits on Weeks 6 and 12. This group will not receive any kind of reminders other than the instructions provided by the study staff during the study visits."
1049936|NCT00696449|O3|Outcome|Parental Reminders|In this group parents will be prompted by a daily electronic message by email, text pager, or phone message (approximately at the same time each day) to remind the Subject to use the study medication within a 4-hour window after the reminder. Parents will be instructed to then verbally deliver the message to the study Subject. Subjects will return to the study center for study visits on Weeks 6 and 12.
1049937|NCT00696449|O2|Outcome|Electronic Reminders|This group will receive a daily electronic reminder by email, text pager, or phone message (approximately at the same time each day) to use the study medication within a 4-hour window after the reminder and will return to the study center for study visits on Weeks 6 and 12.
1049938|NCT00696449|O1|Outcome|Frequent Office Visits|This group will be asked to return to the study center on weeks 1, 2, 4 and 8 for office visits (to remind the Subject to apply the study medication); in addition to the study visits on Weeks 6 and 12.
1049939|NCT00696449|E4|Reported Event|Standard of Care Control|"This group is considered to be the standard of care arm and will return to the study center for study visits on Weeks 6 and 12. This group will not receive any kind of reminders other than the instructions provided by the study staff during the study visits."
1049940|NCT00696449|E3|Reported Event|Parental Reminders|In this group parents will be prompted by a daily electronic message by email, text pager, or phone message (approximately at the same time each day) to remind the Subject to use the study medication within a 4-hour window after the reminder. Parents will be instructed to then verbally deliver the message to the study Subject. Subjects will return to the study center for study visits on Weeks 6 and 12.
1049941|NCT00696449|E2|Reported Event|Electronic Reminders|This group will receive a daily electronic reminder by email, text pager, or phone message (approximately at the same time each day) to use the study medication within a 4-hour window after the reminder and will return to the study center for study visits on Weeks 6 and 12.
1050089|NCT00696241|B5|Baseline|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
1049942|NCT00696449|E1|Reported Event|Frequent Office Visits|This group will be asked to return to the study center on weeks 1, 2, 4 and 8 for office visits (to remind the Subject to apply the study medication); in addition to the study visits on Weeks 6 and 12.
1049943|NCT00696436|B6|Baseline|Total|Total of all reporting groups
1049944|NCT00696436|B5|Baseline|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
1049945|NCT00696436|B4|Baseline|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
1049946|NCT00696436|B3|Baseline|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
1049947|NCT00696436|B2|Baseline|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
1049948|NCT00696436|B1|Baseline|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
1049949|NCT00696436|P5|Participant Flow|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
1049950|NCT00696436|P4|Participant Flow|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
1049951|NCT00696436|P3|Participant Flow|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
1049952|NCT00696436|P2|Participant Flow|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
1049953|NCT00696436|P1|Participant Flow|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
1049954|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
1049955|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
1049956|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
1049957|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
1049958|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
1049959|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
1049960|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
1049961|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
1049962|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
1049963|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
1049964|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
1049965|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
1049966|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
1049967|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
1049968|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
1049969|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
1049970|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
1049971|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
1050090|NCT00696241|B4|Baseline|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
1050091|NCT00696241|B3|Baseline|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1049972|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
1049973|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
1049974|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
1049975|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
1049976|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
1049977|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
1049978|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
1049979|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
1049980|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
1049981|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
1049982|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
1049983|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
1049984|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
1049985|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
1049986|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
1049987|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
1049988|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
1049989|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
1049990|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
1049991|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
1049992|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
1049993|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
1049994|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
1049995|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
1049996|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
1049997|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
1049998|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
1049999|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
1050000|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
1050001|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
1057121|NCT00675792|O1|Outcome|Sugammadex|4 mg/kg sugammadex
1050002|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
1050003|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
1050004|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
1050005|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
1050006|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
1050007|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
1050008|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
1050009|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
1050010|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
1050011|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
1050012|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
1050013|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
1050014|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
1050015|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
1050016|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
1050017|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
1050018|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
1050019|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
1050020|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
1050021|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
1050022|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
1050023|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
1050024|NCT00696436|O5|Outcome|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
1050025|NCT00696436|O4|Outcome|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
1050026|NCT00696436|O3|Outcome|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
1050027|NCT00696436|O2|Outcome|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
1050028|NCT00696436|O1|Outcome|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
1050029|NCT00696436|E5|Reported Event|Placebo QD|Matching placebo, orally, once daily for up to six weeks.
1050030|NCT00696436|E4|Reported Event|Olmesartan 40 mg QD|"Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.~Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks."
1050031|NCT00696436|E3|Reported Event|Valsartan 320 mg QD|"Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.~Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks."
1057122|NCT00675792|O2|Outcome|Neostigmine|50 µg/kg neostigmine
1050032|NCT00696436|E2|Reported Event|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.~Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks."
1050033|NCT00696436|E1|Reported Event|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.~Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks."
1050034|NCT00696423|B3|Baseline|Total|Total of all reporting groups
1050035|NCT00696423|B2|Baseline|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
1050036|NCT00696423|B1|Baseline|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
1050037|NCT00696423|P2|Participant Flow|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
1050038|NCT00696423|P1|Participant Flow|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
1050039|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
1050040|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
1050041|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
1050042|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
1050043|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
1050044|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
1050045|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
1050046|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
1050047|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
1050048|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
1050049|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
1050050|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
1050051|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
1050052|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
1050053|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
1050054|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
1050055|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
1050056|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
1050057|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
1050058|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
1050059|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
1050060|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
1050061|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
1050062|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
1050063|NCT00696423|O2|Outcome|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
1050064|NCT00696423|O1|Outcome|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
1050065|NCT00696423|E2|Reported Event|Infanrix + Hiberix Separate Injection Group|Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
1050066|NCT00696423|E1|Reported Event|Infanrix/Hib Single Injection Group|Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
1050067|NCT00696384|B1|Baseline|Azilsartan Medoxomil QD - Open Label Phase|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, titrated to 80 mg, tablets, orally, once daily. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily as needed and other antihypertensive medications as needed to achieve target blood pressure (defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and <130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks. Study medication could have been up-titrated only after participant had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up or down-titrated by 1 dose level per scheduled or unscheduled visit. Baseline characteristics of this Open Label phase population are described in the table below.
1050068|NCT00696384|P3|Participant Flow|Placebo QD - Double-Blind Reversal Phase|Azilsartan medoxomil placebo-matching tablets, orally, once daily with or without chlorthalidone 25 mg, orally once daily or other non-ARB antihypertensive (if currently taking), tablets, orally, once daily for 6 weeks.
1050069|NCT00696384|P2|Participant Flow|Azilsartan Medoxomil QD - Double-Blind Reversal Phase|Azilsartan medoxomil at the final dose received during the open-label phase: (20 mg, 40 mg or 80 mg), tablets, orally, once daily with or without chlorthalidone 25 mg, tablets, orally once daily and other non-ARB antihypertensive medications (if currently taking), for 6 weeks.
1050070|NCT00696384|P1|Participant Flow|Azilsartan Medoxomil QD - Open Label Phase|"All subjects initiated azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, force-titrated to 80 mg, tablets, orally, once daily. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily was added as needed, followed by other non-ARB antihypertensive medications as needed to achieve target blood pressure (defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and <130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks.~Study medication could have been up-titrated only after the subject had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up- or down-titrated by 1 dose level per scheduled or unscheduled visit."
1050071|NCT00696384|O2|Outcome|Placebo QD - Double Blind Reversal Phase|Azilsartan medoxomil placebo-matching tablets, orally, once daily with or without chlorthalidone 25 mg or other antihypertensive (if currently taking), tablets, orally, once daily for 6 weeks.
1050072|NCT00696384|O1|Outcome|Azilsartan Medoxomil QD - Double Blind Reversal Phase|Azilsartan medoxomil at the final dose received during the open-label phase: (20 mg, 40 mg or 80 mg), tablets, orally, once daily with or without chlorthalidone 25 mg, tablets, orally once daily and other non-ARB antihypertensive medications (if currently taking) as needed for 6 weeks.
1050073|NCT00696384|O1|Outcome|Azilsartan Medoxomil QD - Open Label Phase|"All subjects initiated azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, force-titrated to 80 mg, tablets, orally, once daily. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily was added as needed and other non-ARB antihypertensive medications as needed to achieve target blood pressure (defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and <130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks.~Study medication could have been up-titrated only after the subject had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up- or down-titrated by 1 dose level per scheduled or unscheduled visit."
1050074|NCT00696384|O1|Outcome|Azilsartan Medoxomil QD - Open Label Phase|"All subjects initiated azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, force-titrated to 80 mg, tablets, orally, once daily. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily was added as needed, followed by other non-ARB antihypertensive medications as needed to achieve target blood pressure (defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and <130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks.~Study medication could have been up-titrated only after the subject had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up- or down-titrated by 1 dose level per scheduled or unscheduled visit."
1050075|NCT00696384|O1|Outcome|Azilsartan Medoxomil QD - Open Label Phase|"All subjects initiated azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, force-titrated to 80 mg, tablets, orally, once daily. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily was added as needed, followed by other non-ARB antihypertensive medications as needed to achieve target blood pressure (defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and <130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks.~Study medication could have been up-titrated only after the subject had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up- or down-titrated by 1 dose level per scheduled or unscheduled visit."
1050076|NCT00696384|O2|Outcome|Placebo QD - Double Blind Reversal Phase|Azilsartan medoxomil placebo-matching tablets, orally, once daily with or without chlorthalidone 25 mg or other antihypertensive (if currently taking), tablets, orally, once daily for 6 weeks.
1050077|NCT00696384|O1|Outcome|Azilsartan Medoxomil QD - Double Blind Reversal Phase|Azilsartan medoxomil at the final dose received during the open-label phase: (20 mg, 40 mg or 80 mg), tablets, orally, once daily with or without chlorthalidone 25 mg, tablets, orally once daily and other non-ARB antihypertensive medications (if currently taking) as needed for 6 weeks.
1050078|NCT00696384|O2|Outcome|Placebo QD - Double Blind Reversal Phase|Azilsartan medoxomil placebo-matching tablets, orally, once daily with or without chlorthalidone 25 mg or other antihypertensive (if currently taking), tablets, orally, once daily for 6 weeks.
1050079|NCT00696384|O1|Outcome|Azilsartan Medoxomil QD - Double Blind Reversal Phase|Azilsartan medoxomil at the final dose received during the open-label phase: (20 mg, 40 mg or 80 mg), tablets, orally, once daily with or without chlorthalidone 25 mg, tablets, orally once daily and other non-ARB antihypertensive medications (if currently taking) as needed for 6 weeks.
1050080|NCT00696384|E3|Reported Event|Placebo QD - Double-Blind Reversal Phase|Azilsartan medoxomil placebo-matching tablets, orally, once daily with or without chlorthalidone 25 mg or other antihypertensive (if currently taking), tablets, orally, once daily for up to 6 weeks.
1050081|NCT00696384|E2|Reported Event|Azilsartan Medoxomil QD - Double-Blind Reversal Phase|Azilsartan medoxomil current dose (20 mg, 40 mg or 80 mg), tablets, orally, once daily with or without chlorthalidone 25 mg, tablets, orally once daily and other antihypertensive medications as needed for 6 weeks.
1050082|NCT00696384|E1|Reported Event|Azilsartan Medoxomil QD - Open Label|"Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks, titrated to 80 mg, tablets, orally, once daily.. After Week 8, chlorthalidone, 25 mg, tablets, orally, once daily as needed and other antihypertensive medications as needed to achieve target blood pressure (defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) and <130/80 mm Hg for participants with diabetes or CKD) for up to 26 weeks.~Study medication could have been up-titrated only after the subject had been at the previous dose level for a minimum of 2 weeks. Study medication could only have been up- or down-titrated by 1 dose level per scheduled or unscheduled visit."
1050083|NCT00696293|B1|Baseline|Duloxetine Plus Clinical Management|"Duloxetine + clinical management~Duloxetine: Duloxetine up to 120 mg/day + Clinical Management"
1050084|NCT00696293|P1|Participant Flow|Duloxetine Plus Clinical Management|"Duloxetine + clinical management~Duloxetine: Duloxetine up to 120 mg/day + Clinical Management"
1050085|NCT00696293|O1|Outcome|Duloxetine + Clinical Management|"Duloxetine + clinical management~NOTE -- THIS WORK WAS CONDUCTED AS PART OF A CAREER DEVELOPMENT AWARD. THE CLINICALTRIALS.GOV DESCRIPTION OF THE STUDY WAS UPDATED 1/5/16 TO UPDATE THE OPEN LABEL NATURE OF THIS WORK. THIS IS WHAT IS REPORTED HERE AND HAS BEEN PEER REVIEWED AND PUBLISHED.~Duloxetine: Duloxetine up to 120 mg/day + Clinical Management"
1050086|NCT00696293|O1|Outcome|Duloxetine Plus Clinical Management|"Duloxetine + clinical management~Duloxetine: Duloxetine up to 120 mg/day + Clinical Management"
1050087|NCT00696293|E1|Reported Event|Duloxetine Plus Clinical Management|"Duloxetine + clinical management~Duloxetine: Duloxetine up to 120 mg/day + Clinical Management"
1050092|NCT00696241|B2|Baseline|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1050093|NCT00696241|B1|Baseline|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
1050094|NCT00696241|P5|Participant Flow|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
1050095|NCT00696241|P4|Participant Flow|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
1050096|NCT00696241|P3|Participant Flow|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1050097|NCT00696241|P2|Participant Flow|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1050098|NCT00696241|P1|Participant Flow|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
1050099|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
1050100|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
1050101|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1050102|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1050103|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
1050104|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
1050105|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
1050106|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1050107|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1050108|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
1050109|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
1050110|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
1050111|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1050112|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1050113|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
1050114|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
1050115|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
1050116|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1050117|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1050118|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
1050119|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
1050120|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
1050121|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1050122|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1050123|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
1050124|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
1050125|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
1050126|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1050127|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1050128|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
1050129|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
1050130|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
1050131|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1050132|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1050133|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
1050134|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
1050135|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
1050136|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1050137|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1050138|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
1050139|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
1050140|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
1050141|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1050142|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1050143|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
1050144|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
1050145|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
1050146|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1050147|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1050148|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
1050149|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
1050150|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
1050151|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1050152|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1050153|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
1050154|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
1050155|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
1050156|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1050157|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1050158|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
1050159|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
1050160|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
1050161|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1050162|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1050163|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
1050164|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
1050165|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
1050166|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1050167|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1050168|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
1050169|NCT00696241|O5|Outcome|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
1050170|NCT00696241|O4|Outcome|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
1050171|NCT00696241|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1050172|NCT00696241|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1050173|NCT00696241|O1|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
1050174|NCT00696241|E5|Reported Event|Placebo QD|Placebo-matching tablets, orally, once daily for up to 6 weeks.
1050175|NCT00696241|E4|Reported Event|Olmesartan 40 mg QD|Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
1050176|NCT00696241|E3|Reported Event|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1050177|NCT00696241|E2|Reported Event|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1050178|NCT00696241|E1|Reported Event|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
1050179|NCT00696072|B3|Baseline|Total|Total of all reporting groups
1050180|NCT00696072|B2|Baseline|Letrozole|Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years
1050181|NCT00696072|B1|Baseline|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years~Dasatinib 100 mg + Letrozole 2.5 mg"
1050182|NCT00696072|P2|Participant Flow|Letrozole|Participants received letrozole 2.5 mg tablets, once daily, up to 2 years. If the participant developed progressive disease while on the single agent, the participant had the option to add dasatinib to their treatment regimen.
1050183|NCT00696072|P1|Participant Flow|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years~Dasatinib 100 mg + Letrozole 2.5 mg Tablets, once daily up to 2 years. If a participant experienced intolerable toxicity related to dasatinib, they had the option to crossover to letrozole arm."
1050184|NCT00696072|O2|Outcome|Letrozole|"Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years~Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days"
1050185|NCT00696072|O1|Outcome|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years~Dasatinib 100 mg + Letrozole 2.5 mg~Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days"
1050186|NCT00696072|O2|Outcome|Letrozole|"Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years~Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days"
1050187|NCT00696072|O1|Outcome|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years~Dasatinib 100 mg + Letrozole 2.5 mg~Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days"
1050430|NCT00695565|P1|Participant Flow|Placebo Gel|Placebo Gel is vehicle without clonidine
1050188|NCT00696072|O2|Outcome|Letrozole|"Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years~Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days"
1050189|NCT00696072|O1|Outcome|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years~Dasatinib 100 mg + Letrozole 2.5 mg~Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days"
1050190|NCT00696072|O1|Outcome|Crossed Over From Letrozole to Letrozole + Dasatinib|These participants were randomized to receive letrozole 2.5 mg PO once daily. After developing progressive disease they continued letrozole, and were permitted to add 100 mg PO once daily dasatinib to their treatment regimen.
1050191|NCT00696072|O2|Outcome|Letrozole|"Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years~Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days"
1050192|NCT00696072|O1|Outcome|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years~Dasatinib 100 mg + Letrozole 2.5 mg~Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days"
1050193|NCT00696072|O2|Outcome|Letrozole|"Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years~Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days"
1050194|NCT00696072|O1|Outcome|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years~Dasatinib 100 mg + Letrozole 2.5 mg~Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days"
1050195|NCT00696072|O2|Outcome|Letrozole|"Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years~Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days"
1050196|NCT00696072|O1|Outcome|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years~Dasatinib 100 mg + Letrozole 2.5 mg~Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days"
1050197|NCT00696072|E2|Reported Event|Letrozole|Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years
1050198|NCT00696072|E1|Reported Event|Dasatinib Plus Letrozole|"Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years~Dasatinib 100 mg + Letrozole 2.5 mg"
1050199|NCT00696020|B5|Baseline|Total|Total of all reporting groups
1050200|NCT00696020|B4|Baseline|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050201|NCT00696020|B3|Baseline|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050202|NCT00696020|B2|Baseline|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050203|NCT00696020|B1|Baseline|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050204|NCT00696020|P4|Participant Flow|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050205|NCT00696020|P3|Participant Flow|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050206|NCT00696020|P2|Participant Flow|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050207|NCT00696020|P1|Participant Flow|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050208|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050209|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050210|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050211|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050212|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050213|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050214|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050215|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050216|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050217|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050218|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050219|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050220|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050221|NCT00696020|O1|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050222|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050223|NCT00696020|O1|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050224|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050225|NCT00696020|O1|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050226|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050227|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050228|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050229|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050230|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050231|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050232|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050233|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050234|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050235|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050236|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050237|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050238|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050239|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050240|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050241|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050242|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050243|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050244|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050245|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050246|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050247|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050248|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050249|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050250|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050251|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050252|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050253|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050254|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050255|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050256|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050257|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050258|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050259|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050260|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050261|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050262|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050263|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050264|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050265|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050266|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050267|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050268|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050269|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050270|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050271|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050482|NCT00695435|O2|Outcome|TOBREX® Ophthalmic Solution|TOBREX® Ophthalmic Solution
1050272|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050273|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050274|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050275|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050276|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050277|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050278|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050279|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050280|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050281|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050282|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050283|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050284|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050285|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050286|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050287|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050288|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050289|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050290|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050291|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050292|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050293|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050294|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050295|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050296|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050297|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050298|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050299|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050300|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050742|NCT00694122|E2|Reported Event|Lantus Insulin|Individuals on Lantus insulin as long acting insulin.
1050301|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050302|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050303|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050304|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050305|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050306|NCT00696020|O4|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050307|NCT00696020|O3|Outcome|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050308|NCT00696020|O2|Outcome|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050309|NCT00696020|O1|Outcome|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050310|NCT00696020|E4|Reported Event|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050311|NCT00696020|E3|Reported Event|Tiotropium+Olodaterol 5/5 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050312|NCT00696020|E2|Reported Event|Tiotropium+Olodaterol 5/2 μg|Oral inhalation of FDC of Tiotropium 5 µg and Olodaterol 2 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 1.0 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050313|NCT00696020|E1|Reported Event|5 µg Tiotropium|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
1050314|NCT00695955|B1|Baseline|Azilsartan Medoxomil|"Cohort 1: Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.~Cohort 2: Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved."
1050315|NCT00695955|P1|Participant Flow|Azilsartan Medoxomil|"Cohort 1: Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.~Cohort 2: Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved."
1050316|NCT00695955|O1|Outcome|Cohort 2|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved.
1050317|NCT00695955|O1|Outcome|Cohort 1|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
1050318|NCT00695955|O1|Outcome|Cohort 2|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved.
1050319|NCT00695955|O1|Outcome|Cohort 1|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
1050320|NCT00695955|O1|Outcome|Cohort 2|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved.
1050321|NCT00695955|O1|Outcome|Cohort 1|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
1050322|NCT00695955|E2|Reported Event|Cohort 2|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved.
1050743|NCT00694122|E1|Reported Event|NPH Insulin|Individuals on NPH insuling as long acting insulin.
1050323|NCT00695955|E1|Reported Event|Cohort 1|Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
1050324|NCT00695903|B3|Baseline|Total|Total of all reporting groups
1050325|NCT00695903|B2|Baseline|Vancomycin High-dose|Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL
1050326|NCT00695903|B1|Baseline|Daptomycin 10 mg/kg|Daptomycin 10 mg/kg Intravenously (IV) every 24 hours
1050327|NCT00695903|P2|Participant Flow|Vancomycin High-dose|Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL
1050328|NCT00695903|P1|Participant Flow|Daptomycin 10 mg/kg|Daptomycin 10 mg/kg Intravenously (IV) every 24 hours
1050329|NCT00695903|O2|Outcome|Vancomycin High-dose|Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL
1050330|NCT00695903|O1|Outcome|Daptomycin 10 mg/kg|Daptomycin 10 mg/kg Intravenously (IV) every 24 hours
1050331|NCT00695903|O2|Outcome|Vancomycin High-dose|Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL
1050332|NCT00695903|O1|Outcome|Daptomycin 10 mg/kg|Daptomycin 10 mg/kg Intravenously (IV) every 24 hours
1050333|NCT00695903|O2|Outcome|Vancomycin High-dose|Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL
1050334|NCT00695903|O1|Outcome|Daptomycin 10 mg/kg|Daptomycin 10 mg/kg Intravenously (IV) every 24 hours
1050335|NCT00695903|O2|Outcome|Vancomycin High-dose|Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL
1050336|NCT00695903|O1|Outcome|Daptomycin 10 mg/kg|Daptomycin 10 mg/kg Intravenously (IV) every 24 hours
1050337|NCT00695903|E2|Reported Event|Vancomycin|Vancomycin 15 mg/kg i.v., dosed to maintain trough serum concentrations of 15 to 20 ug/mL
1050338|NCT00695903|E1|Reported Event|Daptomycin|Daptomycin 10 mg/kg i.v.q24hr
1050339|NCT00695864|B1|Baseline|Placebo Then Ondansetron|"Dosage and form:~Placebo - tablet Odansetron - 8 mg oral tablet~Double-blind, placebo-controlled, cross-over trial. All participants received placebo first, followed by Ondansetron."
1050340|NCT00695864|P1|Participant Flow|Placebo Then Ondansetron|"Dosage and form:~Placebo - tablet Odansetron - 8 mg oral tablet~Double-blind, placebo-controlled, cross-over trial. All participants received placebo first, followed by Ondansetron."
1050341|NCT00695864|O2|Outcome|Ondansetron|"Ondansetron~Ondansetron and Placebo crossover"
1050342|NCT00695864|O1|Outcome|Placebo - Sugar Pill|"Placebo - sugar pill~Ondansetron and Placebo crossover"
1050343|NCT00695864|E2|Reported Event|Ondansetron|"Ondansetron~Ondansetron and Placebo crossover"
1050344|NCT00695864|E1|Reported Event|Placebo - Sugar Pill|"Placebo - sugar pill~Ondansetron and Placebo crossover"
1050345|NCT00695669|B5|Baseline|Total|Total of all reporting groups
1050346|NCT00695669|B4|Baseline|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050347|NCT00695669|B3|Baseline|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050348|NCT00695669|B2|Baseline|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050349|NCT00695669|B1|Baseline|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050350|NCT00695669|P4|Participant Flow|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050351|NCT00695669|P3|Participant Flow|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050352|NCT00695669|P2|Participant Flow|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050353|NCT00695669|P1|Participant Flow|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050354|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050355|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050356|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050357|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050431|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
1050358|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050359|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050360|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050361|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050362|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050363|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050364|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050365|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050366|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050367|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050368|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050369|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050370|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050371|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050372|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050373|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050374|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050375|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050376|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050377|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050378|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050379|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050380|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050432|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
1050381|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050382|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050383|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050384|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050385|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050386|NCT00695669|O1|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050387|NCT00695669|O1|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050388|NCT00695669|O1|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050389|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050390|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050391|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050392|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050393|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050394|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050395|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050396|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050397|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050398|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050399|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050400|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050401|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050402|NCT00695669|O1|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050403|NCT00695669|O1|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050433|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
1050404|NCT00695669|O1|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050405|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050406|NCT00695669|O1|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050407|NCT00695669|O1|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050408|NCT00695669|O1|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050409|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050410|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050411|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050412|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050413|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050414|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050415|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050416|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050417|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050418|NCT00695669|O4|Outcome|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050419|NCT00695669|O3|Outcome|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050420|NCT00695669|O2|Outcome|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050421|NCT00695669|O1|Outcome|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050422|NCT00695669|E4|Reported Event|Influenza A (H5N1) 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050423|NCT00695669|E3|Reported Event|Influenza A (H5N1) 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050424|NCT00695669|E2|Reported Event|Influenza A (H5N1) 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050425|NCT00695669|E1|Reported Event|Influenza A (H5N1) 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
1050426|NCT00695565|B3|Baseline|Total|Total of all reporting groups
1050427|NCT00695565|B2|Baseline|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride
1050428|NCT00695565|B1|Baseline|Placebo Gel|Placebo Gel is vehicle without clonidine
1050429|NCT00695565|P2|Participant Flow|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride
1050434|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
1050435|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
1050436|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
1050437|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
1050438|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
1050439|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
1050440|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
1050441|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
1050442|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
1050443|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
1050444|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
1050445|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
1050446|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
1050447|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
1050448|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
1050449|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
1050450|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
1050451|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
1050452|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
1050453|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
1050454|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
1050455|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
1050456|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
1050457|NCT00695565|O2|Outcome|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride; Subjects applied the gel to their feet 3 times daily starting on Day 1.
1050458|NCT00695565|O1|Outcome|Placebo Gel|Placebo Gel is vehicle without clonidine; Subjects applied the gel to their feet 3 times daily starting on Day 1.
1050459|NCT00695565|E2|Reported Event|Clonidine Topical Gel (ARC-4558)|Clonidine Topical Gel contains 0.1% clonidine hydrochloride
1050460|NCT00695565|E1|Reported Event|Placebo Gel|Placebo Gel is vehicle without clonidine
1050461|NCT00695500|B3|Baseline|Total|Total of all reporting groups
1050462|NCT00695500|B2|Baseline|Placebo|Placebo tablets, 0 mg per day for 3 weeks
1050463|NCT00695500|B1|Baseline|Varenicline|Varenicline tablets, 2 mg per day for 3 weeks
1050464|NCT00695500|P2|Participant Flow|Placebo|Placebo tablets, 0 mg per day for 3 weeks
1050465|NCT00695500|P1|Participant Flow|Varenicline|Varenicline tablets, 2 mg per day for 3 weeks
1050466|NCT00695500|O2|Outcome|Placebo|Placebo tablets, 0 mg per day for 3 weeks
1050467|NCT00695500|O1|Outcome|Varenicline|Varenicline tablets, 2 mg per day for 3 weeks
1050468|NCT00695500|O2|Outcome|Placebo|Placebo tablets, 0 mg per day for 3 weeks
1050469|NCT00695500|O1|Outcome|Varenicline|Varenicline tablets, 2 mg per day for 3 weeks
1050470|NCT00695500|O2|Outcome|Placebo|Placebo tablets, 0 mg per day for 3 weeks
1050471|NCT00695500|O1|Outcome|Varenicline|Varenicline tablets, 2 mg per day for 3 weeks
1050472|NCT00695500|E2|Reported Event|Placebo|Placebo tablets, 0 mg per day for 3 weeks
1050473|NCT00695500|E1|Reported Event|Varenicline|Varenicline tablets, 2 mg per day for 3 weeks
1050474|NCT00695435|B1|Baseline|Overall Study|Overall Study
1050475|NCT00695435|P3|Participant Flow|TOBREX, Then TOBRADEX, Then Tob 0.3%/Dex 0.05%|Patients received TOBREX first, then TOBRADEX, then Tob 0.3%/Dex 0.05%
1050476|NCT00695435|P2|Participant Flow|Tob 0.3%/Dex 0.05%, Then TOBREX, Then TOBRADEX|Patients received Tob 0.3%/Dex 0.05% first, then TOBREX, then TOBRADEX
1050477|NCT00695435|P1|Participant Flow|TOBRADEX, Then Tob 0.3%/Dex 0.05%, Then TOBREX|Patients received TOBRADEX first, then Tob 0.3%/Dex 0.05%, then TOBREX
1050478|NCT00695435|O3|Outcome|TOBRADEX® Ophthalmic Suspension|TOBRADEX® Ophthalmic Suspension
1050479|NCT00695435|O2|Outcome|TOBREX® Ophthalmic Solution|TOBREX® Ophthalmic Solution
1050480|NCT00695435|O1|Outcome|Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension|Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
1050481|NCT00695435|O3|Outcome|TOBRADEX® Ophthalmic Suspension|TOBRADEX® Ophthalmic Suspension
1050483|NCT00695435|O1|Outcome|Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension|Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
1050484|NCT00695435|E3|Reported Event|TOBRADEX®|TOBRADEX® Ophthalmic Suspension
1050485|NCT00695435|E2|Reported Event|TOBREX®|TOBREX® Ophthalmic Solution
1050486|NCT00695435|E1|Reported Event|Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension|Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension
1050487|NCT00695396|B4|Baseline|Total|Total of all reporting groups
1050488|NCT00695396|B3|Baseline|Epoetin Alfa 80000 IU|(2 mL) subcutaneously once every week
1050489|NCT00695396|B2|Baseline|Epoetin Alfa 40000 IU|(1 mL) subcutaneously once every week
1050490|NCT00695396|B1|Baseline|Placebo|(1ml or 2 mL) subcutaneously once every week
1050491|NCT00695396|P3|Participant Flow|Epoetin Alfa 80000 IU|(2 mL) subcutaneously once every week
1050492|NCT00695396|P2|Participant Flow|Epoetin Alfa 40000 IU|(1 mL) subcutaneously once every week
1050493|NCT00695396|P1|Participant Flow|Placebo|(1ml or 2 mL) subcutaneously once every week
1050494|NCT00695396|O3|Outcome|Epoetin Alfa 80000 IU|(2 mL) subcutaneously once every week
1050495|NCT00695396|O2|Outcome|Epoetin Alfa 40000 IU|(1 mL) subcutaneously once every week
1050496|NCT00695396|O1|Outcome|Placebo|(1ml or 2 mL) subcutaneously once every week
1050497|NCT00695396|O3|Outcome|Epoetin Alfa 80000 IU|(2 mL) subcutaneously once every week
1050498|NCT00695396|O2|Outcome|Epoetin Alfa 40000 IU|(1 mL) subcutaneously once every week
1050499|NCT00695396|O1|Outcome|Placebo|(1ml or 2 mL) subcutaneously once every week
1050500|NCT00695396|O3|Outcome|Epoetin Alfa 80000 IU|(2 mL) subcutaneously once every week
1050501|NCT00695396|O2|Outcome|Epoetin Alfa 40000 IU|(1 mL) subcutaneously once every week
1050502|NCT00695396|O1|Outcome|Placebo|(1ml or 2 mL) subcutaneously once every week
1050503|NCT00695396|E3|Reported Event|Epoetin Alfa 80000 IU|(2 mL) subcutaneously once every week
1050504|NCT00695396|E2|Reported Event|Epoetin Alfa 40000 IU|(1 mL) subcutaneously once every week
1050505|NCT00695396|E1|Reported Event|Placebo|(1ml or 2 mL) subcutaneously once every week
1050506|NCT00695318|B3|Baseline|Total|Total of all reporting groups
1050507|NCT00695318|B2|Baseline|A, 2, II 0.5 µg/Day + Sham|"0.5 µg/Day~Fluocinolone Acetonide: 0.5 µg/Day + Sham treatment in fellow eye"
1050508|NCT00695318|B1|Baseline|A, 2, I 0.2 µg/Day + Sham|"0.2 µg/Day~Fluocinolone Acetonide: 0.2 µg/Day + Sham treatment in fellow eye"
1050509|NCT00695318|P2|Participant Flow|A, 2, II 0.5 µg/Day + Sham|"0.5 µg/Day~Fluocinolone Acetonide: 0.5 µg/Day"
1050510|NCT00695318|P1|Participant Flow|A, 2, I 0.2 µg/Day + Sham|"0.2 µg/Day~Fluocinolone Acetonide: 0.2 µg/Day"
1050511|NCT00695318|O4|Outcome|A, 2, II 0.5 µg/Day|"0.5 µg/Day~Fluocinolone Acetonide: 0.5 µg/Day"
1050512|NCT00695318|O3|Outcome|A, 2, II Sham|
1050513|NCT00695318|O2|Outcome|A, 2, I 0.2 µg/Day|"0.2 µg/Day~Fluocinolone Acetonide: 0.2 µg/Day"
1050514|NCT00695318|O1|Outcome|A, 2, I Sham|
1050515|NCT00695318|E5|Reported Event|0.5 ug/Day + Sham Injection|"Fluocinolone Acetonide: 0.5 µg/Day + Sham Injection~Systemic AEs"
1050516|NCT00695318|E4|Reported Event|0.2 ug/Day + Sham Injection|"Fluocinolone Acetonide: 0.2 µg/Day + Sham Injection~Systemic AEs"
1050517|NCT00695318|E3|Reported Event|0.5 ug/Day|"0.5 µg/Day~Fluocinolone Acetonide: 0.5 µg/Day~Ocular AEs"
1050518|NCT00695318|E2|Reported Event|0.2 ug/Day|"0.2 µg/Day~Fluocinolone Acetonide: 0.2 µg/Day~Ocular AEs"
1050519|NCT00695318|E1|Reported Event|Sham Injection|"Sham Injection~Sham Injection: Sham injection~Ocular AEs"
1050520|NCT00695292|B1|Baseline|Irinotecan, Carboplatin, Sunitinib|Patients receive irinotecan 60mg/m2 IV on days 1, 8, and 15 and carboplatin AUC=4 on day 1 of each 28-day cycle. After completion of 6 cycles, patients receive only sunitinib 25 mg daily by mouth.
1050521|NCT00695292|P1|Participant Flow|Irinotecan, Carboplatin, Sunitinib|Patients receive irinotecan 60mg/m2 IV on days 1, 8, and 15 and carboplatin AUC=4 on day 1 of each 28-day cycle. After completion of 6 cycles, patients receive only sunitinib 25 mg daily by mouth.
1050522|NCT00695292|O1|Outcome|Irinotecan, Carboplatin, Sunitinib|Patients receive irinotecan 60mg/m2 IV on days 1, 8, and 15 and carboplatin AUC=4 on day 1 of each 28-day cycle. After completion of 6 cycles, patients receive only sunitinib 25 mg daily by mouth.
1050523|NCT00695292|O1|Outcome|Irinotecan, Carboplatin, Sunitinib|Patients receive irinotecan 60mg/m2 IV on days 1, 8, and 15 and carboplatin AUC=4 on day 1 of each 28-day cycle. After completion of 6 cycles, patients receive only sunitinib 25 mg daily by mouth.
1050524|NCT00695292|E1|Reported Event|Intervention|Patients in the study will receive the following for the duration of the study: irinotecan 60 mg/m2 intravenously on Days 1, 8, and 15 and carboplatin AUC=4 on Day 1. The study will consist of 28-day cycles, to a maximum of 6 cycles of therapy with irinotecan and carboplatin. After treatment with irinotecan and carboplatin, sunitinib will be given alone as maintenance therapy in all patients who have achieved study entry hematologic criteria and who do not have progressive disease or severe toxicity. During sunitinib maintenance therapy, patients will receive sunitinib at 25 mg orally daily. Sunitinib maintenance therapy will continue until progressive disease or irreversible toxicity occurs.
1050525|NCT00695188|B3|Baseline|Total|Total of all reporting groups
1050526|NCT00695188|B2|Baseline|High Dose|Start with 25 mg MTX per week, administered orally
1050527|NCT00695188|B1|Baseline|Standard Dose|Escalating dose (Start with 15 mg MTX/week, escalating dose until 25 mg/week, administered orally)
1050528|NCT00695188|P2|Participant Flow|High Dose|Start with 25 mg MTX per week, administered orally
1050529|NCT00695188|P1|Participant Flow|Standard Dose|Escalating dose (Start with 15 mg MTX/week, escalating dose until 25 mg/week, administered orally)
1050530|NCT00695188|O2|Outcome|High Dose|Start with 25 mg MTX per week, administered orally
1050531|NCT00695188|O1|Outcome|Standard Dose|Escalating dose (Start with 15 mg MTX/week, escalating dose until 25 mg/week, administered orally)
1050532|NCT00695188|E2|Reported Event|High Dose|Start with 25 mg MTX per week, administered orally
1050533|NCT00695188|E1|Reported Event|Standard Dose|Escalating dose (Start with 15 mg MTX/week, escalating dose until 25 mg/week, administered orally)
1050534|NCT00695136|B1|Baseline|Open Label Single Arm|"Single group study of Donepezil~Increase REM sleep percentage :~Donepezil hydrochloride :"
1050921|NCT00693472|E4|Reported Event|Part 2: Preladenant|Preladenant 25 mg every 12 hours for 13 days
1050535|NCT00695136|P1|Participant Flow|Open Label Single Arm|"The children start by taking 1.25 mg of donepezil for 2 to 4 weeks. Those whose REM sleep increases to normal levels stay on 1.25 mg of donepezil for 8 more weeks. That ends their participation in the study.~Children whose REM sleep does not increase to normal on 1.25 mg of donepezil are given a higher dose (2.5 mg) for 2 to 4 weeks. Those whose REM sleep does not increase to normal on 2.5 mg of donepezil take 5 mg of the drug for 2 to 4 weeks. Children whose REM sleep does not increase to normal on 5 mg of donepezil stop the medication and end their participation in the study."
1050536|NCT00695136|O1|Outcome|Open Label Single Arm|"Single group study of Donepezil~Increase REM sleep percentage :~Donepezil hydrochloride :"
1050537|NCT00695136|E1|Reported Event|Open Label Single Arm|"Single group study of Donepezil~Increase REM sleep percentage :~Donepezil hydrochloride :"
1050538|NCT00695097|B3|Baseline|Total|Total of all reporting groups
1050539|NCT00695097|B2|Baseline|Control Group|No Rituximab; Standard maintenance immunosuppressive regimen only followed up monthly for 1 year.
1050540|NCT00695097|B1|Baseline|Rituximab Group|Rituximab Group: The Rituximab dose is 1000mg (1gm) given as an IV infusion every two weeks for 2 doses (days 1 and 15) and followed monthly for 1 year.
1050541|NCT00695097|P2|Participant Flow|Control Group|No Rituximab; Standard maintenance immunosuppressive regimen only and being followed monthly for 1 year.
1050542|NCT00695097|P1|Participant Flow|Rituximab Group|Rituximab Group: Rituximab dose is 1000 mg given as an IV infusion every 2 weeks (day 1 and 15) and followed monthly for 1 year.
1050543|NCT00695097|O2|Outcome|Control Group|No Rituximab infusion
1050544|NCT00695097|O1|Outcome|Rituximab Group|Rituximab infusion day 1 and 15
1050545|NCT00695097|E2|Reported Event|Control Group|No Rituximab; Standard maintenance immunosuppressive regimen only.
1050546|NCT00695097|E1|Reported Event|Rituximab Group|Rituximab Group: Rituximab infusion day 1 and day 14.
1050547|NCT00695019|B4|Baseline|Total|Total of all reporting groups
1050548|NCT00695019|B3|Baseline|Placebo|placebo lozenges taken 3 times per day
1050549|NCT00695019|B2|Baseline|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
1050550|NCT00695019|B1|Baseline|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges
1050551|NCT00695019|P3|Participant Flow|Placebo|placebo lozenges taken 3 times per day
1050552|NCT00695019|P2|Participant Flow|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
1050553|NCT00695019|P1|Participant Flow|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges
1050554|NCT00695019|O3|Outcome|Placebo|placebo lozenges taken 3 times per day
1050555|NCT00695019|O2|Outcome|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
1050556|NCT00695019|O1|Outcome|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
1050557|NCT00695019|O3|Outcome|Placebo|placebo lozenges taken 3 times per day
1050558|NCT00695019|O2|Outcome|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
1050559|NCT00695019|O1|Outcome|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
1050560|NCT00695019|O3|Outcome|Placebo|placebo lozenges taken 3 times per day
1050561|NCT00695019|O2|Outcome|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
1050562|NCT00695019|O1|Outcome|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
1050563|NCT00695019|O3|Outcome|Placebo|placebo lozenges taken 3 times per day
1050564|NCT00695019|O2|Outcome|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
1050565|NCT00695019|O1|Outcome|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
1050566|NCT00695019|O3|Outcome|Placebo|placebo lozenges taken 3 times per day
1050567|NCT00695019|O2|Outcome|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
1050568|NCT00695019|O1|Outcome|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
1050569|NCT00695019|O3|Outcome|Placebo|placebo lozenges taken 3 times per day
1050570|NCT00695019|O2|Outcome|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
1050571|NCT00695019|O1|Outcome|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
1050572|NCT00695019|O3|Outcome|Placebo|placebo lozenges taken 3 times per day
1050573|NCT00695019|O2|Outcome|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
1050574|NCT00695019|O1|Outcome|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
1050575|NCT00695019|O3|Outcome|Placebo|placebo lozenges taken 3 times per day
1050576|NCT00695019|O2|Outcome|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
1050577|NCT00695019|O1|Outcome|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
1050578|NCT00695019|E3|Reported Event|Placebo|placebo lozenges taken 3 times per day
1050579|NCT00695019|E2|Reported Event|500 IU Tid|500 IU interferon-alpha lozenge taken 3 times per day
1050580|NCT00695019|E1|Reported Event|500 IU qd|500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
1050581|NCT00694603|B1|Baseline|Cetuximab|Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.
1050582|NCT00694603|P1|Participant Flow|Cetuximab|Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.
1050583|NCT00694603|O1|Outcome|Cetuximab|Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.
1050584|NCT00694603|O1|Outcome|Cetuximab|Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.
1050585|NCT00694603|E1|Reported Event|Cetuximab|Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.
1050586|NCT00694564|B1|Baseline|Sam-e (Treatment)|"This an open-labeled study. All participants will be part of the treatment group and receive SAM-e.~S-adenosyl methionine : S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily."
1050587|NCT00694564|P1|Participant Flow|SAM-e|"This an open-labeled study. All participants will receive SAM-e.~S-adenosyl methionine : S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily."
1050588|NCT00694564|O1|Outcome|SAM-e|"This an open-labeled study. All participants will receive SAM-e.~S-adenosyl methionine : S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily."
1050589|NCT00694564|E1|Reported Event|Sam-e (Treatment)|"This an open-labeled study. All participants will be part of the treatment group and receive SAM-e.~S-adenosyl methionine : S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily."
1050590|NCT00694551|B4|Baseline|Total|Total of all reporting groups
1050591|NCT00694551|B3|Baseline|C. Peptide Vaccine|"Peptide vaccine dose level 1 mg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
1050592|NCT00694551|B2|Baseline|B. Peptide Vaccine|"Peptide vaccine dose level 300 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
1050593|NCT00694551|B1|Baseline|A. Peptide Vaccine|"Peptide vaccine dose Level 100 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
1050594|NCT00694551|P3|Participant Flow|C. Level 1 mg Peptide Vaccine|"Peptide vaccine dose level 1 mg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
1050595|NCT00694551|P2|Participant Flow|B. Level 300 mcg Peptide Vaccine|"Peptide vaccine dose level 300 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
1050596|NCT00694551|P1|Participant Flow|A. Level 100 mcg Peptide Vaccine|"Peptide vaccine dose level 100 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
1050597|NCT00694551|O3|Outcome|C. Level 1 mg Peptide Vaccine|"Peptide vaccine dose level 1 mg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
1050598|NCT00694551|O2|Outcome|B. Level 300 mcg Peptide Vaccine|"Peptide vaccine dose level 300 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
1050599|NCT00694551|O1|Outcome|A. Level 100 mcg Peptide Vaccine|"Peptide vaccine dose level 100 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
1050600|NCT00694551|O3|Outcome|C. Level 1 mg Peptide Vaccine|"Peptide vaccine dose level 1 mg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
1050601|NCT00694551|O2|Outcome|B. Level 300 mcg Peptide Vaccine|"Peptide vaccine dose level 300 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
1050602|NCT00694551|O1|Outcome|A. Level 100 mcg Peptide Vaccine|"Peptide vaccine dose level 100 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
1050603|NCT00694551|O3|Outcome|C. Level 1 mg Peptide Vaccine|"Peptide vaccine dose level 1 mg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
1050604|NCT00694551|O2|Outcome|B. Level 300 mcg Peptide Vaccine|"Peptide vaccine dose level 300 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
1050605|NCT00694551|O1|Outcome|A. Level 100 mcg Peptide Vaccine|"Peptide vaccine dose Level 100 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
1050606|NCT00694551|E3|Reported Event|C. Peptide Vaccine|"Peptide vaccine dose level 1 mg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
1050738|NCT00694122|O2|Outcome|NPH Insulin|NPH was the given at 22:00 on the evening of the overnight admission.
1050607|NCT00694551|E2|Reported Event|B. Peptide Vaccine|"Peptide vaccine dose level 300 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
1050608|NCT00694551|E1|Reported Event|A. Peptide Vaccine|"Peptide vaccine dose Level 100 mcg~Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment."
1050609|NCT00694369|B6|Baseline|Total|Total of all reporting groups
1050610|NCT00694369|B5|Baseline|Acetaminophen 2400 mg/Codeine 240 mg|Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
1050611|NCT00694369|B4|Baseline|Ibuprofen 2400 mg|Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally
1050612|NCT00694369|B3|Baseline|Etoricoxib 120 mg|Etoricoxib 120 mg orally once daily
1050613|NCT00694369|B2|Baseline|Etoricoxib 90 mg|Etoricoxib 90 mg orally once daily
1050614|NCT00694369|B1|Baseline|Placebo|Placebo orally once daily
1050615|NCT00694369|P5|Participant Flow|Acetaminophen 2400 mg/Codeine 240 mg|Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
1050616|NCT00694369|P4|Participant Flow|Ibuprofen 2400 mg|Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally
1050617|NCT00694369|P3|Participant Flow|Etoricoxib 120 mg|Etoricoxib 120 mg orally once daily
1050618|NCT00694369|P2|Participant Flow|Etoricoxib 90 mg|Etoricoxib 90 mg orally once daily
1050619|NCT00694369|P1|Participant Flow|Placebo|Placebo orally once daily
1050620|NCT00694369|O5|Outcome|Acetaminophen 2400 mg/Codeine 240 mg|Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
1050621|NCT00694369|O4|Outcome|Ibuprofen 2400 mg|Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally
1050622|NCT00694369|O3|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg orally once daily
1050623|NCT00694369|O2|Outcome|Etoricoxib 90 mg|Etoricoxib 90 mg orally once daily
1050624|NCT00694369|O1|Outcome|Placebo|Placebo orally once daily
1050625|NCT00694369|O5|Outcome|Acetaminophen 2400 mg/Codeine 240 mg|Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
1050626|NCT00694369|O4|Outcome|Ibuprofen 2400 mg|Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally
1050627|NCT00694369|O3|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg orally once daily
1050628|NCT00694369|O2|Outcome|Etoricoxib 90 mg|Etoricoxib 90 mg orally once daily
1050629|NCT00694369|O1|Outcome|Placebo|Placebo orally once daily
1050630|NCT00694369|E5|Reported Event|Acetaminophen 2400 mg/Codeine 240 mg|Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
1050631|NCT00694369|E4|Reported Event|Ibuprofen 2400 mg|Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally
1050632|NCT00694369|E3|Reported Event|Etoricoxib 120 mg|Etoricoxib 120 mg orally once daily
1050633|NCT00694369|E2|Reported Event|Etoricoxib 90 mg|Etoricoxib 90 mg orally once daily
1050634|NCT00694369|E1|Reported Event|Placebo|Placebo orally once daily
1050635|NCT00694356|B4|Baseline|Total|Total of all reporting groups
1050636|NCT00694356|B3|Baseline|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050637|NCT00694356|B2|Baseline|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050638|NCT00694356|B1|Baseline|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050639|NCT00694356|P3|Participant Flow|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050640|NCT00694356|P2|Participant Flow|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050641|NCT00694356|P1|Participant Flow|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by intravenous (IV) infusion once each week for up to 1 year or until participant withdraws consent, experiences an adverse event (AE), progressive disease or major protocol violation, has moved or is lost to follow up.
1050642|NCT00694356|O3|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050643|NCT00694356|O2|Outcome|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050644|NCT00694356|O1|Outcome|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050645|NCT00694356|O3|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050646|NCT00694356|O2|Outcome|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050647|NCT00694356|O1|Outcome|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050648|NCT00694356|O3|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050649|NCT00694356|O2|Outcome|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050650|NCT00694356|O1|Outcome|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050651|NCT00694356|O3|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050652|NCT00694356|O2|Outcome|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050653|NCT00694356|O1|Outcome|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050654|NCT00694356|O3|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050655|NCT00694356|O2|Outcome|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050656|NCT00694356|O1|Outcome|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050657|NCT00694356|O3|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050658|NCT00694356|O2|Outcome|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050659|NCT00694356|O1|Outcome|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050660|NCT00694356|O3|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050661|NCT00694356|O2|Outcome|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050662|NCT00694356|O1|Outcome|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050663|NCT00694356|O3|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050664|NCT00694356|O2|Outcome|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050665|NCT00694356|O1|Outcome|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050666|NCT00694356|O3|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050667|NCT00694356|O2|Outcome|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050668|NCT00694356|O1|Outcome|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050669|NCT00694356|O3|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050670|NCT00694356|O2|Outcome|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050671|NCT00694356|O1|Outcome|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050672|NCT00694356|E3|Reported Event|Dalotuzumab 15 mg/kg/7.5 mg/kg|Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050673|NCT00694356|E2|Reported Event|Dalotuzumab 10 mg/kg|Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050674|NCT00694356|E1|Reported Event|Dalotuzumab 5 mg/kg|Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
1050675|NCT00694304|B1|Baseline|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
1050676|NCT00694304|P1|Participant Flow|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
1050677|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
1050678|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
1050679|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
1050680|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
1050681|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
1050682|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
1050683|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
1050684|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
1050685|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
1050686|NCT00694304|O1|Outcome|Vortioxetine 2.5, 5, or 10 mg/Day|tablets; orally
1050687|NCT00694304|E1|Reported Event|Vortioxetine 2.5, 5, or 10 mg/Day|
1050688|NCT00694161|B1|Baseline|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050689|NCT00694161|P1|Participant Flow|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050690|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050691|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050692|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050693|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050694|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050695|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050696|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050697|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050739|NCT00694122|O1|Outcome|Glargine (Lantus) Insulin|Glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission.
1050740|NCT00694122|O2|Outcome|NPH Insulin|NPH was given at 22:00 on the evening of the overnight admission.
1050698|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050699|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050700|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050701|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050702|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050703|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050704|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050705|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050706|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050707|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050708|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050709|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050710|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050711|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050712|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050713|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050714|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050741|NCT00694122|O1|Outcome|Glargine (Lantus) Insulin|Glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission.;
1050715|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050716|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050717|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050718|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050719|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050720|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050721|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050722|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050723|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050724|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050725|NCT00694161|O1|Outcome|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050726|NCT00694161|E1|Reported Event|Tafamidis|Participants with variant transthyretin (TTR) genotype (valine replaced at position 122 by isoleucine or V122I) and wild-type TTR genotype received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1 and participants who achieved TTR stabilization at Week 6 continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1050727|NCT00694122|B1|Baseline|All Study Participants|"Lantus insulin once per day and blood glucose outcomes was studied during the first overnight visit; then the subject was discharged on NPH on twice per day NPH. Upon the second overnight visit, NPH insulin and blood glucose outcomes was studied.~If the participant entered the study on NPH, NPH insulin given twice per day and blood glucose outcomes was studied during the first overnight visit; then the subject was discharged on once per day Lantus. Upon the second overnight visit, Lantus insulin and blood glucose outcomes was studied"
1050728|NCT00694122|P2|Participant Flow|NPH First, Then Lantus|NPH was given twice per day in the first intervention period for 3-4 weeks and .Lantus was given once per day in second intervention period for 3-4 weeks.
1050729|NCT00694122|P1|Participant Flow|Lantus First, Then NPH|Lantus insulin once per day and blood glucose outcomes was studied during the first overnight visit; then the subject was discharged on NPH on twice per day NPH. Upon the second overnight visit, NPH insulin and blood glucose outcomes was studied
1050730|NCT00694122|O2|Outcome|NPH Insulin|NPH was given at 22:00 on the evening of the overnight admission.
1050731|NCT00694122|O1|Outcome|Glargine (Lantus) Insulin|Glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission. .
1050732|NCT00694122|O2|Outcome|NPH Insulin|NPH was given at 22:00 on the evening of the overnight admission.
1050733|NCT00694122|O1|Outcome|Glargine (Lantus) Insulin|Glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission.
1050734|NCT00694122|O2|Outcome|NPH Insulin|NPH was given at 22:00 on the evening of the overnight admission.
1050735|NCT00694122|O1|Outcome|Glargine (Lantus) Insulin|Glargine (Lantus) was given at 22:00 on the evening of the overnight admission.
1050736|NCT00694122|O2|Outcome|NPH Insulin|NPH was given at 22:00 on the evening of the overnight admission.
1050737|NCT00694122|O1|Outcome|Glargine (Lantus)|glargine (Lantus) was given once per day at 22:00 on the evening of the overnight admission.
1050744|NCT00694109|B1|Baseline|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
1050745|NCT00694109|P1|Participant Flow|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
1050746|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
1050747|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
1050748|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
1050749|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
1050750|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) once a week subcutaneously for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
1050751|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
1050752|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
1050753|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
1050754|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
1050755|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
1050756|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
1050757|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
1050758|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
1050759|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
1050760|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
1050761|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
1050762|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
1050763|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
1050764|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
1050765|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
1050766|NCT00694109|O1|Outcome|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
1050767|NCT00694109|E1|Reported Event|Mipomersen|Mipomersen Sodium 200 mg (for participants weighed ≥ 50 kg) or 160 mg (for participants weighed <50 kg) subcutaneous injection once a week for up to 4 years (depending on participant's consent). Participants were followed for additional 24 week post-treatment.
1050768|NCT00694096|B1|Baseline|Arm 1 - Sunitinib 37.5 mg|Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
1050769|NCT00694096|P1|Participant Flow|Arm 1 - Sunitinib 37.5 mg|Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
1050770|NCT00694096|O1|Outcome|Arm 1 - Sunitinib 37.5 mg|Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
1050771|NCT00694096|O1|Outcome|Arm 1 - Sunitinib 37.5 mg|Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
1050772|NCT00694096|O1|Outcome|Arm 1 - Sunitinib 37.5 mg|Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
1050773|NCT00694096|E1|Reported Event|Arm 1 - Sunitinib 37.5 mg|Sunitinib: Imaging studies with complete analyses for patients prior to initiation of sunitinib therapy at 37.5 mg orally/day, and at time points between 1 and 4 weeks after initiation of sunitinib therapy.
1050774|NCT00694070|B1|Baseline|Health Care Professionals and Lay Users|h= 8 health care professionals p= 43 lay users
1050775|NCT00694070|P1|Participant Flow|Health Care Professionals and Lay Users|h= 8 health care professionals p= 43 lay users
1050776|NCT00694070|O1|Outcome|Health Care Professionals and Lay Users|h= 8 health care professionals p= 43 lay users
1050777|NCT00694070|O1|Outcome|Health Care Professionals and Lay Users|h= 8 health care professionals p= 43 lay users
1050778|NCT00694070|O1|Outcome|Health Care Professionals and Lay Users|h= 8 health care professionals p= 43 lay users
1050779|NCT00694070|E1|Reported Event|Health Care Professionals and Lay Users|h= 8 health care professionals p= 43 lay users
1050780|NCT00694018|B3|Baseline|Total|Total of all reporting groups
1050781|NCT00694018|B2|Baseline|Internet Mediated Enhanced Pedometer|"Education and standard care: Educational program for individuals with chronic back pain.~Internet mediated enhanced pedometer intervention: Enhanced pedometer for uploading step information and website that provides step goals and feedback, tailored motivational messages and an online community."
1050782|NCT00694018|B1|Baseline|Education and Standard Care|Education and standard care: Educational program for individuals with chronic back pain.
1050783|NCT00694018|P2|Participant Flow|Internet Mediated Enhanced Pedometer|"Education and standard care: Educational program for individuals with chronic back pain.~Internet mediated enhanced pedometer intervention: Enhanced pedometer for uploading step information and website that provides step goals and feedback, tailored motivational messages and an online community."
1050784|NCT00694018|P1|Participant Flow|Education and Standard Care|Education and standard care: Educational program for individuals with chronic back pain.
1050785|NCT00694018|O2|Outcome|Internet Mediated Enhanced Pedometer|"Education and standard care: Educational program for individuals with chronic back pain.~Internet mediated enhanced pedometer intervention: Enhanced pedometer for uploading step information and website that provides step goals and feedback, tailored motivational messages and an online community."
1050786|NCT00694018|O1|Outcome|Education and Standard Care|Education and standard care: Educational program for individuals with chronic back pain.
1050787|NCT00694018|E2|Reported Event|Internet Mediated Enhanced Pedometer|"Education and standard care: Educational program for individuals with chronic back pain.~Internet mediated enhanced pedometer intervention: Enhanced pedometer for uploading step information and website that provides step goals and feedback, tailored motivational messages and an online community."
1050788|NCT00694018|E1|Reported Event|Education and Standard Care|Education and standard care: Educational program for individuals with chronic back pain.
1050789|NCT00693992|B3|Baseline|Total|Total of all reporting groups
1050790|NCT00693992|B2|Baseline|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies"
1050791|NCT00693992|B1|Baseline|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Sunitinib Malate: Given PO"
1050792|NCT00693992|P2|Participant Flow|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies"
1050793|NCT00693992|P1|Participant Flow|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Sunitinib Malate: Given PO"
1050794|NCT00693992|O2|Outcome|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies"
1050795|NCT00693992|O1|Outcome|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Sunitinib Malate: Given PO"
1050796|NCT00693992|O2|Outcome|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies"
1050797|NCT00693992|O1|Outcome|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Sunitinib Malate: Given PO"
1050798|NCT00693992|O2|Outcome|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies"
1050799|NCT00693992|O1|Outcome|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Sunitinib Malate: Given PO"
1050800|NCT00693992|O2|Outcome|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies"
1050801|NCT00693992|O1|Outcome|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Sunitinib Malate: Given PO"
1050802|NCT00693992|E2|Reported Event|Arm II (Placebo)|"Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Placebo: Given PO~Quality-of-Life Assessment: Ancillary studies"
1050803|NCT00693992|E1|Reported Event|Arm I (Sunitinib Malate)|"Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Sunitinib Malate: Given PO"
1050804|NCT00693784|B1|Baseline|BIOSTAT BIOLOGX|1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
1050805|NCT00693784|P1|Participant Flow|BIOSTAT BIOLOGX|1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
1050806|NCT00693784|O1|Outcome|BIOSTAT BIOLOGX|1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
1050807|NCT00693784|O1|Outcome|BIOSTAT BIOLOGX|1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
1050808|NCT00693784|O1|Outcome|BIOSTAT BIOLOGX|1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
1050809|NCT00693784|E1|Reported Event|BIOSTAT BIOLOGX|1 injection of from 1 to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant
1050810|NCT00693719|B1|Baseline|Etoposide/Irinotecan|"Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle~Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle"
1050811|NCT00693719|P1|Participant Flow|Etoposide/Irinotecan|"Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle~Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle"
1050812|NCT00693719|O1|Outcome|Etoposide/Irinotecan|"Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle~Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle"
1050813|NCT00693719|O1|Outcome|Etoposide/Irinotecan|"Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle~Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle"
1050814|NCT00693719|E1|Reported Event|Etoposide/Irinotecan|"Irinotecan hydrochloride : Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle~Etoposide : 50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle"
1050815|NCT00693706|B3|Baseline|Total|Total of all reporting groups
1050816|NCT00693706|B2|Baseline|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1050817|NCT00693706|B1|Baseline|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1050818|NCT00693706|P2|Participant Flow|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1050819|NCT00693706|P1|Participant Flow|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1050820|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1050821|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1050822|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1050823|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1050824|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1050825|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1050826|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1050827|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1050828|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1050829|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1050830|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1050831|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1050832|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1050833|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1050834|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1050835|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1050836|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1050837|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1050838|NCT00693706|O2|Outcome|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1050839|NCT00693706|O1|Outcome|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1050840|NCT00693706|E2|Reported Event|Fluarix Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1050841|NCT00693706|E1|Reported Event|GSK 1388442A Group|Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1050842|NCT00693693|B4|Baseline|Total|Total of all reporting groups
1050843|NCT00693693|B3|Baseline|Lipocream|topical hydrocortisone 17-butyrate 0.1% Lipocream applied twice daily
1050844|NCT00693693|B2|Baseline|Ointment|topical hydrocortisone 17-butyrate 0.1% ointment applied twice daily
1050845|NCT00693693|B1|Baseline|Cream|topical hydrocortisone 17-butyrate 0.1% cream applied twice daily
1050846|NCT00693693|P3|Participant Flow|Cream|topical hydrocortisone 17-butyrate 0.1% preparation cream
1050847|NCT00693693|P2|Participant Flow|Lipocream|topical hydrocortisone 17-butyrate 0.1% preparation lipocream
1050848|NCT00693693|P1|Participant Flow|Ointment|topical hydrocortisone 17-butyrate 0.1% preparation ointment
1050849|NCT00693693|O3|Outcome|Lipocream|topical hydrocortisone 17-butyrate 0.1% Lipocream applied twice daily to all areas of atopic dermatitis
1050850|NCT00693693|O2|Outcome|Ointment|topical hydrocortisone 17-butyrate 0.1% ointment applied twice daily to all areas of atopic dermatitis
1050851|NCT00693693|O1|Outcome|Cream|topical hydrocortisone 17-butyrate 0.1% cream applied twice daily to all areas of atopic dermatitis
1050852|NCT00693693|E3|Reported Event|Topical Hydrocortisone 17-butyrate 0.1% Lipocream|topical hydrocortisone 17-butyrate 0.1% lipocream applied twice daily
1050853|NCT00693693|E2|Reported Event|Topical Hydrocortisone 17-butyrate 0.1% Ointment|topical hydrocortisone 17-butyrate 0.1% ointment applied twice daily
1050854|NCT00693693|E1|Reported Event|Topical Hydrocortisone 17-butyrate 0.1% Cream|topical hydrocortisone 17-butyrate 0.1% cream applied twice daily
1050855|NCT00693654|B3|Baseline|Total|Total of all reporting groups
1050856|NCT00693654|B2|Baseline|Placebo|Placebo lotion (Cetaphil)
1050857|NCT00693654|B1|Baseline|Active|Active Medicated Lotion (Sarna)
1050858|NCT00693654|P2|Participant Flow|Placebo Cetaphil Lotion|Placebo lotion (Cetaphil) applied twice daily to areas of pruritus
1050859|NCT00693654|P1|Participant Flow|Pramoxine Lotion|Active Medicated Pramoxine Lotion (Sarna) applied topically twice daily to areas of pruritus
1050860|NCT00693654|O2|Outcome|Placebo|Placebo lotion (Cetaphil)
1050861|NCT00693654|O1|Outcome|Active|Active Medicated Lotion (Sarna)
1050862|NCT00693654|O2|Outcome|Placebo|Placebo lotion (Cetaphil)
1050863|NCT00693654|O1|Outcome|Active|Active Medicated Pramoxine Lotion (Sarna)
1050864|NCT00693654|E2|Reported Event|Placebo|Placebo lotion (Cetaphil)
1050865|NCT00693654|E1|Reported Event|Active|Active Medicated Lotion (Sarna)
1050866|NCT00693628|B3|Baseline|Total|Total of all reporting groups
1050867|NCT00693628|B2|Baseline|No Shrinker|Patients will receive no shrinker
1050868|NCT00693628|B1|Baseline|Shrinker|"Patients receive 20-30 mmHg or 30-40 mmHg shrinker, an elastic compression garment that is worn on the residual limb and is used to reduce edema and promote healing.~compression shrinker: Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker"
1050869|NCT00693628|P2|Participant Flow|No Shrinker|Patients will receive no shrinker
1050870|NCT00693628|P1|Participant Flow|Shrinker|"Patients receive 20-30 mmHg or 30-40 mmHg shrinker, an elastic compression garment that is worn on the residual limb and is used to reduce edema and promote healing.~compression shrinker: Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker"
1050871|NCT00693628|O2|Outcome|No Shrinker|Patients will receive no shrinker
1050872|NCT00693628|O1|Outcome|Shrinker|"Patients receive 20-30 mmHg or 30-40 mmHg shrinker, an elastic compression garment that is worn on the residual limb and is used to reduce edema and promote healing.~compression shrinker: Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker"
1050873|NCT00693628|E2|Reported Event|No Shrinker|Patients will receive no shrinker
1050874|NCT00693628|E1|Reported Event|Shrinker|"Patients receive 20-30 mmHg or 30-40 mmHg shrinker, an elastic compression garment that is worn on the residual limb and is used to reduce edema and promote healing.~compression shrinker: Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker"
1050875|NCT00693498|B3|Baseline|Total|Total of all reporting groups
1050876|NCT00693498|B2|Baseline|Washed Transfusion Group|Washed leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
1050877|NCT00693498|B1|Baseline|Standard Transfusion Group|Standard leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
1050878|NCT00693498|P2|Participant Flow|Washed Transfusion Group|Washed leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
1050879|NCT00693498|P1|Participant Flow|Standard Transfusion Group|Standard leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
1050880|NCT00693498|O2|Outcome|Washed Transfusion Group|Washed leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
1050881|NCT00693498|O1|Outcome|Standard Transfusion Group|Standard leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
1050882|NCT00693498|E2|Reported Event|Washed Transfusion Group|Washed leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
1050883|NCT00693498|E1|Reported Event|Standard Transfusion Group|Standard leukoreduced irradiated ABO compatible red blood cell and platelet transfusion group
1050884|NCT00693485|B4|Baseline|Total|Total of all reporting groups
1050885|NCT00693485|B3|Baseline|Sham (no Implant)|Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
1050886|NCT00693485|B2|Baseline|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
1050887|NCT00693485|B1|Baseline|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
1050888|NCT00693485|P3|Participant Flow|Sham (no Implant)|Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
1050889|NCT00693485|P2|Participant Flow|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
1050890|NCT00693485|P1|Participant Flow|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
1050891|NCT00693485|O3|Outcome|Sham (no Implant)|Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
1050892|NCT00693485|O2|Outcome|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
1050893|NCT00693485|O1|Outcome|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
1050894|NCT00693485|O3|Outcome|Sham (no Implant)|Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
1050895|NCT00693485|O2|Outcome|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
1050896|NCT00693485|O1|Outcome|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
1050897|NCT00693485|E3|Reported Event|Sham (no Implant)|Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
1050898|NCT00693485|E2|Reported Event|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
1050899|NCT00693485|E1|Reported Event|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
1050900|NCT00693472|B5|Baseline|Total|Total of all reporting groups
1050901|NCT00693472|B4|Baseline|Part 2: Standard of Care|Anticholinergic agents or Propranolol as standard-of-care dosing regimen (supplied by the study site)
1050902|NCT00693472|B3|Baseline|Part 2: Preladenant|Preladenant 25 mg every 12 hours for 13 days
1050903|NCT00693472|B2|Baseline|Part 1: Placebo|Placebo every 12 hours for 13 days
1050904|NCT00693472|B1|Baseline|Part 1: Preladenant|Preladenant 25 mg every 12 hours for 13 days
1050905|NCT00693472|P4|Participant Flow|Part 2: Standard of Care|Anticholinergic agents or Propranolol as standard-of-care dosing regimen (supplied by the study site)
1050906|NCT00693472|P3|Participant Flow|Part 2: Preladenant|Preladenant 25 mg every 12 hours for 13 days
1050907|NCT00693472|P2|Participant Flow|Part 1: Placebo|Placebo every 12 hours for 13 days
1050908|NCT00693472|P1|Participant Flow|Part 1: Preladenant|Preladenant 25 mg every 12 hours for 13 days
1050909|NCT00693472|O2|Outcome|Part 2: Standard of Care|Anticholinergic agents or Propranolol as standard-of-care dosing regimen (supplied by the study site)
1050910|NCT00693472|O1|Outcome|Part 2: Preladenant|Preladenant 25 mg every 12 hours for 13 days
1050911|NCT00693472|O2|Outcome|Part 2: Standard of Care|Anticholinergic agents or Propranolol as standard-of-care dosing regimen (supplied by the study site)
1050912|NCT00693472|O1|Outcome|Part 2: Preladenant|Preladenant 25 mg every 12 hours for 13 days
1050913|NCT00693472|O2|Outcome|Part 1: Placebo|Placebo every 12 hours for 13 days
1050914|NCT00693472|O1|Outcome|Part 1: Preladenant|Preladenant 25 mg every 12 hours for 13 days
1050915|NCT00693472|O2|Outcome|Part 1: Placebo|Placebo every 12 hours for 13 days
1050916|NCT00693472|O1|Outcome|Part 1: Preladenant|Preladenant 25 mg every 12 hours for 13 days
1050917|NCT00693472|O2|Outcome|Part 2: Standard of Care|Anticholinergic agents or Propranolol as standard-of-care dosing regimen (supplied by the study site)
1050918|NCT00693472|O1|Outcome|Part 2: Preladenant|Preladenant 25 mg every 12 hours for 13 days
1050919|NCT00693472|O2|Outcome|Part 1: Placebo|Placebo every 12 hours for 13 days
1050920|NCT00693472|O1|Outcome|Part 1: Preladenant|Preladenant 25 mg every 12 hours for 13 days
1057123|NCT00675792|O1|Outcome|Sugammadex|4 mg/kg sugammadex
1050922|NCT00693472|E3|Reported Event|Part 2: Standard of Care|Anticholinergic agents or Propranolol as standard-of-care dosing regimen (supplied by the study site)
1050923|NCT00693472|E2|Reported Event|Part 1: Preladenant|Preladenant 25 mg every 12 hours for 13 days
1050924|NCT00693472|E1|Reported Event|Part 1: Placebo|Placebo every 12 hours for 13 days
1050925|NCT00693420|B3|Baseline|Total|Total of all reporting groups
1050926|NCT00693420|B2|Baseline|Vehicle Solution|
1050927|NCT00693420|B1|Baseline|Bimatoprost 0.03% Solution|
1050928|NCT00693420|P2|Participant Flow|Vehicle Solution|
1050929|NCT00693420|P1|Participant Flow|Bimatoprost 0.03% Solution|
1050930|NCT00693420|O2|Outcome|Vehicle Solution|
1050931|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
1050932|NCT00693420|O2|Outcome|Vehicle Solution|
1050933|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
1050934|NCT00693420|O2|Outcome|Vehicle Solution|
1050935|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
1050936|NCT00693420|O2|Outcome|Vehicle Solution|
1050937|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
1050938|NCT00693420|O2|Outcome|Vehicle Solution|
1050939|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
1050940|NCT00693420|O2|Outcome|Vehicle Solution|
1050941|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
1050942|NCT00693420|O2|Outcome|Vehicle Solution|
1050943|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
1050944|NCT00693420|O2|Outcome|Vehicle Solution|
1050945|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
1050946|NCT00693420|O2|Outcome|Vehicle Solution|
1050947|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
1050948|NCT00693420|O2|Outcome|Vehicle Solution|
1050949|NCT00693420|O1|Outcome|Bimatoprost 0.03% Solution|
1050950|NCT00693420|E2|Reported Event|Vehicle Solution|
1050951|NCT00693420|E1|Reported Event|Bimatoprost 0.03% Solution|
1050952|NCT00693303|B1|Baseline|My Scrivener Training|Children received My Scrivenor training
1050953|NCT00693303|P1|Participant Flow|My Scrivener Training|Children received My Scrivenor training
1050954|NCT00693303|O1|Outcome|My Scrivener Training|Children received My Scrivenor training
1050955|NCT00693303|E1|Reported Event|My Scrivener Training|Children received My Scrivenor training
1050956|NCT00693238|B3|Baseline|Total|Total of all reporting groups
1050957|NCT00693238|B2|Baseline|Intermediate Risk Proton Radiation|72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
1050958|NCT00693238|B1|Baseline|Low Risk Proton Radiation|70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx
1050959|NCT00693238|P2|Participant Flow|Intermediate Risk Proton Radiation|72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
1050960|NCT00693238|P1|Participant Flow|Low Risk Proton Radiation|70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx
1050961|NCT00693238|O2|Outcome|Intermediate Risk Proton Radiation|72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
1050962|NCT00693238|O1|Outcome|Low Risk Proton Radiation|70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx
1050963|NCT00693238|E2|Reported Event|Intermediate Risk Proton Radiation|72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
1050964|NCT00693238|E1|Reported Event|Low Risk Proton Radiation|70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx
1050965|NCT00693225|B3|Baseline|Total|Total of all reporting groups
1050966|NCT00693225|B2|Baseline|Omeprazole/Sodium Bicarbonate PM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
1050967|NCT00693225|B1|Baseline|Omeprazole/Sodium Bicarbonate AM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning
1050968|NCT00693225|P2|Participant Flow|Omeprazole/Sodium Bicarbonate PM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
1050969|NCT00693225|P1|Participant Flow|Omeprazole/Sodium Bicarbonate AM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning
1050970|NCT00693225|O2|Outcome|Omeprazole/Sodium Bicarbonate PM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
1050971|NCT00693225|O1|Outcome|Omeprazole/Sodium Bicarbonate AM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning
1050972|NCT00693225|O2|Outcome|Omeprazole/Sodium Bicarbonate PM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
1050973|NCT00693225|O1|Outcome|Omeprazole/Sodium Bicarbonate AM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning
1050974|NCT00693225|O2|Outcome|Omeprazole/Sodium Bicarbonate PM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
1050975|NCT00693225|O1|Outcome|Omeprazole/Sodium Bicarbonate AM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning
1050976|NCT00693225|E2|Reported Event|Omeprazole/Sodium Bicarbonate PM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
1050977|NCT00693225|E1|Reported Event|Omeprazole/Sodium Bicarbonate AM Dose|8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning
1050978|NCT00693160|B3|Baseline|Total|Total of all reporting groups
1050979|NCT00693160|B2|Baseline|Placebo Intrathecal Injection|In the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline)
1050980|NCT00693160|B1|Baseline|Intrathecal Ketorolac|In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg
1051001|NCT00692913|B2|Baseline|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
1051002|NCT00692913|B1|Baseline|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
1051003|NCT00692913|P2|Participant Flow|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
1051090|NCT00692692|B1|Baseline|Acellular Dermal Matrix|vs control group with traditional muscle cover of tissue expander only
1050981|NCT00693160|P2|Participant Flow|Placebo Intrathecal Injection|"In the presence of remifentanil subjects received a single intrathecal injection of placebo (preservative-free normal saline).~The remifentanil infusion was initiated in each subject to a target concentration of 1.0 ng/ml using a computer controlled pump and the STANPUMP algorithm. The STANPUMP program, written by Dr. S.L. Shafer of Stanford University permits the administration of a pharmacokinetically tailored infusion to rapidly achieve and maintain a targeted plasma drug concentration.~The remifentanil infusion was titrated based on the subjects’ pain report to a 49 degree Celsius stimulus with the goal of producing approximately 50% decrease in verbal pain report of the 49 degree Celsius stimulus. Upon reaching the target concentration, a steady state infusion was then completed over 80-to 100 minutes."
1050982|NCT00693160|P1|Participant Flow|Intrathecal Ketorolac|"In the presence of a remifentanil infusion subjects received a single intrathecal injection of ketorolac 2 mg.~The remifentanil infusion was initiated in each subject to a target concentration of 1.0 ng/ml using a computer controlled pump and the STANPUMP algorithm. The STANPUMP program, written by Dr. S.L. Shafer of Stanford University permits the administration of a pharmacokinetically tailored infusion to rapidly achieve and maintain a targeted plasma drug concentration.~The remifentanil infusion was titrated based on the subjects’ pain report to a 49 degree Celsius stimulus with the goal of producing approximately 50% decrease in verbal pain report of the 49 degree Celsius stimulus. Upon reaching the target concentration, a steady state infusion was then completed over 80-to 100 minutes."
1050983|NCT00693160|O2|Outcome|Placebo Intrathecal Injection|In the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline)
1050984|NCT00693160|O1|Outcome|Intrathecal Ketorolac|In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg
1050985|NCT00693160|O2|Outcome|Placebo Intrathecal Injection|In the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline)
1050986|NCT00693160|O1|Outcome|Intrathecal Ketorolac|In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg
1050987|NCT00693160|E2|Reported Event|Placebo Intrathecal Injection|In the presence of remifentanil the subject will receive a single intrathecal injection of placebo (preservative-free normal saline)
1050988|NCT00693160|E1|Reported Event|Intrathecal Ketorolac|In the presence of a remifentanil infusion subject will receive a single intrathecal injection of ketorolac 2 mg
1050989|NCT00693017|B3|Baseline|Total|Total of all reporting groups
1050990|NCT00693017|B2|Baseline|Placebo|"50-400 mg Zonisamide Placebo capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
1050991|NCT00693017|B1|Baseline|Zonisamide|"50-400 mg capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
1050992|NCT00693017|P2|Participant Flow|Placebo|"50-400 mg Zonisamide Placebo capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
1050993|NCT00693017|P1|Participant Flow|Zonisamide|"50-400 mg capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
1050994|NCT00693017|O2|Outcome|Placebo|"50-400 mg Zonisamide Placebo capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
1050995|NCT00693017|O1|Outcome|Zonisamide|"50-400 mg capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
1050996|NCT00693017|O2|Outcome|Placebo|"50-400 mg Zonisamide Placebo capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
1050997|NCT00693017|O1|Outcome|Zonisamide|"50-400 mg capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
1050998|NCT00693017|E2|Reported Event|Placebo|"50-400 mg Zonisamide Placebo capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
1050999|NCT00693017|E1|Reported Event|Zonisamide|"50-400 mg capsules once daily in the evening orally.~Maximum study duration 28 weeks comprising:~Baseline Period (Week -8 to Week 0): no treatment~Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)~Down Titration Period (4 Weeks)"
1051000|NCT00692913|B3|Baseline|Total|Total of all reporting groups
1051004|NCT00692913|P1|Participant Flow|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
1051005|NCT00692913|O2|Outcome|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
1051006|NCT00692913|O1|Outcome|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
1051007|NCT00692913|O2|Outcome|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
1051008|NCT00692913|O1|Outcome|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
1051009|NCT00692913|O2|Outcome|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
1051010|NCT00692913|O1|Outcome|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
1051011|NCT00692913|O2|Outcome|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
1051012|NCT00692913|O1|Outcome|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
1051013|NCT00692913|O2|Outcome|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
1051014|NCT00692913|O1|Outcome|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
1051015|NCT00692913|O2|Outcome|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
1051016|NCT00692913|O1|Outcome|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
1051017|NCT00692913|O2|Outcome|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
1051018|NCT00692913|O1|Outcome|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
1051019|NCT00692913|O2|Outcome|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
1051020|NCT00692913|O1|Outcome|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
1051021|NCT00692913|E2|Reported Event|Referred-Care|Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
1051022|NCT00692913|E1|Reported Event|FOSAVANCE 5600|Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
1051023|NCT00692770|B3|Baseline|Total|Total of all reporting groups
1051024|NCT00692770|B2|Baseline|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
1051025|NCT00692770|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
1051026|NCT00692770|P2|Participant Flow|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
1051027|NCT00692770|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
1051028|NCT00692770|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
1051029|NCT00692770|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
1051030|NCT00692770|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
1051031|NCT00692770|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
1051032|NCT00692770|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
1051033|NCT00692770|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
1051034|NCT00692770|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
1051035|NCT00692770|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
1051036|NCT00692770|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
1051037|NCT00692770|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
1051038|NCT00692770|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
1051039|NCT00692770|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
1051040|NCT00692770|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
1051041|NCT00692770|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
1051042|NCT00692770|E2|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
1051043|NCT00692770|E1|Reported Event|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
1051044|NCT00691704|B1|Baseline|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy~Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.~Maintenance Therapy: Subjects who achieve >partial response (PR) after induction will receive repeating triplet 28-day cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance:~325 mg aspirin for deep vein thrombosis (DVT) prophylaxis~Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8~Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7~Prednisone 60 mg /m2 po daily on Days 1-7~Cycle 3, 6, 9, etc. Lenalidomide 10 mg po daily on Days 1-21."
1051055|NCT00691665|P2|Participant Flow|Fluticasone Propionate Nasal Spray, 50 Mcg|Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
1051056|NCT00691665|P1|Participant Flow|Olopatadine HCL Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
1051057|NCT00691665|O2|Outcome|Fluticasone Propionate Nasal Spray, 50 Mcg|Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
1051045|NCT00691704|P1|Participant Flow|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy~Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.~Sequential Maintenance Therapy: Subjects who achieve >partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance (per discussion with physician):~325 mg aspirin for deep vein thrombosis (DVT) prophylaxis~Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle~Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7~Prednisone 60 mg /m2 po daily on"
1051046|NCT00691704|O1|Outcome|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy~Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.~Sequential Maintenance Therapy: Subjects who achieve >partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance (per discussion with physician):~325 mg aspirin for deep vein thrombosis (DVT) prophylaxis~Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle~Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7~Prednisone 60 mg /m2 po daily on"
1051047|NCT00691704|O1|Outcome|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy~Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.~Sequential Maintenance Therapy: Subjects who achieve >partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance (per discussion with physician):~325 mg aspirin for deep vein thrombosis (DVT) prophylaxis~Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle~Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7~Prednisone 60 mg /m2 po daily on"
1051048|NCT00691704|O1|Outcome|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy~Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.~Sequential Maintenance Therapy: Subjects who achieve >partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance (per discussion with physician):~325 mg aspirin for deep vein thrombosis (DVT) prophylaxis~Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle~Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7~Prednisone 60 mg /m2 po daily on"
1051049|NCT00691704|O1|Outcome|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy~Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.~Sequential Maintenance Therapy: Subjects who achieve >partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance (per discussion with physician):~325 mg aspirin for deep vein thrombosis (DVT) prophylaxis~Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle~Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7~Prednisone 60 mg /m2 po daily on"
1051050|NCT00691704|O1|Outcome|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy~Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.~Sequential Maintenance Therapy: Subjects who achieve >partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance (per discussion with physician):~325 mg aspirin for deep vein thrombosis (DVT) prophylaxis~Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle~Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7~Prednisone 60 mg /m2 po daily on"
1051051|NCT00691704|E1|Reported Event|High-risk Multiple Myeloma|"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy~Lenalidomide Induction: Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.~Sequential Maintenance Therapy: Subjects who achieve >partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved > stable disease (SD) from maintenance (per discussion with physician):~325 mg aspirin for deep vein thrombosis (DVT) prophylaxis~Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle~Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7~Prednisone 60 mg /m2 po daily on"
1051052|NCT00691665|B3|Baseline|Total|Total of all reporting groups
1051053|NCT00691665|B2|Baseline|Fluticasone Propionate Nasal Spray, 50 Mcg|Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
1051054|NCT00691665|B1|Baseline|Olopatadine HCL Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
1051058|NCT00691665|O1|Outcome|Olopatadine HCL Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
1051059|NCT00691665|O2|Outcome|Fluticasone Propionate Nasal Spray, 50 Mcg|Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
1051060|NCT00691665|O1|Outcome|Olopatadine HCL Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
1051061|NCT00691665|O2|Outcome|Fluticasone Propionate Nasal Spray, 50 Mcg|Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
1051062|NCT00691665|O1|Outcome|Olopatadine HCL Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
1051063|NCT00691665|O2|Outcome|Fluticasone Propionate Nasal Spray, 50 Mcg|Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
1051064|NCT00691665|O1|Outcome|Olopatadine HCL Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
1051065|NCT00691665|E2|Reported Event|Fluticasone Propionate Nasal Spray, 50 Mcg|Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily
1051066|NCT00691665|E1|Reported Event|Olopatadine HCL Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
1051067|NCT00691652|B1|Baseline|Oral Clofarabine + Rituximab in Relapsed B Cell NHL|"Phase I: Oral Clofarabine x 14 days for up to 8 cycles at assigned dose level below (1 cycle equals 14 days on drug, 14 days off).~Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV~Dose Level 1: 2 mg Dose Level 2: 4 mg Dose Level 3: 6 mg~Phase II:~Oral Clofarabine x 14 days for up to 8 cycles (Dose determined from phase I) AND Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV"
1051068|NCT00691652|P1|Participant Flow|Oral Clofarabine + Rituximab in Relapsed B Cell NHL|"Phase I: Oral Clofarabine x 14 days for up to 8 cycles at assigned dose level below (1 cycle equals 14 days on drug, 14 days off).~Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV~Dose Level 1: 2 mg Dose Level 2: 4 mg Dose Level 3: 6 mg~Phase II:~Oral Clofarabine x 14 days for up to 8 cycles (Dose determined from phase I) AND Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV"
1051069|NCT00691652|O1|Outcome|Oral Clofarabine + Rituximab in Relapsed B Cell NHL|"Phase I: Oral Clofarabine x 14 days for up to 8 cycles at assigned dose level below (1 cycle equals 14 days on drug, 14 days off).~Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV~Dose Level 1: 2 mg Dose Level 2: 4 mg Dose Level 3: 6 mg~Phase II:~Oral Clofarabine x 14 days for up to 8 cycles (Dose determined from phase I) AND Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV"
1051070|NCT00691652|E1|Reported Event|Oral Clofarabine + Rituximab in Relapsed B Cell NHL|"Phase I: Oral Clofarabine x 14 days for up to 8 cycles at assigned dose level below (1 cycle equals 14 days on drug, 14 days off).~Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV~Dose Level 1: 2 mg Dose Level 2: 4 mg Dose Level 3: 6 mg~Phase II:~Oral Clofarabine x 14 days for up to 8 cycles (Dose determined from phase I) AND Rituximab weekly for 4 weeks than monthly for up to 8 cycles on day 1 of cycle 375 mg/m2 IV"
1051071|NCT00691483|B3|Baseline|Total|Total of all reporting groups
1051072|NCT00691483|B2|Baseline|Placebo|Placebo matched to varenicline.
1051073|NCT00691483|B1|Baseline|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
1051074|NCT00691483|P2|Participant Flow|Placebo|Placebo matched to varenicline.
1051075|NCT00691483|P1|Participant Flow|Varenicline|Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
1051076|NCT00691483|O2|Outcome|Placebo|Placebo matched to varenicline.
1051077|NCT00691483|O1|Outcome|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
1051078|NCT00691483|O2|Outcome|Placebo|Placebo matched to varenicline.
1051079|NCT00691483|O1|Outcome|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
1051080|NCT00691483|O2|Outcome|Placebo|Placebo matched to varenicline.
1051081|NCT00691483|O1|Outcome|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
1051082|NCT00691483|O2|Outcome|Placebo|Placebo matched to varenicline.
1051083|NCT00691483|O1|Outcome|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
1051084|NCT00691483|O2|Outcome|Placebo|Placebo matched to varenicline.
1051085|NCT00691483|O1|Outcome|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
1051086|NCT00691483|O2|Outcome|Placebo|Placebo matched to varenicline.
1051087|NCT00691483|O1|Outcome|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
1051088|NCT00691483|E2|Reported Event|Placebo|Placebo matched to varenicline.
1051089|NCT00691483|E1|Reported Event|Varenicline|Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
1051091|NCT00692692|P2|Participant Flow|Control 2|"muscle over tissue expanders~DermaMatrix : DermaMatrix acellular dermis with tissue expanders after mastectomy or Traditional serratus reconstruction with tissue expanders after mastectomy~muscle coverage over tissue expander : Tissue expander reconstruction"
1051092|NCT00692692|P1|Participant Flow|Experimental 1|"DermaMatrix acellular dermis over tissue expanders~DermaMatrix : DermaMatrix acellular dermis with tissue expanders after mastectomy or Traditional serratus reconstruction with tissue expanders after mastectomy"
1051093|NCT00692692|O2|Outcome|Experimental 1|acellular dermal matrix for total coverage of tissue expander after mastectomy for breast reconstruciton.
1051094|NCT00692692|O1|Outcome|Control 2|"muscle over tissue expanders~DermaMatrix : DermaMatrix acellular dermis with tissue expanders after mastectomy or Traditional serratus reconstruction with tissue expanders after mastectomy~muscle coverage over tissue expander : Tissue expander reconstruction"
1051095|NCT00692692|E2|Reported Event|Control 2|"muscle over tissue expanders~DermaMatrix : DermaMatrix acellular dermis with tissue expanders after mastectomy or Traditional serratus reconstruction with tissue expanders after mastectomy~muscle coverage over tissue expander : Tissue expander reconstruction"
1051096|NCT00692692|E1|Reported Event|Experimental 1|"DermaMatrix acellular dermis over tissue expanders~DermaMatrix : DermaMatrix acellular dermis with tissue expanders after mastectomy or Traditional serratus reconstruction with tissue expanders after mastectomy"
1051097|NCT00692419|B3|Baseline|Total|Total of all reporting groups
1051098|NCT00692419|B2|Baseline|Feedback Intervention|"This arm of the study will have pain, sexual dysfunction and depression assessed monthly with feedback given to renal providers on the presence and severity of these symptoms. Treatment will be left at the discretion of the renal provider~Feedback of Symptoms Intervention: Pain, sexual dysfunction and depression will be assessed monthly and feedback will be given to renal providers on the presence and severity of these symptoms. Treatment will be left at the discretion of the renal provider"
1051099|NCT00692419|B1|Baseline|Symptom Management Intervention|"This arm of the study will have a symptom management nurse facilitate the management of pain, sexual dysfunction and depression~Renal Symptom Management Nurse Practitioner Intervention: A symptom management nurse will facilitate the management of pain, sexual dysfunction and depression in patients enrolled in one arm of the study"
1051100|NCT00692419|P2|Participant Flow|Arm 2|"This arm of the study will have pain, sexual dysfunction and depression assessed monthly with feedback given to renal providers on the presence and severity of these symptoms. Treatment will be left at the discretion of the renal provider~Feedback of Symptoms Intervention: Pain, sexual dysfunction and depression will be assessed monthly and feedback will be given to renal providers on the presence and severity of these symptoms. Treatment will be left at the discretion of the renal provider"
1051101|NCT00692419|P1|Participant Flow|Arm 1|"This arm of the study will have a symptom management nurse facilitate the management of pain, sexual dysfunction and depression~Renal Symptom Management Nurse Practitioner Intervention: A symptom management nurse will facilitate the management of pain, sexual dysfunction and depression in patients enrolled in one arm of the study"
1051102|NCT00692419|O6|Outcome|Feedback Arm Change in Depression Score|Feedback arm change in depression score on the Patient Health Questionnaire 9 (PHQ-9) during the intervention. The PHQ-9 is scored from 1 to 27, with higher scores denoting more severe depression. We considered patients with PHQ-9 scores ≥10 to have depression.
1051103|NCT00692419|O5|Outcome|Management Group - Change in Depression Score|Management group - change in depression score on the Patient Health Questionnaire 9 (PHQ-9) during the intervention. The PHQ-9 is scored from 1 to 27, with higher scores denoting more severe depression. We considered patients with PHQ-9 scores ≥10 to have depression.
1051104|NCT00692419|O4|Outcome|Feedback Group - Change in ED Score|Feedback group - change in ED score on the Sexual Health Inventory for Men (SHIM) questionnaire during the intervention. We scored the SHIM from 5-25 with lower scores denoting more severe ED. We considered patients with SHIM scores <22 to have ED.
1051105|NCT00692419|O3|Outcome|Management Group - Change in ED Score|Management group - change in ED score on the Sexual Health Inventory for Men (SHIM) questionnaire during the intervention. We scored the SHIM from 5-25 with lower scores denoting more severe ED. We considered patients with SHIM scores <22 to have ED.
1051106|NCT00692419|O2|Outcome|Feedback Group - Change in Pain Score|Feedback group - change in pain score of the Short Form McGill Pain Questionnaire (SF-MPQ) during the intervention. The SF-MPQ includes 15 pain descriptors that are rated from 0 (no pain) to 3 (severe pain), with a summary score of 0-45. Higher scores represent more pain.
1051107|NCT00692419|O1|Outcome|Management Arm Change in Pain Score|Management arm change in pain score of the Short Form McGill Pain Questionnaire (SF-MPQ) during the intervention. The SF-MPQ includes 15 pain descriptors that are rated from 0 (no pain) to 3 (severe pain), with a summary score of 0-45. Higher scores represent more pain.
1051108|NCT00692419|E2|Reported Event|Arm 2|"This arm of the study will have pain, sexual dysfunction and depression assessed monthly with feedback given to renal providers on the presence and severity of these symptoms. Treatment will be left at the discretion of the renal provider~Feedback of Symptoms Intervention: Pain, sexual dysfunction and depression will be assessed monthly and feedback will be given to renal providers on the presence and severity of these symptoms. Treatment will be left at the discretion of the renal provider"
1051109|NCT00692419|E1|Reported Event|Arm 1|"This arm of the study will have a symptom management nurse facilitate the management of pain, sexual dysfunction and depression~Renal Symptom Management Nurse Practitioner Intervention: A symptom management nurse will facilitate the management of pain, sexual dysfunction and depression in patients enrolled in one arm of the study"
1051110|NCT00692406|B1|Baseline|Smokers Not Interested in Quitting|Smokers were scanned twice, once following smoking as usual and once following 24 hrs smoking abstinence
1051111|NCT00692406|P1|Participant Flow|Smokers Not Interested in Quitting|Smokers were scanned twice, once following smoking as usual and once following 24 hrs smoking abstinence
1051112|NCT00692406|O1|Outcome|Smokers Not Interested in Quitting|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
1051113|NCT00692406|O1|Outcome|Smokers Not Interested in Quitting|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
1051114|NCT00692406|O1|Outcome|Smokers Not Interested in Quitting|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
1051115|NCT00692406|O1|Outcome|Smokers Not Interested in Quitting|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
1051116|NCT00692406|O1|Outcome|Smokers Not Interested in Quitting|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
1051117|NCT00692406|O1|Outcome|Smokers Not Interested in Quitting|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
1051118|NCT00692406|O1|Outcome|Smokers Not Interested in Quitting|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
1051119|NCT00692406|O1|Outcome|Smokers Not Interested in Quitting|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
1051120|NCT00692406|E1|Reported Event|Smokers Not Interested in Quitting|Smokers were scanned twice, once following smoking as usual and once following 24 hrs smoking abstinence
1051121|NCT00692341|B4|Baseline|Total|Total of all reporting groups
1051122|NCT00692341|B3|Baseline|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
1051123|NCT00692341|B2|Baseline|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
1051124|NCT00692341|B1|Baseline|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
1051125|NCT00692341|P3|Participant Flow|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
1051126|NCT00692341|P2|Participant Flow|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
1051127|NCT00692341|P1|Participant Flow|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
1051128|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
1051129|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
1051130|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
1051131|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
1051132|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
1051133|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
1051134|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
1051277|NCT00691938|E3|Reported Event|Level 3|"LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
1051287|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
1051135|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
1051136|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
1051137|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
1051138|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
1051139|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
1051140|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
1051141|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
1051142|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
1051143|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
1051144|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
1051145|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
1051146|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
1051147|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
1051148|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
1051149|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
1051150|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
1051151|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
1051288|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
1051152|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
1051153|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
1051154|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
1051155|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
1051156|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
1051157|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
1051158|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
1051159|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
1051160|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
1051161|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
1051162|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
1051163|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
1051164|NCT00692341|O3|Outcome|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
1051165|NCT00692341|O2|Outcome|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
1051166|NCT00692341|O1|Outcome|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
1051167|NCT00692341|E3|Reported Event|Axitinib : Moderate Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with moderate hepatic impairment. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time INR, ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total moderate hepatic impairment score range is 5 (mild) to 15 (severe).
1051278|NCT00691938|E2|Reported Event|Level 2|"LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
1051289|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
1051168|NCT00692341|E2|Reported Event|Axitinib : Mild Hepatic Impairment|Single oral dose of axitinib (AG-013736) 5 mg IRT on Day 1 to participants with mild hepatic impairment. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time or prothrombin time international normalized ratio [INR], ascites and encephalopathy grade) on a scale of 1 (mild or none) to 3 (most severe). Total mild hepatic impairment score range is 5 (mild) to 15 (severe).
1051169|NCT00692341|E1|Reported Event|Axitinib : Normal Hepatic Function|Single oral dose of axitinib (AG-013736) 5 milligrams (mg) immediate release tablets (IRT) on Day 1 to participants with normal hepatic function.
1051170|NCT00692237|B3|Baseline|Total|Total of all reporting groups
1051171|NCT00692237|B2|Baseline|Placebo|Placebo 100 mg/day (50 + 25 + 25)
1051172|NCT00692237|B1|Baseline|Sildenafil|Sildenafil citrate 100 mg/day (50+25+25)
1051173|NCT00692237|P2|Participant Flow|Placebo|Placebo 100 mg/day (50 + 25 + 25)
1051174|NCT00692237|P1|Participant Flow|Sildenafil|Sildenafil citrate 100 mg/day (50+25+25)
1051175|NCT00692237|O2|Outcome|Placebo|Patients randomized to receive placebo were instructed to take 3 capsules per day (1 at 8.00 a.m. + 1 at 4.00 p.m. + 1 at 10.00 p.m.) that were identical-looking to sildenafil capsules, for a duration of 3 months (12 weeks). The allocation list was produced using dedicated software by permuted-block randomization with 1:1 allocation using randomly sized blocks (4 to 8). The study was double-blinded.
1051176|NCT00692237|O1|Outcome|Sildenafil|Patients randomized to receive sildenafil were instructed to take 3 capsules per day (25 mg at 8.00 a.m. + 25 mg at 4.00 p.m. + 50 mg at 10.00 p.m.) that were identical-looking to placebo capsules, for a duration of 3 months (12 weeks). The allocation list was produced using dedicated software by permuted-block randomization with 1:1 allocation using randomly sized blocks (4 to 8). The study was double-blinded.
1051177|NCT00692237|O2|Outcome|Placebo|Patients randomized to receive placebo were instructed to take 3 capsules per day (1 at 8.00 a.m. + 1 at 4.00 p.m. + 1 at 10.00 p.m.) that were identical-looking to sildenafil capsules, for a duration of 3 months (12 weeks). The allocation list was produced using dedicated software by permuted-block randomization with 1:1 allocation using randomly sized blocks (4 to 8). The study was double-blinded.
1051178|NCT00692237|O1|Outcome|Sildenafil|Patients randomized to receive sildenafil were instructed to take 3 capsules per day (25 mg at 8.00 a.m. + 25 mg at 4.00 p.m. + 50 mg at 10.00 p.m.) that were identical-looking to placebo capsules, for a duration of 3 months (12 weeks). The allocation list was produced using dedicated software by permuted-block randomization with 1:1 allocation using randomly sized blocks (4 to 8). The study was double-blinded.
1051179|NCT00692237|E2|Reported Event|Placebo|Placebo 100 mg/day (50 + 25 + 25)
1051180|NCT00692237|E1|Reported Event|Sildenafil|Sildenafil citrate 100 mg/day (50+25+25)
1051181|NCT00692211|B3|Baseline|Total|Total of all reporting groups
1051182|NCT00692211|B2|Baseline|Arm 2: Fecal Occult Blood Tests|"Mailed fecal occult blood tests~Fecal occult blood test: Stool blood test"
1051183|NCT00692211|B1|Baseline|Arm 1: Fecal Immunochemical Tests|"Mailed fecal immunochemical tests~Fecal immunochemical testing: Stool blood test"
1051184|NCT00692211|P2|Participant Flow|Arm 2: Fecal Occult Blood Tests|"Mailed fecal occult blood tests~Fecal occult blood test: Stool blood test"
1051185|NCT00692211|P1|Participant Flow|Arm 1: Fecal Immunochemical Tests|"Mailed fecal immunochemical tests~Fecal immunochemical testing: Stool blood test"
1051186|NCT00692211|O2|Outcome|Arm 2: Fecal Occult Blood Tests|"Mailed fecal occult blood tests~Fecal occult blood test: Stool blood test"
1051187|NCT00692211|O1|Outcome|Arm 1: Fecal Immunochemical Tests|"Mailed fecal immunochemical tests~Fecal immunochemical testing: Stool blood test"
1051188|NCT00692211|E2|Reported Event|Arm 2: Fecal Occult Blood Tests|"Mailed fecal occult blood tests~Fecal occult blood test: Stool blood test"
1051189|NCT00692211|E1|Reported Event|Arm 1: Fecal Immunochemical Tests|"Mailed fecal immunochemical tests~Fecal immunochemical testing: Stool blood test"
1051190|NCT00692198|B3|Baseline|Total|Total of all reporting groups
1051191|NCT00692198|B2|Baseline|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest).
1051192|NCT00692198|B1|Baseline|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
1051193|NCT00692198|P2|Participant Flow|No Supplemental Oxygen Therapy (No LTOT)|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
1051194|NCT00692198|P1|Participant Flow|Supplemental Oxygen Therapy (LTOT)|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
1051195|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
1051279|NCT00691938|E1|Reported Event|Level 1|"LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
1051280|NCT00691808|B4|Baseline|Total|Total of all reporting groups
1051281|NCT00691808|B3|Baseline|Placebo|Placebo dosing volume-matched and administered once per day
1051196|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
1051197|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
1051198|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
1051199|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
1051200|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
1051201|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
1051202|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
1051203|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
1051204|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
1051205|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
1051206|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
1051207|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
1051208|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
1051209|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
1051282|NCT00691808|B2|Baseline|Low Dose|120 mg LX6171 oral suspension administered once per day
1051283|NCT00691808|B1|Baseline|High Dose|240 mg LX6171 oral suspension administered once per day
1051210|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
1051211|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
1051212|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
1051213|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
1051214|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
1051215|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
1051216|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
1051217|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
1051218|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
1051219|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
1051220|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
1051221|NCT00692198|O2|Outcome|No Supplemental Oxygen Therapy|Participants will receive no supplemental oxygen therapy, unless the participant becomes severely hypoxemic at rest (e.g., meets conventional Medicare criteria for 24-hour supplemental oxygen due to severe hypoxemia at rest) or during exercise (SpO2 below 80% for at least 1 minute during 6 minute walk).
1051222|NCT00692198|O1|Outcome|Supplemental Oxygen Therapy|"Participants will receive treatment with supplemental oxygen therapy.~Supplemental oxygen therapy: Oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep."
1051223|NCT00692198|E3|Reported Event|No Supplemental Oxygen|Participants in the No supplemental oxygen who did not receive home oxygen during their participation in the trial.
1051224|NCT00692198|E2|Reported Event|Patients Crossing Over to Supplemental Oxygen Therapy|Participants in the No supplemental oxygen therapy group who receive supplemental oxygen therapy during their participation in the trial due to prescription of supplemental oxygen outside the trial or development of severe resting or exercise hypoxemia
1051284|NCT00691808|P3|Participant Flow|Placebo|Placebo dosing volume-matched and administered once per day
1051225|NCT00692198|E1|Reported Event|Supplemental Oxygen Therapy|Participants will receive treatment with supplemental oxygen therapy. Supplemental oxygen therapy: oxygen dose at rest and during sleep will be 2 L/min via nasal cannula. The oxygen dose used while walking will be individually prescribed and will be sufficient to maintain oxygen saturation at 90% or above for at least 2 minutes while walking. Participants who have low blood oxygen levels at rest will be instructed to use oxygen 24 hours per day. Participants who have normal resting blood oxygen levels, but low or very low blood oxygen levels during exercise, will be instructed to use oxygen during physical activity and sleep.
1051226|NCT00692185|B3|Baseline|Total|Total of all reporting groups
1051227|NCT00692185|B2|Baseline|Placebo|Participants will take matched placebo for 16 weeks.
1051228|NCT00692185|B1|Baseline|Olanzapine|Dosing of olanzapine began at 2.5 mg daily and was increased every two weeks, first to 5 mg, then 10 mg if the patient was tolerating the medication. If side effects were significant, dosage of the study medication could be lowered. All subjects recieved 16 weeks of assigned medication.
1051229|NCT00692185|P2|Participant Flow|Placebo|Participants will take matched placebo for 16 weeks.
1051230|NCT00692185|P1|Participant Flow|Olanzapine|Dosing of olanzapine began at 2.5 mg daily and was increased every two weeks, first to 5 mg, then 10 mg if the patient was tolerating the medication. If side effects were significant, dosage of the study medication could be lowered. All subjects recieved 16 weeks of assigned medication.
1051231|NCT00692185|O2|Outcome|Placebo|Participants will take matched placebo for 16 weeks.
1051232|NCT00692185|O1|Outcome|Olanzapine|Dosing of olanzapine began at 2.5 mg daily and was increased every two weeks, first to 5 mg, then 10 mg if the patient was tolerating the medication. If side effects were significant, dosage of the study medication could be lowered. All subjects recieved 16 weeks of assigned medication.
1051233|NCT00692185|E2|Reported Event|Placebo|Participants will take matched placebo for 16 weeks.
1051234|NCT00692185|E1|Reported Event|Olanzapine|Dosing of olanzapine began at 2.5 mg daily and was increased every two weeks, first to 5 mg, then 10 mg if the patient was tolerating the medication. If side effects were significant, dosage of the study medication could be lowered. All subjects recieved 16 weeks of assigned medication.
1051235|NCT00692003|B3|Baseline|Total|Total of all reporting groups
1051236|NCT00692003|B2|Baseline|Placebo|"25-400 mg Zonisamide Placebo capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo; >= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
1051237|NCT00692003|B1|Baseline|Zonisamide|"25-400 mg capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg;~>= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained(4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
1051238|NCT00692003|P2|Participant Flow|Placebo|"25-400 mg Zonisamide Placebo capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo;~>= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
1051239|NCT00692003|P1|Participant Flow|Zonisamide|"25-400 mg capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg;~>= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
1051240|NCT00692003|O2|Outcome|Placebo|"25-400 mg Zonisamide Placebo capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo; >= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
1051241|NCT00692003|O1|Outcome|Zonisamide|"25-400 mg capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg;~>= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained(4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
1051242|NCT00692003|O2|Outcome|Placebo|"25-400 mg Zonisamide Placebo capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo; >= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
1051243|NCT00692003|O1|Outcome|Zonisamide|"25-400 mg capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg;~>= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained(4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
1051244|NCT00692003|E2|Reported Event|Zonisamide|"25-400 mg capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg; >= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
1051245|NCT00692003|E1|Reported Event|Placebo|"25-400 mg Zonisamide Placebo capsules orally once daily in the evening.~Maximum study duration of 28 weeks comprising:~Baseline Period (Week-8/-4 to Week 0) no treatment~Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo; >= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4~Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)~Down Titration Period (4 weeks)"
1051246|NCT00691938|B8|Baseline|Total|Total of all reporting groups
1051247|NCT00691938|B7|Baseline|Phase II|"LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
1051248|NCT00691938|B6|Baseline|Level 5B|"LBH589 40 mg/day three times a week on nonconsecutive days for the first 2 weeks in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
1051249|NCT00691938|B5|Baseline|Level 5|"LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
1051250|NCT00691938|B4|Baseline|Level 4|"LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
1051251|NCT00691938|B3|Baseline|Level 3|"LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
1051252|NCT00691938|B2|Baseline|Level 2|"LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
1051253|NCT00691938|B1|Baseline|Level 1|"LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
1051254|NCT00691938|P7|Participant Flow|Phase II|"LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
1051255|NCT00691938|P6|Participant Flow|Level 5B|"LBH589 40 mg/day three times a week on nonconsecutive days for the first 2 weeks in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
1051256|NCT00691938|P5|Participant Flow|Level 5|"LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
1051257|NCT00691938|P4|Participant Flow|Level 4|"LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
1051258|NCT00691938|P3|Participant Flow|Level 3|"LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
1051259|NCT00691938|P2|Participant Flow|Level 2|"LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
1051260|NCT00691938|P1|Participant Flow|Level 1|"LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
1051261|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
1051262|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
1051263|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
1051264|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
1051285|NCT00691808|P2|Participant Flow|Low Dose|120 mg LX6171 oral suspension administered once per day
1051286|NCT00691808|P1|Participant Flow|High Dose|240 mg LX6171 oral suspension administered once per day
1051265|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
1051266|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
1051267|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
1051268|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
1051269|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
1051270|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
1051271|NCT00691938|O1|Outcome|Level 1-Phase II (All Patients Enrolled)|"Level 1:LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 2:LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 4:LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5:LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle.~Level 5B/Phase II:LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle."
1051272|NCT00691938|O1|Outcome|Phase I (Includes Levels 1-5)|
1051273|NCT00691938|E7|Reported Event|Phase II|"LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was dose from Level 5B.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
1051274|NCT00691938|E6|Reported Event|Level 5B|"LBH589 40 mg/day three times a week on nonconsecutive days for the first 2 weeks in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
1051275|NCT00691938|E5|Reported Event|Level 5|"LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
1051276|NCT00691938|E4|Reported Event|Level 4|"LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle.~Decitabine 20 mg/m2 IV on days 1-5 in a 28 day cycle."
1051291|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
1051292|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
1051293|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
1051294|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
1051295|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
1051296|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
1051297|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
1051298|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
1051299|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
1051300|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
1051301|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
1051302|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
1051303|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
1051304|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
1051305|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
1051306|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
1051307|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
1051308|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
1051309|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
1051310|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
1051311|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
1051312|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
1051313|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
1051314|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
1051315|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
1051316|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
1051317|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
1051318|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
1051319|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
1051320|NCT00691808|O3|Outcome|Placebo|Placebo dosing volume-matched and administered once per day
1051321|NCT00691808|O2|Outcome|Low Dose|120 mg LX6171 oral suspension administered once per day
1051322|NCT00691808|O1|Outcome|High Dose|240 mg LX6171 oral suspension administered once per day
1051323|NCT00691808|E3|Reported Event|Placebo|Placebo dosing volume-matched and administered once per day
1051324|NCT00691808|E2|Reported Event|Low Dose|120 mg LX6171 oral suspension administered once per day
1051325|NCT00691808|E1|Reported Event|High Dose|240 mg LX6171 oral suspension administered once per day
1051326|NCT00691327|B3|Baseline|Total|Total of all reporting groups
1051327|NCT00691327|B2|Baseline|Revision|Women who have undergone Revision of a Breast Augmentation or Reconstruction
1051328|NCT00691327|B1|Baseline|Reconstruction|Women who have undergone Breast Reconstruction
1051329|NCT00691327|P2|Participant Flow|Revision|Women who have undergone Revision of a Breast Augmentation or Reconstruction
1051330|NCT00691327|P1|Participant Flow|Reconstruction|Women who have undergone Breast Reconstruction
1051331|NCT00691327|O2|Outcome|Revision|Women who have undergone Revision of a Breast Augmentation or Reconstruction
1051332|NCT00691327|O1|Outcome|Reconstruction|Women who have undergone Breast Reconstruction
1051333|NCT00691327|O2|Outcome|Revision|Women who have undergone Revision of a Breast Augmentation or Reconstruction
1051334|NCT00691327|O1|Outcome|Reconstruction|Women who have undergone Breast Reconstruction
1051335|NCT00691327|E2|Reported Event|Revision|Women who have undergone Revision of a Breast Augmentation or Reconstruction
1051336|NCT00691327|E1|Reported Event|Reconstruction|Women who have undergone Breast Reconstruction
1051337|NCT00691210|B9|Baseline|Total|Total of all reporting groups
1051338|NCT00691210|B8|Baseline|V/N/E: Level 3|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 100 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
1051339|NCT00691210|B7|Baseline|V/N/E: Level 2|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
1051340|NCT00691210|B6|Baseline|V/N/E: Level 1|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
1051341|NCT00691210|B5|Baseline|V/N: Level 5|"Vorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
1051342|NCT00691210|B4|Baseline|V/N: Level 4|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
1051343|NCT00691210|B3|Baseline|V/N: Level 3|"Vorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
1051344|NCT00691210|B2|Baseline|V/N: Level 1|"Vorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
1051345|NCT00691210|B1|Baseline|V/N: Level 2|"Vorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
1051346|NCT00691210|P8|Participant Flow|V/N/E: Level 3|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 100 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
1051347|NCT00691210|P7|Participant Flow|V/N/E: Level 2|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
1051423|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
1051348|NCT00691210|P6|Participant Flow|V/N/E: Level 1|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
1051349|NCT00691210|P5|Participant Flow|V/N: Level 5|"Vorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
1051350|NCT00691210|P4|Participant Flow|V/N: Level 4|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
1051351|NCT00691210|P3|Participant Flow|V/N: Level 3|"Vorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
1051352|NCT00691210|P2|Participant Flow|V/N: Level 1|"Vorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
1051353|NCT00691210|P1|Participant Flow|V/N: Level 2|"Vorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
1051354|NCT00691210|O2|Outcome|Vorinostat, Niacinamide and Etoposide: Level 1-2|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25-50 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
1051355|NCT00691210|O1|Outcome|Vorinostat (SAHA) and Niacinamide: Level 1-5|"Vorinostat: 400mg Niacinamide: 20-100 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
1051356|NCT00691210|O7|Outcome|Vorinostat, Niacinamide and Etoposide: Level 2|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
1051357|NCT00691210|O6|Outcome|Vorinostat, Niacinamide and Etoposide: Level 1|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
1051358|NCT00691210|O5|Outcome|Vorinostat (SAHA) and Niacinamide: Level 5|"Vorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
1051359|NCT00691210|O4|Outcome|Vorinostat (SAHA) and Niacinamide: Level 4|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
1051360|NCT00691210|O3|Outcome|Vorinostat (SAHA) and Niacinamide: Level 3|"Vorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
1051361|NCT00691210|O2|Outcome|Vorinostat (SAHA) and Niacinamide: Level 2|"Vorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
1051362|NCT00691210|O1|Outcome|Vorinostat (SAHA) and Niacinamide: Level 1|"Vorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
1051363|NCT00691210|E7|Reported Event|Vorinostat, Niacinamide and Etoposide: Level 2|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
1051364|NCT00691210|E6|Reported Event|Vorinostat, Niacinamide and Etoposide: Level 1|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2~Vorinostat, Niacinamide and Etoposide: dose escalation scheme"
1051365|NCT00691210|E5|Reported Event|Vorinostat (SAHA) and Niacinamide: Level 5|"Vorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
1051366|NCT00691210|E4|Reported Event|Vorinostat (SAHA) and Niacinamide: Level 4|"Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
1051367|NCT00691210|E3|Reported Event|Vorinostat (SAHA) and Niacinamide: Level 3|"Vorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
1051368|NCT00691210|E2|Reported Event|Vorinostat (SAHA) and Niacinamide: Level 2|"Vorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
1051369|NCT00691210|E1|Reported Event|Vorinostat (SAHA) and Niacinamide: Level 1|"Vorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg~Vorinostat (SAHA) and Niacinamide: dose escalation scheme"
1051370|NCT00691197|B3|Baseline|Total|Total of all reporting groups
1051371|NCT00691197|B2|Baseline|Carboxymethylcellulose Sodium|Carboxymethylcellulose sodium based rewetting drop
1051372|NCT00691197|B1|Baseline|Carboxymethylcellulose Sodium and Glycerin|Carboxymethylcellulose sodium and Glycerin based rewetting drop
1051373|NCT00691197|P2|Participant Flow|Carboxymethylcellulose Sodium|Carboxymethylcellulose sodium based rewetting drop
1051374|NCT00691197|P1|Participant Flow|Carboxymethylcellulose Sodium and Glycerin|Carboxymethylcellulose sodium and Glycerin based rewetting drop
1051375|NCT00691197|O2|Outcome|Carboxymethylcellulose Sodium|Carboxymethylcellulose sodium based rewetting drop
1051376|NCT00691197|O1|Outcome|Carboxymethylcellulose Sodium and Glycerin|Carboxymethylcellulose sodium and Glycerin based rewetting drop
1051377|NCT00691197|O2|Outcome|Carboxymethylcellulose Sodium|Carboxymethylcellulose sodium based rewetting drop
1051378|NCT00691197|O1|Outcome|Carboxymethylcellulose Sodium and Glycerin|Carboxymethylcellulose sodium and Glycerin based rewetting drop
1051379|NCT00691197|O2|Outcome|Carboxymethylcellulose Sodium|Carboxymethylcellulose sodium based rewetting drop
1051380|NCT00691197|O1|Outcome|Carboxymethylcellulose Sodium and Glycerin|Carboxymethylcellulose sodium and Glycerin based rewetting drop
1051381|NCT00691197|O2|Outcome|Carboxymethylcellulose Sodium|Carboxymethylcellulose sodium based rewetting drop
1051382|NCT00691197|O1|Outcome|Carboxymethylcellulose Sodium and Glycerin|Carboxymethylcellulose sodium and Glycerin based rewetting drop
1051383|NCT00691197|E2|Reported Event|Carboxymethylcellulose Sodium|Carboxymethylcellulose sodium based rewetting drop
1051384|NCT00691197|E1|Reported Event|Carboxymethylcellulose Sodium and Glycerin|Carboxymethylcellulose sodium and Glycerin based rewetting drop
1051385|NCT00691132|B3|Baseline|Total|Total of all reporting groups
1051386|NCT00691132|B2|Baseline|Placebo - PEITC (Short-term Trial)|"Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month. Participants receive oral placebo four times daily for 5 days in week 2 and oral PEITC four times daily for 5 days in week 4. Participants are also asked to smoke only deuterated NNK cigarettes, record the number of cigarettes smoked and alcoholic drinks consumed each day, and keep a food and beverage diary as in arm I.~phenethyl isothiocyanate: Given orally~placebo: Given orally"
1051420|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
1051421|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
1051387|NCT00691132|B1|Baseline|PEITC - Placebo (Short-term Trial)|"Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month. Participants receive oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in week 2 and oral placebo four times daily for 5 days in week 4. Participants keep a diary of all food and beverages consumed on the days that PEITC or placebo are taken.~phenethyl isothiocyanate: Given orally~placebo: Given orally"
1051388|NCT00691132|P2|Participant Flow|Placebo - PEITC (Short-term Trial)|"Participants receive oral placebo four times daily for 5 days in week 2 and oral PEITC four times daily for 5 days in week 4. Participants are also asked to smoke only deuterated NNK cigarettes, record the number of cigarettes smoked and alcoholic drinks consumed each day, and keep a food and beverage diary as in arm I.~phenethyl isothiocyanate: Given orally~placebo: Given orally"
1051389|NCT00691132|P1|Participant Flow|PEITC - Placebo (Short-term Trial)|"Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month. Participants receive oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in week 2 and oral placebo four times daily for 5 days in week 4. Participants keep a diary of all food and beverages consumed on the days that PEITC or placebo are taken.~phenethyl isothiocyanate: Given orally~placebo: Given orally"
1051390|NCT00691132|O3|Outcome|GSTM1 and GSTT1 Both Genes Present|GSTM1 and GSTT1 Present: at least one allele positive for both glutathione-S-transferase (GST) M1 and T1, leading to higher enzymatic activity.
1051391|NCT00691132|O2|Outcome|GSTM1 and GSTT1 Only One Gene Present|GSTM1 or GSTT1 Present: at least one allele positive for either the gene for glutathione-S-transferase (GST) M1 or T1, but not or both genes, leading to moderate enzymatic activity.
1051392|NCT00691132|O1|Outcome|GSTM1 and GSTT1 Both Genes Null|GSTM1 & GSTT1 Null: genes for glutathione-S-transferase (GST) M1 & T1, the homozygous deletion of both genes (GSTM1 null and GSTT1 null), leading to a lack of corresponding enzymatic activity.
1051393|NCT00691132|O3|Outcome|GSTM1 and GSTT1 Both Genes Present|GSTM1 and GSTT1 Present: at least one allele positive for both glutathione-S-transferase (GST) M1 and T1, leading to higher enzymatic activity.
1051394|NCT00691132|O2|Outcome|GSTM1 and GSTT1 Only One Gene Present|GSTM1 or GSTT1 Present: at least one allele positive for either the gene for glutathione-S-transferase (GST) M1 or T1, but not or both genes, leading to moderate enzymatic activity.
1051395|NCT00691132|O1|Outcome|GSTM1 and GSTT1 Both Genes Null|GSTM1 & GSTT1 Null: genes for glutathione-S-transferase (GST) M1 & T1, the homozygous deletion of both genes (GSTM1 null and GSTT1 null), leading to a lack of corresponding enzymatic activity.
1051396|NCT00691132|O2|Outcome|GSTT1 Present|GSTT1 Present: gene for glutathione-S-transferase (GST) T1 (GSTT1), present in one or both alleles, leading to a enzymatic activity.
1051397|NCT00691132|O1|Outcome|GSTT1 Null|GSTT1 Null: gene for glutathione-S-transferase (GST) T1 (GSTT1), the homozygous deletion of the gene (GSTT1 null), leading to a lack of corresponding enzymatic activity.
1051398|NCT00691132|O2|Outcome|GSTM1 Present|GSTM1 Present: gene for glutathione-S-transferase (GST) M1 (GSTM1), present in one or both alleles, leading to a enzymatic activity.
1051399|NCT00691132|O1|Outcome|GSTM1 Null|GSTM1 Null: gene for glutathione-S-transferase (GST) M1 (GSTM1), the homozygous deletion of the gene (GSTM1 null), leading to a lack of corresponding enzymatic activity.
1051400|NCT00691132|O2|Outcome|PEITC|Participants receive oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in either Period 1 or Period 2.
1051401|NCT00691132|O1|Outcome|Placebo|Participants receive oral placebo four times daily for 5 days in either Period 1 or Period 2.
1051402|NCT00691132|O2|Outcome|Placebo - PEITC|Participants receive oral placebo four times daily for 5 days in Period 1 and oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in Period 2, with washout period in between. Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month.
1051403|NCT00691132|O1|Outcome|PEITC-Placebo|Participants receive oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in Period 1 and oral placebo four times daily for 5 days in Period 2, with washout period in between. Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month.
1051404|NCT00691132|E3|Reported Event|PEITC (Short-term Trial)|"Participants receive oral placebo four times daily for 5 days in week 2 and oral PEITC four times daily for 5 days in week 4. Participants are also asked to smoke only deuterated NNK cigarettes, record the number of cigarettes smoked and alcoholic drinks consumed each day, and keep a food and beverage diary as in arm I.~phenethyl isothiocyanate: Given orally~placebo: Given orally"
1051405|NCT00691132|E2|Reported Event|Washout|9 days between treatments
1051406|NCT00691132|E1|Reported Event|Placebo (Short-term Trial)|"Participants are asked to smoke only deuterated NNK cigarettes (provided by the study) and record the exact number of cigarettes smoked and alcoholic drinks consumed each day for 1 month. Participants receive oral phenethyl isothiocyanate (PEITC) four times daily for 5 days in week 2 and oral placebo four times daily for 5 days in week 4. Participants keep a diary of all food and beverages consumed on the days that PEITC or placebo are taken.~phenethyl isothiocyanate: Given orally~placebo: Given orally"
1051407|NCT00691093|B1|Baseline|Fesoterodine 4 mg|The recommended starting dose was 4 mg once daily. Based upon individual response, the dose was increased to 8 mg once daily.
1051408|NCT00691093|P1|Participant Flow|Fesoterodine 4 mg or 8 mg|The recommended starting dose was 4 mg once daily. Based upon individual response, the dose was increased to 8 mg once daily.
1051409|NCT00691093|O1|Outcome|All Subjects|Fesoterodine 4 mg or 8 mg
1051410|NCT00691093|O1|Outcome|All Subjects|Fesoterodine 4 or 8 mg
1051411|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
1051412|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
1051413|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
1051414|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
1051415|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
1051416|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
1051417|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
1051418|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
1051419|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
1051426|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
1051427|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
1051428|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
1051429|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
1051430|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
1051431|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
1051432|NCT00691093|O1|Outcome|All Subjects|The recommended starting dose was 4 mg once daily. Based upon individual response, the dose was increased to 8 mg once daily.
1051433|NCT00691093|O1|Outcome|All Subjects|Fesoterodine 4 or 8 mg
1051434|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
1051435|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
1051436|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
1051437|NCT00691093|O3|Outcome|Increase of Dose From 4 mg to 8 mg Due to Lack of Efficacy|
1051438|NCT00691093|O2|Outcome|Fesoterodine 8 mg|
1051439|NCT00691093|O1|Outcome|Fesoterodine 4 mg|
1051440|NCT00691093|E1|Reported Event|Fesoterodine 4 mg or 8 mg|All Subjects
1051441|NCT00691054|B1|Baseline|Abraxane|Abraxane : One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
1051442|NCT00691054|P1|Participant Flow|Abraxane|One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
1051443|NCT00691054|O1|Outcome|Abraxane|One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
1051444|NCT00691054|O1|Outcome|Abraxane|One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
1051445|NCT00691054|O1|Outcome|Abraxane|One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
1051446|NCT00691054|O1|Outcome|Single Arm|Abraxane : One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
1051447|NCT00691054|O1|Outcome|Abraxane|One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4.
1051448|NCT00691054|O1|Outcome|Abraxane|One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
1051449|NCT00691054|E1|Reported Event|Abraxane|Abraxane : One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
1051450|NCT00691028|B4|Baseline|Total|Total of all reporting groups
1051451|NCT00691028|B3|Baseline|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
1051452|NCT00691028|B2|Baseline|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
1051453|NCT00691028|B1|Baseline|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
1051454|NCT00691028|P4|Participant Flow|Open-label|327 patients received TA-650 at 3 mg/kg treatment during the open-label period.
1051455|NCT00691028|P3|Participant Flow|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
1051456|NCT00691028|P2|Participant Flow|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
1051457|NCT00691028|P1|Participant Flow|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
1051458|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
1051459|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
1051460|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
1051461|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
1051462|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
1051463|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
1051464|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
1051465|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
1051466|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
1051467|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
1051468|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
1051469|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14..
1051470|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
1051471|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14..
1051472|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
1051473|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14..
1051474|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
1051475|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
1051476|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
1051477|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
1051478|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
1051479|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
1051480|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
1051481|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
1051482|NCT00691028|O3|Outcome|TA-650 10 mg/kg|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
1051483|NCT00691028|O2|Outcome|TA-650 6 mg/kg|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
1051484|NCT00691028|O1|Outcome|TA-650 3 mg/kg|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
1051485|NCT00691028|E4|Reported Event|Open-label|327 patients received TA-650 at 3 mg/kg treatment during the open-label period.
1051486|NCT00691028|E3|Reported Event|TA-650 10 mg/kg (Double-blind)|104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
1051487|NCT00691028|E2|Reported Event|TA-650 6 mg/kg (Double-blind)|104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
1051488|NCT00691028|E1|Reported Event|TA-650 3 mg/kg (Double-blind)|99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
1051489|NCT00690898|B1|Baseline|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
1051490|NCT00690898|P1|Participant Flow|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
1051491|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
1051492|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
1051493|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
1051494|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
1051495|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
1051496|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
1051497|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
1051498|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
1051499|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
1051500|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
1051501|NCT00690898|O1|Outcome|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
1051502|NCT00690898|E1|Reported Event|Lanreotide Autogel 120 mg|One Lanreotide Autogel subcutaneous (s.c.) injection administered every 28 days for 12 courses as primary medical treatment in newly diagnosed acromegaly patients with pituitary tumour.
1051503|NCT00690833|B1|Baseline|Topical Desonide Hydrogel 0.05%|"Approximately 40 male and female subjects (about 20 age 3 months to <13 years and 20 age 13 and up) with mild to moderate atopic dermatitis will apply desonate gel twice daily to ATD~topical desonide hydrogel 0.05%: apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions"
1051504|NCT00690833|P1|Participant Flow|Topical Desonide Hydrogel 0.05%|"Approximately 40 male and female subjects (about 20 age 3 months to <13 years and 20 age 13 and up) with mild to moderate atopic dermatitis will apply desonate gel twice daily to ATD~topical desonide hydrogel 0.05%: apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions"
1051712|NCT00689871|P1|Participant Flow|Primary Augmentation|All women implanted for an indication of primary breast augmentation
1051505|NCT00690833|O1|Outcome|Topical Desonide Hydrogel 0.05%|"Approximately 40 male and female subjects (about 20 age 3 months to <13 years and 20 age 13 and up) with mild to moderate atopic dermatitis will apply desonate gel twice daily to ATD~topical desonide hydrogel 0.05%: apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions"
1051506|NCT00690833|E1|Reported Event|Topical Desonide Hydrogel 0.05%|"Approximately 40 male and female subjects (about 20 age 3 months to <13 years and 20 age 13 and up) with mild to moderate atopic dermatitis will apply desonate gel twice daily to ATD~topical desonide hydrogel 0.05%: apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions"
1051507|NCT00690820|B3|Baseline|Total|Total of all reporting groups
1051508|NCT00690820|B2|Baseline|Pancrelipase/Placebo|Pancrelipase delayed release 12000 units period followed by Placebo period
1051509|NCT00690820|B1|Baseline|Placebo/Pancrelipase|Placebo period followed by Pancrelipase delayed release 12000 units period
1051510|NCT00690820|P2|Participant Flow|Pancrelipase/Placebo|Pancrelipase delayed release 12000 units period followed by Placebo period
1051511|NCT00690820|P1|Participant Flow|Placebo/Pancrelipase|Placebo period followed by Pancrelipase delayed release 12000 units period
1051512|NCT00690820|O2|Outcome|Pancrelipase|Pancrelipase delayed release 12000 units treatment
1051513|NCT00690820|O1|Outcome|Placebo|Placebo treatment
1051514|NCT00690820|O2|Outcome|Pancrelipase|Pancrelipase delayed release 12000 units treatment
1051515|NCT00690820|O1|Outcome|Placebo|Placebo treatment
1051516|NCT00690820|O2|Outcome|Pancrelipase|Pancrelipase delayed release 12000 units treatment
1051517|NCT00690820|O1|Outcome|Placebo|Placebo treatment
1051518|NCT00690820|O2|Outcome|Pancrelipase|Pancrelipase delayed release 12000 units treatment
1051519|NCT00690820|O1|Outcome|Placebo|Placebo treatment
1051520|NCT00690820|O2|Outcome|Pancrelipase|Pancrelipase delayed release 12000 units treatment
1051521|NCT00690820|O1|Outcome|Placebo|Placebo treatment
1051522|NCT00690820|O2|Outcome|Pancrelipase|Pancrelipase delayed release 12000 units treatment
1051523|NCT00690820|O1|Outcome|Placebo|Placebo treatment
1051524|NCT00690820|O2|Outcome|Pancrelipase|Pancrelipase delayed release 12000 units treatment
1051525|NCT00690820|O1|Outcome|Placebo|Placebo treatment
1051526|NCT00690820|O2|Outcome|Pancrelipase|Pancrelipase delayed release 12000 units treatment
1051527|NCT00690820|O1|Outcome|Placebo|Placebo treatment
1051528|NCT00690820|E2|Reported Event|Pancrelipase|Pancrelipase delayed release 12000 units treatment
1051529|NCT00690820|E1|Reported Event|Placebo|Placebo treatment
1051530|NCT00690794|B3|Baseline|Total|Total of all reporting groups
1051531|NCT00690794|B2|Baseline|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
1051532|NCT00690794|B1|Baseline|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
1051533|NCT00690794|P2|Participant Flow|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
1051534|NCT00690794|P1|Participant Flow|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
1051535|NCT00690794|O2|Outcome|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
1051536|NCT00690794|O1|Outcome|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
1051537|NCT00690794|O2|Outcome|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
1051538|NCT00690794|O1|Outcome|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
1051539|NCT00690794|E2|Reported Event|Latanoprost|One drop self-administered in the study eye(s) once daily for 90 days
1051540|NCT00690794|E1|Reported Event|Travoprost|One drop self-administered in the study eye(s) once daily for 90 days
1051541|NCT00690755|B8|Baseline|Total|Total of all reporting groups
1051542|NCT00690755|B7|Baseline|Group 7|Non-Diabetic treated with Metformin
1051543|NCT00690755|B6|Baseline|Group 6|Impaired glucose tolerance (IGT)
1051544|NCT00690755|B5|Baseline|Group 5|Non-Diabetic and Type 2 Diabetic subjected to exercise study
1051545|NCT00690755|B4|Baseline|Group 4|Non-Diabetic Overweight
1051546|NCT00690755|B3|Baseline|Group 3|Control (non-diabetic)
1051547|NCT00690755|B2|Baseline|Group 2|Type 1 Diabetic
1051548|NCT00690755|B1|Baseline|Group 1|Type 2 diabetic
1051549|NCT00690755|P7|Participant Flow|Group 7|Non-diabetic treated with Metformin
1051550|NCT00690755|P6|Participant Flow|Group 6|Impaired glucose tolerance (IGT)
1051551|NCT00690755|P5|Participant Flow|Group 5|Non-diabetic and Type 2 diabetic
1051552|NCT00690755|P4|Participant Flow|Group 4|Non-diabetic overweight
1051553|NCT00690755|P3|Participant Flow|Group 3|Control (non-diabetic)
1051554|NCT00690755|P2|Participant Flow|Group 2|Type 1 diabetic
1051555|NCT00690755|P1|Participant Flow|Group 1|Type 2 diabetic
1051556|NCT00690755|O7|Outcome|Group 7|Non-diabetic treated with Metformin
1051557|NCT00690755|O6|Outcome|Group 6|Impaired glucose tolerance (IGT)
1051558|NCT00690755|O5|Outcome|Group 5|Non-diabetic and Type 2 diabetic
1051559|NCT00690755|O4|Outcome|Group 4|Non-diabetic overweight
1051560|NCT00690755|O3|Outcome|Group 3|Control (non-diabetic)
1051561|NCT00690755|O2|Outcome|Group 2|Type 1 diabetic
1051562|NCT00690755|O1|Outcome|Group 1|Type 2 diabetic
1051563|NCT00690755|E7|Reported Event|Group 7|Non-diabetic treated with Metformin
1051564|NCT00690755|E6|Reported Event|Group 6|Impaired glucose tolerance (IGT)
1051565|NCT00690755|E5|Reported Event|Group 5|Non-diabetic and Type 2 diabetic
1051566|NCT00690755|E4|Reported Event|Group 4|Non-diabetic overweight
1051567|NCT00690755|E3|Reported Event|Group 3|Control (non-diabetic)
1051568|NCT00690755|E2|Reported Event|Group 2|Type 1 diabetes
1051569|NCT00690755|E1|Reported Event|Group 1|Diabetics
1057124|NCT00675792|O2|Outcome|Neostigmine|50 µg/kg neostigmine
1051570|NCT00690612|B1|Baseline|Atacand Candesartan Cilexetil|candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.
1051571|NCT00690612|P1|Participant Flow|Atacand Candesartan Cilexetil|candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.
1051572|NCT00690612|O1|Outcome|Atacand Candesartan Cilexetil|candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.
1051573|NCT00690612|O1|Outcome|Atacand Candesartan Cilexetil|candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.
1051574|NCT00690612|E1|Reported Event|Atacand Candesartan Cilexetil|candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.
1051575|NCT00690573|B1|Baseline|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
1051576|NCT00690573|P1|Participant Flow|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
1051577|NCT00690573|O1|Outcome|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
1051578|NCT00690573|O1|Outcome|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
1051579|NCT00690573|O1|Outcome|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
1051580|NCT00690573|O1|Outcome|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
1051581|NCT00690573|O1|Outcome|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
1051582|NCT00690573|E1|Reported Event|Adalimumab|Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
1051583|NCT00690495|B3|Baseline|Total|Total of all reporting groups
1051584|NCT00690495|B2|Baseline|Propofol 1%|Propofol 1%
1051585|NCT00690495|B1|Baseline|Modified Propofol|Modified propofol (Propofol 0.5%)
1051586|NCT00690495|P2|Participant Flow|Propofol 1%|Propofol 1%
1051587|NCT00690495|P1|Participant Flow|Modified Propofol|Modified propofol (Propofol 0.5%)
1051588|NCT00690495|O2|Outcome|Propofol 1%|Propofol 1%
1051589|NCT00690495|O1|Outcome|Modified Propofol|Modified propofol (Propofol 0.5%)
1051590|NCT00690495|E2|Reported Event|Propofol 1%|Propofol 1%
1051591|NCT00690495|E1|Reported Event|Modified Propofol|Modified propofol (Propofol 0.5%)
1051592|NCT00690482|B3|Baseline|Total|Total of all reporting groups
1051593|NCT00690482|B2|Baseline|Placebo|Placebo Oral tablet, twice daily
1051594|NCT00690482|B1|Baseline|AZD1981|AZD1981 Oral tablet, twice daily
1051595|NCT00690482|P2|Participant Flow|Placebo|Placebo Oral tablet, twice daily
1051596|NCT00690482|P1|Participant Flow|AZD1981|AZD1981 Oral tablet, twice daily
1051597|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
1051598|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
1051599|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
1051600|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
1051601|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
1051602|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
1051603|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
1051604|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
1051605|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
1051606|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
1051607|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
1051608|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
1051609|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
1051610|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
1051611|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
1051612|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
1051613|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
1051614|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
1051615|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
1051616|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
1051617|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
1051618|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
1051619|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
1051620|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
1051621|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
1051622|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
1051623|NCT00690482|O2|Outcome|Placebo|Placebo Oral tablet, twice daily
1051624|NCT00690482|O1|Outcome|AZD1981|AZD1981 Oral tablet, twice daily
1051625|NCT00690482|E2|Reported Event|Placebo|Placebo Oral tablet, twice daily
1051626|NCT00690482|E1|Reported Event|AZD1981|AZD1981 Oral tablet, twice daily
1051627|NCT00690443|B3|Baseline|Total|Total of all reporting groups
1051628|NCT00690443|B2|Baseline|Atorvastatin 20 mg + Lomitapide|Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
1051629|NCT00690443|B1|Baseline|Atorvastatin 20 mg|Oral atorvastatin 20 mg for 8 weeks
1051630|NCT00690443|P2|Participant Flow|Atorvastatin 20 mg + Lomitapide|Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
1051631|NCT00690443|P1|Participant Flow|Atorvastatin 20 mg|Oral atorvastatin 20 mg for 8 weeks
1051632|NCT00690443|O2|Outcome|Atorvastatin 20 mg + Lomitapide|Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
1051633|NCT00690443|O1|Outcome|Atorvastatin 20 mg|Oral atorvastatin 20 mg for 8 weeks
1051634|NCT00690443|O2|Outcome|Atorvastatin 20 mg + Lomitapide|Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
1051635|NCT00690443|O1|Outcome|Atorvastatin 20 mg|Oral atorvastatin 20 mg for 8 weeks
1051636|NCT00690443|E2|Reported Event|Atorvastatin 20 mg + Lomitapide|Oral atorvastatin 20 mg and lomitapide 2.5 mg for 4 weeks, followed by 4 weeks of atorvastatin 20 mg and lomitapide 5 mg
1051637|NCT00690443|E1|Reported Event|Atorvastatin 20 mg|Oral atorvastatin 20 mg for 8 weeks
1051638|NCT00690430|B3|Baseline|Total|Total of all reporting groups
1051639|NCT00690430|B2|Baseline|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
1051640|NCT00690430|B1|Baseline|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
1051641|NCT00690430|P3|Participant Flow|Extension: Octreotide LAR/Pasireotide LAR|After 6 month double blind core period, non-responders on Octreotide were given option to cross over to Pasireotide LAR in the Extension Phase of study.
1051642|NCT00690430|P2|Participant Flow|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
1051643|NCT00690430|P1|Participant Flow|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
1051644|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
1051645|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
1051646|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
1051647|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
1051648|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
1051649|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
1051650|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
1051709|NCT00689871|P4|Participant Flow|Revision-reconstruction|All women implanted for revision of a breast reconstruction
1051710|NCT00689871|P3|Participant Flow|Revision-augmentation|All women implanted for revision of a breast augmentation
1051651|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
1051652|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
1051653|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
1051654|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
1051655|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
1051656|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
1051657|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
1051658|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
1051659|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
1051660|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
1051661|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
1051662|NCT00690430|O2|Outcome|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
1051663|NCT00690430|O1|Outcome|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
1051664|NCT00690430|E5|Reported Event|Crossover to Pasireotide LAR|After 6 month double blind core period, non-responders on Octreotide were given option to cross over to Pasireotide LAR in the Extension Phase of study.
1051665|NCT00690430|E4|Reported Event|Extension Phase Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
1051711|NCT00689871|P2|Participant Flow|Primary Reconstruction|All women implanted for an indication of primary breast reconstruction
1051666|NCT00690430|E3|Reported Event|Extension Phase Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
1051667|NCT00690430|E2|Reported Event|Octreotide LAR|Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy. In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
1051668|NCT00690430|E1|Reported Event|Pasireotide LAR|Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed.
1051669|NCT00690339|B5|Baseline|Total|Total of all reporting groups
1051670|NCT00690339|B4|Baseline|Revision-reconstruction|"Revision-reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
1051671|NCT00690339|B3|Baseline|Revision-augmentation|"Revision-augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
1051672|NCT00690339|B2|Baseline|Reconstruction|"Reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
1051673|NCT00690339|B1|Baseline|Augmentation|"Augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
1051674|NCT00690339|P4|Participant Flow|Revision-reconstruction|"Revision-reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
1051675|NCT00690339|P3|Participant Flow|Revision-augmentation|"Revision-augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
1051676|NCT00690339|P2|Participant Flow|Reconstruction|"Reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
1051677|NCT00690339|P1|Participant Flow|Augmentation|"Augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
1051678|NCT00690339|O4|Outcome|Revision-reconstruction|"Revision-reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
1051679|NCT00690339|O3|Outcome|Revision-augmentation|"Revision-augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
1051680|NCT00690339|O2|Outcome|Reconstruction|"Reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
1051681|NCT00690339|O1|Outcome|Augmentation|"Augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
1051682|NCT00690339|O4|Outcome|Revision-reconstruction|"Revision-reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
1051683|NCT00690339|O3|Outcome|Revision-augmentation|"Revision-augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
1051684|NCT00690339|O2|Outcome|Reconstruction|"Reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
1051685|NCT00690339|O1|Outcome|Augmentation|"Augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
1051686|NCT00690339|E4|Reported Event|Revision-reconstruction|"Revision-reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
1051687|NCT00690339|E3|Reported Event|Revision-augmentation|"Revision-augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
1051688|NCT00690339|E2|Reported Event|Reconstruction|"Reconstruction~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
1051689|NCT00690339|E1|Reported Event|Augmentation|"Augmentation~Style 410 Silicone-Filled Breast Implants: Breast Implant Surgery"
1051690|NCT00690040|B3|Baseline|Total|Total of all reporting groups
1051691|NCT00690040|B2|Baseline|Double Balloon Catheter|Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter)
1051692|NCT00690040|B1|Baseline|Single Balloon Catheter|Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter)
1051693|NCT00690040|P2|Participant Flow|Double Balloon Catheter|Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter)
1051694|NCT00690040|P1|Participant Flow|Single Balloon Catheter|Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter)
1051695|NCT00690040|O2|Outcome|Double Balloon Catheter|Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter)
1051696|NCT00690040|O1|Outcome|Single Balloon Catheter|Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter)
1051697|NCT00690040|E2|Reported Event|Double Balloon Catheter|Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter)
1051698|NCT00690040|E1|Reported Event|Single Balloon Catheter|Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter)
1051699|NCT00689884|B1|Baseline|Chemotherapy Plus Pegfilgrastim|All eligible patients will receive chemotherapy and one dose of Pegfilgrastim
1051700|NCT00689884|P1|Participant Flow|Chemotherapy Plus Pegfilgrastim|All eligible patients will receive chemotherapy and one dose of Pegfilgrastim
1051701|NCT00689884|O1|Outcome|Group 1|Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed.
1051702|NCT00689884|O1|Outcome|Chemotherapy Plus Pegfilgrastim|Outcome was not reported. The study was terminated for lack of enrollment. Data collection was terminated. No data analysis was performed.
1051703|NCT00689884|E1|Reported Event|Chemotherapy Plus Pegfilgrastim|All eligible patients will receive chemotherapy and one dose of Pegfilgrastim
1051704|NCT00689871|B5|Baseline|Total|Total of all reporting groups
1051705|NCT00689871|B4|Baseline|Revision-reconstruction|All women implanted for revision of a breast reconstruction
1051706|NCT00689871|B3|Baseline|Revision-augmentation|All women implanted for revision of a breast augmentation
1051707|NCT00689871|B2|Baseline|Primary Reconstruction|All women implanted for an indication of primary breast reconstruction
1051708|NCT00689871|B1|Baseline|Primary Augmentation|All women implanted for an indication of primary breast augmentation
1051713|NCT00689871|O4|Outcome|Revision-reconstruction|All women implanted for revision of a breast reconstruction
1051714|NCT00689871|O3|Outcome|Revision-augmentation|All women implanted for revision of a breast augmentation
1051715|NCT00689871|O2|Outcome|Primary Reconstruction|All women implanted for an indication of primary breast reconstruction
1051716|NCT00689871|O1|Outcome|Primary Augmentation|All women implanted for an indication of primary breast augmentation
1051717|NCT00689871|O4|Outcome|Revision-reconstruction|All women implanted for revision of a breast reconstruction
1051718|NCT00689871|O3|Outcome|Revision-augmentation|All women implanted for revision of a breast augmentation
1051719|NCT00689871|O2|Outcome|Primary Reconstruction|All women implanted for an indication of primary breast reconstruction
1051720|NCT00689871|O1|Outcome|Primary Augmentation|All women implanted for an indication of primary breast augmentation
1051721|NCT00689871|E4|Reported Event|Revision-reconstruction|All women implanted for revision of a breast reconstruction
1051722|NCT00689871|E3|Reported Event|Revision-augmentation|All women implanted for revision of a breast augmentation
1051723|NCT00689871|E2|Reported Event|Primary Reconstruction|All women implanted for an indication of primary breast reconstruction
1051724|NCT00689871|E1|Reported Event|Primary Augmentation|All women implanted for an indication of primary breast augmentation
1051725|NCT00689819|B3|Baseline|Total|Total of all reporting groups
1051726|NCT00689819|B2|Baseline|Treatment 2|This arm will target a more aggressive blood pressure target of < 120/80 mmHg.
1051727|NCT00689819|B1|Baseline|Treatment 1|This arm will target a blood pressure of < 140/90 mmHg (or < 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.
1051728|NCT00689819|P2|Participant Flow|Treatment 2|This arm will target a more aggressive blood pressure target of < 120/80 mmHg.
1051729|NCT00689819|P1|Participant Flow|Treatment 1|This arm will target a blood pressure of < 140/90 mmHg (or < 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.
1051730|NCT00689819|O2|Outcome|Treatment 2|This arm will target a more aggressive blood pressure target of < 120/80 mmHg.
1051731|NCT00689819|O1|Outcome|Treatment 1|This arm will target a blood pressure of < 140/90 mmHg (or < 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.
1051732|NCT00689819|O2|Outcome|Treatment 2|This arm will target a more aggressive blood pressure target of < 120/80 mmHg.
1051733|NCT00689819|O1|Outcome|Treatment 1|This arm will target a blood pressure of < 140/90 mmHg (or < 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.
1051734|NCT00689819|E2|Reported Event|Treatment 2|This arm will target a more aggressive blood pressure target of < 120/80 mmHg.
1051735|NCT00689819|E1|Reported Event|Treatment 1|This arm will target a blood pressure of < 140/90 mmHg (or < 130/90 mmHg for diabetics or those with chronic kidney disease) as indicated by the 7th Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.
1051736|NCT00689793|B3|Baseline|Total|Total of all reporting groups
1051737|NCT00689793|B2|Baseline|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
1051738|NCT00689793|B1|Baseline|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
1051739|NCT00689793|P2|Participant Flow|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
1051740|NCT00689793|P1|Participant Flow|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
1051741|NCT00689793|O2|Outcome|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
1051742|NCT00689793|O1|Outcome|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
1051743|NCT00689793|O2|Outcome|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
1051744|NCT00689793|O1|Outcome|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
1051745|NCT00689793|O2|Outcome|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
1051746|NCT00689793|O1|Outcome|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
1051747|NCT00689793|O2|Outcome|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
1051748|NCT00689793|O1|Outcome|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
1051749|NCT00689793|O2|Outcome|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
1051750|NCT00689793|O1|Outcome|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily), during one month.
1051751|NCT00689793|O2|Outcome|Placebo|One week after donation, donors self-administered one pill of placebo (daily), during 4 weeks.
1051752|NCT00689793|O1|Outcome|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
1051753|NCT00689793|E2|Reported Event|Placebo|One week after donation, donors self-administered on pill of placebo (daily), during one month.
1051754|NCT00689793|E1|Reported Event|Oral Treatment of Iron|One week after donation, donors self-administered ferrous sulfate (80mg of elemental iron daily) during one month.
1051755|NCT00689611|B3|Baseline|Total|Total of all reporting groups
1051756|NCT00689611|B2|Baseline|Bupropion|"participants received bupropion for 9 weeks.~Bupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks"
1051757|NCT00689611|B1|Baseline|Placebo|"participants received placebo for 9 weeks.~Placebo: Placebo"
1051758|NCT00689611|P2|Participant Flow|Bupropion|"Participants received bupropion for 9 weeks.~Bupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks."
1051759|NCT00689611|P1|Participant Flow|Placebo|Participants received placebo for 9 weeks.
1051760|NCT00689611|O2|Outcome|Bupropion|"Participants received bupropion for 9 weeks.~Bupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks"
1051761|NCT00689611|O1|Outcome|Placebo|Participants received placebo for 9 weeks.
1051762|NCT00689611|O2|Outcome|Bupropion|"Participants received bupropion for 9 weeks.~Bupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks"
1051763|NCT00689611|O1|Outcome|Placebo|Participants received placebo for 9 weeks.
1051764|NCT00689611|E2|Reported Event|Bupropion|"Participants received bupropion for 9 weeks.~Bupropion HCl ER: 150 mg tablets po qd for 3 days and then 150 mg po bid for remainder of 9 weeks"
1051765|NCT00689611|E1|Reported Event|Placebo|Participants received placebo for 9 weeks.
1051766|NCT00689481|B3|Baseline|Total|Total of all reporting groups
1051767|NCT00689481|B2|Baseline|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1051768|NCT00689481|B1|Baseline|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1051769|NCT00689481|P2|Participant Flow|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1051770|NCT00689481|P1|Participant Flow|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1051771|NCT00689481|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1051772|NCT00689481|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1051773|NCT00689481|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1051774|NCT00689481|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1051775|NCT00689481|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1051776|NCT00689481|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1051777|NCT00689481|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1051778|NCT00689481|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1051779|NCT00689481|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1051780|NCT00689481|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1051781|NCT00689481|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1051782|NCT00689481|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1051783|NCT00689481|E2|Reported Event|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1051784|NCT00689481|E1|Reported Event|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1051785|NCT00689390|B3|Baseline|Total|Total of all reporting groups
1051786|NCT00689390|B2|Baseline|Participants From Narlaprevir Studies|Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.
1051787|NCT00689390|B1|Baseline|Participants From Boceprevir Studies|Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.
1051788|NCT00689390|P2|Participant Flow|Participants From Narlaprevir Studies|Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.
1051789|NCT00689390|P1|Participant Flow|Participants From Boceprevir Studies|Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.
1051816|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1057125|NCT00675792|O1|Outcome|Sugammadex|4 mg/kg sugammadex
1054440|NCT00683618|E3|Reported Event|Atorvastatin 10mg|Taken orally once daily
1051790|NCT00689390|O2|Outcome|Participants From Narlaprevir Studies|Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.
1051791|NCT00689390|O1|Outcome|Participants From Boceprevir Studies|Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.
1051792|NCT00689390|O2|Outcome|Participants From Narlaprevir Studies|Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.
1051793|NCT00689390|O1|Outcome|Participants From Boceprevir Studies|Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.
1051794|NCT00689390|O2|Outcome|Participants From Narlaprevir Studies With TE-RAVs|Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.
1051795|NCT00689390|O1|Outcome|Participants From Boceprevir Studies With TE-RAVs|Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.
1051796|NCT00689390|O3|Outcome|Previous SVR on PR Only|Participants who previously received PR only in boceprevir or narlaprevir treatment studies and achieved SVR. No treatment was administered in the current follow-up study
1051797|NCT00689390|O2|Outcome|Previous SVR on Narlaprevir + PR|Participants who previously received narlaprevir plus PR in treatment studies and achieved SVR. No treatment was administered in the current follow-up study.
1051798|NCT00689390|O1|Outcome|Previous SVR on Boceprevir + PR|Participants who previously received boceprevir plus PR in treatment studies and achieved sustained virologic response (SVR). No treatment was administered in the current follow-up study.
1051799|NCT00689390|O3|Outcome|Previous SVR on PR Only|Participants who previously received PR only in boceprevir or narlaprevir treatment studies and achieved SVR. No treatment was administered in the current follow-up study
1051800|NCT00689390|O2|Outcome|Previous SVR on Narlaprevir + PR|Participants who previously received narlaprevir plus PR in treatment studies and achieved SVR. No treatment was administered in the current follow-up study.
1051801|NCT00689390|O1|Outcome|Previous SVR on Boceprevir + PR|Participants who previously received boceprevir plus PR in treatment studies and achieved sustained virologic response (SVR). No treatment was administered in the current follow-up study.
1051802|NCT00689390|E2|Reported Event|Participants From Narlaprevir Studies|Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.
1051803|NCT00689390|E1|Reported Event|Participants From Boceprevir Studies|Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.
1051804|NCT00689351|B3|Baseline|Total|Total of all reporting groups
1051805|NCT00689351|B2|Baseline|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1051806|NCT00689351|B1|Baseline|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1051807|NCT00689351|P2|Participant Flow|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1051808|NCT00689351|P1|Participant Flow|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1051809|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1051810|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1051811|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1051812|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1051813|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1051814|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1051815|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1057126|NCT00675792|O2|Outcome|Neostigmine|50 µg/kg neostigmine
1051817|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1051818|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1051819|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1051820|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1051821|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1051822|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1051823|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1051824|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1051825|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1051826|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1051827|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1051828|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1051829|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1051830|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1051831|NCT00689351|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1051832|NCT00689351|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1051833|NCT00689351|E6|Reported Event|Toddler Dose 7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC ) 0.5mL dose administered IM at 12 months of age (toddler dose).
1051834|NCT00689351|E5|Reported Event|Toddler Dose 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5mL dose administered IM at 12 months of age (toddler dose).
1051835|NCT00689351|E4|Reported Event|After the Infant Series 7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age).
1051836|NCT00689351|E3|Reported Event|After the Infant Series 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age).
1051837|NCT00689351|E2|Reported Event|Infant Series 7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series).
1051838|NCT00689351|E1|Reported Event|Infant Series 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series).
1051839|NCT00689338|B1|Baseline|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
1051840|NCT00689338|P1|Participant Flow|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
1051841|NCT00689338|O1|Outcome|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
1051842|NCT00689338|O1|Outcome|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
1051843|NCT00689338|O1|Outcome|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
1051844|NCT00689338|O1|Outcome|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
1051845|NCT00689338|O1|Outcome|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
1051911|NCT00689117|B3|Baseline|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
1051846|NCT00689338|O1|Outcome|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
1051847|NCT00689338|O1|Outcome|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
1051848|NCT00689338|E1|Reported Event|Anidulafungin|Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.
1051849|NCT00689299|B4|Baseline|Total|Total of all reporting groups
1051850|NCT00689299|B3|Baseline|2.1 Units Fel d 1 Standardized Allergenic Extract, Cat Hair (F|Active Dose Group B
1051851|NCT00689299|B2|Baseline|0.21 Units Fel d 1 Standardized Allergenic Extract, Cat Hair (|Active Dose Group A
1051852|NCT00689299|B1|Baseline|Placebo|Placebo - Dose Group C
1051853|NCT00689299|P3|Participant Flow|0.21 Units Fel d 1|"Active Dose Group A~From a concentration of 14.0 Units/mL of Fel d 1 diluted 1:10 v/v, a maintenance dose of 0.15 mL (0.21 Units Fel d 1) was administered as a daily oral liquid via sublingual route."
1051854|NCT00689299|P2|Participant Flow|2.1 Units Fel d 1|"Active Dose Group B~From a concentration of 14.0 Units/mL of Fel d 1, a maintenance dose of 0.15 mL (2.1 Units Fel d 1) was administered as a daily oral liquid via sublingual route."
1051855|NCT00689299|P1|Participant Flow|Placebo|Maintenance dose of 0.15 mL of liquid placebo administered as a daily oral liquid via sublingual route.
1051856|NCT00689299|O3|Outcome|2.1 Units Standardized Allergenic Extract, Cat Hair|Dose Group B
1051857|NCT00689299|O2|Outcome|0.21 Units Standardized Allergenic Extract, Cat Hair|Dose Group A
1051858|NCT00689299|O1|Outcome|Placebo|Dose Group C: placebo Standardized Allergenic Extract, Cat Hair (Felis domesticus)
1051859|NCT00689299|E3|Reported Event|Dose Group B|2.1 Units Standardized Allergenic Extract, Cat Hair (Felis domesticus)
1051860|NCT00689299|E2|Reported Event|Dose Group A|0.21 Units Standardized Allergenic Extract, Cat Hair (Felis domesticus)
1051861|NCT00689299|E1|Reported Event|Dose Group C|placebo Standardized Allergenic Extract, Cat Hair (Felis domesticus)
1051862|NCT00689260|B3|Baseline|Total|Total of all reporting groups
1051863|NCT00689260|B2|Baseline|Log Unaware|Dose Log UnaAware and Daily Diary Disabled
1051864|NCT00689260|B1|Baseline|Log Aware|Dose Log Aware and Daily Diary Enabled
1051865|NCT00689260|P2|Participant Flow|Log Unaware|Dose Log UnaAware and Daily Diary Disabled
1051866|NCT00689260|P1|Participant Flow|Log Aware|Dose Log Aware and Daily Diary Enabled
1051867|NCT00689260|O3|Outcome|Total|
1051868|NCT00689260|O2|Outcome|Genotropin|Subjects previously using the Pfizer Genotropin
1051869|NCT00689260|O1|Outcome|Humatrope|Subjects previously using the Lilly Humatrope
1051870|NCT00689260|O3|Outcome|Total|
1051871|NCT00689260|O2|Outcome|Genotropin|Subjects previously using the Pfizer Genotropin
1051872|NCT00689260|O1|Outcome|Humatrope|Subjects previously using the Lilly Humatrope
1051873|NCT00689260|O3|Outcome|Total|
1051874|NCT00689260|O2|Outcome|Genotropin|Subjects previously using the Pfizer Genotropin
1051875|NCT00689260|O1|Outcome|Humatrope|Subjects previously using the Lilly Humatrope
1051876|NCT00689260|O3|Outcome|Total|
1051877|NCT00689260|O2|Outcome|Log Unaware|Dose Log UnaAware and Daily Diary Disabled
1051878|NCT00689260|O1|Outcome|Log Aware|Dose Log Aware and Daily Diary Enabled
1051879|NCT00689260|E2|Reported Event|Log Unaware|Dose Log UnaAware and Daily Diary Disabled
1051880|NCT00689260|E1|Reported Event|Log Aware|Dose Log Aware and Daily Diary Enabled
1051881|NCT00689221|B3|Baseline|Total|Total of all reporting groups
1051882|NCT00689221|B2|Baseline|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
1051883|NCT00689221|B1|Baseline|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1051884|NCT00689221|P2|Participant Flow|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
1051885|NCT00689221|P1|Participant Flow|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1051912|NCT00689117|B2|Baseline|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
1051886|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
1051887|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1051888|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
1051889|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1051890|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
1051891|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1051892|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
1051893|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1051894|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
1051895|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1051896|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
1051897|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1051950|NCT00689104|P1|Participant Flow|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1051898|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
1051899|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1051900|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1051901|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1051902|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1051903|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
1051904|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1051905|NCT00689221|O2|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
1051906|NCT00689221|O1|Outcome|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1051907|NCT00689221|E2|Reported Event|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
1051908|NCT00689221|E1|Reported Event|Cilengitide + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 will be optional in participants without disease progression, If cilengitide treatment considered beneficial in the opinion of the Investigator,
1051909|NCT00689117|B5|Baseline|Total|Total of all reporting groups
1051910|NCT00689117|B4|Baseline|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
1051913|NCT00689117|B1|Baseline|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
1051914|NCT00689117|P4|Participant Flow|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
1051915|NCT00689117|P3|Participant Flow|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
1051916|NCT00689117|P2|Participant Flow|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
1051917|NCT00689117|P1|Participant Flow|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
1051918|NCT00689117|O4|Outcome|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
1051919|NCT00689117|O3|Outcome|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
1051920|NCT00689117|O2|Outcome|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
1051921|NCT00689117|O1|Outcome|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
1051922|NCT00689117|O4|Outcome|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
1051923|NCT00689117|O3|Outcome|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
1051924|NCT00689117|O2|Outcome|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
1051925|NCT00689117|O1|Outcome|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
1051926|NCT00689117|O4|Outcome|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
1051927|NCT00689117|O3|Outcome|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
1051928|NCT00689117|O2|Outcome|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
1051929|NCT00689117|O1|Outcome|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
1051930|NCT00689117|O4|Outcome|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
1051931|NCT00689117|O3|Outcome|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
1051932|NCT00689117|O2|Outcome|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
1051933|NCT00689117|O1|Outcome|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
1051934|NCT00689117|O4|Outcome|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
1051935|NCT00689117|O3|Outcome|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
1051936|NCT00689117|O2|Outcome|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
1051937|NCT00689117|O1|Outcome|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
1051938|NCT00689117|E4|Reported Event|Vehicle Gel|Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
1051939|NCT00689117|E3|Reported Event|Tretinoin Gel|Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
1051940|NCT00689117|E2|Reported Event|Clindamycin Gel|Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
1051941|NCT00689117|E1|Reported Event|CT Gel|Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
1051942|NCT00689104|B5|Baseline|Total|Total of all reporting groups
1051943|NCT00689104|B4|Baseline|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1051944|NCT00689104|B3|Baseline|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1051945|NCT00689104|B2|Baseline|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1051946|NCT00689104|B1|Baseline|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1051947|NCT00689104|P4|Participant Flow|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1051948|NCT00689104|P3|Participant Flow|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1051949|NCT00689104|P2|Participant Flow|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052029|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1051951|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1051952|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1051953|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1051954|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1051955|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1051956|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1051957|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1051958|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1051959|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1051960|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1051961|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1051962|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1051963|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1051964|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1051965|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1051966|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1051967|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1051968|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1051969|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1051970|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1051971|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1051972|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1051973|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1051974|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1051975|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1051976|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1051977|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1051978|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1051979|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1051980|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1051981|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1051982|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1051983|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1051984|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1051985|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1051986|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1051987|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1051988|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1051989|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052113|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
1051990|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1051991|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1051992|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1051993|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1051994|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1051995|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1051996|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1051997|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1051998|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1051999|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1052000|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052001|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052002|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1052003|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1052004|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052005|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052006|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1052007|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1052008|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052009|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052010|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1052011|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1052012|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052013|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052014|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1052015|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1052016|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052017|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052018|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1052019|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1052020|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052021|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052022|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1052023|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1052024|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052025|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052026|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1052027|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1052028|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1057127|NCT00675792|O1|Outcome|Sugammadex|4 mg/kg sugammadex
1052030|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1052031|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1052032|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052033|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052034|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1052035|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1052036|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052037|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052038|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1052039|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1052040|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052041|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052042|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1052043|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1052044|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052045|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052046|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1052047|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1052048|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052049|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052050|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1052051|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1052052|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052053|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052054|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1052055|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1052056|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052057|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052058|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1052059|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1052060|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052061|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052062|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1052063|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1052064|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052065|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052066|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1052067|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1052068|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1057128|NCT00675792|E2|Reported Event|Neostigmine|50 µg/kg neostigmine
1052069|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052070|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1052071|NCT00689104|O4|Outcome|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1052072|NCT00689104|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052073|NCT00689104|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052074|NCT00689104|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1052075|NCT00689104|E4|Reported Event|Tolterodine SR 4 mg|Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks.
1052076|NCT00689104|E3|Reported Event|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052077|NCT00689104|E2|Reported Event|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks.
1052078|NCT00689104|E1|Reported Event|Placebo|Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks.
1052079|NCT00689091|B3|Baseline|Total|Total of all reporting groups
1052080|NCT00689091|B2|Baseline|Minimum Anesthesia Concentration Alert|"This group will receive an alert if total MAC (including intravenous infusions) is <0.5 age-adjusted.~Electronic MAC alert: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
1052081|NCT00689091|B1|Baseline|Bispectral Index Group|"This group will have BIS values visible and will receive alerts when the value is >60.~Bispectral Index Monitor: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
1052082|NCT00689091|P2|Participant Flow|Minimum Anesthesia Contration Alert|"This group will receive an alert if total MAC (Minimum Anesthesia Concenration) (including intravenous infusions) is <0.5 age-adjusted.~Electronic MAC alert: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
1052083|NCT00689091|P1|Participant Flow|Bispectral Index Group|"This group will have BIS values visible and will receive alerts when the value is >60.~Bispectral Index Monitor: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
1052084|NCT00689091|O2|Outcome|MAC Alert|"This group will receive an alert if total MAC (including intravenous infusions) is <0.5 age-adjusted.~Electronic MAC alert: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
1052085|NCT00689091|O1|Outcome|BIS Group|"This group will have BIS values visible and will receive alerts when the value is >60.~Bispectral Index Monitor: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
1052086|NCT00689091|E2|Reported Event|Miniumum Anesthesia Concentration Alert|"This group will receive an alert if total MAC (including intravenous infusions) is <0.5 age-adjusted.~Electronic MAC alert: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
1052087|NCT00689091|E1|Reported Event|Bispectral Index Group|"This group will have BIS values visible and will receive alerts when the value is >60.~Bispectral Index Monitor: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols."
1052088|NCT00689052|B3|Baseline|Total|Total of all reporting groups
1052089|NCT00689052|B2|Baseline|Pramipexole|Patients receiving pramipexole
1052090|NCT00689052|B1|Baseline|Placebo|Patients receiving matching placebo
1052091|NCT00689052|P2|Participant Flow|Pramipexole|Patients receive pramipexole in dose up-titration steps
1052092|NCT00689052|P1|Participant Flow|Placebo|Patients receive placebo in dose up-titration steps
1052093|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
1052094|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
1052095|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
1052096|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
1052097|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
1052098|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
1052099|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
1052100|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
1052101|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
1052102|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
1052103|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
1052104|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
1052105|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
1052106|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
1052107|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
1052108|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
1052109|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
1052110|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
1052111|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
1052112|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
1057129|NCT00675792|E1|Reported Event|Sugammadex|4 mg/kg sugammadex
1052114|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
1052115|NCT00689052|O2|Outcome|Placebo|Placebo tablets, once daily in the evening
1052116|NCT00689052|O1|Outcome|Pramipexole ER|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
1052117|NCT00689052|O2|Outcome|Pramipexole|0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
1052118|NCT00689052|O1|Outcome|Placebo|Placebo tablets, once daily in the evening
1052119|NCT00689052|E2|Reported Event|Pramipexole|
1052120|NCT00689052|E1|Reported Event|Placebo|
1052121|NCT00689026|B3|Baseline|Total|Total of all reporting groups
1052122|NCT00689026|B2|Baseline|Control|PEG colon cleansing
1052123|NCT00689026|B1|Baseline|Experimental|PEG plus lubiprostone colon cleansing
1052124|NCT00689026|P2|Participant Flow|Control|Control group received the standard treatment of polyethylene glycol electrolytes the evening prior to the colonoscopy.
1052125|NCT00689026|P1|Participant Flow|Experimental|Experimental group received one dose of polyethylene glycol electrolyte (PEG) and one does of lubiprostone two hours prior to and two hours after PED completion on the evening prior to the colonoscopy.
1052126|NCT00689026|O2|Outcome|Control|All patients in the control will receive a standard oral 4 Liters PEG colonoscopy preparation the evening prior to their scheduled colonoscopy.
1052127|NCT00689026|O1|Outcome|Experimental|Lubiprostone: Two 24 mcg lubiprostone capsules, which will be taken orally the morning and evening of the day of the 4 Liters PEG prep (before and after the 4 Liters PEG prep).
1052128|NCT00689026|E2|Reported Event|Control|Patients received a standard oral 4 Liters PEG colonoscopy preparation the evening prior to their scheduled colonoscopy
1052129|NCT00689026|E1|Reported Event|Treatment|Patients who were given a two doses of lubiprostone with the PEG colon cleansing solution on the day prior the recorded colonoscopy for cleansing grading
1052130|NCT00688870|B3|Baseline|Total|Total of all reporting groups
1052131|NCT00688870|B2|Baseline|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
1052132|NCT00688870|B1|Baseline|13vPnC|Participants received 1 single 0.5 mL dose of 13vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
1052133|NCT00688870|P2|Participant Flow|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
1052134|NCT00688870|P1|Participant Flow|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
1052135|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
1052136|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
1052137|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
1052138|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
1052165|NCT00688844|B1|Baseline|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
1052166|NCT00688844|P1|Participant Flow|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
1052139|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
1052140|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
1052141|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
1052142|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
1052143|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
1052144|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
1052145|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
1052146|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
1052147|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
1052148|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
1052149|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
1052150|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
1052167|NCT00688844|O1|Outcome|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
1052168|NCT00688844|O1|Outcome|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
1052151|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
1052152|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
1052153|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
1052154|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
1052155|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
1052156|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
1052157|NCT00688870|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
1052158|NCT00688870|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
1052159|NCT00688870|E6|Reported Event|Toddler Dose 7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 15 months of age (toddler dose).
1052160|NCT00688870|E5|Reported Event|Toddler Dose 13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 15 months of age (toddler dose).
1052161|NCT00688870|E4|Reported Event|After the Infant Series 7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
1052162|NCT00688870|E3|Reported Event|After the Infant Series 13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
1052163|NCT00688870|E2|Reported Event|Infant Series 7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
1052164|NCT00688870|E1|Reported Event|Infant Series 13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
1057130|NCT00675766|B5|Baseline|Total|Total of all reporting groups
1052169|NCT00688844|O1|Outcome|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
1052170|NCT00688844|O1|Outcome|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
1052171|NCT00688844|O1|Outcome|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
1052172|NCT00688844|O1|Outcome|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
1052173|NCT00688844|O1|Outcome|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
1052174|NCT00688844|E1|Reported Event|Subjects With Phenylketonuria Starting Sapropterin Therapy|Subjects with Phenylketonuria starting sapropterin therapy for the purpose of lowering blood phenylalanine levels.
1052175|NCT00688753|B1|Baseline|RAD001 10 mg|two 5 mg tablets of everolimus orally, once daily
1052176|NCT00688753|P1|Participant Flow|RAD001|two 5 mg tablets orally, once daily at the same time every day immediately after a meal
1052177|NCT00688753|O1|Outcome|RAD001|10 mg/day
1052178|NCT00688753|O1|Outcome|RAD001|10 mg/day
1052179|NCT00688753|O1|Outcome|RAD001|10 mg/day
1052180|NCT00688753|O1|Outcome|RAD001|10 mg/day
1052181|NCT00688753|O1|Outcome|RAD001|10 mg/day
1052182|NCT00688753|O1|Outcome|RAD001|10 mg/day
1052183|NCT00688753|E1|Reported Event|All Patients|two 5 mg tablets orally, once daily at the same time every day immediately after a meal
1052184|NCT00688740|B3|Baseline|Total|Total of all reporting groups
1052185|NCT00688740|B2|Baseline|FAC (5-fluorouracil)|5-fluorouracil in combination with doxorubicin and cyclophosphamide
1052186|NCT00688740|B1|Baseline|TAC (Docetaxel)|docetaxel in combination with doxorubicin and cyclophosphamide
1052187|NCT00688740|P2|Participant Flow|FAC (5-fluorouracil)|5-fluorouracil in combination with doxorubicin and cyclophosphamide
1052188|NCT00688740|P1|Participant Flow|TAC (Docetaxel)|docetaxel in combination with doxorubicin and cyclophosphamide
1052189|NCT00688740|O2|Outcome|FAC (5-fluorouracil)|5-fluorouracil in combination with doxorubicin and cyclophosphamide
1052190|NCT00688740|O1|Outcome|TAC (Docetaxel)|docetaxel in combination with doxorubicin and cyclophosphamide
1052191|NCT00688740|O2|Outcome|FAC (5-fluorouracil)|5-fluorouracil in combination with doxorubicin and cyclophosphamide
1052192|NCT00688740|O1|Outcome|TAC (Docetaxel)|docetaxel in combination with doxorubicin and cyclophosphamide
1052193|NCT00688740|O2|Outcome|FAC (5-fluorouracil)|5-fluorouracil in combination with doxorubicin and cyclophosphamide
1052194|NCT00688740|O1|Outcome|TAC (Docetaxel)|docetaxel in combination with doxorubicin and cyclophosphamide
1052195|NCT00688740|E2|Reported Event|FAC (5-fluorouracil)|5-fluorouracil in combination with doxorubicin and cyclophosphamide
1052196|NCT00688740|E1|Reported Event|TAC (Docetaxel)|docetaxel in combination with doxorubicin and cyclophosphamide
1052197|NCT00688701|B4|Baseline|Total|Total of all reporting groups
1052198|NCT00688701|B3|Baseline|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to Week 12.
1052199|NCT00688701|B2|Baseline|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 12.
1052200|NCT00688701|B1|Baseline|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
1052201|NCT00688701|P4|Participant Flow|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to Week 12.
1052202|NCT00688701|P3|Participant Flow|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 12.
1052203|NCT00688701|P2|Participant Flow|Placebo (One-Step Titration)|1-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to Week 12.
1052204|NCT00688701|P1|Participant Flow|Placebo (Two-Step Titration)|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 12.
1052205|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
1052206|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
1052207|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
1052208|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
1052209|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
1052210|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
1052211|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
1052212|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
1052213|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
1052214|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
1052215|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
1052216|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
1052217|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
1052218|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
1052219|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
1052220|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
1052221|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
1052222|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
1052223|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
1052224|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
1052225|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
1052226|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
1052227|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
1052228|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
1052229|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
1052230|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
1052231|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
1052232|NCT00688701|O3|Outcome|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
1052233|NCT00688701|O2|Outcome|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
1052234|NCT00688701|O1|Outcome|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
1052235|NCT00688701|E6|Reported Event|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide and 1-step initiation regimen of lixisenatide.
1052236|NCT00688701|E5|Reported Event|Lixisenatide (One-Step Titration)|1-step initiation regimen of lixisenatide.
1052237|NCT00688701|E4|Reported Event|Lixisenatide (Two-Step Titration)|2-step initiation regimen of lixisenatide.
1052238|NCT00688701|E3|Reported Event|Placebo (Combined)|Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
1052239|NCT00688701|E2|Reported Event|Placebo (One-Step Titration)|1-step initiation regimen of volume matching placebo.
1052240|NCT00688701|E1|Reported Event|Placebo (Two-Step Titration)|2-step initiation regimen of volume matching placebo.
1052241|NCT00688688|B4|Baseline|Total|Total of all reporting groups
1052242|NCT00688688|B3|Baseline|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
1052243|NCT00688688|B2|Baseline|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
1052244|NCT00688688|B1|Baseline|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
1052245|NCT00688688|P3|Participant Flow|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
1052246|NCT00688688|P2|Participant Flow|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
1052247|NCT00688688|P1|Participant Flow|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
1052248|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
1052249|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
1052250|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
1052251|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
1052252|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
1052253|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
1052254|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
1052255|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
1052256|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
1052257|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
1052258|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
1052259|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
1052260|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
1052261|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
1052583|NCT00687674|E1|Reported Event|Sorafenib + Lenalidomide + Dexamethasone|
1052262|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
1052263|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
1052264|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
1052265|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
1052266|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
1052267|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
1052268|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
1052269|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
1052270|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
1052271|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
1052272|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
1052273|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
1052274|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
1052275|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
1052276|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
1052277|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
1052278|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
1052279|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
1052280|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
1052281|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
1052282|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
1052283|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
1052284|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
1052285|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
1052286|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
1052287|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
1052288|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
1052289|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
1052290|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
1052291|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
1052292|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
1052293|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
1052294|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
1052295|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
1052296|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
1052297|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
1052298|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
1052299|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
1052300|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
1052301|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
1052302|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
1052303|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
1052304|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
1052305|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
1052306|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
1052307|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
1052308|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
1052309|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
1052310|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
1052311|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
1052312|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
1052313|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
1052314|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
1052315|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
1052316|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
1052317|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
1052318|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
1052319|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
1052320|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
1052321|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
1052322|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
1052323|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
1052324|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
1052325|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
1052326|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
1052327|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
1052328|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
1052329|NCT00688688|O3|Outcome|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
1052330|NCT00688688|O2|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
1052331|NCT00688688|O1|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
1052332|NCT00688688|E3|Reported Event|Tolterodine ER 4 mg|Participants received tolterodine ER 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 months.
1052333|NCT00688688|E2|Reported Event|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets and matching tolterodine ER placebo capsules orally once a day for 12 months.
1052334|NCT00688688|E1|Reported Event|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets and matching tolterodine extended release (ER) placebo capsules orally once a day for 12 months.
1052335|NCT00688662|B3|Baseline|Total|Total of all reporting groups
1052336|NCT00688662|B2|Baseline|2. ERCP Without Sphincterotomy|Endoscopic Retrograde CholangioPancreatography(ERCP) with sphincter manometry and pancreatic stenting, but without sphincterotomy
1052337|NCT00688662|B1|Baseline|1. ERCP With Sphincterotomy|Endoscopic Retrograde CholangioPancreatography (ERCP) with sphincter manometry and biliary and/or pancreatic sphincterotomy and pancreatic stenting
1052338|NCT00688662|P2|Participant Flow|2. ERCP Without Sphincterotomy:|Endoscopic Retrograde CholangioPancreatography (ERCP) without biliary and/or pancreatic sphincterotomy
1052339|NCT00688662|P1|Participant Flow|1.ERCP With Sphincterotomy|Endoscopic Retrograde CholangioPancreatography (ERCP) with biliary and/or pancreatic sphincterotomy
1052340|NCT00688662|O2|Outcome|2.ERCP Without Sphincterotomy|ERCP without sphincterotomy: ERCP with sphincter manometry, but no sphincterotomy
1052341|NCT00688662|O1|Outcome|1.ERCP With Sphincterotomy|ERCP with sphincterotomy: cutting the biliary sphincter muscle (sphincterotomy)
1052342|NCT00688662|O2|Outcome|2. ERCP Without Sphincterotomy|ERCP without sphincterotomy: ERCP with sphincter manometry, but no sphincterotomy
1052343|NCT00688662|O1|Outcome|1.ERCP With Sphincterotomy|ERCP with sphincterotomy: cutting the biliary sphincter muscle (sphincterotomy)
1052344|NCT00688662|E2|Reported Event|2. ERCP Without Sphincterotomy|ERCP without sphincterotomy: ERCP with sphincter manometry, but no sphincterotomy
1052345|NCT00688662|E1|Reported Event|1.ERCP With Sphincterotomy|ERCP with sphincterotomy: cutting the biliary sphincter muscle (sphincterotomy)
1052346|NCT00688636|B3|Baseline|Total|Total of all reporting groups
1052347|NCT00688636|B2|Baseline|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
1052348|NCT00688636|B1|Baseline|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
1052349|NCT00688636|P2|Participant Flow|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
1052350|NCT00688636|P1|Participant Flow|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
1052351|NCT00688636|O2|Outcome|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
1052352|NCT00688636|O1|Outcome|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
1052353|NCT00688636|O2|Outcome|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
1052354|NCT00688636|O1|Outcome|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
1052355|NCT00688636|O2|Outcome|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
1052356|NCT00688636|O1|Outcome|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
1052357|NCT00688636|O2|Outcome|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
1052358|NCT00688636|O1|Outcome|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
1052359|NCT00688636|O2|Outcome|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
1052360|NCT00688636|O1|Outcome|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
1052361|NCT00688636|E2|Reported Event|Placebo|placebo: placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
1052362|NCT00688636|E1|Reported Event|Infliximab|infliximab: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks for 54 weeks
1052363|NCT00688545|B3|Baseline|Total|Total of all reporting groups
1052364|NCT00688545|B2|Baseline|nsNSAIDs|Participants who were prescribed nsNSAIDs at baseline per treating physician's judgment. Any nsNSAID could be used at the discretion of the investigator, provided that the medicine was not contraindicated for the participant as per the current United States product information for that nsNSAID. Participants could switch to other nsNSAIDs or celecoxib at any time during the study. The use and dosage recommendations for study drug took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
1052365|NCT00688545|B1|Baseline|Celecoxib|Participants who were prescribed celecoxib at baseline per treating physician's judgment. Participants could switch to nonselective non-steroidal anti-inflammatory drugs (nsNSAIDs) at any time during the study. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
1052366|NCT00688545|P2|Participant Flow|nsNSAIDs|Participants who were prescribed nsNSAIDs at baseline per treating physician's judgment. Any nsNSAID could be used at the discretion of the investigator, provided that the medicine was not contraindicated for the participant as per the current United States product information for that nsNSAID. Participants could switch to other nsNSAIDs or celecoxib at any time during the study. The use and dosage recommendations for study drug took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
1052367|NCT00688545|P1|Participant Flow|Celecoxib|Participants who were prescribed celecoxib at baseline per treating physician's judgment. Participants could switch to nonselective non-steroidal anti-inflammatory drugs (nsNSAIDs) at any time during the study. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
1052368|NCT00688545|O2|Outcome|nsNSAIDs|Participants who were prescribed nsNSAIDs at baseline per treating physician's judgment. Any nsNSAID could be used at the discretion of the investigator, provided that the medicine was not contraindicated for the participant as per the current United States product information for that nsNSAID. Participants could switch to other nsNSAIDs or celecoxib at any time during the study. The use and dosage recommendations for study drug took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
1052369|NCT00688545|O1|Outcome|Celecoxib|Participants who were prescribed celecoxib at baseline per treating physician's judgment. Participants could switch to nonselective non-steroidal anti-inflammatory drugs (nsNSAIDs) at any time during the study. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity
1052370|NCT00688545|O2|Outcome|nsNSAIDs|Participants who received nsNSAIDs at any time during the study. Treatment assignment per treating physician's judgment. The use and dosage recommendations for nsNSAIDs took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
1052371|NCT00688545|O1|Outcome|Celecoxib|Participants who received celecoxib at any time during the study. Treatment assignment as per treating physician's judgment. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
1052372|NCT00688545|E2|Reported Event|nsNSAIDs|Participants who received nsNSAIDs at any time during the study. Treatment assignment per treating physician's judgment. The use and dosage recommendations for nsNSAIDs took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
1053167|NCT00686894|O1|Outcome|Infliximab 5 mg/kg|Infliximab infusions: 5 mg/kg at weeks 0, 2, and 6.
1052373|NCT00688545|E1|Reported Event|Celecoxib|Participants who were prescribed celecoxib at any time during the study. Treatment assignment per treating physician's judgment. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
1052374|NCT00688519|B3|Baseline|Total|Total of all reporting groups
1052375|NCT00688519|B2|Baseline|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1052376|NCT00688519|B1|Baseline|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1052377|NCT00688519|P2|Participant Flow|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1052378|NCT00688519|P1|Participant Flow|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1052379|NCT00688519|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1052380|NCT00688519|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1052381|NCT00688519|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1052382|NCT00688519|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1052383|NCT00688519|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1052384|NCT00688519|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1052385|NCT00688519|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1052386|NCT00688519|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1052387|NCT00688519|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1052388|NCT00688519|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1052389|NCT00688519|O2|Outcome|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1052390|NCT00688519|O1|Outcome|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1052391|NCT00688519|E2|Reported Event|Vehicle Foam|Vehicle foam is the same as the Calcipotriene Foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1052392|NCT00688519|E1|Reported Event|Calcipotriene Foam|Calcipotriene Foam is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
1052393|NCT00688467|B3|Baseline|Total|Total of all reporting groups
1052394|NCT00688467|B2|Baseline|Placebo → Navarixin|Matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 2
1052395|NCT00688467|B1|Baseline|Navarixin → Placebo|Navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 2
1052396|NCT00688467|P2|Participant Flow|Placebo → Navarixin|Matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 2
1052397|NCT00688467|P1|Participant Flow|Navarixin → Placebo|Navarixin 30 mg capsule to be taken once daily in the morning for 10 days in Treatment Period 1, followed by a 2-4 week washout period, followed by matching placebo capsule to be taken once daily in the morning for 10 days in Treatment Period 2
1052398|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
1052399|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
1052400|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
1052401|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
1052402|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
1052403|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
1052404|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
1052405|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
1052406|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
1052407|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
1052408|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
1052409|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
1052410|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
1052411|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
1052412|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
1052413|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
1052414|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
1052415|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
1052416|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
1052417|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
1052418|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
1052419|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
1052420|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
1052421|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
1052422|NCT00688467|O2|Outcome|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
1052423|NCT00688467|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
1052424|NCT00688467|E2|Reported Event|Placebo|Placebo 30 mg capsule to be taken by mouth once daily in the morning for 10 days
1052425|NCT00688467|E1|Reported Event|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 10 days
1052426|NCT00688103|B3|Baseline|Total|Total of all reporting groups
1052427|NCT00688103|B2|Baseline|ETN+MTX|Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)
1052428|NCT00688103|B1|Baseline|ETN Alone|Etanercept alone treatment group (25mg, twice/week, s.c.)
1052429|NCT00688103|P2|Participant Flow|ETN+MTX|Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)
1052430|NCT00688103|P1|Participant Flow|ETN Alone|Etanercept alone treatment group (25mg, twice/week, s.c.)
1052431|NCT00688103|O2|Outcome|ETN+MTX|"etanercept (25mg, twice/week, s.c.) combined with methotrexate (6-8mg/week)~ETN+MTX: etanercept (25 mg, twice/week, s.c.) combined with methotrexate (6-8 mg/week)"
1052432|NCT00688103|O1|Outcome|ETN Alone|"etanercept (25mg, twice/week, s.c.)~ETN Alone: etanercept (25 mg, twice/week, s.c.)"
1052433|NCT00688103|O2|Outcome|ETN+MTX|Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)
1052434|NCT00688103|O1|Outcome|ETN Alone|Etanercept alone treatment group (25mg, twice/week, s.c.)
1052435|NCT00688103|O2|Outcome|ETN+MTX|Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)
1052436|NCT00688103|O1|Outcome|ETN Alone|Etanercept alone treatment group (25mg, twice/week, s.c.)
1052437|NCT00688103|E2|Reported Event|ETN+MTX|Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)
1052438|NCT00688103|E1|Reported Event|ETN Alone|Etanercept alone treatment group (25mg, twice/week, s.c.)
1052439|NCT00688064|B3|Baseline|Total|Total of all reporting groups
1052440|NCT00688064|B2|Baseline|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
1052441|NCT00688064|B1|Baseline|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
1052442|NCT00688064|P2|Participant Flow|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
1052443|NCT00688064|P1|Participant Flow|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
1052444|NCT00688064|O2|Outcome|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
1052445|NCT00688064|O1|Outcome|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
1052446|NCT00688064|O2|Outcome|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
1052447|NCT00688064|O1|Outcome|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
1052448|NCT00688064|O2|Outcome|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
1052449|NCT00688064|O1|Outcome|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
1052450|NCT00688064|O2|Outcome|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
1052451|NCT00688064|O1|Outcome|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
1052452|NCT00688064|O2|Outcome|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
1052453|NCT00688064|O1|Outcome|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
1052454|NCT00688064|E2|Reported Event|Vehicle + Doxycycline|Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet
1052455|NCT00688064|E1|Reported Event|Adapalene-BPO + Doxycycline|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.
1052456|NCT00687973|B3|Baseline|Total|Total of all reporting groups
1052457|NCT00687973|B2|Baseline|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
1052458|NCT00687973|B1|Baseline|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
1052459|NCT00687973|P2|Participant Flow|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
1052584|NCT00687609|B1|Baseline|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
1052460|NCT00687973|P1|Participant Flow|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
1052461|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
1052462|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
1052463|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
1052464|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
1052465|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
1052466|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
1052467|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
1052468|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
1052469|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
1052470|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
1052471|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
1052472|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
1052473|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
1052474|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
1052475|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
1052476|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
1052477|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
1052478|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
1052479|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
1052480|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
1052481|NCT00687973|O2|Outcome|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
1052482|NCT00687973|O1|Outcome|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
1054310|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
1052483|NCT00687973|E3|Reported Event|Atenolol/Amlodipine 100/10 mg|Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
1052484|NCT00687973|E2|Reported Event|Valsartan/Amlodipine 160/10 mg|Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
1052485|NCT00687973|E1|Reported Event|Amlodipine 5 mg|Run-in: Amlodipine 5 mg
1052486|NCT00687908|B3|Baseline|Total|Total of all reporting groups
1052487|NCT00687908|B2|Baseline|Vehicle|Vehicle Gel
1052488|NCT00687908|B1|Baseline|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
1052489|NCT00687908|P2|Participant Flow|Vehicle|Vehicle Gel
1052490|NCT00687908|P1|Participant Flow|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
1052491|NCT00687908|O2|Outcome|Vehicle|Vehicle Gel
1052492|NCT00687908|O1|Outcome|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
1052493|NCT00687908|O2|Outcome|Vehicle|Vehicle Gel
1052494|NCT00687908|O1|Outcome|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
1052495|NCT00687908|O2|Outcome|Vehicle|Vehicle Gel
1052496|NCT00687908|O1|Outcome|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
1052497|NCT00687908|O2|Outcome|Vehicle|Vehicle Gel
1052498|NCT00687908|O1|Outcome|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
1052499|NCT00687908|O2|Outcome|Vehicle|Vehicle Gel
1052500|NCT00687908|O1|Outcome|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
1052501|NCT00687908|E2|Reported Event|Vehicle|Vehicle Gel
1052502|NCT00687908|E1|Reported Event|Adapalene-BPO|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
1052503|NCT00687856|B1|Baseline|LVAD Recipients|"Participants who have had or are about to have a left ventricular assist device (LVAD) implanted~Echocardiogram (echo): Participants will undergo a series of echoes to determine if they are eligible to be weaned from LVAD support. Each echo exam will involve the use of an ultrasound probe on the chest of participants to assess the pumping ability of their hearts."
1052504|NCT00687856|P1|Participant Flow|LVAD Recipients|"Participants who have had or are about to have a left ventricular assist device (LVAD) implanted~Echocardiogram (echo): Participants will undergo a series of echoes to determine if they are eligible to be weaned from LVAD support. Each echo exam will involve the use of an ultrasound probe on the chest of participants to assess the pumping ability of their hearts."
1052505|NCT00687856|O1|Outcome|LVAD Recipients|"Participants who have had or are about to have a left ventricular assist device (LVAD) implanted~Echocardiogram (echo): Participants will undergo a series of echoes to determine if they are eligible to be weaned from LVAD support. Each echo exam will involve the use of an ultrasound probe on the chest of participants to assess the pumping ability of their hearts."
1052506|NCT00687856|E1|Reported Event|LVAD Recipients|"Participants who have had or are about to have a left ventricular assist device (LVAD) implanted~Echocardiogram (echo): Participants will undergo a series of echoes to determine if they are eligible to be weaned from LVAD support. Each echo exam will involve the use of an ultrasound probe on the chest of participants to assess the pumping ability of their hearts."
1052507|NCT00687830|B3|Baseline|Total|Total of all reporting groups
1052508|NCT00687830|B2|Baseline|Morning|Bowel prep given on the morning of the day of the afternoon colonoscopy
1052509|NCT00687830|B1|Baseline|Evening|Bowel prep given in the evening prior to the day of the afternoon colonoscopy
1052510|NCT00687830|P2|Participant Flow|Morning|Bowel prep given on the morning of the day of the afternoon colonoscopy
1052511|NCT00687830|P1|Participant Flow|Evening|Bowel prep given in the evening prior to the day of the afternoon colonoscopy
1052512|NCT00687830|O2|Outcome|Morning|Bowel prep given on the morning of the day of the afternoon colonoscopy
1052513|NCT00687830|O1|Outcome|Evening|Bowel prep given in the evening prior to the day of the afternoon colonoscopy
1052514|NCT00687830|O2|Outcome|Morning|Bowel prep given on the morning of the day of the afternoon colonoscopy
1052515|NCT00687830|O1|Outcome|Evening|Bowel prep given in the evening prior to the day of the afternoon colonoscopy
1052516|NCT00687830|E2|Reported Event|Morning|Bowel prep given on the morning of the day of the afternoon colonoscopy
1052517|NCT00687830|E1|Reported Event|Evening|Bowel prep given in the evening prior to the day of the afternoon colonoscopy
1052518|NCT00687804|B4|Baseline|Total|Total of all reporting groups
1052519|NCT00687804|B3|Baseline|Laser|"Laser photocoagulation treatment was administered on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
1052520|NCT00687804|B2|Baseline|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
1052585|NCT00687609|P1|Participant Flow|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
1052586|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
1052587|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
1052521|NCT00687804|B1|Baseline|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
1052522|NCT00687804|P3|Participant Flow|Laser|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
1052523|NCT00687804|P2|Participant Flow|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
1052524|NCT00687804|P1|Participant Flow|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
1052525|NCT00687804|O3|Outcome|Active Laser|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
1052526|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
1052527|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
1052550|NCT00687804|O3|Outcome|Laser|"Laser photocoagulation treatment was administered on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
1052528|NCT00687804|O3|Outcome|Active Laser|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
1052529|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
1052530|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
1052531|NCT00687804|O4|Outcome|Laser Without Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
1052532|NCT00687804|O3|Outcome|Laser With Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
1052533|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
1052534|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
1052573|NCT00687713|O2|Outcome|Placebo|"Subjects received a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Placebo: Placebo"
1052574|NCT00687713|O1|Outcome|Bupropion|"Subjects received bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Bupropion: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper."
1052535|NCT00687804|O4|Outcome|Laser Without Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
1052536|NCT00687804|O3|Outcome|Laser With Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
1052537|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
1052538|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
1052539|NCT00687804|O4|Outcome|Laser Without Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
1052540|NCT00687804|O3|Outcome|Laser With Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
1052541|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
1052575|NCT00687713|E2|Reported Event|Placebo|"Subjects received a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Placebo: Placebo"
1052588|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
1054352|NCT00683774|B3|Baseline|Total|Total of all reporting groups
1052542|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
1052543|NCT00687804|O4|Outcome|Laser Without Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
1052544|NCT00687804|O3|Outcome|Laser With Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
1052545|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
1052546|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
1052547|NCT00687804|O3|Outcome|Laser|"Laser photocoagulation treatment was administered on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
1052548|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
1052549|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
1052589|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
1052551|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
1052552|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
1052553|NCT00687804|O3|Outcome|Laser|"Laser photocoagulation treatment was administered on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
1052554|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
1052555|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
1052556|NCT00687804|O3|Outcome|Laser|"Laser photocoagulation treatment was administered on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
1052557|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
1052558|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
1052559|NCT00687804|O3|Outcome|Laser|"Laser photocoagulation treatment was administered on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
1052576|NCT00687713|E1|Reported Event|Bupropion|"Subjects received bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Bupropion: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper."
1052577|NCT00687674|B1|Baseline|Sorafenib + Lenalidomide + Dexamethasone|
1052578|NCT00687674|P1|Participant Flow|Sorafenib + Lenalidomide + Dexamethasone|
1052560|NCT00687804|O2|Outcome|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
1052561|NCT00687804|O1|Outcome|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes."
1052562|NCT00687804|E4|Reported Event|Laser Without Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
1052563|NCT00687804|E3|Reported Event|Laser With Ranibizumab in Extension|"Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
1052564|NCT00687804|E2|Reported Event|Ranibizumab 0.5 mg + Laser|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy"
1052565|NCT00687804|E1|Reported Event|Ranibizumab 0.5 mg|"Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:~Improvement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA > 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.~Patients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.~Active/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.~In the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."
1052566|NCT00687713|B3|Baseline|Total|Total of all reporting groups
1052567|NCT00687713|B2|Baseline|Placebo|"Subjects received a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Placebo: Placebo"
1052568|NCT00687713|B1|Baseline|Bupropion|"Subjects received bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Bupropion: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper."
1052569|NCT00687713|P2|Participant Flow|Placebo|"Subjects received a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Placebo: Placebo"
1052570|NCT00687713|P1|Participant Flow|Bupropion|"Subjects received bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Bupropion: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper."
1052571|NCT00687713|O2|Outcome|Placebo|"Subjects will receive a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Placebo: Placebo"
1052572|NCT00687713|O1|Outcome|Bupropion|"Subjects will receive bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.~Bupropion: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper."
1052579|NCT00687674|O1|Outcome|Sorafenib + Lenalidomide + Dexamethasone|
1052580|NCT00687674|O1|Outcome|Sorafenib + Lenalidomide + Dexamethasone|
1052590|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
1052591|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
1052592|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
1052593|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
1052594|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
1052595|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
1052596|NCT00687609|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
1052597|NCT00687609|E1|Reported Event|Atomoxetine|0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
1052598|NCT00687544|B1|Baseline|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
1052599|NCT00687544|P1|Participant Flow|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
1052600|NCT00687544|O1|Outcome|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
1052601|NCT00687544|O1|Outcome|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
1052602|NCT00687544|O1|Outcome|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
1052603|NCT00687544|O1|Outcome|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
1052604|NCT00687544|O1|Outcome|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
1052605|NCT00687544|O1|Outcome|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
1052606|NCT00687544|E1|Reported Event|PEG-IFN + RBV|Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
1052607|NCT00687531|B1|Baseline|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
1052608|NCT00687531|P1|Participant Flow|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
1052609|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
1052610|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
1052611|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
1052612|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
1052613|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
1052614|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
1052615|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
1052616|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
1052617|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
1052618|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
1052619|NCT00687531|O1|Outcome|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
1052620|NCT00687531|E1|Reported Event|Mometasone Furoate|Mometasone Furoate 400 mcg once daily in the evening through 12 weeks.
1052621|NCT00687453|B3|Baseline|Total|Total of all reporting groups
1052622|NCT00687453|B2|Baseline|NPH Twice-daily|Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively
1052623|NCT00687453|B1|Baseline|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
1052624|NCT00687453|P2|Participant Flow|NPH Twice-daily|Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively
1052625|NCT00687453|P1|Participant Flow|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
1052626|NCT00687453|O2|Outcome|NPH Twice-daily|Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively
1052627|NCT00687453|O1|Outcome|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
1052628|NCT00687453|E2|Reported Event|NPH Twice-daily|Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively
1052629|NCT00687453|E1|Reported Event|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
1052630|NCT00687440|B1|Baseline|Caelyx, Docetaxel, Trastuzumab|"Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx.~Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab."
1052679|NCT00687193|B4|Baseline|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
1052680|NCT00687193|B3|Baseline|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
1052631|NCT00687440|P1|Participant Flow|Caelyx, Docetaxel, Trastuzumab|"Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx.~Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab."
1052632|NCT00687440|O1|Outcome|Caelyx, Docetaxel, Trastuzumab|"Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx.~Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab."
1052633|NCT00687440|E1|Reported Event|Caelyx, Docetaxel, Trastuzumab|
1052634|NCT00687401|B1|Baseline|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
1052635|NCT00687401|P1|Participant Flow|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
1052636|NCT00687401|O2|Outcome|Per Protocol Population|Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
1052637|NCT00687401|O1|Outcome|Intent to Treat Population|Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
1052638|NCT00687401|E1|Reported Event|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
1052639|NCT00687362|B1|Baseline|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
1052640|NCT00687362|P1|Participant Flow|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
1052641|NCT00687362|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
1052642|NCT00687362|E1|Reported Event|Infliximab 5 mg/kg|Infliximab 5 mg/kg of body weight given as an infusion at Weeks 0, 2, 6, 14, and 22.
1052643|NCT00687323|B1|Baseline|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
1052644|NCT00687323|P1|Participant Flow|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
1052645|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
1052646|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
1052647|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
1052648|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
1052649|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
1052650|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
1052651|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
1052652|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
1052653|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
1054416|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
1052654|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
1052655|NCT00687323|O1|Outcome|Temozolomide|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
1052656|NCT00687323|E1|Reported Event|TEMOZOLOMIDE|Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum).
1052657|NCT00687297|B3|Baseline|Total|Total of all reporting groups
1052658|NCT00687297|B2|Baseline|Randomized to Placebo Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: Placebo 3 tablets daily until progression [1 Cycle= 28 days]
1052659|NCT00687297|B1|Baseline|Randomized to Vandetanib Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: vandetanib (300mg) daily until progression [1 Cycle= 28 days]
1052660|NCT00687297|P2|Participant Flow|Randomized to Placebo Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: Placebo 3 tablets daily until progression [1 Cycle= 28 days]
1052661|NCT00687297|P1|Participant Flow|Randomized to Vandetanib Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: vandetanib (300mg) daily until progression [1 Cycle= 28 days]
1052662|NCT00687297|O2|Outcome|Randomized to Placebo Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: Placebo 3 tablets daily until progression [1 Cycle= 28 days]
1052663|NCT00687297|O1|Outcome|Randomized to Vandetanib Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: vandetanib (300mg) daily until progression [1 Cycle= 28 days]
1052664|NCT00687297|O2|Outcome|Randomized to Placebo Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: Placebo 3 tablets daily until progression [1 Cycle= 28 days]
1052665|NCT00687297|O1|Outcome|Randomized to Vandetanib Maintenance|Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: vandetanib (300mg) daily until progression [1 Cycle= 28 days]
1052666|NCT00687297|O1|Outcome|All Randomized Patients|All patients enrolled in the study
1052667|NCT00687297|E3|Reported Event|All Treated Patients - Induction|Adverse events occurring during induction among all treated patients
1052668|NCT00687297|E2|Reported Event|Treated on Placebo Maintenance|Adverse events among patients receiving placebo during the maintenance phase of the study
1052669|NCT00687297|E1|Reported Event|Treated on Vandetanib Maintenance|Adverse events among patients receiving Vandetanib using the maintenance phase of the study
1052670|NCT00687219|B1|Baseline|Peginterferon Alfa-2b + Ribavirin|"Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day~for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL for 48 weeks"
1052671|NCT00687219|P1|Participant Flow|Peginterferon Alfa-2b + Ribavirin|"Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day~for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL for 48 weeks"
1052672|NCT00687219|O1|Outcome|Peginterferon Alfa-2b + Ribavirin|"Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day~for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL for 48 weeks"
1052673|NCT00687219|O1|Outcome|Peginterferon Alfa-2b + Ribavirin|"Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day~for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL for 48 weeks"
1052674|NCT00687219|O1|Outcome|Peginterferon Alfa-2b + Ribavirin|"Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day~for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL for 48 weeks"
1052675|NCT00687219|E1|Reported Event|Peginterferon Alfa-2b + Ribavirin|"Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day~for subjects with hemoglobin value at screening >=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening >=12g/dL and <14g/dL for 48 weeks"
1052676|NCT00687193|B7|Baseline|Total|Total of all reporting groups
1052677|NCT00687193|B6|Baseline|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1052678|NCT00687193|B5|Baseline|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
1054417|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
1052681|NCT00687193|B2|Baseline|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
1052682|NCT00687193|B1|Baseline|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
1052683|NCT00687193|P6|Participant Flow|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1052684|NCT00687193|P5|Participant Flow|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
1052685|NCT00687193|P4|Participant Flow|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
1052686|NCT00687193|P3|Participant Flow|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
1052687|NCT00687193|P2|Participant Flow|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
1052688|NCT00687193|P1|Participant Flow|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
1052689|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1052690|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
1052691|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
1052692|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
1052693|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
1052694|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
1052695|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1052696|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
1052697|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
1052698|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
1052699|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
1052700|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
1052701|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1052702|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
1052703|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
1052704|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
1052705|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
1052706|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
1052707|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1052708|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
1052709|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
1052710|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
1052711|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
1052712|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
1052713|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1052714|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
1052715|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
1052716|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
1052717|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
1052718|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
1052719|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1052720|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
1052721|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
1052722|NCT00687193|O3|Outcome|CP-690,550 5 mg BID|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
1052723|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
1052724|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
1052725|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1052726|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
1052727|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
1052728|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
1052729|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
1052730|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks
1052731|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1052732|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
1052733|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
1052734|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
1052735|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
1052736|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
1052737|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1052738|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
1052739|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
1052740|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
1052741|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
1052742|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
1052743|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1052744|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
1052745|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
1052746|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
1052747|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
1052748|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
1052749|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1052750|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
1052751|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
1052752|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
1052753|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
1052754|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
1052755|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1052756|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
1052757|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
1052758|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
1052759|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
1052760|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
1052761|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1052762|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
1052763|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
1052764|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
1052765|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
1052766|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
1052767|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1052768|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
1052769|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
1052770|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
1052771|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
1052772|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
1052773|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1052774|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
1052775|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
1052776|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
1052777|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
1052778|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
1052779|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1052780|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
1052781|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
1052782|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
1052783|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
1052784|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
1052785|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1052786|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
1052787|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
1052788|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
1052789|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
1052790|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
1052791|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1052792|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
1052793|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
1052794|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
1052795|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
1052796|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
1052797|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1052798|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
1052799|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
1052800|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
1052801|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
1052802|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
1052803|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1052804|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
1052805|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
1052806|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
1052807|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
1052808|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
1052809|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1052810|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
1052811|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
1052812|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
1052813|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
1052814|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks. Missing values were not imputed.
1052815|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1052816|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
1052817|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
1052818|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
1052819|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
1052820|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
1052821|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1052822|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
1052823|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
1052824|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
1052825|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
1052826|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
1052827|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1052828|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
1052829|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
1052830|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
1052831|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
1054418|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
1052832|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
1052833|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1052834|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
1052835|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
1052836|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
1052837|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
1052838|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
1052839|NCT00687193|O6|Outcome|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1052840|NCT00687193|O5|Outcome|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
1052841|NCT00687193|O4|Outcome|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
1052842|NCT00687193|O3|Outcome|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
1052843|NCT00687193|O2|Outcome|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
1052844|NCT00687193|O1|Outcome|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
1052845|NCT00687193|E6|Reported Event|Placebo|Participants were administered placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1052846|NCT00687193|E5|Reported Event|CP-690,550 15 mg|Participants were administered 15 mg of CP-690,550 orally twice daily for 12 weeks.
1052847|NCT00687193|E4|Reported Event|CP-690,550 10 mg|Participants were administered 10 mg of CP-690,550 orally twice daily for 12 weeks.
1052848|NCT00687193|E3|Reported Event|CP-690,550 5 mg|Participants were administered 5 mg of CP-690,550 orally twice daily for 12 weeks.
1052849|NCT00687193|E2|Reported Event|CP-690,550 3 mg|Participants were administered 3 mg of CP-690,550 orally twice daily for 12 weeks.
1052850|NCT00687193|E1|Reported Event|CP-690,550 1 mg|Participants were administered 1 milligram (mg) of CP-690,550 orally twice daily for 12 weeks.
1052851|NCT00686166|B1|Baseline|Chemo + Chemo and Radiation + Surgery|"Chemotherapy Cycle 1 (1 cycle is 35 days):~Oxaliplatin, 50 mg/m^2, IV, Days 1,8,15,22,29~Cetuximab, 400 mg/m^2, IV, Day 1~Cetuximab, 250 mg/m^2, IV, Days 8,15,22,29~Capecitabine, 1650 mg/m^2/day, PO, Monday-Friday (Day 1-35)~Chemotherapy+ Radiation Cycle 2:~Oxaliplatin, 50 mg/m^2, IV, Days 50,57,71,78~Cetuximab, 250 mg/m^2, IV, Days 50,57,64,71,78~Capecitabine, 1650 mg/m^1, PO, Monday-Friday (Day 50-84)~Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.~Therapeutic Surgical procedure: Resection"
1052852|NCT00686166|P1|Participant Flow|Chemo + Chemo and Radiation + Surgery|"Chemotherapy Cycle 1 (1 cycle is 35 days):~Oxaliplatin, 50 mg/m^2, IV, Days 1,8,15,22,29~Cetuximab, 400 mg/m^2, IV, Day 1~Cetuximab, 250 mg/m^2, IV, Days 8,15,22,29~Capecitabine, 1650 mg/m^2/day, PO, Monday-Friday (Day 1-35)~Chemotherapy+ Radiation Cycle 2:~Oxaliplatin, 50 mg/m^2, IV, Days 50,57,71,78~Cetuximab, 250 mg/m^2, IV, Days 50,57,64,71,78~Capecitabine, 1650 mg/m^1, PO, Monday-Friday (Day 50-84)~Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.~Therapeutic Surgical procedure: Resection"
1052853|NCT00686166|O3|Outcome|Tumor Resection|Surgery must take place between 3 – 8 weeks after completion of chemoradiation. Surgical resections should adhere to the principles of total mesorectal excision as described by Heald.
1052854|NCT00686166|O2|Outcome|Chemotherapy + Radiation|Patients receive oxaliplatin 50 mg/m^2 IV (Days 50, 57, 71, 78), cetuximab 250 mg/m^2 IV (Days 50, 57, 64, 71, 78), capecitabine 1650 mg/m^2 PO (Monday-Friday, Day 50-84). Radiation therapy begins on Day 50. Dose and length of treatment are dependent on technique used and clinical stage. Planned target value 1: 4500 cGy (centigray) in 25 fractions; Planned target value 2 (stage 3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.
1052855|NCT00686166|O1|Outcome|Chemotherapy|Patients receive oxaliplatin 50 mg/m^2 IV (Days 1, 8, 15, 22, 29), cetuximab 400 mg/m^2 IV (Day 1), cetuximab 250 mg/m^2 IV (Days 8, 15, 22, 29), capecitabine 1650 mg/m^2 PO (Monday-Friday, Day 1-35). Cycle is 35 days, followed by a 14-day break.
1052856|NCT00686166|O1|Outcome|Chemo + Chemo and Radiation + Surgery|"Chemotherapy Cycle 1 (1 cycle is 35 days):~Oxaliplatin, 50 mg/m^2, IV, Days 1,8,15,22,29~Cetuximab, 400 mg/m^2, IV, Day 1~Cetuximab, 250 mg/m^2, IV, Days 8,15,22,29~Capecitabine, 1650 mg/m^2/day, PO, Monday-Friday (Day 1-35)~Chemotherapy+ Radiation Cycle 2:~Oxaliplatin, 50 mg/m^2, IV, Days 50,57,71,78~Cetuximab, 250 mg/m^2, IV, Days 50,57,64,71,78~Capecitabine, 1650 mg/m^1, PO, Monday-Friday (Day 50-84)~Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.~Therapeutic Surgical procedure: Resection"
1052857|NCT00686166|O1|Outcome|Chemo + Chemo and Radiation + Surgery|"Chemotherapy Cycle 1 (1 cycle is 35 days):~Oxaliplatin, 50 mg/m^2, IV, Days 1,8,15,22,29~Cetuximab, 400 mg/m^2, IV, Day 1~Cetuximab, 250 mg/m^2, IV, Days 8,15,22,29~Capecitabine, 1650 mg/m^2/day, PO, Monday-Friday (Day 1-35)~Chemotherapy+ Radiation Cycle 2:~Oxaliplatin, 50 mg/m^2, IV, Days 50,57,71,78~Cetuximab, 250 mg/m^2, IV, Days 50,57,64,71,78~Capecitabine, 1650 mg/m^1, PO, Monday-Friday (Day 50-84)~Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.~Therapeutic Surgical procedure: Resection"
1052858|NCT00686166|E3|Reported Event|Tumor Resection|Surgery must take place between 3 – 8 weeks after completion of chemoradiation. Surgical resections should adhere to the principles of total mesorectal excision as described by Heald.
1052899|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052900|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
1052859|NCT00686166|E2|Reported Event|Chemotherapy + Radiation|Patients receive oxaliplatin 50 mg/m^2 IV (Days 50, 57, 71, 78), cetuximab 250 mg/m^2 IV (Days 50, 57, 64, 71, 78), capecitabine 1650 mg/m^2 PO (Monday-Friday, Day 50-84). Radiation therapy begins on Day 50. Dose and length of treatment are dependent on technique used and clinical stage. Planned target value 1: 4500 cGy (centigray) in 25 fractions; Planned target value 2 (stage 3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.
1052860|NCT00686166|E1|Reported Event|Chemotherapy|Patients receive oxaliplatin 50 mg/m^2 IV (Days 1, 8, 15, 22, 29), cetuximab 400 mg/m^2 IV (Day 1), cetuximab 250 mg/m^2 IV (Days 8, 15, 22, 29), capecitabine 1650 mg/m^2 PO (Monday-Friday, Day 1-35). Cycle is 35 days, followed by a 14-day break.
1052861|NCT00686127|B3|Baseline|Total|Total of all reporting groups
1052862|NCT00686127|B2|Baseline|Placebo Patch|Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day.
1052863|NCT00686127|B1|Baseline|Lidocaine Patch|Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.): 1 patch was applied topically to the affected site(s) for 12 hours each day.
1052864|NCT00686127|P2|Participant Flow|Placebo Patch|Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day.
1052865|NCT00686127|P1|Participant Flow|Lidocaine Patch|Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.), 1 patch was applied topically to the affected site(s) for 12 hours each day.
1052866|NCT00686127|O2|Outcome|Placebo Patch|Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day.
1052867|NCT00686127|O1|Outcome|Lidocaine Patch|Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.): 1 patch was applied topically to the affected site(s) for 12 hours each day.
1052868|NCT00686127|E2|Reported Event|Placebo Patch|Placebo patch: Patch is changed every 24 hours
1052869|NCT00686127|E1|Reported Event|Lidocaine Patch|Lidocaine patch One patch is changed every twenty-four hours
1052870|NCT00686075|B11|Baseline|Total|Total of all reporting groups
1052871|NCT00686075|B10|Baseline|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052872|NCT00686075|B9|Baseline|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052873|NCT00686075|B8|Baseline|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052874|NCT00686075|B7|Baseline|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052875|NCT00686075|B6|Baseline|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1052876|NCT00686075|B5|Baseline|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1052877|NCT00686075|B4|Baseline|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052878|NCT00686075|B3|Baseline|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052879|NCT00686075|B2|Baseline|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052880|NCT00686075|B1|Baseline|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
1052881|NCT00686075|P10|Participant Flow|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052882|NCT00686075|P9|Participant Flow|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052883|NCT00686075|P8|Participant Flow|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052884|NCT00686075|P7|Participant Flow|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052885|NCT00686075|P6|Participant Flow|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1052886|NCT00686075|P5|Participant Flow|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1052887|NCT00686075|P4|Participant Flow|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052888|NCT00686075|P3|Participant Flow|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052889|NCT00686075|P2|Participant Flow|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052890|NCT00686075|P1|Participant Flow|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
1052891|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052892|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052893|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052894|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052895|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1052896|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1052897|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052898|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1054419|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
1052901|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052902|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052903|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052904|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052905|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1052906|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1052907|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052908|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052909|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052910|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
1052911|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052912|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052913|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052914|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052915|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1052916|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1052917|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052918|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052919|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052920|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
1052921|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052922|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052923|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052924|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052925|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1052926|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1052927|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052928|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052929|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052930|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
1052931|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052932|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052933|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052934|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052935|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1052936|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1052937|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052938|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052939|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052940|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
1052941|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1054420|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
1052942|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052943|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052944|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052945|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1052946|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1052947|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052948|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052949|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052950|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
1052951|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052952|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052953|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052954|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052955|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1052956|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1052957|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052958|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052959|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052960|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
1052961|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052962|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052963|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052964|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052965|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1052966|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1052967|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052968|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052969|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052970|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
1052971|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052972|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052973|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052974|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052975|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1052976|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1052977|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052978|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052979|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052980|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
1052981|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052982|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1054421|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
1052983|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052984|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052985|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1052986|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1052987|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052988|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052989|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052990|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
1052991|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052992|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052993|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052994|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1052995|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1052996|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1052997|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052998|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1052999|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1053000|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
1053001|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1053002|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1053003|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1053004|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1053005|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1053006|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1053007|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1053008|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1053009|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1053010|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
1053011|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1053012|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1053013|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1053014|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1053015|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1053016|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1053017|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1053018|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1053019|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1053020|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
1053021|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1053022|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1053023|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1054422|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
1053024|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1053025|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1053026|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1053027|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1053028|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1053029|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1053030|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
1053031|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1053032|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1053033|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1053034|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1053035|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1053036|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1053037|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1053038|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1053039|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1053040|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
1053041|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1053042|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1053043|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1053044|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1053045|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1053046|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1053047|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1053048|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1053049|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1053050|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
1053051|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1053052|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1053053|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1053054|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1053055|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1053056|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1053057|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1053058|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1053059|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1053060|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
1053061|NCT00686075|O10|Outcome|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1053062|NCT00686075|O9|Outcome|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1053063|NCT00686075|O8|Outcome|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1053064|NCT00686075|O7|Outcome|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1054423|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
1053065|NCT00686075|O6|Outcome|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1053066|NCT00686075|O5|Outcome|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1053067|NCT00686075|O4|Outcome|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1053068|NCT00686075|O3|Outcome|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1053069|NCT00686075|O2|Outcome|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1053070|NCT00686075|O1|Outcome|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
1053071|NCT00686075|E10|Reported Event|Placebo, Cohort 5|Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1053072|NCT00686075|E9|Reported Event|MEDI-534, Cohort 5|Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1053073|NCT00686075|E8|Reported Event|Placebo, Cohort 4|Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1053074|NCT00686075|E7|Reported Event|MEDI-534, Cohort 4|Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1053075|NCT00686075|E6|Reported Event|Placebo, Cohort 3|Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1053076|NCT00686075|E5|Reported Event|MEDI-534, Cohort 3|Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
1053077|NCT00686075|E4|Reported Event|Placebo, Cohort 2|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1053078|NCT00686075|E3|Reported Event|MEDI-534, Cohort 2|Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
1053079|NCT00686075|E2|Reported Event|Placebo, Cohort 1|Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
1053080|NCT00686075|E1|Reported Event|MEDI-534, Cohort 1|Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
1053081|NCT00686036|B3|Baseline|Total|Total of all reporting groups
1053082|NCT00686036|B2|Baseline|Placebo|Placebo to match vandetanib 300 mg tablet
1053083|NCT00686036|B1|Baseline|Vandetanib|Vandetanib 300 mg tablet
1053084|NCT00686036|P2|Participant Flow|Placebo|Placebo to match vandetanib 300 mg tablet
1053085|NCT00686036|P1|Participant Flow|Vandetanib|Vandetanib 300 mg tablet
1053086|NCT00686036|O2|Outcome|Placebo|Placebo to match vandetanib 300 mg tablet
1053087|NCT00686036|O1|Outcome|Vandetanib|Vandetanib 300 mg tablet
1053088|NCT00686036|O2|Outcome|Placebo|Placebo to match vandetanib 300 mg tablet
1053089|NCT00686036|O1|Outcome|Vandetanib|Vandetanib 300 mg tablet
1053090|NCT00686036|O2|Outcome|Placebo|Placebo to match vandetanib 300 mg tablet
1053091|NCT00686036|O1|Outcome|Vandetanib|Vandetanib 300 mg tablet
1053092|NCT00686036|O2|Outcome|Placebo|Placebo to match vandetanib 300 mg tablet
1053093|NCT00686036|O1|Outcome|Vandetanib|Vandetanib 300 mg tablet
1053094|NCT00686036|E2|Reported Event|Placebo|Placebo to match vandetanib 300 mg tablet
1053095|NCT00686036|E1|Reported Event|Vandetanib|Vandetanib 300 mg tablet
1053096|NCT00685945|B1|Baseline|All Participants|Subjects characteristics for all 24 participants
1053097|NCT00685945|P1|Participant Flow|All Participants|24 subjects received a bradykinin infusion and then a bradykinin + L-NMMA infusion. Subjects were then randomized to receive either isosorbide (N=12) or sildenafil (N=12). The infusion of bradykinin + L-NMMA was then repeated.
1053098|NCT00685945|O4|Outcome|Sildenafil + L-NMMA + Control|Twelve (of the twenty-four) subjects received sildenafil after completing the bradykinin and bradykinin plus L-NMMA infusions. After 1 hour, bradykinin plus L-NMMA infusions were repeated.
1053099|NCT00685945|O3|Outcome|Isosorbide + L-NMMA + Control|Twelve (of the twenty-four)subjects received isosorbide after completing the bradykinin and bradykinin plus L-NMMA infusions. The bradykinin plus L-NMMA infusions were then repeated.
1053100|NCT00685945|O2|Outcome|L-NMMA + Control|Subjects received a continuous infusion of L-NMMA plus bradykinin at 50, 100 and 200ng/min
1053101|NCT00685945|O1|Outcome|Control|Subjects received bradykinin at 50, 100 and 200ng/min
1053102|NCT00685945|O4|Outcome|Sildenafil + L-NMMA + Control|Twelve (of the twenty-four) subjects received sildenafil after completing the bradykinin and bradykinin plus L-NMMA infusions. After 1 hour, bradykinin plus L-NMMA infusions were repeated.
1053103|NCT00685945|O3|Outcome|Isosorbide + L-NMMA + Control|Twelve (of the twenty-four)subjects received isosorbide after completing the bradykinin and bradykinin plus L-NMMA infusions. The bradykinin plus L-NMMA infusions were then repeated.
1053104|NCT00685945|O2|Outcome|L-NMMA + Control|Subjects received a continuous infusion of L-NMMA plus bradykinin at 50, 100 and 200ng/min
1053105|NCT00685945|O1|Outcome|Control|Subjects received bradykinin at 50, 100 and 200ng/min
1053106|NCT00685945|O4|Outcome|Sildenafil + L-NMMA + Control|Twelve of the twenty-four subjects were randomized to sildenafil after completing the bradykinin and bradykinin plus L-NMMA infusions. After 1 hour, bradykinin plus L-NMMA infusions were repeated.
1053107|NCT00685945|O3|Outcome|Isosorbide + L-NMMA + Control|Eleven of the twenty-four subjects were randomized to isosorbide after completing the bradykinin and bradykinin plus L-NMMA infusions. The bradykinin plus L-NMMA infusions were then repeated.
1053108|NCT00685945|O2|Outcome|L-NMMA + Control|After the intial bradykinin infusion subjects then received a continuous infusion of L-NMMA plus bradykinin at 50, 100 and 200ng/min
1053109|NCT00685945|O1|Outcome|Control|Subjects received bradykinin at 50, 100 and 200ng/min
1053110|NCT00685945|E1|Reported Event|All Participants|Subjects characteristics for all 24 participants
1053168|NCT00686894|E1|Reported Event|Infliximab 5 mg/kg|Infliximab infusions: 5 mg/kg at weeks 0, 2, and 6.
1053111|NCT00687167|B1|Baseline|Zonisamide 100 mg Capsules and Zonegran® 100 mg Capsules|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 29, each subject received one capsule of either zonisamide 100 mg or Zonegran® 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast preceeded by an overnight fast.
1053112|NCT00687167|P2|Participant Flow|Zonegran® 100 mg Capsules Then Zonisamide 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the reference formulation, Zonegran® 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast, followed by a 28 day washout period. On the morning of Day 29 subjects received one capsule of the test formulation, zonisamide 100 mg, 30 minutes after the intiation of a standardized, high-fat breakfast.
1053113|NCT00687167|P1|Participant Flow|Zonisamide 100 mg Capsules Then Zonegran® 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast, followed by a 28 day washout period. On the morning of Day 29 subjects received one capsule of the reference formulation, Zonegran® 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast.
1053114|NCT00687167|O2|Outcome|Zonegran® 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, 30 minutes after the intiation of a standardized, high-fat breakfast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen 30 minutes after the initiation of a standardized, high-fat breakfast.
1053115|NCT00687167|O1|Outcome|Zonisamide 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, 30 minutes after the intiation of a standardized, high-fat breakfast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen 30 minutes after the initiation of a standardized, high-fat breakfast.
1053116|NCT00687167|O2|Outcome|Zonegran® 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, 30 minutes after the intiation of a standardized, high-fat breakfast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen 30 minutes after the initiation of a standardized, high-fat breakfast.
1053117|NCT00687167|O1|Outcome|Zonisamide 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, 30 minutes after the intiation of a standardized, high-fat breakfast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen 30 minutes after the initiation of a standardized, high-fat breakfast.
1053118|NCT00687167|E2|Reported Event|Zonegran® 100 mg Capsules|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 29, each subject received one capsule of either zonisamide 100 mg or Zonegran® 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast preceeded by an overnight fast.
1053119|NCT00687167|E1|Reported Event|Zonisamide 100 mg Capsules|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 29, each subject received one capsule of either zonisamide 100 mg or Zonegran® 100 mg, 30 minutes after the initiation of a standardized, high-fat breakfast preceeded by an overnight fast.
1053120|NCT00687076|B3|Baseline|Total|Total of all reporting groups
1053121|NCT00687076|B2|Baseline|Mono Therapy|"Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Placebo Niaspan: Daily dose of 1500 mg of placebo Niaspan~Placebo Ezetimibe: Daily dose of 10 mg of placebo Ezetimibe~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
1053122|NCT00687076|B1|Baseline|Triple Therapy|"Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan.~Ezetimibe: Daily dose of 10 mg of Ezetimibe~Niaspan: Daily dose of 1500 mg of Niaspan~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
1053123|NCT00687076|P2|Participant Flow|Mono Therapy|"Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Placebo Niaspan: Daily dose of 1500 mg of placebo Niaspan~Placebo Ezetimibe: Daily dose of 10 mg of placebo Ezetimibe~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
1053124|NCT00687076|P1|Participant Flow|Triple Therapy|"Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan.~Ezetimibe: Daily dose of 10 mg of Ezetimibe~Niaspan: Daily dose of 1500 mg of Niaspan~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
1053169|NCT00686881|B3|Baseline|Total|Total of all reporting groups
1053170|NCT00686881|B2|Baseline|SNMC|Participants receiving stronger neo minophagen C (SNMC) 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
1054424|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
1053125|NCT00687076|O2|Outcome|Mono Therapy|"Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Placebo Niaspan: Daily dose of 1500 mg of placebo Niaspan~Placebo Ezetimibe: Daily dose of 10 mg of placebo Ezetimibe~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
1053126|NCT00687076|O1|Outcome|Triple Therapy|"Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan.~Ezetimibe: Daily dose of 10 mg of Ezetimibe~Niaspan: Daily dose of 1500 mg of Niaspan~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
1053127|NCT00687076|O2|Outcome|Mono Therapy|"Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Placebo Niaspan: Daily dose of 1500 mg of placebo Niaspan~Placebo Ezetimibe: Daily dose of 10 mg of placebo Ezetimibe~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
1053128|NCT00687076|O1|Outcome|Triple Therapy|"Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan.~Ezetimibe: Daily dose of 10 mg of Ezetimibe~Niaspan: Daily dose of 1500 mg of Niaspan~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
1053129|NCT00687076|E2|Reported Event|Mono Therapy|"Participants will receive standard of medical care and treatment with standard lipid modifying medications plus placebo Ezetimibe and placebo Niaspan.~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Placebo Niaspan: Daily dose of 1500 mg of placebo Niaspan~Placebo Ezetimibe: Daily dose of 10 mg of placebo Ezetimibe~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
1053130|NCT00687076|E1|Reported Event|Triple Therapy|"Participants will receive standard of medical care and treatment with intensive lipid modification using a statin plus Ezetimibe and Niaspan.~Ezetimibe: Daily dose of 10 mg of Ezetimibe~Niaspan: Daily dose of 1500 mg of Niaspan~Statin therapy: Daily dose of 40 mg of Simvastatin (If unable to tolerate Simvastatin, participants will take a daily dose of Atorvastatin.)~Standard care: Standard of medical care for PAD~Aspirin: Daily dose of 325 mg of aspirin~Clopidogrel: Daily dose of 75 mg of clopidogrel for 3 months or as recommended by the primary care physician~Inclusion criteria were life-style-limiting claudication consistent with Fontaine Stage IIa/IIb or angiographically confirmed Trans-Atlantic Inter-Society Consensus A-C lesions in the SFA."
1053131|NCT00686998|B4|Baseline|Total|Total of all reporting groups
1053132|NCT00686998|B3|Baseline|Olanzapine|Olanzapine 15 mg
1053133|NCT00686998|B2|Baseline|Placebo|Matching Placebo
1053134|NCT00686998|B1|Baseline|AZD2624|AZD2624 40 mg
1053135|NCT00686998|P3|Participant Flow|Olanzapine|Olanzapine 15 mg
1053136|NCT00686998|P2|Participant Flow|Placebo|Matching Placebo
1053137|NCT00686998|P1|Participant Flow|AZD2624|AZD2624 40 mg
1053138|NCT00686998|O3|Outcome|Olanzapine|Olanzapine 15 mg
1053139|NCT00686998|O2|Outcome|Placebo|Placebo
1053140|NCT00686998|O1|Outcome|AZD2624|AZD2624 40 mg
1053141|NCT00686998|E3|Reported Event|Olanzapine|Olanzapine 15 mg
1053142|NCT00686998|E2|Reported Event|Placebo|Matching Placebo
1053143|NCT00686998|E1|Reported Event|AZD2624|AZD2624 40 mg
1053144|NCT00686959|B3|Baseline|Total|Total of all reporting groups
1053145|NCT00686959|B2|Baseline|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
1053146|NCT00686959|B1|Baseline|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
1053147|NCT00686959|P2|Participant Flow|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
1053148|NCT00686959|P1|Participant Flow|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent thoracic radiation therapy (TRT) (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 milligrams per meter squared (mg/m^2), intravenous (IV) on Day 1 of each 21-day cycle for 3 cycles.~Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gray [Gy] per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
1053149|NCT00686959|O2|Outcome|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
1053150|NCT00686959|O1|Outcome|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
1053151|NCT00686959|O2|Outcome|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
1053152|NCT00686959|O1|Outcome|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
1053153|NCT00686959|O2|Outcome|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
1053154|NCT00686959|O1|Outcome|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
1053164|NCT00686959|E1|Reported Event|Arm A:|"Arm A: Participants were treated with pemetrexed plus cisplatin and concurrent thoracic radiation TRT (”Concurrent Phase”) for three 21-day cycles, followed by a 3-5 week “Recovery Period,” then treated with consolidation chemotherapy with pemetrexed (”Consolidation Phase”) for four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles."
1053155|NCT00686959|O2|Outcome|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
1053156|NCT00686959|O1|Outcome|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
1053157|NCT00686959|O2|Outcome|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
1053158|NCT00686959|O1|Outcome|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
1053159|NCT00686959|O2|Outcome|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
1053160|NCT00686959|O1|Outcome|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
1053161|NCT00686959|O2|Outcome|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22"
1053162|NCT00686959|O1|Outcome|Arm A: Pemetrexed + Cisplatin and TRT|"Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT (Concurrent Phase) for three 21-day cycles, followed by a 3-5 week Recovery Period, then treated with consolidation chemotherapy with pemetrexed (Consolidation Phase) for up to four 21-day cycles~Concurrent Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.~Consolidation Phase:~Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles"
1053163|NCT00686959|E2|Reported Event|Arm B: Etoposide + Cisplatin and TRT|"Participants were treated with Etoposide plus Cisplatin and concurrent TRT (Concurrent Phase”) for two 28-day cycles, followed by a 3-5 week “Recovery Period,” then received consolidation treatment with cytotoxic chemotherapy of choice (Consolidation Phase”) for up to 2 cycles~Concurrent Phase:~Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36~Consolidation Phase options:~Option 1: Continue the same treatment plan as Concurrent Phase"
1053165|NCT00686894|B1|Baseline|Infliximab 5 mg/kg|Infliximab infusions: 5 mg/kg at weeks 0, 2, and 6.
1053166|NCT00686894|P1|Participant Flow|Infliximab 5 mg/kg|Infliximab infusions: 5 mg/kg at weeks 0, 2, and 6.
1053171|NCT00686881|B1|Baseline|PegIFN-2b|Participants receiving peginterferon alfa-2b (PegIFN-2b) at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
1053172|NCT00686881|P2|Participant Flow|SNMC|Participants receiving stronger neo minophagen C (SNMC) 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
1053173|NCT00686881|P1|Participant Flow|PegIFN-2b|Participants receiving peginterferon alfa-2b (PegIFN-2b) at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
1053174|NCT00686881|O2|Outcome|SNMC|Participants receiving stronger neo minophagen C (SNMC) 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
1053175|NCT00686881|O1|Outcome|PegIFN-2b|Participants receiving peginterferon alfa-2b (PegIFN-2b) at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
1053176|NCT00686881|O2|Outcome|SNMC|Participants receiving SNMC 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
1053177|NCT00686881|O1|Outcome|PegIFN-2b|Participants receiving PegIFN-2b at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
1053178|NCT00686881|O2|Outcome|SNMC|Participants receiving stronger neo minophagen C (SNMC) 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
1053179|NCT00686881|O1|Outcome|PegIFN-2b|Participants receiving peginterferon alfa-2b (PegIFN-2b) at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks.
1053180|NCT00686881|E2|Reported Event|SNMC|"Participants receiving SNMC 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up~to 156 weeks."
1053181|NCT00686881|E1|Reported Event|PegIFN-2b|"Participants receiving PegIFN-2b at 0.5 ug/kg subcutaneously (SC) once a week for~up to 156 weeks."
1053182|NCT00686855|B3|Baseline|Total|Total of all reporting groups
1053183|NCT00686855|B2|Baseline|Tacrolimus|"Tacrolimus Arm Closed to Accrual as of January 2012~Tacrolimus : Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks"
1053184|NCT00686855|B1|Baseline|Dexamethasone|Dexamethasone : Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks
1053185|NCT00686855|P2|Participant Flow|Tacrolimus|"Tacrolimus Arm Closed to Accrual as of January 2012~Tacrolimus : Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks"
1053186|NCT00686855|P1|Participant Flow|Dexamethasone|Dexamethasone : Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks
1053187|NCT00686855|O2|Outcome|Tacrolimus|"Tacrolimus Arm Closed to Accrual as of January 2012~Tacrolimus : Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks"
1053188|NCT00686855|O1|Outcome|Dexamethasone|Dexamethasone : Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks
1053189|NCT00686855|E2|Reported Event|Tacrolimus|"Tacrolimus Arm Closed to Accrual as of January 2012~Tacrolimus : Tacrolimus elixir taken as an oral rinse four times a day for 4 weeks"
1053190|NCT00686855|E1|Reported Event|Dexamethasone|Dexamethasone : Dexamethasone elixir taken as an oral rinse 4 times a day for 4 weeks
1053191|NCT00686842|B1|Baseline|VEGF Inhibitor PTC299|Single arm study - all subjects received PTC299
1053192|NCT00686842|P1|Participant Flow|VEGF Inhibitor PTC299|Single arm study - all subjects received PTC299
1053193|NCT00686842|O1|Outcome|VEGF Inhibitor PTC299|Single arm study - all subjects received PTC299
1053194|NCT00686842|E1|Reported Event|VEGF Inhibitor PTC299|Single arm study - all subjects received PTC299
1053195|NCT00686803|B4|Baseline|Total|Total of all reporting groups
1053196|NCT00686803|B3|Baseline|Placebo|Placebo
1053197|NCT00686803|B2|Baseline|PL-3994 0.3 µg/kg|PL-3994 0.3 µg/kg
1053198|NCT00686803|B1|Baseline|PL-3994 0.1 µg/kg|PL-3994 0.1 µg/kg
1053199|NCT00686803|P3|Participant Flow|Placebo|Placebo
1053200|NCT00686803|P2|Participant Flow|PL-3994 0.3 µg/kg|PL-3994 0.3 µg/kg
1053201|NCT00686803|P1|Participant Flow|PL-3994 0.1 µg/kg|PL-3994 0.1 µg/kg
1053202|NCT00686803|O3|Outcome|Placebo|Placebo
1053203|NCT00686803|O2|Outcome|PL-3994 0.3 µg/kg|PL-3994 0.3 µg/kg
1053204|NCT00686803|O1|Outcome|PL-3994 0.1 µg/kg|PL-3994 0.1 µg/kg
1053205|NCT00686803|O3|Outcome|Placebo|Placebo
1053206|NCT00686803|O2|Outcome|PL-3994 0.3 µg/kg|PL-3994 0.3 µg/kg
1053207|NCT00686803|O1|Outcome|PL-3994 0.1 µg/kg|PL-3994 0.1 µg/kg
1053208|NCT00686803|E3|Reported Event|Placebo|Placebo
1053209|NCT00686803|E2|Reported Event|PL-3994 0.3 µg/kg|PL-3994 0.3 µg/kg
1053210|NCT00686803|E1|Reported Event|PL-3994 0.1 µg/kg|PL-3994 0.1 µg/kg
1053211|NCT00686790|B1|Baseline|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
1053212|NCT00686790|P1|Participant Flow|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
1053213|NCT00686790|O1|Outcome|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
1053214|NCT00686790|O1|Outcome|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
1053215|NCT00686790|O1|Outcome|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
1053216|NCT00686790|O1|Outcome|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
1053217|NCT00686790|O1|Outcome|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
1053218|NCT00686790|E1|Reported Event|PegIntron|Peginterferon alfa-2b 1.5 mcg/kg/wk SC for 52 weeks
1053219|NCT00686777|B1|Baseline|PEG-IFN + Ribavirin|PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
1053220|NCT00686777|P1|Participant Flow|Pegylated Interferon Alfa-2b (PEG-IFN) + Ribavirin|PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
1053221|NCT00686777|O1|Outcome|PEG-IFN + Ribavirin|PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
1053222|NCT00686777|O1|Outcome|PEG-IFN + Ribavirin|PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
1053309|NCT00686686|P1|Participant Flow|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
1053223|NCT00686777|O1|Outcome|PEG-IFN + Ribavirin|PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
1053224|NCT00686777|E1|Reported Event|PEG-IFN + Ribavirin|PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
1053225|NCT00686725|B3|Baseline|Total|Total of all reporting groups
1053226|NCT00686725|B2|Baseline|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
1053227|NCT00686725|B1|Baseline|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
1053228|NCT00686725|P2|Participant Flow|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
1053229|NCT00686725|P1|Participant Flow|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
1053230|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
1053231|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
1053232|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
1053233|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
1053234|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
1053266|NCT00686712|O3|Outcome|3 - NPH Insulin QHS|"NPH insulin injected subcutaneously once daily at bedtime~NPH insulin injected subcutaneously once daily at bedtime: NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses <120 mg/dL)"
1054425|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
1053235|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
1053236|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
1053237|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
1053238|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
1053239|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
1053240|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
1053241|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
1053242|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
1053243|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
1053244|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
1054426|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
1053245|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
1053246|NCT00686725|O2|Outcome|Temozolomide Alone, Then Temozolomide + Radiation|"Early postsurgery temozolomide chemotherapy plus standard regimen:~Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide + radiation arm (standard therapy regimen).~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
1053247|NCT00686725|O1|Outcome|Temozolomide + Radiation|"Standard therapy regimen:~Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used.~Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks."
1053248|NCT00686725|E2|Reported Event|Temozolomide Alone, Then Temozolomide Radiation|Early postsurgery temozolomide chemotherapy plus standard regimen: Treatment with temozolomide alone will start 2 weeks after surgery at 75 mg/m^2/day orally for 14 days. Then, starting on Day 29 after surgery, temozolomide will be administered according to standard treatment as described for the temozolomide radiation arm (standard therapy regimen). Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
1053249|NCT00686725|E1|Reported Event|Temozolomide Radiation|Standard therapy regimen: Treatment will start 4 weeks after surgery. Temozolomide will be administered concomitantly with radiotherapy, at 75 mg/m^2/day orally for 42 days. Four weeks after completing concomitant radiotherapy, temozolomide will be administered for an additional six cycles. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m^2/day, and may be increased to 200 mg/m^2/day for Cycle 2 and subsequent cycles depending on nonhematological toxicity observed and neutrophil and platelet count values. Capsules containing 20 mg or 100 mg of temozolomide will be used. Radiotherapy will be administered in combination with temozolomide. Radiotherapy will be administered for a total daily dose of 60 Gy in 30 fractions, 5 days a week for 6 weeks.
1053250|NCT00686712|B4|Baseline|Total|Total of all reporting groups
1053251|NCT00686712|B3|Baseline|NPH Insulin|Bedtime NPH insulin titrated to morning fasting glucose readings
1053252|NCT00686712|B2|Baseline|Insulin Glargine in AM|Morning insulin glargine titrated to pre-supper glucose readings
1053253|NCT00686712|B1|Baseline|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
1053254|NCT00686712|P3|Participant Flow|NPH Insulin|Bedtime NPH insulin titrated to morning fasting glucose readings
1053255|NCT00686712|P2|Participant Flow|Insulin Glargine in AM|Morning insulin glargine titrated to pre-supper glucose readings
1053256|NCT00686712|P1|Participant Flow|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
1053257|NCT00686712|O3|Outcome|3 - NPH Insulin QHS|"NPH insulin injected subcutaneously once daily at bedtime~NPH insulin injected subcutaneously once daily at bedtime: NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses <120 mg/dL)"
1053258|NCT00686712|O2|Outcome|2 - Insulin Glargine QAM|"Insulin glargine injected subcutaneously once daily in the morning~Insulin glargine injected subcutaneously once daily in the morning: Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings <120 mg/dL)"
1053259|NCT00686712|O1|Outcome|1 - Insulin Glargine QHS|"Insulin glargine injected subcutaneously once daily at bedtime~Insulin glargine injected subcutaneously once daily at bedtime: Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings <120 mg/dL)"
1053260|NCT00686712|O3|Outcome|3 - NPH Insulin QHS|"NPH insulin injected subcutaneously once daily at bedtime~NPH insulin injected subcutaneously once daily at bedtime: NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses <120 mg/dL)"
1053261|NCT00686712|O2|Outcome|2 - Insulin Glargine QAM|"Insulin glargine injected subcutaneously once daily in the morning~Insulin glargine injected subcutaneously once daily in the morning: Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings <120 mg/dL)"
1053262|NCT00686712|O1|Outcome|1 - Insulin Glargine QHS|"Insulin glargine injected subcutaneously once daily at bedtime~Insulin glargine injected subcutaneously once daily at bedtime: Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings <120 mg/dL)"
1053263|NCT00686712|O3|Outcome|3 - NPH Insulin QHS|"NPH insulin injected subcutaneously once daily at bedtime~NPH insulin injected subcutaneously once daily at bedtime: NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses <120 mg/dL)"
1053264|NCT00686712|O2|Outcome|2 - Insulin Glargine QAM|"Insulin glargine injected subcutaneously once daily in the morning~Insulin glargine injected subcutaneously once daily in the morning: Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings <120 mg/dL)"
1053265|NCT00686712|O1|Outcome|1 - Insulin Glargine QHS|"Insulin glargine injected subcutaneously once daily at bedtime~Insulin glargine injected subcutaneously once daily at bedtime: Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings <120 mg/dL)"
1053308|NCT00686686|B1|Baseline|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
1053267|NCT00686712|O2|Outcome|2 - Insulin Glargine QAM|"Insulin glargine injected subcutaneously once daily in the morning~Insulin glargine injected subcutaneously once daily in the morning: Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings <120 mg/dL)"
1053268|NCT00686712|O1|Outcome|1 - Insulin Glargine QHS|"Insulin glargine injected subcutaneously once daily at bedtime~Insulin glargine injected subcutaneously once daily at bedtime: Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings <120 mg/dL)"
1053269|NCT00686712|O3|Outcome|3 - NPH Insulin QHS|"NPH insulin injected subcutaneously once daily at bedtime~NPH insulin injected subcutaneously once daily at bedtime: NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses <120 mg/dL)"
1053270|NCT00686712|O2|Outcome|2 - Insulin Glargine QAM|"Insulin glargine injected subcutaneously once daily in the morning~Insulin glargine injected subcutaneously once daily in the morning: Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings <120 mg/dL)"
1053271|NCT00686712|O1|Outcome|1 - Insulin Glargine QHS|"Insulin glargine injected subcutaneously once daily at bedtime~Insulin glargine injected subcutaneously once daily at bedtime: Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings <120 mg/dL)"
1053272|NCT00686712|O3|Outcome|3 - NPH Insulin QHS|"NPH insulin injected subcutaneously once daily at bedtime~NPH insulin injected subcutaneously once daily at bedtime: NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses <120 mg/dL)"
1053273|NCT00686712|O2|Outcome|2 - Insulin Glargine QAM|"Insulin glargine injected subcutaneously once daily in the morning~Insulin glargine injected subcutaneously once daily in the morning: Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings <120 mg/dL)"
1053274|NCT00686712|O1|Outcome|1 - Insulin Glargine QHS|"Insulin glargine injected subcutaneously once daily at bedtime~Insulin glargine injected subcutaneously once daily at bedtime: Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings <120 mg/dL)"
1053275|NCT00686712|O3|Outcome|NPH Insulin|Bedtime NPH insulin titrated to morning fasting glucose readings
1053276|NCT00686712|O2|Outcome|Insulin Glargine in AM|Morning insulin glargine titrated to pre-supper glucose readings
1053277|NCT00686712|O1|Outcome|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
1053278|NCT00686712|E3|Reported Event|NPH Insulin|Bedtime NPH insulin titrated to morning fasting glucose readings
1053279|NCT00686712|E2|Reported Event|Insulin Glargine in AM|Morning insulin glargine titrated to pre-supper glucose readings
1053280|NCT00686712|E1|Reported Event|Insulin Glargine at Bedtime|Bedtime insulin glargine titrated to morning fasting glucose readings
1053281|NCT00686699|B3|Baseline|Total|Total of all reporting groups
1053282|NCT00686699|B2|Baseline|Placebo BID→Preladenant 25 mg BID|Participants received one matching placebo capsule BID for 14 days during the first treatment period and received one preladenant 25 mg capsule during the second treatment period. The 2 treatment periods were separated by a 3-week washout period.
1053283|NCT00686699|B1|Baseline|Preladenant 25 mg BID→Placebo BID|Participants received one preladenant 25 mg capsule BID for 14 days during the first treatment period and received one matching placebo capsule BID during the second treatment period. The 2 treatment periods were separated by a 3-week washout period.
1053284|NCT00686699|P2|Participant Flow|Placebo BID→Preladenant 25 mg BID|Participants received one matching placebo capsule BID for 14 days during the first treatment period and received one preladenant 25 mg capsule during the second treatment period. The 2 treatment periods were separated by a 3-week washout period.
1053285|NCT00686699|P1|Participant Flow|Preladenant 25 mg BID→Placebo BID|Participants received one preladenant 25 mg capsule twice daily (BID) for 14 days during the first treatment period and received one matching placebo capsule BID during the second treatment period. The 2 treatment periods were separated by a 3-week washout period.
1053286|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
1053287|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
1053288|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
1053289|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
1053290|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
1053291|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
1053292|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
1053293|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
1053294|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
1053295|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
1053296|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
1053297|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
1053298|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
1053299|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
1053300|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
1053301|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
1053302|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
1053303|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
1053304|NCT00686699|O2|Outcome|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
1053305|NCT00686699|O1|Outcome|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
1053306|NCT00686699|E2|Reported Event|Placebo BID|Participants received one matching placebo capsule BID for 14 days.
1053307|NCT00686699|E1|Reported Event|Preladenant 25 mg BID|Participants received one preladenant 25 mg capsule BID for 14 days.
1054427|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
1053310|NCT00686686|O1|Outcome|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
1053311|NCT00686686|O1|Outcome|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
1053312|NCT00686686|O1|Outcome|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
1053313|NCT00686686|O1|Outcome|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
1053314|NCT00686686|O1|Outcome|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
1053315|NCT00686686|E1|Reported Event|Infliximab 5 mg/kg|Intravenous infliximab 5 mg/kg given over a 2-hour period at Weeks 0, 2, and 6 and possibly at week 12.
1053316|NCT00686647|B1|Baseline|AngioSculpt Device|
1053317|NCT00686647|P1|Participant Flow|AngioSculpt Device|
1053318|NCT00686647|O1|Outcome|AngioSculpt Device|
1053319|NCT00686647|O1|Outcome|AngioSculpt Device|
1053320|NCT00686647|O1|Outcome|Overall Study|
1053321|NCT00686647|E1|Reported Event|AngioSculpt Device|
1053322|NCT00686634|B1|Baseline|Sitagliptin Treatment|Sitagliptin 100 mg once daily
1053323|NCT00686634|P1|Participant Flow|Sitagliptin Treatment|Sitagliptin 100 mg orally once daily
1053324|NCT00686634|O1|Outcome|Sitagliptin|Any adverse events while receiving sitagliptin
1053325|NCT00686634|O1|Outcome|Sitagliptin|Sitagliptin 100 mg daily
1053326|NCT00686634|O1|Outcome|Sitagliptin|Sitagliptin 100 mg daily
1053327|NCT00686634|O1|Outcome|Sitagliptin|Sitagliptin 100 mg daily
1053328|NCT00686634|E1|Reported Event|Sitagliptin Treatment|Sitagliptin 100 mg once daily
1053329|NCT00686595|B1|Baseline|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
1053330|NCT00686595|P1|Participant Flow|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
1053331|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
1053332|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
1053333|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
1053334|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
1053335|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
1053336|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
1053337|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
1053338|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
1053339|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
1053340|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
1053341|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
1053342|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
1053343|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
1053344|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
1053345|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
1053346|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
1053347|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
1053348|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
1053349|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
1053350|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
1053351|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
1053352|NCT00686595|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
1053353|NCT00686595|E1|Reported Event|Infliximab 5 mg/kg|Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
1053354|NCT00686543|B5|Baseline|Total|Total of all reporting groups
1053383|NCT00686517|P3|Participant Flow|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
1053355|NCT00686543|B4|Baseline|POS 200 mg TID Days 1-8 Followed by POS 400 mg TID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg TID on Days 9-15).
1053356|NCT00686543|B3|Baseline|POS 200 mg TID Days 1-8 Followed by POS 400 mg BID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg BID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg BID on Days 9-15).
1053357|NCT00686543|B2|Baseline|POS 200 mg TID Days 1-8 Followed by POS 200 mg TID Days 9-15|POS 200 mg TID on Days 1-8 Followed by POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to continue with POS 200 mg TID on Days 9-15).
1053358|NCT00686543|B1|Baseline|Not Randomized|POS 200 mg TID on Days 1-8, administered with food or oral nutritional supplements (participants who discontinued anytime before randomization on Day 8).
1053359|NCT00686543|P4|Participant Flow|POS 200 mg TID Days 1-8 Followed by POS 400 mg TID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg TID on Days 9-15).
1053360|NCT00686543|P3|Participant Flow|POS 200 mg TID Days 1-8 Followed by POS 400 mg BID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg Twice a Day (BID) on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg BID on Days 9-15).
1053361|NCT00686543|P2|Participant Flow|POS 200 mg TID Days 1-8 Followed by POS 200 mg TID Days 9-15|POS 200 mg TID on Days 1-8 Followed by POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to continue with POS 200 mg TID on Days 9-15).
1053362|NCT00686543|P1|Participant Flow|Not Randomized|Posaconazole oral suspension (POS) 200 mg Three Times a Day (TID) on Days 1-8, administered with food or oral nutritional supplements (participants who discontinued anytime before randomization on Day 8)
1053363|NCT00686543|O3|Outcome|POS 200 mg TID Days 1-8 Followed by POS 400 mg TID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg TID on Days 9-15).
1053364|NCT00686543|O2|Outcome|POS 200 mg TID Days 1-8 Followed by POS 400 mg BID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg BID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg BID on Days 9-15).
1053365|NCT00686543|O1|Outcome|POS 200 mg TID Days 1-8 Followed by POS 200 mg TID Days 9-15|POS 200 mg TID on Days 1-8 Followed by POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to continue with POS 200 mg TID on Days 9-15).
1053366|NCT00686543|O3|Outcome|POS 200 mg TID Days 1-8 Followed by POS 400 mg TID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg TID on Days 9-15).
1053367|NCT00686543|O2|Outcome|POS 200 mg TID Days 1-8 Followed by POS 400 mg BID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg BID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg BID on Days 9-15).
1053368|NCT00686543|O1|Outcome|POS 200 mg TID Days 1-8 Followed by POS 200 mg TID Days 9-15|POS 200 mg TID on Days 1-8 Followed by POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to continue with POS 200 mg TID on Days 9-15).
1053369|NCT00686543|O1|Outcome|POS 200 mg TID Days 1-8|POS 200 mg TID on Days 1-8, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to one of the three dosing regimens for Days 9-15).
1053370|NCT00686543|O1|Outcome|POS 200 mg TID Days 1-8|POS 200 mg TID on Days 1-8, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to one of the three dosing regimens for Days 9-15).
1053371|NCT00686543|O3|Outcome|POS 200 mg TID Days 1-8 Followed by POS 400 mg TID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg TID on Days 9-15).
1053372|NCT00686543|O2|Outcome|POS 200 mg TID Days 1-8 Followed by POS 400 mg BID Days 9-15|POS 200 mg TID on Days 1-8 followed by POS 400 mg BID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg BID on Days 9-15).
1053373|NCT00686543|O1|Outcome|POS 200 mg TID Days 1-8 Followed by POS 200 mg TID Days 9-15|POS 200 mg TID on Days 1-8 Followed by POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to continue with POS 200 mg TID on Days 9-15).
1053374|NCT00686543|O1|Outcome|POS 200 mg TID Days 1-8|POS 200 mg TID on Days 1-8, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to one of the three dosing regimens for Days 9-15).
1053375|NCT00686543|E4|Reported Event|POS 400 mg TID on Days 9-15|POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements.
1053376|NCT00686543|E3|Reported Event|POS 400 mg BID on Days 9-15|POS 400 mg on Days 9-15, administered with food or oral nutritional supplements.
1053377|NCT00686543|E2|Reported Event|POS 200 mg TID on Days 9-15|POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements.
1053378|NCT00686543|E1|Reported Event|POS 200 mg TID on Days 1-8|POS 200 mg TID on Days 1-8, administered with food or oral nutritional supplements.
1053379|NCT00686517|B4|Baseline|Total|Total of all reporting groups
1053380|NCT00686517|B3|Baseline|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
1053381|NCT00686517|B2|Baseline|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
1053382|NCT00686517|B1|Baseline|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
1053384|NCT00686517|P2|Participant Flow|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
1053385|NCT00686517|P1|Participant Flow|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
1053386|NCT00686517|O3|Outcome|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
1053387|NCT00686517|O2|Outcome|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
1053388|NCT00686517|O1|Outcome|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
1053389|NCT00686517|O3|Outcome|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
1053390|NCT00686517|O2|Outcome|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
1053391|NCT00686517|O1|Outcome|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
1053392|NCT00686517|O3|Outcome|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
1053393|NCT00686517|O2|Outcome|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
1053394|NCT00686517|O1|Outcome|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
1053395|NCT00686517|O3|Outcome|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
1053396|NCT00686517|O2|Outcome|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
1053397|NCT00686517|O1|Outcome|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
1053398|NCT00686517|O3|Outcome|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
1053399|NCT00686517|O2|Outcome|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
1053400|NCT00686517|O1|Outcome|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
1053401|NCT00686517|O3|Outcome|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
1053402|NCT00686517|O2|Outcome|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
1053403|NCT00686517|O1|Outcome|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
1053404|NCT00686517|E3|Reported Event|PEG-IFN + RVB 12|Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
1053405|NCT00686517|E2|Reported Event|PEG-IFN 24|Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
1053406|NCT00686517|E1|Reported Event|PEG-IFN 12|Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
1053407|NCT00686335|B1|Baseline|Safety Population|all patients that started the run-in period with Cortancyl®
1053408|NCT00686335|P1|Participant Flow|Safety Population|all patients that started the run-in period with Cortancyl®
1053409|NCT00686335|O2|Outcome|Cortancyl|immediate release prednisone
1053410|NCT00686335|O1|Outcome|Lodotra|modified release prednisone
1053411|NCT00686335|E2|Reported Event|Cortancyl|immediate release prednisone
1053412|NCT00686335|E1|Reported Event|Lodotra|modified release prednisone
1053413|NCT00686257|B3|Baseline|Total|Total of all reporting groups
1053414|NCT00686257|B2|Baseline|Standard Face Mask Controls|Patients receiving NPPV by 'standard oronasal mask'
1053415|NCT00686257|B1|Baseline|Total Face Mask|Patients receiving NPPV by the 'Total Face Mask' or standard face mask controls
1053416|NCT00686257|P2|Participant Flow|Standard Face Mask Controls|Patients receiving NPPV by 'standard oronasal mask'
1053417|NCT00686257|P1|Participant Flow|Total Face Mask|Patients receiving NPPV by the 'Total Face Mask' or standard face mask controls
1053418|NCT00686257|O2|Outcome|Total Face Mask|Received Total Face Mask
1053419|NCT00686257|O1|Outcome|Control|Received standard face mask
1053420|NCT00686257|E2|Reported Event|Standard Face Mask Controls|Patients receiving NPPV by 'standard oronasal mask'
1053421|NCT00686257|E1|Reported Event|Total Face Mask|Patients receiving NPPV by the 'Total Face Mask' or standard face mask controls
1053422|NCT00686231|B4|Baseline|Total|Total of all reporting groups
1053423|NCT00686231|B3|Baseline|Nitro|1 inch / 2 inches of Nitroglycerin applied topically to the wrist
1053424|NCT00686231|B2|Baseline|Lidocaine|Lidocaine 1 inch
1053425|NCT00686231|B1|Baseline|Placebo|Sorbolene cream
1053426|NCT00686231|P3|Participant Flow|Nitro|1 inch / 2 inches of Nitroglycerin applied topically to the wrist
1053427|NCT00686231|P2|Participant Flow|Lidocaine|Lidocaine 1 inch
1053428|NCT00686231|P1|Participant Flow|Placebo|Sorbolene cream
1053429|NCT00686231|O3|Outcome|Nitro|1 inch / 2 inches of Nitroglycerin applied topically to the wrist
1053430|NCT00686231|O2|Outcome|Lidocaine|Lidocaine 1 inch
1053431|NCT00686231|O1|Outcome|Placebo|Sorbolene cream
1053432|NCT00686231|E3|Reported Event|Nitro|1 inch / 2 inches of Nitroglycerin applied topically to the wrist
1053433|NCT00686231|E2|Reported Event|Lidocaine|Lidocaine 1 inch
1053434|NCT00686231|E1|Reported Event|Placebo|Sorbolene cream
1053435|NCT00686205|B3|Baseline|Total|Total of all reporting groups
1053436|NCT00686205|B2|Baseline|ABBOTT PRISM® HIV O Plus Assay Results for Sensitivity|Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay.
1053437|NCT00686205|B1|Baseline|ABBOTT PRISM® HIV O Plus Assay Results for Specificity|Blood specimens collected from donors were tested by the investigational HIV test.
1053438|NCT00686205|P2|Participant Flow|ABBOTT PRISM® HIV O Plus Assay Results for Sensitivity|Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay.
1053439|NCT00686205|P1|Participant Flow|ABBOTT PRISM® HIV O Plus Assay Results for Specificity|Blood specimens collected from donors were tested by the investigational HIV test.
1053440|NCT00686205|O1|Outcome|HIV Positive Samples|Known HIV-1 or HIV-2 positive samples were used. Samples were determined to be positive by HIV-1 or HIV-2 western blot.
1053441|NCT00686205|O1|Outcome|HIV Negative Donors|Donors with HIV-1/2 negative results using reference test and negative by HIV-1 RNA test
1053442|NCT00686205|E2|Reported Event|ABBOTT PRISM® HIV O Plus Assay Results for Sensitivity|Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay.
1053443|NCT00686205|E1|Reported Event|ABBOTT PRISM® HIV O Plus Assay Results for Specificity|Blood specimens collected from donors were tested by the investigational HIV test.
1053444|NCT00685880|B3|Baseline|Total|Total of all reporting groups
1053445|NCT00685880|B2|Baseline|Corticosteroid Group|Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
1053446|NCT00685880|B1|Baseline|Prolotherapy Group|Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint.
1053447|NCT00685880|P2|Participant Flow|Corticosteroid Group|Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
1053448|NCT00685880|P1|Participant Flow|Prolotherapy Group|Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint.
1053449|NCT00685880|O2|Outcome|Corticosteroid Group|Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
1053450|NCT00685880|O1|Outcome|Prolotherapy Group|Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint.
1053451|NCT00685880|E2|Reported Event|Corticosteroid Group|Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
1053452|NCT00685880|E1|Reported Event|Prolotherapy Group|Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint.
1053453|NCT00685802|B1|Baseline|Cilostazol 50 mg Tablets and Pletal® 50 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received two tablets of either Cilostazol 50 mg or Pletal® 50 mg following an overnight fast of at least 10 hours.
1053454|NCT00685802|P2|Participant Flow|Pletal® 50 mg Tablets Then Cilostazol 50 mg Tablets|On the morning of Day 1 subjects received two tablets of the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received two tablets of the test formulation, Cilostazol 50 mg, after an overnight fast of at least 10 hours.
1053455|NCT00685802|P1|Participant Flow|Cilostazol 50 mg Tablets Then Pletal® 50 mg Tablets|On the morning of Day 1 subjects received two tablets of the test formulation, Cilostazol 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received two tablets of the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours.
1053456|NCT00685802|O2|Outcome|Pletal® 50 mg Tablets|On the morning of Day 1 subjects received two tablets of either the test formulation, cilostazol 50mg, or the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
1053457|NCT00685802|O1|Outcome|Cilostazol 50 mg Tablets|On the morning of Day 1 subjects received two tablets of either the test formulation, cilostazol 50mg, or the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
1053458|NCT00685802|O2|Outcome|Pletal® 50 mg Tablets|On the morning of Day 1 subjects received two tablets of either the test formulation, cilostazol 50mg, or the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
1053459|NCT00685802|O1|Outcome|Cilostazol 50 mg Tablets|On the morning of Day 1 subjects received two tablets of either the test formulation, cilostazol 50mg, or the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
1053460|NCT00685802|O2|Outcome|Pletal® 50 mg Tablets|On the morning of Day 1 subjects received two tablets of either the test formulation, cilostazol 50mg, or the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
1053461|NCT00685802|O1|Outcome|Cilostazol 50 mg Tablets|On the morning of Day 1 subjects received two tablets of either the test formulation, cilostazol 50mg, or the reference formulation, Pletal® 50 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
1053462|NCT00685802|E2|Reported Event|Pletal® 50 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received two tablets of either cilostazol 50 mg or Pletal® 50 mg following an overnight fast of at least 10 hours.
1053463|NCT00685802|E1|Reported Event|Cilostazol 50 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received two tablets of either cilostazol 50 mg or Pletal® 50 mg following an overnight fast of at least 10 hours.
1053464|NCT00685763|B1|Baseline|Proton Radiation and Chemotherapy|Unresectable Carcinoma of the Pancreas
1053465|NCT00685763|P1|Participant Flow|Proton Radiation and Chemotherapy|"Chemotherapy and Radiation Combination~Proton radiation 59.4 cobalt gray equivalent(CGE) in 33 fx at 1.8 CGE per fx over 7 weeks.~Capecitabine (Xeloda ®) 1,000 mg by mouth approximately every 12 hrs, 5 days/week starting the first day of radiation until the end of radiation, but on radiation days only.~Consolidation Chemotherapy starting 4 weeks after the completion of radiation~Gemcitabine (Gemzar ®) Suggested Regimen - 1,000mg/m2 by IV over 30 minutes once a week for 3 weeks (followed by a week of rest) for 12 total doses.~Proton radiation and chemotherapy: Chemotherapy Capecitabine (Xeloda ®) 1,000 mg by mouth twice a day, 5 days/week (M-F)~Proton radiation 59.4 CGE in 33 fx at 1.8 CGE per fx over 7 weeks .~Consolidation Chemotherapy: Suggested Regimen - Gemcitabine total of 12 doses"
1053498|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053499|NCT00685698|O2|Outcome|Nemonoxacin (PP Population at Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053500|NCT00685698|O1|Outcome|Nemonoxacin (ITT Population at Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053466|NCT00685763|O1|Outcome|Proton Radiation and Chemotherapy|"Chemotherapy and Radiation Combination~Proton radiation 59.4 cobalt gray equivalent(CGE) in 33 fx at 1.8 CGE per fx over 7 weeks.~Capecitabine (Xeloda ®) 1,000 mg by mouth approximately every 12 hrs, 5 days/week starting the first day of radiation until the end of radiation, but on radiation days only.~Consolidation Chemotherapy starting 4 weeks after the completion of radiation~Gemcitabine (Gemzar ®) Suggested Regimen - 1,000mg/m2 by IV over 30 minutes once a week for 3 weeks (followed by a week of rest) for 12 total doses.~Proton radiation and chemotherapy: Chemotherapy Capecitabine (Xeloda ®) 1,000 mg by mouth twice a day, 5 days/week (M-F)~Proton radiation 59.4 CGE in 33 fx at 1.8 CGE per fx over 7 weeks .~Consolidation Chemotherapy: Suggested Regimen - Gemcitabine total of 12 doses"
1053467|NCT00685763|E1|Reported Event|Proton Radiation and Chemotherapy|"Chemotherapy and Radiation Combination~Proton radiation 59.4 cobalt gray equivalent(CGE) in 33 fx at 1.8 CGE per fx over 7 weeks.~Capecitabine (Xeloda ®) 1,000 mg by mouth approximately every 12 hrs, 5 days/week starting the first day of radiation until the end of radiation, but on radiation days only.~Consolidation Chemotherapy starting 4 weeks after the completion of radiation~Gemcitabine (Gemzar ®) Suggested Regimen - 1,000mg/m2 by IV over 30 minutes once a week for 3 weeks (followed by a week of rest) for 12 total doses.~Proton radiation and chemotherapy: Chemotherapy Capecitabine (Xeloda ®) 1,000 mg by mouth twice a day, 5 days/week (M-F)~Proton radiation 59.4 CGE in 33 fx at 1.8 CGE per fx over 7 weeks .~Consolidation Chemotherapy: Suggested Regimen - Gemcitabine total of 12 doses"
1053468|NCT00685698|B1|Baseline|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053469|NCT00685698|P1|Participant Flow|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053470|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053471|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053472|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053473|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053474|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053475|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053476|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053477|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053478|NCT00685698|O3|Outcome|Nemonoxacin (Change From Baseline to EOT/ET Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053479|NCT00685698|O2|Outcome|Nemonoxacin (at EOT/ET Visit, PP Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053480|NCT00685698|O1|Outcome|Nemonoxacin (at Baseline, PP Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053481|NCT00685698|O3|Outcome|Nemonoxacin (Change From Baseline to EOT/ET Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053482|NCT00685698|O2|Outcome|Nemonoxacin (at EOT/ET Visit, ITT Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053483|NCT00685698|O1|Outcome|Nemonoxacin (at Baseline, ITT Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053484|NCT00685698|O3|Outcome|Nemonoxacin (Change From Baseline to Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053485|NCT00685698|O2|Outcome|Nemonoxacin (at Test of Cure Visit, PP Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053486|NCT00685698|O1|Outcome|Nemonoxacin (at Baseline, PP Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053487|NCT00685698|O3|Outcome|Nemonoxacin (Change From Baseline to Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053488|NCT00685698|O2|Outcome|Nemonoxacin (at Test of Cure Visit, ITT Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053489|NCT00685698|O1|Outcome|Nemonoxacin (at Baseline, ITT Population)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053490|NCT00685698|O2|Outcome|Nemonoxacin (PP Population at Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053491|NCT00685698|O1|Outcome|Nemonoxacin (ITT Population at Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053492|NCT00685698|O2|Outcome|Nemonoxacin (PP Population at EOT/ET)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053493|NCT00685698|O1|Outcome|Nemonoxacin (ITT Population at EOT/ET)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053494|NCT00685698|O2|Outcome|Nemonoxacin (PP Population at Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053495|NCT00685698|O1|Outcome|Nemonoxacin (ITT Population at Test of Cure Visit)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053496|NCT00685698|O2|Outcome|Nemonoxacin (PP Population at EOT/ET)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053497|NCT00685698|O1|Outcome|Nemonoxacin (ITT Population at EOT/ET)|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053501|NCT00685698|O1|Outcome|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053502|NCT00685698|E1|Reported Event|Nemonoxacin|"Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days.~TG-873870 (Nemonoxacin): 750 mg"
1053503|NCT00685685|B1|Baseline|Lovastatin 40 mg Tablets and Mevacor® 40 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg following an overnight fast of at least 10 hours.
1053504|NCT00685685|P2|Participant Flow|Mevacor® 40 mg Tablets Then Lovastatin 40 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference formulation, Mevacor® 40 mg after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, Lovastatin 40 mg, after an overnight fast of at least 10 hours.
1053505|NCT00685685|P1|Participant Flow|Lovastatin 40 mg Tablets Then Mevacor® 40 mg Tablets|On the morning of Day 1 subjects received one tablet of the test formulation, Lovastatin 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours.
1053506|NCT00685685|O2|Outcome|Mevacor® 40 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
1053507|NCT00685685|O1|Outcome|Lovastatin 40 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
1053508|NCT00685685|O2|Outcome|Mevacor® 40 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
1053509|NCT00685685|O1|Outcome|Lovastatin 40 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
1053510|NCT00685685|O2|Outcome|Mevacor® 40 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
1053511|NCT00685685|O1|Outcome|Lovastatin 40 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
1053512|NCT00685685|E2|Reported Event|Mevacor® 40 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg following an overnight fast of at least 10 hours.
1053513|NCT00685685|E1|Reported Event|Lovastatin 40 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg following an overnight fast of at least 10 hours.
1053514|NCT00685659|B4|Baseline|Total|Total of all reporting groups
1053515|NCT00685659|B3|Baseline|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
1053516|NCT00685659|B2|Baseline|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
1053517|NCT00685659|B1|Baseline|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
1053518|NCT00685659|P3|Participant Flow|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
1053519|NCT00685659|P2|Participant Flow|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
1053520|NCT00685659|P1|Participant Flow|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
1053521|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
1053522|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
1054428|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
1053523|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
1053524|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
1053525|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
1053526|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
1053527|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
1053528|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
1053529|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
1053530|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
1053531|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
1053532|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
1053533|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
1053534|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
1053535|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
1053536|NCT00685659|O3|Outcome|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
1053537|NCT00685659|O2|Outcome|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
1053538|NCT00685659|O1|Outcome|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
1053539|NCT00685659|E3|Reported Event|TMAC Plus|"Adaptive telephone-based counseling, plus incentives~Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included"
1053540|NCT00685659|E2|Reported Event|TMAC|"Adaptive telephone-based counseling~Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included"
1053541|NCT00685659|E1|Reported Event|Treatment as Usual|"Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)~Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months"
1053542|NCT00685516|B4|Baseline|Total|Total of all reporting groups
1053543|NCT00685516|B3|Baseline|Arm III - Decaffeinated Black Tea|"Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.~decaffeinated black tea: 6 cups of decaffeinated black tea daily for 2-8 weeks"
1053544|NCT00685516|B2|Baseline|Arm II - Water|"Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: 6 cups of water daily for 2-8 weeks"
1053545|NCT00685516|B1|Baseline|Arm I - Green Tea|"Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.~green tea: 6 cups of green tea daily for 2-8 weeks"
1053546|NCT00685516|P3|Participant Flow|Arm III - Decaffeinated Black Tea|"Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.~decaffeinated black tea: 6 cups of decaffeinated black tea daily for 2-8 weeks"
1053547|NCT00685516|P2|Participant Flow|Arm II - Water|"Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: 6 cups of water daily for 2-8 weeks"
1054429|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
1053548|NCT00685516|P1|Participant Flow|Arm I - Green Tea|"Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.~green tea: 6 cups of green tea daily for 2-8 weeks"
1053549|NCT00685516|O3|Outcome|Arm III - Decaffeinated Black Tea|"Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.~decaffeinated black tea: 6 cups of decaffeinated black tea daily for 2-8 weeks"
1053550|NCT00685516|O2|Outcome|Arm II - Water|"Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: 6 cups of water daily for 2-8 weeks"
1053551|NCT00685516|O1|Outcome|Arm I - Green Tea|"Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.~green tea: 6 cups of green tea daily for 2-8 weeks"
1053552|NCT00685516|O3|Outcome|Arm III - Decaffeinated Black Tea|"Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.~decaffeinated black tea: 6 cups of decaffeinated black tea daily for 2-8 weeks"
1053553|NCT00685516|O2|Outcome|Arm II - Water|"Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: 6 cups of water daily for 2-8 weeks"
1053554|NCT00685516|O1|Outcome|Arm I - Green Tea|"Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.~green tea: 6 cups of green tea daily for 2-8 weeks"
1053555|NCT00685516|O3|Outcome|Arm III - Decaffeinated Black Tea|"Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.~decaffeinated black tea: 6 cups of decaffeinated black tea daily for 2-8 weeks"
1053556|NCT00685516|O2|Outcome|Arm II - Water|"Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: 6 cups of water daily for 2-8 weeks"
1053557|NCT00685516|O1|Outcome|Arm I - Green Tea|"Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.~green tea: 6 cups of green tea daily for 2-8 weeks"
1053558|NCT00685516|O3|Outcome|Arm III - Decaffeinated Black Tea|Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.
1053559|NCT00685516|O2|Outcome|Arm II - Water|Placebo:patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.
1053560|NCT00685516|O1|Outcome|Arm I - Green Tea|Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.
1053561|NCT00685516|E3|Reported Event|Arm III - Decaffeinated Black Tea|"Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.~decaffeinated black tea: 6 cups of decaffeinated black tea daily for 2-8 weeks"
1053562|NCT00685516|E2|Reported Event|Arm II - Water|"Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: 6 cups of water daily for 2-8 weeks"
1053563|NCT00685516|E1|Reported Event|Arm I - Green Tea|"Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.~green tea: 6 cups of green tea daily for 2-8 weeks"
1053564|NCT00685477|B1|Baseline|All Study Participants|CCK-8 0.02 mg/kg over 15, 30 or 60 minutes: Drug will be given over infusions at different time periods. All participants received all treatments.
1053565|NCT00685477|P6|Participant Flow|Experimental Sequence CBA|Drug given over 60 minutes infusion followed by infusion over 30 minutes, followed by infusion over 15 minutes
1053566|NCT00685477|P5|Participant Flow|Experimental Sequence CAB|Drug given over 60 minutes infusion followed by infusion over 15 minutes, followed by infusion over 30 minutes
1053567|NCT00685477|P4|Participant Flow|Experimental Sequence BCA|Drug given over 30 minutes infusion followed by infusion over 60 minutes, followed by infusion over 15 minutes
1053568|NCT00685477|P3|Participant Flow|Experimental Sequence BAC|Drug given over 30 minutes infusion followed by infusion over 15 minutes, followed by infusion over 60 minutes
1053569|NCT00685477|P2|Participant Flow|Experimental Sequence ACB|Drug given over 15 minutes infusion followed by infusion over 60 minutes, followed by infusion over 30 minutes
1053570|NCT00685477|P1|Participant Flow|Experimental Sequence ABC|Drug given over 15 minutes infusion followed by infusion over 30 minutes, followed by infusion over 60 minutes
1053571|NCT00685477|O3|Outcome|60 Minute Infusion|Drug given over 60 minutes
1053572|NCT00685477|O2|Outcome|30 Minute Infusion|Drug given over 30 minutes
1053573|NCT00685477|O1|Outcome|15 Minute Infusion|Drug given over 15 minutes
1053574|NCT00685477|O3|Outcome|60 Min Infusion|Drug given over 60 minutes infusion
1053575|NCT00685477|O2|Outcome|30 Min Infusion|Drug given over 30 minutes infusion
1053576|NCT00685477|O1|Outcome|15min Infusion|Drug given over 15 minutes infusion
1053577|NCT00685477|E1|Reported Event|All Study Participants|Drug given over 15 minute infusion to look at lowest coefficient of variation in infusion, followed by infusion over 30 minutes, followed by infusion over 60 minutes
1053578|NCT00685373|B1|Baseline|Canakinumab (ACZ885)|Subcutaneous injection every 8 weeks based on participant's body weight. Body weight >40 kilogram (kg): 150 milligrams (mg) per injection and body weight <= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent doses were permitted as per protocol.
1053579|NCT00685373|P1|Participant Flow|Canakinumab (ACZ885)|Subcutaneous injection every 8 weeks based on participant's body weight. Body weight >40 kilogram (kg): 150 milligrams (mg) per injection and body weight <= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent doses were permitted as per protocol.
1053580|NCT00685373|O1|Outcome|Canakinumab (ACZ885)|Subcutaneous injection every 8 weeks based on participant's body weight. Body weight >40 kilogram (kg): 150 milligrams (mg) per injection and body weight <= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent doses were permitted as per protocol.
1053581|NCT00685373|O1|Outcome|Canakinumab (ACZ885)|Subcutaneous injection every 8 weeks based on participant's body weight. Body weight >40 kilogram (kg): 150 milligrams (mg) per injection and body weight <= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent doses were permitted as per protocol.
1053659|NCT00684996|O2|Outcome|Phase II Arm II|Patients receive bevacizumab IV as in arm I at the RPTD determined in phase I, and humanized monoclonal antibody MEDI-522 (8mg/kg) IV over 30 minutes on days 1, 8, 15, and 22.
1053582|NCT00685373|O1|Outcome|Canakinumab (ACZ885)|Subcutaneous injection every 8 weeks based on participant's body weight. Body weight >40 kilogram (kg): 150 milligrams (mg) per injection and body weight <= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent doses were permitted as per protocol.
1053583|NCT00685373|O1|Outcome|Canakinumab (ACZ885)|Subcutaneous injection every 8 weeks based on participant's body weight. Body weight >40 kilogram (kg): 150 milligrams (mg) per injection and body weight <= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent doses were permitted as per protocol.
1053584|NCT00685373|E1|Reported Event|Canakinumab (ACZ885)|Subcutaneous injection every 8 weeks based on participant's body weight. Body weight >40 kilogram (kg): 150 milligrams (mg) per injection and body weight <= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent doses were permitted as per protocol.
1053585|NCT00685334|B3|Baseline|Total|Total of all reporting groups
1053586|NCT00685334|B2|Baseline|Aripiprazole|Aripiprazole dosing will begin at 5 mg daily, and will be increased every two weeks, first to 10 mg daily, then 15 mg daily for the final 8 weeks of the trial, unless lower doses are necessary.
1053587|NCT00685334|B1|Baseline|Olanzapine|Dosing of Olanzapine will begin at 2.5 mg and be increased every 2 weeks, first to 5 mg and then 10 mg, if the patient is tolerating the medication. Patients will remain on 10 mg for the final 8 weeks of the trial unless lower doses are necessary.
1053588|NCT00685334|P2|Participant Flow|Aripiprazole|Aripiprazole dosing will begin at 5 mg daily, and will be increased every two weeks, first to 10 mg daily, then 15 mg daily for the final 8 weeks of the trial, unless lower doses are necessary.
1053589|NCT00685334|P1|Participant Flow|Olanzapine|Dosing of Olanzapine will begin at 2.5 mg and be increased every 2 weeks, first to 5 mg and then 10 mg, if the patient is tolerating the medication. Patients will remain on 10 mg for the final 8 weeks of the trial unless lower doses are necessary.
1053590|NCT00685334|O2|Outcome|Aripiprazole|Aripiprazole dosing will begin at 5 mg daily, and will be increased every two weeks, first to 10 mg daily, then 15 mg daily for the final 8 weeks of the trial, unless lower doses are necessary.
1053591|NCT00685334|O1|Outcome|Olanzapine|Dosing of Olanzapine will begin at 2.5 mg and be increased every 2 weeks, first to 5 mg and then 10 mg, if the patient is tolerating the medication. Patients will remain on 10 mg for the final 8 weeks of the trial unless lower doses are necessary.
1053592|NCT00685334|O2|Outcome|Aripiprazole|Aripiprazole dosing will begin at 5 mg daily, and will be increased every two weeks, first to 10 mg daily, then 15 mg daily for the final 8 weeks of the trial, unless lower doses are necessary.
1053593|NCT00685334|O1|Outcome|Olanzapine|Dosing of Olanzapine will begin at 2.5 mg and be increased every 2 weeks, first to 5 mg and then 10 mg, if the patient is tolerating the medication. Patients will remain on 10 mg for the final 8 weeks of the trial unless lower doses are necessary.
1053594|NCT00685334|E2|Reported Event|Aripiprazole|Aripiprazole dosing will begin at 5 mg daily, and will be increased every two weeks, first to 10 mg daily, then 15 mg daily for the final 8 weeks of the trial, unless lower doses are necessary.
1053595|NCT00685334|E1|Reported Event|Olanzapine|Dosing of Olanzapine will begin at 2.5 mg and be increased every 2 weeks, first to 5 mg and then 10 mg, if the patient is tolerating the medication. Patients will remain on 10 mg for the final 8 weeks of the trial unless lower doses are necessary.
1053596|NCT00685295|B3|Baseline|Total|Total of all reporting groups
1053597|NCT00685295|B2|Baseline|Arm 2 / Percocet/Prevacid|Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet
1053598|NCT00685295|B1|Baseline|Arm 1 / Fentora|Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet
1053599|NCT00685295|P2|Participant Flow|Arm 2 / Percocet/Prevacid|Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet
1053600|NCT00685295|P1|Participant Flow|Arm 1 / Fentora|Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet
1053601|NCT00685295|O2|Outcome|Arm 2 / Percocet/Prevacid|"Active Comparator Group:~Subject receives:~Oxycodone/APAP (Percocet) 5/325 mg oral/swallowed pill~Lansoprazole 15 mg (Prevacid) comparator rapidly dissolving transbuccal tablet~Lansoprazole: lansoprazole 15mg rapidly dissolving tablet~Oxycodone: Oxycodone 5/325 mg tablet"
1053602|NCT00685295|O1|Outcome|Arm 1 / Fentora|"Intervention Group:~Subject receives:~placebo oral/swallowed pill~Fentanyl (Fentora) 100mcg rapidly dissolving transbuccal tablet~Fentanyl: Fentanyl rapid dissolving tablet 100mcg"
1053603|NCT00685295|O2|Outcome|Arm 2 / Percocet/Prevacid|Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet
1053604|NCT00685295|O1|Outcome|Arm 1 / Fentora|Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet
1053605|NCT00685295|O2|Outcome|Arm 2 / Percocet/Prevacid|Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet
1053606|NCT00685295|O1|Outcome|Arm 1 / Fentora|Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet
1053607|NCT00685295|E2|Reported Event|Arm 2 / Percocet/Prevacid|Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet
1053608|NCT00685295|E1|Reported Event|Arm 1 / Fentora|Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet
1053609|NCT00685165|B1|Baseline|Primidone 50 mg Tablets and Mysoline® 50 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one tablet of either primidone 50 mg or Mysoline® 50 mg following an overnight fast of at least 10 hours.
1053610|NCT00685165|P2|Participant Flow|Mysoline® 50 mg Tablets Then Primidone 50 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference formulation, Mysoline® 50 mg, after an overnight fast of at least 10 hours, followed by a 14 day washout period. On the morning of Day 15 subjects received one tablet of the test formulation, Primidone 50 mg, after an overnight fast of at least 10 hours.
1053660|NCT00684996|O1|Outcome|Phase II Arm I|Patients receive bevacizumab (10mg/kg) IV over 30-90 minutes on days 1 and 15.
1053742|NCT00684671|O2|Outcome|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
1053611|NCT00685165|P1|Participant Flow|Primidone 50 mg Tablets Then Mysoline® 50 mg Tablets|On the morning of Day 1 subjects received one tablet of the test formulation, primidone 50 mg, after an overnight fast of at least 10 hours, followed by a 14 day washout period. On the morning of Day 15 subjects received one tablet of the reference formulation, Mysoline® 50 mg, after an overnight fast of at least 10 hours.
1053612|NCT00685165|O2|Outcome|Mysoline® 50 mg Tablets|Each subject received one tablet of Mysoline® 50 mg after an overnight fast of at least 10 hours.
1053613|NCT00685165|O1|Outcome|Primidone 50 mg Tablets|Each subject received one tablet of primidone 50 mg after an overnight fast of at least 10 hours.
1053614|NCT00685165|O2|Outcome|Mysoline® 50 mg Tablets|Each subject received one tablet of Mysoline® 50 mg after an overnight fast of at least 10 hours.
1053615|NCT00685165|O1|Outcome|Primidone 50 mg Tablets|Each subject received one tablet of primidone 50 mg after an overnight fast of at least 10 hours.
1053616|NCT00685165|O2|Outcome|Mysoline® 50 mg Tablets|Each subject received one tablet of Mysoline® 50 mg after an overnight fast of at least 10 hours.
1053617|NCT00685165|O1|Outcome|Primidone 50 mg Tablets|Each subject received one tablet of primidone 50 mg after an overnight fast of at least 10 hours.
1053618|NCT00685165|E2|Reported Event|Mysoline® 50 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one tablet of either primidone 50 mg or Mysoline® 50 mg following an overnight fast.
1053619|NCT00685165|E1|Reported Event|Primidone 50 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one tablet of either primidone 50 mg or Mysoline® 50 mg following an overnight fast.
1053620|NCT00685139|B1|Baseline|Zonisamide 100 mg Capsules and Zonegran® 100 mg Capsules|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 29, each subject received one capsule of either zonisamide 100 mg or Zonegran® 100 mg following an overnight fast.
1053621|NCT00685139|P2|Participant Flow|Zonegran® 100 mg Capsules Then Zonisamide 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the reference formulation, Zonegran® 100 mg, after an overnight fast, followed by a 28 day washout period. On the morning of Day 29 subjects received one capsule of the test formulation, zonisamide 100 mg, after an overnight fast.
1053622|NCT00685139|P1|Participant Flow|Zonisamide 100 mg Capsules Then Zonegran® 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, after an overnight fast, followed by a 28 day washout period. On the morning of Day 29 subjects received one capsule of the reference formulation, Zonegran® 100 mg, after an overnight fast.
1053623|NCT00685139|O2|Outcome|Zonegran® 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, after an overnight fast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen following an overnight fast.
1053624|NCT00685139|O1|Outcome|Zonisamide 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, after an overnight fast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen following an overnight fast.
1053625|NCT00685139|O2|Outcome|Zonegran® 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, after an overnight fast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen following an overnight fast.
1053626|NCT00685139|O1|Outcome|Zonisamide 100 mg Capsules|On the morning of Day 1 subjects received one capsule of the test formulation, zonisamide 100 mg, or the reference formulation, Zonegran® 100 mg, after an overnight fast followed by a 28 day washout period. On the morning of Day 29 subjects received the alternate regimen following an overnight fast.
1053627|NCT00685139|E2|Reported Event|Zonegran® 100 mg Capsules|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 29, each subject received one capsule of either zonisamide 100 mg or Zonegran® 100 mg following an overnight fast.
1053628|NCT00685139|E1|Reported Event|Zonisamide 100 mg Capsules|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 29, each subject received one capsule of either zonisamide 100 mg or Zonegran 100 mg following an overnight fast.
1053629|NCT00685035|B1|Baseline|All Study Participants|"Half patients randomly assigned to HFCWC therapy first with a higher-pressure/variable frequency protocol. This entailed performing a 30 minute session with pressure of 10 and 5 minutes each at frequencies of 8,9, and 10 Hz followed by pressure of 6 and 5 minutes each at frequencies of 18, 19, and 20 Hz. This group subsequently crossed-over to the lower-pressure/mid-frequency HFCWC protocol after a washout period of 2 days. This entailed performing a HFCWC session using a pressure of 5 and frequency of 12 Hz for the entire 30 minute session. The other half of subjects were randomly assigned to perform the lower-pressure/mid-frequency protocol first followed by the higher pressure/mixed-frequency after the 2 day washout period~VEST Airway Clearance System, Model 205 : Subjects will perform pulmonary function tests prior to and following each airway clearance therapy. All sputum produced during, and for 15 minutes following airway clearance therapy will be collected. Subjects"
1053630|NCT00685035|P2|Participant Flow|Lower Pressure/Mid-freq, Then Higher Pressure/Variable-freq|HFCWC therapy first with a lower pressure/mid-frequency protocol (1st Intervention). After a washout period of 2 days, this group subsequently crossed-over to the higher-pressure/variable frequency HFCWC protocol (2nd Intervention).
1053631|NCT00685035|P1|Participant Flow|Higher Pressure/Variable-freq, Then Lower Pressure/Mid-freq|HFCWC therapy first with a higher pressure/variable frequency protocol (1st Intervention). After a washout period of 2 days, this group subsequently crossed-over to the lower-pressure/mid-frequency HFCWC protocol (2nd Intervention).
1053632|NCT00685035|O4|Outcome|Perceived Effectiveness Lower Pressure/Mid-frequency|"Following each HFCWC session on day 1 and day 4, subjects completed a questionnaire that rated the comfort and efficacy of each HFCWC session using a 5-point scale. The questionnaire was entitled Post-Therapy Questionnaire. Scale range for how effective the HFCWC session was ranged from 1 (minimally effective) to 3 (neutral) to 5 (very effective)."
1053946|NCT00684255|B1|Baseline|Systemic Sclerosis (SSc)|Reduced Intensity Regimen Medically Refractory Systemic Sclerosis (SSc)
1053633|NCT00685035|O3|Outcome|Perceived Effectiveness Higher Pressure/Variable Frequency|"Following each HFCWC session on day 1 and day 4, subjects completed a questionnaire that rated the comfort and efficacy of each HFCWC session using a 5-point scale. The questionnaire was entitled Post-Therapy Questionnaire. Scale range for how effective the HFCWC session was ranged from 1 (minimally effective) to 3 (neutral) to 5 (very effective)."
1053634|NCT00685035|O2|Outcome|Perceived Comfort Lower Pressure/Mid-frequency|"Following each HFCWC session on day 1 and day 4, subjects completed a questionnaire that rated the comfort of each HFCWC session using a 5-point scale. The questionnaire was entitled Post-Therapy Questionnaire. Scale range for comfort ranged from 1 (very uncomfortable) to 3 (neutral) to 5 (very comfortable)."
1053635|NCT00685035|O1|Outcome|Perceived Comfort Higher Pressure/Variable Frequency|"Following each HFCWC session on day 1 and day 4, subjects completed a questionnaire that rated the comfort of each HFCWC session using a 5-point scale. The questionnaire was entitled Post-Therapy Questionnaire. Scale range for comfort ranged from 1 (very uncomfortable) to 3 (neutral) to 5 (very comfortable)."
1053636|NCT00685035|O8|Outcome|"G Loss Modulus 100 Rad/Sec Lower Pressure/Mid-frequency"|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
1053637|NCT00685035|O7|Outcome|"G Loss Modulus 100 Rad/Sec Higher Pressure/Variable Frequency"|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
1053638|NCT00685035|O6|Outcome|"G Loss Modulus 1 Rad/Sec Lower Pressure/Mid-frequency"|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
1053639|NCT00685035|O5|Outcome|"G Loss Modulus 1 Rad/Sec Higher Pressure/Variable Frequency"|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
1053640|NCT00685035|O4|Outcome|G' Storage Modulus 100 Rad/Sec Lower Pressure/Mid-frequency|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
1053641|NCT00685035|O3|Outcome|G' Storage Modulus 100 Rad/Sec Higher Pressure/Variable Freq|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
1053656|NCT00684996|O1|Outcome|Phase I Bevacizumab (10 mg/kg) + MEDI-522|Patients receive bevacizumab (10/mg/kg or 5 mg/kg) IV over 30-90 minutes on days 1 and 15 and humanized monoclonal antibody MEDI-522 IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity un til the recommended phase II dose (RPTD) of bevacizumab is determined.
1053657|NCT00684996|O2|Outcome|Phase II Arm II|Patients receive bevacizumab IV as in arm I at the RPTD determined in phase I, and humanized monoclonal antibody MEDI-522 (8mg/kg) IV over 30 minutes on days 1, 8, 15, and 22.
1053642|NCT00685035|O2|Outcome|G' Storage Modulus at 1 Rad/Sec Lower Pressure/Mid-frequency|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
1053643|NCT00685035|O1|Outcome|G' Storage Modulus at 1 Rad/Sec Higher Pressure/Variable Freq|"Sputum was collected during the 15 minutes immediately following HFCWC sessions on day 1 and day 4. Half the subjects performed higher-pressure/mixed frequency HFCWC on Day 1 followed by lower pressure/mid-frequency HFCWC on Day 4. The other half of subjects performed lower pressure/mid-frequency on Day 1 followed by higer pressure/mixed-frequency on Day 4. Samples were studied with a rheometer (AR1000, TA Instruments, New Castle, Delaware) to assess the dynamic frequency range of stress-strain of a 20 microliter sputum sample over driving frequencies of 1–100 rad/s. Shear storage modulus (G') and shear loss modulus (G) were determined from these curves after nondestructive creep transformation. G' (or dynamic elasticity) measures stored energy and is a property of ideal solids. G is directly proportional to viscosity (viscosity x frequency) and is a property of ideal liquids."
1053644|NCT00685035|O4|Outcome|Change in FVC Pre vs Post Lower Pressure/Mid-frequency|Spirometry was performed prior to, and immediately following, all HCWC sessions on Day 1. Spirometry was performed immediately prior to, and immediately following, all HFCWC sessions on Day 4. Spirometry was performed according to American Thoracic Society/European Respiratory Society standards.
1053645|NCT00685035|O3|Outcome|Change in FVC Pre vs Post Higher Pressure/Variable Frequency|Spirometry was performed prior to, and immediately following, all HCWC sessions on Day 1. Spirometry was performed immediately prior to, and immediately following, all HFCWC sessions on Day 4. Spirometry was performed according to American Thoracic Society/European Respiratory Society standards.
1053646|NCT00685035|O2|Outcome|Change in FEV1 Pre vs Post Lower Pressure/Mid-frequency|Spirometry was performed prior to, and immediately following, all HCWC sessions on Day 1. Spirometry was performed immediately prior to, and immediately following, all HFCWC sessions on Day 4. Spirometry was performed according to American Thoracic Society/European Respiratory Society standards.
1053647|NCT00685035|O1|Outcome|Change in FEV1 Pre vs Post Higher Pressure/Variable Frequency|Spirometry was performed prior to, and immediately following, all HCWC sessions on Day 1. Spirometry was performed immediately prior to, and immediately following, all HFCWC sessions on Day 4. Spirometry was performed according to American Thoracic Society/European Respiratory Society standards.
1053648|NCT00685035|O4|Outcome|Sputum Dry Weight Lower Pressure/Mid-frequency|All sputum expectorated during all HFCWC sessions was collected in a pre-weighed specimen container and immediately sealed. Half the subjects used higher pressure/mixed frequency on day 1 followed by lower pressure/mid-frequency on day 4. Half the patients performed lower pressure/mid-frequency on day 1 followed by higher pressure/mixed frequency on day 4. All specimens were immediately centrifuged at 21,150 g for 15 min at 4°C, and the supernatant was completely removed to eliminate saliva. The container was then left open in an oven with the temperature set at 65°C for a minimum of 3 days to allow for complete desiccation. The sputum “dry weight” was calculated after re-weighing the container.
1053649|NCT00685035|O3|Outcome|Sputum Dry Weight Higher Pressure/Variable Frequency|All sputum expectorated during all HFCWC sessions was collected in a pre-weighed specimen container and immediately sealed. Half the subjects used higher pressure/mixed frequency on day 1 followed by lower pressure/mid-frequency on day 4. Half the patients performed lower pressure/mid-frequency on day 1 followed by higher pressure/mixed frequency on day 4. All specimens were immediately centrifuged at 21,150 g for 15 min at 4°C, and the supernatant was completely removed to eliminate saliva. The container was then left open in an oven with the temperature set at 65°C for a minimum of 3 days to allow for complete desiccation. The sputum “dry weight” was calculated after re-weighing the container.
1053650|NCT00685035|O2|Outcome|Sputum Wet Weight Lower Pressure/Mid-frequency|"All sputum expectorated during all HFCWC sessions was collected in a pre-weighed specimen container and immediately sealed. Half the subjects used higher pressure/mixed frequency on day 1 followed by lower pressure/mid-frequency on day 4. Half the patients performed lower pressure/mid-frequency on day 1 followed by higher pressure/mixed frequency on day 4. All specimens were immediately centrifuged at 21,150 g for 15 min at 4°C, and the supernatant was completely removed to eliminate saliva. The sputum wet weight was calculated after re-weighing the container with the sputum pellet."
1053651|NCT00685035|O1|Outcome|Sputum Wet Weight Higher Pressure/Variable Frequency|"All sputum expectorated during all HFCWC sessions was collected in a pre-weighed specimen container and immediately sealed. Half the subjects used higher pressure/mixed frequency on day 1 followed by lower pressure/mid-frequency on day 4. Half the patients performed lower pressure/mid-frequency on day 1 followed by higher pressure/mixed frequency on day 4. All specimens were immediately centrifuged at 21,150 g for 15 min at 4°C, and the supernatant was completely removed to eliminate saliva. The sputum wet weight was calculated after re-weighing the container with the sputum pellet."
1053652|NCT00685035|E2|Reported Event|Higher Pressure/Variable Frequency|
1053653|NCT00685035|E1|Reported Event|Lower Pressure/Mid-frequency|
1053654|NCT00684996|B1|Baseline|Phase I Bevacizumab (10 mg/kg) + MEDI-522|Patients receive bevacizumab (10 mg/kg or 5mg/kg) IV over 30-90 minutes on days 1 and 15 and humanized monoclonal antibody MEDI-522 IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until the recommended phase II dose (RPTD) of bevacizumab is determined.
1053655|NCT00684996|P1|Participant Flow|Phase I Bevacizumab (10 mg/kg) + MEDI-522|Patients receive bevacizumab (10/mg/kg or 5 mg/kg) IV over 30-90 minutes on days 1 and 15 and humanized monoclonal antibody MEDI-522 IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until the recommended phase II dose (RPTD) of bevacizumab is determined.
1053658|NCT00684996|O1|Outcome|Phase II Arm I|Patients receive bevacizumab (10mg/kg) IV over 30-90 minutes on days 1 and 15.
1054054|NCT00684138|O1|Outcome|ACRYSOF® ReSTOR® +3.0|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
1053661|NCT00684996|O2|Outcome|Phase II Arm II|Patients receive bevacizumab IV as in arm I at the RPTD determined in phase I, and humanized monoclonal antibody MEDI-522 (8mg/kg) IV over 30 minutes on days 1, 8, 15, and 22.
1053662|NCT00684996|O1|Outcome|Phase II Arm I|Patients receive bevacizumab (10mg/kg) IV over 30-90 minutes on days 1 and 15.
1053663|NCT00684996|O2|Outcome|Phase II Arm II|Patients receive bevacizumab IV as in arm I at the RPTD determined in phase I, and humanized monoclonal antibody MEDI-522 (8mg/kg) IV over 30 minutes on days 1, 8, 15, and 22.
1053664|NCT00684996|O1|Outcome|Phase II Arm I|Patients receive bevacizumab (10mg/kg) IV over 30-90 minutes on days 1 and 15.
1053665|NCT00684996|O1|Outcome|Phase I Bevacizumab (10 mg/kg) + MEDI-522|Patients receive bevacizumab (10 mg/kg or 5 mg/kg) IV over 30-90 minutes on days 1 and 15 and humanized monoclonal antibody MEDI-522 IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until the recommended phase II dose (RPTD) of bevacizumab is determined.
1053666|NCT00684996|E1|Reported Event|Phase I Bevacizumab (10 mg/kg) + MEDI-522|Patients receive bevacizumab (10/mg/kg or 5 mg/kg) IV over 30-90 minutes on days 1 and 15 and humanized monoclonal antibody MEDI-522 IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity until the recommended phase II dose (RPTD) of bevacizumab is determined.
1053667|NCT00684983|B3|Baseline|Total|Total of all reporting groups
1053668|NCT00684983|B2|Baseline|Arm B|Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
1053669|NCT00684983|B1|Baseline|Arm A|Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
1053670|NCT00684983|P2|Participant Flow|Arm B|Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
1053671|NCT00684983|P1|Participant Flow|Arm A|Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
1053672|NCT00684983|O2|Outcome|Arm B|Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
1053673|NCT00684983|O1|Outcome|Arm A|Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
1053674|NCT00684983|E2|Reported Event|Arm B|Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1½ hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO
1053675|NCT00684983|E1|Reported Event|Arm A|Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO
1053676|NCT00684814|B1|Baseline|Zolpidem Tartrate 10 mg Tablets and Ambien® 10 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast of at least 10 hours.
1053677|NCT00684814|P2|Participant Flow|Ambien® 10 mg Tablets Then Zolpidem Tartrate 10 mg Tablets|On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received one tablet of the reference formulation, Ambien® 10 mg, followed by a 7 day washout period. Then, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received a single tablet of the test formulation, zolpidem tartrate 10 mg.
1053678|NCT00684814|P1|Participant Flow|Zolpidem Tartrate 10 mg Tablets Then Ambien® 10 mg Tablets|On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received one tablet of the test formulation, zolpidem tartrate 10 mg, followed by a 7 day washout period. Then, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received a single tablet of the reference formulation, Ambien® 10 mg.
1053679|NCT00684814|O2|Outcome|Ambien® 10 mg Tablets|Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours.
1053680|NCT00684814|O1|Outcome|Zolpidem Tartrate 10 mg Tablets|Each subject received one tablet of zolpidem tartrate 10 mg after an overnight fast of at least 10 hours.
1053681|NCT00684814|O2|Outcome|Ambien® 10 mg Tablets|Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours.
1053682|NCT00684814|O1|Outcome|Zolpidem Tartrate 10 mg Tablets|Each subject received one tablet of zolpidem tartrate 10 mg after an overnight fast of at least 10 hours.
1053683|NCT00684814|O2|Outcome|Ambien® 10 mg Tablets|Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours.
1053684|NCT00684814|O1|Outcome|Zolpidem Tartrate 10 mg Tablets|Each subject received one tablet of zolpidem tartrate 10 mg after an overnight fast of at least 10 hours.
1053685|NCT00684814|E2|Reported Event|Ambien® 10 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast.
1053686|NCT00684814|E1|Reported Event|Zolpidem Tartrate 10 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast.
1053741|NCT00684671|O3|Outcome|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
1053687|NCT00684762|B1|Baseline|Cilostazol 100 mg Tablets and Pletal® 100 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Cilostazol 100 mg or Pletal® 100 mg following an overnight fast of at least 10 hours.
1053688|NCT00684762|P2|Participant Flow|Pletal® 100 mg Tablets Then Cilostazol 100 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, Cilostazol 100 mg, after an overnight fast of at least 10 hours.
1053689|NCT00684762|P1|Participant Flow|Cilostazol 100 mg Tablets Then Pletal® 100 mg Tablets|On the morning of Day 1 subjects received one tablet of the test formulation, Cilostazol 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours.
1053690|NCT00684762|O2|Outcome|Pletal® 100 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, Cilostazol 100 mg, after an overnight fast of at least 10 hours.
1053691|NCT00684762|O1|Outcome|Cilostazol 100 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, cilostazol 100mg, or the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
1053692|NCT00684762|O2|Outcome|Pletal® 100 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, Cilostazol 100 mg, after an overnight fast of at least 10 hours.
1053693|NCT00684762|O1|Outcome|Cilostazol 100 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, cilostazol 100mg, or the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
1053694|NCT00684762|O2|Outcome|Pletal® 100 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, Cilostazol 100 mg, after an overnight fast of at least 10 hours.
1053695|NCT00684762|O1|Outcome|Cilostazol 100 mg Tablets|On the morning of Day 1 subjects received one tablet of either the test formulation, cilostazol 100mg, or the reference formulation, Pletal® 100 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
1053696|NCT00684762|E2|Reported Event|Pletal® 100 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either cilostazol 100 mg or Pletal® 100 mg following an overnight fast of at least 10 hours.
1053697|NCT00684762|E1|Reported Event|Cilostazol 100 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either cilostazol 100 mg or Pletal® 100 mg following an overnight fast of at least 10 hours.
1053698|NCT00684749|B1|Baseline|Total Population|All surgical patients
1053699|NCT00684749|P1|Participant Flow|Total Population|All surgical patients
1053700|NCT00684749|O1|Outcome|Total Population|All surgical patients
1053701|NCT00684749|E1|Reported Event|Total Population|All surgical patients
1053702|NCT00684723|B1|Baseline|Lovastatin 40 mg Tablets and Mevacor® 40 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
1053703|NCT00684723|P2|Participant Flow|Mevacor® 40 mg Tablets Then Lovastatin 40 mg Tablets|On the morning of Day 1, subjects received one tablet of the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received one tablet of the test formulation, Lovastatin 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
1053704|NCT00684723|P1|Participant Flow|Lovastatin 40 mg Tablets Then Mevacor® 40 mg Tablets|On the morning of Day 1, subjects received one tablet of the test formulation, Lovastatin 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received one tablet of the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
1053705|NCT00684723|O2|Outcome|Mevacor® 40 mg Tablets|On the morning of Day 1, subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received the alternate regimen thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
1053706|NCT00684723|O1|Outcome|Lovastatin 40 mg Tablets|On the morning of Day 1, subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received the alternate regimen thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
1053707|NCT00684723|O2|Outcome|Mevacor® 40 mg Tablets|On the morning of Day 1, subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received the alternate regimen thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
1053743|NCT00684671|O1|Outcome|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
1053708|NCT00684723|O1|Outcome|Lovastatin 40 mg Tablets|On the morning of Day 1, subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received the alternate regimen thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
1053709|NCT00684723|O2|Outcome|Mevacor® 40 mg Tablets|On the morning of Day 1, subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received the alternate regimen thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
1053710|NCT00684723|O1|Outcome|Lovastatin 40 mg Tablets|On the morning of Day 1, subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received the alternate regimen thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
1053711|NCT00684723|E2|Reported Event|Mevacor® 40 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg thirty minutes after the start of a standardized high-fat, high- calorie breakfast.
1053712|NCT00684723|E1|Reported Event|Lovastatin 40 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
1053713|NCT00684671|B4|Baseline|Total|Total of all reporting groups
1053714|NCT00684671|B3|Baseline|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
1053715|NCT00684671|B2|Baseline|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
1053716|NCT00684671|B1|Baseline|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
1053717|NCT00684671|P3|Participant Flow|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
1053718|NCT00684671|P2|Participant Flow|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
1053719|NCT00684671|P1|Participant Flow|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
1053720|NCT00684671|O3|Outcome|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
1053721|NCT00684671|O2|Outcome|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
1053722|NCT00684671|O1|Outcome|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
1053723|NCT00684671|O3|Outcome|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
1053724|NCT00684671|O2|Outcome|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
1053725|NCT00684671|O1|Outcome|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
1053726|NCT00684671|O3|Outcome|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
1053727|NCT00684671|O2|Outcome|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
1053728|NCT00684671|O1|Outcome|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
1053729|NCT00684671|O3|Outcome|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
1053730|NCT00684671|O2|Outcome|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
1053731|NCT00684671|O1|Outcome|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
1053732|NCT00684671|O3|Outcome|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
1053733|NCT00684671|O2|Outcome|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
1053734|NCT00684671|O1|Outcome|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
1053735|NCT00684671|O3|Outcome|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
1053736|NCT00684671|O2|Outcome|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
1053737|NCT00684671|O1|Outcome|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
1053738|NCT00684671|O3|Outcome|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
1053739|NCT00684671|O2|Outcome|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
1053740|NCT00684671|O1|Outcome|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
1054055|NCT00684138|O2|Outcome|ACRYSOF® ReSTOR® Aspheric +4.0|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
1053744|NCT00684671|E3|Reported Event|HB VAX PRO + Vaqta Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
1053745|NCT00684671|E2|Reported Event|Engerix + Havrix Group|Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
1053746|NCT00684671|E1|Reported Event|Twinrix Group|Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
1053747|NCT00684645|B1|Baseline|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
1053748|NCT00684645|P1|Participant Flow|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
1053749|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
1053750|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
1053751|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
1053752|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
1053753|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
1053754|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
1053755|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
1053756|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
1053757|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
1053758|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
1053759|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
1053760|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
1053761|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
1053762|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
1053763|NCT00684645|O1|Outcome|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
1053764|NCT00684645|E1|Reported Event|Sunitinib|The use and dosage recommendations for Sunitinib (Sutent) were in accordance with the local Summary of Product Characteristics.
1053765|NCT00684593|B3|Baseline|Total|Total of all reporting groups
1053766|NCT00684593|B2|Baseline|Placebo|Matching placebo to Navarixin administered orally once daily for 28 days.
1053767|NCT00684593|B1|Baseline|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
1053768|NCT00684593|P2|Participant Flow|Placebo|Matching placebo to Navarixin administered orally once daily for 28 days.
1053769|NCT00684593|P1|Participant Flow|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
1053770|NCT00684593|O1|Outcome|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
1053771|NCT00684593|O1|Outcome|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
1053772|NCT00684593|O1|Outcome|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
1053773|NCT00684593|O1|Outcome|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
1053774|NCT00684593|O2|Outcome|Placebo|Matching placebo to SCH 527123 administered orally once daily for 28 days.
1053775|NCT00684593|O1|Outcome|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
1053776|NCT00684593|O2|Outcome|Placebo|Matching placebo to SCH 527123 administered orally once daily for 28 days.
1053777|NCT00684593|O1|Outcome|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
1053778|NCT00684593|E2|Reported Event|Placebo|Matching placebo to Navarixin administered orally once daily for 28 days.
1053779|NCT00684593|E1|Reported Event|Navarixin|Navarixin 30 mg administered orally once daily for 28 days.
1053780|NCT00684567|B1|Baseline|Radiotherapy/Temozolomide|It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
1053781|NCT00684567|P1|Participant Flow|Radiotherapy/Temozolomide|It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
1053782|NCT00684567|O1|Outcome|Radiotherapy/Temozolomide|It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
1053783|NCT00684567|O1|Outcome|Radiotherapy/Temozolomide|It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
1053784|NCT00684567|O1|Outcome|Radiotherapy/Temozolomide|It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
1053785|NCT00684567|O1|Outcome|Radiotherapy/Temozolomide|It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
1053786|NCT00684567|O1|Outcome|Radiotherapy/Temozolomide|It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
1053787|NCT00684567|E1|Reported Event|Radiotherapy/Temozolomide|
1053788|NCT00684554|B3|Baseline|Total|Total of all reporting groups
1054430|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
1053789|NCT00684554|B2|Baseline|Observed|"Buprenorphine Observed in office induction~Buprenorphine: Dose is determined according to the participants' individual need."
1053790|NCT00684554|B1|Baseline|Unobserved-at Home|"Buprenorphine Unobserved at home induction~Buprenorphine: Dose is determined according to the participants' individual need."
1053791|NCT00684554|P2|Participant Flow|Observed|"Buprenorphine Observed in office induction~Buprenorphine: Dose is determined according to the participants' individual need."
1053792|NCT00684554|P1|Participant Flow|Unobserved-at Home|"Buprenorphine Unobserved at home induction~Buprenorphine: Dose is determined according to the participants' individual need."
1053793|NCT00684554|O2|Outcome|Observed|"Buprenorphine Observed in office induction~Buprenorphine: Dose is determined according to the participants' individual need."
1053794|NCT00684554|O1|Outcome|Unobserved-at Home|"Buprenorphine Unobserved at home induction~Buprenorphine: Dose is determined according to the participants' individual need."
1053795|NCT00684554|O2|Outcome|Observed|"Buprenorphine Observed in office induction~Buprenorphine: Dose is determined according to the participants' individual need."
1053796|NCT00684554|O1|Outcome|Unobserved-at Home|"Buprenorphine Unobserved at home induction~Buprenorphine: Dose is determined according to the participants' individual need."
1053797|NCT00684554|E2|Reported Event|Observed|"Buprenorphine Observed in office induction~Buprenorphine: Dose is determined according to the participants' individual need."
1053798|NCT00684554|E1|Reported Event|Unobserved-at Home|"Buprenorphine Unobserved at home induction~Buprenorphine: Dose is determined according to the participants' individual need."
1053799|NCT00684541|B3|Baseline|Total|Total of all reporting groups
1053800|NCT00684541|B2|Baseline|Interpretation Control Condition|The ICC was identical to the IMP, except that participants received positive feedback when they endorsed threat interpretations on half (50%) of the trials and negative feedback when they endorsed threat interpretations for the remaining half (50%) of trials. This frequency was the same for benign interpretations. Thus, the control group was reinforced equally for making threat and benign interpretations. The ICC was not intended to change interpretation significantly in either direction.
1053801|NCT00684541|B1|Baseline|Interpretation Modification Program|The IMP procedure was identical to the word-sentence association paradigm (WSAP; Beard & Amir, 2009) except participants received feedback about their responses. Participants received positive feedback when they endorsed benign interpretations or rejected threat interpretations of the ambiguous sentences on 100% of trials and negative feedback when they endorsed threat interpretations or rejected benign interpretations on 100% of trials. This feedback manipulation was intended to reinforce a benign interpretation bias and extinguish the threat interpretation bias. Participants completed two blocks of 110 training trials in each session. Participants who completed Set A during the WSAP assessment saw Set B during the IMP and vice versa. Each IMP session lasted approximately 20 min.
1053802|NCT00684541|P2|Participant Flow|Interpretation Control Condition (ICC)|The ICC was identical to the IMP, except that participants received positive feedback when they endorsed threat interpretations on half (50%) of the trials and negative feedback when they endorsed threat interpretations for the remaining half (50%) of trials. This frequency was the same for benign interpretations. Thus, the control group was reinforced equally for making threat and benign interpretations. The ICC was not intended to change interpretation significantly in either direction.
1053803|NCT00684541|P1|Participant Flow|Interpretation Modification Program (IMP)|The IMP procedure was identical to the word-sentence association paradigm (WSAP; Beard & Amir, 2009) except that participants received feedback about their responses. Specifically, participants received positive feedback when they endorsed benign interpretations or rejected threat interpretations of the ambiguous sentences on 100% of trials. Participants received negative feedback when they endorsed threat interpretations or rejected benign interpretations on 100% of trials. This feedback manipulation was intended to reinforce a benign interpretation bias and extinguish the threat interpretation bias. Participants completed two blocks of 110 training trials (76 social and 34 nonsocial) in each session. Participants who completed Set A during the WSAP assessment saw Set B during the IMP and vice versa. Thus, participants were assessed with different materials than those seen during the IMP. Each IMP session lasted approximately 20 min.
1053804|NCT00684541|O2|Outcome|Interpretation Control Condition|"The ICC was identical to the IMP, except that participants received positive feedback when they endorsed threat interpretations on half (50%) of the trials and negative feedback when they endorsed threat interpretations for the remaining half (50%) of trials. This frequency was the same for benign interpretations. Thus, the control group was reinforced equally for making threat and benign interpretations. The ICC was not intended to change interpretation significantly in either direction.~Interpretation Control Condition: Participants assigned to the PC completed an identical procedure to the IMP procedure except that feedback about participants' performance was not contingent on the type of interpretation (i.e., non-threat or threat) endorsed. Thus, participants in the PC received positive feedback 50% of the time when viewing a threat interpretation and 50% of the time when viewing a non-threat interpretation."
1053805|NCT00684541|O1|Outcome|Interpretation Modification Program|The IMP procedure was identical to the word-sentence association paradigm (WSAP; Beard & Amir, 2009) except participants received feedback about their responses. Participants received positive feedback when they endorsed benign interpretations or rejected threat interpretations of the ambiguous sentences on 100% of trials and negative feedback when they endorsed threat interpretations or rejected benign interpretations on 100% of trials. This feedback manipulation was intended to reinforce a benign interpretation bias and extinguish the threat interpretation bias. Participants completed two blocks of 110 training trials in each session. Participants who completed Set A during the WSAP assessment saw Set B during the IMP and vice versa. Each IMP session lasted approximately 20 min.
1053806|NCT00684541|O2|Outcome|Interpretation Control Condition|The ICC was identical to the IMP, except that participants received positive feedback when they endorsed threat interpretations on half (50%) of the trials and negative feedback when they endorsed threat interpretations for the remaining half (50%) of trials. This frequency was the same for benign interpretations. Thus, the control group was reinforced equally for making threat and benign interpretations. The ICC was not intended to change interpretation significantly in either direction.
1053847|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
1053848|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
1053807|NCT00684541|O1|Outcome|Interpretation Modification Program|The IMP procedure was identical to the word-sentence association paradigm (WSAP; Beard & Amir, 2009) except participants received feedback about their responses. Participants received positive feedback when they endorsed benign interpretations or rejected threat interpretations of the ambiguous sentences on 100% of trials and negative feedback when they endorsed threat interpretations or rejected benign interpretations on 100% of trials. This feedback manipulation was intended to reinforce a benign interpretation bias and extinguish the threat interpretation bias. Participants completed two blocks of 110 training trials in each session. Participants who completed Set A during the WSAP assessment saw Set B during the IMP and vice versa. Each IMP session lasted approximately 20 min.
1053808|NCT00684541|E2|Reported Event|Interpretation Control Condition|The ICC was identical to the IMP, except that participants received positive feedback when they endorsed threat interpretations on half (50%) of the trials and negative feedback when they endorsed threat interpretations for the remaining half (50%) of trials. This frequency was the same for benign interpretations. Thus, the control group was reinforced equally for making threat and benign interpretations. The ICC was not intended to change interpretation significantly in either direction.
1053809|NCT00684541|E1|Reported Event|Interpretation Modification Program|The IMP procedure was identical to the word-sentence association paradigm (WSAP; Beard & Amir, 2009) except participants received feedback about their responses. Participants received positive feedback when they endorsed benign interpretations or rejected threat interpretations of the ambiguous sentences on 100% of trials and negative feedback when they endorsed threat interpretations or rejected benign interpretations on 100% of trials. This feedback manipulation was intended to reinforce a benign interpretation bias and extinguish the threat interpretation bias. Participants completed two blocks of 110 training trials in each session. Participants who completed Set A during the WSAP assessment saw Set B during the IMP and vice versa. Each IMP session lasted approximately 20 min.
1053810|NCT00684515|B4|Baseline|Total|Total of all reporting groups
1053811|NCT00684515|B3|Baseline|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
1053812|NCT00684515|B2|Baseline|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
1053813|NCT00684515|B1|Baseline|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
1053814|NCT00684515|P3|Participant Flow|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
1053815|NCT00684515|P2|Participant Flow|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
1053816|NCT00684515|P1|Participant Flow|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
1053817|NCT00684515|O3|Outcome|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
1053818|NCT00684515|O2|Outcome|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
1053819|NCT00684515|O1|Outcome|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
1053820|NCT00684515|O3|Outcome|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
1053821|NCT00684515|O2|Outcome|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
1053822|NCT00684515|O1|Outcome|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
1053823|NCT00684515|O3|Outcome|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
1053824|NCT00684515|O2|Outcome|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
1053825|NCT00684515|O1|Outcome|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
1053826|NCT00684515|O3|Outcome|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
1053827|NCT00684515|O2|Outcome|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
1053828|NCT00684515|O1|Outcome|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
1053829|NCT00684515|O3|Outcome|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
1053830|NCT00684515|O2|Outcome|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
1053831|NCT00684515|O1|Outcome|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
1053832|NCT00684515|O3|Outcome|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
1053833|NCT00684515|O2|Outcome|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
1053834|NCT00684515|O1|Outcome|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
1053835|NCT00684515|E3|Reported Event|Placebo|Matching placbo tablets to Vorapaxar administered orally once daily for 60 days.
1053836|NCT00684515|E2|Reported Event|Vorapaxar 2.5 mg|Vorapaxar 2.5 mg tablets administered orally once daily for 60 days.
1053837|NCT00684515|E1|Reported Event|Vorapaxar 1 mg|Vorapaxar 1 mg tablets administered orally once daily for 60 days.
1053838|NCT00684424|B1|Baseline|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
1053839|NCT00684424|P1|Participant Flow|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
1053840|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
1053841|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
1053842|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
1053843|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
1053844|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
1053845|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
1053846|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
1053849|NCT00684424|O1|Outcome|Pregabalin|
1054431|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
1053850|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
1053851|NCT00684424|O1|Outcome|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
1053852|NCT00684424|E1|Reported Event|Pregabalin (Lyrica)|Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
1053853|NCT00684411|B1|Baseline|Imatinib Mesylate|The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
1053854|NCT00684411|P1|Participant Flow|Imatinib Mesylate|The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
1053855|NCT00684411|O1|Outcome|Imatinib Mesylate|The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
1053856|NCT00684411|O1|Outcome|Imatinib Mesylate|The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
1053857|NCT00684411|O1|Outcome|Imatinib Mesylate|The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
1053858|NCT00684411|E1|Reported Event|Imatinib Mesylate|The initial starting dose of imatinib mesylate was 400 mg by mouth once daily but intra-patient dose escalation for patients who did not achieve complete response (CR) was built in upon restaging at weeks 8 and 16. At week 8, patients with partial response (PR) or stable disease (SD) were dose escalated to 600 mg. At week 16, if these patients continued in PR or SD, dose escalated to 800 mg and for patients on 400 mg dose escalated to 600 mg. Patients who experienced disease progression could be dose escalated per MD discretion. Patients were treated as long as receiving clinical benefit and no unacceptable toxicity.
1053859|NCT00684320|B3|Baseline|Total|Total of all reporting groups
1053860|NCT00684320|B2|Baseline|1 Attention Disengagement Training (ADT)|Those assigned to ADT condition will receive a computer delivered attention retraining protocol designed to enhance attention disengagement from socially threatening stimuli. The ADT protocol includes eight 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). During each session, participants will see 320 trials that consist of the various combinations of probe type (E or F) probe position (top or bottom), and emotion type (Neutral, Disgust, Anger). 256 trials will include one neutral face and one disgust face or one angry face: 2 (probe type) X 2 (probe position) X 16 (person) X 4 (repetitions). On trials where participants see one neutral face and one disgust or angry face (i.e., 80% of the trials), the probe will always follow the neutral face.
1053861|NCT00684320|B1|Baseline|2 Placebo Condition (PC)|"The placebo, group will complete the PC procedure, which is identical to the ADT procedure except that during the presentation of the trials where a disgust or angry face is present, the probe will appear with equal frequency in the position of disgust or angry and neutral face. Thus, disgust, angry nor neutral face will have signal value regarding the position of the probe.~Placebo Condition: The placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat picture is present, the probe will appear with equal frequency in the position of threat and neutral pictures. Thus, neither threat nor neutral pictures have signal value with regard to the position of the probe."
1053862|NCT00684320|P2|Participant Flow|1 Attention Disengagement Training (ADT)|Those assigned to ADT condition will receive a computer delivered attention retraining protocol designed to enhance attention disengagement from socially threatening stimuli. The ADT protocol includes eight 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). During each session, participants will see 320 trials that consist of the various combinations of probe type (E or F) probe position (top or bottom), and emotion type (Neutral, Disgust, Anger). 256 trials will include one neutral face and one disgust face or one angry face: 2 (probe type) X 2 (probe position) X 16 (person) X 4 (repetitions). On trials where participants see one neutral face and one disgust or angry face (i.e., 80% of the trials), the probe will always follow the neutral face.
1053896|NCT00684307|O5|Outcome|VKA INR 2-3|
1053897|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
1053898|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
1053899|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
1053900|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
1053901|NCT00684307|O5|Outcome|VKA INR 2-3|
1053902|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
1053903|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
1053863|NCT00684320|P1|Participant Flow|2 Placebo Condition (PC)|"The placebo, group will complete the PC procedure, which is identical to the ADT procedure except that during the presentation of the trials where a disgust or angry face is present, the probe will appear with equal frequency in the position of disgust or angry and neutral face. Thus, disgust, angry nor neutral face will have signal value regarding the position of the probe.~Placebo Condition: The placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat picture is present, the probe will appear with equal frequency in the position of threat and neutral pictures. Thus, neither threat nor neutral pictures have signal value with regard to the position of the probe."
1053864|NCT00684320|O2|Outcome|1 Attention Disengagement Training (ADT)|Those assigned to ADT condition will receive a computer delivered attention retraining protocol designed to enhance attention disengagement from socially threatening stimuli. The ADT protocol includes eight 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). During each session, participants will see 320 trials that consist of the various combinations of probe type (E or F) probe position (top or bottom), and emotion type (Neutral, Disgust, Anger). 256 trials will include one neutral face and one disgust face or one angry face: 2 (probe type) X 2 (probe position) X 16 (person) X 4 (repetitions). On trials where participants see one neutral face and one disgust or angry face (i.e., 80% of the trials), the probe will always follow the neutral face.
1053865|NCT00684320|O1|Outcome|2 Placebo Condition (PC)|"The placebo, group will complete the PC procedure, which is identical to the ADT procedure except that during the presentation of the trials where a disgust or angry face is present, the probe will appear with equal frequency in the position of disgust or angry and neutral face. Thus, disgust, angry nor neutral face will have signal value regarding the position of the probe.~Placebo Condition: The placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat picture is present, the probe will appear with equal frequency in the position of threat and neutral pictures. Thus, neither threat nor neutral pictures have signal value with regard to the position of the probe."
1053866|NCT00684320|O2|Outcome|1 Attention Disengagement Training (ADT)|Those assigned to ADT condition will receive a computer delivered attention retraining protocol designed to enhance attention disengagement from socially threatening stimuli. The ADT protocol includes eight 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). During each session, participants will see 320 trials that consist of the various combinations of probe type (E or F) probe position (top or bottom), and emotion type (Neutral, Disgust, Anger). 256 trials will include one neutral face and one disgust face or one angry face: 2 (probe type) X 2 (probe position) X 16 (person) X 4 (repetitions). On trials where participants see one neutral face and one disgust or angry face (i.e., 80% of the trials), the probe will always follow the neutral face.
1053867|NCT00684320|O1|Outcome|2 Placebo Condition (PC)|"The placebo, group will complete the PC procedure, which is identical to the ADT procedure except that during the presentation of the trials where a disgust or angry face is present, the probe will appear with equal frequency in the position of disgust or angry and neutral face. Thus, disgust, angry nor neutral face will have signal value regarding the position of the probe.~Placebo Condition: The placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat picture is present, the probe will appear with equal frequency in the position of threat and neutral pictures. Thus, neither threat nor neutral pictures have signal value with regard to the position of the probe."
1053868|NCT00684320|E2|Reported Event|1 Attention Disengagement Training (ADT)|Those assigned to ADT condition will receive a computer delivered attention retraining protocol designed to enhance attention disengagement from socially threatening stimuli. The ADT protocol includes eight 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). During each session, participants will see 320 trials that consist of the various combinations of probe type (E or F) probe position (top or bottom), and emotion type (Neutral, Disgust, Anger). 256 trials will include one neutral face and one disgust face or one angry face: 2 (probe type) X 2 (probe position) X 16 (person) X 4 (repetitions). On trials where participants see one neutral face and one disgust or angry face (i.e., 80% of the trials), the probe will always follow the neutral face.
1053869|NCT00684320|E1|Reported Event|2 Placebo Condition (PC)|"The placebo, group will complete the PC procedure, which is identical to the ADT procedure except that during the presentation of the trials where a disgust or angry face is present, the probe will appear with equal frequency in the position of disgust or angry and neutral face. Thus, disgust, angry nor neutral face will have signal value regarding the position of the probe.~Placebo Condition: The placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat picture is present, the probe will appear with equal frequency in the position of threat and neutral pictures. Thus, neither threat nor neutral pictures have signal value with regard to the position of the probe."
1053870|NCT00684307|B6|Baseline|Total|Total of all reporting groups
1053871|NCT00684307|B5|Baseline|VKA INR 2-3|
1053872|NCT00684307|B4|Baseline|200 mg bd|AZD0837 200 mg bd
1053873|NCT00684307|B3|Baseline|450 mg od|AZD0837 450 mg od
1053874|NCT00684307|B2|Baseline|300 mg od|AZD0837 300 mg od
1053875|NCT00684307|B1|Baseline|150 mg od|AZD0837 150 mg od
1053876|NCT00684307|P5|Participant Flow|VKA INR 2-3|
1053877|NCT00684307|P4|Participant Flow|200 mg bd|AZD0837 200 mg bd
1053878|NCT00684307|P3|Participant Flow|450 mg od|AZD0837 450 mg od
1053879|NCT00684307|P2|Participant Flow|300 mg od|AZD0837 300 mg od
1053880|NCT00684307|P1|Participant Flow|150 mg od|AZD0837 150 mg od
1053881|NCT00684307|O5|Outcome|VKA INR 2-3|
1053882|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
1053883|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
1053884|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
1053885|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
1053886|NCT00684307|O5|Outcome|VKA INR 2-3|
1053887|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
1053888|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
1053889|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
1053890|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
1053891|NCT00684307|O5|Outcome|VKA INR 2-3|
1053892|NCT00684307|O4|Outcome|200 mg bd|AZD0837 200 mg bd
1053893|NCT00684307|O3|Outcome|450 mg od|AZD0837 450 mg od
1053894|NCT00684307|O2|Outcome|300 mg od|AZD0837 300 mg od
1053895|NCT00684307|O1|Outcome|150 mg od|AZD0837 150 mg od
1053947|NCT00684255|P1|Participant Flow|Reduced Intensity Regimen SSc|Reduced Intensity Regimen Medically Refractory Systemic Sclerosis (SSc)
1053948|NCT00684255|O2|Outcome|Systemic Sclerosis (SSc)|Reduced Intensity Regimen of Fludarabine/Busulfan and Campath Followed by alloSCT in patients with Systemic Sclerosis (SSc)
1053949|NCT00684255|O1|Outcome|Medically Refractory Systemic Lupus Erythematosus (SLE)|Reduced Intensity Regimen of Fludarabine/Busulfan and Campath Followed by alloSCT in patients with Medically Refractory Systemic Lupus Erythematosus (SLE)
1053950|NCT00684255|E1|Reported Event|Reduced Intensity Regimen SSc|Reduced Intensity Regimen Medically Refractory Systemic Sclerosis (SSc)
1053951|NCT00684242|B1|Baseline|Lenalidomide|10 mg by mouth daily
1053952|NCT00684242|P1|Participant Flow|Lenalidomide|10 mg by mouth daily
1053953|NCT00684242|O1|Outcome|Lenalidomide|10 mg by mouth daily
1053954|NCT00684242|E1|Reported Event|Lenalidomide|10 mg by mouth daily
1053955|NCT00684203|B7|Baseline|Total|Total of all reporting groups
1053956|NCT00684203|B6|Baseline|Placebo/Placebo (Non-PCI)|Placebo as loading dose is administered as the initial dose to non-PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053957|NCT00684203|B5|Baseline|Vorapaxar 40 mg (Non-PCI)|Vorapaxar 40 mg as loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053958|NCT00684203|B4|Baseline|Vorapaxar 20 mg (Non-PCI)|Vorapaxar 20 mg as a loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration 60 days).
1053959|NCT00684203|B3|Baseline|Placebo/Placebo (PCI)|Placebo as loading dose is administered as the initial dose to PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053960|NCT00684203|B2|Baseline|Vorapaxar 40 mg (PCI)|Vorapaxar 40 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053961|NCT00684203|B1|Baseline|Vorapaxar 20 mg (PCI)|Vorapaxar 20 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053962|NCT00684203|P6|Participant Flow|Placebo/Placebo (Non-PCI)|Placebo as loading dose is administered as the initial dose to non-PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053963|NCT00684203|P5|Participant Flow|Vorapaxar 40 mg (Non-PCI)|Vorapaxar 40 mg as loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053964|NCT00684203|P4|Participant Flow|Vorapaxar 20 mg (Non-PCI)|Vorapaxar 20 mg as a loading dose is administered to non-PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration 60 days).
1053965|NCT00684203|P3|Participant Flow|Placebo/Placebo (PCI)|Placebo as loading dose is administered as the initial dose to PCI participants. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053966|NCT00684203|P2|Participant Flow|Vorapaxar 40 mg (PCI)|Vorapaxar 40 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053967|NCT00684203|P1|Participant Flow|Vorapaxar 20 mg (PCI)|Vorapaxar 20 mg as loading dose is administered to PCI participants as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053968|NCT00684203|O3|Outcome|Placebo/Placebo Non-PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053969|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose Non-PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053970|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose Non-PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053971|NCT00684203|O3|Outcome|Placebo/Placebo Non-PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053972|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose Non-PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053973|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose Non-PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053974|NCT00684203|O3|Outcome|Placebo/Placebo Non-PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053975|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose Non-PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053976|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose Non-PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053977|NCT00684203|O3|Outcome|Placebo/Placebo Non-PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053978|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose Non-PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1054056|NCT00684138|O1|Outcome|ACRYSOF® ReSTOR® +3.0|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
1054432|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
1053979|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose Non-PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053980|NCT00684203|O3|Outcome|Placebo/Placebo Non-PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053981|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose Non-PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053982|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose Non-PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053983|NCT00684203|O3|Outcome|Placebo/Placebo Non-PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053984|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose Non-PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053985|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose Non-PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053986|NCT00684203|O3|Outcome|Placebo/Placebo Non-PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053987|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose Non-PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053988|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose Non-PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053989|NCT00684203|O3|Outcome|Placebo/Placebo Non-PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053990|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose Non-PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053991|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose Non-PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053992|NCT00684203|O5|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053993|NCT00684203|O4|Outcome|Vorapaxar 40 mg/2.5 mg PCI|Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053994|NCT00684203|O3|Outcome|Vorapaxar 40 mg/1 mg PCI|Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053995|NCT00684203|O2|Outcome|Vorapaxar 20 mg/2.5 mg PCI|Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053996|NCT00684203|O1|Outcome|Vorapaxar 20 mg/1 mg PCI|Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053997|NCT00684203|O3|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053998|NCT00684203|O2|Outcome|Vorapaxar 2.5 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1053999|NCT00684203|O1|Outcome|Vorapaxar 1 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1054000|NCT00684203|O3|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1054001|NCT00684203|O2|Outcome|Vorapaxar 2.5 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1054002|NCT00684203|O1|Outcome|Vorapaxar 1 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1054003|NCT00684203|O3|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1054004|NCT00684203|O2|Outcome|Vorapaxar 2.5 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1054005|NCT00684203|O1|Outcome|Vorapaxar 1 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1054006|NCT00684203|O3|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1054007|NCT00684203|O2|Outcome|Vorapaxar 2.5 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1054057|NCT00684138|O2|Outcome|ACRYSOF® ReSTOR® Aspheric +4.0|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
1054008|NCT00684203|O1|Outcome|Vorapaxar 1 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1054009|NCT00684203|O3|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1054010|NCT00684203|O2|Outcome|Vorapaxar 2.5 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1054011|NCT00684203|O1|Outcome|Vorapaxar 1 mg Maintenance Dose PCI|Vorapaxar 20 mg or 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1054012|NCT00684203|O5|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1054013|NCT00684203|O4|Outcome|Vorapaxar 40 mg/2.5 mg PCI|Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1054014|NCT00684203|O3|Outcome|Vorapaxar 40 mg/1 mg PCI|Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1054015|NCT00684203|O2|Outcome|Vorapaxar 20 mg/2.5 mg PCI|Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1054016|NCT00684203|O1|Outcome|Vorapaxar 20 mg/1 mg PCI|Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1054017|NCT00684203|O3|Outcome|Placebo/Placebo PCI|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1054018|NCT00684203|O2|Outcome|Vorapaxar 40 mg Loading Dose PCI|Vorapaxar 40 mg as a loading dose is administered as the initial dose. From Day 2, 1 mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1054019|NCT00684203|O1|Outcome|Vorapaxar 20 mg Loading Dose PCI|Vorapaxar 20 mg as a loading dose is administered as the initial dose. From Day 2, 1mg or 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1054020|NCT00684203|E5|Reported Event|Placebo/Placebo|Placebo as loading dose is administered as the initial dose. From Day 2, placebo once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1054021|NCT00684203|E4|Reported Event|Vorapaxar 40 mg/2.5 mg|Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1054022|NCT00684203|E3|Reported Event|Vorapaxar 40 mg/1 mg|Vorapaxar 40 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1054023|NCT00684203|E2|Reported Event|Vorapaxar 20 mg/2.5 mg|Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 2.5 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1054024|NCT00684203|E1|Reported Event|Vorapaxar 20 mg/1 mg|Vorapaxar 20 mg as loading dose is administered as the initial dose. From Day 2, 1 mg once daily is administered as the maintenance dose for 59 days (total duration of 60 days).
1054025|NCT00684177|B3|Baseline|Total|Total of all reporting groups
1054026|NCT00684177|B2|Baseline|Placebo|Matching placebo
1054027|NCT00684177|B1|Baseline|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
1054028|NCT00684177|P2|Participant Flow|Placebo|Matching placebo
1054029|NCT00684177|P1|Participant Flow|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
1054030|NCT00684177|O2|Outcome|Placebo|Matching placebo
1054031|NCT00684177|O1|Outcome|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
1054032|NCT00684177|O2|Outcome|Placebo|Matching placebo
1054033|NCT00684177|O1|Outcome|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
1054034|NCT00684177|O2|Outcome|Placebo|Matching placebo
1054035|NCT00684177|O1|Outcome|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
1054036|NCT00684177|O2|Outcome|Placebo|Matching placebo
1054037|NCT00684177|O1|Outcome|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
1054038|NCT00684177|O2|Outcome|Placebo|Matching placebo
1054039|NCT00684177|O1|Outcome|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
1054040|NCT00684177|O2|Outcome|Placebo|Matching placebo
1054041|NCT00684177|O1|Outcome|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
1054042|NCT00684177|E2|Reported Event|Placebo|Matching placebo
1054043|NCT00684177|E1|Reported Event|Retapamulin|Topical retapamulin ointment, 1% twice daily for 5 days
1054044|NCT00684138|B3|Baseline|Total|Total of all reporting groups
1054045|NCT00684138|B2|Baseline|ACRYSOF® ReSTOR® Aspheric +4.0|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
1054046|NCT00684138|B1|Baseline|ACRYSOF® ReSTOR® +3.0|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
1054047|NCT00684138|P2|Participant Flow|ACRYSOF® ReSTOR® Aspheric +4.0|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
1054048|NCT00684138|P1|Participant Flow|ACRYSOF® ReSTOR® +3.0|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
1054049|NCT00684138|O2|Outcome|ACRYSOF® ReSTOR® Aspheric +4.0|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
1054050|NCT00684138|O1|Outcome|ACRYSOF® ReSTOR® +3.0|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
1054051|NCT00684138|O2|Outcome|ACRYSOF® ReSTOR® Aspheric +4.0|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
1054052|NCT00684138|O1|Outcome|ACRYSOF® ReSTOR® +3.0|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
1054053|NCT00684138|O2|Outcome|ACRYSOF® ReSTOR® Aspheric +4.0|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
1054058|NCT00684138|O1|Outcome|ACRYSOF® ReSTOR® +3.0|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
1054059|NCT00684138|E4|Reported Event|ACRYSOF® ReSTOR® Aspheric +4.0 (Second Eyes)|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens - Second eye implanted only
1054060|NCT00684138|E3|Reported Event|ACRYSOF® ReSTOR® +3.0 (Second Eyes)|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens - Second eye implanted only
1054061|NCT00684138|E2|Reported Event|ACRYSOF® ReSTOR® Aspheric +4.0 (First Eyes)|ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens - First eye implanted only
1054062|NCT00684138|E1|Reported Event|ACRYSOF® ReSTOR® +3.0 (First Eyes)|ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens - First eye implanted only
1054063|NCT00684073|B1|Baseline|Subutex®/Suboxone®|Subutex® for first two days of study followed by Suboxone® for last 3 days of study
1054064|NCT00684073|P1|Participant Flow|Subutex®/Suboxone®|Subutex® for first two days of study followed by Suboxone® for last 3 days of study
1054065|NCT00684073|O5|Outcome|Day 5 (Suboxone®)|All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study
1054066|NCT00684073|O4|Outcome|Day 4 (Suboxone®)|All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study
1054067|NCT00684073|O3|Outcome|Day 3 (Suboxone®)|All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study
1054068|NCT00684073|O2|Outcome|Day 2 (Subutex®)|All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study
1054069|NCT00684073|O1|Outcome|Day 1 (Subutex®)|All subjects in this trial received Subutex® for first two days of study followed by Suboxone® for last 3 days of study
1054070|NCT00684073|E1|Reported Event|Subutex®/Suboxone®|Subutex® for first two days of study followed by Suboxone® for last 3 days of study
1054071|NCT00684060|B3|Baseline|Total|Total of all reporting groups
1054072|NCT00684060|B2|Baseline|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
1054073|NCT00684060|B1|Baseline|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
1054074|NCT00684060|P2|Participant Flow|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
1054075|NCT00684060|P1|Participant Flow|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
1054076|NCT00684060|O2|Outcome|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
1054077|NCT00684060|O1|Outcome|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
1054078|NCT00684060|O2|Outcome|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
1054079|NCT00684060|O1|Outcome|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
1054080|NCT00684060|O2|Outcome|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
1054081|NCT00684060|O1|Outcome|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
1054082|NCT00684060|O2|Outcome|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
1054083|NCT00684060|O1|Outcome|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
1054084|NCT00684060|O2|Outcome|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
1054085|NCT00684060|O1|Outcome|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
1054086|NCT00684060|O2|Outcome|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
1054087|NCT00684060|O1|Outcome|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
1054088|NCT00684060|O2|Outcome|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
1054089|NCT00684060|O1|Outcome|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
1054090|NCT00684060|O2|Outcome|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
1054091|NCT00684060|O1|Outcome|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
1054092|NCT00684060|E2|Reported Event|Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
1054093|NCT00684060|E1|Reported Event|Stem Cell Arm|Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
1054094|NCT00684047|B4|Baseline|Total|Total of all reporting groups
1054095|NCT00684047|B3|Baseline|Manual Compression Primary Part (II)|Subjects treated with manual compression were analyzed.
1054096|NCT00684047|B2|Baseline|FS Grifols Primary Part (II)|Subjects treated during FS Grifols Primary Part (II) were analyzed. FS Grifols: Fibrin Sealant Grifols (FS Grifols).
1054097|NCT00684047|B1|Baseline|FS Grifols Preliminary Part (I)|Subjects treated during FS Grifols Preliminary Part (I) were analyzed. FS Grifols: Fibrin Sealant Grifols (FS Grifols).
1054098|NCT00684047|P3|Participant Flow|Manual Compression Primary Part (II)|Manual Compression was applied in subjects in this arm.
1054099|NCT00684047|P2|Participant Flow|FS Grifols Primary Part (II)|FS Grifol was applied in subjects in this arm. FS Grifols: Fibrin Sealant Grifols (FS Grifols).
1054100|NCT00684047|P1|Participant Flow|FS Grifols Preliminary Part (I)|FS Grifols was applied in all subjects in this arm. FS Grifols: Fibrin Sealant Grifols (FS Grifols).
1054101|NCT00684047|O2|Outcome|Manual Compression Primary Part (II)|Manual compression was applied during the Manual Compression Primary Part (II).
1054102|NCT00684047|O1|Outcome|FS Grifols Primary Part (II)|FS Grifols was applied during FS Grifols Primary Part (II). FS Grifols: Fibrin Sealant Grifols (FS Grifols).
1054103|NCT00684047|O2|Outcome|Manual Compression Primary Part (II)|Manual Compression was applied in subjects in this arm.
1054104|NCT00684047|O1|Outcome|FS Grifols Primary Part (II)|FS Grifol was applied in subjects. FS Grifols: Fibrin Sealant Grifols (FS Grifols).
1054105|NCT00684047|O2|Outcome|Manual Compression Primary Part (II)|Manual compression was applied during the Manual Compression Primary Part (II).
1054106|NCT00684047|O1|Outcome|FS Grifols Primary Part (II)|FS Grifols was applied during FS Grifols Primary Part (II). FS Grifols: Fibrin Sealant Grifols (FS Grifols).
1054107|NCT00684047|E2|Reported Event|Manual Compression Primary Part (II)|The safety population included all subjects treated with manual compression in the Manual Compression Primary Part (II). Five subjects randomized to this arm were treated with FS Grifols and thus were removed from this arm for the safety analyses.
1054108|NCT00684047|E1|Reported Event|FS Grifols [Pooled Preliminary Part (I) + Primary Part (II)]|"The safety population included all subjects treated with FS Grifols in Preliminary Part (I) and Primary Part (II). FS Grifols: Fibrin Sealant Grifols (FS Grifols): Preliminary Part (I): 72 subjects and Primary Part (II): 110 subjects.~The safety population included five additional subjects treated with FS Grifols instead of manual compression who were not included in the baseline and efficacy outcome analyses."
1054109|NCT00684021|B5|Baseline|Total|Total of all reporting groups
1054110|NCT00684021|B4|Baseline|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
1054111|NCT00684021|B3|Baseline|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
1054112|NCT00684021|B2|Baseline|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
1054113|NCT00684021|B1|Baseline|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
1054114|NCT00684021|P4|Participant Flow|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
1054115|NCT00684021|P3|Participant Flow|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
1054116|NCT00684021|P2|Participant Flow|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
1054117|NCT00684021|P1|Participant Flow|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
1054118|NCT00684021|O4|Outcome|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
1054119|NCT00684021|O3|Outcome|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
1054120|NCT00684021|O2|Outcome|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
1054121|NCT00684021|O1|Outcome|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
1054122|NCT00684021|O4|Outcome|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
1054123|NCT00684021|O3|Outcome|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
1054124|NCT00684021|O2|Outcome|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
1054125|NCT00684021|O1|Outcome|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
1054126|NCT00684021|O4|Outcome|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
1054127|NCT00684021|O3|Outcome|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
1054128|NCT00684021|O2|Outcome|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
1054129|NCT00684021|O1|Outcome|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
1054130|NCT00684021|O4|Outcome|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
1054131|NCT00684021|O3|Outcome|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
1054132|NCT00684021|O2|Outcome|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
1054133|NCT00684021|O1|Outcome|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
1054134|NCT00684021|O4|Outcome|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
1054135|NCT00684021|O3|Outcome|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
1054136|NCT00684021|O2|Outcome|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
1054137|NCT00684021|O1|Outcome|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
1054138|NCT00684021|O4|Outcome|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
1054139|NCT00684021|O3|Outcome|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
1054140|NCT00684021|O2|Outcome|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
1054141|NCT00684021|O1|Outcome|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
1054142|NCT00684021|O4|Outcome|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
1054143|NCT00684021|O3|Outcome|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
1054144|NCT00684021|O2|Outcome|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
1054145|NCT00684021|O1|Outcome|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
1054146|NCT00684021|O4|Outcome|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
1054147|NCT00684021|O3|Outcome|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
1054258|NCT00683826|O2|Outcome|Leucine 8 Grams|Arm number two of the study will be a dose of Leucine of 8g.
1054148|NCT00684021|O2|Outcome|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
1054149|NCT00684021|O1|Outcome|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
1054150|NCT00684021|E4|Reported Event|Day 7 Placebo Arm|Participants will receive placebo infusion (5% HSA) 7 days after PCI.
1054151|NCT00684021|E3|Reported Event|Day 7 Stem Cell Arm|Participants will receive active adult stem cell infusion 7 days after PCI.
1054152|NCT00684021|E2|Reported Event|Day 3 Placebo Arm|Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
1054153|NCT00684021|E1|Reported Event|Day 3 Stem Cell Arm|Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
1054154|NCT00683930|B4|Baseline|Total|Total of all reporting groups
1054155|NCT00683930|B3|Baseline|MMF 3 g/Day|Mycophenolate mofetil (MMF) 500 mg tablets; 6 tablets twice daily for 52 weeks
1054156|NCT00683930|B2|Baseline|MMF 2 g/Day|Mycophenolate mofetil (MMF) 500 mg tablets; 4 tablets twice daily for 52 weeks
1054157|NCT00683930|B1|Baseline|Placebo|Placebo for Mycophenolate Mofetil (MMF) 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
1054158|NCT00683930|P3|Participant Flow|MMF 3 g/Day|Mycophenolate mofetil (MMF) 500 mg tablets; 6 tablets twice daily for 52 weeks
1054159|NCT00683930|P2|Participant Flow|MMF 2 g/Day|Mycophenolate mofetil (MMF) 500 mg tablets; 4 tablets twice daily for 52 weeks
1054160|NCT00683930|P1|Participant Flow|Placebo|Placebo for Mycophenolate Mofetil (MMF) 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
1054161|NCT00683930|O4|Outcome|Mycophenolate Mofetil 3 g/Day|MMF 500 mg tablets; 6 tablets twice daily for 52 weeks
1054162|NCT00683930|O3|Outcome|Mycophenolate Mofetil 2 g/Day|MMF 500 mg tablets; 4 tablets twice daily for 52 weeks
1054163|NCT00683930|O2|Outcome|MMF 2 g/Day and MMF 3 g/Day Groups Combined|MMF 2 g/day group: 500 mg tablets, 4 tablets twice daily for 52 weeks MMF 3 g/day group: 500 mg tablets, 6 tablets twice daily for 52 weeks
1054164|NCT00683930|O1|Outcome|Placebo|Placebo for MMF 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
1054165|NCT00683930|O2|Outcome|MMF 2 g/Day and MMF 3 g/Day Groups Combined|MMF 2 g/day group: 500 mg tablets, 4 tablets twice daily for 52 weeks MMF 3 g/day group: 500 mg tablets, 6 tablets twice daily for 52 weeks
1054166|NCT00683930|O1|Outcome|Placebo|Placebo for MMF 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
1054167|NCT00683930|O2|Outcome|MMF 2 g/Day and MMF 3 g/Day Groups Combined|MMF 2 g/day group: 500 mg tablets, 4 tablets twice daily for 52 weeks MMF 3 g/day group: 500 mg tablets, 6 tablets twice daily for 52 weeks
1054168|NCT00683930|O1|Outcome|Placebo|Placebo for MMF 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
1054169|NCT00683930|O2|Outcome|MMF 2 g/Day and MMF 3 g/Day Groups Combined|MMF 2 g/day group: 500 mg tablets, 4 tablets twice daily for 52 weeks MMF 3 g/day group: 500 mg tablets, 6 tablets twice daily for 52 weeks
1054170|NCT00683930|O1|Outcome|Placebo|Placebo for MMF 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
1054171|NCT00683930|E3|Reported Event|MMF 3 g/Day|Mycophenolate mofetil (MMF) 500 mg tablets; 6 tablets twice daily for 52 weeks
1054172|NCT00683930|E2|Reported Event|MMF 2 g/Day|Mycophenolate mofetil (MMF) 500 mg tablets; 4 tablets twice daily for 52 weeks
1054173|NCT00683930|E1|Reported Event|Placebo|Placebo for Mycophenolate Mofetil (MMF) 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
1054174|NCT00683917|B4|Baseline|Total|Total of all reporting groups
1054175|NCT00683917|B3|Baseline|Lupron|Lupron Depot: Lupron 3.75 mg monthly intramuscular injections for 4 months
1054176|NCT00683917|B2|Baseline|Proellex 50 mg|Proellex 50 mg: Proellex 50 mg, 2 capsules daily for 4 months
1054177|NCT00683917|B1|Baseline|Proellex 25 mg|Proellex 25 mg: Proellex 25 mg, 1 capsule daily for 4 months
1054178|NCT00683917|P1|Participant Flow|Proellex All Groups|Proellex 25 mg: Proellex 50 mg, placebo, 1 capsule daily for 4 months Study prematurely terminated, no further data available
1054179|NCT00683917|O3|Outcome|Lupron|Lupron Depot: Lupron 3.75 mg monthly intramuscular injections for 4 months
1054180|NCT00683917|O2|Outcome|Proellex 50 mg|Proellex 50 mg: Proellex 50 mg, 2 capsules daily for 4 months
1054181|NCT00683917|O1|Outcome|Proellex 25 mg|Proellex 25 mg: Proellex 25 mg, 1 capsule daily for 4 months
1054182|NCT00683917|E3|Reported Event|Lupron|Lupron Depot: Lupron 3.75 mg monthly intramuscular injections for 4 months
1054183|NCT00683917|E2|Reported Event|Proellex 50 mg|Proellex 50 mg: Proellex 50 mg, 2 capsules daily for 4 months
1054184|NCT00683917|E1|Reported Event|Proellex 25 mg|Proellex 25 mg: Proellex 25 mg, 1 capsule daily for 4 months
1054185|NCT00683904|B3|Baseline|Total|Total of all reporting groups
1054186|NCT00683904|B2|Baseline|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
1054187|NCT00683904|B1|Baseline|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
1054188|NCT00683904|P2|Participant Flow|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|After all participants in Dose Level 1 have been observed for 1 full 21-day cycle, Dose Level 2 opened: Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL. infused over 30 minutes on Day 1 of each 21-day cycle.
1054189|NCT00683904|P1|Participant Flow|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
1054190|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
1054191|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
1054192|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
1054193|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
1054194|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
1054195|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
1054196|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
1054197|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
1054198|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
1054199|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
1054200|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
1054201|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
1054202|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
1054203|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
1054204|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
1054205|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
1054206|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
1054207|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
1054208|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
1054209|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
1054210|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
1054211|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
1054212|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
1054213|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
1054214|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
1054215|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle.
1054216|NCT00683904|O1|Outcome|All Treated|All subjects who received at least 1 dose of either ixabepilone or carboplatin
1054217|NCT00683904|O2|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
1054259|NCT00683826|O1|Outcome|Leucine 4 Grams|This will be a triple arm design where subjects will be randomized into three groups. Arm #1 will be 4g of Leucine.
1054218|NCT00683904|O1|Outcome|Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
1054219|NCT00683904|E2|Reported Event|Ixabepilone, 32 mg/m2 + Carboplatin 6 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
1054220|NCT00683904|E1|Reported Event|Ixabepilone, 32 mg/m2 + Carboplatin 5 mg/Min/mL|Ixabepilone, 32 mg/m^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
1054221|NCT00683878|B4|Baseline|Total|Total of all reporting groups
1054222|NCT00683878|B3|Baseline|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
1054223|NCT00683878|B2|Baseline|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
1054224|NCT00683878|B1|Baseline|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
1054225|NCT00683878|P3|Participant Flow|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
1054226|NCT00683878|P2|Participant Flow|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
1054227|NCT00683878|P1|Participant Flow|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
1054228|NCT00683878|O3|Outcome|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
1054229|NCT00683878|O2|Outcome|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
1054230|NCT00683878|O1|Outcome|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
1054231|NCT00683878|O3|Outcome|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
1054232|NCT00683878|O2|Outcome|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
1054233|NCT00683878|O1|Outcome|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
1054234|NCT00683878|O3|Outcome|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
1054235|NCT00683878|O2|Outcome|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
1054236|NCT00683878|O1|Outcome|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
1054237|NCT00683878|O3|Outcome|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
1054238|NCT00683878|O2|Outcome|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
1054239|NCT00683878|O1|Outcome|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
1054240|NCT00683878|O3|Outcome|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
1054241|NCT00683878|O2|Outcome|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
1054242|NCT00683878|O1|Outcome|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
1054243|NCT00683878|O3|Outcome|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
1054244|NCT00683878|O2|Outcome|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
1054245|NCT00683878|O1|Outcome|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
1054246|NCT00683878|O3|Outcome|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
1054247|NCT00683878|O2|Outcome|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
1054248|NCT00683878|O1|Outcome|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
1054249|NCT00683878|E3|Reported Event|Dapagliflozin 10MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
1054250|NCT00683878|E2|Reported Event|Dapagliflozin 5MG + Pioglitazone|Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
1054251|NCT00683878|E1|Reported Event|PLACEBO + Pioglitazone|Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
1054252|NCT00683826|B4|Baseline|Total|Total of all reporting groups
1054253|NCT00683826|B3|Baseline|Leucine 0 Grams-control|Initial intervention.
1054254|NCT00683826|B2|Baseline|Leucine 8 Grams|Initial intervention.
1054255|NCT00683826|B1|Baseline|Leucine 4 Grams|Initial intervention.
1054256|NCT00683826|P1|Participant Flow|All Study Participants|This will be a three-way crossover design, where subjects will be randomized into three groups. All subjects will receive all interventions (0g leucine, 4g leucine, 8g leucine) in a randomized order.
1054257|NCT00683826|O3|Outcome|Leucine 0 Grams-control|The third arm of the study will be composed of a control drink with no leucine in it.
1054260|NCT00683826|E3|Reported Event|Leucine 0 Grams-control|The third arm of the study will be composed of a control drink with no leucine in it.
1054261|NCT00683826|E2|Reported Event|Leucine 8 Grams|Arm number two of the study will be a dose of Leucine of 8g.
1054262|NCT00683826|E1|Reported Event|Leucine 4 Grams|This will be a triple arm design where subjects will be randomized into three groups. Arm #1 will be 4g of Leucine.
1054263|NCT00683800|B3|Baseline|Total|Total of all reporting groups
1054264|NCT00683800|B2|Baseline|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
1054265|NCT00683800|B1|Baseline|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
1054266|NCT00683800|P2|Participant Flow|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
1054267|NCT00683800|P1|Participant Flow|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
1054268|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
1054269|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
1054270|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
1054271|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
1054272|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
1054273|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
1054274|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
1054275|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
1054276|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
1054277|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
1054278|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
1054279|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
1054280|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
1054281|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
1054282|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
1054283|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
1054284|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
1054285|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
1054286|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
1054287|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
1054288|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
1054289|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
1054290|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
1054291|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
1054292|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
1054293|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
1054294|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
1054295|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
1054296|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
1054297|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
1054298|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
1054299|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
1054300|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
1054301|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
1054302|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
1054303|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
1054304|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
1054305|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
1054306|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
1054307|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
1054308|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
1054309|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
1054311|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
1054312|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
1054313|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
1054314|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
1054315|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
1054316|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
1054317|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
1054318|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
1054319|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
1054320|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
1054321|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
1054322|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
1054323|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
1054324|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
1054325|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
1054326|NCT00683800|O2|Outcome|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
1054327|NCT00683800|O1|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
1054328|NCT00683800|E2|Reported Event|Placebo|Matching placebo tablets daily until Day 365 or early withdrawal.
1054329|NCT00683800|E1|Reported Event|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligram (mg) tablets daily until Day 365 or early withdrawal.
1054330|NCT00683787|B4|Baseline|Total|Total of all reporting groups
1054331|NCT00683787|B3|Baseline|Arm C: Docetaxel+VANDETANIB (300 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
1054332|NCT00683787|B2|Baseline|Arm B: Docetaxel+VANDETANIB (100 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
1054333|NCT00683787|B1|Baseline|Arm A: Docetaxel|"Patients receive docetaxel IV once every 3 weeks.~docetaxel: Given IV once every 3 weeks"
1054334|NCT00683787|P3|Participant Flow|Arm C: Docetaxel+VANDETANIB (300 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
1054335|NCT00683787|P2|Participant Flow|Arm B: Docetaxel+VANDETANIB (100 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
1054336|NCT00683787|P1|Participant Flow|Arm A: Docetaxel|"Patients receive docetaxel IV once every 3 weeks.~docetaxel: Given IV once every 3 weeks"
1054337|NCT00683787|O3|Outcome|Arm C: Docetaxel+VANDETANIB (300 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
1054338|NCT00683787|O2|Outcome|Arm B: Docetaxel+VANDETANIB (100 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
1054339|NCT00683787|O1|Outcome|Arm A: Docetaxel|"Patients receive docetaxel IV once every 3 weeks.~docetaxel: Given IV once every 3 weeks"
1054340|NCT00683787|O3|Outcome|Arm C: Docetaxel+VANDETANIB (300 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
1054341|NCT00683787|O2|Outcome|Arm B: Docetaxel+VANDETANIB (100 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
1054342|NCT00683787|O1|Outcome|Arm A: Docetaxel|"Patients receive docetaxel IV once every 3 weeks.~docetaxel: Given IV once every 3 weeks"
1054343|NCT00683787|O3|Outcome|Arm C: Docetaxel+VANDETANIB (300 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
1054344|NCT00683787|O2|Outcome|Arm B: Docetaxel+VANDETANIB (100 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
1054345|NCT00683787|O1|Outcome|Arm A: Docetaxel|"Patients receive docetaxel IV once every 3 weeks.~docetaxel: Given IV once every 3 weeks"
1054346|NCT00683787|O3|Outcome|Arm C: Docetaxel+VANDETANIB (300 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
1054347|NCT00683787|O2|Outcome|Arm B: Docetaxel+VANDETANIB (100 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
1054348|NCT00683787|O1|Outcome|Arm A: Docetaxel|"Patients receive docetaxel IV once every 3 weeks.~docetaxel: Given IV once every 3 weeks"
1054349|NCT00683787|E3|Reported Event|Arm C: Docetaxel+VANDETANIB (300 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
1054350|NCT00683787|E2|Reported Event|Arm B: Docetaxel+VANDETANIB (100 mg)|"Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.~docetaxel: Given IV once every 3 weeks~vandetanib: Oral vandetanib once daily"
1054351|NCT00683787|E1|Reported Event|Arm A: Docetaxel|"Patients receive docetaxel IV once every 3 weeks.~docetaxel: Given IV once every 3 weeks"
1054353|NCT00683774|B2|Baseline|Normal Subjects|"Normal subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
1054354|NCT00683774|B1|Baseline|PCOS Subjects|"PCOS subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
1054355|NCT00683774|P2|Participant Flow|Normal Subjects|"Normal subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
1054356|NCT00683774|P1|Participant Flow|PCOS Subjects|"PCOS subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
1054357|NCT00683774|O2|Outcome|Normal Subjects|"Normal subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
1054358|NCT00683774|O1|Outcome|PCOS Subjects|"PCOS subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
1054359|NCT00683774|O2|Outcome|Normal Subjects|"Normal subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
1054360|NCT00683774|O1|Outcome|PCOS Subjects|"PCOS subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
1054361|NCT00683774|E2|Reported Event|Normal Subjects|"Normal subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
1054362|NCT00683774|E1|Reported Event|PCOS Subjects|"PCOS subjects given diazoxide~diazoxide: 100mg orally three times per day for 10 days"
1054363|NCT00683696|B3|Baseline|Total|Total of all reporting groups
1054364|NCT00683696|B2|Baseline|CRT=OFF|Cardiac Resynchronization Therapy deactivated.
1054365|NCT00683696|B1|Baseline|CRT=ON|Cardiac Resynchronization Therapy activated.
1054366|NCT00683696|P2|Participant Flow|CRT=OFF|"Cardiac Resynchronization Therapy deactivated.~Subject implanted with BIOTRONIK Lumax HF-T CRT-D system with ICD back-up enabled and randomized to CRT=OFF."
1054367|NCT00683696|P1|Participant Flow|CRT=ON|"Cardiac Resynchronization Therapy activated.~Subject implanted with BIOTRONIK Lumax HF-T CRT-D system with ICD back-up enabled and randomized to CRT=ON."
1054368|NCT00683696|O1|Outcome|Subjects That Underwent an Implant Attempt|
1054369|NCT00683696|O2|Outcome|CRT=OFF|Cardiac Resynchronization Therapy deactivated.
1054370|NCT00683696|O1|Outcome|CRT=ON|Cardiac Resynchronization Therapy activated.
1054371|NCT00683696|E2|Reported Event|CRT=OFF|Cardiac Resynchronization Therapy deactivated.
1054372|NCT00683696|E1|Reported Event|CRT=ON|Cardiac Resynchronization Therapy activated.
1054373|NCT00683657|B3|Baseline|Total|Total of all reporting groups
1054374|NCT00683657|B2|Baseline|Placebo + Metformin|Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
1054375|NCT00683657|B1|Baseline|Saxagliptin 5 mg + Metformin|Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
1054376|NCT00683657|P2|Participant Flow|Placebo + Metformin|Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
1054377|NCT00683657|P1|Participant Flow|Saxagliptin 5 mg + Metformin|Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
1054378|NCT00683657|O2|Outcome|Placebo + Metformin|Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
1054379|NCT00683657|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
1054380|NCT00683657|O2|Outcome|Placebo + Metformin|Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
1054381|NCT00683657|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
1054382|NCT00683657|O2|Outcome|Placebo + Metformin|Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
1054383|NCT00683657|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
1054384|NCT00683657|O2|Outcome|Placebo + Metformin|Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
1054385|NCT00683657|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
1054386|NCT00683657|O2|Outcome|Placebo + Metformin|Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.
1054387|NCT00683657|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.
1054388|NCT00683657|E2|Reported Event|SAXA 5MG + MET|
1054389|NCT00683657|E1|Reported Event|PLACEBO + MET|
1054390|NCT00683618|B4|Baseline|Total|Total of all reporting groups
1054391|NCT00683618|B3|Baseline|Atorvastatin 10mg|Taken orally once daily
1054392|NCT00683618|B2|Baseline|Rosuvastatin 10mg|Taken orally once daily
1054393|NCT00683618|B1|Baseline|Rosuvastatin 5mg|Taken orally once daily
1054394|NCT00683618|P3|Participant Flow|Atorvastatin 10mg|Taken orally once daily
1054395|NCT00683618|P2|Participant Flow|Rosuvastatin 10mg|Taken orally once daily
1054396|NCT00683618|P1|Participant Flow|Rosuvastatin 5mg|Taken orally once daily
1054397|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
1054398|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
1054399|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
1054400|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
1054401|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
1054402|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
1054403|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
1054404|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
1054405|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
1054406|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
1054407|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
1054408|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
1054409|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
1054410|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
1054411|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
1054412|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
1054413|NCT00683618|O2|Outcome|Rosuvastatin 10mg|Taken orally once daily
1054414|NCT00683618|O1|Outcome|Rosuvastatin 5mg|Taken orally once daily
1054415|NCT00683618|O3|Outcome|Atorvastatin 10mg|Taken orally once daily
1054441|NCT00683618|E2|Reported Event|Rosuvastatin 10mg|Taken orally once daily
1054442|NCT00683618|E1|Reported Event|Rosuvastatin 5mg|Taken orally once daily
1054443|NCT00683592|B3|Baseline|Total|Total of all reporting groups
1054444|NCT00683592|B2|Baseline|Placebo (ITT Population)|placebo to match vilazodone
1054445|NCT00683592|B1|Baseline|Vilazodone (ITT Population)|Vilazodone, 40 mg
1054446|NCT00683592|P2|Participant Flow|Placebo|Placebo to match vilazodone. Two tablets per day.
1054447|NCT00683592|P1|Participant Flow|Vilazodone|Vilazodone titrated to 40mg. Two tablets per day.
1054448|NCT00683592|O2|Outcome|Placebo (ITT Population)|placebo to match vilazodone
1054449|NCT00683592|O1|Outcome|Vilazodone (ITT Population)|Vilazodone, 40 mg
1054450|NCT00683592|O2|Outcome|Placebo (ITT Population)|placebo to match vilazodone
1054451|NCT00683592|O1|Outcome|Vilazodone (ITT Population)|Vilazodone, 40 mg
1054452|NCT00683592|O2|Outcome|Placebo (ITT Population)|placebo to match vilazodone
1054453|NCT00683592|O1|Outcome|Vilazodone (ITT Population)|Vilazodone, 40 mg
1054454|NCT00683592|O2|Outcome|Placebo (ITT Population)|placebo to match vilazodone
1054455|NCT00683592|O1|Outcome|Vilazodone (ITT Population)|Vilazodone, 40 mg
1054456|NCT00683592|O2|Outcome|Placebo (ITT Population)|placebo to match vilazodone
1054457|NCT00683592|O1|Outcome|Vilazodone (ITT Population)|Vilazodone, 40 mg
1054458|NCT00683592|O2|Outcome|Placebo (ITT Population)|placebo to match vilazodone
1054459|NCT00683592|O1|Outcome|Vilazodone (ITT Population)|Vilazodone, 40 mg
1054460|NCT00683592|E2|Reported Event|Placebo (Safety Population)|placebo to match vilazodone
1054461|NCT00683592|E1|Reported Event|Vilazodone (Safety Population)|Vilazodone, 40mg
1054462|NCT00683475|B3|Baseline|Total|Total of all reporting groups
1054463|NCT00683475|B2|Baseline|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
1054464|NCT00683475|B1|Baseline|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
1054465|NCT00683475|P2|Participant Flow|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
1054466|NCT00683475|P1|Participant Flow|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
1054467|NCT00683475|O1|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
1054468|NCT00683475|O1|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
1054469|NCT00683475|O1|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
1054470|NCT00683475|O1|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
1054471|NCT00683475|O1|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
1054472|NCT00683475|O1|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
1054473|NCT00683475|O1|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
1054474|NCT00683475|O1|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
1054475|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
1054585|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
1054476|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
1054477|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
1054478|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
1054479|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
1054480|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
1054481|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
1054482|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
1054483|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
1054484|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
1054485|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
1054486|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
1054487|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
1054488|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
1054489|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
1054490|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
1054491|NCT00683475|O2|Outcome|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
1054492|NCT00683475|O1|Outcome|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
1054493|NCT00683475|E2|Reported Event|IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone|IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
1054494|NCT00683475|E1|Reported Event|IMC-A12 + Mitoxantrone + Prednisone|IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle.
1054495|NCT00683449|B6|Baseline|Total|Total of all reporting groups
1054496|NCT00683449|B5|Baseline|1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes|Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
1054497|NCT00683449|B4|Baseline|450 μg MN-221 i.v. for 15 Minutes|30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
1054498|NCT00683449|B3|Baseline|1,000-1,080 μg MN-221 i.v.|16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
1054499|NCT00683449|B2|Baseline|MN-221 Placebo i.v. Infusion|"MN-221 Placebo i.v. infusion. Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject’s signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.~Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator."
1054500|NCT00683449|B1|Baseline|240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes|"Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:~Assessment of subject’s signs and symptoms~Completion of a dyspnea index scale~Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%~Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subj"
1054501|NCT00683449|P5|Participant Flow|1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes|Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
1054502|NCT00683449|P4|Participant Flow|450 μg MN-221 i.v. for 15 Minutes|30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
1054503|NCT00683449|P3|Participant Flow|1,000-1,080 μg MN-221 i.v.|16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
1054504|NCT00683449|P2|Participant Flow|MN-221 Placebo i.v. Infusion|"MN-221 Placebo i.v. infusion. Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject’s signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.~Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator."
1054505|NCT00683449|P1|Participant Flow|240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes|"Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:~Assessment of subject’s signs and symptoms~Completion of a dyspnea index scale~Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%~Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subj"
1054506|NCT00683449|O5|Outcome|1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes|Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
1054507|NCT00683449|O4|Outcome|450 μg MN-221 i.v. for 15 Minutes|30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
1054508|NCT00683449|O3|Outcome|1,000-1,080 μg MN-221 i.v.|16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
1054551|NCT00683163|B1|Baseline|Concurrent (A)|Concurrent Group (A) received 6 months of monthly oral ibandronate 150 mg plus daily PTH 1-84 1.4 mg, followed by 18 months of ibandronate only. Placebo injections were given months 13-15.
1054509|NCT00683449|O2|Outcome|MN-221 Placebo i.v. Infusion|"MN-221 Placebo i.v. infusion. Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject’s signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.~Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator."
1054510|NCT00683449|O1|Outcome|240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes|"Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:~Assessment of subject’s signs and symptoms~Completion of a dyspnea index scale~Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%~Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subj"
1054511|NCT00683449|O5|Outcome|1,995 MN-221 Administered i.v. for 15 Minutes and 25 Minutes|One subject that was randomized to receive 450 MN-221 intravenously for 15 minutes was administered 1995 micrograms. Another subject that was randomized to receive 450 micrograms for 15 minutes actually received a dose of 1995 micrograms MN-221 intravenously for 25 minutes.
1054512|NCT00683449|O4|Outcome|1,000-1,080 μg MN-221 Given i.v. for 15 Minutes|The Data Safety Monitoring Board recommended that subjects can receive MN-221 at 16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose 1000-1080 μg).
1054513|NCT00683449|O3|Outcome|450 μg MN-221 Given i.v.|The Data Safety Monitoring Board convened and recommended that the next highest scheduled can be administered to subjects. They received MN-221 at 30 μg/minute for 15 minutes (total dose 450 μg).
1054514|NCT00683449|O2|Outcome|Placebo Administered Intravenously|Initial dose group received MN-221 placebo intravenously for 15 minutes. For a subsequent dose group that was scheduled for a longer intravenous infusion of the study drug, subjects received MN-221 placebo intravenously for 15 minutes followed by MN-221 intravenously for 105 minutes.
1054515|NCT00683449|O1|Outcome|MN-221 at 16.0 μg/Min for 15 Min (Total 240 μg)|The dosing scheme that consisted of a 15-minute infusion was based on PK (pharmacokinetic) modeling performed using data from the previous MN-221 studies that enrolled either healthy volunteers or subjects with stable mild to moderate asthma.
1054516|NCT00683449|O5|Outcome|1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes|Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
1054517|NCT00683449|O4|Outcome|450 μg MN-221 i.v. for 15 Minutes|30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
1054518|NCT00683449|O3|Outcome|1,000-1,080 μg MN-221 i.v.|16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
1054519|NCT00683449|O2|Outcome|MN-221 Placebo i.v. Infusion|"MN-221 Placebo i.v. infusion. Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject’s signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.~Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator."
1054520|NCT00683449|O1|Outcome|240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes|"Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:~Assessment of subject’s signs and symptoms~Completion of a dyspnea index scale~Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%~Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subj"
1054521|NCT00683449|E5|Reported Event|1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes|Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
1054522|NCT00683449|E4|Reported Event|450 μg MN-221 i.v. for 15 Minutes|30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
1054550|NCT00683163|B2|Baseline|Sequential (B)|Sequential Group (B) received 3 months of daily PTH 1-84 1.4 mg followed by 9 months of monthly oral ibandronate 150 mg in each of years 1 and 2. Placebo monthly pills were given months 1-3 and months 13-15, and placebo injections were given months 4-6.
1057434|NCT00674765|E2|Reported Event|Placebo|"Placebo~Placebo: 400 mg/day"
1054523|NCT00683449|E3|Reported Event|1,000-1,080 μg MN-221 i.v.|16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
1054524|NCT00683449|E2|Reported Event|MN-221 Placebo i.v. Infusion|"MN-221 Placebo i.v. infusion. Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject’s signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.~Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator."
1054525|NCT00683449|E1|Reported Event|240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes|"Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject’s FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:~Assessment of subject’s signs and symptoms~Completion of a dyspnea index scale~Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%~Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.~Spirometry completed within 10 minutes of nebulizer treatments, followed by~Reassessment of signs and symptoms. If the subj"
1054526|NCT00683410|B1|Baseline|Prevenar 7v|Pneumococcal conjugate vaccine, 7-valent, 0.5 mL intramuscular injection
1054527|NCT00683410|P1|Participant Flow|Prevenar 7v|Pneumococcal conjugate vaccine, 7-valent, 0.5 mL intramuscular injection
1054528|NCT00683410|O1|Outcome|Prevenar 7v|Pneumococcal conjugate vaccine, 7-valent, 0.5 mL intramuscular injection
1054529|NCT00683410|E1|Reported Event|Prevenar 7v|Pneumococcal conjugate vaccine, 7-valent, 0.5 mL intramuscular injection
1054530|NCT00683384|B1|Baseline|Etanercept|Etanercept (Enbrel) 25 mg by subcutaneous injection
1054531|NCT00683384|P1|Participant Flow|Etanercept|Etanercept (Enbrel) 25 mg by subcutaneous injection
1054532|NCT00683384|O1|Outcome|Etanercept|Etanercept (Enbrel) 25 mg by subcutaneous injection
1054533|NCT00683384|E1|Reported Event|Etanercept|Etanercept (Enbrel) 25 mg by subcutaneous injection
1054534|NCT00683332|B1|Baseline|Tygacil 50 mg|Filipino participants received at least 1 intravenous (IV) dose of tygacil 50 mg administered per registered indication as stated in the product label/insert
1054535|NCT00683332|P1|Participant Flow|Tygacil 50 mg|Filipino participants received at least 1 intravenous (IV) dose of tygacil 50 mg administered per registered indication as stated in the product label/insert
1054536|NCT00683332|O1|Outcome|Tygacil 50 mg|Filipino participants received at least 1 intravenous (IV) dose of tygacil 50 mg administered per registered indication as stated in the product label/insert
1054537|NCT00683332|E1|Reported Event|Tygacil 50 mg|Filipino participants received at least 1 intravenous (IV) dose of tygacil 50 mg administered per registered indication as stated in the product label/insert
1054538|NCT00683293|B3|Baseline|Total|Total of all reporting groups
1054539|NCT00683293|B2|Baseline|2 Robot-assisted Laparoscopic Hysterectomy|group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization
1054540|NCT00683293|B1|Baseline|1 Conventional Laparoscopic Hysterectomy|"Randomized group of patients receiving conventional laparoscopic hysterectomy~Conventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques"
1054541|NCT00683293|P2|Participant Flow|2 Robot-assisted Laparoscopic Hysterectomy|group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization
1054542|NCT00683293|P1|Participant Flow|1 Conventional Laparoscopic Hysterectomy|"Randomized group of patients receiving conventional laparoscopic hysterectomy~Conventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques"
1054543|NCT00683293|O2|Outcome|2 Robot-assisted Laparoscopic Hysterectomy|group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization
1054544|NCT00683293|O1|Outcome|1 Conventional Laparoscopic Hysterectomy|"Randomized group of patients receiving conventional laparoscopic hysterectomy~Conventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques"
1054545|NCT00683293|O2|Outcome|2 Robot-assisted Laparoscopic Hysterectomy|group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization
1054546|NCT00683293|O1|Outcome|1 Conventional Laparoscopic Hysterectomy|"Randomized group of patients receiving conventional laparoscopic hysterectomy~Conventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques"
1054547|NCT00683293|E2|Reported Event|2 Robot-assisted Laparoscopic Hysterectomy|group of patients that receied robot-assisted laparoscopic hysterectomy Robot-assisted (Da Vinci®) laparoscopic hysterectomy : Removal of uterus by robot-assisted laparoscopic technique after randomization
1054548|NCT00683293|E1|Reported Event|1 Conventional Laparoscopic Hysterectomy|"Randomized group of patients receiving conventional laparoscopic hysterectomy~Conventional Laparoscopic Hysterectomy : Removal of uterus via standard laparoscopic techniques"
1054549|NCT00683163|B3|Baseline|Total|Total of all reporting groups
1054552|NCT00683163|P2|Participant Flow|Sequential (B)|Sequential Group (B) received 3 months of daily PTH 1-84 1.4 mg followed by 9 months of monthly oral ibandronate 150 mg in each of years 1 and 2. Placebo monthly pills were given months 1-3 and months 13-15, and placebo injections were given months 4-6.
1054553|NCT00683163|P1|Participant Flow|Concurrent (A)|Concurrent Group (A) received 6 months of monthly oral ibandronate 150 mg plus daily parathyroid hormone (PTH) 1-84 1.4 mg, followed by 18 months of ibandronate only. Placebo injections were given months 13-15.
1054554|NCT00683163|O2|Outcome|Sequential (B)|The Sequential Group (B) received 3 months of daily PTH 1-84 1.4 mg, followed by 9 months of monthly oral ibandronate 150 mg in year 1 and again in year 2. Placebo monthly pills were given months 1-3 and months 13-15, and placebo injections were given months 4-6.
1054555|NCT00683163|O1|Outcome|Concurrent (A)|The Concurrent Group (A) received 6 months of monthly oral ibandronate 150 mg plus daily PTH 1-84 1.4 mg, followed by 18 months of ibandronate only. Placebo injections were given months 13-15.
1054556|NCT00683163|O2|Outcome|Sequential (B)|The Sequential Group (B) received 3 months of daily PTH 1-84 1.4 mg, followed by 9 months of monthly oral ibandronate 150 mg in year 1 and again in year 2. Placebo monthly pills were given months 1-3 and months 13-15, and placebo injections were given months 4-6.
1054557|NCT00683163|O1|Outcome|Concurrent (A)|The Concurrent Group (A) received 6 months of monthly oral ibandronate 150 mg plus daily PTH 1-84 1.4 mg, followed by 18 months of ibandronate only. Placebo injections were given months 13-15.
1054558|NCT00683163|E2|Reported Event|Sequential (B)|Sequential Group (B) received 3 months of daily PTH 1-84 1.4 mg followed by 9 months of monthly oral ibandronate 150 mg in each of years 1 and 2. Placebo monthly pills were given months 1-3 and months 13-15, and placebo injections were given months 4-6.
1054559|NCT00683163|E1|Reported Event|Concurrent (A)|Concurrent Group (A) received 6 months of monthly oral ibandronate 150 mg plus daily PTH 1-84 1.4 mg, followed by 18 months of ibandronate only. Placebo injections were given months 13-15.
1054560|NCT00683085|B1|Baseline|Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine|HLA-A*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m^2 of body surface area
1054561|NCT00683085|P1|Participant Flow|Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine|HLA-A*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m^2 of body surface area
1054562|NCT00683085|O1|Outcome|Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine|HLA-A*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m^2 of body surface area
1054563|NCT00683085|O1|Outcome|Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine|HLA-A*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m^2 of body surface area
1054564|NCT00683085|E1|Reported Event|Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine|HLA-A*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m^2 of body surface area
1054565|NCT00683046|B1|Baseline|T-cell Depleted Allogeneic Stem Cell Transplantation|"All patients were administered the following drugs;~Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3~Melphalan 140mg/m2 IV on day -2~Stem cell infusion on day 0~Campath 20mg IV on day -7,-6,-5,-4, and -3"
1054566|NCT00683046|P1|Participant Flow|T-cell Depleted Allogeneic Stem Cell Transplantation|"All patients were administered the following drugs;~Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3~Melphalan 140mg/m2 IV on day -2~Stem cell infusion on day 0~Campath 20mg IV on day -7,-6,-5,-4, and -3"
1054567|NCT00683046|O1|Outcome|T-cell Depleted Allogeneic Stem Cell Transplantation|"All patients were administered the following drugs;~Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3~Melphalan 140mg/m2 IV on day -2~Stem cell infusion on day 0~Campath 20mg IV on day -7,-6,-5,-4, and -3"
1054568|NCT00683046|O1|Outcome|T-cell Depleted Allogeneic Stem Cell Transplantation|"All patients were administered the following drugs;~Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3~Melphalan 140mg/m2 IV on day -2~Stem cell infusion on day 0~Campath 20mg IV on day -7,-6,-5,-4, and -3"
1054569|NCT00683046|E1|Reported Event|T-cell Depleted Allogeneic Stem Cell Transplantation|"All patients were administered the following drugs;~Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3~Melphalan 140mg/m2 IV on day -2~Stem cell infusion on day 0~Campath 20mg IV on day -7,-6,-5,-4, and -3"
1054570|NCT00683020|B3|Baseline|Total|Total of all reporting groups
1054571|NCT00683020|B2|Baseline|WAIT LIST Control|WAIT LIST Control: six month Wait List.
1054572|NCT00683020|B1|Baseline|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
1054573|NCT00683020|P2|Participant Flow|WAIT LIST Control|WAIT LIST Control: six month Wait List.
1054574|NCT00683020|P1|Participant Flow|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
1054575|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
1054576|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
1054577|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
1054578|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
1054579|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
1054580|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
1054581|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
1054582|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
1054583|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
1054584|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
1054586|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
1054587|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
1054588|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
1054589|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
1054590|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
1054591|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
1054592|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
1054593|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
1054594|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
1054595|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
1054596|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
1054597|NCT00683020|O2|Outcome|WAIT LIST Control|WAIT LIST Control: six month Wait List.
1054598|NCT00683020|O1|Outcome|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
1054599|NCT00683020|E2|Reported Event|WAIT LIST Control|WAIT LIST Control: six month Wait List.
1054600|NCT00683020|E1|Reported Event|ATSM Intervention|ATSM Intervention: Automated Telephone Self-Management Support.
1054601|NCT00682890|B3|Baseline|Total|Total of all reporting groups
1054602|NCT00682890|B2|Baseline|Metformin|metformin 2000 mg and birth control pill daily
1054603|NCT00682890|B1|Baseline|Placebo|Placebo tablet and birth control pill daily
1054604|NCT00682890|P2|Participant Flow|Metformin|metformin 2000 mg and birth control pill daily
1054605|NCT00682890|P1|Participant Flow|Placebo|Placebo tablet and birth control pill daily
1054606|NCT00682890|O2|Outcome|Metformin|metformin 2000 mg and birth control pill daily
1054607|NCT00682890|O1|Outcome|Placebo|Placebo tablet and birth control pill daily
1054608|NCT00682890|O2|Outcome|Metformin|metformin 2000 mg and birth control pill daily
1054609|NCT00682890|O1|Outcome|Placebo|Placebo tablet and birth control pill daily
1054610|NCT00682890|E2|Reported Event|Metformin|metformin 2000 mg and birth control pill daily
1054611|NCT00682890|E1|Reported Event|Placebo|Placebo tablet and birth control pill daily
1054612|NCT00682851|B3|Baseline|Total|Total of all reporting groups
1054613|NCT00682851|B2|Baseline|Asymptomatic|Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
1054614|NCT00682851|B1|Baseline|Symptomatic|Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
1054615|NCT00682851|P2|Participant Flow|Asymptomatic|Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
1054616|NCT00682851|P1|Participant Flow|Symptomatic|Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
1054617|NCT00682851|O2|Outcome|Asymptomatic|Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
1054618|NCT00682851|O1|Outcome|Symptomatic|Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
1054619|NCT00682851|O2|Outcome|Asymptomatic|Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
1054620|NCT00682851|O1|Outcome|Symptomatic|Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
1054621|NCT00682851|O2|Outcome|Asymptomatic|Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
1054622|NCT00682851|O1|Outcome|Symptomatic|Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
1054623|NCT00682851|O2|Outcome|Asymptomatic|Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
1054624|NCT00682851|O1|Outcome|Symptomatic|Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
1054625|NCT00682851|E2|Reported Event|Asymptomatic|Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).
1054626|NCT00682851|E1|Reported Event|Symptomatic|Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
1054627|NCT00682838|B5|Baseline|Total|Total of all reporting groups
1054628|NCT00682838|B4|Baseline|Usual Care|Usual care- control group
1054629|NCT00682838|B3|Baseline|SM+TC|"1+2~Self-management: Self-management~Telemonitored care: Telemonitored care"
1054630|NCT00682838|B2|Baseline|Telemonitored Care|"Active Comparator~Telemonitored care: Telemonitored care"
1054631|NCT00682838|B1|Baseline|Self-management|"Active Intervention~Self-management: Self-management"
1054632|NCT00682838|P4|Participant Flow|Usual Care|Usual care- control group
1054633|NCT00682838|P3|Participant Flow|SM + TC|"1+2~Self-management: Self-management~Telemonitored care: Telemonitored care~Combination of both SM + TC intervention"
1055175|NCT00679172|O2|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1054634|NCT00682838|P2|Participant Flow|Telemonitored Care (TC)|"Active Comparator~Telemonitored care: Telemonitored care Consists of CPAP therapist actively monitoring care at a distance, and acting on that data per a set protocol"
1054635|NCT00682838|P1|Participant Flow|Self-Management (SM)|"Active Intervention~Self-management: Self-management Educational component focused on sleep apnea and CPAP from a self-management perspective"
1054636|NCT00682838|O4|Outcome|Usual Care|Usual care- control group
1054637|NCT00682838|O3|Outcome|SM+TC|"1+2~Self-management: Self-management~Telemonitored care: Telemonitored care"
1054638|NCT00682838|O2|Outcome|Telemonitored Care|"Active Comparator~Telemonitored care: Telemonitored care"
1054639|NCT00682838|O1|Outcome|Self-management|"Active Intervention~Self-management: Self-management"
1054640|NCT00682838|E4|Reported Event|Usual Care|Control Group
1054641|NCT00682838|E3|Reported Event|SM+TC|"1+2~Self-management: Self-management~Telemonitored care: Telemonitored care"
1054642|NCT00682838|E2|Reported Event|Telemonitored Care|"Active Comparator~Telemonitored care: Telemonitored care"
1054643|NCT00682838|E1|Reported Event|Self-management|"Active Intervention~Self-management: Self-management"
1054644|NCT00682786|B3|Baseline|Total|Total of all reporting groups
1054645|NCT00682786|B2|Baseline|Poor Risk (TYMS*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
1054646|NCT00682786|B1|Baseline|Good Risk (TYMS*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
1054647|NCT00682786|P2|Participant Flow|Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
1054648|NCT00682786|P1|Participant Flow|Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
1054649|NCT00682786|O2|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
1054650|NCT00682786|O1|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
1054651|NCT00682786|O2|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
1054652|NCT00682786|O1|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
1054653|NCT00682786|O2|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
1054654|NCT00682786|O1|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
1054655|NCT00682786|O2|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
1054656|NCT00682786|O1|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
1054657|NCT00682786|O2|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
1054658|NCT00682786|O1|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
1054659|NCT00682786|O2|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
1054660|NCT00682786|O1|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
1054661|NCT00682786|O2|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
1054662|NCT00682786|O1|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
1054663|NCT00682786|O2|Outcome|With Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
1054664|NCT00682786|O1|Outcome|Without Grade 3-4 Diarrhea and/or Mucositis|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
1055054|NCT00681291|O1|Outcome|1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r|lightweight polypropylene mesh
1054665|NCT00682786|O2|Outcome|Poor Risk (TYMS*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
1054666|NCT00682786|O1|Outcome|Good Risk (TYMS*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
1054667|NCT00682786|O2|Outcome|Poor Risk (TYMS*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
1054668|NCT00682786|O1|Outcome|Good Risk (TYMS*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
1054669|NCT00682786|O2|Outcome|Poor Risk (TYMS*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
1054670|NCT00682786|O1|Outcome|Good Risk (TYMS*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
1054671|NCT00682786|O2|Outcome|Poor Risk (TYMS*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
1054672|NCT00682786|O1|Outcome|Good Risk (TYMS*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
1054673|NCT00682786|O2|Outcome|Poor Risk (TYMS*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
1054674|NCT00682786|O1|Outcome|Good Risk (TYMS*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
1054675|NCT00682786|E2|Reported Event|Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Irinotecan 50 mg/m2 IV weekly for 5 doses.~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
1054676|NCT00682786|E1|Reported Event|Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4)|"Radiation 45 Gy in 25 fractions to the pelvis.~5FU CIVI 225 mg/m2/day by CIVI during radiation~Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable."
1054677|NCT00682734|B4|Baseline|Total|Total of all reporting groups
1054678|NCT00682734|B3|Baseline|Metoclopramide 40 mg|Metoclopramide 40 mg intravenous + diphenhdyramine 25 mg intravenous
1054679|NCT00682734|B2|Baseline|Metoclopramide 20 mg|Metoclopramide 20mg intravenous+ diphenhydrmaine 25 mg intravenous
1054680|NCT00682734|B1|Baseline|Metoclopramide 10 mg Intravenous|Metoclopramide 10 mg intravenous + diphenhydramine 25 mg intravenous
1054681|NCT00682734|P3|Participant Flow|Metoclopramide 40 mg Intravenous|Metoclopramide 40 mg intravenous + diphenhdyramine 25 mg intravenous
1054682|NCT00682734|P2|Participant Flow|Metoclopramide 20 mg Intravenous|Metoclopramide 20 mg intravenous+ diphenhydrmaine 25 mg intravenous
1054683|NCT00682734|P1|Participant Flow|Metoclopramide 10 mg Intravenous|Metoclopramide 10 mg intravenous + diphenhydramine 25mg intravenous
1054684|NCT00682734|O3|Outcome|Metoclopramide 40 mg|Metoclopramide 40mg intravenous + diphenhdyramine 25mg intravenous
1054685|NCT00682734|O2|Outcome|Metoclopramide 20 mg|Metoclopramide 20 mg intravenous+ diphenhydrmaine 25 mg intravenous
1054686|NCT00682734|O1|Outcome|Metoclopramide 10 mg Intravenous|Metoclopramide 10mg intravenous + diphenhydramine 25mg intravenous
1054687|NCT00682734|E3|Reported Event|Metoclopramide 40 mg|Metoclopramide 40 mg intravenous + diphenhdyramine 25 mg intravenous
1054688|NCT00682734|E2|Reported Event|Metoclopramide 20 mg|Metoclopramide 20mg intravenous+ diphenhydrmaine 25 mg intravenous
1054689|NCT00682734|E1|Reported Event|Metoclopramide 10 mg Intravenous|Metoclopramide 10 mg intravenous + diphenhydramine 25 mg intravenous
1054690|NCT00682643|B3|Baseline|Total|Total of all reporting groups
1054691|NCT00682643|B2|Baseline|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
1054692|NCT00682643|B1|Baseline|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
1054693|NCT00682643|P2|Participant Flow|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
1054694|NCT00682643|P1|Participant Flow|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
1054695|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
1054696|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
1054697|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
1054698|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
1054699|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
1054700|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
1054701|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
1054702|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
1054703|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
1054704|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
1054705|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
1054706|NCT00682643|O1|Outcome|Placebo|An event for IOP is defined as an increase of 7 mm Hg or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry. Participants without post-baseline ophthalmic exam data were censored at the randomization date. Change from baseline was calculated by subtracting the baseline value from the Week 52 or Week 104 value.
1054707|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
1054708|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
1054709|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
1054710|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
1054711|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
1054712|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
1054713|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
1054714|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
1054715|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
1054716|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
1054717|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
1054718|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
1054719|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
1054720|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
1054721|NCT00682643|O2|Outcome|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
1054722|NCT00682643|O1|Outcome|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
1054723|NCT00682643|E2|Reported Event|FF 110 mcg QD|FF nasal spray aqueous suspension contained 0.05% micronized FF. Each spray contained approximately 27.5 micrograms (mcg) of FF; participants self-administered two sprays per nostril each morning QD for a total dose of 110 mcg for 104 weeks.
1054724|NCT00682643|E1|Reported Event|Placebo|The matching placebo nasal spray containing only fluticasone furoate (FF) vehicle was self-administered as two sprays per nostril each morning once daily (QD) for 104 weeks.
1054725|NCT00682565|B4|Baseline|Total|Total of all reporting groups
1054726|NCT00682565|B3|Baseline|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
1054727|NCT00682565|B2|Baseline|High Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
1055055|NCT00681291|E2|Reported Event|2Strattice (Utilized for Inguinal Hernia Repair)|Strattice
1054728|NCT00682565|B1|Baseline|Mid Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
1054729|NCT00682565|P3|Participant Flow|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
1054730|NCT00682565|P2|Participant Flow|High Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
1054731|NCT00682565|P1|Participant Flow|Mid Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
1054732|NCT00682565|O3|Outcome|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
1054733|NCT00682565|O2|Outcome|High Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
1054734|NCT00682565|O1|Outcome|Mid Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
1054735|NCT00682565|O3|Outcome|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
1054736|NCT00682565|O2|Outcome|High Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
1054737|NCT00682565|O1|Outcome|Mid Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
1054738|NCT00682565|O3|Outcome|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
1054739|NCT00682565|O2|Outcome|High Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
1054740|NCT00682565|O1|Outcome|Mid Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
1054741|NCT00682565|O3|Outcome|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
1054742|NCT00682565|O2|Outcome|High Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
1054743|NCT00682565|O1|Outcome|Mid Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
1054744|NCT00682565|O3|Outcome|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
1054745|NCT00682565|O2|Outcome|High Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
1054746|NCT00682565|O1|Outcome|Mid Dose Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
1054747|NCT00682565|E4|Reported Event|Total|All Patients
1054748|NCT00682565|E3|Reported Event|All Placebo|20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
1054749|NCT00682565|E2|Reported Event|Cohort 2 Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
1054750|NCT00682565|E1|Reported Event|Cohort 1 Active Drug|CK-1827452 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
1054751|NCT00682539|B4|Baseline|Total|Total of all reporting groups
1054752|NCT00682539|B3|Baseline|Lucentis|After a loading dose of three monthly injections of 0.5mg Lucentis, PRN treatment based on predefined morphological and functional retreatment criteria, that were reassessed monthly.
1054753|NCT00682539|B2|Baseline|Triamciolone|Baseline injection of 8mg intravitreally applied triamcinolone was followed by two sham injections at month 1 and 2. Sham injections were only mimicked without penetration of the ocular globe after the same pre-injection procedure. Beginning at month 3 patients were treated as needed (PRN) based on predefined morphological and functional retreatment criteria, that were reassessed monthly. Triamcinolone was injected no more than every three months intermitted by sham injections to maintain patient masking.
1054754|NCT00682539|B1|Baseline|Avastin|After a loading dose of three monthly injections of 2.5mg Avastin, PRN treatment based on predefined morphological and functional retreatment criteria, that were reassessed monthly.
1054755|NCT00682539|P3|Participant Flow|Lucentis|15 patients with clinical significant macular edema receive an injection of 0,5 mg Lucentis every month. After three initial injections of Lucentis re-injection is performed as needed following a predefined protocol.
1054756|NCT00682539|P2|Participant Flow|Triamciolone|30 patients with a clinical significant diabetic macular edema receive an intraocular injection of 8mg triamcinolone at baseline under sterile conditions. 1 and 2 month after the baseline injection, patients receive a sham injection. After three month re-injection of 8mg Triamcinolone is performed as needed following a predefined protocol. In between two injection of 8mg Triamcinolone must be an temporal interval of at least 3 months.
1054757|NCT00682539|P1|Participant Flow|Avastin|15 patients with clinical significant macular edema receive an injection of 2,5 mg Avastin every month. After three initial injections of Avastin re-injection is performed following a predefined protocol.
1054758|NCT00682539|O3|Outcome|Lucentis|Loading dose of three monthly 0.5mg Lucentis injections followed by PRN treatment.
1054759|NCT00682539|O2|Outcome|Triamciolone|Initial 8mg intravitreally applied Triamcinolone followed by two sham injections. PRN treatment from month 3.
1054760|NCT00682539|O1|Outcome|Avastin|Loading dose of three monthly 2.5mg Avastin injections followed by PRN treatment.
1054761|NCT00682539|O3|Outcome|Lucentis|Loading dose of three monthly 0.5mg Lucentis injections followed by PRN treatment.
1054762|NCT00682539|O2|Outcome|Triamciolone|Initial 8mg intravitreally applied Triamcinolone followed by two sham injections. PRN treatment from month 3.
1054763|NCT00682539|O1|Outcome|Avastin|Loading dose of three monthly 2.5mg Avastin injections followed by PRN treatment.
1054764|NCT00682539|E3|Reported Event|Lucentis|15 patients with clinical significant macular edema receive an injection of 0,5 mg Lucentis every month. After three initial injections of Lucentis re-injection is performed if needed.
1054765|NCT00682539|E2|Reported Event|Triamciolone|30 patients with a clinical significant diabetic macular edema receive an intraocular injection of 8mg triamcinolone at baseline under sterile conditions. 1 and 2 month after the baseline injection, patients receive a sham injection. After three month re-injection of 8mg Triamcinolone is performed if needed. In between two injection of 8mg Triamcinolone must be an temporal interval of at least 3 months.
1057674|NCT00674128|O2|Outcome|Suture|Polyglactin 910 suture.
1054766|NCT00682539|E1|Reported Event|Avastin|Patients with clinical significant macular edema receive an injection of 2,5 mg Avastin every month. After three initial injections of Avastin re-injection is performed as needed.
1054767|NCT00682461|B3|Baseline|Total|Total of all reporting groups
1054768|NCT00682461|B2|Baseline|Nicotine Lozenge (2.0 mg)|Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
1054769|NCT00682461|B1|Baseline|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
1054770|NCT00682461|P2|Participant Flow|Nicotine Lozenge (2.0 mg)|Prticipants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
1054771|NCT00682461|P1|Participant Flow|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
1054772|NCT00682461|O2|Outcome|Nicotine Lozenge (2.0 mg)|Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
1054773|NCT00682461|O1|Outcome|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
1054774|NCT00682461|O2|Outcome|Nicotine Lozenge (2.0 mg)|Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
1054775|NCT00682461|O1|Outcome|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
1054776|NCT00682461|O2|Outcome|Nicotine Lozenge (2.0 mg)|Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
1054777|NCT00682461|O1|Outcome|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
1054778|NCT00682461|O2|Outcome|Nicotine Lozenge (2.0 mg)|Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
1054779|NCT00682461|O1|Outcome|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
1054780|NCT00682461|O2|Outcome|Nicotine Lozenge (2.0 mg)|Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
1054781|NCT00682461|O1|Outcome|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth strip, not exceeding a maximum limit of 15 per day
1054782|NCT00682461|E2|Reported Event|Nicotine Lozenge (2.0 mg)|Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum of 15 per day
1054783|NCT00682461|E1|Reported Event|Nicotine Mouth Strip (2.5 mg)|Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
1054784|NCT00682357|B4|Baseline|Total|Total of all reporting groups
1054785|NCT00682357|B3|Baseline|Group 3 - Placebo|Placebo and Lidocaine: Placebo and lidocaine 20 mg
1054786|NCT00682357|B2|Baseline|Group 2 - Low Dose|Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
1054787|NCT00682357|B1|Baseline|Group 1 - Standard Dose|Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
1054788|NCT00682357|P3|Participant Flow|Group 3 - Placebo|Placebo and Lidocaine: Placebo and lidocaine 20 mg
1054789|NCT00682357|P2|Participant Flow|Group 2 - Low Dose|Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
1054790|NCT00682357|P1|Participant Flow|Group 1 - Standard Dose|Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
1054791|NCT00682357|O3|Outcome|Group 3 - Placebo|Placebo and Lidocaine: Placebo and lidocaine 20 mg
1054792|NCT00682357|O2|Outcome|Group 2 - Low Dose|Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
1054793|NCT00682357|O1|Outcome|Group 1 - Standard Dose|Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
1054794|NCT00682357|O3|Outcome|Group 3 - Placebo|Placebo and Lidocaine: Placebo and lidocaine 20 mg
1054795|NCT00682357|O2|Outcome|Group 2 - Low Dose|Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
1054796|NCT00682357|O1|Outcome|Group 1 - Standard Dose|Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
1054797|NCT00682357|O3|Outcome|Group 3 - Placebo|Placebo and Lidocaine: Placebo and lidocaine 20 mg
1054798|NCT00682357|O2|Outcome|Group 2 - Low Dose|Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
1054799|NCT00682357|O1|Outcome|Group 1 - Standard Dose|Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
1054800|NCT00682357|O3|Outcome|Group 3 - Placebo|Placebo and Lidocaine: Placebo and lidocaine 20 mg
1054801|NCT00682357|O2|Outcome|Group 2 - Low Dose|Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
1054802|NCT00682357|O1|Outcome|Group 1 - Standard Dose|Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
1054803|NCT00682357|E3|Reported Event|Group 3 - Placebo|Placebo and Lidocaine: Placebo and lidocaine 20 mg
1054804|NCT00682357|E2|Reported Event|Group 2 - Low Dose|Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg
1054805|NCT00682357|E1|Reported Event|Group 1 - Standard Dose|Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg
1054806|NCT00681889|B1|Baseline|Treatment Arm|"10 Patients will receive treatment (Ranibizumab)~Ranibizumab : 10 Patients will receive treatment (Ranibizumab)"
1054807|NCT00681889|P1|Participant Flow|Treatment Arm|"10 eyes of 9 patients will receive treatment (Ranibizumab)~Ranibizumab : 10 eyes of 9 patients will receive treatment (Ranibizumab)"
1054808|NCT00681889|O1|Outcome|Treatment Arm|"9 Patients will receive treatment (Ranibizumab)~Ranibizumab : 9 Patients will receive treatment (Ranibizumab)"
1054809|NCT00681889|E1|Reported Event|Treatment Arm|"10 eyes of 9 patients will receive treatment (Ranibizumab)~Ranibizumab : 10 eyes of 9 patients will receive treatment (Ranibizumab)"
1054810|NCT00681863|B1|Baseline|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054811|NCT00681863|P1|Participant Flow|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID (twice daily), down-titration to 0.0625 QD (once daily) if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID (three times daily) and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054812|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054813|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054814|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054815|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054816|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054817|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054818|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054819|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054820|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054821|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054822|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054823|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054824|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054825|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054826|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054827|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054828|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054829|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054830|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054831|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054832|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054884|NCT00681811|O7|Outcome|100 U/kg HGT-1111 (Month 24)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 24.
1057675|NCT00674128|O1|Outcome|Adhesive|Cyanoacrylate tissue adhesive.
1054833|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054834|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054835|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054836|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054837|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054838|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054839|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054840|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054841|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054842|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054843|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054844|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054845|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054846|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054847|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054848|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054849|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054850|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054851|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054852|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054853|NCT00681863|O1|Outcome|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054854|NCT00681863|E1|Reported Event|Pramipexole|4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period.
1054855|NCT00681824|B4|Baseline|Total|Total of all reporting groups
1054885|NCT00681811|O6|Outcome|200 U/kg HGT-1111 (Month 18)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 18.
1054856|NCT00681824|B3|Baseline|FS VH S/D 500 S-apr (Non Run-In Participants Only)|"Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group does not include the 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)"
1054857|NCT00681824|B2|Baseline|FS VH S/D 500 S-apr (Run-In Participants Only)|"Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group only includes the 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)"
1054858|NCT00681824|B1|Baseline|Standard of Care (SoC)|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
1054859|NCT00681824|P3|Participant Flow|FS VH S/D 500 S-apr|Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes.
1054860|NCT00681824|P2|Participant Flow|Run-in Participants: FS VH S/D 500 S-apr|One initial
1054861|NCT00681824|P1|Participant Flow|Standard of Care|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
1054862|NCT00681824|O2|Outcome|FS VH S/D 500 S-apr|Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group includes 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)
1054863|NCT00681824|O1|Outcome|Standard of Care|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
1054864|NCT00681824|O2|Outcome|FS VH S/D 500 S-apr|Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group includes 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)
1054865|NCT00681824|O1|Outcome|Standard of Care|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
1054866|NCT00681824|O2|Outcome|FS VH S/D 500 S-apr|Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group does not include 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)
1054867|NCT00681824|O1|Outcome|Standard of Care (SoC)|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
1054868|NCT00681824|O2|Outcome|FS VH S/D 500 S-apr|Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group does not include 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)
1054869|NCT00681824|O1|Outcome|Standard of Care (SoC)|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
1054870|NCT00681824|O2|Outcome|FS VH S/D 500 S-apr|Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group does not include 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)
1054871|NCT00681824|O1|Outcome|Standard of Care (SoC)|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
1054872|NCT00681824|O2|Outcome|FS VH S/D 500 S-apr|Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group does not include 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)
1054873|NCT00681824|O1|Outcome|Standard of Care (SoC)|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
1054874|NCT00681824|E2|Reported Event|FS VH S/D 500 S-apr|"Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group includes 13 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures)"
1054875|NCT00681824|E1|Reported Event|Standard of Care (SoC)|The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
1054876|NCT00681811|B3|Baseline|Total|Total of all reporting groups
1054877|NCT00681811|B2|Baseline|200 U/kg|Participants received 200 U/kg of HGT1111 IV infusion every other week.
1054878|NCT00681811|B1|Baseline|100 U/kg HGT1111|Participants received 100 U/kg of HGT1111 IV infusion every other week.
1054879|NCT00681811|P2|Participant Flow|200 U/kg HGT-1111|Participants received 200 U/kg of HGT1111 IV infusion every other week.
1054880|NCT00681811|P1|Participant Flow|100 U/kg HGT-1111|Participants received 100 units per kilogram (U/kg) of HGT1111 intravenous (IV) infusion every other week.
1054881|NCT00681811|O2|Outcome|200 U/kg HGT-1111|Participants received 200 U/kg of HGT1111 IV infusion every other week.
1054882|NCT00681811|O1|Outcome|100 U/kg HGT-1111|Participants received 100 U/kg of HGT1111 IV infusion every other week.
1054883|NCT00681811|O8|Outcome|200 U/kg HGT-1111 (Month 24)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 24.
1054886|NCT00681811|O5|Outcome|100 U/kg HGT-1111 (Month 18)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 18.
1054887|NCT00681811|O4|Outcome|200 U/kg HGT-1111 (Month 12)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 12.
1054888|NCT00681811|O3|Outcome|100 U/kg HGT-1111 (Month 12)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 12.
1054889|NCT00681811|O2|Outcome|200 U/kg HGT-1111 (Month 6)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 6.
1054890|NCT00681811|O1|Outcome|100 U/kg HGT-1111 (Month 6)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 6.
1054891|NCT00681811|O6|Outcome|200 U/kg HGT-1111 (Month 18)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 18.
1054892|NCT00681811|O5|Outcome|100 U/kg- HGT-1111(Month 18)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 18.
1054893|NCT00681811|O4|Outcome|200 U/kg HGT-1111 (Month 12)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 12.
1054894|NCT00681811|O3|Outcome|100 U/kg- HGT-1111 (Month 12)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 12.
1054895|NCT00681811|O2|Outcome|200 U/Kg-HGT-1111(Month 6)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 6.
1054896|NCT00681811|O1|Outcome|100 U/kg HGT-1111 (Month 6)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 6.
1054897|NCT00681811|O8|Outcome|200 U/kg HGT-1111 (Month 24)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 24.
1054898|NCT00681811|O7|Outcome|100 U/kg HGT-1111 (Month 24)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 24.
1054899|NCT00681811|O6|Outcome|200 U/kg HGT-1111 (Month 18)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 18.
1054900|NCT00681811|O5|Outcome|100 U/kg HGT-1111 (Month 18)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 18.
1054901|NCT00681811|O4|Outcome|200 U/kg HGT-1111 (Month 12)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 12.
1054902|NCT00681811|O3|Outcome|100 U/kg HGT-1111 (Month 12)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 12.
1054903|NCT00681811|O2|Outcome|200 U/kg HGT-1111 (Month 6)|Participants received 200 U/kg of HGT1111 IV infusion every other week up to Month 6.
1054904|NCT00681811|O1|Outcome|100 U/kg HGT-1111 (Month 6)|Participants received 100 U/kg of HGT1111 IV infusion every other week up to Month 6.
1054905|NCT00681811|E2|Reported Event|200 U/kg HGT1111|Participants received 200 U/kg of HGT1111 IV infusion every other week.
1054906|NCT00681811|E1|Reported Event|100 U/kg HGT1111|Participants received 100 U/kg of HGT1111 IV infusion every other week.
1054907|NCT00681668|B1|Baseline|Quetiapine Fumarate 150 - 800mg|Quetiapine fumarate, tablets, 150 - 800mg oral, per day, until 28 weeks
1054908|NCT00681668|P1|Participant Flow|Quetiapine Fumarate 150 - 800mg|Quetiapine fumarate, tablets, 150 - 800mg oral, per day, until 28 weeks
1054909|NCT00681668|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate tablets
1054910|NCT00681668|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate tablets
1054911|NCT00681668|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate tablets
1054912|NCT00681668|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate tablets
1054913|NCT00681668|E1|Reported Event|Quetiapine Fumarate 150 - 800mg|Quetiapine fumarate, tablets, 150 - 800mg oral, per day, until 28 weeks
1054914|NCT00681629|B3|Baseline|Total|Total of all reporting groups
1054915|NCT00681629|B2|Baseline|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
1054916|NCT00681629|B1|Baseline|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
1054917|NCT00681629|P2|Participant Flow|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
1054918|NCT00681629|P1|Participant Flow|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
1054919|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
1054920|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
1054921|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
1054922|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
1054923|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
1054924|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
1054925|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
1054926|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
1054927|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
1054928|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
1054929|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
1054930|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
1054931|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
1054932|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
1054933|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
1054934|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
1054935|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
1054936|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
1055056|NCT00681291|E1|Reported Event|1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r|lightweight polypropylene mesh
1054937|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
1054938|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
1054939|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
1054940|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
1054941|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
1054942|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
1054943|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
1054944|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
1054945|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
1054946|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
1054947|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
1054948|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
1054949|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
1054950|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
1054951|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
1055018|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
1055085|NCT00681187|O2|Outcome|HCP Administration|A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
1054952|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
1054953|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
1054954|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
1054955|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
1054956|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
1054957|NCT00681629|O2|Outcome|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
1054958|NCT00681629|O1|Outcome|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
1054959|NCT00681629|E2|Reported Event|Quetiapine XR Alone|Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
1054960|NCT00681629|E1|Reported Event|Quetiapine XR With Integrated Care Program (ICP)|"Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion.~Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance."
1054961|NCT00681590|B3|Baseline|Total|Total of all reporting groups
1054962|NCT00681590|B2|Baseline|Vitamin D 2000 IU|participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose)
1054963|NCT00681590|B1|Baseline|Vitamin D 400 IU|participants received one tablet containing cholecalciferol 400 IU daily orally (low dose)
1054964|NCT00681590|P2|Participant Flow|Vitamin D 2000 IU|participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose)
1054965|NCT00681590|P1|Participant Flow|Vitamin D 400 IU|participants received one tablet containing cholecalciferol 400 IU daily orally (low dose)
1054966|NCT00681590|O2|Outcome|Vitamin D 2000 IU|participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose)
1054967|NCT00681590|O1|Outcome|Vitamin D 400 IU|participants received one tablet containing cholecalciferol 400 IU daily orally (low dose)
1054968|NCT00681590|O2|Outcome|Vitamin D 2000 IU|participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose)
1054969|NCT00681590|O1|Outcome|Vitamin D 400 IU|participants received one tablet containing cholecalciferol 400 IU daily orally (low dose)
1054970|NCT00681590|E2|Reported Event|Vitamin D 2000 IU|participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose)
1054971|NCT00681590|E1|Reported Event|Vitamin D 400 IU|participants received one tablet containing cholecalciferol 400 IU daily orally (low dose)
1054972|NCT00681564|B3|Baseline|Total|Total of all reporting groups
1054973|NCT00681564|B2|Baseline|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
1054974|NCT00681564|B1|Baseline|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
1054975|NCT00681564|P2|Participant Flow|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
1055051|NCT00681291|O2|Outcome|2Strattice (Utilized for Inguinal Hernia Repair)|Strattice
1055052|NCT00681291|O1|Outcome|1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r|lightweight polypropylene mesh
1057676|NCT00674128|E2|Reported Event|Suture|Polyglactin 910 suture
1054976|NCT00681564|P1|Participant Flow|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
1054977|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
1054978|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
1054979|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
1054980|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
1054981|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
1054982|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
1054983|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
1054984|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
1054985|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
1054986|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
1054987|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
1054988|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
1054989|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
1054990|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
1054991|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
1054992|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
1054993|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
1054994|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
1054995|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
1054996|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
1054997|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
1054998|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
1054999|NCT00681564|O2|Outcome|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
1055000|NCT00681564|O1|Outcome|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
1055001|NCT00681564|E2|Reported Event|Periodontal Prophylaxis (Active Comparator)|"Periodontal care: - Basic oral hygiene instructions~- Supragingival plaque removal"
1055002|NCT00681564|E1|Reported Event|Periodontal Intervention (Experimental)|"One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session~Tongue brushing with a 1% chlorhexidine gel (1 minute)~Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)~Subgingival chlorhexidine (1%) irrigation in all pockets~Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention~Basic oral hygiene instructions~Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)"
1055003|NCT00681538|B3|Baseline|Total|Total of all reporting groups
1055004|NCT00681538|B2|Baseline|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
1055005|NCT00681538|B1|Baseline|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
1055006|NCT00681538|P2|Participant Flow|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
1055007|NCT00681538|P1|Participant Flow|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
1055008|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
1055009|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
1055010|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
1055011|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
1055012|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
1055013|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
1055014|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
1055015|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
1055016|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
1055017|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
1055053|NCT00681291|O2|Outcome|2Strattice (Utilized for Inguinal Hernia Repair)|Strattice
1055404|NCT00680745|O4|Outcome|Placebo + Glimepiride|Placebo comparator plus glimepiride
1055019|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
1055020|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
1055021|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
1055022|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
1055023|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
1055024|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
1055025|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
1055026|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
1055027|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
1055028|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
1055029|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
1055030|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
1055031|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
1055032|NCT00681538|O2|Outcome|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
1055033|NCT00681538|O1|Outcome|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
1055034|NCT00681538|E2|Reported Event|Placebo (Phase B)|Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.
1055035|NCT00681538|E1|Reported Event|Sativex (Phase B)|contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours.
1055036|NCT00681473|B1|Baseline|Proton Radiation Therapy|Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.
1055037|NCT00681473|P1|Participant Flow|Proton Radiation Therapy|Proton Radiation Therapy daily (Monday through Friday) for six weeks. This is a single arm study.
1055038|NCT00681473|O1|Outcome|Proton Radiation Therapy|Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.
1055039|NCT00681473|O1|Outcome|Proton Radiation Therapy|Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.
1055040|NCT00681473|O1|Outcome|Proton Radiation Therapy|Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.
1055041|NCT00681473|E1|Reported Event|Proton Radiation Therapy|Proton radiation therapy daily (Monday through Friday) for six weeks. This is a single arm study.
1055042|NCT00681291|B3|Baseline|Total|Total of all reporting groups
1055043|NCT00681291|B2|Baseline|2Strattice (Utilized for Inguinal Hernia Repair)|Strattice
1055044|NCT00681291|B1|Baseline|1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r|lightweight polypropylene mesh
1055045|NCT00681291|P2|Participant Flow|2Strattice (Utilized for Inguinal Hernia Repair)|Strattice
1055046|NCT00681291|P1|Participant Flow|1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r|lightweight polypropylene mesh
1055047|NCT00681291|O2|Outcome|2Strattice (Utilized for Inguinal Hernia Repair)|Strattice
1055048|NCT00681291|O1|Outcome|1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r|lightweight polypropylene mesh
1055049|NCT00681291|O2|Outcome|2Strattice (Utilized for Inguinal Hernia Repair)|Strattice
1055050|NCT00681291|O1|Outcome|1lightweight Polypropylene Mesh(Utilized for Inguinal Hernia r|lightweight polypropylene mesh
1057723|NCT00673855|O2|Outcome|Lubricant Eye Drops|Lubricant Eye Drops
1055057|NCT00681265|B1|Baseline|Glycerin Eye Drop / PEG 400 and Propylene Glycol Eye Drop|One eye will randomly receive a single instillation of one drop of a new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient. The other eye will receive a single instillation of one drop of an artificial tear with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent.
1055058|NCT00681265|P1|Participant Flow|Glycerin Eye Drop / PEG 400 and Propylene Glycol Eye Drop|One eye will randomly receive a single instillation of one drop of a new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient. The other eye will receive a single instillation of one drop of an artificial tear with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent.
1055059|NCT00681265|O2|Outcome|Propylene Glycol and PEG 400 Eye Drop|The other eye will receive a single instillation of one drop of an artificial tear with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent.
1055060|NCT00681265|O1|Outcome|New Formulation of Glycerin 1% Eye Drop|One eye will randomly receive a single instillation of one drop of a new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient.
1055061|NCT00681265|O2|Outcome|Propylene Glycol and PEG 400 Eye Drop|The other eye will receive a single instillation of one drop of an artificial tear with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent.
1055062|NCT00681265|O1|Outcome|New Formulation of Glycerin 1% Eye Drop|One eye will randomly receive a single instillation of one drop of a new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient.
1055063|NCT00681265|E2|Reported Event|Propylene Glycol and PEG 400 Eye Drop|The other eye will receive a single instillation of one drop of an artificial tear with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent.
1055064|NCT00681265|E1|Reported Event|New Formulation of Glycerin 1% Eye Drop|One eye will randomly receive a single instillation of one drop of a new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient.
1055065|NCT00681187|B3|Baseline|Total|Total of all reporting groups
1055066|NCT00681187|B2|Baseline|Group 2 HCP Then Self or Partner Administration|Administration by HCP then self or partner administration.
1055067|NCT00681187|B1|Baseline|Group 1 Self or Partner First Then HCP Administration|Self or partner administration followed by HCP administration.
1055068|NCT00681187|P2|Participant Flow|Group 2 HCP Then Self or Partner Administration|Started with a healthcare administration block with three HCP provided injections according to clinical routine every 28th day. A training period followed the healthcare administration block with two or three training injections performed by the subject or partner under supervision at the healthcare provider facilities. A self-administration block followed the training injections with 3 subsequent unsupervised injections every 28th day at the subject’s home. The subject visited the clinic for a follow-up visit 14 days after the last self-partner administered injection.
1055069|NCT00681187|P1|Participant Flow|Group 1 Self or Partner First Then HCP Administration|Started with a training period where the subject or partner performed two or three training injections under supervision of a Healthcare Professional (HCP) at a healthcare provider facility. The training injections were followed by a self administration block of three subsequent unsupervised injections every 28th day at the subject’s home. A healthcare administration block followed the self administration block with three HCP provided injections according to clinical routine every 28th day.
1055070|NCT00681187|O1|Outcome|Overall Study Group|One HCP from each site who enrolled participants answered the questions
1055071|NCT00681187|O4|Outcome|After HCP Administration|After the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
1055072|NCT00681187|O3|Outcome|Before HCP Administration|Before the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
1055073|NCT00681187|O2|Outcome|After Self or Partner Administration|After the self or partner administration block which included three unsupervised injections every 28th day at the subject's home.
1055074|NCT00681187|O1|Outcome|Before Self or Partner Administration|Before self or partner administration block (after training period) which included three unsupervised injections every 28th day at the subject's home.
1055075|NCT00681187|O4|Outcome|After HCP Administration|After the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
1055076|NCT00681187|O3|Outcome|Before HCP Administration|Before the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
1055077|NCT00681187|O2|Outcome|After Self or Partner Administration|After the self or partner administration block which included three unsupervised injections every 28th day at the subject's home.
1055078|NCT00681187|O1|Outcome|Before Self or Partner Administration|Before self or partner administration block (after training period) which included three unsupervised injections every 28th day at the subject's home.
1055079|NCT00681187|O3|Outcome|HCP Administration|A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
1055080|NCT00681187|O2|Outcome|Self or Partner Administration|The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject's home.
1055081|NCT00681187|O1|Outcome|Baseline|Baseline refers to the last non-study visit at the clinic.
1055082|NCT00681187|O3|Outcome|HCP Administration|A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
1055083|NCT00681187|O2|Outcome|Self or Partner Administration|The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject's home.
1055084|NCT00681187|O1|Outcome|Baseline|Baseline refers to the last non-study visit at the clinic.
1056018|NCT00678587|B2|Baseline|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
1055086|NCT00681187|O1|Outcome|Self or Partner Administration|The self or partner administration block (after the training) included three unsupervised injections every 28th day at the subject's home.
1055087|NCT00681187|O2|Outcome|HCP Administration|A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
1055088|NCT00681187|O1|Outcome|Self or Partner Administration|The self or partner administration block (after the training period) included three unsupervised injections every 28th day at the subject's home.
1055089|NCT00681187|O3|Outcome|HCP Administration|A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
1055090|NCT00681187|O2|Outcome|Self or Partner Administration|The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject’s home.
1055091|NCT00681187|O1|Outcome|Training Period|The training period was where the subject or partner performed two or three training injections under supervision of a HCP at a healthcare provider facility.
1055092|NCT00681187|O3|Outcome|HCP Administration|A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
1055093|NCT00681187|O2|Outcome|Self or Partner Administration|The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject’s home.
1055094|NCT00681187|O1|Outcome|Training Period|The training period was where the subject or partner performed two or three training injections under supervision of a HCP at a healthcare provider facility.
1055095|NCT00681187|O2|Outcome|Group 2 HCP Then Self or Partner Administration|Administration by HCP then Self or Partner Administration.
1055096|NCT00681187|O1|Outcome|Group 1 Self or Partner First Then HCP Administration|Self or Partner Administration followed by HCP Administration.
1055097|NCT00681187|E3|Reported Event|HCP Administration|A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
1055098|NCT00681187|E2|Reported Event|Self or Partner Administration|The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject’s home.
1055099|NCT00681187|E1|Reported Event|Training Period|The training period was where the subject or partner performed two or three training injections under supervision of a HCP at a healthcare provider facility.
1055100|NCT00681109|B4|Baseline|Total|Total of all reporting groups
1055101|NCT00681109|B3|Baseline|5% IL-1Ra|Anakinra 5% Topical Ophthalmic Solution
1055102|NCT00681109|B2|Baseline|Placebo|Artificial Tear Topical Ophthalmic Solution
1055103|NCT00681109|B1|Baseline|2.5% IL-1Ra|Anakinra 2.5% Topical Ophthalmic Solution
1055104|NCT00681109|P3|Participant Flow|5% IL-1Ra|Anakinra (IL-1Ra) 5% Topical Ophthalmic Solution three times per day.
1055105|NCT00681109|P2|Participant Flow|Placebo|Artificial Tear Topical Ophthalmic Solution three times per day.
1055106|NCT00681109|P1|Participant Flow|2.5% IL-1Ra|Anakinra (IL-1Ra) 2.5% Topical Ophthalmic Solution three times per day.
1055107|NCT00681109|O3|Outcome|Anakinra 5% Topical Ophthalmic Solution|The OSDI was assessed for patients taking Anakinra (KINERET) 5%. The outcome presented is a number that represents the percent change in OSDI score from baseline to week 12.
1055108|NCT00681109|O2|Outcome|Artificial Tear Topical Ophthalmic Solution|The OSDI was assessed for patients taking placebo. The outcome presented is a number that represents the percent change in OSDI score from baseline to week 12.
1055109|NCT00681109|O1|Outcome|Anakinra 2.5% Topical Ophthalmic Solution|In this study, the OSDI was assessed for patients taking Anakinra (KINERET) 2.5%. The outcome presented is a number that represents the percent change in OSDI score from baseline to week 12.
1055110|NCT00681109|E3|Reported Event|5% IL-1Ra|Anakinra 5% Topical Ophthalmic Solution
1055111|NCT00681109|E2|Reported Event|Placebo|Artificial Tear Topical Ophthalmic Solution
1055112|NCT00681109|E1|Reported Event|2.5% IL-1Ra|Anakinra 2.5% Topical Ophthalmic Solution
1055113|NCT00680316|B3|Baseline|Total|Total of all reporting groups
1055114|NCT00680316|B2|Baseline|Placebo|2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
1055115|NCT00680316|B1|Baseline|Dornase Alfa|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
1055116|NCT00680316|P2|Participant Flow|Placebo|2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
1055117|NCT00680316|P1|Participant Flow|Dornase Alfa|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
1055118|NCT00680316|O2|Outcome|Placebo|2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
1055119|NCT00680316|O1|Outcome|Dornase Alfa|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
1055120|NCT00680316|O2|Outcome|Placebo|2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
1055121|NCT00680316|O1|Outcome|Dornase Alfa|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
1055122|NCT00680316|O2|Outcome|Placebo|2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
1055123|NCT00680316|O1|Outcome|Dornase Alfa|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
1055124|NCT00680316|O2|Outcome|Placebo|2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
1055125|NCT00680316|O1|Outcome|Dornase Alfa|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
1055126|NCT00680316|E2|Reported Event|Placebo|2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days
1055127|NCT00680316|E1|Reported Event|Dornase Alfa|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
1055128|NCT00679211|B1|Baseline|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
1055129|NCT00679211|P1|Participant Flow|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
1055174|NCT00679172|O3|Outcome|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1056019|NCT00678587|B1|Baseline|Placebo|Matching placebo
1055130|NCT00679211|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
1055131|NCT00679211|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
1055132|NCT00679211|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
1055133|NCT00679211|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
1055134|NCT00679211|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
1055135|NCT00679211|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
1055136|NCT00679211|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
1055137|NCT00679211|O2|Outcome|9 Months of Follow-up|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
1055138|NCT00679211|O1|Outcome|6 Months of Follow-up|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
1055139|NCT00679211|E1|Reported Event|Trastuzumab Emtansine|Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.
1055140|NCT00679172|B6|Baseline|Total|Total of all reporting groups
1055141|NCT00679172|B5|Baseline|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
1055142|NCT00679172|B4|Baseline|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055143|NCT00679172|B3|Baseline|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055144|NCT00679172|B2|Baseline|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055145|NCT00679172|B1|Baseline|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055146|NCT00679172|P5|Participant Flow|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
1055147|NCT00679172|P4|Participant Flow|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055148|NCT00679172|P3|Participant Flow|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055149|NCT00679172|P2|Participant Flow|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055150|NCT00679172|P1|Participant Flow|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055151|NCT00679172|O2|Outcome|Placebo - Cohort 2|Placebo comparator comprised of excipients only - Cohort 2
1055152|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055153|NCT00679172|O2|Outcome|Placebo - Cohort 2|Placebo comparator comprised of excipients only - Cohort 2
1055154|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055155|NCT00679172|O2|Outcome|Placebo - Cohort 2|Placebo comparator comprised of excipients only - Cohort 2
1055156|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055157|NCT00679172|O5|Outcome|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
1055158|NCT00679172|O4|Outcome|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055159|NCT00679172|O3|Outcome|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055160|NCT00679172|O2|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055161|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055162|NCT00679172|O5|Outcome|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
1055163|NCT00679172|O4|Outcome|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055164|NCT00679172|O3|Outcome|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055165|NCT00679172|O2|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055166|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055167|NCT00679172|O5|Outcome|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
1055168|NCT00679172|O4|Outcome|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055169|NCT00679172|O3|Outcome|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055170|NCT00679172|O2|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055171|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055172|NCT00679172|O5|Outcome|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
1055173|NCT00679172|O4|Outcome|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC- ssaV-) ZH9.
1055176|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055177|NCT00679172|O5|Outcome|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
1055178|NCT00679172|O4|Outcome|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055179|NCT00679172|O3|Outcome|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055180|NCT00679172|O2|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055181|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055182|NCT00679172|O5|Outcome|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
1055183|NCT00679172|O4|Outcome|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055184|NCT00679172|O3|Outcome|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055185|NCT00679172|O2|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055186|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055187|NCT00679172|O5|Outcome|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
1055188|NCT00679172|O4|Outcome|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055189|NCT00679172|O3|Outcome|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055190|NCT00679172|O2|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055191|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055192|NCT00679172|O5|Outcome|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
1055193|NCT00679172|O4|Outcome|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055194|NCT00679172|O3|Outcome|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055195|NCT00679172|O2|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055196|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055197|NCT00679172|O5|Outcome|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
1055198|NCT00679172|O4|Outcome|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055199|NCT00679172|O3|Outcome|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055200|NCT00679172|O2|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055201|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055202|NCT00679172|O5|Outcome|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
1055203|NCT00679172|O4|Outcome|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055204|NCT00679172|O3|Outcome|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055205|NCT00679172|O2|Outcome|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055206|NCT00679172|O1|Outcome|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055207|NCT00679172|E5|Reported Event|Pooled Placebo|Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
1055208|NCT00679172|E4|Reported Event|M01ZH09 Vaccine Candidate Cohort 4|Dose of 1.7 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055209|NCT00679172|E3|Reported Event|M01ZH09 Vaccine Candidate Cohort 3|Dose of 1.1 x 10^10 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055210|NCT00679172|E2|Reported Event|M01ZH09 Vaccine Candidate Cohort 2|Dose of 7.5 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055211|NCT00679172|E1|Reported Event|M01ZH09 Vaccine Candidate Cohort 1|Dose of 5.0 x 10^9 CFU S. typhi (Ty2 aroC‾ssaV‾) ZH9.
1055212|NCT00679081|B1|Baseline|CelTx and Autologous CTG; Split-mouth Design|Enrolled subjects had 2 non-adjacent teeth in contralateral quadrants of the same jaw identified and randomized to treatment with CelTx or autologous sub-epithelial connective tissue graft (CTG). Either a folded or a single layer of CelTx or autologous sub-epithelial CTG was applied to the teeth selected for treatment according to the randomization scheme; only 1 tooth was treated per quadrant. The harvested autologous sub-epithelial CTG was shaped to fit the recipient site and was similar in size to CelTx. Surgical site preparation and CelTx and autologous sub-epithelial CTG placement were the same for both treatment sites.
1055213|NCT00679081|P1|Participant Flow|CelTx and Autologous CTG; Split-mouth Design|Enrolled subjects had 2 non-adjacent teeth in contralateral quadrants of the same jaw identified and randomized to treatment with CelTx or autologous sub-epithelial connective tissue graft (CTG). Either a folded or a single layer of CelTx or autologous sub-epithelial CTG was applied to the teeth selected for treatment according to the randomization scheme; only 1 tooth was treated per quadrant. The harvested autologous sub-epithelial CTG was shaped to fit the recipient site and was similar in size to CelTx. Surgical site preparation and CelTx and autologous sub-epithelial CTG placement were the same for both treatment sites.
1055214|NCT00679081|O3|Outcome|Other Location|Adverse events occurring at a site other than the CelTx or Autologous graft sites
1055215|NCT00679081|O2|Outcome|Graft Site|Adverse events occurring at the autologous sub-epithelial connective tissue graft site
1055216|NCT00679081|O1|Outcome|CelTx Site|Adverse events occurring at the CelTx site
1055217|NCT00679081|E3|Reported Event|Other Location|Adverse events occurring at a site other than the CelTx or Autologous graft sites
1055218|NCT00679081|E2|Reported Event|Graft Site|Adverse events occurring at the autologous sub-epithelial connective tissue graft site
1055219|NCT00679081|E1|Reported Event|CelTx Site|Adverse events occurring at the CelTx site
1055220|NCT00679055|B3|Baseline|Total|Total of all reporting groups
1055379|NCT00680745|B5|Baseline|Total|Total of all reporting groups
1055221|NCT00679055|B2|Baseline|Placebo|Participants will be orally administered placebo once daily for 12 weeks.
1055222|NCT00679055|B1|Baseline|MK-0736|Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks
1055223|NCT00679055|P2|Participant Flow|Placebo|Participants will be orally administered placebo once daily for 12 weeks.
1055224|NCT00679055|P1|Participant Flow|MK-0736|Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks
1055225|NCT00679055|O2|Outcome|Placebo|Participants will be orally administered placebo once daily for 12 weeks.
1055226|NCT00679055|O1|Outcome|MK-0736|Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks
1055227|NCT00679055|O2|Outcome|Placebo|Participants will be orally administered placebo once daily for 12 weeks.
1055228|NCT00679055|O1|Outcome|MK-0736|Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks
1055229|NCT00679055|O2|Outcome|Placebo|Participants will be orally administered placebo once daily for 12 weeks.
1055230|NCT00679055|O1|Outcome|MK-0736|Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks
1055231|NCT00679055|E2|Reported Event|Placebo|Participants will be orally administered placebo once daily for 12 weeks.
1055232|NCT00679055|E1|Reported Event|MK-0736|Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks
1055233|NCT00681044|B1|Baseline|SCT With Melphalan Conditioning|"Mobilization with Filgrastim Stem Cell collection Melphalan Conditioning Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC~melphalan: 70-100 mg/m2/day will be administered intravenously on Days –3 and –2~Stem Cell Infusion: infusion of previously collected stem cells on Day 0"
1055234|NCT00681044|P1|Participant Flow|SCT With Melphalan Conditioning|"Mobilization with Filgrastim Stem Cell collection (SCC) Melphalan Conditioning Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC~melphalan: 70-100 mg/m2/day will be administered intravenously on Days –3 and –2~Stem Cell Infusion: infusion of previously collected stem cells on Day 0"
1055235|NCT00681044|O1|Outcome|SCT With Melphalan Conditioning|"Mobilization with Filgrastim Stem Cell collection Melphalan Conditioning Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC~melphalan: 70-100 mg/m2/day will be administered intravenously on Days –3 and –2~Stem Cell Infusion: infusion of previously collected stem cells on Day 0"
1055236|NCT00681044|O1|Outcome|SCT With Melphalan Conditioning|"Mobilization with Filgrastim Stem Cell collection Melphalan Conditioning Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC~melphalan: 70-100 mg/m2/day will be administered intravenously on Days –3 and –2~Stem Cell Infusion: infusion of previously collected stem cells on Day 0"
1055237|NCT00681044|O1|Outcome|SCT With Melphalan Conditioning|"Mobilization with Filgrastim Stem Cell collection Melphalan Conditioning Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC~melphalan: 70-100 mg/m2/day will be administered intravenously on Days –3 and –2~Stem Cell Infusion: infusion of previously collected stem cells on Day 0"
1055238|NCT00681044|O1|Outcome|SCT With Melphalan Conditioning|"Mobilization with Filgrastim Stem Cell collection Melphalan Conditioning Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC~melphalan: 70-100 mg/m2/day will be administered intravenously on Days –3 and –2~Stem Cell Infusion: infusion of previously collected stem cells on Day 0"
1055239|NCT00681044|O1|Outcome|SCT With Melphalan Conditioning|"Mobilization with Filgrastim Stem Cell collection Melphalan Conditioning Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC~melphalan: 70-100 mg/m2/day will be administered intravenously on Days –3 and –2~Stem Cell Infusion: infusion of previously collected stem cells on Day 0"
1055240|NCT00681044|E1|Reported Event|SCT With Melphalan Conditioning|"Mobilization with Filgrastim Stem Cell collection Melphalan Conditioning Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC~melphalan: 70-100 mg/m2/day will be administered intravenously on Days –3 and –2~Stem Cell Infusion: infusion of previously collected stem cells on Day 0"
1055241|NCT00680953|B4|Baseline|Total|Total of all reporting groups
1055242|NCT00680953|B3|Baseline|Alendronate|Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
1055243|NCT00680953|B2|Baseline|Placebo|Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
1055244|NCT00680953|B1|Baseline|Denosumab|Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
1055245|NCT00680953|P3|Participant Flow|Alendronate|Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
1055246|NCT00680953|P2|Participant Flow|Placebo|Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
1055247|NCT00680953|P1|Participant Flow|Denosumab|Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
1055248|NCT00680953|O3|Outcome|Alendronate|Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
1055249|NCT00680953|O2|Outcome|Placebo|Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
1055250|NCT00680953|O1|Outcome|Denosumab|Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
1055251|NCT00680953|O3|Outcome|Alendronate|Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
1055252|NCT00680953|O2|Outcome|Placebo|Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
1055253|NCT00680953|O1|Outcome|Denosumab|Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
1055405|NCT00680745|O3|Outcome|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
1055254|NCT00680953|O3|Outcome|Alendronate|Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
1055255|NCT00680953|O2|Outcome|Placebo|Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
1055256|NCT00680953|O1|Outcome|Denosumab|Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
1055257|NCT00680953|E3|Reported Event|Alendronate|Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
1055258|NCT00680953|E2|Reported Event|Placebo|Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
1055259|NCT00680953|E1|Reported Event|Denosumab|Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
1055260|NCT00680914|B3|Baseline|Total|Total of all reporting groups
1055261|NCT00680914|B2|Baseline|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055262|NCT00680914|B1|Baseline|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055263|NCT00680914|P2|Participant Flow|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055264|NCT00680914|P1|Participant Flow|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055265|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055266|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055267|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055268|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055269|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055270|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055271|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055272|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055273|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055274|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055275|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055276|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055277|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055278|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055279|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055280|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055281|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055282|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055283|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055284|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055285|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055286|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055287|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055288|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055289|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055290|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055291|NCT00680914|O2|Outcome|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055292|NCT00680914|O1|Outcome|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055293|NCT00680914|E2|Reported Event|Prevenar Group|Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055294|NCT00680914|E1|Reported Event|Synflorix Group|Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
1055295|NCT00680901|B3|Baseline|Total|Total of all reporting groups
1055380|NCT00680745|B4|Baseline|Placebo + Glimepiride|Placebo comparator plus glimepiride
1056020|NCT00678587|P2|Participant Flow|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
1055296|NCT00680901|B2|Baseline|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
1055297|NCT00680901|B1|Baseline|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
1055298|NCT00680901|P2|Participant Flow|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
1055299|NCT00680901|P1|Participant Flow|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
1055300|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
1055301|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
1055302|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
1055303|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
1055381|NCT00680745|B3|Baseline|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
1055382|NCT00680745|B2|Baseline|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
1055383|NCT00680745|B1|Baseline|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
1055384|NCT00680745|P4|Participant Flow|Placebo + Glimepiride|Placebo comparator plus glimepiride
1055385|NCT00680745|P3|Participant Flow|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
1056021|NCT00678587|P1|Participant Flow|Placebo|Matching placebo
1055304|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
1055305|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
1055306|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
1055307|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
1055308|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
1055309|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
1055310|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
1055311|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
1055386|NCT00680745|P2|Participant Flow|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
1055387|NCT00680745|P1|Participant Flow|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
1055388|NCT00680745|O4|Outcome|Placebo + Glimepiride|Placebo comparator plus glimepiride
1055389|NCT00680745|O3|Outcome|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
1055390|NCT00680745|O2|Outcome|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
1055391|NCT00680745|O1|Outcome|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
1055312|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
1055313|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
1055314|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
1055315|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
1055316|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
1055317|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
1055318|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
1055319|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
1055392|NCT00680745|O4|Outcome|Placebo + Glimepiride|Placebo comparator plus glimepiride
1055393|NCT00680745|O3|Outcome|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
1055394|NCT00680745|O2|Outcome|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
1055395|NCT00680745|O1|Outcome|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
1055396|NCT00680745|O4|Outcome|Placebo + Glimepiride|Placebo comparator plus glimepiride
1055397|NCT00680745|O3|Outcome|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
1055320|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
1055321|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
1055322|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
1055323|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
1055324|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
1055325|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
1055326|NCT00680901|O2|Outcome|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
1055327|NCT00680901|O1|Outcome|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
1055398|NCT00680745|O2|Outcome|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
1055399|NCT00680745|O1|Outcome|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
1055400|NCT00680745|O4|Outcome|Placebo + Glimepiride|Placebo comparator plus glimepiride
1055401|NCT00680745|O3|Outcome|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
1055402|NCT00680745|O2|Outcome|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
1055403|NCT00680745|O1|Outcome|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
1055328|NCT00680901|E2|Reported Event|CapeOx + Placebo|Participants received oxaliplatin 130 mg/ m^2 IV on Day 1 of each 21-day cycle plus capecitabine 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib matching placebo from Day 1 continuously throughout each cycle even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib matching placebo were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator's discretion.
1055329|NCT00680901|E1|Reported Event|CapeOx + Lapatinib|Participants received oxaliplatin (Ox) 130 milligrams (mg)/ meters squared (m^2) intravenously (IV) on Day 1 of each 21-day cycle plus capecitabine (Cape) 1700 mg/m^2 per day orally divided into two daily doses beginning the evening of Day 1 and ending the morning of Day 15 (28 doses per cycle) followed by a minimum required 6.5 day rest period per cycle. Participants also received lapatinib 1250 mg orally once a day from Day 1 continuously throughout each cycle, even during the 6.5 day rest period. Oxaliplatin was administered for a maximum of 8 cycles; after discontinuation of oxliplatin, capecitabine and lapatinib were continued until diease progression, unacceptable toxicity, or consent withdrawal. The capecitabine dose could have been escalated to 2000 mg/m^2 per day after the completion of the first cycle at the investigator’s discretion.
1055330|NCT00680862|B1|Baseline|Group 1|VA employees
1055331|NCT00680862|P1|Participant Flow|Group 1|VA employees
1055332|NCT00680862|O1|Outcome|Group 1|VA employees
1055333|NCT00680862|E1|Reported Event|Group 1|VA employees
1055334|NCT00680836|B3|Baseline|Total|Total of all reporting groups
1055335|NCT00680836|B2|Baseline|Treatment|These patients have Irritable Bowel syndrome (IBS) and are receiving the rifaximin 550mg twice a day
1055336|NCT00680836|B1|Baseline|Placebo|These patients have Irritable Bowel syndrome (IBS) and are receiving the placebo twice a day
1055337|NCT00680836|P2|Participant Flow|Active Group|These patients have Irritable Bowel syndrome and are receiving rifaximin 550mg twice a day
1055338|NCT00680836|P1|Participant Flow|Placebo Group|These patients have Irritable Bowel syndrome and are receiving the placebo twice a day
1055339|NCT00680836|O2|Outcome|Active Group|These patients have IBS and are receiving the rifaximin 550mg twice a day
1055340|NCT00680836|O1|Outcome|Placebo Group|These patients have IBS and are receiving the placebo twice a day
1055341|NCT00680836|O2|Outcome|Active Group|These patients have IBS and are receiving the rifaximin 550mg twice a day
1055342|NCT00680836|O1|Outcome|Placebo Group|These patients have IBS and are receiving the placebo twice a day
1055343|NCT00680836|O2|Outcome|Active Group|These patients have IBS and are receiving the rifaximin 550mg twice a day
1055344|NCT00680836|O1|Outcome|Placebo Group|These patients have IBS and are receiving the placebo twice a day
1055345|NCT00680836|O2|Outcome|Active Group|These patients have IBS and are receiving the rifaximin 550mg twice a day
1055346|NCT00680836|O1|Outcome|Placebo Group|These patients have IBS and are receiving the placebo twice a day
1055347|NCT00680836|O2|Outcome|Active Group|These patients have IBS and are receiving the rifaximin 550mg twice a day
1055348|NCT00680836|O1|Outcome|Placebo Group|These patients have IBS and are receiving the placebo twice a day
1055349|NCT00680836|O2|Outcome|Active Group|These patients have IBS and are receiving the rifaximin 550mg twice a day
1055350|NCT00680836|O1|Outcome|Placebo Group|These patients have IBS and are receiving placebo tablets twice a day
1055351|NCT00680836|E2|Reported Event|Active Group|These patients have IBS and are receiving the rifaximin 550mg twice a day
1055352|NCT00680836|E1|Reported Event|Placebo Group|These patients have IBS and are receiving placebo tablets twice a day
1055353|NCT00680797|B5|Baseline|Total|Total of all reporting groups
1055354|NCT00680797|B4|Baseline|-T -E|-Testosterone, -Estrogen
1055355|NCT00680797|B3|Baseline|-T +E|"-Testosterone, +Estrogen~Estrogen: Estrogen patch"
1055356|NCT00680797|B2|Baseline|+T -E|"+Testosterone, -Estrogen~Testosterone: Testosterone gel"
1055357|NCT00680797|B1|Baseline|+T +E|"+Testosterone, +Estrogen~Testosterone: Testosterone gel~Estrogen: Estrogen patch"
1055358|NCT00680797|P4|Participant Flow|-T -E|-Testosterone, -Estrogen
1055359|NCT00680797|P3|Participant Flow|-T +E|"-Testosterone, +Estrogen~Estrogen: Estrogen patch"
1055360|NCT00680797|P2|Participant Flow|+T -E|"+Testosterone, -Estrogen~Testosterone: Testosterone gel"
1055361|NCT00680797|P1|Participant Flow|+T +E|"+Testosterone, +Estrogen~Testosterone: Testosterone gel~Estrogen: Estrogen patch"
1055362|NCT00680797|O4|Outcome|-T -E|-Testosterone, -Estrogen
1055363|NCT00680797|O3|Outcome|-T +E|"-Testosterone, +Estrogen~Estrogen: Estrogen patch"
1055364|NCT00680797|O2|Outcome|+T -E|"+Testosterone, -Estrogen~Testosterone: Testosterone gel"
1055365|NCT00680797|O1|Outcome|+T +E|"+Testosterone, +Estrogen~Testosterone: Testosterone gel~Estrogen: Estrogen patch"
1055366|NCT00680797|E4|Reported Event|-T -E|-Testosterone, -Estrogen
1055367|NCT00680797|E3|Reported Event|-T +E|"-Testosterone, +Estrogen~Estrogen: Estrogen patch"
1055368|NCT00680797|E2|Reported Event|+T -E|"+Testosterone, -Estrogen~Testosterone: Testosterone gel"
1055369|NCT00680797|E1|Reported Event|+T +E|"+Testosterone, +Estrogen~Testosterone: Testosterone gel~Estrogen: Estrogen patch"
1055370|NCT00680771|B3|Baseline|Total|Total of all reporting groups
1055371|NCT00680771|B2|Baseline|Good Sleepers|participants meetoing criteira for Good Sleepers
1055372|NCT00680771|B1|Baseline|Primary Insomnia|patients meeting criteria for primary insomnia.
1055373|NCT00680771|P2|Participant Flow|Good Sleepers|Subjects meeting criteira for Good Sleepers
1055374|NCT00680771|P1|Participant Flow|Primary Insomnia|Subjects meeting criteria for primary insomnia.
1055375|NCT00680771|O2|Outcome|Good Sleepers|participants meetoing criteira for Good Sleepers
1055376|NCT00680771|O1|Outcome|Primary Insomnia|patients meeting criteria for primary insomnia.
1055377|NCT00680771|E2|Reported Event|Good Sleepers|participants meetoing criteira for Good Sleepers
1055378|NCT00680771|E1|Reported Event|Primary Insomnia|patients meeting criteria for primary insomnia.
1055406|NCT00680745|O2|Outcome|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
1055407|NCT00680745|O1|Outcome|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
1055408|NCT00680745|O4|Outcome|Placebo + Glimepiride|Placebo comparator plus glimepiride
1055409|NCT00680745|O3|Outcome|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
1055410|NCT00680745|O2|Outcome|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
1055411|NCT00680745|O1|Outcome|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
1055412|NCT00680745|E4|Reported Event|Placebo + Glimepiride|Placebo comparator plus glimepiride
1055413|NCT00680745|E3|Reported Event|Dapagliflozin 10mg + Glimepiride|Dapagliflozin tablet 10 mg once daily plus glimepiride
1055414|NCT00680745|E2|Reported Event|Dapagliflozin 5mg + Glimepiride|Dapagliflozin tablet 5 mg once daily plus glimepiride
1055415|NCT00680745|E1|Reported Event|Dapagliflozin 2.5mg + Glimepiride|Dapagliflozin tablet 2.5 mg once daily plus glimepiride
1055416|NCT00680706|B3|Baseline|Total|Total of all reporting groups
1055417|NCT00680706|B2|Baseline|Control|Receives placebo
1055418|NCT00680706|B1|Baseline|Thiamine|Receives thiamine
1055419|NCT00680706|P2|Participant Flow|Control|Receives placebo
1055420|NCT00680706|P1|Participant Flow|Thiamine|Receives thiamine, 100 mg intravenously at baseline (time 0-hour) and again at time 24-hour.
1055421|NCT00680706|O2|Outcome|Thiamine|
1055422|NCT00680706|O1|Outcome|Control|Placebo
1055423|NCT00680706|O2|Outcome|Thiamine|
1055424|NCT00680706|O1|Outcome|Control|Placebo
1055425|NCT00680706|E2|Reported Event|Control|Receives placebo
1055426|NCT00680706|E1|Reported Event|Thiamine|Receives thiamine
1055427|NCT00680628|B3|Baseline|Total|Total of all reporting groups
1055428|NCT00680628|B2|Baseline|Tenecteplase|"Saline + Enoxaparin~0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline."
1055429|NCT00680628|B1|Baseline|Placebo|"Tenecteplase + Enoxaparin~Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.~Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: <60Kg=30mg; ≥60Kg to <70Kg=35mg; ≥70Kg to <80Kg=40mg; ≥80Kg to <90Kg=45mg; ≥90Kg=50mg"
1055430|NCT00680628|P2|Participant Flow|Tenecteplase|"Saline + Enoxaparin~0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline."
1055431|NCT00680628|P1|Participant Flow|Placebo|"Tenecteplase + Enoxaparin~Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.~Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: <60Kg=30mg; ≥60Kg to <70Kg=35mg; ≥70Kg to <80Kg=40mg; ≥80Kg to <90Kg=45mg; ≥90Kg=50mg"
1055432|NCT00680628|O2|Outcome|Tenecteplase|"Saline + Enoxaparin~0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline."
1055433|NCT00680628|O1|Outcome|Placebo|"Tenecteplase + Enoxaparin~Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.~Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: <60Kg=30mg; ≥60Kg to <70Kg=35mg; ≥70Kg to <80Kg=40mg; ≥80Kg to <90Kg=45mg; ≥90Kg=50mg"
1055434|NCT00680628|O2|Outcome|Tenecteplase|"Saline + Enoxaparin~0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline."
1055435|NCT00680628|O1|Outcome|Placebo|"Tenecteplase + Enoxaparin~Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.~Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: <60Kg=30mg; ≥60Kg to <70Kg=35mg; ≥70Kg to <80Kg=40mg; ≥80Kg to <90Kg=45mg; ≥90Kg=50mg"
1055436|NCT00680628|O2|Outcome|Tenecteplase|"Saline + Enoxaparin~0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline."
1055437|NCT00680628|O1|Outcome|Placebo|"Tenecteplase + Enoxaparin~Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.~Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: <60Kg=30mg; ≥60Kg to <70Kg=35mg; ≥70Kg to <80Kg=40mg; ≥80Kg to <90Kg=45mg; ≥90Kg=50mg"
1055438|NCT00680628|E2|Reported Event|Tenecteplase|"Saline + Enoxaparin~0.9% Saline + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving saline."
1055439|NCT00680628|E1|Reported Event|Placebo|"Tenecteplase + Enoxaparin~Tenecteplase + Enoxaparin : Enoxaparin: 1 mg/kg within 12 hours before receiving tenecteplase.Subsequently, patients will receive 1 mg/kg enoxaparin SQ Q12 hours until discontinuation is clinically indicated.~Tenecteplase:will be administered using a tiered-dosing schedule according to patient weight: <60Kg=30mg; ≥60Kg to <70Kg=35mg; ≥70Kg to <80Kg=40mg; ≥80Kg to <90Kg=45mg; ≥90Kg=50mg"
1055440|NCT00680524|B1|Baseline|Arm 1|"Open pilot trial~Phone-based outreach: Nurse care managers will use a phone call outreach intervention with structured templated notes to help deliver evidence-based care for PTSD"
1055441|NCT00680524|P1|Participant Flow|Arm 1|"Open pilot trial~Phone-based outreach: Nurse care managers will use a phone call outreach intervention with structured templated notes to help deliver evidence-based care for PTSD"
1055442|NCT00680524|O1|Outcome|Arm 1|"Open pilot trial~Phone-based outreach: Nurse care managers will use a phone call outreach intervention with structured templated notes to help deliver evidence-based care for PTSD"
1055443|NCT00680524|E1|Reported Event|Arm 1|"Open pilot trial~Phone-based outreach: Nurse care managers will use a phone call outreach intervention with structured templated notes to help deliver evidence-based care for PTSD"
1055444|NCT00680459|B3|Baseline|Total|Total of all reporting groups
1055475|NCT00680407|E1|Reported Event|Silymarin 420 mg|"420 mg Legalon (silymarin) three times daily~Silymarin 420 mg: 420 mg dose (5 pills, three times daily) for 48-50 week treatment period"
1058585|NCT00672100|B4|Baseline|Total|Total of all reporting groups
1056026|NCT00678587|O1|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
1055445|NCT00680459|B2|Baseline|Heparin Flush|heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
1055446|NCT00680459|B1|Baseline|70% Ethanol Solution|70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
1055447|NCT00680459|P2|Participant Flow|Heparin Flush|heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
1055448|NCT00680459|P1|Participant Flow|70% Ethanol Solution|70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
1055449|NCT00680459|O2|Outcome|Heparin Flush|heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
1055450|NCT00680459|O1|Outcome|70% Ethanol Solution|70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
1055451|NCT00680459|O2|Outcome|Heparin Flush|heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
1055452|NCT00680459|O1|Outcome|70% Ethanol Solution|70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
1055453|NCT00680459|O2|Outcome|Heparin Flush|heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
1055454|NCT00680459|O1|Outcome|70% Ethanol Solution|70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
1055455|NCT00680459|E2|Reported Event|Heparin Flush|heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
1055456|NCT00680459|E1|Reported Event|70% Ethanol Solution|70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
1055457|NCT00680407|B4|Baseline|Total|Total of all reporting groups
1055458|NCT00680407|B3|Baseline|Placebo|"Placebo (lactose pill)~Placebo: Placebo (5 pills, three times daily) for 48-50 week treatment period"
1055459|NCT00680407|B2|Baseline|Silymarin 700 mg|"700 mg of Legalon (silymarin) three times daily~Silymarin 700 mg: 700 mg dose (5 pills, three times daily) for 48-50 week treatment period"
1055460|NCT00680407|B1|Baseline|Silymarin 420 mg|"420 mg Legalon (silymarin) three times daily~Silymarin 420 mg: 420 mg dose (5 pills, three times daily) for 48-50 week treatment period"
1055461|NCT00680407|P3|Participant Flow|Placebo|"Placebo (lactose pill)~Placebo: Placebo (5 pills, three times daily) for 48-50 week treatment period"
1055462|NCT00680407|P2|Participant Flow|Silymarin 700 mg|"700 mg of Legalon (silymarin) three times daily~Silymarin 700 mg: 700 mg dose (5 pills, three times daily) for 48-50 week treatment period"
1055463|NCT00680407|P1|Participant Flow|Silymarin 420 mg|"420 mg Legalon (silymarin) three times daily~Silymarin 420 mg: 420 mg dose (5 pills, three times daily) for 48-50 week treatment period"
1055464|NCT00680407|O3|Outcome|Placebo|"Placebo (lactose pill)~Placebo: Placebo (5 pills, three times daily) for 48-50 week treatment period"
1055465|NCT00680407|O2|Outcome|Silymarin 700 mg|"700 mg of Legalon (silymarin) three times daily~Silymarin 700 mg: 700 mg dose (5 pills, three times daily) for 48-50 week treatment period"
1055466|NCT00680407|O1|Outcome|Silymarin 420 mg|"420 mg Legalon (silymarin) three times daily~Silymarin 420 mg: 420 mg dose (5 pills, three times daily) for 48-50 week treatment period"
1055467|NCT00680407|O3|Outcome|Placebo|"Placebo (lactose pill)~Placebo: Placebo (5 pills, three times daily) for 48-50 week treatment period"
1055468|NCT00680407|O2|Outcome|Silymarin 700 mg|"700 mg of Legalon (silymarin) three times daily~Silymarin 700 mg: 700 mg dose (5 pills, three times daily) for 48-50 week treatment period"
1055469|NCT00680407|O1|Outcome|Silymarin 420 mg|"420 mg Legalon (silymarin) three times daily~Silymarin 420 mg: 420 mg dose (5 pills, three times daily) for 48-50 week treatment period"
1055470|NCT00680407|O3|Outcome|Placebo|"Placebo (lactose pill)~Placebo: Placebo (5 pills, three times daily) for 48-50 week treatment period"
1055471|NCT00680407|O2|Outcome|Silymarin 700 mg|"700 mg of Legalon (silymarin) three times daily~Silymarin 700 mg: 700 mg dose (5 pills, three times daily) for 48-50 week treatment period"
1055472|NCT00680407|O1|Outcome|Silymarin 420 mg|"420 mg Legalon (silymarin) three times daily~Silymarin 420 mg: 420 mg dose (5 pills, three times daily) for 48-50 week treatment period"
1055473|NCT00680407|E3|Reported Event|Placebo|"Placebo (lactose pill)~Placebo: Placebo (5 pills, three times daily) for 48-50 week treatment period"
1055474|NCT00680407|E2|Reported Event|Silymarin 700 mg|"700 mg of Legalon (silymarin) three times daily~Silymarin 700 mg: 700 mg dose (5 pills, three times daily) for 48-50 week treatment period"
1055476|NCT00680368|B1|Baseline|Physician Residents and Attending Physicians|includes physician residents and attending physicians who were asked to sit through a face to face interview with a research assistant following a clinical encounter with a patient
1055477|NCT00680368|P1|Participant Flow|Group 1|The study began with 112 responders: 75 physician residents and 37 attending physicians. Only 60 of the 75 residents had been supervised by one of the 37 participating attending physicians. Thus, 15 residents were dropped from study. Both resident and their attending physician were surveyed to report total supervision time for each of 148 clinical encounters with 143 patients. There were more clinical encounters than patients because some patients had more than one encounter. There were more physician residents than attending physicians because attending physicians may have supervised more than one resident. There were more clinical encounters than residents because a resident may be involved in more than one clinical encounter with a patient.
1055478|NCT00680368|O1|Outcome|Attending Physicians|Results reported only for the 37 attending physicians in the study sample
1055479|NCT00680368|O1|Outcome|Physician Residents|Includes physician residents who had a supervising attending physician participating in the study, and who received a face to face interview with a research assistant
1055480|NCT00680368|O1|Outcome|Physician Residents and Attending Physicians|Sample included 112, including 60 physician residents and 37 attending physicians
1055481|NCT00680368|E1|Reported Event|Group 1|Sample included 75 resident physicians. No adverse events noted.
1055482|NCT00680225|B1|Baseline|Lucentis Injection|"Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.~Ranibizumab injection and TTT - ICG based: Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month."
1055483|NCT00680225|P1|Participant Flow|Lucentis Injection|"Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.~Ranibizumab injection and TTT - ICG based: Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month."
1055484|NCT00680225|O1|Outcome|Lucentis Injection|"Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.~Ranibizumab injection and TTT - ICG based: Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month."
1055485|NCT00680225|O1|Outcome|Lucentis Injection|"Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.~Ranibizumab injection and TTT - ICG based: Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month."
1055486|NCT00680225|E1|Reported Event|Lucentis Injection|"Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.~Ranibizumab injection and TTT - ICG based: Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month."
1055487|NCT00680186|B3|Baseline|Total|Total of all reporting groups
1055488|NCT00680186|B2|Baseline|Warfarin|PRN to maintain an INR of 2.0-3.0
1055489|NCT00680186|B1|Baseline|Dabigatran 150 mg|bid oral
1055490|NCT00680186|P2|Participant Flow|Warfarin|PRN (as needed) to maintain an INR (international normalised ratio) of 2.0-3.0
1055491|NCT00680186|P1|Participant Flow|Dabigatran 150 mg|bid (twice daily) oral
1055492|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
1055493|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
1055494|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
1055495|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
1055496|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
1055497|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
1055498|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
1055499|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
1055500|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
1055501|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
1055502|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
1055503|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
1055504|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
1055505|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
1055506|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
1055507|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
1055508|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
1055509|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
1055510|NCT00680186|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
1055511|NCT00680186|O1|Outcome|Dabigatran 150 mg|bid oral
1055512|NCT00680186|E2|Reported Event|Warfarin|PRN to maintain an INR of 2.0-3.0
1055513|NCT00680186|E1|Reported Event|Dabigatran 150 mg|bid oral
1055514|NCT00680121|B3|Baseline|Total|Total of all reporting groups
1055515|NCT00680121|B2|Baseline|Benfotiamine|Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
1055516|NCT00680121|B1|Baseline|Control Group|Placebo; identically matched to Benfotiamine capsules
1055517|NCT00680121|P2|Participant Flow|Benfotiamine|Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
1055518|NCT00680121|P1|Participant Flow|Control Group|Placebo; identically matched to Benfotiamine capsules
1055519|NCT00680121|O2|Outcome|Benfotiamine|Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
1055520|NCT00680121|O1|Outcome|Control Group|Placebo; identically matched to Benfotiamine capsules
1055521|NCT00680121|O2|Outcome|Benfotiamine|Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
1055522|NCT00680121|O1|Outcome|Control Group|Placebo; identically matched to Benfotiamine capsules
1055523|NCT00680121|O2|Outcome|Benfotiamine|Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
1055524|NCT00680121|O1|Outcome|Control Group|Placebo; identically matched to Benfotiamine capsules
1055525|NCT00680121|O2|Outcome|Benfotiamine|Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
1055526|NCT00680121|O1|Outcome|Control Group|Placebo; identically matched to Benfotiamine capsules
1055527|NCT00680121|E2|Reported Event|Benfotiamine|Benfotiamine 600 mg; 4 capsules taken once daily by mouth for 24 weeks
1055528|NCT00680121|E1|Reported Event|Control Group|Placebo; identically matched to Benfotiamine capsules
1055529|NCT00680056|B3|Baseline|Total|Total of all reporting groups
1055530|NCT00680056|B2|Baseline|Formoterol Plus Tiotropium First|Formoterol + Tiotropium in first intervention period and Formoterol + placebo in second intervention period (after washout period).
1055531|NCT00680056|B1|Baseline|Formoterol Plus Placebo (Tiotropium) First|Formoterol + Placebo (Tiotropium) in first intervention period and Formoterol + Tiotropium in second intervention period (after washout period).
1055532|NCT00680056|P2|Participant Flow|Formoterol Plus Tiotropium First|Formoterol + Tiotropium in first intervention period and Formoterol + placebo in second intervention period (after washout period).
1055533|NCT00680056|P1|Participant Flow|Formoterol Plus Placebo (Tiotropium) First|Formoterol + Placebo (Tiotropium) in first intervention period and Formoterol + Tiotropium in second intervention period (after washout period).
1055534|NCT00680056|O2|Outcome|Formoterol Plus Tiotropium Treatment|Formoterol + Tiotropium in first intervention period and Formoterol + placebo in second intervention period (after washout period).
1055535|NCT00680056|O1|Outcome|Formoterol Plus Placebo (Tiotropium) Treatment|Formoterol + Placebo (Tiotropium) in either first intervention period or second intervention period.
1055536|NCT00680056|O2|Outcome|Formoterol Plus Tiotropium Treatment|Formoterol + Tiotropium in either first intervention period or second intervention period.
1055537|NCT00680056|O1|Outcome|Formoterol Plus Placebo (Tiotropium) Treatment|Formoterol + Placebo (Tiotropium) in either first intervention period or second intervention period.
1055538|NCT00680056|E2|Reported Event|Formoterol Plus Tiotropium First|Formoterol + Tiotropium in first intervention period and Formoterol + placebo in second intervention period (after washout period).
1055539|NCT00680056|E1|Reported Event|Formoterol Plus Placebo (Tiotropium) First|Formoterol + Placebo (Tiotropium) in first intervention period and Formoterol + Tiotropium in second intervention period (after washout period).
1055540|NCT00680043|B4|Baseline|Total|Total of all reporting groups
1055541|NCT00680043|B3|Baseline|Epoetin Alfa|Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1055542|NCT00680043|B2|Baseline|Peginesatide 0.08 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1055543|NCT00680043|B1|Baseline|Peginesatide 0.04 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
1055544|NCT00680043|P3|Participant Flow|Epoetin Alfa|Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1055545|NCT00680043|P2|Participant Flow|Peginesatide 0.08 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1055546|NCT00680043|P1|Participant Flow|Peginesatide 0.04 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
1055547|NCT00680043|O3|Outcome|Epoetin Alfa|Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1055548|NCT00680043|O2|Outcome|Peginesatide 0.08 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1055549|NCT00680043|O1|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
1055550|NCT00680043|O3|Outcome|Epoetin Alfa|Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1055551|NCT00680043|O2|Outcome|Peginesatide 0.08 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1055552|NCT00680043|O1|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
1055553|NCT00680043|O3|Outcome|Epoetin Alfa|Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1055554|NCT00680043|O2|Outcome|Peginesatide 0.08 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1055555|NCT00680043|O1|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
1055806|NCT00679627|B3|Baseline|Total|Total of all reporting groups
1055556|NCT00680043|E3|Reported Event|Epoetin Alfa|Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1055557|NCT00680043|E2|Reported Event|Peginesatide 0.08 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1055558|NCT00680043|E1|Reported Event|Peginesatide 0.04 mg/kg|Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
1055559|NCT00680017|B3|Baseline|Total|Total of all reporting groups
1055560|NCT00680017|B2|Baseline|Rosuvastatin|Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
1055561|NCT00680017|B1|Baseline|ABT-335 Plus Rosuvastatin|ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
1055562|NCT00680017|P2|Participant Flow|Rosuvastatin|Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
1055563|NCT00680017|P1|Participant Flow|ABT-335 Plus Rosuvastatin|ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
1055564|NCT00680017|O2|Outcome|Rosuvastatin|Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
1055565|NCT00680017|O1|Outcome|ABT-335 Plus Rosuvastatin|ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
1055566|NCT00680017|O2|Outcome|Rosuvastatin|Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
1055567|NCT00680017|O1|Outcome|ABT-335 Plus Rosuvastatin|ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
1055568|NCT00680017|E2|Reported Event|Rosuvastatin|Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
1055569|NCT00680017|E1|Reported Event|ABT-335 Plus Rosuvastatin|ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
1055570|NCT00679952|B3|Baseline|Total|Total of all reporting groups
1055571|NCT00679952|B2|Baseline|Natural Drainage Group|natural drainage group (ND group)
1055572|NCT00679952|B1|Baseline|Closed Suction Drainage Group|closed suction drainage group (CD group)
1055573|NCT00679952|P2|Participant Flow|Natural Drainage Group|natural drainage group (ND group)
1055574|NCT00679952|P1|Participant Flow|Closed Suction Drainage Group|closed suction drainage group (CD group)
1055575|NCT00679952|O2|Outcome|Natural Drainage Group|natural drainage group (ND group)
1055576|NCT00679952|O1|Outcome|Closed Suction Drainage Group|closed suction drainage group (CD group)
1055577|NCT00679952|E2|Reported Event|Natural Drainage Group|natural drainage group (ND group)
1055578|NCT00679952|E1|Reported Event|Closed Suction Drainage Group|closed suction drainage group (CD group)
1055579|NCT00679939|B3|Baseline|Total|Total of all reporting groups
1055580|NCT00679939|B2|Baseline|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055581|NCT00679939|B1|Baseline|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055582|NCT00679939|P2|Participant Flow|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055583|NCT00679939|P1|Participant Flow|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055584|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055585|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055586|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1056022|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
1055587|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055588|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055589|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055590|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055591|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055592|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055593|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055594|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055595|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055596|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055597|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055598|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055599|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055600|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055601|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055602|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055603|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055604|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055605|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055606|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055607|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055608|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055609|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055610|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055611|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055612|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055613|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055614|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055615|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055616|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055617|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055618|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055619|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055620|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055621|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055622|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055623|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055624|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055625|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055626|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055627|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055628|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055629|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055630|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055631|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055632|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055633|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055634|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055635|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055636|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055637|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055638|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055639|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055640|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055641|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055642|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055643|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055644|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055645|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055646|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055647|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055648|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055649|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055650|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055651|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055652|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055653|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055654|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055655|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055656|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055657|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055658|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055659|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055660|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055661|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055662|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055663|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055664|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055665|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055666|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055667|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055668|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055669|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055670|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055671|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055672|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055673|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055674|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055675|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055676|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055677|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055678|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055679|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055680|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055681|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055682|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055683|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055684|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055685|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055686|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055687|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055688|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055689|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055690|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055691|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055692|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055693|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055694|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055695|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055696|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055697|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055698|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055699|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055700|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055701|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055702|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055703|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055704|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055705|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055706|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055707|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055708|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055709|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055710|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055711|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055712|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055713|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055714|NCT00679939|O2|Outcome|Metformin|Metformin (MET) initiated at a total daily dose of 1000 mg. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055715|NCT00679939|O1|Outcome|Rosiglitazone|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg). RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055716|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055717|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055718|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055719|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055720|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055721|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055722|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055723|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055724|NCT00679939|O2|Outcome|Metformin in DB Period; Metformin in OL Period|Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055725|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055726|NCT00679939|O1|Outcome|Rosiglitazone in DB Period; Metformin in OL Period|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1056023|NCT00678587|O1|Outcome|Placebo|Matching placebo
1055727|NCT00679939|E4|Reported Event|Metformin: MET OL|At Week 52, all participants receiving MET in the DB Period were switched to open-label MET therapy for 24 weeks during the OL Period; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055728|NCT00679939|E3|Reported Event|Rosiglitazone: MET OL|At Week 52, all participants receiving RSG in the DB Period were switched to open-label Metformin (MET) therapy for 24 weeks during the Open-label (OL) Period; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues.
1055729|NCT00679939|E2|Reported Event|Metformin: DB|Metformin (MET) initiated at a total daily dose of 1000 mg. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4 in the 52-week DB Period.
1055730|NCT00679939|E1|Reported Event|Rosiglitazone: DB|Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg). RSG could be uptitrated to a total daily dose of 8 mg at Week 4 in the 52-week Double-Blind (DB) Period.
1055731|NCT00679913|B3|Baseline|Total|Total of all reporting groups
1055732|NCT00679913|B2|Baseline|Extended Pancreatoduodenectomy|"extended pancreatoduodenectomy~Extended pancreatoduodenectomy: Extended pancreatoduodenectomy During extended resection, the lymph nodes around the common hepatic artery (LN 8), celiac axis (CA) (LN 9), peripancreatic area (LN 13, 17), hepatoduodenal ligament (LN 12), SMA (LN 14) and paraaortic area (LN16) between the CA and inferior mesenteric artery were dissected. All soft tissues around the hepatoduodenal ligament were completely dissected and skeletonized. The nerve plexus or ganglion on the right side of the CA and SMA was dissected semi-circumferentially."
1055733|NCT00679913|B1|Baseline|Standard Pancreatoduodenectomy|"standard pancreatoduodenectomy~Standard pancreatoduodenectomy: Standard pancreatoduodenectomy In standard resection, the lymph nodes around the pancreas head (LN 13, 17) and gallbladder (LN 12c) were removed without nerve dissection around the hepatic or superior mesenteric artery (SMA)."
1055734|NCT00679913|P2|Participant Flow|Extended Pancreatoduodenectomy|extended pancreatoduodenectomy Extended pancreatoduodenectomy: Extended pancreatoduodenectomy During extended resection, the lymph nodes around the common hepatic artery (LN 8), celiac axis (CA) (LN 9), peripancreatic area (LN 13, 17), hepatoduodenal ligament (LN 12), SMA (LN 14) and paraaortic area (LN16) between the CA and inferior mesenteric artery were dissected. All soft tissues around the hepatoduodenal ligament were completely dissected and skeletonized. The nerve plexus or ganglion on the right side of the CA and SMA was dissected semi-circumferentially.
1055735|NCT00679913|P1|Participant Flow|Standard Pancreatoduodenectomy|standard pancreatoduodenectomy Standard pancreatoduodenectomy: Standard pancreatoduodenectomy In standard resection, the lymph nodes around the pancreas head (LN 13, 17) and gallbladder (LN 12c) were removed without nerve dissection around the hepatic or superior mesenteric artery (SMA)
1055736|NCT00679913|O2|Outcome|Extended Pancreatoduodenectomy|"extended pancreatoduodenectomy~Extended pancreatoduodenectomy: Extended pancreatoduodenectomy During extended resection, the lymph nodes around the common hepatic artery (LN 8), celiac axis (CA) (LN 9), peripancreatic area (LN 13, 17), hepatoduodenal ligament (LN 12), SMA (LN 14) and paraaortic area (LN16) between the CA and inferior mesenteric artery were dissected. All soft tissues around the hepatoduodenal ligament were completely dissected and skeletonized"
1055737|NCT00679913|O1|Outcome|Standard Pancreatoduodenectomy|"standard pancreatoduodenectomy~Standard pancreatoduodenectomy: Standard pancreatoduodenectomy In standard resection, the lymph nodes around the pancreas head (LN 13, 17) and gallbladder (LN 12c) were removed without nerve dissection around the hepatic or superior mesenteric artery (SMA)."
1055738|NCT00679913|O2|Outcome|Extended Pancreatoduodenectomy|"extended pancreatoduodenectomy~Extended pancreatoduodenectomy: Extended pancreatoduodenectomy During extended resection, the lymph nodes around the common hepatic artery (LN 8), celiac axis (CA) (LN 9), peripancreatic area (LN 13, 17), hepatoduodenal ligament (LN 12), SMA (LN 14) and paraaortic area (LN16) between the CA and inferior mesenteric artery were dissected. All soft tissues around the hepatoduodenal ligament were completely dissected and skeletonized. The nerve plexus or ganglion on the right side of the CA and SMA was dissected semi-circumferentially."
1055739|NCT00679913|O1|Outcome|Standard Pancreatoduodenectomy|"standard pancreatoduodenectomy~Standard pancreatoduodenectomy: Standard pancreatoduodenectomy In standard resection, the lymph nodes around the pancreas head (LN 13, 17) and gallbladder (LN 12c) were removed without nerve dissection around the hepatic or superior mesenteric artery (SMA)."
1055740|NCT00679913|E2|Reported Event|Extended Pancreatoduodenectomy|"extended pancreatoduodenectomy~Extended pancreatoduodenectomy: Extended pancreatoduodenectomy During extended resection, the lymph nodes around the common hepatic artery (LN 8), celiac axis (CA) (LN 9), peripancreatic area (LN 13, 17), hepatoduodenal ligament (LN 12), SMA (LN 14) and paraaortic area (LN16) between the CA and inferior mesenteric artery were dissected. All soft tissues around the hepatoduodenal ligament were completely dissected and skeletonized."
1055741|NCT00679913|E1|Reported Event|Standard Pancreatoduodenectomy|"standard pancreatoduodenectomy~Standard pancreatoduodenectomy: Standard pancreatoduodenectomy In standard resection, the lymph nodes around the pancreas head (LN 13, 17) and gallbladder (LN 12c) were removed without nerve dissection around the hepatic or superior mesenteric artery (SMA)."
1055742|NCT00679783|B8|Baseline|Total|Total of all reporting groups
1055743|NCT00679783|B7|Baseline|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
1055744|NCT00679783|B6|Baseline|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
1055745|NCT00679783|B5|Baseline|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
1055746|NCT00679783|B4|Baseline|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
1055747|NCT00679783|B3|Baseline|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
1055927|NCT00679263|P3|Participant Flow|MN-221 2-hour Infusion|16 μg/min for 15 minutes + 8 μg/min for 105 minutes (2-hour infusion, total dose 1,080 μg) or placebo
1055748|NCT00679783|B2|Baseline|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
1055749|NCT00679783|B1|Baseline|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
1055750|NCT00679783|P7|Participant Flow|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
1055751|NCT00679783|P6|Participant Flow|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
1055752|NCT00679783|P5|Participant Flow|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
1055753|NCT00679783|P4|Participant Flow|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
1055754|NCT00679783|P3|Participant Flow|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
1055755|NCT00679783|P2|Participant Flow|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
1055756|NCT00679783|P1|Participant Flow|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
1055757|NCT00679783|O7|Outcome|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
1055758|NCT00679783|O6|Outcome|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
1055759|NCT00679783|O5|Outcome|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
1055760|NCT00679783|O4|Outcome|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
1055761|NCT00679783|O3|Outcome|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
1055762|NCT00679783|O2|Outcome|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
1055763|NCT00679783|O1|Outcome|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
1055764|NCT00679783|O7|Outcome|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
1055765|NCT00679783|O6|Outcome|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
1055766|NCT00679783|O5|Outcome|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
1055767|NCT00679783|O4|Outcome|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
1055768|NCT00679783|O3|Outcome|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
1055769|NCT00679783|O2|Outcome|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
1055770|NCT00679783|O1|Outcome|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
1055771|NCT00679783|O7|Outcome|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
1055772|NCT00679783|O6|Outcome|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
1055773|NCT00679783|O5|Outcome|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
1055774|NCT00679783|O4|Outcome|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
1055775|NCT00679783|O3|Outcome|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
1055776|NCT00679783|O2|Outcome|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
1063198|NCT00661492|O2|Outcome|Arm 2|Novantrone
1055777|NCT00679783|O1|Outcome|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
1055778|NCT00679783|O7|Outcome|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
1055779|NCT00679783|O6|Outcome|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
1055780|NCT00679783|O5|Outcome|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
1055781|NCT00679783|O4|Outcome|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
1055782|NCT00679783|O3|Outcome|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
1055783|NCT00679783|O2|Outcome|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
1055784|NCT00679783|O1|Outcome|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
1055785|NCT00679783|O7|Outcome|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
1055786|NCT00679783|O6|Outcome|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
1055787|NCT00679783|O5|Outcome|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
1055788|NCT00679783|O4|Outcome|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
1055789|NCT00679783|O3|Outcome|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
1055790|NCT00679783|O2|Outcome|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
1055791|NCT00679783|O1|Outcome|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
1055792|NCT00679783|O7|Outcome|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
1055793|NCT00679783|O6|Outcome|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
1055794|NCT00679783|O5|Outcome|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
1055795|NCT00679783|O4|Outcome|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
1055796|NCT00679783|O3|Outcome|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
1055797|NCT00679783|O2|Outcome|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
1055798|NCT00679783|O1|Outcome|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
1055799|NCT00679783|E7|Reported Event|BRCA Negative Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2."
1055800|NCT00679783|E6|Reported Event|BRCA Positive Triple Negative Breast|"Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)"
1055801|NCT00679783|E5|Reported Event|BRCA Positive Non-triple Negative Breast|"Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2"
1055802|NCT00679783|E4|Reported Event|BRCA Negative Serous Ovarian|"Patients with serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
1055803|NCT00679783|E3|Reported Event|BRCA Negative Non-serous Ovarian|"Patients with non-serous ovarian cancer who do not have a harmful mutation in the breast cancer genes BRCA1 or BRCA2"
1055804|NCT00679783|E2|Reported Event|BRCA Positive Serous Ovarian|"Patients with serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer)."
1055805|NCT00679783|E1|Reported Event|BRCA Positive Non-serous Ovarian|"Patients with non-serous ovarian cancer who have a harmful mutation in the breast cancer genes BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as non-serous in this study)."
1055807|NCT00679627|B2|Baseline|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
1055808|NCT00679627|B1|Baseline|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
1055809|NCT00679627|P2|Participant Flow|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
1055810|NCT00679627|P1|Participant Flow|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
1055811|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
1055812|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
1055813|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
1055814|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
1055815|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
1055816|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
1055817|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
1055818|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
1055819|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
1055820|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
1055821|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
1055928|NCT00679263|P2|Participant Flow|Placebo|MN-221 Placebo continuous infusion
1055929|NCT00679263|P1|Participant Flow|MN-221 1-hour Infusion|30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg)
1055822|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
1055823|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
1055824|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
1055825|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
1055826|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
1055827|NCT00679627|O2|Outcome|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
1055828|NCT00679627|O1|Outcome|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
1055829|NCT00679627|E2|Reported Event|Galantamine|During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator’s judgment and participant tolerability.
1055830|NCT00679627|E1|Reported Event|Placebo|During the titration and long-term maintenance periods, placebo was supplied as oral capsules matching galantamine capsules in size and appearance. The study drug was administered using the same titration and maintenance regimens as was used for participants in the galantamine treatment group.
1055831|NCT00679432|B5|Baseline|Total|Total of all reporting groups
1055832|NCT00679432|B4|Baseline|4: Asacol® 400 mg|"Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Asacol® 400 mg : 2400 mg/day, 400 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
1055833|NCT00679432|B3|Baseline|3: Placebo|"Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Placebo : Placebo~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
1055834|NCT00679432|B2|Baseline|2: Budesonide-MMX® 9 mg|"One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores~budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets"
1055835|NCT00679432|B1|Baseline|1: Budesonide-MMX® 6 mg|"One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
1055836|NCT00679432|P4|Participant Flow|4: Asacol® 400 mg|"Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Asacol® 400 mg : 2400 mg/day, 400 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
1055837|NCT00679432|P3|Participant Flow|3: Placebo|"Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Placebo : Placebo~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
1055838|NCT00679432|P2|Participant Flow|2: Budesonide-MMX® 9 mg|"One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores~budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets"
1055839|NCT00679432|P1|Participant Flow|1: Budesonide-MMX® 6 mg|"One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
1055840|NCT00679432|O4|Outcome|4: Asacol® 400 mg|"Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Asacol® 400 mg : 2400 mg/day, 400 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
1055841|NCT00679432|O3|Outcome|3: Placebo|"Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Placebo : Placebo~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
1055842|NCT00679432|O2|Outcome|2: Budesonide-MMX® 9 mg|"One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores~budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets"
1055843|NCT00679432|O1|Outcome|1: Budesonide-MMX® 6 mg|"One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
1055844|NCT00679432|O4|Outcome|4: Asacol® 400 mg|"Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Asacol® 400 mg : 2400 mg/day, 400 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
1055845|NCT00679432|O3|Outcome|3: Placebo|"Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Placebo : Placebo~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
1055846|NCT00679432|O2|Outcome|2: Budesonide-MMX® 9 mg|"One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores~budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets"
1055847|NCT00679432|O1|Outcome|1: Budesonide-MMX® 6 mg|"One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
1055848|NCT00679432|O4|Outcome|4: Asacol® 400 mg|"Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Asacol® 400 mg : 2400 mg/day, 400 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
1055849|NCT00679432|O3|Outcome|3: Placebo|"Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Placebo : Placebo~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
1055850|NCT00679432|O2|Outcome|2: Budesonide-MMX® 9 mg|"One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores~budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets"
1055851|NCT00679432|O1|Outcome|1: Budesonide-MMX® 6 mg|"One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
1055852|NCT00679432|E4|Reported Event|4: Asacol® 400 mg|"Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Asacol® 400 mg : 2400 mg/day, 400 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
1055853|NCT00679432|E3|Reported Event|3: Placebo|"Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Placebo : Placebo~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
1055854|NCT00679432|E2|Reported Event|2: Budesonide-MMX® 9 mg|"One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores~budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets"
1055855|NCT00679432|E1|Reported Event|1: Budesonide-MMX® 6 mg|"One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.~budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets~Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores"
1055856|NCT00679380|B5|Baseline|Total|Total of all reporting groups
1055857|NCT00679380|B4|Baseline|4: Placebo|Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
1055858|NCT00679380|B3|Baseline|3: Entocort EC® 3 mg|Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
1055859|NCT00679380|B2|Baseline|2: Budesonide-MMX® 9 mg|One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
1055860|NCT00679380|B1|Baseline|1: Budesonide-MMX® 6 mg|One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
1055861|NCT00679380|P4|Participant Flow|4: Placebo|Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
1055862|NCT00679380|P3|Participant Flow|3: Entocort EC® 3 mg|Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
1055863|NCT00679380|P2|Participant Flow|2: Budesonide-MMX® 9 mg|One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
1055864|NCT00679380|P1|Participant Flow|1: Budesonide-MMX® 6 mg|One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
1055865|NCT00679380|O4|Outcome|4: Placebo|Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
1055866|NCT00679380|O3|Outcome|3: Entocort EC® 3 mg|Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
1055867|NCT00679380|O2|Outcome|2: Budesonide-MMX® 9 mg|One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
1055868|NCT00679380|O1|Outcome|1: Budesonide-MMX® 6 mg|One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
1055869|NCT00679380|O4|Outcome|4: Placebo|Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
1055870|NCT00679380|O3|Outcome|3: Entocort EC® 3 mg|Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
1055871|NCT00679380|O2|Outcome|2: Budesonide-MMX® 9 mg|One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
1055872|NCT00679380|O1|Outcome|1: Budesonide-MMX® 6 mg|One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
1055873|NCT00679380|O4|Outcome|4: Placebo|Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
1055874|NCT00679380|O3|Outcome|3: Entocort EC® 3 mg|Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
1055875|NCT00679380|O2|Outcome|2: Budesonide-MMX® 9 mg|One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
1055876|NCT00679380|O1|Outcome|1: Budesonide-MMX® 6 mg|One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
1055877|NCT00679380|E4|Reported Event|4: Placebo|Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
1055878|NCT00679380|E3|Reported Event|3: Entocort EC® 3 mg|Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
1055879|NCT00679380|E2|Reported Event|2: Budesonide-MMX® 9 mg|One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
1055880|NCT00679380|E1|Reported Event|1: Budesonide-MMX® 6 mg|One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
1055881|NCT00679367|B1|Baseline|Melphalan Revlimid and Dexamethasone|"Melphalan Lenalidomide Dexamethasone~dexamethasone: 40 mg once weekly~lenalidomide: 10 mg/day Days 1-21~melphalan: 5 mg/m2 Days 1-4"
1055882|NCT00679367|P1|Participant Flow|Melphalan Revlimid and Dexamethasone|"Melphalan Lenalidomide Dexamethasone~dexamethasone: 40 mg once weekly~lenalidomide: 10 mg/day Days 1-21~melphalan: 5 mg/m2 Days 1-4"
1055883|NCT00679367|O1|Outcome|Melphalan Revlimid and Dexamethasone|"Melphalan Lenalidomide Dexamethasone~dexamethasone: 40 mg once weekly~lenalidomide: 10 mg/day days 1-21~melphalan: 5 mg/m2 days 1-4"
1055884|NCT00679367|O1|Outcome|Melphalan Revlimid and Dexamethasone|"Melphalan Lenalidomide Dexamethasone~dexamethasone: 40 mg once weekly~lenalidomide: 10 mg/day Days 1-21~melphalan: 5 mg/m2 Days 1-4"
1055885|NCT00679367|O1|Outcome|Melphalan Revlimid and Dexamethasone|"Melphalan Lenalidomide Dexamethasone~dexamethasone: 40 mg once weekly~lenalidomide: 10 mg/day Days 1-21~melphalan: 5 mg/m2 Days 1-4"
1055886|NCT00679367|E1|Reported Event|Melphalan Revlimid and Dexamethasone|"Melphalan Lenalidomide Dexamethasone~dexamethasone: 40 mg once weekly~lenalidomide: 10 mg/day Days 1-21~melphalan: 5 mg/m2 Days 1-4"
1055887|NCT00679354|B1|Baseline|Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour (1800 mg/m2/dose, maximum 75mg/kg) on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1055888|NCT00679354|P1|Participant Flow|Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour (1800 mg/m2/dose, maximum 75mg/kg) on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1055930|NCT00679263|O3|Outcome|MN-221 2-hour Infusion|16 μg/min for 15 minutes + 8 μg/min for 105 minutes (2-hour infusion, total dose 1,080 μg) or placebo
1055889|NCT00679354|O1|Outcome|Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour (1800 mg/m2/dose, maximum 75mg/kg) on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1055890|NCT00679354|E1|Reported Event|Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour (1800 mg/m2/dose, maximum 75mg/kg) on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1055891|NCT00679341|B3|Baseline|Total|Total of all reporting groups
1055892|NCT00679341|B2|Baseline|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
1055893|NCT00679341|B1|Baseline|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
1055894|NCT00679341|P2|Participant Flow|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
1055895|NCT00679341|P1|Participant Flow|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
1055896|NCT00679341|O1|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
1055897|NCT00679341|O1|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
1055898|NCT00679341|O2|Outcome|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
1055899|NCT00679341|O1|Outcome|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
1055900|NCT00679341|O2|Outcome|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
1055901|NCT00679341|O1|Outcome|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
1055902|NCT00679341|O2|Outcome|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
1055903|NCT00679341|O1|Outcome|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
1055904|NCT00679341|O2|Outcome|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
1055905|NCT00679341|O1|Outcome|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
1055906|NCT00679341|O2|Outcome|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
1055907|NCT00679341|O1|Outcome|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
1055908|NCT00679341|O2|Outcome|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
1055909|NCT00679341|O1|Outcome|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
1055910|NCT00679341|E2|Reported Event|Trastuzumab + Docetaxel|Patients received a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
1055911|NCT00679341|E1|Reported Event|Trastuzumab Emtansine|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
1055912|NCT00679302|B3|Baseline|Total|Total of all reporting groups
1055913|NCT00679302|B2|Baseline|Antibiotic Group|Trimethoprim-sulfamethoxazole suspension
1055914|NCT00679302|B1|Baseline|Placebo Group|Maalox and bitter mixture
1055915|NCT00679302|P2|Participant Flow|Antibiotic Group|Trimethoprim-sulfamethoxazole suspension
1055916|NCT00679302|P1|Participant Flow|Placebo Group|Maalox and bitter mixture
1055917|NCT00679302|O2|Outcome|Antibiotic Group|Trimethoprim-sulfamethoxazole suspension
1055918|NCT00679302|O1|Outcome|Placebo Group|Maalox and bitter mixture
1055919|NCT00679302|O2|Outcome|Antibiotic Group|Trimethoprim-sulfamethoxazole suspension
1055920|NCT00679302|O1|Outcome|Placebo Group|Maalox and bitter mixture
1055921|NCT00679302|E2|Reported Event|Antibiotic Group|Trimethoprim-sulfamethoxazole suspension
1055922|NCT00679302|E1|Reported Event|Placebo Group|Maalox and bitter mixture
1055923|NCT00679263|B4|Baseline|Total|Total of all reporting groups
1055924|NCT00679263|B3|Baseline|MN-221 2-hour Infusion|16 μg/min for 15 minutes + 8 μg/min for 105 minutes (2-hour infusion, total dose 1,080 μg) or placebo
1055925|NCT00679263|B2|Baseline|Placebo|MN-221 Placebo continuous infusion
1055926|NCT00679263|B1|Baseline|MN-221 1-hour Infusion|30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg)
1055932|NCT00679263|O1|Outcome|MN-221 1-hour Infusion|30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg)
1055933|NCT00679263|O3|Outcome|MN-221 2-hour Infusion|16 μg/min for 15 minutes + 8 μg/min for 105 minutes (2-hour infusion, total dose 1,080 μg) or placebo
1055934|NCT00679263|O2|Outcome|Placebo|MN-221 Placebo continuous infusion
1055935|NCT00679263|O1|Outcome|MN-221 1-hour Infusion|30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg)
1055936|NCT00679263|E3|Reported Event|MN-221 2-hour Infusion|16 μg/min for 15 minutes + 8 μg/min for 105 minutes (2-hour infusion, total dose 1,080 μg) or placebo
1055937|NCT00679263|E2|Reported Event|Placebo|MN-221 Placebo continuous infusion
1055938|NCT00679263|E1|Reported Event|MN-221 1-hour Infusion|30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg)
1055939|NCT00678899|B1|Baseline|Surgery|Implantation with the Nucleus Hybrid L24 Cochlear Implant
1055940|NCT00678899|P1|Participant Flow|6 Months Post Activation|Subjects implanted with the Hybrid L implant who completed the primary endpoint of 6 months postactivation
1055941|NCT00678899|O1|Outcome|6 Months Post Activation|Subjects implanted with the Hybrid L implant who completed the primary endpoint of 6 months postactivation
1055942|NCT00678899|O1|Outcome|6 Months Post Activation|Subjects implanted with the Hybrid L implant who completed the primary endpoint of 6 months postactivation
1055943|NCT00678899|O1|Outcome|6 Months Post Activation|Subjects implanted with the Hybrid L implant who completed the primary endpoint of 6 months postactivation
1055944|NCT00678899|O1|Outcome|6 Months Postactivation|Subjects implanted with the Hybrid L implant who completed the primary endpoint of 6 months postactivation
1055945|NCT00678899|E1|Reported Event|Surgery|Implantation with the Nucleus Hybrid L24 Cochlear Implant
1055946|NCT00678834|B4|Baseline|Total|Total of all reporting groups
1055947|NCT00678834|B3|Baseline|Arm 3- Healthy + Tocotrienol 200 mg|Healthy Subjects will recieve either Tocotrienol: 200mg (two 100mg capsules) to take twice daily by mouth to make a total of 400mg per day
1055948|NCT00678834|B2|Baseline|Arm 2 - Surgical + Tocopherol 200 mg|Surgical Subjects will recieve Tocopherol: 200mg (two 100mg capsules) to take twice daily by mouth to make a total of 400mg per day
1055949|NCT00678834|B1|Baseline|Arm 1- Surgical + Tocotrienol 200 mg|Surgical Subjects will recieve either Tocotrienol: 200mg (two 100mg capsules) to take twice daily by mouth to make a total of 400mg per day
1055950|NCT00678834|P3|Participant Flow|Arm 3- Healthy +Tocotrienol 400 mg|Healthy patients to take Tocotrienol: 400 mg to take orally (two 200 mg capsules) two times a day.
1055951|NCT00678834|P2|Participant Flow|Arm 2- Surgery + Tocopherol 200 mg|Surgery Patients to take Tocopherol capsules.: 200mg (two 100mg capsules) taken by mouth twice to total 400mg daily
1055952|NCT00678834|P1|Participant Flow|Arm 1- Surgery + Tocotrienol 200 mg|Surgery Patients to take Tocotrienol capsules.: 200mg (two 100mg capsules) taken by mouth twice to total 400mg daily
1055953|NCT00678834|O13|Outcome|Arm 3: Healthy, Blood, Week 12|Blood levels of aTE after 12 weeks of supplementation (400mg/d)
1055954|NCT00678834|O12|Outcome|Arm 3: Healthy, Skin, Week 0|baseline skin levels of aTE prior to supplementation
1055955|NCT00678834|O11|Outcome|Arm 3: Healthy, Skin, Week 12|skin levels of aTE after 12 weeks of supplementation (400mg/d)
1055956|NCT00678834|O10|Outcome|Arm 3: Healthy, Blood, Week 6|Blood levels of aTE after 6 weeks of supplementation (400mg/d)
1055957|NCT00678834|O9|Outcome|Arm 3: Healthy, Blood, Week 0|Baseline blood levels of aTE prior to supplementation
1055958|NCT00678834|O8|Outcome|Arm 2: Surgical, Liver|liver aTCP levels after supplementation (400mg/d)
1055959|NCT00678834|O7|Outcome|Arm 2: Surgical, Heart|heart aTCP levels after supplementation (400mg/d)
1055960|NCT00678834|O6|Outcome|Arm 2: Surgical, Brain|brain aTCP levels after supplementation (400mg/d)
1055961|NCT00678834|O5|Outcome|Arm 2: Surgical, Adipose|adipose aTCP levels after supplementation (400mg/d)
1055962|NCT00678834|O4|Outcome|Arm 1: Surgical, Liver|liver aTE levels after supplementation (400mg/d)
1055963|NCT00678834|O3|Outcome|Arm 1: Surgical, Heart|heart aTE levels after supplementation (400mg/d)
1055964|NCT00678834|O2|Outcome|Arm 1: Surgical, Brain|brain aTE levels after supplementation (400mg/d)
1055965|NCT00678834|O1|Outcome|Arm 1: Surgical, Adipose|adipose aTE levels after supplementation (400mg/d)
1055966|NCT00678834|E3|Reported Event|Arm 3|Healthy patients to take either Tocotrienol or Tocopherol: 200mg (two 100mg capsules)taken by mouth twice with foold to make a total of 400mg daily
1055967|NCT00678834|E2|Reported Event|Arm 2|Surgery patients to take Tocopherol capsules.: 200mg (two 100mg capsules)taken by mouth twice with foold to make a total of 400mg daily
1055968|NCT00678834|E1|Reported Event|Arm 1|Surgery patients to take Tocotrienol capsules.: 200mg (two 100mg capsules)taken by mouth twice with foold to make a total of 400mg daily
1055969|NCT00678795|B3|Baseline|Total|Total of all reporting groups
1055970|NCT00678795|B2|Baseline|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
1055971|NCT00678795|B1|Baseline|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
1055972|NCT00678795|P2|Participant Flow|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
1055973|NCT00678795|P1|Participant Flow|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
1055974|NCT00678795|O2|Outcome|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
1055975|NCT00678795|O1|Outcome|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
1055976|NCT00678795|O2|Outcome|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
1056024|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
1055977|NCT00678795|O1|Outcome|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
1055978|NCT00678795|O2|Outcome|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
1055979|NCT00678795|O1|Outcome|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
1055980|NCT00678795|O2|Outcome|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
1055981|NCT00678795|O1|Outcome|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
1055982|NCT00678795|O2|Outcome|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
1055983|NCT00678795|O1|Outcome|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
1055984|NCT00678795|O2|Outcome|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
1055985|NCT00678795|O1|Outcome|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
1055986|NCT00678795|O2|Outcome|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
1055987|NCT00678795|O1|Outcome|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
1055988|NCT00678795|O2|Outcome|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
1055989|NCT00678795|O1|Outcome|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
1055990|NCT00678795|E2|Reported Event|Placebo|Each 100 ul actuation contains the colorants plus excipients. A maximum of 48 actuations was permitted in any 24 hour period.
1055991|NCT00678795|E1|Reported Event|Sativex|Each 100 ul actuation contains 27 mg delta-9-tetrahydrocannabinol (THC) and 25 mg cannabidiol (CBD). A maximum of 48 actuations (130 mg of THC and 120 mg of CBD) was permitted in any 24 hour period.
1055992|NCT00678691|B3|Baseline|Total|Total of all reporting groups
1055993|NCT00678691|B2|Baseline|A,2 Matching Placebo|placebo
1055994|NCT00678691|B1|Baseline|A,1 Armodafinil Study Drug|armodafinil
1055995|NCT00678691|P2|Participant Flow|A,2 Matching Placebo|placebo
1055996|NCT00678691|P1|Participant Flow|A,1 Armodafinil Study Drug 50-250mg Flexible Dose|armodafinil
1055997|NCT00678691|O2|Outcome|A,2 Matching Placebo|placebo
1055998|NCT00678691|O1|Outcome|A,1 Armodafinil Study Drug|armodafinil
1055999|NCT00678691|E2|Reported Event|A,2 Matching Placebo|placebo
1056000|NCT00678691|E1|Reported Event|A,1 Armodafinil Study Drug|armodafinil
1056001|NCT00678639|B3|Baseline|Total|Total of all reporting groups
1056002|NCT00678639|B2|Baseline|Usual Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
1056003|NCT00678639|B1|Baseline|Emergency Department (ED) Observation Unit|Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
1056004|NCT00678639|P2|Participant Flow|Usual Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
1056005|NCT00678639|P1|Participant Flow|Emergency Department (ED) Observation Unit|Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
1056006|NCT00678639|O2|Outcome|Usual Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
1056007|NCT00678639|O1|Outcome|Emergency Department (ED) Observation Unit|Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
1056008|NCT00678639|O2|Outcome|Usual Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
1056009|NCT00678639|O1|Outcome|Emergency Department (ED) Observation Unit|Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
1056010|NCT00678639|O1|Outcome|Emergency Department (ED) Observation Unit|Emergency Department observation unit- Cardiac MRI Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
1056011|NCT00678639|O2|Outcome|Usual Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
1056012|NCT00678639|O1|Outcome|Emergency Department (ED) Observation Unit|Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
1056013|NCT00678639|O2|Outcome|Usual Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
1056014|NCT00678639|O1|Outcome|Emergency Department (ED) Observation Unit|Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
1056015|NCT00678639|E2|Reported Event|Usual Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
1056016|NCT00678639|E1|Reported Event|Emergency Department (ED) Observation Unit|Emergency Department observation unit - Cardiac Magnetic Resonance Imaging (MRI) Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
1056017|NCT00678587|B3|Baseline|Total|Total of all reporting groups
1056025|NCT00678587|O1|Outcome|Placebo|Matching placebo
1056027|NCT00678587|O1|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
1056028|NCT00678587|O1|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
1056029|NCT00678587|O1|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
1056030|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
1056031|NCT00678587|O1|Outcome|Placebo|Matching placebo
1056032|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
1056033|NCT00678587|O1|Outcome|Placebo|Matching placebo
1056034|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
1056035|NCT00678587|O1|Outcome|Placebo|Matching placebo
1056036|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
1056037|NCT00678587|O1|Outcome|Placebo|Matching placebo
1056038|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
1056039|NCT00678587|O1|Outcome|Placebo|Matching placebo
1056040|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
1056041|NCT00678587|O1|Outcome|Placebo|Matching placebo
1056042|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
1056043|NCT00678587|O1|Outcome|Placebo|Matching placebo
1056044|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
1056045|NCT00678587|O1|Outcome|Placebo|Matching placebo
1056046|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
1056047|NCT00678587|O1|Outcome|Placebo|Matching placebo
1056048|NCT00678587|O2|Outcome|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
1056049|NCT00678587|O1|Outcome|Placebo|Matching placebo
1056050|NCT00678587|E2|Reported Event|Eltrombopag 75 mg|Eltrombopag 75 mg administered orally once daily
1056051|NCT00678587|E1|Reported Event|Placebo|Matching placebo
1056052|NCT00678535|B3|Baseline|Total|Total of all reporting groups
1056053|NCT00678535|B2|Baseline|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
1056054|NCT00678535|B1|Baseline|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
1056055|NCT00678535|P2|Participant Flow|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
1056056|NCT00678535|P1|Participant Flow|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
1056057|NCT00678535|O2|Outcome|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
1056058|NCT00678535|O1|Outcome|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
1056059|NCT00678535|O2|Outcome|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
1056060|NCT00678535|O1|Outcome|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
1056061|NCT00678535|O2|Outcome|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
1056062|NCT00678535|O1|Outcome|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
1056063|NCT00678535|O2|Outcome|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
1056064|NCT00678535|O1|Outcome|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
1056065|NCT00678535|O2|Outcome|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
1056102|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
1056103|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
1057072|NCT00675987|P2|Participant Flow|Placebo 1 Tab po QD|Placebo 1 tab po QD
1056066|NCT00678535|O1|Outcome|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
1056067|NCT00678535|O2|Outcome|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
1056068|NCT00678535|O1|Outcome|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
1056069|NCT00678535|E2|Reported Event|Capecitabine Plus Cisplatin|Cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
1056070|NCT00678535|E1|Reported Event|Cetuximab Plus Capecitabine Plus Cisplatin|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] followed by 250 mg/m^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent.
1056071|NCT00678470|B1|Baseline|Intralesional Alefacept|"Investigational intervention without random assignment~Intralesional Alefacept : Patients enrolled in this study will receive intralesional alefacept injections once a week for 3 weeks in three different lesions. Each lesion will only be injected once with one alefacept concentration. The week it is administered will depend on the concentration. Three different concentrations of the alefacept preparation will be administered."
1056072|NCT00678470|P1|Participant Flow|Intralesional Alefacept|"Investigational intervention without random assignment~Intralesional Alefacept : Patients enrolled in this study will receive intralesional alefacept injections once a week for 3 weeks in three different lesions. Each lesion will only be injected once with one alefacept concentration. The week it is administered will depend on the concentration. Three different concentrations of the alefacept preparation will be administered."
1056073|NCT00678470|O1|Outcome|Intralesional Alefacept Followed by Intramuscular Alefacept.|"Investigational intervention without random assignment~Intralesional Alefacept : Patients enrolled in this study will receive intralesional alefacept injections to a single plaque (week 0). The plaques will be scored for response to intralesional injection (week 2). All patients will then receive intramuscular injection (week 2). The patients will then be scored for response to intramuscular injection (week 14). The number of patients who responded to both intralesional and intramuscular injection will be tabulated."
1056074|NCT00678470|E1|Reported Event|Intralesional Alefacept|"Investigational intervention without random assignment~Intralesional Alefacept : Patients enrolled in this study will receive intralesional alefacept injections once a week for 3 weeks in three different lesions. Each lesion will only be injected once with one alefacept concentration. The week it is administered will depend on the concentration. Three different concentrations of the alefacept preparation will be administered."
1056075|NCT00678418|B3|Baseline|Total|Total of all reporting groups
1056076|NCT00678418|B2|Baseline|Placebo|Single intramuscular (IM) injection administered every 4 weeks
1056077|NCT00678418|B1|Baseline|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
1056078|NCT00678418|P2|Participant Flow|Placebo|Single intramuscular (IM) injection administered every 4 weeks
1056079|NCT00678418|P1|Participant Flow|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
1056080|NCT00678418|O2|Outcome|Placebo|Single intramuscular (IM) injection administered every 4 weeks
1056081|NCT00678418|O1|Outcome|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
1056082|NCT00678418|O2|Outcome|Placebo|Single intramuscular (IM) injection administered every 4 weeks
1056083|NCT00678418|O1|Outcome|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
1056084|NCT00678418|O2|Outcome|Placebo|Single intramuscular (IM) injection administered every 4 weeks
1056085|NCT00678418|O1|Outcome|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
1056086|NCT00678418|O2|Outcome|Placebo|Single intramuscular (IM) injection administered every 4 weeks
1056087|NCT00678418|O1|Outcome|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
1056088|NCT00678418|O2|Outcome|Placebo|Single intramuscular (IM) injection administered every 4 weeks
1056089|NCT00678418|O1|Outcome|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
1056090|NCT00678418|E2|Reported Event|Placebo|Single intramuscular (IM) injection administered every 4 weeks
1056091|NCT00678418|E1|Reported Event|VIVITROL® 380 mg|Single intramuscular (IM) injection administered every 4 weeks
1056092|NCT00678392|B3|Baseline|Total|Total of all reporting groups
1056093|NCT00678392|B2|Baseline|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
1056094|NCT00678392|B1|Baseline|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
1056095|NCT00678392|P2|Participant Flow|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
1056096|NCT00678392|P1|Participant Flow|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
1056097|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
1056098|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
1056099|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
1056100|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
1056101|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
1056104|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
1056105|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
1056106|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
1056107|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
1056108|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
1056109|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
1056110|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
1056111|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
1056112|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
1056113|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
1056114|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
1056115|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
1056116|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
1056117|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
1056118|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
1056119|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
1056120|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
1056121|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
1056122|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
1056123|NCT00678392|O2|Outcome|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
1056124|NCT00678392|O1|Outcome|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
1056125|NCT00678392|E2|Reported Event|Sorafenib 400 mg|Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
1056126|NCT00678392|E1|Reported Event|Axitinib 5 mg|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
1056127|NCT00678288|B3|Baseline|Total|Total of all reporting groups
1056128|NCT00678288|B2|Baseline|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
1056129|NCT00678288|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
1056130|NCT00678288|P2|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
1056131|NCT00678288|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
1056132|NCT00678288|O2|Outcome|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
1056133|NCT00678288|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
1056134|NCT00678288|O2|Outcome|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
1056135|NCT00678288|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
1056136|NCT00678288|O2|Outcome|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
1056137|NCT00678288|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
1056138|NCT00678288|O2|Outcome|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
1056139|NCT00678288|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
1056140|NCT00678288|O2|Outcome|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
1056141|NCT00678288|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
1056189|NCT00678210|P1|Participant Flow|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 milligram (mg) orally twice daily for 12 weeks.
1056142|NCT00678288|E2|Reported Event|Sorafenib (Nexavar, BAY43-9006) + Interferon|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
1056143|NCT00678288|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
1056144|NCT00678249|B4|Baseline|Total|Total of all reporting groups
1056145|NCT00678249|B3|Baseline|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
1056146|NCT00678249|B2|Baseline|PTA Only|Percutaneous Transluminal Angioplasty
1056147|NCT00678249|B1|Baseline|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
1056148|NCT00678249|P3|Participant Flow|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
1056149|NCT00678249|P2|Participant Flow|PTA Only|Percutaneous Transluminal Angioplasty
1056150|NCT00678249|P1|Participant Flow|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
1056151|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
1056152|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
1056153|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
1056154|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
1056155|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
1056156|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
1056157|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
1056158|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
1056159|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
1056160|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
1056161|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
1056162|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
1056163|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
1056164|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
1056165|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
1056166|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
1056167|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
1056168|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
1056169|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
1056170|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
1056171|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
1056172|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
1056173|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
1056174|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
1056175|NCT00678249|O3|Outcome|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
1056176|NCT00678249|O2|Outcome|PTA Only|Percutaneous Transluminal Angioplasty
1056177|NCT00678249|O1|Outcome|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
1056178|NCT00678249|E3|Reported Event|FLAIR Roll-In Participants|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft. Roll-in participants were enrolled in the study for training purposes and were not randomized.
1056179|NCT00678249|E2|Reported Event|PTA Only|Percutaneous Transluminal Angioplasty
1056180|NCT00678249|E1|Reported Event|FLAIR|Primary PTA followed by placement of the FLAIR Endovascular Stent Graft
1056181|NCT00678210|B5|Baseline|Total|Total of all reporting groups
1056182|NCT00678210|B4|Baseline|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
1056183|NCT00678210|B3|Baseline|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
1056184|NCT00678210|B2|Baseline|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
1056185|NCT00678210|B1|Baseline|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
1056186|NCT00678210|P4|Participant Flow|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
1056187|NCT00678210|P3|Participant Flow|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
1056188|NCT00678210|P2|Participant Flow|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
1056190|NCT00678210|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
1056191|NCT00678210|O3|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
1056192|NCT00678210|O2|Outcome|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
1056193|NCT00678210|O1|Outcome|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
1056194|NCT00678210|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
1056195|NCT00678210|O3|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
1056196|NCT00678210|O2|Outcome|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
1056197|NCT00678210|O1|Outcome|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
1056198|NCT00678210|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
1056199|NCT00678210|O3|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
1056200|NCT00678210|O2|Outcome|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
1056201|NCT00678210|O1|Outcome|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
1056202|NCT00678210|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
1056203|NCT00678210|O3|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
1056204|NCT00678210|O2|Outcome|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
1056205|NCT00678210|O1|Outcome|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
1056206|NCT00678210|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
1056207|NCT00678210|O3|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
1056208|NCT00678210|O2|Outcome|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
1056209|NCT00678210|O1|Outcome|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
1056210|NCT00678210|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
1056211|NCT00678210|O3|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
1056212|NCT00678210|O2|Outcome|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
1056213|NCT00678210|O1|Outcome|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
1056214|NCT00678210|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
1056215|NCT00678210|O3|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
1056216|NCT00678210|O2|Outcome|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
1056217|NCT00678210|O1|Outcome|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
1056218|NCT00678210|E4|Reported Event|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 12 weeks.
1056219|NCT00678210|E3|Reported Event|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 12 weeks.
1056220|NCT00678210|E2|Reported Event|CP-690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 mg orally twice daily for 12 weeks.
1056221|NCT00678210|E1|Reported Event|CP-690,550 2 mg|CP-690,550 tablets equivalent to CP-690,550 2 mg orally twice daily for 12 weeks.
1056222|NCT00678041|B3|Baseline|Total|Total of all reporting groups
1056223|NCT00678041|B2|Baseline|Arm 2: Placebo Group|"identical appearing placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC~Placebo: Placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC"
1056224|NCT00678041|B1|Baseline|Arm 1: Nitrofurantoin Group|"extended release nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC~Nitrofurantoin: nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC"
1056225|NCT00678041|P2|Participant Flow|Arm 2: Placebo Group|"identical appearing placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC~Placebo: Placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC"
1056226|NCT00678041|P1|Participant Flow|Arm 1: Nitrofurantoin Group|"extended release nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC~Nitrofurantoin: nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC"
1056227|NCT00678041|O1|Outcome|All Patients|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
1056228|NCT00678041|O1|Outcome|All Patients|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
1056229|NCT00678041|O1|Outcome|All Patients|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
1056230|NCT00678041|O1|Outcome|All Patients|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
1056231|NCT00678041|O1|Outcome|All Patients|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
1056232|NCT00678041|O1|Outcome|All Patients|0 participants analyzed due to study termination. Study terminated prior to accumulation of any data. Participating subjects were withdrawn prior to measuring any outcome data.
1056233|NCT00678041|O2|Outcome|Arm 2: Placebo Group|"identical appearing placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC~Placebo: Placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC"
1056442|NCT00677352|B3|Baseline|Total|Total of all reporting groups
1063199|NCT00661492|O1|Outcome|Arm 1|Novantrone+Erbitux
1056234|NCT00678041|O1|Outcome|Arm 1: Nitrofurantoin Group|"extended release nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC~Nitrofurantoin: nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC"
1056235|NCT00678041|E2|Reported Event|Arm 2: Placebo Group|"identical appearing placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC~Placebo: Placebo capsule to be taken daily while performing CISC and for three more days after stopping CISC"
1056236|NCT00678041|E1|Reported Event|Arm 1: Nitrofurantoin Group|"extended release nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC~Nitrofurantoin: nitrofurantoin 100mg to be taken daily while performing CISC and for three more days after stopping CISC"
1056237|NCT00678015|B1|Baseline|NDGA|Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.
1056238|NCT00678015|P1|Participant Flow|NDGA|Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.
1056239|NCT00678015|O1|Outcome|NDGA|Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.
1056240|NCT00678015|O1|Outcome|NDGA|Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.
1056241|NCT00678015|O1|Outcome|NDGA|Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.
1056242|NCT00678015|O1|Outcome|NDGA|Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.
1056243|NCT00678015|E1|Reported Event|NDGA|Nordihydroguaiaretic Acid (NDGA) 2000mg given orally daily in 3 divided doses (750mg in the morning and in the evening, and 500mg at midday) over a 28-day cycle.
1056244|NCT00677924|B3|Baseline|Total|Total of all reporting groups
1056245|NCT00677924|B2|Baseline|Zalutumumab 16 mg/kg|
1056246|NCT00677924|B1|Baseline|Zalatumumab 8 mg/kg|
1056247|NCT00677924|P2|Participant Flow|Zalutumumab 16 mg/kg|
1056248|NCT00677924|P1|Participant Flow|Zalatumumab 8 mg/kg|
1056249|NCT00677924|O2|Outcome|Zalutumumab 16 mg/kg|
1056250|NCT00677924|O1|Outcome|Zalatumumab 8 mg/kg|
1056251|NCT00677924|O2|Outcome|Zalutumumab 16 mg/kg|
1056252|NCT00677924|O1|Outcome|Zalatumumab 8 mg/kg|
1056253|NCT00677924|E2|Reported Event|Zalutumumab 16 mg/kg|
1056254|NCT00677924|E1|Reported Event|Zalatumumab 8 mg/kg|
1056255|NCT00677898|B3|Baseline|Total|Total of all reporting groups
1056256|NCT00677898|B2|Baseline|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
1056257|NCT00677898|B1|Baseline|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
1056258|NCT00677898|P2|Participant Flow|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
1056259|NCT00677898|P1|Participant Flow|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
1056260|NCT00677898|O2|Outcome|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
1056261|NCT00677898|O1|Outcome|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
1056262|NCT00677898|O2|Outcome|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
1056263|NCT00677898|O1|Outcome|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
1056264|NCT00677898|O2|Outcome|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
1056265|NCT00677898|O1|Outcome|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
1056266|NCT00677898|O2|Outcome|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
1056267|NCT00677898|O1|Outcome|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
1056268|NCT00677898|O2|Outcome|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
1056269|NCT00677898|O1|Outcome|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
1056270|NCT00677898|O2|Outcome|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
1056271|NCT00677898|O1|Outcome|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
1056474|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
1056272|NCT00677898|E2|Reported Event|Written Educational Materials|Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
1056273|NCT00677898|E1|Reported Event|Patient-centered Computerized Tool|A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
1056274|NCT00677833|B5|Baseline|Total|Total of all reporting groups
1056275|NCT00677833|B4|Baseline|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056276|NCT00677833|B3|Baseline|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056277|NCT00677833|B2|Baseline|Cohort 1: Artemether + Lumefantrine|"Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2.~Cohort 1 included participants between >=5 years of age and <=12 years of age."
1056278|NCT00677833|B1|Baseline|Cohort 1: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 1 included participants between >=5 years of age and <=12 years of age.
1056279|NCT00677833|P4|Participant Flow|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056280|NCT00677833|P3|Participant Flow|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056281|NCT00677833|P2|Participant Flow|Cohort 1: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 1 included participants between >=5 years of age and <=12 years of age.
1056282|NCT00677833|P1|Participant Flow|Cohort 1: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 1 included participants between greater than or equal to (>=) 5 years of age and less than or equal to (<=) 12 years of age.
1056283|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056284|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056285|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056286|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056287|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056288|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056289|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056290|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056475|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
1056291|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056292|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056293|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056294|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056295|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056296|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056297|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056298|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056299|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056300|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056301|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056302|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056303|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056304|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056305|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056306|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056307|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056308|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1063200|NCT00661492|O2|Outcome|Arm 2|Novantrone
1056309|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056310|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056311|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056312|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056313|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056314|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056315|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056316|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056317|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056318|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056319|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056320|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056321|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056322|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056323|NCT00677833|O2|Outcome|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056324|NCT00677833|O1|Outcome|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056325|NCT00677833|E4|Reported Event|Cohort 2: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056326|NCT00677833|E3|Reported Event|Cohort 2: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between >=6 months of age to <=59 months of age.
1056327|NCT00677833|E2|Reported Event|Cohort 1: Artemether + Lumefantrine|Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 1 included participants between >=5 years of age and <=12 years of age.
1056328|NCT00677833|E1|Reported Event|Cohort 1: Azithromycin + Chloroquine|Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams [mg] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base). Cohort 1 included participants between >=5 years of age and <=12 years of age.
1056329|NCT00677820|B3|Baseline|Total|Total of all reporting groups
1056330|NCT00677820|B2|Baseline|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
1056331|NCT00677820|B1|Baseline|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
1056332|NCT00677820|P2|Participant Flow|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
1056333|NCT00677820|P1|Participant Flow|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
1056334|NCT00677820|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
1056335|NCT00677820|O1|Outcome|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
1056336|NCT00677820|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
1056337|NCT00677820|O1|Outcome|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
1056338|NCT00677820|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
1056339|NCT00677820|O1|Outcome|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
1056340|NCT00677820|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
1056341|NCT00677820|O1|Outcome|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
1056342|NCT00677820|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
1056343|NCT00677820|O1|Outcome|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
1056344|NCT00677820|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
1056345|NCT00677820|O1|Outcome|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
1056346|NCT00677820|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
1056347|NCT00677820|O1|Outcome|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
1063201|NCT00661492|O1|Outcome|Arm 1|Novantrone+Erbitux
1056348|NCT00677820|E2|Reported Event|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0.
1056349|NCT00677820|E1|Reported Event|Trivalent Influenza Virus Vaccine|Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
1056350|NCT00677807|B4|Baseline|Total|Total of all reporting groups
1056351|NCT00677807|B3|Baseline|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1056352|NCT00677807|B2|Baseline|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1056353|NCT00677807|B1|Baseline|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1056354|NCT00677807|P3|Participant Flow|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1056355|NCT00677807|P2|Participant Flow|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1056356|NCT00677807|P1|Participant Flow|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1056357|NCT00677807|O3|Outcome|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1056358|NCT00677807|O2|Outcome|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1056359|NCT00677807|O1|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1056360|NCT00677807|O3|Outcome|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1056361|NCT00677807|O2|Outcome|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1056362|NCT00677807|O1|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1056363|NCT00677807|O3|Outcome|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1056364|NCT00677807|O2|Outcome|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1056365|NCT00677807|O1|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1056366|NCT00677807|O3|Outcome|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1056367|NCT00677807|O2|Outcome|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1056368|NCT00677807|O1|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1056369|NCT00677807|O3|Outcome|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1056370|NCT00677807|O2|Outcome|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1056371|NCT00677807|O1|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1056372|NCT00677807|O3|Outcome|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1056373|NCT00677807|O2|Outcome|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1056374|NCT00677807|O1|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1056375|NCT00677807|O3|Outcome|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1056376|NCT00677807|O2|Outcome|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1056377|NCT00677807|O1|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1056378|NCT00677807|O3|Outcome|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1056379|NCT00677807|O2|Outcome|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1056706|NCT00676520|E1|Reported Event|Subjects Receiving the XIENCE V EECSS|
1056380|NCT00677807|O1|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1056381|NCT00677807|E3|Reported Event|Placebo|Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1056382|NCT00677807|E2|Reported Event|Indacaterol 300 µg|Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1056383|NCT00677807|E1|Reported Event|Indacaterol 150 µg|Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1056384|NCT00677690|B3|Baseline|Total|Total of all reporting groups
1056385|NCT00677690|B2|Baseline|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
1056386|NCT00677690|B1|Baseline|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
1056387|NCT00677690|P2|Participant Flow|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
1056388|NCT00677690|P1|Participant Flow|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
1056389|NCT00677690|O2|Outcome|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
1056390|NCT00677690|O1|Outcome|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
1056391|NCT00677690|O2|Outcome|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
1056392|NCT00677690|O1|Outcome|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
1056393|NCT00677690|O2|Outcome|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
1056394|NCT00677690|O1|Outcome|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
1056395|NCT00677690|O2|Outcome|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
1056396|NCT00677690|O1|Outcome|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
1056397|NCT00677690|O2|Outcome|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
1056398|NCT00677690|O1|Outcome|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
1056399|NCT00677690|E2|Reported Event|Pulmonary Rehabilitation|Patients undergone to pulmonary rehabilitation
1056400|NCT00677690|E1|Reported Event|Neuromuscular Stimulation and Pulmonary Rehabilitation|Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation
1056401|NCT00677534|B1|Baseline|Cholecalciferol 50,000 U|Vitamin D
1056402|NCT00677534|P1|Participant Flow|Cholecalciferol 50,000 U|Vitamin D
1056403|NCT00677534|O1|Outcome|Cholecalciferol 50,000 U|Vitamin D
1056404|NCT00677534|E1|Reported Event|Cholecalciferol 50,000 U|Vitamin D
1056405|NCT00677365|B5|Baseline|Total|Total of all reporting groups
1056406|NCT00677365|B4|Baseline|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
1056407|NCT00677365|B3|Baseline|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
1056408|NCT00677365|B2|Baseline|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
1056409|NCT00677365|B1|Baseline|Placebo|Placebo Group
1056410|NCT00677365|P4|Participant Flow|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
1056411|NCT00677365|P3|Participant Flow|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
1056412|NCT00677365|P2|Participant Flow|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
1056413|NCT00677365|P1|Participant Flow|Placebo|Placebo Group
1056414|NCT00677365|O4|Outcome|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
1056415|NCT00677365|O3|Outcome|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
1056416|NCT00677365|O2|Outcome|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
1056417|NCT00677365|O1|Outcome|Placebo|Placebo Group
1056418|NCT00677365|O4|Outcome|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
1056419|NCT00677365|O3|Outcome|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
1056420|NCT00677365|O2|Outcome|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
1056421|NCT00677365|O1|Outcome|Placebo|Placebo Group
1056422|NCT00677365|O4|Outcome|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
1056423|NCT00677365|O3|Outcome|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
1056424|NCT00677365|O2|Outcome|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
1056425|NCT00677365|O1|Outcome|Placebo|Placebo Group
1056426|NCT00677365|O4|Outcome|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
1056427|NCT00677365|O3|Outcome|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
1056428|NCT00677365|O2|Outcome|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
1056429|NCT00677365|O1|Outcome|Placebo|Placebo Group
1056430|NCT00677365|O4|Outcome|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
1056431|NCT00677365|O3|Outcome|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
1056432|NCT00677365|O2|Outcome|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
1056433|NCT00677365|O1|Outcome|Placebo|Placebo Group
1056434|NCT00677365|O4|Outcome|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
1056435|NCT00677365|O3|Outcome|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
1056436|NCT00677365|O2|Outcome|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
1056437|NCT00677365|O1|Outcome|Placebo|Placebo Group
1056438|NCT00677365|E4|Reported Event|MP-376 240 mg BID|MP-376 240 mg Twice Daily (BID) Group
1056439|NCT00677365|E3|Reported Event|MP-376 240 mg QD|MP-376 240 mg Once Daily (QD) Group
1056440|NCT00677365|E2|Reported Event|MP-376 120 mg QD|MP-376 120 mg Once Daily (QD) Group
1056441|NCT00677365|E1|Reported Event|Placebo|Placebo Group
1056443|NCT00677352|B2|Baseline|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
1056444|NCT00677352|B1|Baseline|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
1056445|NCT00677352|P2|Participant Flow|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
1056446|NCT00677352|P1|Participant Flow|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
1056447|NCT00677352|O2|Outcome|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
1056448|NCT00677352|O1|Outcome|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
1056449|NCT00677352|O2|Outcome|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
1056450|NCT00677352|O1|Outcome|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
1056451|NCT00677352|O2|Outcome|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
1056452|NCT00677352|O1|Outcome|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
1056453|NCT00677352|O2|Outcome|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
1056476|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
1056477|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
1056478|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
1057069|NCT00675987|B3|Baseline|Total|Total of all reporting groups
1056454|NCT00677352|O1|Outcome|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
1056455|NCT00677352|O2|Outcome|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
1056456|NCT00677352|O1|Outcome|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
1056457|NCT00677352|O2|Outcome|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
1056458|NCT00677352|O1|Outcome|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
1056459|NCT00677352|O2|Outcome|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
1056460|NCT00677352|O1|Outcome|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
1056461|NCT00677352|E2|Reported Event|Paroxetine|"Treatment phase was started from 10 mg/day followed by increase to 20 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 30 mg/day.~At tapering phase, 20 mg/day was administered for 1 week after Week 12, followed by 10 mg/day for 1 week, and no study medication during the last 2 weeks."
1056462|NCT00677352|E1|Reported Event|Sertraline|"Treatment phase was started from 25 mg/day followed by increase to 50 mg/day at Week 1, and treatment was continued for 3 weeks. If there was no tolerability concern at Week 4 at the discretion of the investigator (or subinvestigator), the dose was increased to 75 mg/day and treatment was continued for 2 weeks. If there was no tolerability concern at Week 6 at the discretion of the investigator (or subinvestigator), the dose was increased to 100 mg/day.~At tapering phase, 50 mg/day was administered for 1 week after Week 12, followed by 25 mg/day for 1 week, and no study medication during the last 2 weeks."
1056463|NCT00677235|B3|Baseline|Total|Total of all reporting groups
1056464|NCT00677235|B2|Baseline|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
1056465|NCT00677235|B1|Baseline|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
1056466|NCT00677235|P2|Participant Flow|PTA Only|Percutaneous Transluminal Angioplasty (PTA): Treatment of stenoses with PTA only
1056467|NCT00677235|P1|Participant Flow|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
1056468|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
1056469|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
1056470|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
1056471|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
1056472|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
1056473|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
1056479|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
1056480|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
1056481|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
1056482|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
1056483|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
1056484|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
1056485|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
1056486|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
1056487|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
1056488|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
1056489|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
1056490|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
1056491|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
1056492|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
1056493|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
1056494|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
1056495|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
1056496|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
1056497|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
1056498|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
1056499|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
1056500|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
1056501|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
1056502|NCT00677235|O2|Outcome|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
1056503|NCT00677235|O1|Outcome|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
1056504|NCT00677235|E2|Reported Event|PTA Only|"Percutaneous Transluminal Angioplasty~PTA: Treatment of stenoses with PTA only"
1056505|NCT00677235|E1|Reported Event|FLAIR|"FLAIR Endovascular Stent Graft~FLAIR Endovascular Stent Graft: Treatment of stenoses with primary PTA and placement of the FLAIR Endovascular Stent Graft"
1056506|NCT00677092|B1|Baseline|Imatinib Mesylate Treatment|Imatinib mesylate 400 mg orally once daily for 4 months. Dosage was reduced to 200 mg if the participant developed gastrointestinal intolerance or alopecia.
1056507|NCT00677092|P1|Participant Flow|Imatinib Mesylate Treatment|Imatinib mesylate 400 mg orally once daily for 4 months. Dosage was reduced to 200 mg if participant developed gastrointestinal intolerance or alopecia.
1056508|NCT00677092|O1|Outcome|Imatinib Mesylate Treatment|Imatinib mesylate 400 mg orally once daily for 4 months. Dosage was reduced to 200 mg if the participant developed gastrointestinal intolerance or alopecia.
1056509|NCT00677092|O1|Outcome|Imatinib Mesylate Treatment|Imatinib mesylate 400 mg orally once daily for 4 months. Dosage was reduced to 200 mg if the participant developed gastrointestinal intolerance or alopecia.
1056510|NCT00677092|O1|Outcome|Imatinib Mesylate Treatment|Imatinib mesylate 400 mg orally once daily for 4 months. Dosage was reduced to 200 mg if the participant developed gastrointestinal intolerance or alopecia.
1056511|NCT00677092|O1|Outcome|Imatinib Mesylate Treatment|Imatinib mesylate 400 mg orally once daily for 4 months. Dosage was reduced to 200 mg if the participant developed gastrointestinal intolerance or alopecia.
1056512|NCT00677092|O1|Outcome|Imatinib Mesylate Treatment|Imatinib mesylate 400 mg orally once daily for 4 months. Dosage was reduced to 200 mg if the participant developed gastrointestinal intolerance or alopecia.
1056513|NCT00677092|O1|Outcome|Imatinib Mesylate Treatment|Imatinib mesylate 400 milligrams (mg) orally once daily for 4 months. Dosage was reduced to 200 mg if the participant developed gastrointestinal intolerance or alopecia.
1056514|NCT00677092|E1|Reported Event|Imatinib Mesylate Treatment|Imatinib mesylate 400 mg orally once daily for 4 months. Dosage was reduced to 200 mg if the participant developed gastrointestinal intolerance or alopecia.
1056515|NCT00677014|B4|Baseline|Total|Total of all reporting groups
1056516|NCT00677014|B3|Baseline|Algorithm Optimized AV Delay|Algorithm optimized AV delay with sensed and paced AV delay recommendations and LV offset set to 0
1056517|NCT00677014|B2|Baseline|Echo Optimized AV Delay|Echo optimized AV delay (Iterative Method), LV offset is optional
1056518|NCT00677014|B1|Baseline|Fixed AV Delay|Patients programmed to a Fixed nominal AV delay of 120 ms with a sensed AV offset set to 0 and the LV offset set to 0
1056686|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1056519|NCT00677014|P3|Participant Flow|Algorithm Optimized AV Delay|Algorithm optimized AV delay with sensed and paced AV delay recommendations and LV offset set to 0
1056520|NCT00677014|P2|Participant Flow|Echo Optimized AV Delay|Echo optimized AV delay (Iterative Method), LV offset is optional
1056521|NCT00677014|P1|Participant Flow|Fixed AV Delay|Patients programmed to a Fixed nominal AV delay of 120 ms with a sensed AV offset set to 0 and the LV offset set to 0
1056522|NCT00677014|O3|Outcome|Algorithm Optimized AV Delay|Algorithm optimized AV delay with sensed and paced AV delay recommendations and LV offset set to 0
1056523|NCT00677014|O2|Outcome|Echo Optimized AV Delay|Echo optimized AV delay (Iterative Method), LV offset is optional
1056524|NCT00677014|O1|Outcome|Fixed AV Delay|Patients programmed to a Fixed nominal AV delay of 120 ms with a sensed AV offset set to 0 and the LV offset set to 0
1056525|NCT00677014|E3|Reported Event|Algorithm Optimized AV Delay|Algorithm optimized AV delay with sensed and paced AV delay recommendations and LV offset set to 0
1056526|NCT00677014|E2|Reported Event|Echo Optimized AV Delay|Echo optimized AV delay (Iterative Method), LV offset is optional
1056527|NCT00677014|E1|Reported Event|Fixed AV Delay|Patients programmed to a Fixed nominal AV delay of 120 ms with a sensed AV offset set to 0 and the LV offset set to 0
1056528|NCT00676897|B3|Baseline|Total|Total of all reporting groups
1056529|NCT00676897|B2|Baseline|Placebo Group|Placebo: Corn Starch
1056530|NCT00676897|B1|Baseline|Statin Group|Simvastatin: Simvastatin 40mg PO or NGT
1056531|NCT00676897|P2|Participant Flow|Placebo Group|Placebo: Corn Starch
1056532|NCT00676897|P1|Participant Flow|Statin Group|Simvastatin: Simvastatin 40mg PO or NGT
1056533|NCT00676897|O2|Outcome|Placebo Group|Placebo: Corn Starch
1056534|NCT00676897|O1|Outcome|Statin Group|Simvastatin: Simvastatin 40mg PO or NGT
1056535|NCT00676897|O2|Outcome|Placebo Group|Placebo: Corn Starch
1056536|NCT00676897|O1|Outcome|Statin Group|Simvastatin: Simvastatin 40mg PO or NGT
1056537|NCT00676897|E2|Reported Event|Placebo Group|Placebo: Corn Starch
1056538|NCT00676897|E1|Reported Event|Statin Group|Simvastatin: Simvastatin 40mg PO or NGT
1056539|NCT00676806|B3|Baseline|Total|Total of all reporting groups
1056540|NCT00676806|B2|Baseline|Reduced Intensity Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning~Umbilical Cord Blood Transplantation After Reduced-Intensity Conditioning: Reduced Intensity Conditioning Regimen: Extracorporeal Photopheresis (days -8 & -7), cyclophosphamide 50 mg/kg (day -6) pentostatin 4 mg/kg/d (continuous infusion days -5 & -4), total body irradiation (days -3 & -2, total 600cGy) followed by Umbilical Cord Blood Infusion day 0."
1056541|NCT00676806|B1|Baseline|Myeloablative Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning~Umbilical Cord Blood Transplantation After Myeloablative Conditioning: Fully-myeloablative Conditioning Regimen: cyclophosphamide (60mg/m2 days -6 & -5), fludarabine (25 mg/m2 days -7, -6, & -5) and total body irradiation (days -3, -2, & -1, total 1200 cGy) followed by cord blood infusion on day 0."
1056542|NCT00676806|P2|Participant Flow|Reduced Intensity Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning~Umbilical Cord Blood Transplantation After Reduced-Intensity Conditioning: Reduced Intensity Conditioning Regimen: Extracorporeal Photopheresis (days -8 & -7), cyclophosphamide 50 mg/kg (day -6) pentostatin 4 mg/kg/d (continuous infusion days -5 & -4), total body irradiation (days -3 & -2, total 600cGy) followed by Umbilical Cord Blood Infusion day 0."
1056543|NCT00676806|P1|Participant Flow|Myeloablative Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning~Umbilical Cord Blood Transplantation After Myeloablative Conditioning: Fully-myeloablative Conditioning Regimen: cyclophosphamide (60mg/m2 days -6 & -5), fludarabine (25 mg/m2 days -7, -6, & -5) and total body irradiation (days -3, -2, & -1, total 1200 cGy) followed by cord blood infusion on day 0."
1056544|NCT00676806|O2|Outcome|Reduced Intensity Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning~1/2 evaluable subjects engrafted at +45 and +90 days. 3 evaluable subjects for toxicity."
1056545|NCT00676806|O1|Outcome|Myeloablative Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning.~2/2 evaluable subjects engrafted at +45 and +90 days. 3 evaluable subjects for toxicity."
1056546|NCT00676806|O2|Outcome|Reduced Intensity Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning
1056547|NCT00676806|O1|Outcome|Myeloablative Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning.
1056548|NCT00676806|O2|Outcome|Reduced Intensity Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning
1056549|NCT00676806|O1|Outcome|Myeloablative Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning.
1056550|NCT00676806|O2|Outcome|Reduced Intensity Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning
1056551|NCT00676806|O1|Outcome|Myeloablative Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning.
1056552|NCT00676806|O2|Outcome|Reduced Intensity Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning
1056553|NCT00676806|O1|Outcome|Myeloablative Conditioning|Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning.
1056554|NCT00676806|O2|Outcome|Reduced Intensity Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning~1/2 evaluable subjects engrafted at +45 and +90 days."
1056555|NCT00676806|O1|Outcome|Myeloablative Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning.~2/2 evaluable subjects engrafted at +45 and +90 days."
1056556|NCT00676806|E2|Reported Event|Reduced Intensity Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following non-myeloablative conditioning~Umbilical Cord Blood Transplantation After Reduced-Intensity Conditioning: Reduced Intensity Conditioning Regimen: Extracorporeal Photopheresis (days -8 & -7), cyclophosphamide 50 mg/kg (day -6) pentostatin 4 mg/kg/d (continuous infusion days -5 & -4), total body irradiation (days -3 & -2, total 600cGy) followed by Umbilical Cord Blood Infusion day 0."
1056557|NCT00676806|E1|Reported Event|Myeloablative Conditioning|"Patients receiving umbilical cord blood for hematopoietic rescue following myeloablative conditioning~Umbilical Cord Blood Transplantation After Myeloablative Conditioning: Fully-myeloablative Conditioning Regimen: cyclophosphamide (60mg/m2 days -6 & -5), fludarabine (25 mg/m2 days -7, -6, & -5) and total body irradiation (days -3, -2, & -1, total 1200 cGy) followed by cord blood infusion on day 0."
1056558|NCT00676793|B1|Baseline|ECGC and Breast Cancer|Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
1056559|NCT00676793|P1|Participant Flow|ECGC and Breast Cancer|Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
1056560|NCT00676793|O1|Outcome|ECGC and Breast Cancer|The effect of ECGC extract on biomarkers in breast cancer.
1056561|NCT00676793|O1|Outcome|ECGC and Breast Cancer|Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
1056562|NCT00676793|E1|Reported Event|ECGC and Breast Cancer|Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
1056563|NCT00676780|B1|Baseline|ECGC Extract, Prostate Cancer|Single arm for a phase II study of EGCG extract and prostate cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
1056564|NCT00676780|P1|Participant Flow|ECGC Extract, Prostate Cancer|Single arm for a phase II study of EGCG extract and prostate cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
1056565|NCT00676780|O1|Outcome|ECGC Extract|Epigallocatechin Gallate (ECGC) Single arm for a phase II study.
1056566|NCT00676780|O1|Outcome|ECGC Extract|Single arm for a phase II study of the effects of ECGC polyphenol extract from green tea on biomarkers in patients with prostate cancer.
1056567|NCT00676780|O1|Outcome|ECGC Extract|Single arm for a phase II study of the effects of Epigallocatechin Gallate (ECGC) polyphenol extract from green tea on biomarkers in patients with prostate cancer.
1056568|NCT00676780|E1|Reported Event|ECGC Extract, Prostate Cancer|Single arm for a phase II study of EGCG extract and prostate cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study.
1056569|NCT00676715|B5|Baseline|Total|Total of all reporting groups
1056570|NCT00676715|B4|Baseline|Avonex|Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
1056571|NCT00676715|B3|Baseline|Ocrelizumab 1000 mg|Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
1056572|NCT00676715|B2|Baseline|Ocrelizumab 600 mg|Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
1056573|NCT00676715|B1|Baseline|Placebo|Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
1056574|NCT00676715|P4|Participant Flow|Avonex|Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
1056575|NCT00676715|P3|Participant Flow|Ocrelizumab 1000 mg|Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
1056576|NCT00676715|P2|Participant Flow|Ocrelizumab 600 mg|Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
1056577|NCT00676715|P1|Participant Flow|Placebo|Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
1056578|NCT00676715|O4|Outcome|Avonex|Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
1056579|NCT00676715|O3|Outcome|Ocrelizumab 1000 mg|Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
1056687|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1056688|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1056580|NCT00676715|O2|Outcome|Ocrelizumab 600 mg|Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
1056581|NCT00676715|O1|Outcome|Placebo|Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
1056582|NCT00676715|O4|Outcome|Avonex|Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
1056583|NCT00676715|O3|Outcome|Ocrelizumab 1000 mg|Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
1056584|NCT00676715|O2|Outcome|Ocrelizumab 600 mg|Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
1056585|NCT00676715|O1|Outcome|Placebo|Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
1056586|NCT00676715|O4|Outcome|Avonex|Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
1056587|NCT00676715|O3|Outcome|Ocrelizumab 1000 mg|Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
1056588|NCT00676715|O2|Outcome|Ocrelizumab 600 mg|Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
1056589|NCT00676715|O1|Outcome|Placebo|Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
1056590|NCT00676715|O4|Outcome|Avonex|Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
1056591|NCT00676715|O3|Outcome|Ocrelizumab 1000 mg|Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
1056592|NCT00676715|O2|Outcome|Ocrelizumab 600 mg|Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
1056593|NCT00676715|O1|Outcome|Placebo|Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
1056594|NCT00676715|O4|Outcome|Avonex|Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
1056595|NCT00676715|O3|Outcome|Ocrelizumab 1000 mg|Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
1056596|NCT00676715|O2|Outcome|Ocrelizumab 600 mg|Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
1056597|NCT00676715|O1|Outcome|Placebo|Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
1056598|NCT00676715|O4|Outcome|Avonex|Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
1056599|NCT00676715|O3|Outcome|Ocrelizumab 1000 mg|Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
1056689|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1056690|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1056600|NCT00676715|O2|Outcome|Ocrelizumab 600 mg|Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
1056601|NCT00676715|O1|Outcome|Placebo|Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
1056602|NCT00676715|E4|Reported Event|Avonex|Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
1056603|NCT00676715|E3|Reported Event|Ocrelizumab 1000 mg|Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.
1056604|NCT00676715|E2|Reported Event|Ocrelizumab 600 mg|Participants received two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.
1056605|NCT00676715|E1|Reported Event|Placebo|Participants received two IV infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.
1056606|NCT00676689|B1|Baseline|SAPIEN THV|
1056607|NCT00676689|P1|Participant Flow|SAPIEN THV|
1056608|NCT00676689|O1|Outcome|SAPIEN THV|
1056609|NCT00676689|O1|Outcome|SAPIEN THV|
1056610|NCT00676689|O1|Outcome|SAPIEN THV|
1056611|NCT00676689|E1|Reported Event|SAPIEN THV|
1056612|NCT00676676|B1|Baseline|Testosterone|Testosterone Patch 300mcg replaced every 3-4 days
1056613|NCT00676676|P1|Participant Flow|Testosterone|Testosterone Patch 300mcg replaced every 3-4 days
1056614|NCT00676676|O1|Outcome|Testosterone|Testosterone Patch 300mcg replaced every 3-4 days
1056615|NCT00676676|E1|Reported Event|Testosterone|Testosterone Patch 300mcg replaced every 3-4 days
1056616|NCT00676650|B3|Baseline|Total|Total of all reporting groups
1056617|NCT00676650|B2|Baseline|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
1056618|NCT00676650|B1|Baseline|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
1056619|NCT00676650|P2|Participant Flow|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
1056620|NCT00676650|P1|Participant Flow|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
1056621|NCT00676650|O2|Outcome|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
1056622|NCT00676650|O1|Outcome|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
1056623|NCT00676650|O2|Outcome|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
1056624|NCT00676650|O1|Outcome|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
1056625|NCT00676650|O2|Outcome|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
1056626|NCT00676650|O1|Outcome|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
1056627|NCT00676650|O2|Outcome|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
1056691|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1056692|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1056693|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1056628|NCT00676650|O1|Outcome|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
1056629|NCT00676650|O2|Outcome|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
1056630|NCT00676650|O1|Outcome|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
1056631|NCT00676650|O2|Outcome|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
1056632|NCT00676650|O1|Outcome|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
1056633|NCT00676650|O2|Outcome|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
1056634|NCT00676650|O1|Outcome|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
1056635|NCT00676650|E2|Reported Event|Placebo and Prednisone|Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
1056636|NCT00676650|E1|Reported Event|Sunitinib and Prednisone|Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution.
1056637|NCT00676585|B3|Baseline|Total|Total of all reporting groups
1056638|NCT00676585|B2|Baseline|Intervention|Hydrocortisone
1056639|NCT00676585|B1|Baseline|Control|Normal Saline
1056640|NCT00676585|P2|Participant Flow|Intervention|Hydrocortisone
1056641|NCT00676585|P1|Participant Flow|Control|Normal Saline
1056642|NCT00676585|O2|Outcome|Intervention|Hydrocortisone
1056643|NCT00676585|O1|Outcome|Control|Normal Saline
1056644|NCT00676585|O2|Outcome|Intervention|Hydrocortisone
1056645|NCT00676585|O1|Outcome|Control|Normal Saline
1056646|NCT00676585|O2|Outcome|Intervention|Hydrocortisone
1056647|NCT00676585|O1|Outcome|Control|Normal Saline
1056648|NCT00676585|E2|Reported Event|Intervention|Hydrocortisone
1056649|NCT00676585|E1|Reported Event|Control|Normal Saline
1056650|NCT00676520|B1|Baseline|Subjects Receiving the XIENCE V EECSS|
1056651|NCT00676520|P1|Participant Flow|Subjects Receiving the XIENCE V EECSS|
1056652|NCT00676520|O5|Outcome|Perception of Disease/Quality of Life|
1056653|NCT00676520|O4|Outcome|Treatment Satisfaction|
1056654|NCT00676520|O3|Outcome|Angina Frequency|
1056655|NCT00676520|O2|Outcome|Angina Stability|
1056656|NCT00676520|O1|Outcome|Physical Limitations|
1056657|NCT00676520|O5|Outcome|Perception of Disease/Quality of Life|
1056658|NCT00676520|O4|Outcome|Treatment Satisfaction|
1056659|NCT00676520|O3|Outcome|Angina Frequency|
1056660|NCT00676520|O2|Outcome|Angina Stability|
1056661|NCT00676520|O1|Outcome|Physical Limitations|
1056662|NCT00676520|O5|Outcome|Perception of Disease/Quality of Life|
1056663|NCT00676520|O4|Outcome|Treatment Satisfaction|
1056664|NCT00676520|O3|Outcome|Angina Frequency|
1056665|NCT00676520|O2|Outcome|Angina Stability|
1056666|NCT00676520|O1|Outcome|Physical Limitations|
1056667|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1056668|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1056669|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1056670|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1056671|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1056672|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1056673|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1056674|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1056675|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1056676|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1056677|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1056678|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1056679|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1056680|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1056681|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1056682|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1056683|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1056684|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1056685|NCT00676520|O1|Outcome|Subjects Receiving the XIENCE V EECSS|
1056707|NCT00676494|B1|Baseline|All Patients|Patients meeting eligibility criteria and enrolled in the study.
1056708|NCT00676494|P1|Participant Flow|All Patients|Patients meeting eligibility criteria and enrolled in the study.
1056709|NCT00676494|O1|Outcome|All Patients|Patients meeting eligibility criteria and enrolled in the study.
1056710|NCT00676494|O1|Outcome|All Patients|Patients meeting eligibility criteria and enrolled in the study.
1056711|NCT00676494|O1|Outcome|All Patients|Patients meeting eligibility criteria and enrolled in the study.
1056712|NCT00676494|O1|Outcome|All Patients|Patients meeting eligibility criteria and enrolled in the study.
1056713|NCT00676455|B1|Baseline|Metastatic Lung and Liver Tumor Growth Measurement|This arm of the study will collect information (size and volume changes)of metastatic Lung and Liver tumors
1056714|NCT00676455|P1|Participant Flow|Metastatic Lung and Liver Tumor Growth Measurement|This arm of the study will collect information (size and volume changes)of metastatic Lung and Liver tumors
1056715|NCT00676455|O1|Outcome|Metastatic Lung and Liver Tumor Growth Measurement|This arm of the study will collect information (size and volume changes)of metastatic Lung and Liver tumors
1056716|NCT00676455|O1|Outcome|Metastatic Lung and Liver Tumor Growth Measurement|This arm of the study will collect information (size and volume changes)of metastatic Lung and Liver tumors
1056717|NCT00676455|E1|Reported Event|Metastatic Lung and Liver Tumor Growth Measurement|This arm of the study will collect information (size and volume changes)of metastatic Lung and Liver tumors
1056718|NCT00676403|B7|Baseline|Total|Total of all reporting groups
1056719|NCT00676403|B6|Baseline|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
1056720|NCT00676403|B5|Baseline|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
1056721|NCT00676403|B4|Baseline|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
1056722|NCT00676403|B3|Baseline|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
1056723|NCT00676403|B2|Baseline|Pregabalin 50 mg|Single daily 50 mg oral dose.
1056724|NCT00676403|B1|Baseline|Placebo|Single daily oral dose.
1056725|NCT00676403|P6|Participant Flow|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
1056726|NCT00676403|P5|Participant Flow|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
1056727|NCT00676403|P4|Participant Flow|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
1056728|NCT00676403|P3|Participant Flow|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
1056729|NCT00676403|P2|Participant Flow|Pregabalin 50 mg|Single daily 50 mg oral dose.
1056730|NCT00676403|P1|Participant Flow|Placebo|Single daily oral dose.
1056731|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
1056732|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
1056733|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
1056734|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
1056735|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
1056736|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
1056737|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
1056738|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
1056739|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
1056740|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
1056741|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
1056742|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
1056743|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
1056744|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
1056745|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
1056746|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
1056747|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
1056748|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
1056749|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
1056750|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
1056751|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
1056752|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
1056753|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
1056754|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
1056755|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
1056756|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
1056757|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
1056758|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
1056759|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
1056760|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
1056761|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
1056762|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
1056763|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
1056764|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
1056765|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
1056766|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
1056767|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
1056768|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
1056769|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
1056770|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
1056771|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
1056772|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
1056773|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
1056774|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
1056775|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
1056776|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
1056777|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
1056778|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
1056779|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
1056780|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
1056781|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
1056782|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
1056783|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
1056784|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
1056785|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
1056786|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
1056787|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
1056788|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
1056789|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
1056790|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
1056791|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
1056792|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
1056793|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
1056794|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
1056795|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
1056796|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
1056797|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
1056798|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
1056799|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
1056800|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
1056801|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
1056802|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
1056803|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
1056804|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
1056805|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
1056806|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
1056807|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
1056808|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
1056809|NCT00676403|O6|Outcome|Pregablin 450 mg/Day|
1056810|NCT00676403|O5|Outcome|Pregabalin 300 mg/Day|
1056811|NCT00676403|O4|Outcome|Pregabalin 150 mg/Day|
1056812|NCT00676403|O3|Outcome|Pregabalin 100 mg/Day|
1056813|NCT00676403|O2|Outcome|Pregabalin 50 mg/Day|
1056814|NCT00676403|O1|Outcome|Placebo|
1056815|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
1056816|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
1056817|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
1056818|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
1056819|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
1056820|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
1056821|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
1056822|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
1056823|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
1056824|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
1056825|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
1056826|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
1056827|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
1056828|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
1056829|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
1056830|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
1056831|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
1056832|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
1056833|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
1056834|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
1056835|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
1056836|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
1056837|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
1056838|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
1056839|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
1056840|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
1056841|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
1056842|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
1056843|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
1056844|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
1056845|NCT00676403|O6|Outcome|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
1056846|NCT00676403|O5|Outcome|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
1056847|NCT00676403|O4|Outcome|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
1056848|NCT00676403|O3|Outcome|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
1056849|NCT00676403|O2|Outcome|Pregabalin 50 mg|Single daily 50 mg oral dose.
1056850|NCT00676403|O1|Outcome|Placebo|Single daily oral dose.
1056851|NCT00676403|E6|Reported Event|Pregabalin 450 mg|Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
1056852|NCT00676403|E5|Reported Event|Pregabalin 300 mg|Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
1056853|NCT00676403|E4|Reported Event|Pregabalin 150 mg|Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
1056854|NCT00676403|E3|Reported Event|Pregabalin 100 mg|Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
1056855|NCT00676403|E2|Reported Event|Pregabalin 50 mg|Single daily 50 mg oral dose.
1056856|NCT00676403|E1|Reported Event|Placebo|Single daily oral dose.
1056857|NCT00676364|B3|Baseline|Total|Total of all reporting groups
1056858|NCT00676364|B2|Baseline|Investigational Group|Investigational group receiving blinded 4% lidocaine cream
1056859|NCT00676364|B1|Baseline|ControI Group Receiving Placebo Cream Before Venipuncture|Experimential group receiving medicated topical cream prior to venipuncture
1056860|NCT00676364|P2|Participant Flow|Investigational Group Receiving 4% Lidocaine|Investigational group receiving blinded 4% lidocaine cream under occlusive dressing for 15 mins prior to venipuncture
1056861|NCT00676364|P1|Participant Flow|ControI Group Receiving Placebo Cream|Control group receiving blinded placebo cream under occlusive dressing prior to venipuncture
1056862|NCT00676364|O2|Outcome|Investigational Group Receiving 4% Lidocaine Cream|The investigational group received blinded 4% lidocaine cream under occlusive dressing for 15 minutes prior to venipuncture.
1056863|NCT00676364|O1|Outcome|ControI Group Receiving Placebo Cream|The control group received blinded placebo cream under occlusive dressing for 15 minutes prior to venipuncture.
1056864|NCT00676364|O2|Outcome|Investigational Group|Investigational group receiving 4% lidocaine cream prior to venipuncture
1056865|NCT00676364|O1|Outcome|ControI Group Receiving Placebo Cream|Control group receiving placebo topical cream prior to venipuncture
1056866|NCT00676364|E2|Reported Event|Investigational Group|Investigational group receiving 4% lidocaine cream prior to venipuncture
1056867|NCT00676364|E1|Reported Event|ControI Group Receiving Placebo Cream|Control group receiving placebo topical cream prior to venipuncture
1056868|NCT00676338|B5|Baseline|Total|Total of all reporting groups
1056869|NCT00676338|B4|Baseline|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
1056870|NCT00676338|B3|Baseline|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
1056871|NCT00676338|B2|Baseline|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
1056872|NCT00676338|B1|Baseline|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
1056873|NCT00676338|P4|Participant Flow|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
1056874|NCT00676338|P3|Participant Flow|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
1056875|NCT00676338|P2|Participant Flow|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
1056876|NCT00676338|P1|Participant Flow|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
1056877|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
1056878|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
1056879|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
1056880|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
1056881|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
1056882|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
1056883|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
1056884|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
1056885|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
1056886|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
1056887|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
1056888|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
1056889|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
1056890|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
1056891|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
1056892|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
1056893|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
1056894|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
1056895|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
1056896|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
1056897|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
1056898|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
1056899|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
1056900|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
1056901|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
1056902|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
1056903|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
1056904|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
1056905|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
1056906|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
1056907|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
1056908|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
1056909|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
1056910|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
1056911|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
1057070|NCT00675987|B2|Baseline|Placebo 1 Tab po QD|Placebo 1 tab po QD
1056912|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
1056913|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
1056914|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
1056915|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
1056916|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
1056917|NCT00676338|O4|Outcome|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
1056918|NCT00676338|O3|Outcome|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
1056919|NCT00676338|O2|Outcome|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
1056920|NCT00676338|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
1056921|NCT00676338|E4|Reported Event|Sitagliptin|Sitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection
1056922|NCT00676338|E3|Reported Event|Pioglitazone|Pioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection
1056923|NCT00676338|E2|Reported Event|Metformin|Metformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection
1056924|NCT00676338|E1|Reported Event|Exenatide Once Weekly|Exenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo
1056925|NCT00676208|B3|Baseline|Total|Total of all reporting groups
1056926|NCT00676208|B2|Baseline|Comparison|Medical students who do not experience Shared Medical Appointments.
1056927|NCT00676208|B1|Baseline|SMA Participants|Medical Students who were assigned to observe Shared Medical Appointments (SMA).
1056928|NCT00676208|P2|Participant Flow|Comparison|Medical students who do not experience Shared Medical Appointments during the study period April to August 2008.
1056929|NCT00676208|P1|Participant Flow|Intervention|Medical Students who are assigned to observe Shared Medical Appointments.
1056930|NCT00676208|O2|Outcome|Comparison|Medical students who do not experience Shared Medical Appointments (SMA).
1056931|NCT00676208|O1|Outcome|SMA Particiants|Medical students who were assigned to observe Shared Medical Appointments (SMA).
1056932|NCT00676208|O2|Outcome|Comparison|Medical Students who do not experience Shared Medical Appointments.
1056933|NCT00676208|O1|Outcome|SMA Participants|Medical students who are assigned to observe Shared Medical Appointments (SMA).
1056934|NCT00676208|E2|Reported Event|Comparison|Medical students who do not experience Shared Medical Appointments.
1056935|NCT00676208|E1|Reported Event|SMA Participants|Medical students who were assigned to observe Shared Medical Appointments (SMA).
1056936|NCT00676195|B1|Baseline|N-Acetyl Cysteine|"N-Acetyl Cysteine: Dosage of orally administered N-Acetyl Cysteine is as follows:~Days 1-30: 900 mg, once per day Days 31-60: 900 mg, twice per day Days 61-90: 900 mg, three times per day"
1056937|NCT00676195|P1|Participant Flow|N-Acetyl Cysteine|"N-Acetyl Cysteine: Dosage of orally administered N-Acetyl Cysteine is as follows:~Days 1-30: 900 mg, once per day Days 31-60: 900 mg, twice per day Days 61-90: 900 mg, three times per day"
1056938|NCT00676195|O1|Outcome|Open-Label|
1056939|NCT00676195|O1|Outcome|Open-Label|
1056940|NCT00676195|O1|Outcome|Open-Label|
1056941|NCT00676195|O1|Outcome|Open-Label|
1056942|NCT00676195|O1|Outcome|N-Acetyl Cysteine|"N-Acetyl Cysteine: Dosage of orally administered N-Acetyl Cysteine is as follows:~Days 1-30: 900 mg, once per day Days 31-60: 900 mg, twice per day Days 61-90: 900 mg, three times per day"
1056943|NCT00676195|E1|Reported Event|N-Acetyl Cysteine|"N-Acetyl Cysteine: Dosage of orally administered N-Acetyl Cysteine is as follows:~Days 1-30: 900 mg, once per day Days 31-60: 900 mg, twice per day Days 61-90: 900 mg, three times per day"
1056944|NCT00676182|B3|Baseline|Total|Total of all reporting groups
1056945|NCT00676182|B2|Baseline|Telerehabilitation TBI/PTSD|"Telerehabilitation TBI/PTSD~Telerehabilitation: Rehabilitation via computer assisted internet capabilities for veterans with TBI and comorbid PTSD"
1056946|NCT00676182|B1|Baseline|Telerehabilitation TBI|"Telerehabilitation TBI~Telerehabilitation: Rehabilitation via computer assisted internet capabilities for veterans with TBI"
1056947|NCT00676182|P1|Participant Flow|Telerehabilitation|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities"
1056948|NCT00676182|O1|Outcome|Telerehabilitation TBI/PTSD|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities for veterans with TBI/PTSD"
1056949|NCT00676182|O1|Outcome|Telerehabilitation TBI/PTSD|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities for veterans with TBI/PTSD"
1056950|NCT00676182|O1|Outcome|Telerehabilitation TBI/PTSD|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities for veterans with TBI/PTSD"
1056951|NCT00676182|O1|Outcome|Telerehabilitation TBI/PTSD|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities for veterans with TBI/PTSD"
1056952|NCT00676182|O1|Outcome|Telerehabilitation TBI/PTSD|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities for TBI/PTSD"
1056953|NCT00676182|O1|Outcome|Telerehabilitation|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities"
1056954|NCT00676182|O3|Outcome|Telerehabilitation 12 Months|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities"
1056955|NCT00676182|O2|Outcome|Telerehabilitation 6 Months|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities"
1056956|NCT00676182|O1|Outcome|Telerehabilitation Baseline|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities"
1056957|NCT00676182|O1|Outcome|Telerehabilitation|"Telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities for all subjects"
1063202|NCT00661492|E2|Reported Event|Arm 2|Novantrone
1056958|NCT00676182|E1|Reported Event|Telerehabilitation|"telerehabilitation~Telerehabilitation: Rehabilitation via computer assisted internet capabilities"
1056959|NCT00676143|B3|Baseline|Total|Total of all reporting groups
1056960|NCT00676143|B2|Baseline|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056961|NCT00676143|B1|Baseline|Placebo|Participants received placebo by intravenous (IV) infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks.
1056962|NCT00676143|P2|Participant Flow|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056963|NCT00676143|P1|Participant Flow|Placebo|Participants received placebo by intravenous (IV) infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks.
1056964|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056965|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056966|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056967|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056968|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056969|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056970|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056971|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056972|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056973|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056974|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056975|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056976|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056977|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056978|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056979|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056980|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056981|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056982|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056983|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056984|NCT00676143|O2|Outcome|Bapineuzumab 0.5 mg/kg|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056985|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056986|NCT00676143|O2|Outcome|Bapineuzumab 0.5 mg/kg|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056987|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056988|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056989|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056990|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056991|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056992|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056993|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056994|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056995|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1057071|NCT00675987|B1|Baseline|Losartan 100 mg 1 Tab po QD|Losartan 100 mg 1 tab po QD
1056996|NCT00676143|O2|Outcome|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056997|NCT00676143|O1|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056998|NCT00676143|E2|Reported Event|Bapineuzumab|Participants received bapineuzumab 0.5 mg/kg by IV infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks
1056999|NCT00676143|E1|Reported Event|Placebo|Participants received placebo by intravenous (IV) infusion every 13 weeks up to 6 doses (65 weeks). Participants were followed up until 78 weeks.
1057000|NCT00676130|B3|Baseline|Total|Total of all reporting groups
1057001|NCT00676130|B2|Baseline|Placebo|Cephalexin plus placebo
1057002|NCT00676130|B1|Baseline|Trimethoprim-sulfamethoxazole|Cephalexin plus trimethoprim-sulfamethoxazole
1057003|NCT00676130|P2|Participant Flow|Placebo|Cephalexin plus placebo
1057004|NCT00676130|P1|Participant Flow|Trimethoprim-sulfamethoxazole|Cephalexin plus trimethoprim-sulfamethoxazole
1057005|NCT00676130|O2|Outcome|Placebo|Cephalexin plus placebo
1057006|NCT00676130|O1|Outcome|Trimethoprim-sulfamethoxazole|Cephalexin plus trimethoprim-sulfamethoxazole
1057007|NCT00676130|O2|Outcome|Placebo|Cephalexin plus placebo
1057008|NCT00676130|O1|Outcome|Trimethoprim-sulfamethoxazole|Cephalexin plus trimethoprim-sulfamethoxazole
1057009|NCT00676130|E2|Reported Event|Placebo|Cephalexin plus placebo
1057010|NCT00676130|E1|Reported Event|Trimethoprim-sulfamethoxazole|Cephalexin plus trimethoprim-sulfamethoxazole
1057011|NCT00676091|B3|Baseline|Total|Total of all reporting groups
1057012|NCT00676091|B2|Baseline|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1057013|NCT00676091|B1|Baseline|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1057014|NCT00676091|P2|Participant Flow|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1057015|NCT00676091|P1|Participant Flow|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1057016|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1057017|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1057018|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1057019|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1057020|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1057021|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1057022|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1057023|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1057024|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1057025|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1057026|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1057027|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1057028|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1057029|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1057030|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1057031|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1057032|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1057033|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1057034|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1057035|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1057036|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1057037|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1057038|NCT00676091|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1057039|NCT00676091|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1057040|NCT00676091|E6|Reported Event|Toddler Dose 7vPnC|"7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 12 months of age (toddler dose).~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (non-solicited) Other Adverse Events N=64; systematic (solicited) Local Reactions N=67; systematic (solicited) Systemic Events N=86."
1057041|NCT00676091|E5|Reported Event|Toddler Dose 13vPnC|"13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 12 months of age (toddler dose).~7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 12 months of age (toddler dose).~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (non-solicited) Other Adverse Events N=69; systematic (solicited) Local Reactions N=81; systematic (solicited) Systemic Events N=84. Total N at Risk=155: 1 participant had no record of safety information during the Toddler dose period and was not included in the Safety population."
1057042|NCT00676091|E4|Reported Event|After the Infant Series 7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age).
1057043|NCT00676091|E3|Reported Event|After the Infant Series 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age).
1057044|NCT00676091|E2|Reported Event|Infant Series 7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series).
1057045|NCT00676091|E1|Reported Event|Infant Series 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series).
1057046|NCT00676065|B4|Baseline|Total|Total of all reporting groups
1057047|NCT00676065|B3|Baseline|OC-other|Users of oral contraceptives containing other progestogens
1057048|NCT00676065|B2|Baseline|OC-LNG|Users of oral contraceptives containing levonorgestrel
1057049|NCT00676065|B1|Baseline|DRSP/EE|Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol
1057050|NCT00676065|P3|Participant Flow|OC-other|Users of oral contraceptives containing other progestogens
1057051|NCT00676065|P2|Participant Flow|OC-LNG|Users of oral contraceptives containing levonorgestrel
1057052|NCT00676065|P1|Participant Flow|Yasmin|Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol
1057053|NCT00676065|O3|Outcome|OC-other|Users of oral contraceptives containing other progestogens
1057054|NCT00676065|O2|Outcome|OC-LNG|Users of oral contraceptives containing levonorgestrel
1057055|NCT00676065|O1|Outcome|DRSP/EE|Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol
1057056|NCT00676065|O3|Outcome|OC-other|Users of oral contraceptives containing other progestogens
1057057|NCT00676065|O2|Outcome|OC-LNG|Users of oral contraceptives containing levonorgestrel
1057058|NCT00676065|O1|Outcome|DRSP/EE|Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol
1057059|NCT00676065|O3|Outcome|OC-other|Users of oral contraceptives containing other progestogens
1057060|NCT00676065|O2|Outcome|OC-LNG|Users of oral contraceptives containing levonorgestrel
1057061|NCT00676065|O1|Outcome|DRSP/EE|Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol
1057062|NCT00676065|E3|Reported Event|OC-other|Users of oral contraceptives containing other progestogens
1057063|NCT00676065|E2|Reported Event|OC-LNG|Users of oral contraceptives containing levonorgestrel
1057064|NCT00676065|E1|Reported Event|DRSP/EE|Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol
1057065|NCT00676026|B1|Baseline|All Participants|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
1057066|NCT00676026|P1|Participant Flow|All Participants|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 8, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
1057067|NCT00676026|O1|Outcome|All Participants|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
1057068|NCT00676026|E1|Reported Event|All Participants|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 8, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
1057073|NCT00675987|P1|Participant Flow|Losartan 100 mg 1 Tab po QD|Losartan 100 mg 1 tab po QD
1057074|NCT00675987|O2|Outcome|Losartan|
1057075|NCT00675987|O1|Outcome|Placebo|
1057076|NCT00675987|O2|Outcome|Losartan|
1057077|NCT00675987|O1|Outcome|Placebo|
1057078|NCT00675987|E2|Reported Event|Placebo 1 Tab po QD|Placebo 1 tab po QD
1057079|NCT00675987|E1|Reported Event|Losartan 100 mg 1 Tab po QD|Losartan 100 mg 1 tab po QD
1057080|NCT00675948|B3|Baseline|Total|Total of all reporting groups
1057081|NCT00675948|B2|Baseline|THC Alone|Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC
1057082|NCT00675948|B1|Baseline|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD
1057083|NCT00675948|P2|Participant Flow|THC Alone|Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC
1057084|NCT00675948|P1|Participant Flow|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD
1057085|NCT00675948|O2|Outcome|THC Alone|Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC
1057086|NCT00675948|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD
1057087|NCT00675948|O2|Outcome|THC Alone|Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC
1057088|NCT00675948|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD
1057089|NCT00675948|O2|Outcome|THC Alone|Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC
1057090|NCT00675948|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD)
1057091|NCT00675948|E2|Reported Event|THC Alone|Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC
1057092|NCT00675948|E1|Reported Event|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD
1057093|NCT00675922|B1|Baseline|Sulfamylon vs Silver Nitrate Solution|Application of Sulfamylon 5% and Silver Nitrate Solution soaked dressings to a burned area
1057094|NCT00675922|P1|Participant Flow|Sulfamylon Solution 5% and Silver Nitrate Soaks|Application of Sulfamylon 5% and Silver Nitrate Solution soaked dressings to a burned area
1057095|NCT00675922|O2|Outcome|Percent Infections: Silver Nitrate Site|Percent of sites that developed infections with Silver Nitrate soaks
1057096|NCT00675922|O1|Outcome|Percent Infections:Sulfamylon Site|Percent of sites that developed infections with Sulfamylon soaks
1057097|NCT00675922|E1|Reported Event|Sulfamylon Soaks, Silver Nitrate Soaks|Patients receive both treatments and each treated site is compared.
1057098|NCT00675909|B4|Baseline|Total|Total of all reporting groups
1057099|NCT00675909|B3|Baseline|Intranasal Midazolam|"Participants in the group are given intranasal midazolam as sedation related to laceration repair procedures in the emergency department.~Midazolam will be administered via aerosolization (using atomizer) with half of dose in each nostril. Total dose is 0.3mg/kg."
1057100|NCT00675909|B2|Baseline|Buccal Midazolam|"Participants in the group are given buccal midazolam as sedation related to laceration repair procedures in the emergency department.~0.3mg/kg total dose administered with aerosolization device (atomizer) sprayed onto buccal mucosa inside the cheek on both sides of mouth."
1057101|NCT00675909|B1|Baseline|Oral Midazolam|"Participants in the group are given oral midazolam as sedation related to laceration repair procedures in the emergency department.~0.5mg/kg of midazolam taken orally."
1057102|NCT00675909|P3|Participant Flow|Intranasal Midazolam|"Participants in the group are given intranasal midazolam as sedation related to laceration repair procedures in the emergency department.~Midazolam will be administered via aerosolization (using atomizer) with half of dose in each nostril. Total dose is 0.3mg/kg."
1057103|NCT00675909|P2|Participant Flow|Buccal Midazolam|"Participants in the group are given buccal midazolam as sedation related to laceration repair procedures in the emergency department.~0.3mg/kg total dose administered with aerosolization device (atomizer) sprayed onto buccal mucosa inside the cheek on both sides of mouth."
1057104|NCT00675909|P1|Participant Flow|Oral Midazolam|"Participants in the group are given oral midazolam as sedation related to laceration repair procedures in the emergency department.~0.5mg/kg of midazolam taken orally."
1057105|NCT00675909|O3|Outcome|Buccal Midazolam|"Participants in the group are given buccal midazolam as sedation related to laceration repair procedures in the emergency department.~0.3mg/kg total dose administered with aerosolization device (atomizer) sprayed onto buccal mucosa inside the cheek on both sides of mouth."
1057106|NCT00675909|O2|Outcome|Intranasal Midazolam|"Participants in the group are given intranasal midazolam as sedation related to laceration repair procedures in the emergency department.~Midazolam will be administered via aerosolization (using atomizer) with half of dose in each nostril. Total dose is 0.3mg/kg."
1057107|NCT00675909|O1|Outcome|Oral Midazolam|"Participants in the group are given oral midazolam as sedation related to laceration repair procedures in the emergency department.~0.5mg/kg of midazolam taken orally."
1057108|NCT00675909|E3|Reported Event|Intranasal Midazolam|"Participants in the group are given intranasal midazolam as sedation related to laceration repair procedures in the emergency department.~Midazolam will be administered via aerosolization (using atomizer) with half of dose in each nostril. Total dose is 0.3mg/kg."
1057109|NCT00675909|E2|Reported Event|Buccal Midazolam|"Participants in the group are given buccal midazolam as sedation related to laceration repair procedures in the emergency department.~0.3mg/kg total dose administered with aerosolization device (atomizer) sprayed onto buccal mucosa inside the cheek on both sides of mouth."
1057110|NCT00675909|E1|Reported Event|Oral Midazolam|"Participants in the group are given oral midazolam as sedation related to laceration repair procedures in the emergency department.~0.5mg/kg of midazolam taken orally."
1057111|NCT00675792|B3|Baseline|Total|Total of all reporting groups
1057112|NCT00675792|B2|Baseline|Neostigmine|50 µg/kg neostigmine
1057113|NCT00675792|B1|Baseline|Sugammadex|4 mg/kg sugammadex
1057114|NCT00675792|P2|Participant Flow|Neostigmine|50 µg/kg neostigmine
1057115|NCT00675792|P1|Participant Flow|Sugammadex|4 mg/kg sugammadex
1057116|NCT00675792|O2|Outcome|Neostigmine|50 µg/kg neostigmine
1057131|NCT00675766|B4|Baseline|Group 4|HIV-negative controls 18-40 years old
1057135|NCT00675766|P4|Participant Flow|Group 4|HIV-negative controls 18-40 years old
1057136|NCT00675766|P3|Participant Flow|Group 3|HIV-negative controls 50 and older
1057137|NCT00675766|P2|Participant Flow|Group 2|HIV-positive adults 18-40 years old
1057138|NCT00675766|P1|Participant Flow|Group 1|HIV-positive adults 50 and older
1057139|NCT00675766|O4|Outcome|Group 4|HIV-negative controls 18-40 years old
1057140|NCT00675766|O3|Outcome|Group 3|HIV-negative controls 50 and older
1057141|NCT00675766|O2|Outcome|Group 2|HIV-positive adults 18-40 years old
1057142|NCT00675766|O1|Outcome|Group 1|HIV-positive adults 50 and older
1057143|NCT00675766|E4|Reported Event|Group 4|HIV-negative controls 18-40 years old
1057144|NCT00675766|E3|Reported Event|Group 3|HIV-negative controls 50 and older
1057145|NCT00675766|E2|Reported Event|Group 2|HIV-positive adults 18-40 years old
1057146|NCT00675766|E1|Reported Event|Group 1|HIV-positive adults 50 and older
1057147|NCT00675597|B1|Baseline|Docetaxel (Taxotere®) Plus Vinorelbine|Docetaxel (Taxotere®) plus Vinorelbine as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer
1057148|NCT00675597|P1|Participant Flow|Docetaxel (Taxotere®) Plus Vinorelbine|Docetaxel (Taxotere®) plus Vinorelbine as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer
1057149|NCT00675597|O1|Outcome|Docetaxel (Taxotere®) Plus Vinorelbine|Docetaxel (Taxotere®) plus Vinorelbine as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer
1057150|NCT00675597|E1|Reported Event|Docetaxel (Taxotere®) Plus Vinorelbine|Docetaxel (Taxotere®) plus Vinorelbine as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer
1057151|NCT00675584|B3|Baseline|Total|Total of all reporting groups
1057152|NCT00675584|B2|Baseline|Intermittent Budesonide|Participants will receive 1 mg of ICS (budesonide as Pulmicort Respules®) twice a day for 7 days at the onset of a respiratory tract illness; they will receive placebo ICS once a day at all other times during the study.
1057153|NCT00675584|B1|Baseline|Daily Budesonide|Participants will receive 0.5 mg of ICS (budesonide as Pulmicort Respules®) once a day at night, except during respiratory tract illnesses. During respiratory tract illnesses, participants will receive placebo each morning and 0.5 mg of budesonide each night for 7 days.
1057154|NCT00675584|P2|Participant Flow|Intermittent Budesonide|Participants will receive 1 mg of ICS (budesonide as Pulmicort Respules®) twice a day for 7 days at the onset of a respiratory tract illness; they will receive placebo ICS once a day at all other times during the study.
1057155|NCT00675584|P1|Participant Flow|Daily Budesonide|Participants will receive 0.5 mg of ICS (budesonide as Pulmicort Respules®) once a day at night, except during respiratory tract illnesses. During respiratory tract illnesses, participants will receive placebo each morning and 0.5 mg of budesonide each night for 7 days.
1057156|NCT00675584|O2|Outcome|Intermittent Budesonide|Participants will receive 1 mg of ICS (budesonide as Pulmicort Respules®) twice a day for 7 days at the onset of a respiratory tract illness; they will receive placebo ICS once a day at all other times during the study.
1057157|NCT00675584|O1|Outcome|Daily Budesonide|Participants will receive 0.5 mg of ICS (budesonide as Pulmicort Respules®) once a day at night, except during respiratory tract illnesses. During respiratory tract illnesses, participants will receive placebo each morning and 0.5 mg of budesonide each night for 7 days.
1057158|NCT00675584|E2|Reported Event|Intermittent Budesonide|Participants will receive 1 mg of ICS (budesonide as Pulmicort Respules®) twice a day for 7 days at the onset of a respiratory tract illness; they will receive placebo ICS once a day at all other times during the study.
1057159|NCT00675584|E1|Reported Event|Daily Budesonide|Participants will receive 0.5 mg of ICS (budesonide as Pulmicort Respules®) once a day at night, except during respiratory tract illnesses. During respiratory tract illnesses, participants will receive placebo each morning and 0.5 mg of budesonide each night for 7 days.
1057160|NCT00675558|B4|Baseline|Total|Total of all reporting groups
1057161|NCT00675558|B3|Baseline|Super-morbidly Obese (SMO)|Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.
1057162|NCT00675558|B2|Baseline|Morbidly Obese (MO)|Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
1057163|NCT00675558|B1|Baseline|Non-Obese (NO)|Non obese patients. Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
1057164|NCT00675558|P3|Participant Flow|Super-morbidly Obese (SMO)|"Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.~10 subjects of the original 30 subjects enrolled into this group received a second bariatric procedure. The remaining 20 subjects of the original 30 subjects did not continue on to the second phase (initial bariatric surgery) of the study."
1057165|NCT00675558|P2|Participant Flow|Morbidly Obese (MO)|Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
1057166|NCT00675558|P1|Participant Flow|Non-Obese (NO)|Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
1057167|NCT00675558|O3|Outcome|Super-morbidly Obese (SMO)|Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.
1057168|NCT00675558|O2|Outcome|Morbidly Obese (MO)|Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
1057169|NCT00675558|O1|Outcome|Non-Obese (NO)|Non obese patients. Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
1057170|NCT00675558|O3|Outcome|Super-morbidly Obese (SMO)|Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.
1057171|NCT00675558|O2|Outcome|Morbidly Obese (MO)|Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
1057172|NCT00675558|O1|Outcome|Non-Obese (NO)|Non obese patients. Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
1057173|NCT00675558|O3|Outcome|Super-morbidly Obese (SMO)|Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.
1057174|NCT00675558|O2|Outcome|Morbidly Obese (MO)|Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
1057175|NCT00675558|O1|Outcome|Non-Obese (NO)|Non obese patients. Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
1057176|NCT00675558|E3|Reported Event|Super-morbidly Obese (SMO)|Patients with a BMI > 50.0 scheduled for clinically indicated laparoscopic abdominal surgery.
1057177|NCT00675558|E2|Reported Event|Morbidly Obese (MO)|Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.
1057178|NCT00675558|E1|Reported Event|Non-Obese (NO)|Non obese patients. Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.
1057179|NCT00675506|B3|Baseline|Total|Total of all reporting groups
1057180|NCT00675506|B2|Baseline|Placebo|"Participants received treatment with placebo medication.~Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months"
1057181|NCT00675506|B1|Baseline|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).~Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months"
1057182|NCT00675506|P2|Participant Flow|Placebo|"Participants received treatment with placebo medication.~Placebo : 2-mg sub-cutaneous abdominal injections once daily for 12 months"
1057183|NCT00675506|P1|Participant Flow|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).~Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months"
1057184|NCT00675506|O2|Outcome|Placebo|"Participants received treatment with placebo medication.~Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months"
1057185|NCT00675506|O1|Outcome|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).~TH9507: Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months"
1057186|NCT00675506|O2|Outcome|Placebo|"Participants received treatment with placebo medication.~Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months"
1057187|NCT00675506|O1|Outcome|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).~TH9507: Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months."
1057188|NCT00675506|O2|Outcome|Placebo|"Participants received treatment with placebo medication.~Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months"
1057189|NCT00675506|O1|Outcome|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).~TH9507: Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months."
1057190|NCT00675506|O2|Outcome|Placebo|"Participants received treatment with placebo medication.~Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months"
1057191|NCT00675506|O1|Outcome|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).~TH9507: Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months."
1057192|NCT00675506|E2|Reported Event|Placebo|"Participants received treatment with placebo medication.~Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months"
1057193|NCT00675506|E1|Reported Event|TH9507|"Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).~Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months"
1057194|NCT00675441|B1|Baseline|Lenalidomide|Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
1057195|NCT00675441|P1|Participant Flow|Lenalidomide|Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
1057196|NCT00675441|O1|Outcome|Lenalidomide|Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
1057197|NCT00675441|E1|Reported Event|Lenalidomide|Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
1057198|NCT00675428|B3|Baseline|Total|Total of all reporting groups
1057199|NCT00675428|B2|Baseline|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
1057200|NCT00675428|B1|Baseline|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
1057201|NCT00675428|P2|Participant Flow|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
1057202|NCT00675428|P1|Participant Flow|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
1057203|NCT00675428|O2|Outcome|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
1057204|NCT00675428|O1|Outcome|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
1057205|NCT00675428|O2|Outcome|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
1057206|NCT00675428|O1|Outcome|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
1057207|NCT00675428|O2|Outcome|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
1057208|NCT00675428|O1|Outcome|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
1057209|NCT00675428|O2|Outcome|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
1057210|NCT00675428|O1|Outcome|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
1057211|NCT00675428|O2|Outcome|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
1057212|NCT00675428|O1|Outcome|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
1057213|NCT00675428|O2|Outcome|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
1057214|NCT00675428|O1|Outcome|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
1057215|NCT00675428|O2|Outcome|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
1057216|NCT00675428|O1|Outcome|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
1057217|NCT00675428|E2|Reported Event|Natalizumab 450 mg|Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
1057218|NCT00675428|E1|Reported Event|Natalizumab 300 mg|Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
1057219|NCT00675415|B3|Baseline|Total|Total of all reporting groups
1057220|NCT00675415|B2|Baseline|Standard Monitoring|Subjects randomized to capnography-blinded arm: In this arm, the endoscopy team will not have the graphic representation of respiratory activity (capnography) as well as end-expiratory levels of carbon dioxide available. Only a standard of care physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography at the disposal of the endoscopy team to titrate the sedative medications.
1057221|NCT00675415|B1|Baseline|Capnography|"Capnography: Subjects randomized to capnography-titration arm: The endoscopy team would be made aware of the capnographic abnormalities as they arise.~In this arm, the endoscopy team will have the graphic representation of respiratory activity (capnography) as well as end-epxiratory levels of carbon dioxide in addition to the normal physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography.~This observation phase would take place for a baseline prior to sedation, during the administration of sedation as well as throughout the procedure. Monitoring for the study would stop upon completion of the endoscopic procedure.~Capnography: Capnography: Passive measurement of carbon dioxide via a special bite block which allows graphic assessment of the subject's respiratory activity"
1057222|NCT00675415|P2|Participant Flow|Standard Monitoring|Subjects randomized to capnography-blinded arm: In this arm, the endoscopy team will not have the graphic representation of respiratory activity (capnography) as well as end-expiratory levels of carbon dioxide available. Only a standard of care physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography at the disposal of the endoscopy team to titrate the sedative medications.
1057223|NCT00675415|P1|Participant Flow|Capnography|"Capnography: Subjects randomized to capnography-titration arm: The endoscopy team would be made aware of the capnographic abnormalities as they arise.~In this arm, the endoscopy team will have the graphic representation of respiratory activity (capnography) as well as end-epxiratory levels of carbon dioxide in addition to the normal physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography.~This observation phase would take place for a baseline prior to sedation, during the administration of sedation as well as throughout the procedure. Monitoring for the study would stop upon completion of the endoscopic procedure.~Capnography: Capnography: Passive measurement of carbon dioxide via a special bite block which allows graphic assessment of the subject's respiratory activity"
1057224|NCT00675415|O2|Outcome|Standard Monitoring|Subjects randomized to capnography-blinded arm: In this arm, the endoscopy team will not have the graphic representation of respiratory activity (capnography) as well as end-expiratory levels of carbon dioxide available. Only a standard of care physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography at the disposal of the endoscopy team to titrate the sedative medications.
1057225|NCT00675415|O1|Outcome|Capnography|"Capnography: Subjects randomized to capnography-titration arm: The endoscopy team would be made aware of the capnographic abnormalities as they arise.~In this arm, the endoscopy team will have the graphic representation of respiratory activity (capnography) as well as end-epxiratory levels of carbon dioxide in addition to the normal physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography.~This observation phase would take place for a baseline prior to sedation, during the administration of sedation as well as throughout the procedure. Monitoring for the study would stop upon completion of the endoscopic procedure.~Capnography: Capnography: Passive measurement of carbon dioxide via a special bite block which allows graphic assessment of the subject's respiratory activity"
1057226|NCT00675415|E2|Reported Event|Standard Monitoring|Subjects randomized to capnography-blinded arm: In this arm, the endoscopy team will not have the graphic representation of respiratory activity (capnography) as well as end-expiratory levels of carbon dioxide available. Only a standard of care physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography at the disposal of the endoscopy team to titrate the sedative medications.
1057227|NCT00675415|E1|Reported Event|Capnography|"Capnography: Subjects randomized to capnography-titration arm: The endoscopy team would be made aware of the capnographic abnormalities as they arise.~In this arm, the endoscopy team will have the graphic representation of respiratory activity (capnography) as well as end-epxiratory levels of carbon dioxide in addition to the normal physiologic monitoring portfolio of pulse oximetry, blood pressure and electrocradiography.~This observation phase would take place for a baseline prior to sedation, during the administration of sedation as well as throughout the procedure. Monitoring for the study would stop upon completion of the endoscopic procedure.~Capnography: Capnography: Passive measurement of carbon dioxide via a special bite block which allows graphic assessment of the subject's respiratory activity"
1057228|NCT00675259|B1|Baseline|Neoadjuvant, Surgery, Adjuvant|Neoadjuvant chemotherapy : Nab-paclitaxel and carboplatin on days 1, 8, and 15 in combination with bevacizumab on days 1 and 15 administered every 28 days for 5 cycles followed by 1 cycle with Nab-paclitaxel and carboplatin on days 1, 8, and 15. Definitive surgery with either lumpectomy or mastectomy along with axillary lymph node dissection for all pre neo adjuvant chemotherapy node-positive patients approximately 4-5 weeks after the completion of NCT (Neoadjuvant chemotherapy). Use of additional adjuvant chemotherapy and/or radiation therapy depends upon the treating physicians’ judgment. Radiation therapy should begin no sooner than 6 weeks after breast cancer surgery. All hormone receptor positive patients will receive endocrine therapy. All patients will receive 6 months of adjuvant bevacizumab every 3 weeks. If using an adjuvant anthracycline-containing regimen then bevacizumab will be administered ≥ 3 weeks after completing the regimen.
1057229|NCT00675259|P1|Participant Flow|Neoadjuvant, Surgery, Adjuvant|Neoadjuvant chemotherapy : Nab-paclitaxel and carboplatin on days 1, 8, and 15 in combination with bevacizumab on days 1 and 15 administered every 28 days for 5 cycles followed by 1 cycle with Nab-paclitaxel and carboplatin on days 1, 8, and 15. Definitive surgery with either lumpectomy or mastectomy along with axillary lymph node dissection for all pre neo adjuvant chemotherapy node-positive patients approximately 4-5 weeks after the completion of NCT (Neoadjuvant chemotherapy). Use of additional adjuvant chemotherapy and/or radiation therapy depends upon the treating physicians’ judgment. Radiation therapy should begin no sooner than 6 weeks after breast cancer surgery. All hormone receptor positive patients will receive endocrine therapy. All patients will receive 6 months of adjuvant bevacizumab every 3 weeks. If using an adjuvant anthracycline-containing regimen then bevacizumab will be administered ≥ 3 weeks after completing the regimen.
1057230|NCT00675259|O3|Outcome|Patients With Hormone-responsive BC|Hormone-responsive breast cancer (BC)
1057231|NCT00675259|O2|Outcome|Patients With pCR|Pathologic complete response (pCR)
1057232|NCT00675259|O1|Outcome|Patients With TNBC|Women with triple negative breast cancer (TNBC)
1057233|NCT00675259|O1|Outcome|Neoadjuvant, Surgery, Adjuvant|Neoadjuvant chemotherapy : Nab-paclitaxel and carboplatin on days 1, 8, and 15 in combination with bevacizumab on days 1 and 15 administered every 28 days for 5 cycles followed by 1 cycle with Nab-paclitaxel and carboplatin on days 1, 8, and 15. Definitive surgery with either lumpectomy or mastectomy along with axillary lymph node dissection for all pre neo adjuvant chemotherapy node-positive patients approximately 4-5 weeks after the completion of NCT. Use of additional adjuvant chemotherapy and/or radiation therapy depends upon the treating physicians’ judgment. Radiation therapy should begin no sooner than 6 weeks after breast cancer surgery. All hormone receptor positive patients will receive endocrine therapy. All patients will receive 6 months of adjuvant bevacizumab every 3 weeks. If using an adjuvant anthracycline-containing regimen then bevacizumab will be administered ≥ 3 weeks after completing the regimen.
1057234|NCT00675259|O1|Outcome|Adjuvant Bevacizumab|Patients received 6 months of adjuvant bevacizumab therapy
1057235|NCT00675259|O1|Outcome|Neoadjuvant, Surgery, Adjuvant|Neoadjuvant chemotherapy : Nab-paclitaxel and carboplatin on days 1, 8, and 15 in combination with bevacizumab on days 1 and 15 administered every 28 days for 5 cycles followed by 1 cycle with Nab-paclitaxel and carboplatin on days 1, 8, and 15. Definitive surgery with either lumpectomy or mastectomy along with axillary lymph node dissection for all pre neo adjuvant chemotherapy node-positive patients approximately 4-5 weeks after the completion of NCT. Use of additional adjuvant chemotherapy and/or radiation therapy depends upon the treating physicians’ judgment. Radiation therapy should begin no sooner than 6 weeks after breast cancer surgery. All hormone receptor positive patients will receive endocrine therapy. All patients will receive 6 months of adjuvant bevacizumab every 3 weeks. If using an adjuvant anthracycline-containing regimen then bevacizumab will be administered ≥ 3 weeks after completing the regimen.
1057236|NCT00675259|E1|Reported Event|Toxicities During Neoadjuvant Chemotherapy|
1057237|NCT00675103|B1|Baseline|Pegloticase 8 mg Every 2 Wks|
1057238|NCT00675103|P1|Participant Flow|Pegloticase 8 mg Every 2 Wks|
1057239|NCT00675103|O1|Outcome|Pegloticase 8 mg Every 2 Wks|
1057240|NCT00675103|O1|Outcome|Pegloticase 8 mg Every 2 Wks|
1057241|NCT00675103|E1|Reported Event|Pegloticase 8 mg Every 2 Wks|
1057242|NCT00674986|B3|Baseline|Total|Total of all reporting groups
1057243|NCT00674986|B2|Baseline|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
1057244|NCT00674986|B1|Baseline|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
1057245|NCT00674986|P2|Participant Flow|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
1057246|NCT00674986|P1|Participant Flow|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
1057247|NCT00674986|O1|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
1057248|NCT00674986|O2|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
1057249|NCT00674986|O1|Outcome|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
1057250|NCT00674986|O2|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
1057251|NCT00674986|O1|Outcome|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
1057252|NCT00674986|O2|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
1057253|NCT00674986|O1|Outcome|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
1057254|NCT00674986|O2|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
1057255|NCT00674986|O1|Outcome|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
1057256|NCT00674986|O2|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
1057257|NCT00674986|O1|Outcome|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
1057439|NCT00674739|B1|Baseline|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
1057440|NCT00674739|P3|Participant Flow|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks
1057258|NCT00674986|O2|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
1057259|NCT00674986|O1|Outcome|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
1057260|NCT00674986|O2|Outcome|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
1057261|NCT00674986|O1|Outcome|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
1057262|NCT00674986|E2|Reported Event|Active Control Group (ACG)|Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
1057263|NCT00674986|E1|Reported Event|Structured Testing Group (STG)|Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
1057264|NCT00674973|B3|Baseline|Total|Total of all reporting groups
1057265|NCT00674973|B2|Baseline|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
1057266|NCT00674973|B1|Baseline|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
1057267|NCT00674973|P2|Participant Flow|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
1057268|NCT00674973|P1|Participant Flow|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
1057269|NCT00674973|O2|Outcome|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
1057270|NCT00674973|O1|Outcome|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
1057271|NCT00674973|O2|Outcome|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
1057272|NCT00674973|O1|Outcome|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
1057273|NCT00674973|O2|Outcome|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
1057274|NCT00674973|O1|Outcome|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
1057275|NCT00674973|O2|Outcome|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
1057276|NCT00674973|O1|Outcome|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
1057277|NCT00674973|O2|Outcome|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
1057278|NCT00674973|O1|Outcome|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
1057279|NCT00674973|E2|Reported Event|Erlotinib|Participants with advanced pancreatic carcinoma with ECOG PS score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received erlotinib 150 mg orally once daily until PD, unacceptable toxicity, withdrawal, or death.
1057280|NCT00674973|E1|Reported Event|Placebo|Participants with advanced pancreatic carcinoma with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2, who had failed 1 prior regimen of chemotherapy or who were considered unsuitable for chemotherapy, received placebo matching to erlotinib 150 mg tablet orally once daily until disease progression (PD), unacceptable toxicity, withdrawal, or death.
1057281|NCT00674817|B1|Baseline|Total Population|Eligible participants received GSK961981 400 micrograms (mcg) and 1200 mcg metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3x 200 mcg at 0 min intervals, administered via spacer) of salbutamol at 1hour (h), 12h and 24h of dosing during first and second treatment periods, respectively. Eligible participants received GSK961981 400 mcg and 1200 mcg followed by cumulative doses (20 mcg , 20 mcg and 40 mcg at 20 minutes intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing during third and forth treatment period, respectively. Eligible participants received GSK961981 400 mcg and 1200 mcg followed by cumulative doses (3 doses at 20 minutes intervals, administered via spacer) of Placebo at 1h, 12h and 24h of dosing during fifth and sixth treatment period, respectively.
1057282|NCT00674817|P1|Participant Flow|Total Population|Eligible participants received GSK961981 400 micrograms (mcg) and 1200 mcg metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3x 200 mcg at 0 min intervals, administered via spacer) of salbutamol at 1hour (h), 12h and 24h of dosing during first and second treatment periods, respectively. Eligible participants received GSK961981 400 mcg and 1200 mcg followed by cumulative doses (20 mcg , 20 mcg and 40 mcg at 20 minutes intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing during third and forth treatment period, respectively. Eligible participants received GSK961981 400 mcg and 1200 mcg followed by cumulative doses (3 doses at 20 minutes intervals, administered via spacer) of Placebo at 1h, 12h and 24h of dosing during fifth and sixth treatment period, respectively.
1057283|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057284|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057285|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057286|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057287|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057288|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057289|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057290|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057291|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057292|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057293|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057294|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057295|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057296|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057297|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057298|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057299|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057300|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057435|NCT00674765|E1|Reported Event|Seroquel|"Seroquel~Seroquel: 400 mg/day"
1057436|NCT00674739|B4|Baseline|Total|Total of all reporting groups
1057301|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057302|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057303|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057304|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057305|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057306|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057307|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057308|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057309|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057310|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057311|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057312|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057313|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057314|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057315|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057316|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057317|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057318|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057319|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057320|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057321|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057322|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057323|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057324|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057325|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057326|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057327|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057328|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057329|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057330|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057331|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057332|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057333|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057334|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057335|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057336|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057337|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057338|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057339|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057340|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057341|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057342|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057343|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057344|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057345|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057346|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057347|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057348|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057349|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057350|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057351|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057437|NCT00674739|B3|Baseline|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks
1057438|NCT00674739|B2|Baseline|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
1057352|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057353|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057354|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057355|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057356|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057357|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057358|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057359|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057360|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057361|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057362|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057363|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057364|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057365|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057366|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057367|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057368|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057369|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057370|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057371|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057372|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057373|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057374|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057375|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057376|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057377|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057378|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057379|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057380|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057381|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057382|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057383|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057384|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057385|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057386|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057387|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057388|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057389|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057390|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057391|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057392|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057393|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057394|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057395|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057396|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057397|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057398|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057399|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057400|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057401|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057402|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057403|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057404|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057405|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057406|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057407|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057408|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057409|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057410|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057411|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057412|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057413|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057414|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057415|NCT00674817|O6|Outcome|GSK961081 1200 mg Plus Placebo|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057416|NCT00674817|O5|Outcome|GSK961081 400 mg Plus Placebo|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057417|NCT00674817|O4|Outcome|GSK961081 1200 mg Plus IPR|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg, and 40 mcg at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057418|NCT00674817|O3|Outcome|GSK961081 400 mg Plus IPR|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 mcg, 20 mcg and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057419|NCT00674817|O2|Outcome|GSK961081 1200 mg Plus SAL|Eligible participants received 1200 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057420|NCT00674817|O1|Outcome|GSK961081 400 mg Plus SAL|Eligible participants received 400 mcg of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 mcg at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057421|NCT00674817|E6|Reported Event|1200 Microgrammes of GSK961081 and Placebo|1200 microgrammes of GSK961081 single-dose (via DISKUS Metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057422|NCT00674817|E5|Reported Event|400 Microgrammes of GSK961081 and Placebo|400 microgrammes of GSK961081 single-dose (via DISKUS Metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing.
1057423|NCT00674817|E4|Reported Event|1200 Microgrammes of GSK961081 and Ipratropium Bromide|1200 microgrammes of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 microgrammes, 20 microgrammes and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057424|NCT00674817|E3|Reported Event|400 Microgrammes GSK961081 and Ipratropium Bromide|400 microgrammes of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 microgrammes, 20 microgrammes and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing.
1057425|NCT00674817|E2|Reported Event|1200 Microgrammes GSK961081 and Salbutamol|1200 microgrammes of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 microgrammes at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057426|NCT00674817|E1|Reported Event|400 Microgrammes GSK961081 and Salbutamol|400 microgrammes of GSK961081 single-dose (via DISKUS Metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3x 200 microgrammes at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing.
1057427|NCT00674765|B3|Baseline|Total|Total of all reporting groups
1057428|NCT00674765|B2|Baseline|Placebo|"Placebo~Placebo: 400 mg/day"
1057429|NCT00674765|B1|Baseline|Seroquel|"Seroquel~Seroquel: 400 mg/day"
1057430|NCT00674765|P2|Participant Flow|Placebo|"Placebo~Placebo: 400 mg/day"
1057431|NCT00674765|P1|Participant Flow|Seroquel|"Seroquel~Seroquel: 400 mg/day"
1057432|NCT00674765|O2|Outcome|Placebo Sugar Pill|"Placebo~Placebo: 400 mg/day"
1057433|NCT00674765|O1|Outcome|Seroquel (Quetiapine)|"Seroquel (quetiapine)~Seroquel: 400 mg/day"
1057441|NCT00674739|P2|Participant Flow|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
1057442|NCT00674739|P1|Participant Flow|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
1057443|NCT00674739|O3|Outcome|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks
1057444|NCT00674739|O2|Outcome|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
1057445|NCT00674739|O1|Outcome|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
1057446|NCT00674739|O3|Outcome|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks
1057447|NCT00674739|O2|Outcome|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
1057448|NCT00674739|O1|Outcome|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
1057449|NCT00674739|O3|Outcome|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks
1057450|NCT00674739|O2|Outcome|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
1057451|NCT00674739|O1|Outcome|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
1057452|NCT00674739|E3|Reported Event|Placebo|Placebo cream applied once daily to wart areas for up to 8 weeks
1057453|NCT00674739|E2|Reported Event|3.75% Imiquimod Cream|3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
1057454|NCT00674739|E1|Reported Event|2.5% Imiquimod Cream|2.5% imiquimod cream applied once daily to wart areas for up to 8 weeks
1057455|NCT00674700|B4|Baseline|Total|Total of all reporting groups
1057456|NCT00674700|B3|Baseline|Placebo|Placebo tablet
1057457|NCT00674700|B2|Baseline|500 IR|500 IR house dust mites allergen extract tablet
1057458|NCT00674700|B1|Baseline|300 IR|300 IR house dust mites allergen extract tablet
1057459|NCT00674700|P3|Participant Flow|Placebo|Placebo tablet
1057460|NCT00674700|P2|Participant Flow|500 IR|500 IR house dust mites allergen extract tablet
1057461|NCT00674700|P1|Participant Flow|300 IR|300 IR house dust mites allergen extract tablet
1057462|NCT00674700|O3|Outcome|Placebo|Placebo tablet
1057463|NCT00674700|O2|Outcome|500 IR|500 IR house dust mites allergen extract tablet
1057464|NCT00674700|O1|Outcome|300 IR|300 IR house dust mites allergen extract tablet
1057465|NCT00674700|O3|Outcome|Placebo|Placebo tablet
1057466|NCT00674700|O2|Outcome|500 IR|500 IR house dust mites allergen extract tablet
1057467|NCT00674700|O1|Outcome|300 IR|300 IR house dust mites allergen extract tablet
1057468|NCT00674700|E3|Reported Event|Placebo|Placebo tablet
1057469|NCT00674700|E2|Reported Event|500 IR|500 IR house dust mites allergen extract tablet
1057470|NCT00674700|E1|Reported Event|300 IR|300 IR house dust mites allergen extract tablet
1057471|NCT00674661|B3|Baseline|Total|Total of all reporting groups
1057472|NCT00674661|B2|Baseline|Control Group|riboflavin opthalmic solution without UVA irradiation
1057473|NCT00674661|B1|Baseline|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
1057474|NCT00674661|P2|Participant Flow|Control Group|riboflavin opthalmic solution without UVA irradiation
1057475|NCT00674661|P1|Participant Flow|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
1057476|NCT00674661|O2|Outcome|Control Group|riboflavin opthalmic solution without UVA irradiation
1057477|NCT00674661|O1|Outcome|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
1057478|NCT00674661|E2|Reported Event|Control Group|riboflavin opthalmic solution without UVA irradiation
1057479|NCT00674661|E1|Reported Event|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
1057480|NCT00674622|B4|Baseline|Total|Total of all reporting groups
1057481|NCT00674622|B3|Baseline|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
1057482|NCT00674622|B2|Baseline|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
1057483|NCT00674622|B1|Baseline|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
1057484|NCT00674622|P3|Participant Flow|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
1057485|NCT00674622|P2|Participant Flow|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
1057486|NCT00674622|P1|Participant Flow|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
1057487|NCT00674622|O3|Outcome|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
1057488|NCT00674622|O2|Outcome|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
1057489|NCT00674622|O1|Outcome|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
1057490|NCT00674622|O3|Outcome|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
1057491|NCT00674622|O2|Outcome|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
1057492|NCT00674622|O1|Outcome|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
1057493|NCT00674622|O3|Outcome|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
1057494|NCT00674622|O2|Outcome|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
1057495|NCT00674622|O1|Outcome|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
1057496|NCT00674622|O3|Outcome|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
1057497|NCT00674622|O2|Outcome|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
1057498|NCT00674622|O1|Outcome|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
1063203|NCT00661492|E1|Reported Event|Arm 1|Novantrone+Erbitux
1057499|NCT00674622|O3|Outcome|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
1057500|NCT00674622|O2|Outcome|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
1057501|NCT00674622|O1|Outcome|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
1057502|NCT00674622|E3|Reported Event|Group 3-Superficial Saline/Lidocaine|Superficial injection with saline/lidocaine
1057503|NCT00674622|E2|Reported Event|Group 2-Deep Saline/Lidocaine|Deep injection with saline/lidocaine
1057504|NCT00674622|E1|Reported Event|Group 1-Prolotherapy|Deep injection with 15% dextrose in lidocaine
1057505|NCT00674609|B4|Baseline|Total|Total of all reporting groups
1057506|NCT00674609|B3|Baseline|Placebo|Each 100 uL actuation contained colourant and excipients
1057507|NCT00674609|B2|Baseline|THC Alone|Each 100 uL actuation contained 27 mg/ml THC
1057508|NCT00674609|B1|Baseline|Sativex|Each 100 uL actuation contained 27 mg/ml THC and 25 mg/ml CBD
1057509|NCT00674609|P3|Participant Flow|Placebo|Each 100 uL actuation contained colourant and excipients
1057510|NCT00674609|P2|Participant Flow|THC Alone|Each 100 uL actuation contained 27 mg/ml THC
1057511|NCT00674609|P1|Participant Flow|Sativex|Each 100 uL actuation contained 27 mg/ml THC and 25 mg/ml CBD
1057512|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
1057513|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
1057514|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
1057515|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
1057516|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
1057517|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
1057518|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
1057519|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
1057520|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
1057521|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
1057522|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
1057523|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
1057524|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
1057525|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
1057526|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
1057527|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
1057528|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
1057529|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
1057530|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
1057531|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
1057532|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
1057574|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
1057533|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
1057534|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
1057535|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
1057536|NCT00674609|O3|Outcome|Placebo|Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
1057537|NCT00674609|O2|Outcome|THC Alone|Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
1057538|NCT00674609|O1|Outcome|Sativex|Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
1057539|NCT00674609|E3|Reported Event|Placebo|Maximum number of daily sprays was 48
1057540|NCT00674609|E2|Reported Event|THC Alone|Maximum number of daily sprays was 48 giving a maximum daily dose of 130 mg THC
1057541|NCT00674609|E1|Reported Event|Sativex|Maximum number of daily sprays was 48 giving a maximum daily dose of 130 mg THC and 120 mg CBD
1057542|NCT00674492|B1|Baseline|Group 1|patients who initiated antiviral treatment for hepatitis C
1057543|NCT00674492|P1|Participant Flow|Group 1|patients who initiated antiviral treatment for hepatitis C
1057544|NCT00674492|O1|Outcome|Group 1|patients who initiated antiviral treatment for hepatitis C
1057545|NCT00674492|E1|Reported Event|Group 1|patients who initiated antiviral treatment for hepatitis C
1057546|NCT00674466|B4|Baseline|Total|Total of all reporting groups
1057547|NCT00674466|B3|Baseline|Placebo|"Twice-a-week placebo for CJC-1134-PC~Placebo: twice-a-week"
1057548|NCT00674466|B2|Baseline|1.5 mg or 2.0 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC for 4 weeks, then once-a-week dose of 2.0 mg CJC-1134-PC plus mid-week dosing of placebo~1.5 mg or 2.0 mg CJC-1134-PC: twice-a-week"
1057549|NCT00674466|B1|Baseline|1.5 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC~1.5 mg CJC-1134-PC: twice-a-week"
1057550|NCT00674466|P3|Participant Flow|Placebo|"Twice-a-week placebo for CJC-1134-PC~Placebo: twice-a-week"
1057551|NCT00674466|P2|Participant Flow|1.5 mg or 2.0 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC for 4 weeks, then once-a-week dose of 2.0 mg CJC-1134-PC plus mid-week dosing of placebo~1.5 mg or 2.0 mg CJC-1134-PC: twice-a-week"
1057552|NCT00674466|P1|Participant Flow|1.5 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC~1.5 mg CJC-1134-PC: twice-a-week"
1057553|NCT00674466|O3|Outcome|Placebo|"Twice-a-week placebo for CJC-1134-PC~Placebo: twice-a-week"
1057554|NCT00674466|O2|Outcome|1.5 mg or 2.0 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC for 4 weeks, then once-a-week dose of 2.0 mg CJC-1134-PC plus mid-week dosing of placebo~1.5 mg or 2.0 mg CJC-1134-PC: twice-a-week"
1057555|NCT00674466|O1|Outcome|1.5 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC~1.5 mg CJC-1134-PC: twice-a-week"
1057556|NCT00674466|O3|Outcome|Placebo|"Twice-a-week placebo for CJC-1134-PC~Placebo: twice-a-week"
1057557|NCT00674466|O2|Outcome|1.5 mg or 2.0 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC for 4 weeks, then once-a-week dose of 2.0 mg CJC-1134-PC plus mid-week dosing of placebo~1.5 mg or 2.0 mg CJC-1134-PC: twice-a-week"
1057558|NCT00674466|O1|Outcome|1.5 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC~1.5 mg CJC-1134-PC: twice-a-week"
1057559|NCT00674466|O3|Outcome|Placebo|"Twice-a-week placebo for CJC-1134-PC~Placebo: twice-a-week"
1057560|NCT00674466|O2|Outcome|1.5 mg or 2.0 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC for 4 weeks, then once-a-week dose of 2.0 mg CJC-1134-PC plus mid-week dosing of placebo~1.5 mg or 2.0 mg CJC-1134-PC: twice-a-week"
1057561|NCT00674466|O1|Outcome|1.5 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC~1.5 mg CJC-1134-PC: twice-a-week"
1057562|NCT00674466|E3|Reported Event|Placebo|"Twice-a-week placebo for CJC-1134-PC~Placebo: twice-a-week"
1057563|NCT00674466|E2|Reported Event|1.5 mg or 2.0 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC for 4 weeks, then once-a-week dose of 2.0 mg CJC-1134-PC plus mid-week dosing of placebo~1.5 mg or 2.0 mg CJC-1134-PC: twice-a-week"
1057564|NCT00674466|E1|Reported Event|1.5 mg CJC-1134-PC|"Twice-a-week dose of 1.5 mg CJC-1134-PC~1.5 mg CJC-1134-PC: twice-a-week"
1057565|NCT00674362|B3|Baseline|Total|Total of all reporting groups
1057566|NCT00674362|B2|Baseline|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
1057567|NCT00674362|B1|Baseline|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
1057568|NCT00674362|P2|Participant Flow|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
1057569|NCT00674362|P1|Participant Flow|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
1057570|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
1057571|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
1057572|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
1057573|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
1057575|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
1057576|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
1057577|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
1057578|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
1057579|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
1057580|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
1057581|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
1057582|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
1057583|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
1057584|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
1057585|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
1057586|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
1057587|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
1057588|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
1057589|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
1057590|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
1057591|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
1057592|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
1057593|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
1057594|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
1057595|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
1057596|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
1057597|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
1057598|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
1057599|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
1057600|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
1057601|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
1057602|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
1057603|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
1057604|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
1057605|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
1057606|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
1057607|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
1057672|NCT00674128|P2|Participant Flow|Suture|Polyglactin 910 suture.
1057608|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
1057609|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
1057610|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
1057611|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
1057612|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
1057613|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
1057614|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
1057615|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
1057616|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
1057617|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
1057618|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
1057619|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
1057620|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
1057621|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
1057622|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
1057623|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
1057624|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
1057625|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
1057626|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
1057627|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
1057628|NCT00674362|O2|Outcome|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
1057629|NCT00674362|O1|Outcome|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
1057630|NCT00674362|E3|Reported Event|Open Label Phase|At Week 24 subjects are evaluated. Non-remitters are discontinued from the study with the opportunity to enter another open label (OL) study. Remitters stop randomized treatment and are followed up until Week 52. Remitters who flare up between Week 24 and Week 52 will be re-treated with (3 administrations of 400 mg CZP, given every other week, followed by 200 mg CZP given every other week) up to and including Week 50. Of the 27 subjects in the OL phase 15 were retreated and 12 were not retreated.
1057631|NCT00674362|E2|Reported Event|Placebo|Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
1057632|NCT00674362|E1|Reported Event|Certolizumab Pegol 200 mg (CDP870)|Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)
1057633|NCT00674323|B4|Baseline|Total|Total of all reporting groups
1057634|NCT00674323|B3|Baseline|Ranibizumab Monotherapy|Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
1057635|NCT00674323|B2|Baseline|Verteporfin Monotherapy|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
1057673|NCT00674128|P1|Participant Flow|Adhesive|Cyanoacrylate tissue adhesive.
1057677|NCT00674128|E1|Reported Event|Adhesive|Cyanoacrylate tissue adhesive.
1057678|NCT00674115|B1|Baseline|Entire Study Population|
1057636|NCT00674323|B1|Baseline|Verteporfin and Ranibizumab|Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
1057637|NCT00674323|P3|Participant Flow|Ranibizumab Monotherapy|Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
1057638|NCT00674323|P2|Participant Flow|Verteporfin Monotherapy|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
1057639|NCT00674323|P1|Participant Flow|Verteporfin and Ranibizumab|Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
1057640|NCT00674323|O3|Outcome|Ranibizumab Monotherapy|Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
1057641|NCT00674323|O2|Outcome|Verteporfin Monotherapy|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
1057642|NCT00674323|O1|Outcome|Verteporfin and Ranibizumab|Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
1057643|NCT00674323|O3|Outcome|Ranibizumab Monotherapy|Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
1057644|NCT00674323|O2|Outcome|Verteporfin Monotherapy|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
1057645|NCT00674323|O1|Outcome|Verteporfin and Ranibizumab|Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
1057646|NCT00674323|O3|Outcome|Ranibizumab Monotherapy|Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
1057647|NCT00674323|O2|Outcome|Verteporfin Monotherapy|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
1057648|NCT00674323|O1|Outcome|Verteporfin and Ranibizumab|Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
1057649|NCT00674323|O3|Outcome|Ranibizumab Monotherapy|Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
1057650|NCT00674323|O2|Outcome|Verteporfin Monotherapy|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
1057651|NCT00674323|O1|Outcome|Verteporfin and Ranibizumab|Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
1057652|NCT00674323|E3|Reported Event|Ranibizumab Monotherapy|Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on ICGA, and assessment of fluorescein angiograms and visual acuity.
1057653|NCT00674323|E2|Reported Event|Verteporfin Monotherapy|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on ICGA, and assessment of fluorescein angiograms and visual acuity.
1057654|NCT00674323|E1|Reported Event|Verteporfin and Ranibizumab|Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on ICGA, and assessment of fluorescein angiograms and visual acuity.
1057655|NCT00674206|B1|Baseline|Single Arm Study|All patients enrolled on clinical trial will receive gemcitabine and oxaliplatin.
1057656|NCT00674206|P1|Participant Flow|Single Arm Study|All patients enrolled on clinical trial will receive gemcitabine and oxaliplatin.
1057657|NCT00674206|O1|Outcome|Gemcitabine and Oxaliplatin|All patients enrolled on clinical trial will receive Gemcitabine 1000mg/m^2 on Day 1 and Oxaliplatin 100 mg/m^2 intravenously over 2 hours on Day 2.
1057658|NCT00674206|O1|Outcome|Gemcitabine and Oxaliplatin|All patients enrolled on clinical trial will receive Gemcitabine 1000mg/m^2 on Day 1 and Oxaliplatin 100 mg/m^2 intravenously over 2 hours on Day 2.
1057659|NCT00674206|E1|Reported Event|Single Arm Study|All patients enrolled on clinical trial will receive gemcitabine and oxaliplatin.
1057660|NCT00674154|B3|Baseline|Total|Total of all reporting groups
1057661|NCT00674154|B2|Baseline|Placebo|Placebo, two tablets daily in 52 weeks.
1057662|NCT00674154|B1|Baseline|Vitamin D|Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks
1057663|NCT00674154|P2|Participant Flow|Placebo|Placebo, two tablets daily in 52 weeks.
1057664|NCT00674154|P1|Participant Flow|Vitamin D|Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks
1057665|NCT00674154|O2|Outcome|Placebo|Placebo, two tablets daily in 52 weeks.
1057666|NCT00674154|O1|Outcome|Vitamin D|Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks
1057667|NCT00674154|E2|Reported Event|Placebo|Placebo, two tablets daily in 52 weeks.
1057668|NCT00674154|E1|Reported Event|Vitamin D|Cholecalciferol 1400 IE, 2 tablets once daily in 52 weeks
1057669|NCT00674128|B3|Baseline|Total|Total of all reporting groups
1057670|NCT00674128|B2|Baseline|Suture|Polyglactin 910 suture.
1057671|NCT00674128|B1|Baseline|Adhesive|Cyanoacrylate tissue adhesive.
1057679|NCT00674115|P4|Participant Flow|Prilosec, Zegerid|Participants received Prilosec OTC Tablets (omeprazole 20 mg) in the first intervention and Zegerid Oral Suspension (omeprazole 20 mg and sodium bicarbonate 1680 mg) in the second intervention (after washout period)
1057680|NCT00674115|P3|Participant Flow|Zegerid, Prilosec|Participants received Zegerid Oral Suspension (omeprazole 20 mg and sodium bicarbonate 1680 mg) in the first intervention and Prilosec OTC Tablets (omeprazole 20 mg) in the second intervention (after washout period)
1057681|NCT00674115|P2|Participant Flow|Prilosec, Zegerid, Sodium Bicarbonate|Participants received Prilosec OTC Tablets (omeprazole 20 mg) in the first intervention, Zegerid Oral Suspension (omeprazole 20 mg and sodium bicarbonate 1680 mg) in the second intervention (after washout period), and Sodium Bicarbonate Oral Suspension (sodium bicarbonate 1680 mg) in the third intervention (after washout period)
1057682|NCT00674115|P1|Participant Flow|Zegerid, Prilosec, Sodium Bicarbonate|Participants received Zegerid Oral Suspension (omeprazole 20 mg and sodium bicarbonate 1680 mg) in the first intervention, Prilosec over-the-counter (OTC) Tablets (omeprazole 20 mg) in the second intervention (after washout period), and Sodium Bicarbonate Oral Suspension (sodium bicarbonate 1680 mg) in the third intervention (after washout period)
1057683|NCT00674115|O2|Outcome|Prilosec|Participants in the 7-Day Dosing group. Measurements taken on the 7th day of Prilosec administration.
1057684|NCT00674115|O1|Outcome|Zegerid|Participants in the 7-Day Dosing group. Measurements taken on the 7th day of Zegerid administration.
1057685|NCT00674115|E5|Reported Event|Prilosec (1-Day Dosing)|
1057686|NCT00674115|E4|Reported Event|Zegerid (1-Day Dosing)|
1057687|NCT00674115|E3|Reported Event|Sodium Bicarbonate (1-Day Dosing)|Following completion of the 1-day dosing 2-way crossover study, and a subsequent washout period (minimum of 2 weeks), all participants then received a single administration of sodium bicarbonate 1680 mg.
1057688|NCT00674115|E2|Reported Event|Prilosec (7-Day Dosing)|
1057689|NCT00674115|E1|Reported Event|Zegerid (7-Day Dosing)|
1057690|NCT00673959|B1|Baseline|Overall Study|
1057691|NCT00673959|P2|Participant Flow|Optive Drops, Then Lubricant Drops|Patients received Optive Drops first, then received Lubricant Drops
1057692|NCT00673959|P1|Participant Flow|Lubricant Drops, Then Optive Drops|Patients received Lubricant Drops first, then received Optive Drops
1057693|NCT00673959|O2|Outcome|Optive Lubricant Eye Drop|
1057694|NCT00673959|O1|Outcome|Lubricant Eye Drop FID 111421|
1057695|NCT00673959|E2|Reported Event|Optive Lubricant Eye Drop|
1057696|NCT00673959|E1|Reported Event|Lubricant Eye Drop FID 111421|
1057697|NCT00673933|B1|Baseline|Visonac and Vehicle Cream With PDT|Two areas on the back per patient was treated, one area with Visonac (Methyl aminolevulinate) and one with vehicle followed by red light illumination.
1057698|NCT00673933|P1|Participant Flow|Visonac Cream With PDT and Vehicle and PDT|Two areas on the back per patient was treated, one area with Visonac and one with vehicle. Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light
1057699|NCT00673933|O2|Outcome|Vehicle Cream With PDT|"PDT using Placebo cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
1057700|NCT00673933|O1|Outcome|Visonac Cream With PDT|"PDT using MAL cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
1057701|NCT00673933|O2|Outcome|Vehicle Cream With PDT|"PDT using Placebo cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
1057702|NCT00673933|O1|Outcome|Visonac Cream With PDT|"PDT using MAL cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
1057703|NCT00673933|O2|Outcome|Vehicle Cream With PDT|"PDT using Placebo cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
1057704|NCT00673933|O1|Outcome|Visonac Cream With PDT|"PDT using MAL cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
1057705|NCT00673933|O2|Outcome|Vehicle Cream With PDT|"PDT using Placebo cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
1057706|NCT00673933|O1|Outcome|Visonac Cream With PDT|"PDT using MAL cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
1057707|NCT00673933|O2|Outcome|Vehicle Cream With PDT|"PDT using Placebo cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
1057708|NCT00673933|O1|Outcome|Visonac Cream With PDT|"PDT using MAL cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
1057709|NCT00673933|O2|Outcome|Vehicle Cream With PDT|"PDT using Placebo cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
1057710|NCT00673933|O1|Outcome|Visonac Cream With PDT|"PDT using MAL cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
1057711|NCT00673933|E2|Reported Event|Vehicle Cream With PDT|"PDT using Placebo cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
1057712|NCT00673933|E1|Reported Event|Visonac Cream With PDT|"PDT using MAL cream~Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light"
1057713|NCT00673881|B1|Baseline|ABT 335|choline fenofibrate, 135 mg/day,orally, 12 weeks
1057714|NCT00673881|P1|Participant Flow|ABT 335|choline fenofibrate, 135 mg/day,orally, 12 weeks
1057715|NCT00673881|O1|Outcome|ABT 335|choline fenofibrate, 135 mg/day,orally, 12 weeks
1057716|NCT00673881|O1|Outcome|ABT 335|choline fenofibrate, 135 mg/day,orally, 12 weeks
1057717|NCT00673881|O1|Outcome|ABT 335|choline fenofibrate, 135 mg/day,orally, 12 weeks
1057718|NCT00673881|O1|Outcome|ABT 335|choline fenofibrate, 135 mg/day,orally, 12 weeks
1057719|NCT00673881|E1|Reported Event|ABT 335|choline fenofibrate, 135 mg/day,orally, 12 weeks
1057720|NCT00673855|B1|Baseline|Overall Study|
1057721|NCT00673855|P2|Participant Flow|Optive Drops, Then Lubricant Drops|Patients received Optive Drops first, then received Lubricant Drops
1057722|NCT00673855|P1|Participant Flow|Lubricant Drops, Then Optive Drops|Patients received lubricant Drops first, then received Optive Drops
1057724|NCT00673855|O1|Outcome|Lubricant Eye Drops FID 112903|Lubricant Eye Drops FID 112903
1057725|NCT00673855|E2|Reported Event|Lubricant Eye Drops|Lubricant Eye Drops
1057726|NCT00673855|E1|Reported Event|Lubricant Eye Drops FID 112903|Lubricant Eye Drops FID 112903
1057727|NCT00673816|B1|Baseline|Sunitinib Malate|Participants were expected to receive 9 months of sunitinib malate therapy administered in 6 cycles. Each cycle consisted of a daily oral dose of 50 mg sunitinib malate for 4 weeks followed by a 2-week rest period).
1057728|NCT00673816|P1|Participant Flow|Sunitinib Malate|Participants were expected to receive 9 months of sunitinib malate therapy administered in 6 cycles. Each cycle consisted of a daily oral dose of 50 mg sunitinib malate for 4 weeks followed by a 2-week rest period). Only one participant remained in the study for the Week 36 measures.
1057729|NCT00673816|O2|Outcome|Right Eye|
1057730|NCT00673816|O1|Outcome|Left Eye|
1057731|NCT00673816|O2|Outcome|Right Eye|
1057732|NCT00673816|O1|Outcome|Left Eye|
1057733|NCT00673816|E1|Reported Event|Sunitinib Malate|Participants were expected to receive 9 months of sunitinib malate therapy administered in 6 cycles. Each cycle consisted of a daily oral dose of 50 mg sunitinib malate for 4 weeks followed by a 2-week rest period). Only one participant remained in the study for the Week 36 measures.
1057734|NCT00673764|B1|Baseline|Overall Study|Overall Study
1057735|NCT00673764|P2|Participant Flow|Optive, Then Systane Ultra|Optive Lubricant Eye Drops first, then cross-over to Systane Ultra.
1057736|NCT00673764|P1|Participant Flow|Systane Ultra, Then Optive|Systane Ultra Lubricant Eye Drops first, then cross-over to Optive.
1057737|NCT00673764|O2|Outcome|Optive|Optive Lubricant Eye Drops
1057738|NCT00673764|O1|Outcome|Systane Ultra|Systane Ultra Lubricant Eye Drops.
1057739|NCT00673764|O2|Outcome|Optive|Optive Lubricant Eye Drops
1057740|NCT00673764|O1|Outcome|Systane Ultra|Systane Ultra Lubricant Eye Drops.
1057741|NCT00673764|E2|Reported Event|Optive|Optive Lubricant Eye Drops
1057742|NCT00673764|E1|Reported Event|Systane Ultra|Systane Ultra Lubricant Eye Drops.
1057743|NCT00673738|B1|Baseline|Cetuximab Plus Radiotherapy|Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT)
1057744|NCT00673738|P1|Participant Flow|Cetuximab Plus Radiotherapy|Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT)
1057745|NCT00673738|O1|Outcome|Cetuximab Plus Radiotherapy|Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT). Patients were treated with definitive radiotherapy (70 Gy in 35 fractions, per our currently-existing institutional standard) with concurrent cetuximab followed by 3 cycles of consolidation docetaxel plus cetuximab.
1057746|NCT00673738|O1|Outcome|Cetuximab Plus Radiotherapy|Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT). Patients were treated with definitive radiotherapy (70 Gy in 35 fractions, per our currently-existing institutional standard) with concurrent cetuximab followed by 3 cycles of consolidation docetaxel plus cetuximab.
1057747|NCT00673738|O1|Outcome|Cetuximab Plus Radiotherapy|Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT). Patients were treated with definitive radiotherapy (70 Gy in 35 fractions, per our currently-existing institutional standard) with concurrent cetuximab followed by 3 cycles of consolidation docetaxel plus cetuximab.
1057748|NCT00673738|E1|Reported Event|Cetuximab Plus Radiotherapy|Concurrent Cetuximab plus Conformal Thoracic Radiotherapy (CTRT)
1057749|NCT00673712|B3|Baseline|Total|Total of all reporting groups
1057750|NCT00673712|B2|Baseline|Opioid Based Analgesia|"Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics~Opioid based analgesia: Opioid Analgesic agents delivered by:~PCA on demand mode IV injections PRN IM injections PRN Oral PRN"
1057751|NCT00673712|B1|Baseline|Continuous Sternal Block|"Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system~Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic"
1057752|NCT00673712|P2|Participant Flow|Opioid Based Analgesia|"Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics~Opioid based analgesia: Opioid Analgesic agents delivered by:~PCA on demand mode IV injections PRN IM injections PRN Oral PRN"
1057753|NCT00673712|P1|Participant Flow|Continuous Sternal Block|"Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system~Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic"
1057754|NCT00673712|O2|Outcome|Opioid Based Analgesia|"Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics~Opioid based analgesia: Opioid Analgesic agents delivered by:~PCA on demand mode IV injections PRN IM injections PRN Oral PRN"
1057755|NCT00673712|O1|Outcome|Continuous Sternal Block|"Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system~Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic"
1057756|NCT00673712|O2|Outcome|Opioid Based Analgesia|"Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics~Opioid based analgesia: Opioid Analgesic agents delivered by:~PCA on demand mode IV injections PRN IM injections PRN Oral PRN"
1057757|NCT00673712|O1|Outcome|Continuous Sternal Block|"Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system~Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic"
1057758|NCT00673712|O2|Outcome|Opioid Based Analgesia|"Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics~Opioid based analgesia: Opioid Analgesic agents delivered by:~PCA on demand mode IV injections PRN IM injections PRN Oral PRN"
1057759|NCT00673712|O1|Outcome|Continuous Sternal Block|"Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system~Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic"
1057760|NCT00673712|E2|Reported Event|Opioid Based Analgesia|"Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics~Opioid based analgesia: Opioid Analgesic agents delivered by:~PCA on demand mode IV injections PRN IM injections PRN Oral PRN"
1057761|NCT00673712|E1|Reported Event|Continuous Sternal Block|"Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system~Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic"
1057839|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
1057840|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
1060261|NCT00666965|O4|Outcome|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
1057762|NCT00673673|B1|Baseline|FOLFOX/Bevacizumab Administration|"FOLFOX in combination with bevacizumab~FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours~bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy"
1057763|NCT00673673|P1|Participant Flow|FOLFOX/Bevacizumab Administration|"FOLFOX in combination with bevacizumab~FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours~bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy"
1057764|NCT00673673|O1|Outcome|FOLFOX/Bevacizumab Administration|"FOLFOX in combination with bevacizumab~FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours~bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy"
1057765|NCT00673673|O1|Outcome|FOLFOX/Bevacizumab Administration|"FOLFOX in combination with bevacizumab~FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours~bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy"
1057766|NCT00673673|O1|Outcome|FOLFOX/Bevacizumab Administration|"FOLFOX in combination with bevacizumab~FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours~bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy"
1057767|NCT00673673|E1|Reported Event|FOLFOX/Bevacizumab Administration|"FOLFOX in combination with bevacizumab~FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours~bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy"
1057768|NCT00673660|B1|Baseline|Statins|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
1057769|NCT00673660|P1|Participant Flow|Statins|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
1057770|NCT00673660|O1|Outcome|Statins|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
1057771|NCT00673660|O1|Outcome|Statins|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
1057772|NCT00673660|O2|Outcome|Non-compliant With Statin Treatment|Participants with dyslipidemia who were non-compliant with statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
1057773|NCT00673660|O1|Outcome|Compliant With Statin Treatment|Participants with dyslipidemia who were compliant with statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
1057774|NCT00673660|O1|Outcome|Statins|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
1057775|NCT00673660|E4|Reported Event|Statins Visit 5|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
1057776|NCT00673660|E3|Reported Event|Statins at Visit 4|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
1057777|NCT00673660|E2|Reported Event|Statins at Visit 3|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
1057778|NCT00673660|E1|Reported Event|Statins at Visit 2|Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).
1057779|NCT00673595|B3|Baseline|Total|Total of all reporting groups
1057780|NCT00673595|B2|Baseline|Placebo|Participants on this arm will receive placebo tablets for 15 days.
1057781|NCT00673595|B1|Baseline|Varenicline|Participants on this arm will receive varenicline tablets for 15 days.
1057782|NCT00673595|P2|Participant Flow|Placebo|Participants on this arm will receive placebo tablets for 15 days.
1057783|NCT00673595|P1|Participant Flow|Varenicline|Participants on this arm will receive varenicline tablets for 15 days.
1057784|NCT00673595|O2|Outcome|Placebo|Participants on this arm will receive placebo tablets for 15 days.
1057785|NCT00673595|O1|Outcome|Varenicline|Participants on this arm will receive varenicline tablets for 15 days.
1057786|NCT00673595|O2|Outcome|Placebo|Participants on this arm will receive placebo tablets for 15 days.
1057787|NCT00673595|O1|Outcome|Varenicline|Participants on this arm will receive varenicline tablets for 15 days.
1057788|NCT00673595|E2|Reported Event|Placebo|Participants on this arm will receive placebo tablets for 15 days.
1057789|NCT00673595|E1|Reported Event|Varenicline|Participants on this arm will receive varenicline tablets for 15 days.
1057790|NCT00673465|B1|Baseline|All Treated Participants|All participants received SCH 497079 for 4 weeks, placebo for 4 weeks, and metformin for 4 weeks during one of three parts of the study.
1057791|NCT00673465|P12|Participant Flow|Part 2/Treatment Sequence 6: Metformin → Placebo → SCH 497079|Participants received metformin daily for 4 weeks (Period 1) followed by placebo daily for 4 weeks(Period 2) followed by SCH 497079 daily for 4 weeks (Period 3).
1057792|NCT00673465|P11|Participant Flow|Part 2/Treatment Sequence 5: Placebo → SCH 49709 → Metformin|Participants received placebo daily for 4 weeks (Period 1) followed by SCH 497079 daily for 4 weeks (Period 2) followed by metformin daily for 4 weeks (Period 3).
1057793|NCT00673465|P10|Participant Flow|Part 2/Treatment Sequence 4: SCH 497079 → Metformin → Placebo|Participants received SCH 497079 daily for 4 weeks (Period 1) followed by metformin daily for 4 weeks (Period 2) followed by placebo daily for 4 weeks (Period 3).
1057794|NCT00673465|P9|Participant Flow|Part 2/Treatment Sequence 3: Metformin → SCH 497079 → Placebo|Participants received metformin daily for 4 weeks (Period 1) followed by SCH 497079 daily for 4 weeks (Period 2) followed by placebo daily for 4 weeks (Period 3).
1057795|NCT00673465|P8|Participant Flow|Part 2/Treatment Sequence 2: Placebo → Metformin → SCH 497079|Participants received placebo daily for 4 weeks (Period 1) followed by metformin daily for 4 weeks (Period 2) followed by SCH 497079 daily for 4 weeks (Period 3).
1057796|NCT00673465|P7|Participant Flow|Part 2/Treatment Sequence 1: SCH 497079 → Placebo → Metformin|Participants received SCH 497079 daily for 4 weeks (Period 1) followed by placebo daily for 4 weeks (Period 2) followed by metformin daily for 4 weeks (Period 3).
1057797|NCT00673465|P6|Participant Flow|Part 1/Treatment Sequence 6: Metformin → Placebo → SCH 497079|Participants received metformin daily for 4 weeks (Period 1) followed by placebo daily for 4 weeks (Period 2) followed by SCH 497079 daily for 4 weeks (Period 3).
1057798|NCT00673465|P5|Participant Flow|Part 1/Treatment Sequence 5: Placebo → SCH 49709 → Metformin|Participants received placebo daily for 4 weeks (Period 1) followed by SCH 497079 daily for 4 weeks (Period 2) followed by metformin daily for 4 weeks (Period 3).
1057799|NCT00673465|P4|Participant Flow|Part 1/Treatment Sequence 4: SCH 497079 → Metformin → Placebo|Participants received SCH 497079 daily for 4 weeks (Period 1) followed by metformin daily for 4 weeks (Period 2) followed by placebo daily for 4 weeks (Period 3).
1057800|NCT00673465|P3|Participant Flow|Part 1/Treatment Sequence 3: Metformin → SCH 497079 → Placebo|Participants received metformin daily for 4 weeks (Period 1) followed by SCH 497079 daily for 4 weeks (Period 2)followed by placebo daily for 4 weeks (Period 3).
1057801|NCT00673465|P2|Participant Flow|Part 1/Treatment Sequence 2: Placebo → Metformin → SCH 497079|Participants received placebo daily for 4 weeks (Period 1) followed by metformin daily for 4 weeks (Period 2)followed by SCH 497079 daily for 4 weeks (Period 3).
1057802|NCT00673465|P1|Participant Flow|Part 1/Treatment Sequence 1: SCH 497079 → Placebo → Metformin|Participants received SCH 497079 daily for 4 weeks (Period 1) followed by placebo daily for 4 weeks (Period 2) followed by metformin daily for 4 weeks (Period 3).
1057803|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
1057804|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
1057805|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
1057806|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
1057807|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
1057808|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
1057809|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
1057810|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
1057811|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
1057812|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
1057813|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
1057814|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
1057815|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
1057816|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
1057817|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
1057818|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
1057819|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
1057820|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
1057821|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
1057822|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
1057823|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
1057824|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
1057825|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
1057826|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
1057827|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
1057828|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
1057829|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
1057830|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
1057831|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
1057832|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
1057833|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
1057834|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
1057835|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
1057836|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
1057837|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
1057838|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
1057841|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
1057842|NCT00673465|O3|Outcome|Metformin|Participants received metformin daily for 4 weeks during one period of the study.
1057843|NCT00673465|O2|Outcome|Placebo|Participants received placebo daily for 4 weeks during one period of the study.
1057844|NCT00673465|O1|Outcome|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
1057845|NCT00673465|E3|Reported Event|Metformin|Participants received metformin daily for 4 weeks during one of 3 parts of the study.
1057846|NCT00673465|E2|Reported Event|SCH 497079|Participants received SCH 497079 daily for 4 weeks during one period of the study.
1057847|NCT00673465|E1|Reported Event|Placebo|Participants received placebo daily for 4 weeks during one of 3 parts of the study.
1057848|NCT00673452|B3|Baseline|Total|Total of all reporting groups
1057849|NCT00673452|B2|Baseline|Placebo|oral, daily, 12 weeks
1057850|NCT00673452|B1|Baseline|Duloxetine|60-120 mg, oral, daily, 12 weeks
1057851|NCT00673452|P2|Participant Flow|Placebo|oral, daily, 12 weeks
1057852|NCT00673452|P1|Participant Flow|Duloxetine|60-120 mg, oral, daily, 12 weeks
1057853|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
1057854|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
1057855|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
1057856|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
1057857|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
1057858|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
1057859|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
1057860|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
1057861|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
1057862|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
1057863|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
1057864|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
1057865|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
1057866|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
1057867|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
1057868|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
1057869|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
1057870|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
1057871|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
1057872|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
1057873|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
1057874|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
1057875|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
1057876|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
1057877|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
1057878|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
1057879|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
1057880|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
1057881|NCT00673452|O2|Outcome|Placebo|oral, daily, 12 weeks
1057882|NCT00673452|O1|Outcome|Duloxetine|60-120 mg, oral, daily, 12 weeks
1057883|NCT00673452|E2|Reported Event|Placebo|oral, daily, 12 weeks
1057884|NCT00673452|E1|Reported Event|Duloxetine|60-120 mg, oral, daily, 12 weeks
1057885|NCT00673439|B1|Baseline|Daily Subcutaneous Injection of Fondaparinux (7.5-10 mg)|
1057886|NCT00673439|P1|Participant Flow|Daily Subcutaneous Injection of Fondaparinux (7.5-10 mg)|
1057887|NCT00673439|O1|Outcome|Daily Subcutaneous Injection of Fondaparinux (7.5-10 mg|
1057888|NCT00673439|E1|Reported Event|Daily Subcutaneous Injection of Fondaparinux (7.5-10 mg)|
1057889|NCT00673400|B1|Baseline|Stapled TransAnal Rectal Resection|patients were operated by stapled transanal rectal resection
1057890|NCT00673400|P1|Participant Flow|Stapled TransAnal Rectal Resection|patients were operated by stapled transanal rectal resection
1057891|NCT00673400|O2|Outcome|6 Months After Surgery|outcome measured 6 months after surgery
1057892|NCT00673400|O1|Outcome|Before Surgery|outcome measured within one month before surgery
1057893|NCT00673400|O4|Outcome|6 Months After Surgery|outcome measured 6 months after surgery
1057894|NCT00673400|O3|Outcome|3 Months After Surgery|outcome measured 3 months after surgery
1057895|NCT00673400|O2|Outcome|6 Weeks After Surgery|outcome measured 6 weeks after surgery
1057896|NCT00673400|O1|Outcome|Before Surgery|outcome measured within one month before surgery
1057897|NCT00673400|O4|Outcome|6 Months After Surgery|outcome measured 6 months after surgery
1057898|NCT00673400|O3|Outcome|3 Months After Surgery|outcome measured 3 months after surgery
1057899|NCT00673400|O2|Outcome|6 Weeks After Surgery|outcome measured 6 weeks after surgery
1057900|NCT00673400|O1|Outcome|Before Surgery|outcome measured within one month before surgery
1057901|NCT00673400|O1|Outcome|Stapled TransAnal Rectal Resection|patients were operated by stapled transanal rectal resection
1057902|NCT00673400|O1|Outcome|Stapled TransAnal Rectal Resection|patients were operated by stapled transanal rectal resection
1057903|NCT00673400|O2|Outcome|6 Months After Surgery|outcome measured within one month before surgery
1057904|NCT00673400|O1|Outcome|Before Surgery|outcome measured within one month before surgery
1057905|NCT00673400|E1|Reported Event|Stapled TransAnal Rectal Resection|patients were operated by stapled transanal rectal resection
1057906|NCT00673387|B9|Baseline|Total|Total of all reporting groups
1057907|NCT00673387|B8|Baseline|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1063204|NCT00661479|B5|Baseline|Total|Total of all reporting groups
1058332|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
1057908|NCT00673387|B7|Baseline|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057909|NCT00673387|B6|Baseline|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057910|NCT00673387|B5|Baseline|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
1057911|NCT00673387|B4|Baseline|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
1057912|NCT00673387|B3|Baseline|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
1057913|NCT00673387|B2|Baseline|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057914|NCT00673387|B1|Baseline|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
1057915|NCT00673387|P8|Participant Flow|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057916|NCT00673387|P7|Participant Flow|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057917|NCT00673387|P6|Participant Flow|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057918|NCT00673387|P5|Participant Flow|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
1057919|NCT00673387|P4|Participant Flow|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
1057920|NCT00673387|P3|Participant Flow|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
1057921|NCT00673387|P2|Participant Flow|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057922|NCT00673387|P1|Participant Flow|Placebo|Self administered twice a day (BID) for 28 weeks, subcutaneous (SC) placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
1057923|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057924|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057925|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057926|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
1057927|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
1057928|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
1057929|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057930|NCT00673387|O1|Outcome|Placebo|Self administered twice a day (BID) for 28 weeks, subcutaneous (SC) placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
1057931|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057932|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057933|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1059192|NCT00669916|P2|Participant Flow|Placebo|Placebo was administered intravenously as a single dose.
1057934|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
1057935|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
1057936|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
1057937|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057938|NCT00673387|O1|Outcome|Placebo|Self administered twice a day (BID) for 28 weeks, subcutaneous (SC) placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
1057939|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057940|NCT00673387|O5|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057941|NCT00673387|O4|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057942|NCT00673387|O3|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
1057943|NCT00673387|O2|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
1057944|NCT00673387|O1|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
1057945|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057946|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057947|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057948|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
1057949|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
1057950|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
1057951|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057952|NCT00673387|O1|Outcome|Placebo|Self administered twice a day (BID) for 28 weeks, subcutaneous (SC) placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
1057953|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057954|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057955|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057956|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
1057957|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
1057958|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
1057959|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057960|NCT00673387|O1|Outcome|Placebo|Self administered twice a day (BID) for 28 weeks, subcutaneous (SC) placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
1057961|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057962|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057963|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057964|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
1057965|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
1057966|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
1057967|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057968|NCT00673387|O1|Outcome|Placebo|Self administered twice a day (BID) for 28 weeks, subcutaneous (SC) placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
1057969|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057970|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057971|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057972|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
1057973|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
1057974|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
1057975|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057976|NCT00673387|O1|Outcome|Placebo|Self administered twice a day (BID) for 28 weeks, subcutaneous (SC) placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
1057977|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057978|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057979|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057980|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
1057981|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
1057982|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
1057983|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057984|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
1057985|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057986|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057987|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057988|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
1057989|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
1057990|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
1057991|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057992|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
1057993|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057994|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057995|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1057996|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
1057997|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
1057998|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
1057999|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058000|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
1058001|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058002|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058003|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058004|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
1058005|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
1058006|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
1058007|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058008|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
1058009|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058010|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058011|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058012|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
1058013|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
1058014|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
1058015|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058016|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
1058017|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058018|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058019|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058020|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
1058021|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
1058022|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
1058023|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058024|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
1058025|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058026|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058027|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058028|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
1058029|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
1058030|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
1058031|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058032|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
1058033|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058034|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058035|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058036|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
1058037|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
1058038|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
1058039|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058040|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
1058041|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058042|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058096|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
1058043|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058044|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
1058045|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
1058046|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
1058047|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058048|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
1058049|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058050|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058051|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058052|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
1058053|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
1058054|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
1058055|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058056|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
1058057|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058058|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058059|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058060|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
1058061|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
1058062|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
1058063|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058064|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
1058065|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058066|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058067|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058068|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
1058069|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
1058070|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
1058071|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058072|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
1058073|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058074|NCT00673387|O5|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058075|NCT00673387|O4|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058076|NCT00673387|O3|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
1058077|NCT00673387|O2|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
1058078|NCT00673387|O1|Outcome|Pramlintide 360 mcg + Placebo-M|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058079|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058080|NCT00673387|O5|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058081|NCT00673387|O4|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058082|NCT00673387|O3|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
1058083|NCT00673387|O2|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
1058084|NCT00673387|O1|Outcome|Pramlintide 360 mcg + Placebo-M|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058085|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058086|NCT00673387|O5|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058087|NCT00673387|O4|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058088|NCT00673387|O3|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
1058089|NCT00673387|O2|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
1058090|NCT00673387|O1|Outcome|Pramlintide 360 mcg + Placebo-M|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058091|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058092|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058093|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058094|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
1058095|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
1058097|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058098|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
1058099|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058100|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058101|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058102|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
1058103|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
1058104|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
1058105|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058106|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
1058107|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058108|NCT00673387|O5|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058109|NCT00673387|O4|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058110|NCT00673387|O3|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
1058111|NCT00673387|O2|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
1058112|NCT00673387|O1|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
1058113|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058114|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058115|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058116|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
1058117|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
1058118|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
1058119|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058120|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
1058121|NCT00673387|O8|Outcome|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058122|NCT00673387|O7|Outcome|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058331|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
1063497|NCT00660660|E2|Reported Event|Placebo|Capsule once daily (QD)
1058123|NCT00673387|O6|Outcome|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058124|NCT00673387|O5|Outcome|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg
1058125|NCT00673387|O4|Outcome|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
1058126|NCT00673387|O3|Outcome|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
1058127|NCT00673387|O2|Outcome|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058128|NCT00673387|O1|Outcome|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
1058129|NCT00673387|E8|Reported Event|Pramlintide 360 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 5.0 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058130|NCT00673387|E7|Reported Event|Pramlintide 360 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 2.5 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058131|NCT00673387|E6|Reported Event|Pramlintide 360 mcg + Metreleptin 1.25 mg|Self administered BID for 28 weeks, SC Pramlintide 360 mcg plus SC Metreleptin 1.25 mg. The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058132|NCT00673387|E5|Reported Event|Pramlintide 180 mcg + Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 5.0 mg.
1058133|NCT00673387|E4|Reported Event|Pramlintide 180 mcg + Metreleptin 2.5 mg|Self administered BID for 28 weeks, SC Pramlintide 180 mcg plus SC Metreleptin 2.5 mg.
1058134|NCT00673387|E3|Reported Event|Metreleptin 5.0 mg|Self administered BID for 28 weeks, SC metreleptin 5.0 mg plus SC Placebo matched to pramlintide (Placebo-P).
1058135|NCT00673387|E2|Reported Event|Pramlintide 360 mcg|Self administered BID for 28 weeks, SC 360 mcg pramlintide acetate plus SC Placebo matched to Metreleptin (Placebo-M). The first week of the 28 weeks started with a lower pramlintide dose (180 mcg) in a blinded fashion (using 2 different concentrations of pramlintide so the dose change was not apparent to the participant).
1058136|NCT00673387|E1|Reported Event|Placebo|Self administered BID for 28 weeks, SC placebo matched to pramlintide (Placebo-P) plus SC placebo matched to metreleptin (Placebo-M).
1058137|NCT00673361|B1|Baseline|"Chemo-Switch Regimen"|
1058138|NCT00673361|P1|Participant Flow|"Chemo-Switch Regimen"|
1058139|NCT00673361|O1|Outcome|Terminated Studybefore Accrual Goal|
1058140|NCT00673361|E1|Reported Event|"Chemo-Switch Regimen"|
1058141|NCT00673257|B1|Baseline|Pharmacokinetics of Daunorubicin Chemotherapy Patients|Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration < 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
1058142|NCT00673257|P1|Participant Flow|Pharmacokinetics of Daunorubicin Chemotherapy Patients|Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration < 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
1058143|NCT00673257|O1|Outcome|Pharmacokinetics of Daunorubicin Chemotherapy Patients|Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration < 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
1058185|NCT00673179|B1|Baseline|Outpatient Chemotherapy|Pre-Surgery, Group 1: Doxorubicin intravenous (IV) 90 mg daily, Cisplatin 60 mg/m^2/day for 2 days, Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Surgery; Post-Surgery, Regimen A: Methotrexate 12 gm/m^2, Doxorubicin IV 90 mg, Cisplatin 60 mg/ m^2 twice daily, Leucovorin Rescue or Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen B: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
1058581|NCT00672178|B1|Baseline|SBRT|Stereotactic body radiotherapy concurrent with sorafenib
1058144|NCT00673257|O1|Outcome|Pharmacokinetics of Daunorubicin Chemotherapy Patients|Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration < 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
1058145|NCT00673257|E1|Reported Event|Pharmacokinetics of Daunorubicin Chemotherapy Patients|Patients receiving a chemotherapy regimen including daunorubicin hydrochloride administered as an infusion of any duration < 24 hours on a 1 or a 2 day schedule. Pre-study evaluations no greater than 14 days prior to daunomycin administration. If patients have had significant intercurrent illness or treatment that might affect organ function, laboratory work should be performed at an appropriately closer interval to daunomycin administration. A complete history and physical examination including height, weight and body surface area. Patients should be weighed with only light clothing; shoes must be removed before weight is measured. Patients height should be measured using a stadiometer after removing shoes. Laboratory evaluation: a) CBC with differential and platelet count. b) ALT, AST, bilirubin, creatinine, total protein, albumin, alkaline phosphatase, GGT.
1058146|NCT00673231|B5|Baseline|Total|Total of all reporting groups
1058147|NCT00673231|B4|Baseline|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
1058148|NCT00673231|B3|Baseline|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
1058149|NCT00673231|B2|Baseline|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
1058150|NCT00673231|B1|Baseline|Placebo|Placebo
1058151|NCT00673231|P4|Participant Flow|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
1058152|NCT00673231|P3|Participant Flow|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
1058153|NCT00673231|P2|Participant Flow|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
1058154|NCT00673231|P1|Participant Flow|Placebo|Placebo
1058155|NCT00673231|O4|Outcome|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
1058156|NCT00673231|O3|Outcome|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
1058157|NCT00673231|O2|Outcome|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
1058158|NCT00673231|O1|Outcome|Placebo|Placebo
1058159|NCT00673231|O4|Outcome|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
1058160|NCT00673231|O3|Outcome|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
1058161|NCT00673231|O2|Outcome|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
1058162|NCT00673231|O1|Outcome|Placebo|Placebo
1058163|NCT00673231|O4|Outcome|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
1058164|NCT00673231|O3|Outcome|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
1058165|NCT00673231|O2|Outcome|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
1058166|NCT00673231|O1|Outcome|Placebo|Placebo
1058167|NCT00673231|O4|Outcome|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
1058168|NCT00673231|O3|Outcome|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
1058169|NCT00673231|O2|Outcome|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
1058170|NCT00673231|O1|Outcome|Placebo|Placebo
1058171|NCT00673231|O4|Outcome|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
1058172|NCT00673231|O3|Outcome|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
1058173|NCT00673231|O2|Outcome|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
1058174|NCT00673231|O1|Outcome|Placebo|Placebo
1058175|NCT00673231|O4|Outcome|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
1058176|NCT00673231|O3|Outcome|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
1058177|NCT00673231|O2|Outcome|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
1058178|NCT00673231|O1|Outcome|Placebo|Placebo
1058179|NCT00673231|E4|Reported Event|Dapagliflozin 10mg|Dapagliflozin tablet oral 10 mg total daily dose once daily 24 weeks
1058180|NCT00673231|E3|Reported Event|Dapagliflozin 5mg|Dapagliflozin tablet oral 5 mg total daily dose once daily 24 weeks
1058181|NCT00673231|E2|Reported Event|Dapagliflozin 2.5mg|Dapagliflozin tablet oral 2.5 mg total daily dose once daily 24 weeks
1058182|NCT00673231|E1|Reported Event|Placebo|Placebo
1058183|NCT00673179|B3|Baseline|Total|Total of all reporting groups
1058184|NCT00673179|B2|Baseline|Additional Risk-Adapted Outpatient Chemotherapy|Pre-Surgery, Group 2: Dexrazoxane 900 mg/m^2 intravenous (IV) then Doxorubicin IV 90 mg daily, Cisplatin 120 mg/m^2 (intra-arterial); Surgery; Post-Surgery, all Group 2 assigned to Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen 2: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
1058186|NCT00673179|P2|Participant Flow|Additional Risk-Adapted Outpatient Chemotherapy|Pre-Surgery, Group 2: Dexrazoxane 900 mg/m^2 intravenous (IV) then Doxorubicin IV 90 mg daily, Cisplatin 120 mg/m^2 (intra-arterial); Surgery; Post-Surgery, all Group 2 assigned to Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen 2: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
1058187|NCT00673179|P1|Participant Flow|Outpatient Chemotherapy|Pre-Surgery, Group 1: Doxorubicin intravenous (IV) 90 mg daily, Cisplatin 60 mg/m^2/day for 2 days, Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Surgery; Post-Surgery, Regimen A: Methotrexate 12 gm/m^2, Doxorubicin IV 90 mg, Cisplatin 60 mg/ m^2 twice daily, Leucovorin Rescue or Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen B: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
1058188|NCT00673179|O2|Outcome|Additional Risk-Adapted Outpatient Chemotherapy|Pre-Surgery, Group 2: Dexrazoxane 900 mg/m^2 intravenous (IV) then Doxorubicin IV 90 mg daily, Cisplatin 120 mg/m^2 (intra-arterial); Surgery; Post-Surgery, all Group 2 assigned to Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen 2: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
1058189|NCT00673179|O1|Outcome|Outpatient Chemotherapy|Pre-Surgery, Group 1: Doxorubicin intravenous (IV) 90 mg daily, Cisplatin 60 mg/m^2/day for 2 days, Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Surgery; Post-Surgery, Regimen A: Methotrexate 12 gm/m^2, Doxorubicin IV 90 mg, Cisplatin 60 mg/ m^2 twice daily, Leucovorin Rescue or Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen B: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
1058190|NCT00673179|E2|Reported Event|Additional Risk-Adapted Outpatient Chemotherapy|Pre-Surgery, Group 2: Dexrazoxane 900 mg/m^2 intravenous (IV) then Doxorubicin IV 90 mg daily, Cisplatin 120 mg/m^2 (intra-arterial); Surgery; Post-Surgery, all Group 2 assigned to Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days
1058191|NCT00673179|E1|Reported Event|Outpatient Chemotherapy|Pre-Surgery, Group 1: Doxorubicin intravenous (IV) 90 mg daily, Cisplatin 60 mg/m^2/day for 2 days, Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Surgery; Post-Surgery, Regimen A: Methotrexate 12 gm/m^2, Doxorubicin IV 90 mg, Cisplatin 60 mg/ m^2 twice daily, Leucovorin Rescue or Regimen B: Methotrexate 12 gm/m^2, Leucovorin Rescue 10 mg IV, with 10 mg orally every 6 hours; Ifosfamide 2.8 grams m^2/day and Mesna 2.8 gm/m^2/day continuous IV over 6 days; Lung-Directed Chemotherapy, Regimen B: Gemcitabine, Sargramostim Inhaled aerosol (5 mcg/kg, maximum dose 300 mcg).
1058192|NCT00673153|B1|Baseline|Arm I|"REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .~CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.~MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.~gemtuzumab ozogamicin: Given IV~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
1058193|NCT00673153|P1|Participant Flow|Arm I|"REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .~CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.~MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.~gemtuzumab ozogamicin: Given IV~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
1058194|NCT00673153|O1|Outcome|Arm I|"REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .~CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.~MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.~gemtuzumab ozogamicin: Given IV~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
1058195|NCT00673153|O1|Outcome|Arm I|"REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .~CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.~MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.~gemtuzumab ozogamicin: Given IV~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
1058196|NCT00673153|O1|Outcome|Arm I|"REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .~CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.~MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.~gemtuzumab ozogamicin: Given IV~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
1058197|NCT00673153|O1|Outcome|Arm I|"REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .~CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.~MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.~gemtuzumab ozogamicin: Given IV~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
1058198|NCT00673153|O1|Outcome|Arm I|"REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .~CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.~MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.~gemtuzumab ozogamicin: Given IV~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
1058199|NCT00673153|E1|Reported Event|Arm I|"REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. .~CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8.~MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.~gemtuzumab ozogamicin: Given IV~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
1058200|NCT00673127|B1|Baseline|KHAD|Ketoconazole, Hydrocortisone and Dutasteride
1058201|NCT00673127|P1|Participant Flow|KHAD|KHAD; ketoconazole, hydrocortisone and dutasteride for CRPC
1058202|NCT00673127|O1|Outcome|KHAD|KHAD: ketoconazole, hydrocortisone and dutasteride for CRPC
1058203|NCT00673127|O1|Outcome|KHAD|Ketoconazole, Hydrocortisone and Dutasteride
1058204|NCT00673127|E1|Reported Event|KHAD|Ketoconazole, Hydrocortisone and Dutasteride
1058205|NCT00673114|B1|Baseline|Transplant Recipients|single arm study
1058206|NCT00673114|P1|Participant Flow|Transplant Recipients|Transplant Recipients
1058207|NCT00673114|O1|Outcome|Transplant Recipients|single arm study
1058208|NCT00673114|O1|Outcome|Transplant Recipients|single arm study
1058209|NCT00673114|O1|Outcome|Transplant Recipients|single arm study
1058210|NCT00673114|O1|Outcome|Transplant Recipients|single arm study
1058211|NCT00673114|O1|Outcome|Transplant Recipients|single arm study
1058212|NCT00673114|O1|Outcome|Transplant Recipients|single arm study
1058213|NCT00673114|O1|Outcome|Transplant Recipients|single arm study
1058214|NCT00673114|O1|Outcome|Transplant Recipients|single arm study
1058215|NCT00673114|E1|Reported Event|Transplant Recipients|single arm study
1058216|NCT00673075|B3|Baseline|Total|Total of all reporting groups
1058217|NCT00673075|B2|Baseline|Carvedilol|Encapsulated Carvedilol
1058218|NCT00673075|B1|Baseline|Nebivolol|Encapsulated Nebivolol
1058219|NCT00673075|P2|Participant Flow|Carvedilol|Encapsulated Carvedilol
1058220|NCT00673075|P1|Participant Flow|Nebivolol|Encapsulated Nebivolol
1058221|NCT00673075|O2|Outcome|Carvedilol|Encapsulated Carvedilol
1058222|NCT00673075|O1|Outcome|Nebivolol|Encapsulated Nebivolol
1058223|NCT00673075|O2|Outcome|Carvedilol|Encapsulated Carvedilol
1058224|NCT00673075|O1|Outcome|Nebivolol|Encapsulated Nebivolol
1058225|NCT00673075|O2|Outcome|Carvedilol|Encapsulated Carvedilol
1058226|NCT00673075|O1|Outcome|Nebivolol|Encapsulated Nebivolol
1058227|NCT00673075|O2|Outcome|Carvedilol|Encapsulated Carvedilol
1058228|NCT00673075|O1|Outcome|Nebivolol|Encapsulated Nebivolol
1058229|NCT00673075|E4|Reported Event|Carvedilol Down-Titration|Encapsulated Carvedilol Down-Titration Period
1058230|NCT00673075|E3|Reported Event|Nebivolol Down-Titration|Encapsulated Nebivolol Down-Titration Period
1058231|NCT00673075|E2|Reported Event|Carvedilol Combined Up-Titration and Stable-dose|Encapsulated Carvedilol Combined Up-Titration and Stable-Dose Periods
1058232|NCT00673075|E1|Reported Event|Nebivolol Combined Up-Titration and Stable-dose|Encapsulated Nebivolol Combined Up-Titration and Stable-Dose Periods
1058233|NCT00673049|B3|Baseline|Total|Total of all reporting groups
1058234|NCT00673049|B2|Baseline|Erlotinib (as Randomized)|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food. Intent-to-treat population according to randomization was analyzed.
1058235|NCT00673049|B1|Baseline|Figitumumab + Erlotinib (as Randomized)|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycles. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg at least 1 hour before or 2 hours after the ingestion of food. Intent-to-treat population according to randomization was analyzed.
1058236|NCT00673049|P4|Participant Flow|Erlotinib, Then Figitumumab|Figitumumab 20 mg/kg was given as a single-agent therapy to participants who had disease progression on erlotinib alone. Figitumumab was administered in 3-week cycles as IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter.
1058237|NCT00673049|P3|Participant Flow|Randomized to Figi + Erlo Arm But Treated Only With Erlo|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
1058238|NCT00673049|P2|Participant Flow|Erlotinib (Randomized to and Treated With)|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
1058239|NCT00673049|P1|Participant Flow|Figitumumab + Erlotinib (Randomized to and Treated With)|Figitumumab ( [CP-751,871], figi) was given in combination with erlotinib (erlo) in 3-week cycles. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 milligram (mg) daily at least 1 hour before or 2 hours after the ingestion of food.
1058240|NCT00673049|O2|Outcome|Erlotinib|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
1058241|NCT00673049|O1|Outcome|Figitumumab + Erlotinib|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycles. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
1058242|NCT00673049|O2|Outcome|Erlotinib|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
1058243|NCT00673049|O1|Outcome|Figitumumab + Erlotinib|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycles. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
1058244|NCT00673049|O2|Outcome|Erlotinib|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
1058245|NCT00673049|O1|Outcome|Figitumumab + Erlotinib|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycles. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
1058246|NCT00673049|O1|Outcome|Figitumumab + Erlotinib, and Erlotinib Then Figitumumab|Participants who received figitumumab (20 mg/kg), whether figitumumab was given in combination with erlotinib (150 mg/day) from the beginning or figitumumab was given after disease progression with erlotinib (150 mg/day) alone. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter.
1058247|NCT00673049|O1|Outcome|Figitumumab + Erlotinib, and Erlotinib Then Figitumumab|Participants who received figitumumab (20 mg/kg), whether figitumumab was given in combination with erlotinib (150 mg/day) from the beginning or figitumumab was given after disease progression with erlotinib (150 mg/day) alone. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter.
1058248|NCT00673049|O1|Outcome|Figitumumab + Erlotinib, and Erlotinib Then Figitumumab|Participants who received figitumumab (20 mg/kg), whether figitumumab was given in combination with erlotinib (150 mg/day) from the beginning or figitumumab was given after disease progression with erlotinib (150 mg/day) alone. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter.
1058249|NCT00673049|O1|Outcome|Figitumumab + Erlotinib, and Erlotinib Then Figitumumab|Participants who received figitumumab (20 mg/kg), whether figitumumab was given in combination with erlotinib (150 mg/day) from the beginning or figitumumab was given after disease progression with erlotinib (150 mg/day) alone. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter.
1058250|NCT00673049|O2|Outcome|Erlotinib|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
1058251|NCT00673049|O1|Outcome|Figitumumab + Erlotinib|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycles. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
1058252|NCT00673049|O2|Outcome|Erlotinib|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
1058253|NCT00673049|O1|Outcome|Figitumumab + Erlotinib|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycles. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
1058254|NCT00673049|O2|Outcome|Erlotinib|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
1058255|NCT00673049|O1|Outcome|Figitumumab + Erlotinib|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycles. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
1058256|NCT00673049|E3|Reported Event|Erlotinib, Then Figitumumab|Figitumumab (20 mg/kg) was given as a single agent after participants had disease progression on erlotinib alone. Figitumumab was given in 3-week cycles as IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every 3 weeks (from Day 1) thereafter.
1058257|NCT00673049|E2|Reported Event|Erlotinib|Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
1058258|NCT00673049|E1|Reported Event|Figitumumab + Erlotinib|Figitumumab (20 mg/kg) in combination with erlotinib (150 mg/day) was given in 3-week cycle. Figitumumab was administered as an IV infusion on study Days 1 and 2 in Cycle 1, and on Day 1 every three weeks (from Day 1) thereafter. Erlotinib was taken as 150 mg daily at least 1 hour before or 2 hours after the ingestion of food.
1058259|NCT00672984|B4|Baseline|Total|Total of all reporting groups
1058260|NCT00672984|B3|Baseline|Placebo First|Single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in first intervention period; single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in second intervention period (after washout period); single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in third intervention period (after washout period).
1058261|NCT00672984|B2|Baseline|Moxifloxacin First|Single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in first intervention period; single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in second intervention period (after washout period); single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in third intervention period (after washout period).
1058262|NCT00672984|B1|Baseline|Guanfacine First|Single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in first intervention period; single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in second intervention period (after washout period); single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in third intervention period (after washout period).
1058263|NCT00672984|P3|Participant Flow|Placebo First|Single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in first intervention period; single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in second intervention period (after washout period); single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in third intervention period (after washout period).
1058327|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
1058328|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
1058329|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
1058330|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
1058264|NCT00672984|P2|Participant Flow|Moxifloxacin First|Single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in first intervention period; single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in second intervention period (after washout period); single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in third intervention period (after washout period).
1058265|NCT00672984|P1|Participant Flow|Guanfacine First|Single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in first intervention period; single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in second intervention period (after washout period); single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in third intervention period (after washout period).
1058266|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
1058267|NCT00672984|O1|Outcome|Guanfacine 8 mg|8 mg Immediate-release Guanfacine HCl
1058268|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
1058269|NCT00672984|O1|Outcome|Guanfacine 4 mg|4 mg Immediate-release Guanfacine HCl
1058270|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
1058271|NCT00672984|O1|Outcome|Guanfacine 8 mg|8 mg Immediate-release Guanfacine HCl
1058272|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
1058273|NCT00672984|O1|Outcome|Guanfacine 4 mg|4 mg Immediate-release Guanfacine HCl
1058274|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
1058275|NCT00672984|O1|Outcome|Guanfacine 8 mg|8 mg Immediate-release Guanfacine HCl
1058276|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
1058277|NCT00672984|O1|Outcome|Guanfacine 4 mg|4 mg Immediate-release Guanfacine HCl
1058278|NCT00672984|O4|Outcome|Placebo (Moxifloxacin)|
1058279|NCT00672984|O3|Outcome|Placebo (Guanfacine)|
1058280|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
1058281|NCT00672984|O1|Outcome|Guanfacine 8 mg|8 mg Immediate-release Guanfacine HCl
1058282|NCT00672984|O4|Outcome|Placebo (Moxifloxacin)|
1058283|NCT00672984|O3|Outcome|Placebo (Guanfacine)|
1058284|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
1058285|NCT00672984|O1|Outcome|Guanfacine 4 mg|4 mg Immediate-release Guanfacine HCl
1058286|NCT00672984|O4|Outcome|Placebo (Moxifloxacin)|
1058287|NCT00672984|O3|Outcome|Placebo (Guanfacine)|
1058288|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
1058289|NCT00672984|O1|Outcome|Guanfacine 8 mg|8 mg Immediate-release Guanfacine HCl
1058290|NCT00672984|O4|Outcome|Placebo (Moxifloxacin)|
1058291|NCT00672984|O3|Outcome|Placebo (Guanfacine)|
1058292|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
1058293|NCT00672984|O1|Outcome|Guanfacine 4 mg|4 mg Immediate-release Guanfacine HCl
1058294|NCT00672984|O4|Outcome|Placebo (Moxifloxacin)|
1058295|NCT00672984|O3|Outcome|Placebo (Guanfacine)|
1058296|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
1058297|NCT00672984|O1|Outcome|Guanfacine 8 mg|8 mg Immediate-release Guanfacine HCl
1058298|NCT00672984|O4|Outcome|Placebo (Moxifloxacin)|
1058299|NCT00672984|O3|Outcome|Placebo (Guanfacine)|
1058300|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
1058301|NCT00672984|O1|Outcome|Guanfacine 4 mg|4 mg Immediate-release Guanfacine HCl
1058302|NCT00672984|O4|Outcome|Placebo (Moxifloxacin)|
1058303|NCT00672984|O3|Outcome|Placebo (Guanfacine)|
1058304|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
1058305|NCT00672984|O1|Outcome|Guanfacine 8 mg|8 mg Immediate-release Guanfacine HCl
1058306|NCT00672984|O4|Outcome|Placebo (Moxifloxacin)|
1058307|NCT00672984|O3|Outcome|Placebo (Guanfacine)|
1058308|NCT00672984|O2|Outcome|Moxifloxacin|400 mg Avelox, positive control
1058309|NCT00672984|O1|Outcome|Guanfacine 4 mg|4 mg Immediate-release Guanfacine HCl
1058310|NCT00672984|E3|Reported Event|Placebo|
1058311|NCT00672984|E2|Reported Event|Moxifloxacin|Avelox, positive control
1058312|NCT00672984|E1|Reported Event|Guanfacine|Immediate-release Guanfacine HCl
1058313|NCT00672958|B3|Baseline|Total|Total of all reporting groups
1058314|NCT00672958|B2|Baseline|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
1058315|NCT00672958|B1|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
1058316|NCT00672958|P2|Participant Flow|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
1058317|NCT00672958|P1|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
1058318|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
1058319|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
1058320|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
1058321|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
1058322|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
1058323|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
1058324|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
1058325|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
1058326|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
1058333|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
1058334|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
1058335|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
1058336|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
1058337|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
1058338|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
1058339|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
1058340|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
1058341|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
1058342|NCT00672958|O2|Outcome|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
1058343|NCT00672958|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
1058344|NCT00672958|E2|Reported Event|Vortioxetine|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.
1058345|NCT00672958|E1|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks.
1058346|NCT00672932|B3|Baseline|Total|Total of all reporting groups
1058347|NCT00672932|B2|Baseline|No Augmented Treatment|Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen.
1058348|NCT00672932|B1|Baseline|Raltegravir Group|The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
1058349|NCT00672932|P2|Participant Flow|No Augmented Treatment Then Optional Rollover|Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen. After 12 weeks, subjects in this group have the option to rollover into the raltegravir group for 12 weeks.
1058350|NCT00672932|P1|Participant Flow|Raltegravir Group|The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
1058351|NCT00672932|O2|Outcome|No Augmented Treatment|Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen.
1058352|NCT00672932|O1|Outcome|Raltegravir Group|The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
1058353|NCT00672932|O2|Outcome|No Augmented Treatment|Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen.
1058354|NCT00672932|O1|Outcome|Raltegravir Group|The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
1058355|NCT00672932|E2|Reported Event|No Augmented Treatment|Subjects randomized not to receive augmented treatment will continue in the study with their regular antiretroviral regimen.
1058356|NCT00672932|E1|Reported Event|Raltegravir Group|The raltegravir dosing will be 400mg twice daily by mouth. Subjects will continue all of their regular medications throughout the protocol.
1058357|NCT00672854|B3|Baseline|Total|Total of all reporting groups
1058358|NCT00672854|B2|Baseline|Total Parenteral Nutrition (TPN) Given ClinOleic 20%|"TPN subjects receive ClinOleic 20% (olive oil based)~ClinOleic: TPN with ClinOleic (20%)"
1058359|NCT00672854|B1|Baseline|Total Parenteral Nutrition (TPN) Given Intralipid 20%|"TPN subjects receive Intralipid (soybean-based)~Intralipid: TPN with Intralipid (20%)"
1058360|NCT00672854|P2|Participant Flow|Total Parenteral Nutrition (TPN) Given ClinOleic 20%|"TPN subjects receive ClinOleic 20% (olive oil based)~ClinOleic: TPN with ClinOleic (20%)"
1058361|NCT00672854|P1|Participant Flow|Total Parenteral Nutrition (TPN) Given Intralipid 20%|"TPN subjects receive Intralipid (soybean-based)~Intralipid: TPN with Intralipid (20%)"
1058362|NCT00672854|O2|Outcome|Total Parenteral Nutrition (TPN) Given ClinOleic 20%|"TPN subjects receive ClinOleic 20% (olive oil based)~ClinOleic: TPN with ClinOleic (20%)"
1058363|NCT00672854|O1|Outcome|Total Parenteral Nutrition (TPN) Given Intralipid 20%|"TPN subjects receive Intralipid 20% (soybean-based)~Intralipid: TPN with Intralipid (20%)"
1058364|NCT00672854|E2|Reported Event|Total Parenteral Nutrition (TPN) Given ClinOleic 20%|"TPN subjects receive ClinOleic 20% (olive oil based)~ClinOleic: TPN with ClinOleic (20%)"
1058365|NCT00672854|E1|Reported Event|Total Parenteral Nutrition (TPN) Given Intralipid 20%|"TPN subjects receive Intralipid 20% (soybean-based)~Intralipid: TPN with Intralipid (20%)"
1058366|NCT00672841|B3|Baseline|Total|Total of all reporting groups
1058367|NCT00672841|B2|Baseline|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy initiated in response to a positive 1,3-beta-D glucan test for the presumptive early treatment of invasive candidiasis
1058368|NCT00672841|B1|Baseline|Standard Care, Empiric Treatment|Standard care group. Empiric antifungal therapy initiated by physician preference for the treatment of suspected invasive candidiasis.
1058369|NCT00672841|P2|Participant Flow|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy (i.e., intravenous anidulafungin 200mg on day one, then 100mg daily x 14 days) initiated in response to a positive 1,3-beta-D glucan test for the presumptive early treatment of invasive candidiasis
1058370|NCT00672841|P1|Participant Flow|Standard Care, Empiric Treatment|Standard care group. Empiric antifungal therapy initiated by physician preference for the treatment of suspected invasive candidiasis.
1058371|NCT00672841|O2|Outcome|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy initiated in response to a positive 1,3-beta-D glucan test for the presumptive early treatment of invasive candidiasis
1058372|NCT00672841|O1|Outcome|Standard Care, Empiric Treatment|Standard care group. Empiric antifungal therapy initiated by physician preference for the treatment of suspected invasive candidiasis.
1058373|NCT00672841|O2|Outcome|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy initiated in response to a positive 1,3-beta-D glucan (BDG) test for the presumptive early treatment of invasive candidiasis
1060259|NCT00666965|O2|Outcome|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
1058374|NCT00672841|O1|Outcome|Standard Care, Empiric Treatment|Standard care group. Empiric antifungal therapy initiated by physician preference for the treatment of suspected invasive candidiasis.
1058375|NCT00672841|O2|Outcome|Standard Care, Empiric Treatment|Standard care group. Empiric antifungal therapy initiated by physician preference for the treatment of suspected invasive candidiasis.
1058376|NCT00672841|O1|Outcome|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy initiated in response to a positive 1,3-beta-D glucan test for the presumptive early treatment of invasive candidiasis
1058377|NCT00672841|O2|Outcome|Standard Care, Empiric Treatment|Standard care group. Empiric antifungal therapy initiated by physician preference for the treatment of suspected invasive candidiasis.
1058378|NCT00672841|O1|Outcome|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy initiated in response to a positive 1,3-beta-D glucan test for the presumptive early treatment of invasive candidiasis
1058379|NCT00672841|E2|Reported Event|Active Surveillance, Preemptive Therapy|Active surveillance group. Preemptive therapy initiated in response to a positive 1,3-beta-D glucan test for the presumptive early treatment of invasive candidiasis
1058380|NCT00672841|E1|Reported Event|Standard Care, Empiric Treatment|Standard care group. Empiric antifungal therapy initiated by physician preference for the treatment of suspected invasive candidiasis.
1058381|NCT00672646|B4|Baseline|Total|Total of all reporting groups
1058382|NCT00672646|B3|Baseline|Placebo|AZD1386 Placebo oral solution
1058383|NCT00672646|B2|Baseline|Naproxen|Naproxen 500 mg capsule
1058384|NCT00672646|B1|Baseline|AZD1386|AZD1386 95 mg oral solution
1058385|NCT00672646|P3|Participant Flow|Placebo|AZD1386 Placebo oral solution
1058386|NCT00672646|P2|Participant Flow|Naproxen|Naproxen 500 mg capsule
1058387|NCT00672646|P1|Participant Flow|AZD1386|AZD1386 95 mg oral solution
1058388|NCT00672646|O3|Outcome|Placebo|AZD1386 Placebo oral solution
1058389|NCT00672646|O2|Outcome|Naproxen|Naproxen 500 mg capsule
1058390|NCT00672646|O1|Outcome|AZD1386|AZD1386 95 mg oral solution
1058391|NCT00672646|O3|Outcome|Placebo|AZD1386 Placebo oral solution
1058392|NCT00672646|O2|Outcome|Naproxen|Naproxen 500 mg capsule
1058393|NCT00672646|O1|Outcome|AZD1386|AZD1386 95 mg oral solution
1058394|NCT00672646|O3|Outcome|Placebo|AZD1386 Placebo oral solution
1058395|NCT00672646|O2|Outcome|Naproxen|Naproxen 500 mg capsule
1058396|NCT00672646|O1|Outcome|AZD1386|AZD1386 95 mg oral solution
1058397|NCT00672646|O3|Outcome|Placebo|AZD1386 Placebo oral solution
1058398|NCT00672646|O2|Outcome|Naproxen|Naproxen 500 mg capsule
1058399|NCT00672646|O1|Outcome|AZD1386|AZD1386 95 mg oral solution
1058400|NCT00672646|O3|Outcome|Placebo|AZD1386 Placebo oral solution
1058401|NCT00672646|O2|Outcome|Naproxen|Naproxen 500 mg capsule
1058402|NCT00672646|O1|Outcome|AZD1386|AZD1386 95 mg oral solution
1058403|NCT00672646|O3|Outcome|Placebo|AZD1386 Placebo oral solution
1058404|NCT00672646|O2|Outcome|Naproxen|Naproxen 500 mg capsule
1058405|NCT00672646|O1|Outcome|AZD1386|AZD1386 95 mg oral solution
1058406|NCT00672646|E3|Reported Event|Placebo|AZD1386 Placebo oral solution
1058407|NCT00672646|E2|Reported Event|Naproxen|Naproxen 500 mg capsule
1058408|NCT00672646|E1|Reported Event|AZD1386|AZD1386 95 mg oral solution
1058409|NCT00672633|B3|Baseline|Total|Total of all reporting groups
1058410|NCT00672633|B2|Baseline|Placebo|Corn oil placebo
1058411|NCT00672633|B1|Baseline|Lovaza|Treatment Arm
1058412|NCT00672633|P2|Participant Flow|Placebo|Corn oil placebo: 4 pills/day orally for 6 months
1058413|NCT00672633|P1|Participant Flow|Lovaza|Treatment Arm: 4 grams/day orally for 6 months
1058414|NCT00672633|O2|Outcome|Placebo|Corn oil placebo
1058415|NCT00672633|O1|Outcome|Lovaza|Treatment Arm
1058416|NCT00672633|O2|Outcome|Placebo|Corn oil placebo
1058417|NCT00672633|O1|Outcome|Lovaza|Treatment Arm
1058418|NCT00672633|O2|Outcome|Placebo|Corn oil placebo
1058419|NCT00672633|O1|Outcome|Lovaza|Treatment Arm
1058420|NCT00672633|E2|Reported Event|Placebo|Corn oil placebo
1058421|NCT00672633|E1|Reported Event|Lovaza|Treatment Arm
1058422|NCT00672620|B5|Baseline|Total|Total of all reporting groups
1058423|NCT00672620|B4|Baseline|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
1058424|NCT00672620|B3|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
1058425|NCT00672620|B2|Baseline|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
1058426|NCT00672620|B1|Baseline|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1058427|NCT00672620|P4|Participant Flow|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period
1058428|NCT00672620|P3|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
1058429|NCT00672620|P2|Participant Flow|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
1058430|NCT00672620|P1|Participant Flow|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1058431|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
1058432|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
1058582|NCT00672178|P1|Participant Flow|SBRT|Stereotactic body radiotherapy concurrent with sorafenib
1058433|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
1058434|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1058435|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
1058436|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
1058437|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
1058438|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1058439|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
1058440|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
1058441|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
1058442|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1058443|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
1058444|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
1058445|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
1058446|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1058447|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
1058448|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
1058449|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
1058450|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1058451|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
1058452|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
1058453|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
1058454|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1058455|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
1058456|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
1058457|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
1058458|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1058459|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
1058460|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
1058461|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
1058462|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1058463|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
1058464|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
1058465|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
1058466|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1058467|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
1058468|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
1058583|NCT00672178|O1|Outcome|SBRT|Stereotactic body radiotherapy concurrent with sorafenib
1058469|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
1058470|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1058471|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
1058472|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
1058473|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
1058474|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1058475|NCT00672620|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
1058476|NCT00672620|O3|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
1058477|NCT00672620|O2|Outcome|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
1058478|NCT00672620|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1058479|NCT00672620|E4|Reported Event|Duloxetine 60 mg|Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsule, orally, once daily for 1 week after the treatment period.
1058480|NCT00672620|E3|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
1058481|NCT00672620|E2|Reported Event|Vortioxetine 2.5 mg|Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
1058482|NCT00672620|E1|Reported Event|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
1058483|NCT00672594|B1|Baseline|Treatment|"Only study arm; treatment arm.~Sunitinib Malate : 50mg daily x 4 weeks"
1058484|NCT00672594|P1|Participant Flow|50mg Sunitinib Malate|Sunitinib Malate 50mg capsule by mouth once daily for 4 weeks
1058485|NCT00672594|O1|Outcome|50 mg Sunitinib Malate|"Only study arm; treatment arm.~Sunitinib Malate : 50mg daily x 4 weeks"
1058486|NCT00672594|O1|Outcome|50 mg Sunitinib Malate|"Only study arm; treatment arm.~Sunitinib Malate : 50mg daily x 4 weeks"
1058487|NCT00672594|O1|Outcome|50 mg Sunitinib Malate|"Only study arm; treatment arm.~Sunitinib Malate : 50mg daily x 4 weeks"
1058488|NCT00672594|O1|Outcome|50 mg Sunitinib Malate|"Only study arm; treatment arm.~Sunitinib Malate : 50mg daily x 4 weeks"
1058489|NCT00672594|O1|Outcome|50 mg Sunitinib Malate|"Only study arm; treatment arm.~Sunitinib Malate : 50mg daily x 4 weeks"
1058490|NCT00672594|O1|Outcome|50 mg Sunitinib Malate|"Only study arm; treatment arm.~Sunitinib Malate : 50mg daily x 4 weeks"
1058491|NCT00672594|O1|Outcome|50 mg Sunitinib Malate|"Only study arm; treatment arm.~Sunitinib Malate : 50mg daily x 4 weeks"
1058492|NCT00672594|O1|Outcome|50 mg Sunitinib Malate|"Only study arm; treatment arm.~Sunitinib Malate : 50mg daily x 4 weeks"
1058493|NCT00672594|E1|Reported Event|50 mg Sunitinib Malate|"Only study arm; treatment arm.~Sunitinib Malate : 50mg daily x 4 weeks"
1058494|NCT00672555|B1|Baseline|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
1058495|NCT00672555|P1|Participant Flow|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
1058496|NCT00672555|O1|Outcome|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
1058497|NCT00672555|O1|Outcome|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
1058498|NCT00672555|O1|Outcome|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
1058499|NCT00672555|O1|Outcome|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
1058500|NCT00672555|O1|Outcome|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
1058501|NCT00672555|O1|Outcome|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
1058502|NCT00672555|E1|Reported Event|Pilonidal Sinus Treated With Limberg Flap|All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.
1058503|NCT00672490|B3|Baseline|Total|Total of all reporting groups
1058504|NCT00672490|B2|Baseline|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
1058505|NCT00672490|B1|Baseline|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
1058506|NCT00672490|P2|Participant Flow|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
1058507|NCT00672490|P1|Participant Flow|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
1064278|NCT00658684|O1|Outcome|Total|All subjects
1058508|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
1058509|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
1058510|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
1058511|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
1058512|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
1058513|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
1058514|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
1058515|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
1058516|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
1058517|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
1058518|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
1058519|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
1058520|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
1058521|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
1058522|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
1058523|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
1058524|NCT00672490|O2|Outcome|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
1058525|NCT00672490|O1|Outcome|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
1058526|NCT00672490|E2|Reported Event|Quetiapine Fumarate Used as Adjunct Therapy|Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
1058527|NCT00672490|E1|Reported Event|Quetiapine Fumarate Used as Mono-Therapy|Quetiapine Fumarate 600 to 800 mg/day
1058528|NCT00672438|B3|Baseline|Total|Total of all reporting groups
1058529|NCT00672438|B2|Baseline|Saline Placebo Infusion Prior to Alfentanil Infusion|50% of participants were randomized to receive a saline placebo infusion prior to an infusion of alfentanil. All other procedures were identical in both groups.
1058530|NCT00672438|B1|Baseline|Alfentanil Infusion Prior to Saline Placebo Infusion|50% of participants were randomized to receive an infusion of alfentanil prior to a saline placebo infusion. All other procedures were identical in both groups.
1058531|NCT00672438|P2|Participant Flow|Saline Placebo Infusion Prior to Alfentanil Infusion|50% of participants were randomized to receive a saline placebo infusion prior to an infusion of alfentanil via a computer-controlled infusion pump targeting a steady-state plasma concentration of 100ng/ml. All other procedures were identical in both groups.
1058532|NCT00672438|P1|Participant Flow|Alfentanil Infusion Prior to Saline Placebo Infusion|50% of participants were randomized to receive an infusion of alfentanil via a computer-controlled infusion targeting steady-state plasma concentration of 100ng/ml prior to a saline placebo infusion. All other procedures were identical in both groups.
1058533|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
1058534|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
1058535|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
1058536|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
1058537|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
1058538|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
1058539|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
1058540|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
1058541|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
1058542|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
1058543|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
1058544|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
1058545|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
1058546|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
1058547|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
1058548|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
1058549|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
1058550|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
1058551|NCT00672438|O2|Outcome|Saline Infusion|All participants received a saline infusion. All participants received NS at an infusion rate identical to the alfentanil rate.
1058552|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
1058584|NCT00672178|E1|Reported Event|SBRT|Stereotactic body radiotherapy concurrent with sorafenib
1058553|NCT00672438|O2|Outcome|Saline Infusion|All participants received a saline infusion. All participants received NS at an infusion rate identical to the alfentanil rate.
1058554|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
1058555|NCT00672438|O2|Outcome|Saline Infusion|All participants received a saline infusion. All participants received NS at an infusion rate identical to the alfentanil rate.
1058556|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
1058557|NCT00672438|O2|Outcome|Saline Infusion|All participants received a saline infusion. All participants received NS at an infusion rate identical to the alfentanil rate.
1058558|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
1058559|NCT00672438|O2|Outcome|Saline Infusion|All participants received NS at an infusion rate identical to the alfentanil rate.
1058560|NCT00672438|O1|Outcome|Alfentanil Infusion|A controlled intravenous infusion was run at a rate to target an alfentanil plasma concentration of 100ng/ml
1058561|NCT00672438|E1|Reported Event|Alfentanil|Intravenous infusion of Alfentanil
1058562|NCT00672256|B1|Baseline|Smokers|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
1058563|NCT00672256|P1|Participant Flow|Smokers|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
1058564|NCT00672256|O1|Outcome|Smokers|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
1058565|NCT00672256|O1|Outcome|Smokers|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
1058566|NCT00672256|O1|Outcome|Smokers|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
1058567|NCT00672256|O1|Outcome|Smokers|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
1058568|NCT00672256|E1|Reported Event|Smokers|Men and women ages 18-50 who smoke at least 10 cigarettes per day of a brand delivery at least 0.5 mg of nicotine for at least 2 years.
1058569|NCT00672243|B1|Baseline|Erlotinib + Sirolimus|Erlotinib & sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of erlotinib and 5mg of sirolimus for patients not on concurrent CY3PA-inducing anti-epileptics (EIAEDS) and 400 mg of erlotinib and 10 mg of sirolimus for patients on concurrent EIAEDS.
1058570|NCT00672243|P1|Participant Flow|Erlotinib + Sirolimus|Erlotinib & sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of erlotinib and 5mg of sirolimus for patients not on concurrent Cytochrome P450, family 3, subfamily A (CY3PA)-inducing anti-epileptics (EIAEDS) and 400 mg of erlotinib and 10 mg of sirolimus for patients on concurrent EIAEDS.
1058571|NCT00672243|O1|Outcome|Tarceva and Rapamycin|
1058572|NCT00672243|O1|Outcome|Erlotinib + Sirolimus|Erlotinib & sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of erlotinib and 5mg of sirolimus for patients not on concurrent CY3PA-inducing anti-epileptics (EIAEDS) and 400 mg of erlotinib and 10 mg of sirolimus for patients on concurrent EIAEDS.
1058573|NCT00672243|O1|Outcome|Erlotinib + Sirolimus|Erlotinib & sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of erlotinib and 5mg of sirolimus for patients not on concurrent CY3PA-inducing anti-epileptics (EIAEDS) and 400 mg of erlotinib and 10 mg of sirolimus for patients on concurrent EIAEDS.
1058574|NCT00672243|O1|Outcome|Erlotinib + Sirolimus|Erlotinib & sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of erlotinib and 5mg of sirolimus for patients not on concurrent CY3PA-inducing anti-epileptics (EIAEDS) and 400 mg of erlotinib and 10 mg of sirolimus for patients on concurrent EIAEDS.
1058575|NCT00672243|O1|Outcome|Erlotinib + Sirolimus|Erlotinib & sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of erlotinib and 5mg of sirolimus for patients not on concurrent CY3PA-inducing anti-epileptics (EIAEDS) and 400 mg of erlotinib and 10 mg of sirolimus for patients on concurrent EIAEDS.
1058576|NCT00672243|E1|Reported Event|Tarceva and Rapamycin|
1058577|NCT00672204|B1|Baseline|Allogeneic Islets of Langerhans|"Allogeneic islets of Langerhans~anti-thymocyte globulin : 2.0 mg/kg on days -2, and -1 IV~Raptiva : Treatment Day -1 pretransplant to Treatment Day 90 after tx.: 1.0 mg/kg/wk SQ; Treatment Day 91 to Treatment Day 365: 0.5 mg/kg/wk SQ;~Allogeneic islets of Langerhans transplant : Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. Each infusion to contain at least 5,000 islet equivalents/kg body weight.~Sirolimus : Initial dose 0.1 mg/kg PO on day -2, followed by 0.05 mg/kg daily, whole blood 24-hour trough adjusted to target 3-15 ng/ml as tolerated"
1058578|NCT00672204|P1|Participant Flow|Allogeneic Islets of Langerhans|"Allogeneic islets of Langerhans~anti-thymocyte globulin : 2.0 mg/kg on days -2, and -1 IV~Raptiva : Treatment Day -1 pretransplant to Treatment Day 90 after tx.: 1.0 mg/kg/wk SQ; Treatment Day 91 to Treatment Day 365: 0.5 mg/kg/wk SQ;~Allogeneic islets of Langerhans transplant : Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. Each infusion to contain at least 5,000 islet equivalents/kg body weight.~Sirolimus : Initial dose 0.1 mg/kg PO on day -2, followed by 0.05 mg/kg daily, whole blood 24-hour trough adjusted to target 3-15 ng/ml as tolerated"
1058579|NCT00672204|O1|Outcome|Allogeneic Islets of Langerhans|"Allogeneic islets of Langerhans~anti-thymocyte globulin : 2.0 mg/kg on days -2, and -1 IV~Raptiva : Treatment Day -1 pretransplant to Treatment Day 90 after tx.: 1.0 mg/kg/wk SQ; Treatment Day 91 to Treatment Day 365: 0.5 mg/kg/wk SQ;~Allogeneic islets of Langerhans transplant : Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. Each infusion to contain at least 5,000 islet equivalents/kg body weight.~Sirolimus : Initial dose 0.1 mg/kg PO on day -2, followed by 0.05 mg/kg daily, whole blood 24-hour trough adjusted to target 3-15 ng/ml as tolerated"
1058580|NCT00672204|E1|Reported Event|Allogeneic Islets of Langerhans|"Allogeneic islets of Langerhans~anti-thymocyte globulin : 2.0 mg/kg on days -2, and -1 IV~Raptiva : Treatment Day -1 pretransplant to Treatment Day 90 after tx.: 1.0 mg/kg/wk SQ; Treatment Day 91 to Treatment Day 365: 0.5 mg/kg/wk SQ;~Allogeneic islets of Langerhans transplant : Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. Each infusion to contain at least 5,000 islet equivalents/kg body weight.~Sirolimus : Initial dose 0.1 mg/kg PO on day -2, followed by 0.05 mg/kg daily, whole blood 24-hour trough adjusted to target 3-15 ng/ml as tolerated"
1058586|NCT00672100|B3|Baseline|Ropivacaine 20 mL|Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
1058587|NCT00672100|B2|Baseline|Ropivacaine 10 mL|Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
1058588|NCT00672100|B1|Baseline|Ropivacaine 5 mL|Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
1058589|NCT00672100|P3|Participant Flow|Ropivacaine 20 mL|Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
1058590|NCT00672100|P2|Participant Flow|Ropivacaine 10 mL|Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
1058591|NCT00672100|P1|Participant Flow|Ropivacaine 5 mL|Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
1058592|NCT00672100|O1|Outcome|All Study Participants|All study participants who received Interscalene block (ISB) using 5-20 mL of local anesthetic.
1058593|NCT00672100|O3|Outcome|Ropivacaine 20 mL|Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
1058594|NCT00672100|O2|Outcome|Ropivacaine 10 mL|Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
1058595|NCT00672100|O1|Outcome|Ropivacaine 5 mL|Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
1058596|NCT00672100|O3|Outcome|Ropivacaine 20 mL|
1058597|NCT00672100|O2|Outcome|Ropivacaine 10 mL|
1058598|NCT00672100|O1|Outcome|Ropivacaine 5 mL|
1058599|NCT00672100|O3|Outcome|Ropivacaine 20 mL|Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
1058600|NCT00672100|O2|Outcome|Ropivacaine 10 mL|Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
1058601|NCT00672100|O1|Outcome|Ropivacaine 5 mL|Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
1058602|NCT00672100|E3|Reported Event|Ropivacaine 20 mL|Initial Bolus 0f 20 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
1058603|NCT00672100|E2|Reported Event|Ropivacaine 10 mL|Initial Bolus 0f 10 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
1058604|NCT00672100|E1|Reported Event|Ropivacaine 5 mL|Initial Bolus 0f 5 ml Ropivacaine 0.75% administered as interscalene peripheral nerve block prior to surgical procedure performed with ultrasound guidance followed by a continuous infusion of Ropivacaine 0.2% using the Stryker Pain Pump II with the following setting: 3 ml bolus/demand, 4ml/hr continuous infusion with a 20 min lock-out.
1058605|NCT00671970|B3|Baseline|Total|Total of all reporting groups
1058606|NCT00671970|B2|Baseline|WHO Grade IV|WHO Grade IV Malignant Glioma
1058607|NCT00671970|B1|Baseline|Who Grade III|Who Grade III Malignant Glioma
1058608|NCT00671970|P2|Participant Flow|WHO Grade IV|"WHO Grade IV Malignant Glioma~Bevacizumab administered intravenously at dose 10 mg/kg every 2 wks. Erlotinib administered orally, continuously once daily in fasting state for each 42-day cycle. It will be 200 mg/day for pts not on cytochrome P450 3A4 (CYP3A4)-enzyme inducing anti-epileptic drugs & 500 mg/day for pts on EIAEDs."
1058609|NCT00671970|P1|Participant Flow|WHO Grade III|"WHO Grade III Malignant Glioma~Bevacizumab administered intravenously at dose 10 mg/kg every 2 wks. Erlotinib administered orally, continuously once daily in fasting state for each 42-day cycle. It will be 200 mg/day for pts not on cytochrome P450 3A4 (CYP3A4)-enzyme inducing anti-epileptic drugs & 500 mg/day for pts on EIAEDs."
1058610|NCT00671970|O2|Outcome|Patients Who Survived Less Than 1 Year|Patients who survived less than 1 year
1058611|NCT00671970|O1|Outcome|Patients Who Survived At Least 1 Year|Patients who survived at least 1 year
1058612|NCT00671970|O2|Outcome|Patients Who Survived Less Than 1 Year|Patients who survived less than 1 year
1058613|NCT00671970|O1|Outcome|Patients Who Survived At Least 1 Year|Patients who survived at least 1 year
1058614|NCT00671970|O2|Outcome|Negative Expression|pMAPK negative expression
1058615|NCT00671970|O1|Outcome|Positive Expression|pMAPK positive expression
1058616|NCT00671970|O2|Outcome|Negative Expression|pAKT negative expression
1058617|NCT00671970|O1|Outcome|Positive Expression|pAKT positive expression
1058618|NCT00671970|O2|Outcome|Loss|PTEN Loss
1058619|NCT00671970|O1|Outcome|Intact|PTEN Intact
1058620|NCT00671970|O2|Outcome|Negative Expression|EGFR vIII negative expression
1058621|NCT00671970|O1|Outcome|Positive Expression|EGFR vIII positive expression
1058622|NCT00671970|O2|Outcome|Negative Expression|EGFR negative expression
1058623|NCT00671970|O1|Outcome|Positive Expression|EGFR positive expression
1058624|NCT00671970|O1|Outcome|WHO Grade IV|WHO Grade IV Malignant Glioma
1058625|NCT00671970|O1|Outcome|WHO Grade IV|WHO Grade IV Malignant Glioma
1058626|NCT00671970|O2|Outcome|WHO Grade IV|WHO Grade IV Malignant Glioma
1058627|NCT00671970|O1|Outcome|Who Grade III|Who Grade III Malignant Glioma
1058628|NCT00671970|O2|Outcome|WHO Grade IV|WHO Grade IV Malignant Glioma
1058629|NCT00671970|O1|Outcome|Who Grade III|Who Grade III Malignant Glioma
1058630|NCT00671970|E1|Reported Event|All Patients|All Patients
1058631|NCT00671931|B6|Baseline|Total|Total of all reporting groups
1058632|NCT00671931|B5|Baseline|Intermediate Dexmedetomidine/Intermediate Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
1058633|NCT00671931|B4|Baseline|High Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
1058634|NCT00671931|B3|Baseline|Low Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
1058635|NCT00671931|B2|Baseline|High Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
1058636|NCT00671931|B1|Baseline|Low Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
1058637|NCT00671931|P5|Participant Flow|Intermediate Dexmedetomidine/Intermediate Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
1058678|NCT00671853|O2|Outcome|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
1058679|NCT00671853|O1|Outcome|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
1058680|NCT00671853|O2|Outcome|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
1058681|NCT00671853|O1|Outcome|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
1058638|NCT00671931|P4|Participant Flow|High Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
1058639|NCT00671931|P3|Participant Flow|Low Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
1058640|NCT00671931|P2|Participant Flow|High Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
1058641|NCT00671931|P1|Participant Flow|Low Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
1058642|NCT00671931|O5|Outcome|Intermediate Dexmedetomidine/Intermediate Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
1058643|NCT00671931|O4|Outcome|High Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
1058644|NCT00671931|O3|Outcome|Low Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
1058645|NCT00671931|O2|Outcome|High Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
1058646|NCT00671931|O1|Outcome|Low Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
1058647|NCT00671931|E5|Reported Event|Intermediate Dexmedetomidine/Intermediate Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
1058648|NCT00671931|E4|Reported Event|High Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
1058649|NCT00671931|E3|Reported Event|Low Dexmedetomidine/High Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
1058650|NCT00671931|E2|Reported Event|High Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
1058651|NCT00671931|E1|Reported Event|Low Dexmedetomidine/Low Propofol|"Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.~TABLE 2: dexmedetomidine and propofol dose schedule.~Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75"
1058652|NCT00671918|B1|Baseline|Lymphoseek|Enrolled patients who were administered any injection of Lymphoseek.
1058653|NCT00671918|P1|Participant Flow|Lymphoseek, Lymphatic Mapping, Injection|Melanoma and breast cancer patients to receive a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 1.0 mCi Tc-99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
1058654|NCT00671918|O1|Outcome|Reverse Intent-To-Treat|Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 1.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
1058655|NCT00671918|O1|Outcome|Intent-To-Treat|Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 1.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
1058656|NCT00671918|E1|Reported Event|Lymphoseek|Enrolled patients who were administered any injection of Lymphoseek.
1058657|NCT00671879|B4|Baseline|Total|Total of all reporting groups
1058658|NCT00671879|B3|Baseline|Placebo|Placebo treatment arm
1058659|NCT00671879|B2|Baseline|Carisoprodol SR 500mg|Carisoprodol SR 500 mg twice daily
1058660|NCT00671879|B1|Baseline|Carisprodol SR 700 mg|Carisoprodol 700 mg twice daily
1058661|NCT00671879|P3|Participant Flow|Placebo|Placebo treatment arm
1058662|NCT00671879|P2|Participant Flow|Carisoprodol SR 500mg|Carisoprodol SR 500 mg twice daily
1058663|NCT00671879|P1|Participant Flow|Carisprodol SR 700 mg|Carisoprodol 700 mg twice daily
1058664|NCT00671879|O3|Outcome|Placebo|Placebo treatment arm
1058665|NCT00671879|O2|Outcome|Carisoprodol SR 500mg|Carisoprodol SR 500 mg twice daily
1058666|NCT00671879|O1|Outcome|Carisprodol SR 700 mg|Carisoprodol 700 mg twice daily
1058667|NCT00671879|O3|Outcome|Placebo|Placebo treatment arm
1058668|NCT00671879|O2|Outcome|Carisoprodol SR 500mg|Carisoprodol SR 500 mg twice daily
1058669|NCT00671879|O1|Outcome|Carisprodol SR 700 mg|Carisoprodol SR 700 mg twice daily
1058670|NCT00671879|E3|Reported Event|Placebo|Placebo treatment arm
1058671|NCT00671879|E2|Reported Event|Carisoprodol SR 500mg|Carisoprodol SR 500 mg twice daily
1058672|NCT00671879|E1|Reported Event|Carisprodol SR 700 mg|Carisoprodol 700 mg twice daily
1058673|NCT00671853|B3|Baseline|Total|Total of all reporting groups
1058674|NCT00671853|B2|Baseline|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
1058675|NCT00671853|B1|Baseline|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
1058676|NCT00671853|P2|Participant Flow|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
1058677|NCT00671853|P1|Participant Flow|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
1058682|NCT00671853|O2|Outcome|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
1058683|NCT00671853|O1|Outcome|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
1058684|NCT00671853|O2|Outcome|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
1058685|NCT00671853|O1|Outcome|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
1058686|NCT00671853|O2|Outcome|Placebo for Quetiapine XR|
1058687|NCT00671853|O1|Outcome|Quetiapine XR|
1058688|NCT00671853|O2|Outcome|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
1058689|NCT00671853|O1|Outcome|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
1058690|NCT00671853|E2|Reported Event|Placebo for Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
1058691|NCT00671853|E1|Reported Event|Quetiapine XR|Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
1058692|NCT00671788|B1|Baseline|Dasatinib|Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
1058693|NCT00671788|P1|Participant Flow|Dasatinib|Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
1058694|NCT00671788|O1|Outcome|Dasatinib|Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
1058695|NCT00671788|O1|Outcome|Dasatinib|Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
1058696|NCT00671788|O1|Outcome|Dasatinib|Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
1058697|NCT00671788|O1|Outcome|Dasatinib|Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
1058698|NCT00671788|E1|Reported Event|Dasatinib|Dasatinib 100 mg orally once daily every day continuously (one cycle = 28 days) until disease progression or adverse effects prohibit further therapy. If the patient does not experience any side effects when taking this dose of dasatinib for the first cycle of treatment, the dosage will be increased before starting the second cycle of treatment to 140 mg of dasatinib orally, 70 mg in the morning and 70 mg in the evening
1058699|NCT00671749|B1|Baseline|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
1058700|NCT00671749|P1|Participant Flow|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
1058701|NCT00671749|O1|Outcome|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
1058702|NCT00671749|O1|Outcome|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
1058703|NCT00671749|O1|Outcome|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
1058704|NCT00671749|O1|Outcome|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
1058705|NCT00671749|O1|Outcome|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
1058706|NCT00671749|O1|Outcome|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
1058707|NCT00671749|O1|Outcome|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
1058708|NCT00671749|E1|Reported Event|Combination Therapy|Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening.
1058709|NCT00671671|B3|Baseline|Total|Total of all reporting groups
1058710|NCT00671671|B2|Baseline|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
1058711|NCT00671671|B1|Baseline|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
1058712|NCT00671671|P2|Participant Flow|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
1058713|NCT00671671|P1|Participant Flow|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
1058714|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
1058715|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
1058716|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
1058717|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
1058718|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
1058719|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
1058720|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
1058721|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
1058722|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
1058723|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
1058724|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
1058725|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
1058726|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
1058727|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
1058728|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
1065451|NCT00654498|E2|Reported Event|Placebo|
1058729|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
1058730|NCT00671671|O2|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
1058731|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
1058732|NCT00671671|O1|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
1058733|NCT00671671|O1|Outcome|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
1058734|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
1058735|NCT00671671|O1|Outcome|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
1058736|NCT00671671|E2|Reported Event|PF-00868554 700 mg (Cohort B)|Participants who did not receive any prior treatment for HCV with an IFN-alpha regimen (with or without RBV) or who discontinued from an IFN-alpha regimen (with or without RBV) after less than or equal to (<=) 2 weeks of treatment due to tolerability issues or other reasons, received PF-00868554 700 mg tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 3 evening dose in a fed state.
1058737|NCT00671671|E1|Reported Event|PF-00868554 450 mg (Cohort A)|Participants who had a history of unsuccessful treatment for hepatitis C virus (HCV) with an interferon-alpha (IFN-alpha) regimen (with or without ribavirin [RBV]) due to lack of response or relapse, received PF-00868554 450 milligram (mg) tablet orally twice daily, every 12 hours from Day 1 morning dose to Day 10 morning dose in a fasted state.
1058738|NCT00671606|B1|Baseline|Intraoperative Lymphatic Mapping|Intraoperative sentinel lymph node identification (lymphatic mapping)
1058739|NCT00671606|P1|Participant Flow|Intraoperative Lymphatic Mapping|Intraoperative sentinel lymph node identification (lymphatic mapping)
1058740|NCT00671606|O1|Outcome|Intraoperative Lymphatic Mapping|Intraoperative sentinel lymph node identification (lymphatic mapping)
1058741|NCT00671606|E1|Reported Event|Intraoperative Lymphatic Mapping|Intraoperative sentinel lymph node identification (lymphatic mapping)
1058742|NCT00671554|B1|Baseline|Melaxin|Melaxin vaccine in conjunction with Bacillus Calmette-Guerin (BCG)
1058743|NCT00671554|P1|Participant Flow|Melaxin|Melaxin vaccine in conjunction with Bacillus Calmette-Guerin (BCG). Four 1 ml doses of 250,000 dendritomas Subcutaneous (SQ) at 4 week intervals along with a separate SQ injection containing 1 million Colony Forming Units (CFU) of BCG. The dose of BCG will be decreased by 50% in subsequent dosing if there is injection site ulceration.
1058744|NCT00671554|O1|Outcome|Melaxin and BCG|"Four 1 ml doses of 250,000 dendritomas SQ at 4 week intervals along with a separate SQ injection containing 1 million Colony Forming Units (CFU) of BCG. The dose of BCG will be decreased by 50% in subsequent dosing if there is injection site ulceration~Melaxin (autologous dendritoma vaccine) and BCG: Four 1 ml doses of 250,000 dendritomas SQ at 4 week intervals along with a separate SQ injection containing 1 million CFU of BCG. The dose of BCG will be decreased by 50% in subsequent dosing if there is injection site ulceration."
1058745|NCT00671554|O1|Outcome|Melaxin|Melaxin vaccine in conjunction with Bacillus Calmette-Guerin (BCG)
1058746|NCT00671554|E1|Reported Event|Melaxin|Melaxin vaccine in conjunction with Bacillus Calmette-Guerin (BCG)
1058747|NCT00671528|B4|Baseline|Total|Total of all reporting groups
1058748|NCT00671528|B3|Baseline|Betamethasone Diproprionate Cream|Betamethasone diproprionate 0.05% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
1058749|NCT00671528|B2|Baseline|Betamethasone Diproprionate and Gentamicin Sulfate Cream|Combination of Betamethasone diproprionate 0.05% cream and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
1058750|NCT00671528|B1|Baseline|Quadriderme® Cream|Combination of Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area 2 times a day (BID), morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
1058751|NCT00671528|P3|Participant Flow|Betamethasone Diproprionate Cream|Betamethasone diproprionate 0.05% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
1058810|NCT00671177|O1|Outcome|Water Immersion Colonoscopy|Water immersion colonoscopy: instillation of 300cc of water in the rectum
1058752|NCT00671528|P2|Participant Flow|Betamethasone Diproprionate and Gentamicin Sulfate Cream|Combination of Betamethasone diproprionate 0.05% cream and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
1058753|NCT00671528|P1|Participant Flow|Quadriderme® Cream|Combination of Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area 2 times a day (BID), morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
1058754|NCT00671528|O3|Outcome|Betamethasone Diproprionate Cream|Betamethasone diproprionate 0.05% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
1058755|NCT00671528|O2|Outcome|Betamethasone Diproprionate and Gentamicin Sulfate Cream|Combination of Betamethasone diproprionate 0.05% cream and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
1058756|NCT00671528|O1|Outcome|Quadriderme® Cream|Combination of Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area 2 times a day (BID), morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
1058757|NCT00671528|O3|Outcome|Betamethasone Diproprionate Cream|Betamethasone diproprionate 0.05% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
1058758|NCT00671528|O2|Outcome|Betamethasone Diproprionate and Gentamicin Sulfate Cream|Combination of Betamethasone diproprionate 0.05% cream and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
1058759|NCT00671528|O1|Outcome|Quadriderme® Cream|Combination of Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area 2 times a day (BID), morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
1058760|NCT00671528|E3|Reported Event|Betamethasone Diproprionate Cream|Betamethasone diproprionate 0.05% cream applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
1058761|NCT00671528|E2|Reported Event|Betamethasone Diproprionate and Gentamicin Sulfate Cream|Combination of Betamethasone diproprionate 0.05% cream and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area BID, morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
1058762|NCT00671528|E1|Reported Event|Quadriderme® Cream|Combination of Betamethasone diproprionate 0.05%, clotrimazole 1%, and gentamicin sulfate 0.1% applied in a thin layer that covers the affected and surrounding area 2 times a day (BID), morning and night for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days.
1058763|NCT00671515|B1|Baseline|Pioglitazone|An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
1058764|NCT00671515|P1|Participant Flow|Pioglitazone|An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
1058765|NCT00671515|O1|Outcome|Pioglitazone|An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
1058766|NCT00671515|O1|Outcome|Pioglitazone|An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
1058767|NCT00671515|E1|Reported Event|Pioglitazone|An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
1058768|NCT00671502|B4|Baseline|Total|Total of all reporting groups
1058769|NCT00671502|B3|Baseline|Placebo Tablet|tablet placebo no experimental formulation
1058770|NCT00671502|B2|Baseline|Carisoprodol 500mg Tablet|tablet experimental formulation
1058771|NCT00671502|B1|Baseline|Carisoprodol 700mg|tablet experimental formulation
1058772|NCT00671502|P3|Participant Flow|Placebo Tablet|tablet placebo no experimental formulation
1058773|NCT00671502|P2|Participant Flow|Carisoprodol 500mg Tablet|tablet experimental formulation
1058774|NCT00671502|P1|Participant Flow|Carisoprodol 700mg|tablet experimental formulation
1058775|NCT00671502|O3|Outcome|Placebo Tablets|placebo tablets treatment arm
1058776|NCT00671502|O2|Outcome|Carisoprodol 700mg Tablets|carisoprodol 700mg tablets treatment arm
1058777|NCT00671502|O1|Outcome|Carisoprodol 500mg Tablets|carisoprodol 500mg tablets treatment arm
1058778|NCT00671502|E3|Reported Event|Placebo Tablet|tablet placebo no experimental formulation
1058779|NCT00671502|E2|Reported Event|Carisoprodol 500mg Tablet|tablet experimental formulation
1058780|NCT00671502|E1|Reported Event|Carisoprodol 700mg|tablet experimental formulation
1058781|NCT00671437|B1|Baseline|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
1058811|NCT00671177|E2|Reported Event|Standard Air Colonoscopy|Standard air colonoscopy: air instillation in colon for visualization
1058812|NCT00671177|E1|Reported Event|Water Immersion Colonoscopy|Water immersion colonoscopy: instillation of 300cc of water in the rectum
1058813|NCT00671060|B3|Baseline|Total|Total of all reporting groups
1059331|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
1058782|NCT00671437|P1|Participant Flow|Arm 1 (Cetuximab)|"Whole body Fluorodeoxyglucose (FDG)- Positron Emission Tomography (PET)/Computed Tomography (CT) scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 intravenously (IV) over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
1058783|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
1058784|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body Fluorodeoxyglucose (FDG)- Positron Emission Tomography (PET)/Computed Tomography (CT) scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 intravenously (IV) over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
1058785|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body Fluorodeoxyglucose (FDG)- Positron Emission Tomography (PET)/Computed Tomography (CT) scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 intravenously (IV) over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
1058786|NCT00671437|O3|Outcome|Progressive Disease by Both CT and PET/CT|
1058787|NCT00671437|O2|Outcome|Disease Control by CT and Progressive Disease by PET/CT|
1058788|NCT00671437|O1|Outcome|Disease Control by CT and PET/CT|
1058789|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
1058790|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
1058791|NCT00671437|O4|Outcome|Total (Overall PET Response)|
1058792|NCT00671437|O3|Outcome|Progressive Metabolic Disease (Overall PET Response)|
1058793|NCT00671437|O2|Outcome|Stable Metabolic Disease (Overall PET Response)|
1058794|NCT00671437|O1|Outcome|Partial Metabolic Response (Overall PET Response)|
1058795|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
1058796|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
1058797|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
1058798|NCT00671437|O1|Outcome|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
1058799|NCT00671437|E1|Reported Event|Arm 1 (Cetuximab)|"Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)~Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.~Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)~Cetuximab 250 mg/m2 IV over 1 hour on Day 57~Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease"
1058800|NCT00671177|B3|Baseline|Total|Total of all reporting groups
1058801|NCT00671177|B2|Baseline|Standard Air Colonoscopy|Standard air colonoscopy: air instillation in colon for visualization
1058802|NCT00671177|B1|Baseline|Water Immersion Colonoscopy|Water immersion colonoscopy: instillation of 300cc of water in the rectum
1058803|NCT00671177|P2|Participant Flow|Standard Air Colonoscopy|"Standard Air Colonoscopy~standard air colonoscopy: air instillation in colon for visualization"
1058804|NCT00671177|P1|Participant Flow|Water Immersion Colonoscopy|"Water Immersion Colonoscopy~water immersion colonoscopy: instillation of 300cc of water in the rectum"
1058805|NCT00671177|O2|Outcome|Standard Air Colonoscopy|Standard air colonoscopy: air instillation in colon for visualization
1058806|NCT00671177|O1|Outcome|Water Immersion Colonoscopy|Water immersion colonoscopy: instillation of 300cc of water in the rectum
1058807|NCT00671177|O2|Outcome|Standard Air Colonoscopy|Standard air colonoscopy: air instillation in colon for visualization
1058808|NCT00671177|O1|Outcome|Water Immersion Colonoscopy|Water immersion colonoscopy: instillation of 300cc of water in the rectum
1058809|NCT00671177|O2|Outcome|Standard Air Colonoscopy|Standard air colonoscopy: air instillation in colon for visualization
1059332|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
1058814|NCT00671060|B2|Baseline|100 Mcg|Women in Group 1 will be administered two tablets (a 100 mcg misoprostol tablet and a placebo tablet made to resemble a 100 mcg misoprostol tablet), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
1058815|NCT00671060|B1|Baseline|200 Mcg|Women in Group 1 will be administered two tablets (2 100 mcg misoprostol tablets), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
1058816|NCT00671060|P2|Participant Flow|100 Mcg|Women in Group 1 will be administered two tablets (a 100 mcg misoprostol tablet and a placebo tablet made to resemble a 100 mcg misoprostol tablet), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
1058817|NCT00671060|P1|Participant Flow|200 Mcg|Women in Group 1 will be administered two tablets (2 100 mcg misoprostol tablets), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
1058818|NCT00671060|O2|Outcome|100 Mcg|Women in Group 1 will be administered two tablets (a 100 mcg misoprostol tablet and a placebo tablet made to resemble a 100 mcg misoprostol tablet), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
1058819|NCT00671060|O1|Outcome|200 Mcg|Women in Group 1 will be administered two tablets (2 100 mcg misoprostol tablets), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
1058820|NCT00671060|E2|Reported Event|100 Mcg|Women in Group 1 will be administered two tablets (a 100 mcg misoprostol tablet and a placebo tablet made to resemble a 100 mcg misoprostol tablet), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
1058821|NCT00671060|E1|Reported Event|200 Mcg|Women in Group 1 will be administered two tablets (2 100 mcg misoprostol tablets), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.
1058822|NCT00670982|B3|Baseline|Total|Total of all reporting groups
1058823|NCT00670982|B2|Baseline|Second Line Treatment|Patients with 1 prior line for metastatic breast cancer will receive bevacizumab intravenously every two weeks, vinorelbine intravenously once per week, and trastuzumab intravenously once per week.
1058824|NCT00670982|B1|Baseline|First Line Treatment|Patients with no prior therapy for metastatic breast cancer will receive bevacizumab intravenously every 2 weeks and vinorelbine intravenously once per week, and trastuzumab intravenously once per week
1058825|NCT00670982|P2|Participant Flow|Second Line Treatment|Patients with 1 prior line for metastatic breast cancer will receive bevacizumab(10mg/kg) intravenously every two weeks, vinorelbine (25mg/m2) intravenously once per week, and trastuzumab(4 mg/kg) intravenously once per week.
1058826|NCT00670982|P1|Participant Flow|First Line Treatment|Patients with no prior therapy for metastatic breast cancer will receive bevacizumab(10mg/kg) intravenously every 2 weeks and vinorelbine(25mg/m2) intravenously once per week, and trastuzumab (4 mg/kg) intravenously once per week
1058827|NCT00670982|O2|Outcome|Second Line Treatment|Patients with 1 prior line for metastatic breast cancer will receive bevacizumab intravenously every two weeks, vinorelbine intravenously once per week, and trastuzumab intravenously once per week.
1058828|NCT00670982|O1|Outcome|First Line Treatment|Patients with no prior therapy for metastatic breast cancer will receive bevacizumab intravenously every 2 weeks and vinorelbine intravenously once per week, and trastuzumab intravenously once per week
1058829|NCT00670982|O2|Outcome|Second Line Treatment|Patients with 1 prior line for metastatic breast cancer will receive bevacizumab intravenously every two weeks, vinorelbine intravenously once per week, and trastuzumab intravenously once per week.
1058830|NCT00670982|O1|Outcome|First Line Treatment|Patients with no prior therapy for metastatic breast cancer will receive bevacizumab intravenously every 2 weeks and vinorelbine intravenously once per week, and trastuzumab intravenously once per week
1058831|NCT00670982|O2|Outcome|Second Line Treatment|Patients with 1 prior line for metastatic breast cancer will receive bevacizumab intravenously every two weeks, vinorelbine intravenously once per week, and trastuzumab intravenously once per week.
1058832|NCT00670982|O1|Outcome|First Line Treatment|Patients with no prior therapy for metastatic breast cancer will receive bevacizumab intravenously every 2 weeks and vinorelbine intravenously once per week, and trastuzumab intravenously once per week
1058833|NCT00670982|E1|Reported Event|All Study Participants|All participants received the same study treatment, so cumulative adverse events are reported here.
1058834|NCT00670956|B1|Baseline|Active Study Group|"STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart~Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart"
1058835|NCT00670956|P1|Participant Flow|Active Study Group|"STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart~Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart"
1058836|NCT00670956|O1|Outcome|Active Study Group|"STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart~Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart"
1058837|NCT00670956|O1|Outcome|Active Study Group|"STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart~Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart"
1058838|NCT00670956|O1|Outcome|Active Study Group|"STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart~Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart"
1058839|NCT00670956|E1|Reported Event|Active Study Group|"STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart~Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart"
1058840|NCT00670930|B3|Baseline|Total|Total of all reporting groups
1058841|NCT00670930|B2|Baseline|Placebo|Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
1058842|NCT00670930|B1|Baseline|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
1058843|NCT00670930|P2|Participant Flow|Placebo|Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
1058844|NCT00670930|P1|Participant Flow|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
1058845|NCT00670930|O2|Outcome|Placebo|Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
1058846|NCT00670930|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
1058847|NCT00670930|O2|Outcome|Placebo|Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
1058848|NCT00670930|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
1058849|NCT00670930|O2|Outcome|Placebo|Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
1058850|NCT00670930|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
1058866|NCT00670800|O2|Outcome|PCOS Affected Women Post-Metformin (After 4 Months)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
1059652|NCT00668265|B1|Baseline|Quetiapine|Subjects on MMTP receiving quetiapine
1058851|NCT00670930|O2|Outcome|Placebo|Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
1058852|NCT00670930|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
1058853|NCT00670930|O2|Outcome|Placebo|Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The number of injections and injection volume was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables. Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
1058854|NCT00670930|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection. The dose administered was individualized for each patient based on the patient’s body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables. Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
1058855|NCT00670930|E2|Reported Event|Placebo|Placebo
1058856|NCT00670930|E1|Reported Event|Omalizumab|Omalizumab
1058857|NCT00670800|B3|Baseline|Total|Total of all reporting groups
1058858|NCT00670800|B2|Baseline|Normal Controls|Normal controls are matched for age and education and screened for insulin resistance. Controls will have HOMA2 IR of 80%S or greater, normal hormone levels, regular menstrual cycles, and lack hirsutism and acne. Exclusion criteria: Left handedness, acute medical illness, uncorrected thyroid disease, diabetes, neurological disease, current psychiatric illness, claustrophobia, contraindications to MRI (including pacemakers, pumps, surgical clips or metallic surgical devices), smoking within the last 6 months, use of hormones or insulin sensitizing mediation within the last 2 months, pregnancy within the last 6 months, current or past history of substance abuse, use of corticosteroids, cardiac or pulmonary insufficiency, active liver disease and transaminases elevations >2.5 X normal values, renal insufficiency (plasma creatinine level ≥1.4 mg/dl), use of centrally acting medications, allergy to any opioid medication, 300 lbs maximum weight limit (which is the max
1058859|NCT00670800|B1|Baseline|PCOS Affected Women - Metformin|Right handed women who don’t smoke and who drink very little will be considered eligible. Women with the following conditions (exclusion criteria) may not participate: left handedness, acute medical illness, uncorrected thyroid disease, diabetes, neurological disease, current psychiatric illness, smoking within the last 6 months, use of hormones within the last 2 months, pregnancy within the last 6 months, current or past history of substance abuse, use of corticosteroids (such as cortisol and prednisone), history of lactic acidosis (condition caused by the buildup of lactic acid in the body), heart, lung and kidney problems, liver disease, use of intravenous dyes, current cimetidine (Tagamet) use, use of medications that affect the brain (for example, codeine, anti-depressants, anti-psychotics).
1058860|NCT00670800|P2|Participant Flow|Women Controls Without PCOS|"Control group is comprised of subjects without PCOS. These women have normal menstrual cycles and no evidence of insulin resistance (fasting HOMA2 IR of 80%S or more).~Exclusion criteria: left handedness, acute medical illness, uncorrected thyroid disease, diabetes, neurological disease, current psychiatric illness, smoking within the last 6 months, use of hormones within the last 2 months, pregnancy within the last 6 months, current or past history of substance abuse, use of corticosteroids (such as cortisol and prednisone), history of lactic acidosis (condition caused by the buildup of lactic acid in the body), heart, lung and kidney problems, liver disease, use of intravenous dyes, current cimetidine (Tagamet) use, use of medications that affect the brain (for example, codeine, anti-depressants, anti-psychotics)."
1058861|NCT00670800|P1|Participant Flow|Women Affected With PCOS - Metformin|The Polycystic Ovary Syndrome (PCOS) affected group is comprised of subjects with insulin resistant PCOS, defined as having irregular menstrual cycles and hyperandrogenism with other causes ruled out. Insulin resistance will be identified as fasting homeostasis model assessment insulin resistance (HOMA2-IR) of 60%S or less.
1058862|NCT00670800|O3|Outcome|Normal Controls|Normal controls will have HOMA2 IR of 80%S or greater, normal hormone levels, regular menstrual cycles (range 24 - 34 days), and lack hirsutism and acne. Control subjects are matched for age and education with the PCOS affected women. Control data is measured once (at baseline time frame) for the entire study.
1058863|NCT00670800|O2|Outcome|PCOS Affected Women Post-Metformin (After 4 Months)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
1058864|NCT00670800|O1|Outcome|PCOS Affected Women Pre-Metformin (Baseline)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
1058865|NCT00670800|O3|Outcome|Normal Controls|Normal controls will have HOMA2 IR of 80%S or greater, normal hormone levels, regular menstrual cycles (range 24 - 34 days), and lack hirsutism and acne. Control subjects are matched for age and education with the PCOS affected women. Control data is measured once (at baseline time frame) for the entire study.
1065452|NCT00654498|E1|Reported Event|Pramipexole|
1058867|NCT00670800|O1|Outcome|PCOS Affected Women Pre-Metformin (Baseline)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
1058868|NCT00670800|O3|Outcome|Normal Control Women|Normal controls will have HOMA2 IR of 80%S or greater, normal hormone levels, regular menstrual cycles (range 24 - 34 days), and lack hirsutism and acne. Control subjects are matched for age and education with the PCOS affected women. Control data is measured once (at baseline time frame) for the entire study.
1058869|NCT00670800|O2|Outcome|PCOS Affected Women Post-Metformin (After 4 Months)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
1058870|NCT00670800|O1|Outcome|PCOS Affected Women Pre-Metformin (Baseline)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
1058871|NCT00670800|O3|Outcome|Normal Controls|Normal controls will have HOMA2 IR of 80%S or greater, normal hormone levels, regular menstrual cycles (range 24 - 34 days), and lack hirsutism and acne. Control subjects are matched for age and education with the PCOS affected women. Control data is measured once (at baseline time frame) for the entire study.
1058872|NCT00670800|O2|Outcome|PCOS Affected Women Post-Metformin (After 4 Months)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
1058873|NCT00670800|O1|Outcome|PCOS Affected Women Pre-Metformin (Baseline)|PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
1058874|NCT00670800|E2|Reported Event|PCOS Affected Women on Metformin|Women with PCOS and insulin resistance
1058875|NCT00670800|E1|Reported Event|Normal Controls|Women without PCOS
1058876|NCT00670748|B5|Baseline|Total|Total of all reporting groups
1058877|NCT00670748|B4|Baseline|#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa|Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
1058878|NCT00670748|B3|Baseline|#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC|"Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide & fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) & high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.~Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.~ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL."
1058879|NCT00670748|B2|Baseline|#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
1058880|NCT00670748|B1|Baseline|#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
1058916|NCT00670540|O1|Outcome|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
1058917|NCT00670540|O1|Outcome|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
1065453|NCT00654420|B5|Baseline|Total|Total of all reporting groups
1058881|NCT00670748|P4|Participant Flow|#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa|Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
1058882|NCT00670748|P3|Participant Flow|#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC|"Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide & fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) & high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.~Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.~ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL."
1058883|NCT00670748|P2|Participant Flow|#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
1058884|NCT00670748|P1|Participant Flow|#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
1058885|NCT00670748|O4|Outcome|#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa|Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
1058886|NCT00670748|O3|Outcome|#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC|"Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide & fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) & high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.~Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.~ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL."
1058887|NCT00670748|O2|Outcome|#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
1058918|NCT00670540|O1|Outcome|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
1058919|NCT00670540|O1|Outcome|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
1058920|NCT00670540|O1|Outcome|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
1058921|NCT00670540|E1|Reported Event|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
1058922|NCT00670462|B3|Baseline|Total|Total of all reporting groups
1058888|NCT00670748|O1|Outcome|#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
1058889|NCT00670748|O4|Outcome|#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa|Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
1058890|NCT00670748|O3|Outcome|#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC|"Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide & fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) & high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.~Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.~ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL."
1058891|NCT00670748|O2|Outcome|#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
1058892|NCT00670748|O1|Outcome|#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
1058893|NCT00670748|O4|Outcome|#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa|Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
1058894|NCT00670748|O3|Outcome|#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC|"Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide & fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) & high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.~Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.~ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL."
1058985|NCT00670306|P1|Participant Flow|Cetrorelix 78 mg|Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
1058986|NCT00670306|O1|Outcome|Cetrorelix 78 mg|Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
1058987|NCT00670306|E1|Reported Event|Cetrorelix 78 mg|Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
1059105|NCT00669942|B12|Baseline|Part 1 - Healthy Volunteers - Placebo|Placebo to AIN457A was administered intravenously as a single dose.
1058895|NCT00670748|O2|Outcome|#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
1058896|NCT00670748|O1|Outcome|#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
1058897|NCT00670748|E4|Reported Event|#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa|Anti-NY ESO-1 T-cell receptor PBL; Pts will receive non-myeloablative lymphodepleting prep regimen cyclophosphamide and fludarabine followed by anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg IV (based on total body wt)over 15 min. every 8 hours (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses). Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr. Fludarabine 25 mg/m2/day IVPB daily over 30 min. for 5 days. ALVAC NY ESO-1 vaccine:Approx. 2 hrs prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50) (with a range of approx.10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL.
1058898|NCT00670748|E3|Reported Event|#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC|"Pts will receive non-myeloablative lymphodepleting prep regimen:cyclophosphamide & fludarabine followed by the anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) & high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Pt Care Unit over 20-30 min. Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body wt)over 15 min. every 8 hrs (+/-1 hr) beginning within 24 hrs of cell infusion and continuing for up to 5 days(max. of 15 doses).Cyclophosphamide 60 mg/kg/dayX2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/dayX2 days over 1 hr.~Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 min. for 5 days.~ALVAC NY ESO-1 vaccine:Approx. 2hrs prior to cell infusion, pts will receive 0.5 mL containing a target dose of 10e7 cell culture infectious dose 50 (CCID50)(with a range of approx. 10e6.4 to 10e7.9 / mL) of the ESO-1 ALVAC virus S.C. in each extremity (total of 4 x 10e7 CCID50/2 mL."
1058899|NCT00670748|E2|Reported Event|#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
1058900|NCT00670748|E1|Reported Event|#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC|"Biological/Vaccine: Anti-NY ESO-1 T-cell receptor PBL Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T-cell receptor (TCR) peripheral blood lymphocytes (PBL) and high dose aldesleukin. On day 0,cells (1x10e8 to 1x10e11)will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Drug: aldesleukin Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days(maximum of 15 doses) Drug: Cyclophosphamide Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Drug: fludarabine phosphate Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days."
1058901|NCT00670709|B3|Baseline|Total|Total of all reporting groups
1058902|NCT00670709|B2|Baseline|Healthy Controls|Healthy control subjects
1058903|NCT00670709|B1|Baseline|Huntington Disease|Subjects with mild or moderate Huntington's Disease
1058904|NCT00670709|P2|Participant Flow|Healthy Controls|Healthy control subjects
1058905|NCT00670709|P1|Participant Flow|Huntington Disease|Subjects with mild or moderate Huntington's Disease
1058906|NCT00670709|O2|Outcome|Healthy Controls|Healthy control subjects
1058907|NCT00670709|O1|Outcome|Huntington Disease|Subjects with mild or moderate Huntington's Disease
1058908|NCT00670709|O2|Outcome|Healthy Controls|Healthy control subjects
1058909|NCT00670709|O1|Outcome|Huntington Disease|Subjects with mild or moderate Huntington's Disease
1058910|NCT00670709|E2|Reported Event|Healthy Controls|Healthy control subjects
1058911|NCT00670709|E1|Reported Event|Huntington Disease|Subjects with mild or moderate Huntington's Disease
1058912|NCT00670540|B1|Baseline|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
1058913|NCT00670540|P1|Participant Flow|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
1058914|NCT00670540|O1|Outcome|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
1058915|NCT00670540|O1|Outcome|OPTIMEV|patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
1058923|NCT00670462|B2|Baseline|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
1058924|NCT00670462|B1|Baseline|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
1058925|NCT00670462|P2|Participant Flow|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
1058926|NCT00670462|P1|Participant Flow|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
1058927|NCT00670462|O2|Outcome|Men SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
1058928|NCT00670462|O1|Outcome|Women SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
1058929|NCT00670462|O2|Outcome|Men SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
1058930|NCT00670462|O1|Outcome|Women SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
1058931|NCT00670462|O2|Outcome|Men SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
1058988|NCT00670267|B1|Baseline|Open Label|nadolol: Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.
1058989|NCT00670267|P1|Participant Flow|Open Label Treatment With Oral Nadolol|Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated.
1058990|NCT00670267|O1|Outcome|Open Label Treatment With Oral Nadolol|
1058991|NCT00670267|O1|Outcome|Open Label Treatment With Oral Nadolol|
1058992|NCT00670267|O1|Outcome|Open Label Treatment With Oral Nadolol|
1058932|NCT00670462|O1|Outcome|Women SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
1058933|NCT00670462|O2|Outcome|Men SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
1058934|NCT00670462|O1|Outcome|Women SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
1058935|NCT00670462|O2|Outcome|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
1058936|NCT00670462|O1|Outcome|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
1058937|NCT00670462|O2|Outcome|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
1058938|NCT00670462|O1|Outcome|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
1058939|NCT00670462|O2|Outcome|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
1058940|NCT00670462|O1|Outcome|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
1058941|NCT00670462|O2|Outcome|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
1059191|NCT00669916|B1|Baseline|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
1058942|NCT00670462|O1|Outcome|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
1058943|NCT00670462|O2|Outcome|Men SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
1058944|NCT00670462|O1|Outcome|Women SBT and MTT|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors."
1058945|NCT00670462|O2|Outcome|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
1058946|NCT00670462|O1|Outcome|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
1058947|NCT00670462|O2|Outcome|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
1058948|NCT00670462|O1|Outcome|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
1058949|NCT00670462|O2|Outcome|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
1058950|NCT00670462|O1|Outcome|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
1058951|NCT00670462|E2|Reported Event|Maintenance-Tailored Treatment (MTT)|"Maintenance-Tailored Treatment (MTT) for weight loss treats diet and exercise strategy embellishments as separate interventions with discrete and independent status. MTT differs from SBT in its emphasis on skills for long-term weight control, namely, the strategy of initiating varied weight-control strategies as a response to the demands of changing environmental challenges and to sustain effective cues and reinforcements needed to motivate weight-loss behaviors.~weight loss intervention: MTT has the same number of treatment contacts, but the contacts are distributed in distinct 8-week segments, each of which have a unique topic and unique behavioral assignments. B"
1058993|NCT00670267|O1|Outcome|Open Label Treatment With Oral Nadolol|Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated.
1058952|NCT00670462|E1|Reported Event|Standard Behavioral Treatment (SBT)|"Standard Behavioral Treatment (SBT) for weight loss introduces a core set of instructions on diet and exercise at the beginning of the intervention and then embellishes these instructions with suggested refinements of behavioral choices over time (e.g., different menus and amounts or types of physical activity).~weight loss intervention: SBT is state-of-the-art behavioral weight loss treatment, comprised of 6 months of weekly treatment meetings followed by 6 months of biweekly meetings and 6 months of monthly meetings. Topical coverage and behavioral assignments include typical combination of energy balance information and self-control skills training."
1058953|NCT00670449|B5|Baseline|Total|Total of all reporting groups
1058954|NCT00670449|B4|Baseline|Placebo-fingolimod 1.25 mg|Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
1058955|NCT00670449|B3|Baseline|Placebo-fingolimod 0.5 mg|Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
1058956|NCT00670449|B2|Baseline|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
1058957|NCT00670449|B1|Baseline|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
1058958|NCT00670449|P4|Participant Flow|Placebo-fingolimod 1.25 mg|Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
1058959|NCT00670449|P3|Participant Flow|Placebo-fingolimod 0.5 mg|Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
1058960|NCT00670449|P2|Participant Flow|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
1058961|NCT00670449|P1|Participant Flow|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
1058962|NCT00670449|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study. These patients were either subsequently re-randomized to FTY720 (either 1.25 mg or 0.5 mg) in the Extension study, or did not enter the Extension study.
1058963|NCT00670449|O2|Outcome|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
1058964|NCT00670449|O1|Outcome|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
1058965|NCT00670449|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study. These patients were either subsequently re-randomized to FTY720 (either 1.25 mg or 0.5 mg) in the Extension study, or did not enter the Extension study.
1058966|NCT00670449|O2|Outcome|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
1058967|NCT00670449|O1|Outcome|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
1058968|NCT00670449|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study. These patients were either subsequently re-randomized to FTY720 (either 1.25 mg or 0.5 mg) in the Extension study, or did not enter the Extension study.
1058969|NCT00670449|O2|Outcome|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
1058970|NCT00670449|O1|Outcome|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
1058971|NCT00670449|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study. These patients were either subsequently re-randomized to FTY720 (either 1.25 mg or 0.5 mg) in the Extension study, or did not enter the Extension study.
1058972|NCT00670449|O2|Outcome|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
1058973|NCT00670449|O1|Outcome|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
1058974|NCT00670449|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study. These patients were either subsequently re-randomized to FTY720 (either 1.25 mg or 0.5 mg) in the Extension study, or did not enter the Extension study.
1058975|NCT00670449|O2|Outcome|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
1058976|NCT00670449|O1|Outcome|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
1058977|NCT00670449|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study. These patients were either subsequently re-randomized to FTY720 (either 1.25 mg or 0.5 mg) in the Extension study, or did not enter the Extension study.
1058978|NCT00670449|O2|Outcome|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
1058979|NCT00670449|O1|Outcome|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
1058980|NCT00670449|E4|Reported Event|Placebo-fingolimod 0.5 mg|Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
1058981|NCT00670449|E3|Reported Event|Placebo-fingolimod 1.25 mg|Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
1058982|NCT00670449|E2|Reported Event|Fingolimod 0.5 mg|Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
1058983|NCT00670449|E1|Reported Event|Fingolimod 1.25 mg|Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
1058984|NCT00670306|B1|Baseline|Cetrorelix 78 mg|Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
1058994|NCT00670267|O1|Outcome|Open Label Treatment With Oral Nadolol|"Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated.~nadolol: Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in."
1058995|NCT00670267|E1|Reported Event|Open Label|nadolol: Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.
1058996|NCT00670241|B4|Baseline|Total|Total of all reporting groups
1058997|NCT00670241|B3|Baseline|Gel Vehicle|Gel Vehicle for up to 8 weeks
1058998|NCT00670241|B2|Baseline|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
1058999|NCT00670241|B1|Baseline|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
1059000|NCT00670241|P3|Participant Flow|Gel Vehicle|Gel Vehicle for up to 8 weeks
1059001|NCT00670241|P2|Participant Flow|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
1059002|NCT00670241|P1|Participant Flow|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
1059003|NCT00670241|O3|Outcome|Gel Vehicle|Gel Vehicle for up to 8 weeks
1059004|NCT00670241|O2|Outcome|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
1059005|NCT00670241|O1|Outcome|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
1059006|NCT00670241|O3|Outcome|Gel Vehicle|Gel Vehicle for up to 8 weeks
1059007|NCT00670241|O2|Outcome|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
1059008|NCT00670241|O1|Outcome|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
1059009|NCT00670241|O3|Outcome|Gel Vehicle|Gel Vehicle for up to 8 weeks
1059010|NCT00670241|O2|Outcome|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
1059011|NCT00670241|O1|Outcome|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
1059012|NCT00670241|O3|Outcome|Gel Vehicle|Gel Vehicle for up to 8 weeks
1059013|NCT00670241|O2|Outcome|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
1059014|NCT00670241|O1|Outcome|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
1059015|NCT00670241|O3|Outcome|Gel Vehicle|Gel Vehicle for up to 8 weeks
1059016|NCT00670241|O2|Outcome|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
1059017|NCT00670241|O1|Outcome|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
1059018|NCT00670241|E3|Reported Event|Gel Vehicle|Gel Vehicle for up to 8 weeks
1059019|NCT00670241|E2|Reported Event|Tacalcitol Ointment|Tacalcitol Ointment for up to 8 weeks
1059020|NCT00670241|E1|Reported Event|Calcipotriol Plus Betamethasone Dipropionate Gel|Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
1059021|NCT00670228|B3|Baseline|Total|Total of all reporting groups
1059022|NCT00670228|B2|Baseline|Standard Glycemic Care (SGC)|"In SGC arm Subjects assigned to standard of care received subcutaneous regular insulin per sliding scale."
1059023|NCT00670228|B1|Baseline|Intensive Insulin Therapy (IIT)|In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
1059024|NCT00670228|P2|Participant Flow|Standard Glycemic Care (SGC)|"In SGC arm Subjects assigned to standard of care received subcutaneous regular insulin per sliding scale."
1059025|NCT00670228|P1|Participant Flow|Intensive Insulin Therapy (IIT)|In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
1059026|NCT00670228|O2|Outcome|Standard Glycemic Care (SGC)|"In SGC arm Subjects assigned to standard of care received subcutaneous regular insulin per sliding scale."
1059027|NCT00670228|O1|Outcome|Intensive Insulin Therapy (IIT)|In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
1059028|NCT00670228|O2|Outcome|Standard Glycemic Care (SGC)|"In SGC arm Subjects assigned to standard of care received subcutaneous regular insulin per sliding scale."
1059029|NCT00670228|O1|Outcome|Intensive Insulin Therapy (IIT)|In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
1059030|NCT00670228|O2|Outcome|Standard Glycemic Care (SGC)|"In SGC arm Subjects assigned to standard of care received subcutaneous regular insulin per sliding scale."
1059031|NCT00670228|O1|Outcome|Intensive Insulin Therapy (IIT)|In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
1059032|NCT00670228|O2|Outcome|Standard Glycemic Care (SGC)|"In SGC arm Subjects assigned to standard of care received subcutaneous regular insulin per sliding scale."
1059033|NCT00670228|O1|Outcome|Intensive Insulin Therapy (IIT)|In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
1059034|NCT00670228|E2|Reported Event|Standard Glycemic Care (SGC)|"In SGC arm Subjects assigned to standard of care received subcutaneous regular insulin per sliding scale."
1059035|NCT00670228|E1|Reported Event|Intensive Insulin Therapy (IIT)|In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL
1059036|NCT00670202|B3|Baseline|Total|Total of all reporting groups
1059037|NCT00670202|B2|Baseline|Drug: Placebo|"Placebo 1 tablet three times daily x 14 days~Placebo Oral Tablet: Placebo manufactured to mimic fasudil three times a day x 14 days"
1059038|NCT00670202|B1|Baseline|Drug: Fasudil|"Fasudil 40 mg three times a day X 14 days~Fasudil Hydrochloride: Fasudil 40 mg three times a day x 14 days"
1059039|NCT00670202|P2|Participant Flow|Drug: Placebo|"Placebo 1 tablet three times daily x 14 days~Placebo Oral Tablet: Placebo manufactured to mimic fasudil three times a day x 14 days"
1059040|NCT00670202|P1|Participant Flow|Drug: Fasudil|"Fasudil 40 mg three times a day X 14 days~Fasudil Hydrochloride: Fasudil 40 mg three times a day x 14 days"
1059104|NCT00669942|B13|Baseline|Total|Total of all reporting groups
1059041|NCT00670202|O2|Outcome|Drug: Placebo Oral Tablet|"Placebo 1 tablet three times daily x 14 days~Placebo Oral Tablet: Placebo oral tablet manufactured to mimic fasudil three times a day x 14 days"
1059042|NCT00670202|O1|Outcome|Drug: Fasudil Hydrochloride|"Fasudil hydrochloride 40 mg three times a day X 14 days~Fasudil Hydrochloride: Fasudil 40 mg three times a day x 14 days"
1059043|NCT00670202|E2|Reported Event|Drug: Placebo|"Placebo 1 tablet three times daily x 14 days~Placebo Oral Tablet: Placebo manufactured to mimic fasudil three times a day x 14 days"
1059044|NCT00670202|E1|Reported Event|Drug: Fasudil|"Fasudil 40 mg three times a day X 14 days~Fasudil Hydrochloride: Fasudil 40 mg three times a day x 14 days"
1059045|NCT00670111|B4|Baseline|Total|Total of all reporting groups
1059046|NCT00670111|B3|Baseline|Non-Randomized Patients|Only implanted patients were randomized. All other patients fall into this group.
1059047|NCT00670111|B2|Baseline|Rate Adaptive Pacing (RAP) Off Then On|Rate Adaptive Pacing (RAP) Off for first cardiopulmonary exercise test (CPX) at one month, then RAP-On for second CPX at one month.
1059048|NCT00670111|B1|Baseline|Rate Adaptive Pacing (RAP) On Then Off|Rate Adaptive Pacing (RAP) On for first cardiopulmonary exercise test (CPX) at one month, then RAP-Off for second CPX at one month.
1059049|NCT00670111|P3|Participant Flow|Non-Randomized Patients|Only implanted patients were randomized. All other patients fall into this group.
1059050|NCT00670111|P2|Participant Flow|Rate Adaptive Pacing (RAP) Off Then On|Rate Adaptive Pacing (RAP) Off for first cardiopulmonary exercise test (CPX) at one month, then RAP-On for second CPX at one month.
1059051|NCT00670111|P1|Participant Flow|Rate Adaptive Pacing (RAP) On Then Off|Rate Adaptive Pacing (RAP) On for first cardiopulmonary exercise test (CPX) at one month, then RAP-Off for second CPX at one month.
1059052|NCT00670111|O2|Outcome|Rate Adaptive Pacing (RAP) Off at One Month|Rate Adaptive Pacing (RAP) Off for first cardiopulmonary exercise test (CPX) at one month, then RAP-On for second CPX at one month.
1059053|NCT00670111|O1|Outcome|Rate Adaptive Pacing (RAP) On at Six Months|Rate Adaptive Pacing (RAP) On for first cardiopulmonary exercise test (CPX) at one month, then RAP-Off for second CPX at one month.
1059054|NCT00670111|O2|Outcome|Rate Adaptive Pacing (RAP) Off at One Month|Rate Adaptive Pacing (RAP) Off for cardiopulmonary exercise test (CPX) at one month.
1059055|NCT00670111|O1|Outcome|Rate Adaptive Pacing (RAP) On at One Month|Rate Adaptive Pacing (RAP) On for cardiopulmonary exercise test (CPX) at one month.
1059056|NCT00670111|E2|Reported Event|Non-Randomized Patients|Only implanted patients were randomized. All other patients fall into this group. Adverse events were collected for all subjects, also for non-randomized patients.
1059057|NCT00670111|E1|Reported Event|All Implanted Patients|All patients from the RAP On then Off group and from the RAP Off then On group.
1059058|NCT00670007|B1|Baseline|Zemaira®|Alpha1- proteinase inhibitor [human]: Lyophilized preparation of 60 mg/kg body weight intravenously once per week
1059059|NCT00670007|P1|Participant Flow|Zemaira®|Alpha1- proteinase inhibitor [human]: Lyophilized preparation of 60 mg/kg body weight administered intravenously once per week
1059060|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
1059061|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
1059062|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
1059063|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
1059064|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
1059065|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
1059066|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
1059067|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
1059068|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
1059069|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
1059070|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
1059071|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
1059072|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
1059073|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
1059074|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
1059075|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
1059076|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
1059077|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
1059078|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
1059079|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
1059080|NCT00670007|O2|Outcome|Zemaira® (Delayed Start)|Subjects who received placebo in study CE1226_4001 and only began to receive Zemaira® treatment upon entry into study CE1226_3001 represent the Delayed Start group. This group had a maximal exposure of 2 years at the end of study CE1226_3001.
1059081|NCT00670007|O1|Outcome|Zemaira® (Early Start)|Those subjects who had already been allocated to receive Zemaira® treatment during study CE1226_4001 represent the Early Start group. This group had received up to 4 years of continuous therapy at the end of study CE1226_3001.
1059082|NCT00670007|E1|Reported Event|Zemaira®|The safety population comprised all subjects enrolled in study CE1226_3001 and who received at least 1 administration of Zemaira® during study CE1226_3001.
1059083|NCT00669955|B3|Baseline|Total|Total of all reporting groups
1059084|NCT00669955|B2|Baseline|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
1059085|NCT00669955|B1|Baseline|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
1059086|NCT00669955|P2|Participant Flow|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
1059087|NCT00669955|P1|Participant Flow|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
1059088|NCT00669955|O2|Outcome|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
1059089|NCT00669955|O1|Outcome|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
1059090|NCT00669955|O2|Outcome|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
1059091|NCT00669955|O1|Outcome|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
1059092|NCT00669955|O2|Outcome|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
1059093|NCT00669955|O1|Outcome|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
1059094|NCT00669955|O2|Outcome|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
1059095|NCT00669955|O1|Outcome|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
1059096|NCT00669955|O2|Outcome|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
1059097|NCT00669955|O1|Outcome|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
1059098|NCT00669955|O2|Outcome|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
1059099|NCT00669955|O1|Outcome|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
1059100|NCT00669955|O2|Outcome|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
1059101|NCT00669955|O1|Outcome|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
1059102|NCT00669955|E2|Reported Event|Triple Therapy (OAC) 7 Days|Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
1059103|NCT00669955|E1|Reported Event|Quadruple Therapy (OBMT) 10 Days|Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day)
1059106|NCT00669942|B11|Baseline|Part 1 - Healthy Volunteers - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as a single dose.
1059107|NCT00669942|B10|Baseline|Part 1 - Healthy Volunteers - AIN457A 3 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
1059108|NCT00669942|B9|Baseline|Parts 2 and 3 - Placebo|Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059109|NCT00669942|B8|Baseline|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059110|NCT00669942|B7|Baseline|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059111|NCT00669942|B6|Baseline|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059112|NCT00669942|B5|Baseline|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose.
1059113|NCT00669942|B4|Baseline|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
1059114|NCT00669942|B3|Baseline|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
1059115|NCT00669942|B2|Baseline|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
1059116|NCT00669942|B1|Baseline|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
1059117|NCT00669942|P12|Participant Flow|Part 1 - Healthy Volunteers - Placebo|Placebo to AIN457A was administered intravenously as a single dose.
1059118|NCT00669942|P11|Participant Flow|Part 1 - Healthy Volunteers - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as a single dose.
1059119|NCT00669942|P10|Participant Flow|Part 1 - Healthy Volunteers - AIN457A 3 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
1059120|NCT00669942|P9|Participant Flow|Parts 2 and 3 - Placebo|Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059121|NCT00669942|P8|Participant Flow|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059122|NCT00669942|P7|Participant Flow|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059123|NCT00669942|P6|Participant Flow|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059124|NCT00669942|P5|Participant Flow|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose.
1059125|NCT00669942|P4|Participant Flow|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
1059126|NCT00669942|P3|Participant Flow|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
1059127|NCT00669942|P2|Participant Flow|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
1059128|NCT00669942|P1|Participant Flow|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
1059129|NCT00669942|O2|Outcome|Parts 2 and 3 - Placebo|Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059130|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059131|NCT00669942|O2|Outcome|Parts 2 and 3 - Placebo|Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059132|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059133|NCT00669942|O3|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059134|NCT00669942|O2|Outcome|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059135|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059136|NCT00669942|O3|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059137|NCT00669942|O2|Outcome|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059138|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059139|NCT00669942|O3|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059140|NCT00669942|O2|Outcome|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059141|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059142|NCT00669942|O3|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059143|NCT00669942|O2|Outcome|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059144|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1065525|NCT00654368|B4|Baseline|Total|Total of all reporting groups
1059145|NCT00669942|O3|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059146|NCT00669942|O2|Outcome|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059147|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059148|NCT00669942|O3|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059149|NCT00669942|O2|Outcome|Parts 2 and 3 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059150|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059151|NCT00669942|O4|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
1059152|NCT00669942|O3|Outcome|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
1059153|NCT00669942|O2|Outcome|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
1059154|NCT00669942|O1|Outcome|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
1059155|NCT00669942|O4|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
1059156|NCT00669942|O3|Outcome|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
1059157|NCT00669942|O2|Outcome|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
1059158|NCT00669942|O1|Outcome|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
1059159|NCT00669942|O4|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
1059160|NCT00669942|O3|Outcome|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
1059161|NCT00669942|O2|Outcome|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
1059162|NCT00669942|O1|Outcome|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
1059163|NCT00669942|O4|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
1059164|NCT00669942|O3|Outcome|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
1059165|NCT00669942|O2|Outcome|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
1059166|NCT00669942|O1|Outcome|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
1059167|NCT00669942|O4|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
1059168|NCT00669942|O3|Outcome|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
1059169|NCT00669942|O2|Outcome|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
1059170|NCT00669942|O1|Outcome|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
1059171|NCT00669942|O4|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
1059172|NCT00669942|O3|Outcome|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
1059173|NCT00669942|O2|Outcome|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
1059174|NCT00669942|O1|Outcome|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
1059175|NCT00669942|O2|Outcome|Parts 2 and 3 - Placebo|Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059176|NCT00669942|O1|Outcome|Parts 2 and 3 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059177|NCT00669942|E12|Reported Event|Part 1 - Healthy Volunteers - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as a single dose.
1059178|NCT00669942|E11|Reported Event|Part 1 - Healthy Volunteers - Placebo|Placebo to AIN457A was administered intravenously as a single dose.
1059179|NCT00669942|E10|Reported Event|Part 1 - Healthy Volunteers - AIN457A 3 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
1059180|NCT00669942|E9|Reported Event|Parts 2 and 3 - Placebo|Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059181|NCT00669942|E8|Reported Event|Parts 2 and 3 - AIN457 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059182|NCT00669942|E7|Reported Event|Parts 2 and 3 - AIN457 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059183|NCT00669942|E6|Reported Event|Parts 2 and 3 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1059184|NCT00669942|E5|Reported Event|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose.
1059185|NCT00669942|E4|Reported Event|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
1059186|NCT00669942|E3|Reported Event|Part 1 - AIN457A 3.0 mg/kg|AIN457A 3.0 mg/kg was administered intravenously as a single dose.
1059187|NCT00669942|E2|Reported Event|Part 1 - AIN457A 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as a single dose.
1059188|NCT00669942|E1|Reported Event|Part 1 - AIN457A 0.3 mg/kg|AIN457A 0.3 mg/kg was administered intravenously as a single dose.
1059189|NCT00669916|B3|Baseline|Total|Total of all reporting groups
1059190|NCT00669916|B2|Baseline|Placebo|Placebo was administered intravenously as a single dose.
1065897|NCT00653133|P2|Participant Flow|NSPNB|Stimulator guided nerve block
1059193|NCT00669916|P1|Participant Flow|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
1059194|NCT00669916|O1|Outcome|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
1059195|NCT00669916|O2|Outcome|Placebo|Placebo was administered intravenously as a single dose.
1059196|NCT00669916|O1|Outcome|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
1059197|NCT00669916|O1|Outcome|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
1059198|NCT00669916|O1|Outcome|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
1059199|NCT00669916|O1|Outcome|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
1059200|NCT00669916|O1|Outcome|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
1059201|NCT00669916|O1|Outcome|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
1059202|NCT00669916|O2|Outcome|Placebo|Placebo was administered intravenously as a single dose.
1059203|NCT00669916|O1|Outcome|AIN457|AIN457A 3mg/kg was administered intravenously as a single dose.
1059204|NCT00669916|E2|Reported Event|Placebo|Placebo was administered intravenously as a single dose.
1059205|NCT00669916|E1|Reported Event|AIN457A|AIN457A 3mg/kg was administered intravenously as a single dose.
1059206|NCT00669903|B5|Baseline|Total|Total of all reporting groups
1059207|NCT00669903|B4|Baseline|Placebo|Placebo
1059208|NCT00669903|B3|Baseline|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
1059209|NCT00669903|B2|Baseline|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
1059210|NCT00669903|B1|Baseline|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
1059211|NCT00669903|P4|Participant Flow|Placebo|Placebo
1059212|NCT00669903|P3|Participant Flow|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
1059213|NCT00669903|P2|Participant Flow|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
1059214|NCT00669903|P1|Participant Flow|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
1059215|NCT00669903|O4|Outcome|Placebo|Placebo
1059216|NCT00669903|O3|Outcome|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
1059217|NCT00669903|O2|Outcome|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
1059218|NCT00669903|O1|Outcome|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
1059219|NCT00669903|O4|Outcome|Placebo|Placebo
1059220|NCT00669903|O3|Outcome|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
1059221|NCT00669903|O2|Outcome|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
1059222|NCT00669903|O1|Outcome|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
1059223|NCT00669903|O4|Outcome|Placebo|Placebo
1059224|NCT00669903|O3|Outcome|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
1059225|NCT00669903|O2|Outcome|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
1059226|NCT00669903|O1|Outcome|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
1059227|NCT00669903|O4|Outcome|Placebo|Placebo
1059228|NCT00669903|O3|Outcome|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
1059229|NCT00669903|O2|Outcome|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
1059230|NCT00669903|O1|Outcome|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
1059231|NCT00669903|O4|Outcome|Placebo|Placebo
1059232|NCT00669903|O3|Outcome|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
1059233|NCT00669903|O2|Outcome|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
1059234|NCT00669903|O1|Outcome|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
1059235|NCT00669903|O4|Outcome|Placebo|Placebo
1059236|NCT00669903|O3|Outcome|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
1059237|NCT00669903|O2|Outcome|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
1059238|NCT00669903|O1|Outcome|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
1059239|NCT00669903|E4|Reported Event|Placebo|Placebo
1059240|NCT00669903|E3|Reported Event|AZD0328 High Dose Group|AZD0328 High dose group (0.075 to 0.675 mg oral solution)
1059241|NCT00669903|E2|Reported Event|AZD0328 Optimal Dose Group|AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)
1059242|NCT00669903|E1|Reported Event|AZD0328 Low Dose Group|AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)
1059243|NCT00669864|B1|Baseline|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
1059244|NCT00669864|P1|Participant Flow|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
1059245|NCT00669864|O1|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
1059246|NCT00669864|O1|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
1059247|NCT00669864|O1|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
1059248|NCT00669864|O1|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
1059249|NCT00669864|O1|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
1068469|NCT00642694|B2|Baseline|Escitalopram + Placebo|Placebo augmentation
1059250|NCT00669864|O1|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
1059251|NCT00669864|E1|Reported Event|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
1059252|NCT00669682|B1|Baseline|Group A|The study group will include Class III to IV heart failure patients followed in the device clinic that have a chronically implanted (more than 90 days) Medtronic biventricular defibrillator with the ability to monitor intrathoracic impedance.
1059253|NCT00669682|P1|Participant Flow|Group A|The study group will include Class III to IV heart failure patients followed in the device clinic that have a chronically implanted (more than 90 days) Medtronic biventricular defibrillator with the ability to monitor intrathoracic impedance.
1059254|NCT00669682|O2|Outcome|Negative Optivol Status|These patients have transthoracic impedance measurements that do not suggest fluid overload
1059255|NCT00669682|O1|Outcome|Positive Optivol Status|These patients have transthoracic impedance measurements that suggest fluid overload
1059256|NCT00669682|E1|Reported Event|Group A|The study group will include Class III to IV heart failure patients followed in the device clinic that have a chronically implanted (more than 90 days) Medtronic biventricular defibrillator with the ability to monitor intrathoracic impedance.
1059257|NCT00669617|B1|Baseline|Total Population|Participants were randomized to one of five treatment sequences. Each treatment sequence comprised 5 double-blind, single dose treatment periods (Periods I to V), separated by a washout period of 4-7 days. Participants received each of the 5 blinded-treatments: indacaterol 150 μg, indacaterol 300 μg, salmeterol/fluticasone 50/500 μg, salbutamol 200 μg and placebo.
1059258|NCT00669617|P5|Participant Flow|Placebo, Salbut, Salm/Flut , Ind 300μg, Ind 150μg|Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Placebo, Salbutamol 200 μg (Salbut), Salmeterol/fluticasone 50/500 μg (Salm/Flut), Indacaterol 300 μg (Ind 300μg), Indacaterol 150 μg (Ind 150μg). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1059259|NCT00669617|P4|Participant Flow|Salbut, Ind 300μg, Placebo, Ind 150μg, Salm/Flut|Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Salbutamol 200 μg (Salbut), Indacaterol 300 μg (Ind 300μg), Placebo, Indacaterol 150 μg (Ind 150μg), Salmeterol/fluticasone 50/500 μg (Salm/flut). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1059260|NCT00669617|P3|Participant Flow|Salm/Flut, Placebo, Ind 150μg, Salbut, Ind 300μg|Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Salmeterol/fluticasone 50/500 μg (Salm/flut), Placebo, Indacaterol 150 μg (Ind 150μg), Salbutamol 200 μg (Salbut), Indacaterol 300 μg (Ind 300μg). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1059261|NCT00669617|P2|Participant Flow|Ind 300μg, Ind 150μg, Salbut, Salm/Flut, Placebo|Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Indacaterol 300 μg (Ind 300μg), Indacaterol 150 μg (Ind 150μg), Salbutamol 200 μg (Salbut), Salmeterol/fluticasone 50/500 μg (Salm/flut), Placebo. At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1059262|NCT00669617|P1|Participant Flow|Ind 150μg, Salm/Flut, Ind 300μg, Placebo, Salbut|Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Indacaterol 150 μg (Ind 150μg), Salmeterol/fluticasone 50/500 μg (Salm/flut), Indacaterol 300 μg (Ind 300μg), Placebo, Salbutamol 200 μg (Salbut). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1059263|NCT00669617|O5|Outcome|Salbutamol|Participants received a single dose of Salbutamol 200 µg delivered via MDDPI, a placebo to indacaterol delivered via SDDPI and placebo to salmeterol/fluticasone delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1059264|NCT00669617|O4|Outcome|Salmeterol/Fluticasone|Participants received a single dose of Salmeterol/fluticasone 50/500 µg delivered via MDDPI, a placebo to indacaterol delivered via SDDPI and placebo to salbutamol delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1059265|NCT00669617|O3|Outcome|Placebo|Participants received placebo to indacaterol delivered via Single-Dose Dry-Powder Inhaler (SDDPI), a placebo to salmeterol/fluticasone delivered via Multi-Dose Dry-Powder (MDDPI) and placebo to salbutamol delivered via MDDPI. Each treatment period lasted up to 2 hours following study drug administration and was separated from the previous one by a washout period of 4 to 7 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1059285|NCT00669578|O1|Outcome|Phase II|All patients enrolled to this Phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
1068475|NCT00642694|O2|Outcome|Escitalopram + Placebp|control group
1059266|NCT00669617|O2|Outcome|Indacaterol 300 µg|Participants received a single dose of Indacaterol 300 µg delivered via a Single-Dose Dry-Powder Inhaler (SDDPI), a placebo to salmeterol/fluticasone delivered via Multi-Dose Dry-Powder Inhaler (MDDPI) and a placebo to salbutamol delivered via MDDPI. Each treatment period lasted up to 2 hours following study drug administration and was separated from the previous treatment by a washout period of 4 to 7 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1059267|NCT00669617|O1|Outcome|Indacaterol 150 µg|Participants received a single dose of Indacaterol 150 µg delivered via a Single-Dose Dry-Powder Inhaler (SDDPI), placebo to salmeterol/fluticasone delivered via Multi-Dose Dry-Powder Inhaler (MDDPI) and placebo to salbutamol delivered via MDDPI. Each treatment period lasted up to 2 hours following study drug administration and was separated from the previous treatment by a washout period of 4 to 7 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1059268|NCT00669617|E5|Reported Event|Placebo|Participants received placebo to indacaterol delivered via SDDPI, a placebo to salmeterol/fluticasone delivered via MDDPI and placebo to salbutamol delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1059269|NCT00669617|E4|Reported Event|Salmeterol/Fluticasone|Participants received a single dose of Salmeterol/fluticasone 50/500 µg delivered via MDDPI, a placebo to indacaterol delivered via SDDPI and placebo to salbutamol delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1059270|NCT00669617|E3|Reported Event|Salbutamol|Participants received a single dose of Salbutamol 200 µg delivered via MDDPI, a placebo to indacaterol delivered via SDDPI and placebo to salmeterol/fluticasone delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1059271|NCT00669617|E2|Reported Event|Indacaterol 300 µg|Participants received a single dose of Indacaterol 300 µg delivered via Single-Dose Dry-Powder Inhaler (SDDPI), a placebo to salmeterol/fluticasone delivered via Multi-Dose Dry-Powder Inhaler (MDDPI) and placebo to salbutamol delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1059272|NCT00669617|E1|Reported Event|Indacaterol 150 µg|Participants received a single dose of Indacaterol 150 µg delivered via a Single-Dose Dry-Powder Inhaler (SDDPI), placebo to salmeterol/fluticasone delivered via Multi-Dose Dry-Powder Inhaler (MDDPI) and placebo to salbutamol delivered via MDDPI. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1059273|NCT00669578|B3|Baseline|Total|Total of all reporting groups
1059274|NCT00669578|B2|Baseline|Phase I|Participants were accrued to the Phase I portion of this study in each of the 2.5, 3.0, and 3.5 mg dose cohorts to determine the Maximum Tolerated Dose (MTD). Dose limiting Toxicities (DLT) were observed at the 3.5 mg level, and the 3 mg level was confirmed as the maximum tolerated dose. For this study a DLT was defined as a grade 4 hematologic toxicity, a grade 3 or higher febrile neutropenia, or a grade 3 or higher non-hematologic toxicity.
1059275|NCT00669578|B1|Baseline|Phase II|All patients enrolled to this Phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
1059276|NCT00669578|P2|Participant Flow|Phase II|All patients enrolled to this phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
1059277|NCT00669578|P1|Participant Flow|Phase I|Participants were accrued to the Phase I portion of this study in each of the 2.5, 3.0, and 3.5 mg dose cohorts to determine the Maximum Tolerated Dose (MTD). Dose limiting Toxicities (DLT) were observed at the 3.5 mg level, and the 3 mg level was confirmed as the maximum tolerated dose. For this study a DLT was defined as a grade 4 hematologic toxicity, a grade 3 or higher febrile neutropenia, or a grade 3 or higher non-hematologic toxicity.
1059278|NCT00669578|O2|Outcome|Phase I|Participants were accrued to the Phase I portion of this study in each of the 2.5, 3.0, and 3.5 mg dose cohorts to determine the Maximum Tolerated Dose (MTD). Dose limiting Toxicities (DLT) were observed at the 3.5 mg level, and the 3 mg level was confirmed as the maximum tolerated dose. For this study a DLT was defined as a grade 4 hematologic toxicity, a grade 3 or higher febrile neutropenia, or a grade 3 or higher non-hematologic toxicity.
1059279|NCT00669578|O1|Outcome|Phase II|All patients enrolled to this Phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
1059280|NCT00669578|O2|Outcome|Phase I|Participants were accrued to the Phase I portion of this study in each of the 2.5, 3.0, and 3.5 mg dose cohorts to determine the Maximum Tolerated Dose (MTD). Dose limiting Toxicities (DLT) were observed at the 3.5 mg level, and the 3 mg level was confirmed as the maximum tolerated dose. For this study a DLT was defined as a grade 4 hematologic toxicity, a grade 3 or higher febrile neutropenia, or a grade 3 or higher non-hematologic toxicity.
1059281|NCT00669578|O1|Outcome|Phase II|All patients enrolled to this Phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
1059282|NCT00669578|O2|Outcome|Phase I|Participants were accrued to the Phase I portion of this study in each of the 2.5, 3.0, and 3.5 mg dose cohorts to determine the Maximum Tolerated Dose (MTD). Dose limiting Toxicities (DLT) were observed at the 3.5 mg level, and the 3 mg level was confirmed as the maximum tolerated dose. For this study a DLT was defined as a grade 4 hematologic toxicity, a grade 3 or higher febrile neutropenia, or a grade 3 or higher non-hematologic toxicity.
1059283|NCT00669578|O1|Outcome|Phase II|All patients enrolled to this Phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
1059284|NCT00669578|O2|Outcome|Phase I|Participants were accrued to the Phase I portion of this study in each of the 2.5, 3.0, and 3.5 mg dose cohorts to determine the Maximum Tolerated Dose (MTD). Dose limiting Toxicities (DLT) were observed at the 3.5 mg level, and the 3 mg level was confirmed as the maximum tolerated dose. For this study a DLT was defined as a grade 4 hematologic toxicity, a grade 3 or higher febrile neutropenia, or a grade 3 or higher non-hematologic toxicity.
1059330|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
1059286|NCT00669578|O2|Outcome|Phase II|All patients enrolled to this phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
1059287|NCT00669578|O1|Outcome|Phase I|Participants were accrued to the Phase I portion of this study in each of the 2.5, 3.0, and 3.5 mg dose cohorts to determine the Maximum Tolerated Dose (MTD). Dose limiting Toxicities (DLT) were observed at the 3.5 mg level, and the 3 mg level was confirmed as the maximum tolerated dose. For this study a DLT was defined as a grade 4 hematologic toxicity, a grade 3 or higher febrile neutropenia, or a grade 3 or higher non-hematologic toxicity.
1059288|NCT00669578|E1|Reported Event|Phase II|All patients enrolled to this Phase II arm started treatment at 0.5mg/day with CC-4047 every day of each 28 day cycle.
1059289|NCT00669552|B1|Baseline|Medtronic Defibrillator|Patients undergoing a percutaneous coronary intervention (PCI) with an implanted Medtronic defibrillator with the capability of telemetry of the intracardiac signal.
1059290|NCT00669552|P1|Participant Flow|Medtronic Defibrillator|Patients undergoing a percutaneous coronary intervention (PCI) with an implanted Medtronic defibrillator with the capability of telemetry of the intracardiac signal.
1059291|NCT00669552|O1|Outcome|Medtronic Defibrillator|Patients undergoing a percutaneous coronary intervention (PCI) with an implanted Medtronic defibrillator with the capability of telemetry of the intracardiac signal.
1059292|NCT00669552|E1|Reported Event|Medtronic Defibrillator|Patients undergoing a percutaneous coronary intervention (PCI) with an implanted Medtronic defibrillator with the capability of telemetry of the intracardiac signal.
1059293|NCT00669539|B3|Baseline|Total|Total of all reporting groups
1059294|NCT00669539|B2|Baseline|Strabismus-Only Amblyopia|Chilren with pure strabismus who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
1059295|NCT00669539|B1|Baseline|Combined-Mechanism Amblyopia|Chilren with strabismus and anisometropia who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
1059296|NCT00669539|P2|Participant Flow|Strabismus-Only Amblyopia|Chilren with pure strabismus who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
1059297|NCT00669539|P1|Participant Flow|Combined-Mechanism Amblyopia|Chilren with strabismus and anisometropia who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
1059298|NCT00669539|O2|Outcome|Strabismus-Only Amblyopia|Chilren with pure strabismus who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
1059299|NCT00669539|O1|Outcome|Combined-Mechanism Amblyopia|Chilren with strabismus and anisometropia who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
1059300|NCT00669539|E2|Reported Event|Strabismus-Only Amblyopia|Chilren with pure strabismus who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
1059301|NCT00669539|E1|Reported Event|Combined-Mechanism Amblyopia|Chilren with strabismus and anisometropia who were prescribed refractive error correction with spectacles. The eye with worse visual acuity was labeled the amblyopic eye; the eye with better visual acuity was labeled the fellow eye. All analyses included only 1 observation per participant.
1059302|NCT00669461|B1|Baseline|Lubiprostone|patient received treatment( lubiprostone)24 mcg po BID for 4 weeks
1059303|NCT00669461|P1|Participant Flow|Lubiprostone|patient received treatment( lubiprostone)24 mcg po BID for 4 weeks
1059304|NCT00669461|O1|Outcome|Lubiprostone|patient received treatment( lubiprostone)24 mcg po BID for 4 weeks
1059305|NCT00669461|O1|Outcome|Lubiprostone|Lubiprostone 24 micrograms po BID given for total of 4 weeks
1059306|NCT00669461|E1|Reported Event|Lubiprostone|patient received treatment( lubiprostone)24 mcg po BID for 4 weeks
1059307|NCT00669396|B3|Baseline|Total|Total of all reporting groups
1059308|NCT00669396|B2|Baseline|Levonorgestrel|Oral levonorgestrel
1059309|NCT00669396|B1|Baseline|Copper T380 IUD|IUD
1059310|NCT00669396|P2|Participant Flow|Levonorgestrel|Oral levonorgestrel
1059311|NCT00669396|P1|Participant Flow|Copper T380 IUD|IUD
1059312|NCT00669396|O2|Outcome|Levonorgestrel|Oral levonorgestrel
1059313|NCT00669396|O1|Outcome|Copper T380 IUD|IUD
1059314|NCT00669396|O2|Outcome|Levonorgestrel|Oral levonorgestrel
1059315|NCT00669396|O1|Outcome|Copper T380 IUD|IUD
1059316|NCT00669396|O2|Outcome|Levonorgestrel|Oral levonorgestrel
1059317|NCT00669396|O1|Outcome|Copper T380 IUD|IUD
1059318|NCT00669396|O2|Outcome|Levonorgestrel|Oral levonorgestrel
1059319|NCT00669396|O1|Outcome|Copper T380 IUD|IUD
1059320|NCT00669396|E2|Reported Event|Levonorgestrel|Oral levonorgestrel
1059321|NCT00669396|E1|Reported Event|Copper T380 IUD|IUD
1059322|NCT00669331|B3|Baseline|Total|Total of all reporting groups
1059323|NCT00669331|B2|Baseline|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
1059324|NCT00669331|B1|Baseline|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
1059325|NCT00669331|P2|Participant Flow|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
1059326|NCT00669331|P1|Participant Flow|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
1059327|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
1059328|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
1059329|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
1068476|NCT00642694|O1|Outcome|Escitalopram + Ramelteon|active augmentation
1059333|NCT00669331|O2|Outcome|Control|"Matched control - inhaled mannitol 50mg~Matched control: 50mg dose of Mannitol BD for 52 weeks"
1059334|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol 400mg~Inhaled mannitol: 400mg dose of Mannitol BD for 52 weeks"
1059335|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
1059336|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
1059337|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
1059338|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
1059339|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
1059340|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
1059341|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
1059342|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
1059343|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
1059344|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
1059345|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
1059346|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
1059347|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
1059348|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
1059349|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
1059350|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
1059351|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
1059352|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
1059353|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
1059354|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
1059355|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
1059356|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
1059357|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
1059358|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
1059359|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
1059360|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
1059361|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
1059362|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
1059363|NCT00669331|O2|Outcome|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
1059364|NCT00669331|O1|Outcome|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
1059365|NCT00669331|E2|Reported Event|Control|Matched control: Inhaled mannitol 50mg BD for 52 weeks
1059366|NCT00669331|E1|Reported Event|Mannitol|"Inhaled mannitol~Inhaled mannitol: 400mg BD for 52 weeks"
1059367|NCT00669318|B1|Baseline|Treatment (Pentostatin, Alemtuzumab, Rituximab)|"Course 1: Patients receive:~2 mg/m^2 pentostatin IV on days 8 and 22;~3 mg alemtuzumab subcutaneously (SC) on day 3;~10 mg alemtuzumab SC on day 4;~30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.~Courses 2 and 3: Patients receive:~2 mg/m^2 pentostatin IV on days 1 and 15;~30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3)."
1059368|NCT00669318|P1|Participant Flow|Treatment (Pentostatin, Alemtuzumab, Rituximab)|"Course 1: Patients receive:~2 mg/m^2 pentostatin IV on days 8 and 22;~3 mg alemtuzumab subcutaneously (SC) on day 3;~10 mg alemtuzumab SC on day 4;~30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.~Courses 2 and 3: Patients receive:~2 mg/m^2 pentostatin IV on days 1 and 15;~30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3)."
1059369|NCT00669318|O1|Outcome|Treatment (Pentostatin, Alemtuzumab, Rituximab)|"Course 1: Patients receive:~2 mg/m^2 pentostatin IV on days 8 and 22;~3 mg alemtuzumab subcutaneously (SC) on day 3;~10 mg alemtuzumab SC on day 4;~30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.~Courses 2 and 3: Patients receive:~2 mg/m^2 pentostatin IV on days 1 and 15;~30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3)."
1059370|NCT00669318|O1|Outcome|Treatment (Pentostatin, Alemtuzumab, Rituximab)|"Course 1: Patients receive:~2 mg/m^2 pentostatin IV on days 8 and 22;~3 mg alemtuzumab subcutaneously (SC) on day 3;~10 mg alemtuzumab SC on day 4;~30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.~Courses 2 and 3: Patients receive:~2 mg/m^2 pentostatin IV on days 1 and 15;~30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3)."
1059371|NCT00669318|O1|Outcome|Treatment (Pentostatin, Alemtuzumab, Rituximab)|"Course 1: Patients receive:~2 mg/m^2 pentostatin IV on days 8 and 22;~3 mg alemtuzumab subcutaneously (SC) on day 3;~10 mg alemtuzumab SC on day 4;~30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.~Courses 2 and 3: Patients receive:~2 mg/m^2 pentostatin IV on days 1 and 15;~30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3)."
1059372|NCT00669318|O1|Outcome|Treatment (Pentostatin, Alemtuzumab, Rituximab)|"Course 1: Patients receive:~2 mg/m^2 pentostatin IV on days 8 and 22;~3 mg alemtuzumab subcutaneously (SC) on day 3;~10 mg alemtuzumab SC on day 4;~30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.~Courses 2 and 3: Patients receive:~2 mg/m^2 pentostatin IV on days 1 and 15;~30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3)."
1059373|NCT00669318|O1|Outcome|Treatment (Pentostatin, Alemtuzumab, Rituximab)|"Course 1: Patients receive:~2 mg/m^2 pentostatin IV on days 8 and 22;~3 mg alemtuzumab subcutaneously (SC) on day 3;~10 mg alemtuzumab SC on day 4;~30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;~6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.~Courses 2 and 3: Patients receive:~2 mg/m^2 pentostatin IV on days 1 and 15;~30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;~6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3)."
1059374|NCT00669318|E1|Reported Event|Treatment (Pentostatin, Alemtuzumab, Rituximab)|sargramostim
1059375|NCT00669279|B3|Baseline|Total|Total of all reporting groups
1059376|NCT00669279|B2|Baseline|Atenolol|Atenolol 25 mg once daily - Forced titration occurred in atenolol to 50 mg at week one, and to 100 mg at week two.
1059377|NCT00669279|B1|Baseline|Carvedilol CR|Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two.
1059378|NCT00669279|P2|Participant Flow|Atenolol|Atenolol 25 mg once daily - Forced titration occurred in atenolol to 50 mg at week one, and to 100 mg at week two.
1059379|NCT00669279|P1|Participant Flow|Carvedilol CR|Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two.
1059380|NCT00669279|O2|Outcome|Atenolol|Atenolol 25 mg once daily - Forced titration occurred in atenolol to 50 mg at week one, and to 100 mg at week two.
1059381|NCT00669279|O1|Outcome|Carvedilol CR|Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two.
1059382|NCT00669279|E2|Reported Event|Atenolol|Atenolol 25 mg once daily - Forced titration occurred in atenolol to 50 mg at week one, and to 100 mg at week two.
1059383|NCT00669279|E1|Reported Event|Carvedilol CR|Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two.
1059384|NCT00669240|B1|Baseline|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
1059385|NCT00669240|P1|Participant Flow|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
1059386|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
1059387|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
1059388|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
1069713|NCT00639223|B2|Baseline|Red Yeast Rice|
1059389|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
1059390|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
1059391|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
1059392|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
1059393|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
1059394|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
1059395|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
1059396|NCT00669240|O1|Outcome|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
1059397|NCT00669240|E1|Reported Event|Varenicline|According to the approved Summary of Product Characteristics (SmPC), participants were required to take 0.5 milligram (mg) orally once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4-7. From Day 8 to the end of treatment, participants should have taken 1 mg twice daily. Participants who cannot tolerate adverse effects of Champix could have the dose lowered temporarily or permanently to 0.5 mg twice daily. Participants were to be treated for 12 weeks, at which time a maintenance period of 12 weeks could be prescribed. Treatment was to start 1-2 weeks prior to quitting smoking.
1059398|NCT00669214|B3|Baseline|Total|Total of all reporting groups
1059399|NCT00669214|B2|Baseline|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
1059400|NCT00669214|B1|Baseline|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
1059401|NCT00669214|P2|Participant Flow|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
1059402|NCT00669214|P1|Participant Flow|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
1059495|NCT00669032|P1|Participant Flow|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
1059403|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
1059404|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
1059405|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
1059406|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
1059407|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
1059408|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
1059409|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
1059410|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
1059411|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
1059412|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
1059413|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
1059414|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
1059415|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
1059416|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
1059417|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
1059418|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
1059419|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
1059420|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
1059421|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
1059422|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
1059423|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
1059653|NCT00668265|P2|Participant Flow|Placebo Arm|The subjects in the placebo arm received inactive pills in identical blister packs
1059424|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
1059425|NCT00669214|O2|Outcome|Efalizumab|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
1059426|NCT00669214|O1|Outcome|Placebo|All patients received a conditioning dose of placebo equivalent subcutaneously (SC) on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
1059427|NCT00669214|E6|Reported Event|Efalizumab: Follow-Up Period|
1059428|NCT00669214|E5|Reported Event|Placebo: Follow-Up Period|
1059429|NCT00669214|E4|Reported Event|Efalizumab: Open-Label Period|
1059430|NCT00669214|E3|Reported Event|Placebo: Open-Label Period|
1059431|NCT00669214|E2|Reported Event|Efalizumab: Double-Blind Period|All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).
1059432|NCT00669214|E1|Reported Event|Placebo: Double-Blind Period|All patients received a conditioning dose of placebo equivalent SC on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).
1059433|NCT00669110|B3|Baseline|Total|Total of all reporting groups
1059434|NCT00669110|B2|Baseline|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
1059435|NCT00669110|B1|Baseline|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
1059436|NCT00669110|P2|Participant Flow|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
1059437|NCT00669110|P1|Participant Flow|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
1059438|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
1059439|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
1059440|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
1059441|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
1059442|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
1059443|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
1059444|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
1059445|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
1059446|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
1059693|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
1059447|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
1059448|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
1059449|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
1059450|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
1059451|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
1059452|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
1059453|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
1059454|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
1059455|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
1059456|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
1059457|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
1059458|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
1059459|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
1059460|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
1059461|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
1059462|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
1059463|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
1059464|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
1059465|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
1069714|NCT00639223|B1|Baseline|Pravastatin|
1059466|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
1059467|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
1059468|NCT00669110|O2|Outcome|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
1059469|NCT00669110|O1|Outcome|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
1059470|NCT00669110|E2|Reported Event|DVS SR - Adolescents|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 25 mg, 50 mg, 100 mg, and 200 mg for adolescents 12 to 17 years of age at baseline in the preceding Core study NCT00619619.
1059471|NCT00669110|E1|Reported Event|DVS SR - Children|Desvenlafaxine succinate sustained-release (DVS SR) formulation tablet(s) by mouth (PO) administered as flexible dosing adjusted by the investigator as clinically indicated. Total daily dose will be flexible between 10 milligrams (mg), 25 mg, 50 mg, and 100 mg for children 7 to 11 years of age at baseline in the preceding Core study NCT00619619.
1059472|NCT00669071|B1|Baseline|IPL / Tri-Luma® Cream and IPL / Inactive Control Cream|Intense Pulsed Light (IPL)/fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% cream (Tri-Luma® Cream) and Intense Pulsed Light (IPL)/Cetaphil® Moisturizing Cream; Applied once daily at bedtime on one side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face.
1059473|NCT00669071|P1|Participant Flow|IPL / Tri-Luma® Cream and IPL / Inactive Control Cream|Intense Pulsed Light (IPL)/fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% cream (Tri-Luma® Cream) and Intense Pulsed Light (IPL)/Cetaphil® Moisturizing Cream; Applied once daily at bedtime on one side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face.
1059474|NCT00669071|O2|Outcome|Intense Pulsed Light (IPL) / Inactive Control Cream|Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
1059475|NCT00669071|O1|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) / fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
1059476|NCT00669071|O2|Outcome|Intense Pulsed Light (IPL) / Inactive Control Cream|Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
1059477|NCT00669071|O1|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) / fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
1059478|NCT00669071|O2|Outcome|Intense Pulsed Light (IPL) / Inactive Control Cream|Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
1059479|NCT00669071|O1|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) / fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
1059480|NCT00669071|O2|Outcome|Intense Pulsed Light (IPL) / Inactive Control Cream|Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
1059481|NCT00669071|O1|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) / fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
1059482|NCT00669071|O2|Outcome|Intense Pulsed Light (IPL) / Inactive Control Cream|Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
1059483|NCT00669071|O1|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) / fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
1059484|NCT00669071|O2|Outcome|Intense Pulsed Light (IPL) / Inactive Control Cream|Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
1059485|NCT00669071|O1|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) / fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
1059486|NCT00669071|O2|Outcome|Intense Pulsed Light (IPL) / Inactive Control Cream|Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
1059487|NCT00669071|O1|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) / fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
1059488|NCT00669071|O2|Outcome|Intense Pulsed Light (IPL) / Inactive Control Cream|Intense Pulsed Light (IPL) / Cetaphil® Moisturizing Cream
1059489|NCT00669071|O1|Outcome|Intense Pulsed Light (IPL) / Tri-Luma® Cream|Intense Pulsed Light (IPL) /fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%
1059490|NCT00669071|E1|Reported Event|IPL / Tri-Luma® Cream and IPL / Inactive Control Cream|Intense Pulsed Light (IPL)/fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% cream (Tri-Luma® Cream) and Intense Pulsed Light (IPL)/Cetaphil® Moisturizing Cream; Applied once daily at bedtime on one side of the face; this was a randomized, split face study where one cream was used on the right side of the face and the other cream on the left side of the face and IPL (Intense Pulsed Light) was used on both sides of the face.
1059491|NCT00669032|B3|Baseline|Total|Total of all reporting groups
1059492|NCT00669032|B2|Baseline|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
1059493|NCT00669032|B1|Baseline|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
1059494|NCT00669032|P2|Participant Flow|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
1059496|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
1059497|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
1059498|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
1059499|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
1059500|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
1059501|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
1059502|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
1059503|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
1059504|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
1059505|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
1059506|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
1059507|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
1059508|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
1059509|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
1059510|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
1059511|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
1059512|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
1059513|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
1059514|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
1059515|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
1059516|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
1059517|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
1059518|NCT00669032|O2|Outcome|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
1059519|NCT00669032|O1|Outcome|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
1059520|NCT00669032|E2|Reported Event|Placebo|Four cycles of 5 weekly intra-articular injections of 2.5ml saline solution with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
1059521|NCT00669032|E1|Reported Event|Hyaluronic Acid (Adant)|Four cycles of 5 weekly intra-articular injections of 2.5ml 1% sodium hyaluronate with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles.
1059522|NCT00669019|B1|Baseline|Saracatinib|Patients receive saracatinib 175 mg oral once daily in the absence of disease progression or unacceptable toxicity.
1059523|NCT00669019|P1|Participant Flow|Saracatinib|Patients receive saracatinib 175 mg oral, once daily in the absence of disease progression or unacceptable toxicity.
1059524|NCT00669019|O1|Outcome|Saracatinib|Patients receive saracatinib 175 mg oral once daily in the absence of disease progression or unacceptable toxicity.
1059525|NCT00669019|O1|Outcome|Saracatinib|Patients receive saracatinib 175 mg oral once daily in the absence of disease progression or unacceptable toxicity.
1059526|NCT00669019|E1|Reported Event|Saracatinib|Patients receive saracatinib 175 mg oral once daily in the absence of disease progression or unacceptable toxicity.
1059527|NCT00668902|B4|Baseline|Total|Total of all reporting groups
1059694|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
1059528|NCT00668902|B3|Baseline|PM of CYP2C19|"Homozygous for CYP2C19 null alleles (*2/*2, *2/*3 or *3/*3, Poor metabolizers) was measured by (13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
1059529|NCT00668902|B2|Baseline|IM of CYP2C19|"CYP2C19 activity in heterozygous for deficient CYP2C19 alleles (*2 and *3, IM of CYP2C19) was measured by (13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
1059530|NCT00668902|B1|Baseline|EM of CYP2C19|"CYP2C19 enzyme activity in extensive metabolizers of CYP2C19 (CYP2C19*1/*1 genotype, or wild type) was measured by 13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
1059531|NCT00668902|P3|Participant Flow|PM of CYP2C19|"Homozygous for CYP2C19 null alleles (*2/*2, *2/*3 or *3/*3, Poor metabolizers) was measured by (13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
1059532|NCT00668902|P2|Participant Flow|IM of CYP2C19|"CYP2C19 activity in heterozygous for deficient CYP2C19 alleles (*2 and *3, IM of CYP2C19) was measured by (13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
1059533|NCT00668902|P1|Participant Flow|EM of CYP2C19|"CYP2C19 enzyme activity in extensive metabolizers of CYP2C19 (CYP2C19*1/*1 genotype, or wild type) was measured by 13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
1059534|NCT00668902|O3|Outcome|PM of CYP2C19|"Homozygous for CYP2C19 null alleles (*2/*2, *2/*3 or *3/*3, Poor metabolizers) was measured by (13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
1059535|NCT00668902|O2|Outcome|IM of CYP2C19|"CYP2C19 activity in heterozygous for deficient CYP2C19 alleles (*2 and *3, IM of CYP2C19) was measured by (13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
1059536|NCT00668902|O1|Outcome|EM of CYP2C19|"CYP2C19 enzyme activity in extensive metabolizers of CYP2C19 (CYP2C19*1/*1 genotype, or wild type) was measured by 13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
1059537|NCT00668902|E3|Reported Event|PM of CYP2C19|"Homozygous for CYP2C19 null alleles (*2/*2, *2/*3 or *3/*3, Poor metabolizers) was measured by (13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
1059538|NCT00668902|E2|Reported Event|IM of CYP2C19|"CYP2C19 activity in heterozygous for deficient CYP2C19 alleles (*2 and *3, IM of CYP2C19) was measured by (13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
1059539|NCT00668902|E1|Reported Event|EM of CYP2C19|"CYP2C19 enzyme activity in extensive metabolizers of CYP2C19 (CYP2C19*1/*1 genotype, or wild type) was measured by 13C)Pantoprazole breath test.~[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes"
1059540|NCT00668863|B1|Baseline|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
1059541|NCT00668863|P1|Participant Flow|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
1059542|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
1059543|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
1059544|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
1059619|NCT00668434|O2|Outcome|Placebo|"Participants will receive a 15-day course of placebo capsules.~Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine."
1059545|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
1059546|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
1059547|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
1059548|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
1059549|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
1059550|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
1059551|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
1059552|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
1059553|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
1059554|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
1059555|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
1059556|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
1059649|NCT00668317|E1|Reported Event|Antacid Therapy|Therapy with omeprazole 20 mg BD and Ranitidine 300mg od nocte
1059650|NCT00668265|B3|Baseline|Total|Total of all reporting groups
1069715|NCT00639223|P2|Participant Flow|Red Yeast Rice|
1059557|NCT00668863|O1|Outcome|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
1059558|NCT00668863|E1|Reported Event|Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI|Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.
1059559|NCT00668785|B1|Baseline|Ranibizumab|Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation.
1059560|NCT00668785|P1|Participant Flow|Ranibizumab|Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation.
1059561|NCT00668785|O1|Outcome|Ranibizumab|Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation.
1059562|NCT00668785|E1|Reported Event|Ranibizumab|Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation.
1059563|NCT00668746|B3|Baseline|Total|Total of all reporting groups
1059564|NCT00668746|B2|Baseline|No Drug Intervention|A control consisting of no drug intervention
1059565|NCT00668746|B1|Baseline|Minocycline HCl Microspheres|A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm
1059566|NCT00668746|P2|Participant Flow|No Drug Intervention|A control consisting of no drug intervention
1059567|NCT00668746|P1|Participant Flow|Minocycline HCl Microspheres|A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm
1059568|NCT00668746|O6|Outcome|Control Group at Day 180|
1059569|NCT00668746|O5|Outcome|Control Group at Day 30|
1059570|NCT00668746|O4|Outcome|Control Group at Baseline|
1059571|NCT00668746|O3|Outcome|Minocycline Group at Day 180|
1059572|NCT00668746|O2|Outcome|Minocycline Group at Day 30|
1059573|NCT00668746|O1|Outcome|Minocycline Group at Baseline|
1059574|NCT00668746|O6|Outcome|Control Group at 180 Days|
1059575|NCT00668746|O5|Outcome|Control Group at 30 Days|
1059576|NCT00668746|O4|Outcome|Control Group at Baseline|
1059577|NCT00668746|O3|Outcome|Micocycline Group at 180 Days|
1059578|NCT00668746|O2|Outcome|Minocycline Group at 30 Days|
1059579|NCT00668746|O1|Outcome|Minocycline Group at Baseline|
1059580|NCT00668746|O2|Outcome|No Drug Intervention|A control consisting of no drug intervention
1059581|NCT00668746|O1|Outcome|Minocycline HCl Microspheres|A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm
1059582|NCT00668746|E2|Reported Event|No Drug Intervention|A control consisting of no drug intervention
1059583|NCT00668746|E1|Reported Event|Minocycline HCl Microspheres|A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm
1059584|NCT00668733|B3|Baseline|Total|Total of all reporting groups
1059585|NCT00668733|B2|Baseline|3-Week Treatment Group|Subjects who previously enrolled in studies GW01-0703 and GW01-0705 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
1059586|NCT00668733|B1|Baseline|2-Week Treatment Group|Subjects who previously enrolled in studies GW01-0702 and GW01-0704 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
1059587|NCT00668733|P2|Participant Flow|3-Week Treatment Group|Subjects who previously enrolled in studies GW01-0703 and GW01-0705 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
1059588|NCT00668733|P1|Participant Flow|2-Week Treatment Group|Subjects who previously enrolled in studies GW01-0702 and GW01-0704 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
1059589|NCT00668733|O2|Outcome|3-Week Treatment Group|Subjects who previously enrolled in studies GW01-0703 and GW01-0705 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
1059590|NCT00668733|O1|Outcome|2-Week Treatment Group|Subjects who previously enrolled in studies GW01-0702 and GW01-0704 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
1059591|NCT00668733|E2|Reported Event|3-Week Treatment Group|Subjects who previously enrolled in studies GW01-0703 and GW01-0705 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
1059651|NCT00668265|B2|Baseline|Placebo|Subjects on methadone maintenance receiving placebo while inpatients in a methadone treatment facility Su Casa
1059592|NCT00668733|E1|Reported Event|2-Week Treatment Group|Subjects who previously enrolled in studies GW01-0702 and GW01-0704 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study [EOS]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
1059593|NCT00668564|B1|Baseline|Intent-to-Treat|All patients treated with study regimen; Bone Marrow Transplant - cord blood transplant; Cyclophosphamide (50 mg/kg intravenous [IV] days 1-4 prior to transplant); Busulfan (if < or = 12 kg: 1.1 mg/kg or if > 12 kg: 0.8 mg/kg IV every 6 hours on days 6-9 before transplant) and Campath-1H (once per day 0.3 mg/kg IV on days 10-12 before transplant.
1059594|NCT00668564|P1|Participant Flow|Intent-to-Treat|All patients treated with study regimen; Bone Marrow Transplant - cord blood transplant; Cyclophosphamide (50 mg/kg intravenous [IV] days 1-4 prior to transplant); Busulfan (if < or = 12 kg: 1.1 mg/kg or if > 12 kg: 0.8 mg/kg IV every 6 hours on days 6-9 before transplant) and Campath-1H (once per day 0.3 mg/kg IV on days 10-12 before transplant.
1059595|NCT00668564|O1|Outcome|Intent-to-Treat|All patients treated with study regimen; Bone Marrow Transplant - cord blood transplant; Cyclophosphamide (50 mg/kg intravenous [IV] days 1-4 prior to transplant); Busulfan (if < or = 12 kg: 1.1 mg/kg or if > 12 kg: 0.8 mg/kg IV every 6 hours on days 6-9 before transplant) and Campath-1H (once per day 0.3 mg/kg IV on days 10-12 before transplant.
1059596|NCT00668564|O1|Outcome|Intent-to-Treat|All patients treated with study regimen; Bone Marrow Transplant - cord blood transplant; Cyclophosphamide (50 mg/kg intravenous [IV] days 1-4 prior to transplant); Busulfan (if < or = 12 kg: 1.1 mg/kg or if > 12 kg: 0.8 mg/kg IV every 6 hours on days 6-9 before transplant) and Campath-1H (once per day 0.3 mg/kg IV on days 10-12 before transplant.
1059597|NCT00668564|E1|Reported Event|Intent-to-Treat|All patients treated with study regimen; Bone Marrow Transplant - cord blood transplant; Cyclophosphamide (50 mg/kg intravenous [IV] days 1-4 prior to transplant); Busulfan (if < or = 12 kg: 1.1 mg/kg or if > 12 kg: 0.8 mg/kg IV every 6 hours on days 6-9 before transplant) and Campath-1H (once per day 0.3 mg/kg IV on days 10-12 before transplant.
1059598|NCT00668525|B4|Baseline|Total|Total of all reporting groups
1059599|NCT00668525|B3|Baseline|Placebo|Placebo, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
1059600|NCT00668525|B2|Baseline|Escitalopram High Dose|Escitalopram high dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
1059601|NCT00668525|B1|Baseline|Escitalopram Low Dose|Escitalopram low dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
1059602|NCT00668525|P3|Participant Flow|Placebo|Placebo, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
1059603|NCT00668525|P2|Participant Flow|Escitalopram High Dose|Escitalopram high dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
1059604|NCT00668525|P1|Participant Flow|Escitalopram Low Dose|Escitalopram low dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
1059605|NCT00668525|O3|Outcome|Placebo|Placebo, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
1059606|NCT00668525|O2|Outcome|Escitalopram High Dose|Escitalopram high dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
1059607|NCT00668525|O1|Outcome|Escitalopram Low Dose|Escitalopram low dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
1059608|NCT00668525|O3|Outcome|Placebo|Placebo, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
1059609|NCT00668525|O2|Outcome|Escitalopram High Dose|Escitalopram high dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
1059610|NCT00668525|O1|Outcome|Escitalopram Low Dose|Escitalopram low dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
1059611|NCT00668525|E3|Reported Event|Placebo|Placebo, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
1059612|NCT00668525|E2|Reported Event|Escitalopram High Dose|Escitalopram high dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
1059613|NCT00668525|E1|Reported Event|Escitalopram Low Dose|Escitalopram low dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
1059614|NCT00668434|B3|Baseline|Total|Total of all reporting groups
1059615|NCT00668434|B2|Baseline|Placebo|"Participants will receive a 15-day course of placebo capsules.~Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine."
1059616|NCT00668434|B1|Baseline|Prednisone|"Participants will receive a 15-day tapering course of prednisone capsules.~Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days."
1059617|NCT00668434|P2|Participant Flow|Placebo|"Participants will receive a 15-day course of placebo capsules.~Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine."
1059618|NCT00668434|P1|Participant Flow|Prednisone|"Participants will receive a 15-day tapering course of prednisone capsules.~Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days."
1059620|NCT00668434|O1|Outcome|Prednisone|"Participants will receive a 15-day tapering course of prednisone capsules.~Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days."
1059621|NCT00668434|O2|Outcome|Placebo|"Participants will receive a 15-day course of placebo capsules.~Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine."
1059622|NCT00668434|O1|Outcome|Prednisone|"Participants will receive a 15-day tapering course of prednisone capsules.~Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days."
1059623|NCT00668434|O2|Outcome|Placebo|"Participants will receive a 15-day course of placebo capsules.~Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine."
1059624|NCT00668434|O1|Outcome|Prednisone|"Participants will receive a 15-day tapering course of prednisone capsules.~Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days."
1059625|NCT00668434|O2|Outcome|Placebo|"Participants will receive a 15-day course of placebo capsules.~Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine."
1059626|NCT00668434|O1|Outcome|Prednisone|"Participants will receive a 15-day tapering course of prednisone capsules.~Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days."
1059627|NCT00668434|E2|Reported Event|Placebo|"Participants will receive a 15-day course of placebo capsules.~Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine."
1059628|NCT00668434|E1|Reported Event|Prednisone|"Participants will receive a 15-day tapering course of prednisone capsules.~Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days."
1059629|NCT00668395|B4|Baseline|Total|Total of all reporting groups
1059630|NCT00668395|B3|Baseline|CYP2B6*6/*6|Slow metabolizer
1059631|NCT00668395|B2|Baseline|CYP2B6*1/*6|Intermediate metabolizer
1059632|NCT00668395|B1|Baseline|CYP2B6*1/*1|Normal metabolizer
1059633|NCT00668395|P3|Participant Flow|CYP2B6*6/*6 Genotype Group|"Efavirenz clearance following a single 600 mg oral dose of efavirenz and after multiple doses of efavirenz (600 mg/day orally for 17 days) was analyzed in normal metabolizer of CYP2B6 (CYP2B6*1/*1 genotype), intermediate metabolizer (CYP2B6*1/*6 genotype) and slow metabolizer (CYP2B6*6/*6).~During the study, the design was slightly modified to sequentially enroll instead of allocation based on specific genotype, and genotype effect was analyzed post-hoc.~The activities of CYP1A2, CYP2C9, CYP2C19, CYP3A were determined in all subjects (without regard to CYP2B6 genotype) using the metabolism of isoform selective probe substrates during the single dose (600 mg efavirenz orally) and after intake of multiple doses of efavirenz (600 mg/day efavirenz orally for 17 days) to assess efavirenz mediated drug interactions."
1059634|NCT00668395|P2|Participant Flow|CYP2B6*1/*6 Genotype Group|"Efavirenz clearance following a single 600 mg oral dose of efavirenz and after multiple doses of efavirenz (600 mg/day orally for 17 days) was analyzed in normal metabolizer of CYP2B6 (CYP2B6*1/*1 genotype), intermediate metabolizer (CYP2B6*1/*6 genotype) and slow metabolizer (CYP2B6*6/*6).~During the study, the design was slightly modified to sequentially enroll instead of allocation based on specific genotype, and genotype effect was analyzed post-hoc.~The activities of CYP1A2, CYP2C9, CYP2C19, CYP3A were determined in all subjects (without regard to CYP2B6 genotype) using the metabolism of isoform selective probe substrates during the single dose (600 mg efavirenz orally) and after intake of multiple doses of efavirenz (600 mg/day efavirenz orally for 17 days) to assess efavirenz mediated drug interactions."
1059635|NCT00668395|P1|Participant Flow|CYP2B6*1/*1 Genotype Group|"Efavirenz clearance following a single 600 mg oral dose of efavirenz and after multiple doses of efavirenz (600 mg/day orally for 17 days) was analyzed in normal metabolizer of CYP2B6 (CYP2B6*1/*1 genotype), intermediate metabolizer (CYP2B6*1/*6 genotype) and slow metabolizer (CYP2B6*6/*6).~During the study, the design was slightly modified to sequentially enroll instead of allocation based on specific genotype, and genotype effect was analyzed post-hoc.~The activities of CYP1A2, CYP2C9, CYP2C19, CYP3A were determined in all subjects (without regard to CYP2B6 genotype) using the metabolism of isoform selective probe substrates during the single dose (600 mg efavirenz orally) and after intake of multiple doses of efavirenz (600 mg/day efavirenz orally for 17 days) to assess efavirenz mediated drug interactions."
1059636|NCT00668395|O3|Outcome|CYP2B6*6/*6|Slow metabolizer
1059637|NCT00668395|O2|Outcome|CYP2B6*1/*6|Intermediate metabolizer
1059638|NCT00668395|O1|Outcome|CYP2B6*1/*1|Normal metabolizer
1059639|NCT00668395|E3|Reported Event|CYP2B6*6/*6|Slow metabolizer
1059640|NCT00668395|E2|Reported Event|CYP2B6*1/*6|Intermediate metabolizer
1059641|NCT00668395|E1|Reported Event|CYP2B6*1/*1|Normal metabolizer
1059642|NCT00668382|B1|Baseline|Alpha-Gal Glycosphingolipid Injection|Intervention: Intratumoral injection of a single dose of Alpha-Gal Glycosphingolipid (0.1 mg,1mg, 10mg)
1059643|NCT00668382|P1|Participant Flow|Alpha-Gal Glycosphingolipid Injection|Intervention: Intratumoral injection of a single dose of Alpha-Gal Glycosphingolipid (0.1 mg,1mg, 10mg)
1059644|NCT00668382|O1|Outcome|Intratumoral Injection|Single Intratumoral injection of Alpha Gal Glycosphingolipid. Three dose cohorts (0.1mg, 1mg, 10mg)
1059645|NCT00668382|E1|Reported Event|Intratumoral Injection|Single Intratumoral injection of Alpha Gal Glycosphingolipid. Three dose cohorts (0.1mg, 1mg, 10mg)
1059646|NCT00668317|B1|Baseline|Antacid Therapy|Therapy with omeprazole 20 mg BD and Ranitidine 300mg od nocte
1059647|NCT00668317|P1|Participant Flow|Antacid Therapy|Therapy with omeprazole 20 mg BD and Ranitidine 300mg od nocte
1059648|NCT00668317|O1|Outcome|Omeprazole and Ranitidine|Therapy with omeprazole 20 mg twice a day (BD) and Ranitidine 300mg once a day (od) at night (nocte)
1059654|NCT00668265|P1|Participant Flow|Quetiapine Arm|"The participants were scheduled to receive Quetiapine, initially at a dose of 50 mg qHS for 2 days, followed by 100 mg qHS for 2 days, and then raised to a target dose of 150 mg qHS. Patients who do not tolerate that dose were titrated downwards in 50 mg increments until a tolerable dose is achieved. Medication dosage was further adjusted as necessary during the course of the study.~Concomitant Medications:~Concomitant psychotropic medications were not allowed. Concomitant medications for treatment of physical illnesses other than those indicated in the Exclusion Criteria were allowed"
1059655|NCT00668265|O2|Outcome|Placebo Arm|The subjects in the placebo arm received inactive pills in identical blister packs
1059656|NCT00668265|O1|Outcome|Quetiapine Arm|"The participants were scheduled to receive Quetiapine, initially at a dose of 50 mg qHS for 2 days, followed by 100 mg qHS for 2 days, and then raised to a target dose of 150 mg qHS. Patients who do not tolerate that dose were titrated downwards in 50 mg increments until a tolerable dose is achieved. Medication dosage was further adjusted as necessary during the course of the study.~Concomitant Medications:~Concomitant psychotropic medications were not allowed. Concomitant medications for treatment of physical illnesses other than those indicated in the Exclusion Criteria were allowed"
1059657|NCT00668265|O2|Outcome|Placebo|
1059658|NCT00668265|O1|Outcome|Quetiapine|
1059659|NCT00668265|E2|Reported Event|Placebo|Placebo arm for subjects on MMTP in Su Casa Residence
1059660|NCT00668265|E1|Reported Event|Quetiapine|Active treatment arm for subjects on MMTP in Su Casa residence
1059661|NCT00668200|B1|Baseline|Zoledronic Acid|5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
1059662|NCT00668200|P1|Participant Flow|Zoledronic Acid|5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
1059663|NCT00668200|O1|Outcome|Zoledronic Acid|5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
1059664|NCT00668200|O1|Outcome|Zoledronic Acid|5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
1059665|NCT00668200|O1|Outcome|Zoledronic Acid|5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
1059666|NCT00668200|E1|Reported Event|Zoledronic Acid|5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
1059667|NCT00667992|B3|Baseline|Total|Total of all reporting groups
1059668|NCT00667992|B2|Baseline|Budesonide Chlorofluorocarbon (CFC) First, Then Budesonide HFA|Budesonide CFC, 100 mcg twice daily followed by Budesonide CFC 400 mcg twice daily First, then Budesonide HFA 100 mcg twice daily followed by 400 mcg twice daily.
1059669|NCT00667992|B1|Baseline|Budesonide Hydrofluoroalkane (HFA) First, Then Budesonide CFC|Budesonide Hydrofluoroalkane (HFA), 100 mcg twice daily followed by Budesonide HFA 400 mcg twice daily, First then Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily followed by Budesonide CFC 400 mcg twice daily.
1059670|NCT00667992|P2|Participant Flow|Budesonide Chlorofluorocarbon (CFC) First, Then Budesonide HFA|Budesonide CFC, 100 mcg twice daily followed by Budesonide CFC 400 mcg twice daily First, Wash out, then Budesonide HFA 100 mcg twice daily followed by 400 mcg twice daily.
1059671|NCT00667992|P1|Participant Flow|Budesonide Hydrofluoroalkane (HFA) First, Then Budesonide CFC|Budesonide Hydrofluoroalkane (HFA), 100 mcg twice daily followed by Budesonide HFA 400 mcg twice daily First, Wash out, then Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily followed by Budesonide CFC 400 mcg twice daily.
1059672|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
1059673|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
1059674|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
1059675|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane (HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
1059676|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
1059677|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon(CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
1059678|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
1059679|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane (HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
1059680|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
1059681|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks
1059682|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
1059683|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane(HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
1059684|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
1059685|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
1059686|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
1059687|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane (HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
1059688|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
1059689|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
1059690|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
1059691|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane(HFA) 100|Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks
1059692|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
1059695|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane(HFA) 100|Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks
1059696|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
1059697|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon(CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
1059698|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
1059699|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane(HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
1059700|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
1059701|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
1059702|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
1059703|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane(HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
1059704|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
1059705|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks
1059706|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
1059707|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane(HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
1059708|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
1059709|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks
1059710|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
1059711|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane(HFA) 100|Budesonide Hydrofluoroalkane(HFA) 100 mcg twice daily for 2 weeks
1059712|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
1059713|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon(CFC) 100|Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks
1059714|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
1059715|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane (HFA) 100|Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks
1059716|NCT00667992|O4|Outcome|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
1059717|NCT00667992|O3|Outcome|Budesonide Chlorofluorocarbon(CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
1059718|NCT00667992|O2|Outcome|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
1059719|NCT00667992|O1|Outcome|Budesonide Hydrofluoroalkane (HFA) 100|Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks
1059720|NCT00667992|E4|Reported Event|Budesonide CFC 400|Budesonide CFC 400 mcg twice daily for 2 weeks
1059721|NCT00667992|E3|Reported Event|Budesonide Chlorofluorocarbon (CFC) 100|Budesonide Chlorofluorocarbon (CFC) 100 mcg twice daily for 2 weeks
1059722|NCT00667992|E2|Reported Event|Budesonide HFA 400|Budesonide HFA 400 mcg twice daily for 2 weeks
1059723|NCT00667992|E1|Reported Event|Budesonide Hydrofluoroalkane (HFA) 100|Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks
1059724|NCT00667875|B4|Baseline|Total|Total of all reporting groups
1059725|NCT00667875|B3|Baseline|3 Naltrexone Plus Aripiprazole|"Naltrexone + Aripiprazole~Naltrexone + Aripiprazole : Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)"
1059726|NCT00667875|B2|Baseline|2 Naltrexone|"Naltrexone~Naltrexone : Naltrexone (25mg or 50 mg per titration schedule)"
1059727|NCT00667875|B1|Baseline|1 Placebo|Placebo : placebo
1059728|NCT00667875|P3|Participant Flow|3 Naltrexone Plus Aripiprazole|"Naltrexone + Aripiprazole~Naltrexone + Aripiprazole : Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)"
1059729|NCT00667875|P2|Participant Flow|2 Naltrexone|"Naltrexone~Naltrexone : Naltrexone (25mg or 50 mg per titration schedule)"
1059730|NCT00667875|P1|Participant Flow|1 Placebo|Placebo : placebo
1059731|NCT00667875|O3|Outcome|Naltrexone + Aripiprazole|Naltrexone + Aripiprazole: Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)
1059732|NCT00667875|O2|Outcome|Naltrexone and Inactive Placebo Aripiprazole|Naltrexone: Naltrexone (25mg or 50 mg per titration schedule)
1059733|NCT00667875|O1|Outcome|Inactive Placebo|Inactive placebo naltrexone + inactive placebo Aripiprazole
1059734|NCT00667875|E3|Reported Event|Naltrexone + Aripiprazole|Naltrexone + Aripiprazole: Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)
1059735|NCT00667875|E2|Reported Event|Naltrexone and Inactive Placebo Aripiprazole|Naltrexone: Naltrexone (25mg or 50 mg per titration schedule)
1059736|NCT00667875|E1|Reported Event|Inactive Placebo|Inactive placebo naltrexone + inactive placebo Aripiprazole
1059737|NCT00667849|B3|Baseline|Total|Total of all reporting groups
1059738|NCT00667849|B2|Baseline|Sham|"Single arm, sham (identical to active device with the exception of administration of ultrasound).~Sham: sham device identical to active device with the exception of administration of ultrasound"
1059739|NCT00667849|B1|Baseline|Exogen 4000+|"Single arm, Exogen 4000+~Low-intensity pulsed ultrasound (LIPUS)"
1059740|NCT00667849|P2|Participant Flow|Sham|"Single arm, sham (identical to active device with the exception of administration of ultrasound)~Sham: sham device identical to active device with the exception of administration of ultrasound"
1059741|NCT00667849|P1|Participant Flow|Exogen 4000+|"Single arm, Exogen 4000+~Low-intensity pulsed ultrasound (LIPUS)"
1059742|NCT00667849|O2|Outcome|Sham|"Single arm, sham (identical to active device with the exception of administration of ultrasound)~sham: sham device identical to active device with the exception of administration of ultrasound"
1059743|NCT00667849|O1|Outcome|Exogen 4000+|"Single arm, Exogen 4000+~Low-intensity pulsed ultrasound (LIPUS)"
1059744|NCT00667849|O2|Outcome|Sham|"Single arm, sham (identical to active device with the exception of administration of ultrasound)~Sham: device identical to active device with the exception of administration of ultrasound"
1059745|NCT00667849|O1|Outcome|Exogen 4000+|Single arm, active Exogen 4000+ Low-intensity pulsed ultrasound (LIPUS)
1059746|NCT00667849|O2|Outcome|Sham|Single arm, sham (identical to active device with the exception of administration of ultrasound)
1069716|NCT00639223|P1|Participant Flow|Pravastatin|
1059747|NCT00667849|O1|Outcome|Exogen 4000+|Single arm, active Exogen 4000+ Low-intensity pulsed ultrasound (LIPUS)
1059748|NCT00667849|E2|Reported Event|Sham|"Single arm, sham (identical to active device with the exception of administration of ultrasound)~Sham: device identical to active device with the exception of administration of ultrasound"
1059749|NCT00667849|E1|Reported Event|Exogen 4000+|"Single arm, active Exogen 4000+ ultrasound bone healing system~Low-intensity pulsed ultrasound (LIPUS)"
1059750|NCT00667810|B5|Baseline|Total|Total of all reporting groups
1059751|NCT00667810|B4|Baseline|Bapineuzumab 2.0 mg/kg|Participants received 2.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059752|NCT00667810|B3|Baseline|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059753|NCT00667810|B2|Baseline|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059754|NCT00667810|B1|Baseline|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059755|NCT00667810|P4|Participant Flow|Bapineuzumab 2.0 mg/kg|Participants received 2.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059756|NCT00667810|P3|Participant Flow|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059757|NCT00667810|P2|Participant Flow|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059758|NCT00667810|P1|Participant Flow|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by intravenous (IV) infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059759|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059760|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059761|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059762|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059763|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059764|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059765|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059766|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059767|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059768|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059769|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059770|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059771|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059772|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059773|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059774|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059775|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1060164|NCT00667342|O2|Outcome|C: Metastatic Tumors|Stratum C participants had metastatic tumors.
1059776|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059777|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059778|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059779|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059780|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059781|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059782|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059783|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059784|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059785|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059786|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059787|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059788|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059789|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg - Placebo|For the DAD total score, results are presented from a REML)-based MMRM.
1059790|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg - Placebo|For the DAD total score, results are presented from a REML-based MMRM.
1059791|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg - Placebo|For the ADAS-Cog/11 total score, results are presented from a REML based MMRM.
1059792|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg - Placebo|For the ADAS-Cog/11 total score, results are presented from a REML based MMRM.
1059793|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059794|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059795|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059796|NCT00667810|O4|Outcome|Pooled Bapineuzumab 0.5/1.0 mg/kg|Participants in the bapineuzumab 0.5 and 1.0 mg/kg groups were combined
1059797|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059798|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059799|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059800|NCT00667810|O4|Outcome|Pooled Bapineuzumab 0.5/1.0 mg/kg|Participants in the bapineuzumab 0.5 and 1.0 mg/kg groups were combined to form the Pooled Bapineuzumab group.
1059801|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059802|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059803|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059804|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059805|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1069717|NCT00639223|O2|Outcome|Red Yeast Rice|
1059806|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059807|NCT00667810|O3|Outcome|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059808|NCT00667810|O2|Outcome|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059809|NCT00667810|O1|Outcome|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059810|NCT00667810|E4|Reported Event|Bapineuzumab 2.0 mg/kg|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059811|NCT00667810|E3|Reported Event|Placebo|Participants received placebo by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059812|NCT00667810|E2|Reported Event|Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059813|NCT00667810|E1|Reported Event|Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab by IV infusion every 13 weeks, for a total of 6 infusions over the course of the study. A final follow-up visit was performed at Week 78, 13 weeks after the last infusion.
1059814|NCT00667745|B3|Baseline|Total|Total of all reporting groups
1059815|NCT00667745|B2|Baseline|OPT Without Lithium|"Participants only received optimized medication treatment, as needed; lithium was not be used.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
1059816|NCT00667745|B1|Baseline|OPT With Lithium|"Participants received lithium plus optimized medication treatment, as needed.~Lithium Carbonate : Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
1059817|NCT00667745|P2|Participant Flow|OPT Without Lithium|"Participants only received optimized medication treatment, as needed; lithium was not be used.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
1059818|NCT00667745|P1|Participant Flow|OPT With Lithium|"Participants received lithium plus optimized medication treatment, as needed.~Lithium Carbonate : Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
1059819|NCT00667745|O2|Outcome|OPT Without Lithium|"Participants only received optimized medication treatment, as needed; lithium was not be used.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
1059820|NCT00667745|O1|Outcome|OPT With Lithium|"Participants received lithium plus optimized medication treatment, as needed.~Lithium Carbonate : Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
1059821|NCT00667745|O2|Outcome|OPT Without Lithium|"Participants only received optimized medication treatment, as needed; lithium was not be used.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
1059822|NCT00667745|O1|Outcome|OPT With Lithium|"Participants received lithium plus optimized medication treatment, as needed.~Lithium Carbonate : Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
1059823|NCT00667745|E2|Reported Event|OPT Without Lithium|"Participants only received optimized medication treatment, as needed; lithium was not be used.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
1059824|NCT00667745|E1|Reported Event|OPT With Lithium|"Participants received lithium plus optimized medication treatment, as needed.~Lithium Carbonate : Lithium was started at 300 mg and then increased to 600 mg after 3 days. Lithium doses were maintained at 600 mg per day for 8 weeks, but may have been adjusted after that time as needed up to a serum level of 1.2 mEq/L.~Optimized Treatment (OPT) : The foundation of OPT was to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines."
1059825|NCT00667732|B3|Baseline|Total|Total of all reporting groups
1059826|NCT00667732|B2|Baseline|Placebo Group|"Participants will receive placebo rather than exenatide as part of their diabetes treatment~placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks"
1059827|NCT00667732|B1|Baseline|Exenatide Group|"Participants will receive exenatide as part of their diabetes treatment~exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks"
1059828|NCT00667732|P3|Participant Flow|Placebo Group|"After run-in participants were randomized to placebo.~placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks~metformin: continued at same dose participant entered study on.~Lantus Insulin: titrated per protocol depending on blood sugar levels~In extension period, participants continued regular regimen with open label exenatide instead of placebo"
1059829|NCT00667732|P2|Participant Flow|Exenatide Group|"After run-in participants were randomized to exenatide.~exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks~metformin: continued at same dose participant entered study on.~Lantus Insulin: titrated per protocol depending on blood sugar levels~In extension period, participants continued regular regimen with open label exenatide"
1059830|NCT00667732|P1|Participant Flow|Run-In Group|"All participants took exenatide twice daily in addition to their Metformin dose.~A subset of participants agreed to a substudy (20 pts) and had a glucose and metabolic profile done at this time."
1059831|NCT00667732|O2|Outcome|Placebo Group|
1059832|NCT00667732|O1|Outcome|Exenatide Group|"Participants will receive exenatide as part of their diabetes treatment~exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks"
1059833|NCT00667732|O2|Outcome|Placebo Group|"Participants will receive placebo rather than exenatide as part of their diabetes treatment~placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks"
1059834|NCT00667732|O1|Outcome|Exenatide Group|"Participants will receive exenatide as part of their diabetes treatment~exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks"
1059835|NCT00667732|E5|Reported Event|Exenatide Open-Label (Previous Placebo)|Participants who were in the Placebo Arm during randomization who received open label: exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar level
1059836|NCT00667732|E4|Reported Event|Exenatide Open-Label (Previous Exenatide)|Participants who were in the Exenatide Arm during randomization who received open label: exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar level
1059837|NCT00667732|E3|Reported Event|Placebo Randomization Period|After run-in participants were randomized to placebo. placebo : 5mcg twice a day, increased to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar levels
1059838|NCT00667732|E2|Reported Event|Exenatide Randomization Group|After run-in participants were randomized to exenatide. exenatide : 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks metformin: continued at same dose participant entered study on. Lantus Insulin: titrated per protocol depending on blood sugar levels
1059839|NCT00667732|E1|Reported Event|Run-In Group|All participants took exenatide twice daily in addition to their Metformin dose.
1059840|NCT00667693|B3|Baseline|Total|Total of all reporting groups
1059841|NCT00667693|B2|Baseline|Pentax|"intubation with a the Pentax AWS~Pentax AWS: Intubation with Pentax AWS"
1059842|NCT00667693|B1|Baseline|Macintosh|"Intubation with a Macintosh laryngoscope~Macintosh intubation: Macintosh intubation"
1059843|NCT00667693|P2|Participant Flow|Pentax|"intubation with a the Pentax AWS~Pentax AWS: Intubation with Pentax AWS"
1059844|NCT00667693|P1|Participant Flow|Macintosh|"Intubation with a Macintosh laryngoscope~Macintosh intubation: Macintosh intubation"
1059845|NCT00667693|O2|Outcome|Pentax|"intubation with a the Pentax AWS~Pentax AWS: Intubation with Pentax AWS"
1059846|NCT00667693|O1|Outcome|Macintosh|"Intubation with a Macintosh laryngoscope~Macintosh intubation: Macintosh intubation"
1059847|NCT00667693|E2|Reported Event|Pentax|"intubation with a the Pentax AWS~Pentax AWS: Intubation with Pentax AWS"
1059848|NCT00667693|E1|Reported Event|Macintosh|"Intubation with a Macintosh laryngoscope~Macintosh intubation: Macintosh intubation"
1059849|NCT00667602|B4|Baseline|Total|Total of all reporting groups
1059850|NCT00667602|B3|Baseline|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059851|NCT00667602|B2|Baseline|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059852|NCT00667602|B1|Baseline|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059853|NCT00667602|P3|Participant Flow|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059854|NCT00667602|P2|Participant Flow|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059855|NCT00667602|P1|Participant Flow|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059856|NCT00667602|O3|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059857|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059858|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059859|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059860|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059861|NCT00667602|O3|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059862|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059863|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059864|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059865|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059866|NCT00667602|O3|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059867|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059868|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059869|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059870|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059871|NCT00667602|O3|Outcome|MenC(1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059872|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059873|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059874|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059875|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059876|NCT00667602|O3|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059877|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059878|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059879|NCT00667602|O3|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059880|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059881|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059882|NCT00667602|O3|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059883|NCT00667602|O2|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and concomitant dose of PCV7 and DTPa-IPV-HepBHib at 12 months.
1059884|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059885|NCT00667602|O2|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059886|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059887|NCT00667602|O1|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059888|NCT00667602|O2|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059889|NCT00667602|O1|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059890|NCT00667602|O1|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059891|NCT00667602|O2|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059892|NCT00667602|O1|Outcome|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059893|NCT00667602|O2|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059894|NCT00667602|O1|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059895|NCT00667602|O2|Outcome|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059896|NCT00667602|O1|Outcome|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059897|NCT00667602|E3|Reported Event|MenC (1dose) + Concomitant Vaccines|Infants received one dose of MenC vaccine at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059898|NCT00667602|E2|Reported Event|MenACWY-CRM197 (1dose) + Concomitant Vaccines|Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059899|NCT00667602|E1|Reported Event|MenACWY-CRM197 (2dose) + Concomitant Vaccines|Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
1059900|NCT00667589|B5|Baseline|Total|Total of all reporting groups
1059901|NCT00667589|B4|Baseline|Urea 40% Cream|urea 40% cream applied twice per day to affected areas
1059902|NCT00667589|B3|Baseline|Tazarotene 0.1% Cream|tazarotene 0.1% cream applied twice per day to affected areas
1059903|NCT00667589|B2|Baseline|Udderly Smooth® Emollient|emollient applied twice per day to affected areas
1059904|NCT00667589|B1|Baseline|Fluocinonide 0.05% Cream|fluocinonide 0.05% cream applied twice per day to affected areas
1059905|NCT00667589|P4|Participant Flow|Urea 40% Cream|urea 40% cream applied twice per day to affected areas
1059906|NCT00667589|P3|Participant Flow|Tazarotene 0.1% Cream|tazarotene 0.1% cream applied twice per day to affected areas
1059907|NCT00667589|P2|Participant Flow|Udderly Smooth® Emollient|emollient applied twice per day to affected areas
1059908|NCT00667589|P1|Participant Flow|Fluocinonide 0.05% Cream|fluocinonide 0.05% cream applied twice per day to affected areas
1059909|NCT00667589|O3|Outcome|Urea 40% Cream|urea 40% cream applied twice per day to affected areas
1059910|NCT00667589|O2|Outcome|Tazarotene 0.1% Cream|tazarotene 0.1% cream applied twice per day to affected areas
1059911|NCT00667589|O1|Outcome|Fluocinonide 0.05% Cream|fluocinonide 0.05% cream applied twice per day to affected areas
1059912|NCT00667589|O1|Outcome|Urea 40% Cream|urea 40% cream applied twice per day to affected areas
1059913|NCT00667589|E4|Reported Event|Urea 40% Cream|urea 40% cream applied twice per day to affected areas
1059914|NCT00667589|E3|Reported Event|Tazarotene 0.1% Cream|tazarotene 0.1% cream applied twice per day to affected areas
1059915|NCT00667589|E2|Reported Event|Udderly Smooth® Emollient|emollient applied twice per day to affected areas
1059916|NCT00667589|E1|Reported Event|Fluocinonide 0.05% Cream|fluocinonide 0.05% cream applied twice per day to affected areas
1059917|NCT00667576|B6|Baseline|Total|Total of all reporting groups
1059918|NCT00667576|B5|Baseline|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
1059919|NCT00667576|B4|Baseline|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
1059920|NCT00667576|B3|Baseline|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
1059921|NCT00667576|B2|Baseline|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
1059922|NCT00667576|B1|Baseline|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
1059923|NCT00667576|P5|Participant Flow|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
1059924|NCT00667576|P4|Participant Flow|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
1059925|NCT00667576|P3|Participant Flow|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
1059926|NCT00667576|P2|Participant Flow|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
1059927|NCT00667576|P1|Participant Flow|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
1059928|NCT00667576|O5|Outcome|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
1059929|NCT00667576|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
1059930|NCT00667576|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
1059931|NCT00667576|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
1059932|NCT00667576|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
1059933|NCT00667576|O5|Outcome|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
1059934|NCT00667576|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
1059935|NCT00667576|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
1059936|NCT00667576|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
1059937|NCT00667576|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
1059938|NCT00667576|O5|Outcome|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
1059939|NCT00667576|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
1060251|NCT00666965|P2|Participant Flow|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
1059940|NCT00667576|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
1059941|NCT00667576|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
1059942|NCT00667576|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
1059943|NCT00667576|O5|Outcome|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
1059944|NCT00667576|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
1059945|NCT00667576|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
1059946|NCT00667576|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
1059947|NCT00667576|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
1059948|NCT00667576|O5|Outcome|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
1059949|NCT00667576|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
1059950|NCT00667576|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
1059951|NCT00667576|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
1059952|NCT00667576|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
1059953|NCT00667576|O5|Outcome|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
1059954|NCT00667576|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
1059955|NCT00667576|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
1059956|NCT00667576|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
1059957|NCT00667576|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
1059958|NCT00667576|O5|Outcome|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
1059959|NCT00667576|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
1059960|NCT00667576|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
1059961|NCT00667576|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
1059962|NCT00667576|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
1059963|NCT00667576|O5|Outcome|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
1059964|NCT00667576|O4|Outcome|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
1059965|NCT00667576|O3|Outcome|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
1059966|NCT00667576|O2|Outcome|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
1059967|NCT00667576|O1|Outcome|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
1059968|NCT00667576|E5|Reported Event|Maxacalcitol 5 or 10 µg ± 2.5 µg|Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
1059969|NCT00667576|E4|Reported Event|Paricalcitol 4 µg ± 2 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
1059970|NCT00667576|E3|Reported Event|Paricalcitol 4 µg ± 1 µg|Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
1059971|NCT00667576|E2|Reported Event|Paricalcitol 2 µg ± 2 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg
1059972|NCT00667576|E1|Reported Event|Paricalcitol 2 µg ± 1 µg|Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
1059973|NCT00667563|B1|Baseline|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
1059974|NCT00667563|P1|Participant Flow|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
1059975|NCT00667563|O1|Outcome|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
1059976|NCT00667563|O1|Outcome|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
1069718|NCT00639223|O1|Outcome|Pravastatin|
1059977|NCT00667563|O1|Outcome|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
1059978|NCT00667563|O1|Outcome|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
1059979|NCT00667563|O1|Outcome|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
1059980|NCT00667563|O1|Outcome|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
1059981|NCT00667563|O1|Outcome|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
1059982|NCT00667563|E1|Reported Event|Gardasil Vaccination|"Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.~DNA analysis: Weeks 0, 2, 10, 26, and 52.~polymerase chain reaction: Screening, week 36, and week 52.~cytology specimen collection procedure: Screening, week 36, and week 52.~colposcopic biopsy: Screening, week 36, and week 52."
1059983|NCT00667511|B1|Baseline|Home Short Daily Hemodialysis Then Home Nocturnal Hemodialysis|"Intervention 1: Patients performed short daily hemodialysis (DHD) (2 to 4 hour treatments) in the home setting using the NxStage System One for an 8 week period.~Intervention 2: Patients completing Intervention 1 and successfully completing a 4 week training/transition period proceeded to perform nocturnal hemodialysis (NHD) (6 to 10 hour treatments) in the home setting using the NxStage System One for an 8 week period."
1059984|NCT00667511|P1|Participant Flow|Home Short Daily Hemodialysis Then Home Nocturnal Hemodialysis|"Intervention 1: Patients performed short daily hemodialysis (DHD) (2 to 4 hour treatments) in the home setting using the NxStage System One for an 8 week period.~Intervention 2: Patients completing Intervention 1 and successfully completing a 4 week training/transition period proceeded to perform nocturnal hemodialysis (NHD) (6 to 10 hour treatments) in the home setting using the NxStage System One for an 8 week period.~In this prospective, two treatment, cross-over study, 58 End Stage Renal Disease patients >18 years of age who were currently stable on home DHD were enrolled. Enrolled patients performed Intervention 1 as the first phase of the cross-over study. Fifty-one patients completed Intervention 1 and seven patients dropped out. Forty-three patients completed the training/transition period and performed Intervention 2 as the second phase of the cross-over study. Thirty-nine patients completed Intervention 2 and four patients dropped out."
1059985|NCT00667511|O2|Outcome|Home Nocturnal Hemodialysis|Intervention 2: Patients perform nocturnal hemodialysis (6 to 10 hour treatments) in the home setting using the NxStage System One.
1059986|NCT00667511|O1|Outcome|Home Short Daily Hemodialysis|Intervention 1: Patients perform short daily hemodialysis (2 to 4 hour treatments) in the home setting using the NxStage System One.
1059987|NCT00667511|O2|Outcome|Home Nocturnal Hemodialysis|Intervention 2: Patients perform nocturnal hemodialysis (6 to 10 hour treatments) in the home setting using the NxStage System One.
1059988|NCT00667511|O1|Outcome|Home Short Daily Hemodialysis|Intervention 1: Patients perform short daily hemodialysis (2 to 4 hour treatments) in the home setting using the NxStage System One.
1059989|NCT00667511|E2|Reported Event|Nocturnal Home Hemodialysis|Intervention 2: Patients perform nocturnal hemodialysis (6 to 10 hour treatments) in the home setting using the NxStage System One.
1059990|NCT00667511|E1|Reported Event|Home Short Daily Hemodialysis|Intervention 1: Patients perform short daily hemodialysis (2 to 4 hour treatments) in the home setting using the NxStage System One.
1059991|NCT00667459|B3|Baseline|Total|Total of all reporting groups
1059992|NCT00667459|B2|Baseline|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
1059993|NCT00667459|B1|Baseline|Investigational|PRESTIGE® LP Cervical Disc
1059994|NCT00667459|P2|Participant Flow|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876)
1059995|NCT00667459|P1|Participant Flow|Investigational|PRESTIGE® LP Cervical Disc
1059996|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
1059997|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
1060252|NCT00666965|P1|Participant Flow|Placebo|placebo transdermal patch
1059998|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
1059999|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
1060000|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
1060001|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
1060002|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
1060003|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
1060004|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
1060005|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
1060006|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
1060007|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
1060008|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
1060009|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
1060010|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
1060011|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
1060012|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
1060013|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
1060014|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
1060015|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
1060016|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
1060017|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
1060018|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
1060019|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
1060020|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
1060021|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
1060022|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
1060023|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
1060024|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
1060025|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
1060026|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
1060027|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
1060028|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
1060029|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
1060030|NCT00667459|O2|Outcome|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
1060031|NCT00667459|O1|Outcome|Investigational|PRESTIGE® LP Cervical Disc
1060032|NCT00667459|E2|Reported Event|Control|Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
1060033|NCT00667459|E1|Reported Event|Investigational|PRESTIGE® LP Cervical Disc
1060034|NCT00667446|B3|Baseline|Total|Total of all reporting groups
1060035|NCT00667446|B2|Baseline|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
1060036|NCT00667446|B1|Baseline|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
1060037|NCT00667446|P2|Participant Flow|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart during the Treatment Period. During the the Safety Follow-Up Period participants were offered standard of care treatment as deemed appropriate by the investigator.
1060038|NCT00667446|P1|Participant Flow|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart during the Treatment Period. During the Safety Follow-Up Period participants were offered standard of care treatment as deemed appropriate by the investigator.
1060039|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
1060040|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
1060041|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
1060042|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
1060043|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
1060044|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
1060045|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
1060046|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
1060047|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
1060048|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
1060163|NCT00667342|O1|Outcome|All Participants|All the 42 evaluable participants in this study had osteosarcoma, of which 22 had events and 20 had no event.
1060049|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
1060050|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
1060051|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
1060052|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
1060053|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
1060054|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
1060055|NCT00667446|O2|Outcome|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
1060056|NCT00667446|O1|Outcome|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
1060057|NCT00667446|E2|Reported Event|Leuprolide Acetate 3M Depot 30 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.
1060058|NCT00667446|E1|Reported Event|Leuprolide Acetate 3M Depot 11.25 mg|Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.
1060059|NCT00667420|B1|Baseline|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
1060060|NCT00667420|P1|Participant Flow|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
1060061|NCT00667420|O1|Outcome|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin, and Capecitabine (EOX-P) Chemotherapy.
1060062|NCT00667420|O1|Outcome|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin, and Capecitabine (EOX-P) Chemotherapy.
1060063|NCT00667420|O1|Outcome|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
1060064|NCT00667420|O1|Outcome|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin, and Capecitabine (EOX-P) Chemotherapy.
1060065|NCT00667420|O1|Outcome|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
1060066|NCT00667420|E1|Reported Event|Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment|Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
1060067|NCT00667394|B3|Baseline|Total|Total of all reporting groups
1060068|NCT00667394|B2|Baseline|Tandutinib & Bevacizumab in AG Patients|AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
1060069|NCT00667394|B1|Baseline|Tandutinib & Bevacizumab in GBM Patients|GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
1060070|NCT00667394|P2|Participant Flow|Tandutinib & Bevacizumab in AG Patients|AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
1060071|NCT00667394|P1|Participant Flow|Tandutinib & Bevacizumab in GBM Patients|GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
1060072|NCT00667394|O2|Outcome|Tandutinib & Bevacizumab in AG Patients|AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
1060073|NCT00667394|O1|Outcome|Tandutinib & Bevacizumab in GBM Patients|GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
1060074|NCT00667394|O2|Outcome|Tandutinib & Bevacizumab in AG Patients|AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
1060075|NCT00667394|O1|Outcome|Tandutinib & Bevacizumab in GBM Patients|GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
1060076|NCT00667394|E2|Reported Event|Tandutinib & Bevacizumab in AG Patients|AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
1060077|NCT00667394|E1|Reported Event|Tandutinib & Bevacizumab in GBM Patients|GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
1060078|NCT00667381|B3|Baseline|Total|Total of all reporting groups
1060079|NCT00667381|B2|Baseline|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
1060080|NCT00667381|B1|Baseline|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
1060081|NCT00667381|P2|Participant Flow|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
1060082|NCT00667381|P1|Participant Flow|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
1060083|NCT00667381|O2|Outcome|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
1060084|NCT00667381|O1|Outcome|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
1060085|NCT00667381|O2|Outcome|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
1060086|NCT00667381|O1|Outcome|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
1060087|NCT00667381|O2|Outcome|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
1060088|NCT00667381|O1|Outcome|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
1060089|NCT00667381|O2|Outcome|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
1060090|NCT00667381|O1|Outcome|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
1060091|NCT00667381|O2|Outcome|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
1060092|NCT00667381|O1|Outcome|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
1060093|NCT00667381|E2|Reported Event|Ultrasound|Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
1060094|NCT00667381|E1|Reported Event|Control|The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
1060095|NCT00667368|B3|Baseline|Total|Total of all reporting groups
1060096|NCT00667368|B2|Baseline|Intervention|"Metronidazole 500mg twice daily for 7 days for Bacterial Vaginosis (BV) detection~Metronidazole: Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days."
1060097|NCT00667368|B1|Baseline|Control|Bi-monthly testing for BV without treatment.
1060098|NCT00667368|P2|Participant Flow|Intervention|"Metronidazole 500mg twice daily for 7 days for Bacterial Vaginosis (BV) detection~Metronidazole: Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days."
1060099|NCT00667368|P1|Participant Flow|Control|Bi-monthly testing for BV without treatment.
1060100|NCT00667368|O2|Outcome|Intervention|"Metronidazole 500mg twice daily for 7 days for Bacterial Vaginosis (BV) detection~Metronidazole: Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days."
1060101|NCT00667368|O1|Outcome|Control|Bi-monthly testing for BV without treatment.
1060102|NCT00667368|O2|Outcome|Intervention|"Metronidazole 500mg twice daily for 7 days for Bacterial Vaginosis (BV) detection~Metronidazole: Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days."
1060103|NCT00667368|O1|Outcome|Control|Bi-monthly testing for BV without treatment.
1060104|NCT00667368|E2|Reported Event|Intervention|"Metronidazole 500mg twice daily for 7 days for Bacterial Vaginosis (BV) detection~Metronidazole: Bi-monthly testing and treatment for BV with Metronidazole if BV is detected; 500mg twice daily for 7 days."
1060105|NCT00667368|E1|Reported Event|Control|Bi-monthly testing for BV without treatment.
1060106|NCT00667355|B1|Baseline|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
1060107|NCT00667355|P1|Participant Flow|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
1060108|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
1060109|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
1060110|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
1060111|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
1060112|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
1060113|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
1060114|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
1060115|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
1060116|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
1060117|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
1060118|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
1060119|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
1060120|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
1060121|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
1060122|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
1060123|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
1060124|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
1060125|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
1060126|NCT00667355|O1|Outcome|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
1060127|NCT00667355|E1|Reported Event|Adalimumab|Adalimumab 40 mg or 80 mg subcutaneously administered every other week until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan.
1060128|NCT00667342|B4|Baseline|Total|Total of all reporting groups
1060129|NCT00667342|B3|Baseline|C: Metastatic Tumors|Stratum C participants had metastatic tumors.
1060130|NCT00667342|B2|Baseline|B: Localized Unresectable Disease|Participants with localized unresectable primary tumors were to participate in Stratum B. No participants were enrolled to this stratum.
1060131|NCT00667342|B1|Baseline|A: Localized Resectable Disease|Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
1060132|NCT00667342|P3|Participant Flow|C: Metastatic Tumors|Stratum C participants had metastatic tumors.
1060133|NCT00667342|P2|Participant Flow|B: Localized Unresectable Disease|Participants with localized unresectable primary tumors were to participate in Stratum B. No participants were enrolled to this stratum.
1060134|NCT00667342|P1|Participant Flow|A: Localized Resectable Disease|Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
1060135|NCT00667342|O3|Outcome|Entire Study Group|Participants enrolled on the study who met the criteria for evaluation of neuropathic pain.
1060136|NCT00667342|O2|Outcome|Limb Sparing Group|Participants had localized disease at diagnosis. One participant had 2 surgeries.
1060137|NCT00667342|O1|Outcome|Amputation Group|Participants had metastatic disease at diagnosis.
1060138|NCT00667342|O3|Outcome|Entire Study Group|Participants enrolled on the study who met the criteria for evaluation of neuropathic pain.
1060139|NCT00667342|O2|Outcome|Limb Sparing Group|Participants had localized disease at diagnosis. One participant had 2 surgeries.
1060140|NCT00667342|O1|Outcome|Amputation Group|Participants had metastatic disease at diagnosis.
1060141|NCT00667342|O3|Outcome|Entire Study Group|Participants enrolled on the study who met the criteria for evaluation of neuropathic pain.
1060142|NCT00667342|O2|Outcome|Limb Sparing Group|Participants had localized disease at diagnosis. One participant had 2 surgeries.
1060143|NCT00667342|O1|Outcome|Amputation Group|Participants had metastatic disease at diagnosis.
1060144|NCT00667342|O3|Outcome|Entire Study Group|Participants enrolled on the study who met the criteria for evaluation of neuropathic pain.
1060145|NCT00667342|O2|Outcome|Limb Sparing Group|Participants had localized disease at diagnosis. One participant had 2 surgeries.
1060146|NCT00667342|O1|Outcome|Amputation Group|Participants had metastatic disease at diagnosis.
1060147|NCT00667342|O3|Outcome|Entire Study Group|Participants enrolled on the study who met the criteria for evaluation of neuropathic pain.
1060148|NCT00667342|O2|Outcome|Limb Sparing Group|Participants had localized disease at diagnosis. One participant had 2 surgeries.
1060149|NCT00667342|O1|Outcome|Amputation Group|Participants had metastatic disease at diagnosis.
1060150|NCT00667342|O1|Outcome|All Participants|Thirty-two participants with osteosarcoma were evaluated in this study. The analysis for this outcome measure included 23 Stratum A participants who had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis, and 8 Stratum C participants who had metastatic tumors.
1060151|NCT00667342|O1|Outcome|All Participants|All 42 evaluable participants in this study had osteosarcoma. This analysis includes 29 Stratum A participants who had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis, and 11 Stratum C participants who had metastatic tumors.
1060152|NCT00667342|O1|Outcome|All Participants|All 42 evaluable participants in this study had osteosarcoma. This analysis includes 29 Stratum A participants who had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis, and 11 Stratum C participants who had metastatic tumors.
1060153|NCT00667342|O1|Outcome|All Participants|All 42 evaluable participants in this study had osteosarcoma. This analysis includes 29 Stratum A participants who had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis, and 11 Stratum C participants who had metastatic tumors.
1060154|NCT00667342|O2|Outcome|C: Metastatic Tumors|Stratum C participants had metastatic tumors.
1060155|NCT00667342|O1|Outcome|A: Localized Resectable Disease|Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
1060156|NCT00667342|O2|Outcome|C: Metastatic Tumors|Stratum C participants had metastatic tumors.
1060157|NCT00667342|O1|Outcome|A: Localized Resectable Disease|Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
1060158|NCT00667342|O2|Outcome|C: Metastatic Tumors|Stratum C participants had metastatic tumors.
1060159|NCT00667342|O1|Outcome|A: Localized Resectable Disease|Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
1060160|NCT00667342|O1|Outcome|A: Localized Resectable Disease|OS2008 Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
1060161|NCT00667342|O1|Outcome|A: Localized Resectable Disease|OS2008 Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
1060162|NCT00667342|O1|Outcome|All Participants|All 42 evaluable participants were included in this analysis
1060165|NCT00667342|O1|Outcome|A: Localized Resectable Disease|Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
1060166|NCT00667342|O1|Outcome|A: Localized Resectable Disease|OS2008 Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
1060167|NCT00667342|O2|Outcome|C: Metastatic Tumors|Stratum C participants had metastatic tumors.
1060168|NCT00667342|O1|Outcome|A: Localized Resectable Disease|Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
1060169|NCT00667342|E2|Reported Event|C: Metastatic Tumors|Stratum C participants had metastatic tumors.
1060170|NCT00667342|E1|Reported Event|A: Localized Resectable Disease|Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
1060171|NCT00667277|B1|Baseline|Bevacizumab (Avastin)|"Use of bevacizumab (Avastin) in the treatment of myelofibrosis.~bevacizumab (Avastin): 15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)"
1060172|NCT00667277|P1|Participant Flow|Bevacizumab (Avastin)|"Use of bevacizumab (Avastin) in the treatment of myelofibrosis.~bevacizumab (Avastin): 15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)"
1060173|NCT00667277|O1|Outcome|Bevacizumab (Avastin)|"Use of bevacizumab (Avastin) in the treatment of myelofibrosis.~bevacizumab (Avastin): 15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)"
1060174|NCT00667277|O1|Outcome|Bevacizumab (Avastin)|"Use of bevacizumab (Avastin) in the treatment of myelofibrosis.~bevacizumab (Avastin): 15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)"
1060175|NCT00667277|E1|Reported Event|Bevacizumab (Avastin)|"Use of bevacizumab (Avastin) in the treatment of myelofibrosis.~bevacizumab (Avastin): 15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)"
1060176|NCT00667251|B3|Baseline|Total|Total of all reporting groups
1060177|NCT00667251|B2|Baseline|Trastuzumab|
1060178|NCT00667251|B1|Baseline|Lapatinib|
1060179|NCT00667251|P2|Participant Flow|Trastuzumab|Trastuzumab ng- IV weekly (loading dose 4 mg/kg, subsequent doses 2 mg/kg) Paclitaxel - 80 mg/m2 IV weekly (days 1, 8 and 15 of a 4-week cycle). or Trastuzumab - IV weekly (loading dose 8 mg/kg, subsequent doses 6 mg/kg) Docetaxel - 75 mg/m2 IV q 3 weekly (day 1 of a 3 week cycle) Followed by: Trastuzumab - 6 mg/kg IV q 3 weekly until disease progression.
1060180|NCT00667251|P1|Participant Flow|Lapatinib|Lapatinib - 1250 mg po daily Taxane based chemotherapy: Paclitaxel - 80 mg/m2 IV q weekly (days 1, 8 and 15 of a 4-week cycle) or Docetaxel - 75 mg/m2 IV q 3 weekly (day 1 of a 3-week cycle) plus G-CSF - according to institutional standards. Followed by: Lapatinib - 1500 mg po daily until disease progression.
1060181|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
1060182|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
1060183|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
1060184|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
1060185|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
1060186|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
1060187|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
1060188|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
1060189|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
1060190|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
1060191|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
1060192|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
1060193|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
1060194|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
1060195|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
1060196|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
1060197|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
1060198|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
1060199|NCT00667251|O2|Outcome|Trastuzumab|Plus taxane based chemotherapy.
1060200|NCT00667251|O1|Outcome|Lapatinib|Plus taxane based chemotherapy
1060201|NCT00667251|E2|Reported Event|Trastuzumab|Plus taxane based chemotherapy.
1060202|NCT00667251|E1|Reported Event|Lapatinib|Plus taxane based chemotherapy
1060203|NCT00667225|B3|Baseline|Total|Total of all reporting groups
1060204|NCT00667225|B2|Baseline|Cantharidin|Subjects in this group will have topical application of cantharidin at each visit. Cantharidin will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
1060205|NCT00667225|B1|Baseline|Vehicle|Subjects in this group will have topical application of cantharidin's vehicle at each visit. Vehicle will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
1060206|NCT00667225|P2|Participant Flow|Cantharidin|Subjects in this group will have topical application of cantharidin at each visit. Cantharidin will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
1060253|NCT00666965|O4|Outcome|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
1060254|NCT00666965|O3|Outcome|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
1060255|NCT00666965|O2|Outcome|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
1060207|NCT00667225|P1|Participant Flow|Vehicle|Subjects in this group will have topical application of cantharidin's vehicle at each visit. Vehicle will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
1060208|NCT00667225|O2|Outcome|Cantharidin|Subjects in this group will have topical application of cantharidin at each visit. Cantharidin will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
1060209|NCT00667225|O1|Outcome|Vehicle|Subjects in this group will have topical application of cantharidin's vehicle at each visit. Vehicle will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
1060210|NCT00667225|O2|Outcome|Cantharidin|Subjects in this group will have topical application of cantharidin at each visit. Cantharidin will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
1060211|NCT00667225|O1|Outcome|Vehicle|Subjects in this group will have topical application of cantharidin's vehicle at each visit. Vehicle will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
1060212|NCT00667225|E2|Reported Event|Cantharidin|Subjects in this group will have topical application of cantharidin at each visit. Cantharidin will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
1060213|NCT00667225|E1|Reported Event|Vehicle|Subjects in this group will have topical application of cantharidin's vehicle at each visit. Vehicle will be applied every two weeks for a total of 5 visits (4 applications, one follow up visit, for a total of 8 weeks). The solution is applied topically with the stick end of a cotton tipped applicator to the lesion with care to avoid normal skin. Up to 2 lesions were treated on the first visit, and up to 20 lesions were treated on subsequent visits. Parents were instructed to wash the area 4 hours after application.
1060214|NCT00667186|B3|Baseline|Total|Total of all reporting groups
1060215|NCT00667186|B2|Baseline|Targeted Screening|"Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
1060216|NCT00667186|B1|Baseline|Routine Screening|"Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
1060217|NCT00667186|P2|Participant Flow|Targeted Screening|"Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
1060218|NCT00667186|P1|Participant Flow|Routine Screening|"Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
1060219|NCT00667186|O2|Outcome|Targeted Screening|"Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
1060220|NCT00667186|O1|Outcome|Routine Screening|"Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
1060221|NCT00667186|O2|Outcome|Targeted Screening|"Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
1060222|NCT00667186|O1|Outcome|Routine Screening|"Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
1060223|NCT00667186|E2|Reported Event|Targeted Screening|"Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
1060224|NCT00667186|E1|Reported Event|Routine Screening|"Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria~Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk"
1060225|NCT00667095|B3|Baseline|Total|Total of all reporting groups
1060226|NCT00667095|B2|Baseline|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
1060256|NCT00666965|O1|Outcome|Placebo|placebo transdermal patch
1060257|NCT00666965|O4|Outcome|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
1060227|NCT00667095|B1|Baseline|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution~Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
1060228|NCT00667095|P2|Participant Flow|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
1060229|NCT00667095|P1|Participant Flow|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution~Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
1060230|NCT00667095|O2|Outcome|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
1060231|NCT00667095|O1|Outcome|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution~Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
1060232|NCT00667095|O2|Outcome|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
1060233|NCT00667095|O1|Outcome|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution~Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
1060234|NCT00667095|O2|Outcome|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
1060235|NCT00667095|O1|Outcome|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution~Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
1060236|NCT00667095|O2|Outcome|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
1060237|NCT00667095|O1|Outcome|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution~Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
1060238|NCT00667095|O2|Outcome|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
1060239|NCT00667095|O1|Outcome|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution~Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
1060240|NCT00667095|O2|Outcome|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
1060241|NCT00667095|O1|Outcome|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution~Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
1060242|NCT00667095|E2|Reported Event|DMSO Instillation|"Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
1060243|NCT00667095|E1|Reported Event|Botox and DMSO Instillation|"Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution~Botox Instillation: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.~DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided."
1060244|NCT00666965|B5|Baseline|Total|Total of all reporting groups
1060245|NCT00666965|B4|Baseline|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
1060246|NCT00666965|B3|Baseline|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
1060247|NCT00666965|B2|Baseline|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
1060248|NCT00666965|B1|Baseline|Placebo|placebo transdermal patch
1060249|NCT00666965|P4|Participant Flow|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
1060250|NCT00666965|P3|Participant Flow|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
1060258|NCT00666965|O3|Outcome|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
1060263|NCT00666965|O2|Outcome|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
1060264|NCT00666965|O1|Outcome|Placebo|placebo transdermal patch
1060265|NCT00666965|O4|Outcome|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
1060266|NCT00666965|O3|Outcome|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
1060267|NCT00666965|O2|Outcome|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
1060268|NCT00666965|O1|Outcome|Placebo|placebo transdermal patch
1060269|NCT00666965|O4|Outcome|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
1060270|NCT00666965|O3|Outcome|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
1060271|NCT00666965|O2|Outcome|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
1060272|NCT00666965|O1|Outcome|Placebo|placebo transdermal patch
1060273|NCT00666965|O4|Outcome|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
1060274|NCT00666965|O3|Outcome|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
1060275|NCT00666965|O2|Outcome|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
1060276|NCT00666965|O1|Outcome|Placebo|placebo transdermal patch
1060277|NCT00666965|E4|Reported Event|6.75 mg/Day|SPM962 maintein dose: 6.75 mg/day
1060278|NCT00666965|E3|Reported Event|4.5 mg/Day|SPM962 maintein dose: 4.5mg/day
1060279|NCT00666965|E2|Reported Event|2.25 mg/Day|SPM962 maintein dose: 2.25 mg/day
1060280|NCT00666965|E1|Reported Event|Placebo|placebo transdermal patch
1060281|NCT00666926|B1|Baseline|Entire Study Population|PF-00562271 dose escalation administered as 5 mg PO BID up to 150 mg PO BID or 125 mg PO QD up to 225 mg PO QD. Participants in the PF-00562271125 mg BID US E1 cohort administered MDZ 2 mg/mL as a single dose on C1.D1 and C1.D21 prior to PF-00562271 dosing.
1060282|NCT00666926|P16|Participant Flow|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
1060283|NCT00666926|P15|Participant Flow|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
1060284|NCT00666926|P14|Participant Flow|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
1060285|NCT00666926|P13|Participant Flow|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
1060286|NCT00666926|P12|Participant Flow|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 (C1.D21) simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ.~Escalation and expansion cohorts were combined for reporting."
1060287|NCT00666926|P11|Participant Flow|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
1060288|NCT00666926|P10|Participant Flow|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort. Escalation and expansion cohorts were combined for reporting.
1060289|NCT00666926|P9|Participant Flow|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
1060290|NCT00666926|P8|Participant Flow|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (expansion cohort).~As of July 2008, participants newly enrolled to the expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID expansion cohort."
1060291|NCT00666926|P7|Participant Flow|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
1060292|NCT00666926|P6|Participant Flow|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
1060293|NCT00666926|P5|Participant Flow|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
1060294|NCT00666926|P4|Participant Flow|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
1060295|NCT00666926|P3|Participant Flow|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
1060296|NCT00666926|P2|Participant Flow|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
1060297|NCT00666926|P1|Participant Flow|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
1060298|NCT00666926|O16|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
1060299|NCT00666926|O15|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
1060300|NCT00666926|O14|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
1060301|NCT00666926|O13|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
1060333|NCT00666926|O13|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
1060365|NCT00666926|O13|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
1060415|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
1060416|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
1060483|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
1060302|NCT00666926|O12|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
1060303|NCT00666926|O11|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
1060304|NCT00666926|O10|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
1060305|NCT00666926|O9|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
1060306|NCT00666926|O8|Outcome|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (escalation cohort).~As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID cohort."
1060307|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
1060308|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
1060309|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
1060310|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
1060311|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
1060312|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
1060313|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
1060314|NCT00666926|O16|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
1060315|NCT00666926|O15|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
1060316|NCT00666926|O14|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
1060317|NCT00666926|O13|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
1060318|NCT00666926|O12|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
1060319|NCT00666926|O11|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
1060320|NCT00666926|O10|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
1060321|NCT00666926|O9|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
1060322|NCT00666926|O8|Outcome|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (escalation cohort).~As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID cohort."
1060323|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
1060324|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
1060325|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
1060326|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
1060327|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
1060328|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
1060329|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
1060330|NCT00666926|O16|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
1060331|NCT00666926|O15|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
1060332|NCT00666926|O14|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
1060643|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
1060334|NCT00666926|O12|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
1060335|NCT00666926|O11|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
1060336|NCT00666926|O10|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
1060337|NCT00666926|O9|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
1060338|NCT00666926|O8|Outcome|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (escalation cohort).~As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID cohort."
1060339|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
1060340|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
1060341|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
1060342|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
1060343|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
1060344|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
1060345|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
1060346|NCT00666926|O16|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
1060347|NCT00666926|O15|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
1060348|NCT00666926|O14|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
1060349|NCT00666926|O13|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
1060350|NCT00666926|O12|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
1060351|NCT00666926|O11|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
1060352|NCT00666926|O10|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
1060353|NCT00666926|O9|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
1060354|NCT00666926|O8|Outcome|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (escalation cohort).~As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID cohort."
1060355|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
1060356|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
1060357|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
1060358|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
1060359|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
1060360|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
1060361|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
1060362|NCT00666926|O16|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
1060363|NCT00666926|O15|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
1060364|NCT00666926|O14|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
1060857|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060366|NCT00666926|O12|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
1060367|NCT00666926|O11|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
1060368|NCT00666926|O10|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
1060369|NCT00666926|O9|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
1060370|NCT00666926|O8|Outcome|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (escalation cohort).~As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID cohort."
1060371|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
1060372|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
1060373|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
1060374|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
1060375|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
1060376|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
1060377|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
1060378|NCT00666926|O1|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
1060379|NCT00666926|O1|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
1060380|NCT00666926|O1|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
1060381|NCT00666926|O1|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
1060382|NCT00666926|O1|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
1060383|NCT00666926|O1|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
1060384|NCT00666926|O14|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
1060385|NCT00666926|O13|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
1060386|NCT00666926|O12|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
1060387|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
1060388|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
1060389|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
1060390|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
1060391|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
1060392|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
1060393|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
1060394|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
1060395|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
1060396|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
1060397|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
1060398|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
1060399|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
1060400|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
1060401|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
1060402|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
1060403|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
1060404|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
1060405|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
1060406|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
1060407|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
1060408|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
1060409|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
1060410|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
1060411|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
1060412|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
1060413|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
1060414|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
1060417|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
1060418|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
1060419|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
1060420|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
1060421|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
1060422|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
1060423|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
1060424|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
1060425|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
1060426|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
1060427|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
1060428|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
1060429|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
1060430|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
1060431|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
1060432|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
1060433|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
1060434|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
1060435|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
1060436|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
1060437|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
1060438|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
1060439|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
1060440|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
1060441|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
1060442|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
1060443|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
1060444|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
1060445|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
1060446|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
1060447|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
1060448|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
1060449|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
1060450|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
1060451|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
1060452|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
1060453|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
1060454|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
1060455|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
1060456|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
1060457|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
1060458|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
1060459|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
1060460|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
1060461|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
1060462|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
1060463|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
1060464|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
1060465|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
1060466|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
1060467|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
1060468|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
1060469|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
1060470|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
1060471|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
1060472|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
1060473|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
1060474|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
1060475|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
1060476|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
1060477|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
1060478|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
1060479|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
1060480|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
1060481|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
1060858|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060482|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
1060484|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
1060485|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
1060486|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
1060487|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
1060488|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
1060489|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
1060490|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
1060491|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
1060492|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
1060493|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
1060494|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
1060495|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
1060496|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
1060497|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
1060498|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
1060499|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
1060500|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
1060501|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
1060502|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
1060503|NCT00666926|O18|Outcome|PF-00562271 125 mg BID (Expansion Cohort)|"PF-00562271 administered as 125 mg PO BID w/food. As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
1060504|NCT00666926|O17|Outcome|PF-00562271 100 mg BID (Expansion Cohort)|PF-00562271 administered as 100 mg PO BID w/food. As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
1060505|NCT00666926|O16|Outcome|PF-00562271 75 mg BID (Expansion Cohort)|PF-00562271 administered as 75 mg PO BID with food w/food. As of July 2008, participants newly enrolled to the expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID expansion cohort.
1060506|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
1060507|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
1060508|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
1060509|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
1060510|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
1060511|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
1060543|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.
1060684|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
1060512|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to the expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
1060513|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
1060514|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
1060515|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
1060516|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
1060517|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
1060518|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
1060519|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
1060520|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
1060521|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
1060522|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
1060523|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
1060524|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
1060525|NCT00666926|O11|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
1060526|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
1060527|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
1060528|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
1060529|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
1060530|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
1060531|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
1060532|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
1060533|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
1060534|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
1060535|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
1060536|NCT00666926|O18|Outcome|PF-00562271 125 mg BID (Expansion Cohort)|"PF-00562271 administered as 125 mg PO BID w/food. As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
1060537|NCT00666926|O17|Outcome|PF-00562271 100 mg BID (Expansion Cohort)|PF-00562271 administered as 100 mg PO BID w/food. As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
1060538|NCT00666926|O16|Outcome|PF-00562271 75 mg BID (Expansion Cohort)|PF-00562271 administered as 75 mg PO BID with food w/food. As of July 2008, participants newly enrolled to the expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID expansion cohort.
1060539|NCT00666926|O15|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
1060540|NCT00666926|O14|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
1060541|NCT00666926|O13|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
1060542|NCT00666926|O12|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
1060544|NCT00666926|O10|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
1060545|NCT00666926|O9|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
1060546|NCT00666926|O8|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
1060547|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
1060548|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
1060549|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
1060550|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
1060551|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
1060552|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
1060553|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
1060554|NCT00666926|O1|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
1060555|NCT00666926|O16|Outcome|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
1060556|NCT00666926|O15|Outcome|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
1060557|NCT00666926|O14|Outcome|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
1060558|NCT00666926|O13|Outcome|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
1060559|NCT00666926|O12|Outcome|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ."
1060560|NCT00666926|O11|Outcome|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
1060561|NCT00666926|O10|Outcome|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort.
1060562|NCT00666926|O9|Outcome|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
1060563|NCT00666926|O8|Outcome|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (escalation cohort).~As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID cohort."
1060564|NCT00666926|O7|Outcome|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
1060565|NCT00666926|O6|Outcome|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
1060566|NCT00666926|O5|Outcome|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
1060567|NCT00666926|O4|Outcome|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
1060568|NCT00666926|O3|Outcome|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
1060569|NCT00666926|O2|Outcome|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
1060570|NCT00666926|O1|Outcome|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
1060571|NCT00666926|E16|Reported Event|PF-00562271 225 mg QD|PF-00562271 administered as 225 mg PO QD w/o food (escalation cohort).
1060572|NCT00666926|E15|Reported Event|PF-00562271 175 mg QD|PF-00562271 administered as 175 mg PO QD w/o food (escalation cohort).
1060573|NCT00666926|E14|Reported Event|PF-00562271 125 mg QD|PF-00562271 administered as 125 mg PO once a day (QD) w/o food (escalation cohort).
1060574|NCT00666926|E13|Reported Event|PF-00562271 150 mg BID|PF-00562271 administered as 150 mg PO BID w/food (escalation cohort).
1060605|NCT00666757|B1|Baseline|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
1060606|NCT00666757|P2|Participant Flow|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
1060607|NCT00666757|P1|Participant Flow|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
1060575|NCT00666926|E12|Reported Event|PF-00562271 125 mg BID|"PF-00562271 administered as 125 mg PO BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3.~Additional participants were to be enrolled to the expansion cohort at the maximum tolerated dose (MTD) 125 mg BID (expansion cohort [E1 or E2]); E1 cohort United States (US) participants received Midazolam (MDZ) syrup 2 mg per milliliter (mg/mL) as a single PO dose 24 hours prior to first PF-00562271 dose (w/o food 2 hours prior to and after MDZ dosing) and on Cycle 1, Day 21 simultaneously with PF-00562271 dosing (w/food). E1 participants outside the US and E2 participants were not dosed with MDZ.~Escalation and expansion cohorts were combined for reporting."
1060576|NCT00666926|E11|Reported Event|PF-00562271 105 mg BID|PF-00562271 administered as 105 mg PO BID w/o food (escalation cohort).
1060577|NCT00666926|E10|Reported Event|PF-00562271 100 mg BID|PF-00562271 administered as 100 mg BID w/food (escalation cohort). As of July 2008, participants newly enrolled to expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participants who were not able to titrate higher than 100 mg BID were reported in the 100 mg BID cohort. Escalation and expansion cohorts were combined for reporting.
1060578|NCT00666926|E9|Reported Event|PF-00562271 80 mg BID|PF-00562271 administered as 80 mg PO BID w/o food (escalation cohort).
1060579|NCT00666926|E8|Reported Event|PF-00562271 75 mg BID|"PF-00562271 administered as 75 mg PO BID with food (w/food: regular meal 200 to 800 calories) (expansion cohort).~As of July 2008, participants newly enrolled to the expansion cohort or who restarted treatment after dose delay associated with adverse event(s) were dosed according to intra-participant escalation (up-titration w/food): 75 mg BID week 1; 100 mg BID week 2; 125 mg BID week 3. Participant who was not able to titrate higher than 75 mg BID was reported in the 75 mg BID expansion cohort."
1060580|NCT00666926|E7|Reported Event|PF-00562271 60 mg BID|PF-00562271 administered as 60 mg PO BID w/o food (escalation cohort).
1060581|NCT00666926|E6|Reported Event|PF-00562271 45 mg BID|PF-00562271 administered as 45 mg PO BID w/o food (escalation cohort).
1060582|NCT00666926|E5|Reported Event|PF-00562271 35 mg BID|PF-00562271 administered as 35 mg PO BID w/o food (escalation cohort).
1060583|NCT00666926|E4|Reported Event|PF-00562271 25 mg BID|PF-00562271 administered as 25 mg PO BID w/o food (escalation cohort).
1060584|NCT00666926|E3|Reported Event|PF-00562271 15 mg BID|PF-00562271 administered as 15 mg PO BID w/o food (escalation cohort).
1060585|NCT00666926|E2|Reported Event|PF-00562271 10 mg BID|PF-00562271 administered as 10 mg PO BID w/o food (escalation cohort).
1060586|NCT00666926|E1|Reported Event|PF-00562271 5 mg BID|PF-00562271 administered as 5 milligrams (mg) orally (PO) twice a day (BID) without food (w/o food: no food within 2 hours prior to dosing) (escalation cohort).
1060587|NCT00666848|B4|Baseline|Total|Total of all reporting groups
1060588|NCT00666848|B3|Baseline|3 (Enalapril 10mg)|Subjects received Enalapril 10mg on study day and a placebo pill for 5 days prior, or subjects received Enalapril 10mg on study day and sitagliptin 100mg for 5 days prior.
1060589|NCT00666848|B2|Baseline|1 (Placebo)|Subjects received a placebo pill on study day and received a placebo pill for 5 days prior or subjects received a Placebo pill on study day and sitagliptin 100mg for 5 days prior.
1060590|NCT00666848|B1|Baseline|2 (Enalapril 5mg)|Subjects received Enalapril 5mg on study day and a placebo pill for 5 days prior or subjects received enalapril 5mg on study day and sitagliptin 100mg/day for 5 days prior .
1060591|NCT00666848|P3|Participant Flow|3 (Enalapril 10mg)|Subjects received Enalapril 10mg on study day and a placebo pill for 5 days prior, or subjects received Enalapril 10mg on study day and sitagliptin 100mg for 5 days prior.
1060592|NCT00666848|P2|Participant Flow|1 (Placebo)|Subjects received a placebo pill on study day and received a placebo pill for 5 days prior or subjects received a Placebo pill on study day and sitagliptin 100mg for 5 days prior.
1060593|NCT00666848|P1|Participant Flow|2 (Enalapril 5mg)|Subjects received Enalapril 5mg on study day and a placebo pill for 5 days prior or subjects received enalapril 5mg on study day and sitagliptin 100mg/day for 5 days prior .
1060594|NCT00666848|O3|Outcome|3 (Enalapril 10mg)|Subjects received Enalapril 10mg on study day and a placebo pill for 5 days prior, or subjects received Enalapril 10mg on study day and sitagliptin 100mg for 5 days prior.
1060595|NCT00666848|O2|Outcome|1 (Placebo)|Subjects received a placebo pill on study day and received a placebo pill for 5 days prior or subjects received a Placebo pill on study day and sitagliptin 100mg for 5 days prior.
1060596|NCT00666848|O1|Outcome|2 (Enalapril 5mg)|Subjects received Enalapril 5mg on study day and a placebo pill for 5 days prior or subjects received enalapril 5mg on study day and sitagliptin 100mg/day for 5 days prior .
1060597|NCT00666848|O3|Outcome|3 (Enalapril 10mg)|Subjects received Enalapril 10mg on study day and a placebo pill for 5 days prior, or subjects received Enalapril 10mg on study day and sitagliptin 100mg for 5 days prior.
1060598|NCT00666848|O2|Outcome|1 (Placebo)|Subjects received a placebo pill on study day and received a placebo pill for 5 days prior or subjects received a Placebo pill on study day and sitagliptin 100mg for 5 days prior.
1060599|NCT00666848|O1|Outcome|2 (Enalapril 5mg)|Subjects received Enalapril 5mg on study day and a placebo pill for 5 days prior or subjects received enalapril 5mg on study day and sitagliptin 100mg/day for 5 days prior .
1060600|NCT00666848|E3|Reported Event|3 (Enalapril 10mg)|Subjects received Enalapril 10mg on study day and a placebo pill for 5 days prior, or subjects received Enalapril 10mg on study day and sitagliptin 100mg for 5 days prior.
1060601|NCT00666848|E2|Reported Event|1 (Placebo)|Subjects received a placebo pill on study day and received a placebo pill for 5 days prior or subjects received a Placebo pill on study day and sitagliptin 100mg for 5 days prior.
1060602|NCT00666848|E1|Reported Event|2 (Enalapril 5mg)|Subjects received Enalapril 5mg on study day and a placebo pill for 5 days prior or subjects received enalapril 5mg on study day and sitagliptin 100mg/day for 5 days prior .
1060603|NCT00666757|B3|Baseline|Total|Total of all reporting groups
1060604|NCT00666757|B2|Baseline|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
1060608|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
1060609|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
1060610|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
1060611|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
1060612|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
1060613|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
1060614|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
1060615|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
1060616|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
1060617|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
1060618|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
1060619|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
1060620|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
1060621|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
1060622|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
1060623|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
1060624|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
1060625|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
1060626|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
1060627|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
1060628|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
1060629|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
1060630|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
1060631|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
1060632|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
1060633|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
1060634|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
1060635|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
1060636|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
1060637|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
1060638|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
1060639|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
1060640|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
1060641|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
1060642|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
1060644|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
1060645|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
1060646|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
1060647|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
1060648|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
1060649|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
1060650|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
1060651|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
1060652|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
1060653|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
1060654|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
1060655|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
1060656|NCT00666757|O2|Outcome|Selective Serotonin Reuptake Inhibitor (SSRI)|all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
1060657|NCT00666757|O1|Outcome|Duloxetine|30-120 milligrams (mgs) orally daily for 12 weeks
1060658|NCT00666757|E5|Reported Event|Sertraline|50-200 mg orally daily for 12 weeks
1060659|NCT00666757|E4|Reported Event|Paroxetine|20-50 mg orally daily for 12 weeks
1060660|NCT00666757|E3|Reported Event|Fluoxetine|20-80 mg orally daily for 12 weeks
1060661|NCT00666757|E2|Reported Event|Citalopram|20-40 mg orally daily for 12 weeks
1060662|NCT00666757|E1|Reported Event|Duloxetine|30-120 mg orally daily for 12 weeks
1060663|NCT00666718|B3|Baseline|Total|Total of all reporting groups
1060664|NCT00666718|B2|Baseline|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin
1060665|NCT00666718|B1|Baseline|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin
1060666|NCT00666718|P2|Participant Flow|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin
1060667|NCT00666718|P1|Participant Flow|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin
1060668|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
1060669|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
1060670|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
1060671|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
1060672|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
1060673|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
1060674|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
1060675|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
1060676|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
1060677|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
1060678|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
1060679|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
1060680|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
1060681|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
1060682|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
1060683|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
1060685|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
1060686|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
1060687|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
1060688|NCT00666718|O2|Outcome|ILPS|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks
1060689|NCT00666718|O1|Outcome|Glargine|Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
1060690|NCT00666718|E2|Reported Event|Lispro/Metformin|Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin
1060691|NCT00666718|E1|Reported Event|Glargine/Lispro|Glargine plus Insulin Lispro (2-3 injections) plus metformin
1060692|NCT00666705|B1|Baseline|Maraviroc / Raltegravir (Alone and Co-administered)|"All subjects received the following fixed sequence study treatments:~Days 1-3: raltegravir 400 mg every 12 hours (AM dose on Day 3) Days 4-5: washout Days 6-11: maraviroc 300 mg every 12 hours Days 12-14: raltegravir 400 mg every 12 hours and maraviroc 300 mg every 12 hours (AM doses on Day 14)."
1060693|NCT00666705|P1|Participant Flow|Maraviroc / Raltegravir (Alone and Co-administered)|"All subjects received the following fixed sequence study treatments:~Days 1-3: raltegravir 400 milligrams (mg) every 12 hours (AM dose on Day 3) Days 4-5: washout Days 6-11: maraviroc 300 mg every 12 hours Days 12-14: raltegravir 400 mg every 12 hours and maraviroc 300 mg every 12 hours (AM doses on Day 14)."
1060694|NCT00666705|O2|Outcome|Raltegravir (Reference)|400 mg every 12 hours on Study Days 1-3 Followed by washout on Study Days 4-5
1060695|NCT00666705|O1|Outcome|Maraviroc + Raltegravir (Test)|On Study Days 12-14: Raltegravir 400mg every 12 hours, maraviroc 300mg every 12 hours (AM doses only on Day 14)
1060696|NCT00666705|O2|Outcome|Raltegravir (Reference)|400 mg every 12 hours on Study Days 1-3 Followed by washout on Study Days 4-5
1060697|NCT00666705|O1|Outcome|Maraviroc + Raltegravir (Test)|On Study Days 12-14: Raltegravir 400mg every 12 hours, maraviroc 300mg every 12 hours (AM doses only on Day 14)
1060698|NCT00666705|O2|Outcome|Maraviroc (Reference)|300 mg every 12 hours on Study Days 6-11
1060699|NCT00666705|O1|Outcome|Maraviroc + Raltegravir (Test)|On Study Days 12-14: Raltegravir 400 mg every 12 hours, maraviroc 300 mg every 12 hours (AM doses only on Day 14)
1060700|NCT00666705|O2|Outcome|Raltegravir (Reference)|400 mg every 12 hours on Study Days 1-3 Followed by washout on Study Days 4-5
1060701|NCT00666705|O1|Outcome|Maraviroc + Raltegravir (Test)|On Study Days 12-14: Raltegravir 400mg every 12 hours, maraviroc 300mg every 12 hours (AM doses only on Day 14)
1060702|NCT00666705|O2|Outcome|Maraviroc (Reference)|300 mg every 12 hours on Study Days 6-11
1060703|NCT00666705|O1|Outcome|Maraviroc + Raltegravir (Test)|On Study Days 12-14: Raltegravir 400 mg every 12 hours, maraviroc 300 mg every 12 hours (AM doses only on Day 14)
1060704|NCT00666705|O2|Outcome|Maraviroc (Reference)|300 mg every 12 hours on Study Days 6-11
1060705|NCT00666705|O1|Outcome|Maraviroc + Raltegravir (Test)|On Study Days 12-14: Raltegravir 400 mg every 12 hours, maraviroc 300 mg every 12 hours (AM doses only on Day 14)
1060706|NCT00666705|E3|Reported Event|Raltegravir|400 milligrams (mg) every 12 hours on Study Days 1-3 Followed by washout on Study Days 4-5
1060707|NCT00666705|E2|Reported Event|Maraviroc + Raltegravir|On Study Days 12-14: Raltegravir 400 milligrams (mg) every 12 hours, maraviroc 300 mg every 12 hours (AM doses only on Day 14)
1060708|NCT00666705|E1|Reported Event|Maraviroc|300 milligrams (mg) every 12 hours on Study Days 6-11
1060709|NCT00666679|B3|Baseline|Total|Total of all reporting groups
1060710|NCT00666679|B2|Baseline|Placebo + Mometasone Then Montelukast + Mometasone|Patients were randomized to receive placebo for montelukast and open-label mometasone 220 mcg once daily by inhalation in the first intervention; and montelukast 1 mg and open-label mometasone 220 mcg once daily by inhalation in the second intervention (after washout). During washout, patients received open-label inhaled mometasone 220 mcg and single-blind placebo for montelukast once daily by inhalation.
1060711|NCT00666679|B1|Baseline|Montelukast + Mometasone Then Placebo + Mometasone|Patients were randomized to receive montelukast 1 mg (milligram) and open-label mometasone 220 mcg (micrograms) once daily by inhalation in the first intervention; and placebo for montelukast and open-label mometasone 220 mcg once daily by inhalation in the second intervention (after washout). During washout, patients received open-label inhaled mometasone 220 mcg and single-blind placebo for montelukast once daily by inhalation.
1060712|NCT00666679|P2|Participant Flow|Placebo + Mometasone Then Montelukast + Mometasone|Patients were randomized to receive placebo for montelukast and open-label mometasone 220 mcg once daily by inhalation in the first intervention; and montelukast 1 mg and open-label mometasone 220 mcg once daily by inhalation in the second intervention (after washout). During washout, patients received open-label inhaled mometasone 220 mcg and single-blind placebo for montelukast once daily by inhalation.
1060713|NCT00666679|P1|Participant Flow|Montelukast + Mometasone Then Placebo + Mometasone|Patients were randomized to receive montelukast 1 mg (milligram) and open-label mometasone 220 mcg (micrograms) once daily by inhalation in the first intervention; and placebo for montelukast and open-label mometasone 220 mcg once daily by inhalation in the second intervention (after washout). During washout, patients received open-label inhaled mometasone 220 mcg and single-blind placebo for montelukast once daily by inhalation.
1060714|NCT00666679|O2|Outcome|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
1060715|NCT00666679|O1|Outcome|Montelukast + Mometasone|Inhaled montelukast 1mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
1060716|NCT00666679|O2|Outcome|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
1060717|NCT00666679|O1|Outcome|Montelukast + Mometasone|Inhaled montelukast 1mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
1069719|NCT00639223|O2|Outcome|Red Yeast Rice|
1060718|NCT00666679|O2|Outcome|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
1060719|NCT00666679|O1|Outcome|Montelukast + Mometasone|Inhaled montelukast 1mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
1060720|NCT00666679|O2|Outcome|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
1060721|NCT00666679|O1|Outcome|Montelukast + Mometasone|Inhaled montelukast 1mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
1060722|NCT00666679|O2|Outcome|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
1060723|NCT00666679|O1|Outcome|Montelukast + Mometasone|Inhaled montelukast 1mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
1060724|NCT00666679|O2|Outcome|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
1060725|NCT00666679|O1|Outcome|Montelukast + Mometasone|Inhaled montelukast 1mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
1060726|NCT00666679|O2|Outcome|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
1060727|NCT00666679|O1|Outcome|Montelukast + Mometasone|Inhaled montelukast 1mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
1060728|NCT00666679|O2|Outcome|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
1060729|NCT00666679|O1|Outcome|Montelukast + Mometasone|Inhaled montelukast 1mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
1060730|NCT00666679|E2|Reported Event|Placebo + Mometasone|Inhaled placebo for montelukast and open label mometasone 220 mcg once daily.
1060731|NCT00666679|E1|Reported Event|Montelukast + Mometasone|Inhaled montelukast 1 mg (milligram) and open label mometasone 220 mcg (micrograms) once daily.
1060732|NCT00666666|B1|Baseline|AT101 (R-(-)-Gossypol Acetic Acid)|
1060733|NCT00666666|P1|Participant Flow|AT101 (R-(-)-Gossypol Acetic Acid)|"Patients will receive Hormone therapy with at least one LHRH agent (Leuprolide Acetate or Goserelin) for 6 weeks and include bicalutamide. Patients will begin AT101 daily at 6 weeks for 3 weeks of every 4 weeks (4 weeks - 1 cycle) and continue for 8 cycles of combined therapy (combined AT101, and LHRH agonist). After 8 cycles patients will continue hormonal therapy.~AT-101 : AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle.~Bicalutamide : Daily bicalutamide 50 mg po is encouraged for the first month of LHRH agonist therapy to prevent a flare. Continued bicalutamide use is optional. Bicalutamide will be administered orally at a dose of 50 mg po daily, Day 1 to 28 of each cycle.~LHRH agent : An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used."
1060734|NCT00666666|O1|Outcome|AT101 (R-(-)-Gossypol Acetic Acid)|"Patients will receive Hormone therapy with at least one LHRH agent (Leuprolide Acetate or Goserelin) for 6 weeks and include bicalutamide. Patients will begin AT101 daily at 6 weeks for 3 weeks of every 4 weeks (4 weeks - 1 cycle) and continue for 8 cycles of combined therapy (combined AT101, and LHRH agonist). After 8 cycles patients will continue hormonal therapy.~AT-101 : AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle.~Bicalutamide : Daily bicalutamide 50 mg po is encouraged for the first month of LHRH agonist therapy to prevent a flare. Continued bicalutamide use is optional. Bicalutamide will be administered orally at a dose of 50 mg po daily, Day 1 to 28 of each cycle.~LHRH agent : An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used."
1060735|NCT00666666|O1|Outcome|AT101 (R-(-)-Gossypol Acetic Acid)|"Patients will receive Hormone therapy with at least one LHRH agent (Leuprolide Acetate or Goserelin) for 6 weeks and include bicalutamide. Patients will begin AT101 daily at 6 weeks for 3 weeks of every 4 weeks (4 weeks - 1 cycle) and continue for 8 cycles of combined therapy (combined AT101, and LHRH agonist). After 8 cycles patients will continue hormonal therapy.~AT-101 : AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle.~Bicalutamide : Daily bicalutamide 50 mg po is encouraged for the first month of LHRH agonist therapy to prevent a flare. Continued bicalutamide use is optional. Bicalutamide will be administered orally at a dose of 50 mg po daily, Day 1 to 28 of each cycle.~LHRH agent : An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used."
1060736|NCT00666666|O1|Outcome|AT101 (R-(-)-Gossypol Acetic Acid)|"Patients will receive Hormone therapy with at least one LHRH agent (Leuprolide Acetate or Goserelin) for 6 weeks and include bicalutamide. Patients will begin AT101 daily at 6 weeks for 3 weeks of every 4 weeks (4 weeks - 1 cycle) and continue for 8 cycles of combined therapy (combined AT101, and LHRH agonist). After 8 cycles patients will continue hormonal therapy.~AT-101 : AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle.~Bicalutamide : Daily bicalutamide 50 mg po is encouraged for the first month of LHRH agonist therapy to prevent a flare. Continued bicalutamide use is optional. Bicalutamide will be administered orally at a dose of 50 mg po daily, Day 1 to 28 of each cycle.~LHRH agent : An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used."
1060737|NCT00666666|E1|Reported Event|AT101 (R-(-)-Gossypol Acetic Acid)|"Patients will receive Hormone therapy with at least one LHRH agent (Leuprolide Acetate or Goserelin) for 6 weeks and include bicalutamide. Patients will begin AT101 daily at 6 weeks for 3 weeks of every 4 weeks (4 weeks - 1 cycle) and continue for 8 cycles of combined therapy (combined AT101, and LHRH agonist). After 8 cycles patients will continue hormonal therapy.~AT-101 : AT101 will be administered orally 20 mg/day for 21 days of a 28 day cycle.~Bicalutamide : Daily bicalutamide 50 mg po is encouraged for the first month of LHRH agonist therapy to prevent a flare. Continued bicalutamide use is optional. Bicalutamide will be administered orally at a dose of 50 mg po daily, Day 1 to 28 of each cycle.~LHRH agent : An LHRH agonist(Leuprolide Acetate or Goserelin)can be administered at standard dosing appropriate to the agent used."
1060738|NCT00666588|B5|Baseline|Total|Total of all reporting groups
1060739|NCT00666588|B4|Baseline|Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess efficacy in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
1069720|NCT00639223|O1|Outcome|Pravastatin|
1060863|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060740|NCT00666588|B3|Baseline|Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (dose-finding phase closed as of 10/10).~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
1060741|NCT00666588|B2|Baseline|Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.0 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.0 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
1060742|NCT00666588|B1|Baseline|Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure|"Bortezomib 1.3mg/m2 to assess efficacy in low prior anthracycline exposure. Patients receive idarubicin IV (12 mg/m2/day) over 15 minutes on days 1-3, low-dose cytarabine IV (100 mg/m2/day) continuously over days 1-7, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (closed as of 08/01/10). Dosage modification based on age < 3 years old.~idarubicin: Given IV~cytarabine: Given IV or IT~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies"
1060743|NCT00666588|P4|Participant Flow|Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess efficacy in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
1060744|NCT00666588|P3|Participant Flow|Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (dose-finding phase closed as of 10/10).~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
1060745|NCT00666588|P2|Participant Flow|Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.0 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.0 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
1060746|NCT00666588|P1|Participant Flow|Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure|"Bortezomib 1.3mg/m2 to assess efficacy in low prior anthracycline exposure. Patients receive idarubicin IV (12 mg/m2/day) over 15 minutes on days 1-3, low-dose cytarabine IV (100 mg/m2/day) continuously over days 1-7, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (closed as of 08/01/10). Dosage modification based on age < 3 years old.~idarubicin: Given IV~cytarabine: Given IV or IT~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies"
1060747|NCT00666588|O4|Outcome|Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess efficacy in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
1060748|NCT00666588|O3|Outcome|Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (dose-finding phase closed as of 10/10).~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
1060778|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060859|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060860|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1069721|NCT00639223|E2|Reported Event|Red Yeast Rice|
1060749|NCT00666588|O2|Outcome|Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.0 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.0 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
1060750|NCT00666588|O1|Outcome|Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure|"Bortezomib 1.3mg/m2 to assess efficacy in low prior anthracycline exposure. Patients receive idarubicin IV (12 mg/m2/day) over 15 minutes on days 1-3, low-dose cytarabine IV (100 mg/m2/day) continuously over days 1-7, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (closed as of 08/01/10). Dosage modification based on age < 3 years old.~idarubicin: Given IV~cytarabine: Given IV or IT~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies"
1060751|NCT00666588|O4|Outcome|Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess efficacy in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
1060752|NCT00666588|O3|Outcome|Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (dose-finding phase closed as of 10/10).~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
1060753|NCT00666588|O2|Outcome|Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.0 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.0 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
1060754|NCT00666588|O1|Outcome|Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure|"Bortezomib 1.3mg/m2 to assess efficacy in low prior anthracycline exposure. Patients receive idarubicin IV (12 mg/m2/day) over 15 minutes on days 1-3, low-dose cytarabine IV (100 mg/m2/day) continuously over days 1-7, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (closed as of 08/01/10). Dosage modification based on age < 3 years old.~idarubicin: Given IV~cytarabine: Given IV or IT~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies"
1060755|NCT00666588|E4|Reported Event|Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess efficacy in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
1060756|NCT00666588|E3|Reported Event|Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.3 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (dose-finding phase closed as of 10/10).~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
1060757|NCT00666588|E2|Reported Event|Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp|"Bortezomib 1.0 mg/m2 to assess feasibility in high prior anthracycline exposure. Patients receive etoposide IV (150 mg/m2/dose) over 1 hour on days 1-5, high-dose cytarabine IV (1000 mg/m2/dose) over 1 hour twice daily on days 1-5, and bortezomib IV (1.0 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.~cytarabine: Given IV or IT~bortezomib: Given IV~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
1060779|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060861|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060862|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060758|NCT00666588|E1|Reported Event|Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure|"Bortezomib 1.3mg/m2 to assess efficacy in low prior anthracycline exposure. Patients receive idarubicin IV (12 mg/m2/day) over 15 minutes on days 1-3, low-dose cytarabine IV (100 mg/m2/day) continuously over days 1-7, and bortezomib IV (1.3 mg/m2) on days 1, 4, and 8. All patients receive intrathecal cytarabine (30 mg - age 1-1.99 years, 50 mg - age 2-2.99 years, 70 mg - age ≥ 3 years) prior to courses 1 and 2. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity (closed as of 08/01/10). Dosage modification based on age < 3 years old.~idarubicin: Given IV~cytarabine: Given IV or IT~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies"
1060759|NCT00666562|B4|Baseline|Total|Total of all reporting groups
1060760|NCT00666562|B3|Baseline|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060761|NCT00666562|B2|Baseline|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060762|NCT00666562|B1|Baseline|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060763|NCT00666562|P3|Participant Flow|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060764|NCT00666562|P2|Participant Flow|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060765|NCT00666562|P1|Participant Flow|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060766|NCT00666562|O4|Outcome|7/7 Genotype|Genotype of the UGT in EGCG
1060767|NCT00666562|O3|Outcome|6/7 Genotype|Genotype of the UGT in EGCG
1060768|NCT00666562|O2|Outcome|6/6 Genotype|Genotype of the UGT in EGCG
1060769|NCT00666562|O1|Outcome|5/6 Genotype|Genotype of the UGT in EGCG
1060770|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060771|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060772|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060773|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060774|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060775|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060776|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060777|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060780|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060781|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060782|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060783|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060784|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060785|NCT00666562|O3|Outcome|Alanine/Alanine|A to A transition in the COMT gene
1060786|NCT00666562|O2|Outcome|Alanine/Glycine|A to G transition in the COMT gene
1060787|NCT00666562|O1|Outcome|Glycine/Glycine|G to G transition in the COMT gene
1060788|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060789|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060790|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060791|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060792|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060793|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060794|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060795|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060796|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060797|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060798|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060856|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060799|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060800|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060801|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060802|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060803|NCT00666562|O3|Outcome|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060804|NCT00666562|O2|Outcome|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060805|NCT00666562|O1|Outcome|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060806|NCT00666562|E3|Reported Event|Arm III (1200mg Polyphenon E)|"Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060807|NCT00666562|E2|Reported Event|Arm II (800mg Polyphenon E, Placebo)|"Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~defined green tea catechin extract: Given orally~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060808|NCT00666562|E1|Reported Event|Arm I (Placebo)|"Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.~placebo: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1060809|NCT00666536|B3|Baseline|Total|Total of all reporting groups
1060810|NCT00666536|B2|Baseline|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
1060811|NCT00666536|B1|Baseline|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
1060812|NCT00666536|P2|Participant Flow|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
1060813|NCT00666536|P1|Participant Flow|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
1060814|NCT00666536|O2|Outcome|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
1060815|NCT00666536|O1|Outcome|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
1060816|NCT00666536|O2|Outcome|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
1060817|NCT00666536|O1|Outcome|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
1069722|NCT00639223|E1|Reported Event|Pravastatin|
1060818|NCT00666536|O2|Outcome|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
1060819|NCT00666536|O1|Outcome|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
1060820|NCT00666536|O2|Outcome|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
1060821|NCT00666536|O1|Outcome|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
1060822|NCT00666536|O2|Outcome|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
1060823|NCT00666536|O1|Outcome|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
1060824|NCT00666536|O2|Outcome|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
1060825|NCT00666536|O1|Outcome|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
1060826|NCT00666536|E2|Reported Event|Moderate Treatment Regimen (5/160 mg)|Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
1060827|NCT00666536|E1|Reported Event|Aggressive Treatment Regimen (5/320 mg to 10/320 mg)|Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
1060828|NCT00666458|B3|Baseline|Total|Total of all reporting groups
1060829|NCT00666458|B2|Baseline|Sita + Met|Sitagliptin 100 mg capsules added on to open-label metformin
1060830|NCT00666458|B1|Baseline|Saxa + Met|Saxagliptin 5 mg tablets added on to open-label metformin
1060831|NCT00666458|P2|Participant Flow|Sita + Met|Sitagliptin 100 mg capsules added on to open-label metformin
1060832|NCT00666458|P1|Participant Flow|Saxa + Met|Saxagliptin 5 mg tablets added on to open-label metformin
1060833|NCT00666458|O2|Outcome|Sita + Met|Sitagliptin 100 mg capsules added on to open-label metformin
1060834|NCT00666458|O1|Outcome|Saxa + Met|Saxagliptin 5 mg tablets added on to open-label metformin
1060835|NCT00666458|O2|Outcome|Sita + Met|Sitagliptin 100 mg capsules added on to open-label metformin
1060836|NCT00666458|O1|Outcome|Saxa + Met|Saxagliptin 5 mg tablets added on to open-label metformin
1060837|NCT00666458|O2|Outcome|Sita + Met|Sitagliptin 100 mg capsules added on to open-label metformin
1060838|NCT00666458|O1|Outcome|Saxa + Met|Saxagliptin 5 mg tablets added on to open-label metformin
1060839|NCT00666458|O2|Outcome|Sita + Met|Sitagliptin 100 mg capsules added on to open-label metformin
1060840|NCT00666458|O1|Outcome|Saxa + Met|Saxagliptin 5 mg tablets added on to open-label metformin
1060841|NCT00666458|E2|Reported Event|Sita + Met|Sitagliptin 100 mg capsules added on to open-label metformin
1060842|NCT00666458|E1|Reported Event|Saxa + Met|Saxagliptin 5 mg tablets added on to open-label metformin
1060843|NCT00666406|B1|Baseline|All Study Participants|Includes groups randomized to receive Advate rAHF-PFM and Recombinate rAHF first.
1060844|NCT00666406|P2|Participant Flow|Recombinate rAHF Then Advate rAHF-PFM|"First infusion - Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight~Second infusion - Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight"
1060845|NCT00666406|P1|Participant Flow|Advate rAHF-PFM Then Recombinate rAHF|"First infusion - Advate Antihemophilic Factor (Recombinant)–Plasma/Albumin Free Method (rAHF-PFM): Infusion of 50 +/- 5 IU/kg bodyweight~Second infusion - Recombinate Antihemophilic Factor (Recombinant) (rAHF): Infusion of 50 +/- 5 IU/kg bodyweight"
1060846|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060847|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060848|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060849|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060850|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060851|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060852|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060853|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060854|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060855|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060864|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060865|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060866|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060867|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060868|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060869|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060870|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060871|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060872|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060873|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060874|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060875|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060876|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060877|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060878|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060879|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060880|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060881|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060882|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060883|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060884|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060885|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060886|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060887|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060888|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060889|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060890|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060891|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060892|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060893|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060894|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060895|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060896|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060897|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060898|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060899|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060900|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060901|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060902|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060903|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060904|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060905|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060906|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060907|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060908|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060909|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060910|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060911|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060912|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060913|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060914|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060915|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060916|NCT00666406|O2|Outcome|Recombinate rAHF|Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
1060917|NCT00666406|O1|Outcome|Advate rAHF-PFM|Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
1060918|NCT00666406|E1|Reported Event|All Study Participants|Includes groups randomized to receive Advate rAHF-PFM and Recombinate rAHF first.
1060919|NCT00666328|B1|Baseline|Clevidipine|"mITT (Modified Intent To Treat) Population (n=33): This population is the primary population for the efficacy analyses.~Clevidipine was administered to eligible participants via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes. Clevidipine was titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg) for a minimum of 30 minutes and up to 96 hours. Clevidipine was titrated up or down as necessary to maintain blood pressure within the target range."
1061276|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1060920|NCT00666328|P1|Participant Flow|Clevidipine|Clevidipine was administered to eligible participants via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes. Clevidipine was titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg) for a minimum of 30 minutes and up to 96 hours.
1060921|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
1060922|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
1060923|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
1060924|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours
1060925|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
1060926|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
1060927|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg) for 30 minutes to 96 hours. Clevidipine was titrated up or down as necessary to maintain blood pressure within the target range.
1060928|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
1060929|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
1060930|NCT00666328|O1|Outcome|Clevidipine|Clevidipine was administered via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes and titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg). Clevidipine was titrated up or down, as necessary, to maintain blood pressure within the target range for a minimum of 30 minutes to a maximum of 96 hours.
1060931|NCT00666328|E1|Reported Event|Clevidipine|"Safety Population (n=35): This population is the primary population for the safety analyses.~Clevidipine was administered to eligible participants via intravenous infusion at a starting dose of 2.0 mg/h for 1.5 minutes. Clevidipine was titrated to effect thereafter by doubling the dose every 1.5 minutes, as tolerated by the patient, up to a maximum dose of 32 mg/h, to lower blood pressure within the protocol specific target range (SBP ≤160 mmHg to ≥140 mmHg) for a minimum of 30 minutes and up to 96 hours. Clevidipine was titrated up or down as necessary to maintain blood pressure within the target range."
1060932|NCT00666276|B1|Baseline|Linezolid|Participants who have been treated with Linezolid.
1060933|NCT00666276|P1|Participant Flow|Linezolid|Participants who have been treated with Linezolid.
1060934|NCT00666276|O2|Outcome|Linezolid-with Non-drug Therapies|Participants with Non-drug therapies who have been treated with Linezolid.
1060935|NCT00666276|O1|Outcome|Linezolid-without Non-drug Therapies|Participants without Non-drug therapies who have been treated with Linezolid.
1060936|NCT00666276|O2|Outcome|Linezolid-with Concomitant Drugs|Participants with Concomitant drugs who have been treated with Linezolid.
1060937|NCT00666276|O1|Outcome|Linezolid-without Concomitant Drugs|Participants without Concomitant drugs who have been treated with Linezolid.
1060938|NCT00666276|O2|Outcome|Linezolid -Less Than 40kg|Participants less than 40kg who have been treated with Linezolid.
1060939|NCT00666276|O1|Outcome|Linezolid -Over 40kg|Participants over 40kg who have been treated with Linezolid.
1069723|NCT00639158|B3|Baseline|Total|Total of all reporting groups
1060940|NCT00666276|O3|Outcome|Linezolid-oral From Injection|Participants with who have been treated with Linezolid by orally from injection .
1060941|NCT00666276|O2|Outcome|Linezolid-injection|Participants with who have been treated with Linezolid by injection.
1060942|NCT00666276|O1|Outcome|Linezolid-oral|Participants with who have been orally treated with Linezolid.
1060943|NCT00666276|O2|Outcome|Linezolid-administrated Less Than 15 Days|Participants with who have been treated with Linezolid.with Duration of drug administration less than 15 days
1060944|NCT00666276|O1|Outcome|Linezolid-administrated Over 15 Days|Participants who have been treated with Linezolid.with Duration of drug administration over 15 days
1060945|NCT00666276|O2|Outcome|Linezolid- With Renal Dysfunctions|Participants with Renal dysfunctions who have been treated with Linezolid.
1060946|NCT00666276|O1|Outcome|Linezolid Without Renal Dysfunctions|Participants without Renal dysfunctions who have been treated with Linezolid.
1060947|NCT00666276|O2|Outcome|Linezolid- With Hepatic Dysfunctions|Participants with Hepatic dysfunctions who have been treated with Linezolid.
1060948|NCT00666276|O1|Outcome|Linezolid-without Hepatic Dysfunctions|Participants with or without Hepatic dysfunctions who have been treated with Linezolid.
1060949|NCT00666276|O2|Outcome|Linezolid-less Than 65|Participants with less than 65 years old who have been treated with Linezolid.
1060950|NCT00666276|O1|Outcome|Linezolid-over 65|Participants with over 65 years old who have been treated with Linezolid.
1060951|NCT00666276|O2|Outcome|Linezolid-female|Female participants who have been treated with Linezolid.
1060952|NCT00666276|O1|Outcome|Linezolid-male|Male participants who have been treated with Linezolid.
1060953|NCT00666276|O1|Outcome|Linezolid|Participants who have been treated with Linezolid.
1060954|NCT00666276|O1|Outcome|Linezolid|Participants who have been treated with Linezolid.
1060955|NCT00666276|E1|Reported Event|Linezolid|Participants who have been treated with Linezolid.
1060956|NCT00666263|B1|Baseline|All Study Participants|"Each participant was to complete 5 study parts (3 stabilization phases of open label treatment with IGIV, 10%, and 1 cross-over period each of double-blind treatment with IGIV, 10% and placebo according to a randomized sequence). Each study part lasted 12 weeks and comprised 3, 4 or 6 infusion cycles depending on treatment interval.~Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) for all participants Study Part 2: Participants were randomized to 1 of 2 sequences of double-blind treatment (either: IGIV, 10% or placebo) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Participants were crossed-over to second sequence of double-blind treatment (IGIV, 10% or placebo) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)"
1060957|NCT00666263|P2|Participant Flow|Placebo Then IGIV, 10% (During Cross-Over Periods)|Each of the following 5 study parts is 12 weeks. Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 3)
1060958|NCT00666263|P1|Participant Flow|IGIV, 10% Then Placebo (During Cross-Over Periods)|Each of the following 5 study parts is 12 weeks. Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 3)
1060959|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1060960|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1060961|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1061084|NCT00666263|O2|Outcome|Decline Only During Placebo|Participants who experienced a relative decrease in grip strength of ≥30% in the more affected hand relative to baseline following the placebo, but not after IGIV, 10%
1060962|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1060963|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1060964|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1060965|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1060966|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1060967|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1060968|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1060969|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1060970|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1061025|NCT00666263|O7|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
1061026|NCT00666263|O6|Outcome|End of Stabilization 3|IGIV, 10%
1071164|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
1060971|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1060972|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1060973|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1060974|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1060975|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1060976|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1060977|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1060978|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1060979|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1061027|NCT00666263|O5|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
1061028|NCT00666263|O4|Outcome|End of Stabilization 2|IGIV, 10%
1061029|NCT00666263|O3|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
1061030|NCT00666263|O2|Outcome|End of Stabilization 1|IGIV, 10% (IGIV)
1061031|NCT00666263|O1|Outcome|Before Stabilization 1|Baseline Measurements
1060980|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1060981|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1060982|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1060983|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1060984|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1060985|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1060986|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1060987|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1060988|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1061047|NCT00666263|O7|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
1061048|NCT00666263|O6|Outcome|End of Stabilization 3|IGIV, 10%
1071221|NCT00635817|B5|Baseline|Total|Total of all reporting groups
1060989|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1060990|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1060991|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1060992|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1060993|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1060994|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1060995|NCT00666263|O4|Outcome|No Deterioration After IGIV, 10% or Placebo|Participants with no deterioration in GNDS scores after IGIV, 10% or Placebo
1060996|NCT00666263|O3|Outcome|Deterioration After IGIV, 10%, But Not Placebo|Participants with deterioration in GNDS scores after IGIV, 10%, but not Placebo
1060997|NCT00666263|O2|Outcome|Deterioration After Placebo, But Not IGIV, 10%|Participants with deterioration in GNDS scores after Placebo, but not IGIV, 10%
1060998|NCT00666263|O1|Outcome|Deterioration After IGIV, 10% and Placebo|Participants with deterioration in GNDS scores after IGIV, 10% and placebo
1060999|NCT00666263|O4|Outcome|No Decline During Placebo and IGIV, 10%|Participants who did not experience a relative decrease in grip strength of ≥30% in the less affected hand relative to baseline following IGIV, 10%, and the placebo
1061000|NCT00666263|O3|Outcome|Decline During Both Placebo and IGIV, 10%|Participants who experienced a relative decrease in grip strength of ≥30% in the less affected hand relative to baseline following IGIV, 10%, and the placebo
1061001|NCT00666263|O2|Outcome|Decline Only During Placebo|Participants who experienced a relative decrease in grip strength of ≥30% in the less affected hand relative to baseline following the placebo, but not after IGIV, 10%
1061002|NCT00666263|O1|Outcome|Decline Only During IGIV, 10%|Participants who experienced a relative decrease in grip strength of ≥30% in the less affected hand relative to baseline following IGIV, 10%, but not after the placebo
1061003|NCT00666263|O7|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
1061004|NCT00666263|O6|Outcome|End of Stabilization 3|IGIV, 10%
1061005|NCT00666263|O5|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
1061006|NCT00666263|O4|Outcome|End of Stabilization 2|IGIV, 10%
1061007|NCT00666263|O3|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
1061008|NCT00666263|O2|Outcome|End of Stabilization 1|IGIV, 10% (IGIV)
1061009|NCT00666263|O1|Outcome|Before Stabilization 1|Baseline Measurements
1061049|NCT00666263|O5|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
1061050|NCT00666263|O4|Outcome|End of Stabilization 2|IGIV, 10%
1061010|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1061011|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1061012|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1061013|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1061014|NCT00666263|O7|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
1061015|NCT00666263|O6|Outcome|End of Stabilization 3|IGIV, 10%
1061016|NCT00666263|O5|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
1061017|NCT00666263|O4|Outcome|End of Stabilization 2|IGIV, 10%
1061018|NCT00666263|O3|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
1061019|NCT00666263|O2|Outcome|End of Stabilization 1|IGIV, 10% (IGIV)
1061020|NCT00666263|O1|Outcome|Before Stabilization 1|Baseline Measurements
1061021|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1061022|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1061023|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1061024|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1061051|NCT00666263|O3|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
1061052|NCT00666263|O2|Outcome|End of Stabilization 1|IGIV, 10% (IGIV)
1061032|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1061033|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1061034|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1061035|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1061036|NCT00666263|O7|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
1061037|NCT00666263|O6|Outcome|End of Stabilization 3|IGIV, 10%
1061038|NCT00666263|O5|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
1061039|NCT00666263|O4|Outcome|End of Stabilization 2|IGIV, 10%
1061040|NCT00666263|O3|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
1061041|NCT00666263|O2|Outcome|End of Stabilization 1|IGIV, 10% (IGIV)
1061042|NCT00666263|O1|Outcome|Before Stabilization 1|Baseline Measurements
1061043|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1061044|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1061045|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1061046|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1061053|NCT00666263|O1|Outcome|Before Stabilization 1|Baseline Measurements
1061214|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061054|NCT00666263|O7|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
1061055|NCT00666263|O6|Outcome|End of Stabilization 3|IGIV, 10%
1061056|NCT00666263|O5|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
1061057|NCT00666263|O4|Outcome|End of Stabilization 2|IGIV, 10%
1061058|NCT00666263|O3|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
1061059|NCT00666263|O2|Outcome|End of Stabilization 1|IGIV, 10% (IGIV)
1061060|NCT00666263|O1|Outcome|Before Stabilization 1|Baseline Measurements
1061061|NCT00666263|O6|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
1061062|NCT00666263|O5|Outcome|End of Stabilization 3|(IGIV, 10%)
1061063|NCT00666263|O4|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
1061064|NCT00666263|O3|Outcome|End of Stabilization 2|(IGIV, 10%)
1061065|NCT00666263|O2|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
1061066|NCT00666263|O1|Outcome|End of Stabilization 1|(IGIV, 10%)
1061067|NCT00666263|O4|Outcome|No Accelerated Switch During IGIV, 10% or Placebo|Participants who did not require a switch to open label IGIV, 10% when receiving IGIV, 10%, or placebo
1061068|NCT00666263|O3|Outcome|Accelerated Switch During IGIV, 10%, But Not Placebo|Participants who required a switch to open label IGIV, 10% when receiving IGIV, 10%, but not during placebo
1061069|NCT00666263|O2|Outcome|Accelerated Switch During Placebo, But Not IGIV, 10%|Participants who required a switch to open label IGIV, 10% when receiving the placebo, but not during IGIV, 10%
1061070|NCT00666263|O1|Outcome|Accelerated Switch During IGIV, 10% and Placebo|Participants who required a switch to open label IGIV, 10% when receiving IGIV, 10%, and placebo
1061071|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1061072|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10%- Placebo Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1061073|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1061074|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1061075|NCT00666263|O7|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
1061076|NCT00666263|O6|Outcome|End of Stabilization 3|IGIV, 10%
1061077|NCT00666263|O5|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
1061078|NCT00666263|O4|Outcome|End of Stabilization 2|IGIV, 10%
1061079|NCT00666263|O3|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
1061080|NCT00666263|O2|Outcome|End of Stabilization 1|IGIV, 10% (IGIV)
1061081|NCT00666263|O1|Outcome|Before Stabilization 1|Baseline Measurements
1061082|NCT00666263|O4|Outcome|No Decline During Placebo or IGIV, 10%|Participants who did not experience a relative decrease in grip strength of ≥30% in the more affected hand relative to baseline following IGIV, 10%, and the placebo
1061083|NCT00666263|O3|Outcome|Decline During Both Placebo and IGIV, 10%|Participants who experienced a relative decrease in grip strength of ≥30% in the more affected hand relative to baseline following IGIV, 10%, and the placebo
1061111|NCT00666224|O1|Outcome|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
1061085|NCT00666263|O1|Outcome|Decline Only During IGIV, 10%|Participants who experienced a relative decrease in grip strength of ≥30% in the more affected hand relative to baseline following IGIV, 10%, but not after the placebo
1061086|NCT00666263|O4|Outcome|Arm 2: Placebo Then IGIV, 10% - Crossover Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1061087|NCT00666263|O3|Outcome|Arm 2: Placebo Then IGIV, 10% - Crossover Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1061088|NCT00666263|O2|Outcome|Arm 1: IGIV, 10% Then Placebo- Crossover Period 2|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1061089|NCT00666263|O1|Outcome|Arm 1: IGIV, 10% Then Placebo- Crossover Period 1|Study Part 1: Open-label phase of treatment/stabilization on IGIV, 10% (Stabilization Phase 1) all participants Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1) Study Part 3: Between the two double-blind treatment cross-over periods, participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2) Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2) Study Part 5: Participants received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3)
1061090|NCT00666263|O7|Outcome|End of the Study|Participants returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.
1061091|NCT00666263|O6|Outcome|End of Stabilization 3|IGIV, 10%
1061092|NCT00666263|O5|Outcome|End of Cross-Over 2|Either IGIV, 10% or Placebo. The opposite of the end of Cross-Over 1.
1061093|NCT00666263|O4|Outcome|End of Stabilization 2|IGIV, 10%
1061094|NCT00666263|O3|Outcome|End of Cross-Over 1|Either IGIV, 10% or Placebo
1061095|NCT00666263|O2|Outcome|End of Stabilization 1|IGIV, 10% (IGIV)
1061096|NCT00666263|O1|Outcome|Before Stabilization 1|Baseline Measurements
1061097|NCT00666263|E2|Reported Event|Placebo|0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used)
1061098|NCT00666263|E1|Reported Event|IGIV, 10%|Participants received IGIV, 10% at the same equivalent dose per week administered prior to the study (0.4 to 2.0 g per kg BW per infusion cycle)
1061099|NCT00666224|B3|Baseline|Total|Total of all reporting groups
1061100|NCT00666224|B2|Baseline|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
1061101|NCT00666224|B1|Baseline|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
1061102|NCT00666224|P2|Participant Flow|Placebo (DB) to GA (OL)|Placebo matching glatiramer acetate given once daily by subcutaneous injection during the double-blind period (DB). Following a pre-planned interim analysis, the Data Monitoring Committee (DMC) recommended that the double blind period be closed and participants moved into the Open Label (OL) period. Glatiramer acetate (GA) given 20 mg once daily by subcutaneous injection during the open-label period (OL).
1061103|NCT00666224|P1|Participant Flow|Glatiramer Acetate|Glatiramer acetate (GA) 20 mg once daily by subcutaneous injection during the double-blind period. Following a pre-planned interim analysis, the Data Monitoring Committee (DMC) recommended that the double blind period be closed and participants moved into the Open Label (OL) period. Participants in this treatment arm continued taking glatiramer acetate 20 mg once daily by subcutaneous injection during the open-label (OL) period.
1061104|NCT00666224|O2|Outcome|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
1061105|NCT00666224|O1|Outcome|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
1061106|NCT00666224|O2|Outcome|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
1061107|NCT00666224|O1|Outcome|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
1061108|NCT00666224|O2|Outcome|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
1061109|NCT00666224|O1|Outcome|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
1061110|NCT00666224|O2|Outcome|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
1061211|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061112|NCT00666224|O2|Outcome|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
1061113|NCT00666224|O1|Outcome|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
1061114|NCT00666224|O2|Outcome|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
1061115|NCT00666224|O1|Outcome|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period.
1061116|NCT00666224|E3|Reported Event|Glatiramer Acetate (Entire Study)|Glatiramer acetate (GA) 20 mg once daily by subcutaneous injection. GA adverse experiences from both the double-blind and open-label periods are combined in this column.
1061117|NCT00666224|E2|Reported Event|Glatiramer Acetate (Double-blind Period)|Glatiramer acetate 20 mg once daily by subcutaneous injection during the double-blind period. This subset of the GA treatment experience allows for comparison to the Placebo Double-blind Period data.
1061118|NCT00666224|E1|Reported Event|Placebo (Double-blind Period)|Placebo matching GA once daily by subcutaneous injection during the double-blind period.
1061119|NCT00666211|B3|Baseline|Total|Total of all reporting groups
1061120|NCT00666211|B2|Baseline|Opioid Titration|Pain will be Monitored and Medication Titrated
1061121|NCT00666211|B1|Baseline|Standard of Care|Standard pain control drugs.
1061122|NCT00666211|P2|Participant Flow|Opioid Titration|Pain will be Monitored and Medication Titrated
1061123|NCT00666211|P1|Participant Flow|Standard of Care|Standard pain control drugs.
1061124|NCT00666211|O2|Outcome|Opioid Titration|Pain will be Monitored and Medication Titrated
1061125|NCT00666211|O1|Outcome|Standard of Care|Standard pain control drugs.
1061126|NCT00666211|O2|Outcome|Opioid Titration|Pain will be Monitored and Medication Titrated
1061127|NCT00666211|O1|Outcome|Standard of Care|Standard pain control drugs.
1061128|NCT00666211|O2|Outcome|Opioid Titration|Pain will be Monitored and Medication Titrated
1061129|NCT00666211|O1|Outcome|Standard of Care|Standard pain control drugs.
1061130|NCT00666211|O2|Outcome|Opioid Titration|Pain will be Monitored and Medication Titrated
1061131|NCT00666211|O1|Outcome|Standard of Care|Standard pain control drugs.
1061132|NCT00666211|O2|Outcome|Opioid Titration|Pain will be Monitored and Medication Titrated
1061133|NCT00666211|O1|Outcome|Standard of Care|Standard pain control drugs.
1061134|NCT00666211|O2|Outcome|Opioid Titration|Pain will be Monitored and Medication Titrated
1061135|NCT00666211|O1|Outcome|Standard of Care|Standard pain control drugs.
1061136|NCT00666211|O2|Outcome|Opioid Titration|Pain will be Monitored and Medication Titrated
1061137|NCT00666211|O1|Outcome|Standard of Care|Standard pain control drugs.
1061138|NCT00666211|E2|Reported Event|Opioid Titration|Pain will be Monitored and Medication Titrated
1061139|NCT00666211|E1|Reported Event|Standard of Care|Standard pain control drugs.
1061140|NCT00666198|B1|Baseline|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
1061141|NCT00666198|P1|Participant Flow|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
1061142|NCT00666198|O1|Outcome|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
1061143|NCT00666198|O1|Outcome|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
1061144|NCT00666198|O1|Outcome|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
1061145|NCT00666198|O1|Outcome|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
1061146|NCT00666198|O1|Outcome|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
1061147|NCT00666198|O1|Outcome|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
1061148|NCT00666198|O1|Outcome|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
1061149|NCT00666198|O1|Outcome|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
1061150|NCT00666198|O1|Outcome|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
1061151|NCT00666198|O1|Outcome|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
1061152|NCT00666198|E1|Reported Event|Revatio (Sildenafil Citrate)|Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.
1061153|NCT00666029|B3|Baseline|Total|Total of all reporting groups
1061212|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061213|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061154|NCT00666029|B2|Baseline|Placebo|"Placebo arm dummy pill~placebo: Placebo Age 18-75 years, body mass index (BMI) 20-35 kg/m2, with > 3 criteria for the metabolic syndrome , one of which will be hypertriglyceridaemia, i.e. fasting plasma triglycerides >2.0 mmol/L – a cardinal lipid abnormality of the syndrome."
1061155|NCT00666029|B1|Baseline|Atorvastatin|"Active arm atorvastatin 40 mg. o.d.~atorvastatin: 40 m.g. o.d. tablets for 6 months Age 18-75 years, body mass index (BMI) 20-35 kg/m2, with > 3 criteria for the metabolic syndrome , one of which will be hypertriglyceridaemia, i.e. fasting plasma triglycerides >2.0 mmol/L – a cardinal lipid abnormality of the syndrome."
1061156|NCT00666029|P2|Participant Flow|Placebo|"Placebo arm dummy pill~placebo: Placebo"
1061157|NCT00666029|P1|Participant Flow|Atorvastatin|"Active arm atorvastatin 40 mg. o.d.~Participants randomised to atorvastatin: 40 m.g. o.d. tablets for 6 months"
1061158|NCT00666029|O2|Outcome|Placebo|"Placebo arm dummy pill~placebo: Placebo"
1061159|NCT00666029|O1|Outcome|Atorvastatin|"Active arm atorvastatin 40 mg. o.d.~Participants randomised to atorvastatin: 40 m.g. o.d. tablets for 6 months"
1061160|NCT00666029|O2|Outcome|Placebo|"Placebo arm dummy pill~placebo: Placebo"
1061161|NCT00666029|O1|Outcome|Atorvastatin|"Active arm atorvastatin 40 mg. o.d.~atorvastatin: 40 m.g. o.d. tablets for 6 months"
1061162|NCT00666029|E2|Reported Event|Placebo|"Placebo arm dummy pill~placebo: Placebo"
1061163|NCT00666029|E1|Reported Event|Atorvastatin|"Active arm atorvastatin 40 mg. o.d.~atorvastatin: 40 m.g. o.d. tablets for 6 months"
1061164|NCT00665925|B5|Baseline|Total|Total of all reporting groups
1061165|NCT00665925|B4|Baseline|R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061166|NCT00665925|B3|Baseline|R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061167|NCT00665925|B2|Baseline|Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061168|NCT00665925|B1|Baseline|Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061169|NCT00665925|P4|Participant Flow|R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061170|NCT00665925|P3|Participant Flow|R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061171|NCT00665925|P2|Participant Flow|Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061172|NCT00665925|P1|Participant Flow|Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061173|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061174|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061175|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061176|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061177|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061178|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061179|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061180|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061181|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061182|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061183|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061184|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061185|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061186|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061187|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061188|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061189|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061190|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061191|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061192|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061193|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061194|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061195|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061196|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061197|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061198|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061199|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061200|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061201|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061202|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061203|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061204|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061205|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061206|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061207|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061208|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061209|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061210|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061215|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061216|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061217|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061218|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061219|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061220|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061221|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061222|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061223|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061224|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061225|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061226|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061227|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061228|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061229|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061230|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061231|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061232|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061233|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061234|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061235|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061236|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061237|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061238|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061239|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061240|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061241|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061242|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061243|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061244|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061245|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061246|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061247|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061248|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061249|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061250|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061251|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061252|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061253|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061254|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061255|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061256|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061257|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061258|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061259|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061260|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061261|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061262|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061263|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061264|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061265|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061266|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061267|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061268|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061269|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061270|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061271|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061272|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061273|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061274|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061275|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061277|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061278|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061279|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061280|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061281|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061282|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061283|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061284|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061285|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061286|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061287|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061288|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061289|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061290|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061291|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061292|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061293|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061294|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061295|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061296|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061297|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061298|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061299|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061300|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061301|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061302|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061303|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061304|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061305|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061306|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061307|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061308|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061309|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061310|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061311|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061312|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061313|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061314|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061315|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061316|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061317|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061318|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061319|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061320|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061321|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061322|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061323|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061324|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061325|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061326|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061327|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061328|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061329|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061330|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061331|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061332|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061333|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061334|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061335|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061336|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061337|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061338|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061339|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061340|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061341|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061342|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061343|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061344|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061345|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061346|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061347|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061348|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061349|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061350|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061351|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061352|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061353|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061354|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061355|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061356|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061357|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061358|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061359|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061360|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061361|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061362|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061363|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061364|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061365|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061366|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061367|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061368|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061369|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061370|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061371|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061372|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061373|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061374|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061375|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061376|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061377|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061378|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061379|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061380|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061381|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061382|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061383|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061384|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061385|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061386|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061387|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061388|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061389|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061390|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061391|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061392|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061393|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061394|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061395|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061396|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061397|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061398|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061399|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061400|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061401|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061402|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061403|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061404|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061405|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061406|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061407|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061408|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061409|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061410|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061411|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061412|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061413|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061414|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061415|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061416|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061417|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061418|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061419|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061420|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061421|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061422|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061423|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061424|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061425|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061426|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061427|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061428|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061429|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061430|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061431|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061432|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061433|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061434|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061435|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061436|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061437|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061438|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061439|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061440|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061441|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061442|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061443|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061444|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061445|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061446|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061447|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061448|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061449|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061450|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061451|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061452|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061453|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061454|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061455|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061456|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061457|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061458|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061459|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061460|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061461|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061462|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061463|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061464|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061465|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061466|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061467|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061468|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061469|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061470|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061471|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061472|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061473|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061474|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061475|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061476|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061477|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061478|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061479|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061480|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061481|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061482|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061483|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061484|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061485|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061486|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061487|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061488|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061489|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061490|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061491|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061492|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061493|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061494|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061495|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061496|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061497|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061498|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061499|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061500|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061501|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061502|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061503|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061504|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061505|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061506|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061507|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061508|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061509|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061510|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061511|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061512|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061513|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061514|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061515|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061516|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061517|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061518|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061519|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061520|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061521|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061522|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061523|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061524|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061525|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061526|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061527|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061528|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061529|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061530|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061531|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061532|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061533|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061534|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061535|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061536|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061537|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061538|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061539|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061540|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061541|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061542|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061543|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061544|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061545|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061546|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061547|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061548|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061549|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061550|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061551|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061552|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061553|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061554|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061555|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061556|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061557|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061558|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061559|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061560|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061561|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061562|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061563|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061564|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061565|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061566|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061567|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061568|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061569|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061570|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061571|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061572|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061573|NCT00665925|O5|Outcome|Arm 5 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061574|NCT00665925|O4|Outcome|Arm 4 - R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061575|NCT00665925|O3|Outcome|Arm 3 - Placebo Pooled|Placebo to R788, oral tablets once and twice daily pooled
1061576|NCT00665925|O2|Outcome|Arm 2 - Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061577|NCT00665925|O1|Outcome|Arm 1 - Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061578|NCT00665925|E4|Reported Event|R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061579|NCT00665925|E3|Reported Event|R788 150 mg qd|R788 150 mg, oral tablets, once daily, double-blind
1061580|NCT00665925|E2|Reported Event|Placebo Bid|Placebo to R788, oral tablets, twice daily, double-blind
1061581|NCT00665925|E1|Reported Event|Placebo qd|Placebo to R788, oral tablets, once daily, double-blind
1061582|NCT00665847|B1|Baseline|TMC125|TMC125 dosed according to body weight (kg) from 100 mg to 200 mg twice a day
1061583|NCT00665847|P1|Participant Flow|TMC125|TMC125 dosed according to body weight (kg) from 100 mg to 200 mg twice a day
1061584|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
1061585|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
1061586|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
1061587|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
1061588|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
1061589|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
1061590|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
1061591|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
1061592|NCT00665847|O1|Outcome|TMC125|TMC125 dosed based on body weight (kg) from 100 mg to 200 mg twice a day
1061593|NCT00665847|E1|Reported Event|TMC125|TMC125 dosed according to body weight (kg) from 100 mg to 200 mg twice a day
1061594|NCT00665704|B1|Baseline|Tobacco Tactics Website|"Nine veteran smokers who will pilot test the Tobacco Tactics website~Tobacco Tactics website: Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers"
1061595|NCT00665704|P1|Participant Flow|Tobacco Tactics Website|"Nine veteran smokers who will pilot test the Tobacco Tactics website~Tobacco Tactics website: Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers"
1061596|NCT00665704|O1|Outcome|Tobacco Tactics Website|"Nine veteran smokers who will pilot test the Tobacco Tactics website~Tobacco Tactics website: Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers"
1061597|NCT00665704|O1|Outcome|Tobacco Tactics Website|"Nine veteran smokers who will pilot test the Tobacco Tactics website~Tobacco Tactics website: Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers"
1061598|NCT00665704|E1|Reported Event|Tobacco Tactics Website|"Nine veteran smokers who will pilot test the Tobacco Tactics website~Tobacco Tactics website: Pilot test the Tobacco Tactics website tailored to the needs of veteran smokers"
1061599|NCT00665626|B3|Baseline|Total|Total of all reporting groups
1061600|NCT00665626|B2|Baseline|R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061601|NCT00665626|B1|Baseline|Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061602|NCT00665626|P2|Participant Flow|R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061603|NCT00665626|P1|Participant Flow|Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061604|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061605|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061606|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061607|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061608|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061609|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061610|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061611|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061612|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061613|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061614|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061615|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061616|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061617|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061618|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061619|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061620|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061621|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061622|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061623|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061624|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061625|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061626|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061627|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061628|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061629|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061630|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061631|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061632|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061633|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061634|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061635|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061636|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061637|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061638|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061639|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061640|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061641|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061642|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061643|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061644|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061645|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061646|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061647|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061648|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061649|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061650|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061651|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061652|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061653|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061654|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061655|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061656|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061657|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061658|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061659|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061660|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061661|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061662|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061663|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061664|NCT00665626|O2|Outcome|Arm 2 - R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061665|NCT00665626|O1|Outcome|Arm 1 - Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061666|NCT00665626|E2|Reported Event|R788 100 mg Bid|R788 100 mg, oral tablets, twice daily, double-blind
1061667|NCT00665626|E1|Reported Event|Placebo|Placebo to R788, oral tablets, twice daily, double-blind
1061668|NCT00665470|B3|Baseline|Total|Total of all reporting groups
1061669|NCT00665470|B2|Baseline|Cohort II - Low Dose Aldesleukin|Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
1061670|NCT00665470|B1|Baseline|Cohort I - High Dose Aldesleukin|Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses).
1061671|NCT00665470|P2|Participant Flow|Cohort II - Low Dose Aldesleukin|Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
1061672|NCT00665470|P1|Participant Flow|Cohort I - High Dose Aldesleukin|Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses).
1061673|NCT00665470|O2|Outcome|Cohort II - Low Dose Aldesleukin|Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
1061674|NCT00665470|O1|Outcome|Cohort I - High Dose Aldesleukin|Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses).
1061675|NCT00665470|O2|Outcome|Cohort II - Low Dose Aldesleukin|Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
1061676|NCT00665470|O1|Outcome|Cohort I - High Dose Aldesleukin|Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses).
1061677|NCT00665470|E2|Reported Event|Cohort II - Low Dose Aldesleukin|Beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion, patients receive low-dose aldesleukin subcutaneous (SC) once daily 5 days a week for up to 6 weeks.
1061678|NCT00665470|E1|Reported Event|Cohort I - High Dose Aldesleukin|Patients receive high-dose aldesleukin intravenous (IV) over 15 minutes every 8 hours beginning within 24 hours after peripheral blood lymphocyte (PBL) infusion and continuing for up to 5 days (maximum of 15 doses).
1061679|NCT00665444|B1|Baseline|Aripiprazole|"Aripiprazole~Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic."
1061729|NCT00665431|E1|Reported Event|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
1061730|NCT00665366|B3|Baseline|Total|Total of all reporting groups
1061809|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
1071272|NCT00635804|B9|Baseline|Total|Total of all reporting groups
1063707|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
1061680|NCT00665444|P1|Participant Flow|Aripiprazole|"Aripiprazole~Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic."
1061681|NCT00665444|O1|Outcome|Aripiprazole|"Aripiprazole~Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic."
1061682|NCT00665444|O1|Outcome|Aripiprazole|"Aripiprazole~Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic."
1061683|NCT00665444|E1|Reported Event|Aripiprazole|"Aripiprazole~Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic."
1061684|NCT00665431|B4|Baseline|Total|Total of all reporting groups
1061685|NCT00665431|B3|Baseline|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
1061686|NCT00665431|B2|Baseline|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
1061687|NCT00665431|B1|Baseline|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
1061688|NCT00665431|P3|Participant Flow|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
1061689|NCT00665431|P2|Participant Flow|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
1061690|NCT00665431|P1|Participant Flow|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
1061691|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
1061692|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
1061693|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
1061694|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
1061695|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
1061696|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
1061697|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
1061698|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
1061699|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
1061700|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
1061701|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
1061702|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
1061703|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
1061704|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
1061705|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
1061706|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
1061707|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
1061708|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
1061709|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
1061710|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
1061711|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
1061712|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
1061713|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
1061714|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
1061715|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
1061716|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
1061717|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
1061718|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
1061719|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
1061720|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
1061721|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
1061722|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
1061723|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
1061724|NCT00665431|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
1061725|NCT00665431|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
1061726|NCT00665431|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400: 500 mg naproxen/20 mg esomeprazole
1061727|NCT00665431|E3|Reported Event|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
1061728|NCT00665431|E2|Reported Event|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
1061810|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
1061731|NCT00665366|B2|Baseline|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
1061732|NCT00665366|B1|Baseline|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
1061733|NCT00665366|P2|Participant Flow|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
1061734|NCT00665366|P1|Participant Flow|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
1061735|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
1061736|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
1061737|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
1061738|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
1061739|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
1061740|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
1061741|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
1061742|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
1061743|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
1061744|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
1061745|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
1061746|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
1061767|NCT00665353|O1|Outcome|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
1061811|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
1061747|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
1061748|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
1061749|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
1061750|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
1061751|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
1061752|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
1061753|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
1061754|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
1061755|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
1061756|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
1061757|NCT00665366|O2|Outcome|Aripiprazole + Valproate or Lithium|Participants randomly received aripiprazole as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks. Aripiprazole was provided in 5-, 10-, or 15-mg oral tablets and administered at a starting dose of 5 mg per day for Week 1. For Weeks 2 through 3, the dose was titrated up to 10 mg per day, and for Weeks 4 through 6, the dose increased to 15 mg per day. Flexible doses of either 15 or 30 mg per day were administered for Weeks 7 through 12. If participants were unable to tolerate the dose of 15 mg per day of study drug, the dose was decreased to 10 mg per day for Weeks 7 through 12.
1061758|NCT00665366|O1|Outcome|Placebo + Valproate or Lithium|Participants randomly received placebo (1:1 to study drug) as adjunctive therapy to current ongoing treatment with valproate or lithium for 12 weeks.
1061759|NCT00665366|E2|Reported Event|Placebo|
1061760|NCT00665366|E1|Reported Event|Aripiprazole|
1061761|NCT00665353|B1|Baseline|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
1061762|NCT00665353|P1|Participant Flow|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
1061763|NCT00665353|O1|Outcome|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
1061764|NCT00665353|O1|Outcome|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
1061765|NCT00665353|O1|Outcome|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
1061766|NCT00665353|O1|Outcome|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
1061807|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
1061808|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
1061768|NCT00665353|O1|Outcome|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
1061769|NCT00665353|O1|Outcome|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
1061770|NCT00665353|E1|Reported Event|PIO (Step 1) Then PIO+PEG-INF+RBV (Step 2)|All participants in Step 1 received pioglitazone therapy for 24 to 28 weeks. Participants continued pioglitazone and add peginterferon and ribavirin to their treatment regimen for up to 48 additional weeks in Step 2.
1061771|NCT00665132|B1|Baseline|StimRouter (SR) Active Stimulation|"Percutaneous implantation of StimRouter System~StimRouter System: Implanted with StimRouter System receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)."
1061772|NCT00665132|P1|Participant Flow|StimRouter Stimulation|"Percutaneous implantation of StimRouter System~StimRouter System: Patient is Implanted with StimRouter System lead and receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)."
1061773|NCT00665132|O1|Outcome|StimRouter (SR) Active Stimulation|"Percutaneous implantation of StimRouter System~StimRouter System: Implanted with StimRouter System receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)."
1061774|NCT00665132|O1|Outcome|StimRouter (SR) Active Stimulation|"Percutaneous implantation of StimRouter System~StimRouter System: Implanted with StimRouter System receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)."
1061775|NCT00665132|O1|Outcome|StimRouter (SR) Active Stimulation|"Percutaneous implantation of StimRouter System~StimRouter System: Implanted with StimRouter System receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)."
1061776|NCT00665132|O1|Outcome|StimRouter (SR) Active Stimulation|"Percutaneous implantation of StimRouter System~StimRouter System: Implanted with StimRouter System receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)."
1061777|NCT00665132|E1|Reported Event|StimRouter (SR) Active Stimulation|"Percutaneous implantation of StimRouter System~StimRouter System: Implanted with StimRouter System receive approximately 6 hours of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)."
1061778|NCT00665002|B1|Baseline|Experimental: WT-1 Analog Peptide Vaccine|Participants received 6 bi-weekly vaccinations over 10 weeks. WT-1 vaccine was given with Montanide. Participants also received an injection of Sargramostim (GM-CSF) two days before each vaccination and again on the day of the WT-1 injection at the same spot.
1061779|NCT00665002|P1|Participant Flow|Experimental: WT-1 Analog Peptide Vaccine|Participants received 6 bi-weekly vaccinations over 10 weeks. WT-1 vaccine was given with Montanide. Participants also received an injection of Sargramostim (GM-CSF) two days before each vaccination and again on the day of the WT-1 injection at the same spot.
1061780|NCT00665002|O1|Outcome|Experimental: WT-1 Analog Peptide Vaccine|Participants received 6 bi-weekly vaccinations over 10 weeks. WT-1 vaccine was given with Montanide. Participants also received an injection of Sargramostim (GM-CSF) two days before each vaccination and again on the day of the WT-1 injection at the same spot.
1061781|NCT00665002|O1|Outcome|Experimental: WT-1 Analog Peptide Vaccine|Participants received 6 bi-weekly vaccinations over 10 weeks. WT-1 vaccine was given with Montanide. Participants also received an injection of Sargramostim (GM-CSF) two days before each vaccination and again on the day of the WT-1 injection at the same spot.
1061782|NCT00665002|E1|Reported Event|Experimental: WT-1 Analog Peptide Vaccine|Participants received 6 bi-weekly vaccinations over 10 weeks.
1061783|NCT00664742|B1|Baseline|Fluvastatin XL® Treatment|80 mg once daily, at bedtime.
1061784|NCT00664742|P1|Participant Flow|Fluvastatin XL® Treatment|80 mg once daily, at bedtime.
1061785|NCT00664742|O1|Outcome|Fluvastatin XL® Treatment|80 mg once daily, at bedtime.
1061786|NCT00664742|O1|Outcome|Fluvastatin XL® Treatment|80 mg once daily, at bedtime.
1061787|NCT00664742|E1|Reported Event|Fluvastatin XL® Treatment|80 mg once daily, at bedtime.
1061788|NCT00664560|B4|Baseline|Total|Total of all reporting groups
1061789|NCT00664560|B3|Baseline|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
1061790|NCT00664560|B2|Baseline|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
1061791|NCT00664560|B1|Baseline|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
1061792|NCT00664560|P3|Participant Flow|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
1061793|NCT00664560|P2|Participant Flow|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
1061794|NCT00664560|P1|Participant Flow|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
1061795|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
1061796|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
1061797|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
1061798|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
1061799|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
1061800|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
1061801|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
1061802|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
1061803|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
1061804|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
1061805|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
1061806|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
1061812|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
1061813|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
1061814|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
1061815|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
1061816|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
1061817|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
1061818|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
1061819|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
1061820|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
1061821|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
1061822|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
1061823|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
1061824|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
1061825|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
1061826|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
1061827|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
1061828|NCT00664560|O3|Outcome|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
1061829|NCT00664560|O2|Outcome|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
1061830|NCT00664560|O1|Outcome|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
1061831|NCT00664560|E3|Reported Event|(Placebo Twice Daily)|placebo (sugar pill) dosed twice daily (bid)
1061832|NCT00664560|E2|Reported Event|(Celebrex 200 mg Once Daily)|Celecoxib 200 mg (Celebrex) taken once daily
1061833|NCT00664560|E1|Reported Event|(PN 400 (VIMOVO) Twice Daily)|PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
1061834|NCT00664534|B3|Baseline|Total|Total of all reporting groups
1061835|NCT00664534|B2|Baseline|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
1061836|NCT00664534|B1|Baseline|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
1061837|NCT00664534|P2|Participant Flow|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
1061838|NCT00664534|P1|Participant Flow|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
1061839|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
1061840|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
1061841|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
1061842|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
1061843|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
1061844|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
1061845|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
1061846|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
1061847|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
1061848|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
1061849|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
1061850|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
1061851|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
1061852|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
1061853|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
1061854|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
1061855|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
1061856|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
1061857|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
1061858|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
1061859|NCT00664534|O2|Outcome|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs
1061860|NCT00664534|O1|Outcome|Glargine|Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
1061861|NCT00664534|E2|Reported Event|Glargine|Glargine +/- 1, 2 or 3 injections of insulin lispro plus OAMs
1061862|NCT00664534|E1|Reported Event|Premix Insulin Lispro|Premixed Insulin Lispro (mid-mixture or low-mixture) 1, 2 or 3 injections plus OAMs
1061863|NCT00664521|B3|Baseline|Total|Total of all reporting groups
1061864|NCT00664521|B2|Baseline|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
1062058|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
1061865|NCT00664521|B1|Baseline|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
1061866|NCT00664521|P2|Participant Flow|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
1061867|NCT00664521|P1|Participant Flow|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
1061868|NCT00664521|O2|Outcome|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
1061869|NCT00664521|O1|Outcome|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
1061870|NCT00664521|O2|Outcome|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
1061871|NCT00664521|O1|Outcome|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
1061872|NCT00664521|O2|Outcome|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
1061873|NCT00664521|O1|Outcome|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
1061874|NCT00664521|O2|Outcome|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
1061875|NCT00664521|O1|Outcome|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
1061876|NCT00664521|O2|Outcome|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
1061877|NCT00664521|O1|Outcome|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
1061878|NCT00664521|O2|Outcome|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
1061879|NCT00664521|O1|Outcome|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
1061880|NCT00664521|O2|Outcome|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
1061881|NCT00664521|O1|Outcome|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
1061882|NCT00664521|O2|Outcome|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
1061883|NCT00664521|O1|Outcome|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
1061884|NCT00664521|E2|Reported Event|Rituximab Plus Placebo|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
1061885|NCT00664521|E1|Reported Event|Rituximab Plus Atacicept|Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
1061886|NCT00664430|B1|Baseline|Calcitriol Challenge Followed by Paricalcitol|To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.
1061887|NCT00664430|P1|Participant Flow|Calcitriol Challenge Followed by Paricalcitol|To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.
1061888|NCT00664430|O1|Outcome|Calcitriol Challenge Followed by Paricalcitol|To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.
1061889|NCT00664430|O1|Outcome|Calcitriol Challenge Followed by Paricalcitol|To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.
1061890|NCT00664430|O1|Outcome|Calcitriol Challenge Followed by Paricalcitol|To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.
1061948|NCT00663858|B1|Baseline|Cetrorelix 78+78|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
1061891|NCT00664430|E1|Reported Event|Calcitriol Challenge Followed by Paricalcitol|To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.
1061892|NCT00664326|B1|Baseline|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
1061893|NCT00664326|P1|Participant Flow|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
1061894|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
1061895|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
1061896|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
1061897|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
1061898|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
1061899|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
1061900|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
1061901|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
1061902|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
1061903|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
1061904|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
1061905|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
1061906|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
1061907|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
1061908|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
1061909|NCT00664326|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
1061910|NCT00664326|E1|Reported Event|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
1061911|NCT00664105|B1|Baseline|Chemo-radio Therapy|Patients will receive carboplatin and docetaxel will be given weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
1061912|NCT00664105|P1|Participant Flow|Chemo-radio Therapy|Patients will receive carboplatin and docetaxel will be given weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
1061913|NCT00664105|O1|Outcome|Chemo-radio Therapy|Patients will receive carboplatin and docetaxel weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
1061914|NCT00664105|O1|Outcome|Chemo-radio Therapy|Patients will receive carboplatin and docetaxel weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
1061915|NCT00664105|O1|Outcome|Chemo-radio Therapy|Patients will receive carboplatin and docetaxel weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
1061916|NCT00664105|O1|Outcome|Chemo-radio Therapy|Patients will receive carboplatin and docetaxel will be given weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
1061917|NCT00664105|E1|Reported Event|Chemo-radio Therapy|Patients will receive carboplatin and docetaxel will be given weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
1061918|NCT00664066|B1|Baseline|Dynepo|Epoetin delta dose, dose frequency, route of administration (iv or sc) and duration will be determined by the investigator according to their normal prescribing habits
1061919|NCT00664066|P1|Participant Flow|Dynepo|Epoetin delta dose, dose frequency, route of administration (iv or sc) and duration will be determined by the investigator according to their normal prescribing habits
1061920|NCT00664066|O1|Outcome|Dynepo|Epoetin delta dose, dose frequency, route of administration (iv or sc) and duration will be determined by the investigator according to their normal prescribing habits
1061921|NCT00664066|E1|Reported Event|Dynepo|Epoetin delta dose, dose frequency, route of administration (iv or sc) and duration will be determined by the investigator according to their normal prescribing habits
1061922|NCT00663962|B3|Baseline|Total|Total of all reporting groups
1061923|NCT00663962|B2|Baseline|Placebo|An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8)
1061949|NCT00663858|P3|Participant Flow|Placebo|Placebo on Week 0, 2, 26 and 28.
1061950|NCT00663858|P2|Participant Flow|CET 78+Placebo|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28.
1061924|NCT00663962|B1|Baseline|Pregabalin|"PHASE 1 (N=3) Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.~PHASE 2 (N=4) Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op."
1061925|NCT00663962|P2|Participant Flow|Placebo|An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8)
1061926|NCT00663962|P1|Participant Flow|Pregabalin|"PHASE 1 (N=3) Pregabalin 150mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.~PHASE 2 (N=4) Pregabalin 300mg administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op."
1061927|NCT00663962|O2|Outcome|Placebo|An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8)
1061928|NCT00663962|O1|Outcome|Pregabalin|"Pregabalin 150mg (N=3) administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.~or Pregabalin 300mg (N=4)administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op."
1061929|NCT00663962|E2|Reported Event|Placebo|An identical placebo administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op. (N=8)
1061930|NCT00663962|E1|Reported Event|Pregabalin|"Pregabalin 150mg (N=3) administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op.~or Pregabalin 300mg (N=4)administered one hour prior to surgery and 12 hours after surgery, then continued BID until day 7 post-op."
1061931|NCT00663923|B1|Baseline|Photorefractive Keratectomy( PRK)|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to100 eyes of 50 participants)to undergo PRK by cross-cylinder or conventional(single) approach using Excimer laser.In cross-cylinder method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .In single method the steepest meridian is treated by elliptical ablation to match the flattest meridian.
1061932|NCT00663923|P1|Participant Flow|Photorefractivekeratectomy(PRK)|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 100 eyes of 50 participants)to undergo PRK by cross-cylinder or conventional(single) approach using Excimer laser.In cross-cylinder method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .in single method,the steepest meridian is treated by elliptical ablation to match the flattest meridian.
1061933|NCT00663923|O2|Outcome|Single PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by single approach using Excimer laser.In this method ,the steepest meridian is treated by elliptical ablation to match the flattest meridian.
1061934|NCT00663923|O1|Outcome|Cross-cylinder PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by cross-cylinder approach using Excimer laser.In this method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .
1061935|NCT00663923|O2|Outcome|Single PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by single approach using Excimer laser.In this method ,the steepest meridian is treated by elliptical ablation to match the flattest meridian.
1061936|NCT00663923|O1|Outcome|Cross-cylinder PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by cross-cylinder approach using Excimer laser.In this method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .
1061937|NCT00663923|O2|Outcome|Single PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by single approach using Excimer laser.In this method ,the steepest meridian is treated by elliptical ablation to match the flattest meridian.
1061938|NCT00663923|O1|Outcome|Cross-cylinder PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by cross-cylinder approach using Excimer laser.In this method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .
1061939|NCT00663923|O2|Outcome|Single PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by single approach using Excimer laser.In this method ,the steepest meridian is treated by elliptical ablation to match the flattest meridian.
1061940|NCT00663923|O1|Outcome|Cross-cylinder PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by cross-cylinder approach using Excimer laser.In this method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .
1061941|NCT00663923|O2|Outcome|Single PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by single approach using Excimer laser.In this method ,the steepest meridian is treated by elliptical ablation to match the flattest meridian.
1061942|NCT00663923|O1|Outcome|Cross-cylinder PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by cross-cylinder approach using Excimer laser.In this method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .
1061943|NCT00663923|E2|Reported Event|Single PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by single approach using Excimer laser.In this method ,the steepest meridian is treated by elliptical ablation to match the flattest meridian.
1061944|NCT00663923|E1|Reported Event|Cross-cylinder PRK|Right or left eye of 50 patients was randomly enrolled(data provided in this module refer to 50 eyes of 50 participants)to undergo PRK by cross-cylinder approach using Excimer laser.In this method , half of the cylinder is treated along the steepest meridian and the other half is ablated along the flattest meridian .
1061945|NCT00663858|B4|Baseline|Total|Total of all reporting groups
1061946|NCT00663858|B3|Baseline|Placebo|Placebo on Week 0, 2, 26 and 28.
1061947|NCT00663858|B2|Baseline|CET 78+Placebo|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28.
1071636|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
1061951|NCT00663858|P1|Participant Flow|Cetrorelix 78+78|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
1061952|NCT00663858|O3|Outcome|Placebo|Placebo on Week 0, 2, 26 and 28.
1061953|NCT00663858|O2|Outcome|CET 78+Placebo|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28.
1061954|NCT00663858|O1|Outcome|Cetrorelix 78+78|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
1061955|NCT00663858|E3|Reported Event|Placebo|Placebo on Week 0, 2, 26 and 28.
1061956|NCT00663858|E2|Reported Event|CET 78+Placebo|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28.
1061957|NCT00663858|E1|Reported Event|Cetrorelix 78+78|78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
1061958|NCT00663819|B3|Baseline|Total|Total of all reporting groups
1061959|NCT00663819|B2|Baseline|Procedure/Surgery|"Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement~Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement"
1061960|NCT00663819|B1|Baseline|GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement|"GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers~GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement: Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler"
1061961|NCT00663819|P2|Participant Flow|Procedure/Surgery|"Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement~Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement"
1061962|NCT00663819|P1|Participant Flow|Device|"GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers~GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement: Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler"
1061963|NCT00663819|O2|Outcome|Procedure/Surgery|"Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement~Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement"
1061964|NCT00663819|O1|Outcome|Device|"GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers~GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement: Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler"
1061965|NCT00663819|E2|Reported Event|Procedure/Surgery|"Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement~Staple line without reinforcement: colorectal and coloanal anastomotic staple line without reinforcement"
1061966|NCT00663819|E1|Reported Event|GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement|"GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers~GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement: Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler"
1061967|NCT00663793|B3|Baseline|Total|Total of all reporting groups
1061968|NCT00663793|B2|Baseline|Testosterone Plus Finasteride|"(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
1061969|NCT00663793|B1|Baseline|Testosterone Only|"(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
1061970|NCT00663793|P2|Participant Flow|Testosterone Plus Finasteride|"(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
1061971|NCT00663793|P1|Participant Flow|Testosterone Only|"(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
1061972|NCT00663793|O2|Outcome|Testosterone Plus Finasteride|"(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
1061973|NCT00663793|O1|Outcome|Testosterone Only|"(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
1062059|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
1061974|NCT00663793|O2|Outcome|Testosterone Plus Finasteride|"(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
1061975|NCT00663793|O1|Outcome|Testosterone Only|"(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
1061976|NCT00663793|O2|Outcome|Testosterone Plus Finasteride|"(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
1061977|NCT00663793|O1|Outcome|Testosterone Only|"(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
1061978|NCT00663793|E2|Reported Event|Testosterone Plus Finasteride|"(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
1061979|NCT00663793|E1|Reported Event|Testosterone Only|"(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once."
1061980|NCT00663702|B3|Baseline|Total|Total of all reporting groups
1061981|NCT00663702|B2|Baseline|Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
1061982|NCT00663702|B1|Baseline|Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or BMS IM101-029), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
1061983|NCT00663702|P2|Participant Flow|Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
1061984|NCT00663702|P1|Participant Flow|Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb [BMS] IM101-029), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
1061985|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
1061986|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
1061987|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
1062022|NCT00663260|P1|Participant Flow|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label anti-diabetic therapy as rescue)
1061988|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
1061989|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
1061990|NCT00663702|O2|Outcome|Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
1061991|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb [BMS] IM101-029), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
1061992|NCT00663702|O2|Outcome|Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
1061993|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb [BMS] IM101-029), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
1061994|NCT00663702|O2|Outcome|Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
1061995|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb [BMS] IM101-029), received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
1061996|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
1061997|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
1061998|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
1061999|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
1062000|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
1062001|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
1062002|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
1062003|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
1062004|NCT00663702|O1|Outcome|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
1062005|NCT00663702|E1|Reported Event|Subcutaneous Abatacept, 125 mg|Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor or showed an inadequate response to treatment with methotrexate in an earlier study, received subcutaneous abatacept, 125 mg, once weekly. Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
1062006|NCT00663403|B1|Baseline|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
1062007|NCT00663403|P1|Participant Flow|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
1062008|NCT00663403|O1|Outcome|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
1062009|NCT00663403|O1|Outcome|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
1062010|NCT00663403|O1|Outcome|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
1062011|NCT00663403|O1|Outcome|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
1062012|NCT00663403|O1|Outcome|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
1062013|NCT00663403|O1|Outcome|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
1062014|NCT00663403|O1|Outcome|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
1062015|NCT00663403|E1|Reported Event|Daptomycin in Continuous Renal Replacement Therapy (CRRT)|This is a single arm study. Critically ill study subjects receiving continuous venovenous hemodialysis and prescribed daptomycin will receive daptomycin 8 mg/kg IV every 48 hours. Serial serum and effluent samples will be collected over 48 hours to assess daptomycin transmembrane clearance and pharmacokinetics during continuous venovenous hemodialysis.
1062016|NCT00663260|B4|Baseline|Total|Total of all reporting groups
1062017|NCT00663260|B3|Baseline|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
1062018|NCT00663260|B2|Baseline|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
1062019|NCT00663260|B1|Baseline|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label anti-diabetic therapy as rescue)
1062020|NCT00663260|P3|Participant Flow|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
1062021|NCT00663260|P2|Participant Flow|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
1062057|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
1062023|NCT00663260|O3|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
1062024|NCT00663260|O2|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
1062025|NCT00663260|O1|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label anti-diabetic therapy as rescue)
1062026|NCT00663260|O3|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
1062027|NCT00663260|O2|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
1062028|NCT00663260|O1|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label anti-diabetic therapy as rescue)
1062029|NCT00663260|O3|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
1062030|NCT00663260|O2|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
1062031|NCT00663260|O1|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label anti-diabetic therapy as rescue)
1062032|NCT00663260|E3|Reported Event|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
1062033|NCT00663260|E2|Reported Event|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue)
1062034|NCT00663260|E1|Reported Event|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label anti-diabetic therapy as rescue)
1062035|NCT00663234|B1|Baseline|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
1062036|NCT00663234|P1|Participant Flow|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage starts at 10 mg and is increased to 20 mg at week 8 if efficacy criteria is not met at week 4.
1062037|NCT00663234|O2|Outcome|15 to 23 Years Old|"Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen~Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria."
1062038|NCT00663234|O1|Outcome|10 to 14 Years Old|"Participants ages 10 to 14 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen~Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria."
1062039|NCT00663234|O2|Outcome|15 to 23 Years Old|"Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen~Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria."
1062040|NCT00663234|O1|Outcome|10 to 14 Years Old|"Participants ages 10 to 14 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen~Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria."
1062041|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
1062042|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
1062043|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
1062044|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
1062045|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
1062046|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
1062047|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
1062048|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
1062049|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
1062050|NCT00663234|O2|Outcome|NNRTI-unexposed|Participant was not on at least one non-nucleoside reverse transcriptase inhibitor (NNRTI) at entry.
1062051|NCT00663234|O1|Outcome|NNRTI-exposed|Participant was on at least one non-nucleoside reverse transcriptase inhibitor (NNRTI) at entry.
1062052|NCT00663234|O2|Outcome|15 to 23 Years Old|"Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen~Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria."
1062053|NCT00663234|O1|Outcome|10 to 14 Years Old|"Participants ages 10 to 14 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen~Atorvastatin: 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria."
1062054|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
1062055|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
1062056|NCT00663234|O1|Outcome|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
1062060|NCT00663234|E1|Reported Event|Atorvastatin|10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
1062061|NCT00663208|B8|Baseline|Total|Total of all reporting groups
1062062|NCT00663208|B7|Baseline|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
1062063|NCT00663208|B6|Baseline|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062064|NCT00663208|B5|Baseline|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062065|NCT00663208|B4|Baseline|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062066|NCT00663208|B3|Baseline|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062067|NCT00663208|B2|Baseline|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062068|NCT00663208|B1|Baseline|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062069|NCT00663208|P7|Participant Flow|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
1062070|NCT00663208|P6|Participant Flow|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062071|NCT00663208|P5|Participant Flow|Daclatasvir (30 mg) BID|Participants received twice daily (BID) dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062072|NCT00663208|P4|Participant Flow|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062073|NCT00663208|P3|Participant Flow|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062074|NCT00663208|P2|Participant Flow|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062075|NCT00663208|P1|Participant Flow|Daclatasvir (1 mg) QD|Participants received once daily (QD) dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062076|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
1062077|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062078|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062079|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062080|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062081|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062082|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062083|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
1062084|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062085|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062086|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062087|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062088|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062089|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062090|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
1062256|NCT00663117|O1|Outcome|Placebo|Subjects who received placebo for 3 months
1062091|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062092|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062093|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062094|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062095|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062096|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062097|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
1062098|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062099|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062100|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062101|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062102|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062103|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062104|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
1062105|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062106|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062107|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062108|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062109|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062110|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062111|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
1062112|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062113|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062114|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062115|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062116|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062117|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062118|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
1062119|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062120|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062257|NCT00663117|O2|Outcome|Naltrexone 4.5 mg|naltrexone 4.5 mg for 12 weeks blinded followed by naltrexone 4.5 mg open labeled
1062121|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062122|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062123|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062124|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062125|NCT00663208|O1|Outcome|All Daclatasvir Treated Participants|All participants who received daclatasvir during 14 day treatment period.
1062126|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062127|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062128|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062129|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062130|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062131|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062132|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062133|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062134|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062135|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062136|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062137|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062138|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062139|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062140|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062141|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062142|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062143|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062144|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062145|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062146|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062147|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062148|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062149|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062150|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062151|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1073204|NCT00631969|B3|Baseline|Total|Total of all reporting groups
1062152|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062153|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062154|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062155|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062156|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062157|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062158|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062159|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062160|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062161|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062162|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062163|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062164|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062165|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062166|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062167|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062168|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
1062169|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062170|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062171|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062172|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062173|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062174|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062175|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
1062176|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062177|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062178|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062179|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062180|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062181|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062254|NCT00663117|P1|Participant Flow|Placebo Then Naltrexone 4.5 mg Daily|Subjects will receive placebo for 3 months then be crossed over to active drug for an additional 3 months
1062182|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
1062183|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062184|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062185|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062186|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062187|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062188|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062189|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
1062190|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062191|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062192|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062193|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062194|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062195|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062196|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
1062197|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062198|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062199|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182..
1062200|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062201|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062202|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062203|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
1062204|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062205|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062206|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062207|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062208|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062209|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062210|NCT00663208|O7|Outcome|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
1062211|NCT00663208|O6|Outcome|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062255|NCT00663117|O2|Outcome|Naltrexone 4.5 mg po Daily|Subjects who received naltrexone 4.5 mg by mouth once a day for 3 months
1062212|NCT00663208|O5|Outcome|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062213|NCT00663208|O4|Outcome|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062214|NCT00663208|O3|Outcome|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062215|NCT00663208|O2|Outcome|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062216|NCT00663208|O1|Outcome|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062217|NCT00663208|E7|Reported Event|Placebo|Participants received QD/BID dose of placebo matched to daclatasvir during 14 day treatment period. Participants who received placebo were discharged after Day 28 and after unblinding of the dose panel.
1062218|NCT00663208|E6|Reported Event|Daclatasvir (60 mg) QD|Participants received QD dose of daclatasvir 60 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062219|NCT00663208|E5|Reported Event|Daclatasvir (30 mg) QD|Participants received QD dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062220|NCT00663208|E4|Reported Event|Daclatasvir (30 mg) BID|Participants received BID dose of daclatasvir 30 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062221|NCT00663208|E3|Reported Event|Daclatasvir (100 mg) QD|Participants received QD dose of daclatasvir 100 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062222|NCT00663208|E2|Reported Event|Daclatasvir (10 mg) QD|Participants received QD dose of daclatasvir 10 mg during 14 day treatment period. Participants who received daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062223|NCT00663208|E1|Reported Event|Daclatasvir (1 mg) QD|Participants received QD dose of daclatasvir 1 mg during 14 day treatment period. Participants who received Daclatasvir were followed up at Day 28, Day 42, Day 98 and Day 182.
1062224|NCT00663169|B3|Baseline|Total|Total of all reporting groups
1062225|NCT00663169|B2|Baseline|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
1062226|NCT00663169|B1|Baseline|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
1062227|NCT00663169|P2|Participant Flow|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
1062228|NCT00663169|P1|Participant Flow|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
1062229|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
1062230|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
1062231|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
1062232|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
1062233|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
1062234|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
1062235|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
1062236|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
1062237|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
1062238|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
1062239|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
1062240|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
1062241|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
1062242|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
1062243|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
1062244|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
1062245|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
1062246|NCT00663169|O2|Outcome|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
1062247|NCT00663169|O1|Outcome|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
1062248|NCT00663169|E2|Reported Event|Dexamethasone|Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
1062249|NCT00663169|E1|Reported Event|Canakinumab|Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
1062250|NCT00663117|B3|Baseline|Total|Total of all reporting groups
1062251|NCT00663117|B2|Baseline|Naltrexone 4.5 mg po Daily|Group 2 will receive naltrexone 4.5 mg by mouth once a day for 6 months
1062252|NCT00663117|B1|Baseline|Placebo Daily|Subjects will receive placebo for 3 months then be crossed over to active drug for an additional 3 months
1062253|NCT00663117|P2|Participant Flow|Naltrexone Then Naltrexone 4.5 mg po Daily|Group 2 will receive naltrexone 4.5 mg by mouth once a day for 6 months
1062258|NCT00663117|O1|Outcome|Placebo|Placebo for 12 weeks blinded followed by naltrexone 4.5mg open labeled
1062259|NCT00663117|O2|Outcome|Naltrexone 4.5 mg po Daily|Quality of life on naltrexone treatment 12 weeks
1062260|NCT00663117|O1|Outcome|Placebo|Quality of life in subjects on placebo treatment for 12 weeks
1062261|NCT00663117|O2|Outcome|Naltrexone 4.5 mg po Daily|Naltrexone treated subjects for 12 weeks were analyzed for the percentage that achieved the primary outcome of a 70-point decline in the CDAI score from Baseline values
1062262|NCT00663117|O1|Outcome|Placebo|Placebo treated subjects for 12 weeks were analyzed for the percentage that achieved the primary outcome of a 70-point decline in the CDAI score from Baseline values
1062263|NCT00663117|E2|Reported Event|Naltrexone 4.5 mg|All participants who received naltrexone either for 12 or 24 weeks.
1062264|NCT00663117|E1|Reported Event|Placebo|Participants who received placebo for the first 12 weeks.
1062265|NCT00663052|B3|Baseline|Total|Total of all reporting groups
1062266|NCT00663052|B2|Baseline|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062267|NCT00663052|B1|Baseline|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062268|NCT00663052|P2|Participant Flow|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062269|NCT00663052|P1|Participant Flow|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062270|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062271|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062272|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062273|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062274|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062275|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062276|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062277|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062278|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062279|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062280|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062281|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062282|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062283|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062284|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062285|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062286|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062287|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062288|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062289|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062290|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062291|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062292|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062364|NCT00663026|O1|Outcome|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
1062293|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062294|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062295|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062296|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062297|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062298|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062299|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062300|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062301|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062302|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062303|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062304|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062305|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062306|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062307|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062308|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062309|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062310|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062311|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062312|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062313|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062314|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062315|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062316|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062317|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062318|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062319|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062320|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062321|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062322|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062323|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062324|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062365|NCT00663026|O2|Outcome|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
1062325|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062326|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062327|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062328|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062329|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062330|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062331|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062332|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062333|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062334|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062335|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062336|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062337|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062338|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062339|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062340|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062341|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062342|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062343|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062344|NCT00663052|O2|Outcome|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062345|NCT00663052|O1|Outcome|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062346|NCT00663052|E2|Reported Event|ETN 50 mg QW/QW|ETN s.c. 50 mg QW and matching placebo for ETN QW for 12 weeks (double blind phase), followed by ETN s.c. 50 mg QW for 12 weeks (open label phase).
1062347|NCT00663052|E1|Reported Event|ETN 50 mg BW/QW|Etanercept (ETN) subcutaneously (s.c.) 50 milligram (mg) twice weekly (BIW) for 12 weeks (double blind phase) followed by ETN s.c. 50 mg once weekly (QW) for 12 weeks (open label Phase).
1062348|NCT00663026|B4|Baseline|Total|Total of all reporting groups
1062349|NCT00663026|B3|Baseline|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
1062350|NCT00663026|B2|Baseline|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
1062351|NCT00663026|B1|Baseline|Placebo|Placebo matched to bapineuzumab subcutaneous injection once weekly for 6 months.
1062352|NCT00663026|P3|Participant Flow|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
1062353|NCT00663026|P2|Participant Flow|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
1062354|NCT00663026|P1|Participant Flow|Placebo|Placebo matched to bapineuzumab subcutaneous injection once weekly for 6 months.
1062355|NCT00663026|O2|Outcome|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
1062356|NCT00663026|O1|Outcome|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
1062357|NCT00663026|O2|Outcome|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
1062358|NCT00663026|O1|Outcome|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
1062359|NCT00663026|O2|Outcome|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
1062360|NCT00663026|O1|Outcome|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
1062361|NCT00663026|O2|Outcome|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
1062362|NCT00663026|O1|Outcome|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
1062363|NCT00663026|O2|Outcome|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
1062366|NCT00663026|O1|Outcome|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
1062367|NCT00663026|O3|Outcome|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
1062368|NCT00663026|O2|Outcome|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
1062369|NCT00663026|O1|Outcome|Placebo|Placebo matched to bapineuzumab subcutaneous injection once weekly for 6 months.
1062370|NCT00663026|E3|Reported Event|Bapineuzumab 10 mg|Bapineuzumab 10 mg subcutaneous injection once weekly for 6 months.
1062371|NCT00663026|E2|Reported Event|Bapineuzumab 5 mg|Bapineuzumab 5 milligram (mg) subcutaneous injection once weekly for 6 months.
1062372|NCT00663026|E1|Reported Event|Placebo|Placebo matched to bapineuzumab subcutaneous injection once weekly for 6 months.
1062373|NCT00662909|B4|Baseline|Total|Total of all reporting groups
1062374|NCT00662909|B3|Baseline|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062375|NCT00662909|B2|Baseline|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062376|NCT00662909|B1|Baseline|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062377|NCT00662909|P3|Participant Flow|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062378|NCT00662909|P2|Participant Flow|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062379|NCT00662909|P1|Participant Flow|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062380|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062381|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062382|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062383|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062384|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062385|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062386|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062387|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062388|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062389|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062390|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062391|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062392|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062393|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062394|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062395|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062396|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062397|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062398|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062399|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062400|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062401|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062402|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062403|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062404|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062405|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062406|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062407|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062408|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062409|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062410|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062411|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062412|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062413|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062414|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062415|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062416|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062417|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062418|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062419|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062420|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062421|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062422|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062423|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062424|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062425|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062426|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062427|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062428|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062429|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062430|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062431|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062432|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062433|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062434|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062435|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062436|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062437|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062438|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062439|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062440|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062441|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062442|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062443|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062444|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062445|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062446|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062447|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062448|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062449|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062450|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062451|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062452|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062453|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062454|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062455|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062456|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062457|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062458|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062459|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062460|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062461|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062462|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062463|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062464|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062465|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062466|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062467|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062468|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062469|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062470|NCT00662909|O3|Outcome|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062471|NCT00662909|O2|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062472|NCT00662909|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062473|NCT00662909|E3|Reported Event|Mirabegron 100 mg|Participants received mirabegron 100 mg tablets, orally once a day for 12 weeks
1062474|NCT00662909|E2|Reported Event|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks
1062475|NCT00662909|E1|Reported Event|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks
1062476|NCT00662857|B1|Baseline|Safety Population|Any subject that received at least one treatment with TI inhalation powder
1062477|NCT00662857|P2|Participant Flow|TI - B (1x30 U)/TI - A (2x15 U)/10 U sc Insulin Lispro|Treatment sequence: 30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose, followed by 30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose, and then 10 U of insulin lispro administered subcutaneously (sc) during a glucose clamp procedure
1062478|NCT00662857|P1|Participant Flow|TI - A (2x15 U)/TI - B (1x30 U)/10 U sc Insulin Lispro|Treatment sequence: 30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose, followed by 30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose, and then 10 U of insulin lispro administered subcutaneously (sc) during a glucose clamp procedure
1062479|NCT00662857|O2|Outcome|10 U Subcutaneous (sc) Insulin Lispro|10 U of insulin lispro administered subcutaneously during a glucose clamp procedure
1062480|NCT00662857|O1|Outcome|Techosphere Insulin - B (1 x 30 U)|30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose during a glucose clamp procedure
1062481|NCT00662857|O2|Outcome|Techosphere Insulin - B (1 x 30 U)|30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose during a glucose clamp procedure
1062482|NCT00662857|O1|Outcome|Techosphere Insulin - A (2 x 15 U)|30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose during a glucose clamp procedure
1062483|NCT00662857|O2|Outcome|Techosphere Insulin - B (1 x 30 U)|30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose during a glucose clamp procedure
1062484|NCT00662857|O1|Outcome|Techosphere Insulin - A (2 x 15 U)|30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose during a glucose clamp procedure
1062485|NCT00662857|O2|Outcome|Techosphere Insulin - B (1 x 30 U)|30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose during a glucose clamp procedure
1062486|NCT00662857|O1|Outcome|Techosphere Insulin - A (2 x 15 U)|30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose during a glucose clamp procedure
1062487|NCT00662857|E3|Reported Event|10 U Subcutaneous (sc) Insulin Lispro|10 U of insulin lispro administered subcutaneously during a glucose clamp procedure
1062488|NCT00662857|E2|Reported Event|Techosphere Insulin - B (1 x 30 U)|30 U of Technosphere Insulin (TI) administered as 1 x 30 U cartridges as a single-dose during a glucose clamp procedure
1062489|NCT00662857|E1|Reported Event|Techosphere Insulin - A (2 x 15 U)|30 U of Technosphere Insulin (TI) administered as 2 x 15 U cartridges as a single-dose during a glucose clamp procedure
1062490|NCT00662831|B3|Baseline|Total|Total of all reporting groups
1062491|NCT00662831|B2|Baseline|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
1062492|NCT00662831|B1|Baseline|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
1062493|NCT00662831|P2|Participant Flow|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
1062494|NCT00662831|P1|Participant Flow|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 milliliter [mL]) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
1062495|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
1062496|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
1062497|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
1062498|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
1062499|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
1062500|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
1062501|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
1062502|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
1062503|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
1062504|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
1062505|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
1062506|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
1062507|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
1062508|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
1062509|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
1062510|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
1062511|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
1062512|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
1062513|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
1062564|NCT00662675|O1|Outcome|Placebo|Matching placebo capsules taken by mouth per meal or snack
1062514|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
1062515|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
1062516|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
1062517|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
1062518|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
1062519|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
1062520|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
1062521|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
1062522|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
1062523|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
1062524|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
1062525|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
1062526|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
1062527|NCT00662831|O2|Outcome|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
1062528|NCT00662831|O1|Outcome|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
1062529|NCT00662831|E2|Reported Event|Placebo|Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
1062530|NCT00662831|E1|Reported Event|Dalteparin|Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
1062531|NCT00662818|B3|Baseline|Total|Total of all reporting groups
1062532|NCT00662818|B2|Baseline|Placebo and APAP 1000 mg→Telcagepant 300 mg|Participants receive 1 dose of placebo to APAP and placebo to telcagepant for the first migraine attack and then up to 11 doses of APAP and placebo to telcagepant for up to 11 migraine attacks in Period 1 (6 weeks). Participants receive up to 12 doses of telcagepant and placebo to APAP for up to 12 migraine attacks in Period 2 (6 weeks).
1062533|NCT00662818|B1|Baseline|Telcagepant 300 mg→APAP 1000 mg|Participants receive up to 12 doses of telcagepant (280 mg tablet/capsule 300 mg), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up to 12 migraine attacks in Period 2 (6 weeks).
1062534|NCT00662818|P2|Participant Flow|Placebo and APAP 1000 mg→Telcagepant 300 mg|Participants receive 1 dose of placebo to APAP and placebo to telcagepant for the first migraine attack and then up to 11 doses of APAP and placebo to telcagepant for up to 11 migraine attacks in Period 1 (6 weeks). Participants receive up to 12 doses of telcagepant and placebo to APAP for up to 12 migraine attacks in Period 2 (6 weeks).
1062535|NCT00662818|P1|Participant Flow|Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg|Participants receive up to 12 doses of telcagepant (300 mg capsule/280 mg tablet), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up to 12 migraine attacks in Period 2 (6 weeks).
1062536|NCT00662818|O2|Outcome|Placebo|Participants receiving placebo
1062537|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
1062538|NCT00662818|O2|Outcome|Placebo|Participants receiving placebo
1062539|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
1062540|NCT00662818|O2|Outcome|Placebo|Participants receiving placebo
1062541|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
1062542|NCT00662818|O2|Outcome|Placebo|Participants receiving placebo
1062543|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
1062544|NCT00662818|O2|Outcome|APAP|Participants receiving APAP
1062545|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
1062546|NCT00662818|O2|Outcome|APAP|Participants receiving APAP
1062547|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
1062548|NCT00662818|O2|Outcome|Acetaminophen/Paracetamol (APAP)|Participants receiving APAP
1062549|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
1062550|NCT00662818|O2|Outcome|Placebo|Participants receiving placebo
1062551|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
1062552|NCT00662818|O2|Outcome|Placebo|Participants receiving placebo
1062553|NCT00662818|O1|Outcome|Telcagepant 300 mg|Participants receiving telcagepant
1062554|NCT00662818|E2|Reported Event|Acetaminophen/Paracetamol|Participants receiving acetaminophen/paracetamol
1062555|NCT00662818|E1|Reported Event|Telcagepant|Participants receiving telcagepant
1062556|NCT00662675|B3|Baseline|Total|Total of all reporting groups
1062557|NCT00662675|B2|Baseline|PANCREASE MT|Pancrease MT 10.5 or MT 21 capsules taken by mouth per meal or snack
1062558|NCT00662675|B1|Baseline|Placebo|Matching placebo capsules taken by mouth per meal or snack
1062559|NCT00662675|P2|Participant Flow|PANCREASE MT|Pancrease MT 10.5 or MT 21 capsules taken by mouth per meal or snack
1062560|NCT00662675|P1|Participant Flow|Placebo|Matching placebo capsules taken by mouth per meal or snack
1062561|NCT00662675|O2|Outcome|PANCREASE MT|Pancrease MT 10.5 or MT 21 capsules taken by mouth per meal or snack
1062562|NCT00662675|O1|Outcome|Placebo|Matching placebo capsules taken by mouth per meal or snack
1062563|NCT00662675|O2|Outcome|PANCREASE MT|Pancrease MT 10.5 or MT 21 capsules taken by mouth per meal or snack
1062565|NCT00662675|O2|Outcome|PANCREASE MT|Pancrease MT 10.5 or MT 21 capsules taken by mouth per meal or snack
1062566|NCT00662675|O1|Outcome|Placebo|Matching placebo capsules taken by mouth per meal or snack
1062567|NCT00662675|E2|Reported Event|PANCREASE MT|Pancrease MT 10.5 or MT 21 capsules taken by mouth per meal or snack
1062568|NCT00662675|E1|Reported Event|Placebo|Matching placebo capsules taken by mouth per meal or snack
1062569|NCT00662649|B5|Baseline|Total|Total of all reporting groups
1062570|NCT00662649|B4|Baseline|Placebo-fingolimod 0.5 mg|Patients randomized to placebo in the core study were re randomized to fingolimod 0.5 mg/day in this extension study.
1062571|NCT00662649|B3|Baseline|Placebo-fingolimod 1.25 mg|Patients randomized to placebo in the core study were re randomized to fingolimod 1.25 mg/day in this extension study.
1062572|NCT00662649|B2|Baseline|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
1062573|NCT00662649|B1|Baseline|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
1062574|NCT00662649|P5|Participant Flow|Placebo-fingolimod 0.5|Patients randomized to placebo in the core study were re randomized to fingolimod 0.5 mg/day in this extension study.
1062575|NCT00662649|P4|Participant Flow|Placebo-fingolimod 1.25 mg|Patients randomized to placebo in the core study were re randomized to fingolimod 1.25 mg/day in this extension study.
1062576|NCT00662649|P3|Participant Flow|Placebo|Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod(either 1.25 or 0.5 mg/day) in the Extension study.
1062577|NCT00662649|P2|Participant Flow|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
1062578|NCT00662649|P1|Participant Flow|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
1062579|NCT00662649|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod(either 1.25 or 0.5 mg/day) in the Extension study.
1062580|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
1062581|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
1062582|NCT00662649|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod (either 1.25 or 0.5 mg/day) in the Extension study.
1062583|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
1062584|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
1062585|NCT00662649|O4|Outcome|Placebo-fingolimod 0.5 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 0.5 mg/day in this extension study.
1062586|NCT00662649|O3|Outcome|Placebo-fingolimod 1.25 mg|Patients randomized to placebo in the Core study were re-randomized to fingolimod 1.25 mg/day in this extension study.
1062587|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
1062588|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
1062589|NCT00662649|O4|Outcome|Placebo-fingolimod 0.5 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 0.5 mg/day in this extension study.
1062590|NCT00662649|O3|Outcome|Placebo-fingolimod 1.25 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 1.25 mg/day in this extension study.
1062591|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
1062592|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
1062593|NCT00662649|O4|Outcome|Placebo-fingolimod 0.5 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 0.5 mg/day in this extension study.
1062594|NCT00662649|O3|Outcome|Placebo-fingolimod 1.25 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 1.25 mg/day in this extension study.
1062595|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
1062596|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
1062597|NCT00662649|O4|Outcome|Placebo-fingolimod 0.5 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 0.5 mg/day in this extension study.
1062598|NCT00662649|O3|Outcome|Placebo-fingolimod 1.25 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 1.25 mg/day in this extension study.
1062599|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
1062600|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
1062601|NCT00662649|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study who were subsequently re-randomized to FTY720 (either 1.25 or 0.5 mg/day) in the Extension study.
1062602|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
1062603|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
1062931|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
1062604|NCT00662649|O4|Outcome|Placebo-fingolimod 0.5 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 0.5 mg/day in this extension study.
1062605|NCT00662649|O3|Outcome|Placebo-fingolimod 1.25 mg|Patients randomized to placebo in the core study were re-randomized to fingolimod 1.25 mg/day in this extension study.
1062606|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
1062607|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
1062608|NCT00662649|O3|Outcome|Placebo-fingolimod|Patients randomized to placebo in the Core study who were subsequently re-randomized to FTY720 (either 1.25 or 0.5 mg/day) in the Extension study.
1062609|NCT00662649|O2|Outcome|Fingolimod 0.5 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
1062610|NCT00662649|O1|Outcome|Fingolimod 1.25 mg|Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
1062611|NCT00662649|E4|Reported Event|Placebo-Fingolimod 0.5mg|Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod 0.5 mg/day in the Extension study.
1062612|NCT00662649|E3|Reported Event|Placebo-Fingolimod 1.25mg|Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod 1.25 mg/day in the Extension study.
1062613|NCT00662649|E2|Reported Event|Fingolimod 0.5mg|Patients randomized to fingolimod 0.5 mg/day in the Core study. These patients continued the same dose in the Extension study.
1062614|NCT00662649|E1|Reported Event|Fingolimod 1.25mg|Patients randomized to fingolimod 1.25 mg/day in the Core study. These patients continued the same dose in the Extension study.
1062615|NCT00662558|B3|Baseline|Total|Total of all reporting groups
1062616|NCT00662558|B2|Baseline|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
1062617|NCT00662558|B1|Baseline|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
1062618|NCT00662558|P2|Participant Flow|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
1062619|NCT00662558|P1|Participant Flow|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
1062620|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
1062621|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
1062622|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
1062623|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
1062624|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
1062625|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
1062626|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
1062627|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
1062628|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
1062629|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
1062630|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
1062631|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
1062632|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
1062633|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
1062634|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
1062635|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
1062636|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
1062637|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
1062638|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
1062639|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
1062640|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
1062641|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
1062642|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
1062643|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
1062644|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
1062645|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
1062646|NCT00662558|O2|Outcome|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
1062647|NCT00662558|O1|Outcome|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
1062648|NCT00662558|E2|Reported Event|Tramadol HCL|50 mg capsules four times a day (QID) for 6 weeks
1062649|NCT00662558|E1|Reported Event|Celecoxib|200 mg capsules two times a day (BID) for 6 weeks
1062650|NCT00662545|B3|Baseline|Total|Total of all reporting groups
1062651|NCT00662545|B2|Baseline|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
1062652|NCT00662545|B1|Baseline|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
1062653|NCT00662545|P2|Participant Flow|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
1062654|NCT00662545|P1|Participant Flow|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
1062655|NCT00662545|O2|Outcome|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
1062656|NCT00662545|O1|Outcome|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
1063358|NCT00660829|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
1062657|NCT00662545|O2|Outcome|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
1062658|NCT00662545|O1|Outcome|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
1062659|NCT00662545|O2|Outcome|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
1062660|NCT00662545|O1|Outcome|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
1062661|NCT00662545|O2|Outcome|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
1062662|NCT00662545|O1|Outcome|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
1062663|NCT00662545|O2|Outcome|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
1062664|NCT00662545|O1|Outcome|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
1062665|NCT00662545|E2|Reported Event|Standard of Care|continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
1062666|NCT00662545|E1|Reported Event|Entecavir Intensification|Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine
1062667|NCT00662532|B3|Baseline|Total|Total of all reporting groups
1062668|NCT00662532|B2|Baseline|No Intervention|Control group receiving no drug intervention
1062669|NCT00662532|B1|Baseline|Minocycline HCl|1 mg microspheres of minocycline hydrochloride
1062670|NCT00662532|P2|Participant Flow|No Intervention|Control group receiving no drug intervention
1062671|NCT00662532|P1|Participant Flow|Minocycline HCl|1 mg microspheres of minocycline hydrochloride
1062672|NCT00662532|O2|Outcome|No Intervention|Control group receiving no drug intervention
1062673|NCT00662532|O1|Outcome|Minocycline HCl|1 mg microspheres of minocycline hydrochloride
1062674|NCT00662532|O2|Outcome|No Intervention|Control group receiving no drug intervention
1062675|NCT00662532|O1|Outcome|Minocycline HCl|1 mg microspheres of minocycline hydrochloride
1062676|NCT00662532|O2|Outcome|No Intervention|Control group receiving no drug intervention
1062677|NCT00662532|O1|Outcome|Minocycline HCl|1 mg microspheres of minocycline hydrochloride
1062678|NCT00662532|E2|Reported Event|No Intervention|Control group receiving no drug intervention
1062679|NCT00662532|E1|Reported Event|Minocycline HCl|1 mg microspheres of minocycline hydrochloride
1062680|NCT00662389|B1|Baseline|A--Thermal Wand Application|
1062681|NCT00662389|P1|Participant Flow|A--Thermal Wand Application|
1062682|NCT00662389|O1|Outcome|A--Thermal Wand Application|
1062683|NCT00662363|B3|Baseline|Total|Total of all reporting groups
1062684|NCT00662363|B2|Baseline|Senna|Senna 2 tabs daily for 6 days with placebo lubiprostone tabs
1062685|NCT00662363|B1|Baseline|Lubiprostone|Lubiprostone24 µg po BID for 6 days with placebo senna tab
1062686|NCT00662363|P2|Participant Flow|Senna|Senna 2 tabs daily for 6 days with placebo lubiprostone tabs
1062687|NCT00662363|P1|Participant Flow|Lubiprostone|Lubiprostone24 µg po BID for 6 days with placebo senna tab
1062688|NCT00662363|O2|Outcome|Senna|Change in PAC-QOL
1062689|NCT00662363|O1|Outcome|Lubiprostone|change in PAC-QOL
1062690|NCT00662363|O2|Outcome|Senna|Senna 2 tabs daily for 6 days with placebo lubiprostone tabs
1062691|NCT00662363|O1|Outcome|Lubiprostone|Lubiprostone24 µg po BID for 6 days with placebo senna tab
1062692|NCT00662363|E2|Reported Event|Senna|Senna 2 tabs daily for 6 days with placebo lubiprostone tabs
1062693|NCT00662363|E1|Reported Event|Lubiprostone|Lubiprostone24 µg po BID for 6 days with placebo senna tab
1062694|NCT00662311|B4|Baseline|Total|Total of all reporting groups
1062695|NCT00662311|B3|Baseline|Vorinostat 400 mg|"Cohort 3: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
1062696|NCT00662311|B2|Baseline|Vorinostat 300 mg|"Cohort 2: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
1062697|NCT00662311|B1|Baseline|Vorinostat 200 mg|"Cohort 1: Patients receive 200 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
1062698|NCT00662311|P3|Participant Flow|Vorinostat 400 mg|"Cohort 3: Patients receive 400 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
1062699|NCT00662311|P2|Participant Flow|Vorinostat 300 mg|"Cohort 2: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
1062786|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1063427|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1062700|NCT00662311|P1|Participant Flow|Vorinostat 200 mg|"Cohort 1: Patients receive 200 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
1062701|NCT00662311|O3|Outcome|Vorinostat 400 mg|"Cohort 3: Patients receive 400 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
1062702|NCT00662311|O2|Outcome|Vorinostat 300 mg|"Cohort 2: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
1062703|NCT00662311|O1|Outcome|Vorinostat 200 mg|"Cohort 1: Patients receive 200 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
1062704|NCT00662311|O3|Outcome|Vorinostat 400 mg|"Cohort 3: Patients receive 400 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
1062705|NCT00662311|O2|Outcome|Vorinostat 300 mg|"Cohort 2: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
1062706|NCT00662311|O1|Outcome|Vorinostat 200 mg|"Cohort 1: Patients receive 200 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
1062707|NCT00662311|O3|Outcome|Vorinostat 400 mg|"Cohort 3: Patients receive 400 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
1062708|NCT00662311|O2|Outcome|Vorinostat 300 mg|"Cohort 2: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
1062709|NCT00662311|O1|Outcome|Vorinostat 200 mg|"Cohort 1: Patients receive 200 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
1062710|NCT00662311|O3|Outcome|Vorinostat 400 mg|"Cohort 3: Patients receive 400 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
1062711|NCT00662311|O2|Outcome|Vorinostat 300 mg|"Cohort 2: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
1062712|NCT00662311|O1|Outcome|Vorinostat 200 mg|"Cohort 1: Patients receive 200 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
1062713|NCT00662311|O3|Outcome|Vorinostat 400 mg|"Cohort 3: Patients receive 400 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
1062714|NCT00662311|O2|Outcome|Vorinostat 300 mg|"Cohort 2: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
1062715|NCT00662311|O1|Outcome|Vorinostat 200 mg|"Cohort 1: Patients receive 200 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
1062716|NCT00662311|O3|Outcome|Vorinostat 400 mg|"Cohort 3: Patients receive 400 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
1062717|NCT00662311|O2|Outcome|Vorinostat 300 mg|"Cohort 2: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
1062932|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
1062718|NCT00662311|O1|Outcome|Vorinostat 200 mg|"Cohort 1: Patients receive 200 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
1062719|NCT00662311|E3|Reported Event|Vorinostat 400 mg|"Cohort 3: Patients receive 400 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
1062720|NCT00662311|E2|Reported Event|Vorinostat 300 mg|"Cohort 2: Patients receive 300 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
1062721|NCT00662311|E1|Reported Event|Vorinostat 200 mg|"Cohort 1: Patients receive 200 mg vorinostat PO QD, 5 days a week and paclitaxel IV over 1 hour once a week. Patients also undergo radiation therapy QD, 5 days a week. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~paclitaxel: Given IV~radiation therapy: Undergo radiation therapy"
1062722|NCT00662207|B1|Baseline|All Participants|
1062723|NCT00662207|P1|Participant Flow|Experimental Group|"Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; or use a dilator of the anus to determine if urethral relaxation will occur~Vibrator: A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction~Anal dilator: A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter~A single urodynamic testing protocol was conducted for each patient. Techniques included urodynamic catheters, perineum vibration, and anal dilation with a balloon dilator.~Responses of the bladder and the external urethral and anal sphincters were recorded"
1062724|NCT00662207|O1|Outcome|Experimental Group|"Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; or use a dilator of the anus to determine if urethral relaxation will occur~Vibrator: A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction~Anal dilator: A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter~A single urodynamic testing protocol was conducted for each patient. Techniques included urodynamic catheters, perineum vibration, and anal dilation with a balloon dilator.~Responses of the bladder and the external urethral and anal sphincters were recorded"
1062725|NCT00662207|O1|Outcome|Experimental Group|"Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; or use a dilator of the anus to determine if urethral relaxation will occur~Vibrator: A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction~Anal dilator: A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter~A single urodynamic testing protocol was conducted for each patient. Techniques included urodynamic catheters, perineum vibration, and anal dilation with a balloon dilator.~Responses of the bladder and the external urethral and anal sphincters were recorded"
1062726|NCT00662207|O1|Outcome|Experimental Group|"Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; or use a dilator of the anus to determine if urethral relaxation will occur~Vibrator: A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction~Anal dilator: A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter~A single urodynamic testing protocol was conducted for each patient. Techniques included urodynamic catheters, perineum vibration, and anal dilation with a balloon dilator.~Responses of the bladder and the external urethral and anal sphincters were recorded"
1062727|NCT00662207|O1|Outcome|Experimental Group|"Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; or use a dilator of the anus to determine if urethral relaxation will occur~Vibrator: A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction~Anal dilator: A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter~A single urodynamic testing protocol was conducted for each patient. Techniques included urodynamic catheters, perineum vibration, and anal dilation with a balloon dilator.~Responses of the bladder and the external urethral and anal sphincters were recorded"
1062728|NCT00662207|E1|Reported Event|Experimental Group|"Use a vibrator on the patient's bottom to determine if it will induce a bladder contraction; or use a dilator of the anus to determine if urethral relaxation will occur~Vibrator: A vibrator will be applied to the patient's bottom to determine if it will induce a bladder contraction~Anal dilator: A balloon will be used for anal dilation to determine if it will result in relaxation of the pelvic floor and urethral sphincter~A single urodynamic testing protocol was conducted for each patient. Techniques included urodynamic catheters, perineum vibration, and anal dilation with a balloon dilator.~Responses of the bladder and the external urethral and anal sphincters were recorded"
1062729|NCT00662129|B1|Baseline|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1062730|NCT00662129|P1|Participant Flow|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1062731|NCT00662129|O1|Outcome|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1062787|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1073271|NCT00631748|P2|Participant Flow|Placebo|Placebo (sugar pill)
1062732|NCT00662129|O1|Outcome|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1062733|NCT00662129|O1|Outcome|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1062734|NCT00662129|O1|Outcome|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1062735|NCT00662129|O1|Outcome|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1062736|NCT00662129|O1|Outcome|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1062737|NCT00662129|O1|Outcome|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1062738|NCT00662129|E1|Reported Event|Paclitaxel + Gemcitabine + Bevacizumab|Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1062739|NCT00662038|B1|Baseline|Pirfenidone|Pirfenidone, 2403 milligrams per day (mg/d), administered orally, as capsules in 801 mg doses, three times daily.
1062740|NCT00662038|P1|Participant Flow|Pirfenidone|Pirfenidone, 2403 milligrams per day (mg/d), administered orally, as capsules in 801 mg doses, three times daily.
1062741|NCT00662038|O1|Outcome|Pirfenidone|Pirfenidone, 2403 milligrams per day (mg/d), administered orally, as capsules in 801 mg doses, three times daily.
1062742|NCT00662038|E1|Reported Event|Pirfenidone|Pirfenidone, 2403 milligrams per day (mg/d), administered orally, as capsules in 801 mg doses, three times daily.
1062743|NCT00662025|B1|Baseline|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
1062744|NCT00662025|P1|Participant Flow|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
1062745|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
1062746|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
1062747|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
1062748|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
1062749|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
1073272|NCT00631748|P1|Participant Flow|Study Drug|Oral quetiapine
1062750|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
1062751|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
1062752|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
1062753|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
1062754|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
1062755|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
1062756|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
1062757|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
1062758|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
1062759|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
1062760|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
1062761|NCT00662025|O1|Outcome|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
1062762|NCT00662025|E1|Reported Event|SUNITINIB+CAPECITABINE|Sunitinib was administered orally from Day 1 at the starting dose of 37.5 mg/day on a continuous daily dosing schedule in 21-day cycles. Capecitabine was administered orally from Days 1 to 14 every 21 days at a starting dose of 2,000 mg/m^2/day. Participants were monitored for toxicity, and sunitinib and/or capecitabine dosing could be interrupted or reduced according to individual tolerance. Participants with progressive disease (PD) or intolerable toxicity were considered for discontinuation from the study.
1062788|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062763|NCT00662012|B1|Baseline|SSG 20 mg/kg|"All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with SSG.~Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days."
1062764|NCT00662012|P1|Participant Flow|SSG 20 mg/kg|"All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with SSG.~Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days."
1062765|NCT00662012|O1|Outcome|SSG 20 mg/kg|"All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with SSG.~Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days."
1062766|NCT00662012|O1|Outcome|SSG 20 mg/kg|"All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with SSG.~Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days."
1062767|NCT00662012|E1|Reported Event|SSG 20 mg/kg|"All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with SSG.~Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days for less responsive; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days."
1062768|NCT00661999|B4|Baseline|Total|Total of all reporting groups
1062769|NCT00661999|B3|Baseline|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062770|NCT00661999|B2|Baseline|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062771|NCT00661999|B1|Baseline|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062772|NCT00661999|P3|Participant Flow|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062773|NCT00661999|P2|Participant Flow|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062774|NCT00661999|P1|Participant Flow|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062775|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062776|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062777|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062778|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062779|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062780|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062781|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062782|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062783|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062784|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062785|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1073273|NCT00631748|O2|Outcome|Placebo|match placebo (sugar pill)
1062789|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062790|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062791|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062792|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062793|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062794|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062795|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062796|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062797|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062798|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062799|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062800|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062801|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062802|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062803|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062804|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062805|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062806|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062807|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062808|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062809|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062810|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062811|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062812|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062813|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062814|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062815|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062816|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062817|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1063704|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
1062818|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062819|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062820|NCT00661999|O3|Outcome|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062821|NCT00661999|O2|Outcome|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062822|NCT00661999|O1|Outcome|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062823|NCT00661999|E3|Reported Event|DA + Placebo|Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062824|NCT00661999|E2|Reported Event|DA + Oral Iron|Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062825|NCT00661999|E1|Reported Event|DA + IV Iron|Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
1062826|NCT00661960|B4|Baseline|Total|Total of all reporting groups
1062827|NCT00661960|B3|Baseline|HIV-postive Randomized to NNRTI|HIV-Positive volunteers taking efavirenz or any other non-nucleoside reverse transcriptase inhibitors (NNRTI) in combination with two other nucleoside reverse transcriptase inhibitor (NRTI) medications
1062828|NCT00661960|B2|Baseline|HIV-postive Randomized to Raltegravir|HIV-Positive volunteers taking raltegravir in combination with two other nucleoside reverse transcriptase inhibitors (NRTI) medications
1062829|NCT00661960|B1|Baseline|Negative Volunteers|HIV Negative volunteers
1062830|NCT00661960|P3|Participant Flow|HIV-postive Randomized to NNRTI|HIV-Positive volunteers taking efavirenz or any other non-nucleoside reverse transcriptase inhibitors (NNRTI) in combination with two other nucleoside reverse transcriptase inhibitor (NRTI) medications
1062831|NCT00661960|P2|Participant Flow|HIV-postive Randomized to Raltegravir|HIV-Positive volunteers taking raltegravir in combination with two other nucleoside reverse transcriptase inhibitors (NRTI) medications
1062832|NCT00661960|P1|Participant Flow|Negative Volunteers|HIV Negative volunteers
1062833|NCT00661960|O3|Outcome|HIV-postive Randomized to NNRTI|HIV-Positive volunteers taking efavirenz or any other non-nucleoside reverse transcriptase inhibitors (NNRTI) in combination with two other nucleoside reverse transcriptase inhibitor (NRTI) medications
1062834|NCT00661960|O2|Outcome|HIV-postive Randomized to Raltegravir|HIV-Positive volunteers taking raltegravir in combination with two other nucleoside reverse transcriptase inhibitors (NRTI) medications
1062835|NCT00661960|O1|Outcome|Negative Volunteers|HIV Negative volunteers
1062836|NCT00661960|E3|Reported Event|HIV-postive Randomized to NNRTI|HIV-Positive volunteers taking efavirenz or any other non-nucleoside reverse transcriptase inhibitors (NNRTI) in combination with two other nucleoside reverse transcriptase inhibitor (NRTI) medications
1062837|NCT00661960|E2|Reported Event|HIV-postive Randomized to Raltegravir|HIV-Positive volunteers taking raltegravir in combination with two other nucleoside reverse transcriptase inhibitors (NRTI) medications
1062838|NCT00661960|E1|Reported Event|Negative Volunteers|HIV Negative volunteers
1062839|NCT00661895|B3|Baseline|Total|Total of all reporting groups
1062840|NCT00661895|B2|Baseline|Control|No intervention
1062841|NCT00661895|B1|Baseline|Intervention|Intervention group subjects will receive education and assistance from a Community Health Center or Cardiac Center nurse practitioner or physician, health educator, dietitian, social worker, and Cardiac Center-trained community members called Community Health Advocates (CHAs).
1062842|NCT00661895|P2|Participant Flow|Control|No intervention
1062843|NCT00661895|P1|Participant Flow|Intervention|Intervention group subjects will receive education and assistance from a Community Health Center or Cardiac Center nurse practitioner or physician, health educator, dietitian, social worker, and Cardiac Center-trained community members called Community Health Advocates (CHAs).
1062844|NCT00661895|O2|Outcome|Control|Free antihypertensive medications, basic hypertension education and usual clinical care.
1062845|NCT00661895|O1|Outcome|Intervention|Free antihypertensive medications, in-depth HTN and healthy living education, behavior change counseling, and Therapeutic Lifestyle Change following JNC-VII guidelines.
1062846|NCT00661895|E2|Reported Event|Control|No intervention
1062847|NCT00661895|E1|Reported Event|Intervention|Intervention group subjects will receive education and assistance from a Community Health Center or Cardiac Center nurse practitioner or physician, health educator, dietitian, social worker, and Cardiac Center-trained community members called Community Health Advocates (CHAs).
1062848|NCT00661830|B3|Baseline|Total|Total of all reporting groups
1062849|NCT00661830|B2|Baseline|Gemcitabine + Placebo|"Gemcitabine + Placebo~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.~Placebo : Placebo"
1062850|NCT00661830|B1|Baseline|Gemcitabine + Sorafenib|"Gemcitabine + Sorafenib~Sorafenib : Sorafenib 400 mg bid orally continuously~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15."
1062851|NCT00661830|P2|Participant Flow|Gemcitabine + Placebo|"Gemcitabine + Placebo~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.~Placebo : Placebo"
1062852|NCT00661830|P1|Participant Flow|Gemcitabine + Sorafenib|"Gemcitabine + Sorafenib~Sorafenib : Sorafenib 400 mg bid orally continuously~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15."
1062881|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
1062853|NCT00661830|O2|Outcome|Gemcitabine + Placebo|"Gemcitabine + Placebo~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.~Placebo : Placebo"
1062854|NCT00661830|O1|Outcome|Gemcitabine + Sorafenib|"Gemcitabine + Sorafenib~Sorafenib : Sorafenib 400 mg bid orally continuously~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15."
1062855|NCT00661830|O2|Outcome|Gemcitabine + Placebo|"Gemcitabine + Placebo~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.~Placebo : Placebo"
1062856|NCT00661830|O1|Outcome|Gemcitabine + Sorafenib|"Gemcitabine + Sorafenib~Sorafenib : Sorafenib 400 mg bid orally continuously~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15."
1062857|NCT00661830|O2|Outcome|Gemcitabine + Placebo|"Gemcitabine + Placebo~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.~Placebo : Placebo"
1062858|NCT00661830|O1|Outcome|Gemcitabine + Sorafenib|"Gemcitabine + Sorafenib~Sorafenib : Sorafenib 400 mg bid orally continuously~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15."
1062859|NCT00661830|O2|Outcome|Gemcitabine + Placebo|"Gemcitabine + Placebo~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.~Placebo : Placebo"
1062860|NCT00661830|O1|Outcome|Gemcitabine + Sorafenib|"Gemcitabine + Sorafenib~Sorafenib : Sorafenib 400 mg bid orally continuously~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15."
1062861|NCT00661830|E2|Reported Event|Gemcitabine + Placebo|"Gemcitabine + Placebo~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15.~Placebo : Placebo"
1062862|NCT00661830|E1|Reported Event|Gemcitabine + Sorafenib|"Gemcitabine + Sorafenib~Sorafenib : Sorafenib 400 mg bid orally continuously~Gemcitabine : Gemcitabine 1000 mg/m2 body surface i.v. first cycle at day 1, 8, 15, 22, 29, 36, 43. Next cycles at day 1, 8, 15."
1062863|NCT00661778|B1|Baseline|Bevacizumab + Cisplatin + Docetaxel|Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
1062864|NCT00661778|P1|Participant Flow|Bevacizumab + Cisplatin + Docetaxel|Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
1062865|NCT00661778|O1|Outcome|Bevacizumab + Cisplatin + Docetaxel|Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
1062866|NCT00661778|O1|Outcome|Bevacizumab + Cisplatin + Docetaxel|Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
1062867|NCT00661778|O1|Outcome|Bevacizumab + Cisplatin + Docetaxel|Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
1062868|NCT00661778|O1|Outcome|Bevacizumab + Cisplatin + Docetaxel|Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
1062869|NCT00661778|E1|Reported Event|Bevacizumab + Cisplatin + Docetaxel|Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
1062870|NCT00661726|B1|Baseline|Phase IIA Open Label, Single-arm, Multi-center Pilot Study|Participants will receive injected decitabine for 12 weeks.
1062871|NCT00661726|P1|Participant Flow|Phase IIA Open Label, Single-arm, Multi-center Pilot Study|Participants will receive injected decitabine for 12 weeks.
1062872|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
1062873|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
1062874|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
1062875|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
1062876|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
1062877|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
1062878|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
1062879|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
1062880|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
1062882|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
1062883|NCT00661726|O1|Outcome|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
1062884|NCT00661726|E1|Reported Event|Decitabine|Decitabine 0.2 mg/kg was administered subcutaneously daily on the same 2 consecutive days each week for 12 weeks.
1062885|NCT00661713|B9|Baseline|Total|Total of all reporting groups
1062886|NCT00661713|B8|Baseline|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
1062887|NCT00661713|B7|Baseline|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
1062888|NCT00661713|B6|Baseline|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
1062889|NCT00661713|B5|Baseline|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
1062890|NCT00661713|B4|Baseline|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
1062891|NCT00661713|B3|Baseline|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
1062892|NCT00661713|B2|Baseline|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
1062893|NCT00661713|B1|Baseline|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
1062894|NCT00661713|P8|Participant Flow|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
1062895|NCT00661713|P7|Participant Flow|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
1062896|NCT00661713|P6|Participant Flow|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
1062897|NCT00661713|P5|Participant Flow|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
1062898|NCT00661713|P4|Participant Flow|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
1062899|NCT00661713|P3|Participant Flow|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
1062900|NCT00661713|P2|Participant Flow|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
1062901|NCT00661713|P1|Participant Flow|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
1062902|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
1062903|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
1062904|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
1062905|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
1062906|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
1062907|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
1062908|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
1062909|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
1062910|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
1062911|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
1062912|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
1062913|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
1062914|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
1062915|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
1062916|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
1062917|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
1062918|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
1062919|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
1062920|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
1062921|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
1062922|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
1062923|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
1062924|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
1062925|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
1062926|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
1062927|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
1062928|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
1062929|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
1062930|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
1063705|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
1062933|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
1062934|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
1062935|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
1062936|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
1062937|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
1062938|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
1062939|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
1062940|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
1062941|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
1062942|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
1062943|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
1062944|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
1062945|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
1062946|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
1062947|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
1062948|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
1062949|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
1062950|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
1062951|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
1062952|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
1062953|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
1062954|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
1062955|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
1062956|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
1062957|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
1062958|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
1062959|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
1062960|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
1062961|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
1062962|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
1062963|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
1062964|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
1062965|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
1062966|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
1062967|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
1062968|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
1062969|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
1062970|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
1062971|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
1062972|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
1062973|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
1062974|NCT00661713|O8|Outcome|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
1062975|NCT00661713|O7|Outcome|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
1062976|NCT00661713|O6|Outcome|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
1062977|NCT00661713|O5|Outcome|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
1062978|NCT00661713|O4|Outcome|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
1062979|NCT00661713|O3|Outcome|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
1062980|NCT00661713|O2|Outcome|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
1062981|NCT00661713|O1|Outcome|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
1062982|NCT00661713|E8|Reported Event|rMenB6|Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
1062983|NCT00661713|E7|Reported Event|rMenB012|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
1062984|NCT00661713|E6|Reported Event|rMenB02|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
1062985|NCT00661713|E5|Reported Event|rMenB026|Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
1062986|NCT00661713|E4|Reported Event|rMenB01|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
1062987|NCT00661713|E3|Reported Event|rMenB016|Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
1062988|NCT00661713|E2|Reported Event|rMenB0|Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
1062989|NCT00661713|E1|Reported Event|rMenB06|Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
1062990|NCT00661687|B1|Baseline|PureVision Contact Lens|PureVision Contact Lens Original Design and New Design.
1062991|NCT00661687|P1|Participant Flow|PureVision Contact Lens|PureVision Contact Lens, Original Design and Alternate Design. Subjects randomly assigned to receive the Purevision test lens in one eye and the marketed Purevision lens in the fellow eye.
1062992|NCT00661687|O2|Outcome|PureVision Contact Lens Design #2|Redesign of the currently marketed PureVision soft contact lens.
1062993|NCT00661687|O1|Outcome|PureVision Contact Lens Design #1|PureVision soft contact lens (currently marketed).
1062994|NCT00661687|O2|Outcome|PureVision Contact Lens Design #2|Redesign of the currently marketed PureVision soft contact lens.
1062995|NCT00661687|O1|Outcome|PureVision Contact Lens Design #1|PureVision soft contact lens (currently marketed).
1062996|NCT00661687|O2|Outcome|PureVision Contact Lens Design #2|Redesign of the currently marketed PureVision soft contact lens.
1062997|NCT00661687|O1|Outcome|PureVision Contact Lens Design #1|PureVision soft contact lens (currently marketed).
1062998|NCT00661687|E2|Reported Event|PureVision Contact Lens Design #2|PureVision Contact Lens Test Design. Subjects randomly assigned to receive the Purevision test lens in one eye and the marketed Purevision lens in the fellow eye
1062999|NCT00661687|E1|Reported Event|PureVision Contact Lens Design #1|PureVision Contact Lens, Original Design. Subjects randomly assigned to receive the Purevision test lens in one eye and the marketed Purevision lens in the fellow eye.
1063000|NCT00661674|B1|Baseline|Overall Study|Over three study sessions each spaced one week apart participants received either placebo IV + PO, Palonosetron IV (0.75 mg) + placebo PO, or Palonosetron IV (0.75 mg) + Hydroxyzine PO (100mg).
1063001|NCT00661674|P6|Participant Flow|Sequence 6: Palonosetron, Placebo, Combo|"At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.~Week 1: Palonosetron~Week 2: Placebo~Week 3: Combo"
1063002|NCT00661674|P5|Participant Flow|Sequence 5: Combo, Palonosetron, Placebo|"At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.~Week 1: Combo~Week 2: Palonosetron~Week 3: Placebo"
1063003|NCT00661674|P4|Participant Flow|Sequence 4: Placebo, Palonosetron, Combo|"At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.~Week 1: Placebo~Week 2: Palonosetron~Week 3: Combo"
1063004|NCT00661674|P3|Participant Flow|Sequence 3: Combo, Placebo, Palonosetron|"At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.~Week 1: Combo~Week 2: Placebo~Week 3: Palonosetron"
1063005|NCT00661674|P2|Participant Flow|Sequence 2: Palonosetron, Combo, Placebo|"At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.~Week 1: Palonosetron~Week 2: Combo~Week 3: Placebo"
1063024|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
1063205|NCT00661479|B4|Baseline|100 µg Brimonidine Tartrate Implant Group A|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
1063006|NCT00661674|P1|Participant Flow|Sequence 1: Placebo, Combo, Palonosetron|"At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.~Week 1: Placebo~Week 2: Combo~Week 3: Palonosetron"
1063007|NCT00661674|O3|Outcome|Palonosetron + Hydroxyzine|Each participant had one session in which they received IV palonosetron + PO hydroxyzine pretreatment prior to naloxone-precipitated withdrawal.
1063008|NCT00661674|O2|Outcome|Palonosetron|Each participant had one session in which they received palonosetron IV pretreatment prior to naloxone-precipitated withdrawal.
1063009|NCT00661674|O1|Outcome|Placebo|Each participant had one session in which they received a placebo tablet pretreatment prior to naloxone-precipitated withdrawal.
1063010|NCT00661674|O3|Outcome|Palonosetron + Hydroxyzine|Each participant had one session in which they received IV palonosetron + PO hydroxyzine pretreatment prior to naloxone-precipitated withdrawal.
1063011|NCT00661674|O2|Outcome|Palonosetron|Each participant had one session in which they received palonosetron IV pretreatment prior to naloxone-precipitated withdrawal.
1063012|NCT00661674|O1|Outcome|Placebo|Each participant had one session in which they received a placebo tablet pretreatment prior to naloxone-precipitated withdrawal.
1063013|NCT00661674|E3|Reported Event|Palonosetron + Hydroxyzine|At timepoint T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. Participants returned for three study sessions, each one week apart to receive all three study combinations. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.
1063014|NCT00661674|E2|Reported Event|Palonosetron + Placebo|At timepoint T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with palonosetron IV (0.75mg) in a crossover study design. Participants returned for three study sessions, each one week apart to receive all three study drug combinations. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.
1063015|NCT00661674|E1|Reported Event|Placebo|At timepoint T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with placebo (0.9% normal saline) in a crossover study design. Participants returned for three study sessions, each one week apart to receive all three study combinations. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15.
1063016|NCT00661661|B3|Baseline|Total|Total of all reporting groups
1063017|NCT00661661|B2|Baseline|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
1063018|NCT00661661|B1|Baseline|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
1063019|NCT00661661|P2|Participant Flow|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
1063020|NCT00661661|P1|Participant Flow|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
1063021|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
1063022|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
1063023|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
1073274|NCT00631748|O1|Outcome|Study Drug|Quetiapine (Seroquel XR)
1063025|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
1063026|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
1063027|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
1063028|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
1063029|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
1063030|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
1063031|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
1063032|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
1063033|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
1063034|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
1063035|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
1063036|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
1063037|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
1063038|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
1063039|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
1063040|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
1063141|NCT00661570|O1|Outcome|Provox Vega 20|26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
1063041|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
1063042|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
1063043|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
1063044|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
1063045|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
1063046|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
1063047|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
1063048|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
1063049|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
1063050|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
1063051|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
1063052|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
1063053|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
1063054|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
1063055|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
1063056|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
1063142|NCT00661570|O1|Outcome|Provox Vega 20|26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
1063057|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
1063058|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
1063059|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
1063060|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
1063061|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
1063062|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
1063063|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
1063064|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
1063065|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
1063066|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
1063067|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
1063068|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
1063069|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
1063070|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
1063071|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
1063072|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
1063143|NCT00661570|O1|Outcome|Provox Vega 20|26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
1063073|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
1063074|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
1063075|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
1063076|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
1063077|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
1063078|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
1063079|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
1063080|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
1063081|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
1063082|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
1063083|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
1063084|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
1063085|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
1063086|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
1063087|NCT00661661|O3|Outcome|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
1063088|NCT00661661|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
1063144|NCT00661570|O1|Outcome|Provox Vega 20|26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
1063089|NCT00661661|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
1063090|NCT00661661|E3|Reported Event|Total|All subjects were assigned oral CP-690,550 5 mg tablets twice a day at baseline visit. Dose flexibility (increasing from 5 mg BID to 10 mg BID, reducing from 10 mg BID to 5 mg BID, or temporary discontinuation) during study was allowed in consideration for the risks and benefits to the patient’s condition. Data was summarized in three reporting groups including CP-690,550 5 mg BID, CP-690,550 10 mg BID and Total.
1063091|NCT00661661|E2|Reported Event|CP-690,550 10 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for more than or equal to 84 days in total within the long-term safety study (A3921041) were grouped into CP-690,550 10 mg BID.
1063092|NCT00661661|E1|Reported Event|CP-690,550 5 mg BID|CP-690,550 5 milligram (mg) tablet orally twice daily (BID). After Week 12, the dose could be changed 5 mg BID or 10 mg BID based on investigator discretion. This study was continued until CP-690,550 was commercially supplied to participants at the sites. Participants who were exposed to 10 mg BID for less than 84 days in total within the current study (A3921041) were grouped into CP-690,550 5 mg BID.
1063093|NCT00661622|B3|Baseline|Total|Total of all reporting groups
1063094|NCT00661622|B2|Baseline|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
1063095|NCT00661622|B1|Baseline|Immunoembolization|"Liver embolization treatment with injection of GM-CSF.~GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
1063096|NCT00661622|P2|Participant Flow|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
1063097|NCT00661622|P1|Participant Flow|Immunoembolization|"Liver embolization treatment with injection of GM-CSF.~GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
1063098|NCT00661622|O2|Outcome|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
1063099|NCT00661622|O1|Outcome|Immunoembolization|"Liver embolization treatment with injection of GM-CSF.~GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
1063100|NCT00661622|O2|Outcome|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
1063101|NCT00661622|O1|Outcome|Immunoembolization|"Liver embolization treatment with injection of GM-CSF.~GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
1063102|NCT00661622|O2|Outcome|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
1063103|NCT00661622|O1|Outcome|Immunoembolization|"Liver embolization treatment with injection of GM-CSF.~GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
1063104|NCT00661622|O2|Outcome|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
1063105|NCT00661622|O1|Outcome|Immunoembolization|"Liver embolization treatment with injection of GM-CSF.~GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
1063188|NCT00661492|O2|Outcome|Arm 2|Novantrone
1063189|NCT00661492|O1|Outcome|Arm 1|Novantrone+Erbitux
1063106|NCT00661622|O2|Outcome|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
1063107|NCT00661622|O1|Outcome|Immunoembolization|"Liver embolization treatment with injection of GM-CSF.~GM-CSF: 2,000 mcg injected into the liver every 4 weeks alternating between right or left lobe when tumors present throughout liver.~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of GM-CSF in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
1063108|NCT00661622|E2|Reported Event|Plain Embolization|"Liver embolization with normal saline injected in place of GM-CSF~Embolization: A catheter will be introduced to one of the hepatic arteries by way of the femoral artery (groin) to allow injection of normal saline in combination with ethiodized oil and gelatin sponge providing a temporary blockage of the blood supply from the hepatic (liver) artery"
1063109|NCT00661622|E1|Reported Event|Immunoembolization|Liver embolization treatment with injection of GM-CSF.
1063110|NCT00661609|B1|Baseline|AZD4877|AZD4877 25 mg (Intravenous (IV), 25mg weekly)
1063111|NCT00661609|P1|Participant Flow|AZD4877|AZD4877 25 mg (Intravenous (IV), 25mg weekly)
1063112|NCT00661609|O1|Outcome|AZD4877|AZD4877 25 mg (Intravenous (IV), 25mg weekly)
1063113|NCT00661609|O1|Outcome|AZD4877|AZD4877 25 mg (Intravenous (IV), 25mg weekly)
1063114|NCT00661609|O1|Outcome|AZD4877|AZD4877 25 mg (Intravenous (IV), 25mg weekly)
1063115|NCT00661609|O1|Outcome|AZD4877|AZD4877 25 mg (Intravenous (IV), 25mg weekly)
1063116|NCT00661609|E1|Reported Event|AZD4877|AZD4877 25 mg (Intravenous (IV), 25mg weekly)
1063117|NCT00661583|B4|Baseline|Total|Total of all reporting groups
1063118|NCT00661583|B3|Baseline|MMC Alone|"MMC therapy alone (n=10)~MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy."
1063119|NCT00661583|B2|Baseline|Ranibizumab and MMC|"Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)~Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy"
1063120|NCT00661583|B1|Baseline|Ranibizumab Alone|"Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)~Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed"
1063121|NCT00661583|P3|Participant Flow|MMC Alone|"MMC therapy alone (n=10)~MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy."
1063122|NCT00661583|P2|Participant Flow|Ranibizumab and MMC|"Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)~Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy"
1063123|NCT00661583|P1|Participant Flow|Ranibizumab Alone|"Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)~Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed"
1063124|NCT00661583|O3|Outcome|MMC Alone|"MMC therapy alone (n=10)~MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy."
1063125|NCT00661583|O2|Outcome|Ranibizumab and MMC|"Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)~Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy"
1063126|NCT00661583|O1|Outcome|Ranibizumab Alone|"Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)~Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed"
1063127|NCT00661583|O3|Outcome|MMC Alone|"MMC therapy alone (n=10)~MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy."
1063128|NCT00661583|O2|Outcome|Ranibizumab and MMC|"Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)~Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy"
1063129|NCT00661583|O1|Outcome|Ranibizumab Alone|"Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)~Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed"
1063130|NCT00661583|O3|Outcome|MMC Alone|"MMC therapy alone (n=10)~MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy."
1063131|NCT00661583|O2|Outcome|Ranibizumab and MMC|"Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)~Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy"
1063132|NCT00661583|O1|Outcome|Ranibizumab Alone|"Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)~Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed"
1063133|NCT00661583|O3|Outcome|MMC Alone|"MMC therapy alone (n=10)~MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy."
1063134|NCT00661583|O2|Outcome|Ranibizumab and MMC|"Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)~Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy"
1063135|NCT00661583|O1|Outcome|Ranibizumab Alone|"Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)~Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed"
1063136|NCT00661583|E3|Reported Event|MMC Alone|"MMC therapy alone (n=10)~MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy."
1063137|NCT00661583|E2|Reported Event|Ranibizumab and MMC|"Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)~Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy"
1063138|NCT00661583|E1|Reported Event|Ranibizumab Alone|"Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)~Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed"
1063139|NCT00661570|B1|Baseline|Provox Vega 20|26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
1063140|NCT00661570|P1|Participant Flow|Provox Vega 20|26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
1063145|NCT00661570|E1|Reported Event|Provox Vega 20|26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.
1063146|NCT00661544|B1|Baseline|Arsenic Trioxide + Vitamin C + Melphalan|Arsenic Trioxide + Ascorbic Acid + Melphalan as a preparative regimen for autologous stem cell transplantation (delivered on Day 0)
1063147|NCT00661544|P1|Participant Flow|Arsenic Trioxide + Vitamin C + Melphalan|Arsenic Trioxide + Ascorbic Acid + Melphalan as a preparative regimen for autologous stem cell transplantation (delivered on Day 0)
1063148|NCT00661544|O1|Outcome|Arsenic Trioxide + Vitamin C + Melphalan|Arsenic Trioxide + Ascorbic Acid + Melphalan as a preparative regimen for autologous stem cell transplantation (delivered on Day 0)
1063149|NCT00661544|E1|Reported Event|Arsenic Trioxide + Vitamin C + Melphalan|Arsenic Trioxide + Ascorbic Acid + Melphalan as a preparative regimen for autologous stem cell transplantation (delivered on Day 0)
1063150|NCT00661531|B1|Baseline|Estrace & Anastrozole|Estrace 10 mg three times a day for 3 months. After 3 months of estrace, the estrace will be stopped and anastrazole 1 mg daily will be administered
1063151|NCT00661531|P1|Participant Flow|Estrace & Anastrozole|"Estrace 10 mg three times a day for 3 months. After 3 months of estrace, the estrace will be stopped and anastrazole 1 mg daily will be administered~Estrace: Estrace 10 mg three times daily will be administered for 3 months.~Anastrozole: After 3 months of estrace, patients who do not have evidence of disease progression will then be switched to received Anastrozole 1 mg daily as long as their disease benefits from this treatment"
1063152|NCT00661531|O1|Outcome|Estrace & Anastrozole|"Estrace 10 mg three times a day for 3 months. After 3 months of estrace, the estrace will be stopped and anastrazole 1 mg daily will be administered~Estrace: Estrace 10 mg three times daily will be administered for 3 months.~Anastrozole: After 3 months of estrace, patients who do not have evidence of disease progression will then be switched to received Anastrozole 1 mg daily as long as their disease benefits from this treatment"
1063153|NCT00661531|O1|Outcome|Estrace & Anastrozole|"Estrace 10 mg three times a day for 3 months. After 3 months of estrace, the estrace will be stopped and anastrazole 1 mg daily will be administered~Estrace: Estrace 10 mg three times daily will be administered for 3 months.~Anastrozole: After 3 months of estrace, patients who do not have evidence of disease progression will then be switched to received Anastrozole 1 mg daily as long as their disease benefits from this treatment"
1063154|NCT00661531|E1|Reported Event|Estrace & Anastrozole|"Estrace 10 mg three times a day for 3 months. After 3 months of estrace, the estrace will be stopped and anastrazole 1 mg daily will be administered~Estrace: Estrace 10 mg three times daily will be administered for 3 months.~Anastrozole: After 3 months of estrace, patients who do not have evidence of disease progression will then be switched to received Anastrozole 1 mg daily as long as their disease benefits from this treatment"
1063155|NCT00661505|B1|Baseline|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
1063156|NCT00661505|P1|Participant Flow|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
1063157|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
1063158|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
1063159|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
1063160|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
1063190|NCT00661492|O2|Outcome|Arm 2|Novantrone
1063161|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
1063162|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
1063163|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
1063164|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
1063165|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
1063166|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
1063167|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
1063168|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
1063169|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
1063170|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
1063191|NCT00661492|O1|Outcome|Arm 1|Novantrone+Erbitux
1063192|NCT00661492|O2|Outcome|Arm 2|Novantrone
1063193|NCT00661492|O1|Outcome|Arm 1|Novantrone+Erbitux
1063194|NCT00661492|O2|Outcome|Arm 2|Novantrone
1063195|NCT00661492|O1|Outcome|Arm 1|Novantrone+Erbitux
1063196|NCT00661492|O2|Outcome|Arm 2|Novantrone
1063197|NCT00661492|O1|Outcome|Arm 1|Novantrone+Erbitux
1063171|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
1063172|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
1063173|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
1063174|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
1063175|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
1063176|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
1063177|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
1063178|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
1063179|NCT00661505|O1|Outcome|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28 . The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
1063180|NCT00661505|E1|Reported Event|C.E.R.A. 120, 200, or 360 mcg|Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
1063181|NCT00661492|B3|Baseline|Total|Total of all reporting groups
1063182|NCT00661492|B2|Baseline|Arm 2|Novantrone
1063183|NCT00661492|B1|Baseline|Arm 1|Novantrone+Erbitux
1063184|NCT00661492|P2|Participant Flow|Arm 2|Novantrone
1063185|NCT00661492|P1|Participant Flow|Arm 1|Novantrone+Erbitux
1063186|NCT00661492|O2|Outcome|Arm 2|Novantrone
1063187|NCT00661492|O1|Outcome|Arm 1|Novantrone+Erbitux
1063206|NCT00661479|B3|Baseline|100 µg Brimonidine Tartrate Implant Group B|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
1063207|NCT00661479|B2|Baseline|200 µg Brimonidine Tartrate Implant Group B|200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
1063208|NCT00661479|B1|Baseline|400 µg Brimonidine Tartrate Implant Group B|400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
1063209|NCT00661479|P4|Participant Flow|100 µg Brimonidine Tartrate Implant Group A|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
1063210|NCT00661479|P3|Participant Flow|100 µg Brimonidine Tartrate Implant Group B|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
1063211|NCT00661479|P2|Participant Flow|200 µg Brimonidine Tartrate Implant Group B|200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
1063212|NCT00661479|P1|Participant Flow|400 µg Brimonidine Tartrate Implant Group B|400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
1063213|NCT00661479|O4|Outcome|100 µg Brimonidine Tartrate Implant Group A|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
1063214|NCT00661479|O3|Outcome|100 µg Brimonidine Tartrate Implant Group B|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
1063215|NCT00661479|O2|Outcome|200 µg Brimonidine Tartrate Implant Group B|200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
1063216|NCT00661479|O1|Outcome|400 µg Brimonidine Tartrate Implant Group B|400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
1063217|NCT00661479|O4|Outcome|100 µg Brimonidine Tartrate Implant Group A|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
1063218|NCT00661479|O3|Outcome|100 µg Brimonidine Tartrate Implant Group B|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
1063219|NCT00661479|O2|Outcome|200 µg Brimonidine Tartrate Implant Group B|200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
1063220|NCT00661479|O1|Outcome|400 µg Brimonidine Tartrate Implant Group B|400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
1063221|NCT00661479|E3|Reported Event|100 µg Brimonidine Tartrate Implant Groups A and B|100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
1063222|NCT00661479|E2|Reported Event|200 µg Brimonidine Tartrate Implant Group B|200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
1063223|NCT00661479|E1|Reported Event|400 µg Brimonidine Tartrate Implant Group B|400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
1063224|NCT00661453|B1|Baseline|SMA Type 1|"All patients will receive VPA and carnitine.~Valproic Acid and Levocarnitine: Drug: Valproic Acid and Levocarnitine; syrup; dosage is by weight"
1063225|NCT00661453|P1|Participant Flow|SMA Type 1|"All patients will receive VPA and carnitine.~Valproic Acid and Levocarnitine: Drug: Valproic Acid and Levocarnitine; syrup; dosage is by weight"
1063226|NCT00661453|O1|Outcome|SMA Type 1|"All patients will receive VPA and carnitine.~Valproic Acid and Levocarnitine: Drug: Valproic Acid and Levocarnitine; syrup; dosage is by weight"
1063227|NCT00661453|E1|Reported Event|SMA Type 1|"All patients will receive VPA and carnitine.~Valproic Acid and Levocarnitine: Drug: Valproic Acid and Levocarnitine; syrup; dosage is by weight"
1063228|NCT00661427|B3|Baseline|Total|Total of all reporting groups
1063229|NCT00661427|B2|Baseline|Arm B|Cetuximab infusion at 750 mg/m2 over 3 hours every other week.
1063230|NCT00661427|B1|Baseline|Arm A|Cetuximab infusion at 500 mg/m2 over 2 hours every other week.
1063231|NCT00661427|P2|Participant Flow|Arm B|Cetuximab infusion at 750 mg/m2 over 3 hours every other week.
1063232|NCT00661427|P1|Participant Flow|Arm A|Cetuximab infusion at 500 mg/m2 over 2 hours every other week.
1063233|NCT00661427|O2|Outcome|Arm B|Cetuximab infusion at 750 mg/m2 over 3 hours every other week.
1063234|NCT00661427|O1|Outcome|Arm A|Cetuximab infusion at 500 mg/m2 over 2 hours every other week.
1063235|NCT00661427|E2|Reported Event|Arm B|Cetuximab infusion at 750 mg/m2 over 3 hours every other week.
1063236|NCT00661427|E1|Reported Event|Arm A|Cetuximab infusion at 500 mg/m2 over 2 hours every other week.
1063237|NCT00661388|B1|Baseline|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
1063238|NCT00661388|P1|Participant Flow|C.E.R.A|Eligible participants were administered continuous erythropoietin receptor activator (C.E.R.A) subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 micrograms (mcg)/kilogram (kg). Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) within the target range of 10.0 and 12.0 grams (g)/ deciliter (dL).
1063239|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
1063240|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
1063241|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
1063242|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
1063243|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
1063244|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
1063245|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
1063246|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
1063247|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
1063248|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
1063249|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
1063250|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
1063251|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
1063252|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
1063253|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
1063254|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
1063255|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
1063256|NCT00661388|O1|Outcome|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
1063257|NCT00661388|E1|Reported Event|C.E.R.A|Eligible participants were administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. was 1.2 mcg/kg. Subsequent doses were adjusted to maintain the individual participant's Hb within the target range of 10.0 and 12.0 g/dL.
1063258|NCT00661362|B3|Baseline|Total|Total of all reporting groups
1063259|NCT00661362|B2|Baseline|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
1063260|NCT00661362|B1|Baseline|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
1063261|NCT00661362|P2|Participant Flow|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
1063262|NCT00661362|P1|Participant Flow|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
1063263|NCT00661362|O2|Outcome|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
1063264|NCT00661362|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
1063265|NCT00661362|O2|Outcome|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
1063266|NCT00661362|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
1063267|NCT00661362|O2|Outcome|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
1063268|NCT00661362|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
1063269|NCT00661362|O2|Outcome|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
1063270|NCT00661362|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
1063271|NCT00661362|O2|Outcome|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
1063272|NCT00661362|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
1063273|NCT00661362|O2|Outcome|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
1063274|NCT00661362|O1|Outcome|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
1063275|NCT00661362|E2|Reported Event|Placebo + Metformin|Placebo tablet, OD, added on to stable Metformin for 24 weeks
1063276|NCT00661362|E1|Reported Event|Saxagliptin 5 mg + Metformin|Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks
1063277|NCT00661258|B3|Baseline|Total|Total of all reporting groups
1063355|NCT00660829|O2|Outcome|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
1063356|NCT00660829|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
1063357|NCT00660829|O2|Outcome|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
1063278|NCT00661258|B2|Baseline|Control|"The control group patients were not given the data from the electronic data monitoring. Instead, they filled out a self report form that all patients fill out. If they indicated in this report that their adherence in the previous was less than 95%, then they were flagged for enhanced counseling with a doctor. This counseling was based on the patient's self report. Thus both groups received enhanced counseling if they indicated poor adherence, but only the intervention group were given their electronic data output."
1063279|NCT00661258|B1|Baseline|Intervention|The intervention group patients were given their electronic drug monitoring data at each monthly visit. The study coordinator would quickly calculate whether the patient's adherence was below 95% in the previous month. If so, that patient was flagged for enhanced counseling with a clinic doctor and this counseling was based on a printout containing the electronic drug monitoring data.
1063280|NCT00661258|P2|Participant Flow|Control|"The control group patients were not given the data from the electronic data monitoring. Instead, they filled out a self report form that all patients fill out. If they indicated in this report that their adherence in the previous was less than 95%, then they were flagged for enhanced counseling with a doctor. This counseling was based on the patient's self report. Thus both groups received enhanced counseling if they indicated poor adherence, but only the intervention group were given their electronic data output."
1063281|NCT00661258|P1|Participant Flow|Intervention|The intervention group patients were given their electronic drug monitoring data at each monthly visit. The study coordinator would quickly calculate whether the patient's adherence was below 95% in the previous month. If so, that patient was flagged for enhanced counseling with a clinic doctor and this counseling was based on a printout containing the electronic drug monitoring data.
1063282|NCT00661258|O2|Outcome|Control|The control group patients were not given the data from the electronic data monitoring. Instead, they filled out a self report form that all patients fill out. If they indicated in this report that their adherence in the previous was less than 95%, then they were flagged for
1063283|NCT00661258|O1|Outcome|Intervention|The intervention group patients were given their electronic drug monitoring data at each monthly visit. The study coordinator would quickly calculate whether the patient's adherence was below 95% in the previous month. If so, that patient was flagged for enhanced counseling with a clinic doctor and this counseling was based on a printout containing the electronic drug monitoring data.
1063284|NCT00661258|O2|Outcome|Control|The control group patients were not given the data from the electronic data monitoring. Instead, they filled out a self report form that all patients fill out. If they indicated in this report that their adherence in the previous was less than 95%, then they were flagged for
1063285|NCT00661258|O1|Outcome|Intervention|The intervention group patients were given their electronic drug monitoring data at each monthly visit. The study coordinator would quickly calculate whether the patient's adherence was below 95% in the previous month. If so, that patient was flagged for enhanced counseling with a clinic doctor and this counseling was based on a printout containing the electronic drug monitoring data.
1063286|NCT00661258|E2|Reported Event|Control|"The control group patients were not given the data from the electronic data monitoring. Instead, they filled out a self report form that all patients fill out. If they indicated in this report that their adherence in the previous was less than 95%, then they were flagged for enhanced counseling with a doctor. This counseling was based on the patient's self report. Thus both groups received enhanced counseling if they indicated poor adherence, but only the intervention group were given their electronic data output."
1063287|NCT00661258|E1|Reported Event|Intervention|The intervention group patients were given their electronic drug monitoring data at each monthly visit. The study coordinator would quickly calculate whether the patient's adherence was below 95% in the previous month. If so, that patient was flagged for enhanced counseling with a clinic doctor and this counseling was based on a printout containing the electronic drug monitoring data.
1063288|NCT00661193|B3|Baseline|Total|Total of all reporting groups
1063289|NCT00661193|B2|Baseline|Erlotinib Hydrochloride, Paclitaxel, Carboplatin|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1063290|NCT00661193|B1|Baseline|Erlotinib Hydrochloride|Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1063291|NCT00661193|P2|Participant Flow|Erlotinib Hydrochloride, Paclitaxel, Carboplatin|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1063292|NCT00661193|P1|Participant Flow|Erlotinib Hydrochloride|Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1063293|NCT00661193|O2|Outcome|Erlotinib Hydrochloride, Paclitaxel, Carboplatin|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1063294|NCT00661193|O1|Outcome|Erlotinib Hydrochloride|Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1063295|NCT00661193|O2|Outcome|Erlotinib Hydrochloride, Paclitaxel, Carboplatin|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1063296|NCT00661193|O1|Outcome|Erlotinib Hydrochloride|Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1063297|NCT00661193|E2|Reported Event|Erlotinib Hydrochloride, Paclitaxel, Carboplatin|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-16. Treatment repeats every 21 days for 4 courses. Beginning in course 5 and for all subsequent courses, patients receive oral erlotinib hydrochloride alone on days 1-21. Courses with erlotinib hydrochloride repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1063298|NCT00661193|E1|Reported Event|Erlotinib Hydrochloride|Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1063299|NCT00661089|B3|Baseline|Total|Total of all reporting groups
1063300|NCT00661089|B2|Baseline|Saline Injection|"Receives placebo injections following randomization (Saline).Delayed treatment group.~Blind broken and receives botulinum toxin at week 12"
1063301|NCT00661089|B1|Baseline|onabotulinumtoxinA Injection|Botulinum Toxin injected at second visit
1063302|NCT00661089|P2|Participant Flow|Saline Injection|"Receives placebo injections following randomization (Saline).Delayed treatment group.~Blind broken and receives botulinum toxin at week 12"
1063303|NCT00661089|P1|Participant Flow|onabotulinumtoxinA Injection|Botulinum Toxin injected at second visit
1063304|NCT00661089|O2|Outcome|Botulinum Toxin Injection|Group received botulinum toxin type A (Botox) in the pectoralis and teres major muscles
1063305|NCT00661089|O1|Outcome|Placebo|Group received saline injections intramuscularly of equivalent volume
1063306|NCT00661089|O2|Outcome|Botulinum Toxin Injection|Group received botulinum toxin type A (Botox) in the pectoralis and teres major muscles
1063307|NCT00661089|O1|Outcome|Placebo|Group recieved saline injections intramuscularly of equivalent volume
1063308|NCT00661089|E2|Reported Event|Saline Injection|"Receives placebo injections following randomization (Saline).Delayed treatment group.~Blind broken and receives botulinum toxin at week 12"
1063309|NCT00661089|E1|Reported Event|onabotulinumtoxinA Injection|Botulinum Toxin injected at second visit
1063310|NCT00660985|B3|Baseline|Total|Total of all reporting groups
1063311|NCT00660985|B2|Baseline|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
1063312|NCT00660985|B1|Baseline|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
1063313|NCT00660985|P2|Participant Flow|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
1063314|NCT00660985|P1|Participant Flow|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
1063315|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
1063316|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
1063317|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
1063318|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
1063319|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
1063320|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
1063321|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
1063322|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
1063323|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
1063324|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
1063325|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
1063326|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
1063327|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
1063328|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
1063329|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
1063330|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
1063331|NCT00660985|O2|Outcome|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
1063332|NCT00660985|O1|Outcome|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
1063333|NCT00660985|E2|Reported Event|Differin® Gel, 0.1%|Gel, 0.1%, 2g, once daily for 30 days
1063334|NCT00660985|E1|Reported Event|Differin® Gel, 0.3%|Gel, 0.3%, 2g, once daily for 30 days
1063335|NCT00660907|B3|Baseline|Total|Total of all reporting groups
1063336|NCT00660907|B2|Baseline|Glipizide Plus Metformin|Active Comparator glipizide plus metformin
1063337|NCT00660907|B1|Baseline|Dapagliflozin Plus Metformin|Experimental dapagliflozin plus metformin
1063338|NCT00660907|P2|Participant Flow|Glipizide Plus Metformin|Active Comparator glipizide plus metformin
1063339|NCT00660907|P1|Participant Flow|Dapagliflozin Plus Metformin|Experimental dapagliflozin plus metformin
1063340|NCT00660907|O2|Outcome|Glipizide Plus Metformin|Active Comparator glipizide plus metformin
1063341|NCT00660907|O1|Outcome|Dapagliflozin Plus Metformin|Experimental dapagliflozin plus metformin
1063342|NCT00660907|O2|Outcome|Glipizide Plus Metformin|Active Comparator glipizide plus metformin
1063343|NCT00660907|O1|Outcome|Dapagliflozin Plus Metformin|Experimental dapagliflozin plus metformin
1063344|NCT00660907|O2|Outcome|Glipizide Plus Metformin|Active Comparator glipizide plus metformin
1063345|NCT00660907|O1|Outcome|Dapagliflozin Plus Metformin|Experimental dapagliflozin plus metformin
1063346|NCT00660907|O2|Outcome|Glipizide Plus Metformin|Active Comparator glipizide plus metformin
1063347|NCT00660907|O1|Outcome|Dapagliflozin Plus Metformin|Experimental dapagliflozin plus metformin
1063348|NCT00660907|E2|Reported Event|Glipizide Plus Metformin|Active Comparator glipizide plus metformin
1063349|NCT00660907|E1|Reported Event|Dapagliflozin Plus Metformin|Experimental dapagliflozin plus metformin
1063350|NCT00660829|B3|Baseline|Total|Total of all reporting groups
1063351|NCT00660829|B2|Baseline|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
1063352|NCT00660829|B1|Baseline|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
1063353|NCT00660829|P2|Participant Flow|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
1063354|NCT00660829|P1|Participant Flow|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
1063359|NCT00660829|O2|Outcome|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
1063360|NCT00660829|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
1063361|NCT00660829|O2|Outcome|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
1063362|NCT00660829|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
1063363|NCT00660829|O2|Outcome|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
1063364|NCT00660829|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
1063365|NCT00660829|O2|Outcome|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
1063366|NCT00660829|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
1063367|NCT00660829|E2|Reported Event|Astepro 0.15%|0.15% Azelastine Hydrochloride Nasal Spray/2 sprays per nostril once daily for 14 days
1063368|NCT00660829|E1|Reported Event|Placebo|Placebo Nasal Spray/2 sprays per nostril once daily for 14 days
1063369|NCT00660816|B3|Baseline|Total|Total of all reporting groups
1063370|NCT00660816|B2|Baseline|Experimental|Alimta or Taxotere and Tarceva
1063371|NCT00660816|B1|Baseline|Active Comparator|Alimta or Taxotere alone
1063372|NCT00660816|P2|Participant Flow|Experimental|Alimta or Taxotere and Tarceva
1063373|NCT00660816|P1|Participant Flow|Active Comparator|Alimta or Taxotere alone
1063374|NCT00660816|O2|Outcome|Experimental|Alimta or Taxotere and Tarceva
1063375|NCT00660816|O1|Outcome|Active Comparator|Alimta or Taxotere alone
1063376|NCT00660816|O2|Outcome|Experimental|Alimta or Taxotere and Tarceva
1063377|NCT00660816|O1|Outcome|Active Comparator|Alimta or Taxotere alone
1063378|NCT00660816|O2|Outcome|Experimental|Alimta or Taxotere and Tarceva
1063379|NCT00660816|O1|Outcome|Active Comparator|Alimta or Taxotere alone
1063380|NCT00660816|O2|Outcome|Experimental|Alimta or Taxotere and Tarceva
1063381|NCT00660816|O1|Outcome|Active Comparator|Alimta or Taxotere alone
1063382|NCT00660816|E2|Reported Event|Experimental|Alimta or Taxotere and Tarceva
1063383|NCT00660816|E1|Reported Event|Active Comparator|Alimta or Taxotere alone
1063384|NCT00660699|B1|Baseline|Arm 1 (Gemcitabine, Docetaxel, 5FU, Radiation)|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
1063385|NCT00660699|P1|Participant Flow|Arm 1 (Gemcitabine, Docetaxel, 5FU, Radiation)|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
1063386|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
1063387|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
1063388|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
1063389|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
1063390|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
1063428|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063429|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063430|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063431|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063391|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
1063392|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
1063393|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
1063394|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
1063395|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
1063396|NCT00660699|O1|Outcome|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
1063397|NCT00660699|E1|Reported Event|Arm 1|"Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles~5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)~Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.~Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)~Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)"
1063398|NCT00660660|B3|Baseline|Total|Total of all reporting groups
1063399|NCT00660660|B2|Baseline|Placebo|Capsule once daily (QD)
1063400|NCT00660660|B1|Baseline|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063401|NCT00660660|P2|Participant Flow|Placebo|Capsule once daily (QD)
1063402|NCT00660660|P1|Participant Flow|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063403|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063404|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063405|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063406|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063407|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063408|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063409|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063410|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063411|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063412|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063413|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063414|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063415|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063416|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063417|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063418|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063419|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063420|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063421|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063422|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063423|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063424|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063425|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063426|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063432|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063433|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063434|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063435|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063436|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063437|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063438|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063439|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063440|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063441|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063442|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063443|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063444|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063445|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063446|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063447|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063448|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063449|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063450|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063451|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063452|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063453|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063454|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063455|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063456|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063457|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063458|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063459|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063460|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063461|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063462|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063463|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063464|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063465|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063466|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063467|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063468|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063469|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063470|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063471|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063472|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063473|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063474|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063475|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063476|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063477|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063478|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063479|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063480|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063481|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063482|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063483|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063484|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063485|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063486|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063487|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063488|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063489|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063490|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063491|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063492|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063493|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063494|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063495|NCT00660660|O2|Outcome|Placebo|Capsule once daily (QD)
1063496|NCT00660660|O1|Outcome|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063498|NCT00660660|E1|Reported Event|Nexium 20 mg|Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
1063499|NCT00660595|B3|Baseline|Total|Total of all reporting groups
1063500|NCT00660595|B2|Baseline|Risperdal|Risperidone, oral administration
1063501|NCT00660595|B1|Baseline|Seroquel|Quetiapine Prolong, oral administration
1063502|NCT00660595|P2|Participant Flow|Risperdal|Risperidone, oral administration
1063503|NCT00660595|P1|Participant Flow|Seroquel|Quetiapine Prolong, oral administration
1063504|NCT00660595|O2|Outcome|Risperdal|Risperidone, oral administration
1063505|NCT00660595|O1|Outcome|Seroquel|Quetiapine Prolong, oral administration
1063506|NCT00660595|O2|Outcome|Risperdal|Risperidone, oral administration
1063507|NCT00660595|O1|Outcome|Seroquel|Quetiapine Prolong, oral administration
1063508|NCT00660595|O2|Outcome|Risperdal|Risperidone, oral administration
1063509|NCT00660595|O1|Outcome|Seroquel|Quetiapine Prolong, oral administration
1063510|NCT00660595|O2|Outcome|Risperdal|Risperidone, oral administration
1063511|NCT00660595|O1|Outcome|Seroquel|Quetiapine Prolong, oral administration
1063512|NCT00660595|E2|Reported Event|Risperdal|Risperidone, oral administration
1063513|NCT00660595|E1|Reported Event|Seroquel|Quetiapine Prolong, oral administration
1063514|NCT00660543|B1|Baseline|Gadoteridol + Ferumoxytol Contrast Agent|Subjects all received gadolinium enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points.
1063515|NCT00660543|P1|Participant Flow|Gadoteridol + Ferumoxytol Contrast Agent|Subjects all received gadolinium enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points.
1063516|NCT00660543|O1|Outcome|Tumor Progression on Conventional MR|Tumor progression was assessed by RANO criteria (Wen, 2010).
1063517|NCT00660543|O3|Outcome|Gadoteridol Leakage Correction|Patients receive gadoteridol IV on day 1 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose).
1063518|NCT00660543|O2|Outcome|Gadoteridol|Patients receive gadoteridol IV on day 1 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose).
1063519|NCT00660543|O1|Outcome|Ferumoxytol|Patients receive gadolinium IV on day 1 and ferumoxytol non-stoichiometric magnetite IV on day 2 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose).
1063520|NCT00660543|E3|Reported Event|Gadoteridol With Leakage Correction|Subjects all received gadolinium enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points
1063521|NCT00660543|E2|Reported Event|Gadoteridol|Subjects all received gadolinium enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points
1063522|NCT00660543|E1|Reported Event|Ferumoxytol|Subjects all received ferumoxytol enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points
1063523|NCT00660517|B5|Baseline|Total|Total of all reporting groups
1063524|NCT00660517|B4|Baseline|Placebo|nasal spray
1063525|NCT00660517|B3|Baseline|Fluticasone Propionate 200 Mcg|fluticasone propionate nasal spray one spray per nostril two times a day
1063526|NCT00660517|B2|Baseline|Azelastine Hcl 548 Mcg|azelastine Hcl nasal spray one spray per nostril two times a day
1063527|NCT00660517|B1|Baseline|Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg|azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day
1063528|NCT00660517|P4|Participant Flow|Placebo|nasal spray
1063529|NCT00660517|P3|Participant Flow|Fluticasone Propionate 200 Mcg|fluticasone propionate nasal spray one spray per nostril two times a day
1063530|NCT00660517|P2|Participant Flow|Azelastine Hcl 548 Mcg|azelastine Hcl nasal spray one spray per nostril two times a day
1063531|NCT00660517|P1|Participant Flow|Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg|azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day
1063532|NCT00660517|O4|Outcome|Placebo|nasal spray
1063533|NCT00660517|O3|Outcome|Fluticasone Propionate 200 Mcg|fluticasone propionate nasal spray one spray per nostril two times a day
1063534|NCT00660517|O2|Outcome|Azelastine Hcl 548 Mcg|azelastine Hcl nasal spray one spray per nostril two times a day
1063535|NCT00660517|O1|Outcome|Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg|azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day
1063536|NCT00660517|O4|Outcome|Placebo|placebo nasal spray one spray per nostril two times a day
1063537|NCT00660517|O3|Outcome|Fluticasone Propionate 200 Mcg|fluticasone propionate nasal spray one spray per nostril two times a day
1063538|NCT00660517|O2|Outcome|Azelastine Hcl 548 Mcg|azelastine Hcl nasal spray one spray per nostril two times a day
1063539|NCT00660517|O1|Outcome|Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg|azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day
1063540|NCT00660517|O4|Outcome|Placebo|nasal spray
1063541|NCT00660517|O3|Outcome|Fluticasone Propionate 200 Mcg|fluticasone propionate nasal spray one spray per nostril two times a day
1063542|NCT00660517|O2|Outcome|Azelastine Hcl 548 Mcg|azelastine Hcl nasal spray one spray per nostril two times a day
1063543|NCT00660517|O1|Outcome|Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg|azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day
1063544|NCT00660517|E4|Reported Event|Placebo|nasal spray
1063545|NCT00660517|E3|Reported Event|Fluticasone Propionate 200 Mcg|fluticasone propionate nasal spray one spray per nostril two times a day
1063546|NCT00660517|E2|Reported Event|Azelastine Hcl 548 Mcg|azelastine Hcl nasal spray one spray per nostril two times a day
1063547|NCT00660517|E1|Reported Event|Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg|azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day
1063548|NCT00660504|B3|Baseline|Total|Total of all reporting groups
1063549|NCT00660504|B2|Baseline|Etoposide, Anticancer, Injection|
1063550|NCT00660504|B1|Baseline|Amrubicin, Anticancer, Injection|
1063551|NCT00660504|P2|Participant Flow|Etoposide Combined With Cisplatin Group|"Etoposide-Cisplatin combined chemotherapy~Etoposide-Cisplatin combined chemotherapy : combined chemotherapy"
1063552|NCT00660504|P1|Participant Flow|Amrubicin Combined With Cisplatin Group|"Amrubicin Hydrochloride-Cisplatin combined chemotherapy~Amrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin"
1063553|NCT00660504|O2|Outcome|Etoposide Combined With Cisplatin Group|"Etoposide-Cisplatin combined chemotherapy~Etoposide-Cisplatin combined chemotherapy : combined chemotherapy"
1063554|NCT00660504|O1|Outcome|Amrubicin Combined With Cisplatin Group|"Amrubicin Hydrochloride-Cisplatin combined chemotherapy~Amrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin"
1063555|NCT00660504|O2|Outcome|Etoposide Combined With Cisplatin Group|"Etoposide-Cisplatin combined chemotherapy~Etoposide-Cisplatin combined chemotherapy : combined chemotherapy"
1063556|NCT00660504|O1|Outcome|Amrubicin Combined With Cisplatin Group|"Amrubicin Hydrochloride-Cisplatin combined chemotherapy~Amrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin"
1063557|NCT00660504|O2|Outcome|Etoposide Combined With Cisplatin Group|"Etoposide-Cisplatin combined chemotherapy~Etoposide-Cisplatin combined chemotherapy : combined chemotherapy"
1063558|NCT00660504|O1|Outcome|Amrubicin Combined With Cisplatin Group|"Amrubicin Hydrochloride-Cisplatin combined chemotherapy~Amrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin"
1063559|NCT00660504|O2|Outcome|Etoposide Combined With Cisplatin Group|"Etoposide-Cisplatin combined chemotherapy~Etoposide-Cisplatin combined chemotherapy : combined chemotherapy"
1063560|NCT00660504|O1|Outcome|Amrubicin Combined With Cisplatin Group|"Amrubicin Hydrochloride-Cisplatin combined chemotherapy~Amrubicin Hydrochloride : Amrubicin Hydrochloride combined with cisplatin"
1063561|NCT00660504|E2|Reported Event|Etoposide, Anticancer, Injection|
1063562|NCT00660504|E1|Reported Event|Amrubicin, Anticancer, Injection|
1063563|NCT00660400|B1|Baseline|Combined Therapy|5-azacitidine therapy followed Allogeneic Hematopoietic Cell Transplantation (HCT).
1063564|NCT00660400|P1|Participant Flow|Combined Therapy|5-azacitidine therapy followed Allogeneic Hematopoietic Cell Transplantation (HCT).
1063565|NCT00660400|O1|Outcome|Combined Therapy|5-azacitidine therapy followed Allogeneic Hematopoietic Cell Transplantation (HCT).
1063566|NCT00660400|O1|Outcome|Combined Therapy|5-azacitidine therapy followed Allogeneic Hematopoietic Cell Transplantation (HCT).
1063567|NCT00660400|O1|Outcome|Combined Therapy|5-azacitidine therapy followed Allogeneic Hematopoietic Cell Transplantation (HCT).
1063568|NCT00660400|O1|Outcome|Combined Therapy|5-azacitidine therapy followed Allogeneic Hematopoietic Cell Transplantation (HCT).
1063569|NCT00660400|E1|Reported Event|Combined Therapy|5-azacitidine therapy followed Allogeneic Hematopoietic Cell Transplantation (HCT).
1063570|NCT00660387|B3|Baseline|Total|Total of all reporting groups
1063571|NCT00660387|B2|Baseline|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1063572|NCT00660387|B1|Baseline|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1063573|NCT00660387|P2|Participant Flow|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1063574|NCT00660387|P1|Participant Flow|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1063575|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1063576|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1063577|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1063578|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1063579|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1063580|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1063706|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
1063581|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1063582|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1063583|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1063584|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1063585|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1063586|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1063587|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1063588|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1063589|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1063590|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1063591|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1063592|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1063593|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1063594|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1063595|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1063596|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1063597|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1063598|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1063599|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1063600|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1063601|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1063602|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1063603|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1063604|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1063605|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1063606|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1063607|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1063608|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1063609|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1063610|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1063611|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1063612|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1063613|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1063614|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1063615|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1063616|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1063617|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1063618|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1063619|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1063620|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1063621|NCT00660387|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1063622|NCT00660387|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1063623|NCT00660387|E2|Reported Event|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1063624|NCT00660387|E1|Reported Event|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1063625|NCT00660348|B3|Baseline|Total|Total of all reporting groups
1063626|NCT00660348|B2|Baseline|Intrathecal Pump|"Pump internal used to deliver morphine. This is a newer method for delivery of morphine.~Medtronic intrathecal pump: This pump will be inserted into the research subject and then the pump will deliver morphine."
1063627|NCT00660348|B1|Baseline|Morphine|"morphine given traditionally (IV, pill, patch)~morphine sulfate: This is morphine given in the traditional methods."
1063628|NCT00660348|P2|Participant Flow|Intrathecal Pump|"Pump internal used to deliver morphine. This is a newer method for delivery of morphine.~Medtronic intrathecal pump: This pump will be inserted into the research subject and then the pump will deliver morphine."
1063629|NCT00660348|P1|Participant Flow|Morphine|"morphine given traditionally (IV, pill, patch)~morphine sulfate: This is morphine given in the traditional methods."
1063630|NCT00660348|O2|Outcome|Intrathecal Pump|"Pump internal used to deliver morphine. This is a newer method for delivery of morphine. Morphine is FDA approved for intrathecal use. The intrathecal pump will be titrated gradually to effect by the interventional pain medicine team. These are the maximum doses and concentrations in keeping with the Polyanalgesic Consensus Conference guidelines: Dose (mg/day):15 ; Conc (mg/cc): 20~Medtronic intrathecal pump: This pump will be inserted into the research subject and then the pump will deliver morphine."
1063631|NCT00660348|O1|Outcome|Morphine|"morphine given traditionally (IV, pill, patch). This is standard of care dosing.~morphine sulfate: This is morphine given in the traditional methods."
1063632|NCT00660348|E2|Reported Event|Intrathecal Pump|"Pump internal used to deliver morphine. This is a newer method for delivery of morphine.~Medtronic intrathecal pump: This pump will be inserted into the research subject and then the pump will deliver morphine."
1063633|NCT00660348|E1|Reported Event|Morphine|"morphine given traditionally (IV, pill, patch)~morphine sulfate: This is morphine given in the traditional methods."
1063634|NCT00660309|B3|Baseline|Total|Total of all reporting groups
1063635|NCT00660309|B2|Baseline|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
1063636|NCT00660309|B1|Baseline|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
1063637|NCT00660309|P2|Participant Flow|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
1063638|NCT00660309|P1|Participant Flow|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
1063639|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
1063640|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
1063641|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
1063642|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
1063643|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
1063644|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
1063645|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
1063646|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
1063647|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
1063648|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
1063649|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
1063650|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
1063651|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
1063652|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
1063653|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
1063654|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
1063655|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
1063656|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
1063657|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
1063658|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
1063659|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
1063660|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
1063661|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
1063662|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
1063663|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
1063664|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
1063665|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
1063666|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
1063667|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
1063668|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
1063669|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
1063670|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
1063671|NCT00660309|O2|Outcome|Irbesartan|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
1063672|NCT00660309|O1|Outcome|Aliskiren|On Day 1 participants received a single oral dose of 25 mg captopril. Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
1063673|NCT00660309|E3|Reported Event|Irbesartan 300 mg|Starting on Day 2 participants received irbesartan 300 mg tablets orally once a day for 14 days.
1063674|NCT00660309|E2|Reported Event|Aliskiren 300 mg|Starting on Day 2 participants received aliskiren 300 mg tablets orally once a day for 14 days.
1063675|NCT00660309|E1|Reported Event|Captopril 25 mg|On Day 1 participants received a single oral dose of 25 mg captopril.
1063676|NCT00660192|B3|Baseline|Total|Total of all reporting groups
1063677|NCT00660192|B2|Baseline|Botox|
1063678|NCT00660192|B1|Baseline|Placebo|
1063679|NCT00660192|P2|Participant Flow|Botox|Subjects randomized to receive 200-300units of onobotulinumtoxinA by injections into the scalp and neck muscles
1063680|NCT00660192|P1|Participant Flow|Placebo|Subjects randomized to placebo ho receive injections of 2cc's to 3cc's of saline solution. into muscle of the scalp and neck.
1063681|NCT00660192|O2|Outcome|Botullinum Toxin|Subjects injected with 100-200 units of botox depending on body and neck size
1063682|NCT00660192|O1|Outcome|Placebo|Inactive Saline
1063683|NCT00660192|O2|Outcome|Botullinum Toxin|Subjects injected with 100-200 units of botox depending on body and neck size
1063684|NCT00660192|O1|Outcome|Placebo|Inactive Saline
1063685|NCT00660192|E2|Reported Event|Botox|
1063686|NCT00660192|E1|Reported Event|Saline|
1063687|NCT00660179|B4|Baseline|Total|Total of all reporting groups
1063688|NCT00660179|B3|Baseline|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
1063689|NCT00660179|B2|Baseline|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
1063690|NCT00660179|B1|Baseline|Placebo|Matching ACT-064992 placebo tablet, once daily
1063691|NCT00660179|P3|Participant Flow|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
1063692|NCT00660179|P2|Participant Flow|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
1063693|NCT00660179|P1|Participant Flow|Placebo|Matching ACT-064992 placebo tablet, once daily
1063694|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
1063695|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
1063696|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
1063697|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
1063698|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
1063699|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
1063700|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
1063701|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
1063702|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
1063703|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
1063708|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
1063709|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
1063710|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
1063711|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
1063712|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
1063713|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
1063714|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
1063715|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
1063716|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
1063717|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
1063718|NCT00660179|O3|Outcome|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
1063719|NCT00660179|O2|Outcome|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
1063720|NCT00660179|O1|Outcome|Placebo|Matching ACT-064992 placebo tablet, once daily
1063721|NCT00660179|E3|Reported Event|ACT-064992 10 mg|ACT-064992 tablet, 10 mg, once daily
1063722|NCT00660179|E2|Reported Event|ACT-064992 3 mg|ACT-064992 tablet, 3 mg, once daily
1063723|NCT00660179|E1|Reported Event|Placebo|Matching ACT-064992 placebo tablet, once daily
1063724|NCT00660075|B3|Baseline|Total|Total of all reporting groups
1063725|NCT00660075|B2|Baseline|Placebo|Placebo for 6 weeks
1063726|NCT00660075|B1|Baseline|Sitagliptin|Sitagliptin 100 mg/d for 6 weeks
1063727|NCT00660075|P2|Participant Flow|Sitagliptin First, Then Placebo|Participants were first administered Sitagliptin 100 mg/d for 6 weeks followed by a washout period of 4 weeks and were then switched over to placebo for 6 weeks.
1063728|NCT00660075|P1|Participant Flow|Placebo First, Then Sitagliptin|Participants were first administered placebo for 6 weeks followed by a washout period of 4 weeks and were then switched over to Sitagliptin 100 mg/d for 6 weeks.
1063729|NCT00660075|O2|Outcome|Sitagliptin 100 mg/d|Sitagliptin 100 mg/d for 6 weeks
1063730|NCT00660075|O1|Outcome|Placebo|Placebo for 6 weeks
1063731|NCT00660075|E2|Reported Event|Placebo|Placebo for 6 weeks
1063732|NCT00660075|E1|Reported Event|Sitagliptin|Sitagliptin 100 mg/d for 6 weeks
1063733|NCT00660049|B1|Baseline|Open Label Single Arm Study|Eligible participants
1063734|NCT00660049|P1|Participant Flow|SNaP Application|"This is an open label pilot study of SMart Negative Pressure (SNaP) Advanced Wound Care System~SNaP Advanced Wound Care System: Application of negative pressure device daily per instructions~SNaP: Daily use~SNaP: Daily application per protocol"
1063735|NCT00660049|O1|Outcome|Open Label Single Arm Study|All participants who use the device
1063736|NCT00660049|E1|Reported Event|Eligible Participants|"This is an open label pilot study of SNaP Advanced Wound Care System~SNaP Advanced Wound Care System: Application of negative pressure device daily per instructions~SNaP: Daily use~SNaP: Daily application per protocol"
1063737|NCT00660023|B1|Baseline|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
1063738|NCT00660023|P1|Participant Flow|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with erythropoiesis-stimulating agent (ESA) therapy received intravenous methoxy polyethylene glycol-epoetin beta (Mircera), also known as continuous erythropoietin receptor activator (CERA), every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 micrograms (mcg) was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain hemoglobin (Hb) concentrations within target of 10.0 and 12.0 grams per deciliter (g/dL).
1063739|NCT00660023|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
1063740|NCT00660023|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
1063741|NCT00660023|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
1063742|NCT00660023|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
1063743|NCT00660023|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
1063789|NCT00659815|O2|Outcome|Clear Bottle ReNu MultiPlus Multi-Purpose Solution|Clear polyethylene terephthalate (PET) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care.
1063957|NCT00659438|B1|Baseline|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
1063958|NCT00659438|P2|Participant Flow|Placebo|Bicalutamide 150mg + placebo
1063744|NCT00660023|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
1063745|NCT00660023|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
1063746|NCT00660023|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
1063747|NCT00660023|E1|Reported Event|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA in the week preceding the switch to Mircera/CERA, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.0 and 12.0 g/dL.
1063748|NCT00660010|B1|Baseline|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
1063749|NCT00660010|P1|Participant Flow|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
1063750|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
1063751|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
1063752|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
1063753|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
1063754|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
1063755|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
1063756|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
1063757|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
1063758|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
1063759|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
1063760|NCT00660010|O1|Outcome|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
1063761|NCT00660010|E1|Reported Event|Leuprolide Acetate 1 Month Depot|Leuprolide acetate dosing was initiated at 300 mcg/kg (minimum dose 7.5 mg) administered intramuscularly (IM) every 28 days. Incremental adjustments to dosing at 3.75 mg increments were made at each visit.
1063762|NCT00659984|B1|Baseline|Ultratrace™ Iobenguane I 131|Eligible patients received a diagnostic imaging dose of Ultratrace™ Iobenguane I 131 (1-5 mCi) within 7 days of study enrollment, followed by three dosimetry scans over 3-6 days. If the imaging dose demonstrated normal biodistribution and tumor uptake, then the patient received a therapeutic dose within 7-28 days of the diagnostic imaging dose, followed by a single imaging scan on Day 7 post therapy. Therapeutic dosing began at 12.0 mCi/kg and escalated to 15.0, 18.0, and 21.0 mCi/kg until the MTD was established or the 21.0 mCi/kg dose level was reached. The dosimetry dose was administered over a period of 1-3 minutes by injection; the therapeutic dose was diluted in up to 25 mL normal saline and infused intravenously over 30 to 60 minutes.
1063790|NCT00659815|O1|Outcome|Marketed Bottle ReNu MultiPlus Multi-Purpose Solution|Currently Marketed high-density polyethylene (HDPE) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care.
1063791|NCT00659815|O2|Outcome|Clear Bottle ReNu MultiPlus Multi-Purpose Solution|Clear polyethylene terephthalate (PET) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care.
1063792|NCT00659815|O1|Outcome|Marketed Bottle ReNu MultiPlus Multi-Purpose Solution|Currently Marketed high-density polyethylene (HDPE) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care.
1063793|NCT00659815|E2|Reported Event|Clear Bottle ReNu MultiPlus Multi-Purpose Solution|Clear polyethylene terephthalate (PET) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care.
1063763|NCT00659984|P1|Participant Flow|Ultratrace™ Iobenguane I 131|"Eligible patients received a diagnostic imaging dose of Ultratrace™ Iobenguane I 131 within 7 days (d) of enrollment, followed by 3 dosimetry scans over 3-6 days. For the imaging dose, 0.1 mCi/kg (3.7 MBq/kg), at a min dose of 1 mCi (37 MBq) but not to exceed 5 mCi (185 MBq) of Ultratrace™ Iobenguane I 131 was administered 7-28 d prior to the therapeutic dose on Day 0. If the imaging dose demonstrated NL biodistribution/tumor uptake, pts received a therapeutic dose within 7-28 d of the imaging dose followed by a single imaging scan on Day 7 post therapy.~Therapeutic dosing was to begin at 12.0 mCi/kg and escalate to 15.0, 18.0, and 21.0 mCi/kg until the MTD was established or the 21.0 mCi/kg dose level was reached. Based on actual doses administered, pts were grouped into 3 mean dose groups: 11.2, 15.5, and 18.2 mCi/kg.~The dosimetry dose was administered over 1-3 mins by injection; the therapeutic dose was diluted in up to 25 mL normal saline and infused over 30 to 60 mins."
1063764|NCT00659984|O1|Outcome|Ultratrace™ Iobenguane I 131|Based on the actual doses administered, patients were grouped into 3 dose groups of 6, 3, and 6 patients, according to the mean doses of the groups, which were 11.2, 15.5, and 18.2 mCi/kg, respectively.
1063765|NCT00659984|O1|Outcome|Over Tumor Response|The proportion of patients who were considered successful defined as a patient achieving a Complete Response, Very Good Partial Response or Partial Response as determined by the Independent Reviewers.
1063766|NCT00659984|O1|Outcome|Ultratrace™ Iobenguane I 131|The proportion of patients who were considered successful defined as a patient achieving a Complete Response, Very Good Partial Response or Partial Response as determined by the Independent Reviewers.
1063767|NCT00659984|O1|Outcome|Ultratrace™ Iobenguane I 131|Following therapeutic dosing at the 12.0, 15.0, and 18.0 mCi/kg cohorts, 4 patients who were to receive the 21.0 mCi/kg therapeutic dose were required to have their planned dose reduced below the dose that was calculated based on the patient’s dosimetry results, in order to meet the protocol guidelines for maximal dosage allowed to normal organs described above. Because of the differences between the planned and actual therapeutic doses that were administered to several patients, patients were grouped and the study data were presented and analyzed by actual doses rather than by the planned dose cohorts of 12.0, 15.0, 18.0, and 21.0 mCi/kg. Based on the actual doses administered, patients were grouped into 3 dose groups of 6, 3, and 6 patients, according to the mean doses of the groups, which were 11.2, 15.5, and 18.2 mCi/kg, respectively.
1063768|NCT00659984|O3|Outcome|18.2 mCi Group|18.2 mCi/kg Ultratrace™ Iobenguane I 131 represents the mean dose administered to this group of subjects.
1063769|NCT00659984|O2|Outcome|15.5 mCi Group|15.5 mCi/kg Ultratrace™ Iobenguane I 131 represents the mean dose administered to this group of subjects.
1063770|NCT00659984|O1|Outcome|11.2 mCi Group|11.2 mCi/kg Ultratrace™ Iobenguane I 131 represents the mean dose administered to this group of subjects.
1063771|NCT00659984|O1|Outcome|Ultratrace™ Iobenguane I 131|Following therapeutic dosing at the 12.0, 15.0, and 18.0 mCi/kg cohorts, 4 patients who were to receive the 21.0 mCi/kg therapeutic dose were required to have their planned dose reduced below the dose that was calculated based on the patient’s dosimetry results, in order to meet the protocol guidelines for maximal dosage allowed to normal organs described above. Because of the differences between the planned and actual therapeutic doses that were administered to several patients, patients were grouped and the study data were presented and analyzed by actual doses rather than by the planned dose cohorts of 12.0, 15.0, 18.0, and 21.0 mCi/kg. Based on the actual doses administered, patients were grouped into 3 dose groups of 6, 3, and 6 patients, according to the mean doses of the groups, which were 11.2, 15.5, and 18.2 mCi/kg, respectively.
1063772|NCT00659984|E1|Reported Event|Ultratrace™ Iobenguane I 131|Eligible patients received a diagnostic imaging dose of Ultratrace™ Iobenguane I 131 (1-5 mCi) within 7 days of study enrollment, followed by three dosimetry scans over 3-6 days. If the imaging dose demonstrated normal biodistribution and tumor uptake, then the patient received a therapeutic dose within 7-28 days of the diagnostic imaging dose, followed by a single imaging scan on Day 7 post therapy. Mean therapeutic dosing groups were 11.2 mCi/kg, 15.5 nCi/kg and 18.2 mCi/kg. The dosimetry dose was administered over a period of 1-3 minutes by injection; the therapeutic dose was diluted in up to 25 mL normal saline and infused intravenously over 30 to 60 minutes.
1063773|NCT00659945|B3|Baseline|Total|Total of all reporting groups
1063774|NCT00659945|B2|Baseline|Group B(Oral Placebo+iv Ondansetron)|oral placebo plus intravenous ondansetron 4 mg IV
1063775|NCT00659945|B1|Baseline|Group A(Oral Aprepitant+iv Ondansetron)|oral aprepitant 40 mg plus intravenous ondansetron 4 mg
1063776|NCT00659945|P2|Participant Flow|Group B(Oral Placebo+iv Ondansetron)|oral placebo plus intravenous ondansetron 4 mg IV
1063777|NCT00659945|P1|Participant Flow|Group A(Oral Aprepitant+iv Ondansetron)|oral aprepitant 40 mg plus intravenous ondansetron 4 mg
1063778|NCT00659945|O2|Outcome|Group B(Oral Placebo+iv Ondansetron)|oral placebo plus intravenous ondansetron 4 mg IV
1063779|NCT00659945|O1|Outcome|Group A(Oral Aprepitant+iv Ondansetron)|oral aprepitant 40 mg plus intravenous ondansetron 4 mg
1063780|NCT00659945|E2|Reported Event|Group B(Oral Placebo+iv Ondansetron)|oral placebo plus intravenous ondansetron 4 mg IV
1063781|NCT00659945|E1|Reported Event|Group A(Oral Aprepitant+iv Ondansetron)|oral aprepitant 40 mg plus intravenous ondansetron 4 mg
1063782|NCT00659815|B3|Baseline|Total|Total of all reporting groups
1063783|NCT00659815|B2|Baseline|Clear Bottle ReNu MultiPlus Multi-Purpose Solution|Clear polyethylene terephthalate (PET) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care.
1063784|NCT00659815|B1|Baseline|Marketed Bottle ReNu MultiPlus Multi-Purpose Solution|Currently Marketed high-density polyethylene (HDPE) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care.
1063785|NCT00659815|P2|Participant Flow|Clear Bottle ReNu MultiPlus Multi-Purpose Solution|Clear polyethylene terephthalate (PET) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care.
1063786|NCT00659815|P1|Participant Flow|Marketed Bottle ReNu MultiPlus Multi-Purpose Solution|Currently Marketed high-density polyethylene (HDPE) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care.
1063787|NCT00659815|O2|Outcome|Clear Bottle ReNu MultiPlus Multi-Purpose Solution|Clear polyethylene terephthalate (PET) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month daily contact lens care.
1063788|NCT00659815|O1|Outcome|Marketed Bottle ReNu MultiPlus Multi-Purpose Solution|Currently Marketed high-density polyethylene (HDPE) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care.
1063794|NCT00659815|E1|Reported Event|Marketed Bottle ReNu MultiPlus Multi-Purpose Solution|Currently Marketed high-density polyethylene (HDPE) Bottle with B&L ReNu MultiPlus Multi-Purpose Solution for 1 month, daily contact lens care.
1063795|NCT00659789|B3|Baseline|Total|Total of all reporting groups
1063796|NCT00659789|B2|Baseline|Placebo Injections (Group II) While on ART|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
1063797|NCT00659789|B1|Baseline|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
1063798|NCT00659789|P2|Participant Flow|Placebo Injections (Group II) While on ART|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
1063799|NCT00659789|P1|Participant Flow|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
1063800|NCT00659789|O2|Outcome|Placebo Injections (Group II) While on ART.|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
1063801|NCT00659789|O1|Outcome|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
1063802|NCT00659789|O2|Outcome|Placebo Injections (Group II) While on ART.|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
1063803|NCT00659789|O1|Outcome|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
1063804|NCT00659789|O2|Outcome|Placebo Injections (Group II) While on ART.|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
1063805|NCT00659789|O1|Outcome|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
1063806|NCT00659789|O2|Outcome|Placebo Injections (Group II) While on ART.|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
1063807|NCT00659789|O1|Outcome|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
1063808|NCT00659789|O2|Outcome|Placebo Injections (Group II) While on ART.|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
1063809|NCT00659789|O1|Outcome|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
1063810|NCT00659789|O2|Outcome|Placebo Injections (Group II) While on ART.|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
1063811|NCT00659789|O1|Outcome|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
1063812|NCT00659789|E2|Reported Event|Placebo Injections (Group II) While on ART|Placebo Vacc-4x (with placebo Leukine®) at Weeks 1, 2, 3, 4, 16 and 18.
1063813|NCT00659789|E1|Reported Event|Vacc-4x Immunization (Adjuvant: GM-CSF) (Group I) While on ART|Immunization with Vacc-4x (with Leukine®) at Weeks 1, 2, 3, and 4 followed by booster immunizations at Weeks 16 and 18.
1063814|NCT00659737|B3|Baseline|Total|Total of all reporting groups
1063815|NCT00659737|B2|Baseline|Aprepitant and Scopolamine Transdermal Patch|Oral Aprepitant pill, 40 mg tablet and Scopolamine transdermal patch, 1.5 mg patch delivering transdermally in vivo approximately 1.0mg over 3 days, at least 1 hour prior to surgical procedure
1063816|NCT00659737|B1|Baseline|Aprepitant and Placebo Transdermal Patch|Oral Aprepitant pill, 40 mg tablet and placebo transdermal patch at least 1 hour prior to surgical procedure.
1063817|NCT00659737|P2|Participant Flow|Aprepitant and Scopolamine Transdermal Patch|Oral Aprepitant pill, 40 mg tablet and Scopolamine transdermal patch, 1.5 mg patch delivering transdermally in vivo approximately 1.0mg over 3 days, at least 1 hour prior to surgical procedure.
1063818|NCT00659737|P1|Participant Flow|Aprepitant and Placebo Transdermal Patch|Oral Aprepitant pill 40 mg tablet and placebo transdermal patch at least 1 hour prior to surgical procedure.
1063819|NCT00659737|O2|Outcome|Aprepitant and Scopolamine Transdermal Patch|Oral Aprepitant pill, 40 mg tablet and Scopolamine transdermal patch, 1.5 mg patch delivering transdermally in vivo approximately 1.0mg over 3 days, at least 1 hour prior to surgical procedure
1063820|NCT00659737|O1|Outcome|Aprepitant and Placebo Transdermal Patch|Oral Aprepitant pill, 40 mg tablet and placebo transdermal patch at least 1 hour prior to surgical procedure.
1063821|NCT00659737|E2|Reported Event|Scopolamine|"Oral Aprepitant pill and Scopolamine transdermal patch at least 1 hour prior to surgical procedure.~Scopolamine + Emend (Aprepitant): 1.5 mg patch delivering transdermally in vivo approx. 1.0mg over 3 days"
1063822|NCT00659737|E1|Reported Event|Aprepiatnt|"Oral Aprepitant pill and placebo transdermal patch at least 1 hour prior to surgical procedure.~Emend (Aprepitant) + Placebo: 40mg tablet"
1063823|NCT00659724|B1|Baseline|Hemodialysis Patients|Hemodialysis patients 18 years of age or older receiving routine dialysis treatment for chronic renal failure.
1063824|NCT00659724|P1|Participant Flow|Hemodialysis Patients|Hemodialysis patients 18 years of age or older receiving routine dialysis treatment for chronic renal failure.
1063825|NCT00659724|O3|Outcome|Optiflux F200NR|
1063826|NCT00659724|O2|Outcome|Optiflux F180NR|
1063827|NCT00659724|O1|Outcome|Revaclear MAX|
1063828|NCT00659724|O3|Outcome|Optiflux F200NR|
1063829|NCT00659724|O2|Outcome|Optiflux F180NR|
1063830|NCT00659724|O1|Outcome|Revaclear MAX|
1063831|NCT00659724|O3|Outcome|Optiflux F200NR|
1063832|NCT00659724|O2|Outcome|Optiflux F180NR|
1063833|NCT00659724|O1|Outcome|Revaclear MAX|
1063834|NCT00659724|O3|Outcome|Optiflux F200NR|
1063835|NCT00659724|O2|Outcome|Optiflux F180NR|
1063836|NCT00659724|O1|Outcome|Revaclear MAX|
1063837|NCT00659724|O3|Outcome|Optiflux F200NR|
1063838|NCT00659724|O2|Outcome|Optiflux F180NR|
1063839|NCT00659724|O1|Outcome|Revaclear MAX|
1063840|NCT00659724|E1|Reported Event|Hemodialysis Patients|Hemodialysis patients 18 years of age or older receiving routine dialysis treatment for chronic renal failure.
1063956|NCT00659438|B2|Baseline|Placebo|Bicalutamide 150mg + placebo
1063841|NCT00659633|B1|Baseline|Lidocaine|"Intravenous lidocaine for neuropathic pain~lidocaine: intravenous, effect site concentration: 2mcg/ml, 15-20 min infusion, once"
1063842|NCT00659633|P1|Participant Flow|Lidocaine|"Intravenous lidocaine for neuropathic pain~lidocaine: intravenous, effect site concentration: 2mcg/ml, 15-20 min infusion, once"
1063843|NCT00659633|O1|Outcome|Lidocaine|"Intravenous lidocaine for neuropathic pain~lidocaine: intravenous, effect site concentration: 2mcg/ml, 15-20 min infusion, once"
1063844|NCT00659633|E1|Reported Event|Lidocaine|"Intravenous lidocaine for neuropathic pain~lidocaine: intravenous, effect site concentration: 2mcg/ml, 15-20 min infusion, once"
1063845|NCT00659607|B1|Baseline|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
1063846|NCT00659607|P1|Participant Flow|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
1063847|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3932/ The number of patients for efficacy assessment: 3616.
1063848|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3932/ The number of patients for efficacy assessment: 3616.
1063849|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
1063850|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
1063851|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
1063852|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
1063853|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
1063854|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
1063855|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
1063856|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
1063857|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
1063858|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
1063859|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
1063860|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
1063861|NCT00659607|O1|Outcome|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
1063862|NCT00659607|E1|Reported Event|Hypertensive Patients With Micardis Plus for the First Time|In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
1063863|NCT00659581|B1|Baseline|Telmisartan|
1063864|NCT00659581|P1|Participant Flow|Telmisartan|
1063865|NCT00659581|O1|Outcome|Telmisartan|
1063866|NCT00659581|O1|Outcome|Telmisartan|
1063867|NCT00659581|O1|Outcome|Telmisartan|
1063868|NCT00659581|O1|Outcome|Telmisartan|
1063869|NCT00659581|O1|Outcome|Telmisartan|
1063870|NCT00659581|O1|Outcome|Telmisartan|
1063871|NCT00659581|O1|Outcome|Telmisartan|
1063872|NCT00659581|O1|Outcome|Telmisartan|
1063873|NCT00659581|O1|Outcome|Telmisartan|
1063874|NCT00659581|E1|Reported Event|Telmisartan|
1063875|NCT00659529|B1|Baseline|Open-label (All Subjects)|"All subjects will receive oral sildenafil three times per day during the study. Study endpoints will be measured before the treatment period and at the end of the treatment period.~sildenafil: Sildenafil will be given 20mg po tid for 1 week, and then will be give 40mg po tid for 5 weeks."
1063876|NCT00659529|P1|Participant Flow|Open-label (All Subjects)|"All subjects will receive oral sildenafil three times per day during the study. Study endpoints will be measured before the treatment period and at the end of the treatment period.~sildenafil: Sildenafil will be given 20mg po tid for 1 week, and then will be give 40mg po tid for 5 weeks."
1063877|NCT00659529|O1|Outcome|Open-label (All Subjects)|"All subjects will receive oral sildenafil three times per day during the study. Study endpoints will be measured before the treatment period and at the end of the treatment period.~sildenafil: Sildenafil will be given 20mg po tid for 1 week, and then will be give 40mg po tid for 5 weeks."
1063878|NCT00659529|E1|Reported Event|Open-label (All Subjects)|"All subjects will receive oral sildenafil three times per day during the study. Study endpoints will be measured before the treatment period and at the end of the treatment period.~sildenafil: Sildenafil will be given 20mg po tid for 1 week, and then will be give 40mg po tid for 5 weeks."
1063879|NCT00659490|B4|Baseline|Total|Total of all reporting groups
1063880|NCT00659490|B3|Baseline|Naproxen|Naproxen 500mg given pre-surgery
1063881|NCT00659490|B2|Baseline|Placebo|Placebo given pre-surgery
1063882|NCT00659490|B1|Baseline|AZD1940|AZD1940 800ug given predose
1063883|NCT00659490|P3|Participant Flow|Naproxen|Naproxen 500mg given pre-surgery
1063884|NCT00659490|P2|Participant Flow|Placebo|Placebo given pre-surgery
1063885|NCT00659490|P1|Participant Flow|AZD1940|AZD1940 800ug given predose
1063886|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
1063887|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
1063888|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
1063889|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
1063890|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
1063891|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
1063892|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
1063893|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
1063894|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
1063895|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
1063896|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
1063897|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
1063898|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
1063899|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
1063900|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
1063901|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
1063902|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
1063903|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
1063904|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
1063905|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
1063906|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
1063907|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
1063908|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
1063909|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
1063910|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
1063911|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
1063912|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
1063913|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
1063914|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
1063915|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
1063916|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
1063917|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
1063918|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
1063919|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
1063920|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
1063921|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
1063922|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
1063923|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
1063924|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
1063925|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
1063926|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
1063927|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
1063928|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
1063929|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
1063930|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
1063931|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
1063932|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
1063933|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
1063934|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
1063935|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
1063936|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
1063937|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
1063938|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
1063939|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
1063940|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
1063941|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
1063942|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
1063943|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
1063944|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
1063945|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
1063946|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
1063947|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
1063948|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
1063949|NCT00659490|O3|Outcome|Naproxen|Naproxen 500mg given pre-surgery
1063950|NCT00659490|O2|Outcome|Placebo|Placebo given pre-surgery
1063951|NCT00659490|O1|Outcome|AZD1940|AZD1940 800ug given predose
1063952|NCT00659490|E3|Reported Event|Naproxen|Naproxen 500mg given pre-surgery
1063953|NCT00659490|E2|Reported Event|Placebo|Placebo given pre-surgery
1063954|NCT00659490|E1|Reported Event|AZD1940|AZD1940 800ug given predose
1063955|NCT00659438|B3|Baseline|Total|Total of all reporting groups
1063959|NCT00659438|P1|Participant Flow|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
1063960|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
1063961|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
1063962|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
1063963|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
1063964|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
1063965|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
1063966|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
1063967|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
1063968|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
1063969|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
1063970|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
1063971|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
1063972|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
1063973|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
1063974|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
1063975|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
1063976|NCT00659438|O2|Outcome|Placebo|Bicalutamide 150mg + placebo
1063977|NCT00659438|O1|Outcome|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
1063978|NCT00659438|E2|Reported Event|Placebo|Bicalutamide 150mg + placebo
1063979|NCT00659438|E1|Reported Event|Vandetanib|Bicalutamide 150mg + Vandetanib (ZD6474) 300mg
1063980|NCT00659373|B3|Baseline|Total|Total of all reporting groups
1063981|NCT00659373|B2|Baseline|Ovarian Function Suppression|"Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation).~Note: Data were collected separately for the T+OFS and E+OFS participants in the parent study, IBCSG 24-02 (SOFT). The sample size for this Co-SOFT substudy was small, so the analysis plan was revised to pre-specify collective analysis for all patients receiving OFS."
1063982|NCT00659373|B1|Baseline|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
1063983|NCT00659373|P2|Participant Flow|Ovarian Function Suppression|Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
1063984|NCT00659373|P1|Participant Flow|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
1063985|NCT00659373|O2|Outcome|Ovarian Function Suppression|"Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)~Note: Data were collected separately for the T+OFS and E+OFS participants in the parent study, IBCSG 24-02 (SOFT). The sample size for this Co-SOFT substudy was small, so the analysis plan was revised to pre-specify collective analysis for all patients receiving OFS."
1063986|NCT00659373|O1|Outcome|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
1063987|NCT00659373|E2|Reported Event|Ovarian Function Suppression|Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
1063988|NCT00659373|E1|Reported Event|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
1063989|NCT00659360|B1|Baseline|Arm I|"Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
1063990|NCT00659360|P1|Participant Flow|Arm I AZD0530|"Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
1063991|NCT00659360|O1|Outcome|Arm I|"Patients receive oral AZD0530 (saracatinib ) at a dose of 175 mg, once daily, in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
1063992|NCT00659360|O1|Outcome|Arm I|"Patients receive oral AZD0530 (saracatinib ) at a dose of 175 mg, once daily, in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
1063993|NCT00659360|O1|Outcome|Arm I|"Patients receive oral AZD0530 (saracatinib ) at a dose of 175 mg, once daily, in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
1063994|NCT00659360|O1|Outcome|Arm I|"Patients receive oral AZD0530 (saracatinib ) at a dose of 175 mg, once daily, in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
1063995|NCT00659360|O1|Outcome|Arm I|"Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
1063996|NCT00659360|E1|Reported Event|Arm I|"Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
1063997|NCT00659334|B8|Baseline|Total|Total of all reporting groups
1063998|NCT00659334|B7|Baseline|Inflammatory Lesions (Group 7)|Adults with Inflammatory lesions (stroke or MS) to receive Combidex only
1063999|NCT00659334|B6|Baseline|Neurosurgery Only (Group 6)|Children with brain tumors to receive neurosurgery only, NO Combidex
1064000|NCT00659334|B5|Baseline|Combidex and Neurosurgery (Group 5)|Children with brain tumors to receive Combidex and neurosurgery
1064001|NCT00659334|B4|Baseline|Combidex Only (Group 4)|Children with brain tumors to receive Combidex only
1064002|NCT00659334|B3|Baseline|Neurosurgery Only (Group 3)|Adults with brain tumors to receive neurosurgery only (NO Combidex)
1064003|NCT00659334|B2|Baseline|Combidex and Neurosurgery (Group 2)|Adults with brain tumors to receive Combidex infusion and neurosurgery
1064004|NCT00659334|B1|Baseline|Combidex Only (Group 1)|Adults with brain tumor to receive Combidex infusion only
1064005|NCT00659334|P7|Participant Flow|Inflammatory Lesions (Group 7)|Adults with Inflammatory lesions (stroke or MS) to receive Combidex only
1064006|NCT00659334|P6|Participant Flow|Neurosurgery Only (Group 6)|Children with brain tumors to receive neurosurgery only, NO Combidex
1064007|NCT00659334|P5|Participant Flow|Combidex and Neurosurgery (Group 5)|Children with brain tumors to receive Combidex and neurosurgery
1075895|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
1064008|NCT00659334|P4|Participant Flow|Combidex Only (Group 4)|Children with brain tumors to receive Combidex only
1064009|NCT00659334|P3|Participant Flow|Neurosurgery Only (Group 3)|Adults with brain tumors to receive neurosurgery only (NO Combidex)
1064010|NCT00659334|P2|Participant Flow|Combidex and Neurosurgery (Group 2)|Adults with brain tumors to receive Combidex infusion and neurosurgery
1064011|NCT00659334|P1|Participant Flow|Combidex Only (Group 1)|Adults with brain tumor to receive Combidex infusion only
1064012|NCT00659334|O7|Outcome|Inflammatory Lesions (Group 7)|Adults with Inflammatory lesions (stroke or MS) to receive Combidex only
1064013|NCT00659334|O6|Outcome|Neurosurgery Only (Group 6)|Children with brain tumors to receive neurosurgery only, NO Combidex
1064014|NCT00659334|O5|Outcome|Combidex and Neurosurgery (Group 5)|Children with brain tumors to receive Combidex and neurosurgery
1064015|NCT00659334|O4|Outcome|Combidex Only (Group 4)|Children with brain tumors to receive Combidex only
1064016|NCT00659334|O3|Outcome|Neurosurgery Only (Group 3)|Adults with brain tumors to receive neurosurgery only (NO Combidex)
1064017|NCT00659334|O2|Outcome|Combidex and Neurosurgery (Group 2)|Adults with brain tumors to receive Combidex infusion and neurosurgery
1064018|NCT00659334|O1|Outcome|Combidex Only (Group 1)|Adults with brain tumor to receive Combidex infusion only
1064019|NCT00659334|E7|Reported Event|Inflammatory Lesions (Group 7)|Adults with Inflammatory lesions (stroke or MS) to receive Combidex only
1064020|NCT00659334|E6|Reported Event|Neurosurgery Only (Group 6)|Children with brain tumors to receive neurosurgery only, NO Combidex
1064021|NCT00659334|E5|Reported Event|Combidex and Neurosurgery (Group 5)|Children with brain tumors to receive Combidex and neurosurgery
1064022|NCT00659334|E4|Reported Event|Combidex Only (Group 4)|Children with brain tumors to receive Combidex only
1064023|NCT00659334|E3|Reported Event|Neurosurgery Only (Group 3)|Adults with brain tumors to receive neurosurgery only (NO Combidex)
1064024|NCT00659334|E2|Reported Event|Combidex and Neurosurgery (Group 2)|Adults with brain tumors to receive Combidex infusion and neurosurgery
1064025|NCT00659334|E1|Reported Event|Combidex Only (Group 1)|Adults with brain tumor to receive Combidex infusion only
1064026|NCT00659295|B3|Baseline|Total|Total of all reporting groups
1064027|NCT00659295|B2|Baseline|Type 2 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
1064028|NCT00659295|B1|Baseline|Type 1 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
1064029|NCT00659295|P2|Participant Flow|Type 2 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
1064030|NCT00659295|P1|Participant Flow|Type 1 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
1064031|NCT00659295|O2|Outcome|Type 2 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
1064032|NCT00659295|O1|Outcome|Type 1 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
1064033|NCT00659295|E2|Reported Event|Type 2 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
1064034|NCT00659295|E1|Reported Event|Type 1 Diabetes|Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.
1064035|NCT00659269|B3|Baseline|Total|Total of all reporting groups
1064036|NCT00659269|B2|Baseline|Multivitamin + Vitamin B12 + Vitamin B6|"Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Cumulative doses (in mg/m2) are:~paclitaxel, 700; docetaxel, 300; vincristine, 16; navelbine, 480; cisplatin, 300; oxaliplatin, 400"
1064037|NCT00659269|B1|Baseline|Multivitamin (MV)|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)"
1064038|NCT00659269|P2|Participant Flow|Multivitamin + Vitamin B12 + Vitamin B6|"Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Cumulative doses (in mg/m2) are:~paclitaxel, 700; docetaxel, 300; vincristine, 16; navelbine, 480; cisplatin, 300; oxaliplatin, 400"
1073275|NCT00631748|O2|Outcome|Placebo|matched placebo (sugar pill)
1064039|NCT00659269|P1|Participant Flow|Multivitamin (MV)|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)"
1064040|NCT00659269|O6|Outcome|Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~vincristine, 8-16; vinorelbine, 360-480"
1064041|NCT00659269|O5|Outcome|Vinca Alkaloids Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~vincristine, 8-16; vinorelbine, 360-480"
1064042|NCT00659269|O4|Outcome|Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~cisplatin, 240-400; oxaliplatin, 400-800"
1064043|NCT00659269|O3|Outcome|Heavy Metals Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~cisplatin, 240-400; oxaliplatin, 400-800"
1064044|NCT00659269|O2|Outcome|Taxane Group: MV + Vitamin B12 + Vitamin B6|"Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800"
1064045|NCT00659269|O1|Outcome|Taxane Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~paclitaxel, 700-960; docetaxel, abraxane, 1200-1800"
1064046|NCT00659269|O6|Outcome|Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~vincristine, 8-16; vinorelbine, 360-480"
1064047|NCT00659269|O5|Outcome|Vinca Alkaloids Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~vincristine, 8-16; vinorelbine, 360-480"
1064048|NCT00659269|O4|Outcome|Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~cisplatin, 240-400; oxaliplatin, 400-800"
1064049|NCT00659269|O3|Outcome|Heavy Metals Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~cisplatin, 240-400; oxaliplatin, 400-800"
1064094|NCT00659061|P1|Participant Flow|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
1064391|NCT00658619|B5|Baseline|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
1064050|NCT00659269|O2|Outcome|Multivitamin + Vitamin B12 + Vitamin B6|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800"
1064051|NCT00659269|O1|Outcome|Taxane Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800"
1064052|NCT00659269|O6|Outcome|Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~vincristine, 8-16; vinorelbine, 360-480"
1064053|NCT00659269|O5|Outcome|Vinca Alkaloids Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~vincristine, 8-16; vinorelbine, 360-480"
1064054|NCT00659269|O4|Outcome|Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~cisplatin, 240-400; oxaliplatin, 400-800"
1064055|NCT00659269|O3|Outcome|Heavy Metals Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~cisplatin, 240-400; oxaliplatin, 400-800"
1064056|NCT00659269|O2|Outcome|Taxane Group: MV + Vitamin B12 + Vitamin B6|"Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800"
1064057|NCT00659269|O1|Outcome|Taxane Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800"
1064058|NCT00659269|O6|Outcome|Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~vincristine, 8-16; vinorelbine, 360-480"
1064059|NCT00659269|O5|Outcome|Vinca Alkaloids Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Cumulative doses for chemotherapy (in mg/m2) are:~vincristine, 8-16; vinorelbine, 360-480"
1064060|NCT00659269|O4|Outcome|Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~cisplatin, 240-400; oxaliplatin, 400-800"
1064061|NCT00659269|O3|Outcome|Heavy Metals Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Cumulative doses for chemotherapy (in mg/m2) are:~cisplatin, 240-400; oxaliplatin, 400-800"
1064062|NCT00659269|O2|Outcome|Taxane Group: MV + Vitamin B12 + Vitamin B6|"Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Ranges of cumulative doses (in mg/m2) are:~paclitaxel, 700-960; docetaxel, 240-400"
1064063|NCT00659269|O1|Outcome|Taxane Group: Multivitamin (MV) Arm|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Ranges of cumulative doses (in mg/m2) are:~paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800"
1064064|NCT00659269|E2|Reported Event|Multivitamin + Vitamin B12 + Vitamin B6|"Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections~Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).~The patient will also take the following, starting on the first day of chemotherapy:~pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)~Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.~Cumulative doses (in mg/m2) are:~paclitaxel, 700; docetaxel, 300; vincristine, 16; navelbine, 480; cisplatin, 300; oxaliplatin, 400"
1064065|NCT00659269|E1|Reported Event|Multivitamin (MV)|"Multivitamin only~Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.~1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)"
1064066|NCT00659230|B3|Baseline|Total|Total of all reporting groups
1064067|NCT00659230|B2|Baseline|Nepicastat|"Arm 2~Nepicastat: 100-800mg"
1064068|NCT00659230|B1|Baseline|Placebo|"Arm 1~Placebo: 100-800mg placebo"
1064069|NCT00659230|P2|Participant Flow|Nepicastat|"Arm 2~Nepicastat: 100-800mg"
1064070|NCT00659230|P1|Participant Flow|Placebo|"Arm 1~Placebo: 100-800mg placebo"
1064071|NCT00659230|O2|Outcome|Nepicastat|"Arm 2~Nepicastat: 100-800mg"
1064072|NCT00659230|O1|Outcome|Placebo|"Arm 1~Placebo: 100-800mg placebo"
1064073|NCT00659230|O2|Outcome|Nepicastat|"Arm 2~Nepicastat: 100-800mg"
1064074|NCT00659230|O1|Outcome|Placebo|"Arm 1~Placebo: 100-800mg placebo"
1064075|NCT00659230|O2|Outcome|Nepicastat|"Arm 2~Nepicastat: 100-800mg"
1064076|NCT00659230|O1|Outcome|Placebo|"Arm 1~Placebo: 100-800mg placebo"
1064077|NCT00659230|O2|Outcome|Nepicastat|"Arm 2~Nepicastat: 100-800mg"
1064078|NCT00659230|O1|Outcome|Placebo|"Arm 1~Placebo: 100-800mg placebo"
1064079|NCT00659230|E2|Reported Event|Nepicastat|"Arm 2~Nepicastat: 100-800mg"
1064080|NCT00659230|E1|Reported Event|Placebo|"Arm 1~Placebo: 100-800mg placebo"
1064081|NCT00659165|B3|Baseline|Total|Total of all reporting groups
1064082|NCT00659165|B2|Baseline|Insulin Glargine|These people receive insulin glargine first, then insulin detemir. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
1064083|NCT00659165|B1|Baseline|Insulin Detemir|These people receive insulin detemir first, then insulin glargine. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
1064084|NCT00659165|P2|Participant Flow|Insulin Glargine|These people receive insulin glargine first, then insulin detemir. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
1064085|NCT00659165|P1|Participant Flow|Insulin Detemir|These people receive insulin detemir first, then insulin glargine. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
1064086|NCT00659165|O2|Outcome|Insulin Glargine|These people receive insulin glargine first, then insulin detemir. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
1064087|NCT00659165|O1|Outcome|Insulin Detemir|These people receive insulin detemir first, then insulin glargine. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
1064088|NCT00659165|E2|Reported Event|Insulin Glargine|These people receive insulin glargine first, then insulin detemir. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
1064089|NCT00659165|E1|Reported Event|Insulin Detemir|These people receive insulin detemir first, then insulin glargine. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.
1064090|NCT00659061|B3|Baseline|Total|Total of all reporting groups
1064091|NCT00659061|B2|Baseline|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
1064092|NCT00659061|B1|Baseline|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
1064093|NCT00659061|P2|Participant Flow|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
1064628|NCT00657280|O1|Outcome|Sitagliptin|There is only one group. All the participants took the Sitagliptin.
1064095|NCT00659061|O2|Outcome|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
1064096|NCT00659061|O1|Outcome|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
1064097|NCT00659061|O2|Outcome|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
1064098|NCT00659061|O1|Outcome|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
1064099|NCT00659061|O2|Outcome|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
1064100|NCT00659061|O1|Outcome|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
1064101|NCT00659061|O2|Outcome|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
1064102|NCT00659061|O1|Outcome|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
1064103|NCT00659061|O2|Outcome|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
1064104|NCT00659061|O1|Outcome|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
1064105|NCT00659061|O2|Outcome|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
1064106|NCT00659061|O1|Outcome|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
1064107|NCT00659061|O2|Outcome|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
1064108|NCT00659061|O1|Outcome|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
1064109|NCT00659061|O2|Outcome|Advice Only|Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
1064110|NCT00659061|O1|Outcome|Sprinkle-Advice|Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
1064111|NCT00658996|B1|Baseline|Entire Study Population|Population enrolled at start of study
1064112|NCT00658996|P2|Participant Flow|Focus Dailies Toric First, Then SofLens DD Toric|Ciba Vision Focus Dailies Toric Lens first, then crossover to Bausch & Lomb SofLens Daily Disposable Toric Contact Lens
1064113|NCT00658996|P1|Participant Flow|SofLens DD Toric First, Then Focus Dailies Toric|Bausch & Lomb SofLens Daily Disposable Toric Contact Lens first then crossover to Ciba Vision Focus Dailies Toric Lens
1064114|NCT00658996|O2|Outcome|Focus Dailies Toric|Ciba Vision Focus Dailies Toric contact lenses
1064115|NCT00658996|O1|Outcome|SofLens DD Toric|Bausch & Lomb SofLens Daily Disposable Toric Contact Lens
1064116|NCT00658996|O2|Outcome|Focus Dailies Toric|Ciba Vision Focus Dailies Toric contact lenses
1064117|NCT00658996|O1|Outcome|SofLens DD Toric|Bausch & Lomb SofLens Daily Disposable Toric Contact Lens
1064118|NCT00658996|O2|Outcome|Focus Dailies Toric|Ciba Vision Focus Dailies Toric contact lenses
1064119|NCT00658996|O1|Outcome|SofLens DD Toric|Bausch & Lomb SofLens Daily Disposable Toric Contact Lens
1064120|NCT00658996|E2|Reported Event|Ciba Vision Toric Lens|Ciba Vision Focus Dailies Toric Lens
1064121|NCT00658996|E1|Reported Event|SofLens DD Toric|Bausch & Lomb SofLens Daily Disposable Toric Contact Lens
1064122|NCT00658814|B3|Baseline|Total|Total of all reporting groups
1064123|NCT00658814|B2|Baseline|Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
1064124|NCT00658814|B1|Baseline|Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
1064125|NCT00658814|P2|Participant Flow|Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Patients achieving complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) go on to receive consolidation therapy.~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Patients in continued remission may go on to receive maintenance therapy.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
1064126|NCT00658814|P1|Participant Flow|Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Patients achieving complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) go on to receive consolidation therapy.~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Patients in continued remission may go on to receive maintenance therapy.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
1064127|NCT00658814|O2|Outcome|Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
1064128|NCT00658814|O1|Outcome|Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
1064129|NCT00658814|O2|Outcome|Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
1064130|NCT00658814|O1|Outcome|Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
1064131|NCT00658814|O2|Outcome|Poor Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Poor risk patients defined as those who were at least 70 years old and had a performance status of 2 or 3.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
1064132|NCT00658814|O1|Outcome|Good Risk Patients: Azacitidine Plus Gemtuzumab Ozogamicin|"Good risk patients defined as those aged 60-69 or those with performance status of Zubrod 0-1.~Remission Induction: Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)~Consolidation: Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.~Maintenance: Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)"
1064133|NCT00658814|O3|Outcome|Maintenance Therapy|Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)
1064134|NCT00658814|O2|Outcome|Consolidation Therapy|Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
1064135|NCT00658814|O1|Outcome|Remission Induction Chemotherapy|Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
1064136|NCT00658814|E3|Reported Event|Maintenance Therapy|Azacitidine subcutaneously on days 1-7 (1 cycle = 28 days)
1064137|NCT00658814|E2|Reported Event|Consolidation Therapy|Azacitidine subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8.
1064138|NCT00658814|E1|Reported Event|Remission Induction Chemotherapy|Azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. (1 cycle = 14 days)
1064139|NCT00658788|B1|Baseline|Sequential Treatment Regimen|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
1064140|NCT00658788|P1|Participant Flow|Sequential Treatment Regimen|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
1064141|NCT00658788|O5|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064142|NCT00658788|O4|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064143|NCT00658788|O3|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064144|NCT00658788|O2|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064145|NCT00658788|O1|Outcome|Baseline|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064146|NCT00658788|O5|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064147|NCT00658788|O4|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064148|NCT00658788|O3|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064149|NCT00658788|O2|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1073276|NCT00631748|O1|Outcome|Study Drug|Quetiapine (Seroquel XR)
1064150|NCT00658788|O1|Outcome|Baseline|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064151|NCT00658788|O5|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064152|NCT00658788|O4|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064153|NCT00658788|O3|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064154|NCT00658788|O2|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064155|NCT00658788|O1|Outcome|Baseline|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064156|NCT00658788|O5|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064157|NCT00658788|O4|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064158|NCT00658788|O3|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064159|NCT00658788|O2|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064160|NCT00658788|O1|Outcome|Baseline|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064161|NCT00658788|O5|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064162|NCT00658788|O4|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064163|NCT00658788|O3|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064164|NCT00658788|O2|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064165|NCT00658788|O1|Outcome|Baseline|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064166|NCT00658788|O4|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064167|NCT00658788|O3|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064168|NCT00658788|O2|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064169|NCT00658788|O1|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064170|NCT00658788|O4|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064171|NCT00658788|O3|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064172|NCT00658788|O2|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064173|NCT00658788|O1|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064174|NCT00658788|O4|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064175|NCT00658788|O3|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064176|NCT00658788|O2|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064177|NCT00658788|O1|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064178|NCT00658788|O4|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064179|NCT00658788|O3|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064180|NCT00658788|O2|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064181|NCT00658788|O1|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064182|NCT00658788|O4|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064183|NCT00658788|O3|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064184|NCT00658788|O2|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064185|NCT00658788|O1|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064186|NCT00658788|O4|Outcome|Week 12|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064187|NCT00658788|O3|Outcome|Week 8|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1073277|NCT00631748|E2|Reported Event|Placebo|Placebo (sugar pill)
1064188|NCT00658788|O2|Outcome|Week 4|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064189|NCT00658788|O1|Outcome|Week 2|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by 8 Weeks of Calcitriol Ointment, 3 µg/g Applied Once Daily
1064190|NCT00658788|O1|Outcome|Sequential Treatment Regimen|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
1064191|NCT00658788|E1|Reported Event|Sequential Treatment Regimen|4 weeks Clobex® Spray 0.05% Treatment Applied Topically Twice Daily Followed by Calcitriol Ointment, 3 µg/g Applied Once Daily
1064192|NCT00658775|B3|Baseline|Total|Total of all reporting groups
1064193|NCT00658775|B2|Baseline|RAB ER 50mg|Rabeprazole (RAB) Extended Release (ER) 50mg capsule concurrently with placebo (identical in appearance to the ESO 40mg capsule), once daily for 4 to 8 weeks.
1064194|NCT00658775|B1|Baseline|ESO 40mg|Esomeprazole (ESO) 40mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50mg capsule), once daily for 4 to 8 weeks.
1064195|NCT00658775|P2|Participant Flow|RAB ER 50mg|Rabeprazole (RAB) Extended Release (ER) 50mg capsule concurrently with placebo (identical in appearance to the ESO 40mg capsule), once daily for 4 to 8 weeks.
1064196|NCT00658775|P1|Participant Flow|ESO 40mg|Esomeprazole (ESO) 40mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50mg capsule), once daily for 4 to 8 weeks.
1064197|NCT00658775|O2|Outcome|RAB ER 50mg|Rabeprazole (RAB) Extended Release (ER) 50mg capsule concurrently with placebo (identical in appearance to the ESO 40mg capsule), once daily for 4 to 8 weeks.
1064198|NCT00658775|O1|Outcome|ESO 40mg|Esomeprazole (ESO) 40mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50mg capsule), once daily for 4 to 8 weeks.
1064199|NCT00658775|O2|Outcome|RAB ER 50mg|Rabeprazole (RAB) Extended Release (ER) 50mg capsule concurrently with placebo (identical in appearance to the ESO 40mg capsule), once daily for 4 to 8 weeks.
1064200|NCT00658775|O1|Outcome|ESO 40mg|Esomeprazole (ESO) 40mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50mg capsule), once daily for 4 to 8 weeks.
1064201|NCT00658775|O2|Outcome|RAB ER 50mg|Rabeprazole (RAB) Extended Release (ER) 50mg capsule concurrently with placebo (identical in appearance to the ESO 40mg capsule), once daily for 4 to 8 weeks.
1064202|NCT00658775|O1|Outcome|ESO 40mg|Esomeprazole (ESO) 40mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50mg capsule), once daily for 4 to 8 weeks.
1064203|NCT00658775|E2|Reported Event|RAB ER 50mg|Rabeprazole (RAB) Extended Release (ER) 50mg capsule concurrently with placebo (identical in appearance to the ESO 40mg capsule), once daily for 4 to 8 weeks.
1064204|NCT00658775|E1|Reported Event|ESO 40mg|Esomeprazole (ESO) 40mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50mg capsule), once daily for 4 to 8 weeks.
1064205|NCT00658736|B3|Baseline|Total|Total of all reporting groups
1064206|NCT00658736|B2|Baseline|Bupivicaine Alone|"EUS guided celiac block with bupivicaine only~Bupivicaine alone"
1064207|NCT00658736|B1|Baseline|Bupivicaine and Triamcinolone|"EUS guided celiac block with bupivicaine and triamcinolone~Triamcinolone"
1064208|NCT00658736|P2|Participant Flow|Bupivicaine Plus Triamcinolone|EUS-guided celiac plexus block administered with 20cc Bupivicaine 0.25% solution mixed with 80 mg Triamcinolone.
1064209|NCT00658736|P1|Participant Flow|Bupivicaine Alone|EUS-guided celiac plexus block administered with 20cc Bupivicaine 0.25% solution.
1064210|NCT00658736|O2|Outcome|Bupivicaine Alone|"EUS guided celiac block with bupivicaine only~Bupivicaine alone"
1064211|NCT00658736|O1|Outcome|Bupivicaine and Triamcinolone|"EUS guided celiac block with bupivicaine and triamcinolone~Triamcinolone"
1064212|NCT00658736|O2|Outcome|Bupivicaine Alone|"EUS guided celiac block with bupivicaine only~Bupivicaine alone"
1064213|NCT00658736|O1|Outcome|Bupivicaine and Triamcinolone|"EUS guided celiac block with bupivicaine and triamcinolone~Triamcinolone"
1064214|NCT00658736|E2|Reported Event|Bupivicaine Alone|"EUS guided celiac block with bupivicaine only~Bupivicaine alone"
1064215|NCT00658736|E1|Reported Event|Bupivicaine and Triamcinolone|"EUS guided celiac block with bupivicaine and triamcinolone~Triamcinolone"
1064216|NCT00658723|B3|Baseline|Total|Total of all reporting groups
1064217|NCT00658723|B2|Baseline|SURGICEL™ Randomized|SURGICEL™ Absorbable Hemostat
1064218|NCT00658723|B1|Baseline|Fibrin Pad All|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized & Non Randomized
1064219|NCT00658723|P3|Participant Flow|Fibrin Pad Non-randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). (Non - Randomized)
1064220|NCT00658723|P2|Participant Flow|SURGICEL™ Randomized|"SURGICEL™ Absorbable Hemostat~SURGICEL™: Absorbable hemostat"
1064221|NCT00658723|P1|Participant Flow|Fibrin Pad Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
1064222|NCT00658723|O2|Outcome|SURGICEL™ Randomized|SURGICEL™ Absorbable Hemostat
1064223|NCT00658723|O1|Outcome|Fibrin Pad All|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized & Non Randomized
1064224|NCT00658723|O3|Outcome|Fibrin Pad - Non-randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-randomized
1064225|NCT00658723|O2|Outcome|SURGICEL|SURGICEL™ Absorbable Hemostat
1064226|NCT00658723|O1|Outcome|Fibrin Pad - Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
1064629|NCT00657280|E1|Reported Event|Sitagliptin|There is only one group. All the participants took the Sitagliptin.
1064227|NCT00658723|O3|Outcome|Fibrin Pad - Non-randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-randomized
1064228|NCT00658723|O2|Outcome|SURGICEL|SURGICEL™ Absorbable Hemostat
1064229|NCT00658723|O1|Outcome|Fibrin Pad - Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
1064230|NCT00658723|O3|Outcome|Fibrin Pad - Non-randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-randomized
1064231|NCT00658723|O2|Outcome|SURGICEL|SURGICEL™ Absorbable Hemostat
1064232|NCT00658723|O1|Outcome|Fibrin Pad - Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
1064233|NCT00658723|O3|Outcome|Fibrin Pad - Non-randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-randomized
1064234|NCT00658723|O2|Outcome|SURGICEL|SURGICEL™ Absorbable Hemostat
1064235|NCT00658723|O1|Outcome|Fibrin Pad - Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
1064236|NCT00658723|O3|Outcome|Fibrin Pad - Non-randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-Randomized
1064237|NCT00658723|O2|Outcome|SURGICEL|SURGICEL™ Absorbable Hemostat
1064238|NCT00658723|O1|Outcome|Fibrin Pad - Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
1064239|NCT00658723|O3|Outcome|Fibrin Pad - Non-randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-Randomized
1064240|NCT00658723|O2|Outcome|SURGICEL|SURGICEL™ Absorbable Hemostat
1064241|NCT00658723|O1|Outcome|Fibrin Pad - Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
1064242|NCT00658723|O3|Outcome|Fibrin Pad - Non-Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Non-Randomized
1064243|NCT00658723|O2|Outcome|SURGICEL|SURGICEL™ Absorbable Hemostat
1064244|NCT00658723|O1|Outcome|Fibrin Pad - Randomized|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized
1064245|NCT00658723|E2|Reported Event|SURGICEL™ Randomized|SURGICEL™ Absorbable Hemostat
1064246|NCT00658723|E1|Reported Event|Fibrin Pad All|Fibrin Pad: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). - Randomized & Non Randomized
1064247|NCT00658697|B1|Baseline|Docetaxel, Bevacizumab, and Androgen Deprivation Therapy (ADT)|"Docetaxel:~Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab:~Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~Androgen deprivation therapy (ADT) or Luteinizing hormone-releasing hormone agonist (LHRH):~Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide:~Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)~Docetaxel~Bevacizumab: intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
1064248|NCT00658697|P1|Participant Flow|Docetaxel, Bevacizumab, and ADT|"Docetaxel:~Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab:~Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT or Luteinizing hormone-releasing hormone agonist (LHRH):~Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide:~Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)~Docetaxel~Bevacizumab: intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
1064249|NCT00658697|O1|Outcome|Docetaxel, Bevacizumab, and ADT|"Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT or Luteinizing hormone-releasing hormone agonist (LHRH): Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)~Docetaxel~Bevacizumab: ntravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
1064275|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
1064276|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
1064277|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
1064250|NCT00658697|O1|Outcome|Docetaxel, Bevacizumab, and ADT|"Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT or Luteinizing hormone-releasing hormone agonist (LHRH): Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide:~Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)~Docetaxel~Bevacizumab: intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
1064251|NCT00658697|O1|Outcome|Docetaxel, Bevacizumab, and ADT|"Docetaxel:~Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab:~Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT or Luteinizing hormone-releasing hormone agonist (LHRH):~Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide:~Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)~Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
1064252|NCT00658697|O1|Outcome|Docetaxel, Bevacizumab, and ADT|"Docetaxel:~Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab:~Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT or Luteinizing hormone-releasing hormone agonist (LHRH):~Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide:~Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)~Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
1064253|NCT00658697|O1|Outcome|Docetaxel, Bevacizumab, and ADT|"Docetaxel:~Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab:~Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT or Luteinizing hormone-releasing hormone agonist (LHRH):~Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide:~Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)~Docetaxel: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
1064254|NCT00658697|E1|Reported Event|Docetaxel, Bevacizumab, and ADT|"Docetaxel:~Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles~Bevacizumab:~Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT or Luteinizing hormone-releasing hormone agonist (LHRH):~Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide:~Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)~Docetaxel~Bevacizumab: ntravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles~ADT: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)~Bicalutamide: Starting on day 84 orally once daily until hormone therapy is completed"
1064255|NCT00658684|B4|Baseline|Total|Total of all reporting groups
1064256|NCT00658684|B3|Baseline|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
1064257|NCT00658684|B2|Baseline|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
1064258|NCT00658684|B1|Baseline|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
1064259|NCT00658684|P4|Participant Flow|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
1064260|NCT00658684|P3|Participant Flow|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
1064261|NCT00658684|P2|Participant Flow|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
1064262|NCT00658684|P1|Participant Flow|Total|All subjects
1064263|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
1064264|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
1064265|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
1064266|NCT00658684|O1|Outcome|Total|All subjects
1064267|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
1064268|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
1064269|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
1064270|NCT00658684|O1|Outcome|Total|All subjects
1064271|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
1064272|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
1064273|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
1064274|NCT00658684|O1|Outcome|Total|All subjects
1064279|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
1064280|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
1064281|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
1064282|NCT00658684|O1|Outcome|Total|All subjects
1064283|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
1064284|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
1064285|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
1064286|NCT00658684|O1|Outcome|Total|All subjects
1064287|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
1064288|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
1064289|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
1064290|NCT00658684|O1|Outcome|Total|All subjects
1064291|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
1064292|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
1064293|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
1064294|NCT00658684|O1|Outcome|Total|All subjects
1064295|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
1064296|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
1064297|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
1064298|NCT00658684|O1|Outcome|Total|All subjects
1064299|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
1064300|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
1064301|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
1064302|NCT00658684|O1|Outcome|Total|All subjects
1064303|NCT00658684|O4|Outcome|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
1064304|NCT00658684|O3|Outcome|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
1064305|NCT00658684|O2|Outcome|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
1064306|NCT00658684|O1|Outcome|Total|All subjects
1064307|NCT00658684|E4|Reported Event|4 mg > 8 mg|Increased to fesoterodine 8 mg at Week 4 and remained on a dose of 8 mg after Week 4 (subjects whose dose was increased to 8 mg and maintained)
1064308|NCT00658684|E3|Reported Event|4 mg > 8 mg > 4 mg|Increased to fesoterodine 8 mg at Week 4 and reduced to 4 mg at Week 8 (subjects whose dose was increased to 8 mg and then reduced to 4 mg)
1064309|NCT00658684|E2|Reported Event|4 mg|Remained on a dose of fesoterodine 4 mg for the entire treatment period (subjects who remained on a dose of 4 mg)
1064310|NCT00658684|E1|Reported Event|Total|All subjects
1064311|NCT00658658|B6|Baseline|Total|Total of all reporting groups
1064312|NCT00658658|B5|Baseline|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064313|NCT00658658|B4|Baseline|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064314|NCT00658658|B3|Baseline|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064315|NCT00658658|B2|Baseline|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064316|NCT00658658|B1|Baseline|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064317|NCT00658658|P5|Participant Flow|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064392|NCT00658619|B4|Baseline|200 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
1073278|NCT00631748|E1|Reported Event|Study Drug|Oral quetiapine
1064318|NCT00658658|P4|Participant Flow|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064319|NCT00658658|P3|Participant Flow|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064320|NCT00658658|P2|Participant Flow|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064321|NCT00658658|P1|Participant Flow|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064322|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064323|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064324|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064325|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064326|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064327|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064328|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064329|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064330|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064331|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064332|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064333|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064334|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064335|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064336|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064337|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064338|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064339|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064393|NCT00658619|B3|Baseline|400 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
1064340|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064341|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064342|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064343|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064344|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064345|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064346|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064347|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064348|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064349|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064350|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064351|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064352|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064353|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064354|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064355|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064356|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064357|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064358|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064359|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064360|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064361|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064394|NCT00658619|B2|Baseline|200 µg Brimonidine Tartrate Implant Stage 1|Stage 1: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
1064362|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064363|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064364|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064365|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064366|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064367|NCT00658658|O5|Outcome|Age 1–11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064368|NCT00658658|O4|Outcome|Age 1–11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064369|NCT00658658|O3|Outcome|Age 12–17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064370|NCT00658658|O2|Outcome|Age 12–17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064371|NCT00658658|O1|Outcome|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064372|NCT00658658|E5|Reported Event|Age 1-11: 6 mg/kg Q2W|Participants aged 1 to 11 years received panitumumab 6 mg/kg administered by IV infusion Q2W until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064373|NCT00658658|E4|Reported Event|Age 1-11: 2.5 mg/kg QW|Participants aged 1 to 11 years received panitumumab 2.5 mg/kg administered by IV infusion QW until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064374|NCT00658658|E3|Reported Event|Age 12-17: 9 mg/kg Q3W|Participants aged 12 to 17 years received panitumumab 9 mg/kg administered by IV infusion every 3 weeks (Q3W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064375|NCT00658658|E2|Reported Event|Age 12-17: 6 mg/kg Q2W|Participants aged 12 to 17 years received panitumumab 6 mg/kg administered by IV infusion every 2 weeks (Q2W) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064376|NCT00658658|E1|Reported Event|Age 12–17: 2.5 mg/kg QW|Participants aged 12 to 17 years received panitumumab 2.5 mg/kg administered by intravenous (IV) infusion weekly (QW) until the participant experienced disease progression, was unable to tolerate study drug, withdrew consent, or other reasons that warranted removal from the study.
1064377|NCT00658632|B3|Baseline|Total|Total of all reporting groups
1064378|NCT00658632|B2|Baseline|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
1064379|NCT00658632|B1|Baseline|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
1064380|NCT00658632|P2|Participant Flow|Rabeprazole (RAB) Extended Release (ER) 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
1064381|NCT00658632|P1|Participant Flow|Esomeprazole (ESO) 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
1064382|NCT00658632|O2|Outcome|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
1064383|NCT00658632|O1|Outcome|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
1064384|NCT00658632|O2|Outcome|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
1064385|NCT00658632|O1|Outcome|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
1064386|NCT00658632|O2|Outcome|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
1064387|NCT00658632|O1|Outcome|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
1064388|NCT00658632|E2|Reported Event|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
1064389|NCT00658632|E1|Reported Event|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
1064390|NCT00658619|B6|Baseline|Total|Total of all reporting groups
1064395|NCT00658619|B1|Baseline|400 µg Brimonidine Tartrate Implant Stage 1|Stage 1: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
1064396|NCT00658619|P5|Participant Flow|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
1064397|NCT00658619|P4|Participant Flow|200 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
1064398|NCT00658619|P3|Participant Flow|400 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
1064399|NCT00658619|P2|Participant Flow|200 µg Brimonidine Tartrate Implant Stage 1|Stage 1: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
1064400|NCT00658619|P1|Participant Flow|400 µg Brimonidine Tartrate Implant Stage 1|Stage 1: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
1064401|NCT00658619|O3|Outcome|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
1064402|NCT00658619|O2|Outcome|200 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 200 µg brimonidine tartrate implant in study eye and sham in fellow eye on Day 1 and Month 6.
1064403|NCT00658619|O1|Outcome|400 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
1064404|NCT00658619|O3|Outcome|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
1064405|NCT00658619|O2|Outcome|200 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 200 µg brimonidine tartrate implant in study eye and sham in fellow eye on Day 1 and Month 6.
1064406|NCT00658619|O1|Outcome|400 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
1064407|NCT00658619|O3|Outcome|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
1064408|NCT00658619|O2|Outcome|200 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 200 µg brimonidine tartrate implant in study eye and sham in fellow eye on Day 1 and Month 6.
1064409|NCT00658619|O1|Outcome|400 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
1064410|NCT00658619|O3|Outcome|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
1064411|NCT00658619|O2|Outcome|200 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 200 µg brimonidine tartrate implant in study eye and sham in fellow eye on Day 1 and Month 6.
1064412|NCT00658619|O1|Outcome|400 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
1064413|NCT00658619|O3|Outcome|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
1064414|NCT00658619|O2|Outcome|200 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
1064415|NCT00658619|O1|Outcome|400 µg Brimonidine Tartrate Implant Stage 2|Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
1064416|NCT00658619|E3|Reported Event|Sham (no Implant) Stage 2|Stage 2: sham in both eyes on Day 1 and Month 6.
1064417|NCT00658619|E2|Reported Event|200 µg Brimonidine Tartrate Implant|Stage 1 and 2 combined: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
1064418|NCT00658619|E1|Reported Event|400 µg Brimonidine Tartrate Implant|Stage 1 and 2 combined: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
1064419|NCT00658606|B3|Baseline|Total|Total of all reporting groups
1064420|NCT00658606|B2|Baseline|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
1064421|NCT00658606|B1|Baseline|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
1064422|NCT00658606|P2|Participant Flow|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
1064423|NCT00658606|P1|Participant Flow|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
1064424|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
1064425|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
1064426|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
1064427|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
1064428|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
1064429|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
1064430|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
1064431|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
1064432|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
1064433|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
1064434|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
1064435|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
1064436|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
1064437|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
1064438|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
1064439|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
1064440|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
1064441|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
1064442|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
1064443|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
1064444|NCT00658606|O2|Outcome|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
1064445|NCT00658606|O1|Outcome|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
1064446|NCT00658606|E2|Reported Event|Alefacept + nbUVB|15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
1064447|NCT00658606|E1|Reported Event|Alefacept Alone|15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
1064448|NCT00658567|B4|Baseline|Total|Total of all reporting groups
1064449|NCT00658567|B3|Baseline|20 mg|Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
1064450|NCT00658567|B2|Baseline|10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
1064451|NCT00658567|B1|Baseline|Placebo|Placebo tablet, once daily by mouth, 6 weeks
1064452|NCT00658567|P3|Participant Flow|Pimavanserin 20 mg|Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
1064453|NCT00658567|P2|Participant Flow|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
1064454|NCT00658567|P1|Participant Flow|Placebo|Placebo tablet, once daily by mouth, 6 weeks
1064455|NCT00658567|O3|Outcome|Pimavanserin 20 mg|Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
1064456|NCT00658567|O2|Outcome|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
1064457|NCT00658567|O1|Outcome|Placebo|Placebo tablet, once daily by mouth, 6 weeks
1064458|NCT00658567|O3|Outcome|Pimavanserin 20 mg|Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
1064459|NCT00658567|O2|Outcome|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
1064460|NCT00658567|O1|Outcome|Placebo|Placebo tablet, once daily by mouth, 6 weeks
1064461|NCT00658567|E3|Reported Event|Pimavanserin 20 mg|Pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
1064462|NCT00658567|E2|Reported Event|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
1064463|NCT00658567|E1|Reported Event|Placebo|Placebo tablet, once daily by mouth, 6 weeks
1064464|NCT00658541|B1|Baseline|Zolpidem Tartrate 10 mg Tablets and Ambien® 10 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast of at least 10 hours and a standardized, high fat breakfast.
1064465|NCT00658541|P2|Participant Flow|Ambien® 10 mg Tablets Then Zolpidem Tartrate 10 mg Tablets|On the morning of Day 1 following an overnight fast of at least 10 hours and a standardized, high fat breakfast, each subject received one tablet of the reference formulation, Ambien® 10 mg, followed by a 7 day washout period. Then, on the morning of Day 8 following an overnight fast of at least 10 hours and a standardized, high fat breakfast, each subject received a single tablet of the test formulation, zolpidem tartrate 10 mg.
1064466|NCT00658541|P1|Participant Flow|Zolpidem Tartrate 10 mg Tablets Then Ambien® 10 mg Tablets|On the morning of Day 1 following an an overnight fast of at least 10 hours and a standardized, high-fat breakfast, each subject received one tablet of the test formulation, zolpidem tartrate 10 mg, followed by a 7 day washout period. Then, on the morning of Day 8 following an overnight fast of at least 10 hours and a standardized, high-fat breakfast, each subject received a single tablet of the reference formulation, Ambien® 10 mg.
1064467|NCT00658541|O2|Outcome|Ambien® 10 mg Tablets|Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours and a standardized, high fat breakfast.
1064468|NCT00658541|O1|Outcome|Zolpidem Tartrate 10 mg Tablets|Each subject received one tablet of zolpidem tartrate 10 mg after an overnight fast of at least 10 hours and a standardized, high fast breakfast.
1064469|NCT00658541|O2|Outcome|Ambien® 10 mg Tablets|Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours and a standardized, high fat breakfast.
1064470|NCT00658541|O1|Outcome|Zolpidem Tartrate 10 mg Tablets|Each subject received one tablet of zolpidem tartrate 10 mg after an overnight fast of at least 10 hours and a standardized, high fast breakfast.
1064471|NCT00658541|O2|Outcome|Ambien® 10 mg Tablets|Each subject received one tablet of Ambien® 10 mg after an overnight fast of at least 10 hours and a standardized, high fat breakfast.
1064472|NCT00658541|O1|Outcome|Zolpidem Tartrate 10 mg Tablets|Each subject received one tablet of zolpidem tartrate 10 mg after an overnight fast of at least 10 hours and a standardized, high fast breakfast.
1064473|NCT00658541|E2|Reported Event|Ambien® 10 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast and a standardized, high fat breakfast.
1064474|NCT00658541|E1|Reported Event|Zolpidem Tartrate 10 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either zolpidem tartrate 10 mg or Ambien® 10 mg following an overnight fast and a standardized, high fat breakfast.
1064475|NCT00658528|B3|Baseline|Total|Total of all reporting groups
1064476|NCT00658528|B2|Baseline|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
1064477|NCT00658528|B1|Baseline|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
1064478|NCT00658528|P2|Participant Flow|RAB ER 50 mg|Rabeprazole (RAB) Extended Release (ER) 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
1064479|NCT00658528|P1|Participant Flow|ESO 40 mg|Esomeprazole (ESO) 40 mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50 mg capsule), once daily for 4 to 8 weeks.
1064480|NCT00658528|O2|Outcome|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
1064481|NCT00658528|O1|Outcome|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
1064482|NCT00658528|O2|Outcome|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
1064483|NCT00658528|O1|Outcome|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
1064484|NCT00658528|O2|Outcome|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
1064485|NCT00658528|O1|Outcome|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
1064486|NCT00658528|E2|Reported Event|RAB ER 50 mg|RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
1064487|NCT00658528|E1|Reported Event|ESO 40 mg|ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
1064488|NCT00658411|B1|Baseline|All Patients|Deferoxamine prior to stem cells
1064489|NCT00658411|P1|Participant Flow|All Patients|Deferoxamine for >= 2 weeks prior to stem cells
1064490|NCT00658411|O4|Outcome|Overall Survival (Deferoxamine)|Patients who received Deferoxamine and have relapsed and is alive at 1 year.
1064491|NCT00658411|O3|Outcome|Disease-Free Survival (Deferoxamine)|Patients who received Deferoxamine and are currently alive without incidence of relapse at 1 year.
1064492|NCT00658411|O2|Outcome|Relapse (Deferoxamine)|Patients who received Deferoxamine and relapsed post transplant at 1 year.
1064493|NCT00658411|O1|Outcome|Transplant-Related Mortality (Deferoxamine)|Patients who received Deferoxamine and passed away as a result of transplant or study treatment without prior relapse at 1 year.
1064494|NCT00658411|O1|Outcome|Deferoxamine|All patients received a maximum dose of 50mg/kg/d of deferoxamine as chelation therapy for at least 2 weeks prior to receiving myeloablative transplant.
1064495|NCT00658411|E1|Reported Event|Deferoxamine|All patients received a maximum dose of 50mg/kg/d of deferoxamine as chelation therapy for at least 2 weeks prior to receiving myeloablative transplant.
1064496|NCT00658385|B1|Baseline|GCSF, Neupogen, Filgrastim, Central Venous Line Placement, SCT|"GCSF (human recombinant granulocyte colony stimulating factor)Neupogen(Amgen), Filgrastim, Central venous line placement, Stem cell Collection (leukapheresis)~GCSF, Central venous line placement, Stem cell Collection (leukapheresis): Daily injections under the skin of a GCSF. This is done for 5 to 6 days. On days 1, 3,5, and if need on day 6. To collect stem cells, we need good access to this blood. If the patient has good veins, we do this by placing an IV on each one of their arms. The peripheral blood stem cell collection is usually an outpatient procedure and takes about 3 to 4 hours. You will have blood work and a physical exam on days one, three, and five while you are getting GCSF.~These will be done again 24 hours after your stem cells are collected."
1064497|NCT00658385|P1|Participant Flow|GCSF, Neupogen, Filgrastim, Central Venous Line Placement, SCT|"GCSF (human recombinant granulocyte colony stimulating factor)Neupogen(Amgen), Filgrastim, Central venous line placement, Stem cell Collection (leukapheresis)~GCSF, Central venous line placement, Stem cell Collection (leukapheresis): Daily injections under the skin of a GCSF. This is done for 5 to 6 days. On days 1, 3,5, and if need on day 6. To collect stem cells, we need good access to this blood. If the patient has good veins, we do this by placing an IV on each one of their arms. The peripheral blood stem cell collection is usually an outpatient procedure and takes about 3 to 4 hours. You will have blood work and a physical exam on days one, three, and five while you are getting GCSF.~These will be done again 24 hours after your stem cells are collected."
1064498|NCT00658385|O1|Outcome|GCSF, Neupogen, Filgrastim, Central Venous Line Placement, SCT|"GCSF (human recombinant granulocyte colony stimulating factor)Neupogen(Amgen), Filgrastim, Central venous line placement, Stem cell Collection (leukapheresis)~GCSF, Central venous line placement, Stem cell Collection (leukapheresis): Daily injections under the skin of a GCSF. This is done for 5 to 6 days. On days 1, 3,5, and if need on day 6. To collect stem cells, we need good access to this blood. If the patient has good veins, we do this by placing an IV on each one of their arms. The peripheral blood stem cell collection is usually an outpatient procedure and takes about 3 to 4 hours. You will have blood work and a physical exam on days one, three, and five while you are getting GCSF.~These will be done again 24 hours after your stem cells are collected."
1064499|NCT00658385|E1|Reported Event|GCSF, Neupogen, Filgrastim, Central Venous Line Placement, SCT|"GCSF (human recombinant granulocyte colony stimulating factor)Neupogen(Amgen), Filgrastim, Central venous line placement, Stem cell Collection (leukapheresis)~GCSF, Central venous line placement, Stem cell Collection (leukapheresis): Daily injections under the skin of a GCSF. This is done for 5 to 6 days. On days 1, 3,5, and if need on day 6. To collect stem cells, we need good access to this blood. If the patient has good veins, we do this by placing an IV on each one of their arms. The peripheral blood stem cell collection is usually an outpatient procedure and takes about 3 to 4 hours. You will have blood work and a physical exam on days one, three, and five while you are getting GCSF.~These will be done again 24 hours after your stem cells are collected."
1064500|NCT00658333|B3|Baseline|Total|Total of all reporting groups
1064501|NCT00658333|B2|Baseline|Mycophenolate Mofetil|Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
1064502|NCT00658333|B1|Baseline|Enteric-coated Mycophenolate Acid|Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
1064503|NCT00658333|P2|Participant Flow|Mycophenolate Mofetil|Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
1064758|NCT00656851|P2|Participant Flow|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
1064504|NCT00658333|P1|Participant Flow|Enteric-coated Mycophenolate Acid|Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
1064505|NCT00658333|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
1064506|NCT00658333|O1|Outcome|Enteric-coated Mycophenolate Acid|Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
1064507|NCT00658333|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
1064508|NCT00658333|O1|Outcome|Enteric-coated Mycophenolate Acid|Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
1064509|NCT00658333|E2|Reported Event|Mycophenolate Mofetil|Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
1064510|NCT00658333|E1|Reported Event|Enteric-coated Mycophenolate Acid|Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
1064511|NCT00658320|B3|Baseline|Total|Total of all reporting groups
1064512|NCT00658320|B2|Baseline|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
1064513|NCT00658320|B1|Baseline|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.75 mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8ng/mL).Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
1064514|NCT00658320|P2|Participant Flow|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
1064515|NCT00658320|P1|Participant Flow|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.75 mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
1064516|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 2 0mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
1064517|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.7 5mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
1064518|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 2 0mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
1064529|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
1064759|NCT00656851|P1|Participant Flow|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
1064519|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.7 5mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
1064520|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.7 5mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
1064521|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 2 0mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
1064522|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.7 5mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
1064523|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 2 0mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
1064524|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.7 5mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
1064525|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 2 0mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
1064526|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.7 5mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
1064527|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 2 0mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
1064528|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.7 5mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
1064582|NCT00657709|O4|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
1064583|NCT00657709|O3|Outcome|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
1064530|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.75 mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8ng/mL).Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
1064531|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
1064532|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.75 mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8ng/mL).Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
1064533|NCT00658320|O2|Outcome|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
1064534|NCT00658320|O1|Outcome|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.75 mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8ng/mL).Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
1064535|NCT00658320|E2|Reported Event|Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine|Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study.
1064536|NCT00658320|E1|Reported Event|Everolimus + Reduced Dose of Cyclosporine|An initial everolimus dose of 0.75 mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use.
1064537|NCT00658138|B1|Baseline|3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT|67 teeth in 61 subjects had 3M ESPE Adper Scotchbond SE 67 teeth in 61 subjects had 3M ESPE Adper Scotchbond 1XT
1064538|NCT00658138|P1|Participant Flow|3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT|67 teeth in 61 subjects had 3M ESPE Adper Scotchbond SE 67 teeth in 61 subjects had 3M ESPE Adper Scotchbond 1XT
1064539|NCT00658138|O2|Outcome|Scotchbond 1XT|3M ESPE Adper Scotchbond 1XT
1064540|NCT00658138|O1|Outcome|Scotchbond SE|3M ESPE Adper Scotchbond SE
1064541|NCT00658138|E1|Reported Event|3M ESPE Adper Scotchbond SE and 3M ESPE Adper Scotchbond 1XT|67 teeth in 61 subjects had 3M ESPE Adper Scotchbond SE 67 teeth in 61 subjects had 3M ESPE Adper Scotchbond 1XT
1064542|NCT00658112|B1|Baseline|Benzoyl Peroxide 5%|"Subjects will be given standard instructions in the use of topical benzoyl peroxide gel and will be provided with a supply of medication fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened which can be downloaded at the final visit and tabulated with associated software. When the tubes are weighed, data from the MEMS Caps will be collected. Study coordinators will record adherence, while assessors are blinded to adherence rates. All subjects will be assigned to treatment with topical benzoyl peroxide to the entire face.~Benzoyl Peroxide: Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks."
1064543|NCT00658112|P1|Participant Flow|Benzoyl Peroxide 5%|"Subjects will be given standard instructions in the use of topical benzoyl peroxide gel and will be provided with a supply of medication fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened which can be downloaded at the final visit and tabulated with associated software. When the tubes are weighed, data from the MEMS Caps will be collected. Study coordinators will record adherence, while assessors are blinded to adherence rates. All subjects will be assigned to treatment with topical benzoyl peroxide to the entire face.~Benzoyl Peroxide: Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks."
1064544|NCT00658112|O1|Outcome|Benzoyl Peroxide 5%|"Subjects will be given standard instructions in the use of topical benzoyl peroxide gel and will be provided with a supply of medication fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened which can be downloaded at the final visit and tabulated with associated software. When the tubes are weighed, data from the MEMS Caps will be collected. Study coordinators will record adherence, while assessors are blinded to adherence rates. All subjects will be assigned to treatment with topical benzoyl peroxide to the entire face.~Benzoyl Peroxide: Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks."
1073279|NCT00631696|B3|Baseline|Total|Total of all reporting groups
1064545|NCT00658112|E1|Reported Event|Benzoyl Peroxide 5%|"Subjects will be given standard instructions in the use of topical benzoyl peroxide gel and will be provided with a supply of medication fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened which can be downloaded at the final visit and tabulated with associated software. When the tubes are weighed, data from the MEMS Caps will be collected. Study coordinators will record adherence, while assessors are blinded to adherence rates. All subjects will be assigned to treatment with topical benzoyl peroxide to the entire face.~Benzoyl Peroxide: Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks."
1064546|NCT00657709|B6|Baseline|Total|Total of all reporting groups
1064547|NCT00657709|B5|Baseline|MenC+ Routine|Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age.
1064548|NCT00657709|B4|Baseline|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
1064549|NCT00657709|B3|Baseline|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
1064550|NCT00657709|B2|Baseline|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
1064551|NCT00657709|B1|Baseline|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
1064552|NCT00657709|P5|Participant Flow|MenC+ Routine|Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age.
1064553|NCT00657709|P4|Participant Flow|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
1064554|NCT00657709|P3|Participant Flow|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
1064555|NCT00657709|P2|Participant Flow|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
1064556|NCT00657709|P1|Participant Flow|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
1064557|NCT00657709|O2|Outcome|MenC+Routine|Subjects received the routinely administered infant vaccines and MenC vaccine at 2, 4 and 6 months of age.
1064558|NCT00657709|O1|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot 2, or Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
1064559|NCT00657709|O5|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
1064560|NCT00657709|O4|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot 2, or Lot 3)at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
1064561|NCT00657709|O3|Outcome|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
1064562|NCT00657709|O2|Outcome|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ(Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
1064563|NCT00657709|O1|Outcome|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
1064564|NCT00657709|O5|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
1064565|NCT00657709|O4|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot2, or Lot3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
1064566|NCT00657709|O3|Outcome|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ(Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
1064567|NCT00657709|O2|Outcome|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
1064568|NCT00657709|O1|Outcome|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ(Lot1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
1064569|NCT00657709|O2|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
1064570|NCT00657709|O1|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot 2, or Lot 3)at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
1064571|NCT00657709|O2|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
1064572|NCT00657709|O1|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot 2, or Lot 3)at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
1064573|NCT00657709|O2|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
1064574|NCT00657709|O1|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot 2, or Lot 3)at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
1064575|NCT00657709|O5|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
1064576|NCT00657709|O4|Outcome|rMenB All|Subjects received one injection fo rMenB+OMV NZ (Lot1, or Lot 2, or Lot 3) at 2, 4, and 6months of age concomitantly with the routinely administered infant vaccines.
1064577|NCT00657709|O3|Outcome|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
1064578|NCT00657709|O2|Outcome|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
1064579|NCT00657709|O1|Outcome|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
1064580|NCT00657709|O2|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
1064581|NCT00657709|O1|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot 2, or Lot 3)at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
1064584|NCT00657709|O2|Outcome|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
1064585|NCT00657709|O1|Outcome|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
1064586|NCT00657709|O2|Outcome|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
1064587|NCT00657709|O1|Outcome|rMenB All|Subjects received one injection of rMenB+OMV NZ (Lot 1, or Lot 2, or Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
1064588|NCT00657709|O3|Outcome|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
1064589|NCT00657709|O2|Outcome|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
1064590|NCT00657709|O1|Outcome|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
1064591|NCT00657709|E5|Reported Event|MenC+Routine|Subjects received the routinely administered infant vaccines and MenC vaccine at 2, 4 and 6 months of age.
1064592|NCT00657709|E4|Reported Event|Routine|Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
1064593|NCT00657709|E3|Reported Event|rMenB Lot3|Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
1064594|NCT00657709|E2|Reported Event|rMenB Lot2|Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
1064595|NCT00657709|E1|Reported Event|rMenB Lot1|Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
1064596|NCT00657657|B1|Baseline|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
1064597|NCT00657657|P1|Participant Flow|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
1064598|NCT00657657|O1|Outcome|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
1064599|NCT00657657|O1|Outcome|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
1064600|NCT00657657|O1|Outcome|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
1064601|NCT00657657|O1|Outcome|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
1064602|NCT00657657|O1|Outcome|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
1064603|NCT00657657|E1|Reported Event|Engerix Group|Subjects received a challenge dose of hepatitis B vaccine (Engerix™-B).
1064604|NCT00657553|B3|Baseline|Total|Total of all reporting groups
1064605|NCT00657553|B2|Baseline|Observation Arm|Patients will be observed for progress over the course of three years.
1064606|NCT00657553|B1|Baseline|Treatment Arm|Bortezomib will be administered as 12 monthly courses of 1.0 mg/m2 on days 1, 4, 8, and 11 and repeated every 28 days, followed by cycles administered every other month in year 2, and then every 3 months in year 3
1064607|NCT00657553|P2|Participant Flow|Observation Arm|Patients will be observed for progress over the course of three years.
1064608|NCT00657553|P1|Participant Flow|Treatment Arm|Bortezomib will be administered as 12 monthly courses of 1.0 mg/m2 on days 1, 4, 8, and 11 and repeated every 28 days, followed by cycles administered every other month in year 2, and then every 3 months in year 3
1064609|NCT00657553|O2|Outcome|Observation Arm|Patients will be observed for progress over the course of three years.
1064610|NCT00657553|O1|Outcome|Treatment Arm|Bortezomib will be administered as 12 monthly courses of 1.0 mg/m2 on days 1, 4, 8, and 11 and repeated every 28 days, followed by cycles administered every other month in year 2, and then every 3 months in year 3
1064611|NCT00657553|E2|Reported Event|Observation Arm|Patients will be observed for progress over the course of three years.
1064612|NCT00657553|E1|Reported Event|Treatment Arm|Bortezomib will be administered as 12 monthly courses of 1.0 mg/m2 on days 1, 4, 8, and 11 and repeated every 28 days, followed by cycles administered every other month in year 2, and then every 3 months in year 3
1064613|NCT00657371|B1|Baseline|Third Eye Retroscope|Colonoscopy exam using the Third Eye Retroscope device
1064614|NCT00657371|P1|Participant Flow|Third Eye Retroscope|Colonoscopy exam using the Third Eye Retroscope device
1064615|NCT00657371|O1|Outcome|Third Eye Retroscope|Colonoscopy exam using the Third Eye Retroscope device
1064616|NCT00657371|O1|Outcome|Third Eye Retroscope|Colonoscopy exam using the Third Eye Retroscope device
1064617|NCT00657371|E1|Reported Event|Third Eye Retroscope|Colonoscopy exam using the Third Eye Retroscope device
1064618|NCT00657358|B1|Baseline|Lidocaine|Healthy Volunteers receiving Lidocaine
1064619|NCT00657358|P1|Participant Flow|Lidocaine|Healthy Volunteers receiving Lidocaine
1064620|NCT00657358|O1|Outcome|Lidocaine Administration|Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.
1064621|NCT00657358|O1|Outcome|Lidocaine Administration|Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.
1064622|NCT00657358|O1|Outcome|Lidocaine Administration|Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.
1064623|NCT00657358|O1|Outcome|Lidocaine Administration|Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.infused within 20 minutes.
1064624|NCT00657358|O1|Outcome|Lidocaine Administration|Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.
1064625|NCT00657358|E1|Reported Event|Lidocaine|Healthy Volunteers receiving Lidocaine
1064626|NCT00657280|B1|Baseline|Sitagliptin|There is only one group. All the participants took the Sitagliptin.
1064627|NCT00657280|P1|Participant Flow|Sitagliptin|There is only one group. All the participants took Sitagliptin 100mg daily and acted as their own controls
1064630|NCT00657267|B1|Baseline|12 Cycles of Dose-Dense Temozolomide (Single Arm Study)|Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets)
1064631|NCT00657267|P1|Participant Flow|12 Cycles of Dose-Dense Temozolomide (Single Arm Study)|Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets)
1064632|NCT00657267|O1|Outcome|12 Cycles of Dose-Dense Temozolomide (Single Arm Study)|Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets)
1064633|NCT00657267|O2|Outcome|Complete Response|Complete responders on study; Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets)
1064634|NCT00657267|O1|Outcome|Partial Response|Partial Responders on study; Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets)
1064635|NCT00657267|O1|Outcome|12 Cycles of Dose-Dense Temozolomide (Single Arm Study)|Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets)
1064636|NCT00657267|O1|Outcome|12 Cycles of Dose-Dense Temozolomide (Single Arm Study)|Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets)
1064637|NCT00657267|E1|Reported Event|12 Cycles of Dose-Dense Temozolomide (Single Arm Study)|All 58 participants who started treatment: Temozolomide dose = 100 mg/m2/day for 21 days of every 28-day cycle (75 mg/m2/day for 21 days of every 28-day cycle if pt experienced myelosuppression on prior regimen: gr 1 ANC &/or gr 2 platelets
1064638|NCT00657150|B3|Baseline|Total|Total of all reporting groups
1064639|NCT00657150|B2|Baseline|Enoxaparin|40mg qd (once daily) subcutaneous
1064640|NCT00657150|B1|Baseline|Dabigatran 220mg|qd (once daily) oral
1064641|NCT00657150|P2|Participant Flow|Enoxaparin|40mg qd (once daily) subcutaneous
1064642|NCT00657150|P1|Participant Flow|Dabigatran 220mg|qd (once daily) oral
1064643|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
1064644|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
1064645|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
1064646|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
1064647|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
1064648|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
1064649|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
1064650|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
1064651|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
1064652|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
1064653|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
1064654|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
1064655|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
1064656|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
1064657|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
1064658|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
1064659|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
1064660|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
1064661|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
1064662|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
1064663|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
1064664|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
1064665|NCT00657150|O2|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
1064666|NCT00657150|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
1064667|NCT00657150|E2|Reported Event|Enoxaparin|40mg qd (once daily) subcutaneous
1064668|NCT00657150|E1|Reported Event|Dabigatran 220mg|qd (once daily) oral
1064669|NCT00657046|B4|Baseline|Total|Total of all reporting groups
1064670|NCT00657046|B3|Baseline|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064671|NCT00657046|B2|Baseline|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064672|NCT00657046|B1|Baseline|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064673|NCT00657046|P3|Participant Flow|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064674|NCT00657046|P2|Participant Flow|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064675|NCT00657046|P1|Participant Flow|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064676|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064677|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064760|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
1064678|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064679|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064680|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064681|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064682|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064683|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064684|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064685|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064686|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064687|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064688|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064689|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064690|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064691|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064692|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064693|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064694|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064695|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064696|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064697|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064698|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064699|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064700|NCT00657046|O3|Outcome|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064701|NCT00657046|O2|Outcome|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064702|NCT00657046|O1|Outcome|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064703|NCT00657046|E3|Reported Event|Placebo|Placebo (3 capsules with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064704|NCT00657046|E2|Reported Event|Droxidopa 600mg|Droxidopa at 600 mg (3 capsules each containing 200 mg droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064705|NCT00657046|E1|Reported Event|Droxidopa 400mg|Droxidopa at 400 mg (2 capsules each containing 200 mg droxidopa plus one capsule with mannitol substituted for droxidopa) taken 1 hour (+/-15 minutes) prior to each hemodialysis session. Study treatments were administered over 4 weeks.
1064706|NCT00657020|B1|Baseline|All Randomized Participants|All randomized participants who receive study treatments.
1064707|NCT00657020|P2|Participant Flow|Placebo Lozenge Then 4 mg Nicotine Lozenge|Participants received placebo lozenge in Period I and nicotine 4 mg lozenge in Period II.
1064708|NCT00657020|P1|Participant Flow|4 mg Nicotine Lozenge Then Placebo Lozenge|Participants received nicotine lozenge containing 4 milligrams (mg) of nicotine in Period I and placebo lozenge in Period II.
1064709|NCT00657020|O4|Outcome|Placebo Lozenge 2|Participants in high attention conditions and received placebo lozenge.
1064710|NCT00657020|O3|Outcome|Nicotine Lozenge 2|Participants in high attention conditions and received 4 mg of nicotine lozenge.
1064711|NCT00657020|O2|Outcome|Placebo Lozenge 1|Participants in low attention conditions and received placebo lozenge.
1064712|NCT00657020|O1|Outcome|Nicotine Lozenge 1|Participants in low attention conditions and received 4 mg of nicotine lozenge.
1064713|NCT00657020|O4|Outcome|Placebo Lozenge 2|Participants in high attention conditions and received placebo lozenge.
1064714|NCT00657020|O3|Outcome|Nicotine Lozenge 2|Participants in high attention conditions and received 4 mg of nicotine lozenge.
1064715|NCT00657020|O2|Outcome|Placebo Lozenge 1|Participants in low attention conditions and received placebo lozenge.
1064716|NCT00657020|O1|Outcome|Nicotine Lozenge 1|Participants in low attention conditions and received 4 mg of nicotine lozenge.
1064717|NCT00657020|O4|Outcome|Placebo Lozenge 2|Participants in high attention conditions and received placebo lozenge.
1064718|NCT00657020|O3|Outcome|Nicotine Lozenge 2|Participants in high attention conditions and received 4 mg of nicotine lozenge.
1064719|NCT00657020|O2|Outcome|Placebo Lozenge 1|Participants in low attention conditions and received placebo lozenge.
1064720|NCT00657020|O1|Outcome|Nicotine Lozenge 1|Participants in low attention conditions and received 4 mg of nicotine lozenge.
1064721|NCT00657020|O4|Outcome|Placebo Lozenge 2|Participants in high attention conditions and received placebo lozenge.
1064722|NCT00657020|O3|Outcome|Nicotine Lozenge 2|Participants in high attention conditions and received 4 mg of nicotine lozenge.
1064723|NCT00657020|O2|Outcome|Placebo Lozenge 1|Participants in low attention conditions and received placebo lozenge.
1064724|NCT00657020|O1|Outcome|Nicotine Lozenge 1|Participants in low attention conditions and received 4 mg of nicotine lozenge.
1064725|NCT00657020|O4|Outcome|Placebo Lozenge 2|Participants in high attention condition and received placebo lozenge.
1064726|NCT00657020|O3|Outcome|Nicotine Lozenge 2|Participants in high attention condition and received 4 mg of nicotine lozenge.
1064727|NCT00657020|O2|Outcome|Placebo Lozenge 1|Participants in low attention condition and received placebo lozenge.
1064728|NCT00657020|O1|Outcome|Nicotine Lozenge 1|Participants in low attention condition and received 4 mg of nicotine lozenge.
1064729|NCT00657020|O4|Outcome|Placebo Lozenge 2|Participants in high attention condition and received placebo lozenge.
1064730|NCT00657020|O3|Outcome|Nicotine Lozenge 2|Participants in high attention condition and received 4 mg of nicotine lozenge.
1064731|NCT00657020|O2|Outcome|Placebo Lozenge 1|Participants in low attention condition and received placebo lozenge.
1064732|NCT00657020|O1|Outcome|Nicotine Lozenge 1|Participants in low attention condition and received 4 mg of nicotine lozenge.
1064733|NCT00657020|E2|Reported Event|Placebo Lozenge|Participants in safety population received placebo lozenge.
1064734|NCT00657020|E1|Reported Event|Nicotine Lozenge|Participants in safety population received 4 mg of nicotine lozenge.
1064735|NCT00656968|B3|Baseline|Total|Total of all reporting groups
1064736|NCT00656968|B2|Baseline|Sequential Therapy (B)|esoprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, and metronidazole (500 mg, bid) from day 6 to day 10
1064737|NCT00656968|B1|Baseline|Concomitant Therapy (A)|esoprazole (40 mg, bid), amoxicillin (1 g, bid), clarithromycin (500 mg, bid) and metronidazole (500 mg, bid) for 10 days
1064738|NCT00656968|P2|Participant Flow|Sequential Therapy (B)|esoprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, and metronidazole (500 mg, bid) from day 6 to day 10
1064739|NCT00656968|P1|Participant Flow|Concomitant Therapy (A)|esoprazole (40 mg, bid), amoxicillin (1 g, bid), clarithromycin (500 mg, bid) and metronidazole (500 mg, bid) for 10 days
1064740|NCT00656968|O2|Outcome|Sequential Therapy (B)|esoprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, and metronidazole (500 mg, bid) from day 6 to day 10
1064741|NCT00656968|O1|Outcome|Concomitant Therapy (A)|esoprazole (40 mg, bid), amoxicillin (1 g, bid), clarithromycin (500 mg, bid) and metronidazole (500 mg, bid) for 10 days
1064742|NCT00656968|O2|Outcome|Sequential Therapy (B)|esoprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, and metronidazole (500 mg, bid) from day 6 to day 10
1064743|NCT00656968|O1|Outcome|Concomitant Therapy (A)|esoprazole (40 mg, bid), amoxicillin (1 g, bid), clarithromycin (500 mg, bid) and metronidazole (500 mg, bid) for 10 days
1064744|NCT00656968|E2|Reported Event|Sequential Therapy (B)|esoprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, and metronidazole (500 mg, bid) from day 6 to day 10
1064745|NCT00656968|E1|Reported Event|Concomitant Therapy (A)|esoprazole (40 mg, bid), amoxicillin (1 g, bid), clarithromycin (500 mg, bid) and metronidazole (500 mg, bid) for 10 days
1064746|NCT00656916|B3|Baseline|Total|Total of all reporting groups
1064747|NCT00656916|B2|Baseline|Observation|Comparator group, no intervention.
1064748|NCT00656916|B1|Baseline|Fluticasone Propionate|440 micrograms twice daily by oral inhalation.
1064749|NCT00656916|P2|Participant Flow|Observation|Comparator group, no intervention.
1064750|NCT00656916|P1|Participant Flow|Fluticasone Propionate|440 micrograms twice daily by oral inhalation.
1064751|NCT00656916|O2|Outcome|Observation|Comparator group, no intervention.
1064752|NCT00656916|O1|Outcome|Fluticasone Propionate|440 micrograms twice daily by oral inhalation.
1064753|NCT00656916|E2|Reported Event|Observation|Comparator group, no intervention.
1064754|NCT00656916|E1|Reported Event|Fluticasone Propionate|440 micrograms twice daily by oral inhalation.
1064755|NCT00656851|B3|Baseline|Total|Total of all reporting groups
1064756|NCT00656851|B2|Baseline|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
1064757|NCT00656851|B1|Baseline|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
1064761|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
1064762|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
1064763|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
1064764|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
1064765|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
1064766|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
1064767|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
1064768|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
1064769|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
1064770|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
1064771|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
1064772|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
1064773|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
1064774|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
1064775|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
1064776|NCT00656851|O2|Outcome|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
1064777|NCT00656851|O1|Outcome|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
1064778|NCT00656851|E2|Reported Event|Exercise Training|Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
1064779|NCT00656851|E1|Reported Event|Pioglitazone|Pioglitazone (Actos, 30mg/day for 16 weeks)
1064780|NCT00656799|B1|Baseline|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
1064781|NCT00656799|P1|Participant Flow|Sugammadex|Intravenous (IV) single bolus dose of 4.0 mg/kg sugammadex
1064782|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
1064783|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
1064784|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
1064785|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
1064786|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
1064787|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
1064788|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
1064789|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
1064790|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
1064791|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
1064792|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
1064793|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
1064794|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
1064795|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
1064796|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
1064797|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
1064798|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
1064799|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
1064800|NCT00656799|O1|Outcome|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
1064801|NCT00656799|E1|Reported Event|Sugammadex|IV single bolus dose of 4.0 mg/kg sugammadex
1064802|NCT00656669|B1|Baseline|Overall Study|These patients are for the patients who were into the trial.
1064803|NCT00656669|P1|Participant Flow|Segment Information|This is an exploratory phase 2 and biomarker clinical trial of sunitinib in the neoadjuvant setting for the treatment of breast cancer. The study will be conducted in 3 sequential treatment segments. During the first segment, patients will receive single-agent sunitinib for 2 weeks for the purpose of biomarker and IFP evaluation. Patients will then begin the second segment, 4 cycles (16 weeks) of neoadjuvant treatment with the combination of sunitinib and paclitaxel. Sunitinib will be discontinued after Cycle 5 Day 21. The third segment will include 4 cycles (8 weeks) of neoadjuvant treatment with AC followed by surgical resection and determination of pathological response.
1064804|NCT00656669|O1|Outcome|Paclitaxel Plus Sunitinib|Patients who were in the paclitaxel plus sunitinib segment
1064805|NCT00656669|O1|Outcome|AC Dosing|Patients who finished the AC dosing segment
1064806|NCT00656669|O1|Outcome|Paclitaxel Plus Sunitinib|Patients who finished the paclitaxel plus sunitinib segment
1064807|NCT00656669|O1|Outcome|Sunitinib Monotherapy|Patients who completed the Sunitinib monotherapy segment
1064808|NCT00656669|E3|Reported Event|AC Dosing|4 cycles (8 weeks) of neoadjuvant treatment with AC.
1064809|NCT00656669|E2|Reported Event|Paclitaxel/Sunitinib|4 cycles (16 weeks) of neoadjuvant treatment with the combination of sunitinib and paclitaxel.
1064810|NCT00656669|E1|Reported Event|Single Agent Sunitinib|Single-agent sunitinib for 2 weeks for the purpose of biomarker and IFP evaluation.
1064811|NCT00656656|B1|Baseline|Immunoadsorption/Dexamethasone/Rituximab|"Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil~Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks~Rituximab: 1000 mg i.v. given twice at a 2-week interval~Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks~Azathioprine: 2.5 mg/kg body weight daily p.o.~Mycophenolate mofetil 2 g/d p.o."
1064812|NCT00656656|P1|Participant Flow|Immunoadsorption/Dexamethasone/Rituximab|"Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil~Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks~Rituximab: 1000 mg i.v. given twice at a 2-week interval~Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks~Azathioprine: 2.5 mg/kg body weight daily p.o.~Mycophenolate mofetil 2 g/d p.o."
1064813|NCT00656656|O1|Outcome|Immunoadsorption/Dexamethasone/Rituximab|"Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil~Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks~Rituximab: 1000 mg i.v. given twice at a 2-week interval~Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks~Azathioprine: 2.5 mg/kg body weight daily p.o.~Mycophenolate mofetil 2 g/d p.o."
1064814|NCT00656656|O1|Outcome|Immunoadsorption/Dexamethasone/Rituximab|"Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil~Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks~Rituximab: 1000 mg i.v. given twice at a 2-week interval~Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks~Azathioprine: 2.5 mg/kg body weight daily p.o.~Mycophenolate mofetil 2 g/d p.o."
1064815|NCT00656656|E1|Reported Event|Immunoadsorption/Dexamethasone/Rituximab|"Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil~Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks~Rituximab: 1000 mg i.v. given twice at a 2-week interval~Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks~Azathioprine: 2.5 mg/kg body weight daily p.o.~Mycophenolate mofetil 2 g/d p.o."
1064816|NCT00656630|B4|Baseline|Total|Total of all reporting groups
1064817|NCT00656630|B3|Baseline|Sugar Pill (Placebo)|Placebo: Double-dummy placebo capsules, 1 week duration
1064818|NCT00656630|B2|Baseline|ReVia (Naltrexone)|"Naltrexone~Naltrexone: 50mg capsule, Once daily, 1 week duration"
1064819|NCT00656630|B1|Baseline|Campral (Acamprosate)|"Acamprosate~Acamprosate: Total dose, 1998 mg daily, 1 week duration"
1064820|NCT00656630|P3|Participant Flow|Sugar Pill (Placebo)|Placebo: Double-dummy placebo capsules, 1 week duration
1064821|NCT00656630|P2|Participant Flow|ReVia (Naltrexone)|"Naltrexone~Naltrexone: 50mg capsule, Once daily, 1 week duration"
1064822|NCT00656630|P1|Participant Flow|Campral (Acamprosate)|"Acamprosate~Acamprosate: Total dose, 1998 mg daily, 1 week duration"
1064823|NCT00656630|O3|Outcome|Sugar Pill (Placebo)|Placebo: Double-dummy placebo capsules, 1 week duration
1064824|NCT00656630|O2|Outcome|ReVia (Naltrexone)|"Naltrexone~Naltrexone: 50mg capsule, Once daily, 1 week duration"
1064825|NCT00656630|O1|Outcome|Campral (Acamprosate)|"Acamprosate~Acamprosate: Total dose, 1998 mg daily, 1 week duration"
1064826|NCT00656630|O3|Outcome|Sugar Pill (Placebo)|Placebo: Double-dummy placebo capsules, 1 week duration
1064827|NCT00656630|O2|Outcome|ReVia (Naltrexone)|"Naltrexone~Naltrexone: 50mg capsule, Once daily, 1 week duration"
1064828|NCT00656630|O1|Outcome|Campral (Acamprosate)|"Acamprosate~Acamprosate: Total dose, 1998 mg daily, 1 week duration"
1064829|NCT00656630|O3|Outcome|Sugar Pill (Placebo)|Placebo: Double-dummy placebo capsules, 1 week duration
1064830|NCT00656630|O2|Outcome|ReVia (Naltrexone)|"Naltrexone~Naltrexone: 50mg capsule, Once daily, 1 week duration"
1064831|NCT00656630|O1|Outcome|Campral (Acamprosate)|"Acamprosate~Acamprosate: Total dose, 1998 mg daily, 1 week duration"
1064832|NCT00656630|O3|Outcome|Sugar Pill (Placebo)|Placebo: Double-dummy placebo capsules, 1 week duration
1064833|NCT00656630|O2|Outcome|ReVia (Naltrexone)|"Naltrexone~Naltrexone: 50mg capsule, Once daily, 1 week duration"
1064834|NCT00656630|O1|Outcome|Campral (Acamprosate)|"Acamprosate~Acamprosate: Total dose, 1998 mg daily, 1 week duration"
1064835|NCT00656630|O3|Outcome|Sugar Pill (Placebo)|Placebo: Double-dummy placebo capsules, 1 week duration
1064836|NCT00656630|O2|Outcome|ReVia (Naltrexone)|"Naltrexone~Naltrexone: 50mg capsule, Once daily, 1 week duration"
1064837|NCT00656630|O1|Outcome|Campral (Acamprosate)|"Acamprosate~Acamprosate: Total dose, 1998 mg daily, 1 week duration"
1064838|NCT00656630|E3|Reported Event|Placebo|Placebo: Double-dummy placebo capsules, 1 week duration
1064839|NCT00656630|E2|Reported Event|Naltrexone|"Naltrexone~Naltrexone: 50mg capsule, Once daily, 1 week duration"
1064840|NCT00656630|E1|Reported Event|Acamprosate|"Acamprosate~Acamprosate: Total dose, 1998 mg daily, 1 week duration"
1064841|NCT00656617|B1|Baseline|Idarubicin + Ara-C + Vorinostat|Idarubicin 12 mg/m^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
1064842|NCT00656617|P1|Participant Flow|Idarubicin + Ara-C + Vorinostat|Idarubicin 12 mg/m^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
1064843|NCT00656617|O1|Outcome|Idarubicin + Ara-C + Vorinostat|Idarubicin 12 mg/m^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
1064844|NCT00656617|O1|Outcome|Idarubicin + Ara-C + Vorinostat|Idarubicin 12 mg/m^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
1064845|NCT00656617|E2|Reported Event|Idarubicin + Ara-C + Vorinostat (Phase 2)|Idarubicin 12 mg/m^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
1064846|NCT00656617|E1|Reported Event|Idarubicin + Ara-C + Vorinostat (Phase 1)|Idarubicin 12 mg/m^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
1064847|NCT00656487|B4|Baseline|Total|Total of all reporting groups
1064848|NCT00656487|B3|Baseline|Control|Participants were non-cannabis using controls.
1064849|NCT00656487|B2|Baseline|Placebo|Participants were cannabis dependent and received matched placebo.
1064850|NCT00656487|B1|Baseline|Rimonabant|Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
1064851|NCT00656487|P3|Participant Flow|Control|Participants were non-cannabis using controls.
1064852|NCT00656487|P2|Participant Flow|Placebo|Participants were cannabis dependent and received matched placebo.
1065212|NCT00655356|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
1064853|NCT00656487|P1|Participant Flow|Rimonabant|Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
1064854|NCT00656487|O3|Outcome|Control|Participants were non-cannabis using controls.
1064855|NCT00656487|O2|Outcome|Placebo|Participants were cannabis dependent and received matched placebo.
1064856|NCT00656487|O1|Outcome|Rimonabant|Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
1064857|NCT00656487|O3|Outcome|Control|Participants were non-cannabis using controls.
1064858|NCT00656487|O2|Outcome|Placebo|Participants were cannabis dependent and received matched placebo.
1064859|NCT00656487|O1|Outcome|Rimonabant|Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
1064860|NCT00656487|O3|Outcome|Control|Participants were non-cannabis using controls.
1064861|NCT00656487|O2|Outcome|Placebo|Participants were cannabis dependent and received matched placebo.
1064862|NCT00656487|O1|Outcome|Rimonabant|Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
1064863|NCT00656487|O3|Outcome|Control|Participants were non-cannabis using controls.
1064864|NCT00656487|O2|Outcome|Placebo|Participants were cannabis dependent and received matched placebo.
1064865|NCT00656487|O1|Outcome|Rimonabant|Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
1064866|NCT00656487|O3|Outcome|Control|Participants were non-cannabis using controls.
1064867|NCT00656487|O2|Outcome|Placebo|Participants were cannabis dependent and received matched placebo.
1064868|NCT00656487|O1|Outcome|Rimonabant|Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
1064869|NCT00656487|O3|Outcome|Control|Participants were non-cannabis using controls.
1064870|NCT00656487|O2|Outcome|Placebo|Participants were cannabis dependent and received matched placebo.
1064871|NCT00656487|O1|Outcome|Rimonabant|Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
1064872|NCT00656487|E3|Reported Event|Control|Participants were non-cannabis using controls.
1064873|NCT00656487|E2|Reported Event|Placebo|Participants were cannabis dependent and received matched placebo.
1064874|NCT00656487|E1|Reported Event|Rimonabant|Participants were cannabis dependent and received a single 90 mg dose of rimonabant at baseline visit.
1064875|NCT00656474|B1|Baseline|GLYC-101 and Placebo|Subjects were randomized to receive GLYC-101 Active gel (1%) on one retro-auricular site and Placebo gel on the opposite retro-auricular site.
1064876|NCT00656474|P1|Participant Flow|GLYC-101 and Placebo|"Subjects were randomized to receive GLYC-101 Active gel (1%) on one retro-auricular site and Placebo gel on the opposite retro-auricular site.~GLYC-101 gel (1%) Administration on Day 1, 3 and 5 post laser ablation"
1064877|NCT00656474|O2|Outcome|Placebo Retro-auricular Site (1 Per Participant)|Placebo gel Administration on Day 1, 3 and 5 post laser ablation
1064878|NCT00656474|O1|Outcome|GLYC-101 Active Retro-auricular Site (1 Per Participant)|GLYC-101 gel (1%) Administration on Day 1, 3 and 5 post laser ablation
1064879|NCT00656474|O2|Outcome|Placebo Retro-auricular Site (1 Per Participant)|Placebo gel Administration on Day 1, 3 and 5 post laser ablation
1064880|NCT00656474|O1|Outcome|GLYC-101 Active Retro-auricular Site (1 Per Participant)|GLYC-101 gel (1%) Administration on Day 1, 3 and 5 post laser ablation
1064881|NCT00656474|E1|Reported Event|GLYC-101 and Placebo|"Subjects were randomized to receive GLYC-101 Active gel (1%) on one retro-auricular site and Placebo gel on the opposite retro-auricular site.~GLYC-101 gel (1%) Administration on Day 1, 3 and 5 post laser ablation"
1064882|NCT00656448|B3|Baseline|Total|Total of all reporting groups
1064883|NCT00656448|B2|Baseline|No Procruit: Standard Arm|Participants do not receive Procrit before receiving blood transfusions.
1064884|NCT00656448|B1|Baseline|Procrit Arm|Participants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy.
1064885|NCT00656448|P2|Participant Flow|No Procrit: Standard Arm|Participants do not receive Procrit before receiving blood transfusions.
1064886|NCT00656448|P1|Participant Flow|Procrit Arm|Participants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy.
1064887|NCT00656448|O2|Outcome|No Procruit: Standard Arm|Participants do not receive Procrit before receiving blood transfusions.
1064888|NCT00656448|O1|Outcome|Procrit Arm|Participants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy.
1064889|NCT00656448|O2|Outcome|No Procrit: Standard Arm|Participants do not receive Procrit before receiving blood transfusions.
1064890|NCT00656448|O1|Outcome|Procrit Arm|Participants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy.
1064891|NCT00656448|E2|Reported Event|No Procruit: Standard Arm|Participants do not receive Procrit before receiving blood transfusions.
1064892|NCT00656448|E1|Reported Event|Procrit Arm|Participants receive Procrit along with blood transfusions. Procrit 40,000 units subcutaneously every week starting within two weeks (before or after) from the start of induction chemotherapy.
1064893|NCT00656370|B1|Baseline|NS, LR|In Stage 1, the comparison will be NS solution to LR solution. Each subject will receive simultaneous SC infusions of 500 mL (from a 500 mL bag) of solution in each anterior thigh, consisting of NS in one thigh and LR in the other thigh. The thighs (left vs. right) to receive NS and LR will be randomized and double blinded. Immediately prior to the infusions, each thigh will have 150 units of hylenex simultaneously injected.
1064894|NCT00656370|P1|Participant Flow|NS, LR|In Stage 1, the comparison will be NS solution to LR solution. Each subject will receive simultaneous SC infusions of 500 mL (from a 500 mL bag) of solution in each anterior thigh, consisting of NS in one thigh and LR in the other thigh. The thighs (left vs. right) to receive NS and LR will be randomized and double blinded. Immediately prior to the infusions, each thigh will have 150 units of hylenex simultaneously injected.
1065133|NCT00655642|E3|Reported Event|Promethazine|Patients randomized to a single 2 mL Promethazine 12.5mg intravenous dosage administration treatment
1064895|NCT00656370|O1|Outcome|NS, LR|In Stage 1, the comparison will be NS solution to LR solution. Each subject will receive simultaneous SC infusions of 500 mL (from a 500 mL bag) of solution in each anterior thigh, consisting of NS in one thigh and LR in the other thigh. The thighs (left vs. right) to receive NS and LR will be randomized and double blinded. Immediately prior to the infusions, each thigh will have 150 units of hylenex simultaneously injected.
1064896|NCT00656370|O2|Outcome|LR Infusion Group|Maximal post baseline increase in VAS score for LR infusions.
1064897|NCT00656370|O1|Outcome|NS Infusion Group|Maximal post baseline increase VAS score for NS infusion.
1064898|NCT00656370|E1|Reported Event|NS, LR|In Stage 1, the comparison will be NS solution to LR solution. Each subject will receive simultaneous SC infusions of 500 mL (from a 500 mL bag) of solution in each anterior thigh, consisting of NS in one thigh and LR in the other thigh. The thighs (left vs. right) to receive NS and LR will be randomized and double blinded. Immediately prior to the infusions, each thigh will have 150 units of hylenex simultaneously injected.
1064899|NCT00656292|B3|Baseline|Total|Total of all reporting groups
1064900|NCT00656292|B2|Baseline|Placebo|Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
1064901|NCT00656292|B1|Baseline|Simvastatin|Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
1064902|NCT00656292|P2|Participant Flow|Placebo|Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
1064903|NCT00656292|P1|Participant Flow|Simvastatin|Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
1064904|NCT00656292|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
1064905|NCT00656292|O1|Outcome|Simvastatin|Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
1064906|NCT00656292|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
1064907|NCT00656292|O1|Outcome|Simvastatin|Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
1064908|NCT00656292|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
1064923|NCT00656201|O2|Outcome|Intramuscular Progesterone|Progesterone—50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.
1074047|NCT00629525|O1|Outcome|RAD001|RAD001 at a dose of 10 mg PO daily
1064909|NCT00656292|O1|Outcome|Simvastatin|Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
1064910|NCT00656292|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
1064911|NCT00656292|O1|Outcome|Simvastatin|Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
1064912|NCT00656292|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
1064913|NCT00656292|O1|Outcome|Simvastatin|Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
1064914|NCT00656292|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
1064915|NCT00656292|O1|Outcome|Simvastatin|Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
1064916|NCT00656292|E2|Reported Event|Placebo|Subjects randomized to this arm will receive placebo two days before surgery -- allowing three doses of placebo before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of placebo), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
1064917|NCT00656292|E1|Reported Event|Simvastatin|Subjects randomized to this arm will receive statin therapy (simvastatin 40 mg) two days before surgery -- allowing three doses of simvastatin before incision -- and these will be continued until patients are either discharged from the hospital or have completed a 3-day postoperative course (6 days of simvastatin therapy), whichever occurs earlier. If patients are unable to take oral medications, the enteral route via nasogastric tube (at our institution, nasogastric tubes are routinely placed for both lumbar and thoracic instrumentation) will be used to deliver either placebo or the statin, as no parenteral form of this drug is currently available.
1064918|NCT00656201|B3|Baseline|Total|Total of all reporting groups
1064919|NCT00656201|B2|Baseline|Intramuscular Progesterone|Progesterone—50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.
1064920|NCT00656201|B1|Baseline|Crinone 8% Vaginal Gel|Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.
1064921|NCT00656201|P2|Participant Flow|Intramuscular Progesterone|Progesterone—50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.
1064922|NCT00656201|P1|Participant Flow|Crinone 8% Vaginal Gel|Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.
1064992|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
1064924|NCT00656201|O1|Outcome|Crinone 8% Vaginal Gel|Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.
1064925|NCT00656201|E2|Reported Event|Intramuscular Progesterone|Progesterone—50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.
1064926|NCT00656201|E1|Reported Event|Crinone 8% Vaginal Gel|Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.
1064927|NCT00656175|B3|Baseline|Total|Total of all reporting groups
1064928|NCT00656175|B2|Baseline|Delayed|Continue current therapy unchanged for 24 weeks then switch PI or NNRTI to Raltegravir
1064929|NCT00656175|B1|Baseline|Immediate|Immediate switch of PI or NNRTI to Raltegravir
1064930|NCT00656175|P2|Participant Flow|Delayed|Continue current therapy unchanged for 24 weeks, then switch PI or NNRTI to Raltegravir (400mg twice daily)
1064931|NCT00656175|P1|Participant Flow|Immediate|Immediate switch of PI or NNRTI to Raltegravir (400 mg twice daily)
1064932|NCT00656175|O2|Outcome|Delayed|Continue current therapy unchanged for 24 weeks, then switch PI or NNRTI to Raltegravir
1064933|NCT00656175|O1|Outcome|Immediate|Immediate switch of PI or NNRTI to Raltegravir
1064934|NCT00656175|E2|Reported Event|Delayed|Continue current therapy unchanged for 24 weeks then switch PI or NNRTI to Raltegravir
1064935|NCT00656175|E1|Reported Event|Immediate|Immediate switch of PI or NNRTI to Raltegravir
1064936|NCT00656136|B3|Baseline|Total|Total of all reporting groups
1064937|NCT00656136|B2|Baseline|Afatinib 50 mg/Day Plus Best Supportive Care (BSC)|Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus BSC or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0).
1064938|NCT00656136|B1|Baseline|Placebo Plus Best Supportive Care (BSC)|Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm.
1064939|NCT00656136|P2|Participant Flow|Afatinib 50 mg/Day Plus Best Supportive Care (BSC)|Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus Best Supportive Care (BSC) or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0).
1064940|NCT00656136|P1|Participant Flow|Placebo Plus Best Supportive Care (BSC)|Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm.
1064941|NCT00656136|O2|Outcome|Afatinib 50 mg/Day Plus Best Supportive Care (BSC)|Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus BSC or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0).
1064942|NCT00656136|O1|Outcome|Placebo Plus Best Supportive Care (BSC)|Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm.
1064943|NCT00656136|O2|Outcome|Afatinib 50 mg/Day Plus Best Supportive Care (BSC)|Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus BSC or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0).
1064944|NCT00656136|O1|Outcome|Placebo Plus Best Supportive Care (BSC)|Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm.
1064945|NCT00656136|O2|Outcome|Afatinib 50 mg/Day Plus Best Supportive Care (BSC)|Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus BSC or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0).
1064946|NCT00656136|O1|Outcome|Placebo Plus Best Supportive Care (BSC)|Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm.
1064947|NCT00656136|E2|Reported Event|Afatinib 50 mg/Day|Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus BSC or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0).
1064948|NCT00656136|E1|Reported Event|Placebo|Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm.
1064949|NCT00656084|B1|Baseline|Gemzar + Novantrone + Rituxan|Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
1064950|NCT00656084|P1|Participant Flow|Gemzar + Novantrone + Rituxan|Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
1064951|NCT00656084|O1|Outcome|Gemzar + Novantrone + Rituxan|Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
1064952|NCT00656084|O1|Outcome|Gemzar + Novantrone + Rituxan|Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
1064953|NCT00656084|O1|Outcome|Gemzar + Novantrone + Rituxan|Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
1064954|NCT00656084|O1|Outcome|Gemzar + Novantrone + Rituxan|Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
1064955|NCT00656084|E1|Reported Event|Gemzar + Novantrone + Rituxan|Gemzar, Novantrone, and Rituxan in relapsed or refractory mantle cell lymphoma (MCL)
1064956|NCT00656058|B1|Baseline|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.~Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
1064957|NCT00656058|P1|Participant Flow|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.~Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
1064958|NCT00656058|O1|Outcome|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.~Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
1064959|NCT00656058|O1|Outcome|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.~Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
1064960|NCT00656058|O1|Outcome|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.~Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
1064961|NCT00656058|O1|Outcome|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.~Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
1064962|NCT00656058|O1|Outcome|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.~Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
1064963|NCT00656058|O1|Outcome|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.~Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
1064964|NCT00656058|E1|Reported Event|Montelukast to Treat Bronchiolitis Obliterans|"Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant.~Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS"
1064965|NCT00655889|B1|Baseline|Autologous Fibroblasts|Patients received autologous fibroblasts to maxillary interdental papillary recessions that were treated with fibroblasts or placebo in a previous study.
1064966|NCT00655889|P1|Participant Flow|Autologous Fibroblasts|Patients received autologous fibroblasts to maxillary interdental papillary recessions that were treated with fibroblasts or placebo in a previous study.
1064967|NCT00655889|O1|Outcome|Autologous Fibroblasts|Patients received autologous fibroblasts to maxillary interdental papillary recessions that were treated with fibroblasts or placebo in a previous study.
1064968|NCT00655889|O1|Outcome|Autologous Fibroblasts|Patients received autologous fibroblasts to maxillary interdental papillary recessions that were treated with fibroblasts or placebo in a previous study.
1064969|NCT00655889|E1|Reported Event|Autologous Fibroblasts|Patients received autologous fibroblasts to maxillary interdental papillary recessions that were treated with fibroblasts or placebo in a previous study.
1064970|NCT00655863|B4|Baseline|Total|Total of all reporting groups
1064971|NCT00655863|B3|Baseline|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
1064972|NCT00655863|B2|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1064973|NCT00655863|B1|Baseline|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1064974|NCT00655863|P3|Participant Flow|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
1064975|NCT00655863|P2|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1064976|NCT00655863|P1|Participant Flow|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1064977|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
1064978|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1064979|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1064980|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
1064981|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1064982|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1064983|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
1064984|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1064985|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1064986|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
1064987|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1064988|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1064989|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
1064990|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1064991|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1065134|NCT00655642|E2|Reported Event|Metoclopramide|Patients randomized to a single 2 mL Metoclopramide 10 mg intravenous dosage administration treatment
1064993|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1064994|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1064995|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
1064996|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1064997|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1064998|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
1064999|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1065000|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1065001|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
1065002|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1065003|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1065004|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
1065005|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1065006|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1065007|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
1065008|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1065009|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1065010|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
1065011|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1065012|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1065013|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
1065014|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1065015|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1065016|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
1065017|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1065018|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1065019|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
1065020|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1065021|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1065022|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
1065023|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1065024|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1065025|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
1065026|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1065027|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1065028|NCT00655863|O3|Outcome|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
1065029|NCT00655863|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1065030|NCT00655863|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1065031|NCT00655863|E3|Reported Event|Alogliptin 25 mg QD + Pioglitazone 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
1065032|NCT00655863|E2|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1065033|NCT00655863|E1|Reported Event|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
1065034|NCT00655850|B1|Baseline|Paclitaxel and Gemcitabine + Avastin|"Patients will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks which constitutes one cycle (4 weeks). Avastin will be administered every 2 weeks. Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with Avastin will continue until disease progression, intolerable toxicity, or withdrawal of consent.~Paclitaxel: -Prior to receiving paclitaxel, all patients will receive the following premedications one hour before the infusion:~Dexamethasone 20mg, intravenously (IV)~Diphenhydramine 50 mg IV~Ranitidine 50 mg IV~Paclitaxel will be administered after the gemcitabine infusion as a 1 hour (IV) infusion~The initial dose of paclitaxel is 80 mg/m2/weekly for 3 out of 4 weeks (Day 1, 8, 15)~Paclitaxel Dose Levels:~Dose Level 1 ________80 mg/m2/weekly~Dose Level -1 _____"
1065035|NCT00655850|P1|Participant Flow|Paclitaxel and Gemcitabine + Avastin|"Patients will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks which constitutes one cycle (4 weeks). Avastin will be administered every 2 weeks. Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with Avastin will continue until disease progression, intolerable toxicity, or withdrawal of consent.~Paclitaxel: -Prior to receiving paclitaxel, all patients will receive the following premedications one hour before the infusion:~Dexamethasone 20mg, intravenously (IV)~Diphenhydramine 50 mg IV~Ranitidine 50 mg IV~Paclitaxel will be administered after the gemcitabine infusion as a 1 hour (IV) infusion~The initial dose of paclitaxel is 80 mg/m2/weekly for 3 out of 4 weeks (Day 1, 8, 15)~Paclitaxel Dose Levels:~Dose Level 1 ________80 mg/m2/weekly~Dose Level -1 _____"
1065036|NCT00655850|O1|Outcome|Paclitaxel and Gemcitabine + Avastin|"Patients will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks which constitutes one cycle (4 weeks). Avastin will be administered every 2 weeks. Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with Avastin will continue until disease progression, intolerable toxicity, or withdrawal of consent~Paclitaxel: -Prior to receiving paclitaxel, all patients will receive the following premedications one hour before the infusion:~Dexamethasone 20mg, intravenously (IV)~Diphenhydramine 50 mg IV~Ranitidine 50 mg IV~Paclitaxel will be administered after the gemcitabine infusion as a 1 hour (IV) infusion.~The initial dose of paclitaxel is 80 mg/m2/weekly for 3 out of 4 weeks (Day 1, 8, 15)~Paclitaxel Dose Levels:~Dose Level 1 ________80 mg/m2/weekly~Dose Level -1 _____"
1065037|NCT00655850|O1|Outcome|Paclitaxel and Gemcitabine + Avastin|"Patients will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks which constitutes one cycle (4 weeks). Avastin will be administered every 2 weeks. Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with Avastin will continue until disease progression, intolerable toxicity, or withdrawal of consent~Paclitaxel: -Prior to receiving paclitaxel, all patients will receive the following premedications one hour before the infusion:~Dexamethasone 20mg, intravenously (IV)~Diphenhydramine 50 mg IV~Ranitidine 50 mg IV~Paclitaxel will be administered after the gemcitabine infusion as a 1 hour (IV) infusion.~The initial dose of paclitaxel is 80 mg/m2/weekly for 3 out of 4 weeks (Day 1, 8, 15)~Paclitaxel Dose Levels:~Dose Level 1 ________80 mg/m2/weekly~Dose Level -1 _____"
1065038|NCT00655850|O1|Outcome|Paclitaxel and Gemcitabine + Avastin|Patients will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks which constitutes one cycle (4 weeks). Avastin will be administered every 2 weeks. Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with Avastin will continue until disease progression, intolerable toxicity, or withdrawal of consent.
1065039|NCT00655850|O1|Outcome|Paclitaxel and Gemcitabine + Avastin|"Patients will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks which constitutes one cycle (4 weeks). Avastin will be administered every 2 weeks. Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with Avastin will continue until disease progression, intolerable toxicity, or withdrawal of consent.~Paclitaxel: -Prior to receiving paclitaxel, all patients will receive the following premedications one hour before the infusion:~Dexamethasone 20mg, intravenously (IV)~Diphenhydramine 50 mg IV~Ranitidine 50 mg IV~Paclitaxel will be administered after the gemcitabine infusion as a 1 hour (IV) infusion~The initial dose of paclitaxel is 80 mg/m2/weekly for 3 out of 4 weeks (Day 1, 8, 15)~Paclitaxel Dose Levels:~Dose Level 1 ________80 mg/m2/weekly~Dose Level -1 _____"
1065040|NCT00655850|E1|Reported Event|Paclitaxel and Gemcitabine + Avastin|Patients will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks which constitutes one cycle (4 weeks). Avastin will be administered every 2 weeks. Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with Avastin will continue until disease progression, intolerable toxicity, or withdrawal of consent.
1065118|NCT00655668|E1|Reported Event|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
1065119|NCT00655642|B5|Baseline|Total|Total of all reporting groups
1065120|NCT00655642|B4|Baseline|Placebo|Patients randomized to a single 2-mL isotonic sodium chloride Saline Placebo intravenous treatment
1065121|NCT00655642|B3|Baseline|Promethazine|Patients randomized to a single 2 mL Promethazine 12.5mg intravenous dosage administration treatment
1065122|NCT00655642|B2|Baseline|Metoclopramide|Patients randomized to a single 2 mL Metoclopramide 10 mg intravenous dosage administration treatment
1065041|NCT00655824|B1|Baseline|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065042|NCT00655824|P1|Participant Flow|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course (TC). The remaining TCs were given at individualized time intervals when a clinical response had been achieved following the previous TC and a subsequent worsening in disease activity had been observed. For the remaining TCs, the interval between the TCs was at least 16 weeks from the first infusion in the previous TC irrespective of progression in disease activity. After each TC, participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next TC. A maximum of 9 TCs were allowed. After completing or withdrawing from the Treatment Period, participants were followed up every 12 weeks (for a maximum of 2 years in the Follow-up Period) until CD19+ cells returned to Baseline or normal levels.
1065043|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065044|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065045|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065046|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065047|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065048|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065123|NCT00655642|B1|Baseline|Ondansetron|Patients randomized to a single 2 milliliter (mL) Ondansetron 4 mg intravenous dosage administration treatment
1074048|NCT00629525|O1|Outcome|RAD001|RAD001 at a dose of 10 mg PO daily
1065049|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065050|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065051|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065052|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065053|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065054|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065055|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065056|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065124|NCT00655642|P4|Participant Flow|Placebo|Patients randomized to a single 2-mL isotonic sodium chloride Saline Placebo intravenous treatment
1065125|NCT00655642|P3|Participant Flow|Promethazine|Patients randomized to a single 2 mL Promethazine 12.5mg intravenous dosage administration treatment
1065057|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065058|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065059|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065060|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065061|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065062|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065063|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065064|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065126|NCT00655642|P2|Participant Flow|Metoclopramide|Patients randomized to a single 2 mL Metoclopramide 10 mg intravenous dosage administration treatment
1065127|NCT00655642|P1|Participant Flow|Ondansetron|Patients randomized to a single 2 milliliter (mL) Ondansetron 4 mg intravenous dosage administration treatment
1065065|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065066|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065067|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065068|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065069|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065070|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065071|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065072|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065128|NCT00655642|O4|Outcome|Placebo|Patients randomized to a single 2-mL isotonic sodium chloride Saline Placebo intravenous treatment
1065129|NCT00655642|O3|Outcome|Promethazine|Patients randomized to a single 2 mL Promethazine 12.5mg intravenous dosage administration treatment
1065073|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065074|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065075|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065076|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065077|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065078|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065079|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065080|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065130|NCT00655642|O2|Outcome|Metoclopramide|Patients randomized to a single 2 mL Metoclopramide 10 mg intravenous dosage administration treatment
1065131|NCT00655642|O1|Outcome|Ondansetron|Patients randomized to a single 2 milliliter (mL) Ondansetron 4 mg intravenous dosage administration treatment
1065081|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065082|NCT00655824|O1|Outcome|Ofatumumab 700 mg IV Infusion|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treatment course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065083|NCT00655824|E2|Reported Event|Ofatumumab 700 mg IV Infusion: Follow-up Period|After completing or withdrawing from the Treatment Period, participants were followed up every 12 weeks (for a maximum of 2 years in the Follow-up Period) until CD19+ cells returned to Baseline or normal levels.
1065084|NCT00655824|E1|Reported Event|Ofatumumab 700 mg IV Infusion: Treatment Period|Ofatumumab was administered in the dose of 700 milligrams (mg) as two intravenous (IV) infusions separated by 2 weeks for the first treament course. The remaining treatment courses were given at individualized time intervals when a clinical response had been achieved following the previous treatment course and a subsequent worsening in disease activity had been observed. For the remaining treatment courses, the interval between the treatment courses was at least 16 weeks from the first infusion in the previous treatment course irrespective of progression in disease activity. After each treatment course, the participants attended their next trial visit 8 weeks after the first infusion of that course, followed by trial visits every 4 weeks up to Week 24, and subsequent visits every 8 weeks until the next treatment course. A maximum of 9 treatment courses were allowed.
1065085|NCT00655746|B1|Baseline|Dasatinib/Omeprazole|Day 1: 100-mg oral dasatinib; Days 2 through 6: 40-mg oral omeprazole; Day 6:100-mg oral dasatinib and 40-mg oral omeprazole
1065086|NCT00655746|P1|Participant Flow|Dasatinib/Omeprazole|Day 1: 100-mg oral dasatinib; Days 2 through 6: 40-mg oral omeprazole; Day 6:100-mg oral dasatinib and 40-mg oral omeprazole
1065087|NCT00655746|O2|Outcome|Dasatinib + Omeprazole (Day 6)|100-mg oral dasatinib and 40-mg oral omeprazole
1065088|NCT00655746|O1|Outcome|Dasatinib (Day 1)|100-mg oral dasatinib
1065089|NCT00655746|O2|Outcome|Dasatinib + Omeprazole (Day 6)|100-mg oral dasatinib and 40-mg oral omeprazole
1065090|NCT00655746|O1|Outcome|Dasatinib (Day 1)|100-mg oral dasatinib
1065091|NCT00655746|O2|Outcome|Dasatinib + Omeprazole (Day 6)|100-mg oral dasatinib and 40-mg oral omeprazole
1065092|NCT00655746|O1|Outcome|Dasatinib (Day 1)|100-mg oral dasatinib
1065093|NCT00655746|O2|Outcome|Dasatinib + Omeprazole (Day 6)|100-mg oral dasatinib and 40-mg oral omeprazole
1065094|NCT00655746|O1|Outcome|Dasatinib (Day 1)|100-mg oral dasatinib
1065095|NCT00655746|O4|Outcome|All Participants|
1065096|NCT00655746|O3|Outcome|Dasatinib + Omeprazole (Day 6)|100-mg oral dasatinib and 40-mg oral omeprazole
1065097|NCT00655746|O2|Outcome|Omeprazole (Days 2-5)|40-mg oral omeprazole
1065098|NCT00655746|O1|Outcome|Dasatinib (Day 1)|100-mg oral dasatinib
1065099|NCT00655746|O2|Outcome|Dasatinib + Omeprazole (Day 6)|100-mg oral dasatinib and 40-mg oral omeprazole
1065100|NCT00655746|O1|Outcome|Dasatinib (Day 1)|100-mg oral dasatinib
1065101|NCT00655746|E1|Reported Event|BMS-354825 + Omeprazole|
1065102|NCT00655733|B3|Baseline|Total|Total of all reporting groups
1065103|NCT00655733|B2|Baseline|Placebo|Placebo
1065104|NCT00655733|B1|Baseline|HMPL004|HMPL004 1200mg/d
1065105|NCT00655733|P2|Participant Flow|Placebo|Placebo
1065106|NCT00655733|P1|Participant Flow|HMPL004|HMPL004 1200mg/d
1065107|NCT00655733|O2|Outcome|Placebo|Placebo
1065108|NCT00655733|O1|Outcome|HMPL004|HMPL004 1200mg/d
1065109|NCT00655733|E2|Reported Event|Placebo|Placebo
1065110|NCT00655733|E1|Reported Event|HMPL004|HMPL004 1200mg/d
1065111|NCT00655668|B1|Baseline|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
1065112|NCT00655668|P1|Participant Flow|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
1065113|NCT00655668|O1|Outcome|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
1065114|NCT00655668|O1|Outcome|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
1065115|NCT00655668|O1|Outcome|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
1065116|NCT00655668|O1|Outcome|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
1065117|NCT00655668|O1|Outcome|Single Agent Lenalidomide|Oral lenalidomide 25 mg daily for 21 days every 28 days as tolerated for up to 24 months, until disease progression, or an unacceptable adverse event occurs.
1065132|NCT00655642|E4|Reported Event|Placebo|Patients randomized to a single 2-mL isotonic sodium chloride Saline Placebo intravenous treatment
1065135|NCT00655642|E1|Reported Event|Ondansetron|Patients randomized to a single 2 milliliter (mL) Ondansetron 4 mg intravenous dosage administration treatment
1065136|NCT00655629|B3|Baseline|Total|Total of all reporting groups
1065137|NCT00655629|B2|Baseline|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065138|NCT00655629|B1|Baseline|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065139|NCT00655629|P2|Participant Flow|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065140|NCT00655629|P1|Participant Flow|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065141|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065142|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065143|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065144|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065145|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065146|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065147|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065148|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065149|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065150|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065151|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065152|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065153|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065154|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065155|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065156|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065157|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065158|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065159|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065160|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065161|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065162|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065163|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065164|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065165|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065166|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065167|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065168|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065169|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065170|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1074049|NCT00629525|O1|Outcome|RAD001|RAD001 at a dose of 10 mg PO daily
1065171|NCT00655629|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065172|NCT00655629|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065173|NCT00655629|E2|Reported Event|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065174|NCT00655629|E1|Reported Event|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1065175|NCT00655564|B1|Baseline|Alefacept|All subjects will receive 15 mg of alefacept IM per week (unless CD4<250 cells/µL, then dose will be withheld), for 16 weeks of treatment. After that they will be receive alefacept (15mg IM) once every 4 weeks for 8 months
1065176|NCT00655564|P1|Participant Flow|Alefacept|All subjects will receive 15 mg of alefacept IM per week (unless CD4<250 cells/µL, then dose will be withheld), for 16 weeks of treatment. After that they will be receive alefacept (15mg IM) once every 4 weeks for 8 months
1065177|NCT00655564|O1|Outcome|Alefacept|All subjects received alefacept injections per FDA dosing guidelines for the duration of the 52 weeks study
1065178|NCT00655564|O1|Outcome|Alefacept|Alefacept's FDA indication is for the treatment of adult subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. The approved dosing regimen is 15mg once weekly as an intramuscular injection or 7.5mg given once weekly as an intravenous bolus. The recommended regimen is a course of 12 weeks.
1065179|NCT00655564|E1|Reported Event|Alefacept|All subjects will receive 15 mg of alefacept IM per week (unless CD4<250 cells/µL, then dose will be withheld), for 16 weeks of treatment. After that they will be receive alefacept (15mg IM) once every 4 weeks for 8 months
1065180|NCT00655551|B4|Baseline|Total|Total of all reporting groups
1065181|NCT00655551|B3|Baseline|Lacosamide (400 mg)|Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
1065182|NCT00655551|B2|Baseline|Lacosamide (300 mg)|Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
1065183|NCT00655551|B1|Baseline|Lacosamide (200 mg)|Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
1065184|NCT00655551|P3|Participant Flow|Lacosamide (400 mg)|Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
1065185|NCT00655551|P2|Participant Flow|Lacosamide (300 mg)|Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
1065186|NCT00655551|P1|Participant Flow|Lacosamide (200 mg)|Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
1065187|NCT00655551|O3|Outcome|Lacosamide (400 mg)|Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
1065188|NCT00655551|O2|Outcome|Lacosamide (300 mg)|Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
1065189|NCT00655551|O1|Outcome|Lacosamide (200 mg)|Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
1065190|NCT00655551|O3|Outcome|Lacosamide (400 mg)|Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
1065191|NCT00655551|O2|Outcome|Lacosamide (300 mg)|Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
1065192|NCT00655551|O1|Outcome|Lacosamide (200 mg)|Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
1065193|NCT00655551|O3|Outcome|Lacosamide (400 mg)|Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
1065194|NCT00655551|O2|Outcome|Lacosamide (300 mg)|Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
1065195|NCT00655551|O1|Outcome|Lacosamide (200 mg)|Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
1065196|NCT00655551|E3|Reported Event|Lacosamide (400 mg)|Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
1065197|NCT00655551|E2|Reported Event|Lacosamide (300 mg)|Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
1065198|NCT00655551|E1|Reported Event|Lacosamide (200 mg)|Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
1065199|NCT00655486|B1|Baseline|Lacosamide|Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
1065200|NCT00655486|P1|Participant Flow|Lacosamide|Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
1065201|NCT00655486|O1|Outcome|Lacosamide|Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
1065202|NCT00655486|O1|Outcome|Lacosamide|Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
1065203|NCT00655486|E1|Reported Event|Lacosamide|Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
1065204|NCT00655356|B3|Baseline|Total|Total of all reporting groups
1065205|NCT00655356|B2|Baseline|Placebo|Patients treated with placebo solution
1065206|NCT00655356|B1|Baseline|Autologous Fibroblasts|Patients treated with autologous dermal fibroblasts
1065207|NCT00655356|P2|Participant Flow|Placebo|Patients treated with placebo solution
1065208|NCT00655356|P1|Participant Flow|Autologous Fibroblasts|Patients treated with autologous dermal fibroblasts
1065209|NCT00655356|O2|Outcome|Placebo|Patients treated with placebo solution.
1065210|NCT00655356|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
1065211|NCT00655356|O2|Outcome|Placebo|Patients treated with placebo solution.
1065213|NCT00655356|O2|Outcome|Placebo|Patients treated with placebo solution.
1065214|NCT00655356|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
1065215|NCT00655356|O2|Outcome|Placebo|Patients treated with placebo solution.
1065216|NCT00655356|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
1065217|NCT00655356|E2|Reported Event|Placebo|Patients treated with placebo solution.
1065218|NCT00655356|E1|Reported Event|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
1065219|NCT00655083|B3|Baseline|Total|Total of all reporting groups
1065220|NCT00655083|B2|Baseline|Nepadutant 0.5 mg/kg|Nepadutant 0.5 mg/kg
1065221|NCT00655083|B1|Baseline|Nepadutant 0.1 mg/kg|Nepadutant 0.1 mg/kg
1065222|NCT00655083|P2|Participant Flow|Nepadutant 0.5 mg/kg|Nepadutant 0.5 mg/kg
1065223|NCT00655083|P1|Participant Flow|Nepadutant 0.1 mg/kg|Nepadutant 0.1 mg/kg
1065224|NCT00655083|O2|Outcome|Nepadutant 0.5 mg/kg|Nepadutant 0.5 mg/kg
1065225|NCT00655083|O1|Outcome|Nepadutant 0.1 mg/kg|Nepadutant 0.1 mg/kg
1065226|NCT00655083|O2|Outcome|Nepadutant 0.5 mg/kg|Nepadutant 0.5 mg/kg
1065227|NCT00655083|O1|Outcome|Nepadutant 0.1 mg/kg|Nepadutant 0.1 mg/kg
1065228|NCT00655083|O2|Outcome|Nepadutant 0.5 mg/kg|Nepadutant 0.5 mg/kg
1065229|NCT00655083|O1|Outcome|Nepadutant 0.1 mg/kg|Nepadutant 0.1 mg/kg
1065230|NCT00655083|O2|Outcome|Nepadutant 0.5 mg/kg|Nepadutant 0.5 mg/kg
1065231|NCT00655083|O1|Outcome|Nepadutant 0.1 mg/kg|Nepadutant 0.1 mg/kg
1065232|NCT00655083|E2|Reported Event|Nepadutant 0.5 mg/kg|Nepadutant 0.5 mg/kg
1065233|NCT00655083|E1|Reported Event|Nepadutant 0.1 mg/kg|Nepadutant 0.1 mg/kg
1065234|NCT00654992|B3|Baseline|Total|Total of all reporting groups
1065235|NCT00654992|B2|Baseline|Placebo Group|received normal saline intraveously following induction of anesthesia
1065236|NCT00654992|B1|Baseline|Erythropoietin (EPO) Group|received 300 U/kg of erythropoietin intraveously following induction of anesthesia
1065237|NCT00654992|P2|Participant Flow|Placebo Group|received normal saline intraveously following induction of anesthesia
1065238|NCT00654992|P1|Participant Flow|Erythropoietin (EPO) Group|received 300 U/kg of erythropoietin intraveously following induction of anesthesia
1065239|NCT00654992|O2|Outcome|Placebo Group|received normal saline intraveously following induction of anesthesia
1065240|NCT00654992|O1|Outcome|Erythropoietin (EPO) Group|received 300 U/kg of erythropoietin intraveously following induction of anesthesia
1065241|NCT00654992|O2|Outcome|Placebo Group|received normal saline intraveously following induction of anesthesia
1065242|NCT00654992|O1|Outcome|Erythropoietin (EPO) Group|received 300 U/kg of erythropoietin intraveously following induction of anesthesia
1065243|NCT00654953|B4|Baseline|Total|Total of all reporting groups
1065244|NCT00654953|B3|Baseline|Active Group: Sertraline Plus Gabapentin|sertraline (200 mg/day) plus gabapentin (1,200 mg/day)
1065245|NCT00654953|B2|Baseline|Active Group: Sertraline Alone|sertraline (200 mg/day)
1065246|NCT00654953|B1|Baseline|Placebo Group|Placebo capsules
1065247|NCT00654953|P3|Participant Flow|Active Group: Sertraline Plus Gabapentin|sertraline (200 mg/day) plus gabapentin (1,200 mg/day)
1065248|NCT00654953|P2|Participant Flow|Active Group: Sertraline Alone|sertraline (200 mg/day)
1065249|NCT00654953|P1|Participant Flow|Placebo Group|Placebo capsules
1065250|NCT00654953|O3|Outcome|Sertraline Plus Gabapentin|
1065251|NCT00654953|O2|Outcome|Sertraline|
1065252|NCT00654953|O1|Outcome|Placebo|
1065253|NCT00654953|E3|Reported Event|Active Group: Sertraline Plus Gabapentin|sertraline (200 mg/day) plus gabapentin (1,200 mg/day)
1065254|NCT00654953|E2|Reported Event|Active Group: Sertraline Alone|sertraline (200 mg/day)
1065255|NCT00654953|E1|Reported Event|Placebo Group|Placebo capsules
1065256|NCT00654940|B3|Baseline|Total|Total of all reporting groups
1065257|NCT00654940|B2|Baseline|Placebo Then Pregabalin|Placebo: Day 1 in the evening, Days 2 to 14 BID, Day 15 in the morning. Pregabalin: Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing Days 2-14.
1065258|NCT00654940|B1|Baseline|Pregabalin Then Placebo|Pregabalin: Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing Days 2-14. Placebo: Day 1 in the evening, Days 2 to 14 BID, Day 15 in the morning.
1065259|NCT00654940|P2|Participant Flow|Placebo First Then Pregabalin|Placebo: Day 1 in the evening, Days 2-14 BID, Day 15 in the morning. Pregabalin: Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. Twice daily (BID) dosing on Days 2-14.
1065260|NCT00654940|P1|Participant Flow|Pregabalin First Then Placebo|Pregabalin: Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. Twice daily (BID) dosing on Days 2-14. Placebo: Day 1 in the evening, Days 2-14 BID, Day 15 in the morning.
1065261|NCT00654940|O2|Outcome|Placebo|Day 1 in the evening, Days 2-14 BID, Day 15 in the morning.
1065262|NCT00654940|O1|Outcome|Pregabalin|Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing on Days 2-14.
1065263|NCT00654940|O2|Outcome|Placebo/Pregabalin|Placebo: Day 1 in the evening, Days 2-14 BID, Day 15 in the morning. Pregabalin Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing on Days 2-14.
1065264|NCT00654940|O1|Outcome|Pregabalin/Placebo|Pregabalin Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing on Days 2-14. Placebo: Day 1 in the evening, Days 2-14 BID, Day 15 in the morning.
1065265|NCT00654940|O4|Outcome|Period 2: Pregabalin|Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing on Days 2-14.
1065266|NCT00654940|O3|Outcome|Period 2: Placebo|Day 1 in the evening, Days 2-14 BID, Day 15 in the morning.
1065267|NCT00654940|O2|Outcome|Period 1: Placebo|Day 1 in the evening, Days 2-14 BID, Day 15 in the morning.
1065521|NCT00654381|E4|Reported Event|Linagliptin 5mg (1st-2nd-Extension Stage)|
1065268|NCT00654940|O1|Outcome|Period 1: Pregabalin|Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing on Days 2-14.
1065269|NCT00654940|E2|Reported Event|Placebo|Day 1 in the evening, Days 2 to 14 BID, Day 15 in the morning.
1065270|NCT00654940|E1|Reported Event|Pregabalin|Day 1: 75 mg in the evening, Days 2 & 3: 150 mg/day, Day 4: 225 mg/day, Days 5 to 14: 300 mg/day, Day 15: 150 mg in the morning. BID dosing Days 2-14.
1065271|NCT00654927|B1|Baseline|Fampridine-SR b.i.d. (Twice Daily)|"All subjects (N=177) received 10mg b.i.d. Tablets.~(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
1065272|NCT00654927|P1|Participant Flow|Fampridine-SR b.i.d. (Twice Daily)|"All subjects (N=177) received 10mg b.i.d. Tablets.~(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
1065273|NCT00654927|O1|Outcome|Fampridine-SR b.i.d.|"All subjects (N=177) received 10mg b.i.d. Tablets.~(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
1065274|NCT00654927|O1|Outcome|Fampridine-SR b.i.d.|"All subjects (N=177) received 10mg b.i.d. Tablets.~(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
1065275|NCT00654927|O1|Outcome|Fampridine-SR b.i.d.|"All subjects (N=177) received 10mg b.i.d. Tablets.~(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
1065276|NCT00654927|O1|Outcome|Fampridine-SR b.i.d.|"All subjects (N=177) received 10mg b.i.d. Tablets.~(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
1065277|NCT00654927|O1|Outcome|Fampridine-SR b.i.d.|"All subjects (N=177) received 10mg b.i.d. Tablets.~(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
1065278|NCT00654927|E1|Reported Event|Fampridine-SR b.i.d. (Twice Daily)|"All subjects (N=177) received 10mg b.i.d. Tablets.~(N=175) subjects received 15mg b.i.d and (N=7) subjects received 20mg b.i.d at some point in the study."
1065279|NCT00654901|B5|Baseline|Total|Total of all reporting groups
1065280|NCT00654901|B4|Baseline|Infanrix Hexa™|Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.
1065281|NCT00654901|B3|Baseline|DTaP-IPV-Hep B-PRP~T Batch 3|Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
1065282|NCT00654901|B2|Baseline|DTaP-IPV-Hep B-PRP~T Batch 2|Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
1065283|NCT00654901|B1|Baseline|DTaP-IPV-Hep B-PRP~T Batch 1|Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
1065284|NCT00654901|P4|Participant Flow|Infanrix Hexa™|Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.
1065285|NCT00654901|P3|Participant Flow|DTaP-IPV-Hep B-PRP~T Batch 3|Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
1065286|NCT00654901|P2|Participant Flow|DTaP-IPV-Hep B-PRP~T Batch 2|Participants had received 3 primary doses of Batch 2 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
1065287|NCT00654901|P1|Participant Flow|DTaP-IPV-Hep B-PRP~T Batch 1|Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
1065288|NCT00654901|O4|Outcome|Infanrix Hexa™|Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.
1065289|NCT00654901|O3|Outcome|DTaP-IPV-Hep B-PRP~T Batch 3|Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
1065290|NCT00654901|O2|Outcome|DTaP-IPV-Hep B-PRP~T Batch 2|Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
1065336|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
1065291|NCT00654901|O1|Outcome|DTaP-IPV-Hep B-PRP~T Batch 1|Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
1065292|NCT00654901|O4|Outcome|Infanrix Hexa™|Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.
1065293|NCT00654901|O3|Outcome|DTaP-IPV-Hep B-PRP~T Batch 3|Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
1065294|NCT00654901|O2|Outcome|DTaP-IPV-Hep B-PRP~T Batch 2|Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
1065295|NCT00654901|O1|Outcome|DTaP-IPV-Hep B-PRP~T Batch 1|Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
1065296|NCT00654901|O4|Outcome|Infanrix Hexa™|Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.
1065297|NCT00654901|O3|Outcome|DTaP-IPV-Hep B-PRP~T Batch 3|Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
1065298|NCT00654901|O2|Outcome|DTaP-IPV-Hep B-PRP~T Batch 2|Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
1065299|NCT00654901|O1|Outcome|DTaP-IPV-Hep B-PRP~T Batch 1|Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
1065300|NCT00654901|E4|Reported Event|Infanrix Hexa™|Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.
1065301|NCT00654901|E3|Reported Event|DTaP-IPV-Hep B-PRP~T Batch 3|Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
1065302|NCT00654901|E2|Reported Event|DTaP-IPV-Hep B-PRP~T Batch 2|Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
1065303|NCT00654901|E1|Reported Event|DTaP-IPV-Hep B-PRP~T Batch 1|Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
1065304|NCT00654875|B3|Baseline|Total|Total of all reporting groups
1065305|NCT00654875|B2|Baseline|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
1065306|NCT00654875|B1|Baseline|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
1065307|NCT00654875|P2|Participant Flow|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
1065308|NCT00654875|P1|Participant Flow|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
1065337|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
1074050|NCT00629525|O1|Outcome|RAD001|RAD001 at a dose of 10 mg PO daily
1065309|NCT00654875|O2|Outcome|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
1065310|NCT00654875|O1|Outcome|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
1065311|NCT00654875|O2|Outcome|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
1065312|NCT00654875|O1|Outcome|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
1065313|NCT00654875|O2|Outcome|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
1065314|NCT00654875|O1|Outcome|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
1065315|NCT00654875|O2|Outcome|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
1065316|NCT00654875|O1|Outcome|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
1065317|NCT00654875|O2|Outcome|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
1065318|NCT00654875|O1|Outcome|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
1065319|NCT00654875|O2|Outcome|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
1065320|NCT00654875|O1|Outcome|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
1065321|NCT00654875|O2|Outcome|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
1065322|NCT00654875|O1|Outcome|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
1065323|NCT00654875|E2|Reported Event|Aliskiren 150 mg (Twice a Day)|Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
1065324|NCT00654875|E1|Reported Event|Aliskiren 300 mg (Once a Day)|Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks.
1065325|NCT00654784|B3|Baseline|Total|Total of all reporting groups
1065326|NCT00654784|B2|Baseline|Placebo|Placebo tablet: One tablet 3 times a day (Tid) with meals
1065327|NCT00654784|B1|Baseline|Idebenone 450 mg/ Day|idebenone 150 mg tablet: One tablet 3 times a day (Tid) with meals
1065328|NCT00654784|P2|Participant Flow|Placebo|Placebo tablet: One tablet 3 times a day (Tid) with meals
1065329|NCT00654784|P1|Participant Flow|Idebenone 450 mg/ Day|idebenone 150 mg tablet: One tablet 3 times a day (Tid) with meals
1065330|NCT00654784|O2|Outcome|Placebo|Placebo tablet: One tablet 3 times a day (Tid) with meals
1065331|NCT00654784|O1|Outcome|Idebenone 450 mg/ Day|idebenone 150 mg tablet: One tablet 3 times a day (Tid) with meals
1065332|NCT00654784|E2|Reported Event|Placebo|Placebo tablet: One tablet 3 times a day (Tid) with meals
1065333|NCT00654784|E1|Reported Event|Idebenone 450 mg/ Day|idebenone 150 mg tablet: One tablet 3 times a day (Tid) with meals
1065334|NCT00654745|B1|Baseline|Aml + Olm + Hctz|amlodipine (aml) + olmesartan medoxomil (olm)+ hhdrochlorothiazide (hctz) is total number enrolled. Each group is the number of participants that were titrated to that dosing regimen as per the protocol. The total number of participants of the individual groups does not (and should not) equal the total number enrolled.
1065335|NCT00654745|P1|Participant Flow|Amlodipine, Olmesartan Medoxomil, Hydrochlorothiazide|Participants receiving amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
1065450|NCT00654498|O1|Outcome|Pramipexole|
1065338|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
1065339|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
1065340|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
1065341|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
1065342|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
1065343|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
1065344|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
1065345|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
1065346|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
1065347|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
1065348|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
1065349|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
1065350|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
1065351|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
1065352|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
1065353|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
1065354|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
1065355|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
1065356|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
1065357|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
1065358|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
1065359|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
1065360|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
1065361|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
1065362|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
1065363|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
1065364|NCT00654745|O1|Outcome|Aml + Olm + Hctz|amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
1065365|NCT00654745|E7|Reported Event|Titration 5 - Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 25 mg|Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
1065366|NCT00654745|E6|Reported Event|Titration 4 Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 12.5 mg|Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
1065367|NCT00654745|E5|Reported Event|Titration 3 - Amlodipine 10 mg / Olmesartan 40 mg|Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
1065368|NCT00654745|E4|Reported Event|Titration 2 - Amlodipine 5 mg / Olmesartan 40 mg|Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
1065369|NCT00654745|E3|Reported Event|Titration 1 - Amlodipine 5 mg / Olmesartan 20 mg|Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
1065370|NCT00654745|E2|Reported Event|Start - Amlodipine 5 mg|All participants started trial on Amlodipine 5 mg.
1065371|NCT00654745|E1|Reported Event|ALL - Aml + Olm + Hctz|Summary of ALL participants receiving amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
1065372|NCT00654654|B1|Baseline|Autologous Fibroblasts|Patients received treatment with autologous fibroblasts to multiple facial regions
1065373|NCT00654654|P1|Participant Flow|Autologous Fibroblasts|Patients received treatment with autologous fibroblasts to multiple facial regions
1065374|NCT00654654|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous human fibroblasts
1065375|NCT00654654|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous human fibroblasts
1065376|NCT00654654|E1|Reported Event|Active|Patients treated with autologous human fibroblasts
1065377|NCT00654641|B3|Baseline|Total|Total of all reporting groups
1065378|NCT00654641|B2|Baseline|Standard Wound Closure|Wound closed in standard fashion utilizing subcutaneous absorb-able suture and skin staples.
1065379|NCT00654641|B1|Baseline|Negative Pressure Wound Closure|Negative Pressure wound closure utilizing wall suction and a drain placed exterior to the closed wound.
1065380|NCT00654641|P2|Participant Flow|Standard Wound Closure|Wound closed in standard fashion utilizing subcutaneous absorb-able suture and skin staples.
1065381|NCT00654641|P1|Participant Flow|Negative Pressure Wound Closure|Negative Pressure wound closure utilizing wall suction and a drain placed exterior to the closed wound.
1065382|NCT00654641|O2|Outcome|Standard Wound Closure|Wound closed in standard fashion utilizing subcutaneous absorb-able suture and skin staples.
1065383|NCT00654641|O1|Outcome|Negative Pressure Wound Closure|Negative Pressure wound closure utilizing wall suction and a drain placed exterior to the closed wound.
1065384|NCT00654641|E2|Reported Event|Standard Wound Closure|Wound closed in standard fashion utilizing subcutaneous absorb-able suture and skin staples.
1065385|NCT00654641|E1|Reported Event|Negative Pressure Wound Closure|Negative Pressure wound closure utilizing wall suction and a drain placed exterior to the closed wound.
1065386|NCT00654628|B1|Baseline|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
1065387|NCT00654628|P1|Participant Flow|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
1065388|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
1065389|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
1065390|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
1065391|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
1065392|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
1065393|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
1065394|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
1065395|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
1065396|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
1065397|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
1065398|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
1065399|NCT00654628|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
1065400|NCT00654628|E1|Reported Event|Ezetimibe/Simvastatin 10/20 mg|Ezetimibe/Simvastatin 10/20 mg tablet, once daily for the 6-week period
1065401|NCT00654511|B5|Baseline|Total|Total of all reporting groups
1065402|NCT00654511|B4|Baseline|Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV)|Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation
1065403|NCT00654511|B3|Baseline|Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV)|Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation
1065404|NCT00654511|B2|Baseline|Fentanyl 2 Micrograms/Kilogram Intravenous (IV)|Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation
1065405|NCT00654511|B1|Baseline|Fentanyl 1 Microgram/Kilogram Intravenous (IV)|Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation.
1065406|NCT00654511|P4|Participant Flow|Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV)|Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation
1065407|NCT00654511|P3|Participant Flow|Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV)|Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation
1065408|NCT00654511|P2|Participant Flow|Fentanyl 2 Micrograms/Kilogram Intravenous (IV)|Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation
1065409|NCT00654511|P1|Participant Flow|Fentanyl 1 Microgram/Kilogram Intravenous (IV)|Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation.
1065410|NCT00654511|O4|Outcome|Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV)|Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation
1065411|NCT00654511|O3|Outcome|Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV)|Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation
1065412|NCT00654511|O2|Outcome|Fentanyl 2 Micrograms/Kilogram Intravenous (IV)|Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation
1065413|NCT00654511|O1|Outcome|Fentanyl 1 Microgram/Kilogram Intravenous (IV)|Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation.
1065414|NCT00654511|O4|Outcome|Dexmedetomidine 4 Micrograms/Kilogram IV|
1065415|NCT00654511|O3|Outcome|Dexmedetomidine 2 Microgram/Kilogram IV|
1065416|NCT00654511|O2|Outcome|Fentanyl 2 Micrograms/Kilogram IV|
1065417|NCT00654511|O1|Outcome|Fentanyl 1 Microgram/Kilogram IV|
1065418|NCT00654511|E4|Reported Event|Dexmedetomidine 4 Micrograms/Kilogram Intravenous (IV)|Dexmedetomidine 4mcg/kg given immediately after endotracheal intubation
1065419|NCT00654511|E3|Reported Event|Dexmedetomidine 2 Microgram/Kilogram Intravenous (IV)|Dexmedetomidine 2mcg/kg given immediately after endotracheal intubation
1065420|NCT00654511|E2|Reported Event|Fentanyl 2 Micrograms/Kilogram Intravenous (IV)|Fentanyl 2 micrograms/kilogram IV given immediately after endotracheal intubation
1065421|NCT00654511|E1|Reported Event|Fentanyl 1 Microgram/Kilogram Intravenous (IV)|Fentanyl 1 microgram/kilogram IV given immediately after endotracheal intubation.
1065422|NCT00654498|B3|Baseline|Total|Total of all reporting groups
1065423|NCT00654498|B2|Baseline|Placebo|
1065424|NCT00654498|B1|Baseline|Pramipexole|
1065425|NCT00654498|P2|Participant Flow|Placebo|1 tablet (Pramipexole 0.125 mg matching placebo tablet), or 1 or 2 or 3 tablets (Pramipexole 0.25 mg matching placebo tablet), once daily
1065426|NCT00654498|P1|Participant Flow|Pramipexole|4 weeks of individual dose titration starting with 0.125 mg pramipexole, next dose steps 0.25 mg, 0.5 mg and 0.75 mg, fixed dose for 2 weeks, once daily
1065427|NCT00654498|O2|Outcome|Placebo|
1065428|NCT00654498|O1|Outcome|Pramipexole|
1065429|NCT00654498|O2|Outcome|Placebo|
1065430|NCT00654498|O1|Outcome|Pramipexole|
1065431|NCT00654498|O2|Outcome|Placebo|
1065432|NCT00654498|O1|Outcome|Pramipexole|
1065433|NCT00654498|O2|Outcome|Placebo|
1065434|NCT00654498|O1|Outcome|Pramipexole|
1065435|NCT00654498|O2|Outcome|Placebo|
1065436|NCT00654498|O1|Outcome|Pramipexole|
1065437|NCT00654498|O2|Outcome|Placebo|
1065438|NCT00654498|O1|Outcome|Pramipexole|
1065439|NCT00654498|O2|Outcome|Placebo|
1065440|NCT00654498|O1|Outcome|Pramipexole|
1065441|NCT00654498|O2|Outcome|Placebo|
1065442|NCT00654498|O1|Outcome|Pramipexole|
1065443|NCT00654498|O2|Outcome|Placebo|
1065444|NCT00654498|O1|Outcome|Pramipexole|
1065445|NCT00654498|O2|Outcome|Placebo|
1065446|NCT00654498|O1|Outcome|Pramipexole|
1065447|NCT00654498|O2|Outcome|Placebo|
1065448|NCT00654498|O1|Outcome|Pramipexole|
1065449|NCT00654498|O2|Outcome|Placebo|
1065454|NCT00654420|B4|Baseline|Ph II: Erlotinib|During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
1065455|NCT00654420|B3|Baseline|Ph II: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
1065456|NCT00654420|B2|Baseline|Ph I: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
1065457|NCT00654420|B1|Baseline|Ph I: Dalotuzumab 5 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
1065458|NCT00654420|P4|Participant Flow|Ph II: Erlotinib|During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
1065459|NCT00654420|P3|Participant Flow|Ph II: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
1065460|NCT00654420|P2|Participant Flow|Ph I: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
1065461|NCT00654420|P1|Participant Flow|Ph I: Dalotuzumab 5 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab intravenously (IV) at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
1065462|NCT00654420|O4|Outcome|Ph II: Erlotinib|During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
1065463|NCT00654420|O3|Outcome|Ph II: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
1065464|NCT00654420|O2|Outcome|Ph I: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
1065465|NCT00654420|O1|Outcome|Ph I: Dalotuzumab 5 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
1065466|NCT00654420|O4|Outcome|Ph II: Erlotinib|During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
1065467|NCT00654420|O3|Outcome|Ph II: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
1065468|NCT00654420|O2|Outcome|Ph I: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
1065469|NCT00654420|O1|Outcome|Ph I: Dalotuzumab 5 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
1065470|NCT00654420|O4|Outcome|Ph II: Erlotinib|During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
1065471|NCT00654420|O3|Outcome|Ph II: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
1065472|NCT00654420|O2|Outcome|Ph I: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
1065473|NCT00654420|O1|Outcome|Ph I: Dalotuzumab 5 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
1065474|NCT00654420|O4|Outcome|Ph II: Erlotinib|During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
1065475|NCT00654420|O3|Outcome|Ph II: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
1065522|NCT00654381|E3|Reported Event|Linagliptin 10mg (2nd-Extension Stage After Placebo)|
1065523|NCT00654381|E2|Reported Event|Linagliptin 5mg (2nd-Extension Stage After Placebo)|
1065524|NCT00654381|E1|Reported Event|Placebo (1st Stage)|
1065476|NCT00654420|O2|Outcome|Ph I: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
1065477|NCT00654420|O1|Outcome|Ph I: Dalotuzumab 5 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
1065478|NCT00654420|E4|Reported Event|Ph II: Erlotinib|During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
1065479|NCT00654420|E3|Reported Event|Ph II: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
1065480|NCT00654420|E2|Reported Event|Ph I: Dalotuzumab 10 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
1065481|NCT00654420|E1|Reported Event|Ph I: Dalotuzumab 5 mg/kg + Erlotinib|During the Phase I part of the study, participants received dalotuzumab IV at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
1065482|NCT00654381|B5|Baseline|Total|Total of all reporting groups
1065483|NCT00654381|B4|Baseline|Voglibose|The patients with voglibose at the start of randomised study medication
1065484|NCT00654381|B3|Baseline|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
1065485|NCT00654381|B2|Baseline|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
1065486|NCT00654381|B1|Baseline|Placebo|The patients with placebo at the start of randomised study medication
1065487|NCT00654381|P6|Participant Flow|Voglibose - Voglibose - Linagliptin 10mg|Voglibose in Stage 1 - Voglibose in Stage 2 - 10 mg in Stage 3
1065488|NCT00654381|P5|Participant Flow|Voglibose - Voglibose - Linagliptin 5mg|Voglibose in Stage 1 - Voglibose in Stage 2 - 5 mg in Stage 3
1065489|NCT00654381|P4|Participant Flow|Linagliptin 10 mg - Linagliptin 10 mg - Linagliptin 10 mg|10 mg in Stage 1 - 10 mg in Stage 2 - 10 mg in Stage 3
1065490|NCT00654381|P3|Participant Flow|Linagliptin 5mg - Linagliptin 5mg - Linagliptin 5mg|5 mg in Stage 1 - 5 mg in Stage 2 - 5 mg in Stage 3
1065491|NCT00654381|P2|Participant Flow|Placebo - Linagliptin 5mg - Linagliptin 10mg|Placebo in Stage 1 - 10 mg in Stage 2 - 10 mg in Stage 3
1065492|NCT00654381|P1|Participant Flow|Placebo - BI1356 (Linagliptin) 5mg - Linagliptin 5mg|Placebo in Stage 1 - 5 mg in Stage 2 - 5 mg in Stage 3
1065493|NCT00654381|O2|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
1065494|NCT00654381|O1|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
1065495|NCT00654381|O2|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
1065496|NCT00654381|O1|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
1065497|NCT00654381|O3|Outcome|Voglibose|The patients with voglibose at the start of randomised study medication
1065498|NCT00654381|O2|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
1065499|NCT00654381|O1|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
1065500|NCT00654381|O3|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
1065501|NCT00654381|O2|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
1065502|NCT00654381|O1|Outcome|Placebo|The patients with placebo at the start of randomised study medication
1065503|NCT00654381|O2|Outcome|Linagliptin 10mg|The patients with linagliptin 10 mg at the start of randomised study medication
1065504|NCT00654381|O1|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
1065505|NCT00654381|O3|Outcome|Voglibose|The patients with voglibose at the start of randomised study medication
1065506|NCT00654381|O2|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
1065507|NCT00654381|O1|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
1065508|NCT00654381|O3|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
1065509|NCT00654381|O2|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
1065510|NCT00654381|O1|Outcome|Placebo|The patients with placebo at the start of randomised study medication
1065511|NCT00654381|O3|Outcome|Voglibose|The patients with voglibose at the start of randomised study medication
1065512|NCT00654381|O2|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
1065513|NCT00654381|O1|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
1065514|NCT00654381|O3|Outcome|Linagliptin 10 mg|The patients with linagliptin 10 mg at the start of randomised study medication
1065515|NCT00654381|O2|Outcome|Linagliptin 5mg|The patients with linagliptin 5 mg at the start of randomised study medication
1065516|NCT00654381|O1|Outcome|Placebo|The patients with placebo at the start of randomised study medication
1065517|NCT00654381|E8|Reported Event|Linagliptin 10mg (Extension Stage After Voglibose)|
1065518|NCT00654381|E7|Reported Event|Linagliptin 5mg (Extension Stage After Voglibose)|
1065519|NCT00654381|E6|Reported Event|Voglibose (1st-2nd Stage)|
1065520|NCT00654381|E5|Reported Event|Linagliptin 10mg (1st-2nd-Extension Stage)|
1065526|NCT00654368|B3|Baseline|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
1065527|NCT00654368|B2|Baseline|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
1065528|NCT00654368|B1|Baseline|Non-randomized|Enrolled participants received treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) but discontinued prior to completing this 6 months of treatment.
1065529|NCT00654368|P3|Participant Flow|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
1065530|NCT00654368|P2|Participant Flow|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
1065531|NCT00654368|P1|Participant Flow|Non-randomized|Enrolled participants received treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) but discontinued prior to completing this 6 months of treatment.
1065532|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
1065533|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
1065534|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
1065535|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
1065536|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
1065537|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
1065538|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
1065539|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
1065540|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
1065541|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
1065542|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
1065543|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
1065544|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
1065545|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
1065692|NCT00653224|B1|Baseline|Placebo|Matching oral placebo tablet daily for 14 days
1065546|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
1065547|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
1065548|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
1065549|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
1065550|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
1065551|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
1065552|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
1065553|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
1065554|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
1065555|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
1065556|NCT00654368|O2|Outcome|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
1065557|NCT00654368|O1|Outcome|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
1065558|NCT00654368|E3|Reported Event|Etanercept + Methotrexate|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.
1065559|NCT00654368|E2|Reported Event|Etanercept Alone|After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.
1065560|NCT00654368|E1|Reported Event|Non-randomized|Enrolled participants received treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) but discontinued prior to completing this 6 months of treatment.
1065561|NCT00654355|B3|Baseline|Total|Total of all reporting groups
1065562|NCT00654355|B2|Baseline|Extra Visit Group|After Baseline, this group had an extra visit at week 1.
1065563|NCT00654355|B1|Baseline|Control Group|Group only had visits at Baseline and Week 4.
1065564|NCT00654355|P2|Participant Flow|Extra Visit Group|After Baseline, this group had an extra visit at week 1.
1065565|NCT00654355|P1|Participant Flow|Control Group|Group only had visits at Baseline and Week 4.
1065566|NCT00654355|O2|Outcome|Extra Visit Group|After Baseline, this group had an extra visit at week 1.
1065567|NCT00654355|O1|Outcome|Control Group|Group only had visits at Baseline and Week 4.
1065568|NCT00654355|O2|Outcome|Extra Visit Group|After Baseline, this group had an extra visit at week 1.
1065569|NCT00654355|O1|Outcome|Control Group|Group only had visits at Baseline and Week 4.
1065570|NCT00654355|O2|Outcome|Extra Visit Group|After Baseline, this group had an extra visit at week 1.
1065571|NCT00654355|O1|Outcome|Control Group|Group only had visits at Baseline and Week 4.
1065572|NCT00654355|E2|Reported Event|Extra Visit Group|After Baseline, this group had an extra visit at week 1.
1065573|NCT00654355|E1|Reported Event|Control Group|Group only had visits at Baseline and Week 4.
1065574|NCT00654329|B5|Baseline|Total|Total of all reporting groups
1065575|NCT00654329|B4|Baseline|Normal Saline Placebo|Normal saline placebo intranasal
1065576|NCT00654329|B3|Baseline|Fentanyl 2 Micrograms/Kilogram|Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal
1065577|NCT00654329|B2|Baseline|Dexmedetomidine 2 Micrograms/Kilogram|Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal
1065578|NCT00654329|B1|Baseline|Dexmedetomidine 1microgram/Kilogram|Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal
1065579|NCT00654329|P4|Participant Flow|Normal Saline Placebo|Normal saline placebo intranasal
1065580|NCT00654329|P3|Participant Flow|Fentanyl 2 Micrograms/Kilogram|Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal
1065581|NCT00654329|P2|Participant Flow|Dexmedetomidine 2 Micrograms/Kilogram|Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal
1065582|NCT00654329|P1|Participant Flow|Dexmedetomidine 1microgram/Kilogram|Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal
1065583|NCT00654329|O4|Outcome|Normal Saline Placebo|Normal saline placebo intranasal
1065584|NCT00654329|O3|Outcome|Fentanyl 2 Micrograms/Kilogram|Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal
1065585|NCT00654329|O2|Outcome|Dexmedetomidine 2 Micrograms/Kilogram|Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal
1065586|NCT00654329|O1|Outcome|Dexmedetomidine 1microgram/Kilogram|Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal
1065587|NCT00654329|O4|Outcome|Normal Saline Placebo|Normal saline placebo intranasal
1065588|NCT00654329|O3|Outcome|Fentanyl 2 Micrograms/Kilogram|Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal
1065589|NCT00654329|O2|Outcome|Dexmedetomidine 2 Micrograms/Kilogram|Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal
1065590|NCT00654329|O1|Outcome|Dexmedetomidine 1microgram/Kilogram|Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal
1065591|NCT00654329|E4|Reported Event|Normal Saline Placebo|Normal saline placebo intranasal
1065592|NCT00654329|E3|Reported Event|Fentanyl 2 Micrograms/Kilogram|Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal
1065593|NCT00654329|E2|Reported Event|Dexmedetomidine 2 Micrograms/Kilogram|Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal
1065594|NCT00654329|E1|Reported Event|Dexmedetomidine 1microgram/Kilogram|Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal
1065595|NCT00654186|B1|Baseline|Revlimid Oral for 21days|Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
1065596|NCT00654186|P1|Participant Flow|Revlimid Oral for 21days|Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
1065597|NCT00654186|O1|Outcome|Revlimid Oral for 21days|Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
1065598|NCT00654186|O1|Outcome|Revlimid Oral for 21days|Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
1065599|NCT00654186|O1|Outcome|Revlimid Oral for 21days|Revlimid: 25mg by mouth daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
1065600|NCT00654186|E1|Reported Event|Revlimid Orally for 21 Days|Revlimid: 25mg daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
1065601|NCT00654147|B3|Baseline|Total|Total of all reporting groups
1065602|NCT00654147|B2|Baseline|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours for 48 weeks & emtricitabine 200mg/ tenofovir 300 mg tab once daily for 48 weeks~Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
1065603|NCT00654147|B1|Baseline|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet every 12 hours for 48 & Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks~Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
1065604|NCT00654147|P2|Participant Flow|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks~Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
1065605|NCT00654147|P1|Participant Flow|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks~Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
1065606|NCT00654147|O2|Outcome|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks~Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
1065607|NCT00654147|O1|Outcome|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks~Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
1065608|NCT00654147|O2|Outcome|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks~Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
1065609|NCT00654147|O1|Outcome|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks~Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
1065610|NCT00654147|O2|Outcome|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks~Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
1065611|NCT00654147|O1|Outcome|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks~Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
1065612|NCT00654147|O2|Outcome|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks~Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
1065613|NCT00654147|O1|Outcome|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks~Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
1065614|NCT00654147|O2|Outcome|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks~Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
1065615|NCT00654147|O1|Outcome|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks~Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
1065693|NCT00653224|P2|Participant Flow|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1074097|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
1065616|NCT00654147|O2|Outcome|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks~Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
1065617|NCT00654147|O1|Outcome|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks~Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
1065618|NCT00654147|E2|Reported Event|Raltegravir & Emtricitabine/Tenofovir|"Raltegravir 400 mg tablet every 12 hours & emtricitabine 200mg/tenofovir 300 mg tab once daily for 48 weeks~Raltegravir, emtricitabine, tenofovir: 400 mg BID for 48 weeks 200 mg QD for 48 weeks 300 mg QD for 48"
1065619|NCT00654147|E1|Reported Event|Raltegravir & Lopinavir/Ritonavir|"Raltegravir 400 mg tablet and Lopinavir/ritonavir 400 mg/100 mg capsules every 12 hours for 48 weeks~Raltegravir and Lopinavir/ritonavir: 400 mg BID for 48 weeks 400mg/100 mg BID for 48 weeks"
1065620|NCT00654095|B1|Baseline|Ezetimibe + Atorvastatin|Ezetimibe 10 mg once daily + Atorvastatin 20 mg once daily
1065621|NCT00654095|P1|Participant Flow|Ezetimibe + Atorvastatin|Ezetimibe 10 mg once daily + Atorvastatin 20 mg once daily
1065622|NCT00654095|O1|Outcome|Ezetimibe + Atorvastatin|Ezetimibe 10 mg once daily + Atorvastatin 20 mg once daily
1065623|NCT00654095|E1|Reported Event|Ezetimibe+Atorvastatin|
1065624|NCT00654030|B1|Baseline|1650-G Arm|Patients receive 2 injections of 1650-G Vaccine given 4 weeks apart
1065625|NCT00654030|P1|Participant Flow|1650-G Arm|Patients receive 2 injections of 1650-G Vaccine given 4 weeks apart
1065626|NCT00654030|O1|Outcome|1650-G ARM|2 immunizations of 1650-G given 4 weeks apart
1065627|NCT00654030|E1|Reported Event|1650-G Arm|Patients receive 2 injections of 1650-G Vaccine given 4 weeks apart
1065628|NCT00654004|B3|Baseline|Total|Total of all reporting groups
1065629|NCT00654004|B2|Baseline|Controls|Subjects do not have a fatty acid oxidation disorder.
1065630|NCT00654004|B1|Baseline|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
1065631|NCT00654004|P2|Participant Flow|Controls|Subjects do not have a fatty acid oxidation disorder.
1065632|NCT00654004|P1|Participant Flow|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
1065633|NCT00654004|O2|Outcome|Controls|Subjects do not have a fatty acid oxidation disorder.
1065634|NCT00654004|O1|Outcome|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
1065635|NCT00654004|O2|Outcome|Controls|Subjects do not have a fatty acid oxidation disorder.
1065636|NCT00654004|O1|Outcome|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
1065637|NCT00654004|O2|Outcome|Controls|Subjects do not have a fatty acid oxidation disorder.
1065638|NCT00654004|O1|Outcome|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
1065639|NCT00654004|O2|Outcome|Controls|Subjects do not have a fatty acid oxidation disorder.
1065640|NCT00654004|O1|Outcome|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
1065641|NCT00654004|O2|Outcome|Controls|Subjects do not have a fatty acid oxidation disorder.
1065642|NCT00654004|O1|Outcome|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
1065643|NCT00654004|E2|Reported Event|Controls|Subjects do not have a fatty acid oxidation disorder.
1065644|NCT00654004|E1|Reported Event|Subjects|Subjects are patients with a long-chain fatty acid oxidation disorder including CPT2, VLCAD, TFP or LCHAD deficiency.
1065645|NCT00653939|B3|Baseline|Total|Total of all reporting groups
1065646|NCT00653939|B2|Baseline|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.~Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7, 14 and 21 for 6 cycles.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
1065647|NCT00653939|B1|Baseline|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg) administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
1065648|NCT00653939|P2|Participant Flow|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.~Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
1065649|NCT00653939|P1|Participant Flow|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
1065650|NCT00653939|O2|Outcome|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.~Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
1065651|NCT00653939|O1|Outcome|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
1065652|NCT00653939|O2|Outcome|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.~Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
1065653|NCT00653939|O1|Outcome|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
1065654|NCT00653939|O2|Outcome|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.~Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
1065655|NCT00653939|O1|Outcome|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
1065656|NCT00653939|O2|Outcome|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.~Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
1065657|NCT00653939|O1|Outcome|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
1065658|NCT00653939|O2|Outcome|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.~Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7, 14 and 21 for 6 cycles.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
1065659|NCT00653939|O1|Outcome|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg) administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
1065694|NCT00653224|P1|Participant Flow|Placebo|Matching oral placebo tablet daily for 14 days
1065695|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065660|NCT00653939|O2|Outcome|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.~Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
1065661|NCT00653939|O1|Outcome|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
1065662|NCT00653939|E2|Reported Event|Arm 2: Active Comparator+Fosbretabulin|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg), administered intravenously Day 1 of a 21-day cycle and fosbretabulin (60 mg/m2) on Days 7, 14, and 21 for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) on Day 1 and fosbretabulin on Days 1, 7 and 14 every 3 weeks until progression or until 12 months from randomization.~Fosbretabulin: Arm 2 only: Fosbretabulin (60 mg/m2) on Days 7,14 and 21 for 6 cycles.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
1065663|NCT00653939|E1|Reported Event|Arm 1: Chemotherapy+Bevacizumab|"Carboplatin (AUC 6), paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg)administered intravenously on Day 1 of a 21-day cycle for up to six treatment cycles. After 6 cycles, subjects who have not progressed may continue to receive bevacizumab (15 mg/kg) alone on Day 1 every 3 weeks until progression or until 12 months from randomization.~Carboplatin: Chemotherapy: Carboplatin (AUC 6) on Day 1 of each 21 day cycle for 6 cycles.~Paclitaxel: Chemotherapy: Paclitaxel (20 mg/m2) on Day 1 of each 21-day cycle for 6 cycles.~Bevacizumab: Bevacizumab (15 mg/kg) on Day 1 of each 21-day cycle for 6 cycles."
1065664|NCT00653861|B1|Baseline|Total Study Participants|Subjects who received Juvéderm with Lidocaine in one nasolabial fold and Juvéderm without Lidocaine in the other nasolabial fold.
1065665|NCT00653861|P1|Participant Flow|Total Study Participants|Subjects who received Juvederm with Lidocaine in one nasolabial fold and Juvederm without Lidocaine in the other nasolabial fold
1065666|NCT00653861|O2|Outcome|Juvéderm NLFs|Nasolabial folds on the corresponding side of the face injected with Juvederm
1065667|NCT00653861|O1|Outcome|Juvéderm Lidocaine NLFs|Nasolabial folds on one side of the face injected with the Juvederm formulation with lidocaine
1065668|NCT00653861|O1|Outcome|Total Study Participants|Subjects who received Juvéderm with Lidocaine in one nasolabial fold and Juvéderm without Lidocaine in the other nasolabial fold.
1065669|NCT00653861|O2|Outcome|Juvéderm Nasolabial Folds (NLFs)|Nasolabial folds on the corresponding side of the face injected with Juvederm
1065670|NCT00653861|O1|Outcome|Juvéderm Lidocaine Nasolabial Folds (NLFs)|Nasolabial folds on one side of the face injected with the Juvederm formulation with lidocaine
1065671|NCT00653861|E2|Reported Event|Juvéderm Nasolabial Folds (NLFs)|Nasolabial folds on the corresponding side of the face injected with Juvederm
1065672|NCT00653861|E1|Reported Event|Juvéderm Lidocaine Nasolabial Folds (NLFs)|Nasolabial folds on one side of the face injected with the Juvederm formulation with lidocaine
1065673|NCT00653523|B1|Baseline|Ezetimibe + Simvastatin|Ezetimibe 10 mg + Simvastatin 20 mg
1065674|NCT00653523|P1|Participant Flow|Ezetimibe + Simvastatin|"Ezetimibe 10 mg + Simvastatin 20 mg~level below what was specified in inclusion criterion~level >2x upper limit of normal at start of treatment~level >=3x upper limit of normal after start of treatment~did not resolve or improve after dose reduction of simvastatin"
1065675|NCT00653523|O1|Outcome|Ezetimibe + Simvastatin|Ezetimibe 10 mg + Simvastatin 20 mg
1065676|NCT00653523|E1|Reported Event|Ezetimibe+Simvastatin|
1065677|NCT00653328|B1|Baseline|Altrasentan + Doxil|Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
1065678|NCT00653328|P1|Participant Flow|Altrasentan + Doxil|Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
1065679|NCT00653328|O1|Outcome|Altrasentan + Doxil|Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
1065680|NCT00653328|O1|Outcome|Altrasentan + Doxil|Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
1065681|NCT00653328|O1|Outcome|Altrasentan + Doxil|Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
1065682|NCT00653328|O1|Outcome|Altrasentan + Doxil|Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
1065683|NCT00653328|E1|Reported Event|Altrasentan + Doxil|Atrasentan, 10 mg orally everyday continuously beginning on Day 1. Doxil. 50 mg/m2 intravenously every 28 days
1065684|NCT00653263|B1|Baseline|Methamphetamine Dependent|Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
1065685|NCT00653263|P1|Participant Flow|Methamphetamine Dependent|Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
1065686|NCT00653263|O1|Outcome|Methamphetamine Dependent|Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
1065687|NCT00653263|O1|Outcome|Methamphetamine Dependent|Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
1065688|NCT00653263|O1|Outcome|Methamphetamine Dependent|Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
1065689|NCT00653263|E1|Reported Event|Methamphetamine Dependent|Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
1065690|NCT00653224|B3|Baseline|Total|Total of all reporting groups
1065691|NCT00653224|B2|Baseline|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065696|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065697|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065698|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065699|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065700|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065701|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065702|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065703|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065704|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065705|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065706|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065707|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065708|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065709|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065710|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065711|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065712|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065713|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065714|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065715|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065716|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065717|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065718|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065719|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065720|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065721|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065722|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065723|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065724|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065725|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065726|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065727|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065728|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065729|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065730|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065731|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065732|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065733|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065734|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065735|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065736|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065737|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065738|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065739|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065740|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065741|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065742|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065743|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065744|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065745|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065746|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065747|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065748|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065749|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065750|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065751|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065752|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065753|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065754|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065755|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065756|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065757|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065758|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065759|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065760|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065761|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065762|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065763|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065764|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065765|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065766|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065767|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065768|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065769|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065770|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065771|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065772|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065773|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065774|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065775|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065776|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065777|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065778|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065779|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065780|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065781|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065782|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065783|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065784|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065785|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065786|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065787|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065788|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065789|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065790|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065791|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065792|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065793|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065794|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065795|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065796|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065797|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065798|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065799|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065800|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065801|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065802|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065803|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065804|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065805|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065806|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065807|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065808|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065809|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065810|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065811|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065812|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065813|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065814|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065815|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065816|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065817|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065818|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065819|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065820|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065821|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065822|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065823|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065824|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065825|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065826|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065827|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065828|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065829|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065830|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065831|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065832|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065833|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065834|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065835|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065836|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065837|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065838|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065839|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065840|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065841|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065842|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065843|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065844|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065845|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065846|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065847|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065848|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065849|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065850|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065851|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065852|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065853|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065854|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065855|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065856|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065857|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065858|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065859|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065860|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065861|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065862|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065863|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065864|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065865|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065866|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065867|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065868|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065869|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065870|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065871|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065872|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065873|NCT00653224|O2|Outcome|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065874|NCT00653224|O1|Outcome|Placebo|Matching oral placebo tablet daily for 14 days
1065875|NCT00653224|E2|Reported Event|Levocetirizine|Levocetirizine (LCTZ) 5 mg tablet daily for 14 days
1065876|NCT00653224|E1|Reported Event|Placebo|Matching oral placebo tablet daily for 14 days
1065877|NCT00653159|B3|Baseline|Total|Total of all reporting groups
1065878|NCT00653159|B2|Baseline|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
1065879|NCT00653159|B1|Baseline|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
1065880|NCT00653159|P2|Participant Flow|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
1065881|NCT00653159|P1|Participant Flow|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
1065882|NCT00653159|O2|Outcome|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
1065883|NCT00653159|O1|Outcome|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
1065884|NCT00653159|O2|Outcome|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
1065885|NCT00653159|O1|Outcome|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
1065886|NCT00653159|O2|Outcome|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
1065887|NCT00653159|O1|Outcome|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
1065888|NCT00653159|O2|Outcome|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
1065889|NCT00653159|O1|Outcome|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
1065890|NCT00653159|O2|Outcome|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
1065891|NCT00653159|O1|Outcome|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
1065892|NCT00653159|E2|Reported Event|Mirena IUD [LNG-IUS]|Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System
1065893|NCT00653159|E1|Reported Event|Paragard IUD [CuT380A]|Paragard intrauterine device (IUD), Copper T 380A
1065894|NCT00653133|B3|Baseline|Total|Total of all reporting groups
1065895|NCT00653133|B2|Baseline|NSPNB|Stimulator guided nerve block
1065896|NCT00653133|B1|Baseline|USPNB|ultrasound imaging guided peripheral nerve block
1065898|NCT00653133|P1|Participant Flow|USPNB|ultrasound imaging guided peripheral nerve block
1065899|NCT00653133|O2|Outcome|NSPNB|Nerve Stimulator guided peripheral nerve block
1065900|NCT00653133|O1|Outcome|USPNB|Ultrasound imaging guided peripheral nerve block
1065901|NCT00653133|E2|Reported Event|NSPNB|Stimulator guided nerve block
1065902|NCT00653133|E1|Reported Event|USPNB|ultrasound imaging guided peripheral nerve block
1065903|NCT00653068|B5|Baseline|Total|Total of all reporting groups
1065904|NCT00653068|B4|Baseline|Stratum IV|Older children with INI1 mutation only based diagnosis.
1065905|NCT00653068|B3|Baseline|Stratum III|Older children (greater than 36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
1065906|NCT00653068|B2|Baseline|Stratum II|Infants with INI1 mutation only based diagnosis (histology is not consistent with AT/RT).
1065907|NCT00653068|B1|Baseline|Stratum I|Infants (<36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
1065908|NCT00653068|P1|Participant Flow|Treatment|"Within 2-6 weeks after induction therapy or radiation therapy, patients receive high-dose carboplatin IV and high-dose thiotepa IV on days 1 and 2 and undergo autologous PBSC rescue on approximately day 4. Patients also receive G-CSF IV or SC once daily until ANC recovers.~Consolidation therapy followed by stem cell rescue repeats every 28 days for 3 courses (C) and 3D-CRT to the brain (and the spine if needed) 5 days a week for 5-6 weeks (R), the order of which depends on patient age, in the absence of disease progression or unacceptable toxicity."
1065909|NCT00653068|O1|Outcome|All Patients|Experimental
1065910|NCT00653068|O2|Outcome|Stratum III|Older children (greater than 36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
1065911|NCT00653068|O1|Outcome|Stratum I|Infants (<36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
1065912|NCT00653068|O2|Outcome|Stratum III|Older children (greater than 36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
1065913|NCT00653068|O1|Outcome|Stratum I|Infants (<36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
1065914|NCT00653068|O2|Outcome|Stratum III|Older children (greater than 36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
1065915|NCT00653068|O1|Outcome|Stratum I|Infants (<36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
1065916|NCT00653068|E2|Reported Event|Stratum III|Older children (greater than 36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
1065917|NCT00653068|E1|Reported Event|Stratum I|Infants (<36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT
1065918|NCT00652938|B4|Baseline|Total|Total of all reporting groups
1065919|NCT00652938|B3|Baseline|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065920|NCT00652938|B2|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
1065921|NCT00652938|B1|Baseline|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065922|NCT00652938|P3|Participant Flow|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065923|NCT00652938|P2|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
1065924|NCT00652938|P1|Participant Flow|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065925|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065926|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
1065927|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065928|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065929|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
1065930|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065931|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065932|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
1065933|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065934|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065935|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
1065936|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065937|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065938|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
1065939|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1066494|NCT00650806|B1|Baseline|Placebo|Each patient received matching placebo once daily for 12 weeks.
1065940|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065941|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
1065942|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065943|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065944|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
1065945|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065946|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065947|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
1065948|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065949|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065950|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
1065951|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065952|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065953|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
1065954|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065955|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065956|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
1065957|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065958|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065959|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
1065960|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065961|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065962|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
1065963|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065964|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065965|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
1065966|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065967|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065968|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
1065969|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065970|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065971|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
1065972|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065973|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065974|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
1065975|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065976|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065977|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
1065978|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065979|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065980|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
1065981|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065982|NCT00652938|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065983|NCT00652938|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
1065984|NCT00652938|O1|Outcome|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065985|NCT00652938|E3|Reported Event|Engerix Group|Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065986|NCT00652938|E2|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
1065987|NCT00652938|E1|Reported Event|Cervarix&Engerix Group|Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
1065988|NCT00652899|B1|Baseline|All Patients Enrolled|This group includes all patients consented to participate in this study.
1065989|NCT00652899|P1|Participant Flow|All Patients Enrolled|This group includes all patients consented to participate in this study.
1065990|NCT00652899|O2|Outcome|No Total Body Irradiation|This group includes patients that received chemotherapy, infusion of natural killer cells and no total body irradiation per protocol.
1065991|NCT00652899|O1|Outcome|Total Body Irradiation|This group includes patients that received chemotherapy, infusion of natural killer cells and total body irradiation per protocol.
1065992|NCT00652899|O2|Outcome|Total Body Irradiation|This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m^2 and fludarabine 25 mg/m^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 * 10^7 kg) and total body irradiation (200 Gy on Day 1 preceding natural killer cell infusion).
1065993|NCT00652899|O1|Outcome|No Total Body Irradiation|This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m^2 and fludarabine 25 mg/m^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 * 10^7 kg) and no total body irradiation.
1065994|NCT00652899|O2|Outcome|Total Body Irradiation|This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m^2 and fludarabine 25 mg/m^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 * 10^7 kg) and total body irradiation (200 Gy on Day 1 preceding natural killer cell infusion).
1065995|NCT00652899|O1|Outcome|No Total Body Irradiation|This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m^2 and fludarabine 25 mg/m^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 * 10^7 kg) and no total body irradiation.
1065996|NCT00652899|O1|Outcome|Ovarian/Fallopian Tube/Peritoneal Cancer Patients|This group includes patients with recurrent ovarian, fallopian tube or primary peritoneal cancer who received at least one dose of chemotherapy (cyclophosphamide 60 mg/m^2 and fludarabine 25 mg/m^2 for 2 doses, and aldesleukin 10 million units for 6 doses), infusion of natural killer cells (1.5-8.0 * 10^7 kg) and/or total body irradiation per protocol (200 Gy on Day 1 preceding natural killer cell infusion).
1065997|NCT00652899|E1|Reported Event|All Patients Enrolled|This group includes all patients consented to participate in this study.
1065998|NCT00652834|B1|Baseline|Kidney Transplant Recipients With GI Symptoms|"If there are negative findings on SBCE, that will be continued on MMF. No need to have second SBCE.~Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2 and Day 30.~Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2."
1065999|NCT00652834|P1|Participant Flow|Kidney Transplant Recipients With GI Symptoms|"Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2 and Day 30.~Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2."
1066000|NCT00652834|O1|Outcome|Kidney Transplant Recipients With GI Symptoms|"If there are negative findings on SBCE, that will be continued on MMF. No need to have second SBCE.~Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2 and Day 30.~Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2."
1066001|NCT00652834|E1|Reported Event|Kidney Transplant Recipients With GI Symptoms|"If there are negative findings on SBCE, that will be continued on MMF. No need to have second SBCE.~Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2 and Day 30.~Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2."
1066002|NCT00652626|B8|Baseline|Total|Total of all reporting groups
1066003|NCT00652626|B7|Baseline|Extension Phase: Severe RI|Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
1066004|NCT00652626|B6|Baseline|Extension Phase: Normal RF|Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
1066005|NCT00652626|B5|Baseline|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI; defined as creatinine clearance < 30 mL/min/1.73 m^2) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
1066006|NCT00652626|B4|Baseline|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
1066007|NCT00652626|B3|Baseline|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
1066008|NCT00652626|B2|Baseline|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
1066166|NCT00652145|O1|Outcome|Increase Dose of Mesalamine|Increase dose of mesalamine by 2.4gm per day over baseline dose for six weeks
1066009|NCT00652626|B1|Baseline|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
1066010|NCT00652626|P7|Participant Flow|Extension Phase: Severe RI|Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
1066011|NCT00652626|P6|Participant Flow|Extension Phase: Normal RF|Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
1066012|NCT00652626|P5|Participant Flow|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI; defined as creatinine clearance < 30 mL/min/1.73 m^2) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
1066013|NCT00652626|P4|Participant Flow|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
1066014|NCT00652626|P3|Participant Flow|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
1066015|NCT00652626|P2|Participant Flow|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
1066016|NCT00652626|P1|Participant Flow|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
1066017|NCT00652626|O7|Outcome|Extension Phase: Severe RI|Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
1066018|NCT00652626|O6|Outcome|Extension Phase: Normal RF|Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
1066019|NCT00652626|O5|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI; defined as creatinine clearance < 30 mL/min/1.73 m^2) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
1066020|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
1066021|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
1066022|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
1066023|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
1066024|NCT00652626|O2|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
1066025|NCT00652626|O1|Outcome|Normal RF: Azacitidine 75 mg/m^2|Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
1066026|NCT00652626|O2|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
1066027|NCT00652626|O1|Outcome|Normal RF: Azacitidine 75 mg/m^2|Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
1066028|NCT00652626|O2|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
1066029|NCT00652626|O1|Outcome|Normal RF: Azacitidine 75 mg/m^2|Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
1066030|NCT00652626|O2|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
1066031|NCT00652626|O1|Outcome|Normal RF: Azacitidine 75 mg/m^2|Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
1066032|NCT00652626|O2|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
1066033|NCT00652626|O1|Outcome|Normal RF: Azacitidine 75 mg/m^2|Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
1066034|NCT00652626|O2|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
1066035|NCT00652626|O1|Outcome|Normal RF: Azacitidine 75 mg/m^2|Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
1066036|NCT00652626|O2|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
1066037|NCT00652626|O1|Outcome|Normal RF: Azacitidine 75 mg/m^2|Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
1066038|NCT00652626|O2|Outcome|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
1066039|NCT00652626|O1|Outcome|Normal RF: Azacitidine 75 mg/m^2|Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
1066040|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
1066041|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
1066042|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
1066043|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
1066044|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
1066045|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
1066046|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
1066047|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
1066048|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
1066049|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
1066050|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
1066051|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
1066052|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
1066053|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
1066054|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
1066055|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
1066056|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
1066057|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
1066058|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
1066059|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
1066060|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
1066061|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
1066062|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
1066063|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
1066064|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
1066065|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
1066066|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
1066067|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
1066068|NCT00652626|O4|Outcome|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
1066069|NCT00652626|O3|Outcome|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
1066070|NCT00652626|O2|Outcome|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
1066071|NCT00652626|O1|Outcome|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
1066072|NCT00652626|E7|Reported Event|Extension Phase: Severe RI|Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
1066073|NCT00652626|E6|Reported Event|Extension Phase: Normal RF|Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m^2 azacitidine daily on Days 1-7 of each 28-day cycle.
1066074|NCT00652626|E5|Reported Event|Severe RI: Azacitidine 75 mg/m^2|Participants with severe renal impairment (RI; defined as creatinine clearance < 30 mL/min/1.73 m^2) received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
1066075|NCT00652626|E4|Reported Event|Azacitidine 100 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m^2 on Day 1.
1066076|NCT00652626|E3|Reported Event|Azacitidine 75 mg/m^2|Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m^2 on Days 1 to 5.
1066077|NCT00652626|E2|Reported Event|Azacitidine 50 mg/m^2|Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m^2 on Day 1.
1066078|NCT00652626|E1|Reported Event|Azacitidine 25 mg/m^2|Participants with normal renal function (defined as creatinine clearance > 80 mL/min/1.73m^2) received a single subcutaneous dose of azacitidine 25 mg/m^2 on Day 1.
1066079|NCT00652366|B6|Baseline|Total|Total of all reporting groups
1066080|NCT00652366|B5|Baseline|G+E: Early Drop Out|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 for up to 4 weeks. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for up to 4 weeks.
1066081|NCT00652366|B4|Baseline|G+E: No Rash Non-Eligible|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
1066082|NCT00652366|B3|Baseline|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
1066083|NCT00652366|B2|Baseline|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
1066084|NCT00652366|B1|Baseline|G+E: Rash ≥ Grade 2|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
1066085|NCT00652366|P5|Participant Flow|G+E: Early Drop Out|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 for up to 4 weeks. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for up to 4 weeks.
1066086|NCT00652366|P4|Participant Flow|G+E: No Rash Non-Eligibl|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
1066087|NCT00652366|P3|Participant Flow|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 milligrams per day (mg/day), PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade ≥ 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
1066088|NCT00652366|P2|Participant Flow|G+E Standard Dose: Rash Grade Less Than (<) 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
1066089|NCT00652366|P1|Participant Flow|Gemcitabine (G) Plus (+) Erlotinib (E): Rash ≥ Grade 2|Participants began a 4 week run-in period where they received gemcitabine, 1000 milligrams per square meter (mg/m^2), intravenously (IV), on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 milligrams (mg), orally (PO) as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
1066090|NCT00652366|O3|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
1066154|NCT00652314|O2|Outcome|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
1066155|NCT00652314|O1|Outcome|1 - Thrombi-gel Treatment|"Thrombi-gel treatment~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
1066156|NCT00652314|E2|Reported Event|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
1067142|NCT00649792|P1|Participant Flow|Fampridine-SR|Tablets, 10 mg, BID
1066091|NCT00652366|O2|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
1066092|NCT00652366|O1|Outcome|G+E: Rash ≥ Grade 2|Participants began a 4 week run-in period where they received gemcitabine, 1000 milligrams per square meter (mg/m^2), intravenously (IV), on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 milligrams (mg), orally (PO) as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
1066093|NCT00652366|O3|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
1066094|NCT00652366|O2|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
1066095|NCT00652366|O1|Outcome|G+E: Rash ≥ Grade 2|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
1066096|NCT00652366|O3|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
1066097|NCT00652366|O2|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
1066098|NCT00652366|O1|Outcome|G+E: Rash ≥ Grade 2|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
1066099|NCT00652366|O3|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
1066157|NCT00652314|E1|Reported Event|1 - Thrombi-gel Treatment|"Thrombi-gel treatment~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
1066158|NCT00652145|B3|Baseline|Total|Total of all reporting groups
1066159|NCT00652145|B2|Baseline|Maintain Mesalamine Dose|Participants were randomized to maintain their baseline mesalamine dose
1066167|NCT00652145|O2|Outcome|Maintain Mesalmine Dose|Maintain current mesalamine dose at 2.4 g/day
1066100|NCT00652366|O2|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
1066101|NCT00652366|O1|Outcome|G+E: Rash ≥ Grade 2|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
1066102|NCT00652366|O2|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
1066103|NCT00652366|O1|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
1066104|NCT00652366|O2|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
1066105|NCT00652366|O1|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
1066106|NCT00652366|O2|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
1066107|NCT00652366|O1|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
1066108|NCT00652366|O2|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
1066160|NCT00652145|B1|Baseline|Increase Mesalamine Dose|Participants were randomized to increase dose of mesalamine by 2.4 gm per day over their baseline dose
1066109|NCT00652366|O1|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
1066110|NCT00652366|O2|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
1066111|NCT00652366|O1|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
1066112|NCT00652366|O2|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
1066113|NCT00652366|O1|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months
1066114|NCT00652366|O2|Outcome|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
1066115|NCT00652366|O1|Outcome|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
1066116|NCT00652366|E5|Reported Event|G+E: Early Drop Out|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 for up to 4 weeks. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for up to 4 weeks.
1066117|NCT00652366|E4|Reported Event|G+E: No Rash Non-Eligible|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until the appearance of evidence of clinical progression or other toxicity leading to dose adjustments or discontinuation. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
1066161|NCT00652145|P2|Participant Flow|Maintain Baseline Mesalamine Dose|Maintain baseline mesalamine dose for six weeks
1066162|NCT00652145|P1|Participant Flow|Increase Dose of Mesalamine|Increase dose of mesalamine by 2.4gm per day over baseline dose for six weeks
1066163|NCT00652145|O2|Outcome|Maintain Baseline Mesalamine Dose|Maintain baseline mesalamine dose for six weeks
1066164|NCT00652145|O1|Outcome|Increase Dose of Mesalamine|Increase dose of mesalamine by 2.4gm per day over baseline dose for six weeks
1066165|NCT00652145|O2|Outcome|Maintain Baseline Mesalamine Dose|Maintain baseline mesalamine dose for six weeks
1066118|NCT00652366|E3|Reported Event|G+E Escalating Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive erlotinib, beginning at 150 mg/day, PO as a film-coated tablet, once daily and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a Grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal for up to 46 months. Those participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
1066119|NCT00652366|E2|Reported Event|G+E Standard Dose: Rash Grade < 2|Participants completed a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily for 4 weeks. Participants without evidence of clinical progression and who had not developed rash Grade ≥ 2 or any other toxicity leading to dose adjustments or discontinuation were randomized to receive gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression or unacceptable toxicity, or withdrawal for up to 46 months.
1066120|NCT00652366|E1|Reported Event|G+E: Rash ≥ Grade 2|Participants began a 4 week run-in period where they received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, 15, 22 until development of a rash Grade ≥ 2. Participants also received erlotinib, 100 mg, PO as a film-coated tablet, once daily until development of a rash Grade ≥ 2. Participants were not randomized to a treatment arm, but continued to receive the standard treatment of gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles, and erlotinib, 100 mg, PO as a film-coated tablet, once daily until disease progression, unacceptable toxicity, or withdrawal for up to 46 months.
1066121|NCT00652340|B3|Baseline|Total|Total of all reporting groups
1066122|NCT00652340|B2|Baseline|Placebo/Erlotinib|Patients randomized to receive placebo and erlotinib.
1066123|NCT00652340|B1|Baseline|Apricoxib/Erlotinib|Patients randomized to receive apricoxib and erlotinib.
1066124|NCT00652340|P2|Participant Flow|Placebo/Erlotinib|Patients randomized to receive placebo and erlotinib.
1066125|NCT00652340|P1|Participant Flow|Apricoxib/Erlotinib|Patients randomized to receive apricoxib and erlotinib.
1066126|NCT00652340|O2|Outcome|Placebo/Erlotinib|Patients randomized to receive placebo and erlotinib.
1066127|NCT00652340|O1|Outcome|Apricoxib/Erlotinib|Patients randomized to receive apricoxib and erlotinib.
1066128|NCT00652340|O2|Outcome|Placebo/Erlotinib|Patients randomized to receive placebo and erlotinib.
1066129|NCT00652340|O1|Outcome|Apricoxib/Erlotinib|Patients randomized to receive apricoxib and erlotinib.
1066130|NCT00652340|E2|Reported Event|Placebo/Erlotinib|Patients randomized to receive placebo and erlotinib.
1066131|NCT00652340|E1|Reported Event|Apricoxib/Erlotinib|Patients randomized to receive apricoxib and erlotinib.
1066132|NCT00652327|B3|Baseline|Total|Total of all reporting groups
1066133|NCT00652327|B2|Baseline|Double Statin|Double the dose of daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
1066134|NCT00652327|B1|Baseline|Ezetimibe + Statin|Once daily 10-mg ezetimibe tablet added to daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
1066135|NCT00652327|P2|Participant Flow|Double Statin|Double the dose of daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
1066136|NCT00652327|P1|Participant Flow|Ezetimibe + Statin|Once daily 10-mg ezetimibe tablet added to daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
1066137|NCT00652327|O2|Outcome|Double Statin|Double the dose of daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
1066138|NCT00652327|O1|Outcome|Ezetimibe + Statin|Once daily 10-mg ezetimibe tablet added to daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
1066139|NCT00652327|E2|Reported Event|Double Statin|Double the dose of daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
1066140|NCT00652327|E1|Reported Event|Ezetimibe + Statin|Once daily 10-mg ezetimibe tablet added to daily ongoing statin treatment (simvastatin 20 mg or atorvastatin 10 mg or pravastatin 20 mg) for 8 weeks
1066141|NCT00652314|B3|Baseline|Total|Total of all reporting groups
1066142|NCT00652314|B2|Baseline|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
1066143|NCT00652314|B1|Baseline|1 - Thrombi-gel Treatment|"Thrombi-gel treatment~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
1066144|NCT00652314|P2|Participant Flow|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
1066145|NCT00652314|P1|Participant Flow|1 - Thrombi-gel Treatment|"Thrombi-gel treatment~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
1066146|NCT00652314|O2|Outcome|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
1066147|NCT00652314|O1|Outcome|1 - Thrombi-gel Treatment|"Thrombi-gel treatment~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
1066148|NCT00652314|O2|Outcome|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
1066149|NCT00652314|O1|Outcome|1 - Thrombi-gel Treatment|"Thrombi-gel treatment~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
1066150|NCT00652314|O2|Outcome|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
1066151|NCT00652314|O1|Outcome|1 - Thrombi-gel Treatment|"Thrombi-gel treatment~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
1066152|NCT00652314|O2|Outcome|2 - Gelatin Sponge (Gelfoam) Plus Thrombin|"Gelatin Sponge (Gelfoam) plus thrombin~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
1066153|NCT00652314|O1|Outcome|1 - Thrombi-gel Treatment|"Thrombi-gel treatment~Thrombi-Gel: Applicaton of Hemostatic product during surgery"
1066168|NCT00652145|O1|Outcome|Increase Mesalamine Dose by 2.4g/Day|"Increase dose of mesalamine by 2.4 gm per day~mesalamine: Increase dose by 2.4gm per day over baseline dose"
1066169|NCT00652145|E2|Reported Event|Maintain Baseline Mesalamine Dose|Maintain baseline mesalamine dose for six weeks
1066170|NCT00652145|E1|Reported Event|Increase Dose of Mesalamine|Increase dose of mesalamine by 2.4gm per day over baseline dose for six weeks
1066171|NCT00652093|B7|Baseline|Total|Total of all reporting groups
1066172|NCT00652093|B6|Baseline|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
1066173|NCT00652093|B5|Baseline|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
1066174|NCT00652093|B4|Baseline|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
1066175|NCT00652093|B3|Baseline|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
1066176|NCT00652093|B2|Baseline|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
1066177|NCT00652093|B1|Baseline|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
1066178|NCT00652093|P6|Participant Flow|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
1066179|NCT00652093|P5|Participant Flow|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
1066180|NCT00652093|P4|Participant Flow|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
1066181|NCT00652093|P3|Participant Flow|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
1066182|NCT00652093|P2|Participant Flow|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
1066183|NCT00652093|P1|Participant Flow|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
1066184|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
1066185|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
1066186|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
1066187|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
1066188|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
1066189|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
1066190|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
1067143|NCT00649792|O1|Outcome|Fampridine-SR|Tablets, 10 mg, BID
1066191|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
1066192|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
1066193|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
1066194|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
1066195|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
1066196|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
1066197|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
1066198|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
1066199|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
1066200|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
1066201|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
1066202|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
1066203|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
1066204|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
1066205|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
1066206|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
1066207|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
1066208|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
1066209|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
1066210|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
1066211|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
1066212|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
1066213|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
1066214|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
1066215|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
1066216|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
1066217|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
1066218|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
1066219|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
1066220|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
1066221|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
1066222|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
1066223|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
1066224|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
1066225|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
1066226|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
1066227|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
1066228|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
1066229|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
1066230|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
1066231|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
1066232|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
1066233|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
1066234|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
1066235|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
1066236|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
1066237|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
1066238|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
1066239|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
1066240|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
1066241|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
1066242|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
1066243|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
1066244|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
1066245|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
1066246|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
1066247|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
1066248|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
1066249|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
1066250|NCT00652093|O6|Outcome|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
1066251|NCT00652093|O5|Outcome|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
1066252|NCT00652093|O4|Outcome|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
1066253|NCT00652093|O3|Outcome|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
1066254|NCT00652093|O2|Outcome|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
1066255|NCT00652093|O1|Outcome|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
1066256|NCT00652093|E6|Reported Event|Darvocet Then Placebo Then Opana|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
1066257|NCT00652093|E5|Reported Event|Darvocet Then Opana Then Placebo|Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
1066258|NCT00652093|E4|Reported Event|Placebo Then Darvocet Then Opana|Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
1066259|NCT00652093|E3|Reported Event|Placebo Then Opana Then Darvocet|Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
1066260|NCT00652093|E2|Reported Event|Opana Then Placebo Then Darvocet|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
1066261|NCT00652093|E1|Reported Event|Opana Then Darvocet Then Placebo|Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
1066262|NCT00652028|B5|Baseline|Total|Total of all reporting groups
1066263|NCT00652028|B4|Baseline|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
1066264|NCT00652028|B3|Baseline|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
1066265|NCT00652028|B2|Baseline|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
1066266|NCT00652028|B1|Baseline|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
1066267|NCT00652028|P4|Participant Flow|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
1066268|NCT00652028|P3|Participant Flow|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
1066269|NCT00652028|P2|Participant Flow|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
1066270|NCT00652028|P1|Participant Flow|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
1066271|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
1066272|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
1066273|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
1066274|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
1066275|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
1066276|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
1066277|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
1066278|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
1066279|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
1066280|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
1066281|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
1066282|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
1066283|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
1066284|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
1066285|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
1066377|NCT00651313|O1|Outcome|Lidocaine 10%|Crossover Study Sequence 1 = 10% Lidocaine Gel to Placebo Gel Sequence 2 = Placebo Gel to 10% Lidocaine Gel
1066286|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
1066287|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
1066288|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
1066289|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
1066290|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
1066291|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
1066292|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
1066293|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
1066294|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
1066295|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
1066296|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
1066297|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
1066298|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
1066299|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
1066300|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
1066301|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
1066302|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
1066303|NCT00652028|O4|Outcome|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
1066304|NCT00652028|O3|Outcome|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
1066305|NCT00652028|O2|Outcome|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
1066306|NCT00652028|O1|Outcome|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
1066307|NCT00652028|E4|Reported Event|Dose Level 4|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
1066308|NCT00652028|E3|Reported Event|Dose Level 3|Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
1066309|NCT00652028|E2|Reported Event|Dose Level 2|Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
1066310|NCT00652028|E1|Reported Event|Dose Level 1|Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
1066311|NCT00651924|B3|Baseline|Total|Total of all reporting groups
1066312|NCT00651924|B2|Baseline|Phase 2|Pilot IVR-based Cognitive-behavior therapy: Standard cognitive-behavior therapy for chronic pain management using Interactive Voice Response (IVR) compatible materials and handouts
1066313|NCT00651924|B1|Baseline|Phase 1|Review the materials and provide feedback regarding how understandable, engaging, and informative the materials are.
1066314|NCT00651924|P2|Participant Flow|Phase 2|Undergo IVR-based Cognitive Behavioral Therapy treatment using the new materials.
1066315|NCT00651924|P1|Participant Flow|Phase 1|Review of materials and provide feedback regarding how understandable, engaging, and informative the materials are. Revisions will be made based on this feedback.
1066316|NCT00651924|O2|Outcome|Phase 2|Pilot IVR-based CBT treatment
1066317|NCT00651924|O1|Outcome|Phase 1|Qualitative interviews
1066318|NCT00651924|E2|Reported Event|Phase 2|Pilot the newly developed materials during a 10-week course of cognitive behavioral therapy for chronic pain
1066319|NCT00651924|E1|Reported Event|Phase 1|Review of newly created materials and provide feedback regarding how understandable, engaging, and informative the materials are.
1066320|NCT00651820|B1|Baseline|Rate of Wound Closure Collagenase Santyl vs. Vehicle|Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
1066321|NCT00651820|P1|Participant Flow|Rate of Wound Closure Collagenase Santyl vs. Vehicle|Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
1066322|NCT00651820|O2|Outcome|Vehicle Rate of Wound Closure|Dermatome-induced skin wounds treated with Vehicle alone. Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
1066323|NCT00651820|O1|Outcome|Collagenase Santyl Rate of Wound Closure|Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
1066378|NCT00651313|E2|Reported Event|Placebo|Placebo vaginal gel
1066324|NCT00651820|O2|Outcome|Vehicle Rate to Complete Wound Healing|Dermatome-induced skin wounds treated with Vehicle alone. Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
1066325|NCT00651820|O1|Outcome|Collagenase Santyl Rate of Wound Closure|Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
1066326|NCT00651820|E1|Reported Event|Rate of Wound Closure Collagenase Santyl vs. Vehicle|Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.
1066327|NCT00651755|B1|Baseline|Entire Study Population|Participants randomized to Aprepitant or control (Standard of Care) in Cycle 1 crossover for different treatment in Cycle 2.
1066328|NCT00651755|P2|Participant Flow|First No Aprepritant Cycle 1, Then Aprepitant Cycle 2|First No Aprepitant in Cycle 1, then Aprepitant 125 mg oral (PO) Day 1 of Cycle 2 followed by 80 mg PO Daily Days 2-3 with CHOP (steroid in CHOP) or R-CHOP plus Rituximab 375 mg/m^2 intravenous Day 1. CHOP or R-CHOP chemotherapy: (1) bolus or 48-hour infusion CHOP [cyclophosphamide 750 mg/m^2 IV Day 1, doxorubicin 25 mg/m^2/day IV given bolus or over 48 hours continuous infusion Days 1-2, vincristine 2 mg IV Day 1, prednisone PO 100 mg * 5 days]; or (2) Bolus or 48-hour infusion R-CHOP [Rituximab 375 mg/m^2 on Day 1 + CHOP as above].
1066329|NCT00651755|P1|Participant Flow|First Aprepitant Cycle 1 Then No Aprepitant Cycle 2|"First Aprepitant with CHOP or R-CHOP (CHOP plus Rituximab 375 mg/m^2 intravenous Day 1) then No Aprepitant in Cycle 2.~Aprepitant 125 mg oral (PO) Day 1 of Cycle 1 followed by 80 mg PO Daily Days 2-3 with CHOP (steroid in CHOP) or R-CHOP plus Rituximab 375 mg/m^2 intravenous Day 1. CHOP or R-CHOP chemotherapy: (1) bolus or 48-hour infusion CHOP [cyclophosphamide 750 mg/m^2 IV Day 1, doxorubicin 25 mg/m^2/day IV given bolus or over 48 hours continuous infusion Days 1-2, vincristine 2 mg IV Day 1, prednisone PO 100 mg * 5 days]; or (2) Bolus or 48-hour infusion R-CHOP [Rituximab 375 mg/m^2 on Day 1 + CHOP as above]."
1066330|NCT00651755|O2|Outcome|Control|Crossover study where participants received Standard of care in cycle 1 or cycle 2.
1066331|NCT00651755|O1|Outcome|Aprepitant|Crossover study where participants received Aprepitant 125 mg oral (PO) Day 1 in Cycle 1 and received standard of care in Cycle 2. Or participants received no Aprepitant in Cycle 1, Aprepitant 125 mg oral (PO) Day 1 in Cycle 2.
1066332|NCT00651755|O2|Outcome|Control|Crossover study where participants received Standard of care in cycle 1 or cycle 2.
1066333|NCT00651755|O1|Outcome|Aprepitant|Crossover study where participants received Aprepitant 125 mg oral (PO) Day 1 in Cycle 1 and received standard of care in Cycle 2. Or participants received no Aprepitant in Cycle 1, Aprepitant 125 mg oral (PO) Day 1 in Cycle 2.
1066334|NCT00651755|O2|Outcome|Control|Crossover study where participants received Standard of care in cycle 1 or cycle 2.
1066335|NCT00651755|O1|Outcome|Aprepitant|Crossover study where participants received Aprepitant 125 mg oral (PO) Day 1 in Cycle 1 and received standard of care in Cycle 2. Or participants received no Aprepitant in Cycle 1, Aprepitant 125 mg oral (PO) Day 1 in Cycle 2.
1066336|NCT00651755|O2|Outcome|Control|Crossover study where participants received Standard of care in cycle 1 or cycle 2.
1066337|NCT00651755|O1|Outcome|Aprepitant|Crossover study where participants received Aprepitant 125 mg oral (PO) Day 1 in Cycle 1 and received standard of care in Cycle 2. Or participants received no Aprepitant in Cycle 1, Aprepitant 125 mg oral (PO) Day 1 in Cycle 2.
1066338|NCT00651755|O2|Outcome|Control|Crossover study where participants received Standard of care in cycle 1 or cycle 2.
1066339|NCT00651755|O1|Outcome|Aprepitant|Crossover study where participants received Aprepitant 125 mg oral (PO) Day 1 in Cycle 1 and received standard of care in Cycle 2. Or participants received no Aprepitant in Cycle 1, Aprepitant 125 mg oral (PO) Day 1 in Cycle 2.
1066340|NCT00651755|O2|Outcome|Control Group|Crossover study where participants received Standard of care in cycle 1 or cycle 2.
1066341|NCT00651755|O1|Outcome|Aprepitant|Crossover study where participants received Aprepitant 125 mg oral (PO) Day 1 in Cycle 1 and received standard of care in Cycle 2. Or participants received no Aprepitant in Cycle 1, Aprepitant 125 mg oral (PO) Day 1 in Cycle 2.
1066342|NCT00651755|E2|Reported Event|Control|Standard of Care
1066343|NCT00651755|E1|Reported Event|Aprepitant|Aprepitant 125 mg oral (PO) Day 1 (Cycle 1 or Cycle 2) to include treated study population.
1066344|NCT00651625|B3|Baseline|Total|Total of all reporting groups
1066345|NCT00651625|B2|Baseline|2RPD Syring|Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
1066346|NCT00651625|B1|Baseline|1Conventional Syringe|The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
1066347|NCT00651625|P2|Participant Flow|2RPD Syring|Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
1067144|NCT00649792|O1|Outcome|Fampridine-SR|Tablets, 10 mg, BID
1066348|NCT00651625|P1|Participant Flow|1Conventional Syringe|The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
1066349|NCT00651625|O2|Outcome|2RPD Syringe|Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
1066350|NCT00651625|O1|Outcome|1Conventional Syringe|The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
1066351|NCT00651625|O2|Outcome|2RPD Syringe|Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
1066352|NCT00651625|O1|Outcome|1Conventional Syringe|The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
1066353|NCT00651625|O2|Outcome|2RPD Syringe|Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
1066354|NCT00651625|O1|Outcome|1Conventional Syringe|The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
1066355|NCT00651625|O2|Outcome|2RPD Syringe|Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
1066356|NCT00651625|O1|Outcome|1Conventional Syringe|The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
1066379|NCT00651313|E1|Reported Event|Active|Lidocaine 10% (150mg) vaginal gel
1066380|NCT00651261|B3|Baseline|Total|Total of all reporting groups
1066492|NCT00650806|B3|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
1066493|NCT00650806|B2|Baseline|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
1066357|NCT00651625|E2|Reported Event|2RPD Syring|Conventional Syringe - The conventional syringe is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) are determined). The comparison is with the same procedure performed with the RPD syringe with and without ultrasound. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
1066358|NCT00651625|E1|Reported Event|1Conventional Syringe|The intervention is the use of the reciprocating procedure device (RPD) with and without ultrasound guidance in a syringe and needle procedure in comparison to a conventional syringe. The RPD is used to performed the syringe and needle procedure and outcome (effect of procedure (pain scores at 2 weeks and 6 months compared to preprocedural pain scores), and procedural pain (pain scores during procedure) - are determined. Thus, pain scores as measured by the standard 10 cm Visual Analogue Pain Score are used to primary outcome as is standard in the field of pain. These scores from the two treatment arms are then compared statistically with each other by appropriate methods. It is hypothesized that the RPD will be more effective (reduced pain scores at 2 weeks and 6 months) and less pain (reduced procedural pain scores) compared to the same procedure with the conventional syringe.
1066359|NCT00651482|B1|Baseline|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)~Everolimus~Bevacizumab"
1066360|NCT00651482|P1|Participant Flow|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)~Everolimus~Bevacizumab"
1066361|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
1066362|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
1066363|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
1066364|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
1066365|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
1066366|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
1066367|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
1066368|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)~Everolimus~Bevacizumab"
1066369|NCT00651482|O1|Outcome|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
1066370|NCT00651482|E1|Reported Event|Bevacizumab + RAD001 (Everolimus)|"Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles~Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)~Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)"
1066371|NCT00651313|B3|Baseline|Total|Total of all reporting groups
1066372|NCT00651313|B2|Baseline|Placebo|Placebo vaginal gel
1066373|NCT00651313|B1|Baseline|Active|Lidocaine 10% (150mg) vaginal gel
1066374|NCT00651313|P2|Participant Flow|Placebo|Placebo vaginal gel
1066375|NCT00651313|P1|Participant Flow|Active|Lidocaine 10% (150mg) vaginal gel
1066376|NCT00651313|O2|Outcome|Placebo Gel|Crossover Study Sequence 1 = 10% Lidocaine Gel to Placebo Gel Sequence 2 = Placebo Gel to 10% Lidocaine Gel
1066381|NCT00651261|B2|Baseline|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
1066382|NCT00651261|B1|Baseline|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
1066383|NCT00651261|P2|Participant Flow|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
1066384|NCT00651261|P1|Participant Flow|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
1066385|NCT00651261|O2|Outcome|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
1066386|NCT00651261|O1|Outcome|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
1066387|NCT00651261|O2|Outcome|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
1066388|NCT00651261|O1|Outcome|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
1066389|NCT00651261|O2|Outcome|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
1066390|NCT00651261|O1|Outcome|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
1066391|NCT00651261|O2|Outcome|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
1066392|NCT00651261|O1|Outcome|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
1066393|NCT00651261|O2|Outcome|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
1066394|NCT00651261|O1|Outcome|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
1066395|NCT00651261|E2|Reported Event|Induction and Consolidation Chemotherapy Plus Placebo|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.
1066396|NCT00651261|E1|Reported Event|Induction and Consolidation Chemotherapy Plus Midostaurin|Patients will receive daunorubicin 60 mg/m^2 by IV push days 1-3 plus cytarabine 200 mg/m^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m^2) days 1, 3, & 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.
1066397|NCT00651183|B3|Baseline|Total|Total of all reporting groups
1066398|NCT00651183|B2|Baseline|Advanced PD|Advanced Parkinson's Disease (PD) patients
1066399|NCT00651183|B1|Baseline|Early PD|Early Parkinson's Disease (PD) patients
1066400|NCT00651183|P2|Participant Flow|Advanced PD|Advanced Parkinson's Disease (PD) patients
1066401|NCT00651183|P1|Participant Flow|Early (PD)|Early Parkinson's Disease (PD) patients
1066402|NCT00651183|O2|Outcome|Advanced PD|Advanced Parkinson's Disease (PD) patients
1066403|NCT00651183|O1|Outcome|Early PD|Early Parkinson's Disease (PD) patients
1066404|NCT00651183|O2|Outcome|Advanced PD|Advanced Parkinson's Disease (PD) patients
1066405|NCT00651183|O1|Outcome|Early PD|Early Parkinson's Disease (PD) patients
1066406|NCT00651183|O2|Outcome|Advanced PD|Advanced Parkinson's Disease (PD) patients
1066407|NCT00651183|O1|Outcome|Early PD|Early Parkinson's Disease (PD) patients
1066408|NCT00651183|O2|Outcome|Advanced PD|Advanced Parkinson's Disease (PD) patients
1066409|NCT00651183|O1|Outcome|Early PD|Early Parkinson's Disease (PD) patients
1066410|NCT00651183|E2|Reported Event|Advanced PD|Advanced Parkinson's Disease (PD) patients
1066411|NCT00651183|E1|Reported Event|Early PD|Early Parkinson's Disease (PD) patients
1066412|NCT00651157|B1|Baseline|Treatment (Viral Therapy)|Patients receive wild-type reovirus (Reolysin®) IV administered at a dose of 3 x 10^10 TCID50/day in 250 mL 0.9% sodium chloride infused intravenously over 60 minutes daily on days 1-5 of each 28-day cycle. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1066413|NCT00651157|P1|Participant Flow|Treatment (Viral Therapy)|Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1066414|NCT00651157|O1|Outcome|Treatment (Viral Therapy)|Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1066415|NCT00651157|O1|Outcome|Treatment (Viral Therapy)|Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1066416|NCT00651157|O1|Outcome|Treatment (Viral Therapy)|Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1066417|NCT00651157|E1|Reported Event|Treatment (Viral Therapy)|Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1066418|NCT00651118|B5|Baseline|Total|Total of all reporting groups
1066419|NCT00651118|B4|Baseline|Placebo|placebo nasal spray
1066420|NCT00651118|B3|Baseline|Azelastine HCl|azelastine HCl nasal spray nasal spray
1066421|NCT00651118|B2|Baseline|Fluticasone Propionate|fluticasone propionate nasal spray
1066422|NCT00651118|B1|Baseline|MP29-02|MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray
1066423|NCT00651118|P4|Participant Flow|Placebo|placebo nasal spray
1066424|NCT00651118|P3|Participant Flow|Azelastine HCl|azelastine HCl nasal spray nasal spray
1066425|NCT00651118|P2|Participant Flow|Fluticasone Propionate|fluticasone propionate nasal spray
1066426|NCT00651118|P1|Participant Flow|MP29-02|MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray
1066427|NCT00651118|O4|Outcome|Placebo|placebo nasal spray
1066428|NCT00651118|O3|Outcome|Azelastine HCl|azelastine HCl nasal spray nasal spray
1066429|NCT00651118|O2|Outcome|Fluticasone Propionate|fluticasone propionate nasal spray
1066430|NCT00651118|O1|Outcome|MP29-02|MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray
1066431|NCT00651118|O4|Outcome|Placebo|Placebo nasal spray
1066432|NCT00651118|O3|Outcome|Azelastine HCl|azelastine HCl nasal spray
1066433|NCT00651118|O2|Outcome|Fluticasone Propionate|fluticasone propionate nasal spray
1066434|NCT00651118|O1|Outcome|MP29-02|fluticasone propionate 50 mcg / azelastine HCl 137 mcg nasal spray
1066435|NCT00651118|O4|Outcome|Placebo|placebo nasal spray
1066436|NCT00651118|O3|Outcome|Azelastine HCl|azelastine HCl nasal spray nasal spray
1066437|NCT00651118|O2|Outcome|Fluticasone Propionate|fluticasone propionate nasal spray
1066438|NCT00651118|O1|Outcome|MP29-02|MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray
1066439|NCT00651118|E4|Reported Event|Placebo|placebo nasal spray
1066440|NCT00651118|E3|Reported Event|Azelastine HCl|azelastine HCl nasal spray nasal spray
1066441|NCT00651118|E2|Reported Event|Fluticasone Propionate|fluticasone propionate nasal spray
1066442|NCT00651118|E1|Reported Event|MP29-02|MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray
1066443|NCT00651040|B3|Baseline|Total|Total of all reporting groups
1066489|NCT00650845|E1|Reported Event|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration before the MRI
1066490|NCT00650806|B5|Baseline|Total|Total of all reporting groups
1066491|NCT00650806|B4|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
1066444|NCT00651040|B2|Baseline|2Prednison MTX|"MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.~Methotrexate: MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose."
1066445|NCT00651040|B1|Baseline|1Prednison|"Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms.~ARM 1 has only Prednisone~Prednisone: Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms"
1066446|NCT00651040|P2|Participant Flow|2Prednison MTX|"MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.~Methotrexate: MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose."
1066447|NCT00651040|P1|Participant Flow|1Prednison|"Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms.~ARM 1 has only Prednisone~Prednisone: Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms"
1066448|NCT00651040|O2|Outcome|Prednison Methotrexate 2|"MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.~Methotrexate: MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose."
1066449|NCT00651040|O1|Outcome|Prednison1|"Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms.~ARM 1 has only Prednisone~Prednisone: Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms"
1066450|NCT00651040|E2|Reported Event|2 Prednison Methotrexate|"MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.~Methotrexate: MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose."
1066451|NCT00651040|E1|Reported Event|1 Prednison|"Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms.~ARM 1 has only Prednisone~Prednisone: Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms"
1066452|NCT00650858|B4|Baseline|Total|Total of all reporting groups
1066453|NCT00650858|B3|Baseline|1.0 mg Rt-PA q8h|Stage 2 (Dose Optimization)
1066454|NCT00650858|B2|Baseline|1.0 mg Rt-PA q12h|Stage 1 (Dose Finding)
1066455|NCT00650858|B1|Baseline|0.3 mg Rt-PA q12h|Stage 1 (Dose Finding)
1066456|NCT00650858|P3|Participant Flow|1.0 mg Rt-PA q8h|Stage 2 (Dose Optimization)
1066457|NCT00650858|P2|Participant Flow|1.0 mg Rt-PA q12h|Stage 1 (Dose Finding)
1066458|NCT00650858|P1|Participant Flow|0.3 mg Rt-PA q12h|Stage 1 (Dose Finding)
1066459|NCT00650858|O3|Outcome|1.0 mg Rt-PA q8h|Stage 2 (Dose Optimization)
1066460|NCT00650858|O2|Outcome|1.0 mg Rt-PA q12h|Stage 1 (Dose Finding)
1066461|NCT00650858|O1|Outcome|0.3 mg Rt-PA q12h|Stage 1 (Dose Finding)
1066462|NCT00650858|O3|Outcome|1.0 mg Rt-PA q8h|Stage 2 (Dose Optimization)
1066463|NCT00650858|O2|Outcome|1.0 mg Rt-PA q12h|Stage 1 (Dose Finding)
1066464|NCT00650858|O1|Outcome|0.3 mg Rt-PA q12h|Stage 1 (Dose Finding)
1066465|NCT00650858|O3|Outcome|1.0 mg Rt-PA q8h|Stage 2 (Dose Optimization)
1066466|NCT00650858|O2|Outcome|1.0 mg Rt-PA q12h|Stage 1 (Dose Finding)
1066467|NCT00650858|O1|Outcome|0.3 mg Rt-PA q12h|Stage 1 (Dose Finding)
1066468|NCT00650858|E3|Reported Event|1.0 mg Rt-PA q8h|Stage 2 (Dose Optimization)
1066469|NCT00650858|E2|Reported Event|1.0 mg Rt-PA q12h|Stage 1 (Dose Finding)
1066470|NCT00650858|E1|Reported Event|0.3 mg Rt-PA q12h|Stage 1 (Dose Finding)
1066471|NCT00650845|B3|Baseline|Total|Total of all reporting groups
1066472|NCT00650845|B2|Baseline|Non-enhanced MRI|non-enhanced MRI: non injected MRI
1066473|NCT00650845|B1|Baseline|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration before the MRI
1066474|NCT00650845|P2|Participant Flow|Non-enhanced MRI|non-enhanced MRI: non injected MRI
1066475|NCT00650845|P1|Participant Flow|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration
1066476|NCT00650845|O2|Outcome|Non-enhanced MRI|non-enhanced MRI: non injected MRI
1066477|NCT00650845|O1|Outcome|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration
1066478|NCT00650845|O2|Outcome|Non-enhanced MRI|non-enhanced MRI: non injected MRI
1066479|NCT00650845|O1|Outcome|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration
1066480|NCT00650845|O2|Outcome|Non-enhanced MRI|non-enhanced MRI: non injected MRI
1066481|NCT00650845|O1|Outcome|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration
1066482|NCT00650845|O2|Outcome|Non-enhanced MRI|non-enhanced MRI: non injected MRI
1066483|NCT00650845|O1|Outcome|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration
1066484|NCT00650845|O2|Outcome|Non-enhanced MRI|non-enhanced MRI: non injected MRI
1066485|NCT00650845|O1|Outcome|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration before the MRI
1066486|NCT00650845|O2|Outcome|Non-enhanced MRI|non-enhanced MRI: non injected MRI
1066487|NCT00650845|O1|Outcome|Dotarem®-Enhanced MRI|Dotarem®: Single IV administration before the MRI
1066488|NCT00650845|E2|Reported Event|Non-enhanced MRI|non-enhanced MRI: non injected MRI
1066495|NCT00650806|P4|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canaliflozin (JNJ-28431754) once daily for 12 weeks.
1066496|NCT00650806|P3|Participant Flow|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
1066497|NCT00650806|P2|Participant Flow|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
1066498|NCT00650806|P1|Participant Flow|Placebo|Each patient received matching placebo once daily for 12 weeks.
1066499|NCT00650806|O4|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
1066500|NCT00650806|O3|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
1066501|NCT00650806|O2|Outcome|Canaglifozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
1066502|NCT00650806|O1|Outcome|Placebo|Each patient received matching placebo once daily for 12 weeks.
1066503|NCT00650806|O4|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
1066504|NCT00650806|O3|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
1066505|NCT00650806|O2|Outcome|Canaglifozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
1066506|NCT00650806|O1|Outcome|Placebo|Each patient received matching placebo once daily for 12 weeks.
1066507|NCT00650806|O4|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
1066508|NCT00650806|O3|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
1066509|NCT00650806|O2|Outcome|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
1066510|NCT00650806|O1|Outcome|Placebo|Each patient received matching placebo once daily for 12 weeks.
1066511|NCT00650806|O4|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
1066512|NCT00650806|O3|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
1066513|NCT00650806|O2|Outcome|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
1066514|NCT00650806|O1|Outcome|Placebo|Each patient received matching placebo once daily for 12 weeks.
1066515|NCT00650806|O4|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
1066516|NCT00650806|O3|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
1066517|NCT00650806|O2|Outcome|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
1066518|NCT00650806|O1|Outcome|Placebo|Each patient received matching placebo once daily for 12 weeks.
1066519|NCT00650806|O4|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
1066520|NCT00650806|O3|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
1066521|NCT00650806|O2|Outcome|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
1066522|NCT00650806|O1|Outcome|Placebo|Each patient received matching placebo once daily for 12 weeks.
1066523|NCT00650806|O4|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
1066524|NCT00650806|O3|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
1066525|NCT00650806|O2|Outcome|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
1066526|NCT00650806|O1|Outcome|Placebo|Each patient received matching placebo once daily for 12 weeks.
1066527|NCT00650806|O4|Outcome|Canaglifloziin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
1066528|NCT00650806|O3|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
1066529|NCT00650806|O2|Outcome|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
1066530|NCT00650806|O1|Outcome|Placebo|Each patient received matching placebo once daily for 12 weeks.
1066531|NCT00650806|E4|Reported Event|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
1066532|NCT00650806|E3|Reported Event|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
1066533|NCT00650806|E2|Reported Event|Canagliflozin 50 mg|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.
1066534|NCT00650806|E1|Reported Event|Placebo|Each patient received matching placebo once daily for 12 weeks.
1066535|NCT00650767|B5|Baseline|Total|Total of all reporting groups
1066536|NCT00650767|B4|Baseline|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066537|NCT00650767|B3|Baseline|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066538|NCT00650767|B2|Baseline|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066539|NCT00650767|B1|Baseline|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066540|NCT00650767|P4|Participant Flow|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066541|NCT00650767|P3|Participant Flow|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066542|NCT00650767|P2|Participant Flow|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066543|NCT00650767|P1|Participant Flow|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066544|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066545|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066546|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066547|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066548|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066549|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066550|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066551|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066552|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066553|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066554|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066555|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066556|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066557|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066558|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066559|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066560|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066561|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066562|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066563|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066564|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066565|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066566|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066567|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066568|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066569|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066570|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066571|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066572|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066573|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066574|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066575|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066576|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066577|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066578|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066579|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066580|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066581|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066582|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067145|NCT00649792|O1|Outcome|Fampridine-SR|Tablets, 10 mg, BID
1066583|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066584|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066585|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066586|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066587|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066588|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066589|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066590|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066591|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066592|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066593|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066594|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066595|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066596|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066597|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066598|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066599|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066600|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066601|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066602|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066603|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066604|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066605|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066606|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066607|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066608|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066609|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066610|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066611|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066612|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066613|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066614|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066615|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066616|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066617|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066618|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066619|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066620|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066621|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066622|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066623|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066624|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066625|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066626|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066627|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066628|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066629|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066630|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066631|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066632|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066633|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066634|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066635|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066636|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066637|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066638|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066639|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066640|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066641|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066642|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066643|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066644|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066645|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066646|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066647|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066648|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066649|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066650|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066651|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066652|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066653|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066654|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066655|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066656|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066657|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066658|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066659|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066660|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066661|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066662|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066663|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066664|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066665|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066666|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066667|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066668|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066669|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066670|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066671|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066672|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066673|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066674|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066675|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066676|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066677|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066678|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066679|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066680|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066681|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066682|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066683|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066684|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066685|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066686|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066687|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066688|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066689|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066690|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066691|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066692|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066693|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066694|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066695|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066696|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066697|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066698|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066699|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066700|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066701|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066702|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066703|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066704|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066705|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066706|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066707|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066708|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066709|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066710|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066711|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066712|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066713|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066714|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066715|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066716|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066717|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066718|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066719|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066720|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066721|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066722|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066723|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066724|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066725|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066726|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066727|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066728|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066729|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066730|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066731|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066732|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066733|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066734|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066735|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066736|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066737|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066738|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067146|NCT00649792|O1|Outcome|Fampridine-SR|Tablets, 10 mg, BID
1066739|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066740|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066741|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066742|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066743|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066744|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066745|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066746|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066747|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066748|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066749|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066750|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066751|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066752|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066753|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066754|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066755|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066756|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066757|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066758|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066759|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066760|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066761|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066762|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066763|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066764|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066765|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066766|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066767|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066768|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066769|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066770|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066771|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066772|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066773|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066774|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066775|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066776|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066777|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066778|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066779|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066780|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066781|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066782|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066783|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066784|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066785|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066786|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066787|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066788|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066789|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066790|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066791|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066792|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066793|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066794|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066795|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066796|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066797|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066798|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066799|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066800|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066801|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066802|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066803|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066804|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066805|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066806|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066807|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066808|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066809|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066810|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066811|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066812|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066813|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066814|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066815|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066816|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066817|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066818|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066819|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066820|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066821|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066822|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066823|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066824|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066825|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066826|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066827|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066828|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066829|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066830|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066831|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066832|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066833|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066834|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066835|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066836|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066837|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066838|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066839|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066840|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066841|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066842|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066843|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066844|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066845|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066846|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066847|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066848|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066849|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066850|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066851|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066852|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066853|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066854|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066855|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066856|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066857|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066858|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066859|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066860|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066861|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066862|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066863|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066864|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066865|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066866|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066867|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066868|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066869|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066870|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066871|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066872|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066873|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066874|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066875|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066876|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066877|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066878|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066879|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066880|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066881|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066882|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066883|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066884|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066885|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066886|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066887|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066888|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066889|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066890|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066891|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066892|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066893|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066894|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067147|NCT00649792|O1|Outcome|Fampridine-SR|Tablets, 10 mg, BID
1066895|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066896|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066897|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066898|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066899|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066900|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066901|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066902|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066903|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066904|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066905|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066906|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066907|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066908|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066909|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066910|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066911|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066912|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066913|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066914|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066915|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066916|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066917|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066918|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066919|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066920|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066921|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066922|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066923|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066924|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066925|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066926|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066927|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066928|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066929|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066930|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066931|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066932|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066933|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066934|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066935|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066936|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066937|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066938|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066939|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066940|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066941|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066942|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066943|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066944|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066945|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066946|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066947|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066948|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066949|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066950|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066951|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066952|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066953|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066954|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066955|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066956|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066957|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066958|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066959|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066960|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066961|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066962|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066963|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066964|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066965|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066966|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066967|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066968|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066969|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066970|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066971|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066972|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066973|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066974|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066975|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066976|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066977|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066978|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066979|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066980|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066981|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066982|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066983|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066984|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066985|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066986|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066987|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066988|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066989|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066990|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066991|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066992|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066993|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066994|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066995|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1066996|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066997|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066998|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1066999|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1067000|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067001|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067002|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067003|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1067004|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067005|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067006|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067007|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1067008|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067009|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067010|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067011|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1067012|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067013|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067014|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067015|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1067016|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067017|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067018|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067019|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1067020|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067021|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067022|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067023|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1067024|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067025|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067026|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067027|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1067028|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067029|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067030|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067031|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1067032|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067033|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067034|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067035|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1067036|NCT00650767|O4|Outcome|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067037|NCT00650767|O3|Outcome|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067038|NCT00650767|O2|Outcome|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067039|NCT00650767|O1|Outcome|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1067040|NCT00650767|E4|Reported Event|ARRY-438162: 20 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067041|NCT00650767|E3|Reported Event|ARRY-438162: 40 mg qd|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067042|NCT00650767|E2|Reported Event|ARRY-438162: 10 mg Bid|Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.
1067043|NCT00650767|E1|Reported Event|Placebo|"Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.~Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo."
1067044|NCT00650585|B3|Baseline|Total|Total of all reporting groups
1067045|NCT00650585|B2|Baseline|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
1067046|NCT00650585|B1|Baseline|Control Group|School did not receive Project ALERT, a substance use prevention program
1067047|NCT00650585|P2|Participant Flow|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
1067048|NCT00650585|P1|Participant Flow|Control Group|School did not receive Project ALERT, a substance use prevention program
1067049|NCT00650585|O2|Outcome|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
1067050|NCT00650585|O1|Outcome|Control Group|School did not receive Project ALERT, a substance use prevention program
1067051|NCT00650585|O2|Outcome|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
1067052|NCT00650585|O1|Outcome|Control Group|School did not receive Project ALERT, a substance use prevention program
1067053|NCT00650585|O2|Outcome|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
1067054|NCT00650585|O1|Outcome|Control Group|School did not receive Project ALERT, a substance use prevention program
1067055|NCT00650585|O2|Outcome|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
1067056|NCT00650585|O1|Outcome|Control Group|School did not receive Project ALERT, a substance use prevention program
1067057|NCT00650585|O2|Outcome|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
1067058|NCT00650585|O1|Outcome|Control Group|School did not receive Project ALERT, a substance use prevention program
1067059|NCT00650585|O2|Outcome|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
1067060|NCT00650585|O1|Outcome|Control Group|School did not receive Project ALERT, a substance use prevention program
1067061|NCT00650585|O2|Outcome|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
1067062|NCT00650585|O1|Outcome|Control Group|School did not receive Project ALERT, a substance use prevention program
1067063|NCT00650585|O2|Outcome|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
1067064|NCT00650585|O1|Outcome|Control Group|School did not receive Project ALERT, a substance use prevention program
1067065|NCT00650585|E2|Reported Event|Treatment Group|School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
1067066|NCT00650585|E1|Reported Event|Control Group|School did not receive Project ALERT, a substance use prevention program
1067067|NCT00650546|B1|Baseline|Open-labeled Prospective Case Series|"Exenatide 5 micrograms SQ twice a day titrated to 10 mcg SQ twice a day as tolerated~Exenatide: 5 mcg twice a day titrated to 10 mcg twice a day"
1067068|NCT00650546|P1|Participant Flow|Exenatide Group|"Exenatide 5 micrograms SQ twice a day titrated to 10 mcg SQ twice a day as tolerated~Exenatide : 5 mcg twice a day titrated to 10 mcg twice a day"
1067069|NCT00650546|O1|Outcome|Individuals Who Recieved Treatment With Exenatide|change of NAS score in eight adult patients with known type 2 DM and biopsy proven NAFLD after treatment with exenatide
1067070|NCT00650546|O1|Outcome|Treatment With Exenatide|eight adult patients with known type 2 DM and biopsy proven NAFLD
1067071|NCT00650546|E1|Reported Event|Exenatide Group|"Exenatide 5 micrograms SQ twice a day titrated to 10 mcg SQ twice a day as tolerated~Exenatide : 5 mcg twice a day titrated to 10 mcg twice a day"
1067072|NCT00650260|B3|Baseline|Total|Total of all reporting groups
1067073|NCT00650260|B2|Baseline|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site’s current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
1067074|NCT00650260|B1|Baseline|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
1067075|NCT00650260|P2|Participant Flow|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site’s current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
1067076|NCT00650260|P1|Participant Flow|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
1067077|NCT00650260|O2|Outcome|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site's current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
1067148|NCT00649792|E1|Reported Event|Fampridine-SR|Tablets, 10 mg, BID
1067078|NCT00650260|O1|Outcome|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
1067079|NCT00650260|O2|Outcome|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site's current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
1067080|NCT00650260|O1|Outcome|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
1067081|NCT00650260|O2|Outcome|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site's current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
1067082|NCT00650260|O1|Outcome|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
1067083|NCT00650260|O2|Outcome|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site's current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
1067084|NCT00650260|O1|Outcome|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
1067085|NCT00650260|O2|Outcome|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site's current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
1067086|NCT00650260|O1|Outcome|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
1067149|NCT00649428|B3|Baseline|Total|Total of all reporting groups
1067150|NCT00649428|B2|Baseline|Placebo|Patients treated with placebo solution
1067151|NCT00649428|B1|Baseline|Autologous Fibroblasts|Patients treated with autologous dermal fibroblasts
1067152|NCT00649428|P2|Participant Flow|Placebo|Patients treated with placebo solution
1067153|NCT00649428|P1|Participant Flow|Autologous Fibroblasts|Patients treated with autologous dermal fibroblasts
1067154|NCT00649428|O2|Outcome|Placebo|Patients treated with placebo solution.
1067087|NCT00650260|O2|Outcome|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site's current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
1067088|NCT00650260|O1|Outcome|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
1067089|NCT00650260|E2|Reported Event|Control Group|The Bair Hugger system is the current standard of care at TGH. It consists of a Temperature Management Unit that contains the heating element, the air circulating motor and the temperature control mechanisms. This unit connects via a hose to the operating room blankets. The Bair Hugger technology relies on heated air convection. Warm air is circulated evenly through the air space in the specially designed blanket, warming the skin surface as well as any insulating blankets placed over the Bair Hugger blanket. The Bair Hugger System is the site’s current approach to patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
1067090|NCT00650260|E1|Reported Event|vH2 System Group|The vH2 system consists of a Control Unit containing the heating system and the vacuum generation pump which connects via an umbilical containing the fluid and vacuum tubing to the Warming Sleeve. The Control Unit also contains the user interface and alarm management systems. The disposable Warming Sleeve consists of a manifold attached to the warming pads and a polyurethane pouch (Vacuum Sleeve) that are placed over the patient's hand and forearm and secured with tape. The Warming Sleeve manifold contains connectors for the fluid and vacuum tubing contained in the umbilical. The vH2 System will be used for patient warming during these surgical procedures. Monitoring of core temperature via esophageal probe will be done for the purpose of data collection.
1067091|NCT00650104|B1|Baseline|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
1067092|NCT00650104|P1|Participant Flow|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
1067093|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
1067094|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
1067155|NCT00649428|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
1067156|NCT00649428|O2|Outcome|Placebo|Patients treated with placebo solution.
1067157|NCT00649428|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
1067158|NCT00649428|O2|Outcome|Placebo|Patients treated with placebo solution.
1074098|NCT00629239|O2|Outcome|Placebo|Placebo
1067095|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
1067096|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
1067097|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
1067098|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
1067099|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
1067100|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
1067101|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
1067159|NCT00649428|O1|Outcome|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
1067160|NCT00649428|O2|Outcome|Placebo|Patients treated with placebo solution.
1067161|NCT00649428|O1|Outcome|Autologous Fibroblast|Patients treated with autologous fibroblasts (azficel-T).
1067162|NCT00649428|E2|Reported Event|Placebo|Patients treated with placebo solution.
1067163|NCT00649428|E1|Reported Event|Autologous Fibroblasts|Patients treated with autologous fibroblasts (azficel-T).
1067164|NCT00649389|B5|Baseline|Total|Total of all reporting groups
1067102|NCT00650104|O1|Outcome|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
1067103|NCT00650104|E1|Reported Event|Ropinirole XL|Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.
1067104|NCT00650091|B3|Baseline|Total|Total of all reporting groups
1067105|NCT00650091|B2|Baseline|Placebo|"Participants will receive placebo for 60 weeks.~Placebo: Participants will receive placebo each day."
1067106|NCT00650091|B1|Baseline|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.~N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
1067107|NCT00650091|P3|Participant Flow|Pred/AZA/NAC|"The prednisone dose was started at 0.5 mg per kilo- gram of ideal body weight and was tapered to 0.15 mg per kilogram during a period of 25 weeks.~The azathioprine dose (maximum, 150 mg per day) was based on the patient’s ideal weight, concurrent use of allopurinol, and thiopurine methyl-transferase (TPMT) activity. NAC was prescribed at 600 mg orally three times a day."
1067108|NCT00650091|P2|Participant Flow|Placebo|"Participants will receive placebo for 60 weeks.~Placebo: Participants will receive placebo each day."
1067109|NCT00650091|P1|Participant Flow|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.~N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
1067110|NCT00650091|O2|Outcome|Placebo|"Participants will receive placebo for 60 weeks.~Placebo: Participants will receive placebo each day."
1067111|NCT00650091|O1|Outcome|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.~N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
1067112|NCT00650091|O2|Outcome|Placebo|"Participants will receive placebo for 60 weeks.~Placebo: Participants will receive placebo each day."
1067113|NCT00650091|O1|Outcome|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.~N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
1067114|NCT00650091|O2|Outcome|Placebo|"Participants will receive placebo for 60 weeks.~Placebo: Participants will receive placebo each day."
1067115|NCT00650091|O1|Outcome|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.~N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
1067116|NCT00650091|O2|Outcome|Placebo|"Participants will receive placebo for 60 weeks.~Placebo: Participants will receive placebo each day."
1067117|NCT00650091|O1|Outcome|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.~N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
1067118|NCT00650091|O2|Outcome|Placebo|"Participants will receive placebo for 60 weeks.~Placebo: Participants will receive placebo each day."
1067119|NCT00650091|O1|Outcome|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.~N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
1067120|NCT00650091|O2|Outcome|Placebo|"Participants will receive placebo for 60 weeks.~Placebo: Participants will receive placebo each day."
1067121|NCT00650091|O1|Outcome|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.~N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
1067122|NCT00650091|E4|Reported Event|Initial Study: Placebo|Placebo: Participants will receive placebo each day.
1067123|NCT00650091|E3|Reported Event|Initial Study: Pred/AZA/NAC|Participants will receive prednisone, azathioprine, and N-acetylcysteine (NAC) for 60 weeks.
1067124|NCT00650091|E2|Reported Event|Placebo|"Participants will receive placebo for 60 weeks.~Placebo: Participants will receive placebo each day."
1067125|NCT00650091|E1|Reported Event|N-Acetylcysteine|"Participants will receive N-acetylcysteine (NAC) for 60 weeks.~N-acetylcysteine (NAC): Participants will receive 600 mg of NAC three times a day."
1067126|NCT00650078|B3|Baseline|Total|Total of all reporting groups
1067127|NCT00650078|B2|Baseline|Placebo|
1067128|NCT00650078|B1|Baseline|NP01|Modified Release (MR) prednisone 5 mg
1067129|NCT00650078|P2|Participant Flow|Placebo|
1067130|NCT00650078|P1|Participant Flow|NP01|Modified Release (MR) prednisone 5 mg
1067131|NCT00650078|O2|Outcome|Placebo|
1067132|NCT00650078|O1|Outcome|NP01|Modified Release (MR) prednisone 5 mg
1067133|NCT00650078|O2|Outcome|Placebo|
1067134|NCT00650078|O1|Outcome|NP01|Modified Release (MR) prednisone 5 mg
1067135|NCT00650078|E2|Reported Event|Placebo|
1067136|NCT00650078|E1|Reported Event|NP01|Modified Release (MR) prednisone 5 mg
1067137|NCT00649961|B1|Baseline|Single Arm|open label dose finding study
1067138|NCT00649961|P1|Participant Flow|Melatonin Open Label Single Arm|Open label single arm study
1067139|NCT00649961|O1|Outcome|Single Arm|open label dose finding study
1067140|NCT00649961|E1|Reported Event|Single Arm|open label dose finding study
1067141|NCT00649792|B1|Baseline|Fampridine-SR|Tablets, 10 mg, BID
1067165|NCT00649389|B4|Baseline|OM40/AML10/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
1067166|NCT00649389|B3|Baseline|AML10/HCTZ25|Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
1067167|NCT00649389|B2|Baseline|OM40/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
1067168|NCT00649389|B1|Baseline|OM40/AML10|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
1067169|NCT00649389|P4|Participant Flow|OM40/AML10/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
1067170|NCT00649389|P3|Participant Flow|AML10/HCTZ25|Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
1067171|NCT00649389|P2|Participant Flow|OM40/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
1067172|NCT00649389|P1|Participant Flow|OM40/AML10|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
1067173|NCT00649389|O4|Outcome|OM40/AML10/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
1067174|NCT00649389|O3|Outcome|AML10/HCTZ25|Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
1067175|NCT00649389|O2|Outcome|OM40/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
1067176|NCT00649389|O1|Outcome|OM40/AML10|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
1067177|NCT00649389|O4|Outcome|OM40/AML10/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
1067178|NCT00649389|O3|Outcome|AML10/HCTZ25|Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
1067179|NCT00649389|O2|Outcome|OM40/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
1067180|NCT00649389|O1|Outcome|OM40/AML10|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
1067181|NCT00649389|O4|Outcome|OM40/AML10/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
1067182|NCT00649389|O3|Outcome|AML10/HCTZ25|Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
1067183|NCT00649389|O2|Outcome|OM40/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
1067184|NCT00649389|O1|Outcome|OM40/AML10|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
1067185|NCT00649389|O4|Outcome|OM40/AML10/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
1067186|NCT00649389|O3|Outcome|AML10/HCTZ25|Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
1067187|NCT00649389|O2|Outcome|OM40/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
1067188|NCT00649389|O1|Outcome|OM40/AML10|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
1067189|NCT00649389|E4|Reported Event|OM40/AML10/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg, tablets once daily.
1067190|NCT00649389|E3|Reported Event|AML10/HCTZ25|Double blind treatment Amlodipine (AML) 10 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
1067191|NCT00649389|E2|Reported Event|OM40/HCTZ25|Double blind treatment olmesartan medoxomil (OM) 40 mg, Hydrochlorothiazide (HCTZ) 25 mg tablets once daily.
1067192|NCT00649389|E1|Reported Event|OM40/AML10|Double blind treatment olmesartan medoxomil (OM) 40 mg, Amlodipine (AML) 10 mg tablets once daily.
1067193|NCT00649220|B1|Baseline|Memantine|Memantine tablets, twice a day (bid).
1067194|NCT00649220|P1|Participant Flow|Memantine|Memantine tablets, twice a day (bid).
1067195|NCT00649220|O1|Outcome|Memantine|Memantine tablets, twice a day (bid).
1067196|NCT00649220|O1|Outcome|Memantine|Memantine tablets, twice a day (bid).
1067197|NCT00649220|O1|Outcome|Memantine|Memantine tablets, twice a day (bid).
1067198|NCT00649220|O1|Outcome|Memantine|Memantine tablets, twice a day (bid).
1067199|NCT00649220|O1|Outcome|Memantine|Memantine tablets, twice a day (bid).
1067200|NCT00649220|O1|Outcome|Memantine|Memantine tablets, twice a day (bid).
1067201|NCT00649220|O1|Outcome|Memantine|Memantine tablets, twice a day (bid).
1067202|NCT00649220|O1|Outcome|Memantine|Memantine tablets, twice a day (bid).
1067203|NCT00649220|E1|Reported Event|Memantine|Memantine tablets, twice a day (bid).
1067204|NCT00648908|B1|Baseline|Fampridine-SR|Tablets, 10mg twice daily
1067205|NCT00648908|P1|Participant Flow|Fampridine-SR|Tablets, 10mg twice daily
1067206|NCT00648908|O1|Outcome|Fampridine-SR|Tablets, 10mg twice daily
1067207|NCT00648908|O1|Outcome|Fampridine-SR|Tablets, 10mg twice daily
1067208|NCT00648908|O1|Outcome|Fampridine-SR|Tablets, 10mg twice daily
1067209|NCT00648908|O1|Outcome|Fampridine-SR 10mg (Twice a Day)|
1067210|NCT00648908|O1|Outcome|Fampridine-SR 10mg (Twice a Day)|
1067211|NCT00648908|E1|Reported Event|Fampridine-SR|Tablets, 10mg twice daily
1067212|NCT00648895|B3|Baseline|Total|Total of all reporting groups
1067213|NCT00648895|B2|Baseline|Metoprolol ER (TM)|A 6-week up-titration period (the dose of metoprolol ER was increased from 100 mg/d to a maximum of 400mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase.
1067214|NCT00648895|B1|Baseline|Nebivolol|A 6-week up-titration period (the dose of nebivolol was increased from 10 mg/d to a maximum of 40mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase
1067279|NCT00647556|O1|Outcome|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
1067215|NCT00648895|P2|Participant Flow|Metoprolol ER (TM)|A 6-week up-titration period (the dose of metoprolol ER was increased from 100 mg/d to a maximum of 400mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase.
1067216|NCT00648895|P1|Participant Flow|Nebivolol|A 6-week up-titration period (the dose of nebivolol was increased from 10 mg/d to a maximum of 40mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase
1067217|NCT00648895|O2|Outcome|Metoprolol ER (TM)|A 6-week up-titration period (the dose of metoprolol ER was increased from 100 mg/d to a maximum of 400mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase.
1067218|NCT00648895|O1|Outcome|Nebivolol|A 6-week up-titration period (the dose of nebivolol was increased from 10 mg/d to a maximum of 40mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase
1067219|NCT00648895|E2|Reported Event|Metoprolol ER (TM)|A 6-week up-titration period (the dose of metoprolol ER was increased from 100 mg/d to a maximum of 400mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase.
1067220|NCT00648895|E1|Reported Event|Nebivolol|A 6-week up-titration period (the dose of nebivolol was increased from 10 mg/d to a maximum of 40mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase
1067221|NCT00648167|B1|Baseline|KRX-0502|Subjects in this group were initiated on a dose of 4.5 g/day (34 subjects) or 6.0 g/day (21 subjects) of KRX-0502 (ferric citrate)
1067222|NCT00648167|P1|Participant Flow|KRX-0502|Ferric Citrate
1067223|NCT00648167|O1|Outcome|KRX-0502 (Ferric Citrate)|Patients starting dose of 4.5 grams per day (n=34) and those starting on 6.0 grams per day (n=21)- immediate roll over from previous phosphate binder(s)
1067224|NCT00648167|E1|Reported Event|KRX-0502|"Subjects in this group were initiated on a dose of 4.5 g/day (34 subjects) or 6.0 g/day (21 subjects) of KRX-0502 (ferric citrate)~Intent-to-Treat (ITT)"
1067225|NCT00648115|B4|Baseline|Total|Total of all reporting groups
1067226|NCT00648115|B3|Baseline|Group Program|"a full program consisting of the manualized program with vocational staff and peer vocational support specialists~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
1067227|NCT00648115|B2|Baseline|Self-Study|"Self-study of vocational materials~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
1067228|NCT00648115|B1|Baseline|Basic Vocational Services|Basic vocational services but no manualized vocational program
1067229|NCT00648115|P3|Participant Flow|Group Program|"a full program consisting of the manualized program with vocational staff and peer vocational support specialists~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
1067230|NCT00648115|P2|Participant Flow|Self-Study|"Self-study of vocational materials~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
1067231|NCT00648115|P1|Participant Flow|Basic Vocational Services|Basic vocational services but no manualized vocational program
1067232|NCT00648115|O3|Outcome|Group Program|"a full program consisting of the manualized program with vocational staff and peer vocational support specialists~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
1067233|NCT00648115|O2|Outcome|Self-Study|"Self-study of vocational materials~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
1067234|NCT00648115|O1|Outcome|Basic Vocational Services|Basic vocational services but no manualized vocational program
1067235|NCT00648115|O3|Outcome|Group Program|"a full program consisting of the manualized program with vocational staff and peer vocational support specialists~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
1067280|NCT00647556|O2|Outcome|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
1067281|NCT00647556|O1|Outcome|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
1067282|NCT00647556|E2|Reported Event|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
1067236|NCT00648115|O2|Outcome|Self-Study|"Self-study of vocational materials~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
1067237|NCT00648115|O1|Outcome|Basic Vocational Services|Basic vocational services but no manualized vocational program
1067238|NCT00648115|E3|Reported Event|Arm 3|"a full program consisting of the manualized program with vocational staff and peer vocational support specialists~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
1067239|NCT00648115|E2|Reported Event|Arm 2|"Self-study of vocational materials~comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search."
1067240|NCT00648115|E1|Reported Event|Arm 1|Basic vocational services but no manualized vocational program
1067241|NCT00648037|B1|Baseline|Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT|To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLA mismatched related HSCT
1067242|NCT00648037|P1|Participant Flow|Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT|To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLA mismatched related HSCT
1067243|NCT00648037|O1|Outcome|Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT|To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLA mismatched related HSCT
1067244|NCT00648037|E1|Reported Event|Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT|To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLA mismatched related HSCT
1067245|NCT00647998|B3|Baseline|Total|Total of all reporting groups
1067246|NCT00647998|B2|Baseline|Standard Care|No darbepoetin
1067247|NCT00647998|B1|Baseline|Darbepoetin Alfa|Patients receive 1 mg/kg IV darbepoetin immediately before surgery
1067248|NCT00647998|P2|Participant Flow|Standard Care|No darbepoetin
1067249|NCT00647998|P1|Participant Flow|Darbepoetin Alfa|Patients receive 1 mg/kg IV darbepoetin immediately before surgery
1067250|NCT00647998|O2|Outcome|Standard Care|No darbepoetin
1067251|NCT00647998|O1|Outcome|Darbepoetin Alfa|Patients receive 1 mg/kg IV darbepoetin immediately before surgery
1067252|NCT00647998|O2|Outcome|Standard Care|"No Darbepoetin~Standard care"
1067253|NCT00647998|O1|Outcome|Darbepoetin|"Patients received 1mg/kg IV Darbepoetin immediately prior to surgery~Darbepoetin alfa: Patients will receive one IV injection of Darbepoetin alfa at doses ranging from 1mcg/kg to 6.5 mcg/kg prior to surgery~Standard care"
1067254|NCT00647998|O2|Outcome|Standard Care|No darbepoetin
1067255|NCT00647998|O1|Outcome|Darbepoetin Alfa|Patients receive 1 mg/kg IV darbepoetin immediately before surgery
1067256|NCT00647998|E2|Reported Event|Standard Care|No darbepoetin
1067257|NCT00647998|E1|Reported Event|Darbepoetin Alfa|Patients receive 1 mg/kg IV darbepoetin immediately before surgery
1067258|NCT00647699|B3|Baseline|Total|Total of all reporting groups
1067259|NCT00647699|B2|Baseline|Control Group|riboflavin ophthalmic solution without UVA irradiation
1067260|NCT00647699|B1|Baseline|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
1067261|NCT00647699|P2|Participant Flow|Control Group|riboflavin ophthalmic solution without UVA irradiation
1067262|NCT00647699|P1|Participant Flow|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
1067263|NCT00647699|O2|Outcome|Control Group|riboflavin ophthalmic solution without UVA irradiation
1067264|NCT00647699|O1|Outcome|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
1067265|NCT00647699|E2|Reported Event|Control Group|riboflavin ophthalmic solution without UVA irradiation
1067266|NCT00647699|E1|Reported Event|Corneal Collagen Cross-linking (CXL) Treatment Group|riboflavin ophthalmic solution and UVA irradiation (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
1067267|NCT00647556|B3|Baseline|Total|Total of all reporting groups
1067268|NCT00647556|B2|Baseline|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
1067269|NCT00647556|B1|Baseline|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
1067270|NCT00647556|P2|Participant Flow|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
1067271|NCT00647556|P1|Participant Flow|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
1067272|NCT00647556|O2|Outcome|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
1067273|NCT00647556|O1|Outcome|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
1067274|NCT00647556|O2|Outcome|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
1067275|NCT00647556|O1|Outcome|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
1067276|NCT00647556|O2|Outcome|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
1067277|NCT00647556|O1|Outcome|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
1067278|NCT00647556|O2|Outcome|Tretinoin Emollient Cream|Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks
1067283|NCT00647556|E1|Reported Event|Differin® Gel, 0.3%|adapalene gel 0.3% - apply once daily in the evening for 24 weeks
1067284|NCT00647400|B3|Baseline|Total|Total of all reporting groups
1067285|NCT00647400|B2|Baseline|Adalimumab 80 mg Every Other Week|Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
1067286|NCT00647400|B1|Baseline|Adalimumab 40 mg Every Other Week|Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
1067287|NCT00647400|P2|Participant Flow|Adalimumab 80 mg Every Other Week|Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
1067288|NCT00647400|P1|Participant Flow|Adalimumab 40 mg Every Other Week|Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
1067289|NCT00647400|O2|Outcome|Adalimumab 80 mg Every Other Week|Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
1067290|NCT00647400|O1|Outcome|Adalimumab 40 mg Every Other Week|Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
1067291|NCT00647400|O2|Outcome|Adalimumab 80 mg Every Other Week|Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
1067292|NCT00647400|O1|Outcome|Adalimumab 40 mg Every Other Week|Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
1067293|NCT00647400|O2|Outcome|Adalimumab 80 mg Every Other Week|Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
1067294|NCT00647400|O1|Outcome|Adalimumab 40 mg Every Other Week|Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
1067295|NCT00647400|E2|Reported Event|Adalimumab 80 mg Every Other Week|Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure).
1067296|NCT00647400|E1|Reported Event|Adalimumab 40 mg Every Other Week|Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study.
1067297|NCT00647270|B4|Baseline|Total|Total of all reporting groups
1067298|NCT00647270|B3|Baseline|Adalimumab 80 mg Monthly|Adalimumab 80 mg monthly for Period 1 and Period 2
1067299|NCT00647270|B2|Baseline|Adalimumab 40 mg Eow|Adalimumab 40 mg eow for Period 1 and Period 2
1067300|NCT00647270|B1|Baseline|Placebo|Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
1067301|NCT00647270|P3|Participant Flow|Adalimumab 80 mg Monthly|Adalimumab 80 mg monthly for Period 1 and Period 2
1067302|NCT00647270|P2|Participant Flow|Adalimumab 40 mg Eow|Adalimumab 40 mg eow for Period 1 and Period 2
1067303|NCT00647270|P1|Participant Flow|Placebo|Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
1067304|NCT00647270|O3|Outcome|Adalimumab 80 mg Monthly|Adalimumab 80 mg monthly for Period 1 and Period 2
1067305|NCT00647270|O2|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg eow for Period 1 and Period 2
1067306|NCT00647270|O1|Outcome|Placebo|Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
1067307|NCT00647270|O3|Outcome|Adalimumab 80 mg Monthly|Adalimumab 80 mg monthly for Period 1 and Period 2
1067308|NCT00647270|O2|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg eow for Period 1 and Period 2
1067309|NCT00647270|O1|Outcome|Placebo|Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
1067310|NCT00647270|O3|Outcome|Adalimumab 80 mg Monthly|Adalimumab 80 mg monthly for Period 1 and Period 2
1067311|NCT00647270|O2|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg eow for Period 1 and Period 2
1067312|NCT00647270|O1|Outcome|Placebo|Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
1067313|NCT00647270|O3|Outcome|Adalimumab 80 mg Monthly|Adalimumab 80 mg monthly for Period 1 and Period 2
1067314|NCT00647270|O2|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg eow for Period 1 and Period 2
1067315|NCT00647270|O1|Outcome|Placebo|Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
1067316|NCT00647270|O3|Outcome|Adalimumab 80 mg Monthly|Adalimumab 80 mg monthly for Period 1 and Period 2
1067317|NCT00647270|O2|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg eow for Period 1 and Period 2
1067318|NCT00647270|O1|Outcome|Placebo|Placebo 40 mg every other week (eow) for 12 weeks for Period 1; Adalimumab 40 mg eow for remaining 12 weeks for Period 2
1067319|NCT00647270|E6|Reported Event|Adalimumab 80 mg Monthly - Period 2|Adalimumab 80 mg monthly for Period 1 and Period 2
1067320|NCT00647270|E5|Reported Event|Adalimumab 40 mg Eow-Period 2|Adalimumab 40 mg eow for Period 1 and Period 2
1067321|NCT00647270|E4|Reported Event|Placebo/Adalimumab 40 mg Eow-Period 2|Placebo 40 mg eow for Period 1 (weeks 1-12) Subjects switched to Adalimumab 40 mg eow for remaining 12 weeks for Period 2
1067322|NCT00647270|E3|Reported Event|Adalimumab 80 mg Monthly-Period 1|Adalimumab 80 mg monthly for Period 1 and Period 2
1067323|NCT00647270|E2|Reported Event|Adalimumab 40 mg Eow -Period 1|Adalimumab 40 mg eow for Period 1 and Period 2
1067324|NCT00647270|E1|Reported Event|Placebo Every Other Week (Eow)-Period 1|Placebo eow for 12 weeks for Period 1 Adalimumab 40 mg eow for remaining 12 weeks for Period 2
1067325|NCT00646958|B4|Baseline|Total|Total of all reporting groups
1067326|NCT00646958|B3|Baseline|Linezolid BID|600 mg by mouth (PO) BID
1067327|NCT00646958|B2|Baseline|Radezolid BID|450 mg by mouth (PO) twice daily (BID)
1067328|NCT00646958|B1|Baseline|Radezolid QD|450 mg by mouth (PO) once daily (QD)
1067329|NCT00646958|P3|Participant Flow|Linezolid BID|600 mg by mouth (PO) BID
1067330|NCT00646958|P2|Participant Flow|Radezolid BID|450 mg by mouth (PO) twice daily (BID)
1067331|NCT00646958|P1|Participant Flow|Radezolid QD|450 mg by mouth (PO) once daily (QD)
1067332|NCT00646958|O3|Outcome|Linezolid BID|600 mg by mouth (PO) BID
1067333|NCT00646958|O2|Outcome|Radezolid BID|450 mg by mouth (PO) twice daily (BID)
1067334|NCT00646958|O1|Outcome|Radezolid QD|450 mg by mouth (PO) once daily (QD)
1067335|NCT00646958|O3|Outcome|Linezolid BID|600 mg by mouth (PO) BID
1067336|NCT00646958|O2|Outcome|Radezolid BID|450 mg by mouth (PO) twice daily (BID)
1067337|NCT00646958|O1|Outcome|Radezolid QD|450 mg by mouth (PO) once daily (QD)
1067338|NCT00646958|E3|Reported Event|Linezolid BID|600 mg by mouth (PO) BID
1067339|NCT00646958|E2|Reported Event|Radezolid BID|450 mg by mouth (PO) twice daily (BID)
1067340|NCT00646958|E1|Reported Event|Radezolid QD|450 mg by mouth (PO) once daily (QD)
1067341|NCT00646776|B3|Baseline|Total|Total of all reporting groups
1067342|NCT00646776|B2|Baseline|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067343|NCT00646776|B1|Baseline|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067344|NCT00646776|P2|Participant Flow|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067345|NCT00646776|P1|Participant Flow|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067346|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067347|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067348|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067349|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067350|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067351|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067352|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067446|NCT00646399|O1|Outcome|Pagibaximab|
1067447|NCT00646399|E2|Reported Event|Placebo|
1067448|NCT00646399|E1|Reported Event|Pagibaximab|
1067353|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067354|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067355|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067356|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067357|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067358|NCT00646776|O3|Outcome|RIB 300 mg QD|AUCtot for RIB 300 mg QD was calculated as 2 × AUCtot for RIB 150 mg QD.
1067359|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QAD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067360|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067361|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067362|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067363|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067364|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067365|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067366|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067367|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067368|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067369|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067370|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067449|NCT00646282|B3|Baseline|Total|Total of all reporting groups
1067450|NCT00646282|B2|Baseline|Control|Stable kidney transplant recipients do not receive any drug
1074099|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
1067371|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067372|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067373|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067374|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067375|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067376|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067377|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067378|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067379|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067380|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067381|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067382|NCT00646776|O1|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were randomized to receive Atazanavir/Ritonavir 300/100mg orally once daily on Days 1 to 17. Participants also received oral dose of Rifabutin 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Participants were dosed in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067383|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067384|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067385|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067386|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067387|NCT00646776|O2|Outcome|ATV/RTV 300/100 mg QD+RIB 150 mg Twice Weekly|Participants were administered an oral dose of atazanavir/ritonavir (ATV/RTV) 300/100 mg QD on Days 1 to 17 and an oral dose of RIB 150 mg twice weekly on Days 1, 4, 8, 11 and 15. Study treatment was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067388|NCT00646776|O1|Outcome|RIB 150 mg Once Daily (QD)|Participants were administered an oral dose of rifabutin (RIB) 150 mg QD on Days 1 to 10. RIB was given in the morning within 5 minutes of completing a light meal. Participants were admitted to the clinical facility the evening prior to dosing (Day -1) and remained confined for the duration of the study.
1067389|NCT00646776|E2|Reported Event|RIB 150mg|
1067390|NCT00646776|E1|Reported Event|ATV/RTV 300/100mg+RIB 150mg|
1067391|NCT00646763|B3|Baseline|Total|Total of all reporting groups
1067392|NCT00646763|B2|Baseline|Extremities|The extremity arm will have their injections administered to their upper and/or lower extremities.
1067393|NCT00646763|B1|Baseline|Abdomen|These subjects will have their cytokine injections administered only to their abdomen.
1067394|NCT00646763|P2|Participant Flow|Extremities|The extremity arm will have their injections administered to their upper and/or lower extremities.
1067395|NCT00646763|P1|Participant Flow|Abdomen|These subjects will have their cytokine injections administered only to their abdomen.
1067396|NCT00646763|O2|Outcome|Extremities|The extremity arm will have their injections administered to their upper and/or lower extremities.
1067397|NCT00646763|O1|Outcome|Abdomen|These subjects will have their cytokine injections administered only to their abdomen.
1067398|NCT00646763|O2|Outcome|Extremities|The extremity arm will have their injections administered to their upper and/or lower extremities.
1067399|NCT00646763|O1|Outcome|Abdomen|These subjects will have their cytokine injections administered only to their abdomen.
1067400|NCT00646763|O2|Outcome|Extremities|The extremity arm will have their injections administered to their upper and/or lower extremities.
1067401|NCT00646763|O1|Outcome|Abdomen|These subjects will have their cytokine injections administered only to their abdomen.
1067402|NCT00646763|E2|Reported Event|Extremities|The extremity arm will have their injections administered to their upper and/or lower extremities.
1067403|NCT00646763|E1|Reported Event|Abdomen|These subjects will have their cytokine injections administered only to their abdomen.
1067404|NCT00646646|B5|Baseline|Total|Total of all reporting groups
1067405|NCT00646646|B4|Baseline|Propofol|"active drug~propofol : sedative"
1067406|NCT00646646|B3|Baseline|Placebo|"placebo control~saline placebo : saline placebo"
1067407|NCT00646646|B2|Baseline|Midazolam|"Sedative~Midazolam : sedative"
1067408|NCT00646646|B1|Baseline|Dexmedetomidine|"sedative~dexmedetomidine : Sedative"
1067409|NCT00646646|P4|Participant Flow|Propofol|Sedative Drug 3
1067410|NCT00646646|P3|Participant Flow|Placebo|Placebo Control
1067411|NCT00646646|P2|Participant Flow|Midazolam|Sedative Drug 2
1067412|NCT00646646|P1|Participant Flow|Dexmedetomidine|Sedative Drug 1
1067413|NCT00646646|O4|Outcome|Placebo|placebo
1067414|NCT00646646|O3|Outcome|Propofol|"active drug~propofol : sedative"
1067415|NCT00646646|O2|Outcome|Midazolam|"Sedative~Midazolam : sedative"
1067416|NCT00646646|O1|Outcome|Dexmedetomidine|"sedative~dexmedetomidine : Sedative"
1067417|NCT00646646|E4|Reported Event|Propofol|"active drug~propofol : sedative"
1067418|NCT00646646|E3|Reported Event|Placebo|"placebo control~saline placebo : saline placebo"
1067419|NCT00646646|E2|Reported Event|Midazolam|"Sedative~Midazolam : sedative"
1067420|NCT00646646|E1|Reported Event|Dexmedetomidine|"sedative~dexmedetomidine : Sedative"
1067421|NCT00646581|B3|Baseline|Total|Total of all reporting groups
1067422|NCT00646581|B2|Baseline|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
1067423|NCT00646581|B1|Baseline|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
1067424|NCT00646581|P2|Participant Flow|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
1067425|NCT00646581|P1|Participant Flow|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
1067426|NCT00646581|O2|Outcome|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
1067427|NCT00646581|O1|Outcome|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
1067428|NCT00646581|O2|Outcome|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
1067429|NCT00646581|O1|Outcome|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
1067430|NCT00646581|O2|Outcome|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
1067431|NCT00646581|O1|Outcome|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
1067432|NCT00646581|O2|Outcome|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
1067433|NCT00646581|O1|Outcome|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
1067434|NCT00646581|O2|Outcome|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
1067435|NCT00646581|O1|Outcome|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
1067436|NCT00646581|O2|Outcome|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
1067437|NCT00646581|O1|Outcome|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
1067438|NCT00646581|E2|Reported Event|Single-Dose Intranasal Insulin|Subjects are given a one-time, single dose of intranasal insulin
1067439|NCT00646581|E1|Reported Event|Placebo (1)|Subjects are given a one-time, single dose of placebo intranasal spray
1067440|NCT00646399|B3|Baseline|Total|Total of all reporting groups
1067441|NCT00646399|B2|Baseline|Placebo|
1067442|NCT00646399|B1|Baseline|Pagibaximab|
1067443|NCT00646399|P2|Participant Flow|Placebo|
1067444|NCT00646399|P1|Participant Flow|Pagibaximab|
1067445|NCT00646399|O2|Outcome|Placebo|
1067451|NCT00646282|B1|Baseline|Doxercalciferol|Stable kidney transplant recipients will receive Doxercalciferol. The drug dosage will be initiated according to baseline iPTH levels. For patients with iPTH>300 pg/ml, oral Doxercalciferol will be given at 1 mcg/day; for patients with iPTH <300 pg/ml, oral Doxercalciferol will be initiated at 0.5 mcg/day.
1067452|NCT00646282|P2|Participant Flow|Control|Stable kidney transplant recipients do not receive any drug.
1067453|NCT00646282|P1|Participant Flow|Doxercalciferol|Stable kidney transplant recipients will receive Doxercalciferol. The drug dosage will be initiated according to baseline iPTH levels. For patients with iPTH>300 pg/ml, oral Doxercalciferol will be given at 1 mcg/day; for patients with iPTH <300 pg/ml, oral Doxercalciferol will be initiated at 0.5 mcg/day.
1067454|NCT00646282|O2|Outcome|Control|Stable kidney transplant recipients will not receive any drug
1067455|NCT00646282|O1|Outcome|Doxercalciferol|Stable kidney transplant recipients will receive Doxercalciferol. The drug dosage will be initiated according to baseline iPTH levels. For patients with iPTH>300 pg/ml, oral Doxercalciferol will be given at 1 mcg/day; for patients with iPTH <300 pg/ml, oral Doxercalciferol will be initiated at 0.5 mcg/day.
1067456|NCT00646282|E2|Reported Event|Control|Stable kidney transplant recipients will not receive any drug
1067457|NCT00646282|E1|Reported Event|Doxercalciferol|Stable kidney transplant recipients will receive Doxercalciferol. The drug dosage will be initiated according to baseline iPTH levels. For patients with iPTH>300 pg/ml, oral Doxercalciferol will be given at 1 mcg/day; for patients with iPTH <300 pg/ml, oral Doxercalciferol will be initiated at 0.5 mcg/day.
1067458|NCT00646048|B1|Baseline|TriVascular Stent Graft|This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
1067459|NCT00646048|P1|Participant Flow|TriVascular Stent Graft|This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
1067460|NCT00646048|O1|Outcome|TriVascular Stent Graft|This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
1067461|NCT00646048|O1|Outcome|TriVascular Stent Graft|This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
1067462|NCT00646048|O1|Outcome|TriVascular Stent Graft|This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
1067463|NCT00646048|E1|Reported Event|TriVascular Stent Graft|This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
1067464|NCT00645970|B3|Baseline|Total|Total of all reporting groups
1067465|NCT00645970|B2|Baseline|Registry|Participants recruited from the OEF/OIF/OND registry
1067466|NCT00645970|B1|Baseline|Polytrauma System of Care (PSC)|Participants recruited from the Polytrauma System of Care
1067467|NCT00645970|P2|Participant Flow|Registry|Participants recruited from the OEF/OIF/OND registry
1067468|NCT00645970|P1|Participant Flow|Polytrauma System of Care (PSC)|Participants recruited from the Polytrauma System of Care (PSC)
1067469|NCT00645970|O2|Outcome|Registry|Participants recruited from the OEF/OIF/OND registry
1067470|NCT00645970|O1|Outcome|Polytrauma System of Care (PSC)|Participants recruited from the Polytrauma System of Care (PSC)
1067471|NCT00645970|E2|Reported Event|Registry|Participants recruited from the OEF/OIF/OND registry
1067472|NCT00645970|E1|Reported Event|Polytrauma System of Care (PSC)|Participants recruited from the Polytrauma System of Care
1067473|NCT00645944|B3|Baseline|Total|Total of all reporting groups
1067474|NCT00645944|B2|Baseline|Placebo Group|"Participants assigned to this arm will receive placebo (an inactive substance or a sugar pill) to be taken each night for all weeks of the study.~Placebo: Placebo or inactive substance (sugar pill)taken each night for all weeks of the study"
1067475|NCT00645944|B1|Baseline|Eszopiclone Group|"Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.~Eszopiclone: Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks."
1067476|NCT00645944|P2|Participant Flow|Placebo Group|"Participants assigned to this arm will receive placebo (an inactive substance or a sugar pill) to be taken each night for all weeks of the study.~Placebo: Placebo or inactive substance (sugar pill)taken each night for all weeks of the study"
1067477|NCT00645944|P1|Participant Flow|Eszopiclone Group|"Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.~Eszopiclone: Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks."
1067478|NCT00645944|O2|Outcome|Placebo Group|"Participants assigned to this arm will receive placebo (an inactive substance or a sugar pill) to be taken each night for all weeks of the study.~Placebo: Placebo or inactive substance (sugar pill)taken each night for all weeks of the study"
1067479|NCT00645944|O1|Outcome|Eszopiclone Group|"Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.~Eszopiclone: Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks."
1067480|NCT00645944|E2|Reported Event|Placebo Group|"Participants assigned to this arm will receive placebo (an inactive substance or a sugar pill) to be taken each night for all weeks of the study.~Placebo: Placebo or inactive substance (sugar pill)taken each night for all weeks of the study"
1068066|NCT00643916|O4|Outcome|Vaccinated at Age 15 Months|Participants received Menactra vaccine at 15 months of age
1067481|NCT00645944|E1|Reported Event|Eszopiclone Group|"Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.~Eszopiclone: Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks."
1067482|NCT00645853|B3|Baseline|Total|Total of all reporting groups
1067483|NCT00645853|B2|Baseline|VKA, INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
1067484|NCT00645853|B1|Baseline|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
1067485|NCT00645853|P2|Participant Flow|VKA, INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
1067486|NCT00645853|P1|Participant Flow|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
1067487|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
1067488|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
1067489|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
1067490|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
1067491|NCT00645853|O2|Outcome|VKA, INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
1067492|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
1067493|NCT00645853|O2|Outcome|VKA, INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
1067494|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
1067495|NCT00645853|O2|Outcome|VKA, INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
1067496|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
1067497|NCT00645853|O2|Outcome|VKA, INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
1067498|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
1067499|NCT00645853|O2|Outcome|VKA, INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
1067500|NCT00645853|O1|Outcome|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od, then switching to one general common dose, 300 mg od.
1067501|NCT00645853|E2|Reported Event|VKA INR 2-3|Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5
1067502|NCT00645853|E1|Reported Event|AZD0837|Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od and then switching to one general common dose, 300 mg od
1067503|NCT00645827|B3|Baseline|Total|Total of all reporting groups
1067504|NCT00645827|B2|Baseline|Control|"Judgment of patient's healthcare provider is used to determine subcutaneous insulin dosing for first 24 hours after cessation of IV insulin infusion.~Healthcare Provider dosing: Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
1067505|NCT00645827|B1|Baseline|Insulin Infusion Conversion Equation|"Insulin infusion conversion equation is used to determine subcutaneous insulin dosing for first 24 hours after cessation of an IV insulin infusion.~IICE Dosing: Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
1067506|NCT00645827|P2|Participant Flow|Control|"Judgment of patient's healthcare provider is used to determine subcutaneous insulin dosing for first 24 hours after cessation of IV insulin infusion.~Healthcare Provider dosing: Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
1068067|NCT00643916|O3|Outcome|Vaccinated at Age 12 and 15 Months|Participants received Menactra vaccine at 12 months and 15 months of age
1067507|NCT00645827|P1|Participant Flow|Insulin Infusion Conversion Equation|"Insulin infusion conversion equation is used to determine subcutaneous insulin dosing for first 24 hours after cessation of an IV insulin infusion.~IICE Dosing: Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
1067508|NCT00645827|O2|Outcome|Control|"Judgment of patient's healthcare provider is used to determine subcutaneous insulin dosing for first 24 hours after cessation of IV insulin infusion.~Healthcare Provider dosing: Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
1067509|NCT00645827|O1|Outcome|Insulin Infusion Conversion Equation|"Insulin infusion conversion equation is used to determine subcutaneous insulin dosing for first 24 hours after cessation of an IV insulin infusion.~IICE Dosing: Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
1067510|NCT00645827|E2|Reported Event|Control|"Judgment of patient's healthcare provider is used to determine subcutaneous insulin dosing for first 24 hours after cessation of IV insulin infusion.~Healthcare Provider dosing: Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
1067511|NCT00645827|E1|Reported Event|Insulin Infusion Conversion Equation|"Insulin infusion conversion equation is used to determine subcutaneous insulin dosing for first 24 hours after cessation of an IV insulin infusion.~IICE Dosing: Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]). For BG < 70 mg/dL, ½ ampule D50W IV x1 was given."
1067512|NCT00645788|B5|Baseline|Total|Total of all reporting groups
1067513|NCT00645788|B4|Baseline|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
1067514|NCT00645788|B3|Baseline|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
1067515|NCT00645788|B2|Baseline|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
1067516|NCT00645788|B1|Baseline|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.50 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
1067517|NCT00645788|P4|Participant Flow|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
1067518|NCT00645788|P3|Participant Flow|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
1067519|NCT00645788|P2|Participant Flow|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
1067520|NCT00645788|P1|Participant Flow|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.50 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
1067521|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
1067522|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
1067523|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
1067524|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
1067525|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
1068470|NCT00642694|B1|Baseline|Escitalopram + Ramelteon|active augmentation
1067526|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
1067527|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
1067528|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
1067529|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
1067530|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
1067531|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
1067532|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
1067533|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
1067534|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
1067535|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
1067536|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
1067537|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
1067538|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
1067539|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
1067540|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
1067541|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
1067542|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
1067543|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
1067544|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
1067545|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
1067546|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
1067547|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
1067548|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
1067549|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
1067550|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
1067551|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
1067552|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
1067553|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
1067554|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
1067555|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
1067556|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
1067557|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
1067558|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
1067559|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
1067560|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
1067561|NCT00645788|O4|Outcome|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
1067562|NCT00645788|O3|Outcome|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
1067563|NCT00645788|O2|Outcome|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
1068068|NCT00643916|O2|Outcome|Vaccinated at Age 9 and 15 Months|Participants received Menactra vaccine at 9 months and 15 months of age
1067564|NCT00645788|O1|Outcome|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
1067565|NCT00645788|E4|Reported Event|Matching Placebo for 48.75 mg|Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days
1067566|NCT00645788|E3|Reported Event|Matching Placebo for 32.50 mg|Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days
1067567|NCT00645788|E2|Reported Event|48.75 mg Ciprofloxacin DPI (BAYQ3939)|48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
1067568|NCT00645788|E1|Reported Event|32.50 mg Ciprofloxacin DPI (BAYQ3939)|32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
1067569|NCT00645762|B1|Baseline|Balloon Dilation|
1067570|NCT00645762|P1|Participant Flow|FinESS Sisnus System Balloon Dilation|Transantral balloon dilation ofthe maxillary sinuses with the FinESS Sinus System.
1067571|NCT00645762|O1|Outcome|FinESS Balloon Arm|Subjects completing 12 month post-procedure follow-up
1067572|NCT00645762|O1|Outcome|FinESS Balloon Dilation|
1067573|NCT00645762|O1|Outcome|Treatment Group (ALL)|FinESS Balloon Dilation
1067574|NCT00645762|E1|Reported Event|Treatment Group (ALL)|
1067575|NCT00645671|B3|Baseline|Total|Total of all reporting groups
1067576|NCT00645671|B2|Baseline|Vehicle|Vehicle of loteprednol etabonate ointment
1067577|NCT00645671|B1|Baseline|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic ointment
1067578|NCT00645671|P2|Participant Flow|Vehicle|Vehicle of loteprednol etabonate ointment
1067579|NCT00645671|P1|Participant Flow|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic ointment
1067580|NCT00645671|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ointment
1067581|NCT00645671|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic ointment
1067582|NCT00645671|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ointment
1067583|NCT00645671|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic ointment
1067584|NCT00645671|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ointment
1067585|NCT00645671|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic ointment
1067586|NCT00645671|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ointment
1067587|NCT00645671|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic ointment
1067588|NCT00645671|E2|Reported Event|Vehicle|Vehicle of loteprednol etabonate ointment
1067589|NCT00645671|E1|Reported Event|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic ointment
1067590|NCT00645593|B3|Baseline|Total|Total of all reporting groups
1067591|NCT00645593|B2|Baseline|Arm 2, Cetuximab, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
1067592|NCT00645593|B1|Baseline|Arm 1, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
1067593|NCT00645593|P2|Participant Flow|Arm 2, Cetuximab, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
1067594|NCT00645593|P1|Participant Flow|Arm 1, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
1067595|NCT00645593|O2|Outcome|Arm 2, Cetuximab, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
1067596|NCT00645593|O1|Outcome|Arm 1, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
1067597|NCT00645593|O2|Outcome|Arm 2, Cetuximab, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
1067598|NCT00645593|O1|Outcome|Arm 1, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
1067599|NCT00645593|O2|Outcome|Arm 2, Cetuximab, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
1067600|NCT00645593|O1|Outcome|Arm 1, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
1068069|NCT00643916|O1|Outcome|Vaccinated at Age 9 and 12 Months|Participants received Menactra vaccine at 9 and 12 months of age
1067601|NCT00645593|O2|Outcome|Arm 2, Cetuximab, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
1067602|NCT00645593|O1|Outcome|Arm 1, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
1067603|NCT00645593|E2|Reported Event|Arm 2, Cetuximab, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin and Cetuximab: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 800 mg/m2 on Days 1, 8 and 15 of cycle. Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.
1067604|NCT00645593|E1|Reported Event|Arm 1, Gemcitabine and Cisplatin|Gemcitabine, Cisplatin: Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle. Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.
1067605|NCT00645567|B1|Baseline|Wheelchair Transfer Interventions|Persons with SCI who evaluated wheelchair transfer interventions
1067606|NCT00645567|P1|Participant Flow|Wheelchair Transfer Interventions|5 persons with SCI were recruited and provided informed consent. Four completed the protocol. One was dropped due to an unrelated injury to the subjects hand at his home.
1067607|NCT00645567|O5|Outcome|Unassisted Manual Transfer|As of the November 2012 update to the IRB, 4 individuals were reported to actively take part in the study but verifiable data is not available for any of the participants.
1067608|NCT00645567|O4|Outcome|Ryno Lift|As of the November 2012 update to the IRB, 4 individuals were reported to actively take part in the study but verifiable data is not available for any of the participants.
1067609|NCT00645567|O3|Outcome|Easy Reach Lift|As of the November 2012 update to the IRB, 4 individuals were reported to actively take part in the study but verifiable data is not available for any of the participants.
1067610|NCT00645567|O2|Outcome|Standard Transfer Board|As of the November 2012 update to the IRB, 4 individuals were reported to actively take part in the study, but verifiable data is not available for any of the participants.
1067611|NCT00645567|O1|Outcome|Glide n' Go|As of the November 2012 update to the IRB, 4 individuals were reported to actively take part in the study, but verifiable data is not available for any of the participants.
1067612|NCT00645567|E1|Reported Event|Group 1|persons with SCI
1067613|NCT00645528|B1|Baseline|Insulin Education Class Participants|"Participation in an insulin educational class~Group Education: Participation in an insulin educational class"
1067614|NCT00645528|P1|Participant Flow|Insulin Education Class Participants|"Subjects attended two group visits, two weeks apart, during which they received education regarding goals of therapy, insulin use, and hypoglycemia. Self-monitored blood glucose values were reviewed and insulin was initiated, if felt appropriate by the physician investigator and if accepted by the subject. The Barriers to Insulin Treatment Questionnaire (BIT) was completed at the start of the first visit and at the end of the second visit.The BIT is a 14 item self-administered questionnaire with 5 subscales, each representing a different psychological barrier to insulin treatment.~Additionally, at the second visit, proportion of blood glucose readings below 70 mg/dl were recorded. All patients were asked how many times in the two weeks they experienced symptoms/signs of low blood sugar, how many times they required sugar intake for the these symptoms, and how many times they required another person to assist them."
1067615|NCT00645528|O1|Outcome|Insulin Education Class Participants|"Participation in an insulin educational class~Group Education: Participation in an insulin educational class"
1067616|NCT00645528|O1|Outcome|Insulin Education Class Participants|"Participation in an insulin educational class~Group Education: Participation in an insulin educational class"
1067617|NCT00645528|O1|Outcome|Insulin Education Class Participants|"Participation in an insulin educational class~Group Education: Participation in an insulin educational class"
1067618|NCT00645528|O1|Outcome|Insulin Education Class Participants|"Participation in an insulin educational class~Group Education: Participation in an insulin educational class"
1067619|NCT00645528|O1|Outcome|Insulin Education Class Participants|"Participation in an insulin educational class~Group Education: Participation in an insulin educational class"
1067620|NCT00645528|O1|Outcome|Insulin Education Class Participants|"Participation in an insulin educational class~Group Education: Participation in an insulin educational class"
1067621|NCT00645528|E1|Reported Event|Arm 1|"Participation in an insulin educational class~Group Education: Participation in an insulin educational class"
1067622|NCT00645411|B5|Baseline|Total|Total of all reporting groups
1067623|NCT00645411|B4|Baseline|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
1067624|NCT00645411|B3|Baseline|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
1067625|NCT00645411|B2|Baseline|Cohort 1+2 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg-derived trivalent influenza vaccine.
1067626|NCT00645411|B1|Baseline|Cohort 1+2 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
1067627|NCT00645411|P4|Participant Flow|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
1067628|NCT00645411|P3|Participant Flow|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
1067629|NCT00645411|P2|Participant Flow|Cohort 1+2 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg -derived trivalent influenza vaccine.
1067630|NCT00645411|P1|Participant Flow|Cohort 1+2 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
1068471|NCT00642694|P2|Participant Flow|Escitalopram + Placebo|Placebo augmentation
1067631|NCT00645411|O2|Outcome|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg- derived trivalent influenza vaccine.
1067632|NCT00645411|O1|Outcome|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
1067633|NCT00645411|O2|Outcome|Cohort 1+2 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg -derived trivalent influenza vaccine.
1067634|NCT00645411|O1|Outcome|Cohort 1+2 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
1067635|NCT00645411|O2|Outcome|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
1067636|NCT00645411|O1|Outcome|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
1067637|NCT00645411|O2|Outcome|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
1067638|NCT00645411|O1|Outcome|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
1067639|NCT00645411|O2|Outcome|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
1067640|NCT00645411|O1|Outcome|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
1067641|NCT00645411|O2|Outcome|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
1067642|NCT00645411|O1|Outcome|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
1067643|NCT00645411|O2|Outcome|Cohort 1 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg-derived trivalent influenza vaccine.
1067644|NCT00645411|O1|Outcome|Cohort 1 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
1067645|NCT00645411|O2|Outcome|Cohort 1 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg-derived trivalent influenza vaccine.
1067646|NCT00645411|O1|Outcome|Cohort 1 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
1067647|NCT00645411|O2|Outcome|Cohort 1 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg-derived trivalent influenza vaccine.
1067648|NCT00645411|O1|Outcome|Cohort 1 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
1067649|NCT00645411|O2|Outcome|Cohort 1 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg-derived trivalent influenza vaccine.
1067650|NCT00645411|O1|Outcome|Cohort 1 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine
1067651|NCT00645411|O2|Outcome|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
1067652|NCT00645411|O1|Outcome|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
1067653|NCT00645411|O2|Outcome|Cohort 3 eTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg - derived trivalent influenza vaccine.
1067654|NCT00645411|O1|Outcome|Cohort 3 cTIV (3-8 Years)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
1067655|NCT00645411|E6|Reported Event|Cohort 3 eTIV (3-8 Yrs; 2nd Vaccination)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
1067656|NCT00645411|E5|Reported Event|Cohort 3 cTIV (3-8 Yrs; 2nd Vaccination)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
1067657|NCT00645411|E4|Reported Event|Cohort 3 eTIV (3-8 Yrs; 1st Vaccination)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
1067658|NCT00645411|E3|Reported Event|Cohort 3 cTIV (3-8 Yrs; 1st Vaccination)|All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
1067659|NCT00645411|E2|Reported Event|Cohort 1+2 eTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of egg -derived trivalent influenza vaccine.
1067660|NCT00645411|E1|Reported Event|Cohort 1+2 cTIV (9-17 Years)|All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
1067661|NCT00645359|B1|Baseline|Diffusion MRI|Participants will undergo two Diffusion MRIs (Magnetic Resonance Imaging) at at baseline and Cycle 1 Day 8.
1067662|NCT00645359|P1|Participant Flow|Diffusion MRI|Participants will undergo two Diffusion MRIs (Magnetic Resonance Imaging) at at baseline and Cycle 1 Day 8.
1067663|NCT00645359|O1|Outcome|Diffusion MRI|Participants will undergo two Diffusion MRIs (Magnetic Resonance Imaging) at at baseline and Cycle 1 Day 8.
1067664|NCT00645359|O1|Outcome|Diffusion MRI|Participants will undergo two Diffusion MRIs (Magnetic Resonance Imaging) at at baseline and Cycle 1 Day 8.
1067665|NCT00645359|E1|Reported Event|Diffusion MRI|Participants will undergo two Diffusion MRIs (Magnetic Resonance Imaging) at at baseline and Cycle 1 Day 8.
1067666|NCT00645333|B1|Baseline|MK-0752 and Docetaxel|MK-0752 in escalating doses, orally days 1-3, followed by docetaxel 80 mg/m2 IV on day 8, and pegfilgrastim 6mg SQ day 9. Cycle repeated every 21 days.
1067667|NCT00645333|P1|Participant Flow|MK-0752 and Docetaxel|MK-0752 in escalating doses, orally days 1-3, followed by docetaxel 80 mg/m2 IV on day 8, and pegfilgrastim 6mg SQ day 9. Cycle repeated every 21 days.
1068070|NCT00643916|E6|Reported Event|Vaccinated at Age 3 Years to <6 Years|Participants received Menomune vaccine at age 3 years to <6 years of age
1067668|NCT00645333|O1|Outcome|MK-0752 and Docetaxel|MK-0752 in escalating doses, orally days 1-3, followed by docetaxel 80 mg/m2 IV on day 8, and pegfilgrastim 6mg SQ day 9. Cycle repeated every 21 days.
1067669|NCT00645333|O1|Outcome|MK-0752 and Docetaxel|MK-0752 in escalating doses, orally days 1-3, followed by docetaxel 80 mg/m2 IV on day 8, and pegfilgrastim 6mg SQ day 9. Cycle repeated every 21 days.
1067670|NCT00645333|E1|Reported Event|MK-0752|MK-0752 in escalating doses, orally days 1-3, followed by docetaxel 80 mg/m2 IV on day 8, and pegfilgrastim 6mg SQ day 9. Cycle repeated every 21 days.
1067671|NCT00645164|B1|Baseline|Xenaderm|Subject serves as own control
1067672|NCT00645164|P1|Participant Flow|Xenaderm|Subject serves as own control
1067673|NCT00645164|O1|Outcome|Xenaderm|Subject serves as own control
1067674|NCT00645164|E1|Reported Event|Xenaderm|Subject serves as own control
1067675|NCT00645099|B3|Baseline|Total|Total of all reporting groups
1067676|NCT00645099|B2|Baseline|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
1067677|NCT00645099|B1|Baseline|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
1067678|NCT00645099|P2|Participant Flow|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
1067679|NCT00645099|P1|Participant Flow|Paliperidone Extended Release (ER)|6-mg or 9-mg tablet once daily flexible dosing for 6 months
1067680|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
1067681|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
1067682|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
1067683|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
1067684|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
1067685|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
1067686|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
1067687|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
1067688|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
1067689|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
1067690|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
1067691|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
1067692|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
1067693|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
1067694|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
1067695|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
1067696|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
1067697|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
1067698|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
1067699|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
1067700|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
1067701|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
1067702|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
1067703|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
1067704|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
1067705|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
1067706|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
1067707|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
1067708|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
1067709|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
1067710|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
1067711|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
1067712|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
1067713|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
1067714|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
1067715|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
1067716|NCT00645099|O2|Outcome|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
1067717|NCT00645099|O1|Outcome|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
1067718|NCT00645099|E2|Reported Event|Olanzapine|10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months
1067719|NCT00645099|E1|Reported Event|Paliperidone ER|6-mg or 9-mg tablet once daily flexible dosing for 6 months
1067720|NCT00645047|B3|Baseline|Total|Total of all reporting groups
1067721|NCT00645047|B2|Baseline|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.~In-Person CBT: In-Person Provision Of Cognitive Therapy"
1067722|NCT00645047|B1|Baseline|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.~Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
1068071|NCT00643916|E5|Reported Event|Vaccinated at Age 18 Months|Participants received Menactra vaccine at 18 months of age
1067723|NCT00645047|P2|Participant Flow|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.~In-Person CBT: In-Person Provision Of Cognitive Therapy"
1067724|NCT00645047|P1|Participant Flow|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.~Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
1067725|NCT00645047|O2|Outcome|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.~In-Person CBT: In-Person Provision Of Cognitive Therapy"
1067726|NCT00645047|O1|Outcome|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.~Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
1067727|NCT00645047|O2|Outcome|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.~In-Person CBT: In-Person Provision Of Cognitive Therapy"
1067728|NCT00645047|O1|Outcome|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.~Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
1067729|NCT00645047|O2|Outcome|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.~In-Person CBT: In-Person Provision Of Cognitive Therapy"
1067730|NCT00645047|O1|Outcome|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.~Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
1067731|NCT00645047|O2|Outcome|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.~In-Person CBT: In-Person Provision Of Cognitive Therapy"
1067732|NCT00645047|O1|Outcome|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.~Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
1067733|NCT00645047|O2|Outcome|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.~In-Person CBT: In-Person Provision Of Cognitive Therapy"
1067734|NCT00645047|O1|Outcome|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.~Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
1067735|NCT00645047|O2|Outcome|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.~In-Person CBT: In-Person Provision Of Cognitive Therapy"
1067736|NCT00645047|O1|Outcome|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.~Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
1067737|NCT00645047|O2|Outcome|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.~In-Person CBT: In-Person Provision Of Cognitive Therapy"
1067738|NCT00645047|O1|Outcome|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.~Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
1067739|NCT00645047|O2|Outcome|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.~In-Person CBT: In-Person Provision Of Cognitive Therapy"
1067740|NCT00645047|O1|Outcome|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.~Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
1067741|NCT00645047|O2|Outcome|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.~In-Person CBT: In-Person Provision Of Cognitive Therapy"
1067742|NCT00645047|O1|Outcome|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.~Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
1067743|NCT00645047|E2|Reported Event|In-Person CBT|"Cognitive behaviour therapy (CBT) delivered using in-person consultation.~In-Person CBT: In-Person Provision Of Cognitive Therapy"
1067744|NCT00645047|E1|Reported Event|Telemedicine CBT|"Cognitive behaviour therapy (CBT) delivered using videoconference telemedicine.~Telemedicine CBT: Use of Videoconfrence Technology To Provide Cognitive Therapy"
1067745|NCT00644995|B3|Baseline|Total|Total of all reporting groups
1067746|NCT00644995|B2|Baseline|Step Up|Proactive phone counseling addressing smoking, depression, and physical activity (PA)
1067747|NCT00644995|B1|Baseline|Usual Care|Advice to quit smoking and referral to standard care
1067748|NCT00644995|P2|Participant Flow|Step Up|proactive phone counseling addressing smoking, depression, and PA
1067749|NCT00644995|P1|Participant Flow|Usual Care|Advice to quit and referral to standard care
1067750|NCT00644995|O2|Outcome|Step Up|Proactive phone counseling addressing smoking, depression, and PA
1067751|NCT00644995|O1|Outcome|Usual Care|Advice to quit and referral to standard care
1067752|NCT00644995|O2|Outcome|Step Up|Proactive phone counseling addressing smoking, depression, and PA
1067753|NCT00644995|O1|Outcome|Usual Care|Advice to quit and referral to standard care
1067754|NCT00644995|O2|Outcome|Step Up|Proactive phone counseling addressing smoking, depression, and PA
1067755|NCT00644995|O1|Outcome|Usual Care|Advice to quit and referral to standard care
1067756|NCT00644995|O2|Outcome|Step Up|Proactive phone counseling addressing smoking, depression, and PA
1067757|NCT00644995|O1|Outcome|Usual Care|Advice to quit and referral to standard care
1067758|NCT00644995|O2|Outcome|Step Up|Proactive phone counseling addressing smoking, depression, and PA
1067759|NCT00644995|O1|Outcome|Usual Care|Advice to quit and referral to standard care
1067760|NCT00644995|O2|Outcome|Step Up|Proactive phone counseling addressing smoking, depression and PA
1067761|NCT00644995|O1|Outcome|Usual Care|Advice to quit and referral to standard care
1067762|NCT00644995|O2|Outcome|Step Up|Proactive phone counseling addressing smoking, depression and physical activity
1067763|NCT00644995|O1|Outcome|Usual Care|Advice to quit and referral to standard care
1067764|NCT00644995|E2|Reported Event|Step Up|Proactive phone counseling addressing smoking, depression, and physical activity
1067765|NCT00644995|E1|Reported Event|Usual Care|Advice to quit and referral to standard care
1067766|NCT00644969|B3|Baseline|Total|Total of all reporting groups
1067767|NCT00644969|B2|Baseline|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
1067768|NCT00644969|B1|Baseline|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
1067769|NCT00644969|P2|Participant Flow|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
1067770|NCT00644969|P1|Participant Flow|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
1067771|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
1067772|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
1067773|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
1067774|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
1067775|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
1067776|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
1067777|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
1067778|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
1067779|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
1067780|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
1067781|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
1067782|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
1067783|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
1067784|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
1067785|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
1067786|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
1067787|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
1067788|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
1067789|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
1067790|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
1067791|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
1067792|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
1067793|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
1067794|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
1067795|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
1067796|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
1067797|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
1067798|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
1067799|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
1067800|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
1067801|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
1067802|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
1067803|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
1067804|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
1067805|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
1068072|NCT00643916|E4|Reported Event|Vaccinated at Age 15 Months|Participants received Menactra vaccine at 15 months of age
1067806|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
1067807|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
1067808|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
1067809|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
1067810|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
1067811|NCT00644969|O2|Outcome|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
1067812|NCT00644969|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
1067813|NCT00644969|E2|Reported Event|Placebo|Placebo (matching study treatment) 0.5 mg QD for 3 days followed by titration to 0.5 mg BID for 4 days, then 1 mg BID up to Week 12.
1067814|NCT00644969|E1|Reported Event|Varenicline|Varenicline 0.5 milligrams (mg) once a day (QD) for 3 days followed by titration to 0.5 mg twice a day (BID) for 4 days, then 1 mg BID up to Week 12.
1067815|NCT00644917|B1|Baseline|Xenaderm vs. Vehicle - Subjects Acted as Own Comparator|Subjects received duplicate 20 mg applications of Xenaderm Ointment and Xenaderm vehicle contained in Finn Chambers, to the left sides of their backs
1067816|NCT00644917|P1|Participant Flow|Xenaderm Ointment - Subjects Acted as Own Comparator|Two 20 mg samples of Xenaderm Ointment and two 20 mg samples of Vehicle were applied in Finn Chambers to four test sites of the left side of each subject's back; a fifth test site was covered with an empty Finn Chamber as a control site
1067817|NCT00644917|O5|Outcome|Xenaderm Vehicle - Non-irradiated|20 mg samples of Xenaderm Vehicle applied in a Finn Chambers to test site the left side of each subject's back - not irradiated
1067818|NCT00644917|O4|Outcome|Xenaderm Ointment - Non-irradiated|20 mg samples of Xenaderm Ointment applied in a Finn Chambers to test site the left side of each subject's back - not irradiated
1067819|NCT00644917|O3|Outcome|Control - Irradiated|test site was covered with an empty Finn Chamber as a control site - then irradiated
1067820|NCT00644917|O2|Outcome|Xenaderm Vehicle - Irradiated|20 mg sample of Vehicle applied in Finn Chamber to test site on the left side of each subject's back - then irradiated
1067821|NCT00644917|O1|Outcome|Xenaderm Ointment - Irradiated|20 mg samples of Xenaderm Ointment applied in a Finn Chambers to test site the left side of each subject's back - then irradiated
1067822|NCT00644917|E1|Reported Event|Xenaderm Ointment - Subjects Acted as Own Comparator|Two 20 mg samples of Xenaderm Ointment and two 20 mg samples of Vehicle were applied in Finn Chambers to four test sites of the left side of each subject's back; a fifth test site was covered with an empty Finn Chamber as a control site
1067823|NCT00644787|B1|Baseline|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
1067824|NCT00644787|P3|Participant Flow|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
1067825|NCT00644787|P2|Participant Flow|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
1067826|NCT00644787|P1|Participant Flow|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
1067827|NCT00644787|O2|Outcome|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
1067828|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
1067829|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
1067830|NCT00644787|O2|Outcome|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
1067831|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
1067832|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
1067833|NCT00644787|O2|Outcome|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
1067834|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
1067835|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
1067836|NCT00644787|O2|Outcome|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
1067837|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
1067838|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
1067839|NCT00644787|O2|Outcome|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
1067840|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
1067841|NCT00644787|O2|Outcome|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
1067842|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
1067843|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
1067890|NCT00644280|E1|Reported Event|Ranibizumab|Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery
1068472|NCT00642694|P1|Participant Flow|Escitalopram + Ramelteon|active augmentation
1067844|NCT00644787|O2|Outcome|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
1067845|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
1067846|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
1067847|NCT00644787|O2|Outcome|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
1067848|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
1067849|NCT00644787|O1|Outcome|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
1067850|NCT00644787|E3|Reported Event|Fentanyl 3-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
1067851|NCT00644787|E2|Reported Event|Fentanyl 1-day Transdermal Patch (Double Blind Phase)|Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
1067852|NCT00644787|E1|Reported Event|Fentanyl 1-day Transdermal Patch (Titration Phase)|Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator’s discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.
1067853|NCT00644657|B1|Baseline|Clopidogrel|All 27 subjects received a 300 mg loading dose of clopidogrel
1067854|NCT00644657|P1|Participant Flow|Clopidogrel Loading Dose|All subjects received a 300 mg loading dose of clopidogrel
1067855|NCT00644657|O1|Outcome|Clopidogrel Loading Dose|All subjects received a 300 mg loading dose of clopidogrel
1067856|NCT00644657|O1|Outcome|Clopidogrel Loading Dose|All subjects received a 300 mg loading dose of clopidogrel
1067857|NCT00644657|E1|Reported Event|Clopidogrel Loading Dose|All subjects received a 300 mg loading dose of clopidogrel
1067858|NCT00644592|B3|Baseline|Total|Total of all reporting groups
1067859|NCT00644592|B2|Baseline|2 Placebo Then Fenofibrate|4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally.
1067860|NCT00644592|B1|Baseline|1-Fenofibrate Then Placebo|4 weeks of drug at 160 mg orally per day
1067861|NCT00644592|P2|Participant Flow|2 Placebo Then Fenofibrate|4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally.
1067862|NCT00644592|P1|Participant Flow|1-Fenofibrate Then Placebo|4 weeks of drug at 160 mg orally per day
1067863|NCT00644592|O2|Outcome|2 Placebo Then Fenofibrate|4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally.
1067864|NCT00644592|O1|Outcome|1-Fenofibrate Then Placebo|4 weeks of drug at 160 mg orally per day
1067865|NCT00644592|E2|Reported Event|2 Placebo|4 weeks of placebo.
1067866|NCT00644592|E1|Reported Event|1-Fenofibrate|4 weeks of drug at 160 mg orally per day
1067867|NCT00644332|B1|Baseline|Ranolazine|In the open-label treatment phase (approximately 4 weeks’ duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
1067868|NCT00644332|P1|Participant Flow|Ranolazine|In the open-label treatment phase (approximately 4 weeks’ duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
1067869|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
1067870|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
1067871|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
1067872|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
1067873|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
1067874|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
1067875|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
1067876|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
1067877|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
1067878|NCT00644332|O1|Outcome|Ranolazine|In the open-label treatment phase (approximately 4 weeks' duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
1067879|NCT00644332|E1|Reported Event|Ranolazine|In the open-label treatment phase (approximately 4 weeks’ duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.
1067880|NCT00644280|B3|Baseline|Total|Total of all reporting groups
1067881|NCT00644280|B2|Baseline|Usual Care|Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
1067882|NCT00644280|B1|Baseline|Ranibizumab|Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery
1067883|NCT00644280|P2|Participant Flow|Usual Care|Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
1067884|NCT00644280|P1|Participant Flow|Ranibizumab|Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery
1067885|NCT00644280|O2|Outcome|Usual Care|Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
1067886|NCT00644280|O1|Outcome|Ranibizumab|Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery
1067887|NCT00644280|O2|Outcome|Usual Care|Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
1067888|NCT00644280|O1|Outcome|Ranibizumab|Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery
1067889|NCT00644280|E2|Reported Event|Usual Care|Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
1067984|NCT00644059|O2|Outcome|TIV-adj (36 to <72 Months)|Subjects aged 36 to < 72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
1067891|NCT00644189|B1|Baseline|Clofarabine Phase I|"Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.~Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles."
1067892|NCT00644189|P4|Participant Flow|Clofarabine: 3 mg|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
1067893|NCT00644189|P3|Participant Flow|Clofarabine 4 mg|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
1067894|NCT00644189|P2|Participant Flow|Clofarabine 2 mg|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
1067895|NCT00644189|P1|Participant Flow|Clofarabine 1 mg|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
1067896|NCT00644189|O1|Outcome|Phase I|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
1067897|NCT00644189|O1|Outcome|Phase I|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
1067898|NCT00644189|O1|Outcome|Phase I|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
1067899|NCT00644189|O1|Outcome|Phase I|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
1067900|NCT00644189|O1|Outcome|Clofarabine|"Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.~Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles."
1067901|NCT00644189|O1|Outcome|Clofarabine|"Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.~Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles."
1067902|NCT00644189|O1|Outcome|Clofarabine|"Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.~Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles."
1067903|NCT00644189|O1|Outcome|Clofarabine|"Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.~Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles."
1067904|NCT00644189|O1|Outcome|Phase I|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
1067905|NCT00644189|O1|Outcome|Phase I-II|Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
1067906|NCT00644189|E1|Reported Event|Clofarabine|"Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.~Clofarabine: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles."
1067907|NCT00644059|B4|Baseline|Total|Total of all reporting groups
1067908|NCT00644059|B3|Baseline|Non-flu Control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
1067909|NCT00644059|B2|Baseline|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
1067910|NCT00644059|B1|Baseline|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
1067911|NCT00644059|P3|Participant Flow|Non-flu Control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of Tick-borne encephalitis (TBE) vaccine
1067912|NCT00644059|P2|Participant Flow|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
1067913|NCT00644059|P1|Participant Flow|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
1067914|NCT00644059|O3|Outcome|Flu-Control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of
1067915|NCT00644059|O2|Outcome|Non-flu Control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
1067916|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
1067917|NCT00644059|O3|Outcome|Flu-Control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
1067918|NCT00644059|O2|Outcome|Non-flu Control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
1067919|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
1067920|NCT00644059|O3|Outcome|Non-flu Control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Novartis meningococcal C conjugate vaccine or tick-borne encephalitis vaccine
1067921|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
1067922|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
1067923|NCT00644059|O3|Outcome|Non-flu-control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
1068473|NCT00642694|O2|Outcome|Escitalopram + Placebo|control group
1067924|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
1067925|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
1067926|NCT00644059|O3|Outcome|Non-flu-control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
1067927|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
1067928|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
1067929|NCT00644059|O3|Outcome|Non-flu-control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
1067930|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
1067931|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
1067932|NCT00644059|O3|Outcome|Non-flu-control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
1067933|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
1067934|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
1067935|NCT00644059|O3|Outcome|Non-flu-control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
1067936|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
1067937|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
1067938|NCT00644059|O3|Outcome|Non-flu-control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
1067939|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
1067940|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
1067941|NCT00644059|O3|Outcome|Non-flu-control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
1067942|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
1067943|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
1067944|NCT00644059|O3|Outcome|Non-flu-control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
1067945|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
1067946|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
1067947|NCT00644059|O3|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
1067948|NCT00644059|O2|Outcome|Non-flu Control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
1067949|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
1067950|NCT00644059|O3|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
1067951|NCT00644059|O2|Outcome|Non-flu Control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
1067952|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
1067953|NCT00644059|O6|Outcome|Flu Control (6 to < 72 Months)|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
1067985|NCT00644059|O1|Outcome|TIV-adj (6 to <36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
1067954|NCT00644059|O5|Outcome|Non-flu Control (6 to <72 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
1067955|NCT00644059|O4|Outcome|TIV-adj (6 to < 72 Months)|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
1067956|NCT00644059|O3|Outcome|Flu-control (6 to < 36 Months)|Subjects aged 6 to <36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
1067957|NCT00644059|O2|Outcome|Non-flu Control (6 to < 36 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
1067958|NCT00644059|O1|Outcome|TIV-adj (6 to < 36 Months)|Subjects aged 6 to <36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
1067959|NCT00644059|O3|Outcome|Non-flu Control|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
1067960|NCT00644059|O2|Outcome|Flu-control|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
1067961|NCT00644059|O1|Outcome|TIV-adj|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
1067962|NCT00644059|O6|Outcome|Flu Control (36 to < 72 Months)|Subjects aged 36 to < 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
1067963|NCT00644059|O5|Outcome|Non-flu Control (36 to < 72 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
1067964|NCT00644059|O4|Outcome|TIV-adj (36 to <72 Months)|Subjects aged 36 to < 72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
1067965|NCT00644059|O3|Outcome|Flu Control (6 to < 36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
1067966|NCT00644059|O2|Outcome|Non-flu Control (6 to < 36 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
1067967|NCT00644059|O1|Outcome|TIV-adj (6 to < 36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
1067968|NCT00644059|O6|Outcome|Flu Control (36 to < 72 Months)|Subjects aged 36 to < 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
1067969|NCT00644059|O5|Outcome|Non-flu Control (36 to <72 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
1067970|NCT00644059|O4|Outcome|TIV-adj (36 to < 72 Months)|Subjects aged 36 to < 72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
1067971|NCT00644059|O3|Outcome|Flu Control (6 to < 36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
1067972|NCT00644059|O2|Outcome|Non-flu Control (6 to <36 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
1067973|NCT00644059|O1|Outcome|TIV-adj (6 to < 36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
1067974|NCT00644059|O6|Outcome|Non-Flu-control (6 to <72 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
1067975|NCT00644059|O5|Outcome|Flu-control (6 to <72 Months)|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
1067976|NCT00644059|O4|Outcome|TIV-adj (6 to <72 Months )|Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
1067977|NCT00644059|O3|Outcome|Non-Flu-control (6 to <36 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
1067978|NCT00644059|O2|Outcome|Flu-control (6 to <36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
1067979|NCT00644059|O1|Outcome|TIV-adj (6 to <36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
1067980|NCT00644059|O6|Outcome|Non-Flu-control (36 to <72 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
1067981|NCT00644059|O5|Outcome|Non-Flu-control (6 to <36 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
1067982|NCT00644059|O4|Outcome|Flu-control (36 to <72 Months)|Subjects aged 36 to < 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
1067983|NCT00644059|O3|Outcome|Flu-control (6 to <36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
1067986|NCT00644059|O2|Outcome|Non-flu Control (6 to <36 Months)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
1067987|NCT00644059|O1|Outcome|TIV-adj (6 to <36 Months)|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
1067988|NCT00644059|O2|Outcome|Flu-control (6 to <36 Months)|Subjects aged 6 to <36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
1067989|NCT00644059|O1|Outcome|TIV-adj (6 to <36 Months)|Subjects aged 6 to <36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
1067990|NCT00644059|E6|Reported Event|Non-Flu-control (TBE Vaccine)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
1067991|NCT00644059|E5|Reported Event|Non-Flu-control (TBE/Men C Vaccine)|Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
1067992|NCT00644059|E4|Reported Event|Flu-control_0.5|Subjects aged 36 to < 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
1067993|NCT00644059|E3|Reported Event|Flu-control_0.25|Subjects aged 6 to < 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
1067994|NCT00644059|E2|Reported Event|TIV-adj_0.5|Subjects aged 36 to < 72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
1067995|NCT00644059|E1|Reported Event|TIV-adj_0.25|Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
1067996|NCT00643201|B3|Baseline|Total|Total of all reporting groups
1067997|NCT00643201|B2|Baseline|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2.~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
1067998|NCT00643201|B1|Baseline|Apixaban|"apixaban: tablets, oral, 10 milligram (mg) tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months.~Placebo for enoxaparin: solution, subcutaneous, 1milligram per kilogram (mg/kg) every 12 hours until sham International normalized ratio (INR) greater than, equal to ( ≥) 2.~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
1067999|NCT00643201|P2|Participant Flow|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2.~Warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
1068000|NCT00643201|P1|Participant Flow|Apixaban|"apixaban: tablets, oral, 10 milligram (mg) tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months.~Placebo for enoxaparin: solution, subcutaneous, 1milligram per kilogram (mg/kg) every 12 hours until sham international normalized ratio (INR) greater than, equal to ( ≥) 2.~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
1068001|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
1068002|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
1068003|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
1068004|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
1068005|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
1068006|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
1068007|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
1068008|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
1068009|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
1068063|NCT00643916|O1|Outcome|Vaccinated at Age 9 and 12 Months|Participants received Menactra vaccine at 9 and 12 months of age
1068064|NCT00643916|O6|Outcome|Vaccinated at Age 3 Years to <6 Years|Participants received Menomune vaccine at age 3 years to <6 years of age
1068010|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
1068011|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
1068012|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
1068013|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
1068014|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
1068015|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
1068016|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
1068017|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
1068018|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
1068019|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
1068020|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
1068021|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
1068022|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
1068023|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
1068024|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
1068025|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
1068026|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
1068027|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
1068028|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
1068029|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
1068030|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
1068065|NCT00643916|O5|Outcome|Vaccinated at Age 18 Months|Participants received Menactra vaccine at 18 months of age
1068031|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
1068032|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
1068033|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
1068034|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2 Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
1068035|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
1068036|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2 Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
1068037|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
1068038|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2.~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
1068039|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
1068040|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
1068041|NCT00643201|O2|Outcome|Enoxaparin + Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
1068042|NCT00643201|O1|Outcome|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2.~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
1068043|NCT00643201|E2|Reported Event|Enoxaparin/Warfarin|"Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months"
1068044|NCT00643201|E1|Reported Event|Apixaban|"Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months"
1068045|NCT00643916|B7|Baseline|Total|Total of all reporting groups
1068046|NCT00643916|B6|Baseline|Vaccinated at Age 3 Years to <6 Years|Participants received Menomune vaccine at age 3 years to <6 years of age
1068047|NCT00643916|B5|Baseline|Vaccinated at Age 18 Months|Participants received Menactra vaccine at 18 months of age
1068048|NCT00643916|B4|Baseline|Vaccinated at Age 15 Months|Participants received Menactra vaccine at 15 months of age
1068049|NCT00643916|B3|Baseline|Vaccinated at Age 12 and 15 Months|Participants received Menactra vaccine at 12 months and 15 months of age
1068050|NCT00643916|B2|Baseline|Vaccinated at Age 9 and 15 Months|Participants received Menactra vaccine at 9 months and 15 months of age
1068051|NCT00643916|B1|Baseline|Vaccinated at Age 9 and 12 Months|Participants received Menactra vaccine at 9 and 12 months of age
1068052|NCT00643916|P6|Participant Flow|Vaccinated at Age 3 Years to <6 Years|Participants received Menomune vaccine at age 3 years to <6 years of age
1068053|NCT00643916|P5|Participant Flow|Vaccinated at Age 18 Months|Participants received Menactra vaccine at 18 months of age
1068054|NCT00643916|P4|Participant Flow|Vaccinated at Age 15 Months|Participants received Menactra vaccine at 15 months of age
1068055|NCT00643916|P3|Participant Flow|Vaccinated at Age 12 and 15 Months|Participants received Menactra vaccine at 12 months and 15 months of age
1068056|NCT00643916|P2|Participant Flow|Vaccinated at Age 9 and 15 Months|Participants received Menactra vaccine at 9 months and 15 months of age
1068057|NCT00643916|P1|Participant Flow|Vaccinated at Age 9 and 12 Months|Participants received Menactra vaccine at 9 and 12 months of age
1068058|NCT00643916|O6|Outcome|Vaccinated at Age 3 Years to <6 Years|Participants received Menomune vaccine at age 3 years to <6 years of age
1068059|NCT00643916|O5|Outcome|Vaccinated at Age 18 Months|Participants received Menactra vaccine at 18 months of age
1068060|NCT00643916|O4|Outcome|Vaccinated at Age 15 Months|Participants received Menactra vaccine at 15 months of age
1068061|NCT00643916|O3|Outcome|Vaccinated at Age 12 and 15 Months|Participants received Menactra vaccine at 12 months and 15 months of age
1068062|NCT00643916|O2|Outcome|Vaccinated at Age 9 and 15 Months|Participants received Menactra vaccine at 9 months and 15 months of age
1068073|NCT00643916|E3|Reported Event|Vaccinated at Age 12 and 15 Months|Participants received Menactra vaccine at 12 months and 15 months of age
1068074|NCT00643916|E2|Reported Event|Vaccinated at Age 9 and 15 Months|Participants received Menactra vaccine at 9 months and 15 months of age
1068075|NCT00643916|E1|Reported Event|Vaccinated at Age 9 and 12 Months|Participants received Menactra vaccine at 9 and 12 months of age
1068076|NCT00643851|B4|Baseline|Total|Total of all reporting groups
1068077|NCT00643851|B3|Baseline|Metformin XR|Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
1068078|NCT00643851|B2|Baseline|Dapagliflozin 5 mg|Dapagliflozin tablets, oral, once daily for 24 weeks
1068079|NCT00643851|B1|Baseline|Dapagliflozin 5 mg + Metformin XR|Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
1068080|NCT00643851|P3|Participant Flow|Metformin XR|Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
1068081|NCT00643851|P2|Participant Flow|Dapagliflozin 5 mg|Dapagliflozin tablets, oral, once daily for 24 weeks
1068082|NCT00643851|P1|Participant Flow|Dapagliflozin 5 mg + Metformin XR|Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
1068083|NCT00643851|O3|Outcome|Metformin XR|Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
1068084|NCT00643851|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin tablets, oral, once daily for 24 weeks
1068085|NCT00643851|O1|Outcome|Dapagliflozin 5 mg + Metformin XR|Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
1068086|NCT00643851|O3|Outcome|Metformin XR|Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
1068087|NCT00643851|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin tablets, oral, once daily for 24 weeks
1068088|NCT00643851|O1|Outcome|Dapagliflozin 5 mg + Metformin XR|Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
1068089|NCT00643851|O3|Outcome|Metformin XR|Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
1068090|NCT00643851|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin tablets, oral, once daily for 24 weeks
1068091|NCT00643851|O1|Outcome|Dapagliflozin 5 mg + Metformin XR|Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
1068092|NCT00643851|O3|Outcome|Metformin XR|Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
1068093|NCT00643851|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin tablets, oral, once daily for 24 weeks
1068094|NCT00643851|O1|Outcome|Dapagliflozin 5 mg + Metformin XR|Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
1068095|NCT00643851|O3|Outcome|Metformin XR|Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
1068096|NCT00643851|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin tablets, oral, once daily for 24 weeks
1068097|NCT00643851|O1|Outcome|Dapagliflozin 5 mg + Metformin XR|Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
1068098|NCT00643851|O3|Outcome|Metformin XR|Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
1068099|NCT00643851|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin tablets, oral, once daily for 24 weeks
1068100|NCT00643851|O1|Outcome|Dapagliflozin 5 mg + Metformin XR|Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
1068101|NCT00643851|E3|Reported Event|Metformin XR|Metfomin XR tablets (500mg up to 2000mg), oral, once daily for 24 weeks
1068102|NCT00643851|E2|Reported Event|Dapagliflozin 5 mg|Dapagliflozin tablets, oral, once daily for 24 weeks
1068103|NCT00643851|E1|Reported Event|Dapagliflozin 5 mg + Metformin XR|Dapagliflozin tablets, oral, once daily for 24 weeks plus metfomin XR tablets (up to 2000mg), oral, once daily for 24 weeks
1068104|NCT00643760|B6|Baseline|Total|Total of all reporting groups
1068105|NCT00643760|B5|Baseline|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
1068106|NCT00643760|B4|Baseline|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068107|NCT00643760|B3|Baseline|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068108|NCT00643760|B2|Baseline|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068109|NCT00643760|B1|Baseline|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
1068110|NCT00643760|P5|Participant Flow|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
1068111|NCT00643760|P4|Participant Flow|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068112|NCT00643760|P3|Participant Flow|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068113|NCT00643760|P2|Participant Flow|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068114|NCT00643760|P1|Participant Flow|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
1068474|NCT00642694|O1|Outcome|Escitalopram + Ramelteon|active augmentation
1068115|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
1068116|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068117|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068118|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068119|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
1068120|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
1068121|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068122|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068123|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068124|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
1068125|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
1068126|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068127|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068128|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068129|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
1068130|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
1068131|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068132|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068133|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068134|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
1068135|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
1068136|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068137|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068138|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068139|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
1068140|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
1068141|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068142|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068171|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068143|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068144|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
1068145|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
1068146|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068147|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068148|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068149|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
1068150|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
1068151|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068152|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068153|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068154|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
1068155|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
1068156|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068157|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068158|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068159|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
1068160|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
1068161|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068162|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068163|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068164|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
1068165|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
1068166|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068167|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068168|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068169|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
1068170|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
1068465|NCT00642707|E3|Reported Event|Arm 3|PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8
1068172|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068173|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068174|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
1068175|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
1068176|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068177|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068178|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068179|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
1068180|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
1068181|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068182|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068183|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068184|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
1068185|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
1068186|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068187|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068188|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068189|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
1068190|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
1068191|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068192|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068193|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068194|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
1068195|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
1068196|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068197|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068198|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068199|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
1068466|NCT00642707|E2|Reported Event|Arm 2|PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15
1068200|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
1068201|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068202|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068203|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068204|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
1068205|NCT00643760|O5|Outcome|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
1068206|NCT00643760|O4|Outcome|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068207|NCT00643760|O3|Outcome|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068208|NCT00643760|O2|Outcome|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068209|NCT00643760|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
1068210|NCT00643760|E5|Reported Event|PGB 300 mg/Day|Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening).
1068211|NCT00643760|E4|Reported Event|GEn 3600 mg/Day|Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068212|NCT00643760|E3|Reported Event|GEn 2400 mg/Day|Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068213|NCT00643760|E2|Reported Event|GEn 1200 mg/Day|One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening).
1068214|NCT00643760|E1|Reported Event|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening).
1068215|NCT00643682|B3|Baseline|Total|Total of all reporting groups
1068216|NCT00643682|B2|Baseline|Control|Patients in this arm will be given the standard pre-endoscopy instructions.
1068217|NCT00643682|B1|Baseline|Educational Card|Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
1068218|NCT00643682|P2|Participant Flow|Control|Patients in this arm will be given the standard pre-endoscopy instructions.
1068219|NCT00643682|P1|Participant Flow|Educational Card|Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
1068220|NCT00643682|O2|Outcome|Control|Patients in this arm will be given the standard pre-endoscopy instructions.
1068221|NCT00643682|O1|Outcome|Educational Card|Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
1068222|NCT00643682|O2|Outcome|Control|Patients in this arm will be given the standard pre-endoscopy instructions.
1068223|NCT00643682|O1|Outcome|Educational Card|Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
1068224|NCT00643682|O2|Outcome|Control|Patients in this arm will be given the standard pre-endoscopy instructions.
1068225|NCT00643682|O1|Outcome|Educational Card|Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
1068226|NCT00643682|O2|Outcome|Control|Patients in this arm will be given the standard pre-endoscopy instructions.
1068227|NCT00643682|O1|Outcome|Educational Card|Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
1068228|NCT00643682|E2|Reported Event|Control|Patients in this arm will be given the standard pre-endoscopy instructions.
1068229|NCT00643682|E1|Reported Event|Educational Card|Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
1068230|NCT00643604|B1|Baseline|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
1068231|NCT00643604|P1|Participant Flow|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
1068232|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
1068233|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
1068234|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
1068235|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
1068236|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
1068237|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
1068238|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
1068239|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
1068240|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
1068241|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
1068242|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
1068243|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
1068244|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
1068245|NCT00643604|O1|Outcome|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
1068246|NCT00643604|E1|Reported Event|Treprostinil Sodium|treprostinil sodium : all subjects underwent a rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
1068247|NCT00643578|B1|Baseline|All Participants|A single dose of 12 mcg and 24 mcg, on separate days, of formoterol were given.
1068248|NCT00643578|P2|Participant Flow|Formoterol 24 First|a single dose of 24 mcg of formoterol was given first, then 12 mcg of formoterol
1068249|NCT00643578|P1|Participant Flow|Formoterol 12 First|a single dose of 12 mcg of formoterol was given first, then 24 mcg of formoterol
1068250|NCT00643578|O2|Outcome|24 Mcg of Formoterol|high dose
1068251|NCT00643578|O1|Outcome|12 Mcg of Formoterol|low dose
1068252|NCT00643578|O2|Outcome|24 Mcg Formoterol|high dose
1068253|NCT00643578|O1|Outcome|12 Mcg Formoterol|low dose
1068254|NCT00643578|E2|Reported Event|Formoterol 24|A single dose of 24 mcg of formoterol was administered.
1068255|NCT00643578|E1|Reported Event|Formoterol 12|A single dose of 12 mcg of formoterol was administered.
1068256|NCT00643565|B3|Baseline|Total|Total of all reporting groups
1068257|NCT00643565|B2|Baseline|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
1068258|NCT00643565|B1|Baseline|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
1068259|NCT00643565|P2|Participant Flow|Bevacizumab + Chemotherapy|Participants received continuous intravenous (IV) infusion of bevacizumab (7.5 milligrams per kilogram [mg/kg] every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
1068260|NCT00643565|P1|Participant Flow|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy i.e. with ifosfamide [I], vincristine [V], actinomycin D [A] and doxorubicin [Do] followed by 5 cycles of IVA-containing chemotherapy [i.e. without doxorubicin]) administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
1068261|NCT00643565|O1|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
1068262|NCT00643565|O1|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
1068263|NCT00643565|O1|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
1068264|NCT00643565|O1|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
1068265|NCT00643565|O2|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
1068266|NCT00643565|O1|Outcome|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
1068267|NCT00643565|O2|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
1068268|NCT00643565|O1|Outcome|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
1068269|NCT00643565|O2|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
1068270|NCT00643565|O1|Outcome|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
1068420|NCT00642811|E7|Reported Event|Clop. Responders/Switching Period: Ticagrelor-Clopidogrel|included responders exposed to ticagrelor switching to clopidogrel on Day 15.
1068271|NCT00643565|O2|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
1068272|NCT00643565|O1|Outcome|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
1068273|NCT00643565|O2|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
1068274|NCT00643565|O1|Outcome|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
1068275|NCT00643565|O2|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
1068276|NCT00643565|O1|Outcome|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
1068277|NCT00643565|O2|Outcome|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
1068278|NCT00643565|O1|Outcome|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
1068279|NCT00643565|E2|Reported Event|Bevacizumab + Chemotherapy|Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
1068306|NCT00643097|B3|Baseline|Arm III (ACT II DI)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
1068280|NCT00643565|E1|Reported Event|Chemotherapy|Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
1068281|NCT00643487|B1|Baseline|All Participants|No new arms or groups were associated with this observational study
1068282|NCT00643487|P1|Participant Flow|All Participants|In order to attempt observation of the behavior of the infrapatellar plica the following protocol was followed: Local anesthesia using bupivicaine was initiated for intra-articular anaesthesia; 1% lidocaine was used for the portals. The IPP, if present will be injected with contrast material. In order to minimize discomfort, lidocaine 1%, in as small a volume as possible, was injected into the fat pad under direct vision to avoid any intra-articular damage from the #25 needle. Radiographic visualization was verified and the knee was taken through a full range of passive and active exercises. Active quadriceps contraction in the subject was performed at 0, 15, 30 60 and 90 degrees of flexion. In so far as is technically possible, the behavior of the IPP was videotaped and recorded on lateral fluoroscopy. The patients underwent completion of the planned procedure, and the normal post-operative course was followed.
1068283|NCT00643487|O1|Outcome|All Participants|In order to attempt observation of the behavior of the infrapatellar plica the following protocol was followed: Local anesthesia using bupivicaine was initiated for intra-articular anaesthesia; 1% lidocaine was used for the portals. The IPP, if present will be injected with contrast material. In order to minimize discomfort, lidocaine 1%, in as small a volume as possible, was injected into the fat pad under direct vision to avoid any intra-articular damage from the #25 needle. Radiographic visualization was verified and the knee was taken through a full range of passive and active exercises. Active quadriceps contraction in the subject was performed at 0, 15, 30 60 and 90 degrees of flexion. In so far as is technically possible, the behavior of the IPP was videotaped and recorded on lateral fluoroscopy. The patients underwent completion of the planned procedure, and the normal post-operative course was followed.
1068284|NCT00643487|E1|Reported Event|All Participants|observation of the behavior of the infrapatellar plica: Local anesthesia using bupivicaine will be initiated. The IPP, if present will be injected with contrast material. In order to minimize discomfort, lidocaine 1%, in as small a volume as possible, will be injected into the fat pad under direct vision to avoid any intra-articular damage from the #25 needle. Radiographic visualization will be verified and the knee taken through a full range of passive and active exercises. Active quadriceps contraction in the subject will be performed at 0, 15, 30 60 and 90 degrees of flexion. In so far as is technically possible, the behavior of the IPP will be videotaped and recorded on lateral fluoroscopy.
1068285|NCT00643448|B4|Baseline|Total|Total of all reporting groups
1068286|NCT00643448|B3|Baseline|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
1068287|NCT00643448|B2|Baseline|AZD1305 Group B|AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
1068288|NCT00643448|B1|Baseline|AZD1305 Group A|AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
1068289|NCT00643448|P3|Participant Flow|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
1068290|NCT00643448|P2|Participant Flow|AZD1305 Group B|AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
1068291|NCT00643448|P1|Participant Flow|AZD1305 Group A|AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
1068292|NCT00643448|O3|Outcome|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
1068293|NCT00643448|O2|Outcome|AZD1305 Group B|AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
1068294|NCT00643448|O1|Outcome|AZD1305 Group A|AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
1068295|NCT00643448|O3|Outcome|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
1068296|NCT00643448|O2|Outcome|AZD1305 Group B|AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
1068297|NCT00643448|O1|Outcome|AZD1305 Group A|AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
1068298|NCT00643448|O2|Outcome|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
1068299|NCT00643448|O1|Outcome|AZD1305 Group A and AZD1305 Group B|AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2 AZD1305 Group B loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
1068300|NCT00643448|O2|Outcome|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
1068301|NCT00643448|O1|Outcome|AZD1305 Group A and AZD1305 Group B|AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2 AZD1305 Group B loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
1068302|NCT00643448|E3|Reported Event|Placebo|Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2
1068303|NCT00643448|E2|Reported Event|AZD1305 Group B|AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
1068304|NCT00643448|E1|Reported Event|AZD1305 Group A|AZD1305 group A loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
1068305|NCT00643097|B4|Baseline|Total|Total of all reporting groups
1068419|NCT00642811|E8|Reported Event|Clop. Responders/Switching Period: Clopidogrel-Ticagrelor|included responders exposed to clopidogrel switching to ticagrelor on Day 15.
1068307|NCT00643097|B2|Baseline|Arm II (ACT II STD)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
1068308|NCT00643097|B1|Baseline|Arm I (ACTIVATE)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
1068309|NCT00643097|P3|Participant Flow|Arm III (ACT II DI)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
1068310|NCT00643097|P2|Participant Flow|Arm II (ACT II STD)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
1068311|NCT00643097|P1|Participant Flow|Arm I (ACTIVATE)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
1068312|NCT00643097|O3|Outcome|Arm III (ACT II DI)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
1068313|NCT00643097|O2|Outcome|Arm II (ACT II STD)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
1068314|NCT00643097|O1|Outcome|Arm I (ACTIVATE)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
1068315|NCT00643097|O3|Outcome|Arm III (ACT II DI)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
1068316|NCT00643097|O2|Outcome|Arm II (ACT II STD)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
1068317|NCT00643097|O1|Outcome|Arm I (ACTIVATE)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
1068318|NCT00643097|O3|Outcome|Arm III (ACT II DI)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
1068319|NCT00643097|O2|Outcome|Arm II (ACT II STD)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
1068320|NCT00643097|O1|Outcome|Arm I (ACTIVATE)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
1068321|NCT00643097|O3|Outcome|Arm III (ACT II DI)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
1068463|NCT00642707|O1|Outcome|Arm 1|PRO 140 - 162 mg for three single SC doses: Days 1, 8, and 15
1068322|NCT00643097|O2|Outcome|Arm II (ACT II STD)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
1068323|NCT00643097|O1|Outcome|Arm I (ACTIVATE)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
1068324|NCT00643097|E3|Reported Event|Arm III (ACT II DI)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 100 mg/m2 for the first 21 days of a 28 day cycle.
1068325|NCT00643097|E2|Reported Event|Arm II (ACT II STD)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) biweekly starting within 6 weeks of completing radiation. Additional vaccinations were given until clinical or radiographic evidence of progression or death. Patients subsequently receive temozolomide at a targeted dose of 200 mg/m2 for the first 5 days of a 28 day cycle.
1068326|NCT00643097|E1|Reported Event|Arm I (ACTIVATE)|Patients first receive 3 initial vaccinations of an epidermal growth factor receptor variant III (EGRRvIII)- specific peptide (PEP-3) keyhole limpet hemocyanin (KLH) conjugate vaccine and sargramostim (GM-CSF) every 2 weeks starting 4 weeks after the completion of radiation. Subsequent vaccinations were given once a month until clinical or radiographic evidence of progression or death.
1068327|NCT00643006|B3|Baseline|Total|Total of all reporting groups
1068328|NCT00643006|B2|Baseline|B. Low-intensive Exercise|Low-to-moderate intensive supervised walks twice a week for 45 minutes during 15 weeks
1068329|NCT00643006|B1|Baseline|A. High Intensive Exercise|High intensive exercise by means of Nordic walking twice a week for 45 minutes during 15 weeks
1068330|NCT00643006|P2|Participant Flow|B. Low-intensive Exercise|Low-to-moderate intensive supervised walks twice a week for 45 minutes during 15 weeks
1068331|NCT00643006|P1|Participant Flow|A. High Intensive Exercise|High intensive exercise by means of Nordic walking twice a week for 45 minutes during 15 weeks
1068332|NCT00643006|O2|Outcome|B. Low-intensive Exercise|Low-to-moderate intensive supervised walks twice a week for 45 minutes during 15 weeks
1068333|NCT00643006|O1|Outcome|A. High Intensive Exercise|High intensive exercise by means of Nordic walking twice a week for 45 minutes during 15 weeks
1068334|NCT00643006|O2|Outcome|Arm B. Active Comparator|The active comparison group participated in low-intensive walks.
1068335|NCT00643006|O1|Outcome|Arm A. Exercise|The intervention group participated in Nordic walking
1068336|NCT00643006|E2|Reported Event|B. Low-intensive Exercise|Low-to-moderate intensive supervised walks twice a week for 45 minutes during 15 weeks
1068337|NCT00643006|E1|Reported Event|A. High Intensive Exercise|High intensive exercise by means of Nordic walking twice a week for 45 minutes during 15 weeks
1068338|NCT00642993|B3|Baseline|Total|Total of all reporting groups
1068339|NCT00642993|B2|Baseline|Placebo|Placebo capsules, administered orally, once daily
1068340|NCT00642993|B1|Baseline|SCH 497079|SCH 497079, administered orally, once daily
1068341|NCT00642993|P2|Participant Flow|Placebo|Placebo capsules, administered orally, once daily
1068342|NCT00642993|P1|Participant Flow|SCH 497079|SCH 497079, administered orally, once daily
1068343|NCT00642993|O2|Outcome|Placebo|Placebo capsules, administered orally, once daily
1068344|NCT00642993|O1|Outcome|SCH 497079|SCH 497079, administered orally, once daily
1068345|NCT00642993|O2|Outcome|Placebo|Placebo capsules, administered orally, once daily
1068346|NCT00642993|O1|Outcome|SCH 497079|SCH 497079, administered orally, once daily
1068347|NCT00642993|O2|Outcome|Placebo|Placebo capsules, administered orally, once daily
1068348|NCT00642993|O1|Outcome|SCH 497079|SCH 497079, administered orally, once daily
1068349|NCT00642993|O2|Outcome|Placebo|Placebo capsules, administered orally, once daily
1068350|NCT00642993|O1|Outcome|SCH 497079|SCH 497079, administered orally, once daily
1068351|NCT00642993|O2|Outcome|Placebo|Placebo capsules, administered orally, once daily
1068352|NCT00642993|O1|Outcome|SCH 497079|SCH 497079, administered orally, once daily
1068353|NCT00642993|E2|Reported Event|Placebo|Placebo capsules, administered orally, once daily
1068354|NCT00642993|E1|Reported Event|SCH 497079|SCH 497079, administered orally, once daily
1068355|NCT00642902|B5|Baseline|Total|Total of all reporting groups
1068356|NCT00642902|B4|Baseline|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
1068357|NCT00642902|B3|Baseline|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
1068358|NCT00642902|B2|Baseline|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
1068359|NCT00642902|B1|Baseline|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
1068360|NCT00642902|P4|Participant Flow|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
1068361|NCT00642902|P3|Participant Flow|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
1068464|NCT00642707|E4|Reported Event|Arm 4|Placebo for three single SC doses: Days 1, 8 and 15
1068362|NCT00642902|P2|Participant Flow|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
1068363|NCT00642902|P1|Participant Flow|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
1068364|NCT00642902|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
1068365|NCT00642902|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
1068366|NCT00642902|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
1068367|NCT00642902|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
1068368|NCT00642902|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
1068369|NCT00642902|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
1068370|NCT00642902|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
1068371|NCT00642902|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
1068372|NCT00642902|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
1068373|NCT00642902|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
1068374|NCT00642902|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
1068375|NCT00642902|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
1068376|NCT00642902|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
1068377|NCT00642902|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
1068378|NCT00642902|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
1068379|NCT00642902|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
1068380|NCT00642902|E4|Reported Event|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
1068381|NCT00642902|E3|Reported Event|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
1068382|NCT00642902|E2|Reported Event|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
1068383|NCT00642902|E1|Reported Event|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
1068384|NCT00642850|B1|Baseline|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
1068385|NCT00642850|P1|Participant Flow|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin (epoetin alfa, epoetin beta or darbepoetin alfa) maintenance treatment, received (after fulfilling all inclusion/exclusion criteria and 4 weeks stability verification period) intravenous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 microgram (mcg) every 4 weeks for 24 weeks.
1068386|NCT00642850|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
1068387|NCT00642850|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
1068388|NCT00642850|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
1068389|NCT00642850|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
1068390|NCT00642850|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
1068391|NCT00642850|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
1068392|NCT00642850|O1|Outcome|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
1068467|NCT00642707|E1|Reported Event|Arm 1|PRO 140 - 162 mg for three single SC doses: Days 1, 8, and 15
1068393|NCT00642850|E1|Reported Event|C.E.R.A.|Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks.
1068394|NCT00642811|B7|Baseline|Total|Total of all reporting groups
1068395|NCT00642811|B6|Baseline|Clopidogrel Responders - Ticagrelor to Ticagrelor|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
1068396|NCT00642811|B5|Baseline|Clopidogrel Responders - Ticagrelor to Clopidogrel|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
1068397|NCT00642811|B4|Baseline|Clopidogrel Responders - Clopidogrel to Ticagrelor|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
1068398|NCT00642811|B3|Baseline|Clopidogrel Responders - Clopidogrel to Clopidogrel|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
1068399|NCT00642811|B2|Baseline|Clopidogrel Non-responders - Ticagrelor to Clopidogrel|Non-responder definition: patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
1068400|NCT00642811|B1|Baseline|Clopidogrel Non-responders - Clopidogrel to Ticagrelor|Non-responder definition: patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
1068401|NCT00642811|P6|Participant Flow|Clopidogrel Responders - Ticagrelor to Ticagrelor|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks; stay on ticagrelor 90 mg twice daily (bd) for 2 weeks.
1068402|NCT00642811|P5|Participant Flow|Clopidogrel Responders - Ticagrelor to Clopidogrel|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks; switch to clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks.
1068403|NCT00642811|P4|Participant Flow|Clopidogrel Responders - Clopidogrel to Ticagrelor|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks; switch to ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks.
1068404|NCT00642811|P3|Participant Flow|Clopidogrel Responders - Clopidogrel to Clopidogrel|Responder definition: patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks; stay on clopidogrel 75 mg once daily (od) for 2 weeks
1068405|NCT00642811|P2|Participant Flow|Clopidogrel Non-responders - Ticagrelor to Clopidogrel|Non-responder definition: patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks; switch to clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks.
1068406|NCT00642811|P1|Participant Flow|Clopidogrel Non-responders - Clopidogrel to Ticagrelor|Non-responder definition: patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist. Clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 2 weeks; switch to ticagrelor 180 mg loading dose followed by 90 mg twice daily (bd) for 2 weeks.
1068407|NCT00642811|O2|Outcome|Responder: Clopidogrel|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
1068408|NCT00642811|O1|Outcome|Responder: Ticagrelor|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
1068409|NCT00642811|O2|Outcome|Responder: Clopidogrel|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
1068410|NCT00642811|O1|Outcome|Responder: Ticagrelor|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
1068411|NCT00642811|O2|Outcome|Responder: Clopidogrel|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
1068412|NCT00642811|O1|Outcome|Responder: Ticagrelor|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
1068413|NCT00642811|O2|Outcome|Responder: Clopidogrel|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
1068414|NCT00642811|O1|Outcome|Responder: Ticagrelor|patients with an absolute difference greater than 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
1068415|NCT00642811|O2|Outcome|Non-responder: Clopidogrel|patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
1068416|NCT00642811|O1|Outcome|Non-responder: Ticagrelor|patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
1068417|NCT00642811|O2|Outcome|Non-responder: Clopidogrel|patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
1068418|NCT00642811|O1|Outcome|Non-responder: Ticagrelor|patients with an absolute difference of less than or equal to 10% between baseline and post-treatment platelet aggregation (maximum extent) with 20 μM ADP used as the agonist
1068421|NCT00642811|E6|Reported Event|Clop. Responders/Non-Switching Period: Clopidogrel|included responders exposed to clopidogrel on Day 1-14, Day 16-28.
1068422|NCT00642811|E5|Reported Event|Clop. Responders/Non-Switching Period: Ticagrelor|included responders exposed to ticagrelor on Day 1-14, Day 16-28.
1068423|NCT00642811|E4|Reported Event|Clop. Non-Responders/Switching Period: Clopidogrel-Ticagrelor|included non-responders exposed to clopidogrel switching to ticagrelor on Day 15.
1068424|NCT00642811|E3|Reported Event|Clop. Non-Responders/Switching Period:Ticagrelor-Clopidogrel|included non-responders exposed to ticagrelor switching to clopidogrel on Day 15.
1068425|NCT00642811|E2|Reported Event|Clopidogrel Non-Responders/Non-Switching Period: Clopidogrel|included non-responders exposed to clopidogrel on Day 1-14, Day 16-28.
1068426|NCT00642811|E1|Reported Event|Clopidogrel Non-Responders/Non-Switching Period: Ticagrelor|included non-responders exposed to ticagrelor on Day 1-14, Day 16-28.
1068427|NCT00642772|B1|Baseline|Group Physical Therapy|"Group Physical Therapy Intervention~Group Physical Therapy: 12-week group-based program of physical therapy. Participants will meet approximately every other week for a total of 6 visits. The group sessions will include education about appropriate self-care for knee osteoarthritis and instructions and participation in group exercises. Participants will also be instructed in a home exercise program."
1068428|NCT00642772|P1|Participant Flow|Group Physical Therapy|"Group Physical Therapy Intervention~Group Physical Therapy: 12-week group-based program of physical therapy. Participants will meet approximately every other week for a total of 6 visits. The group sessions will include education about appropriate self-care for knee osteoarthritis and instructions and participation in group exercises. Participants will also be instructed in a home exercise program."
1068429|NCT00642772|O1|Outcome|Group Physical Therapy|"Group Physical Therapy Intervention~Group Physical Therapy: 12-week group-based program of physical therapy. Participants will meet approximately every other week for a total of 6 visits. The group sessions will include education about appropriate self-care for knee osteoarthritis and instructions and participation in group exercises. Participants will also be instructed in a home exercise program."
1068430|NCT00642772|E1|Reported Event|Group Physical Therapy|"Group Physical Therapy Intervention~Group Physical Therapy: 12-week group-based program of physical therapy. Participants will meet approximately every other week for a total of 6 visits. The group sessions will include education about appropriate self-care for knee osteoarthritis and instructions and participation in group exercises. Participants will also be instructed in a home exercise program."
1068431|NCT00642759|B1|Baseline|Chemotherapy|"carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles~Abraxane: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles~Bevacizumab"
1068432|NCT00642759|P1|Participant Flow|Chemotherapy|"carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles~Abraxane: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles~Bevacizumab"
1068433|NCT00642759|O1|Outcome|Chemotherapy|"Carboplatin, nab-paclitaxel, and bevacizumab~carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles~Nab-paclitaxel: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles~Bevacizumab: IV infusion"
1068434|NCT00642759|O1|Outcome|Chemotherapy|"Carboplatin, nab-paclitaxel, and bevacizumab~carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles~Nab-paclitaxel: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles~Bevacizumab: IV infusion"
1068435|NCT00642759|O1|Outcome|Chemotherapy|"Carboplatin, nab-paclitaxel, and bevacizumab~carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles~Nab-paclitaxel: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles~Bevacizumab: IV infusion"
1068436|NCT00642759|O1|Outcome|Chemotherapy|"carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles~Abraxane: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles~Bevacizumab"
1068437|NCT00642759|E1|Reported Event|Chemotherapy|"carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles~Abraxane: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles~Bevacizumab"
1068438|NCT00642746|B3|Baseline|Total|Total of all reporting groups
1068439|NCT00642746|B2|Baseline|FOLFOX With Erlotinib|
1068440|NCT00642746|B1|Baseline|FOLFIRI With Erlotinib|
1068441|NCT00642746|P2|Participant Flow|FOLFOX With Erlotinib|
1068442|NCT00642746|P1|Participant Flow|FOLFIRI With Erlotinib|
1068443|NCT00642746|O2|Outcome|FOLFOX With Erlotinib|
1068444|NCT00642746|O1|Outcome|FOLFIRI With Erlotinib|
1068445|NCT00642746|O2|Outcome|FOLFOX With Erlotinib|
1068446|NCT00642746|O1|Outcome|FOLFIRI With Erlotinib|
1068447|NCT00642746|O2|Outcome|FOLFOX With Erlotinib|
1068448|NCT00642746|O1|Outcome|FOLFIRI With Erlotinib|
1068449|NCT00642746|E2|Reported Event|FOLFOX With Erlotinib|
1068450|NCT00642746|E1|Reported Event|FOLFIRI With Erlotinib|
1068451|NCT00642707|B5|Baseline|Total|Total of all reporting groups
1068452|NCT00642707|B4|Baseline|Arm 4|Placebo for three single SC doses: Days 1, 8 and 15
1068453|NCT00642707|B3|Baseline|Arm 3|PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8
1068454|NCT00642707|B2|Baseline|Arm 2|PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15
1068455|NCT00642707|B1|Baseline|Arm 1|PRO 140 - 162 mg for three single SC doses: Days 1, 8, and 15
1068456|NCT00642707|P4|Participant Flow|Arm 4|Placebo for three single SC doses: Days 1, 8 and 15
1068457|NCT00642707|P3|Participant Flow|Arm 3|PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8
1068458|NCT00642707|P2|Participant Flow|Arm 2|PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15
1068459|NCT00642707|P1|Participant Flow|Arm 1|PRO 140 - 162 mg for three single SC doses: Days 1, 8, and 15
1068460|NCT00642707|O4|Outcome|Arm 4|Placebo for three single SC doses: Days 1, 8 and 15
1068461|NCT00642707|O3|Outcome|Arm 3|PRO 140 - 324 mg for two single SC doses: Days 1 and 15 plus one SC dose of placebo at Day 8
1068462|NCT00642707|O2|Outcome|Arm 2|PRO 140 - 324 mg for three single SC doses: Days 1, 8 and 15
1068468|NCT00642694|B3|Baseline|Total|Total of all reporting groups
1068477|NCT00642694|E2|Reported Event|Escitalopram + Placebo|Placebo augmentation
1068478|NCT00642694|E1|Reported Event|Escitalopram + Ramelteon|active augmentation
1068479|NCT00642668|B1|Baseline|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.~methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
1068480|NCT00642668|P1|Participant Flow|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.~methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
1068481|NCT00642668|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.~methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
1068482|NCT00642668|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.~methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
1068483|NCT00642668|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.~methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
1068484|NCT00642668|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.~methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
1068485|NCT00642668|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.~methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
1068486|NCT00642668|E1|Reported Event|Methoxy Polyethylene Glycol-Epoetin Beta|"Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.~methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)"
1068487|NCT00642642|B1|Baseline|Autologous Fibroblasts and Placebo|Patients were treated with autologous fibroblasts on one cheek, and placebo on the opposite cheek
1068488|NCT00642642|P1|Participant Flow|Autologous Fibroblasts and Placebo|Patients were treated with autologous fibroblasts on one cheek, and placebo on the opposite cheek
1068489|NCT00642642|O2|Outcome|Placebo Cheeks|Cheeks randomized to receive placebo treatment
1068490|NCT00642642|O1|Outcome|Autologous Fibroblast Cheeks|Cheeks randomized to receive autologous fibroblast treatment
1068491|NCT00642642|O2|Outcome|Placebo Cheeks|Cheeks treated with placebo solution
1068492|NCT00642642|O1|Outcome|Autologous Fibroblasts Cheeks|Cheeks treated with autologous fibroblasts (azficel-T)
1068493|NCT00642642|O2|Outcome|Placebo Cheeks|Cheeks treated with placebo solution
1068494|NCT00642642|O1|Outcome|Autologous Fibroblast Cheeks|Cheeks treated with autologous fibroblasts
1068495|NCT00642642|O2|Outcome|Placebo Cheeks|Cheeks treated with placebo solution
1068496|NCT00642642|O1|Outcome|Autologous Fibroblasts Cheeks|Cheeks treated with autologous fibroblasts (azficel-T)
1068497|NCT00642642|E3|Reported Event|Non-treatment Area Adverse Events|Systemic adverse events and adverse events that occured outside of the study treatment area will be reported in this group
1068498|NCT00642642|E2|Reported Event|Placebo Cheeks|Cheeks randomized to receive placebo treatment
1068499|NCT00642642|E1|Reported Event|Autologous Fibroblast Cheeks|Cheeks randomized to receive autologous fibroblast treatment
1068500|NCT00642616|B5|Baseline|Total|Total of all reporting groups
1068501|NCT00642616|B4|Baseline|Usual Care (COPD)|Usual and anti diabetic care in diabetic participants with COPD.
1068502|NCT00642616|B3|Baseline|Technosphere® Insulin (COPD)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic patients with COPD
1068503|NCT00642616|B2|Baseline|Usual Care (Asthma)|Usual and anti diabetic care in diabetic participants with Asthma.
1068504|NCT00642616|B1|Baseline|Technosphere® Insulin (Asthma)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic patients with Asthma
1068505|NCT00642616|P4|Participant Flow|Usual Care (COPD)|Usual and anti diabetic care in diabetic participants with Chronic Obstructive Pulmonary disease (COPD)
1068506|NCT00642616|P3|Participant Flow|Technosphere® Insulin (COPD)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Chronic Obstructive Pulmonary disease (COPD)
1068507|NCT00642616|P2|Participant Flow|Usual Care (Asthma)|Usual and anti diabetic care in diabetic participants with Asthma.
1068508|NCT00642616|P1|Participant Flow|Technosphere® Insulin (Asthma)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
1068509|NCT00642616|O4|Outcome|Usual Care (COPD)|Usual and anti diabetic care in diabetic participants with COPD
1068510|NCT00642616|O3|Outcome|Technosphere® Insulin (COPD)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with COPD
1068511|NCT00642616|O2|Outcome|Usual Care (Asthma)|Usual and anti diabetic care in diabetic participants with Asthma.
1068512|NCT00642616|O1|Outcome|Technosphere® Insulin (Asthma)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
1068513|NCT00642616|O4|Outcome|Usual Care With Anti-diabetic Agents (COPD)|Usual anti diabetic care in diabetic participants with COPD
1068514|NCT00642616|O3|Outcome|Technosphere® Insulin (COPD)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with COPD
1068515|NCT00642616|O2|Outcome|Usual Care With Anti-diabetic Agents (Asthma)|Usual anti diabetic care in diabetic participants with Asthma
1068516|NCT00642616|O1|Outcome|Technosphere® Insulin (Asthma)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
1068517|NCT00642616|O4|Outcome|Usual Care With Anti-diabetic Agents (COPD)|Usual anti diabetic care in diabetic participants with COPD
1068518|NCT00642616|O3|Outcome|Technosphere® Insulin (COPD)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with COPD
1068519|NCT00642616|O2|Outcome|Usual Care With Anti-diabetic Agents (Asthma)|Usual anti diabetic care in diabetic participants with Asthma
1068520|NCT00642616|O1|Outcome|Technosphere® Insulin (Asthma)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
1068521|NCT00642616|O4|Outcome|Usual Care (COPD)|Usual and anti diabetic care in diabetic participants with COPD
1068522|NCT00642616|O3|Outcome|Technosphere® Insulin (COPD)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with COPD
1068523|NCT00642616|O2|Outcome|Usual Care (Asthma)|Usual and anti diabetic care in diabetic participants with Asthma.
1068524|NCT00642616|O1|Outcome|Technosphere® Insulin (Asthma)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
1068525|NCT00642616|E4|Reported Event|Usual Care With Anti-diabetic Agents (COPD)|Usual anti diabetic care in diabetic participants with COPD
1068526|NCT00642616|E3|Reported Event|Technosphere® Insulin (COPD)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with COPD
1068527|NCT00642616|E2|Reported Event|Usual Care With Anti-diabetic Agents (Asthma)|Usual anti diabetic care in diabetic participants with Asthma
1068528|NCT00642616|E1|Reported Event|Technosphere® Insulin (Asthma)|Technosphere® Insulin Inhalation Powder in combination with an antidiabetic regimen in diabetic participants with Asthma
1068529|NCT00642603|B3|Baseline|Total|Total of all reporting groups
1068530|NCT00642603|B2|Baseline|XELIRI + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cycle, and irinotecan intravenously at a dose of 135 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
1068531|NCT00642603|B1|Baseline|XELOX + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cylce, and oxaliplatin intravenously at a dose of 85 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
1068532|NCT00642603|P2|Participant Flow|XELIRI + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cycle, and irinotecan intravenously at a dose of 135 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
1068533|NCT00642603|P1|Participant Flow|XELOX + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cylce, and oxaliplatin intravenously at a dose of 85 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
1068534|NCT00642603|O2|Outcome|XELIRI + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cycle, and irinotecan intravenously at a dose of 135 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
1068535|NCT00642603|O1|Outcome|XELOX + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cylce, and oxaliplatin intravenously at a dose of 85 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
1068536|NCT00642603|E2|Reported Event|XELIRI + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cycle, and irinotecan intravenously at a dose of 135 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
1068537|NCT00642603|E1|Reported Event|XELOX + Bevacizumab (Q2W)|Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cylce, and oxaliplatin intravenously at a dose of 85 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
1068538|NCT00642473|B3|Baseline|Total|Total of all reporting groups
1068539|NCT00642473|B2|Baseline|Treatment (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the treatment of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).
1068540|NCT00642473|B1|Baseline|Prevention (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated the same day as the start of erlotinib. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the prevention of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).
1068541|NCT00642473|P2|Participant Flow|Treatment (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the treatment of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).
1068542|NCT00642473|P1|Participant Flow|Prevention (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 milligrams (mg) orally daily. Metronidazole actavis treatment was initiated the same day as the start of erlotinib. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the prevention of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).
1068543|NCT00642473|O4|Outcome|Right Side - Treatment (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the treatment of erlotinib associated rash.
1068544|NCT00642473|O3|Outcome|Left Side - Treatment (Erlotinib + Standard Procedures)|Participants received erlotinib 150 mg orally daily for 4 weeks. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream) to evaluate whether it was effective in the treatment of erlotinib associated rash.
1068545|NCT00642473|O2|Outcome|Right Side - Prevention (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the prevention of erlotinib associated rash.
1068546|NCT00642473|O1|Outcome|Left Side - Prevention (Erlotinib + Standard Procedures)|Participants received erlotinib 150 mg orally daily for 4 weeks. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream) to evaluate whether it was effective in the prevention of erlotinib associated rash.
1068547|NCT00642473|O4|Outcome|Right Side - Treatment (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the treatment of erlotinib associated rash.
1068548|NCT00642473|O3|Outcome|Left Side - Treatment (Erlotinib + Standard Procedures)|Participants received erlotinib 150 mg orally daily for 4 weeks. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream) to evaluate whether it was effective in the treatment of erlotinib associated rash.
1068549|NCT00642473|O2|Outcome|Right Side - Prevention (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the prevention of erlotinib associated rash.
1068550|NCT00642473|O1|Outcome|Left Side - Prevention (Erlotinib + Standard Procedures)|Participants received erlotinib 150 mg orally daily for 4 weeks. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream) to evaluate whether it was effective in the prevention of erlotinib associated rash .
1068551|NCT00642473|E2|Reported Event|Treatment (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated when participants developed rash. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the treatment of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).
1068552|NCT00642473|E1|Reported Event|Prevention (Erlotinib + Metronidazole Actavis)|Participants received erlotinib 150 mg orally daily. Metronidazole actavis treatment was initiated the same day as the start of erlotinib. Metronidazole actavis 1% topical cream was applied on the right side of the face and chest twice daily for 4 weeks to evaluate whether it was effective in the prevention of erlotinib associated rash. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream).
1068553|NCT00642460|B3|Baseline|Total|Total of all reporting groups
1068554|NCT00642460|B2|Baseline|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068555|NCT00642460|B1|Baseline|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate and corticosteroids if applicable."
1068556|NCT00642460|P6|Participant Flow|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068557|NCT00642460|P5|Participant Flow|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068558|NCT00642460|P4|Participant Flow|Tocilizumab Switchers|"Tocilizumab Switchers includes all participants who changed their dose either Tocilizumab 8 mg/kg or 12 mg/kg intravenous (iv) every 2 weeks in Part II.~Participants remained on their prescribed standard of care treatment with non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate and corticosteroids if applicable."
1068559|NCT00642460|P3|Participant Flow|Placebo|Placebo iv every 2 weeks for 12 weeks in Part 1. Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
1068560|NCT00642460|P2|Participant Flow|Tocilizumab_12 mg/kg|"Tocilizumab 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part I and every 2 weeks for 92 weeks in Part II.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068561|NCT00642460|P1|Participant Flow|Tocilizumab_8 mg/kg|"Tocilizumab 8 mg/kg (for patients ≥30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part I and every 2 weeks for 92 weeks in Part II.~Participants remained on their prescribed standard of care treatment with non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate and corticosteroids if applicable."
1069659|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
1068562|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068563|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068564|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068565|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068566|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068567|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068568|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068569|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068570|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068571|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068572|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068573|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068574|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068575|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068576|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068577|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068578|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068579|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068580|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068581|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068582|NCT00642460|O1|Outcome|All Participants Treated With Tocilizumab|"Tocilizumab either 8 mg/kg (participants ≥ 30 kg) or 12 mg/kg (participants <30 kg) iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068583|NCT00642460|O2|Outcome|Participants <30 kg|"Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1069004|NCT00640614|O3|Outcome|Methyldibrono-glutaronitrile|Number of subjects who exhibit reactions 7-10 days after application
1068584|NCT00642460|O1|Outcome|Participants ≥30 kg|"Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068585|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068586|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068587|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068588|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068589|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068590|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068591|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068592|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068593|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068594|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068595|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068596|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068597|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068598|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068599|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068600|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068601|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068602|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068603|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068604|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068605|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068606|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068607|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068608|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1069701|NCT00639379|O1|Outcome|Senofilcon A Toric|
1069702|NCT00639379|O2|Outcome|Alphafilcon A Toric|
1068609|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068610|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068611|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068612|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068613|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068614|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068615|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068616|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068617|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068618|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068619|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068620|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068621|NCT00642460|O2|Outcome|Placebo|"Placebo iv every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068622|NCT00642460|O1|Outcome|Tocilizumab|"Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.~Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable."
1068623|NCT00642460|E1|Reported Event|All Tocilizumab (Part I, Part II and Part III)|Tocilizumab either 8 mg/kg (participants ≥ 30 kg) or 12 mg/kg (participants <30 kg) iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
1068624|NCT00642369|B3|Baseline|Total|Total of all reporting groups
1068625|NCT00642369|B2|Baseline|Haloperidol|haloperidol treatment (6-40mg/day) in 28 days
1068626|NCT00642369|B1|Baseline|Quetiapine Fumarate|quetiapine fumarate treatment (200-750mg/day) in 28 days
1068627|NCT00642369|P2|Participant Flow|Haloperidol|slow wave sleep% in haloperidol treatment group
1068628|NCT00642369|P1|Participant Flow|Quetiapine Fumarate|slow wave sleep% and rapid eye movement sleepin quetiapine fumarate treatment group
1068629|NCT00642369|O2|Outcome|Haloperidol|percentage of rapid eye movement sleep in haloperidol group
1068630|NCT00642369|O1|Outcome|Quetiapine Fumarate|percentage of rapid eye movement sleep in quetiapine fumarate group
1068631|NCT00642369|O2|Outcome|Haloperidol|percentage of slow wave sleep in haloperidol group
1068632|NCT00642369|O1|Outcome|Quetiapine Fumarate|percentage of slow wave sleep in quetiapine fumarate group
1068633|NCT00642369|E2|Reported Event|Haloperidol|haloperidol treatment (6-40mg/day) in 28 days
1068634|NCT00642369|E1|Reported Event|Quetiapine Fumarate|quetiapine fumarate treatment (200-750mg/day) in 28 days
1068635|NCT00642356|B3|Baseline|Total|Total of all reporting groups
1068636|NCT00642356|B2|Baseline|Immediate Release Carbidopa/Levodopa|Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
1068637|NCT00642356|B1|Baseline|Carbidopa/Levodopa/Entacapone|Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
1068638|NCT00642356|P2|Participant Flow|Immediate Release Carbidopa/Levodopa|Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
1068639|NCT00642356|P1|Participant Flow|Carbidopa/Levodopa/Entacapone|Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
1068640|NCT00642356|O2|Outcome|Immediate Release Carbidopa/Levodopa|Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
1069005|NCT00640614|O2|Outcome|Hydrocortisone-17-Butyrate|Number of subjects who exhibit reactions 7-10 days after application
1068641|NCT00642356|O1|Outcome|Carbidopa/Levodopa/Entacapone|Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
1068642|NCT00642356|O2|Outcome|Immediate Release Carbidopa/Levodopa|Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
1068643|NCT00642356|O1|Outcome|Carbidopa/Levodopa/Entacapone|Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
1068644|NCT00642356|E2|Reported Event|Immediate Release Carbidopa/Levodopa|Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.
1068645|NCT00642356|E1|Reported Event|Carbidopa/Levodopa/Entacapone|Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
1068646|NCT00642304|B1|Baseline|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
1068647|NCT00642304|P1|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously (SC) every four weeks up to Week 20. The starting dose was 120, 200 or 300 micrograms (mcg) based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the hemoglobin (Hb) levels.
1068648|NCT00642304|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
1068649|NCT00642304|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
1068650|NCT00642304|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
1068651|NCT00642304|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
1068652|NCT00642304|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
1068653|NCT00642304|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
1068654|NCT00642304|E1|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
1068655|NCT00642278|B8|Baseline|Total|Total of all reporting groups
1068656|NCT00642278|B7|Baseline|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068657|NCT00642278|B6|Baseline|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
1068658|NCT00642278|B5|Baseline|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068659|NCT00642278|B4|Baseline|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068660|NCT00642278|B3|Baseline|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068661|NCT00642278|B2|Baseline|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068662|NCT00642278|B1|Baseline|Placebo|Each patient received matching placebo twice daily for 12 weeks.
1068663|NCT00642278|P7|Participant Flow|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068664|NCT00642278|P6|Participant Flow|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
1068665|NCT00642278|P5|Participant Flow|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1069703|NCT00639379|O1|Outcome|Senofilcon A Toric|
1068666|NCT00642278|P4|Participant Flow|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068667|NCT00642278|P3|Participant Flow|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068668|NCT00642278|P2|Participant Flow|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068669|NCT00642278|P1|Participant Flow|Placebo|Each patient received matching placebo twice daily for 12 weeks.
1068670|NCT00642278|O7|Outcome|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068671|NCT00642278|O6|Outcome|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
1068672|NCT00642278|O5|Outcome|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068673|NCT00642278|O4|Outcome|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068674|NCT00642278|O3|Outcome|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068675|NCT00642278|O2|Outcome|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068676|NCT00642278|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 12 weeks.
1068677|NCT00642278|O7|Outcome|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068678|NCT00642278|O6|Outcome|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
1068679|NCT00642278|O5|Outcome|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068680|NCT00642278|O4|Outcome|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068681|NCT00642278|O3|Outcome|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068682|NCT00642278|O2|Outcome|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068683|NCT00642278|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 12 weeks.
1068684|NCT00642278|O7|Outcome|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068685|NCT00642278|O6|Outcome|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
1068686|NCT00642278|O5|Outcome|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068687|NCT00642278|O4|Outcome|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068688|NCT00642278|O3|Outcome|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068689|NCT00642278|O2|Outcome|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068690|NCT00642278|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 12 weeks.
1068691|NCT00642278|O7|Outcome|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068692|NCT00642278|O6|Outcome|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
1068693|NCT00642278|O5|Outcome|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068694|NCT00642278|O4|Outcome|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068695|NCT00642278|O3|Outcome|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068696|NCT00642278|O2|Outcome|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068697|NCT00642278|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 12 weeks.
1068698|NCT00642278|O7|Outcome|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068699|NCT00642278|O6|Outcome|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
1068700|NCT00642278|O5|Outcome|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068701|NCT00642278|O4|Outcome|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068702|NCT00642278|O3|Outcome|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1069704|NCT00639379|O2|Outcome|Alphafilcon A Toric|
1068703|NCT00642278|O2|Outcome|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068704|NCT00642278|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 12 weeks.
1068705|NCT00642278|O7|Outcome|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068706|NCT00642278|O6|Outcome|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
1068707|NCT00642278|O5|Outcome|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068708|NCT00642278|O4|Outcome|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068709|NCT00642278|O3|Outcome|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068710|NCT00642278|O2|Outcome|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068711|NCT00642278|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 12 weeks.
1068712|NCT00642278|E7|Reported Event|Sitagliptin 100 mg Daily|Each patient received 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068713|NCT00642278|E6|Reported Event|Canagliflozin 300 mg Twice Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
1068714|NCT00642278|E5|Reported Event|Canagliflozin 300 mg Daily|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068715|NCT00642278|E4|Reported Event|Canagliflozin 200 mg Daily|Each patient received 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068716|NCT00642278|E3|Reported Event|Canagliflozin 100 mg Daily|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068717|NCT00642278|E2|Reported Event|Canagliflozin 50 mg Daily|Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
1068718|NCT00642278|E1|Reported Event|Placebo|Each patient received matching placebo twice daily for 12 weeks.
1068719|NCT00642174|B3|Baseline|Total|Total of all reporting groups
1068720|NCT00642174|B2|Baseline|Clopidogrel Then Prasugrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose. Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
1068721|NCT00642174|B1|Baseline|Prasugrel Then Clopidogrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose. Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
1068722|NCT00642174|P2|Participant Flow|Clopidogrel Then Prasugrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose. Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
1068723|NCT00642174|P1|Participant Flow|Prasugrel Then Clopidogrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose. Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
1068724|NCT00642174|O2|Outcome|Clopidogrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
1068725|NCT00642174|O1|Outcome|Prasugrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
1068726|NCT00642174|O2|Outcome|Clopidogrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
1068727|NCT00642174|O1|Outcome|Prasugrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
1068728|NCT00642174|O2|Outcome|Clopidogrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
1068729|NCT00642174|O1|Outcome|Prasugrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
1068730|NCT00642174|O2|Outcome|Clopidogrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
1068731|NCT00642174|O1|Outcome|Prasugrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
1068732|NCT00642174|O2|Outcome|Clopidogrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
1068733|NCT00642174|O1|Outcome|Prasugrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
1068734|NCT00642174|E2|Reported Event|Clopidogrel|Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
1068735|NCT00642174|E1|Reported Event|Prasugrel|Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
1068736|NCT00641862|B3|Baseline|Total|Total of all reporting groups
1068737|NCT00641862|B2|Baseline|Placebo|"Placebo~Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery"
1068738|NCT00641862|B1|Baseline|Vitamin B12|"Vitamin B12~Vitamin B12: Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery"
1068739|NCT00641862|P2|Participant Flow|Placebo|"Placebo~Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery"
1068740|NCT00641862|P1|Participant Flow|Vitamin B12|"Vitamin B12~Vitamin B12: Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery"
1068741|NCT00641862|O2|Outcome|Placebo|"Placebo~Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery"
1068742|NCT00641862|O1|Outcome|Vitamin B12|"Vitamin B12~Vitamin B12: Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery"
1068743|NCT00641862|E2|Reported Event|Placebo|"Placebo~Placebo: Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery"
1068744|NCT00641862|E1|Reported Event|Vitamin B12|"Vitamin B12~Vitamin B12: Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery"
1068745|NCT00641745|B3|Baseline|Total|Total of all reporting groups
1068746|NCT00641745|B2|Baseline|Risperidone|Risperidone 2 mg tablets (2-6 mg/day) flexibly dosed
1068747|NCT00641745|B1|Baseline|Lurasidone|Lurasidone 40 mg tablets (flexibly dosed): 40-120 mg/day
1068748|NCT00641745|P2|Participant Flow|Risperidone|Risperidone 2 mg tablets (2-6 mg/day) flexibly dosed
1068749|NCT00641745|P1|Participant Flow|Lurasidone|Lurasidone 40 mg tablets (flexibly dosed): 40-120 mg/day
1068750|NCT00641745|O2|Outcome|Risperidone|Risperidone 2 mg tablets (2-6 mg/day) flexibly dosed
1068751|NCT00641745|O1|Outcome|Lurasidone|Lurasidone 40 mg tablets (flexibly dosed): 40-120 mg/day
1068752|NCT00641745|E2|Reported Event|Risperidone|Risperidone 2 mg tablets (2-6 mg/day) flexibly dosed
1068753|NCT00641745|E1|Reported Event|Lurasidone|Lurasidone 40 mg tablets (flexibly dosed): 40-120 mg/day
1068754|NCT00641719|B3|Baseline|Total|Total of all reporting groups
1068755|NCT00641719|B2|Baseline|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
1068756|NCT00641719|B1|Baseline|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
1068757|NCT00641719|P2|Participant Flow|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
1068758|NCT00641719|P1|Participant Flow|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
1068759|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
1068760|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
1068761|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
1068762|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
1068763|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
1068764|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
1068765|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
1068766|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
1068767|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
1068768|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
1068769|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
1068770|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
1068771|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
1068772|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
1068773|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
1068774|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
1068775|NCT00641719|O2|Outcome|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
1068776|NCT00641719|O1|Outcome|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
1068777|NCT00641719|E2|Reported Event|Duloxetine 60 mg|Duloxetine 60 mg QD, PO, 1 year
1068778|NCT00641719|E1|Reported Event|Duloxetine 40 mg|Duloxetine 40 mg once daily (QD), orally (PO), 1 year
1068779|NCT00641706|B3|Baseline|Total|Total of all reporting groups
1068780|NCT00641706|B2|Baseline|Arm B (Undergoing Surgery)|"Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.~surgery : Patient undergoes therapeutic conventional surgery~bortezomib : Given IV~vorinostat : Given orally"
1068781|NCT00641706|B1|Baseline|Arm A (Not Undergoing Surgery)|"Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~bortezomib : Given IV~vorinostat : Given orally"
1068782|NCT00641706|P2|Participant Flow|Arm B (Undergoing Surgery)|"Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.~surgery : Patient undergoes therapeutic conventional surgery~bortezomib : Given IV~vorinostat : Given orally"
1068783|NCT00641706|P1|Participant Flow|Arm A (Not Undergoing Surgery)|"Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~bortezomib : Given IV~vorinostat : Given orally"
1068784|NCT00641706|O2|Outcome|Arm B (Undergoing Surgery)|"Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.~surgery : Patient undergoes therapeutic conventional surgery bortezomib : Given IV vorinostat : Given orally"
1068785|NCT00641706|O1|Outcome|Arm A (Not Undergoing Surgery)|"Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~bortezomib : Given IV~vorinostat : Given orally"
1068874|NCT00641537|E8|Reported Event|Cladribine 5.25 mg/kg/No Treatment|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
1068786|NCT00641706|O2|Outcome|Arm B (Undergoing Surgery)|"Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.~surgery : Patient undergoes therapeutic conventional surgery bortezomib : Given IV vorinostat : Given orally"
1068787|NCT00641706|O1|Outcome|Arm A (Not Undergoing Surgery)|"Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~bortezomib : Given IV~vorinostat : Given orally"
1068788|NCT00641706|O2|Outcome|Arm B (Undergoing Surgery)|"Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.~surgery : Patient undergoes therapeutic conventional surgery bortezomib : Given IV vorinostat : Given orally"
1068789|NCT00641706|O1|Outcome|Arm A (Not Undergoing Surgery)|"Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~bortezomib : Given IV~vorinostat : Given orally"
1068790|NCT00641706|O2|Outcome|Arm B (Undergoing Surgery)|"Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.~surgery : Patient undergoes therapeutic conventional surgery bortezomib : Given IV vorinostat : Given orally"
1068791|NCT00641706|O1|Outcome|Arm A (Not Undergoing Surgery)|"Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~bortezomib : Given IV~vorinostat : Given orally"
1068792|NCT00641706|E2|Reported Event|Arm B (Undergoing Surgery)|vorinostat : Given orally
1068793|NCT00641706|E1|Reported Event|Arm A (Not Undergoing Surgery)|vorinostat : Given orally
1068794|NCT00641667|B1|Baseline|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
1068795|NCT00641667|P1|Participant Flow|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
1068796|NCT00641667|O1|Outcome|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
1068797|NCT00641667|O1|Outcome|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
1068798|NCT00641667|O1|Outcome|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
1068799|NCT00641667|O1|Outcome|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
1068800|NCT00641667|O1|Outcome|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
1068801|NCT00641667|O1|Outcome|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
1068802|NCT00641667|O1|Outcome|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
1068876|NCT00641537|E6|Reported Event|Placebo/No Treatment|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
1068803|NCT00641667|E1|Reported Event|Fentanyl|Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator’s discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
1068804|NCT00641641|B1|Baseline|Drug Intervention|Tenofovir+emtricitabine+raltegravir
1068805|NCT00641641|P1|Participant Flow|Drug Intervention|Tenofovir+emtricitabine+raltegravir
1068806|NCT00641641|O1|Outcome|Drug Intervention|Tenofovir+emtricitabine+raltegravir
1068807|NCT00641641|E1|Reported Event|Drug Intervention|Tenofovir+emtricitabine+raltegravir
1068808|NCT00641563|B1|Baseline|All Study Participants|Both arms combined
1068809|NCT00641563|P2|Participant Flow|Mida/Remi Followed by Dex/Remi|Sedation with midazolam and remifentanil followed by sedation with dexmedetomidine and remifentanil separated by one week
1068810|NCT00641563|P1|Participant Flow|Dex/Remi Followed by Mida/Remi|Sedation with dexmedetomidine and remifentanil followed by sedation with midazolam and remifentanil separated by one week
1068811|NCT00641563|O2|Outcome|Mida/Remi|Sedation with midazolam and remifentanil
1068812|NCT00641563|O1|Outcome|Dex/Remi|Sedation with dexmedetomidine and remifentanil
1068813|NCT00641563|O2|Outcome|Mida/Remi|Sedation with midazolam and remifentanil
1068814|NCT00641563|O1|Outcome|Dex/Remi|Sedation with dexmedetomidine and remifentanil
1068815|NCT00641563|E2|Reported Event|Mida/Remi Followed by Dex/Remi|Sedation with midazolam and remifentanil followed by sedation with dexmedetomidine and remifentanil separated by one week
1068816|NCT00641563|E1|Reported Event|Dex/Remi|Sedation with dexmedetomidine and remifentanil
1068817|NCT00641537|B6|Baseline|Total|Total of all reporting groups
1068818|NCT00641537|B5|Baseline|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068819|NCT00641537|B4|Baseline|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068820|NCT00641537|B3|Baseline|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068821|NCT00641537|B2|Baseline|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068822|NCT00641537|B1|Baseline|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068823|NCT00641537|P8|Participant Flow|Cladribine 5.25 mg/kg/No Treatment|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
1068824|NCT00641537|P7|Participant Flow|Cladribine 3.5 mg/kg/No Treatment|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
1068825|NCT00641537|P6|Participant Flow|Placebo/No Treatment|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
1068826|NCT00641537|P5|Participant Flow|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068827|NCT00641537|P4|Participant Flow|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068875|NCT00641537|E7|Reported Event|Cladribine 3.5 mg/kg/No Treatment|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
1068828|NCT00641537|P3|Participant Flow|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068829|NCT00641537|P2|Participant Flow|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068830|NCT00641537|P1|Participant Flow|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068831|NCT00641537|O5|Outcome|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068832|NCT00641537|O4|Outcome|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068833|NCT00641537|O3|Outcome|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068834|NCT00641537|O2|Outcome|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068835|NCT00641537|O1|Outcome|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068836|NCT00641537|O5|Outcome|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068837|NCT00641537|O4|Outcome|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068838|NCT00641537|O3|Outcome|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068839|NCT00641537|O2|Outcome|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068840|NCT00641537|O1|Outcome|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068841|NCT00641537|O5|Outcome|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068941|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
1069705|NCT00639379|O1|Outcome|Senofilcon A Toric|
1068842|NCT00641537|O4|Outcome|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068843|NCT00641537|O3|Outcome|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068844|NCT00641537|O2|Outcome|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068845|NCT00641537|O1|Outcome|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068846|NCT00641537|O5|Outcome|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068847|NCT00641537|O4|Outcome|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068848|NCT00641537|O3|Outcome|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068849|NCT00641537|O2|Outcome|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068850|NCT00641537|O1|Outcome|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068851|NCT00641537|O5|Outcome|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068852|NCT00641537|O4|Outcome|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068853|NCT00641537|O3|Outcome|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068854|NCT00641537|O2|Outcome|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068855|NCT00641537|O1|Outcome|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068942|NCT00641043|E2|Reported Event|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
1069006|NCT00640614|O1|Outcome|Gold Sodium Thiosulfate|Number of subjects who exhibit reactions 7-10 days after application
1068856|NCT00641537|O5|Outcome|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068857|NCT00641537|O4|Outcome|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068858|NCT00641537|O3|Outcome|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068859|NCT00641537|O2|Outcome|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068860|NCT00641537|O1|Outcome|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068861|NCT00641537|O5|Outcome|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068862|NCT00641537|O4|Outcome|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068863|NCT00641537|O3|Outcome|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068864|NCT00641537|O2|Outcome|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068865|NCT00641537|O1|Outcome|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068866|NCT00641537|E16|Reported Event|Cladribine 5.25 mg/kg/No Treatment (24-week Follow-up Period)|Participants who received no cladribine treatment during 96 weeks were followed up for 24 weeks in supplemental follow-up period.
1068867|NCT00641537|E15|Reported Event|Cladribine 3.5 mg/kg/No Treatment (24-week Follow-up Period)|Participants who received no cladribine treatment during 96 weeks were followed up for 24 weeks in supplemental follow-up period.
1068868|NCT00641537|E14|Reported Event|Placebo/No Treatment (24-week Follow-up Period)|Participants who received no cladribine treatment during 96 weeks were followed up for 24-Week supplemental follow-up period.
1068869|NCT00641537|E13|Reported Event|Placebo/Cladribine Low Dose (PPLL) (24-week Follow-up Period)|Participants who received cladribine 3.5 mg/kg during the treatment period of 96 weeks were followed up for 24 weeks in supplemental follow-up period.
1068870|NCT00641537|E12|Reported Event|Cladribine High/Low Dose (HLLL) (24-week Follow-up Period)|Participants who received cladribine 3.5 mg/kg during the treatment period of 96 weeks were followed up for 24 weeks in supplemental follow-up period.
1068871|NCT00641537|E11|Reported Event|Cladribine Low/Low Dose (LLLL) (24-week Follow-up Period)|Participants who received cladribine 3.5 mg/kg during the treatment period of 96 weeks were followed up for 24 weeks in supplemental follow-up period.
1068872|NCT00641537|E10|Reported Event|Cladribine High Dose/Placebo (HLPP) (24-week Follow-up Period|Participants who received placebo matched to cladribine tablet during the treatment period of 96 weeks were followed up for 24 weeks in supplemental follow-up period.
1068873|NCT00641537|E9|Reported Event|Cladribine Low/Placebo (LLPP) (24-week Follow-up Period)|Participants who received placebo matched to cladribine tablet during the treatment period of 96 weeks were followed up for 24 weeks in supplemental follow-up period.
1068943|NCT00641043|E1|Reported Event|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
1069168|NCT00640341|O3|Outcome|O2Optix|Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
1068877|NCT00641537|E5|Reported Event|Placebo/Cladribine Low Dose (PPLL)|Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received Cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068878|NCT00641537|E4|Reported Event|Cladribine High/Low Dose (HLLL)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068879|NCT00641537|E3|Reported Event|Cladribine Low/Low Dose (LLLL)|Participants who received Cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068880|NCT00641537|E2|Reported Event|Cladribine High Dose/Placebo (HLPP)|Participants who received Cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068881|NCT00641537|E1|Reported Event|Cladribine Low/Placebo (LLPP)|Participants who received cladribine 3.5 milligram/kilogram (mg/kg) in previous study 25643 (NCT00213135) and completed were re-randomized in this extension study and received placebo matched to cladribine tablet 0.875 mg/kg orally over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in supplemental follow-up period.
1068882|NCT00641056|B3|Baseline|Total|Total of all reporting groups
1068883|NCT00641056|B2|Baseline|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
1068884|NCT00641056|B1|Baseline|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
1068885|NCT00641056|P2|Participant Flow|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
1068886|NCT00641056|P1|Participant Flow|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
1068887|NCT00641056|O4|Outcome|Insulin Glargine No SU|Patients assigned to the Insulin Glargine No SU group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L and took concomitant Met only.
1068888|NCT00641056|O3|Outcome|Exenatide Once Weekly No SU|Patients assigned to the Exenatide Once Weekly No SU group received a 2 mg dose of exenatide injected once a week and took concomitant Met only.
1068889|NCT00641056|O2|Outcome|Insulin Glargine With SU|Patients assigned to the Insulin Glargine with SU group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L and took concomitant Met+SU.
1068890|NCT00641056|O1|Outcome|Exenatide Once Weekly With SU|Patients assigned to the Exenatide Once Weekly With SU group received a 2 mg dose of exenatide injected once a week and took concomitant Met+SU.
1068891|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
1068892|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
1068893|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
1068894|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
1068895|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
1068896|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
1068897|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
1068898|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
1068899|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
1068900|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
1068901|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
1068902|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
1068903|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
1068904|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
1068905|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
1068906|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
1068907|NCT00641056|O2|Outcome|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
1068908|NCT00641056|O1|Outcome|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
1068909|NCT00641056|E2|Reported Event|Insulin Glargine|Patients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.
1068910|NCT00641056|E1|Reported Event|Exenatide Once Weekly|Patients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.
1068911|NCT00641043|B3|Baseline|Total|Total of all reporting groups
1068912|NCT00641043|B2|Baseline|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
1068913|NCT00641043|B1|Baseline|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
1068914|NCT00641043|P2|Participant Flow|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
1068915|NCT00641043|P1|Participant Flow|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
1068916|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
1068917|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
1068918|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
1068919|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
1068920|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
1068921|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
1068922|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
1068923|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
1068924|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
1068925|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
1068926|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
1068927|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
1068928|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
1068929|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
1068930|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
1068931|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
1068932|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
1068933|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
1068934|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
1068935|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
1068936|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
1068937|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
1068938|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
1068939|NCT00641043|O1|Outcome|Placebo + Pioglitazone|Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
1068940|NCT00641043|O2|Outcome|Linagliptin + Pioglitazone|Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
1068944|NCT00640978|B1|Baseline|Erlotinib + RAD001|Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks
1068945|NCT00640978|P1|Participant Flow|Erlotinib + RAD001|Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks
1068946|NCT00640978|O1|Outcome|Erlotinib + RAD001|Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks
1068947|NCT00640978|E1|Reported Event|Erlotinib + RAD001|Erlotinib 150 mg orally daily for 28 Days + RAD001 (Everolimus) 30 mg orally weekly for 4 Weeks
1068948|NCT00640926|B4|Baseline|Total|Total of all reporting groups
1068949|NCT00640926|B3|Baseline|Radezolid 450 mg PO Twice Daily (BID)|
1068950|NCT00640926|B2|Baseline|Radezolid 450 mg PO Daily (QD)|
1068951|NCT00640926|B1|Baseline|Radezolid 300 mg PO Daily (QD)|
1068952|NCT00640926|P3|Participant Flow|Radezolid 450 mg PO Twice Daily (BID)|
1068953|NCT00640926|P2|Participant Flow|Radezolid 450 mg PO Daily (QD)|
1068954|NCT00640926|P1|Participant Flow|Radezolid 300 mg PO Daily (QD)|
1068955|NCT00640926|O3|Outcome|Radezolid 450 mg PO Twice Daily (BID)|
1068956|NCT00640926|O2|Outcome|Radezolid 450 mg PO Daily (QD)|
1068957|NCT00640926|O1|Outcome|Radezolid 300 mg PO Daily (QD)|
1068958|NCT00640926|O3|Outcome|Radezolid 450 mg PO Twice Daily (BID)|
1068959|NCT00640926|O2|Outcome|Radezolid 450 mg PO Daily (QD)|
1068960|NCT00640926|O1|Outcome|Radezolid 300 mg PO Daily (QD)|
1068961|NCT00640926|E3|Reported Event|Radezolid 450 mg PO Twice Daily (BID)|
1068962|NCT00640926|E2|Reported Event|Radezolid 450 mg PO Daily (QD)|
1068963|NCT00640926|E1|Reported Event|Radezolid 300 mg PO Daily (QD)|
1068964|NCT00640835|B3|Baseline|Total|Total of all reporting groups
1068965|NCT00640835|B2|Baseline|Buprenorphine/Naloxone Film Strip Administered Buccally|
1068966|NCT00640835|B1|Baseline|Buprenorphine/Naloxone Film Strip Administered Sublingually|
1068967|NCT00640835|P2|Participant Flow|Buprenorphine/Naloxone Film Strip Administered Buccally|
1068968|NCT00640835|P1|Participant Flow|Buprenorphine/Naloxone Film Strip Administered Sublingually|
1068969|NCT00640835|O2|Outcome|Buprenorphine/Naloxone Film Strip Administered Buccally|
1068970|NCT00640835|O1|Outcome|Buprenorphine/Naloxone Film Strip Administered Sublingually|
1068971|NCT00640835|O2|Outcome|Buprenorphine/Naloxone Film Strip Administered Buccally|
1068972|NCT00640835|O1|Outcome|Buprenorphine/Naloxone Film Strip Administered Sublingually|
1068973|NCT00640835|E2|Reported Event|Buprenorphine/Naloxone Film Strip Administered Buccally|
1068974|NCT00640835|E1|Reported Event|Buprenorphine/Naloxone Film Strip Administered Sublingually|
1068975|NCT00640822|B4|Baseline|Total|Total of all reporting groups
1068976|NCT00640822|B3|Baseline|Calcipotriol Plus Hydrocortisone Ointment Vehicle|Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks
1068977|NCT00640822|B2|Baseline|Tacalcitol Ointment|Tacalcitol once daily for up to 8 weeks
1068978|NCT00640822|B1|Baseline|Calcipotriol Plus Hydrocortisone Ointment|Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks
1068979|NCT00640822|P3|Participant Flow|Calcipotriol Plus Hydrocortisone Ointment Vehicle|Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks
1068980|NCT00640822|P2|Participant Flow|Tacalcitol Ointment|Tacalcitol once daily for up to 8 weeks
1068981|NCT00640822|P1|Participant Flow|Calcipotriol Plus Hydrocortisone Ointment|Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks
1068982|NCT00640822|O3|Outcome|Calcipotriol Plus Hydrocortisone Ointment Vehicle|Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks
1068983|NCT00640822|O2|Outcome|Tacalcitol Ointment|Tacalcitol once daily for up to 8 weeks
1068984|NCT00640822|O1|Outcome|Calcipotriol Plus Hydrocortisone Ointment|Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks
1068985|NCT00640822|E3|Reported Event|Calcipotriol Plus Hydrocortisone Ointment Vehicle|Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks
1068986|NCT00640822|E2|Reported Event|Tacalcitol Ointment|Tacalcitol once daily for up to 8 weeks
1068987|NCT00640822|E1|Reported Event|Calcipotriol Plus Hydrocortisone Ointment|Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks
1068988|NCT00640614|B3|Baseline|Total|Total of all reporting groups
1068989|NCT00640614|B2|Baseline|Consecutives|Subjects who are being seen for standard allergy patch testing, that are asked to participate in the study.
1068990|NCT00640614|B1|Baseline|Sensitives|Subjects with a clinical history and positive patch test (current or previous) to any of the seven allergens. Subjects must otherwise be healthy and fulfill entry criteria.
1068991|NCT00640614|P2|Participant Flow|Consecutives|Subjects who are being seen for standard allergy patch testing, that are asked to participate in the study.
1068992|NCT00640614|P1|Participant Flow|Sensitives|Subjects with a clinical history and positive patch test (current or previous) to any of the seven allergens. Subjects must otherwise be healthy and fulfill entry criteria.
1068993|NCT00640614|O7|Outcome|Bronopol|Number of subjects who exhibit reactions 7-10 days after application
1068994|NCT00640614|O6|Outcome|Disperse Blue|Number of subjects who exhibit reactions 7-10 days after application
1068995|NCT00640614|O5|Outcome|Parthenolide|Number of subjects who exhibit reactions 7-10 days after application
1068996|NCT00640614|O4|Outcome|Bacitracin|Number of subjects who exhibit reactions 7-10 days after application
1068997|NCT00640614|O3|Outcome|Methyldibrono-glutaronitrile|Number of subjects who exhibit reactions 7-10 days after application
1068998|NCT00640614|O2|Outcome|Hydrocortisone-17-Butyrate|Number of subjects who exhibit reactions 7-10 days after application
1068999|NCT00640614|O1|Outcome|Gold Sodium Thiosulfate|Number of subjects who exhibit reactions 7-10 days after application
1069000|NCT00640614|O7|Outcome|Bronopol|Number of subjects who exhibit reactions 7-10 days after application
1069001|NCT00640614|O6|Outcome|Disperse Blue|Number of subjects who exhibit reactions 7-10 days after application
1069002|NCT00640614|O5|Outcome|Parthenolide|Number of subjects who exhibit reactions 7-10 days after application
1069003|NCT00640614|O4|Outcome|Bacitracin|Number of subjects who exhibit reactions 7-10 days after application
1069007|NCT00640614|O3|Outcome|Adhesion|Number of subjects whose patches had little to no skin to panel contact prior to removal at visit 2.
1069008|NCT00640614|O2|Outcome|Itching and Burning|Subject reported sensations of itching and burning were captured at day 2 following patch removal
1069009|NCT00640614|O1|Outcome|Panel Irritation|Irritation from the test panel adhesive and/or tape was scored at day 2 following patch removal
1069010|NCT00640614|O2|Outcome|Specificity|The agreement between negative results for bronopol and the reference allergen
1069011|NCT00640614|O1|Outcome|Sensitivity|The agreement between positive results for bronopol and reference allergen
1069012|NCT00640614|O2|Outcome|Specificity|The agreement between negative results for disperse blue and the reference allergen
1069013|NCT00640614|O1|Outcome|Sensitivity|The agreement between positive results for disperse blue and the reference allergen
1069014|NCT00640614|O2|Outcome|Specificity|The agreement between negative results for parthenolide and the reference allergen
1069015|NCT00640614|O1|Outcome|Sensitivity|The agreement between positive results for parthenolide and reference allergen
1069016|NCT00640614|O2|Outcome|Specificity|The agreement between the negative results for bacitracin and the reference allergen
1069017|NCT00640614|O1|Outcome|Sensitivity|The agreement between positive results for bacitracin and reference allergen
1069018|NCT00640614|O2|Outcome|Specificity|The agreement between the negative results for methyldibromo-glutaronitrile and the reference allergen
1069019|NCT00640614|O1|Outcome|Sensitivity|The agreement between positive results for methyldibromo-glutaronitrile and reference allergen
1069020|NCT00640614|O2|Outcome|Specificity|The agreement between negative results for hydrocortisone-17-butyrate and the reference allergen
1069021|NCT00640614|O1|Outcome|Sensitivity|The agreement between positive results for hydrocortisone-17-butyrate and reference allergen
1069022|NCT00640614|O2|Outcome|Specificity|The agreement between the negative results for gold sodium thiosulfate and the reference allergen
1069023|NCT00640614|O1|Outcome|Sensitivity|The agreement between positive results for gold sodium thiosulfate and reference allergen
1069024|NCT00640614|O1|Outcome|Concordance|Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.
1069025|NCT00640614|O1|Outcome|Concordance|Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.
1069026|NCT00640614|O1|Outcome|Concordance|Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.
1069027|NCT00640614|O1|Outcome|Concordance|Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.
1069028|NCT00640614|O1|Outcome|Concordance|Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.
1069029|NCT00640614|O1|Outcome|Concordance|Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.
1069030|NCT00640614|O1|Outcome|Concordance|Percentage of sensitive subjects (per allergen) whose patch test responses were concordant with the reference allergen.
1069031|NCT00640614|E2|Reported Event|Consecutives|Subjects who are being seen for standard allergy patch testing, that are asked to participate in the study.
1069032|NCT00640614|E1|Reported Event|Sensitives|Subjects with a clinical history and positive patch test (current or previous) to any of the seven allergens. Subjects must otherwise be healthy and fulfill entry criteria.
1069033|NCT00640601|B1|Baseline|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
1069034|NCT00640601|P1|Participant Flow|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
1069035|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
1069036|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
1069037|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
1069038|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
1069039|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
1069123|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
1069124|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
1069040|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
1069041|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
1069042|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
1069043|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
1069044|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
1069045|NCT00640601|O1|Outcome|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
1069046|NCT00640601|E1|Reported Event|Seroquel XR|Open-label seroquel XR tablets: On Day 1 Patients received 300 mg, on Day 2 600 mg, on Day 3 600-800 mg and between Day 4-168 400-800 mg Seroquel XR, according to clinical judgement of investigator. Dose changes were in 200 mg fixed doses. Investigational product (IP) was supplied in open label wallet blister cards and subjects were instructed to take the IP once daily in the evening.
1069047|NCT00640562|B3|Baseline|Total|Total of all reporting groups
1069048|NCT00640562|B2|Baseline|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
1069049|NCT00640562|B1|Baseline|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
1069050|NCT00640562|P2|Participant Flow|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
1069051|NCT00640562|P1|Participant Flow|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
1069052|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
1069053|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
1069054|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
1069055|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
1069056|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
1069125|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
1069706|NCT00639379|O2|Outcome|Alphafilcon A Toric|
1069057|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
1069058|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
1069059|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
1069060|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
1069061|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
1069062|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
1069063|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
1069064|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
1069065|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
1069066|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
1069067|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
1069068|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
1069069|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
1069070|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
1069071|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
1069072|NCT00640562|O2|Outcome|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
1069167|NCT00640341|O1|Outcome|PureVision|Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.
1069073|NCT00640562|O1|Outcome|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
1069074|NCT00640562|E2|Reported Event|Risperidone|Risperidone dose was uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
1069075|NCT00640562|E1|Reported Event|Seroquel XR|Seroquel XR dose uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
1069076|NCT00640510|B3|Baseline|Total|Total of all reporting groups
1069077|NCT00640510|B2|Baseline|IM Placebo|Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
1069078|NCT00640510|B1|Baseline|IM Olanzapine 10mg|Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
1069079|NCT00640510|P2|Participant Flow|IM Placebo|Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
1069080|NCT00640510|P1|Participant Flow|IM Olanzapine 10mg|Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
1069081|NCT00640510|O2|Outcome|IM Placebo|Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
1069082|NCT00640510|O1|Outcome|IM Olanzapine 10mg|Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
1069083|NCT00640510|O2|Outcome|IM Placebo|Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
1069084|NCT00640510|O1|Outcome|IM Olanzapine 10mg|Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
1069085|NCT00640510|O2|Outcome|IM Placebo|Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
1069086|NCT00640510|O1|Outcome|IM Olanzapine 10mg|Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
1069087|NCT00640510|O2|Outcome|IM Placebo|Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
1069088|NCT00640510|O1|Outcome|IM Olanzapine 10mg|Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
1069089|NCT00640510|E2|Reported Event|IM Placebo|Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
1069090|NCT00640510|E1|Reported Event|IM Olanzapine 10mg|Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
1069091|NCT00640393|B1|Baseline|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
1069092|NCT00640393|P3|Participant Flow|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
1069093|NCT00640393|P2|Participant Flow|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
1069094|NCT00640393|P1|Participant Flow|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
1069095|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
1069096|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
1069097|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
1069098|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
1069099|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
1069100|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
1069101|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
1069102|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
1069103|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
1069104|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
1069105|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
1069106|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
1069107|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
1069108|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
1069109|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
1069110|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
1069111|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
1069112|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
1069113|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
1069114|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
1069115|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
1069116|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
1069117|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
1069118|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
1069119|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
1069120|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
1069121|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
1069122|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
1069707|NCT00639379|O1|Outcome|Senofilcon A Toric|
1069708|NCT00639379|O2|Outcome|Alphafilcon A Toric|
1069126|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
1069127|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
1069128|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
1069129|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
1069130|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
1069131|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
1069132|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
1069133|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
1069134|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
1069135|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
1069136|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
1069137|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
1069138|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
1069139|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
1069140|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
1069141|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
1069142|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
1069143|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
1069144|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
1069145|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
1069146|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
1069147|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
1069148|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
1069149|NCT00640393|O3|Outcome|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
1069150|NCT00640393|O2|Outcome|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
1069151|NCT00640393|O1|Outcome|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
1069152|NCT00640393|E3|Reported Event|Part 2 - Etanercept|Participants who did not reach PASI-90 after 12 weeks were randomized to the Entercept group. They received 50 mg Etanercept once per a week.
1069153|NCT00640393|E2|Reported Event|Part 2 - Etanercept and nbUVB|Participants who did not reach PASI-90 after 12 weeks and were randomized to the nbUVB group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week.
1069154|NCT00640393|E1|Reported Event|Part 1 - Etanercept|All participants received etanercept 50 mg twice a week for 12 weeks.
1069155|NCT00640341|B4|Baseline|Total|Total of all reporting groups
1069156|NCT00640341|B3|Baseline|O2Optix|Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
1069157|NCT00640341|B2|Baseline|Acuvue Oasys|Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.
1069158|NCT00640341|B1|Baseline|PureVision|Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.
1069159|NCT00640341|P3|Participant Flow|O2Optix|Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
1069160|NCT00640341|P2|Participant Flow|Acuvue Oasys|Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.
1069161|NCT00640341|P1|Participant Flow|PureVision|Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.
1069162|NCT00640341|O3|Outcome|O2Optix|Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
1069163|NCT00640341|O2|Outcome|Acuvue Oasys|Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.
1069164|NCT00640341|O1|Outcome|PureVision|Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.
1069165|NCT00640341|O3|Outcome|O2Optix|Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
1069166|NCT00640341|O2|Outcome|Acuvue Oasys|Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.
1069169|NCT00640341|O2|Outcome|Acuvue Oasys|Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.
1069170|NCT00640341|O1|Outcome|PureVision|Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.
1069171|NCT00640341|E3|Reported Event|O2Optix|Currently marketed O2Optix Contact Lens. Lenses are to be worn on a daily wear basis.
1069172|NCT00640341|E2|Reported Event|Acuvue Oasys|Currently marketed Acuvue Oasys Contact Lens. Lenses are to be worn on a daily wear basis.
1069173|NCT00640341|E1|Reported Event|PureVision|Redesigned PureVision Contact Lens. Lenses are to be worn on a daily wear basis.
1069174|NCT00640328|B7|Baseline|Total|Total of all reporting groups
1069175|NCT00640328|B6|Baseline|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
1069176|NCT00640328|B5|Baseline|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
1069177|NCT00640328|B4|Baseline|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
1069178|NCT00640328|B3|Baseline|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
1069179|NCT00640328|B2|Baseline|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
1069180|NCT00640328|B1|Baseline|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
1069181|NCT00640328|P6|Participant Flow|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069182|NCT00640328|P5|Participant Flow|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069183|NCT00640328|P4|Participant Flow|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069184|NCT00640328|P3|Participant Flow|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069185|NCT00640328|P2|Participant Flow|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069186|NCT00640328|P1|Participant Flow|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069187|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
1069709|NCT00639379|O1|Outcome|Senofilcon A Toric|
1069188|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
1069189|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
1069190|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
1069191|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
1069192|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
1069193|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
1069194|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
1069195|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
1069196|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
1069197|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
1069198|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
1069199|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
1069200|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
1069201|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
1069202|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
1069203|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
1069204|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
1069205|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
1069256|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
1069206|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
1069207|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
1069208|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
1069209|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
1069210|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
1069211|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
1069212|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
1069213|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
1069214|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
1069215|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
1069216|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
1069217|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
1069218|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
1069219|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
1069220|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
1069221|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
1069222|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
1069223|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
1069363|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069724|NCT00639158|B2|Baseline|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
1069224|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
1069225|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
1069226|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
1069227|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
1069228|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
1069229|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
1069230|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
1069231|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
1069232|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
1069233|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
1069234|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
1069235|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069236|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069237|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069238|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069257|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
1069725|NCT00639158|B1|Baseline|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
1069239|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069240|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069241|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
1069242|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
1069243|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
1069244|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
1069245|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
1069246|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
1069247|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
1069248|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
1069249|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
1069250|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
1069251|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
1069252|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
1069253|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
1069254|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
1069255|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
1069726|NCT00639158|P2|Participant Flow|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
1069258|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
1069259|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period.
1069260|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
1069261|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
1069262|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period.
1069263|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose.
1069264|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose.
1069265|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069266|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069267|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069268|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069269|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069270|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069271|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069364|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069272|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069273|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069274|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069275|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069276|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069277|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069278|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before consideAfter completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.ring progression to the 700 mg dose.
1069279|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069280|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069281|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069282|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069365|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069366|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069283|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069284|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069285|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069286|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069287|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069288|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069289|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069290|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069291|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069292|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069293|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069316|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069294|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069295|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069296|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069297|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069298|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069299|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069300|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069301|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069302|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069303|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069304|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069355|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069356|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069513|NCT00640016|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069305|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069306|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069307|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069308|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069309|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069310|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069311|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069312|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069313|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069314|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069315|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069357|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069358|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069317|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069318|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069319|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069320|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069321|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069322|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069323|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069324|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069325|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069326|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069327|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069359|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069360|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069328|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069329|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069330|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069331|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069332|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069333|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069334|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069335|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069336|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069337|NCT00640328|O6|Outcome|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069338|NCT00640328|O5|Outcome|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069361|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069362|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069727|NCT00639158|P1|Participant Flow|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
1069339|NCT00640328|O4|Outcome|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069340|NCT00640328|O3|Outcome|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069341|NCT00640328|O2|Outcome|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069342|NCT00640328|O1|Outcome|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069343|NCT00640328|E6|Reported Event|Matching Placebo/700 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069344|NCT00640328|E5|Reported Event|Matching Placebo/300 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069345|NCT00640328|E4|Reported Event|Matching Placebo/100 mg Ofa|Matching placebo was administered as two iv infusions separated by 2 wks during the first 24-wk treatment period. Ofa was administered as two doses of 100 mg via iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069346|NCT00640328|E3|Reported Event|700 mg Ofa/Matching Placebo|Ofa was administered as two doses of 700 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069347|NCT00640328|E2|Reported Event|300 mg Ofa/Matching Placebo|Ofa was administered as two doses of 300 mg via iv infusions separated by 2 wks during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An IDMC evaluated the safety data at Week 4 for participants receiving the 300 mg dose before considering progression to the 700 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069348|NCT00640328|E1|Reported Event|100 Milligrams (mg) Ofatumumab (Ofa)/Matching Placebo|Ofa was administered as two doses of 100 mg via intravenous (iv) infusions separated by 2 weeks (wks) during the first 24-wk treatment period. Matching placebo was administered as two iv infusions separated by 2 wks during the second 24-wk treatment period. An Independent Data Monitoring Committee (IDMC) evaluated the safety data at Week 4 for participants receiving the 100 mg dose before considering progression to the 300 mg dose. After completing Week 48 of the second treatment period or withdrawing from the study for any reason, participants entered an Individualized Follow-up Period (IFUP) in which they were monitored for B cell and IgG normalization until individual study termination.
1069349|NCT00640315|B3|Baseline|Total|Total of all reporting groups
1069350|NCT00640315|B2|Baseline|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069351|NCT00640315|B1|Baseline|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069352|NCT00640315|P2|Participant Flow|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069353|NCT00640315|P1|Participant Flow|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069354|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069367|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069368|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069369|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069370|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069371|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069372|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069373|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069374|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069375|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069376|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069377|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069378|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069379|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069380|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069381|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069382|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069383|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069384|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069385|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069386|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069387|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069388|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069389|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069390|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069391|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069392|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069393|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069394|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069395|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069396|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069397|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069398|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069399|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069400|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069401|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069402|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069403|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069404|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069405|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069406|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069407|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069728|NCT00639158|O2|Outcome|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
1069408|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069409|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069410|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069411|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069412|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069413|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069414|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069415|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069416|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069417|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069418|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069419|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069420|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069421|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069422|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069423|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069424|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069425|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069426|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069427|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069428|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069429|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069430|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069431|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069432|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069433|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069434|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069435|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069436|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069437|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069438|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069439|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069440|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069441|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069442|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069443|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069444|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069445|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069446|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069447|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069448|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069729|NCT00639158|O1|Outcome|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
1069449|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069450|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069451|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069452|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069453|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069454|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069455|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069456|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069457|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069458|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069459|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069460|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069461|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069462|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069463|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069464|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069465|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069466|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069467|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069468|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069469|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069470|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069471|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069472|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069473|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069474|NCT00640315|O2|Outcome|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069475|NCT00640315|O1|Outcome|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069476|NCT00640315|E2|Reported Event|Riociguat (Adempas, BAY63-2521) 2.5 mg|Participants received two single oral doses of 2.5 mg riociguat on study day 1 and study day 3.
1069477|NCT00640315|E1|Reported Event|Riociguat (Adempas, BAY63-2521) 1.0 mg|Participants received two single oral doses of 1.0 mg riociguat on study day 1 and study day 3.
1069478|NCT00640042|B1|Baseline|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
1069479|NCT00640042|P1|Participant Flow|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
1069480|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
1069481|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
1069514|NCT00640016|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1074100|NCT00629239|E2|Reported Event|Placebo|Placebo
1069482|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
1069483|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
1069484|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
1069485|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
1069486|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
1069487|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
1069488|NCT00640042|O1|Outcome|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
1069489|NCT00640042|E1|Reported Event|Avinza|Subjects were prescribed Avinza at a QD (once daily) dose determined by the investigator and in adherence to the current Avinza prescribing information. Subjects were titrated on Avinza for up to one month and evaluated approximately 3 months at monthly visits once a stable dose was achieved. Avinza dosing was adjustable according to routine clinical practice, in order to achieve a balance of analgesia and opioid side effects. Avinza dose could not exceed 1600mg/day.
1069490|NCT00640016|B5|Baseline|Total|Total of all reporting groups
1069491|NCT00640016|B4|Baseline|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069492|NCT00640016|B3|Baseline|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069493|NCT00640016|B2|Baseline|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069494|NCT00640016|B1|Baseline|Placebo|Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069495|NCT00640016|P4|Participant Flow|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069496|NCT00640016|P3|Participant Flow|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069497|NCT00640016|P2|Participant Flow|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069498|NCT00640016|P1|Participant Flow|Placebo|Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069499|NCT00640016|O4|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069500|NCT00640016|O3|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069501|NCT00640016|O2|Outcome|CAT-354 1 mg/kg|CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069502|NCT00640016|O1|Outcome|Placebo|Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069503|NCT00640016|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069504|NCT00640016|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069505|NCT00640016|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069506|NCT00640016|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069507|NCT00640016|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069508|NCT00640016|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069509|NCT00640016|O3|Outcome|CAT-354 10 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069510|NCT00640016|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069511|NCT00640016|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069512|NCT00640016|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069515|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069516|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069517|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069518|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069519|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069520|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069521|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069522|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069523|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069524|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069525|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069526|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069527|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069528|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069529|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069530|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069531|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069532|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069533|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069534|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069535|NCT00640016|O2|Outcome|Sub-therapeutic Dose (Placebo or CAT-354 1mg/kg)|Placebo or CAT-354 1 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069536|NCT00640016|O1|Outcome|Therapeutic-dose (CAT-354 5mg/kg and CAT-354 10mg/kg)|CAT-354 5 mg/kg or 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069537|NCT00640016|E4|Reported Event|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069538|NCT00640016|E3|Reported Event|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069539|NCT00640016|E2|Reported Event|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
1069540|NCT00640016|E1|Reported Event|Placebo|Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56
1069541|NCT00639860|B1|Baseline|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.~OSSIX-Plus: resorbable collagen membrane"
1069542|NCT00639860|P1|Participant Flow|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.~OSSIX-Plus: resorbable collagen membrane"
1069543|NCT00639860|O1|Outcome|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.~OSSIX-Plus: resorbable collagen membrane"
1069544|NCT00639860|O1|Outcome|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.~OSSIX-Plus: resorbable collagen membrane"
1069545|NCT00639860|O1|Outcome|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.~OSSIX-Plus: resorbable collagen membrane"
1069546|NCT00639860|O1|Outcome|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.~OSSIX-Plus: resorbable collagen membrane"
1069547|NCT00639860|O1|Outcome|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.~OSSIX-Plus: resorbable collagen membrane"
1069548|NCT00639860|E1|Reported Event|Placing OSSIX-Plus in Extraction Site|"Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.~OSSIX-Plus: resorbable collagen membrane"
1069549|NCT00639769|B1|Baseline|Therapeutic Intervention|Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
1069550|NCT00639769|P1|Participant Flow|Therapeutic Intervention|Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
1069551|NCT00639769|O1|Outcome|Therapeutic Intervention|Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
1069552|NCT00639769|O1|Outcome|Therapeutic Intervention|Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
1069553|NCT00639769|E1|Reported Event|Therapeutic Intervention|Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2
1069554|NCT00639717|B1|Baseline|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:~Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.~GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
1069555|NCT00639717|P1|Participant Flow|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:~Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.~GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
1069556|NCT00639717|O1|Outcome|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:~Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.~GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
1069557|NCT00639717|O1|Outcome|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:~Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.~GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
1069558|NCT00639717|O1|Outcome|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:~Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.~GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
1069559|NCT00639717|O1|Outcome|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:~Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.~GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
1069560|NCT00639717|O1|Outcome|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:~Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.~GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
1069561|NCT00639717|E1|Reported Event|Etanercept and ECP|"Etanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention:~Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant.~GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant."
1069562|NCT00639678|B5|Baseline|Total|Total of all reporting groups
1069563|NCT00639678|B4|Baseline|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069564|NCT00639678|B3|Baseline|Raxibacumab - Single-Dose|Participants received a single dose of 40 mg/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069565|NCT00639678|B2|Baseline|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
1069566|NCT00639678|B1|Baseline|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
1069567|NCT00639678|P4|Participant Flow|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069568|NCT00639678|P3|Participant Flow|Raxibacumab - Single-Dose|Participants received a single dose of 40 mg/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069569|NCT00639678|P2|Participant Flow|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
1069710|NCT00639379|E2|Reported Event|Alphafilcon A Toric / Senofilcon A Toric|alphafilcon A toric work bilaterally during first 2-week period, senofilcon A toric work bilaterally during second 2-week period.
1069570|NCT00639678|P1|Participant Flow|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
1069571|NCT00639678|O1|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069572|NCT00639678|O1|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069573|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069574|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069575|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
1069576|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
1069577|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069578|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069579|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
1069580|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
1069581|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069582|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069583|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
1069584|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
1069585|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069586|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069587|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
1069588|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
1069589|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069590|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069591|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
1069592|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
1069593|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069594|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069595|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
1069711|NCT00639379|E1|Reported Event|Senofilcon A Toric / Alphafilcon A Toric|senofilcon A toric work bilaterally during first 2-week period, alphafilcon A toric work bilaterally during second 2-week period.
1069596|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
1069597|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069598|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069599|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
1069600|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
1069601|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069602|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069603|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
1069604|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
1069605|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069606|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069607|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
1069608|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
1069609|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069610|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069611|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
1069612|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
1069613|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069614|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069615|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
1069616|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
1069617|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069618|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069619|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
1069620|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
1069621|NCT00639678|O4|Outcome|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069658|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
1069622|NCT00639678|O3|Outcome|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069623|NCT00639678|O2|Outcome|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
1069624|NCT00639678|O1|Outcome|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
1069625|NCT00639678|E4|Reported Event|Raxibacumab - Double-Dose|Participants received a double dose of 40 mg/kg raxibacumab administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069626|NCT00639678|E3|Reported Event|Raxibacumab - Single-Dose|Participants received a single dose of 40 milligrams (mg)/kilogram (kg) raxibacumab administered via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of raxibacumab.
1069627|NCT00639678|E2|Reported Event|Placebo - Double-Dose|Participants received a double dose of placebo administered 14 days apart via IV infusion. Participants were treated with oral diphenhydramine (25-50 mg) up to 60 minutes prior to infusion of placebo.
1069628|NCT00639678|E1|Reported Event|Placebo - Single-Dose|Participants received a single dose of placebo administered via intravenous (IV) infusion. Participants were treated with oral diphenhydramine (25-50 milligrams [mg]) up to 60 minutes prior to infusion of placebo.
1069629|NCT00639509|B1|Baseline|IMC-A12|Participants will receive IMC-A12 at a dose of 6mg/kg IV over 1 hour on Day 1 every week.
1069630|NCT00639509|P1|Participant Flow|Treatment (Monoclonal Antibody Therapy)|Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
1069631|NCT00639509|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
1069632|NCT00639509|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
1069633|NCT00639509|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
1069634|NCT00639509|E1|Reported Event|Treatment (Monoclonal Antibody Therapy)|Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
1069635|NCT00639457|B3|Baseline|Total|Total of all reporting groups
1069636|NCT00639457|B2|Baseline|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
1069637|NCT00639457|B1|Baseline|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
1069638|NCT00639457|P2|Participant Flow|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
1069639|NCT00639457|P1|Participant Flow|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
1069640|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
1069641|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
1069642|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
1069643|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
1069644|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
1069645|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
1069646|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
1069647|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
1069648|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
1069649|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
1069650|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
1069651|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
1069652|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
1069653|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
1069654|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
1069655|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
1069656|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
1069657|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
1069712|NCT00639223|B3|Baseline|Total|Total of all reporting groups
1069660|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
1069661|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
1069662|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
1069663|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
1069664|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
1069665|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
1069666|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
1069667|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
1069668|NCT00639457|O2|Outcome|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
1069669|NCT00639457|O1|Outcome|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
1069670|NCT00639457|E2|Reported Event|Pioglitazone + Exercise Training|Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer.
1069671|NCT00639457|E1|Reported Event|Pioglitazone|Pioglitazone (Actos; 30mg/day) for 16 weeks.
1069672|NCT00639418|B5|Baseline|Total|Total of all reporting groups
1069673|NCT00639418|B4|Baseline|Participants 9 to 18 Years|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 9 to 17 years of age
1069674|NCT00639418|B3|Baseline|Participants 5 to 8 Years|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 5 to 8 years of age
1069675|NCT00639418|B2|Baseline|Participants 24 to 59 Months|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 24 to 59 months of age
1069676|NCT00639418|B1|Baseline|Participants 6 to 23 Months|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 6 to 23 months of age
1069677|NCT00639418|P4|Participant Flow|Participants 9 to 18 Years|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 9 to 17 years of age
1069678|NCT00639418|P3|Participant Flow|Participants 5 to 8 Years|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 5 to 8 years of age
1069679|NCT00639418|P2|Participant Flow|Participants 24 to 59 Months|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 24 to 59 months of age
1069680|NCT00639418|P1|Participant Flow|Participants 6 to 23 Months|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 6 to 23 months of age
1069681|NCT00639418|O4|Outcome|Staff Attitudes: Number of Doses|Number of sites that agreed or somewhat agreed that they strongly recommend that previously unvaccinated patients less than 9 years of age receive 2 doses of influenza vaccine
1069682|NCT00639418|O3|Outcome|Staff Attitudes: 5 to 18 Year Old Patients|Number of sites that agreed or somewhat agreed that they strongly recommend that patients 5 to 18 years of age without high-risk medical conditions be vaccinated against influenza each year
1069683|NCT00639418|O2|Outcome|Staff Attitudes: 6 Months to 5 Year Old Patients|Number of sites that strongly recommend that patients 6 months to 5 years of age be vaccinated against influenza each year.
1069684|NCT00639418|O1|Outcome|Staff Attitudes: High-risk Medical Conditions|Number of sites that agreed or somewhat agreed that they strongly recommend seasonal influenza vaccination to patients 5 to 18 years of age with high-risk medical conditions
1069685|NCT00639418|O4|Outcome|Participants 9 to 18 Years|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 9 to 17 years of age
1069686|NCT00639418|O3|Outcome|Participants 5 to 8 Years|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 5 to 8 years of age
1069687|NCT00639418|O2|Outcome|Participants 24 to 59 Months|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 24 to 59 months of age
1069688|NCT00639418|O1|Outcome|Participants 6 to 23 Months|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 6 to 23 months of age
1069689|NCT00639418|O4|Outcome|Participants 9 to 18 Years|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 9 to 17 years of age
1069690|NCT00639418|O3|Outcome|Participants 5 to 8 Years|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 5 to 8 years of age
1069691|NCT00639418|O2|Outcome|Participants 24 to 59 Months|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 24 to 59 months of age
1069692|NCT00639418|O1|Outcome|Participants 6 to 23 Months|Pediatric influenza vaccine coverage within practicing pediatricians’ offices for participants 6 to 23 months of age
1069693|NCT00639418|E4|Reported Event|Children 9 to 18 Years|AEs were not collected in this observational study of physician vaccination practices.
1069694|NCT00639418|E3|Reported Event|Children 5 to 8 Years|AEs were not collected in this observational study of physician vaccination practices.
1069695|NCT00639418|E2|Reported Event|Children 24 to 59 Months|AEs were not collected in this observational study of physician vaccination practices.
1069696|NCT00639418|E1|Reported Event|Children 6 to 23 Months|AEs were not collected in this observational study of physician vaccination practices.
1069697|NCT00639379|B1|Baseline|Total Completed Participants|
1069698|NCT00639379|P2|Participant Flow|Alphafilcon A Toric / Senofilcon A Toric|alphafilcon A toric work bilaterally during first 2-week period, senofilcon A toric work bilaterally during second 2-week period.
1069699|NCT00639379|P1|Participant Flow|Senofilcon A Toric / Alphafilcon A Toric|senofilcon A toric work bilaterally during first 2-week period, alphafilcon A toric work bilaterally during second 2-week period.
1069700|NCT00639379|O2|Outcome|Alphafilcon A Toric|
1069730|NCT00639158|O2|Outcome|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
1069731|NCT00639158|O1|Outcome|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
1069732|NCT00639158|O2|Outcome|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
1069733|NCT00639158|O1|Outcome|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
1069734|NCT00639158|O2|Outcome|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
1069735|NCT00639158|O1|Outcome|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
1069736|NCT00639158|O2|Outcome|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
1069737|NCT00639158|O1|Outcome|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
1069738|NCT00639158|O2|Outcome|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
1069739|NCT00639158|O1|Outcome|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
1069740|NCT00639158|O2|Outcome|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
1069741|NCT00639158|O1|Outcome|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
1069742|NCT00639158|O2|Outcome|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
1069743|NCT00639158|O1|Outcome|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
1069744|NCT00639158|E2|Reported Event|Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe|
1069745|NCT00639158|E1|Reported Event|ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe|
1069746|NCT00639093|B3|Baseline|Total|Total of all reporting groups
1069747|NCT00639093|B2|Baseline|VR - Balls (Control)|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).~During the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer)."
1069748|NCT00639093|B1|Baseline|VR - Cigarettes|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).~During the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer)."
1069749|NCT00639093|P2|Participant Flow|VR - Balls (Control)|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).~During the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer)."
1069750|NCT00639093|P1|Participant Flow|VR - Cigarettes|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).~During the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer)."
1069751|NCT00639093|O2|Outcome|VR - Balls (Control)|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).~During the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer)."
1069752|NCT00639093|O1|Outcome|VR - Cigarettes|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).~During the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer)."
1069753|NCT00639093|E2|Reported Event|VR - Balls (Control)|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).~During the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer)."
1069754|NCT00639093|E1|Reported Event|VR - Cigarettes|"All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR).~During the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer)."
1069755|NCT00639002|B1|Baseline|Ruxolitinib Then Ruxolitinib + Dexamethasone|Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days. For those patients who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or withdrew consent then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 for four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit.
1069756|NCT00639002|P1|Participant Flow|Ruxolitinib Then Ruxolitinib + Dexamethasone|Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days. For those patients who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or withdrew consent then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 for four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit.
1069757|NCT00639002|O1|Outcome|Ruxolitinib Then Ruxolitinib + Dexamethasone|Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days. For those patients who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or withdrew consent then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 for four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit.
1069799|NCT00638989|O2|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
1069800|NCT00638989|O1|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
1069801|NCT00638989|E3|Reported Event|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
1069802|NCT00638989|E2|Reported Event|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
1069758|NCT00639002|O1|Outcome|Ruxolitinib Then Ruxolitinib + Dexamethasone|Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days. For those patients who had disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion or withdrew consent then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 for four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit.
1069759|NCT00639002|E2|Reported Event|Ruxolitinib + Dexamethasone|Following administration of ruxolitinib 25 mg bid alone, for those patients who had disease progression at any time, stable disease for 3 cycles, did not meet a withdrawal criterion, or withdrew consent, then 40 mg of dexamethasone was added to ruxolitinib on Days 1 to 4, 9 to 12, and 17 to 20 of four 28-day cycles. After the 4th cycle, 40 mg of dexamethasone was administered only on Days 1 to 4 of each subsequent cycle. Patients could continue to receive monotherapy or combination therapy indefinitely as long as no withdrawal criterion was met, did not have progressive disease and were receiving some clinical benefit.
1069760|NCT00639002|E1|Reported Event|Ruxolitinib|Patients received ruxolitinib 25 mg orally twice daily (bid) in each treatment cycle of 28 days until the following criteria were met: Disease progression at any time or stable disease for 3 cycles and did not meet a withdrawal criterion, or withdrew consent.
1069761|NCT00638989|B4|Baseline|Total|Total of all reporting groups
1069762|NCT00638989|B3|Baseline|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
1069763|NCT00638989|B2|Baseline|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
1069764|NCT00638989|B1|Baseline|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
1069765|NCT00638989|P3|Participant Flow|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
1069766|NCT00638989|P2|Participant Flow|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
1069767|NCT00638989|P1|Participant Flow|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
1069768|NCT00638989|O1|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
1069769|NCT00638989|O1|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
1069770|NCT00638989|O2|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
1069771|NCT00638989|O1|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
1069772|NCT00638989|O3|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
1069773|NCT00638989|O2|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
1069774|NCT00638989|O1|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
1069775|NCT00638989|O3|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
1069776|NCT00638989|O2|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
1069777|NCT00638989|O1|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
1069778|NCT00638989|O3|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
1069779|NCT00638989|O2|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
1069780|NCT00638989|O1|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
1069781|NCT00638989|O3|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
1069782|NCT00638989|O2|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
1069783|NCT00638989|O1|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
1069784|NCT00638989|O3|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
1069785|NCT00638989|O2|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
1069786|NCT00638989|O1|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
1069787|NCT00638989|O3|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
1069788|NCT00638989|O2|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
1069789|NCT00638989|O1|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
1069790|NCT00638989|O3|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
1069791|NCT00638989|O2|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
1069792|NCT00638989|O1|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
1069793|NCT00638989|O3|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
1069794|NCT00638989|O2|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
1069795|NCT00638989|O1|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
1069796|NCT00638989|O3|Outcome|CAT-354 300 mg (Subcutaneous)|A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
1069797|NCT00638989|O2|Outcome|CAT-354 150 mg (Subcutaneous)|A single dose of CAT-354 150 mg injection, subcutaneously on Day 0.
1069798|NCT00638989|O1|Outcome|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
1074101|NCT00629239|E1|Reported Event|AZD4818|AZD4818 Turbuhaler
1069803|NCT00638989|E1|Reported Event|CAT-354 150 mg (Intravenous)|A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
1069804|NCT00638963|B3|Baseline|Total|Total of all reporting groups
1069805|NCT00638963|B2|Baseline|Observational|No temozolomide treatment
1069806|NCT00638963|B1|Baseline|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
1069807|NCT00638963|P2|Participant Flow|Observational|No temozolomide treatment
1069808|NCT00638963|P1|Participant Flow|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
1069809|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
1069810|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
1069811|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
1069812|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
1069813|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
1069814|NCT00638963|O2|Outcome|Observational|No temozolomide treatment
1069815|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
1069816|NCT00638963|O2|Outcome|Observational|No temozolomide treatment
1069817|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
1069818|NCT00638963|O2|Outcome|Observational|No temozolomide treatment
1069819|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
1069820|NCT00638963|O2|Outcome|Observational|No temozolomide treatment
1069821|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
1069822|NCT00638963|O2|Outcome|Observational|No temozolomide treatment
1069823|NCT00638963|O1|Outcome|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
1069824|NCT00638963|E2|Reported Event|Observational|No temozolomide treatment
1069825|NCT00638963|E1|Reported Event|Temozolomide|Capsules to equal 75 mg/m^2, orally, daily for 6 weeks, in 3 eight-week cycles
1069826|NCT00638937|B1|Baseline|Treatment (Saracatinib)|"Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: Given PO~laboratory biomarker analysis: Correlative studies"
1069827|NCT00638937|P1|Participant Flow|Treatment (Saracatinib)|"Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: 175mg given PO daily~laboratory biomarker analysis: Correlative studies"
1069828|NCT00638937|O1|Outcome|Treatment (Saracatinib)|"Patients receive saracatinib PO, at a dose of 175 mg QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: Given PO"
1069829|NCT00638937|O1|Outcome|Treatment (Saracatinib)|"Patients receive saracatinib PO, at a dose of 175 mg QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: Given PO"
1069830|NCT00638937|O1|Outcome|Treatment (Saracatinib)|"Patients receive saracatinib PO, at a dose of 175 mg QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: Given PO"
1069831|NCT00638937|O1|Outcome|Treatment (Saracatinib)|"Patients receive saracatinib PO, at a dose of 175 mg QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: Given PO"
1069832|NCT00638937|O1|Outcome|Treatment (Saracatinib)|"Patients receive saracatinib PO, at a dose of 175 mg QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: Given PO"
1069833|NCT00638937|O1|Outcome|Treatment (Saracatinib)|"Patients receive saracatinib PO, at a dose of 175 mg QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: Given PO"
1069834|NCT00638937|O1|Outcome|Treatment (Saracatinib)|"Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: Given PO~laboratory biomarker analysis: Correlative studies"
1069835|NCT00638937|E1|Reported Event|Treatment (Saracatinib)|"Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression~saracatinib: Given PO~laboratory biomarker analysis: Correlative studies"
1069836|NCT00638924|B1|Baseline|Inactive Woman|40 women, 20 to 30 years old, healthy and sedentary
1069837|NCT00638924|P1|Participant Flow|Inactive Woman|40 women, 20 to 30 years old, healthy and sedentary
1069838|NCT00638924|O1|Outcome|Inactive Woman|40 women, 20 to 30 years old, healthy and sedentary
1069839|NCT00638924|O1|Outcome|Inactive Woman|40 women, 20 to 30 years old, healthy and sedentary
1069840|NCT00638924|E1|Reported Event|Inactive Woman|40 women, 20 to 30 years old, healthy and sedentary
1069841|NCT00638885|B1|Baseline|Group 1|Vietnam veterans who were twins with and without posttraumatic stress disorder underwent neuropsychological testing and MRI imaging of hippocampal volume at baseline. There were no clinical interventions.
1069842|NCT00638885|P1|Participant Flow|Group 1|Vietnam veterans who were twins with and without posttraumatic stress disorder underwent neuropsychological testing and MRI imaging of hippocampal volume at baseline. There were no clinical interventions.
1069843|NCT00638885|O1|Outcome|Vietnam Veteran Twins|Vietnam veteran twins with and without PTSD.
1069844|NCT00638885|E1|Reported Event|Vietnam Twins With and Without PTSD|
1069845|NCT00638846|B3|Baseline|Total|Total of all reporting groups
1069846|NCT00638846|B2|Baseline|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
1069847|NCT00638846|B1|Baseline|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
1069848|NCT00638846|P2|Participant Flow|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
1069849|NCT00638846|P1|Participant Flow|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
1069850|NCT00638846|O2|Outcome|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
1069851|NCT00638846|O1|Outcome|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
1069852|NCT00638846|O2|Outcome|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
1069853|NCT00638846|O1|Outcome|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
1069854|NCT00638846|O2|Outcome|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
1069855|NCT00638846|O1|Outcome|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
1069856|NCT00638846|O2|Outcome|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
1069857|NCT00638846|O1|Outcome|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
1069858|NCT00638846|O2|Outcome|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
1069859|NCT00638846|O1|Outcome|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
1069860|NCT00638846|O2|Outcome|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
1069861|NCT00638846|O1|Outcome|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
1069862|NCT00638846|E2|Reported Event|Balafilcon A Toric|balafilcon A toric contact lens. Analysis includes participants that completed the study.
1069863|NCT00638846|E1|Reported Event|Senofilcon A Toric|senofilcon A toric contact lens. Analysis includes participants that completed the study.
1069864|NCT00638820|B1|Baseline|Patients With Osteopetrosis Who Received Transplant|All patients enrolled with osteopetrosis and received transplant.
1069865|NCT00638820|P1|Participant Flow|Patients With Osteopetrosis Who Received Transplant|All patients enrolled with osteopetrosis and received transplant.
1069866|NCT00638820|O1|Outcome|Patients With Osteopetrosis Who Received Transplant|All patients enrolled with osteopetrosis and received transplant.
1069867|NCT00638820|O1|Outcome|Patients With Osteopetrosis Who Received Transplant|All patients enrolled with osteopetrosis and received transplant.
1069868|NCT00638820|O1|Outcome|Patients With Osteopetrosis Who Received Transplant|All patients enrolled with osteopetrosis and received transplant.
1069869|NCT00638820|O1|Outcome|Patients With Osteopetrosis Who Received Transplant|All patients enrolled with osteopetrosis and received transplant.
1069870|NCT00638820|E1|Reported Event|Patients With Osteopetrosis Who Received Transplant|All patients enrolled with osteopetrosis and received transplant.
1069871|NCT00638716|B4|Baseline|Total|Total of all reporting groups
1069872|NCT00638716|B3|Baseline|Placebo|"12 weekly doses of placebo~Placebo: Placebo"
1069873|NCT00638716|B2|Baseline|1.5 or 2.0 mg CJC-1134-PC|"4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC~CJC-1134-PC: 1.5 or 2.0 mg CJC-1134-PC"
1069874|NCT00638716|B1|Baseline|1.5 mg CJC-1134-PC|"12 weekly doses of 1.5 mg CJC-1134-PC~CJC-1134-PC: 1.5 mg CJC-1134-PC"
1069875|NCT00638716|P3|Participant Flow|Placebo|"12 weekly doses of placebo~Placebo: Placebo"
1069876|NCT00638716|P2|Participant Flow|1.5 or 2.0 mg CJC-1134-PC|"4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC~CJC-1134-PC: 1.5 or 2.0 mg CJC-1134-PC"
1069877|NCT00638716|P1|Participant Flow|1.5 mg CJC-1134-PC|"12 weekly doses of 1.5 mg CJC-1134-PC~CJC-1134-PC: 1.5 mg CJC-1134-PC"
1069878|NCT00638716|O3|Outcome|Placebo|"12 weekly doses of placebo~Placebo: Placebo"
1069879|NCT00638716|O2|Outcome|1.5 or 2.0 mg CJC-1134-PC|"4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC~CJC-1134-PC: 1.5 or 2.0 mg CJC-1134-PC"
1069880|NCT00638716|O1|Outcome|1.5 mg CJC-1134-PC|"12 weekly doses of 1.5 mg CJC-1134-PC~CJC-1134-PC: 1.5 mg CJC-1134-PC"
1069881|NCT00638716|O3|Outcome|Placebo|"12 weekly doses of placebo~Placebo: Placebo"
1069882|NCT00638716|O2|Outcome|1.5 or 2.0 mg CJC-1134-PC|"4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC~CJC-1134-PC: 1.5 or 2.0 mg CJC-1134-PC"
1069883|NCT00638716|O1|Outcome|1.5 mg CJC-1134-PC|"12 weekly doses of 1.5 mg CJC-1134-PC~CJC-1134-PC: 1.5 mg CJC-1134-PC"
1069884|NCT00638716|O3|Outcome|Placebo|"12 weekly doses of placebo~Placebo: Placebo"
1069885|NCT00638716|O2|Outcome|1.5 or 2.0 mg CJC-1134-PC|"4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC~CJC-1134-PC: 1.5 or 2.0 mg CJC-1134-PC"
1069886|NCT00638716|O1|Outcome|1.5 mg CJC-1134-PC|"12 weekly doses of 1.5 mg CJC-1134-PC~CJC-1134-PC: 1.5 mg CJC-1134-PC"
1069887|NCT00638716|E3|Reported Event|Placebo|"12 weekly doses of placebo~Placebo: Placebo"
1069888|NCT00638716|E2|Reported Event|1.5 or 2.0 mg CJC-1134-PC|"4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC~CJC-1134-PC: 1.5 or 2.0 mg CJC-1134-PC"
1069889|NCT00638716|E1|Reported Event|1.5 mg CJC-1134-PC|"12 weekly doses of 1.5 mg CJC-1134-PC~CJC-1134-PC: 1.5 mg CJC-1134-PC"
1069890|NCT00638690|B3|Baseline|Total|Total of all reporting groups
1069891|NCT00638690|B2|Baseline|Placebo|Placebo plus prednisone/prednisolone
1069892|NCT00638690|B1|Baseline|Abiraterone Acetate|Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
1069893|NCT00638690|P2|Participant Flow|Placebo|Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
1069894|NCT00638690|P1|Participant Flow|Abiraterone Acetate|Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
1069895|NCT00638690|O2|Outcome|Placebo|Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
1069896|NCT00638690|O1|Outcome|Abiraterone Acetate|Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
1074102|NCT00629018|B3|Baseline|Total|Total of all reporting groups
1069897|NCT00638690|O2|Outcome|Placebo|Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
1069898|NCT00638690|O1|Outcome|Abiraterone Acetate|Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
1069899|NCT00638690|O2|Outcome|Placebo|Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
1069900|NCT00638690|O1|Outcome|Abiraterone Acetate|Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
1069901|NCT00638690|O2|Outcome|Placebo|Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
1069902|NCT00638690|O1|Outcome|Abiraterone Acetate|Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
1069903|NCT00638690|E3|Reported Event|Placebo to Abiraterone Acetate|Placebo plus prednisone/prednisolone crossed over to abiraterone acetate plus prednisone/prednisolone
1069904|NCT00638690|E2|Reported Event|Placebo|Placebo plus prednisone/prednisolone
1069905|NCT00638690|E1|Reported Event|Abiraterone Acetate|Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
1069906|NCT00638651|B1|Baseline|Laser Treatment With Imiquimod Cream or Placebo|One participant with two tattoos were selected. Each tattoo were treated with either laser and imiquimod 5% cream or laser and placebo cream.
1069907|NCT00638651|P1|Participant Flow|Laser Treatment With Imiquimod Cream or Placebo|One participant with two tattoos were selected. Each tattoo were treated with either laser and imiquimod 5% cream or laser and placebo cream.
1069908|NCT00638651|O2|Outcome|Laser Treatment With Placebo Cream (Group 2)|"The tattoo will be treated with laser and placebo topical cream~1064 nm Nd:YAG laser: The laser used will be a 1064 nm Nd:YAG, with a 10ns pulse, 3mm spot size and 4 joules of energy"
1069909|NCT00638651|O1|Outcome|Laser Treatment With Imiquimod (Group 1)|"The tattoo will be treated with laser and imiquimod 5% cream~1064 nm Nd:YAG laser: The laser used will be a 1064 nm Nd:YAG, with a 10ns pulse, 3mm spot size and 4 joules of energy~Imiquimod, 5% cream: 2 weeks after the laser procedure the imiquimod will be applied 3 times a week for one month"
1069910|NCT00638651|E1|Reported Event|Laser Treatment With Imiquimod Cream or Placebo|One participant with two tattoos were selected. Each tattoo were treated with either laser and imiquimod 5% cream or laser and placebo cream.
1069911|NCT00638443|B1|Baseline|All Study Participants|"Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days~Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days"
1069912|NCT00638443|P2|Participant Flow|Diphenhydramine First, Pregabalin Second|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days; washout 7 days; Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days.
1069913|NCT00638443|P1|Participant Flow|Pregabalin First, Diphenhydramine Second|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days; washout 7 days; Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
1069914|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
1069915|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
1069916|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
1069917|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
1069918|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
1069919|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
1069920|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
1069921|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
1069922|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
1069923|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
1069924|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
1069925|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
1069926|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
1069927|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
1069928|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
1069929|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
1069930|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
1069931|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
1069932|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
1069933|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
1069934|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
1069935|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
1069936|NCT00638443|O2|Outcome|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days.
1069937|NCT00638443|O1|Outcome|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days.
1069938|NCT00638443|E2|Reported Event|Diphenhydramine|Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days.
1069939|NCT00638443|E1|Reported Event|Pregabalin|Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days.
1069940|NCT00638378|B1|Baseline|Ruxolitinib|Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
1069941|NCT00638378|P1|Participant Flow|Ruxolitinib|Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
1069942|NCT00638378|O1|Outcome|Ruxolitinib|Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
1069943|NCT00638378|O1|Outcome|Ruxolitinib|Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
1069944|NCT00638378|O1|Outcome|Ruxolitinib|Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
1069945|NCT00638378|O1|Outcome|Ruxolitinib|Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
1069946|NCT00638378|E1|Reported Event|Ruxolitinib|Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
1069947|NCT00638365|B4|Baseline|Total|Total of all reporting groups
1069948|NCT00638365|B3|Baseline|KB001, 10 mg/kg|
1069949|NCT00638365|B2|Baseline|KB001, 3 mg/kg|
1069950|NCT00638365|B1|Baseline|Placebo|
1069951|NCT00638365|P3|Participant Flow|KB001, 10 mg/kg|
1069952|NCT00638365|P2|Participant Flow|KB001, 3 mg/kg|
1069953|NCT00638365|P1|Participant Flow|Placebo|
1069954|NCT00638365|O3|Outcome|KB001, 10 mg/kg|
1069955|NCT00638365|O2|Outcome|KB001, 3 mg/kg|
1069956|NCT00638365|O1|Outcome|Placebo|
1069957|NCT00638365|E3|Reported Event|KB001, 10 mg/kg|
1069958|NCT00638365|E2|Reported Event|KB001, 3 mg/kg|
1069959|NCT00638365|E1|Reported Event|Placebo|
1069960|NCT00638235|B10|Baseline|Total|Total of all reporting groups
1069961|NCT00638235|B9|Baseline|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1069962|NCT00638235|B8|Baseline|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
1069963|NCT00638235|B7|Baseline|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1069964|NCT00638235|B6|Baseline|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1069965|NCT00638235|B5|Baseline|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1069966|NCT00638235|B4|Baseline|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1069967|NCT00638235|B3|Baseline|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse
1069968|NCT00638235|B2|Baseline|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1074160|NCT00628862|B2|Baseline|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
1069969|NCT00638235|B1|Baseline|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1069970|NCT00638235|P9|Participant Flow|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1069971|NCT00638235|P8|Participant Flow|Phase VI (Elevate Anterior Gen 1, for Study Use Only, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
1069972|NCT00638235|P7|Participant Flow|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1069973|NCT00638235|P6|Participant Flow|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1069974|NCT00638235|P5|Participant Flow|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1069975|NCT00638235|P4|Participant Flow|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1069976|NCT00638235|P3|Participant Flow|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
1069977|NCT00638235|P2|Participant Flow|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1069978|NCT00638235|P1|Participant Flow|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1069979|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1069980|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
1069981|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1069982|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1069983|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1069984|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1069985|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
1069986|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1069987|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1069988|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1069989|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
1069990|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1069991|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1069992|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1069993|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1069994|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
1069995|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1069996|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1069997|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1069998|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
1069999|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070000|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070001|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070002|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070003|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
1070004|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070005|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070006|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070007|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
1070008|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070009|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070010|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070011|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070012|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
1070013|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070014|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070015|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070016|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
1070017|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070018|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070019|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070020|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070021|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
1070022|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070023|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070024|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070025|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
1070026|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070027|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070028|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070029|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070030|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
1070031|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070032|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070033|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070034|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, Fot PROPEL Study Use Only)
1070035|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070036|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070037|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070038|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070039|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
1070040|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070041|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070042|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070043|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
1070044|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070045|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070046|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070047|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070048|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
1070049|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070050|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070051|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070052|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
1070053|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070054|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070055|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070056|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070057|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
1070058|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070059|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070060|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070061|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
1070062|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070063|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070064|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070065|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070066|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
1070067|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070068|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070069|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070070|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
1070071|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070072|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070073|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070074|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070075|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IVmodels"
1070076|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070077|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070078|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070079|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
1070080|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070081|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070082|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070083|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070084|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
1070085|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070086|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070087|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070088|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
1070089|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070090|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070091|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070092|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070093|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
1070094|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070095|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070096|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070225|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070097|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
1070098|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070099|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070100|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070101|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070102|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
1070103|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070104|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070105|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070106|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
1070107|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070108|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070109|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070110|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070111|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
1070112|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070113|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070114|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070115|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
1070116|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070117|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070118|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070119|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070120|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
1070121|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070122|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070123|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070124|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
1070125|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070126|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070127|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070223|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
1070128|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070129|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
1070130|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070131|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070132|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070133|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
1070134|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070135|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070136|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070137|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070138|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
1070139|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070140|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070141|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070142|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
1070143|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070144|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070145|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070146|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070147|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
1070148|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070149|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070150|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070151|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
1070152|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070153|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070154|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070155|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070156|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
1070157|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070158|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070159|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070224|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070160|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
1070161|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070162|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070163|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070164|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070165|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
1070166|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070167|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070168|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070169|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
1070170|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070171|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070172|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070173|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070174|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
1070175|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070176|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070177|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070178|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
1070179|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070180|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070181|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070182|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070183|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
1070184|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070185|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070186|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070187|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
1070188|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070189|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070190|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070682|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
1070191|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070192|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
1070193|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070194|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070195|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070196|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
1070197|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070198|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070199|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070200|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070201|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
1070202|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070203|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070204|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070205|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
1070206|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070207|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070208|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070209|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070210|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
1070211|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070212|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070213|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070214|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
1070215|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070216|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070217|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070218|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070219|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
1070220|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070221|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070222|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1074161|NCT00628862|B1|Baseline|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
1070226|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070227|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070228|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
1070229|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070230|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070231|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070232|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
1070233|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070234|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070235|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070236|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070237|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
1070238|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070239|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070240|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070241|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
1070242|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070243|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070244|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070245|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070246|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
1070247|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070248|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070249|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070250|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
1070251|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070252|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070253|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070254|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070255|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
1070256|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070257|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070258|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070259|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
1070260|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070261|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070262|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070263|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070264|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
1070265|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070266|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070267|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070268|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
1070269|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070270|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070271|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070272|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070273|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
1070274|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070275|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070276|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070277|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
1070278|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070279|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070280|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070281|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070282|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
1070283|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070284|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070285|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070286|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
1070287|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US & Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070288|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070932|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
1070289|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070290|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070291|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
1070292|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070293|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070294|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070295|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
1070296|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070297|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070298|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070299|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070300|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
1070301|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070302|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070303|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070304|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
1070305|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070306|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070307|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070308|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070309|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects had their 24M visit because next generation of Perigee was already under trial in Phase III/IV"
1070310|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070311|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070312|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070313|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
1070314|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070315|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070316|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070317|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070318|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
1070319|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070320|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070321|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070322|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
1070323|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070324|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070325|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070326|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070327|NCT00638235|O3|Outcome|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
1070328|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070329|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070330|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070331|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
1070332|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070333|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070334|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070335|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070336|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
1070337|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070338|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070339|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070340|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
1070341|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070342|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070343|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070344|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070345|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
1070346|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070347|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070348|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070349|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
1070350|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070351|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070529|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
1070352|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070353|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070354|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
1070355|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070356|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070357|NCT00638235|O9|Outcome|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070358|NCT00638235|O8|Outcome|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
1070359|NCT00638235|O7|Outcome|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070360|NCT00638235|O6|Outcome|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070361|NCT00638235|O5|Outcome|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070362|NCT00638235|O4|Outcome|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070363|NCT00638235|O3|Outcome|Phase II (France Only)|AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
1070364|NCT00638235|O2|Outcome|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070365|NCT00638235|O1|Outcome|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070366|NCT00638235|E9|Reported Event|Phase VII (Elevate Anterior Gen 2, US & EU)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2)
1070367|NCT00638235|E8|Reported Event|Phase VI (Elevate Anterior Gen 1, EU Only)|AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
1070368|NCT00638235|E7|Reported Event|Phase V (Elevate Posterior InteXen LP, US Only)|AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse
1070369|NCT00638235|E6|Reported Event|Phase V (Elevate Posterior IntePro Lite, US & EU)|AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse
1070370|NCT00638235|E5|Reported Event|Phase III/IV (Apogee IntePro Lite, US Only)|AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070371|NCT00638235|E4|Reported Event|Phase III/IV (Perigee IntePro Lite, US Only)|AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
1070372|NCT00638235|E3|Reported Event|Phase II (France Only)|"AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.~Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV"
1070373|NCT00638235|E2|Reported Event|Phase I (Intexen LP, US Only)|AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
1070374|NCT00638235|E1|Reported Event|Phase I (IntePro, US Only)|AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
1070375|NCT00638222|B4|Baseline|Total|Total of all reporting groups
1070376|NCT00638222|B3|Baseline|All Study Participants|All enrolled participants were randomized to receive Carvedilol or Placebo in a 2-way crossover design. Each intervention was administered over 8 weeks before switching to the alternative intervention. The study was terminated early, and data were not unblinded so participants cannot be reported separately
1070377|NCT00638222|B2|Baseline|Placebo Then Study Drug|"Subjects will receive placebo for 8 weeks then be given study drug for 8 more.~Placebo: Subjects will receive placebo for 8 weeks then be given study drug for 8 more."
1070378|NCT00638222|B1|Baseline|Carvedilol Then Placebo|"Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.~Carvedilol: Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following."
1070379|NCT00638222|P3|Participant Flow|All Participants|All enrolled participants were randomized to receive Carvedilol or Placebo in a 2-way crossover design. Each intervention was administered over 8 weeks before switching to the alternative intervention. The study was terminated early, and data were not unblinded so participants cannot be reported separately
1070380|NCT00638222|P2|Participant Flow|Placebo Then Study Drug|"Subjects will receive placebo for 8 weeks then be given study drug for 8 more.~Placebo: Subjects will receive placebo for 8 weeks then be given study drug for 8 more."
1070381|NCT00638222|P1|Participant Flow|Carvedilol Then Placebo|"Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.~Carvedilol: Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following."
1070382|NCT00638222|O2|Outcome|Placebo Then Study Drug|"Subjects will receive placebo for 8 weeks then be given study drug for 8 more.~Placebo: Subjects will receive placebo for 8 weeks then be given study drug for 8 more."
1070383|NCT00638222|O1|Outcome|Carvedilol Then Placebo|"Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.~Carvedilol: Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following."
1070384|NCT00638222|E3|Reported Event|All Study Participants|All enrolled participants were randomized to receive Carvedilol or Placebo in a 2-way crossover design. Each intervention was administered over 8 weeks before switching to the alternative intervention. The study was terminated early, and data were not unblinded so participants cannot be reported separately
1070385|NCT00638222|E2|Reported Event|Placebo Then Study Drug|"Subjects will receive placebo for 8 weeks then be given study drug for 8 more.~Placebo: Subjects will receive placebo for 8 weeks then be given study drug for 8 more."
1070386|NCT00638222|E1|Reported Event|Carvedilol Then Placebo|"Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.~Carvedilol: Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following."
1070387|NCT00638183|B1|Baseline|Spiriva Treatment|Daily Therapy
1070388|NCT00638183|P1|Participant Flow|Spiriva Treatment|Daily Therapy
1070389|NCT00638183|O1|Outcome|Spiriva Treatment|Daily Therapy
1070390|NCT00638183|O1|Outcome|Spiriva Treatment|Daily Therapy
1070391|NCT00638183|O1|Outcome|Spiriva Treatment|Daily Therapy
1070392|NCT00638183|O1|Outcome|Spiriva Treatment|Daily Therapy
1070393|NCT00638183|E1|Reported Event|Spiriva Treatment|Daily Therapy
1070394|NCT00638157|B3|Baseline|Total|Total of all reporting groups
1070395|NCT00638157|B2|Baseline|Daptomycin Plus Gentamicin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.
1070396|NCT00638157|B1|Baseline|Daptomycin|"Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a dummy infusion of 0.9% normal saline every 8 hours for the first 3 days of daptomycin therapy."
1070397|NCT00638157|P2|Participant Flow|Daptomycin Plus Gentamicin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.
1070398|NCT00638157|P1|Participant Flow|Daptomycin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a
1070399|NCT00638157|O2|Outcome|Daptomycin Plus Gentamicin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.
1070400|NCT00638157|O1|Outcome|Daptomycin|"Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a dummy infusion of 0.9% normal saline every 8 hours for the first 3 days of daptomycin therapy."
1070401|NCT00638157|O2|Outcome|Daptomycin Plus Gentamicin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.
1070402|NCT00638157|O1|Outcome|Daptomycin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a
1070403|NCT00638157|E2|Reported Event|Daptomycin Plus Gentamicin|Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus intravenous gentamicin 1mg/kg every 8 hours for the first 3 days of daptomycin therapy.
1070404|NCT00638157|E1|Reported Event|Daptomycin|"Intravenous daptomycin 6mg/kg every 24 hours for a recommended minimum duration of 28 days plus a dummy infusion of 0.9% normal saline every 8 hours for the first 3 days of daptomycin therapy."
1070405|NCT00638027|B3|Baseline|Total|Total of all reporting groups
1070406|NCT00638027|B2|Baseline|Placebo|Placebo arm
1070407|NCT00638027|B1|Baseline|Memantine|Memantine 10 mg bid
1070408|NCT00638027|P2|Participant Flow|Placebo|Placebo arm
1070409|NCT00638027|P1|Participant Flow|Memantine|Memantine 10 mg bid
1070410|NCT00638027|O2|Outcome|Placebo|Placebo arm
1070411|NCT00638027|O1|Outcome|Memantine|Memantine 10 mg bid
1070412|NCT00638027|O2|Outcome|Placebo|Placebo arm
1070413|NCT00638027|O1|Outcome|Memantine|Memantine 10 mg bid
1070414|NCT00638027|O2|Outcome|Placebo|Placebo arm
1070415|NCT00638027|O1|Outcome|Memantine|Memantine 10 mg bid
1070416|NCT00638027|E2|Reported Event|Placebo|Placebo arm
1070417|NCT00638027|E1|Reported Event|Memantine|Memantine 10 mg bid
1070418|NCT00638014|B3|Baseline|Total|Total of all reporting groups
1070419|NCT00638014|B2|Baseline|Talon|Subjects randomized to the Talon group received Talons in the sternum plus supplementary wires in the manubrium. The number of Talons inserted was based on patient factors/clinician judgment. For study subjects randomized to the Talon, the device was to be inserted/used in an identical manner to use of the Talon in non-study patients.
1070420|NCT00638014|B1|Baseline|Conventional Wires Only|The control group received conventional wires including double wires to close the sternum.
1070421|NCT00638014|P2|Participant Flow|Talon|Subjects randomized to the Talon group received Talons in the sternum plus supplementary wires in the manubrium. The number of Talons inserted was based on patient factors/clinician judgment. For study subjects randomized to the Talon, the device was to be inserted/used in an identical manner to use of the Talon in non-study patients.
1070422|NCT00638014|P1|Participant Flow|Conventional Wires Only|The control group received conventional wires including double wires to close the sternum.
1070423|NCT00638014|O2|Outcome|Talon|Subjects randomized to the Talon group received Talons in the sternum plus supplementary wires in the manubrium. The number of Talons inserted was based on patient factors/clinician judgment. For study subjects randomized to the Talon, the device was to be inserted/used in an identical manner to use of the Talon in non-study patients.
1070424|NCT00638014|O1|Outcome|Conventional Wires Only|The control group received conventional wires including double wires to close the sternum.
1070425|NCT00638014|O2|Outcome|Talon|Subjects randomized to the Talon group received Talons in the sternum plus supplementary wires in the manubrium. The number of Talons inserted was based on patient factors/clinician judgment. For study subjects randomized to the Talon, the device was to be inserted/used in an identical manner to use of the Talon in non-study patients.
1070426|NCT00638014|O1|Outcome|Conventional Wires Only|The control group received conventional wires including double wires to close the sternum.
1070427|NCT00638014|E2|Reported Event|Talon|Subjects randomized to the Talon group received Talons in the sternum plus supplementary wires in the manubrium. The number of Talons inserted was based on patient factors/clinician judgment. For study subjects randomized to the Talon, the device was to be inserted/used in an identical manner to use of the Talon in non-study patients.
1070428|NCT00638014|E1|Reported Event|Conventional Wires Only|The control group received conventional wires including double wires to close the sternum.
1070429|NCT00637923|B3|Baseline|Total|Total of all reporting groups
1070430|NCT00637923|B2|Baseline|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
1070431|NCT00637923|B1|Baseline|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
1070432|NCT00637923|P2|Participant Flow|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
1070433|NCT00637923|P1|Participant Flow|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
1070434|NCT00637923|O2|Outcome|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
1070435|NCT00637923|O1|Outcome|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
1070436|NCT00637923|O2|Outcome|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
1070437|NCT00637923|O1|Outcome|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
1070438|NCT00637923|O2|Outcome|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
1070439|NCT00637923|O1|Outcome|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
1070440|NCT00637923|O2|Outcome|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
1070441|NCT00637923|O1|Outcome|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
1070442|NCT00637923|O2|Outcome|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
1070443|NCT00637923|O1|Outcome|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
1070444|NCT00637923|O2|Outcome|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
1070445|NCT00637923|O1|Outcome|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
1070446|NCT00637923|O2|Outcome|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
1070447|NCT00637923|O1|Outcome|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
1070448|NCT00637923|O2|Outcome|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
1070449|NCT00637923|O1|Outcome|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
1070450|NCT00637923|E2|Reported Event|Placebo+PR|One placebo tablet orally with food twice daily (b.i.d.) for 4 weeks followed by placebo b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
1070451|NCT00637923|E1|Reported Event|NTZ+PR|One nitazoxanide 500 mg tablet orally with food twice daily (b.i.d.) for 4 weeks followed by 500 mg nitazoxanide b.i.d. plus one weekly injection of 180µg of peginterferon α-2a plus weight-based ribavirin for 48 weeks.
1070452|NCT00637806|B4|Baseline|Total|Total of all reporting groups
1070453|NCT00637806|B3|Baseline|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
1070454|NCT00637806|B2|Baseline|DB MA-CS 300 mg/Day|MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
1070455|NCT00637806|B1|Baseline|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
1070456|NCT00637806|P4|Participant Flow|OL MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 4-week open-label (OL) extension phase
1070457|NCT00637806|P3|Participant Flow|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
1070458|NCT00637806|P2|Participant Flow|DB MA-CS 300 mg/Day|MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
1070459|NCT00637806|P1|Participant Flow|DB MA-CS 550 mg/Day|Megestrol acetate concentrated suspension (MA-CS; 110 mg/mL) administered orally once every 24 hours (q24h), for a daily dose of 550 mg per day (5 mL dose) in the 8-week double-blind (DB) phase
1070460|NCT00637806|O3|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
1070461|NCT00637806|O2|Outcome|DB MA-CS 300 mg/Day|MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
1070462|NCT00637806|O1|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
1070463|NCT00637806|O3|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
1070464|NCT00637806|O2|Outcome|DB MA-CS 300 mg/Day|MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
1070465|NCT00637806|O1|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
1070466|NCT00637806|O3|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
1070467|NCT00637806|O2|Outcome|DB MA-CS 300 mg/Day|MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
1070468|NCT00637806|O1|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
1070469|NCT00637806|O3|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
1070470|NCT00637806|O2|Outcome|DB MA-CS 300 mg/Day|MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
1070471|NCT00637806|O1|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
1070472|NCT00637806|E4|Reported Event|OL MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 4-week OL extension phase
1070473|NCT00637806|E3|Reported Event|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
1070474|NCT00637806|E2|Reported Event|DB MA-CS 300 mg/Day|MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
1070475|NCT00637806|E1|Reported Event|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
1070476|NCT00637780|B1|Baseline|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
1070477|NCT00637780|P1|Participant Flow|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
1070478|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
1070479|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
1070480|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
1070481|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
1070482|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
1070483|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
1070484|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
1070485|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
1070486|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
1070487|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
1070530|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
1070488|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
1070489|NCT00637780|O1|Outcome|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
1070490|NCT00637780|E1|Reported Event|Sulfasalazine in Juvenile Idiopathic Arthritis|All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.
1070491|NCT00637728|B3|Baseline|Total|Total of all reporting groups
1070492|NCT00637728|B2|Baseline|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
1070493|NCT00637728|B1|Baseline|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
1070494|NCT00637728|P3|Participant Flow|OL MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 4-week open-label (OL) extension phase
1070495|NCT00637728|P2|Participant Flow|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
1070496|NCT00637728|P1|Participant Flow|DB MA-CS 550 mg/Day|Megestrol acetate concentrated suspension (MA-CS; 110 mg/mL) administered orally once every 24 hours (q24h), for a daily dose of 550 mg per day (5 mL dose) in the 8-week double-blind (DB) phase
1070497|NCT00637728|O2|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
1070498|NCT00637728|O1|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
1070499|NCT00637728|O2|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
1070500|NCT00637728|O1|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
1070501|NCT00637728|O2|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
1070502|NCT00637728|O1|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
1070503|NCT00637728|O2|Outcome|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
1070504|NCT00637728|O1|Outcome|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
1070505|NCT00637728|E3|Reported Event|OL MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 4-week OL extension phase
1070506|NCT00637728|E2|Reported Event|DB Placebo|Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
1070507|NCT00637728|E1|Reported Event|DB MA-CS 550 mg/Day|MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase
1070508|NCT00637572|B3|Baseline|Total|Total of all reporting groups
1070509|NCT00637572|B2|Baseline|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per as single-dose for 12 weeks
1070510|NCT00637572|B1|Baseline|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per as single-dose for 12 weeks
1070511|NCT00637572|P2|Participant Flow|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
1070512|NCT00637572|P1|Participant Flow|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
1070513|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
1070514|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
1070515|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
1070516|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
1070517|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
1070518|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
1070519|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
1070520|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
1070521|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
1070522|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
1070523|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
1070524|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
1070525|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
1070526|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
1070527|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
1070528|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
1070531|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
1070532|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
1070533|NCT00637572|O2|Outcome|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single-dose for 12 weeks
1070534|NCT00637572|O1|Outcome|Megestrol Acetate Oral Suspension Nanocrystal Dispersion|Subjects were treated with 575 mg per day as single-dose for 12 weeks
1070535|NCT00637572|E2|Reported Event|Megestrol Acetate Oral Suspension Micronized Formulation|Subjects were treated with 800 mg per day as single dose for 12 weeks
1070536|NCT00637572|E1|Reported Event|Megestrol Acetate Oral Suspension NanoCrystal Dispersion|Subjects were treated with 575 mg per day as single dose for 12 weeks
1070537|NCT00637494|B3|Baseline|Total|Total of all reporting groups
1070538|NCT00637494|B2|Baseline|Matching Placebo|Matching placebo on Days 1-7 and a single-study approved antidepressant on Days 8-56
1070539|NCT00637494|B1|Baseline|Mifepristone Followed by an Antidepressant|Mifepristone 1200 mg/day on Days 1-7 and a single-study approved antidepressant on Days 8-56
1070540|NCT00637494|P2|Participant Flow|Matching Placebo|Matching placebo on Days 1-7 and a single-study approved antidepressant on Days 8-56
1070541|NCT00637494|P1|Participant Flow|Mifepristone 1200 mg/Day|Mifepristone 1200 mg/day on Days 1-7 and a single-study approved antidepressant on Days 8-56
1070542|NCT00637494|O2|Outcome|Placebo|"Placebo followed by an antidepressant~placebo: Tablets of identical appearance to active drug, once a day by mouth for the initial 7 days"
1070543|NCT00637494|O1|Outcome|Active|"Mifepristone followed by an antidepressant~mifepristone: 1200 mg (administered as four 300 mg tablets) once a day by mouth for the initial 7 days"
1070544|NCT00637494|O2|Outcome|Placebo|"Placebo followed by an antidepressant~placebo: Tablets of identical appearance to active drug, once a day by mouth for the initial 7 days"
1070545|NCT00637494|O1|Outcome|Active|"Mifepristone followed by an antidepressant~mifepristone: 1200 mg (administered as four 300 mg tablets) once a day by mouth for the initial 7 days"
1070546|NCT00637494|E2|Reported Event|Matching Placebo|Matching placebo on Days 1-7 and a single-study approved antidepressant on Days 8-56
1070547|NCT00637494|E1|Reported Event|Mifepristone 1200 mg/Day|Mifepristone 1200 mg/day on Days 1-7 and a single-study approved antidepressant on Days 8-56
1070548|NCT00637416|B3|Baseline|Total|Total of all reporting groups
1070549|NCT00637416|B2|Baseline|Placebo and Dietary Control|"Dietary control and placebo~Placebo: placebo taken by mouth daily for 3 months"
1070550|NCT00637416|B1|Baseline|Lansoprazole and Dietary Control|"Lansoprazole and dietary control~Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months"
1070551|NCT00637416|P2|Participant Flow|Placebo and Dietary Control|"Dietary control and placebo~Placebo: placebo taken by mouth daily for 3 months"
1070552|NCT00637416|P1|Participant Flow|Lansoprazole and Dietary Control|"Lansoprazole and dietary control~Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months"
1070553|NCT00637416|O2|Outcome|Placebo and Dietary Control|"Dietary control and placebo~Placebo: placebo taken by mouth daily for 3 months"
1070554|NCT00637416|O1|Outcome|Lansoprazole and Dietary Control|"Lansoprazole and dietary control~Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months"
1070555|NCT00637416|E2|Reported Event|Placebo and Dietary Control|"Dietary control and placebo~Placebo: placebo taken by mouth daily for 3 months"
1070556|NCT00637416|E1|Reported Event|Lansoprazole and Dietary Control|"Lansoprazole and dietary control~Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months"
1070557|NCT00637377|B5|Baseline|Total|Total of all reporting groups
1070558|NCT00637377|B4|Baseline|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1070559|NCT00637377|B3|Baseline|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1070560|NCT00637377|B2|Baseline|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1070561|NCT00637377|B1|Baseline|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1070562|NCT00637377|P4|Participant Flow|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1070563|NCT00637377|P3|Participant Flow|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1070564|NCT00637377|P2|Participant Flow|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1070565|NCT00637377|P1|Participant Flow|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1070632|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
1070933|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
1070566|NCT00637377|O4|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1070567|NCT00637377|O3|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1070568|NCT00637377|O2|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1070569|NCT00637377|O1|Outcome|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1070570|NCT00637377|O4|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1070571|NCT00637377|O3|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1070572|NCT00637377|O2|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1070573|NCT00637377|O1|Outcome|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1070574|NCT00637377|O4|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1070575|NCT00637377|O3|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1070576|NCT00637377|O2|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1070577|NCT00637377|O1|Outcome|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1070578|NCT00637377|O4|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1070579|NCT00637377|O3|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1070580|NCT00637377|O2|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1070581|NCT00637377|O1|Outcome|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1070582|NCT00637377|O4|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1070583|NCT00637377|O3|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1070584|NCT00637377|O2|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1070585|NCT00637377|O1|Outcome|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1070586|NCT00637377|E4|Reported Event|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8|Participants received a dose of 2.0 mg Aflibercept Injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year (IVT injection) and were to receive sham injections at interim monthly visits. During the second year, participants received 2.0 mg aflibercept as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1070633|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
1070587|NCT00637377|E3|Reported Event|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Participants received a dose of 0.5 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1070588|NCT00637377|E2|Reported Event|Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4|Participants received a dose of 2.0 mg Aflibercept Injection every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1070589|NCT00637377|E1|Reported Event|Ranibizumab 0.5mg Q4|Participants received a dose of 0.5 mg Ranibizumab every 4 weeks for the first year (intravitreal [IVT] injection). Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1070590|NCT00637312|B3|Baseline|Total|Total of all reporting groups
1070591|NCT00637312|B2|Baseline|Standard Care - Control|Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System
1070592|NCT00637312|B1|Baseline|Advent™ Cervical Disc|Cervical artificial disc replacement: Advent™ Cervical Disc
1070593|NCT00637312|P2|Participant Flow|Standard Care - Control|Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System
1070594|NCT00637312|P1|Participant Flow|Advent™ Cervical Disc|Cervical artificial disc replacement: Advent™ Cervical Disc
1070595|NCT00637312|O2|Outcome|Standard Care - Control|Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System
1070596|NCT00637312|O1|Outcome|Advent™ Cervical Disc|Cervical artificial disc replacement: Advent™ Cervical Disc
1070597|NCT00637312|E2|Reported Event|Standard Care - Control|Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System
1070598|NCT00637312|E1|Reported Event|Advent™ Cervical Disc|Cervical artificial disc replacement: Advent™ Cervical Disc
1070599|NCT00637299|B3|Baseline|Total|Total of all reporting groups
1070600|NCT00637299|B2|Baseline|Sham Osteopathic Treatment (Manipulation)|Sham Osteopathic Treatment was performed applying only soft manipulation
1070601|NCT00637299|B1|Baseline|Active Osteopathic Treatment|OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner.
1070602|NCT00637299|P2|Participant Flow|Sham Osteopathic Treatment (Manipulation)|Sham Osteopathic Treatment was performed applying only soft manipulation
1070603|NCT00637299|P1|Participant Flow|Active Osteopathic Treatment|OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner.
1070604|NCT00637299|O2|Outcome|Sham Osteopathic Treatment (Manipulation)|Sham Osteopathic Treatment was performed applying only soft manipulation
1070605|NCT00637299|O1|Outcome|Active Osteopathic Treatment|OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner.
1070606|NCT00637299|O2|Outcome|Sham Osteopathic Treatment (Manipulation)|Sham Osteopathic Treatment was performed applying only soft manipulation
1070607|NCT00637299|O1|Outcome|Active Osteopathic Treatment|OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner.
1070608|NCT00637299|E2|Reported Event|Sham Osteopathic Treatment (Manipulation)|Sham Osteopathic Treatment was performed applying only soft manipulation
1070609|NCT00637299|E1|Reported Event|Active Osteopathic Treatment|OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner.
1070610|NCT00637273|B4|Baseline|Total|Total of all reporting groups
1070611|NCT00637273|B3|Baseline|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
1070612|NCT00637273|B2|Baseline|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
1070613|NCT00637273|B1|Baseline|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
1070614|NCT00637273|P3|Participant Flow|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
1070615|NCT00637273|P2|Participant Flow|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
1070616|NCT00637273|P1|Participant Flow|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
1070617|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
1070618|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
1070619|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
1070620|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
1070621|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
1070622|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
1070623|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
1070624|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
1070625|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
1070626|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
1070627|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
1070628|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
1070629|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
1070630|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
1070631|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
1074162|NCT00628862|P3|Participant Flow|Placebo|Placebo
1070634|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
1070635|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
1070636|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
1070637|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
1070638|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
1070639|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
1070640|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
1070641|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
1070642|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
1070643|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
1070644|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
1070645|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
1070646|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
1070647|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
1070648|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
1070649|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
1070650|NCT00637273|O3|Outcome|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
1070651|NCT00637273|O2|Outcome|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
1070652|NCT00637273|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
1070653|NCT00637273|E3|Reported Event|Pioglitazone|Pioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
1070654|NCT00637273|E2|Reported Event|Sitagliptin|Sitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly
1070655|NCT00637273|E1|Reported Event|Exenatide Once Weekly|Exenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning
1070656|NCT00637247|B3|Baseline|Total|Total of all reporting groups
1070657|NCT00637247|B2|Baseline|Imexon Placebo + Gemcitabine|Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2
1070658|NCT00637247|B1|Baseline|Amplimexon (Imexon) + Gemcitabine|Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2
1070659|NCT00637247|P2|Participant Flow|Imexon Placebo + Gemcitabine|Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2
1070660|NCT00637247|P1|Participant Flow|Amplimexon (Imexon) + Gemcitabine|Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2
1070661|NCT00637247|O2|Outcome|Imexon Placebo + Gemcitabine|Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2
1070662|NCT00637247|O1|Outcome|Amplimexon (Imexon) + Gemcitabine|Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2
1070663|NCT00637247|O2|Outcome|Imexon Placebo + Gemcitabine|Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2
1070664|NCT00637247|O1|Outcome|Amplimexon (Imexon) + Gemcitabine|Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2
1070665|NCT00637247|O2|Outcome|Imexon Placebo + Gemcitabine|Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2
1070666|NCT00637247|O1|Outcome|Amplimexon (Imexon) + Gemcitabine|Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2
1070667|NCT00637247|E2|Reported Event|Imexon Placebo + Gemcitabine|Placebo 875 mg/m^2+ gemcitabine 1000 mg/m^2
1070668|NCT00637247|E1|Reported Event|Amplimexon (Imexon) + Gemcitabine|Amplimexon 875 mg/m^2 + gemcitabine 1000 mg/m^2
1070669|NCT00637195|B3|Baseline|Total|Total of all reporting groups
1070670|NCT00637195|B2|Baseline|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
1070671|NCT00637195|B1|Baseline|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
1070672|NCT00637195|P2|Participant Flow|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
1070673|NCT00637195|P1|Participant Flow|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
1070674|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
1070675|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
1070676|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
1070677|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
1070678|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
1070679|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
1070680|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
1070681|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
1070683|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
1070684|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
1070685|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
1070686|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
1070687|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
1070688|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
1070689|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
1070690|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
1070691|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
1070692|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
1070693|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
1070694|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
1070695|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
1070696|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
1070697|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
1070698|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
1070699|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
1070700|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
1070701|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
1070702|NCT00637195|O2|Outcome|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
1070703|NCT00637195|O1|Outcome|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
1070704|NCT00637195|E2|Reported Event|Engerix™ Group|Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
1070705|NCT00637195|E1|Reported Event|Cervarix™ & Engerix™ Group|Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
1070706|NCT00637156|B3|Baseline|Total|Total of all reporting groups
1070707|NCT00637156|B2|Baseline|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
1070708|NCT00637156|B1|Baseline|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
1070709|NCT00637156|P2|Participant Flow|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
1070710|NCT00637156|P1|Participant Flow|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
1070711|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
1070712|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
1070713|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
1070714|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
1070715|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
1070716|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
1070717|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
1070718|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
1070719|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
1070720|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
1070721|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
1070722|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
1070723|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
1070724|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
1070725|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
1070726|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
1070727|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
1070728|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
1070729|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
1070730|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
1070731|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
1070732|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
1070733|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
1070734|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
1070735|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
1070736|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
1070737|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
1070738|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
1070739|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
1070740|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
1070741|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
1070742|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
1070934|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
1070743|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
1070744|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
1070745|NCT00637156|O2|Outcome|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
1070746|NCT00637156|O1|Outcome|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
1070747|NCT00637156|E2|Reported Event|ATLANTIS Cervical Plate System|Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
1070748|NCT00637156|E1|Reported Event|PRESTIGE LP Device|PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
1070749|NCT00637000|B3|Baseline|Total|Total of all reporting groups
1070750|NCT00637000|B2|Baseline|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070751|NCT00637000|B1|Baseline|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070752|NCT00637000|P2|Participant Flow|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070753|NCT00637000|P1|Participant Flow|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070754|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070755|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070756|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070757|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070758|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070759|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070760|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070761|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070762|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070763|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070764|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070935|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
1070765|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070766|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070767|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070768|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070769|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070770|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070771|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070772|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070773|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070774|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070775|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070776|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070777|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070778|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070779|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070780|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070781|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070782|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070783|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070784|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070936|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
1070785|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070786|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070787|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070788|NCT00637000|O2|Outcome|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070789|NCT00637000|O1|Outcome|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070790|NCT00637000|E2|Reported Event|Sublingual Buprenorphine/Naloxone Soluble Film|"Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070791|NCT00637000|E1|Reported Event|Sublingual Buprenorphine Soluble Film|"Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours.~Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours."
1070792|NCT00636987|B1|Baseline|Implanted With Biocor or Biocor Supra Valves|Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
1070793|NCT00636987|P1|Participant Flow|Implanted With Biocor or Biocor Supra Valves|Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
1070794|NCT00636987|O3|Outcome|Biocor Mitral Valve|
1070795|NCT00636987|O2|Outcome|Biocor Supra Valve|
1070796|NCT00636987|O1|Outcome|Biocor Valve|Biocor valves: Replacement for a diseased, damaged, malformed aortic heart valve
1070797|NCT00636987|O1|Outcome|Implanted With Biocor or Biocor Supra Valves|Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
1070798|NCT00636987|O1|Outcome|Implanted With Biocor, Biocor Supra, Biocor Mitral Valves|Biocor (aortic), Biocor Supra (aortic) and Biocor Mitral valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
1070799|NCT00636987|E1|Reported Event|Implanted With Biocor or Biocor Supra Valves|Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
1070800|NCT00636961|B3|Baseline|Total|Total of all reporting groups
1070801|NCT00636961|B2|Baseline|Sequence 2 : Placebo Followed by Indacaterol 300μg|In period I, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study.
1070802|NCT00636961|B1|Baseline|Sequence 1: Indacaterol 300μg Followed by Placebo|In period I, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study.
1070803|NCT00636961|P2|Participant Flow|Sequence 2 : Placebo Followed by Indacaterol 300μg|In period I, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study.
1070804|NCT00636961|P1|Participant Flow|Sequence 1: Indacaterol 300μg Followed by Placebo|In period I, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study.
1070805|NCT00636961|O2|Outcome|Placebo|Patients received matching placebo via the Concept 1 inhaler device once daily in the morning (between 7 am to 12am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
1070806|NCT00636961|O1|Outcome|Indacaterol 300ug|Patients received indacaterol 300μg via the Concept 1 inhaler device once daily (between 7 am and 12 am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
1070807|NCT00636961|O2|Outcome|Placebo|Patients received matching placebo via the Concept 1 inhaler device once daily in the morning (between 7 am to 12am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
1070808|NCT00636961|O1|Outcome|Indacaterol 300ug|Patients received indacaterol 300μg via the Concept 1 inhaler device once daily (between 7 am and 12 am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
1070809|NCT00636961|O2|Outcome|Placebo|Patients received matching placebo via the Concept 1 inhaler device once daily in the morning (between 7 am to 12am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
1070810|NCT00636961|O1|Outcome|Indacaterol 300ug|Patients received indacaterol 300μg via the Concept 1 inhaler device once daily (between 7 am and 12 am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
1070811|NCT00636961|O2|Outcome|Placebo|Patients received matching placebo via the Concept 1 inhaler device once daily in the morning (between 7 am to 12am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
1070812|NCT00636961|O1|Outcome|Indacaterol 300ug|Patients received indacaterol 300μg via the Concept 1 inhaler device once daily (between 7 am and 12 am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
1070813|NCT00636961|O2|Outcome|Placebo|Patients received matching placebo via the Concept 1 inhaler device once daily in the morning (between 7 am to 12am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
1070814|NCT00636961|O1|Outcome|Indacaterol 300ug|Patients received indacaterol 300μg via the Concept 1 inhaler device once daily (between 7 am and 12 am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
1070815|NCT00636961|E2|Reported Event|Placebo|Patients received matching placebo via the Concept 1 inhaler device once daily in the morning (between 7 am to 12am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
1070816|NCT00636961|E1|Reported Event|Indacaterol 300ug|Patients received indacaterol 300μg via the Concept 1 inhaler device once daily (between 7 am and 12 am) for 2 weeks. Rescue medication (SABA) was prescribed by the investigator for the duration of the study.
1070817|NCT00636818|B1|Baseline|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
1070818|NCT00636818|P1|Participant Flow|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
1070819|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
1070820|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
1070821|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
1070822|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
1070823|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
1070824|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
1070825|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
1070826|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
1070827|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
1070828|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
1070829|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
1070830|NCT00636818|O1|Outcome|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
1070831|NCT00636818|E1|Reported Event|Atomoxetine|Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
1070832|NCT00636805|B1|Baseline|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
1070833|NCT00636805|P1|Participant Flow|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
1070834|NCT00636805|O1|Outcome|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
1070835|NCT00636805|O1|Outcome|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
1070836|NCT00636805|O1|Outcome|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
1070837|NCT00636805|O1|Outcome|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
1070838|NCT00636805|O1|Outcome|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
1070839|NCT00636805|O1|Outcome|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
1070840|NCT00636805|O1|Outcome|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
1070841|NCT00636805|E1|Reported Event|Patient Receives IV Aloxi|"Patient receives IV Aloxi~Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy."
1070842|NCT00636792|B1|Baseline|VELCADE, Bendamustine, Rituximab (VBR) Treatment|Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 of each 35-day cycle; bendamustine 50-90 mg/m^2 IV on days 1 and 2 of each cycle; rituximab 375 mg/m^2 IV on days 1, 8, 15 and 22 of cycle 1 and on day1 of cycles 2, 3, 4, and 5. Total treatment duration is 5 cycles.
1070843|NCT00636792|P1|Participant Flow|VELCADE, Bendamustine, Rituximab (VBR) Treatment|Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 of each 35-day cycle; bendamustine 50-90 mg/m^2 IV on days 1 and 2 of each cycle; rituximab 375 mg/m^2 IV on days 1, 8, 15 and 22 of cycle 1 and on day1 of cycles 2, 3, 4, and 5. Total treatment duration is 5 cycles.
1070844|NCT00636792|O1|Outcome|VELCADE, Bendamustine, Rituximab (VBR) Treatment|Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 of each 35-day cycle; bendamustine 50-90 mg/m^2 IV on days 1 and 2 of each cycle; rituximab 375 mg/m^2 IV on days 1, 8, 15 and 22 of cycle 1 and on day1 of cycles 2, 3, 4, and 5. Total treatment duration is 5 cycles.
1070845|NCT00636792|O1|Outcome|VELCADE, Bendamustine, Rituximab (VBR) Treatment|Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 of each 35-day cycle; bendamustine 50-90 mg/m^2 IV on days 1 and 2 of each cycle; rituximab 375 mg/m^2 IV on days 1, 8, 15 and 22 of cycle 1 and on day1 of cycles 2, 3, 4, and 5. Total treatment duration is 5 cycles.
1070846|NCT00636792|E1|Reported Event|VELCADE, Bendamustine, Rituximab (VBR) Treatment|Patients receive bortezomib 1.6 mg/m^2 IV on days 1, 8, 15, and 22 of each 35-day cycle; bendamustine 50-90 mg/m^2 IV on days 1 and 2 of each cycle; rituximab 375 mg/m^2 IV on days 1, 8, 15 and 22 of cycle 1 and on day1 of cycles 2, 3, 4, and 5. Total treatment duration is 5 cycles.
1070847|NCT00636701|B3|Baseline|Total|Total of all reporting groups
1070848|NCT00636701|B2|Baseline|Arm 2|"Receive sham rTMS (Repetitive Transcranial Magnetic Stimulation)~Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes"
1070849|NCT00636701|B1|Baseline|Arm 1|"Receive rTMS (Repetitive Transcranial Magnetic Stimulation)~Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes"
1070850|NCT00636701|P2|Participant Flow|Arm 2|"Receive sham rTMS (Repetitive Transcranial Magnetic Stimulation)~Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes"
1070851|NCT00636701|P1|Participant Flow|Arm 1|"Receive rTMS (Repetitive Transcranial Magnetic Stimulation)~Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes"
1070852|NCT00636701|O2|Outcome|Number of Participants Who Received Unprimed rTMS|Number of participants who received 10 min. of sham rTMS Repetitive Transcranial Magnetic Stimulation. Followed by 30 min. of 1-Hz rTMS at 95% RMT (1,880 pulses)
1070853|NCT00636701|O1|Outcome|Number of Participants Who Received Primed rTMS|Number of participants who received 10 min. of 6-Hz rTMS Repetitive Transcranial Magnetic Stimulation at 90% RMT (3,600 pulses). Followed by 30 min. of 1-Hz rTMS at 95% RMT (1,880 pulses)
1070854|NCT00636701|E2|Reported Event|Arm 2|"Receive sham rTMS (Repetitive Transcranial Magnetic Stimulation)~Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes"
1070855|NCT00636701|E1|Reported Event|Arm 1|"Receive rTMS (Repetitive Transcranial Magnetic Stimulation)~Repetitive Transcranial Magnetic Stimulation: We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes"
1070856|NCT00636649|B3|Baseline|Total|Total of all reporting groups
1070857|NCT00636649|B2|Baseline|Placebo|
1070858|NCT00636649|B1|Baseline|Escitalopram|
1070859|NCT00636649|P2|Participant Flow|Placebo|Dosing of matching placebo was identical.
1070860|NCT00636649|P1|Participant Flow|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
1070861|NCT00636649|O2|Outcome|Placebo|Dosing of matching placebo was identical.
1070862|NCT00636649|O1|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
1070863|NCT00636649|O2|Outcome|Placebo|Dosing of matching placebo was identical.
1070864|NCT00636649|O1|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
1070865|NCT00636649|O2|Outcome|Placebo|Dosing of matching placebo was identical.
1070866|NCT00636649|O1|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
1070867|NCT00636649|O2|Outcome|Placebo|Dosing of matching placebo was identical.
1070868|NCT00636649|O1|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
1070869|NCT00636649|O2|Outcome|Placebo|Dosing of matching placebo was identical.
1070870|NCT00636649|O1|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
1070871|NCT00636649|O2|Outcome|Placebo|Dosing of matching placebo was identical.
1070872|NCT00636649|O1|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
1070873|NCT00636649|O2|Outcome|Placebo|Dosing of matching placebo was identical.
1070874|NCT00636649|O1|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
1070875|NCT00636649|O2|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
1070876|NCT00636649|O1|Outcome|Placebo|Dosing of matching placebo was identical.
1070877|NCT00636649|O2|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
1070878|NCT00636649|O1|Outcome|Placebo|Dosing of matching placebo was identical.
1070879|NCT00636649|O2|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
1070880|NCT00636649|O1|Outcome|Placebo|Dosing of matching placebo was identical.
1070881|NCT00636649|O2|Outcome|Placebo|Dosing of matching placebo was identical.
1070882|NCT00636649|O1|Outcome|Escitalopram|Escitalopram was started at 10 mg/d and the dose was increased to 20 mg/d after 4 weeks.
1070883|NCT00636649|O2|Outcome|Placebo|
1070884|NCT00636649|O1|Outcome|Escitalopram|
1070885|NCT00636649|E2|Reported Event|Placebo|
1070886|NCT00636649|E1|Reported Event|Escitalopram|
1070887|NCT00636636|B3|Baseline|Total|Total of all reporting groups
1070888|NCT00636636|B2|Baseline|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
1070889|NCT00636636|B1|Baseline|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
1070890|NCT00636636|P2|Participant Flow|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
1070891|NCT00636636|P1|Participant Flow|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
1070892|NCT00636636|O2|Outcome|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
1070893|NCT00636636|O1|Outcome|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
1070894|NCT00636636|O2|Outcome|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
1070895|NCT00636636|O1|Outcome|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
1070896|NCT00636636|O2|Outcome|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
1070897|NCT00636636|O1|Outcome|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
1070898|NCT00636636|O2|Outcome|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
1070899|NCT00636636|O1|Outcome|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
1070900|NCT00636636|O2|Outcome|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
1070901|NCT00636636|O1|Outcome|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
1070902|NCT00636636|E2|Reported Event|Placebo|Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing
1070903|NCT00636636|E1|Reported Event|G-ER|Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing
1070904|NCT00636610|B3|Baseline|Total|Total of all reporting groups
1070905|NCT00636610|B2|Baseline|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily starting on Day 3 of each 2-week treatment. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
1070930|NCT00636441|P2|Participant Flow|Guided TC Sensitive|"Genomically-guided treatment >60% probability of response to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
1070931|NCT00636441|P1|Participant Flow|Guided AC Sensitive|"Genomically-guided >60% probability of response to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
1070906|NCT00636610|B1|Baseline|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily starting on Day 3 of each 2-week treatment cycle. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
1070907|NCT00636610|P2|Participant Flow|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily starting on Day 3 of each 2-week treatment. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
1070908|NCT00636610|P1|Participant Flow|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily starting on Day 3 of each 2-week treatment cycle. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
1070909|NCT00636610|O2|Outcome|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily starting on Day 3 of each 2-week treatment. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
1070910|NCT00636610|O1|Outcome|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily starting on Day 3 of each 2-week treatment cycle. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
1070911|NCT00636610|O2|Outcome|Placebo to Vismodegib|Patients received placebo to vismodegib orally once daily starting on Day 3 of each 2-week treatment. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
1070912|NCT00636610|O1|Outcome|Vismodegib 150 mg|Patients received vismodegib 150 mg orally once daily starting on Day 3 of each 2-week treatment cycle. In addition, patients received either Modified FOLFOX (FOL=leucovorin calcium [folinic acid], F=fluorouracil, OX=oxaliplatin) + bevacizumab or FOLFIRI (FOL=leucovorin calcium [folinic acid] F=fluorouracil, IRI=irinotecan hydrochloride) + bevacizumab on Days 1-3 of each 2-week treatment cycle. The decision of which regimen (FOLFOX or FOLFIRI) to use was made by the treating physician and patient.
1070913|NCT00636610|E4|Reported Event|Vismodegib (GDC-0449) With FOLFIRI+Bevacizumab|GDC-0449 (150 mg) will be administered beginning on Cycle 1, Day 3 once daily by oral dosing. For Cycles 2 and beyond, GDC-0449 will be administered once daily beginning on Day 1.
1070914|NCT00636610|E3|Reported Event|Placebo With FOLFIRI+Bevacizumab|Placebo will be administered beginning on Cycle 1, Day 3 once daily by oral dosing. For Cycles 2 and beyond, placebo will be administered once daily beginning on Day 1.
1070915|NCT00636610|E2|Reported Event|Vismodegib (GDC-0449) With FOLFOX+Bevacizumab|GDC-0449 (150 mg) will be administered beginning on Cycle 1, Day 3 once daily by oral dosing. For Cycles 2 and beyond, GDC-0449 will be administered once daily beginning on Day 1.
1070916|NCT00636610|E1|Reported Event|Placebo With FOLFOX+Bevacizumab|Placebo will be administered beginning on Cycle 1, Day 3 once daily by oral dosing. For Cycles 2 and beyond, placebo will be administered once daily beginning on Day 1.
1070917|NCT00636441|B8|Baseline|Total|Total of all reporting groups
1070918|NCT00636441|B7|Baseline|Screen Failure|
1070919|NCT00636441|B6|Baseline|Non-guided TC|"Non-genomics guided treatment; randomized to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
1070920|NCT00636441|B5|Baseline|Non-guided AC|"Non-genomics guided treatment; randomized to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
1070921|NCT00636441|B4|Baseline|Guided TC Non-Sensitive|"Genomics guided treatment <60% probability of response to both AC and TC; randomized to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
1070922|NCT00636441|B3|Baseline|Guided AC Non-sensitive|"Genomics guided treatment <60% probability of response to both AC and TC; randomized to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
1070923|NCT00636441|B2|Baseline|Guided TC Sensitive|"Genomically-guided treatment >60% probability of response to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
1070924|NCT00636441|B1|Baseline|Guided AC Sensitive|"Genomically-guided >60% probability of response to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
1070925|NCT00636441|P7|Participant Flow|Screen Failure|
1070926|NCT00636441|P6|Participant Flow|Non-guided TC|"Non-genomics guided treatment; randomized to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
1070927|NCT00636441|P5|Participant Flow|Non-guided AC|"Non-genomics guided treatment; randomized to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
1070928|NCT00636441|P4|Participant Flow|Guided TC Non-Sensitive|"Genomics guided treatment <60% probability of response to both AC and TC; randomized to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
1070929|NCT00636441|P3|Participant Flow|Guided AC Non-sensitive|"Genomics guided treatment <60% probability of response to both AC and TC; randomized to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
1070937|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
1070938|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
1070939|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
1070940|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
1070941|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
1070942|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
1070943|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
1070944|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
1070945|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
1070946|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
1070947|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
1070948|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
1070949|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
1070950|NCT00636441|O2|Outcome|Non-Guided Arm|Non-genomically-guided treatment allocation.
1070951|NCT00636441|O1|Outcome|Guided Arm|Genomically-guided treatment allocation.
1070952|NCT00636441|E7|Reported Event|Screen Failures|Screen failures constitute patients who were registered to the study but were not assigned treatment for various reasons.
1070953|NCT00636441|E6|Reported Event|Non-guided TC|"Non-genomics guided treatment; randomized to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
1070954|NCT00636441|E5|Reported Event|Non-guided AC|"Non-genomics guided treatment; randomized to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
1070955|NCT00636441|E4|Reported Event|Guided TC Non-Sensitive|"Genomics guided treatment <60% probability of response to both AC and TC; randomized to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
1070956|NCT00636441|E3|Reported Event|Guided AC Non-sensitive|"Genomics guided treatment <60% probability of response to both AC and TC; randomized to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
1070957|NCT00636441|E2|Reported Event|Guided TC Sensitive|"Genomically-guided treatment >60% probability of response to TC~TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy"
1070958|NCT00636441|E1|Reported Event|Guided AC Sensitive|"Genomically-guided >60% probability of response to AC~AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy"
1070959|NCT00636389|B1|Baseline|All Study Participants|
1070960|NCT00636389|P2|Participant Flow|210H First (Period 1), Then HD-C4 (Period 2)|Subjects were randomly assigned to begin the first week (Period 1)of three consecutive treatments with the Polyflux 210H dialyzer. Following the third treatment, the subjects were switched to the Polyflux HD-C4 dialyzer for a second week (Period 2) of three consecutive treatments. Therefore each subject had a total of six consecutive dialysis treatments.
1070961|NCT00636389|P1|Participant Flow|HD-C4 First (Period 1), Then 210H (Period 2)|Subjects were randomly assigned to begin the first week (Period 1) of three consecutive treatments with the Polyflux HD-C4 dialyzer. Following the third treatment, the subjects were switched to the Polyflux 210H dialyzer for a second week (Period 2) of three consecutive treatments. Therefore each subject had a total of six consecutive dialysis treatments.
1070962|NCT00636389|O2|Outcome|210H|
1070963|NCT00636389|O1|Outcome|HD-C4|
1070964|NCT00636389|O2|Outcome|210H|
1070965|NCT00636389|O1|Outcome|HD-C4|
1070966|NCT00636389|O2|Outcome|210H|
1070967|NCT00636389|O1|Outcome|HD-C4|
1070968|NCT00636389|E2|Reported Event|210H First (Period 1), Then HD-C4 (Period 2)|Subjects were randomly assigned to begin the first week (Period 1)of three consecutive treatments with the Polyflux 210H dialyzer. Following the third treatment, the subjects were switched to the Polyflux HD-C4 dialyzer for a second week (Period 2) of three consecutive treatments. Therefore each subject had a total of six consecutive dialysis treatments.
1070969|NCT00636389|E1|Reported Event|HD-C4 First (Period 1), Then 210H (Period 2)|Subjects were randomly assigned to begin the first week (Period 1) of three consecutive treatments with the Polyflux HD-C4 dialyzer. Following the third treatment, the subjects were switched to the Polyflux 210H dialyzer for a second week (Period 2) of three consecutive treatments. Therefore each subject had a total of six consecutive dialysis treatments.
1070970|NCT00636363|B4|Baseline|Total|Total of all reporting groups
1070971|NCT00636363|B3|Baseline|Ciba Vision Aquify Multipurpose Solution|Ciba Vision Aquify Multipurpose Solution for use with contact lens care
1070972|NCT00636363|B2|Baseline|Multipurpose Solution - No Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
1070973|NCT00636363|B1|Baseline|Multipurpose Solution - Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
1070974|NCT00636363|P3|Participant Flow|Ciba Vision Aquify Multipurpose Solution|Ciba Vision Aquify Multipurpose Solution for use with contact lens care
1070975|NCT00636363|P2|Participant Flow|Multipurpose Solution - No Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
1070976|NCT00636363|P1|Participant Flow|Multipurpose Solution - Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
1070977|NCT00636363|O3|Outcome|Ciba Vision Aquify Multipurpose Solution|Ciba Vision Aquify Multipurpose Solution for use with contact lens care
1070978|NCT00636363|O2|Outcome|Multipurpose Solution - No Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
1070979|NCT00636363|O1|Outcome|Multipurpose Solution - Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
1070980|NCT00636363|O3|Outcome|Ciba Vision Aquify Multipurpose Solution|Ciba Vision Aquify Multipurpose Solution for use with contact lens care
1070981|NCT00636363|O2|Outcome|Multipurpose Solution - No Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
1070982|NCT00636363|O1|Outcome|Multipurpose Solution - Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
1070983|NCT00636363|O3|Outcome|Ciba Vision Aquify Multipurpose Solution|Ciba Vision Aquify Multipurpose Solution for use with contact lens care
1070984|NCT00636363|O2|Outcome|Multipurpose Solution - No Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
1070985|NCT00636363|O1|Outcome|Multipurpose Solution - Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
1070986|NCT00636363|E3|Reported Event|Ciba Vision Aquify Multipurpose Solution|Ciba Vision Aquify Multipurpose Solution for use with contact lens care
1070987|NCT00636363|E2|Reported Event|Multipurpose Solution - No Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
1070988|NCT00636363|E1|Reported Event|Multipurpose Solution - Rub Care|Bausch & Lomb Multipurpose Solution for use with contact lens care
1070989|NCT00636220|B1|Baseline|Confirmed HIV Infection|participants with known (clinically or serologically) confirmed HIV infection.
1070990|NCT00636220|P1|Participant Flow|Confirmed HIV Infection|The study population will consist of 100 participants with known (clinically or serologically) confirmed HIV infection.
1070991|NCT00636220|O1|Outcome|Confirmed HIV Infection|The study population will consist of 100 participants with known (clinically or serologically) confirmed HIV infection.
1070992|NCT00636220|E1|Reported Event|Confirmed HIV Infection|The study population will consist of 100 participants with known (clinically or serologically) confirmed HIV infection.
1070993|NCT00636207|B4|Baseline|Total|Total of all reporting groups
1070994|NCT00636207|B3|Baseline|Part III|Part III consisted of 2 periods. Participants in two serial panels (Panels A and B) were to receive QD doses of inhaled Montelukast (3 mg or 10 mg) or Placebo administered for 10 consecutive days. Each panel was separated by at least a 7-day washout period.
1070995|NCT00636207|B2|Baseline|Part II|Part II consisted of 3 periods. Participants in three serial panels (Panels A, B and C) were to receive once daily (QD) doses of inhaled Montelukast (1 mg, 3 mg or 10 mg) or Placebo administered for 5 consecutive days. Each panel was separated by at least a 3-day washout period.
1070996|NCT00636207|B1|Baseline|Part I|Part I consisted of 6 periods. Participants were to receive single doses of inhaled Montelukast (0.1 mg, 0.3 mg, 0.3 repeat, 1 mg, 3 mg or 10 mg) or Placebo. Each dose was separated by at least a 3-day washout period.
1070997|NCT00636207|P7|Participant Flow|Part III - Placebo|Part III consisted of 2 periods. Participants in two serial panels (Panels A and B) were to receive QD doses of inhaled or Placebo administered for 10 consecutive days. Each panel was separated by at least a 7-day washout period.
1070998|NCT00636207|P6|Participant Flow|Part III - Montelukast and Placebo|Part III consisted of 2 periods. Participants in two serial panels (Panels A and B) were to receive QD doses of inhaled Montelukast (3 mg or 10 mg) or Placebo administered for 10 consecutive days. Each panel was separated by at least a 7-day washout period.
1070999|NCT00636207|P5|Participant Flow|Part III - Montelukast|Part III consisted of 2 periods. Participants in two serial panels (Panels A and B) were to receive QD doses of inhaled Montelukast (3 mg or 10 mg) administered for 10 consecutive days. Each panel was separated by at least a 7-day washout period.
1071000|NCT00636207|P4|Participant Flow|Part II - Placebo|Part II consisted of 3 periods. Participants in three serial panels (Panels A, B and C) were to receive QD doses of inhaled Placebo administered for 5 consecutive days. Each panel was separated by at least a 3-day washout period.
1071001|NCT00636207|P3|Participant Flow|Part II - Montelukast|Part II consisted of 3 periods. Participants in three serial panels (Panels A, B and C) were to receive once daily (QD) doses of inhaled Montelukast (1 mg, 3 mg or 10 mg) administered for 5 consecutive days. Each panel was separated by at least a 3-day washout period.
1071002|NCT00636207|P2|Participant Flow|Part I - Montelukast and Placebo|Part I consisted of 6 periods. Participants were to receive single doses of inhaled Montelukast (0.1 mg, 0.3 mg, 0.3 mg repeat, 1 mg, 3 mg or 10 mg) or Placebo. Each dose was separated by at least a 3-day washout period.
1071003|NCT00636207|P1|Participant Flow|Part I - Montelukast|Part I consisted of 6 periods. Participants were to receive single doses of inhaled Montelukast (0.1 mg, 0.3 mg, 0.3 mg repeat, 1 mg, 3 mg or 10 mg). Each dose was separated by at least a 3-day washout period.
1071004|NCT00636207|O3|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder QD
1071005|NCT00636207|O2|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder QD
1071006|NCT00636207|O1|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder QD
1071007|NCT00636207|O3|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder QD
1071008|NCT00636207|O2|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder QD
1071009|NCT00636207|O1|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder QD
1071010|NCT00636207|O3|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder QD
1071011|NCT00636207|O2|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder QD
1071012|NCT00636207|O1|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder QD
1071013|NCT00636207|O6|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder
1071014|NCT00636207|O5|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder
1071015|NCT00636207|O4|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder
1071016|NCT00636207|O3|Outcome|Montelukast 0.3 mg Repeat|Participants receiving Montelukast 0.3 mg inhalation powder
1071017|NCT00636207|O2|Outcome|Montelukast 0.3 mg|Participants receiving Montelukast 0.3 mg inhalation powder
1071018|NCT00636207|O1|Outcome|Montelukast 0.1 mg|Participants receiving Montelukast 0.1 mg inhalation powder
1071019|NCT00636207|O3|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder QD
1071020|NCT00636207|O2|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder QD
1071021|NCT00636207|O1|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder QD
1071022|NCT00636207|O6|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder
1071023|NCT00636207|O5|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder
1071024|NCT00636207|O4|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder
1071025|NCT00636207|O3|Outcome|Montelukast 0.3 mg Repeat|Participants receiving Montelukast 0.3 mg inhalation powder
1071026|NCT00636207|O2|Outcome|Montelukast 0.3 mg|Participants receiving Montelukast 0.3 mg inhalation powder
1071027|NCT00636207|O1|Outcome|Montelukast 0.1 mg|Participants receiving Montelukast 0.1 mg inhalation powder
1071028|NCT00636207|O3|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder QD
1071029|NCT00636207|O2|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder QD
1071030|NCT00636207|O1|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder QD
1071031|NCT00636207|O6|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder
1071032|NCT00636207|O5|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder
1071033|NCT00636207|O4|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder
1071034|NCT00636207|O3|Outcome|Montelukast 0.3 mg Repeat|Participants receiving Montelukast 0.3 mg inhalation powder
1071035|NCT00636207|O2|Outcome|Montelukast 0.3 mg|Participants receiving Montelukast 0.3 mg inhalation powder
1071036|NCT00636207|O1|Outcome|Montelukast 0.1 mg|Participants receiving Montelukast 0.1 mg inhalation powder
1071037|NCT00636207|O3|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder QD
1071038|NCT00636207|O2|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder QD
1071039|NCT00636207|O1|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder QD
1071040|NCT00636207|O6|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder
1071041|NCT00636207|O5|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder
1071042|NCT00636207|O4|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder
1071043|NCT00636207|O3|Outcome|Montelukast 0.3 mg Repeat|Participants receiving Montelukast 0.3 mg inhalation powder
1071044|NCT00636207|O2|Outcome|Montelukast 0.3 mg|Participants receiving Montelukast 0.3 mg inhalation powder
1071045|NCT00636207|O1|Outcome|Montelukast 0.1 mg|Participants receiving Montelukast 0.1 mg inhalation powder
1071046|NCT00636207|O6|Outcome|Placebo|Participants receiving Placebo inhalation powder
1071047|NCT00636207|O5|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder
1071048|NCT00636207|O4|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder
1071049|NCT00636207|O3|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder
1071050|NCT00636207|O2|Outcome|Montelukast 0.3 mg|Participants receiving Montelukast 0.3 mg inhalation powder
1071051|NCT00636207|O1|Outcome|Montelukast 0.1 mg|Participants receiving Montelukast 0.1 mg inhalation powder
1071052|NCT00636207|O6|Outcome|Placebo|Participants receiving Placebo inhalation powder
1071053|NCT00636207|O5|Outcome|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder
1071054|NCT00636207|O4|Outcome|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder
1071055|NCT00636207|O3|Outcome|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder
1071056|NCT00636207|O2|Outcome|Montelukast 0.3 mg|Participants receiving Montelukast 0.3 mg inhalation powder
1071057|NCT00636207|O1|Outcome|Montelukast 0.1 mg|Participants receiving Montelukast 0.1 mg inhalation powder
1071058|NCT00636207|E6|Reported Event|Placebo|Participants receiving Placebo inhalation powder
1071059|NCT00636207|E5|Reported Event|Montelukast 10 mg|Participants receiving Montelukast 10 mg inhalation powder
1071060|NCT00636207|E4|Reported Event|Montelukast 3 mg|Participants receiving Montelukast 3 mg inhalation powder
1071061|NCT00636207|E3|Reported Event|Montelukast 1 mg|Participants receiving Montelukast 1 mg inhalation powder
1071062|NCT00636207|E2|Reported Event|Montelukast 0.3 mg|Participants receiving Montelukast 0.3 mg inhalation powder
1071063|NCT00636207|E1|Reported Event|Montelukast 0.1 mg|Participants receiving Montelukast 0.1 mg inhalation powder
1071064|NCT00636194|B3|Baseline|Total|Total of all reporting groups
1071065|NCT00636194|B2|Baseline|Alcon Multipurpose Solution|Alcon OptiFree Replenish Multipurpose Contact Lens Solution
1071066|NCT00636194|B1|Baseline|B&L Multipurpose Solution|Bausch & Lomb Multipurpose Contact Lens Solution
1071067|NCT00636194|P2|Participant Flow|Alcon Multipurpose Solution|Alcon OptiFree Replenish Multipurpose Contact Lens Solution
1071068|NCT00636194|P1|Participant Flow|B&L Multipurpose Solution|Bausch & Lomb Multipurpose Contact Lens Solution
1071069|NCT00636194|O2|Outcome|Alcon Multipurpose Solution|Alcon OptiFree Replenish Multipurpose Contact Lens Solution
1071070|NCT00636194|O1|Outcome|B&L Multipurpose Solution|Bausch & Lomb Multipurpose Contact Lens Solution
1071071|NCT00636194|O2|Outcome|Alcon Multipurpose Solution|Alcon OptiFree Replenish Multipurpose Contact Lens Solution
1071072|NCT00636194|O1|Outcome|B&L Multipurpose Solution|Bausch & Lomb Multipurpose Contact Lens Solution
1071073|NCT00636194|O2|Outcome|Alcon Multipurpose Solution|Alcon OptiFree Replenish Multipurpose Contact Lens Solution
1071074|NCT00636194|O1|Outcome|B&L Multipurpose Solution|Bausch & Lomb Multipurpose Contact Lens Solution
1071075|NCT00636194|E2|Reported Event|Alcon Multipurpose Solution|Alcon OptiFree Replenish Multipurpose Contact Lens Solution
1071076|NCT00636194|E1|Reported Event|B&L Multipurpose Solution|Bausch & Lomb Multipurpose Contact Lens Solution
1071077|NCT00636168|B3|Baseline|Total|Total of all reporting groups
1071078|NCT00636168|B2|Baseline|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
1071104|NCT00636155|O1|Outcome|All Patients|Patients treated with cenersen, fludarabine, cyclphosphamide and rituximab
1071165|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
1071440|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
1071079|NCT00636168|B1|Baseline|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
1071080|NCT00636168|P2|Participant Flow|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
1071081|NCT00636168|P1|Participant Flow|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
1071082|NCT00636168|O2|Outcome|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
1071083|NCT00636168|O1|Outcome|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
1071084|NCT00636168|O2|Outcome|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
1071085|NCT00636168|O1|Outcome|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
1071086|NCT00636168|O2|Outcome|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
1071087|NCT00636168|O1|Outcome|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
1071088|NCT00636168|O2|Outcome|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
1071089|NCT00636168|O1|Outcome|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
1071163|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
1071090|NCT00636168|O2|Outcome|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
1071091|NCT00636168|O1|Outcome|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
1071092|NCT00636168|O2|Outcome|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
1071093|NCT00636168|O1|Outcome|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
1071094|NCT00636168|O2|Outcome|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
1071095|NCT00636168|O1|Outcome|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
1071096|NCT00636168|O2|Outcome|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
1071097|NCT00636168|O1|Outcome|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
1071098|NCT00636168|E2|Reported Event|Placebo|Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
1071099|NCT00636168|E1|Reported Event|Ipilimumab 10mg/kg|Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156). Treatment started within 7 days from randomization, no later than 13 weeks after surgery and only after the lymphadenectomy was fully healed.
1071100|NCT00636155|B1|Baseline|All Patients|EL625 2.4mg/kg/day as a continuous infusion daily for 4 days combined rituximab 375mg/m2 IV on day 2, fludarabine IV 25mg/m2 over 30 minutes on days 2- 4 and cyclophosphamide IV 250mg/m2 over 1 hour on days 2-4.
1071101|NCT00636155|P1|Participant Flow|All Patients|EL625 2.4mg/kg/day as a continuous infusion daily for 4 days combined rituximab 375mg/m2 IV on day 2, fludarabine IV 25mg/m2 over 30 minutes on days 2- 4 and cyclophosphamide IV 250mg/m2 over 1 hour on days 2-4.
1071102|NCT00636155|O1|Outcome|All Patients|Patients treated with cenersen, fludarabine, cyclphosphamide and rituximab
1071103|NCT00636155|O1|Outcome|All Patients|Patients treated with cenersen, fludarabine, cyclphosphamide and rituximab
1071105|NCT00636155|E1|Reported Event|All Patients|EL625 2.4mg/kg/day as a continuous infusion daily for 4 days combined rituximab 375mg/m2 IV on day 2, fludarabine IV 25mg/m2 over 30 minutes on days 2- 4 and cyclophosphamide IV 250mg/m2 over 1 hour on days 2-4.
1071106|NCT00636077|B1|Baseline|All Study Participants|
1071107|NCT00636077|P4|Participant Flow|Optiflux F200NR First|Patients in this Arm will receive 3 consecutive treatments with the F200NR dialyzer first. For the study each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments).
1071108|NCT00636077|P3|Participant Flow|Optiflux F160NR First|Patients in this Arm will receive 3 consecutive treatments with the F160NR dialyzer first. For the study each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments).
1071109|NCT00636077|P2|Participant Flow|HD-C4 Small First|Patients in this Arm will receive 3 consecutive treatments with the HD-C4 Small dialyzer first. For the study each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments).
1071110|NCT00636077|P1|Participant Flow|HD-C4 Big First|Patients in this Arm will receive 3 consecutive treatments with the HD-C4 Big dialyzer first. For the study each patient will be treated for three consecutive treatments with each of the 4 study dialyzers (total of 12 consecutive treatments).
1071111|NCT00636077|O4|Outcome|F200NR|3 consecutive treatments with the F200NR dialyzer.
1071112|NCT00636077|O3|Outcome|F160NR|3 consecutive treatments with the F160NR dialyzer.
1071113|NCT00636077|O2|Outcome|HD-C4 Small|3 consecutive treatments with the HD-C4 Small dialyzer.
1071114|NCT00636077|O1|Outcome|HD-C4 Big|3 consecutive treatments with the HD-C4 Big dialyzer.
1071115|NCT00636077|O4|Outcome|F200NR|3 consecutive treatments with the F200NR dialyzer.
1071116|NCT00636077|O3|Outcome|F160NR|3 consecutive treatments with the F160NR dialyzer.
1071117|NCT00636077|O2|Outcome|HD-C4 Small|3 consecutive treatments with the HD-C4 Small dialyzer.
1071118|NCT00636077|O1|Outcome|HD-C4 Big|3 consecutive treatments with the HD-C4 Big dialyzer.
1071119|NCT00636077|O4|Outcome|F200NR|3 consecutive treatments with the F200NR dialyzer.
1071120|NCT00636077|O3|Outcome|F160NR|3 consecutive treatments with the F160NR dialyzer.
1071121|NCT00636077|O2|Outcome|HD-C4 Small|3 consecutive treatments with the HD-C4 Small dialyzer.
1071122|NCT00636077|O1|Outcome|HD-C4 Big|3 consecutive treatments with the HD-C4 Big dialyzer.
1071123|NCT00636077|O4|Outcome|F200NR|3 consecutive treatments with the F200NR dialyzer.
1071124|NCT00636077|O3|Outcome|F160NR|3 consecutive treatments with the F160NR dialyzer.
1071125|NCT00636077|O2|Outcome|HD-C4 Small|3 consecutive treatments with the HD-C4 Small dialyzer.
1071126|NCT00636077|O1|Outcome|HD-C4 Big|3 consecutive treatments with the HD-C4 Big dialyzer.
1071127|NCT00636077|O4|Outcome|F200NR|3 consecutive treatments with the F200NR dialyzer.
1071128|NCT00636077|O3|Outcome|F160NR|3 consecutive treatments with the F160NR dialyzer.
1071129|NCT00636077|O2|Outcome|HD-C4 Small|3 consecutive treatments with the HD-C4 Small dialyzer.
1071130|NCT00636077|O1|Outcome|HD-C4 Big|3 consecutive treatments with the HD-C4 Big dialyzer.
1071131|NCT00636077|O4|Outcome|F200NR|3 consecutive treatments with the F200NR dialyzer.
1071132|NCT00636077|O3|Outcome|F160NR|3 consecutive treatments with the F160NR dialyzer.
1071133|NCT00636077|O2|Outcome|HD-C4 Small|3 consecutive treatments with the HD-C4 Small dialyzer.
1071134|NCT00636077|O1|Outcome|HD-C4 Big|3 consecutive treatments with the HD-C4 Big dialyzer.
1071135|NCT00636077|E4|Reported Event|F200NR|3 consecutive treatments with the F200NR dialyzer.
1071136|NCT00636077|E3|Reported Event|F160NR|3 consecutive treatments with the F160NR dialyzer.
1071137|NCT00636077|E2|Reported Event|HD-C4 Small|3 consecutive treatments with the HD-C4 Small dialyzer.
1071138|NCT00636077|E1|Reported Event|HD-C4 Big|3 consecutive treatments with the HD-C4 Big dialyzer.
1071139|NCT00635882|B7|Baseline|Total|Total of all reporting groups
1071140|NCT00635882|B6|Baseline|Placebo|Placebo MDI BID for 14 days
1071141|NCT00635882|B5|Baseline|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
1071142|NCT00635882|B4|Baseline|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
1071143|NCT00635882|B3|Baseline|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
1071144|NCT00635882|B2|Baseline|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
1071145|NCT00635882|B1|Baseline|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
1071146|NCT00635882|P6|Participant Flow|Placebo|Placebo MDI BID for 14 days
1071147|NCT00635882|P5|Participant Flow|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
1071148|NCT00635882|P4|Participant Flow|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
1071149|NCT00635882|P3|Participant Flow|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
1071150|NCT00635882|P2|Participant Flow|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
1071151|NCT00635882|P1|Participant Flow|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
1071152|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
1071153|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
1071154|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
1071155|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
1071156|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
1071157|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
1071158|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
1071159|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
1071160|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
1071161|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
1071162|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
1071166|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
1071167|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
1071168|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
1071169|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
1071170|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
1071171|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
1071172|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
1071173|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
1071174|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
1071175|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
1071176|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
1071177|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
1071178|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
1071179|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
1071180|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
1071181|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
1071182|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
1071183|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
1071184|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
1071185|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
1071186|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
1071187|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
1071188|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
1071189|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
1071190|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
1071191|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
1071192|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
1071193|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
1071194|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
1071195|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
1071196|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
1071197|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
1071198|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
1071199|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
1071200|NCT00635882|O6|Outcome|Placebo|Placebo MDI BID for 14 days
1071201|NCT00635882|O5|Outcome|MF MDI 200 mcg|MF MDI 200 mcg BID for 14 days
1071202|NCT00635882|O4|Outcome|MF DPI 200 mcg|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days
1071203|NCT00635882|O3|Outcome|MF/F MDI 400/10 mcg|MF/F MDI 400/10 mcg BID for 14 days
1071204|NCT00635882|O2|Outcome|MF/F MDI 200/10 mcg|MF/F MDI 200/10 mcg BID for 14 days
1071205|NCT00635882|O1|Outcome|MF/F MDI 100/10 mcg|Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days
1071206|NCT00635882|E6|Reported Event|PLACEBO|
1071207|NCT00635882|E5|Reported Event|MF MDI 200 MCG BID|
1071208|NCT00635882|E4|Reported Event|MF DPI 200 MCG BID|
1071209|NCT00635882|E3|Reported Event|MF/F MDI 400/10 MCG BID|
1071210|NCT00635882|E2|Reported Event|MF/F MDI 200/10 MCG BID|
1071211|NCT00635882|E1|Reported Event|MF/F MDI 100/10 MCG BID|
1071212|NCT00635830|B3|Baseline|Total|Total of all reporting groups
1071213|NCT00635830|B2|Baseline|9 to 17 Years of Age Group|"9 to 17 years of age group was enrolled after the Ethics Review Committee approval of the older group safety data.~Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
1071214|NCT00635830|B1|Baseline|18 to 26 Years of Age Group|"18 to 26 years of age group was enrolled to evaluate safety firstly.~Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
1071215|NCT00635830|P2|Participant Flow|9 to 17 Years of Age Group|"9 to 17 years of age group was enrolled after the Ethics Review Committee approval of the older group safety data.~Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
1071216|NCT00635830|P1|Participant Flow|18 to 26 Years of Age Group|"18 to 26 years of age group was enrolled to evaluate safety firstly.~Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
1071217|NCT00635830|O2|Outcome|9 to 17 Years of Age Group|"9 to 17 years of age group was enrolled after the Ethics Review Committee approval of the older group safety data.~Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
1071218|NCT00635830|O1|Outcome|18 to 26 Years of Age Group|"18 to 26 years of age group was enrolled to evaluate safety firstly.~Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
1071219|NCT00635830|E2|Reported Event|9 to 17 Years of Age Group|"9 to 17 years of age group was enrolled after the Ethics Review Committee approval of the older group safety data.~Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
1071220|NCT00635830|E1|Reported Event|18 to 26 Years of Age Group|"18 to 26 years of age group was enrolled to evaluate safety firstly.~Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine."
1071222|NCT00635817|B4|Baseline|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
1071223|NCT00635817|B3|Baseline|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
1071224|NCT00635817|B2|Baseline|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
1071225|NCT00635817|B1|Baseline|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
1071226|NCT00635817|P4|Participant Flow|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
1071227|NCT00635817|P3|Participant Flow|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
1071228|NCT00635817|P2|Participant Flow|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
1071229|NCT00635817|P1|Participant Flow|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
1071230|NCT00635817|O2|Outcome|Leuprolide Acetate 30 mg|All subjects from both treatment groups who received 30 mg leuprolide acetate, both treatment naive and previously treated, were combined.
1071231|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg|All subjects from both treatment groups who received 11.25 mg leuprolide acetate, both treatment naive and previously treated, were combined.
1071232|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
1071233|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
1071234|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
1071235|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
1071236|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
1071237|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
1071238|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
1071239|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
1071240|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
1071241|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
1071242|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
1071243|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
1071244|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
1071245|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
1071246|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
1071247|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
1071248|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
1071249|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
1071250|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
1071251|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
1071252|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
1071253|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
1071254|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
1071255|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
1071256|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
1071257|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
1071258|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
1071259|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
1071260|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
1071261|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
1071262|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
1071263|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
1071264|NCT00635817|O4|Outcome|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
1071265|NCT00635817|O3|Outcome|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
1071266|NCT00635817|O2|Outcome|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
1071267|NCT00635817|O1|Outcome|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
1071268|NCT00635817|E4|Reported Event|Leuprolide Acetate 30 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
1071269|NCT00635817|E3|Reported Event|Leuprolide Acetate 30 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
1071270|NCT00635817|E2|Reported Event|Leuprolide Acetate 11.25 mg - Previous Treatment|Subjects who received at least 1 dose of study drug.
1071271|NCT00635817|E1|Reported Event|Leuprolide Acetate 11.25 mg - Treatment Naive|Subjects who received at least 1 dose of study drug.
1071273|NCT00635804|B8|Baseline|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
1071274|NCT00635804|B7|Baseline|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
1071275|NCT00635804|B6|Baseline|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
1071276|NCT00635804|B5|Baseline|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
1071277|NCT00635804|B4|Baseline|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
1071278|NCT00635804|B3|Baseline|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
1071279|NCT00635804|B2|Baseline|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
1071280|NCT00635804|B1|Baseline|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
1071281|NCT00635804|P8|Participant Flow|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
1071282|NCT00635804|P7|Participant Flow|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
1071283|NCT00635804|P6|Participant Flow|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
1071284|NCT00635804|P5|Participant Flow|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
1071285|NCT00635804|P4|Participant Flow|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
1071286|NCT00635804|P3|Participant Flow|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
1071287|NCT00635804|P2|Participant Flow|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
1071288|NCT00635804|P1|Participant Flow|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
1071289|NCT00635804|O7|Outcome|Placebo|HCV-infected participants in Part II who received dose-matched placebo to MK-03281 orally BID for 7 consecutive days.
1071290|NCT00635804|O6|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
1071291|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panels E+F)|GT1/GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
1071292|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
1071293|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
1071294|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
1071295|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
1071296|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
1071297|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
1071298|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
1071299|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
1071300|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
1071301|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
1071302|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
1071303|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
1071304|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
1071305|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
1071306|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
1071307|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
1071308|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
1071309|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
1071310|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
1071311|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
1071312|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
1071313|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
1071314|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
1071315|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
1071316|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
1071317|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
1071318|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
1071319|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
1071320|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
1071321|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
1071441|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
1071442|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
1071322|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
1071323|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
1071324|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
1071325|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
1071326|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
1071327|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
1071328|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
1071329|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
1071330|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
1071331|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
1071332|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
1071333|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
1071334|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
1071335|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
1071336|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
1071337|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
1071338|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
1071339|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
1071340|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
1071341|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
1071342|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
1071343|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
1071344|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
1071345|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
1071443|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
1071444|NCT00635492|O1|Outcome|Insulin Cohort|insulin at a dose selected by the HCP and patient
1071346|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
1071347|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
1071348|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
1071349|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
1071350|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
1071351|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
1071352|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
1071353|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
1071354|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
1071355|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
1071356|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
1071357|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
1071358|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
1071359|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
1071360|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
1071361|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
1071362|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
1071363|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
1071364|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
1071365|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
1071366|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
1071367|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
1071368|NCT00635804|O8|Outcome|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
1071369|NCT00635804|O7|Outcome|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
1071445|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
1071446|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
1071370|NCT00635804|O6|Outcome|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
1071371|NCT00635804|O5|Outcome|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 Hepatitis C Virus (HCV)-infected male participants in this Part II serial panel received 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
1071372|NCT00635804|O4|Outcome|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
1071373|NCT00635804|O3|Outcome|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
1071374|NCT00635804|O2|Outcome|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
1071375|NCT00635804|O1|Outcome|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
1071376|NCT00635804|E8|Reported Event|Placebo|Participants receive dose-matched placebo to MK-03281 orally BID for 7 or 10 consecutive days depending on randomization. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
1071377|NCT00635804|E7|Reported Event|Pt 2: MK-3281 1200 mg BID (Panel G)|GT1a (and/or GT1 nontypeable) and GT1b HCV-infected male participants in this Part II serial panel receive 1200 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 2400 mg. The PM dose of MK-3281 was not administered on Day 7.
1071378|NCT00635804|E6|Reported Event|Pt 2: MK-3281 800 mg BID (Panel F)|GT1a/GT1-nontypeable/GT3/GT1b HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
1071379|NCT00635804|E5|Reported Event|Pt 2: MK-3281 800 mg BID (Panel E)|Genotype (GT)1 HCV-infected male participants in this Part II serial panel receive 800 mg MK-3281 orally BID for 7 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 7.
1071380|NCT00635804|E4|Reported Event|Pt 1: MK-3281 800 mg BID (Panel D)|Healthy male participants in this Part I serial panel receive 800 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 1600 mg. The PM dose of MK-3281 was not administered on Day 10.
1071381|NCT00635804|E3|Reported Event|Pt 1: MK-3281 400 mg BID (Panel C)|Healthy male participants in this Part I serial panel receive 400 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 800 mg. The PM dose of MK-3281 was not administered on Day 10.
1071382|NCT00635804|E2|Reported Event|Pt 1: MK-3281 200 mg BID (Panel B)|Healthy male participants in this Part I serial panel receive 200 mg MK-3281 orally BID for 10 consecutive days for a total daily dose administered of 400 mg. The PM dose of MK-3281 was not administered on Day 10.
1071383|NCT00635804|E1|Reported Event|Pt 1: MK-3281 100 mg BID (Panel A)|Healthy male participants in this Part I serial panel receive 100 mg MK-3281 orally twice daily (BID) for 10 consecutive days for a total daily dose administered of 200 mg. The evening (PM) dose of MK-3281 was not administered on Day 10.
1071384|NCT00635700|B3|Baseline|Total|Total of all reporting groups
1071385|NCT00635700|B2|Baseline|Placebo|placebo: placebo
1071386|NCT00635700|B1|Baseline|Ziprasidone|ziprasidone: 20-160 mg/d
1071387|NCT00635700|P2|Participant Flow|Placebo|placebo: placebo
1071388|NCT00635700|P1|Participant Flow|Ziprasidone|ziprasidone: 20-160 mg/d
1071389|NCT00635700|O2|Outcome|Placebo|placebo: placebo
1071390|NCT00635700|O1|Outcome|Ziprasidone|ziprasidone: 20-160 mg/d
1071391|NCT00635700|E2|Reported Event|Placebo|placebo: placebo
1071392|NCT00635700|E1|Reported Event|Ziprasidone|ziprasidone: 20-160 mg/d
1071393|NCT00635661|B1|Baseline|Study Participants|The study participants comprise the cohort on whom data are collected. All participants received usual rehabilitation care following admission. No experimental intervention(s) were provided.
1071394|NCT00635661|P1|Participant Flow|Study Participants|The study participants comprise the cohort on whom data are collected. All participants received usual rehabilitation care following admission. No experimental intervention(s) were provided.
1071395|NCT00635661|O1|Outcome|Study Participants|The study participants comprise the cohort on whom data are collected. All participants received usual rehabilitation care following admission. No experimental intervention(s) were provided.
1071396|NCT00635661|E1|Reported Event|Study Participants|The study participants comprise the cohort on whom data are collected. All participants received usual rehabilitation care following admission. No experimental intervention(s) were provided.
1071397|NCT00635648|B1|Baseline|Caspofungin 50 mg q.d. Intravenous (IV)|"Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days.~After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days."
1071398|NCT00635648|P1|Participant Flow|Caspofungin 50 mg q.d. Intravenous (IV)|"Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days.~After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days."
1071447|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
1071448|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
1071399|NCT00635648|O1|Outcome|Caspofungin 50 mg q.d. IV|"Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days.~After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days."
1071400|NCT00635648|O1|Outcome|Caspofungin 50 mg q.d. IV|"Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days.~After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days."
1071401|NCT00635648|O1|Outcome|Caspofungin 50 mg q.d. IV|"Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days.~After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days."
1071402|NCT00635648|O1|Outcome|Caspofungin 50 mg q.d. IV|"Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days.~After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days."
1071403|NCT00635648|E1|Reported Event|Caspofungin 50 mg q.d. IV|"Three participants with esophageal candidiasis were treated with IV caspofungin 50 mg daily (q.d.) for at least 7 days and for at least 72 hours past the resolution of symptoms for a maximum treatment duration of 28 days.~After a 70 mg loading dose on Study Day 1, 60 participants with invasive candidiasis were treated with IV caspofungin 50 mg q.d. for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum treatment duration of 60 days."
1071404|NCT00635609|B3|Baseline|Total|Total of all reporting groups
1071405|NCT00635609|B2|Baseline|Doxycycline Hyclate Immediate-release Tablets|Doxycycline hyclate immediate-release tablets, 100 mg once daily
1071406|NCT00635609|B1|Baseline|Doxycycline Hyclate (Doryx) Delayed-release Tablets|Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
1071407|NCT00635609|P2|Participant Flow|Doxycycline Hyclate Immediate-release Tablets|Doxycycline hyclate immediate-release tablets, 100 mg once daily
1071408|NCT00635609|P1|Participant Flow|Doxycycline Hyclate (Doryx) Delayed-release Tablets|Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
1071409|NCT00635609|O2|Outcome|Doxycycline Hyclate Immediate-release Tablets|Doxycycline hyclate immediate-release tablets, 100 mg once daily
1071410|NCT00635609|O1|Outcome|Doxycycline Hyclate (Doryx) Delayed-release Tablets|Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
1071411|NCT00635609|O2|Outcome|Doxycycline Hyclate Immediate-release Tablets|Doxycycline hyclate immediate-release tablets, 100 mg once daily
1071412|NCT00635609|O1|Outcome|Doxycycline Hyclate (Doryx) Delayed-release Tablets|Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
1071413|NCT00635609|O2|Outcome|Doxycycline Hyclate Immediate-release Tablets|Doxycycline hyclate immediate-release tablets, 100 mg once daily
1071414|NCT00635609|O1|Outcome|Doxycycline Hyclate (Doryx) Delayed-release Tablets|Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
1071415|NCT00635609|E2|Reported Event|Doxycycline Hyclate Immediate-release Tablets|Doxycycline hyclate immediate-release tablets, 100 mg once daily
1071416|NCT00635609|E1|Reported Event|Doxycycline Hyclate (Doryx) Delayed-release Tablets|Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily
1071417|NCT00635570|B3|Baseline|Total|Total of all reporting groups
1071418|NCT00635570|B2|Baseline|Oral Contraceptive Pill|Oral contraceptive pill (Ortho Tri-Cyclen Lo)
1071419|NCT00635570|B1|Baseline|Contraceptive Vaginal Ring|Contraceptive vaginal ring (NuvaRing)
1071420|NCT00635570|P2|Participant Flow|Oral Contraceptive Pill|Oral contraceptive pill (Ortho Tri-Cyclen Lo)
1071421|NCT00635570|P1|Participant Flow|Contraceptive Vaginal Ring|Contraceptive vaginal ring (NuvaRing)
1071422|NCT00635570|O2|Outcome|Oral Contraceptive Pill|Oral contraceptive pill (Ortho Tri-Cyclen Lo)
1071423|NCT00635570|O1|Outcome|Contraceptive Vaginal Ring|Contraceptive vaginal ring (NuvaRing)
1071424|NCT00635570|O2|Outcome|Oral Contraceptive Pill|Oral contraceptive pill (Ortho Tri-Cyclen Lo)
1071425|NCT00635570|O1|Outcome|Contraceptive Vaginal Ring|Contraceptive vaginal ring (NuvaRing)
1071426|NCT00635570|O2|Outcome|Oral Contraceptive Pill|Oral contraceptive pill (Ortho Tri-Cyclen Lo)
1071427|NCT00635570|O1|Outcome|Contraceptive Vaginal Ring|Contraceptive vaginal ring (NuvaRing)
1071428|NCT00635570|O2|Outcome|Oral Contraceptive Pill|Oral contraceptive pill (Ortho Tri-Cyclen Lo)
1071429|NCT00635570|O1|Outcome|Contraceptive Vaginal Ring|Contraceptive vaginal ring (NuvaRing)
1071430|NCT00635570|E2|Reported Event|Oral Contraceptive Pill|Oral contraceptive pill (Ortho Tri-Cyclen Lo)
1071431|NCT00635570|E1|Reported Event|Contraceptive Vaginal Ring|Contraceptive vaginal ring (NuvaRing)
1071432|NCT00635492|B3|Baseline|Total|Total of all reporting groups
1071433|NCT00635492|B2|Baseline|Insulin|Insulin at a dose selected by the HCP and patient
1071434|NCT00635492|B1|Baseline|Exenatide BID|Daily dose ranging from 5-20 ug
1071435|NCT00635492|P2|Participant Flow|Insulin|Insulin at a dose selected by the health care provided (HCP) and patient
1071436|NCT00635492|P1|Participant Flow|Exenatide BID|Daily dose ranging from 5-20 mcg
1071437|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
1071438|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
1071439|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
1071449|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
1071450|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
1071451|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
1071452|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
1071453|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
1071454|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
1071455|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
1071456|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
1071457|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
1071458|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20 mcg
1071459|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
1071460|NCT00635492|O1|Outcome|Exenatide BID|daily dose ranging from 5-20mcg/day
1071461|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
1071462|NCT00635492|O1|Outcome|Exenatide BID|daily dose ranging from 5-20mcg/day
1071463|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
1071464|NCT00635492|O1|Outcome|Exenatide BID|daily dose ranging from 5-20mcg/day
1071465|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
1071466|NCT00635492|O1|Outcome|Exenatide BID|daily dose ranging from 5-20mcg/day
1071467|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
1071468|NCT00635492|O1|Outcome|Exenatide BID|daily dose ranging from 5-20mcg/day
1071469|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
1071470|NCT00635492|O1|Outcome|Exenatide BID|daily dose ranging from 5-20mcg/day
1071471|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
1071472|NCT00635492|O1|Outcome|Exenatide BID|daily dose ranging from 5-20mcg/day
1071473|NCT00635492|O2|Outcome|Insulin|Insulin at a dose selected by the HCP and patient
1071474|NCT00635492|O1|Outcome|Exenatide BID|Daily dose ranging from 5-20mcg/day
1071475|NCT00635492|O2|Outcome|Insulin|insulin at a dose selected by the HCP and patient
1071476|NCT00635492|O1|Outcome|Exenatide BID|daily dose ranging from 5-20mcg/day
1071477|NCT00635492|E2|Reported Event|Insulin|Insulin at a dose selected by the HCP and patient
1071478|NCT00635492|E1|Reported Event|Exenatide BID|Daily dose ranging from 5-20 ug
1071479|NCT00635479|B3|Baseline|Total|Total of all reporting groups
1071480|NCT00635479|B2|Baseline|Gauze Dressing|"Gauze Dressing~Gauze dressing: Gauze dressing for surgical incision"
1071481|NCT00635479|B1|Baseline|VAC Device|"Vacuum Assisted Closure (VAC) device~Wound Vac: Vacuum Assisted Closure (VAC) device for surgical incision"
1071482|NCT00635479|P2|Participant Flow|Gauze Dressing|"Gauze Dressing~Gauze dressing: Gauze dressing for surgical incision"
1071483|NCT00635479|P1|Participant Flow|VAC Device|"Vacuum Assisted Closure (VAC) device~Wound Vac: Vacuum Assisted Closure (VAC) device for surgical incision"
1071484|NCT00635479|O2|Outcome|Gauze Dressing|"Gauze Dressing~Gauze dressing: Gauze dressing for surgical incision"
1071485|NCT00635479|O1|Outcome|VAC Device|"Vacuum Assisted Closure (VAC) device~Wound Vac: Vacuum Assisted Closure (VAC) device for surgical incision"
1071486|NCT00635479|E2|Reported Event|Gauze Dressing|"Gauze Dressing~Gauze dressing: Gauze dressing for surgical incision"
1071487|NCT00635479|E1|Reported Event|VAC Device|"Vacuum Assisted Closure (VAC) device~Wound Vac: Vacuum Assisted Closure (VAC) device for surgical incision"
1071488|NCT00635427|B6|Baseline|Total|Total of all reporting groups
1071489|NCT00635427|B5|Baseline|VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
1071490|NCT00635427|B4|Baseline|VPRIV 60 U/kg (Parent Study-imiglucerase (60 U/kg) HGT-GCB-039|Imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631) and switched 60 U/kg VPRIV in HGT-GCB-044
1071491|NCT00635427|B3|Baseline|VPRIV 60 U/kg (Parent Study VPRIV (60U/kg) HGT-GCB-039)|VPRIV 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631).
1071492|NCT00635427|B2|Baseline|VPRIV 60 U/kg (Parent Study VPRIV (60 U/kg)-TKT032)|VPRIV 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625).
1071493|NCT00635427|B1|Baseline|VPRIV 60 U/kg (Parent Study VPRIV (45 U/kg)-TKT032)|VPRIV 45 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044.
1071494|NCT00635427|P5|Participant Flow|VPRIV 15-60 U/kg (Parent Study VPRIV(15-60 U/kg)TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647) and continued in HGT-GCB-044 at the same dose as prescribed in TKT034
1071495|NCT00635427|P4|Participant Flow|VPRIV 60 U/kg (Parent Study-imiglucerase(60 U/kg)HGT-GCB-039)|imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched 60 U/kg VPRIV in HGT-GCB-044
1071496|NCT00635427|P3|Participant Flow|VPRIV 60 U/kg (Parent Study- VPRIV (60U/kg) HGT-GCB-039)|VPRIV 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)
1071497|NCT00635427|P2|Participant Flow|VPRIV 60 U/kg (Parent Study- VPRIV (60 U/kg)-TKT032)|VPRIV 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625)
1071498|NCT00635427|P1|Participant Flow|VPRIV 60 U/kg (Parent Study VPRIV (45 U/kg) -TKT032)|VPRIV 45 U/kg, IV, every other week (EOW) for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044
1071499|NCT00635427|O3|Outcome|VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
1071500|NCT00635427|O2|Outcome|VPRIV 60 U/kg (Parent Study-imiglucerase(60 U/kg) HGT-GCB-039)|imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched to 60 U/kg VPRIV in HGT-GCB-044
1071523|NCT00635362|O1|Outcome|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
1071501|NCT00635427|O1|Outcome|VPRIV 60 U/kg(VPRIV Parent Study 45 or 60 U/kg- TKT032,GCB039)|"This arm is the Overall velaglucerase alfa (VPRIV) 60 U/kg and includes participants from the following groups:~VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)"
1071502|NCT00635427|O3|Outcome|VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
1071503|NCT00635427|O2|Outcome|VPRIV 60 U/kg (Parent Study-imiglucerase(60 U/kg) HGT-GCB-039)|imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched to 60 U/kg VPRIV in HGT-GCB-044
1071504|NCT00635427|O1|Outcome|VPRIV 60 U/kg(VPRIV Parent Study 45 or 60 U/kg- TKT032,GCB039)|"This arm is the Overall velaglucerase alfa (VPRIV) 60 U/kg and includes participants from the following groups:~VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)"
1071505|NCT00635427|O3|Outcome|VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
1071506|NCT00635427|O2|Outcome|VPRIV 60 U/kg (Parent Study-imiglucerase(60 U/kg) HGT-GCB-039)|imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched to 60 U/kg VPRIV in HGT-GCB-044
1071507|NCT00635427|O1|Outcome|VPRIV 60 U/kg(VPRIV Parent Study 45 or 60 U/kg- TKT032,GCB039)|"This arm is the Overall velaglucerase alfa (VPRIV) 60 U/kg and includes participants from the following groups:~VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)"
1071508|NCT00635427|O3|Outcome|VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
1071509|NCT00635427|O2|Outcome|VPRIV 60 U/kg (Parent Study-imiglucerase(60 U/kg) HGT-GCB-039)|imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched to 60 U/kg VPRIV in HGT-GCB-044
1071510|NCT00635427|O1|Outcome|VPRIV 60 U/kg(VPRIV Parent Study 45 or 60 U/kg- TKT032,GCB039)|"This arm is the Overall velaglucerase alfa (VPRIV) 60 U/kg and includes participants from the following groups:~VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)"
1071511|NCT00635427|O3|Outcome|VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
1071512|NCT00635427|O2|Outcome|VPRIV 60 U/kg (Parent Study-imiglucerase (60 U/kg)HGT-GCB-039)|imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)and switched to 60 U/kg VPRIV in HGT-GCB-044
1071513|NCT00635427|O1|Outcome|VPRIV 60 U/kg(Parent Study VPRIV(45 or 60 U/kg) TKT032,GCB039)|"This is the overall velaglucerase alfa group consisting of the following population:~VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)"
1071514|NCT00635427|E3|Reported Event|VPRIV 60 U/kg (Parent Study-imiglucerase(60 U/kg) HGT-GCB-039)|imiglucerase 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631) and switched 60 U/kg VPRIV in HGT-GCB-044
1071515|NCT00635427|E2|Reported Event|VPRIV 60 U/kg(VPRIV Parent Study 45 or 60 U/kg- TKT032,GCB039)|"This arm is the Overall velaglucerase alfa (VPRIV) 60 U/kg and includes participants from the following groups:~VPRIV 45 U/kg or 60 U/kg, IV, EOW for 51 weeks in parent study TKT032 (NCT00430625) and switched to 60 U/kg in HGT-GCB-044 to maintain blindness or 60 U/kg, IV, EOW for 39 weeks in parent study HGT-GCB-039 (NCT00553631)"
1071516|NCT00635427|E1|Reported Event|VPRIV 15-60 U/kg (Parent Study VPRIV (15-60 U/kg) TKT034)|VPRIV 15- 60 U/kg, IV, EOW for 51 weeks in parent study TKT034 (NCT00478647). Participants continued to receive VPRIV at a dose of 15-60 U/kg throughout participation in HGT-GCB-044
1071517|NCT00635362|B3|Baseline|Total|Total of all reporting groups
1071518|NCT00635362|B2|Baseline|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
1071519|NCT00635362|B1|Baseline|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
1071520|NCT00635362|P2|Participant Flow|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
1071521|NCT00635362|P1|Participant Flow|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
1071522|NCT00635362|O2|Outcome|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
1071631|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
1071632|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
1071524|NCT00635362|O2|Outcome|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
1071525|NCT00635362|O1|Outcome|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
1071526|NCT00635362|O2|Outcome|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
1071527|NCT00635362|O1|Outcome|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
1071528|NCT00635362|O2|Outcome|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
1071529|NCT00635362|O1|Outcome|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
1071530|NCT00635362|O2|Outcome|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
1071531|NCT00635362|O1|Outcome|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
1071532|NCT00635362|E2|Reported Event|Postplacental Insertion After Cesarean|"Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta"
1071533|NCT00635362|E1|Reported Event|Delayed Insertion Group|"Insertion of the LNG-IUS 4-8 weeks after cesarean delivery~Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)~Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery"
1071534|NCT00635349|B3|Baseline|Total|Total of all reporting groups
1071535|NCT00635349|B2|Baseline|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
1071536|NCT00635349|B1|Baseline|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
1071537|NCT00635349|P2|Participant Flow|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
1071538|NCT00635349|P1|Participant Flow|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
1071539|NCT00635349|O2|Outcome|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
1071540|NCT00635349|O1|Outcome|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
1071541|NCT00635349|O2|Outcome|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
1071542|NCT00635349|O1|Outcome|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
1071543|NCT00635349|O2|Outcome|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
1071544|NCT00635349|O1|Outcome|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
1071545|NCT00635349|O2|Outcome|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
1071546|NCT00635349|O1|Outcome|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
1071547|NCT00635349|O2|Outcome|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
1071548|NCT00635349|O1|Outcome|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
1071549|NCT00635349|O2|Outcome|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
1071550|NCT00635349|O1|Outcome|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
1071551|NCT00635349|O2|Outcome|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
1071552|NCT00635349|O1|Outcome|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
1071553|NCT00635349|E2|Reported Event|Tramadol Hydrochloride Plus Acetaminophen|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets).
1071633|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
1071634|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
1071635|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
1071554|NCT00635349|E1|Reported Event|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.
1071555|NCT00635232|B6|Baseline|Total|Total of all reporting groups
1071556|NCT00635232|B5|Baseline|PS433540 800mg|PS433540 800mg once daily
1071557|NCT00635232|B4|Baseline|PS433540 400mg|PS433540 400mg once daily
1071558|NCT00635232|B3|Baseline|PS433540 200mg|PS433540 200mg once daily
1071559|NCT00635232|B2|Baseline|Placebo|Blinded Placebo Treatment
1071560|NCT00635232|B1|Baseline|Irbesartan 300mg|Irbesartan 300 mg once daily
1071561|NCT00635232|P5|Participant Flow|PS433540 800mg|PS433540 800mg once daily
1071562|NCT00635232|P4|Participant Flow|PS433540 400mg|PS433540 400mg once daily
1071563|NCT00635232|P3|Participant Flow|PS433540 200mg|PS433540 200mg once daily
1071564|NCT00635232|P2|Participant Flow|Placebo|Blinded Placebo Treatment
1071565|NCT00635232|P1|Participant Flow|Irbesartan 300mg|Irbesartan 300 mg once daily
1071566|NCT00635232|O5|Outcome|PS433540 800mg|
1071567|NCT00635232|O4|Outcome|PS433540 400mg|
1071568|NCT00635232|O3|Outcome|PS433540 200mg|
1071569|NCT00635232|O2|Outcome|Placebo|
1071570|NCT00635232|O1|Outcome|Irbesartan 300mg|
1071571|NCT00635232|O5|Outcome|PS433540 800mg|
1071572|NCT00635232|O4|Outcome|PS433540 400mg|
1071573|NCT00635232|O3|Outcome|PS433540 200mg|
1071574|NCT00635232|O2|Outcome|Placebo|
1071575|NCT00635232|O1|Outcome|Irbesartan 300mg|
1071576|NCT00635232|O5|Outcome|PS433540 800mg|
1071577|NCT00635232|O4|Outcome|PS433540 400mg|
1071578|NCT00635232|O3|Outcome|PS433540 200mg|
1071579|NCT00635232|O2|Outcome|Placebo|
1071580|NCT00635232|O1|Outcome|Irbesartan 300mg|
1071581|NCT00635232|E5|Reported Event|PS433540 800mg|PS433540 800mg once daily
1071582|NCT00635232|E4|Reported Event|PS433540 400mg|PS433540 400mg once daily
1071583|NCT00635232|E3|Reported Event|PS433540 200mg|PS433540 200mg once daily
1071584|NCT00635232|E2|Reported Event|Placebo|Blinded Placebo Treatment
1071585|NCT00635232|E1|Reported Event|Irbesartan 300mg|Irbesartan 300 mg once daily
1071586|NCT00635219|B6|Baseline|Total|Total of all reporting groups
1071587|NCT00635219|B5|Baseline|Duloxetine 60 mg|encapsulated capsules; orally
1071588|NCT00635219|B4|Baseline|Vortioxetine 10 mg|encapsulated tablets; orally
1071589|NCT00635219|B3|Baseline|Vortioxetine 5 mg|encapsulated tablets; orally
1071590|NCT00635219|B2|Baseline|Vortioxetine 2.5 mg|encapsulated tablets; orally
1071591|NCT00635219|B1|Baseline|Placebo|capsules; daily; orally
1071592|NCT00635219|P5|Participant Flow|Duloxetine 60 mg|encapsulated capsules; orally
1071593|NCT00635219|P4|Participant Flow|Vortioxetine 10 mg|encapsulated tablets; orally
1071594|NCT00635219|P3|Participant Flow|Vortioxetine 5 mg|encapsulated tablets; orally
1071595|NCT00635219|P2|Participant Flow|Vortioxetine 2.5 mg|encapsulated tablets; orally
1071596|NCT00635219|P1|Participant Flow|Placebo|capsules; daily; orally
1071597|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
1071598|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
1071599|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
1071600|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
1071601|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
1071602|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
1071603|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
1071604|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
1071605|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
1071606|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
1071607|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
1071608|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
1071609|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
1071610|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
1071611|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
1071612|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
1071613|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
1071614|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
1071615|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
1071616|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
1071617|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
1071618|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
1071619|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
1071620|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
1071621|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
1071622|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
1071623|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
1071624|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
1071625|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
1071626|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
1071627|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
1071628|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
1071629|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
1071630|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
1071637|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
1071638|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
1071639|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
1071640|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
1071641|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
1071642|NCT00635219|O5|Outcome|Duloxetine 60 mg|encapsulated capsules; orally
1071643|NCT00635219|O4|Outcome|Vortioxetine 10 mg|encapsulated tablets; orally
1071644|NCT00635219|O3|Outcome|Vortioxetine 5 mg|encapsulated tablets; orally
1071645|NCT00635219|O2|Outcome|Vortioxetine 2.5 mg|encapsulated tablets; orally
1071646|NCT00635219|O1|Outcome|Placebo|capsules; daily; orally
1071647|NCT00635219|E5|Reported Event|Duloxetine 60 mg|
1071648|NCT00635219|E4|Reported Event|Vortioxetine 10 mg|
1071649|NCT00635219|E3|Reported Event|Vortioxetine 5 mg|
1071650|NCT00635219|E2|Reported Event|Vortioxetine 2.5 mg|
1071651|NCT00635219|E1|Reported Event|Placebo|
1071652|NCT00635154|B1|Baseline|Anakinra With/Without Dexamethasone|
1071653|NCT00635154|P1|Participant Flow|Anakinra With/Without Dexamethasone|
1071654|NCT00635154|O1|Outcome|Anakinra With/Without Dexamethasone|
1071655|NCT00635154|O1|Outcome|Anakinra With Dexamethasone|Patients in this outcome received both Anakinra (100mg daily subcutaneously administered) and dexamethasone (either 20mg/week OR 40mg days 1-4, 9-12, 17-20 every 28 days during odd cycles OR 40 mg days 1-4 every 28 days during even cycles)
1071656|NCT00635154|O1|Outcome|Anakinra With/Without Dexamethasone|
1071657|NCT00635154|O1|Outcome|Anakinra With/Without Dexamethasone|
1071658|NCT00635154|O1|Outcome|Anakinra With/Without Dexamethasone|
1071659|NCT00635154|O1|Outcome|Anakinra With Dexamethasone|Patients in this outcome received both Anakinra (100mg daily subcutaneously administered) and dexamethasone (either 20mg/week OR 40mg days 1-4, 9-12, 17-20 every 28 days during odd cycles OR 40 mg days 1-4 every 28 days during even cycles)
1071660|NCT00635154|O1|Outcome|Anakinra Without Dexamethasone|Patients in this outcome received only Anakinra (100mg daily subcutaneously administered).
1071661|NCT00635154|E1|Reported Event|Anakinra With/Without Dexamethasone|
1071662|NCT00635102|B3|Baseline|Total|Total of all reporting groups
1071663|NCT00635102|B2|Baseline|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071664|NCT00635102|B1|Baseline|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071665|NCT00635102|P2|Participant Flow|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the structured clinical interview (SCID).
1071666|NCT00635102|P1|Participant Flow|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet Diagnostic and Statistical manual (DSM) IV criteria for alcohol dependence by structured clinical interview
1071667|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071668|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071669|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071670|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071671|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071672|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071673|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071674|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071675|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071676|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071677|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071678|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071679|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071680|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071681|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071682|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071683|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071684|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071685|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071686|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071687|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071688|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071689|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071690|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071691|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071692|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071693|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071694|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071695|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071696|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1072334|NCT00633932|O3|Outcome|Comparator: Omeprazole 20mg|Omeprazole 20mg once daily
1071697|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071698|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071699|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071700|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071701|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071702|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071703|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071704|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071705|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071706|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071707|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071708|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071709|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071710|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071711|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071712|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071713|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071714|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071715|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071716|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071717|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1072335|NCT00633932|O2|Outcome|Experimental: Esomeprazole 20mg|Esomeprazole 20mg once daily
1071718|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071719|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071720|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071721|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071722|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071723|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071724|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071725|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071726|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071727|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071728|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071729|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071730|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071731|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071732|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071733|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071734|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071735|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071736|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071737|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071738|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1072336|NCT00633932|O1|Outcome|Experimental: Esomeprazole 40mg|Esomeprazole 40mg once daily
1071739|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071740|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071741|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071742|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071743|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071744|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071745|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071746|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071747|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071748|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071749|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071750|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071751|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071752|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071753|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071754|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071755|NCT00635102|O2|Outcome|Healthy Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID.
1071756|NCT00635102|O1|Outcome|Alcoholic Subjects|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview
1071757|NCT00635102|E2|Reported Event|Healthy Subjects|
1071758|NCT00635102|E1|Reported Event|Alcoholic Subjects|
1071759|NCT00635089|B1|Baseline|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
1071760|NCT00635089|P1|Participant Flow|Open-Label Reslizumab|Open-label reslizumab intravenous (IV) infusion at an initial dose of 1 mg/kg monthly
1071761|NCT00635089|O1|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
1071762|NCT00635089|O4|Outcome|Open-Label Reslizumab: Overall|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly, continued at 1 to 3 mg/kg monthly
1071763|NCT00635089|O3|Outcome|Open-Label Reslizumab: 3 mg/kg|Open-label reslizumab IV infusion at 3 mg/kg monthly
1071764|NCT00635089|O2|Outcome|Open-Label Reslizumab: 2 mg/kg|Open-label reslizumab IV infusion at 2 mg/kg monthly
1071765|NCT00635089|O1|Outcome|Open-Label Reslizumab: 1 mg/kg|Open-label reslizumab IV infusion at 1 mg/kg monthly
1071766|NCT00635089|O4|Outcome|Changed by Eating Foods That Previously Worsened EoE|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly who changed their diet from the beginning of the double-blind study (NCT00538434) by eating foods that previously worsened EoE.
1071767|NCT00635089|O3|Outcome|Changed by Increasing Consistency of Food|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly who changed their diet from the beginning of the double-blind study (NCT00538434) by increasing the consistency of their food.
1071768|NCT00635089|O2|Outcome|Changed Diet From Beginning of Double-blind Study|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly who changed their diet from the beginning of the double-blind study (NCT00538434).
1071769|NCT00635089|O1|Outcome|Maintained Diet From Beginning of Double-blind Study|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly who maintained their diet from the beginning of the double-blind study (NCT00538434).
1071770|NCT00635089|O1|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
1071771|NCT00635089|O1|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
1071772|NCT00635089|O1|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
1071773|NCT00635089|O1|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
1071774|NCT00635089|O5|Outcome|Grade 4|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly with an infusion site evaluation grade 4.
1071775|NCT00635089|O4|Outcome|Grade 3|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly with an infusion site evaluation grade 3.
1071776|NCT00635089|O3|Outcome|Grade 2|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly with an infusion site evaluation grade 2.
1071777|NCT00635089|O2|Outcome|Grade 1|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly with an infusion site evaluation grade 1.
1071778|NCT00635089|O1|Outcome|Grade 0|Participants receiving open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly with an infusion site evaluation grade 0.
1071779|NCT00635089|O1|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
1071780|NCT00635089|O1|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
1071781|NCT00635089|O1|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
1071782|NCT00635089|O1|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
1071783|NCT00635089|O1|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
1071784|NCT00635089|O1|Outcome|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
1071785|NCT00635089|E1|Reported Event|Open-Label Reslizumab|Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly
1071786|NCT00635050|B1|Baseline|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two stage phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with locally advanced invasive breast cancer.~Regimen A: Sequential Doxil 25 mg/m2 every 2 weeks for 3 doses, then paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then cyclophosphamide 600 mg/M 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 weeks will be given concurrently with all 3 agents. Patients who experience <pCR to chemotherapy will receive an additional year of Avastin at the same dose equivalent starting 6-8 weeks after operation.~Regimen B: Identical to Regimen A except that the dose of Doxil will be 30 mg/m2."
1071787|NCT00635050|P1|Participant Flow|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two stage phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with locally advanced invasive breast cancer.~Doxil, Paclitaxel, Cyclophosphamide, Avastin: Regimen A: Sequential Doxil 25 mg/m2 every 2 weeks for 3 doses, followed by paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then cyclophosphamide 600 mg/M 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 weeks will be given concurrently with all 3 agents. Patients who experience <pCR to primary chemotherapy will receive an additional year of Avastin at the same dose equivalent beginning 6-8 weeks after definitive operation.~Regimen B: Sequential Doxil 30 mg/m2 every 2 weeks for 3 doses will be followed by paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then by cyclophosphamide 600 mg/m 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 week"
1071788|NCT00635050|O1|Outcome|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two stage phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with locally advanced invasive breast cancer.~Regimen A: Sequential Doxil 25 mg/m2 every 2 weeks for 3 doses, then paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then cyclophosphamide 600 mg/M 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 weeks will be given concurrently with all 3 agents. Patients who experience <pCR to chemotherapy will receive an additional year of Avastin at the same dose equivalent starting 6-8 weeks after operation.~Regimen B: Identical to Regimen A except that the dose of Doxil will be 30 mg/m2."
1071789|NCT00635050|O1|Outcome|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two stage phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with locally advanced invasive breast cancer.~Doxil, Paclitaxel, Cyclophosphamide, Avastin:~Regimen A: Doxil 25 mg/M2 iv and Avastin 10 mg/kg iv every 2 weeks x 3, then paclitaxel 175 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3, then cyclophosphamide 600 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3 . Patients who experience <pCR to primary chemotherapy will receive an additional year of Avastin 15 mg/kg iv every 3 weeks, beginning 6-8 weeks after operation.~Regimen B: Identical to Regimen A except that the Doxil dose was 30 mg/M2 iv every 2 weeks x 3."
1072086|NCT00634322|O2|Outcome|High-dose Methotrexate Plus Placebo Then Glucarpidase|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart
1072337|NCT00633932|E3|Reported Event|Comparator: Omeprazole 20mg|Omeprazole 20mg once daily
1071790|NCT00635050|O1|Outcome|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two staged phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with advanced invasive breast cancer.~Regimen A: Doxil 25 mg/M2 iv and Avastin 10 mg/kg iv every 2 weeks x 3, then paclitaxel 175 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3, then cyclophosphamide 600 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3 . Patients who experience <pCR to primary chemotherapy will receive an additional year of Avastin 15 mg/kg iv every 3 weeks, beginning 6-8 weeks after operation.~Regimen B: Identical to Regimen A except that the Doxil dose was 30 mg/M2 iv every 2 weeks x 3."
1071791|NCT00635050|O1|Outcome|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two stage phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with advanced invasive breast cancer.~Regimen A: Doxil 25 mg/M2 iv and Avastin 10 mg/kg iv every 2 weeks x 3, then paclitaxel 175 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3, then cyclophosphamide 600 mg/M2 i.v. and Avastin 10 mg/kg iv every 2 weeks x 3 . Patients who experience <pCR to primary chemotherapy will receive an additional year of Avastin 15 mg/kg iv every 3 weeks, beginning 6-8 weeks after operation.~Regimen B: Identical to Regimen A except that the Doxil dose was 30 mg/M2 iv every 2 weeks x 3."
1071792|NCT00635050|E1|Reported Event|Doxil, Paclitaxel, Cyclophosphamide + Avastin|"Two staged phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with advanced invasive breast cancer.~Doxil, Paclitaxel, Cyclophosphamide, Avastin: Regimen A: Sequential Doxil 25 mg/m2 every 2 weeks for 3 doses will be followed by paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then by cyclophosphamide 600 mg/M 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 weeks will be given concurrently with all 3 agents. Patients who experience <pCR to primary chemotherapy will receive an additional year of Avastin at the same dose equivalent beginning 6-8 weeks after definitive operation.~Regimen B: Sequential Doxil 30 mg/m2 every 2 weeks for 3 doses will be followed by paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then by cyclophosphamide 600 mg/m 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 week"
1071793|NCT00635024|B1|Baseline|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
1071794|NCT00635024|P1|Participant Flow|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
1071795|NCT00635024|O1|Outcome|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
1071796|NCT00635024|O1|Outcome|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
1071797|NCT00635024|O1|Outcome|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
1071798|NCT00635024|O1|Outcome|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
1071799|NCT00635024|O1|Outcome|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
1071800|NCT00635024|E1|Reported Event|Anti-thymocyte Globulin/Melphalan|Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m^2)
1071801|NCT00634933|B4|Baseline|Total|Total of all reporting groups
1071802|NCT00634933|B3|Baseline|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071803|NCT00634933|B2|Baseline|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071804|NCT00634933|B1|Baseline|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071805|NCT00634933|P5|Participant Flow|Placebo/TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24 and 36.
1071806|NCT00634933|P4|Participant Flow|Placebo/TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1072126|NCT00634244|O2|Outcome|Arm B (Alvocidib+Cytarabine+Mitoxantrone)|Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.
1071807|NCT00634933|P3|Participant Flow|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071808|NCT00634933|P2|Participant Flow|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 800 mg, IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 800 mg infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071809|NCT00634933|P1|Participant Flow|Placebo|Placebo infusion, matched to TRU-015 (800 milligram [mg]), intravenously (IV) along with methylprednisolone 100 mg IV 1 hour (hr) prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. Participants in this group were assigned to either Placebo/TRU-SD or Placebo/TRU-ID in the Part B of the study.
1071810|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071811|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071812|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071813|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071814|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071875|NCT00634920|B3|Baseline|Not Randomized Patients|This group included patients in whom a renal TX was performed but who did not qualify for randomization at Visit 2. This group was to be described with respect to treatment, reason for not randomized and outcome variables calculated or measured GFR, whichever was feasible, BPAR, graft loss or death at 12 months (no outcome variables were collected for this population
1072127|NCT00634244|O1|Outcome|Arm A (Carboplatin+Topotecan Hydrochloride)|Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.
1071815|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071816|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071817|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071818|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071819|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071820|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071821|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071822|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071974|NCT00634582|B1|Baseline|Paricalcitol|Paricalcitol capsules (Zemplar, Abbott) will be given on day 1 at 1 micrograms by mouth and continue daily for 16 weeks if all conditions for continuation are met
1072338|NCT00633932|E2|Reported Event|Experimental: Esomeprazole 20mg|Esomeprazole 20mg once daily
1071823|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071824|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071825|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071826|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071827|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071828|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071829|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071830|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071975|NCT00634582|P1|Participant Flow|Paricalcitol|Paricalcitol capsules (Zemplar, Abbott) will be given on day 1 at 1 micrograms by mouth and continue daily for 16 weeks if all conditions for continuation are met
1072339|NCT00633932|E1|Reported Event|Experimental: Esomeprazole 40mg|Esomeprazole 40mg once daily
1071831|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071832|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071833|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071834|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071835|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071836|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071837|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071838|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071976|NCT00634582|O1|Outcome|Paricalcitol|Paricalcitol capsules (Zemplar, Abbott) will be given on day 1 at 1 micrograms by mouth and continue daily for 16 weeks if all conditions for continuation are met
1071977|NCT00634582|E1|Reported Event|Paricalcitol|Paricalcitol capsules (Zemplar, Abbott) will be given on day 1 at 1 micrograms by mouth and continue daily for 16 weeks if all conditions for continuation are met
1071839|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071840|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071841|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071842|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071843|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071844|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071845|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071846|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071978|NCT00634569|B3|Baseline|Total|Total of all reporting groups
1071979|NCT00634569|B2|Baseline|28-day Dosing|IGIV given every 28-days (300-800 mg/kg)
1071980|NCT00634569|B1|Baseline|21-day Dosing|IGIV given every 21-days (225-600 mg/kg)
1071981|NCT00634569|P2|Participant Flow|28-day Dosing|IGIV given every 28-days (300-800 mg/kg)
1071847|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071848|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071849|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071850|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071851|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071852|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071853|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071854|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071982|NCT00634569|P1|Participant Flow|21-day Dosing|IGIV given every 21-days (225-600 mg/kg)
1071983|NCT00634569|O1|Outcome|All Subjects|Intent-to-treat population
1071984|NCT00634569|O1|Outcome|All Subjects|Intent-to-treat population
1071855|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071856|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071857|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071858|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071859|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071860|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071861|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071862|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071985|NCT00634569|O1|Outcome|All Subjects|Intent-to-treat population
1071986|NCT00634569|O1|Outcome|All Subjects|Intent-to-treat population
1071987|NCT00634569|O1|Outcome|All Subjects|Intent-to-treat population
1071988|NCT00634569|O1|Outcome|All Subjects|Intent-to-treat population
1071863|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071864|NCT00634933|O3|Outcome|TRU-015 Induction Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071865|NCT00634933|O2|Outcome|TRU-015 Single Dose|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071866|NCT00634933|O1|Outcome|Placebo|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion or matching placebo IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071867|NCT00634933|E7|Reported Event|Placebo/TRU-015 Induction Dose (Part B)|TRU-015 800 mg infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24 and 36.
1071868|NCT00634933|E6|Reported Event|Placebo/TRU-015 Single Dose (Part B)|TRU-015 800 mg infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 800 mg, IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071869|NCT00634933|E5|Reported Event|TRU-015 Induction Dose (Part B)|Placebo infusion, matched to TRU-015 (800 mg), IV, placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo capsule matched to prednisone 20 mg orally each day for 2 days prior to and on the morning of infusion at Week 24. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071870|NCT00634933|E4|Reported Event|TRU-015 Single Dose (Part B)|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 24. Placebo infusion, matched to TRU-015 (800 mg) IV along with placebo matched to methylprednisolone 100 mg IV 1 hr prior to infusion and placebo matched to prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at Week 36.
1071871|NCT00634933|E3|Reported Event|TRU-015 Induction Dose (Part A)|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Participants in this group were assigned to TRU-ID in the Part B of the study.
1071872|NCT00634933|E2|Reported Event|TRU-015 Single Dose (Part A)|TRU-015 (800 mg) infusion IV, methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV, methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of infusion at Week 12. Participants in this group were assigned to TRU-SD in the Part B of the study.
1071873|NCT00634933|E1|Reported Event|Placebo (Part A)|Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg IV 1 hr prior to infusion and prednisone 20 mg capsule orally each day for 2 days prior to and on the morning of infusion at baseline. Placebo infusion, matched to TRU-015 (800 mg), IV along with methylprednisolone 100 mg or matching placebo IV 1 hr prior to infusion and prednisone 20 mg capsule or matching placebo orally each day for 2 days prior to and on the morning of the infusion at Week 12. Participants in this group were assigned to either Placebo/TRU-SD or Placebo/TRU-ID in the Part B of the study.
1071874|NCT00634920|B4|Baseline|Total|Total of all reporting groups
1071989|NCT00634569|O1|Outcome|All Subjects|Intent-to-treat population
1071990|NCT00634569|O2|Outcome|28-day Dosing|IGIV given every 28-days (300-800 mg/kg)
1071991|NCT00634569|O1|Outcome|21-day Dosing|IGIV given every 21-days (225-600 mg/kg)
1071876|NCT00634920|B2|Baseline|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
1071877|NCT00634920|B1|Baseline|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
1071878|NCT00634920|P3|Participant Flow|Pre-Randomized Patients|All patients received induction therapy with 20 mg basiliximab on Day 0 prior to reperfusion and 20 mg at Day 4 post-TX (transplatation), and commenced on an immunosuppressive regimen consisting of: CsA (based on trough levels C0-h 100-250 ng/mL or C2-h 900 1300 ng/mL, according to local method), EC MPS (target dose 1440 mg/day, minimum dose 1080 mg/day at the time of randomization), Corticosteroids (a minimum dose of 10 mg prednisolone or equivalent was given at time of randomization).
1071879|NCT00634920|P2|Participant Flow|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
1071880|NCT00634920|P1|Participant Flow|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
1071881|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
1071882|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
1071883|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
1071884|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
1071885|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
1071886|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
1071887|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
1071888|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
1071889|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
1071992|NCT00634569|E1|Reported Event|All Subjects|Intent-to-treat population
1071993|NCT00634543|B3|Baseline|Total|Total of all reporting groups
1072340|NCT00633919|B3|Baseline|Total|Total of all reporting groups
1071890|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
1071891|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
1071892|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
1071893|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
1071894|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
1071895|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
1071896|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
1071897|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
1071898|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
1071899|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
1071900|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
1071901|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
1071902|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
1071903|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
1072087|NCT00634322|O1|Outcome|High-dose Methotrexate Plus Glucarpidase Then Placebo|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart
1071904|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
1071905|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
1071906|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
1071907|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
1071908|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
1071909|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
1071910|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
1071911|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
1071912|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
1071913|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
1071914|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
1071915|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
1071916|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
1071917|NCT00634920|O2|Outcome|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
1072088|NCT00634322|E3|Reported Event|Arm C, Compassionate Use of Glucarpidase|Compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment. Patients received glucarpidase 50 U/kg
1071918|NCT00634920|O1|Outcome|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
1071919|NCT00634920|E2|Reported Event|Everolimus (CNI-free)|This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus.
1071920|NCT00634920|E1|Reported Event|Control (CsA)|All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period.
1071921|NCT00634907|B3|Baseline|Total|Total of all reporting groups
1071922|NCT00634907|B2|Baseline|Control Arm|Standard of care dosing
1071923|NCT00634907|B1|Baseline|Genotype-Based Dosing Arm|Initial warfarin dose calculated according to published Sconce algorithm
1071924|NCT00634907|P2|Participant Flow|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
1071925|NCT00634907|P1|Participant Flow|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:~Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
1071926|NCT00634907|O2|Outcome|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
1071927|NCT00634907|O1|Outcome|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:~Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
1071928|NCT00634907|O2|Outcome|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
1071929|NCT00634907|O1|Outcome|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:~Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
1071930|NCT00634907|O2|Outcome|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
1071994|NCT00634543|B2|Baseline|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
1072341|NCT00633919|B2|Baseline|Placebo|SLITone Placebo
1071931|NCT00634907|O1|Outcome|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:~Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
1071932|NCT00634907|O2|Outcome|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
1071933|NCT00634907|O1|Outcome|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:~Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
1071934|NCT00634907|O2|Outcome|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
1071935|NCT00634907|O1|Outcome|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:~Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
1071936|NCT00634907|O2|Outcome|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
1071937|NCT00634907|O1|Outcome|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:~Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
1071938|NCT00634907|O2|Outcome|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
1071939|NCT00634907|O1|Outcome|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:~Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
1071940|NCT00634907|O2|Outcome|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
1072342|NCT00633919|B1|Baseline|Active|SLITone Dermatophagoides Mix
1072343|NCT00633919|P2|Participant Flow|Placebo|SLITone Placebo
1072344|NCT00633919|P1|Participant Flow|Active|SLITone Dermatophagoides Mix
1071941|NCT00634907|O1|Outcome|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:~Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
1071942|NCT00634907|O2|Outcome|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
1071943|NCT00634907|O1|Outcome|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:~Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
1071944|NCT00634907|E2|Reported Event|1 Control Arm|This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
1071945|NCT00634907|E1|Reported Event|2 Genotype Arm|"The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:~Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter."
1071946|NCT00634842|B3|Baseline|Total|Total of all reporting groups
1071947|NCT00634842|B2|Baseline|FPG 80-110 mg/dL|Conventional FPG (fasting plasma glucose) titration target range group
1071948|NCT00634842|B1|Baseline|FPG 70-90 mg/dL|Aggressive FPG (fasting plasma glucose) titration target range group
1071949|NCT00634842|P2|Participant Flow|FPG 80-110 mg/dL|Conventional FPG (fasting plasma glucose) titration target range group
1071950|NCT00634842|P1|Participant Flow|FPG 70-90 mg/dL|Aggressive FPG (fasting plasma glucose) titration target range group
1071951|NCT00634842|O2|Outcome|FPG 80-110 mg/dL|Conventional FPG (fasting plasma glucose) titration target range group
1071952|NCT00634842|O1|Outcome|FPG 70-90 mg/dL|Aggressive FPG (fasting plasma glucose) titration target range group
1071953|NCT00634842|O2|Outcome|FPG 80-110 mg/dL|Conventional FPG (fasting plasma glucose) titration target range group
1071954|NCT00634842|O1|Outcome|FPG 70-90 mg/dL|Aggressive FPG (fasting plasma glucose) titration target range group
1071955|NCT00634842|O2|Outcome|FPG 80-110 mg/dL|Conventional FPG (fasting plasma glucose) titration target range group
1071956|NCT00634842|O1|Outcome|FPG 70-90 mg/dL|Aggressive FPG (fasting plasma glucose) titration target range group
1071957|NCT00634842|O2|Outcome|FPG 80-110 mg/dL|Conventional FPG (fasting plasma glucose) titration target range group
1071958|NCT00634842|O1|Outcome|FPG 70-90 mg/dL|Aggressive FPG (fasting plasma glucose) titration target range group
1071959|NCT00634842|E2|Reported Event|FPG 80-110 mg/dL|Conventional FPG (fasting plasma glucose) titration target range group
1071960|NCT00634842|E1|Reported Event|FPG 70-90 mg/dL|Aggressive FPG (fasting plasma glucose) titration target range group
1071961|NCT00634647|B1|Baseline|Satraplatin|satraplatin - 80 mg/m^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
1071962|NCT00634647|P1|Participant Flow|Satraplatin|satraplatin - 80 mg/m^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
1071963|NCT00634647|O1|Outcome|Satraplatin|satraplatin - 80 mg/m^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
1071964|NCT00634647|O1|Outcome|Satraplatin|satraplatin - 80 mg/m^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
1071965|NCT00634647|E1|Reported Event|Satraplatin|satraplatin - 80 mg/m^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
1071966|NCT00634621|B1|Baseline|Hexvix|Use of the Hexvix drug.
1071967|NCT00634621|P1|Participant Flow|Hexvix 2 mg/mL Infusion|Administrtation of 2 mg/mL Hexvix.
1071968|NCT00634621|O1|Outcome|Confirmed Bladder Cancer by Standard of Truth|Using the Hexvix drug with a cystoscopy technique of White-light cystoscopy and Blue-light cystoscopy.
1071969|NCT00634621|O4|Outcome|Multiple Normalized Biopsy|Only Multiple Normalized Biopsy.
1071970|NCT00634621|O3|Outcome|Blue-light Cystoscopy Only|Hexvix administered using only Blue-light Cystoscopy.
1071971|NCT00634621|O2|Outcome|White-light Cystoscopy Only|Hexvix administered using only White-light Cystoscopy.
1071972|NCT00634621|O1|Outcome|White-light and Blue-Light Cystoscopy Simultaneously|Hexvix administered using both White-light and Blue-Light Cystoscopy.
1071973|NCT00634621|E1|Reported Event|Hexvix|Use of the Hexvix drug.
1071995|NCT00634543|B1|Baseline|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
1071996|NCT00634543|P2|Participant Flow|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
1071997|NCT00634543|P1|Participant Flow|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
1071998|NCT00634543|O2|Outcome|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
1071999|NCT00634543|O1|Outcome|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
1072000|NCT00634543|O2|Outcome|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
1072001|NCT00634543|O1|Outcome|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
1072002|NCT00634543|O2|Outcome|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
1072003|NCT00634543|O1|Outcome|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
1072004|NCT00634543|O2|Outcome|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
1072005|NCT00634543|O1|Outcome|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
1072006|NCT00634543|O2|Outcome|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
1072007|NCT00634543|O1|Outcome|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
1072008|NCT00634543|O2|Outcome|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
1072009|NCT00634543|O1|Outcome|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
1072010|NCT00634543|E2|Reported Event|Gabapentin|Participants received gabapentin 300 mg once daily at bed time on Day 1, 300 mg twice daily on Day 2 and 300 mg thrice daily on Day 3. Gabapentin 300 mg was administered twice daily (in the morning and midday) and gabapentin 600 mg in the evening on Day 8 to 14. If there was no pain relief, the dosage were increased up to 3600 mg per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
1072085|NCT00634322|O3|Outcome|Arm C, Compassionate Use of Glucarpidase|Compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment. Patients received glucarpidase 50 U/kg
1072345|NCT00633919|O2|Outcome|Placebo|SLITone Placebo
1072011|NCT00634543|E1|Reported Event|Tramadol Hydrochloride/ Acetaminophen|Participants received 1 tablet containing tramadol hydrochloride (HCl) 37.5 milligram (mg) and acetaminophen 325 mg, once daily, at bed time on Day 1 to 3, 1 tablet twice daily on Day 4 to 7 and 1 tablet thrice daily on Day 8 to 14. If there was no pain relief, the dosage were increased up to 8 tablets per day for Day 15 to 28. The increased dose was maintained for Day 29 to 42.
1072012|NCT00634504|B3|Baseline|Total|Total of all reporting groups
1072013|NCT00634504|B2|Baseline|B (High-dose Methotrexate and Leucovorin Without Glucarpidase)|"High-dose methotrexate and leucovorin without glucarpidase~high-dose methotrexate, leucovorin: standard of care, leucovorin every 6 hours"
1072014|NCT00634504|B1|Baseline|A (High-dose Methotrexate, Leucovorin, and Glucarpidase)|"High-dose methotrexate, leucovorin, and glucarpidase~glucarpidase, high-dose methotrexate, leucovorin: single intravenous dose"
1072015|NCT00634504|P2|Participant Flow|B (High-dose Methotrexate and Leucovorin Without Glucarpidase)|"High-dose methotrexate and leucovorin without glucarpidase~high-dose methotrexate, leucovorin: standard of care, leucovorin every 6 hours"
1072016|NCT00634504|P1|Participant Flow|A (High-dose Methotrexate, Leucovorin, and Glucarpidase)|"High-dose methotrexate, leucovorin, and glucarpidase~glucarpidase, high-dose methotrexate, leucovorin: single intravenous dose"
1072017|NCT00634504|O2|Outcome|B (High-dose Methotrexate and Leucovorin Without Glucarpidase)|"High-dose methotrexate and leucovorin without glucarpidase~high-dose methotrexate, leucovorin: standard of care, leucovorin every 6 hours"
1072018|NCT00634504|O1|Outcome|A (High-dose Methotrexate, Leucovorin, and Glucarpidase)|"High-dose methotrexate, leucovorin, and glucarpidase~glucarpidase, high-dose methotrexate, leucovorin: single intravenous dose"
1072019|NCT00634504|E2|Reported Event|B (High-dose Methotrexate and Leucovorin Without Glucarpidase)|"High-dose methotrexate and leucovorin without glucarpidase~high-dose methotrexate, leucovorin: standard of care, leucovorin every 6 hours"
1072020|NCT00634504|E1|Reported Event|A (High-dose Methotrexate, Leucovorin, and Glucarpidase)|"High-dose methotrexate, leucovorin, and glucarpidase~glucarpidase, high-dose methotrexate, leucovorin: single intravenous dose"
1072021|NCT00633360|B3|Baseline|Total|Total of all reporting groups
1072022|NCT00633360|B2|Baseline|Placebo|"Placebo~Placebo: Once daily by mouth"
1072023|NCT00633360|B1|Baseline|Drospirenone and Ethinyl Estradiol|"Drospirenone and ethinyl estradiol~Drospirenone and ethinyl estradiol: Once daily by mouth"
1072024|NCT00633360|P2|Participant Flow|Placebo|"Placebo~Placebo: Once daily by mouth"
1072025|NCT00633360|P1|Participant Flow|Drospirenone and Ethinyl Estradiol|"Drospirenone and ethinyl estradiol~Drospirenone and ethinyl estradiol: Once daily by mouth"
1072026|NCT00633360|O2|Outcome|Placebo|Placebo
1072027|NCT00633360|O1|Outcome|Drospirenone and Ethinyl Estradiol|Drospirenone and ethinyl estradiol
1072028|NCT00633360|O2|Outcome|Placebo|"Placebo~Placebo: Once daily by mouth"
1072029|NCT00633360|O1|Outcome|Drospirenone and Ethinyl Estradiol|"Drospirenone and ethinyl estradiol~Drospirenone and ethinyl estradiol: Once daily by mouth"
1072030|NCT00633360|E2|Reported Event|Placebo|"Placebo~Placebo: Once daily by mouth"
1072031|NCT00633360|E1|Reported Event|Drospirenone and Ethinyl Estradiol|"Drospirenone and ethinyl estradiol~Drospirenone and ethinyl estradiol: Once daily by mouth"
1072032|NCT00633256|B3|Baseline|Total|Total of all reporting groups
1072033|NCT00633256|B2|Baseline|Placebo|Matched placebo
1072034|NCT00633256|B1|Baseline|Cycloserine|50 mg cycloserine
1072035|NCT00633256|P2|Participant Flow|Placebo|Matched placebo
1072036|NCT00633256|P1|Participant Flow|Cycloserine|50 mg cycloserine
1072037|NCT00633256|O2|Outcome|Placebo|Matched placebo
1072038|NCT00633256|O1|Outcome|Cycloserine|50 mg cycloserine
1072039|NCT00633256|O2|Outcome|Placebo|Matched placebo
1072040|NCT00633256|O1|Outcome|Cycloserine|50 mg cycloserine
1072041|NCT00633256|O2|Outcome|Placebo|Matched placebo
1072042|NCT00633256|O1|Outcome|Cycloserine|50 mg cycloserine
1072043|NCT00633256|E2|Reported Event|Placebo|Matched placebo
1072044|NCT00633256|E1|Reported Event|Cycloserine|50 mg cycloserine
1072045|NCT00633243|B3|Baseline|Total|Total of all reporting groups
1072046|NCT00633243|B2|Baseline|Self-Administered Therapy (SAT)|Subjects received their methadone remote from their site of HCV treatment. HCV treatment was provided within the Yale Liver Center, the university-based liver specialty clinic. All subjects in this arm were taught how to self-administer therapy (SAT), the PEG and RBV. Subjects followed a pre-specified time period of attending the Liver Center for clinical follow-up and blood work.
1072047|NCT00633243|B1|Baseline|Modified Directly Observed Therapy (mDOT)|Subjects received modified directly observed therapy (mDOT) as part of an adherence intervention. Clinical nurses administered all methadone doses and co-administered the morning RBV dose. The evening dose of RBV was prepackaged by a pharmacist accessible for the subject to self-administer 12 hours later. PEG was administered to mDOT subjects weekly by a licensed practitioners. All mDOT subjects who earned take-home bottles for methadone also received take-home doses of RBV.
1072048|NCT00633243|P2|Participant Flow|Self-Administered Therapy (SAT)|Subjects received their methadone remote from their site of HCV treatment. HCV treatment was provided within the Yale Liver Center, the university-based liver specialty clinic. All subjects in this arm were taught how to self-administer therapy (SAT), the pegylated interferon alfa-a (PEG) and weight-based ribavirin (RBV). Subjects followed a pre-specified time period of attending the Liver Center for clinical follow-up and blood work.
1072049|NCT00633243|P1|Participant Flow|Modified Directly Observed Therapy (mDOT)|Subjects received modified directly observed therapy (mDOT) as part of an adherence intervention. Clinical nurses administered all methadone doses and co-administered the morning weight-based ribavirin (RBV) dose. The evening dose of RBV was prepackaged by a pharmacist accessible for the subject to self-administer 12 hours later. Pegylated interferon alfa-2a(PEG) was administered to mDOT subjects weekly by a licensed practitioners. All mDOT subjects who earned take-home bottles for methadone also received take-home doses of RBV.
1072050|NCT00633243|O2|Outcome|Self-Administered Therapy (SAT)|Subjects received their methadone remote from their site of HCV treatment. HCV treatment was provided within the Yale Liver Center, the university-based liver specialty clinic. All subjects in this arm were taught how to self-administer therapy (SAT), the PEG and RBV. Subjects followed a pre-specified time period of attending the Liver Center for clinical follow-up and blood work.
1072051|NCT00633243|O1|Outcome|Modified Directly Observed Therapy (mDOT)|Subjects received modified directly observed therapy (mDOT) as part of an adherence intervention. Clinical nurses administered all methadone doses and co-administered the morning RBV dose. The evening dose of RBV was prepackaged by a pharmacist accessible for the subject to self-administer 12 hours later. PEG was administered to mDOT subjects weekly by a licensed practitioners. All mDOT subjects who earned take-home bottles for methadone also received take-home doses of RBV.
1072052|NCT00633243|E2|Reported Event|Self-Administered Therapy (SAT)|Subjects received their methadone remote from their site of HCV treatment. HCV treatment was provided within the Yale Liver Center, the university-based liver specialty clinic. All subjects in this arm were taught how to self-administer therapy (SAT), the PEG and RBV. Subjects followed a pre-specified time period of attending the Liver Center for clinical follow-up and blood work.
1072053|NCT00633243|E1|Reported Event|Modified Directly Observed Therapy (mDOT)|Subjects received modified directly observed therapy (mDOT) as part of an adherence intervention. Clinical nurses administered all methadone doses and co-administered the morning RBV dose. The evening dose of RBV was prepackaged by a pharmacist accessible for the subject to self-administer 12 hours later. PEG was administered to mDOT subjects weekly by a licensed practitioners. All mDOT subjects who earned take-home bottles for methadone also received take-home doses of RBV.
1072054|NCT00633217|B3|Baseline|Total|Total of all reporting groups
1072055|NCT00633217|B2|Baseline|DISKUS 250/50 mcg and Matching HFA MDI Placebo|Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
1072056|NCT00633217|B1|Baseline|HFA MDI 230/42 mcg and Matching DISKUS Placebo|Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
1072057|NCT00633217|P2|Participant Flow|DISKUS 250/50 mcg and Matching HFA MDI Placebo|Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
1072058|NCT00633217|P1|Participant Flow|HFA MDI 230/42 mcg and Matching DISKUS Placebo|Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
1072059|NCT00633217|O2|Outcome|DISKUS 250/50 mcg and Matching HFA MDI Placebo|Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
1072060|NCT00633217|O1|Outcome|HFA MDI 230/42 mcg and Matching DISKUS Placebo|Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
1072061|NCT00633217|O2|Outcome|DISKUS 250/50 mcg and Matching HFA MDI Placebo|Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
1072062|NCT00633217|O1|Outcome|HFA MDI 230/42 mcg and Matching DISKUS Placebo|Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
1072063|NCT00633217|O2|Outcome|DISKUS 250/50 mcg and Matching HFA MDI Placebo|Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
1072064|NCT00633217|O1|Outcome|HFA MDI 230/42 mcg and Matching DISKUS Placebo|Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
1072065|NCT00633217|E2|Reported Event|DISKUS 250/50 mcg and Matching HFA MDI Placebo|Fluticasone Propionate/Salmeterol DISKUS 250/50 mcg twice daily and matching HFA MDI placebo
1072066|NCT00633217|E1|Reported Event|HFA MDI 230/42 mcg and Matching DISKUS Placebo|Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA) 134a metered-dose inhaler (MDI) 230/42 micrograms (mcg) twice daily and matching DISKUS placebo
1072067|NCT00633152|B3|Baseline|Total|Total of all reporting groups
1072068|NCT00633152|B2|Baseline|Linezolid|Intravenous Linezolid every 12 hours (with or without Aztreonam)
1072069|NCT00633152|B1|Baseline|Ceftaroline|Intramuscular every 12 hours
1072070|NCT00633152|P2|Participant Flow|Linezolid|Intravenous Linezolid every 12 hours (with or without Aztreonam)
1072071|NCT00633152|P1|Participant Flow|Ceftaroline|Intramuscular every 12 hours
1072072|NCT00633152|O2|Outcome|Linezolid (With or Without Aztreonam)|Linezolid was administered as 600 mg IV infusions over 60 minutes q12h
1072073|NCT00633152|O1|Outcome|Ceftaroline|Ceftaroline fosamil was administered 600mg IM every 12 hours
1072074|NCT00633152|O2|Outcome|Linezolid (With or Without Aztreonam)|Linezolid was administered as 600 mg Intravenous infusions over 60 minutes every 12 hours
1072075|NCT00633152|O1|Outcome|Ceftaroline|Ceftaroline was administered 600 mg as an Intramuscular injection every 12 hours
1072076|NCT00633152|E2|Reported Event|Linezolid|Intravenous Linezolid every 12 hours (with or without Aztreonam)
1072077|NCT00633152|E1|Reported Event|Ceftaroline|Intramuscular every 12 hours
1072078|NCT00634322|B4|Baseline|Total|Total of all reporting groups
1072079|NCT00634322|B3|Baseline|Arm C, Compassionate Use of Glucarpidase|Compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment. Patients received glucarpidase 50 U/kg
1072080|NCT00634322|B2|Baseline|High-dose Methotrexate Plus Placebo Then Glucarpidase|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart
1072081|NCT00634322|B1|Baseline|High-dose Methotrexate Plus Glucarpidase Then Placebo|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart
1072082|NCT00634322|P3|Participant Flow|Arm C, Compassionate Use of Glucarpidase|Compassionate use group to treat or prevent life threatening toxicity in the event of delayed elimination of MTX and/or renal impairment. Patients received glucarpidase 50 U/kg
1072083|NCT00634322|P2|Participant Flow|High-dose Methotrexate Plus Placebo Then Glucarpidase|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart
1072084|NCT00634322|P1|Participant Flow|High-dose Methotrexate Plus Glucarpidase Then Placebo|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart
1072346|NCT00633919|O1|Outcome|Active|SLITone Dermatophagoides Mix
1072347|NCT00633919|O2|Outcome|Placebo|SLITone Placebo
1072089|NCT00634322|E2|Reported Event|High-dose Methotrexate Plus Placebo Then Glucarpidase|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart
1072090|NCT00634322|E1|Reported Event|High-dose Methotrexate Plus Glucarpidase Then Placebo|First cycle: High-dose methotrexate with leucovorin, plus 2 doses of glucarpidase 24 hours apart Second cycle: High-dose methotrexate with leucovorin, plus 2 doses of placebo 24 hours apart
1072091|NCT00634270|B3|Baseline|Total|Total of all reporting groups
1072092|NCT00634270|B2|Baseline|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
1072093|NCT00634270|B1|Baseline|Stratum 1|"Design~Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Disease status will be evaluated using volumetric MRI analysis at regular intervals.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
1072094|NCT00634270|P2|Participant Flow|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
1072095|NCT00634270|P1|Participant Flow|Stratum 1|"Design~Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Disease status will be evaluated using volumetric MRI analysis at regular intervals.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
1072096|NCT00634270|O1|Outcome|Stratum 1|"Design~• Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause significant morbidity treated with sirolimus. The second stratum will evaluate objective radiographic response to sirolimus in children and adults with NF1 and inoperable plexiform neurofibromas with the potential to cause significant morbidity that do not have documented progression of the PN at time of trial entry."
1072097|NCT00634270|O2|Outcome|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
1072098|NCT00634270|O1|Outcome|Stratum 1|"Design~Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Disease status will be evaluated using volumetric MRI analysis at regular intervals.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
1072099|NCT00634270|O2|Outcome|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
1072100|NCT00634270|O1|Outcome|Stratum 1|"Design~Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Disease status will be evaluated using volumetric MRI analysis at regular intervals.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
1072101|NCT00634270|O2|Outcome|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
1072102|NCT00634270|O1|Outcome|Stratum 1|"Design~Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Disease status will be evaluated using volumetric MRI analysis at regular intervals.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
1072103|NCT00634270|O2|Outcome|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
1072104|NCT00634270|O1|Outcome|Stratum 1|"Design~Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Disease status will be evaluated using volumetric MRI analysis at regular intervals.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
1072105|NCT00634270|O1|Outcome|Stratum 1|"Design~• Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause significant morbidity treated with sirolimus. The second stratum will evaluate objective radiographic response to sirolimus in children and adults with NF1 and inoperable plexiform neurofibromas with the potential to cause significant morbidity that do not have documented progression of the PN at time of trial entry."
1072106|NCT00634270|O1|Outcome|Stratum 1|"Design~• Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause significant morbidity treated with sirolimus. The second stratum will evaluate objective radiographic response to sirolimus in children and adults with NF1 and inoperable plexiform neurofibromas with the potential to cause significant morbidity that do not have documented progression of the PN at time of trial entry."
1072107|NCT00634270|O1|Outcome|Stratum 1|"Design~• Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause significant morbidity treated with sirolimus. The second stratum will evaluate objective radiographic response to sirolimus in children and adults with NF1 and inoperable plexiform neurofibromas with the potential to cause significant morbidity that do not have documented progression of the PN at time of trial entry."
1072108|NCT00634270|O1|Outcome|Stratum 1|"Design~• Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing. Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
1072109|NCT00634270|O1|Outcome|Stratum 1|"Design~• Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing. Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
1072110|NCT00634270|O1|Outcome|Stratum 1|"Design~• Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing."
1072111|NCT00634270|O2|Outcome|Stratum 2|Patients ≥ 3 years old and plexiform neurofibroma(s) without documented radiographic progression at trial entry. The endpoint will be radiographic response.
1072112|NCT00634270|O1|Outcome|Stratum 1|Patients ≥ 3 years old with progressive plexiform neurofibroma(s) with the potential to cause significant morbidity.
1072113|NCT00634270|O1|Outcome|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
1072114|NCT00634270|O2|Outcome|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
1072115|NCT00634270|O1|Outcome|Stratum 1|"Design~Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing.~Disease status will be evaluated using volumetric MRI analysis at regular intervals.~Sirolimus, Rapamycin: This phase II study will evaluate children and adults with neurofibromatosis type-1 (NF1) and plexiform neurofibromas treated with sirolimus. It is divided in two strata. The first stratum will evaluate time to progression (TTP) in children and adults with NF1 and progressive plexiform neurofibromas with the potential to cause sign"
1072116|NCT00634270|E2|Reported Event|Stratum 2|Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression
1072117|NCT00634270|E1|Reported Event|Stratum 1|"Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity with evidence of progression.~Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing. Disease status will be evaluated using volumetric MRI analysis at regular intervals."
1072118|NCT00634244|B4|Baseline|Total|Total of all reporting groups
1072119|NCT00634244|B3|Baseline|Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)|Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)
1072120|NCT00634244|B2|Baseline|Arm B (Alvocidib+Cytarabine+Mitoxantrone)|Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.
1072121|NCT00634244|B1|Baseline|Arm A (Carboplatin+Topotecan Hydrochloride)|Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.
1072122|NCT00634244|P3|Participant Flow|Arm C (Mitoxantrone Hydrochloride, Cytarabine, Sirolimus)|"Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)~mitoxantrone hydrochloride: Given IV~cytarabine: Given IV~sirolimus: Given PO~etoposide: Given IV"
1072123|NCT00634244|P2|Participant Flow|Arm B (Alvocidib, Mitoxantrone Hydrochloride, Cytarabine)|"Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.~alvocidib: Given IV~mitoxantrone hydrochloride: Given IV~cytarabine: Given IV"
1072124|NCT00634244|P1|Participant Flow|Arm A (Carboplatin and Topotecan Hydrochloride)|"Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.~carboplatin: Given IV~topotecan hydrochloride: Given IV"
1072125|NCT00634244|O3|Outcome|Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)|Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)
1072348|NCT00633919|O1|Outcome|Active|SLITone Dermatophagoides Mix
1072349|NCT00633919|O2|Outcome|Placebo|SLITone Placebo
1072128|NCT00634244|O3|Outcome|Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)|Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)
1072129|NCT00634244|O2|Outcome|Arm B (Alvocidib+Cytarabine+Mitoxantrone)|Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.
1072130|NCT00634244|O1|Outcome|Arm A (Carboplatin+Topotecan Hydrochloride)|Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.
1072131|NCT00634244|E3|Reported Event|Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)|Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)
1072132|NCT00634244|E2|Reported Event|Arm B (Alvocidib+Cytarabine+Mitoxantrone)|Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.
1072133|NCT00634244|E1|Reported Event|Arm A (Carboplatin+Topotecan Hydrochloride)|Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.
1072134|NCT00634179|B1|Baseline|Treatment (VR-CHOP Regimen)|"INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression.~MAINTENANCE: Patients achieving complete response (CR) receive rituximab IV once every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or partial response (PR) receive rituximab IV and bortezomib once weekly for 4 weeks every 6 months for up to 2 years in the absence of disease progression or unacceptable toxicity."
1072135|NCT00634179|P1|Participant Flow|Treatment (VR-CHOP Regimen)|"Phase I will identify the maximal tolerated doses of bortezomib and vincristine when used in a combination of bortezomib, rituximab and the cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy regimen.~In Phase II, the trial will evaluate the efficacy and safety of the MTD combination of VELCADE and rituximab-CHOP in additional subjects who have untreated follicular B-cell non-Hodgkin's lymphoma (B-NHL)(Grade 1, 2, 3a), small lymphocytic lymphoma, or marginal zone lymphoma."
1072136|NCT00634179|O2|Outcome|Phase II: Maintenance|"INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression.~MAINTENANCE: Patients achieving CR receive rituximab IV once every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or PR receive rituximab IV and bortezomib once weekly for 4 weeks every 6 months for up to 2 years in the absence of disease progression or unacceptable toxicity.~Bortezomib: Bortezomib 1.6 mg/m² given on days 1 and 8~Rituximab: Rituximab 375 mg/m²~Doxorubicin: Doxorubicin 50 mg/m²~Cyclophosphamide: Cyclophosphamide 750 mg/m²~Vincristine: Vincristine 1.4 mg/m² (capped at 1.5 mg maximum) given on day 1~Prednisone: Prednisone 100 mg/day given orally on"
1072137|NCT00634179|O1|Outcome|Phase I: Induction|INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression.
1072138|NCT00634179|O1|Outcome|MTD of Bortezomib With Vincristine Capped at 1.5 mg|Maximal tolerated dose (MTD) of bortezomib when vincristine is capped at 1.5 mg
1072139|NCT00634179|E2|Reported Event|Phase II: Maintenance|In Phase II, the trial will evaluate the efficacy and safety of the MTD combination of VELCADE and rituximab-CHOP in additional subjects who have untreated follicular B-NHL. (Grade 1, 2, 3a), small lymphocytic lymphoma, or marginal zone lymphoma.
1072140|NCT00634179|E1|Reported Event|Phase I: Induction|Phase I will identify the maximal tolerated doses of bortezomib and vincristine when used in a combination of bortezomib, rituximab and the CHOP chemotherapy regimen.
1072141|NCT00634166|B3|Baseline|Total|Total of all reporting groups
1072142|NCT00634166|B2|Baseline|Prospective Patients/Active Drug|"Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1).~Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
1072143|NCT00634166|B1|Baseline|Historical Control|"Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago)~Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
1072144|NCT00634166|P2|Participant Flow|Prospective Patients/Active Drug|"Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1).~Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
1072145|NCT00634166|P1|Participant Flow|Historical Control|"Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago)~Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
1072350|NCT00633919|O1|Outcome|Active|SLITone Dermatophagoides Mix
1072351|NCT00633919|O2|Outcome|Placebo|SLITone Placebo
1072146|NCT00634166|O2|Outcome|Prospective Patients/Active Drug|"Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1).~Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
1072147|NCT00634166|O1|Outcome|Historical Control|"Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago)~Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
1072148|NCT00634166|E2|Reported Event|Prospective Patients/Active Drug|"Prospective subjects with thermal injuries of 20-60% TBSA on the chest, abdomen, or proximal upper and lower extremities requiring meshed autografts on these areas will receive SS5% as the initial topical moist dressing over the meshed autograft(s) placed at the initial graft procedure (Day 1).~Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
1072149|NCT00634166|E1|Reported Event|Historical Control|"Treated within the last 5 years (if possible) with topical prophylactic therapies that did not include mafenide acetate or mafenide salt forms (with the sponsor's prior approval, sites may obtain historical control subjects treated longer than 5 years ago)~Sulfamylon® (mafenide acetate) For 5 % Topical Solution: Sulfamylon® For 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds."
1072150|NCT00634114|B4|Baseline|Total|Total of all reporting groups
1072151|NCT00634114|B3|Baseline|Comparator: Omeprazole 10 mg|Omeprazole 10 mg once daily
1072152|NCT00634114|B2|Baseline|Experimental: Esomeprazole 10 mg|Esomeprazole 10 mg once daily
1072153|NCT00634114|B1|Baseline|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily
1072154|NCT00634114|P3|Participant Flow|Comparator: Omeprazole 10 mg|Omeprazole 10 mg once daily
1072155|NCT00634114|P2|Participant Flow|Experimental: Esomeprazole 10 mg|Esomeprazole 10 mg once daily
1072156|NCT00634114|P1|Participant Flow|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily
1072157|NCT00634114|O3|Outcome|Comparator: Omeprazole 10 mg|Omeprazole 10 mg once daily
1072158|NCT00634114|O2|Outcome|Experimental: Esomeprazole 10 mg|Esomeprazole 10 mg once daily
1072159|NCT00634114|O1|Outcome|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily
1072160|NCT00634114|O3|Outcome|Comparator: Omeprazole 10 mg|Omeprazole 10 mg once daily
1072161|NCT00634114|O2|Outcome|Experimental: Esomeprazole 10 mg|Esomeprazole 10 mg once daily
1072162|NCT00634114|O1|Outcome|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily
1072163|NCT00634114|O3|Outcome|Comparator: Omeprazole 10 mg|Omeprazole 10 mg once daily
1072164|NCT00634114|O2|Outcome|Experimental: Esomeprazole 10 mg|Esomeprazole 10 mg once daily
1072165|NCT00634114|O1|Outcome|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily
1072166|NCT00634114|E3|Reported Event|Comparator: Omeprazole 10 mg|Omeprazole 10 mg once daily
1072167|NCT00634114|E2|Reported Event|Experimental: Esomeprazole 10 mg|Esomeprazole 10 mg once daily
1072168|NCT00634114|E1|Reported Event|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily
1072169|NCT00634088|B5|Baseline|Total|Total of all reporting groups
1072170|NCT00634088|B4|Baseline|Ixabepilone + Lapatinib + Capecitabine|A triplet combination of ixabepilone, lapatinib, and capecitabine was planned for analysis in escalating doses but was not initiated due to premature termination of the study.
1072171|NCT00634088|B3|Baseline|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg|Initiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m^2 + lapatinib, 1250 mg), lapatinib 1250 mg administered orally once a day, every day for 7 to 14 consecutive days prior to the first administration of ixabepilone in Cycle 1. Then lapatinib administered daily, orally once a day, for a 21-day cycle. Ixabepilone administered as a 3-hour IV infusion of 40 mg/m^2 following lapatinib lead-in period.
1072172|NCT00634088|B2|Baseline|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg|Initiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m^2 + lapatinib, 1000 mg), lapatinib 1250 mg administered orally once a day, every day, for 7 to 14 consecutive days prior to the first administration of ixabepilone. Then lapatinib administered orally once a day, every day, for a 21-day cycle. After lapatinib lead-in period, ixabepilone administered as a 3-hour IV infusion of 32 mg/m^2.
1072173|NCT00634088|B1|Baseline|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg|Lapatinib administered daily in escalating cohorts, beginning with 1000 mg, orally once a day, for 7 to 14 consecutive days in Cycle 1 prior to the first administration of ixabepilone. Then lapatinib administered daily, orally once a day, for a 21-day cycle. After the lapatinib lead-in phase, ixabepilone administered as a 3-hour IV infusion in escalating doses, beginning with 32 mg/m^2.
1072174|NCT00634088|P4|Participant Flow|Ixabepilone+ Lapatinib + Capecitabine|A triplet combination of ixabepilone, lapatinib, and capecitabine was planned for analysis in escalating doses but was not initiated due to premature termination of the study.
1072175|NCT00634088|P3|Participant Flow|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg|Initiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m^2 + lapatinib, 1250 mg). Lapatinib, 1250 mg, administered daily, orally once a day, for 7 to 14 consecutive days prior to the first administration of ixabepilone (Day 1). After the lapatinib lead-in phase, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib administered daily, orally once a day, for 21-day cycle.
1072211|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
1072352|NCT00633919|O1|Outcome|Active|SLITone Dermatophagoides Mix
1072353|NCT00633919|O2|Outcome|Placebo|SLITone Placebo
1072176|NCT00634088|P2|Participant Flow|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg|Initiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m^2 + lapatinib, 1000 mg). Lapatinib, 1250 mg, administered daily, orally once a day, for 7 to 14 consecutive days prior to the first administration of ixabepilone (Day 1). After the lapatinib lead-in phase, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib administered daily, orally once a day, for 21-day cycle.
1072177|NCT00634088|P1|Participant Flow|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg|Lapatinib, 1000 mg, administered daily in a lead-in period, orally once a day, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib administered daily, orally once a day, for 21-day cycle.
1072178|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
1072179|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
1072180|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
1072181|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
1072182|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
1072183|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
1072184|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
1072185|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
1072186|NCT00634088|O1|Outcome|All Treated|All participants who received at least 1 dose of ixabepilone or lapatinib.
1072187|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
1072188|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
1072189|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
1072190|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
1072191|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
1072192|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
1072193|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
1072194|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
1072195|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
1072196|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
1072197|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
1072198|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
1072199|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
1072200|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
1072201|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
1072202|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
1072203|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
1072204|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
1072205|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
1072206|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
1072207|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
1072208|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
1072209|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
1072210|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
1072354|NCT00633919|O1|Outcome|Active|SLITone Dermatophagoides Mix
1072212|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
1072213|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
1072214|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
1072215|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
1072216|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
1072217|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
1072218|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
1072219|NCT00634088|O4|Outcome|Ixabepilone + Lapatinib + Capecitabine|Planned escalating doses of ixabepilone, 32 to 40 mg/m^2 + lapatinib, 1000 to 1250 mg + capecitabine, 1650 to 2000 mg/m^2. No participants were enrolled in this arm due to premature termination of the study.
1072220|NCT00634088|O3|Outcome|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
1072221|NCT00634088|O2|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1 and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for a 21-day cycle.
1072222|NCT00634088|O1|Outcome|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m^2, administered as a 3-hour intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle.
1072223|NCT00634088|O1|Outcome|All Treated|All participants who received at least 1 dose of ixabepilone or lapatinib.
1072224|NCT00634088|E3|Reported Event|Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily in a lead-in period, orally once a day, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase, ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for 21-day cycle.
1072225|NCT00634088|E2|Reported Event|Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d|Lapatinib, 1250 mg, administered daily in a lead-in period, orally once a day, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered daily, orally once a day, for 21-day cycle.
1072226|NCT00634088|E1|Reported Event|Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d|Lapatinib, 1000 mg, administered daily in a lead-in period, orally once a day, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After the lapatinib lead-in phase, ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for 21-day cycle.
1072227|NCT00634049|B1|Baseline|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day administered intravenously (IV) or orally (PO) [or per os (PO)] for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 180 days; with an option for extended treatment under specified criteria.
1072228|NCT00634049|P1|Participant Flow|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day administered intravenously (IV) or orally (PO) [or per os (PO)] for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 180 days; with an option for extended treatment under specified criteria.
1072262|NCT00634049|O10|Outcome|mITT-Other Mixed Infection|Other Mixed Infections mITT population consisted of 15 participants who have had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
1072355|NCT00633919|E2|Reported Event|Placebo|SLITone Placebo
1072229|NCT00634049|O1|Outcome|Isavuconazole|Participants received Isavuconazole intravenous (IV) or per oral (PO) over period of 2 days, on days 1 and 2 three doses of 200 mg were administered every 8 hours for a total of six doses. From Day 3 to End of Treatment (EOT) maintenance dose of 200 mg isavuconazole was administered once daily up to 180 days; with an option for extended treatment under specified criteria.
1072230|NCT00634049|O2|Outcome|Not Renally Impaired|Not Renally Impaired (NRI) population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
1072231|NCT00634049|O1|Outcome|Renally Impaired|Renally Impaired (RI) population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. Renal impairment was defined as yes for participants who had a baseline eGFR-MDRD < 60 mL/min/1.73 m^2, no for patients who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
1072232|NCT00634049|O10|Outcome|mITT-Other Mixed Infection|Other Mixed Infections mITT group consisted of 15 participants who had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
1072233|NCT00634049|O9|Outcome|mITT- Other Non-Candida Yeast|Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
1072234|NCT00634049|O8|Outcome|mITT- Other Dimorphic Fungi|Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
1072235|NCT00634049|O7|Outcome|mITT- Other Mould Species Only|Other Mould Species mITT population consisted of 7 participants who had proven or probable IFD as determined by the DRC caused by mould species.
1072236|NCT00634049|O6|Outcome|mITT- Other Filamentous Fungi|Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
1072237|NCT00634049|O5|Outcome|mITT - Mucorales (Intolerant)|Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior AFT.
1072238|NCT00634049|O4|Outcome|mITT - Mucorales (Refractory)|Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior AFT
1072239|NCT00634049|O3|Outcome|mITT - Mucorales (Primary Therapy)|Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
1072240|NCT00634049|O2|Outcome|mITT - Aspergillus [Not Renally Impaired]|Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
1072241|NCT00634049|O1|Outcome|mITT - Aspergillus [Renally Impaired]|Aspergillus - Renally Impaired (RI) mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status, and whether they are renally impaired and not renally impaired. Renal impairment was defined as yes for participants who had a baseline estimated glomerular filtration rate (eGFR-MDRD) < 60 mL/min/1.73 m^2, no for participants who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
1072242|NCT00634049|O10|Outcome|mITT-Other Mixed Infection|Other Mixed Infections mITT group consisted of 15 participants who had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
1072243|NCT00634049|O9|Outcome|mITT- Other Non-Candida Yeast|Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
1072244|NCT00634049|O8|Outcome|mITT- Other Dimorphic Fungi|Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
1072245|NCT00634049|O7|Outcome|mITT- Other Mould Species Only|Other Mould Species mITT population consisted of 7 participants who had proven or probable IFD as determined by the DRC caused by mould species.
1072246|NCT00634049|O6|Outcome|mITT- Other Filamentous Fungi|Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
1072247|NCT00634049|O5|Outcome|mITT - Mucorales (Intolerant)|Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior AFT.
1072248|NCT00634049|O4|Outcome|mITT - Mucorales (Refractory)|Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior AFT
1072249|NCT00634049|O3|Outcome|mITT - Mucorales (Primary Therapy)|Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
1072250|NCT00634049|O2|Outcome|mITT - Aspergillus [Not Renally Impaired]|Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
1072251|NCT00634049|O1|Outcome|mITT - Aspergillus [Renally Impaired]|Aspergillus - Renally Impaired (RI) mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status, and whether they are renally impaired and not renally impaired. Renal impairment was defined as yes for participants who had a baseline estimated glomerular filtration rate (eGFR-MDRD) < 60 mL/min/1.73 m^2, no for patients who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
1072252|NCT00634049|O10|Outcome|mITT-Other Mixed Infection|Other Mixed Infections mITT group consisted of 15 participants who had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
1072253|NCT00634049|O9|Outcome|mITT- Other Non-Candida Yeast|Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
1072254|NCT00634049|O8|Outcome|mITT- Other Dimorphic Fungi|Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
1072255|NCT00634049|O7|Outcome|mITT- Other Mould Species Only|Other Mould Species mITT population consisted of 7 participants who had proven or probable IFD as determined by the DRC caused by mould species.
1072256|NCT00634049|O6|Outcome|mITT- Other Filamentous Fungi|Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
1072257|NCT00634049|O5|Outcome|mITT - Mucorales (Intolerant)|Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior AFT.
1072258|NCT00634049|O4|Outcome|mITT - Mucorales (Refractory)|Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior AFT
1072259|NCT00634049|O3|Outcome|mITT - Mucorales (Primary Therapy)|Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
1072260|NCT00634049|O2|Outcome|mITT - Aspergillus [Not Renally Impaired]|Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
1072261|NCT00634049|O1|Outcome|mITT - Aspergillus [Renally Impaired]|Aspergillus - Renally Impaired (RI) mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status, and whether they are renally impaired and not renally impaired. Renal impairment was defined as yes for participants who had a baseline estimated glomerular filtration rate (eGFR-MDRD) < 60 mL/min/1.73 m^2, no for participants who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
1072356|NCT00633919|E1|Reported Event|Active|SLITone Dermatophagoides Mix
1072263|NCT00634049|O9|Outcome|mITT- Other Non-Candida Yeast|Other Non Candida Yeast mITT population consisted of 11 participants who have had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus NOS and 2 Trichosporon).
1072264|NCT00634049|O8|Outcome|mITT- Other Dimorphic Fungi|Other Dimorphic Fungi mITT population consisted of 29 participants who have had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes,9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
1072265|NCT00634049|O7|Outcome|mITT- Other Mould Species Only|Other Mould Species mITT population consisted of 7 participants who have had proven or probable IFD as determined by the DRC caused by mould species.
1072266|NCT00634049|O6|Outcome|mITT-Other Filamentous Fungi|Other Filamentous Fungi mITT population consisted of 17 participants who have had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium,2 Exophiala,2 Cladosporium,2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia,Exserohilum, Paecilomyces,Pseudallescheria and Scedosporium).
1072267|NCT00634049|O5|Outcome|mITT - Mucorales (Intolerant)|Mucorales – Intolerant mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior AFT.
1072268|NCT00634049|O4|Outcome|mITT - Mucorales (Refractory)|Mucorales – Refractory Therapy mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior AFT.
1072269|NCT00634049|O3|Outcome|mITT - Mucorales (Primary Therapy)|Mucorales – Primary Therapy mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
1072270|NCT00634049|O2|Outcome|mITT - Aspergillus [Not Renally Impaired]|Aspergillus - Renally Impaired mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participants IFD. The Aspergillus-mITT population was presented by renal status, renally impaired and not renally impaired. Overall there were 24 participants in the mITTAspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
1072271|NCT00634049|O1|Outcome|mITT - Aspergillus [Renally Impaired]|Aspergillus - Renally Impaired mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participants IFD. The Aspergillus-mITT population was presented by renal status, renally impaired and not renally impaired. Renal impairment was defined as yes for participants who have a baseline estimated glomerular filtration rate (eGFR-MDRD) < 60 mL/min/1.73 m^2, no for participants who have a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
1072272|NCT00634049|O10|Outcome|mITT-Other Mixed Infection|Other Mixed Infections mITT population consisted of 15 participants who have had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
1072273|NCT00634049|O9|Outcome|mITT- Other Non-Candida Yeast|Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
1072274|NCT00634049|O8|Outcome|mITT- Other Dimorphic Fungi|Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
1072275|NCT00634049|O7|Outcome|mITT- Other Mould Species Only|Other Mould Species mITT population consisted of 7 participants who have had proven or probable IFD as determined by the DRC caused by mould species.
1072276|NCT00634049|O6|Outcome|mITT-Other Filamentous Fungi|Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
1072277|NCT00634049|O5|Outcome|mITT - Mucorales (Intolerant)|Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior AFT.
1072278|NCT00634049|O4|Outcome|mITT - Mucorales (Refractory)|Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior AFT.
1072279|NCT00634049|O3|Outcome|mITT - Mucorales (Primary Therapy)|Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
1072331|NCT00633932|O3|Outcome|Comparator: Omeprazole 20mg|Omeprazole 20mg once daily
1072357|NCT00633893|B4|Baseline|Total|Total of all reporting groups
1072280|NCT00634049|O2|Outcome|mITT - Aspergillus [Not Renally Impaired]|Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
1072281|NCT00634049|O1|Outcome|mITT - Aspergillus [Renally Impaired]|Aspergillus - Renally Impaired mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participants IFD. The Aspergillus-mITT population was presented by renal status, renally impaired and not renally impaired. Renal impairment was defined as yes for participants who have a baseline estimated glomerular filtration rate (eGFR-MDRD) < 60 mL/min/1.73 m^2, no for participants who have a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
1072282|NCT00634049|O10|Outcome|mITT-Other Mixed Infection|Other Mixed Infections mITT group consisted of 15 participants who had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
1072283|NCT00634049|O9|Outcome|mITT- Other Non-Candida Yeast|Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
1072284|NCT00634049|O8|Outcome|mITT- Other Dimorphic Fungi|Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
1072285|NCT00634049|O7|Outcome|mITT- Other Mould Species Only|Other Mould Species mITT population consisted of 7 participants who have had proven or probable IFD as determined by the DRC caused by mould species.
1072286|NCT00634049|O6|Outcome|mITT-Other Filamentous Fungi|Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
1072287|NCT00634049|O5|Outcome|mITT - Mucorales (Intolerant)|Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior AFT.
1072288|NCT00634049|O4|Outcome|mITT - Mucorales (Refractory)|Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior AFT.
1072289|NCT00634049|O3|Outcome|mITT - Mucorales (Primary Therapy)|Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
1072290|NCT00634049|O2|Outcome|mITT - Aspergillus [Not Renally Impaired]|Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
1072291|NCT00634049|O1|Outcome|mITT - Aspergillus [Renally Impaired]|Aspergillus - Renally Impaired (RI) mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status, and whether they are renally impaired or not renally impaired. Renal impairment was defined as yes for participants who had a baseline estimated glomerular filtration rate (eGFR-MDRD) < 60 mL/min/1.73 m^2, no for patients who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
1072292|NCT00634049|O10|Outcome|mITT-Other Mixed Infection|Other Mixed Infections mITT group consisted of 15 participants who had proven or probable IFD as determined by the DRC caused by mixed infections aspergillosis/mucormycosis.
1072293|NCT00634049|O9|Outcome|mITT- Other Non-Candida Yeast|Other non-Candida Yeast mITT population consisted of 11 participants who had proven or probable IFD as determined by the DRC caused by non-Candida yeast (4 Cryptococcus neoformans, 3 Cryptococcus gatii, 2 Cryptococcus not otherwise specified (NOS) and 2 Trichosporon).
1072294|NCT00634049|O8|Outcome|mITT- Other Dimorphic Fungi|Other Dimorphic Fungi mITT population consisted of 29 participants who had proven or probable IFD as determined by the DRC caused by dimorphic fungi (10 Paracoccidiodes, 9 Coccidiodides, 7 Histoplasma, 3 Blastomyces).
1072295|NCT00634049|O7|Outcome|mITT- Other Mould Species Only|Other Mould Species mITT population consisted of 7 participants who had proven or probable IFD as determined by the DRC caused by mould species.
1072296|NCT00634049|O6|Outcome|mITT- Other Filamentous Fungi|Other Filamentous Fungi mITT population consisted of 17 participants who had proven or probable IFD as determined by the DRC caused by other filamentous fungi (4 Fusarium, 2 Exophiala, 2 Cladosporium, 2 Scopulariopsis and 1 each of Acremonium, Alternaria, Curvularia, Exserohilum, Paecilomyces, Pseudallescheria and Scedosporium).
1072332|NCT00633932|O2|Outcome|Experimental: Esomeprazole 20mg|Esomeprazole 20mg once daily
1072333|NCT00633932|O1|Outcome|Experimental: Esomeprazole 40mg|Esomeprazole 40mg once daily
1072297|NCT00634049|O5|Outcome|mITT - Mucorales (Intolerant)|Mucorales - Intolerant mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participant had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 5 participants who were intolerant to prior antifungal therapy (AFT).
1072298|NCT00634049|O4|Outcome|mITT - Mucorales (Refractory)|Mucorales - Refractory Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed to have proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis).The DRC also categorized each participant by therapy status; these groups were primary therapy, refractory and intolerant. There were 11 participants whose IFD was refractory to prior antifungal therapy (AFT)
1072299|NCT00634049|O3|Outcome|mITT - Mucorales (Primary Therapy)|Mucorales - Primary Therapy mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Based on the DRC assessment 37 participants were assessed proven or probable Mucorales infection (32 participants had proven and 5 participants had probable invasive mucormycosis). The DRC also categorized each patient by therapy status; these groups were primary therapy, refractory and intolerant. There were 21 participants receiving isavuconazole as a primary therapy.
1072300|NCT00634049|O2|Outcome|mITT - Aspergillus [Not Renally Impaired]|Aspergillus - Not Renally Impaired (NRI) mITT population consisted of participants who had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status (Renally Impaired and Not Renally Impaired). Overall there were 24 participants in the mITT- Aspergillus population out of which 4 participants were classified as Not Renally Impaired (NRI).
1072301|NCT00634049|O1|Outcome|mITT - Aspergillus [Renally Impaired]|Aspergillus - Renally Impaired (RI) mITT population consisted of participants who have had proven or probable IFD as determined by the DRC. Classification by the DRC was based on the type of pathogen which was found to be the cause of participant's IFD. The Aspergillus-mITT population was presented by renal status, and whether they are renally impaired and not renally impaired. Renal impairment was defined as yes for participants who had a baseline estimated glomerular filtration rate (eGFR-MDRD) < 60 mL/min/1.73 m^2, no for patients who had a baseline eGFR-MDRD ≥ 60 mL/min/1.73 m^2. Overall there were 24 participants in the mITT-Aspergillus population out of which 20 participants were classified as Renally Impaired (RI).
1072302|NCT00634049|E2|Reported Event|Not Renally Impaired (NRI)|"Not Renally impaired participants were defined as no if they have a baseline eGFR-MDRD~≥ 60 mL/min/1.73 m^2 by the Modification of Diet in Renal Disease (MDRD) formula."
1072303|NCT00634049|E1|Reported Event|Renally Impaired (RI)|Renal impairment was defined as yes for participants who have a baseline as eGFR < 60 mL/min/1.73 m^2 by the Modification of Diet in Renal Disease (MDRD) formula.
1072304|NCT00634010|B3|Baseline|Total|Total of all reporting groups
1072305|NCT00634010|B2|Baseline|Methadone Capsule|Methadone 5 mg orally every 12 hours + additional as needed doses up to 40-50 mg/day
1072306|NCT00634010|B1|Baseline|Morphine Capsule|Morphine 15 mg slow release orally every 12 hours + additional doses as needed
1072307|NCT00634010|P2|Participant Flow|Methadone Capsule|Methadone 5 mg orally every 12 hours and 5 mg immediate-release (IR) Morphine every 2 hours as needed for rescue pain (for first week).
1072308|NCT00634010|P1|Participant Flow|Morphine Capsule|Morphine 5 mg slow release morphine orally every 12 hours and 5 mg immediate-release morphine every 2 hours as needed for breakthrough pain.
1072309|NCT00634010|O2|Outcome|Methadone Capsule|Methadone 5 mg orally every 12 hours + additional as needed doses up to 40-50 mg/day
1072310|NCT00634010|O1|Outcome|Morphine Capsule|Morphine 15 mg slow release orally every 12 hours + additional doses as needed
1072311|NCT00634010|E2|Reported Event|Methadone Capsule|Methadone 5 mg orally every 12 hours + additional as needed doses up to 40-50 mg/day
1072312|NCT00634010|E1|Reported Event|Morphine Capsule|Morphine 15 mg slow release orally every 12 hours + additional doses as needed
1072313|NCT00633984|B3|Baseline|Total|Total of all reporting groups
1072314|NCT00633984|B2|Baseline|Cognitive Behavioral Group Therapy + 50mg Placebo|Participants received Cognitive Behavioral Group Therapy and 50mg Placebo.
1072315|NCT00633984|B1|Baseline|Cognitive Behavioral Group Therapy + 50mg D-Cycloserine|Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine.
1072316|NCT00633984|P2|Participant Flow|Cognitive Behavioral Group Therapy + 50mg Placebo|Participants received Cognitive Behavioral Group Therapy and 50mg Placebo.
1072317|NCT00633984|P1|Participant Flow|Cognitive Behavioral Group Therapy + 50mg D-Cycloserine|Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine.
1072318|NCT00633984|O2|Outcome|Cognitive Behavioral Group Therapy + 50mg Placebo|Participants received Cognitive Behavioral Group Therapy and 50mg Placebo.
1072319|NCT00633984|O1|Outcome|Cognitive Behavioral Group Therapy + 50mg D-Cycloserine|Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine.
1072320|NCT00633984|O2|Outcome|Cognitive Behavioral Group Therapy + 50mg Placebo|Participants received Cognitive Behavioral Group Therapy and 50mg Placebo.
1072321|NCT00633984|O1|Outcome|Cognitive Behavioral Group Therapy + 50mg D-Cycloserine|Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine.
1072322|NCT00633984|E2|Reported Event|Cognitive Behavioral Therapy + Placebo|Participants received Cognitive Behavioral Group Therapy and Placebo.
1072323|NCT00633984|E1|Reported Event|Cognitive Behavioral Therapy + DCS|Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine.
1072324|NCT00633932|B4|Baseline|Total|Total of all reporting groups
1072325|NCT00633932|B3|Baseline|Comparator: Omeprazole 20mg|Omeprazole 20mg once daily
1072326|NCT00633932|B2|Baseline|Experimental: Esomeprazole 20mg|Esomeprazole 20mg once daily
1072327|NCT00633932|B1|Baseline|Experimental: Esomeprazole 40mg|Esomeprazole 40mg once daily
1072328|NCT00633932|P3|Participant Flow|Comparator: Omeprazole 20mg|Omeprazole 20mg once daily
1072329|NCT00633932|P2|Participant Flow|Experimental: Esomeprazole 20mg|Esomeprazole 20mg once daily
1072330|NCT00633932|P1|Participant Flow|Experimental: Esomeprazole 40mg|Esomeprazole 40mg once daily
1072358|NCT00633893|B3|Baseline|Placebo|Participants received matching placebo oral tablet BID.
1072359|NCT00633893|B2|Baseline|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
1072360|NCT00633893|B1|Baseline|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
1072361|NCT00633893|P3|Participant Flow|Placebo|Participants received matching placebo oral tablet BID.
1072362|NCT00633893|P2|Participant Flow|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
1072363|NCT00633893|P1|Participant Flow|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban twice a day (BID)
1072364|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
1072365|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
1072366|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
1072367|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
1072368|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
1072369|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
1072370|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
1072371|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
1072372|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
1072373|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
1072374|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
1072375|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
1072376|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
1072377|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
1072378|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
1072379|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
1072380|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
1072381|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
1072382|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
1072383|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
1072384|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
1072385|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
1072386|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
1072387|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
1072388|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
1072389|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
1072390|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
1072391|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
1072392|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
1072393|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
1072394|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
1072395|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
1072396|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
1072397|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
1072398|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
1072399|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
1072400|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
1072401|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
1072402|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
1072403|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
1072404|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
1072405|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
1072406|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
1072407|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
1072408|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
1072409|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
1072410|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
1072411|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
1072412|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
1072413|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
1072414|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
1072415|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
1072416|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
1072417|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
1072418|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
1072419|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
1072420|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
1072421|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
1072422|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
1072423|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
1072424|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
1072425|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
1072426|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
1072427|NCT00633893|O3|Outcome|Placebo|Participants received matching placebo oral tablet BID.
1072428|NCT00633893|O2|Outcome|Apixaban 5 mg|Participants received 5 mg oral tablet apixaban BID.
1072429|NCT00633893|O1|Outcome|Apixaban 2.5 mg|Participants received 2.5 mg oral tablet apixaban BID.
1072430|NCT00633893|E3|Reported Event|Placebo|Participants received oral tablet of placebo BID
1072431|NCT00633893|E2|Reported Event|Apixaban 5mg|Participants received 5 mg oral tablet apixaban BID
1072432|NCT00633893|E1|Reported Event|Apixaban 2.5mg|Participants received 2.5 mg oral tablet apixaban BID
1072433|NCT00633880|B4|Baseline|Total|Total of all reporting groups
1072434|NCT00633880|B3|Baseline|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1072435|NCT00633880|B2|Baseline|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1072436|NCT00633880|B1|Baseline|Not Randomized|Entered open-label droxidopa dose titration, but did not randomize
1072437|NCT00633880|P3|Participant Flow|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1072438|NCT00633880|P2|Participant Flow|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1072439|NCT00633880|P1|Participant Flow|Open Label Titration|All patients titrated to their optimal dose of droxidopa during an initial open label phase for 7-14 days
1072440|NCT00633880|O2|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1072441|NCT00633880|O1|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1072442|NCT00633880|O2|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1072443|NCT00633880|O1|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1072444|NCT00633880|O2|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1072445|NCT00633880|O1|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1072446|NCT00633880|O2|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1072447|NCT00633880|O1|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1072448|NCT00633880|O2|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1072449|NCT00633880|O1|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1072450|NCT00633880|O2|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1072451|NCT00633880|O1|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1072452|NCT00633880|O2|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1072453|NCT00633880|O1|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1072454|NCT00633880|O2|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1072455|NCT00633880|O1|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1072456|NCT00633880|O2|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1072457|NCT00633880|O1|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1072458|NCT00633880|O2|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1072459|NCT00633880|O1|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1072460|NCT00633880|O2|Outcome|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1072461|NCT00633880|O1|Outcome|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1072462|NCT00633880|E3|Reported Event|Open Label Phase|All patient titrated on droxidopa during open-label phase
1072463|NCT00633880|E2|Reported Event|Placebo|"Double-blind~Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1072464|NCT00633880|E1|Reported Event|Droxidopa|"Double-blind~Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day"
1072465|NCT00633867|B3|Baseline|Total|Total of all reporting groups
1072466|NCT00633867|B2|Baseline|Macintosh|Tracheal intubation using Macintosh Laryngoscope
1072467|NCT00633867|B1|Baseline|McGrath|Tracheal Intubation using McGrath video-laryngoscope
1072468|NCT00633867|P2|Participant Flow|Macintosh|Tracheal intubation using Macintosh Laryngoscope
1072469|NCT00633867|P1|Participant Flow|McGrath|Tracheal Intubation using McGrath video-laryngoscope
1072470|NCT00633867|O2|Outcome|Macintosh|Tracheal intubation using Macintosh Laryngoscope
1072471|NCT00633867|O1|Outcome|McGrath|Tracheal Intubation using McGrath video-laryngoscope
1072472|NCT00633867|E2|Reported Event|Macintosh|Tracheal intubation using Macintosh Laryngoscope
1072473|NCT00633867|E1|Reported Event|McGrath|Tracheal Intubation using McGrath video-laryngoscope
1072474|NCT00633750|B1|Baseline|Tarceva|Tarceva given by mouth at a dose of 150 mg/day for 5-14 days. Participants are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.
1072475|NCT00633750|P1|Participant Flow|Tarceva|Tarceva given by mouth at a dose of 150 mg/day for 5-14 days. Participants are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.
1072476|NCT00633750|O1|Outcome|Tarceva|Following a pre-treatment core biopsy, participants are given Tarceva at a dose of 150 mg/day by mouth for 5-14 days. Within 24 hours of their last dose of Tarceva, participants have their blood drawn and then undergo surgical resection of their tumor.
1072477|NCT00633750|O1|Outcome|Tarceva|Following a pre-treatment core biopsy, participants are given Tarceva at a dose of 150 mg/day by mouth for 5-14 days. Within 24 hours of their last dose of Tarceva, participants undergo a post-treatment resection of their tumor.
1072478|NCT00633750|O1|Outcome|Tarceva|Following a pre-treatment core breast biopsy, participants are given Tarceva at a dose of 150 mg/day by mouth for 5-14 days. Within 24 hours of their last dose of Tarceva, participants undergo a post-treatment resection of their tumor.
1072479|NCT00633750|E1|Reported Event|Tarceva|Tarceva given by mouth at a dose of 150 mg/day for 5-14 days. Participants are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.
1072480|NCT00633594|B4|Baseline|Total|Total of all reporting groups
1072481|NCT00633594|B3|Baseline|Phase II - Lenalidomide 10mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1 14.
1072482|NCT00633594|B2|Baseline|Phase I - Lenalidomide 10mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1 14.
1072483|NCT00633594|B1|Baseline|Phase I - Lenalidomide 15mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 15 mg PO daily on Days 1 14. .
1072484|NCT00633594|P3|Participant Flow|Phase II - Lenalidomide 10mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
1072485|NCT00633594|P2|Participant Flow|Phase I - Lenalidomide 10mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
1072486|NCT00633594|P1|Participant Flow|Phase I - Lenalidomide 15mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 15 mg PO daily on Days 1-14.
1072535|NCT00633464|O1|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
1072536|NCT00633464|O2|Outcome|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
1072537|NCT00633464|O1|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
1072487|NCT00633594|O2|Outcome|Previously Untreated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who not received any previous treatment prior to initiating study treatment.~Includes 1 participant in Phase I - Lenalidomide15 mg PO QD, 7 participants in Phase I - Lenlidomide10 mg PO QD and 21 participants in Phase II - Lenalidomide 10 mg PO QD"
1072488|NCT00633594|O1|Outcome|Previously Treated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who were refractory to/relapsed from their previous treatment.~Includes 4 participants in Phase I - Lenalidomide15 mg PO QD, 1 participant in Phase I - Lenlidomide10 mg PO QD and 5 participants in Phase II - Lenalidomide 10 mg PO QD"
1072489|NCT00633594|O2|Outcome|Phase II Participants (10 mg Lenalidomide)|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
1072490|NCT00633594|O1|Outcome|Phase I Participants (10 mg/15 mg Lenalidomide)|"Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 or 15mg PO daily on Days 1-14.~Includes participants tested on two separate dose levels, 15 mg by mouth (PO) daily (5 participants) or 10 mg PO daily (8 participants)"
1072491|NCT00633594|O2|Outcome|Previously Untreated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who not received any previous treatment prior to initiating study treatment.~Includes 1 participant in Phase I - Lenalidomide15 mg PO QD, 7 participants in Phase I - Lenlidomide10 mg PO QD and 21 participants in Phase II - Lenalidomide 10 mg PO QD"
1072492|NCT00633594|O1|Outcome|Previously Treated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who were refractory to/relapsed from their previous treatment.~Includes 4 participants in Phase I - Lenalidomide15 mg PO QD, 1 participant in Phase I - Lenlidomide10 mg PO QD and 5 participants in Phase II - Lenalidomide 10 mg PO QD"
1072493|NCT00633594|O2|Outcome|Phase II Participants (10 mg Lenalidomide)|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
1072494|NCT00633594|O1|Outcome|Phase I Participants (10 mg/15 mg Lenalidomide)|"Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg PO daily on Days 1-14.~Includes participants tested on two separate dose levels, 15 mg by mouth (PO) daily (5 participants) or 10 mg PO daily (8 participants)"
1072495|NCT00633594|O2|Outcome|Previously Untreated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who not received any previous treatment prior to initiating study treatment.~Includes 1 participant in Phase I - Lenalidomide15 mg PO QD, 7 participants in Phase I - Lenlidomide10 mg PO QD and 21 participants in Phase II - Lenalidomide 10 mg PO QD"
1072496|NCT00633594|O1|Outcome|Previously Treated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who were refractory to/relapsed from their previous treatment.~Includes 4 participants in Phase I - Lenalidomide15 mg PO QD, 1 participant in Phase I - Lenlidomide10 mg PO QD and 5 participants in Phase II - Lenalidomide 10 mg PO QD"
1072497|NCT00633594|O2|Outcome|Phase II Participants (10 mg Lenalidomide)|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
1072498|NCT00633594|O1|Outcome|Phase I Participants (10 mg/15 mg Lenalidomide)|"Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 or 15mg PO daily on Days 1-14.~Includes participants tested on two separate dose levels, 15 mg by mouth (PO) daily (5 participants) or 10 mg PO daily (8 participants)"
1072499|NCT00633594|O2|Outcome|Previously Untreated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who not received any previous treatment prior to initiating study treatment.~Includes 1 participant in Phase I - Lenalidomide15 mg PO QD, 7 participants in Phase I - Lenlidomide10 mg PO QD and 21 participants in Phase II - Lenalidomide 10 mg PO QD"
1072500|NCT00633594|O1|Outcome|Previously Treated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who were refractory to/relapsed from their previous treatment.~Includes 4 participants in Phase I - Lenalidomide15 mg PO QD, 1 participant in Phase I - Lenlidomide10 mg PO QD and 5 participants in Phase II - Lenalidomide 10 mg PO QD"
1072501|NCT00633594|O2|Outcome|Phase II Participants (10 mg Lenalidomide)|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
1072502|NCT00633594|O1|Outcome|Phase I Participants (10 mg/15 mg Lenalidomide)|"Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg PO daily on Days 1-14.~Includes participants tested on two separate dose levels, 15 mg by mouth (PO) daily (5 participants) or 10 mg PO daily (8 participants)"
1072538|NCT00633464|O2|Outcome|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
1072539|NCT00633464|O1|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
1072503|NCT00633594|O2|Outcome|Previously Untreated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who not received any previous treatment prior to initiating study treatment.~Includes 1 participant in Phase I - Lenalidomide15 mg PO QD, 7 participants in Phase I - Lenlidomide10 mg PO QD and 21 participants in Phase II - Lenalidomide 10 mg PO QD"
1072504|NCT00633594|O1|Outcome|Previously Treated Participants|"The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who were refractory to/relapsed from their previous treatment.~Includes 4 participants in Phase I - Lenalidomide15 mg PO QD, 1 participant in Phase I - Lenlidomide10 mg PO QD and 5 participants in Phase II - Lenalidomide 10 mg PO QD"
1072505|NCT00633594|O2|Outcome|Phase II Participants (10 mg Lenalidomide)|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
1072506|NCT00633594|O1|Outcome|Phase I Participants (10 mg/15 mg Lenalidomide)|"Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg PO daily on Days 1-14.~Includes participants tested on two separate dose levels, 15 mg by mouth (PO) daily (5 participants) or 10 mg PO daily (8 participants)"
1072507|NCT00633594|O1|Outcome|Phase II - Lenalidomide 10mg PO QD|Lenalidomide DL-1 dose (10 mg orally, once daily (PO QD)) Day 1-14 followed by 7 days of rest, Rituximab 375 mg/m2 IV Days 1, 8, and 15 of Cycle 1; Cycles 2-6: 375 mg/m2 IV Day 1, Bortezomib 1.3 mg/m2 IV Days 1, 4, 8, and 11 for Cycles 1-6
1072508|NCT00633594|O1|Outcome|Phase I Participants (10 mg/15 mg Lenalidomide)|"Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg PO daily on Days 1-14.~Includes participants tested on two separate dose levels, 15 mg by mouth (PO) daily (5 participants) or 10 mg PO daily (8 participants)"
1072509|NCT00633594|E3|Reported Event|Phase II - Lenalidomide 10mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1 14.
1072510|NCT00633594|E2|Reported Event|Phase I - Lenalidomide 10mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1 14.
1072511|NCT00633594|E1|Reported Event|Phase I - Lenalidomide 15mg PO QD|Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 15 mg PO daily on Days 1 14.
1072512|NCT00633477|B3|Baseline|Total|Total of all reporting groups
1072513|NCT00633477|B2|Baseline|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
1072514|NCT00633477|B1|Baseline|Resatorvid 2.4 mg/kg/Day|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours
1072515|NCT00633477|P2|Participant Flow|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
1072516|NCT00633477|P1|Participant Flow|Resatorvid|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours.
1072517|NCT00633477|O2|Outcome|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
1072518|NCT00633477|O1|Outcome|Resatorvid|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours.
1072519|NCT00633477|O2|Outcome|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
1072520|NCT00633477|O1|Outcome|Resatorvid|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours.
1072521|NCT00633477|O2|Outcome|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
1072522|NCT00633477|O1|Outcome|Resatorvid|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours.
1072523|NCT00633477|O2|Outcome|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
1072524|NCT00633477|O1|Outcome|Resatorvid|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours.
1072525|NCT00633477|O2|Outcome|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
1072526|NCT00633477|O1|Outcome|Resatorvid|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours.
1072527|NCT00633477|E2|Reported Event|Placebo|Placebo given as a 30-minute loading dose followed by a continuous infusion for 96 hours.
1072528|NCT00633477|E1|Reported Event|Resatorvid|Resatorvid 1.2 mg/kg given as a 30-minute loading dose followed by 2.4 mg/kg/day given as a continuous infusion for 96 hours.
1072529|NCT00633464|B3|Baseline|Total|Total of all reporting groups
1072530|NCT00633464|B2|Baseline|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
1072531|NCT00633464|B1|Baseline|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
1072532|NCT00633464|P2|Participant Flow|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
1072533|NCT00633464|P1|Participant Flow|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
1072534|NCT00633464|O2|Outcome|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
1072540|NCT00633464|O2|Outcome|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
1072541|NCT00633464|O1|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
1072542|NCT00633464|O2|Outcome|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
1072543|NCT00633464|O1|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
1072544|NCT00633464|O2|Outcome|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
1072545|NCT00633464|O1|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
1072546|NCT00633464|O2|Outcome|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
1072547|NCT00633464|O1|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
1072548|NCT00633464|O2|Outcome|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
1072549|NCT00633464|O1|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
1072550|NCT00633464|E2|Reported Event|Cetuximab 250 mg/m^2 + Ixabepilone 40 mg/m^2|cetuximab 400 mg/m^2 loading dose then 250 mg/m^2 weekly + ixabepilone 40 mg/m^2 every 3 weeks
1072551|NCT00633464|E1|Reported Event|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
1072552|NCT00633399|B3|Baseline|Total|Total of all reporting groups
1072553|NCT00633399|B2|Baseline|Placebo + Escitalopram|"Patients in group 2 will receive Placebo added to Escitalopram for the full 8 weeks of Phase 2.~Placebo: 0mg Placebo per day (1-4 tablets per day). Dose increases and dose decreases may occur, but patient will remain at 0mg placebo."
1072554|NCT00633399|B1|Baseline|Ziprasidone + Escitalopram|"Patients in group 1 will receive Ziprasidone added to Escitalopram for the full 8 weeks of Phase 2.~Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient."
1072555|NCT00633399|P2|Participant Flow|Placebo + Escitalopram|"Patients in group 2 will receive Placebo added to Escitalopram for the full 8 weeks of Phase 2.~Placebo: 0mg Placebo per day (1-4 tablets per day). Dose increases and dose decreases may occur, but patient will remain at 0mg placebo."
1072556|NCT00633399|P1|Participant Flow|Ziprasidone + Escitalopram|"Patients in group 1 will receive Ziprasidone added to Escitalopram for the full 8 weeks of Phase 2.~Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient."
1072557|NCT00633399|O2|Outcome|Placebo + Escitalopram|"Patients in group 2 will receive Placebo added to Escitalopram for the full 8 weeks of Phase 2.~Placebo: 0mg Placebo per day (1-4 tablets per day). Dose increases and dose decreases may occur, but patient will remain at 0mg placebo."
1072558|NCT00633399|O1|Outcome|Ziprasidone + Escitalopram|"Patients in group 1 will receive Ziprasidone added to Escitalopram for the full 8 weeks of Phase 2.~Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient."
1072559|NCT00633399|O2|Outcome|Placebo + Escitalopram|"Patients in group 2 will receive Placebo added to Escitalopram for the full 8 weeks of Phase 2.~Placebo: 0mg Placebo per day (1-4 tablets per day). Dose increases and dose decreases may occur, but patient will remain at 0mg placebo."
1072560|NCT00633399|O1|Outcome|Ziprasidone + Escitalopram|"Patients in group 1 will receive Ziprasidone added to Escitalopram for the full 8 weeks of Phase 2.~Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient."
1072561|NCT00633399|O2|Outcome|Placebo + Escitalopram|"Patients in group 2 will receive Placebo added to Escitalopram for the full 8 weeks of Phase 2.~Placebo: 0mg Placebo per day (1-4 tablets per day). Dose increases and dose decreases may occur, but patient will remain at 0mg placebo."
1072562|NCT00633399|O1|Outcome|Ziprasidone + Escitalopram|"Patients in group 1 will receive Ziprasidone added to Escitalopram for the full 8 weeks of Phase 2.~Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient."
1072563|NCT00633399|E2|Reported Event|Ziprasidone + Placebo|"Patients in group 2 will receive Placebo for the full 8 weeks of Phase 2.~Placebo: 0mg Placebo per day (1-4 tablets per day). Dose increases and dose decreases may occur, but patient will remain at 0mg placebo."
1072564|NCT00633399|E1|Reported Event|Ziprasidone + Escitalpram|"Patients in group 1 will receive Ziprasidone for the full 8 weeks of Phase 2.~Ziprasidone: 20mg-80mg a day. Dose increases of 20mg per day may occur at three study visits as directed by clinician. Maximum; 80mg per day per patient."
1072565|NCT00633139|B4|Baseline|Total|Total of all reporting groups
1072566|NCT00633139|B3|Baseline|Cohort 3|Participants received a repeated dose of rhASA at 200 U/kg IV infusion over 60 minutes was administered every other week up to Week 52.
1072567|NCT00633139|B2|Baseline|Cohort 2|Participants received a repeated dose of rhASA at 100 U/kg IV infusion over 30 minutes was administered every other week up to Week 52.
1072568|NCT00633139|B1|Baseline|Cohort 1|Participants received a single dose of rhASA at 25 U/kg IV infusion in rhASA-01 (NCT00418561) study. Thereafter a repeated dose of rhASA at 50 U/kg, over 30 minutes was administered every other week up to Week 52.
1072569|NCT00633139|P3|Participant Flow|Cohort 3|Participants received a repeated dose of rhASA at 200 U/kg IV infusion over 60 minutes was administered every other week up to Week 52.
1072570|NCT00633139|P2|Participant Flow|Cohort 2|Participants received a repeated dose of rhASA at 100 U/kg IV infusion over 30 minutes was administered every other week up to Week 52.
1072571|NCT00633139|P1|Participant Flow|Cohort 1|Participants received a single dose of rhASA at 25 units per kilogram (U/kg) intravenous (IV) infusion in rhASA-01 (NCT00418561) study. Thereafter a repeated dose of rhASA at 50 U/kg, over 30 minutes was administered every other week up to Week 52.
1072572|NCT00633139|O3|Outcome|Cohort 3|Participants received a repeated dose of rhASA at 200 U/kg IV infusion over 60 minutes was administered every other week up to Week 52.
1072573|NCT00633139|O2|Outcome|Cohort 2|Participants received a repeated dose of rhASA at 100 U/kg IV infusion over 30 minutes was administered every other week up to Week 52.
1072655|NCT00632931|O2|Outcome|Placebo|
1072656|NCT00632931|O1|Outcome|Vorinostat|
1072574|NCT00633139|O1|Outcome|Cohort 1|Participants received a single dose of rhASA at 25 U/kg IV infusion in rhASA-01 (NCT00418561) study. Thereafter a repeated dose of rhASA at 50 U/kg, over 30 minutes was administered every other week up to Week 52.
1072575|NCT00633139|O3|Outcome|Cohort 3|Participants received a repeated dose of rhASA at 200 U/kg IV infusion over 60 minutes was administered every other week up to Week 52.
1072576|NCT00633139|O2|Outcome|Cohort 2|Participants received a repeated dose of rhASA at 100 U/kg IV infusion over 30 minutes was administered every other week up to Week 52.
1072577|NCT00633139|O1|Outcome|Cohort 1|Participants received a single dose of rhASA at 25 U/kg IV infusion in rhASA-01 (NCT00418561) study. Thereafter a repeated dose of rhASA at 50 U/kg, over 30 minutes was administered every other week up to Week 52.
1072578|NCT00633139|O3|Outcome|Cohort 3|Participants received a repeated dose of rhASA at 200 U/kg IV infusion over 60 minutes was administered every other week up to Week 52.
1072579|NCT00633139|O2|Outcome|Cohort 2|Participants received a repeated dose of rhASA at 100 U/kg IV infusion over 30 minutes was administered every other week up to Week 52.
1072580|NCT00633139|O1|Outcome|Cohort 1|Participants received a single dose of rhASA at 25 U/kg IV infusion in rhASA-01 (NCT00418561) study. Thereafter a repeated dose of rhASA at 50 U/kg, over 30 minutes was administered every other week up to Week 52.
1072581|NCT00633139|E3|Reported Event|Cohort 3|Cohort 3: Participants received a repeated dose of rhASA at 200 U/kg IV infusion over 60 minutes was administered every other week up to Week 52.
1072582|NCT00633139|E2|Reported Event|Cohort 2|Cohort 2: Participants received a repeated dose of rhASA at 100 U/kg IV infusion over 30 minutes was administered every other week up to Week 52.
1072583|NCT00633139|E1|Reported Event|Cohort 1|Cohort 1: Participants received a single dose of rhASA at 25 U/kg IV infusion in rhASA-01 (NCT00418561) study. Thereafter a repeated dose of rhASA at 50 U/kg, over 30 minutes was administered every other week up to Week 52.
1072584|NCT00633126|B1|Baseline|Ceftaroline|Single group assignment, single dose of 600mg ceftaroline administered intravenously.
1072585|NCT00633126|P1|Participant Flow|Ceftaroline|Single group assignment, single dose of 600mg ceftaroline administered intravenously.
1072586|NCT00633126|O1|Outcome|Ceftaroline|Single group assignment, single dose of 600mg ceftaroline administered intravenously.
1072587|NCT00633126|O1|Outcome|Ceftaroline|Single group assignment, single dose of 600mg ceftaroline administered intravenously.
1072588|NCT00633126|E1|Reported Event|Ceftaroline|Single group assignment, single dose of 600mg ceftaroline administered intravenously.
1072589|NCT00633087|B1|Baseline|2-deoxyglucose|2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
1072590|NCT00633087|P1|Participant Flow|2-deoxyglucose|2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
1072591|NCT00633087|O1|Outcome|2-deoxyglucose|2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
1072592|NCT00633087|O1|Outcome|2-deoxyglucose|2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
1072593|NCT00633087|O1|Outcome|2-deoxyglucose|2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
1072594|NCT00633087|O1|Outcome|2-deoxyglucose|2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
1072595|NCT00633087|E1|Reported Event|2-deoxyglucose|2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.
1072596|NCT00633074|B3|Baseline|Total|Total of all reporting groups
1072597|NCT00633074|B2|Baseline|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
1072598|NCT00633074|B1|Baseline|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
1072599|NCT00633074|P2|Participant Flow|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
1072600|NCT00633074|P1|Participant Flow|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
1072601|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
1072602|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
1072603|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
1072604|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
1072605|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
1072606|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
1072607|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
1072608|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
1072609|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
1072610|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
1072611|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
1072612|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
1072613|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
1072657|NCT00632931|O2|Outcome|Placebo|
1072658|NCT00632931|O1|Outcome|Vorinostat|
1072614|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
1072615|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
1072616|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
1072617|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
1072618|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
1072619|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
1072620|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
1072621|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
1072622|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
1072623|NCT00633074|O2|Outcome|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
1072624|NCT00633074|O1|Outcome|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
1072625|NCT00633074|E2|Reported Event|Thiomersal Reduced FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
1072626|NCT00633074|E1|Reported Event|Thiomersal-free FluAS25 Adjuvanted Vaccine Group|Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
1072627|NCT00633009|B4|Baseline|Total|Total of all reporting groups
1072628|NCT00633009|B3|Baseline|50 ug Study Group|Naive volunteers tested with 50 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
1072629|NCT00633009|B2|Baseline|30 ug Study Group|Naive volunteers tested with 30 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
1072630|NCT00633009|B1|Baseline|15 ug Study Group|Naive volunteers tested with 15 ug injection of LtSTA. Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
1072631|NCT00633009|P3|Participant Flow|50 ug Study Group|Naive volunteers tested with 50 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.All participants received a placebo skin test concurrently with active drug.
1072632|NCT00633009|P2|Participant Flow|30 ug Study Group|Naive volunteers tested with 30 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.All participants received a placebo skin test concurrently with active drug.
1072633|NCT00633009|P1|Participant Flow|15 ug Study Group|Naive volunteers tested with 15 ug injection of LtSTA. Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10. All participants received a placebo skin test concurrently with active drug.
1072634|NCT00633009|O3|Outcome|50 ug Study Group|Naive volunteers tested with 50 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
1072635|NCT00633009|O2|Outcome|30 ug Study Group|Naive volunteers tested with 30 ug injection of LtSTA.Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
1072636|NCT00633009|O1|Outcome|15 ug Study Group|Naive volunteers tested with 15 ug injection of LtSTA. Participants were skin tested on visits 3, 6 and 9 of the study. The results of the skin tests were read after 48 hours (+/- 6 hours) on visits 4, 7 and 10. A final evaluation was performed on visit 11, fourteen days after visit 10.
1072637|NCT00633009|O3|Outcome|50 ug Study Group|
1072638|NCT00633009|O2|Outcome|30 ug Study Group|
1072639|NCT00633009|O1|Outcome|15 ug Study Group|
1072640|NCT00633009|E3|Reported Event|50 ug Study Group|
1072641|NCT00633009|E2|Reported Event|30 ug Study Group|
1072642|NCT00633009|E1|Reported Event|15 ug Study Group|
1072643|NCT00632931|B1|Baseline|All Participants|All Participants group includes data from all participants throughout Part 1 and Part 2 of the study.
1072644|NCT00632931|P3|Participant Flow|All Participants: Part 2|"Vorinostat 400 mg once daily.~Ten participants changed dosage to vorinostat 300 mg daily during Part 2."
1072645|NCT00632931|P2|Participant Flow|Placebo Then Vorinostat: Part 1|Single dose matching placebo in Period 1 followed by a three day wash out period, then single dose 800 mg vorinostat in Period 2. Following the last dose of study drug, there was a minimum 5 day washout before entering Part 2.
1072646|NCT00632931|P1|Participant Flow|Vorinostat Then Placebo: Part 1|Single dose 800 mg vorinostat in Period 1 followed by a three day wash out period, then matching placebo in Period 2. Following the last dose of study drug, there was a minimum 5 day washout before entering Part 2.
1072647|NCT00632931|O2|Outcome|Placebo|
1072648|NCT00632931|O1|Outcome|Vorinostat|
1072649|NCT00632931|O2|Outcome|Placebo|
1072650|NCT00632931|O1|Outcome|Vorinostat|
1072651|NCT00632931|O2|Outcome|Placebo|
1072652|NCT00632931|O1|Outcome|Vorinostat|
1072653|NCT00632931|O2|Outcome|Placebo|
1072654|NCT00632931|O1|Outcome|Vorinostat|
1072663|NCT00632931|E1|Reported Event|All Participants|All Participants group includes data from all participants throughout Part 1 and Part 2 of the study.
1072664|NCT00632814|B4|Baseline|Total|Total of all reporting groups
1072665|NCT00632814|B3|Baseline|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
1072666|NCT00632814|B2|Baseline|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
1072667|NCT00632814|B1|Baseline|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
1072668|NCT00632814|P3|Participant Flow|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
1072669|NCT00632814|P2|Participant Flow|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
1072670|NCT00632814|P1|Participant Flow|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
1072671|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
1072672|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
1072673|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
1072674|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
1072675|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
1072676|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
1072677|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
1072678|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
1072679|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
1072680|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
1072681|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
1072682|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
1072683|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
1072684|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
1073076|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
1072685|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
1072686|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
1072687|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
1072688|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
1072689|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
1072690|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
1072691|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
1072692|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
1072693|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
1072694|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
1072695|NCT00632814|O3|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
1072696|NCT00632814|O2|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
1072697|NCT00632814|O1|Outcome|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
1072698|NCT00632814|E3|Reported Event|rFVIII-FS (Kogenate FS, BAY14-2222), Tiw (3 x 25 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months. No escalation opportunity for participants in this group
1072699|NCT00632814|E2|Reported Event|rFVIII-FS (Kogenate FS, BAY14-2222), Biw (30 IU/kg + 40 IU/kg)|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
1072700|NCT00632814|E1|Reported Event|rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw|rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
1072701|NCT00632749|B15|Baseline|Total|Total of all reporting groups
1072702|NCT00632749|B14|Baseline|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072703|NCT00632749|B13|Baseline|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072704|NCT00632749|B12|Baseline|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072705|NCT00632749|B11|Baseline|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072706|NCT00632749|B10|Baseline|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072707|NCT00632749|B9|Baseline|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072708|NCT00632749|B8|Baseline|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072709|NCT00632749|B7|Baseline|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072710|NCT00632749|B6|Baseline|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072711|NCT00632749|B5|Baseline|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072712|NCT00632749|B4|Baseline|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072713|NCT00632749|B3|Baseline|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072714|NCT00632749|B2|Baseline|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072715|NCT00632749|B1|Baseline|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072716|NCT00632749|P14|Participant Flow|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072717|NCT00632749|P13|Participant Flow|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072718|NCT00632749|P12|Participant Flow|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072719|NCT00632749|P11|Participant Flow|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072720|NCT00632749|P10|Participant Flow|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072721|NCT00632749|P9|Participant Flow|80 mg BI 811283+ 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072722|NCT00632749|P8|Participant Flow|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1073029|NCT00632632|B1|Baseline|D-Cycloserine (DCS)|D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
1073077|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
1072723|NCT00632749|P7|Participant Flow|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072724|NCT00632749|P6|Participant Flow|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072725|NCT00632749|P5|Participant Flow|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072726|NCT00632749|P4|Participant Flow|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072727|NCT00632749|P3|Participant Flow|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072728|NCT00632749|P2|Participant Flow|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072729|NCT00632749|P1|Participant Flow|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072730|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072731|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072732|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072733|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072734|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072735|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072736|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072737|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072738|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072739|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1073030|NCT00632632|P2|Participant Flow|Placebo|placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
1073078|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
1072740|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072741|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072742|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072743|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072744|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072745|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072746|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072747|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072748|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072749|NCT00632749|O9|Outcome|80 mg BI 811283 +20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072750|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072751|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072752|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072753|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072754|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072755|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072756|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072757|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072758|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072759|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072760|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072761|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072762|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072763|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072764|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072765|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072766|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072767|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072768|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072769|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072770|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072771|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072772|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072773|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072774|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072775|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072776|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072777|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072778|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072779|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072780|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072781|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072782|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072783|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072784|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072785|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072786|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072787|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072788|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072789|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072790|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072791|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072792|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072793|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072794|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072795|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072796|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072797|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072798|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072799|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072800|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072801|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072802|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072803|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072804|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072805|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072806|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072807|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072808|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072809|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072810|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072811|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072812|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072813|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072814|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072815|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072816|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072817|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072818|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072819|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072820|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072821|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072822|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072823|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072824|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072825|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072826|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072827|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072828|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072829|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072830|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072831|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072832|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072833|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072834|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072835|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072836|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072837|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072838|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072839|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072840|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072841|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072842|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072843|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072844|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072845|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072846|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072847|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072848|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072849|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072850|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072851|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072852|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072853|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072854|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072855|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072856|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072857|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072858|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072859|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072860|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072861|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072862|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072863|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072864|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072865|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072866|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072867|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072868|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072869|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072870|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072871|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072872|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072873|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072874|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072875|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072876|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072877|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072878|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072879|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072880|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072881|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072882|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072883|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072884|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072885|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072886|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072887|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072888|NCT00632749|O6|Outcome|120mg (BI 811283+ Cytarabine)- Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072889|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072890|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072891|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine- Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072892|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072893|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072894|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072895|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072896|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072897|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072898|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072899|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072900|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072901|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072902|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072903|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072904|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072905|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072906|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072907|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072908|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072909|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072910|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072911|NCT00632749|O11|Outcome|240 mg BI 811283+ 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072912|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072913|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072914|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072915|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072916|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072917|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072918|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072919|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072920|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072921|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072922|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072923|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072924|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072925|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072926|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072927|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072928|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072929|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072930|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072931|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072932|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072933|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072934|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072935|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072936|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072937|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072938|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072939|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072940|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072941|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072942|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072943|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072944|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072945|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072946|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072947|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072948|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072949|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072950|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072951|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072952|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072953|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072954|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072955|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072956|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072957|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072958|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072959|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072960|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072961|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072962|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072963|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072964|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072965|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072966|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072967|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072968|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072969|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072970|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072971|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072972|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072973|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072974|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072975|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072976|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072977|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072978|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072979|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072980|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072981|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072982|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072983|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072984|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072985|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072986|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072987|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072988|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072989|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072990|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072991|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072992|NCT00632749|O14|Outcome|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072993|NCT00632749|O13|Outcome|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072994|NCT00632749|O12|Outcome|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072995|NCT00632749|O11|Outcome|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072996|NCT00632749|O10|Outcome|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072997|NCT00632749|O9|Outcome|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072998|NCT00632749|O8|Outcome|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1072999|NCT00632749|O7|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1073000|NCT00632749|O6|Outcome|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1073001|NCT00632749|O5|Outcome|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1073002|NCT00632749|O4|Outcome|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1073003|NCT00632749|O3|Outcome|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1073004|NCT00632749|O2|Outcome|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1073005|NCT00632749|O1|Outcome|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1073006|NCT00632749|O2|Outcome|Treatment Schedule B|"Subjects received BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle).~BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection).~The starting dose for BI 811283 was 5 mg, with dose levels of 5, 40, 80, 160, 240, 300, 360 and 420 mg being used in Schedule B.~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1073007|NCT00632749|O1|Outcome|Treatment Schedule A|"Subjects received BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle).~BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection).~The starting dose for BI 811283 was 5 mg, with dose levels of 5, 15, 30, 60, 100 and 120 mg used in Schedule A.~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1073008|NCT00632749|E14|Reported Event|420 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"420 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1073031|NCT00632632|P1|Participant Flow|D-Cycloserine (DCS)|D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
1073009|NCT00632749|E13|Reported Event|360 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"360 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1073010|NCT00632749|E12|Reported Event|300 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"300 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1073011|NCT00632749|E11|Reported Event|240 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"240 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1073012|NCT00632749|E10|Reported Event|160 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"160 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1073013|NCT00632749|E9|Reported Event|80 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"80 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1073014|NCT00632749|E8|Reported Event|40 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"40 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1073015|NCT00632749|E7|Reported Event|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule B|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment schedule B: BI 811283 on Day 1 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1073016|NCT00632749|E6|Reported Event|120 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"120 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1073017|NCT00632749|E5|Reported Event|100 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"100 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1073018|NCT00632749|E4|Reported Event|60 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"60 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1073019|NCT00632749|E3|Reported Event|30 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"30 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1073020|NCT00632749|E2|Reported Event|15 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"15 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1073021|NCT00632749|E1|Reported Event|5 mg BI 811283 + 20 mg Cytarabine - Treatment Schedule A|"5 mg of BI 811283 (preconcentrate for infusion after dilution) in combination with cytarabine (solution for injection);~Treatment Schedule A: BI 811283 on Days 1 + 15 in combination with cytarabine 20 mg twice daily on Days 1-10 (28-day cycle);~BI 811283: 24-hour continuous intravenous infusion Cytarabine: subcutaneous injection"
1073022|NCT00632736|B1|Baseline|Ropinirole XL|Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study.
1073023|NCT00632736|P1|Participant Flow|Ropinirole XL|Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study.
1073024|NCT00632736|O1|Outcome|Ropinirole XL|Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study.
1073025|NCT00632736|O1|Outcome|Ropinirole XL|Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study.
1073026|NCT00632736|E1|Reported Event|Ropinirole XL|Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study.
1073027|NCT00632632|B3|Baseline|Total|Total of all reporting groups
1073028|NCT00632632|B2|Baseline|Placebo|placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
1073073|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
1073032|NCT00632632|O2|Outcome|Placebo|placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
1073033|NCT00632632|O1|Outcome|D-Cycloserine (DCS)|D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
1073034|NCT00632632|O2|Outcome|Placebo|placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
1073035|NCT00632632|O1|Outcome|D-Cycloserine (DCS)|D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
1073036|NCT00632632|O2|Outcome|Placebo|placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
1073037|NCT00632632|O1|Outcome|D-Cycloserine (DCS)|D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
1073038|NCT00632632|E2|Reported Event|Placebo|placebo: Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).
1073039|NCT00632632|E1|Reported Event|D-Cycloserine (DCS)|D-Cycloserine: CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
1073040|NCT00632619|B3|Baseline|Total|Total of all reporting groups
1073041|NCT00632619|B2|Baseline|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
1073042|NCT00632619|B1|Baseline|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
1073043|NCT00632619|P2|Participant Flow|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
1073044|NCT00632619|P1|Participant Flow|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
1073045|NCT00632619|O2|Outcome|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
1073046|NCT00632619|O1|Outcome|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
1073047|NCT00632619|O2|Outcome|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
1073048|NCT00632619|O1|Outcome|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
1073074|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
1073075|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
1073049|NCT00632619|O2|Outcome|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
1073050|NCT00632619|O1|Outcome|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
1073051|NCT00632619|O2|Outcome|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
1073052|NCT00632619|O1|Outcome|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
1073053|NCT00632619|O2|Outcome|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
1073054|NCT00632619|O1|Outcome|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
1073055|NCT00632619|E2|Reported Event|Medication and Novel Therapy Group|"Participants will receive stimulant medication therapy and group-based behavior therapy.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Group-based behavior therapy : Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems."
1073056|NCT00632619|E1|Reported Event|Medication and Community Treatment Group|"Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.~Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.~Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression."
1073057|NCT00632541|B1|Baseline|Single Arm A|Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week, 1 Cycle = 4 weeks. Imaging every third cycle
1073058|NCT00632541|P1|Participant Flow|Single Arm A|Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week. 1 Cycle = 4 weeks. Imaging every third cycle.
1073059|NCT00632541|O1|Outcome|Single Arm A|"Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week, 1 Cycle = 4 weeks. Imaging every third cycle~Sorafenib: Sorafenib 200mg po daily~Bevacizumab: Bevacizumab 5mg/kg every other week~1 Cycle = 4 weeks~Imaging: Imaging every third cycle"
1073060|NCT00632541|E1|Reported Event|Single Arm A|Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week, 1 Cycle = 4 weeks. Imaging every third cycle
1073061|NCT00632502|B3|Baseline|Total|Total of all reporting groups
1073062|NCT00632502|B2|Baseline|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
1073063|NCT00632502|B1|Baseline|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
1073064|NCT00632502|P2|Participant Flow|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
1073065|NCT00632502|P1|Participant Flow|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
1073066|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
1073067|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
1073068|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
1073069|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
1073070|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
1073071|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
1073072|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
1073079|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
1073080|NCT00632502|O1|Outcome|Navarixin|Navarixin (SCH 537123) 30 mg capsule to be taken by mouth once daily for 4 weeks
1073081|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
1073082|NCT00632502|O1|Outcome|Navarixin|Navarixin (SCH 537123) 30 mg capsule to be taken by mouth once daily for 4 weeks
1073083|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
1073084|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
1073085|NCT00632502|O2|Outcome|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
1073086|NCT00632502|O1|Outcome|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
1073087|NCT00632502|E2|Reported Event|Placebo|Placebo capsule to be taken by mouth once daily for 4 weeks
1073088|NCT00632502|E1|Reported Event|Navarixin|Navarixin 30 mg capsule to be taken by mouth once daily for 4 weeks
1073089|NCT00632489|B4|Baseline|Total|Total of all reporting groups
1073090|NCT00632489|B3|Baseline|LBH589, Capecitabine and Lapatinib|"LBH589, Capecitabine and Lapatinib (Breast Cancer Patients)~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
1073091|NCT00632489|B2|Baseline|LBH589 and Lapatinib|"LBH589 and Lapatinib~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
1073092|NCT00632489|B1|Baseline|LBH589 With Capecitabine|"MTD, LBH589 with Capecitabine~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days."
1073093|NCT00632489|P3|Participant Flow|LBH589, Capecitabine and Lapatinib|"LBH589, Capecitabine and Lapatinib (Breast Cancer Patients)~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
1073094|NCT00632489|P2|Participant Flow|LBH589 and Lapatinib|"LBH589 and Lapatinib~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
1073095|NCT00632489|P1|Participant Flow|LBH589 With Capecitabine|"MTD, LBH589 with Capecitabine~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days."
1073096|NCT00632489|O3|Outcome|LBH589, Capecitabine and Lapatinib|"LBH589, Capecitabine and Lapatinib (Breast Cancer Patients)~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
1073097|NCT00632489|O2|Outcome|LBH589 and Lapatinib|"LBH589 and Lapatinib~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
1073098|NCT00632489|O1|Outcome|LBH589 With Capecitabine|"MTD, LBH589 with Capecitabine~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days."
1073099|NCT00632489|O3|Outcome|LBH589, Capecitabine and Lapatinib|"LBH589, Capecitabine and Lapatinib (Breast Cancer Patients)~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
1073100|NCT00632489|O2|Outcome|LBH589 and Lapatinib|"LBH589 and Lapatinib~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
1073101|NCT00632489|O1|Outcome|LBH589 With Capecitabine|"MTD, LBH589 with Capecitabine~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days."
1073102|NCT00632489|E3|Reported Event|LBH589, Capecitabine and Lapatinib|"LBH589, Capecitabine and Lapatinib (Breast Cancer Patients)~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
1073103|NCT00632489|E2|Reported Event|LBH589 and Lapatinib|"LBH589 and Lapatinib~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination."
1073104|NCT00632489|E1|Reported Event|LBH589 With Capecitabine|"MTD, LBH589 with Capecitabine~LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.~Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days."
1073105|NCT00632463|B4|Baseline|Total|Total of all reporting groups
1073106|NCT00632463|B3|Baseline|3 (Placebo)|Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
1073107|NCT00632463|B2|Baseline|2 (Low Dose)|Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
1073108|NCT00632463|B1|Baseline|1 (High Dose)|Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
1073109|NCT00632463|P3|Participant Flow|3 (Placebo)|Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
1073110|NCT00632463|P2|Participant Flow|2 (Low Dose)|Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
1073111|NCT00632463|P1|Participant Flow|1 (High Dose)|Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
1073112|NCT00632463|O3|Outcome|3 (Placebo)|Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
1073113|NCT00632463|O2|Outcome|2 (Low Dose)|Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
1073114|NCT00632463|O1|Outcome|1 (High Dose)|Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
1073115|NCT00632463|O3|Outcome|3 (Placebo)|Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
1073116|NCT00632463|O2|Outcome|2 (Low Dose)|Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
1073117|NCT00632463|O1|Outcome|1 (High Dose)|Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
1073118|NCT00632463|O3|Outcome|3 (Placebo)|Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
1073119|NCT00632463|O2|Outcome|2 (Low Dose)|Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
1073120|NCT00632463|O1|Outcome|1 (High Dose)|Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
1073121|NCT00632463|E3|Reported Event|3 (Placebo)|Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
1073122|NCT00632463|E2|Reported Event|2 (Low Dose)|Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
1073123|NCT00632463|E1|Reported Event|1 (High Dose)|Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
1073124|NCT00632424|B4|Baseline|Total|Total of all reporting groups
1073125|NCT00632424|B3|Baseline|Ixabepilone 150 mg/Day|Participants received 50 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (50 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 150 mg per cycle.
1073126|NCT00632424|B2|Baseline|Ixabepilone 120 mg/Day|Participants received 40 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (40 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 120 mg per cycle.
1073127|NCT00632424|B1|Baseline|Ixabepilone 90 mg/Day|The starting dose level was 30 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (30 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 90 mg per cycle.
1073128|NCT00632424|P1|Participant Flow|All Treated Participants|Ixabepilone was given as 3 oral doses separated by 6 hours at 30 mg, 40 mg, or 50 mg doses every 6 hours for 3 total doses on Day 1 of a 21-day cycle.
1073129|NCT00632424|O3|Outcome|Ixabepilone 50 mg/Dose|Participants received 50 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (50 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 150 mg per cycle.
1073130|NCT00632424|O2|Outcome|Ixabepilone 40 mg/Dose|Participants received 40 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (40 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 120 mg per cycle.
1073161|NCT00632281|O1|Outcome|All Patients Receiving SBRT to the Thorax|
1073131|NCT00632424|O1|Outcome|Ixabepilone 30 mg/Dose|The starting dose level was 30 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (30 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 90 mg per cycle.
1073132|NCT00632424|O3|Outcome|Ixabepilone 150 mg/Day|Participants received 50 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (50 mg every 6 hours for 3 doses on Day 1 of a 21-day cycle for a total dose of 150 mg per cycle.
1073133|NCT00632424|O2|Outcome|Ixabepilone 120 mg/Day|Participants received 40 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (40 mg every 6 hours for 3 doses on Day 1 of a 21-day cycle for a total dose of 120 mg per cycle.
1073134|NCT00632424|O1|Outcome|Ixabepilone 90 mg/Day|The starting dose level was 30 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (30 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 90 mg per cycle.
1073135|NCT00632424|O3|Outcome|Ixabepilone 50 mg/Dose|Participants received 50 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (50 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 150 mg per cycle.
1073136|NCT00632424|O2|Outcome|Ixabepilone 40 mg/Dose|Participants received 40 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (40 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 120 mg per cycle.
1073137|NCT00632424|O1|Outcome|Ixabepilone 30 mg/Dose|The starting dose level was 30 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (30 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 90 mg per cycle.
1073138|NCT00632424|O1|Outcome|All Treated Participants|Ixabepilone was given as 3 oral doses separated by 6 hours at 30 mg, 40 mg, or 50 mg doses every 6 hours for 3 total doses on Day 1 of a 21-day cycle
1073139|NCT00632424|O1|Outcome|All Treated Participants|Ixabepilone was given as 3 oral doses separated by 6 hours at 30 mg, 40 mg, or 50 mg doses every 6 hours for 3 total doses on Day 1 of a 21-day cycle
1073140|NCT00632424|O1|Outcome|All Treated Participants|Ixabepilone was given as 3 oral doses separated by 6 hours at 30 mg, 40 mg, or 50 mg doses every 6 hours for 3 total doses on Day 1 of a 21-day cycle
1073141|NCT00632424|O1|Outcome|All Treated Participants|Ixabepilone was given as 3 oral doses separated by 6 hours at 30 mg, 40 mg, or 50 mg doses every 6 hours for 3 total doses on Day 1 of a 21-day cycle
1073142|NCT00632424|O1|Outcome|All Treated Participants|Ixabepilone was given as 3 oral doses separated by 6 hours at 30 mg, 40 mg, or 50 mg doses every 6 hours for 3 total doses on Day 1 of a 21-day cycle
1073143|NCT00632424|O3|Outcome|Ixabepilone 150 mg/Day|Participants received 50 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (50 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 150 mg per cycle.
1073144|NCT00632424|O2|Outcome|Ixabepilone 120 mg/Day|Participants received 40 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (40 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 120 mg per cycle.
1073145|NCT00632424|O1|Outcome|Ixabepilone 90 mg/Day|The starting dose level was 30 mg/dose for ixabepilone given as 3 oral doses separated by 6 hours (30 mg every 6 hours for 3 doses) on Day 1 of a 21-day cycle for a total dose of 90 mg per cycle.
1073146|NCT00632424|E3|Reported Event|Ixa 150 mg/Day|
1073147|NCT00632424|E2|Reported Event|Ixa 120 mg/Day|
1073148|NCT00632424|E1|Reported Event|Ixa 90 mg/Day|
1073149|NCT00632411|B3|Baseline|Total|Total of all reporting groups
1073150|NCT00632411|B2|Baseline|Reactive Group|"Participant will contact the research study staff to initiate sessions.~2 weeks of Nicotine Replacement Therapy in the form of patch will be distributed this group.~Six sessions will be delivered to the participant as long as the participant calls to initiate the sessions.~Phone session 1 will focus on smoking reduction.~Phone session 2 will focus on preparing to quit and surviving the first days as a non-smoker. A quit date will be set in 7 to 10 days.~Phone session 3 will focus on the first days after the quit date.~Phone session 4 will focus on a review of progress and challenges of quitting. Plans to manage high-risk situations will be discussed.~Phone session 5 will focus on short-term relapse prevention.~Phone session 6 will focus on long-term relapse prevention."
1073151|NCT00632411|B1|Baseline|Proactive Group|"Research study staff will contact participant to initiate sessions.~8 weeks of Nicotine Replacement Therapy in the form of patch will be distributed this group.~Six sessions will be proactively delivered to the participant.~Phone session 1 will focus on smoking reduction.~Phone session 2 will focus on preparing to quit and surviving the first days as a non-smoker. A quit date will be set in 7 to 10 days.~Phone session 3 will focus on the first days after the quit date.~Phone session 4 will focus on a review of progress and challenges of quitting. Plans to manage high-risk situations will be discussed.~Phone session 5 will focus on short-term relapse prevention.~Phone session 6 will focus on long-term relapse prevention."
1073152|NCT00632411|P2|Participant Flow|Reactive Group|"Participant will initiate contact with participant to conduct 6 individual counseling sessions.~Participants will receive 2 weeks of Nicotine Replacement Therapy in the form of a patch."
1073153|NCT00632411|P1|Participant Flow|Proactive Group|"Study staff will initiate contact to conduct 6 individual counseling sessions.~Participants will receive 8 weeks of Nicotine Replacement Therapy in the form of a patch."
1073154|NCT00632411|O2|Outcome|Reactive Group|"Participant will initiate contact with participant to conduct 6 individual counseling sessions.~Participants will receive 2 weeks of Nicotine Replacement Therapy in the form of a patch."
1073155|NCT00632411|O1|Outcome|Proactive Group|"Study staff will initiate contact to conduct 6 individual counseling sessions.~Participants will receive 8 weeks of Nicotine Replacement Therapy in the form of a patch."
1073156|NCT00632411|E2|Reported Event|Reactive Group|"Participant will initiate contact with participant to conduct 6 individual counseling sessions.~Participants will receive 2 weeks of Nicotine Replacement Therapy in the form of a patch."
1073157|NCT00632411|E1|Reported Event|Proactive Group|"Study staff will initiate contact to conduct 6 individual counseling sessions.~Participants will receive 8 weeks of Nicotine Replacement Therapy in the form of a patch."
1073158|NCT00632281|B1|Baseline|All Patients Receiving SBRT to Thorax|22 patients had Non-small-cell lung cancer (NSCLC), 6 had metastatic disease, and 6 had 2 lesions treated simultaneously.
1073159|NCT00632281|P1|Participant Flow|All Patients Receiving SBRT to Thorax|22 patients had Non-small-cell lung cancer (NSCLC), 6 had metastatic disease, and 6 had 2 lesions treated simultaneously.
1073160|NCT00632281|O1|Outcome|All Patients Receiving SBRT to the Thorax|
1073162|NCT00632281|E1|Reported Event|All Patients Receiving SBRT to Thorax|22 patients had Non-small-cell lung cancer (NSCLC), 6 had metastatic disease, and 6 had 2 lesions treated simultaneously.
1073163|NCT00632229|B3|Baseline|Total|Total of all reporting groups
1073164|NCT00632229|B2|Baseline|Placebo|"Placebo comparator~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
1073165|NCT00632229|B1|Baseline|Paliperidone|"Recieves study medication~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
1073166|NCT00632229|P2|Participant Flow|Placebo|"Placebo comparator~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
1073167|NCT00632229|P1|Participant Flow|Paliperidone|"Recieves study medication~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
1073168|NCT00632229|O2|Outcome|Placebo|"Placebo comparator~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
1073169|NCT00632229|O1|Outcome|Paliperidone|"Recieves study medication~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
1073170|NCT00632229|O2|Outcome|Placebo|"Placebo comparator~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
1073171|NCT00632229|O1|Outcome|Paliperidone|"Recieves study medication~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
1073172|NCT00632229|E2|Reported Event|Placebo|"Placebo comparator~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
1073173|NCT00632229|E1|Reported Event|Paliperidone|"Recieves study medication~Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy."
1073174|NCT00632203|B3|Baseline|Total|Total of all reporting groups
1073175|NCT00632203|B2|Baseline|Observation|Observation
1073176|NCT00632203|B1|Baseline|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
1073177|NCT00632203|P2|Participant Flow|Observation|Observation
1073178|NCT00632203|P1|Participant Flow|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
1073179|NCT00632203|O2|Outcome|Observation|Observation
1073180|NCT00632203|O1|Outcome|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
1073181|NCT00632203|O2|Outcome|Observation|Observation
1073182|NCT00632203|O1|Outcome|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
1073183|NCT00632203|O2|Outcome|Observation|Observation
1073184|NCT00632203|O1|Outcome|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
1073185|NCT00632203|O2|Outcome|Observation|Observation
1073186|NCT00632203|O1|Outcome|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
1073187|NCT00632203|O2|Outcome|Observation|Observation
1073188|NCT00632203|O1|Outcome|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
1073189|NCT00632203|O2|Outcome|Observation|Observation
1073190|NCT00632203|O1|Outcome|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
1073191|NCT00632203|O2|Outcome|Observation|Observation
1073192|NCT00632203|O1|Outcome|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
1073193|NCT00632203|E2|Reported Event|Observation|Observation
1073194|NCT00632203|E1|Reported Event|Temozolomide Treatment|Participants received temozolomide at a dose of 75 mg/m^2 orally (PO) daily for 21 consecutive days, followed by a 7-day rest period per 28-day cycle, until progression or up to a maximum of 6 cycles, whichever occurred first.
1073195|NCT00632099|B3|Baseline|Total|Total of all reporting groups
1073196|NCT00632099|B2|Baseline|Oral Micronized Progesterone|"Oral micronized progesterone (up to 400 mg/day)~Oral micronized progesterone: Oral micronized progesterone (up to 400 mg/day), suspended in olive oil"
1073197|NCT00632099|B1|Baseline|Matched Placebo|"matched placebo~Placebo: matched placebo"
1073198|NCT00632099|P2|Participant Flow|Oral Micronized Progesterone|"Oral micronized progesterone (up to 400 mg/day)~Oral micronized progesterone: Oral micronized progesterone (up to 400 mg/day), suspended in olive oil"
1073199|NCT00632099|P1|Participant Flow|Matched Placebo|"matched placebo~Placebo: matched placebo"
1073200|NCT00632099|O2|Outcome|Oral Micronized Progesterone|"Oral micronized progesterone (up to 400 mg/day)~Oral micronized progesterone: Oral micronized progesterone (up to 400 mg/day), suspended in olive oil"
1073201|NCT00632099|O1|Outcome|Matched Placebo|"matched placebo~Placebo: matched placebo"
1073202|NCT00632099|E2|Reported Event|Oral Micronized Progesterone|"Oral micronized progesterone (up to 400 mg/day)~Oral micronized progesterone: Oral micronized progesterone (up to 400 mg/day), suspended in olive oil"
1073203|NCT00632099|E1|Reported Event|Matched Placebo|"matched placebo~Placebo: matched placebo"
1073205|NCT00631969|B2|Baseline|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073206|NCT00631969|B1|Baseline|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073207|NCT00631969|P2|Participant Flow|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073208|NCT00631969|P1|Participant Flow|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073209|NCT00631969|O2|Outcome|ED Patients Aged ≥ 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged ≥ 65 years.
1073210|NCT00631969|O1|Outcome|ED Patients Aged < 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged < 65 years.
1073211|NCT00631969|O2|Outcome|ED Patients Aged ≥ 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged ≥ 65 years.
1073212|NCT00631969|O1|Outcome|ED Patients Aged < 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged < 65 years.
1073213|NCT00631969|O2|Outcome|ED Patients Aged ≥ 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged ≥ 65 years.
1073214|NCT00631969|O1|Outcome|ED Patients Aged < 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged < 65 years.
1073215|NCT00631969|O2|Outcome|ED Patients Aged ≥ 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged ≥ 65 years.
1073216|NCT00631969|O1|Outcome|ED Patients Aged < 65 Years|Vardenafil 10 mg orodispersible tablets (ODT) taken on demand (PRN) 1 hour before sexual activity for ED patients aged < 65 years.
1073217|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073218|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073219|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073220|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073221|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073222|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073223|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073224|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073225|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073226|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073227|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073228|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073229|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073230|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073231|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073232|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073233|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073234|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073235|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073236|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073237|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073238|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073239|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073280|NCT00631696|B2|Baseline|Placebo|Placebo matching pregabalin treatment.
1075883|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
1073240|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073241|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073242|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073243|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073244|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073245|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073246|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073247|NCT00631969|O2|Outcome|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073248|NCT00631969|O1|Outcome|Vardenafil ODT (STAXYN, BAY38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073249|NCT00631969|E2|Reported Event|Placebo|Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073250|NCT00631969|E1|Reported Event|Vardenafil ODT (STAXYN, BAY 38-9456)|Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
1073251|NCT00631917|B3|Baseline|Total|Total of all reporting groups
1073252|NCT00631917|B2|Baseline|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
1073253|NCT00631917|B1|Baseline|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
1073254|NCT00631917|P2|Participant Flow|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
1073255|NCT00631917|P1|Participant Flow|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
1073256|NCT00631917|O2|Outcome|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
1073257|NCT00631917|O1|Outcome|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
1073258|NCT00631917|O2|Outcome|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
1073259|NCT00631917|O1|Outcome|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
1073260|NCT00631917|O2|Outcome|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
1073261|NCT00631917|O1|Outcome|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
1073262|NCT00631917|O2|Outcome|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
1073263|NCT00631917|O1|Outcome|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
1073264|NCT00631917|O2|Outcome|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
1073265|NCT00631917|O1|Outcome|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
1073266|NCT00631917|E2|Reported Event|Ramipril|For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
1073267|NCT00631917|E1|Reported Event|Aliskiren|For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
1073268|NCT00631748|B3|Baseline|Total|Total of all reporting groups
1073269|NCT00631748|B2|Baseline|Placebo|Placebo (sugar pill)
1073270|NCT00631748|B1|Baseline|Study Drug|Oral quetiapine
1073281|NCT00631696|B1|Baseline|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
1073282|NCT00631696|P2|Participant Flow|Placebo|Placebo matching pregabalin treatment.
1073283|NCT00631696|P1|Participant Flow|Pregabalin|Pregabalin 50 milligrams (mg) by mouth (PO) twice a day (BID) starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
1073284|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
1073285|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
1073286|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
1073287|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
1073288|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
1073289|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
1073290|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
1073291|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
1073292|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
1073293|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
1073294|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
1073295|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
1073296|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
1073297|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
1073298|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
1073299|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
1073300|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
1073301|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
1073302|NCT00631696|O2|Outcome|Placebo|Placebo matching pregabalin treatment.
1073303|NCT00631696|O1|Outcome|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
1073304|NCT00631696|E2|Reported Event|Placebo|Placebo matching pregabalin treatment.
1073305|NCT00631696|E1|Reported Event|Pregabalin|Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
1073306|NCT00631670|B3|Baseline|Total|Total of all reporting groups
1073307|NCT00631670|B2|Baseline|25 Treatments Group|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment. Patients were offered the option to participate in which arm they preferred.
1073308|NCT00631670|B1|Baseline|Single Treatment Group|15 Gy dose of radiation in one treatment. Patients were offered the option of which arm they wished to participate in.
1073309|NCT00631670|P2|Participant Flow|25 Treatments Group|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment. Patients were offered the option to participate in which arm they preferred.
1073310|NCT00631670|P1|Participant Flow|Single Treatment Group|15 Gy dose of radiation in one treatment. Patients were offered the option of which arm they wished to participate in.
1073311|NCT00631670|O2|Outcome|25 Treatments Group|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment
1073312|NCT00631670|O1|Outcome|Single Treatment Group|15 Gy dose in one radiation treatment
1073313|NCT00631670|O2|Outcome|25 Treatments Group|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment
1073314|NCT00631670|O1|Outcome|Single Treatment Group|15 Gy dose in one radiation treatment
1073315|NCT00631670|O2|Outcome|25 Treatments Group|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment. Patients were offered the option to participate in which arm they preferred.
1073316|NCT00631670|O1|Outcome|Single Treatment Group|15 Gy dose of radiation in one treatment. Patients were offered the option of which arm they wished to participate in.
1073317|NCT00631670|O2|Outcome|25 Treatments Grouop|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment
1073318|NCT00631670|O1|Outcome|Single Treatment Group|15 Gy dose in one treatment
1073319|NCT00631670|O2|Outcome|25 Treatments Group|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment
1073320|NCT00631670|O1|Outcome|Single Treatment Group|15 Gy dose in one radiation treatment
1073321|NCT00631670|E2|Reported Event|25 Treatments Group|25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment. Patients were offered the option to participate in which arm they preferred.
1073322|NCT00631670|E1|Reported Event|Single Treatment Group|15 Gy dose of radiation in one treatment. Patients were offered the option of which arm they wished to participate in.
1073323|NCT00631657|B3|Baseline|Total|Total of all reporting groups
1075884|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
1073324|NCT00631657|B2|Baseline|Placebo|Participants receive placebo tablets, administered QD for 6 months
1073325|NCT00631657|B1|Baseline|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
1073326|NCT00631657|P3|Participant Flow|Placebo/Placebo|Participants receive placebo tablets, administered QD for 6 months, then participants receive placebo tablets, administered QD for 7 days
1073327|NCT00631657|P2|Participant Flow|Esmirtazapine 4.5 mg/Placebo|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months, then participants receive placebo tablets, administered QD for 7 days
1073328|NCT00631657|P1|Participant Flow|Esmirtazapine 4.5 mg/Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered once a day (QD) for 6 months, then participants receive esmirtazapine 4.5 mg tablets, administered QD for 7 days
1073329|NCT00631657|O3|Outcome|Placebo/Placebo|Participants receive placebo tablets, administered QD for 6 months during the Treatment Period, followed by placebo tablets, administered QD for 7 days during the Discontinuation Period
1073330|NCT00631657|O2|Outcome|Esmirtazapine 4.5 mg/Placebo|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months during the Treatment Period, followed by placebo tablets, administered QD for 7 days during the Discontinuation Period
1073331|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg/Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months during the Treatment Period, followed by esmirtazapine 4.5 mg tablets, administered QD for 7 days during the Discontinuation Period
1073332|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months.
1073333|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
1073334|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months
1073335|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
1073336|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months
1073337|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
1073338|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months
1073339|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
1073340|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months
1073341|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
1073342|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months
1073343|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
1073344|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months
1073345|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
1073346|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD
1073347|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
1073348|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD
1073349|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
1073350|NCT00631657|O2|Outcome|Placebo|Participants receive placebo tablets, administered QD for 6 months
1073351|NCT00631657|O1|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD for 6 months
1073352|NCT00631657|E2|Reported Event|Placebo|Participants receive placebo tablets, administered QD
1073353|NCT00631657|E1|Reported Event|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg tablets, administered QD
1073354|NCT00631540|B1|Baseline|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
1073355|NCT00631540|P1|Participant Flow|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
1073356|NCT00631540|O1|Outcome|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
1073357|NCT00631540|O1|Outcome|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
1073358|NCT00631540|O1|Outcome|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
1073359|NCT00631540|O1|Outcome|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
1073360|NCT00631540|O1|Outcome|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
1073361|NCT00631540|O1|Outcome|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
1073362|NCT00631540|E1|Reported Event|Formula™ Balloon-Expandable Renal Stent|renal artery stenting
1073363|NCT00631488|B4|Baseline|Total|Total of all reporting groups
1073364|NCT00631488|B3|Baseline|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
1073365|NCT00631488|B2|Baseline|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
1073366|NCT00631488|B1|Baseline|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
1073506|NCT00631020|B1|Baseline|CBME +/- NRT|6 weeks of once a week CBME with optional 4 weeks NRT
1073507|NCT00631020|P1|Participant Flow|CBME +/- NRT|6 weeks CBME with optional NRT for 4 weeks
1073367|NCT00631488|P3|Participant Flow|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
1073368|NCT00631488|P2|Participant Flow|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
1073369|NCT00631488|P1|Participant Flow|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
1073370|NCT00631488|O3|Outcome|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
1073371|NCT00631488|O2|Outcome|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
1073372|NCT00631488|O1|Outcome|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
1073373|NCT00631488|O3|Outcome|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
1073374|NCT00631488|O2|Outcome|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
1073375|NCT00631488|O1|Outcome|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
1073376|NCT00631488|O3|Outcome|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
1073377|NCT00631488|O2|Outcome|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
1073378|NCT00631488|O1|Outcome|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
1073379|NCT00631488|O3|Outcome|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
1073380|NCT00631488|O2|Outcome|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
1073381|NCT00631488|O1|Outcome|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
1073508|NCT00631020|O1|Outcome|CBME +/- NRT|6 weeks CBME with optional 4 weeks NRT
1073509|NCT00631020|O1|Outcome|CBME +/- NRT|6 weeks CBME with optional 4 weeks NRT
1073510|NCT00631020|O1|Outcome|CBME +/- NRT|6 weeks CBME with optional 4 weeks NRT
1073511|NCT00631020|O1|Outcome|CBME +/- NRT|6 weeks CBME with optional 4 weeks NRT
1073382|NCT00631488|O3|Outcome|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
1073383|NCT00631488|O2|Outcome|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
1073384|NCT00631488|O1|Outcome|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
1073385|NCT00631488|E3|Reported Event|Sitagliptin + Metformin|Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
1073386|NCT00631488|E2|Reported Event|MK-0893 + Metformin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 orally (40 mg tablets) administered daily throughout the double-blind treatment period. Participants received Metformin orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin was then administered throughout the double-blind treatment period.
1073387|NCT00631488|E1|Reported Event|MK-0893 + Sitagliptin|Participants received an initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period. Sitagliptin was administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period.
1073388|NCT00631475|B1|Baseline|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
1073389|NCT00631475|P1|Participant Flow|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
1073390|NCT00631475|O1|Outcome|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
1073391|NCT00631475|O1|Outcome|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
1073392|NCT00631475|O1|Outcome|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
1073393|NCT00631475|O1|Outcome|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
1073394|NCT00631475|O1|Outcome|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
1073395|NCT00631475|E1|Reported Event|Bosentan Treatment|Oral bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks, and oral bosentan 125 mg b.i.d. (62.5 mg b.i.d. if </= 40 kg) thereafter
1073396|NCT00631449|B3|Baseline|Total|Total of all reporting groups
1073397|NCT00631449|B2|Baseline|Placebo|For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
1073398|NCT00631449|B1|Baseline|Raltegravir|For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
1073399|NCT00631449|P2|Participant Flow|Placebo|For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
1073400|NCT00631449|P1|Participant Flow|Raltegravir|For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
1073401|NCT00631449|O2|Outcome|Placebo|For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
1073402|NCT00631449|O1|Outcome|Raltegravir|For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
1073403|NCT00631449|E2|Reported Event|Placebo|For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
1073404|NCT00631449|E1|Reported Event|Raltegravir|For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
1073405|NCT00631410|B3|Baseline|Total|Total of all reporting groups
1073406|NCT00631410|B2|Baseline|Treatment Arm B 50 mg/Day (2/2)|"Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2).~FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle."
1073512|NCT00631020|O1|Outcome|CBME +/- NRT|6 weeks CBME with optional 4 weeks NRT
1073513|NCT00631020|O1|Outcome|CBME +/- NRT|6 weeks CBME with optional 4 weeks NRT
1073407|NCT00631410|B1|Baseline|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
1073408|NCT00631410|P2|Participant Flow|Treatment Arm B 50 mg/Day (2/2)|Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2). A combination chemotherapy of fluorouracil, calcium folinate and oxaliplatin (FOLFOX) was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
1073409|NCT00631410|P1|Participant Flow|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). A combination chemotherapy of fluorouracil, calcium folinate and oxaliplatin (FOLFOX) was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
1073410|NCT00631410|O1|Outcome|Treatment Arm B 50 mg/Day (2/2)|Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
1073411|NCT00631410|O1|Outcome|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and ℓ-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
1073412|NCT00631410|O2|Outcome|Treatment Arm B 50 mg/Day (2/2)|Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
1073413|NCT00631410|O1|Outcome|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
1073414|NCT00631410|O2|Outcome|Treatment Arm B 50 mg/Day (2/2)|Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
1073415|NCT00631410|O1|Outcome|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
1073416|NCT00631410|O2|Outcome|Treatment Arm B 50 mg/Day (2/2)|Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
1073417|NCT00631410|O1|Outcome|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
1073418|NCT00631410|O1|Outcome|Treatment Arm B 50 mg/Day (2/2)|"Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2).~FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle."
1073419|NCT00631410|O1|Outcome|Treatment Arm B 50 mg/Day (2/2)|"Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2).~FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle."
1073514|NCT00631020|E1|Reported Event|CBME +/- NRT|6 weeks CBME with optional 4 weeks NRT
1073515|NCT00631007|B7|Baseline|Total|Total of all reporting groups
1073420|NCT00631410|O1|Outcome|Treatment Arm B 50 mg/Day (2/2)|"Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2).~FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle."
1073421|NCT00631410|O2|Outcome|Treatment Arm B 50 mg/Day (2/2)|Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
1073422|NCT00631410|O1|Outcome|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and ℓ-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
1073423|NCT00631410|E2|Reported Event|Treatment Arm B 50 mg/Day (2/2)|"Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2).~FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle."
1073424|NCT00631410|E1|Reported Event|Treatment Arm A 37.5 mg/Day (4/2)|Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
1073425|NCT00631371|B3|Baseline|Total|Total of all reporting groups
1073426|NCT00631371|B2|Baseline|Bevacizumab+ Interferon-Alfa|Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
1073427|NCT00631371|B1|Baseline|Bevacizumab+Temsirolimus|Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
1073428|NCT00631371|P2|Participant Flow|Bevacizumab+ Interferon-Alfa|Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
1073429|NCT00631371|P1|Participant Flow|Bevacizumab+Temsirolimus|Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
1073430|NCT00631371|O2|Outcome|Bevacizumab+ Interferon-Alfa|Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
1073431|NCT00631371|O1|Outcome|Bevacizumab+Temsirolimus|Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
1073432|NCT00631371|O2|Outcome|Bevacizumab+ Interferon-Alfa|Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
1073433|NCT00631371|O1|Outcome|Bevacizumab+Temsirolimus|Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
1073434|NCT00631371|O2|Outcome|Bevacizumab+ Interferon-Alfa|Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
1073435|NCT00631371|O1|Outcome|Bevacizumab+Temsirolimus|Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
1073436|NCT00631371|O2|Outcome|Bevacizumab+ Interferon-Alfa|Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
1073516|NCT00631007|B6|Baseline|Placebo|placebo administered once-daily
1073437|NCT00631371|O1|Outcome|Bevacizumab+Temsirolimus|Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
1073438|NCT00631371|E2|Reported Event|Bevacizumab+ Interferon-Alfa|Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
1073439|NCT00631371|E1|Reported Event|Bevacizumab+Temsirolimus|Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
1073440|NCT00631358|B3|Baseline|Total|Total of all reporting groups
1073441|NCT00631358|B2|Baseline|No Treatment|Healthy normal control group receiving no treatment
1073442|NCT00631358|B1|Baseline|Maxidex|Maxidex 1 drop in each eye 2 times daily
1073443|NCT00631358|P2|Participant Flow|No Treatment|Healthy normal control group receiving no treatment
1073444|NCT00631358|P1|Participant Flow|Maxidex|Maxidex 1 drop in each eye 2 times daily
1073445|NCT00631358|O2|Outcome|No Treatment|Healthy normal control group receiving no treatment
1073446|NCT00631358|O1|Outcome|Maxidex|Maxidex 1 drop in each eye 2 times daily
1073447|NCT00631358|O2|Outcome|No Treatment|Healthy normal control group receiving no treatment
1073448|NCT00631358|O1|Outcome|Maxidex|Maxidex 1 drop in each eye 2 times daily
1073449|NCT00631358|O2|Outcome|No Treatment|Healthy normal control group receiving no treatment
1073450|NCT00631358|O1|Outcome|Maxidex|Maxidex 1 drop in each eye 2 times daily
1073451|NCT00631358|O2|Outcome|No Treatment|Healthy normal control group receiving no treatment
1073452|NCT00631358|O1|Outcome|Maxidex|Maxidex 1 drop in each eye 2 times daily
1073453|NCT00631358|O2|Outcome|No Treatment|Healthy normal control group receiving no treatment
1073454|NCT00631358|O1|Outcome|Maxidex|Maxidex 1 drop in each eye 2 times daily
1073455|NCT00631358|E2|Reported Event|No Treatment|Healthy normal control group receiving no treatment
1073456|NCT00631358|E1|Reported Event|Maxidex|Maxidex 1 drop in each eye 2 times daily
1073457|NCT00631189|B5|Baseline|Total|Total of all reporting groups
1073458|NCT00631189|B4|Baseline|Rosuvastatin|Rosuvastatin 5 mg
1073459|NCT00631189|B3|Baseline|Pravastatin|Pravastatin 40 mg
1073460|NCT00631189|B2|Baseline|Atorvastatin|Atorvastatin 10 mg
1073461|NCT00631189|B1|Baseline|Initial Phase|Initial phase (between V1 and V2)
1073462|NCT00631189|P4|Participant Flow|Rosuvastatin|Rosuvastatin 5 mg
1073463|NCT00631189|P3|Participant Flow|Pravastatin|Pravastatin 40 mg
1073464|NCT00631189|P2|Participant Flow|Atorvastatin|Atorvastatin 10 mg
1073465|NCT00631189|P1|Participant Flow|Initial Phase|Initial phase (between V1 and V2)
1073466|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
1073467|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
1073468|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
1073469|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
1073470|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
1073471|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
1073472|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
1073473|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
1073474|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
1073475|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
1073476|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
1073477|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
1073478|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
1073479|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
1073480|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
1073481|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
1073482|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
1073483|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
1073484|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
1073485|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
1073486|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
1073487|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
1073488|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
1073489|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
1073490|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
1073491|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
1073492|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
1073493|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
1073494|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
1073495|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
1073496|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
1073497|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
1073498|NCT00631189|O4|Outcome|Rosuvastatin|Rosuvastatin 5 mg
1073499|NCT00631189|O3|Outcome|Pravastatin|Pravastatin 40 mg
1073500|NCT00631189|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
1073501|NCT00631189|O1|Outcome|Initial Phase|Initial phase (between V1 and V2)
1073502|NCT00631189|E4|Reported Event|Rosuvastatin|Rosuvastatin 5 mg
1073503|NCT00631189|E3|Reported Event|Pravastatin|Pravastatin 40 mg
1073504|NCT00631189|E2|Reported Event|Atorvastatin|Atorvastatin 10 mg
1073505|NCT00631189|E1|Reported Event|Initial Phase|Initial phase (between V1 and V2)
1073517|NCT00631007|B5|Baseline|Pioglitazone HCl 45 mg|pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
1073518|NCT00631007|B4|Baseline|INT131 Besylate 3 mg|INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
1073519|NCT00631007|B3|Baseline|INT131 Besylate 2 mg|INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
1073520|NCT00631007|B2|Baseline|INT131 Besylate 1 mg|INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
1073521|NCT00631007|B1|Baseline|INT131 Besylate 0.5 mg|INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
1073522|NCT00631007|P6|Participant Flow|Placebo|placebo administered once-daily
1073523|NCT00631007|P5|Participant Flow|Pioglitazone HCl 45 mg|pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
1073524|NCT00631007|P4|Participant Flow|INT131 Besylate 3 mg|INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
1073525|NCT00631007|P3|Participant Flow|INT131 Besylate 2 mg|INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
1073526|NCT00631007|P2|Participant Flow|INT131 Besylate 1 mg|INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
1073527|NCT00631007|P1|Participant Flow|INT131 Besylate 0.5 mg|INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
1073528|NCT00631007|O6|Outcome|Placebo|placebo administered once-daily
1073529|NCT00631007|O5|Outcome|Pioglitazone HCl 45 mg|pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
1073530|NCT00631007|O4|Outcome|INT131 Besylate 3 mg|INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
1073531|NCT00631007|O3|Outcome|INT131 Besylate 2 mg|INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
1073532|NCT00631007|O2|Outcome|INT131 Besylate 1 mg|INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
1073533|NCT00631007|O1|Outcome|INT131 Besylate 0.5 mg|INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
1073534|NCT00631007|O6|Outcome|Placebo|placebo administered once-daily
1073535|NCT00631007|O5|Outcome|Pioglitazone HCl 45 mg|pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
1073536|NCT00631007|O4|Outcome|INT131 Besylate 3 mg|INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
1073537|NCT00631007|O3|Outcome|INT131 Besylate 2 mg|INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
1073538|NCT00631007|O2|Outcome|INT131 Besylate 1 mg|INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
1073539|NCT00631007|O1|Outcome|INT131 Besylate 0.5 mg|INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
1073540|NCT00631007|E6|Reported Event|Placebo|placebo administered once-daily
1073541|NCT00631007|E5|Reported Event|Pioglitazone HCl 45 mg|pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
1073542|NCT00631007|E4|Reported Event|INT131 Besylate 3 mg|INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
1073543|NCT00631007|E3|Reported Event|INT131 Besylate 2 mg|INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
1073544|NCT00631007|E2|Reported Event|INT131 Besylate 1 mg|INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
1073545|NCT00631007|E1|Reported Event|INT131 Besylate 0.5 mg|INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
1073546|NCT00630994|B1|Baseline|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
1073547|NCT00630994|P1|Participant Flow|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
1073548|NCT00630994|O1|Outcome|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
1073549|NCT00630994|O1|Outcome|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
1073550|NCT00630994|O1|Outcome|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
1073551|NCT00630994|O1|Outcome|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
1073552|NCT00630994|O1|Outcome|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
1073553|NCT00630994|E1|Reported Event|Decitabine|20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle
1073554|NCT00630955|B4|Baseline|Total|Total of all reporting groups
1073555|NCT00630955|B3|Baseline|40 mg Memantine|
1073556|NCT00630955|B2|Baseline|20 mg Memantine|
1073557|NCT00630955|B1|Baseline|0 mg Memantine|
1073558|NCT00630955|P3|Participant Flow|40 mg Memantine|Participants randomized to 40mg memantine PO qd
1073559|NCT00630955|P2|Participant Flow|20 mg Memantine|Participants randomized to 20 mg memantine PO qd
1073560|NCT00630955|P1|Participant Flow|0 mg Memantine|Participants who received placebo PO qd
1073561|NCT00630955|O3|Outcome|40 mg Memantine|Participants randomized to 40mg memantine
1073562|NCT00630955|O2|Outcome|20 mg Memantine|Participants randomized to 20 mg memantine
1073563|NCT00630955|O1|Outcome|0 mg Memantine|Participants who received placebo
1073564|NCT00630955|O3|Outcome|40 mg Memantine|Participants randomized to 40mg memantine
1073565|NCT00630955|O2|Outcome|20 mg Memantine|Participants randomized to 20 mg memantine
1073566|NCT00630955|O1|Outcome|0 mg Memantine|Participants who received placebo
1073567|NCT00630955|E3|Reported Event|40 mg|Participants randomized to 40mg memantine
1073568|NCT00630955|E2|Reported Event|20 mg|Participants randomized to 20 mg memantine
1073569|NCT00630955|E1|Reported Event|0 mg|Participants who received placebo
1073570|NCT00630916|B1|Baseline|Mitroflow Aortic Pericardial Valve|Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
1073571|NCT00630916|P1|Participant Flow|Mitroflow Aortic Pericardial Valve|Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
1073572|NCT00630916|O1|Outcome|Mitroflow Aortic Pericardial Valve|Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
1073573|NCT00630916|O1|Outcome|Mitroflow Aortic Pericardial Valve|Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
1073574|NCT00630916|O1|Outcome|Mitroflow Aortic Pericardial Valve|Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
1073575|NCT00630916|O1|Outcome|Mitroflow Aortic Pericardial Valve|Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
1073576|NCT00630916|E1|Reported Event|Mitroflow Aortic Pericardial Valve|Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.
1073577|NCT00630877|B4|Baseline|Total|Total of all reporting groups
1073578|NCT00630877|B3|Baseline|NER Placebo/ASA Placebo|Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
1073579|NCT00630877|B2|Baseline|NER/ASA Placebo|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
1073580|NCT00630877|B1|Baseline|NER/ASA|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) 325 mg once daily
1073581|NCT00630877|P3|Participant Flow|NER Placebo/ASA Placebo|Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
1073582|NCT00630877|P2|Participant Flow|NER/ASA Placebo|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
1073583|NCT00630877|P1|Participant Flow|NER/ASA|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) 325 mg once daily
1073584|NCT00630877|O2|Outcome|Nonresponders|Subjects whose flushing symptoms did not change or worsened from study start to Day 43.
1073585|NCT00630877|O1|Outcome|Responders|Subjects whose flushing symptoms improved from study start to Day 43.
1073586|NCT00630877|O2|Outcome|Nonresponders|Subjects whose flushing symptoms did not change or worsened from study start to Day 43.
1073587|NCT00630877|O1|Outcome|Responders|Subjects whose flushing symptoms improved from study start to Day 43.
1073588|NCT00630877|O1|Outcome|Modified Intent-to-Treat (m-ITT) Population|All subjects who received study drug and had an entry in the e-diary.
1073589|NCT00630877|O1|Outcome|Modified Intent-to-Treat (m-ITT) Population|All subjects who received study drug and had an entry in the e-diary.
1073590|NCT00630877|O1|Outcome|Modified Intent-to-Treat (m-ITT) Population|All subjects who received study drug and had an entry in the e-diary.
1073591|NCT00630877|O1|Outcome|Modified Intent-to-Treat (m-ITT) Population|All subjects who received study drug and had an entry in the e-diary.
1073592|NCT00630877|O1|Outcome|Subjects With Stable Flushing Symptoms|Subjects whose flushing symptoms remained stable from Week 1 to Week 2
1073593|NCT00630877|O3|Outcome|NER Placebo/ASA Placebo|Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
1073594|NCT00630877|O2|Outcome|NER/ASA Placebo|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
1073595|NCT00630877|O1|Outcome|NER/ASA|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) 325 mg once daily
1073596|NCT00630877|O1|Outcome|Subjects With Stable Flushing Symptoms|Subjects whose flushing symptoms remained stable from Week 1 to Week 2
1073597|NCT00630877|E3|Reported Event|NER Placebo/ASA Placebo|Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
1073598|NCT00630877|E2|Reported Event|NER/ASA Placebo|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily
1073599|NCT00630877|E1|Reported Event|NER/ASA|Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) 325 mg once daily
1073600|NCT00630864|B1|Baseline|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073601|NCT00630864|P1|Participant Flow|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073602|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073603|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073604|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073605|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073662|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
1073842|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
1073606|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073607|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073608|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073609|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073610|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073611|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073612|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073613|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073614|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073615|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073616|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073617|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073618|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073619|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073620|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073621|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073622|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073887|NCT00630487|O1|Outcome|Placebo|
1073623|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073624|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073625|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073626|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073627|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073628|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073629|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073630|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073631|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073632|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073633|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073634|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073635|NCT00630864|O1|Outcome|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073636|NCT00630864|E1|Reported Event|Tafamidis|Participants with transthyretin (TTR) variants other than valine replaced by methionine at position 30 (V30M) received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily up to Week 6 in Part 1, participants who achieved TTR stabilization at Week 6 or as per investigator’s discretion continued to receive tafamidis (Fx-1006A) 20 mg capsule orally once daily up to Month 12 in Part 2.
1073637|NCT00630838|B3|Baseline|Total|Total of all reporting groups
1073638|NCT00630838|B2|Baseline|Placebo|"Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months~Placebo : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months"
1073639|NCT00630838|B1|Baseline|VSL#3 Probiotic|"VSL#3 probiotic~VSL#3 : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (360 billion bacteria or 4 sachets) of VSL#3 will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (180 billion bacteria or 2 sachets) daily in the same amount of formula or breast milk.~E.2.6. Time of start of probiotics: Probiotic vs. placebo will begin once the infant has reached full oral feeding."
1073640|NCT00630838|P2|Participant Flow|Placebo|"Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months~Placebo : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months"
1073641|NCT00630838|P1|Participant Flow|VSL#3 Probiotic|"VSL#3 probiotic~VSL#3 : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (360 billion bacteria or 4 sachets) of VSL#3 will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (180 billion bacteria or 2 sachets) daily in the same amount of formula or breast milk.~E.2.6. Time of start of probiotics: Probiotic vs. placebo will begin once the infant has reached full oral feeding."
1073642|NCT00630838|O2|Outcome|Placebo|"Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months~Placebo : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months"
1073643|NCT00630838|O1|Outcome|VSL#3 Probiotic|"VSL#3 : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (360 billion bacteria or 4 sachets) of VSL#3 will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (180 billion bacteria or 2 sachets) daily in the same amount of formula or breast milk.~E.2.6. Time of start of probiotics: Probiotic vs. placebo will begin once the infant has reached full oral feeding."
1073644|NCT00630838|O2|Outcome|Placebo|"Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months~Placebo: Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months"
1073645|NCT00630838|O1|Outcome|VSL#3 Probiotic|"VSL#3: Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (360 billion bacteria or 4 sachets) of VSL#3 will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (180 billion bacteria or 2 sachets) daily in the same amount of formula or breast milk.~E.2.6. Time of start of probiotics: Probiotic vs. placebo will begin once the infant has reached full oral feeding."
1073646|NCT00630838|E2|Reported Event|Placebo|"Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months~Placebo : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast milk Initiation: within one week of pullthrough Duration: 3 months"
1073647|NCT00630838|E1|Reported Event|VSL#3 Probiotic|"VSL#3 : Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (360 billion bacteria or 4 sachets) of VSL#3 will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (180 billion bacteria or 2 sachets) daily in the same amount of formula or breast milk.~E.2.6. Time of start of probiotics: Probiotic vs. placebo will begin once the infant has reached full oral feeding."
1073648|NCT00630825|B5|Baseline|Total|Total of all reporting groups
1073649|NCT00630825|B4|Baseline|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
1073650|NCT00630825|B3|Baseline|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
1073651|NCT00630825|B2|Baseline|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
1073652|NCT00630825|B1|Baseline|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
1073653|NCT00630825|P4|Participant Flow|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
1073654|NCT00630825|P3|Participant Flow|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
1073655|NCT00630825|P2|Participant Flow|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
1073656|NCT00630825|P1|Participant Flow|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
1073657|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
1073658|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
1073659|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
1073660|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
1073661|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
1073663|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
1073664|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
1073665|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
1073666|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
1073667|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
1073668|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
1073669|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
1073670|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
1073671|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
1073672|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
1073673|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
1073674|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
1073675|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
1073676|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
1073677|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
1073678|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
1073679|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
1073680|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
1073681|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
1073682|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
1073683|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
1073684|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
1073685|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
1073686|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
1073687|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
1073688|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
1073689|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
1073690|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
1073691|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
1073692|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
1073693|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
1073694|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
1073695|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
1073696|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
1073697|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
1073698|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
1073699|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
1073700|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
1073701|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
1073702|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
1073703|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
1073704|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
1073705|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
1073706|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
1073707|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
1073708|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
1073709|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
1073710|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
1073711|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
1073712|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
1073713|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
1073714|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
1073715|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
1073716|NCT00630825|O4|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
1073717|NCT00630825|O3|Outcome|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
1073718|NCT00630825|O2|Outcome|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
1073719|NCT00630825|O1|Outcome|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
1073720|NCT00630825|E4|Reported Event|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 16 weeks
1073721|NCT00630825|E3|Reported Event|0.5/1.0 Milligram (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
1073722|NCT00630825|E2|Reported Event|1.0/1.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 16 weeks
1073723|NCT00630825|E1|Reported Event|1.0/2.0 Milligram (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
1073724|NCT00630786|B4|Baseline|Total|Total of all reporting groups
1073725|NCT00630786|B3|Baseline|Unknown KRAS|Participants with unknown Kirsten Rat Sarcoma Virus Oncogene (KRAS) type received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
1073726|NCT00630786|B2|Baseline|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
1073727|NCT00630786|B1|Baseline|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
1073728|NCT00630786|P3|Participant Flow|Unknown KRAS|Participants with unknown Kirsten Rat Sarcoma Virus Oncogene (KRAS) type received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
1073729|NCT00630786|P2|Participant Flow|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
1073730|NCT00630786|P1|Participant Flow|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
1073731|NCT00630786|O1|Outcome|Panitumumab Plus Conatumumab|Participants received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
1073732|NCT00630786|O1|Outcome|Panitumumab Plus Conatumumab|Participants received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
1073733|NCT00630786|O1|Outcome|Panitumumab Plus Conatumumab|Participants received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
1073734|NCT00630786|O2|Outcome|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
1073735|NCT00630786|O1|Outcome|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
1073736|NCT00630786|O2|Outcome|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
1073968|NCT00630331|E1|Reported Event|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
1073737|NCT00630786|O1|Outcome|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
1073738|NCT00630786|O2|Outcome|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
1073739|NCT00630786|O1|Outcome|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
1073740|NCT00630786|O2|Outcome|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
1073741|NCT00630786|O1|Outcome|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
1073742|NCT00630786|O2|Outcome|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
1073743|NCT00630786|O1|Outcome|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
1073744|NCT00630786|O2|Outcome|Mutant KRAS|Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
1073745|NCT00630786|O1|Outcome|Wild-type KRAS|Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
1073746|NCT00630786|O1|Outcome|Panitumumab Plus Conatumumab|Participants received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
1073747|NCT00630786|E1|Reported Event|Panitumumab + AMG 655|
1073748|NCT00630747|B1|Baseline|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
1073749|NCT00630747|P1|Participant Flow|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 milligram per kilogram (mg/kg) administered by intravenous (IV) infusion once-weekly.
1073750|NCT00630747|O1|Outcome|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
1073751|NCT00630747|O1|Outcome|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
1073752|NCT00630747|O1|Outcome|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
1073753|NCT00630747|O1|Outcome|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
1073754|NCT00630747|O1|Outcome|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
1073755|NCT00630747|O1|Outcome|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
1073756|NCT00630747|E1|Reported Event|Idursulfase (0.5 mg/kg, IV, Once-weekly)|Idursulfase 0.5 mg/kg administered by IV infusion once-weekly.
1073757|NCT00630734|B4|Baseline|Total|Total of all reporting groups
1073758|NCT00630734|B3|Baseline|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
1073759|NCT00630734|B2|Baseline|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
1073760|NCT00630734|B1|Baseline|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
1073761|NCT00630734|P3|Participant Flow|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
1073762|NCT00630734|P2|Participant Flow|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18.
1073763|NCT00630734|P1|Participant Flow|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
1073764|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
1073765|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18.
1073766|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
1073840|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
1073767|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
1073768|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18.
1073769|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
1073770|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
1073771|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18.
1073772|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
1073773|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
1073774|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18.
1073775|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
1073776|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
1073777|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
1073778|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
1073779|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
1073780|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
1073781|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
1073782|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
1073783|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
1073784|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
1073785|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
1073786|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
1073787|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
1073788|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
1073789|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
1073790|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
1073791|NCT00630734|O3|Outcome|SLCO1B1 Group 3|Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
1073792|NCT00630734|O2|Outcome|SLCO1B1 Group 2|SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
1073841|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
1073793|NCT00630734|O1|Outcome|SLCO1B1 Group 1|SLCO1B1*1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
1073794|NCT00630734|E3|Reported Event|Pravastatin + Darunavir/Ritonavir|Darunavir/ritonavir 600/100 mg by mouth twice daily and pravastatin 40 mg by mouth once daily on days 15-18. Includes 28 participants who received at least one dose of darunavir/ritonavir and pravastatin during days 15-18.
1073795|NCT00630734|E2|Reported Event|Darunavir/Ritonavir Alone|Darunavir/Ritonavir 600/100 mg by mouth twice daily on days 12-14; Includes 31 participants who received at least one dose of darunavir/ritonavir during days 12-14.
1073796|NCT00630734|E1|Reported Event|Pravastatin Alone|Pravastatin 40 mg by mouth daily on days 1-4; Includes 32 participants who received at least one dose of pravastatin 40 mg during days 1-4.
1073797|NCT00629850|B3|Baseline|Total|Total of all reporting groups
1073798|NCT00629850|B2|Baseline|Control|This arm of the study will not receive the device.
1073799|NCT00629850|B1|Baseline|Powerlung Trainer Device|The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.
1073800|NCT00629850|P2|Participant Flow|Control|This arm of the study will not receive the device.
1073801|NCT00629850|P1|Participant Flow|Powerlung Trainer Device|The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.
1073802|NCT00629850|O2|Outcome|Control|This arm of the study will not receive the device.
1073803|NCT00629850|O1|Outcome|Powerlung Trainer Device|The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.
1073804|NCT00629850|O2|Outcome|Control|This arm of the study will not receive the device.
1073805|NCT00629850|O1|Outcome|Powerlung Trainer Device|The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.
1073806|NCT00629850|O2|Outcome|Control|This arm of the study will not receive the device.
1073807|NCT00629850|O1|Outcome|Powerlung Trainer Device|The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.
1073808|NCT00629850|E2|Reported Event|Control|This arm of the study will not receive the device.
1073809|NCT00629850|E1|Reported Event|Powerlung Trainer Device|The device was used twice a day. Each use consisted of two sets of 10 breaths for each set.
1073810|NCT00630539|B5|Baseline|Total|Total of all reporting groups
1073811|NCT00630539|B4|Baseline|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
1073812|NCT00630539|B3|Baseline|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
1073813|NCT00630539|B2|Baseline|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
1073814|NCT00630539|B1|Baseline|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
1073815|NCT00630539|P4|Participant Flow|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
1073816|NCT00630539|P3|Participant Flow|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
1073817|NCT00630539|P2|Participant Flow|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
1073818|NCT00630539|P1|Participant Flow|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
1073819|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
1073820|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
1073821|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
1073822|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
1073823|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
1073824|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
1073825|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
1073826|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
1073827|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
1073828|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
1073829|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
1073830|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
1073831|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
1073832|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
1073833|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
1073834|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
1073835|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
1073836|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
1073837|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
1073838|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
1073839|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
1073843|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
1073844|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
1073845|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
1073846|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
1073847|NCT00630539|O8|Outcome|Subjects on Ospemifene 30 mg/Day (Week 12)|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
1073848|NCT00630539|O7|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
1073849|NCT00630539|O6|Outcome|Subjects on Ospemifine 15 mg/Day (Week 12)|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
1073850|NCT00630539|O5|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
1073851|NCT00630539|O4|Outcome|Subjects on Ospemifene 5 mg/Day (Week 12)|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
1073852|NCT00630539|O3|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
1073853|NCT00630539|O2|Outcome|Subjects on Placebo (Week 12)|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
1073854|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
1073855|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
1073856|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
1073857|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
1073858|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
1073859|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
1073860|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
1073861|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
1073862|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
1073863|NCT00630539|O4|Outcome|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
1073864|NCT00630539|O3|Outcome|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
1073865|NCT00630539|O2|Outcome|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
1073866|NCT00630539|O1|Outcome|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
1073867|NCT00630539|E4|Reported Event|Subjects on Ospemifene 30 mg/Day|Subjects took 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks
1073868|NCT00630539|E3|Reported Event|Subjects on Ospemifene 15 mg/Day|Subjects took 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
1073869|NCT00630539|E2|Reported Event|Subjects on Ospemifene 5 mg/Day|Subjects took 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
1073870|NCT00630539|E1|Reported Event|Subjects on Placebo|Subjects took 1 placebo tablet daily (in the morning with food) for 12 weeks
1073871|NCT00630487|B3|Baseline|Total|Total of all reporting groups
1073872|NCT00630487|B2|Baseline|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
1073873|NCT00630487|B1|Baseline|Placebo|
1073874|NCT00630487|P2|Participant Flow|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
1073875|NCT00630487|P1|Participant Flow|Placebo|
1073876|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
1073877|NCT00630487|O1|Outcome|Placebo|
1073878|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
1073879|NCT00630487|O1|Outcome|Placebo|
1073880|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
1073881|NCT00630487|O1|Outcome|Placebo|
1073882|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
1073883|NCT00630487|O1|Outcome|Placebo|
1073884|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
1073885|NCT00630487|O1|Outcome|Placebo|
1073886|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
1073888|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
1073889|NCT00630487|O1|Outcome|Placebo|
1073890|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
1073891|NCT00630487|O1|Outcome|Placebo|
1073892|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
1073893|NCT00630487|O1|Outcome|Placebo|
1073894|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
1073895|NCT00630487|O1|Outcome|Placebo|
1073896|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
1073897|NCT00630487|O1|Outcome|Placebo|
1073898|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
1073899|NCT00630487|O1|Outcome|Placebo|
1073900|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
1073901|NCT00630487|O1|Outcome|Placebo|
1073902|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
1073903|NCT00630487|O1|Outcome|Placebo|
1073904|NCT00630487|O2|Outcome|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
1073905|NCT00630487|O1|Outcome|Placebo|
1073906|NCT00630487|E2|Reported Event|Somatropin|Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
1073907|NCT00630487|E1|Reported Event|Placebo|
1073908|NCT00630409|B1|Baseline|Gemcitabine 800 mg/m^2 + Doxil 24 mg/m^2 (IV)|"Patients will receive 3 cycles of therapy as an outpatient. Each 21-day cycle of therapy will comprise: Gemcitabine: IV on days 1 and 8. Doxil: on day 1. Patients with either responding or stable disease will continue to receive additional 3 cycles of therapy with gemcitabine and Doxil until there is radiological evidence of disease progression or they are unable or unwilling to continue treatment.~Gemcitabine: 800 mg IV day 1 and 8~Doxil: 24 mg/m2 every 21 days IV"
1073909|NCT00630409|P1|Participant Flow|Gemcitabine 800 mg/m^2 + Doxil 24 mg/m^2 (IV)|"Patients will receive 3 cycles of therapy as an outpatient. Each 21-day cycle of therapy will comprise: Gemcitabine: IV on days 1 and 8. Doxil: on day 1. Patients with either responding or stable disease will continue to receive additional 3 cycles of therapy with gemcitabine and Doxil until there is radiological evidence of disease progression or they are unable or unwilling to continue treatment.~Gemcitabine: 800 mg IV day 1 and 8~Doxil: 24 mg/m2 every 21 days IV"
1073910|NCT00630409|O1|Outcome|Gemcitabine 800 mg/m^2 + Doxil 24 mg/m^2 (IV)|"Patients will receive 3 cycles of therapy as an outpatient. Each 21-day cycle of therapy will comprise: Gemcitabine: IV on days 1 and 8. Doxil: on day 1. Patients with either responding or stable disease will continue to receive additional 3 cycles of therapy with gemcitabine and Doxil until there is radiological evidence of disease progression or they are unable or unwilling to continue treatment.~Gemcitabine: 800 mg IV day 1 and 8 + Doxil: 24 mg/m2 every 21 days IV"
1073911|NCT00630409|O1|Outcome|Gemcitabine 800 mg/m^2 + Doxil 24 mg/m^2 (IV)|"Patients will receive 3 cycles of therapy as an outpatient. Each 21-day cycle of therapy will comprise: Gemcitabine: IV on days 1 and 8. Doxil: on day 1. Patients with either responding or stable disease will continue to receive additional 3 cycles of therapy with gemcitabine and Doxil until there is radiological evidence of disease progression or they are unable or unwilling to continue treatment.~Gemcitabine: 800 mg IV day 1 and 8~Doxil: 24 mg/m2 every 21 days IV"
1073912|NCT00630409|E1|Reported Event|Gemcitabine 800 mg/m^2 + Doxil 24 mg/m^2 (IV)|"Patients will receive 3 cycles of therapy as an outpatient. Each 21-day cycle of therapy will comprise: Gemcitabine: IV on days 1 and 8. Doxil: on day 1. Patients with either responding or stable disease will continue to receive additional 3 cycles of therapy with gemcitabine and Doxil until there is radiological evidence of disease progression or they are unable or unwilling to continue treatment.~Gemcitabine: 800 mg IV day 1 and 8~Doxil: 24 mg/m2 every 21 days IV"
1073913|NCT00630396|B1|Baseline|Minocycline|All 60 participants were treated with minocycline. 11 participants were treated at 3mg/kg, 4 were treated at 4.5mg/kg, 4 were treated at 6mg/kg, and 41 were treated at 10mg/kg.
1073914|NCT00630396|P1|Participant Flow|Minocycline|All 60 participants were treated with minocycline. 11 participants were treated at 3mg/kg, 4 were treated at 4.5mg/kg, 4 were treated at 6mg/kg, and 41 were treated at 10mg/kg.
1073915|NCT00630396|O1|Outcome|Minocycline|All 60 participants were treated with minocycline. 11 participants were treated at 3mg/kg, 4 were treated at 4.5mg/kg, 4 were treated at 6mg/kg, and 41 were treated at 10mg/kg.
1073916|NCT00630396|O1|Outcome|Minocycline|All 60 participants were treated with minocycline. 11 participants were treated at 3mg/kg, 4 were treated at 4.5mg/kg, 4 were treated at 6mg/kg, and 41 were treated at 10mg/kg.
1073969|NCT00630305|B1|Baseline|All Subjects|All subjects who were enrolled, randomized, and assigned to a study arm.
1073917|NCT00630396|O1|Outcome|Minocycline|All 60 participants were treated with minocycline. 11 participants were treated at 3mg/kg, 4 were treated at 4.5mg/kg, 4 were treated at 6mg/kg, and 41 were treated at 10mg/kg.
1073918|NCT00630396|E1|Reported Event|Minocycline|All 60 participants were treated with minocycline. 11 participants were treated at 3mg/kg, 4 were treated at 4.5mg/kg, 4 were treated at 6mg/kg, and 41 were treated at 10mg/kg.
1073919|NCT00630344|B1|Baseline|RAD-001 in Combination With Bicalutamide|"RAD001 will be administered orally as once daily dose of 10 mg (5 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. Bicalutamide will be administered orally as once daily dose of 50 mg (50 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity.~RAD001: Taken orally once daily~Bicalutamide: Taken orally once daily"
1073920|NCT00630344|P1|Participant Flow|RAD-001 in Combination With Bicalutamide|"RAD001 will be administered orally as once daily dose of 10 mg (5 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. Bicalutamide will be administered orally as once daily dose of 50 mg (50 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity.~RAD001: Taken orally once daily~Bicalutamide: Taken orally once daily"
1073921|NCT00630344|O1|Outcome|RAD-001 in Combination With Bicalutamide|"RAD001 will be administered orally as once daily dose of 10 mg (5 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. Bicalutamide will be administered orally as once daily dose of 50 mg (50 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity.~RAD001: Taken orally once daily~Bicalutamide: Taken orally once daily"
1073922|NCT00630344|E1|Reported Event|RAD-001 in Combination With Bicalutamide|"RAD001 will be administered orally as once daily dose of 10 mg (5 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity. Bicalutamide will be administered orally as once daily dose of 50 mg (50 mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity.~RAD001: Taken orally once daily~Bicalutamide: Taken orally once daily"
1073923|NCT00630331|B4|Baseline|Total|Total of all reporting groups
1073924|NCT00630331|B3|Baseline|Placebo|One dose of phosphate buffered solution (PBS).
1073925|NCT00630331|B2|Baseline|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
1073926|NCT00630331|B1|Baseline|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
1073927|NCT00630331|P3|Participant Flow|Placebo|One dose of phosphate buffered solution (PBS).
1073928|NCT00630331|P2|Participant Flow|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
1073929|NCT00630331|P1|Participant Flow|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
1073930|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
1073931|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
1073932|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
1073933|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
1073934|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
1073935|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
1073936|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
1073937|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
1073938|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
1073939|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
1073940|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
1073941|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
1073942|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
1073943|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
1073944|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
1073945|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
1073946|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
1073947|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
1073948|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
1073949|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
1073950|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
1073951|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
1073952|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
1073953|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
1073954|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
1073955|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
1073956|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
1073957|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
1073958|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
1073959|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
1073960|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
1073961|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
1073962|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
1073963|NCT00630331|O3|Outcome|Placebo|One dose of phosphate buffered solution (PBS).
1073964|NCT00630331|O2|Outcome|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
1073965|NCT00630331|O1|Outcome|CCI Vaccine|One dose of cell culture-derived influenza vaccine.
1073966|NCT00630331|E3|Reported Event|Placebo|One dose of phosphate buffered solution (PBS).
1073967|NCT00630331|E2|Reported Event|IVV Vaccine|One dose of the trivalent egg-derived influenza virus vaccine.
1073970|NCT00630305|P1|Participant Flow|Overall|subjects were randomized to a session (A, B, C and D) and then to one of four lens sequences. Each subject participated in every session.
1073971|NCT00630305|O4|Outcome|Sequence 4|Subjects that first received lotrafilcon B in their right eye and then received lotrafilcon B in their left eye.
1073972|NCT00630305|O3|Outcome|Sequence 3|Subjects that first received senofilcon A in their right eye and then received senofilcon A in their left eye.
1073973|NCT00630305|O2|Outcome|Sequence 2|Subjects that first recieved lotrafilcon B in their right eye and then received senofilcon A in their left eye.
1073974|NCT00630305|O1|Outcome|Sequence 1|Subjects that first received senofilcon A in their right eye and then received lotrafilcon B in their left eye.
1073975|NCT00630305|O4|Outcome|Sequence 4|Subjects that first received lotrafilcon B in their right eye and then received lotrafilcon B in their left eye.
1073976|NCT00630305|O3|Outcome|Sequence 3|Subjects that first received senofilcon A in their right eye and then received senofilcon A in their left eye.
1073977|NCT00630305|O2|Outcome|Sequence 2|Subjects that first recieved lotrafilcon B in their right eye and then received senofilcon A in their left eye.
1073978|NCT00630305|O1|Outcome|Sequence 1|Subjects that first received senofilcon A in their right eye and then received lotrafilcon B in their left eye.
1073979|NCT00630305|O4|Outcome|Sequence 4|Subjects that first received alphafilcon A in their right eye and then received alphafilcon A in their left eye.
1073980|NCT00630305|O3|Outcome|Sequence 3|Subjects that first received senofilcon A in their right eye and then received senofilcon A in their left eye.
1073981|NCT00630305|O2|Outcome|Sequence 2|Subjects that first recieved alphafilcon A in their right eye and then received senofilcon A in their left eye.
1073982|NCT00630305|O1|Outcome|Sequence 1|Subjects that first received senofilcon A in their right eye and then received alphafilcon A in their left eye.
1073983|NCT00630305|O4|Outcome|Sequence 4|Subjects that first received alphafilcon A in their right eye and then received alphafilcon A in their left eye.
1073984|NCT00630305|O3|Outcome|Sequence 3|Subjects that first received senofilcon A in their right eye and then received senofilcon A in their left eye.
1073985|NCT00630305|O2|Outcome|Sequence 2|Subjects that first recieved alphafilcon A in their right eye and then received senofilcon A in their left eye.
1073986|NCT00630305|O1|Outcome|Sequence 1|Subjects that first received senofilcon A in their right eye and then received alphafilcon A in their left eye.
1073987|NCT00630305|E4|Reported Event|Session D|"Closed eye session, this session includes the following sequences only:~senofilcon A/ lotrafilcon B~lotrafilcon B / senofilcon A~senofilcon A/ senofilcon A~lotrafilcon B / lotrafilcon B"
1073988|NCT00630305|E3|Reported Event|Session C|"Open eye session, this session includes the following sequences only:~senofilcon A/ lotrafilcon B~lotrafilcon B / senofilcon A~senofilcon A/ senofilcon A~lotrafilcon B / lotrafilcon B"
1073989|NCT00630305|E2|Reported Event|Session B|"Closed eye session, this session includes the following sequences only:~senofilcon A/ alphafilcon A~alphafilcon A/ senofilcon A~senofilcon A/ senofilcon A~alphafilcon A/ alphafilcon A"
1073990|NCT00630305|E1|Reported Event|Session A|"Open eye session, this session includes the following sequences only:~senofilcon A / alphafilcon A~alphafilcon A / senofilcon A~senofilcon A / senofilcon A~alphafilcon A / alphafilcon A"
1073991|NCT00630292|B1|Baseline|Breast Magnetic Resonance Angiography|Women who had a Magnetic Resonance Angiography sequence added to a clinical breast MRI
1073992|NCT00630292|P1|Participant Flow|Breast Magnetic Resonance Angiography|Women who had a Magnetic Resonance Angiography sequence added to a clinical breast MRI
1073993|NCT00630292|O1|Outcome|Breast Magnetic Resonance Angiography|Women who had a Magnetic Resonance Angiography sequence added to a clinical breast MRI
1073994|NCT00630292|E1|Reported Event|Breast Magnetic Resonance Angiography|Women who had a Magnetic Resonance Angiography sequence added to a clinical breast MRI
1073995|NCT00630058|B3|Baseline|Total|Total of all reporting groups
1073996|NCT00630058|B2|Baseline|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
1073997|NCT00630058|B1|Baseline|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
1073998|NCT00630058|P2|Participant Flow|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
1073999|NCT00630058|P1|Participant Flow|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
1074000|NCT00630058|O2|Outcome|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
1074001|NCT00630058|O1|Outcome|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
1074002|NCT00630058|O2|Outcome|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
1074003|NCT00630058|O1|Outcome|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
1074004|NCT00630058|O2|Outcome|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
1074005|NCT00630058|O1|Outcome|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
1074006|NCT00630058|O2|Outcome|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
1074007|NCT00630058|O1|Outcome|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
1074008|NCT00630058|O2|Outcome|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
1074009|NCT00630058|O1|Outcome|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
1074010|NCT00630058|O2|Outcome|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
1074011|NCT00630058|O1|Outcome|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
1074012|NCT00630058|E2|Reported Event|Group B (MP-424 Low)|"Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
1074013|NCT00630058|E1|Reported Event|Group A (MP-424 High)|"Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir~Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks~Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks"
1074014|NCT00629772|B3|Baseline|Total|Total of all reporting groups
1074015|NCT00629772|B2|Baseline|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
1074016|NCT00629772|B1|Baseline|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
1074017|NCT00629772|P2|Participant Flow|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
1074018|NCT00629772|P1|Participant Flow|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
1074019|NCT00629772|O1|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
1074020|NCT00629772|O1|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
1074021|NCT00629772|O1|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
1074022|NCT00629772|O1|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
1074023|NCT00629772|O2|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
1074024|NCT00629772|O1|Outcome|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
1074025|NCT00629772|O2|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
1074026|NCT00629772|O1|Outcome|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
1074027|NCT00629772|O2|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
1074028|NCT00629772|O1|Outcome|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
1074029|NCT00629772|O2|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
1074030|NCT00629772|O1|Outcome|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
1074031|NCT00629772|O2|Outcome|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
1074032|NCT00629772|O1|Outcome|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
1074033|NCT00629772|E2|Reported Event|Placebo Then Infliximab|Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
1074034|NCT00629772|E1|Reported Event|Infliximab|Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22 throughout the entire study.
1074035|NCT00629707|B3|Baseline|Total|Total of all reporting groups
1074036|NCT00629707|B2|Baseline|Rapid Fluid Infusion|More rapid infusion: Patients in this arm will receive an initial bolus of 20 cc/Kg of intravenous fluids followed by replacement of an estimated deficit of 10% of body weight over 36 hours plus replacement of 1/2 of urine output volume.
1074037|NCT00629707|B1|Baseline|Slow Fluid Infusion|Slower infusion rate: Patients in this arm will receive an initial intravenous fluid bolus of 10cc/Kg followed by rehydration calculated to replace a deficit of 7.5% of body weight over 48 hours.
1074038|NCT00629707|P2|Participant Flow|Rapid Fluid Infusion|More rapid infusion: Patients in this arm will receive an initial bolus of 20 cc/Kg of intravenous fluids followed by replacement of an estimated deficit of 10% of body weight over 36 hours plus replacement of 1/2 of urine output volume.
1074039|NCT00629707|P1|Participant Flow|Slow Fluid Infusion|Slower infusion rate: Patients in this arm will receive an initial intravenous fluid bolus of 10cc/Kg followed by rehydration calculated to replace a deficit of 7.5% of body weight over 48 hours.
1074040|NCT00629707|O2|Outcome|Rapid Fluid Infusion|More rapid infusion: Patients in this arm will receive an initial bolus of 20 cc/Kg of intravenous fluids followed by replacement of an estimated deficit of 10% of body weight over 36 hours plus replacement of 1/2 of urine output volume.
1074041|NCT00629707|O1|Outcome|Slow Fluid Infusion|Slower infusion rate: Patients in this arm will receive an initial intravenous fluid bolus of 10cc/Kg followed by rehydration calculated to replace a deficit of 7.5% of body weight over 48 hours.
1074042|NCT00629707|E2|Reported Event|Rapid Fluid Infusion|More rapid infusion: Patients in this arm will receive an initial bolus of 20 cc/Kg of intravenous fluids followed by replacement of an estimated deficit of 10% of body weight over 36 hours plus replacement of 1/2 of urine output volume.
1074043|NCT00629707|E1|Reported Event|Slow Fluid Infusion|Slower infusion rate: Patients in this arm will receive an initial intravenous fluid bolus of 10cc/Kg followed by rehydration calculated to replace a deficit of 7.5% of body weight over 48 hours.
1074044|NCT00629525|B1|Baseline|RAD001|RAD001 at a dose of 10 mg PO daily
1074045|NCT00629525|P1|Participant Flow|RAD001|RAD001 at a dose of 10 mg PO daily
1074046|NCT00629525|O1|Outcome|RAD001|RAD001 at a dose of 10 mg PO daily
1074051|NCT00629525|E1|Reported Event|RAD001|RAD001 at a dose of 10 mg PO daily
1074052|NCT00629499|B1|Baseline|Intervention|100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle) in combination with 600 mg/m2 of IV cyclophosphamide once every 3 weeks for 4 cycles (i.e., a total treatment period of 12 weeks [84 days]). Patients with fluorescence in situ hybridization (FISH) HER2+ or IHC3+ breast cancer will also receive treatment with trastuzumab in addition to the nab paclitaxel / cyclophosphamide combination therapy. Maintenance therapy with trastuzumab will continue (for the HER2+ patients who are receiving trastuzumab) after the 12-week treatment period with combination nab paclitaxel/cyclophosphamide/trastuzumab. The total treatment time for trastuzumab will be 52 weeks rather than only 12 weeks.
1074053|NCT00629499|P1|Participant Flow|Intervention|100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle) in combination with 600 mg/m2 of IV cyclophosphamide once every 3 weeks for 4 cycles (i.e., a total treatment period of 12 weeks [84 days]). Patients with fluorescence in situ hybridization (FISH) HER2+ or IHC3+ breast cancer will also receive treatment with trastuzumab in addition to the nab paclitaxel / cyclophosphamide combination therapy. Maintenance therapy with trastuzumab will continue (for the HER2+ patients who are receiving trastuzumab) after the 12-week treatment period with combination nab paclitaxel/cyclophosphamide/trastuzumab. The total treatment time for trastuzumab will be 52 weeks rather than only 12 weeks.
1074054|NCT00629499|O1|Outcome|Intervention|100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle) in combination with 600 mg/m2 of IV cyclophosphamide once every 3 weeks for 4 cycles (i.e., a total treatment period of 12 weeks [84 days]). Patients with fluorescence in situ hybridization (FISH) HER2+ or IHC3+ breast cancer will also receive treatment with trastuzumab in addition to the nab paclitaxel / cyclophosphamide combination therapy. Maintenance therapy with trastuzumab will continue (for the HER2+ patients who are receiving trastuzumab) after the 12-week treatment period with combination nab paclitaxel/cyclophosphamide/trastuzumab. The total treatment time for trastuzumab will be 52 weeks rather than only 12 weeks.
1074055|NCT00629499|E1|Reported Event|Intervention|100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle) in combination with 600 mg/m2 of IV cyclophosphamide once every 3 weeks for 4 cycles (i.e., a total treatment period of 12 weeks [84 days]). Patients with fluorescence in situ hybridization (FISH) HER2+ or IHC3+ breast cancer will also receive treatment with trastuzumab in addition to the nab paclitaxel / cyclophosphamide combination therapy. Maintenance therapy with trastuzumab will continue (for the HER2+ patients who are receiving trastuzumab) after the 12-week treatment period with combination nab paclitaxel/cyclophosphamide/trastuzumab. The total treatment time for trastuzumab will be 52 weeks rather than only 12 weeks.
1074056|NCT00629265|B3|Baseline|Total|Total of all reporting groups
1074057|NCT00629265|B2|Baseline|Sham NMES Group|Sham NMES combined with exercise therapy
1074058|NCT00629265|B1|Baseline|Active NMES Group|NMES therapy combined with exercise therapy
1074059|NCT00629265|P2|Participant Flow|Sham NMES + Swallowing Exercise|Sham (inactive) NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
1074060|NCT00629265|P1|Participant Flow|Active NMES + Swallowing Exercise|Active NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
1074061|NCT00629265|O2|Outcome|Sham (Inactive) NMES + Swallowing Exercise|Sham (inactive) NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
1074062|NCT00629265|O1|Outcome|Active NMES + Swallowing Exercise|Active NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
1074063|NCT00629265|O2|Outcome|Sham (Inactive) NMES + Swallowing Exercise|Sham (inactive) NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
1074064|NCT00629265|O1|Outcome|Active NMES + Swallowing Exercise|Active NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
1074065|NCT00629265|E2|Reported Event|Sham (Inactive) NMES + Swallowing Exercise|Sham (inactive) NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
1074066|NCT00629265|E1|Reported Event|Active NMES + Swallowing Exercise|Active NMES paired concomitantly with repeated, effortful swallowing exercises, for 60 swallows, 2 times a day, 6 days a week, for 12 weeks.
1074067|NCT00629239|B3|Baseline|Total|Total of all reporting groups
1074068|NCT00629239|B2|Baseline|Placebo|Placebo
1074069|NCT00629239|B1|Baseline|AZD4818|AZD4818 Turbuhaler
1074070|NCT00629239|P2|Participant Flow|Placebo|Placebo
1074071|NCT00629239|P1|Participant Flow|AZD4818|AZD4818 Turbuhaler
1074072|NCT00629239|O2|Outcome|Placebo|Placebo
1074073|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
1074074|NCT00629239|O2|Outcome|Placebo|Placebo
1074075|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
1074076|NCT00629239|O2|Outcome|Placebo|Placebo
1074077|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
1074078|NCT00629239|O2|Outcome|Placebo|Placebo
1074079|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
1074080|NCT00629239|O2|Outcome|Placebo|Placebo
1074081|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
1074082|NCT00629239|O2|Outcome|Placebo|Placebo
1074083|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
1074084|NCT00629239|O2|Outcome|Placebo|Placebo
1074085|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
1074086|NCT00629239|O2|Outcome|Placebo|Placebo
1074087|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
1074088|NCT00629239|O2|Outcome|Placebo|Placebo
1074089|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
1074090|NCT00629239|O2|Outcome|Placebo|Placebo
1074091|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
1074092|NCT00629239|O2|Outcome|Placebo|Placebo
1074093|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
1074094|NCT00629239|O2|Outcome|Placebo|Placebo
1074095|NCT00629239|O1|Outcome|AZD4818|AZD4818 Turbuhaler
1074096|NCT00629239|O2|Outcome|Placebo|Placebo
1074103|NCT00629018|B2|Baseline|Control Group|55 patients were randomized to standard medical therapy, without stem cell injection.
1074104|NCT00629018|B1|Baseline|SC Group|55 patients were randomized to CD34+ cell transplantation (SC group). In the SC group, peripheral CD34+cells were mobilized by G-CSF and collected via apheresis. Patients underwent myocardial scintigraphy and CD34+ cells were injected in the artery supplying the segments with reduced viability
1074105|NCT00629018|P2|Participant Flow|Control Group|55 patients were randomized to standard medical therapy, without stem cell injection.
1074106|NCT00629018|P1|Participant Flow|SC Group|55 patients were randomized to CD34+ cell transplantation (SC group). In the SC group, peripheral CD34+cells were mobilized by G-CSF and collected via apheresis. Patients underwent myocardial scintigraphy and CD34+ cells were injected in the artery supplying the segments with reduced viability
1074107|NCT00629018|O2|Outcome|Control Group|55 patients were randomized to standard medical therapy, without stem cell injection.
1074108|NCT00629018|O1|Outcome|SC Group|55 patients were randomized to CD34+ cell transplantation (SC group). In the SC group, peripheral CD34+cells were mobilized by G-CSF and collected via apheresis. Patients underwent myocardial scintigraphy and CD34+ cells were injected in the artery supplying the segments with reduced viability
1074109|NCT00629018|O2|Outcome|Control Group|55 patients were randomized to standard medical therapy, without stem cell injection.
1074110|NCT00629018|O1|Outcome|SC Group|55 patients were randomized to CD34+ cell transplantation (SC group). In the SC group, peripheral CD34+cells were mobilized by G-CSF and collected via apheresis. Patients underwent myocardial scintigraphy and CD34+ cells were injected in the artery supplying the segments with reduced viability
1074111|NCT00629018|E2|Reported Event|Control Group|55 patients were randomized to standard medical therapy, without stem cell injection.
1074112|NCT00629018|E1|Reported Event|SC Group|55 patients were randomized to CD34+ cell transplantation (SC group). In the SC group, peripheral CD34+cells were mobilized by G-CSF and collected via apheresis. Patients underwent myocardial scintigraphy and CD34+ cells were injected in the artery supplying the segments with reduced viability
1074113|NCT00628927|B3|Baseline|Total|Total of all reporting groups
1074114|NCT00628927|B2|Baseline|Normal Control Participants|Normal Control participants recruited from the community
1074115|NCT00628927|B1|Baseline|Simulant Dependent Participants|Stimulant Dependent pts entering treatment who are also enrolled in CTN0031
1074116|NCT00628927|P2|Participant Flow|Normal Control Participants|Normal Control participants recruited from the community
1074117|NCT00628927|P1|Participant Flow|Simulant Dependent Participants|Stimulant Dependent pts entering treatment who are also enrolled in CTN0031
1074118|NCT00628927|O3|Outcome|Normal Controls|Normal controls recruited from the community.
1074119|NCT00628927|O2|Outcome|Stimulant Dependent Treatment Non-Completers|"Non-completers were those who failed to attend the first 5 weeks of treatment without missing two or more consecutive weeks; alternately, a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment non-completer if s/he did not attend treatment during the sixth week Data for 2 participants who were ineligible but enrolled were removed from analysis 1 participant did not complete the blood draw~1 participant sample was insufficient for analysis"
1074120|NCT00628927|O1|Outcome|Stimulant Dependent Completers|Completers were those who attended the first 5 weeks of treatment without missing two or more consecutive weeks; a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment completer if s/he attended treatment during the sixth week 3 participant samples were insufficient for analysis
1074121|NCT00628927|O2|Outcome|Stimulant Dependent Treatment Non-Completers|"Non-completers were those who failed to attend the first 5 weeks of treatment without missing two or more consecutive weeks; alternately, a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment non-completer if s/he did not attend treatment during the sixth week Data from the two ineligible by enrolled participants was removed from the analysis.~Data from 3 other participants was incomplete and therefore removed from the analysis."
1074122|NCT00628927|O1|Outcome|Stimulant Dependent Completers|Completers were those who attended the first 5 weeks of treatment without missing two or more consecutive weeks; a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment completer if s/he attended treatment during the sixth week Data from one participant was excluded from analysis due to lack of completeness
1074123|NCT00628927|O2|Outcome|Stimulant Dependent Treatment Non-Completers|Non-completers were those who failed to attend the first 5 weeks of treatment without missing two or more consecutive weeks; alternately, a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment non-completer if s/he did not attend treatment during the sixth week Data for the two ineligible but enrolled participants was removed from the analysis.
1074124|NCT00628927|O1|Outcome|Stimulant Dependent Completers|Completers were those who attended the first 5 weeks of treatment without missing two or more consecutive weeks; a participant who attended the first 4 weeks of treatment and missed the fifth week was considered a treatment completer if s/he attended treatment during the sixth week
1074125|NCT00628927|E2|Reported Event|Normal Control Participants|Normal Control participants recruited from the community
1074126|NCT00628927|E1|Reported Event|Simulant Dependent Participants|Stimulant Dependent pts entering treatment who are also enrolled in CTN0031
1074127|NCT00628901|B3|Baseline|Total|Total of all reporting groups
1074128|NCT00628901|B2|Baseline|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
1074129|NCT00628901|B1|Baseline|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
1074130|NCT00628901|P2|Participant Flow|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
1074131|NCT00628901|P1|Participant Flow|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
1074132|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
1074133|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
1074134|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
1074135|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
1074136|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
1074137|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
1074138|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
1074139|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
1074140|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
1074141|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
1074142|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
1074143|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
1074144|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
1074145|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
1074146|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
1074147|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
1074148|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
1074149|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
1074150|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
1074151|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
1074152|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
1074153|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
1074154|NCT00628901|O2|Outcome|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
1074155|NCT00628901|O1|Outcome|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
1074156|NCT00628901|E2|Reported Event|Embosphere Microspheres|Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
1074157|NCT00628901|E1|Reported Event|Contour SE Microspheres|Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations
1074158|NCT00628862|B4|Baseline|Total|Total of all reporting groups
1074159|NCT00628862|B3|Baseline|Placebo|Placebo
1074163|NCT00628862|P2|Participant Flow|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
1074164|NCT00628862|P1|Participant Flow|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
1074165|NCT00628862|O3|Outcome|Placebo|Placebo
1074166|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
1074167|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
1074168|NCT00628862|O3|Outcome|Placebo|Placebo
1074169|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
1074170|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
1074171|NCT00628862|O3|Outcome|Placebo|Placebo
1074172|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
1074173|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
1074174|NCT00628862|O3|Outcome|Placebo|Placebo
1074175|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
1074176|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
1074177|NCT00628862|O3|Outcome|Placebo|Placebo
1074178|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
1074179|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
1074180|NCT00628862|O3|Outcome|Placebo|Placebo
1074181|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
1074182|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
1074183|NCT00628862|O3|Outcome|Placebo|Placebo
1074184|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
1074185|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
1074186|NCT00628862|O3|Outcome|Placebo|Placebo
1074187|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
1074188|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
1074189|NCT00628862|O3|Outcome|Placebo|Placebo
1074190|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
1074191|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
1074192|NCT00628862|O3|Outcome|Placebo|Placebo
1074193|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
1074194|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
1074195|NCT00628862|O3|Outcome|Placebo|Placebo
1074196|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
1074197|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
1074198|NCT00628862|O3|Outcome|Placebo|Placebo
1074199|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
1074200|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
1074201|NCT00628862|O3|Outcome|Placebo|Placebo
1074202|NCT00628862|O2|Outcome|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
1074203|NCT00628862|O1|Outcome|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
1074204|NCT00628862|E3|Reported Event|Placebo|Placebo
1074205|NCT00628862|E2|Reported Event|Formoterol 9.0 Bid|Formoterol 9.0 ug bid
1074206|NCT00628862|E1|Reported Event|Formoterol 4.5 Bid|Formoterol 4.5 ug bid
1074207|NCT00628758|B3|Baseline|Total|Total of all reporting groups
1074208|NCT00628758|B2|Baseline|Conventional BP|Conventional Best Practice for Treatment of asthma
1074209|NCT00628758|B1|Baseline|Symbicort|Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
1074210|NCT00628758|P2|Participant Flow|Conventional BP|Conventional Best Practice for Treatment of asthma
1074211|NCT00628758|P1|Participant Flow|Symbicort|Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
1074212|NCT00628758|O2|Outcome|Conventional BP|Conventional Best Practice for Treatment of asthma
1074213|NCT00628758|O1|Outcome|Symbicort|Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
1074214|NCT00628758|O2|Outcome|Conventional BP|Conventional Best Practice for Treatment of asthma
1074215|NCT00628758|O1|Outcome|Symbicort|Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
1074216|NCT00628758|O2|Outcome|Conventional BP|Conventional Best Practice for Treatment of asthma
1074217|NCT00628758|O1|Outcome|Symbicort|Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
1074218|NCT00628758|O2|Outcome|Conventional Best Practice (BP)|Conventional Best Practice for Treatment of asthma
1074219|NCT00628758|O1|Outcome|Symbicort|Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microgram (microg), 1 inh bid + as need)
1074220|NCT00628758|E2|Reported Event|Conventional BP|Conventional Best Practice for Treatment of asthma
1074221|NCT00628758|E1|Reported Event|Symbicort|Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
1074222|NCT00628628|B3|Baseline|Total|Total of all reporting groups
1074223|NCT00628628|B2|Baseline|Group B: Daily Dose|Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily
1074224|NCT00628628|B1|Baseline|Group A: Single Dose|As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.
1074225|NCT00628628|P2|Participant Flow|Group B: Daily Dose|Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily
1074226|NCT00628628|P1|Participant Flow|Group A: Single Dose|As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.
1074227|NCT00628628|O2|Outcome|Group B: Daily Dose|Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily
1074228|NCT00628628|O1|Outcome|Group A: Single Dose|As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.
1074229|NCT00628628|E2|Reported Event|Group B: Daily Dose|Fixed Dose Rasburicase .15 mg/kg IV Over 30 Minutes Daily
1074230|NCT00628628|E1|Reported Event|Group A: Single Dose|As Needed Rasburicase .15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.
1074231|NCT00628446|B1|Baseline|Study Group|
1074232|NCT00628446|P1|Participant Flow|Study Group|
1074233|NCT00628446|O1|Outcome|Group 1|
1074234|NCT00628446|O1|Outcome|Study Group|Cross-sectional study group
1074235|NCT00628446|E1|Reported Event|Study Group|
1074236|NCT00628407|B1|Baseline|Sternal Wall Pressure|
1074299|NCT00628212|B1|Baseline|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
1074237|NCT00628407|P1|Participant Flow|Sternal Wall Pressure|Subjects that received gentle incremental sternal wall pressure.
1074238|NCT00628407|O1|Outcome|Sternal Wall Pressure|
1074239|NCT00628407|E1|Reported Event|Sternal Wall Pressure|
1074240|NCT00628355|B3|Baseline|Total|Total of all reporting groups
1074241|NCT00628355|B2|Baseline|Anesthesia Injection|group received lidocaine injections once a week for 4 weeks
1074242|NCT00628355|B1|Baseline|Ischemic Compression|Group received TENS plus Ischemic compression
1074243|NCT00628355|P2|Participant Flow|Anesthesia Injection|Group received lidocaine injection
1074244|NCT00628355|P1|Participant Flow|TENS Plus Ischemic Compression|Group received TENS plus ischemic compression
1074245|NCT00628355|O2|Outcome|Anesthesia Injection|Group received lidocaine injection
1074246|NCT00628355|O1|Outcome|TENS Plus Ischemic Compression|Group received TENS plus ischemic compression
1074247|NCT00628355|O2|Outcome|Anesthesia Injection|Group received lidocaine injection
1074248|NCT00628355|O1|Outcome|Ischemic Compression|Group received ischemic compression
1074249|NCT00628355|E2|Reported Event|Anesthesia Injection|group received lidocaine injections once a week for 4 weeks
1074250|NCT00628355|E1|Reported Event|Ischemic Compression|Group received Ischemic compression
1074251|NCT00628251|B4|Baseline|Total|Total of all reporting groups
1074252|NCT00628251|B3|Baseline|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
1074253|NCT00628251|B2|Baseline|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
1074254|NCT00628251|B1|Baseline|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
1074255|NCT00628251|P3|Participant Flow|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
1074256|NCT00628251|P2|Participant Flow|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
1074257|NCT00628251|P1|Participant Flow|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
1074258|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
1074259|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
1074260|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
1074261|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
1074262|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
1074263|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
1074264|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
1074265|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
1074266|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
1074267|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
1074268|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
1074269|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
1074270|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
1074271|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
1074272|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
1074273|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
1074274|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
1074275|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
1074276|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
1074277|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
1074278|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
1074279|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
1074280|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
1074281|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
1074282|NCT00628251|O4|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
1074283|NCT00628251|O3|Outcome|Olaparib 200 mg bd + Olaparib 400 mg bd,|Olaparib (AZD2281) 200 or 400 mg oral capsules twice daily
1074284|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
1074285|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
1074286|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
1074287|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
1074288|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
1074289|NCT00628251|O3|Outcome|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
1074290|NCT00628251|O2|Outcome|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
1074291|NCT00628251|O1|Outcome|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
1074292|NCT00628251|E3|Reported Event|Liposomal Doxorubicin|Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
1074293|NCT00628251|E2|Reported Event|Olaparib 400 mg bd|Olaparib (AZD2281) 400 mg oral capsules twice daily
1074294|NCT00628251|E1|Reported Event|Olaparib 200 mg bd|Olaparib (AZD2281) 200 mg oral capsules twice daily
1074295|NCT00628212|B5|Baseline|Total|Total of all reporting groups
1074296|NCT00628212|B4|Baseline|Teneligliptin 40 mg|Teneligliptin 40 mg, orally, once daily
1074297|NCT00628212|B3|Baseline|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
1074298|NCT00628212|B2|Baseline|Teneligliptin 10 mg|Teneligliptin 10 mg, orally, once daily
1074300|NCT00628212|P4|Participant Flow|Teneligliptin 40 mg|Teneligliptin 40 mg, orally, once daily
1074301|NCT00628212|P3|Participant Flow|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
1074302|NCT00628212|P2|Participant Flow|Teneligliptin 10 mg|Teneligliptin 10 mg, orally, once daily
1074303|NCT00628212|P1|Participant Flow|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
1074304|NCT00628212|O4|Outcome|Teneligliptin 40 mg|Teneligliptin 40 mg, orally, once daily
1074305|NCT00628212|O3|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
1074306|NCT00628212|O2|Outcome|Teneligliptin 10 mg|Teneligliptin 10 mg, orally, once daily
1074307|NCT00628212|O1|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
1074308|NCT00628212|O4|Outcome|Teneligliptin 40 mg|Teneligliptin 40 mg, orally, once daily
1074309|NCT00628212|O3|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
1074310|NCT00628212|O2|Outcome|Teneligliptin 10 mg|Teneligliptin 10 mg, orally, once daily
1074311|NCT00628212|O1|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
1074312|NCT00628212|O4|Outcome|Teneligliptin 40 mg|Teneligliptin 40 mg, orally, once daily
1074313|NCT00628212|O3|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
1074314|NCT00628212|O2|Outcome|Teneligliptin 10 mg|Teneligliptin 10 mg, orally, once daily
1074315|NCT00628212|O1|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
1074316|NCT00628212|O4|Outcome|Teneligliptin 40 mg|Teneligliptin 40 mg, orally, once daily
1074317|NCT00628212|O3|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
1074318|NCT00628212|O2|Outcome|Teneligliptin 10 mg|Teneligliptin 10 mg, orally, once daily
1074319|NCT00628212|O1|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
1074320|NCT00628212|E4|Reported Event|Teneligliptin 40 mg|Teneligliptin 40 mg, orally, once daily
1074321|NCT00628212|E3|Reported Event|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
1074322|NCT00628212|E2|Reported Event|Teneligliptin 10 mg|Teneligliptin 10 mg, orally, once daily
1074323|NCT00628212|E1|Reported Event|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
1074324|NCT00628147|B3|Baseline|Total|Total of all reporting groups
1074325|NCT00628147|B2|Baseline|White Light|Conventional White Light Examination
1074326|NCT00628147|B1|Baseline|Narrow Band Imaging Colonoscope|Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.
1074327|NCT00628147|P2|Participant Flow|White Light|Conventional White Light Examination
1074328|NCT00628147|P1|Participant Flow|Narrow Band Imaging Colonoscope|Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.
1074329|NCT00628147|O2|Outcome|White Light|Conventional White Light Examination
1074330|NCT00628147|O1|Outcome|Narrow Band Imaging Colonoscope|Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.
1074331|NCT00628147|O2|Outcome|White Light|Conventional White Light Examination
1074332|NCT00628147|O1|Outcome|Narrow Band Imaging Colonoscope|Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.
1074333|NCT00628147|O2|Outcome|White Light|Conventional White Light Examination
1074334|NCT00628147|O1|Outcome|Narrow Band Imaging Colonoscope|Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.
1074335|NCT00628147|O2|Outcome|White Light|Conventional White Light Examination
1074336|NCT00628147|O1|Outcome|Narrow Band Imaging Colonoscope|Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.
1074337|NCT00628147|E2|Reported Event|White Light|Conventional White Light Examination
1074338|NCT00628147|E1|Reported Event|Narrow Band Imaging Colonoscope|Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.
1074339|NCT00628134|B1|Baseline|Cystic Fibrosis Subjects|"Subjects with cystic fibrosis~isotonic saline aerosol : single inhaled dose, 3ml by nebulizer~calfactant aerosol : single inhaled dose, 3ml by nebulizer"
1074340|NCT00628134|P2|Participant Flow|Saline Aerosol Then Surfactant Aerosol|cystic fibrosis patients who inhaled saline aerosol at the first study visit and surfactant aerosol at the second study visit
1074341|NCT00628134|P1|Participant Flow|Surfactant Aerosol Then Saline Aerosol|cystic fibrosis patients who inhaled surfactant aerosol at the first study visit and saline aerosol at the second study visit
1074342|NCT00628134|O2|Outcome|Subjects Inhaling Surfactant|Subjects with cystic fibrosis
1074343|NCT00628134|O1|Outcome|Subjects Inhaling Saline|Subjects with cystic fibrosis
1074344|NCT00628134|O2|Outcome|Subjects Inhaling Surfactant|Subjects with cystic fibrosis
1074345|NCT00628134|O1|Outcome|Subjects Inhaling Saline|Subjects with cystic fibrosis
1074346|NCT00628134|E2|Reported Event|Subjects Inhaling Surfactant|Subjects with cystic fibrosis
1074347|NCT00628134|E1|Reported Event|Subjects Inhaling Saline|Subjects with cystic fibrosis
1074348|NCT00628108|B3|Baseline|Total|Total of all reporting groups
1074349|NCT00628108|B2|Baseline|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1074350|NCT00628108|B1|Baseline|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1074351|NCT00628108|P2|Participant Flow|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1074352|NCT00628108|P1|Participant Flow|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1074353|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1074354|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1074355|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1074356|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1074357|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1074358|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1074359|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1074360|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1074361|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1074362|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1074363|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1074364|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1074365|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1074366|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1074367|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1074368|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1074369|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1074370|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1074371|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1074372|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1074373|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1074374|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1074375|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1074376|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1074377|NCT00628108|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1074378|NCT00628108|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1074379|NCT00628108|E2|Reported Event|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1074380|NCT00628108|E1|Reported Event|Placebo|Placebo (5 drops) dosed by mouth in the morning at breakfast time once a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1074381|NCT00628030|B3|Baseline|Total|Total of all reporting groups
1074382|NCT00628030|B2|Baseline|Wellness Group|Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
1074383|NCT00628030|B1|Baseline|NOURISH|Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
1074384|NCT00628030|P2|Participant Flow|Wellness Group|Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
1074385|NCT00628030|P1|Participant Flow|NOURISH|Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
1074386|NCT00628030|O2|Outcome|Wellness Group|Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
1074387|NCT00628030|O1|Outcome|NOURISH|Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
1074388|NCT00628030|O2|Outcome|Wellness Group|Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
1074389|NCT00628030|O1|Outcome|NOURISH|Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
1074455|NCT00627705|B1|Baseline|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine~N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
1075885|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
1074390|NCT00628030|O2|Outcome|Wellness Group|Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
1074391|NCT00628030|O1|Outcome|NOURISH|Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
1074392|NCT00628030|O2|Outcome|Wellness Group|Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
1074393|NCT00628030|O1|Outcome|NOURISH|Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
1074394|NCT00628030|O2|Outcome|Wellness Group|Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.
1074395|NCT00628030|O1|Outcome|NOURISH|Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
1074396|NCT00628030|E2|Reported Event|Wellness Group|The placebo control group attended a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, parents received pedometers for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were sent home one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing.Followed up for 6 months.
1074397|NCT00628030|E1|Reported Event|NOURISH|The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. The interventions differed only in duration. They covered the same concepts which are grounded in Social Cognitive Theory (SCT). Throughout the interventions the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics provided information about implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions.
1074398|NCT00627926|B4|Baseline|Total|Total of all reporting groups
1074399|NCT00627926|B3|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
1074400|NCT00627926|B2|Baseline|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
1074401|NCT00627926|B1|Baseline|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
1074551|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
1074665|NCT00627094|B1|Baseline|Biatain Ibu|Biatain foam dressing containing ibuprofen
1074402|NCT00627926|P3|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
1074403|NCT00627926|P2|Participant Flow|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
1074404|NCT00627926|P1|Participant Flow|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
1074405|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
1074406|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
1074407|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
1074408|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
1074409|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
1074410|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
1074411|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
1074412|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
1074413|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
1074414|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
1074415|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
1074416|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
1074417|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
1075886|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
1074418|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
1074419|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
1074420|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
1074421|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
1074422|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
1074423|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
1074424|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
1074425|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
1074426|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
1074427|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
1074428|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
1074429|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
1074430|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
1074431|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
1074432|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
1074433|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
1074434|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
1074435|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
1074436|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
1074437|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
1074438|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
1074439|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
1074440|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
1074441|NCT00627926|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
1074442|NCT00627926|O2|Outcome|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
1074443|NCT00627926|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
1074444|NCT00627926|E3|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
1074445|NCT00627926|E2|Reported Event|Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week|Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
1074446|NCT00627926|E1|Reported Event|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
1074447|NCT00627861|B1|Baseline|Aliskiren and Metoprolol|Aliskiren was administered for 4 weeks and then Metoprol was added for 2 additional weeks of treatment.
1074448|NCT00627861|P1|Participant Flow|Aliskiren and Metoprolol|Aliskiren was administered for 4 weeks and then Metoprol was added for 2 additional weeks of treatment.
1074449|NCT00627861|O1|Outcome|Aliskiren and Metoprolol|Aliskiren was administered for 4 weeks and then Metoprol was added for an additional 2 weeks
1074450|NCT00627861|O1|Outcome|Aliskiren and Metoprolol|Aliskiren was administered for 4 weeks and then Metoprol was added for an additional 2 weeks.
1074451|NCT00627861|O1|Outcome|Aliskiren and Metoprolol|Aliskiren was administered for 4 weeks and then Metoprol was added for 2 additional weeks of treatment.
1074452|NCT00627861|E1|Reported Event|Aliskiren and Metoprolol|Aliskiren was administered for 4 weeks and then Metoprol was added for 2 additional weeks of treatment.
1074453|NCT00627705|B3|Baseline|Total|Total of all reporting groups
1074454|NCT00627705|B2|Baseline|Sugar Pill|"Placebo or sugar pill~Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
1074456|NCT00627705|P2|Participant Flow|Sugar Pill|"Placebo or sugar pill~Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
1074457|NCT00627705|P1|Participant Flow|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine~N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
1074458|NCT00627705|O2|Outcome|Sugar Pill|"Placebo or sugar pill~Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
1074459|NCT00627705|O1|Outcome|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine~N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
1074460|NCT00627705|O2|Outcome|Sugar Pill|"Placebo or sugar pill~Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
1074461|NCT00627705|O1|Outcome|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine~N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
1074462|NCT00627705|O2|Outcome|Sugar Pill|"Placebo or sugar pill~Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
1074463|NCT00627705|O1|Outcome|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine~N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
1074464|NCT00627705|O2|Outcome|Sugar Pill|"Placebo or sugar pill~Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
1074465|NCT00627705|O1|Outcome|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine~N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
1074466|NCT00627705|O2|Outcome|Sugar Pill|"Placebo or sugar pill~Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
1074467|NCT00627705|O1|Outcome|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine~N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
1074468|NCT00627705|O2|Outcome|Sugar Pill|"Placebo or sugar pill~Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
1074469|NCT00627705|O1|Outcome|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine~N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
1074470|NCT00627705|O2|Outcome|Sugar Pill|"Placebo or sugar pill~Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
1074471|NCT00627705|O1|Outcome|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine~N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
1074472|NCT00627705|O2|Outcome|Sugar Pill|"Placebo or sugar pill~Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
1074473|NCT00627705|O1|Outcome|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine~N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
1074474|NCT00627705|E2|Reported Event|Sugar Pill|"Placebo or sugar pill~Placebo - sugar pill: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
1074475|NCT00627705|E1|Reported Event|N-Acetyl Cysteine|"active compound N-Acetyl Cysteine~N-Acetyl Cysteine: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks~Entire intervention lasts for 12 weeks (drug administration is continuous)."
1074476|NCT00627679|B1|Baseline|All Patients|All patients that were enrolled in the study.
1074477|NCT00627679|P4|Participant Flow|Treatment D, A, C, B|Treatment visits were separated by a 48-72 hour washout period. Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 2; Treatment A = a single dose of Pulmicort Respules® delivered by nebulization at Visit 3; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 4; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 5
1074478|NCT00627679|P3|Participant Flow|Treatment C, D, B, A|Treatment visits were separated by a 48-72 hour washout period. Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 2; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 3; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 4; Treatment A = a single dose of Pulmicort Respules® delivered by nebulization at Visit 5
1074552|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
1074479|NCT00627679|P2|Participant Flow|Treatment B, C, A, D|Treatment visits were separated by a 48-72 hour washout period. Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 2; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 3; Treatment A = a single dose of Pulmicort Respules® delivered by nebulization at Visit 4; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 5
1074480|NCT00627679|P1|Participant Flow|Treatment A, B, D, C|Treatment visits were separated by a 48-72 hour washout period. Treatment A = a single dose of Pulmicort Respules® delivered by nebulization at Visit 2; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 3; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 4; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 5
1074481|NCT00627679|O4|Outcome|Treatment D|a single dose of MAP0010 high dose delivered by nebulization as per protocol
1074482|NCT00627679|O3|Outcome|Treatment C|a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol
1074483|NCT00627679|O2|Outcome|Treatment B|a single dose of MAP0010 low dose delivered by nebulization as per protocol
1074484|NCT00627679|O1|Outcome|Treatment A|a single dose of Pulmicort Respules® delivered by nebulization as per protocol
1074485|NCT00627679|O4|Outcome|Treatment D|a single dose of MAP0010 high dose delivered by nebulization as per protocol
1074486|NCT00627679|O3|Outcome|Treatment C|a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol
1074487|NCT00627679|O2|Outcome|Treatment B|a single dose of MAP0010 low dose delivered by nebulization as per protocol
1074488|NCT00627679|O1|Outcome|Treatment A|a single dose of Pulmicort Respules® delivered by nebulization as per protocol
1074489|NCT00627679|O4|Outcome|Treatment D|a single dose of MAP0010 high dose delivered by nebulization as per protocol
1074490|NCT00627679|O3|Outcome|Treatment C|a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol
1074491|NCT00627679|O2|Outcome|Treatment B|a single dose of MAP0010 low dose delivered by nebulization as per protocol
1074492|NCT00627679|O1|Outcome|Treatment A|a single dose of Pulmicort Respules® delivered by nebulization as per protocol
1074493|NCT00627679|O4|Outcome|Treatment D|a single dose of MAP0010 high dose delivered by nebulization as per protocol
1074494|NCT00627679|O3|Outcome|Treatment C|a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol
1074495|NCT00627679|O2|Outcome|Treatment B|a single dose of MAP0010 low dose delivered by nebulization as per protocol
1074496|NCT00627679|O1|Outcome|Treatment A|a single dose of Pulmicort Respules® delivered by nebulization as per protocol
1074497|NCT00627679|O4|Outcome|Treatment D|a single dose of MAP0010 high dose delivered by nebulization as per protocol
1074498|NCT00627679|O3|Outcome|Treatment C|a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol
1074499|NCT00627679|O2|Outcome|Treatment B|a single dose of MAP0010 low dose delivered by nebulization as per protocol
1074500|NCT00627679|O1|Outcome|Treatment A|a single dose of Pulmicort Respules® delivered by nebulization as per protocol
1074501|NCT00627679|E4|Reported Event|Treatment D|a single dose of MAP0010 high dose delivered by nebulization as per protocol
1074502|NCT00627679|E3|Reported Event|Treatment C|a single dose of MAP0010 intermediate dose delivered by nebulization as per protocol
1074503|NCT00627679|E2|Reported Event|Treatment B|a single dose of MAP0010 low dose delivered by nebulization as per protocol
1074504|NCT00627679|E1|Reported Event|Treatment A|a single dose of Pulmicort Respules® delivered by nebulization as per protocol
1074505|NCT00627523|B3|Baseline|Total|Total of all reporting groups
1074506|NCT00627523|B2|Baseline|Control|This group was the untreated control group and was not administered placebo.
1074507|NCT00627523|B1|Baseline|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
1074508|NCT00627523|P2|Participant Flow|Control|This group was the untreated control group and was not administered placebo.
1074509|NCT00627523|P1|Participant Flow|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
1074510|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
1074511|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
1074512|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
1074513|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
1074514|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
1074515|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
1074516|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
1075887|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
1074517|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
1074518|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
1074519|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
1074520|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
1074521|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
1074522|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
1074523|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
1074524|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
1074525|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
1074526|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
1074527|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
1074528|NCT00627523|O2|Outcome|Control|This group was the untreated control group and was not administered placebo.
1074529|NCT00627523|O1|Outcome|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
1074530|NCT00627523|E2|Reported Event|Control|This group was the untreated control group and was not administered placebo.
1074531|NCT00627523|E1|Reported Event|Genotropin®|Participants received Genotropin® at a dose of 0.035 mg/kg/d for 24 months. The dose was calculated based on the actual body weight, and the closest dosing step of the 5 mg pen used. The starting dose for the first 2 weeks was 1/3 of the calculated dose. After 2 weeks the dose was increased to 2/3 of the calculated dose. After 4 weeks the daily dose was the dose calculated on body weight at randomization.
1074532|NCT00627497|B5|Baseline|Total|Total of all reporting groups
1074533|NCT00627497|B4|Baseline|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
1074534|NCT00627497|B3|Baseline|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
1074535|NCT00627497|B2|Baseline|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
1074536|NCT00627497|B1|Baseline|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
1074537|NCT00627497|P4|Participant Flow|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
1074538|NCT00627497|P3|Participant Flow|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
1074539|NCT00627497|P2|Participant Flow|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
1074540|NCT00627497|P1|Participant Flow|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
1074541|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
1074542|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
1074543|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
1074544|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
1074545|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
1074546|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
1074547|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
1074548|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
1074549|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
1074550|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
1074553|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
1074554|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
1074555|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
1074556|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
1074557|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
1074558|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
1074559|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
1074560|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
1074561|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
1074562|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
1074563|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
1074564|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
1074565|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
1074566|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
1074567|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
1074568|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
1074569|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
1074570|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
1074571|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
1074572|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
1074573|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
1074574|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
1074575|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
1074576|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
1074577|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
1074578|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
1074579|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
1074580|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
1074581|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
1074582|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
1074583|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
1074584|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
1074585|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
1074586|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
1074587|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
1074588|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
1074589|NCT00627497|O4|Outcome|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
1074590|NCT00627497|O3|Outcome|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
1074591|NCT00627497|O2|Outcome|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
1074592|NCT00627497|O1|Outcome|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
1074593|NCT00627497|E4|Reported Event|Posterolateral Interbody Fusion|Patients in this group received a posterolateral interbody fusion.
1074594|NCT00627497|E3|Reported Event|DIAM Group2|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
1074595|NCT00627497|E2|Reported Event|Single-Level Posterior Decompression|Patients in this group received a single-level posterior lumbar decompression
1074596|NCT00627497|E1|Reported Event|DIAM Group1|Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.
1074597|NCT00627445|B3|Baseline|Total|Total of all reporting groups
1074598|NCT00627445|B2|Baseline|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
1074662|NCT00627393|E1|Reported Event|Control Arm|Received antimicrobial therapy alone.
1074663|NCT00627094|B3|Baseline|Total|Total of all reporting groups
1074599|NCT00627445|B1|Baseline|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
1074600|NCT00627445|P2|Participant Flow|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
1074601|NCT00627445|P1|Participant Flow|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
1074602|NCT00627445|O2|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
1074603|NCT00627445|O1|Outcome|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
1074604|NCT00627445|O2|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
1074605|NCT00627445|O1|Outcome|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
1074606|NCT00627445|O2|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
1074607|NCT00627445|O1|Outcome|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
1074608|NCT00627445|O2|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
1074609|NCT00627445|O1|Outcome|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
1074610|NCT00627445|O2|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
1074611|NCT00627445|O1|Outcome|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
1074612|NCT00627445|O2|Outcome|BIAsp 30-30|Individually adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin (500-2000 mg up to three times daily)
1074613|NCT00627445|O1|Outcome|BIAsp 50-50-30|Individually adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch in combination with metformin (500-2000 mg up to three times daily)
1074614|NCT00627445|O2|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
1074615|NCT00627445|O1|Outcome|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
1074616|NCT00627445|O2|Outcome|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
1074617|NCT00627445|O1|Outcome|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
1074618|NCT00627445|E2|Reported Event|BIAsp 30-30|Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 500-2000 mg, up to three times daily
1074619|NCT00627445|E1|Reported Event|BIAsp 50-50-30|Individual adjusted dose of biphasic insulin aspart 50 administered before breakfast and lunch and individual adjusted dose of biphasic insulin aspart 30 at dinner in combination with metformin 500-2000 mg, up to three times daily
1074620|NCT00627406|B5|Baseline|Total|Total of all reporting groups
1074621|NCT00627406|B4|Baseline|D: <15 Follicles; hCG Trigger|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
1074622|NCT00627406|B3|Baseline|C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)~Buserelin and Pregnyl : Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days"
1074623|NCT00627406|B2|Baseline|B: >14 Follicles; hCG Trigger|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
1074624|NCT00627406|B1|Baseline|A: >14 Follicles; GnRHa Trigger + 1500 hCG|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)~Buserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU"
1074625|NCT00627406|P4|Participant Flow|D: <15 Follicles; hCG Trigger|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
1074626|NCT00627406|P3|Participant Flow|C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)~Buserelin and Pregnyl : Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days"
1074627|NCT00627406|P2|Participant Flow|B: >14 Follicles; hCG Trigger|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
1074664|NCT00627094|B2|Baseline|Biatain|Biatain foam dressing without ibuprofen - control
1075888|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
1074628|NCT00627406|P1|Participant Flow|A: >14 Follicles; GnRHa Trigger + 1500 hCG|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)~Buserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU"
1074629|NCT00627406|O4|Outcome|D: <15 Follicles; hCG Trigger|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
1074630|NCT00627406|O3|Outcome|C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)~Buserelin and Pregnyl : Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days"
1074631|NCT00627406|O2|Outcome|B: >14 Follicles; hCG Trigger|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
1074632|NCT00627406|O1|Outcome|A: >14 Follicles; GnRHa Trigger + 1500 hCG|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)~Buserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU"
1074633|NCT00627406|O4|Outcome|D: <15 Follicles; hCG Trigger|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
1074634|NCT00627406|O3|Outcome|C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)~Buserelin and Pregnyl : Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days"
1074635|NCT00627406|O2|Outcome|B: >14 Follicles; hCG Trigger|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
1074636|NCT00627406|O1|Outcome|A: >14 Follicles; GnRHa Trigger + 1500 hCG|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)~Buserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU"
1074637|NCT00627406|E4|Reported Event|D: <15 Follicles; hCG Trigger|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
1074638|NCT00627406|E3|Reported Event|C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2|"14 or less follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)~Buserelin and Pregnyl : Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days"
1074639|NCT00627406|E2|Reported Event|B: >14 Follicles; hCG Trigger|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)~Pregnyl : Subcutaneous injection 5000 IU"
1074640|NCT00627406|E1|Reported Event|A: >14 Follicles; GnRHa Trigger + 1500 hCG|"More than 14 follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)~Buserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU"
1074641|NCT00627393|B3|Baseline|Total|Total of all reporting groups
1074642|NCT00627393|B2|Baseline|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
1074643|NCT00627393|B1|Baseline|Control Arm|Received antimicrobial therapy alone.
1074644|NCT00627393|P2|Participant Flow|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
1074645|NCT00627393|P1|Participant Flow|Control Arm|Received antimicrobial therapy alone.
1074646|NCT00627393|O1|Outcome|Granulocyte Donors|"Participants will donate granulocytes after receiving a combination of two drugs, G-CSF and dexamethasone~G-CSF/dexamethasone: Twelve hours before each donation, participants will be injected with G-CSF and will take one dose of dexamethasone by mouth.~Apheresis machine: Participants will undergo a procedure using an apheresis machine for granulocyte collection. The procedure will last 3 to 4 hours and will involve the drawing of blood from each arm, the separation of granulocytes from the red cells and plasma in the machine, and the return of the red cells and plasma to the participants."
1074647|NCT00627393|O1|Outcome|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
1074648|NCT00627393|O1|Outcome|Granulocyte Donors|"Participants will donate granulocytes after receiving a combination of two drugs, G-CSF and dexamethasone~G-CSF/dexamethasone: Twelve hours before each donation, participants will be injected with G-CSF and will take one dose of dexamethasone by mouth.~Apheresis machine: Participants will undergo a procedure using an apheresis machine for granulocyte collection. The procedure will last 3 to 4 hours and will involve the drawing of blood from each arm, the separation of granulocytes from the red cells and plasma in the machine, and the return of the red cells and plasma to the participants."
1074649|NCT00627393|O2|Outcome|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
1074650|NCT00627393|O1|Outcome|Control Arm|Received antimicrobial therapy alone.
1074651|NCT00627393|O2|Outcome|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
1074652|NCT00627393|O1|Outcome|Control Arm|Received antimicrobial therapy alone.
1074653|NCT00627393|O2|Outcome|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
1074654|NCT00627393|O1|Outcome|Control Arm|Received antimicrobial therapy alone.
1074655|NCT00627393|O2|Outcome|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
1074656|NCT00627393|O1|Outcome|Control Arm|Received antimicrobial therapy alone.
1074657|NCT00627393|O2|Outcome|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
1074658|NCT00627393|O1|Outcome|Control Arm|Received antimicrobial therapy alone.
1074659|NCT00627393|O2|Outcome|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
1074660|NCT00627393|O1|Outcome|Control Arm|Received antimicrobial therapy alone.
1074661|NCT00627393|E2|Reported Event|Granulocyte Arm|Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
1074666|NCT00627094|P2|Participant Flow|Biatain|Biatain Foam dressing without ibuprofen - control
1074667|NCT00627094|P1|Participant Flow|Biatain Ibu|Biatain foam dressing containing Ibuprofen
1074668|NCT00627094|O2|Outcome|Biatain|Biatain Foam dressing without ibuprofen - control
1074669|NCT00627094|O1|Outcome|Biatain Ibu|Biatain foam dressing containing Ibuprofen
1074670|NCT00627094|O2|Outcome|Biatain|Biatain Foam dressing without ibuprofen - control
1074671|NCT00627094|O1|Outcome|Biatain Ibu|Biatain foam dressing containing Ibuprofen
1074672|NCT00627094|O2|Outcome|Biatain|Biatain Foam dressing without ibuprofen - control
1074673|NCT00627094|O1|Outcome|Biatain Ibu|Biatain foam dressing containing Ibuprofen
1074674|NCT00627094|O2|Outcome|Biatain|Biatain foam dressing without ibuprofen - control
1074675|NCT00627094|O1|Outcome|Biatain Ibu|Biatain foam dressing containing ibuprofen
1074676|NCT00627094|E2|Reported Event|Biatain|Biatain foam dressing without ibuprofen
1074677|NCT00627094|E1|Reported Event|Biatain Ibu|Biatain foam dressing containing ibuprofen
1074678|NCT00627042|B1|Baseline|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
1074679|NCT00627042|P1|Participant Flow|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
1074680|NCT00627042|O1|Outcome|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
1074681|NCT00627042|O1|Outcome|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
1074682|NCT00627042|O1|Outcome|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
1074683|NCT00627042|O1|Outcome|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
1074684|NCT00627042|O1|Outcome|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
1074685|NCT00627042|O1|Outcome|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
1074686|NCT00627042|O1|Outcome|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
1074687|NCT00627042|E1|Reported Event|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered intravenously over 1 hour, every 2 weeks. Treatment continued until there was evidence of disease progression, intolerable toxicity, or other withdrawal criteria were met.
1074688|NCT00627016|B3|Baseline|Total|Total of all reporting groups
1074689|NCT00627016|B2|Baseline|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
1074690|NCT00627016|B1|Baseline|Placebo|Placebo capsules, orally, once daily for up to 4 weeks.
1074691|NCT00627016|P2|Participant Flow|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
1074692|NCT00627016|P1|Participant Flow|Placebo|Placebo capsules, orally, once daily for up to 4 weeks.
1074693|NCT00627016|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
1074694|NCT00627016|O1|Outcome|Placebo|Placebo capsules, orally, once daily for up to 4 weeks.
1074695|NCT00627016|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
1074696|NCT00627016|O1|Outcome|Placebo|Placebo capsules, orally, once daily for up to 4 weeks.
1074697|NCT00627016|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
1074698|NCT00627016|O1|Outcome|Placebo|Placebo capsules, orally, once daily for up to 4 weeks.
1074699|NCT00627016|E2|Reported Event|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
1074700|NCT00627016|E1|Reported Event|Placebo|Placebo capsules, orally, once daily for up to 4 weeks.
1074701|NCT00626925|B3|Baseline|Total|Total of all reporting groups
1074702|NCT00626925|B2|Baseline|Total Placebo Group|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
1074703|NCT00626925|B1|Baseline|Total Topiramate Group|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
1074704|NCT00626925|P2|Participant Flow|Placebo|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
1074705|NCT00626925|P1|Participant Flow|Active Med|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
1074706|NCT00626925|O2|Outcome|Placebo Group|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
1075530|NCT00624559|B4|Baseline|Placebo, High Sodium|Placebo pill taken twice per day over the course of the diet
1074707|NCT00626925|O1|Outcome|Active Med|"Topiramate (up to 200 mg orally)~Medication: Topiramate (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
1074708|NCT00626925|O2|Outcome|Placebo|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
1074709|NCT00626925|O1|Outcome|Active Med|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
1074710|NCT00626925|O2|Outcome|Placebo|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
1074711|NCT00626925|O1|Outcome|Active Med|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
1074712|NCT00626925|O6|Outcome|Placebo AA Genotype|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
1074713|NCT00626925|O5|Outcome|Topiramate AA Genotype|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
1074714|NCT00626925|O4|Outcome|Placebo AC Genotype|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
1074715|NCT00626925|O3|Outcome|Topiramate AC Genotype|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
1074716|NCT00626925|O2|Outcome|Placebo CC Genotype|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
1074717|NCT00626925|O1|Outcome|Topiramate CC Genotype|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
1074718|NCT00626925|O6|Outcome|Placebo AA Genotype|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
1074719|NCT00626925|O5|Outcome|Topiramate AA Genotype|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
1074720|NCT00626925|O4|Outcome|Placebo AC Genotype|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
1074721|NCT00626925|O3|Outcome|Topiramate AC Genotype|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
1074722|NCT00626925|O2|Outcome|Placebo CC Genotype|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
1074723|NCT00626925|O1|Outcome|Topiramate CC Genotype|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
1074724|NCT00626925|O2|Outcome|Placebo Group|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
1074725|NCT00626925|O1|Outcome|Active Med|"Topiramate (up to 200 mg orally)~Medication: Topiramate (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
1074726|NCT00626925|O2|Outcome|Placebo Group|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
1074727|NCT00626925|O1|Outcome|Active Med|"Topiramate (up to 200 mg orally)~Medication: Topiramate (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
1074728|NCT00626925|E2|Reported Event|Placebo Group|"placebo~placebo: placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
1074729|NCT00626925|E1|Reported Event|Topiramate Group|"topiramate (up to 200 mg orally)~topiramate: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)"
1074730|NCT00626821|B1|Baseline|SenSura|Test of SenSura for 6-8 weeks
1074731|NCT00626821|P1|Participant Flow|SenSura|Test of SenSura for 6-8 weeks
1074732|NCT00626821|O1|Outcome|SenSura|Participants tested SenSura for 6-8 weeks. Baseline data were informations about pre-study product.
1074733|NCT00626821|E1|Reported Event|SenSura|Test of SenSura for 6-8 weeks
1074734|NCT00626808|B5|Baseline|Total|Total of all reporting groups
1074735|NCT00626808|B4|Baseline|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
1074736|NCT00626808|B3|Baseline|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
1074737|NCT00626808|B2|Baseline|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
1074738|NCT00626808|B1|Baseline|Participants Less Than 24 Months of Age|Participants less than 24 months of age
1074849|NCT00626574|P2|Participant Flow|Saline|Group B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3).
1075748|NCT00624065|O1|Outcome|Lisinopril|Lisinopril monotherapy (10, 20, or 40 mg once daily)
1074739|NCT00626808|P4|Participant Flow|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
1074740|NCT00626808|P3|Participant Flow|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
1074741|NCT00626808|P2|Participant Flow|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
1074742|NCT00626808|P1|Participant Flow|Participants Less Than 24 Months of Age|Participants less than 24 months of age
1074743|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
1074744|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
1074745|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
1074746|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
1074747|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
1074748|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
1074749|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
1074750|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
1074751|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
1074752|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
1074753|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
1074754|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
1074755|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
1074756|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
1074757|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
1074758|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
1074759|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
1074760|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
1074761|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
1074762|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
1074763|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
1074764|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
1074765|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
1074766|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
1074767|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
1074768|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
1074769|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
1074770|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
1074771|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
1074772|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
1074773|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
1074774|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
1074775|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
1074776|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
1074777|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
1074778|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
1074779|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
1074780|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
1074781|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
1074782|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
1074783|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
1074784|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
1074785|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
1074786|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
1074787|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
1074788|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
1074789|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
1074790|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
1074791|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
1074792|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
1074793|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
1074794|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
1074795|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
1074796|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
1074797|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
1074798|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
1074799|NCT00626808|O4|Outcome|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
1074800|NCT00626808|O3|Outcome|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
1074801|NCT00626808|O2|Outcome|Participants 24-59 Months of Age With Asthma|Participants 24-59 months of age with a claim associated with a diagnosis of asthma
1074802|NCT00626808|O1|Outcome|Participants Less Than 24 Months of Age|Participants less than 24 months of age
1074803|NCT00626808|E4|Reported Event|Participants 24-59 Months of Age With Immunosuppression|Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
1074804|NCT00626808|E3|Reported Event|Participants 24-59 Months of Age With Wheezing|Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
1074805|NCT00626808|E2|Reported Event|Children 24-59 Months With Asthma|
1074806|NCT00626808|E1|Reported Event|Participants Less Than 24 Months of Age|Participants less than 24 months of age
1074807|NCT00626782|B3|Baseline|Total|Total of all reporting groups
1074808|NCT00626782|B2|Baseline|Treatment 2 (Mitomycin C 0.4 mg/ml)|"Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery.~Mytomycin C 0.4 mg/ml: Mitomycin C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery."
1074809|NCT00626782|B1|Baseline|Treatment 1 (Ranibizumab 0.5mg)|"Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery.~Ranibizumab: Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery"
1074810|NCT00626782|P2|Participant Flow|Treatment 2 (Mitomycin C 0.4 mg/ml)|"Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery.~Mytomycin C 0.4 mg/ml: Mitomycin C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery."
1074811|NCT00626782|P1|Participant Flow|Treatment 1 (Ranibizumab 0.5mg)|"Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery.~Ranibizumab: Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery"
1074812|NCT00626782|O2|Outcome|Treatment 2 (Mitomycin C 0.4 mg/ml)|"Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery.~Mytomycin C 0.4 mg/ml: Mitomycin C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery."
1074813|NCT00626782|O1|Outcome|Treatment 1 (Ranibizumab 0.5mg)|"Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery.~Ranibizumab: Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery"
1074814|NCT00626782|E2|Reported Event|Treatment 2 (Mitomycin C 0.4 mg/ml)|"Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery.~Mytomycin C 0.4 mg/ml: Mitomycin C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery."
1074815|NCT00626782|E1|Reported Event|Treatment 1 (Ranibizumab 0.5mg)|"Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery.~Ranibizumab: Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery"
1074816|NCT00626743|B3|Baseline|Total|Total of all reporting groups
1074817|NCT00626743|B2|Baseline|Asan Medical Center|
1074818|NCT00626743|B1|Baseline|INJE University Pusan Paik Hospital|
1074819|NCT00626743|P2|Participant Flow|Placebo|"Tablet which has the same appearance and taste but doesn’t contain active ingredient~SK3530 100mg, Placebo, Amlodipine"
1074820|NCT00626743|P1|Participant Flow|SK3530|"Active Drug~SK3530 100mg, Placebo, Amlodipine"
1074821|NCT00626743|O2|Outcome|Amlodipine + Placebo|
1074822|NCT00626743|O1|Outcome|Amlodipine + SK3530|
1074823|NCT00626743|O2|Outcome|Amlodipine + Placebo|
1074824|NCT00626743|O1|Outcome|Amlodipine + SK3530|
1074825|NCT00626743|E2|Reported Event|Amlodipine + Placebo|
1074826|NCT00626743|E1|Reported Event|Amlodipine + SK3530|
1074827|NCT00626639|B3|Baseline|Total|Total of all reporting groups
1074828|NCT00626639|B2|Baseline|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
1074829|NCT00626639|B1|Baseline|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
1074830|NCT00626639|P2|Participant Flow|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
1074831|NCT00626639|P1|Participant Flow|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
1074832|NCT00626639|O2|Outcome|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
1074850|NCT00626574|P1|Participant Flow|Procrit|Group A will receive Procrit® intravenous injections (40,000U) once daily for 3 days (Study Days 1, 2, and 3). The first dose of Procrit® will be given within 36 hours of the initial SAH event / symptoms and immediately before the vascular clipping procedure.
1074851|NCT00626574|O2|Outcome|Saline|Group B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3).
1074833|NCT00626639|O1|Outcome|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
1074834|NCT00626639|O2|Outcome|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
1074835|NCT00626639|O1|Outcome|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
1074836|NCT00626639|O2|Outcome|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
1074837|NCT00626639|O1|Outcome|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
1074838|NCT00626639|O2|Outcome|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
1074839|NCT00626639|O1|Outcome|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
1074840|NCT00626639|O2|Outcome|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
1074841|NCT00626639|O1|Outcome|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
1074842|NCT00626639|O2|Outcome|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
1074843|NCT00626639|O1|Outcome|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
1074844|NCT00626639|E2|Reported Event|Palifermin|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
1074845|NCT00626639|E1|Reported Event|Placebo|Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
1074846|NCT00626574|B3|Baseline|Total|Total of all reporting groups
1074847|NCT00626574|B2|Baseline|Saline|Group B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3).
1074848|NCT00626574|B1|Baseline|Procrit|Group A will receive Procrit® intravenous injections (40,000U) once daily for 3 days (Study Days 1, 2, and 3). The first dose of Procrit® will be given within 36 hours of the initial SAH event / symptoms and immediately before the vascular clipping procedure.
1075889|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
1074852|NCT00626574|O1|Outcome|Procrit|Group A will receive Procrit® intravenous injections (40,000U) once daily for 3 days (Study Days 1, 2, and 3). The first dose of Procrit® will be given within 36 hours of the initial SAH event / symptoms and immediately before the vascular clipping procedure.
1074853|NCT00626574|E2|Reported Event|Saline|Group B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3).
1074854|NCT00626574|E1|Reported Event|Procrit|Group A will receive Procrit® intravenous injections (40,000U) once daily for 3 days (Study Days 1, 2, and 3). The first dose of Procrit® will be given within 36 hours of the initial SAH event / symptoms and immediately before the vascular clipping procedure.
1074855|NCT00626561|B1|Baseline|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m^2 IV weekly.
1074856|NCT00626561|P1|Participant Flow|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m^2 IV weekly.
1074857|NCT00626561|O1|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m^2 IV weekly.
1074858|NCT00626561|E1|Reported Event|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m^2 IV weekly.
1074859|NCT00626548|B3|Baseline|Total|Total of all reporting groups
1074860|NCT00626548|B2|Baseline|Placebo|Placebo oral tablet once daily
1074861|NCT00626548|B1|Baseline|ZD4054|ZD4054 10 mg oral tablet once daily
1074862|NCT00626548|P2|Participant Flow|Placebo|Placebo oral tablet once daily
1074863|NCT00626548|P1|Participant Flow|ZD4054|ZD4054 10 mg oral tablet once daily
1074864|NCT00626548|O2|Outcome|Placebo|Placebo oral tablet once daily
1074865|NCT00626548|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
1074866|NCT00626548|O2|Outcome|Placebo|Placebo oral tablet once daily
1074867|NCT00626548|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
1074868|NCT00626548|E2|Reported Event|Placebo|Placebo oral tablet once daily
1074869|NCT00626548|E1|Reported Event|ZD4054|ZD4054 10 mg oral tablet once daily
1074870|NCT00626522|B7|Baseline|Total|Total of all reporting groups
1074871|NCT00626522|B6|Baseline|Placebo|Placebo once-daily
1074872|NCT00626522|B5|Baseline|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
1074873|NCT00626522|B4|Baseline|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
1074874|NCT00626522|B3|Baseline|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
1074875|NCT00626522|B2|Baseline|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
1074876|NCT00626522|B1|Baseline|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
1074877|NCT00626522|P6|Participant Flow|Placebo|Placebo once-daily
1074878|NCT00626522|P5|Participant Flow|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
1074879|NCT00626522|P4|Participant Flow|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
1074880|NCT00626522|P3|Participant Flow|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
1074881|NCT00626522|P2|Participant Flow|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
1074882|NCT00626522|P1|Participant Flow|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
1074883|NCT00626522|O6|Outcome|Placebo|Placebo once-daily
1074884|NCT00626522|O5|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
1074885|NCT00626522|O4|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
1074886|NCT00626522|O3|Outcome|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
1074887|NCT00626522|O2|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
1074888|NCT00626522|O1|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
1074889|NCT00626522|O6|Outcome|Placebo|Placebo once-daily
1074890|NCT00626522|O5|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
1074891|NCT00626522|O4|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
1074892|NCT00626522|O3|Outcome|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
1074893|NCT00626522|O2|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
1074894|NCT00626522|O1|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
1074895|NCT00626522|O6|Outcome|Placebo|Placebo once-daily
1074896|NCT00626522|O5|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
1074897|NCT00626522|O4|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
1074898|NCT00626522|O3|Outcome|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
1074899|NCT00626522|O2|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
1074900|NCT00626522|O1|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
1074901|NCT00626522|O6|Outcome|Placebo|Placebo once-daily
1074902|NCT00626522|O5|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
1074903|NCT00626522|O4|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
1074904|NCT00626522|O3|Outcome|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
1074905|NCT00626522|O2|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
1075890|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
1074906|NCT00626522|O1|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
1074907|NCT00626522|O6|Outcome|Placebo|Placebo once-daily
1074908|NCT00626522|O5|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
1074909|NCT00626522|O4|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
1074910|NCT00626522|O3|Outcome|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
1074911|NCT00626522|O2|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
1074912|NCT00626522|O1|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
1074913|NCT00626522|E6|Reported Event|Placebo|Placebo once-daily
1074914|NCT00626522|E5|Reported Event|Formoterol 12 μg|Formoterol fumarate 12 μg once-daily
1074915|NCT00626522|E4|Reported Event|Aclidinium 200 μg|Aclidinium bromide 200 μg once-daily
1074916|NCT00626522|E3|Reported Event|Aclidinium 200 μg / Formoterol 18 μg|Aclidinium bromide 200 μg + formoterol fumarate 18 μg fixed dose combination (FDC) once-daily
1074917|NCT00626522|E2|Reported Event|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) once-daily
1074918|NCT00626522|E1|Reported Event|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) once-daily
1074919|NCT00626444|B1|Baseline|Vitamin C|"Intravenous vitamin C~Intravenous vitamin C: Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks."
1074920|NCT00626444|P1|Participant Flow|Vitamin C|"Intravenous vitamin C~Intravenous vitamin C: Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks."
1074921|NCT00626444|O1|Outcome|Vitamin C|"Intravenous vitamin C~Intravenous vitamin C: Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks."
1074922|NCT00626444|O1|Outcome|Vitamin C|"Intravenous vitamin C~Intravenous vitamin C: Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks."
1074923|NCT00626444|E1|Reported Event|Vitamin C|"Intravenous vitamin C~Intravenous vitamin C: Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks."
1074924|NCT00626431|B3|Baseline|Total|Total of all reporting groups
1074925|NCT00626431|B2|Baseline|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
1074926|NCT00626431|B1|Baseline|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular (IM) injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
1074927|NCT00626431|P2|Participant Flow|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
1074928|NCT00626431|P1|Participant Flow|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular (IM) injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
1074929|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
1074930|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
1074931|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
1074932|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
1074933|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
1074934|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
1074935|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
1074936|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
1075024|NCT00626275|O1|Outcome|Placebo (Part A)|Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
1074937|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
1074938|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
1074939|NCT00626431|O1|Outcome|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
1074940|NCT00626431|E2|Reported Event|Leuprolide Acetate - Formulation B|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular injections of Formulation B, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
1074941|NCT00626431|E1|Reported Event|Leuprolide Acetate - Formulation A|Leuprolide acetate 45 mg, 6-month depot administered as 2 intramuscular (IM) injections of Formulation A, 24 weeks apart. Injections were administered on Day 1 and Day 169. The first 150 subjects were to receive Formulation A and then the next 150 subjects were to receive Formulation B in a sequential manner.
1074942|NCT00626392|B7|Baseline|Total|Total of all reporting groups
1074943|NCT00626392|B6|Baseline|NER 1000; ASA Pbo run-in, ASA Pbo Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
1074944|NCT00626392|B5|Baseline|NER 1000; ASA Pbo run-in, ASA Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
1074945|NCT00626392|B4|Baseline|NER 1000; ASA run-in, ASA Coadmin|Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
1074946|NCT00626392|B3|Baseline|NER 500; ASA Pbo run-in, ASA Pbo Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
1074947|NCT00626392|B2|Baseline|NER 500; ASA Pbo run-in, ASA Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
1074948|NCT00626392|B1|Baseline|NER 500; ASA run-in, ASA Coadmin|Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
1074949|NCT00626392|P6|Participant Flow|NER 1000; ASA Pbo run-in, ASA Pbo Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
1074950|NCT00626392|P5|Participant Flow|NER 1000; ASA Pbo run-in, ASA Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
1074951|NCT00626392|P4|Participant Flow|NER 1000; ASA run-in; ASA Coadmin|Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 1000 mg starting dose), daily during coadministration (4 weeks)
1074952|NCT00626392|P3|Participant Flow|NER 500; ASA Pbo run-in, ASA Pbo Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
1074953|NCT00626392|P2|Participant Flow|NER 500; ASA Pbo run-in, ASA Coadmin|Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
1074954|NCT00626392|P1|Participant Flow|NER 500; ASA run-in, ASA Coadmin|Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release ([NER], 500 mg starting dose), daily during coadministration (4 weeks)
1074955|NCT00626392|O2|Outcome|No Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.
1074956|NCT00626392|O1|Outcome|Any Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.
1074957|NCT00626392|O2|Outcome|No Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.
1074958|NCT00626392|O1|Outcome|Any Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.
1074959|NCT00626392|O2|Outcome|No Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.
1074960|NCT00626392|O1|Outcome|Any Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.
1074961|NCT00626392|O2|Outcome|No Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.
1074962|NCT00626392|O1|Outcome|Any Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.
1074963|NCT00626392|E2|Reported Event|No Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.
1074964|NCT00626392|E1|Reported Event|Any Acetylsalicylic Acid|Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.
1074965|NCT00626340|B1|Baseline|All Participants|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
1075531|NCT00624559|B3|Baseline|Placebo, Low Sodium|Placebo pill taken twice per day over the course of the diet
1074966|NCT00626340|P1|Participant Flow|All Participants|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
1074967|NCT00626340|O1|Outcome|All Participants|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
1074968|NCT00626340|E1|Reported Event|All Participants|This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
1074969|NCT00626327|B4|Baseline|Total|Total of all reporting groups
1074970|NCT00626327|B3|Baseline|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
1074971|NCT00626327|B2|Baseline|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
1074972|NCT00626327|B1|Baseline|MenACWY-CRM+ MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
1074973|NCT00626327|P3|Participant Flow|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
1074974|NCT00626327|P2|Participant Flow|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
1074975|NCT00626327|P1|Participant Flow|MenACWY-CRM+ MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
1074976|NCT00626327|O3|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
1074977|NCT00626327|O2|Outcome|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
1074978|NCT00626327|O1|Outcome|MenACWY-CRM+ MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
1074979|NCT00626327|O3|Outcome|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
1074980|NCT00626327|O2|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
1074981|NCT00626327|O1|Outcome|MenACWY-CRM+MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
1074982|NCT00626327|O1|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months.
1074983|NCT00626327|O1|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months.
1074984|NCT00626327|O2|Outcome|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
1074985|NCT00626327|O1|Outcome|MenACWY-CRM +MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
1074986|NCT00626327|O2|Outcome|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
1074987|NCT00626327|O1|Outcome|MenACWY-CRM+ MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
1074988|NCT00626327|O2|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months.
1074989|NCT00626327|O1|Outcome|MenACWY-CRM + MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
1074990|NCT00626327|O2|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months.
1074991|NCT00626327|O1|Outcome|MenACWY-CRM+MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
1074992|NCT00626327|O1|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
1074993|NCT00626327|O2|Outcome|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
1074994|NCT00626327|O1|Outcome|MenACWY-CRM+ MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
1074995|NCT00626327|O2|Outcome|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
1074996|NCT00626327|O1|Outcome|MenACWY-CRM+ MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
1074997|NCT00626327|E3|Reported Event|MenACWY-CRM|Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
1074998|NCT00626327|E2|Reported Event|MMRV|Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
1074999|NCT00626327|E1|Reported Event|MenACWY-CRM+ MMRV|Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
1075532|NCT00624559|B2|Baseline|Celebrex, Low Sodium|100 mg Celebrex, twice per day for 7 days on low sodium diet
1075000|NCT00626275|B1|Baseline|All Treated Participants|All participants who received at least 1 dose of study drug during any sequence of Part A of the study. Baseline measures reported in aggregate for all participants to avoid double counting of Parts A and B.
1075001|NCT00626275|P8|Participant Flow|Part B: Placebo|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
1075002|NCT00626275|P7|Participant Flow|Part B: ADL5859 100 mg|ADL5859: 100 mg, capsules, administered orally, twice daily (BID) for 2 weeks during Part B of the study
1075003|NCT00626275|P6|Participant Flow|Part A Sequence 6: ADL5859 First, Then Placebo, Then Naproxen|"Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours. During each treatment period of Part A, participants received a single dose of study medication (ADL5859 200 mg, then placebo, then naproxen 500 mg).~Part A, Treatment Period 1: ADL5859 200 mg, capsules, administered orally as a single dose; Part A, Treatment Period 2: matching placebo, capsules, administered orally, as a single dose; and Part A, Treatment Period 3: naproxen 500 mg, capsules, administered orally as a single dose."
1075004|NCT00626275|P5|Participant Flow|Part A Sequence 5: Placebo First, Then Naproxen, Then ADL5859|"Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours and up to 1 week between doses. During each treatment period of Part A, participants received a single dose of study medication (placebo, then naproxen 500 mg, then ADL5859 200 mg).~Part A, Treatment Period 1: matching placebo, capsules, administered orally, as a single dose; Part A, Treatment Period 2: naproxen 500 mg, capsules, administered orally as a single dose; and Part A, Treatment Period 3: ADL5859 200 mg, capsules, administered orally as a single dose."
1075005|NCT00626275|P4|Participant Flow|Part A Sequence 4: Naproxen First, Then ADL5859, Then Placebo|"Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours and up to 1 week between doses. During each treatment period of Part A, participants received a single dose of study medication (naproxen 500 mg, then ADL5859 200 mg, then placebo).~Part A, Treatment Period 1: naproxen 500 mg, capsules, administered orally as a single dose; Part A, Treatment Period 2: ADL5859 200 mg, capsules, administered orally as a single dose; and Part A, Treatment Period 3: matching placebo, capsules, administered orally, as a single dose."
1075006|NCT00626275|P3|Participant Flow|Part A Sequence 3: Naproxen First, Then Placebo, Then ADL5859|"Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours and up to 1 week between doses. During each treatment period of Part A, participants received a single dose of study medication (naproxen 500 mg, then placebo, then ADL5859 200 mg).~Part A, Treatment Period 1: naproxen 500 mg, capsules, administered orally as a single dose; Part A, Treatment Period 2: matching placebo, capsules, administered orally, as a single dose; and Part A, Treatment Period 3: ADL5859 200 mg, capsules, administered orally as a single dose."
1075007|NCT00626275|P2|Participant Flow|Part A Sequence 2: ADL5859 First, Then Naproxen, Then Placebo|"Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours and up to 1 week between doses. During each treatment period of Part A, participants received a single dose of study medication (ADL5859 200 mg, then naproxen 500 mg, then placebo).~Part A, Treatment Period 1: ADL5859 200 mg, capsules, administered orally as a single dose; Part A, Treatment Period 2: naproxen 500 mg, capsules, administered orally as a single dose; and Part A, Treatment Period 3: matching placebo, capsules, administered orally, as a single dose."
1075008|NCT00626275|P1|Participant Flow|Part A, Sequence 1: Placebo First, Then ADL5859, Then Naproxen|"Eligible participants were randomized to 1 of 6 treatment sequences. Each treatment sequence had 3 treatment periods, each separated by a washout period of at least 48 hours and up to 1 week between doses. During each treatment period of Part A, participants received a single dose of study medication (placebo, then ADL5859 200 milligrams (mg), then naproxen 500 mg).~Part A, Treatment Period 1: matching placebo, capsules, administered orally, as a single dose; Part A, Treatment Period 2: ADL5859 200 mg, capsules, administered orally as a single dose; and Part A, Treatment Period 3: naproxen 500 mg, capsules, administered orally as a single dose"
1075009|NCT00626275|O2|Outcome|ADL5859 - 100 mg (Part B)|ADL5859: 100 mg, capsules, administered orally, BID for 2 weeks during Part B of the study
1075010|NCT00626275|O1|Outcome|Placebo (Part B)|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
1075011|NCT00626275|O3|Outcome|ADL5859 - 200 mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
1075012|NCT00626275|O2|Outcome|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
1075013|NCT00626275|O1|Outcome|Placebo (Part A)|Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
1075014|NCT00626275|O2|Outcome|ADL5859 - 100 mg (Part B)|ADL5859: 100 mg, capsules, administered orally, BID for 2 weeks during Part B of the study
1075015|NCT00626275|O1|Outcome|Placebo (Part B)|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
1075016|NCT00626275|O2|Outcome|ADL5859 - 100 mg (Part B)|ADL5859: 100 mg, capsules, administered orally, BID for 2 weeks during Part B of the study
1075017|NCT00626275|O1|Outcome|Placebo (Part B)|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
1075018|NCT00626275|O2|Outcome|ADL5859 - 100 mg (Part B)|ADL5859: 100 mg, capsules, administered orally, BID for 2 weeks during Part B of the study
1075019|NCT00626275|O1|Outcome|Placebo (Part B)|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
1075020|NCT00626275|O2|Outcome|ADL5859 - 100 mg (Part B)|ADL5859: 100 mg, capsules, administered orally, BID for 2 weeks during Part B of the study
1075021|NCT00626275|O1|Outcome|Placebo (Part B)|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
1075022|NCT00626275|O3|Outcome|ADL5859 - 200 mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
1075023|NCT00626275|O2|Outcome|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
1075891|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
1075892|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
1075025|NCT00626275|O3|Outcome|ADL5859 - 200 mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
1075026|NCT00626275|O2|Outcome|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
1075027|NCT00626275|O1|Outcome|Placebo (Part A)|Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
1075028|NCT00626275|O3|Outcome|ADL5859 - 200 mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
1075029|NCT00626275|O2|Outcome|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
1075030|NCT00626275|O1|Outcome|Placebo (Part A)|Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
1075031|NCT00626275|O3|Outcome|ADL5859 - 200mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
1075032|NCT00626275|O2|Outcome|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
1075033|NCT00626275|O1|Outcome|Placebo (Part A)|Matching placebo capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
1075034|NCT00626275|O2|Outcome|ADL5859 - 100 mg (Part B)|ADL5859: 100 mg, capsules, administered orally, BID for 2 weeks during Part B of the study
1075035|NCT00626275|O1|Outcome|Placebo (Part B)|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
1075036|NCT00626275|O3|Outcome|ADL5859 - 200 mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
1075037|NCT00626275|O2|Outcome|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
1075038|NCT00626275|O1|Outcome|Placebo (Part A)|Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
1075039|NCT00626275|O3|Outcome|ADL5859 - 200 mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
1075040|NCT00626275|O2|Outcome|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
1075041|NCT00626275|O1|Outcome|Placebo (Part A)|Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
1075042|NCT00626275|E5|Reported Event|ADL5859 - 100 mg (Part B)|ADL5859: 100 mg, capsules, administered orally, BID for 2 weeks during Part B of the study
1075043|NCT00626275|E4|Reported Event|Placebo (Part B)|Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study
1075044|NCT00626275|E3|Reported Event|ADL5859 - 200 mg (Part A)|ADL5859: 200 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
1075045|NCT00626275|E2|Reported Event|Naproxen - 500 mg (Part A)|Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study
1075046|NCT00626275|E1|Reported Event|Placebo (Part A)|Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study
1075047|NCT00626210|B1|Baseline|Modafinil|Open label study in which all participants get modafinil
1075048|NCT00626210|P1|Participant Flow|Modafinil|daily 100 mg of modafinil within 1 hr of awakening for one week followed by daily 200 mg of modafinil within 1 hr of awakening for one week
1075049|NCT00626210|O1|Outcome|Modafinil|
1075050|NCT00626210|E1|Reported Event|Modafinil|
1075051|NCT00626093|B1|Baseline|Group 1|
1075052|NCT00626093|P1|Participant Flow|Cardiac Resynchronization Therapy - Defibrillators (CRT-D)|All patients enrolled were indicated for a CRT-D.
1075053|NCT00626093|O1|Outcome|CRT-D|
1075054|NCT00626093|O1|Outcome|CRT-D|
1075055|NCT00626093|E1|Reported Event|Group 1|
1075056|NCT00626028|B3|Baseline|Total|Total of all reporting groups
1075057|NCT00626028|B2|Baseline|Oxygen First, Nitric Oxide Last|10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm
1075058|NCT00626028|B1|Baseline|Nitric Oxide First, Oxygen Last|10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen
1075059|NCT00626028|P2|Participant Flow|Oxygen First, Nitric Oxide Last|10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm
1075060|NCT00626028|P1|Participant Flow|Nitric Oxide First, Oxygen Last|10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen
1075061|NCT00626028|O2|Outcome|Oxygen First, Nitric Oxide Last|10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm
1075062|NCT00626028|O1|Outcome|Nitric Oxide First, Oxygen Last|10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen
1075063|NCT00626028|O2|Outcome|Oxygen First, Nitric Oxide Last|10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm
1075064|NCT00626028|O1|Outcome|Nitric Oxide First, Oxygen Last|10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen
1075065|NCT00626028|O2|Outcome|Oxygen First, Nitric Oxide Last|10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm
1075066|NCT00626028|O1|Outcome|Nitric Oxide First, Oxygen Last|10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen
1075067|NCT00626028|E2|Reported Event|Oxygen First, Nitric Oxide Last|10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm
1075749|NCT00624065|E2|Reported Event|Carvedilol CR + Lisinopril|Carvedilol controlled release (CR) + lisinopril (20 + 10, 20 + 20, or 40 + 20 mg once daily)
1075068|NCT00626028|E1|Reported Event|Nitric Oxide First, Oxygen Last|10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen
1075069|NCT00625989|B1|Baseline|Mild Asthmatics|Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.
1075070|NCT00625989|P2|Participant Flow|Allergen Then Diluent Challenge|"Subjects were screened, then given a 2 week washout period.~Samples collected on day 1 according to protocol. Day 2 allergen challenge was preformed and samples collected according to the protocol. Subjects returned on day 3 for 24 hour follow up and samples collected according to the protocol.~Two week wash out period.~Samples collected on day 1, after washout, according to protocol. Day 2, after washout, dilluent challenge was preformed and samples collected according to the protocol. Subjects returned on day 3, after wash out, for 24 hour follow up and samples collected according to the protocol."
1075071|NCT00625989|P1|Participant Flow|Diluent Then Allergen Challenge|"Subjects were screened, then given a 2 week washout period.~Samples collected on day 1 according to protocol. Day 2 diluent challenge was preformed and samples collected according to the protocol. Subjects returned on day 3 for 24 hour follow up and samples collected according to the protocol.~Two week wash out period.~Samples collected on day 1, after washout, according to protocol. Day 2, after washout, allergen challenge was preformed and samples collected according to the protocol. Subjects returned on day 3, after wash out, for 24 hour follow up and samples collected according to the protocol."
1075072|NCT00625989|O2|Outcome|Allergen|Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.
1075073|NCT00625989|O1|Outcome|Diluent|Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.
1075074|NCT00625989|O2|Outcome|Allergen|Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.
1075075|NCT00625989|O1|Outcome|Diluent|Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.
1075076|NCT00625989|E1|Reported Event|Mild Asthmatics|Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.
1075077|NCT00625872|B3|Baseline|Total|Total of all reporting groups
1075078|NCT00625872|B2|Baseline|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075079|NCT00625872|B1|Baseline|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075080|NCT00625872|P2|Participant Flow|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075081|NCT00625872|P1|Participant Flow|Somatropin|Somatropin 0.035 milligram/kilogram/day (mg/kg/day) was administered subcutaneously (s.c) according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075082|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075083|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075084|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075085|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075086|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075087|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075088|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075089|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075090|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075091|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075092|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075093|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075094|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075095|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075096|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075097|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075098|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075750|NCT00624065|E1|Reported Event|Lisinopril|Lisinopril monotherapy (10, 20, or 40 mg once daily)
1075099|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075100|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075101|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075102|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075103|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075104|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075105|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075106|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075107|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075108|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075109|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075110|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075111|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075112|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075113|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075114|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075115|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075116|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075117|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075118|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075119|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075120|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075121|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075122|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075123|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075124|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075125|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075126|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075127|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075128|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075129|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075130|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075131|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075751|NCT00624052|B5|Baseline|Total|Total of all reporting groups
1075132|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075133|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075134|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075135|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075136|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075137|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075138|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075139|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075140|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075141|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075142|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075143|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075144|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075145|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075146|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075147|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075148|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075149|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075150|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075151|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075152|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075153|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075154|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075155|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075156|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075157|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075158|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075159|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075160|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075161|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075162|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075163|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075164|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075893|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
1075165|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075166|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075167|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075168|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075169|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075170|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075171|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075172|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075173|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075174|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075175|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075176|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075177|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075178|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075179|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075180|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075181|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075182|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075183|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075184|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075185|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075186|NCT00625872|O2|Outcome|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075187|NCT00625872|O1|Outcome|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075188|NCT00625872|E2|Reported Event|Control Arm|No treatment for initial 6 months in control group, after 6 months, somatropin 0.067 mg/kg/day administered s.c. according to exact body weight specific calculation for 12 months.
1075189|NCT00625872|E1|Reported Event|Somatropin|Somatropin 0.035 mg/kg/day was administered s.c according to exact body weight specific calculation for 12 months. Dose adjustments were made at 6 month intervals.
1075190|NCT00625820|B1|Baseline|1BH4, BH4 + Vitamin C|"Tetrahydrobiopterin (6R BH4) : 400 mg 6R BH4 oral BID for 6 weeks then 400 mg of 6R BH4 for another 6 weeks~Vitamin C : 500 mg Vitamin C oral BID for another 6 weeks"
1075191|NCT00625820|P1|Participant Flow|1BH4, BH4 + Vitamin C|"Tetrahydrobiopterin (6R BH4) : 400 mg 6R BH4 oral BID for 6 weeks then 400 mg of 6R BH4 for another 6 weeks~Vitamin C : 500 mg Vitamin C oral BID for another 6 weeks"
1075192|NCT00625820|O1|Outcome|1BH4, BH4 + Vitamin C|"Tetrahydrobiopterin (6R BH4) : 400 mg 6R BH4 oral BID for 6 weeks then 400 mg of 6R BH4 for another 6 weeks~Vitamin C : 500 mg Vitamin C oral BID for another 6 weeks"
1075193|NCT00625820|O1|Outcome|1BH4, BH4 + Vitamin C|"Tetrahydrobiopterin (6R BH4) : 400 mg 6R BH4 oral BID for 6 weeks then 400 mg of 6R BH4 for another 6 weeks~Vitamin C : 500 mg Vitamin C oral BID for another 6 weeks"
1075194|NCT00625820|O1|Outcome|1BH4, BH4 + Vitamin C|
1075195|NCT00625820|E1|Reported Event|BH4, BH4 + Vit C|
1075196|NCT00625742|B1|Baseline|Multimodal Treatment Strategy|Exercise Program + Pharmacologic Intervention (Atenolol + Ibuprofen + Melatonin) + Nutritional Supplementation (Juven) - Resistance training sessions twice weekly using Thera-bands. Walking or running for 3-4 minutes, and Oral Melatonin 20 mg Daily. 90 calories of Juven, twice a day.
1075197|NCT00625742|P1|Participant Flow|Multimodal Treatment Strategy|Exercise Program + Pharmacologic Intervention (Atenolol + Ibuprofen + Melatonin) + Nutritional Supplementation (Juven) - Resistance training sessions twice weekly using Thera-bands. Walking or running for 3-4 minutes, and Oral Melatonin 20 mg Daily. 90 calories of Juven, twice a day.
1075894|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
1075198|NCT00625742|O1|Outcome|Multimodal Treatment Strategy|Exercise Program + Pharmacologic Intervention (Atenolol + Ibuprofen + Melatonin) + Nutritional Supplementation (Juven) - Resistance training sessions twice weekly using Thera-bands. Walking or running for 3-4 minutes, and Oral Melatonin 20 mg Daily. 90 calories of Juven, twice a day.
1075199|NCT00625742|O1|Outcome|Multimodal Treatment Strategy|Exercise Program + Pharmacologic Intervention (Atenolol + Ibuprofen + Melatonin) + Nutritional Supplementation (Juven) - Resistance training sessions twice weekly using Thera-bands. Walking or running for 3-4 minutes, and Oral Melatonin 20 mg Daily. 90 calories of Juven, twice a day.
1075200|NCT00625742|E1|Reported Event|Multimodal Treatment Strategy|Exercise Program + Pharmacologic Intervention (Atenolol + Ibuprofen + Melatonin) + Nutritional Supplementation (Juven) - Resistance training sessions twice weekly using Thera-bands. Walking or running for 3-4 minutes, and Oral Melatonin 20 mg Daily. 90 calories of Juven, twice a day.
1075201|NCT00625729|B1|Baseline|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
1075202|NCT00625729|P1|Participant Flow|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
1075203|NCT00625729|O1|Outcome|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
1075204|NCT00625729|O1|Outcome|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
1075205|NCT00625729|O1|Outcome|Responder Patients|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with donor natural killer cells infusion, rituximab, aldesleukin and chemotherapy who had a response to treatment (clinical response or partial response).
1075206|NCT00625729|O1|Outcome|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
1075207|NCT00625729|O1|Outcome|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
1075208|NCT00625729|O1|Outcome|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
1075209|NCT00625729|E1|Reported Event|Patients Treated With Natural Killer Cells|Patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with 1 dose donor natural killer cells infusion, 4 doses rituximab, 6 doses aldesleukin and 5 doses fludarabine and 1 dose cyclosphosphamide.
1075210|NCT00625586|B1|Baseline|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
1075211|NCT00625586|P1|Participant Flow|RAV12 Plus Gemcitabine|RAV12 monoclonal antibody plus gemcitabine
1075212|NCT00625586|O1|Outcome|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
1075213|NCT00625586|O1|Outcome|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
1075214|NCT00625586|O1|Outcome|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
1075215|NCT00625586|O1|Outcome|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
1075216|NCT00625586|O1|Outcome|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
1075217|NCT00625586|O1|Outcome|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
1075218|NCT00625586|O1|Outcome|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
1075219|NCT00625586|E1|Reported Event|RAV12 Plus Gemcitabine|Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
1075220|NCT00625404|B3|Baseline|Total|Total of all reporting groups
1075221|NCT00625404|B2|Baseline|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
1075222|NCT00625404|B1|Baseline|Truvada Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
1075223|NCT00625404|P2|Participant Flow|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
1075224|NCT00625404|P1|Participant Flow|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
1075752|NCT00624052|B4|Baseline|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
1075225|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
1075226|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
1075227|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
1075228|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
1075229|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
1075230|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
1075231|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
1075232|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
1075233|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
1075234|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
1075235|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
1075236|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
1075237|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
1075238|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
1075239|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
1075240|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
1075241|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
1075242|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
1075243|NCT00625404|O2|Outcome|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
1075244|NCT00625404|O1|Outcome|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
1075245|NCT00625404|O2|Outcome|Placebo Arm|The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.
1075246|NCT00625404|O1|Outcome|Truvada Arm|The effectiveness population consisted of all women who were randomized and who had at least one follow-up visit and were not HIV PCR positive at enrollment. This population consisted of 2056 women (1024 in the Truvada arm, 1032 in the placebo arm) and was used for baseline analyses.
1075247|NCT00625404|E2|Reported Event|Placebo Arm|Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
1075248|NCT00625404|E1|Reported Event|Truvada Arm|Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
1075249|NCT00625391|B5|Baseline|Total|Total of all reporting groups
1075250|NCT00625391|B4|Baseline|GTP+Tai Chi|GTP+Tai Chi group receiving both GTP and Tai Chi training for 24 weeks.
1075251|NCT00625391|B3|Baseline|Placebo+Tai Chi|Placebo+Tai Chi group receiving both placebo treatment and Tai Chi training (60-minute group exercise, 3 times per week)for 24 weeks.
1075252|NCT00625391|B2|Baseline|Green Tea Polyphenols (GTP)|Green tea polyphenols (GTP) group receiving 500 mg of GTP per day for 24 weeks.
1075253|NCT00625391|B1|Baseline|Placebo|Placebo group receiving 500 mg medicinal starch daily for 24 weeks.
1075254|NCT00625391|P4|Participant Flow|GTP + Tai Chi Group|GTP+Tai Chi group receiving both GTP and Tai Chi training for 24 weeks.
1075255|NCT00625391|P3|Participant Flow|Placebo + Tai Chi Group|Placebo+Tai Chi group receiving both placebo treatment and Tai Chi training (60-minute group exercise, 3 times per week)for 24 weeks.
1075256|NCT00625391|P2|Participant Flow|Green Tea Polyphenols (GTP) Group|Green tea polyphenols (GTP) group receiving 500 mg of GTP per day for 24 weeks.
1075257|NCT00625391|P1|Participant Flow|Placebo Group|Placebo group receiving 500 mg medicinal starch daily for 24 weeks.
1075258|NCT00625391|O4|Outcome|Green Tea Polyphenol + Tai Chi|GTP + Tai Chi: receiving 500 mg green tea polyphenols daily and group Tai Chi exercise (60 min/session, 3 sessions/week) for 24 weeks.
1075259|NCT00625391|O3|Outcome|Placebo + Tai Chi|Placebo + Tai Chi: receiving 500 mg medicinal starch daily and group Tai Chi exercise (60 min/session, 3 sessions/week) for 24 weeks
1075260|NCT00625391|O2|Outcome|Green Tea Polyphenols|GTP group receiving 500 mg green tea polyphenols daily for 24 weeks
1075261|NCT00625391|O1|Outcome|Placebo|"Placebo group receiving 500 mg medicinal starch daily for 24 weeks.~Green tea polyphenols (GTP) group receiving 500 mg of GTP per day for 24 weeks.~placebo+Tai Chi group receiving both placebo treatment and Tai Chi training (60-minute group exercise, 3 times per week)for 24 weeks.~GTP+Tai Chi group receiving both GTP and Tai Chi training for 24 weeks."
1075753|NCT00624052|B3|Baseline|Titrated Telmisartan 80mg and Amlodipine 10mg|
1075262|NCT00625391|O4|Outcome|Green Tea Polyphenol + Tai Chi|GTP + Tai Chi: receiving 500 mg green tea polyphenols daily and group Tai Chi exercise (60 min/session, 3 sessions/week) for 24 weeks.
1075263|NCT00625391|O3|Outcome|Placebo + Tai Chi|Placebo + Tai Chi: receiving 500 mg medicinal starch daily and group Tai Chi exercise (60 min/session, 3 sessions/week) for 24 weeks
1075264|NCT00625391|O2|Outcome|Green Tea Polyphenols|GTP group receiving 500 mg green tea polyphenols daily for 24 weeks
1075265|NCT00625391|O1|Outcome|Placebo|"Placebo group receiving 500 mg medicinal starch daily for 24 weeks.~Green tea polyphenols (GTP) group receiving 500 mg of GTP per day for 24 weeks.~placebo+Tai Chi group receiving both placebo treatment and Tai Chi training (60-minute group exercise, 3 times per week)for 24 weeks.~GTP+Tai Chi group receiving both GTP and Tai Chi training for 24 weeks."
1075266|NCT00625391|E4|Reported Event|GTP+TC|Green tea polyphenols at 500 mg daily and Tai Chi group exercise at 1 hour/session x 3 sessions/week for 24 weeks
1075267|NCT00625391|E3|Reported Event|Placebo+Tai Chi (TC)|Medicinal starch at 500 mg daily and Tai Chi group exercise at 1 hour/session x 3 sessions/week for 24 weeks
1075268|NCT00625391|E2|Reported Event|Green Tea Polyphenols (GTP)|Green tea polyphenols at 500 mg daily for 24 weeks
1075269|NCT00625391|E1|Reported Event|Placebo|Medicinal starch at 500 mg daily for 24 weeks
1075270|NCT00625365|B1|Baseline|DEFINITY (Perflutren Lipid Microsphere)|Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
1075271|NCT00625365|P1|Participant Flow|DEFINITY®|Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
1075272|NCT00625365|O1|Outcome|DEFINITY®|Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
1075273|NCT00625365|O1|Outcome|DEFINITY®|Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
1075274|NCT00625365|O1|Outcome|DEFINITY®|Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
1075275|NCT00625365|E1|Reported Event|DEFINITY®|Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
1075276|NCT00625183|B1|Baseline|Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
1075277|NCT00625183|P1|Participant Flow|Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
1075278|NCT00625183|O1|Outcome|Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
1075279|NCT00625183|O1|Outcome|Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
1075280|NCT00625183|O1|Outcome|Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
1075281|NCT00625183|O1|Outcome|Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
1075282|NCT00625183|E1|Reported Event|Capecitabine, Oxaliplatin, Selenomethionine and Radiation Ther|Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
1075283|NCT00625131|B3|Baseline|Total|Total of all reporting groups
1075284|NCT00625131|B2|Baseline|Arm 2|"Transdermal placebo patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
1075285|NCT00625131|B1|Baseline|Arm 1|"Transdermal nicotine patch~Nicotine: Delivered through transdermal nicotine patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
1075286|NCT00625131|P3|Participant Flow|Not Randomized|This arm includes patients who met screening criteria for entry into the randomization, but withdrew prior to randomization.
1075287|NCT00625131|P2|Participant Flow|Placebo Patch Group|"Transdermal placebo patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
1075288|NCT00625131|P1|Participant Flow|Active Nicotine Patch Group|"Transdermal nicotine patch~Nicotine: Delivered through transdermal nicotine patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
1075289|NCT00625131|O2|Outcome|Placebo Patch Group|"Transdermal placebo patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
1075290|NCT00625131|O1|Outcome|Active Nicotine Patch Group|"Transdermal nicotine patch~Nicotine: Delivered through transdermal nicotine patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
1075291|NCT00625131|O2|Outcome|Placebo Patch Group|"Transdermal placebo patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
1075292|NCT00625131|O1|Outcome|Active Nicotine Patch Group|"Transdermal nicotine patch~Nicotine: Delivered through transdermal nicotine patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
1075754|NCT00624052|B2|Baseline|Randomised Telmisartan 80mg and Amlodipine 10mg|
1075293|NCT00625131|O2|Outcome|Placebo Patch Group|"Transdermal placebo patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
1075294|NCT00625131|O1|Outcome|Active Nicotine Patch Group|"Transdermal nicotine patch~Nicotine: Delivered through transdermal nicotine patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
1075295|NCT00625131|E2|Reported Event|Placebo Patch Group|"Transdermal placebo patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
1075296|NCT00625131|E1|Reported Event|Active Nicotine Patch Group|"Transdermal nicotine patch~Nicotine: Delivered through transdermal nicotine patch~Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation~Bupropion SR: Antidepressant"
1075297|NCT00624832|B5|Baseline|Total|Total of all reporting groups
1075298|NCT00624832|B4|Baseline|Placebo Comparator|By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks.
1075299|NCT00624832|B3|Baseline|Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 301- 699 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
1075300|NCT00624832|B2|Baseline|Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
1075301|NCT00624832|B1|Baseline|Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
1075302|NCT00624832|P4|Participant Flow|Placebo Comparator|By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks.
1075303|NCT00624832|P3|Participant Flow|Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 301- 699 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
1075304|NCT00624832|P2|Participant Flow|Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
1075305|NCT00624832|P1|Participant Flow|Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
1075306|NCT00624832|O3|Outcome|Placebo Comparator|By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks.
1075307|NCT00624832|O2|Outcome|Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
1075308|NCT00624832|O1|Outcome|Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
1075309|NCT00624832|O3|Outcome|Placebo Comparator|By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks.
1075310|NCT00624832|O2|Outcome|Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
1075311|NCT00624832|O1|Outcome|Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL)|Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
1075312|NCT00624832|E4|Reported Event|Placebo Comparator|Placebo comparator
1075313|NCT00624832|E3|Reported Event|Xolair (IgE= 301- 699 IU/mL)|Patients with screening IgE levels= 301- 699 IU/mL. Participants received subcutaneous injections of Xolair(Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
1075314|NCT00624832|E2|Reported Event|Xolair (IgE= 700- 2000 IU/mL)|Patients with screening IgE levels= 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair(Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
1075315|NCT00624832|E1|Reported Event|Xolair (IgE= 30- 300 IU/mL)|Patients with screening IgE levels= 30-300 IU/mL. Participants received subcutaneous injections of Xolair(Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
1075316|NCT00624806|B3|Baseline|Total|Total of all reporting groups
1075755|NCT00624052|B1|Baseline|Telmisartan 40mg and Amlodipine 10mg|
1075317|NCT00624806|B2|Baseline|Weekly Group|"Weekly telephone calls to remind patients of recommended behaviors~Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers."
1075318|NCT00624806|B1|Baseline|Daily Group|"Daily telephone calls to remind patients of recommended behaviors~Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers."
1075319|NCT00624806|P2|Participant Flow|Arm 2|"Weekly telephone calls to remind patients of recommended behaviors~Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers."
1075320|NCT00624806|P1|Participant Flow|Arm 1|"Daily telephone calls to remind patients of recommended behaviors~Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers."
1075321|NCT00624806|O2|Outcome|Arm 2|"Weekly telephone calls to remind patients of recommended behaviors~Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers."
1075322|NCT00624806|O1|Outcome|Arm 1|"Daily telephone calls to remind patients of recommended behaviors~Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers."
1075323|NCT00624806|O2|Outcome|Arm 2|"Weekly telephone calls to remind patients of recommended behaviors~Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers."
1075324|NCT00624806|O1|Outcome|Arm 1|"Daily telephone calls to remind patients of recommended behaviors~Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers."
1075325|NCT00624806|O2|Outcome|Arm 2|"Weekly telephone calls to remind patients of recommended behaviors~Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers."
1075326|NCT00624806|O1|Outcome|Arm 1|"Daily telephone calls to remind patients of recommended behaviors~Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers."
1075327|NCT00624806|E2|Reported Event|Arm 2|"Weekly telephone calls to remind patients of recommended behaviors~Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers.~No adverse events reported."
1075328|NCT00624806|E1|Reported Event|Arm 1|"Daily telephone calls to remind patients of recommended behaviors~Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers.~No adverse events reported."
1075329|NCT00624780|B7|Baseline|Total|Total of all reporting groups
1075330|NCT00624780|B6|Baseline|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075331|NCT00624780|B5|Baseline|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075332|NCT00624780|B4|Baseline|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075333|NCT00624780|B3|Baseline|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075349|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075543|NCT00624559|O3|Outcome|Placebo, Low Sodium Diet|Blood pressure taken over 24 hours on the last day of the low sodium diet with and ambulatory blood pressure monitor
1075867|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
1075334|NCT00624780|B2|Baseline|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075335|NCT00624780|B1|Baseline|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075336|NCT00624780|P6|Participant Flow|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075337|NCT00624780|P5|Participant Flow|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075338|NCT00624780|P4|Participant Flow|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075339|NCT00624780|P3|Participant Flow|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075340|NCT00624780|P2|Participant Flow|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075350|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075544|NCT00624559|O2|Outcome|Celebrex, High Sodium Diet|Result taken on last day of a 7 day high salt diet
1075545|NCT00624559|O1|Outcome|Celebrex, Low Sodium Diet|Result taken at the end of 7 day low sodium diet
1075341|NCT00624780|P1|Participant Flow|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075342|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075343|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075344|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075345|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075346|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075347|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075348|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
1075533|NCT00624559|B1|Baseline|Celebrex, High Sodium|Each subject completes a normal sodium diet (3 days), a high salt diet (7 days), and a low salt diet (7 days) while taking either a placebo or celebrex (each trial is 17 days long). Each subject completes 2 full 17 day trials (one month 'washout' between each trial); one time taking the placebo and one taking celebrex (randomized).
1075351|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075352|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075353|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075354|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075355|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075356|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075357|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
1075358|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075359|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075534|NCT00624559|P4|Participant Flow|Placebo, High Sodium|Placebo pill taken twice per day over the course of the diet
1075360|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075361|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075362|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075363|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075364|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075365|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075366|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
1075367|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075368|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075535|NCT00624559|P3|Participant Flow|Placebo, Low Sodium|Placebo pill taken twice per day over the course of the diet
1075369|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075370|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075371|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075372|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075373|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075374|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075375|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
1075376|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075377|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075536|NCT00624559|P2|Participant Flow|Celebrex, Low Sodium|100 mg Celebrex, twice per day for 7 days on low sodium diet
1075378|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075379|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075380|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075381|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075382|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075383|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075384|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
1075385|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075386|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075546|NCT00624559|E4|Reported Event|Placebo, High Sodium|Placebo pill taken twice per day over the course of the diet
1075387|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075388|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075389|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075390|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075391|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075392|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075393|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
1075394|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075395|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075547|NCT00624559|E3|Reported Event|Placebo, Low Sodium|Placebo pill taken twice per day over the course of the diet
1075396|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075397|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075398|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075399|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075400|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075401|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075402|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
1075403|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075404|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075548|NCT00624559|E2|Reported Event|Celebrex, Low Sodium|100 mg Celebrex, twice per day for 7 days on low sodium diet
1075405|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
1075406|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075407|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075408|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075409|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075410|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075411|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075412|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075413|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075868|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
1075869|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
1075414|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
1075415|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075416|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075417|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
1075418|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075419|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075420|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075421|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075422|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075423|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075577|NCT00624520|E1|Reported Event|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
1075424|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075425|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075426|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
1075427|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075428|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075429|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
1075430|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075431|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075432|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075442|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075578|NCT00624468|B3|Baseline|Total|Total of all reporting groups
1075579|NCT00624468|B2|Baseline|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
1075433|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075434|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075435|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075436|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075437|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075438|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
1075439|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075440|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075441|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
1075537|NCT00624559|P1|Participant Flow|Celebrex, High Sodium|Each subject completes a normal sodium diet (3 days), a high salt diet (7 days), and a low salt diet (7 days) while taking either a placebo or celebrex (each trial is 17 days long). Each subject completes 2 full 17 day trials (one month 'washout' between each trial); one time taking the placebo and one taking celebrex (randomized).
1075443|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075444|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075445|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075446|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075447|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075448|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075449|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075450|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
1075451|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075870|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
1075871|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
1075452|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075453|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
1075454|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075455|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075456|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075457|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075458|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075459|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075460|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075538|NCT00624559|O4|Outcome|Placebo, High Sodium Diet|Blood pressure taken with an ambulatory blood pressure monitor, over 24 hours on the last day of the high sodium diet
1075539|NCT00624559|O3|Outcome|Placebo, Low Sodium Diet|Blood pressure taken over 24 hours on the last day of the low sodium diet with and ambulatory blood pressure monitor
1075461|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075462|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
1075463|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075464|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075465|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
1075466|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075467|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075468|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075469|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075470|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075872|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
1075471|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075472|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075473|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075474|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075475|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075476|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075477|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075478|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075540|NCT00624559|O2|Outcome|Celebrex, High Sodium Diet|Result taken on last day of a 7 day high salt diet
1075873|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
1075479|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075480|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
1075481|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075482|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075483|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
1075484|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075485|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075486|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
1075487|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075488|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075489|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
1075541|NCT00624559|O1|Outcome|Celebrex, Low Sodium Diet|Result taken at the end of 7 day low sodium diet
1075542|NCT00624559|O4|Outcome|Placebo, High Sodium Diet|Blood pressure taken with an ambulatory blood pressure monitor, over 24 hours on the last day of the high sodium diet
1075490|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075491|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075492|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075493|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075494|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075495|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075496|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075497|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075507|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
1075874|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
1075875|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
1075498|NCT00624780|O6|Outcome|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075499|NCT00624780|O5|Outcome|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075500|NCT00624780|O4|Outcome|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6 fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075501|NCT00624780|O3|Outcome|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075502|NCT00624780|O2|Outcome|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075503|NCT00624780|O1|Outcome|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075504|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
1075505|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075506|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075876|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
1075877|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
1075508|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075509|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075510|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
1075511|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075512|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075513|NCT00624780|O3|Outcome|Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12.
1075514|NCT00624780|O2|Outcome|Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075515|NCT00624780|O1|Outcome|Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12.
1075516|NCT00624780|E6|Reported Event|Lorazepam, Placebo|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Lorazepam was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075517|NCT00624780|E5|Reported Event|Lorazepam, Lorazepam|Period 1 (treatment optimization): Lorazepam capsule 2 mg/day orally twice daily in 2 equally divided doses in Week 1, lorazepam capsule 3 mg/day orally in 2 divided doses (1 mg in morning, 2 mg at night) in Week 2 and 3, during 3-week upward titration. Flexible dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 12. Period 2 (fixed dosing): Continued lorazepam capsule 3 or 4 mg/day orally twice daily in 2 divided doses (1 or 2 mg in morning, 2 mg at night) up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075528|NCT00624585|E1|Reported Event|Dasatinib Dose Escalation|Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
1075518|NCT00624780|E4|Reported Event|Pregabalin Low Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075519|NCT00624780|E3|Reported Event|Pregabalin Low Dose, Pregabalin Low Dose|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses during 3-week upward titration. Flexible dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 150 mg/day or 300 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075520|NCT00624780|E2|Reported Event|Pregabalin High Dose, Placebo|Period 1 (treatment optimization): Pregabalin capsule 150 mg/day orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Pregabalin was discontinued with a blinded dose tapering over 1-week followed by matching placebo capsule orally twice daily up to Week 24. Period 3 (treatment discontinuation): Continued matching placebo capsule orally twice daily for 1 week (Week 25). Participants were followed-up after 1 week (Week 26).
1075521|NCT00624780|E1|Reported Event|Pregabalin High Dose, Pregabalin High Dose|Period 1 (treatment optimization): Pregabalin capsule 150 milligram per day (mg/day) orally twice daily in 2 equally divided doses in Week 1, pregabalin capsule 300 mg/day orally twice daily in 2 equally divided doses in Week 2 and pregabalin capsule 450 mg/day orally twice daily in 2 equally divided doses in Week 3 during 3-week upward titration. Flexible dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses depending on efficacy and tolerability up to Week 6. If participant had an adequate response at Week 6, fixed dosing of pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 12. Period 2 (fixed dosing): Continued pregabalin capsule 450 mg/day or 600 mg/day orally twice daily in 2 equally divided doses up to Week 24. Period 3 (treatment discontinuation): A 1-week blinded dose tapering period (Week 25). Participants were followed-up after 1 week (Week 26).
1075522|NCT00624585|B1|Baseline|Dasatinib Dose Escalation|Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
1075523|NCT00624585|P1|Participant Flow|Dasatinib Dose Escalation|Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
1075524|NCT00624585|O1|Outcome|Dasatinib Dose Escalation|Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
1075525|NCT00624585|O1|Outcome|Dasatinib Dose Escalation|Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
1075526|NCT00624585|O1|Outcome|Dasatinib Dose Escalation|Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
1075527|NCT00624585|O1|Outcome|Dasatinib Dose Escalation|Patients were started on dasatinib at a continuous oral daily dose of 100 mg per day. At 8 weeks, if the initial dose was well tolerated and patient had not achieved a partial response, the dose could be increased to 150 mg per day. All patients were followed per protocol for a total core period of 16 weeks from the first dose. Responding patients could continue dasatinib treatment for up to 48 weeks in the absence of treatment failure, disease progression, limiting toxicity or death. Patients continuing after 48 weeks will be enrolled in a separate extension study for future follow up.
1075529|NCT00624559|B5|Baseline|Total|Total of all reporting groups
1075549|NCT00624559|E1|Reported Event|Celebrex, High Sodium|Each subject completes a normal sodium diet (3 days), a high salt diet (7 days), and a low salt diet (7 days) while taking either a placebo or celebrex (each trial is 17 days long). Each subject completes 2 full 17 day trials (one month 'washout' between each trial); one time taking the placebo and one taking celebrex (randomized).
1075550|NCT00624520|B3|Baseline|Total|Total of all reporting groups
1075551|NCT00624520|B2|Baseline|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
1075552|NCT00624520|B1|Baseline|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
1075553|NCT00624520|P2|Participant Flow|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
1075554|NCT00624520|P1|Participant Flow|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
1075555|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
1075556|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
1075557|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
1075558|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
1075559|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
1075560|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
1075561|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
1075562|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
1075563|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
1075564|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
1075565|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
1075566|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
1075567|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
1075568|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
1075569|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
1075570|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
1075571|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
1075572|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
1075573|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
1075574|NCT00624520|O2|Outcome|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
1075575|NCT00624520|O1|Outcome|Cognitive Behavioral Stress Management|"10 week program of Cognitive Behavioral Stress Management (CBSM) group sessions~Cognitive Behavioral Stress Management (CBSM): 10 week program of weekly CBSM therapy group sessions"
1075576|NCT00624520|E2|Reported Event|Patient Education|"10 week program of once weekly Patient Education group sessions~Patient Education: 10 week program of Patient Education group sessions, involving presentations of educational materials relating to heart disease."
1075580|NCT00624468|B1|Baseline|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
1075581|NCT00624468|P4|Participant Flow|Atacicept: SFU Period|Subjects who received atacicept in double-blind period were included in SFU period (60 weeks) following premature termination of the trial.
1075582|NCT00624468|P3|Participant Flow|Placebo: SFU Period|Subjects who received placebo matched to atacicept in double-blind period were included in safety follow-up (SFU) period (60 weeks) following premature termination of the trial.
1075583|NCT00624468|P2|Participant Flow|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
1075584|NCT00624468|P1|Participant Flow|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
1075585|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
1075586|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
1075587|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
1075588|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
1075589|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
1075590|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
1075591|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
1075592|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
1075593|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
1075594|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
1075595|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
1075596|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
1075597|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
1075598|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
1075599|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
1075600|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
1075601|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
1075602|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
1075603|NCT00624468|O2|Outcome|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
1075604|NCT00624468|O1|Outcome|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
1075605|NCT00624468|E4|Reported Event|Atacicept: SFU Period|Participants who received atacicept in double-blind period were included in SFU period (60 weeks) following premature termination of the trial.
1075606|NCT00624468|E3|Reported Event|Placebo: SFU Period|Participants who received placebo matched to atacicept in double-blind period were included in SFU period (60 weeks) following premature termination of the trial.
1075607|NCT00624468|E2|Reported Event|Atacicept: Double-blind Period|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
1075608|NCT00624468|E1|Reported Event|Placebo: Double-blind Period|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
1075609|NCT00624442|B6|Baseline|Total|Total of all reporting groups
1075610|NCT00624442|B5|Baseline|Cohort 5|2 treatment periods with a 72 hour infusion. The 2 treatment periods are randomly assigned and consist of 1 dose level of CK-1827452 (with dose de-escalation possible depending on tolerability) and 1 placebo treatment. Treatment period 2 occurs at least 7 days after the conclusion of period 1.
1075611|NCT00624442|B4|Baseline|Cohort 4|4 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the sequence. Treatment periods occur at least 7 days apart.
1075878|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
1075879|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
1075612|NCT00624442|B3|Baseline|Cohort 3|4 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
1075613|NCT00624442|B2|Baseline|Cohort 2|4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
1075614|NCT00624442|B1|Baseline|Cohort 1|4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
1075615|NCT00624442|P5|Participant Flow|Cohort 5|2 treatment periods with a 72 hour infusion. The 2 treatment periods are randomly assigned and consist of 1 dose level of CK-1827452 (with dose de-escalation possible depending on tolerability) and 1 placebo treatment. Treatment period 2 occurs at least 7 days after the conclusion of period 1.
1075616|NCT00624442|P4|Participant Flow|Cohort 4|4 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the sequence. Treatment periods occur at least 7 days apart.
1075617|NCT00624442|P3|Participant Flow|Cohort 3|4 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
1075618|NCT00624442|P2|Participant Flow|Cohort 2|4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
1075619|NCT00624442|P1|Participant Flow|Cohort 1|4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
1075620|NCT00624442|O6|Outcome|>500 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
1075621|NCT00624442|O5|Outcome|>400-500 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
1075622|NCT00624442|O4|Outcome|>300-400 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
1075623|NCT00624442|O3|Outcome|>200-300 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
1075624|NCT00624442|O2|Outcome|>100-200 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
1075625|NCT00624442|O1|Outcome|>0-100 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
1075626|NCT00624442|O6|Outcome|>500 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
1075627|NCT00624442|O5|Outcome|>400-500 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
1075628|NCT00624442|O4|Outcome|>300-400 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
1075629|NCT00624442|O3|Outcome|>200-300 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
1075630|NCT00624442|O2|Outcome|>100-200 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
1075631|NCT00624442|O1|Outcome|>0-100 ng/mL|Measurements pooled by plasma concentration of CK-1827452 at time of pharmacodynamic measure. Measurements at any dose level or timepoint could contribute to this bin.
1075632|NCT00624442|E12|Reported Event|Cohort 5, Loading Dose of 1.0 mg/kg/hr|Loading dose is first hour of IV infusion.
1075633|NCT00624442|E11|Reported Event|Cohort 5, Loading Dose of 0.75 mg/kg/hr|Loading dose is first hour of IV infusion.
1075634|NCT00624442|E10|Reported Event|Cohorts 3 and 4, Loading Dose of 1.0 mg/kg/hr|Loading dose is first hour of IV infusion.
1075635|NCT00624442|E9|Reported Event|Cohorts 3 and 4, Loading Dose of 0.5 mg/kg/hr|Loading dose is first hour of IV infusion.
1075636|NCT00624442|E8|Reported Event|Cohorts 3 and 4, Loading Dose of 0.25 mg/kg/hr|Loading dose is first hour of IV infusion.
1075637|NCT00624442|E7|Reported Event|Cohort 2, Loading Dose of 2.2 mg/kg/hr|Loading dose is first hour of IV infusion. This dose level occurred in 1 patient due to accidental overdose.
1075638|NCT00624442|E6|Reported Event|Cohorts 1 and/or 2, Loading Dose of 1.0 mg/kg/hr|Loading dose is first hour of IV infusion.
1075639|NCT00624442|E5|Reported Event|Cohorts 1 and/or 2, Loading Dose of 0.75 mg/kg/hr|Loading dose is the first hour of IV infusion.
1075640|NCT00624442|E4|Reported Event|Cohorts 1 and/or 2, Loading Dose of 0.5 mg/kg/hr|Loading dose is the first hour of IV infusion.
1075641|NCT00624442|E3|Reported Event|Cohorts 1 and/or 2, Loading Dose of 0.25 mg/kg/hr|Loading dose is the first hour of IV infusion.
1075642|NCT00624442|E2|Reported Event|Cohorts 1 and/or 2, Loading Dose of 0.125 mg/kg/hr|Loading dose is the first hour of IV infusion.
1075643|NCT00624442|E1|Reported Event|Placebo|
1075644|NCT00624416|B1|Baseline|Prednisolone and Isoproteronol|Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
1075645|NCT00624416|P1|Participant Flow|Prednisolone and Isoproteronol|Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
1075741|NCT00624065|B2|Baseline|Carvedilol CR + Lisinopril|Carvedilol controlled release (CR) + lisinopril (20 + 10, 20 + 20, or 40 + 20 mg once daily)
1075646|NCT00624416|O1|Outcome|Prednisolone and Isoproteronol|Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
1075647|NCT00624416|O1|Outcome|Prednisolone and Isoproteronol|Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
1075648|NCT00624416|O1|Outcome|Prednisolone and Isoproteronol|Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
1075649|NCT00624416|E1|Reported Event|Prednisolone and Isoproteronol|Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
1075650|NCT00624377|B1|Baseline|Spiriva 18µg With HandiHaler Device on COPD Patients|
1075651|NCT00624377|P1|Participant Flow|Spiriva 18µg With HandiHaler Device on COPD Patients|
1075652|NCT00624377|O1|Outcome|Spiriva 18µg With HandiHaler Device on COPD Patients|
1075653|NCT00624377|O1|Outcome|Spiriva 18µg With HandiHaler Device on COPD Patients|
1075654|NCT00624377|O1|Outcome|Spiriva 18µg With HandiHaler Device on COPD Patients|
1075655|NCT00624377|O1|Outcome|Spiriva 18µg With HandiHaler Device on COPD Patients|
1075656|NCT00624377|O1|Outcome|Spiriva 18µg With HandiHaler Device on COPD Patients|
1075657|NCT00624377|O1|Outcome|Spiriva 18µg With HandiHaler Device on COPD Patients|
1075658|NCT00624377|O1|Outcome|Spiriva 18µg With HandiHaler Device on COPD Patients|
1075659|NCT00624377|O1|Outcome|Spiriva 18µg With HandiHaler Device on COPD Patients|
1075660|NCT00624377|E1|Reported Event|Spiriva 18µg With HandiHaler Device on COPD Patients|
1075661|NCT00624338|B4|Baseline|Total|Total of all reporting groups
1075662|NCT00624338|B3|Baseline|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
1075663|NCT00624338|B2|Baseline|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
1075664|NCT00624338|B1|Baseline|Atacicept 75 mg|75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
1075665|NCT00624338|P3|Participant Flow|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
1075666|NCT00624338|P2|Participant Flow|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
1075667|NCT00624338|P1|Participant Flow|Atacicept 75 mg|75 milligram (mg) atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
1075668|NCT00624338|O3|Outcome|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
1075669|NCT00624338|O2|Outcome|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
1075670|NCT00624338|O1|Outcome|Atacicept 75 mg|75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
1075671|NCT00624338|O3|Outcome|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
1075672|NCT00624338|O2|Outcome|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
1075673|NCT00624338|O1|Outcome|Atacicept 75 mg|75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
1075674|NCT00624338|O3|Outcome|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
1075675|NCT00624338|O2|Outcome|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
1075676|NCT00624338|O1|Outcome|Atacicept 75 mg|75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
1075677|NCT00624338|O3|Outcome|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
1075678|NCT00624338|O2|Outcome|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
1075679|NCT00624338|O1|Outcome|Atacicept 75 mg|75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
1075680|NCT00624338|O3|Outcome|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
1075681|NCT00624338|O2|Outcome|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
1075742|NCT00624065|B1|Baseline|Lisinopril|Lisinopril monotherapy (10, 20, or 40 mg once daily)
1075682|NCT00624338|O1|Outcome|Atacicept 75 mg|75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
1075683|NCT00624338|E3|Reported Event|Placebo|Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
1075684|NCT00624338|E2|Reported Event|Atacicept 150 mg|150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
1075685|NCT00624338|E1|Reported Event|Atacicept 75 mg|75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
1075686|NCT00624286|B3|Baseline|Total|Total of all reporting groups
1075687|NCT00624286|B2|Baseline|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1075688|NCT00624286|B1|Baseline|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1075689|NCT00624286|P2|Participant Flow|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1075690|NCT00624286|P1|Participant Flow|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1075691|NCT00624286|O2|Outcome|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1075692|NCT00624286|O1|Outcome|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1075693|NCT00624286|O2|Outcome|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1075694|NCT00624286|O1|Outcome|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1075695|NCT00624286|E2|Reported Event|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1075696|NCT00624286|E1|Reported Event|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1075697|NCT00624234|B7|Baseline|Total|Total of all reporting groups
1075698|NCT00624234|B6|Baseline|Waitlist Control|These are children who have reading disabilities (without NF) but did not receive intervention until after the trial.
1075699|NCT00624234|B5|Baseline|IRD-Tutoring Program 2|"These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program II~Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity."
1075700|NCT00624234|B4|Baseline|IRD- Tutoring Program 1|"These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program I~Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design."
1075701|NCT00624234|B3|Baseline|Typically Developing Readers|Control group--children who do not have reading problems
1075743|NCT00624065|P2|Participant Flow|Carvedilol CR + Lisinopril|Carvedilol controlled release (CR) + lisinopril (20 + 10, 20 + 20, or 40 + 20 mg once daily)
1075744|NCT00624065|P1|Participant Flow|Lisinopril|Lisinopril monotherapy (10, 20, or 40 mg once daily)
1075745|NCT00624065|O2|Outcome|Carvedilol CR + Lisinopril|Carvedilol controlled release (CR) + lisinopril (20 + 10, 20 + 20, or 40 + 20 mg once daily)
1075746|NCT00624065|O1|Outcome|Lisinopril|Lisinopril monotherapy (10, 20, or 40 mg once daily)
1075702|NCT00624234|B2|Baseline|NF-Tutoring Program 2|"Tutoring Program II~Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity."
1075703|NCT00624234|B1|Baseline|NF-Tutoring Program 1|"Tutoring Program I~Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design."
1075704|NCT00624234|P6|Participant Flow|Waitlist Control|These are children who have reading disabilities (without NF) but did not receive intervention until after the trial.
1075705|NCT00624234|P5|Participant Flow|IRD-Tutoring Program 2|"These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program II~Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity."
1075706|NCT00624234|P4|Participant Flow|IRD- Tutoring Program 1|"These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program I~Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design."
1075707|NCT00624234|P3|Participant Flow|Typically Developing Readers|Control group--children who do not have reading problems
1075708|NCT00624234|P2|Participant Flow|NF-Tutoring Program 2|"Tutoring Program II~Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity."
1075709|NCT00624234|P1|Participant Flow|NF-Tutoring Program 1|"Tutoring Program I~Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design."
1075710|NCT00624234|O6|Outcome|Waitlist Control|These are children who have reading disabilities (without NF) but did not receive intervention until after the trial.
1075711|NCT00624234|O5|Outcome|IRD-Tutoring Program 2|"These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program II~Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity."
1075712|NCT00624234|O4|Outcome|IRD- Tutoring Program 1|"These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program I~Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design."
1075713|NCT00624234|O3|Outcome|Typically Developing Readers|Control group--children who do not have reading problems
1075714|NCT00624234|O2|Outcome|NF-Tutoring Program 2|"Tutoring Program II~Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity."
1075715|NCT00624234|O1|Outcome|NF-Tutoring Program 1|"Tutoring Program I~Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design."
1075716|NCT00624234|E6|Reported Event|Waitlist Control|These are children who have reading disabilities (without NF) but did not receive intervention until after the trial.
1075747|NCT00624065|O2|Outcome|Carvedilol CR + Lisinopril|Carvedilol controlled release (CR) + lisinopril (20 + 10, 20 + 20, or 40 + 20 mg once daily)
1075717|NCT00624234|E5|Reported Event|IRD-Tutoring Program 2|These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program II Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity.
1075718|NCT00624234|E4|Reported Event|IRD-Tutoring Program 1|These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program I Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design.
1075719|NCT00624234|E3|Reported Event|Typically Developing Readers|Control group--children who do not have reading problems
1075720|NCT00624234|E2|Reported Event|NF-Tutoring Program 2|"Tutoring Program II~Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity."
1075721|NCT00624234|E1|Reported Event|NF-Tutoring Program 1|"Tutoring Program I~Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design."
1075722|NCT00624221|B3|Baseline|Total|Total of all reporting groups
1075723|NCT00624221|B2|Baseline|Surgeon Dissected Grafts|The surgeon dissected the donor grafts used for the transplant procedures.
1075724|NCT00624221|B1|Baseline|Eye Bank Pre-cut Grafts|An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.
1075725|NCT00624221|P2|Participant Flow|Surgeon Dissected Grafts|The surgeon dissected the donor grafts used for the transplant procedures.
1075726|NCT00624221|P1|Participant Flow|Eye Bank Pre-cut Grafts|An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.
1075727|NCT00624221|O2|Outcome|Surgeon Dissected Grafts|The surgeon dissected the donor grafts used for the transplant procedures.
1075728|NCT00624221|O1|Outcome|Eye Bank Pre-cut Grafts|An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.
1075729|NCT00624221|E2|Reported Event|Surgeon Dissected Grafts|The surgeon dissected the donor grafts used for the transplant procedures.
1075730|NCT00624221|E1|Reported Event|Eye Bank Pre-cut Grafts|An Eye bank pre-cut the donor grafts used for the corneal transplant procedures.
1075731|NCT00624195|B3|Baseline|Total|Total of all reporting groups
1075732|NCT00624195|B2|Baseline|Non-CNS-targeted|Subjects in the non-CNS-T (Comparison) arm will be randomized to receive a regimen designed to suppress plasma Viral Load, but not to expected to have targeted CNS penetration.
1075733|NCT00624195|B1|Baseline|CNS-targeted|CNS-T will comprise two components: 1) initial selection of agents to optimize CNS penetration of the overall regimen; and 2) modification of the regimen if an interim pharmacokinetic (PK) assessment determines that plasma ARV exposure is not appropriate (overdosing, underdosing).
1075734|NCT00624195|P2|Participant Flow|Non-CNS-targeted|"Subjects in the non-CNS-T (Comparison) arm will be randomized to receive a regimen designed to suppress plasma Viral Load, but not to expected to have targeted CNS penetration.~Possible regimens include combinations of these FDA approved antiretroviral agents: Efavirenz/Emtricitabine/Tenofovir, Lamivudine/Zidovudine, Emtricitabine, Lamivudine, Abacavir/Lamivudine, Zidovudine, Abacavir/Lamivudine/Zidovudine, Emtricitabine/Tenofovir, Tenofovir, Abacavir, Etravirine, Delavirdine, Efavirenz, Nevirapine, Amprenavir, Tipranavir, Saquinavir, Lopinavir/ritonavir, Fosamprenavir, Ritonavir, Darunavir, Atazanavir, Nelfinavir, Enfuvirtide, Maraviroc, Raltegravir"
1075735|NCT00624195|P1|Participant Flow|CNS-targeted|"CNS-T will comprise two components: 1) initial selection of agents to optimize CNS penetration of the overall regimen; and 2) modification of the regimen if an interim pharmacokinetic (PK) assessment determines that plasma ARV exposure is not appropriate (overdosing, under dosing).~Possible regimens include combinations of these FDA approved antiretroviral agents: Efavirenz/Emtricitabine/Tenofovir, Lamivudine/Zidovudine, Emtricitabine, Lamivudine, Abacavir/Lamivudine, Zidovudine, Abacavir/Lamivudine/Zidovudine, Emtricitabine/Tenofovir, Tenofovir, Abacavir, Etravirine, Delavirdine, Efavirenz, Nevirapine, Amprenavir, Tipranavir, Saquinavir, Lopinavir/ritonavir, Fosamprenavir, Ritonavir, Darunavir, Atazanavir, Nelfinavir, Enfuvirtide, Maraviroc, Raltegravir"
1075736|NCT00624195|O2|Outcome|Non-CNS-targeted|Subjects in the non-CNS-T (Comparison) arm will be randomized to receive a regimen designed to suppress plasma Viral Load, but not to expected to have targeted CNS penetration.
1075737|NCT00624195|O1|Outcome|CNS-targeted|CNS-T will comprise two components: 1) initial selection of agents to optimize CNS penetration of the overall regimen; and 2) modification of the regimen if an interim pharmacokinetic (PK) assessment determines that plasma ARV exposure is not appropriate (overdosing, underdosing).
1075738|NCT00624195|E2|Reported Event|Non-CNS-targeted|Subjects in the non-CNS-T (Comparison) arm will be randomized to receive a regimen designed to suppress plasma Viral Load, but not to expected to have targeted CNS penetration.
1075739|NCT00624195|E1|Reported Event|CNS-targeted|CNS-T will comprise two components: 1) initial selection of agents to optimize CNS penetration of the overall regimen; and 2) modification of the regimen if an interim pharmacokinetic (PK) assessment determines that plasma ARV exposure is not appropriate (overdosing, underdosing).
1075740|NCT00624065|B3|Baseline|Total|Total of all reporting groups
1075880|NCT00623779|O1|Outcome|AZD0837 150 mg|AZD0837 150 mg
1075756|NCT00624052|P4|Participant Flow|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|Patients who were on either telmisartan 40 mg or 80mg and amlodipine 10mg plus another antihypertensive medication at their last study visit
1075757|NCT00624052|P3|Participant Flow|Titrated Telmisartan 80mg and Amlodipine 10mg|Patients who were randomised to telmisartan 40mg and amlodipine 10mg but were titrated to telmisartan 80mg and amlodipine 10mg and were on this dose at their last study visit
1075758|NCT00624052|P2|Participant Flow|Randomised Telmisartan 80mg and Amlodipine 10mg|Patients who were randomised to telmisartan 80mg and amlodipine 10mg and were on this dose at their last study visit
1075759|NCT00624052|P1|Participant Flow|Telmisartan 40mg and Amlodipine 10mg|Patients who were randomised to telmisartan 40mg and amlodipine 10mg and were on this dose at their last study visit
1075760|NCT00624052|O3|Outcome|Pre-titration: Total|
1075761|NCT00624052|O2|Outcome|Pre-titration: No (DBP>=90 mmHg)|
1075762|NCT00624052|O1|Outcome|Pre-titration: Yes (DBP<90 mmHg)|
1075763|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
1075764|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
1075765|NCT00624052|O3|Outcome|Pre-antihypertensive: Total|
1075766|NCT00624052|O2|Outcome|Pre-antihypertensive: No (DBP>=90 mmHg)|
1075767|NCT00624052|O1|Outcome|Pre-antihypertensive: Yes (DBP<90 mmHg)|
1075768|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
1075769|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
1075770|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
1075771|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
1075772|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
1075773|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
1075774|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
1075775|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
1075776|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
1075777|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
1075778|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
1075779|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
1075780|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
1075781|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
1075782|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
1075783|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
1075784|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
1075785|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
1075786|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
1075787|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
1075788|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
1075789|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
1075790|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
1075791|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
1075792|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
1075793|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
1075794|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
1075795|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
1075796|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
1075797|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
1075798|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
1075799|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
1075800|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
1075801|NCT00624052|O4|Outcome|Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on|
1075802|NCT00624052|O3|Outcome|Titrated Telmisartan 80mg and Amlodipine 10mg|
1075803|NCT00624052|O2|Outcome|Randomised Telmisartan 80mg and Amlodipine 10mg|
1075804|NCT00624052|O1|Outcome|Telmisartan 40mg and Amlodipine 10mg|
1075805|NCT00624052|E2|Reported Event|Telmisartan 80mg and Amlodipine 10mg|The 611 participants in the telmisartan 80mg/amlodipine 10mg (T80/A10) group include 436 patients in the randomised T80/A10 group + 91 patients in the uptitrated T80/A10 group + XX patients in the T80/A10 + add-on group
1075806|NCT00624052|E1|Reported Event|Telmisartan 40mg and Amlodipine 10mg|The 838 participants in the telmisartan 40mg/amlodipine 10mg group includes all participants
1075807|NCT00623974|B5|Baseline|Total|Total of all reporting groups
1075808|NCT00623974|B4|Baseline|Teriparatide 60 Mcg|Teriparatide at 60 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
1075809|NCT00623974|B3|Baseline|Teriparatide 40 Mcg|Teriparatide at 40 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
1075810|NCT00623974|B2|Baseline|Teriparatide 20 Mcg|Teriparatide at 20 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
1075811|NCT00623974|B1|Baseline|Calcium + Calcitriol|1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
1075812|NCT00623974|P4|Participant Flow|Teriparatide 60 Mcg|Teriparatide at 60 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
1075813|NCT00623974|P3|Participant Flow|Teriparatide 40 Mcg|Teriparatide at 40 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
1075814|NCT00623974|P2|Participant Flow|Teriparatide 20 Mcg|Teriparatide at 20 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
1075815|NCT00623974|P1|Participant Flow|Calcium + Calcitriol|1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
1075816|NCT00623974|O4|Outcome|Teriparatide 60 Mcg|Teriparatide at 60 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
1075817|NCT00623974|O3|Outcome|Teriparatide 40 Mcg|Teriparatide at 40 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
1075818|NCT00623974|O2|Outcome|Teriparatide 20 Mcg|Teriparatide at 20 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
1075819|NCT00623974|O1|Outcome|Calcium + Calcitriol|1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
1075820|NCT00623974|E4|Reported Event|Teriparatide 60 Mcg|Teriparatide at 60 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
1075821|NCT00623974|E3|Reported Event|Teriparatide 40 Mcg|Teriparatide at 40 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
1075822|NCT00623974|E2|Reported Event|Teriparatide 20 Mcg|Teriparatide at 20 mcg; and 1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
1075823|NCT00623974|E1|Reported Event|Calcium + Calcitriol|1000 milligrams Calcium + 0.25 micrograms Calcitriol orally every 12 hours
1075824|NCT00623935|B1|Baseline|Fludarabine Plus Busulfan|"Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days)~Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant.~Patients will undergo an allogeneic stem cell transplant from related or unrelated donor."
1075825|NCT00623935|P1|Participant Flow|Fludarabine Plus Busulfan|"Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days)~Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant.~Patients will undergo an allogeneic stem cell transplant from related or unrelated donor."
1075826|NCT00623935|O1|Outcome|Fludarabine Plus Busulfan|"Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days)~Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant.~Patients will undergo an allogeneic stem cell transplant from related or unrelated donor."
1075827|NCT00623935|O1|Outcome|Fludarabine Plus Busulfan|"Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days)~Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant.~Patients will undergo an allogeneic stem cell transplant from related or unrelated donor."
1075828|NCT00623935|E1|Reported Event|Fludarabine Plus Busulfan|"Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days)~Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant.~Patients will undergo an allogeneic stem cell transplant from related or unrelated donor."
1075829|NCT00623831|B3|Baseline|Total|Total of all reporting groups
1075830|NCT00623831|B2|Baseline|Cohort 2|Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU [dose level 6]) that was determined to be the pyrogenic dose level in Cohort 1.
1075831|NCT00623831|B1|Baseline|Cohort 1|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
1075832|NCT00623831|P2|Participant Flow|Cohort 2|Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU [dose level 6]) that was determined to be the pyrogenic dose level in Cohort 1.
1075833|NCT00623831|P1|Participant Flow|Cohort 1|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a dose-limiting toxicity (DLT) until the desired pyrogenic effect was observed.
1075834|NCT00623831|O2|Outcome|Cohort 2 (Tumor Response Analysis Set)|Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU [dose level 6]) that was determined to be the pyrogenic dose level in Cohort 1.
1075835|NCT00623831|O1|Outcome|Cohort 1 (Tumor Response Analysis Set)|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
1075836|NCT00623831|O1|Outcome|Cohort 1 (Immune Response Analysis Set)|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
1075837|NCT00623831|O1|Outcome|Cohort 1 (Safety Analysis Set)|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
1075838|NCT00623831|O2|Outcome|Cohort 2 (Safety Analysis Set)|Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU [dose level 6]) that was determined to be the pyrogenic dose level in Cohort 1.
1075839|NCT00623831|O1|Outcome|Cohort 1 (Safety Analysis Set)|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
1075840|NCT00623831|E2|Reported Event|Cohort 2|Subjects received MBV twice weekly by intralesional (preferred) or subcutaneous (if intralesional not possible) injection at the fixed dose (60,800 EU [dose level 6]) that was determined to be the pyrogenic dose level in Cohort 1.
1075841|NCT00623831|E1|Reported Event|Cohort 1|Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
1075842|NCT00623805|B3|Baseline|Total|Total of all reporting groups
1075881|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
1075882|NCT00623779|O2|Outcome|AZD0837 300 mg|AZD0837 300 mg
1075843|NCT00623805|B2|Baseline|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
1075844|NCT00623805|B1|Baseline|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
1075845|NCT00623805|P2|Participant Flow|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
1075846|NCT00623805|P1|Participant Flow|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
1075847|NCT00623805|O2|Outcome|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
1075848|NCT00623805|O1|Outcome|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
1075849|NCT00623805|O2|Outcome|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
1075850|NCT00623805|O1|Outcome|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
1075851|NCT00623805|O2|Outcome|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
1075852|NCT00623805|O1|Outcome|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
1075853|NCT00623805|O2|Outcome|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
1075854|NCT00623805|O1|Outcome|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
1075855|NCT00623805|O2|Outcome|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
1075856|NCT00623805|O1|Outcome|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
1075857|NCT00623805|E2|Reported Event|Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
1075858|NCT00623805|E1|Reported Event|Bevacizumab+Capecitabine+Oxaliplatin|Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
1075859|NCT00623779|B4|Baseline|Total|Total of all reporting groups
1075860|NCT00623779|B3|Baseline|Standard Therapy|Standard Therapy
1075861|NCT00623779|B2|Baseline|AZD0837 300 mg|AZD0837 300 mg
1075862|NCT00623779|B1|Baseline|AZD0837 150 mg|AZD0837 150 mg
1075863|NCT00623779|P3|Participant Flow|Standard Therapy|Standard Therapy
1075864|NCT00623779|P2|Participant Flow|AZD0837 300 mg|AZD0837 300 mg
1075865|NCT00623779|P1|Participant Flow|AZD0837 150 mg|AZD0837 150 mg
1075866|NCT00623779|O3|Outcome|Standard Therapy|Standard Therapy
1075912|NCT00623766|B2|Baseline|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who were dependent on corticosteroid therapy received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
1075913|NCT00623766|B1|Baseline|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
1075914|NCT00623766|P2|Participant Flow|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
1075915|NCT00623766|P1|Participant Flow|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
1075916|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg, IV in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
1075917|NCT00623766|O1|Outcome|Ipilimumab, 10 mg/kg, IV in Corticosteroid-free Patients|"Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV, every 12 weeks, beginning at Week 24.~Ipilimumab: 10 mg/kg, administered as an intravenous infusion every 3 weeks during induction and every 12 weeks during maintenance"
1075918|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who were dependent on corticosteroid therapy received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
1075919|NCT00623766|O1|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
1075920|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who were dependent on corticosteroid therapy received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
1075921|NCT00623766|O1|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
1075960|NCT00623714|P2|Participant Flow|Fluticasone Then Placebo|Days 1-2 500 µg Fluticasone b.i.d. + Day 3 500 µg Fluticasone single dose, Days 1-2 Placebo b.i.d. + Day 3 Placebo single dose
1076264|NCT00622908|E2|Reported Event|Vehicle|Vehicle of ISV-403
1076265|NCT00622908|E1|Reported Event|ISV-403|0.6% ISV-403
1075922|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
1075923|NCT00623766|O1|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
1075969|NCT00623636|B2|Baseline|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
1075924|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
1075925|NCT00623766|O1|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
1075926|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who were dependent on corticosteroid therapy received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
1075927|NCT00623766|O1|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
1075928|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
1075929|NCT00623766|O1|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
1075930|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
1075931|NCT00623766|O1|Outcome|Ipilimumab 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
1075932|NCT00623766|O2|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
1075933|NCT00623766|O1|Outcome|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
1075934|NCT00623766|E2|Reported Event|Ipilimumab, 10 mg/kg IV, in Corticosteroid-free Patients|Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
1075935|NCT00623766|E1|Reported Event|Ipilimumab, 10 mg/kg IV, in Corticosteroid-dependent Patients|Participants who required concurrent systemic corticosteroid therapy for adequate control of neurologic signs and symptoms related to metastatic brain lesion received ipilimumab,10 mg/kg, as a 90-minute IV infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV every 12 weeks, beginning at Week 24.
1075936|NCT00623727|B3|Baseline|Total|Total of all reporting groups
1075937|NCT00623727|B2|Baseline|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
1076068|NCT00623506|O2|Outcome|Placebo|"Placebo~Subjects received placebo study medication; dispensed exactly as active study medication was dispensed."
1075938|NCT00623727|B1|Baseline|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
1075939|NCT00623727|P2|Participant Flow|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
1075940|NCT00623727|P1|Participant Flow|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
1075941|NCT00623727|O2|Outcome|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
1075942|NCT00623727|O1|Outcome|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
1075943|NCT00623727|O2|Outcome|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
1075944|NCT00623727|O1|Outcome|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
1075945|NCT00623727|O2|Outcome|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
1075946|NCT00623727|O1|Outcome|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
1075947|NCT00623727|O2|Outcome|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
1075948|NCT00623727|O1|Outcome|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
1075949|NCT00623727|O2|Outcome|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
1075950|NCT00623727|O1|Outcome|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
1075951|NCT00623727|O2|Outcome|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
1075952|NCT00623727|O1|Outcome|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
1075953|NCT00623727|O2|Outcome|rFVIII-FS/WFI (BAY14-2222)|25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
1075954|NCT00623727|O1|Outcome|rFVIII-FS/Pegylated Liposomes (BAY79-4980)|35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
1075955|NCT00623727|E4|Reported Event|rFVIII-FS/Pegylated Liposomes (BAY79-4980) - Extension|Reporting group 4 (RG4): Open Label Extension, 35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII-FS excipient reconstituted in WFI)
1075956|NCT00623727|E3|Reported Event|rFVIII-FS/WFI (BAY14-2222) - Follow-up|Reporting group 3 (RG3): Open Label Follow-up, 25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
1075957|NCT00623727|E2|Reported Event|rFVIII-FS/WFI (BAY14-2222) - Double Blind|Reporting group 2 (RG2): Double Blind Study, 25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
1075958|NCT00623727|E1|Reported Event|rFVIII-FS/Pegylated Liposomes (BAY79-4980) - Double Blind|Reporting Group 1 (RG1): Double Blind Study, 35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII-FS excipient reconstituted in WFI)
1075959|NCT00623714|B1|Baseline|All Patients|All Randomized Patients
1076151|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1075961|NCT00623714|P1|Participant Flow|Placebo Then Fluticasone|Days 1-2 Placebo twice a Day (b.i.d.) + Day 3 Placebo single dose, Days 1-2 500 µg Fluticasone b.i.d. + Day 3 500 µg Fluticasone single dose
1075962|NCT00623714|O2|Outcome|Fluticasone|Days 1-2 500 µg Fluticasone b.i.d. + Day 3 500 µg Fluticasone single dose
1075963|NCT00623714|O1|Outcome|Placebo|Days 1-2 Placebo b.i.d. + Day 3 Placebo single dose
1075964|NCT00623714|O2|Outcome|Fluticasone|Days 1-2 500 µg Fluticasone b.i.d. + Day 3 500 µg Fluticasone single dose
1075965|NCT00623714|O1|Outcome|Placebo|Days 1-2 Placebo b.i.d. + Day 3 Placebo single dose
1075966|NCT00623714|E2|Reported Event|Fluticasone|Days 1-2 500 µg Fluticasone b.i.d. + Day 3 500 µg Fluticasone single dose
1075967|NCT00623714|E1|Reported Event|Placebo|Days 1-2 Placebo b.i.d. + Day 3 Placebo single dose
1075970|NCT00623636|B1|Baseline|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
1075971|NCT00623636|P2|Participant Flow|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
1075972|NCT00623636|P1|Participant Flow|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
1075973|NCT00623636|O2|Outcome|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
1075974|NCT00623636|O1|Outcome|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
1075975|NCT00623636|O2|Outcome|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
1075976|NCT00623636|O1|Outcome|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
1075977|NCT00623636|O2|Outcome|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
1075978|NCT00623636|O1|Outcome|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
1075979|NCT00623636|O2|Outcome|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
1075980|NCT00623636|O1|Outcome|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
1075981|NCT00623636|O2|Outcome|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
1075982|NCT00623636|O1|Outcome|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
1075983|NCT00623636|O2|Outcome|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
1075984|NCT00623636|O1|Outcome|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
1075985|NCT00623636|O2|Outcome|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
1075986|NCT00623636|O1|Outcome|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
1075987|NCT00623636|O2|Outcome|MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
1075988|NCT00623636|O1|Outcome|Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
1075989|NCT00623636|E3|Reported Event|Open-label MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
1075990|NCT00623636|E2|Reported Event|Double-blind MAP0004|MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
1075991|NCT00623636|E1|Reported Event|Double-blind Placebo|Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat a qualifying migraine for up to an additional 52 weeks.
1075992|NCT00623597|B3|Baseline|Total|Total of all reporting groups
1075993|NCT00623597|B2|Baseline|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1075994|NCT00623597|B1|Baseline|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1075995|NCT00623597|P2|Participant Flow|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076069|NCT00623506|O1|Outcome|Pregnenolone|"Pregnenolone~Pregnenolone : Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID)"
1076070|NCT00623506|O2|Outcome|Placebo|"Placebo~Subjects received placebo study medication; dispensed exactly as active study medication was dispensed."
1076074|NCT00623506|E2|Reported Event|Placebo|"Placebo~Subjects received placebo study medication; dispensed exactly as active study medication was dispensed."
1075996|NCT00623597|P1|Participant Flow|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1075997|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1075998|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1075999|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076000|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076001|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076002|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076003|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076004|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076005|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076006|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076007|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076008|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076009|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076010|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076011|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076012|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076013|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076014|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076015|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076016|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076266|NCT00622869|B4|Baseline|Total|Total of all reporting groups
1076071|NCT00623506|O1|Outcome|Pregnenolone|"Pregnenolone~Pregnenolone : Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID)"
1076072|NCT00623506|O2|Outcome|Placebo|"Placebo~Subjects received placebo study medication; dispensed exactly as active study medication was dispensed."
1076073|NCT00623506|O1|Outcome|Pregnenolone|"Pregnenolone~Pregnenolone : Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID)"
1076017|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076018|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076019|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076020|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076021|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076022|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076023|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076024|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076025|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076026|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076027|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076028|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076029|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076030|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076031|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076032|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076033|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076034|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076035|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076036|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076037|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076038|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076039|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076040|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076041|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076042|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076043|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076044|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076045|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076046|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076047|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076048|NCT00623597|O3|Outcome|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076049|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076050|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076051|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076052|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076053|NCT00623597|O2|Outcome|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076054|NCT00623597|O1|Outcome|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076055|NCT00623597|E3|Reported Event|Total|Participants received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076056|NCT00623597|E2|Reported Event|Group B|Participants (children >= 2 years to <6 years old) received saquinavir at a dose of 50 mg/Kg BID and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076057|NCT00623597|E1|Reported Event|Group A|Participants (infants >= 4 months to <2 years old) received saquinavir at a dose of 50 milligram per kilogram (mg/Kg) twice a day (BID) and ritonavir at a dose of 3 mg/kg BID for body weight from 5 to < 15 kg, 2.5 mg/kg BID for body weight from 15 to 40 kg and 100 mg BID for body weight > 40 kg plus >= 2 background ARVs. After 14 days of treatment (or Day 28 for participants switching from an NNRTI containing regimen), saquinavir and ritonavir dose adjustments were made within the age group or for individual participants as deemed appropriate. The highest dose for saquinavir/ritonavir that was to be administered was not to exceed 1000 mg/100 mg BID. Participants received treatment for 48 weeks.
1076058|NCT00623545|B1|Baseline|Single Arm Study of Exenatide Treatment|Subjects serve as their own controls. Measures of outcomes are performed before and at the end of treatment. Outcomes are based on the change in the variables.
1076059|NCT00623545|P1|Participant Flow|Single Arm Study of Exenatide Treatment|Subjects serve as their own controls. Measures of outcome variables are made before treatment and again at the end of the1 treatment period made. Outcomes are based on the change in these variables.
1076060|NCT00623545|O1|Outcome|Exenitide Treatment|
1076061|NCT00623545|O1|Outcome|Exenitide Treatment|There is one treatment arm. Subjects serve as their own controls for the outcome measure. The measures are made before the treatment is started at during the end of the treatment.
1076062|NCT00623545|E1|Reported Event|Single Arm Study of Exenatide Treatment|
1076063|NCT00623506|B3|Baseline|Total|Total of all reporting groups
1076064|NCT00623506|B2|Baseline|Placebo|"Placebo~Subjects received placebo study medication; dispensed exactly as active study medication was dispensed."
1076065|NCT00623506|B1|Baseline|Pregnenolone|"Pregnenolone~Pregnenolone : Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID)"
1076066|NCT00623506|P2|Participant Flow|Placebo|"Placebo~Subjects received placebo study medication; dispensed exactly as active study medication was dispensed."
1076067|NCT00623506|P1|Participant Flow|Pregnenolone|"Pregnenolone~Pregnenolone : Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID)"
1076267|NCT00622869|B3|Baseline|Tacrolimus Control Arm|Control dose tacrolimus + corticosteroids.
1076075|NCT00623506|E1|Reported Event|Pregnenolone|"Pregnenolone~Pregnenolone : Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID)"
1076076|NCT00623480|B3|Baseline|Total|Total of all reporting groups
1076077|NCT00623480|B2|Baseline|Recombinant Factor VIII On-demand Treatment|Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
1076078|NCT00623480|B1|Baseline|Recombinant Factor VIII Prophylaxis Treatment|Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
1076079|NCT00623480|P2|Participant Flow|Recombinant Factor VIII On-demand Treatment|Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
1076080|NCT00623480|P1|Participant Flow|Recombinant Factor VIII Prophylaxis Treatment|Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
1076081|NCT00623480|O2|Outcome|Recombinant Factor VIII On-demand Treatment|Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
1076082|NCT00623480|O1|Outcome|Recombinant Factor VIII Prophylaxis Treatment|Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
1076083|NCT00623480|O2|Outcome|Recombinant Factor VIII On-demand Treatment|Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
1076084|NCT00623480|O1|Outcome|Recombinant Factor VIII Prophylaxis Treatment|Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
1076085|NCT00623480|O2|Outcome|Recombinant Factor VIII On-demand Treatment|Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
1076086|NCT00623480|O1|Outcome|Recombinant Factor VIII Prophylaxis Treatment|Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
1076087|NCT00623480|O2|Outcome|Recombinant Factor VIII On-demand Treatment|Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
1076088|NCT00623480|O1|Outcome|Recombinant Factor VIII Prophylaxis Treatment|Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
1076089|NCT00623480|E2|Reported Event|Recombinant Factor VIII On-demand Treatment|Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
1076090|NCT00623480|E1|Reported Event|Recombinant Factor VIII Prophylaxis Treatment|Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
1076091|NCT00623467|B1|Baseline|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076092|NCT00623467|P1|Participant Flow|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076093|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076094|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1076329|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
1076095|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076096|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1076097|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076098|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1076099|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076100|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1076101|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076102|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1076103|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076104|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1076105|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076106|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1076107|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076108|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1076109|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076110|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1076111|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076112|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1076113|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076114|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1076115|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076116|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1076117|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076118|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1076119|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076120|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1076121|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076122|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1076215|NCT00623181|O1|Outcome|Fluzone Intradermal Vaccine|Responses of participants following the receipt of a dose of Fluzone Intradermal (ID) in the right deltoid region or the left deltoid region on Day 0
1076123|NCT00623467|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076124|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076125|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1076126|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076127|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1076128|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076129|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1076130|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076131|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1076132|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076133|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1076134|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076135|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1076136|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076137|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1076138|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076139|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1076140|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076141|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1076142|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076143|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1076144|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076145|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1076146|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076147|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1076148|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076149|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1076150|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076152|NCT00623467|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076153|NCT00623467|O1|Outcome|Unenhanced|Participants had diagnostic imaging before receiving any contrast agent
1076154|NCT00623467|E1|Reported Event|Gadobutrol (Gadavist, BAY86-4875)|Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.
1076155|NCT00623441|B1|Baseline|Endeavor Coronary Stent|Patients with an indication for a percutaneous coronary intervention with implantation with a drug eluting stent
1076156|NCT00623441|P1|Participant Flow|Endeavor Coronary Stent|Patients with an indication for a percutaneous coronary intervention with implantation with a drug eluting stent
1076157|NCT00623441|O1|Outcome|Endeavor Coronary Stent|Patients with an indication for a percutaneous coronary intervention with implantation with a drug eluting stent
1076158|NCT00623441|E1|Reported Event|Endeavor Coronary Stent|Patients with an indication for a percutaneous coronary intervention with implantation with a drug eluting stent
1076159|NCT00623428|B3|Baseline|Total|Total of all reporting groups
1076160|NCT00623428|B2|Baseline|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
1076161|NCT00623428|B1|Baseline|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
1076162|NCT00623428|P2|Participant Flow|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
1076163|NCT00623428|P1|Participant Flow|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with pegylated-interferon (peginterferon) alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
1076164|NCT00623428|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
1076165|NCT00623428|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
1076166|NCT00623428|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
1076167|NCT00623428|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
1076168|NCT00623428|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
1076182|NCT00623233|O1|Outcome|Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg|"Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.~Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
1076169|NCT00623428|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
1076170|NCT00623428|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
1076221|NCT00623181|E1|Reported Event|Fluzone Intradermal First, Then Fluzone Intramuscular|Participants who received 1 dose of Fluzone Intradermal (ID) in the right deltoid region, followed by Fluzone Intramuscular (IM) in the left deltoid region on Day 0
1076171|NCT00623428|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
1076172|NCT00623428|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
1076173|NCT00623428|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
1076174|NCT00623428|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
1076175|NCT00623428|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
1076176|NCT00623428|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
1076177|NCT00623428|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
1076178|NCT00623428|E2|Reported Event|PEG-IFN Alfa-2a + Ribavirin for 48 Weeks|After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
1076179|NCT00623428|E1|Reported Event|PEG-IFN Alfa-2a + Ribavirin for 24 Weeks|After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
1076180|NCT00623233|B1|Baseline|Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg|"Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.~Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
1076181|NCT00623233|P1|Participant Flow|Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg|"Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.~Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
1076261|NCT00622908|O1|Outcome|ISV-403|0.6% ISV-403
1076262|NCT00622908|O2|Outcome|Vehicle|Vehicle of ISV-403
1076183|NCT00623233|O1|Outcome|Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg|"Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.~Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
1076184|NCT00623233|O1|Outcome|Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg|"Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.~Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
1076185|NCT00623233|O1|Outcome|Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg|"Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.~Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
1076186|NCT00623233|E1|Reported Event|Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg|"Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.~Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity."
1076187|NCT00623194|B1|Baseline|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
1076188|NCT00623194|P1|Participant Flow|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
1076189|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
1076190|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
1076191|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
1076192|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
1076193|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
1076194|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
1076195|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
1076196|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
1076197|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
1076198|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
1076199|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
1076200|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
1076201|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
1076202|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
1076203|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
1076204|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
1076205|NCT00623194|O1|Outcome|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
1076206|NCT00623194|E1|Reported Event|Insulin Detemir|Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
1076207|NCT00623181|B3|Baseline|Total|Total of all reporting groups
1076208|NCT00623181|B2|Baseline|Fluzone Intramuscular First, Then Fluzone Intradermal|Participants who received 1 dose of Fluzone Intramuscular in the right deltoid region, followed by Fluzone Intradermal (ID) in the left deltoid region on Day 0
1076209|NCT00623181|B1|Baseline|Fluzone Intradermal First, Then Fluzone Intramuscular|Participants who received 1 dose of Fluzone Intradermal (ID) in the right deltoid region, followed by Fluzone Intramuscular (IM) in the left deltoid region on Day 0
1076210|NCT00623181|P2|Participant Flow|Fluzone Intramuscular First, Then Fluzone Intradermal|Participants who received 1 dose of Fluzone Intramuscular in the right deltoid region, followed by Fluzone Intradermal (ID) in the left deltoid region on Day 0
1076211|NCT00623181|P1|Participant Flow|Fluzone Intradermal First, Then Fluzone Intramuscular|Participants who received 1 dose of Fluzone Intradermal (ID) in the right deltoid region, followed by Fluzone Intramuscular (IM) in the left deltoid region on Day 0
1076212|NCT00623181|O2|Outcome|Fluzone Intramuscular First, Then Fluzone Intradermal|Participants who received 1 dose of Fluzone Intramuscular in the right deltoid region, followed by Fluzone Intradermal (ID) in the left deltoid region on Day 0
1076213|NCT00623181|O1|Outcome|Fluzone Intradermal First, Then Fluzone Intramuscular|Participants who received 1 dose of Fluzone Intradermal (ID) in the right deltoid region, followed by Fluzone Intramuscular (IM) in the left deltoid region on Day 0
1076214|NCT00623181|O2|Outcome|Fluzone Intramuscular Vaccine|Responses of participants following the receipt of a dose of Fluzone Intramuscular (IM) in the right deltoid region or the left deltoid region on Day 0.
1076263|NCT00622908|O1|Outcome|ISV-403|0.6% ISV-403
1076216|NCT00623181|O2|Outcome|Fluzone Intramuscular Vaccine|Responses of participants following the receipt of a dose of Fluzone Intramuscular (IM) in the right deltoid region or the left deltoid region on Day 0
1076217|NCT00623181|O1|Outcome|Fluzone Intradermal Vaccine|Responses of participants following the receipt of a dose of Fluzone Intradermal (ID) in the right deltoid region or the left deltoid region on Day 0.
1076218|NCT00623181|O2|Outcome|Fluzone Intramuscular Vaccine|Responses of participants following the receipt of a dose of Fluzone Intramuscular (IM) in the right deltoid region or the left deltoid region on Day 0
1076219|NCT00623181|O1|Outcome|Fluzone Intradermal Vaccine|Responses of participants following the receipt of a dose of Fluzone Intradermal (ID) in the right deltoid region or the left deltoid region on Day 0
1076220|NCT00623181|E2|Reported Event|Fluzone Intramuscular First, Then Fluzone Intradermal|Participants who received 1 dose of Fluzone Intramuscular in the right deltoid region, followed by Fluzone Intradermal (ID) in the left deltoid region on Day 0
1076222|NCT00623103|B3|Baseline|Total|Total of all reporting groups
1076223|NCT00623103|B2|Baseline|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
1076224|NCT00623103|B1|Baseline|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
1076225|NCT00623103|P2|Participant Flow|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
1076226|NCT00623103|P1|Participant Flow|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
1076227|NCT00623103|O2|Outcome|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
1076228|NCT00623103|O1|Outcome|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
1076229|NCT00623103|O2|Outcome|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
1076230|NCT00623103|O1|Outcome|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
1076231|NCT00623103|O2|Outcome|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
1076232|NCT00623103|O1|Outcome|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
1076233|NCT00623103|O2|Outcome|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
1076234|NCT00623103|O1|Outcome|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
1076235|NCT00623103|O2|Outcome|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
1076236|NCT00623103|O1|Outcome|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
1076237|NCT00623103|O2|Outcome|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
1076238|NCT00623103|O1|Outcome|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
1076239|NCT00623103|O2|Outcome|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
1076240|NCT00623103|O1|Outcome|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
1076241|NCT00623103|O2|Outcome|Rivastigmine Patch|Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.
1076242|NCT00623103|O1|Outcome|Rivastigmine Capsule|Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
1076243|NCT00623103|E2|Reported Event|Exelon Patch|Exelon Patch
1076244|NCT00623103|E1|Reported Event|Exelon Capsule|Exelon Capsule
1076276|NCT00622869|O3|Outcome|Tacrolimus Control Arm|Control dose tacrolimus + corticosteroids.
1076277|NCT00622869|O2|Outcome|Tacrolimus Elimination|Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.
1076245|NCT00623012|B1|Baseline|Rapamycin Study Arm|"Rapamycin: Rapamycin will be initiated 24 weeks post SCT, while the patient is on Tacrolimus. The initial dose of rapamycin is 12 mg of loading dose, followed by 4 mg daily. The dose will be adjusted to keep trough level at 3-12 ng/dl. Rapamycin will be continued at the therapeutic dose for 4 additional weeks after Tacrolimus is stopped. Rapamycin will then be tapered off over 2 weeks. The patients will be on 50% of steady state dose for one week and 25% of the steady state dose for the last week.~Tacrolimus: Tacrolimus target level is 5-10 ng/dl. Tacrolimus taper will start at 26 weeks post SCT. Tacrolimus will be tapered off over 4-8 weeks. The rate of taper will be 25% every to weeks for patients on 4 mg or more tacrolimus daily. For the patients on 3 mg or less of tacrolimus, the dose will be reduced 1 mg every two weeks, and the last dose will be 1 mg every other day for two weeks."
1076246|NCT00623012|P1|Participant Flow|Study Population|"This is a single arm study:~Rapamycin: Rapamycin will be initiated 24 weeks post SCT, while the patient is on Tacrolimus. The initial dose of rapamycin is 12 mg of loading dose, followed by 4 mg daily. The dose will be adjusted to keep trough level at 3-12 ng/dl. Rapamycin will be continued at the therapeutic dose for 4 additional weeks after Tacrolimus is stopped. Rapamycin will then be tapered off over 2 weeks. The patients will be on 50% of steady state dose for one week and 25% of the steady state dose for the last week.~Tacrolimus: Tacrolimus target level is 5-10 ng/dl. Tacrolimus taper will start at 26 weeks post SCT. Tacrolimus will be tapered off over 4-8 weeks. The rate of taper will be 25% every to weeks for patients on 4 mg or more tacrolimus daily. For the patients on 3 mg or less of tacrolimus, the dose will be reduced 1 mg every two weeks, and the last dose will be 1 mg every other day for two weeks."
1076247|NCT00623012|O1|Outcome|Study Population|"This is a single arm study:~Rapamycin: Rapamycin will be initiated 24 weeks post SCT, while the patient is on Tacrolimus. The initial dose of rapamycin is 12 mg of loading dose, followed by 4 mg daily. The dose will be adjusted to keep trough level at 3-12 ng/dl. Rapamycin will be continued at the therapeutic dose for 4 additional weeks after Tacrolimus is stopped. Rapamycin will then be tapered off over 2 weeks. The patients will be on 50% of steady state dose for one week and 25% of the steady state dose for the last week.~Tacrolimus: Tacrolimus target level is 5-10 ng/dl. Tacrolimus taper will start at 26 weeks post SCT. Tacrolimus will be tapered off over 4-8 weeks. The rate of taper will be 25% every to weeks for patients on 4 mg or more tacrolimus daily. For the patients on 3 mg or less of tacrolimus, the dose will be reduced 1 mg every two weeks, and the last dose will be 1 mg every other day for two weeks."
1076248|NCT00623012|O1|Outcome|Study Population|"This is a single arm study:~Rapamycin: Rapamycin will be initiated 24 weeks post SCT, while the patient is on Tacrolimus. The initial dose of rapamycin is 12 mg of loading dose, followed by 4 mg daily. The dose will be adjusted to keep trough level at 3-12 ng/dl. Rapamycin will be continued at the therapeutic dose for 4 additional weeks after Tacrolimus is stopped. Rapamycin will then be tapered off over 2 weeks. The patients will be on 50% of steady state dose for one week and 25% of the steady state dose for the last week.~Tacrolimus: Tacrolimus target level is 5-10 ng/dl. Tacrolimus taper will start at 26 weeks post SCT. Tacrolimus will be tapered off over 4-8 weeks. The rate of taper will be 25% every to weeks for patients on 4 mg or more tacrolimus daily. For the patients on 3 mg or less of tacrolimus, the dose will be reduced 1 mg every two weeks, and the last dose will be 1 mg every other day for two weeks."
1076249|NCT00623012|O1|Outcome|Study Population|"This is a single arm study:~Rapamycin: Rapamycin will be initiated 24 weeks post SCT, while the patient is on Tacrolimus. The initial dose of rapamycin is 12 mg of loading dose, followed by 4 mg daily. The dose will be adjusted to keep trough level at 3-12 ng/dl. Rapamycin will be continued at the therapeutic dose for 4 additional weeks after Tacrolimus is stopped. Rapamycin will then be tapered off over 2 weeks. The patients will be on 50% of steady state dose for one week and 25% of the steady state dose for the last week.~Tacrolimus: Tacrolimus target level is 5-10 ng/dl. Tacrolimus taper will start at 26 weeks post SCT. Tacrolimus will be tapered off over 4-8 weeks. The rate of taper will be 25% every to weeks for patients on 4 mg or more tacrolimus daily. For the patients on 3 mg or less of tacrolimus, the dose will be reduced 1 mg every two weeks, and the last dose will be 1 mg every other day for two weeks."
1076250|NCT00623012|E1|Reported Event|Study Arm|"Rapamycin: Rapamycin will be initiated 24 weeks post SCT, while the patient is on Tacrolimus. The initial dose of rapamycin is 12 mg of loading dose, followed by 4 mg daily. The dose will be adjusted to keep trough level at 3-12 ng/dl. Rapamycin will be continued at the therapeutic dose for 4 additional weeks after Tacrolimus is stopped. Rapamycin will then be tapered off over 2 weeks. The patients will be on 50% of steady state dose for one week and 25% of the steady state dose for the last week.~Tacrolimus: Tacrolimus target level is 5-10 ng/dl. Tacrolimus taper will start at 26 weeks post SCT. Tacrolimus will be tapered off over 4-8 weeks. The rate of taper will be 25% every to weeks for patients on 4 mg or more tacrolimus daily. For the patients on 3 mg or less of tacrolimus, the dose will be reduced 1 mg every two weeks, and the last dose will be 1 mg every other day for two weeks."
1076251|NCT00622908|B3|Baseline|Total|Total of all reporting groups
1076252|NCT00622908|B2|Baseline|Vehicle|Vehicle of ISV-403
1076253|NCT00622908|B1|Baseline|ISV-403|0.6% ISV-403
1076254|NCT00622908|P2|Participant Flow|Vehicle|Vehicle of ISV-403
1076255|NCT00622908|P1|Participant Flow|ISV-403|0.6% ISV-403
1076256|NCT00622908|O2|Outcome|Vehicle|Vehicle of ISV-403
1076257|NCT00622908|O1|Outcome|ISV-403|0.6% ISV-403
1076258|NCT00622908|O2|Outcome|Vehicle|Vehicle of ISV-403
1076259|NCT00622908|O1|Outcome|ISV-403|0.6% ISV-403
1076260|NCT00622908|O2|Outcome|Vehicle|Vehicle of ISV-403
1076268|NCT00622869|B2|Baseline|Tacrolimus Elimination|Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.
1076269|NCT00622869|B1|Baseline|Everolimus + Reduced Tacrolimus|Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.
1076270|NCT00622869|P3|Participant Flow|Tacrolimus Control Arm|Control dose tacrolimus + corticosteroids.
1076271|NCT00622869|P2|Participant Flow|Tacrolimus Elimination|Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.
1076272|NCT00622869|P1|Participant Flow|Everolimus + Reduced Tacrolimus|Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.
1076273|NCT00622869|O3|Outcome|Tacrolimus Control Arm|Control dose tacrolimus + corticosteroids.
1076274|NCT00622869|O2|Outcome|Tacrolimus Elimination|Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.
1076275|NCT00622869|O1|Outcome|Everolimus + Reduced Tacrolimus|Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.
1076278|NCT00622869|O1|Outcome|Everolimus + Reduced Tacrolimus|Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.
1076279|NCT00622869|O3|Outcome|Tacrolimus Control Arm|Control dose tacrolimus + corticosteroids.
1076280|NCT00622869|O2|Outcome|Tacrolimus Elimination|Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.
1076281|NCT00622869|O1|Outcome|Everolimus + Reduced Tacrolimus|Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.
1076282|NCT00622869|O3|Outcome|Tacrolimus Control Arm|Control dose tacrolimus + corticosteroids.
1076283|NCT00622869|O2|Outcome|Tacrolimus Elimination|Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.
1076284|NCT00622869|O1|Outcome|Everolimus + Reduced Tacrolimus|Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.
1076285|NCT00622869|E3|Reported Event|Tacrolimus Control Arm|Control dose tacrolimus + corticosteroids
1076286|NCT00622869|E2|Reported Event|Tacrolimus Elimination|Low dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids
1076287|NCT00622869|E1|Reported Event|Everolimus + Reduced Tacrolimus|Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids
1076288|NCT00622739|B3|Baseline|Total|Total of all reporting groups
1076289|NCT00622739|B2|Baseline|Ziprasidone Slow Dose Group|"Slow Dose Titration Group~Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
1076290|NCT00622739|B1|Baseline|Ziprasidone Rapid Dose Group|"Rapid Dose Titration Group~Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
1076291|NCT00622739|P2|Participant Flow|Ziprasidone Slow Dose Group|"Slow Dose Titration Group~Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
1076292|NCT00622739|P1|Participant Flow|Ziprasidone Rapid Dose Group|"Rapid Dose Titration Group~Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
1076293|NCT00622739|O2|Outcome|Ziprasidone Slow Dose Group|"Slow Dose Titration Group~Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
1076294|NCT00622739|O1|Outcome|Ziprasidone Rapid Dose Group|"Rapid Dose Titration Group~Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
1076295|NCT00622739|E2|Reported Event|Ziprasidone Slow Dose Group|"Slow Dose Titration Group~Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
1076296|NCT00622739|E1|Reported Event|Ziprasidone Rapid Dose Group|"Rapid Dose Titration Group~Ziprasidone: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects."
1076297|NCT00622726|B3|Baseline|Total|Total of all reporting groups
1076298|NCT00622726|B2|Baseline|Conventional Laser for ROP-Control Arm|Conventional Laser to the Peripheral Retina is the Control Arm of this Study. 33 patients had zone I ROP; 40 patients had posterior zone II ROP.
1076299|NCT00622726|B1|Baseline|Bevacizumab for ROP-Experimental Arm|Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study. 31 patients had zone I ROP; 39 patients had zone II posterior ROP.
1076300|NCT00622726|P2|Participant Flow|Conventional Laser for ROP-Control Arm|Conventional Laser to the Peripheral Retina is the Control Arm of this Study. 33 patients had zone I ROP; 40 patients had posterior zone II ROP.
1076330|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
1076301|NCT00622726|P1|Participant Flow|Bevacizumab for ROP-Experimental Arm|Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study. 31 patients had zone I ROP; 39 patients had zone II posterior ROP.
1076302|NCT00622726|O4|Outcome|Conventional Laser-Control Group: Posterior Zone II|The eyes of all surviving infants without recurrences and without any previous intra-ocular surgery who received conventional laser will be examined: Posterior Zone II.
1076303|NCT00622726|O3|Outcome|Bevacizumab Experimental Group: Posterior Zone II|The eyes of all surviving infants without recurrences and without any previous intra-ocular surgery who received bevacizumab will be examined: Posterior Zone II.
1076304|NCT00622726|O2|Outcome|Conventional Laser-Control Group: Zone I|The eyes of all surviving infants without recurrences and without any previous intra-ocular surgery who received conventional laser will be examined: Zone I.
1076305|NCT00622726|O1|Outcome|Bevacizumab-Experimental Group: Zone I|The eyes of all surviving infants without recurrences and without any previous intra-ocular surgery who received bevacizumab will be examined: Zone I.
1076306|NCT00622726|O2|Outcome|Conventional Laser for ROP-Control Arm|Conventional Laser to the Peripheral Retina is the Control Arm of this Study. 33 patients/66 eyes had zone I ROP; 40 patients/80 eyes had posterior zone II ROP.
1076307|NCT00622726|O1|Outcome|Bevacizumab for ROP-Experimental Arm|Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study. 31 patients/62 eyes had zone I ROP; 39 patients/78 eyes had zone II posterior ROP.
1076308|NCT00622726|E2|Reported Event|Conventional Laser for ROP-Control Arm|Conventional Laser to the Peripheral Retina is the Control Arm of this Study. 33 patients had zone I ROP; 40 patients had posterior zone II ROP.
1076309|NCT00622726|E1|Reported Event|Bevacizumab for ROP-Experimental Arm|Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study. 31 patients had zone I ROP; 39 patients had zone II posterior ROP.
1076310|NCT00622713|B1|Baseline|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
1076311|NCT00622713|P1|Participant Flow|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
1076312|NCT00622713|O1|Outcome|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
1076313|NCT00622713|O1|Outcome|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
1076314|NCT00622713|O1|Outcome|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
1076315|NCT00622713|O1|Outcome|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
1076316|NCT00622713|O1|Outcome|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
1076317|NCT00622713|E1|Reported Event|Rivastigmine Transdermal Patch|During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2.
1076318|NCT00622700|B4|Baseline|Total|Total of all reporting groups
1076319|NCT00622700|B3|Baseline|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
1076320|NCT00622700|B2|Baseline|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
1076321|NCT00622700|B1|Baseline|Placebo|Placebo matched to teriflunomide tablet once daily orally.
1076322|NCT00622700|P7|Participant Flow|Teriflunomide 14 mg/14 mg|"Core treatment period: Teriflunomide 14 mg tablet once daily orally.~Extension treatment period: Teriflunomide 14 mg tablet once daily orally."
1076323|NCT00622700|P6|Participant Flow|Placebo/Teriflunomide 14 mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.~Extension treatment period: Teriflunomide 14 mg tablet once daily orally."
1076324|NCT00622700|P5|Participant Flow|Teriflunomide 7 mg/7 mg|"Core treatment period: Teriflunomide 7 mg tablet once daily orally.~Extension treatment period: Teriflunomide 7 mg tablet once daily orally."
1076325|NCT00622700|P4|Participant Flow|Placebo/ Teriflunomide 7 mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.~Extension treatment period: Teriflunomide 7 mg tablet once daily orally."
1076326|NCT00622700|P3|Participant Flow|Teriflunomide 14 mg|Core treatment period: Teriflunomide 14 mg tablet once daily orally.
1076327|NCT00622700|P2|Participant Flow|Teriflunomide 7 mg|Core treatment period: Teriflunomide 7 mg tablet once daily orally.
1076328|NCT00622700|P1|Participant Flow|Placebo|Core treatment period: Placebo matched to teriflunomide tablet once daily orally.
1076331|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
1076332|NCT00622700|O4|Outcome|Teriflunomide 14 mg/14 mg|"Core treatment period: Teriflunomide 14 mg tablet once daily orally.~Extension treatment period: Teriflunomide 14 mg tablet once daily orally."
1076333|NCT00622700|O3|Outcome|Placebo/ Teriflunomide 14 mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.~Extension treatment period: Teriflunomide 14 mg tablet once daily orally."
1076334|NCT00622700|O2|Outcome|Teriflunomide 7 mg/ 7mg|"Core treatment period: Teriflunomide 7 mg tablet once daily orally.~Extension treatment period: Teriflunomide 7 mg tablet once daily orally."
1076335|NCT00622700|O1|Outcome|Placebo/Teriflunomide 7 mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.~Extension treatment period: Teriflunomide 7 mg tablet once daily orally."
1076336|NCT00622700|O4|Outcome|Teriflunomide 14 mg/14 mg|"Core treatment period: Teriflunomide 14 mg tablet once daily orally.~Extension treatment period: Teriflunomide 14 mg tablet once daily orally."
1076337|NCT00622700|O3|Outcome|Placebo/ Teriflunomide 14 mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.~Extension treatment period: Teriflunomide 14 mg tablet once daily orally."
1076338|NCT00622700|O2|Outcome|Teriflunomide 7 mg/ 7mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.~Extension treatment period: Teriflunomide 7 mg tablet once daily orally."
1076339|NCT00622700|O1|Outcome|Placebo/Teriflunomide 7 mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.~Extension treatment period: Teriflunomide 7 mg tablet once daily orally."
1076340|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
1076341|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
1076342|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
1076343|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
1076344|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
1076345|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
1076346|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
1076347|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
1076348|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
1076349|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
1076350|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
1076351|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
1076352|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
1076353|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
1076354|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
1076355|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
1076356|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
1076357|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
1076358|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
1076359|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
1076360|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
1076361|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
1076362|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
1076363|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
1076364|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
1076365|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
1076366|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
1076367|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
1076368|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
1076369|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
1076370|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
1076371|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
1076372|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
1076373|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
1076374|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
1076375|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
1076376|NCT00622700|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg tablet once daily orally.
1076377|NCT00622700|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg tablet once daily orally.
1076378|NCT00622700|O1|Outcome|Placebo|Placebo matched to teriflunomide tablet once daily orally.
1076379|NCT00622700|E7|Reported Event|Teriflunomide 14 mg/14 mg|"Core treatment period: Teriflunomide 14 mg tablet once daily orally.~Extension treatment period: Teriflunomide 14 mg tablet once daily orally."
1076380|NCT00622700|E6|Reported Event|Placebo/Teriflunomide 14 mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.~Extension treatment period: Teriflunomide 14 mg tablet once daily orally."
1076381|NCT00622700|E5|Reported Event|Teriflunomide 7 mg/7 mg|"Core treatment period: Teriflunomide 7 mg tablet once daily orally.~Extension treatment period: Teriflunomide 7 mg tablet once daily orally."
1076382|NCT00622700|E4|Reported Event|Placebo/Teriflunomide 7 mg|"Core treatment period: Placebo matched to teriflunomide tablet once daily orally.~Extension treatment period: Teriflunomide 7 mg tablet once daily orally."
1076383|NCT00622700|E3|Reported Event|Teriflunomide 14 mg|Core treatment period: Teriflunomide 14 mg tablet once daily orally.
1076384|NCT00622700|E2|Reported Event|Teriflunomide 7 mg|Core treatment period: Teriflunomide 7 mg tablet once daily orally.
1076385|NCT00622700|E1|Reported Event|Placebo|Core treatment period: Placebo matched to teriflunomide tablet once daily orally.
1076386|NCT00622635|B1|Baseline|Entire Study Population|The entire study population included all 6 treatment groups who received indacaterol 300 µg once daily, placebo to indacaterol once daily, and salmeterol 50 µg twice daily via a single-dose (indacaterol and placebo to indacaterol) or multi-dose (salmeterol) dry-powder inhaler in 6 different sequences. Patients received each treatment for 14 days with a 14 day washout between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076400|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076473|NCT00622440|O1|Outcome|AIJP|AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
1076387|NCT00622635|P6|Participant Flow|Salmeterol 50 μg - Placebo to Indacaterol - Indacaterol 300 μg|In treatment period 1, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); in treatment period 2, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); and in treatment period 3, patients received indacaterol 300 μg once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076388|NCT00622635|P5|Participant Flow|Indacaterol 300 μg - Salmeterol 50 μg - Placebo to Indacaterol|In treatment period 1, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); and in treatment period 3, patients received placebo to indacaterol once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076389|NCT00622635|P4|Participant Flow|Placebo to Indacaterol - Indacaterol 300 μg - Salmeterol 50 μg|In treatment period 1, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received indacaterol 300 μg once daily for 14 days via SDDPI; and in treatment period 3, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI). There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076390|NCT00622635|P3|Participant Flow|Salmeterol 50 μg - Indacaterol 300 μg - Placebo to Indacaterol|In treatment period 1, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); in treatment period 2, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); and in treatment period 3, patients received placebo to indacaterol once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076391|NCT00622635|P2|Participant Flow|Placebo to Indacaterol - Salmeterol 50 μg - Indacaterol 300 μg|In treatment period 1, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); and in treatment period 3, patients received indacaterol 300 μg once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076392|NCT00622635|P1|Participant Flow|Indacaterol 300 μg - Placebo to Indacaterol - Salmeterol 50 μg|In treatment period 1, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received placebo to indacaterol once daily for 14 days via SDDPI; and in treatment period 3, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI). There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076393|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076394|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076395|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076396|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076397|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076398|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076399|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076472|NCT00622440|O2|Outcome|Placebo|Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
1076401|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076402|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076403|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076404|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076405|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076406|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076407|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076408|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076409|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076410|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076411|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076412|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076413|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076414|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076415|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076416|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076417|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076462|NCT00622518|O1|Outcome|Ear Drops Plus Standard Therapy|homeopathic ear drops in addition to standard care for otitis media
1076464|NCT00622518|O1|Outcome|Ear Drops Plus Standard Therapy|homeopathic ear drops in addition to standard care for otitis media
1076418|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076419|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076420|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076421|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076422|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076423|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076424|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076425|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076426|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076427|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076428|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076429|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076430|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076431|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076432|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076433|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076434|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076435|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076436|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076437|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076463|NCT00622518|O2|Outcome|Standard Therapy Alone|No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen
1076779|NCT00621582|B1|Baseline|Tiotropium Bromide|
1076438|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076439|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076440|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076441|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076442|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076443|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076444|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076445|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076446|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076447|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076448|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076449|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076450|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076451|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076452|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076453|NCT00622635|E3|Reported Event|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076454|NCT00622635|E2|Reported Event|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076455|NCT00622635|E1|Reported Event|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1076456|NCT00622518|B3|Baseline|Total|Total of all reporting groups
1076457|NCT00622518|B2|Baseline|Standard Therapy Alone|No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen
1076458|NCT00622518|B1|Baseline|Ear Drops Plus Standard Therapy|homeopathic ear drops in addition to standard care for otitis media
1076459|NCT00622518|P2|Participant Flow|Standard Therapy Alone|No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen
1076460|NCT00622518|P1|Participant Flow|Ear Drops Plus Standard Therapy|homeopathic ear drops in addition to standard care for otitis media
1076461|NCT00622518|O2|Outcome|Standard Therapy Alone|No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen
1076465|NCT00622518|E2|Reported Event|Standard Therapy Alone|No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen
1076466|NCT00622518|E1|Reported Event|Ear Drops Plus Standard Therapy|homeopathic ear drops in addition to standard care for otitis media
1076467|NCT00622440|B3|Baseline|Total|Total of all reporting groups
1076468|NCT00622440|B2|Baseline|Placebo|Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
1076469|NCT00622440|B1|Baseline|AIJP|AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
1076470|NCT00622440|P2|Participant Flow|Placebo|Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
1076471|NCT00622440|P1|Participant Flow|AIJP|AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
1076474|NCT00622440|O2|Outcome|Placebo|Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
1076475|NCT00622440|O1|Outcome|AIJP|AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
1076476|NCT00622440|O2|Outcome|Placebo|Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
1076477|NCT00622440|O1|Outcome|AIJP|AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
1076478|NCT00622440|O2|Outcome|Placebo|Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
1076479|NCT00622440|O1|Outcome|AIJP|AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
1076480|NCT00622440|E2|Reported Event|Placebo|Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
1076481|NCT00622440|E1|Reported Event|AIJP|AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
1076482|NCT00622427|B3|Baseline|Total|Total of all reporting groups
1076483|NCT00622427|B2|Baseline|Placebo Then Ramelteon (8 mg)|QD for 14 days prior to sleep first, 2 week wash out period, then Ramelteon QD for 14 days prior to sleep
1076484|NCT00622427|B1|Baseline|Ramelteon Then Placebo (8 mg)|QD for 14 days prior to sleep first, 2 week wash out period, then placebo QD for 14 days prior to sleep
1076485|NCT00622427|P2|Participant Flow|Placebo Then Ramelteon (8 mg)|QD for 14 days prior to sleep first, 2 week wash out period, then Ramelteon QD for 14 days prior to sleep
1076486|NCT00622427|P1|Participant Flow|Ramelteon Then Placebo (8 mg)|QD for 14 days prior to sleep first, 2 week wash out period, then placebo QD for 14 days prior to sleep
1076487|NCT00622427|O2|Outcome|Placebo|QD for 14 days prior to sleep
1076488|NCT00622427|O1|Outcome|Ramelteon|QD for 14 days prior to sleep
1076489|NCT00622427|O2|Outcome|Placebo|QD for 14 days prior to sleep first
1076490|NCT00622427|O1|Outcome|Ramelteon|QD for 14 days prior to sleep first
1076491|NCT00622427|E2|Reported Event|Placebo Then Ramelteon (8 mg)|QD for 14 days prior to sleep first, 2 week wash out period, then Ramelteon QD for 14 days prior to sleep
1076492|NCT00622427|E1|Reported Event|Ramelteon Then Placebo (8 mg)|QD for 14 days prior to sleep first, 2 week wash out period, then placebo QD for 14 days prior to sleep
1076493|NCT00622401|B4|Baseline|Total|Total of all reporting groups
1076494|NCT00622401|B3|Baseline|Group 3: Dendritic Cell/Tumor Fusion Vaccine and Higher Dose I|"Dendritic Cell/tumor fusion vaccine and higher dose IL-12~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells~Interleukin-12: Given subcutaneously at dose of 100ng/kg"
1076495|NCT00622401|B2|Baseline|Group 2: Dendritic Cell/Tumor Fusion Vaccine and Low Dose IL-1|"Dendritic Cell/tumor fusion vaccine and low dose IL-12~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells~Interleukin-12: Given subcutaneously at dose of 30ng/kg"
1076496|NCT00622401|B1|Baseline|Group 1: Dendritic Cell/Tumor Fusion Vaccine Only|"Dendritic Cell/Tumor Fusion Vaccine Only~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells"
1076497|NCT00622401|P3|Participant Flow|Group 3: Dendritic Cell/Tumor Fusion Vaccine and Higher Dose I|"Dendritic Cell/tumor fusion vaccine and higher dose IL-12~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells~Interleukin-12: Given subcutaneously at dose of 100ng/kg"
1076498|NCT00622401|P2|Participant Flow|Group 2: Dendritic Cell/Tumor Fusion Vaccine and Low Dose IL-1|"Dendritic Cell/tumor fusion vaccine and low dose IL-12~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells~Interleukin-12: Given subcutaneously at dose of 30ng/kg"
1076499|NCT00622401|P1|Participant Flow|Group 1: Dendritic Cell/Tumor Fusion Vaccine Only|"Dendritic Cell/Tumor Fusion Vaccine Only~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells"
1076500|NCT00622401|O1|Outcome|Group 1|"Dendritic Cell/Tumor Fusion Vaccine Only~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells"
1076501|NCT00622401|E1|Reported Event|Group 1|"Dendritic Cell/Tumor Fusion Vaccine Only~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells"
1076502|NCT00622388|B1|Baseline|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
1076503|NCT00622388|P1|Participant Flow|Ofatumumab|Participants received 8 weekly intravenous (iv) infusions of ofatumumab: first infusion of 300 milligrams (mg), followed by 7 infusions of 1000 mg
1076504|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
1076505|NCT00622388|O1|Outcome|Overall Study Arm|
1076506|NCT00622388|O1|Outcome|Overall Study Arm|
1076507|NCT00622388|O1|Outcome|Overall Study Arm|
1076508|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
1076565|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
1076509|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
1076510|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
1076511|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
1076512|NCT00622388|O1|Outcome|Overall Study Arm|
1076513|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
1076514|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
1076515|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
1076516|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
1076517|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
1076518|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
1076519|NCT00622388|E1|Reported Event|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
1076520|NCT00622336|B1|Baseline|Lenalidomide 25mg (CC-5013)|Oral 25mg daily on Days 1-21 every 28 days
1076521|NCT00622336|P1|Participant Flow|Lenalidomide 25mg|Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
1076522|NCT00622336|O1|Outcome|Lenalidomide 25mg (CC-5013)|Oral 25mg daily on Days 1-21 every 28 days
1076523|NCT00622336|O1|Outcome|Lenalidomide 25mg|Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
1076524|NCT00622336|O1|Outcome|Lenalidomide 25mg|Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
1076525|NCT00622336|O1|Outcome|Lenalidomide 25mg|Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
1076526|NCT00622336|O1|Outcome|Lenalidomide 25mg (CC-5013)|Oral 25mg daily on Days 1-21 every 28 days
1076527|NCT00622336|E2|Reported Event|Lenalidomide ( ExtensionPhase) 22 Oct 2009 to 11 November 2013|Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
1076528|NCT00622336|E1|Reported Event|Lenalidomide (Treatment Phase) Up to Data Cut-off 22 Oct 2009|Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
1076529|NCT00622284|B3|Baseline|Total|Total of all reporting groups
1076530|NCT00622284|B2|Baseline|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
1076531|NCT00622284|B1|Baseline|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
1076532|NCT00622284|P2|Participant Flow|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
1076533|NCT00622284|P1|Participant Flow|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
1076534|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
1076535|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
1076536|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
1076537|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
1076538|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
1076539|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
1076540|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
1076541|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
1076542|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
1076543|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
1076544|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
1076545|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
1076546|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
1076547|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
1076548|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
1076549|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
1076550|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
1076551|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
1076552|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
1076553|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
1076554|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
1076555|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
1076556|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
1076557|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
1076558|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
1076559|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
1076560|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
1076561|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
1076562|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
1076563|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
1076564|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
1076566|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
1076567|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
1076568|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
1076569|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
1076570|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
1076571|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
1076572|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
1076573|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
1076574|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
1076575|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
1076576|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
1076577|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
1076578|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
1076579|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
1076580|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
1076581|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
1076582|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
1076583|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
1076584|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
1076585|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
1076586|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
1076587|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
1076588|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
1076589|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
1076590|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
1076591|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
1076592|NCT00622284|E2|Reported Event|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
1076593|NCT00622284|E1|Reported Event|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
1076594|NCT00622167|B1|Baseline|IBIVUS and DSCT|All patients will receive integrated backscatter IVUS and dual source CT.
1076595|NCT00622167|P1|Participant Flow|IBIVUS and DSCT|All patients will receive integrated backscatter IVUS and dual source CT.
1076596|NCT00622167|O1|Outcome|Plaque Characteristics|Characteristics include plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology.
1076597|NCT00622167|E1|Reported Event|IBIVUS and DSCT|All patients will receive integrated backscatter IVUS and dual source CT.
1076598|NCT00621985|B1|Baseline|Experimental Group|These subjects were admitted twice, once while on baseline hydrocortisone and once on dexamethasone.
1076599|NCT00621985|P1|Participant Flow|Experimental|Baseline hydrocortisone was given at a dose determined by the subject's primary endocrinologist and was given either 2 or 3 times per day as per their home regimen. Experimental therapy with nocturnal dexamethasone given at a dose equivalent to 1/50th of the total daily hydrocortisone dose. This dose was given at 10 PM for three nights with the admission to the hospital occurring on the 3rd day prior to the 3rd evening dose.
1076600|NCT00621985|O2|Outcome|Hydrocortisone Admission|This is the first admission of the protocol during which the subject received hydrocortisone.
1076601|NCT00621985|O1|Outcome|Dexamethasone Admission|This is the second admission of the protocol during which the subject received dexamethasone.
1076602|NCT00621985|E2|Reported Event|Hydrocortisone Admission|This is the first admission of the protocol during which the subject received hydrocortisone.
1076603|NCT00621985|E1|Reported Event|Dexamethasone Admission|This is the second admission of the protocol during which the subject received dexamethasone.
1076604|NCT00621959|B3|Baseline|Total|Total of all reporting groups
1076605|NCT00621959|B2|Baseline|LCTZ|5 mg levocetirizine dihydrochloride tablet once daily
1076606|NCT00621959|B1|Baseline|Placebo|Matched placebo tablets once daily
1076607|NCT00621959|P2|Participant Flow|LCTZ|5 mg levocetirizine dihydrochloride tablet once daily
1076608|NCT00621959|P1|Participant Flow|Placebo|Matched placebo tablets once daily
1076609|NCT00621959|O2|Outcome|LCTZ|5 mg levocetirizine dihydrochloride tablet once daily
1076610|NCT00621959|O1|Outcome|Placebo|Matched placebo tablets once daily
1076611|NCT00621959|O2|Outcome|LCTZ|5 mg levocetirizine dihydrochloride tablet once daily
1076612|NCT00621959|O1|Outcome|Placebo|Matched placebo tablets once daily
1076613|NCT00621959|E2|Reported Event|LCTZ|5 mg levocetirizine dihydrochloride tablet once daily
1076614|NCT00621959|E1|Reported Event|Placebo|Matched placebo tablets once daily
1076615|NCT00621946|B3|Baseline|Total|Total of all reporting groups
1076616|NCT00621946|B2|Baseline|Placebo|Placebo Matching Escitalopram taken orally daily.
1076617|NCT00621946|B1|Baseline|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
1076618|NCT00621946|P2|Participant Flow|Matching Placebo|Placebo Matching Escitalopram taken orally daily (for a 12-week duration).
1076619|NCT00621946|P1|Participant Flow|Escitalopram|Once daily oral administration (for a 12-week duration) of 10 mg escitalopram tablets with an increase to 20 mg in those with a less than 30% decrease in HAM-D scores at week 4.
1076620|NCT00621946|O2|Outcome|Matching Placebo|Placebo Matching Escitalopram taken orally daily.
1076621|NCT00621946|O1|Outcome|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
1076622|NCT00621946|O2|Outcome|Matching Placebo|Placebo Matching Escitalopram taken orally daily.
1076623|NCT00621946|O1|Outcome|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
1076624|NCT00621946|O2|Outcome|Matching Placebo|Placebo Matching Escitalopram taken orally daily.
1076625|NCT00621946|O1|Outcome|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
1076626|NCT00621946|O2|Outcome|Placebo|Placebo Matching Escitalopram taken orally daily.
1076627|NCT00621946|O1|Outcome|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
1076628|NCT00621946|O2|Outcome|Placebo|Placebo Matching Escitalopram taken orally daily.
1076629|NCT00621946|O1|Outcome|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
1076630|NCT00621946|O2|Outcome|Placebo|Placebo Matching Escitalopram taken orally daily.
1076631|NCT00621946|O1|Outcome|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
1076632|NCT00621946|E2|Reported Event|Placebo|Placebo Matching Escitalopram taken orally daily.
1076633|NCT00621946|E1|Reported Event|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
1076634|NCT00621933|B1|Baseline|All Patients|All patients receiving cataract surgery
1076635|NCT00621933|P1|Participant Flow|All Patients|All patients receiving cataract surgery
1076636|NCT00621933|O1|Outcome|All Patients|All patients receiving cataract surgery
1076637|NCT00621933|O1|Outcome|All Patients|All patients receiving cataract surgery
1076638|NCT00621933|O1|Outcome|All Patients|All patients receiving cataract surgery
1076639|NCT00621933|O1|Outcome|All Patients|All patients receiving cataract surgery
1076640|NCT00621933|E1|Reported Event|All Patients|All patients receiving cataract surgery
1076641|NCT00621855|B6|Baseline|Total|Total of all reporting groups
1076642|NCT00621855|B5|Baseline|Placebo|26 week blinded treatment
1076643|NCT00621855|B4|Baseline|150mg Dabigatran Etexilate|26 week blinded treatment
1076644|NCT00621855|B3|Baseline|110mg Dabigatran Etexilate|26 week blinded treatment
1076645|NCT00621855|B2|Baseline|75mg Dabigatran Etexilate|26 week blinded treatment
1076646|NCT00621855|B1|Baseline|50mg Dabigatran Etexilate|26 week blinded treatment
1076647|NCT00621855|P5|Participant Flow|Placebo|26 week blinded treatment
1076648|NCT00621855|P4|Participant Flow|150mg Dabigatran Etexilate|26 week blinded treatment
1076649|NCT00621855|P3|Participant Flow|110mg Dabigatran Etexilate|26 week blinded treatment
1076650|NCT00621855|P2|Participant Flow|75mg Dabigatran Etexilate|26 week blinded treatment
1076651|NCT00621855|P1|Participant Flow|50mg Dabigatran Etexilate|26 week blinded treatment
1076652|NCT00621855|O5|Outcome|Placebo|26 week blinded treatment
1076653|NCT00621855|O4|Outcome|150mg Dabigatran Etexilate|26 week blinded treatment
1076654|NCT00621855|O3|Outcome|110mg Dabigatran Etexilate|26 week blinded treatment
1076655|NCT00621855|O2|Outcome|75mg Dabigatran Etexilate|26 week blinded treatment
1076656|NCT00621855|O1|Outcome|50mg Dabigatran Etexilate|26 week blinded treatment
1076657|NCT00621855|O5|Outcome|Placebo|26 week blinded treatment
1076658|NCT00621855|O4|Outcome|150mg Dabigatran Etexilate|26 week blinded treatment
1076659|NCT00621855|O3|Outcome|110mg Dabigatran Etexilate|26 week blinded treatment
1076660|NCT00621855|O2|Outcome|75mg Dabigatran Etexilate|26 week blinded treatment
1076661|NCT00621855|O1|Outcome|50mg Dabigatran Etexilate|26 week blinded treatment
1076662|NCT00621855|O5|Outcome|Placebo|26 week blinded treatment
1076663|NCT00621855|O4|Outcome|150mg Dabigatran Etexilate|26 week blinded treatment
1076664|NCT00621855|O3|Outcome|110mg Dabigatran Etexilate|26 week blinded treatment
1076665|NCT00621855|O2|Outcome|75mg Dabigatran Etexilate|26 week blinded treatment
1076666|NCT00621855|O1|Outcome|50mg Dabigatran Etexilate|26 week blinded treatment
1076667|NCT00621855|O5|Outcome|Placebo|26 week blinded treatment
1076668|NCT00621855|O4|Outcome|150mg Dabigatran Etexilate|26 week blinded treatment
1076669|NCT00621855|O3|Outcome|110mg Dabigatran Etexilate|26 week blinded treatment
1076670|NCT00621855|O2|Outcome|75mg Dabigatran Etexilate|26 week blinded treatment
1076671|NCT00621855|O1|Outcome|50mg Dabigatran Etexilate|26 week blinded treatment
1076672|NCT00621855|O5|Outcome|Placebo|26 week blinded treatment
1076673|NCT00621855|O4|Outcome|150mg Dabigatran Etexilate|26 week blinded treatment
1076674|NCT00621855|O3|Outcome|110mg Dabigatran Etexilate|26 week blinded treatment
1076675|NCT00621855|O2|Outcome|75mg Dabigatran Etexilate|26 week blinded treatment
1076676|NCT00621855|O1|Outcome|50mg Dabigatran Etexilate|26 week blinded treatment
1076677|NCT00621855|O5|Outcome|Placebo|26 week blinded treatment
1076678|NCT00621855|O4|Outcome|150mg Dabigatran Etexilate|26 week blinded treatment
1076679|NCT00621855|O3|Outcome|110mg Dabigatran Etexilate|26 week blinded treatment
1076680|NCT00621855|O2|Outcome|75mg Dabigatran Etexilate|26 week blinded treatment
1076681|NCT00621855|O1|Outcome|50mg Dabigatran Etexilate|26 week blinded treatment
1076682|NCT00621855|O5|Outcome|Placebo|26 week blinded treatment
1076683|NCT00621855|O4|Outcome|150mg Dabigatran Etexilate|26 week blinded treatment
1076684|NCT00621855|O3|Outcome|110mg Dabigatran Etexilate|26 week blinded treatment
1076685|NCT00621855|O2|Outcome|75mg Dabigatran Etexilate|26 week blinded treatment
1076686|NCT00621855|O1|Outcome|50mg Dabigatran Etexilate|26 week blinded treatment
1076687|NCT00621855|E5|Reported Event|Placebo|26 week blinded treatment
1076688|NCT00621855|E4|Reported Event|150mg Dabigatran Etexilate|26 week blinded treatment
1076689|NCT00621855|E3|Reported Event|110mg Dabigatran Etexilate|26 week blinded treatment
1076690|NCT00621855|E2|Reported Event|75mg Dabigatran Etexilate|26 week blinded treatment
1076691|NCT00621855|E1|Reported Event|50mg Dabigatran Etexilate|26 week blinded treatment
1076692|NCT00621842|B1|Baseline|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
1076693|NCT00621842|P1|Participant Flow|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
1076780|NCT00621582|P1|Participant Flow|Tiotropium Bromide|
1076694|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
1076695|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
1076696|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
1076697|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
1076698|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
1076699|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
1076700|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
1076701|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
1076702|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
1076703|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
1076704|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
1076705|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
1076706|NCT00621842|E1|Reported Event|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
1076707|NCT00621777|B3|Baseline|Total|Total of all reporting groups
1076708|NCT00621777|B2|Baseline|Placebo|"Placebo: At each weekly study visit from the baseline visit to study week 11,ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks.~In addition, participants who enter the relapse prevention phase and are randomized to the placebo condition will receive placebo pills for 40 weeks."
1076709|NCT00621777|B1|Baseline|Varenicline|"Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year. Varenicline has demonstrated safety when dosed at 1 mg twice per day for up to one year.~Varenicline: At each weekly study visit from the baseline visit to study week 11, ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks.~In addition, participants who enter the relapse prevention phase and are randomized to the varenicline condition will receive varenicline at the dose used to attain initial abstinence for 40 weeks."
1076710|NCT00621777|P2|Participant Flow|Placebo|"Placebo: At each weekly study visit from the baseline visit to study week 11,ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks.~In addition, participants who enter the relapse prevention phase and are randomized to the placebo condition will receive placebo pills for 40 weeks."
1076711|NCT00621777|P1|Participant Flow|Varenicline|"Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year.~Open label, smoking cessation phase: At each weekly study visit from the baseline visit to study wk 11, ALL subjects will receive a one-week supply of varenicline as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 wks.~Double-Blind, Placebo-Controlled, Relapse-Prevention Phase:~Participants in the open phase who met criteria for biochemically verified, 7-day, point-prevalence abstinence at wks 11 and 12 were considered to be continuously abstinent for at least 14 days and were randomized to continue varenicline, 1.0 mg twice a day, or switch to identical-appearing placebo for wks 12 through 52"
1076712|NCT00621777|O2|Outcome|Placebo|"Placebo: At each weekly study visit from the baseline visit to study week 11,ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks.~In addition, participants who enter the relapse prevention phase and are randomized to the placebo condition will receive placebo pills for 40 weeks."
1076713|NCT00621777|O1|Outcome|Varenicline|"Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year. Varenicline has demonstrated safety when dosed at 1 mg twice per day for up to one year.~Varenicline: At each weekly study visit from the baseline visit to study week 11, ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks.~In addition, participants who enter the relapse prevention phase and are randomized to the varenicline condition will receive varenicline at the dose used to attain initial abstinence for 40 weeks."
1076714|NCT00621777|E3|Reported Event|Placebo|2. Double-Blind, Placebo-Controlled, Relapse-Prevention Phase: Participants in the open phase who met criteria for biochemically verified, 7-day, point-prevalence abstinence at wks 11 and 12 were considered to be continuously abstinent for at least 14 days and were randomized to continue varenicline, 1.0 mg twice a day, or switch to identical-appearing placebo for wks 12 through 52
1076745|NCT00621764|O1|Outcome|JE-CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
1076746|NCT00621764|O4|Outcome|Hepatitis A/JE-CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
1076715|NCT00621777|E2|Reported Event|Varenicline|"Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year.~2. Double-Blind, Placebo-Controlled, Relapse-Prevention Phase: Participants in the open phase who met criteria for biochemically verified, 7-day, point-prevalence abstinence at wks 11 and 12 were considered to be continuously abstinent for at least 14 days and were randomized to continue varenicline, 1.0 mg twice a day, or switch to identical-appearing placebo for wks 12 through 52"
1076716|NCT00621777|E1|Reported Event|Varenicline Open Label (Open Phase)|"Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year.~1. Open label, smoking cessation phase: At each weekly study visit from the baseline visit to study wk 11, ALL subjects will receive a one-week supply of varenicline as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 wks."
1076717|NCT00621764|B5|Baseline|Total|Total of all reporting groups
1076718|NCT00621764|B4|Baseline|Hepatitis A/JE CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart
1076719|NCT00621764|B3|Baseline|JE CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
1076720|NCT00621764|B2|Baseline|Hepatitis A/JE CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart
1076721|NCT00621764|B1|Baseline|JE CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
1076722|NCT00621764|P4|Participant Flow|Hepatitis A/JE-CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
1076723|NCT00621764|P3|Participant Flow|JE-CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
1076724|NCT00621764|P2|Participant Flow|Hepatitis A/JE-CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
1076725|NCT00621764|P1|Participant Flow|JE-CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
1076726|NCT00621764|O4|Outcome|Hepatitis A/JE-CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
1076727|NCT00621764|O3|Outcome|JE-CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
1076728|NCT00621764|O2|Outcome|Hepatitis A/JE-CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
1076729|NCT00621764|O1|Outcome|JE-CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
1076730|NCT00621764|O4|Outcome|Hepatitis A/JE-CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
1076731|NCT00621764|O3|Outcome|JE-CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
1076732|NCT00621764|O2|Outcome|Hepatitis A/JE-CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
1076733|NCT00621764|O1|Outcome|JE-CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
1076734|NCT00621764|O4|Outcome|Hepatitis A/JE-CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
1076735|NCT00621764|O3|Outcome|JE-CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
1076736|NCT00621764|O2|Outcome|Hepatitis A/JE-CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
1076737|NCT00621764|O1|Outcome|JE-CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
1076738|NCT00621764|O4|Outcome|Hepatitis A/JE-CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart.
1076739|NCT00621764|O3|Outcome|JE-CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
1076740|NCT00621764|O2|Outcome|Hepatitis A/JE-CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
1076741|NCT00621764|O1|Outcome|JE-CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
1076742|NCT00621764|O4|Outcome|Hepatitis A/JE-CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
1076743|NCT00621764|O3|Outcome|JE-CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
1076744|NCT00621764|O2|Outcome|Hepatitis A/JE-CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
1076747|NCT00621764|O3|Outcome|JE-CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
1076748|NCT00621764|O2|Outcome|Hepatitis A/JE-CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
1076749|NCT00621764|O1|Outcome|JE-CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
1076750|NCT00621764|E4|Reported Event|Hepatitis A/JE CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart
1076751|NCT00621764|E3|Reported Event|JE CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
1076752|NCT00621764|E2|Reported Event|Hepatitis A/JE CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart
1076753|NCT00621764|E1|Reported Event|JE CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
1076754|NCT00621686|B3|Baseline|Total|Total of all reporting groups
1076755|NCT00621686|B2|Baseline|Sorafenib + Bevacizumab /Group B|Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
1076756|NCT00621686|B1|Baseline|Sorafenib + Bevacizumab/Group A|Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
1076757|NCT00621686|P2|Participant Flow|Sorafenib + Bevacizumab /Group B|Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
1076758|NCT00621686|P1|Participant Flow|Sorafenib + Bevacizumab/Group A|Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
1076759|NCT00621686|O2|Outcome|Sorafenib + Bevacizumab /Group B|Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
1076760|NCT00621686|O1|Outcome|Sorafenib + Bevacizumab/Group A|Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
1076761|NCT00621686|O2|Outcome|Sorafenib + Bevacizumab /Group B|Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
1076762|NCT00621686|O1|Outcome|Sorafenib + Bevacizumab/Group A|Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
1076763|NCT00621686|O2|Outcome|Sorafenib + Bevacizumab /Group B|Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
1076764|NCT00621686|O1|Outcome|Sorafenib + Bevacizumab/Group A|Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
1076765|NCT00621686|E2|Reported Event|Sorafenib + Bevacizumab /Group B|Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
1076766|NCT00621686|E1|Reported Event|Sorafenib + Bevacizumab/Group A|Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
1076767|NCT00621621|B4|Baseline|Total|Total of all reporting groups
1076768|NCT00621621|B3|Baseline|Subjects Collected From Published Data|Published evidence about the safety and efficacy of using Medtronic’s Freezor® 4 mm CryoCatheter has been reported since the initiation of the CryoFACTS-PAS. The results reported in the literature provide the supplemental data in the same study population as in the PAS and are included to meet the study objectives, as agreed upon with the FDA.
1076769|NCT00621621|B2|Baseline|Subjects Consented in the Study Not Ablated|Actual Subjects that were consented in the study that did not meet inclusion criteria.
1076770|NCT00621621|B1|Baseline|Focal Cryoablation Group|"Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.~Freezor® Cardiac Cryoablation Catheter CryoConsole System: cryoablation"
1076771|NCT00621621|P2|Participant Flow|External Data Supporting the Study|Data from published reports that include subjects that met inclusion criteria for study and contained data of Heart block.
1076772|NCT00621621|P1|Participant Flow|Focal Cryoablation Group|"Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.~Freezor® Cardiac Cryoablation Catheter CryoConsole System: cryoablation"
1076773|NCT00621621|O2|Outcome|External Data Supporting the Study|This arm was taken from pier reviewed published reports that include adult subjects ablated with the Freezor catheter for AVNRT.
1076774|NCT00621621|O1|Outcome|Experimental: Freezor Catheter for AVNRT|Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmiacryoablation
1076775|NCT00621621|O2|Outcome|External Data Supporting the Study|
1076776|NCT00621621|O1|Outcome|Focal Cryoablation Group|"Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.~Freezor® Cardiac Cryoablation Catheter CryoConsole System: cryoablation"
1076777|NCT00621621|E2|Reported Event|External Data Supporting the Study|"Subjects from publication search with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.~Freezor® Cardiac Cryoablation Catheter CryoConsole System: cryoablation"
1076778|NCT00621621|E1|Reported Event|Focal Cryoablation Group|"Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.~Freezor® Cardiac Cryoablation Catheter CryoConsole System: cryoablation"
1076781|NCT00621582|O1|Outcome|Tiotropium Bromide|
1076782|NCT00621582|O1|Outcome|Tiotropium Bromide|
1076783|NCT00621582|O1|Outcome|Tiotropium Bromide|
1076784|NCT00621582|O1|Outcome|Tiotropium Bromide|
1076785|NCT00621582|E1|Reported Event|Tiotropium Bromide|
1076786|NCT00621543|B1|Baseline|Observation- All Subjects|Women choosing intra-uterine contraception after medical abortion.
1076787|NCT00621543|P1|Participant Flow|Observation- All Subjects|Women choosing intra-uterine contraception after medical abortion.
1076788|NCT00621543|O1|Outcome|Single Arm Study|
1076789|NCT00621543|O1|Outcome|Single Arm Study|
1076790|NCT00621543|E1|Reported Event|Observation- All Subjects|Women choosing intra-uterine contraception after medical abortion.
1076791|NCT00621517|B3|Baseline|Total|Total of all reporting groups
1076792|NCT00621517|B2|Baseline|Placebo|Participants will receive matching placebo capsule nightly.
1076793|NCT00621517|B1|Baseline|Bupropion|Participants will receive 150MG Bupropion nightly.
1076794|NCT00621517|P2|Participant Flow|Placebo|Participants will receive matching placebo capsule nightly.
1076795|NCT00621517|P1|Participant Flow|Bupropion|Participants will receive 150MG Bupropion nightly.
1076796|NCT00621517|O2|Outcome|Placebo|Participants will receive matching placebo capsule nightly.
1076797|NCT00621517|O1|Outcome|Bupropion|Participants will receive 150MG Bupropion nightly.
1076798|NCT00621517|E2|Reported Event|Placebo|Participants will receive matching placebo capsule nightly.
1076799|NCT00621517|E1|Reported Event|Bupropion|Participants will receive 150MG Bupropion nightly.
1076800|NCT00621504|B3|Baseline|Total|Total of all reporting groups
1076801|NCT00621504|B2|Baseline|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
1076802|NCT00621504|B1|Baseline|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
1076803|NCT00621504|P2|Participant Flow|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
1076804|NCT00621504|P1|Participant Flow|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
1076805|NCT00621504|O2|Outcome|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
1076806|NCT00621504|O1|Outcome|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
1076807|NCT00621504|E2|Reported Event|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
1076808|NCT00621504|E1|Reported Event|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
1076809|NCT00621348|B4|Baseline|Total|Total of all reporting groups
1076810|NCT00621348|B3|Baseline|Hypotonic Saline|N/5 saline in 5% dextrose at standard maintenance rate
1076811|NCT00621348|B2|Baseline|Fluid Restriction Group|Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
1076812|NCT00621348|B1|Baseline|Dextrose Normal Saline|Normal saline in 5% dextrose at standard maintenance rate
1076813|NCT00621348|P3|Participant Flow|Hypotonic Saline|N/5 saline in 5% dextrose at standard maintenance rate
1076814|NCT00621348|P2|Participant Flow|Fluid Restriction Group|Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
1076815|NCT00621348|P1|Participant Flow|Dextrose Normal Saline|Normal saline in 5% dextrose at standard maintenance rate
1076816|NCT00621348|O3|Outcome|Hypotonic Saline|N/5 saline in 5% dextrose at standard maintenance rate
1076817|NCT00621348|O2|Outcome|Fluid Restriction Group|Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
1076818|NCT00621348|O1|Outcome|Dextrose Normal Saline|Normal saline in 5% dextrose at standard maintenance rate
1076819|NCT00621348|O3|Outcome|Hypotonic Saline|N/5 saline in 5% dextrose at standard maintenance rate
1076820|NCT00621348|O2|Outcome|Fluid Restriction Group|Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
1076821|NCT00621348|O1|Outcome|Dextrose Normal Saline|Normal saline in 5% dextrose at standard maintenance rate
1076822|NCT00621348|O3|Outcome|Hypotonic Saline|N/5 saline in 5% dextrose at standard maintenance rate
1076823|NCT00621348|O2|Outcome|Fluid Restriction Group|Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
1076824|NCT00621348|O1|Outcome|Dextrose Normal Saline|Normal saline in 5% dextrose at standard maintenance rate
1076825|NCT00621348|O3|Outcome|Hypotonic Saline|N/5 saline in 5% dextrose at standard maintenance rate
1076826|NCT00621348|O2|Outcome|Fluid Restriction Group|Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
1076827|NCT00621348|O1|Outcome|Dextrose Normal Saline|Normal saline in 5% dextrose at standard maintenance rate
1076828|NCT00621348|E3|Reported Event|Hypotonic Saline|N/5 saline in 5% dextrose at standard maintenance rate
1076829|NCT00621348|E2|Reported Event|Fluid Restriction Group|Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
1076830|NCT00621348|E1|Reported Event|Dextrose Normal Saline|Normal saline in 5% dextrose at standard maintenance rate
1076831|NCT00621322|B7|Baseline|Total|Total of all reporting groups
1076832|NCT00621322|B6|Baseline|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076833|NCT00621322|B5|Baseline|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076924|NCT00621296|O1|Outcome|MP-424|Drug: MP-424 750 mg every 8 hours for 24 weeks Other Name: Telaprevir
1076925|NCT00621296|E1|Reported Event|MP-424|Drug: MP-424 750 mg every 8 hours for 24 weeks Other Name: Telaprevir
1076834|NCT00621322|B4|Baseline|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076835|NCT00621322|B3|Baseline|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076836|NCT00621322|B2|Baseline|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076837|NCT00621322|B1|Baseline|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076838|NCT00621322|P6|Participant Flow|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076839|NCT00621322|P5|Participant Flow|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076840|NCT00621322|P4|Participant Flow|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076841|NCT00621322|P3|Participant Flow|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076842|NCT00621322|P2|Participant Flow|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076843|NCT00621322|P1|Participant Flow|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076844|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076845|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076846|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076847|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076848|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076849|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076850|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076851|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076852|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076853|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076854|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076855|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076926|NCT00621257|B6|Baseline|Total|Total of all reporting groups
1076930|NCT00621257|B2|Baseline|Treatment B|"2,000 IU/day of vitamin D3 orally for 6 weeks~Cholecalciferol: 400 units per drop"
1076856|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076857|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076858|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076859|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076860|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076861|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076862|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076863|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076864|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076865|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076866|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076867|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076868|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076869|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076870|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076871|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076872|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076873|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076874|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076875|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076876|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076877|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076927|NCT00621257|B5|Baseline|Maintenance B|"2,000 IU/day of vitamin D2 orally from November 1 to April 30, and 1,000 IU/day of vitamin D2 orally for the remainder of the year over 2 years~ergocalciferol: 8000 units/ml"
1076878|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076879|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076880|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076881|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076882|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076883|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076884|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076885|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076886|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076887|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076888|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076889|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076890|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076891|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076892|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076893|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076894|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076895|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076896|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076897|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076898|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076899|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076928|NCT00621257|B4|Baseline|Maintenance A|"400 IU/day of vitamin D2 orally over 2 years (control arm)~ergocalciferol: 8000 units/ml"
1076929|NCT00621257|B3|Baseline|Treatment C|"50,000 IU of vitamin D2 once a week orally for 6 weeks~ergocalciferol: 8000 units/ml"
1076900|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076901|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076902|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076903|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076904|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076905|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076906|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076907|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076908|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076909|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076910|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076911|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076912|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076913|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076914|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076915|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076916|NCT00621322|E6|Reported Event|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076917|NCT00621322|E5|Reported Event|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076918|NCT00621322|E4|Reported Event|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076919|NCT00621322|E3|Reported Event|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076920|NCT00621322|E2|Reported Event|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076921|NCT00621322|E1|Reported Event|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
1076922|NCT00621296|B1|Baseline|MP-424|Drug: MP-424 750 mg every 8 hours for 24 weeks Other Name: Telaprevir
1076923|NCT00621296|P1|Participant Flow|MP-424|Drug: MP-424 750 mg every 8 hours for 24 weeks Other Name: Telaprevir
1076931|NCT00621257|B1|Baseline|Treatment A|"2,000 IU/day of vitamin D2 orally for 6 weeks (control arm)~ergocalciferol: 8000 units/ml"
1076932|NCT00621257|P5|Participant Flow|Maintenance B|"2,000 IU/day of vitamin D2 orally from November 1 to April 30, and 1,000 IU/day of vitamin D2 orally for the remainder of the year over 2 years~ergocalciferol: 8000 units/ml"
1076933|NCT00621257|P4|Participant Flow|Maintenance A|"400 IU/day of vitamin D2 orally over 2 years (control arm)~ergocalciferol: 8000 units/ml"
1076934|NCT00621257|P3|Participant Flow|Treatment C|"50,000 IU of vitamin D2 once a week orally for 6 weeks~ergocalciferol: 8000 units/ml"
1076935|NCT00621257|P2|Participant Flow|Treatment B|"2,000 IU/day of vitamin D3 orally for 6 weeks~Cholecalciferol: 400 units per drop"
1076936|NCT00621257|P1|Participant Flow|Treatment A|"2,000 IU/day of vitamin D2 orally for 6 weeks (control arm)~ergocalciferol: 8000 units/ml"
1076937|NCT00621257|O2|Outcome|Maintenance B|"2,000 IU/day of vitamin D2 orally from November 1 to April 30, and 1,000 IU/day of vitamin D2 orally for the remainder of the year over 2 years~ergocalciferol: 8000 units/ml"
1076938|NCT00621257|O1|Outcome|Maintenance A|"400 IU/day of vitamin D2 orally over 2 years (control arm)~ergocalciferol: 8000 units/ml"
1076939|NCT00621257|O3|Outcome|Treatment C|"50,000 IU of vitamin D2 once a week orally for 6 weeks~ergocalciferol: 8000 units/ml"
1076940|NCT00621257|O2|Outcome|Treatment B|"2,000 IU/day of vitamin D3 orally for 6 weeks~Cholecalciferol: 400 units per drop"
1076941|NCT00621257|O1|Outcome|Treatment A|"2,000 IU/day of vitamin D2 orally for 6 weeks (control arm)~ergocalciferol: 8000 units/ml"
1076942|NCT00621257|E5|Reported Event|Maintenance B|"1,000 IU of oral vitamin D2 per day from May to October and 2,000 IU of oral vitamin D2 per day of oral vitamin D2 per day from November to April~ergocalciferol 8000 IU/ml"
1076943|NCT00621257|E4|Reported Event|Maintenance A|"400 IU per day of oral vitamin D2~ergocalciferol 8000 IU/ml"
1076944|NCT00621257|E3|Reported Event|Treatment C|"50,000 IU of vitamin D2 once a week orally for 6 weeks~ergocalciferol: 8000 units/ml"
1076945|NCT00621257|E2|Reported Event|Treatment B|"2,000 IU/day of vitamin D3 orally for 6 weeks~Cholecalciferol: 400 units per drop"
1076946|NCT00621257|E1|Reported Event|Treatment A|"2,000 IU/day of vitamin D2 orally for 6 weeks (control arm)~ergocalciferol: 8000 units/ml"
1076947|NCT00620126|B3|Baseline|Total|Total of all reporting groups
1076948|NCT00620126|B2|Baseline|Control|Best Available Care
1076949|NCT00620126|B1|Baseline|Intervention|UC Home Automated Telemanagement
1076950|NCT00620126|P2|Participant Flow|Best Available Care|The standard of care for participants in this study is modeled after the standard of care at our institution, and based on current evidence-based guidelines including comprehensive assessment, a guideline-concordant therapy plan, scheduled and as needed clinic visits, scheduled and as needed telephone calls, and administration of educational fact sheets about disease-specific topics when appropriate. We expanded the care received by controls to make the groups more comparable. First, we provided the control group with all currently available educational fact sheets from the Crohn’s and Colitis Foundation at the time of group allocation. Second, we provided the control group with individualized written action plans at the time of group assignment without reinforcement.
1076951|NCT00620126|P1|Participant Flow|UC Home Automated Telemanagement|The UC HAT home unit consists of a netbook computer and an electronic weight scale. Participants answer questions regarding symptoms, side effects, adherence, and receive disease-specific education using the home unit. The home unit automatically transmits the results to the decision support server after each self-testing session. Participants completed self-testing weekly. Updated action plans are automatically transmitted to participant home units if certain criteria are met. If certain clinical conditions are met, email alerts are sent to the nurse coordinator. The coordinator reviews the information and if necessary consults the medical provider and the participant for management changes.
1076952|NCT00620126|O2|Outcome|Control|Best Available Care
1076953|NCT00620126|O1|Outcome|Intervention|UC Home Automated Telemanagement
1076954|NCT00620126|O2|Outcome|Control|Best Available Care
1076955|NCT00620126|O1|Outcome|Intervention|UC Home Automated Telemanagement
1076956|NCT00620126|O2|Outcome|Control|Best Available Care
1076957|NCT00620126|O1|Outcome|Intervention|UC Home Automated Telemanagement
1076958|NCT00620126|E2|Reported Event|Control|Best Available Care
1076959|NCT00620126|E1|Reported Event|Intervention|UC Home Automated Telemanagement
1076960|NCT00620113|B5|Baseline|Total|Total of all reporting groups
1076961|NCT00620113|B4|Baseline|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076962|NCT00620113|B3|Baseline|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076963|NCT00620113|B2|Baseline|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076964|NCT00620113|B1|Baseline|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076965|NCT00620113|P4|Participant Flow|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1077028|NCT00621192|O2|Outcome|2. GA <32 Wks; PNA 91days ≥ 2Wks|Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
1077357|NCT00620282|B4|Baseline|Total|Total of all reporting groups
1076966|NCT00620113|P3|Participant Flow|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076967|NCT00620113|P2|Participant Flow|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076968|NCT00620113|P1|Participant Flow|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 International Units (IU) vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076969|NCT00620113|O4|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076970|NCT00620113|O3|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076971|NCT00620113|O2|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076972|NCT00620113|O1|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076973|NCT00620113|O4|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076974|NCT00620113|O3|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076975|NCT00620113|O2|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076976|NCT00620113|O1|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076977|NCT00620113|O4|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076978|NCT00620113|O3|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076979|NCT00620113|O2|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076980|NCT00620113|O1|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076981|NCT00620113|O4|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076982|NCT00620113|O3|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076983|NCT00620113|O2|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1077029|NCT00621192|O1|Outcome|1. GA <32 Wks; PNA<2 Wks|Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
1077030|NCT00621192|O4|Outcome|4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks|Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.
1076984|NCT00620113|O1|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076985|NCT00620113|O4|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076986|NCT00620113|O3|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076987|NCT00620113|O2|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076988|NCT00620113|O1|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076989|NCT00620113|O4|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076990|NCT00620113|O3|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076991|NCT00620113|O2|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076992|NCT00620113|O1|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076993|NCT00620113|O4|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076994|NCT00620113|O3|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076995|NCT00620113|O2|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076996|NCT00620113|O1|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076997|NCT00620113|O4|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076998|NCT00620113|O3|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1076999|NCT00620113|O2|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1077000|NCT00620113|O1|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1077001|NCT00620113|O4|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1077031|NCT00621192|O3|Outcome|3. GA ≥ 32 Wks; PNA <2 Wks|Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
1077032|NCT00621192|O2|Outcome|2. GA <32 Wks; PNA 91days ≥ 2Wks|Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
1079584|NCT00615108|O1|Outcome|Micardis 40mg|Telmisartan 40 mg
1077002|NCT00620113|O3|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1077003|NCT00620113|O2|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1077004|NCT00620113|O1|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1077005|NCT00620113|O4|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1077006|NCT00620113|O3|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1077007|NCT00620113|O2|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1077008|NCT00620113|O1|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1077009|NCT00620113|O4|Outcome|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1077010|NCT00620113|O3|Outcome|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1077011|NCT00620113|O2|Outcome|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1077012|NCT00620113|O1|Outcome|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1077013|NCT00620113|E4|Reported Event|Odanacatib 50 mg|After an observation period of ~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1077014|NCT00620113|E3|Reported Event|Odanacatib 25 mg|After an observation period of ~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1077015|NCT00620113|E2|Reported Event|Odanacatib 10 mg|After an observation period of ~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1077016|NCT00620113|E1|Reported Event|Placebo|After an observation period of ~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium <1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
1077017|NCT00621192|B5|Baseline|Total|Total of all reporting groups
1077018|NCT00621192|B4|Baseline|4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks|Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.
1077019|NCT00621192|B3|Baseline|3. GA ≥ 32 Wks; PNA <2 Wks|Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
1077020|NCT00621192|B2|Baseline|2. GA <32 Wks; PNA 91days ≥ 2Wks|Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
1077021|NCT00621192|B1|Baseline|1. GA <32 Wks; PNA<2 Wks|Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
1077022|NCT00621192|P4|Participant Flow|4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks|Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.
1077023|NCT00621192|P3|Participant Flow|3. GA ≥ 32 Wks; PNA <2 Wks|Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
1077024|NCT00621192|P2|Participant Flow|2. GA <32 Wks; PNA 91days ≥ 2Wks|Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
1077025|NCT00621192|P1|Participant Flow|1. GA <32 Wks; PNA<2 Wks|Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
1077026|NCT00621192|O4|Outcome|4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks|Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.
1077027|NCT00621192|O3|Outcome|3. GA ≥ 32 Wks; PNA <2 Wks|Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
1077033|NCT00621192|O1|Outcome|1. GA <32 Wks; PNA<2 Wks|Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
1077034|NCT00621192|O4|Outcome|4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks|Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.
1077035|NCT00621192|O3|Outcome|3. GA ≥ 32 Wks; PNA <2 Wks|Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
1077036|NCT00621192|O2|Outcome|2. GA <32 Wks; PNA 91days ≥ 2Wks|Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
1077037|NCT00621192|O1|Outcome|1. GA <32 Wks; PNA<2 Wks|Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
1077038|NCT00621192|O4|Outcome|4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks|Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.
1077039|NCT00621192|O3|Outcome|3. GA ≥ 32 Wks; PNA <2 Wks|Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
1077040|NCT00621192|O2|Outcome|2. GA <32 Wks; PNA 91days ≥ 2Wks|Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
1077041|NCT00621192|O1|Outcome|1. GA <32 Wks; PNA<2 Wks|Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
1077042|NCT00621192|E4|Reported Event|4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks|Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.
1077043|NCT00621192|E3|Reported Event|3. GA ≥ 32 Wks; PNA <2 Wks|Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
1077044|NCT00621192|E2|Reported Event|2. GA <32 Wks; PNA 91days ≥ 2Wks|Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
1077045|NCT00621192|E1|Reported Event|1. GA <32 Wks; PNA<2 Wks|Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
1077046|NCT00621153|B3|Baseline|Total|Total of all reporting groups
1077047|NCT00621153|B2|Baseline|Candesartan Cilexetil Monotherapy|candesartan cilexetil monotherapy
1077048|NCT00621153|B1|Baseline|Candesartan Cilexetil/Hydroclorozide Combination Therapy|candesartan cilexetil/Hydroclorozide combination therapy
1077049|NCT00621153|P2|Participant Flow|Candesartan Cilexetil Monotherapy|candesartan cilexetil monotherapy
1077050|NCT00621153|P1|Participant Flow|Candesartan Cilexetil/Hydroclorozide Combination Therapy|candesartan cilexetil/Hydroclorozide combination therapy
1077051|NCT00621153|O2|Outcome|Candesartan Cilexetil Monotherapy|candesartan cilexetil monotherapy
1077052|NCT00621153|O1|Outcome|Candesartan Cilexetil/Hydroclorozide Combination Therapy|candesartan cilexetil/Hydroclorozide combination therapy
1077053|NCT00621153|E2|Reported Event|Candesartan Cilexetil Monotherapy|candesartan cilexetil monotherapy
1077054|NCT00621153|E1|Reported Event|Candesartan Cilexetil/Hydroclorozide Combination Therapy|candesartan cilexetil/Hydroclorozide combination therapy
1077055|NCT00621140|B3|Baseline|Total|Total of all reporting groups
1077056|NCT00621140|B2|Baseline|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
1077057|NCT00621140|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
1077058|NCT00621140|P2|Participant Flow|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
1077059|NCT00621140|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
1077060|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
1077061|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1077062|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
1077063|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1077064|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
1077065|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1077066|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
1077067|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1077068|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
1077069|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1077070|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
1077071|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1077072|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
1077073|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1077074|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
1077075|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1077076|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
1077077|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1077078|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
1077079|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1077080|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
1077081|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1077082|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
1077083|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1077084|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
1077085|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1077086|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
1077087|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1077088|NCT00621140|E2|Reported Event|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
1077089|NCT00621140|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
1077090|NCT00621049|B3|Baseline|Total|Total of all reporting groups
1077135|NCT00620828|B1|Baseline|Control Group|Subjects receive intra-op saline injection per protocol
1077091|NCT00621049|B2|Baseline|Docetaxel and Carboplatin|"Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:~Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1~Docetaxel should be administered before carboplatin.~Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
1077092|NCT00621049|B1|Baseline|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1~Docetaxel should be administered before carboplatin.~After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:~Maintenance Treatment for patients in Cohort A:~Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily~Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
1077201|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
1077093|NCT00621049|P2|Participant Flow|Docetaxel and Carboplatin|"Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:~Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1~Docetaxel should be administered before carboplatin.~Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
1077094|NCT00621049|P1|Participant Flow|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1~Docetaxel should be administered before carboplatin.~After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:~Maintenance Treatment for patients in Cohort A:~Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily~Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
1077095|NCT00621049|O2|Outcome|Docetaxel and Carboplatin|"Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:~Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1~Docetaxel should be administered before carboplatin.~Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
1077096|NCT00621049|O1|Outcome|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1~Docetaxel should be administered before carboplatin.~After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:~Maintenance Treatment for patients in Cohort A:~Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily~Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
1077097|NCT00621049|O2|Outcome|Docetaxel and Carboplatin|"Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:~Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1~Docetaxel should be administered before carboplatin.~Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
1077098|NCT00621049|O1|Outcome|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1~Docetaxel should be administered before carboplatin.~After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:~Maintenance Treatment for patients in Cohort A:~Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily~Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
1077099|NCT00621049|O2|Outcome|Docetaxel and Carboplatin|"Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:~Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1~Docetaxel should be administered before carboplatin.~Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
1077100|NCT00621049|O1|Outcome|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1~Docetaxel should be administered before carboplatin.~After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:~Maintenance Treatment for patients in Cohort A:~Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily~Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
1077101|NCT00621049|O2|Outcome|Docetaxel and Carboplatin|"Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:~Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1~Docetaxel should be administered before carboplatin.~Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
1077102|NCT00621049|O1|Outcome|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1~Docetaxel should be administered before carboplatin.~After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:~Maintenance Treatment for patients in Cohort A:~Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily~Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
1077103|NCT00621049|E2|Reported Event|Docetaxel and Carboplatin|"Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:~Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1~Docetaxel should be administered before carboplatin.~Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
1077104|NCT00621049|E1|Reported Event|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1~Docetaxel should be administered before carboplatin.~After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:~Maintenance Treatment for patients in Cohort A:~Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily~Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
1077105|NCT00621023|B1|Baseline|All Participants|"Drug: Decitabine, Arsenic Trioxide and Ascorbic Acid for MDS~Decitabine, Arsenic Trioxide and Ascorbic Acid : Subjects receive decitabine 20 mg/m2 IV over one hour for days1-5 of each cycle, and arsenic trioxide 0.25 mg/kg IV for days 1-5 of cycle 1 followed by 0.25 mg/kg twice weekly (Mon-Thursday or Tues-Fri) for all remaining cycles. Patients will have transfusion and supportive care therapy administered per the treating physician's discretion. Patients with a response after 4 cycles of therapy may choose to continue on two more cycles of decitabine with arsenic and ascorbic acid given only during the first week of those two additional cycles."
1077136|NCT00620828|P2|Participant Flow|Block Group|Subjects receive intra-op Ropivicaine 0.5% injection per protocol
1077137|NCT00620828|P1|Participant Flow|Control Group|Subjects receive intra-op saline injection per protocol
1077106|NCT00621023|P1|Participant Flow|All Participants|"Drug: Decitabine, Arsenic Trioxide and Ascorbic Acid for MDS~Decitabine, Arsenic Trioxide and Ascorbic Acid : Subjects receive decitabine 20 mg/m2 IV over one hour for days1-5 of each cycle, and arsenic trioxide 0.25 mg/kg IV for days 1-5 of cycle 1 followed by 0.25 mg/kg twice weekly (Mon-Thursday or Tues-Fri) for all remaining cycles. Patients will have transfusion and supportive care therapy administered per the treating physician's discretion. Patients with a response after 4 cycles of therapy may choose to continue on two more cycles of decitabine with arsenic and ascorbic acid given only during the first week of those two additional cycles."
1077140|NCT00620828|O2|Outcome|Control Group|Participants received a 20 mL posterior capsular injection of saline before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of saline.
1077107|NCT00621023|O1|Outcome|All Participants|"Drug: Decitabine, Arsenic Trioxide and Ascorbic Acid for MDS~Decitabine, Arsenic Trioxide and Ascorbic Acid : Subjects receive decitabine 20 mg/m2 IV over one hour for days1-5 of each cycle, and arsenic trioxide 0.25 mg/kg IV for days 1-5 of cycle 1 followed by 0.25 mg/kg twice weekly (Mon-Thursday or Tues-Fri) for all remaining cycles. Patients will have transfusion and supportive care therapy administered per the treating physician's discretion. Patients with a response after 4 cycles of therapy may choose to continue on two more cycles of decitabine with arsenic and ascorbic acid given only during the first week of those two additional cycles."
1077108|NCT00621023|O1|Outcome|All Participants|"Drug: Decitabine, Arsenic Trioxide and Ascorbic Acid for MDS~Decitabine, Arsenic Trioxide and Ascorbic Acid : Subjects receive decitabine 20 mg/m2 IV over one hour for days1-5 of each cycle, and arsenic trioxide 0.25 mg/kg IV for days 1-5 of cycle 1 followed by 0.25 mg/kg twice weekly (Mon-Thursday or Tues-Fri) for all remaining cycles. Patients will have transfusion and supportive care therapy administered per the treating physician's discretion. Patients with a response after 4 cycles of therapy may choose to continue on two more cycles of decitabine with arsenic and ascorbic acid given only during the first week of those two additional cycles."
1077109|NCT00621023|O1|Outcome|All Participants|"Drug: Decitabine, Arsenic Trioxide and Ascorbic Acid for MDS~Decitabine, Arsenic Trioxide and Ascorbic Acid : Subjects receive decitabine 20 mg/m2 IV over one hour for days1-5 of each cycle, and arsenic trioxide 0.25 mg/kg IV for days 1-5 of cycle 1 followed by 0.25 mg/kg twice weekly (Mon-Thursday or Tues-Fri) for all remaining cycles. Patients will have transfusion and supportive care therapy administered per the treating physician's discretion. Patients with a response after 4 cycles of therapy may choose to continue on two more cycles of decitabine with arsenic and ascorbic acid given only during the first week of those two additional cycles."
1077110|NCT00621023|E1|Reported Event|All Participants|"Drug: Decitabine, Arsenic Trioxide and Ascorbic Acid for MDS~Decitabine, Arsenic Trioxide and Ascorbic Acid : Subjects receive decitabine 20 mg/m2 IV over one hour for days1-5 of each cycle, and arsenic trioxide 0.25 mg/kg IV for days 1-5 of cycle 1 followed by 0.25 mg/kg twice weekly (Mon-Thursday or Tues-Fri) for all remaining cycles. Patients will have transfusion and supportive care therapy administered per the treating physician's discretion. Patients with a response after 4 cycles of therapy may choose to continue on two more cycles of decitabine with arsenic and ascorbic acid given only during the first week of those two additional cycles."
1077111|NCT00620854|B7|Baseline|Total|Total of all reporting groups
1077112|NCT00620854|B6|Baseline|Fortical Then rsCTB Then rsCTA|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
1077113|NCT00620854|B5|Baseline|Fortical Then rsCTA Then rsCTB|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
1077114|NCT00620854|B4|Baseline|rsCTB Then Fortical Then rsCTA|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
1077115|NCT00620854|B3|Baseline|rsCTB Then rsCTA Then Fortical|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
1077116|NCT00620854|B2|Baseline|rsCTA Then Fortical Then rsCTB|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
1077117|NCT00620854|B1|Baseline|rsCTA Then rsCTB Then Fortical|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
1077118|NCT00620854|P6|Participant Flow|Fortical Then rsCTB Then rsCTA|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
1077119|NCT00620854|P5|Participant Flow|Fortical Then rsCTA Then rsCTB|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
1077120|NCT00620854|P4|Participant Flow|rsCTB Then Fortical Then rsCTA|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
1077121|NCT00620854|P3|Participant Flow|rsCTB Then rsCTA Then Fortical|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
1077122|NCT00620854|P2|Participant Flow|rsCTA Then Fortical Then rsCTB|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
1077123|NCT00620854|P1|Participant Flow|rsCTA Then rsCTB Then Fortical|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
1077124|NCT00620854|O3|Outcome|Fortical®|Fortical nasal spray (200 IU)
1077125|NCT00620854|O2|Outcome|rsCTB|Oral rsCT (200 micrograms)
1077126|NCT00620854|O1|Outcome|rsCT A|Oral rsCT (150 micrograms)
1077127|NCT00620854|E6|Reported Event|Fortical Then rsCTB Then rsCTA|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
1077128|NCT00620854|E5|Reported Event|Fortical Then rsCTA Then rsCTB|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
1077129|NCT00620854|E4|Reported Event|rsCTB Then Fortical Then rsCTA|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
1077130|NCT00620854|E3|Reported Event|rsCTB Then rsCTA Then Fortical|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
1077131|NCT00620854|E2|Reported Event|rsCTA Then Fortical Then rsCTB|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
1077132|NCT00620854|E1|Reported Event|rsCTA Then rsCTB Then Fortical|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
1077133|NCT00620828|B3|Baseline|Total|Total of all reporting groups
1077134|NCT00620828|B2|Baseline|Block Group|Subjects receive intra-op Ropivicaine 0.5% injection per protocol
1077138|NCT00620828|O2|Outcome|Control Group|Participants received a 20 mL posterior capsular injection of saline before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of saline.
1077139|NCT00620828|O1|Outcome|Block Group|Participants received a 20 mL posterior capsular injection of ropivicaine before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of ropivicaine.
1078317|NCT00618371|P1|Participant Flow|Group 1|group to be treated with raltegravir
1077141|NCT00620828|O1|Outcome|Block Group|Participants received a 20 mL posterior capsular injection of ropivicaine before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of ropivicaine.
1077142|NCT00620828|O2|Outcome|Control Group|Participants received a 20 mL posterior capsular injection of saline before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of saline.
1077143|NCT00620828|O1|Outcome|Block Group|Participants received a 20 mL posterior capsular injection of ropivicaine before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of ropivicaine.
1077144|NCT00620828|O2|Outcome|Control Group|Participants received a 20 mL posterior capsular injection of saline before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of saline.
1077145|NCT00620828|O1|Outcome|Block Group|Participants received a 20 mL posterior capsular injection of ropivicaine before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of ropivicaine.
1077146|NCT00620828|O2|Outcome|Control Group|Participants received a 20 mL posterior capsular injection of saline before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of saline.
1077147|NCT00620828|O1|Outcome|Block Group|Participants received a 20 mL posterior capsular injection of ropivicaine before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of ropivicaine.
1077148|NCT00620828|E2|Reported Event|Block Group|Subjects receive intra-op Ropivicaine 0.5% injection per protocol
1077149|NCT00620828|E1|Reported Event|Control Group|Subjects receive intra-op saline injection per protocol
1077150|NCT00620815|B4|Baseline|Total|Total of all reporting groups
1077151|NCT00620815|B3|Baseline|A/S-A|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal(S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
1077152|NCT00620815|B2|Baseline|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
1077153|NCT00620815|B1|Baseline|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
1077154|NCT00620815|P3|Participant Flow|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal (S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
1077155|NCT00620815|P2|Participant Flow|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
1077156|NCT00620815|P1|Participant Flow|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
1077157|NCT00620815|O3|Outcome|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal (S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
1077158|NCT00620815|O2|Outcome|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
1077159|NCT00620815|O1|Outcome|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
1077160|NCT00620815|O3|Outcome|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal(S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
1077161|NCT00620815|O2|Outcome|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
1077162|NCT00620815|O1|Outcome|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
1077163|NCT00620815|O3|Outcome|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal (S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
1077164|NCT00620815|O2|Outcome|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
1077165|NCT00620815|O1|Outcome|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
1077166|NCT00620815|O3|Outcome|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal (S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
1077167|NCT00620815|O2|Outcome|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
1077168|NCT00620815|O1|Outcome|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
1077169|NCT00620815|O3|Outcome|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal (S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
1077170|NCT00620815|O2|Outcome|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
1077171|NCT00620815|O1|Outcome|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
1077172|NCT00620815|O6|Outcome|A/S-A: After 2nd Vaccination|Systemic reactions after second vaccination after one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed 3 to 5 weeks later by Aflunov (A)
1077173|NCT00620815|O5|Outcome|A/P-T: After 2nd Vaccination|Systemic reactions after second vaccination after one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed 3 to 5 weeks later by tetravalent influenza vaccine (T)
1077174|NCT00620815|O4|Outcome|T/P-A: After 2nd Vaccination|Systemic reactions after second vaccination after one dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed 3 to 5 weeks later by Aflunov (A)
1077175|NCT00620815|O3|Outcome|A/S-A: After 1st Vaccination|Systemic reactions after first vaccination after one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed 3 to 5 weeks later by Aflunov (A)
1077176|NCT00620815|O2|Outcome|A/P-T: After 1st Vaccination|Systemic reactions after first vaccination after one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed 3 to 5 weeks later by tetravalent influenza vaccine (T)
1077177|NCT00620815|O1|Outcome|T/P-A: After 1st Vaccination|Systemic reactions after first vaccination after one dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed 3 to 5 weeks later by Aflunov (A)
1077178|NCT00620815|O3|Outcome|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal(S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
1077179|NCT00620815|O2|Outcome|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
1077180|NCT00620815|O1|Outcome|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
1077181|NCT00620815|O6|Outcome|A/S-A: In Arm Receiving Seasonal Influenza Vaccine (S)|Local reactions after first vaccination in arm receiving seasonal influenza vaccination in group receiving one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed Aflunov (A) on day 22
1077182|NCT00620815|O5|Outcome|A/S-A: In Arm Receiving Aflunov (A)|Local reactions after first vaccination in arm receiving Aflunov in group receiving one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed Aflunov (A) bon day 22
1077183|NCT00620815|O4|Outcome|A/P-T: In Arm Receiving Placebo (P)|Local reactions after first vaccination in arm receiving Placebo in group receiving one dose of the Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Tetravalent influenza vaccine (T) on day 22
1077184|NCT00620815|O3|Outcome|A/P-T: In Arm Receiving Aflunov (A)|Local reactions after first vaccination in arm receiving Aflunov in group receiving one dose of the Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Tetravalent influenza vaccine(T) on day 22
1077185|NCT00620815|O2|Outcome|T/P-A: In Arm Receiving Placebo (P)|Local reactions after first vaccination in arm receiving placebo in group receiving one dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Aflunov (A) on day 22
1077186|NCT00620815|O1|Outcome|T/P-A: In Arm Receiving Tetravalent Vaccine (T)|Local reactions after first vaccination in arm receiving tetravalent influenza vaccine in group receiving one dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Aflunov (A) on day 22
1077187|NCT00620815|O3|Outcome|A/S-A|One dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed Aflunov (A) on day 22
1077188|NCT00620815|O2|Outcome|A/P-T|One dose of the Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Tetravalent influenza vaccine (T) on day 22
1077189|NCT00620815|O1|Outcome|T/P-A|One dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Aflunov (A) on day 22
1077190|NCT00620815|E3|Reported Event|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal (S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
1077191|NCT00620815|E2|Reported Event|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
1077192|NCT00620815|E1|Reported Event|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
1077193|NCT00620776|B3|Baseline|Total|Total of all reporting groups
1077194|NCT00620776|B2|Baseline|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
1077195|NCT00620776|B1|Baseline|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
1077196|NCT00620776|P2|Participant Flow|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
1077197|NCT00620776|P1|Participant Flow|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
1077198|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
1077199|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
1077200|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
1077202|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
1077203|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
1077204|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
1077205|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
1077206|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
1077207|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
1077208|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
1077209|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
1077210|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
1077211|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
1077212|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
1077213|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
1077214|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
1077215|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
1077216|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
1077217|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
1077218|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
1077219|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
1077220|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
1077221|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
1077222|NCT00620776|E2|Reported Event|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
1077223|NCT00620776|E1|Reported Event|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
1077224|NCT00620763|B1|Baseline|Entire Study Population|Dietary Intervention: Crossover design, High meat and high potential renal acid load (high PRAL) diet and low meat and low potential renal acid load (low PRAL) diet, consumed in random order.
1077225|NCT00620763|P2|Participant Flow|Low Meat & Low Potential Renal Acid Load - First|Low meat and low potential renal acid load (low PRAL) followed by High meat and high potential renal acid load (high PRAL) diet.
1077226|NCT00620763|P1|Participant Flow|High Meat & High Potential Renal Acid Load - First|High meat and high potential renal acid load (high PRAL) diet followed by low meat and low potential renal acid load (low PRAL) diet.
1077227|NCT00620763|O2|Outcome|Low Meat - Low Potential Renal Acid Load|Low meat and low potential renal acid load (low PRAL) diet in either the first or second intervention period
1077228|NCT00620763|O1|Outcome|High Meat - High Potential Renal Acid Load|High meat and high potential renal acid load (high PRAL) diet in either the first or second intervention period
1077229|NCT00620763|E2|Reported Event|Low Meat & Low Potential Renal Acid Load - First|Low meat and low potential renal acid load (low PRAL) followed by High meat and high potential renal acid load (high PRAL) diet.
1077230|NCT00620763|E1|Reported Event|High Meat & High Potential Renal Acid Load - First|High meat and high potential renal acid load (high PRAL) diet followed by low meat and low potential renal acid load (low PRAL) diet.
1077231|NCT00620750|B1|Baseline|Extended Release Injectable Naltrexone|This was a single arm trial, with no formal control group. The treatment administered was a single 380-mg extended-release naltrexone (Vivitrol)dose injected intramuscularly into the upper, outer gluteus,alternating sides monthly. Medication injection was performed by physicians per package insert guidelines. A final Month 4 visit assessed treatment outcomes and satisfaction. Patients interested in further extended-release naltrexone treatment at study end were referred to a related 12-month extended-release naltrexone extension study, and all patients were able to continue in primary care.
1077350|NCT00620373|O3|Outcome|Both Mammography and Gamma Imaging|For this reporting arm, the interpretation and analysis was done with both mammography and gamma images together.
1079585|NCT00615108|O3|Outcome|Total|Telmisartan 40mg or 80 mg
1077232|NCT00620750|P1|Participant Flow|Extended Release Injectable Naltrexone|This was a single arm trial, with no formal control group. The treatment administered was a single 380-mg extended-release naltrexone (Vivitrol)dose injected intramuscularly into the upper, outer gluteus,alternating sides monthly. Medication injection was performed by physicians per package insert guidelines. A final Month 4 visit assessed treatment outcomes and satisfaction. Patients interested in further extended-release naltrexone treatment at study end were referred to a related 12-month extended-release naltrexone extension study, and all patients were able to continue in primary care.
1077362|NCT00620282|P2|Participant Flow|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1079141|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
1077233|NCT00620750|O1|Outcome|Extended Release Injectable Naltrexone|This was a single arm trial, with no formal control group. The treatment administered was a single 380-mg extended-release naltrexone (Vivitrol)dose injected intramuscularly into the upper, outer gluteus,alternating sides monthly. Medication injection was performed by physicians per package insert guidelines. A final Month 4 visit assessed treatment outcomes and satisfaction. Patients interested in further extended-release naltrexone treatment at study end were referred to a related 12-month extended-release naltrexone extension study, and all patients were able to continue in primary care.
1077234|NCT00620750|E1|Reported Event|Extended Release Injectable Naltrexone|This was a single arm trial, with no formal control group. The treatment administered was a single 380-mg extended-release naltrexone (Vivitrol)dose injected intramuscularly into the upper, outer gluteus,alternating sides monthly. Medication injection was performed by physicians per package insert guidelines. A final Month 4 visit assessed treatment outcomes and satisfaction. Patients interested in further extended-release naltrexone treatment at study end were referred to a related 12-month extended-release naltrexone extension study, and all patients were able to continue in primary care.
1077235|NCT00620711|B1|Baseline|Preter Infnats With HIE|"Babies that meet criteria will be offered participation in feasibility trial, there are no other arms. Criteria include Sentinel evnet , Low Apgar, pH less than 7, Neonatal encephalopathy with no other cause and need for mechanical ventialtion~Olympic Cool Cap: Olympic Cool Cap will be applied to infants 32-35 weeks gestation who meet criteria for HIE."
1077236|NCT00620711|P1|Participant Flow|Group 1 Cool- Cap Applied While Maintaining Rectal Temp|Babies that meet criteria will be offered participation in feasibility trial, there are no other arms.
1077237|NCT00620711|O1|Outcome|Group 1 Cool- Cap Applied While Maintaining Rectal Temp|Babies that meet criteria will be offered participation in feasibility trial, there are no other arms.
1077238|NCT00620711|O1|Outcome|Group 1 Cool- Cap Applied While Maintaining Rectal Temp|Babies that meet criteria will be offered participation in feasibility trial, there are no other arms.
1077239|NCT00620711|E1|Reported Event|Preterm Infants With HIE|"Babies that meet criteria will be offered participation in feasibility trial, there are no other arms.~Olympic Cool Cap: Olympic Cool Cap will be applied to infants 32-35 weeks gestation who meet criteria for HIE."
1077240|NCT00620698|B1|Baseline|ALS Patients|Patients with clinically established amyotrophic lateral sclerosis
1077241|NCT00620698|P1|Participant Flow|ALS Patients|Patients with clinically established amyotrophic lateral sclerosis
1077242|NCT00620698|O1|Outcome|ALS Patients|Patients with clinically established amyotrophic lateral sclerosis
1077243|NCT00620698|O1|Outcome|ALS Patients|Patients with clinically established amyotrophic lateral sclerosis
1077244|NCT00620698|O1|Outcome|ALS Patients|Patients with clinically established amyotrophic lateral sclerosis
1077245|NCT00620698|E1|Reported Event|ALS Patients|Patients with clinically established amyotrophic lateral sclerosis
1077246|NCT00620659|B1|Baseline|All Randomized Participants|All participants randomized in study
1077247|NCT00620659|P6|Participant Flow|Modafinil/Placebo/MK0249|"Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.~MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet."
1077248|NCT00620659|P5|Participant Flow|Placebo/MK0249/Modafinil|"Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.~MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet."
1077249|NCT00620659|P4|Participant Flow|MK0249/Modafinil/Placebo|"Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.~MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet."
1077250|NCT00620659|P3|Participant Flow|Modafinil/MK0249/Placebo|"Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.~MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet."
1077351|NCT00620373|O2|Outcome|Gamma Imaging|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
1077352|NCT00620373|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
1077353|NCT00620373|O3|Outcome|Both Mammography and Gamma Imaging|For this reporting arm, the interpretation and analysis was done with both mammography and gamma images together.
1077273|NCT00620555|O1|Outcome|Gabapentin|Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 mg/kg/day for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 mg per day. Participants aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
1077251|NCT00620659|P2|Participant Flow|Placebo/Modafinil/MK0249|"Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.~MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet."
1077252|NCT00620659|P1|Participant Flow|MK0249/Placebo/Modafinil|"Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.~MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet."
1077253|NCT00620659|O2|Outcome|MK0249 Mode Dose|"The Mode dose (the dose to which most patients were adaptively assigned) of MK0249 was 10 mg.~There were 39 participants who received MK0249 10 mg (Mode Dose) over 3 periods (14, 12, and 13 participants for Periods 1, 2, and 3 respectively)."
1077254|NCT00620659|O1|Outcome|Placebo|There were 116 participants who received placebo over 3 periods (42, 38, and 36 participants for Periods 1, 2, and 3 respectively).
1077255|NCT00620659|O2|Outcome|MK0249 Mode Dose|"The Mode dose (the dose to which most patients were adaptively assigned) of MK0249 was 10 mg.~There were 39 participants who received MK0249 10 mg (Mode Dose) over 3 periods (14, 12, and 13 participants for Periods 1, 2, and 3 respectively)."
1077256|NCT00620659|O1|Outcome|Placebo|There were 116 participants who received placebo over 3 periods (42, 38, and 36 participants for Periods 1, 2, and 3 respectively).
1077257|NCT00620659|O2|Outcome|Modafinil 200 mg|There were 106 participants who received Modafinil 200 mg over 3 periods (40, 36, and 30 participants for Periods 1, 2, and 3 respectively).
1077258|NCT00620659|O1|Outcome|MK0249 Top 2 Doses Pooled|"The top 2 doses (the two doses to which most patients were adaptively assigned) were 10 mg and 12 mg.~There were 74 participants who received MK0249 10 and 12 mg over 3 periods (25, 22, and 27 participants for Periods 1, 2, and 3 respectively)."
1077259|NCT00620659|O2|Outcome|Modafinil 200 mg|There were 106 participants who received Modafinil 200 mg over 3 periods (40, 36, and 30 participants for Periods 1, 2, and 3 respectively).
1077260|NCT00620659|O1|Outcome|MK0249 Mode Dose|"The Mode dose (the dose to which most patients were adaptively assigned) of MK0249 was 10 mg~There were 39 participants who received MK0249 10 mg (Mode Dose) over 3 periods (14, 12, and 13 participants for Periods 1, 2, and 3 respectively)."
1077261|NCT00620659|O2|Outcome|MK0249 Mode Dose|"The Mode dose (the dose to which most patients were adaptively assigned) of MK0249 was 10 mg.~There were 39 participants who received MK0249 10 mg (Mode Dose) over 3 periods (14, 12, and 13 participants for Periods 1, 2, and 3 respectively)."
1077262|NCT00620659|O1|Outcome|Placebo|There were 116 participants who received placebo over 3 periods (42, 38, and 36 participants for Periods 1, 2, and 3 respectively).
1077263|NCT00620659|E6|Reported Event|Modafinil|Modafinil was provided as 100 mg tablets.
1077264|NCT00620659|E5|Reported Event|MK0249 12 mg|MK0249 was provided as 1 mg and 5 mg tablets.
1077265|NCT00620659|E4|Reported Event|MK0249 10 mg|MK0249 was provided as 1 mg and 5 mg tablets.
1077266|NCT00620659|E3|Reported Event|MK0249 8 mg|MK0249 was provided as 1 mg and 5 mg tablets.
1077267|NCT00620659|E2|Reported Event|MK0249 5 mg|MK0249 was provided as 1 mg and 5 mg tablets.
1077268|NCT00620659|E1|Reported Event|Placebo|Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet.
1077269|NCT00620555|B1|Baseline|Gabapentin|Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 mg/kg/day for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 mg per day. Participants aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
1077270|NCT00620555|P1|Participant Flow|Gabapentin|Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 mg/kg/day for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 mg per day. Participants aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
1077271|NCT00620555|O1|Outcome|Gabapentin|Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 mg/kg/day for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 mg per day. Participants aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
1077272|NCT00620555|O1|Outcome|Gabapentin|Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 mg/kg/day for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 mg per day. Participants aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
1077354|NCT00620373|O2|Outcome|Gamma Imaging|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
1077274|NCT00620555|O1|Outcome|Gabapentin|Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 mg/kg/day for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 mg per day. Participants aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
1077275|NCT00620555|E1|Reported Event|Gabapentin|Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 mg/kg/day for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 mg per day. Participants aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
1077276|NCT00620542|B3|Baseline|Total|Total of all reporting groups
1077277|NCT00620542|B2|Baseline|Atorvastatin 80 mg|2 years
1077278|NCT00620542|B1|Baseline|Rosuvastatin 40 mg|2 years
1077279|NCT00620542|P4|Participant Flow|Atorvastatin 80 mg|2 year core study
1077280|NCT00620542|P3|Participant Flow|Rosuvastatin 40 mg|2 year core study
1077281|NCT00620542|P2|Participant Flow|Atorvastatin 40 mg|2 week run-in period
1077282|NCT00620542|P1|Participant Flow|Rosuvastatin 20 mg|2 week run-in period
1077283|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
1077284|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
1077285|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
1077286|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
1077287|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
1077288|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
1077289|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
1077290|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
1077291|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
1077292|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
1077293|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
1077294|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
1077295|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
1077296|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
1077297|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
1077298|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
1077299|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
1077300|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
1077301|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
1077302|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
1077303|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
1077304|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
1077305|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
1077306|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
1077307|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
1077308|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
1077309|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
1077310|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
1077311|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
1077312|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
1077313|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
1077314|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
1077315|NCT00620542|E4|Reported Event|Atorvastatin 80 mg|2 year core study
1077316|NCT00620542|E3|Reported Event|Rosuvastatin 40 mg|2 year core study
1077317|NCT00620542|E2|Reported Event|Atorvastatin 40 mg|2 week run-in period
1077318|NCT00620542|E1|Reported Event|Rosuvastatin 20 mg|2 week run-in period
1077319|NCT00620464|B3|Baseline|Total|Total of all reporting groups
1077355|NCT00620373|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
1077356|NCT00620373|E1|Reported Event|Mammography and Molecular Breast Imaging|Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ)(20-mCi) Technetium (99mTc) sestamibi injection.
1077320|NCT00620464|B2|Baseline|Implanon (Imp)|"Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane.~The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year."
1077321|NCT00620464|B1|Baseline|Radiopaque Implanon (ro Imp)|The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.
1077322|NCT00620464|P2|Participant Flow|Implanon (Imp)|"Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane.~The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year."
1077323|NCT00620464|P1|Participant Flow|Radiopaque Implanon (ro Imp)|The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.
1077324|NCT00620464|O2|Outcome|Implanon (Imp)|"Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane.~The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year."
1077325|NCT00620464|O1|Outcome|Radiopaque Implanon (ro Imp)|The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.
1077326|NCT00620464|O2|Outcome|Implanon (Imp)|"Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane.~The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year."
1077327|NCT00620464|O1|Outcome|Radiopaque Implanon (ro Imp)|The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.
1077328|NCT00620464|E2|Reported Event|Radiopaque Implanon|The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.
1077329|NCT00620464|E1|Reported Event|Implanon|"Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane.~The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year."
1077330|NCT00620425|B1|Baseline|All Participants|Every participant received SUMAVEL DosePro at time 0, 1 and 25 hrs. Every participant was monitored for the incidence and persistence of bleeding, bruising, swelling and erythema.
1077331|NCT00620425|P1|Participant Flow|All Participants|Every participant received SUMAVEL DosePro at time 0, 1 and 25 hrs. Every participant was monitored for the incidence and persistence of bleeding, bruising, swelling and erythema.
1077332|NCT00620425|O8|Outcome|72 hr Post-dose|Only 3 subjects were required to return on Day 4. Day 4 assessments included a 72 hour assessment for the first and second injections and a 48 hour assessment for the third injection.
1077333|NCT00620425|O7|Outcome|48 hr Post-dose|These are the reactions relative to each injection (total of 3 injections in 18 participants).
1077334|NCT00620425|O6|Outcome|24 hr Post-dose|These are the reactions relative to each injection (total of 3 injections in 18 participants).
1077335|NCT00620425|O5|Outcome|8 hr Post-dose|These are the reactions relative to each injection (total of 3 injections in 18 participants).
1077336|NCT00620425|O4|Outcome|4 hr Post-dose|These are the reactions relative to each injection (total of 3 injections in 18 participants).
1077337|NCT00620425|O3|Outcome|1 hr Post-dose|These are the reactions relative to each injection (total of 3 injections in 18 participants).
1077338|NCT00620425|O2|Outcome|All Participants Immediately Post-dose|These are the reactions relative to each injection (total of 3 injections in 18 participants).
1077339|NCT00620425|O1|Outcome|All Participants at -15 Min Pre-dose|Every participant received SUMAVEL DosePro at time 0, 1 and 25 hrs. Every participant was monitored for the incidence and persistence of bleeding, bruising, swelling and erythema.
1077340|NCT00620425|E1|Reported Event|All Participants|Every participant received SUMAVEL DosePro at time 0, 1 and 25 hrs. Every participant was monitored for the incidence and persistence of bleeding, bruising, swelling and erythema.
1077341|NCT00620373|B1|Baseline|Mammography and Molecular Breast Imaging|Participants underwent conventional mammography and molecular breast imaging after a 740-mBQ (20-mCi) Technetium (99mTc) sestamibi injection.
1077342|NCT00620373|P1|Participant Flow|Mammography and Molecular Breast Imaging|Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ)(20-mCi) Technetium (99mTc) sestamibi injection.
1077343|NCT00620373|O3|Outcome|Both Mammography and Gamma Imaging|For this reporting arm, the interpretation and analysis was done with both mammography and gamma images together.
1077344|NCT00620373|O2|Outcome|Gamma Imaging|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
1077345|NCT00620373|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
1077346|NCT00620373|O3|Outcome|Both Mammography and Gamma Imaging|For this reporting arm, the interpretation and analysis was done with both mammography and gamma images together.
1077347|NCT00620373|O2|Outcome|Gamma Imaging|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
1077348|NCT00620373|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
1077349|NCT00620373|O1|Outcome|Mammography and Molecular Breast Imaging|Participants underwent conventional mammography and molecular breast imaging after a 740-mBQ (20-mCi) Technetium (99mTc) sestamibi injection.
1077358|NCT00620282|B3|Baseline|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
1077359|NCT00620282|B2|Baseline|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1077360|NCT00620282|B1|Baseline|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1077361|NCT00620282|P3|Participant Flow|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
1079142|NCT00616655|O1|Outcome|Placebo Arm|Placebo
1077363|NCT00620282|P1|Participant Flow|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1077364|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
1077365|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1077366|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1077367|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
1077368|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1077369|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1077370|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
1077371|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1077372|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1077373|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
1077374|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1077375|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1077376|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
1077377|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1077378|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1077379|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
1077380|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1077381|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1077382|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
1077383|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1077384|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1077385|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
1077386|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1077387|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1077388|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
1077389|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1077390|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1077391|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
1077392|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1077393|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1077394|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
1077395|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1077396|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1077397|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
1077398|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1077399|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1077400|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
1077401|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1077402|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1078846|NCT00617240|B1|Baseline|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
1077403|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
1077404|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1077405|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1077406|NCT00620282|E3|Reported Event|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
1077407|NCT00620282|E2|Reported Event|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1077408|NCT00620282|E1|Reported Event|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
1077409|NCT00620074|B1|Baseline|Anidulalfungin and Voriconazole|"Voriconazole: subjects with creatinine clearance at least 50 milliliters per minute (ml/min) will receive initial treatment with intravenous (IV) (loading dose of 6 milligrams per kilogram [mg/kg] every 12 hours [Q12h]) followed by maintenance dose of 4 mg/kg Q12h or oral (PO) (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h). Subjects with creatinine clearance <50 ml/min will receive oral Voriconazole (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h).~Anidulafungin: loading dose of 200 mg once daily (QD) followed by maintenance dose of 100 mg QD for up to a total of 28 days therapy.~Subjects remain on combination therapy for minimum of 14 days and a maximum of 28 days; after combination therapy complete, subjects may remain on a maintenance dose of Voriconazole monotherapy until Day 42."
1077410|NCT00620074|P1|Participant Flow|Anidulalfungin and Voriconazole|"Voriconazole: subjects with creatinine clearance at least 50 milliliters per minute (ml/min) will receive initial treatment with intravenous (IV) (loading dose of 6 milligrams per kilogram [mg/kg] every 12 hours [Q12h]) followed by maintenance dose of 4 mg/kg Q12h or oral (PO) (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h). Subjects with creatinine clearance <50 ml/min will receive oral Voriconazole (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h).~Anidulafungin: loading dose of 200 mg once daily (QD) followed by maintenance dose of 100 mg QD for up to a total of 28 days therapy.~Subjects remain on combination therapy for minimum of 14 days and a maximum of 28 days; after combination therapy complete, subjects may remain on a maintenance dose of Voriconazole monotherapy until Day 42."
1077411|NCT00620074|O1|Outcome|Anidulalfungin and Voriconazole|Anidulafungin and voriconazole in combination followed by monotherapy.
1077412|NCT00620074|O1|Outcome|Anidulalfungin and Voriconazole|Anidulafungin and voriconazole in combination followed by monotherapy.
1077413|NCT00620074|O1|Outcome|Anidulalfungin and Voriconazole|Anidulafungin and voriconazole in combination followed by monotherapy.
1077414|NCT00620074|O1|Outcome|Anidulalfungin and Voriconazole|Anidulafungin and voriconazole in combination followed by monotherapy.
1077415|NCT00620074|O1|Outcome|Anidulalfungin and Voriconazole|Anidulafungin and voriconazole in combination followed by monotherapy.
1077416|NCT00620074|E1|Reported Event|Anidulalfungin and Voriconazole|"Voriconazole: subjects with creatinine clearance at least 50 milliliters per minute (ml/min) will receive initial treatment with intravenous (IV) (loading dose of 6 milligrams per kilogram [mg/kg] every 12 hours [Q12h]) followed by maintenance dose of 4 mg/kg Q12h or oral (PO) (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h). Subjects with creatinine clearance <50 ml/min will receive oral Voriconazole (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h).~Anidulafungin: loading dose of 200 mg once daily (QD) followed by maintenance dose of 100 mg QD for up to a total of 28 days therapy.~Subjects remain on combination therapy for minimum of 14 days and a maximum of 28 days; after combination therapy complete, subjects may remain on a maintenance dose of Voriconazole monotherapy until Day 42."
1077417|NCT00620035|B1|Baseline|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
1077418|NCT00620035|P1|Participant Flow|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
1077419|NCT00620035|O1|Outcome|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
1077420|NCT00620035|O1|Outcome|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
1077483|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077530|NCT00619957|E4|Reported Event|Risedronate Year 4|Risedronate 35 mg tablet once weekly Years 1 thru 4
1077421|NCT00620035|O1|Outcome|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
1077422|NCT00620035|O1|Outcome|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
1077423|NCT00620035|O1|Outcome|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
1077424|NCT00620035|O1|Outcome|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
1077425|NCT00620035|O1|Outcome|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
1077426|NCT00620035|E1|Reported Event|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
1077427|NCT00620022|B1|Baseline|Entire Study Population|The entire study population includes the group of patients who received indacaterol 300 μg in the first treatment period followed by placebo in the second treatment period and the group of patients who received placebo in the first treatment period followed by indacaterol 300 μg in the second treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1077428|NCT00620022|P2|Participant Flow|Placebo Followed by Indacaterol 300 μg|Patients first received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received indacaterol 300 μg delivered od via a SDDPI in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1077429|NCT00620022|P1|Participant Flow|Indacaterol 300 μg Followed by Placebo|Patients first received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received placebo delivered od via a SDDPI in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1077430|NCT00620022|O2|Outcome|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1077431|NCT00620022|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1077432|NCT00620022|O2|Outcome|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1077433|NCT00620022|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1077529|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077434|NCT00620022|E2|Reported Event|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1077486|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077487|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077435|NCT00620022|E1|Reported Event|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1077436|NCT00619970|B4|Baseline|Total|Total of all reporting groups
1077437|NCT00619970|B3|Baseline|Children Receiving Placebo|1/3 patients with CAP
1077438|NCT00619970|B2|Baseline|Children Receiving Rifaximin|2/3 Patients with CAP
1077439|NCT00619970|B1|Baseline|Healthy Control|Healthy controls
1077440|NCT00619970|P3|Participant Flow|Children Receiving Placebo|1/3 patients with CAP
1077441|NCT00619970|P2|Participant Flow|Children Receiving Rifaximin|2/3 Patients with CAP
1077442|NCT00619970|P1|Participant Flow|Healthy Control|Healthy controls
1077443|NCT00619970|O2|Outcome|Children Receiving Placebo|1/3 patients with CAP
1077444|NCT00619970|O1|Outcome|Children Receiving Rifaximin|2/3 Patients with CAP
1077445|NCT00619970|O3|Outcome|Children Receiving Placebo|1/3 patients with CAP
1077446|NCT00619970|O2|Outcome|Children Receiving Rifaximin|2/3 Patients with CAP
1077447|NCT00619970|O1|Outcome|Healthy Control|Healthy controls
1077448|NCT00619970|E3|Reported Event|Children Receiving Placebo|1/3 patients with CAP
1077449|NCT00619970|E2|Reported Event|Children Receiving Rifaximin|2/3 Patients with CAP
1077450|NCT00619970|E1|Reported Event|Healthy Control|Healthy controls
1077451|NCT00619957|B3|Baseline|Total|Total of all reporting groups
1077452|NCT00619957|B2|Baseline|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077453|NCT00619957|B1|Baseline|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077454|NCT00619957|P2|Participant Flow|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077455|NCT00619957|P1|Participant Flow|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077456|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077457|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077458|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077459|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077460|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077461|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077462|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077463|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077464|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077465|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077466|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077467|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077468|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077469|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077470|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077471|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077472|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077473|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077474|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077475|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077476|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077477|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077478|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077479|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077480|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077481|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077482|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077484|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077485|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077488|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077489|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077490|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077491|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077492|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077493|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077494|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077495|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077496|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077497|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077498|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077499|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077500|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077501|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077502|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077503|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077504|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077505|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077506|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077507|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077508|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077509|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077510|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077511|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077512|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077513|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077514|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077515|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077516|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077517|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077518|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077519|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077520|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077521|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077522|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077523|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077524|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077525|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077526|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077527|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
1077528|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
1077531|NCT00619957|E3|Reported Event|Placebo-Risedronate Year 4|Placebo once weekly Years 1 & 2 followed by risedronate 35 mg once weekly Years 3 & 4
1077532|NCT00619957|E2|Reported Event|Risedronate Year 2|Risedronate 35 mg tablet once weekly Years 1 & 2
1077533|NCT00619957|E1|Reported Event|Placebo Year 2|Placebo tablet once weekly Years 1 & 2
1077534|NCT00619918|B3|Baseline|Total|Total of all reporting groups
1077535|NCT00619918|B2|Baseline|Normal Saline|"0.9% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
1077536|NCT00619918|B1|Baseline|Hypertonic Saline|"3% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
1077537|NCT00619918|P2|Participant Flow|Normal Saline|"0.9% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
1077538|NCT00619918|P1|Participant Flow|Hypertonic Saline|"3% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
1077539|NCT00619918|O2|Outcome|Normal Saline|"0.9% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
1077540|NCT00619918|O1|Outcome|Hypertonic Saline|"3% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
1077541|NCT00619918|O2|Outcome|Normal Saline|"0.9% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
1077542|NCT00619918|O1|Outcome|Hypertonic Saline|"3% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
1077543|NCT00619918|E2|Reported Event|Normal Saline|"0.9% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
1077544|NCT00619918|E1|Reported Event|Hypertonic Saline|"3% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
1077545|NCT00619892|B3|Baseline|Total|Total of all reporting groups
1077546|NCT00619892|B2|Baseline|Placebo|Placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.
1077547|NCT00619892|B1|Baseline|Quetiapine|Quetiapine SR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
1077548|NCT00619892|P2|Participant Flow|Placebo|placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.
1077549|NCT00619892|P1|Participant Flow|Quetiapine SR|quetiapine SR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
1077550|NCT00619892|O2|Outcome|Placebo|"Subjects received identical-appearing placebo tablets provided by Astra Zeneca (50, 200, and 300 mg designations).~placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication."
1077551|NCT00619892|O1|Outcome|Quetiapine XR|"Our target daily dose for quetiapine XR was 200 mg/day. The detailed quetiapine XR dosing guidelines were as follows: 50 mg 1 tab po at HS × 3 days, then, if 50 mg tolerated, increase to 50 mg 2 tabs at HS × 4 days; at the beginning of week 2, if the last dose was tolerated increase to 50 mg 3 tabs at HS × 3 days, then, if 150 mg tolerated, increase to 4 tabs at HS; at the beginning of week 3, if no efficacy & the 200 mg dose was well tolerated, increase to one 300 mg tab at HS-otherwise remain at 200 mg one tab at HS; at week 4 if still no improvement, & 300 mg was tolerable, increase to 200 mg tablet 2 at HS. From the beginning of week 5 to the end of the trial, quetiapine XR doses were held. We used quetiapine XR tablets provided by Astra Zeneca (50, 200, and 300 mg designations).~quetiapine XR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg."
1077552|NCT00619892|O2|Outcome|Placebo|placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.
1077553|NCT00619892|O1|Outcome|Quetiapine SR|quetiapine SR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
1077554|NCT00619892|E2|Reported Event|Placebo Group|placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.
1077555|NCT00619892|E1|Reported Event|Quietapine Group|quetiapine SR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
1077556|NCT00619827|B3|Baseline|Total|Total of all reporting groups
1077557|NCT00619827|B2|Baseline|Placebo|Placebo tablet
1077558|NCT00619827|B1|Baseline|300 IR|300 IR grass pollen allergen extract tablet
1077559|NCT00619827|P2|Participant Flow|Placebo|Placebo tablet
1077560|NCT00619827|P1|Participant Flow|300 IR|300 IR grass pollen allergen extract tablet
1077561|NCT00619827|O2|Outcome|Placebo|Placebo tablet
1077562|NCT00619827|O1|Outcome|300 IR|300 IR grass pollen allergen extract tablet
1077563|NCT00619827|E2|Reported Event|Placebo|Placebo tablet
1077564|NCT00619827|E1|Reported Event|300 IR|300 IR grass pollen allergen extract tablet
1077565|NCT00619801|B3|Baseline|Total|Total of all reporting groups
1077566|NCT00619801|B2|Baseline|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1077567|NCT00619801|B1|Baseline|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1077568|NCT00619801|P2|Participant Flow|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1077569|NCT00619801|P1|Participant Flow|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1077570|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1077571|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1077572|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1077573|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1077574|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1077575|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1077576|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1077577|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1077578|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1077579|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1077580|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1077581|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1077582|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1077583|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1077584|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1077585|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1077586|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1077587|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1077588|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1077589|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1077590|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1077591|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1077592|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1079135|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
1077593|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1077594|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1077595|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1077596|NCT00619801|E2|Reported Event|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1077597|NCT00619801|E1|Reported Event|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
1077598|NCT00619762|B1|Baseline|LTN - Porcine Acellulare Dermal Matrix in Breast Recon|This was a single arm sudy without a control arm LTM used to reinforce weak tissue in breast reconstruction surgery
1077599|NCT00619762|P1|Participant Flow|LTM - Porcine Acellular Dermal Matrix in Breast Reconstruct|"This was a single arm sudy without a control arm~Use of LTM to reinforce weak tissue in two-stage (expander then permanent implant) immediate post-mastectomy breast reconstruction."
1077600|NCT00619762|O1|Outcome|Treatment Arm|All implanted patients in the study, that is 29 breasts in 17 patients
1077601|NCT00619762|O1|Outcome|Treatment Arm|all available patients/breasts who completed specified visit
1077602|NCT00619762|E1|Reported Event|Treatment Arm|All implanted patients in the study, that is 29 breasts in 17 patients
1077603|NCT00619684|B1|Baseline|Treatment (Lenalidomide)|"Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given PO"
1077604|NCT00619684|P1|Participant Flow|Treatment (Lenalidomide)|"Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given PO"
1077605|NCT00619684|O1|Outcome|Treatment (Lenalidomide)|"Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given PO"
1077606|NCT00619684|O1|Outcome|Treatment (Lenalidomide)|"Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given PO"
1077607|NCT00619684|O1|Outcome|Treatment (Lenalidomide)|"Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given PO"
1077608|NCT00619684|O1|Outcome|Treatment (Lenalidomide)|"Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given PO"
1077609|NCT00619684|O1|Outcome|Treatment (Lenalidomide)|"Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given PO"
1077610|NCT00619684|O1|Outcome|Treatment (Lenalidomide)|"Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given PO"
1077611|NCT00619684|E1|Reported Event|Treatment (Lenalidomide)|"Patients receive lenalidomide PO on days 1-21. Courses repeat every 28 days for 2 years or longer in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given PO"
1077612|NCT00619645|B1|Baseline|RIST for Heme Malignancies|"Busulfan 3.3 mg/kg over 3 hours on day –6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day –6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy~busulfan~cyclosporine~fludarabine phosphate~mycophenolate mofetil~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
1077613|NCT00619645|P1|Participant Flow|RIST for Heme Malignancies|"Busulfan 3.3 mg/kg over 3 hours on day –6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day –6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy~busulfan~cyclosporine~fludarabine phosphate~mycophenolate mofetil~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
1077614|NCT00619645|O1|Outcome|RIST for Heme Malignancies|"Busulfan 3.3 mg/kg over 3 hours on day –6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day –6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy~busulfan~cyclosporine~fludarabine phosphate~mycophenolate mofetil~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
1077615|NCT00619645|O1|Outcome|RIST for Heme Malignancies|"Busulfan 3.3 mg/kg over 3 hours on day –6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day –6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy~busulfan~cyclosporine~fludarabine phosphate~mycophenolate mofetil~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
1077616|NCT00619645|O1|Outcome|RIST for Heme Malignancies|"Busulfan 3.3 mg/kg over 3 hours on day –6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day –6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy~busulfan~cyclosporine~fludarabine phosphate~mycophenolate mofetil~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
1077617|NCT00619645|E1|Reported Event|RIST for Heme Malignancies|"Busulfan 3.3 mg/kg over 3 hours on day –6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day –6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy~busulfan~cyclosporine~fludarabine phosphate~mycophenolate mofetil~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
1077618|NCT00619619|B9|Baseline|Total|Total of all reporting groups
1077673|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
1077619|NCT00619619|B8|Baseline|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
1077620|NCT00619619|B7|Baseline|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
1077621|NCT00619619|B6|Baseline|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
1077622|NCT00619619|B5|Baseline|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
1077623|NCT00619619|B4|Baseline|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
1077624|NCT00619619|B3|Baseline|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
1077625|NCT00619619|B2|Baseline|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
1077626|NCT00619619|B1|Baseline|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
1077627|NCT00619619|P8|Participant Flow|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
1077628|NCT00619619|P7|Participant Flow|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
1077629|NCT00619619|P6|Participant Flow|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
1077630|NCT00619619|P5|Participant Flow|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
1077631|NCT00619619|P4|Participant Flow|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
1077632|NCT00619619|P3|Participant Flow|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
1077633|NCT00619619|P2|Participant Flow|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
1077634|NCT00619619|P1|Participant Flow|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
1077635|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
1077636|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
1077637|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
1077638|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
1077639|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
1077640|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
1077641|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
1077642|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
1077643|NCT00619619|O1|Outcome|Desvenlafaxine - Combined Children and Adolescent Cohorts|Desvenlafaxine sustained release tablets for 10 mg, 25 mg, 50 mg, and 100 mg Children cohort dose levels and Desvenlafaxine sustained release tablets for 25 mg, 50 mg, 100 mg, and 200 mg Adolescent cohort dose levels.
1077644|NCT00619619|O2|Outcome|Desvenlafaxine – Combined Adolescent Cohorts|Desvenlafaxine sustained release tablets for 25 mg, 50 mg, 100 mg, and 200 mg Adolescent cohort dose levels.
1077645|NCT00619619|O1|Outcome|Desvenlafaxine – Combined Children Cohorts|Desvenlafaxine sustained release tablets for 10 mg, 25 mg, 50 mg, and 100 mg Children cohort dose levels.
1077767|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
1077646|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
1077647|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
1077648|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
1077649|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
1077650|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
1077651|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
1077652|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
1077653|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
1077654|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
1077655|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
1077656|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
1077657|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
1077658|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
1077659|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
1077660|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
1077661|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
1077662|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
1077663|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
1077664|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
1077665|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
1077666|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
1077667|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
1077668|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
1077669|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
1077670|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
1077671|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
1077672|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
1077674|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
1077675|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
1077676|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
1077677|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
1077678|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
1077679|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
1077680|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
1077681|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
1077682|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
1077683|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
1077684|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
1077685|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
1077686|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
1077687|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
1077688|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
1077689|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
1077690|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
1077691|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
1077692|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
1077693|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
1077694|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
1077695|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
1077696|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
1077697|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
1077698|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
1077699|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
1077700|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
1077701|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
1077702|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
1077703|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
1077704|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
1077705|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
1077706|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
1077707|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
1077708|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
1077709|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
1077710|NCT00619619|E8|Reported Event|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
1077711|NCT00619619|E7|Reported Event|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
1077712|NCT00619619|E6|Reported Event|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
1077713|NCT00619619|E5|Reported Event|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
1077714|NCT00619619|E4|Reported Event|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
1077715|NCT00619619|E3|Reported Event|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
1077716|NCT00619619|E2|Reported Event|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
1077717|NCT00619619|E1|Reported Event|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
1077718|NCT00619502|B3|Baseline|Total|Total of all reporting groups
1077719|NCT00619502|B2|Baseline|Pentaxim™ + Engerix B™|All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study.
1077720|NCT00619502|B1|Baseline|DTaP-IPV-HepB-PRP~T|All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study.
1077721|NCT00619502|P2|Participant Flow|Pentaxim™ + Engerix B™|All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study.
1077722|NCT00619502|P1|Participant Flow|DTaP-IPV-HepB-PRP~T|All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study.
1077723|NCT00619502|O2|Outcome|Pentaxim™ + Engerix B™|All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP-T at 15 to 18 months of age in the present study.
1077724|NCT00619502|O1|Outcome|DTaP-IPV-HepB-PRP-T|All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP-T at 15 to 18 months of age in the present study.
1077725|NCT00619502|O2|Outcome|Pentaxim™ + Engerix B™|All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study.
1077726|NCT00619502|O1|Outcome|DTaP-IPV-HepB-PRP~T|All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study.
1077727|NCT00619502|O2|Outcome|Pentaxim™ + Engerix B™|All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study.
1077813|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
1077728|NCT00619502|O1|Outcome|DTaP-IPV-HepB-PRP~T|All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study.
1077729|NCT00619502|E2|Reported Event|Pentaxim™ + Engerix B™|All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study.
1077730|NCT00619502|E1|Reported Event|DTaP-IPV-HepB-PRP~T|All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study.
1077731|NCT00619489|B3|Baseline|Total|Total of all reporting groups
1077732|NCT00619489|B2|Baseline|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
1077733|NCT00619489|B1|Baseline|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
1077734|NCT00619489|P2|Participant Flow|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
1077735|NCT00619489|P1|Participant Flow|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
1077736|NCT00619489|O2|Outcome|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
1077737|NCT00619489|O1|Outcome|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
1077738|NCT00619489|O2|Outcome|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
1077739|NCT00619489|O1|Outcome|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
1077740|NCT00619489|O2|Outcome|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
1077741|NCT00619489|O1|Outcome|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
1077742|NCT00619489|O2|Outcome|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
1077743|NCT00619489|O1|Outcome|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
1077744|NCT00619489|O2|Outcome|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
1077745|NCT00619489|O1|Outcome|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
1077746|NCT00619489|O2|Outcome|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
1077747|NCT00619489|O1|Outcome|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
1077748|NCT00619489|O2|Outcome|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
1077749|NCT00619489|O1|Outcome|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
1077750|NCT00619489|E2|Reported Event|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
1077751|NCT00619489|E1|Reported Event|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
1077752|NCT00619476|B5|Baseline|Total|Total of all reporting groups
1077753|NCT00619476|B4|Baseline|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
1077754|NCT00619476|B3|Baseline|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
1077755|NCT00619476|B2|Baseline|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
1077756|NCT00619476|B1|Baseline|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
1077757|NCT00619476|P4|Participant Flow|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
1077758|NCT00619476|P3|Participant Flow|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
1077759|NCT00619476|P2|Participant Flow|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
1077760|NCT00619476|P1|Participant Flow|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
1077761|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
1077762|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
1077763|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
1077764|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
1077765|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
1077766|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
1077922|NCT00619190|B3|Baseline|Total|Total of all reporting groups
1077768|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
1077769|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
1077770|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
1077771|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
1077772|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
1077773|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
1077774|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
1077775|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
1077776|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
1077777|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
1077778|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
1077779|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
1077780|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
1077781|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
1077782|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
1077783|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
1077784|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
1077785|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
1077786|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
1077787|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
1077788|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
1077789|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
1077790|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
1077791|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
1077792|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
1077793|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
1077794|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
1077795|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
1077796|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
1077797|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
1077798|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
1077799|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
1077800|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
1077801|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
1077802|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
1077803|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
1077804|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
1077805|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
1077806|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
1077807|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
1077808|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
1077809|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
1077810|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
1077811|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
1077812|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
1077814|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
1077815|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
1077816|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
1077817|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
1077818|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
1077819|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
1077820|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
1077821|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
1077822|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
1077823|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
1077824|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
1077825|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
1077826|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
1077827|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
1077828|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
1077829|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
1077830|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
1077831|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
1077832|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
1077833|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
1077834|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
1077835|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
1077836|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
1077837|NCT00619476|E4|Reported Event|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
1077838|NCT00619476|E3|Reported Event|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
1077839|NCT00619476|E2|Reported Event|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
1077840|NCT00619476|E1|Reported Event|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
1077841|NCT00619385|B4|Baseline|Total|Total of all reporting groups
1077842|NCT00619385|B3|Baseline|Proellex 200 mg|"Proellex 200 mg daily for 7 days~Proellex: Proellex 25 mg capsules 100 mg, 150 mg or 200mg daily for 7 days"
1077843|NCT00619385|B2|Baseline|Proellex 150 mg|"Proellex 150 mg daily for 7 days~Proellex: Proellex 25 mg capsules 100 mg, 150 mg or 200mg daily for 7 days"
1077844|NCT00619385|B1|Baseline|Proellex 100 mg|"Proellex 100 mg daily for 7 days~Proellex: Proellex 25 mg capsules 100 mg, 150 mg or 200mg daily for 7 days"
1077845|NCT00619385|P3|Participant Flow|Proellex 200 mg|Proellex 200 mg daily for 7 days
1077846|NCT00619385|P2|Participant Flow|Proellex 150 mg|Proellex 150 mg daily for 7 days
1077847|NCT00619385|P1|Participant Flow|Proellex 100 mg|Proellex 100 mg daily for 7 days
1077848|NCT00619385|O4|Outcome|Proellex 200 mg Vials|Proellex 200 mg vials daily for 7 days
1077849|NCT00619385|O3|Outcome|Proellex 200 mg Caps|Proellex 200 mg capsules daily for 7 days
1077850|NCT00619385|O2|Outcome|Proellex 150 mg|Proellex 150 mg daily for 7 days
1077851|NCT00619385|O1|Outcome|Proellex 100 mg|Proellex 100 mg daily for 7 days
1077852|NCT00619385|O4|Outcome|Proellex 200 mg Vials|Proellex 200 mg daily for 7 days vials
1077853|NCT00619385|O3|Outcome|Proellex 200 mg Caps|Proellex 200 mg daily for 7 days capsules
1077854|NCT00619385|O2|Outcome|Proellex 150 mg|Proellex 150 mg daily for 7 days
1077855|NCT00619385|O1|Outcome|Proellex 100 mg|Proellex 100 mg daily for 7 days
1077856|NCT00619385|E3|Reported Event|Proellex 200 mg|Proellex 200 mg daily for 7 days
1077857|NCT00619385|E2|Reported Event|Proellex 150 mg|Proellex 150 mg daily for 7 days
1077858|NCT00619385|E1|Reported Event|Proellex 100 mg|Proellex 100 mg daily for 7 days
1077859|NCT00619359|B3|Baseline|Total|Total of all reporting groups
1077860|NCT00619359|B2|Baseline|Aprepitant|Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.
1077861|NCT00619359|B1|Baseline|Fosaprepitant|Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.
1077862|NCT00619359|P2|Participant Flow|Aprepitant|Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.
1079136|NCT00616655|O1|Outcome|Placebo Arm|Placebo
1077863|NCT00619359|P1|Participant Flow|Fosaprepitant|Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.
1077864|NCT00619359|O2|Outcome|Aprepitant|Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.
1077925|NCT00619190|P2|Participant Flow|no Medication Control|group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial.
1077865|NCT00619359|O1|Outcome|Fosaprepitant|Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.
1077866|NCT00619359|O2|Outcome|Aprepitant|Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.
1077867|NCT00619359|O1|Outcome|Fosaprepitant|Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.
1077868|NCT00619359|O2|Outcome|Aprepitant|Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.
1077869|NCT00619359|O1|Outcome|Fosaprepitant|Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.
1077870|NCT00619359|E2|Reported Event|Aprepitant|"Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.~6 patients from the aprepitant regimen were randomized to the study, but discontinued before receiving study drug. These patients were excluded from the Adverse Event tables."
1077871|NCT00619359|E1|Reported Event|Fosaprepitant|"Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.~4 patients from the fosaprepitant regimen were randomized to the study, but discontinued before receiving study drug. These patients were excluded from the Adverse Event tables."
1077872|NCT00619307|B3|Baseline|Total|Total of all reporting groups
1077873|NCT00619307|B2|Baseline|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
1077874|NCT00619307|B1|Baseline|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.~Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
1077875|NCT00619307|P2|Participant Flow|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
1077876|NCT00619307|P1|Participant Flow|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.~Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
1077877|NCT00619307|O2|Outcome|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
1077878|NCT00619307|O1|Outcome|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.~Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
1077879|NCT00619307|O2|Outcome|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
1077880|NCT00619307|O1|Outcome|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.~Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
1077923|NCT00619190|B2|Baseline|no Medication Control|group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. They may receive behavioral interventions
1077924|NCT00619190|B1|Baseline|Open Aripipraprazole|Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg
1077926|NCT00619190|P1|Participant Flow|Open Aripipraprazole|Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg
1077927|NCT00619190|O2|Outcome|no Medication Control|group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. They may receive behavioral interventions
1077928|NCT00619190|O1|Outcome|Open Aripipraprazole|Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg
1077881|NCT00619307|O2|Outcome|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
1077882|NCT00619307|O1|Outcome|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.~Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
1077883|NCT00619307|O2|Outcome|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
1077884|NCT00619307|O1|Outcome|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.~Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
1077885|NCT00619307|O2|Outcome|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
1077886|NCT00619307|O1|Outcome|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.~Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
1077887|NCT00619307|E2|Reported Event|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
1077888|NCT00619307|E1|Reported Event|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.~Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
1077889|NCT00619242|B1|Baseline|Sorafenib|
1077890|NCT00619242|P1|Participant Flow|Sorafenib|Sorafenib 400mg BID
1077891|NCT00619242|O1|Outcome|Sorafenib|
1077892|NCT00619242|E1|Reported Event|Sorafenib|
1077893|NCT00619229|B3|Baseline|Total|Total of all reporting groups
1077894|NCT00619229|B2|Baseline|Placebo|Placebo i.v. for 15 days
1077895|NCT00619229|B1|Baseline|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
1077896|NCT00619229|P2|Participant Flow|Placebo|Placebo i.v. for 15 days
1077897|NCT00619229|P1|Participant Flow|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
1077898|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
1077899|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
1077900|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
1077901|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
1077902|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
1077903|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
1077904|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
1077905|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
1077906|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
1077907|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
1077908|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
1077909|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
1077910|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
1077911|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
1077912|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
1077913|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
1077914|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
1077915|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
1077916|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
1077917|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
1077918|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
1077919|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
1077920|NCT00619229|E2|Reported Event|Placebo|Placebo i.v. for 15 days
1077921|NCT00619229|E1|Reported Event|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
1077929|NCT00619190|O2|Outcome|no Medication Control|group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. They may receive behavioral interventions
1077930|NCT00619190|O1|Outcome|Open Aripipraprazole|Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg
1077931|NCT00619190|O2|Outcome|no Medication Control|group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. They may receive behavioral interventions
1077932|NCT00619190|O1|Outcome|Open Aripipraprazole|Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg
1077933|NCT00619190|E2|Reported Event|no Medication Control|group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. They may receive behavioral interventions
1077934|NCT00619190|E1|Reported Event|Open Aripipraprazole|Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg
1077935|NCT00619177|B1|Baseline|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 – 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
1077936|NCT00619177|P1|Participant Flow|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 – 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
1077937|NCT00619177|O1|Outcome|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 – 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
1077938|NCT00619177|O1|Outcome|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 – 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
1077939|NCT00619177|O1|Outcome|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 – 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
1077940|NCT00619177|O1|Outcome|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 – 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
1077941|NCT00619177|O1|Outcome|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 – 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
1077942|NCT00619177|E1|Reported Event|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 - 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
1077943|NCT00619151|B3|Baseline|Total|Total of all reporting groups
1077944|NCT00619151|B2|Baseline|St.Jude Valve|St. Jude Medical Regent Valve
1077945|NCT00619151|B1|Baseline|Top Hat Valve|CarboMedics Supra-annular Top Hat Valve
1077946|NCT00619151|P2|Participant Flow|St.Jude Valve|St. Jude Medical Regent Valve
1077947|NCT00619151|P1|Participant Flow|Top Hat Valve|CarboMedics Supra-annular Top Hat Valve
1077948|NCT00619151|O2|Outcome|St.Jude Valve|St. Jude Medical Regent Valve
1077949|NCT00619151|O1|Outcome|Top Hat Valve|CarboMedics Supra-annular Top Hat Valve
1077950|NCT00619151|O2|Outcome|St.Jude Valve|St. Jude Medical Regent Valve
1077951|NCT00619151|O1|Outcome|Top Hat Valve|CarboMedics Supra-annular Top Hat Valve
1077952|NCT00619151|E2|Reported Event|St.Jude Valve|St. Jude Medical Regent Valve
1077953|NCT00619151|E1|Reported Event|Top Hat Valve|CarboMedics Supra-annular Top Hat Valve
1077954|NCT00619112|B1|Baseline|Temozolomide|"single arm trial~temozolomide : single arm study"
1077955|NCT00619112|P1|Participant Flow|Temozolomide|"single arm trial~temozolomide : single arm study"
1077956|NCT00619112|O1|Outcome|Temozolomide|"single arm trial~temozolomide : single arm study"
1077957|NCT00619112|E1|Reported Event|Temozolomide|"single arm trial~temozolomide : single arm study"
1077958|NCT00619099|B3|Baseline|Total|Total of all reporting groups
1077959|NCT00619099|B2|Baseline|Schedule B: SQ Once Every 7 Days|Decitabine : Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
1077960|NCT00619099|B1|Baseline|Schedule A: SQ 3 Consecutive Days|Decitabine : Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
1077961|NCT00619099|P2|Participant Flow|Schedule B: SQ Once Every 7 Days|Decitabine : Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
1077962|NCT00619099|P1|Participant Flow|Schedule A: SQ 3 Consecutive Days|Decitabine : Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
1077963|NCT00619099|O2|Outcome|Schedule B: SQ Once Every 7 Days|Decitabine : Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
1077964|NCT00619099|O1|Outcome|Schedule A: SQ 3 Consecutive Days|Decitabine : Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
1077965|NCT00619099|E2|Reported Event|Schedule B: SQ Once Every 7 Days|Decitabine : Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
1078109|NCT00618748|P2|Participant Flow|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
1077966|NCT00619099|E1|Reported Event|Schedule A: SQ 3 Consecutive Days|Decitabine : Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
1077967|NCT00619073|B1|Baseline|Entire Study Population|Includes groups randomized to receive clopidogrel + aspirin first and placebo + aspirin first
1078112|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
1077968|NCT00619073|P2|Participant Flow|Placebo Then Clopidogrel|The subjects will be randomized to placebo plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., placebo) will then be discontinued and aspirin continued for another 45 days. After a 30 day washout from completion of first intervention, the subjects will be crossed over to clopidogrel 75 mg plus aspirin 81 mg orally daily for 14 days. The study drug (i.e. clopidogrel) will then be discontinued and aspirin continued for another 45 days.
1077969|NCT00619073|P1|Participant Flow|Clopidogrel Then Placebo|The subjects will be randomized to clopidogrel 75 mg plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., clopidogrel) will then be discontinued and aspirin continued for another 45 days. After a 30 day washout from completion of first intervention, the subjects will be crossed over to placebo plus aspirin 81 mg orally daily for 14 days. The study drug (i.e. placebo) will then be discontinued and aspirin continued for another 45 days.
1077970|NCT00619073|O2|Outcome|Placebo + Aspirin|The subjects will be randomized to placebo plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., placebo) will then be discontinued and aspirin continued for another 43 days.
1077971|NCT00619073|O1|Outcome|Clopidogrel + Aspirin|The subjects will be randomized to clopidogrel 75 mg plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., clopidogrel) will then be discontinued and aspirin continued for another 43 days.
1077972|NCT00619073|E2|Reported Event|Placebo + Aspirin|The subjects will be randomized to placebo plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., placebo) will then be discontinued and aspirin continued for another 43 days.
1077973|NCT00619073|E1|Reported Event|Clopidogrel + Aspirin|The subjects will be randomized to clopidogrel 75 mg plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., clopidogrel) will then be discontinued and aspirin continued for another 43 days.
1077974|NCT00619060|B1|Baseline|Myristyl, Placebo|"Participants apply topical myristyl nicotinate to the and topical placebo to the other forearm once daily for 4 weeks; Myristyl, Placebo~Topical Myristyl Nicotinate Cream and Placebo : Applied topically"
1077975|NCT00619060|P2|Participant Flow|Myristyl (Left), Placebo (Right)|Participants apply topical myristyl nicotinate to the left forearm and topical placebo to the right forearm once daily for 4 weeks; Myristyl (Left), Placebo (Right)Topical Myristyl Nicotinate Cream and Placebo
1077976|NCT00619060|P1|Participant Flow|Myristyl (Right), Placebo (Left)|"Participants apply topical myristyl nicotinate to the right forearm and topical placebo to the left forearm once daily for 4 weeks; Myristyl (Right), Placebo (Left)Topical Myristyl Nicotinate Cream and Placebo~Topical Myristyl Nicotinate Cream and Placebo : Applied topically"
1077977|NCT00619060|O2|Outcome|Topical Placebo Cream|Participants apply topical placebo cream to one forearm.
1077978|NCT00619060|O1|Outcome|Myristyl Nicotinate Cream|Participants apply topical myristyl nicotinate to one forearm.
1077979|NCT00619060|E4|Reported Event|Other Non-Derm Events|Systemic Other Adverse Events, i.e. Common Cold, Migraine
1077980|NCT00619060|E3|Reported Event|Myristyl Forearm (Only)|Forearms receiving the Myristyl
1077981|NCT00619060|E2|Reported Event|Placebo Forearm (Only)|Forearms receiving the Placebo
1077982|NCT00619060|E1|Reported Event|Both Forearms|Forearms receiving the Myristyl and Placebo, both arms affected
1077983|NCT00618995|B1|Baseline|Totals For Study|All participants in the study.
1077984|NCT00618995|P4|Participant Flow|Sequence 4: A/D/B/C|"A = ER Niacin 2 g/Laropiprant 40 mg once daily for 7 days~B = ER Niacin 2 g once daily for 7 days~C = Laropiprant 40 mg once daily for 7 days~D = Placebo once daily for 7 days"
1077985|NCT00618995|P3|Participant Flow|Sequence 3: B/A/C/D|"A = ER Niacin 2 g/Laropiprant 40 mg once daily for 7 days~B = ER Niacin 2 g once daily for 7 days~C = Laropiprant 40 mg once daily for 7 days~D = Placebo once daily for 7 days"
1077986|NCT00618995|P2|Participant Flow|Sequence 2: C/B/D/A|"A = ER Niacin 2 g/Laropiprant 40 mg once daily for 7 days~B = ER Niacin 2 g once daily for 7 days~C = Laropiprant 40 mg once daily for 7 days~D = Placebo once daily for 7 days"
1077987|NCT00618995|P1|Participant Flow|Sequence 1: D/C/A/B|"A = ER Niacin 2 g/Laropiprant 40 mg once daily for 7 days~B = ER Niacin 2 g once daily for 7 days~C = Laropiprant 40 mg once daily for 7 days~D = Placebo once daily for 7 days"
1077988|NCT00618995|O4|Outcome|Placebo|Placebo once daily for 7 days
1077989|NCT00618995|O3|Outcome|Laropiprant|Laropiprant 40 mg once daily for 7 days
1077990|NCT00618995|O2|Outcome|ER Niacin|ER Niacin 2 g once daily for 7 days
1077991|NCT00618995|O1|Outcome|ER Niacin/Laropiprant|Extended Release (ER) Niacin 2 g/Laropiprant 40 mg once daily for 7 days
1077992|NCT00618995|O4|Outcome|Placebo|Placebo once daily for 7 days
1077993|NCT00618995|O3|Outcome|Laropiprant|Laropiprant 40 mg once daily for 7 days
1077994|NCT00618995|O2|Outcome|ER Niacin|ER Niacin 2 g once daily for 7 days
1077995|NCT00618995|O1|Outcome|ER Niacin/Laropiprant|Extended Release (ER) Niacin 2 g/Laropiprant 40 mg once daily for 7 days
1077996|NCT00618995|E4|Reported Event|Placebo|Placebo once daily for 7 days
1077997|NCT00618995|E3|Reported Event|Laropiprant|Laropiprant 40 mg once daily for 7 days
1077998|NCT00618995|E2|Reported Event|ER Niacin|ER Niacin 2 g once daily for 7 days
1077999|NCT00618995|E1|Reported Event|ER Niacin/Laropiprant|Extended Release (ER) Niacin 2 g/Laropiprant 40 mg once daily for 7 days
1078000|NCT00618982|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
1078001|NCT00618982|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
1078110|NCT00618748|P1|Participant Flow|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
1079586|NCT00615108|O2|Outcome|Micardis 80mg|Telmisartan 80 mg
1078002|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
1080196|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
1078003|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
1078004|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
1078005|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
1078006|NCT00618982|O3|Outcome|Sorafenib (Nexavar, BAY43-9006)_800 mg|Participants received 800 mg orally twice daily (bid)
1078007|NCT00618982|O2|Outcome|Sorafenib (Nexavar, BAY43-9006)_600 mg|Participants received 600 mg orally twice daily (bid)
1078008|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)_400 mg|Participants received 400 mg orally twice daily (bid)
1078009|NCT00618982|O3|Outcome|Sorafenib (Nexavar, BAY43-9006)_800 mg|Participants received 800 mg orally twice daily (bid)
1078010|NCT00618982|O2|Outcome|Sorafenib (Nexavar, BAY43-9006)_600 mg|Participants received 600 mg orally twice daily (bid)
1078011|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)_400 mg|Participants received 400 mg orally twice daily (bid)
1078012|NCT00618982|O3|Outcome|Sorafenib (Nexavar, BAY43-9006)_800 mg|Participants received 800 mg orally twice daily (bid)
1078013|NCT00618982|O2|Outcome|Sorafenib (Nexavar, BAY43-9006)_600 mg|Participants received 600 mg orally twice daily (bid)
1078014|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)_400 mg|Participants received 400 mg orally twice daily (bid)
1078015|NCT00618982|O3|Outcome|Sorafenib (Nexavar, BAY43-9006)_800 mg|Participants received 800 mg orally twice daily (bid)
1078016|NCT00618982|O2|Outcome|Sorafenib (Nexavar, BAY43-9006)_600 mg|Participants received 600 mg orally twice daily (bid)
1078017|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)_400 mg|Participants received 400 mg orally twice daily (bid)
1078018|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
1078019|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
1078020|NCT00618982|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle,600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
1078021|NCT00618956|B3|Baseline|Total|Total of all reporting groups
1078022|NCT00618956|B2|Baseline|Milnacipran|
1078023|NCT00618956|B1|Baseline|Placebo|
1078024|NCT00618956|P2|Participant Flow|Milnacipran|Milnacipran 100 to 200 mg/day tablet, oral administration, BID.
1078025|NCT00618956|P1|Participant Flow|Placebo|ITT N= 93, OC analyzed n=89
1078026|NCT00618956|O2|Outcome|Milnacipran|ITT N=181, OC analyzed n=162
1078027|NCT00618956|O1|Outcome|Placebo|ITT N=93, OC analyzed n=84
1078028|NCT00618956|O2|Outcome|Milnacipran|ITT N= 181, OC analyzed n=176
1078029|NCT00618956|O1|Outcome|Placebo|ITT N= 93, OC analyzed n=89
1078030|NCT00618956|O2|Outcome|Milnacipran|ITT N=181, OC analyzed n=162
1078031|NCT00618956|O1|Outcome|Placebo|ITT N=93, OC analyzed n=84
1078032|NCT00618956|O2|Outcome|Milnacipran|Normotensive: ITT N= 93, OC analyzed n=82; hypertensive: ITT N=88, OC analyzed n=80
1078033|NCT00618956|O1|Outcome|Placebo|Normotensive: ITT N= 42, OC analyzed n=37; hypertensive: ITT N=51, OC analyzed n=47
1078034|NCT00618956|O2|Outcome|Milnacipran|ITT N= 181, OC analyzed n=176
1078035|NCT00618956|O1|Outcome|Placebo|ITT N= 93, OC analyzed n=89
1078036|NCT00618956|O2|Outcome|Milnacipran|Normotensive: ITT N=93, OC analyzed n=92; hypertensive: ITT N=88, OC analyzed n=84
1078037|NCT00618956|O1|Outcome|Placebo|Normotensive: ITT N=42, OC analyzed n=39; hypertensive: ITT N=51, OC analyzed n=50
1078038|NCT00618956|E2|Reported Event|Milnacipran|Milnacipran 100 to 200 mg/day tablet, oral administration, BID.
1078039|NCT00618956|E1|Reported Event|Placebo|ITT N= 93, OC analyzed n=89
1078040|NCT00618839|B1|Baseline|StrataGraft : Cadaver Allograft|Wounds were excised and the half-wound sites were randomized to receive StrataGraft skin tissue or cadaver allograft for 7 days until the wounds were ready for autografting.
1078041|NCT00618839|P1|Participant Flow|StrataGraft : Cadaver Allograft|Wounds were excised and the half-wound sites were randomized to receive StrataGraft skin tissue or cadaver allograft for 7 days until the wounds were ready for autografting.
1078042|NCT00618839|O2|Outcome|Cadaver Skin|The current standard of care for the management of severe burns or other major skin trauma is temporary coverage of the wound with cadaver skin followed by subsequent autografting once the wound bed has become healthy enough to accept an autograft. Excised wounds are covered temporarily with cadaver skin to reduce fluid loss and infection. In addition to preventing excessive dehydration, restoration of a permeability barrier maintains a moist wound environment which promotes wound healing. However, there is inconsistent availability of freshly-harvested cadaver grafts. In addition, the quality of cadaver skin is variable- cadaver skin is often contaminated and if cadaver skin had undergone prolonged storage or freezing this reduces the viability of cadaver skin.
1078111|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
1079138|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
1078113|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
1078114|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
1078043|NCT00618839|O1|Outcome|StrataGraft|StrataGraft skin tissue is a fully-differentiated tissue which exhibits barrier function comparable to that of intact human skin. StrataGraft consists of an epidermal layer of fully-stratified human keratinocytes growing on a dermal layer which is comprised of human fibroblasts embedded in a collagen matrix. StrataGraft skin tissue is a tough, suturable, meshable tissue product that is manufactured with a surface area of 44 cm2. StrataGraft tissue is not intended to be a patient-specific product but rather to provide an allogeneic skin substitute which reproduces many of the structural and biological properties of normal human skin and is anticipated to serve as a biological wound dressing.
1078044|NCT00618839|O2|Outcome|Cadaver Skin|The current standard of care for the management of severe burns or other major skin trauma is temporary coverage of the wound with cadaver skin followed by subsequent autografting once the wound bed has become healthy enough to accept an autograft. Excised wounds are covered temporarily with cadaver skin to reduce fluid loss and infection. In addition to preventing excessive dehydration, restoration of a permeability barrier maintains a moist wound environment which promotes wound healing. However, there is inconsistent availability of freshly-harvested cadaver grafts. In addition, the quality of cadaver skin is variable- cadaver skin is often contaminated and if cadaver skin had undergone prolonged storage or freezing this reduces the viability of cadaver skin.
1078045|NCT00618839|O1|Outcome|StrataGraft|StrataGraft skin tissue is a fully-differentiated tissue which exhibits barrier function comparable to that of intact human skin. StrataGraft consists of an epidermal layer of fully-stratified human keratinocytes growing on a dermal layer which is comprised of human fibroblasts embedded in a collagen matrix. StrataGraft skin tissue is a tough, suturable, meshable tissue product that is manufactured with a surface area of 44 cm2. StrataGraft tissue is not intended to be a patient-specific product but rather to provide an allogeneic skin substitute which reproduces many of the structural and biological properties of normal human skin and is anticipated to serve as a biological wound dressing.
1078046|NCT00618839|O2|Outcome|Cadaver Skin|The current standard of care for the management of severe burns or other major skin trauma is temporary coverage of the wound with cadaver skin followed by autografting once once sufficient donor skin is available for autografting. Excised wounds are covered temporarily with cadaver skin to reduce fluid loss and infection. In addition to preventing excessive dehydration, restoration of a permeability barrier maintains a moist wound environment which promotes wound healing. However, there is inconsistent availability of freshly-harvested cadaver grafts. In addition, the quality of cadaver skin is variable- cadaver skin is often contaminated and if cadaver skin had undergone prolonged storage or freezing this reduces the viability of cadaver skin.
1078047|NCT00618839|O1|Outcome|StrataGraft Skin Tissue|StrataGraft skin tissue is a fully-differentiated tissue which exhibits barrier function comparable to that of intact human skin. StrataGraft consists of an epidermal layer of fully-stratified human keratinocytes growing on a dermal layer which is comprised of human fibroblasts embedded in a collagen matrix. StrataGraft skin tissue is a tough, suturable, meshable tissue product that is manufactured with a surface area of 44 cm2. StrataGraft tissue is not intended to be a patient-specific product but rather to provide an allogeneic skin substitute which reproduces many of the structural and biological properties of normal human skin and is anticipated to serve as a biological wound dressing.
1078048|NCT00618839|E1|Reported Event|StrataGraft : Cadaver Allograft|Wounds were excised and the half-wound sites were randomized to receive StrataGraft skin tissue or cadaver allograft for 7 days until the wounds were ready for autografting.
1078049|NCT00618826|B1|Baseline|Treatment Period|"Treatment will be administered once every 2 weeks. One cycle of therapy will consist of 14 days. Paclitaxel is administered first after appropriate premedications. Gemcitabine is administered second and Avastin is administered after chemotherapy, all given on day 1 of each cycle.~Paclitaxel: Patients will be premedicated with dexamethasone and diphenhydramine hydrochloride. Patients will received 150mg of paclitaxel via IV over 120 mins.~Gemcitabine: Patients will receive 1500mg of Gemcitabine via IV over 30-60 minutes. Gemcitabine will be given after Paclitaxel.~Avastin: 10mg/kg will be given via IV over 90 mins (1st dose). Patients must remain under supervision for 1 hr after completion of the initial dose of Avastin. If no side effects occur, shortened, 60-min 2nd infusion, the post-infusion observation period for the subsequent infusions may be shortened to 20 minutes, and eliminated entirely with the fourth and subsequent infusions."
1078050|NCT00618826|P1|Participant Flow|Paclitaxel + Gemcitabine + Avastin|"Treatment administered once every 2 weeks, 1 cycle will consist of 14 days.~Paclitaxel (administered first) - Patients will be pre-medicated with dexamethasone and diphenhydramine hydrochloride. Patients will received 150mg of paclitaxel via IV over 120 mins.~Gemcitabine (given after Paclitaxel) - Patients will receive 1500mg of Gemcitabine via IV over 30-60 minutes. Gemcitabine will be given after Paclitaxel.~Avastin - 10mg/kg will be given via IV over 90 mins (1st dose). Patients must remain under supervision for 1 hr after completion of the initial dose of Avastin. If no side effects occur, shortened, 60-min 2nd infusion, the post-infusion observation period for the subsequent infusions may be shortened to 20 minutes, and eliminated entirely with the fourth and subsequent infusions."
1078051|NCT00618826|O1|Outcome|Arm 1|all participants
1078052|NCT00618826|O1|Outcome|Treatment|Paclitaxel / Gemcitabine
1078053|NCT00618826|E1|Reported Event|Treatment Period|Treatment will be administered once every 2 weeks. One cycle of therapy will consist of 14 days. Paclitaxel is administered first after appropriate premedications. Gemcitabine is administered second and Avastin is administered after chemotherapy, all given on day 1 of each cycle.
1078054|NCT00618813|B1|Baseline|Treatment (Combination Chemotherapy)|"See Detailed Description~radiation therapy: Undergo radiation therapy~therapeutic conventional surgery: Undergo surgery~etoposide: Given IV~ifosfamide: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~topotecan hydrochloride: Given IV~filgrastim: Given SC"
1078055|NCT00618813|P1|Participant Flow|Treatment (Combination Chemotherapy)|"See Detailed Description~radiation therapy: Undergo radiation therapy~therapeutic conventional surgery: Undergo surgery~etoposide: Given IV~ifosfamide: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~topotecan hydrochloride: Given IV~filgrastim: Given SC"
1078056|NCT00618813|O1|Outcome|Treatment (Combination Chemotherapy)|"See Detailed Description~radiation therapy: Undergo radiation therapy~therapeutic conventional surgery: Undergo surgery~etoposide: Given IV~ifosfamide: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~topotecan hydrochloride: Given IV~filgrastim: Given SC"
1078308|NCT00618410|O2|Outcome|Placebo|nasal placebo administered 30 minutes prior to nasal challenge
1078057|NCT00618813|O1|Outcome|Treatment (Combination Chemotherapy)|"See Detailed Description~radiation therapy: Undergo radiation therapy~therapeutic conventional surgery: Undergo surgery~etoposide: Given IV~ifosfamide: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~topotecan hydrochloride: Given IV~filgrastim: Given SC"
1078058|NCT00618813|O1|Outcome|Treatment (Combination Chemotherapy)|"See Detailed Description~radiation therapy: Undergo radiation therapy~therapeutic conventional surgery: Undergo surgery~etoposide: Given IV~ifosfamide: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~topotecan hydrochloride: Given IV~filgrastim: Given SC"
1078059|NCT00618813|O1|Outcome|Treatment (Combination Chemotherapy)|"See Detailed Description~radiation therapy: Undergo radiation therapy~therapeutic conventional surgery: Undergo surgery~etoposide: Given IV~ifosfamide: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~topotecan hydrochloride: Given IV~filgrastim: Given SC"
1078060|NCT00618813|O1|Outcome|Treatment (Combination Chemotherapy)|"See Detailed Description~radiation therapy: Undergo radiation therapy~therapeutic conventional surgery: Undergo surgery~etoposide: Given IV~ifosfamide: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~topotecan hydrochloride: Given IV~filgrastim: Given SC"
1078061|NCT00618813|E1|Reported Event|Treatment (Combination Chemotherapy)|"See Detailed Description~radiation therapy: Undergo radiation therapy~therapeutic conventional surgery: Undergo surgery~etoposide: Given IV~ifosfamide: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~topotecan hydrochloride: Given IV~filgrastim: Given SC"
1078062|NCT00618787|B3|Baseline|Total|Total of all reporting groups
1078063|NCT00618787|B2|Baseline|COPA|Regular foam dressing without Polyhexamethylene Biguanide
1078064|NCT00618787|B1|Baseline|COPA AMD|Foam dressing impregnated with Polyhexamethylene Biguanide
1078065|NCT00618787|P2|Participant Flow|COPA|Regular foam dressing without Polyhexamethylene Biguanide
1078066|NCT00618787|P1|Participant Flow|COPA AMD|Foam dressing impregnated with Polyhexamethylene Biguanide
1078067|NCT00618787|O2|Outcome|COPA|Regular foam dressing without Polyhexamethylene Biguanide
1078068|NCT00618787|O1|Outcome|COPA AMD|Foam dressing impregnated with Polyhexamethylene Biguanide
1078069|NCT00618787|E2|Reported Event|COPA|Regular foam dressing without Polyhexamethylene Biguanide
1078070|NCT00618787|E1|Reported Event|COPA AMD|Foam dressing impregnated with Polyhexamethylene Biguanide
1078071|NCT00618774|B3|Baseline|Total|Total of all reporting groups
1078072|NCT00618774|B2|Baseline|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
1078073|NCT00618774|B1|Baseline|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
1078074|NCT00618774|P2|Participant Flow|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
1078075|NCT00618774|P1|Participant Flow|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
1078076|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
1078077|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
1078078|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
1078079|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
1078080|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
1078081|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
1078082|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
1078083|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
1078084|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
1078085|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
1078086|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
1078087|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
1078088|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
1078089|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
1078090|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
1078091|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
1078092|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
1078093|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
1078094|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
1078095|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
1078096|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
1078097|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
1078098|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
1078099|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
1078100|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
1078101|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
1078102|NCT00618774|E2|Reported Event|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
1078103|NCT00618774|E1|Reported Event|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
1078104|NCT00618748|B4|Baseline|Total|Total of all reporting groups
1078105|NCT00618748|B3|Baseline|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
1078106|NCT00618748|B2|Baseline|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
1078107|NCT00618748|B1|Baseline|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
1078108|NCT00618748|P3|Participant Flow|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
1078115|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
1078116|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
1078117|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
1078118|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
1078119|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
1078120|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
1078121|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
1078122|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
1078123|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
1078124|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
1078125|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
1078126|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
1078127|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
1078128|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
1078129|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
1078130|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
1078131|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
1078132|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
1078133|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
1078134|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
1078135|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
1078136|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
1078137|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
1078138|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
1078139|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
1078140|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
1078141|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
1078142|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
1078143|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
1078144|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
1078145|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
1078146|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
1078147|NCT00618748|E3|Reported Event|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
1078148|NCT00618748|E2|Reported Event|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
1078149|NCT00618748|E1|Reported Event|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
1078150|NCT00618722|B5|Baseline|Total|Total of all reporting groups
1078151|NCT00618722|B4|Baseline|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078309|NCT00618410|O1|Outcome|Carbon Dioxide|nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
1079139|NCT00616655|O1|Outcome|Placebo Arm|Placebo
1078152|NCT00618722|B3|Baseline|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078153|NCT00618722|B2|Baseline|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078154|NCT00618722|B1|Baseline|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078155|NCT00618722|P4|Participant Flow|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078156|NCT00618722|P3|Participant Flow|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078157|NCT00618722|P2|Participant Flow|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078158|NCT00618722|P1|Participant Flow|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078159|NCT00618722|O4|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078160|NCT00618722|O3|Outcome|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078161|NCT00618722|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078162|NCT00618722|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078163|NCT00618722|O4|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078164|NCT00618722|O3|Outcome|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078165|NCT00618722|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078166|NCT00618722|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078167|NCT00618722|O4|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078168|NCT00618722|O3|Outcome|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078169|NCT00618722|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078170|NCT00618722|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078171|NCT00618722|O4|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078172|NCT00618722|O3|Outcome|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078173|NCT00618722|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078174|NCT00618722|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078175|NCT00618722|O4|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078176|NCT00618722|O3|Outcome|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078177|NCT00618722|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078178|NCT00618722|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078179|NCT00618722|O4|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1079587|NCT00615108|O1|Outcome|Micardis 40mg|Telmisartan 40 mg
1078180|NCT00618722|O3|Outcome|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078181|NCT00618722|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078182|NCT00618722|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078183|NCT00618722|O4|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078184|NCT00618722|O3|Outcome|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078185|NCT00618722|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078186|NCT00618722|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078187|NCT00618722|E4|Reported Event|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078188|NCT00618722|E3|Reported Event|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078189|NCT00618722|E2|Reported Event|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078190|NCT00618722|E1|Reported Event|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078191|NCT00618618|B5|Baseline|Total|Total of all reporting groups
1078192|NCT00618618|B4|Baseline|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078193|NCT00618618|B3|Baseline|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078194|NCT00618618|B2|Baseline|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078195|NCT00618618|B1|Baseline|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078196|NCT00618618|P4|Participant Flow|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078197|NCT00618618|P3|Participant Flow|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078198|NCT00618618|P2|Participant Flow|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078199|NCT00618618|P1|Participant Flow|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078200|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078201|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078202|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078203|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078204|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078205|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078206|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078310|NCT00618410|O2|Outcome|Placebo|nasal placebo administered 30 minutes prior to nasal challenge
1079588|NCT00615108|O3|Outcome|Total|Telmisartan 40mg or 80 mg
1078207|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078208|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078209|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078210|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078211|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078212|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078213|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078214|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078215|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078216|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078217|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078218|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078219|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078220|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078221|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078222|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078223|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078224|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078225|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078226|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078227|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078228|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078229|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078230|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078231|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078232|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078233|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078234|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078235|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078236|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078237|NCT00618618|O3|Outcome|0Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078238|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078239|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078240|NCT00618618|E4|Reported Event|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078241|NCT00618618|E3|Reported Event|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078242|NCT00618618|E2|Reported Event|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078243|NCT00618618|E1|Reported Event|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
1078244|NCT00618540|B1|Baseline|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
1078245|NCT00618540|P1|Participant Flow|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
1078246|NCT00618540|O1|Outcome|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
1078247|NCT00618540|O1|Outcome|Alemtuzumab|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
1078248|NCT00618540|O1|Outcome|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
1078249|NCT00618540|O1|Outcome|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
1078250|NCT00618540|O1|Outcome|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
1078311|NCT00618410|O1|Outcome|Carbon Dioxide|nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
1078274|NCT00618514|O1|Outcome|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
1078275|NCT00618514|E2|Reported Event|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
1078251|NCT00618540|O1|Outcome|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
1078252|NCT00618540|O1|Outcome|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
1078253|NCT00618540|O1|Outcome|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
1078254|NCT00618540|E1|Reported Event|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
1078255|NCT00618514|B3|Baseline|Total|Total of all reporting groups
1078256|NCT00618514|B2|Baseline|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
1078257|NCT00618514|B1|Baseline|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
1078258|NCT00618514|P3|Participant Flow|Bright Tip Laser & Bare Tip Laser|Subjects that received testament of both limbs using the investigational device (Bright Tip laser) and the control (bare tip laser)
1078259|NCT00618514|P2|Participant Flow|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts. Subjects in this arm had only one limb treated with the bare tip laser fiber (control).
1078260|NCT00618514|P1|Participant Flow|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts. Subjects in this category had only one limb treated with the Bright tip laser fiber.
1078261|NCT00618514|O2|Outcome|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
1078262|NCT00618514|O1|Outcome|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
1078263|NCT00618514|O2|Outcome|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
1078264|NCT00618514|O1|Outcome|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
1078265|NCT00618514|O2|Outcome|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
1078266|NCT00618514|O1|Outcome|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
1078267|NCT00618514|O2|Outcome|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
1078268|NCT00618514|O1|Outcome|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
1078269|NCT00618514|O2|Outcome|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
1078270|NCT00618514|O1|Outcome|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
1078271|NCT00618514|O2|Outcome|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
1078272|NCT00618514|O1|Outcome|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
1078273|NCT00618514|O2|Outcome|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
1078312|NCT00618410|O2|Outcome|Placebo|nasal placebo administered 30 minutes prior to nasal challenge
1078276|NCT00618514|E1|Reported Event|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
1078277|NCT00618449|B3|Baseline|Total|Total of all reporting groups
1078278|NCT00618449|B2|Baseline|Single-dose Azithromcyin|Subjects residing in villages assigned to treatment arm 1 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0); received the WHO standard of care for trachoma - 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
1078279|NCT00618449|B1|Baseline|Two-doses of Azithromycin|Subjects residing in villages assigned to treatment arm 2 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0) followed by an initial treatment with 1 gm oral dose of Azithromycin; received a second 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
1078280|NCT00618449|P2|Participant Flow|Single-dose Azithromcyin|Subjects residing in villages assigned to treatment arm 1 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0); received the WHO standard of care for trachoma - 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
1078281|NCT00618449|P1|Participant Flow|Two-doses of Azithromycin|Subjects residing in villages assigned to treatment arm 2 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0) followed by an initial treatment with 1 gm oral dose of Azithromycin; received a second 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
1078282|NCT00618449|O2|Outcome|Single-dose Azithromcyin|Subjects residing in villages assigned to treatment arm 1 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0); received the WHO standard of care for trachoma - 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
1078283|NCT00618449|O1|Outcome|Two-doses of Azithromycin|Subjects residing in villages assigned to treatment arm 2 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0) followed by an initial treatment with 1 gm oral dose of Azithromycin; received a second 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
1078284|NCT00618449|E2|Reported Event|Single-dose Azithromcyin|Subjects residing in villages assigned to treatment arm 1 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0); received the WHO standard of care for trachoma - 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
1078285|NCT00618449|E1|Reported Event|Two-doses of Azithromycin|Subjects residing in villages assigned to treatment arm 2 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0) followed by an initial treatment with 1 gm oral dose of Azithromycin; received a second 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
1078286|NCT00618436|B3|Baseline|Total|Total of all reporting groups
1078287|NCT00618436|B2|Baseline|Phenytoin|This group will receive treatment with Phenytoin.
1078288|NCT00618436|B1|Baseline|Levetiracetam|This group will receive treatment with Levetiracetam.
1078289|NCT00618436|P2|Participant Flow|Phenytoin|This group will receive treatment with Phenytoin.
1078290|NCT00618436|P1|Participant Flow|Levetiracetam|This group will receive treatment with Levetiracetam.
1078291|NCT00618436|O2|Outcome|Phenytoin|This group will receive treatment with Phenytoin.
1078292|NCT00618436|O1|Outcome|Levetiracetam|This group will receive treatment with Levetiracetam.
1078293|NCT00618436|O2|Outcome|Phenytoin|This group will receive treatment with Phenytoin.
1078294|NCT00618436|O1|Outcome|Levetiracetam|This group will receive treatment with Levetiracetam.
1078295|NCT00618436|O2|Outcome|Phenytoin|This group will receive treatment with Phenytoin.
1078296|NCT00618436|O1|Outcome|Levetiracetam|This group will receive treatment with Levetiracetam.
1078297|NCT00618436|E2|Reported Event|Phenytoin|This group will receive treatment with Phenytoin.
1078298|NCT00618436|E1|Reported Event|Levetiracetam|This group will receive treatment with Levetiracetam.
1078299|NCT00618410|B1|Baseline|Entire Study Population|Study population includes subjects receiving interventions in either order.
1078300|NCT00618410|P2|Participant Flow|Placebo, Then Carbon Dioxide|"Intervention sequence:~Intervention #1: nasal placebo administered 30 minutes prior to nasal challenge~Intervention #2: nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge"
1078301|NCT00618410|P1|Participant Flow|Carbon Dioxide, Then Placebo|"Intervention sequence:~Intervention #1: nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge~Intervention #2: nasal placebo administered 30 minutes prior to nasal challenge"
1078302|NCT00618410|O2|Outcome|Placebo|nasal placebo administered 30 minutes prior to nasal challenge
1078303|NCT00618410|O1|Outcome|Carbon Dioxide|nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
1078304|NCT00618410|O2|Outcome|Placebo|nasal placebo administered 30 minutes prior to nasal challenge
1078305|NCT00618410|O1|Outcome|Carbon Dioxide|nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
1078306|NCT00618410|O2|Outcome|Placebo|nasal placebo administered 30 minutes prior to nasal challenge
1078307|NCT00618410|O1|Outcome|Carbon Dioxide|nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
1079589|NCT00615108|O2|Outcome|Micardis 80mg|Telmisartan 80 mg
1078313|NCT00618410|O1|Outcome|Carbon Dioxide|nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
1078314|NCT00618410|E2|Reported Event|Placebo|nasal placebo administered 30 minutes prior to nasal challenge
1078315|NCT00618410|E1|Reported Event|Carbon Dioxide|nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
1078316|NCT00618371|B1|Baseline|Group 1|Group receiving raltegravir
1078318|NCT00618371|O1|Outcome|Raltegravir Intensification|participants received 4 wk raltegravir intensification. Samples from 0 participants were analyzed No Patients experienced ≥ 1 log decline in viral RNA, so no samples could be analyzed
1078319|NCT00618371|O1|Outcome|Raltegravir Intensification|participants received 4 wk raltegravir intensification
1078320|NCT00618371|E1|Reported Event|Group 1|group treated with raltegravir
1078321|NCT00618332|B3|Baseline|Total|Total of all reporting groups
1078322|NCT00618332|B2|Baseline|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
1078323|NCT00618332|B1|Baseline|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
1078324|NCT00618332|P2|Participant Flow|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
1078325|NCT00618332|P1|Participant Flow|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
1078326|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
1078327|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
1078328|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
1078329|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
1078330|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
1078331|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
1078332|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
1078333|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
1078334|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
1078335|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
1078336|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
1078337|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
1078338|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
1078339|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
1078340|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
1078341|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
1078342|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
1078343|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
1078344|NCT00618332|E2|Reported Event|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
1078345|NCT00618332|E1|Reported Event|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
1078346|NCT00618072|B4|Baseline|Total|Total of all reporting groups
1078347|NCT00618072|B3|Baseline|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day
1078348|NCT00618072|B2|Baseline|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day
1078349|NCT00618072|B1|Baseline|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day
1078350|NCT00618072|P3|Participant Flow|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
1078351|NCT00618072|P2|Participant Flow|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
1078352|NCT00618072|P1|Participant Flow|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
1078353|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
1078354|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
1078436|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
1078437|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
1078355|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
1078356|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
1078357|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
1078358|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
1078359|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
1078360|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
1078361|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
1078362|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
1078363|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
1078364|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
1078365|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
1078366|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
1078367|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
1078368|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
1078369|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
1078370|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
1078371|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
1078372|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
1078373|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
1078434|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
1079590|NCT00615108|O1|Outcome|Micardis 40mg|Telmisartan 40 mg
1078374|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
1078375|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
1078376|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
1078377|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
1078378|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
1078379|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
1078380|NCT00618072|E3|Reported Event|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a a total dose of 4 mg/day
1078381|NCT00618072|E2|Reported Event|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone placebo 2mg/day added at weeks 3 and weeks 4 to a a total dose of 4 mg/day
1078382|NCT00618072|E1|Reported Event|A: EMPOWIR and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a a total dose of 4 mg/day
1078383|NCT00617981|B3|Baseline|Total|Total of all reporting groups
1078384|NCT00617981|B2|Baseline|Sham + RFA|"Sham infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.~5% Dextrose Solution: Single 30 minute intravenous infusion"
1078385|NCT00617981|B1|Baseline|ThermoDox + RFA|"ThermoDox 50 mg/m2 start infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.~ThermoDox: Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion"
1078386|NCT00617981|P2|Participant Flow|Sham + RFA|"Sham infusion should start approximately 15 minutes before radiofrequency ablation begins and continue for approximately 30 minutes.~5% Dextrose Solution: Single 30 minute intravenous infusion"
1078387|NCT00617981|P1|Participant Flow|ThermoDox + RFA|"ThermoDox should be administered at 50 mg/m2. The infusion should start approximately 15 minutes before radiofrequency ablation begins and continue for approximately 30 minutes.~ThermoDox: Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion"
1078388|NCT00617981|O2|Outcome|Sham + RFA|"Sham infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.~5% Dextrose Solution: Single 30 minute intravenous infusion"
1078389|NCT00617981|O1|Outcome|ThermoDox + RFA|"ThermoDox 50 mg/m2 start infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.~ThermoDox: Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion"
1078390|NCT00617981|E2|Reported Event|Sham + RFA|"Sham infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.~5% Dextrose Solution: Single 30 minute intravenous infusion"
1078391|NCT00617981|E1|Reported Event|ThermoDox + RFA|"ThermoDox 50 mg/m2 start infusion over 30 minutes about 15 minutes before radiofrequency ablation begins.~ThermoDox: Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion"
1078392|NCT00617929|B1|Baseline|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
1078393|NCT00617929|P1|Participant Flow|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
1078394|NCT00617929|O1|Outcome|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
1078395|NCT00617929|O1|Outcome|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
1078435|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
1079591|NCT00615108|E1|Reported Event|Hypertension Patients|Telmisartan 40mg or 80 mg
1078438|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
1078439|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
1078396|NCT00617929|O1|Outcome|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
1078397|NCT00617929|O1|Outcome|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
1078398|NCT00617929|O1|Outcome|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
1078399|NCT00617929|O1|Outcome|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
1078400|NCT00617929|O1|Outcome|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
1078401|NCT00617929|E1|Reported Event|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
1078402|NCT00617903|B3|Baseline|Total|Total of all reporting groups
1078403|NCT00617903|B2|Baseline|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
1078404|NCT00617903|B1|Baseline|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
1078405|NCT00617903|P2|Participant Flow|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
1078406|NCT00617903|P1|Participant Flow|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
1078407|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
1078408|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
1078409|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
1078410|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
1078411|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
1078412|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
1078413|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
1078414|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
1078415|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
1078416|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
1078417|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
1078418|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
1078419|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
1078420|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
1078421|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
1078422|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
1078423|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
1078424|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
1078425|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
1078426|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
1078427|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
1078428|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
1078429|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
1078430|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
1078431|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
1078432|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
1078433|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
1079665|NCT00615017|B1|Baseline|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
1078440|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
1078441|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
1078442|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
1078443|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
1078444|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
1078445|NCT00617903|E2|Reported Event|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
1078446|NCT00617903|E1|Reported Event|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
1078447|NCT00617890|B5|Baseline|Total|Total of all reporting groups
1078448|NCT00617890|B4|Baseline|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
1078449|NCT00617890|B3|Baseline|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
1078450|NCT00617890|B2|Baseline|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
1078451|NCT00617890|B1|Baseline|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
1078452|NCT00617890|P4|Participant Flow|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
1078453|NCT00617890|P3|Participant Flow|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
1078454|NCT00617890|P2|Participant Flow|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
1078455|NCT00617890|P1|Participant Flow|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
1078456|NCT00617890|O2|Outcome|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
1078457|NCT00617890|O1|Outcome|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
1078458|NCT00617890|O2|Outcome|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
1078459|NCT00617890|O1|Outcome|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
1078460|NCT00617890|O2|Outcome|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
1078461|NCT00617890|O1|Outcome|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
1079666|NCT00615017|P6|Participant Flow|Placebo|Placebo
1078462|NCT00617890|O4|Outcome|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
1078510|NCT00617851|O5|Outcome|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influenza virus vaccine
1078463|NCT00617890|O3|Outcome|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
1078464|NCT00617890|O2|Outcome|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
1078465|NCT00617890|O1|Outcome|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
1078466|NCT00617890|O4|Outcome|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
1078467|NCT00617890|O3|Outcome|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
1078468|NCT00617890|O2|Outcome|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
1078469|NCT00617890|O1|Outcome|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
1078470|NCT00617890|O2|Outcome|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
1078471|NCT00617890|O1|Outcome|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
1078472|NCT00617890|O2|Outcome|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
1078473|NCT00617890|O1|Outcome|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
1078474|NCT00617890|O4|Outcome|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
1078475|NCT00617890|O3|Outcome|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
1078476|NCT00617890|O2|Outcome|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
1078508|NCT00617851|O2|Outcome|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influenza virus vaccine
1078509|NCT00617851|O1|Outcome|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influenza virus vaccine
1082021|NCT00609973|O1|Outcome|Cipro|Ciprofloxacin 500 mg bid
1078511|NCT00617851|O4|Outcome|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influenza virus vaccine
1078512|NCT00617851|O3|Outcome|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influenza virus vaccine
1078477|NCT00617890|O1|Outcome|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
1078478|NCT00617890|O1|Outcome|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
1078479|NCT00617890|O2|Outcome|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
1078480|NCT00617890|O1|Outcome|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
1078481|NCT00617890|O1|Outcome|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
1078482|NCT00617890|E4|Reported Event|Group 3: 10mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
1078483|NCT00617890|E3|Reported Event|Group 2: 10mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
1078484|NCT00617890|E2|Reported Event|Group 1: 10mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
1078485|NCT00617890|E1|Reported Event|Group 1: 0.3mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
1078486|NCT00617851|B5|Baseline|Total|Total of all reporting groups
1078487|NCT00617851|B4|Baseline|Comparator Influenza Vaccine|One injection of the comparator influenza virus vaccine
1078488|NCT00617851|B3|Baseline|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influenza virus vaccine
1078489|NCT00617851|B2|Baseline|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influenza virus vaccine
1078490|NCT00617851|B1|Baseline|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influenza virus vaccine
1078491|NCT00617851|P4|Participant Flow|Comparator Influenza Vaccine|One injection of the comparator influeza virus vaccine
1078492|NCT00617851|P3|Participant Flow|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influeza virus vaccine
1078493|NCT00617851|P2|Participant Flow|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influeza virus vaccine
1078494|NCT00617851|P1|Participant Flow|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influeza virus vaccine
1078495|NCT00617851|O5|Outcome|Comparator Influenza Vaccine|One injection of the comparator influenza virus vaccine
1078496|NCT00617851|O4|Outcome|Influenza Virus Vaccine (Pooled)|One injection of the investigational influenza virus vaccine (all lots pooled)
1078497|NCT00617851|O3|Outcome|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influenza virus vaccine
1078498|NCT00617851|O2|Outcome|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influenza virus vaccine
1078499|NCT00617851|O1|Outcome|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influenza virus vaccine
1078500|NCT00617851|O5|Outcome|Comparator Influenza Vaccine|One injection of the comparator influenza virus vaccine
1078501|NCT00617851|O4|Outcome|Influenza Virus Vaccine (Pooled)|One injection of the investigational influenza virus vaccine (all lots pooled)
1078502|NCT00617851|O3|Outcome|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influenza virus vaccine
1078503|NCT00617851|O2|Outcome|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influenza virus vaccine
1078504|NCT00617851|O1|Outcome|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influenza virus vaccine
1078505|NCT00617851|O5|Outcome|Comparator Influenza Vaccine|One injection of the comparator influenza virus vaccine
1078506|NCT00617851|O4|Outcome|Influenza Virus Vaccine (Pooled)|One injection of the investigational influenza virus vaccine (all lots pooled)
1078507|NCT00617851|O3|Outcome|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influenza virus vaccine
1082022|NCT00609973|E2|Reported Event|Placebo|Placebo bid
1078513|NCT00617851|O2|Outcome|Comparator Influenza Vaccine|One injection of the comparator influenza virus vaccine
1078514|NCT00617851|O1|Outcome|Influenza Virus Vaccine (Pooled)|One injection of the investigational influenza virus vaccine (all lots pooled)
1078515|NCT00617851|O5|Outcome|Comparator Influenza Vaccine|One injection of the comparator influenza virus vaccine
1078516|NCT00617851|O4|Outcome|Influenza Virus Vaccine (Pooled)|One injection of the investigational influenza virus vaccine (all lots pooled)
1078517|NCT00617851|O3|Outcome|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influenza virus vaccine
1078518|NCT00617851|O2|Outcome|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influenza virus vaccine
1078519|NCT00617851|O1|Outcome|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influenza virus vaccine
1078520|NCT00617851|O6|Outcome|Comparator Influenza Vaccine (Strain B)|One injection of the comparator influenza virus vaccine-Strain B
1078521|NCT00617851|O5|Outcome|Comparator Influenza Vaccine (Strain A/H3N2)|One injection of the comparator influenza virus vaccine-Strain A/H3N2
1078522|NCT00617851|O4|Outcome|Comparator Influenza Vaccine (Strain A/H1N1)|One injection of the comparator influenza virus vaccine-Strain A/H1N1
1078523|NCT00617851|O3|Outcome|Influenza Virus Vaccine (Strain B)|One injection of the investigational influenza virus vaccine-Strain B
1078524|NCT00617851|O2|Outcome|Influenza Virus Vaccine (Strain A/H3N2)|One injection of the investigational influenza virus vaccine-Strain A/H3N2
1078525|NCT00617851|O1|Outcome|Influenza Virus Vaccine (Strain A/H1N1)|One injection of the investigational influenza virus vaccine-Strain A/H1N1
1078526|NCT00617851|O3|Outcome|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influenza virus vaccine
1078527|NCT00617851|O2|Outcome|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influenza virus vaccine
1078528|NCT00617851|O1|Outcome|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influenza virus vaccine
1078529|NCT00617851|E2|Reported Event|Comparator Influenza Vaccine|One injection of the comparator influenza virus vaccine
1078530|NCT00617851|E1|Reported Event|Influenza Virus Vaccine (Pooled)|One injection of the investigational influenza virus vaccine (all lots pooled)
1078531|NCT00617773|B1|Baseline|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
1078532|NCT00617773|P1|Participant Flow|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
1078533|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
1078534|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
1078535|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
1078536|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
1078537|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
1078538|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
1078539|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
1078540|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
1078541|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
1078542|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
1078543|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
1078544|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
1078545|NCT00617773|E1|Reported Event|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
1078546|NCT00617708|B4|Baseline|Total|Total of all reporting groups
1078547|NCT00617708|B3|Baseline|Ph II: Erlotinib + Gemcitabine|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
1078548|NCT00617708|B2|Baseline|Ph II: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
1078549|NCT00617708|B1|Baseline|Ph I: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
1078550|NCT00617708|P3|Participant Flow|Ph II: Erlotinib + Gemcitabine|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
1078551|NCT00617708|P2|Participant Flow|Ph II: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
1078552|NCT00617708|P1|Participant Flow|Ph I: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
1078553|NCT00617708|O2|Outcome|Erlotinib + Gemcitabine|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
1078554|NCT00617708|O1|Outcome|Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
1078555|NCT00617708|O3|Outcome|Ph II: Erlotinib + Gemcitabine|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
1078556|NCT00617708|O2|Outcome|Ph II: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
1080185|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
1078557|NCT00617708|O1|Outcome|Ph I: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
1078558|NCT00617708|O2|Outcome|Erlotinib + Gemcitabine|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
1078559|NCT00617708|O1|Outcome|Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
1078560|NCT00617708|O1|Outcome|Ph I: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
1078561|NCT00617708|O2|Outcome|Erlotinib + Gemcitabine|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
1078562|NCT00617708|O1|Outcome|Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
1078563|NCT00617708|E3|Reported Event|Ph II: Erlotinib + Gemcitabine|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
1078564|NCT00617708|E2|Reported Event|Ph II: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
1078565|NCT00617708|E1|Reported Event|Ph I: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
1078566|NCT00617669|B3|Baseline|Total|Total of all reporting groups
1078567|NCT00617669|B2|Baseline|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
1078568|NCT00617669|B1|Baseline|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
1078569|NCT00617669|P2|Participant Flow|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
1078570|NCT00617669|P1|Participant Flow|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
1078571|NCT00617669|O2|Outcome|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
1078572|NCT00617669|O1|Outcome|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
1078573|NCT00617669|O2|Outcome|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
1078574|NCT00617669|O1|Outcome|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
1078575|NCT00617669|O2|Outcome|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
1078576|NCT00617669|O1|Outcome|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
1078577|NCT00617669|O2|Outcome|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
1078578|NCT00617669|O1|Outcome|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
1078579|NCT00617669|O2|Outcome|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
1078580|NCT00617669|O1|Outcome|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
1078581|NCT00617669|O2|Outcome|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
1078582|NCT00617669|O1|Outcome|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
1078583|NCT00617669|O2|Outcome|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
1078584|NCT00617669|O1|Outcome|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
1078585|NCT00617669|O2|Outcome|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
1078586|NCT00617669|O1|Outcome|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
1078587|NCT00617669|E2|Reported Event|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
1078588|NCT00617669|E1|Reported Event|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
1078589|NCT00617604|B3|Baseline|Total|Total of all reporting groups
1078590|NCT00617604|B2|Baseline|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
1078591|NCT00617604|B1|Baseline|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
1078592|NCT00617604|P2|Participant Flow|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
1078593|NCT00617604|P1|Participant Flow|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
1078594|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
1078595|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
1078664|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
1080186|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
1078596|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
1078597|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
1078598|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
1078599|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
1078600|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
1078601|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
1078602|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
1078603|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
1078604|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
1078605|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
1078606|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
1078607|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
1078608|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
1078609|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
1078610|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
1078611|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
1078612|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
1078613|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
1078614|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
1078615|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
1078616|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
1078617|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
1078618|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
1078665|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
1078619|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
1078620|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
1078621|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
1078622|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
1078623|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
1078624|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
1078625|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
1078626|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
1078627|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
1078628|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
1078629|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
1078630|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
1078631|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
1078632|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
1078633|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
1078634|NCT00617604|E2|Reported Event|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
1078635|NCT00617604|E1|Reported Event|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
1078636|NCT00617591|B1|Baseline|Induction and Maintenance Therapy|"Induction Phase Followed by Maintenance Therapy.~Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and PLD 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.~At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.~Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description."
1078637|NCT00617591|P1|Participant Flow|Induction and Maintenance Therapy|"Induction Phase Followed by Maintenance Therapy.~Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.~At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.~Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description."
1078638|NCT00617591|O1|Outcome|Induction at Initial Full Dose|"Induction Phase for First 29 Participants~Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m^2 intravenously on day 1."
1078666|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
1078667|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
1078668|NCT00617461|O4|Outcome|GEn 3600 mg in Second Intervention Period|GEn 3600 mg daily in second intervention period
1078669|NCT00617461|O3|Outcome|GEn 1200 mg in Second Intervention Period|GEn 1200 mg daily in second intervention period
1078639|NCT00617591|O1|Outcome|Induction and Maintenance Therapy|"Induction Phase Followed by Maintenance Therapy.~Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.~At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.~Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description."
1078640|NCT00617591|O1|Outcome|Induction and Maintenance Therapy|"Induction Phase Followed by Maintenance Therapy.~Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.~At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.~Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description."
1078641|NCT00617591|O1|Outcome|Induction and Maintenance Therapy|"Induction Phase Followed by Maintenance Therapy.~Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.~At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.~Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description."
1078642|NCT00617591|O1|Outcome|Induction and Maintenance Therapy|"Induction Phase Followed by Maintenance Therapy.~Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.~At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.~Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description."
1078643|NCT00617591|E1|Reported Event|Induction and Maintenance Therapy|"Induction Phase Followed by Maintenance Therapy.~Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and PLD 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.~At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.~Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description."
1078644|NCT00617461|B1|Baseline|All Participants in the Intent-to-Treat Population|All randomized participants who took at least one dose of study drug and had at least one post-baseline efficacy assessment, summarized independent of treatment sequence.
1078645|NCT00617461|P2|Participant Flow|GEn 3600 mg/Day Followed by GEn 1200 mg/Day|GEn 3600 mg/day administered for 28 days, followed by a 4-day crossover period during which participants received GEn 2400 mg/day. After the crossover period, participants switched to a dose of 1200 mg/day for 28 days. After completion of the second treatment period, participants entered a down-titration period in which they received 2400 mg/day for 2 days, followed by 1200 mg/day for 2 days, followed by 600 mg/day for 2 days.
1078646|NCT00617461|P1|Participant Flow|GEn 1200 mg/Day Followed by GEn 3600 mg/Day|Gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, 1200 mg/day administered for 28 days, followed by a 4-day crossover period during which participants received GEn 2400 mg/day. After the crossover period, participants switched to a dose of 3600 mg/day for 28 days. After completion of the second treatment period, participants entered a down-titration period in which they received 1200 mg/day for 3 days, followed by 600 mg/ day for 3 days.
1078647|NCT00617461|O3|Outcome|Gabapentin 1800 mg|PK population from Gabapentin 1800 mg Baseline Treatment period
1078648|NCT00617461|O2|Outcome|GEn 3600 mg|PK population from GEn 3600 mg treatment daily from either first intervention period or second intervention period
1078649|NCT00617461|O1|Outcome|GEn 1200 mg|PK population from GEn 1200 mg treatment daily from either first intervention period or second intervention period
1078650|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
1078651|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
1078652|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
1078653|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
1078654|NCT00617461|O4|Outcome|GEn 3600 mg in Second Intervention Period|GEn 3600 mg daily in second intervention period
1078655|NCT00617461|O3|Outcome|GEn 1200 mg in Second Intervention Period|GEn 1200 mg daily in second intervention period
1078656|NCT00617461|O2|Outcome|GEn 3600 mg in First Intervention Period|GEn 3600 mg daily in first intervention period
1078657|NCT00617461|O1|Outcome|GEn 1200 mg in First Intervention Period|GEn 1200 mg daily in first intervention period
1078658|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
1078659|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
1078660|NCT00617461|O4|Outcome|GEn 3600 mg in Second Intervention Period|GEn 3600 mg daily either in second intervention period
1078661|NCT00617461|O3|Outcome|GEn 1200 mg in Second Intervention Period|GEn 1200 mg daily in second intervention period
1078662|NCT00617461|O2|Outcome|GEn 3600 mg in First Intervention Period|GEn 3600 mg daily in first intervention period
1078663|NCT00617461|O1|Outcome|GEn 1200 mg in First Intervention Period|GEn 1200 mg daily in first intervention period
1078670|NCT00617461|O2|Outcome|GEn 3600 mg in First Intervention Period|GEn 3600 mg daily in first intervention period
1078671|NCT00617461|O1|Outcome|GEn 1200 mg in First Intervention Period|GEn 1200 mg daily in first intervention period
1078672|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
1078673|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
1078674|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
1078675|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
1078676|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
1078677|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
1078678|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
1078679|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
1078680|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
1078681|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
1078682|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
1078683|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
1078684|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
1078685|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
1078686|NCT00617461|O4|Outcome|GEn 3600 mg in Second Interevention Period|GEn 3600 mg daily in second intervention period only
1078687|NCT00617461|O3|Outcome|GEn 1200 mg in Second Intervention Period|GEn 1200 mg daily in second intervention period only
1078688|NCT00617461|O2|Outcome|GEn 3600 mg in First Intervention Period|GEn 3600 mg daily in first intervention period only
1078689|NCT00617461|O1|Outcome|GEn 1200 mg in First Intervention Period|GEn 1200 mg daily in first intervention period only
1078690|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
1078691|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
1078692|NCT00617461|E6|Reported Event|Overall GEn|All participants receiving GEn in any treatment period
1078693|NCT00617461|E5|Reported Event|Down-Titration Period|Participants down- titrated from GEn 3600 mg/day by taking 2400 mg/day for 2 days, followed by 1200 mg/day for 2 days, followed by 600 mg/day for 2 days before ending the assigned treatment. Participants down- titrated from GEn 1200 mg/day by taking 1200 mg/day for 3 days, followed by 600 mg/day for 3 days before ending the assigned treatment.
1078694|NCT00617461|E4|Reported Event|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
1078695|NCT00617461|E3|Reported Event|Crossover GEn 2400 mg|GEn 2400 mg daily during 4-day crossover period in between the first intervention period and the second intervention period
1078696|NCT00617461|E2|Reported Event|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
1078697|NCT00617461|E1|Reported Event|Baseline Gabapentin 1800 mg|Gabapentin 1800 mg daily for 2 weeks before randomization. Only includes participants who were subsequently randomized.
1078698|NCT00617409|B4|Baseline|Total|Total of all reporting groups
1078699|NCT00617409|B3|Baseline|Arm C - Experimental|Experimental: Ad.p53-DC vaccines + ATRA + Second Line Chemo
1078700|NCT00617409|B2|Baseline|Arm B - Experimental|Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy
1078701|NCT00617409|B1|Baseline|Arm A - Active Comparator|Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy
1078702|NCT00617409|P3|Participant Flow|Ad.p53-DC Vaccines + ATRA|Arm C - Experimental: Ad.p53-DC vaccines + All -trans Retinoic Acid (ATRA) + Second Line Chemo
1078703|NCT00617409|P2|Participant Flow|Ad.p53-DC Vaccines|Arm B - Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy
1078704|NCT00617409|P1|Participant Flow|Standard of Care|Arm A - Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy
1078705|NCT00617409|O3|Outcome|Ad.p53-DC Vaccines + ATRA|Arm C - Experimental: Ad.p53-DC vaccines + ATRA + Second Line Chemo
1078706|NCT00617409|O2|Outcome|Ad.p53-DC Vaccines|Arm B - Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy
1078707|NCT00617409|O1|Outcome|Standard of Care|Arm A - Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy
1078708|NCT00617409|O3|Outcome|Ad.p53-DC Vaccines + ATRA|Arm C - Experimental: Ad.p53-DC vaccines + All -trans Retinoic Acid (ATRA) + Second Line Chemo
1078709|NCT00617409|O2|Outcome|Ad.p53-DC Vaccines|Arm B - Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy
1078710|NCT00617409|O1|Outcome|Standard of Care|Arm A - Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy
1078711|NCT00617409|E3|Reported Event|Arm C - Experimental|Experimental: Ad.p53-DC vaccines + ATRA + Second Line Chemo
1078712|NCT00617409|E2|Reported Event|Arm B - Experimental|Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy
1078713|NCT00617409|E1|Reported Event|Arm A - Active Comparator|Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy
1078714|NCT00617396|B1|Baseline|Quetiapine ( 50mg/Day -100mg/Day)|There is only one group. All Subjects begin with a dose quetiapine of 50mg for 2 weeks, increasing to 100 mg for the remainder of the study. (9 weeks total) 25 subjects were enrolled in this group.
1078715|NCT00617396|P1|Participant Flow|Quetiapine ( 50mg/Day -100mg/Day)|There is only one group. All Subjects begin with a dose quetiapine of 50 mg for 2 weeks, increasing to 100 mg for the remainder of the study. 25 subjects were enrolled in this group.
1078716|NCT00617396|O1|Outcome|Quetiapine ( 50mg/Day -100mg/Day)|There is only one group. All Subject begin with a dose quetiapine of 50mg for 2 weeks, increasing to 100 mg for the remainder of the study. (9 weeks total)30 subjects were enrolled in this group.
1078717|NCT00617396|E1|Reported Event|Quetiapine ( 50mg/Day -100mg/Day)|There is only one group. All Subject begin with a dose Quetiapine of 50 mg for 2 weeks, increasing to 100 mg for the remainder of the study. (9 weeks total)29 subjects were enrolled in this group.
1078718|NCT00617357|B1|Baseline|One Arm|Strattice Reconstructive Tissue Matrix
1078719|NCT00617357|P1|Participant Flow|Strattice Tissue Matrix|
1078720|NCT00617357|O1|Outcome|Strattice Reconstructive Tissue Matrix|"Subjects implanted with Strattice Reconstructive Tissue Matrix in the repair of infected or contaminated hernias.~LTM (Strattice Reconstructive Tissue Matrix): Surgical mesh"
1078721|NCT00617357|O1|Outcome|Strattice Reconstructive Tissue Matrix|"Subjects implanted with Strattice Reconstructive Tissue Matrix in the repair of infected or contaminated hernias.~LTM (Strattice Reconstructive Tissue Matrix): Surgical mesh"
1078722|NCT00617357|O1|Outcome|Strattice Reconstructive Tissue Matrix|"Subjects implanted with Strattice Reconstructive Tissue Matrix in the repair of infected or contaminated hernias.~LTM (Strattice Reconstructive Tissue Matrix): Surgical mesh"
1078723|NCT00617357|O1|Outcome|Strattice Reconstructive Tissue Matrix|"Subjects implanted with Strattice Reconstructive Tissue Matrix in the repair of infected or contaminated hernias.~LTM (Strattice Reconstructive Tissue Matrix): Surgical mesh"
1078724|NCT00617357|O1|Outcome|Strattice Reconstructive Tissue Matrix|"Subjects implanted with Strattice Reconstructive Tissue Matrix in the repair of infected or contaminated hernias.~LTM (Strattice Reconstructive Tissue Matrix): Surgical mesh"
1078725|NCT00617357|O1|Outcome|Strattice Reconstructive Tissue Matrix|"Subjects implanted with Strattice Reconstructive Tissue Matrix in the repair of infected or contaminated hernias.~LTM (Strattice Reconstructive Tissue Matrix): Surgical mesh"
1078726|NCT00617357|O1|Outcome|One Arm|Strattice Reconstructive Tissue Matrix
1078727|NCT00617357|E1|Reported Event|Strattice|
1078728|NCT00617305|B4|Baseline|Total|Total of all reporting groups
1078729|NCT00617305|B3|Baseline|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i
1078730|NCT00617305|B2|Baseline|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i
1078731|NCT00617305|B1|Baseline|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i)
1078732|NCT00617305|P3|Participant Flow|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i
1078733|NCT00617305|P2|Participant Flow|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i
1078734|NCT00617305|P1|Participant Flow|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i)
1078735|NCT00617305|O2|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
1078736|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
1078737|NCT00617305|O2|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
1078738|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
1078739|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
1078740|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
1078741|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
1078742|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
1078743|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
1078744|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
1078745|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
1078746|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
1078747|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
1078748|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
1078749|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
1078750|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
1078751|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
1078752|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
1078753|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
1078754|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
1078755|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
1078756|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
1078757|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
1078758|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
1078759|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
1078760|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
1078761|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
1078762|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
1078763|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
1078764|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
1078765|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
1078766|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
1078767|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
1078768|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
1078769|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
1078770|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
1078771|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
1078772|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
1078773|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
1078774|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
1078845|NCT00617240|B2|Baseline|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
1080187|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
1078775|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
1078776|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
1078777|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
1078778|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
1078779|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
1078780|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
1078781|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
1078782|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
1078783|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
1078784|NCT00617305|E3|Reported Event|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i
1078785|NCT00617305|E2|Reported Event|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i
1078786|NCT00617305|E1|Reported Event|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i)
1078787|NCT00617279|B3|Baseline|Total|Total of all reporting groups
1078788|NCT00617279|B2|Baseline|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
1078789|NCT00617279|B1|Baseline|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
1078790|NCT00617279|P2|Participant Flow|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
1078791|NCT00617279|P1|Participant Flow|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
1078792|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
1078793|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
1078794|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
1078795|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
1078811|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
1082023|NCT00609973|E1|Reported Event|Cipro|Ciprofloxacin 500 mg bid
1078847|NCT00617240|P2|Participant Flow|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
1078848|NCT00617240|P1|Participant Flow|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
1078796|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
1078797|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
1078798|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
1078799|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
1078800|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
1078801|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
1078802|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
1078803|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
1078804|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
1078805|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
1078806|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
1078807|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
1078808|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
1078809|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
1078810|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
1078812|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
1078813|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
1078814|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
1078815|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
1078816|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
1078817|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
1078818|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
1078819|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
1078820|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
1078821|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
1078822|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
1078823|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
1078824|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
1078825|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
1078826|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
1078827|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
1078828|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
1078829|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
1078830|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
1078831|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
1078832|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
1078833|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
1078834|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
1078835|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
1078836|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
1078837|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
1078838|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
1078839|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
1078840|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
1078841|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
1078842|NCT00617279|E2|Reported Event|Disadvantaged Autologous Vein Graft|Disadvantaged Autologous Vein Graft
1078843|NCT00617279|E1|Reported Event|GORE PROPATEN Vascular Graft|GORE PROPATEN Vascular Graft
1078844|NCT00617240|B3|Baseline|Total|Total of all reporting groups
1084981|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
1078849|NCT00617240|O2|Outcome|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
1078850|NCT00617240|O1|Outcome|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
1078851|NCT00617240|O2|Outcome|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
1078852|NCT00617240|O1|Outcome|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
1078853|NCT00617240|O2|Outcome|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
1078854|NCT00617240|O1|Outcome|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
1078855|NCT00617240|O2|Outcome|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
1078856|NCT00617240|O1|Outcome|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
1078857|NCT00617240|O2|Outcome|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
1078858|NCT00617240|O1|Outcome|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
1078859|NCT00617240|O2|Outcome|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
1078860|NCT00617240|O1|Outcome|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
1078861|NCT00617240|O2|Outcome|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
1078862|NCT00617240|O1|Outcome|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
1078863|NCT00617240|E2|Reported Event|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
1078864|NCT00617240|E1|Reported Event|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
1078865|NCT00617201|B3|Baseline|Total|Total of all reporting groups
1078866|NCT00617201|B2|Baseline|Atomoxetine|Atomoxetine (80 mg/day)
1078867|NCT00617201|B1|Baseline|Placebo|Matched placebo
1078868|NCT00617201|P2|Participant Flow|Matched Placebo|"Matched Placebo~placebo : Once daily oral dosing - matched placebo"
1078869|NCT00617201|P1|Participant Flow|Atomoxetine (80 mg/Day)|"Active drug~atomoxetine : Once daily oral dosing"
1078870|NCT00617201|O2|Outcome|Atomoxetine|Atomoxetine (80 mg/day)
1078871|NCT00617201|O1|Outcome|Placebo|Matched placebo
1078872|NCT00617201|O2|Outcome|Atomoxetine|80 mg/day (after intial 4-day run up)
1078873|NCT00617201|O1|Outcome|Placebo|Matched Placebo
1078874|NCT00617201|E2|Reported Event|Matched Placebo|"Matched Placebo~placebo : Once daily oral dosing - matched placebo"
1078875|NCT00617201|E1|Reported Event|Atomoxetine (80 mg/Day)|"Active drug~atomoxetine : Once daily oral dosing"
1078876|NCT00617188|B1|Baseline|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
1078877|NCT00617188|P1|Participant Flow|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
1078878|NCT00617188|O1|Outcome|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
1078879|NCT00617188|O1|Outcome|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
1078880|NCT00617188|O1|Outcome|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
1078881|NCT00617188|O1|Outcome|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
1078882|NCT00617188|O1|Outcome|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
1078883|NCT00617188|O1|Outcome|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
1078884|NCT00617188|E1|Reported Event|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
1078885|NCT00617175|B3|Baseline|Total|Total of all reporting groups
1078886|NCT00617175|B2|Baseline|Long NID|Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia
1078887|NCT00617175|B1|Baseline|Short NID|Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia
1078888|NCT00617175|P2|Participant Flow|Long NID|Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia
1078889|NCT00617175|P1|Participant Flow|Short NID|Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia
1078890|NCT00617175|O2|Outcome|NID 30/40|Prolonged number of interval to detect ventricular arrhythmias
1078891|NCT00617175|O1|Outcome|NID 18/24|standard number of interval to detect ventricular arrhythmias
1078892|NCT00617175|E2|Reported Event|Long NID|Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia
1078893|NCT00617175|E1|Reported Event|Short NID|Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia
1078894|NCT00617123|B3|Baseline|Total|Total of all reporting groups
1078895|NCT00617123|B2|Baseline|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
1078896|NCT00617123|B1|Baseline|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
1078897|NCT00617123|P2|Participant Flow|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
1078898|NCT00617123|P1|Participant Flow|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
1078899|NCT00617123|O2|Outcome|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
1078900|NCT00617123|O1|Outcome|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
1078901|NCT00617123|O2|Outcome|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
1078902|NCT00617123|O1|Outcome|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
1078903|NCT00617123|O2|Outcome|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
1078904|NCT00617123|O1|Outcome|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
1078905|NCT00617123|O2|Outcome|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
1078906|NCT00617123|O1|Outcome|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
1078907|NCT00617123|O2|Outcome|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
1078908|NCT00617123|O1|Outcome|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
1078909|NCT00617123|E2|Reported Event|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
1078910|NCT00617123|E1|Reported Event|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
1078911|NCT00617097|B3|Baseline|Total|Total of all reporting groups
1078912|NCT00617097|B2|Baseline|Paracervical Block With Ketorolac and Lidocaine|Subjects who received pain control with paracervical block with 30mg (2mL) of ketorolac and 18mL of 1% lidocaine during first trimester surgical abortion
1078913|NCT00617097|B1|Baseline|Paracervical Block With Lidocaine|Subjects who received pain control with paracervical block with 18mL of 1% lidocaine and 2mL of saline during first trimester surgical abortion
1078914|NCT00617097|P2|Participant Flow|Paracervical Block With Ketorolac and Lidocaine|Subjects who received pain control of paracervical block with combined 30mg of ketorolac and 18mL of 1% lidocaine during first trimester surgical abortion
1078915|NCT00617097|P1|Participant Flow|Paracervical Block With Lidocaine|Subjects who received paracervical block with 18 mL of 1% lidocaine and 2 mL of saline for pain control during first trimester surgical abortion
1078916|NCT00617097|O2|Outcome|Paracervical Block With Ketorolac and Lidocaine|Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion
1078917|NCT00617097|O1|Outcome|Paracervical Block With Lidocaine|Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion
1078918|NCT00617097|O2|Outcome|Paracervical Block With Ketorolac and Lidocaine|Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion
1078919|NCT00617097|O1|Outcome|Paracervical Block With Lidocaine|Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion
1078920|NCT00617097|O2|Outcome|Paracervical Block With Ketorolac and Lidocaine|Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion
1078921|NCT00617097|O1|Outcome|Paracervical Block With Lidocaine|Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion
1078922|NCT00617097|O2|Outcome|Paracervical Block With Ketorolac and Lidocaine|Subjects who received pain control using paracervical block with 30mg (2mL) of ketorolac and 18mL of 1% lidocaine during first trimester surgical abortion
1078923|NCT00617097|O1|Outcome|Paracervical Block With Lidocaine|Subjects who received pain control using paracervical block with 18mL of 1% lidocaine and 2 mL of saline during first trimester surgical abortion
1078924|NCT00617097|E2|Reported Event|Paracervical Block With Ketorolac and Lidocaine|Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion
1078925|NCT00617097|E1|Reported Event|Paracervical Block With Lidocaine|Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion
1078926|NCT00617084|B3|Baseline|Total|Total of all reporting groups
1078927|NCT00617084|B2|Baseline|2. XIENCE V - 12-13 Months|Abbott Xience V - 12-13 Months
1078928|NCT00617084|B1|Baseline|1. Resolute - 12-13 Months|Medtronic Resolute - 12-13 Months
1078929|NCT00617084|P2|Participant Flow|2. XIENCE V - 12-13 Months|Abbott Xience V - 12-13 Months
1078930|NCT00617084|P1|Participant Flow|1. Resolute - 12-13 Months|Medtronic Resolute - 12-13 Months
1078931|NCT00617084|O2|Outcome|2. XIENCE V - 12-13 Months|Abbott Xience V - 12-13 Months
1078932|NCT00617084|O1|Outcome|1. Resolute - 12-13 Months|Medtronic Resolute - 12-13 Months
1078933|NCT00617084|O2|Outcome|2. XIENCE V - 12-13 Months|Abbott Xience V - 12-13 Months
1078934|NCT00617084|O1|Outcome|1. Resolute - 12-13 Months|Medtronic Resolute - 12-13 Months
1078935|NCT00617084|E2|Reported Event|2. XIENCE V - 12-13 Months|Abbott Xience V - 12-13 Months
1078936|NCT00617084|E1|Reported Event|1. Resolute - 12-13 Months|Medtronic Resolute - 12-13 Months
1078937|NCT00617058|B4|Baseline|Total|Total of all reporting groups
1078938|NCT00617058|B3|Baseline|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
1078939|NCT00617058|B2|Baseline|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
1078940|NCT00617058|B1|Baseline|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
1078941|NCT00617058|P3|Participant Flow|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
1079078|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
1078942|NCT00617058|P2|Participant Flow|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
1078943|NCT00617058|P1|Participant Flow|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
1078944|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
1078945|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
1078946|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
1078947|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
1078948|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
1078949|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
1078950|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
1078951|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
1078952|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
1078953|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
1078954|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
1078955|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
1078956|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
1078957|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
1078958|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
1078959|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
1078960|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
1078961|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
1079046|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1084982|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
1078962|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
1078963|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
1078964|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
1078965|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
1078966|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
1078967|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
1078968|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
1078969|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
1078970|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
1078971|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
1078972|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
1078973|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
1078974|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
1078975|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
1078976|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
1078977|NCT00617058|E3|Reported Event|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
1078978|NCT00617058|E2|Reported Event|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
1078979|NCT00617058|E1|Reported Event|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
1078980|NCT00616967|B3|Baseline|Total|Total of all reporting groups
1078981|NCT00616967|B2|Baseline|Vorinostat (Arm 2)|"Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~vorinostat: Given orally"
1078982|NCT00616967|B1|Baseline|Placebo (Arm 1)|"Patients receive carboplatin IV and paclitaxel albumin-stabilized nanoparticle formulation IV on day 1 and an oral placebo on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~placebo: Given orally"
1079137|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
1078983|NCT00616967|P3|Participant Flow|Vorinostat (Arm II)|"Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~vorinostat: Given orally"
1078984|NCT00616967|P2|Participant Flow|Placebo (Arm I)|"Patients receive carboplatin IV and paclitaxel albumin-stabilized nanoparticle formulation IV on day 1 and an oral placebo on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~placebo: Given orally"
1078985|NCT00616967|P1|Participant Flow|Run-in Phase (Arm 0)|"Phase 0 - To confirm safety and dosing prior to moving to randomized phase 2 portion (Arms 1 and 2).~Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~vorinostat: Given orally"
1078986|NCT00616967|O2|Outcome|Non-Responders|Pooled data from participants who did not receive a pathologic complete response across arms.
1078987|NCT00616967|O1|Outcome|Responders|Pooled data from participants who received a pathologic complete response across arms.
1078988|NCT00616967|O2|Outcome|Arm II|"Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~vorinostat: Given orally"
1078989|NCT00616967|O1|Outcome|Arm I|"Patients receive carboplatin IV and paclitaxel albumin-stabilized nanoparticle formulation IV on day 1 and an oral placebo on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~placebo: Given orally"
1078990|NCT00616967|E3|Reported Event|Arm II|"Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~vorinostat: Given orally"
1078991|NCT00616967|E2|Reported Event|Arm I|"Patients receive carboplatin IV and paclitaxel albumin-stabilized nanoparticle formulation IV on day 1 and an oral placebo on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~placebo: Given orally"
1078992|NCT00616967|E1|Reported Event|Run-in Phase (Arm 0)|"Phase 0 - To confirm safety and dosing prior to moving to randomized phase 2 portion (Arms 1 and 2).~Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~vorinostat: Given orally~Events summarized in this arm are those that met 5% reporting threshold in Arms I and II."
1078993|NCT00616928|B5|Baseline|Total|Total of all reporting groups
1078994|NCT00616928|B4|Baseline|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1078995|NCT00616928|B3|Baseline|Influenza A (H5N1) >64Y Group|Influenza A (H5N1) >64Y Group Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1078996|NCT00616928|B2|Baseline|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1078997|NCT00616928|B1|Baseline|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1078998|NCT00616928|P4|Participant Flow|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1078999|NCT00616928|P3|Participant Flow|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079000|NCT00616928|P2|Participant Flow|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079001|NCT00616928|P1|Participant Flow|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079002|NCT00616928|O2|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079003|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1084983|NCT00603525|O1|Outcome|Placebo|
1079004|NCT00616928|O2|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079005|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079006|NCT00616928|O4|Outcome|Placebo ˃ 64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079007|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079008|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079009|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079010|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged >64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079011|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079012|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079013|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079014|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079015|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079016|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079017|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079018|NCT00616928|O4|Outcome|Placebo ˃ 64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079019|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079020|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079021|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079022|NCT00616928|O4|Outcome|Placebo >60Y Group|Subjects aged > 60 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079023|NCT00616928|O3|Outcome|Influenza A (H5N1) >60Y Group|Subjects aged >60 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079024|NCT00616928|O2|Outcome|Placebo 18-60Y Group|Subjects aged 18-60 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079076|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
1079025|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-60Y Group|Subjects aged 18-60 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079026|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079027|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079028|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079029|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079030|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079031|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079032|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079033|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079034|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079035|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079036|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079037|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079038|NCT00616928|O6|Outcome|Placebo Group|Pooled group of subjects aged >18 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079039|NCT00616928|O5|Outcome|Influenza A (H5N1) Group|Pooled group of subjects aged >18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079040|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079041|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079042|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079043|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079044|NCT00616928|O6|Outcome|Placebo Group|Pooled group of subjects aged >18 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079045|NCT00616928|O5|Outcome|Influenza A (H5N1) Group|Pooled group of subjects aged >18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079077|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
1079047|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079048|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079049|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm
1079050|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079051|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079052|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079053|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm
1079054|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079055|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079056|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079057|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079058|NCT00616928|E4|Reported Event|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079059|NCT00616928|E3|Reported Event|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079060|NCT00616928|E2|Reported Event|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079061|NCT00616928|E1|Reported Event|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
1079062|NCT00616902|B3|Baseline|Total|Total of all reporting groups
1079063|NCT00616902|B2|Baseline|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
1079064|NCT00616902|B1|Baseline|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
1079065|NCT00616902|P2|Participant Flow|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
1079066|NCT00616902|P1|Participant Flow|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
1079067|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
1079068|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
1079069|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
1079070|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
1079071|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
1079072|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
1079073|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
1079074|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
1079075|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
1084984|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
1079079|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
1079080|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
1079081|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
1079082|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
1079083|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
1079084|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
1079085|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
1079086|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
1079087|NCT00616902|E2|Reported Event|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
1079088|NCT00616902|E1|Reported Event|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
1079089|NCT00616772|B3|Baseline|Total|Total of all reporting groups
1079090|NCT00616772|B2|Baseline|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
1079091|NCT00616772|B1|Baseline|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
1079092|NCT00616772|P2|Participant Flow|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
1079093|NCT00616772|P1|Participant Flow|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
1079094|NCT00616772|O2|Outcome|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
1079095|NCT00616772|O1|Outcome|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
1079096|NCT00616772|O2|Outcome|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
1079097|NCT00616772|O1|Outcome|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
1079098|NCT00616772|O2|Outcome|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
1079099|NCT00616772|O1|Outcome|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
1079100|NCT00616772|O2|Outcome|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
1079101|NCT00616772|O1|Outcome|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
1079102|NCT00616772|O2|Outcome|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
1079103|NCT00616772|O1|Outcome|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
1079104|NCT00616772|E2|Reported Event|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
1079105|NCT00616772|E1|Reported Event|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
1079106|NCT00616759|B3|Baseline|Total|Total of all reporting groups
1079107|NCT00616759|B2|Baseline|6 ECTs Where Seizure Was Shortened by Propofol|ECT-induced seizures terminated with propofol
1079108|NCT00616759|B1|Baseline|Series of 6 ECTs Performed With Standard Technique|Electroconvulsive Therapy (ECT) as usual
1079109|NCT00616759|P2|Participant Flow|6 ECTs Where Seizure Was Shortened by Propofol|ECT-induced seizures terminated with propofol
1079110|NCT00616759|P1|Participant Flow|Series of 6 ECTs Performed With Standard Technique|Electroconvulsive Therapy (ECT) as usual
1079111|NCT00616759|O2|Outcome|6 ECTs Where Seizure Was Shortened by Propofol|ECT-induced seizures terminated with propofol
1079112|NCT00616759|O1|Outcome|Series of 6 ECTs Performed With Standard Technique|Electroconvulsive Therapy (ECT) as usual
1079113|NCT00616759|E2|Reported Event|6 ECTs Where Seizure Was Shortened by Propofol|ECT-induced seizures terminated with propofol
1079114|NCT00616759|E1|Reported Event|Series of 6 ECTs Performed With Standard Technique|Electroconvulsive Therapy (ECT) as usual
1079115|NCT00616655|B4|Baseline|Total|Total of all reporting groups
1079116|NCT00616655|B3|Baseline|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
1079117|NCT00616655|B2|Baseline|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
1079118|NCT00616655|B1|Baseline|Placebo Arm|Placebo
1079119|NCT00616655|P3|Participant Flow|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
1079120|NCT00616655|P2|Participant Flow|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
1079121|NCT00616655|P1|Participant Flow|Placebo Arm|Placebo
1079122|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
1079123|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
1079124|NCT00616655|O1|Outcome|Placebo Arm|Placebo
1079125|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
1079126|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
1079127|NCT00616655|O1|Outcome|Placebo Arm|Placebo
1079128|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
1079129|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
1079130|NCT00616655|O1|Outcome|Placebo Arm|Placebo
1079131|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
1079132|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
1079133|NCT00616655|O1|Outcome|Placebo Arm|Placebo
1079134|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
1079140|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
1079143|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
1079144|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
1079145|NCT00616655|O1|Outcome|Placebo Arm|Placebo
1079146|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
1079147|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
1079148|NCT00616655|O1|Outcome|Placebo Arm|Placebo
1079149|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
1079150|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
1079151|NCT00616655|O1|Outcome|Placebo Arm|Placebo
1079152|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
1079153|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
1079154|NCT00616655|O1|Outcome|Placebo Arm|Placebo
1079155|NCT00616655|E3|Reported Event|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
1079156|NCT00616655|E2|Reported Event|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
1079157|NCT00616655|E1|Reported Event|Placebo Arm|Placebo
1079158|NCT00616642|B3|Baseline|Total|Total of all reporting groups
1079159|NCT00616642|B2|Baseline|Group 2 (Non-secreting Macroadenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 12 months in the absence of disease progression or unacceptable toxicity.~rosiglitazone maleate : Given orally"
1079160|NCT00616642|B1|Baseline|Group 1 (ACTH-secreting Adenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 6 months in the absence of disease progression or unacceptable toxicity.~rosiglitazone maleate : Given orally"
1079161|NCT00616642|P2|Participant Flow|Group 2 (Non-secreting Macroadenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 12 months in the absence of disease progression or unacceptable toxicity.~rosiglitazone maleate : Given orally"
1079162|NCT00616642|P1|Participant Flow|Group 1 (ACTH-secreting Adenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 6 months in the absence of disease progression or unacceptable toxicity.~rosiglitazone maleate : Given orally"
1079163|NCT00616642|O2|Outcome|Group 2 (Non-secreting Macroadenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 12 months in the absence of disease progression or unacceptable toxicity.~rosiglitazone maleate : Given orally"
1079164|NCT00616642|O1|Outcome|Group 1 (ACTH-secreting Adenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 6 months in the absence of disease progression or unacceptable toxicity.~rosiglitazone maleate : Given orally"
1079165|NCT00616642|E2|Reported Event|Group 2 (Non-secreting Macroadenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 12 months in the absence of disease progression or unacceptable toxicity.~rosiglitazone maleate : Given orally"
1079166|NCT00616642|E1|Reported Event|Group 1 (ACTH-secreting Adenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 6 months in the absence of disease progression or unacceptable toxicity.~rosiglitazone maleate : Given orally"
1079167|NCT00616629|B6|Baseline|Total|Total of all reporting groups
1079168|NCT00616629|B5|Baseline|Placebo|Corresponding placebo
1079169|NCT00616629|B4|Baseline|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
1079170|NCT00616629|B3|Baseline|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
1079171|NCT00616629|B2|Baseline|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
1079172|NCT00616629|B1|Baseline|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
1079173|NCT00616629|P5|Participant Flow|Placebo|Corresponding placebo
1079174|NCT00616629|P4|Participant Flow|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
1079175|NCT00616629|P3|Participant Flow|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
1079176|NCT00616629|P2|Participant Flow|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
1079177|NCT00616629|P1|Participant Flow|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
1079178|NCT00616629|O5|Outcome|Placebo|Corresponding placebo
1079179|NCT00616629|O4|Outcome|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
1079180|NCT00616629|O3|Outcome|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
1079181|NCT00616629|O2|Outcome|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
1079182|NCT00616629|O1|Outcome|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
1079183|NCT00616629|O5|Outcome|Placebo|Corresponding placebo
1079184|NCT00616629|O4|Outcome|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
1079185|NCT00616629|O3|Outcome|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
1079186|NCT00616629|O2|Outcome|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
1079187|NCT00616629|O1|Outcome|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
1079188|NCT00616629|O5|Outcome|Placebo|Corresponding placebo
1080197|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
1079189|NCT00616629|O4|Outcome|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
1079190|NCT00616629|O3|Outcome|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
1079191|NCT00616629|O2|Outcome|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
1079192|NCT00616629|O1|Outcome|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
1079193|NCT00616629|O5|Outcome|Placebo|Corresponding placebo
1079194|NCT00616629|O4|Outcome|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
1079195|NCT00616629|O3|Outcome|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
1079196|NCT00616629|O2|Outcome|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
1079197|NCT00616629|O1|Outcome|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
1079198|NCT00616629|O5|Outcome|Placebo|Corresponding placebo
1079199|NCT00616629|O4|Outcome|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
1079200|NCT00616629|O3|Outcome|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
1079201|NCT00616629|O2|Outcome|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
1079202|NCT00616629|O1|Outcome|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
1079203|NCT00616629|O5|Outcome|Placebo|Corresponding placebo
1079204|NCT00616629|O4|Outcome|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
1079205|NCT00616629|O3|Outcome|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
1079206|NCT00616629|O2|Outcome|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
1079207|NCT00616629|O1|Outcome|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
1079208|NCT00616629|O5|Outcome|Placebo|Corresponding placebo
1079209|NCT00616629|O4|Outcome|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
1079210|NCT00616629|O3|Outcome|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
1079211|NCT00616629|O2|Outcome|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
1079212|NCT00616629|O1|Outcome|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
1079213|NCT00616629|E5|Reported Event|Placebo|Corresponding placebo
1079214|NCT00616629|E4|Reported Event|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
1079215|NCT00616629|E3|Reported Event|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
1079216|NCT00616629|E2|Reported Event|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
1079217|NCT00616629|E1|Reported Event|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
1079218|NCT00616603|B4|Baseline|Total|Total of all reporting groups
1079219|NCT00616603|B3|Baseline|Group C|Subjects in Group C will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV (8mg)of Dexamethasone.
1079220|NCT00616603|B2|Baseline|Group B|Subjects in Group B will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 8mg Dexamethasone + 2ml IV of normal saline.
1079221|NCT00616603|B1|Baseline|Group A|This is the control arm and subjects in Group A will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV of normal saline.
1079222|NCT00616603|P3|Participant Flow|Group C|Subjects in Group C will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV (8mg)of Dexamethasone.
1079223|NCT00616603|P2|Participant Flow|Group B|Subjects in Group B will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 8mg Dexamethasone + 2ml IV of normal saline.
1079224|NCT00616603|P1|Participant Flow|Group A|This is the control arm and subjects in Group A will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV of normal saline.
1079225|NCT00616603|O3|Outcome|Group C|Subjects in Group C will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV (8mg)of Dexamethasone.
1079226|NCT00616603|O2|Outcome|Group B|Subjects in Group B will have 20ml of 0.2% Ropivacaine + 8mg Dexamethasone + 2ml of normal saline
1079227|NCT00616603|O1|Outcome|Group A|This is the control arm and subjects in Group A will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV of normal sali
1079228|NCT00616603|E3|Reported Event|Group C|Subjects in Group C will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV (8mg)of Dexamethasone.
1079229|NCT00616603|E2|Reported Event|Group A|This is the control arm and subjects in Group A will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV of normal saline.
1079230|NCT00616603|E1|Reported Event|Group B|Subjects in Group B will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 8mg Dexamethasone + 2ml IV of normal saline.
1079231|NCT00616577|B4|Baseline|Total|Total of all reporting groups
1079232|NCT00616577|B3|Baseline|Group LIA|"Group LIA (Local Infiltration After—control group) will receive local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site at the conclusion of surgery but before emergence from anesthesia.~Ropivacaine: local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site"
1079267|NCT00616421|O1|Outcome|MenACWY-CRM (1 Dose)|The Novartis MenACWY-CRM vaccine was administered by IM in children 6 to 10 years of age.
1079671|NCT00615017|P1|Participant Flow|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
1079268|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine (1 Dose)|The licensed meningococcal MenACWY polysaccharide vaccine was administered by IM in children 2 to 5 years of age.
1080198|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
1079233|NCT00616577|B2|Baseline|Group CA|"Group CA (Caudal After—control group) will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after completion of surgery but before emergence from anesthesia.~Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
1079234|NCT00616577|B1|Baseline|Group CB|"Subjects in this arm will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after induction of general anesthesia prior to surgical incision.~Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
1079235|NCT00616577|P3|Participant Flow|Group LIA|"Group LIA (Local Infiltration After—control group) will receive local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site at the conclusion of surgery but before emergence from anesthesia.~Ropivacaine: local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site"
1079236|NCT00616577|P2|Participant Flow|Group CA|"Group CA (Caudal After—control group) will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after completion of surgery but before emergence from anesthesia.~Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
1079237|NCT00616577|P1|Participant Flow|Group CB|"Subjects in this arm will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after induction of general anesthesia prior to surgical incision.~Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
1079238|NCT00616577|O3|Outcome|Group LIA|"Group LIA (Local Infiltration After—control group) will receive local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site at the conclusion of surgery but before emergence from anesthesia.~Ropivacaine: local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site"
1079239|NCT00616577|O2|Outcome|Group CA|"Group CA (Caudal After—control group) will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after completion of surgery but before emergence from anesthesia.~Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
1079240|NCT00616577|O1|Outcome|Group CB|"Subjects in this arm will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after induction of general anesthesia prior to surgical incision.~Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
1079241|NCT00616577|E3|Reported Event|Group LIA|"Group LIA (Local Infiltration After—control group) will receive local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site at the conclusion of surgery but before emergence from anesthesia.~Ropivacaine: local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site"
1079242|NCT00616577|E2|Reported Event|Group CA|"Group CA (Caudal After—control group) will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after completion of surgery but before emergence from anesthesia.~Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
1079243|NCT00616577|E1|Reported Event|Group CB|"Subjects in this arm will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after induction of general anesthesia prior to surgical incision.~Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
1079244|NCT00616434|B3|Baseline|Total|Total of all reporting groups
1079245|NCT00616434|B2|Baseline|Placebo|Placebo IM injection twice weekly for 12 weeks
1079246|NCT00616434|B1|Baseline|Interferon Beta-1a|Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
1079247|NCT00616434|P2|Participant Flow|Placebo|Placebo IM injection twice weekly for 12 weeks
1079248|NCT00616434|P1|Participant Flow|Interferon Beta-1a|Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
1079249|NCT00616434|O2|Outcome|Placebo|Placebo IM injection twice weekly for 12 weeks
1079250|NCT00616434|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
1079251|NCT00616434|O2|Outcome|Placebo|Placebo IM injection twice weekly for 12 weeks
1079252|NCT00616434|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
1079253|NCT00616434|O2|Outcome|Placebo|Placebo IM injection twice weekly for 12 weeks
1079254|NCT00616434|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
1079255|NCT00616434|E2|Reported Event|Placebo|Placebo IM injection twice weekly for 12 weeks
1079256|NCT00616434|E1|Reported Event|Interferon Beta-1a|Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
1079257|NCT00616421|B4|Baseline|Total|Total of all reporting groups
1079258|NCT00616421|B3|Baseline|Licensed Polysaccharide Vaccine|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1.
1079259|NCT00616421|B2|Baseline|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) vaccine administered by intramuscular (IM) injection on study day1.
1079260|NCT00616421|B1|Baseline|MenACWY-CRM (2 Doses)|2 injections of the Novartis MenACWY-CRM vaccine administered on study days 1 and 61 in children 2 to 5 years of age.
1079261|NCT00616421|P3|Participant Flow|Licensed Polysaccharide Vaccine|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
1079262|NCT00616421|P2|Participant Flow|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) vaccine administered by intramuscular (IM) injection on study day 1
1079263|NCT00616421|P1|Participant Flow|MenACWY-CRM (2 Doses)|2 injections of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) vaccine administered by intramuscular (IM) injection on study days 1 and 61 in children 2 to 5 years of age
1079264|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine (1 Dose)|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
1079265|NCT00616421|O1|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
1079266|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine (1 Dose)|The licensed meningococcal MenACWY polysaccharide vaccine was administered by IM in children 6 to 10 years of age.
1079672|NCT00615017|O6|Outcome|Placebo|Placebo
1079269|NCT00616421|O1|Outcome|MenACWY-CRM (1 Dose)|The Novartis MenACWY-CRM vaccine was administered by IM in children 2 to 5 years of age.
1079270|NCT00616421|O2|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 2 to 5 years of age
1079271|NCT00616421|O1|Outcome|MenACWY-CRM (2 Doses)|2 injections of the Novartis MenACWY-CRM vaccine administered by IM on study days 1 and 61 in children 2 to 5 years of age
1079272|NCT00616421|O2|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 2 to 5 years of age
1079273|NCT00616421|O1|Outcome|MenACWY-CRM (2 Doses)|2 injections of the Novartis MenACWY-CRM vaccine administered by IM on study days 1 and 61 in children 2 to 5 years of age
1079274|NCT00616421|O2|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 2 to 5 years of age
1079275|NCT00616421|O1|Outcome|MenACWY-CRM (2 Doses)|2 injections of the Novartis MenACWY-CRM vaccine administered by IM on study days 1 and 61 in children 2 to 5 years of age
1079276|NCT00616421|O4|Outcome|Licensed Polysaccharide Vaccine (6 to 10 Yoa)|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered by IM on study day 1 in children 6 to 10 years of age
1079277|NCT00616421|O3|Outcome|MenACWY-CRM (6 to 10 Yoa)|1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 6 to 10 years of age.
1079278|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine (2 to 5 Yoa)|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered by IM on study day 1 in children 2 to 5 years of age
1079279|NCT00616421|O1|Outcome|MenACWY-CRM (2 to 5 Yoa)|1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 2 to 5 years of age.
1079280|NCT00616421|O4|Outcome|Licensed Polysaccharide Vaccine (6 to 10 Yoa)|1 injection of the licensed meningococcal ACWY polysaccharide-protein conjugate administered by IM on study day 1 in children 6 to 10 years of age.
1079281|NCT00616421|O3|Outcome|MenACWY-CRM (6 to 10 Yoa)|1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 6 to 10 years of age.
1079282|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine (2 to 5 Yoa)|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered by IM on study day 1 in children 2 to 5 years of age.
1079283|NCT00616421|O1|Outcome|MenACWY-CRM (2 to 5 Yoa)|1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 2 to 5 years of age.
1079284|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
1079285|NCT00616421|O1|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
1079286|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
1079287|NCT00616421|O1|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
1079288|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
1079289|NCT00616421|O1|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
1079290|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
1079291|NCT00616421|O1|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
1079292|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
1079293|NCT00616421|O1|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
1079294|NCT00616421|E5|Reported Event|Licensed Polysaccharide Vaccine_6 to 10 Years|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1 in children 6 to 10 years of age.
1079295|NCT00616421|E4|Reported Event|Licensed Polysaccharide Vaccine_2 to 5 Years|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1 in children 2 to 5 years of age.
1079296|NCT00616421|E3|Reported Event|MenACWY-CRM (1 Dose)_6 to 10 Years|1 injection of the Novartis MenACWY-CRM vaccine administered on study day 1 in children 6 to 10 years of age.
1079297|NCT00616421|E2|Reported Event|MenACWY-CRM (1 Dose)_2 to 5 Years|1 injection of the Novartis MenACWY-CRM vaccine administered on study day 1 in children 2 to 5 years of age.
1079298|NCT00616421|E1|Reported Event|MenACWY-CRM (2 Doses)|2 injections of the Novartis MenACWY-CRM vaccine administered by IM on study days 1 and 61 in children 2 to 5 years of age
1079299|NCT00616343|B1|Baseline|Zonisamide|Zonisamide: 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
1079300|NCT00616343|P1|Participant Flow|Zonisamide|Zonisamide: 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
1079301|NCT00616343|O1|Outcome|Zonisamide|Zonisamide: 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
1079302|NCT00616343|E1|Reported Event|Zonisamide|Zonisamide: 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
1079303|NCT00616239|B1|Baseline|20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream|Subjects randomized to have the right side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks.
1079304|NCT00616239|P1|Participant Flow|20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream|Subjects randomized to have the right side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks.
1079392|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1084985|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
1079394|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079305|NCT00616239|O1|Outcome|20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream|Subjects randomized to have the right side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks.
1079306|NCT00616239|E1|Reported Event|20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream|Subjects randomized to have the right side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks.
1079307|NCT00616200|B1|Baseline|Four Week Very Low Carbohydrate Diet|A Very Low Carbohydrate Diet was administered for four weeks. VLCD = <20g/day of carbohydrates
1079308|NCT00616200|P1|Participant Flow|Standard Diet Then Very Low Carbohydrate Diet|Two weeks of a carbohydrate rich diet was followed by four weeks of A Very Low Carbohydrate Diet. VLCD = <20g/day of carbohydrates
1079309|NCT00616200|O1|Outcome|Four Week Very Low Carbohydrate Diet|A Very Low Carbohydrate Diet was administered for four weeks. VLCD = <20g/day of carbohydrates
1079310|NCT00616200|O1|Outcome|Four Week Very Low Carbohydrate Diet|A Very Low Carbohydrate Diet was administered for four weeks. VLCD = <20g/day of carbohydrates
1079311|NCT00616200|O1|Outcome|Four Week Very Low Carbohydrate Diet|A Very Low Carbohydrate Diet was administered for four weeks. VLCD = <20g/day of carbohydrates
1079312|NCT00616200|E1|Reported Event|Four Week Very Low Carbohydrate Diet|A Very Low Carbohydrate Diet was administered for four weeks. VLCD = <20g/day of carbohydrates
1079313|NCT00616122|B1|Baseline|Sunitinib, Cyclophosphamide, and Methotrexate|Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment).
1079314|NCT00616122|P1|Participant Flow|Sunitinib, Cyclophosphamide, and Methotrexate|Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment).
1079315|NCT00616122|O1|Outcome|Sunitinib, Cyclophosphamide, and Methotrexate|Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment).
1079316|NCT00616122|O1|Outcome|Sunitinib, Cyclophosphamide, and Methotrexate|Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment).
1079317|NCT00616122|O1|Outcome|Sunitinib, Cyclophosphamide, and Methotrexate|Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment).
1079318|NCT00616122|O1|Outcome|Sunitinib, Cyclophosphamide, and Methotrexate|Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment).
1079319|NCT00616122|E1|Reported Event|Sunitinib, Cyclophosphamide, and Methotrexate|Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment).
1079320|NCT00616109|B1|Baseline|Sunitinib Maintenance Therapy|Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy.
1079321|NCT00616109|P1|Participant Flow|Sunitinib Maintenance Therapy|Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy.
1079322|NCT00616109|O1|Outcome|Sunitinib Maintenance Therapy|Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy.
1079323|NCT00616109|O1|Outcome|Sunitinib Maintenance Therapy|Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy.
1079324|NCT00616109|O1|Outcome|Sunitinib Maintenance Therapy|Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy.
1079393|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079325|NCT00616109|O1|Outcome|Sunitinib Maintenance Therapy|Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy. All patients who have received at least one cycle of sunitinib will be considered evaluable for response.
1079326|NCT00616109|E1|Reported Event|Sunitinib Maintenance Therapy|Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy.
1079327|NCT00616018|B1|Baseline|Acetaminophen|all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
1079328|NCT00616018|P1|Participant Flow|Acetaminophen|all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
1079329|NCT00616018|O1|Outcome|Acetaminophen|acetaminophen treatment group
1079330|NCT00616018|O1|Outcome|Acetaminophen|all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
1079331|NCT00616018|E1|Reported Event|Acetaminophen|all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
1079332|NCT00615992|B1|Baseline|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
1079333|NCT00615992|P1|Participant Flow|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
1079334|NCT00615992|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
1079335|NCT00615992|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
1079336|NCT00615992|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
1079337|NCT00615992|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
1079338|NCT00615992|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
1079339|NCT00615992|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
1079340|NCT00615992|E1|Reported Event|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
1079341|NCT00615927|B3|Baseline|Total|Total of all reporting groups
1079342|NCT00615927|B2|Baseline|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
1079343|NCT00615927|B1|Baseline|Astrocytoma|Grade II Astrocytoma
1079344|NCT00615927|P2|Participant Flow|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
1079345|NCT00615927|P1|Participant Flow|Astrocytoma|Grade II Astrocytoma
1079346|NCT00615927|O2|Outcome|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
1079347|NCT00615927|O1|Outcome|Astrocytoma|Grade II Astrocytoma
1079348|NCT00615927|O2|Outcome|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
1079349|NCT00615927|O1|Outcome|Astrocytoma|Grade II Astrocytoma
1079350|NCT00615927|O2|Outcome|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
1079351|NCT00615927|O1|Outcome|Astrocytoma|Grade II Astrocytoma
1079352|NCT00615927|O2|Outcome|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
1079353|NCT00615927|O1|Outcome|Astrocytoma|Grade II Astrocytoma
1079354|NCT00615927|O2|Outcome|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
1079355|NCT00615927|O1|Outcome|Astrocytoma|Grade II Astrocytoma
1079356|NCT00615927|E2|Reported Event|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
1079357|NCT00615927|E1|Reported Event|Astrocytoma|Grade II Astrocytoma
1079358|NCT00615914|B1|Baseline|Pramipexole|Pramipexole tablets were administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated until symptom control was achieved. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
1079359|NCT00615914|P1|Participant Flow|Pramipexole|Pramipexole tablets - oral administration (0.125 mg and 0.5 mg)
1079360|NCT00615914|O1|Outcome|Pramipexole|Pramipexole tablets were administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
1079361|NCT00615914|O1|Outcome|Pramipexole|The drug was administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
1079362|NCT00615914|O1|Outcome|Pramipexole|The drug was administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
1079363|NCT00615914|O1|Outcome|Pramipexole|The drug was administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
1079364|NCT00615914|E1|Reported Event|Pramipexole|Pramipexole tablets - oral administration (0.125 mg and 0.5 mg) was administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
1079365|NCT00615901|B1|Baseline|Cohort A (CMF at 14 Day Intervals)|"This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim.~cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim: C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle."
1079525|NCT00615264|B3|Baseline|Total|Total of all reporting groups
1084986|NCT00603525|O1|Outcome|Placebo|
1079366|NCT00615901|P1|Participant Flow|Cohort A (CMF at 14 Day Intervals)|"This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim.~cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim: C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle."
1079367|NCT00615901|O1|Outcome|Cohort A (CMF at 14 Day Intervals)|"This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim for a cohort of 38 patients. A safety analysis will then be performed.~cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim: C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle."
1079368|NCT00615901|E1|Reported Event|Cohort A (CMF at 14 Day Intervals)|"This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim.~cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim: C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle."
1079369|NCT00615836|B5|Baseline|Total|Total of all reporting groups
1079370|NCT00615836|B4|Baseline|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079371|NCT00615836|B3|Baseline|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079372|NCT00615836|B2|Baseline|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079373|NCT00615836|B1|Baseline|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
1079374|NCT00615836|P5|Participant Flow|Placebo|Participants took a placebo 'Melt' for 28 days to complete Part I of Study CS29. In Part II, placebo patients were randomized to 1 of the other 4 treatment arms to receive active desmopressin Melt, continuing into Study CS31.
1079375|NCT00615836|P4|Participant Flow|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29 and for up to 2 years and 2.5 months in Study CS31.
1079376|NCT00615836|P3|Participant Flow|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29 and for up to 2 years and 2.5 months in Study CS31.
1079377|NCT00615836|P2|Participant Flow|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29 and for up to 2 years and 2.5 months in Study CS31.
1079378|NCT00615836|P1|Participant Flow|Desmopressin Melt 10 μg|"Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29, continuing in Study CS31.~During CS31, based on the results of CS29, participants were randomly assigned to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg)."
1079379|NCT00615836|O5|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
1079380|NCT00615836|O4|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
1079381|NCT00615836|O3|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
1079382|NCT00615836|O2|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, in CS29 and CS31 until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
1079383|NCT00615836|O1|Outcome|Placebo|Participants took a placebo 'Melt' for 28 days to complete Part I of study CS29. In Part II, placebo patients were randomized to 1 of the other 4 treatment arms to receive active desmopressin Melt.
1079384|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079385|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079386|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079387|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
1079388|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079389|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079390|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079391|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
1079395|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
1079396|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079397|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079398|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079399|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
1079400|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079401|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079402|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079403|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
1079404|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079405|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079406|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079407|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
1079408|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079409|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079410|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079411|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
1079412|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079413|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079414|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079415|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
1079416|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079417|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079418|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079419|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
1079420|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079421|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079422|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079423|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
1079424|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079425|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079426|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079527|NCT00615264|B1|Baseline|DiaPep277|"DiaPep277 1.0 mg + 40 mg Mannitol in 0.5mL Lipid emulsion.~DiaPep277: 1.0 mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months"
1079427|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
1079428|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079429|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079430|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
1079431|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
1079432|NCT00615836|E5|Reported Event|Desmopressin Melt 100 μg|Participants received desmopressin melt 100 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
1079433|NCT00615836|E4|Reported Event|Desmopressin Melt 50 μg|Participants received desmopressin melt 50 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
1079434|NCT00615836|E3|Reported Event|Desmopressin Melt 25 μg|Participants received desmopressin melt 25 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
1079435|NCT00615836|E2|Reported Event|Desmopressin Melt 10 μg|Participants received desmopressin melt 10 μg once a day, in CS29 and CS31 until they were re-randomized to one of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
1079436|NCT00615836|E1|Reported Event|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of study CS29. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt.
1079437|NCT00615719|B1|Baseline|ED Patients Undergoing Coronary CTA|Usefulness of Computed Tomographic (CT) Coronary Angiography (CTCA) to Evaluate Emergency Department (ED) Patients With Chest Pain (EDCCTA). Patients were to undergo Coronary CT angiography in addition to the nuclear perfusion imaging performed as the standard of care.
1079438|NCT00615719|P1|Participant Flow|ED Patients Undergoing Coronary CTA|Usefulness of Computed Tomographic (CT) Coronary Angiography (CTCA) to Evaluate Emergency Department (ED) Patients With Chest Pain (EDCCTA). Patients were to undergo Coronary CT angiography in addition to the nuclear perfusion imaging performed as the standard of care.
1079439|NCT00615719|O1|Outcome|Computed Tomographic Coronary Angiography for Chest Pain Evalu|Usefulness of Computed Tomographic (CT) Coronary Angiography (CTCA) to Evaluate Emergency Department (ED) Patients With Chest Pain (EDCCTA)
1079440|NCT00615719|E1|Reported Event|ED Patients Undergoing Coronary CTA|Usefulness of Computed Tomographic (CT) Coronary Angiography (CTCA) to Evaluate Emergency Department (ED) Patients With Chest Pain (EDCCTA). Patients were to undergo Coronary CT angiography in addition to the nuclear perfusion imaging performed as the standard of care.
1079441|NCT00615589|B1|Baseline|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.~Fludarabine/Busulfan x 4 days:~Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.~Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days –5, –4, -3, and –2.~The Fludarabine shall be administered prior to the Busulfan each day."
1079442|NCT00615589|P1|Participant Flow|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen (Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.~Fludarabine/Busulfan x 4 days:~Fludarabine: 40 mg/m2/day, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.~Busulfan: 3.2 mg/kg IV daily over 4 hours on days –5, –4, -3, and –2.~The Fludarabine shall be administered prior to the Busulfan each day."
1079443|NCT00615589|O1|Outcome|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen (Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.~Fludarabine/Busulfan x 4 days:~Fludarabine: 40 mg/m2/day, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.~Busulfan: 3.2 mg/kg IV daily over 4 hours on days –5, –4, -3, and –2.~The Fludarabine shall be administered prior to the Busulfan each day."
1079444|NCT00615589|O1|Outcome|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.~Fludarabine/Busulfan x 4 days:~Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.~Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days –5, –4, -3, and –2.~The Fludarabine shall be administered prior to the Busulfan each day."
1079445|NCT00615589|O1|Outcome|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.~Fludarabine/Busulfan x 4 days:~Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.~Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days –5, –4, -3, and –2.~The Fludarabine shall be administered prior to the Busulfan each day."
1079446|NCT00615589|O1|Outcome|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.~Fludarabine/Busulfan x 4 days:~Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.~Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days –5, –4, -3, and –2.~The Fludarabine shall be administered prior to the Busulfan each day."
1079447|NCT00615589|O1|Outcome|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.~Fludarabine/Busulfan x 4 days:~Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.~Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days –5, –4, -3, and –2.~The Fludarabine shall be administered prior to the Busulfan each day."
1079526|NCT00615264|B2|Baseline|Placebo|"Mannitol 40 mg in 0.5 mL Lipid emulsion.~Placebo: Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months."
1080188|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
1079448|NCT00615589|E1|Reported Event|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.~Fludarabine/Busulfan x 4 days:~Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.~Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days –5, –4, -3, and –2.~The Fludarabine shall be administered prior to the Busulfan each day."
1079449|NCT00615550|B3|Baseline|Total|Total of all reporting groups
1079450|NCT00615550|B2|Baseline|Prochieve|Progesterone 8% Vaginal Gel
1079451|NCT00615550|B1|Baseline|Placebo|placebo vaginal gel
1079452|NCT00615550|P2|Participant Flow|Prochieve|Progesterone 8% Vaginal Gel
1079453|NCT00615550|P1|Participant Flow|Placebo|placebo vaginal gel
1079454|NCT00615550|O2|Outcome|Prochieve|Progesterone 8% Vaginal Gel
1079455|NCT00615550|O1|Outcome|Placebo|placebo vaginal gel
1079456|NCT00615550|O2|Outcome|Prochieve|Progesterone 8% Vaginal Gel
1079457|NCT00615550|O1|Outcome|Placebo|placebo vaginal gel
1079458|NCT00615550|O2|Outcome|Prochieve|Progesterone 8% Vaginal Gel
1079459|NCT00615550|O1|Outcome|Placebo|placebo vaginal gel
1079460|NCT00615550|O2|Outcome|Prochieve|Progesterone 8% Vaginal Gel
1079461|NCT00615550|O1|Outcome|Placebo|placebo vaginal gel
1079462|NCT00615550|O2|Outcome|Prochieve|Progesterone 8% Vaginal Gel
1079463|NCT00615550|O1|Outcome|Placebo|placebo vaginal gel
1079464|NCT00615550|E2|Reported Event|Prochieve|Progesterone 8% Vaginal Gel
1079465|NCT00615550|E1|Reported Event|Placebo|placebo vaginal gel
1079466|NCT00615472|B3|Baseline|Total|Total of all reporting groups
1079467|NCT00615472|B2|Baseline|Intravenous Anesthesia|"Intravenous Anesthesia - propofol, remifentanil~Remifentanil: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min.~Propofol: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed"
1079468|NCT00615472|B1|Baseline|Inhaled Anesthesia|"Inhaled Anesthesia - isoflurane~Isoflurane: Group 1 Inhaled anesthesia Patients will be maintained on 50% oxygen in air and isoflurane 0 to 4%, titrated as needed to maintain a standard blood pressure (standard practice). If needed, muscle relaxation will be provided by additional boluses or an infusion of mivacurium (4-10 ug/kg/min)."
1079469|NCT00615472|P2|Participant Flow|Intravenous Anesthesia|Intravenous Anesthesia - propofol, remifentanil
1079470|NCT00615472|P1|Participant Flow|Inhaled Anesthesia|Inhaled Anesthesia - isoflurane
1079471|NCT00615472|O2|Outcome|Group 2|"Intravenous Anesthesia - propofol, remifentanil~Remifentanil: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min.~Propofol: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min."
1079472|NCT00615472|O1|Outcome|Group 1|"Inhaled Anesthesia - isoflurane~Isoflurane: Group 1 Inhaled anesthesia Patients will be maintained on 50% oxygen in air and isoflurane 0 to 4%, titrated as needed to maintain a standard blood pressure (standard practice). If needed, muscle relaxation will be provided by additional boluses or an infusion of mivacurium (4-10 ug/kg/min)."
1079473|NCT00615472|E2|Reported Event|Group 2|"Intravenous Anesthesia - propofol, remifentanil~Remifentanil: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min.~Propofol: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min."
1079474|NCT00615472|E1|Reported Event|Group 1|"Inhaled Anesthesia - isoflurane~Isoflurane: Group 1 Inhaled anesthesia Patients will be maintained on 50% oxygen in air and isoflurane 0 to 4%, titrated as needed to maintain a standard blood pressure (standard practice). If needed, muscle relaxation will be provided by additional boluses or an infusion of mivacurium (4-10 ug/kg/min)."
1079475|NCT00615459|B1|Baseline|Total Patients|The safety population, included all patients who received at least one dose of study drug.
1079476|NCT00615459|P4|Participant Flow|Sequence 4: Tiotropium, Placebo, Indacaterol 300 μg|In period I, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via SDDPI. In period II, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. In period III, indacaterol 300 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
1079477|NCT00615459|P3|Participant Flow|Sequence 3: Indacaterol 150 μg, Indacaterol 300 μg, Placebo|In period I, indacaterol 150 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period II, indacaterol 300 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period III, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
1079478|NCT00615459|P2|Participant Flow|Sequence 2: Indacaterol 300 μg, Indacaterol 150 μg, Tiotropium|In period I,indacaterol 300 μg once daily delivered via single dose dry powder inhaler (SDDPI)and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period II, indacaterol 150 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period III, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via SDDPI. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
1079479|NCT00615459|P1|Participant Flow|Sequence 1: Placebo,Tiotropium, Indacaterol 150 μg|In period I, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. In period II, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via single dose dry powder inhaler (SDDPI). In period III, indacaterol 150 μg once daily delivered via SDDPI and placebo to tiotropium was delivered once daily via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
1079480|NCT00615459|O4|Outcome|Placebo|Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
1079481|NCT00615459|O3|Outcome|Tiotropium 18 μg|Tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
1079482|NCT00615459|O2|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once daily delivered via single dose dry powder inhaler (SDDPI)and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
1079483|NCT00615459|O1|Outcome|Indacaterol 150 μg|Indacaterol 150 μg once daily delivered via SDDPI and placebo to tiotropium was delivered once daily via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
1079484|NCT00615459|O4|Outcome|Placebo|Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
1079485|NCT00615459|O3|Outcome|Tiotropium 18 μg|Tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
1079486|NCT00615459|O2|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once daily delivered via single dose dry powder inhaler (SDDPI)and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
1079487|NCT00615459|O1|Outcome|Indacaterol 150 μg|Indacaterol 150 μg once daily delivered via SDDPI and placebo to tiotropium was delivered once daily via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
1079488|NCT00615459|E4|Reported Event|Placebo|Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
1079489|NCT00615459|E3|Reported Event|Tiotropium 18 μg|Tiotropium 18 μg once daily delivered via inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
1079490|NCT00615459|E2|Reported Event|Indacaterol 300 μg|Indacaterol 300 μg once daily delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
1079491|NCT00615459|E1|Reported Event|Indacaterol 150 μg|Indacaterol 150 μg once daily delivered via single dose dry powder inhaler (SDDPI) and placebo to tiotropium was delivered once daily via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
1079492|NCT00615433|B5|Baseline|Total|Total of all reporting groups
1079493|NCT00615433|B4|Baseline|Placebo|Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
1079494|NCT00615433|B3|Baseline|15mg Olz|3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
1079495|NCT00615433|B2|Baseline|120mg|3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication.
1079496|NCT00615433|B1|Baseline|40mg|Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
1079497|NCT00615433|P4|Participant Flow|Placebo|Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
1079582|NCT00615108|O3|Outcome|Total|Telmisartan 40mg or 80 mg
1079583|NCT00615108|O2|Outcome|Micardis 80mg|Telmisartan 80 mg
1079498|NCT00615433|P3|Participant Flow|15mg Olz|3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
1079499|NCT00615433|P2|Participant Flow|120mg|3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication.
1079500|NCT00615433|P1|Participant Flow|40mg|Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
1079501|NCT00615433|O4|Outcome|Placebo|Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
1079502|NCT00615433|O3|Outcome|15mg Olz|3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
1079503|NCT00615433|O2|Outcome|120mg|3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication.
1079504|NCT00615433|O1|Outcome|40mg|Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
1079505|NCT00615433|O4|Outcome|Placebo|Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
1079506|NCT00615433|O3|Outcome|15mg Olz|3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
1079507|NCT00615433|O2|Outcome|120mg|3 40 mg tablets taken orally once a day.
1079508|NCT00615433|O1|Outcome|40mg|Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
1079509|NCT00615433|E4|Reported Event|Placebo|Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
1079510|NCT00615433|E3|Reported Event|15mg Olz|3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
1079511|NCT00615433|E2|Reported Event|120mg|3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication.
1079512|NCT00615433|E1|Reported Event|40mg|Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
1079513|NCT00615290|B1|Baseline|Aptivus|Patients treated by Aptivus in daily practice
1079514|NCT00615290|P1|Participant Flow|Aptivus|Patients treated by Aptivus in daily practice
1079515|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
1079516|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
1079517|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
1079518|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
1079519|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
1079520|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
1079521|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
1079522|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
1079523|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
1079524|NCT00615290|E1|Reported Event|Aptivus|Patients treated by Aptivus in daily practice
1079528|NCT00615264|P2|Participant Flow|Placebo|"Mannitol 40 mg in 0.5 mL lipid emulsion.~Placebo: Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months."
1079529|NCT00615264|P1|Participant Flow|DiaPep277|"DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion.~DiaPep277: 1.0 mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months"
1079530|NCT00615264|O2|Outcome|Placebo|"Mannitol 40 mg in 0.5 mL lipid emulsion.~Placebo: Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months."
1079531|NCT00615264|O1|Outcome|DiaPep277|"DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion.~DiaPep277: 1.0 mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months"
1079532|NCT00615264|O2|Outcome|Placebo|"Mannitol 40 mg in 0.5 mL lipid emulsion.~Placebo: Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months."
1079533|NCT00615264|O1|Outcome|DiaPep277|"DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion.~DiaPep277: 1.0 mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months"
1079534|NCT00615264|E2|Reported Event|Placebo|"Mannitol 40 mg in 0.5 mL lipid emulsion.~Placebo: Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months."
1079535|NCT00615264|E1|Reported Event|DiaPep277|"DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion.~DiaPep277: 1.0 mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months"
1079536|NCT00615199|B5|Baseline|Total|Total of all reporting groups
1079537|NCT00615199|B4|Baseline|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
1079538|NCT00615199|B3|Baseline|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
1079539|NCT00615199|B2|Baseline|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
1079540|NCT00615199|B1|Baseline|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
1079541|NCT00615199|P4|Participant Flow|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
1079542|NCT00615199|P3|Participant Flow|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
1079543|NCT00615199|P2|Participant Flow|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
1079544|NCT00615199|P1|Participant Flow|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
1079545|NCT00615199|O4|Outcome|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
1079546|NCT00615199|O3|Outcome|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
1079547|NCT00615199|O2|Outcome|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
1079548|NCT00615199|O1|Outcome|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
1079549|NCT00615199|O4|Outcome|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
1079550|NCT00615199|O3|Outcome|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
1079551|NCT00615199|O2|Outcome|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
1079552|NCT00615199|O1|Outcome|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
1079553|NCT00615199|O4|Outcome|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
1079554|NCT00615199|O3|Outcome|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
1079555|NCT00615199|O2|Outcome|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
1079556|NCT00615199|O1|Outcome|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
1079557|NCT00615199|O4|Outcome|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
1079558|NCT00615199|O3|Outcome|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
1079559|NCT00615199|O2|Outcome|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
1079560|NCT00615199|O1|Outcome|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
1079561|NCT00615199|O4|Outcome|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
1079562|NCT00615199|O3|Outcome|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
1079563|NCT00615199|O2|Outcome|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
1079564|NCT00615199|O1|Outcome|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
1079565|NCT00615199|O4|Outcome|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
1079566|NCT00615199|O3|Outcome|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
1079567|NCT00615199|O2|Outcome|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
1079568|NCT00615199|O1|Outcome|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
1079569|NCT00615199|O4|Outcome|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
1079570|NCT00615199|O3|Outcome|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
1079571|NCT00615199|O2|Outcome|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
1079572|NCT00615199|O1|Outcome|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
1079573|NCT00615199|E4|Reported Event|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
1079574|NCT00615199|E3|Reported Event|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
1079575|NCT00615199|E2|Reported Event|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
1079576|NCT00615199|E1|Reported Event|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
1079577|NCT00615108|B1|Baseline|Hypertension Patients|Telmisartan 40mg or 80 mg
1079578|NCT00615108|P1|Participant Flow|Hypertension Patients|Telmisartan 40mg or 80 mg
1079579|NCT00615108|O3|Outcome|Total|Telmisartan 40mg or 80 mg
1079580|NCT00615108|O2|Outcome|Micardis 80mg|Telmisartan 80 mg
1079581|NCT00615108|O1|Outcome|Micardis 40mg|Telmisartan 40 mg
1079673|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
1080199|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
1079592|NCT00615069|B1|Baseline|31 mm GORE EXCLUDER® Test Subjects|GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA). This study was designed for primary analysis following one year of follow up, however, total subject follow up is 5 years post treatment.
1079593|NCT00615069|P1|Participant Flow|31 mm GORE EXCLUDER® Test Subjects|GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA). This study was designed for primary analysis following one year of follow up, however, total subject follow up is 5 years post treatment. Participant Flow results reflect the final (5 year) data.
1079594|NCT00615069|O1|Outcome|31 mm GORE EXCLUDER® Test Subjects|GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA). This study was designed for primary analysis following one year of follow up.
1079595|NCT00615069|O1|Outcome|31 mm GORE EXCLUDER® Test Subjects|GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA). This study was designed for primary analysis following one year of follow up.
1079596|NCT00615069|E1|Reported Event|31 mm GORE EXCLUDER® Test Subjects|GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA).
1079597|NCT00615056|B5|Baseline|Total|Total of all reporting groups
1079598|NCT00615056|B4|Baseline|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079599|NCT00615056|B3|Baseline|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079600|NCT00615056|B2|Baseline|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079601|NCT00615056|B1|Baseline|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079602|NCT00615056|P4|Participant Flow|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079603|NCT00615056|P3|Participant Flow|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079604|NCT00615056|P2|Participant Flow|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079605|NCT00615056|P1|Participant Flow|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079606|NCT00615056|O4|Outcome|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079607|NCT00615056|O3|Outcome|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079608|NCT00615056|O2|Outcome|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079609|NCT00615056|O1|Outcome|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1080189|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
1079610|NCT00615056|O4|Outcome|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079611|NCT00615056|O3|Outcome|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079612|NCT00615056|O2|Outcome|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079613|NCT00615056|O1|Outcome|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079614|NCT00615056|O4|Outcome|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079615|NCT00615056|O3|Outcome|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079616|NCT00615056|O2|Outcome|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079617|NCT00615056|O1|Outcome|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079618|NCT00615056|O4|Outcome|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079619|NCT00615056|O3|Outcome|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079620|NCT00615056|O2|Outcome|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079621|NCT00615056|O1|Outcome|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079622|NCT00615056|O4|Outcome|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079623|NCT00615056|O3|Outcome|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079624|NCT00615056|O2|Outcome|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079667|NCT00615017|P5|Participant Flow|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
1079668|NCT00615017|P4|Participant Flow|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
1080190|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
1079625|NCT00615056|O1|Outcome|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079626|NCT00615056|O4|Outcome|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079627|NCT00615056|O3|Outcome|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079628|NCT00615056|O2|Outcome|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079629|NCT00615056|O1|Outcome|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079630|NCT00615056|E4|Reported Event|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079631|NCT00615056|E3|Reported Event|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079632|NCT00615056|E2|Reported Event|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079633|NCT00615056|E1|Reported Event|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
1079634|NCT00615030|B1|Baseline|Total Patients|
1079635|NCT00615030|P12|Participant Flow|Sequence 12: Placebo, Indacaterol Evening, Indacaterol Morning|In period, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period II, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period III, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
1079636|NCT00615030|P11|Participant Flow|Sequence 11:Salmeterol,Indacaterol Morning,Indacaterol Evening|In period I, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period II, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period III, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
1079637|NCT00615030|P10|Participant Flow|Sequence 10: Indacaterol Evening, Placebo, Salmeterol|In period I, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period II, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period III, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
1079669|NCT00615017|P3|Participant Flow|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
1079638|NCT00615030|P9|Participant Flow|Sequence 9:Indacaterol Morning, Salmeterol, Placebo|In period I, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period II, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period III, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
1079639|NCT00615030|P8|Participant Flow|Sequence 8: Placebo, Indacaterol Morning, Salmeterol|In period I, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period II, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via dry powder inhaler DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period III, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
1079640|NCT00615030|P7|Participant Flow|Sequence 7: Salmeterol, Indacaterol Evening, Placebo|In period I, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period II, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period III, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
1079641|NCT00615030|P6|Participant Flow|Sequence 6:Indacaterol Evening,Salmeterol, Indacaterol Morning|In period I, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period II, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period III, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
1079642|NCT00615030|P5|Participant Flow|Sequence 5: Indacaterol Morning, Placebo, Indacaterol Evening|In period I, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period II, During morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period III, Patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
1079643|NCT00615030|P4|Participant Flow|Sequence 4: Placebo, Salmeterol, Indacaterol Evening|In period I, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period II, salmeterol 50 μg twice daily delivered via dry powder inhaler (DPI). One of the two daily doses of salmeterol was administered in the morning and the second dose was in the evening along with placebo matching indacaterol delivered by SDDPI. In period III, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via dry DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
1079644|NCT00615030|P3|Participant Flow|Sequence 3: Salmeterol, Placebo, Indacaterol Morning|In period I, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose was in the evening along with placebo matching indacaterol delivered by SDDPI. In period II, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period III, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
1079645|NCT00615030|P2|Participant Flow|Sequence 2:Indacaterol Evening,Indacaterol Morning, Placebo|In period I, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period II, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period III, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
1079670|NCT00615017|P2|Participant Flow|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
1079646|NCT00615030|P1|Participant Flow|Sequence 1:Indacaterol Morning,Indacaterol Evening, Salmeterol|In period I, indacaterol 300 μg once a day in the morning delivered via single dose dry powder inhaler (SDDPI) with a placebo to salmeterol delivered via dry powder inhaler (DPI). Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period II, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period III, Salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and second dose in the evening along with placebo matching indacaterol delivered by SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
1079647|NCT00615030|O6|Outcome|Placebo Evening|Placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via manufacturer’s proprietary DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
1079648|NCT00615030|O5|Outcome|Placebo Morning|Placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via manufacturer’s proprietary DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
1079649|NCT00615030|O4|Outcome|Salmeterol Evening|In the evening, Salmeterol 50 μg delivered via dry powder inhaler (DPI) along with placebo matching indacaterol via SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
1079650|NCT00615030|O3|Outcome|Salmeterol Morning|In the morning, Salmeterol 50 μg delivered via dry powder inhaler (DPI) along with placebo matching indacaterol via SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
1079651|NCT00615030|O2|Outcome|Indacaterol Evening|Patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via single dose dry powder inhaler (SDDPI) with placebo to salmeterol delivered via dry powder inhaler (DPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
1079652|NCT00615030|O1|Outcome|Indacaterol Morning|Indacaterol 300 μg once a day in the morning delivered via single dose dry powder inhaler (SDDPI) with a placebo to salmeterol delivered via dry powder inhaler (DPI). Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
1079653|NCT00615030|O2|Outcome|Placebo|During evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
1079654|NCT00615030|O1|Outcome|Indacaterol Evening|Patients were instructed to take morning doses of a placebo to indacaterol delivered via single dose dry powder inhaler (SDDPI) and placebo to salmeterol delivered via dry powder inhaler (DPI). Indacaterol 300 μg once a day in the evening delivered via single dose dry powder inhaler (SDDPI) with placebo to salmeterol delivered via dry powder inhaler (DPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
1079655|NCT00615030|E4|Reported Event|Placebo|During morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. All patients were provided with a SABA for use (if needed) as rescue medication throughout the study.
1079656|NCT00615030|E3|Reported Event|Salmeterol|Salmeterol 50 μg twice daily delivered via dry powder inhaler (DPI). One of the two daily doses of salmeterol was administered in the morning along with placebo matching indacaterol delivered by single dose dry powder inhaler (SDDPI). The second dose of salmeterol was administered in the evening along with placebo matching indacaterol delivered by SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. All patients were provided with a SABA for use (if needed) as rescue medication throughout the study.
1079657|NCT00615030|E2|Reported Event|Indacaterol Morning|Indacaterol 300 μg once a day in the morning delivered via single dose dry powder inhaler (SDDPI) with a placebo to salmeterol delivered via dry powder inhaler (DPI). Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. All patients were provided with a SABA for use (if needed) as rescue medication throughout the study.
1079658|NCT00615030|E1|Reported Event|Indacaterol Evening|Patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via single dose dry powder inhaler (SDDPI) with placebo to salmeterol delivered via dry powder inhaler (DPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. All patients were provided with a SABA for use (if needed) as rescue medication throughout the study.
1079659|NCT00615017|B7|Baseline|Total|Total of all reporting groups
1079660|NCT00615017|B6|Baseline|Placebo|Placebo
1079661|NCT00615017|B5|Baseline|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
1079662|NCT00615017|B4|Baseline|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
1079663|NCT00615017|B3|Baseline|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
1079664|NCT00615017|B2|Baseline|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
1080191|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
1079674|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
1079675|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
1079676|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
1079677|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
1079678|NCT00615017|O6|Outcome|Placebo|Placebo
1079679|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
1079680|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
1079681|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
1079682|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
1079683|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
1079684|NCT00615017|O6|Outcome|Placebo|Placebo
1079685|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
1079686|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
1079687|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
1079688|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
1079689|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
1079690|NCT00615017|O6|Outcome|Placebo|Placebo
1079691|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
1079692|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
1079693|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
1079694|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
1079695|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
1079696|NCT00615017|O6|Outcome|Placebo|Placebo
1079697|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
1079698|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
1079699|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
1079700|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
1079701|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
1079702|NCT00615017|O6|Outcome|Placebo|Placebo
1079703|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
1079704|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
1079705|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
1079706|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
1079707|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
1079708|NCT00615017|O6|Outcome|Placebo|Placebo
1079709|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
1079710|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
1079711|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
1079712|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
1079713|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
1079714|NCT00615017|O6|Outcome|Placebo|Placebo
1079715|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
1079716|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
1079717|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
1079718|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
1079719|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
1079720|NCT00615017|O6|Outcome|Placebo|Placebo
1079721|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
1079722|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
1079723|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
1079724|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
1079725|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
1079726|NCT00615017|O6|Outcome|Placebo|Placebo
1084987|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
1079727|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
1079728|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
1079729|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
1079730|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
1079731|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
1079732|NCT00615017|O6|Outcome|Placebo|Placebo
1079733|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
1079734|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
1079735|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
1079736|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
1079737|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
1079738|NCT00615017|O6|Outcome|Placebo|Placebo
1079739|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
1079740|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
1079741|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
1079742|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
1079743|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
1079744|NCT00615017|O6|Outcome|Placebo|Placebo
1079745|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
1079746|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
1079747|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
1079748|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
1079749|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
1079750|NCT00615017|O6|Outcome|Placebo|Placebo
1079751|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
1079752|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
1079753|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
1079754|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
1079755|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
1079756|NCT00615017|O6|Outcome|Placebo|Placebo
1079757|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
1079758|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
1079759|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
1079760|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
1079761|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
1079762|NCT00615017|O6|Outcome|Placebo|Placebo
1079763|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
1079764|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
1079765|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
1079766|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
1079767|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
1079768|NCT00615017|O6|Outcome|Placebo|Placebo
1079769|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
1079770|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
1079771|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
1079772|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
1079773|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
1079774|NCT00615017|O6|Outcome|Placebo|Placebo
1079775|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
1079776|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
1079777|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
1079778|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
1079779|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
1079780|NCT00615017|O6|Outcome|Placebo|Placebo
1084988|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
1079781|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
1079782|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
1079783|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
1079784|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
1079785|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
1079786|NCT00615017|O6|Outcome|Placebo|Placebo
1079787|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
1079788|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
1079789|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
1079790|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
1079791|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
1079792|NCT00615017|O6|Outcome|Placebo|Placebo
1079793|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
1079794|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
1079795|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
1079796|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
1079797|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
1079798|NCT00615017|O6|Outcome|Placebo|Placebo
1079799|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
1079800|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
1079801|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
1079802|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
1079803|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
1079804|NCT00615017|O6|Outcome|Placebo|Placebo
1079805|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
1079806|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
1079807|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
1079808|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
1079809|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
1079810|NCT00615017|O6|Outcome|Placebo|Placebo
1079811|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
1079812|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
1079813|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
1079814|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
1079815|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
1079816|NCT00615017|E6|Reported Event|Placebo|Placebo
1079817|NCT00615017|E5|Reported Event|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
1079818|NCT00615017|E4|Reported Event|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
1079819|NCT00615017|E3|Reported Event|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
1079820|NCT00615017|E2|Reported Event|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
1079821|NCT00615017|E1|Reported Event|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
1079822|NCT00614991|B7|Baseline|Total|Total of all reporting groups
1079823|NCT00614991|B6|Baseline|Group F|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
1079824|NCT00614991|B5|Baseline|Group E|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
1079825|NCT00614991|B4|Baseline|Group D|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
1079826|NCT00614991|B3|Baseline|Group C|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
1079827|NCT00614991|B2|Baseline|Group B|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
1079828|NCT00614991|B1|Baseline|Group A|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
1079829|NCT00614991|P6|Participant Flow|Group F|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
1079830|NCT00614991|P5|Participant Flow|Group E|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg once daily (QD) + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
1080193|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
1080194|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
1079831|NCT00614991|P4|Participant Flow|Group D|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
1079832|NCT00614991|P3|Participant Flow|Group C|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
1079833|NCT00614991|P2|Participant Flow|Group B|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
1079834|NCT00614991|P1|Participant Flow|Group A|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
1079835|NCT00614991|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
1079836|NCT00614991|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
1079837|NCT00614991|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID"
1079838|NCT00614991|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
1079839|NCT00614991|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
1079840|NCT00614991|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID"
1079841|NCT00614991|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
1079842|NCT00614991|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Raltegravir 100mg BID"
1079843|NCT00614991|O1|Outcome|Group A & B|Group A Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Group B Period 1-Raltegravir 400mg BID Period2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
1079844|NCT00614991|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
1079845|NCT00614991|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
1079846|NCT00614991|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID"
1079847|NCT00614991|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
1079848|NCT00614991|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
1079849|NCT00614991|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID"
1079850|NCT00614991|O6|Outcome|Group F|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
1079851|NCT00614991|O5|Outcome|Group E|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
1079852|NCT00614991|O4|Outcome|Group D|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Raltegravir 100mg BID
1079853|NCT00614991|O3|Outcome|Group C|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
1079854|NCT00614991|O2|Outcome|Group B|Period 1-Raltegravir 400mg BID Period2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
1079855|NCT00614991|O1|Outcome|Group A|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
1084989|NCT00603525|O1|Outcome|Placebo|
1079856|NCT00614991|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
1079857|NCT00614991|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
1079858|NCT00614991|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID"
1079859|NCT00614991|E6|Reported Event|Group F|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
1079860|NCT00614991|E5|Reported Event|Group E|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
1079861|NCT00614991|E4|Reported Event|Group D|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Raltegravir 100mg BID
1079862|NCT00614991|E3|Reported Event|Group C|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
1079863|NCT00614991|E2|Reported Event|Group B|Period 1-Raltegravir 400mg BID Period2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
1079864|NCT00614991|E1|Reported Event|Group A|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
1079865|NCT00614939|B3|Baseline|Total|Total of all reporting groups
1079866|NCT00614939|B2|Baseline|Saxa|Saxagliptin 2.5 mg once daily oral dose
1079867|NCT00614939|B1|Baseline|Placebo|Placebo
1079868|NCT00614939|P2|Participant Flow|Saxa|Saxagliptin 2.5 mg once daily oral dose
1079869|NCT00614939|P1|Participant Flow|Placebo|Placebo
1079870|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
1079871|NCT00614939|O1|Outcome|Placebo|Placebo
1079872|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
1079873|NCT00614939|O1|Outcome|Placebo|Placebo
1079874|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
1079875|NCT00614939|O1|Outcome|Placebo|Placebo
1079876|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
1079877|NCT00614939|O1|Outcome|Placebo|Placebo
1079878|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
1079879|NCT00614939|O1|Outcome|Placebo|Placebo
1079880|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
1079881|NCT00614939|O1|Outcome|Placebo|Placebo
1079882|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
1079883|NCT00614939|O1|Outcome|Placebo|Placebo
1079884|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
1079885|NCT00614939|O1|Outcome|Placebo|Placebo
1079886|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
1079887|NCT00614939|O1|Outcome|Placebo|Placebo
1079888|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
1079889|NCT00614939|O1|Outcome|Placebo|Placebo
1079890|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
1079891|NCT00614939|O1|Outcome|Placebo|Placebo
1079892|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
1079893|NCT00614939|O1|Outcome|Placebo|Placebo
1079894|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
1079895|NCT00614939|O1|Outcome|Placebo|Placebo
1079896|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
1079897|NCT00614939|O1|Outcome|Placebo|Placebo
1079898|NCT00614939|E2|Reported Event|Saxa|Saxagliptin 2.5 mg once daily oral dose
1079899|NCT00614939|E1|Reported Event|Placebo|Placebo
1079900|NCT00614926|B3|Baseline|Total|Total of all reporting groups
1079901|NCT00614926|B2|Baseline|Placebo|Placebo capsules are administered on the same schedule as active drug: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day in the absence of clinical improvement and dose limiting side effects. Dose is daily, in A.M.
1079902|NCT00614926|B1|Baseline|Modafinil|Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks.
1079903|NCT00614926|P2|Participant Flow|Placebo|Placebo capsules are administered on the same schedule as active drug: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day in the absence of clinical improvement and dose limiting side effects. Dose is daily, in A.M.
1079904|NCT00614926|P1|Participant Flow|Modafinil|Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks.
1079905|NCT00614926|O2|Outcome|Placebo|Placebo capsules are administered on the same schedule as active drug: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day in the absence of clinical improvement and dose limiting side effects. Dose is daily, in A.M.
1079906|NCT00614926|O1|Outcome|Modafinil|Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks.
1079907|NCT00614926|O2|Outcome|Placebo|Placebo capsules are administered on the same schedule as active drug: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day in the absence of clinical improvement and dose limiting side effects. Dose is daily, in A.M.
1084990|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
1079908|NCT00614926|O1|Outcome|Modafinil|Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks.
1079909|NCT00614926|E2|Reported Event|Placebo|Placebo capsules are administered on the same schedule as active drug: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day in the absence of clinical improvement and dose limiting side effects. Dose is daily, in A.M.
1079910|NCT00614926|E1|Reported Event|Modafinil|Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks.
1079911|NCT00614913|B1|Baseline|Proton Beam Therapy|Patients received 63Gy in three weeks with proton beam.
1079912|NCT00614913|P1|Participant Flow|Proton Beam Therapy|Patients received 63Gy in three weeks with proton beam.
1079913|NCT00614913|O1|Outcome|Proton Beam Therapy|Patients received 63Gy in three weeks with proton beam.
1079914|NCT00614913|O1|Outcome|Proton Beam Therapy|Patients received 63Gy in three weeks with proton beam.
1079915|NCT00614913|E1|Reported Event|Proton Beam Therapy|Patients received 63Gy in three weeks with proton beam.
1079916|NCT00614874|B1|Baseline|Rosiglitazone|Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
1079917|NCT00614874|P1|Participant Flow|Rosiglitazone|Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
1079918|NCT00614874|O1|Outcome|Rosiglitazone|Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
1079919|NCT00614874|O1|Outcome|Rosiglitazone|Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
1079920|NCT00614874|O1|Outcome|Rosiglitazone|Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
1079921|NCT00614874|O1|Outcome|Rosiglitazone|Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
1079922|NCT00614874|E1|Reported Event|Rosiglitazone|Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
1079923|NCT00614614|B3|Baseline|Total|Total of all reporting groups
1079924|NCT00614614|B2|Baseline|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
1079925|NCT00614614|B1|Baseline|Menhibrix 1 Group|Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during Primary Vaccination Phase.
1079926|NCT00614614|P5|Participant Flow|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079927|NCT00614614|P4|Participant Flow|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079928|NCT00614614|P3|Participant Flow|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079929|NCT00614614|P2|Participant Flow|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
1079930|NCT00614614|P1|Participant Flow|Menhibrix 1 Group|Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during the Primary Vaccination Phase. For the Booster Vaccination Phase, subjects were re-randomized and received either 1 dose of Nimenrix vaccine (at 12-15 months of age) and 1 dose of Infanrix vaccine (at 15-18 months of age) [Nimenrix 1 Group] or a fourth dose of Menhibrix vaccine (at 12-15 months of age) and 1 dose of Infanrix vaccine (at 15-18 months of age) [Menhibrix 2 Group], or 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine (at 15-18 months of age) [Nimenrix 2 Group].
1079931|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079932|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079933|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079934|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
1079935|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079936|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079937|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079938|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
1079939|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079940|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079941|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080192|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
1084991|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
1079942|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
1079943|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079944|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079945|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079946|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
1079947|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079948|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079949|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079950|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
1079951|NCT00614614|O2|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
1079952|NCT00614614|O1|Outcome|Menhibrix 1 Group|Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during Primary Vaccination Phase.
1079953|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age.during Booster Vaccination Phase.
1079954|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age.during Booster Vaccination Phase.
1079955|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079956|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
1079957|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079958|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age.during Booster Vaccination Phase.
1079959|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079960|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
1079961|NCT00614614|O2|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
1079962|NCT00614614|O1|Outcome|Menhibrix 1 Group|Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during Primary Vaccination Phase.
1079963|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079964|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079965|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079966|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
1079967|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079968|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079969|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079970|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
1079971|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079972|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079973|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079974|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
1079975|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079976|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079977|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079978|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
1079979|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079980|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079981|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079982|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
1079983|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079984|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079985|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079986|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
1079987|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079988|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079989|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079990|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
1079991|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079992|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079993|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079994|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
1079995|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079996|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079997|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1079998|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
1079999|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080000|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080001|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080002|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
1080003|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080004|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080005|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080006|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
1080007|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080008|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080009|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080010|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
1080011|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080012|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080013|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080014|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
1080015|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080016|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080017|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080018|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
1080019|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080020|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080021|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080022|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
1080023|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080024|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080025|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080026|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
1080027|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080028|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080029|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080030|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
1080031|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080032|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080033|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080034|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
1080035|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080036|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080037|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080038|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
1080039|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080040|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080041|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080042|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
1080043|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080044|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080045|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080046|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
1080047|NCT00614614|E5|Reported Event|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080048|NCT00614614|E4|Reported Event|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080049|NCT00614614|E3|Reported Event|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
1080050|NCT00614614|E2|Reported Event|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
1080051|NCT00614614|E1|Reported Event|Menhibrix 1 Group|Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during Primary Vaccination Phase.
1080052|NCT00614575|B1|Baseline|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
1080053|NCT00614575|P1|Participant Flow|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
1080054|NCT00614575|O1|Outcome|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
1080055|NCT00614575|O1|Outcome|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
1080070|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
1080056|NCT00614575|O1|Outcome|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
1080057|NCT00614575|O1|Outcome|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
1080058|NCT00614575|O1|Outcome|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
1080059|NCT00614575|O1|Outcome|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
1080060|NCT00614575|E1|Reported Event|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
1080061|NCT00614523|B3|Baseline|Total|Total of all reporting groups
1080062|NCT00614523|B2|Baseline|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
1080063|NCT00614523|B1|Baseline|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
1080064|NCT00614523|P2|Participant Flow|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
1080065|NCT00614523|P1|Participant Flow|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
1080066|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
1080067|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
1080068|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
1080069|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
1080182|NCT00614380|O1|Outcome|Pre-antihypertensive: Yes (DBP<90 mmHg)|
1080183|NCT00614380|O1|Outcome|Total|
1084992|NCT00603525|O1|Outcome|Placebo|
1080071|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
1080072|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
1080073|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
1080074|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
1080075|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
1080076|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
1080077|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
1080078|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
1080079|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
1080080|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
1080081|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
1080082|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
1080083|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
1080084|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
1080085|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
1080086|NCT00614523|E2|Reported Event|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
1080087|NCT00614523|E1|Reported Event|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
1080088|NCT00614484|B1|Baseline|Treatment With Chemotherapy and Proton Beam Radiotherapy.|Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
1080089|NCT00614484|P1|Participant Flow|Treatment With Chemotherapy and Proton Beam Radiotherapy.|Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
1080090|NCT00614484|O1|Outcome|Chemotherapy and Proton Therapy|Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
1080091|NCT00614484|O1|Outcome|Chemothrapy and Proton Therapy|Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
1080092|NCT00614484|E1|Reported Event|Treatment With Chemotherapy and Proton Beam Radiotherapy.|Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
1080093|NCT00614458|B1|Baseline|Effect on Latent HIV of Adding Raltegravir and/or VPA to ART|Single arm pilot study that measured the effect of adding Raltegravir and/or VPA and current ART on the persistence of latent HIV infection within circulating, resting CD4+ T cells in patients stably suppressed by ART
1084993|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
1080094|NCT00614458|P1|Participant Flow|Effect on Latent HIV of Adding Raltegravir and VPA to ART|Single arm pilot study that measured the effect of adding Raltegravir and Valproic acid (VPA) and current antiretroviral therapy (ART) on the persistence of latent HIV infection within circulating, resting CD4+ T cells in patients stably suppressed by ART
1080095|NCT00614458|O1|Outcome|Effect on Latent HIV of Adding Raltegravir and VPA to ART|
1080096|NCT00614458|E1|Reported Event|Effect on Latent HIV of Adding Raltegravir and/or VPA to ART|Single arm pilot study that measured the effect of adding Raltegravir and/or VPA and current ART on the persistence of latent HIV infection within circulating, resting CD4+ T cells in patients stably suppressed by ART
1080097|NCT00614445|B3|Baseline|Total|Total of all reporting groups
1080098|NCT00614445|B2|Baseline|Placebo|Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)
1080099|NCT00614445|B1|Baseline|Diclectin®|Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet
1080100|NCT00614445|P2|Participant Flow|Placebo|Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)
1080101|NCT00614445|P1|Participant Flow|Diclectin®|Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet
1080102|NCT00614445|O2|Outcome|Placebo|Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)
1080103|NCT00614445|O1|Outcome|Diclectin®|Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet
1080104|NCT00614445|E2|Reported Event|Placebo|Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)
1080105|NCT00614445|E1|Reported Event|Diclectin®|Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet
1080106|NCT00614406|B3|Baseline|Total|Total of all reporting groups
1080107|NCT00614406|B2|Baseline|Placebo|Group 2: control cycle, celecoxib cycle, placebo cycle orally, daily x1 menstrual cycle
1080108|NCT00614406|B1|Baseline|Active Drug Cycle|Group 1: control cycle, placebo cycle, active drug (celecoxib 400 mg orally, daily x1 menstrual cycle) cycle
1080109|NCT00614406|P2|Participant Flow|Placebo|Group 2: control cycle, celecoxib cycle, placebo cycle orally, daily x1 menstrual cycle
1080110|NCT00614406|P1|Participant Flow|Active Drug Cycle|Group 1: control cycle, placebo cycle, active drug (celecoxib 400 mg orally, daily x1 menstrual cycle) cycle
1080111|NCT00614406|O2|Outcome|Placebo|Placebo cycle orally, daily x1 menstrual cycle [cycle = length of menstrual cycle]
1080112|NCT00614406|O1|Outcome|Active Drug|Active drug(celecoxib 400 mg orally, daily for 1 menstrual cycle) cycle [cycle = length of menstrual cycle]
1080113|NCT00614406|E2|Reported Event|Placebo|Group 2: control cycle, celecoxib cycle, placebo cycle orally, daily x1 menstrual cycle
1080114|NCT00614406|E1|Reported Event|Active Drug Cycle|Group 1: control cycle, placebo cycle, active drug (celecoxib 400 mg orally, daily x1 menstrual cycle) cycle
1080115|NCT00614393|B6|Baseline|Total|Total of all reporting groups
1080116|NCT00614393|B5|Baseline|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
1080117|NCT00614393|B4|Baseline|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
1080118|NCT00614393|B3|Baseline|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
1080119|NCT00614393|B2|Baseline|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
1080120|NCT00614393|B1|Baseline|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
1080121|NCT00614393|P5|Participant Flow|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received a cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
1080122|NCT00614393|P4|Participant Flow|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
1080123|NCT00614393|P3|Participant Flow|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
1080124|NCT00614393|P2|Participant Flow|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the open-label (OL) portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV one time every two weeks (Q2W) for up to 32 months of treatment.
1080125|NCT00614393|P1|Participant Flow|Dalotuzumab 10 mg/kg Q1W (DB)|In double-blind (DB) Week 1, participants received cetuximab 400 mg/m^2 intravenously (IV) loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV one time each week (Q1W) maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
1080126|NCT00614393|O5|Outcome|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
1080127|NCT00614393|O4|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
1080128|NCT00614393|O3|Outcome|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
1080129|NCT00614393|O2|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
1080130|NCT00614393|O1|Outcome|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
1080131|NCT00614393|O5|Outcome|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
1080132|NCT00614393|O4|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
1080133|NCT00614393|O3|Outcome|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
1080134|NCT00614393|O2|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
1080135|NCT00614393|O1|Outcome|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
1080136|NCT00614393|O5|Outcome|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
1080137|NCT00614393|O4|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
1080138|NCT00614393|O3|Outcome|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
1080139|NCT00614393|O2|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
1080140|NCT00614393|O1|Outcome|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
1080141|NCT00614393|O5|Outcome|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
1080142|NCT00614393|O4|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
1080143|NCT00614393|O3|Outcome|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
1080144|NCT00614393|O2|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
1080145|NCT00614393|O1|Outcome|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
1080146|NCT00614393|O5|Outcome|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
1080147|NCT00614393|O4|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
1080148|NCT00614393|O3|Outcome|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
1080149|NCT00614393|O2|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
1080150|NCT00614393|O1|Outcome|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
1080151|NCT00614393|O5|Outcome|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
1080152|NCT00614393|O4|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
1080153|NCT00614393|O3|Outcome|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
1080184|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
1080154|NCT00614393|O2|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
1080155|NCT00614393|O1|Outcome|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
1080156|NCT00614393|O5|Outcome|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
1080157|NCT00614393|O4|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
1080158|NCT00614393|O3|Outcome|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
1080159|NCT00614393|O2|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
1080160|NCT00614393|O1|Outcome|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
1080161|NCT00614393|E5|Reported Event|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
1080162|NCT00614393|E4|Reported Event|Dalotuzumab 15 mg/kg /7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
1080163|NCT00614393|E3|Reported Event|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
1080164|NCT00614393|E2|Reported Event|Dalotuzumab 15 mg/kg /7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
1080165|NCT00614393|E1|Reported Event|Dalotuzumab 10 mg/kg Q1W (BD)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
1080166|NCT00614380|B5|Baseline|Total|Total of all reporting groups
1080167|NCT00614380|B4|Baseline|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
1080168|NCT00614380|B3|Baseline|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
1080169|NCT00614380|B2|Baseline|Telmisartan 80mg and Amlodipine 5mg|
1080170|NCT00614380|B1|Baseline|Telmisartan 40mg and Amlodipine 5mg|
1080171|NCT00614380|P4|Participant Flow|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
1080172|NCT00614380|P3|Participant Flow|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
1080173|NCT00614380|P2|Participant Flow|Telmisartan 80mg and Amlodipine 5mg|
1080174|NCT00614380|P1|Participant Flow|Telmisartan 40mg and Amlodipine 5mg|
1080175|NCT00614380|O3|Outcome|Pre-titration: Total|
1080176|NCT00614380|O2|Outcome|Pre-titration: No (DBP>=90 mmHg)|
1080177|NCT00614380|O1|Outcome|Pre-titration: Yes (DBP<90 mmHg)|
1080178|NCT00614380|O1|Outcome|Total|
1080179|NCT00614380|O1|Outcome|Total|
1080180|NCT00614380|O3|Outcome|Pre-antihypertensive: Total|
1080181|NCT00614380|O2|Outcome|Pre-antihypertensive: No (DBP>=90 mmHg)|
1080200|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
1080201|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
1080202|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
1080203|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
1080204|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
1080205|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
1080206|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
1080207|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
1080208|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
1080209|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
1080210|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
1080211|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
1080212|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
1080213|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
1080214|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
1080215|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
1080216|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
1080217|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
1080218|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
1080219|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
1080220|NCT00614380|E2|Reported Event|Telmisartan 80mg and Amlodipine 5mg|
1080221|NCT00614380|E1|Reported Event|Telmisartan 40mg and Amlodipine 5mg|
1080222|NCT00614315|B1|Baseline|FLAIR Endovascular Stent Graft|Patients treated with the FLAIR Endovascular Stent Graft
1080223|NCT00614315|P1|Participant Flow|FLAIR Endovascular Stent Graft|Patients treated with the FLAIR Endovascular Stent Graft
1080224|NCT00614315|O1|Outcome|FLAIR Endovascular Stent Graft|Patients treated with the FLAIR Endovascular Stent Graft
1080225|NCT00614315|O1|Outcome|FLAIR Endovascular Stent Graft|Patients treated with the FLAIR Endovascular Stent Graft
1080226|NCT00614315|E1|Reported Event|FLAIR Endovascular Stent Graft|Patients treated with the FLAIR Endovascular Stent Graft
1080227|NCT00614198|B3|Baseline|Total|Total of all reporting groups
1080228|NCT00614198|B2|Baseline|No Gluten- and Casein-free Dietary Intervention|Stage 1: No special dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If dietary intervention group showed group significant improvement progressed to stage 2 (introduction of a gluten- and casein-free diet for 12 months).
1080229|NCT00614198|B1|Baseline|Gluten- and Casein-free Dietary Intervention|Stage 1: Gluten- and casein-free dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If showed group significant improvement progressed to stage 2 (continued on a gluten- and casein-free diet for a further 12 months).
1080230|NCT00614198|P2|Participant Flow|No Gluten- and Casein-free Dietary Intervention|Stage 1: No special dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If dietary intervention group showed group significant improvement progressed to stage 2 (introduction of a gluten- and casein-free diet for 12 months).
1080231|NCT00614198|P1|Participant Flow|Gluten- and Casein-free Dietary Intervention|Stage 1: Gluten- and casein-free dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If showed group significant improvement progressed to stage 2 (continued on a gluten- and casein-free diet for a further 12 months).
1080232|NCT00614198|O2|Outcome|No Gluten- and Casein-free Dietary Intervention|Stage 1: No special dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If dietary intervention group showed group significant improvement progressed to stage 2 (introduction of a gluten- and casein-free diet for 12 months).
1080233|NCT00614198|O1|Outcome|Gluten- and Casein-free Dietary Intervention|Stage 1: Gluten- and casein-free dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If showed group significant improvement progressed to stage 2 (continued on a gluten- and casein-free diet for a further 12 months).
1080234|NCT00614198|E2|Reported Event|No Gluten- and Casein-free Dietary Intervention|Stage 1: No special dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If dietary intervention group showed group significant improvement progressed to stage 2 (introduction of a gluten- and casein-free diet for 12 months).
1080235|NCT00614198|E1|Reported Event|Gluten- and Casein-free Dietary Intervention|Stage 1: Gluten- and casein-free dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If showed group significant improvement progressed to stage 2 (continued on a gluten- and casein-free diet for a further 12 months).
1080236|NCT00614120|B5|Baseline|Total|Total of all reporting groups
1080237|NCT00614120|B4|Baseline|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
1080238|NCT00614120|B3|Baseline|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
1080239|NCT00614120|B2|Baseline|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
1080240|NCT00614120|B1|Baseline|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
1080241|NCT00614120|P4|Participant Flow|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
1084994|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
1080242|NCT00614120|P3|Participant Flow|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
1080243|NCT00614120|P2|Participant Flow|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
1080244|NCT00614120|P1|Participant Flow|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
1080245|NCT00614120|O4|Outcome|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
1080246|NCT00614120|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
1080247|NCT00614120|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
1080248|NCT00614120|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
1080249|NCT00614120|O4|Outcome|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
1080250|NCT00614120|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
1080251|NCT00614120|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
1080252|NCT00614120|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
1080253|NCT00614120|O4|Outcome|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
1080254|NCT00614120|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
1080255|NCT00614120|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
1080256|NCT00614120|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
1080257|NCT00614120|O4|Outcome|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
1080258|NCT00614120|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
1080259|NCT00614120|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
1080260|NCT00614120|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
1080261|NCT00614120|O4|Outcome|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
1080262|NCT00614120|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
1080263|NCT00614120|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
1080264|NCT00614120|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
1080265|NCT00614120|O4|Outcome|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
1080266|NCT00614120|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
1080267|NCT00614120|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
1080268|NCT00614120|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
1080269|NCT00614120|O4|Outcome|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
1080270|NCT00614120|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
1080271|NCT00614120|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
1080272|NCT00614120|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
1080273|NCT00614120|O4|Outcome|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
1080274|NCT00614120|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
1080275|NCT00614120|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
1080276|NCT00614120|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
1080277|NCT00614120|E4|Reported Event|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
1080278|NCT00614120|E3|Reported Event|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
1080279|NCT00614120|E2|Reported Event|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
1080280|NCT00614120|E1|Reported Event|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
1080281|NCT00614055|B4|Baseline|Total|Total of all reporting groups
1080282|NCT00614055|B3|Baseline|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080283|NCT00614055|B2|Baseline|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080284|NCT00614055|B1|Baseline|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080285|NCT00614055|P3|Participant Flow|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080286|NCT00614055|P2|Participant Flow|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080309|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080287|NCT00614055|P1|Participant Flow|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080373|NCT00613951|E3|Reported Event|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080288|NCT00614055|O3|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080289|NCT00614055|O2|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080290|NCT00614055|O1|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080291|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080292|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080293|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080294|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080295|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080296|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080297|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080298|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080299|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080300|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080301|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080302|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080303|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080304|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080305|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080306|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080307|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080308|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1084995|NCT00603525|O1|Outcome|Placebo|
1080310|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080311|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080312|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080313|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080314|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080315|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080316|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080317|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080318|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080319|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080320|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080321|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080322|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080323|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080324|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080325|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080326|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080327|NCT00614055|E3|Reported Event|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080328|NCT00614055|E2|Reported Event|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080329|NCT00614055|E1|Reported Event|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080330|NCT00613951|B4|Baseline|Total|Total of all reporting groups
1080331|NCT00613951|B3|Baseline|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080352|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1084996|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
1080479|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
1080332|NCT00613951|B2|Baseline|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080333|NCT00613951|B1|Baseline|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080334|NCT00613951|P3|Participant Flow|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080335|NCT00613951|P2|Participant Flow|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080336|NCT00613951|P1|Participant Flow|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080337|NCT00613951|O3|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080338|NCT00613951|O2|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080339|NCT00613951|O1|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080340|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080341|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080342|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080343|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080344|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080345|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080346|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080347|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080348|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080349|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080350|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080351|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080423|NCT00613925|E1|Reported Event|Pipelle Group|Women were randomized to the Pipelle for endometrial biopsy
1080353|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080354|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080355|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080356|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080357|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080358|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080359|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080360|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080361|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080362|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080363|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080364|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080365|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080366|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080367|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080368|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080369|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080370|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080371|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080372|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080541|NCT00613314|O1|Outcome|Telmisartan (Micardis)|
1080542|NCT00613314|O1|Outcome|Telmisartan (Micardis)|
1080374|NCT00613951|E2|Reported Event|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080375|NCT00613951|E1|Reported Event|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
1080376|NCT00613938|B5|Baseline|Total|Total of all reporting groups
1080377|NCT00613938|B4|Baseline|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
1080378|NCT00613938|B3|Baseline|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
1080379|NCT00613938|B2|Baseline|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
1080380|NCT00613938|B1|Baseline|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
1080381|NCT00613938|P4|Participant Flow|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
1080382|NCT00613938|P3|Participant Flow|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
1080383|NCT00613938|P2|Participant Flow|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
1080384|NCT00613938|P1|Participant Flow|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
1080385|NCT00613938|O4|Outcome|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
1080386|NCT00613938|O3|Outcome|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
1080387|NCT00613938|O2|Outcome|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
1080388|NCT00613938|O1|Outcome|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
1080389|NCT00613938|O4|Outcome|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
1080390|NCT00613938|O3|Outcome|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
1080391|NCT00613938|O2|Outcome|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
1080392|NCT00613938|O1|Outcome|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
1080393|NCT00613938|O4|Outcome|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
1080394|NCT00613938|O3|Outcome|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
1080395|NCT00613938|O2|Outcome|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
1080396|NCT00613938|O1|Outcome|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
1080397|NCT00613938|O4|Outcome|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
1080398|NCT00613938|O3|Outcome|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
1080399|NCT00613938|O2|Outcome|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
1080400|NCT00613938|O1|Outcome|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
1080401|NCT00613938|O4|Outcome|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
1080402|NCT00613938|O3|Outcome|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
1080403|NCT00613938|O2|Outcome|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
1080404|NCT00613938|O1|Outcome|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
1080405|NCT00613938|O4|Outcome|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
1080406|NCT00613938|O3|Outcome|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
1080407|NCT00613938|O2|Outcome|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
1080408|NCT00613938|O1|Outcome|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
1080409|NCT00613938|E4|Reported Event|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
1080410|NCT00613938|E3|Reported Event|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
1080411|NCT00613938|E2|Reported Event|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
1080412|NCT00613938|E1|Reported Event|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
1080413|NCT00613925|B3|Baseline|Total|Total of all reporting groups
1080414|NCT00613925|B2|Baseline|Explora Group|Women were randomized to the Explora device for endometrial biopsy
1080415|NCT00613925|B1|Baseline|Pipelle Group|Women were randomized to the Pipelle for endometrial biopsy
1080416|NCT00613925|P2|Participant Flow|Explora Group|Women were randomized to the Explora device for endometrial biopsy
1080417|NCT00613925|P1|Participant Flow|Pipelle Group|Women were randomized to the Pipelle for endometrial biopsy
1080418|NCT00613925|O2|Outcome|Explora Group|Women were randomized to the Explora device for endometrial biopsy
1080419|NCT00613925|O1|Outcome|Pipelle Group|Women were randomized to the Pipelle for endometrial biopsy
1080420|NCT00613925|O2|Outcome|Explora Group|Women were randomized to the Explora device for endometrial biopsy
1080421|NCT00613925|O1|Outcome|Pipelle Group|Women were randomized to the Pipelle for endometrial biopsy
1080422|NCT00613925|E2|Reported Event|Explora Group|Women were randomized to the Explora device for endometrial biopsy
1080480|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
1080424|NCT00613730|B1|Baseline|Gemcitabine + Panitumumab|Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
1080425|NCT00613730|P1|Participant Flow|Gemcitabine + Panitumumab|Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
1080426|NCT00613730|O1|Outcome|Gemcitabine + Panitumumab|Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
1080427|NCT00613730|O1|Outcome|Gemcitabine + Panitumumab|Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
1080428|NCT00613730|O1|Outcome|Gemcitabine + Panitumumab|Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
1080429|NCT00613730|E1|Reported Event|Gemcitabine + Panitumumab|Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
1080430|NCT00613626|B4|Baseline|Total|Total of all reporting groups
1080431|NCT00613626|B3|Baseline|Safety Lead-In|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator. The safety lead-in will be conducted to determine the safety of the combination of ZD6474 and cisplation + etopiside. If this combination is found to be unsafe, no patients will be randomized in the Phase II portion of the trial. If the combination is deemed safe according to the protocol, participants from the safety lead-in cohort will not be included in the efficacy analysis.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
1080432|NCT00613626|B2|Baseline|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
1080433|NCT00613626|B1|Baseline|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~Placebo: Matched placebo oral daily"
1080434|NCT00613626|P3|Participant Flow|Safety Lead-In|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator. The safety lead-in will be conducted to determine the safety of the combination of ZD6474 and cisplation + etopiside. If this combination is found to be unsafe, no patients will be randomized in the Phase II portion of the trial. If the combination is deemed safe according to the protocol, participants from the safety lead-in cohort will not be included in the efficacy analysis.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
1080435|NCT00613626|P2|Participant Flow|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
1080543|NCT00613314|O1|Outcome|Telmisartan (Micardis)|
1080544|NCT00613314|O1|Outcome|Telmisartan (Micardis)|
1080436|NCT00613626|P1|Participant Flow|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~Placebo: Matched placebo oral daily"
1080437|NCT00613626|O2|Outcome|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
1080438|NCT00613626|O1|Outcome|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~Placebo: Matched placebo oral daily"
1080439|NCT00613626|O2|Outcome|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
1080440|NCT00613626|O1|Outcome|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~Placebo: Matched placebo oral daily"
1080441|NCT00613626|O2|Outcome|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
1080442|NCT00613626|O1|Outcome|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~Placebo: Matched placebo oral daily"
1080443|NCT00613626|O2|Outcome|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
1080444|NCT00613626|O1|Outcome|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~Placebo: Matched placebo oral daily"
1080445|NCT00613626|O2|Outcome|Arm B: ZD6474 + Safety Lead-In|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
1080446|NCT00613626|O1|Outcome|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~Placebo: Matched placebo oral daily"
1080447|NCT00613626|O2|Outcome|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
1080448|NCT00613626|O1|Outcome|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~Placebo: Matched placebo oral daily"
1080545|NCT00613314|E1|Reported Event|Telmisartan (Micardis)|
1084997|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
1080449|NCT00613626|E2|Reported Event|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
1080450|NCT00613626|E1|Reported Event|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~Placebo: Matched placebo oral daily"
1080451|NCT00613574|B1|Baseline|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
1080452|NCT00613574|P1|Participant Flow|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
1080453|NCT00613574|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
1080454|NCT00613574|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
1080455|NCT00613574|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
1080456|NCT00613574|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
1080457|NCT00613574|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
1080458|NCT00613574|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
1080459|NCT00613574|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
1080460|NCT00613574|E1|Reported Event|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
1080461|NCT00613509|B3|Baseline|Total|Total of all reporting groups
1080462|NCT00613509|B2|Baseline|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
1080463|NCT00613509|B1|Baseline|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
1080464|NCT00613509|P2|Participant Flow|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
1080465|NCT00613509|P1|Participant Flow|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
1080466|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
1080467|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
1080468|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
1080469|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
1080470|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
1080471|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
1080472|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
1080473|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
1080474|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
1080475|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
1080476|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
1080477|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
1080478|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
1080481|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
1080482|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
1080483|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
1080484|NCT00613509|E2|Reported Event|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
1080485|NCT00613509|E1|Reported Event|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
1080486|NCT00613405|B3|Baseline|Total|Total of all reporting groups
1080487|NCT00613405|B2|Baseline|No Stress|Participants assigned to this group are required to read magazines for ten minutes. They then complete a cue exposure session involving both neutral and marijuana-related cues.
1080488|NCT00613405|B1|Baseline|Stress|Participants assigned to this group are required to complete the Trier Social Stress Task, which involves delivering a 5-minute speech and performing a 5-minute math problem in front of an audience. They then complete a cue exposure session involving both neutral and marijuana-related cues.
1080489|NCT00613405|P2|Participant Flow|No Stress|Participants assigned to this group are required to read magazines for ten minutes. They then complete a cue exposure session involving both neutral and marijuana-related cues.
1080490|NCT00613405|P1|Participant Flow|Stress|Participants assigned to this group are required to complete the Trier Social Stress Task, which involves delivering a 5-minute speech and performing a 5-minute math problem in front of an audience. They then complete a cue exposure session involving both neutral and marijuana-related cues.
1080491|NCT00613405|O2|Outcome|No Stress|Participants assigned to this group are required to read magazines for ten minutes. They then complete a cue exposure session involving both neutral and marijuana-related cues.
1080492|NCT00613405|O1|Outcome|Stress|Participants assigned to this group are required to complete the Trier Social Stress Task, which involves delivering a 5-minute speech and performing a 5-minute math problem in front of an audience. They then complete a cue exposure session involving both neutral and marijuana-related cues.
1080493|NCT00613405|E2|Reported Event|No Stress|Participants assigned to this group are required to read magazines for ten minutes. They then complete a cue exposure session involving both neutral and marijuana-related cues.
1080494|NCT00613405|E1|Reported Event|Stress|Participants assigned to this group are required to complete the Trier Social Stress Task, which involves delivering a 5-minute speech and performing a 5-minute math problem in front of an audience. They then complete a cue exposure session involving both neutral and marijuana-related cues.
1080495|NCT00613379|B4|Baseline|Total|Total of all reporting groups
1080496|NCT00613379|B3|Baseline|Arm 3|PBO, one IV dose (N=10)
1080497|NCT00613379|B2|Baseline|Arm 2|5 mg/kg PRO 140, one IV dose (N=10)
1080498|NCT00613379|B1|Baseline|Arm 1|10 mg/kg PRO 140, one IV dose (N=10)
1080499|NCT00613379|P3|Participant Flow|Arm 3|PBO, one IV dose (N=10)
1080500|NCT00613379|P2|Participant Flow|Arm 2|5 mg/kg PRO 140, one IV dose (N=10)
1080501|NCT00613379|P1|Participant Flow|Arm 1|10 mg/kg PRO 140, one IV dose (N=10)
1080502|NCT00613379|O3|Outcome|Arm 3|PBO, one IV dose (N=10)
1080503|NCT00613379|O2|Outcome|Arm 2|5 mg/kg PRO 140, one IV dose (N=10)
1080504|NCT00613379|O1|Outcome|Arm 1|10 mg/kg PRO 140, one IV dose (N=10)
1080505|NCT00613379|E3|Reported Event|Arm 3|PBO, one IV dose (N=10)
1080506|NCT00613379|E2|Reported Event|Arm 2|5 mg/kg PRO 140, one IV dose (N=10)
1080507|NCT00613379|E1|Reported Event|Arm 1|10 mg/kg PRO 140, one IV dose (N=10)
1080508|NCT00613366|B3|Baseline|Total|Total of all reporting groups
1080509|NCT00613366|B2|Baseline|Placebo|Placebo buccal 90 minutes prior to IUD insertion.
1080510|NCT00613366|B1|Baseline|Active Drug (Misoprostol)|400mcg of buccal misoprostol 90 minutes prior to IUD insertion
1080511|NCT00613366|P2|Participant Flow|Placebo|Placebo buccal 90 minutes prior to IUD insertion.
1080512|NCT00613366|P1|Participant Flow|Active Drug (Misoprostol)|400mcg of buccal misoprostol 90 minutes prior to IUD insertion
1080513|NCT00613366|O2|Outcome|Placebo|Placebo buccal 90 minutes prior to IUD insertion.
1080514|NCT00613366|O1|Outcome|Active Drug (Misoprostol)|400mcg of buccal misoprostol 90 minutes prior to IUD insertion
1080515|NCT00613366|O2|Outcome|Placebo|Placebo buccal 90 minutes prior to IUD insertion.
1080516|NCT00613366|O1|Outcome|Active Drug (Misoprostol)|400mcg of buccal misoprostol 90 minutes prior to IUD insertion
1080517|NCT00613366|E2|Reported Event|Placebo|Placebo buccal 90 minutes prior to IUD insertion.
1080518|NCT00613366|E1|Reported Event|Active Drug (Misoprostol)|400mcg of buccal misoprostol 90 minutes prior to IUD insertion
1080519|NCT00613327|B1|Baseline|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
1084998|NCT00603525|O1|Outcome|Placebo|
1080520|NCT00613327|P1|Participant Flow|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
1080548|NCT00613301|O1|Outcome|Pramipexole|BI-Sifrol® Tablets dose: 0.125 mg, 0.5 mg mode of administration: oral
1080521|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
1080522|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
1080523|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
1080524|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
1080525|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
1080526|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
1080527|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
1080528|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
1080529|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
1080530|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
1080531|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
1080532|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
1080533|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
1080534|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
1080535|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
1080536|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
1080537|NCT00613327|E1|Reported Event|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
1080538|NCT00613314|B1|Baseline|Telmisartan (Micardis)|
1080539|NCT00613314|P1|Participant Flow|Telmisartan (Micardis)|
1080540|NCT00613314|O1|Outcome|Telmisartan (Micardis)|
1080546|NCT00613301|B1|Baseline|Pramipexole|The number of patients enrolled was 416. The number of case report form which were collected was 364. Moreover the number of patients analyzed as safety analysis was 346 because 18 patients were excluded due to protocol violations.
1080547|NCT00613301|P1|Participant Flow|Pramipexole|BI-Sifrol® Tablets dose: 0.125 mg, 0.5 mg mode of administration: oral
1080549|NCT00613301|O1|Outcome|Pramipexole|BI-Sifrol® Tablets dose: 0.125 mg, 0.5 mg mode of administration: oral
1080550|NCT00613301|O1|Outcome|Pramipexole|BI-Sifrol® Tablets dose: 0.125 mg, 0.5 mg mode of administration: oral
1080551|NCT00613301|O1|Outcome|Pramipexole|Substance (INN): Pramipexole Trade name: BI-Sifrol® Pharmaceutical form: Tablet Source: Marketed products (There was no investigational products in this PMS) Unit strength: 0.125 mg and 0.5 mg Daily dose: Approved dose range (From 0.25 mg/day to 4.5 mg/day) Duration of use: 3 years Route of administration: Orally
1080552|NCT00613301|E1|Reported Event|Pramipexole|The drug was administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
1080553|NCT00613106|B3|Baseline|Total|Total of all reporting groups
1080554|NCT00613106|B2|Baseline|Ibuprofen|Ibuprofen 800mg
1080555|NCT00613106|B1|Baseline|HZT-501 (Ibuprofen/Famotidine)|HZT-501: ibuprofen 800mg/famotidine 26.6mg
1080556|NCT00613106|P2|Participant Flow|Ibuprofen|Ibuprofen 800mg
1080557|NCT00613106|P1|Participant Flow|HZT-501 (Ibuprofen/Famotidine)|HZT-501: ibuprofen 800mg/famotidine 26.6mg
1080558|NCT00613106|O2|Outcome|Ibuprofen|Ibuprofen 800mg
1080559|NCT00613106|O1|Outcome|HZT-501 (Ibuprofen/Famotidine)|HZT-501: ibuprofen 800mg/famotidine 26.6mg
1080560|NCT00613106|E2|Reported Event|Ibuprofen|Ibuprofen 800mg
1080561|NCT00613106|E1|Reported Event|HZT-501 (Ibuprofen/Famotidine)|HZT-501: ibuprofen 800mg/famotidine 26.6mg
1080562|NCT00613080|B1|Baseline|IMRT + Chemotherapy , Resection, Postoperative Chemotherapy|Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
1080563|NCT00613080|P1|Participant Flow|IMRT + Chemotherapy , Resection, Postoperative Chemotherapy|Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
1080564|NCT00613080|O1|Outcome|IMRT + Chemotherapy , Resection, Postoperative Chemotherapy|Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
1080565|NCT00613080|E1|Reported Event|IMRT + Chemotherapy , Resection, Postoperative Chemotherapy|Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
1080566|NCT00613028|B3|Baseline|Total|Total of all reporting groups
1080567|NCT00613028|B2|Baseline|Etoposide Arm|Pts treated w Bev + Etoposide
1080568|NCT00613028|B1|Baseline|Temozolomide Arm|Pts treated w Bev + Temozolomide
1080569|NCT00613028|P2|Participant Flow|Etoposide Arm|Bevacizumab + Etoposide: Patients who progressed or had grade 3 or greater toxicity related to prior daily temozolomide dosing, but have not had prior progression or grade 3 or greater toxicity related to prior daily etoposide therapy. Patients who have not had prior progression or grade 3 or greater toxicity with either daily temozolomide or etoposide or who have no prior exposure to either will be randomized to one of the groups. Bevacizumab will be administered intravenously at 10mg/kg every other week. Etoposide will be administered once daily at 50 mg/m^2/day for the first 21 days of each 28-day cycle.
1080570|NCT00613028|P1|Participant Flow|Temozolomide Arm|Bevacizumab + Temozolomide: Patients who progressed or had grade 3 or greater toxicity related to prior daily etoposide dosing, but have not had prior progression or grade 3 toxicity related to prior daily temozolomide therapy. Patients who have not had prior progression or grade 3 or greater toxicity with either daily temozolomide or etoposide or who have no prior exposure to either will be randomized to one of the groups. Bevacizumab will be administered intravenously at 10mg/kg every other week. Temozolomide will be administered ona continuous daily dosing schedule at 50 mg/m^2/day.
1080571|NCT00613028|O2|Outcome|Etoposide Arm|Pts treated w Bev + Etoposide
1080572|NCT00613028|O1|Outcome|Temozolomide Arm|Pts treated w Bev + Temozolomide
1080573|NCT00613028|O2|Outcome|Etoposide Arm|Pts treated w Bev + Etoposide
1080574|NCT00613028|O1|Outcome|Temozolomide Arm|Pts treated w Bev + Temozolomide
1080575|NCT00613028|O2|Outcome|Etoposide Arm|Pts treated w Bev + Etoposide
1080576|NCT00613028|O1|Outcome|Temozolomide Arm|Pts treated w Bev + Temozolomide
1080577|NCT00613028|O2|Outcome|Etoposide Arm|Pts treated w Bev + Etoposide
1080578|NCT00613028|O1|Outcome|Temozolomide Arm|Pts treated w Bev + Temozolomide
1080579|NCT00613028|O2|Outcome|Etoposide Arm|Pts treated w Bev + Etoposide
1080580|NCT00613028|O1|Outcome|Temozolomide Arm|Pts treated w Bev + Temozolomide
1080581|NCT00613028|E2|Reported Event|Etoposide Arm|Pts treated w Bev + Etoposide
1080582|NCT00613028|E1|Reported Event|Temozolomide Arm|Pts treated w Bev + Temozolomide
1080583|NCT00613015|B7|Baseline|Total|Total of all reporting groups
1080584|NCT00613015|B6|Baseline|Placebo/No Stress|Participants received placebo for 3 days and did not complete the TRIER social stress task on the third day.
1080585|NCT00613015|B5|Baseline|Placebo/Stress|Participants received placebo for 3 days and completed the TRIER social stress task on the third day.
1080586|NCT00613015|B4|Baseline|Guanfacine/No Stress|Participants received placebo for 2 days, guanfacine for 1 day, and did not complete the TRIER social stress task on the third day.
1080587|NCT00613015|B3|Baseline|Guanfacine/Stress|Participants received placebo for 2 days, guanfacine for 1 day, and completed the TRIER social stress task on the third day.
1080588|NCT00613015|B2|Baseline|Modafinil/No Stress|Participants received modafinil for 3 days and did not complete the TRIER social stress task on the third day.
1080589|NCT00613015|B1|Baseline|Modafinil/Stress|Participants received Modafinil for three days and completed a TRIER social stress task on the third day.
1080590|NCT00613015|P6|Participant Flow|Placebo/No Stress|Participants received placebo for 3 days and did not complete the TRIER social stress task on the third day.
1080591|NCT00613015|P5|Participant Flow|Placebo/Stress|Participants received placebo for 3 days and completed the TRIER social stress task on the third day.
1080592|NCT00613015|P4|Participant Flow|Guanfacine/No Stress|Participants received placebo for 2 days, guanfacine for 1 day, and did not complete the TRIER social stress task on the third day.
1080593|NCT00613015|P3|Participant Flow|Guanfacine/Stress|Participants received placebo for 2 days, guanfacine for 1 day, and completed the TRIER social stress task on the third day.
1080594|NCT00613015|P2|Participant Flow|Modafinil/No Stress|Participants received modafinil for 3 days and did not complete the TRIER social stress task on the third day.
1080595|NCT00613015|P1|Participant Flow|Modafinil/Stress|Participants received Modafinil for three days and completed a TRIER social stress task on the third day.
1080596|NCT00613015|O6|Outcome|Placebo/No Stress|Participants received placebo for 3 days and did not complete the TRIER social stress task on the third day.
1080597|NCT00613015|O5|Outcome|Placebo/Stress|Participants received placebo for 3 days and completed the TRIER social stress task on the third day.
1080598|NCT00613015|O4|Outcome|Guanfacine/No Stress|Participants received placebo for 2 days, guanfacine for 1 day, and did not complete the TRIER social stress task on the third day.
1080599|NCT00613015|O3|Outcome|Guanfacine/Stress|Participants received placebo for 2 days, guanfacine for 1 day, and completed the TRIER social stress task on the third day.
1080600|NCT00613015|O2|Outcome|Modafinil/No Stress|Participants received modafinil for 3 days and did not complete the TRIER social stress task on the third day.
1080601|NCT00613015|O1|Outcome|Modafinil/Stress|Participants received Modafinil for three days and completed a TRIER social stress task on the third day.
1080602|NCT00613015|O6|Outcome|Placebo/No Stress|Participants received placebo for 3 days and did not complete the TRIER social stress task on the third day.
1080603|NCT00613015|O5|Outcome|Placebo/Stress|Participants received placebo for 3 days and completed the TRIER social stress task on the third day.
1080604|NCT00613015|O4|Outcome|Guanfacine/No Stress|Participants received placebo for 2 days, guanfacine for 1 day, and did not complete the TRIER social stress task on the third day.
1080605|NCT00613015|O3|Outcome|Guanfacine/Stress|Participants received placebo for 2 days, guanfacine for 1 day, and completed the TRIER social stress task on the third day.
1080606|NCT00613015|O2|Outcome|Modafinil/No Stress|Participants received modafinil for 3 days and did not complete the TRIER social stress task on the third day.
1080607|NCT00613015|O1|Outcome|Modafinil/Stress|Participants received Modafinil for three days and completed a TRIER social stress task on the third day.
1080608|NCT00613015|E6|Reported Event|Placebo/No Stress|Participants received placebo for 3 days and did not complete the TRIER social stress task on the third day.
1080609|NCT00613015|E5|Reported Event|Placebo/Stress|Participants received placebo for 3 days and completed the TRIER social stress task on the third day.
1080610|NCT00613015|E4|Reported Event|Guanfacine/No Stress|Participants received placebo for 2 days, guanfacine for 1 day, and did not complete the TRIER social stress task on the third day.
1080611|NCT00613015|E3|Reported Event|Guanfacine/Stress|Participants received placebo for 2 days, guanfacine for 1 day, and completed the TRIER social stress task on the third day.
1080612|NCT00613015|E2|Reported Event|Modafinil/No Stress|Participants received modafinil for 3 days and did not complete the TRIER social stress task on the third day.
1080613|NCT00613015|E1|Reported Event|Modafinil/Stress|Participants received Modafinil for three days and completed a TRIER social stress task on the third day.
1080614|NCT00612924|B3|Baseline|Total|Total of all reporting groups
1080615|NCT00612924|B2|Baseline|ONE-LOK|
1080616|NCT00612924|B1|Baseline|Anaconda|The original protocol identified that the Anaconda™ Stent Graft System would be used throughout the current Phase II study. However, a modified device design became available during the course of the current Phase II study and is called the ONELOK™ Stent Graft System. As the modifications to the device design are considered minor, there are no expected differences in the anticipated safety or effectiveness of the device. The design changes relate primary to a uni-docking zone in the bifurcate body to maximize sizing compatibilities between the bifurcate body and the iliac limbs.
1080617|NCT00612924|P2|Participant Flow|ONE-LOK|
1080618|NCT00612924|P1|Participant Flow|Anaconda|
1080619|NCT00612924|O2|Outcome|ONE LOK|
1080620|NCT00612924|O1|Outcome|Anaconda|
1080621|NCT00612924|O3|Outcome|Total|
1080622|NCT00612924|O2|Outcome|ONE LOK|
1080623|NCT00612924|O1|Outcome|Anaconda|
1080624|NCT00612924|O2|Outcome|ONE LOK|
1080625|NCT00612924|O1|Outcome|Anaconda|
1080626|NCT00612924|E2|Reported Event|ONE-LOK|
1080627|NCT00612924|E1|Reported Event|Anaconda|
1080628|NCT00612807|B3|Baseline|Total|Total of all reporting groups
1080629|NCT00612807|B2|Baseline|Semi-weekly Medication Management + Weekly Marital Therapy|Medication management with a study doctor every other week plus weekly marital therapy.
1080630|NCT00612807|B1|Baseline|Semi-weekly Medication Management|Medication management with a study doctor every other week.
1080631|NCT00612807|P2|Participant Flow|Semi-weekly Medication Management + Weekly Marital Therapy|Medication management with a study doctor every other week plus weekly marital therapy.
1080632|NCT00612807|P1|Participant Flow|Semi-weekly Medication Management|Medication management with a study doctor every other week.
1080633|NCT00612807|O2|Outcome|Semi-weekly Medication Management + Weekly Marital Therapy|Medication management with a study doctor every other week plus weekly marital therapy.
1080634|NCT00612807|O1|Outcome|Semi-weekly Medication Management|Medication management with a study doctor every other week.
1080635|NCT00612807|O2|Outcome|Semi-weekly Medication Management + Weekly Marital Therapy|Medication management with a study doctor every other week plus weekly marital therapy.
1080636|NCT00612807|O1|Outcome|Semi-weekly Medication Management|Medication management with a study doctor every other week.
1080735|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080637|NCT00612807|E2|Reported Event|Semi-weekly Medication Management + Weekly Marital Therapy|Medication management with a study doctor every other week plus weekly marital therapy.
1080638|NCT00612807|E1|Reported Event|Semi-weekly Medication Management|Medication management with a study doctor every other week.
1080639|NCT00612690|B3|Baseline|Total|Total of all reporting groups
1080640|NCT00612690|B2|Baseline|Services As Usual|Referral to nearby community mental heath agencies for clinic-based services where participants received standard care for mental health-related problems.
1080641|NCT00612690|B1|Baseline|Links to Learning|Mental health intervention focused on enhancing the predictors of young children's school success
1080642|NCT00612690|P2|Participant Flow|Services as Usual|"Participants received treatment as usual and referrals.~Treatment as usual (TAU) : TAU included referral to community mental health clinic-based services, where participants received standard care for mental health-related problems."
1080643|NCT00612690|P1|Participant Flow|Links to Learning|"Participants underwent the community mental health consultation model program.~Community mental health consultation model program : The community mental health consultation model program included collaboration among community mental health providers and (1) parent advocates to effectively maintain families in a school-based mental health program, (2) classroom teachers to enhance children's academic performance, and (3) peer-identified influential teachers to influence classroom teachers' use of behavior management strategies. This model further focused on the strongest teacher and parent predictors of student learning."
1080644|NCT00612690|O2|Outcome|Services as Usual|"Participants received treatment as usual and referrals.~Treatment as usual (TAU) : TAU included referral to community mental health clinic-based services, where participants received standard care for mental health-related problems."
1080645|NCT00612690|O1|Outcome|Links to Learning|"Participants underwent the community mental health consultation model program.~Community mental health consultation model program : The community mental health consultation model program included collaboration among community mental health providers and (1) parent advocates to effectively maintain families in a school-based mental health program, (2) classroom teachers to enhance children's academic performance, and (3) peer-identified influential teachers to influence classroom teachers' use of behavior management strategies. This model further focuses on the strongest teacher and parent predictors of student learning."
1080646|NCT00612690|O2|Outcome|Services as Usual|"Participants received treatment as usual and referrals.~Treatment as usual (TAU) : TAU included referral to community mental health clinic-based services where participants received standard care for mental health-related problems."
1080647|NCT00612690|O1|Outcome|Links to Learning|"Participants underwent the community mental health consultation model program.~Community mental health consultation model program : The community mental health consultation model program included collaboration among community mental health providers and (1) parent advocates to effectively maintain families in a school-based mental health program, (2) classroom teachers to enhance children's academic performance, and (3) peer-identified influential teachers to influence classroom teachers' use of behavior management strategies. This model further focused on the strongest teacher and parent predictors of student learning."
1080648|NCT00612690|E2|Reported Event|Services as Usual|"Participants will receive treatment as usual and referrals.~Treatment as usual (TAU) : TAU includes referral to community mental health clinic-based services, where participants will receive standard care for mental health-related problems."
1080649|NCT00612690|E1|Reported Event|Links to Learning|"Participants will undergo the community mental health consultation model program.~Community mental health consultation model program : The community mental health consultation model program includes collaboration among community mental health providers and (1) parent advocates to effectively maintain families in a school-based mental health program, (2) classroom teachers to enhance children's academic performance, and (3) peer-identified influential teachers to influence classroom teachers' use of behavior management strategies. This model further focuses on the strongest teacher and parent predictors of student learning."
1080650|NCT00612677|B1|Baseline|Chemotherapy|Single arm, two stage design Phase II study offered through the Moffitt Clinical Research Affiliate Network
1080651|NCT00612677|P1|Participant Flow|Chemotherapy|Single arm, two stage design Phase II study offered through the Moffitt Clinical Research Affiliate Network
1080652|NCT00612677|O1|Outcome|Chemotherapy|Single arm, two stage design Phase II study offered through the Moffitt Clinical Research Affiliate Network
1080653|NCT00612677|O1|Outcome|Chemotherapy|Single arm, two stage design Phase II study offered through the Moffitt Clinical Research Affiliate Network
1080654|NCT00612677|O1|Outcome|Chemotherapy|Single arm, two stage design Phase II study offered through the Moffitt Clinical Research Affiliate Network
1080655|NCT00612677|E1|Reported Event|Chemotherapy|Single arm, two stage design Phase II study offered through the Moffitt Clinical Research Affiliate Network
1080656|NCT00612573|B5|Baseline|Total|Total of all reporting groups
1080657|NCT00612573|B4|Baseline|Placebo Comparator|3 placebo tablets daily matching active 40 & 80 mg tablets
1080658|NCT00612573|B3|Baseline|Doxycycline 2.4 mg/kg/Day|160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
1080659|NCT00612573|B2|Baseline|Doxycycline 1.2 mg/kg/Day|80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
1080660|NCT00612573|B1|Baseline|Doxycycline 0.6 mg/kg/Day|40 mg doxycycline tablet plus 2 placebo tablets daily
1080661|NCT00612573|P4|Participant Flow|Placebo Comparator|3 placebo tablets daily matching active 40 & 80 mg tablets
1080662|NCT00612573|P3|Participant Flow|Doxycycline 2.4 mg/kg/Day|160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
1080663|NCT00612573|P2|Participant Flow|Doxycycline 1.2 mg/kg/Day|80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
1080664|NCT00612573|P1|Participant Flow|Doxycycline 0.6 mg/kg/Day|40 mg doxycycline tablet plus 2 placebo tablets daily
1080665|NCT00612573|O4|Outcome|Placebo Comparator|3 placebo tablets daily matching active 40 & 80 mg tablets
1080666|NCT00612573|O3|Outcome|Doxycycline 2.4 mg/kg/Day|160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
1080667|NCT00612573|O2|Outcome|Doxycycline 1.2 mg/kg/Day|80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
1080668|NCT00612573|O1|Outcome|Doxycycline 0.6 mg/kg/Day|40 mg doxycycline tablet plus 2 placebo tablets daily
1080669|NCT00612573|O4|Outcome|Placebo Comparator|3 placebo tablets daily matching active 40 & 80 mg tablets
1080670|NCT00612573|O3|Outcome|Doxycycline 2.4 mg/kg/Day|160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
1080671|NCT00612573|O2|Outcome|Doxycycline 1.2 mg/kg/Day|80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
1080672|NCT00612573|O1|Outcome|Doxycycline 0.6 mg/kg/Day|40 mg doxycycline tablet plus 2 placebo tablets daily
1080673|NCT00612573|O4|Outcome|Placebo Comparator|3 placebo tablets daily matching active 40 & 80 mg tablets
1080674|NCT00612573|O3|Outcome|Doxycycline 2.4 mg/kg/Day|160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
1080675|NCT00612573|O2|Outcome|Doxycycline 1.2 mg/kg/Day|80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
1080676|NCT00612573|O1|Outcome|Doxycycline 0.6 mg/kg/Day|40 mg doxycycline tablet plus 2 placebo tablets daily
1080677|NCT00612573|O4|Outcome|Placebo Comparator|3 placebo tablets daily matching active 40 & 80 mg tablets
1080678|NCT00612573|O3|Outcome|Doxycycline 2.4 mg/kg/Day|160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
1080679|NCT00612573|O2|Outcome|Doxycycline 1.2 mg/kg/Day|80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
1080680|NCT00612573|O1|Outcome|Doxycycline 0.6 mg/kg/Day|40 mg doxycycline tablet plus 2 placebo tablets daily
1080681|NCT00612573|E4|Reported Event|Placebo Comparator|3 placebo tablets daily matching active 40 & 80 mg tablets
1080682|NCT00612573|E3|Reported Event|Doxycycline 2.4 mg/kg/Day|160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
1080683|NCT00612573|E2|Reported Event|Doxycycline 1.2 mg/kg/Day|80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
1080684|NCT00612573|E1|Reported Event|Doxycycline 0.6 mg/kg/Day|40 mg doxycycline tablet plus 2 placebo tablets daily
1080685|NCT00612534|B5|Baseline|Total|Total of all reporting groups
1080686|NCT00612534|B4|Baseline|Placebo NanoTab|
1080687|NCT00612534|B3|Baseline|Sufentanil NanoTab 15 Mcg|
1080688|NCT00612534|B2|Baseline|Sufentanil NanoTab 10 Mcg|
1080689|NCT00612534|B1|Baseline|Sufentanil NanoTab 5 Mcg|
1080690|NCT00612534|P4|Participant Flow|Placebo NanoTab|
1080691|NCT00612534|P3|Participant Flow|Sufentanil NanoTab 15 Mcg|
1080692|NCT00612534|P2|Participant Flow|Sufentanil NanoTab 10 Mcg|
1080693|NCT00612534|P1|Participant Flow|Sufentanil NanoTab 5 Mcg|
1080694|NCT00612534|O4|Outcome|Placebo NanoTab|
1080695|NCT00612534|O3|Outcome|Sufentanil NanoTab 15 Mcg|
1080696|NCT00612534|O2|Outcome|Sufentanil NanoTab 10 Mcg|
1080697|NCT00612534|O1|Outcome|Sufentanil NanoTab 5 Mcg|
1080698|NCT00612534|E4|Reported Event|Placebo NanoTab|
1080699|NCT00612534|E3|Reported Event|Sufentanil NanoTab 15 Mcg|
1080700|NCT00612534|E2|Reported Event|Sufentanil NanoTab 10 Mcg|
1080701|NCT00612534|E1|Reported Event|Sufentanil NanoTab 5 Mcg|
1080702|NCT00612508|B3|Baseline|Total|Total of all reporting groups
1080703|NCT00612508|B2|Baseline|NuvaRing|intravaginal contraception
1080704|NCT00612508|B1|Baseline|Desogen|oral contraceptive
1080705|NCT00612508|P2|Participant Flow|NuvaRing|intravaginal contraception
1080706|NCT00612508|P1|Participant Flow|Desogen|oral contraceptive
1080707|NCT00612508|O2|Outcome|Intravaginal Ring Contraceptive|nuvaring (ethinyl estradiol & desogestrel) = R (ring)
1080708|NCT00612508|O1|Outcome|Oral Contraceptive|Desogen (ethinyl estradiol & desogestrel) = P (pill)
1080709|NCT00612508|O2|Outcome|NuvaRing|intravaginal contraception = R (ring)
1080710|NCT00612508|O1|Outcome|Desogen|oral contraceptive = P (pill)
1080711|NCT00612508|E2|Reported Event|NuvaRing|intravaginal contraception
1080712|NCT00612508|E1|Reported Event|Desogen|oral contraceptive
1080713|NCT00612430|B3|Baseline|Total|Total of all reporting groups
1080714|NCT00612430|B2|Baseline|Grade IV|
1080715|NCT00612430|B1|Baseline|Grade III|
1080716|NCT00612430|P2|Participant Flow|Grade IV|Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1stbevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day
1080717|NCT00612430|P1|Participant Flow|Grade III|Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1stbevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day
1080718|NCT00612430|O2|Outcome|Grade IV|
1080719|NCT00612430|O1|Outcome|Grade III|
1080720|NCT00612430|O2|Outcome|Grade IV|
1080721|NCT00612430|O1|Outcome|Grade III|
1080722|NCT00612430|O2|Outcome|Grade IV|
1080723|NCT00612430|O1|Outcome|Grade III|
1080724|NCT00612430|O2|Outcome|Grade IV|
1080725|NCT00612430|O1|Outcome|Grade III|
1080726|NCT00612430|O2|Outcome|Grade IV|Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1stbevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day
1080727|NCT00612430|O1|Outcome|Grade III|Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1stbevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day
1080728|NCT00612430|E2|Reported Event|Grade IV|
1080729|NCT00612430|E1|Reported Event|Grade III|
1080730|NCT00612352|B3|Baseline|Total|Total of all reporting groups
1080731|NCT00612352|B2|Baseline|Family History Negative|Subjects with no family history of alcoholism.
1080732|NCT00612352|B1|Baseline|Family History Positive|Subjects with a positive family history of alcoholism.
1080733|NCT00612352|P2|Participant Flow|Family History Negative|Subjects with no family history of alcoholism.
1080734|NCT00612352|P1|Participant Flow|Family History Positive|Subjects with a positive family history of alcoholism.
1084999|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
1080736|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080737|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080738|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080739|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080740|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080741|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080742|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080743|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080744|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080745|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080746|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080747|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080748|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080749|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080750|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080751|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080752|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080753|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080754|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080755|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080756|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080757|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080758|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080759|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080760|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080761|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080762|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080763|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080764|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080765|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080766|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080767|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080768|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080769|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080770|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080771|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080772|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080773|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080774|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080775|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080776|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080777|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080778|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080779|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080780|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080781|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080782|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080783|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080784|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080785|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080786|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080787|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080788|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080789|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080790|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080791|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080792|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080793|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080794|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080795|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080796|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080797|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080798|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080799|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080800|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080801|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080802|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080803|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080804|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080805|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080806|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080807|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080808|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080809|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080810|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080811|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080812|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080813|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080814|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080815|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080816|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080817|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080818|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080819|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080820|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080821|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080822|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080823|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080824|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080825|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080826|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080827|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080828|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080829|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080830|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080831|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080832|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080833|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080834|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080835|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080836|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080837|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080838|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080839|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080840|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080841|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080842|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080843|NCT00612352|O2|Outcome|Family History Negative|Subjects with no family history of alcoholism.
1080844|NCT00612352|O1|Outcome|Family History Positive|Subjects with a positive family history of alcoholism.
1080845|NCT00612352|E2|Reported Event|Family History Negative|Subjects with no family history of alcoholism.
1080846|NCT00612352|E1|Reported Event|Family History Positive|Subjects with a positive family history of alcoholism.
1080847|NCT00612339|B1|Baseline|Avastin and Temozolomide|Avastin administered at 10 mg/kg every 2 weeks beginning a minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in a 28-day cycle.
1080848|NCT00612339|P1|Participant Flow|Avastin and Temozolomide|Avastin administered at 10 mg/kg every 2 weeks beginning a minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in a 28-day cycle.
1080849|NCT00612339|O1|Outcome|Avastin and Temozolomide|Avastin administered at 10 mg/kg every 2 weeks beginning a minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in a 28-day cycle.
1080850|NCT00612339|E1|Reported Event|Avastin and Temozolomide|Avastin administered at 10 mg/kg every 2 weeks beginning a minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in a 28-day cycle.
1080851|NCT00612313|B3|Baseline|Total|Total of all reporting groups
1080941|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080852|NCT00612313|B2|Baseline|Continued Medication Plus CBT|"Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants attended 10 to 12 CBT sessions, during which they will learn specific skills to reduce and prevent the occurrence of residual depressive symptoms."
1080853|NCT00612313|B1|Baseline|Continued Medication Alone|"Participants received antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks."
1080854|NCT00612313|P2|Participant Flow|Continued Medication Plus CBT|"n=75 Participants will receive antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, some participants will be assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they will learn specific skills to reduce and prevent the occurrence of residual depressive symptoms."
1080855|NCT00612313|P1|Participant Flow|Continued Medication Alone|"n=69 Participants will receive antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks."
1080856|NCT00612313|O2|Outcome|Continued Medication Plus CBT|"Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they learned specific skills to reduce and prevent the occurrence of residual depressive symptoms."
1080857|NCT00612313|O1|Outcome|Continued Medication Alone|"Participants received antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks."
1080858|NCT00612313|O2|Outcome|Continued Medication Plus CBT|"Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they learned specific skills to reduce and prevent the occurrence of residual depressive symptoms.~Treatment was uncontrolled after week 30."
1080859|NCT00612313|O1|Outcome|Continued Medication Alone|"Participants received antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~Treatment was uncontrolled after week 30."
1080860|NCT00612313|O2|Outcome|Continued Medication Plus CBT|"Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they learned specific skills to reduce and prevent the occurrence of residual depressive symptoms.~Treatment was uncontrolled after week 30."
1080861|NCT00612313|O1|Outcome|Continued Medication Alone|"Participants received antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~Treatment was uncontrolled after week 30."
1080862|NCT00612313|O2|Outcome|Continued Medication Plus CBT|"Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they learned specific skills to reduce and prevent the occurrence of residual depressive symptoms.~n=75"
1080863|NCT00612313|O1|Outcome|Continued Medication Alone|"Participants received antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~n=69"
1080864|NCT00612313|O2|Outcome|Continued Medication Plus CBT|"Participants will receive antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, some participants will be assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they will learn specific skills to reduce and prevent the occurrence of residual depressive symptoms."
1080865|NCT00612313|O1|Outcome|Continued Medication Alone|"Participants will receive antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks."
1080866|NCT00612313|O2|Outcome|Continued Medication Plus CBT|"Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they learned specific skills to reduce and prevent the occurrence of residual depressive symptoms."
1080867|NCT00612313|O1|Outcome|Continued Medication Alone|"Participants received antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks."
1080868|NCT00612313|E2|Reported Event|Continued Medication Plus CBT|"Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they learned specific skills to reduce and prevent the occurrence of residual depressive symptoms.~N=75"
1080869|NCT00612313|E1|Reported Event|Continued Medication Alone|"Participants received antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~N=69"
1080870|NCT00612222|B1|Baseline|ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2|"ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days."
1080871|NCT00612222|P1|Participant Flow|ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2|"ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days."
1080872|NCT00612222|O1|Outcome|ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2|"ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days."
1080873|NCT00612222|O1|Outcome|ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2|"ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days."
1080874|NCT00612222|O1|Outcome|ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2|"ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days."
1080875|NCT00612222|E1|Reported Event|ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2|"ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days."
1080876|NCT00612105|B3|Baseline|Total|Total of all reporting groups
1080877|NCT00612105|B2|Baseline|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
1080878|NCT00612105|B1|Baseline|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
1080879|NCT00612105|P2|Participant Flow|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
1080880|NCT00612105|P1|Participant Flow|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
1080881|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
1080990|NCT00611897|O3|Outcome|NAC+Saline|NAC active capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
1080882|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
1080883|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
1080884|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
1080885|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
1080886|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
1080887|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
1080888|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
1080889|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
1080890|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
1080891|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
1080892|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
1080893|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
1080935|NCT00612040|B2|Baseline|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080936|NCT00612040|B1|Baseline|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080894|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
1080895|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
1080896|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
1080897|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
1080898|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
1080899|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
1080900|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
1080901|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
1080902|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant's MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
1080903|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
1080904|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
1080905|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
1080937|NCT00612040|P3|Participant Flow|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080938|NCT00612040|P2|Participant Flow|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080906|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
1080907|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
1080908|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
1080909|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
1080910|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
1080911|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
1080912|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
1080913|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
1080914|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
1080915|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
1080916|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
1080917|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
1080939|NCT00612040|P1|Participant Flow|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080940|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080918|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
1080919|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
1080920|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
1080921|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
1080922|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
1080923|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
1080924|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
1080925|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
1080926|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
1080927|NCT00612105|E2|Reported Event|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
1080928|NCT00612105|E1|Reported Event|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
1080929|NCT00612066|B1|Baseline|Rosiglitazone|Rosiglitazone maleate :
1080930|NCT00612066|P1|Participant Flow|Rosiglitazone|Rosiglitazone maleate :
1080931|NCT00612066|O1|Outcome|Rosiglitazone|Rosiglitazone maleate :
1080932|NCT00612066|E1|Reported Event|Rosiglitazone|Rosiglitazone maleate :
1080933|NCT00612040|B4|Baseline|Total|Total of all reporting groups
1080934|NCT00612040|B3|Baseline|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080991|NCT00611897|O2|Outcome|Placebo+Ketamine|NAC placebo capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
1080942|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080943|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080944|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080945|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080946|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080947|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080948|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080949|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080950|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080951|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080952|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080953|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080954|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080955|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080956|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080957|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080958|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080959|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080960|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080961|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080962|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080963|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080964|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1081092|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1080965|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080966|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080967|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080968|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080969|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080970|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080971|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080972|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080973|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080974|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080975|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080976|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080977|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080978|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080979|NCT00612040|E3|Reported Event|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080980|NCT00612040|E2|Reported Event|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080981|NCT00612040|E1|Reported Event|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
1080982|NCT00611897|B1|Baseline|Overall Sample|This is the group of healthy volunteers that consented to participate in the study.
1080983|NCT00611897|P2|Participant Flow|Day 1: Placebo NAC; Day 2: Active NAC|Subjects were randomized to receive PLACEBO NAC on day one, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order. Subjects then received ACTIVE NAC on day two, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order.
1080984|NCT00611897|P1|Participant Flow|Day 1: Active NAC; Day 2: Placebo NAC|Subjects were randomized to receive ACTIVE NAC on day one, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order. Subjects then received PLACEBO NAC on day two, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order.
1080985|NCT00611897|O4|Outcome|NAC+Ketamine|NAC active capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
1080986|NCT00611897|O3|Outcome|NAC+Saline|NAC active capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
1080987|NCT00611897|O2|Outcome|Placebo+Ketamine|NAC placebo capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
1080988|NCT00611897|O1|Outcome|Placebo+Saline|NAC placebo capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
1080989|NCT00611897|O4|Outcome|NAC+Ketamine|NAC active capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
1081094|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1080992|NCT00611897|O1|Outcome|Placebo+Saline|NAC placebo capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
1080993|NCT00611897|O4|Outcome|NAC+Ketamine|NAC active capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
1080994|NCT00611897|O3|Outcome|NAC+Saline|NAC active capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
1080995|NCT00611897|O2|Outcome|Placebo+Ketamine|NAC placebo capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
1080996|NCT00611897|O1|Outcome|Placebo+Saline|NAC placebo capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
1080997|NCT00611897|O4|Outcome|NAC+Ketamine|NAC active capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
1080998|NCT00611897|O3|Outcome|NAC+Saline|NAC active capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
1080999|NCT00611897|O2|Outcome|Placebo+Ketamine|NAC placebo capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
1081000|NCT00611897|O1|Outcome|Placebo+Saline|NAC placebo capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
1081001|NCT00611897|O4|Outcome|NAC+Ketamine|NAC active capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
1081002|NCT00611897|O3|Outcome|NAC+Saline|NAC active capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
1081003|NCT00611897|O2|Outcome|Placebo+Ketamine|NAC placebo capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
1081004|NCT00611897|O1|Outcome|Placebo+Saline|NAC placebo capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
1081005|NCT00611897|E2|Reported Event|Day 1: Active NAC; Day 2: Placebo NAC|Subjects were randomized to receive ACTIVE NAC on day one, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order. Subjects then received PLACEBO NAC on day two, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order.
1081006|NCT00611897|E1|Reported Event|Day 1: Placebo NAC; Day 2: Active NAC|Subjects were randomized to receive PLACEBO NAC on day one, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order. Subjects then received ACTIVE NAC on day two, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order.
1081007|NCT00611884|B5|Baseline|Total|Total of all reporting groups
1081008|NCT00611884|B4|Baseline|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
1081009|NCT00611884|B3|Baseline|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
1081010|NCT00611884|B2|Baseline|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
1081011|NCT00611884|B1|Baseline|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
1081012|NCT00611884|P4|Participant Flow|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
1081013|NCT00611884|P3|Participant Flow|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
1081014|NCT00611884|P2|Participant Flow|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
1081015|NCT00611884|P1|Participant Flow|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
1081016|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
1081017|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
1081018|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
1081095|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081019|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
1081020|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
1081021|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
1081022|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
1081023|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
1081024|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
1081025|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
1081026|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
1081027|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
1081028|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
1081029|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
1081030|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
1081031|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
1081032|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
1081033|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
1081034|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
1081035|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
1081036|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
1081037|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
1081038|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
1081039|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
1081040|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
1081041|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
1081042|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
1081043|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
1081044|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
1081045|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
1081046|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
1081047|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
1081048|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
1081049|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
1081050|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
1081051|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
1081052|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
1081053|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
1081054|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
1081055|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
1081056|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
1081057|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
1081058|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
1081059|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
1081060|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
1081061|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
1081093|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1085000|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
1081062|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
1081063|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
1081064|NCT00611884|E4|Reported Event|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
1081065|NCT00611884|E3|Reported Event|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
1081066|NCT00611884|E2|Reported Event|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
1081067|NCT00611884|E1|Reported Event|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
1081068|NCT00611806|B3|Baseline|Total|Total of all reporting groups
1081069|NCT00611806|B2|Baseline|Placebo|"Participants will take placebo for 18 weeks.~Placebo: 1 capsule po daily"
1081070|NCT00611806|B1|Baseline|Folate With B12|"Participants will take folic acid plus B12 for 18 weeks.~Folic Acid: Folic acid 2mg po daily~B12: B12 400 micrograms po daily"
1081071|NCT00611806|P2|Participant Flow|Placebo|"Participants will take placebo for 18 weeks.~Placebo: 1 capsule po daily"
1081072|NCT00611806|P1|Participant Flow|Folate With B12|"Participants will take folic acid plus B12 for 18 weeks.~Folic Acid: Folic acid 2mg po daily~B12: B12 400 micrograms po daily"
1081073|NCT00611806|O2|Outcome|Placebo|"Participants will take placebo for 18 weeks.~Placebo: 1 capsule po daily"
1081074|NCT00611806|O1|Outcome|Folate With B12|"Participants will take folic acid plus B12 for 18 weeks.~Folic Acid: Folic acid 2mg po daily~B12: B12 400 micrograms po daily"
1081075|NCT00611806|O2|Outcome|Placebo|"Participants will take placebo for 18 weeks.~Placebo: 1 capsule po daily"
1081076|NCT00611806|O1|Outcome|Folate With B12|"Participants will take folic acid plus B12 for 18 weeks.~Folic Acid: Folic acid 2mg po daily~B12: B12 400 micrograms po daily"
1081077|NCT00611806|O2|Outcome|Placebo|"Participants will take placebo for 18 weeks.~Placebo: 1 capsule po daily"
1081078|NCT00611806|O1|Outcome|Folate With B12|"Participants will take folic acid plus B12 for 18 weeks.~Folic Acid: Folic acid 2mg po daily~B12: B12 400 micrograms po daily"
1081079|NCT00611806|O2|Outcome|Placebo|"Participants will take placebo for 18 weeks.~Placebo: 1 capsule po daily"
1081080|NCT00611806|O1|Outcome|Folate With B12|"Participants will take folic acid plus B12 for 18 weeks.~Folic Acid: Folic acid 2mg po daily~B12: B12 400 micrograms po daily"
1081081|NCT00611806|E2|Reported Event|Placebo|"Participants will take placebo for 18 weeks.~Placebo: 1 capsule po daily"
1081082|NCT00611806|E1|Reported Event|Folate With B12|"Participants will take folic acid plus B12 for 18 weeks.~Folic Acid: Folic acid 2mg po daily~B12: B12 400 micrograms po daily"
1081083|NCT00611767|B3|Baseline|Total|Total of all reporting groups
1081084|NCT00611767|B2|Baseline|Family History Positive for Alcoholism|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 30 yrs, medically healthy, who have been absence of any evidence of substance abuse (with the exception of nicotine dependence) diagnosis by the non-patient version of the structured clinical interview (SCID). Biological father and another first or second-degree biological relative with a history of alcoholism by Family History Assessment Module (FHAM) developed by COGA.
1081085|NCT00611767|B1|Baseline|Family History Negative for Alcoholism|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 30 yrs, medically healthy, who have been absence of any evidence of substance abuse (with the exception of nicotine dependence) diagnosis by the non-patient version of the structured clinical interview (SCID). No family history of alcoholism in any first or second-degree relatives.
1081086|NCT00611767|P2|Participant Flow|Family History Positive for Alcoholism|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 30 yrs, medically healthy, who have been absence of any evidence of substance abuse (with the exception of nicotine dependence) diagnosis by the non-patient version of the structured clinical interview (SCID). Biological father and another first or second-degree biological relative with a history of alcoholism by Family History Assessment Module (FHAM) developed by The Collaborative Study on the Genetics of Alcoholism (COGA).
1081087|NCT00611767|P1|Participant Flow|Family History Negative for Alcoholism|Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 30 yrs, medically healthy, who have been absence of any evidence of substance abuse (with the exception of nicotine dependence) diagnosis by the non-patient version of the structured clinical interview (SCID). No family history of alcoholism in any first or second-degree relatives.
1081088|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081089|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081090|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081091|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081096|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081097|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081098|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081099|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081100|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081101|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081102|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081103|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081104|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081105|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081106|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081107|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081108|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081109|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081110|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081111|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081112|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081113|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081114|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081115|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081116|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081117|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081118|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081119|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081120|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081121|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081122|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081123|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081124|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081125|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081126|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081127|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081128|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081129|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081130|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081131|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081132|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081133|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081134|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081135|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081136|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081137|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081138|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081139|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081140|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081141|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081142|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081143|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1085001|NCT00603525|O1|Outcome|Placebo|
1081144|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081145|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081146|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081147|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081148|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081149|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081150|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081151|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081152|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081153|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081154|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081155|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081156|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081157|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081158|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081159|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081160|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081161|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081162|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081163|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081164|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081165|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081166|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081167|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081168|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081169|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081170|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081171|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081172|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081173|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081174|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081175|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081176|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081177|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081178|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081179|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081180|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081181|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081182|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081183|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081184|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081185|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081186|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081187|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081188|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081189|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081190|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081191|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081192|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081705|NCT00610675|O1|Outcome|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
1081242|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081193|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081194|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081195|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081196|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081197|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081198|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081199|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081200|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081201|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081202|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081203|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081204|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081205|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081206|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081207|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081208|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081209|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081210|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081211|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081212|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081213|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081214|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081215|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081216|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081217|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081218|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081219|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081220|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081221|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081222|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081223|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081224|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081225|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081226|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081227|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081228|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081229|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081230|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081231|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081232|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081233|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081234|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081235|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081236|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081237|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081238|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081239|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081240|NCT00611767|O2|Outcome|Family History Positive|Family History Positive for Alcoholism subjects will receive 2 interventions
1081241|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1085002|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
1081243|NCT00611767|O1|Outcome|Family History Negative for Alcoholism|Family History Negative for Alcoholism subjects will receive 2 interventions
1081244|NCT00611767|E2|Reported Event|Family History Positive for Alcoholism|"Family History Positive for Alcoholism subjects will receive 2 interventions~Placebo: A 2-day test design involving 2 conditions: saline (Placebo) or Thiopental 1.5mg/kg (loading) with a subsequent infusion rate of 40 mcg/kg/minute (60 minute infusion)."
1081245|NCT00611767|E1|Reported Event|Family History Negative for Alcoholism|"Family History Negative for Alcoholism subjects will receive 2 interventions~Thiopental: A 2-day test design involving 2 conditions: saline (Placebo) or Thiopental 1.5mg/kg (loading) with a subsequent infusion rate of 40 mcg/kg/minute (60 minute infusion)."
1081246|NCT00611715|B3|Baseline|Total|Total of all reporting groups
1081247|NCT00611715|B2|Baseline|Second-line/Prev Hormone-therapy tx|Patients who have previously received hormonal therapy
1081248|NCT00611715|B1|Baseline|First Line/Hormone-therapy Naive|Patients who have not received hormonal therapy
1081249|NCT00611715|P2|Participant Flow|Second-line/Prev Hormone-therapy tx|Patients who have previously received hormonal therapy
1081250|NCT00611715|P1|Participant Flow|First Line/Hormone-therapy Naive|Patients who have not received hormonal therapy
1081251|NCT00611715|O2|Outcome|Second-line/Prev Hormone-therapy tx|Patients that had either received one line of endocrine therapy in the metastatic setting or recurred less than 12 months after completion of endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
1081252|NCT00611715|O1|Outcome|First Line/Hormone-therapy Naive|Patients that were endocrine treatment-naïve in the metastatic setting and more than 12 months from adjuvant endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
1081253|NCT00611715|O2|Outcome|Second-line/Prev Hormone-therapy tx|Patients that had either received one line of endocrine therapy in the metastatic setting or recurred less than 12 months after completion of endocrine therapy
1081254|NCT00611715|O1|Outcome|First Line/Hormone-therapy Naive|Patients that were endocrine treatment-naive in the metastatic setting and more than 12 months from adjuvant endocrine therapy
1081255|NCT00611715|O2|Outcome|Second-line/Prev Hormone-therapy tx|Patients who had either received one line of endocrine therapy in the metastatic setting or recurred less than 12 months after completion of endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
1081256|NCT00611715|O1|Outcome|First Line/Hormone-therapy Naive|Patients who were endocrine treatment-naïve in the metastatic setting and more than 12 months from adjuvant endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
1081257|NCT00611715|O2|Outcome|Previous Hormone Therapy|Patients who had either received one line of endocrine therapy in the metastatic setting or recurred less than 12 months after completion of endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
1081258|NCT00611715|O1|Outcome|Hormone Therapy Naive|Patients who were endocrine treatment-naïve in the metastatic setting and more than 12 months from adjuvant endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
1081259|NCT00611715|E2|Reported Event|Second-line/Prev Hormone-therapy tx|Patients who have previously received hormonal therapy
1081260|NCT00611715|E1|Reported Event|First Line/Hormone-therapy Naive|Patients who have not received hormonal therapy
1081261|NCT00611624|B1|Baseline|Five Days of Mammosite Therapy|
1081262|NCT00611624|P1|Participant Flow|Five Days of Mammosite Therapy|Five Days of Mammosite Therapy (Radiotherapy)
1081263|NCT00611624|O1|Outcome|Patient Characteristics|Twenty-eight women in total were enrolled and had been treated on this trial at the time of analysis (12 additional patients accrued after the initial phase of 16 patients).
1081264|NCT00611624|O1|Outcome|Five Days of Mammosite Therapy|
1081265|NCT00611624|E1|Reported Event|Five Days of Mammosite Therapy|
1081266|NCT00611559|B4|Baseline|Total|Total of all reporting groups
1081267|NCT00611559|B3|Baseline|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
1081268|NCT00611559|B2|Baseline|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
1081269|NCT00611559|B1|Baseline|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
1081270|NCT00611559|P3|Participant Flow|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
1081271|NCT00611559|P2|Participant Flow|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
1081272|NCT00611559|P1|Participant Flow|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
1081273|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
1081274|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
1081275|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
1081276|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
1081277|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
1081278|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
1081279|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
1081280|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
1085003|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
1081281|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
1081282|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
1081283|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
1081284|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
1081285|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
1081286|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
1081287|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
1081288|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
1081289|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
1081290|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
1081291|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
1081292|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
1081293|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
1081294|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
1081295|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
1081296|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
1081297|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
1081298|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
1081299|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
1081300|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
1081301|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
1081302|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
1081303|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
1081304|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
1081305|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
1081306|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
1081307|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
1081308|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
1081309|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
1081310|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
1081311|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
1081312|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
1081313|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
1081314|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
1081315|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
1081316|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
1081317|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
1081318|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
1081319|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
1081320|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
1081321|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
1081322|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
1081323|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
1081324|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
1081325|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
1081326|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
1081327|NCT00611559|E3|Reported Event|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
1081328|NCT00611559|E2|Reported Event|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
1081329|NCT00611559|E1|Reported Event|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
1081330|NCT00611533|B1|Baseline|All Study Participants|Subjects were enrolled into a double-blind, placebo-controlled cross over study where they will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks or placebo (PBO) for 6 weeks, followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week. Subjects will be instructed to take one capsule of ATX 40mg/d or placebo per day. If tolerated, the number of pills of ATX will be increased to 2 per day at the end of Week 1 of both Trials A and B. Subjects will remain on two capsules per day for the remaining 5 weeks of Trials A and B.
1081331|NCT00611533|P2|Participant Flow|Placebo Then Atomoxetine|Subjects were enrolled into a double-blind, placebo-controlled cross over study where they will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks or placebo (PBO) for 6 weeks, followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week. Subjects will be instructed to take one capsule of ATX 40mg/d or placebo per day. If tolerated, the number of pills of ATX will be increased to 2 per day at the end of Week 1 of both Trials A and B. Subjects will remain on two capsules per day for the remaining 5 weeks of Trials A and B.
1081332|NCT00611533|P1|Participant Flow|Atomoxetine Then Placebo|Subjects were enrolled into a double-blind, placebo-controlled cross over study where they will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks or placebo (PBO) for 6 weeks, followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week. Subjects will be instructed to take one capsule of ATX 40mg/d or placebo per day. If tolerated, the number of pills of ATX will be increased to 2 per day at the end of Week 1 of both Trials A and B. Subjects will remain on two capsules per day for the remaining 5 weeks of Trials A and B.
1081333|NCT00611533|O3|Outcome|Placebo|Placebo: Subjects will receive placebo equivalent for 6 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
1081334|NCT00611533|O2|Outcome|Atomoxetine|Atomoxetine: Subjects will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
1081335|NCT00611533|O1|Outcome|Baseline|
1081336|NCT00611533|O3|Outcome|Placebo|Placebo: Subjects will receive placebo equivalent for 6 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
1081337|NCT00611533|O2|Outcome|Atomoxetine|Atomoxetine: Subjects will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
1081338|NCT00611533|O1|Outcome|Baseline|
1081339|NCT00611533|O3|Outcome|Placebo|Placebo: Subjects will receive placebo equivalent for 6 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
1081340|NCT00611533|O2|Outcome|Atomoxetine|Atomoxetine: Subjects will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
1081341|NCT00611533|O1|Outcome|Baseline|
1081342|NCT00611533|O3|Outcome|Placebo|Placebo: Subjects will receive placebo equivalent for 6 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
1081343|NCT00611533|O2|Outcome|Atomoxetine|Atomoxetine: Subjects will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
1081344|NCT00611533|O1|Outcome|Baseline|
1081345|NCT00611533|O3|Outcome|Placebo|Placebo: Subjects will receive placebo equivalent for 6 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
1081346|NCT00611533|O2|Outcome|Atomoxetine|Atomoxetine: Subjects will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
1081347|NCT00611533|O1|Outcome|Baseline|
1081348|NCT00611533|E2|Reported Event|Placebo|Placebo: Subjects will receive placebo equivalent for 6 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
1081706|NCT00610675|O1|Outcome|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
1081500|NCT00611442|O2|Outcome|Placebo|split-dose PEG solution without dietary restrictions plus placebo pretreatment
1081349|NCT00611533|E1|Reported Event|Atomoxetine|Atomoxetine: Subjects will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
1081350|NCT00611468|B1|Baseline|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
1081351|NCT00611468|P4|Participant Flow|PK Group for Additional PK Data|Additional patients were enrolled for enhanced PK parameter estimation
1081352|NCT00611468|P3|Participant Flow|Dosage Level 3 for MTD Determination|Dosage level 3 was topotecan 1.25 mg/m2 and erlotinib 150 mg.
1081353|NCT00611468|P2|Participant Flow|Dosage Level 2 for MTD Determination|Dosage level 2 was topotecan 1.0 mg/m2 and erlotinib 150 mg.
1081354|NCT00611468|P1|Participant Flow|Dosage Level 1 for MTD Determination|Dosage level 1 was topotecan 0.75 mg/m2 and erlotinib 150 mg.
1081355|NCT00611468|O1|Outcome|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
1081356|NCT00611468|O1|Outcome|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
1081357|NCT00611468|O1|Outcome|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
1081358|NCT00611468|O1|Outcome|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
1081359|NCT00611468|O1|Outcome|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
1081360|NCT00611468|O1|Outcome|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
1081361|NCT00611468|O1|Outcome|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
1081362|NCT00611468|E1|Reported Event|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
1081363|NCT00611455|B3|Baseline|Total|Total of all reporting groups
1081364|NCT00611455|B2|Baseline|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081365|NCT00611455|B1|Baseline|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081366|NCT00611455|P3|Participant Flow|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
1081367|NCT00611455|P2|Participant Flow|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
1085004|NCT00603525|O1|Outcome|Placebo|
1081368|NCT00611455|P1|Participant Flow|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
1081369|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
1081370|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
1081371|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
1081372|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
1081373|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
1081374|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
1081375|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
1081376|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
1081377|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
1081378|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
1081379|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
1081380|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
1081381|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
1081382|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
1081495|NCT00611442|B1|Baseline|Amitiza|split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
1081383|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
1081384|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
1081385|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
1081386|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
1081387|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
1081388|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
1081389|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
1081390|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
1081391|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
1081392|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
1081393|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
1081394|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
1081395|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
1081396|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
1081397|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
1081496|NCT00611442|P2|Participant Flow|Placebo|split-dose PEG solution without dietary restrictions plus placebo pretreatment
1085005|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
1081398|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
1081399|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
1081400|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
1081401|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
1081402|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
1081403|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
1081404|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
1081405|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
1081406|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
1081407|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
1081408|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
1081409|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
1081410|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
1081411|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
1081412|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
1081497|NCT00611442|P1|Participant Flow|Amitiza|split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
1081413|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
1081414|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
1081415|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
1081416|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
1081417|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
1081418|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
1081419|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
1081420|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
1081421|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
1081422|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
1081423|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
1081424|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
1081425|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
1081426|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
1081427|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
1081498|NCT00611442|O2|Outcome|Placebo|split-dose PEG solution without dietary restrictions plus placebo pretreatment
1085006|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
1081428|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
1081429|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
1081430|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
1081431|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
1081432|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
1081433|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
1081434|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
1081435|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
1081436|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
1081437|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
1081438|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081439|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081440|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081441|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081442|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081443|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081444|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081445|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081446|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081499|NCT00611442|O1|Outcome|Amitiza|split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
1081447|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081448|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081449|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081450|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081451|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081452|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081453|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081454|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081455|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081456|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081457|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081458|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081459|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081460|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081461|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081462|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081463|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081464|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081465|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081466|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081467|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081468|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081469|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081470|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081471|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1083099|NCT00607672|O1|Outcome|Placebo|Patients are randomized to placebo prior to surgery
1081472|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081473|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081474|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081475|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081476|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081477|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081478|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081479|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081480|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081481|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081482|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081483|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081484|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081485|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081486|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081487|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081488|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081489|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1081490|NCT00611455|E3|Reported Event|Placebo or Ofatumumab 700 mg: Follow-up Period|SAEs and non-serious AEs are reported for participants receiving either placebo or ofatumumab 700 mg in the Follow-up Period. Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
1081491|NCT00611455|E2|Reported Event|Ofatumumab 700 mg: DB and OL Periods|SAEs and non-serious AEs are reported for participants receiving ofatumumab 700 mg in either the DB or OL Period. Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
1081492|NCT00611455|E1|Reported Event|Placebo: DB Period|Serious adverse events (SAEs) and non-serious AEs are reported for participants receiving placebo in the DB Period. Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
1081493|NCT00611442|B3|Baseline|Total|Total of all reporting groups
1081494|NCT00611442|B2|Baseline|Placebo|split-dose PEG solution without dietary restrictions plus placebo pretreatment
1083102|NCT00607672|O1|Outcome|Placebo|Patients are randomized to placebo prior to surgery
1081501|NCT00611442|O1|Outcome|Amitiza|split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
1081502|NCT00611442|O2|Outcome|Placebo|split-dose PEG solution without dietary restrictions plus placebo pretreatment
1081503|NCT00611442|O1|Outcome|Amitiza|split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
1081504|NCT00611442|O2|Outcome|Placebo|split-dose PEG solution without dietary restrictions plus placebo pretreatment
1081505|NCT00611442|O1|Outcome|Amitiza|split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
1081506|NCT00611442|E2|Reported Event|Placebo|split-dose PEG solution without dietary restrictions plus placebo pretreatment
1081507|NCT00611442|E1|Reported Event|Amitiza|split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
1081508|NCT00611403|B3|Baseline|Total|Total of all reporting groups
1081509|NCT00611403|B2|Baseline|REFRESH ENDURA®|Artificial Tears (REFRESH ENDURA®)
1081510|NCT00611403|B1|Baseline|RESTASIS®|Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
1081511|NCT00611403|P2|Participant Flow|REFRESH ENDURA®|Artificial Tears (REFRESH ENDURA®)
1081512|NCT00611403|P1|Participant Flow|RESTASIS®|Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
1081513|NCT00611403|O2|Outcome|REFRESH ENDURA®|Artificial Tears (REFRESH ENDURA®)
1081514|NCT00611403|O1|Outcome|RESTASIS®|Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
1081515|NCT00611403|O2|Outcome|REFRESH ENDURA®|Artificial Tears (REFRESH ENDURA®)
1081516|NCT00611403|O1|Outcome|RESTASIS®|Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
1081517|NCT00611403|O2|Outcome|REFRESH ENDURA®|Artificial Tears (REFRESH ENDURA®)
1081518|NCT00611403|O1|Outcome|RESTASIS®|Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
1081519|NCT00611403|E2|Reported Event|REFRESH ENDURA®|Artificial Tears (REFRESH ENDURA®)
1081520|NCT00611403|E1|Reported Event|RESTASIS®|Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
1081521|NCT00611325|B3|Baseline|Total|Total of all reporting groups
1081522|NCT00611325|B2|Baseline|Non-EIAED|Patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 1.7 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
1081523|NCT00611325|B1|Baseline|EIAED|Patients taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 2.5 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
1081524|NCT00611325|P2|Participant Flow|Non-EIAED|Patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 1.7 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
1081525|NCT00611325|P1|Participant Flow|EIAED|Patients taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 2.5 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
1081526|NCT00611325|O2|Outcome|Non-EIAED|Patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 1.7 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
1081527|NCT00611325|O1|Outcome|EIAED|Patients taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 2.5 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
1081528|NCT00611325|O2|Outcome|Non-EIAED|Patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 1.7 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
1081529|NCT00611325|O1|Outcome|EIAED|Patients taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 2.5 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
1081530|NCT00611325|O2|Outcome|Non-EIAED|Patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 1.7 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
1081531|NCT00611325|O1|Outcome|EIAED|Patients taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 2.5 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
1081532|NCT00611325|O2|Outcome|Non-EIAED|Patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 1.7 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
1081533|NCT00611325|O1|Outcome|EIAED|Patients taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 2.5 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
1081534|NCT00611325|O2|Outcome|Non-EIAED|Patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 1.7 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
1081535|NCT00611325|O1|Outcome|EIAED|Patients taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 2.5 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
1081536|NCT00611325|E2|Reported Event|Non-EIAED|"Avastin: Avastin was administered intravenously at the dose 15 mg/kg every 3 weeks.~Bortezomib: Bortezomib was administered on days 1, 4, 8, 11, 22, 25, 29, & 32 of a 42-day cycle. Bortezomib was 1.7 mg/m2 for patients not taking EIAEDs."
1081618|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
1085007|NCT00603525|O1|Outcome|Placebo|
1082586|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1081537|NCT00611325|E1|Reported Event|EIAED|"Avastin: Avastin was administered intravenously at the dose 15 mg/kg every 3 weeks.~Bortezomib: Bortezomib was administered on days 1, 4, 8, 11, 22, 25, 29, & 32 of a 42-day cycle. Bortezomib was 2.5 mg/m2 for patients taking EIAEDs."
1081538|NCT00611247|B3|Baseline|Total|Total of all reporting groups
1081539|NCT00611247|B2|Baseline|Un-Methylated AGAT Promoter (Group 2)|Priming: 100 mg/m2/day oral Temozolomide x 14 days, followed by Induction: 200 mg/m2/day oral Temozolomide x 7 days
1081540|NCT00611247|B1|Baseline|Methylated AGAT Promoter (Group 1)|Induction: 200 mg/m2/day oral Temozolomide x 7 days
1081541|NCT00611247|P2|Participant Flow|Un-Methylated AGAT Promoter (Group 2)|Priming: 100 mg/m2/day oral Temozolomide x 14 days, followed by Induction: 200 mg/m2/day oral Temozolomide x 7 days
1081542|NCT00611247|P1|Participant Flow|Methylated AGAT Promoter (Group 1)|Induction: 200 mg/m2/day oral Temozolomide x 7 days
1081543|NCT00611247|O2|Outcome|Un-Methylated AGAT Promoter (Group 2)|Priming: 100 mg/m2/day oral Temozolomide x 14 days, then followed by Induction: 200 mg/m2/day oral Temozolomide x 7 days
1081544|NCT00611247|O1|Outcome|Methylated AGAT Promoter (Group 1)|Induction: 200 mg/m2/day oral Temozolomide x 7 days
1081545|NCT00611247|O2|Outcome|Un-Methylated AGAT Promoter (Group 2)|Priming: 100 mg/m2/day oral Temozolomide x 14 days, then followed by Induction: 200 mg/m2/day oral Temozolomide x 7 days
1081546|NCT00611247|O1|Outcome|Methylated AGAT Promoter (Group 1)|Induction: 200 mg/m2/day oral Temozolomide x 7 days
1081547|NCT00611247|O2|Outcome|Un-Methylated AGAT Promoter (Group 2)|Priming: 100 mg/m2/day oral Temozolomide x 14 days, followed by Induction: 200 mg/m2/day oral Temozolomide x 7 days
1081548|NCT00611247|O1|Outcome|Methylated AGAT Promoter (Group 1)|Induction: 200 mg/m2/day oral Temozolomide x 7 days
1081549|NCT00611247|E2|Reported Event|Un-Methylated AGAT Promoter (Group 2)|Priming: 100 mg/m2/day oral Temozolomide x 14 days, then followed by Induction: 200 mg/m2/day oral Temozolomide x 7 days
1081550|NCT00611247|E1|Reported Event|Methylated AGAT Promoter (Group 1)|Induction: 200 mg/m2/day oral Temozolomide x 7 days
1081551|NCT00611130|B3|Baseline|Total|Total of all reporting groups
1081552|NCT00611130|B2|Baseline|Placebo|Matching Placebo Tablets. 3 tablets bid.
1081553|NCT00611130|B1|Baseline|CPP-109 Vigabatrin|CPP-109 tablets, 500 mg. 3 Tablets bid.
1081554|NCT00611130|P2|Participant Flow|Placebo|Matching Placebo Tablets. 3 tablets bid.
1081555|NCT00611130|P1|Participant Flow|CPP-109 Vigabatrin|CPP-109 tablets, 500 mg. 3 Tablets bid.
1081556|NCT00611130|O1|Outcome|Treatment Phase Completers|Up to 12 urine specimens out of 37 collected during the Treatment Phase completers were analyzed for vigabatrin levels.
1081557|NCT00611130|O2|Outcome|Matching Placebo Tablets|Subjects proceeded to a 12 week Treatment Phase,receiving 3 tablets bid po Finally, subjects then proceeded to a 12 week follow-up period. Subjects attended clinic visits 3 times per week (typically on Monday, Wednesday, and Friday) during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects returned for follow up visits at Weeks 13, 16, 20 and 24.
1081558|NCT00611130|O1|Outcome|CPP-109 Vigabatrin Tablets, 500 mg|Vigabatrin Tablets, 1.5 g bid po, 12 weeks, computerized cognitive behavioral therapy plus contingency management.Subjects proceeded to a 12 week Treatment Phase, including a 2 week dose escalation period, a 9 week maintenance period (3.0 gm/day of vigabatrin) and a 1 week medication taper period. Finally, subjects then proceeded to a 12 week follow-up period. Subjects attended clinic visits 3 times per week (typically on Monday, Wednesday, and Friday) for efficacy and safety assessments and for treatment during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects returned for follow up visits at Weeks 13, 16, 20 and 24.
1081559|NCT00611130|E2|Reported Event|Matching Placebo Tablet|Subjects proceeded to a 12 week Treatment Phase,receiving 3 tablets bid po Finally, subjects then proceeded to a 12 week follow-up period. Subjects were scheduled for clinic visits 3 times per week (typically on Monday, Wednesday, and Friday) during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects returned for follow up visits at Weeks 13, 16, 20 and 24.
1081560|NCT00611130|E1|Reported Event|CPP-109 Vigabatrin Tablets, 500 mg|Vigabatrin Tablets, 1.5 g bid po, 12 weeks. Subjects proceeded to a 12 week Treatment Phase, including a 2 week dose escalation period, a 9 week maintenance period (3.0 gm/day of vigabatrin), and a 1 week medication taper period. Finally, subjects then proceeded to a 12 week follow-up period. Subjects were scheduled for clinic visits 3 times per week (typically on Monday, Wednesday, and Friday) during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects returned for follow up visits at Weeks 13, 16, 20 and 24.
1081561|NCT00611026|B4|Baseline|Total|Total of all reporting groups
1081562|NCT00611026|B3|Baseline|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
1081563|NCT00611026|B2|Baseline|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
1081564|NCT00611026|B1|Baseline|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
1081565|NCT00611026|P3|Participant Flow|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
1081566|NCT00611026|P2|Participant Flow|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
1081567|NCT00611026|P1|Participant Flow|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
1081568|NCT00611026|O2|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
1081569|NCT00611026|O1|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
1081570|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
1081571|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
1081572|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
1081573|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
1081574|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
1081575|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
1081576|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
1081577|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
1081578|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
1081579|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
1081580|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
1081581|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
1081582|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
1081583|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
1081584|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
1081585|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
1081586|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
1081587|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
1081588|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
1081589|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
1081590|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
1081591|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
1081592|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
1081593|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
1081594|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
1081595|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
1081596|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
1081597|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
1081598|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
1081599|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
1081600|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
1081601|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
1081602|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
1081603|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
1081604|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
1081605|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
1081606|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
1081607|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
1081608|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
1081609|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
1081610|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
1081611|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
1081612|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
1081613|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
1081614|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
1081615|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
1081616|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
1081617|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
1081619|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
1081620|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
1081621|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
1081622|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
1081623|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
1081624|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
1081625|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
1081626|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
1081627|NCT00611026|E3|Reported Event|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
1081628|NCT00611026|E2|Reported Event|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
1081629|NCT00611026|E1|Reported Event|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
1081630|NCT00610987|B3|Baseline|Total|Total of all reporting groups
1081631|NCT00610987|B2|Baseline|Placebo|"Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo, after the intraoperative dose(s) of cefazolin~Placebo: Patients will be randomly assigned to one of two groups. Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo."
1081632|NCT00610987|B1|Baseline|Cefazolin|"Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours after surgical repair of the closed limb fracture.~cefazolin: Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours."
1081633|NCT00610987|P2|Participant Flow|Placebo|"Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo, after the intraoperative dose(s) of cefazolin~Placebo: Patients will be randomly assigned to one of two groups. Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo."
1081634|NCT00610987|P1|Participant Flow|Cefazolin|"Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours after surgical repair of the closed limb fracture.~cefazolin: Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours."
1081635|NCT00610987|O2|Outcome|Placebo|"Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo, after the intraoperative dose(s) of cefazolin~Placebo: Patients will be randomly assigned to one of two groups. Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo."
1081636|NCT00610987|O1|Outcome|Cefazolin|"Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours after surgical repair of the closed limb fracture.~cefazolin: Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours."
1081637|NCT00610987|E2|Reported Event|Placebo|"Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo, after the intraoperative dose(s) of cefazolin~Placebo: Patients will be randomly assigned to one of two groups. Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo."
1081638|NCT00610987|E1|Reported Event|Cefazolin|"Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours after surgical repair of the closed limb fracture.~cefazolin: Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours."
1085008|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
1081639|NCT00610883|B1|Baseline|All Patients|LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU: LSA4 intervention includes three phases: induction, consolidation and maintenance
1081640|NCT00610883|P1|Participant Flow|All Patients|LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU: LSA4 intervention includes three phases: induction, consolidation and maintenance
1081641|NCT00610883|O1|Outcome|All Patients|LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU: LSA4 intervention includes three phases: induction, consolidation and maintenance
1081642|NCT00610883|E1|Reported Event|All Patients|LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU: LSA4 intervention includes three phases: induction, consolidation and maintenance
1081650|NCT00610740|B1|Baseline|Patients Treated With CerviPrep™|During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. CerviPrep™, a novel drug delivery device, was developed specifically for applying pharmaceuticals directly on the cervix. It consists of a syringe-like tube attached to a plastic cap that covers the cervix. Drug can be delivered through the tube, directly to the cervix without spillage onto vaginal or vulvar tissues.
1081651|NCT00610740|P1|Participant Flow|Patients Treated With CerviPrep™|During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. CerviPrep™, a novel drug delivery device, was developed specifically for applying pharmaceuticals directly on the cervix. It consists of a syringe-like tube attached to a plastic cap that covers the cervix. Drug can be delivered through the tube, directly to the cervix without spillage onto vaginal or vulvar tissues.
1081652|NCT00610740|O1|Outcome|Patients Treated With CerviPrep™|During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. CerviPrep™, a novel drug delivery device, was developed specifically for applying pharmaceuticals directly on the cervix. It consists of a syringe-like tube attached to a plastic cap that covers the cervix. Drug can be delivered through the tube, directly to the cervix without spillage onto vaginal or vulvar tissues.
1081653|NCT00610740|O1|Outcome|Patients Treated With CerviPrep™|During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. CerviPrep™, a novel drug delivery device, was developed specifically for applying pharmaceuticals directly on the cervix. It consists of a syringe-like tube attached to a plastic cap that covers the cervix. Drug can be delivered through the tube, directly to the cervix without spillage onto vaginal or vulvar tissues.
1081654|NCT00610740|O1|Outcome|Patients Treated With CerviPrep™|During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. CerviPrep™, a novel drug delivery device, was developed specifically for applying pharmaceuticals directly on the cervix. It consists of a syringe-like tube attached to a plastic cap that covers the cervix. Drug can be delivered through the tube, directly to the cervix without spillage onto vaginal or vulvar tissues.
1081655|NCT00610740|E1|Reported Event|Patients Treated With CerviPrep™|During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. CerviPrep™, a novel drug delivery device, was developed specifically for applying pharmaceuticals directly on the cervix. It consists of a syringe-like tube attached to a plastic cap that covers the cervix. Drug can be delivered through the tube, directly to the cervix without spillage onto vaginal or vulvar tissues.
1081656|NCT00610714|B3|Baseline|Total|Total of all reporting groups
1081657|NCT00610714|B2|Baseline|Carboplatin ,Paclitaxel|Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
1081658|NCT00610714|B1|Baseline|AZD0530 , Paclitaxel , Carboplatin i.v.|AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
1081659|NCT00610714|P2|Participant Flow|Carboplatin ,Paclitaxel|Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
1081660|NCT00610714|P1|Participant Flow|AZD0530 , Paclitaxel , Carboplatin i.v.|AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
1081661|NCT00610714|O2|Outcome|Carboplatin ,Paclitaxel|Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
1081702|NCT00610675|O1|Outcome|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
1081703|NCT00610675|O1|Outcome|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
1081704|NCT00610675|O1|Outcome|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
1081662|NCT00610714|O1|Outcome|AZD0530 , Paclitaxel , Carboplatin i.v.|AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
1081663|NCT00610714|O2|Outcome|Carboplatin ,Paclitaxel|Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
1081664|NCT00610714|O1|Outcome|AZD0530 , Paclitaxel , Carboplatin i.v.|AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
1081665|NCT00610714|O2|Outcome|Carboplatin ,Paclitaxel|Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
1081714|NCT00610649|B6|Baseline|Part 1: Block C Placebo|Participants receive placebo BID for a total of 10 days.
1081715|NCT00610649|B5|Baseline|Part 1: Block C MK-8777|Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
1081666|NCT00610714|O1|Outcome|AZD0530 , Paclitaxel , Carboplatin i.v.|AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
1081667|NCT00610714|E2|Reported Event|Carboplatin ,Paclitaxel|Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
1081668|NCT00610714|E1|Reported Event|AZD0530 , Paclitaxel , Carboplatin i.v.|AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
1081669|NCT00610701|B3|Baseline|Total|Total of all reporting groups
1081670|NCT00610701|B2|Baseline|2-lateral Pin Placement|"Lateral~Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind"
1081671|NCT00610701|B1|Baseline|1-anterior Pin Placement|"Anterior~Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins"
1081672|NCT00610701|P2|Participant Flow|2 Lateral|"Lateral~Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind"
1081673|NCT00610701|P1|Participant Flow|1 Anterior|"Anterior~Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins"
1081674|NCT00610701|O2|Outcome|2-lateral Pin Placement|"Lateral~Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind"
1081675|NCT00610701|O1|Outcome|1-anterior Pin Placement|"Anterior~Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins"
1081676|NCT00610701|E2|Reported Event|2 Lateral|"Lateral~Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind"
1081677|NCT00610701|E1|Reported Event|1 Anterior|"Anterior~Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins"
1081678|NCT00610688|B4|Baseline|Total|Total of all reporting groups
1081679|NCT00610688|B3|Baseline|4000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
1081680|NCT00610688|B2|Baseline|2000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
1081681|NCT00610688|B1|Baseline|400 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
1081682|NCT00610688|P3|Participant Flow|4000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
1081683|NCT00610688|P2|Participant Flow|2000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
1081684|NCT00610688|P1|Participant Flow|400 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
1081685|NCT00610688|O3|Outcome|4000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
1081686|NCT00610688|O2|Outcome|2000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
1081687|NCT00610688|O1|Outcome|400 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
1081688|NCT00610688|O3|Outcome|4000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
1081689|NCT00610688|O2|Outcome|2000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
1081690|NCT00610688|O1|Outcome|400 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
1081691|NCT00610688|O3|Outcome|4000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
1081692|NCT00610688|O2|Outcome|2000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
1081693|NCT00610688|O1|Outcome|400 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
1081694|NCT00610688|E3|Reported Event|4000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
1081695|NCT00610688|E2|Reported Event|2000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
1081696|NCT00610688|E1|Reported Event|400 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
1081697|NCT00610675|B1|Baseline|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
1081698|NCT00610675|P1|Participant Flow|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
1081699|NCT00610675|O1|Outcome|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
1081700|NCT00610675|O1|Outcome|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
1081701|NCT00610675|O1|Outcome|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
1081707|NCT00610675|E1|Reported Event|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
1081708|NCT00610649|B12|Baseline|Total|Total of all reporting groups
1081709|NCT00610649|B11|Baseline|Part 2: Placebo|Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
1081710|NCT00610649|B10|Baseline|Part 2: MK-8777 800 mg|Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.
1081711|NCT00610649|B9|Baseline|Part 2: MK-8777 200 mg|Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days.
1081712|NCT00610649|B8|Baseline|Part 1: Block D Placebo|Participants receive placebo BID for a total of 13 days.
1081713|NCT00610649|B7|Baseline|Part 1: Block D MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
1081716|NCT00610649|B4|Baseline|Part 1: Block B Placebo|Participants receive placebo BID for a total of 13 days.
1081717|NCT00610649|B3|Baseline|Part 1: Block B MK-8777|Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
1081718|NCT00610649|B2|Baseline|Part 1: Block A Placebo|Participants receive placebo BID for a total of 16 days.
1081719|NCT00610649|B1|Baseline|Part 1: Block A MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
1081720|NCT00610649|P11|Participant Flow|Part 2: Placebo|Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
1081721|NCT00610649|P10|Participant Flow|Part 2: MK-8777 800 mg|Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.
1081722|NCT00610649|P9|Participant Flow|Part 2: MK-8777 200 mg|Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg once daily (QD). Participants receive MK-8777 for a total of 28 days.
1081723|NCT00610649|P8|Participant Flow|Part 1: Block D Placebo|Participants receive placebo BID for a total of 13 days.
1081724|NCT00610649|P7|Participant Flow|Part 1: Block D MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
1081725|NCT00610649|P6|Participant Flow|Part 1: Block C Placebo|Participants receive placebo BID for a total of 10 days.
1081726|NCT00610649|P5|Participant Flow|Part 1: Block C MK-8777|Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
1081727|NCT00610649|P4|Participant Flow|Part 1: Block B Placebo|Participants receive placebo BID for a total of 13 days.
1081728|NCT00610649|P3|Participant Flow|Part 1: Block B MK-8777|Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
1081729|NCT00610649|P2|Participant Flow|Part 1: Block A Placebo|Participants receive placebo BID for a total of 16 days.
1081730|NCT00610649|P1|Participant Flow|Part 1: Block A MK-8777|Participants receive MK-8777 initiated at 100 mg twice daily (BID) and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
1081731|NCT00610649|O3|Outcome|Part 2: Placebo|Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
1081732|NCT00610649|O2|Outcome|Part 2: MK-8777 800 mg|Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.
1081733|NCT00610649|O1|Outcome|Part 2: MK-8777 200 mg|Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days.
1081734|NCT00610649|O8|Outcome|Part 1: Block D Placebo|Participants receive placebo BID for a total of 13 days.
1081735|NCT00610649|O7|Outcome|Part 1: Block D MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
1081736|NCT00610649|O6|Outcome|Part 1: Block C Placebo|Participants receive placebo BID for a total of 10 days.
1081737|NCT00610649|O5|Outcome|Part 1: Block C MK-8777|Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
1081738|NCT00610649|O4|Outcome|Part 1: Block B Placebo|Participants receive placebo BID for a total of 13 days.
1081739|NCT00610649|O3|Outcome|Part 1: Block B MK-8777|Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
1081740|NCT00610649|O2|Outcome|Part 1: Block A Placebo|Participants receive placebo BID for a total of 16 days.
1081741|NCT00610649|O1|Outcome|Part 1: Block A MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
1081742|NCT00610649|O3|Outcome|Part 2: Placebo|Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
1081743|NCT00610649|O2|Outcome|Part 2: MK-8777 800 mg|Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.
1081744|NCT00610649|O1|Outcome|Part 2: MK-8777 200 mg|Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days.
1081745|NCT00610649|O3|Outcome|Part 2: Placebo|Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
1081746|NCT00610649|O2|Outcome|Part 2: MK-8777 800 mg|Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.
1081747|NCT00610649|O1|Outcome|Part 2: MK-8777 200 mg|Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days.
1081748|NCT00610649|O8|Outcome|Part 1: Block D Placebo|Participants receive placebo BID for a total of 13 days.
1081749|NCT00610649|O7|Outcome|Part 1: Block D MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
1081750|NCT00610649|O6|Outcome|Part 1: Block C Placebo|Participants receive placebo BID for a total of 10 days.
1081751|NCT00610649|O5|Outcome|Part 1: Block C MK-8777|Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
1081752|NCT00610649|O4|Outcome|Part 1: Block B Placebo|Participants receive placebo BID for a total of 13 days.
1081753|NCT00610649|O3|Outcome|Part 1: Block B MK-8777|Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
1081754|NCT00610649|O2|Outcome|Part 1: Block A Placebo|Participants receive placebo BID for a total of 16 days.
1081832|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
1081755|NCT00610649|O1|Outcome|Part 1: Block A MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
1081756|NCT00610649|O8|Outcome|Part 1: Block D Placebo|Participants receive placebo BID for a total of 13 days.
1081757|NCT00610649|O7|Outcome|Part 1: Block D MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
1081758|NCT00610649|O6|Outcome|Part 1: Block C Placebo|Participants receive placebo BID for a total of 10 days.
1081759|NCT00610649|O5|Outcome|Part 1: Block C MK-8777|Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
1081760|NCT00610649|O4|Outcome|Part 1: Block B Placebo|Participants receive placebo BID for a total of 13 days.
1081761|NCT00610649|O3|Outcome|Part 1: Block B MK-8777|Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
1081762|NCT00610649|O2|Outcome|Part 1: Block A Placebo|Participants receive placebo BID for a total of 16 days.
1081763|NCT00610649|O1|Outcome|Part 1: Block A MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
1081764|NCT00610649|O8|Outcome|Part 1: Block D Placebo|Participants receive placebo BID for a total of 13 days.
1081765|NCT00610649|O7|Outcome|Part 1: Block D MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
1081766|NCT00610649|O6|Outcome|Part 1: Block C Placebo|Participants receive placebo BID for a total of 10 days.
1081767|NCT00610649|O5|Outcome|Part 1: Block C MK-8777|Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
1081768|NCT00610649|O4|Outcome|Part 1: Block B Placebo|Participants receive placebo BID for a total of 13 days.
1081769|NCT00610649|O3|Outcome|Part 1: Block B MK-8777|Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
1081770|NCT00610649|O2|Outcome|Part 1: Block A Placebo|Participants receive placebo BID for a total of 16 days.
1081771|NCT00610649|O1|Outcome|Part 1: Block A MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
1081772|NCT00610649|E11|Reported Event|Part 2: Placebo|Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
1081773|NCT00610649|E10|Reported Event|Part 2: MK-8777 800 mg|Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.
1081774|NCT00610649|E9|Reported Event|Part 2: MK-8777 200 mg|Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days.
1081775|NCT00610649|E8|Reported Event|Part 1: Block D Placebo|Participants receive placebo BID for a total of 13 days.
1081776|NCT00610649|E7|Reported Event|Part 1: Block D MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
1081777|NCT00610649|E6|Reported Event|Part 1: Block C Placebo|Participants receive placebo BID for a total of 10 days.
1081778|NCT00610649|E5|Reported Event|Part 1: Block C MK-8777|Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
1081779|NCT00610649|E4|Reported Event|Part 1: Block B Placebo|Participants receive placebo BID for a total of 13 days.
1081780|NCT00610649|E3|Reported Event|Part 1: Block B MK-8777|Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
1081781|NCT00610649|E2|Reported Event|Part 1: Block A Placebo|Participants receive placebo BID for a total of 16 days.
1081782|NCT00610649|E1|Reported Event|Part 1: Block A MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
1081783|NCT00610532|B1|Baseline|All Study Participants|All study participants progressed from intravenous phenytoin alone to intravenous phenytoin plus probenecid
1081784|NCT00610532|P1|Participant Flow|All Study Participants|All study participants progressed from receiving intravenous phenytoin alone to intravenous phenytoin plus probenecid.
1081785|NCT00610532|O2|Outcome|Intravenous Phenytoin Plus Probenecid|intravenous phenytoin plus probenecid
1081786|NCT00610532|O1|Outcome|Intravenous Phenytoin Alone|intravenous phenytoin alone
1081787|NCT00610532|E2|Reported Event|Intravenous Phenytoin Plus Probenecid|intravenous phenytoin plus probenecid
1081788|NCT00610532|E1|Reported Event|Intravenous Phenytoin Alone|intravenous phenytoin alone
1081789|NCT00610441|B5|Baseline|Total|Total of all reporting groups
1081790|NCT00610441|B4|Baseline|PBO→MK-8777 RD|Participants receive rising doses of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 2).
1081791|NCT00610441|B3|Baseline|MK-8777 RD→PBO|Participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of placebo BID for 3 weeks (Treatment Period 2).
1081792|NCT00610441|B2|Baseline|PBO→MK-8777 FD|Participants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of MK-8777 100 mg BID for 3 weeks (Treatment Period 2).
1081793|NCT00610441|B1|Baseline|MK-8777 FD→PBO|Participants receive a fixed dose FD of MK-8777 100 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 2).
1081794|NCT00610441|P4|Participant Flow|PBO→MK-8777 RD|Participants receive rising doses of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 2).
1081795|NCT00610441|P3|Participant Flow|MK-8777 RD→PBO|Participants receive rising doses (RD) of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of placebo BID for 3 weeks (Treatment Period 2).
1081796|NCT00610441|P2|Participant Flow|PBO→MK-8777 FD|Participants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of MK-8777 100 mg BID for 3 weeks (Treatment Period 2).
1081797|NCT00610441|P1|Participant Flow|MK-8777 FD→PBO|Participants receive a fixed dose (FD) of MK-8777 100 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 2).
1081798|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
1081799|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081800|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
1081801|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081802|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
1081803|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081804|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
1081805|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081806|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
1081807|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081808|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
1081809|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081810|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
1081811|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081812|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
1081813|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081814|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
1081815|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081816|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
1081817|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081818|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
1081819|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081820|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
1081821|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081822|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
1081823|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081824|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
1082581|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1081825|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081826|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
1081827|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081828|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
1081829|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081830|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
1081831|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081833|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081834|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
1081835|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081836|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
1081837|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081838|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
1081839|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081840|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
1081841|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081842|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
1081843|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081844|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
1081845|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081846|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
1081847|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081848|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
1081849|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081850|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
1081851|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081852|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
1081853|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081854|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
1081855|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081856|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
1081857|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081858|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
1081859|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081860|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
1081861|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081862|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
1081863|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1082582|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1081864|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
1081865|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081866|NCT00610441|O3|Outcome|MK-8777 100-300mg|Participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks.
1081867|NCT00610441|O2|Outcome|MK-8777 100mg|Participants receive a fixed dose of MK-8777 100 mg BID for 3 weeks.
1081868|NCT00610441|O1|Outcome|Placebo|Participants receive placebo BID for 3 weeks.
1081869|NCT00610441|O3|Outcome|MK-8777 100-300mg|Participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks.
1081870|NCT00610441|O2|Outcome|MK-8777 100mg|Participants receive a fixed dose of MK-8777 100 mg BID for 3 weeks.
1081871|NCT00610441|O1|Outcome|Placebo|Participants receive placebo BID for 3 weeks.
1081872|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
1081873|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081874|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
1081875|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081876|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
1081877|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081878|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
1081879|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081880|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
1081881|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081882|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
1081883|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
1081884|NCT00610441|E3|Reported Event|MK-8777 100-300mg|Participants receive rising doses of MK-8777 100-300 mg BID for up to 3 weeks.
1081885|NCT00610441|E2|Reported Event|MK-8777 100mg|Participants receive a fixed dose of MK-8777 100 mg BID for up to 3 weeks.
1081886|NCT00610441|E1|Reported Event|Placebo|Participants receive placebo BID for up to 5 weeks.
1081887|NCT00610363|B3|Baseline|Total|Total of all reporting groups
1081888|NCT00610363|B2|Baseline|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
1081889|NCT00610363|B1|Baseline|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
1081890|NCT00610363|P2|Participant Flow|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
1081891|NCT00610363|P1|Participant Flow|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 16.
1081892|NCT00610363|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
1081893|NCT00610363|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
1081894|NCT00610363|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
1081895|NCT00610363|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
1081896|NCT00610363|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
1081897|NCT00610363|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
1081898|NCT00610363|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
1081899|NCT00610363|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
1081900|NCT00610363|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
1081901|NCT00610363|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
1081902|NCT00610363|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
1081903|NCT00610363|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
1082646|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1081904|NCT00610363|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
1081905|NCT00610363|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
1081906|NCT00610363|E2|Reported Event|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 16.
1081907|NCT00610363|E1|Reported Event|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 16.
1081921|NCT00610168|B2|Baseline|Boostrix II Group|Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
1081990|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
1081908|NCT00610311|B1|Baseline|ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-2|"ALVAC plus anti-gp100:154-162 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + HD interleukin-2 (IL-2): ALVAC vaccine two hours prior to cell infusion patients will receive 0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6.4 to 107.9/mL of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL. This will be repeated on day 14.~3 x 10^11 anti-gp100:154-162 TCR engineered PBL by intravenous infusion. A minimum of approximately 5 x 10^8 cells will be given.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)– 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)"
1081909|NCT00610311|P1|Participant Flow|ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-2|"ALVAC plus anti-gp100:154-162 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + HD interleukin-2 (IL-2): ALVAC vaccine two hours prior to cell infusion patients will receive 0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6.4 to 107.9/mL of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL. This will be repeated on day 14.~3 x 10^11 anti-gp100:154-162 TCR engineered PBL by intravenous infusion. A minimum of approximately 5 x 10^8 cells will be given.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)– 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)"
1081910|NCT00610311|O1|Outcome|ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-2|"ALVAC plus anti-gp100:154-162 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + HD interleukin-2 (IL-2): ALVAC vaccine two hours prior to cell infusion patients will receive 0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6.4 to 107.9/mL of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL. This will be repeated on day 14.~3 x 10^11 anti-gp100:154-162 TCR engineered PBL by intravenous infusion. A minimum of approximately 5 x 10^8 cells will be given.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)"
1081911|NCT00610311|O1|Outcome|ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-2|"ALVAC plus anti-gp100:154-162 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + HD interleukin-2 (IL-2): ALVAC vaccine two hours prior to cell infusion patients will receive 0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6.4 to 107.9/mL of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL. This will be repeated on day 14.~3 x 10^11 anti-gp100:154-162 TCR engineered PBL by intravenous infusion. A minimum of approximately 5 x 10^8 cells will be given.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)"
1081912|NCT00610311|O1|Outcome|ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-2|"ALVAC plus anti-gp100:154-162 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + HD interleukin-2 (IL-2): ALVAC vaccine two hours prior to cell infusion patients will receive 0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6.4 to 107.9/mL of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL. This will be repeated on day 14.~3 x 10^11 anti-gp100:154-162 TCR engineered PBL by intravenous infusion. A minimum of approximately 5 x 10^8 cells will be given.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)"
1081913|NCT00610311|O1|Outcome|ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-2|"ALVAC plus anti-gp100:154-162 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + HD interleukin-2 (IL-2): ALVAC vaccine two hours prior to cell infusion patients will receive 0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6.4 to 107.9/mL of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL. This will be repeated on day 14.~3 x 10^11 anti-gp100:154-162 TCR engineered PBL by intravenous infusion. A minimum of approximately 5 x 10^8 cells will be given.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)"
1081914|NCT00610311|E1|Reported Event|ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-2|"ALVAC plus anti-gp100:154-162 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + HD interleukin-2 (IL-2): ALVAC vaccine two hours prior to cell infusion patients will receive 0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6.4 to 107.9/mL of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL. This will be repeated on day 14.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)"
1081915|NCT00610207|B1|Baseline|Biodesign® Anal Fistula Plug|"Biodesign is a bioprosthetic material derived from porcine small intestinal submucosa (SIS) that provides mechanical integrity while acting as a scaffold to guide tissue incorporation.~Three single tract fistula patients were lost to follow-up and were excluded from the analysis."
1081916|NCT00610207|P1|Participant Flow|Biodesign® Anal Fistula Plug|"Biodesign is a bioprosthetic material derived from porcine small intestinal submucosa (SIS) that provides mechanical integrity while acting as a scaffold to guide tissue incorporation.~Three single tract fistula patients were lost to follow-up and were excluded from the analysis."
1081917|NCT00610207|O1|Outcome|Biodesign® Anal Fistula Plug|"Biodesign is a bioprosthetic material derived from porcine small intestinal submucosa (SIS) that provides mechanical integrity while acting as a scaffold to guide tissue incorporation.~Three single tract fistula patients were lost to follow-up and were excluded from the analysis."
1081983|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
1081918|NCT00610207|O1|Outcome|Biodesign® Anal Fistula Plug|"Biodesign is a bioprosthetic material derived from porcine small intestinal submucosa (SIS) that provides mechanical integrity while acting as a scaffold to guide tissue incorporation.~Three single tract fistula patients were lost to follow-up and were excluded from the analysis."
1081919|NCT00610207|E1|Reported Event|Biodesign® Anal Fistula Plug|"Biodesign is a bioprosthetic material derived from porcine small intestinal submucosa (SIS) that provides mechanical integrity while acting as a scaffold to guide tissue incorporation.~Three single tract fistula patients were lost to follow-up and were excluded from the analysis."
1081920|NCT00610168|B3|Baseline|Total|Total of all reporting groups
1083107|NCT00607672|O2|Outcome|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
1081922|NCT00610168|B1|Baseline|Boostrix I Group|Subjects, who had received Boostrix™ vaccine in the primary study (263855/004), received one additional booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
1081923|NCT00610168|P2|Participant Flow|Boostrix II Group|Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
1081924|NCT00610168|P1|Participant Flow|Boostrix I Group|Subjects, who had received Boostrix™ vaccine in the primary study (263855/004), received one additional booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
1081925|NCT00610168|O1|Outcome|Boostrix Pooled Group|Boostrix I and Boostrix II Groups pooled together.
1081926|NCT00610168|O1|Outcome|Boostrix Pooled Group|Boostrix I and Boostrix II Groups pooled together.
1081927|NCT00610168|O1|Outcome|Boostrix Pooled Group|Boostrix I and Boostrix II Groups pooled together.
1081928|NCT00610168|O1|Outcome|Boostrix Pooled Group|Boostrix I and Boostrix II Groups pooled together.
1081929|NCT00610168|O2|Outcome|Boostrix II Group|Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
1081930|NCT00610168|O1|Outcome|Boostrix I Group|Subjects, who had received Boostrix™ vaccine in the primary study (263855/004), received one additional booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
1081931|NCT00610168|O2|Outcome|Boostrix II Group|Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
1081932|NCT00610168|O1|Outcome|Boostrix I Group|Subjects, who had received Boostrix™ vaccine in the primary study (263855/004), received one additional booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
1081933|NCT00610168|O2|Outcome|Boostrix II Group|Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
1081934|NCT00610168|O1|Outcome|Boostrix I Group|Subjects, who had received Boostrix™ vaccine in the primary study (263855/004), received one additional booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
1081935|NCT00610168|O2|Outcome|Boostrix II Group|Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
1081936|NCT00610168|O1|Outcome|Boostrix I Group|Subjects, who had received Boostrix™ vaccine in the primary study (263855/004), received one additional booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
1081937|NCT00610168|O2|Outcome|Boostrix II Group|Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
1081938|NCT00610168|O1|Outcome|Boostrix I Group|Subjects, who had received Boostrix™ vaccine in the primary study (263855/004), received one additional booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
1081939|NCT00610168|O2|Outcome|Boostrix II Group|Subjects, who had received Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals’ acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
1081940|NCT00610168|O1|Outcome|Boostrix I Group|Subjects, who had received Boostrix™ vaccine in the primary study (263855/004), received one additional booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
1081941|NCT00610168|E1|Reported Event|Boostrix Pooled Group|Boostrix I and Boostrix II Groups pooled together.
1081942|NCT00610155|B1|Baseline|Entire Study Population|Includes all participants enrolled in the study.
1081943|NCT00610155|P6|Participant Flow|Tramadol Then Pregabalin Then Placebo|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in first intervention period; followed by pregabalin capsule titrated to 150 mg orally twice daily for 7 days in second intervention period; then matching placebo capsule orally for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
1081944|NCT00610155|P5|Participant Flow|Placebo Then Tramadol Then Pregabalin|Matching placebo capsule orally for 7 days in first intervention period; followed by tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in second intervention period; then pregabalin capsule titrated to 150 mg orally twice daily for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
1081945|NCT00610155|P4|Participant Flow|Pregabalin Then Placebo Then Tramadol|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in first intervention period; followed by matching placebo capsule orally for 7 days in second intervention period; then tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
1081989|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
1081991|NCT00610155|E3|Reported Event|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
1081946|NCT00610155|P3|Participant Flow|Placebo Then Pregabalin Then Tramadol|Matching placebo capsule orally for 7 days in first intervention period; followed by pregabalin capsule titrated to 150 mg orally twice daily for 7 days in second intervention period; then tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
1081947|NCT00610155|P2|Participant Flow|Tramadol Then Placebo Then Pregabalin|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in first intervention period; followed by matching placebo capsule orally for 7 days in second intervention period; then pregabalin capsule titrated to 150 mg orally twice daily for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
1081948|NCT00610155|P1|Participant Flow|Pregabalin Then Tramadol Then Placebo|Pregabalin (PGB) capsule titrated to 150 milligram (mg) orally twice daily for 7 days in first intervention period; followed by tramadol (TMD) sustained release (SR) capsule titrated to 200 mg orally twice daily for 7 days in second intervention period; then matching placebo (PBO) capsule orally for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
1081949|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
1081950|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
1081951|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
1081952|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
1081953|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
1081954|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
1081955|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
1081956|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
1081957|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
1081958|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
1081959|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
1081960|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
1081961|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
1081962|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
1081963|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
1081964|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
1081965|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
1081966|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
1081967|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
1081968|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
1081969|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
1081970|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
1081971|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
1081972|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
1081973|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
1081974|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
1081975|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
1081976|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
1081977|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
1081978|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
1081979|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
1081980|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
1081981|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
1081982|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
1082020|NCT00609973|O2|Outcome|Placebo|Placebo bid
1081984|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
1081985|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
1081986|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
1081987|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
1081988|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
1083108|NCT00607672|O1|Outcome|Placebo|Patients are randomized to placebo prior to surgery
1081992|NCT00610155|E2|Reported Event|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
1081993|NCT00610155|E1|Reported Event|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
1081994|NCT00610129|B1|Baseline|Patients With Metastatic Neuroendocrine Tumors|Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET)
1081995|NCT00610129|P1|Participant Flow|Patients With Metastatic Neuroendocrine Tumors|Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET)
1081996|NCT00610129|O1|Outcome|Patients With Metastatic Neuroendocrine Tumors|Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET)
1081997|NCT00610129|E1|Reported Event|Patients With Metastatic Neuroendocrine Tumors|Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET)
1081998|NCT00609986|B3|Baseline|Total|Total of all reporting groups
1081999|NCT00609986|B2|Baseline|Control|The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
1082000|NCT00609986|B1|Baseline|Intensive|The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
1082001|NCT00609986|P2|Participant Flow|Control|The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
1082002|NCT00609986|P1|Participant Flow|Intensive|The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
1082003|NCT00609986|O2|Outcome|Control|The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
1082004|NCT00609986|O1|Outcome|Intensive|The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
1082005|NCT00609986|O2|Outcome|Control|The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
1082006|NCT00609986|O1|Outcome|Intensive|The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
1082007|NCT00609986|O2|Outcome|Control|The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
1082008|NCT00609986|O1|Outcome|Intensive|The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
1082009|NCT00609986|O2|Outcome|Control|The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
1082010|NCT00609986|O1|Outcome|Intensive|The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
1082011|NCT00609986|E2|Reported Event|Control|The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
1082012|NCT00609986|E1|Reported Event|Intensive|The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
1082013|NCT00609973|B3|Baseline|Total|Total of all reporting groups
1082014|NCT00609973|B2|Baseline|Placebo|Placebo bid
1082015|NCT00609973|B1|Baseline|Cipro|Ciprofloxacin 500 mg bid
1082016|NCT00609973|P2|Participant Flow|Placebo|Placebo bid
1082017|NCT00609973|P1|Participant Flow|Cipro|Ciprofloxacin 500 mg bid
1082018|NCT00609973|O2|Outcome|Placebo|Placebo bid
1082019|NCT00609973|O1|Outcome|Cipro|Ciprofloxacin 500 mg bid
1082024|NCT00609947|B1|Baseline|Endeavor Zotarolimus-Eluting Coronary Stent|Zotarolimus-eluting stent (ZES) implanted using standard percutaneous coronary intervention (PCI) technique via the femoral approach
1082025|NCT00609947|P1|Participant Flow|Endeavor Zotarolimus-Eluting Coronary Stent|Zotarolimus-eltuing stent (ZES) implanted using standard percutaneous coronary intervention (PCI) technique via the femoral approach
1082026|NCT00609947|O1|Outcome|Primary Analysis Endpoint|
1082027|NCT00609947|O1|Outcome|Primary Effectiveness Analysis Endpoint - SVS|The 8-month in-segment diameter stenosis from Endeavor Small Vessel Study (SVS) subects
1082028|NCT00609947|E1|Reported Event|Primary Analysis Endpoint|"The first 97 subjects enrolled and implanted with 2.25mm stents~The first 39 subjects enrolled and implanted with 2.5mm stents~The first 40 subjects enrolled and implanted with 2.75mm stents~A supplemental safety analysis group of subjects with 2.25mm stents N=38 (included in 2.25mm group N=135)"
1082587|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082029|NCT00609869|B1|Baseline|Experimental: Lenalidomide and Rituximab|"28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.~Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.~Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15."
1082030|NCT00609869|P1|Participant Flow|Experimental: Lenalidomide and Rituximab|"28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.~Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.~Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15."
1082031|NCT00609869|O1|Outcome|Experimental: Lenalidomide and Rituximab|"28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.~Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.~Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15."
1082032|NCT00609869|O1|Outcome|Experimental: Lenalidomide and Rituximab|"28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.~Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.~Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15."
1082033|NCT00609869|O1|Outcome|Experimental: Lenalidomide and Rituximab|"28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.~Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.~Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15."
1082034|NCT00609869|E1|Reported Event|Experimental: Lenalidomide and Rituximab|"28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.~Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.~Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15."
1082035|NCT00609804|B3|Baseline|Total|Total of all reporting groups
1082036|NCT00609804|B2|Baseline|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
1082037|NCT00609804|B1|Baseline|Sorafenib+Erlotinib|Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
1082038|NCT00609804|P2|Participant Flow|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
1082039|NCT00609804|P1|Participant Flow|Sorafenib+Erlotinib|Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
1082040|NCT00609804|O2|Outcome|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
1082041|NCT00609804|O1|Outcome|Sorafenib and Erlotinib|Sorafenib and Erlotinib: Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
1082042|NCT00609804|O2|Outcome|Sorafenib|Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
1082043|NCT00609804|O1|Outcome|Sorafenib+Erlotinib|Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
1082044|NCT00609804|O2|Outcome|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
1082045|NCT00609804|O1|Outcome|Sorafenib+Erlotinib|Sorafenib and Erlotinib: Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
1082046|NCT00609804|E2|Reported Event|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
1082047|NCT00609804|E1|Reported Event|Sorafenib+Erlotinib|Sorafenib and Erlotinib: Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
1082048|NCT00609765|B1|Baseline|Chemotherapy|Prospective, single arm, Phase II
1082049|NCT00609765|P1|Participant Flow|Chemotherapy|Prospective, single arm, Phase II
1082050|NCT00609765|O1|Outcome|Chemotherapy|Prospective, single arm, Phase II
1082051|NCT00609765|O1|Outcome|Chemotherapy|Prospective, single arm, Phase II
1082052|NCT00609765|E1|Reported Event|Chemotherapy|Prospective, single arm, Phase II
1082053|NCT00609739|B1|Baseline|Cytarabine + Mitoxantrone|Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
1082054|NCT00609739|P1|Participant Flow|Cytarabine + Mitoxantrone|Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
1082055|NCT00609739|O1|Outcome|Cytarabine + Mitoxantrone|Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
1082056|NCT00609739|O1|Outcome|Cytarabine + Mitoxantrone|Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
1082057|NCT00609739|O1|Outcome|Cytarabine + Mitoxantrone|Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
1082058|NCT00609739|O1|Outcome|Cytarabine + Mitoxantrone|Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
1082059|NCT00609739|E1|Reported Event|Cytarabine + Mitoxantrone|Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
1082060|NCT00609674|B3|Baseline|Total|Total of all reporting groups
1082061|NCT00609674|B2|Baseline|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
1082062|NCT00609674|B1|Baseline|Placebo|Placebo nasal spray
1082063|NCT00609674|P2|Participant Flow|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
1082064|NCT00609674|P1|Participant Flow|Placebo|Placebo nasal spray
1082065|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
1082066|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
1082067|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
1082068|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
1082069|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
1082070|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
1082071|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
1082072|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
1082073|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
1082074|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
1082075|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
1082076|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
1082077|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
1082078|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
1082079|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
1082080|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
1082081|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
1082082|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
1082083|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
1082084|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
1082085|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
1082086|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
1082087|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
1082088|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
1082089|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
1082090|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
1082091|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
1082092|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
1082093|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
1082094|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
1082095|NCT00609674|E2|Reported Event|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
1082096|NCT00609674|E1|Reported Event|Placebo|Placebo nasal spray
1082097|NCT00609622|B3|Baseline|Total|Total of all reporting groups
1082098|NCT00609622|B2|Baseline|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
1082099|NCT00609622|B1|Baseline|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
1082271|NCT00609245|E1|Reported Event|Valproic Acid|Valproic Acid: The investigators will utilize intravenous sodium valproate at visit 3. Dosage will be individualized to each patient’s body weight, age, and hepatic-enzyme-inducing status. Intravenous Na VPA dose predictions will be based upon population VPA pharmacokinetic parameters (Dutta 2003).
1082100|NCT00609622|P2|Participant Flow|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kilogram (mg/kg) administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and a 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
1082117|NCT00609622|O1|Outcome|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
1082101|NCT00609622|P1|Participant Flow|Sunitinib + mFOLFOX6|Sunitinib 37.5 milligram (mg) capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, lecovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg per square meter (mg/m^2) and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour intravenous (IV) infusion followed by an IV bolus of 5-fluorouracil (5-FU) 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
1082102|NCT00609622|O2|Outcome|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
1082103|NCT00609622|O1|Outcome|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
1082104|NCT00609622|O2|Outcome|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
1082105|NCT00609622|O1|Outcome|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
1082106|NCT00609622|O2|Outcome|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
1082107|NCT00609622|O1|Outcome|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
1082108|NCT00609622|O2|Outcome|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
1082109|NCT00609622|O1|Outcome|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
1082110|NCT00609622|O2|Outcome|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
1082111|NCT00609622|O1|Outcome|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
1082112|NCT00609622|O2|Outcome|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
1082113|NCT00609622|O1|Outcome|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
1082114|NCT00609622|O2|Outcome|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
1082115|NCT00609622|O1|Outcome|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
1082272|NCT00609167|B3|Baseline|Total|Total of all reporting groups
1082116|NCT00609622|O2|Outcome|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
1082118|NCT00609622|E2|Reported Event|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
1082119|NCT00609622|E1|Reported Event|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
1082120|NCT00609518|B3|Baseline|Total|Total of all reporting groups
1082121|NCT00609518|B2|Baseline|Simplified Vitamin and Steroid Schedule + Pemetrexed|Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
1082122|NCT00609518|B1|Baseline|Standard Vitamin and Steroid Schedule + Pemetrexed|Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
1082123|NCT00609518|P2|Participant Flow|Simplified Vitamin and Steroid Schedule + Pemetrexed|Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
1082124|NCT00609518|P1|Participant Flow|Standard Vitamin and Steroid Schedule + Pemetrexed|Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
1082125|NCT00609518|O2|Outcome|Simplified Vitamin and Steroid Schedule + Pemetrexed|Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
1082126|NCT00609518|O1|Outcome|Standard Vitamin and Steroid Schedule + Pemetrexed|Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
1082127|NCT00609518|O2|Outcome|Simplified Vitamin and Steroid Schedule + Pemetrexed|Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
1082128|NCT00609518|O1|Outcome|Standard Vitamin and Steroid Schedule + Pemetrexed|Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
1082129|NCT00609518|O2|Outcome|Simplified Vitamin and Steroid Schedule + Pemetrexed|Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
1082130|NCT00609518|O1|Outcome|Standard Vitamin and Steroid Schedule + Pemetrexed|Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
1082131|NCT00609518|O2|Outcome|Simplified Vitamin and Steroid Schedule + Pemetrexed|Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
1082132|NCT00609518|O1|Outcome|Standard Vitamin and Steroid Schedule + Pemetrexed|Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
1082133|NCT00609518|E2|Reported Event|Simplified Vitamin and Steroid Schedule + Pemetrexed|Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
1082134|NCT00609518|E1|Reported Event|Standard Vitamin and Steroid Schedule + Pemetrexed|Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
1082135|NCT00609492|B4|Baseline|Total|Total of all reporting groups
1082136|NCT00609492|B3|Baseline|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082137|NCT00609492|B2|Baseline|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082138|NCT00609492|B1|Baseline|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082139|NCT00609492|P3|Participant Flow|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082275|NCT00609167|P2|Participant Flow|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
1082588|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082140|NCT00609492|P2|Participant Flow|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082141|NCT00609492|P1|Participant Flow|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082142|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082143|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082144|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082145|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082146|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082147|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082148|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082149|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082150|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082151|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082152|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid
1082153|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082154|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082307|NCT00608985|O3|Outcome|Almorexant 200mg|"almorexant 200 mg~almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
1082155|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082156|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082157|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082158|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082159|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082160|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082161|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082162|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082163|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082164|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082165|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082166|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082167|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082168|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082169|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082170|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082345|NCT00608959|E1|Reported Event|Omiganan 1% Gel (Part 1)|In Part 1 each subject had omiganan 1% gel applied to 6 sites located across the chest and/or abdomen.
1082171|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082172|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082173|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082174|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082175|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082176|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082177|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082178|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082179|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082180|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082181|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082182|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082183|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082184|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082185|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082186|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082346|NCT00608907|B4|Baseline|Total|Total of all reporting groups
1085009|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
1082187|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082188|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082189|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082190|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082191|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082192|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082193|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082194|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082195|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082196|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082197|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082198|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082199|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082200|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082201|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082202|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082577|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082203|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082204|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082205|NCT00609492|O3|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082206|NCT00609492|O2|Outcome|Preterm II Group|Children born after a gestation period of 31-36 weeks (217-258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082207|NCT00609492|O1|Outcome|Preterm I Group|Children born after a gestation period of 27-30 weeks (189-216 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082208|NCT00609492|O2|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082209|NCT00609492|O1|Outcome|Preterm Group|Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082210|NCT00609492|O2|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082211|NCT00609492|O1|Outcome|Preterm Group|Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082212|NCT00609492|O2|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082213|NCT00609492|O1|Outcome|Preterm Group|Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082214|NCT00609492|O2|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082215|NCT00609492|O1|Outcome|Preterm Group|Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082216|NCT00609492|O2|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082217|NCT00609492|O1|Outcome|Preterm Group|Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082218|NCT00609492|O2|Outcome|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082578|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082219|NCT00609492|O1|Outcome|Preterm Group|Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082220|NCT00609492|E2|Reported Event|Full Term Group|Children born after a gestation period of more than 36 weeks (more than 258 days) who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082221|NCT00609492|E1|Reported Event|Preterm Group|Pooled group with subjects from the Preterm I Group and the Preterm II Group who were previously vaccinated with three primary doses of Synflorix™ vaccine co-administered with Infanrix Hexa™ in study 10PN-PD-DIT-015 (107737), additionally received one booster dose of Synflorix™ vaccine co-administered with a single dose of Infanrix™-IPV/Hib vaccine, intramuscularly in the deltoid/thigh, at 16-18 months of age.
1082222|NCT00609466|B4|Baseline|Total|Total of all reporting groups
1082223|NCT00609466|B3|Baseline|Placebo|Matching Placebo 4 to 6 hourly
1082224|NCT00609466|B2|Baseline|Morphine|Morphine IR 30mg 4 to 6 hourly
1082225|NCT00609466|B1|Baseline|CG5503|CG5503 IR 75mg 4-6 hourly
1082226|NCT00609466|P3|Participant Flow|Placebo|Matching Placebo 4 to 6 hourly
1082227|NCT00609466|P2|Participant Flow|Morphine|Morphine IR 30mg 4 to 6 hourly
1082228|NCT00609466|P1|Participant Flow|CG5503|CG5503 IR 75mg 4-6 hourly
1082229|NCT00609466|O3|Outcome|Placebo|Matching Placebo 4 to 6 hourly
1082230|NCT00609466|O2|Outcome|Morphine|Morphine IR 30mg 4 to 6 hourly
1082231|NCT00609466|O1|Outcome|CG5503|CG5503 IR 75mg 4-6 hourly
1082232|NCT00609466|O3|Outcome|Placebo|Matching Placebo 4 to 6 hourly
1082233|NCT00609466|O2|Outcome|Morphine|Morphine IR 30mg 4 to 6 hourly
1082234|NCT00609466|O1|Outcome|CG5503|CG5503 IR 75mg 4-6 hourly
1082235|NCT00609466|O3|Outcome|Placebo|Matching Placebo 4 to 6 hourly
1082236|NCT00609466|O2|Outcome|Morphine|Morphine IR 30mg 4 to 6 hourly
1082237|NCT00609466|O1|Outcome|CG5503|CG5503 IR 75mg 4-6 hourly
1082238|NCT00609466|O3|Outcome|Placebo|Matching Placebo 4 to 6 hourly
1082239|NCT00609466|O2|Outcome|Morphine|Morphine IR 30mg 4 to 6 hourly
1082240|NCT00609466|O1|Outcome|CG5503|CG5503 IR 75mg 4-6 hourly
1082241|NCT00609466|O3|Outcome|Placebo|Matching Placebo 4 to 6 hourly
1082242|NCT00609466|O2|Outcome|Morphine|Morphine IR 30mg 4 to 6 hourly
1082243|NCT00609466|O1|Outcome|CG5503|CG5503 IR 75mg 4-6 hourly
1082244|NCT00609466|O3|Outcome|Placebo|Matching Placebo 4 to 6 hourly
1082245|NCT00609466|O2|Outcome|Morphine|Morphine IR 30mg 4 to 6 hourly
1082246|NCT00609466|O1|Outcome|CG5503|CG5503 IR 75mg 4-6 hourly
1082247|NCT00609466|O3|Outcome|Placebo|Matching Placebo 4 to 6 hourly
1082248|NCT00609466|O2|Outcome|Morphine|Morphine IR 30mg 4 to 6 hourly
1082249|NCT00609466|O1|Outcome|CG5503|CG5503 IR 75mg 4-6 hourly
1082250|NCT00609466|E3|Reported Event|Placebo|Matching Placebo 4 to 6 hourly
1082251|NCT00609466|E2|Reported Event|Morphine|Morphine IR 30mg 4 to 6 hourly
1082252|NCT00609466|E1|Reported Event|CG5503|CG5503 IR 75mg 4-6 hourly
1082253|NCT00609362|B3|Baseline|Total|Total of all reporting groups
1082254|NCT00609362|B2|Baseline|Placebo|25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
1082255|NCT00609362|B1|Baseline|Rosiglitazone|25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
1082256|NCT00609362|P2|Participant Flow|Placebo|25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
1082257|NCT00609362|P1|Participant Flow|Rosiglitazone|25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
1082258|NCT00609362|O2|Outcome|Placebo|25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
1082259|NCT00609362|O1|Outcome|Rosiglitazone|25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
1082260|NCT00609362|O2|Outcome|Placebo|25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
1082261|NCT00609362|O1|Outcome|Rosiglitazone|25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
1082262|NCT00609362|O2|Outcome|Placebo|25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
1082263|NCT00609362|O1|Outcome|Rosiglitazone|25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
1082264|NCT00609362|E2|Reported Event|Placebo|25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
1082265|NCT00609362|E1|Reported Event|Rosiglitazone|25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
1082266|NCT00609245|B1|Baseline|Valproate Infusion|"placebo: Each patient will have a placebo-infusion (with 0.9% NS or D5W) of 12-hour duration at visit 2.~Valproic Acid: The investigators will utilize intravenous sodium valproate at visit 3. Dosage will be individualized to each patient’s body weight, age, and hepatic-enzyme-inducing status. Intravenous Na VPA dose predictions will be based upon population VPA pharmacokinetic parameters (Dutta 2003)."
1082267|NCT00609245|P1|Participant Flow|Valproate Infusion|"placebo: Each patient will have a placebo-infusion (with 0.9% NS or D5W) of 12-hour duration at visit 2.~Valproic Acid: The investigators will utilize intravenous sodium valproate at visit 3. Dosage will be individualized to each patient’s body weight, age, and hepatic-enzyme-inducing status. Intravenous Na VPA dose predictions will be based upon population VPA pharmacokinetic parameters (Dutta 2003)."
1082268|NCT00609245|O2|Outcome|Valproic Acid|The investigators will utilize intravenous sodium valproate. Dosage will be individualized to each patient’s body weight, age, and hepatic-enzyme-inducing status. Intravenous Na VPA dose predictions will be based upon population VPA pharmacokinetic parameters (Dutta 2003).
1082269|NCT00609245|O1|Outcome|Placebo|Each patient will have a placebo-infusion (with 0.9% NS or D5W) of 12-hour duration.
1082270|NCT00609245|E2|Reported Event|Placebo|placebo: Each patient will have a placebo-infusion (with 0.9% NS or D5W) of 12-hour duration at visit 2.
1083411|NCT00606944|O1|Outcome|Control Group|traditional, conventional care group
1082273|NCT00609167|B2|Baseline|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
1082274|NCT00609167|B1|Baseline|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
1082276|NCT00609167|P1|Participant Flow|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
1082277|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
1082278|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
1082279|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
1082280|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
1082281|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
1082282|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
1082283|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
1082284|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
1082285|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
1082286|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
1082287|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
1082288|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
1082289|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
1082290|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
1082291|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
1082292|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
1082293|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
1082294|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
1082295|NCT00609167|E2|Reported Event|CyBorD (Bortezomib 1.5mg/m^2)|Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22 Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22 Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22
1082296|NCT00609167|E1|Reported Event|CyBorD (Bortezomib 1.3mg/m^2)|Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11 Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22 Dexamethasone 40mg PO days 1-4, 9-12, 17-20
1082297|NCT00608985|B5|Baseline|Total|Total of all reporting groups
1082298|NCT00608985|B4|Baseline|Zolpidem 10mg|"zolpidem 10 mg~zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
1082299|NCT00608985|B3|Baseline|Almorexant 200mg|"almorexant 200 mg~almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
1082300|NCT00608985|B2|Baseline|Almorexant 100mg|"almorexant 100 mg~almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
1082301|NCT00608985|B1|Baseline|Placebo|"Placebo~Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
1082302|NCT00608985|P4|Participant Flow|Zolpidem 10mg|"zolpidem 10 mg~zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
1082303|NCT00608985|P3|Participant Flow|Almorexant 200mg|"almorexant 200 mg~almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
1082304|NCT00608985|P2|Participant Flow|Almorexant 100mg|"almorexant 100 mg~almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
1082305|NCT00608985|P1|Participant Flow|Placebo|"Placebo~Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
1082306|NCT00608985|O4|Outcome|Zolpidem 10mg|"zolpidem 10 mg~zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
1085010|NCT00603525|O1|Outcome|Placebo|
1082308|NCT00608985|O2|Outcome|Almorexant 100mg|"almorexant 100 mg~almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
1082309|NCT00608985|O1|Outcome|Placebo|"Placebo~Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
1082310|NCT00608985|O4|Outcome|Zolpidem 10mg|"zolpidem 10 mg~zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
1082311|NCT00608985|O3|Outcome|Almorexant 200mg|"almorexant 200 mg~almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
1082312|NCT00608985|O2|Outcome|Almorexant 100mg|"almorexant 100 mg~almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
1082313|NCT00608985|O1|Outcome|Placebo|"Placebo~Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
1082314|NCT00608985|O4|Outcome|Zolpidem 10mg|"zolpidem 10 mg~zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
1082315|NCT00608985|O3|Outcome|Almorexant 200mg|"almorexant 200 mg~almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
1082316|NCT00608985|O2|Outcome|Almorexant 100mg|"almorexant 100 mg~almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
1082317|NCT00608985|O1|Outcome|Placebo|"Placebo~Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
1082318|NCT00608985|O4|Outcome|Zolpidem 10mg|"zolpidem 10 mg~zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
1082319|NCT00608985|O3|Outcome|Almorexant 200mg|"almorexant 200 mg~almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
1082320|NCT00608985|O2|Outcome|Almorexant 100mg|"almorexant 100 mg~almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
1082321|NCT00608985|O1|Outcome|Placebo|"Placebo~Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
1082322|NCT00608985|O4|Outcome|Zolpidem 10mg|"zolpidem 10 mg~zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
1082323|NCT00608985|O3|Outcome|Almorexant 200mg|"almorexant 200 mg~almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
1082324|NCT00608985|O2|Outcome|Almorexant 100mg|"almorexant 100 mg~almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
1082325|NCT00608985|O1|Outcome|Placebo|"Placebo~Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
1082326|NCT00608985|O4|Outcome|Zolpidem 10mg|"zolpidem 10 mg~zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
1082327|NCT00608985|O3|Outcome|Almorexant 200mg|"almorexant 200 mg~almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
1082328|NCT00608985|O2|Outcome|Almorexant 100mg|"almorexant 100 mg~almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
1082329|NCT00608985|O1|Outcome|Placebo|"Placebo~Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
1082330|NCT00608985|E4|Reported Event|Zolpidem 10mg|"zolpidem 10 mg~zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
1082331|NCT00608985|E3|Reported Event|Almorexant 200mg|"almorexant 200 mg~almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
1082332|NCT00608985|E2|Reported Event|Almorexant 100mg|"almorexant 100 mg~almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
1082333|NCT00608985|E1|Reported Event|Placebo|"Placebo~Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
1082334|NCT00608959|B3|Baseline|Total|Total of all reporting groups
1082335|NCT00608959|B2|Baseline|Chlorhexidine 2% (CHG) / Omiganan 1% Gel(Part 1)|25 subjects were treated with chlorhexidine 2% and omiganan 1% in Part 1.
1082336|NCT00608959|B1|Baseline|Omiganan 1% Gel (Part 2)|25 subjects were treated with omiganan 1% gel at skin and intravenous (IV) sites in Part 2.
1082337|NCT00608959|P1|Participant Flow|Omiganan 1% Gel and Chlorhexidine|"In Part 1 each subject had omiganan 1% gel applied to 6 sites located across the chest and/or abdomen and chlorhexidine applied to 6 matching sites on the contralateral side.Swab cultures were taken at specified timepoints over 72 hours.~In Part 2 each subject had omiganan 1% gel applied to 6 sites across the chest and/or abdomen.Swab cultures were taken at specified timepoints over 7 days.In addition subjects in Part 2 had 2 intravenous (IV) catheters inserted, with one catheter insertion site treated with isopropyl alcohol (prior to insertion) and omiganan 1% gel was applied. Catheter tip samples were taken at pre-specified timepoints over the 7 day period."
1082338|NCT00608959|O2|Outcome|Chlorhexidine 2%/ Isopropyl Alcohol|Subjects in Part 2 had 2 intravenous (IV) catheters inserted, with one catheter insertion site treated with chlorhexidine/isopropyl alcohol prior to catheter insertion.Catheter tip samples were taken at pre-specified timepoints over the 7 day period.
1082339|NCT00608959|O1|Outcome|Omiganan 1% Gel (Part 2)|Subjects in Part 2 had 2 intravenous (IV) catheters inserted, with one catheter insertion site treated with isopropyl alcohol (prior to insertion) and omiganan 1% gel was applied. Catheter tip samples were taken at pre-specified timepoints over the 7 day period.
1082340|NCT00608959|O1|Outcome|Omiganan 1% Gel (Part 2)|Omiganan 1% gel was applied to 6 sites across the chest and/or abdomen. Swab cultures were obtained at specified timepoints over a period of 7 days.
1082341|NCT00608959|O2|Outcome|Chlorhexidine 2%(Part 1)|Chlorhexidine 2% solution was applied to 6 sites on the chest and/or abdomen. Swab cultures were obtained at specific timepoints over 3 days.
1082342|NCT00608959|O1|Outcome|Omiganan 1% Gel (Part 2)|Omiganan 1% gel was applied to 6 sites across the chest and/or abdomen. Swab cultures were obtained at specified timepoints over a period of 3 days.
1082343|NCT00608959|E3|Reported Event|Omiganan 1% (Part 2)|In Part 2 each subject had omiganan 1% gel applied to 6 sites across the chest and/or abdomen.Omiganan 1% gel was applied to one intravenous (IV) catheter site.
1082344|NCT00608959|E2|Reported Event|Chlorhexidine|In Part 1 each subject had chlorhexidine 2% applied to 6 sites located across the chest and/or abdomen. In Part 2 subjects had chlorhexidine 2%/isopropyl alcohol applied to one intravenous (IV) catheter site.
1082347|NCT00608907|B3|Baseline|VELCADE + Dexamethasone|Treatment arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg oral tablet once daily days 1 to 4, and 9 to 12 in cycle 3.
1082348|NCT00608907|B2|Baseline|VELCADE + Rifampicin|Treatment Arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg oral tablet once daily days 4 to 10 in cycle 3.
1082349|NCT00608907|B1|Baseline|VELCADE|Control arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle.
1082350|NCT00608907|P3|Participant Flow|VELCADE + Dexamethasone|Treatment arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg oral tablet once daily days 1 to 4, and 9 to 12 in cycle 3.
1082351|NCT00608907|P2|Participant Flow|VELCADE + Rifampicin|Treatment Arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg oral tablet once daily days 4 to 10 in cycle 3.
1082352|NCT00608907|P1|Participant Flow|VELCADE|Control arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle.
1082353|NCT00608907|O3|Outcome|VELCADE|Control arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle.
1082354|NCT00608907|O2|Outcome|VELCADE + Dexamethasone|Treatment arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg oral tablet once daily days 1 to 4, and 9 to 12 in cycle 3.
1082355|NCT00608907|O1|Outcome|VELCADE + Rifampicin|Treatment Arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg oral tablet once daily days 4 to 10 in cycle 3.
1082356|NCT00608907|E3|Reported Event|VELCADE + Dexamethasone|Treatment arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg oral tablet once daily days 1 to 4, and 9 to 12 in cycle 3.
1082357|NCT00608907|E2|Reported Event|VELCADE + Rifampicin|Treatment Arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg oral tablet once daily days 4 to 10 in cycle 3.
1082358|NCT00608907|E1|Reported Event|VELCADE|Control arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle.
1082359|NCT00608881|B3|Baseline|Total|Total of all reporting groups
1082360|NCT00608881|B2|Baseline|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
1082361|NCT00608881|B1|Baseline|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
1082362|NCT00608881|P2|Participant Flow|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
1082363|NCT00608881|P1|Participant Flow|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
1082364|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
1082365|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
1082366|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
1082367|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
1082368|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
1082369|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
1082370|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
1082371|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
1082372|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
1082373|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
1082374|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
1082375|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
1082376|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
1082377|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
1082378|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
1082379|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
1082380|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
1082381|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
1082382|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
1082383|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
1082384|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
1082385|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
1082386|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
1082387|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
1082388|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
1082389|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
1082390|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
1082391|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
1082392|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
1082393|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
1082394|NCT00608881|E2|Reported Event|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
1082395|NCT00608881|E1|Reported Event|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
1082396|NCT00608868|B1|Baseline|Gefitinib|gefitinib tablet 250 mg orally
1082397|NCT00608868|P1|Participant Flow|Gefitinib|gefitinib tablet 250 mg orally
1082398|NCT00608868|O1|Outcome|Gefitinib|gefitinib tablet 250 mg orally
1082399|NCT00608868|O1|Outcome|Gefitinib|gefitinib tablet 250 mg orally
1082400|NCT00608868|O1|Outcome|Gefitinib|gefitinib tablet 250 mg orally
1082401|NCT00608868|O1|Outcome|Gefitinib|gefitinib tablet 250 mg orally
1082402|NCT00608868|E1|Reported Event|Gefitinib|gefitinib tablet 250 mg orally
1082403|NCT00608842|B5|Baseline|Total|Total of all reporting groups
1082404|NCT00608842|B4|Baseline|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082405|NCT00608842|B3|Baseline|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082406|NCT00608842|B2|Baseline|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082407|NCT00608842|B1|Baseline|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082408|NCT00608842|P4|Participant Flow|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082409|NCT00608842|P3|Participant Flow|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082410|NCT00608842|P2|Participant Flow|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082411|NCT00608842|P1|Participant Flow|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082412|NCT00608842|O4|Outcome|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082413|NCT00608842|O3|Outcome|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082414|NCT00608842|O2|Outcome|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082415|NCT00608842|O1|Outcome|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082416|NCT00608842|O4|Outcome|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082417|NCT00608842|O3|Outcome|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082418|NCT00608842|O2|Outcome|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082419|NCT00608842|O1|Outcome|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082420|NCT00608842|O4|Outcome|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082421|NCT00608842|O3|Outcome|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082422|NCT00608842|O2|Outcome|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082423|NCT00608842|O1|Outcome|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082424|NCT00608842|O4|Outcome|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082425|NCT00608842|O3|Outcome|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082426|NCT00608842|O2|Outcome|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082427|NCT00608842|O1|Outcome|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082589|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082428|NCT00608842|O4|Outcome|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082429|NCT00608842|O3|Outcome|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082430|NCT00608842|O2|Outcome|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082431|NCT00608842|O1|Outcome|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082432|NCT00608842|O4|Outcome|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082433|NCT00608842|O3|Outcome|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082434|NCT00608842|O2|Outcome|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082435|NCT00608842|O1|Outcome|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082436|NCT00608842|O4|Outcome|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082437|NCT00608842|O3|Outcome|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082438|NCT00608842|O2|Outcome|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082439|NCT00608842|O1|Outcome|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082440|NCT00608842|E4|Reported Event|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082441|NCT00608842|E3|Reported Event|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082442|NCT00608842|E2|Reported Event|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082443|NCT00608842|E1|Reported Event|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
1082444|NCT00608829|B1|Baseline|45mm TAG Device Subjects|The TAG device is a flexible, self-expanding stent graft used for endovascular repair of the Descending Thoracic Aorta. The 45 mm TAG device is a true “line extension”, as it is identical to the approved 26-40 mm GORE TAG Thoracic Endoprosthesis, with the exception of the diameter.
1082445|NCT00608829|P1|Participant Flow|45mm TAG Device Subjects|The TAG device is a flexible, self-expanding stent graft used for endovascular repair of the Descending Thoracic Aorta. The 45 mm TAG device is a true “line extension”, as it is identical to the approved 26-40 mm GORE TAG Thoracic Endoprosthesis, with the exception of the diameter.
1082446|NCT00608829|O1|Outcome|45mm TAG Device Subjects|The TAG device is a flexible, self-expanding stent graft used for endovascular repair of the Descending Thoracic Aorta. The 45 mm TAG device is a true “line extension”, as it is identical to the approved 26-40 mm GORE TAG Thoracic Endoprosthesis, with the exception of the diameter.
1082447|NCT00608829|E1|Reported Event|45mm TAG Device Subjects|The TAG device is a flexible, self-expanding stent graft used for endovascular repair of the Descending Thoracic Aorta. The 45 mm TAG device is a true “line extension”, as it is identical to the approved 26-40 mm GORE TAG Thoracic Endoprosthesis, with the exception of the diameter.
1082448|NCT00608777|B1|Baseline|Open Label Taclonex|
1082449|NCT00608777|P1|Participant Flow|Open Label Taclonex|
1082450|NCT00608777|O1|Outcome|Open Label Taclonex|
1082451|NCT00608777|E1|Reported Event|Open Label|
1082452|NCT00608634|B4|Baseline|Total|Total of all reporting groups
1082453|NCT00608634|B3|Baseline|Arm III|Patients apply POH cream (0.76%) as in arm II.
1082454|NCT00608634|B2|Baseline|Arm II|Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
1082455|NCT00608634|B1|Baseline|Arm I|Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
1082456|NCT00608634|P3|Participant Flow|High Dose POH 0.76%|Patients apply POH cream (0.76%) as in arm II.
1082457|NCT00608634|P2|Participant Flow|Low Dose POH 0.30%|Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
1082458|NCT00608634|P1|Participant Flow|Placbeo|Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
1082459|NCT00608634|O3|Outcome|High Dose 0.76% POH|Patients apply POH cream (0.76%) as in arm II.
1082460|NCT00608634|O2|Outcome|Low Dose 0.30% POH|Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
1082461|NCT00608634|O1|Outcome|Placebo|Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
1082462|NCT00608634|O3|Outcome|High Dose POH 0.76%|Patients apply POH cream (0.76%) as in arm II.
1082463|NCT00608634|O2|Outcome|Low Dose POH 0.30%|Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
1082464|NCT00608634|O1|Outcome|Placebo|Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
1082465|NCT00608634|E3|Reported Event|High Dose POH 0.76%|Patients apply POH cream (0.76%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
1082466|NCT00608634|E2|Reported Event|Low Dose POH 0.3%|Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
1082467|NCT00608634|E1|Reported Event|Placebo|Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
1082468|NCT00608582|B3|Baseline|Total|Total of all reporting groups
1082469|NCT00608582|B2|Baseline|Sham rTMS|"These patients receive a series of 10 Sham rTMS treatments, which are identical to the Real rTMS treatments. However, no magnetic pulse is emitted from the coil.~The patients then receive a series of 10 Real rTMS treatments. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.~Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
1082470|NCT00608582|B1|Baseline|Real rTMS|"These patients receive a series of 10 Real rTMS treatments, only. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.~Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
1082471|NCT00608582|P2|Participant Flow|Sham rTMS|"These patients receive a series of 10 Sham rTMS treatments, which are identical to the Real rTMS treatments. However, no magnetic pulse is emitted from the coil.~There is pre-testing, and post-testing at 2 months after the last Sham rTMS treatment.~The patients then receive a series of 10 Real rTMS treatments.~Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
1082472|NCT00608582|P1|Participant Flow|Real rTMS|"These patients receive a series of 10 Real rTMS treatments, only. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.~Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
1082473|NCT00608582|O2|Outcome|Sham rTMS|"These patients receive a series of 10 Sham rTMS treatments, which are identical to the Real rTMS treatments. However, no magnetic pulse is emitted from the coil.~There is pre-testing, and post-testing at 2 months after the last Sham rTMS treatment.~The patients then receive a series of 10 Real rTMS treatments.~Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
1082474|NCT00608582|O1|Outcome|Real rTMS|"These patients receive a series of 10 Real rTMS treatments, only. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.~Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
1082475|NCT00608582|O2|Outcome|Sham rTMS|Patients receive a series of 10 Sham Transcranial Magnetic Stimulation, Repetitive (rTMS) treatments, followed by a series of 10 Real rTMS treatments. Sham rTMS are identical to the Real rTMS treatments only no magnetic pulse is released. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.
1082476|NCT00608582|O1|Outcome|Real rTMS|"These patients receive a series of 10 Real Transcranial Magnetic Stimulation, Repetitive (rTMS) , treatments, only. There is pre-testing and post-testing at 2 months after the last Real rTMS treatment.~Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
1082477|NCT00608582|E2|Reported Event|Sham rTMS|Patients receive a series of 10 Sham Transcranial Magnetic Stimulation, Repetitive (rTMS) treatments, followed by a series of 10 Real rTMS treatments. There is pre-testing, and post-testing at 2 months after the last Sham rTMS treatment. Sham rTMS are identical to the Real rTMS treatments only no magnetic pulse is released. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.
1082510|NCT00608543|E1|Reported Event|Open-label Aripiprazole Augmentation|Aripiprazole augmentation of existing escitalopram, citalopram, or sertraline treatment was provided to study participants at a flexible dose between 5-15 mg (based on clinical symptoms and side effects) for 6 weeks
1082511|NCT00608530|B3|Baseline|Total|Total of all reporting groups
1082590|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082478|NCT00608582|E1|Reported Event|Real rTMS|"These patients receive a series of 10 Real Transcranial Magnetic Stimulation, Repetitive (rTMS) , treatments, only. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.~Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
1082479|NCT00608569|B3|Baseline|Total|Total of all reporting groups
1082480|NCT00608569|B2|Baseline|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
1082481|NCT00608569|B1|Baseline|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
1082482|NCT00608569|P2|Participant Flow|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
1082483|NCT00608569|P1|Participant Flow|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
1082484|NCT00608569|O2|Outcome|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
1082485|NCT00608569|O1|Outcome|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
1082486|NCT00608569|O2|Outcome|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
1082487|NCT00608569|O1|Outcome|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
1082488|NCT00608569|O2|Outcome|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
1082489|NCT00608569|O1|Outcome|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
1082490|NCT00608569|O2|Outcome|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
1082491|NCT00608569|O1|Outcome|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
1082492|NCT00608569|O2|Outcome|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
1082493|NCT00608569|O1|Outcome|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
1082494|NCT00608569|O2|Outcome|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
1082495|NCT00608569|O1|Outcome|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
1082496|NCT00608569|O2|Outcome|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
1082497|NCT00608569|O1|Outcome|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
1082498|NCT00608569|O2|Outcome|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
1082499|NCT00608569|O1|Outcome|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
1082500|NCT00608569|E2|Reported Event|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
1082501|NCT00608569|E1|Reported Event|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
1082502|NCT00608543|B1|Baseline|Open-label Aripiprazole Augmentation|Aripiprazole augmentation of existing escitalopram, citalopram, or sertraline treatment was provided to study participants at a flexible dose between 5-15 mg (based on clinical symptoms and side effects) for 6 weeks
1082503|NCT00608543|P1|Participant Flow|Open-label Aripiprazole Augmentation|Aripiprazole augmentation of existing escitalopram, citalopram, or sertraline treatment was provided to study participants at a flexible dose between 5-15 mg (based on clinical symptoms and side effects) for 6 weeks
1082504|NCT00608543|O1|Outcome|Open Label Aripiprazole Augmentation|This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
1082505|NCT00608543|O1|Outcome|Spatial Working Memory Between Errors for 6-move Problems|This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
1082506|NCT00608543|O1|Outcome|Open Label Aripiprazole Augmentation|This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
1082507|NCT00608543|O1|Outcome|Open Label Aripiprazole Augmentation|This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
1082508|NCT00608543|O1|Outcome|Open Label Aripiprazole Augmentation|This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
1082509|NCT00608543|O1|Outcome|Open Label Aripiprazole Augmentation|This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
1082579|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082512|NCT00608530|B2|Baseline|Supportive Psychotherapy|"10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact~Rogerian psychotherapy: Rogerian therapy encourages self-identification of goals and solutions using a supportive but not directive approach"
1082513|NCT00608530|B1|Baseline|Cognitive Behavioral Therapy|"10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact~Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms (e.g., pain) and set specifc goals for functioning (e.g., walking 30 minutes daily)."
1082514|NCT00608530|P2|Participant Flow|Supportive Psychotherapy|"10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact~Rogerian psychotherapy: Rogerian therapy encourages self-identification of goals and solutions using a supportive but not didactic approach"
1082515|NCT00608530|P1|Participant Flow|Cognitive Behavioral Therapy|"10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact~Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms"
1082516|NCT00608530|O2|Outcome|Supportive Care|10 hours of Rogerian (Supportive) Psychotherapy delivered over 8 weeks
1082517|NCT00608530|O1|Outcome|Cognitive Behavioral Therapy|10 hours of Cognitive Behavioral Therapy delivered over 8 weeks
1082518|NCT00608530|O2|Outcome|Supportive Care|10 hours of Rogerian (Supportive) Psychotherapy delivered over 8 weeks
1082519|NCT00608530|O1|Outcome|Cognitive Behavioral Therapy|10 hours of Cognitive Behavioral Therapy delivered over 8 weeks
1082520|NCT00608530|O2|Outcome|Supportive Psychotherapy|"10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact~Rogerian psychotherapy: Rogerian therapy encourages self-identification of goals and solutions using a supportive but not directive approach"
1082521|NCT00608530|O1|Outcome|Cognitive Behavioral Therapy|"10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact~Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms (e.g., pain) and set specifc goals for functioning (e.g., walking 30 minutes daily)."
1082522|NCT00608530|E2|Reported Event|Supportive Psychotherapy|"10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact~Rogerian psychotherapy: Rogerian therapists encourage individuals to identify goals and solutions using a supportive, reflective, empathic appraoch rather than a directive or prescriptive approach"
1082523|NCT00608530|E1|Reported Event|Cognitive Behavioral Therapy|"10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact~Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms"
1082524|NCT00608517|B4|Baseline|Total|Total of all reporting groups
1082525|NCT00608517|B3|Baseline|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
1082526|NCT00608517|B2|Baseline|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
1082527|NCT00608517|B1|Baseline|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
1082528|NCT00608517|P3|Participant Flow|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
1082529|NCT00608517|P2|Participant Flow|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
1082530|NCT00608517|P1|Participant Flow|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
1082531|NCT00608517|O3|Outcome|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
1082532|NCT00608517|O2|Outcome|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
1082533|NCT00608517|O1|Outcome|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
1082534|NCT00608517|O3|Outcome|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
1082535|NCT00608517|O2|Outcome|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
1082536|NCT00608517|O1|Outcome|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
1082537|NCT00608517|O3|Outcome|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
1082580|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082538|NCT00608517|O2|Outcome|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
1082585|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082539|NCT00608517|O1|Outcome|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
1082540|NCT00608517|O3|Outcome|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
1082541|NCT00608517|O2|Outcome|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
1082542|NCT00608517|O1|Outcome|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
1082543|NCT00608517|O3|Outcome|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
1082544|NCT00608517|O2|Outcome|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
1082545|NCT00608517|O1|Outcome|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
1082546|NCT00608517|O3|Outcome|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
1082547|NCT00608517|O2|Outcome|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
1082548|NCT00608517|O1|Outcome|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours
1082549|NCT00608517|O3|Outcome|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
1082550|NCT00608517|O2|Outcome|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
1082551|NCT00608517|O1|Outcome|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
1082552|NCT00608517|E3|Reported Event|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
1082553|NCT00608517|E2|Reported Event|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
1082554|NCT00608517|E1|Reported Event|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
1082555|NCT00608491|B3|Baseline|Total|Total of all reporting groups
1082556|NCT00608491|B2|Baseline|Ultrafiltration|Participants will receive ultrafiltration
1082557|NCT00608491|B1|Baseline|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082558|NCT00608491|P2|Participant Flow|Ultrafiltration|Participants will receive ultrafiltration
1082559|NCT00608491|P1|Participant Flow|Stepped Pharmacologic Care|Stepped care will provide treating physicians with guidelines for the intensification of diuretic therapy and the possible use of vasodilators and inotropes
1082560|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082561|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082562|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082563|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082564|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082565|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082566|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082567|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082568|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082569|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082570|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082571|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082572|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082573|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082574|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082575|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082576|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082583|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082584|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082591|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082592|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082593|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082594|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082595|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082596|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082597|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082598|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082599|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082600|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082601|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082602|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082603|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082604|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082605|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082606|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082607|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082608|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082609|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082610|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082611|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082612|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082613|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082614|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082615|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082616|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082617|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082618|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082619|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082620|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082621|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082622|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082623|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082624|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082625|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082626|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082627|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082628|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082629|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082630|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082631|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082632|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082633|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082634|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082635|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082636|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082637|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082638|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082639|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082640|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082641|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082642|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082643|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082644|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082645|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082647|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082648|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082649|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082650|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082651|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082652|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082653|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082654|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082655|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082656|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082657|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082658|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082659|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082660|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082661|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082662|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082663|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082664|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082665|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082666|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082667|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082668|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082669|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082670|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082671|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082672|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082673|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082674|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082675|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082676|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082677|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082678|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082679|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082680|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082681|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082682|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082683|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082684|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082685|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082686|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082687|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082688|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082689|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082690|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082691|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082692|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082693|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082694|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082695|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082696|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082697|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082698|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
1082699|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082700|NCT00608491|E2|Reported Event|Ultrafiltration|Participants will receive ultrafiltration
1082701|NCT00608491|E1|Reported Event|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
1082702|NCT00608465|B1|Baseline|All Patients|The study was never unblinded as enrollment was never completed.
1082703|NCT00608465|P1|Participant Flow|All Patients|The study was never unblinded as enrollment was never completed.
1082704|NCT00608465|O1|Outcome|All Patients|The study was never unblinded as enrollment was never completed.
1082705|NCT00608465|O1|Outcome|All Patients|The study was never unblinded as enrollment was never completed.
1082706|NCT00608465|E1|Reported Event|All Patients|The study was never unblinded as enrollment was never completed.
1082707|NCT00608426|B3|Baseline|Total|Total of all reporting groups
1082739|NCT00608205|B2|Baseline|Arm B: Radiation With Concurrent 5-FU and Cisplatin|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082708|NCT00608426|B2|Baseline|Proactive Care|"Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).~Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care)."
1082709|NCT00608426|B1|Baseline|Usual Care|Group who can elect to receive reactive (usual) care for smoking cessation.
1082742|NCT00608205|P1|Participant Flow|Arm A: Radiation With Concurrent Cisplatin|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1083110|NCT00607672|O2|Outcome|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
1082710|NCT00608426|P2|Participant Flow|Proactive Care|"Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).~Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care)."
1082711|NCT00608426|P1|Participant Flow|Usual Care|Group who can elect to receive reactive (usual) care for smoking cessation.
1082712|NCT00608426|O2|Outcome|Proactive Care|"Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).~Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care)."
1082713|NCT00608426|O1|Outcome|Usual Care|Group who can elect to receive reactive (usual) care for smoking cessation.
1082714|NCT00608426|O2|Outcome|Proactive Care|"Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).~Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care)."
1082715|NCT00608426|O1|Outcome|Usual Care|Group who can elect to receive reactive (usual) care for smoking cessation.
1082716|NCT00608426|O2|Outcome|Proactive Care|"Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).~Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care)."
1082717|NCT00608426|O1|Outcome|Usual Care|Group who can elect to receive reactive (usual) care for smoking cessation.
1082718|NCT00608426|E2|Reported Event|Proactive Care|"Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).~Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care)."
1082719|NCT00608426|E1|Reported Event|Usual Care|Group who can elect to receive reactive (usual) care for smoking cessation.
1082720|NCT00608322|B3|Baseline|Total|Total of all reporting groups
1082721|NCT00608322|B2|Baseline|Sham (Comparator)|Subjects receive sham inhaled nitric oxide for six hours.
1082722|NCT00608322|B1|Baseline|Inhaled Nitric Oxide|Subjects receive inhaled nitric oxide (40 parts per million) for six hours.
1082723|NCT00608322|P2|Participant Flow|Sham (Comparator)|Subjects receive sham inhaled nitric oxide for six hours.
1082724|NCT00608322|P1|Participant Flow|Inhaled Nitric Oxide|Subjects receive inhaled nitric oxide (40 parts per million) for six hours.
1082725|NCT00608322|O2|Outcome|Sham (Comparator)|Subjects receive sham inhaled nitric oxide for six hours.
1082726|NCT00608322|O1|Outcome|Inhaled Nitric Oxide|Subjects receive inhaled nitric oxide (40 parts per million) for six hours.
1082727|NCT00608322|E2|Reported Event|Sham (Comparator)|Subjects receive sham inhaled nitric oxide for six hours.
1082728|NCT00608322|E1|Reported Event|Inhaled Nitric Oxide|Subjects receive inhaled nitric oxide (40 parts per million) for six hours.
1082729|NCT00608244|B1|Baseline|LCP-Tacro|Evaluation of steady state tacrolimus exposure (AUC0-24) and trough levels (C24) in stable liver transplant recipients converted from Prograf to LCP-Tacro in a 3-sequence study design and validate the dose conversion ratio determined in the Phase 1 program.
1082730|NCT00608244|P1|Participant Flow|LCP-Tacro|"All Patients received Prograf for 7 days, then all patients were converted to once daily LCP-Tacro for 14 days. One dose adjustment up or down 25% was permitted on Day 15.~On Day 22, patients were converted back to their original twice daily dose of Prograf for a safety follow-up period of 30 days.~LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL."
1082731|NCT00608244|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL.
1082732|NCT00608244|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL.
1082733|NCT00608244|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL.
1082734|NCT00608244|O1|Outcome|Prograf|Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally twice daily, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL.
1082735|NCT00608244|O1|Outcome|Prograf|Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally twice daily, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL.
1082736|NCT00608244|E2|Reported Event|Prograf|"Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally twice daily, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL.~59 patients were enrolled into the study and all 59 were dosed with Prograf. Adverse Events occurring during the follow up period (Days 22-51) have been counted in the Prograf treatment arm as patients were on Prograf during this period."
1082737|NCT00608244|E1|Reported Event|LCP-Tacro|"LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL.~59 patients were enrolled into the study and all 59 were dosed with LCP-Tacro."
1082738|NCT00608205|B3|Baseline|Total|Total of all reporting groups
1082740|NCT00608205|B1|Baseline|Arm A: Radiation With Concurrent Cisplatin|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082741|NCT00608205|P2|Participant Flow|Arm B: Radiation With Concurrent 5-FU and Cisplatin|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082858|NCT00608023|O1|Outcome|Tesamorelin (52 Weeks)|Tesamorelin 2 mg/day for 52 weeks
1082743|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082744|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082745|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082746|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082747|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082748|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082749|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082750|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082751|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082752|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082753|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082754|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082755|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082756|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082757|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082758|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082759|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082760|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082761|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082762|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082763|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082764|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082765|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082766|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082767|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082768|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082769|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082770|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082771|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082772|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082773|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082774|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1083100|NCT00607672|O3|Outcome|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
1082775|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082776|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082777|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1083109|NCT00607672|O3|Outcome|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
1082778|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082779|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082780|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082781|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082782|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082783|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082784|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082785|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082786|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082787|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082788|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082789|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082790|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082791|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082792|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082793|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082794|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082795|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082796|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082797|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082798|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082799|NCT00608205|O2|Outcome|Radiation With Concurrent 5-FU and Cisplatin|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082800|NCT00608205|O1|Outcome|Radiation With Concurrent Cisplatin|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082801|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082802|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082803|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082804|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082805|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082806|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082807|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082808|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082809|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082810|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082811|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082812|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082813|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082814|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082815|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082816|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082817|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082818|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082819|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082820|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082821|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082822|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082823|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082824|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082825|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082826|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082827|NCT00608205|E2|Reported Event|Arm B: Radiation With Concurrent 5-FU and Cisplatin|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
1082828|NCT00608205|E1|Reported Event|Arm A: Radiation With Concurrent Cisplatin|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
1082829|NCT00608140|B3|Baseline|Total|Total of all reporting groups
1082830|NCT00608140|B2|Baseline|2 Medical Therapy Only|Participants will receive optimal medical therapy alone
1082831|NCT00608140|B1|Baseline|1 Medical Therapy Plus Surgical Repair|Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement
1082832|NCT00608140|P2|Participant Flow|2 Medical Therapy Only|Participants will receive optimal medical therapy alone
1082833|NCT00608140|P1|Participant Flow|1 Medical Therapy Plus Surgery|Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement
1082834|NCT00608140|O2|Outcome|2 Medical Therapy Only|Participants will receive optimal medical therapy alone
1082835|NCT00608140|O1|Outcome|1 Medical Therapy Plus Surgery|Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement
1082836|NCT00608140|O2|Outcome|2 Medical Therapy Only|Participants will receive optimal medical therapy alone
1082837|NCT00608140|O1|Outcome|1 Medical Therapy Plus Surgery|Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement
1082838|NCT00608140|E2|Reported Event|2 Medical Therapy Only|Participants will receive optimal medical therapy alone
1082839|NCT00608140|E1|Reported Event|1 Medical Therapy Plus Surgery|Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement
1082840|NCT00608023|B4|Baseline|Total|Total of all reporting groups
1082841|NCT00608023|B3|Baseline|Placebo (26 Weeks) - Tesamorelin (26 Weeks)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
1082842|NCT00608023|B2|Baseline|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
1082843|NCT00608023|B1|Baseline|Tesamorelin 52 Weeks|Tesamorelin 2 mg/day for 52 weeks
1082844|NCT00608023|P3|Participant Flow|Placebo-Tesamorelin (P-T)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
1082845|NCT00608023|P2|Participant Flow|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
1082846|NCT00608023|P1|Participant Flow|Tesamorelin (52 Weeks)|Tesamorelin 2 mg/day for 52 Weeks
1082847|NCT00608023|O3|Outcome|Placebo (26 Weeks) - Tesamorelin (26 Weeks)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
1082848|NCT00608023|O2|Outcome|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
1082849|NCT00608023|O1|Outcome|Tesamorelin 52 Weeks|Tesamorelin 2 mg/day for 52 weeks
1082850|NCT00608023|O3|Outcome|Placebo (26 Weeks) - Tesamorelin (26 Weeks)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
1082851|NCT00608023|O2|Outcome|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
1082852|NCT00608023|O1|Outcome|Tesamorelin 52 Weeks|Tesamorelin 2 mg/day for 52 weeks
1082853|NCT00608023|O3|Outcome|Placebo (26 Weeks) - Tesamorelin (26 Weeks)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
1082854|NCT00608023|O2|Outcome|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
1082855|NCT00608023|O1|Outcome|Tesamorelin 52 Weeks|Tesamorelin 2 mg/day for 52 weeks
1082856|NCT00608023|O3|Outcome|Placebo (26 Weeks) - Tesamorelin (26 Weeks)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks.
1082857|NCT00608023|O2|Outcome|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks.
1082859|NCT00608023|O3|Outcome|Placebo (26 Weeks) - Tesamorelin (26 Weeks)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
1082860|NCT00608023|O2|Outcome|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
1082861|NCT00608023|O1|Outcome|Tesamorelin 52 Weeks|Tesamorelin 2 mg/day for 52 weeks
1082862|NCT00608023|E3|Reported Event|Placebo (26 Weeks) - Tesamorelin (26 Weeks)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
1082863|NCT00608023|E2|Reported Event|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
1082864|NCT00608023|E1|Reported Event|Tesamorelin 52 Weeks|Tesamorelin 2 mg/day for 52 weeks
1082865|NCT00607919|B3|Baseline|Total|Total of all reporting groups
1082866|NCT00607919|B2|Baseline|Placebo/Atomoxetine|"Participants were assigned to placebo in acute phase and Atomoxetine in open-label phase.~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082867|NCT00607919|B1|Baseline|Atomoxetine/Atomoxetine|"Participants were assigned to Atomoxetine treatment in both acute and open-label phase~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082868|NCT00607919|P2|Participant Flow|Placebo/Atomoxetine|"Participants were assigned to placebo in acute phase and Atomoxetine in open-label phase.~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082869|NCT00607919|P1|Participant Flow|Atomoxetine/Atomoxetine|"Participants were assigned to Atomoxetine treatment in both acute and open-label phase~Atomoxetine was administered at 1.0 to 1.4 milligram/kilogram/day (mg/kg/day) given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082870|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082871|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082872|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082873|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082874|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082875|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082876|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082877|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082929|NCT00607880|O2|Outcome|Vortex Implantable Access Port|Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
1083101|NCT00607672|O2|Outcome|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
1082878|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082932|NCT00607880|O1|Outcome|Standard Access Port|Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
1082879|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082880|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082881|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082882|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082883|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082884|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082885|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082886|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082887|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082888|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082889|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082890|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082891|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082892|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082893|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1083094|NCT00607672|O3|Outcome|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
1082894|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082895|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082896|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082897|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082898|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082899|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082900|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082901|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082902|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082903|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082904|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082905|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082906|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082907|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082908|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082909|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1085011|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
1082910|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082911|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082912|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082913|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082914|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082915|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082916|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082917|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082918|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082919|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082920|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082921|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082922|NCT00607919|E2|Reported Event|Placebo/Atomoxetine|"Participants were assigned to placebo in acute phase and Atomoxetine in open-label phase.~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
1082923|NCT00607919|E1|Reported Event|Atomoxetine/Atomoxetine|"Participants were assigned to Atomoxetine treatment in both acute and open-label phase~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with atomoxetine"
1082924|NCT00607880|B3|Baseline|Total|Total of all reporting groups
1082925|NCT00607880|B2|Baseline|Vortex Implantable Access Port|Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
1082926|NCT00607880|B1|Baseline|Standard Access Port|Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
1082927|NCT00607880|P2|Participant Flow|Vortex Implantable Access Port|Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
1082928|NCT00607880|P1|Participant Flow|Standard Access Port|Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
1082930|NCT00607880|O1|Outcome|Standard Access Port|Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
1082931|NCT00607880|O2|Outcome|Vortex Implantable Access Port|Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
1082933|NCT00607880|O2|Outcome|Vortex Implantable Access Port|Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
1082934|NCT00607880|O1|Outcome|Standard Access Port|Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
1082935|NCT00607880|O2|Outcome|Vortex Implantable Access Port|Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
1082936|NCT00607880|O1|Outcome|Standard Access Port|Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
1082937|NCT00607880|E2|Reported Event|Vortex Implantable Access Port|Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
1082938|NCT00607880|E1|Reported Event|Standard Access Port|Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
1082939|NCT00607867|B3|Baseline|Total|Total of all reporting groups
1082940|NCT00607867|B2|Baseline|Control Diet|A weight maintenance, control diet consisting 55% carbohydrate, 15% protein, 30% fat
1082941|NCT00607867|B1|Baseline|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% carbohydrate, 30% protein, and 40% fat.
1082942|NCT00607867|P2|Participant Flow|Control Diet|A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
1082943|NCT00607867|P1|Participant Flow|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
1082944|NCT00607867|O2|Outcome|Control Diet|A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
1082945|NCT00607867|O1|Outcome|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
1082946|NCT00607867|O2|Outcome|Control Diet|A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
1082947|NCT00607867|O1|Outcome|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
1082948|NCT00607867|O2|Outcome|Control Diet|A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
1082949|NCT00607867|O1|Outcome|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
1082950|NCT00607867|O2|Outcome|Control Diet|A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
1082951|NCT00607867|O1|Outcome|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
1082952|NCT00607867|O2|Outcome|Control Diet|A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
1082953|NCT00607867|O1|Outcome|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
1082954|NCT00607867|O2|Outcome|Control Diet|A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
1082955|NCT00607867|O1|Outcome|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
1082956|NCT00607867|E2|Reported Event|Control Diet|"A weight maintenance, control diet consisting of 55% carbohydrate, 15% protein, 30% fat will be given to subjects on metformin. All food will be provided for 5 weeks.~Control Diet: A control diet consists of 55% of total energy intake as carbohydrate, 15% protein, 30% fat"
1082957|NCT00607867|E1|Reported Event|LoBAG30 Diet|"A LoBAG30, weight maintenance diet will be given to subjects on metformin. All food will be provided for 5 weeks.~LoBAG30 diet: A LoBAG30 diet consists of 30% of total energy intake as carbohydrate, 30% protein, and 40% fat."
1082958|NCT00607815|B3|Baseline|Total|Total of all reporting groups
1082959|NCT00607815|B2|Baseline|Present Centered Therapy|"Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
1082960|NCT00607815|B1|Baseline|Cognitive Processing Therapy|Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others.
1082961|NCT00607815|P2|Participant Flow|Present Centered Therapy|"Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
1082962|NCT00607815|P1|Participant Flow|Cognitive Processing Therapy|Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others.
1082963|NCT00607815|O2|Outcome|Present Centered Therapy|"Present Centered Therapy~Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
1085012|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
1082964|NCT00607815|O1|Outcome|Cognitive Processing Therapy|"Cognitive Processing Therapy~Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others."
1082990|NCT00607724|B4|Baseline|Stage 2: Basal Cell Carcinoma [GDC-0449 (150 mg)]|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
1082965|NCT00607815|O2|Outcome|Present Centered Therapy|"Present Centered Therapy~Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
1082966|NCT00607815|O1|Outcome|Cognitive Processing Therapy|"Cognitive Processing Therapy~Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others."
1082967|NCT00607815|O2|Outcome|Present Centered Therapy|"Present Centered Therapy~Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
1082968|NCT00607815|O1|Outcome|Cognitive Processing Therapy|"Cognitive Processing Therapy~Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others."
1082969|NCT00607815|O2|Outcome|Present Centered Therapy|"Present Centered Therapy~Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
1082970|NCT00607815|O1|Outcome|Cognitive Processing Therapy|"Cognitive Processing Therapy~Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others."
1082971|NCT00607815|O2|Outcome|Present Centered Therapy|"Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
1082972|NCT00607815|O1|Outcome|Cognitive Processing Therapy|Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others.
1082973|NCT00607815|E2|Reported Event|Present Centered Therapy|"Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
1082974|NCT00607815|E1|Reported Event|Cognitive Processing Therapy|Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others.
1082975|NCT00607789|B3|Baseline|Total|Total of all reporting groups
1082976|NCT00607789|B2|Baseline|Placebo Group|Participants who were randomized to 30-120 mg/day of sugar pill for 12 weeks
1082977|NCT00607789|B1|Baseline|Duloxetine Group|Participants were randomized to 30-120 mg/day of duloxetine for 12 weeks
1082978|NCT00607789|P2|Participant Flow|Placebo Group|Placebo tablets (identical to duloxetine tablets), 30-120 mg/d given over 12-week period
1082979|NCT00607789|P1|Participant Flow|Duloxetine Group|30-120 mg/day of duloxetine during a 12-week period
1082980|NCT00607789|O2|Outcome|Placebo Group|Participants randomized to 30-120 mg/day of sugar pill for 12 weeks
1082981|NCT00607789|O1|Outcome|Duloxetine Group|Participants randomized to 30-120 mg/day of duloxetine for 12 weeks
1082982|NCT00607789|O2|Outcome|Placebo Group|Participants randomized to 30-120 mg/day of sugar pill for 12 weeks
1082983|NCT00607789|O1|Outcome|Duloxetine Group|Participants randomized to 30-120 mg/day of duloxetine for 12 weeks
1082984|NCT00607789|E2|Reported Event|Placebo Group|Participants randomized to 30-120 mg/day of sugar pill for 12 weeks
1082985|NCT00607789|E1|Reported Event|Duloxetine Group|Participants randomized to 30-120 mg/day of duloxetine for 12 weeks.
1082986|NCT00607724|B8|Baseline|Total|Total of all reporting groups
1082987|NCT00607724|B7|Baseline|Stage 2: New Formulation [GDC-0449 (150 mg )]|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability
1082988|NCT00607724|B6|Baseline|Stage 2:Safety Expansion Cohort [GDC-0449 (150 mg)]|Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
1083095|NCT00607672|O2|Outcome|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
1082989|NCT00607724|B5|Baseline|Stage 2: Basal Cell Carcinoma [GDC-0449 (270 mg)]|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
1082991|NCT00607724|B3|Baseline|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1082992|NCT00607724|B2|Baseline|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1082993|NCT00607724|B1|Baseline|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1082994|NCT00607724|P7|Participant Flow|Stage 2: New Formulation [GDC-0449 (150 mg )]|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
1082995|NCT00607724|P6|Participant Flow|Stage 2:Safety Expansion Cohort [GDC-0449 (150 mg)]|Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
1082996|NCT00607724|P5|Participant Flow|Stage 2: Basal Cell Carcinoma [GDC-0449 (270 mg)]|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
1082997|NCT00607724|P4|Participant Flow|Stage 2: Basal Cell Carcinoma [GDC-0449 (150 mg)]|Participants with basal cell carcinoma (BCC) received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
1082998|NCT00607724|P3|Participant Flow|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1082999|NCT00607724|P2|Participant Flow|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1083000|NCT00607724|P1|Participant Flow|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 milligram (mg) on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression (deterioration of evaluable lesions and/or tumor-related symptoms defined using Response Evaluation Criteria in Solid Tumors Version 1.0 (RECIST v1.0), maximum benefit, or intolerability.
1083001|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1083002|NCT00607724|O2|Outcome|Stage 1+Stage 2: GDC-0449 (270 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 270 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
1083003|NCT00607724|O1|Outcome|Stage 1+Stage 2: GDC-0449 (150 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 150 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
1083004|NCT00607724|O7|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
1083005|NCT00607724|O6|Outcome|Stage 2:Safety Expansion Cohort (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
1083006|NCT00607724|O5|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [270 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
1083007|NCT00607724|O4|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [150 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
1083008|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1083009|NCT00607724|O2|Outcome|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1083010|NCT00607724|O1|Outcome|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1083096|NCT00607672|O1|Outcome|Placebo|Patients are randomized to placebo prior to surgery
1083097|NCT00607672|O3|Outcome|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
1083011|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1083105|NCT00607672|O1|Outcome|Placebo|Patients are randomized to placebo prior to surgery
1083106|NCT00607672|O3|Outcome|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
1083012|NCT00607724|O2|Outcome|Stage 1+Stage 2: GDC-0449 (270 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 270 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
1083013|NCT00607724|O1|Outcome|Stage 1+Stage 2: GDC-0449 (150 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 150 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
1083014|NCT00607724|O7|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
1083015|NCT00607724|O6|Outcome|Stage 2:Safety Expansion Cohort (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
1083016|NCT00607724|O5|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [270 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
1083017|NCT00607724|O4|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [150 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
1083018|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1083019|NCT00607724|O2|Outcome|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1083020|NCT00607724|O1|Outcome|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1083021|NCT00607724|O6|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
1083022|NCT00607724|O5|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [270 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
1083023|NCT00607724|O4|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [150 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
1083024|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1083025|NCT00607724|O2|Outcome|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1083026|NCT00607724|O1|Outcome|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1083027|NCT00607724|O7|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
1083028|NCT00607724|O6|Outcome|Stage 2:Safety Expansion Cohort (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
1083029|NCT00607724|O5|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [270 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
1083030|NCT00607724|O4|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [150 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
1083031|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1083032|NCT00607724|O2|Outcome|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1083033|NCT00607724|O1|Outcome|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1083034|NCT00607724|O1|Outcome|All Participants|Included all participants from Stage 1 and Stage 2.
1085013|NCT00603525|O1|Outcome|Placebo|
1083035|NCT00607724|O1|Outcome|Stage 1: GDC-0449|Included participants with any tumor who received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg, 270 mg and 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, 270 mg and 540 mg orally, continuing until disease progression, maximum benefit, or intolerability.
1083036|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1083037|NCT00607724|O2|Outcome|Stage 1+Stage 2: GDC-0449 (270 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 270 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
1083038|NCT00607724|O1|Outcome|Stage 1+Stage 2: GDC-0449 (150 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 150 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
1083039|NCT00607724|O4|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
1083040|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1083041|NCT00607724|O2|Outcome|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1083042|NCT00607724|O1|Outcome|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1083043|NCT00607724|O4|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
1083044|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1083045|NCT00607724|O2|Outcome|Stage 1+Stage 2: GDC-0449 (270 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 270 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
1083046|NCT00607724|O1|Outcome|Stage 1+Stage 2: GDC-0449 (150 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 150 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
1083047|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1083048|NCT00607724|O2|Outcome|Stage 1+Stage 2: GDC-0449 (270 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 150 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
1083049|NCT00607724|O1|Outcome|Stage 1+Stage 2: GDC-0449 (150 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 150 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
1083050|NCT00607724|O4|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
1083051|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1083052|NCT00607724|O2|Outcome|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1083053|NCT00607724|O1|Outcome|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1083054|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1083055|NCT00607724|O2|Outcome|Stage 1+Stage 2: GDC-0449 (270 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 270 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
1083056|NCT00607724|O1|Outcome|Stage 1+Stage 2: GDC-0449 (150 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 150 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
1083098|NCT00607672|O2|Outcome|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
1083057|NCT00607724|O4|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
1083058|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1083059|NCT00607724|O2|Outcome|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1083060|NCT00607724|O1|Outcome|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1083061|NCT00607724|O7|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received GDC-0449 Phase II drug product as 150-mg hard gelatin capsules daily, orally, starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
1083062|NCT00607724|O6|Outcome|Stage 2:Safety Expansion Cohort (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
1083063|NCT00607724|O5|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [270 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
1083064|NCT00607724|O4|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [150 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
1083065|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1083066|NCT00607724|O2|Outcome|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1083067|NCT00607724|O1|Outcome|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
1083068|NCT00607724|E7|Reported Event|Stage 2: New Formulation [GDC-0449 (150 mg )]|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
1083069|NCT00607724|E6|Reported Event|Stage 2:Safety Expansion Cohort [GDC-0449 (150 mg)]|Participants with tolerable safety, pharmacokinetic and pharmacodynamic data from Stage 1 received daily dose of GDC-0449 hard gelatin capsules at 150 mg on Day 1 until disease progression, maximum benefit, or intolerability.
1083070|NCT00607724|E5|Reported Event|Stage 2: Basal Cell Carcinoma [GDC-0449 (270 mg)]|Participants with basal cell carcinoma (BCC) received daily dose of GDC-0449 hard gelatin capsules at 270 mg on Day 1 until disease progression, maximum benefit, or intolerability.
1083071|NCT00607724|E4|Reported Event|Stage 2: Basal Cell Carcinoma [GDC-0449 (150 mg)]|Participants with basal cell carcinoma (BCC) received daily dose of GDC-0449 hard gelatin capsules at 150 mg on Day 1 until disease progression, maximum benefit, or intolerability.
1083072|NCT00607724|E3|Reported Event|Stage 1: GDC-0449 (540 mg)|Participants received single dose of GDC-0449 hard gelatin capsules at 540 mg on Day 1, thereafter Day 8 received daily dose until disease progression, maximum benefit, or intolerability.
1083073|NCT00607724|E2|Reported Event|Stage 1: GDC-0449 (270 mg)|Stage 1: GDC-0449 (270 mg) Participants received single dose of GDC-0449 hard gelatin capsules at 270 mg on Day 1, thereafter Day 8 received daily dose until disease progression, maximum benefit, or intolerability.
1083074|NCT00607724|E1|Reported Event|Stage 1: GDC-0449 (150 mg)|Participants received single dose of GDC-0449 hard gelatin capsules at 150 mg on Day 1, thereafter Day 8 received daily until disease progression, maximum benefit, or intolerability.
1083075|NCT00607672|B4|Baseline|Total|Total of all reporting groups
1083076|NCT00607672|B3|Baseline|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
1083077|NCT00607672|B2|Baseline|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
1083078|NCT00607672|B1|Baseline|Placebo|Patients are randomized to placebo prior to surgery
1083079|NCT00607672|P3|Participant Flow|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
1083080|NCT00607672|P2|Participant Flow|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
1083081|NCT00607672|P1|Participant Flow|Placebo|Patients are randomized to placebo prior to surgery
1083082|NCT00607672|O3|Outcome|Candesartan (ARB)|Angiotensin receptor blocker group
1083083|NCT00607672|O2|Outcome|Ramipril (ACEI)|Angiotensin-converting enzyme group
1083084|NCT00607672|O1|Outcome|Placebo|Placebo group
1083085|NCT00607672|O3|Outcome|Candesartan (ARB)|Angiotensin receptor blocker group
1083086|NCT00607672|O2|Outcome|Ramipril (ACEI)|Angiotensin-converting enzyme group
1083087|NCT00607672|O1|Outcome|Placebo|Placebo group
1083088|NCT00607672|O3|Outcome|Candesartan (ARB)|Angiotensin receptor blocker group
1083089|NCT00607672|O2|Outcome|Ramipril (ACEI)|Angiotensin-converting enzyme group
1083090|NCT00607672|O1|Outcome|Placebo|Placebo group
1083091|NCT00607672|O3|Outcome|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
1083092|NCT00607672|O2|Outcome|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
1083093|NCT00607672|O1|Outcome|Placebo|Patients are randomized to placebo prior to surgery
1083103|NCT00607672|O3|Outcome|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
1083104|NCT00607672|O2|Outcome|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
1083111|NCT00607672|O1|Outcome|Placebo|Patients are randomized to placebo prior to surgery
1083112|NCT00607672|O3|Outcome|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
1083113|NCT00607672|O2|Outcome|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
1083114|NCT00607672|O1|Outcome|Placebo|Patients are randomized to placebo prior to surgery
1083115|NCT00607672|O3|Outcome|Candesartan (ARB)|Angiotensin receptor blocker group
1083116|NCT00607672|O2|Outcome|Ramipril (ACEI)|Angiotensin-converting enzyme group
1083117|NCT00607672|O1|Outcome|Placebo|Placebo group
1083118|NCT00607672|O3|Outcome|Candesartan (ARB)|Angiotensin receptor blocker group
1083119|NCT00607672|O2|Outcome|Ramipril (ACEI)|Angiotensin-converting enzyme group
1083120|NCT00607672|O1|Outcome|Placebo|Placebo group
1083121|NCT00607672|E3|Reported Event|Candesartan (ARB)|Angiotensin receptor blocker group
1083122|NCT00607672|E2|Reported Event|Ramipril (ACEI)|Angiotensin-converting enzyme group
1083123|NCT00607672|E1|Reported Event|Placebo|Placebo group
1083124|NCT00607594|B1|Baseline|Treatment (Kinase Inhibitor Therapy)|Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.
1083125|NCT00607594|P1|Participant Flow|Treatment (Kinase Inhibitor Therapy)|Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.
1083126|NCT00607594|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|"Patients receive saracatinib PO, at a dose of 175 mg QD in the absence of disease progression or unacceptable toxicity.~saracatinib: Patients receive AZD0530 (saracatinib) PO QD in the absence of disease progression or unacceptable toxicity."
1083127|NCT00607594|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|"Patients receive saracatinib PO, at a dose of 175 mg QD in the absence of disease progression or unacceptable toxicity.~saracatinib: Patients receive AZD0530 (saracatinib) PO QD in the absence of disease progression or unacceptable toxicity."
1083128|NCT00607594|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.
1083129|NCT00607594|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.
1083130|NCT00607594|E1|Reported Event|Treatment (Kinase Inhibitor Therapy)|"Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.~saracatinib~laboratory biomarker analysis: Correlative studies"
1083131|NCT00607477|B3|Baseline|Total|Total of all reporting groups
1083132|NCT00607477|B2|Baseline|Minoxidil|2.5 mg Minoxidil taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week
1083133|NCT00607477|B1|Baseline|Hydralazine|25 mg Hydralazine taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week
1083134|NCT00607477|P2|Participant Flow|Minoxidil|2.5 mg Minoxidil taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week
1083135|NCT00607477|P1|Participant Flow|Hydralazine|25 mg Hydralazine taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week
1083136|NCT00607477|O2|Outcome|Minoxidil|2.5 mg Minoxidil taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week
1083137|NCT00607477|O1|Outcome|Hydralazine|25 mg Hydralazine taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week
1083138|NCT00607477|E2|Reported Event|Minoxidil|2.5 mg Minoxidil taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week
1083139|NCT00607477|E1|Reported Event|Hydralazine|25 mg Hydralazine taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week
1083140|NCT00607386|B1|Baseline|Idursulfase|Open-label treatment with idursulfase
1083141|NCT00607386|P1|Participant Flow|Idursulfase|Open-label treatment with idursulfase
1083142|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
1083143|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
1083144|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
1083145|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
1083146|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
1083147|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
1083148|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
1083149|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
1083150|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
1083151|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
1083152|NCT00607386|E1|Reported Event|Idursulfase|Open-label treatment with idursulfase
1083153|NCT00607373|B3|Baseline|Total|Total of all reporting groups
1083154|NCT00607373|B2|Baseline|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1083155|NCT00607373|B1|Baseline|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
1083156|NCT00607373|P2|Participant Flow|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1083157|NCT00607373|P1|Participant Flow|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
1083158|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1083159|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
1083160|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1083161|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
1083162|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1083163|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
1083164|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1083165|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
1083166|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1083167|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
1083168|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1083169|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
1083170|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1083171|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
1083172|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1083173|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
1083174|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1083175|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
1083176|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1083177|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
1083178|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1083179|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
1083180|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1083181|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
1083182|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1083183|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
1083184|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1083185|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
1083186|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1083187|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
1083188|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1083189|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
1083190|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1083191|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
1083192|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1083193|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
1083194|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1083195|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
1083196|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1083197|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
1083198|NCT00607373|E2|Reported Event|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
1083199|NCT00607373|E1|Reported Event|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
1083200|NCT00607321|B1|Baseline|Medtronic Bifurcation Stent System|Single arm, All patients single de novo bifurcation lesions; 7 run-in subjects not included in analysis
1083201|NCT00607321|P1|Participant Flow|Medtronic Bifurcation Stent System|Single arm, All patients single de novo bifurcation lesions; 7 run-in subjects not included in analysis
1083202|NCT00607321|O1|Outcome|Subjects Receiving Bifurcation Stents|
1083203|NCT00607321|O1|Outcome|Bifurcation Stent System|Evaluable patients within pre-specified follow up window
1083204|NCT00607321|O1|Outcome|Bifurcation Stent System|
1083205|NCT00607321|O1|Outcome|Bifurcation Stent System|
1083206|NCT00607321|O1|Outcome|Subjects Receiving Bifurcation Stents|
1083207|NCT00607321|E1|Reported Event|1. Branch Bifurcation Stent System|All subjects enrolled in the BRANCH study
1083208|NCT00607269|B3|Baseline|Total|Total of all reporting groups
1083289|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083794|NCT00605904|O2|Outcome|Placebo|Subjects received 3 tablets of placebo three times daily
1083209|NCT00607269|B2|Baseline|Contingency Management|Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA < 0.05).
1083210|NCT00607269|B1|Baseline|Control|Control condition receiving minimal incentives for service program attendance and participation.
1083211|NCT00607269|P2|Participant Flow|Contingency Management|Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA < 0.05).
1083843|NCT00605839|P3|Participant Flow|Usual Care|Usual care, without Glucopak or cell phones.
1083212|NCT00607269|P1|Participant Flow|Control|Control condition receiving minimal incentives for service program attendance and participation.
1083213|NCT00607269|O2|Outcome|Contingency Management|Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA < 0.05).
1083214|NCT00607269|O1|Outcome|Control|Control condition receiving minimal incentives for service program attendance and participation.
1083215|NCT00607269|O2|Outcome|Contingency Management|Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA < 0.05).
1083216|NCT00607269|O1|Outcome|Control|Control condition receiving minimal incentives for service program attendance and participation.
1083217|NCT00607269|O2|Outcome|Contingency Management|Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA < 0.05).
1083218|NCT00607269|O1|Outcome|Control|Control condition receiving minimal incentives for service program attendance and participation.
1083219|NCT00607269|O2|Outcome|Contingency Management|Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA < 0.05).
1083220|NCT00607269|O1|Outcome|Control|Control condition receiving minimal incentives for service program attendance and participation.
1083221|NCT00607269|E2|Reported Event|Contingency Management|Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA < 0.05).
1083222|NCT00607269|E1|Reported Event|Control|Control condition receiving minimal incentives for service program attendance and participation.
1083223|NCT00607243|B3|Baseline|Total|Total of all reporting groups
1083224|NCT00607243|B2|Baseline|Low-dose Group|Diluted CJ-50300 2.5 x 10000pfu/dose vaccination
1083225|NCT00607243|B1|Baseline|Conventional-dose Group|Conventional CJ-50300 2.5 x 100000pfu/dose vaccination
1083226|NCT00607243|P2|Participant Flow|Low-dose Group|Diluted CJ-50300 2.5 x 10000pfu/dose vaccination
1083227|NCT00607243|P1|Participant Flow|Conventional-dose Group|Conventional CJ-50300 2.5 x 100000pfu/dose vaccination
1083228|NCT00607243|O2|Outcome|Low-dose Group|Diluted CJ-50300 2.5 x 10000pfu/dose vaccination
1083229|NCT00607243|O1|Outcome|Conventional-dose Group|Conventional CJ-50300 2.5 x 100000pfu/dose vaccination
1083230|NCT00607243|E2|Reported Event|Low-dose Group|Diluted CJ-50300 2.5 x 10000pfu/dose vaccination
1083231|NCT00607243|E1|Reported Event|Conventional-dose Group|Conventional CJ-50300 2.5 x 100000pfu/dose vaccination
1083232|NCT00607126|B3|Baseline|Total|Total of all reporting groups
1083233|NCT00607126|B2|Baseline|Resistive Training|"resistive training using weights and therabands~This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session."
1083234|NCT00607126|B1|Baseline|Lokomat Training Using Body Weight Support on a Treadmill|Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
1083235|NCT00607126|P2|Participant Flow|Resistive Training|"resistive training using weights and therabands~This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session."
1083290|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083291|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083292|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083293|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083839|NCT00605839|B4|Baseline|Total|Total of all reporting groups
1083294|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083295|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083296|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083297|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083298|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083299|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083236|NCT00607126|P1|Participant Flow|Lokomat Training Using Body Weight Support on a Treadmill|Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
1083237|NCT00607126|O2|Outcome|Resistive Training|"resistive training using weights and therabands~This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session."
1083238|NCT00607126|O1|Outcome|Lokomat Training Using Body Weight Support on a Treadmill|Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
1083239|NCT00607126|O2|Outcome|Resistive Training|"resistive training using weights and therabands~This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session."
1083240|NCT00607126|O1|Outcome|Lokomat Training Using Body Weight Support on a Treadmill|Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
1083241|NCT00607126|O2|Outcome|Resistive Training|"resistive training using weights and therabands~This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session."
1083242|NCT00607126|O1|Outcome|Lokomat Training Using Body Weight Support on a Treadmill|Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
1083243|NCT00607126|O2|Outcome|Resistive Training|"resistive training using weights and therabands~This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session."
1083244|NCT00607126|O1|Outcome|Lokomat Training Using Body Weight Support on a Treadmill|Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
1083245|NCT00607126|E2|Reported Event|Resistive Training|"resistive training using weights and therabands~This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session."
1085014|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
1083246|NCT00607126|E1|Reported Event|Lokomat Training Using Body Weight Support on a Treadmill|Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
1083247|NCT00607113|B3|Baseline|Total|Total of all reporting groups
1083248|NCT00607113|B2|Baseline|RAD001|Cycle 1: (First 3 weeks of study) - RAD001 10 mg orally daily for 21 Days, Cycle 2: Avastin 15 mg/kg IV every 3 weeks, RAD001 10 mg orally daily for 3 weeks
1083249|NCT00607113|B1|Baseline|Avastin|Cycle 1: (First 3 weeks of study) - Avastin 15 mg/kg intravenous (IV), Cycle 2: Avastin 15 mg/kg IV every 3 weeks, RAD001 10 mg orally daily for 3 weeks
1083250|NCT00607113|P2|Participant Flow|RAD001|Cycle 1: (First 3 weeks of study) - RAD001 10 mg orally daily for 21 Days, Cycle 2: Avastin 15 mg/kg IV every 3 weeks, RAD001 10 mg orally daily for 3 weeks
1083251|NCT00607113|P1|Participant Flow|Avastin|Cycle 1: (First 3 weeks of study) - Avastin 15 mg/kg intravenous (IV), Cycle 2: Avastin 15 mg/kg IV every 3 weeks, RAD001 10 mg orally daily for 3 weeks
1083252|NCT00607113|O2|Outcome|RAD001|Cycle 1: (First 3 weeks of study) - RAD001 10 mg orally daily for 21 Days, Cycle 2: Avastin 15 mg/kg IV every 3 weeks, RAD001 10 mg orally daily for 3 weeks
1083253|NCT00607113|O1|Outcome|Avastin|Cycle 1 (First 3 weeks of study) - Avastin 15 mg/kg intravenous (IV) or RAD001 10 mg orally daily for 21 Days, Cycle 2: Avastin 15 mg/kg IV every 3 weeks, RAD001 10 mg orally daily for 3 weeks
1083254|NCT00607113|E1|Reported Event|Avastin + RAD001|One agent (RAD001 or Avastin) then adding the second agent (Avastin or RAD001): Avastin 15 mg/kg intravenous (IV) every 3 weeks + RAD001 10 mg orally daily for 21 Days
1083255|NCT00607087|B4|Baseline|Total|Total of all reporting groups
1083256|NCT00607087|B3|Baseline|Sequence 3|insulin lispro / insulin glulisine / insulin aspart
1083257|NCT00607087|B2|Baseline|Sequence 2|insulin aspart / insulin lispro / insulin glulisine
1083258|NCT00607087|B1|Baseline|Sequence 1|insulin glulisine / insulin aspart / insulin lispro
1083259|NCT00607087|P3|Participant Flow|Sequence 3|insulin lispro / insulin glulisine / insulin aspart
1083260|NCT00607087|P2|Participant Flow|Sequence 2|insulin aspart / insulin lispro / insulin glulisine
1083261|NCT00607087|P1|Participant Flow|Sequence 1|insulin glulisine / insulin aspart / insulin lispro
1083262|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083263|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083264|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083265|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083266|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083267|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083268|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083269|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083270|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083271|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083272|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083273|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083274|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083275|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083276|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083277|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083278|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083279|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083280|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083281|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083282|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083283|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083284|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083285|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083286|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083287|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083288|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1085015|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
1083300|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083301|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083302|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083303|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083304|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083305|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083306|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083307|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083308|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083309|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083310|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083311|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083312|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083313|NCT00607087|E3|Reported Event|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083314|NCT00607087|E2|Reported Event|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083315|NCT00607087|E1|Reported Event|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
1083316|NCT00607048|B3|Baseline|Total|Total of all reporting groups
1083317|NCT00607048|B2|Baseline|Schedule B - CP-870893|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort).~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort).~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort)."
1083318|NCT00607048|B1|Baseline|Schedule A - CP-870893|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort).~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort).~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort)."
1083319|NCT00607048|P6|Participant Flow|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort)."
1083320|NCT00607048|P5|Participant Flow|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
1083321|NCT00607048|P4|Participant Flow|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
1083322|NCT00607048|P3|Participant Flow|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort)."
1083323|NCT00607048|P2|Participant Flow|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
1083324|NCT00607048|P1|Participant Flow|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
1083325|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
1083326|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
1083327|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
1083328|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
1083329|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
1083330|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
1083331|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
1083332|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
1083333|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
1083334|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
1083335|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
1083336|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
1083337|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
1083338|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
1083339|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
1083340|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
1085016|NCT00603525|O1|Outcome|Placebo|
1083341|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
1083342|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
1083343|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
1083344|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
1083345|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
1083346|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
1083347|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
1083348|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
1083349|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
1083350|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
1083351|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
1083352|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
1083353|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
1083354|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
1083355|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
1083356|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
1083357|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
1083537|NCT00606632|E1|Reported Event|PET/CT Versus CT|All subjects were scheduled to receive a PET/CT and a diagnostic CT
1083358|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
1083412|NCT00606944|E2|Reported Event|ERP Group|Early rehabilitation program after laparoscopic colon surgery with early oral alimentation and early ambulation
1083359|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
1083360|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
1083361|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
1083362|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
1083363|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
1083364|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
1083365|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
1083366|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
1083367|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
1083368|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
1083369|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
1083370|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
1083371|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
1083372|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
1083373|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
1083389|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
1083374|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
1083413|NCT00606944|E1|Reported Event|Control Group|traditional, conventional care group
1083375|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
1083376|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
1083377|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
1083378|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
1083379|NCT00607048|O2|Outcome|Schedule B - CP-870893|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort). If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort). If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort)."
1083380|NCT00607048|O1|Outcome|Schedule A - CP-870893|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort). If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort). If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort)."
1083381|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
1083382|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
1083383|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
1083384|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
1083385|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
1083386|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
1083387|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
1083388|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
1083414|NCT00606931|B1|Baseline|PET Guided Biopsy|No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
1083415|NCT00606931|P1|Participant Flow|PET Guided Biopsy|No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
1083416|NCT00606931|O1|Outcome|PET Guided Biopsy|No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
1083390|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
1083391|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
1083392|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
1083393|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
1083394|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
1083395|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
1083396|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
1083397|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
1083398|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
1083399|NCT00607048|E6|Reported Event|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort)."
1083400|NCT00607048|E5|Reported Event|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
1083401|NCT00607048|E4|Reported Event|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
1083402|NCT00607048|E3|Reported Event|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort)."
1083403|NCT00607048|E2|Reported Event|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
1083404|NCT00607048|E1|Reported Event|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
1083405|NCT00606944|B3|Baseline|Total|Total of all reporting groups
1083406|NCT00606944|B2|Baseline|ERP Group|Early rehabilitation program after laparoscopic colon surgery with early oral alimentation and early ambulation
1083407|NCT00606944|B1|Baseline|Control Group|traditional, conventional care group
1083408|NCT00606944|P2|Participant Flow|ERP Group|Early rehabilitation program after laparoscopic colorectal surgery with early oral alimentation and early ambulation
1083409|NCT00606944|P1|Participant Flow|Control Group|traditional, conventional care group
1083410|NCT00606944|O2|Outcome|ERP Group|Early rehabilitation program after laparoscopic colorectal surgery with early oral alimentation and early ambulation
1083417|NCT00606931|O1|Outcome|PET Guided Biopsy|No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
1083418|NCT00606931|O1|Outcome|PET Guided Biopsy|No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
1083419|NCT00606931|E1|Reported Event|PET Guided Biopsy|No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
1083420|NCT00606905|B3|Baseline|Total|Total of all reporting groups
1083421|NCT00606905|B2|Baseline|Normal Saline|equivalent volume of normal saline
1083422|NCT00606905|B1|Baseline|IVIG|IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution. 500 mg/kg adminstered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.
1083423|NCT00606905|P2|Participant Flow|Normal Saline|equivalent volume of normal saline
1083424|NCT00606905|P1|Participant Flow|IVIG|IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution. 500 mg/kg adminstered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.
1083425|NCT00606905|O2|Outcome|Normal Saline|equivalent volume of normal saline
1083426|NCT00606905|O1|Outcome|IVIG|IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution. 500 mg/kg adminstered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.
1083427|NCT00606905|E2|Reported Event|Normal Saline|equivalent volume of normal saline
1083428|NCT00606905|E1|Reported Event|IVIG|IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution. 500 mg/kg adminstered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.
1083429|NCT00606892|B1|Baseline|Entire Study Population|Includes all subjects who completed the study. (The total number of subjects who were enrolled in both arms of the study.)
1083430|NCT00606892|P2|Participant Flow|Varenicline First, Then Placebo|Subjects received Varenicline (1mg) per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, and 0.7mg per 70kg).After a minimum of washout period of 5 days, then subjects received a placebo tablet once per day for 4 days and then received a laboratory session where they were given ascending dose of Nicotine (0.1,0.4, and 0.7mg per70kg).
1083431|NCT00606892|P1|Participant Flow|Placebo First, Then Varenicline|Subject received a placebo tablet once per day for 4 days and then received a laboratory session where they were given ascending dose of Nicotine (0.1,0.4, and 0.7mg per70kg). After a minimum washout period of 5 days,then subjects received Varenicline (1mg) per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, and 0.7mg per 70kg).
1083432|NCT00606892|O6|Outcome|Varenicline / High Dose Nicotine|The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.7mg per 70kg) infusion under the varenicline condition.
1083433|NCT00606892|O5|Outcome|Varenicline/ Medium Dose Nicotine|The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.4mg per 70kg) infusion under the varenicline condition.
1083434|NCT00606892|O4|Outcome|Varenicline/ Low Dose Nicotine|The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.1mg per 70kg) infusion under the varenicline condition.
1083435|NCT00606892|O3|Outcome|Placebo/High Dose Nicotine|The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.7mg per 70kg) infusion under the placebo condition.
1083436|NCT00606892|O2|Outcome|Placebo/ Medium Dose Nicotine|The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.4mg per 70kg) infusion under the placebo condition.
1083437|NCT00606892|O1|Outcome|Placebo / Low Dose Nicotine|The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.1mg per 70kg) infusion under the placebo condition.
1083438|NCT00606892|O6|Outcome|Varenicline / High Dose Nicotine|The average peak change (change score) in heart rate after nicotine (0.7mg per 70kg) infusion under the varenicline condition.
1083439|NCT00606892|O5|Outcome|Varenicline/ Medium Dose Nicotine|The average peak change (change score) in heart rate after nicotine (0.4mg per 70kg) infusion under the varenicline condition.
1083440|NCT00606892|O4|Outcome|Varenicline/ Low Dose Nicotine|The average peak change (change score) in heart rate after nicotine (0.1mg per 70kg) infusion under the varenicline condition.
1083441|NCT00606892|O3|Outcome|Placebo/High Dose Nicotine|The average peak change (change score) in heart rate after nicotine (0.7mg per 70kg) infusion under the placebo condition.
1083442|NCT00606892|O2|Outcome|Placebo/ Medium Dose Nicotine|The average peak change (change score) in heart rate after nicotine (0.4mg per 70kg) infusion under the placebo condition.
1083443|NCT00606892|O1|Outcome|Placebo / Low Dose Nicotine|The average peak change (change score) in heart rate after nicotine (0.1mg per70kg) infusion under the placebo condition.
1083444|NCT00606892|O6|Outcome|Varenicline/ High Dose Nicotine|The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the high dose (0.7) of IV nicotine under the varenicline condition.
1083445|NCT00606892|O5|Outcome|Varenicline/ Medium Dose Nicotine|The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the medium dose (0.4) of IV nicotine under the varenicline condition.
1083446|NCT00606892|O4|Outcome|Varenicline/ Low Dose Nicotine|The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the low dose (0.1) of IV nicotine under the varenicline condition.
1083447|NCT00606892|O3|Outcome|Placebo/High Dose Nicotine|The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the high dose (0.7) of IV nicotine under the placebo condition.
1083448|NCT00606892|O2|Outcome|Placebo/ Medium Dose Nicotine|The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the medium dose (0.4) of IV nicotine under the placebo condition.
1083449|NCT00606892|O1|Outcome|Placebo/ Low Dose Nictoine|The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the low dose (0.1) of IV nicotine under the placebo condition.
1083450|NCT00606892|O2|Outcome|Varenicline (1 mg)|The mean cotinine levels for subjects under the varenicline condition.
1083451|NCT00606892|O1|Outcome|Placebo|The mean cotinine levels for subjects under the placebo condition.
1083452|NCT00606892|O4|Outcome|Varenicline, Post-Nicotine|Mean reaction time during modified Stroop task under the varenicline condition and 30 minutes after the nicotine infusions.
1083453|NCT00606892|O3|Outcome|Varenicline, Pre-Nicotine|Mean reaction time during modified Stroop task under the varenicline condition prior to the nicotine infusions.
1083454|NCT00606892|O2|Outcome|Placebo, Post-Nicotine|Mean reaction time during modified Stroop task under the placebo condition and 30 minutes after the nicotine infusions.
1083455|NCT00606892|O1|Outcome|Placebo, Pre-Nicotine|Mean reaction time during modified Stroop task under the placebo condition and prior to the nicotine infusions.
1083456|NCT00606892|E6|Reported Event|Varenicline First, Then Placebo, Second Intervention|Subjects crossed-over from the first intervention (varenicline) and received placebo once per day for 4 days prior to the second laboratory session (second intervention) where they were given ascending doses of Nicotine (0.1, 0.7mg per 70kg).
1083457|NCT00606892|E5|Reported Event|Placebo First, Then Varenicline, Second Intervention|Subjects crossed-over from the first intervention and received varenicline once per day for 4 days prior to the second laboratory session (second intervention) where they were given ascending doses of Nicotine (0.1, 0.7mg per 70kg).
1083458|NCT00606892|E4|Reported Event|Adaptation - Varenicline First, Then Placebo|Subjects randomized to the 'Varenicline first' condition first received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, 0.7mg per 70 kg) to assess tolerability before receiving the study medication.
1083459|NCT00606892|E3|Reported Event|Adaptation - Placebo First, Then Varenicline|Subjects randomized to the 'Placebo first' condition participated in a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, 0.7mg per 70 kg) to assess tolerability prior to the study medication intervention.
1083460|NCT00606892|E2|Reported Event|Varenicline First, Then Placebo, First Intervention|Subjects received varenicline once per day for 4 days prior to the first laboratory session (first intervention) where they were given ascending doses of Nicotine (0.1, 0.7mg per 70kg).
1083461|NCT00606892|E1|Reported Event|Placebo First, Then Varenicline, First Intervention|Subjects received a placebo tablet once per day for 4 days prior to the first laboratory session (first intervention) where they were given ascending doses of Nicotine (0.1, 0.7mg per 70kg).
1083462|NCT00606801|B3|Baseline|Total|Total of all reporting groups
1083463|NCT00606801|B2|Baseline|Placebo|Placebo given for 10 days.
1083464|NCT00606801|B1|Baseline|Galantamine 8 mg/Day|Galantamine 8 mg/day given for 10 days.
1083465|NCT00606801|P2|Participant Flow|Galantamine 8 mg/Day|Galantamine 8 mg/day given for 10 days.
1083466|NCT00606801|P1|Participant Flow|Placebo|Placebo given for 10 days.
1083467|NCT00606801|O6|Outcome|Galantamine - Day 10|Measures in galantamine group on Day 10 of medication administration.
1083468|NCT00606801|O5|Outcome|Galantamine - Day 5|Measures in galantamine group on Day 5 of medication administration.
1083469|NCT00606801|O4|Outcome|Galantamine - Baseline|Measures in galantamine group prior to medication administration.
1083470|NCT00606801|O3|Outcome|Placebo - Day 10|Measures in placebo group on Day 10 of medication administration.
1083471|NCT00606801|O2|Outcome|Placebo - Day 5|Measures in placebo group on Day 5 of medication administration.
1083472|NCT00606801|O1|Outcome|Placebo - Baseline|Measures in placebo group prior to medication administration.
1083473|NCT00606801|O6|Outcome|Galantamine - Day 10|Measures in galantamine group on Day 10 of medication administration.
1083474|NCT00606801|O5|Outcome|Galantamine - Day 5|Measures in galantamine group on Day 5 of medication administration.
1083475|NCT00606801|O4|Outcome|Galantamine - Baseline|Measures in galantamine group prior to medication administration.
1083476|NCT00606801|O3|Outcome|Placebo - Day 10|Measures in placebo group on Day 10 of medication administration.
1083477|NCT00606801|O2|Outcome|Placebo - Day 5|Measures in placebo group on Day 5 of medication administration.
1083478|NCT00606801|O1|Outcome|Placebo - Baseline|Measures in placebo group prior to medication administration.
1083479|NCT00606801|O6|Outcome|Galantamine - Day 10|Measures in galantamine group on Day 10 of medication administration.
1083480|NCT00606801|O5|Outcome|Galantamine - Day 5|Measures in galantamine group on Day 5 of medication administration.
1083481|NCT00606801|O4|Outcome|Galantamine - Baseline|Measures in galantamine group prior to medication administration.
1083482|NCT00606801|O3|Outcome|Placebo - Day 10|Measures in placebo group on Day 10 of medication administration.
1083483|NCT00606801|O2|Outcome|Placebo - Day 5|Measures in placebo group on Day 5 of medication administration.
1083484|NCT00606801|O1|Outcome|Placebo - Baseline|Measures prior to medication administration.
1083485|NCT00606801|E2|Reported Event|Placebo|Placebo given for 10 days.
1083486|NCT00606801|E1|Reported Event|Galantamine 8 mg/Day|Galantamine 8 mg/day given for 10 days.
1083487|NCT00606684|B7|Baseline|Total|Total of all reporting groups
1083488|NCT00606684|B6|Baseline|GW642444M 50 µg OD|Participants received GW642444M 50 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083489|NCT00606684|B5|Baseline|GW642444M 25 µg OD|Participants received GW642444M 25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083660|NCT00606281|O2|Outcome|Placebo|Subjects were administered placebo once daily for 21 days.
1083490|NCT00606684|B4|Baseline|GW642444M 12.5 µg OD|Participants received GW642444M 12.5 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083491|NCT00606684|B3|Baseline|GW642444M 6.25 µg OD|Participants received GW642444M 6.25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083492|NCT00606684|B2|Baseline|GW642444M 3 µg OD|Participants received GW642444M 3 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083493|NCT00606684|B1|Baseline|Placebo|Participants received placebo (1 actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083494|NCT00606684|P7|Participant Flow|GW642444M 50 µg|Participants received GW642444M 50 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083495|NCT00606684|P6|Participant Flow|GW642444M 25 µg|Participants received GW642444M 25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083496|NCT00606684|P5|Participant Flow|GW642444M 12.5 µg|Participants received GW642444M 12.5 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083497|NCT00606684|P4|Participant Flow|GW642444M 6.25 µg|Participants received GW642444M 6.25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083498|NCT00606684|P3|Participant Flow|GW642444M 3 µg|Participants received GW642444M 3 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083499|NCT00606684|P2|Participant Flow|Placebo|Participants received placebo (1 actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083500|NCT00606684|P1|Participant Flow|Placebo Run-in|Participants received placebo once daily (OD) in the morning from the novel dual strip dry powder inhaler. In addition, all participants were provided supplemental albuterol (salbutamol) (metered dose inhaler [MDI] and/or nebules) to be used asneeded throughout the study.
1083501|NCT00606684|O6|Outcome|GW642444M 50 µg OD|Participants received GW642444M 50 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083502|NCT00606684|O5|Outcome|GW642444M 25 µg OD|Participants received GW642444M 25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083503|NCT00606684|O4|Outcome|GW642444M 12.5 µg OD|Participants received GW642444M 12.5 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083504|NCT00606684|O3|Outcome|GW642444M 6.25 µg OD|Participants received GW642444M 6.25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083505|NCT00606684|O2|Outcome|GW642444M 3 µg OD|Participants received GW642444M 3 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083506|NCT00606684|O1|Outcome|Placebo|Participants received placebo (1 actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083507|NCT00606684|O6|Outcome|GW642444M 50 µg OD|Participants received GW642444M 50 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083508|NCT00606684|O5|Outcome|GW642444M 25 µg OD|Participants received GW642444M 25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083509|NCT00606684|O4|Outcome|GW642444M 12.5 µg OD|Participants received GW642444M 12.5 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083510|NCT00606684|O3|Outcome|GW642444M 6.25 µg OD|Participants received GW642444M 6.25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083511|NCT00606684|O2|Outcome|GW642444M 3 µg OD|Participants received GW642444M 3 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083512|NCT00606684|O1|Outcome|Placebo|Participants received placebo (1 actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083513|NCT00606684|O6|Outcome|GW642444M 50 µg OD|Participants received GW642444M 50 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083514|NCT00606684|O5|Outcome|GW642444M 25 µg OD|Participants received GW642444M 25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083515|NCT00606684|O4|Outcome|GW642444M 12.5 µg OD|Participants received GW642444M 12.5 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083516|NCT00606684|O3|Outcome|GW642444M 6.25 µg OD|Participants received GW642444M 6.25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083517|NCT00606684|O2|Outcome|GW642444M 3 µg OD|Participants received GW642444M 3 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083518|NCT00606684|O1|Outcome|Placebo|Participants received placebo (1 actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083519|NCT00606684|O6|Outcome|GW642444M 50 µg OD|Participants received GW642444M 50 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083520|NCT00606684|O5|Outcome|GW642444M 25 µg OD|Participants received GW642444M 25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083521|NCT00606684|O4|Outcome|GW642444M 12.5 µg OD|Participants received GW642444M 12.5 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083522|NCT00606684|O3|Outcome|GW642444M 6.25 µg OD|Participants received GW642444M 6.25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083523|NCT00606684|O2|Outcome|GW642444M 3 µg OD|Participants received GW642444M 3 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083524|NCT00606684|O1|Outcome|Placebo|Participants received placebo (1 actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083525|NCT00606684|E6|Reported Event|GW642444M 50 µg OD|Participants received GW642444M 50 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083526|NCT00606684|E5|Reported Event|GW642444M 25 µg OD|Participants received GW642444M 25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083527|NCT00606684|E4|Reported Event|GW642444M 12.5 µg OD|Participants received GW642444M 12.5 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083528|NCT00606684|E3|Reported Event|GW642444M 6.25 µg OD|Participants received GW642444M 6.25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083529|NCT00606684|E2|Reported Event|GW642444M 3 µg OD|Participants received GW642444M 3 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083530|NCT00606684|E1|Reported Event|Placebo|Participants received placebo (1 actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
1083531|NCT00606632|B1|Baseline|PET/CT Versus CT|All subjects were scheduled to receive a PET/CT and a diagnostic CT
1083532|NCT00606632|P1|Participant Flow|PET/CT Versus CT|PET/CT and CT scans for all study subjects 4 days (+/- 2 days) after 124I cG250 administration.
1083533|NCT00606632|O4|Outcome|Specificity CT|"Specificity of CT scan for proportion of patients with negative histology (no ccRCC) and evaluable images.~The specificity refers to the ability of the diagnostic test to correctly identify those patients without the disease (in this case non-ccRCC)."
1083534|NCT00606632|O3|Outcome|Specificity PET/CT|"Specificity of PET/CT scan for proportion of patients with negative histology (no ccRCC) and evaluable images.~The specificity of refers to the ability of the diagnostic test to correctly identify those patients without the disease (in this case non-ccRCC)."
1083535|NCT00606632|O2|Outcome|Sensitivity CT|"Sensitivity of diagnostic CT scan for proportion of patients with positive histology (ccRCC) and evaluable images.~The sensitivity refers to the ability of the diagnostic test to correctly identify those patients with the disease, in this case ccRCC."
1083536|NCT00606632|O1|Outcome|Sensitivity PET/CT|"Sensitivity of 124I-cG250 PET/CT scan for proportion of patients with positive histology (ccRCC) and evaluable images.~The sensitivity refers to the ability of the diagnostic test to correctly identify those patients with the disease, in this case ccRCC."
1083840|NCT00605839|B3|Baseline|Usual Care|Usual care, without cell phone or glucopak
1083538|NCT00606593|B1|Baseline|Patient Flow|The study consisted of a 2-4-week screening phase (including 2 consecutive screening polysomnography (PSG) nights on single blind placebo), a 4- to 8-week treatment phase, and a 28 day safety follow-up. The treatment phase immediately followed randomization and included 5 treatment periods, each consisting of 2 consecutive treatment PSG nights on the assigned study treatment separated by 5 to 12 days of washout. Subjects were randomized to one of 10 treatment sequences.
1083564|NCT00606593|E1|Reported Event|Single-blind Placebo|Treatment administered during screening period
1083539|NCT00606593|P10|Participant Flow|Treatment Sequence 50/100/25/200/P|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 50 mg/ACT-078573 100 mg/ACT-078573 25 mg/ACT-078573 200 mg/placebo.
1083540|NCT00606593|P9|Participant Flow|Treatment Sequence 100/200/50/P/25|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 100 mg/ACT-078573 200 mg/ACT-078573 50 mg/placebo/ACT-078573 25 mg.
1083541|NCT00606593|P8|Participant Flow|Treatment Sequence 200/P/100/25/50|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 200 mg/placebo/ACT-078573 100 mg/ACT-078573 25 mg/ACT-078573 50 mg.
1083542|NCT00606593|P7|Participant Flow|Treatment Sequence P/25/200/50/100|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: placebo/ACT-078573 25 mg/ACT-078573 200 mg/ACT-078573 50 mg/ACT-078573 100 mg.
1083543|NCT00606593|P6|Participant Flow|Treatment Sequence 25/50/P/100/200|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 25 mg/ACT-078573 50 mg/placebo/ACT-078573 100 mg/ACT-078573 200 mg.
1083544|NCT00606593|P5|Participant Flow|Treatment Sequence P/200/25/100/50|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: placebo/ACT-078573 200 mg/ACT-078573 25 mg/ACT-078573 100 mg/ACT-078573 50 mg.
1083545|NCT00606593|P4|Participant Flow|Treatment Sequence 25/P/50/200/100|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 25 mg/placebo/ACT-078573 50 mg/ACT-078573 200 mg/ACT-078573 100 mg.
1083546|NCT00606593|P3|Participant Flow|Treatment Sequence 50/25/100/P/200|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 50 mg/ACT-078573 25 mg/ACT-078573 100 mg/placebo/ACT-078573 200 mg.
1083547|NCT00606593|P2|Participant Flow|Treatment Sequence 100/50/200/25/P|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 100 mg/ACT-078573 50 mg/ACT-078573 200 mg/ACT-078573 25 mg/placebo.
1083548|NCT00606593|P1|Participant Flow|Treatment Sequence 200/100/P/50/25|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: almorexant (ACT-078573) 200 mg/ACT-078573 100 mg/Placebo/ACT-078573 50 mg/ACT-078573 25mg.
1083549|NCT00606593|O5|Outcome|ACT-078573 200 mg|Two capsules containing ACT-078573 200 mg, orally administered on each of 2 consecutive nights
1083550|NCT00606593|O4|Outcome|ACT-078573 100 mg|Two capsules containing ACT-078573 100 mg, orally administered on each of 2 consecutive nights
1083551|NCT00606593|O3|Outcome|ACT-078573 50 mg|Two capsules containing ACT-078573 50 mg, orally administered on each of 2 consecutive nights
1083552|NCT00606593|O2|Outcome|ACT-078573 25 mg|Two capsules containing ACT-078573 25 mg, orally administered on each of 2 consecutive nights
1083553|NCT00606593|O1|Outcome|Placebo|Two capsules containing placebo, orally administered on each of 2 consecutive nights
1083554|NCT00606593|O5|Outcome|ACT-078573 200 mg|Two capsules containing ACT-078573 200 mg, orally administered on each of 2 consecutive nights
1083555|NCT00606593|O4|Outcome|ACT-078573 100 mg|Two capsules containing ACT-078573 100 mg, orally administered on each of 2 consecutive nights
1083556|NCT00606593|O3|Outcome|ACT-078573 50 mg|Two capsules containing ACT-078573 50 mg, orally administered on each of 2 consecutive nights
1083557|NCT00606593|O2|Outcome|ACT-078573 25 mg|Two capsules containing ACT-078573 25 mg, orally administered on each of 2 consecutive nights
1083558|NCT00606593|O1|Outcome|Placebo|Two capsules containing placebo, orally administered on each of 2 consecutive nights
1083559|NCT00606593|E6|Reported Event|ACT-078573 200 mg|Two capsules containing ACT-078573 200 mg, orally administered on each of 2 consecutive nights
1083560|NCT00606593|E5|Reported Event|ACT-078573 100 mg|Two capsules containing ACT-078573 100 mg, orally administered on each of 2 consecutive nights
1083793|NCT00605904|O1|Outcome|Acamprosate|Subjects received 3 tablets of 333mg acamprosate three times daily
1083561|NCT00606593|E4|Reported Event|ACT-078573 50 mg|Two capsules containing ACT-078573 50 mg, orally administered on each of 2 consecutive nights
1083562|NCT00606593|E3|Reported Event|ACT-078573 25 mg|Two capsules containing ACT-078573 25 mg, orally administered on each of 2 consecutive nights
1083563|NCT00606593|E2|Reported Event|Placebo|Two capsules containing placebo, orally administered on each of 2 consecutive nights
1083566|NCT00606580|B3|Baseline|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
1083567|NCT00606580|B2|Baseline|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
1083568|NCT00606580|B1|Baseline|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
1083569|NCT00606580|P3|Participant Flow|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
1083570|NCT00606580|P2|Participant Flow|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
1083571|NCT00606580|P1|Participant Flow|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
1083572|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
1083573|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
1083574|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
1083575|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
1083576|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
1083577|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
1083578|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
1083579|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
1083580|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
1083581|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
1083582|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
1083583|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
1083584|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
1083585|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
1083586|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
1083587|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
1083588|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
1083589|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
1083590|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
1083591|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
1083592|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
1083593|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
1083594|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
1083595|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
1083596|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
1083597|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
1083598|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
1083599|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
1083600|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
1083601|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
1083602|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
1083603|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
1083604|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
1083605|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
1083606|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
1083607|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
1083608|NCT00606580|E3|Reported Event|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
1083609|NCT00606580|E2|Reported Event|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
1085017|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
1083610|NCT00606580|E1|Reported Event|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
1083611|NCT00606554|B3|Baseline|Total|Total of all reporting groups
1083612|NCT00606554|B2|Baseline|Standard of Care|"Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.~Comparator group"
1083613|NCT00606554|B1|Baseline|Computer-assisted Wean|Group assigned to the computer-assisted weaning program Intervention Group
1083614|NCT00606554|P2|Participant Flow|Standard of Care|"Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.~Comparator group"
1083615|NCT00606554|P1|Participant Flow|Computer-assisted Wean|Group assigned to the computer-assisted weaning program Intervention Group
1083616|NCT00606554|O2|Outcome|Standard of Care|"Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.~Comparator group"
1083617|NCT00606554|O1|Outcome|Computer-assisted Wean|Group assigned to the computer-assisted weaning program Intervention Group
1083618|NCT00606554|O2|Outcome|Standard of Care Weaning|comparator arm
1083619|NCT00606554|O1|Outcome|Computer-assisted Weaning|intervention arm
1083620|NCT00606554|O2|Outcome|Standard of Care|"Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.~Comparator group"
1083621|NCT00606554|O1|Outcome|Computer-assisted Wean|Group assigned to the computer-assisted weaning program Intervention Group
1083622|NCT00606554|E2|Reported Event|Standard of Care|"Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.~Comparator group"
1083623|NCT00606554|E1|Reported Event|Computer-assisted Wean|Group assigned to the computer-assisted weaning program Intervention Group
1083624|NCT00606502|B3|Baseline|Total|Total of all reporting groups
1083625|NCT00606502|B2|Baseline|Erlotinib|
1083626|NCT00606502|B1|Baseline|Pralatrexate|
1083627|NCT00606502|P2|Participant Flow|Erlotinib|150 mg tablet taken orally daily
1083628|NCT00606502|P1|Participant Flow|Pralatrexate|190 or 230 mg/m2 starting dose with increases or decreases to 150 to 270 mg/m2 per protocol, administered as an IV push over 3-5 minutes on days 1 and 15 of a 4-week cycle (ie, every 2 weeks)
1083629|NCT00606502|O2|Outcome|Erlotinib|
1083630|NCT00606502|O1|Outcome|Pralatrexate|
1083631|NCT00606502|O2|Outcome|Erlotinib|
1083632|NCT00606502|O1|Outcome|Pralatrexate|
1083633|NCT00606502|O2|Outcome|Erlotinib|
1083634|NCT00606502|O1|Outcome|Pralatrexate|
1083635|NCT00606502|O2|Outcome|Erlotinib|
1083636|NCT00606502|O1|Outcome|Pralatrexate|
1083637|NCT00606502|E2|Reported Event|Erlotinib|
1083638|NCT00606502|E1|Reported Event|Pralatrexate|
1083639|NCT00606489|B3|Baseline|Total|Total of all reporting groups
1083640|NCT00606489|B2|Baseline|800mg Intravenous Ibuprofen|
1083641|NCT00606489|B1|Baseline|Placebo (250 Milliliters Normal Saline)|
1083642|NCT00606489|P2|Participant Flow|800mg Intravenous Ibuprofen|
1083643|NCT00606489|P1|Participant Flow|Placebo (250 Milliliters Normal Saline)|
1083644|NCT00606489|O2|Outcome|800mg Intravenous Ibuprofen|
1083645|NCT00606489|O1|Outcome|Placebo (250 Milliliters Normal Saline)|
1083646|NCT00606489|E2|Reported Event|800mg Intravenous Ibuprofen|
1083647|NCT00606489|E1|Reported Event|Placebo (250 Milliliters Normal Saline)|
1083648|NCT00606320|B1|Baseline|Arupiprazole|"Patients who had completed the preceding study but whose condition worsened or remained unchanged or who discontinued the preceding study on Day 14 to Day 21 due to lack of drug efficacy were the target.~Subjects were administered 24, 12, or 30mg/day of aripiprazole once daily for 154 days in an unblinded manner. Subjects were also administered mood stabilizer concomitantly for 154 days."
1083649|NCT00606320|P1|Participant Flow|Aripiprazple|"Patients who had completed the preceding study but whose condition worsened or remained unchanged or who discontinued the preceding study on Day 14 to Day 21 due to lack of drug efficacy were the target.~Subjects were administered 24, 12, or 30mg/day of aripiprazole once daily for 154 days in an unblinded manner. Subjects were also administered mood stabilizer concomitantly for 154 days."
1083650|NCT00606320|O1|Outcome|Aripiprazple|"Patients who had completed the preceding study but whose condition worsened or remained unchanged or who discontinued the preceding study on Day 14 to Day 21 due to lack of drug efficacy were the target.~Subjects were administered 24, 12, or 30mg/day of aripiprazole once daily for 154 days in an unblinded manner. Subjects were also administered mood stabilizer concomitantly for 154 days."
1083651|NCT00606320|O1|Outcome|Aripiprazple|"Patients who had completed the preceding study but whose condition worsened or remained unchanged or who discontinued the preceding study on Day 14 to Day 21 due to lack of drug efficacy were the target.~Subjects were administered 24, 12, or 30mg/day of aripiprazole once daily for 154 days in an unblinded manner. Subjects were also administered mood stabilizer concomitantly for 154 days."
1083652|NCT00606320|E1|Reported Event|Aripiprazole|Patients who had completed the preceding study but whose condition worsened or remained unchanged or who discontinued the preceding study on Day 14 to Day 21 due to lack of drug efficacy were the target.
1083653|NCT00606281|B3|Baseline|Total|Total of all reporting groups
1083654|NCT00606281|B2|Baseline|Placebo|Subjects were administered placebo once daily for 21 days.
1083655|NCT00606281|B1|Baseline|Aripiprazole|Subjects were administered 24 mg/day of aripiprazole once daily for 21 days. If there was a problem with tolerability, the dose could be reduced to 12 mg/day.
1083656|NCT00606281|P2|Participant Flow|Placebo|Subjects were administered placebo once daily for 21 days.
1083657|NCT00606281|P1|Participant Flow|Aripiprazole|Subjects were administered 24 mg/day of aripiprazole once daily for 21 days. If there was a problem with tolerability, the dose could be reduced to 12 mg/day.
1083658|NCT00606281|O2|Outcome|Placebo|Subjects were administered placebo once daily for 21 days.
1083659|NCT00606281|O1|Outcome|Aripiprazole|Subjects were administered 24 mg/day of aripiprazole once daily for 21 days. If there was a problem with tolerability, the dose could be reduced to 12 mg/day.
1083661|NCT00606281|O1|Outcome|Aripiprazole|Subjects were administered 24 mg/day of aripiprazole once daily for 21 days. If there was a problem with tolerability, the dose could be reduced to 12 mg/day.
1083662|NCT00606281|E2|Reported Event|Placebo|Subjects were administered placebo once daily for 21 days.
1083663|NCT00606281|E1|Reported Event|Aripiprazole|Subjects were administered 24 mg/day of aripiprazole once daily for 21 days. If there was a problem with tolerability, the dose could be reduced to 12 mg/day.
1083664|NCT00606229|B1|Baseline|Aripiprazole|Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets).
1083665|NCT00606229|P1|Participant Flow|Aripiprazole|Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets).
1083666|NCT00606229|O1|Outcome|Aripiprazole|Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets).
1083667|NCT00606229|O1|Outcome|Aripiprazole|Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets).
1083668|NCT00606229|E1|Reported Event|Aripiprazole|Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets).
1083669|NCT00606177|B3|Baseline|Total|Total of all reporting groups
1083670|NCT00606177|B2|Baseline|Placebo|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered placebo once daily for 154 days."
1083671|NCT00606177|B1|Baseline|Aripiprazole|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered 24 ,12, or 30 mg/day of aripiprazole once daily for 154 days."
1083672|NCT00606177|P2|Participant Flow|Placebo|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered placebo once daily for 154 days."
1083673|NCT00606177|P1|Participant Flow|Aripiprazole|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered 24 ,12, or 30 mg/day of aripiprazole once daily for 154 days."
1083674|NCT00606177|O2|Outcome|Placebo|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered placebo once daily for 154 days."
1083675|NCT00606177|O1|Outcome|Aripiprazole|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered 24 ,12, or 30 mg/day of aripiprazole once daily for 154 days."
1083676|NCT00606177|O2|Outcome|Placebo|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered placebo once daily for 154 days."
1083677|NCT00606177|O1|Outcome|Aripiprazole|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered 24 ,12, or 30 mg/day of aripiprazole once daily for 154 days."
1083678|NCT00606177|E2|Reported Event|Placebo|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered placebo once daily for 154 days."
1083679|NCT00606177|E1|Reported Event|Aripiprazole|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered 24 ,12, or 30 mg/day of aripiprazole once daily for 154 days."
1083680|NCT00606138|B3|Baseline|Total|Total of all reporting groups
1083681|NCT00606138|B2|Baseline|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
1083682|NCT00606138|B1|Baseline|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
1083683|NCT00606138|P2|Participant Flow|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
1083684|NCT00606138|P1|Participant Flow|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
1083685|NCT00606138|O2|Outcome|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
1083686|NCT00606138|O1|Outcome|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
1083687|NCT00606138|O2|Outcome|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
1083688|NCT00606138|O1|Outcome|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
1083689|NCT00606138|O2|Outcome|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
1083690|NCT00606138|O1|Outcome|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
1083691|NCT00606138|O2|Outcome|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
1083692|NCT00606138|O1|Outcome|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
1083693|NCT00606138|O2|Outcome|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
1083694|NCT00606138|O1|Outcome|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
1083695|NCT00606138|E2|Reported Event|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
1083696|NCT00606138|E1|Reported Event|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
1083697|NCT00606086|B3|Baseline|Total|Total of all reporting groups
1083698|NCT00606086|B2|Baseline|Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005|Subjects were treated with 12 weeks of SOC (Peg-IFN plus Ribavirin) therapy. Subjects who achieve an EVR continued to receive SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR, GI-5005 was added to SOC therapy and study drug administration continued for up to an additional 62 weeks. Subjects who discontinued SOC therapy due to intolerance were treated with GI-5005 monotherapy for up to 72 weeks.
1083718|NCT00606021|O2|Outcome|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
1085018|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
1083719|NCT00606021|O1|Outcome|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles~Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
1083720|NCT00606021|O3|Outcome|Pemetrexed Plus Cisplatin (Induction Phase)|Pemetrexed, 500 milligrams per square meter (mg/m²), intravenous (IV) followed by Cisplatin, IV, 75 mg/m² on Day 1 of each 21-day cycle for 4 cycles
1083699|NCT00606086|B1|Baseline|Arm 1: Peg-IFN/Ribavirin Plus GI-5005|Subjects were given GI-5005 alone for 12 weeks (5 weekly followed by 2 monthly doses). After completion of GI-5005 monotherapy run in period peg-IFN/ribavirin (SOC) therapy was added to continued monthly administration of GI-5005 and the subjects were treated for subsequent 12 week period. At the end of this period, subjects who achieve an EVR continued to receive GI-5005 plus SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR were followed for safety during a 36 week off treatment period. Any subject who discontinued SOC therapy due to intolerance at or prior to EVR assessment was treated with GI-5005 monotherapy for up to a total of 72 weeks.
1083700|NCT00606086|P2|Participant Flow|Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005|Subjects were treated with 12 weeks of SOC (Peg-IFN plus Ribavirin) therapy. Subjects who achieve an EVR continued to receive SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR, GI-5005 was added to SOC therapy and study drug administration continued for up to an additional 62 weeks. Subjects who discontinued SOC therapy due to intolerance were treated with GI-5005 monotherapy for up to 72 weeks.
1083701|NCT00606086|P1|Participant Flow|Arm 1: Peg-IFN/Ribavirin Plus GI-5005|Subjects were given GI-5005 alone for 12 weeks (5 weekly followed by 2 monthly doses). After completion of GI-5005 monotherapy run in period peg-IFN/ribavirin (SOC) therapy was added to continued monthly administration of GI-5005 and the subjects were treated for subsequent 12 week period. At the end of this period, subjects who achieve an EVR continued to receive GI-5005 plus SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR were followed for safety during a 36 week off treatment period. Any subject who discontinued SOC therapy due to intolerance at or prior to EVR assessment was treated with GI-5005 monotherapy for up to a total of 72 weeks.
1083702|NCT00606086|O2|Outcome|Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005|Subjects were treated with 12 weeks of SOC (Peg-IFN plus Ribavirin) therapy. Subjects who achieve an EVR continued to receive SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR, GI-5005 was added to SOC therapy and study drug administration continued for up to an additional 62 weeks. Subjects who discontinued SOC therapy due to intolerance were treated with GI-5005 monotherapy for up to 72 weeks.
1083703|NCT00606086|O1|Outcome|Arm 1: Peg-IFN/Ribavirin Plus GI-5005|Subjects were given GI-5005 alone for 12 weeks (5 weekly followed by 2 monthly doses). After completion of GI-5005 monotherapy run in period peg-IFN/ribavirin (SOC) therapy was added to continued monthly administration of GI-5005 and the subjects were treated for subsequent 12 week period. At the end of this period, subjects who achieve an EVR continued to receive GI-5005 plus SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR were followed for safety during a 36 week off treatment period. Any subject who discontinued SOC therapy due to intolerance at or prior to EVR assessment was treated with GI-5005 monotherapy for up to a total of 72 weeks.
1083704|NCT00606086|E2|Reported Event|Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005|Subjects were treated with 12 weeks of SOC (Peg-IFN plus Ribavirin) therapy. Subjects who achieve an EVR continued to receive SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR, GI-5005 was added to SOC therapy and study drug administration continued for up to an additional 62 weeks. Subjects who discontinued SOC therapy due to intolerance were treated with GI-5005 monotherapy for up to 72 weeks.
1083705|NCT00606086|E1|Reported Event|Arm 1: Peg-IFN/Ribavirin Plus GI-5005|Subjects were given GI-5005 alone for 12 weeks (5 weekly followed by 2 monthly doses). After completion of GI-5005 monotherapy run in period peg-IFN/ribavirin (SOC) therapy was added to continued monthly administration of GI-5005 and the subjects were treated for subsequent 12 week period. At the end of this period, subjects who achieve an EVR continued to receive GI-5005 plus SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR were followed for safety during a 36 week off treatment period. Any subject who discontinued SOC therapy due to intolerance at or prior to EVR assessment was treated with GI-5005 monotherapy for up to a total of 72 weeks.
1083706|NCT00606034|B1|Baseline|All Subjects Active|All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.
1083707|NCT00606034|P1|Participant Flow|All Subjects Active|All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.
1083708|NCT00606034|O1|Outcome|All Subjects|All subjects will receive the IDRSQ at baseline and at Week 52
1083709|NCT00606034|O1|Outcome|All Subjects|
1083710|NCT00606034|O1|Outcome|All Subjects Using U-500 Regular Insulin Via Omnipod|All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.
1083711|NCT00606034|E1|Reported Event|All Subjects Active|All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.
1083712|NCT00606021|B3|Baseline|Total|Total of all reporting groups
1083713|NCT00606021|B2|Baseline|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
1083714|NCT00606021|B1|Baseline|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles~Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
1083715|NCT00606021|P3|Participant Flow|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
1083716|NCT00606021|P2|Participant Flow|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 (mg/m²), IV, Day 1 of each 21-day cycle for 6 cycles~Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
1083717|NCT00606021|P1|Participant Flow|Pemetrexed Plus Cisplatin (Induction Phase)|Pemetrexed, 500 milligrams per square meter (mg/m²), intravenous (IV) followed by Cisplatin, IV, 75 mg/m² on Day 1 of each 21-day cycle for 4 cycles
1083748|NCT00605917|B1|Baseline|Sertraline|Participants taking Sertraline according to Japanese Package Insert
1083721|NCT00606021|O2|Outcome|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
1083722|NCT00606021|O1|Outcome|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles~Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
1083723|NCT00606021|O2|Outcome|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
1083724|NCT00606021|O1|Outcome|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles~Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
1083725|NCT00606021|O2|Outcome|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
1083726|NCT00606021|O1|Outcome|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles~Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
1083727|NCT00606021|O2|Outcome|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
1083728|NCT00606021|O1|Outcome|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles~Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
1083729|NCT00606021|O2|Outcome|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
1083730|NCT00606021|O1|Outcome|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles~Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
1083731|NCT00606021|E3|Reported Event|Pemetrexed + Cisplatin - Induction Phase|Pemetrexed, 500 milligrams per square meter (mg/m²), intravenous (IV) followed by Cisplatin, IV, 75 mg/m² on Day 1 of each 21-day cycle for 4 cycles.
1083732|NCT00606021|E2|Reported Event|Best Supportive Care - Maintenance Phase|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
1083733|NCT00606021|E1|Reported Event|Pemetrexed Plus Best Supportive Care - Maintenance Phase|Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
1083734|NCT00606008|B1|Baseline|Sutent Treatment|"Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.~Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study."
1083735|NCT00606008|P1|Participant Flow|Sutent Treatment|"Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.~Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study."
1083736|NCT00606008|O3|Outcome|GB Cohort Patients|Anaplastic astrocytoma (AA)patients
1083737|NCT00606008|O2|Outcome|AA Cohort Patients|Recurrent glioblastoma (GB) patients
1083738|NCT00606008|O1|Outcome|Sutent Treatment|"Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.~Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study."
1083739|NCT00606008|O3|Outcome|GB Cohort Patients|Anaplastic astrocytoma (AA)patients
1083740|NCT00606008|O2|Outcome|AA Cohort Patients|Recurrent glioblastoma (GB) patients
1083741|NCT00606008|O1|Outcome|Sutent Treatment|"Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.~Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study."
1083742|NCT00606008|O3|Outcome|GB Cohort Patients|Anaplastic astrocytoma (AA)patients
1083743|NCT00606008|O2|Outcome|AA Cohort Patients|Recurrent glioblastoma (GB) patients
1083744|NCT00606008|O1|Outcome|Sutent Treatment|"Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.~Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study."
1083745|NCT00606008|E3|Reported Event|GB Cohort Patients|Anaplastic astrocytoma (AA)patients
1083746|NCT00606008|E2|Reported Event|AA Cohort Patients|Recurrent glioblastoma (GB) patients
1083747|NCT00606008|E1|Reported Event|Sutent Treatment|"Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.~Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study."
1085019|NCT00603525|O1|Outcome|Placebo|
1083749|NCT00605917|P1|Participant Flow|Sertraline|"Participants taking Sertraline according to Japanese Package Insert; This study is Special Investigation of JZOLOFT for panic disorder and one of conditions of this study is patients who are diagnosed with panic disorder. So, all of participants in this study are panic disorder patients."
1083750|NCT00605917|O5|Outcome|Drank Alcohol Every Day|Participants who drank alcohol every day and who took Sertraline according to Japanese Package Insert
1083751|NCT00605917|O4|Outcome|Drank Alcohol Moderately|Participants who drank alcohol moderately and who took Sertraline according to Japanese Package Insert
1083752|NCT00605917|O3|Outcome|Used to Drink Alcohol But Did Not Then|Participants who used to drink alcohol but did not then and who took Sertraline according to Japanese Package Insert
1083753|NCT00605917|O2|Outcome|Drank Alcohol Very Occasionally|Participants who drank alcohol very occasionally and who took Sertraline according to Japanese Package Insert
1083754|NCT00605917|O1|Outcome|Didn’t Drink Alcohol at All, and Had Never Drunk Alcohol|Participants who didn’t drink alcohol at all, and had never drunk alcohol and who took Sertraline according to Japanese Package Insert
1083755|NCT00605917|O2|Outcome|Without Complications|Participants without complications who took Sertraline according to Japanese Package Insert
1083756|NCT00605917|O1|Outcome|With Complications|Participants with complications who took Sertraline according to Japanese Package Insert
1083757|NCT00605917|O2|Outcome|Without Concomitrant|Participants without concomitant drug who took Sertraline according to Japanese Package Insert
1083758|NCT00605917|O1|Outcome|With Concomitant Drug|Participants with concomitant drug who took Sertraline according to Japanese Package Insert
1083759|NCT00605917|O2|Outcome|Without Complications|Participants without complications who took Sertraline according to Japanese Package Insert
1083760|NCT00605917|O1|Outcome|With Complications|Participants with complications who took Sertraline according to Japanese Package Insert
1083761|NCT00605917|O5|Outcome|>=100mg|Participants who took more than 100mg of Sertraline a day on average according to Japanese Package Insert
1083762|NCT00605917|O4|Outcome|>=75mg, <100mg|Participants who took more than 75mg and less than 100mg of Sertraline a day on average according to Japanese Package Insert
1083763|NCT00605917|O3|Outcome|>=50mg, <75mg|Participants who took more than 50mg and less than 75mg of Sertraline a day on average according to Japanese Package Insert
1083764|NCT00605917|O2|Outcome|>=25mg, <50mg|Participants who took more than 25mg and less than 50mg of Sertraline a day on average according to Japanese Package Insert
1083765|NCT00605917|O1|Outcome|<25mg|Participants who took less than 25mg of Sertraline a day on average according to Japanese Package Insert
1083766|NCT00605917|O2|Outcome|Without History of Treatment|Participants without history of treatment prior to administration of Sertralin who took Sertraline according to Japanese Package Insert
1083767|NCT00605917|O1|Outcome|With History of Treatment|Participants with history of treatment prior to administration of Sertralin who took Sertraline according to Japanese Package Insert
1083768|NCT00605917|O2|Outcome|Without Non-pharmaceutical Therapies|Participants without non-pharmaceutical therapies who took Sertraline according to Japanese Package Insert
1083769|NCT00605917|O1|Outcome|With Non-pharmaceutical Therapies|Participants with non-pharmaceutical therapies who took Sertraline according to Japanese Package Insert
1083770|NCT00605917|O2|Outcome|Without Past Medical History of Other Illness|Participants without past medical history of other illness who took Sertraline according to Japanese Package Insert
1083771|NCT00605917|O1|Outcome|With Past Medical History of Other Illness|Participants with past medical history of other illness who took Sertraline according to Japanese Package Insert
1083772|NCT00605917|O3|Outcome|Smoke Then|Participants who smoke then and who took Sertraline according to Japanese Package Insert
1083773|NCT00605917|O2|Outcome|Used to Smoke But do Not Then|Participants who used to smoke but didn't then and who took Sertraline according to Japanese Package Insert
1083774|NCT00605917|O1|Outcome|Don’t Smoke at All|Participants who didn't smoke at all and who took Sertraline according to Japanese Package Insert
1083775|NCT00605917|O2|Outcome|Without Family History|Participants without family history of psychiatric disorders who took Sertraline according to Japanese Package Insert
1083776|NCT00605917|O1|Outcome|With Family History|Participants with family history of psychiatric disorders who took Sertraline according to Japanese Package Insert
1083777|NCT00605917|O2|Outcome|Without Concomitant Drug|Participants without concomitant drug who took Sertraline according to Japanese Package Insert
1083778|NCT00605917|O1|Outcome|With Concomitant Drug|Participants with concomitant drug who took Sertraline according to Japanese Package Insert
1083779|NCT00605917|O5|Outcome|Other Than Those Above|Participants whose starting dose were other than 25mg, 50mg, 75mg and 100mg
1083780|NCT00605917|O4|Outcome|100mg|Participants whose starting dose were 100mg
1083781|NCT00605917|O3|Outcome|75mg|Participants whose starting dose were 75mg
1083782|NCT00605917|O2|Outcome|50mg|Participants whose starting dose were 50mg
1083783|NCT00605917|O1|Outcome|25mg|Participants whose starting dose were 25mg
1083784|NCT00605917|O1|Outcome|Sertraline|Participants who took Sertraline according to Japanese Package Insert
1083785|NCT00605917|O1|Outcome|Sertraline|Participants who took Sertraline according to Japanese Package Insert
1083786|NCT00605917|E1|Reported Event|Sertraline|Participants taking Sertraline according to Japanese Package Insert.The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.
1083787|NCT00605904|B3|Baseline|Total|Total of all reporting groups
1083788|NCT00605904|B2|Baseline|Placebo|Subjects received 3 tablets of placebo three times daily
1083789|NCT00605904|B1|Baseline|Acamprosate|Subjects received 3 tablets of 333mg acamprosate three times daily
1083790|NCT00605904|P2|Participant Flow|Placebo|Subjects received 3 tablets of placebo three times daily
1083791|NCT00605904|P1|Participant Flow|Acamprosate|Subjects received 3 tablets of 333mg acamprosate three times daily
1083792|NCT00605904|O2|Outcome|Placebo|Subjects received 3 tablets of placebo three times daily
1083795|NCT00605904|O1|Outcome|Acamprosate|Subjects received 3 tablets of 333mg acamprosate three times daily
1083796|NCT00605904|O2|Outcome|Placebo|Subjects received 3 tablets of placebo three times daily
1083797|NCT00605904|O1|Outcome|Acamprosate|Subjects received 3 tablets of 333mg acamprosate three times daily
1083798|NCT00605904|E2|Reported Event|Placebo|Subjects received 3 tablets of placebo three times daily
1083799|NCT00605904|E1|Reported Event|Acamprosate|Subjects received 3 tablets of 333mg acamprosate three times daily
1083800|NCT00605865|B1|Baseline|Sertraline|Participants taking Sertraline according to Japanese Package Insert
1083801|NCT00605865|P1|Participant Flow|Sertraline|Participants taking Sertraline according to Japanese Package Insert
1083802|NCT00605865|O2|Outcome|Without Suicidal Ideation (Including Suicide Attempt)|Participants without suicidal ideation (including suicide attempt) who took Sertraline according to Japanese Package Insert
1083803|NCT00605865|O1|Outcome|With Suicidal Ideation (Including Suicide Attempt)|Participants with suicidal ideation (including suicide attempt) who took Sertraline according to Japanese Package Insert
1083804|NCT00605865|O4|Outcome|Over 65 Years of Age|Participants over 65 years of age who took Sertraline according to Japanese Package Insert
1083805|NCT00605865|O3|Outcome|45-64 Years of Age|Participants from 45 to 64 years of age who took Sertraline according to Japanese Package Insert
1083806|NCT00605865|O2|Outcome|18-44 Years of Age|Participants from 18 to 44 years of age who took Sertraline according to Japanese Package Insert
1083807|NCT00605865|O1|Outcome|Under 18 Years of Age|Participants under 18 years of age who took Sertraline according to Japanese Package Insert
1083808|NCT00605865|O2|Outcome|Under 15 Years|Participants under 15 years of age who took Sertraline according to Japanese Package Insert
1083809|NCT00605865|O1|Outcome|15 Years and Higher|Participants 15 years and higher of age who took Sertraline according to Japanese Package Insert
1083810|NCT00605865|O2|Outcome|Without Complications|Participants without complications who took Sertraline according to Japanese Package Insert
1083811|NCT00605865|O1|Outcome|With Complications|Participants with complications who took Sertraline according to Japanese Package Insert
1083812|NCT00605865|O2|Outcome|Outpatient|Participants as outpatients who took Sertraline according to Japanese Package Insert
1083813|NCT00605865|O1|Outcome|Inpatient|Participants as inpatients who took Sertraline according to Japanese Package Insert
1083814|NCT00605865|O2|Outcome|Without History of Treatment Prior to Sertraline|Participants without history of treatment prior to administration of Sertraline who took Sertraline according to Japanese Package Insert
1083815|NCT00605865|O1|Outcome|With History of Treatment Prior to Sertraline|Participants with history of treatment prior to administration of Sertraline who took Sertraline according to Japanese Package Insert
1083816|NCT00605865|O3|Outcome|Severe|Participants whose target disease are severe and who took Sertraline according to Japanese Package Insert
1083817|NCT00605865|O2|Outcome|Moderate|Participants whose target disease are moderate and who took Sertraline according to Japanese Package Insert
1083818|NCT00605865|O1|Outcome|Mild|Participants whose target disease are mild and who took Sertraline according to Japanese Package Insert
1083819|NCT00605865|O2|Outcome|Under 15 Years|Participants under 15 years of age who took Sertraline according to Japanese Package Insert
1083820|NCT00605865|O1|Outcome|15 Years and Higher|Participants 15 years and higher of age who took Sertraline according to Japanese Package Insert
1083821|NCT00605865|O2|Outcome|Without Suicidal Ideation (Including Suicide Attempt)|Participants without suicidal ideation (including suicide attempt) who took Sertraline according to Japanese Package Insert
1083822|NCT00605865|O1|Outcome|With Suicidal Ideation (Including Suicide Attempt)|Participants with suicidal ideation (including suicide attempt) who took Sertraline according to Japanese Package Insert
1083823|NCT00605865|O5|Outcome|>=100mg|Participants who took more than 100mg of Sertraline a day on average according to Japanese Package Insert
1083824|NCT00605865|O4|Outcome|>=75mg, <100mg|Participants who took more than 75mg and less than 100mg of Sertraline a day on average according to Japanese Package Insert
1083825|NCT00605865|O3|Outcome|>=50mg, <75mg|Participants who took more than 50mg and less than 75mg of Sertraline a day on average according to Japanese Package Insert
1083826|NCT00605865|O2|Outcome|>=25mg, <50mg|Participants who took more than 25mg and less than 50mg of Sertraline a day on average according to Japanese Package Insert
1083827|NCT00605865|O1|Outcome|<25mg|Participants who took less than 25mg of Sertraline a day on average according to Japanese Package Insert
1083828|NCT00605865|O2|Outcome|Without Past Medical History of Other Illness|Participants without past medical history of other illness who took Sertraline according to Japanese Package Insert
1083829|NCT00605865|O1|Outcome|With Past Medical History of Other Illness|Participants with past medical history of other illness who took Sertraline according to Japanese Package Insert
1083830|NCT00605865|O2|Outcome|Without Renal Dysfunction|Participants without renal dysfunction who took Sertraline according to Japanese Package Insert
1083831|NCT00605865|O1|Outcome|With Renal Dysfunction|Participants with renal dysfunction who took Sertraline according to Japanese Package Insert
1083832|NCT00605865|O2|Outcome|Without Concomitant Drug|Participants without concomitant drug who took Sertraline according to Japanese Package Insert
1083833|NCT00605865|O1|Outcome|With Concomitant Drug|Participants with concomitant drug who took Sertraline according to Japanese Package Insert
1083834|NCT00605865|O2|Outcome|Without Complications|Participants without complications who took Sertraline according to Japanese Package Insert
1083835|NCT00605865|O1|Outcome|With Complications|Participants with complications who took Sertraline according to Japanese Package Insert
1083836|NCT00605865|O1|Outcome|Sertraline|Participants who took Sertraline according to Japanese Package Insert
1083837|NCT00605865|O1|Outcome|Sertraline|Participants who took Sertraline according to Japanese Package Insert
1083838|NCT00605865|E1|Reported Event|Sertraline|Participants taking Sertraline according to Japanese Package Insert. All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.
1083841|NCT00605839|B2|Baseline|Cell Phone Only|Cell phone only, without the Glucopak. Participants will be given cell phones and encouraged to communicate more closely with the clinic, but will not use the Glucopak.
1083842|NCT00605839|B1|Baseline|Glucopak Cell Phone and Intensive Monitoring|Glucopak cell phone and intensive monitoring. This group will be given the experimental device, and placed in close communication with the clinic.
1083844|NCT00605839|P2|Participant Flow|Cell Phone Only|Cell phone only. Participants are given cell phones and encouraged to keep in contact with the clinic.
1083845|NCT00605839|P1|Participant Flow|Glucopak Cell Phone and Intensive Monitoring|Glucopak cell phone and intensive monitoring. Participants use the experimental device and are actively monitored by the clinic.
1083846|NCT00605839|O3|Outcome|Usual Care|Usual care, without cell phone or glucopak
1083847|NCT00605839|O2|Outcome|Cell Phone Only|Cell phone only, without the Glucopak. Participants will be given cell phones and encouraged to communicate more closely with the clinic, but will not use the Glucopak.
1083848|NCT00605839|O1|Outcome|Glucopak Cell Phone and Intensive Monitoring|Glucopak cell phone and intensive monitoring. This group will be given the experimental device, and placed in close communication with the clinic.
1083849|NCT00605839|E3|Reported Event|Usual Care|Usual care, without cell phone or glucopak
1083850|NCT00605839|E2|Reported Event|Cell Phone Only|Cell phone only, without the Glucopak. Participants will be given cell phones and encouraged to communicate more closely with the clinic, but will not use the Glucopak.
1083851|NCT00605839|E1|Reported Event|Glucopak Cell Phone and Intensive Monitoring|Glucopak cell phone and intensive monitoring. This group will be given the experimental device, and placed in close communication with the clinic.
1083852|NCT00605813|B1|Baseline|Sertraline|Participants taking Sertraline according to Japanese Package Insert
1083853|NCT00605813|P1|Participant Flow|Sertraline|Participants taking Sertraline according to Japanese Package Insert
1083854|NCT00605813|O2|Outcome|Present History of Intentional Suicidal Ideation|Participants with present intentional suicidal ideation (including suicide attempt) who took Sertraline according to Japanese Package Insert
1083855|NCT00605813|O1|Outcome|Past History of Intentional Suicidal Ideation|Participants with past history of intentional suicidal ideation (including suicide attempt) who took Sertraline according to Japanese Package Insert
1083856|NCT00605813|O2|Outcome|Without Non-pharmaceutical Therapies|Participants without non-pharmaceutical therapies who took Sertraline according to Japanese Package Insert
1083857|NCT00605813|O1|Outcome|With Non-pharmaceutical Therapies|Participants with non-pharmaceutical therapies who took Sertraline according to Japanese Package Insert
1083858|NCT00605813|O2|Outcome|With Past Medical History of Other Illness|Participants with past medical history of other illness who took Sertraline according to Japanese Package Insert
1083859|NCT00605813|O1|Outcome|Without Past Medical History of Other Illness|Participants without past medical history of other illness who took Sertraline according to Japanese Package Insert
1083860|NCT00605813|O2|Outcome|With Renal Dysfunction|Participants with renal dysfunction who took Sertraline according to Japanese Package Insert
1083861|NCT00605813|O1|Outcome|Without Renal Dysfunction|Participants without renal dysfunction who took Sertraline according to Japanese Package Insert
1083862|NCT00605813|O1|Outcome|Sertraline|Participants who took Sertraline according to Japanese Package Insert
1083863|NCT00605813|O1|Outcome|Sertraline Hydrochloride|Participants who took Sertraline according to Japanese Package Insert
1083864|NCT00605813|E1|Reported Event|Sertraline|Participants taking Sertraline according to Japanese Package Insert
1083865|NCT00605722|B1|Baseline|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
1083866|NCT00605722|P1|Participant Flow|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
1083867|NCT00605722|O1|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
1083868|NCT00605722|O1|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
1083869|NCT00605722|O1|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
1083870|NCT00605722|O1|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
1083871|NCT00605722|O1|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
1083872|NCT00605722|O1|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
1083873|NCT00605722|O1|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
1083874|NCT00605722|E1|Reported Event|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
1083875|NCT00605696|B3|Baseline|Total|Total of all reporting groups
1083876|NCT00605696|B2|Baseline|Control Group|"Participants will receive insulin to target 150-180 mg/dl for 48 hours after ICU admission followed by usual clinical care.~Insulin : Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) either in the ED or 48 hours after admission to the ICU."
1083877|NCT00605696|B1|Baseline|Early Insulin Group|"Participants will receive IIT within 6-12 hours after presenting to ED.~Insulin : Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) either in the ED or 48 hours after admission to the ICU."
1083878|NCT00605696|P2|Participant Flow|Control Group|Participants will receive insulin to target 150-180 mg/dl for 48 hours after ICU admission.
1083879|NCT00605696|P1|Participant Flow|Early Insulin Group|Participants will receive insulin to target glucose of 80-110 mg/dl within 6-12 hours after presenting to ED for up to 48 hours after admission to the ICU.
1083880|NCT00605696|O2|Outcome|Control Group|Participants will receive insulin to target 150-180 mg/dl for 48 hours after ICU admission followed by usual clinical care.
1083881|NCT00605696|O1|Outcome|Early Insulin Group|Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) in the ED and after ICU admission for up to 48 hours.
1083882|NCT00605696|O2|Outcome|Control Group|Participants will receive insulin to target 150-180 mg/dl for 48 hours after ICU admission followed by usual clinical care.
1083883|NCT00605696|O1|Outcome|Early Insulin Group|Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) in the ED and after ICU admission for up to 48 hours.
1083884|NCT00605696|E2|Reported Event|Control Group|"Participants will receive insulin to target 150-180 mg/dl for 48 hours after ICU admission followed by usual clinical care.~Insulin : Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) either in the ED or 48 hours after admission to the ICU."
1083885|NCT00605696|E1|Reported Event|Early Insulin Group|"Participants will receive IIT within 6-12 hours after presenting to ED.~Insulin : Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) either in the ED or 48 hours after admission to the ICU."
1083886|NCT00605657|B1|Baseline|Valproic Acid|valproic acid administered starting at 10 mg/kg/day in divided doses twice daily x 3 days, increase to 15mg/kg/day x 3 days, increase to 20 mg/kg/day on day 7, increase to 30 mg/kg/day on day 14, maximum dose of 40mg/kg/day on day 21, if tolerated, to achieve plasma level 50-100 mcg/mL.
1083887|NCT00605657|P1|Participant Flow|Valproic Acid|valproic acid administered starting at 10 mg/kg/day in divided doses twice daily x 3 days, increase to 15mg/kg/day x 3 days, increase to 20 mg/kg/day on day 7, increase to 30 mg/kg/day on day 14, maximum dose of 40mg/kg/day on day 21, if tolerated, to achieve plasma level 50-100 mcg/mL.
1083888|NCT00605657|O1|Outcome|Valproic Acid|valproic acid administered starting at 10 mg/kg/day in divided doses twice daily x 3 days, increase to 15mg/kg/day x 3 days, increase to 20 mg/kg/day on day 7, increase to 30 mg/kg/day on day 14, maximum dose of 40mg/kg/day on day 21, if tolerated, to achieve plasma level 50-100 mcg/mL.
1083889|NCT00605657|O1|Outcome|Valproic Acid|valproic acid administered starting at 10 mg/kg/day in divided doses twice daily x 3 days, increase to 15mg/kg/day x 3 days, increase to 20 mg/kg/day on day 7, increase to 30 mg/kg/day on day 14, maximum dose of 40mg/kg/day on day 21, if tolerated, to achieve plasma level 50-100 mcg/mL.
1083890|NCT00605657|E1|Reported Event|Valproic Acid|valproic acid administered starting at 10 mg/kg/day in divided doses twice daily x 3 days, increase to 15mg/kg/day x 3 days, increase to 20 mg/kg/day on day 7, increase to 30 mg/kg/day on day 14, maximum dose of 40mg/kg/day on day 21, if tolerated, to achieve plasma level 50-100 mcg/mL.
1083891|NCT00605540|B1|Baseline|Chronic Obstructive Pulmonary Disease Markers Over Three Years|All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
1083892|NCT00605540|P1|Participant Flow|Chronic Obstructive Pulmonary Disease Markers Over Three Years|All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
1083893|NCT00605540|O1|Outcome|Chronic Obstructive Pulmonary Disease Markers Over Three Years|All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
1083894|NCT00605540|O1|Outcome|Chronic Obstructive Pulmonary Disease Markers Over Three Years|All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
1083895|NCT00605540|O1|Outcome|Chronic Obstructive Pulmonary Disease Markers Over Three Years|All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
1083896|NCT00605540|O1|Outcome|Chronic Obstructive Pulmonary Disease Markers Over Three Years|All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
1083897|NCT00605540|O1|Outcome|Chronic Obstructive Pulmonary Disease Markers Over Three Years|All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
1083898|NCT00605540|E1|Reported Event|Chronic Obstructive Pulmonary Disease|
1083899|NCT00605475|B11|Baseline|Total|Total of all reporting groups
1083900|NCT00605475|B10|Baseline|Cohort 4: Placebo to Canakinumab 0.03 mg/kg|Single dose IV injection of Placebo to Canakinumab 0.03 mg/kg
1083901|NCT00605475|B9|Baseline|Cohort 4 : Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
1083902|NCT00605475|B8|Baseline|Cohort 3: Placebo Infusion|Single dose IV infusion of Placebo
1083903|NCT00605475|B7|Baseline|Cohort 3 : Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
1083904|NCT00605475|B6|Baseline|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
1083905|NCT00605475|B5|Baseline|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
1083906|NCT00605475|B4|Baseline|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Placebo to Canakinumab 10 mg/kg
1083907|NCT00605475|B3|Baseline|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1083908|NCT00605475|B2|Baseline|Cohort 1: Placebo to Canakinumab 0.3 mg/kg|Single dose IV infusion of placebo to Canakinumab 0.3 mg/kg
1083909|NCT00605475|B1|Baseline|Cohort 1: Canakinumab Infusion 0.3 mg/kg|Single dose intravenous (IV) infusion of canakinumab 0.3 mg/kg
1083910|NCT00605475|P10|Participant Flow|Cohort 4: Placebo to Canakinumab 0.03 mg/kg|Single dose IV injection of Placebo to Canakinumab 0.03 mg/kg
1083911|NCT00605475|P9|Participant Flow|Cohort 4 : Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
1083912|NCT00605475|P8|Participant Flow|Cohort 3: Placebo Infusion|Single dose IV infusion of Placebo
1083913|NCT00605475|P7|Participant Flow|Cohort 3 : Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
1083914|NCT00605475|P6|Participant Flow|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
1083915|NCT00605475|P5|Participant Flow|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
1083916|NCT00605475|P4|Participant Flow|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Placebo to Canakinumab 10 mg/kg
1083917|NCT00605475|P3|Participant Flow|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1083918|NCT00605475|P2|Participant Flow|Cohort 1: Placebo to Canakinumab 0.3 mg/kg|Single dose IV infusion of placebo to Canakinumab 0.3 mg/kg
1083919|NCT00605475|P1|Participant Flow|Cohort 1: Canakinumab Infusion 0.3 mg/kg|Single dose intravenous (IV) infusion of canakinumab 0.3 mg/kg
1083920|NCT00605475|O10|Outcome|Cohort 4: Placebo to Canakinumab 0.03 mg/kg|Single dose IV injection of Placebo to Canakinumab 0.03 mg/kg
1083921|NCT00605475|O9|Outcome|Cohort 4 : Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
1083922|NCT00605475|O8|Outcome|Cohort 3: Placebo Infusion|Single dose IV infusion of Placebo
1083923|NCT00605475|O7|Outcome|Cohort 3 : Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
1083924|NCT00605475|O6|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
1083925|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
1083926|NCT00605475|O4|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Placebo to Canakinumab 10 mg/kg
1083927|NCT00605475|O3|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1083928|NCT00605475|O2|Outcome|Cohort 1: Placebo to Canakinumab 0.3 mg/kg|Single dose IV infusion of placebo to Canakinumab 0.3 mg/kg
1083929|NCT00605475|O1|Outcome|Cohort 1: Canakinumab Infusion 0.3 mg/kg|Single dose intravenous (IV) infusion of canakinumab 0.3 mg/kg
1083930|NCT00605475|O7|Outcome|Cohort 4: Anakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
1083931|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4) : Placebo Infusion|Pooled placebo from cohort 3 and 4. Single dose IV infusion of Placebo
1083932|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
1083933|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
1083934|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
1083935|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1083936|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1083937|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
1083938|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled placebo from Cohort 3 and 4. Single dose IV infusion of Placebo
1083939|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
1083940|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
1083941|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
1083942|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1083943|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1083944|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1083945|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1083946|NCT00605475|O7|Outcome|Cohort 4:Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
1083947|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4) Placebo Infusion|Pooled placebo from Cohort 3 and 4. Single dose IV infusion of Placebo
1083948|NCT00605475|O5|Outcome|Cohort 3:Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
1083949|NCT00605475|O4|Outcome|Cohort 3:Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
1083950|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
1083951|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1083952|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1083953|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
1083954|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled placebo from cohort 3 and 4. Single dose IV infusion of Placebo
1083955|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
1083956|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
1083957|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
1083958|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1083959|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1083960|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
1083961|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled placebo of cohort 3 and 4. Single dose IV infusion of Placebo
1083962|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
1083963|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
1083964|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
1083965|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1083966|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1083967|NCT00605475|O7|Outcome|Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
1083968|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4) Placebo Infusion|Pooled placebo from cohort 3 and 4. Single dose IV infusion of Placebo
1083969|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
1083970|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
1083971|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
1083972|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1083973|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1083974|NCT00605475|O7|Outcome|Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
1083975|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4) Placebo Infusion|Pooled placebo from cohort 3 and 4. Single dose IV infusion of Placebo
1083976|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
1083977|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
1083978|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
1083979|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1083980|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1083981|NCT00605475|O7|Outcome|Cohort 4:Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
1083982|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled placebo from Cohort 3 and 4. Single dose IV infusion of Placebo
1083983|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
1083984|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
1083985|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
1083986|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1083987|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1083988|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
1083989|NCT00605475|O6|Outcome|Pooled (Cohort 3and 4): Placebo Infusion|Pooled Placebo of Cohort 3 and 4. Single dose IV infusion of Placebo
1083990|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
1083991|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
1083992|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
1083993|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1083994|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1083995|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
1083996|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4) Placebo Infusion|Pooled placebo from cohort 3 and 4. Single dose IV infusion of Placebo
1083997|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
1083998|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
1083999|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
1084000|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1084001|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1084002|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
1084003|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled placebo from cohort 3 and 4. ingle dose IV infusion of Placebo
1084004|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
1084005|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
1084006|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
1084007|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1084008|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1084009|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
1084010|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled placebo from Cohort 3 and 4. Single dose IV infusion of Placebo
1084011|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
1084012|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
1084013|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
1084014|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1084015|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1084016|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
1084017|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled Placebo of Cohort 3 and 4. Single dose IV infusion of Placebo
1084018|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
1084019|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
1084020|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
1084021|NCT00605475|O2|Outcome|Cohort 2:Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1084022|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1084023|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
1084024|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled Placebo of Cohort 3 and 4. Single dose IV infusion of Placebo
1084025|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
1084026|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
1084027|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
1084028|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1084029|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1084030|NCT00605475|E10|Reported Event|Cohort 4: Placebo to Canakinumab 0.03 mg/kg|Single dose IV injection of Placebo to Canakinumab 0.03 mg/kg
1084031|NCT00605475|E9|Reported Event|Cohort 4 : Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
1084032|NCT00605475|E8|Reported Event|Cohort 3: Placebo Infusion|Single dose IV infusion of Placebo
1084033|NCT00605475|E7|Reported Event|Cohort 3 : Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
1084034|NCT00605475|E6|Reported Event|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
1084035|NCT00605475|E5|Reported Event|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
1084036|NCT00605475|E4|Reported Event|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Placebo to Canakinumab 10 mg/kg
1084037|NCT00605475|E3|Reported Event|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
1084038|NCT00605475|E2|Reported Event|Cohort 1: Placebo to Canakinumab 0.3 mg/kg|Single dose IV infusion of placebo to Canakinumab 0.3 mg/kg
1084039|NCT00605475|E1|Reported Event|Cohort 1: Canakinumab Infusion 0.3 mg/kg|Single dose intravenous (IV) infusion of canakinumab 0.3 mg/kg
1084040|NCT00605423|B3|Baseline|Total|Total of all reporting groups
1084041|NCT00605423|B2|Baseline|Fluocinolone Acetonide: 0.5 ug/Day Implant|"Dose 0.5 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.5 ug/day implant"
1084042|NCT00605423|B1|Baseline|Fluocinolone Acetonide: 0.2 ug/Day Implant|"Dose 0.2 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.2 ug/day implant"
1084043|NCT00605423|P2|Participant Flow|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur implant
1084044|NCT00605423|P1|Participant Flow|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur implant
1084045|NCT00605423|O2|Outcome|Fluocinolone Acetonide: 0.5 ug/Day Implant|"Dose 0.5 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.5 ug/day implant"
1084046|NCT00605423|O1|Outcome|Fluocinolone Acetonide: 0.2 ug/Day Implant|"Dose 0.2 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.2 ug/day implant"
1084047|NCT00605423|O2|Outcome|Fluocinolone Acetonide: 0.5 ug/Day Implant|"Dose 0.5 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.5 ug/day implant"
1084048|NCT00605423|O1|Outcome|Fluocinolone Acetonide: 0.2 ug/Day Implant|"Dose 0.2 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.2 ug/day implant"
1084049|NCT00605423|O2|Outcome|Fluocinolone Acetonide: 0.5 ug/Day Implant|"Dose 0.5 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.5 ug/day implant"
1084050|NCT00605423|O1|Outcome|Fluocinolone Acetonide: 0.2 ug/Day Implant|"Dose 0.2 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.2 ug/day implant"
1084051|NCT00605423|E2|Reported Event|Fluocinolone Acetonide: 0.5 ug/Day Implant|"Dose 0.5 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.5 ug/day implant"
1084052|NCT00605423|E1|Reported Event|Fluocinolone Acetonide: 0.2 ug/Day Implant|"Dose 0.2 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.2 ug/day implant"
1084053|NCT00605384|B3|Baseline|Total|Total of all reporting groups
1084054|NCT00605384|B2|Baseline|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
1084055|NCT00605384|B1|Baseline|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
1084056|NCT00605384|P2|Participant Flow|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
1084057|NCT00605384|P1|Participant Flow|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
1084058|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
1084059|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
1084060|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
1084061|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
1084062|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
1084063|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
1084064|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
1084065|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
1084066|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
1084067|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
1084068|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
1084069|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
1084070|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
1084071|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
1084072|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
1084073|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
1084074|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
1084075|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
1084076|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
1084077|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
1084078|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
1084079|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
1084080|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
1084081|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
1084082|NCT00605384|E2|Reported Event|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
1084083|NCT00605384|E1|Reported Event|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
1084084|NCT00605358|B3|Baseline|Total|Total of all reporting groups
1084085|NCT00605358|B2|Baseline|Services Referral (Control)|"Subjects who do not receive the Open Door intervention will receive:~an evaluation~referral to a local mental health provider~booklet information on depression and mental health care, and will complete an application for HEAP, a Westchester County service that provides reduced rates from oil companies on heating to seniors."
1084086|NCT00605358|B1|Baseline|Open Door Intervention|"Open Door intervention: Open Door intervention subjects will:~receive an evaluation~receive a referral to a local mental health provider~identify barriers, set goals and problem-solve to achieve a mental health evaluation using available resources."
1084087|NCT00605358|P2|Participant Flow|Services Referral (Control)|"Subjects who do not receive the Open Door intervention will receive:~an evaluation~referral to a local mental health provider~booklet information on depression and mental health care, and will complete an application for HEAP, a Westchester County service that provides reduced rates from oil companies on heating to seniors."
1084088|NCT00605358|P1|Participant Flow|Open Door Intervention|"Open Door intervention: Open Door intervention subjects will:~receive an evaluation~receive a referral to a local mental health provider~identify barriers, set goals and problem-solve to achieve a mental health evaluation using available resources."
1084089|NCT00605358|O2|Outcome|Services Referral (Control)|"Subjects who do not receive the Open Door intervention will receive:~an evaluation~referral to a local mental health provider~booklet information on depression and mental health care, and will complete an application for HEAP, a Westchester County service that provides reduced rates from oil companies on heating to seniors."
1084090|NCT00605358|O1|Outcome|Open Door Intervention|"Open Door intervention: Open Door intervention subjects will:~receive an evaluation~receive a referral to a local mental health provider~identify barriers, set goals and problem-solve to achieve a mental health evaluation using available resources."
1084091|NCT00605358|E2|Reported Event|Services Referral (Control)|"Subjects who do not receive the Open Door intervention will receive:~an evaluation~referral to a local mental health provider~booklet information on depression and mental health care, and will complete an application for HEAP, a Westchester County service that provides reduced rates from oil companies on heating to seniors."
1084092|NCT00605358|E1|Reported Event|Open Door Intervention|"Open Door intervention: Open Door intervention subjects will:~receive an evaluation~receive a referral to a local mental health provider~identify barriers, set goals and problem-solve to achieve a mental health evaluation using available resources."
1084093|NCT00605345|B3|Baseline|Total|Total of all reporting groups
1084094|NCT00605345|B2|Baseline|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
1084095|NCT00605345|B1|Baseline|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
1084096|NCT00605345|P2|Participant Flow|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
1084097|NCT00605345|P1|Participant Flow|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
1084098|NCT00605345|O2|Outcome|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
1084099|NCT00605345|O1|Outcome|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
1084100|NCT00605345|O2|Outcome|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
1084101|NCT00605345|O1|Outcome|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
1084102|NCT00605345|O2|Outcome|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
1084103|NCT00605345|O1|Outcome|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
1084104|NCT00605345|O2|Outcome|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
1084105|NCT00605345|O1|Outcome|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
1084106|NCT00605345|O2|Outcome|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
1084107|NCT00605345|O1|Outcome|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
1084108|NCT00605345|O2|Outcome|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
1084109|NCT00605345|O1|Outcome|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
1084110|NCT00605345|E2|Reported Event|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
1084111|NCT00605345|E1|Reported Event|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
1084112|NCT00605306|B3|Baseline|Total|Total of all reporting groups
1084113|NCT00605306|B2|Baseline|Placebo|Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
1084114|NCT00605306|B1|Baseline|Indacaterol Maleate/Mometasone Furoate|Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
1084115|NCT00605306|P2|Participant Flow|Placebo|Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
1084398|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
1084116|NCT00605306|P1|Participant Flow|Indacaterol Maleate/Mometasone Furoate|Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
1084117|NCT00605306|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
1084118|NCT00605306|O1|Outcome|Indacaterol Maleate/Mometasone Furoate|Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
1084119|NCT00605306|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
1084120|NCT00605306|O1|Outcome|Indacaterol Maleate/Mometasone Furoate|Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
1084121|NCT00605306|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
1084122|NCT00605306|O1|Outcome|Indacaterol Maleate/Mometasone Furoate|Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
1084123|NCT00605306|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
1084124|NCT00605306|O1|Outcome|Indacaterol Maleate/Mometasone Furoate|Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
1084125|NCT00605306|E2|Reported Event|Placebo|Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
1084126|NCT00605306|E1|Reported Event|Indacaterol Maleate/Mometasone Furoate|Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
1084127|NCT00605293|B3|Baseline|Total|Total of all reporting groups
1084128|NCT00605293|B2|Baseline|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
1084129|NCT00605293|B1|Baseline|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
1084130|NCT00605293|P2|Participant Flow|Epoetin Alfa|Participants received IV injection of 6000 International Units (IU) of epoetin alfa every 3 weeks (q3wk) during the Stability Verification Period (SVP; Week -4 to -1), 7443 IU of epoetin alfa q3wk during Dose Titration Period (DTP; Week 0 to 15), and 7363 IU of epoetin alfa q3wk during Efficacy Evaluation Period (EEP; Week 16 to 23) up to 23 weeks.
1084131|NCT00605293|P1|Participant Flow|C.E.R.A|Participants received starting dose of 120, 200 or 360 micrograms (mcg) of C.E.R.A intravenously (IV) once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
1084132|NCT00605293|O2|Outcome|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
1084133|NCT00605293|O1|Outcome|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
1084134|NCT00605293|O2|Outcome|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
1084135|NCT00605293|O1|Outcome|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
1084136|NCT00605293|O2|Outcome|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
1084137|NCT00605293|O1|Outcome|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
1084138|NCT00605293|O2|Outcome|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
1084139|NCT00605293|O1|Outcome|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
1084140|NCT00605293|O2|Outcome|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
1084141|NCT00605293|O1|Outcome|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
1084142|NCT00605293|O2|Outcome|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
1084388|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
1084143|NCT00605293|O1|Outcome|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
1084144|NCT00605293|E2|Reported Event|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
1084145|NCT00605293|E1|Reported Event|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
1084146|NCT00605280|B5|Baseline|Total|Total of all reporting groups
1084147|NCT00605280|B4|Baseline|0.003 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.003 mg every 6 weeks was planned for up to 2 years. The 0.003 mg dose was removed and participants given option of receiving 0.3 mg injection of pegaptanib sodium every 6 weeks up to 2 years or withdrawing from study.
1084148|NCT00605280|B3|Baseline|0.03 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.03 mg every 6 weeks was planned for up to 2 years. The 0.03 mg dose was removed and participants given option of receiving 0.3 mg injection of pegaptanib sodium every 6 weeks up to 2 years or withdrawing from study.
1084149|NCT00605280|B2|Baseline|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
1084150|NCT00605280|B1|Baseline|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
1084151|NCT00605280|P4|Participant Flow|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
1084152|NCT00605280|P3|Participant Flow|0.003 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.003 mg every 6 weeks was planned for up to 2 years. The 0.003 mg dose was removed and participants given option of receiving 0.3 mg injection of pegaptanib sodium every 6 weeks up to 2 years or withdrawing from the study.
1084153|NCT00605280|P2|Participant Flow|0.03 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.03 mg every 6 weeks was planned for up to 2 years. The 0.03 mg dose was removed and participants given option of receiving 0.3 mg injection of pegaptanib sodium every 6 weeks for 2 years or withdrawing from the study.
1084154|NCT00605280|P1|Participant Flow|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
1084155|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
1084156|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
1084157|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
1084158|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
1084159|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
1084160|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
1084161|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
1084162|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
1084163|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
1084164|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
1084165|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
1084191|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084166|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
1084194|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084399|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
1084167|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
1084168|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
1084169|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
1084170|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
1084171|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
1084172|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
1084173|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
1084174|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
1084175|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
1084176|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
1084177|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
1084178|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
1084179|NCT00605280|E6|Reported Event|Sham Conversion (Year 3)|Participants who were originally randomized to Sham who enrolled in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
1084180|NCT00605280|E5|Reported Event|0.3 mg Pegaptanib Sodium (Year 3)|Participants who were originally randomized to pegaptanib sodium, 0.3 mg who enrolled in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
1084181|NCT00605280|E4|Reported Event|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe) from baseline up to Year 2. Events reported for participants after start of sham, but before they converted to 0.3 mg pegaptanib sodium or withdrew from study.
1084182|NCT00605280|E3|Reported Event|0.003 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.003 mg every 6 weeks was planned for up to 2 years. Events reported for participants after start of treatment, but before they converted to 0.3 mg pegaptanib sodium or withdrew from study.
1084183|NCT00605280|E2|Reported Event|0.03 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.03 mg every 6 weeks was planned for up to 2 years. Events reported for participants after start of treatment, but before they converted to 0.3 mg pegaptanib sodium or withdrew from study.
1084184|NCT00605280|E1|Reported Event|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks from baseline up to 2 years. Includes participants randomized to 0.3 mg pegaptanib sodium and participants randomized to lower doses of pegaptanib sodium who then converted to 0.3 mg pegaptanib sodium; for participants who converted to 0.3 mg pegaptanib sodium, only events that occurred while receiving 0.3 mg pegaptanib sodium treatment are reported.
1084185|NCT00605267|B3|Baseline|Total|Total of all reporting groups
1084186|NCT00605267|B2|Baseline|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084187|NCT00605267|B1|Baseline|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084188|NCT00605267|P2|Participant Flow|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084189|NCT00605267|P1|Participant Flow|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084190|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084389|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
1084192|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084193|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084195|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084196|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084197|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084198|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084199|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084200|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084201|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084202|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084203|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084204|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084205|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084206|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084207|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084208|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084209|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084210|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084211|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084212|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084213|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084214|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084215|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084216|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084217|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084218|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084219|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084220|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084221|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084222|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084223|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084224|NCT00605267|E2|Reported Event|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084225|NCT00605267|E1|Reported Event|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
1084226|NCT00605202|B1|Baseline|Entire Study Population|
1084227|NCT00605202|P2|Participant Flow|Licorice and HCTZ First, Then Licorice|Licorice 32 grams a day together with Hydrochlorothiazide 25 mg once daily in the first intervention period, then licorice 32 grams a day in the second intervention period.
1084228|NCT00605202|P1|Participant Flow|Licorice First, Then Licorice and HCTZ|Licorice 32 grams a day in the first intervention period, then licorice 32 grams a day together with Hydrochlorothiazide 25 mg once daily in the second intervention period.
1084229|NCT00605202|O2|Outcome|Licorice and HCTZ|
1084230|NCT00605202|O1|Outcome|Licorice|
1084231|NCT00605202|E2|Reported Event|Licorice and HCTZ|Licorice 32 grams a day together with Hydrochlorothiazide 25 mg once daily
1084232|NCT00605202|E1|Reported Event|Licorice|Licorice 32 grams a day
1084233|NCT00605176|B4|Baseline|Total|Total of all reporting groups
1084256|NCT00605150|P1|Participant Flow|Treatment|TheraSphere, TheraSphere-Yttrium 90 microsphere, treatment for patients with unresectable HCC
1084257|NCT00605150|O1|Outcome|TheraSphere Treatment|Total number of patients enrolled TheraSphere treatment for patients with unresectable HCC
1084234|NCT00605176|B3|Baseline|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
1084261|NCT00605085|B1|Baseline|IC51|IC51
1084262|NCT00605085|P2|Participant Flow|Placebo|Placebo
1084235|NCT00605176|B2|Baseline|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
1084236|NCT00605176|B1|Baseline|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
1084237|NCT00605176|P3|Participant Flow|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
1084238|NCT00605176|P2|Participant Flow|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
1084239|NCT00605176|P1|Participant Flow|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
1084240|NCT00605176|O3|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
1084241|NCT00605176|O2|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
1084242|NCT00605176|O1|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
1084243|NCT00605176|O3|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
1084244|NCT00605176|O2|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
1084245|NCT00605176|O1|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
1084246|NCT00605176|O3|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
1084247|NCT00605176|O2|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
1084248|NCT00605176|O1|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
1084249|NCT00605176|O3|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
1084250|NCT00605176|O2|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
1084251|NCT00605176|O1|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
1084252|NCT00605176|E3|Reported Event|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
1084253|NCT00605176|E2|Reported Event|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
1084254|NCT00605176|E1|Reported Event|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
1084255|NCT00605150|B1|Baseline|TheraSphere Treatment|Total number of patients enrolled, TheraSphere treatment
1084258|NCT00605150|E1|Reported Event|TheraSphere Treatment for Patients With Unresectable HCC|Total number of patients enrolled, TheraSphere treatment for patients with unresectable HCC
1084259|NCT00605085|B3|Baseline|Total|Total of all reporting groups
1084260|NCT00605085|B2|Baseline|Placebo|Placebo
1084269|NCT00605072|B3|Baseline|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
1084270|NCT00605072|B2|Baseline|ARB (Candesartan)|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
1084271|NCT00605072|B1|Baseline|ACEI (Lisinopril)|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
1084272|NCT00605072|P3|Participant Flow|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
1084273|NCT00605072|P2|Participant Flow|Candesartan|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
1084274|NCT00605072|P1|Participant Flow|Lisinopril|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
1084275|NCT00605072|O3|Outcome|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
1084276|NCT00605072|O2|Outcome|ARB (Candesartan)|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
1084277|NCT00605072|O1|Outcome|ACEI (Lisinopril)|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
1084278|NCT00605072|O3|Outcome|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
1084279|NCT00605072|O2|Outcome|ARB (Candesartan)|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
1084280|NCT00605072|O1|Outcome|ACEI (Lisinopril)|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
1084281|NCT00605072|O3|Outcome|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
1084331|NCT00604812|P3|Participant Flow|Panel B Rizatriptan|"Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 40 kg and above were allocated to Panel B."
1084282|NCT00605072|O2|Outcome|ARB (Candesartan)|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
1084301|NCT00605033|E1|Reported Event|Suboxone|Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone during Weeks 2-4 with weekly access to take-home doses as of Week 2.
1084400|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
1084283|NCT00605072|O1|Outcome|ACEI (Lisinopril)|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
1084284|NCT00605072|O3|Outcome|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
1084285|NCT00605072|O2|Outcome|ARB (Candesartan)|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
1084286|NCT00605072|O1|Outcome|ACEI (Lisinopril)|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
1084287|NCT00605072|O3|Outcome|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
1084288|NCT00605072|O2|Outcome|ARB (Candesartan)|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
1084289|NCT00605072|O1|Outcome|ACEI (Lisinopril)|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
1084290|NCT00605072|E3|Reported Event|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
1084291|NCT00605072|E2|Reported Event|ARB (Candesartan)|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
1084292|NCT00605072|E1|Reported Event|ACEI (Lisinopril)|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
1084293|NCT00605033|B3|Baseline|Total|Total of all reporting groups
1084294|NCT00605033|B2|Baseline|Subutex|Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex during Weeks 2-4 with weekly access to take-home doses as of Week 2.
1084295|NCT00605033|B1|Baseline|Suboxone|Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone during Weeks 2-4 with weekly access to take-home doses as of Week 2.
1084296|NCT00605033|P2|Participant Flow|Subutex|Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex during Weeks 2-4 with weekly access to take-home doses as of Week 2.
1084297|NCT00605033|P1|Participant Flow|Suboxone|Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone during Weeks 2-4 with weekly access to take-home doses as of Week 2.
1084298|NCT00605033|O2|Outcome|Subutex|Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex during Weeks 2-4 with weekly access to take-home doses as of Week 2.
1084299|NCT00605033|O1|Outcome|Suboxone|Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone during Weeks 2-4 with weekly access to take-home doses as of Week 2.
1084385|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
1084386|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
1084300|NCT00605033|E2|Reported Event|Subutex|Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex during Weeks 2-4 with weekly access to take-home doses as of Week 2.
1084395|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
1084396|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
1084302|NCT00604968|B1|Baseline|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
1084303|NCT00604968|P1|Participant Flow|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
1084304|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
1084305|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
1084306|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
1084307|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
1084308|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
1084309|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
1084310|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
1084311|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
1084312|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
1084313|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
1084314|NCT00604968|E1|Reported Event|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
1084315|NCT00604851|B3|Baseline|Total|Total of all reporting groups
1084316|NCT00604851|B2|Baseline|Placebo|placebo : participants < 30 kg: 15 mg po once daily participants <= 30 kg: 30 mg po once daily
1084317|NCT00604851|B1|Baseline|Lansoprazole|lansoprazole : participants < 30 kg: 15 mg po once daily
1084318|NCT00604851|P2|Participant Flow|Placebo|placebo medication, taken by mouth once daily
1084319|NCT00604851|P1|Participant Flow|Lansoprazole|lansoprazole : participants < 30 kg: 15 mg taken by mouth once daily, participants >= 30 kg: 30 mg taken by mouth once daily
1084320|NCT00604851|O2|Outcome|Placebo|placebo : participants < 30 kg: 15 mg po once daily participants <= 30 kg: 30 mg po once daily
1084321|NCT00604851|O1|Outcome|Lansoprazole|lansoprazole : participants < 30 kg: 15 mg po once daily
1084322|NCT00604851|E2|Reported Event|Placebo|placebo : participants < 30 kg: 15 mg po once daily participants <= 30 kg: 30 mg po once daily
1084323|NCT00604851|E1|Reported Event|Lansoprazole|lansoprazole : participants < 30 kg: 15 mg po once daily
1084324|NCT00604812|B4|Baseline|Total|Total of all reporting groups
1084325|NCT00604812|B3|Baseline|Panel C|Includes the participants who received 5 mg rizatriptan (n=1), 10 mg rizatriptan (n=4), and the matching placebo (n=1)
1084326|NCT00604812|B2|Baseline|Panel B|Includes the participants from the 10 mg rizatriptan group (10) and the matching placebo group (3)
1084327|NCT00604812|B1|Baseline|Panel A|Includes the participants from the 5 mg rizatriptan group (9) and the matching placebo group (3)
1084328|NCT00604812|P6|Participant Flow|Panel C Placebo|"Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT placebo on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg placebo dose and subjects weighing 40 kg and above received a 10 mg placebo dose.~Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group."
1084329|NCT00604812|P5|Participant Flow|Panel C Rizatriptan|"Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.~Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group."
1084330|NCT00604812|P4|Participant Flow|Panel B Placebo|"Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) placebo on Day 1.~Subjects weighing 40 kg and above were allocated to Panel B."
1084387|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
1084332|NCT00604812|P2|Participant Flow|Panel A Placebo|"Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) placebo on Day 1.~Subjects weighing 20-39 kg were allocated to Panel A."
1084333|NCT00604812|P1|Participant Flow|Panel A Rizatriptan|"Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 20-39 kg were allocated to Panel A."
1084397|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
1084334|NCT00604812|O3|Outcome|Panel C Rizatriptan|"Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.~Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group."
1084335|NCT00604812|O2|Outcome|Panel B Rizatriptan|"Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 40 kg and above were allocated to Panel B."
1084336|NCT00604812|O1|Outcome|Panel A Rizatriptan|"Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 20-39 kg were allocated to Panel A."
1084337|NCT00604812|O3|Outcome|Panel C Rizatriptan|"Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.~Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group."
1084338|NCT00604812|O2|Outcome|Panel B Rizatriptan|"Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 40 kg and above were allocated to Panel B."
1084339|NCT00604812|O1|Outcome|Panel A Rizatriptan|"Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 20-39 kg were allocated to Panel A."
1084340|NCT00604812|O3|Outcome|Panel C Rizatriptan|"Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.~Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group."
1084341|NCT00604812|O2|Outcome|Panel B Rizatriptan|"Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 40 kg and above were allocated to Panel B."
1084342|NCT00604812|O1|Outcome|Panel A Rizatriptan|"Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 20-39 kg were allocated to Panel A."
1084343|NCT00604812|O3|Outcome|Panel C Rizatriptan|"Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.~Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group."
1084344|NCT00604812|O2|Outcome|Panel B Rizatriptan|"Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 40 kg and above were allocated to Panel B."
1084345|NCT00604812|O1|Outcome|Panel A Rizatriptan|"Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 20-39 kg were allocated to Panel A."
1084346|NCT00604812|O3|Outcome|Placebo|Combined Placebo groups from panels A, B, and C.
1084347|NCT00604812|O2|Outcome|Rizatriptan 10 mg|Combined subjects from Panel B and Panel C randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.
1084348|NCT00604812|O1|Outcome|Rizatriptan 5 mg|Combined subjects from Panel A and Panel C randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.
1084349|NCT00604812|E3|Reported Event|Placebo|Combined Placebo groups from panels A, B, and C.
1084350|NCT00604812|E2|Reported Event|Rizatriptan 10 mg|Combined subjects from Panel B and Panel C randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.
1084351|NCT00604812|E1|Reported Event|Rizatriptan 5 mg|Combined subjects from Panel A and Panel C randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.
1084352|NCT00604786|B3|Baseline|Total|Total of all reporting groups
1084353|NCT00604786|B2|Baseline|Placebo|"placebo: IgE 30-100 int. units/mL: 30-90 kg: placebo every 4 weeks >90-150 kg: placebo every 4 weeks~IgE >100-200 int. units/mL:~30-90 kg: placebo every 4 weeks >90-150 kg: placebo every 2 weeks~IgE >200-300 int. units/mL:~30-60 kg: placebo every 4 weeks >60-90 kg: placebo every 2 weeks >90-150 kg: placebo every 2 weeks~IgE >300-400 int. units/mL:~30-70 kg: placebo every 2 weeks >70-90 kg: placebo every 2 weeks >90 kg: Do not administer dose~IgE >400-500 int. units/mL:~30-70 kg: placebo every 2 weeks >70-90 kg: placebo every 2 weeks >90 kg: Do not administer dose~IgE >500-600 int. units/mL:~30-60 kg: placebo every 2 weeks >60-70 kg: placebo every 2 weeks >70 kg: Do not administer dose~IgE >600-700 int. units/mL:~30-60 kg: placebo every 2 weeks >60 kg: Do not administer dose"
1084354|NCT00604786|B1|Baseline|Active Treatment|"This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma.~omalizumab: IgE 30-100 int. units/mL: 30-90 kg: 150 mg every 4 weeks >90-150 kg: 300 mg every 4 weeks~IgE >100-200 int. units/mL:~30-90 kg: 300 mg every 4 weeks >90-150 kg: 225 mg every 2 weeks~IgE >200-300 int. units/mL:~30-60 kg: 300 mg every 4 weeks >60-90 kg: 225 mg every 2 weeks >90-150 kg: 300 mg every 2 weeks~IgE >300-400 int. units/mL:~30-70 kg: 225 mg every 2 weeks >70-90 kg: 300 mg every 2 weeks >90 kg: Do not administer dose~IgE >400-500 int. units/mL:~30-70 kg: 300 mg every 2 weeks >70-90 kg: 375 mg every 2 weeks >90 kg: Do not administer dose~IgE >500-600 int. units/mL:~30-60 kg: 300 mg every 2 weeks >60-70 kg: 375 mg every 2 weeks >70 kg: Do not administer dose~IgE >600-700 int. units/mL:~30-60 kg: 375 mg every 2 weeks >60 kg: Do not administer dose"
1084355|NCT00604786|P2|Participant Flow|Placebo Subcutaneous|"This placebo arm will receive identical treatment with placebo injections subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections).~The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks."
1084356|NCT00604786|P1|Participant Flow|Omalizumab Subcutaneous|"This active are will receive treatment with omalizumab subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and immunoglobulin E (IgE) based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections).~The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks"
1084357|NCT00604786|O2|Outcome|Placebo Subcutaneous|"This placebo arm will receive identical treatment with placebo injections subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections).~The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks."
1084358|NCT00604786|O1|Outcome|Omalizumab Subcutaneous|"This active are will receive treatment with omalizumab subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections).~The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks"
1084359|NCT00604786|E2|Reported Event|Placebo Subcutaneous|"This placebo arm will receive identical treatment with placebo injections subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections).~The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks."
1084360|NCT00604786|E1|Reported Event|Omalizumab Subcutaneous|"This active are will receive treatment with omalizumab subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections).~The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks"
1084361|NCT00604721|B1|Baseline|AZD6244 Treatment|"The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a moderate liver dysfunction safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was to be determined by the algorithm presented in the safety cohort."
1084362|NCT00604721|P1|Participant Flow|AZD6244 Treatment|"The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a moderate liver dysfunction safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was to be determined by the algorithm presented in the safety cohort."
1084363|NCT00604721|O1|Outcome|AZD6244 Treatment|"The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a moderate liver dysfunction safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was to be determined by the algorithm presented in the safety cohort."
1084364|NCT00604721|O1|Outcome|AZD6244 Treatment|"The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a moderate liver dysfunction safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was to be determined by the algorithm presented in the safety cohort."
1084365|NCT00604721|O1|Outcome|Safety Cohort: AZD6244 Treatment|"The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a moderate liver dysfunction safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was determined by the algorithm presented in the safety cohort."
1084366|NCT00604721|E1|Reported Event|AZD6244 Treatment|"The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a moderate liver dysfunction safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was to be determined by the algorithm presented in the safety cohort."
1084367|NCT00604708|B3|Baseline|Total|Total of all reporting groups
1084368|NCT00604708|B2|Baseline|JE-VAX|JE-VAX
1084369|NCT00604708|B1|Baseline|IC51|IC51
1084370|NCT00604708|P2|Participant Flow|JE-VAX|JE-VAX
1084371|NCT00604708|P1|Participant Flow|IC51|IC51
1084372|NCT00604708|O2|Outcome|JE-VAX|JE-VAX
1084373|NCT00604708|O1|Outcome|IC51|IC51
1084374|NCT00604708|O2|Outcome|JE-VAX|JE-VAX
1084375|NCT00604708|O1|Outcome|IC51|IC51
1084376|NCT00604708|E2|Reported Event|JE-VAX|JE-VAX
1084377|NCT00604708|E1|Reported Event|IC51|IC51
1084378|NCT00604695|B3|Baseline|Total|Total of all reporting groups
1084379|NCT00604695|B2|Baseline|Placebo Control|Two (4mL) doses of sterile saline
1084380|NCT00604695|B1|Baseline|Active Treatment|Two (4mg) doses of tenecteplase
1084381|NCT00604695|P2|Participant Flow|Placebo Control|Two (4mL) doses of sterile saline
1084382|NCT00604695|P1|Participant Flow|Active Treatment|Two (4mg) doses of tenecteplase
1084383|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
1084384|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
1084390|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
1084391|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
1084392|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
1084393|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
1084394|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
1084401|NCT00604695|E2|Reported Event|Placebo Control|Two (4mL) doses of sterile saline
1084402|NCT00604695|E1|Reported Event|Active Treatment|Two (4mg) doses of tenecteplase
1084403|NCT00604669|B1|Baseline|Those Exposed to TPN|
1084404|NCT00604669|P1|Participant Flow|Those Exposed to TPN|
1084405|NCT00604669|O1|Outcome|Those Exposed to TPN|
1084406|NCT00604669|E1|Reported Event|Those Exposed to TPN|
1084407|NCT00604565|B3|Baseline|Total|Total of all reporting groups
1084408|NCT00604565|B2|Baseline|Standard Dialysate|"standard dialysate without soluble ferric pyrophosphate (SFP)~placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)"
1084409|NCT00604565|B1|Baseline|SFP Dialysate|"dialysate with added soluble ferric pyrophosphate (SFP)~soluble ferric pyrophosphate (SFP): Subjects will be randomized to undergo dialysis with Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL)."
1084410|NCT00604565|P2|Participant Flow|Standard Dialysate|"standard dialysate without soluble ferric pyrophosphate (SFP)~placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)"
1084411|NCT00604565|P1|Participant Flow|SFP Dialysate|"dialysate with added soluble ferric pyrophosphate (SFP)~soluble ferric pyrophosphate (SFP): Subjects will be randomized to undergo dialysis with Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL)."
1084412|NCT00604565|O2|Outcome|Standard Dialysate|"standard dialysate without soluble ferric pyrophosphate (SFP)~placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)"
1084413|NCT00604565|O1|Outcome|SFP Dialysate|"dialysate with added soluble ferric pyrophosphate (SFP)~soluble ferric pyrophosphate (SFP): Subjects will be randomized to undergo dialysis with Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL)."
1084414|NCT00604565|O2|Outcome|Standard Dialysate|"standard dialysate without soluble ferric pyrophosphate (SFP)~placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)"
1084415|NCT00604565|O1|Outcome|SFP Dialysate|"dialysate with added soluble ferric pyrophosphate (SFP)~soluble ferric pyrophosphate (SFP): Subjects will be randomized to undergo dialysis with Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL)."
1084416|NCT00604565|E2|Reported Event|Standard Dialysate|"standard dialysate without soluble ferric pyrophosphate (SFP)~placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)"
1084417|NCT00604565|E1|Reported Event|SFP Dialysate|"dialysate with added soluble ferric pyrophosphate (SFP)~soluble ferric pyrophosphate (SFP): Subjects will be randomized to undergo dialysis with Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL)."
1084418|NCT00604552|B3|Baseline|Total|Total of all reporting groups
1084419|NCT00604552|B2|Baseline|PS Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic
1084420|NCT00604552|B1|Baseline|Lifeline Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by the Foundation of Society for the Vascular Surgery (SVS)
1084421|NCT00604552|P2|Participant Flow|PS Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic
1084422|NCT00604552|P1|Participant Flow|Lifeline Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by the Foundation of Society for the Vascular Surgery (SVS)
1084423|NCT00604552|O2|Outcome|PS Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic
1084424|NCT00604552|O1|Outcome|Lifeline Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by the Foundation of Society for the Vascular Surgery (SVS)
1084425|NCT00604552|E2|Reported Event|PS Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic
1084426|NCT00604552|E1|Reported Event|Lifeline Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by the Foundation of Society for the Vascular Surgery (SVS)
1084427|NCT00604500|B1|Baseline|MF/F MDI 100/10 mcg BID (With Dose Counter)|MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of 50/5 mcg, twice a day) over a 4-week Treatment Period.
1084428|NCT00604500|P1|Participant Flow|MF/F MDI 100/10 mcg BID (With Dose Counter)|MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of 50/5 mcg, twice a day) over a 4-week Treatment Period.
1084429|NCT00604500|O1|Outcome|MF/F MDI 100/10 mcg BID (With Dose Counter)|MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of 50/5 mcg, twice a day) over a 4-week Treatment Period.
1084430|NCT00604500|O1|Outcome|MF/F MDI 100/10 mcg BID (With Dose Counter)|MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of 50/5 mcg, twice a day) over a 4-week Treatment Period.
1084500|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
1084431|NCT00604500|O1|Outcome|MF/F MDI 100/10 mcg BID (With Dose Counter)|MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of 50/5 mcg, twice a day) over a 4-week Treatment Period.
1084432|NCT00604500|O1|Outcome|MF/F MDI 100/10 mcg BID (With Dose Counter)|MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of 50/5 mcg, twice a day) over a 4-week Treatment Period.
1084433|NCT00604500|E1|Reported Event|MF/F MDI 100/10 mcg BID|Included all participants that received 100/10 mcg BID (with and without dose counter)
1084505|NCT00604214|E1|Reported Event|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
1084506|NCT00604188|B3|Baseline|Total|Total of all reporting groups
1084532|NCT00604175|B1|Baseline|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
1084434|NCT00604461|B1|Baseline|Dose Escalation Followed by Maintenance Therapy|"A: Tiered Dose Escalation/Phase II Dose. Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2.~B: Maintenance Therapy - Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first."
1084435|NCT00604461|P1|Participant Flow|Dose Escalation Followed by Maintenance Therapy|"A: Tiered Dose Escalation/Phase II Dose. Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2.~B: Maintenance Therapy - Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first."
1084436|NCT00604461|O1|Outcome|Dose Escalation Followed by Maintenance Therapy|"A: Tiered Dose Escalation/Phase II Dose. Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2.~B: Maintenance Therapy - Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first."
1084437|NCT00604461|O1|Outcome|Dose Escalation Followed by Maintenance Therapy|"A: Tiered Dose Escalation/Phase II Dose. Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2.~B: Maintenance Therapy - Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first."
1084438|NCT00604461|E1|Reported Event|Dose Escalation Followed by Maintenance Therapy|"A: Tiered Dose Escalation/Phase II Dose. Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2.~B: Maintenance Therapy - Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first."
1084439|NCT00604383|B3|Baseline|Total|Total of all reporting groups
1084440|NCT00604383|B2|Baseline|Placebo|1 tablet, orally, daily, for up to 42 months
1084441|NCT00604383|B1|Baseline|Ruboxistaurin|One 32-mg tablet, orally, daily, for up to 42 months
1084442|NCT00604383|P2|Participant Flow|Placebo|1 tablet, orally, daily, for up to 42 months
1084443|NCT00604383|P1|Participant Flow|Ruboxistaurin|One 32-milligram (mg) tablet, orally, daily, for up to 42 months
1084444|NCT00604383|O2|Outcome|Placebo|1 tablet, orally, daily, for 36 months
1084445|NCT00604383|O1|Outcome|Ruboxistaurin|One 32-mg tablet, orally, daily, for 36 months
1084446|NCT00604383|O2|Outcome|Placebo|1 tablet, orally, daily, for 36 months
1084447|NCT00604383|O1|Outcome|Ruboxistaurin|One 32-mg tablet, orally, daily, for 36 months
1084448|NCT00604383|O2|Outcome|Placebo|1 tablet, orally, daily, for 36 months
1084449|NCT00604383|O1|Outcome|Ruboxistaurin|One 32-mg tablet, orally, daily, for 36 months
1084450|NCT00604383|O2|Outcome|Placebo|1 tablet, orally, daily, for 36 months
1084451|NCT00604383|O1|Outcome|Ruboxistaurin|One 32-mg tablet, orally, daily, for 36 months
1084452|NCT00604383|O2|Outcome|Placebo|1 tablet, orally, daily, for 36 months
1084453|NCT00604383|O1|Outcome|Ruboxistaurin|One 32-mg tablet, orally, daily, for 36 months
1084454|NCT00604383|E2|Reported Event|Placebo|1 tablet, orally, daily, for up to 42 months
1084455|NCT00604383|E1|Reported Event|Ruboxistaurin|One 32-mg tablet, orally, daily, for up to 42 months
1084456|NCT00604279|B3|Baseline|Total|Total of all reporting groups
1084457|NCT00604279|B2|Baseline|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
1084458|NCT00604279|B1|Baseline|Paliperidone Palmitate|Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator’s discretion.
1084459|NCT00604279|P2|Participant Flow|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
1084460|NCT00604279|P1|Participant Flow|Paliperidone Palmitate|Paliperidone palmitate (R092670) suspension for intramuscular (directly into a muscle) injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator’s discretion.
1084461|NCT00604279|O2|Outcome|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
1084501|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
1084502|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
1084462|NCT00604279|O1|Outcome|Paliperidone Palmitate|Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator’s discretion.
1084507|NCT00604188|B2|Baseline|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
1084463|NCT00604279|O2|Outcome|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
1084464|NCT00604279|O1|Outcome|Paliperidone Palmitate|Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator’s discretion.
1084465|NCT00604279|O2|Outcome|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
1084466|NCT00604279|O1|Outcome|Paliperidone Palmitate|Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator’s discretion.
1084467|NCT00604279|O2|Outcome|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
1084468|NCT00604279|O1|Outcome|Paliperidone Palmitate|Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator’s discretion.
1084469|NCT00604279|O2|Outcome|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
1084470|NCT00604279|O1|Outcome|Paliperidone Palmitate|Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator’s discretion.
1084471|NCT00604279|E2|Reported Event|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
1084472|NCT00604279|E1|Reported Event|Paliperidone Palmitate|Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator’s discretion.
1084473|NCT00604214|B3|Baseline|Total|Total of all reporting groups
1084474|NCT00604214|B2|Baseline|Placebo|0.9% sodium chloride, intravenous, 96 hours
1084475|NCT00604214|B1|Baseline|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
1084476|NCT00604214|P2|Participant Flow|Placebo|0.9% sodium chloride, intravenous, 96 hours
1084477|NCT00604214|P1|Participant Flow|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
1084478|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
1084479|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
1084480|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
1084481|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
1084482|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
1084483|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
1084484|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
1084485|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
1084486|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
1084487|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
1084488|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
1084489|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
1084490|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
1084491|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
1084492|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
1084493|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
1084494|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
1084495|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
1084496|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
1084497|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
1084498|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
1084499|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
1084503|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
1084504|NCT00604214|E2|Reported Event|Placebo|0.9% sodium chloride, intravenous, 96 hours
1084508|NCT00604188|B1|Baseline|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
1084509|NCT00604188|P2|Participant Flow|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
1084510|NCT00604188|P1|Participant Flow|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
1084511|NCT00604188|O2|Outcome|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
1084512|NCT00604188|O1|Outcome|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
1084513|NCT00604188|O2|Outcome|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
1084514|NCT00604188|O1|Outcome|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
1084515|NCT00604188|O2|Outcome|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
1084516|NCT00604188|O1|Outcome|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
1084517|NCT00604188|O2|Outcome|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
1084518|NCT00604188|O1|Outcome|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
1084519|NCT00604188|O2|Outcome|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
1084520|NCT00604188|O1|Outcome|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
1084521|NCT00604188|O2|Outcome|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
1084522|NCT00604188|O1|Outcome|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
1084523|NCT00604188|O2|Outcome|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
1084524|NCT00604188|O1|Outcome|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
1084525|NCT00604188|O2|Outcome|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
1084526|NCT00604188|O1|Outcome|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
1084527|NCT00604188|E2|Reported Event|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
1084568|NCT00604175|O1|Outcome|Stratum A/Baseline HPV11-|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seronegative for HPV11 at baseline.
1084528|NCT00604188|E1|Reported Event|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
1084529|NCT00604175|B4|Baseline|Total|Total of all reporting groups
1084530|NCT00604175|B3|Baseline|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
1084531|NCT00604175|B2|Baseline|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
1084533|NCT00604175|P3|Participant Flow|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
1084534|NCT00604175|P2|Participant Flow|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
1084535|NCT00604175|P1|Participant Flow|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
1084536|NCT00604175|O3|Outcome|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
1084537|NCT00604175|O2|Outcome|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
1084538|NCT00604175|O1|Outcome|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
1084539|NCT00604175|O3|Outcome|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
1084540|NCT00604175|O2|Outcome|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
1084541|NCT00604175|O1|Outcome|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
1084542|NCT00604175|O3|Outcome|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
1084543|NCT00604175|O2|Outcome|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
1084544|NCT00604175|O1|Outcome|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
1084545|NCT00604175|O3|Outcome|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
1084546|NCT00604175|O2|Outcome|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
1084547|NCT00604175|O1|Outcome|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
1084548|NCT00604175|O3|Outcome|Stratum C/Baseline HPV18+|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seropositive for HPV18 at baseline.
1084549|NCT00604175|O2|Outcome|Stratum B/Baseline HPV18+|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seropositive for HPV18 at baseline.
1084550|NCT00604175|O1|Outcome|Stratum A/Baseline HPV18+|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seropositive for HPV18 at baseline.
1084551|NCT00604175|O3|Outcome|Stratum C/Baseline HPV16+|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seropositive for HPV16 at baseline.
1084552|NCT00604175|O2|Outcome|Stratum B/Baseline HPV16+|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seropositive for HPV16 at baseline.
1084553|NCT00604175|O1|Outcome|Stratum A/Baseline HPV16+|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seropositive for HPV16 at baseline.
1084554|NCT00604175|O3|Outcome|Stratum C/Baseline HPV11+|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seropositive for HPV11 at baseline.
1084555|NCT00604175|O2|Outcome|Stratum B/Baseline HPV11+|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seropositive for HPV11 at baseline.
1084556|NCT00604175|O1|Outcome|Stratum A/Baseline HPV11+|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seropositive for HPV11 at baseline.
1084557|NCT00604175|O3|Outcome|Stratum C/Baseline HPV6+|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seropositive for HPV6 at baseline.
1084558|NCT00604175|O2|Outcome|Stratum B/Baseline HPV6+|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seropositive for HPV6 at baseline.
1084559|NCT00604175|O1|Outcome|Stratum A/Baseline HPV6+|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seropositive for HPV6 at baseline.
1084560|NCT00604175|O3|Outcome|Stratum C/Baseline HPV18-|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seronegative for HPV18 at baseline.
1084561|NCT00604175|O2|Outcome|Stratum B/Baseline HPV18-|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seronegative for HPV18 at baseline.
1084562|NCT00604175|O1|Outcome|Stratum A/Baseline HPV18-|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seronegative for HPV18 at baseline.
1084563|NCT00604175|O3|Outcome|Stratum C/Baseline HPV16-|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seronegative for HPV16 at baseline.
1084564|NCT00604175|O2|Outcome|Stratum B/Baseline HPV16-|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seronegative for HPV16 at baseline.
1084565|NCT00604175|O1|Outcome|Stratum A/Baseline HPV16-|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seronegative for HPV16 at baseline.
1084566|NCT00604175|O3|Outcome|Stratum C/Baseline HPV11-|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seronegative for HPV11 at baseline.
1084567|NCT00604175|O2|Outcome|Stratum B/Baseline HPV11-|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seronegative for HPV11 at baseline.
1084569|NCT00604175|O3|Outcome|Stratum C/Baseline HPV6-|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seronegative for HPV6 at baseline.
1084570|NCT00604175|O2|Outcome|Stratum B/Baseline HPV6-|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seronegative for HPV6 at baseline.
1084571|NCT00604175|O1|Outcome|Stratum A/Baseline HPV6-|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seronegative for HPV6 at baseline.
1084572|NCT00604175|O3|Outcome|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
1084573|NCT00604175|O2|Outcome|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
1084574|NCT00604175|O1|Outcome|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
1084575|NCT00604175|O3|Outcome|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
1084576|NCT00604175|O2|Outcome|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
1084577|NCT00604175|O1|Outcome|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
1084578|NCT00604175|O3|Outcome|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
1084579|NCT00604175|O2|Outcome|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
1084580|NCT00604175|O1|Outcome|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
1084581|NCT00604175|O3|Outcome|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
1084582|NCT00604175|O2|Outcome|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
1084583|NCT00604175|O1|Outcome|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
1084584|NCT00604175|E3|Reported Event|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
1084585|NCT00604175|E2|Reported Event|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
1084586|NCT00604175|E1|Reported Event|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
1084587|NCT00604162|B1|Baseline|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison."
1084588|NCT00604162|P1|Participant Flow|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison."
1084589|NCT00604162|O1|Outcome|PillCam COLON|Ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy.
1084590|NCT00604162|O1|Outcome|PillCam COLON|Ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy.
1084591|NCT00604162|O1|Outcome|Standard Colonoscopy|"After bowel preparation and capsule endoscopy, patients subsequently had standard colonoscopy as gold standard comparison (with colon insufflation and sedation)."
1084592|NCT00604162|O2|Outcome|Standard Colonoscopy|"After bowel preparation and capsule endoscopy, patients subsequently had standard colonoscopy as gold standard comparison (with colon insufflation and sedation)."
1084593|NCT00604162|O1|Outcome|PillCam COLON|Ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy.
1084594|NCT00604162|O2|Outcome|Standard Colonoscopy|"After bowel preparation and capsule endoscopy, patients subsequently had standard colonoscopy as gold standard comparison (with colon insufflation and sedation)."
1084595|NCT00604162|O1|Outcome|PillCam COLON|Ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy.
1084596|NCT00604162|E2|Reported Event|Adverse Events Related to the Capsule|AE related to the capsule endoscopy procedure
1084597|NCT00604162|E1|Reported Event|Adverse Events Related to Colonoscopy|AE related to colonoscopy procedure
1084598|NCT00604045|B3|Baseline|Total|Total of all reporting groups
1084599|NCT00604045|B2|Baseline|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
1084600|NCT00604045|B1|Baseline|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
1084601|NCT00604045|P2|Participant Flow|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
1084631|NCT00603915|O1|Outcome|GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB|patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
1084602|NCT00604045|P1|Participant Flow|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
1084603|NCT00604045|O2|Outcome|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
1084604|NCT00604045|O1|Outcome|1 Attention Bias Modification (ABM)|"The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.~be."
1084605|NCT00604045|E2|Reported Event|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
1084606|NCT00604045|E1|Reported Event|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
1084607|NCT00604019|B3|Baseline|Total|Total of all reporting groups
1084608|NCT00604019|B2|Baseline|Norepinephrine|Patients that get NE infusion
1084609|NCT00604019|B1|Baseline|Dopamine|Patients that get DA infusion
1084610|NCT00604019|P2|Participant Flow|Norepinephrine|Norepinephrine infusion via central catheter
1084611|NCT00604019|P1|Participant Flow|Dopamine|Dopaime infusion via central catheter
1084612|NCT00604019|O2|Outcome|Norepinephrine|Patients getting NE infusion
1084613|NCT00604019|O1|Outcome|Dopamine|Patients getting DA infusion
1084614|NCT00604019|E2|Reported Event|Norepinephrine|Patients that get NE infusion
1084615|NCT00604019|E1|Reported Event|Dopamine|Patients that get DA infusion
1084616|NCT00603993|B1|Baseline|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
1084617|NCT00603993|P1|Participant Flow|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
1084618|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
1084619|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
1084620|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
1084621|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
1084622|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
1084623|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
1084624|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
1084625|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
1084626|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
1084627|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
1084628|NCT00603993|E1|Reported Event|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
1084629|NCT00603915|B1|Baseline|GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB|patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
1084630|NCT00603915|P1|Participant Flow|GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB|patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
1084632|NCT00603915|O1|Outcome|GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB|patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
1084633|NCT00603915|E1|Reported Event|GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB|patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
1084634|NCT00603902|B4|Baseline|Total|Total of all reporting groups
1084635|NCT00603902|B3|Baseline|Matching Placebo|matching placebo tablets
1084636|NCT00603902|B2|Baseline|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
1084637|NCT00603902|B1|Baseline|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
1084638|NCT00603902|P3|Participant Flow|Matching Placebo|matching placebo tablets
1084639|NCT00603902|P2|Participant Flow|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
1084640|NCT00603902|P1|Participant Flow|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
1084641|NCT00603902|O3|Outcome|Matching Placebo|matching placebo tablets
1084642|NCT00603902|O2|Outcome|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
1084643|NCT00603902|O1|Outcome|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
1084644|NCT00603902|O3|Outcome|Matching Placebo|matching placebo tablets
1084645|NCT00603902|O2|Outcome|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
1084646|NCT00603902|O1|Outcome|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
1084647|NCT00603902|E3|Reported Event|Matching Placebo|matching placebo tablets
1084648|NCT00603902|E2|Reported Event|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
1084649|NCT00603902|E1|Reported Event|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
1084650|NCT00603889|B1|Baseline|Na-ASP-2 Hookworm Antigen Skin Test|All participants will have the same number of concentrations of the Na-ASP-2 skin test reagent applied to their arms, using both the prick-puncture and intradermal techniques.
1084651|NCT00603889|P1|Participant Flow|Na-ASP-2 Hookworm Antigen Skin Test|All participants will have the same number of concentrations of the Na-ASP-2 skin test reagent applied to their arms, using both the prick-puncture and intradermal techniques.
1084652|NCT00603889|O1|Outcome|Na-ASP-2 Hookworm Antigen Skin Test|"Application of different concentrations of the Na-ASP-2 antigen skin test reagent as prick-puncture (scratch test) and intradermal injections, applied to participants' forearms."
1084653|NCT00603889|O1|Outcome|Na-ASP-2 Hookworm Antigen Skin Test|"Application of different concentrations of the Na-ASP-2 antigen skin test reagent as prick-puncture (scratch test) and intradermal injections, applied to participants' forearms."
1084654|NCT00603889|O1|Outcome|Na-ASP-2 Hookworm Antigen Skin Test|"Application of different concentrations of the Na-ASP-2 antigen skin test reagent as prick-puncture (scratch test) and intradermal injections, applied to participants' forearms."
1084655|NCT00603889|O1|Outcome|Na-ASP-2 Hookworm Antigen Skin Test|"Application of different concentrations of the Na-ASP-2 antigen skin test reagent as prick-puncture (scratch test) and intradermal injections, applied to participants' forearms."
1084656|NCT00603889|E1|Reported Event|Na-ASP-2 Hookworm Antigen Skin Test|All participants will have the same number of concentrations of the Na-ASP-2 skin test reagent applied to their arms, using both the prick-puncture and intradermal techniques.
1084657|NCT00603837|B3|Baseline|Total|Total of all reporting groups
1084658|NCT00603837|B2|Baseline|Wrap|This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery.
1084659|NCT00603837|B1|Baseline|Blanket|This arm includes those ELGANs who are to be placed on a sodium acetate warming blanket after delivery.
1084660|NCT00603837|P2|Participant Flow|Wrap|This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery.
1084661|NCT00603837|P1|Participant Flow|Blanket|This arm includes those ELGANs who are to be placed on a sodium acetate warming blanket after delivery.
1084662|NCT00603837|O2|Outcome|Wrap|This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery.
1084663|NCT00603837|O1|Outcome|Blanket|This arm includes those ELGANs who are to be placed on a sodium acetate warming blanket after delivery.
1084664|NCT00603837|E2|Reported Event|Wrap|This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery.
1084665|NCT00603837|E1|Reported Event|Blanket|This arm includes those ELGANs who are to be placed on a sodium acetate warming blanket after delivery.
1084666|NCT00603798|B4|Baseline|Total|Total of all reporting groups
1084667|NCT00603798|B3|Baseline|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
1084668|NCT00603798|B2|Baseline|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
1084669|NCT00603798|B1|Baseline|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
1084670|NCT00603798|P3|Participant Flow|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
1084671|NCT00603798|P2|Participant Flow|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
1084672|NCT00603798|P1|Participant Flow|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
1085121|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
1084673|NCT00603798|O3|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
1084674|NCT00603798|O2|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
1085020|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1084675|NCT00603798|O1|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
1084676|NCT00603798|O3|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
1084677|NCT00603798|O2|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
1084678|NCT00603798|O1|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
1084679|NCT00603798|O3|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
1084680|NCT00603798|O2|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
1084681|NCT00603798|O1|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
1084682|NCT00603798|O3|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
1084683|NCT00603798|O2|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
1084684|NCT00603798|O1|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
1084685|NCT00603798|E3|Reported Event|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
1084686|NCT00603798|E2|Reported Event|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
1084687|NCT00603798|E1|Reported Event|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
1084688|NCT00603746|B7|Baseline|Total|Total of all reporting groups
1084689|NCT00603746|B6|Baseline|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084690|NCT00603746|B5|Baseline|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084691|NCT00603746|B4|Baseline|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084692|NCT00603746|B3|Baseline|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084693|NCT00603746|B2|Baseline|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084881|NCT00603590|O1|Outcome|Polypill|Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)
1084882|NCT00603590|O2|Outcome|Control|Identical placebo tablet
1084694|NCT00603746|B1|Baseline|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1085021|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1084695|NCT00603746|P6|Participant Flow|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the
1084696|NCT00603746|P5|Participant Flow|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084697|NCT00603746|P4|Participant Flow|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084698|NCT00603746|P3|Participant Flow|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084699|NCT00603746|P2|Participant Flow|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084700|NCT00603746|P1|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084701|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084702|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084703|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084704|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084705|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084706|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084707|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084708|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084709|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084710|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084711|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084883|NCT00603590|O1|Outcome|Polypill|Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)
1084884|NCT00603590|O2|Outcome|Control|Identical placebo tablet
1084885|NCT00603590|O1|Outcome|Polypill|Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)
1084712|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084713|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084714|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084715|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084716|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084717|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084718|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084719|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084720|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084721|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084722|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084723|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084724|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084725|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084726|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084727|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084728|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084729|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084886|NCT00603590|E2|Reported Event|Control|Identical placebo tablet
1084887|NCT00603590|E1|Reported Event|Polypill|Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)
1084888|NCT00603564|B3|Baseline|Total|Total of all reporting groups
1084730|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084731|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084732|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084733|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084734|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084735|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084736|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084737|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084738|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084739|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084740|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084741|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084742|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084743|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084744|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084745|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084746|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084747|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084889|NCT00603564|B2|Baseline|Venturi|O2 administration via a conventional Venturi mask
1084890|NCT00603564|B1|Baseline|CPAP (Continuous Positive Airway Pressure)|CPAP delivered by a helmet
1084891|NCT00603564|P2|Participant Flow|Venturi|O2 administration via a conventional Venturi mask
1084748|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084749|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084750|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084751|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084752|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084753|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084754|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084755|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084756|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084757|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084758|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084759|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084760|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084761|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084762|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084763|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084764|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084765|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084892|NCT00603564|P1|Participant Flow|CPAP (Continuous Positive Airway Pressure)|CPAP delivered by a helmet
1084893|NCT00603564|O2|Outcome|Venturi|O2 administration via a conventional Venturi mask
1084894|NCT00603564|O1|Outcome|CPAP (Continuous Positive Airway Pressure)|CPAP delivered by a helmet
1084766|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084767|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084768|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084769|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084770|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084771|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084772|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084773|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084774|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084775|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084776|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084777|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084778|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084779|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084780|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084781|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084782|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084783|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084895|NCT00603564|O2|Outcome|Venturi|O2 administration via a conventional Venturi mask
1084896|NCT00603564|O1|Outcome|CPAP (Continuous Positive Airway Pressure)|CPAP delivered by a helmet
1084897|NCT00603564|E2|Reported Event|Venturi|O2 administration via a conventional Venturi mask
1084784|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084785|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084786|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084787|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084788|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084789|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084790|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084791|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084792|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084793|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084794|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084795|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084796|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084797|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084798|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084799|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084800|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084801|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084898|NCT00603564|E1|Reported Event|CPAP (Continuous Positive Airway Pressure)|CPAP delivered by a helmet
1084899|NCT00603538|B4|Baseline|Total|Total of all reporting groups
1085118|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
1084802|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084803|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084804|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084805|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084806|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084807|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084808|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084809|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084810|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084811|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084812|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084813|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084814|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084815|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084816|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084817|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084818|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084819|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084970|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
1084971|NCT00603525|O1|Outcome|Placebo|
1084972|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
1084973|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
1084974|NCT00603525|O1|Outcome|Placebo|
1084820|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084821|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084822|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084823|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084824|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084825|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084826|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084827|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084828|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084829|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084830|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084831|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084832|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084833|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084834|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084835|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084836|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084837|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084975|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
1084976|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
1084977|NCT00603525|O1|Outcome|Placebo|
1084978|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
1084979|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
1084838|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084839|NCT00603746|E6|Reported Event|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084840|NCT00603746|E5|Reported Event|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084841|NCT00603746|E4|Reported Event|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084842|NCT00603746|E3|Reported Event|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084843|NCT00603746|E2|Reported Event|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084844|NCT00603746|E1|Reported Event|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
1084845|NCT00603733|B3|Baseline|Total|Total of all reporting groups
1084846|NCT00603733|B2|Baseline|Pentasa®|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet"
1084847|NCT00603733|B1|Baseline|Pentasa® Modified Extended Release|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)"
1084848|NCT00603733|P2|Participant Flow|Pentasa®|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet"
1084849|NCT00603733|P1|Participant Flow|Pentasa® Modified Extended Release|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)"
1084850|NCT00603733|O2|Outcome|Pentasa®|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet"
1084851|NCT00603733|O1|Outcome|Pentasa® Modified Extended Release|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)"
1084852|NCT00603733|O2|Outcome|Pentasa®|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet"
1084853|NCT00603733|O1|Outcome|Pentasa® Modified Extended Release|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)"
1084854|NCT00603733|O2|Outcome|Pentasa®|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet"
1084855|NCT00603733|O1|Outcome|Pentasa® Modified Extended Release|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)"
1084856|NCT00603733|E2|Reported Event|Pentasa®|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet"
1084857|NCT00603733|E1|Reported Event|Pentasa® Modified Extended Release|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)"
1084858|NCT00603642|B3|Baseline|Total|Total of all reporting groups
1084859|NCT00603642|B2|Baseline|Romiplostim|Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg
1084860|NCT00603642|B1|Baseline|Placebo|Placebo administered subcutaneously once weekly for 12 weeks
1084861|NCT00603642|P2|Participant Flow|Romiplostim|Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg
1084862|NCT00603642|P1|Participant Flow|Placebo|Placebo administered subcutaneously once weekly for 12 weeks
1084863|NCT00603642|O2|Outcome|Romiplostim|Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg
1084864|NCT00603642|O1|Outcome|Placebo|Placebo administered subcutaneously once weekly for 12 weeks
1084865|NCT00603642|O2|Outcome|Romiplostim|Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg
1084866|NCT00603642|O1|Outcome|Placebo|Placebo administered subcutaneously once weekly for 12 weeks
1084867|NCT00603642|O2|Outcome|Romiplostim|Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg
1084868|NCT00603642|O1|Outcome|Placebo|Placebo administered subcutaneously once weekly for 12 weeks
1084869|NCT00603642|O2|Outcome|Romiplostim|Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg
1084870|NCT00603642|O1|Outcome|Placebo|Placebo administered subcutaneously once weekly for 12 weeks
1084871|NCT00603642|O2|Outcome|Romiplostim|Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg
1084872|NCT00603642|O1|Outcome|Placebo|Placebo administered subcutaneously once weekly for 12 weeks
1084873|NCT00603642|E2|Reported Event|Romiplostim|
1084874|NCT00603642|E1|Reported Event|Placebo|
1084875|NCT00603590|B3|Baseline|Total|Total of all reporting groups
1084876|NCT00603590|B2|Baseline|Control|Identical placebo tablet
1084877|NCT00603590|B1|Baseline|Polypill|Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)
1084878|NCT00603590|P2|Participant Flow|Control|Identical placebo tablet
1084879|NCT00603590|P1|Participant Flow|Polypill|Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)
1084880|NCT00603590|O2|Outcome|Control|Identical placebo tablet
1085022|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085129|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1084900|NCT00603538|B3|Baseline|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084901|NCT00603538|B2|Baseline|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084902|NCT00603538|B1|Baseline|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084903|NCT00603538|P3|Participant Flow|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084904|NCT00603538|P2|Participant Flow|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084905|NCT00603538|P1|Participant Flow|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084906|NCT00603538|O3|Outcome|CP-751,871 20mg/kg in Combination With Chemotherapy Agents|CP-751,871 20mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy agents; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084907|NCT00603538|O2|Outcome|CP-751,871 10mg/kg in Combination With Chemotherapy Agents|CP-751,871 10mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy agents; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084908|NCT00603538|O1|Outcome|CP-751,871 6mg/kg in Combination With Chemotherapy Agents|CP-751,871 6mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy agents; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084909|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084910|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084911|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084912|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084913|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084914|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084915|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084916|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084917|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084918|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084919|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084920|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084921|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084922|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084923|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084924|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084925|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084926|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084927|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084928|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084929|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084930|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084931|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084932|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084933|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084934|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084935|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084936|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084937|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084938|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084939|NCT00603538|E3|Reported Event|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084940|NCT00603538|E2|Reported Event|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084941|NCT00603538|E1|Reported Event|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
1084942|NCT00603525|B3|Baseline|Total|Total of all reporting groups
1084943|NCT00603525|B2|Baseline|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1084944|NCT00603525|B1|Baseline|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1084945|NCT00603525|P3|Participant Flow|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
1084946|NCT00603525|P2|Participant Flow|Ofatumumab|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
1084947|NCT00603525|P1|Participant Flow|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
1084948|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
1084949|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
1084950|NCT00603525|O1|Outcome|Placebo|
1084951|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
1084952|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
1084953|NCT00603525|O1|Outcome|Placebo|
1084954|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
1084955|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
1084956|NCT00603525|O1|Outcome|Placebo|
1084957|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
1084958|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
1084959|NCT00603525|O1|Outcome|Placebo|
1084960|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
1084961|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
1084962|NCT00603525|O1|Outcome|Placebo|
1084963|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
1084964|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
1084965|NCT00603525|O1|Outcome|Placebo|
1084966|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
1084967|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
1084968|NCT00603525|O1|Outcome|Placebo|
1084969|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
1085023|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085024|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085025|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085026|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085027|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085028|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085029|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085030|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085031|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085032|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085033|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085034|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085035|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085036|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085037|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085038|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085039|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085040|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085041|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085042|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085043|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085044|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085119|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1085045|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085046|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085047|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085048|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085049|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085050|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085051|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085052|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085053|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085054|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085055|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085056|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085057|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085058|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085059|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085060|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085061|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085062|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085063|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085064|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085065|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085066|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085067|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085068|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085069|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
1085120|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
1085070|NCT00603525|E3|Reported Event|Placebo or Ofatumumab 700 mg: Follow-up Period|SAEs and non-serious AEs are reported for participants receiving either placebo or ofatumumab 700 mg in the Follow-up Period. Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
1085128|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
1085071|NCT00603525|E2|Reported Event|Ofatumumab 700 mg: DB and OL Periods|SAEs and non-serious AEs are reported for participants receiving ofatumumab 700 mg in either the DB or OL Period. Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
1085072|NCT00603525|E1|Reported Event|Placebo: DB Period|Serious adverse events (SAEs) and non-serious AEs are reported for participants receiving placebo in the DB Period. Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
1085073|NCT00603512|B6|Baseline|Total|Total of all reporting groups
1085074|NCT00603512|B5|Baseline|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1085075|NCT00603512|B4|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
1085076|NCT00603512|B3|Baseline|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
1085077|NCT00603512|B2|Baseline|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
1085078|NCT00603512|B1|Baseline|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
1085079|NCT00603512|P5|Participant Flow|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1085080|NCT00603512|P4|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
1085081|NCT00603512|P3|Participant Flow|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
1085082|NCT00603512|P2|Participant Flow|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
1085083|NCT00603512|P1|Participant Flow|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
1085084|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1085085|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
1085086|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
1085087|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
1085088|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
1085089|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1085090|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
1085091|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
1085092|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
1085093|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
1085094|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1085095|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
1085096|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
1085097|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
1085098|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
1085099|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1085100|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
1085101|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
1085102|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
1085103|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
1085104|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1085105|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
1085106|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
1085107|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
1085108|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
1085109|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1085110|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
1085111|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
1085112|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
1085113|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
1085114|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1085115|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
1085116|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
1085117|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
1085122|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
1085123|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
1085124|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1085125|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
1085126|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
1085127|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
1085130|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
1085131|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
1085132|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
1085133|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
1085134|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1085135|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
1085136|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
1085137|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
1085138|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
1085139|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1085140|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
1085141|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
1085142|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
1085143|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
1085144|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1085145|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
1085146|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
1085147|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
1085148|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
1085149|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1085150|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
1085151|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
1085152|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
1085153|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
1085154|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1085155|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
1085156|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
1085157|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
1085158|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
1085159|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1085160|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
1085161|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
1085162|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
1085163|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
1085164|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1085165|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
1085166|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
1085167|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
1085168|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
1085169|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1085170|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
1085171|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
1085172|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
1085173|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
1085174|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1085175|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
1085176|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
1085177|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
1085178|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
1085179|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1085180|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
1085181|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
1085182|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
1085183|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
1085184|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1085185|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
1085186|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
1085187|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
1085188|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
1085189|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1085190|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
1085191|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
1085192|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
1085193|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
1085194|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1085195|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
1085196|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
1085197|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
1085198|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
1085199|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1085200|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
1085201|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
1085202|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
1085203|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
1085204|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1085205|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
1085206|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
1085207|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
1085208|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
1085209|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1085210|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
1085211|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
1085212|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
1085213|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
1085214|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1085215|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
1085216|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
1085217|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
1085218|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
1085219|NCT00603512|E5|Reported Event|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
1085220|NCT00603512|E4|Reported Event|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
1085221|NCT00603512|E3|Reported Event|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
1085222|NCT00603512|E2|Reported Event|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
1085223|NCT00603512|E1|Reported Event|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
1085224|NCT00603473|B1|Baseline|Gabapentin|The dosage of oral solution for subjects aged 3 to 12 years was calculated based on their body weight. The dose was titrated for the first 3 days of the treatment period. Subjects aged 3 to 4 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 40 mg/kg/day from Day 3. Subjects aged 5 to 12 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 25 to 35 mg/kg/day from Day 3. Subjects aged 13 to 15 years received gabapentin 600 mg/day on Day 1, 1200 mg/day on Day 2 and 1200 or 1800 mg/day from Day 3. After Day 3, the dose was adjusted if necessary within the range of maintenance doses. The maximum daily dose was 600 mg for Day 1, 1200 mg for Day 2, and 1800 mg for Day 3 and thereafter.
1085225|NCT00603473|P1|Participant Flow|Gabapentin|The dosage of oral solution for subjects aged 3 to 12 years was calculated based on their body weight. The dose was titrated for the first 3 days of the treatment period. Subjects aged 3 to 4 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 40 mg/kg/day from Day 3. Subjects aged 5 to 12 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 25 to 35 mg/kg/day from Day 3. Subjects aged 13 to 15 years received gabapentin 600 mg/day on Day 1, 1200 mg/day on Day 2 and 1200 or 1800 mg/day from Day 3. After Day 3, the dose was adjusted if necessary within the range of maintenance doses. The maximum daily dose was 600 mg for Day 1, 1200 mg for Day 2, and 1800 mg for Day 3 and thereafter.
1085226|NCT00603473|O1|Outcome|Gabapentin|The dosage of oral solution for subjects aged 3 to 12 years was calculated based on their body weight. The dose was titrated for the first 3 days of the treatment period. Subjects aged 3 to 4 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 40 mg/kg/day from Day 3. Subjects aged 5 to 12 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 25 to 35 mg/kg/day from Day 3. Subjects aged 13 to 15 years received gabapentin 600 mg/day on Day 1, 1200 mg/day on Day 2 and 1200 or 1800 mg/day from Day 3. After Day 3, the dose was adjusted if necessary within the range of maintenance doses. The maximum daily dose was 600 mg for Day 1, 1200 mg for Day 2, and 1800 mg for Day 3 and thereafter.
1085227|NCT00603473|O1|Outcome|Gabapentin|The dosage of oral solution for subjects aged 3 to 12 years was calculated based on their body weight. The dose was titrated for the first 3 days of the treatment period. Subjects aged 3 to 4 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 40 mg/kg/day from Day 3. Subjects aged 5 to 12 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 25 to 35 mg/kg/day from Day 3. Subjects aged 13 to 15 years received gabapentin 600 mg/day on Day 1, 1200 mg/day on Day 2 and 1200 or 1800 mg/day from Day 3. After Day 3, the dose was adjusted if necessary within the range of maintenance doses. The maximum daily dose was 600 mg for Day 1, 1200 mg for Day 2, and 1800 mg for Day 3 and thereafter.
1085458|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
1085228|NCT00603473|O1|Outcome|Gabapentin|The dosage of oral solution for subjects aged 3 to 12 years was calculated based on their body weight. The dose was titrated for the first 3 days of the treatment period. Subjects aged 3 to 4 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 40 mg/kg/day from Day 3. Subjects aged 5 to 12 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 25 to 35 mg/kg/day from Day 3. Subjects aged 13 to 15 years received gabapentin 600 mg/day on Day 1, 1200 mg/day on Day 2 and 1200 or 1800 mg/day from Day 3. After Day 3, the dose was adjusted if necessary within the range of maintenance doses. The maximum daily dose was 600 mg for Day 1, 1200 mg for Day 2, and 1800 mg for Day 3 and thereafter.
1085229|NCT00603473|E1|Reported Event|Gabapentin|The dosage of oral solution for subjects aged 3 to 12 years was calculated based on their body weight. The dose was titrated for the first 3 days of the treatment period. Subjects aged 3 to 4 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 40 mg/kg/day from Day 3. Subjects aged 5 to 12 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 25 to 35 mg/kg/day from Day 3. Subjects aged 13 to 15 years received gabapentin 600 mg/day on Day 1, 1200 mg/day on Day 2 and 1200 or 1800 mg/day from Day 3. After Day 3, the dose was adjusted if necessary within the range of maintenance doses. The maximum daily dose was 600 mg for Day 1, 1200 mg for Day 2, and 1800 mg for Day 3 and thereafter.
1085230|NCT00603447|B8|Baseline|Total|Total of all reporting groups
1085231|NCT00603447|B7|Baseline|7: CFZ 20/27 mg/m² + LEN 25 mg|In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
1085232|NCT00603447|B6|Baseline|6: CFZ 20/27 mg/m² + LEN 25 mg|Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
1085233|NCT00603447|B5|Baseline|5: CFZ 20 mg/m² + LEN 25 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
1085234|NCT00603447|B4|Baseline|4: CFZ 20 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
1085235|NCT00603447|B3|Baseline|3: CFZ 15 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
1085236|NCT00603447|B2|Baseline|2: CFZ 15 mg/m² + LEN 15 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
1085237|NCT00603447|B1|Baseline|1: CFZ 15 mg/m² + LEN 10 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
1085238|NCT00603447|P7|Participant Flow|7: CFZ 20/27 mg/m² + LEN 25 mg|In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
1085239|NCT00603447|P6|Participant Flow|6: CFZ 20/27 mg/m² + LEN 25 mg|Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
1085240|NCT00603447|P5|Participant Flow|5: CFZ 20 mg/m² + LEN 25 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
1085241|NCT00603447|P4|Participant Flow|4: CFZ 20 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
1085242|NCT00603447|P3|Participant Flow|3: CFZ 15 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
1085448|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
1085243|NCT00603447|P2|Participant Flow|2: CFZ 15 mg/m² + LEN 15 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
1085244|NCT00603447|P1|Participant Flow|1: CFZ 15 mg/m² + LEN 10 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
1085245|NCT00603447|O6|Outcome|6: CFZ 20/27 mg/m² + LEN 25 mg|Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
1085246|NCT00603447|O5|Outcome|5: CFZ 20 mg/m² + LEN 25 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
1085247|NCT00603447|O4|Outcome|4: CFZ 20 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
1085248|NCT00603447|O3|Outcome|3: CFZ 15 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
1085249|NCT00603447|O2|Outcome|2: CFZ 15 mg/m² + LEN 15 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
1085250|NCT00603447|O1|Outcome|1: CFZ 15 mg/m² + LEN 10 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
1085251|NCT00603447|O7|Outcome|7: CFZ 20/27 mg/m² + LEN 25 mg|In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
1085252|NCT00603447|O6|Outcome|6: CFZ 20/27 mg/m² + LEN 25 mg|Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
1085253|NCT00603447|O5|Outcome|5: CFZ 20 mg/m² + LEN 25 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
1085254|NCT00603447|O4|Outcome|4: CFZ 20 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
1085255|NCT00603447|O3|Outcome|3: CFZ 15 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
1085256|NCT00603447|O2|Outcome|2: CFZ 15 mg/m² + LEN 15 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
1085257|NCT00603447|O1|Outcome|1: CFZ 15 mg/m² + LEN 10 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
1085258|NCT00603447|E7|Reported Event|7: CFZ 20/27 mg/m² + LEN 25 mg|In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
1085259|NCT00603447|E6|Reported Event|6: CFZ 20/27 mg/m² + LEN 25 mg|Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
1085260|NCT00603447|E5|Reported Event|5: CFZ 20 mg/m² + LEN 25 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
1085261|NCT00603447|E4|Reported Event|4: CFZ 20 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
1085262|NCT00603447|E3|Reported Event|3: CFZ 15 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
1085263|NCT00603447|E2|Reported Event|2: CFZ 15 mg/m² + LEN 15 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
1085264|NCT00603447|E1|Reported Event|1: CFZ 15 mg/m² + LEN 10 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
1085265|NCT00603408|B1|Baseline|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
1085266|NCT00603408|P1|Participant Flow|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
1085267|NCT00603408|O1|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
1085268|NCT00603408|O1|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
1085269|NCT00603408|O1|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
1085270|NCT00603408|O1|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
1085271|NCT00603408|O1|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
1085272|NCT00603408|O1|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
1085273|NCT00603408|O1|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
1085274|NCT00603408|O1|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
1085275|NCT00603408|E1|Reported Event|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
1085276|NCT00603382|B7|Baseline|Total|Total of all reporting groups
1085277|NCT00603382|B6|Baseline|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085278|NCT00603382|B5|Baseline|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085279|NCT00603382|B4|Baseline|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085280|NCT00603382|B3|Baseline|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085281|NCT00603382|B2|Baseline|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085282|NCT00603382|B1|Baseline|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085283|NCT00603382|P6|Participant Flow|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085284|NCT00603382|P5|Participant Flow|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085285|NCT00603382|P4|Participant Flow|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085286|NCT00603382|P3|Participant Flow|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085287|NCT00603382|P2|Participant Flow|GW685698X 25 µg OD|Participants received GW685698X 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085288|NCT00603382|P1|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085289|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085290|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085291|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085292|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085293|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085294|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085295|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085296|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085297|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085298|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085299|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085300|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085815|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
1085301|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085302|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085303|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085304|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085305|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085306|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085307|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085308|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085309|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085310|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085311|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085312|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085313|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085314|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085315|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085316|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085317|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085318|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085319|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085320|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085449|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
1085321|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085322|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085323|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085324|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085325|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085326|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085327|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085328|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085329|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085330|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085331|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085332|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085333|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085334|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085335|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085336|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085337|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085338|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085339|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085340|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085450|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
1085341|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085342|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085343|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085344|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085345|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085346|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085347|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085348|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085349|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085350|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085351|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085352|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085353|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085354|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085355|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085356|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085357|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085358|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085359|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085360|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085451|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
1085361|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085362|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085363|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085364|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085365|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085366|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085367|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085368|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085369|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085370|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085371|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085372|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085373|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085374|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085375|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085376|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085377|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085378|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085379|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085380|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085452|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
1085381|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085382|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085383|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085384|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085385|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085386|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085387|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085388|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085389|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085390|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085391|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085392|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085393|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085394|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085395|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085396|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085397|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085398|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085399|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085400|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085453|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
1085401|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085402|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085403|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085404|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085405|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085406|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085407|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085408|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085409|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085410|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085411|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085412|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085413|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085414|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085415|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085416|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085417|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085418|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085419|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085420|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085454|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
1085421|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085422|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085423|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085424|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085425|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085426|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085427|NCT00603382|E6|Reported Event|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085428|NCT00603382|E5|Reported Event|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085429|NCT00603382|E4|Reported Event|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085430|NCT00603382|E3|Reported Event|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085431|NCT00603382|E2|Reported Event|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085432|NCT00603382|E1|Reported Event|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085433|NCT00603304|B3|Baseline|Total|Total of all reporting groups
1085434|NCT00603304|B2|Baseline|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
1085435|NCT00603304|B1|Baseline|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
1085436|NCT00603304|P2|Participant Flow|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
1085437|NCT00603304|P1|Participant Flow|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
1085438|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
1085439|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
1085440|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
1085441|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
1085442|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
1085443|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
1085444|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
1085445|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
1085446|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
1085447|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
1085455|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
1085456|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
1085457|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
1085825|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
1085459|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
1085460|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
1085461|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
1085462|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
1085463|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
1085464|NCT00603304|O2|Outcome|Placebo|One, two, and then three 320 mg placebo gelcaps with dose escalations at 24 and 48 weeks.
1085465|NCT00603304|O1|Outcome|Saw Palmetto|One, two, and then three 320 mg gelcaps with dose escalations at 24 and 48 weeks.
1085466|NCT00603304|O2|Outcome|Placebo|One, two, and then three 320 mg placebo gelcaps with dose escalations at 24 and 48 weeks.
1085467|NCT00603304|O1|Outcome|Saw Palmetto|One, two, and then three 320 mg gelcaps with dose escalations at 24 and 48 weeks.
1085468|NCT00603304|E2|Reported Event|Placebo|One, two, and then three 320 mg placebo gelcaps with dose escalations at 24 and 48 weeks.
1085469|NCT00603304|E1|Reported Event|Saw Palmetto|One, two, and then three 320 mg gelcaps with dose escalations at 24 and 48 weeks.
1085470|NCT00603291|B4|Baseline|Total|Total of all reporting groups
1085471|NCT00603291|B3|Baseline|Matching Placebo|matching placebo tablets
1085472|NCT00603291|B2|Baseline|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
1085473|NCT00603291|B1|Baseline|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
1085474|NCT00603291|P3|Participant Flow|Matching Placebo|matching placebo tablets
1085475|NCT00603291|P2|Participant Flow|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
1085476|NCT00603291|P1|Participant Flow|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
1085477|NCT00603291|O3|Outcome|Matching Placebo|matching placebo tablets
1085478|NCT00603291|O2|Outcome|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
1085479|NCT00603291|O1|Outcome|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
1085480|NCT00603291|O3|Outcome|Matching Placebo|matching placebo tablets
1085481|NCT00603291|O2|Outcome|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
1085482|NCT00603291|O1|Outcome|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
1085483|NCT00603291|E3|Reported Event|Matching Placebo|matching placebo tablets
1085484|NCT00603291|E2|Reported Event|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
1085485|NCT00603291|E1|Reported Event|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
1085486|NCT00603278|B7|Baseline|Total|Total of all reporting groups
1085487|NCT00603278|B6|Baseline|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the NDPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085488|NCT00603278|B5|Baseline|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085489|NCT00603278|B4|Baseline|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085490|NCT00603278|B3|Baseline|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085491|NCT00603278|B2|Baseline|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085492|NCT00603278|B1|Baseline|Placebo|Participants received placebo once daily OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085493|NCT00603278|P6|Participant Flow|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the NDPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085494|NCT00603278|P5|Participant Flow|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085495|NCT00603278|P4|Participant Flow|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085496|NCT00603278|P3|Participant Flow|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085826|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1085497|NCT00603278|P2|Participant Flow|GW685698X 100 µg OD|Participants received GW685698X 100 micrograms (µg) OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085498|NCT00603278|P1|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening from the novel dry powder inhaler (NDPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085499|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085500|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085501|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085502|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085503|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085504|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085505|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085506|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085507|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085508|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085509|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085510|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085511|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085512|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085513|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085514|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085515|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085516|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085517|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085518|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085519|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085520|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085521|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085522|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085523|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085524|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085525|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085526|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085527|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085528|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085529|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085530|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085531|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085532|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085533|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085534|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085668|NCT00603265|O3|Outcome|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
1085535|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085536|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085537|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085538|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085539|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085540|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085541|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085542|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085543|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085544|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085545|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085546|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085547|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085548|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085549|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085550|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085551|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085552|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085553|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085554|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085816|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1085555|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085556|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085557|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085558|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085559|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085560|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085561|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085562|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085563|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085564|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085565|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085566|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085567|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085568|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085569|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085570|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085571|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085572|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085573|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085574|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085817|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
1085575|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085576|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085577|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085578|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085579|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085580|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085581|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085582|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085583|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085584|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085585|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085586|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085587|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085588|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085589|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085590|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085591|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085592|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085593|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085594|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085818|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1085595|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085596|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085597|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085598|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085599|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085600|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085601|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085602|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085603|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085604|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085605|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085606|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085607|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085608|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085609|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085610|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085611|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085612|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085613|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085614|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085819|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
1085615|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085616|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085617|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085618|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085619|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085620|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085621|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085622|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085623|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085624|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085625|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085626|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085627|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085628|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085629|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085630|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085631|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085632|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085633|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085634|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085820|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1085635|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085636|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085637|NCT00603278|E6|Reported Event|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the NDPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085638|NCT00603278|E5|Reported Event|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085639|NCT00603278|E4|Reported Event|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085640|NCT00603278|E3|Reported Event|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085641|NCT00603278|E2|Reported Event|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
1085642|NCT00603278|E1|Reported Event|Placebo|Participants received placebo once daily OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
1085643|NCT00603265|B4|Baseline|Total|Total of all reporting groups
1085644|NCT00603265|B3|Baseline|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
1085645|NCT00603265|B2|Baseline|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
1085646|NCT00603265|B1|Baseline|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
1085647|NCT00603265|P3|Participant Flow|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
1085648|NCT00603265|P2|Participant Flow|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
1085649|NCT00603265|P1|Participant Flow|ADL5859|2 x 50 milligrams (mg) ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
1085650|NCT00603265|O3|Outcome|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
1085651|NCT00603265|O2|Outcome|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
1085652|NCT00603265|O1|Outcome|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
1085653|NCT00603265|O3|Outcome|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
1085654|NCT00603265|O2|Outcome|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
1085655|NCT00603265|O1|Outcome|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
1085656|NCT00603265|O3|Outcome|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
1085657|NCT00603265|O2|Outcome|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
1085658|NCT00603265|O1|Outcome|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
1085659|NCT00603265|O3|Outcome|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
1085660|NCT00603265|O2|Outcome|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
1085661|NCT00603265|O1|Outcome|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
1085662|NCT00603265|O3|Outcome|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
1085663|NCT00603265|O2|Outcome|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
1085664|NCT00603265|O1|Outcome|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
1085665|NCT00603265|O3|Outcome|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
1085666|NCT00603265|O2|Outcome|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
1085667|NCT00603265|O1|Outcome|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
1085669|NCT00603265|O2|Outcome|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
1085670|NCT00603265|O1|Outcome|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
1085671|NCT00603265|E3|Reported Event|Placebo|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
1085672|NCT00603265|E2|Reported Event|Duloxetine|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
1085673|NCT00603265|E1|Reported Event|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
1085674|NCT00603239|B3|Baseline|Total|Total of all reporting groups
1085675|NCT00603239|B2|Baseline|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
1085676|NCT00603239|B1|Baseline|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
1085677|NCT00603239|P2|Participant Flow|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
1085678|NCT00603239|P1|Participant Flow|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
1085679|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
1085680|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
1085681|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
1085682|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
1085683|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
1085684|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
1085685|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
1085686|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
1085687|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
1085688|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
1085689|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
1085690|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
1085691|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
1085692|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
1085693|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
1085694|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
1085695|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
1085696|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
1085697|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
1085698|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
1085699|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
1085700|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
1085701|NCT00603239|E2|Reported Event|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
1085702|NCT00603239|E1|Reported Event|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
1085703|NCT00603187|B1|Baseline|Oral Acyline|20 mg dose of GIPET enhanced oral acyline for 7 days
1085704|NCT00603187|P1|Participant Flow|Oral Acyline|20 mg dose of GIPET enhanced oral acyline for 7 days
1085705|NCT00603187|O1|Outcome|Oral Acyline|20 mg dose of GIPET enhanced oral acyline for 7 days
1085706|NCT00603187|O1|Outcome|Oral Acyline|20 mg dose of GIPET enhanced oral acyline for 7 days
1085707|NCT00603187|O1|Outcome|Oral Acyline|20 mg dose of GIPET enhanced oral acyline for 7 days
1085708|NCT00603187|E1|Reported Event|Oral Acyline|20 mg dose of GIPET enhanced oral acyline for 7 days
1085709|NCT00603044|B3|Baseline|Total|Total of all reporting groups
1085710|NCT00603044|B2|Baseline|No Treatment|Subjects in this arm received no treatment.
1085711|NCT00603044|B1|Baseline|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy~fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
1085712|NCT00603044|P2|Participant Flow|No Treatment|Subjects in this arm received no treatment.
1085749|NCT00602979|E5|Reported Event|McGRATH Video Laryngoscope|"McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy)~McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation"
1085713|NCT00603044|P1|Participant Flow|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy~fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
1085714|NCT00603044|O2|Outcome|No Treatment|Subjects in this arm received no treatment.
1085715|NCT00603044|O1|Outcome|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy~fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
1085716|NCT00603044|O2|Outcome|No Treatment|Subjects in this arm received no treatment.
1085717|NCT00603044|O1|Outcome|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy~fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
1085718|NCT00603044|O2|Outcome|No Treatment|Subjects in this arm received no treatment.
1085719|NCT00603044|O1|Outcome|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy~fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
1085720|NCT00603044|O2|Outcome|No Treatment|Subjects in this arm received no treatment.
1085721|NCT00603044|O1|Outcome|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy~fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
1085722|NCT00603044|O2|Outcome|No Treatment|Subjects in this arm received no treatment.
1085723|NCT00603044|O1|Outcome|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy~fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
1085724|NCT00603044|O2|Outcome|No Treatment|Subjects in this arm received no treatment.
1085725|NCT00603044|O1|Outcome|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy~fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
1085726|NCT00603044|E2|Reported Event|No Treatment|Subjects in this arm received no treatment.
1085727|NCT00603044|E1|Reported Event|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy~fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
1085728|NCT00603018|B1|Baseline|1/Recovered Anorevia|"Recovered anorexia~Fluoxetine: 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day."
1085729|NCT00603018|P1|Participant Flow|Participants Recovered From Anorexia Before + After Fluoxetine|"Participants recovered from anorexia~Fluoxetine: before 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day."
1085730|NCT00603018|O2|Outcome|1/Recovered Anorexia After 8 Weeks of Treatment|"1/Recovered anorexia after 8 weeks of treatment~Fluoxetine: 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day."
1085731|NCT00603018|O1|Outcome|1/Recovered Anorexia Before 8 Weeks of Treatment|"1/Recovered anorexia before 8 weeks of treatment~Baseline"
1085732|NCT00603018|E1|Reported Event|1/Recovered Anorexia|"Recovered anorexia~Fluoxetine: 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day."
1085733|NCT00602979|B6|Baseline|Total|Total of all reporting groups
1085734|NCT00602979|B5|Baseline|McGRATH Video Laryngoscope|"McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy)~McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation"
1085735|NCT00602979|B4|Baseline|GlideScope Video Laryngoscope|"GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy)~GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation"
1085736|NCT00602979|B3|Baseline|Storz DCI Video Laryngoscope|"Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy)~Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation"
1085737|NCT00602979|B2|Baseline|Airtraq Optical Laryngoscope|"Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy)~Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation."
1085738|NCT00602979|B1|Baseline|Macintosh Laryngoscope|"Macintosh laryngoscope (control group/direct laryngoscopy) - current standard~Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation."
1085739|NCT00602979|P5|Participant Flow|McGRATH Video Laryngoscope|"McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy)~McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation"
1085740|NCT00602979|P4|Participant Flow|GlideScope Video Laryngoscope|"GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy)~GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation"
1085741|NCT00602979|P3|Participant Flow|Storz DCI Video Laryngoscope|"Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy)~Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation"
1085742|NCT00602979|P2|Participant Flow|Airtraq Optical Laryngoscope|"Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy)~Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation."
1085743|NCT00602979|P1|Participant Flow|Macintosh Laryngoscope|"Macintosh laryngoscope (control group/direct laryngoscopy) - current standard~Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation."
1085744|NCT00602979|O5|Outcome|McGRATH Video Laryngoscope|"McGRATH® Video Laryngoscope (an experimental group/indirect laryngoscopy)~McGRATH® Video Laryngoscope: Used during laryngoscopy to facilitate intubation"
1085745|NCT00602979|O4|Outcome|GlideScope Video Laryngoscope|"GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy)~GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation"
1085746|NCT00602979|O3|Outcome|Storz DCI Video Laryngoscope|"Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy)~Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation"
1085747|NCT00602979|O2|Outcome|Airtraq Optical Laryngoscope|"Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy)~Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation."
1085748|NCT00602979|O1|Outcome|Macintosh Laryngoscope|"Macintosh laryngoscope (control group/direct laryngoscopy) - current standard~Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation."
1085814|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1085750|NCT00602979|E4|Reported Event|GlideScope Video Laryngoscope|"GlideScope® Video Laryngoscope (an experimental group/indirect laryngoscopy)~GlideScope® Video Laryngoscope: Used during laryngoscopy to facilitate intubation"
1085751|NCT00602979|E3|Reported Event|Storz DCI Video Laryngoscope|"Storz DCI Video Laryngoscope® (an experimental group/indirect laryngoscopy)~Storz DCI Video Laryngoscope®: Used during laryngoscopy to facilitate intubation"
1085752|NCT00602979|E2|Reported Event|Airtraq Optical Laryngoscope|"Airtraq® Optical Laryngoscope (an experimental group/indirect laryngoscopy)~Airtraq® Optical Laryngoscope: Used during laryngoscopy to facilitate intubation."
1085753|NCT00602979|E1|Reported Event|Macintosh Laryngoscope|"Macintosh laryngoscope (control group/direct laryngoscopy) - current standard~Macintosh laryngoscope: Used during laryngoscopy to facilitate intubation."
1085754|NCT00602927|B3|Baseline|Total|Total of all reporting groups
1085755|NCT00602927|B2|Baseline|Varenicline First, Then Placebo|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
1085756|NCT00602927|B1|Baseline|Placebo First, Then Varenicline|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
1085757|NCT00602927|P2|Participant Flow|Varenicline First, Then Placebo|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
1085758|NCT00602927|P1|Participant Flow|Placebo First, Then Varenicline|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
1085759|NCT00602927|O2|Outcome|Varenicline|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
1085760|NCT00602927|O1|Outcome|Placebo|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
1085761|NCT00602927|O2|Outcome|Varenicline|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
1085762|NCT00602927|O1|Outcome|Placebo|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
1085763|NCT00602927|E2|Reported Event|Varenicline First, Then Placebo|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
1085764|NCT00602927|E1|Reported Event|Placebo First, Then Varenicline|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
1085765|NCT00602836|B1|Baseline|PCR-Lenalidomide|Pentostatin, Cyclophosphamide, Rituximab + Lenalidomide
1085766|NCT00602836|P1|Participant Flow|PCR-Lenalidomide|Pentostatin, Cyclophosphamide, Rituximab + Lenalidomide
1085767|NCT00602836|O1|Outcome|PCR-Lenalidomide|Pentostatin, Cyclophosphamide, Rituximab + Lenalidomide
1085768|NCT00602836|E1|Reported Event|PCR-Lenalidomide|Pentostatin, Cyclophosphamide, Rituximab + Lenalidomide
1085769|NCT00602771|B3|Baseline|Total|Total of all reporting groups
1085770|NCT00602771|B2|Baseline|Arm II (Closed to Accrual as of November 2008)|Patients receive 400 mg of oral tipifarnib twice daily on days 1-14 and 200 mg of oral etoposide once daily on days 1-3 and 8-10.
1085771|NCT00602771|B1|Baseline|Arm I|Patients receive 600 mg of oral tipifarnib twice daily on days 1-14 and 100 mg of oral etoposide once daily on days 1-3 and 8-10.
1085772|NCT00602771|P2|Participant Flow|Arm II (Closed to Accrual as of November 2008)|Patients receive 400 mg of oral tipifarnib twice daily on days 1-14 and 200 mg of oral etoposide once daily on days 1-3 and 8-10.
1085773|NCT00602771|P1|Participant Flow|Arm I|Patients receive 600 mg of oral tipifarnib twice daily on days 1-14 and 100 mg of oral etoposide once daily on days 1-3 and 8-10.
1085774|NCT00602771|O2|Outcome|Arm II (Closed to Accrual as of November 2008)|Patients receive 400 mg of oral tipifarnib twice daily on days 1-14 and 200 mg of oral etoposide once daily on days 1-3 and 8-10.
1085775|NCT00602771|O1|Outcome|Arm I|Patients receive 600 mg of oral tipifarnib twice daily on days 1-14 and 100 mg of oral etoposide once daily on days 1-3 and 8-10.
1085776|NCT00602771|E2|Reported Event|Arm II (Closed to Accrual as of November 2008)|Patients receive 400 mg of oral tipifarnib twice daily on days 1-14 and 200 mg of oral etoposide once daily on days 1-3 and 8-10.
1085777|NCT00602771|E1|Reported Event|Arm I|Patients receive 600 mg of oral tipifarnib twice daily on days 1-14 and 100 mg of oral etoposide once daily on days 1-3 and 8-10.
1085778|NCT00602641|B3|Baseline|Total|Total of all reporting groups
1085779|NCT00602641|B2|Baseline|Arm II (mPR-R)|"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression.~melphalan: Given PO~prednisone: Given PO~lenalidomide: Given PO"
1085780|NCT00602641|B1|Baseline|Arm I (MPT-T)|"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression.~melphalan: Given PO~prednisone: Given PO~thalidomide: Given PO"
1085781|NCT00602641|P2|Participant Flow|Arm II (mPR-R)|"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).~INDUCTION THERAPY: Patients receive melphalan 5 mg/m^2 PO and prednisone 100 mg PO daily on days 1-4, and lenalidomide 10 mg PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive lenalidomide 10 mg PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression."
1085782|NCT00602641|P1|Participant Flow|Arm I (MPT-T)|"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).~INDUCTION THERAPY: Patients receive melphalan 9 mg/m^2 PO and prednisone 100 mg PO daily on days 1-4, and thalidomide 100 mg PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive thalidomide 100 mg PO daily and continue in the absence of disease progression."
1085783|NCT00602641|O2|Outcome|Arm II (mPR-R)|"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression."
1085827|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
1085784|NCT00602641|O1|Outcome|Arm I (MPT-T)|"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression."
1085785|NCT00602641|O2|Outcome|Arm II (mPR-R)|"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression."
1085786|NCT00602641|O1|Outcome|Arm I (MPT-T)|"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression."
1085787|NCT00602641|O2|Outcome|Arm II (mPR-R)|"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression."
1085788|NCT00602641|O1|Outcome|Arm I (MPT-T)|"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression."
1085789|NCT00602641|O2|Outcome|Arm II (mPR-R)|"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression."
1085790|NCT00602641|O1|Outcome|Arm I (MPT-T)|"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression."
1085791|NCT00602641|E2|Reported Event|mPR-R|"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression."
1085792|NCT00602641|E1|Reported Event|MPT-T|"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression."
1085793|NCT00602537|B3|Baseline|Total|Total of all reporting groups
1085794|NCT00602537|B2|Baseline|Mood Stabilizer Therapy|Lithium Carbonate: 300 to 2400 mg
1085795|NCT00602537|B1|Baseline|Antidepressant Therapy|Venlafaxine: 75 to 375 mg
1085796|NCT00602537|P2|Participant Flow|Mood Stabilizer Therapy|Lithium Carbonate: 300 to 2400 mg
1085797|NCT00602537|P1|Participant Flow|Antidepressant Therapy|Venlafaxine: 75 to 375 mg
1085798|NCT00602537|O2|Outcome|Mood Stabilizer Therapy|Lithium Carbonate: 300 to 2400 mg
1085799|NCT00602537|O1|Outcome|Antidepressant Therapy|Venlafaxine: 75 to 375 mg
1085800|NCT00602537|O2|Outcome|Mood Stabilizer Therapy|Lithium Carbonate: 300 to 2400 mg
1085801|NCT00602537|O1|Outcome|Antidepressant Therapy|Venlafaxine: 75 to 375 mg
1085802|NCT00602537|E2|Reported Event|Mood Stabilizer Therapy|Lithium Carbonate: 300 to 2400 mg
1085803|NCT00602537|E1|Reported Event|Antidepressant Therapy|Venlafaxine: 75 to 375 mg
1085804|NCT00602472|B3|Baseline|Total|Total of all reporting groups
1085805|NCT00602472|B2|Baseline|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
1085806|NCT00602472|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
1085807|NCT00602472|P2|Participant Flow|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
1085808|NCT00602472|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
1085809|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
1085810|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1085811|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
1085812|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1085813|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
1085821|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
1085822|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1085823|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
1085824|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1085828|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1085829|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
1085830|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1085831|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
1085832|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1085833|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
1085834|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1085835|NCT00602472|E2|Reported Event|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
1085836|NCT00602472|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
1085837|NCT00602459|B5|Baseline|Total|Total of all reporting groups
1085838|NCT00602459|B4|Baseline|Arm D (Rituximab, Fludarabine, Cyclophosphamide, Lenalidomide)|Patients receive the first course of induction therapy as in Arm A or B before being re-assigned to Arm D. Beginning in course 2, patients receive rituximab IV (500 mg/m^2) on day 1 and fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) and cyclophosphamide IV (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) piggyback over 30 minutes on days 1-3. Participants without progression receive consolidation therapy: lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6PO QD on days 1-21 of 28 day cycle.
1085839|NCT00602459|B3|Baseline|Arm C (Rituximab, Fludarabine Phosphate, Cyclophosphamide)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 4 hours on days 1 (50mg/m^2) and 3 (325 mg/m^2) of course 1 and on day 1 (500 mg/m^2) of all subsequent courses. Patients then receive fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) followed by cyclophosphamide (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) IV piggyback over 30 minutes on days 1-3.
1085840|NCT00602459|B2|Baseline|Arm B (Rituximab, Fludarabine Phosphate, Lenalidomide)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle.
1085841|NCT00602459|B1|Baseline|Arm A (Rituximab, Fludarabine Phosphate)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m^2/day IV over 30 minutes or PO on days 1-5.
1085842|NCT00602459|P4|Participant Flow|Arm D (Rituximab, Fludarabine, Cyclophosphamide, Lenalidomide)|Patients receive the first course of induction therapy as in Arm A or B before being re-assigned to Arm D. Beginning in course 2, patients receive rituximab IV (500 mg/m^2) on day 1 and fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) and cyclophosphamide IV (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) piggyback over 30 minutes on days 1-3. Participants without progression receive consolidation therapy: lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6PO QD on days 1-21 of 28 day cycle.
1085843|NCT00602459|P3|Participant Flow|Arm C (Rituximab, Fludarabine Phosphate, Cyclophosphamide)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 4 hours on days 1 (50mg/m^2) and 3 (325 mg/m^2) of course 1 and on day 1 (500 mg/m^2) of all subsequent courses. Patients then receive fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) followed by cyclophosphamide (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) IV piggyback over 30 minutes on days 1-3.
1085844|NCT00602459|P2|Participant Flow|Arm B (Rituximab, Fludarabine Phosphate, Lenalidomide)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle.
1085845|NCT00602459|P1|Participant Flow|Arm A (Rituximab, Fludarabine Phosphate)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m^2/day IV over 30 minutes or PO on days 1-5.
1085846|NCT00602459|O2|Outcome|Arm D, FCR+L in Del(11q22.3)|Patients who have del(11q22.3)receive the first course of induction therapy as in Arm A or B before being re-assigned to Arm D. Beginning in course 2, patients receive rituximab IV (500 mg/m^2) on day 1 and fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) and cyclophosphamide IV (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) piggyback over 30 minutes on days 1-3. Participants without progression receive consolidation therapy: lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6PO QD on days 1-21 of 28 day cycle.
1085863|NCT00602446|O1|Outcome|Deferasirox Treated|Includes patients that were treated with deferasirox for 6 months.
1085864|NCT00602446|E1|Reported Event|Deferasirox Treated|Includes patients that were treated with deferasirox for 6 months.
1085865|NCT00602420|B3|Baseline|Total|Total of all reporting groups
1085847|NCT00602459|O1|Outcome|Arm C2, FCR in Del(11q22.3)|Participants who have del(11q22.3) receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 4 hours on days 1 (50mg/m^2) and 3 (325 mg/m^2) of course 1 and on day 1 (500 mg/m^2) of all subsequent courses. Patients then receive fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) followed by cyclophosphamide (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) IV piggyback over 30 minutes on days 1-3.
1085868|NCT00602420|P2|Participant Flow|Placebo|"Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.~placebo: Oral placebo twice daily for 5-8 days."
1086200|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1085848|NCT00602459|O3|Outcome|Arm C1, FCR in Non-del(11q22.3)|Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 4 hours on days 1 (50mg/m^2) and 3 (325 mg/m^2) of course 1 and on day 1 (500 mg/m^2) of all subsequent courses. Patients then receive fludarabine phosphate (F) (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) followed by cyclophosphamide (C) (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) IV piggyback over 30 minutes on days 1-3.
1085849|NCT00602459|O2|Outcome|Arm B, FR+L in Non-del(11q22.3)|Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate (F) 25 mg/m^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide (L) 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle.
1085850|NCT00602459|O1|Outcome|Arm A, FR in Non-del(11q22.3)|Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate (F) 25 mg/m^2/day IV over 30 minutes or PO on days 1-5.
1085851|NCT00602459|O2|Outcome|Arm D, FCR+L in Del(11q22.3)|Patients who have del(11q22.3)receive the first course of induction therapy as in Arm A or B before being re-assigned to Arm D. Beginning in course 2, patients receive rituximab IV (500 mg/m^2) on day 1 and fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) and cyclophosphamide IV (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) piggyback over 30 minutes on days 1-3. Participants without progression receive consolidation therapy: lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6PO QD on days 1-21 of 28 day cycle.
1085852|NCT00602459|O1|Outcome|Arm C2, FCR in Del(11q22.3)|Participants who have del(11q22.3) receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 4 hours on days 1 (50mg/m^2) and 3 (325 mg/m^2) of course 1 and on day 1 (500 mg/m^2) of all subsequent courses. Patients then receive fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) followed by cyclophosphamide (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) IV piggyback over 30 minutes on days 1-3.
1085853|NCT00602459|O3|Outcome|Arm C1, FCR in Non-del(11q22.3)|Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 4 hours on days 1 (50mg/m^2) and 3 (325 mg/m^2) of course 1 and on day 1 (500 mg/m^2) of all subsequent courses. Patients then receive fludarabine phosphate (F) (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) followed by cyclophosphamide (C) (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) IV piggyback over 30 minutes on days 1-3.
1085854|NCT00602459|O2|Outcome|Arm B, FR+L in Non-del(11q22.3)|Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate (F) 25 mg/m^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide (L) 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle.
1085855|NCT00602459|O1|Outcome|Arm A, FR in Non-del(11q22.3)|Participants, who are non-del(11q22.3), receive induction therapy (every 28 days for up to 6 cycles) of: rituximab (R) IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate (F) 25 mg/m^2/day IV over 30 minutes or PO on days 1-5.
1085856|NCT00602459|E4|Reported Event|Arm D (Rituximab, Fludarabine, Cyclophosphamide, Lenalidomide)|Patients receive the first course of induction therapy as in Arm A or B before being re-assigned to Arm D. Beginning in course 2, patients receive rituximab IV (500 mg/m^2) on day 1 and fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) and cyclophosphamide IV (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) piggyback over 30 minutes on days 1-3. Participants without progression receive consolidation therapy: lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6PO QD on days 1-21 of 28 day cycle.
1085857|NCT00602459|E3|Reported Event|Arm C (Rituximab, Fludarabine Phosphate, Cyclophosphamide)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 4 hours on days 1 (50mg/m^2) and 3 (325 mg/m^2) of course 1 and on day 1 (500 mg/m^2) of all subsequent courses. Patients then receive fludarabine phosphate (age < 70: 25 mg/m^2/day; age >= 70: 20 mg/m^2/day) IV piggyback over 30 minutes or PO (32 mg/m^2/day) followed by cyclophosphamide (age < 70: 250 mg/m^2/day; age >= 70: 150 mg/m^2/day) IV piggyback over 30 minutes on days 1-3.
1085858|NCT00602459|E2|Reported Event|Arm B (Rituximab, Fludarabine Phosphate, Lenalidomide)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle.
1085859|NCT00602459|E1|Reported Event|Arm A (Rituximab, Fludarabine Phosphate)|Participants receive induction therapy (every 28 days for up to 6 cycles) of: Patients receive rituximab IV over 1-4 hours on days 1 (50 mg/m^2), 3 (325 mg/m^2), and 5 (375 mg/m^2) of course 1 and on day 1 (375 mg/m^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m^2/day IV over 30 minutes or PO on days 1-5.
1085860|NCT00602446|B1|Baseline|Deferasirox Treated|Includes patients that were treated with deferasirox for 6 months.
1085861|NCT00602446|P1|Participant Flow|Deferasirox Treated|Includes patients that were treated with deferasirox for 6 months.
1085862|NCT00602446|O1|Outcome|Deferasirox Treated|Includes patients that were treated with deferasirox for 6 months.
1085866|NCT00602420|B2|Baseline|Placebo|"Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.~placebo: Oral placebo twice daily for 5-8 days."
1085867|NCT00602420|B1|Baseline|Naproxen|"Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.~naproxen: Oral naproxen twice daily for 5-8 days."
1086201|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
1085869|NCT00602420|P1|Participant Flow|Naproxen|"Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.~naproxen: Oral naproxen twice daily for 5-8 days."
1085870|NCT00602420|O2|Outcome|Placebo|"Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.~placebo: Oral placebo twice daily for 5-8 days."
1085871|NCT00602420|O1|Outcome|Naproxen|"Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.~naproxen: Oral naproxen twice daily for 5-8 days."
1085872|NCT00602420|E2|Reported Event|Placebo|"Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.~placebo: Oral placebo twice daily for 5-8 days."
1085873|NCT00602420|E1|Reported Event|Naproxen|"Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.~naproxen: Oral naproxen twice daily for 5-8 days."
1085874|NCT00602355|B4|Baseline|Total|Total of all reporting groups
1085875|NCT00602355|B3|Baseline|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone~Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
1085876|NCT00602355|B2|Baseline|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting~Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific “mother-crafting” techniques keyed to the baby’s age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
1085877|NCT00602355|B1|Baseline|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting~Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific “mother-crafting” techniques as those taking sertraline.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
1085878|NCT00602355|P3|Participant Flow|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone~Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
1085879|NCT00602355|P2|Participant Flow|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting~Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific “mother-crafting” techniques keyed to the baby’s age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
1085880|NCT00602355|P1|Participant Flow|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting~Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific “mother-crafting” techniques as those taking sertraline.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
1085881|NCT00602355|O3|Outcome|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone~Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
1085882|NCT00602355|O2|Outcome|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting~Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific “mother-crafting” techniques keyed to the baby’s age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
1085920|NCT00601965|B2|Baseline|Escitalopram + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram"
1085975|NCT00601835|O2|Outcome|United States Td Vaccine Group|Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
1085883|NCT00602355|O1|Outcome|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting~Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific “mother-crafting” techniques as those taking sertraline.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
1086202|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1085884|NCT00602355|O3|Outcome|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone~Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
1085885|NCT00602355|O2|Outcome|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting~Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific “mother-crafting” techniques keyed to the baby’s age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
1085886|NCT00602355|O1|Outcome|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting~Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific “mother-crafting” techniques as those taking sertraline.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
1085887|NCT00602355|O3|Outcome|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone~Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
1085888|NCT00602355|O2|Outcome|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting~Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific “mother-crafting” techniques keyed to the baby’s age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
1085889|NCT00602355|O1|Outcome|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting~Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific “mother-crafting” techniques as those taking sertraline.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
1085890|NCT00602355|O3|Outcome|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone~Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
1085891|NCT00602355|O2|Outcome|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting~Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific “mother-crafting” techniques keyed to the baby’s age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
1085892|NCT00602355|O1|Outcome|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting~Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific “mother-crafting” techniques as those taking sertraline.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
1085893|NCT00602355|O3|Outcome|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone~Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
1085894|NCT00602355|O2|Outcome|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting~Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific “mother-crafting” techniques keyed to the baby’s age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
1085895|NCT00602355|O1|Outcome|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting~Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific “mother-crafting” techniques as those taking sertraline.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
1085896|NCT00602355|E3|Reported Event|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone~Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
1085897|NCT00602355|E2|Reported Event|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting~Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific “mother-crafting” techniques keyed to the baby’s age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
1085898|NCT00602355|E1|Reported Event|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting~Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific “mother-crafting” techniques as those taking sertraline.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
1085899|NCT00602290|B4|Baseline|Total|Total of all reporting groups
1085900|NCT00602290|B3|Baseline|3 - Methylphenidate + Citalopram|"Participants will take a combination of methylphenidate and citalopram for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion."
1085901|NCT00602290|B2|Baseline|2 - Methylphenidate + Placebo|"Participants will take a combination of methylphenidate and placebo for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
1085902|NCT00602290|B1|Baseline|1 - Citalopram + Placebo|"Participants will take a combination of citalopram and placebo for 16 weeks~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
1085903|NCT00602290|P3|Participant Flow|3 - Methylphenidate + Citalopram|"Participants will take a combination of methylphenidate and citalopram for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion."
1085904|NCT00602290|P2|Participant Flow|2 - Methylphenidate + Placebo|"Participants will take a combination of methylphenidate and placebo for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
1085905|NCT00602290|P1|Participant Flow|1 - Citalopram + Placebo|"Participants will take a combination of citalopram and placebo for 16 weeks~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
1085921|NCT00601965|B1|Baseline|Escitalopram + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
1085906|NCT00602290|O3|Outcome|3 - Methylphenidate + Citalopram|"Participants will take a combination of methylphenidate and citalopram for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion."
1085907|NCT00602290|O2|Outcome|2 - Methylphenidate + Placebo|"Participants will take a combination of methylphenidate and placebo for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
1085908|NCT00602290|O1|Outcome|1 - Citalopram + Placebo|"Participants will take a combination of citalopram and placebo for 16 weeks~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
1085909|NCT00602290|E3|Reported Event|3 - Methylphenidate + Citalopram|"Participants will take a combination of methylphenidate and citalopram for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion."
1085910|NCT00602290|E2|Reported Event|2 - Methylphenidate + Placebo|"Participants will take a combination of methylphenidate and placebo for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
1085911|NCT00602290|E1|Reported Event|1 - Citalopram + Placebo|"Participants will take a combination of citalopram and placebo for 16 weeks~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
1085912|NCT00602043|B1|Baseline|First Line Endocrine Therapy for a Stage IV Disease|
1085913|NCT00602043|P1|Participant Flow|Diagnostic (FES)|"Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.~Patients begin clinically indicated endocrine therapy.~Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.~laboratory biomarker analysis: Correlative studies"
1085914|NCT00602043|O2|Outcome|Diagnostic FES: Patients With FES Negative Sites of Disease|"Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.~Patients begin clinically indicated endocrine therapy.~Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.~This group represents patients who had some or all disease sites negative for FES uptake on the baseline diagnostic FES PET scan."
1085915|NCT00602043|O1|Outcome|Diagnostic FES: Average FES SUVmean >1.5, no Negative Sites|"Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.~Patients begin clinically indicated endocrine therapy.~Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.~This group represents patients who had positive FES uptake at all disease sites on the baseline diagnostic FES PET scan.~laboratory biomarker analysis: Correlative studies"
1085916|NCT00602043|E1|Reported Event|Diagnostic (FES)|"Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.~Patients begin clinically indicated endocrine therapy.~Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.~laboratory biomarker analysis: Correlative studies"
1085917|NCT00601965|B5|Baseline|Total|Total of all reporting groups
1085918|NCT00601965|B4|Baseline|Placebo + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram"
1085919|NCT00601965|B3|Baseline|Placebo + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
1085922|NCT00601965|P4|Participant Flow|Placebo + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram"
1085923|NCT00601965|P3|Participant Flow|Placebo + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
1085977|NCT00601835|O2|Outcome|United States Td Vaccine Group|Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
1085924|NCT00601965|P2|Participant Flow|Escitalopram + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram"
1085925|NCT00601965|P1|Participant Flow|Escitalopram + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
1085926|NCT00601965|O4|Outcome|Placebo + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram"
1085927|NCT00601965|O3|Outcome|Placebo + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
1085928|NCT00601965|O2|Outcome|Escitalopram + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram"
1085929|NCT00601965|O1|Outcome|Escitalopram + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
1085930|NCT00601965|O4|Outcome|Placebo + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram"
1085931|NCT00601965|O3|Outcome|Placebo + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
1085932|NCT00601965|O2|Outcome|Escitalopram + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram"
1085933|NCT00601965|O1|Outcome|Escitalopram + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
1085934|NCT00601965|E4|Reported Event|Placebo + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram"
1085935|NCT00601965|E3|Reported Event|Placebo + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
1085936|NCT00601965|E2|Reported Event|Escitalopram + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram"
1085937|NCT00601965|E1|Reported Event|Escitalopram + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
1085938|NCT00601952|B3|Baseline|Total|Total of all reporting groups
1085939|NCT00601952|B2|Baseline|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
1085940|NCT00601952|B1|Baseline|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
1085941|NCT00601952|P2|Participant Flow|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
1085942|NCT00601952|P1|Participant Flow|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
1085943|NCT00601952|O2|Outcome|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
1085944|NCT00601952|O1|Outcome|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
1085945|NCT00601952|E2|Reported Event|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
1085978|NCT00601835|O1|Outcome|Canadian Td Vaccine Group|Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)
1085946|NCT00601952|E1|Reported Event|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
1085947|NCT00601926|B1|Baseline|Bevacizumab|"15 mg/kg over 90 minutes~bevacizumab: 15 mg/kg over 90 minutes every 3 weeks"
1085948|NCT00601926|P1|Participant Flow|Bevacizumab|"15 mg/kg over 90 minutes~bevacizumab: 15 mg/kg over 90 minutes every 3 weeks"
1085949|NCT00601926|O1|Outcome|Bevacizumab|"15 mg/kg over 90 minutes~bevacizumab: 15 mg/kg over 90 minutes every 3 weeks"
1085950|NCT00601926|O1|Outcome|Bevacizumab|"15 mg/kg over 90 minutes~bevacizumab: 15 mg/kg over 90 minutes every 3 weeks"
1085951|NCT00601926|O1|Outcome|Bevacizumab|"15 mg/kg over 90 minutes~bevacizumab: 15 mg/kg over 90 minutes every 3 weeks"
1085952|NCT00601926|E1|Reported Event|Bevacizumab|"15 mg/kg over 90 minutes~bevacizumab: 15 mg/kg over 90 minutes every 3 weeks"
1085953|NCT00601900|B3|Baseline|Total|Total of all reporting groups
1085954|NCT00601900|B2|Baseline|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1085955|NCT00601900|B1|Baseline|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1085956|NCT00601900|P2|Participant Flow|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1085957|NCT00601900|P1|Participant Flow|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1085958|NCT00601900|O2|Outcome|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1085959|NCT00601900|O1|Outcome|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1085960|NCT00601900|O2|Outcome|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1085961|NCT00601900|O1|Outcome|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1085962|NCT00601900|O2|Outcome|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1085963|NCT00601900|O1|Outcome|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1085964|NCT00601900|O2|Outcome|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1085965|NCT00601900|O1|Outcome|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1085966|NCT00601900|O2|Outcome|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1085967|NCT00601900|O1|Outcome|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1085968|NCT00601900|E2|Reported Event|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1085969|NCT00601900|E1|Reported Event|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1085970|NCT00601835|B3|Baseline|Total|Total of all reporting groups
1085971|NCT00601835|B2|Baseline|United States Td Vaccine Group|Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
1085972|NCT00601835|B1|Baseline|Canadian Td Vaccine Group|Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)
1085973|NCT00601835|P2|Participant Flow|United States Td Vaccine Group|Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
1085974|NCT00601835|P1|Participant Flow|Canadian Td Vaccine Group|Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)
1085976|NCT00601835|O1|Outcome|Canadian Td Vaccine Group|Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)
1086203|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
1085979|NCT00601835|O2|Outcome|United States Td Vaccine Group|Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
1085980|NCT00601835|O1|Outcome|Canadian Td Vaccine Group|Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)
1085981|NCT00601835|E2|Reported Event|United States Td Vaccine Group|Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
1085982|NCT00601835|E1|Reported Event|Canadian Td Vaccine Group|Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)
1085983|NCT00601796|B1|Baseline|Combination Immunotherapy|"Vaccine + Cytoxan + ATRA as outlined in Detailed Description~Vaccine Treatment : We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.~All-trans retinoic acid (ATRA) : All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.~Cyclophosphamide : Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells."
1085984|NCT00601796|P1|Participant Flow|Combination Immunotherapy|"Vaccine + Cytoxan + ATRA as outlined in Detailed Description~Vaccine Treatment : We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.~All-trans retinoic acid (ATRA) : All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.~Cyclophosphamide : Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells."
1085985|NCT00601796|O1|Outcome|Combination Immunotherapy|"Vaccine + Cytoxan + ATRA as outlined in Detailed Description~Vaccine Treatment : We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.~All-trans retinoic acid (ATRA) : All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.~Cyclophosphamide : Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells."
1085986|NCT00601796|O1|Outcome|Combination Immunotherapy|"Vaccine + Cytoxan + ATRA as outlined in Detailed Description~Vaccine Treatment : We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.~All-trans retinoic acid (ATRA) : All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.~Cyclophosphamide : Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells."
1085987|NCT00601796|O1|Outcome|Combination Immunotherapy|"Vaccine + Cytoxan + ATRA as outlined in Detailed Description~Vaccine Treatment : We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.~All-trans retinoic acid (ATRA) : All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.~Cyclophosphamide : Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells."
1085988|NCT00601796|O1|Outcome|Combination Immunotherapy|"Vaccine + Cytoxan + ATRA as outlined in Detailed Description~Vaccine Treatment : We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.~All-trans retinoic acid (ATRA) : All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.~Cyclophosphamide : Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells."
1085989|NCT00601796|E1|Reported Event|Combination Immunotherapy|"Vaccine + Cytoxan + ATRA as outlined in Detailed Description~Vaccine Treatment : We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.~All-trans retinoic acid (ATRA) : All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.~Cyclophosphamide : Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells."
1085990|NCT00601731|B13|Baseline|Total|Total of all reporting groups
1085991|NCT00601731|B12|Baseline|Ca Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
1085992|NCT00601731|B11|Baseline|Ca2,4-/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
1086019|NCT00601731|O12|Outcome|Ca Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
1085993|NCT00601731|B10|Baseline|Ca2,4,12-|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
1086065|NCT00601640|B1|Baseline|Arm I|Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90.
1086204|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1085994|NCT00601731|B9|Baseline|Ca2,4+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
1085995|NCT00601731|B8|Baseline|Ca2,4,12+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
1085996|NCT00601731|B7|Baseline|Ca2,4,6+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age
1085997|NCT00601731|B6|Baseline|Ca2,4,6+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
1085998|NCT00601731|B5|Baseline|UK Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
1085999|NCT00601731|B4|Baseline|UK2,4,12-|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
1086000|NCT00601731|B3|Baseline|UK2,4C/12+|UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
1086001|NCT00601731|B2|Baseline|UK2,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
1086002|NCT00601731|B1|Baseline|UK2,3,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
1086003|NCT00601731|P4|Participant Flow|Canada Control|Newly enrolled age-matched subjects that received the complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
1086004|NCT00601731|P3|Participant Flow|Canada Sites|Canadian vaccine group that received primary vaccination with MenACWY (adjuvanted and unadjuvanted) vaccine at 2,4 months of age with 12 month booster or at 2, 4, 6 months with or without a booster vaccination.
1086005|NCT00601731|P2|Participant Flow|UK Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
1086006|NCT00601731|P1|Participant Flow|UK Site|UK vaccine group that received primary vaccine schedule of MenACWY (adjuvanted and unadjuvanted) vaccine at 2, 3 and 4 months with booster at 12 months of age, enrolled at either 40 or 60 months of age into the current study as follow-on participants.
1086007|NCT00601731|O12|Outcome|Ca Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
1086008|NCT00601731|O11|Outcome|Ca2,4-/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
1086009|NCT00601731|O10|Outcome|Ca2,4,12-|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
1086010|NCT00601731|O9|Outcome|Ca2,4+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
1086011|NCT00601731|O8|Outcome|Ca2,4,12+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
1086012|NCT00601731|O7|Outcome|Ca2,4,6+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age
1086013|NCT00601731|O6|Outcome|Ca2,4,6+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
1086014|NCT00601731|O5|Outcome|UK Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
1086015|NCT00601731|O4|Outcome|UK2,4,12-|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
1086016|NCT00601731|O3|Outcome|UK2,4C/12+|UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
1086017|NCT00601731|O2|Outcome|UK2,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
1086018|NCT00601731|O1|Outcome|UK2,3,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
1086020|NCT00601731|O11|Outcome|Ca2,4-/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
1086205|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
1086021|NCT00601731|O10|Outcome|Ca2,4,12-|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
1086022|NCT00601731|O9|Outcome|Ca2,4+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
1086023|NCT00601731|O8|Outcome|Ca2,4,12+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
1086024|NCT00601731|O7|Outcome|Ca2,4,6+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age
1086025|NCT00601731|O6|Outcome|Ca2,4,6+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
1086026|NCT00601731|O5|Outcome|UK Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
1086027|NCT00601731|O4|Outcome|UK2,4,12-|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
1086028|NCT00601731|O3|Outcome|UK2,4C/12+|UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
1086029|NCT00601731|O2|Outcome|UK2,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
1086030|NCT00601731|O1|Outcome|UK2,3,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
1086031|NCT00601731|O12|Outcome|Ca Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
1086032|NCT00601731|O11|Outcome|Ca2,4-/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
1086033|NCT00601731|O10|Outcome|Ca2,4,12-|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
1086034|NCT00601731|O9|Outcome|Ca2,4+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
1086035|NCT00601731|O8|Outcome|Ca2,4,12+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
1086036|NCT00601731|O7|Outcome|Ca2,4,6+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age
1086037|NCT00601731|O6|Outcome|Ca2,4,6+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
1086038|NCT00601731|O5|Outcome|UK Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
1086039|NCT00601731|O4|Outcome|UK2,4,12-|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
1086040|NCT00601731|O3|Outcome|UK2,4C/12+|UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
1086041|NCT00601731|O2|Outcome|UK2,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
1086042|NCT00601731|O1|Outcome|UK2,3,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
1086043|NCT00601731|E12|Reported Event|Ca Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
1086044|NCT00601731|E11|Reported Event|Ca2,4-/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
1086045|NCT00601731|E10|Reported Event|Ca2,4,12-|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
1086046|NCT00601731|E9|Reported Event|Ca2,4+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
1086047|NCT00601731|E8|Reported Event|Ca2,4,12+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
1086048|NCT00601731|E7|Reported Event|Ca2,4,6+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age
1086049|NCT00601731|E6|Reported Event|Ca2,4,6+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
1086050|NCT00601731|E5|Reported Event|UK Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
1086051|NCT00601731|E4|Reported Event|UK2,4,12-|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
1086052|NCT00601731|E3|Reported Event|UK2,4C/12+|UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
1086053|NCT00601731|E2|Reported Event|UK2,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
1086054|NCT00601731|E1|Reported Event|UK2,3,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
1086055|NCT00601718|B1|Baseline|Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy|"Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~rituximab: Given IV~ifosfamide: Given IV~carboplatin: Given IV~etoposide: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies~gene expression analysis: Correlative studies"
1086056|NCT00601718|P1|Participant Flow|Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy|"Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~rituximab: Given IV~ifosfamide: Given IV~carboplatin: Given IV~etoposide: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies~gene expression analysis: Correlative studies"
1086057|NCT00601718|O1|Outcome|Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy|"Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~rituximab: Given IV~ifosfamide: Given IV~carboplatin: Given IV~etoposide: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies~gene expression analysis: Correlative studies"
1086058|NCT00601718|O1|Outcome|Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy|"Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~rituximab: Given IV~ifosfamide: Given IV~carboplatin: Given IV~etoposide: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies~gene expression analysis: Correlative studies"
1086059|NCT00601718|O1|Outcome|Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy|"Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~rituximab: Given IV~ifosfamide: Given IV~carboplatin: Given IV~etoposide: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies~gene expression analysis: Correlative studies"
1086060|NCT00601718|O1|Outcome|Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy|"Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~rituximab: Given IV~ifosfamide: Given IV~carboplatin: Given IV~etoposide: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies~gene expression analysis: Correlative studies"
1086061|NCT00601718|E1|Reported Event|Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy|"Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~rituximab: Given IV~ifosfamide: Given IV~carboplatin: Given IV~etoposide: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies~gene expression analysis: Correlative studies"
1086062|NCT00601640|B4|Baseline|Total|Total of all reporting groups
1086063|NCT00601640|B3|Baseline|Arm III|Patients apply topical eflornithine hydrochloride ointment as in arm I twice daily and topical diclofenac sodium gel as in arm II once daily on days 1-90.
1086064|NCT00601640|B2|Baseline|Arm II|Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
1086066|NCT00601640|P3|Participant Flow|Eflornithine Hydrochloride/Diclofenac Sodium|Patients apply topical Eflornithine hydrochloride ointment as in arm I twice daily and topical Diclofenac sodium gel as in arm II once daily on days 1-90.
1086067|NCT00601640|P2|Participant Flow|Diclofenac Sodium|Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
1086068|NCT00601640|P1|Participant Flow|Eflornithine Hydrochloride|Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90.
1086069|NCT00601640|O3|Outcome|Eflornithine Hydrochloride/Diclofenac Sodium|Patients apply topical Eflornithine hydrochloride ointment as in arm I twice daily and topical Diclofenac sodium gel as in arm II once daily on days 1-90.
1086070|NCT00601640|O2|Outcome|Diclofenac Sodium|Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
1086071|NCT00601640|O1|Outcome|Eflornithine Hydrochloride|Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90.
1086072|NCT00601640|O3|Outcome|Eflornithine Hydrochloride/Diclofenac Sodium|Patients apply topical eflornithine hydrochloride ointment as in arm I twice daily and topical diclofenac sodium gel as in arm II once daily on days 1-90
1086073|NCT00601640|O2|Outcome|Diclofenac Sodium|Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
1086074|NCT00601640|O1|Outcome|Eflornithine Hydrochloride|Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90
1086075|NCT00601640|O3|Outcome|Eflornithine Hydrochloride/Diclofenac Sodium|Patients apply topical Eflornithine hydrochloride ointment as in arm I twice daily and topical Diclofenac sodium gel as in arm II once daily on days 1-90.
1086076|NCT00601640|O2|Outcome|Diclofenac Sodium|Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
1086077|NCT00601640|O1|Outcome|Eflornithine Hydrochloride|Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90.
1086078|NCT00601640|E3|Reported Event|Arm III|Patients apply topical eflornithine hydrochloride ointment as in arm I twice daily and topical diclofenac sodium gel as in arm II once daily on days 1-90.
1086079|NCT00601640|E2|Reported Event|Arm II|Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
1086080|NCT00601640|E1|Reported Event|Arm I|Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90.
1086081|NCT00601627|B1|Baseline|Panitumumab|"Chemotherapy concurrent with radiation:~Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.~4-6 weeks after completion of radiation therapy: 1000 mg/m^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.~Maintenance therapy:~6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles."
1086082|NCT00601627|P1|Participant Flow|Panitumumab|"Chemotherapy concurrent with radiation:~Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.~4-6 weeks after completion of radiation therapy: 1000 mg/m^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.~Maintenance therapy:~6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles."
1086083|NCT00601627|O1|Outcome|Panitumumab|"Chemotherapy concurrent with radiation:~Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.~4-6 weeks after completion of radiation therapy: 1000 mg/m^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.~Maintenance therapy:~6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles."
1086084|NCT00601627|O1|Outcome|Panitumumab|"Chemotherapy concurrent with radiation:~Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.~4-6 weeks after completion of radiation therapy: 1000 mg/m^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.~Maintenance therapy:~6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles."
1086085|NCT00601627|O1|Outcome|Panitumumab|"Chemotherapy concurrent with radiation:~Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.~4-6 weeks after completion of radiation therapy: 1000 mg/m^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.~Maintenance therapy:~6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles."
1086086|NCT00601627|O1|Outcome|Panitumumab|"Chemotherapy concurrent with radiation:~Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.~4-6 weeks after completion of radiation therapy: 1000 mg/m^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.~Maintenance therapy:~6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles."
1086087|NCT00601627|O1|Outcome|Panitumumab|"Chemotherapy concurrent with radiation:~Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.~4-6 weeks after completion of radiation therapy: 1000 mg/m^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.~Maintenance therapy:~6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles."
1086195|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
1108638|NCT00542425|O1|Outcome|Placebo|
1086132|NCT00601458|O3|Outcome|Placebo|Placebo treatment was administered approximately 1 hour prior to surgery. Postoperatively, placebo was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
1086206|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1086207|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
1086088|NCT00601627|O1|Outcome|Panitumumab|"Chemotherapy concurrent with radiation:~Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.~4-6 weeks after completion of radiation therapy: 1000 mg/m^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.~Maintenance therapy:~6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles."
1086089|NCT00601627|E1|Reported Event|Panitumumab|6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles.
1086090|NCT00601523|B3|Baseline|Total|Total of all reporting groups
1086091|NCT00601523|B2|Baseline|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
1086092|NCT00601523|B1|Baseline|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
1086093|NCT00601523|P2|Participant Flow|Patients From 248.636|Pramipexole ER 0.375-4.5 mg. Stratified cohort of patients who had previously completed 248.636 (NCT00558025) and previously received Pramipexole Extended Release (PPX ER), Pramipexole Immediate Release (PPX IR), or Placebo.
1086094|NCT00601523|P1|Participant Flow|Patients From 248.524|Pramipexole ER 0.375-4.5 mg. Stratified cohort of patients who had previously completed 248.524 (NCT00479401) and previously received Pramipexole Extended Release (PPX ER), Pramipexole Immediate Release (PPX IR), or Placebo.
1086095|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
1086096|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
1086097|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
1086098|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
1086099|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
1086100|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
1086101|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
1086102|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
1086103|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
1086104|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
1086105|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
1086106|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
1086107|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
1086108|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
1086109|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
1086110|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
1086111|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
1086112|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
1086113|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
1086114|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
1086115|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
1086116|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
1086117|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
1086118|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
1086119|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
1086120|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
1086121|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
1086122|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
1086123|NCT00601523|E2|Reported Event|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
1086124|NCT00601523|E1|Reported Event|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
1086125|NCT00601458|B4|Baseline|Total|Total of all reporting groups
1086126|NCT00601458|B3|Baseline|Placebo|Placebo treatment was administered approximately 1 hour prior to surgery. Postoperatively, placebo was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
1086127|NCT00601458|B2|Baseline|Naproxen Sodium 550 mg|"Active Comparator: Arm 2: Naproxen sodium 550 mg~Naproxen sodium (550 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium was dosed starting at 12 hours following T=0 and every 12 hours until 36 hours following T=0."
1086128|NCT00601458|B1|Baseline|Pregabalin 300 mg|"Active Comparator: Arm 1: Pregabalin 300 mg~Pregabalin (300 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0."
1086129|NCT00601458|P3|Participant Flow|Placebo|Placebo treatment was administered approximately 1 hour prior to surgery. Postoperatively, placebo was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
1086130|NCT00601458|P2|Participant Flow|Naproxen Sodium 550 mg|"Active Comparator: Arm 2: Naproxen sodium 550 mg~Naproxen sodium (550 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium was dosed starting at 12 hours following T=0 and every 12 hours until 36 hours following T=0."
1086131|NCT00601458|P1|Participant Flow|Pregabalin 300 mg|"Active Comparator: Arm 1: Pregabalin 300 mg~Pregabalin (300 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0."
1086196|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1086133|NCT00601458|O2|Outcome|Naproxen Sodium 550 mg|"Active Comparator: Arm 2: Naproxen sodium 550 mg~Naproxen sodium (550 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium was dosed starting at 12 hours following T=0 and every 12 hours until 36 hours following T=0."
1086134|NCT00601458|O1|Outcome|Pregabalin 300 mg|"Active Comparator: Arm 1: Pregabalin 300 mg~Pregabalin (300 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0."
1086135|NCT00601458|O3|Outcome|Placebo|Placebo treatment was administered approximately 1 hour prior to surgery. Postoperatively, placebo was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
1086136|NCT00601458|O2|Outcome|Naproxen Sodium 550 mg|"Active Comparator: Arm 2: Naproxen sodium 550 mg~Naproxen sodium (550 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium was dosed starting at 12 hours following T=0 and every 12 hours until 36 hours following T=0."
1086137|NCT00601458|O1|Outcome|Pregabalin 300 mg|"Active Comparator: Arm 1: Pregabalin 300 mg~Pregabalin (300 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0."
1086138|NCT00601458|E3|Reported Event|Placebo|Placebo treatment was administered approximately 1 hour prior to surgery. Postoperatively, placebo was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
1086139|NCT00601458|E2|Reported Event|Naproxen Sodium 550 mg|"Active Comparator: Arm 2: Naproxen sodium 550 mg~Naproxen sodium (550 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium was dosed starting at 12 hours following T=0 and every 12 hours until 36 hours following T=0."
1086140|NCT00601458|E1|Reported Event|Pregabalin 300 mg|"Active Comparator: Arm 1: Pregabalin 300 mg~Pregabalin (300 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0."
1086141|NCT00601419|B1|Baseline|Somatropin|Participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
1086142|NCT00601419|P1|Participant Flow|Somatropin|Participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
1086143|NCT00601419|O2|Outcome|Participants Without ACTH Deficiency|Participants without ACTH deficiency taking somatropin for adult growth hormone deficiency according to Japanese package insert.
1086144|NCT00601419|O1|Outcome|Participants With ACTH Deficiency|Participants with ACTH deficiency taking somatropin for adult growth hormone deficiency according to Japanese package insert.
1086145|NCT00601419|O2|Outcome|Female|Female participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
1086146|NCT00601419|O1|Outcome|Male|Male participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
1086147|NCT00601419|O2|Outcome|>=65 Years|Participants older than or equal to 65 years of age while taking somatropin for adult growth hormone deficiency according to Japanese package insert.
1086148|NCT00601419|O1|Outcome|<65 Years|Participants younger than 65 years of age while taking somatropin for adult growth hormone deficiency according to Japanese package insert.
1086149|NCT00601419|O1|Outcome|Somatropin|Participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
1086150|NCT00601419|O4|Outcome|>0.084 mg/kg/Week|Participants taking an initial dose of more than 0.084 mg/kg/week of somatropin for adult growth hormone deficiency according to Japanese package insert.
1086151|NCT00601419|O3|Outcome|>=0.042 mg/kg/Week and <=0.084 mg/kg/Week|Participants taking an initial dose of 0.042 mg/kg/week or more and 0.084 mg/kg/week or less of somatropin for adult growth hormone deficiency according to Japanese package insert.
1086152|NCT00601419|O2|Outcome|>=0.021 mg/kg/Week and <0.042 mg/kg/Week|Participants taking an initial dose of 0.021 mg/kg/week or more and less than 0.042 mg/kg/week of somatropin for adult growth hormone deficiency according to Japanese package insert.
1086153|NCT00601419|O1|Outcome|<0.021 mg/kg/Week|Participants taking an initial dose of less than 0.021 mg/kg/week of somatropin for adult growth hormone deficiency according to Japanese package insert.
1086154|NCT00601419|O2|Outcome|Participants Without Past History of Any Disease|Participants without past history of any disease taking somatropin for adult growth hormone deficiency according to Japanese package insert.
1086155|NCT00601419|O1|Outcome|Participants With Past History of Any Disease|Participants with past history of any disease taking somatropin for adult growth hormone deficiency according to Japanese package insert.
1086156|NCT00601419|O2|Outcome|Participants Without TSH Deficiency|Participants without TSH deficiency taking somatropin for adult growth hormone deficiency according to Japanese package insert.
1086157|NCT00601419|O1|Outcome|Participants With TSH Deficiency|Participants with TSH deficiency taking somatropin for adult growth hormone deficiency according to Japanese package insert.
1086158|NCT00601419|O2|Outcome|Female|Female participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
1086159|NCT00601419|O1|Outcome|Male|Male participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
1086160|NCT00601419|O2|Outcome|>=65 Years|Participants older than or equal to 65 years of age when taking somatropin for adult growth hormone deficiency according to Japanese package insert.
1086161|NCT00601419|O1|Outcome|<65 Years|Participants younger than 65 years of age when taking somatropin for adult growth hormone deficiency according to Japanese package insert.
1086162|NCT00601419|O1|Outcome|Somatropin|Participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
1086163|NCT00601419|O1|Outcome|Somatropin|Participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
1086164|NCT00601419|E1|Reported Event|Somatropin|Participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
1086197|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
1116035|NCT00526227|O1|Outcome|1|
1086198|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1086199|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
1086165|NCT00601367|B1|Baseline|Flibanserin Flexible Dose|"Initial dosage:~Patients were to take one 50 mg flibanserin tablet in the evening.~Subsequent dosage titrations:~Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient.~Flibanserin may have been up-titrated (higher daily dose) at week 4 if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 for safety/tolerability or later in the study at any time following patient contact with the site.~flibanserin flexible dose: Initial dosage: Patients were to take one 50 mg flibanserin tablet in the evening.~Subsequent dosage titrations:~Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the pati"
1086166|NCT00601367|P1|Participant Flow|Flibanserin Flexible Dose|"Initial dosage:~Patients were to take one 50 mg flibanserin tablet in the evening.~Subsequent dosage titrations:~Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient. Flibanserin may have been up-titrated (higher daily dose) at week 4 if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 for safety/tolerability or later in the study at any time following patient contact with the site."
1086167|NCT00601367|O1|Outcome|Flibanserin Flexible Dose|"Initial dosage:~Patients were to take one 50 mg flibanserin tablet in the evening.~Subsequent dosage titrations: Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient. Flibanserin may have been up-titrated (higher daily dose) at week 4 (Visit 3) if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 (visit 3) for safety/tolerability or later in the study at any time following patient contact with the site."
1086168|NCT00601367|E1|Reported Event|Flibanserin Flexible Dose|"Initial dosage:~Patients were to take one 50 mg flibanserin tablet in the evening.~Subsequent dosage titrations:~Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient. Flibanserin may have been up-titrated (higher daily dose) at week 4 (Visit 3) if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 (visit 3) for safety/tolerability or later in the study at any time following patient contact with the site."
1086169|NCT00601354|B3|Baseline|Total|Total of all reporting groups
1086170|NCT00601354|B2|Baseline|OTC Orlistat /Medication Management Alone|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
1086171|NCT00601354|B1|Baseline|OTC Orlistat + Guided Self-help Affect Regulation|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program, plus 12 weekly sessions of guided self-help group psychotherapy
1086172|NCT00601354|P2|Participant Flow|OTC Orlistat /Medication Management Alone|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
1086173|NCT00601354|P1|Participant Flow|OTC Orlistat + Guided Self-help Affect Regulation|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program, plus 12 weekly sessions of guided self-help group psychotherapy
1086174|NCT00601354|O2|Outcome|OTC Orlistat /Medication Management Alone|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
1086175|NCT00601354|O1|Outcome|OTC Orlistat + Guided Self-help Affect Regulation|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program, plus 12 weekly sessions of guided self-help group psychotherapy
1086176|NCT00601354|O2|Outcome|OTC Orlistat /Medication Management Alone|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
1086177|NCT00601354|O1|Outcome|OTC Orlistat + Guided Self-help Affect Regulation|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program, plus 12 weekly sessions of guided self-help group psychotherapy
1086178|NCT00601354|O2|Outcome|OTC Orlistat /Medication Management Alone|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
1086179|NCT00601354|O1|Outcome|OTC Orlistat + Guided Self-help Affect Regulation|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program, plus 12 weekly sessions of guided self-help group psychotherapy
1086180|NCT00601354|E2|Reported Event|OTC Orlistat /Medication Management Alone|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
1086181|NCT00601354|E1|Reported Event|OTC Orlistat + Guided Self-help Affect Regulation|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program, plus 12 weekly sessions of guided self-help group psychotherapy
1086182|NCT00601250|B3|Baseline|Total|Total of all reporting groups
1086183|NCT00601250|B2|Baseline|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
1086184|NCT00601250|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
1086185|NCT00601250|P2|Participant Flow|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
1086186|NCT00601250|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
1086187|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
1086188|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1086189|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
1086190|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1086191|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
1086192|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1086193|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
1086194|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116036|NCT00526227|O1|Outcome|1|
1086208|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1086209|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
1086210|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1086211|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
1086212|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1086213|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
1086214|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1086215|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
1086216|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1086217|NCT00601250|E2|Reported Event|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
1086218|NCT00601250|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
1086219|NCT00601146|B1|Baseline|Low-dose CT Screening|Annual low-dose chest CT screening
1086220|NCT00601146|P1|Participant Flow|Low-dose CT Screening|Annual low-dose chest CT screening
1086221|NCT00601146|O1|Outcome|Low-dose CT Screening|Annual low-dose chest CT screening
1086222|NCT00601146|E1|Reported Event|Low-dose CT Screening|Annual low-dose chest CT screening
1086223|NCT00601107|B5|Baseline|Total|Total of all reporting groups
1086224|NCT00601107|B4|Baseline|Doxercalciferol 7.5 mcg/Day|Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24.
1086225|NCT00601107|B3|Baseline|Doxercalciferol 5 mcg/Day|Doxercalciferol 5 mcg capsules orally once daily up to Week 24.
1086226|NCT00601107|B2|Baseline|Doxercalciferol 2.5 mcg/Day|Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24.
1086227|NCT00601107|B1|Baseline|Placebo|Placebo matching to doxercalciferol capsules orally once daily up to Week 24.
1086228|NCT00601107|P4|Participant Flow|Doxercalciferol 7.5 mcg/Day|Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24.
1086229|NCT00601107|P3|Participant Flow|Doxercalciferol 5 mcg/Day|Doxercalciferol 5 mcg capsules orally once daily up to Week 24.
1086230|NCT00601107|P2|Participant Flow|Doxercalciferol 2.5 mcg/Day|Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24.
1086231|NCT00601107|P1|Participant Flow|Placebo|Placebo matching to doxercalciferol capsules orally once daily up to Week 24.
1086232|NCT00601107|O4|Outcome|Doxercalciferol 7.5 mcg/Day|Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24.
1086233|NCT00601107|O3|Outcome|Doxercalciferol 5 mcg/Day|Doxercalciferol 5 mcg capsules orally once daily up to Week 24.
1086234|NCT00601107|O2|Outcome|Doxercalciferol 2.5 mcg/Day|Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24.
1086235|NCT00601107|O1|Outcome|Placebo|Placebo matching to doxercalciferol capsules orally once daily up to Week 24.
1086236|NCT00601107|O4|Outcome|Doxercalciferol 7.5 mcg/Day|Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24.
1086237|NCT00601107|O3|Outcome|Doxercalciferol 5 mcg/Day|Doxercalciferol 5 mcg capsules orally once daily up to Week 24.
1086238|NCT00601107|O2|Outcome|Doxercalciferol 2.5 mcg/Day|Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24.
1086239|NCT00601107|O1|Outcome|Placebo|Placebo matching to doxercalciferol capsules orally once daily up to Week 24.
1086240|NCT00601107|O4|Outcome|Doxercalciferol 7.5 mcg/Day|Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24.
1086241|NCT00601107|O3|Outcome|Doxercalciferol 5 mcg/Day|Doxercalciferol 5 mcg capsules orally once daily up to Week 24.
1086242|NCT00601107|O2|Outcome|Doxercalciferol 2.5 mcg/Day|Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24.
1086243|NCT00601107|O1|Outcome|Placebo|Placebo matching to doxercalciferol capsules orally once daily up to Week 24.
1086244|NCT00601107|E4|Reported Event|Doxercalciferol 7.5 mcg/Day|Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24.
1086245|NCT00601107|E3|Reported Event|Doxercalciferol 5 mcg/Day|Doxercalciferol 5 mcg capsules orally once daily up to Week 24.
1086246|NCT00601107|E2|Reported Event|Doxercalciferol 2.5 mcg/Day|Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24.
1086247|NCT00601107|E1|Reported Event|Placebo|Placebo matching to doxercalciferol capsules orally once daily up to Week 24.
1086248|NCT00600938|B3|Baseline|Total|Total of all reporting groups
1086249|NCT00600938|B2|Baseline|Core: Deferoxamine (DFO)|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
1086250|NCT00600938|B1|Baseline|Core: Deferasirox (ICL)|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
1086251|NCT00600938|P4|Participant Flow|ICL to DFO (Deferasirox to Deferoxamine)|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
1086252|NCT00600938|P3|Participant Flow|DFO to ICL (Deferoxamine to Deferasirox)|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
1086457|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1116037|NCT00526227|O1|Outcome|1|
1086253|NCT00600938|P2|Participant Flow|Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
1086254|NCT00600938|P1|Participant Flow|Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
1086255|NCT00600938|O1|Outcome|Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
1086256|NCT00600938|O4|Outcome|Extension: ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
1086257|NCT00600938|O3|Outcome|Extension: DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
1086258|NCT00600938|O2|Outcome|Extension: DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
1086259|NCT00600938|O1|Outcome|Extension: ICL to ICL|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
1086260|NCT00600938|O4|Outcome|Extension: ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
1086261|NCT00600938|O3|Outcome|Extension: DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
1086262|NCT00600938|O2|Outcome|Extension: DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
1086263|NCT00600938|O1|Outcome|Extension: ICL to ICL|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
1086264|NCT00600938|O4|Outcome|Extension: ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
1086265|NCT00600938|O3|Outcome|Extension: DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
1086266|NCT00600938|O2|Outcome|Extension: DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
1086267|NCT00600938|O1|Outcome|Extension: ICL to ICL|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
1086268|NCT00600938|O4|Outcome|Extension: ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
1086269|NCT00600938|O3|Outcome|Extension: DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
1086270|NCT00600938|O2|Outcome|Extension: DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
1086271|NCT00600938|O1|Outcome|Extension: ICL to ICL|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
1086272|NCT00600938|O4|Outcome|Extension: ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
1086273|NCT00600938|O3|Outcome|Extension: DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
1086274|NCT00600938|O2|Outcome|Extension: DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
1086275|NCT00600938|O1|Outcome|Extension: ICL to ICL|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
1086276|NCT00600938|O4|Outcome|Extension: ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
1086277|NCT00600938|O3|Outcome|Extension: DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
1086278|NCT00600938|O2|Outcome|Extension: DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
1086279|NCT00600938|O1|Outcome|Extension: ICL to ICL|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
1086280|NCT00600938|O4|Outcome|Extension: ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
1086281|NCT00600938|O3|Outcome|Extension: DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
1086282|NCT00600938|O2|Outcome|Extension: DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
1086283|NCT00600938|O1|Outcome|Extension: ICL to ICL|Patients from core continued and received same dose 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
1086284|NCT00600938|O4|Outcome|Extension: ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
1086285|NCT00600938|O3|Outcome|Extension; DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
1086286|NCT00600938|O2|Outcome|Extension: DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
1086287|NCT00600938|O1|Outcome|Extension : ICL to ICL|Patients from core continued and received same dose 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
1086288|NCT00600938|O1|Outcome|Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
1086289|NCT00600938|O1|Outcome|Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
1086290|NCT00600938|O1|Outcome|Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
1086458|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
1086291|NCT00600938|O2|Outcome|Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 month
1086292|NCT00600938|O1|Outcome|Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
1086293|NCT00600938|O2|Outcome|Core; Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 month
1086294|NCT00600938|O1|Outcome|Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month
1086295|NCT00600938|O2|Outcome|Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 month
1086296|NCT00600938|O1|Outcome|Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month
1086297|NCT00600938|O2|Outcome|Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
1086298|NCT00600938|O1|Outcome|Core; Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month
1086299|NCT00600938|O2|Outcome|Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 month
1086300|NCT00600938|O1|Outcome|Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month
1086301|NCT00600938|O2|Outcome|Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 month
1086302|NCT00600938|O1|Outcome|Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month
1086303|NCT00600938|O2|Outcome|Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
1086304|NCT00600938|O1|Outcome|Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month
1086305|NCT00600938|O2|Outcome|Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 month
1086306|NCT00600938|O1|Outcome|Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month
1086307|NCT00600938|O2|Outcome|Core: Deferoxamine (DFO)|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 months.
1086308|NCT00600938|O1|Outcome|Core: Deferasirox (ICL)|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 months.
1086309|NCT00600938|E6|Reported Event|Extension Phase - ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
1086310|NCT00600938|E5|Reported Event|Extension Phase - DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
1086311|NCT00600938|E4|Reported Event|Extension Phase - DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
1086312|NCT00600938|E3|Reported Event|Extension Phase - ICL to ICL|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
1086313|NCT00600938|E2|Reported Event|Core Phase - DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
1086314|NCT00600938|E1|Reported Event|Core Phase - ICL670|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
1086315|NCT00600886|B3|Baseline|Total|Total of all reporting groups
1086316|NCT00600886|B2|Baseline|Octreotide LAR|Patients in this arm received Octreotide LAR 20 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 10 or 30 mg, respectively. Patients who responded to Octreotide LAR (i.e. the randomized treatment) at the end of the core (Month 12) continued Octreotide LAR treatment in the extension (up to 2 years of treatment). Patients who did not respond to Octreotide LAR at the end of the core (Month 12) were allowed to switch to receive Pasireotide LAR in the extension.
1086317|NCT00600886|B1|Baseline|Pasireotide LAR|Patients in this arm received Pasireotide LAR 40 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 20 or 60 mg, respectively. Patients who responded to Pasireotide LAR (i.e. the randomized treatment) at the end of the core (Month 12), continued Pasireotide LAR treatment in the extension. Patients who did not respond to Pasireotide LAR at the end of the core (Month 12) were allowed to switch to receive Octreotide LAR in the extension.
1086318|NCT00600886|P2|Participant Flow|Octreotide LAR|Patients in this arm received Octreotide LAR 20 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 10 or 30 mg, respectively. Patients who responded to Octreotide LAR (i.e. the randomized treatment) at the end of the core (Month 12) continued Octreotide LAR treatment in the extension (up to 2 years of treatment). Patients who did not respond to Octreotide LAR at the end of the core (Month 12) were allowed to switch to receive Pasireotide LAR in the extension.
1086341|NCT00600886|O1|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
1133216|NCT00478569|O1|Outcome|3 Months|
1086319|NCT00600886|P1|Participant Flow|Pasireotide LAR|Patients in this arm received Pasireotide LAR 40 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 20 or 60 mg, respectively. Patients who responded to Pasireotide LAR (i.e. the randomized treatment) at the end of the core (Month 12), continued Pasireotide LAR treatment in the extension. Patients who did not respond to Pasireotide LAR at the end of the core (Month 12) were allowed to switch to receive Octreotide LAR in the extension.
1086320|NCT00600886|O2|Outcome|Crossed Over to Octreotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
1086345|NCT00600886|O2|Outcome|Octreotide LAR 20 mg|Patients in this arm received Octreotide LAR 20 mg injection prior to PK sample collection.
1086321|NCT00600886|O1|Outcome|Crossed Over to Pasireotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
1086322|NCT00600886|O2|Outcome|Crossed Over to Octreotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
1086323|NCT00600886|O1|Outcome|Crossed Over to Pasireotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
1086324|NCT00600886|O2|Outcome|Crossed Over to Octreotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
1086325|NCT00600886|O1|Outcome|Crossed Over to Pasireotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
1086326|NCT00600886|O2|Outcome|Crossed Over to Octreotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
1086327|NCT00600886|O1|Outcome|Crossed Over to Pasireotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
1086328|NCT00600886|O2|Outcome|Crossed Over to Octreotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
1086329|NCT00600886|O1|Outcome|Crossed Over to Pasireotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
1086330|NCT00600886|O2|Outcome|Crossed Over to Octreotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
1086331|NCT00600886|O1|Outcome|Crossed Over to Pasireotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
1086332|NCT00600886|O2|Outcome|Crossed Over to Octreotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
1086333|NCT00600886|O1|Outcome|Crossed Over to Pasireotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
1086334|NCT00600886|O2|Outcome|Crossed Over to Octreotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
1086335|NCT00600886|O1|Outcome|Crossed Over to Pasireotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
1086336|NCT00600886|O2|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
1086337|NCT00600886|O1|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
1086338|NCT00600886|O2|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
1086339|NCT00600886|O1|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
1086340|NCT00600886|O2|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
1086509|NCT00600743|O2|Outcome|Normal_1mg Drug|Eat normally 1 mg dose drug
1086342|NCT00600886|O2|Outcome|Crossed Over to Octreotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Pasireotide LAR treatment in the core to Octreotide LAR treatment in the extension phase.
1086343|NCT00600886|O1|Outcome|Crossed Over to Pasireotide LAR (Extension)|Includes data from the blinded extension phase (up to Month 26) collected after the crossover time point for patients who crossed over from Octreotide LAR treatment in the core to Pasireotide LAR treatment in the extension phase.
1086344|NCT00600886|O3|Outcome|Octreotide LAR 30 mg|Patients in this arm received Octreotide LAR 30 mg injection prior to PK sample collection.
1086346|NCT00600886|O1|Outcome|Octreotide LAR 10mg|Patients in this arm received Octreotide LAR 10 mg injection prior to PK sample collection.
1086347|NCT00600886|O3|Outcome|Pasireotide LAR 60mg|Patients in this arm received Pasireotide LAR 60 mg injection prior to PK sample collection.
1086348|NCT00600886|O2|Outcome|Pasireotide LAR 40 mg|Patients in this arm received Pasireotide LAR 40 mg injection prior to PK sample collection.
1086349|NCT00600886|O1|Outcome|Pasireotide LAR 20 mg|Patients in this arm received Pasireotide LAR 20 mg injection prior to PK sample collection.
1086350|NCT00600886|O2|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
1086351|NCT00600886|O1|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
1086352|NCT00600886|O2|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
1086353|NCT00600886|O1|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
1086354|NCT00600886|O2|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
1086355|NCT00600886|O1|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
1086356|NCT00600886|O2|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
1086357|NCT00600886|O1|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
1086358|NCT00600886|O2|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
1086359|NCT00600886|O1|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
1086360|NCT00600886|O2|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
1086361|NCT00600886|O1|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
1086362|NCT00600886|O2|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
1086363|NCT00600886|O1|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
1086364|NCT00600886|O2|Outcome|Octreotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment in the extension, only data collected before crossover is included.
1086448|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
1086449|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1086450|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
1086365|NCT00600886|O1|Outcome|Pasireotide LAR (Core & Extension)|Includes data from both blinded core and extension phase (up to Month 26) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment in the extension, only data collected before crossover is included.
1086366|NCT00600886|O2|Outcome|Octreotide LAR (Core)|Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.
1086367|NCT00600886|O1|Outcome|Pasireotide LAR (Core)|Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.
1086368|NCT00600886|O2|Outcome|Octreotide LAR (Core)|Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.
1086369|NCT00600886|O1|Outcome|Pasireotide LAR (Core)|Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.
1086370|NCT00600886|O2|Outcome|Octreotide LAR (Core)|Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.
1086371|NCT00600886|O1|Outcome|Pasireotide LAR (Core)|Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.
1086372|NCT00600886|O2|Outcome|Octreotide LAR (Core)|Includes data from the 12-month blinded core phase for patients randomized to receive Octreotide LAR.
1086373|NCT00600886|O1|Outcome|Pasireotide LAR (Core)|Includes data from the 12-month blinded core phase for patients randomized to receive Pasireotide LAR.
1086374|NCT00600886|E6|Reported Event|Crossed Over to Pasireotide LAR - up to EOS|"Includes all data in the extension phase (up to End-of-study date of 11-Mar-2016) collected after the crossover time point for patients who crossed over from Octreotide LAR in the core to Pasireotide LAR treatment in the extension phase.~Per protocol, patients on Pasireotide LAR could continue to receive open-label Pasireotide LAR after treatment unblinding at Month 26, whereas those on Octreotide LAR were not followed after Month 26."
1086375|NCT00600886|E5|Reported Event|Pasireotide LAR - up to EOS|"Includes data from both core and extension phase (up to End-of-study date of 11-Mar-2016) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment, only data collected before crossover is included.~Per protocol, patients on Pasireotide LAR could continue to receive open-label Pasireotide LAR after treatment unblinding at Month 26, whereas those on Octreotide LAR were not followed after Month 26."
1086376|NCT00600886|E4|Reported Event|Crossed Over to Octreotide LAR - up to 26 Months|Includes all data in the extension phase (up to 26-Month cutoff date of 29-Dec-2011) collected after the crossover time point for patients who crossed over from Pasireotide LAR in the core to Octreotide LAR treatment in the extension phase.
1086377|NCT00600886|E3|Reported Event|Crossed Over to Pasireotide LAR - up to 26 Months|Includes all data in the extension phase (up to 26-Month cutoff date of 29-Dec-2011) collected after the crossover time point for patients who crossed over from Octreotide LAR in the core to Pasireotide LAR treatment in the extension phase.
1086378|NCT00600886|E2|Reported Event|Octreotide LAR - up to 26 Months|Includes data from both blinded core and extension phase (up to Month 26 cutoff date of 29-Dec-2011) for patients who continued the same treatment (Octreotide LAR) as in the core. For patients who switched from blinded Octreotide LAR to Pasireotide LAR treatment, only data collected before crossover is included.
1086379|NCT00600886|E1|Reported Event|Pasireotide LAR - up to 26 Months|Includes data from both blinded core and extension phase (up to Month 26 cutoff date of 29-Dec-2011) for patients who continued the same treatment (Pasireotide LAR) as in the core. For patients who switched from blinded Pasireotide LAR to Octreotide LAR treatment, only data collected before crossover is included.
1086380|NCT00600821|B3|Baseline|Total|Total of all reporting groups
1086381|NCT00600821|B2|Baseline|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
1086382|NCT00600821|B1|Baseline|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
1086383|NCT00600821|P2|Participant Flow|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kilogram (mg/kg) infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
1086384|NCT00600821|P1|Participant Flow|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily (BID) along with infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin area under the concentration-time curve (AUC) of 6 mg*minute/milliliter (mg*min/mL) infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
1086385|NCT00600821|O2|Outcome|Bevacizumab+ Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive Axitinib (AG-013736) BID maintenance therapy.
1086386|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive Axitinib (AG-013736) BID maintenance therapy.
1086451|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1086452|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
1086453|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1086387|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
1086388|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
1086389|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
1086390|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
1086391|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
1086392|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
1086393|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
1086394|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
1086395|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
1086396|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
1086397|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
1086398|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
1086399|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
1086400|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
1086401|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
1086402|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
1086454|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
1086455|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1086456|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
1086403|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
1086404|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
1086405|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
1086406|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
1086407|NCT00600821|E2|Reported Event|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
1086408|NCT00600821|E1|Reported Event|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
1086409|NCT00600756|B3|Baseline|Total|Total of all reporting groups
1086410|NCT00600756|B2|Baseline|Risperidone|Active Comparator – oral, once daily, tablets of 2 mg to 6 mg
1086411|NCT00600756|B1|Baseline|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1086412|NCT00600756|P2|Participant Flow|Risperidone|Active Comparator – oral, once daily, tablets of 2 mg to 6 mg
1086413|NCT00600756|P1|Participant Flow|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1086414|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
1086415|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1086416|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
1086417|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1086418|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
1086419|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1086420|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
1086421|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1086422|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
1086423|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1086424|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
1086425|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1086426|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
1086427|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1086428|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
1086429|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1086430|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
1086431|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1086432|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
1086433|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1086434|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
1086435|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1086436|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
1086437|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1086438|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
1086439|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1086440|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
1086441|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1086442|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
1086443|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1086444|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
1086445|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1086446|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
1086447|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1088307|NCT00594425|P3|Participant Flow|Vehicle PDT|
1086459|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1086460|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
1086461|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1086462|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
1086463|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1086464|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
1086465|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1095200|NCT00575380|O2|Outcome|Vigamox|
1086466|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
1086467|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1086468|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
1086469|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1086470|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
1086471|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1086472|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
1086473|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1086474|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
1086475|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1086476|NCT00600756|E2|Reported Event|Risperidone|Active Comparator – oral, once daily, tablets of 2 mg to 6 mg
1086477|NCT00600756|E1|Reported Event|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
1086478|NCT00600743|B5|Baseline|Total|Total of all reporting groups
1086479|NCT00600743|B4|Baseline|4 MG CCK AGONIST BINGE EATING|Healthy/normal control participants were given both the 4 mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to binge eat as much as they could.
1086480|NCT00600743|B3|Baseline|4 MG CCK AGONIST NORMAL EATING|Healthy/normal control participants were given both the 4mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to eat until they felt normally full.
1086481|NCT00600743|B2|Baseline|2 MG CCK AGONIST NORMAL EATING|Healthy/normal control participants were given both the 2 mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to eat until they felt normally full.
1086482|NCT00600743|B1|Baseline|1 MG CCK AGONIST NORMAL EATING|Healthy/normal control participants were given both the 1 mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to eat until they felt normally full.
1086483|NCT00600743|P4|Participant Flow|4 MG CCK AGONIST BINGE EATING|Healthy/normal control participants were given both the 4 mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to binge eat as much as they could.
1086484|NCT00600743|P3|Participant Flow|4 MG CCK AGONIST NORMAL EATING|Healthy/normal control participants were given both the 4mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to eat until they felt normally full.
1086485|NCT00600743|P2|Participant Flow|2 MG CCK AGONIST NORMAL EATING|Healthy/normal control participants were given both the 2 mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to eat until they felt normally full.
1086486|NCT00600743|P1|Participant Flow|1 MG CCK AGONIST NORMAL EATING|Healthy/normal control participants were given both the 1 mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to eat until they felt normally full.
1086487|NCT00600743|O8|Outcome|Normal_4 mg Dose Placebo|Eat normally 4 mg dose placebo
1086488|NCT00600743|O7|Outcome|Normal_2 mg Dose Placebo|Eat normally 2 mg dose placebo
1086489|NCT00600743|O6|Outcome|Normal 1 mg Dose Placebo|Eat normally 1 mg dose placebo
1086490|NCT00600743|O5|Outcome|Binge - 4mg Placebo|Non-bulimic controls instruction to binge eat - placebo
1086491|NCT00600743|O4|Outcome|Normal_4mg Drug|Eat normally 4 mg dose drug
1086492|NCT00600743|O3|Outcome|Normal_2mg Drug|Eat normally 2 mg dose drug
1086493|NCT00600743|O2|Outcome|Normal_1mg Drug|Eat normally 1 mg dose drug
1086494|NCT00600743|O1|Outcome|Binge_4mg Drug|Non-bulimic controls Instruction to binge eat (7 subjects) drug
1086495|NCT00600743|O8|Outcome|Normal_4mg Placebo|Normal_4mg_dose placebo
1086496|NCT00600743|O7|Outcome|Normal 2mg_placebo|Normal 2mg_dose_placebo
1086497|NCT00600743|O6|Outcome|Normal 1 mg Placebo|Normal 1 mg dose placebo
1086498|NCT00600743|O5|Outcome|Binge - 4mg Plc|binge - 4mg placebo
1086499|NCT00600743|O4|Outcome|Normal_4mg d|Normal_4mg drug
1086500|NCT00600743|O3|Outcome|Normal_2mg d|Normal_2mg drug
1086501|NCT00600743|O2|Outcome|Normal_1mg d|Normal_1mg drug
1086502|NCT00600743|O1|Outcome|Binge_4mg d|Binge_4mg drug
1086503|NCT00600743|O8|Outcome|Normal_4 mg Dose Placebo|Eat normally 4 mg dose placebo
1086504|NCT00600743|O7|Outcome|Normal_2 mg Dose Placebo|Eat normally 2 mg dose placebo
1086505|NCT00600743|O6|Outcome|Normal 1 mg Dose Placebo|Eat normally 1 mg dose placebo
1086506|NCT00600743|O5|Outcome|Binge - 4mg Placebo|Non-bulimic controls instruction to binge eat - placebo
1086507|NCT00600743|O4|Outcome|Normal_4mg Drug|Eat normally 4 mg dose drug
1086508|NCT00600743|O3|Outcome|Normal_2mg Drug|Eat normally 2 mg dose drug
1137278|NCT00467844|O2|Outcome|GTx-024|3 mg
1086510|NCT00600743|O1|Outcome|Binge_4mg Drug|Non-bulimic controls Instruction to binge eat (7 subjects) drug
1086511|NCT00600743|E1|Reported Event|Normal|Normal control group
1086512|NCT00600704|B3|Baseline|Total|Total of all reporting groups
1086513|NCT00600704|B2|Baseline|FREE FLUIDS|Free fluid infusion unless Hb< 6g/dl(allogenic blood use)
1086514|NCT00600704|B1|Baseline|RESTRICTED FLUIDS|Infusion of Hes 130/0.4 up to 500 ml
1086515|NCT00600704|P2|Participant Flow|FREE FLUIDS|Free fluid infusion unless Hb< 6g/dl(allogenic blood use)
1086516|NCT00600704|P1|Participant Flow|RESTRICTED FLUIDS|Infusion of Hes 130/0.4 up to 500 ml
1086971|NCT00599248|B3|Baseline|Total|Total of all reporting groups
1086517|NCT00600704|O2|Outcome|FREE FLUIDS|Free fluid infusion unless Hb< 6g/dl(allogenic blood use)
1086518|NCT00600704|O1|Outcome|RESTRICTED FLUIDS|Infusion of Hes 130/0.4 up to 500 ml
1086519|NCT00600704|E2|Reported Event|FREE FLUIDS|Free fluid infusion unless Hb< 6g/dl(allogenic blood use)
1086520|NCT00600704|E1|Reported Event|RESTRICTED FLUIDS|Infusion of Hes 130/0.4 up to 500 ml
1086521|NCT00600613|B1|Baseline|Patients Going for Treatment of Liver Metastases With RT|Patients going for treatment of liver metastases with radiation therapy.
1086522|NCT00600613|P1|Participant Flow|Patients Going for Treatment of Liver Metastases With RT|Patients going for treatment of liver metastases with radiation therapy.
1086523|NCT00600613|O1|Outcome|Patients Going for Treatment of Liver Metastases With RT|Patients going for treatment of liver metastases with radiation therapy.
1086524|NCT00600613|E1|Reported Event|Patients Going for Treatment of Liver Metastases With RT|Patients going for treatment of liver metastases with radiation therapy.
1086525|NCT00600353|B3|Baseline|Total|Total of all reporting groups
1086526|NCT00600353|B2|Baseline|Group B Lymphoma|Includes patients with Hodgkin's Disease and Non-Hodgkin's lymphoma
1086527|NCT00600353|B1|Baseline|Subjects With Multiple Myeloma|"Group A: Subjects with Multiple Myeloma~Conditioning regimen, over a 7 day period, includes:~Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion~Group B: Subjects with Lymphoma~Conditioning regimen, over a 7 day period, includes: (BEAC)~BCNU 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant"
1086528|NCT00600353|P2|Participant Flow|Group B - Subjects With Relpased Lymphoma|"Group B: Subjects with Lymphoma~Conditioning regimen, over a 7 day period, includes: (BEAC)~carmustin (BCNU) 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant"
1086529|NCT00600353|P1|Participant Flow|Group A - Subjects With Multiple Myeloma|"Group A: Subjects with Multiple Myeloma~Conditioning regimen, over a 7 day period, includes:~Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion"
1086530|NCT00600353|O2|Outcome|Group B - Subjects With Relpased Lymphoma|"Group B: Subjects with Lymphoma~Conditioning regimen, over a 7 day period, includes: (BEAC)~carmustin (BCNU) 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant"
1086531|NCT00600353|O1|Outcome|Group A - Subjects With Multiple Myeloma|"Group A: Subjects with Multiple Myeloma~Conditioning regimen, over a 7 day period, includes:~Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion"
1086532|NCT00600353|O2|Outcome|Group B - Subjects With Relpased Lymphoma|"Group B: Subjects with Lymphoma~Conditioning regimen, over a 7 day period, includes: (BEAC)~carmustin (BCNU) 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant"
1086533|NCT00600353|O1|Outcome|Group A - Subjects With Multiple Myeloma|"Group A: Subjects with Multiple Myeloma~Conditioning regimen, over a 7 day period, includes:~Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion"
1086534|NCT00600353|O2|Outcome|Group B - Subjects With Relpased Lymphoma|"Group B: Subjects with Lymphoma~Conditioning regimen, over a 7 day period, includes: (BEAC)~carmustin (BCNU) 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant"
1086535|NCT00600353|O1|Outcome|Group A - Subjects With Multiple Myeloma|"Group A: Subjects with Multiple Myeloma~Conditioning regimen, over a 7 day period, includes:~Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion"
1086536|NCT00600353|O2|Outcome|Group B - Subjects With Relpased Lymphoma|"Group B: Subjects with Lymphoma~Conditioning regimen, over a 7 day period, includes: (BEAC)~carmustin (BCNU) 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant"
1086537|NCT00600353|O1|Outcome|Group A - Subjects With Multiple Myeloma|"Group A: Subjects with Multiple Myeloma~Conditioning regimen, over a 7 day period, includes:~Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion"
1086621|NCT00600119|B5|Baseline|Placebo 50 mg|Placebo for NKTR-118 50 mg QD, oral treatment
1086622|NCT00600119|B4|Baseline|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
1156459|NCT00420992|O1|Outcome|ALO-01|
1086538|NCT00600353|E2|Reported Event|Patients With Lymphoma|"Group B: Subjects with Lymphoma~Conditioning regimen, over a 7 day period, includes: (BEAC)~BCNU 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant"
1086631|NCT00600119|P1|Participant Flow|Placebo 5 mg|Placebo for NKTR-118 5 mg QD, oral treatment
1086632|NCT00600119|O6|Outcome|NKTR-118 50 mg|NKTR-118 50 mg QD, oral treatment
1086633|NCT00600119|O5|Outcome|Placebo 50 mg|Placebo for NKTR-118 50 mg QD, oral treatment
1086539|NCT00600353|E1|Reported Event|Subjects With Multiple Myeloma|"Group A: Subjects with Multiple Myeloma~Conditioning regimen, over a 7 day period, includes:~Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion"
1086540|NCT00600171|B7|Baseline|Total|Total of all reporting groups
1086541|NCT00600171|B6|Baseline|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086542|NCT00600171|B5|Baseline|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086543|NCT00600171|B4|Baseline|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086544|NCT00600171|B3|Baseline|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086545|NCT00600171|B2|Baseline|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086546|NCT00600171|B1|Baseline|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086547|NCT00600171|P6|Participant Flow|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086548|NCT00600171|P5|Participant Flow|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086549|NCT00600171|P4|Participant Flow|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086550|NCT00600171|P3|Participant Flow|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086551|NCT00600171|P2|Participant Flow|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086552|NCT00600171|P1|Participant Flow|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086553|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086554|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086555|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086556|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086557|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086558|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1169486|NCT00387881|O1|Outcome|Placebo|
1086559|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1087979|NCT00595361|B3|Baseline|Total|Total of all reporting groups
1086560|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086561|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086562|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086563|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086564|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086565|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086566|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086567|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086568|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086569|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086570|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086571|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086572|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086573|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086574|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086575|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086576|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086577|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086578|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086623|NCT00600119|B3|Baseline|Placebo 25 mg|Placebo for NKTR-118 25 mg QD, oral treatment
1086624|NCT00600119|B2|Baseline|NKTR-118 5 mg|NKTR-118 5 mg QD, oral treatment
1086625|NCT00600119|B1|Baseline|Placebo 5 mg|Placebo for NKTR-118 5 mg QD, oral treatment
1086579|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086580|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086581|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086582|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086583|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086584|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086585|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086586|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg µgon non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086587|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086588|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086589|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086590|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086591|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086592|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086593|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086594|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086595|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086596|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086597|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086598|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086626|NCT00600119|P6|Participant Flow|NKTR-118 50 mg|NKTR-118 50 mg QD, oral treatment
1086627|NCT00600119|P5|Participant Flow|Placebo 50 mg|Placebo for NKTR-118 50 mg QD, oral treatment
1088308|NCT00594425|P2|Participant Flow|80 mg/g MAL PDT|
1086599|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086600|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086601|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086602|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086603|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µgon non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086604|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086605|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086606|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086607|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086608|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086609|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086610|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086611|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086612|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086613|NCT00600171|E6|Reported Event|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086614|NCT00600171|E5|Reported Event|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086615|NCT00600171|E4|Reported Event|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086616|NCT00600171|E3|Reported Event|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086617|NCT00600171|E2|Reported Event|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086618|NCT00600171|E1|Reported Event|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
1086619|NCT00600119|B7|Baseline|Total|Total of all reporting groups
1086620|NCT00600119|B6|Baseline|NKTR-118 50 mg|NKTR-118 50 mg QD, oral treatment
1088309|NCT00594425|P1|Participant Flow|40 mg/g MAL PDT|
1086628|NCT00600119|P4|Participant Flow|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
1086629|NCT00600119|P3|Participant Flow|Placebo 25 mg|Placebo for NKTR-118 25 mg QD, oral treatment
1086630|NCT00600119|P2|Participant Flow|NKTR-118 5 mg|NKTR-118 5 mg QD, oral treatment
1095201|NCT00575380|O1|Outcome|Azasite|
1086634|NCT00600119|O4|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
1086635|NCT00600119|O3|Outcome|Placebo 25 mg|Placebo for NKTR-118 25 mg QD, oral treatment
1086636|NCT00600119|O2|Outcome|NKTR-118 5 mg|NKTR-118 5 mg QD, oral treatment
1086637|NCT00600119|O1|Outcome|Placebo 5 mg|Placebo for NKTR-118 5 mg QD, oral treatment
1086638|NCT00600119|O6|Outcome|NKTR-118 50 mg|NKTR-118 50 mg QD, oral treatment
1086639|NCT00600119|O5|Outcome|Placebo 50 mg|Placebo for NKTR-118 50 mg QD, oral treatment
1086640|NCT00600119|O4|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
1086641|NCT00600119|O3|Outcome|Placebo 25 mg|Placebo for NKTR-118 25 mg QD, oral treatment
1086642|NCT00600119|O2|Outcome|NKTR-118 5 mg|NKTR-118 5 mg QD, oral treatment
1086643|NCT00600119|O1|Outcome|Placebo 5 mg|Placebo for NKTR-118 5 mg QD, oral treatment
1086644|NCT00600119|O6|Outcome|NKTR-118 50 mg|NKTR-118 50 mg QD, oral treatment
1086645|NCT00600119|O5|Outcome|Placebo 50 mg|Placebo for NKTR-118 50 mg QD, oral treatment
1086646|NCT00600119|O4|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
1086647|NCT00600119|O3|Outcome|Placebo 25 mg|Placebo for NKTR-118 25 mg QD, oral treatment
1086648|NCT00600119|O2|Outcome|NKTR-118 5 mg|NKTR-118 5 mg QD, oral treatment
1086649|NCT00600119|O1|Outcome|Placebo 5 mg|Placebo for NKTR-118 5 mg QD, oral treatment
1086650|NCT00600119|O6|Outcome|NKTR-118 50 mg|NKTR-118 50 mg QD, oral treatment
1086651|NCT00600119|O5|Outcome|Placebo 50 mg|Placebo for NKTR-118 50 mg QD, oral treatment
1086652|NCT00600119|O4|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
1086653|NCT00600119|O3|Outcome|Placebo 25 mg|Placebo for NKTR-118 25 mg QD, oral treatment
1086654|NCT00600119|O2|Outcome|NKTR-118 5 mg|NKTR-118 5 mg QD, oral treatment
1086655|NCT00600119|O1|Outcome|Placebo 5 mg|Placebo for NKTR-118 5 mg QD, oral treatment
1086656|NCT00600119|E6|Reported Event|Placebo 50 mg|
1086657|NCT00600119|E5|Reported Event|Placebo 5 mg|
1086658|NCT00600119|E4|Reported Event|Placebo 25 mg|
1086659|NCT00600119|E3|Reported Event|NKTR-118 50 mg|
1086660|NCT00600119|E2|Reported Event|NKTR-118 5 mg|
1086661|NCT00600119|E1|Reported Event|NKTR-118 25 mg|
1086662|NCT00600080|B1|Baseline|All Subjects|All subjects crossed over to use each treatment for one week
1086663|NCT00600080|P2|Participant Flow|Nelfilcon A/Etafilcon A|nelfilcon A worn daily during week 1, etafilcon A worn daily for week 2.
1086664|NCT00600080|P1|Participant Flow|Etafilcon A/Nelfilcon A|etafilcon A worn daily during week 1, nelfilcon A worn daily for week 2.
1086665|NCT00600080|O2|Outcome|Etafilcon A|All subjects who wore etafilcon A lenses for one week
1086666|NCT00600080|O1|Outcome|Nelfilcon A|All subjects who wore nelfilcon A lenses for one week
1086667|NCT00600080|O2|Outcome|Etafilcon A|All subjects who wore etafilcon A lenses for one week
1086668|NCT00600080|O1|Outcome|Nelfilcon A|All subjects who wore nelfilcon A lenses for one week
1086669|NCT00600080|O2|Outcome|Etafilcon A|All subjects who wore etafilcon A lenses for one week
1086670|NCT00600080|O1|Outcome|Nelfilcon A|All subjects who wore nelfilcon A lenses for one week
1086671|NCT00600080|O2|Outcome|Etafilcon A|All subjects who wore etafilcon A lenses for one week
1086672|NCT00600080|O1|Outcome|Nelfilcon A|All subjects who wore nelfilcon A lenses for one week
1086673|NCT00600080|E2|Reported Event|Nelfilcon A First Etafilcon A Second|nelfilcon A worn daily during week 1, etafilcon A worn daily for week 2
1086674|NCT00600080|E1|Reported Event|Etafilcon A First Nelfilcon A Second|etafilcon A worn daily during week 1, nelfilcon A worn daily for week 2
1086675|NCT00600067|B3|Baseline|Total|Total of all reporting groups
1086676|NCT00600067|B2|Baseline|Active|PHEN/TPM 15/92
1086677|NCT00600067|B1|Baseline|Placebo|
1086678|NCT00600067|P2|Participant Flow|VI-0521|phentermine 15 mg/topiramate 92 mg
1086679|NCT00600067|P1|Participant Flow|Placebo|
1086680|NCT00600067|O2|Outcome|VI-0521|phentermine 15mg/topiramate 92mg
1086681|NCT00600067|O1|Outcome|Placebo|
1086682|NCT00600067|O2|Outcome|VI-0521|phentermine 15mg/topiramate 92 mg
1086683|NCT00600067|O1|Outcome|Placebo|
1086684|NCT00600067|E2|Reported Event|Active|PHEN/TPM 15/92
1086685|NCT00600067|E1|Reported Event|Placebo|
1086686|NCT00600028|B3|Baseline|Total|Total of all reporting groups
1086687|NCT00600028|B2|Baseline|Placebo First, Then Thalidomide Drug|Placebo was administered in the first intervention period and Thalidomide 50 - 100 mg daily in the second intervention period(After washout period)
1086688|NCT00600028|B1|Baseline|Drug Thalidomide First, Then Placebo|Drug thalidomide 50 - 100 mg daily in the first intervention period and placebo daily in the second intervention period (after washout period)
1086689|NCT00600028|P2|Participant Flow|Placebo First, Then Thalidomide Drug|Placebo was administered in the first interventional period and Thalidomide 50-100mg daily in the second interventional period (after washout period).
1086690|NCT00600028|P1|Participant Flow|Drug Thalidomide First, Then Placebo|Drug Thalidomide 50-100mg daily in the first intervention period and placebo daily in the second intervention period (after washout period)
1086691|NCT00600028|O4|Outcome|Arm Placebo 1st, Thalidomide 2nd (Intervention Thalidomide)|Intervention Thalidomide : thalidomide 50 - 100 mg by mouth daily in the second intervention period
1086692|NCT00600028|O3|Outcome|Arm Placebo 1st, Thalidomide 2nd (Intervention Placebo)|Intervention Placebo : Placebo 50-100 mg by mouth per day in the first intervention period
1086693|NCT00600028|O2|Outcome|Arm Thalidomide 1st, Placebo 2nd (Intervention Placebo)|Intervention Placebo : Placebo 50-100 mg by mouth per day in the second intervention period
1086694|NCT00600028|O1|Outcome|Arm Thalidomide 1st, Placebo 2nd (Intervention Thalidomide)|Intervention Thalidomide : thalidomide 50 - 100 mg by mouth daily in the first intervention period
1086695|NCT00600028|O4|Outcome|Arm Placebo 1st, Thalidomide 2nd (Intervention Thalidomide)|Intervention Thalidomide : thalidomide 50 - 100 mg by mouth daily in the second intervention period
1086696|NCT00600028|O3|Outcome|Arm Placebo 1st, Thalidomide 2nd (Intervention Placebo)|Intervention Placebo : Placebo 50 - 100 mg by mouth daily in the first intervention period
1088326|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1086697|NCT00600028|O2|Outcome|Arm Thalidomide 1st, Placebo 2nd (Intervention Placebo)|Intervention Placebo : Placebo 50-100 mg by mouth per day in the second intervention period
1086698|NCT00600028|O1|Outcome|Arm Thalidomide 1st, Placebo 2nd (Intervention Thalidomide)|Intervention Thalidomide : thalidomide 50 - 100 mg by mouth daily in the first intervention period
1086699|NCT00600028|E2|Reported Event|Placebo|Placebo : Placebo 50-100 mg by mouth per day
1086700|NCT00600028|E1|Reported Event|Thalidomide|Thalidomide : thalidomide 50 - 100 mg by mouth daily
1086701|NCT00600015|B3|Baseline|Total|Total of all reporting groups
1086702|NCT00600015|B2|Baseline|Placebo|Erlotinib + Placebo
1086703|NCT00600015|B1|Baseline|Combination Therapy|Erlotinib + Sorafenib
1086704|NCT00600015|P2|Participant Flow|Placebo|Erlotinib + Placebo
1086705|NCT00600015|P1|Participant Flow|Combination Therapy|Erlotinib + Sorafenib
1086706|NCT00600015|O2|Outcome|Placebo|Erlotinib + Placebo
1086707|NCT00600015|O1|Outcome|Combination Therapy|Erlotinib + Sorafenib
1086708|NCT00600015|O1|Outcome|Combination Therapy|Erlotinib + Sorafenib
1086709|NCT00600015|O2|Outcome|Placebo|Erlotinib + Placebo
1086710|NCT00600015|O1|Outcome|Combination Therapy|Erlotinib + Sorafenib
1086711|NCT00600015|E1|Reported Event|All Study Participants|"Reported SAEs and AEs for all study participants -~Combination Therapy: Erlotinib + Sorafenib Placebo: Erlotinib + Placebo"
1086712|NCT00599924|B8|Baseline|Total|Total of all reporting groups
1086713|NCT00599924|B7|Baseline|25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
1086714|NCT00599924|B6|Baseline|37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
1086715|NCT00599924|B5|Baseline|50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
1086716|NCT00599924|B4|Baseline|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
1086717|NCT00599924|B3|Baseline|50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)|CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086718|NCT00599924|B2|Baseline|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086719|NCT00599924|B1|Baseline|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086720|NCT00599924|P7|Participant Flow|25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
1086721|NCT00599924|P6|Participant Flow|37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
1086722|NCT00599924|P5|Participant Flow|50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
1086723|NCT00599924|P4|Participant Flow|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
1086724|NCT00599924|P3|Participant Flow|50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)|CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086725|NCT00599924|P2|Participant Flow|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086726|NCT00599924|P1|Participant Flow|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086727|NCT00599924|O5|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week rest period, overlapping with 3 cycles of modified FOLFOX6
1086728|NCT00599924|O4|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week rest period, overlapping with 3 cycles of modified FOLFOX6
1086729|NCT00599924|O3|Outcome|50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)|CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086730|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086731|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086732|NCT00599924|O5|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week rest period, overlapping with 3 cycles of modified FOLFOX6
1086733|NCT00599924|O4|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week rest period, overlapping with 3 cycles of modified FOLFOX6
1086734|NCT00599924|O3|Outcome|50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)|CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086972|NCT00599248|B2|Baseline|Placebo Control (DMEM)|"Placebo control~Placebo: Placebo control (DMEM)"
1086735|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086736|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086737|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086738|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086739|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086740|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086741|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086742|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086743|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086744|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086745|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086746|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086747|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086748|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086749|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086750|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086751|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086752|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086753|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086754|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086755|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086756|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086757|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086758|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086759|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086760|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086761|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1087041|NCT00598832|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
1086762|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086763|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086764|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086765|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086766|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086767|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086768|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086769|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086770|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086771|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086772|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086773|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086774|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086775|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086776|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086777|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086778|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086779|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086780|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086781|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086782|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086783|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086784|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086785|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086786|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086787|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086788|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086789|NCT00599924|O7|Outcome|25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
1086790|NCT00599924|O6|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
1087042|NCT00598832|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
1086791|NCT00599924|O5|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
1086792|NCT00599924|O4|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
1171669|NCT00382993|O1|Outcome|Placebo|
1086793|NCT00599924|O3|Outcome|50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)|CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086794|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086795|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086796|NCT00599924|O7|Outcome|25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
1086797|NCT00599924|O6|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
1086798|NCT00599924|O5|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
1086799|NCT00599924|O4|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
1086800|NCT00599924|O3|Outcome|50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)|CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086801|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086802|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086803|NCT00599924|E7|Reported Event|25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
1086804|NCT00599924|E6|Reported Event|37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
1086805|NCT00599924|E5|Reported Event|50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
1086806|NCT00599924|E4|Reported Event|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
1086807|NCT00599924|E3|Reported Event|50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)|CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086808|NCT00599924|E2|Reported Event|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086809|NCT00599924|E1|Reported Event|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
1086810|NCT00599872|B3|Baseline|Total|Total of all reporting groups
1086811|NCT00599872|B2|Baseline|Placebo|Placebo to be administered once daily at 0.0 Units/Amb a 1
1086812|NCT00599872|B1|Baseline|Active|Ragweed allergenic extract administer once daily at 77.3 Units/Amb a 1.
1086813|NCT00599872|P2|Participant Flow|Placebo|Placebo to be administered once daily at 0.0 Units/Amb a 1
1086814|NCT00599872|P1|Participant Flow|Active|Ragweed allergenic extract administer once daily at 77.3 Units/Amb a 1.
1086815|NCT00599872|O2|Outcome|Placebo|Placebo to be administered once daily at 0.0 Units/Amb a 1
1086816|NCT00599872|O1|Outcome|Active|Ragweed allergenic extract administer once daily at 27.6 to 77.3 Units/Amb a 1.
1086817|NCT00599872|O2|Outcome|Placebo|Placebo to be administered once daily at 0.0 Units/Amb a 1
1086818|NCT00599872|O1|Outcome|Active|Ragweed allergenic extract administer once daily at 27.6 to 77.3 Units/Amb a 1.
1086819|NCT00599872|O2|Outcome|Placebo|Placebo to be administered once daily at 0.0 Units/Amb a 1
1086820|NCT00599872|O1|Outcome|Active|Ragweed allergenic extract administer once daily at 77.3 Units/Amb a 1.
1086821|NCT00599872|O2|Outcome|Placebo|"Standardized Ragweed Allergenic Extract Placebo via the sublingual oral route~Placebo: Placebo, sublingual oral"
1086822|NCT00599872|O1|Outcome|Ragweed Allergenic Extract|"Standardized Ragweed Allergenic Extract administered via the sublingual oral route (27.6 to 77.3 Amb a 1 Units)~Standardized Ragweed Allergenic Extract: Standardized Ragweed Allergenic Extract, sublingual oral"
1086823|NCT00599872|O2|Outcome|Placebo|Placebo to be administered once daily at 0.0 Units/Amb a 1
1086824|NCT00599872|O1|Outcome|Active|Ragweed allergenic extract administer once daily at 27.6 to 77.3 Units/Amb a 1.
1086825|NCT00599872|O2|Outcome|Placebo|Placebo to be administered once daily at 0.0 Units/Amb a 1
1086826|NCT00599872|O1|Outcome|Active|Ragweed allergenic extract administer once daily at 26.3 to 77.3 Units/Amb a 1.
1086827|NCT00599872|E2|Reported Event|Placebo|Placebo be administered once daily at 0.0 Units/Amb a 1
1086828|NCT00599872|E1|Reported Event|Ragweed Allergenic Extract|Ragweed Allergenic extract administered once daily at 77.3 Units/Amb a 1.
1088310|NCT00594425|O3|Outcome|Vehicle PDT|
1086829|NCT00599755|B1|Baseline|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
1086830|NCT00599755|P1|Participant Flow|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
1088327|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1086831|NCT00599755|O1|Outcome|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
1086832|NCT00599755|O1|Outcome|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
1086833|NCT00599755|O1|Outcome|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
1086834|NCT00599755|O1|Outcome|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
1086835|NCT00599755|O1|Outcome|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
1086836|NCT00599755|O1|Outcome|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
1086837|NCT00599755|E1|Reported Event|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
1086838|NCT00599521|B3|Baseline|Total|Total of all reporting groups
1086839|NCT00599521|B2|Baseline|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
1086840|NCT00599521|B1|Baseline|Adapalene Lotion 0.1%|once a day for 12 weeks
1086841|NCT00599521|P2|Participant Flow|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
1086842|NCT00599521|P1|Participant Flow|Adapalene Lotion 0.1%|once a day for 12 weeks
1086843|NCT00599521|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
1086844|NCT00599521|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
1086845|NCT00599521|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
1086846|NCT00599521|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
1086847|NCT00599521|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
1086848|NCT00599521|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
1086849|NCT00599521|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
1086850|NCT00599521|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
1086851|NCT00599521|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
1086852|NCT00599521|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
1086853|NCT00599521|E2|Reported Event|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
1086854|NCT00599521|E1|Reported Event|Adapalene Lotion 0.1%|once a day for 12 weeks
1086855|NCT00599339|B1|Baseline|Overall|For this study, 5 groups of patients with different Parkinson’s disease treatments were to be considered. Initial treatments were to include dopaminergic monotherapy with rotigotine, other dopamine agonists (eg, pramipexole, cabergoline, ropinirole), or L-dopa, treatment with L-dopa combined with rotigotine or other dopamine agonists. Treatment was to be performed according to standard medical practice. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
1086856|NCT00599339|P1|Participant Flow|Overall|For this study, 5 groups of patients with different Parkinson's disease treatments were to be considered. Initial treatments were to include dopaminergic monotherapy with rotigotine, other dopamine agonists (eg, pramipexole, cabergoline, ropinirole), or L-dopa, treatment with L-dopa combined with rotigotine or other dopamine agonists. Treatment was to be performed according to standard medical practice. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
1086857|NCT00599339|O2|Outcome|Not Associated With Rotigotine|"A patient was analyzed related to Adverse Events (AEs) not associated with Rotigotine only if during the study he was at risk to develop an AE not associated with Rotigotine.~An adverse event was considered not to be associated with Rotigotine, if no Rotigotine was administered in the 30 days period prior to the onset of the AE."
1086858|NCT00599339|O1|Outcome|Associated With Rotigotine|"A patient was analyzed related to Adverse Events (AEs) associated with Rotigotine only if during the study he was at risk to develop an AE associated with Rotigotine.~An Adverse Event was considered to be associated with Rotigotine if Rotigotine was administered at least once within 30 days prior to the onset of the adverse event. Associated Event does not necessarily mean related to treatment with Rotigotine."
1086859|NCT00599339|O16|Outcome|Not Treated (< 3 Months)|"This group shows all subjects which were not treated for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
1086860|NCT00599339|O15|Outcome|Not Treated (>= 3 Months)|"This group shows all subjects which were not treated for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
1086861|NCT00599339|O14|Outcome|Multiple Dopamine Agonists + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
1086862|NCT00599339|O13|Outcome|Multiple Dopamine Agonists + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
1086968|NCT00599313|O1|Outcome|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
1086969|NCT00599313|O1|Outcome|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
1086970|NCT00599313|E1|Reported Event|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
1086863|NCT00599339|O12|Outcome|Other Dopamine Agonist + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
1086864|NCT00599339|O11|Outcome|Other Dopamine Agonist + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
1086865|NCT00599339|O10|Outcome|Neupro + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
1086866|NCT00599339|O9|Outcome|Neupro + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
1086867|NCT00599339|O8|Outcome|Multiple Dopamine Agonists (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
1086868|NCT00599339|O7|Outcome|Multiple Dopamine Agonists (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
1086869|NCT00599339|O6|Outcome|L-Dopa Monotherapy (< 3 Months)|"This group shows all subjects which were treated with L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
1086870|NCT00599339|O5|Outcome|L-Dopa Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
1086871|NCT00599339|O4|Outcome|Other Dopamine Agonist (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
1086872|NCT00599339|O3|Outcome|Other Dopamine Agonist (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
1086873|NCT00599339|O2|Outcome|Neupro Monotherapy (< 3 Months)|"This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
1086874|NCT00599339|O1|Outcome|Neupro Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
1086875|NCT00599339|O16|Outcome|Not Treated (< 3 Months)|"This group shows all subjects which were not treated for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
1086876|NCT00599339|O15|Outcome|Not Treated (>= 3 Months)|"This group shows all subjects which were not treated for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
1086877|NCT00599339|O14|Outcome|Multiple Dopamine Agonists + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
1086878|NCT00599339|O13|Outcome|Multiple Dopamine Agonists + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
1086963|NCT00599313|P1|Participant Flow|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
1172345|NCT00381303|O1|Outcome|Female|
1086879|NCT00599339|O12|Outcome|Other Dopamine Agonist + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
1086880|NCT00599339|O11|Outcome|Other Dopamine Agonist + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
1086881|NCT00599339|O10|Outcome|Neupro + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
1086882|NCT00599339|O9|Outcome|Neupro + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
1086883|NCT00599339|O8|Outcome|Multiple Dopamine Agonists (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
1086884|NCT00599339|O7|Outcome|Multiple Dopamine Agonists (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
1086885|NCT00599339|O6|Outcome|L-Dopa Monotherapy (< 3 Months)|"This group shows all subjects which were treated with L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
1086886|NCT00599339|O5|Outcome|L-Dopa Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
1086887|NCT00599339|O4|Outcome|Other Dopamine Agonist (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
1086888|NCT00599339|O3|Outcome|Other Dopamine Agonist (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
1086889|NCT00599339|O2|Outcome|Neupro Monotherapy (< 3 Months)|"This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
1086890|NCT00599339|O1|Outcome|Neupro Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
1086891|NCT00599339|O16|Outcome|Not Treated (< 3 Months)|"This group shows all subjects which were not treated for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
1086892|NCT00599339|O15|Outcome|Not Treated (>= 3 Months)|"This group shows all subjects which were not treated for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
1086893|NCT00599339|O14|Outcome|Multiple Dopamine Agonists + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
1086894|NCT00599339|O13|Outcome|Multiple Dopamine Agonists + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
1086964|NCT00599313|O1|Outcome|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
1172346|NCT00381303|O7|Outcome|Other|
1086895|NCT00599339|O12|Outcome|Other Dopamine Agonist + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
1086896|NCT00599339|O11|Outcome|Other Dopamine Agonist + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
1086897|NCT00599339|O10|Outcome|Neupro + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
1086898|NCT00599339|O9|Outcome|Neupro + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
1086899|NCT00599339|O8|Outcome|Multiple Dopamine Agonists (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
1086900|NCT00599339|O7|Outcome|Multiple Dopamine Agonists (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
1086901|NCT00599339|O6|Outcome|L-Dopa Monotherapy (< 3 Months)|"This group shows all subjects which were treated with L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
1086902|NCT00599339|O5|Outcome|L-Dopa Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
1086903|NCT00599339|O4|Outcome|Other Dopamine Agonist (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
1086904|NCT00599339|O3|Outcome|Other Dopamine Agonist (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
1086905|NCT00599339|O2|Outcome|Neupro Monotherapy (< 3 Months)|"This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
1086906|NCT00599339|O1|Outcome|Neupro Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
1086907|NCT00599339|O16|Outcome|Not Treated (< 3 Months)|"This group shows all subjects which were not treated for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
1086908|NCT00599339|O15|Outcome|Not Treated (>= 3 Months)|"This group shows all subjects which were not treated for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
1086909|NCT00599339|O14|Outcome|Multiple Dopamine Agonists + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
1086910|NCT00599339|O13|Outcome|Multiple Dopamine Agonists + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
1086965|NCT00599313|O1|Outcome|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
1172347|NCT00381303|O6|Outcome|Asian|
1086911|NCT00599339|O12|Outcome|Other Dopamine Agonist + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
1086912|NCT00599339|O11|Outcome|Other Dopamine Agonist + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
1086913|NCT00599339|O10|Outcome|Neupro + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
1086914|NCT00599339|O9|Outcome|Neupro + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
1086915|NCT00599339|O8|Outcome|Multiple Dopamine Agonists (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
1086916|NCT00599339|O7|Outcome|Multiple Dopamine Agonists (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
1086917|NCT00599339|O6|Outcome|L-Dopa Monotherapy (< 3 Months)|"This group shows all subjects which were treated with L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
1086918|NCT00599339|O5|Outcome|L-Dopa Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
1086919|NCT00599339|O4|Outcome|Other Dopamine Agonist (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
1086920|NCT00599339|O3|Outcome|Other Dopamine Agonist (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
1086921|NCT00599339|O2|Outcome|Neupro Monotherapy (< 3 Months)|"This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
1086922|NCT00599339|O1|Outcome|Neupro Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
1086923|NCT00599339|O16|Outcome|Not Treated (< 3 Months)|"This group shows all subjects which were not treated for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
1086924|NCT00599339|O15|Outcome|Not Treated (>= 3 Months)|"This group shows all subjects which were not treated for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
1086925|NCT00599339|O14|Outcome|Multiple Dopamine Agonists + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
1086926|NCT00599339|O13|Outcome|Multiple Dopamine Agonists + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
1086966|NCT00599313|O1|Outcome|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
1172348|NCT00381303|O5|Outcome|Hispanic|
1086927|NCT00599339|O12|Outcome|Other Dopamine Agonist + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
1086928|NCT00599339|O11|Outcome|Other Dopamine Agonist + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
1086929|NCT00599339|O10|Outcome|Neupro + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
1086930|NCT00599339|O9|Outcome|Neupro + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
1086931|NCT00599339|O8|Outcome|Multiple Dopamine Agonists (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
1086932|NCT00599339|O7|Outcome|Multiple Dopamine Agonists (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
1086933|NCT00599339|O6|Outcome|L-Dopa Monotherapy (< 3 Months)|"This group shows all subjects which were treated with L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
1086934|NCT00599339|O5|Outcome|L-Dopa Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
1086935|NCT00599339|O4|Outcome|Other Dopamine Agonist (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
1086936|NCT00599339|O3|Outcome|Other Dopamine Agonist (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
1086937|NCT00599339|O2|Outcome|Neupro Monotherapy (< 3 Months)|"This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
1086938|NCT00599339|O1|Outcome|Neupro Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
1086939|NCT00599339|O16|Outcome|Not Treated (< 3 Months)|"This group shows all subjects which were not treated for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
1086940|NCT00599339|O15|Outcome|Not Treated (>= 3 Months)|"This group shows all subjects which were not treated for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
1086941|NCT00599339|O14|Outcome|Multiple Dopamine Agonists + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
1086942|NCT00599339|O13|Outcome|Multiple Dopamine Agonists + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
1086967|NCT00599313|O1|Outcome|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
1172349|NCT00381303|O4|Outcome|Caucasian|
1086943|NCT00599339|O12|Outcome|Other Dopamine Agonist + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
1086944|NCT00599339|O11|Outcome|Other Dopamine Agonist + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
1086945|NCT00599339|O10|Outcome|Neupro + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
1086946|NCT00599339|O9|Outcome|Neupro + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
1086947|NCT00599339|O8|Outcome|Multiple Dopamine Agonists (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
1086948|NCT00599339|O7|Outcome|Multiple Dopamine Agonists (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
1086949|NCT00599339|O6|Outcome|L-Dopa Monotherapy (< 3 Months)|"This group shows all subjects which were treated with L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
1086950|NCT00599339|O5|Outcome|L-Dopa Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
1086951|NCT00599339|O4|Outcome|Other Dopamine Agonist (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
1086952|NCT00599339|O3|Outcome|Other Dopamine Agonist (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
1086953|NCT00599339|O2|Outcome|Neupro Monotherapy (< 3 Months)|"This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
1086954|NCT00599339|O1|Outcome|Neupro Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
1086955|NCT00599339|E2|Reported Event|Not Associated With Rotigotine|"A patient was analyzed related to Adverse Events (AEs) not associated with Rotigotine only if during the study he was at risk to develop an AE not associated with Rotigotine.~An adverse event was considered not to be associated with Rotigotine, if no Rotigotine was administered in the 30 days period prior to the onset of the AE."
1086956|NCT00599339|E1|Reported Event|Associated With Rotigotine|"A patient was analyzed related to Adverse Events (AEs) associated with Rotigotine only if during the study he was at risk to develop an AE associated with Rotigotine.~An Adverse Event was considered to be associated with Rotigotine if Rotigotine was administered at least once within 30 days prior to the onset of the adverse event. Associated Event does not necessarily mean related to treatment with Rotigotine."
1086957|NCT00599326|B1|Baseline|Deferasirox|Deferasirox : 250 mg of deferasirox once daily for 6 months with an increase to 500 mg/d after 2 months if new blisters continued to develop.
1086958|NCT00599326|P1|Participant Flow|Deferasirox|Deferasirox : 250 mg of deferasirox once daily for 6 months with an increase to 500 mg/d after 2 months if new blisters continued to develop.
1086959|NCT00599326|O1|Outcome|Deferasirox|Deferasirox : 250 mg of deferasirox once daily for 6 months with an increase to 500 mg/d after 2 months if new blisters continued to develop.
1086960|NCT00599326|O1|Outcome|Deferasirox|Deferasirox : 250 mg of deferasirox once daily for 6 months with an increase to 500 mg/d after 2 months if new blisters continued to develop.
1086961|NCT00599326|E1|Reported Event|Deferasirox|Deferasirox : 250 mg of deferasirox once daily for 6 months with an increase to 500 mg/d after 2 months if new blisters continued to develop.
1086962|NCT00599313|B1|Baseline|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
1086973|NCT00599248|B1|Baseline|Active Treatment (TG-C)|"TissueGene-C at 3x10e6, 1x10e7 or, 3x10e7 cells/joint~TissueGene-C: TissueGene-C at 3x10e6, 1x10e7 or 3x10e7 cells/joint to be administered by intra-articular injection"
1086974|NCT00599248|P2|Participant Flow|Plcebo Control (DMEM)|"Placebo control~Placebo: Placebo control (DMEM)"
1086975|NCT00599248|P1|Participant Flow|Active Treatment (TG-C)|"TissueGene-C at 3x10e6, 1x10e7 or, 3x10e7 cells/joint~TissueGene-C: TissueGene-C at 3x10e6, 1x10e7 or 3x10e7 cells/joint to be administered by intra-articular injection"
1086976|NCT00599248|O2|Outcome|Placebo Control (DMEM)|"Placebo control~Placebo: Placebo control (DMEM)"
1086977|NCT00599248|O1|Outcome|Active Treatment (TG-C)|"TissueGene-C at 3x10e6, 1x10e7 or, 3x10e7 cells/joint~TissueGene-C: TissueGene-C at 3x10e6, 1x10e7 or 3x10e7 cells/joint to be administered by intra-articular injection"
1086978|NCT00599248|O2|Outcome|Placebo Control (DMEM)|"Placebo control~Placebo: Placebo control (DMEM)"
1086979|NCT00599248|O1|Outcome|Active Treatment (TG-C)|"TissueGene-C at 3x10e6, 1x10e7 or, 3x10e7 cells/joint~TissueGene-C: TissueGene-C at 3x10e6, 1x10e7 or 3x10e7 cells/joint to be administered by intra-articular injection"
1086980|NCT00599248|E2|Reported Event|Placebo Control (DMEM)|"Placebo control~Placebo: Placebo control (DMEM)"
1086981|NCT00599248|E1|Reported Event|Active Treatment (TG-C)|"TissueGene-C at 3x10e6, 1x10e7 or, 3x10e7 cells/joint~TissueGene-C: TissueGene-C at 3x10e6, 1x10e7 or 3x10e7 cells/joint to be administered by intra-articular injection"
1086982|NCT00599196|B1|Baseline|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
1086983|NCT00599196|P1|Participant Flow|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
1086984|NCT00599196|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
1086985|NCT00599196|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
1086986|NCT00599196|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
1086987|NCT00599196|E1|Reported Event|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
1086988|NCT00599131|B1|Baseline|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.~On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.~Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
1086989|NCT00599131|P1|Participant Flow|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.~On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.~Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
1086990|NCT00599131|O1|Outcome|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.~On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.~Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
1086991|NCT00599131|O1|Outcome|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.~On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.~Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
1086992|NCT00599131|O1|Outcome|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.~On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.~Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
1086993|NCT00599131|O1|Outcome|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.~On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.~Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
1086994|NCT00599131|O1|Outcome|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.~On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.~Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
1086995|NCT00599131|E1|Reported Event|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.~On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.~Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
1086996|NCT00599053|B3|Baseline|Total|Total of all reporting groups
1086997|NCT00599053|B2|Baseline|Expectant (Usual) Management|Intervention at the discretion of the attending physician
1086998|NCT00599053|B1|Baseline|Early Treatment With Azithromycin|Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days
1088311|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1086999|NCT00599053|P2|Participant Flow|Expectant (Usual) Management|Intervention at the discretion of the attending physician
1087000|NCT00599053|P1|Participant Flow|Early Treatment With Azithromycin|Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days
1087001|NCT00599053|O2|Outcome|Expectant (Usual) Management|Intervention at the discretion of the attending physician
1087002|NCT00599053|O1|Outcome|Early Treatment With Azithromycin|Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days
1087003|NCT00599053|O2|Outcome|Expectant (Usual) Management|Intervention at the discretion of the attending physician
1087004|NCT00599053|O1|Outcome|Early Treatment With Azithromycin|Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days
1087005|NCT00599053|O2|Outcome|Expectant (Usual) Management|Intervention at the discretion of the attending physician
1087006|NCT00599053|O1|Outcome|Early Treatment With Azithromycin|Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days
1087007|NCT00599053|O2|Outcome|Expectant (Usual) Management|Intervention at the discretion of the attending physician
1087008|NCT00599053|O1|Outcome|Early Treatment With Azithromycin|Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days
1087009|NCT00599053|E2|Reported Event|Expectant (Usual) Management|Intervention at the discretion of the attending physician
1087010|NCT00599053|E1|Reported Event|Early Treatment With Azithromycin|Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days
1087011|NCT00599027|B3|Baseline|Total|Total of all reporting groups
1087012|NCT00599027|B2|Baseline|Placebo Nasal Spray|Placebo nasal spray once daily (two puffs per nostril) in the morning.
1087013|NCT00599027|B1|Baseline|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning.
1087014|NCT00599027|P2|Participant Flow|Placebo Nasal Spray|Placebo nasal spray once daily (two puffs per nostril) in the morning.
1087015|NCT00599027|P1|Participant Flow|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning.
1087016|NCT00599027|O2|Outcome|Placebo Nasal Spray|Placebo nasal spray once daily (two puffs per nostril) in the morning.
1087017|NCT00599027|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning.
1087018|NCT00599027|E2|Reported Event|Placebo Nasal Spray|Placebo nasal spray once daily (two puffs per nostril) in the morning.
1087019|NCT00599027|E1|Reported Event|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning.
1087020|NCT00599014|B1|Baseline|Patients With Heart Failure|All stable patients with heart failure willing to participate were enrolled to be followed-up for 5 years
1087021|NCT00599014|P1|Participant Flow|Patients With Heart Failure|All stable patients with heart failure willing to participate were enrolled to be followed-up for 5 years
1087022|NCT00599014|O1|Outcome|Patients With Heart Failure|All stable patients with heart failure willing to participate were enrolled to be followed-up for 5 years
1087023|NCT00599014|O1|Outcome|Patients With Heart Failure|All stable patients with heart failure willing to participate were enrolled to be followed-up for 5 years
1087024|NCT00599014|E1|Reported Event|Patients With Heart Failure|All stable patients with heart failure willing to participate were enrolled to be followed-up for 5 years
1087025|NCT00598871|B3|Baseline|Total|Total of all reporting groups
1087026|NCT00598871|B2|Baseline|Active Drug|Administration of 0.01% Tβ4 weight/weight (w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
1087027|NCT00598871|B1|Baseline|Placebo|Administration of 0.00% Thymosin beta 4 (Tβ4) weight/weight(w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
1087028|NCT00598871|P2|Participant Flow|Active Drug|Administration of 0.01% Tβ4 weight/weight (w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
1087029|NCT00598871|P1|Participant Flow|Placebo|Administration of 0.00% Thymosin beta 4 (Tβ4) weight/weight(w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
1087030|NCT00598871|O2|Outcome|Active Drug|Administration of 0.01% Tβ4 weight/weight (w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
1087031|NCT00598871|O1|Outcome|Placebo|Administration of 0.00% Thymosin beta 4 (Tβ4) weight/weight(w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
1087032|NCT00598871|O2|Outcome|Active Drug|Administration of 0.01% Tβ4 weight/weight (w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
1087033|NCT00598871|O1|Outcome|Placebo|Administration of 0.00% Thymosin beta 4 (Tβ4) weight/weight(w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
1087034|NCT00598871|E2|Reported Event|Active Drug|Administration of 0.01% Tβ4 weight/weight (w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
1087035|NCT00598871|E1|Reported Event|Placebo|Administration of 0.00% Thymosin beta 4 (Tβ4) weight/weight(w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
1087036|NCT00598832|B3|Baseline|Total|Total of all reporting groups
1087037|NCT00598832|B2|Baseline|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
1087038|NCT00598832|B1|Baseline|Adapalene Lotion 0.1%|once a day for 12 weeks
1087039|NCT00598832|P2|Participant Flow|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
1087040|NCT00598832|P1|Participant Flow|Adapalene Lotion 0.1%|once a day for 12 weeks
1087043|NCT00598832|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
1087044|NCT00598832|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
1087045|NCT00598832|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
1087046|NCT00598832|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
1087047|NCT00598832|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
1088328|NCT00594425|O3|Outcome|Vehicle PDT|
1087048|NCT00598832|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
1087049|NCT00598832|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
1087050|NCT00598832|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
1087051|NCT00598832|E2|Reported Event|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
1087052|NCT00598832|E1|Reported Event|Adapalene Lotion 0.1%|once a day for 12 weeks
1087053|NCT00598819|B1|Baseline|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
1087054|NCT00598819|P1|Participant Flow|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
1087055|NCT00598819|O1|Outcome|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
1087056|NCT00598819|O1|Outcome|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
1087057|NCT00598819|O1|Outcome|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
1087058|NCT00598819|O1|Outcome|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
1087059|NCT00598819|O1|Outcome|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
1087060|NCT00598819|E1|Reported Event|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
1087061|NCT00598702|B9|Baseline|Total|Total of all reporting groups
1087062|NCT00598702|B8|Baseline|Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h|Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
1087063|NCT00598702|B7|Baseline|Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h|Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
1087064|NCT00598702|B6|Baseline|Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h|Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
1087065|NCT00598702|B5|Baseline|Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h|Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
1087066|NCT00598702|B4|Baseline|Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h|Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
1087067|NCT00598702|B3|Baseline|Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h|Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
1087068|NCT00598702|B2|Baseline|Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h|Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
1087069|NCT00598702|B1|Baseline|Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h|Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
1087070|NCT00598702|P8|Participant Flow|Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h|Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
1087071|NCT00598702|P7|Participant Flow|Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h|Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
1087072|NCT00598702|P6|Participant Flow|Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h|Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
1087073|NCT00598702|P5|Participant Flow|Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h|Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
1087074|NCT00598702|P4|Participant Flow|Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h|Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
1087236|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
1088312|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1087075|NCT00598702|P3|Participant Flow|Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h|Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
1087076|NCT00598702|P2|Participant Flow|Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h|Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
1087077|NCT00598702|P1|Participant Flow|Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h|Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
1087078|NCT00598702|O8|Outcome|Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h|Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
1087079|NCT00598702|O7|Outcome|Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h|Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
1087080|NCT00598702|O6|Outcome|Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h|Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
1087081|NCT00598702|O5|Outcome|Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h|Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
1087082|NCT00598702|O4|Outcome|Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h|Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
1087083|NCT00598702|O3|Outcome|Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h|Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
1087084|NCT00598702|O2|Outcome|Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h|Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
1087085|NCT00598702|O1|Outcome|Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h|Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
1087086|NCT00598702|O8|Outcome|Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h|Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
1087087|NCT00598702|O7|Outcome|Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h|Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
1087088|NCT00598702|O6|Outcome|Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h|Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
1087089|NCT00598702|O5|Outcome|Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h|Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
1087090|NCT00598702|O4|Outcome|Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h|Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
1087091|NCT00598702|O3|Outcome|Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h|Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
1087092|NCT00598702|O2|Outcome|Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h|Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
1087093|NCT00598702|O1|Outcome|Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h|Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
1087094|NCT00598702|O8|Outcome|Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h|Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
1087095|NCT00598702|O7|Outcome|Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h|Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
1087096|NCT00598702|O6|Outcome|Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h|Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
1087097|NCT00598702|O5|Outcome|Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h|Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
1087098|NCT00598702|O4|Outcome|Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h|Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
1087099|NCT00598702|O3|Outcome|Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h|Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
1087100|NCT00598702|O2|Outcome|Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h|Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
1087101|NCT00598702|O1|Outcome|Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h|Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
1087102|NCT00598702|O8|Outcome|Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h|Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
1087103|NCT00598702|O7|Outcome|Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h|Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
1087104|NCT00598702|O6|Outcome|Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h|Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
1087105|NCT00598702|O5|Outcome|Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h|Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
1087106|NCT00598702|O4|Outcome|Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h|Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
1087237|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
1087238|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
1087107|NCT00598702|O3|Outcome|Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h|Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
1087108|NCT00598702|O2|Outcome|Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h|Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
1087109|NCT00598702|O1|Outcome|Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h|Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
1087110|NCT00598702|E8|Reported Event|Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h|Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
1087111|NCT00598702|E7|Reported Event|Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h|Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
1087112|NCT00598702|E6|Reported Event|Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h|Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
1087113|NCT00598702|E5|Reported Event|Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h|Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
1087114|NCT00598702|E4|Reported Event|Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h|Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
1087115|NCT00598702|E3|Reported Event|Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h|Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
1087116|NCT00598702|E2|Reported Event|Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h|Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
1087117|NCT00598702|E1|Reported Event|Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h|Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
1087118|NCT00598689|B3|Baseline|Total|Total of all reporting groups
1087119|NCT00598689|B2|Baseline|No Lubricant|Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
1087120|NCT00598689|B1|Baseline|Lubricant|"Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery.~0.3% hypromellose: 0.3% hypromellose four times a day for 5 days prior to LASIK surgery"
1087121|NCT00598689|P2|Participant Flow|No Lubricant|Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
1087122|NCT00598689|P1|Participant Flow|Lubricant|"Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery.~0.3% hypromellose: 0.3% hypromellose four times a day for 5 days prior to LASIK surgery"
1087123|NCT00598689|O2|Outcome|No Lubricant|Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
1087124|NCT00598689|O1|Outcome|Lubricant|"Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery.~0.3% hypromellose: 0.3% hypromellose four times a day for 5 days prior to LASIK surgery"
1087125|NCT00598689|O2|Outcome|No Lubricant|Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
1087126|NCT00598689|O1|Outcome|Lubricant|"Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery.~0.3% hypromellose: 0.3% hypromellose four times a day for 5 days prior to LASIK surgery"
1087127|NCT00598689|O2|Outcome|No Lubricant|Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
1087128|NCT00598689|O1|Outcome|Lubricant|"Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery.~0.3% hypromellose: 0.3% hypromellose four times a day for 5 days prior to LASIK surgery"
1087129|NCT00598689|E2|Reported Event|No Lubricant|Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
1087130|NCT00598689|E1|Reported Event|Lubricant|"Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery.~0.3% hypromellose: 0.3% hypromellose four times a day for 5 days prior to LASIK surgery"
1087131|NCT00598650|B1|Baseline|E2020|Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
1087132|NCT00598650|P1|Participant Flow|E2020|Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
1087133|NCT00598650|O2|Outcome|Placebo/E2020|Of the 104 patients of Arm 1, Arm 2 is patients from the placebo group in the preceding a 12-week, randomized, placebo-controlled trial (registered at ClinicalTrials.gov, number NCT00543855). That is to say Arm 1 consisted of 28 patients (Arm 2) from the placebo group in the preceding trial, and 76 patients from any of the E2020 group (3-mg group, 5-mg group, or 10-mg group).
1087134|NCT00598650|O1|Outcome|E2020|Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
1087135|NCT00598650|O2|Outcome|Placebo/E2020|Of the 104 patients of Arm 1, Arm 2 is patients from the placebo group in the preceding a 12-week, randomized, placebo-controlled trial (registered at ClinicalTrials.gov, number NCT00543855). That is to say Arm 1 consisted of 28 patients (Arm 2) from the placebo group in the preceding trial, and 76 patients from any of the E2020 group (3-mg group, 5-mg group, or 10-mg group).
1087136|NCT00598650|O1|Outcome|E2020|Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
1087239|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
1087137|NCT00598650|E1|Reported Event|E2020|Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
1087138|NCT00598559|B4|Baseline|Total|Total of all reporting groups
1087240|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
1087139|NCT00598559|B3|Baseline|Standard of Care (SOC)|All Subjects Randomized to Receive standard of care treatment under the discretion of the Investigator and the medical staff caring for them.
1087140|NCT00598559|B2|Baseline|IV Acetaminophen 650 mg q4h|All Subjects Randomized to Receive 650 mg IV acetaminophen administered every 4 hours.
1087141|NCT00598559|B1|Baseline|IV Acetaminophen 1g q6h|All Subjects Randomized to Receive IV acetaminophen 1g administered every 6 hours.
1087142|NCT00598559|P3|Participant Flow|Standard of Care (SOC)|All Subjects Randomized to Receive standard of care treatment under the discretion of the Investigator and the medical staff caring for them.
1087143|NCT00598559|P2|Participant Flow|IV Acetaminophen 650 Milligram Every 4 Hours|All Subjects Randomized to Receive 650 mg IV acetaminophen administered every 4 hours.
1087144|NCT00598559|P1|Participant Flow|IV Acetaminophen 1 Gram Every 6 Hours|All Subjects Randomized to Receive IV acetaminophen 1 gram administered every 6 hours.
1087145|NCT00598559|O3|Outcome|Standard of Care (SOC)|mITT Population, Subjects Who Received Standard of Care Treatment.
1087146|NCT00598559|O2|Outcome|IV Acetaminophen 650 mg q4h|mITT Population, IV acetaminophen 650 mg administered every 4 hours.
1087147|NCT00598559|O1|Outcome|IV Acetaminophen 1 g q6h|mITT Population, IV acetaminophen 1 g administered every 6 hours.
1087148|NCT00598559|O3|Outcome|Standard of Care (SOC)|mITT Population, Subjects Who Received Standard of Care Treatment.
1087149|NCT00598559|O2|Outcome|IV Acetaminophen 650 mg q4h|mITT Population, IV acetaminophen 650 mg administered every 4 hours.
1087150|NCT00598559|O1|Outcome|IV Acetaminophen 1 g q6h|mITT Population, IV acetaminophen 1 g administered every 6 hours.
1087151|NCT00598559|O3|Outcome|Standard of Care (SOC)|mITT Population, Subjects Who Received Standard of Care Treatment.
1087152|NCT00598559|O2|Outcome|IV Acetaminophen 650 mg q4h|mITT Population, IV acetaminophen 650 mg administered every 4 hours.
1087153|NCT00598559|O1|Outcome|IV Acetaminophen 1 g q6h|mITT Population, IV acetaminophen 1 g administered every 6 hours.
1087154|NCT00598559|O3|Outcome|Standard of Care (SOC)|mITT Population, Subjects Who Received Standard of Care Treatment.
1087155|NCT00598559|O2|Outcome|IV Acetaminophen 650 mg q4h|mITT Population, IV acetaminophen 650 mg administered every 4 hours.
1087156|NCT00598559|O1|Outcome|IV Acetaminophen 1 g q6h|mITT Population, IV acetaminophen 1 g administered every 6 hours.
1087157|NCT00598559|E3|Reported Event|Standard of Care (SOC)|All Subjects Randomized to Receive standard of care treatment under the discretion of the Investigator and the medical staff caring for them.
1087158|NCT00598559|E2|Reported Event|IV Acetaminophen 650 Milligram Every 4 Hours|All Subjects Randomized to Receive 650 mg IV acetaminophen administered every 4 hours.
1087159|NCT00598559|E1|Reported Event|IV Acetaminophen 1 Gram Every 6 Hours|All Subjects Randomized to Receive IV acetaminophen 1 gram administered every 6 hours.
1087160|NCT00598507|B1|Baseline|Chemotherapy - ZK-EPO|ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
1087161|NCT00598507|P1|Participant Flow|Chemotherapy - ZK-EPO|ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
1087162|NCT00598507|O1|Outcome|Chemotherapy - ZK-EPO|ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
1087163|NCT00598507|O1|Outcome|Chemotherapy - ZK-EPO|ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
1087164|NCT00598507|O1|Outcome|Chemotherapy - ZK-EPO|ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
1087165|NCT00598507|O1|Outcome|Chemotherapy - ZK-EPO|ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
1087166|NCT00598507|E1|Reported Event|Chemotherapy - ZK-EPO|ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
1087167|NCT00598442|B4|Baseline|Total|Total of all reporting groups
1087168|NCT00598442|B3|Baseline|Darbepoetin Alfa|Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1087169|NCT00598442|B2|Baseline|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1087170|NCT00598442|B1|Baseline|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
1087171|NCT00598442|P3|Participant Flow|Darbepoetin Alfa|Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1087172|NCT00598442|P2|Participant Flow|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1087173|NCT00598442|P1|Participant Flow|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
1087174|NCT00598442|O3|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1088313|NCT00594425|O3|Outcome|Vehicle PDT|
1087175|NCT00598442|O2|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1088329|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1087176|NCT00598442|O1|Outcome|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
1087177|NCT00598442|O3|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1087178|NCT00598442|O2|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1087179|NCT00598442|O1|Outcome|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
1087180|NCT00598442|O3|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1087181|NCT00598442|O2|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1087182|NCT00598442|O1|Outcome|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
1087183|NCT00598442|E3|Reported Event|Darbepoetin Alfa|Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1087184|NCT00598442|E2|Reported Event|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1087185|NCT00598442|E1|Reported Event|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
1087186|NCT00598273|B4|Baseline|Total|Total of all reporting groups
1087187|NCT00598273|B3|Baseline|Darbepoetin Alfa|Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1087188|NCT00598273|B2|Baseline|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1087189|NCT00598273|B1|Baseline|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
1087190|NCT00598273|P3|Participant Flow|Darbepoetin Alfa|Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1087191|NCT00598273|P2|Participant Flow|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1087192|NCT00598273|P1|Participant Flow|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
1087193|NCT00598273|O3|Outcome|Darbepoetin Alfa|Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1087194|NCT00598273|O2|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1087195|NCT00598273|O1|Outcome|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
1087196|NCT00598273|O3|Outcome|Darbepoetin Alfa|Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1087197|NCT00598273|O2|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1087198|NCT00598273|O1|Outcome|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
1087199|NCT00598273|O3|Outcome|Darbepoetin Alfa|Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1087200|NCT00598273|O2|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1087241|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
1087242|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
1087201|NCT00598273|O1|Outcome|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
1087202|NCT00598273|E3|Reported Event|Darbepoetin Alfa|Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1087203|NCT00598273|E2|Reported Event|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
1087204|NCT00598273|E1|Reported Event|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
1087205|NCT00598078|B1|Baseline|All Study Participants|All treated study participants
1087206|NCT00598078|P2|Participant Flow|Regimen A, Then C, Then B|Day 1: Sodium Oxybate 0.75g at ~8am, Sodium Oxybate 0.75g at ~10am, placebo at ~12pm; Day 2: Placebo at ~8am, ~10am, and ~12pm; Day 3: Sodium Oxybate 1.5g at ~8am, placebo at ~10am, Sodium Oxybate 1.5g at ~12pm;
1087207|NCT00598078|P1|Participant Flow|Regimen A, Then B, Then C|Day 1: Sodium Oxybate 0.75g at ~8am, Sodium Oxybate 0.75g at ~10am, placebo at ~12pm; Day 2:Sodium Oxybate 1.5g at ~8am, placebo at ~10am, Sodium Oxybate 1.5g at ~12pm; Day 3:Placebo at ~8am, ~10am, and ~12pm
1087208|NCT00598078|O3|Outcome|Placebo (C)|Placebo at ~8am, ~10am, and ~12pm (Day 2 or 3)
1087209|NCT00598078|O2|Outcome|Sodium Oxybate 3 Grams (B)|Sodium Oxybate 1.5g at ~8am, placebo at ~10am, Sodium Oxybate 1.5g at ~12pm (Day 2 or 3)
1087210|NCT00598078|O1|Outcome|Sodium Oxybate 1.5 Grams (A)|Sodium Oxybate 0.75g at ~8am, Sodium Oxybate 0.75g at ~10am, placebo at ~12pm (Day 1 only)
1087211|NCT00598078|E3|Reported Event|Placebo (C)|Placebo at ~8am, ~10am, and ~12pm (Day 2 or 3)
1087212|NCT00598078|E2|Reported Event|Sodium Oxybate 3 Grams (B)|Sodium Oxybate 1.5g at ~8am, placebo at ~10am, Sodium Oxybate 1.5g at ~12pm (Day 2 or 3)
1087213|NCT00598078|E1|Reported Event|Sodium Oxybate 1.5 Grams (A)|Sodium Oxybate 0.75g at ~8am, Sodium Oxybate 0.75g at ~10am, placebo at ~12pm (Day 1 only)
1087214|NCT00597909|B4|Baseline|Total|Total of all reporting groups
1087215|NCT00597909|B3|Baseline|Arm 3|placebo solution (10% dextrose): Placebo solution (10% dextrose), IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
1087216|NCT00597909|B2|Baseline|Arm 2|sodium phenylacetate and sodium benzoate injection 10% / 10%: 2.75 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
1087217|NCT00597909|B1|Baseline|Arm 1|sodium phenylacetate and sodium benzoate injection 10% / 10%: 5.5 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
1087218|NCT00597909|P3|Participant Flow|Arm 3|placebo solution (10% dextrose): Placebo solution (10% dextrose), IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
1087219|NCT00597909|P2|Participant Flow|Arm 2|sodium phenylacetate and sodium benzoate injection 10% / 10%: 2.75 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
1087220|NCT00597909|P1|Participant Flow|Arm 1|sodium phenylacetate and sodium benzoate injection 10% / 10%: 5.5 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
1087221|NCT00597909|O3|Outcome|Arm 3|placebo solution (10% dextrose): Placebo solution (10% dextrose), IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
1087222|NCT00597909|O2|Outcome|Arm 2|sodium phenylacetate and sodium benzoate injection 10% / 10%: 2.75 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
1087223|NCT00597909|O1|Outcome|Arm 1|sodium phenylacetate and sodium benzoate injection 10% / 10%: 5.5 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
1087224|NCT00597909|E3|Reported Event|Arm 3|placebo solution (10% dextrose): Placebo solution (10% dextrose), IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
1087225|NCT00597909|E2|Reported Event|Arm 2|sodium phenylacetate and sodium benzoate injection 10% / 10%: 2.75 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
1087226|NCT00597909|E1|Reported Event|Arm 1|sodium phenylacetate and sodium benzoate injection 10% / 10%: 5.5 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
1087227|NCT00597896|B3|Baseline|Total|Total of all reporting groups
1087228|NCT00597896|B2|Baseline|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
1087229|NCT00597896|B1|Baseline|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
1087230|NCT00597896|P2|Participant Flow|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
1087231|NCT00597896|P1|Participant Flow|Active Pramipexole|0.125 mg BID-0.75 mg BID pramipexole
1087232|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
1087233|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
1087234|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
1087235|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
1172350|NCT00381303|O3|Outcome|Black|
1087243|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
1087244|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
1087245|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
1087246|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
1087247|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
1087248|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
1087249|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
1087250|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
1087251|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
1087252|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
1087253|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID pramipexole
1087254|NCT00597896|E2|Reported Event|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
1087255|NCT00597896|E1|Reported Event|Active Pramipexole|0.125 mg BID-0.75 mg BID pramipexole
1087256|NCT00597753|B3|Baseline|Total|Total of all reporting groups
1087257|NCT00597753|B2|Baseline|Epoetin Alfa|Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
1087258|NCT00597753|B1|Baseline|Peginesatide|Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
1087259|NCT00597753|P2|Participant Flow|Epoetin Alfa|Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
1087260|NCT00597753|P1|Participant Flow|Peginesatide|Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
1087261|NCT00597753|O2|Outcome|Epoetin Alfa|Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
1087262|NCT00597753|O1|Outcome|Peginesatide|Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
1087263|NCT00597753|O2|Outcome|Epoetin Alfa|Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
1087264|NCT00597753|O1|Outcome|Peginesatide|Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
1087265|NCT00597753|O2|Outcome|Epoetin Alfa|Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
1087266|NCT00597753|O1|Outcome|Peginesatide|Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
1088314|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1087433|NCT00597272|P3|Participant Flow|Cohort 1C|Cohort 1C: 100mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
1087434|NCT00597272|P2|Participant Flow|Cohort 1B|Cohort 1B: 75mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
1087435|NCT00597272|P1|Participant Flow|Cohort 1A|Cohort 1A: 50mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
1087267|NCT00597753|E2|Reported Event|Epoetin Alfa|Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
1087268|NCT00597753|E1|Reported Event|Peginesatide|Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
1087269|NCT00597727|B5|Baseline|Total|Total of all reporting groups
1087270|NCT00597727|B4|Baseline|Pilot Peanut SLIT Rollover Cohort|Subjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort.
1087271|NCT00597727|B3|Baseline|Early Unblinded Peanut SLIT|Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort.
1087272|NCT00597727|B2|Baseline|Blinded Placebo SLIT|"Blinded subjects who receive placebo (glycerin sublingual drops) at the beginning of the study.~Placebo SLIT: Liquid glycerin without peanut which are dosed under the tongue."
1087273|NCT00597727|B1|Baseline|Blinded Peanut SLIT|Blinded subjects who received peanut sublingual drops) at the beginning of the study.
1087274|NCT00597727|P5|Participant Flow|Pilot Peanut SLIT Rollover Cohort|Subjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort.
1087275|NCT00597727|P4|Participant Flow|Early Unblinded Peanut SLIT|Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort.
1087276|NCT00597727|P3|Participant Flow|Ext Maint Open Label Peanut SLIT|After completing the blinded phase of the study, subjects receiving Blinded Peanut SLIT continued on extended maintenance open-label peanut SLIT for the duration of the study. Subjects receiving Blinded Placebo SLIT were crossed over and underwent the 12 month buildup protocol on open label peanut SLIT and then continued on extended maintenance treatment for the duration of the study.
1087277|NCT00597727|P2|Participant Flow|Blinded Placebo SLIT|Blinded subjects who received placebo sublingual drops for the initial 12 month blinded phase of the study.
1087278|NCT00597727|P1|Participant Flow|Blinded Peanut SLIT|Blinded subjects who received peanut sublingual drops for the initial 12 month blinded phase of the study.
1087279|NCT00597727|O3|Outcome|Pilot Peanut SLIT Rollover Cohort|Subjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort.
1087280|NCT00597727|O2|Outcome|Early Unblinded Peanut SLIT|Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort.
1087281|NCT00597727|O1|Outcome|Ext Maint Open Label Peanut SLIT|After completing the blinded phase of the study, subjects receiving Blinded Peanut SLIT continued on extended maintenance open-label peanut SLIT for the duration of the study. Subjects receiving Blinded Placebo SLIT were crossed over and underwent the 12 month buildup protocol on open label peanut SLIT and then continued on extended maintenance treatment for the duration of the study.
1087282|NCT00597727|O4|Outcome|Pilot Peanut SLIT Rollover Cohort|Subjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort.
1087283|NCT00597727|O3|Outcome|Early Unblinded Peanut SLIT|Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort.
1087284|NCT00597727|O2|Outcome|Blinded Placebo SLIT|Blinded subjects who received placebo sublingual drops for the initial 12 month blinded phase of the study.
1087285|NCT00597727|O1|Outcome|Blinded Peanut SLIT|Blinded subjects who received peanut sublingual drops for the initial 12 month blinded phase of the study.
1087286|NCT00597727|E5|Reported Event|Pilot Peanut SLIT Rollover Cohort|Subjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort.
1087287|NCT00597727|E4|Reported Event|Early Unblinded Peanut SLIT|Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort.
1087288|NCT00597727|E3|Reported Event|Ext Maint Open Label Peanut SLIT|After completing the blinded phase of the study, subjects receiving Blinded Peanut SLIT continued on extended maintenance open-label peanut SLIT for the duration of the study. Subjects receiving Blinded Placebo SLIT were crossed over and underwent the 12 month buildup protocol on open label peanut SLIT and then continued on extended maintenance treatment for the duration of the study.
1087289|NCT00597727|E2|Reported Event|Blinded Placebo SLIT|Blinded subjects who received placebo sublingual drops for the initial 12 month blinded phase of the study.
1087290|NCT00597727|E1|Reported Event|Blinded Peanut SLIT|Blinded subjects who received peanut sublingual drops for the initial 12 month blinded phase of the study.
1087291|NCT00597714|B3|Baseline|Total|Total of all reporting groups
1087292|NCT00597714|B2|Baseline|Cohort B - Myeloid Disease|Non-myeloablative stem cell transplant (SCT): Donor will receive granulocyte colony stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The PBSCs will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
1087361|NCT00597506|P1|Participant Flow|Drug: Bevacizumab and Everolimus|Open-label, non-randomized expanded cohort trial of refractory metastatic colorectal cancer subjects treated on 28 day cycles with the following treatment regimen: 10 mg/kg intravenous bevacizumab on days 1 and 15 each cycle and 10 mg everolimus(RAD001) daily by mouth.
1087293|NCT00597714|B1|Baseline|Cohort A - Lymphoid Disease|Non-myeloablative stem cell transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The PBSCs will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
1087294|NCT00597714|P3|Participant Flow|Donor|"5-6/6 matched sibling who meets the other donor criteria is the first choice,~Matched Unrelated Donor (MUD) is the second choice*, and~3-5/6 partially matched family member (if 5/6 then this donor is not a sibling as that would be first choice) is the third choice for donor type.~Multiple choices for 3-5/6 human leukocyte antigen (HLA) matched family member donors order of choice will be best match, then cytomegalovirus (CMV) negativity, then Killer-cell immunoglobulin-like receptors (KIR) mismatching (for natural killer [NK] cell activity), then history of pregnancy. All subjects without an available matched sibling must have a donor search initiated with the national bank. If potential high resolution matches are found but not utilized, the reason for proceeding with a partially matched family member should be documented (i.e. donor not available, not enough time to allow MUD donor work up and collection due to high risk nature of the subject's disease, etc)."
1087295|NCT00597714|P2|Participant Flow|Cohort B - Myeloid Disease|Non-myeloablative stem cell transplant (SCT): Donor will receive granulocyte colony stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The PBSCs will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
1087296|NCT00597714|P1|Participant Flow|Cohort A - Lymphoid Disease|Non-myeloablative stem cell transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The PBSCs will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
1087297|NCT00597714|O1|Outcome|Cohort A & B - Lymphoid & Myeloid Disease|Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen for myeloid disease will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours.The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
1087298|NCT00597714|O1|Outcome|Cohort A & B - Lymphoid & Myeloid Disease|Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen for myeloid disease will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours.The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
1087299|NCT00597714|O1|Outcome|Cohort A & B - Lymphoid & Myeloid Disease|Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen for myeloid disease will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
1087300|NCT00597714|O1|Outcome|Cohort A & B - Lymphoid & Myeloid Disease|Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. For the myeloid group, the prep regimen will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
1087362|NCT00597506|O1|Outcome|Bevacizumab and Everolimus|Enrolled participants on research study received bevacizumab at 10mg/kg every 2 weeks (day 1 and day 15 of each 28 day cycle) and everolimus at 10mg orally daily
1172351|NCT00381303|O2|Outcome|Male|
1087301|NCT00597714|O1|Outcome|Cohort A & B- Lymphoid & Myeloid Disease|Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
1087302|NCT00597714|O1|Outcome|Cohort A & B- Lymphoid & Myeloid Disease|Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen for myeloid disease will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
1087303|NCT00597714|E2|Reported Event|Cohort B - Myeloid Disease|Non-myeloablative stem cell transplant (SCT): Donor will receive granulocyte colony stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The peripheral blood stem cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
1087304|NCT00597714|E1|Reported Event|Cohort A - Lymphoid Disease|Non-myeloablative stem cell transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The peripheral blood stem cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
1087305|NCT00597701|B3|Baseline|Total|Total of all reporting groups
1087306|NCT00597701|B2|Baseline|Placebo|Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours.
1087307|NCT00597701|B1|Baseline|Baclofen|Standard benzodiazepine therapy plus baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
1087308|NCT00597701|P2|Participant Flow|Placebo|Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours.
1087309|NCT00597701|P1|Participant Flow|Baclofen|Standard benzodiazepine therapy plus baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
1087310|NCT00597701|O2|Outcome|Placebo|Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours.
1087311|NCT00597701|O1|Outcome|Baclofen|Standard benzodiazepine therapy plus baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
1087312|NCT00597701|E2|Reported Event|Placebo|Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours.
1087313|NCT00597701|E1|Reported Event|Baclofen|Standard benzodiazepine therapy plus baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
1087314|NCT00597675|B3|Baseline|Total|Total of all reporting groups
1087315|NCT00597675|B2|Baseline|Peanut OIT|Peanut flour ingested daily as active OIT treatment
1087316|NCT00597675|B1|Baseline|Placebo|Oat flour taken daily as a placebo
1087317|NCT00597675|P2|Participant Flow|Peanut OIT|Peanut flour ingested daily as active OIT treatment
1087318|NCT00597675|P1|Participant Flow|Placebo|Oat flour taken daily as a placebo
1087319|NCT00597675|O1|Outcome|Open Label Peanut OIT|All subjects on active treatment after placebo subjects have been crossed over to open label treatment
1087320|NCT00597675|O1|Outcome|Open Label Peanut OIT|All subjects on active treatment after placebo subjects have been crossed over to open label treatment
1087321|NCT00597675|O1|Outcome|Open Label Peanut OIT|All subjects on active treatment after placebo subjects have been crossed over to open label treatment
1087322|NCT00597675|O2|Outcome|Peanut OIT|Peanut flour ingested daily as active OIT treatment
1087323|NCT00597675|O1|Outcome|Placebo|Oat flour taken daily as a placebo
1087324|NCT00597675|O1|Outcome|Open Label Peanut OIT|All subjects on active treatment after placebo subjects have been crossed over to open label treatment
1087325|NCT00597675|E3|Reported Event|Blinded Phase-Peanut OIT|Patients receiving peanut flour as active OIT during the initial 12 months of therapy.
1087326|NCT00597675|E2|Reported Event|Blinded Phase-Placebo|Patients receiving oat flour as a placebo during the initial 12 months of therapy.
1087327|NCT00597675|E1|Reported Event|Open Label Phase-Peanut OIT|All subjects receiving open-label peanut OIT from the point of unblinding through the end of the treatment phase.
1087328|NCT00597584|B3|Baseline|Total|Total of all reporting groups
1087363|NCT00597506|O1|Outcome|Bevacizumab and Everolimus|Enrolled participants on research study received bevacizumab at 10mg/kg every 2 weeks (day 1 and day 15 of each 28 day cycle) and everolimus at 10mg orally daily
1087432|NCT00597272|P4|Participant Flow|Cohort 2A|Cohort 2A: 50mcg QS-DG weeks 1, 2, 3, 8, 20, 32
1087329|NCT00597584|B2|Baseline|Epoetin|"Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta administered after randomization at Week 0.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
1087330|NCT00597584|B1|Baseline|Peginesatide|"Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
1087331|NCT00597584|P2|Participant Flow|Epoetin|"Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta administered after randomization at Week 0.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
1087332|NCT00597584|P1|Participant Flow|Peginesatide|"Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
1087333|NCT00597584|O2|Outcome|Epoetin|"Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta administered after randomization at Week 0.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
1087334|NCT00597584|O1|Outcome|Peginesatide|"Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
1087335|NCT00597584|O2|Outcome|Epoetin|"Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta administered after randomization at Week 0.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
1087336|NCT00597584|O1|Outcome|Peginesatide|"Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
1087337|NCT00597584|O2|Outcome|Epoetin|"Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta administered after randomization at Week 0.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
1087338|NCT00597584|O1|Outcome|Peginesatide|"Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
1087364|NCT00597506|E1|Reported Event|Bevacizumab and Everolimus|Expanded Cohort of Patients with Refractory Metastatic Colorectal Cancer Treated With Bevacizumab and Everolimus
1087429|NCT00597272|P7|Participant Flow|Cohort 3|Cohort 3: 150mcg OPT-821 for first 5 vaccines with a 50 mcg increase in dose for the final vaccine.
1087430|NCT00597272|P6|Participant Flow|Cohort 2C|Cohort 2C: 100mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
1087339|NCT00597584|E2|Reported Event|Epoetin|"Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta administered after randomization at Week 0.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
1087340|NCT00597584|E1|Reported Event|Peginesatide|"Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
1087341|NCT00597558|B1|Baseline|Egg White Protein Powder|Egg allergic subjects who ingest oral egg white protein for desensitization and possible tolerance.
1087342|NCT00597558|P1|Participant Flow|Egg White Protein Powder|Egg allergic subjects who ingest oral egg white protein for desensitization and possible tolerance.
1087343|NCT00597558|O1|Outcome|Egg White Protein Powder|Egg allergic subjects who ingest oral egg white protein
1087344|NCT00597558|O1|Outcome|Egg White Protein Powder|Egg allergic subjects who ingest oral egg white protein
1087345|NCT00597558|O1|Outcome|Egg White Protein Powder|Egg allergic subjects who ingest oral egg white protein
1087346|NCT00597558|E1|Reported Event|Egg White Protein Powder|Egg allergic subjects who ingest oral egg white protein
1087347|NCT00597545|B3|Baseline|Total|Total of all reporting groups
1087348|NCT00597545|B2|Baseline|Prophylactic Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt even when by standard criteria they would not need to receive one.~Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain~Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
1087349|NCT00597545|B1|Baseline|Conventional Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt only if it is indicated by EEG, by conventional management.~Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain~Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
1087350|NCT00597545|P2|Participant Flow|Prophylactic Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt even when by standard criteria they would not need to receive one.~Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain~Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
1087351|NCT00597545|P1|Participant Flow|Conventional Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt only if it is indicated by EEG, by conventional management.~Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain~Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
1087352|NCT00597545|O2|Outcome|Prophylactic Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt even when by standard criteria they would not need to receive one.~Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain~Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
1087353|NCT00597545|O1|Outcome|Conventional Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt only if it is indicated by EEG, by conventional management.~Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain~Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
1087354|NCT00597545|E2|Reported Event|Prophylactic Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt even when by standard criteria they would not need to receive one.~Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain~Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
1087355|NCT00597545|E1|Reported Event|Conventional Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt only if it is indicated by EEG, by conventional management.~Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain~Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
1087356|NCT00597519|B1|Baseline|Treatment|Cyclophosphamide, Fludarabine and Total Body Irradiation Followed by the Transplantation of Unrelated Donor Double Unit Umbilical Cord Blood Grafts for Patients with Hematological Malignancy
1087357|NCT00597519|P1|Participant Flow|Treatment|Cyclophosphamide, Fludarabine and Total Body Irradiation Followed by the Transplantation of Unrelated Donor Double Unit Umbilical Cord Blood Grafts for Patients with Hematological Malignancy
1087358|NCT00597519|O1|Outcome|Treatment|Cyclophosphamide, Fludarabine and Total Body Irradiation Followed by the Transplantation of Unrelated Donor Double Unit Umbilical Cord Blood Grafts for Patients with Hematological Malignancy
1087359|NCT00597519|E1|Reported Event|Treatment|Cyclophosphamide, Fludarabine and Total Body Irradiation Followed by the Transplantation of Unrelated Donor Double Unit Umbilical Cord Blood Grafts for Patients with Hematological Malignancy
1087360|NCT00597506|B1|Baseline|Bevacizumab and Everolimus|Expanded Cohort of Patients with Refractory Metastatic Colorectal Cancer Treated With Bevacizumab and Everolimus
1088315|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1087365|NCT00597493|B1|Baseline|Sorafenib + Temozolomide|"Subjects receive 400mg of Sorafenib twice daily and 50mg/m^2 of Temozolomide once daily~Subjects continue to receive treatment until any of the following: progressive disease, unacceptable toxicity, non-compliance with study guidelines, withdrawal of patient consent, intercurrent non-cancer-related illness that prevents continuation of therapy or regular follow-up, general or specific changs in a subject's condition which render the patient unacceptable for treatment in the judgement of the investigator, or study closure"
1087366|NCT00597493|P1|Participant Flow|Sorafenib + Temozolomide|"Subjects receive 400mg of Sorafenib twice daily and 50mg/m^2 of Temozolomide once daily~Subjects continue to receive treatment until any of the following: progressive disease, unacceptable toxicity, non-compliance with study guidelines, withdrawal of patient consent, intercurrent non-cancer-related illness that prevents continuation of therapy or regular follow-up, general or specific changs in a subject's condition which render the patient unacceptable for treatment in the judgement of the investigator, or study closure"
1087367|NCT00597493|O4|Outcome|Non-EIAEDs-Day 28|Blood samples taken on day 28 of cycle 1 from patients not currently taking EIAEDs.
1087368|NCT00597493|O3|Outcome|Non-EIAEDs-Day 1|Blood samples taken on day 1 of cycle 1 from patients not currently taking EIAEDs.
1087369|NCT00597493|O2|Outcome|EIAEDs-Day 28|Blood samples taken on day 28 of cycle 1 from patients currently taking EIAEDs.
1087370|NCT00597493|O1|Outcome|EIAEDs-Day 1|Blood samples taken on day 1 of cycle 1 from patients currently taking EIAEDs.
1087371|NCT00597493|O4|Outcome|Non-EIAEDs-Day 28|Blood samples taken on day 28 of cycle 1 from patients not currently taking EIAEDs.
1087372|NCT00597493|O3|Outcome|Non-EIAEDs-Day 1|Blood samples taken on day 1 of cycle 1 from patients not currently taking EIAEDs.
1087373|NCT00597493|O2|Outcome|EIAEDs-Day 28|Blood samples taken on day 28 of cycle 1 from patients currently taking EIAEDs.
1087374|NCT00597493|O1|Outcome|EIAEDs-Day 1|Blood samples taken on day 1 of cycle 1 from patients currently taking EIAEDs.
1087375|NCT00597493|O4|Outcome|Non-EIAEDs-Day 28|Blood samples taken on day 28 of cycle 1 from patients not currently taking EIAEDs.
1087376|NCT00597493|O3|Outcome|Non-EIAEDs-Day 1|Blood samples taken on day 1 of cycle 1 from patients not currently taking EIAEDs.
1087377|NCT00597493|O2|Outcome|EIAEDs-Day 28|Blood samples taken on day 28 of cycle 1 from patients currently taking EIAEDs.
1087378|NCT00597493|O1|Outcome|EIAEDs-Day 1|Blood samples taken on day 1 of cycle 1 from patients currently taking EIAEDs.
1087379|NCT00597493|O1|Outcome|Sorafenib + Temozolomide|"Subjects receive 400mg of Sorafenib twice daily and 50mg/m^2 of Temozolomide once daily~Subjects continue to receive treatment until any of the following: progressive disease, unacceptable toxicity, non-compliance with study guidelines, withdrawal of patient consent, intercurrent non-cancer-related illness that prevents continuation of therapy or regular follow-up, general or specific changs in a subject's condition which render the patient unacceptable for treatment in the judgement of the investigator, or study closure"
1087380|NCT00597493|O1|Outcome|Sorafenib + Temozolomide|"Subjects receive 400mg of Sorafenib twice daily and 50mg/m^2 of Temozolomide once daily~Subjects continue to receive treatment until any of the following: progressive disease, unacceptable toxicity, non-compliance with study guidelines, withdrawal of patient consent, intercurrent non-cancer-related illness that prevents continuation of therapy or regular follow-up, general or specific changs in a subject's condition which render the patient unacceptable for treatment in the judgement of the investigator, or study closure"
1087381|NCT00597493|E1|Reported Event|Sorafenib + Temozolomide|"Subjects receive 400mg of Sorafenib twice daily and 50mg/m^2 of Temozolomide once daily~Subjects continue to receive treatment until any of the following: progressive disease, unacceptable toxicity, non-compliance with study guidelines, withdrawal of patient consent, intercurrent non-cancer-related illness that prevents continuation of therapy or regular follow-up, general or specific changs in a subject's condition which render the patient unacceptable for treatment in the judgement of the investigator, or study closure"
1087382|NCT00597428|B3|Baseline|Total|Total of all reporting groups
1087383|NCT00597428|B2|Baseline|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
1087384|NCT00597428|B1|Baseline|Placebo|Placebo : 0 mcg capsules twice daily (BID)
1087385|NCT00597428|P2|Participant Flow|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID) for 12 weeks
1087386|NCT00597428|P1|Participant Flow|Placebo|Placebo : 0 mcg capsules twice daily (BID) for 12 weeks
1087387|NCT00597428|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
1087388|NCT00597428|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
1087389|NCT00597428|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
1087390|NCT00597428|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
1087391|NCT00597428|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
1087392|NCT00597428|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
1087393|NCT00597428|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
1087394|NCT00597428|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
1087395|NCT00597428|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
1087396|NCT00597428|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
1087397|NCT00597428|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
1087398|NCT00597428|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
1087399|NCT00597428|E2|Reported Event|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
1087400|NCT00597428|E1|Reported Event|Placebo|Placebo : 0 mcg capsules twice daily (BID)
1087401|NCT00597402|B1|Baseline|Avastin, Radiation, Temozolomide, and Irinotecan|"Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.~Following completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)"
1087431|NCT00597272|P5|Participant Flow|Cohort 2B|Cohort 2B: 75mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
1087402|NCT00597402|P1|Participant Flow|Avastin, Radiation, Temozolomide, and Irinotecan|"Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.~Following completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)"
1087403|NCT00597402|O1|Outcome|Avastin, Radiation, Temozolomide, and Irinotecan|"Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.~Following completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)"
1087404|NCT00597402|O1|Outcome|Avastin, Radiation, Temozolomide, and Irinotecan|"Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.~Following completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)"
1087405|NCT00597402|O1|Outcome|Avastin, Radiation, Temozolomide, and Irinotecan|"Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.~Following completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)"
1087406|NCT00597402|O1|Outcome|Avastin, Radiation, Temozolomide, and Irinotecan|"Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.~Following completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)"
1087407|NCT00597402|E1|Reported Event|Avastin, Radiation, Temozolomide, and Irinotecan|"Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.~Following completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)"
1087408|NCT00597376|B3|Baseline|Total|Total of all reporting groups
1087409|NCT00597376|B2|Baseline|Cerefolin NAC Placebo + Multivitamin|"On placebo and open label multivitamin supplement~Cerefolin NAC placebo : Placebo tablet once a day"
1087410|NCT00597376|B1|Baseline|Cerefolin NAC + Multivitamin|"On Cerefolin NAC and open-label multivitamin supplement~Cerefolin NAC (a medical food) : Cerefolin NAC one tablet each day"
1087411|NCT00597376|P2|Participant Flow|Cerefolin NAC Placebo + Multivitamin|"On placebo and open label multivitamin supplement~Cerefolin NAC placebo : Placebo tablet once a day"
1087412|NCT00597376|P1|Participant Flow|Cerefolin NAC + Multivitamin|"On Cerefolin NAC and open-label multivitamin supplement~Cerefolin NAC (a medical food) : Cerefolin NAC one tablet each day"
1087413|NCT00597376|O2|Outcome|Cerefolin NAC Placebo + Multivitamin|On placebo and open-label multivitamin supplement
1087414|NCT00597376|O1|Outcome|Cerefolin NAC + Multivitamin|On Cerefolin NAC and open-label multivitamin supplement
1087415|NCT00597376|O2|Outcome|Cerefolin NAC Placebo + Multivitamin|On placebo and open-label multivitamin supplement
1087416|NCT00597376|O1|Outcome|Cerefolin NAC + Multivitamin|On Cerefolin NAC and open-label multivitamin supplement
1087417|NCT00597376|O2|Outcome|Cerefolin NAC Placebo + Multivitamin|On placebo and open-label multivitamin supplement
1087418|NCT00597376|O1|Outcome|Cerefolin NAC + Multivitamin|On Cerefolin NAC and open-label multivitamin supplement
1087419|NCT00597376|E2|Reported Event|Cerefolin NAC Placebo + Multivitamin|On placebo and open-label multivitamin supplement
1087420|NCT00597376|E1|Reported Event|Cerefolin NAC + Multivitamin|On Cerefolin NAC and open-label multivitamin supplement
1087421|NCT00597272|B8|Baseline|Total|Total of all reporting groups
1087422|NCT00597272|B7|Baseline|Cohort 3|Cohort 3: 150mcg OPT-821 for first 5 vaccines with a 50 mcg increase in dose for the final vaccine.
1087423|NCT00597272|B6|Baseline|Cohort 2C|Cohort 2C: 100mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
1087424|NCT00597272|B5|Baseline|Cohort 2B|Cohort 2B: 75mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
1087425|NCT00597272|B4|Baseline|Cohort 2A|Cohort 2A: 50mcg QS-DG weeks 1, 2, 3, 8, 20, 32
1087426|NCT00597272|B3|Baseline|Cohort 1C|Cohort 1C: 100mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
1087427|NCT00597272|B2|Baseline|Cohort 1B|Cohort 1B: 75mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
1087428|NCT00597272|B1|Baseline|Cohort 1A|Cohort 1A: 50mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
1088316|NCT00594425|O3|Outcome|Vehicle PDT|
1087436|NCT00597272|O7|Outcome|Cohort 3|Cohort 3: 150mcg OPT-821 for first 5 vaccines with a 50 mcg increase in dose for the final vaccine.
1087437|NCT00597272|O6|Outcome|Cohort 2C|Cohort 2C: 100mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
1087438|NCT00597272|O5|Outcome|Cohort 2B|Cohort 2B: 75mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
1087439|NCT00597272|O4|Outcome|Cohort 2A|Cohort 2A: 50mcg QS-DG weeks 1, 2, 3, 8, 20, 32
1087440|NCT00597272|O3|Outcome|Cohort 1C|Cohort 1C: 100mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
1087441|NCT00597272|O2|Outcome|Cohort 1B|Cohort 1B: 75mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
1087442|NCT00597272|O1|Outcome|Cohort 1A|Cohort 1A: 50mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
1087443|NCT00597272|E7|Reported Event|Cohort 3|Cohort 3: 150mcg OPT-821 for first 5 vaccines with a 50 mcg increase in dose for the final vaccine.
1087444|NCT00597272|E6|Reported Event|Cohort 2C|Cohort 2C: 100mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
1087445|NCT00597272|E5|Reported Event|Cohort 2B|Cohort 2B: 75mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
1087446|NCT00597272|E4|Reported Event|Cohort 2A|Cohort 2A: 50mcg QS-DG weeks 1, 2, 3, 8, 20, 32
1087447|NCT00597272|E3|Reported Event|Cohort 1C|Cohort 1C: 100mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
1087448|NCT00597272|E2|Reported Event|Cohort 1B|Cohort 1B: 75mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
1087449|NCT00597272|E1|Reported Event|Cohort 1A|Cohort 1A: 50mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
1087450|NCT00597207|B3|Baseline|Total|Total of all reporting groups
1087451|NCT00597207|B2|Baseline|M-CPR|"Manual CPR All subjects initially receive manual chest compressions. After randomization, subjects randomized to M-CPR continue to receive manual chest compressions.~Manual: Manual chest compression"
1087452|NCT00597207|B1|Baseline|iA-CPR|"Integrated Mechanical CPR with AutoPulse All subjects initially receive manual chest compressions. After randomization, subjects randomized to iA-CPR are moved to the device once it is ready and from thereon receive mechanical chest compressions.~AutoPulse: Mechanical device that provides chest compression"
1087453|NCT00597207|P2|Participant Flow|M-CPR|"Manual CPR All subjects initially receive manual chest compressions. After randomization, subjects randomized to M-CPR continue to receive manual chest compressions.~Manual: Manual chest compression"
1087454|NCT00597207|P1|Participant Flow|iA-CPR|"Integrated Mechanical CPR with AutoPulse All subjects initially receive manual chest compressions. After randomization, subjects randomized to iA-CPR are moved to the device once it is ready and from thereon receive mechanical chest compressions.~AutoPulse: Mechanical device that provides chest compression"
1087455|NCT00597207|O2|Outcome|M-CPR|"Manual CPR All subjects initially receive manual chest compressions. After randomization, subjects randomized to M-CPR continue to receive manual chest compressions.~Manual: Manual chest compression"
1087456|NCT00597207|O1|Outcome|iA-CPR|"Integrated Mechanical CPR with AutoPulse All subjects initially receive manual chest compressions. After randomization, subjects randomized to iA-CPR are moved to the device once it is ready and from thereon receive mechanical chest compressions.~AutoPulse: Mechanical device that provides chest compression"
1087457|NCT00597207|E2|Reported Event|M-CPR|"Manual CPR All subjects initially receive manual chest compressions. After randomization, subjects randomized to M-CPR continue to receive manual chest compressions.~Manual: Manual chest compression"
1087458|NCT00597207|E1|Reported Event|iA-CPR|"Integrated Mechanical CPR with AutoPulse All subjects initially receive manual chest compressions. After randomization, subjects randomized to iA-CPR are moved to the device once it is ready and from thereon receive mechanical chest compressions.~AutoPulse: Mechanical device that provides chest compression"
1087459|NCT00597116|B3|Baseline|Total|Total of all reporting groups
1087460|NCT00597116|B2|Baseline|Vinorelbine|Vinorelbine 30 mg/m2 iv, administrated weekly
1087461|NCT00597116|B1|Baseline|Vandetanib|Vandetanib 300 mg/day oral
1087462|NCT00597116|P2|Participant Flow|Vinorelbine|Vinorelbine 30 mg/m2 iv, administrated weekly
1087463|NCT00597116|P1|Participant Flow|Vandetanib|Vandetanib 300 mg/day oral
1087464|NCT00597116|O2|Outcome|Vinorelbine|Vinorelbine 30 mg/m2 iv, administrated weekly
1087465|NCT00597116|O1|Outcome|Vandetanib|Vandetanib 300 mg/day oral
1087466|NCT00597116|O2|Outcome|Vinorelbine|Vinorelbine 30 mg/m2 iv, administrated weekly
1087467|NCT00597116|O1|Outcome|Vandetanib|Vandetanib 300 mg/day oral
1087468|NCT00597116|O2|Outcome|Vinorelbine|Vinorelbine 30 mg/m2 iv, administrated weekly
1087469|NCT00597116|O1|Outcome|Vandetanib|Vandetanib 300 mg/day oral
1087470|NCT00597116|O2|Outcome|Vinorelbine|Vinorelbine 30 mg/m2 iv, administrated weekly
1087471|NCT00597116|O1|Outcome|Vandetanib|Vandetanib 300 mg/day oral
1087472|NCT00597116|E2|Reported Event|Vinorelbine|Vinorelbine 30 mg/m2 iv, administrated weekly
1087473|NCT00597116|E1|Reported Event|Vandetanib|Vandetanib 300 mg/day oral
1087474|NCT00597038|B3|Baseline|Total|Total of all reporting groups
1087475|NCT00597038|B2|Baseline|Phase II Dose Treatment|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The recommended phase II dose was dasatinib 70 mg BID with dacarbazine 800 mgm^2.
1087476|NCT00597038|B1|Baseline|Phase I Dose Escalation|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The first cohort was a dasatinib dose of 50 mg by mouth (PO) twice a day (BID) given days 2-19 with DTIC given at a dose of 800 mg/m2 once every 3 weeks. The dose escalation was continued until MTD and a recommended Phase II dose was established.
1087477|NCT00597038|P2|Participant Flow|Phase II Dose Treatment|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The recommended phase II dose was dasatinib 70 mg BID with dacarbazine 800 mgm^2.
1087478|NCT00597038|P1|Participant Flow|Phase I Dose Escalation|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The first cohort was a dasatinib dose of 50 mg by mouth (PO) twice a day (BID) given days 2-19 with DTIC given at a dose of 800 mg/m2 once every 3 weeks. The dose escalation was continued until MTD and a recommended Phase II dose was established.
1087479|NCT00597038|O2|Outcome|Phase II Dose Treatment|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The recommended phase II dose was dasatinib 70 mg BID with dacarbazine 800 mgm^2.
1087480|NCT00597038|O1|Outcome|Phase I Dose Escalation|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The first cohort was a dasatinib dose of 50 mg by mouth (PO) twice a day (BID) given days 2-19 with DTIC given at a dose of 800 mg/m2 once every 3 weeks. The dose escalation was continued until MTD and a recommended Phase II dose was established.
1087481|NCT00597038|O1|Outcome|Phase II Dose Treatment|Dasatinib and Dacarbazine (DTIC)
1087482|NCT00597038|O1|Outcome|Phase II Dose Treatment|Dasatinib and Dacarbazine (DTIC)
1087483|NCT00597038|O1|Outcome|Phase I Dose Escalation|Dasatinib and Dacarbazine (DTIC)
1087484|NCT00597038|E2|Reported Event|Phase II Dose Treatment|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The recommended phase II dose was dasatinib 70 mg BID with dacarbazine 800 mgm^2.
1087485|NCT00597038|E1|Reported Event|Phase I Dose Escalation|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The first cohort was a dasatinib dose of 50 mg by mouth (PO) twice a day (BID) given days 2-19 with DTIC given at a dose of 800 mg/m2 once every 3 weeks. The dose escalation was continued until MTD and a recommended Phase II dose was established.
1087486|NCT00597012|B3|Baseline|Total|Total of all reporting groups
1087487|NCT00597012|B2|Baseline|Physical Therapy|Participants will undergo standard physical therapy that will include strengthening and stretching sessions one to three times a week for 8 weeks.
1087488|NCT00597012|B1|Baseline|Arthroscopic Partial Meniscectomy|Participants will undergo arthroscopic partial menisectomy (APM) surgery and offered postoperative rehabilitative physical therapy.
1087489|NCT00597012|P2|Participant Flow|Physical Therapy (PT)|Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
1087490|NCT00597012|P1|Participant Flow|Arthroscopic Partial Meniscectomy (APM)|Participants underwent arthroscopic partial menisectomy (APM) surgery and were offered postoperative rehabilitative physical therapy.
1087491|NCT00597012|O2|Outcome|Physical Therapy|Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
1087492|NCT00597012|O1|Outcome|Arthroscopic Partial Meniscectomy|Participants underwent arthroscopic partial menisectomy (APM) surgery and were referred for postoperative rehabilitative physical therapy.
1087493|NCT00597012|O2|Outcome|Physical Therapy|Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
1087494|NCT00597012|O1|Outcome|Arthroscopic Partial Meniscectomy|Participants underwent arthroscopic partial menisectomy (APM) surgery and were referred for postoperative rehabilitative physical therapy.
1087495|NCT00597012|O2|Outcome|Physical Therapy|Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
1087496|NCT00597012|O1|Outcome|Arthroscopic Partial Meniscectomy|Participants underwent arthroscopic partial menisectomy (APM) surgery and were referred for postoperative rehabilitative physical therapy.
1087497|NCT00597012|E2|Reported Event|Physical Therapy|Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
1087498|NCT00597012|E1|Reported Event|Arthroscopic Partial Meniscectomy|Participants underwent arthroscopic partial menisectomy (APM) surgery and were offered postoperative rehabilitative physical therapy.
1087499|NCT00596960|B3|Baseline|Total|Total of all reporting groups
1087500|NCT00596960|B2|Baseline|Arm 2|"health education intervention~Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training."
1087501|NCT00596960|B1|Baseline|Arm 1|"Motivational enhancement therapy~Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH."
1087502|NCT00596960|P2|Participant Flow|Arm 2|"health education intervention~Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training."
1087503|NCT00596960|P1|Participant Flow|Arm 1|"Motivational enhancement therapy~Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH."
1087504|NCT00596960|O2|Outcome|Arm 2|"health education intervention~Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training."
1087505|NCT00596960|O1|Outcome|Arm 1|"Motivational enhancement therapy~Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH."
1087506|NCT00596960|O2|Outcome|Arm 2|"health education intervention~Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training."
1087507|NCT00596960|O1|Outcome|Arm 1|"Motivational enhancement therapy~Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH."
1087508|NCT00596960|O2|Outcome|Arm 2|"health education intervention~Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training."
1087509|NCT00596960|O1|Outcome|Arm 1|"Motivational enhancement therapy~Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH."
1087510|NCT00596960|E2|Reported Event|Arm 2|"health education intervention~Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training."
1087511|NCT00596960|E1|Reported Event|Arm 1|"Motivational enhancement therapy~Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH."
1087512|NCT00596947|B3|Baseline|Total|Total of all reporting groups
1087557|NCT00596934|O1|Outcome|Metreleptin Treatment Arm|"Treatment group~metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
1088317|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1087562|NCT00596934|O1|Outcome|Metreleptin Treatment Arm|"Treatment group~metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
1087563|NCT00596934|O1|Outcome|Metreleptin Treatment Arm|"Treatment group~metreleptin: 0.1 mg/kg/day once a day via subcutaneous injections"
1088330|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1087513|NCT00596947|B2|Baseline|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
1087514|NCT00596947|B1|Baseline|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
1087515|NCT00596947|P2|Participant Flow|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
1087516|NCT00596947|P1|Participant Flow|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
1087517|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
1087518|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
1087519|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
1087520|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
1087521|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
1087522|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
1087523|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
1087524|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
1087525|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
1087526|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
1087558|NCT00596934|O1|Outcome|Metreleptin Treatment Arm|"Treatment group~metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
1087559|NCT00596934|O1|Outcome|Metreleptin Treatment Arm|"Treatment group~metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
1172352|NCT00381303|O1|Outcome|Female|
1087527|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
1087528|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
1087529|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
1087530|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
1087531|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
1087532|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
1087533|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
1087534|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
1087535|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
1087536|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
1087537|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
1087538|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
1087539|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
1087540|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
1087560|NCT00596934|O1|Outcome|Metreleptin Treatment Group|"Treatment group~metreleptin: 0.1 mg/kg/day once a day via subcutaneous injections"
1087561|NCT00596934|O1|Outcome|Metreleptin Treatment Arm|"Treatment group~metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
1088318|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1087541|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
1087542|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
1087543|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
1087544|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
1087545|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
1087546|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
1087547|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
1087548|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
1087549|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
1087550|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
1087551|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
1087552|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
1087553|NCT00596947|E2|Reported Event|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
1087554|NCT00596947|E1|Reported Event|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
1087555|NCT00596934|B1|Baseline|Metreleptin Treatment Arm|"Treatment group~metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
1087556|NCT00596934|P1|Participant Flow|NASH02|"Treatment group~metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
1088319|NCT00594425|O3|Outcome|Vehicle PDT|
1087564|NCT00596934|O1|Outcome|Metreleptin Treatment Arm|"Treatment group~metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
1087565|NCT00596934|E1|Reported Event|Metreleptin Treatment Arm|"Treatment group~metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
1087566|NCT00596830|B3|Baseline|Total|Total of all reporting groups
1087567|NCT00596830|B2|Baseline|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
1087568|NCT00596830|B1|Baseline|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
1087569|NCT00596830|P2|Participant Flow|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
1087570|NCT00596830|P1|Participant Flow|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
1087571|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
1087572|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
1087573|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
1087574|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
1087575|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
1087576|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
1087577|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
1087578|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
1087579|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
1087580|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
1087616|NCT00596817|E3|Reported Event|Vortioxetine: 5 or 10 mg - Double-blind Period (FAS)|
1087617|NCT00596817|E2|Reported Event|Placebo - Double-blind Period (FAS)|
1087618|NCT00596817|E1|Reported Event|Open-label Period (APTS)|
1087619|NCT00596752|B3|Baseline|Total|Total of all reporting groups
1087833|NCT00595946|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
1087710|NCT00596440|P2|Participant Flow|Relatives of Orthopedic Patients|Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling
1088331|NCT00594425|O3|Outcome|Vehicle PDT|
1087581|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
1087582|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
1087583|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
1087584|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
1087585|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
1087586|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
1087587|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
1087588|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
1087589|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
1087590|NCT00596830|E2|Reported Event|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
1087591|NCT00596830|E1|Reported Event|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
1087592|NCT00596817|B4|Baseline|Total|Total of all reporting groups
1087593|NCT00596817|B3|Baseline|Vortioxetine: 5 or 10 mg - Double-blind Period (FAS)|Vortioxetine (Lu AA21004) : encapsulated tablets, daily, orally
1087594|NCT00596817|B2|Baseline|Placebo - Double-blind Period (FAS)|Placebo : capsules, daily, orally
1087595|NCT00596817|B1|Baseline|Open-label Period (APTS)|
1087596|NCT00596817|P2|Participant Flow|Vortioxetine: 5 or 10 mg|Vortioxetine (Lu AA21004) : encapsulated tablets, daily, orally
1087597|NCT00596817|P1|Participant Flow|Placebo|Placebo : capsules, daily, orally
1087598|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
1087599|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
1087600|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
1087601|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
1087602|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
1087603|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
1087604|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
1087605|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
1087606|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
1087607|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
1087608|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
1087609|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
1087610|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
1087611|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
1087612|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
1087613|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
1087614|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
1087615|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
1087620|NCT00596752|B2|Baseline|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
1087621|NCT00596752|B1|Baseline|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
1087622|NCT00596752|P2|Participant Flow|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
1087623|NCT00596752|P1|Participant Flow|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
1087624|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
1087625|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
1087626|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
1087627|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
1087628|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
1087629|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
1087630|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
1087631|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
1087632|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
1087633|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
1087634|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
1087635|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
1087636|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
1087637|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
1087638|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
1087639|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
1087640|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
1087641|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
1087642|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
1087643|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
1087644|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
1087645|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
1087646|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
1087647|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
1087648|NCT00596752|E2|Reported Event|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
1087649|NCT00596752|E1|Reported Event|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
1087650|NCT00596687|B3|Baseline|Total|Total of all reporting groups
1087651|NCT00596687|B2|Baseline|SSRI|Sliding scale regular insulin four-times daily.
1087652|NCT00596687|B1|Baseline|Basal Bolus|Glargine and rapid-acting mealtime insulin plus supplemental glulisine
1087653|NCT00596687|P2|Participant Flow|SSRI|Sliding scale regular insulin four-times daily if blood glucose > 140 before meals and at bedtime. The sliding scale regimen was per the hospital protocol.
1087654|NCT00596687|P1|Participant Flow|Basal Bolus|Glargine and rapid-acting mealtime insulin plus supplemental glulisine. A total of 0.5 units of insulin/day given, half as basal glargine insulin once a day and the other half as mealtime glulisine given three times a day at meals.
1087655|NCT00596687|O2|Outcome|SSRI|Sliding scale regular insulin four-times daily.
1087656|NCT00596687|O1|Outcome|Basal Bolus|Glargine and rapid-acting mealtime insulin plus supplemental glulisine
1087657|NCT00596687|O2|Outcome|SSRI|Sliding scale regular insulin four-times daily.
1087658|NCT00596687|O1|Outcome|Basal Bolus|Glargine and rapid-acting mealtime insulin plus supplemental glulisine
1087659|NCT00596687|E2|Reported Event|SSRI|Sliding scale regular insulin four-times daily.
1087660|NCT00596687|E1|Reported Event|Basal Bolus|Glargine and rapid-acting mealtime insulin plus supplemental glulisine
1087661|NCT00596635|B4|Baseline|Total|Total of all reporting groups
1087662|NCT00596635|B3|Baseline|2 Cranberry Capsules|1 650 mg cranberry capsule twice daily (bid)
1087663|NCT00596635|B2|Baseline|One Cranberry Capsule|1 650mg cranberry capsule daily
1087664|NCT00596635|B1|Baseline|No Cranberry Capsules|Control Group No Cranberry Capsule
1087665|NCT00596635|P3|Participant Flow|2 Cranberry Capsules|1 650 mg cranberry capsule twice daily (bid)
1087666|NCT00596635|P2|Participant Flow|One Cranberry Capsule|1 650mg cranberry capsule daily
1087667|NCT00596635|P1|Participant Flow|No Cranberry Capsules|Control Group No Cranberry Capsule
1087668|NCT00596635|O3|Outcome|2 Cranberry Capsules|1 650 mg cranberry capsule twice daily (bid)
1087669|NCT00596635|O2|Outcome|One Cranberry Capsule|1 650mg cranberry capsule daily
1087670|NCT00596635|O1|Outcome|No Cranberry Capsules|Control Group No Cranberry Capsule
1087671|NCT00596635|O3|Outcome|2 Cranberry Capsules|1 650 mg cranberry capsule twice daily (bid)
1087672|NCT00596635|O2|Outcome|One Cranberry Capsule|1 650mg cranberry capsule daily
1087673|NCT00596635|O1|Outcome|No Cranberry Capsules|Control Group No Cranberry Capsule
1087674|NCT00596635|O3|Outcome|2 Cranberry Capsules|1 650 mg cranberry capsule twice daily (bid)
1087675|NCT00596635|O2|Outcome|One Cranberry Capsule|1 650mg cranberry capsule daily
1087676|NCT00596635|O1|Outcome|No Cranberry Capsules|Control Group No Cranberry Capsule
1087677|NCT00596635|E3|Reported Event|2 Cranberry Capsules|1 650 mg cranberry capsule twice daily (bid)
1087678|NCT00596635|E2|Reported Event|One Cranberry Capsule|1 650mg cranberry capsule daily
1087679|NCT00596635|E1|Reported Event|No Cranberry Capsules|Control Group No Cranberry Capsule
1087680|NCT00596622|B4|Baseline|Total|Total of all reporting groups
1087681|NCT00596622|B3|Baseline|Bipolar Euthymic Subjects Treated With Lithium|"Participants with bipolar mania picture response during fMRI before and after treatment with lithium~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.~Depression and mania scores before and after treatment"
1087774|NCT00596102|B3|Baseline|Placebo|no treatment in study IC51-303, vaccinations were performed in preceeding study IC51-302
1087682|NCT00596622|B2|Baseline|Bipolar Manic Subjects Treated With Lithium|"Participants with bipolar mania picture response during fMRI before and after treatment with lithium~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.~Depression and mania scores before and after treatment"
1087683|NCT00596622|B1|Baseline|Bipolar Depressed Subjects Treated With Lithium|"Participants with bipolar depression picture response during fMRI before and after treatment with lithium~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.~Depression and mania scores before and after treatment"
1087684|NCT00596622|P1|Participant Flow|Bipolar Subjects Who Were Included in Lithium Treatment Arm|"Participants with bipolar disorder who undergo fMRI and lithium treatment~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.~Picture response during fMRI: While undergoing an fMRI scan, participants will be presented with pictures, letters, words, and sounds to evoke emotional responses. There will be a maximum of three MRI scans over 9 weeks."
1087685|NCT00596622|O3|Outcome|Bipolar Euthymic Subjects Treated|"Bipolar euthymia picture response before and after treatment with lithium~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment."
1087686|NCT00596622|O2|Outcome|Bipolar Depressed Subjects Treated|"Bipolar depression picture response during fMRI before and after treatment with lithium~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment."
1087687|NCT00596622|O1|Outcome|Bipolar Manic Subjects Treated|"Bipolar mania picture response during fMRI before and after treatment with lithium~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment."
1087688|NCT00596622|O3|Outcome|Bipolar Euthymic Subjects Treated|"Participants with bipolar euthymia who undergo fMRI and lithium treatment~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.~Picture response during fMRI: While undergoing an fMRI scan, participants will be presented with pictures, letters, words, and sounds to evoke emotional responses. There will be a maximum of three MRI scans over 9 weeks"
1087689|NCT00596622|O2|Outcome|Bipolar Manic Subjects Treated|"Participants with bipolar mania who undergo fMRI and lithium treatment~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.~Picture response during fMRI: While undergoing an fMRI scan, participants will be presented with pictures, letters, words, and sounds to evoke emotional responses. There will be a maximum of three MRI scans over 9 weeks"
1087690|NCT00596622|O1|Outcome|Bipolar Depressed Participants Treated|"Participants with bipolar depression who undergo fMRI and lithium treatment~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.~Picture response during fMRI: While undergoing an fMRI scan, participants will be presented with pictures, letters, words, and sounds to evoke emotional responses. There will be a maximum of three MRI scans over 9 weeks."
1087691|NCT00596622|E1|Reported Event|Bipolar Participants Treated|"Participants with bipolar disorder who undergo fMRI and lithium treatment~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.~Picture response during fMRI: While undergoing an fMRI scan, participants will be presented with pictures, letters, words, and sounds to evoke emotional responses. There will be a maximum of three MRI scans over 9 weeks.~Adverse Events information was collected irrespective of the sub-grouping"
1087692|NCT00596466|B1|Baseline|Pregabalin|Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
1087693|NCT00596466|P1|Participant Flow|Pregabalin|Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
1087694|NCT00596466|O1|Outcome|Pregabalin|Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
1087695|NCT00596466|O1|Outcome|Pregabalin|Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
1087696|NCT00596466|O1|Outcome|Pregabalin|Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
1087697|NCT00596466|E1|Reported Event|Pregabalin|Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
1087698|NCT00596453|B3|Baseline|Total|Total of all reporting groups
1087699|NCT00596453|B2|Baseline|Ciprofloxacin Hydrochloride|Ciprofloxacin hydrochloride: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days
1087700|NCT00596453|B1|Baseline|Placebo|Placebo: Placebo twice a day for 14 days
1087701|NCT00596453|P2|Participant Flow|Ciprofloxacin Hydrochloride|Ciprofloxacin hydrochloride: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days
1087702|NCT00596453|P1|Participant Flow|Placebo|Placebo: Placebo twice a day for 14 days
1087703|NCT00596453|O2|Outcome|Ciprofloxacin Hydrochloride|Ciprofloxacin hydrochloride: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days
1087704|NCT00596453|O1|Outcome|Placebo|Placebo: Placebo twice a day for 14 days
1087705|NCT00596453|E2|Reported Event|Ciprofloxacin Hydrochloride|Ciprofloxacin hydrochloride: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days
1087706|NCT00596453|E1|Reported Event|Placebo|Placebo: Placebo twice a day for 14 days
1087707|NCT00596440|B3|Baseline|Total|Total of all reporting groups
1087708|NCT00596440|B2|Baseline|Relatives of Orthopedic Patients|Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling
1087709|NCT00596440|B1|Baseline|Relatives of Cancer Patients|Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.
1088320|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1087711|NCT00596440|P1|Participant Flow|Relatives of Cancer Patients|Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.
1087712|NCT00596440|O2|Outcome|Relatives of Orthopedic Patients|Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling
1087713|NCT00596440|O1|Outcome|Relatives of Cancer Patients|Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.
1087714|NCT00596440|O2|Outcome|Relatives of Orthopedic Patients|Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling
1087715|NCT00596440|O1|Outcome|Relatives of Cancer Patients|Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.
1087716|NCT00596440|O2|Outcome|Relatives of Orthopedic Patients|Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling
1087717|NCT00596440|O1|Outcome|Relatives of Cancer Patients|Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.
1087718|NCT00596440|E2|Reported Event|Relatives of Orthopedic Patients|Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling
1087719|NCT00596440|E1|Reported Event|Relatives of Cancer Patients|Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.
1087720|NCT00596427|B3|Baseline|Total|Total of all reporting groups
1087721|NCT00596427|B2|Baseline|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of matched placebo(3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
1087722|NCT00596427|B1|Baseline|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
1087723|NCT00596427|P2|Participant Flow|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of matched placebo(3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
1087724|NCT00596427|P1|Participant Flow|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
1087725|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
1087726|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
1087727|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
1087728|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
1087729|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
1087730|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
1087731|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
1087732|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
1087733|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
1087734|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
1087735|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
1087736|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
1087737|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
1087738|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
1087739|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
1087740|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
1087741|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
1087775|NCT00596102|B2|Baseline|JE-VAX|no active treatment in study IC51-303, vaccinations were performed in preceeding study IC51-301
1172353|NCT00381303|O7|Outcome|Other|
1087742|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
1087743|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
1087744|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75grams/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
1087745|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
1087746|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
1087747|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
1087748|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
1087749|NCT00596427|E2|Reported Event|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of matched placebo(3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
1087750|NCT00596427|E1|Reported Event|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
1087751|NCT00596362|B1|Baseline|AVASTIN|AVASTIN: a single injection of Avastin at the outpatient clinic. This will be done as follows: the pupil in the eye being treated will be enlarged with a liquid solution. Thirty minutes later, a numbing solution and then a cleansing solution will be put in to the eye. Finally, an injection of Avastin will be given into the eye. Right after this injection, your eye will be examined by your doctor. The pressure in your eye will also be tested before and after the injection. Patients will use antibiotic drops for 5 days following the injection. Following the injection, you will have weekly examinations for four weeks in the office.
1087752|NCT00596362|P1|Participant Flow|AVASTIN|AVASTIN: a single injection of Avastin at the outpatient clinic. This will be done as follows: the pupil in the eye being treated will be enlarged with a liquid solution. Thirty minutes later, a numbing solution and then a cleansing solution will be put in to the eye. Finally, an injection of Avastin will be given into the eye. Right after this injection, your eye will be examined by your doctor. The pressure in your eye will also be tested before and after the injection. Patients will use antibiotic drops for 5 days following the injection. Following the injection, you will have weekly examinations for four weeks in the office.
1087753|NCT00596362|O1|Outcome|AVASTIN|AVASTIN: a single injection of Avastin at the outpatient clinic. This will be done as follows: the pupil in the eye being treated will be enlarged with a liquid solution. Thirty minutes later, a numbing solution and then a cleansing solution will be put in to the eye. Finally, an injection of Avastin will be given into the eye. Right after this injection, your eye will be examined by your doctor. The pressure in your eye will also be tested before and after the injection. Patients will use antibiotic drops for 5 days following the injection. Following the injection, you will have weekly examinations for four weeks in the office.
1087754|NCT00596362|E1|Reported Event|AVASTIN|AVASTIN: a single injection of Avastin at the outpatient clinic. This will be done as follows: the pupil in the eye being treated will be enlarged with a liquid solution. Thirty minutes later, a numbing solution and then a cleansing solution will be put in to the eye. Finally, an injection of Avastin will be given into the eye. Right after this injection, your eye will be examined by your doctor. The pressure in your eye will also be tested before and after the injection. Patients will use antibiotic drops for 5 days following the injection. Following the injection, you will have weekly examinations for four weeks in the office.
1087755|NCT00596271|B4|Baseline|Total|Total of all reporting groups
1087756|NCT00596271|B3|Baseline|IC51 and HAVRIX|IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0)
1087757|NCT00596271|B2|Baseline|HAVRIX and Placebo|HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28)
1087758|NCT00596271|B1|Baseline|IC51 and Placebo|6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0)
1087759|NCT00596271|P3|Participant Flow|IC51 and HAVRIX|IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0)
1087760|NCT00596271|P2|Participant Flow|HAVRIX and Placebo|HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28)
1087761|NCT00596271|P1|Participant Flow|IC51 and Placebo|6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0)
1087762|NCT00596271|O2|Outcome|IC51 + HAVRIX|
1087763|NCT00596271|O1|Outcome|HAVRIX + Placebo|
1087764|NCT00596271|O2|Outcome|IC51 and HAVRIX|
1087765|NCT00596271|O1|Outcome|IC51 and Placebo|
1087766|NCT00596271|E3|Reported Event|IC51 and HAVRIX|IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0)
1087767|NCT00596271|E2|Reported Event|HAVRIX and Placebo|HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28)
1087768|NCT00596271|E1|Reported Event|IC51 and Placebo|6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0)
1087769|NCT00596167|B1|Baseline|Intravenous Antibiotics|This study will have only one arm. This will be the experimental arm receiving the intravenous antibiotics, levofloxacin, vancomycin and gentamicin.
1087770|NCT00596167|P1|Participant Flow|Intravenous Antibiotics|This study will have only one arm. This will be the experimental arm receiving the intravenous antibiotics, levofloxacin, vancomycin and gentamicin.
1087771|NCT00596167|O1|Outcome|Intravenous Antibiotic (Vancomycin)|This study will have only one arm. All six participants in the study will receive an intravenous dose of the intravenous antibiotics, levofloxacin, vancomycin and gentamicin.
1087772|NCT00596167|E1|Reported Event|Intravenous Antibiotics|This study will have only one arm. This will be the experimental arm receiving the intravenous antibiotics, levofloxacin, vancomycin and gentamicin.
1087773|NCT00596102|B4|Baseline|Total|Total of all reporting groups
1087776|NCT00596102|B1|Baseline|IC51|no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302
1176891|NCT00367835|O2|Outcome|Placebo|
1087777|NCT00596102|P3|Participant Flow|Placebo|no treatment in study IC51-303, vaccinations were performed in preceeding study IC51-302
1087778|NCT00596102|P2|Participant Flow|JE-VAX|no active treatment in study IC51-303, vaccinations were performed in preceeding study IC51-301
1087779|NCT00596102|P1|Participant Flow|IC51|no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302
1087780|NCT00596102|O1|Outcome|IC51|no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302
1087781|NCT00596102|E4|Reported Event|IC51 Month 60|no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 60
1087782|NCT00596102|E3|Reported Event|Placebo|no active treatment in study IC51-303, Plarcebo vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 6
1087783|NCT00596102|E2|Reported Event|JE-VAX|no active treatment in study IC51-303, JE-VAX vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 6
1087784|NCT00596102|E1|Reported Event|IC51 Month 6|no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 6
1087785|NCT00596011|B3|Baseline|Total|Total of all reporting groups
1087786|NCT00596011|B2|Baseline|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
1087787|NCT00596011|B1|Baseline|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
1087788|NCT00596011|P2|Participant Flow|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
1087789|NCT00596011|P1|Participant Flow|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
1087790|NCT00596011|O2|Outcome|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
1087791|NCT00596011|O1|Outcome|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
1087792|NCT00596011|O2|Outcome|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
1087793|NCT00596011|O1|Outcome|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
1087794|NCT00596011|O2|Outcome|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
1087795|NCT00596011|O1|Outcome|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
1087796|NCT00596011|O2|Outcome|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
1087797|NCT00596011|O1|Outcome|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
1087798|NCT00596011|O2|Outcome|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
1087799|NCT00596011|O1|Outcome|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
1087800|NCT00596011|O2|Outcome|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
1087801|NCT00596011|O1|Outcome|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
1087802|NCT00596011|E2|Reported Event|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
1087803|NCT00596011|E1|Reported Event|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
1087804|NCT00595959|B1|Baseline|Laser Treatment|CLiRpath Photoablation Atherectomy System
1087805|NCT00595959|P1|Participant Flow|Laser Treatment|CLiRpath Photoablation Atherectomy System
1087806|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
1087807|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
1087808|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
1087809|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
1087810|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
1087811|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
1087812|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
1087813|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
1087814|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
1087815|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
1087816|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
1087817|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
1087818|NCT00595959|E1|Reported Event|Laser Treatment|CLiRpath Photoablation Atherectomy System
1087819|NCT00595946|B3|Baseline|Total|Total of all reporting groups
1087820|NCT00595946|B2|Baseline|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
1087821|NCT00595946|B1|Baseline|Placebo|Placebo : 0 mcg capsules twice daily (BID)
1087822|NCT00595946|P2|Participant Flow|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID) for up to 12 weeks
1087823|NCT00595946|P1|Participant Flow|Placebo|Placebo : 0 mcg capsules twice daily (BID) for up to 12 weeks
1087824|NCT00595946|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
1087825|NCT00595946|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
1087826|NCT00595946|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
1087827|NCT00595946|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
1087828|NCT00595946|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
1087829|NCT00595946|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
1087830|NCT00595946|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
1087831|NCT00595946|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
1087832|NCT00595946|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
1087834|NCT00595946|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
1087835|NCT00595946|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
1087836|NCT00595946|E2|Reported Event|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
1087837|NCT00595946|E1|Reported Event|Placebo|Placebo : 0 mcg capsules twice daily (BID)
1087838|NCT00595920|B1|Baseline|Open Label Extension|"30-45 million autologous myelin reactive T cells~Tovaxin: 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required."
1087839|NCT00595920|P1|Participant Flow|Open Label Extension|"30-45 million autologous myelin reactive T cells~Tovaxin: 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required."
1087840|NCT00595920|O1|Outcome|Open Label Extension|"30-45 million autologous myelin reactive T cells~Tovaxin: 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required."
1087841|NCT00595920|E1|Reported Event|Open Label Extension|"30-45 million autologous myelin reactive T cells~Tovaxin: 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required."
1087842|NCT00595881|B1|Baseline|Ultrasound|One group of patients will undergo emergency bedside ultrasound in addition to the clinical examination.
1087843|NCT00595881|P1|Participant Flow|Ultrasound|One group of patients will undergo emergency bedside ultrasound in addition to the clinical examination.
1087844|NCT00595881|O2|Outcome|Clinical Exam+ Ultrasound|Patients will have data collected following the addition of a bedside ultrasound performed to the clinical exam.
1087845|NCT00595881|O1|Outcome|Clinical Exam Alone|Patients will have data collected from their clinical examination alone
1087846|NCT00595881|E1|Reported Event|Ultrasound|One group of patients will undergo emergency bedside ultrasound in addition to the clinical examination.
1087847|NCT00595868|B3|Baseline|Total|Total of all reporting groups
1087848|NCT00595868|B2|Baseline|Placebo|Placebo once per day for 2-8 weeks
1087849|NCT00595868|B1|Baseline|Varenicline|2 milligrams varenicline once per day for 2-8 weeks
1087850|NCT00595868|P2|Participant Flow|Placebo|Placebo once per day for 2-8 weeks
1087851|NCT00595868|P1|Participant Flow|Varenicline|2 milligrams varenicline once per day for 2-8 weeks
1087852|NCT00595868|O2|Outcome|Placebo|Placebo once per day for 2-8 weeks
1087853|NCT00595868|O1|Outcome|Varenicline|2 milligrams varenicline once per day for 2-8 weeks
1087854|NCT00595868|O2|Outcome|Placebo|Placebo once per day for 2-8 weeks
1087855|NCT00595868|O1|Outcome|Varenicline|2 milligrams varenicline once per day for 2-8 weeks
1087856|NCT00595868|E2|Reported Event|Placebo|Placebo once per day for 2-8 weeks
1087857|NCT00595868|E1|Reported Event|Varenicline|2 milligrams varenicline once per day for 2-8 weeks
1087858|NCT00595790|B4|Baseline|Total|Total of all reporting groups
1087859|NCT00595790|B3|Baseline|IC51 1 x 6 mcg|1 x 6 mcg (microgram)
1087860|NCT00595790|B2|Baseline|IC51 1 x 12 mcg|1 x 12 mcg (microgram)
1087861|NCT00595790|B1|Baseline|IC51 2 x 6 mcg|2 x 6 mcg (microgram)
1087862|NCT00595790|P3|Participant Flow|IC51 1 x 6 mcg|1 x 6 mcg (microgram)
1087863|NCT00595790|P2|Participant Flow|IC51 1 x 12 mcg|1 x 12 mcg (microgram)
1087864|NCT00595790|P1|Participant Flow|IC51 2 x 6 mcg|2 x 6 mcg (microgram)
1087865|NCT00595790|O3|Outcome|IC51 1x6 mcg|
1087866|NCT00595790|O2|Outcome|IC51 2x6 mcg|
1087867|NCT00595790|O1|Outcome|IC51 1 x 12 mcg|
1087868|NCT00595790|E3|Reported Event|IC51 1 x 6 mcg|1 x 6 mcg (microgram)
1087869|NCT00595790|E2|Reported Event|IC51 1 x 12 mcg|1 x 12 mcg (microgram)
1087870|NCT00595790|E1|Reported Event|IC51 2 x 6 mcg|2 x 6 mcg (microgram)
1087871|NCT00595764|B3|Baseline|Total|Total of all reporting groups
1087872|NCT00595764|B2|Baseline|Physician Management Plus Cognitive Behavioral Therapy|In addition to receiving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
1087873|NCT00595764|B1|Baseline|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient’s recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
1087874|NCT00595764|P2|Participant Flow|Physician Management Plus Cognitive Behavioral Therapy|In addition to recieving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
1087903|NCT00595556|O2|Outcome|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
1087904|NCT00595556|O1|Outcome|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
1087978|NCT00595413|E1|Reported Event|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
1087875|NCT00595764|P1|Participant Flow|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient’s recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
1087876|NCT00595764|O2|Outcome|Physician Management Plus Cognitive Behavioral Therapy|In addition to receiving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
1087877|NCT00595764|O1|Outcome|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient's recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
1087878|NCT00595764|O2|Outcome|Physician Management Plus Cognitive Behavioral Therapy|In addition to receiving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
1087879|NCT00595764|O1|Outcome|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient's recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
1087880|NCT00595764|O2|Outcome|Physician Management Plus Cognitive Behavioral Therapy|In addition to receiving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
1087881|NCT00595764|O1|Outcome|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient's recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
1087882|NCT00595764|O2|Outcome|Physician Management Plus Cognitive Behavioral Therapy|In addition to receiving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
1087883|NCT00595764|O1|Outcome|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient's recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
1087905|NCT00595556|O2|Outcome|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
1087906|NCT00595556|O1|Outcome|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
1087947|NCT00595413|B4|Baseline|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
1172354|NCT00381303|O6|Outcome|Asian|
1087884|NCT00595764|O2|Outcome|Physician Management Plus Cognitive Behavioral Therapy|In addition to receiving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
1087885|NCT00595764|O1|Outcome|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient's recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
1087886|NCT00595764|E2|Reported Event|Physician Management Plus Cognitive Behavioral Therapy|In addition to recieving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
1087887|NCT00595764|E1|Reported Event|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient’s recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
1087888|NCT00595582|B1|Baseline|Curcumin + Bioperine|Subjects who are currently in the primary Mild Cognitive Impairment study will be asked to be treated with 5.4 grams of curcumin + bioperine per day (900 mg pills, two pills 3x/day with meals) for 24 months concordant with the last two years of the primary longitudinal Mild Cognitive Impairment study.
1087889|NCT00595582|P1|Participant Flow|Curcumin + Bioperine|Subjects who are currently in the primary Mild Cognitive Impairment study will be asked to be treated with 5.4 grams of curcumin + bioperine per day (900 mg pills, two pills 3x/day with meals) for 24 months concordant with the last two years of the primary longitudinal Mild Cognitive Impairment study.
1087890|NCT00595582|O1|Outcome|Curcumin + Bioperine|Subjects who are currently in the primary Mild Cognitive Impairment study will be asked to be treated with 5.4 grams of curcumin + bioperine per day (900 mg pills, two pills 3x/day with meals) for 24 months concordant with the last two years of the primary longitudinal Mild Cognitive Impairment study.
1087891|NCT00595582|E1|Reported Event|Curcumin + Bioperine|Subjects who are currently in the primary Mild Cognitive Impairment study will be asked to be treated with 5.4 grams of curcumin + bioperine per day (900 mg pills, two pills 3x/day with meals) for 24 months concordant with the last two years of the primary longitudinal Mild Cognitive Impairment study.
1087892|NCT00595556|B3|Baseline|Total|Total of all reporting groups
1087893|NCT00595556|B2|Baseline|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
1087894|NCT00595556|B1|Baseline|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
1087895|NCT00595556|P2|Participant Flow|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
1087896|NCT00595556|P1|Participant Flow|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
1087897|NCT00595556|O2|Outcome|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
1087898|NCT00595556|O1|Outcome|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
1087899|NCT00595556|O2|Outcome|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
1087900|NCT00595556|O1|Outcome|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
1087901|NCT00595556|O2|Outcome|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
1087902|NCT00595556|O1|Outcome|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
1088321|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1088322|NCT00594425|O3|Outcome|Vehicle PDT|
1087907|NCT00595556|E2|Reported Event|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
1087908|NCT00595556|E1|Reported Event|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
1087909|NCT00595530|B1|Baseline|Protocol for Administering Ketamine to Patients|"This group will receive ketamine~ketamine: The medication will be administered intravenously. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hour, 0.1 mg/kg/hour, 0.15 mg/kg/hour, and 0.2 mg/kg/hour.~Dosing Regimen:~All patients will begin the ketamine infusion at 0.05 mg/kg/hour.~4 or more hours after the infusion is started, the dose may be increased to 0.1 mg/kg/hour if:~the patient's pain has not improved to an acceptable level (pain score is still ≥5)~side effects remain acceptable~4 hours or more after the previous increase, the dose may be adjusted to 0.15 mg/kg/hour~4 hours or more after the previous increase, the dose may be adjusted to 0.2 mg/kg/hour~The maximum dose of ketamine will be limited to 300 mg per 24 hours~The patient may receive ketamine up to 72 hours after initiation."
1087910|NCT00595530|P1|Participant Flow|Procedure for Administering Ketamine to SCDpatients|"This group will receive ketamine~ketamine: The medication will be administered intravenously. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hour, 0.1 mg/kg/hour, 0.15 mg/kg/hour, and 0.2 mg/kg/hour.~Dosing Regimen:~All patients will begin the ketamine infusion at 0.05 mg/kg/hour.~4 or more hours after the infusion is started, the dose may be increased to 0.1 mg/kg/hour if:~the patient's pain has not improved to an acceptable level (pain score is still ≥5)~side effects remain acceptable~4 hours or more after the previous increase, the dose may be adjusted to 0.15 mg/kg/hour~4 hours or more after the previous increase, the dose may be adjusted to 0.2 mg/kg/hour~The maximum dose of ketamine will be limited to 300 mg per 24 hours~The patient may receive ketamine up to 72 hours after initiation."
1087911|NCT00595530|O1|Outcome|Ketamine|"This group will receive ketamine~ketamine: The medication will be administered intravenously. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hour, 0.1 mg/kg/hour, 0.15 mg/kg/hour, and 0.2 mg/kg/hour.~Dosing Regimen:~All patients will begin the ketamine infusion at 0.05 mg/kg/hour.~4 or more hours after the infusion is started, the dose may be increased to 0.1 mg/kg/hour if:~the patient's pain has not improved to an acceptable level (pain score is still ≥5)~side effects remain acceptable~4 hours or more after the previous increase, the dose may be adjusted to 0.15 mg/kg/hour~4 hours or more after the previous increase, the dose may be adjusted to 0.2 mg/kg/hour~The maximum dose of ketamine will be limited to 300 mg per 24 hours~The patient may receive ketamine up to 72 hours after initiation."
1087912|NCT00595530|E1|Reported Event|Ketamine|"This group will receive ketamine~ketamine: The medication will be administered intravenously. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hour, 0.1 mg/kg/hour, 0.15 mg/kg/hour, and 0.2 mg/kg/hour.~Dosing Regimen:~All patients will begin the ketamine infusion at 0.05 mg/kg/hour.~4 or more hours after the infusion is started, the dose may be increased to 0.1 mg/kg/hour if:~the patient's pain has not improved to an acceptable level (pain score is still ≥5)~side effects remain acceptable~4 hours or more after the previous increase, the dose may be adjusted to 0.15 mg/kg/hour~4 hours or more after the previous increase, the dose may be adjusted to 0.2 mg/kg/hour~The maximum dose of ketamine will be limited to 300 mg per 24 hours~The patient may receive ketamine up to 72 hours after initiation."
1087913|NCT00595517|B1|Baseline|Esomeprazole 20mg|Esomeprazole 20 mg once daily oral
1087914|NCT00595517|P1|Participant Flow|Esomeprazole 20mg|Esomeprazole 20 mg once daily oral
1087915|NCT00595517|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20 mg once daily oral
1087916|NCT00595517|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20 mg once daily oral
1087917|NCT00595517|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20 mg once daily oral
1087918|NCT00595517|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20 mg once daily oral
1087919|NCT00595517|E1|Reported Event|Esomeprazole 20mg|Esomeprazole 20 mg once daily oral
1087920|NCT00595504|B3|Baseline|Total|Total of all reporting groups
1087921|NCT00595504|B2|Baseline|Placebo|sugar pill
1087922|NCT00595504|B1|Baseline|Ramelteon|
1087923|NCT00595504|P2|Participant Flow|Placebo|sugar pill
1087924|NCT00595504|P1|Participant Flow|Ramelteon|
1087925|NCT00595504|O2|Outcome|Placebo (Sugar Pill)|A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
1087926|NCT00595504|O1|Outcome|Ramelteon|A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
1087927|NCT00595504|O2|Outcome|Placebo (Sugar Pill)|A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
1087928|NCT00595504|O1|Outcome|Ramelteon|A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
1087929|NCT00595504|O2|Outcome|Placebo (Sugar Pill)|A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
1087930|NCT00595504|O1|Outcome|Ramelteon|A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
1087931|NCT00595504|E2|Reported Event|Placebo|sugar pill
1087932|NCT00595504|E1|Reported Event|Ramelteon|
1087933|NCT00595465|B4|Baseline|Total|Total of all reporting groups
1087934|NCT00595465|B3|Baseline|IC51 Batch IC51/07E/008A|
1087935|NCT00595465|B2|Baseline|IC51 Batch IC51/07E/007A|
1087936|NCT00595465|B1|Baseline|IC51 Batch IC51/07E/006A|
1087937|NCT00595465|P3|Participant Flow|IC51 Batch IC51/07E/008A|
1087938|NCT00595465|P2|Participant Flow|IC51 Batch IC51/07E/007A|
1087939|NCT00595465|P1|Participant Flow|IC51 Batch IC51/07E/006A|
1087940|NCT00595465|O3|Outcome|IC51 Batch IC51/07E/008A|
1087941|NCT00595465|O2|Outcome|IC51 Batch IC51/07E/007A|
1087942|NCT00595465|O1|Outcome|IC51 Batch IC51/07E/006A|
1087943|NCT00595465|E3|Reported Event|IC51 Batch IC51/07E/008A|
1087944|NCT00595465|E2|Reported Event|IC51 Batch IC51/07E/007A|
1087945|NCT00595465|E1|Reported Event|IC51 Batch IC51/07E/006A|
1087946|NCT00595413|B5|Baseline|Total|Total of all reporting groups
1087948|NCT00595413|B3|Baseline|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
1087949|NCT00595413|B2|Baseline|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
1087950|NCT00595413|B1|Baseline|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
1087951|NCT00595413|P4|Participant Flow|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
1087952|NCT00595413|P3|Participant Flow|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
1087953|NCT00595413|P2|Participant Flow|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
1087954|NCT00595413|P1|Participant Flow|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
1087955|NCT00595413|O4|Outcome|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
1087956|NCT00595413|O3|Outcome|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
1087957|NCT00595413|O2|Outcome|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
1087958|NCT00595413|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
1087959|NCT00595413|O4|Outcome|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
1087960|NCT00595413|O3|Outcome|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
1087961|NCT00595413|O2|Outcome|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
1087962|NCT00595413|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
1087963|NCT00595413|O4|Outcome|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
1087964|NCT00595413|O3|Outcome|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
1087965|NCT00595413|O2|Outcome|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
1087966|NCT00595413|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
1087967|NCT00595413|O4|Outcome|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
1087968|NCT00595413|O3|Outcome|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
1087969|NCT00595413|O2|Outcome|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
1087970|NCT00595413|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
1087971|NCT00595413|O4|Outcome|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
1087972|NCT00595413|O3|Outcome|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
1087973|NCT00595413|O2|Outcome|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
1087974|NCT00595413|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
1087975|NCT00595413|E4|Reported Event|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
1087976|NCT00595413|E3|Reported Event|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
1087977|NCT00595413|E2|Reported Event|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
1088041|NCT00595153|O1|Outcome|Healthy Control|Healthy, non-asthmatics who will not be put on any intervention
1087980|NCT00595361|B2|Baseline|Gly/Gly|"Gly/Gly subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
1087981|NCT00595361|B1|Baseline|Arg/Arg|"Arg/Arg subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
1087982|NCT00595361|P2|Participant Flow|Gly/Gly|"Gly/Gly subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
1087983|NCT00595361|P1|Participant Flow|Arg/Arg|"Arg/Arg subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
1087984|NCT00595361|O2|Outcome|Gly/Gly|"Gly/Gly subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
1087985|NCT00595361|O1|Outcome|Arg/Arg|"Arg/Arg subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
1087986|NCT00595361|O2|Outcome|Gly/Gly|"Gly/Gly subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
1087987|NCT00595361|O1|Outcome|Arg/Arg|"Arg/Arg subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
1087988|NCT00595361|O2|Outcome|Gly/Gly|"Gly/Gly subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
1087989|NCT00595361|O1|Outcome|Arg/Arg|"Arg/Arg subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
1087990|NCT00595361|E2|Reported Event|Gly/Gly|"Gly/Gly subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
1087991|NCT00595361|E1|Reported Event|Arg/Arg|"Arg/Arg subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
1087992|NCT00595335|B3|Baseline|Total|Total of all reporting groups
1087993|NCT00595335|B2|Baseline|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
1087994|NCT00595335|B1|Baseline|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
1087995|NCT00595335|P2|Participant Flow|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
1087996|NCT00595335|P1|Participant Flow|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
1087997|NCT00595335|O2|Outcome|Placebo|Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.
1087998|NCT00595335|O1|Outcome|Rituximab|Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.
1087999|NCT00595335|O2|Outcome|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
1088000|NCT00595335|O1|Outcome|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
1088001|NCT00595335|O2|Outcome|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
1088002|NCT00595335|O1|Outcome|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
1088003|NCT00595335|O2|Outcome|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
1088004|NCT00595335|O1|Outcome|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
1088005|NCT00595335|O2|Outcome|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
1088006|NCT00595335|O1|Outcome|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
1088085|NCT00595075|E1|Reported Event|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
1088086|NCT00594958|B4|Baseline|Total|Total of all reporting groups
1088007|NCT00595335|O2|Outcome|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
1088008|NCT00595335|O1|Outcome|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
1088009|NCT00595335|O2|Outcome|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
1088010|NCT00595335|O1|Outcome|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
1088011|NCT00595335|O2|Outcome|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
1088012|NCT00595335|O1|Outcome|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
1088013|NCT00595335|E2|Reported Event|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
1088014|NCT00595335|E1|Reported Event|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
1088015|NCT00595309|B1|Baseline|IC51 Booster Group|IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization in study IC51-309
1088016|NCT00595309|P1|Participant Flow|IC51 Booster Group|IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization in study IC51-309
1088017|NCT00595309|O1|Outcome|IC51 Booster Group|IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization in study IC51-309
1088018|NCT00595309|E1|Reported Event|IC51 Booster Group|IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization in study IC51-309
1088019|NCT00595270|B4|Baseline|Total|Total of all reporting groups
1088020|NCT00595270|B3|Baseline|IC51 1 x 6 µg|treatment group in preceeding study IC51-304
1088021|NCT00595270|B2|Baseline|IC51 1 x 12 µg|treatment group in preceeding study IC51-304
1088022|NCT00595270|B1|Baseline|IC51 2 x 6 µg|treatment group in preceeding study IC51-304
1088023|NCT00595270|P3|Participant Flow|IC51 1 x 6 µg|treatment group in preceeding study IC51-304
1088024|NCT00595270|P2|Participant Flow|IC51 1 x 12 µg|treatment group in preceeding study IC51-304
1088025|NCT00595270|P1|Participant Flow|IC51 2 x 6 µg|treatment group in preceeding study IC51-304
1088026|NCT00595270|O3|Outcome|IC51 1 x 6 µg|treatment group in preceeding study IC51-304
1088027|NCT00595270|O2|Outcome|IC51 1 x 12 µg|treatment group in preceeding study IC51-304
1088028|NCT00595270|O1|Outcome|IC51 2 x 6 µg|treatment group in preceeding study IC51-304
1088029|NCT00595270|E3|Reported Event|IC51 1 x 6 µg|treatment group in preceeding study IC51-304
1088030|NCT00595270|E2|Reported Event|IC51 1 x 12 µg|treatment group in preceeding study IC51-304
1088031|NCT00595270|E1|Reported Event|IC51 2 x 6 µg|treatment group in preceeding study IC51-304
1088032|NCT00595153|B4|Baseline|Total|Total of all reporting groups
1088033|NCT00595153|B3|Baseline|Asthmatics on ICS Treatment|"Asthmatics, who are already on inhaled corticosteroids who will be put on standardized dose of inhaled corticosteroids~Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
1088034|NCT00595153|B2|Baseline|Steroid Naive Asthmatics|"Asthmatics not on inhaled corticosteroids who will be put on an inhaled steroid during the study~Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
1088035|NCT00595153|B1|Baseline|Healthy Control|Healthy, non-asthmatics who will not be put on any intervention
1088036|NCT00595153|P3|Participant Flow|Asthmatics on ICS Treatment|"Asthmatics, who are already on inhaled corticosteroids who will be put on standardized dose of inhaled corticosteroids~Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
1088037|NCT00595153|P2|Participant Flow|Steroid Naive Asthmatics|"Asthmatics not on inhaled corticosteroids who will be put on an inhaled steroid during the study~Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
1088038|NCT00595153|P1|Participant Flow|Healthy Control|Healthy, non-asthmatics who will not be put on any intervention
1088039|NCT00595153|O3|Outcome|Asthmatics on ICS Treatment|"Asthmatics, who are already on inhaled corticosteroids who will be put on standardized dose of inhaled corticosteroids~Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
1088040|NCT00595153|O2|Outcome|Steroid Naive Asthmatics|"Asthmatics not on inhaled corticosteroids who will be put on an inhaled steroid during the study~Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
1088303|NCT00594425|B4|Baseline|Total|Total of all reporting groups
1088087|NCT00594958|B3|Baseline|IC51 Group C|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
1088332|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1088042|NCT00595153|E3|Reported Event|Asthmatics on ICS Treatment|"Asthmatics, who are already on inhaled corticosteroids who will be put on standardized dose of inhaled corticosteroids~Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
1088043|NCT00595153|E2|Reported Event|Steroid Naive Asthmatics|"Asthmatics not on inhaled corticosteroids who will be put on an inhaled steroid during the study~Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
1088044|NCT00595153|E1|Reported Event|Healthy Control|Healthy, non-asthmatics who will not be put on any intervention
1088045|NCT00595127|B1|Baseline|Cyclophosphamide and Fludarabine|To evaluate a cytoreductive regimen using standard TBI & cyclophosphamide w/ addition of fludarabine, to prepare pts w/ Fanconi anemia for Tcell depleted, allogeneic hematopoietic stem cell transplant
1088046|NCT00595127|P1|Participant Flow|Cyclophosphamide and Fludarabine|To evaluate a cytoreductive regimen using standard TBI & cyclophosphamide w/ addition of fludarabine, to prepare pts w/ Fanconi anemia for Tcell depleted, allogeneic hematopoietic stem cell transplant
1088047|NCT00595127|O1|Outcome|Cyclophosphamide and Fludarabine|To evaluate a cytoreductive regimen using standard TBI & cyclophosphamide w/ addition of fludarabine, to prepare pts w/ Fanconi anemia for Tcell depleted, allogeneic hematopoietic stem cell transplant
1088048|NCT00595127|E1|Reported Event|Cyclophosphamide and Fludarabine|To evaluate a cytoreductive regimen using standard TBI & cyclophosphamide w/ addition of fludarabine, to prepare pts w/ Fanconi anemia for Tcell depleted, allogeneic hematopoietic stem cell transplant
1088049|NCT00595114|B3|Baseline|Total|Total of all reporting groups
1088050|NCT00595114|B2|Baseline|KIA 1|Participants from the KIA trial with severe asthma
1088051|NCT00595114|B1|Baseline|MIA 1|Participants from the MIA trial with mild asthma
1088052|NCT00595114|P2|Participant Flow|KIA 1|Participants from the KIA trial with severe asthma
1088053|NCT00595114|P1|Participant Flow|MIA 1|Participants from the MIA trial with mild asthma
1088054|NCT00595114|O2|Outcome|KIA 1|Participants from the KIA trial with severe asthma
1088055|NCT00595114|O1|Outcome|MIA 1|Participants from the MIA trial with mild asthma
1088056|NCT00595114|E2|Reported Event|KIA 1|Participants from the KIA trial with severe asthma
1088057|NCT00595114|E1|Reported Event|MIA 1|Participants from the MIA trial with mild asthma
1088058|NCT00595088|B1|Baseline|20 mg of BC-819/PEI|Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.
1088059|NCT00595088|P1|Participant Flow|20 mg of BC-819/PEI|Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.
1088060|NCT00595088|O1|Outcome|20 mg of BC-819/PEI|Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.
1088061|NCT00595088|O1|Outcome|20 mg of BC-819/PEI|Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.
1088062|NCT00595088|O1|Outcome|20 mg of BC-819/PEI|Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.
1088063|NCT00595088|O1|Outcome|20 mg of BC-819/PEI|Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.
1088064|NCT00595088|E1|Reported Event|20 mg of BC-819/PEI|Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.
1088065|NCT00595075|B3|Baseline|Total|Total of all reporting groups
1088066|NCT00595075|B2|Baseline|Placebo in First Crossover Period|Placebo will be given prior to a 2-hour nap
1088067|NCT00595075|B1|Baseline|Ramelteon in First Crossover Period|Ramelteon 8 mg will be given prior to a 2-hour nap
1088068|NCT00595075|P2|Participant Flow|Placebo in First Crossover Period|Placebo will be given prior to a 2-hour nap
1088069|NCT00595075|P1|Participant Flow|Ramelteon in First Crossover Period|Ramelteon 8 mg will be given prior to a 2-hour nap
1088070|NCT00595075|O2|Outcome|Placebo|Placebo will be given prior to a 2-hour nap
1088071|NCT00595075|O1|Outcome|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
1088072|NCT00595075|O2|Outcome|Placebo|Placebo will be given prior to a 2-hour nap
1088073|NCT00595075|O1|Outcome|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
1088074|NCT00595075|O2|Outcome|Placebo|Placebo will be given prior to a 2-hour nap
1088075|NCT00595075|O1|Outcome|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
1088076|NCT00595075|O2|Outcome|Placebo|Placebo will be given prior to a 2-hour nap
1088077|NCT00595075|O1|Outcome|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
1088078|NCT00595075|O2|Outcome|Placebo|Placebo will be given prior to a 2-hour nap
1088079|NCT00595075|O1|Outcome|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
1088080|NCT00595075|O2|Outcome|Placebo|Placebo will be given prior to a 2-hour nap
1088081|NCT00595075|O1|Outcome|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
1088082|NCT00595075|O2|Outcome|Placebo|Placebo will be given prior to a 2-hour nap
1088083|NCT00595075|O1|Outcome|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
1088084|NCT00595075|E2|Reported Event|Placebo|Placebo will be given prior to a 2-hour nap
1088088|NCT00594958|B2|Baseline|IC51 Group B|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
1088089|NCT00594958|B1|Baseline|IC51 Group A|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
1088090|NCT00594958|P3|Participant Flow|IC51 Group C|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
1088091|NCT00594958|P2|Participant Flow|IC51 Group B|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
1088092|NCT00594958|P1|Participant Flow|IC51 Group A|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
1088093|NCT00594958|O3|Outcome|IC51 Group C|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
1088094|NCT00594958|O2|Outcome|IC51 Group B|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
1088095|NCT00594958|O1|Outcome|IC51 Group A|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
1088096|NCT00594958|E3|Reported Event|IC51 Group C|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
1088097|NCT00594958|E2|Reported Event|IC51 Group B|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
1088098|NCT00594958|E1|Reported Event|IC51 Group A|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
1088099|NCT00594945|B4|Baseline|Total|Total of all reporting groups
1088100|NCT00594945|B3|Baseline|Intranasal Clonazepam Both Dose Groups 2 mg & 3 mg|
1088101|NCT00594945|B2|Baseline|Intranasal Clonazepam 3 mg|
1088102|NCT00594945|B1|Baseline|Intranasal Clonazepam 2 mg|
1088103|NCT00594945|P3|Participant Flow|Intranasal Clonazepam Both Dose Groups 2 mg & 3 mg|Subjects who were administered 2 mg during Cohort 1 and then 3 mg during Cohort 2
1088104|NCT00594945|P2|Participant Flow|Intranasal Clonazepam 3 mg|Treatment administered to subjects during Cohort 2
1088105|NCT00594945|P1|Participant Flow|Intranasal Clonazepam 2 mg|Treatment administered to subjects during Cohort 1
1088106|NCT00594945|O2|Outcome|Intranasal Clonazepam 3 mg|
1088107|NCT00594945|O1|Outcome|Intranasal Clonazepam 2 mg|
1088108|NCT00594945|E2|Reported Event|Intranasal Clonazepam 3 mg|
1088109|NCT00594945|E1|Reported Event|Intranasal Clonazepam 2 mg|
1088110|NCT00594906|B3|Baseline|Total|Total of all reporting groups
1088111|NCT00594906|B2|Baseline|Placebo|"30 participants will receive placebo injection pens.~Placebo : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)"
1088112|NCT00594906|B1|Baseline|Injection|"30 participants will receive teriparatide (Forteo) injection pens.~Teriparatide : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)"
1088113|NCT00594906|P2|Participant Flow|Placebo Injection|"30 participants will receive placebo injection pens.~Placebo : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)"
1088114|NCT00594906|P1|Participant Flow|Forteo Injection|"30 participants will receive teriparatide (Forteo) injection pens.~Teriparatide : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)"
1088115|NCT00594906|O2|Outcome|Forteo Patients|Patients who recieved Forteo Injections.
1088116|NCT00594906|O1|Outcome|Placebo Patients|Patients who recieved Placebo injections.
1088117|NCT00594906|E2|Reported Event|Placebo Injection|Patients who were randomized to Placebo
1088118|NCT00594906|E1|Reported Event|Forteo Injection|Patients who randomized to the study drug, Forteo
1088119|NCT00594880|B3|Baseline|Total|Total of all reporting groups
1088120|NCT00594880|B2|Baseline|Pegasys 90 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 90 mcg/week sc~Pegylated Interferon-alpha 2a, 90 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
1088121|NCT00594880|B1|Baseline|Pegasys 180 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 180 mcg/week sc~Pegylated Interferon-alpha 2a, 180 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
1088122|NCT00594880|P2|Participant Flow|Pegasys 90 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 90 mcg/week sc~Pegylated Interferon-alpha 2a, 90 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
1088123|NCT00594880|P1|Participant Flow|Pegasys 180 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 180 mcg/week sc~Pegylated Interferon-alpha 2a, 180 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
1088124|NCT00594880|O2|Outcome|90 mcg/Week|Arm 2 subjects with VL < 400 at week 12 of treatment who elected to continue study treatment for an additional 12 weeks
1088125|NCT00594880|O1|Outcome|180 mcg/Week|Arm 1 subjects with VL < 400 at week 12 of treatment who elected to continue study treatment for an additional 12 weeks
1088126|NCT00594880|O2|Outcome|90 mcg/Week|Patients receiving 90 micrograms/week of pegylated interferon alpha-2a
1088127|NCT00594880|O1|Outcome|180 mcg/Week|Patients receiving 180 micrograms/week of pegylated interferon alpha-2a
1088128|NCT00594880|O2|Outcome|Pegasys 90 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 90 mcg/week sc~Pegylated Interferon-alpha 2a, 90 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
1088304|NCT00594425|B3|Baseline|Vehicle PDT|
1088323|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1088324|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1088325|NCT00594425|O3|Outcome|Vehicle PDT|
1088129|NCT00594880|O1|Outcome|Pegasys 180 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 180 mcg/week sc~Pegylated Interferon-alpha 2a, 180 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
1088130|NCT00594880|E2|Reported Event|Pegasys 90 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 90 mcg/week sc~Pegylated Interferon-alpha 2a, 90 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
1088131|NCT00594880|E1|Reported Event|Pegasys 180 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 180 mcg/week sc~Pegylated Interferon-alpha 2a, 180 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
1088132|NCT00594854|B3|Baseline|Total|Total of all reporting groups
1088133|NCT00594854|B2|Baseline|Arthrotec|diclofenac/misoprostol dosed twice daily (bid)
1088134|NCT00594854|B1|Baseline|PN400 (VIMOVO)|PN 400 (esomeprazole/naproxen) dosed twice daily (bid)
1088135|NCT00594854|P2|Participant Flow|Arthrotec|diclofenac/misoprostol dosed twice daily (bid)
1088136|NCT00594854|P1|Participant Flow|PN400 (VIMOVO)|PN 400 (esomeprazole/naproxen) dosed twice daily (bid)
1088137|NCT00594854|O2|Outcome|Arthrotec|diclofenac/misoprostol dosed twice daily (bid)
1088138|NCT00594854|O1|Outcome|PN400 (VIMOVO)|PN 400 (esomeprazole/naproxen) dosed twice daily (bid)
1088139|NCT00594854|O2|Outcome|Arthrotec|diclofenac/misoprostol dosed twice daily (bid)
1088140|NCT00594854|O1|Outcome|PN400 (VIMOVO)|PN 400 (esomeprazole/naproxen) dosed twice daily (bid)
1088141|NCT00594854|O2|Outcome|Arthrotec|diclofenac/misoprostol dosed twice daily (bid)
1088142|NCT00594854|O1|Outcome|PN400 (VIMOVO)|PN 400 (esomeprazole/naproxen) dosed twice daily (bid)
1088143|NCT00594854|E2|Reported Event|Arthrotec|diclofenac/misoprostol dosed twice daily (bid)
1088144|NCT00594854|E1|Reported Event|PN400 (VIMOVO)|PN 400 (esomeprazole/naproxen) dosed twice daily (bid)
1088145|NCT00594815|B1|Baseline|Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma|Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine: Immunochemotherapy
1088146|NCT00594815|P1|Participant Flow|Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma|Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine: Immunochemotherapy
1088147|NCT00594815|O1|Outcome|Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma|Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine: Immunochemotherapy
1088148|NCT00594815|O1|Outcome|Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma|Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine: Immunochemotherapy
1088149|NCT00594815|E1|Reported Event|Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma|This is a single-armed pilot study designed to evaluate the safety and efficacy of combined immunochemotherapy followed by reduced dose radiation for participants with newly diagnosed PCNSL.
1088150|NCT00594685|B1|Baseline|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
1088151|NCT00594685|P1|Participant Flow|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
1088152|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
1088153|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
1088154|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
1088155|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
1088156|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
1088157|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
1088158|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
1088159|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
1088160|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
1088161|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
1088162|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
1088163|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
1088164|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
1088165|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
1088166|NCT00594685|E1|Reported Event|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
1088167|NCT00594659|B4|Baseline|Total|Total of all reporting groups
1088168|NCT00594659|B3|Baseline|3-tMET|"Therapist delivered motivational enhancement therapy (tMET)~Two session treatment with sessions delivered during weeks 1 and 4.~Two times per week urine drug testing.~Non-contingent incentives delivered for attending each urine testing appointment."
1088169|NCT00594659|B2|Baseline|2-cMET/CBT/CM|"Computer-delievered (c) MET/CBT/CM treatment~Computer delivered nine MET/CBT sessions during weeks 1-8 and week 12. therapist delivered 3 brief supportive counseling sessions during weeks 1, 4, and 12.~2 times per week urine drug testing.~Contingency management program delivered monetary-based incentives contingent on each marijuana-negative urine toxicology test."
1088170|NCT00594659|B1|Baseline|1-MET/CBT/CM|"Therapist delivered motivational enhancement therapy plus cognitive behavioral therapy plus contingency management (tMET/CBT/CM)~Nine weekly therapy sessions delivered in weeks 1-8 and week 12~2 times per week urine drug testing~Contingency management program delivered monetary-based incentives contingent on each marijuana-negative urine toxicology test."
1088171|NCT00594659|P3|Participant Flow|3-tMET|"Motivational enhancement therapy~Motivational enhancement therapy : Two session treatment~2x/wk urine drug testing~non-contingent vouchers"
1088172|NCT00594659|P2|Participant Flow|2-cMET/CBT/CM|"Computer-delievered (c) MET/CBT/CM treatment~Computerized Psychotherapy : Nine session computer delivered treatment~2 times per week urine drug testing"
1088173|NCT00594659|P1|Participant Flow|1-MET/CBT/CM|"Therapist delivered motivational enhancement therapy plus cognitive behavioral therapy plus contingency management (tMET/CBT/CM)~Psychotherapy : Nine session treatment (wks 1-8 and wk 12)~2x/wk urine drug testing~Contingency Management voucher program"
1088174|NCT00594659|O3|Outcome|3-tMET|"Motivational enhancement therapy~Motivational enhancement therapy : Two session treatment"
1088175|NCT00594659|O2|Outcome|2-cMET/CBT/CM|"Computerized Cognitive Behavioral treatment~Computerized Psychotherapy : Nine session computer delivered treatment"
1088176|NCT00594659|O1|Outcome|1-tMET/CBT/CM|"Therapist delivered cognitive behavioral treatment~Psychotherapy : Nine session treatment"
1088177|NCT00594659|O3|Outcome|3-tMET|"Motivational enhancement therapy~Motivational enhancement therapy : Two session treatment"
1088178|NCT00594659|O2|Outcome|2-cMET/CBT/CM|"Computerized Cognitive Behavioral treatment~Computerized Psychotherapy : Nine session computer delivered treatment"
1088179|NCT00594659|O1|Outcome|1-tMET/CBT/CM|"Therapist delivered cognitive behavioral treatment~Psychotherapy : Nine session treatment"
1088180|NCT00594659|E3|Reported Event|3-tMET|"Motivational enhancement therapy~Motivational enhancement therapy : Two session treatment~2x/wk urine drug testing~non-contingent vouchers"
1088181|NCT00594659|E2|Reported Event|2-cMET/CBT/CM|"Computer-delievered (c) MET/CBT/CM treatment~Computerized Psychotherapy : Nine session computer delivered treatment~2 times per week urine drug testing"
1088182|NCT00594659|E1|Reported Event|1-MET/CBT/CM|"Therapist delivered motivational enhancement therapy plus cognitive behavioral therapy plus contingency management (tMET/CBT/CM)~Psychotherapy : Nine session treatment (wks 1-8 and wk 12)~2x/wk urine drug testing~Contingency Management voucher program"
1088183|NCT00594646|B1|Baseline|Group 1|TRUVADA (tenofovir DF 300mg + emtricitabine 200mg) + raltegravir (400mg)
1088184|NCT00594646|P1|Participant Flow|Group 1|Men or women, 18 years of age or older, who present within 72 hours of a potential non-occupational exposure to HIV-1.
1088185|NCT00594646|O1|Outcome|Group 1|TRUVADA (tenofovir DF 300mg + emtricitabine 200mg) + raltegravir (400mg)
1088186|NCT00594646|O1|Outcome|Group 1|TDF 300mg + FTC 200mg (TDF/FTC) once daily + raltegravir 400mg twice daily
1088187|NCT00594646|E1|Reported Event|Group 1|TDF 300mg and FTC 200mg (TDF/FTC) once daily + raltegravir (400mg) twice daily
1088188|NCT00594568|B4|Baseline|Total|Total of all reporting groups
1088189|NCT00594568|B3|Baseline|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1088190|NCT00594568|B2|Baseline|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
1088191|NCT00594568|B1|Baseline|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
1088192|NCT00594568|P3|Participant Flow|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1088193|NCT00594568|P2|Participant Flow|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
1088194|NCT00594568|P1|Participant Flow|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
1088195|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1088196|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
1088197|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
1088198|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1172355|NCT00381303|O5|Outcome|Hispanic|
1088199|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
1088200|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
1088201|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1088202|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
1088203|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
1088204|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1088205|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
1088206|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
1088207|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1088208|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
1088209|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
1088210|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1088211|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
1088212|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
1088213|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1088214|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
1088215|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
1088216|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1088217|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
1088218|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
1088219|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1088220|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
1088221|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
1088222|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1088223|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
1088224|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
1088225|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1088226|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
1088227|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
1088228|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1088229|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
1088230|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
1088231|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1088305|NCT00594425|B2|Baseline|80 mg/g MAL PDT|
1088232|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
1088233|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
1088234|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1088235|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
1088236|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
1088237|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1088238|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
1088239|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
1088240|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1088241|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
1088242|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
1088243|NCT00594568|O1|Outcome|LY450139|Participants received 60 milligram LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1088244|NCT00594568|O1|Outcome|LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1088245|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1088246|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
1088247|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
1088248|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1088249|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
1088250|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
1088251|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1088252|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
1088253|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
1088254|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1088255|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
1088256|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
1088257|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1088258|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
1088259|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
1088260|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1088261|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
1088262|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
1088263|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1088264|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
1088306|NCT00594425|B1|Baseline|40 mg/g MAL PDT|
1088265|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
1088266|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1088267|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
1088268|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
1088269|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1088270|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
1088271|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
1088272|NCT00594568|E9|Reported Event|140 mg LY450139- SFU|For SFU, study drug had been stopped and period was optional to enter; Participants entered from 140 mg LY450139 initial treatment or delayed start or did not enter SFU.
1088273|NCT00594568|E8|Reported Event|100 mg LY450139- SFU|For SFU, study drug had been stopped and period was optional to enter; Participants entered from 100 mg LY450139 initial treatment or delayed start or did not enter SFU.
1088274|NCT00594568|E7|Reported Event|Placebo- Safety FU Period (SFU)|For SFU, study drug had been stopped and period was optional to enter; Participants entered from Placebo initial treatment or delayed start or did not enter SFU.
1088275|NCT00594568|E6|Reported Event|140 mg LY450139 - DO|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1088276|NCT00594568|E5|Reported Event|100 mg LY450139 - DO|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by gradual escalation to 100 mg LY450139 orally once daily until Week 88.
1088277|NCT00594568|E4|Reported Event|Placebo - Delayed Start Period (DO)|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
1088278|NCT00594568|E3|Reported Event|140 mg LY450139 - NT|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
1088279|NCT00594568|E2|Reported Event|100 mg LY450139 - NT|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by gradual escalation to 100 mg LY450139 orally once daily until Week 88.
1088280|NCT00594568|E1|Reported Event|Placebo - Initial Treatment Period (NT)|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 milligrams (mg) orally once daily until Week 88.
1088281|NCT00594516|B1|Baseline|Tapentadol|Subjects treated in the Tapentadol(CG5503) Immediate Release (IR) Open-Label period
1088282|NCT00594516|P3|Participant Flow|Tapentadol ER to IR|Tapentadol ER in first intervention period of double-blind phase and Tapentadol IR in second intervention period of double-blind phase
1088283|NCT00594516|P2|Participant Flow|Tapentadol IR to ER|Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER in second intervention period of double-blind phase
1088284|NCT00594516|P1|Participant Flow|Tapentadol|Subjects treated in the Tapentadol(CG5503) Immediate Release (IR) Open-Label period
1088285|NCT00594516|O1|Outcome|Tapentadol|Subjects treated in the Tapentadol Immediate Release (IR) Open-Label period (followed by randomization to double-blind crossover maintenance period in which all subjects receive both IR and ER formulations)
1088286|NCT00594516|O1|Outcome|Tapentadol|Subjects treated in the Tapentadol Immediate Release (IR) Open-Label period (followed by randomization to double-blind crossover maintenance period in which all subjects receive both IR and ER formulations)
1088287|NCT00594516|O1|Outcome|Tapentadol|Subjects treated in the Tapentadol Immediate Release (IR) Open-Label period (followed by randomization to double-blind crossover maintenance period in which all subjects receive both IR and ER formulations)
1088288|NCT00594516|O1|Outcome|Tapentadol|Subjects treated in the Tapentadol Immediate Release (IR) Open-Label period (followed by randomization to double-blind crossover maintenance period in which all subjects receive both IR and ER formulations)
1088289|NCT00594516|O1|Outcome|Tapentadol|Subjects treated in the Tapentadol Immediate Release (IR) Open-Label period (followed by randomization to double-blind crossover maintenance period in which all subjects receive both IR and ER formulations)
1088290|NCT00594516|E1|Reported Event|Tapentadol|Subjects treated in the Tapentadol Immediate Release (IR) open-label and the double-blind crossover period.
1088291|NCT00594464|B1|Baseline|Rotigotine|Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
1088292|NCT00594464|P1|Participant Flow|Rotigotine|Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
1088293|NCT00594464|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
1088294|NCT00594464|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
1088295|NCT00594464|O6|Outcome|Rotigotine 16 mg/24h|
1088296|NCT00594464|O5|Outcome|Rotigotine 14 mg/24h|
1088297|NCT00594464|O4|Outcome|Rotigotine 12 mg/24h|
1088298|NCT00594464|O3|Outcome|Rotigotine 8 mg/24h|
1088299|NCT00594464|O2|Outcome|Rotigotine 6mg/24h|
1088300|NCT00594464|O1|Outcome|Rotigotine 2 mg/24h|
1088301|NCT00594464|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
1088302|NCT00594464|E1|Reported Event|Rotigotine|Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
1088333|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1088334|NCT00594425|O3|Outcome|Vehicle PDT|
1088335|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1088336|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1088337|NCT00594425|O3|Outcome|Vehicle PDT|
1088338|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1088339|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1088340|NCT00594425|O3|Outcome|Vehicle PDT|
1088341|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1088342|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1088343|NCT00594425|O3|Outcome|Vehicle PDT|
1088344|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1088345|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1088346|NCT00594425|O3|Outcome|Vehicle PDT|
1088347|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1088348|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1088349|NCT00594425|O3|Outcome|Vehicle PDT|
1088350|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1088351|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1088352|NCT00594425|O3|Outcome|Vehicle PDT|
1088353|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1088354|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1088355|NCT00594425|O3|Outcome|Vehicle PDT|
1088356|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1088357|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1088358|NCT00594425|O3|Outcome|Vehicle PDT|
1088359|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1088360|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1088361|NCT00594425|O3|Outcome|Vehicle PDT|
1088362|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1088363|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1088364|NCT00594425|O3|Outcome|Vehicle PDT|
1088365|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1088366|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1088367|NCT00594425|O3|Outcome|Vehicle PDT|
1088368|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1088369|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1088370|NCT00594425|O3|Outcome|Vehicle PDT|
1088371|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1088372|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1088373|NCT00594425|O3|Outcome|Vehicle PDT|
1088374|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1088375|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1088376|NCT00594425|O3|Outcome|Vehicle PDT|
1088377|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1088378|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1088379|NCT00594425|O3|Outcome|Vehicle PDT|
1088380|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1088381|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1088382|NCT00594425|O3|Outcome|Vehicle PDT|
1088383|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1088384|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1088385|NCT00594425|O3|Outcome|Vehicle PDT|
1088386|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1088387|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1088388|NCT00594425|O3|Outcome|Vehicle PDT|
1088389|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1088390|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1088391|NCT00594425|O3|Outcome|Vehicle PDT|
1088392|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1088393|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1088394|NCT00594425|O3|Outcome|Vehicle PDT|
1088395|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1088396|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1088397|NCT00594425|O3|Outcome|Vehicle PDT|
1088398|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1088399|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1088400|NCT00594425|O3|Outcome|Vehicle PDT|
1088401|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1088402|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1088403|NCT00594425|O3|Outcome|Vehicle PDT|
1088404|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1088405|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1088406|NCT00594425|O3|Outcome|Vehicle PDT|
1088407|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1088408|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1088409|NCT00594425|O3|Outcome|Vehicle PDT|
1088410|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1088411|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1088412|NCT00594425|O3|Outcome|Vehicle PDT|
1088413|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
1088414|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
1088415|NCT00594425|E3|Reported Event|Vehicle PDT|
1088416|NCT00594425|E2|Reported Event|80 mg/g MAL PDT|
1088417|NCT00594425|E1|Reported Event|40 mg/g MAL PDT|
1088418|NCT00594399|B3|Baseline|Total|Total of all reporting groups
1088419|NCT00594399|B2|Baseline|Arm 2|Usual care from primary, womens or geriatric clinics
1088420|NCT00594399|B1|Baseline|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
1093127|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
1088421|NCT00594399|P3|Participant Flow|Arm 3, Physical Activity Counseling, Reduced Dose|Upon rerandomization, individuals in this group continued to receive monthly physical activity counseling through 6 months which was then reduced to every other month during months 6-12.
1088422|NCT00594399|P2|Participant Flow|Arm 2, Usual Care|Usual care from primary, womens or geriatric clinics
1088610|NCT00593827|E2|Reported Event|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
1088611|NCT00593827|E1|Reported Event|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
1088423|NCT00594399|P1|Participant Flow|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
1088424|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
1088425|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
1088426|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
1088427|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
1088428|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
1088429|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
1088430|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
1088431|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
1088432|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
1088433|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
1088434|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
1088435|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
1088436|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
1088437|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
1088438|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
1088612|NCT00593814|B3|Baseline|Total|Total of all reporting groups
1088613|NCT00593814|B2|Baseline|Original EXCLUDER|Historical Sample from original study of EXCLUDER Device. The original EXCLUDER Device was designed for the endovascular treatment of abdominal aortic aneurysms.
1089210|NCT00592839|O3|Outcome|Placebo Daily|Placebo tablet daily orally
1088439|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
1088440|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
1088441|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
1088442|NCT00594399|E2|Reported Event|Arm 2|Usual care from primary, womens or geriatric clinics
1088443|NCT00594399|E1|Reported Event|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
1088444|NCT00594386|B1|Baseline|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
1088445|NCT00594386|P1|Participant Flow|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
1088446|NCT00594386|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
1088447|NCT00594386|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
1088448|NCT00594386|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
1088449|NCT00594386|E1|Reported Event|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
1088450|NCT00594308|B1|Baseline|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
1088451|NCT00594308|P1|Participant Flow|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
1088452|NCT00594308|O1|Outcome|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
1088453|NCT00594308|O1|Outcome|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
1088454|NCT00594308|O1|Outcome|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
1088455|NCT00594308|O1|Outcome|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
1088456|NCT00594308|O1|Outcome|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
1088457|NCT00594308|E1|Reported Event|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
1088458|NCT00594256|B1|Baseline|Sodium Oxybate (Open Label)|open label sodium oxybate treatment, beginning at 4.5 g/night and increasing weekly to a final dose of 9 g/night. Given in divided dose, half at bedtime and half 4 hours later (subjects were woken up)
1088459|NCT00594256|P1|Participant Flow|Sodium Oxybate (Open Label)|open label sodium oxybate treatment, beginning at 4.5 g/night and increasing weekly to a final dose of 9 g/night. Given in divided dose, half at bedtime and half 4 hours later (subjects were woken up)
1088460|NCT00594256|O1|Outcome|Sodium Oxybate|
1088461|NCT00594256|O1|Outcome|Sodium Oxybate|
1088462|NCT00594256|O1|Outcome|Sodiumn Oxybate|
1088463|NCT00594256|O1|Outcome|Sodium Oxybate|
1088464|NCT00594256|O1|Outcome|Sodium Oxybate|
1088465|NCT00594256|E1|Reported Event|Sodium Oxybate (Open Label)|open label sodium oxybate treatment, beginning at 4.5 g/night and increasing weekly to a final dose of 9 g/night. Given in divided dose, half at bedtime and half 4 hours later (subjects were woken up)
1088466|NCT00594230|B3|Baseline|Total|Total of all reporting groups
1088467|NCT00594230|B2|Baseline|Panobinostat 20 mg|Panobinostat(20 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
1088515|NCT00594035|E2|Reported Event|Standard of Care|Subjects who receive standard or care meathods of dural sealing
1088516|NCT00594035|E1|Reported Event|Spinal Sealant|Subjects that recieve DuraSeal Spinal Sealant
1088517|NCT00594022|B3|Baseline|Total|Total of all reporting groups
1088609|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
1172356|NCT00381303|O4|Outcome|Caucasian|
1088468|NCT00594230|B1|Baseline|Panobinostat 30 mg|Panobinostat(30 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
1088469|NCT00594230|P2|Participant Flow|Panobinostat 20 mg|Panobinostat(20 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
1088470|NCT00594230|P1|Participant Flow|Panobinostat 30 mg|Panobinostat(30 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
1088471|NCT00594230|O2|Outcome|Panobinostat 20 mg|Panobinostat(20 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
1088472|NCT00594230|O1|Outcome|Panobinostat 30 mg|Panobinostat(30 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
1088473|NCT00594230|E2|Reported Event|Panobinostat 30 mg|Panobinostat(30 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
1088474|NCT00594230|E1|Reported Event|Panobinostat 20 mg|Panobinostat(20 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
1088475|NCT00594204|B3|Baseline|Total|Total of all reporting groups
1088476|NCT00594204|B2|Baseline|Placebo|matching placebo following the same treatment schema as the varenicline group
1088477|NCT00594204|B1|Baseline|Varenicline|0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
1088478|NCT00594204|P2|Participant Flow|Placebo|matching placebo following the same treatment schema as the varenicline group
1088479|NCT00594204|P1|Participant Flow|Varenicline|0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
1088480|NCT00594204|O2|Outcome|Placebo|matching placebo following the same treatment schema as the varenicline group
1088481|NCT00594204|O1|Outcome|Varenicline|0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
1088482|NCT00594204|O2|Outcome|Placebo|matching placebo following the same treatment schema as the varenicline group
1088483|NCT00594204|O1|Outcome|Varenicline|0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
1088484|NCT00594204|O2|Outcome|Placebo|matching placebo following the same treatment schema as the varenicline group
1088485|NCT00594204|O1|Outcome|Varenicline|0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
1088486|NCT00594204|E2|Reported Event|Placebo|matching placebo following the same treatment schema as the varenicline group
1088487|NCT00594204|E1|Reported Event|Varenicline|0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
1088488|NCT00594178|B1|Baseline|Passive Exercise With Motorized Bicycle|The exercise was conducted from the subjects wheelchair with the feet attached to the bicycle by velcro straps and extra ankle dorsiflexion, provided by wedges on the pedal, to stretch the gastrocnemeus and soleus muscles. 60 minutes of exercise at with a goal of 60 rpm per training session. The exercise was conducted three times a week for 16 weeks or 5 times a week for 12 weeks, for an average of 50 sessions. Each subjects bone density and lean muscle mass was measured by DEXA scan, using a low radiation dose to determine the effect of exercise by comparing the subjects change in both parameters before the exercise and then after the exercise.
1088529|NCT00594022|O1|Outcome|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).~Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
1088489|NCT00594178|P1|Participant Flow|Passive Exercise With Motorized Bicycle|The exercise was conducted from the subjects wheelchair with the feet attached to the bicycle by velcro straps and extra ankle dorsiflexion, provided by wedges on the pedal, to stretch the gastrocnemeus and soleus muscles. 60 minutes of exercise at with a goal of 60 rpm per training session. The exercise was conducted three times a week for 16 weeks or 5 times a week for 12 weeks, for an average of 50 sessions. Each subjects bone density and lean muscle mass was measured by DEXA scan, using a low radiation dose to determine the effect of exercise by comparing the subjects change in both parameters before the exercise and then after the exercise.
1088490|NCT00594178|O1|Outcome|Passive Exercise With Motorized Bicycle|The exercise was conducted from the subjects wheelchair with the feet attached to the bicycle by velcro straps and extra ankle dorsiflexion, provided by wedges on the pedal, to stretch the gastrocnemeus and soleus muscles. 60 minutes of exercise at with a goal of 60 rpm per training session. The exercise was conducted three times a week for 16 weeks or 5 times a week for 12 weeks, for an average of 50 sessions. Each subjects bone density and lean muscle mass was measured by DEXA scan, using a low radiation dose to determine the effect of exercise by comparing the subjects change in both parameters before the exercise and then after the exercise.
1088491|NCT00594178|O1|Outcome|Passive Exercise With Motorized Bicycle|The exercise was conducted from the subjects wheelchair with the feet attached to the bicycle by velcro straps and extra ankle dorsiflexion, provided by wedges on the pedal, to stretch the gastrocnemeus and soleus muscles. 60 minutes of exercise at with a goal of 60 rpm per training session. The exercise was conducted three times a week for 16 weeks or 5 times a week for 12 weeks, for an average of 50 sessions. Each subjects bone density and lean muscle mass was measured by DEXA scan, using a low radiation dose to determine the effect of exercise by comparing the subjects change in both parameters before the exercise and then after the exercise.
1088492|NCT00594178|E1|Reported Event|Passive Exercise With Motorized Bicycle|The exercise was conducted from the subjects wheelchair with the feet attached to the bicycle by velcro straps and extra ankle dorsiflexion, provided by wedges on the pedal, to stretch the gastrocnemeus and soleus muscles. 60 minutes of exercise at with a goal of 60 rpm per training session. The exercise was conducted three times a week for 16 weeks or 5 times a week for 12 weeks, for an average of 50 sessions. Each subjects bone density and lean muscle mass was measured by DEXA scan, using a low radiation dose to determine the effect of exercise by comparing the subjects change in both parameters before the exercise and then after the exercise.
1088493|NCT00594165|B1|Baseline|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
1088494|NCT00594165|P1|Participant Flow|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
1088495|NCT00594165|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
1088496|NCT00594165|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
1088497|NCT00594165|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
1088498|NCT00594165|E1|Reported Event|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
1088499|NCT00594100|B1|Baseline|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
1088500|NCT00594100|P1|Participant Flow|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
1088501|NCT00594100|O1|Outcome|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
1088502|NCT00594100|O1|Outcome|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
1088503|NCT00594100|O1|Outcome|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
1088504|NCT00594100|O1|Outcome|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
1088505|NCT00594100|O1|Outcome|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
1088506|NCT00594100|O1|Outcome|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
1088507|NCT00594100|E1|Reported Event|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
1088508|NCT00594035|B3|Baseline|Total|Total of all reporting groups
1088509|NCT00594035|B2|Baseline|Standard of Care|Subjects who receive standard or care meathods of dural sealing
1088510|NCT00594035|B1|Baseline|Spinal Sealant|Subjects that recieve DuraSeal Spinal Sealant
1088511|NCT00594035|P2|Participant Flow|Standard of Care|Subjects who receive standard or care meathods of dural sealing
1088512|NCT00594035|P1|Participant Flow|Spinal Sealant|Subjects that recieve DuraSeal Spinal Sealant
1088513|NCT00594035|O2|Outcome|Standard of Care|Subjects who receive standard or care meathods of dural sealing
1088514|NCT00594035|O1|Outcome|Spinal Sealant|Subjects that recieve DuraSeal Spinal Sealant
1088518|NCT00594022|B2|Baseline|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).~Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
1088519|NCT00594022|B1|Baseline|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT (multiple sleep latency test) >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).~Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
1088520|NCT00594022|P2|Participant Flow|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).~Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
1088521|NCT00594022|P1|Participant Flow|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).~Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
1088522|NCT00594022|O2|Outcome|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).~Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
1088523|NCT00594022|O1|Outcome|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).~Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
1088524|NCT00594022|O2|Outcome|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).~Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
1088525|NCT00594022|O1|Outcome|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).~Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
1088526|NCT00594022|O2|Outcome|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).~Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
1088527|NCT00594022|O1|Outcome|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).~Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
1088528|NCT00594022|O2|Outcome|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).~Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
1088602|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
1088603|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
1088604|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
1088530|NCT00594022|O2|Outcome|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).~Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
1088531|NCT00594022|O1|Outcome|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).~Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
1088532|NCT00594022|E2|Reported Event|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).~Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
1088533|NCT00594022|E1|Reported Event|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).~Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
1088534|NCT00593957|B4|Baseline|Total|Total of all reporting groups
1088535|NCT00593957|B3|Baseline|DM3 (5mg/kg/Day)|"Dextromethorphan 5mg/kg/day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
1088536|NCT00593957|B2|Baseline|DM2 (2.5 mg/kg/Day)|"Dextromethorphan 2.5 mg/kg/day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
1088537|NCT00593957|B1|Baseline|DM1( 0.25 mg/kg /Day)|"Dextromethorphan 0.25 mg/kg per day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
1088538|NCT00593957|P3|Participant Flow|DM3 (5mg/kg/Day)|"Dextromethorphan 5mg/kg/day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
1088539|NCT00593957|P2|Participant Flow|DM2 (2.5 mg/kg/Day)|"Dextromethorphan 2.5 mg/kg/day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
1088540|NCT00593957|P1|Participant Flow|DM1( 0.25 mg/kg /Day)|"Dextromethorphan 0.25 mg/kg per day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
1088541|NCT00593957|O2|Outcome|Total Sample SSI Mean Score at 6 Months|Study Sample Screen for Social Interaction (SSI) mean score at 6 months post-treatment.
1088542|NCT00593957|O1|Outcome|Total Sample SSI Mean Score at Baseline|Study Sample Screen for Social Interaction (SSI) mean core at baseline.
1088543|NCT00593957|O6|Outcome|DM3 (5.0 mg/kg/Day) SSI 6 Months|DM3(5.0) mg/kg /day)treatment arm Screen for Social Interaction (SSI) mean score at 6 months post-treatment.
1088544|NCT00593957|O5|Outcome|DM2 (2.5 mg/kg/Day) SSI 6 Months|DM2( 2.5 mg/kg /day)treatment arm Screen for Social Interaction (SSI) mean score at 6 months post-treatment.
1088545|NCT00593957|O4|Outcome|DM1( 0.25 mg/kg /Day) SSI 6 Months|DM1( 0.25 mg/kg /day)treatment arm Screen for Social Interaction (SSI) mean score at 6 months post-treatment.
1088546|NCT00593957|O3|Outcome|DM3 (5mg/kg/Day) SSI Baseline|Screen for Social Interaction (SSI) mean score at baseline for Dextromethorphan 5mg/kg/day treatment arm.
1088547|NCT00593957|O2|Outcome|DM2 (2.5 mg/kg/Day)SSI Baseline|Screen for Social Interaction (SSI) mean score at baseline for Dextromethorphan 2.5 mg/kg/day treatment arm.
1088548|NCT00593957|O1|Outcome|DM1( 0.25 mg/kg /Day) SSI Baseline|Screen for Social Interaction (SSI) mean score at baseline for Dextromethorphan 0.25 mg/kg per day treatment arm.
1088605|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
1172357|NCT00381303|O3|Outcome|Black|
1088549|NCT00593957|O3|Outcome|DM3 (5mg/kg/Day)|"Dextromethorphan 5mg/kg/day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
1088550|NCT00593957|O2|Outcome|DM2 (2.5 mg/kg/Day)|"Dextromethorphan 2.5 mg/kg/day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
1088551|NCT00593957|O1|Outcome|DM1( 0.25 mg/kg /Day)|"Dextromethorphan 0.25 mg/kg per day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
1088552|NCT00593957|O6|Outcome|DM3 EEG Spike Counts at 6 Months|DM3 group received Dextromethorphan 5mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months. EEG spike counts at 6 months.
1088553|NCT00593957|O5|Outcome|DM2 EEG Spike Counts at 6 Months|DM2 group participants received Dextromethorphan 2.5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months. DM2 EEG spike counts at 6 months.
1088554|NCT00593957|O4|Outcome|DM1 EEG Spike Count at 6 Months|DM1 group received Dextromethorphan 0.25 mg/kg per day. The drug is given in two divided doses 12 hours apart for 6 months. EEG spike count for DM1 group measured at 6 months.
1088555|NCT00593957|O3|Outcome|DM3 EEG Spike Counts at Baseline|"DM3 group received Dextromethorphan 5mg/kg/day.~The drug is given in two divided doses 12 hours apart for 6 months. EEG spike counts at baseline."
1088556|NCT00593957|O2|Outcome|DM2 EEG Spike Counts at Baseline|DM2 group participants received Dextromethorphan 2.5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months. DM2 EEG spike counts at baseline.
1088557|NCT00593957|O1|Outcome|Dextromethorphan (DM)1 EEG Spike Counts at Baseline|Dextromethorphan(DM)I group received Dextromethorphan 0.25 mg/kg per day. The drug is given in two divided doses 12 hours apart for 6 months. EEG spike count for DM1 group measured at baseline.
1088558|NCT00593957|E3|Reported Event|DM3 (5mg/kg/Day)|"Dextromethorphan 5mg/kg/day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
1088559|NCT00593957|E2|Reported Event|DM2 (2.5 mg/kg/Day)|"Dextromethorphan 2.5 mg/kg/day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
1088560|NCT00593957|E1|Reported Event|DM1( 0.25 mg/kg /Day)|"Dextromethorphan 0.25 mg/kg per day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
1088561|NCT00593918|B3|Baseline|Total|Total of all reporting groups
1088562|NCT00593918|B2|Baseline|Toll-like Receptor 4 AG/AA Genotypes|Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection
1088563|NCT00593918|B1|Baseline|Toll-like Receptor 4 GG Genotype|Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection
1088564|NCT00593918|P2|Participant Flow|Toll-like Receptor 4 AG/AA Genotypes|Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection
1088565|NCT00593918|P1|Participant Flow|Toll-like Receptor 4 GG Genotype|Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection
1088566|NCT00593918|O2|Outcome|Toll-like Receptor 4 AG/AA Genotypes|Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection
1088567|NCT00593918|O1|Outcome|Toll-like Receptor 4 GG Genotype|Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection
1088568|NCT00593918|O2|Outcome|Toll-like Receptor 4 AG/AA Genotypes|Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection
1088569|NCT00593918|O1|Outcome|Toll-like Receptor 4 GG Genotype|Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection
1088570|NCT00593918|E2|Reported Event|Toll-like Receptor 4 AG/AA Genotypes|Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection
1088571|NCT00593918|E1|Reported Event|Toll-like Receptor 4 GG Genotype|Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection
1088606|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
1088607|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
1088608|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
1088572|NCT00593866|B1|Baseline|Radiation Dose Escalation With Gemcitabine|"INTENSITY MODULATED RADIOTHERAPY~Radiation dose escalation:~Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4~BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level~Gemcitabine:~1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment"
1088573|NCT00593866|P1|Participant Flow|Radiation Dose Escalation With Gemcitabine|"INTENSITY MODULATED RADIOTHERAPY~Radiation dose escalation:~Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4~BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level~Gemcitabine:~1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment"
1088574|NCT00593866|O1|Outcome|Radiation Dose Escalation With Gemcitabine|"INTENSITY MODULATED RADIOTHERAPY~Radiation dose escalation:~Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4~BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level~Gemcitabine:~1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment"
1088575|NCT00593866|O1|Outcome|Radiation Dose Escalation With Gemcitabine|"INTENSITY MODULATED RADIOTHERAPY~Radiation dose escalation:~Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4~BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level~Gemcitabine:~1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment"
1088576|NCT00593866|E1|Reported Event|Radiation Dose Escalation With Gemcitabine|"INTENSITY MODULATED RADIOTHERAPY~Radiation dose escalation:~Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4~BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level~Gemcitabine:~1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment"
1088577|NCT00593840|B1|Baseline|Arm 1: Intensity Modulated Radiation Therapy (IMRT)|-This study provides guidelines for volume to be contoured during IMRT based on tumor site and stage of tumor site. The clinical tumor volume (CTV)1 will be treated to 66 Cy in 33 fractions or 60 Gy in 30 fractions. The CTV2 will be treated to 54 Gy in 33 fractions or 52 Gy in 30 fractions. The CTV3 will be modified based on tumor site and stage of tumor site in order to reduce volume.
1088578|NCT00593840|P1|Participant Flow|Arm 1: Intensity Modulated Radiation Therapy (IMRT)|-This study provides guidelines for volume to be contoured during IMRT based on tumor site and stage of tumor site. The clinical tumor volume (CTV)1 will be treated to 66 Cy in 33 fractions or 60 Gy in 30 fractions. The CTV2 will be treated to 54 Gy in 33 fractions or 52 Gy in 30 fractions. The CTV3 will be modified based on tumor site and stage of tumor site in order to reduce volume.
1088579|NCT00593840|O1|Outcome|Arm 1: IMRT|"CTV1 = 66 Gy in 33 fractions~CTV2 = 60 Gy in 33 fractions~CTV3 = 56 Gy in 33 fractions~CTV3 Proto = 56 Gy in 33 fractions"
1088580|NCT00593840|O1|Outcome|Arm 1: IMRT|"CTV1 = 66 Gy in 33 fractions~CTV2 = 60 Gy in 33 fractions~CTV3 = 56 Gy in 33 fractions~CTV3 Proto = 56 Gy in 33 fractions"
1088581|NCT00593840|O1|Outcome|Arm 1: IMRT|"CTV1 = 66 Gy in 33 fractions~CTV2 = 60 Gy in 33 fractions~CTV3 = 56 Gy in 33 fractions~CTV3 Proto = 56 Gy in 33 fractions"
1088582|NCT00593840|O1|Outcome|Arm 1: IMRT|"CTV1 = 66 Gy in 33 fractions~CTV2 = 60 Gy in 33 fractions~CTV3 = 56 Gy in 33 fractions~CTV3 Proto = 56 Gy in 33 fractions"
1088583|NCT00593840|O1|Outcome|Arm 1: IMRT|"CTV1 = 66 Gy in 33 fractions~CTV2 = 60 Gy in 33 fractions~CTV3 = 56 Gy in 33 fractions~CTV3 Proto = 56 Gy in 33 fractions"
1088584|NCT00593840|O1|Outcome|Arm 1: IMRT|"CTV1 = 66 Gy in 33 fractions~CTV2 = 60 Gy in 33 fractions~CTV3 = 56 Gy in 33 fractions~CTV3 Proto = 56 Gy in 33 fractions"
1088585|NCT00593840|O1|Outcome|Arm 1: IMRT|"CTV1 = 66 Gy in 33 fractions~CTV2 = 60 Gy in 33 fractions~CTV3 = 56 Gy in 33 fractions~CTV3 Proto = 56 Gy in 33 fractions"
1088586|NCT00593840|E1|Reported Event|Arm 1: Intensity Modulated Radiation Therapy (IMRT)|-This study provides guidelines for volume to be contoured during IMRT based on tumor site and stage of tumor site. The clinical tumor volume (CTV)1 will be treated to 66 Cy in 33 fractions or 60 Gy in 30 fractions. The CTV2 will be treated to 54 Gy in 33 fractions or 52 Gy in 30 fractions. The CTV3 will be modified based on tumor site and stage of tumor site in order to reduce volume.
1088587|NCT00593827|B3|Baseline|Total|Total of all reporting groups
1088588|NCT00593827|B2|Baseline|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
1088589|NCT00593827|B1|Baseline|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
1088590|NCT00593827|P2|Participant Flow|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
1088591|NCT00593827|P1|Participant Flow|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
1088592|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
1088593|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
1088594|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
1088595|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
1088596|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
1088597|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
1088598|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
1088599|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
1088600|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
1088601|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
1088614|NCT00593814|B1|Baseline|EXCLUDER Low Permeability|Modified EXCLUDER device with Low Permeability Layer designed to treat abdominal aortic aneurysms with an endovascular surgical technique. This device functions identically to the original EXCLUDER device, however, a low permeability film is included in the device to eliminate migration of serous fluid through the graft.
1088615|NCT00593814|P2|Participant Flow|Original EXCLUDER|Historical Sample from original study of EXCLUDER Device. The original EXCLUDER Device was designed for the endovascular treatment of abdominal aortic aneurysms.
1088616|NCT00593814|P1|Participant Flow|EXCLUDER Low Permeability|Modified EXCLUDER device with Low Permeability Layer designed to treat abdominal aortic aneurysms with an endovascular surgical technique. This device functions identically to the original EXCLUDER device, however, a low permeability film is included in the device to eliminate migration of serous fluid through the graft.
1088617|NCT00593814|O2|Outcome|Original EXCLUDER|Historical Sample from original study of EXCLUDER Device. The original EXCLUDER Device was designed for the endovascular treatment of abdominal aortic aneurysms.
1088618|NCT00593814|O1|Outcome|EXCLUDER Low Permeability|Modified EXCLUDER device with Low Permeability Layer designed to treat abdominal aortic aneurysms with an endovascular surgical technique. This device functions identically to the original EXCLUDER device, however, a low permeability film is included in the device to eliminate migration of serous fluid through the graft.
1088619|NCT00593814|E2|Reported Event|Original EXCLUDER|Historical Sample from original study of EXCLUDER Device. The original EXCLUDER Device was designed for the endovascular treatment of abdominal aortic aneurysms.
1088620|NCT00593814|E1|Reported Event|EXCLUDER Low Permeability|Modified EXCLUDER device with Low Permeability Layer designed to treat abdominal aortic aneurysms with an endovascular surgical technique. This device functions identically to the original EXCLUDER device, however, a low permeability film is included in the device to eliminate migration of serous fluid through the graft.
1088621|NCT00593736|B5|Baseline|Total|Total of all reporting groups
1088622|NCT00593736|B4|Baseline|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088623|NCT00593736|B3|Baseline|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088624|NCT00593736|B2|Baseline|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088625|NCT00593736|B1|Baseline|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088626|NCT00593736|P4|Participant Flow|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088627|NCT00593736|P3|Participant Flow|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088628|NCT00593736|P2|Participant Flow|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088629|NCT00593736|P1|Participant Flow|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088630|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088631|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088632|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088633|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088634|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088635|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088636|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088637|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088638|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088639|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088640|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088641|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088642|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088643|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088644|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088645|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088646|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088647|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088648|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088649|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088650|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088651|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088652|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088653|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088654|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088655|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088656|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1093290|NCT00579137|E1|Reported Event|Single Group|only one group
1088657|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088658|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088659|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088660|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088661|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088662|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088663|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088664|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088665|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088666|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088667|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088668|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088669|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088670|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088671|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088672|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088673|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088674|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088675|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088676|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088677|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088678|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088679|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088680|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088681|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088682|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088683|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088684|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088685|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088686|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088687|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088688|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088689|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088690|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088691|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088692|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088693|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088694|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088695|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088696|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088697|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088698|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088699|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088700|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088701|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088702|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088703|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088704|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088705|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088706|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088707|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088708|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088709|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088710|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088711|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088712|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088713|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088714|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088715|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088716|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088717|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088718|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088719|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088720|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088721|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088722|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088723|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088724|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088725|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088726|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088727|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088728|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088729|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088730|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088731|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088732|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088733|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088734|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088735|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088736|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088737|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088738|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088739|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088740|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088741|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088742|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088743|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088744|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088745|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088746|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088747|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088748|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088749|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088750|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088751|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088752|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088753|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088754|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088755|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088756|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088757|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088758|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088759|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088760|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088761|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088762|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088763|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088764|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088765|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088766|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088767|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088768|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088769|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088770|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088771|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088772|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088773|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088774|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088775|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088776|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088777|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088778|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088779|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088780|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088781|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088782|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088783|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088784|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088785|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088786|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088787|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088788|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088789|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088790|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088791|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088792|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088793|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088794|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088795|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088796|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088797|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088798|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088799|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088800|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088801|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088802|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088803|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088804|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088805|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088806|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088807|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088808|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088809|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088810|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088811|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088812|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088813|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088814|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088815|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088816|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088817|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088818|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088819|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088820|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088821|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088822|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088823|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088824|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088825|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088826|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088827|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088828|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088829|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088830|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088831|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088832|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088833|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088834|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088835|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088836|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088837|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088838|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088839|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088840|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088841|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088842|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088843|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088844|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088845|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088846|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088847|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088848|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088849|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088850|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088851|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088852|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088853|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088854|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088855|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088856|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088857|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088858|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088859|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088860|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088861|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088862|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088863|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088864|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088865|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088866|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088867|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088868|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088869|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088870|NCT00593736|E4|Reported Event|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
1088871|NCT00593736|E3|Reported Event|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
1088872|NCT00593736|E2|Reported Event|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
1088873|NCT00593736|E1|Reported Event|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
1088874|NCT00593684|B3|Baseline|Total|Total of all reporting groups
1088875|NCT00593684|B2|Baseline|Control|Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).
1088876|NCT00593684|B1|Baseline|Algidex Patch|
1088877|NCT00593684|P2|Participant Flow|Control|Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).
1088878|NCT00593684|P1|Participant Flow|Algidex Patch|
1088879|NCT00593684|O2|Outcome|Control|Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).
1088880|NCT00593684|O1|Outcome|Algidex Patch|The group of patients that were randomized to receive the Algidex patch during the study.
1088881|NCT00593684|O2|Outcome|Control|Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).
1088882|NCT00593684|O1|Outcome|Algidex Patch|The group of patients that were randomized to receive the Algidex patch during the study.
1089142|NCT00592943|O2|Outcome|Armodafinil (250mg)|One 250 mg orally administered dose of Armodafini before PET scan.
1088883|NCT00593684|O2|Outcome|Control|Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).
1088884|NCT00593684|O1|Outcome|Algidex Patch|The group of patients that were randomized to receive the Algidex patch during the study.
1091569|NCT00585182|E1|Reported Event|Enoxaparin 0.5mg/kg Once Daily|
1088885|NCT00593684|O2|Outcome|Control|Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).
1088886|NCT00593684|O1|Outcome|Algidex Patch|The group of patients that were randomized to receive the Algidex patch during the study.
1088887|NCT00593684|E2|Reported Event|Control|Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).
1088888|NCT00593684|E1|Reported Event|Algidex Patch|
1088889|NCT00593645|B1|Baseline|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
1088890|NCT00593645|P1|Participant Flow|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
1088891|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
1088892|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
1088893|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
1088894|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
1088895|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
1088896|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
1088897|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
1088898|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
1088899|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
1088900|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
1088931|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1089143|NCT00592943|O1|Outcome|Armodafinil (100mg)|One 100 mg orally administered dose of Armodafini before PET scan.
1088901|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
1088902|NCT00593645|E1|Reported Event|Arm 1|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
1088903|NCT00593606|B1|Baseline|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088904|NCT00593606|P1|Participant Flow|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088905|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088906|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088907|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088908|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088909|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088910|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088911|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088912|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088913|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088914|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088915|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088916|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088917|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088918|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088919|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088920|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088921|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088922|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088923|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088924|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088925|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088926|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088927|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088928|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088929|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088930|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1172358|NCT00381303|O2|Outcome|Male|
1088932|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088933|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088934|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088935|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088936|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088937|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088938|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088939|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088940|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088941|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088942|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088943|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088944|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088945|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088946|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088947|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088948|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088949|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088950|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088951|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088952|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088953|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088954|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088955|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088956|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088957|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088958|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088959|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088960|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088961|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088962|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088963|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1093291|NCT00579111|B3|Baseline|Total|Total of all reporting groups
1088964|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088965|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088966|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088967|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088968|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088969|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088970|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088971|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088972|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088973|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088974|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088975|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088976|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088977|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088978|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088979|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088980|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088981|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088982|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088983|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088984|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088985|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088986|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088987|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088988|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088989|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088990|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088991|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088992|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088993|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088994|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088995|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1093580|NCT00578734|O2|Outcome|Sham Air|Sham air (placebo) instillation
1088996|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088997|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088998|NCT00593606|E1|Reported Event|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
1088999|NCT00593450|B5|Baseline|Total|Total of all reporting groups
1089000|NCT00593450|B4|Baseline|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089001|NCT00593450|B3|Baseline|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089002|NCT00593450|B2|Baseline|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
1089003|NCT00593450|B1|Baseline|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
1089004|NCT00593450|P4|Participant Flow|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089005|NCT00593450|P3|Participant Flow|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089006|NCT00593450|P2|Participant Flow|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
1089007|NCT00593450|P1|Participant Flow|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
1089008|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089009|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089010|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
1089011|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
1089012|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089013|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089014|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
1089015|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
1089016|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089017|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089018|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
1089019|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
1089020|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089021|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089022|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
1089023|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
1089024|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089025|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089026|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
1089027|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
1089028|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089029|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089030|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
1089139|NCT00592943|B1|Baseline|Armodafinil (100mg)|One 100 mg orally administered dose of Armodafini before PET scan.
1089031|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
1089032|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1091710|NCT00584831|O3|Outcome|Omafilcon A|omafilcon A toric
1089033|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089034|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
1089035|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
1089036|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089037|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089038|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
1089039|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
1089040|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089041|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089042|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
1089043|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
1089044|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089045|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089046|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
1089047|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
1089048|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089049|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089050|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
1089051|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
1089052|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089053|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089054|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
1089055|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
1089056|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089057|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089058|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
1089059|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
1089060|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089061|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089062|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
1089063|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
1089064|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089065|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089140|NCT00592943|P2|Participant Flow|Armodafinil (250mg)|One 250 mg orally administered dose of Armodafini before PET scan.
1089066|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
1089067|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
1089068|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089069|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089070|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
1089071|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
1089072|NCT00593450|E4|Reported Event|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089073|NCT00593450|E3|Reported Event|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
1089074|NCT00593450|E2|Reported Event|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
1089075|NCT00593450|E1|Reported Event|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
1089076|NCT00593372|B3|Baseline|Total|Total of all reporting groups
1089077|NCT00593372|B2|Baseline|Continuing Medication Only|Participants continue on current medication and are assessed at beginning and end of study duration.
1089078|NCT00593372|B1|Baseline|Spaced Retrieval Therapy|Participants continue on current medication but participate in spaced retrieval memory training, as well.
1089079|NCT00593372|P2|Participant Flow|Continuing Medication Only|Participants continue on current medication and are assessed at beginning and end of study duration.
1089080|NCT00593372|P1|Participant Flow|Spaced Retrieval Therapy|Participants continue on current medication but participate in spaced retrieval memory training, as well.
1089081|NCT00593372|O2|Outcome|Continuing Medication Only|Participants continue on current medication and are assessed at beginning and end of study duration.
1089082|NCT00593372|O1|Outcome|Spaced Retrieval Therapy|Participants continue on current medication but participate in spaced retrieval memory training, as well.
1089083|NCT00593372|E2|Reported Event|Continuing Medication Only|Participants continue on current medication and are assessed at beginning and end of study duration.
1089084|NCT00593372|E1|Reported Event|Spaced Retrieval Therapy|Participants continue on current medication but participate in spaced retrieval memory training, as well.
1089085|NCT00593346|B1|Baseline|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
1089086|NCT00593346|P1|Participant Flow|Accelerated Partial Breast Bracytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
1089087|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
1089088|NCT00593346|O1|Outcome|Accelerated Partial Breast Bracytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
1089089|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
1089090|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
1089091|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
1089092|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
1089093|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
1089094|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
1089095|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
1089141|NCT00592943|P1|Participant Flow|Armodafinil (100mg)|One 100 mg orally administered dose of Armodafini before PET scan.
1172359|NCT00381303|O1|Outcome|Female|
1089096|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
1205605|NCT00282672|O1|Outcome|All Groups|
1089097|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
1089098|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
1089099|NCT00593346|E1|Reported Event|Accelerated Partial Breast Bracytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
1089100|NCT00593333|B3|Baseline|Total|Total of all reporting groups
1089101|NCT00593333|B2|Baseline|Trigen|Trochanteric entry portal for the antegrade nailing was used for this group. These subjects received a TRigen Trochanteric Angegrade Nail (TAN) that incorporates a 4 degree valgus bend in the proximal aspect of the nail.
1089102|NCT00593333|B1|Baseline|Standard Treatment|Pirformis fossa entry portal for the antegrade nailing was used for this group. Received either a TRIGEN antegrade femoral nail or an Antegrade Femoral Nail.
1089103|NCT00593333|P2|Participant Flow|Trigen|Trochanteric entry portal for the antegrade nailing was used for this group. These subjects received a TRigen Trochanteric Angegrade Nail (TAN) manufactured by Smith & Nephew that incorporates a 4 degree valgus bend in the proximal aspect of the nail.
1089104|NCT00593333|P1|Participant Flow|Standard Treatment|Piriformis fossa entry portal for the antegrade nailing was used for this group. Received either a TRIGEN antegrade femoral nail manufactured by Smith & Nephew (Memphis, Tennessee) or an Antegrade Femoral Nail manufactured by Synthes (West Chester, Pennsylvania)
1089105|NCT00593333|O2|Outcome|Trigen|Trochanteric entry portal for the antegrade nailing was used for this group. These subjects received a TRigen Trochanteric Angegrade Nail (TAN) manufactured by Smith & Nephew that incorporates a 4 degree valgus bend in the proximal aspect of the nail.
1089106|NCT00593333|O1|Outcome|Standard Treatment|Piriformis fossa entry portal for the antegrade nailing was used for this group. Received either a TRIGEN antegrade femoral nail manufactured by Smith & Nephew (Memphis, Tennessee) or an Antegrade Femoral Nail manufactured by Synthes (West Chester, Pennsylvania)
1089107|NCT00593333|E2|Reported Event|Group B|Trochanteric entry portal for the antegrade nailing was used for this group. These subjects received a TRigen Trochanteric Angegrade Nail (TAN) manufactured by Smith & Nephew that incorporates a 4 degree valgus bend in the proximal aspect of the nail.
1089108|NCT00593333|E1|Reported Event|Group A|Piriformis fossa entry portal for the antegrade nailing was used for this group. Received either a TRIGEN antegrade femoral nail manufactured by Smith & Nephew (Memphis, Tennessee) or an Antegrade Femoral Nail manufactured by Synthes (West Chester, Pennsylvania)
1089109|NCT00593320|B3|Baseline|Total|Total of all reporting groups
1089110|NCT00593320|B2|Baseline|Arm 2: High Dose|High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
1089111|NCT00593320|B1|Baseline|Arm 1: Low Dose|Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
1089112|NCT00593320|P2|Participant Flow|Arm 2: High Dose|High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
1089113|NCT00593320|P1|Participant Flow|Arm 1: Low Dose|Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
1089114|NCT00593320|O2|Outcome|Arm 2: High Dose|High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
1089115|NCT00593320|O1|Outcome|Arm 1: Low Dose|Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
1089116|NCT00593320|O2|Outcome|Arm 2: High Dose|High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
1089117|NCT00593320|O1|Outcome|Arm 1: Low Dose|Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
1089118|NCT00593320|O2|Outcome|Arm 2: High Dose|High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
1089119|NCT00593320|O1|Outcome|Arm 1: Low Dose|Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
1089120|NCT00593320|O2|Outcome|Arm 2: High Dose|High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
1089121|NCT00593320|O1|Outcome|Arm 1: Low Dose|Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
1089122|NCT00593320|E2|Reported Event|Arm 2: High Dose|High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
1089123|NCT00593320|E1|Reported Event|Arm 1: Low Dose|Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
1089124|NCT00593112|B3|Baseline|Total|Total of all reporting groups
1089125|NCT00593112|B2|Baseline|Control|Healthy Volunteer Control group
1089126|NCT00593112|B1|Baseline|OROS Methylphenidate|OROS = Osmotic-controlled Release Oral delivery System
1089127|NCT00593112|P2|Participant Flow|Control|Healthy Volunteer Control group
1089128|NCT00593112|P1|Participant Flow|OROS Methylphenidate|OROS = Osmotic-controlled Release Oral delivery System
1089129|NCT00593112|O2|Outcome|Control|Healthy Volunteer Control group
1089130|NCT00593112|O1|Outcome|OROS Methylphenidate|OROS = Osmotic-controlled Release Oral delivery System
1089131|NCT00593112|O2|Outcome|Control|Healthy Volunteer Control group
1089132|NCT00593112|O1|Outcome|OROS Methylphenidate|OROS = Osmotic-controlled Release Oral delivery System
1089133|NCT00593112|O2|Outcome|Control|Healthy Volunteer Control group
1089134|NCT00593112|O1|Outcome|OROS Methylphenidate|OROS = Osmotic-controlled Release Oral delivery System
1089135|NCT00593112|E2|Reported Event|Control|Healthy Volunteer Control group
1089136|NCT00593112|E1|Reported Event|OROS Methylphenidate|OROS = Osmotic-controlled Release Oral delivery System
1089137|NCT00592943|B3|Baseline|Total|Total of all reporting groups
1089138|NCT00592943|B2|Baseline|Armodafinil (250mg)|One 250 mg orally administered dose of Armodafini before PET scan.
1093737|NCT00578331|E1|Reported Event|Placebo Nasal Spray|
1089144|NCT00592943|O2|Outcome|Armodafinil (250mg)|One 250 mg orally administered dose of Armodafini before PET scan.
1089145|NCT00592943|O1|Outcome|Armodafinil (100mg)|One 100 mg orally administered dose of Armodafini before PET scan.
1205606|NCT00282672|O1|Outcome|All Groups|
1089146|NCT00592943|O2|Outcome|Armodafinil (250mg)|One 250 mg orally administered dose of Armodafini before PET scan.
1089147|NCT00592943|O1|Outcome|Armodafinil (100mg)|One 100 mg orally administered dose of Armodafini before PET scan.
1089148|NCT00592943|E2|Reported Event|Armodafinil (250mg)|One 250 mg orally administered dose of Armodafini before PET scan.
1089149|NCT00592943|E1|Reported Event|Armodafinil (100mg)|One 100 mg orally administered dose of Armodafini before PET scan.
1089150|NCT00592904|B5|Baseline|Total|Total of all reporting groups
1089151|NCT00592904|B4|Baseline|PHN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
1089152|NCT00592904|B3|Baseline|Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
1089153|NCT00592904|B2|Baseline|PDN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
1089154|NCT00592904|B1|Baseline|Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
1089155|NCT00592904|P4|Participant Flow|PHN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
1089156|NCT00592904|P3|Participant Flow|Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
1089157|NCT00592904|P2|Participant Flow|PDN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
1089158|NCT00592904|P1|Participant Flow|Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
1089159|NCT00592904|O4|Outcome|PHN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
1089160|NCT00592904|O3|Outcome|Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
1089161|NCT00592904|O2|Outcome|PDN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
1089162|NCT00592904|O1|Outcome|Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
1089163|NCT00592904|O4|Outcome|PHN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
1089164|NCT00592904|O3|Outcome|Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
1089165|NCT00592904|O2|Outcome|PDN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
1089166|NCT00592904|O1|Outcome|Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
1089205|NCT00592839|O2|Outcome|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
1089206|NCT00592839|O1|Outcome|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
1172360|NCT00381303|O5|Outcome|Other|
1089208|NCT00592839|O2|Outcome|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
1089209|NCT00592839|O1|Outcome|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
1205607|NCT00282672|O1|Outcome|All Groups|
1089167|NCT00592904|O4|Outcome|PHN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
1089168|NCT00592904|O3|Outcome|Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
1089169|NCT00592904|O2|Outcome|PDN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
1089170|NCT00592904|O1|Outcome|Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
1089171|NCT00592904|O4|Outcome|PHN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
1089172|NCT00592904|O3|Outcome|Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
1089173|NCT00592904|O2|Outcome|PDN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
1089174|NCT00592904|O1|Outcome|Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
1089175|NCT00592904|O4|Outcome|PHN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
1089176|NCT00592904|O3|Outcome|Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
1089177|NCT00592904|O2|Outcome|PDN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
1089178|NCT00592904|O1|Outcome|Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
1089179|NCT00592904|E4|Reported Event|Post Herpetic Neuralgia|The participants that were being treated for PHN in the double-blind study and received either placebo or perampanel.
1089180|NCT00592904|E3|Reported Event|Painful Diabetic Neuropathy|The participants that were being treated for PDN in the double-blind study and received either placebo or perampanel.
1089181|NCT00592904|E2|Reported Event|Perampanel|The participants that had previously received perampanel during the double-blind study.
1089182|NCT00592904|E1|Reported Event|Placebo|The participants who had previously received placebo during the double-blind study.
1089183|NCT00592852|B1|Baseline|Fluoxetine|
1089184|NCT00592852|P1|Participant Flow|Fluoxetine|
1089185|NCT00592852|O1|Outcome|Fluoxetine|
1089186|NCT00592852|O1|Outcome|Fluoxetine|
1089187|NCT00592852|E1|Reported Event|Fluoxetine|
1089188|NCT00592839|B4|Baseline|Total|Total of all reporting groups
1089189|NCT00592839|B3|Baseline|Placebo Daily|Placebo tablet daily orally
1089190|NCT00592839|B2|Baseline|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
1089191|NCT00592839|B1|Baseline|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
1089192|NCT00592839|P3|Participant Flow|Placebo Daily|Placebo tablet daily orally
1089193|NCT00592839|P2|Participant Flow|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
1089194|NCT00592839|P1|Participant Flow|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
1089195|NCT00592839|O3|Outcome|Placebo Daily|Placebo tablet daily orally
1089196|NCT00592839|O2|Outcome|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
1089197|NCT00592839|O1|Outcome|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
1089198|NCT00592839|O3|Outcome|Placebo Daily|Placebo tablet daily orally
1089199|NCT00592839|O2|Outcome|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
1089200|NCT00592839|O1|Outcome|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
1089201|NCT00592839|O3|Outcome|Placebo Daily|Placebo tablet daily orally
1089202|NCT00592839|O2|Outcome|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
1089203|NCT00592839|O1|Outcome|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
1089204|NCT00592839|O3|Outcome|Placebo Daily|Placebo tablet daily orally
1089207|NCT00592839|O3|Outcome|Placebo Daily|Placebo tablet daily orally
1089211|NCT00592839|O2|Outcome|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
1089212|NCT00592839|O1|Outcome|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
1089213|NCT00592839|E3|Reported Event|Placebo Daily|Placebo tablet daily orally
1089214|NCT00592839|E2|Reported Event|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
1089215|NCT00592839|E1|Reported Event|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
1089216|NCT00592774|B6|Baseline|Total|Total of all reporting groups
1089217|NCT00592774|B5|Baseline|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
1089218|NCT00592774|B4|Baseline|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
1089219|NCT00592774|B3|Baseline|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
1089220|NCT00592774|B2|Baseline|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
1089221|NCT00592774|B1|Baseline|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
1089222|NCT00592774|P5|Participant Flow|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
1089223|NCT00592774|P4|Participant Flow|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
1089224|NCT00592774|P3|Participant Flow|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
1089225|NCT00592774|P2|Participant Flow|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
1089226|NCT00592774|P1|Participant Flow|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
1089227|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
1089228|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
1089229|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
1089230|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
1089231|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
1089232|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
1089233|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
1089234|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
1089235|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
1089236|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
1089237|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
1089238|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
1089239|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
1089240|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
1093738|NCT00578318|B3|Baseline|Total|Total of all reporting groups
1089241|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
1089242|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
1089243|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
1089244|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
1089245|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
1089246|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
1089247|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
1089248|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
1089249|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
1089250|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
1089251|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
1089252|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
1089253|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
1089254|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
1089255|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
1089256|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
1089257|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
1089258|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
1089259|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
1089260|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
1089261|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
1089262|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
1089263|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
1089264|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
1089265|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
1089266|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
1089267|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
1089268|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
1089269|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
1089270|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
1089271|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
1089272|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
1089273|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
1089274|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
1089275|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
1089276|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
1089277|NCT00592774|E5|Reported Event|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
1089278|NCT00592774|E4|Reported Event|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
1089279|NCT00592774|E3|Reported Event|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
1089280|NCT00592774|E2|Reported Event|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
1089281|NCT00592774|E1|Reported Event|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
1089282|NCT00592761|B1|Baseline|Entire Study Population|This includes all participants. Half received treatment then no treatment and have received no treatment then treatment.
1089283|NCT00592761|P2|Participant Flow|Treatment Then No Treatment|Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
1089284|NCT00592761|P1|Participant Flow|No Treatment Then Treatment|Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
1089285|NCT00592761|O2|Outcome|Treatment Then No Treatment|Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
1089286|NCT00592761|O1|Outcome|No Treatment Then Treatment|Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
1089287|NCT00592761|O2|Outcome|Treatment Then No Treatment|Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
1089288|NCT00592761|O1|Outcome|No Treatment Then Treatment|Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
1089289|NCT00592761|O2|Outcome|Treatment Then No Treatment|Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
1089290|NCT00592761|O1|Outcome|No Treatment Then Treatment|Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
1089291|NCT00592761|O2|Outcome|Treatment Then No Treatment|Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
1089292|NCT00592761|O1|Outcome|No Treatment Then Treatment|Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
1089293|NCT00592761|E2|Reported Event|Treatment Then No Treatment|Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
1089294|NCT00592761|E1|Reported Event|No Treatment Then Treatment|Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
1089295|NCT00592683|B3|Baseline|Total|Total of all reporting groups
1089296|NCT00592683|B2|Baseline|Aripiprazole + Placebo|treatment with aripiprazole + placebo
1089297|NCT00592683|B1|Baseline|Aripiprazole + Fish Oil|treatment with aripiprazole + fish oil
1089298|NCT00592683|P2|Participant Flow|Aripiprazole + Placebo|treatment with aripiprazole + placebo
1089299|NCT00592683|P1|Participant Flow|Aripiprazole + Fish Oil|treatment with aripiprazole + fish oil
1089300|NCT00592683|O2|Outcome|Aripiprazole + Placebo|treatment with aripiprazole + placebo
1089301|NCT00592683|O1|Outcome|Aripiprazole + Fish Oil|treatment with aripiprazole + fish oil
1089302|NCT00592683|O2|Outcome|Aripiprazole + Placebo|treatment with aripiprazole + placebo
1089303|NCT00592683|O1|Outcome|Aripiprazole + Fish Oil|treatment with aripiprazole + fish oil
1089304|NCT00592683|E2|Reported Event|Aripiprazole + Placebo|treatment with aripiprazole + placebo
1089305|NCT00592683|E1|Reported Event|Aripiprazole + Fish Oil|treatment with aripiprazole + fish oil
1089306|NCT00592631|B3|Baseline|Total|Total of all reporting groups
1089307|NCT00592631|B2|Baseline|Sham|Subjects used SHAM set at 0-2 cmH20 for 7-10 nights
1089308|NCT00592631|B1|Baseline|CPAP|Subjects used CPAP set at 8-10 cmH20 for 7-10 nights.
1172361|NCT00381303|O4|Outcome|Asian|
1089309|NCT00592631|P2|Participant Flow|Sham Treatment|Adults with stable asthma and normal spirometry used SHAM with a mask pressure Mask pressure between 0 and 2 cm H20 for 7 to 10 nights prior to the follow-up assessment.
1089310|NCT00592631|P1|Participant Flow|Continuous Positivie Airway Pressure|Adult with stable asthma and normal spirometry used CPAP with a mask pressure between 8 and 10 cm H20 for 7 to 10 nights prior to the follow-up assessment.
1089311|NCT00592631|O2|Outcome|Sham|Subjects used sham set at 0-2 cmH20 for 7-10 nights
1089312|NCT00592631|O1|Outcome|CPAP|Subjects used CPAP set at 8-10 cmH20 for 7-10 nights.
1089313|NCT00592631|E2|Reported Event|Sham|
1089314|NCT00592631|E1|Reported Event|Continuous Positive Airway Pressure|
1089315|NCT00592488|B3|Baseline|Total|Total of all reporting groups
1089316|NCT00592488|B2|Baseline|ALC Then Placebo|ALC for first 12 hours then placebo for next 6 hours
1089317|NCT00592488|B1|Baseline|Placebo Then ALC|Placebo for first 6 hours then ALC for 12 hours
1089318|NCT00592488|P2|Participant Flow|ALC Then Placebo|ALC for first 12 hours then placebo for next 6 hours
1089319|NCT00592488|P1|Participant Flow|Placebo Then ALC|Placebo for first 6 hours then ALC for 12 hours
1089320|NCT00592488|O2|Outcome|Placebo Then Acetyl-L-Carnitine (ALC)|Placebo for hours 0-6 then ALC for hours 6-18
1089321|NCT00592488|O1|Outcome|Acetyl-L-Carnitine (ALC) Then Placebo|ALC for hours 0-12 and placebo hours 12-18
1089322|NCT00592488|E2|Reported Event|ALC Then Placebo|ALC for first 12 hours then placebo for next 6 hours
1089323|NCT00592488|E1|Reported Event|Placebo Then ALC|Placebo for first 6 hours then ALC for 12 hours
1089324|NCT00592475|B4|Baseline|Total|Total of all reporting groups
1089325|NCT00592475|B3|Baseline|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
1089326|NCT00592475|B2|Baseline|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
1089327|NCT00592475|B1|Baseline|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
1089328|NCT00592475|P3|Participant Flow|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
1089329|NCT00592475|P2|Participant Flow|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
1089330|NCT00592475|P1|Participant Flow|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
1089331|NCT00592475|O3|Outcome|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
1089332|NCT00592475|O2|Outcome|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
1089333|NCT00592475|O1|Outcome|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
1089334|NCT00592475|O3|Outcome|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
1089335|NCT00592475|O2|Outcome|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
1089336|NCT00592475|O1|Outcome|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
1089337|NCT00592475|O3|Outcome|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
1089338|NCT00592475|O2|Outcome|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
1089339|NCT00592475|O1|Outcome|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
1089340|NCT00592475|O3|Outcome|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
1089341|NCT00592475|O2|Outcome|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
1089342|NCT00592475|O1|Outcome|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
1089343|NCT00592475|O3|Outcome|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
1089344|NCT00592475|O2|Outcome|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
1089345|NCT00592475|O1|Outcome|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
1089346|NCT00592475|O3|Outcome|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
1089347|NCT00592475|O2|Outcome|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
1089348|NCT00592475|O1|Outcome|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
1089349|NCT00592475|E3|Reported Event|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
1089350|NCT00592475|E2|Reported Event|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
1089351|NCT00592475|E1|Reported Event|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
1089352|NCT00592384|B3|Baseline|Total|Total of all reporting groups
1089353|NCT00592384|B2|Baseline|Venlafaxine XR|venlafaxine XR: Once daily oral dose ranging from 37.5 mg up to 300 mg
1089354|NCT00592384|B1|Baseline|Placebo Control|placebo: identically encapsulated inactive substance
1089355|NCT00592384|P2|Participant Flow|Venlafaxine XR|venlafaxine XR: Once daily oral dose ranging from 37.5 mg up to 300 mg
1089356|NCT00592384|P1|Participant Flow|Placebo Control|placebo: identically encapsulated inactive substance
1089357|NCT00592384|O2|Outcome|Venlafaxine XR|venlafaxine XR: Once daily oral dose ranging from 37.5 mg up to 300 mg
1089358|NCT00592384|O1|Outcome|Placebo Control|placebo: identically encapsulated inactive substance
1089359|NCT00592384|O2|Outcome|Venlafaxine XR|venlafaxine XR: Once daily oral dose ranging from 37.5 mg up to 300 mg
1089360|NCT00592384|O1|Outcome|Placebo Control|placebo: identically encapsulated inactive substance
1089361|NCT00592384|E2|Reported Event|Venlafaxine XR|venlafaxine XR: Once daily oral dose ranging from 37.5 mg up to 300 mg
1089362|NCT00592384|E1|Reported Event|Placebo Control|placebo: identically encapsulated inactive substance
1089949|NCT00590759|O1|Outcome|Thoracic Endograft|GORE TAG® Thoracic Endoprosthesis: implant
1089363|NCT00592358|B1|Baseline|Paliperidone|Open label treatment with Invega (Paliperidone) once daily, with dosage of 3mg per day, titrated in 3mg increments to a maximum of 6mg per day based on subject age, weight and tolerance.
1089364|NCT00592358|P1|Participant Flow|Paliperidone|Open label treatment with Invega (Paliperidone) once daily, with dosage of 3mg per day, titrated in 3mg increments to a maximum of 6mg per day based on subject age, weight and tolerance.
1089365|NCT00592358|O1|Outcome|Paliperidone|Open-label treatment with Paliperidone.
1089366|NCT00592358|O1|Outcome|Paliperidone|Open-label treatment with Paliperidone.
1089367|NCT00592358|E1|Reported Event|Paliperidone|Open label treatment with Invega (Paliperidone) once daily, with dosage of 3mg per day, titrated in 3mg increments to a maximum of 6mg per day based on subject age, weight and tolerance.
1089368|NCT00592319|B3|Baseline|Total|Total of all reporting groups
1089369|NCT00592319|B2|Baseline|Experimental|treated with once-time PDL, followed by oral taking of 9-month Celecoxib, in 15 cases
1089370|NCT00592319|B1|Baseline|Control|"treated with routine surgery (CO2 laser or cold microsurgery), in 15 cases"
1089371|NCT00592319|P2|Participant Flow|Experimental|once-time PDL surgery at 6.0-8.0 W, followed by oral taking of Celecoxib (100mg,BID)for 9 months
1089372|NCT00592319|P1|Participant Flow|Control|"once-time routine surgery with (either of CO2 laser at continue model and 10.0-20.0 W, or cold surgery with micro-instruments), in 15 subjects"
1089373|NCT00592319|O2|Outcome|Experienment|treated with once-time PDL, followed by oral taking of Celebrex (100mg,BID) for 9 months
1089374|NCT00592319|O1|Outcome|Control|"treated with once-time routine surgery (CO2 laser or cold microsurgery)"
1089375|NCT00592319|O2|Outcome|Experiment|treated with both of once-time PDL and 9-month Celebrex
1089376|NCT00592319|O1|Outcome|Control|treated with once-time routine surgery
1089377|NCT00592319|E2|Reported Event|Control|treatd with CO2 laser or microsurgery
1089378|NCT00592319|E1|Reported Event|Experiment|treated with both of PDL and Celecoxib
1089379|NCT00592176|B1|Baseline|Bevacizumab|The participants received an initial 0.5mL subconjunctival injection of bevacizumab(2.5mg/mL) beneath the pterygium at the limbus and again every month for a total of 3 injections.
1089380|NCT00592176|P1|Participant Flow|Bevacizumab|The participants received an initial 0.5mL subconjunctival injection of bevacizumab(2.5mg/mL) beneath the pterygium at the limbus and again every month for a total of 3 injections.
1089381|NCT00592176|O1|Outcome|Bevacizumab|Patients receiving bevacizumab treatment.
1089382|NCT00592176|O1|Outcome|Bevacizumab|Patients receiving bevacizumab treatment.
1089383|NCT00592176|E1|Reported Event|Bevacizumab|The participants received an initial 0.5mL subconjunctival injection of bevacizumab(2.5mg/mL) beneath the pterygium at the limbus and again every month for a total of 3 injections.
1089384|NCT00592124|B7|Baseline|Total|Total of all reporting groups
1089385|NCT00592124|B6|Baseline|V, OV, O|"Vaginal tenofovir gel application for Weeks 1 through 6, oral TDF and vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
1089386|NCT00592124|B5|Baseline|O, OV, V|"Oral TDF for Weeks 1 through 6, oral TDF and vaginal tenofovir gel application for Weeks 8 through 13, and vaginal tenofovir gel application for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
1089387|NCT00592124|B4|Baseline|OV, V, O|"Oral TDF and vaginal tenofovir gel application for Weeks 1 through 6, vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
1089388|NCT00592124|B3|Baseline|OV, O, V|"Oral TDF and vaginal tenofovir gel application for Weeks 1 through 6, oral TDF for Weeks 8 through 13, and vaginal tenofovir gel application for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
1089389|NCT00592124|B2|Baseline|V, O, OV|"Vaginal tenofovir gel application for Weeks 1 through 6, oral TDF for Weeks 8 through 13, and oral TDF and vaginal tenofovir gel application for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
1089390|NCT00592124|B1|Baseline|O, V, OV|"Oral tenofovir disoproxil fumarate (TDF) for Weeks 1 through 6, vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF and vaginal tenofovir gel application for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
1089391|NCT00592124|P6|Participant Flow|V, OV, O|"Vaginal tenofovir gel application for Weeks 1 through 6, oral TDF and vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
1089392|NCT00592124|P5|Participant Flow|O, OV, V|"Oral TDF for Weeks 1 through 6, oral TDF and vaginal tenofovir gel application for Weeks 8 through 13, and vaginal tenofovir gel application for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
1089393|NCT00592124|P4|Participant Flow|OV, V, O|"Oral TDF and vaginal tenofovir gel application for Weeks 1 through 6, vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
1089394|NCT00592124|P3|Participant Flow|OV, O, V|"Oral TDF and vaginal tenofovir gel application for Weeks 1 through 6, oral TDF for Weeks 8 through 13, and vaginal tenofovir gel application for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
1089395|NCT00592124|P2|Participant Flow|V, O, OV|"Vaginal tenofovir gel application for Weeks 1 through 6, oral TDF for Weeks 8 through 13, and oral TDF and vaginal tenofovir gel application for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
1089396|NCT00592124|P1|Participant Flow|O, V, OV|"Oral tenofovir disoproxil fumarate (TDF) for Weeks 1 through 6, vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF and vaginal tenofovir gel application for Weeks 15 through 20~Tenofovir disoproxil fumarate: 300 mg tablet daily~Tenofovir gel: 1 gm/100 ml of 1% gel vaginally daily"
1089397|NCT00592124|O3|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
1089398|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
1172362|NCT00381303|O3|Outcome|Hispanic|
1089399|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
1091711|NCT00584831|O2|Outcome|Senofilcon A|senofilcon A toric
1089400|NCT00592124|O3|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
1089401|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
1089402|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir)
1089403|NCT00592124|O2|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
1089404|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
1089405|NCT00592124|O2|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
1089406|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
1089407|NCT00592124|O2|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
1089408|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
1089409|NCT00592124|O2|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
1089410|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
1089411|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
1089412|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
1089413|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
1089414|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
1089415|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
1089416|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
1089417|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
1089418|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
1089419|NCT00592124|O3|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
1089420|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
1089421|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
1089422|NCT00592124|O3|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
1089423|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
1089424|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
1089425|NCT00592124|O3|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
1089426|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
1089427|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
1089428|NCT00592124|O3|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
1089429|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
1089430|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
1089431|NCT00592124|O3|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
1089432|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
1089433|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
1089434|NCT00592124|O3|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
1089435|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
1089436|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir)
1089437|NCT00592124|O3|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
1089438|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
1089439|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir)
1089440|NCT00592124|O3|Outcome|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
1089441|NCT00592124|O2|Outcome|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
1089442|NCT00592124|O1|Outcome|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir)
1089443|NCT00592124|E3|Reported Event|Vaginal Tenofovir|Tenofovir 1% gel (vaginal tenofovir)
1089444|NCT00592124|E2|Reported Event|Oral Tenofovir|TDF 300 mg tablet (oral tenofovir)
1089445|NCT00592124|E1|Reported Event|Vaginal and Oral Tenofovir|TDF 300 mg tablet (oral tenofovir) and tenofovir 1% gel (vaginal tenofovir).
1089446|NCT00592072|B1|Baseline|Overall Number of Subjects|12 subjects started the study and 10 completed the study, however 11 subjects are reported in the baseline characteristics because one subjects withdrew before baseline data was collected.
1089447|NCT00592072|P2|Participant Flow|Placebo Intervention First, Then MCT Intervention|A total of 40 grams of cherry-flavored water sweetened with sucralose is ingested at 25-min intervals with front loading of 20 grams then 10 grams twice
1089448|NCT00592072|P1|Participant Flow|MCT Intervention First, Then Placebo|A total of 40 grams of medium-chain triglycerides (derived from coconut oil containing 67% octanoate, 27% decanaote, and 6% other fatty acids) is ingested at 25-min intervals with front loading of 20 grams then 10 grams twice
1089449|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
1089450|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
1089451|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
1089452|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
1089453|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
1089950|NCT00590759|O1|Outcome|Thoracic Endograft|GORE TAG® Thoracic Endoprosthesis: implant
1089454|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
1089455|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
1089456|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
1089457|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
1089458|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
1089459|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
1089460|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
1089461|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
1089462|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
1089463|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
1089464|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
1089465|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
1089466|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
1089467|NCT00592072|E2|Reported Event|Placebo Intervention|
1089468|NCT00592072|E1|Reported Event|MCT Intervention|
1089469|NCT00592007|B1|Baseline|Fulvestrant and Erlotinib|"Single-arm study~Fulvestrant and Erlotinib: Upon enrollment, patients will continue to receive erlotinib daily orally at 150 mg/day or at 100 mg/day if 150 mg was associated with adverse events requiring dose reduction before enrollment in this study. Doses less than 100 mg/day will not be allowed. Fulvestrant will be added intramuscularly 500 mg Day 0, 250 mg Days 14 and 28. In cycles 2 and up, fulvestrant will be given 250 mg on day 28. Patients will receive this therapy until they progress."
1089470|NCT00592007|P1|Participant Flow|Fulvestrand and Erlotinib|"Single-arm study~Fulvestrant and Erlotinib : Upon enrollment, patients will continue to receive erlotinib daily orally at 150 mg/day or at 100 mg/day if 150 mg was associated with adverse events requiring dose reduction before enrollment in this study. Doses less than 100 mg/day will not be allowed. Fulvestrant will be added intramuscularly 500 mg Day 0, 250 mg Days 14 and 28. In cycles 2 and up, fulvestrant will be given 250 mg on day 28. Patients will receive this therapy until they progress."
1089471|NCT00592007|O1|Outcome|Arm A|"Single-arm study~Fulvestrant and Erlotinib: Upon enrollment, patients will continue to receive erlotinib daily orally at 150 mg/day or at 100 mg/day if 150 mg was associated with adverse events requiring dose reduction before enrollment in this study. Doses less than 100 mg/day will not be allowed. Fulvestrant will be added intramuscularly 500 mg Day 0, 250 mg Days 14 and 28. In cycles 2 and up, fulvestrant will be given 250 mg on day 28. Patients will receive this therapy until they progress."
1089472|NCT00592007|O1|Outcome|Arm A|"Single-arm study~Fulvestrant and Erlotinib: Upon enrollment, patients will continue to receive erlotinib daily orally at 150 mg/day or at 100 mg/day if 150 mg was associated with adverse events requiring dose reduction before enrollment in this study. Doses less than 100 mg/day will not be allowed. Fulvestrant will be added intramuscularly 500 mg Day 0, 250 mg Days 14 and 28. In cycles 2 and up, fulvestrant will be given 250 mg on day 28. Patients will receive this therapy until they progress."
1089473|NCT00592007|E1|Reported Event|A: Fulvestrant and Erlotinib|"Single-arm study~Fulvestrant and Erlotinib: Upon enrollment, patients will continue to receive erlotinib daily orally at 150 mg/day or at 100 mg/day if 150 mg was associated with adverse events requiring dose reduction before enrollment in this study. Doses less than 100 mg/day will not be allowed. Fulvestrant will be added intramuscularly 500 mg Day 0, 250 mg Days 14 and 28. In cycles 2 and up, fulvestrant will be given 250 mg on day 28. Patients will receive this therapy until they progress."
1089474|NCT00591864|B1|Baseline|Study Participants|There are no arms or subgroups in this study.
1089475|NCT00591864|P1|Participant Flow|Participants Imaged With MBI and MRI|The group includes patients who underwent both MBI and breast MRI within the same 3 week period.
1089476|NCT00591864|O1|Outcome|Participants Imaged With MBI and MRI|The group includes patients who underwent both MBI and breast MRI within the same 3 week period.
1089477|NCT00591864|O1|Outcome|Participants Imaged With MBI and MRI|The group includes patients who underwent both MBI and breast MRI within the same 3 week period.
1089478|NCT00591864|O1|Outcome|Study Participants|There are no arms or subgroups in this study.
1089479|NCT00591864|E1|Reported Event|Study Participants|There are no arms or subgroups in this study.
1089480|NCT00591851|B1|Baseline|AC Followed by Paclitaxel + Trastuzumab|Doxorubicin and Cyclophosphamide (60/600 mg/m2) X 4 followed by Paclitaxel (175 mg/m2) X 4 every 2 weekly with pegfilgrastim (6mg on day 2) + Trastuzumab x 1 year.
1089481|NCT00591851|P1|Participant Flow|AC Followed by Paclitaxel + Trastuzumab|Doxorubicin and Cyclophosphamide (60/600 mg/m2) X 4 followed by Paclitaxel (175 mg/m2) X 4 every 2 weekly with pegfilgrastim (6mg on day 2) + Trastuzumab x 1 year.
1089482|NCT00591851|O1|Outcome|AC Followed by Paclitaxel + Trastuzumab|Doxorubicin and Cyclophosphamide (60/600 mg/m2) X 4 followed by Paclitaxel (175 mg/m2) X 4 every 2 weekly with pegfilgrastim (6mg on day 2) + Trastuzumab x 1 year.
1089483|NCT00591851|E1|Reported Event|AC Followed by Paclitaxel + Trastuzumab|Doxorubicin and Cyclophosphamide (60/600 mg/m2) X 4 followed by Paclitaxel (175 mg/m2) X 4 every 2 weekly with pegfilgrastim (6mg on day 2) + Trastuzumab x 1 year.
1089484|NCT00591825|B5|Baseline|Total|Total of all reporting groups
1089485|NCT00591825|B4|Baseline|Spider-phobic DCS|Participants with phobia given one administration of 100 mg D-cycloserine (DCS).
1089486|NCT00591825|B3|Baseline|Spider-phobic Placebo|Participants with phobia given one administration of placebo.
1089487|NCT00591825|B2|Baseline|Non-Phobic Control - DCS|Participants without phobia given one administration of 100 mg D-cycloserine (DCS).
1089488|NCT00591825|B1|Baseline|Non-Phobic Control - Placebo|Participants without phobia given one administration of placebo.
1089489|NCT00591825|P4|Participant Flow|Spider-phobic DCS|Participants with phobia given one administration of 100 mg D-cycloserine (DCS).
1205608|NCT00282672|O1|Outcome|All Groups|
1089490|NCT00591825|P3|Participant Flow|Spider-phobic Placebo|Participants with phobia given one administration of placebo.
1089491|NCT00591825|P2|Participant Flow|Non-Phobic Control - DCS|Participants without phobia given one administration of 100 mg D-cycloserine (DCS).
1089492|NCT00591825|P1|Participant Flow|Non-Phobic Control - Placebo|Participants without phobia given one administration placebo.
1089493|NCT00591825|O4|Outcome|Spider-phobic DCS|Participants with phobia were given one administration 100 mg D-cycloserine (DCS).
1089494|NCT00591825|O3|Outcome|Spider-phobic Placebo|Participants with phobia were given one administration placebo.
1089495|NCT00591825|O2|Outcome|Non-Phobic Control - DCS|Participants without phobia were given one administration 100 mg D-cycloserine (DCS).
1089496|NCT00591825|O1|Outcome|Non-Phobic Control - Placebo|Participants without phobia were given one administration placebo.
1089497|NCT00591825|O4|Outcome|Spider-phobic DCS|Participants with phobia were given one administration 100 mg placebo.
1089498|NCT00591825|O3|Outcome|Spider-phobic Placebo|Participants with phobia were given one administration placebo.
1089499|NCT00591825|O2|Outcome|Non-Phobic Control - DCS|Participants without phobia were given one administration 100 mg D-cycloserine (DCS).
1089500|NCT00591825|O1|Outcome|Non-Phobic Control - Placebo|Participants without phobia were given one administration placebo.
1089501|NCT00591825|O4|Outcome|Spider-phobic DCS|Participants with phobia given one administration of 100 mg D-cycloserine (DCS).
1089502|NCT00591825|O3|Outcome|Spider-phobic Placebo|Participants with phobia given one administration of placebo.
1089503|NCT00591825|O2|Outcome|Non-Phobic Control - DCS|Participants without phobia given one administration of 100 mg D-cycloserine (DCS).
1089504|NCT00591825|O1|Outcome|Non-Phobic Control - Placebo|Participants without phobia given one administration of placebo.
1089505|NCT00591825|O4|Outcome|Spider-phobic DCS|Participants without phobia given one administration of 100 mg D-cycloserine.
1089506|NCT00591825|O3|Outcome|Spider-phobic Placebo|Participants with phobia given one administration of placebo.
1089507|NCT00591825|O2|Outcome|Non-Phobic Control - DCS|Participants without phobia given one administration of 100 mg D-cycloserine (DCS).
1089508|NCT00591825|O1|Outcome|Non-Phobic Control - Placebo|Participants without phobia given one administration of placebo.
1089509|NCT00591825|O4|Outcome|Placebo Control|Participants without phobia who were randomized to the Placebo group were given one administration of placebo.
1089510|NCT00591825|O3|Outcome|Placebo Phobic|Participants with phobia who were randomized to the Placebo group were given one administration of placebo.
1089511|NCT00591825|O2|Outcome|DCS Control|Participants without phobia who were randomized to the DCS group were given one administration of 100 mg D-cycloserine (DCS).
1089512|NCT00591825|O1|Outcome|DCS Phobic|Participants with phobia who were randomized to the DCS group were given one administration of 100 mg D-cycloserine (DCS).
1089513|NCT00591825|E4|Reported Event|Spider-phobic DCS|Participants with phobia were given one administration 100 mg D-cycloserine (DCS).
1089514|NCT00591825|E3|Reported Event|Spider-phobic Placebo|Participants with phobia were given one administration placebo.
1089515|NCT00591825|E2|Reported Event|Non-Phobic Control - DCS|Participants without phobia were given one administration 100 mg D-cycloserine (DCS).
1089516|NCT00591825|E1|Reported Event|Non-Phobic Control - Placebo|Participants without phobia were given one administration placebo.
1089517|NCT00591773|B4|Baseline|Total|Total of all reporting groups
1089518|NCT00591773|B3|Baseline|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089519|NCT00591773|B2|Baseline|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089520|NCT00591773|B1|Baseline|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089521|NCT00591773|P3|Participant Flow|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089522|NCT00591773|P2|Participant Flow|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089523|NCT00591773|P1|Participant Flow|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089524|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089525|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089526|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089527|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089528|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089529|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089530|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089531|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089532|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089533|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1172363|NCT00381303|O2|Outcome|Caucasian|
1089793|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1089534|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089535|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089536|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089537|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089538|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089539|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089540|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089541|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089542|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089543|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089544|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089545|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089546|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089547|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089548|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089549|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089550|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089551|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089552|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089553|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089554|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089555|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089556|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089557|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089558|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089559|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089560|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089561|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089562|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089563|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089564|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089565|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089566|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089567|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089568|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089569|NCT00591773|E3|Reported Event|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089570|NCT00591773|E2|Reported Event|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1172364|NCT00381303|O1|Outcome|Black|
1089571|NCT00591773|E1|Reported Event|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
1089572|NCT00591760|B3|Baseline|Total|Total of all reporting groups
1089573|NCT00591760|B2|Baseline|Control|Optimal CHF treatment
1089574|NCT00591760|B1|Baseline|GH Replacement Therapy|Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,00415 mg/kg a day, added to their background optimized CHF therapy
1089575|NCT00591760|P2|Participant Flow|Control|Optimal CHF treatment
1089576|NCT00591760|P1|Participant Flow|GH Replacement Therapy|Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,00415 mg/kg a day, added to their background optimized CHF therapy
1089577|NCT00591760|O2|Outcome|Control|Optimal CHF treatment
1089578|NCT00591760|O1|Outcome|GH Replacement Therapy|Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,00415 mg/kg a day, added to their background optimized CHF therapy
1089579|NCT00591760|E2|Reported Event|Control|Optimal CHF treatment
1089580|NCT00591760|E1|Reported Event|GH Replacement Therapy|Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,00415 mg/kg a day, added to their background optimized CHF therapy
1089581|NCT00591734|B1|Baseline|Intervention|All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
1089582|NCT00591734|P1|Participant Flow|Intervention|All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
1089583|NCT00591734|O1|Outcome|Intervention|All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
1089584|NCT00591734|E1|Reported Event|Intervention|All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
1089585|NCT00591721|B3|Baseline|Total|Total of all reporting groups
1089586|NCT00591721|B2|Baseline|Wait List|Participants assigned to this arm waited 6 weeks after allocation to receive the intervention (teleconference fatigue management)
1089587|NCT00591721|B1|Baseline|Immediate Group|Participants assigned to this arm received the intervention (teleconference fatigue management) immediately after allocation.
1089588|NCT00591721|P2|Participant Flow|Wait List|Participants assigned to this arm waited 6 weeks after allocation to receive the intervention (teleconference fatigue management)
1089589|NCT00591721|P1|Participant Flow|Immediate Group|Participants assigned to this arm received the intervention (teleconference fatigue management) immediately after allocation.
1089590|NCT00591721|O2|Outcome|Wait List|Participants assigned to this arm waited 6 weeks after allocation to receive the intervention (teleconference fatigue management)
1089591|NCT00591721|O1|Outcome|Immediate Group|Participants assigned to this arm received the intervention (teleconference fatigue management) immediately after allocation.
1089592|NCT00591721|E2|Reported Event|Wait List|Participants assigned to this arm waited 6 weeks after allocation to receive the intervention (teleconference fatigue management)
1089593|NCT00591721|E1|Reported Event|Immediate Group|Participants assigned to this arm received the intervention (teleconference fatigue management) immediately after allocation.
1089594|NCT00591591|B3|Baseline|Total|Total of all reporting groups
1089595|NCT00591591|B2|Baseline|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
1089596|NCT00591591|B1|Baseline|Controls|Healthy controls
1089597|NCT00591591|P2|Participant Flow|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
1089598|NCT00591591|P1|Participant Flow|Controls|Healthy controls
1089599|NCT00591591|O2|Outcome|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
1089600|NCT00591591|O1|Outcome|Controls|Healthy controls
1089601|NCT00591591|O2|Outcome|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
1089602|NCT00591591|O1|Outcome|Controls|Healthy controls
1089603|NCT00591591|O2|Outcome|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
1089604|NCT00591591|O1|Outcome|Controls|Healthy controls
1089605|NCT00591591|O2|Outcome|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
1089606|NCT00591591|O1|Outcome|Controls|Healthy controls
1089607|NCT00591591|O2|Outcome|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
1089608|NCT00591591|O1|Outcome|Controls|Healthy controls
1089609|NCT00591591|E2|Reported Event|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
1089610|NCT00591591|E1|Reported Event|Controls|Healthy controls
1089611|NCT00591578|B4|Baseline|Total|Total of all reporting groups
1089612|NCT00591578|B3|Baseline|Valsartan 320 mg QD|"Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.~Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
1089633|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
1089634|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
1089635|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
1089613|NCT00591578|B2|Baseline|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.~Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics).~Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
1089614|NCT00591578|B1|Baseline|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.~Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics).~Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
1089615|NCT00591578|P3|Participant Flow|Valsartan 320 mg QD|"Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.~Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
1089616|NCT00591578|P2|Participant Flow|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.~Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
1089617|NCT00591578|P1|Participant Flow|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.~Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
1089618|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
1089619|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
1089620|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
1089621|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
1089622|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
1089623|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
1089624|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
1089625|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
1089626|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
1089627|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
1089628|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
1089629|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
1089630|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
1089631|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
1089632|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
1089792|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
1089636|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
1089637|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
1089638|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
1089639|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
1089640|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
1089641|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
1089642|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
1089643|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
1089644|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
1089645|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
1089646|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
1089647|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
1089648|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
1089649|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
1089650|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
1089651|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
1089652|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
1089653|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
1089654|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
1089655|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
1089656|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
1089657|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
1089658|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
1089659|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
1089660|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
1089661|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
1089662|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
1089663|NCT00591578|E4|Reported Event|Open Label Extension|Azilsartan medoxomil 40 mg, tablets, orally, independent of participant’s double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics).
1089664|NCT00591578|E3|Reported Event|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
1089665|NCT00591578|E2|Reported Event|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.~Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
1089702|NCT00591305|E1|Reported Event|PDL+DIM Pill|once-time 585 nm pulsed dye laser (PDL) treatment on the lesions, immediately followed by 3-month oral taking diindolylmethane (DIM, at 1.2-1.75mg/kg/day), in 15 subjects
1089703|NCT00591266|B4|Baseline|Total|Total of all reporting groups
1089704|NCT00591266|B3|Baseline|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089951|NCT00590759|E1|Reported Event|0502 TAG Device Subjects|
1089666|NCT00591578|E1|Reported Event|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.~Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
1089667|NCT00591565|B1|Baseline|Acamprosate|acamprosate tablets
1089668|NCT00591565|P1|Participant Flow|Acamprosate|acamprosate tablets
1089669|NCT00591565|O1|Outcome|Acamprosate|
1089670|NCT00591565|E1|Reported Event|Acamprosate|acamprosate tablets
1089671|NCT00591370|B1|Baseline|Temozolomide (TMZ)|Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
1089672|NCT00591370|P1|Participant Flow|Temozolomide (TMZ)|Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
1089673|NCT00591370|O1|Outcome|Temozolomide (TMZ)|Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
1089674|NCT00591370|O1|Outcome|Temozolomide (TMZ)|Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
1089675|NCT00591370|O1|Outcome|Temozolomide (TMZ)|Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
1089676|NCT00591370|E1|Reported Event|Temozolomide (TMZ)|Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
1089677|NCT00591344|B3|Baseline|Total|Total of all reporting groups
1089678|NCT00591344|B2|Baseline|2 Flexibility Training|"25 PD subjects performed between 60 and 90 minutes of flexibility training two times a week for two years at a local gym. These sessions were supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.~Exercise inlcuded flexibility training. Participants exercised twice a week for 2 years doing flexibility training."
1089679|NCT00591344|B1|Baseline|1 Progressive Resistance Training|"25 PD Subjects performed between 60 and 90 minutes of progressive resistance training two times a week for two years at a local gym. These sessions were supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.~Exercises included progressive resistance training. Participants exercised twice a week for 2 years doing progressive resistance training."
1089680|NCT00591344|P2|Participant Flow|2 Modified Fitness Counts|"Subjects performed between 60 and 90 minutes of flexibility training two times a week for two years at a local gym. These sessions were supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.~Exercise inlcuded flexibility training. Participants exercised twice a week for 2 years doing flexibility training."
1089681|NCT00591344|P1|Participant Flow|1 Progressive Resistance Training|"Subjects performed between 60 and 90 minutes of progressive resistance training two times a week for two years at a local gym. These sessions were supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.~Exercises included progressive resistance training. Participants exercised twice a week for 2 years doing progressive resistance training."
1089682|NCT00591344|O2|Outcome|Progressive Resistance Exercise|Baseline Assessment- L-dopa equilivent-mg/day
1089683|NCT00591344|O1|Outcome|Modified Fitness Counts|Baseline Assessment- L-dopa equilivent-mg/day
1089684|NCT00591344|O2|Outcome|Progressive Resistance Exercise|Baseline Assessment - on medication UPDRS part III, motor subscale score
1089685|NCT00591344|O1|Outcome|Modified Fitness Counts|Baseline Assessment- on medication UPDRS part III, motor subscale score
1089686|NCT00591344|O2|Outcome|Progressive Resistance Exercise|Baseline Assessment - off medication UPDRS part III, motor subscale score
1089687|NCT00591344|O1|Outcome|Modified Fitness Counts|Baseline Assessment- off medication UPDRS part III, motor subscale score
1089688|NCT00591344|E2|Reported Event|2 Modified Fitness Counts|"Subjects performed between 60 and 90 minutes of flexibility training two times a week for two years at a local gym. These sessions were supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.~Exercise inlcuded flexibility training. Participants exercised twice a week for 2 years doing flexibility training."
1089689|NCT00591344|E1|Reported Event|1 Progressive Resistance Training|"Subjects performed between 60 and 90 minutes of progressive resistance training two times a week for two years at a local gym. These sessions were supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.~Exercises included progressive resistance training. Participants exercised twice a week for 2 years doing progressive resistance training."
1089690|NCT00591305|B3|Baseline|Total|Total of all reporting groups
1089691|NCT00591305|B2|Baseline|PDL+Placebo Pill|"once-time PDL treatment on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects~585 nm pulsed dye laser: once-time PDL"
1089692|NCT00591305|B1|Baseline|PDL+DIM Pill|"once-time 585 nm pulsed dye laser (PDL) treatment on the lesions, immediately followed by 3-month oral taking diindolylmethane (DIM, at 1.2-1.75mg/kg/day), in 15 subjects~diindolylmethane (DIM): 3-month DIM~585 nm pulsed dye laser: once-time PDL"
1089693|NCT00591305|P2|Participant Flow|PDL+Placebo Pill|"once-time PDL treatment on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects~585 nm pulsed dye laser: once-time PDL"
1089694|NCT00591305|P1|Participant Flow|PDL+DIM Pill|"once-time 585 nm pulsed dye laser (PDL) treatment on the lesions, immediately followed by 3-month oral taking diindolylmethane (DIM, at 1.2-1.75mg/kg/day), in 15 subjects~diindolylmethane (DIM): 3-month DIM~585 nm pulsed dye laser: once-time PDL"
1089695|NCT00591305|O2|Outcome|Placebo|laser only without DIM
1089696|NCT00591305|O1|Outcome|Intervention|laser+diatary DIM
1089697|NCT00591305|O2|Outcome|Placebo|laser only without DIM
1089698|NCT00591305|O1|Outcome|Intervention|laser+diatary DIM
1089699|NCT00591305|O2|Outcome|Placebo|laser only without DIM
1089700|NCT00591305|O1|Outcome|Intervention|laser+dietary DIM
1089701|NCT00591305|E2|Reported Event|PDL+Placebo Pill|once-time PDL treatment by PDL on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects
1089705|NCT00591266|B2|Baseline|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089706|NCT00591266|B1|Baseline|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089707|NCT00591266|P3|Participant Flow|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089708|NCT00591266|P2|Participant Flow|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089709|NCT00591266|P1|Participant Flow|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089710|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089711|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089712|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089713|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089714|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089715|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089716|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089717|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089718|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089719|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089720|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089721|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089722|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089723|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089724|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089725|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089726|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089727|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089728|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089729|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089730|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089731|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089732|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089733|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089734|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089735|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089736|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089737|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089738|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089739|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089740|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089741|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089742|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089743|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089744|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089745|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089746|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089747|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089748|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089749|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089750|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089751|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089752|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089753|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089754|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089755|NCT00591266|E3|Reported Event|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089756|NCT00591266|E2|Reported Event|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089757|NCT00591266|E1|Reported Event|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
1089758|NCT00591253|B4|Baseline|Total|Total of all reporting groups
1089759|NCT00591253|B3|Baseline|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
1089760|NCT00591253|B2|Baseline|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1089761|NCT00591253|B1|Baseline|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1089762|NCT00591253|P3|Participant Flow|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
1089763|NCT00591253|P2|Participant Flow|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1089764|NCT00591253|P1|Participant Flow|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1089765|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
1089766|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1089767|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1089768|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
1089769|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1089770|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1089771|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
1089772|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1089773|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1089774|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
1089775|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1089776|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1089777|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
1089778|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1089779|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1089780|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
1089781|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1089782|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1089783|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
1089784|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1089785|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1089786|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
1089787|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1089788|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1089789|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
1089790|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1089791|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1089794|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1089795|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
1089796|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1089797|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1089798|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
1089799|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1089800|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1089801|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
1089802|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1089803|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1089804|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
1089805|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1089806|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1089807|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
1089808|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1089809|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1089810|NCT00591253|E3|Reported Event|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
1089811|NCT00591253|E2|Reported Event|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
1089812|NCT00591253|E1|Reported Event|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
1089813|NCT00591240|B3|Baseline|Total|Total of all reporting groups
1089814|NCT00591240|B2|Baseline|Antimicrobial Susceptibility Testing.|Urine samples of patients at risk of urinary tract infections were collected. Biosensor based antimicrobial susceptibility test, in concert with pathogen identification assay was directly performed on these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
1089815|NCT00591240|B1|Baseline|Multiplex Identification of Pathogens.|Urine samples of patients at risk for urinary tract infections were collected. Biosensor based assays were used to detect the most common uropathogens in these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
1089816|NCT00591240|P2|Participant Flow|Antimicrobial Susceptibility Testing.|Urine samples of patients at risk of urinary tract infections were collected. Biosensor based antimicrobial susceptibility test, in concert with pathogen identification assay was directly performed on these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
1089817|NCT00591240|P1|Participant Flow|Multiplex Identification of Pathogens.|Urine samples of patients at risk for urinary tract infections were collected. Biosensor based assays were used to detect the most common uropathogens in these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
1089818|NCT00591240|O2|Outcome|Antimicrobial Susceptibility Testing.|Urine samples of patients at risk of urinary tract infections were collected. Biosensor based antimicrobial susceptibility test, in concert with pathogen identification assay was directly performed on these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
1089819|NCT00591240|O1|Outcome|Multiplex Identification of Pathogens.|Urine samples of patients at risk for urinary tract infections were collected. Biosensor based assays were used to detect the most common uropathogens in these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
1089820|NCT00591240|E2|Reported Event|Antimicrobial Susceptibility Testing.|Urine samples of patients at risk of urinary tract infections were collected. Biosensor based antimicrobial susceptibility test, in concert with pathogen identification assay was directly performed on these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
1089821|NCT00591240|E1|Reported Event|Multiplex Identification of Pathogens.|Urine samples of patients at risk for urinary tract infections were collected. Biosensor based assays were used to detect the most common uropathogens in these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
1089822|NCT00591227|B3|Baseline|Total|Total of all reporting groups
1089823|NCT00591227|B2|Baseline|2 Usual Care|these subjects will receive no insulin per protocol during their ER stay or during a possible inpatient admission. The care for their diabetes will be solely determined by the physician(s) in the ER and by the physician(s) caring for them in the hospital if they are admitted. They may receive no therapy, oral agents or insulin per primary physician preference.
1089845|NCT00591019|P2|Participant Flow|Baseline, Placebo, Modafinil 200 mg/Day|Subjects are tested after baseline, then after taking a sugar pill once per day in the morning for 14 days, and then after taking modafinil 200 mg/day for 14 days.
1089954|NCT00590720|B1|Baseline|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
1205609|NCT00282672|O1|Outcome|All Groups|
1089824|NCT00591227|B1|Baseline|1-aspart Detemir|these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating.
1089825|NCT00591227|P2|Participant Flow|2 Usual Care|these subjects will receive no insulin per protocol during their ER stay or during a possible inpatient admission. The care for their diabetes will be solely determined by the physician(s) in the ER and by the physician(s) caring for them in the hospital if they are admitted. They may receive no therapy, oral agents or insulin per primary physician preference.
1089826|NCT00591227|P1|Participant Flow|1-aspart Detemir|these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating.
1089827|NCT00591227|O2|Outcome|2 Usual Care|these subjects will receive no insulin per protocol during their ER stay or during a possible inpatient admission. The care for their diabetes will be solely determined by the physician(s) in the ER and by the physician(s) caring for them in the hospital if they are admitted. They may receive no therapy, oral agents or insulin per primary physician preference.
1089828|NCT00591227|O1|Outcome|1-aspart Detemir|these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating.
1089829|NCT00591227|E2|Reported Event|2 Usual Care|these subjects will receive no insulin per protocol during their ER stay or during a possible inpatient admission. The care for their diabetes will be solely determined by the physician(s) in the ER and by the physician(s) caring for them in the hospital if they are admitted. They may receive no therapy, oral agents or insulin per primary physician preference.
1089830|NCT00591227|E1|Reported Event|1-aspart Detemir|these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating.
1089831|NCT00591214|B1|Baseline|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
1089832|NCT00591214|P1|Participant Flow|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
1089833|NCT00591214|O1|Outcome|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
1089834|NCT00591214|O1|Outcome|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
1089835|NCT00591214|O1|Outcome|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
1089836|NCT00591214|O1|Outcome|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
1089837|NCT00591214|O1|Outcome|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
1089838|NCT00591214|O1|Outcome|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
1089839|NCT00591214|E1|Reported Event|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
1089840|NCT00591149|B1|Baseline|Oxalipatin and Docetaxel|"Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity.~Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity.~Oxaliplatin: 130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles~Docetaxel: 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles~Cetuximab: 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks"
1089841|NCT00591149|P1|Participant Flow|Oxaliplatin and Docetaxel|"Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity.~Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity.~Docetaxel : 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles~Cetuximab : 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks~Oxaliplatin : 130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles"
1089842|NCT00591149|O1|Outcome|Oxaliplatin and Docetaxel|"Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity.~Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity.~Oxaliplatin: 130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles~Docetaxel: 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles~Cetuximab: 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks"
1089843|NCT00591149|E1|Reported Event|Oxaliplatin and Docetaxel|"Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity.~Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity.~Docetaxel : 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles~Cetuximab : 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks~Oxaliplatin : 130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles"
1089844|NCT00591019|B1|Baseline|All Participants|Subjects were tested at baseline, then entered either the modafinil or placebo condtion and then the remaining condition.
1089952|NCT00590720|B3|Baseline|Total|Total of all reporting groups
1089846|NCT00591019|P1|Participant Flow|Baseline, Modafinil 200 mg/Day, Placebo|Subjects are tested at baseline, then after Modafinil (200mg/day, a.m. administration) for 14 days, then after placebo (for 14 days).
1089847|NCT00591019|O3|Outcome|Placebo|Subjects are tested after taking a sugar pill once per day in the morning for 14 days.
1089848|NCT00591019|O2|Outcome|Modafinil|Subjects are tested after taking Modafinil (200mg/day, a.m. administration) for 14 days.
1089849|NCT00591019|O1|Outcome|Baseline Testing.|Establish baseline levels of performance
1089850|NCT00591019|O3|Outcome|Placebo|Subjects are tested after taking a sugar pill once per day in the morning for 14 days.
1089851|NCT00591019|O2|Outcome|Modafinil|Subjects are tested after taking Modafinil (200mg/day, a.m. administration) for 14 days.
1089852|NCT00591019|O1|Outcome|Baseline Testing.|Establish baseline levels of performance
1089853|NCT00591019|E3|Reported Event|Placebo|Subjects are tested after taking a sugar pill once per day in the morning for 14 days.
1089854|NCT00591019|E2|Reported Event|Modafinil|Subjects are tested after taking Modafinil (200mg/day, a.m. administration) for 14 days.
1089855|NCT00591019|E1|Reported Event|Baseline Testing.|Establish baseline levels of performance
1089856|NCT00591006|B1|Baseline|Total Study Population|Seventeen healthy controls, in a one-hour imaging session, received a structural MRI, MRS and fMRI scan four separate times with a 21 day washout between each study drug exposure in a crossover design. Prior to each scan each participant received placebo + placebo, phenytoin + placebo, hydrocortisone + placebo, or hydrocortisone + phenytoin in a random fashion. Thus, each participant received each of the four possible study drug combinations in a random order with an extended drug washout between each exposure. Hippocampal activation, volume and biochemistry, as well as mood and memory was assessed.
1089857|NCT00591006|P24|Participant Flow|PH + PL Then PL + H Then PL + PL Then PH + H|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400 mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours.
1089858|NCT00591006|P23|Participant Flow|PL + PL Then PH + H Then PL + H Then PH + PL|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by placebo. The imaging will be performed at 1300 hours.
1089859|NCT00591006|P22|Participant Flow|PL + PL Then PL + H Then PH + H Then PH + PL|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin (400mg/day) followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by placebo. The imaging will be performed at 1300 hours.
1089860|NCT00591006|P21|Participant Flow|PL + PL Then PL + H Then PH + PL Then PH + H|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin (400mg/day) followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours.
1089861|NCT00591006|P20|Participant Flow|PL + PL Then PH + H Then PH + PL Then PL + H|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours.
1089908|NCT00590967|O2|Outcome|Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)|"Para-Aortic Lymph Nodes Positive on FDG PET~IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)~IMRT external beam pelvic radiation therapy as appropriate for stage~Intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
1089953|NCT00590720|B2|Baseline|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
1089862|NCT00591006|P19|Participant Flow|PL + PL Then PH + PL Then PL + H Then PH + H|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours.
1089863|NCT00591006|P18|Participant Flow|PH + PL Then PH + H Then PL + H Then PL + PL|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by placebo. The imaging will be performed at 1300 hours.
1089864|NCT00591006|P17|Participant Flow|PH + PL Then PH + H Then PL + PL Then PL + H|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours.
1089865|NCT00591006|P16|Participant Flow|PH + PL Then PL + PL Then PL + H Then PH + H|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours.
1089866|NCT00591006|P15|Participant Flow|PH + PL Then PL + PL Then PH + H Then PL + H|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours.
1089867|NCT00591006|P14|Participant Flow|PH + H Then PL + PL Then PL + H Then PH + PL|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by placebo. The imaging will be performed at 1300 hours.
1089868|NCT00591006|P13|Participant Flow|PH + H Then PL + PL Then PH + PL Then PL + H|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours.
1089885|NCT00591006|O4|Outcome|PBO&Hydrocortisone|Participants will take two capsules containing placebo by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
1089869|NCT00591006|P12|Participant Flow|PH + H Then PH + PL Then PL + PL Then PL + H|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours.
1089870|NCT00591006|P11|Participant Flow|PH + H Then PL + H Then PH + PL Then PL + PL|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by hydrocortisone. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by placebo. The imaging will be performed at 1300 hours.
1089871|NCT00591006|P10|Participant Flow|PH + H Then PL + H Then PL + PL Then PH + PL|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by hydrocortisone. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by placebo. The imaging will be performed at 1300 hours.
1089872|NCT00591006|P9|Participant Flow|PL + H Then PH + PL Then PH + H Then PL + PL|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by placebo. The imaging will be performed at 1300 hours.
1089873|NCT00591006|P8|Participant Flow|PL + H Then PH + H Then PL + PL Then PH + PL|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by hydrocortisone. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by placebo. The imaging will be performed at 1300 hours.
1089874|NCT00591006|P7|Participant Flow|PL + H Then PH +H Then PH + PL Then PL + PL|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by hydrocortisone. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by placebo. The imaging will be performed at 1300 hours.
1089875|NCT00591006|P6|Participant Flow|PL + H Then PL + PL Then PH + H Then PH + PL|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin (400mg/day) followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by placebo. The imaging will be performed at 1300 hours.
1089886|NCT00591006|O3|Outcome|Phenytoin&PBO|Participants will take two capsules containing phenytoin tablets (100 mg) by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
1089876|NCT00591006|P5|Participant Flow|PL + H Then PH + PL Then PL + PL Then PH + H|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours.
1089877|NCT00591006|P4|Participant Flow|PL + H Then PL + PL Then PH + PL Then PH + H|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours (20mg) and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin (400mg/day) followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours.
1089878|NCT00591006|P3|Participant Flow|PL + PL Then PH + PL Then PH + H Then PL + H|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours.
1089879|NCT00591006|P2|Participant Flow|PH + H Then PH + PL Then PL + H Then PL + PL|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400 mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by placebo. The imaging will be performed at 1300 hours.
1089880|NCT00591006|P1|Participant Flow|PH + PL Then PL + H Then PL + H Then PL + PL|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400 mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets followed by hydrocortisone (160 mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by placebo. The imaging will be performed at 1300 hours.
1089881|NCT00591006|O4|Outcome|PBO&Hydrocortisone|Participants will take two capsules containing placebo by mouth at 0900 hours and 2100 hours for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
1089882|NCT00591006|O3|Outcome|Phenytoin&PBO|Participants will take two capsules containing phenytoin tablets (100 mg) by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
1089883|NCT00591006|O2|Outcome|PBO&PBO|Participants will take two capsules containing placebo by mouth at 0900 hours and 2100 hours for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
1089884|NCT00591006|O1|Outcome|Phenytoin&Hydrocortisone|Participants will take two capsules containing phenytoin tablets (100 mg) by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone (20 mg) also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
1089906|NCT00590967|O2|Outcome|Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)|"Para-Aortic Lymph Nodes Positive on FDG PET~IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)~IMRT external beam pelvic radiation therapy as appropriate for stage~Intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
1089887|NCT00591006|O2|Outcome|PBO&PBO|Participants will take two capsules containing placebo by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets of placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
1089888|NCT00591006|O1|Outcome|Phenytoin&Hydrocortisone|Participants will take two capsules containing phenytoin tablets (100 mg) by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone (20 mg) also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
1089889|NCT00591006|O4|Outcome|Placebo&Hydrocortisone|Examining all participants for the condition in which they took placebo and hydrocortisone.
1089890|NCT00591006|O3|Outcome|Phenytoin&Placebo|Examining all participants for the condition in which they took phenytoin and placebo.
1089891|NCT00591006|O2|Outcome|Placebo&Placebo|Examining all participants for the condition in which they took placebo for both administrations.
1089892|NCT00591006|O1|Outcome|Phenytoin&Hydrocortisone|Examining all participants for the condition in which they took both phenytoin and hydrocortisone.
1089893|NCT00591006|E4|Reported Event|Placebo, Then Placebo|"Hydrocortisone, Phenytoin~Phenytoin, Dilantin : participants will take two capsules containing phenytoin tablets (100 mg) or identical placebo by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin or placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) or placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours."
1089894|NCT00591006|E3|Reported Event|Placebo, Then Hydrocortisone|"Hydrocortisone, Placebo~Phenytoin, Dilantin : participants will take two capsules containing phenytoin tablets (100 mg) or identical placebo by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin or placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) or placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours."
1089895|NCT00591006|E2|Reported Event|Phenytoin, Then Placebo|"Phenytoin, Placebo~Phenytoin, Dilantin : participants will take two capsules containing phenytoin tablets (100 mg) or identical placebo by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin or placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) or placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours."
1089896|NCT00591006|E1|Reported Event|Phenytoin, Then Hydrocortisone|"Placebo, Placebo~Phenytoin, Dilantin : participants will take two capsules containing phenytoin tablets (100 mg) or identical placebo by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin or placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) or placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours."
1089897|NCT00590967|B3|Baseline|Total|Total of all reporting groups
1089898|NCT00590967|B2|Baseline|Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)|"Para-Aortic Lymph Nodes Positive on FDG PET~IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)~IMRT external beam pelvic radiation therapy as appropriate for stage~Intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
1089899|NCT00590967|B1|Baseline|Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)|"Pelvic Lymph Nodes Only Positive on FDG PET.~IMRT External Beam radiation to the para-aortic region (45 Gy)~Pelvis intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin 40 mg/m^2"
1089900|NCT00590967|P2|Participant Flow|Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)|"Para-Aortic Lymph Nodes Positive on FDG PET~IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)~IMRT external beam pelvic radiation therapy as appropriate for stage~Intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
1089901|NCT00590967|P1|Participant Flow|Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)|"Pelvic Lymph Nodes Only Positive on fluorodeoxyglucose (FDG) positron emission tomography (PET).~Intensity-modulated radiation therapy (IMRT) External Beam radiation to the para-aortic region (45 Gy)~Pelvis intracavitary brachytherapy (6 high dose radiation (HDR) treatments)~Weekly cisplatin 40 mg/m^2"
1089902|NCT00590967|O2|Outcome|Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)|"Para-Aortic Lymph Nodes Positive on FDG PET~IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)~IMRT external beam pelvic radiation therapy as appropriate for stage~Intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
1089903|NCT00590967|O1|Outcome|Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)|"Pelvic Lymph Nodes Only Positive on FDG PET.~IMRT External Beam radiation to the para-aortic region (45 Gy)~Pelvis intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
1089904|NCT00590967|O2|Outcome|Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)|"Para-Aortic Lymph Nodes Positive on FDG PET~IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)~IMRT external beam pelvic radiation therapy as appropriate for stage~Intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
1089905|NCT00590967|O1|Outcome|Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)|"Pelvic Lymph Nodes Only Positive on FDG PET.~IMRT External Beam radiation to the para-aortic region (45 Gy)~Pelvis intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
1089907|NCT00590967|O1|Outcome|Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)|"Pelvic Lymph Nodes Only Positive on FDG PET.~IMRT External Beam radiation to the para-aortic region (45 Gy)~Pelvis intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
1089909|NCT00590967|O1|Outcome|Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)|"Pelvic Lymph Nodes Only Positive on FDG PET.~IMRT External Beam radiation to the para-aortic region (45 Gy)~Pelvis intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
1089910|NCT00590967|E2|Reported Event|Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)|"Para-Aortic Lymph Nodes Positive on FDG PET~IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)~IMRT external beam pelvic radiation therapy as appropriate for stage~Intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
1089911|NCT00590967|E1|Reported Event|Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)|"Pelvic Lymph Nodes Only Positive on FDG PET.~IMRT External Beam radiation to the para-aortic region (45 Gy)~Pelvis intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
1089912|NCT00590902|B1|Baseline|1 - OSI-774|OSI-774: erlotinib, TarcevaTM: 150 mg, 100 mg and 25 mg tablets
1089913|NCT00590902|P1|Participant Flow|1 - OSI-774|OSI-774: erlotinib, TarcevaTM: 150 mg, 100 mg and 25 mg tablets
1089914|NCT00590902|O1|Outcome|1 - OSI-774|OSI-774: erlotinib, TarcevaTM: 150 mg, 100 mg and 25 mg tablets
1089915|NCT00590902|E1|Reported Event|1 - OSI-774|OSI-774: erlotinib, TarcevaTM: 150 mg, 100 mg and 25 mg tablets
1089916|NCT00590889|B3|Baseline|Total|Total of all reporting groups
1089917|NCT00590889|B2|Baseline|SJM Silzone|"SJM Masters Series Mechanical Heart Valve with Silzone Coating~Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling"
1089918|NCT00590889|B1|Baseline|SJM Conventional|"SJM Standard Masters Series Mechanical Heart Valve with Conventional Cuff~Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling"
1089919|NCT00590889|P2|Participant Flow|SJM Silzone|"SJM Masters Series Mechanical Heart Valve with Silzone Coating~Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling"
1089920|NCT00590889|P1|Participant Flow|SJM Conventional|"SJM Standard Masters Series Mechanical Heart Valve with Conventional Cuff~Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling"
1089921|NCT00590889|O2|Outcome|SJM Silzone|"SJM Masters Series Mechanical Heart Valve with Silzone Coating~Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling"
1089922|NCT00590889|O1|Outcome|SJM Conventional|"SJM Standard Masters Series Mechanical Heart Valve with Conventional Cuff~Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling"
1089923|NCT00590889|E2|Reported Event|Adverse Events for the Silzone™ Group|These patients received the Silzone™ treated heart valve.
1089924|NCT00590889|E1|Reported Event|Adverse Events for the Conventional Group|These patients received a conventional heart valve.
1089925|NCT00590863|B4|Baseline|Total|Total of all reporting groups
1089926|NCT00590863|B3|Baseline|Escitalopram + Placebo|Participants will take escitalopram (10 - 20 mg/day)+ placebo (1 to 3 pills per day). Medications taken orally. Participants will take escitalopram plus placebo for up to 28 weeks. Dosages were adjusted as need at each clinic visit.
1089927|NCT00590863|B2|Baseline|Venlafaxine XR + Mirtazapine|Participant takes Venlafaxine XR (75 to 225 mg/day) + Mirtazapine (15 to 45 mg/day) for up to 28 weeks. Medications taken orally. Venlafaxine XR was blinded, and mirtazapine was given open label. Dosages were adjusted as need at each clinic visit.
1089928|NCT00590863|B1|Baseline|Escitalopram + Bupropion SR|Participant takes Burpopion SR (150 to 450 mg/day)+ Escitalopram (10 to 20 mg/day) for up to 28 weeks. Medications taken orally. Bupropion SR was blinded, and escitalopram was given open label. Dosages were adjusted as need at each clinic visit.
1089929|NCT00590863|P3|Participant Flow|Escitalopram + Placebo|Participants will take escitalopram (10 - 20 mg/day)+ placebo (1 to 3 pills per day). Medications taken orally. Participants will take escitalopram plus placebo for up to 28 weeks. Dosages were adjusted as need at each clinic visit.
1089930|NCT00590863|P2|Participant Flow|Venlafaxine XR + Mirtazapine|Participant takes Venlafaxine XR (75 to 225 mg/day) + Mirtazapine (15 to 45 mg/day) for up to 28 weeks. Medications taken orally. Venlafaxine XR was blinded, and mirtazapine was given open label. Dosages were adjusted as need at each clinic visit.
1089931|NCT00590863|P1|Participant Flow|Escitalopram + Bupropion SR|Participant takes Burpopion SR (150 to 450 mg/day)+ Escitalopram (10 to 20 mg/day) for up to 28 weeks. Medications taken orally. Bupropion SR was blinded, and escitalopram was given open label. Dosages were adjusted as need at each clinic visit.
1089932|NCT00590863|O3|Outcome|Escitalopram + Placebo|"Participants will take escitalopram plus placebo.~Escitalopram + placebo : Participants will take escitalopram plus placebo for up to 28 weeks."
1089933|NCT00590863|O2|Outcome|Venlafaxine XR + Mirtazapine|Participants will take Venalfaxine XR + Mirtazapine for up to 28 weeks.
1089934|NCT00590863|O1|Outcome|Escitalopram + Bupropion SR|Participants will take Escitalopram + BurpopionSR for up to 28 weeks.
1089935|NCT00590863|O3|Outcome|Escitalopram + Placebo|"Participants will take escitalopram plus placebo.~Escitalopram + placebo : Participants will take escitalopram plus placebo for up to 28 weeks."
1089936|NCT00590863|O2|Outcome|Venlafaxine XR + Mirtazapine|Participants will take Venlafaine XR + Mirtazapine for up to 28 weeks.
1089937|NCT00590863|O1|Outcome|Escitalopram + Bupropion SR|Participants will take Escitalopram + BurpopionSR for up to 28 weeks.
1089938|NCT00590863|E3|Reported Event|Escitalopram + Placebo|Participants will take Escitalopram + Placebo for up to 28 weeks.
1089939|NCT00590863|E2|Reported Event|Venlafaxine XR + Mirtazapine|Participants will take Venlafaxine XR + Mirtazapine for up to 28 weeks.
1089940|NCT00590863|E1|Reported Event|Escitalopram + Bupropion SR|Participants will take Escitalopram + BurpopionSR for up to 28 weeks.
1089941|NCT00590772|B1|Baseline|Group 1|cross over
1089942|NCT00590772|P1|Participant Flow|Group 1|subjects were randomized to placebo or active drug and then cross over to opposite; however, the details of the randomization are no longer available.
1089943|NCT00590772|O2|Outcome|Placebo|
1089944|NCT00590772|O1|Outcome|Montelukast|
1089945|NCT00590772|E2|Reported Event|Placebo|
1089946|NCT00590772|E1|Reported Event|Montelukast|
1089947|NCT00590759|B1|Baseline|Thoracic Endograft|GORE TAG® Thoracic Endoprosthesis: implant
1089948|NCT00590759|P1|Participant Flow|Thoracic Endograft|GORE TAG® Thoracic Endoprosthesis: implant
1089955|NCT00590720|P2|Participant Flow|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
1089956|NCT00590720|P1|Participant Flow|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
1089957|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
1089958|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
1089959|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
1089960|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
1089961|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
1089962|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
1089963|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
1089964|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
1089965|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
1089966|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
1089967|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
1089968|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
1089969|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
1089970|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
1089971|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
1089972|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
1089973|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
1089974|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
1089975|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
1089976|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
1089977|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
1089978|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
1089979|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
1089980|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
1089981|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
1089982|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
1089983|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
1089984|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
1089985|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
1089986|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
1089987|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
1089988|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
1089989|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
1089990|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
1089991|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
1089992|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
1089993|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
1089994|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
1089995|NCT00590720|E2|Reported Event|MEDI528 50 mg|
1089996|NCT00590720|E1|Reported Event|PLACEBO|
1089997|NCT00590590|B4|Baseline|Total|Total of all reporting groups
1089998|NCT00590590|B3|Baseline|Placebo|Placebo administered twice weekly for 4 months
1089999|NCT00590590|B2|Baseline|Lidocaine|Lidocaine administered twice weekly for 4 months
1090000|NCT00590590|B1|Baseline|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
1090001|NCT00590590|P3|Participant Flow|Placebo|Placebo administered twice weekly for 4 months
1090002|NCT00590590|P2|Participant Flow|Lidocaine|Lidocaine administered twice weekly for 4 months
1090003|NCT00590590|P1|Participant Flow|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
1090004|NCT00590590|O3|Outcome|Placebo|Placebo administered twice weekly for 4 months
1090005|NCT00590590|O2|Outcome|Lidocaine|Lidocaine administered twice weekly for 4 months
1090006|NCT00590590|O1|Outcome|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
1090007|NCT00590590|O3|Outcome|Placebo|Placebo administered twice weekly for 4 months
1090008|NCT00590590|O2|Outcome|Lidocaine|Lidocaine administered twice weekly for 4 months
1090009|NCT00590590|O1|Outcome|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
1090010|NCT00590590|O3|Outcome|Placebo|Placebo administered twice weekly for 4 months
1090011|NCT00590590|O2|Outcome|Lidocaine|Lidocaine administered twice weekly for 4 months
1090012|NCT00590590|O1|Outcome|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
1090013|NCT00590590|O3|Outcome|Placebo|Placebo administered twice weekly for 4 months
1090014|NCT00590590|O2|Outcome|Lidocaine|Lidocaine administered twice weekly for 4 months
1090015|NCT00590590|O1|Outcome|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
1090016|NCT00590590|O3|Outcome|Placebo|Placebo administered twice weekly for 4 months
1090017|NCT00590590|O2|Outcome|Lidocaine|Lidocaine administered twice weekly for 4 months
1090018|NCT00590590|O1|Outcome|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
1090019|NCT00590590|O3|Outcome|Placebo|Placebo administered twice weekly for 4 months
1090020|NCT00590590|O2|Outcome|Lidocaine|Lidocaine administered twice weekly for 4 months
1090021|NCT00590590|O1|Outcome|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
1090022|NCT00590590|E3|Reported Event|Placebo|Placebo administered twice weekly for 4 months
1090023|NCT00590590|E2|Reported Event|Lidocaine|Lidocaine administered twice weekly for 4 months
1090024|NCT00590590|E1|Reported Event|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
1090025|NCT00590577|B5|Baseline|Total|Total of all reporting groups
1090026|NCT00590577|B4|Baseline|Placebo|Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
1090027|NCT00590577|B3|Baseline|Paliperidone Palmitate 150 mg eq.|Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
1090028|NCT00590577|B2|Baseline|Paliperidone Palmitate 100 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
1090029|NCT00590577|B1|Baseline|Paliperidone Palmitate 25 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
1090030|NCT00590577|P4|Participant Flow|Placebo|Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
1090031|NCT00590577|P3|Participant Flow|Paliperidone Palmitate 150 mg eq.|Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
1090032|NCT00590577|P2|Participant Flow|Paliperidone Palmitate 100 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
1090033|NCT00590577|P1|Participant Flow|Paliperidone Palmitate 25 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
1090034|NCT00590577|O4|Outcome|Placebo|Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
1090035|NCT00590577|O3|Outcome|Paliperidone Palmitate 150 mg eq.|Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
1090036|NCT00590577|O2|Outcome|Paliperidone Palmitate 100 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
1090037|NCT00590577|O1|Outcome|Paliperidone Palmitate 25 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
1090038|NCT00590577|O4|Outcome|Placebo|Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
1090039|NCT00590577|O3|Outcome|Paliperidone Palmitate 150 mg eq.|Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
1090040|NCT00590577|O2|Outcome|Paliperidone Palmitate 100 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
1090041|NCT00590577|O1|Outcome|Paliperidone Palmitate 25 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
1090042|NCT00590577|O4|Outcome|Placebo|Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
1090043|NCT00590577|O3|Outcome|Paliperidone Palmitate 150 mg eq.|Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
1090044|NCT00590577|O2|Outcome|Paliperidone Palmitate 100 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
1090045|NCT00590577|O1|Outcome|Paliperidone Palmitate 25 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
1090046|NCT00590577|E4|Reported Event|Placebo|Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
1090089|NCT00590369|O2|Outcome|Versatile One|Versatile One (EZCare)negative wound therapy device
1172365|NCT00381303|O7|Outcome|Other|
1091347|NCT00586157|B1|Baseline|Entire Study Population|
1090047|NCT00590577|E3|Reported Event|Paliperidone Palmitate 150 mg eq.|Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
1090048|NCT00590577|E2|Reported Event|Paliperidone Palmitate 100 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
1090049|NCT00590577|E1|Reported Event|Paliperidone Palmitate 25 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
1090050|NCT00590564|B1|Baseline|All Patients|Sho-saiko-to: All patients will receive treatment with 2.5grams of SST as granules in packet form by mouth three times a day every day for 52 weeks.
1090051|NCT00590564|P1|Participant Flow|All Patients|Sho-saiko-to: All patients will receive treatment with 2.5grams of SST as granules in packet form by mouth three times a day every day for 52 weeks.
1090052|NCT00590564|O1|Outcome|All Patients|Sho-saiko-to: All patients will receive treatment with 2.5grams of SST as granules in packet form by mouth three times a day every day for 52 weeks.
1090053|NCT00590564|E1|Reported Event|All Patients|Sho-saiko-to: All patients will receive treatment with 2.5grams of SST as granules in packet form by mouth three times a day every day for 52 weeks.
1090054|NCT00590538|B1|Baseline|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.~PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.~Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
1090055|NCT00590538|P1|Participant Flow|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.~PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.~Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
1090056|NCT00590538|O1|Outcome|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.~PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.~Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
1090057|NCT00590538|O1|Outcome|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.~PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.~Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
1090058|NCT00590538|O1|Outcome|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.~PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.~Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
1090059|NCT00590538|O1|Outcome|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.~PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.~Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
1090060|NCT00590538|O1|Outcome|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.~PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.~Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
1090061|NCT00590538|E1|Reported Event|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.~PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.~Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
1090062|NCT00590460|B1|Baseline|Group1|only one group
1090063|NCT00590460|P1|Participant Flow|Allogeneic Stem Cell Transplant|only one group
1090064|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|only one group
1090065|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|only one group
1090066|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|only one group
1090067|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|only one group
1090068|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|only one group
1090069|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|only one group
1090070|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|only one group
1090071|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|only one group
1090072|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|only one group
1090073|NCT00590460|E1|Reported Event|Group1|only one group
1090074|NCT00590369|B3|Baseline|Total|Total of all reporting groups
1090075|NCT00590369|B2|Baseline|Versatile One|Versatile One (EZCare)negative wound therapy device
1090076|NCT00590369|B1|Baseline|KCI VAC|KCI VAC type negative pressure wound therapy device
1090077|NCT00590369|P2|Participant Flow|Versatile One|Versatile One (EZCare)negative wound therapy device
1090078|NCT00590369|P1|Participant Flow|KCI VAC|KCI VAC type negative pressure wound therapy device
1090079|NCT00590369|O2|Outcome|Versatile One|Versatile One (EZCare)negative wound therapy device
1090080|NCT00590369|O1|Outcome|KCI VAC|KCI VAC type negative pressure wound therapy device
1090081|NCT00590369|O2|Outcome|Versatile One|Versatile One (EZCare)negative wound therapy device
1090082|NCT00590369|O1|Outcome|KCI VAC|KCI VAC type negative pressure wound therapy device
1090083|NCT00590369|O2|Outcome|Versatile One|Versatile One (EZCare)negative wound therapy device
1090084|NCT00590369|O1|Outcome|KCI VAC|KCI VAC type negative pressure wound therapy device
1090085|NCT00590369|O2|Outcome|Versatile One|Versatile One (EZCare)negative wound therapy device
1090086|NCT00590369|O1|Outcome|KCI VAC|KCI VAC type negative pressure wound therapy device
1090087|NCT00590369|O2|Outcome|Versatile One|Versatile One (EZCare)negative wound therapy device
1090088|NCT00590369|O1|Outcome|KCI VAC|KCI VAC type negative pressure wound therapy device
1090090|NCT00590369|O1|Outcome|KCI VAC|KCI VAC type negative pressure wound therapy device
1090091|NCT00590369|E2|Reported Event|Versatile One|Versatile One (EZCare)negative wound therapy device
1090092|NCT00590369|E1|Reported Event|KCI VAC|KCI VAC type negative pressure wound therapy device
1090093|NCT00590317|B3|Baseline|Total|Total of all reporting groups
1090094|NCT00590317|B2|Baseline|Ondansetron|Patients receiving Ondansetron 4 mg IV
1090095|NCT00590317|B1|Baseline|Prochlorperazine|Patients receiving Prochlorperazine 10 mg IV
1090096|NCT00590317|P2|Participant Flow|Ondansetron|Patients receiving Ondansetron 4mg IV
1090097|NCT00590317|P1|Participant Flow|Prochlorperazine|Patients receiving Prochlorperazine 10 mg IV
1090098|NCT00590317|O2|Outcome|Ondansetron|Patients receiving Ondansetron 4mg IV
1090099|NCT00590317|O1|Outcome|Prochlorperazine|Patients receiving Prochlorperazine 10 mg IV
1090100|NCT00590317|O2|Outcome|Ondansetron|Patients receiving Ondansetron 4mg IV
1090101|NCT00590317|O1|Outcome|Prochlorperazine|Patients receiving Prochlorperazine 10mg IV
1090102|NCT00590317|O2|Outcome|Ondansetron|Patients receiving Ondansetron 4mg IV
1090103|NCT00590317|O1|Outcome|Prochlorperazine|Patients receiving Prochlorperazine 10mg IV
1090104|NCT00590317|E2|Reported Event|Ondansetron|Patients receiving Ondansetron 4mg IV
1090105|NCT00590317|E1|Reported Event|Prochlorperazine|Patients receiving Prochlorperazine 10mg IV
1090106|NCT00590226|B3|Baseline|Total|Total of all reporting groups
1090107|NCT00590226|B2|Baseline|NPH+Regular|NPH insulin + regular insulin before breakfast and dinner
1090108|NCT00590226|B1|Baseline|Detemir + Aspart|Detemir insulin once daily + aspart insulin before meals
1090109|NCT00590226|P2|Participant Flow|NPH+Regular|NPH insulin + regular insulin before breakfast and dinner
1090110|NCT00590226|P1|Participant Flow|Detemir + Aspart|Detemir insulin once daily + aspart insulin before meals
1090111|NCT00590226|O2|Outcome|NPH+Regular|NPH insulin + regular insulin before breakfast and dinner
1090112|NCT00590226|O1|Outcome|Detemir + Aspart|Detemir insulin once daily + aspart insulin before meals
1090113|NCT00590226|O2|Outcome|NPH+Regular|NPH insulin + regular insulin before breakfast and dinner
1090114|NCT00590226|O1|Outcome|Detemir + Aspart|Detemir insulin once daily + aspart insulin before meals
1090115|NCT00590226|E2|Reported Event|NPH+Regular|NPH insulin + regular insulin before breakfast and dinner
1090116|NCT00590226|E1|Reported Event|Detemir + Aspart|Detemir insulin once daily + aspart insulin before meals
1090117|NCT00590161|B3|Baseline|Total|Total of all reporting groups
1090118|NCT00590161|B2|Baseline|Placebo TID|29 subjects received placebo as above for one year
1090119|NCT00590161|B1|Baseline|Pentoxifylline (PTX) 400 mg PO (by Mouth) TID|26 subjects received PTX at dose above for one year
1090120|NCT00590161|P2|Participant Flow|Placebo TID|29 subjects received placebo as above for one year
1090121|NCT00590161|P1|Participant Flow|Pentoxifylline (PTX) 400 mg PO Three Times Daily (TID)|26 subjects received PTX at dose above for one year
1090122|NCT00590161|O2|Outcome|Placebo Tid|29 subjects received placebo as above for one year
1090123|NCT00590161|O1|Outcome|Pentoxifylline 400 mg PO Tid|26 subjects received PTX at dose above for one year
1090124|NCT00590161|E2|Reported Event|Placebo Tid|29 subjects received placebo as above for one year
1090125|NCT00590161|E1|Reported Event|Pentoxifylline 400 mg PO Tid|26 subjects received PTX at dose above for one year
1090126|NCT00590044|B3|Baseline|Total|Total of all reporting groups
1090127|NCT00590044|B2|Baseline|NPH + Regular|Split-mixed NPH + Regular insulin twice daily
1090128|NCT00590044|B1|Baseline|Glargine (Lantus) + Glulisine|Daily insulin glargine (Lantus) + glulisine (Apidra) before meals
1090129|NCT00590044|P2|Participant Flow|NPH + Regular|Split-mixed NPH + Regular insulin twice daily
1090130|NCT00590044|P1|Participant Flow|Glargine (Lantus) + Glulisine|Daily insulin glargine (Lantus) + glulisine (Apidra) before meals
1090131|NCT00590044|O2|Outcome|NPH + Regular|Split-mixed NPH + Regular insulin twice daily
1090132|NCT00590044|O1|Outcome|Glargine (Lantus) + Glulisine|Daily insulin glargine (Lantus) + glulisine (Apidra) before meals
1090133|NCT00590044|E2|Reported Event|NPH + Regular|Split-mixed NPH + Regular insulin twice daily
1090134|NCT00590044|E1|Reported Event|Glargine (Lantus) + Glulisine|Daily insulin glargine (Lantus) + glulisine (Apidra) before meals
1090135|NCT00590031|B1|Baseline|Combined Modality Therapy for Esophageal Carcinoma|The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia.
1090136|NCT00590031|P1|Participant Flow|Combined Modality Therapy for Esophageal Carcinoma|The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia.
1090137|NCT00590031|O1|Outcome|Combined Modality Therapy for Esophageal Carcinoma|The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia.
1090272|NCT00589628|E1|Reported Event|5 mg/kg of Infliximab|5mg/kg/does of infliximab IV at 4 week intervals
1094160|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
1090138|NCT00590031|O1|Outcome|Combined Modality Therapy for Esophageal Carcinoma|The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia.
1090139|NCT00590031|E1|Reported Event|Combined Modality Therapy for Esophageal Carcinoma|The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia.
1090140|NCT00590018|B3|Baseline|Total|Total of all reporting groups
1090141|NCT00590018|B2|Baseline|Placebo|Subjects in this arm will receive 5 days of placebo. Placebo: Placebo for 5 days intravenously.
1090142|NCT00590018|B1|Baseline|Hydrocortisone|Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Hydrocortisone: Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
1090143|NCT00590018|P2|Participant Flow|Placebo|Subjects in this arm will receive 5 days of placebo. Placebo: Placebo for 5 days intravenously.
1090144|NCT00590018|P1|Participant Flow|Hydrocortisone|Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Hydrocortisone: Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
1090145|NCT00590018|O2|Outcome|Placebo|Subjects in this arm will receive 5 days of placebo. Placebo: Placebo for 5 days intravenously.
1090146|NCT00590018|O1|Outcome|Hydrocortisone|Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Hydrocortisone: Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
1090147|NCT00590018|O2|Outcome|Placebo|Subjects in this arm will receive 5 days of placebo. Placebo: Placebo for 5 days intravenously.
1090148|NCT00590018|O1|Outcome|Hydrocortisone|Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Hydrocortisone: Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
1090149|NCT00590018|E2|Reported Event|Placebo|Subjects in this arm will receive 5 days of placebo. Placebo: Placebo for 5 days intravenously.
1090150|NCT00590018|E1|Reported Event|Hydrocortisone|Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Hydrocortisone: Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
1090151|NCT00590005|B1|Baseline|Children With Asthma|The cohort consists of children with physician-diagnosed asthma across a wide range of severity (mild, moderate, severe)
1090152|NCT00590005|P2|Participant Flow|Children With Non-severe Asthma|This group includes child with physician-diagnosed asthma who did not meet criteria for severe asthma.
1090153|NCT00590005|P1|Participant Flow|Children With Severe Asthma|This group includes children with severe asthma diagnosed according to American Thoracic Society criteria (2000 workshop definition)
1090154|NCT00590005|O2|Outcome|Children With Non-severe Asthma|This group includes child with physician-diagnosed asthma who did not meet criteria for severe asthma.
1090155|NCT00590005|O1|Outcome|Children With Severe Asthma|This group includes children with severe asthma diagnosed according to American Thoracic Society criteria (2000 workshop definition)
1090156|NCT00590005|O2|Outcome|Children With Non-severe Asthma|This group includes child with physician-diagnosed asthma who did not meet criteria for severe asthma.
1090157|NCT00590005|O1|Outcome|Children With Severe Asthma|This group includes children with severe asthma diagnosed according to American Thoracic Society criteria (2000 workshop definition)
1090158|NCT00590005|E2|Reported Event|Children With Non-severe Asthma|This group includes child with physician-diagnosed asthma who did not meet criteria for severe asthma.
1090159|NCT00590005|E1|Reported Event|Children With Severe Asthma|This group includes children with severe asthma diagnosed according to American Thoracic Society criteria (2000 workshop definition)
1090160|NCT00589979|B3|Baseline|Total|Total of all reporting groups
1090161|NCT00589979|B2|Baseline|Sequence: Placebo - Lidoderm - Lidoderm|Matching placebo 10cm X 14cm patches each on the front and back of the index knee q24h for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks.
1090162|NCT00589979|B1|Baseline|Sequence: Lidoderm - Placebo - Placebo|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching placebo 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks.
1090163|NCT00589979|P3|Participant Flow|Treatment Sequence: Placebo - Lidoderm - Lidoderm|Matching placebo 10cm X 14cm patches each on the front and back of the index knee q24h for up to 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
1090164|NCT00589979|P2|Participant Flow|Treatment Sequence: Lidoderm - Placebo - Placebo|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for up to 4 weeks followed by matching placebo 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
1090165|NCT00589979|P1|Participant Flow|Run-in Period: Lidoderm|Run-in Period with patients applying Lidoderm (lidocaine 5% patch) 10cm x 14cm each on the front and back of the index knee every 24 hours for up to 28 days (4 weeks).
1090166|NCT00589979|O2|Outcome|Placebo Patch|The group represents the pooled data for all patients receiving placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
1090167|NCT00589979|O1|Outcome|Lidoderm (Lidocaine 5% Patch)|The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
1090219|NCT00589888|P1|Participant Flow|Normal Saline @ 40cc/Hour|"Normal Saline continuous IV infusion at 40cc/hour for 8 hours~0.9% Normal Saline: 0.9% Normal Saline continuous IV infusion at 40/cc for 8 hours"
1090168|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
1090169|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching placebo 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
1090170|NCT00589979|O2|Outcome|Placebo Patch|The group represents the pooled data for all patients receiving placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
1090171|NCT00589979|O1|Outcome|Lidoderm (Lidocaine 5% Patch)|The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
1090172|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
1090173|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
1090174|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
1090175|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
1090176|NCT00589979|O2|Outcome|Placebo Patch|The group represents the pooled data for all patients receiving placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
1090177|NCT00589979|O1|Outcome|Lidoderm (Lidocaine 5% Patch)|The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
1090178|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
1090179|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching placebo 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
1090180|NCT00589979|O2|Outcome|Placebo Patch|The group represents the pooled data for all patients receiving placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
1090181|NCT00589979|O1|Outcome|Lidoderm (Lidocaine 5% Patch)|The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
1090182|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
1090183|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
1090184|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
1090185|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
1090186|NCT00589979|O2|Outcome|Placebo Patch|The group represents the pooled data for all patients receiving placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
1090187|NCT00589979|O1|Outcome|Lidoderm (Lidocaine 5% Patch)|The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
1090188|NCT00589979|O2|Outcome|Placebo Patch|The group represents the pooled data for all patients receiving placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
1090189|NCT00589979|O1|Outcome|Lidoderm (Lidocaine 5% Patch)|The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
1090190|NCT00589979|O2|Outcome|Placebo Patch|The group represents the pooled data for all patients receiving Placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
1090191|NCT00589979|O1|Outcome|Lidoderm (Lidocaine 5% Patch)|The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
1090192|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
1090269|NCT00589628|O2|Outcome|Infliximab 10mg/kg|10mg/kg/dose of infliximab Iv at 4 week intervals
1090270|NCT00589628|O1|Outcome|Infliximab 5mg/kg|5mg/kg/does of infliximab IV at 4 week intervals
1090193|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
1090194|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
1090195|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (Lidocaine 5% Patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
1090196|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
1090197|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
1090198|NCT00589979|E3|Reported Event|Double-Blind Active Treatment Period With Placebo|"Treatment-Emergent Adverse Events (TEAEs) reported by subjects on Placebo during the Double-blind Treatment Period.~A treatment-emergent AE (TEAE) is any condition that was not present prior to treatment with study medication, but appeared following treatment, was present at treatment initiation, but worsened during treatment, or was present at treatment initiation, but resolved and then reappeared while the individual was on treatment (regardless of the intensity of the AE when the treatment was initiated).~**NOTE: two subjects randomized to the treatment sequence Lidoderm - Placebo - Placebo (PLL) discontinued from the study during treatment with Lidoderm (Period 1); therefore, the number of subjects included in the safety analysis by treatment group (Placebo) is equal to 91."
1090199|NCT00589979|E2|Reported Event|Double-Blind Treatment Period With Lidoderm|"Treatment-Emergent Adverse Events (TEAEs) reported by subjects on Lidoderm (lidocaine 5% patch) during the Double-blind Treatment Period.~A treatment-emergent AE (TEAE) is any condition that was not present prior to treatment with study medication, but appeared following treatment, was present at treatment initiation, but worsened during treatment, or was present at treatment initiation, but resolved and then reappeared while the individual was on treatment (regardless of the intensity of the AE when the treatment was initiated).~*NOTE: two subjects randomized to the treatment sequence Placebo - Lidoderm - Lidoderm (PLL) discontinued from the study during treatment with Placebo (Period 1); therefore, the number of subjects included in the safety analysis by treatment group (Lidoderm) is equal to 91."
1090200|NCT00589979|E1|Reported Event|Run-In Period With Lidoderm (Lidocaine 5% Patch)|"Treatment-Emergent Adverse Events (TEAEs) reported by subjects on Lidoderm (lidocaine 5% patch) during the active treatment Run-in Period.~A treatment-emergent AE (TEAE) is any condition that was not present prior to treatment with study medication, but appeared following treatment, was present at treatment initiation, but worsened during treatment, or was present at treatment initiation, but resolved and then reappeared while the individual was on treatment (regardless of the intensity of the AE when the treatment was initiated)."
1090201|NCT00589914|B3|Baseline|Total|Total of all reporting groups
1090202|NCT00589914|B2|Baseline|RISPERDAL CONSTA|Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
1090203|NCT00589914|B1|Baseline|R092670|Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
1090204|NCT00589914|P2|Participant Flow|RISPERDAL CONSTA|Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
1090205|NCT00589914|P1|Participant Flow|R092670|Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
1090206|NCT00589914|O2|Outcome|RISPERDAL CONSTA|Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
1090207|NCT00589914|O1|Outcome|R092670|Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
1090208|NCT00589914|O2|Outcome|RISPERDAL CONSTA|Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
1090209|NCT00589914|O1|Outcome|R092670|Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
1090210|NCT00589914|O2|Outcome|RISPERDAL CONSTA|Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
1090211|NCT00589914|O1|Outcome|R092670|Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
1090212|NCT00589914|E2|Reported Event|RISPERDAL CONSTA|Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
1090213|NCT00589914|E1|Reported Event|R092670|Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
1090214|NCT00589888|B1|Baseline|All Study Participants|"All participants received all 5 arms in random order:~0.9% Normal Saline continuous IV infusion at 40/cc for 8 hours~Intralipid 20% @ 20cc/hr for 8 hours~Intralipid 20% @ 40cc/Hr for 8 hours~32-gram Oral Fat Load every 2 hours for 8 hours.~64-gram Oral Fat Loadevery 2 hours for 8 hours."
1090215|NCT00589888|P5|Participant Flow|64-gram Oral Fat Load|"64-gram oral fat load~64-gram oral fat load: 60-gram oral fat load intake every 2 hours for 8 hours"
1090216|NCT00589888|P4|Participant Flow|32-gram Oral Fat Load|"32-gram oral fat load~32-gram oral fat load: oral liquid fat load prepared by the GCRC every 2 hours for 8 hours."
1090217|NCT00589888|P3|Participant Flow|Intralipid 20% @ 40cc/Hour|"Intralipid 20% IV infusion at 40cc/hour~Intralipid 20%: Intralipid 20% IV continuous infusion at 40cc/hour for 8 hours"
1090218|NCT00589888|P2|Participant Flow|Intralipid 20% @ 20cc/hr|"Intralipid 20% IV infusion at 20cc/hour~Intralipid 20%: Intralipid 20% IV continuous infusion at 20cc/hour for 8 hours"
1090271|NCT00589628|E2|Reported Event|10 mg/kg of Infliximab|10mg/kg/dose of infliximab Iv at 4 week intervals
1090220|NCT00589888|O1|Outcome|Oral 64-gram Fat Load|For the high (64 g fat) oral fat load studies, participants received fat with FFA composed of 33% polyunsaturated fatty acids, 34% monounsaturated fatty acids, and 22% saturated fatty acids. The oral fat load in either low or high dose was given in four equally divided doses at 0, 2, 4, and 6 h.
1090221|NCT00589888|O1|Outcome|Oral 32-gram Fat Load|For the low (32 g fat) oral fat load studies, participants received fat with FFA composed of 33% polyunsaturated fatty acids, 34% monounsaturated fatty acids, and 22% saturated fatty acids. The oral fat load in either low or high dose was given in four equally divided doses at 0, 2, 4, and 6 h.
1090222|NCT00589888|O1|Outcome|Intralipid @ 20cc/Hour|Intralipid continuous IV infusion at 20cc/hour for 8 hours
1090223|NCT00589888|O1|Outcome|Intralipid @ 20cc/Hour|Intralipid continuous IV infusion at 20cc/hour for 8 hours
1090224|NCT00589888|O1|Outcome|Normal Saline @ 40cc/Hour|"Normal Saline continuous IV infusion at 40cc/hour for 8 hours~0.9% Normal Saline: 0.9% Normal Saline continuous IV infusion at 40/cc for 8 hours"
1090225|NCT00589888|E5|Reported Event|64-gram Oral Fat Load|"64-gram oral fat load~64-gram oral fat load: 60-gram oral fat load intake every 2 hours for 8 hours"
1090226|NCT00589888|E4|Reported Event|32-gram Oral Fat Load|"32-gram oral fat load~32-gram oral fat load: oral liquid fat load prepared by the GCRC every 2 hours for 8 hours."
1090227|NCT00589888|E3|Reported Event|Intralipid 20% @ 40cc/Hour|"Intralipid 20% IV infusion at 40cc/hour~Intralipid 20%: Intralipid 20% IV continuous infusion at 40cc/hour for 8 hours"
1090228|NCT00589888|E2|Reported Event|Intralipid 20% @ 20cc/hr|"Intralipid 20% IV infusion at 20cc/hour~Intralipid 20%: Intralipid 20% IV continuous infusion at 20cc/hour for 8 hours"
1090229|NCT00589888|E1|Reported Event|Normal Saline @ 40cc/Hour|"Normal Saline continuous IV infusion at 40cc/hour for 8 hours~0.9% Normal Saline: 0.9% Normal Saline continuous IV infusion at 40/cc for 8 hours"
1090230|NCT00589849|B1|Baseline|T Wave Altenans Stress Test|
1090231|NCT00589849|P1|Participant Flow|T Wave Altenans Stress Test|
1090232|NCT00589849|O1|Outcome|T Wave Altenans Stress Test|
1090233|NCT00589849|E1|Reported Event|T Wave Altenans Stress Test|
1090234|NCT00589784|B3|Baseline|Total|Total of all reporting groups
1090235|NCT00589784|B2|Baseline|Exploratory Cohort|Patients with WHO grade I meningioma, HPC and hemangioblastoma
1090236|NCT00589784|B1|Baseline|Aggressive Memingioma|Patients with Aggressive Memingioma
1090237|NCT00589784|P2|Participant Flow|Exploratory Cohort|Patients with WHO grade I meningioma, HPC and hemangioblastoma
1090238|NCT00589784|P1|Participant Flow|Aggressive Memingioma|Patients with Aggressive Memingioma
1090239|NCT00589784|O2|Outcome|Exploratory Cohort|Patients with WHO grade I meningioma, HPC and hemangioblastoma
1090240|NCT00589784|O1|Outcome|Aggressive Memingioma|Patients with Aggressive Memingioma
1090241|NCT00589784|E1|Reported Event|All Patients|All patients treated with Sunitinib (SU011248)
1090242|NCT00589693|B3|Baseline|Total|Total of all reporting groups
1090243|NCT00589693|B2|Baseline|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
1090244|NCT00589693|B1|Baseline|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
1090245|NCT00589693|P2|Participant Flow|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
1090246|NCT00589693|P1|Participant Flow|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
1090247|NCT00589693|O2|Outcome|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
1090248|NCT00589693|O1|Outcome|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
1090249|NCT00589693|O2|Outcome|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
1090250|NCT00589693|O1|Outcome|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
1090251|NCT00589693|O2|Outcome|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
1090252|NCT00589693|O1|Outcome|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
1090253|NCT00589693|O2|Outcome|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
1090254|NCT00589693|O1|Outcome|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
1090255|NCT00589693|O2|Outcome|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
1090256|NCT00589693|O1|Outcome|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
1090257|NCT00589693|E2|Reported Event|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
1090258|NCT00589693|E1|Reported Event|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
1090259|NCT00589667|B1|Baseline|Pemetrexed Plus Gemcitabine|Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
1090260|NCT00589667|P1|Participant Flow|Pemetrexed Plus Gemcitabine|Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
1090261|NCT00589667|O1|Outcome|Pemetrexed Plus Gemcitabine|Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
1090262|NCT00589667|O1|Outcome|Pemetrexed Plus Gemcitabine|Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
1090263|NCT00589667|E1|Reported Event|Pemetrexed Plus Gemcitabine|Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
1090264|NCT00589628|B3|Baseline|Total|Total of all reporting groups
1090265|NCT00589628|B2|Baseline|10 mg/kg of Infliximab|10mg/kg/dose of infliximab Iv at 4 week intervals
1090266|NCT00589628|B1|Baseline|5 mg/kg of Infliximab|5mg/kg/does of infliximab IV at 4 week intervals
1090267|NCT00589628|P2|Participant Flow|Infliximab 10 mg/kg|10mg/kg/dose of infliximab Iv at 4 week intervals
1090268|NCT00589628|P1|Participant Flow|Infliximab 5 mg/kg|5mg/kg/does of infliximab IV at 4 week intervals
1090273|NCT00589602|B1|Baseline|T-Cell Depletion Transplant|"Our protocol is designed to attempt to improve the current results of MUD allo BMT and will be a major step towards the introduction and refinement of graft engineering. Our approach will address in a rational fashion all major technical and clinical aspects of MUD allo BMT.~Peripheral blood lymphocyte therapy; cyclophosphamide, tacrolimus, peripheral blood stem cell transplantation; total-body irradiation; 'allogeneic hematopoietic stem cell transplantation'~peripheral blood lymphocyte therapy: T-cell depletion~cyclophosphamide: T-cell depletion~tacrolimus: T-cell depletion~allogeneic hematopoietic stem cell transplantation: T-cell depletion~peripheral blood stem cell transplantation: T-cell depletion~total-body irradiation: T-cell depletion"
1090274|NCT00589602|P1|Participant Flow|T-Cell Depletion Transplant|"Our protocol is designed to attempt to improve the current results of MUD allo BMT and will be a major step towards the introduction and refinement of graft engineering. Our approach will address in a rational fashion all major technical and clinical aspects of MUD allo BMT.~Peripheral blood lymphocyte therapy; cyclophosphamide, tacrolimus, peripheral blood stem cell transplantation; total-body irradiation; 'allogeneic hematopoietic stem cell transplantation'~peripheral blood lymphocyte therapy: T-cell depletion~cyclophosphamide: T-cell depletion~tacrolimus: T-cell depletion~allogeneic hematopoietic stem cell transplantation: T-cell depletion~peripheral blood stem cell transplantation: T-cell depletion~total-body irradiation: T-cell depletion"
1090275|NCT00589602|O1|Outcome|T-Cell Depletion Transplant|"peripheral blood lymphocyte therapy: T-cell depletion will be accomplished using CD34 selection with the Baxter Isolex 300i v. 2.5 device. The desirable T-cell dose will be >0.5 x 105 but <1.0 x 105 CD3+ cells per kg. The targeted CD34 cell dose will be >2 x 106 cells/kg.~cyclophosphamide: Cyclophosphamide 60 mg/kg/d for 2 days on Day –5 and Day –4~tacrolimus: tacrolimus on day -1 administered by continuous IV infusion over 24 hours~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~total-body irradiation (TBI): Treatment will be delivered using 6MV photons twice daily for 3 days"
1090276|NCT00589602|O1|Outcome|T-Cell Depletion Transplant|"peripheral blood lymphocyte therapy: T-cell depletion will be accomplished using CD34 selection with the Baxter Isolex 300i v. 2.5 device. The desirable T-cell dose will be >0.5 x 105 but <1.0 x 105 CD3+ cells per kg. The targeted CD34 cell dose will be >2 x 106 cells/kg.~cyclophosphamide: Cyclophosphamide 60 mg/kg/d for 2 days on Day –5 and Day –4~tacrolimus: tacrolimus on day -1 administered by continuous IV infusion over 24 hours~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~total-body irradiation (TBI): Treatment will be delivered using 6MV photons twice daily for 3 days"
1090277|NCT00589602|O1|Outcome|T-Cell Depletion Transplant|"peripheral blood lymphocyte therapy: T-cell depletion will be accomplished using CD34 selection with the Baxter Isolex 300i v. 2.5 device. The desirable T-cell dose will be >0.5 x 105 but <1.0 x 105 CD3+ cells per kg. The targeted CD34 cell dose will be >2 x 106 cells/kg.~cyclophosphamide: Cyclophosphamide 60 mg/kg/d for 2 days on Day –5 and Day –4~tacrolimus: tacrolimus on day -1 administered by continuous IV infusion over 24 hours~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~total-body irradiation (TBI): Treatment will be delivered using 6MV photons twice daily for 3 days"
1090278|NCT00589602|O1|Outcome|T-Cell Depletion Transplant|"Our protocol is designed to attempt to improve the current results of matched unrelated donor allogeneic bone marrow transplant (MUD allo BMT) and will be a major step towards the introduction and refinement of graft engineering. Our approach will address in a rational fashion all major technical and clinical aspects of MUD allo BMT.~Peripheral blood lymphocyte therapy; cyclophosphamide, tacrolimus, peripheral blood stem cell transplantation; total-body irradiation; allogeneic hematopoietic stem cell transplantation;~peripheral blood lymphocyte therapy: T-cell depletion~cyclophosphamide: T-cell depletion~tacrolimus: T-cell depletion~allogeneic hematopoietic stem cell transplantation: T-cell depletion~peripheral blood stem cell transplantation: T-cell depletion~total-body irradiation: T-cell depletion"
1090279|NCT00589602|O1|Outcome|T-Cell Depletion Transplant|"Our protocol is designed to attempt to improve the current results of MUD allo BMT and will be a major step towards the introduction and refinement of graft engineering. Our approach will address in a rational fashion all major technical and clinical aspects of MUD allo BMT.~Peripheral blood lymphocyte therapy; cyclophosphamide, tacrolimus, peripheral blood stem cell transplantation; total-body irradiation; 'allogeneic hematopoietic stem cell transplantation'~peripheral blood lymphocyte therapy: T-cell depletion~cyclophosphamide: T-cell depletion~tacrolimus: T-cell depletion~allogeneic hematopoietic stem cell transplantation: T-cell depletion~peripheral blood stem cell transplantation: T-cell depletion~total-body irradiation: T-cell depletion"
1090280|NCT00589602|E1|Reported Event|T-Cell Depletion Transplant|"peripheral blood lymphocyte therapy: T-cell depletion~cyclophosphamide: T-cell depletion~tacrolimus: T-cell depletion~allogeneic hematopoietic stem cell transplantation: T-cell depletion~peripheral blood stem cell transplantation: T-cell depletion~total-body irradiation: T-cell depletion"
1090281|NCT00589563|B1|Baseline|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
1090282|NCT00589563|P1|Participant Flow|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
1090283|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
1090284|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
1090285|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
1090286|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
1090287|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
1090288|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
1090289|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
1090290|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
1090291|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
1090292|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
1172366|NCT00381303|O6|Outcome|Asian|
1090293|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
1090294|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
1090295|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
1090296|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
1090297|NCT00589563|E1|Reported Event|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done. One patient did not have adverse event data collected.
1090298|NCT00589550|B1|Baseline|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
1090299|NCT00589550|P1|Participant Flow|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
1090300|NCT00589550|O1|Outcome|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
1090301|NCT00589550|O1|Outcome|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
1090302|NCT00589550|O1|Outcome|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
1090303|NCT00589550|O1|Outcome|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
1090304|NCT00589550|O1|Outcome|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
1090305|NCT00589550|O1|Outcome|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
1090306|NCT00589550|O1|Outcome|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
1090348|NCT00589108|O3|Outcome|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
1090349|NCT00589108|O2|Outcome|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
1090350|NCT00589108|O1|Outcome|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
1090307|NCT00589550|E1|Reported Event|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
1090308|NCT00589303|B3|Baseline|Total|Total of all reporting groups
1090309|NCT00589303|B2|Baseline|Atrioventricular Node (AVN) Ablation / Pacing|Atrioventricular Node ablation and device implant
1090310|NCT00589303|B1|Baseline|Drug Therapy|FDA approved rate and rhythm control drugs
1090311|NCT00589303|P2|Participant Flow|Atrioventricular Node (AVN) Ablation / Pacing|Atrioventricular Node ablation and device implant
1090312|NCT00589303|P1|Participant Flow|Drug Therapy|FDA approved rate and rhythm control drugs
1090313|NCT00589303|O2|Outcome|Atrioventricular Node (AVN) Ablation / Pacing|Atrioventricular Node ablation and device implant
1090314|NCT00589303|O1|Outcome|Drug Therapy|FDA approved rate and rhythm control drugs
1090315|NCT00589303|E2|Reported Event|Atrioventricular Node (AVN) Ablation / Pacing|Atrioventricular Node ablation and device implant
1090316|NCT00589303|E1|Reported Event|Drug Therapy|FDA approved rate and rhythm control drugs
1090317|NCT00589290|B1|Baseline|Belinostat Treatment|1000 mg/m^2/day as a 30 minute intravenous (IV) infusion daily for 5 days every 3 weeks (day 1-5 of the 3 week treatment cycle). After 12 cycles of treatment, cycles will be given for 5 days every 4 weeks.
1090318|NCT00589290|P1|Participant Flow|Belinostat Treatment|1000 mg/m^2/day as a 30 minute intravenous (IV) infusion daily for 5 days every 3 weeks (day 1-5 of the 3 week treatment cycle). After 12 cycles of treatment, cycles will be given for 5 days every 4 weeks.
1090319|NCT00589290|O2|Outcome|Thymic Patients|Poorly differentiated neoplasm
1090320|NCT00589290|O1|Outcome|Thymoma Patients|Well differentiated neoplasm
1090321|NCT00589290|O1|Outcome|Belinostat|1000 mg/m^2 day, 30 minute intravenous infusion daily for 5 days every 3 weeks (day 1-5 of the 3 week treatment cycle). After 12 cycles of treatment, cycles will be given for 5 days every 4 weeks.
1090322|NCT00589290|O2|Outcome|Thymic Patients|Poorly differentiated neoplasm
1090323|NCT00589290|O1|Outcome|Thymoma Patients|Well differentiated neoplasm
1090324|NCT00589290|E1|Reported Event|Belinostat Treatment|1000 mg/m^2/day as a 30 minute intravenous (IV) infusion daily for 5 days every 3 weeks (day 1-5 of the 3 week treatment cycle). After 12 cycles of treatment, cycles will be given for 5 days every 4 weeks.
1090325|NCT00589277|B3|Baseline|Total|Total of all reporting groups
1090326|NCT00589277|B2|Baseline|Gain-Framed Counseling|Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.
1090327|NCT00589277|B1|Baseline|Standard Care Counseling|Standard care counseling + standard care print information
1090328|NCT00589277|P2|Participant Flow|Gain-Framed Counseling|Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.
1090329|NCT00589277|P1|Participant Flow|Standard Care Counseling|Standard care counseling + standard care print information
1090330|NCT00589277|O2|Outcome|Gain-Framed Counseling|Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.
1090331|NCT00589277|O1|Outcome|Standard Care Counseling|Standard care counseling + standard care print information
1090332|NCT00589277|O2|Outcome|Gain-Framed Counseling|Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.
1090333|NCT00589277|O1|Outcome|Standard Care Counseling|Standard care counseling + standard care print information
1090334|NCT00589277|O2|Outcome|Gain-Framed Counseling|Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.
1090335|NCT00589277|O1|Outcome|Standard Care Counseling|Standard care counseling + standard care print information
1090336|NCT00589277|E2|Reported Event|Gain-Framed Counseling|Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.
1090337|NCT00589277|E1|Reported Event|Standard Care Counseling|Standard care counseling + standard care print information
1090338|NCT00589108|B4|Baseline|Total|Total of all reporting groups
1090339|NCT00589108|B3|Baseline|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
1090340|NCT00589108|B2|Baseline|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
1090341|NCT00589108|B1|Baseline|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
1090342|NCT00589108|P3|Participant Flow|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
1090343|NCT00589108|P2|Participant Flow|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
1090344|NCT00589108|P1|Participant Flow|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
1090345|NCT00589108|O3|Outcome|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
1090346|NCT00589108|O2|Outcome|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
1090347|NCT00589108|O1|Outcome|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
1090351|NCT00589108|O3|Outcome|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
1090352|NCT00589108|O2|Outcome|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
1090353|NCT00589108|O1|Outcome|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
1090354|NCT00589108|O3|Outcome|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
1090355|NCT00589108|O2|Outcome|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
1090356|NCT00589108|O1|Outcome|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
1090357|NCT00589108|O3|Outcome|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
1090358|NCT00589108|O2|Outcome|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
1090359|NCT00589108|O1|Outcome|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
1090360|NCT00589108|E3|Reported Event|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
1090361|NCT00589108|E2|Reported Event|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
1090362|NCT00589108|E1|Reported Event|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
1090363|NCT00588237|B1|Baseline|All Patients|Paclitaxel, Cisplatin, Bevacizumab
1090364|NCT00588237|P1|Participant Flow|All Patients|Paclitaxel, Cisplatin, Bevacizumab
1090365|NCT00588237|O1|Outcome|All Patients|Paclitaxel, Cisplatin, Bevacizumab
1090366|NCT00588237|E1|Reported Event|All Patients|Paclitaxel, Cisplatin, Bevacizumab
1090367|NCT00588965|B1|Baseline|All Subjects|Subjects will take propranolol LA 80 mg or placebo daily for one week then propranolol LA 160 mg for one week or 2 placebo pills, followed by the exercise test. The participants will be randomized to one of 2 sequences: placebo first or propranolol first.
1090368|NCT00588965|P1|Participant Flow|All Participants|All participants were randomized to one of 2 sequences, in which they received either propranolol first, then placebo, or placebo first, then propranolol.
1090369|NCT00588965|O2|Outcome|Propranolol|
1090370|NCT00588965|O1|Outcome|Placebo|
1090371|NCT00588965|O2|Outcome|Propranolol|
1090372|NCT00588965|O1|Outcome|Placebo|
1090373|NCT00588965|E2|Reported Event|Propranolol|Subjects will take propranolol LA 80 mg daily for one week then 160 mg for one week followed by the exercise test.
1090374|NCT00588965|E1|Reported Event|Placebo|Subjects are assigned to placebo.
1090375|NCT00588952|B3|Baseline|Total|Total of all reporting groups
1090376|NCT00588952|B2|Baseline|Family History Negative|"Subjects with a negative family history of alcoholism~Ketamine and Placebo: Two test days will involve administration of placebo and Ketamine (0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute) intravenously for 60 minutes"
1090377|NCT00588952|B1|Baseline|Family History Positive|"Subjects with a positive family history of alcoholism~Ketamine and Placebo: Two test days will involve administration of placebo and Ketamine (0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute) intravenously for 60 minutes"
1090378|NCT00588952|P2|Participant Flow|Family History Negative|"Subjects with a negative family history of alcoholism~Ketamine and Placebo: Two test days will involve administration of placebo and Ketamine (0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute) intravenously for 60 minutes"
1090379|NCT00588952|P1|Participant Flow|Family History Positive|"Subjects with a positive family history of alcoholism~Ketamine and Placebo: Two test days will involve administration of placebo and Ketamine (0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute) intravenously for 60 minutes"
1090380|NCT00588952|O2|Outcome|Family History Negative|"Subjects with a negative family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
1090381|NCT00588952|O1|Outcome|Family History Positive|"Subjects with a positive family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
1090382|NCT00588952|O2|Outcome|Family History Negative|"Subjects with a negative family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
1090383|NCT00588952|O1|Outcome|Family History Positive|"Subjects with a positive family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
1090384|NCT00588952|O2|Outcome|Family History Negative|"Subjects with a negative family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
1090385|NCT00588952|O1|Outcome|Family History Positive|"Subjects with a positive family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
1090386|NCT00588952|O2|Outcome|Family History Negative|"Subjects with a negative family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
1090387|NCT00588952|O1|Outcome|Family History Positive|"Subjects with a positive family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
1090388|NCT00588952|O2|Outcome|Family History Negative|"Subjects with a negative family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
1094447|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
1090389|NCT00588952|O1|Outcome|Family History Positive|"Subjects with a positive family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
1090390|NCT00588952|O2|Outcome|Family History Negative|"Subjects with a negative family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
1090391|NCT00588952|O1|Outcome|Family History Positive|"Subjects with a positive family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
1090392|NCT00588952|O2|Outcome|Family History Negative|"Subjects with a negative family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
1090393|NCT00588952|O1|Outcome|Family History Positive|"Subjects with a positive family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
1090394|NCT00588952|O2|Outcome|Family History Negative|"Subjects with a negative family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
1090395|NCT00588952|O1|Outcome|Family History Positive|"Subjects with a positive family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
1090396|NCT00588952|E2|Reported Event|Family History Negative|"Subjects with a negative family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
1090397|NCT00588952|E1|Reported Event|Family History Positive|"Subjects with a positive family history of alcoholism~Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV~Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution"
1090398|NCT00588900|B1|Baseline|Irinotecan + Cediranib|Participants receive irinotecan hydrochloride 125 mg/m^2 IV over 90 minutes on days 1 and 8 and oral cediranib 20 mg once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
1090399|NCT00588900|P1|Participant Flow|Irinotecan + Cediranib|Participants receive irinotecan hydrochloride 125 mg/m^2 IV over 90 minutes on days 1 and 8 and oral cediranib 20 mg once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
1090400|NCT00588900|O1|Outcome|Irinotecan + Cediranib|Participants receive irinotecan hydrochloride 125 mg/m^2 IV over 90 minutes on days 1 and 8 and oral cediranib 20 mg once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
1090401|NCT00588900|O1|Outcome|Irinotecan + Cediranib|Participants receive irinotecan hydrochloride 125 mg/m^2 IV over 90 minutes on days 1 and 8 and oral cediranib 20 mg once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
1090402|NCT00588900|O1|Outcome|Irinotecan + Cediranib|Participants receive irinotecan hydrochloride 125 mg/m^2 IV over 90 minutes on days 1 and 8 and oral cediranib 20 mg once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
1090403|NCT00588900|E1|Reported Event|Irinotecan + Cediranib|Participants receive irinotecan hydrochloride 125 mg/m^2 IV over 90 minutes on days 1 and 8 and oral cediranib 20 mg once daily on days 1-21. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
1090404|NCT00588861|B3|Baseline|Total|Total of all reporting groups
1090405|NCT00588861|B2|Baseline|Answer Stem Utilizing Palacos Cement|Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
1090406|NCT00588861|B1|Baseline|Answer Stem Utilizing Simplex Cement|Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
1090407|NCT00588861|P2|Participant Flow|Answer Stem Utilizing Palacos Cement|Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
1090408|NCT00588861|P1|Participant Flow|Answer Stem Utilizing Simplex Cement|Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
1090409|NCT00588861|O2|Outcome|Answer Stem Utilizing Palacos Cement|Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
1090410|NCT00588861|O1|Outcome|Answer Stem Utilizing Simplex Cement|Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
1090411|NCT00588861|O2|Outcome|Answer Stem Utilizing Palacos Cement|Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
1090412|NCT00588861|O1|Outcome|Answer Stem Utilizing Simplex Cement|Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
1090413|NCT00588861|E2|Reported Event|Answer Stem Utilizing Palacos Cement|Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
1090414|NCT00588861|E1|Reported Event|Answer Stem Utilizing Simplex Cement|Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
1090415|NCT00588848|B3|Baseline|Total|Total of all reporting groups
1090416|NCT00588848|B2|Baseline|CPAP|"Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night)~Continuous Positive Airway Pressure (CPAP) : Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery)"
1090436|NCT00588809|P1|Participant Flow|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~selumetinib: Given PO"
1091331|NCT00586196|O1|Outcome|Donepezil : 5 mg Each Day for 30 Days|donepezil : 5 mg each day for 30 days
1090417|NCT00588848|B1|Baseline|AUTOCPAP|"An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night)~Autoadjusting Continuous Positive Airway Pressure (VPAP Auto) : An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery)."
1090418|NCT00588848|P2|Participant Flow|CPAP|"Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night)~Continuous Positive Airway Pressure (CPAP) : Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery)"
1090419|NCT00588848|P1|Participant Flow|AUTOCPAP|"An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night)~Autoadjusting Continuous Positive Airway Pressure (VPAP Auto) : An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery)."
1090420|NCT00588848|O2|Outcome|CPAP|"Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night)~Continuous Positive Airway Pressure (CPAP) : Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery)"
1090421|NCT00588848|O1|Outcome|AUTOCPAP|"An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night)~Autoadjusting Continuous Positive Airway Pressure (VPAP Auto) : An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery)."
1090422|NCT00588848|O2|Outcome|CPAP|"Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night)~Continuous Positive Airway Pressure (CPAP) : Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery)"
1090423|NCT00588848|O1|Outcome|AUTOCPAP|"An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night)~Autoadjusting Continuous Positive Airway Pressure (VPAP Auto) : An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery)."
1090424|NCT00588848|E2|Reported Event|CPAP|"Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night)~Continuous Positive Airway Pressure (CPAP) : Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery)"
1090425|NCT00588848|E1|Reported Event|AUTOCPAP|"An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night)~Autoadjusting Continuous Positive Airway Pressure (VPAP Auto) : An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery)."
1090426|NCT00588822|B1|Baseline|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.~Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
1090427|NCT00588822|P1|Participant Flow|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.~Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
1090428|NCT00588822|O1|Outcome|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.~Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
1090429|NCT00588822|O1|Outcome|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.~Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
1090430|NCT00588822|O1|Outcome|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.~Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
1090431|NCT00588822|O1|Outcome|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.~Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
1090432|NCT00588822|O1|Outcome|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.~Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
1090433|NCT00588822|O1|Outcome|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.~Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
1090434|NCT00588822|E1|Reported Event|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.~Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
1090435|NCT00588809|B1|Baseline|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~selumetinib: Given PO"
1090486|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
1090437|NCT00588809|O1|Outcome|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~selumetinib: Given PO"
1090438|NCT00588809|O1|Outcome|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~selumetinib: Given PO"
1090439|NCT00588809|O1|Outcome|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~selumetinib: Given PO"
1090440|NCT00588809|O1|Outcome|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~selumetinib: Given PO"
1090441|NCT00588809|O1|Outcome|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~selumetinib: Given PO"
1090442|NCT00588809|O1|Outcome|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~selumetinib: Given PO"
1090443|NCT00588809|E1|Reported Event|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~selumetinib: Given PO"
1090444|NCT00588731|B3|Baseline|Total|Total of all reporting groups
1090445|NCT00588731|B2|Baseline|Placebo|Placebo: Placebo
1090446|NCT00588731|B1|Baseline|Cannabidiol|Cannabidiol: Active Cannabidiol daily over 6 weeks
1090447|NCT00588731|P2|Participant Flow|Placebo|Placebo: Placebo
1090448|NCT00588731|P1|Participant Flow|Cannabidiol|Cannabidiol: Active Cannabidiol daily over 6 weeks
1090449|NCT00588731|O2|Outcome|Placebo|Placebo: Placebo
1090450|NCT00588731|O1|Outcome|Cannabidiol|Cannabidiol: Active Cannabidiol daily over 6 weeks
1090451|NCT00588731|O2|Outcome|Placebo|Placebo: Placebo
1090452|NCT00588731|O1|Outcome|Cannabidiol|Cannabidiol: Active Cannabidiol daily over 6 weeks
1090453|NCT00588731|E2|Reported Event|Placebo|Placebo: Placebo
1090454|NCT00588731|E1|Reported Event|Cannabidiol|Cannabidiol: Active Cannabidiol daily over 6 weeks
1090455|NCT00588692|B3|Baseline|Total|Total of all reporting groups
1090456|NCT00588692|B2|Baseline|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
1090457|NCT00588692|B1|Baseline|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
1090458|NCT00588692|P2|Participant Flow|SphygmoCor Blinded|"Sphygmocor values will be blinded to the investigator.~SphygmoCor: The SphygmoCor, a hand-held tonometer will assess central blood pressure noninvasively. This pencil-lide device is applied over the radial artery, and uses a validated mathematical transformation to derive central aortic pressure."
1090459|NCT00588692|P1|Participant Flow|SphygmoCor Unblinded|"The use of the sphygmocor values will determine medication adjustments to optimize heart failure (HF) treatment.~SphygmoCor: The SphygmoCor, a hand-held tonometer will assess central blood pressure noninvasively. This pencil-lide device is applied over the radial artery, and uses a validated mathematical transformation to derive central aortic pressure."
1090460|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
1090461|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
1090462|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
1090463|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
1090464|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
1090465|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
1090466|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
1090467|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
1090468|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
1090469|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
1090470|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
1090471|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
1090472|NCT00588692|O2|Outcome|Control|Sphygmocor values will be blinded to the investigator.
1090473|NCT00588692|O1|Outcome|Treatment|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
1090474|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
1090475|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
1090476|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
1090477|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
1090478|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
1090479|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
1090480|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
1090481|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
1090482|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
1090483|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
1090484|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
1090485|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
1090487|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
1090488|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
1090489|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
1090490|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
1090491|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
1090492|NCT00588692|E2|Reported Event|Control|"Sphygmocor values will be blinded to the investigator.~SphygmoCor: The SphygmoCor, a hand-held tonometer will assess central blood pressure noninvasively. This pencil-like device is applied over the radial artery, and uses a validated mathematical transformation to derive central aortic pressure."
1090493|NCT00588692|E1|Reported Event|Treatment|"The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.~SphygmoCor: The SphygmoCor, a hand-held tonometer will assess central blood pressure noninvasively. This pencil-like device is applied over the radial artery, and uses a validated mathematical transformation to derive central aortic pressure."
1090494|NCT00588666|B1|Baseline|Treatment|Bevacizumab, Carboplatin, Gemcitabine: Patients will initially receive bevacizumab 10 mg/kg followed by a 2 week treatment-free interval. Treatment will then begin with combination therapy. Gemcitabine 1000 mg/m2 will be administered intravenously on day 1 and 8 and carboplatin AUC 4.5 on day 1 with treatment recycled every 21 days. Bevacizumab will be administered at a dose of 15 mg/kg on day 1 of each 21-day cycle. Restaging evaluations will be performed after every 3 cycles of treatment (approximately 9 weeks). Patients will receive a total of 6 cycles of chemotherapy unless disease progression or unacceptable toxicity occurs. Patients who achieve stable disease, a partial response, or a complete response after completion of 6 cycles, will be eligible to continue bevacizumab at the same dose and schedule until disease progression for a maximum of 18 additional doses.
1090495|NCT00588666|P1|Participant Flow|Treatment|Bevacizumab, Carboplatin, Gemcitabine: Patients will initially receive bevacizumab 10 mg/kg followed by a 2 week treatment-free interval. Treatment will then begin with combination therapy. Gemcitabine 1000 mg/m2 will be administered intravenously on day 1 and 8 and carboplatin AUC 4.5 on day 1 with treatment recycled every 21 days. Bevacizumab will be administered at a dose of 15 mg/kg on day 1 of each 21-day cycle. Restaging evaluations will be performed after every 3 cycles of treatment (approximately 9 weeks). Patients will receive a total of 6 cycles of chemotherapy unless disease progression or unacceptable toxicity occurs. Patients who achieve stable disease, a partial response, or a complete response after completion of 6 cycles, will be eligible to continue bevacizumab at the same dose and schedule until disease progression for a maximum of 18 additional doses.
1090496|NCT00588666|O1|Outcome|Treatment|Bevacizumab, Carboplatin, Gemcitabine: Patients will initially receive bevacizumab 10 mg/kg followed by a 2 week treatment-free interval. Treatment will then begin with combination therapy. Gemcitabine 1000 mg/m2 will be administered intravenously on day 1 and 8 and carboplatin AUC 4.5 on day 1 with treatment recycled every 21 days. Bevacizumab will be administered at a dose of 15 mg/kg on day 1 of each 21-day cycle. Restaging evaluations will be performed after every 3 cycles of treatment (approximately 9 weeks). Patients will receive a total of 6 cycles of chemotherapy unless disease progression or unacceptable toxicity occurs. Patients who achieve stable disease, a partial response, or a complete response after completion of 6 cycles, will be eligible to continue bevacizumab at the same dose and schedule until disease progression for a maximum of 18 additional doses.
1090497|NCT00588666|O1|Outcome|Treatment|Bevacizumab, Carboplatin, Gemcitabine: Patients will initially receive bevacizumab 10 mg/kg followed by a 2 week treatment-free interval. Treatment will then begin with combination therapy. Gemcitabine 1000 mg/m2 will be administered intravenously on day 1 and 8 and carboplatin AUC 4.5 on day 1 with treatment recycled every 21 days. Bevacizumab will be administered at a dose of 15 mg/kg on day 1 of each 21-day cycle. Restaging evaluations will be performed after every 3 cycles of treatment (approximately 9 weeks). Patients will receive a total of 6 cycles of chemotherapy unless disease progression or unacceptable toxicity occurs. Patients who achieve stable disease, a partial response, or a complete response after completion of 6 cycles, will be eligible to continue bevacizumab at the same dose and schedule until disease progression for a maximum of 18 additional doses.
1090498|NCT00588666|E1|Reported Event|Treatment|Bevacizumab, Carboplatin, Gemcitabine: Patients will initially receive bevacizumab 10 mg/kg followed by a 2 week treatment-free interval. Treatment will then begin with combination therapy. Gemcitabine 1000 mg/m2 will be administered intravenously on day 1 and 8 and carboplatin AUC 4.5 on day 1 with treatment recycled every 21 days. Bevacizumab will be administered at a dose of 15 mg/kg on day 1 of each 21-day cycle. Restaging evaluations will be performed after every 3 cycles of treatment (approximately 9 weeks). Patients will receive a total of 6 cycles of chemotherapy unless disease progression or unacceptable toxicity occurs. Patients who achieve stable disease, a partial response, or a complete response after completion of 6 cycles, will be eligible to continue bevacizumab at the same dose and schedule until disease progression for a maximum of 18 additional doses.
1090499|NCT00588640|B1|Baseline|Patients Receiving D-methadone 40 mg|Patient Receiving D-methadone 40 mg
1090500|NCT00588640|P1|Participant Flow|Patients Receiving D-methadone 40 mg|Patient Receiving D-methadone 40 mg
1090501|NCT00588640|O1|Outcome|Phase I, Cohort l|"oral d-methadone 40 mg~d-Methadone: 8 subjects to receive 40 mg d-Methadone twice a day"
1090502|NCT00588640|E1|Reported Event|Patients Receiving D-methadone 40 mg|Patient Receiving D-methadone 40 mg
1090503|NCT00588536|B1|Baseline|MTX, 6-TG and Leucovorin|"Methotrexate: MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs~6-Thioguanine: 6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose.~Leucovorin Calcium: 5mg orally at 36,48, and 60hrs (or 12 hrs after the dose of 6-TG and then every 12 hrs for a total of 3 doses)"
1090504|NCT00588536|P1|Participant Flow|MTX, 6-TG and Leucovorin|"Methotrexate: MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs~6-Thioguanine: 6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose.~Leucovorin Calcium: 5mg orally at 36,48, and 60hrs (or 12 hrs after the dose of 6-TG and then every 12 hrs for a total of 3 doses)"
1090528|NCT00588406|P1|Participant Flow|Budesonide|"Budesonide, 2mg, 4 doses, plus standard care~Budesonide: 2mg/dose by nebulizer, four doses over 3 hours~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
1090505|NCT00588536|O1|Outcome|MTX, 6-TG and Leucovorin|"Methotrexate: MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs~6-Thioguanine: 6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose.~Leucovorin Calcium: 5mg orally at 36,48, and 60hrs (or 12 hrs after the dose of 6-TG and then every 12 hrs for a total of 3 doses)"
1090506|NCT00588536|E1|Reported Event|MTX, 6-TG and Leucovorin|"Methotrexate: MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs~6-Thioguanine: 6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose.~Leucovorin Calcium: 5mg orally at 36,48, and 60hrs (or 12 hrs after the dose of 6-TG and then every 12 hrs for a total of 3 doses)"
1090507|NCT00588471|B3|Baseline|Total|Total of all reporting groups
1090508|NCT00588471|B2|Baseline|Placebo|Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.
1090509|NCT00588471|B1|Baseline|Simvastatin|Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.
1090510|NCT00588471|P2|Participant Flow|Placebo|Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.
1090511|NCT00588471|P1|Participant Flow|Simvastatin|Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.
1090512|NCT00588471|O2|Outcome|Placebo|Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.
1090513|NCT00588471|O1|Outcome|Simvastatin|Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.
1090514|NCT00588471|O2|Outcome|Placebo|Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.
1090515|NCT00588471|O1|Outcome|Simvastatin|Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.
1090516|NCT00588471|E2|Reported Event|Placebo|Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.
1090517|NCT00588471|E1|Reported Event|Simvastatin|Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.
1090518|NCT00588445|B1|Baseline|Treatment|"Gefitinib: Patients will receive gefitinib 250 mg po daily for at least 21 days preoperatively (depending on the timing of the surgery). Treatment with gefitinib will be stopped 2 days before the date of surgery.~Patients who have had at least a minor response to gefitinib therapy preoperatively (> 25% reduction in tumor measured bidimensionally) and / or have mutations in the protein-tyrosine kinase domain of the EGF receptor gene identified will continue on the study and will resume gefitinib treatment after at least 7 days from surgery providing adequate wound healing has occurred.~Patients who are determined to be candidates for adjuvant chemotherapy and/or radiation therapy by their treating physician may receive treatment with adjuvant chemotherapy and/or radiation therapy. The post-operative gefitinib will be started after completion of the chemotherapy and/or radiation therapy."
1090519|NCT00588445|P1|Participant Flow|Treatment|"Gefitinib: Patients will receive gefitinib 250 mg po daily for at least 21 days preoperatively (depending on the timing of the surgery). Treatment with gefitinib will be stopped 2 days before the date of surgery.~Patients who have had at least a minor response to gefitinib therapy preoperatively (> 25% reduction in tumor measured bidimensionally) and / or have mutations in the protein-tyrosine kinase domain of the EGF receptor gene identified will continue on the study and will resume gefitinib treatment after at least 7 days from surgery providing adequate wound healing has occurred.~Patients who are determined to be candidates for adjuvant chemotherapy and/or radiation therapy by their treating physician may receive treatment with adjuvant chemotherapy and/or radiation therapy. The post-operative gefitinib will be started after completion of the chemotherapy and/or radiation therapy."
1090520|NCT00588445|O2|Outcome|EGFR Mutation Negative|Tumor specimens analyzed for EGFR mutation
1090521|NCT00588445|O1|Outcome|EGFR Mutation Positive|Tumor specimens analyzed for EGFR mutation
1090522|NCT00588445|O1|Outcome|Treatment|"Gefitinib: Patients will receive gefitinib 250 mg po daily for at least 21 days preoperatively (depending on the timing of the surgery). Treatment with gefitinib will be stopped 2 days before the date of surgery.~Patients who have had at least a minor response to gefitinib therapy preoperatively (> 25% reduction in tumor measured bidimensionally) and / or have mutations in the protein-tyrosine kinase domain of the EGF receptor gene identified will continue on the study and will resume gefitinib treatment after at least 7 days from surgery providing adequate wound healing has occurred.~Patients who are determined to be candidates for adjuvant chemotherapy and/or radiation therapy by their treating physician may receive treatment with adjuvant chemotherapy and/or radiation therapy. The post-operative gefitinib will be started after completion of the chemotherapy and/or radiation therapy."
1090523|NCT00588445|E1|Reported Event|Treatment|"Gefitinib: Patients will receive gefitinib 250 mg po daily for at least 21 days preoperatively (depending on the timing of the surgery). Treatment with gefitinib will be stopped 2 days before the date of surgery.~Patients who have had at least a minor response to gefitinib therapy preoperatively (> 25% reduction in tumor measured bidimensionally) and / or have mutations in the protein-tyrosine kinase domain of the EGF receptor gene identified will continue on the study and will resume gefitinib treatment after at least 7 days from surgery providing adequate wound healing has occurred.~Patients who are determined to be candidates for adjuvant chemotherapy and/or radiation therapy by their treating physician may receive treatment with adjuvant chemotherapy and/or radiation therapy. The post-operative gefitinib will be started after completion of the chemotherapy and/or radiation therapy."
1090524|NCT00588406|B3|Baseline|Total|Total of all reporting groups
1090525|NCT00588406|B2|Baseline|Placebo|"Placebo plus standard care~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
1090526|NCT00588406|B1|Baseline|Budesonide|"Budesonide, 2mg, 4 doses, plus standard care~Budesonide: 2mg/dose by nebulizer, four doses over 3 hours~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
1090527|NCT00588406|P2|Participant Flow|Placob|"Placebo plus standard care~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
1090529|NCT00588406|O2|Outcome|Placebo|"Placebo plus standard care~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
1090530|NCT00588406|O1|Outcome|Budesonide|"Budesonide, 2mg, 4 doses, plus standard care~Budesonide: 2mg/dose by nebulizer, four doses over 3 hours~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
1090531|NCT00588406|O2|Outcome|Placebo|"Placebo plus standard care~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
1090532|NCT00588406|O1|Outcome|Budesonide|"Budesonide, 2mg, 4 doses, plus standard care~Budesonide: 2mg/dose by nebulizer, four doses over 3 hours~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
1090533|NCT00588406|E2|Reported Event|Placebo|"Placebo plus standard care~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
1090534|NCT00588406|E1|Reported Event|Budesonide|"Budesonide, 2mg, 4 doses, plus standard care~Budesonide: 2mg/dose by nebulizer, four doses over 3 hours~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
1090535|NCT00588380|B1|Baseline|Overall Study|All participants recieved glucose for 2 hours then Glucagon Like Peptide-1 (GLP-1) intravenously at a rate of 0.75 pmol/kg/min for 1 hour followed by 1.5 pmol/kg/min for the subsequent hour. The study lasted for 240 minutes.
1090536|NCT00588380|P1|Participant Flow|Overall Study|All participants recieved glucose for 2 hours then Glucagon Like Peptide-1 (GLP-1) intravenously at a rate of 0.75 pmol/kg/min for 1 hour followed by 1.5 pmol/kg/min for the subsequent hour. The study lasted for 240 minutes.
1090537|NCT00588380|O1|Outcome|Overall Study|All participants recieved glucose for 2 hours then Glucagon Like Peptide-1 (GLP-1) intravenously at a rate of 0.75 pmol/kg/min for 1 hour followed by 1.5 pmol/kg/min for the subsequent hour. The study lasted for 240 minutes.
1090538|NCT00588380|O1|Outcome|All Participants|C-peptide as a marker of insulin secretion
1090539|NCT00588380|E1|Reported Event|Overall Study|All participants recieved glucose for 2 hours then Glucagon Like Peptide-1 (GLP-1) intravenously at a rate of 0.75 pmol/kg/min for 1 hour followed by 1.5 pmol/kg/min for the subsequent hour. The study lasted for 240 minutes.
1090540|NCT00588354|B3|Baseline|Total|Total of all reporting groups
1090541|NCT00588354|B2|Baseline|2% Lidocaine and Triamcinolone (40 mg).|"Patients received one to three injections administered at about 2 weeks apart. Patients,investigators, and study coordinators were blinded to the treatment.~The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. Other outcomes included Patient Global Impression of Change and functional measures."
1090542|NCT00588354|B1|Baseline|2% Lidocaine and Clonidine (200 or 400 ug)|"Patients received one to three injections administered at about 2 weeks apart. Patients,investigators, and study coordinators were blinded to the treatment.~The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. Other outcomes included Patient Global Impression of Change and functional measures."
1090543|NCT00588354|P2|Participant Flow|2% Lidocaine and Triamcinolone (40 mg).|"Patients received one to three injections administered at about 2 weeks apart. Patients,investigators, and study coordinators were blinded to the treatment.~The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. Other outcomes included Patient Global Impression of Change and functional measures."
1090544|NCT00588354|P1|Participant Flow|2% Lidocaine and Clonidine (200 or 400 ug)|"Patients received one to three injections administered at about 2 weeks apart. Patients,investigators, and study coordinators were blinded to the treatment.~The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. Other outcomes included Patient Global Impression of Change and functional measures."
1090545|NCT00588354|O2|Outcome|2% Lidocaine and Triamcinolone (40 mg)|Transforaminal epidural steroid injection
1090546|NCT00588354|O1|Outcome|2% Lidociane and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
1090547|NCT00588354|O2|Outcome|2% Lidocaine and Triamcinolone (40 mg)|Transforaminal epidural steroid injection
1090548|NCT00588354|O1|Outcome|2% Lidociane and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
1090549|NCT00588354|O2|Outcome|2% Lidocaine and Triamcinolone (40 mg)|Transforaminal epidural steroid injection
1090550|NCT00588354|O1|Outcome|2% Lidociane and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
1090551|NCT00588354|O2|Outcome|2% Lidocaine and Triamcinolone (40 mg)|Transforaminal epidural steroid injection
1090552|NCT00588354|O1|Outcome|2% Lidocaine and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
1090553|NCT00588354|O2|Outcome|2% Lidocaine and Triamcinolone (40 mg)|Transforaminal epidural steroid injection
1090554|NCT00588354|O1|Outcome|2% Lidociane and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
1090555|NCT00588354|O2|Outcome|2% Lidocaine and Triamcinolone (40 mg)|Transforaminal epidural steroid injection
1090556|NCT00588354|O1|Outcome|2% Lidociane and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
1090557|NCT00588354|O2|Outcome|2% Lidocaine and Triamcinolone (40 mg)|Transforaminal epidural steroid injection
1090558|NCT00588354|O1|Outcome|2% Lidociane and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
1090559|NCT00588354|O2|Outcome|2% Lidocaine and Triamcinolone (40 mg)|Transforaminal epidural steroid injection
1090560|NCT00588354|O1|Outcome|2% Lidociane and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
1090561|NCT00588354|E2|Reported Event|2% Lidocaine and Triamcinolone (40 mg).|"Patients received one to three injections administered at about 2 weeks apart. Patients,investigators, and study coordinators were blinded to the treatment.~The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. Other outcomes included Patient Global Impression of Change and functional measures."
1090562|NCT00588354|E1|Reported Event|2% Lidocaine and Clonidine (200 or 400 ug)|"Patients received one to three injections administered at about 2 weeks apart. Patients,investigators, and study coordinators were blinded to the treatment.~The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. Other outcomes included Patient Global Impression of Change and functional measures."
1090563|NCT00588341|B1|Baseline|Treatment|Temozolomide: Patients will then be treated with TMZ according to the extended dosing schedule of 75mg/m2/day x 6 weeks every 8 weeks.
1172367|NCT00381303|O5|Outcome|Hispanic|
1090564|NCT00588341|P1|Participant Flow|Treatment|Temozolomide: Patients will then be treated with TMZ according to the extended dosing schedule of 75mg/m2/day x 6 weeks every 8 weeks.
1090565|NCT00588341|O1|Outcome|Treatment|Temozolomide: Patients will then be treated with TMZ according to the extended dosing schedule of 75mg/m2/day x 6 weeks every 8 weeks.
1090566|NCT00588341|E1|Reported Event|Treatment|Temozolomide: Patients will then be treated with TMZ according to the extended dosing schedule of 75mg/m2/day x 6 weeks every 8 weeks.
1090567|NCT00588159|B3|Baseline|Total|Total of all reporting groups
1090568|NCT00588159|B2|Baseline|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
1090569|NCT00588159|B1|Baseline|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
1090570|NCT00588159|P2|Participant Flow|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
1090571|NCT00588159|P1|Participant Flow|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
1090572|NCT00588159|O2|Outcome|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
1090573|NCT00588159|O1|Outcome|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
1090574|NCT00588159|O2|Outcome|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
1090575|NCT00588159|O1|Outcome|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
1090576|NCT00588159|O2|Outcome|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
1090577|NCT00588159|O1|Outcome|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
1090578|NCT00588159|O2|Outcome|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
1090579|NCT00588159|O1|Outcome|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
1090580|NCT00588159|O2|Outcome|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
1090581|NCT00588159|O1|Outcome|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
1090582|NCT00588159|O2|Outcome|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
1090583|NCT00588159|O1|Outcome|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
1090584|NCT00588159|E2|Reported Event|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
1090585|NCT00588159|E1|Reported Event|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
1090586|NCT00588146|B1|Baseline|Entire Study Population|Includes groups randomized to pegylated interferon alpha-2b first and standard care first.
1090587|NCT00588146|P2|Participant Flow|Standard Care, Then Pegylated Interferon Alpha2b|Standard care for 6 months, then weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week for 6 months.
1090588|NCT00588146|P1|Participant Flow|Pegylated Interferon Alpha2b, Then Standard Care|Weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week for 6 months, then standard care for 6 months.
1090589|NCT00588146|O2|Outcome|Standard Care, Then Pegylated Interferon Alpha2b|Standard care for 6 months, then weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week for 6 months.
1090590|NCT00588146|O1|Outcome|Pegylated Interferon Alpha2b, Then Standard Care|Weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week for 6 months, then standard care for 6 months.
1090591|NCT00588146|E2|Reported Event|Standard Care|Subjects received standard care for hereditary hemorrhagic telangiectasia.
1090592|NCT00588146|E1|Reported Event|Pegylated Interferon Alpha-2b|Weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week
1090593|NCT00588094|B1|Baseline|R-ICEesc|R-ICEesc will be administered with the intent of administering 2 cycles, each 21 days apart admixed with 4 doses of rituximab. G-CSF will be administered at 960 ug or 10 ug/kg if patient is > 100 kg after cycles one and two for PBPC collection for the first 10 patients enrolled. G-CSF will be administered in standard dosing for cycle one and then at 960 ug or 10 ug/kg (if patient is > 100 kg) after cycle two for PBPC collection for the remaining 22 patients. All responding patients who make at least 2 x 106 CD34+ cells/kg will receive high dose therapy and ASCT on other protocols.
1090594|NCT00588094|P1|Participant Flow|R-ICEesc|R-ICEesc will be administered with the intent of administering 2 cycles, each 21 days apart admixed with 4 doses of rituximab. G-CSF will be administered at 960 ug or 10 ug/kg if patient is > 100 kg after cycles one and two for PBPC collection for the first 10 patients enrolled. G-CSF will be administered in standard dosing for cycle one and then at 960 ug or 10 ug/kg (if patient is > 100 kg) after cycle two for PBPC collection for the remaining 22 patients. All responding patients who make at least 2 x 106 CD34+ cells/kg will receive high dose therapy and ASCT on other protocols.
1090595|NCT00588094|O1|Outcome|R-ICEesc|R-ICEesc will be administered with the intent of administering 2 cycles, each 21 days apart admixed with 4 doses of rituximab. G-CSF will be administered at 960 ug or 10 ug/kg if patient is > 100 kg after cycles one and two for PBPC collection for the first 10 patients enrolled. G-CSF will be administered in standard dosing for cycle one and then at 960 ug or 10 ug/kg (if patient is > 100 kg) after cycle two for PBPC collection for the remaining 22 patients. All responding patients who make at least 2 x 106 CD34+ cells/kg will receive high dose therapy and ASCT on other protocols.
1090596|NCT00588094|E1|Reported Event|R-ICEesc|R-ICEesc will be administered with the intent of administering 2 cycles, each 21 days apart admixed with 4 doses of rituximab. G-CSF will be administered at 960 ug or 10 ug/kg if patient is > 100 kg after cycles one and two for PBPC collection for the first 10 patients enrolled. G-CSF will be administered in standard dosing for cycle one and then at 960 ug or 10 ug/kg (if patient is > 100 kg) after cycle two for PBPC collection for the remaining 22 patients. All responding patients who make at least 2 x 106 CD34+ cells/kg will receive high dose therapy and ASCT on other protocols.
1090597|NCT00587990|B4|Baseline|Total|Total of all reporting groups
1090598|NCT00587990|B3|Baseline|(3) Placebo|"Participants will receive placebo injections~Placebo: Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA)."
1090639|NCT00587847|O1|Outcome|All Participants|All participants were included in the safety analysis.
1090640|NCT00587847|O1|Outcome|Single Arm, Open Label Trial.|single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year.
1090599|NCT00587990|B2|Baseline|(2) Higher MSC Dose|"Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 108 cells~Higher dose MSC injection: Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 108 cells. The injections will be administered following completion of CABG surgery."
1090600|NCT00587990|B1|Baseline|(1) Lower MSC Dose|"Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 107 cells~Lower dose mesenchymal stem cell (MSC) injection: Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 107 cells. The injections will be administered following completion of CABG surgery."
1090601|NCT00587990|P3|Participant Flow|(3) Placebo Injection|"Participants will receive placebo injections~Placebo: Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA)."
1090602|NCT00587990|P2|Participant Flow|(2) Higher MSC Dose|"Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 108 cells~Higher dose MSC injection: Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 108 cells. The injections will be administered following completion of CABG surgery."
1090603|NCT00587990|P1|Participant Flow|(1) Lower MSC Dose|"Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 107 cells~Lower dose mesenchymal stem cell (MSC) injection: Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 107 cells. The injections will be administered following completion of CABG surgery."
1090604|NCT00587990|O3|Outcome|(3) Placebo Injection|"Participants will receive placebo injections~Placebo: Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA)."
1090605|NCT00587990|O2|Outcome|(2) Higher MSC Dose|"Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 108 cells~Higher dose MSC injection: Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 108 cells. The injections will be administered following completion of CABG surgery."
1090606|NCT00587990|O1|Outcome|(1) Lower MSC Dose|"Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 107 cells~Lower dose mesenchymal stem cell (MSC) injection: Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 107 cells. The injections will be administered following completion of CABG surgery."
1090607|NCT00587990|E3|Reported Event|(3) Placebo Injection|"Participants will receive placebo injections~Placebo: Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA)."
1090608|NCT00587990|E2|Reported Event|(2) Higher MSC Dose|"Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 108 cells~Higher dose MSC injection: Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 108 cells. The injections will be administered following completion of CABG surgery."
1090609|NCT00587990|E1|Reported Event|(1) Lower MSC Dose|"Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 107 cells~Lower dose mesenchymal stem cell (MSC) injection: Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 107 cells. The injections will be administered following completion of CABG surgery."
1090610|NCT00587964|B1|Baseline|Treatment - Stereotactic Radiosurgery|Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases.
1090611|NCT00587964|P1|Participant Flow|Treatment - Stereotactic Radiosurgery|Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases.
1090612|NCT00587964|O1|Outcome|Treatment - Stereotactic Radiosurgery|Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases.
1090613|NCT00587964|E1|Reported Event|Treatment - Stereotactic Radiosurgery|Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases.
1090614|NCT00587860|B3|Baseline|Total|Total of all reporting groups
1090615|NCT00587860|B2|Baseline|Placebo|Placebo, twice a day
1090616|NCT00587860|B1|Baseline|St. John's Wort|St. John's Wort, 450 mg twice a day
1090617|NCT00587860|P2|Participant Flow|Placebo|Placebo, twice a day
1090618|NCT00587860|P1|Participant Flow|St. John's Wort|St. John's Wort, 450 mg twice a day
1090619|NCT00587860|O2|Outcome|Placebo|Placebo, twice a day
1090620|NCT00587860|O1|Outcome|St. John's Wort|St. John's Wort, 450 mg twice a day
1090621|NCT00587860|O2|Outcome|Placebo|Placebo, twice a day
1090622|NCT00587860|O1|Outcome|St. John's Wort|St. John's Wort, 450 mg twice a day
1090623|NCT00587860|O2|Outcome|Placebo|Placebo, twice a day
1090624|NCT00587860|O1|Outcome|St. John's Wort|St. John's Wort, 450 mg twice a day
1090625|NCT00587860|O2|Outcome|Placebo|Placebo, twice a day
1090626|NCT00587860|O1|Outcome|St. John's Wort|St. John's Wort, 450 mg twice a day
1090627|NCT00587860|O2|Outcome|Placebo|Placebo, twice a day
1090628|NCT00587860|O1|Outcome|St. John's Wort|St. John's Wort, 450 mg twice a day
1090629|NCT00587860|O2|Outcome|Placebo|Placebo, twice a day
1090630|NCT00587860|O1|Outcome|St. John's Wort|St. John's Wort, 450 mg twice a day
1090631|NCT00587860|O2|Outcome|Placebo|Placebo, twice a day
1090632|NCT00587860|O1|Outcome|St. John's Wort|St. John's Wort, 450 mg twice a day
1090633|NCT00587860|O2|Outcome|Placebo|Placebo, twice a day
1090634|NCT00587860|O1|Outcome|St. John's Wort|St. John's Wort, 450 mg twice a day
1090635|NCT00587860|E2|Reported Event|Placebo|Placebo, twice a day
1090636|NCT00587860|E1|Reported Event|St. John's Wort|St. John's Wort, 450 mg twice a day
1090637|NCT00587847|B1|Baseline|Single Arm, Open Label Trial.|single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year.
1090638|NCT00587847|P1|Participant Flow|Single Arm, Open Label Trial.|single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year.
1172368|NCT00381303|O4|Outcome|Caucasian|
1090641|NCT00587847|E1|Reported Event|Single Arm, Open Label Trial.|single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year.
1090642|NCT00587834|B1|Baseline|Gintuit and Autologous Free Gingival Graft (FGG)|Single application of Gintuit and FGG (control); split-mouth design
1090643|NCT00587834|P1|Participant Flow|Gintuit and Autologous Free Gingival Graft (FGG)|Single application of Gintuit and FGG (control); split-mouth design
1090644|NCT00587834|O2|Outcome|Gintuit Sensitive|Included ratings of Moderate and Severe
1090645|NCT00587834|O1|Outcome|Gintuit Not Sensitive|Included ratings of None and Mild
1090646|NCT00587834|O1|Outcome|Gintuit|Single application of Gintuit and FGG (control); split-mouth design. Number of subjects preferring Gintuit over Control.
1090647|NCT00587834|O1|Outcome|Gintuit|Single application;split-mouth design
1090648|NCT00587834|O2|Outcome|Gintuit Not Equally Firm as Adjacent Tissue|"Not Equally Firm includes responses of less firm and more firm"
1090649|NCT00587834|O1|Outcome|Gintuit Equally Firm as Adjacent Tissue|
1090650|NCT00587834|O2|Outcome|Gintuit Not Equally Red as Adjacent Tissue|"Not Equally Red includes responses of more red and less red"
1090651|NCT00587834|O1|Outcome|Gintuit Equally Red as Adjacent Tissue|
1090652|NCT00587834|O1|Outcome|Gintuit|Single application;split-mouth design
1090653|NCT00587834|E5|Reported Event|Other|Adverse events occurring at any other location in the body or systemic conditions
1090654|NCT00587834|E4|Reported Event|Mouth|Adverse events occurring in the mouth and not localized to the Gintuit, FGG, or palatal donation sites.
1090655|NCT00587834|E3|Reported Event|Palatal Donation Site|Adverse events occurring at the palatal donation site
1090656|NCT00587834|E2|Reported Event|Free Gingival Graft|Adverse events occurring at the autologous free gingival graft site
1090657|NCT00587834|E1|Reported Event|Gintuit|Adverse events occurring at the Gintuit treated site
1090658|NCT00587769|B1|Baseline|Medication Arm|Varenicline 1.0 mg po bid plus bupropion 150 mg po bid
1090659|NCT00587769|P1|Participant Flow|Medication Arm|Varenicline 1.0 mg po bid plus bupropion 150 mg po bid
1090660|NCT00587769|O1|Outcome|Medication Arm|Varenicline 1.0 mg po bid plus bupropion 150 mg po bid
1090661|NCT00587769|O1|Outcome|Medication Arm|Varenicline 1.0 mg po bid plus bupropion 150 mg po bid
1090662|NCT00587769|E1|Reported Event|Medication Arm|Varenicline 1.0 mg po bid plus bupropion 150 mg po bid
1090663|NCT00587678|B4|Baseline|Total|Total of all reporting groups
1090664|NCT00587678|B3|Baseline|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
1090665|NCT00587678|B2|Baseline|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
1090666|NCT00587678|B1|Baseline|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
1090667|NCT00587678|P3|Participant Flow|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
1090668|NCT00587678|P2|Participant Flow|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
1090669|NCT00587678|P1|Participant Flow|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
1090670|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
1090671|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
1090672|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
1090673|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
1090674|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
1090675|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
1090676|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
1090677|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
1090678|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
1090679|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
1090680|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
1090681|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
1090682|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
1090683|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
1090684|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
1090685|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
1090686|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
1090687|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
1090688|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
1090689|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
1090690|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
1090691|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
1091936|NCT00583713|O2|Outcome|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
1090692|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
1090693|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
1090694|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
1090695|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
1090696|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
1090697|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
1090698|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
1090699|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
1090700|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
1090701|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
1090702|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
1090703|NCT00587678|E3|Reported Event|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
1090704|NCT00587678|E2|Reported Event|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
1090705|NCT00587678|E1|Reported Event|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
1090706|NCT00587639|B1|Baseline|Active Treatment|All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
1090707|NCT00587639|P1|Participant Flow|Active Treatment|All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
1090708|NCT00587639|O1|Outcome|rTMS Treatment|All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
1090709|NCT00587639|O1|Outcome|rTMS Treatment|All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
1090710|NCT00587639|E1|Reported Event|Active Treatment|All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
1090711|NCT00587587|B3|Baseline|Total|Total of all reporting groups
1090712|NCT00587587|B2|Baseline|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
1090713|NCT00587587|B1|Baseline|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
1090714|NCT00587587|P2|Participant Flow|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
1090715|NCT00587587|P1|Participant Flow|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
1090716|NCT00587587|O2|Outcome|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
1090717|NCT00587587|O1|Outcome|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
1090718|NCT00587587|O2|Outcome|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
1090719|NCT00587587|O1|Outcome|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
1090720|NCT00587587|O2|Outcome|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
1090721|NCT00587587|O1|Outcome|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
1090722|NCT00587587|O2|Outcome|B (Control)|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
1090723|NCT00587587|O1|Outcome|A (Apligraf)|Apligraf (bilayered living cell therapy)
1090724|NCT00587587|O2|Outcome|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
1090725|NCT00587587|O1|Outcome|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
1090726|NCT00587587|O2|Outcome|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
1090727|NCT00587587|O1|Outcome|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
1090728|NCT00587587|O2|Outcome|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
1090729|NCT00587587|O1|Outcome|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
1090730|NCT00587587|O2|Outcome|B (Control)|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
1090731|NCT00587587|O1|Outcome|A (Apligraf)|Apligraf (bilayered living cell therapy)
1090732|NCT00587587|E2|Reported Event|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
1090733|NCT00587587|E1|Reported Event|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
1090734|NCT00587483|B4|Baseline|Total|Total of all reporting groups
1091937|NCT00583713|O1|Outcome|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
1090735|NCT00587483|B3|Baseline|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
1090736|NCT00587483|B2|Baseline|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
1090737|NCT00587483|B1|Baseline|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
1090738|NCT00587483|P3|Participant Flow|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
1090739|NCT00587483|P2|Participant Flow|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
1090740|NCT00587483|P1|Participant Flow|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
1090741|NCT00587483|O3|Outcome|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
1090742|NCT00587483|O2|Outcome|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
1090743|NCT00587483|O1|Outcome|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
1090744|NCT00587483|O3|Outcome|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
1090745|NCT00587483|O2|Outcome|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
1090746|NCT00587483|O1|Outcome|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
1090747|NCT00587483|O3|Outcome|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
1090748|NCT00587483|O2|Outcome|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
1090749|NCT00587483|O1|Outcome|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
1090750|NCT00587483|O3|Outcome|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
1090751|NCT00587483|O2|Outcome|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
1090752|NCT00587483|O1|Outcome|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
1090753|NCT00587483|O3|Outcome|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
1090754|NCT00587483|O2|Outcome|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
1090755|NCT00587483|O1|Outcome|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
1090756|NCT00587483|O3|Outcome|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
1090757|NCT00587483|O2|Outcome|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
1090758|NCT00587483|O1|Outcome|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
1090759|NCT00587483|O3|Outcome|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
1090760|NCT00587483|O2|Outcome|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
1090761|NCT00587483|O1|Outcome|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
1090762|NCT00587483|E3|Reported Event|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
1090763|NCT00587483|E2|Reported Event|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
1090764|NCT00587483|E1|Reported Event|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
1090765|NCT00587457|B4|Baseline|Total|Total of all reporting groups
1090766|NCT00587457|B3|Baseline|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090767|NCT00587457|B2|Baseline|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090768|NCT00587457|B1|Baseline|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090818|NCT00587288|B2|Baseline|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
1090769|NCT00587457|P3|Participant Flow|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090770|NCT00587457|P2|Participant Flow|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090771|NCT00587457|P1|Participant Flow|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090772|NCT00587457|O3|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090773|NCT00587457|O2|Outcome|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090774|NCT00587457|O1|Outcome|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090775|NCT00587457|O3|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090776|NCT00587457|O2|Outcome|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090777|NCT00587457|O1|Outcome|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090778|NCT00587457|O3|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090779|NCT00587457|O2|Outcome|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090780|NCT00587457|O1|Outcome|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090781|NCT00587457|O3|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090782|NCT00587457|O2|Outcome|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090783|NCT00587457|O1|Outcome|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090784|NCT00587457|O3|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090785|NCT00587457|O2|Outcome|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090786|NCT00587457|O1|Outcome|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090787|NCT00587457|O3|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090788|NCT00587457|O2|Outcome|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090789|NCT00587457|O1|Outcome|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090790|NCT00587457|O3|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090791|NCT00587457|O2|Outcome|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090792|NCT00587457|O1|Outcome|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090793|NCT00587457|O3|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090794|NCT00587457|O2|Outcome|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090795|NCT00587457|O1|Outcome|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090796|NCT00587457|O3|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090797|NCT00587457|O2|Outcome|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090798|NCT00587457|O1|Outcome|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090799|NCT00587457|O3|Outcome|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090800|NCT00587457|O2|Outcome|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090801|NCT00587457|O1|Outcome|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090802|NCT00587457|E3|Reported Event|CAT-8015 20 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090803|NCT00587457|E2|Reported Event|CAT-8015 10 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090804|NCT00587457|E1|Reported Event|CAT-8015 5 Microgram Per Kilogram (mcg/kg)|Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
1090805|NCT00587431|B3|Baseline|Total|Total of all reporting groups
1090806|NCT00587431|B2|Baseline|Lupron and Docetaxel (70 mg/m2) and Testosterone for 3 Days|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days"
1090807|NCT00587431|B1|Baseline|Lupron and Docetaxel (75mg/m2) and Testosterone for 7 Days|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days"
1090808|NCT00587431|P2|Participant Flow|Lupron and Docetaxel (70 mg/m2) and Testosterone for 3 Days|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days"
1090809|NCT00587431|P1|Participant Flow|Lupron and Docetaxel (75mg/m2) and Testosterone for 7 Days|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days"
1090810|NCT00587431|O1|Outcome|All Participants|All participants
1090811|NCT00587431|O4|Outcome|Lupron + Docetaxel (70 mg/m2) + Testosterone (Metastatic)|"(Metastatic) GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days"
1090812|NCT00587431|O3|Outcome|Lupron +Docetaxel (70 mg/m2) +Testosterone (RISING PSA)|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days"
1090813|NCT00587431|O2|Outcome|Lupron + Docetaxel (75mg/m2) + Testosterone for (Metastatic)|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days"
1090814|NCT00587431|O1|Outcome|Lupron + Docetaxel (75mg/m2) +Testosterone (RISING PSA)|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days"
1090815|NCT00587431|E2|Reported Event|Lupron and Docetaxel (70 mg/m2) and Testosterone for 3 Days|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days"
1090816|NCT00587431|E1|Reported Event|Lupron and Docetaxel (75mg/m2) and Testosterone for 7 Days|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days"
1090817|NCT00587288|B3|Baseline|Total|Total of all reporting groups
1172369|NCT00381303|O3|Outcome|Black|
1090819|NCT00587288|B1|Baseline|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
1090820|NCT00587288|P2|Participant Flow|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
1090821|NCT00587288|P1|Participant Flow|Reslizumab 3 mg/kg|reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
1090822|NCT00587288|O2|Outcome|Placebo|Saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
1090823|NCT00587288|O1|Outcome|Reslizumab 3 mg/kg|Reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
1090824|NCT00587288|O2|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
1090825|NCT00587288|O1|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
1090826|NCT00587288|O2|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
1090827|NCT00587288|O1|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
1090828|NCT00587288|O2|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
1090829|NCT00587288|O1|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
1090830|NCT00587288|O2|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
1090831|NCT00587288|O1|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
1090832|NCT00587288|O2|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
1090833|NCT00587288|O1|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
1090834|NCT00587288|O2|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
1090835|NCT00587288|O1|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
1090836|NCT00587288|E2|Reported Event|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
1090837|NCT00587288|E1|Reported Event|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
1090838|NCT00587223|B1|Baseline|Apligraf/Control|Apligraf (a living bilayered cell therapy product) Control (a primary nonadherent dressing, nonstick gauze, retainer dressing)
1090839|NCT00587223|P1|Participant Flow|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
1090840|NCT00587223|O2|Outcome|Control|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. Control lesions are treated with standard wound dressings.
1090841|NCT00587223|O1|Outcome|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
1090842|NCT00587223|O2|Outcome|Control|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. Control lesions are treated with standard wound dressings.
1090843|NCT00587223|O1|Outcome|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
1090844|NCT00587223|O2|Outcome|Control|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. Control lesions are treated with standard wound dressings.
1090845|NCT00587223|O1|Outcome|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
1090846|NCT00587223|O2|Outcome|Control|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. Control lesions are treated with standard wound dressings.
1090847|NCT00587223|O1|Outcome|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
1090848|NCT00587223|O2|Outcome|Control|Within subject control: 2 lesions per subject randomized to receive Apligraf or Control treatment. Control treated lesions receive standard wound dressings.
1090849|NCT00587223|O1|Outcome|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
1090850|NCT00587223|O2|Outcome|Control|Within subject control: 2 lesions per subject randomized to receive Apligraf or Control treatment. Control treated lesion receives standard wound dressings.
1090851|NCT00587223|O1|Outcome|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
1090852|NCT00587223|E1|Reported Event|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
1090853|NCT00587171|B3|Baseline|Total|Total of all reporting groups
1090854|NCT00587171|B2|Baseline|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
1090855|NCT00587171|B1|Baseline|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
1090856|NCT00587171|P2|Participant Flow|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
1090857|NCT00587171|P1|Participant Flow|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
1090858|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
1090859|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
1090860|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
1090861|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
1090862|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
1090863|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
1090864|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
1090865|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
1090866|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
1090867|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
1090868|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
1090869|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
1090870|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
1090871|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
1090872|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
1090873|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
1090874|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
1090875|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
1090876|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
1090877|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
1090878|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
1090879|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
1090880|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
1090881|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
1090882|NCT00587171|E2|Reported Event|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
1090883|NCT00587171|E1|Reported Event|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
1090884|NCT00587158|B3|Baseline|Total|Total of all reporting groups
1090885|NCT00587158|B2|Baseline|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
1090886|NCT00587158|B1|Baseline|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
1090887|NCT00587158|P2|Participant Flow|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive therapy consisting of induction therapy with Alemtuzumab (Campath®) and Methylprednisolone (Solumedrol®), then maintained with corticosteroid avoidance using Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®). In addition, subjects in this group will receive the study medication paricalcitol (Zemplar®).
1090888|NCT00587158|P1|Participant Flow|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies consisting of induction therapy with Alemtuzumab (Campath®) and Methylprednisolone (Solumedrol®), then maintained with corticosteroid avoidance using Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
1090889|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
1090890|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
1090891|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
1090892|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
1090893|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
1090894|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
1090895|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
1090896|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
1090897|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
1090898|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
1090899|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
1090900|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
1090901|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
1090902|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
1090903|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
1090904|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
1090905|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
1090906|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
1090907|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
1090908|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
1090909|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
1090910|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
1090911|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
1090912|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
1090913|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
1091332|NCT00586196|O2|Outcome|Placebo : Encapsulated Cornstarch|Placebo : Encapsulated cornstarch One capsule daily for 30 days
1090914|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
1090915|NCT00587158|E2|Reported Event|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
1090916|NCT00587158|E1|Reported Event|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
1090917|NCT00587132|B5|Baseline|Total|Total of all reporting groups
1090918|NCT00587132|B4|Baseline|Clinical Symptoms of Pancreatic Cancer, Normal CT|10 adults age 35-99 with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks.
1090919|NCT00587132|B3|Baseline|Peutz-Jeghers Syndrome|"10 adults age 35-99 with Peutz-Jeghers syndrome.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
1090920|NCT00587132|B2|Baseline|Familial Pancreatic Cancer|"10 adults age 35-99 with familial pancreatic cancer with two or more first degree relatives with pancreatic cancer~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
1090921|NCT00587132|B1|Baseline|New Onset Diabetes|"10 adults, diagnosed diabetes within two years, and at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum cancer antigen 19-9 (CA 19-9), or those undergoing endoscopic ultrasound (EUS) with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
1090922|NCT00587132|P4|Participant Flow|Clinical Symptoms of Pancreatic Cancer, Normal CT|Adults age 35-99 with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks.
1090923|NCT00587132|P3|Participant Flow|Peutz-Jeghers Syndrome|"Adults age 35-99 with Peutz-Jeghers syndrome.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
1090924|NCT00587132|P2|Participant Flow|Familial Pancreatic Cancer|"Adults age 35-99 with familial pancreatic cancer with two or more first degree relatives with pancreatic cancer~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
1090925|NCT00587132|P1|Participant Flow|New Onset Diabetes|"Adults diagnosed diabetes within two years, and at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum cancer antigen 19-9 (CA 19-9), or those undergoing endoscopic ultrasound (EUS) with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
1090926|NCT00587132|O4|Outcome|Clinical Symptoms of Pancreatic Cancer, Normal CT|"Adults age 35-99 with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
1090927|NCT00587132|O3|Outcome|Peutz-Jeghers Syndrome|"Adults age 35-99 with Peutz-Jeghers syndrome.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
1090928|NCT00587132|O2|Outcome|Familial Pancreatic Cancer|"Adults age 35-99 with familial pancreatic cancer with two or more first degree relatives with pancreatic cancer~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
1090929|NCT00587132|O1|Outcome|New Onset Diabetes|"Adults, diagnosed diabetes within two years, and at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum cancer antigen 19-9 (CA 19-9), or those undergoing endoscopic ultrasound (EUS) with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
1090930|NCT00587132|E4|Reported Event|Clinical Symptoms of Pancreatic Cancer, Normal CT|10 adults age 35-99 with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks.
1090931|NCT00587132|E3|Reported Event|Peutz-Jeghers Syndrome|"10 adults age 35-99 with Peutz-Jeghers syndrome.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
1090932|NCT00587132|E2|Reported Event|Familial Pancreatic Cancer|"10 adults age 35-99 with familial pancreatic cancer with two or more first degree relatives with pancreatic cancer~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
1090933|NCT00587132|E1|Reported Event|New Onset Diabetes|"10 adults, diagnosed diabetes within two years, and at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum cancer antigen 19-9 (CA 19-9), or those undergoing endoscopic ultrasound (EUS) with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
1090934|NCT00587054|B1|Baseline|Transplant Patients|Adult Patients (>18 years) with Lymphohematopoietic Disorders will receive Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine
1090935|NCT00587054|P1|Participant Flow|Transplant Patients|Adult Patients (>18 years) with Lymphohematopoietic Disorders will receive Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine
1090936|NCT00587054|O1|Outcome|Transplant Patients|Adult Patients (>18 years) with Lymphohematopoietic Disorders will receive Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine
1090976|NCT00586729|P2|Participant Flow|5% Mafenide Acetate|5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
1090937|NCT00587054|E1|Reported Event|Transplant Patients|Adult Patients (>18 years) with Lymphohematopoietic Disorders will receive Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine
1090938|NCT00587041|B4|Baseline|Total|Total of all reporting groups
1090939|NCT00587041|B3|Baseline|Placebo|Participants received placebo for 6 weeks: 1 placebo packet daily and 1 placebo capsule twice daily
1090940|NCT00587041|B2|Baseline|Oxadrop|Participants received Oxadrop for 6 weeks: Oxadrop 1 packet daily plus 1 placebo capsule twice daily. Each gram of Oxadrop® contains 2x1011 bacteria (L. acidophilus, L. brevis, S. thermophilus, and B. infantis)
1090941|NCT00587041|B1|Baseline|Agri-King Synbiotic|Participants received AKSB for 6 weeks: AKSB 1 capsule twice daily plus 1 placebo packet daily. AKSB contains Fructo-oligosaccharide; Enterococcus faecium (SF68); Saccharomyces cerevisiae subspecies Boulardi; and Saccharomyces cerevisiae
1090942|NCT00587041|P3|Participant Flow|Placebo|Participants received placebo for 6 weeks: 1 placebo packet daily and 1 placebo capsule twice daily
1090943|NCT00587041|P2|Participant Flow|Oxadrop|Participants received Oxadrop for 6 weeks: Oxadrop 1 packet daily plus 1 placebo capsule twice daily. Each gram of Oxadrop® contains 2x1011 bacteria (L. acidophilus, L. brevis, S. thermophilus, and B. infantis)
1090944|NCT00587041|P1|Participant Flow|Agri-King Synbiotic|Participants received AKSB for 6 weeks: AKSB 1 capsule twice daily plus 1 placebo packet daily. AKSB contains Fructo-oligosaccharide; Enterococcus faecium (SF68); Saccharomyces cerevisiae subspecies Boulardi; and Saccharomyces cerevisiae
1090945|NCT00587041|O3|Outcome|Agri-King Synbiotic|Participants received AKSB for 6 weeks: AKSB 1 capsule twice daily plus 1 placebo packet daily. AKSB contains Fructo-oligosaccharide; Enterococcus faecium (SF68); Saccharomyces cerevisiae subspecies Boulardi; and Saccharomyces cerevisiae
1090946|NCT00587041|O2|Outcome|Oxadrop|Participants received Oxadrop for 6 weeks: Oxadrop 1 packet daily plus 1 placebo capsule twice daily. Each gram of Oxadrop® contains 2x1011 bacteria (L. acidophilus, L. brevis, S. thermophilus, and B. infantis)
1090947|NCT00587041|O1|Outcome|Placebo|Participants received placebo for 6 weeks: 1 placebo packet daily and 1 placebo capsule twice daily
1090948|NCT00587041|O3|Outcome|Agri-King Synbiotic|Participants received AKSB for 6 weeks: AKSB 1 capsule twice daily plus 1 placebo packet daily. AKSB contains Fructo-oligosaccharide; Enterococcus faecium (SF68); Saccharomyces cerevisiae subspecies Boulardi; and Saccharomyces cerevisiae
1090949|NCT00587041|O2|Outcome|Oxadrop|Participants received Oxadrop for 6 weeks: Oxadrop 1 packet daily plus 1 placebo capsule twice daily. Each gram of Oxadrop® contains 2x1011 bacteria (L. acidophilus, L. brevis, S. thermophilus, and B. infantis)
1090950|NCT00587041|O1|Outcome|Placebo|Participants received placebo for 6 weeks: 1 placebo packet daily and 1 placebo capsule twice daily
1090951|NCT00587041|E3|Reported Event|Placebo|Participants received placebo for 6 weeks: 1 placebo packet daily and 1 placebo capsule twice daily
1090952|NCT00587041|E2|Reported Event|Oxadrop|Participants received Oxadrop for 6 weeks: Oxadrop 1 packet daily plus 1 placebo capsule twice daily. Each gram of Oxadrop® contains 2x1011 bacteria (L. acidophilus, L. brevis, S. thermophilus, and B. infantis)
1090953|NCT00587041|E1|Reported Event|Agri-King Synbiotic|Participants received AKSB for 6 weeks: AKSB 1 capsule twice daily plus 1 placebo packet daily. AKSB contains Fructo-oligosaccharide; Enterococcus faecium (SF68); Saccharomyces cerevisiae subspecies Boulardi; and Saccharomyces cerevisiae
1090954|NCT00586898|B1|Baseline|All Participants|Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer
1090955|NCT00586898|P1|Participant Flow|All Participants|Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer
1090956|NCT00586898|O1|Outcome|All Participants|Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer
1090957|NCT00586898|E1|Reported Event|All Participants|Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer
1090958|NCT00586846|B1|Baseline|All Patients|Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
1090959|NCT00586846|P1|Participant Flow|All Patients|Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
1090960|NCT00586846|O1|Outcome|All Patients|Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
1090961|NCT00586846|E1|Reported Event|All Patients|Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
1090962|NCT00586820|B3|Baseline|Total|Total of all reporting groups
1090963|NCT00586820|B2|Baseline|Placebo|Subjects randomized to the placebo arm will receive a placebo infusion (saline) for 20 minutes prior to PCI.
1090964|NCT00586820|B1|Baseline|BQ-123|BQ-123 will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI).
1090965|NCT00586820|P2|Participant Flow|Placebo|Subjects randomized to the placebo arm will receive a placebo infusion (saline) for 20 minutes prior to PCI.
1090966|NCT00586820|P1|Participant Flow|BQ-123|The selective endothelin type A receptor antagonist (BQ-123) will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI).
1090967|NCT00586820|O2|Outcome|Placebo|Subjects randomized to the placebo arm will receive a placebo infusion (saline) for 20 minutes prior to PCI.
1090968|NCT00586820|O1|Outcome|BQ-123|BQ-123 will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI).
1090969|NCT00586820|O2|Outcome|Placebo|Subjects randomized to the placebo arm will receive a placebo infusion (saline) for 20 minutes prior to PCI.
1090970|NCT00586820|O1|Outcome|BQ-123|BQ-123 will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI).
1090971|NCT00586820|E2|Reported Event|Placebo|Subjects randomized to the placebo arm will receive a placebo infusion for 20 minutes prior to PCI.
1090972|NCT00586820|E1|Reported Event|BQ-123|BQ-123 will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI).
1090973|NCT00586729|B3|Baseline|Total|Total of all reporting groups
1090974|NCT00586729|B2|Baseline|5% Mafenide Acetate|5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
1090975|NCT00586729|B1|Baseline|Vashe|Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
1091333|NCT00586196|O1|Outcome|Donepezil : 5 mg Each Day for 30 Days|donepezil : 5 mg each day for 30 days
1090977|NCT00586729|P1|Participant Flow|Vashe|Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
1090978|NCT00586729|O2|Outcome|5% Mafenide Acetate|5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
1090979|NCT00586729|O1|Outcome|Vashe|Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
1090980|NCT00586729|O2|Outcome|5% Mafenide Acetate|5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
1090981|NCT00586729|O1|Outcome|Vashe|Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
1090982|NCT00586729|O2|Outcome|5% Mafenide Acetate|5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
1090983|NCT00586729|O1|Outcome|Vashe|Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
1090984|NCT00586729|E2|Reported Event|5% Mafenide Acetate|5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
1090985|NCT00586729|E1|Reported Event|Vashe|Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
1090986|NCT00586716|B3|Baseline|Total|Total of all reporting groups
1090987|NCT00586716|B2|Baseline|IVIG With Living Donor|Intravenous immune globulin for patients who have living donors with positive crossmatch results.
1090988|NCT00586716|B1|Baseline|IVIG no Living Donor|Intravenous immunoglobulin for: patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list
1090989|NCT00586716|P2|Participant Flow|Group 2 Intravenous Immune Globulin With Living Donor|"Patients who have living donors with positive crossmatch results.~intravenous immune globulins : 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments"
1090990|NCT00586716|P1|Participant Flow|Group 1 Intravenous Immune Globulin no Living Donor|"Patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list~intravenous immune globulins : 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments"
1090991|NCT00586716|O2|Outcome|Group 2 Intravenous Immune Globulin|"Intravenous immune globulin for patients who have living donors with positive crossmatch results.~intravenous immune globulin: 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments"
1090992|NCT00586716|O1|Outcome|Group 1 Intravenous Immune Globulin|"Intravenous immunoglobulin for: patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list~intravenous immune globulin: 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments"
1090993|NCT00586716|O1|Outcome|Intravenous Immune Globulin|Intravenous immune globulin for patients who have living donors with positive crossmatch results
1090994|NCT00586716|E2|Reported Event|Group 2 Intravenous Immune Globulin|Group 2 intravenous immune globulin WITH living donor
1090995|NCT00586716|E1|Reported Event|Group 1 Intravenous Immune Globulin|Group 1 with Intravenous immune globulin with no living donor
1090996|NCT00586703|B1|Baseline|Experimental: NK-CD56|"Natural Killer (NK) Cell infusion using CD56 monoclonal antibody following nonmyeloablative stem cell transplant (SCT) from mismatched donors~NK Cell Infusion following SCT from mismatched donors: The cells from leukapheresis will be NK selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft-versus host disease (aGVHD) at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion."
1090997|NCT00586703|P1|Participant Flow|Experimental: NK-CD56|"NK Cell infusion using CD56 monoclonal antibody following nonmyeloablative SCT from mismatched donors~NK Cell Infusion following SCT from mismatched donors : The cells from leukapheresis will be NK selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II aGVHD at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion."
1090998|NCT00586703|O1|Outcome|Experimental: NK-CD56|"Natural Killer (NK) Cell infusion using CD56 monoclonal antibody following nonmyeloablative stem cell transplant (SCT) from mismatched donors~NK Cell Infusion following SCT from mismatched donors: The cells from leukapheresis will be NK selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft-versus host disease (aGVHD) at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion."
1090999|NCT00586703|O1|Outcome|Experimental: NK-CD56|"Natural Killer (NK) Cell infusion using CD56 monoclonal antibody following nonmyeloablative stem cell transplant (SCT) from mismatched donors~NK Cell Infusion following SCT from mismatched donors: The cells from leukapheresis will be NK selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft-versus host disease (aGVHD) at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion."
1091015|NCT00586664|P3|Participant Flow|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091334|NCT00586196|E2|Reported Event|Placebo : Encapsulated Cornstarch|Placebo : Encapsulated cornstarch One capsule daily for 30 days
1091000|NCT00586703|E1|Reported Event|Experimental: NK-CD56|"Natural Killer (NK) Cell infusion using CD56 monoclonal antibody following nonmyeloablative stem cell transplant (SCT) from mismatched donors~NK Cell Infusion following SCT from mismatched donors: The cells from leukapheresis will be NK selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft-versus host disease (aGVHD) at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion."
1091001|NCT00586690|B3|Baseline|Total|Total of all reporting groups
1091002|NCT00586690|B2|Baseline|Donor Apheresis|Apheresis repeated daily up to 3 days until target dose of cells reached (preferably without donor receiving growth factors). Cells were transfused immediately after collection and processing. If collections occurred during initial mobilization at the time of stem cell transplant, the donor was off growth factor for >24 hours. These extra cell collections from the donor were sufficient for the natural killer cells used in the trial. The cells were NK selected using a CD56 antibody (CliniMACS CD56 Reagent), CliniMACSplus instrument and CliniMACS tubing set provided by Miltenyi Biotec using the company protocol (Miltenyi Biotec Inc, Auburn, California). Pre and post processing cell count, viability, Hematopoietic Progenitor Cell Assay (HPCA) and flow analysis were done.
1091003|NCT00586690|B1|Baseline|NK Cell Infusion|Natural Killer (NK) Cell infusion using CD56 monoclonal antibody: The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion.
1091004|NCT00586690|P2|Participant Flow|Donor Apheresis|Leukapheresis was repeated daily up to 3 days until the target dose of cells was reached (preferably without donor receiving growth factors). When possible, cells were transfused immediately after collection and processing. If collections occurred during initial mobilization at the time of stem cell transplant, the donor was off growth factor for >24 hours. These collections, which are extra cells collected from the donor following initial collections for transplant were sufficient for the natural killer cells used in the trial. The cells were NK selected using a CD56 antibody (CliniMACS CD56 Reagent), CliniMACSplus instrument and CliniMACS tubing set provided by Miltenyi Biotec using the company protocol (Miltenyi Biotec Inc, Auburn, California). Pre and post processing cell count, viability, Hematopoietic Progenitor Cell Assay (HPCA) and flow analysis were done.
1091005|NCT00586690|P1|Participant Flow|NK Cell Infusion|NK Cell infusion using CD56 monoclonal antibody: The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion.
1091006|NCT00586690|O1|Outcome|NK Cell Infusion|Natural Killer (NK) Cell infusion using CD56 monoclonal antibody: The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion.
1091007|NCT00586690|O1|Outcome|NK Cell Infusion|Natural Killer (NK) Cell infusion using CD56 monoclonal antibody: The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion.
1091008|NCT00586690|O1|Outcome|NK Cell Infusion|Natural Killer (NK) Cell infusion using CD56 monoclonal antibody: The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion.
1091009|NCT00586690|O1|Outcome|NK Cell Infusion|"Natural Killer (NK) Cell infusion using CD56 monoclonal antibody:~The cells from leukapheresis will be NK cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion."
1091010|NCT00586690|E1|Reported Event|NK Cell Infusion|Natural Killer (NK) Cell infusion using CD56 monoclonal antibody: The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion.
1091011|NCT00586664|B4|Baseline|Total|Total of all reporting groups
1091012|NCT00586664|B3|Baseline|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091013|NCT00586664|B2|Baseline|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091014|NCT00586664|B1|Baseline|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091335|NCT00586196|E1|Reported Event|Donepezil : 5 mg Each Day for 30 Days|donepezil : 5 mg each day for 30 days
1091016|NCT00586664|P2|Participant Flow|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091017|NCT00586664|P1|Participant Flow|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091018|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091019|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091020|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091021|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091022|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091023|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091024|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091025|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091026|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091027|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091028|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091029|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091030|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091031|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091032|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091033|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091034|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091035|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091036|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091037|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091038|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091039|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091040|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091041|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091042|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091043|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091044|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091045|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091046|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091047|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091048|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091049|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1092155|NCT00582660|P1|Participant Flow|Celecoxib|400 mg BID given for 7 days before surgery
1091418|NCT00585715|B3|Baseline|Total|Total of all reporting groups
1091050|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091051|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091052|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091053|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091054|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091055|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091056|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091057|NCT00586664|E3|Reported Event|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091058|NCT00586664|E2|Reported Event|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091059|NCT00586664|E1|Reported Event|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1091060|NCT00586625|B3|Baseline|Total|Total of all reporting groups
1091061|NCT00586625|B2|Baseline|Placebo (Vehicle)|One drop, both eyes, twice a day for six weeks
1091062|NCT00586625|B1|Baseline|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|One drop, both eyes, twice a day for six weeks
1091063|NCT00586625|P2|Participant Flow|Placebo (Vehicle)|One drop, both eyes, twice a day for six weeks
1091064|NCT00586625|P1|Participant Flow|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|One drop, both eyes, twice a day for six weeks
1091065|NCT00586625|O2|Outcome|Placebo (Vehicle)|One drop, both eyes, twice a day for six weeks
1091066|NCT00586625|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|One drop, both eyes, twice a day for six weeks
1091067|NCT00586625|E2|Reported Event|Placebo (Vehicle)|One drop, both eyes, twice a day for six weeks
1091068|NCT00586625|E1|Reported Event|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|One drop, both eyes, twice a day for six weeks
1091069|NCT00586612|B3|Baseline|Total|Total of all reporting groups
1091070|NCT00586612|B2|Baseline|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091071|NCT00586612|B1|Baseline|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091072|NCT00586612|P2|Participant Flow|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091073|NCT00586612|P1|Participant Flow|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091074|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091075|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091076|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091077|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091078|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091079|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091080|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091081|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091156|NCT00586495|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
1091082|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091083|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091084|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091085|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091086|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091087|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091088|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091089|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091090|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091091|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091092|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091093|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091094|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091095|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091096|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091097|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091098|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091099|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091100|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091101|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091102|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091103|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091104|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091157|NCT00586495|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
1091105|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091106|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091107|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091108|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091109|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091110|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091111|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091112|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091113|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091114|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091115|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091116|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091117|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091118|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091119|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091120|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091121|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091122|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091123|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091124|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091125|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091126|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091127|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091323|NCT00586261|E2|Reported Event|Placebo|Placebo 30 mg daily for six months
1091324|NCT00586261|E1|Reported Event|Pioglitazone|Pioglitazone 30 mg daily for six months
1091128|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091129|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091130|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091131|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091132|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091133|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091134|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091135|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091136|NCT00586612|E2|Reported Event|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091137|NCT00586612|E1|Reported Event|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
1091138|NCT00586573|B1|Baseline|Memantine|5-20 mg, twice daily, by mouth, 12 weeks
1091139|NCT00586573|P1|Participant Flow|Memantine|5-20 mg, twice daily, by mouth, 12 weeks
1091140|NCT00586573|O1|Outcome|Memantine|5-20 mg, twice daily, by mouth, 12 weeks
1091141|NCT00586573|E1|Reported Event|Memantine|5-20 mg, twice daily, by mouth, 12 weeks
1091142|NCT00586521|B1|Baseline|rFVIII-FS (Octocog-alfa), (Kogenate FS)|On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
1091143|NCT00586521|P1|Participant Flow|rFVIII-FS (Octocog-alfa), (Kogenate FS)|On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
1091144|NCT00586521|O1|Outcome|rFVIII-FS (Octocog-alfa), (Kogenate FS)|On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
1091145|NCT00586521|O1|Outcome|rFVIII-FS (Octocog-alfa), (Kogenate FS)|On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
1091146|NCT00586521|O1|Outcome|rFVIII-FS (Octocog-alfa), (Kogenate FS)|On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
1091147|NCT00586521|O1|Outcome|rFVIII-FS (Octocog-alfa), (Kogenate FS)|On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
1091148|NCT00586521|E1|Reported Event|rFVIII-FS (Octocog-alfa), (Kogenate FS)|On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
1091149|NCT00586495|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
1091150|NCT00586495|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
1091151|NCT00586495|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
1091152|NCT00586495|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
1091153|NCT00586495|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
1091154|NCT00586495|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
1091155|NCT00586495|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
1091325|NCT00586196|B3|Baseline|Total|Total of all reporting groups
1091158|NCT00586495|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
1091159|NCT00586482|B3|Baseline|Total|Total of all reporting groups
1091160|NCT00586482|B2|Baseline|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
1091161|NCT00586482|B1|Baseline|Nicotine Lozenges|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
1091162|NCT00586482|P2|Participant Flow|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
1091163|NCT00586482|P1|Participant Flow|Nicotine Lozenges|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
1091164|NCT00586482|O2|Outcome|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
1091165|NCT00586482|O1|Outcome|Nicotine Lozenges|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
1091166|NCT00586482|O2|Outcome|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
1091167|NCT00586482|O1|Outcome|Nicotine Lozenges|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
1091168|NCT00586482|O2|Outcome|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
1091169|NCT00586482|O1|Outcome|Nicotine Lozenges|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
1091170|NCT00586482|O2|Outcome|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
1091171|NCT00586482|O1|Outcome|Nicotine Lozenges|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
1091172|NCT00586482|O2|Outcome|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
1091173|NCT00586482|O1|Outcome|Nicotine Lozenges|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
1091174|NCT00586482|E2|Reported Event|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
1091175|NCT00586482|E1|Reported Event|Nicotine Lozenge|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
1091176|NCT00586469|B3|Baseline|Total|Total of all reporting groups
1091177|NCT00586469|B2|Baseline|New Bulk|This group received a full dose of Fluviral made from new material
1091178|NCT00586469|B1|Baseline|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
1091179|NCT00586469|P2|Participant Flow|New Bulk|This group received a full dose of Fluviral made from new material
1091180|NCT00586469|P1|Participant Flow|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
1091181|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
1091182|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
1091183|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
1091184|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
1091185|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
1091186|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
1091187|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
1091188|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
1091189|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
1091190|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
1091191|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
1091192|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
1091193|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
1091194|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
1091195|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
1091196|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
1091197|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
1091198|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
1091199|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
1091200|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
1091201|NCT00586469|E2|Reported Event|New Bulk|This group received a full dose of Fluviral made from new material
1091202|NCT00586469|E1|Reported Event|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
1091203|NCT00586339|B4|Baseline|Total|Total of all reporting groups
1091204|NCT00586339|B3|Baseline|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091205|NCT00586339|B2|Baseline|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091206|NCT00586339|B1|Baseline|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091207|NCT00586339|P3|Participant Flow|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091208|NCT00586339|P2|Participant Flow|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091209|NCT00586339|P1|Participant Flow|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091326|NCT00586196|B2|Baseline|Placebo : Encapsulated Cornstarch|Placebo : Encapsulated cornstarch One capsule daily for 30 days
1172370|NCT00381303|O2|Outcome|Male|
1091210|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091211|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091212|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091213|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091214|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091215|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091216|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091217|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091218|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091219|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091220|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091221|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091222|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091223|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091224|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091225|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091226|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091227|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091228|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091229|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091230|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091327|NCT00586196|B1|Baseline|Donepezil : 5 mg Each Day for 30 Days|donepezil : 5 mg each day for 30 days
1094448|NCT00577135|O4|Outcome|High Intensification|
1091231|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091232|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091233|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091234|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091235|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091236|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091237|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091238|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091239|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091240|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091241|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091242|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091243|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091244|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091245|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091246|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091247|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091248|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091249|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091250|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091251|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091328|NCT00586196|P2|Participant Flow|Placebo : Encapsulated Cornstarch|Placebo : Encapsulated cornstarch One capsule daily for 30 days
1172371|NCT00381303|O1|Outcome|Female|
1091252|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091253|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091254|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091255|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091256|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091257|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091258|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091259|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091260|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091261|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091262|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091263|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091264|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091265|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091266|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091267|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091268|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091269|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091270|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091271|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091272|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091329|NCT00586196|P1|Participant Flow|Donepezil : 5 mg Each Day for 30 Days|donepezil : 5 mg each day for 30 days
1094449|NCT00577135|O3|Outcome|Low Intensification|
1091273|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091274|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091275|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091276|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091277|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091278|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091279|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091280|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091281|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091282|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091283|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091284|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091285|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091286|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091287|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091288|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091289|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091290|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091291|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091292|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091293|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091330|NCT00586196|O2|Outcome|Placebo : Encapsulated Cornstarch|Placebo : Encapsulated cornstarch One capsule daily for 30 days
1172372|NCT00381303|O5|Outcome|Other|
1091294|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091295|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091296|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091297|NCT00586339|E3|Reported Event|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091298|NCT00586339|E2|Reported Event|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091299|NCT00586339|E1|Reported Event|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
1091300|NCT00586326|B1|Baseline|Treated|Subjects enrolled with device placed and treated with partial breast irradiation
1091301|NCT00586326|P1|Participant Flow|Enrolled|Women with DCIS who were willing to enroll and consented
1091302|NCT00586326|O4|Outcome|Poor|Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Poor' at 5 years
1091303|NCT00586326|O3|Outcome|Fair|Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Fair' at 5 years
1091304|NCT00586326|O2|Outcome|Good|Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Good' at 5 years
1091305|NCT00586326|O1|Outcome|Excellent|Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Excellent' at 5 years
1091306|NCT00586326|O1|Outcome|Treated|Subjects enrolled with device placed and treated with partial breast irradiation
1091307|NCT00586326|O1|Outcome|Treated|Subjects enrolled with device placed and treated with partial breast irradiation
1091308|NCT00586326|O1|Outcome|Treated|Subjects enrolled with device placed and treated with partial breast irradiation
1091309|NCT00586326|O1|Outcome|Treated|Subjects enrolled with device placed and treated with partial breast irradiation
1091310|NCT00586326|E1|Reported Event|Intent to Treat|Enrolled subjects with MammoSite device placed
1091311|NCT00586313|B1|Baseline|Participants Undergoing the Tru-Cut Biopsy|"Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples.~EUS Tru-cut biopsy: Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples. This technique may be particularly helpful to obtain liver biopsies in patients with morbid obesity or patients in whom there is no obtainable view to obtain a percutaneous biopsy."
1091312|NCT00586313|P1|Participant Flow|EUS Tru-cut Biopsy|"Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples.~EUS Tru-cut biopsy: Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples. This technique may be particularly helpful to obtain liver biopsies in patients with morbid obesity or patients in whom there is no obtainable view to obtain a percutaneous biopsy."
1091313|NCT00586313|O1|Outcome|EUS Tru-cut Biopsy|"Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples.~EUS Tru-cut biopsy: Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples. This technique may be particularly helpful to obtain liver biopsies in patients with morbid obesity or patients in whom there is no obtainable view to obtain a percutaneous biopsy."
1091314|NCT00586313|O1|Outcome|EUS Tru-cut Biopsy|"Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples.~EUS Tru-cut biopsy: Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples. This technique may be particularly helpful to obtain liver biopsies in patients with morbid obesity or patients in whom there is no obtainable view to obtain a percutaneous biopsy."
1091315|NCT00586313|E1|Reported Event|EUS Tru-cut Biopsy|"Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples.~EUS Tru-cut biopsy: Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples. This technique may be particularly helpful to obtain liver biopsies in patients with morbid obesity or patients in whom there is no obtainable view to obtain a percutaneous biopsy."
1091316|NCT00586261|B3|Baseline|Total|Total of all reporting groups
1091317|NCT00586261|B2|Baseline|Placebo Arm|"study the specific dose of placebo 30 mg daily for 6 months~placebo : placebo 30 mg daily for 6 months"
1091318|NCT00586261|B1|Baseline|Pioglitazone Arm|"study the specific dose of pioglitazone 30 mg daily for 6 months~pioglitazone : pioglitazone 30 mg daily for 6 months"
1091319|NCT00586261|P2|Participant Flow|Placebo|Placebo 30 mg daily for 6 months
1091320|NCT00586261|P1|Participant Flow|Pioglitazone|Pioglitazone 30 mg daily for 6 months
1091321|NCT00586261|O2|Outcome|Placebo Arm|"study the specific dose of placebo 30 mg daily for 6 months~placebo : placebo 30 mg daily for 6 months"
1091322|NCT00586261|O1|Outcome|Pioglitazone Arm|"study the specific dose of pioglitazone 30 mg daily for 6 months~pioglitazone : pioglitazone 30 mg daily for 6 months"
1172373|NCT00381303|O4|Outcome|Asian|
1091348|NCT00586157|P2|Participant Flow|Placebo Then MTS|Placebo in first intervention then MTS in second intervention
1091349|NCT00586157|P1|Participant Flow|MTS Then Placebo|MTS in first intervention then Placebo in second intervention
1091350|NCT00586157|O2|Outcome|Placebo|
1091351|NCT00586157|O1|Outcome|MTS (Drug A)|
1091352|NCT00586157|O2|Outcome|Placebo|
1091353|NCT00586157|O1|Outcome|MTS (Drug A)|
1091354|NCT00586157|O2|Outcome|Placebo|
1091355|NCT00586157|O1|Outcome|MTS (Drug A)|
1091356|NCT00586157|E2|Reported Event|Placebo|
1091357|NCT00586157|E1|Reported Event|MTS (Drug A)|
1091358|NCT00586105|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
1091359|NCT00586105|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
1091360|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
1091361|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
1091362|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
1091363|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
1091364|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
1091365|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
1091366|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
1091367|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
1091368|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
1091369|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
1091370|NCT00586105|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
1091371|NCT00586066|B3|Baseline|Total|Total of all reporting groups
1091372|NCT00586066|B2|Baseline|Placebo|Placebo-matching memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to placebo-matching memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to placebo-matching memantine 5 mg in the morning and placebo-matching memantine 10 mg in the evening in Week 3; dose increase if tolerated to placebo-matching memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
1091373|NCT00586066|B1|Baseline|Memantine|Memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to memantine 5 mg in the morning and memantine 10 mg in the evening in Week 3; dose increase if tolerated to memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
1091374|NCT00586066|P2|Participant Flow|Placebo|Placebo-matching memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to placebo-matching memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to placebo-matching memantine 5 mg in the morning and placebo-matching memantine 10 mg in the evening in Week 3; dose increase if tolerated to placebo-matching memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
1091375|NCT00586066|P1|Participant Flow|Memantine|Memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to memantine 5 mg in the morning and memantine 10 mg in the evening in Week 3; dose increase if tolerated to memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
1091376|NCT00586066|O2|Outcome|Placebo|Placebo-matching memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to placebo-matching memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to placebo-matching memantine 5 mg in the morning and placebo-matching memantine 10 mg in the evening in Week 3; dose increase if tolerated to placebo-matching memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
1091377|NCT00586066|O1|Outcome|Memantine|Memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to memantine 5 mg in the morning and memantine 10 mg in the evening in Week 3; dose increase if tolerated to memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
1091378|NCT00586066|O2|Outcome|Placebo|Placebo-matching memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to placebo-matching memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to placebo-matching memantine 5 mg in the morning and placebo-matching memantine 10 mg in the evening in Week 3; dose increase if tolerated to placebo-matching memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
1091379|NCT00586066|O1|Outcome|Memantine|Memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to memantine 5 mg in the morning and memantine 10 mg in the evening in Week 3; dose increase if tolerated to memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
1091380|NCT00586066|O2|Outcome|Placebo|Placebo-matching memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to placebo-matching memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to placebo-matching memantine 5 mg in the morning and placebo-matching memantine 10 mg in the evening in Week 3; dose increase if tolerated to placebo-matching memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
1091381|NCT00586066|O1|Outcome|Memantine|Memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to memantine 5 mg in the morning and memantine 10 mg in the evening in Week 3; dose increase if tolerated to memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
1091419|NCT00585715|B2|Baseline|Laser Without Cooling|Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
1091382|NCT00586066|E2|Reported Event|Placebo|Placebo-matching memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to placebo-matching memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to placebo-matching memantine 5 mg in the morning and placebo-matching memantine 10 mg in the evening in Week 3; dose increase if tolerated to placebo-matching memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
1091383|NCT00586066|E1|Reported Event|Memantine|Memantine 5 mg tablet once per day for 1 week; dose increase if tolerated to memantine 5 mg twice a day, in the morning and the evening in Week 2; dose increase if tolerated to memantine 5 mg in the morning and memantine 10 mg in the evening in Week 3; dose increase if tolerated to memantine 10 mg twice a day, in the morning and the evening Weeks 4 to 12.
1091384|NCT00585975|B3|Baseline|Total|Total of all reporting groups
1091385|NCT00585975|B2|Baseline|Xibrom 0.09%|
1091386|NCT00585975|B1|Baseline|Bromfenac Ophthalmic Solution 0.18%|
1091387|NCT00585975|P2|Participant Flow|Xibrom 0.09%|
1091388|NCT00585975|P1|Participant Flow|Bromfenac Ophthalmic Solution 0.18%|
1091389|NCT00585975|O2|Outcome|Xibrom 0.09%|
1091390|NCT00585975|O1|Outcome|Bromfenac Ophthalmic Solution 0.18%|
1091391|NCT00585975|O2|Outcome|Xibrom 0.09%|
1091392|NCT00585975|O1|Outcome|Bromfenac Ophthalmic Solution 0.18%|
1091393|NCT00585975|E2|Reported Event|Xibrom 0.09%|
1091394|NCT00585975|E1|Reported Event|Bromfenac Ophthalmic Solution 0.18%|
1091395|NCT00585923|B3|Baseline|Total|Total of all reporting groups
1091396|NCT00585923|B2|Baseline|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
1091397|NCT00585923|B1|Baseline|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
1091398|NCT00585923|P2|Participant Flow|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
1091399|NCT00585923|P1|Participant Flow|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
1091400|NCT00585923|O2|Outcome|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
1091401|NCT00585923|O1|Outcome|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
1091402|NCT00585923|O2|Outcome|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
1091403|NCT00585923|O1|Outcome|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
1091404|NCT00585923|O2|Outcome|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
1091405|NCT00585923|O1|Outcome|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
1091406|NCT00585923|O2|Outcome|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
1091407|NCT00585923|O1|Outcome|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
1091408|NCT00585923|O2|Outcome|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
1091409|NCT00585923|O1|Outcome|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
1091410|NCT00585923|E2|Reported Event|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
1091411|NCT00585923|E1|Reported Event|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
1091436|NCT00585650|P2|Participant Flow|Subjects Receiving Placebo for the First 12 Weeks|Subjects randomized placebo injection for first 12 weeks. All subjects receiving placebo were then crossed over to etanercept 50mg twice weekly for another 12 weeks. An additional follow-up visit was performed on week 28.
1091437|NCT00585650|P1|Participant Flow|Subjects Receiving Etanercept 50 mg Twice Week for 12 Weeks|Subjects randomized to use etanercept 50mg twice weekly for 12 weeks. An additional follow-up visit was performed on week 28.
1091412|NCT00585910|B1|Baseline|Overall Study|Atomoxetine (ATMX) treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate (OROS MPH) will then be added to his or her treatment regimen for the final 3 weeks of the study. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
1091413|NCT00585910|P1|Participant Flow|Overall Study|Atomoxetine (ATMX) treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate (OROS MPH) will then be added to his or her treatment regimen for the final 3 weeks of the study. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
1091414|NCT00585910|O1|Outcome|Overall Study|Atomoxetine (ATMX) treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate (OROS MPH) will then be added to his or her treatment regimen for the final 3 weeks of the study. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
1091415|NCT00585910|O1|Outcome|Overall Study|Atomoxetine (ATMX) treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate (OROS MPH) will then be added to his or her treatment regimen for the final 3 weeks of the study. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
1091416|NCT00585910|E2|Reported Event|ATMX and OROS MPH|Partial responders to ATMX alone entered into the ATMX and OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
1091417|NCT00585910|E1|Reported Event|ATMX Only|Atomoxetine treatment will be initiated and maintained for 4 weeks. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase.
1091420|NCT00585715|B1|Baseline|Laser With Cooling|Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
1091421|NCT00585715|P2|Participant Flow|Laser Without Cooling|Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
1091422|NCT00585715|P1|Participant Flow|Laser With Cooling|Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
1091423|NCT00585715|O2|Outcome|Laser Without Cooling for Skin Tightening|Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
1091424|NCT00585715|O1|Outcome|Laser With Cooling for Skin Tightening|Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
1091425|NCT00585715|O2|Outcome|Laser Without Cooling for Skin Tightening|Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
1091426|NCT00585715|O1|Outcome|Laser With Cooling for Skin Tightening|Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
1091427|NCT00585715|E2|Reported Event|Laser Without Cooling|Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
1091428|NCT00585715|E1|Reported Event|Laser With Cooling|Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
1091429|NCT00585689|B1|Baseline|Neoadjuvant ABI-007, Carboplatin, and Gemcitabine|Neoadjuvant ABI-007 (260 mg/m^2) on day 1, Carboplatin (Target AUC [Area under the curve] =5) on day 1, and Gemcitabine (800 mg^m2) on days 1 and 8, every 21 days.
1091430|NCT00585689|P1|Participant Flow|Neoadjuvant ABI-007, Carboplatin, and Gemcitabine|Neoadjuvant ABI-007 (260 mg/m^2) on day 1, Carboplatin (Target AUC [Area under the curve] =5) on day 1, and Gemcitabine (800 mg^m2) on days 1 and 8, every 21 days.
1091431|NCT00585689|O1|Outcome|Neoadjuvant ABI-007, Carboplatin, and Gemcitabine|Neoadjuvant ABI-007 (260 mg/m^2) on day 1, Carboplatin (Target AUC [Area under the curve] =5) on day 1, and Gemcitabine (800 mg^m2) on days 1 and 8, every 21 days.
1091432|NCT00585689|E1|Reported Event|Neoadjuvant ABI-007, Carboplatin, and Gemcitabine|Neoadjuvant ABI-007 (260 mg/m^2) on day 1, Carboplatin (Target AUC [Area under the curve] =5) on day 1, and Gemcitabine (800 mg^m2) on days 1 and 8, every 21 days.
1091433|NCT00585650|B3|Baseline|Total|Total of all reporting groups
1091434|NCT00585650|B2|Baseline|Subjects Receiving Placebo for the First 12 Weeks|Subjects randomized placebo injection for first 12 weeks. All subjects receiving placebo were then crossed over to etanercept 50mg twice weekly for another 12 weeks. An additional follow-up visit was performed on week 28.
1091435|NCT00585650|B1|Baseline|Subjects Receiving Etanercept 50 mg Twice Week for 12 Weeks|Subjects randomized to use etanercept 50mg twice weekly for 12 weeks. An additional follow-up visit was performed on week 28.
1091438|NCT00585650|O2|Outcome|Subjects Receiving Placebo for the First 12 Weeks|Subjects randomized placebo injection for first 12 weeks. All subjects receiving placebo were then crossed over to etanercept 50mg twice weekly for another 12 weeks. An additional follow-up visit was performed on week 28.
1091439|NCT00585650|O1|Outcome|Subjects Receiving Etanercept 50 mg Twice Week for 12 Weeks|Subjects randomized to use etanercept 50mg twice weekly for 12 weeks. An additional follow-up visit was performed on week 28.
1091440|NCT00585650|E2|Reported Event|Subjects Receiving Placebo for the First 12 Weeks|Subjects randomized placebo injection for first 12 weeks. All subjects receiving placebo were then crossed over to etanercept 50mg twice weekly for another 12 weeks. An additional follow-up visit was performed on week 28.
1091441|NCT00585650|E1|Reported Event|Subjects Receiving Etanercept 50 mg Twice Week for 12 Weeks|Subjects randomized to use etanercept 50mg twice weekly for 12 weeks. An additional follow-up visit was performed on week 28.
1091442|NCT00585637|B5|Baseline|Total|Total of all reporting groups
1091443|NCT00585637|B4|Baseline|4000 IU of Vitamin D|"4000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
1091444|NCT00585637|B3|Baseline|2000 IU of Vitamin D|"2000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
1091445|NCT00585637|B2|Baseline|1000 IU of Vitamin D|"1000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
1091446|NCT00585637|B1|Baseline|No Vitamin D|"No Vitamin D~Placebo: Placebo pill taken once daily for 3 month"
1091447|NCT00585637|P4|Participant Flow|4000 IU of Vitamin D|"4000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
1091448|NCT00585637|P3|Participant Flow|2000 IU of Vitamin D|"2000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
1091449|NCT00585637|P2|Participant Flow|1000 IU of Vitamin D|"1000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
1091450|NCT00585637|P1|Participant Flow|No Vitamin D|"No Vitamin D~Placebo: Placebo pill taken once daily for 3 month"
1091451|NCT00585637|O4|Outcome|4000 IU of Vitamin D|"4000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
1091452|NCT00585637|O3|Outcome|2000 IU of Vitamin D|"2000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
1091453|NCT00585637|O2|Outcome|1000 IU of Vitamin D|"1000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
1091454|NCT00585637|O1|Outcome|No Vitamin D|"No Vitamin D~Placebo: Placebo pill taken once daily for 3 month"
1091455|NCT00585637|O4|Outcome|4000 IU of Vitamin D|"4000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
1091456|NCT00585637|O3|Outcome|2000 IU of Vitamin D|"2000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
1091457|NCT00585637|O2|Outcome|1000 IU of Vitamin D|"1000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
1091458|NCT00585637|O1|Outcome|No Vitamin D|"No Vitamin D~Placebo: Placebo pill taken once daily for 3 month"
1091459|NCT00585637|O4|Outcome|4000 IU of Vitamin D|"4000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
1091460|NCT00585637|O3|Outcome|2000 IU of Vitamin D|"2000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
1091461|NCT00585637|O2|Outcome|1000 IU of Vitamin D|"1000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
1091462|NCT00585637|O1|Outcome|No Vitamin D|"No Vitamin D~Placebo: Placebo pill taken once daily for 3 month"
1091463|NCT00585637|O4|Outcome|4000 IU of Vitamin D|"4000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
1091464|NCT00585637|O3|Outcome|2000 IU of Vitamin D|"2000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
1091465|NCT00585637|O2|Outcome|1000 IU of Vitamin D|"1000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
1091466|NCT00585637|O1|Outcome|No Vitamin D|"No Vitamin D~Placebo: Placebo pill taken once daily for 3 month"
1091467|NCT00585637|O4|Outcome|4000 IU of Vitamin D|"4000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
1091468|NCT00585637|O3|Outcome|2000 IU of Vitamin D|"2000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
1091469|NCT00585637|O2|Outcome|1000 IU of Vitamin D|"1000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
1091470|NCT00585637|O1|Outcome|No Vitamin D|"No Vitamin D~Placebo: Placebo pill taken once daily for 3 month"
1091471|NCT00585637|E4|Reported Event|4000 IU of Vitamin D|"4000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
1091472|NCT00585637|E3|Reported Event|2000 IU of Vitamin D|"2000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
1091473|NCT00585637|E2|Reported Event|1000 IU of Vitamin D|"1000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
1091474|NCT00585637|E1|Reported Event|No Vitamin D|"No Vitamin D~Placebo: Placebo pill taken once daily for 3 month"
1091475|NCT00585533|B1|Baseline|All Participants|All participants enrolled in trial.
1091476|NCT00585533|P1|Participant Flow|All Participants|All participants enrolled in trial.
1091477|NCT00585533|O1|Outcome|All Participants|All participants enrolled in trial.
1091478|NCT00585533|O1|Outcome|All Participants|All participants enrolled in trial.
1091479|NCT00585533|E1|Reported Event|All Participants|All participants enrolled in trial.
1091480|NCT00585494|B1|Baseline|Preoperative Orthopedic|Patients undergoing elective total hip, knee and spinal surgery at UW hospital, having their preoperative visit between December 1, 2007 and November 30, 2008.
1091481|NCT00585494|P1|Participant Flow|Preoperative Orthopedic|Patients undergoing elective total hip, knee and spinal surgery at UW hospital, having their preoperative visit between December 1, 2007 and November 30, 2008.
1091482|NCT00585494|O1|Outcome|Preoperative Orthopedic|Patients undergoing elective total hip, knee and spinal surgery at UW hospital, having their preoperative visit between December 1, 2007 and November 30, 2008.
1091483|NCT00585494|E1|Reported Event|Preoperative Orthopedic|Patients undergoing elective total hip, knee and spinal surgery at UW hospital, having their preoperative visit between December 1, 2007 and November 30, 2008.
1091484|NCT00585468|B1|Baseline|Entire Study Population|Includes groups randomized to the Fed State first and to the Fasted State first
1091485|NCT00585468|P2|Participant Flow|Fasting State First, Then Fed State|720 mg mycophenolate sodium orally twice daily separated from food by 2 hours for one week in the first intervention period, followed by one week of 720 mg mycophenolate sodium orally twice daily with a meal in the second intervention period.
1172374|NCT00381303|O3|Outcome|Hispanic|
1091486|NCT00585468|P1|Participant Flow|Fed State First, Then Fasting State|720 milligrams (mg) mycophenolate sodium orally twice daily with a meal for one week in the first intervention period, followed by one week of 720 mg mycophenolate sodium orally twice daily separated by food by 2 hours in the second intervention period.
1091487|NCT00585468|O2|Outcome|Myfortic - Fasting State|"Mycophenolate sodium taken separately from food by 2 hours.~Myfortic: Myfortic 720 mg orally twice daily"
1091488|NCT00585468|O1|Outcome|Myfortic - Fed State|"Mycophenolate sodium taken with a meal.~Myfortic: Myfortic 720 mg orally twice daily"
1091489|NCT00585468|O2|Outcome|Myfortic - Fasting State|"Mycophenolate sodium taken separately from food by 2 hours.~Myfortic: Myfortic 720 mg orally twice daily"
1091490|NCT00585468|O1|Outcome|Myfortic - Fed State|"Mycophenolate sodium taken with a meal.~Myfortic: Myfortic 720 mg orally twice daily"
1091491|NCT00585468|O2|Outcome|Myfortic - Fasting State|"Mycophenolate sodium taken separately from food by 2 hours.~Myfortic: Myfortic 720 mg orally twice daily"
1091492|NCT00585468|O1|Outcome|Myfortic - Fed State|"Mycophenolate sodium taken with a meal.~Myfortic: Myfortic 720 mg orally twice daily"
1091493|NCT00585468|O2|Outcome|Myfortic - Fasting State|"Mycophenolate sodium taken separately from food by 2 hours.~Myfortic: Myfortic 720 mg orally twice daily"
1091494|NCT00585468|O1|Outcome|Myfortic - Fed State|"Mycophenolate sodium taken with a meal.~Myfortic: Myfortic 720 mg orally twice daily"
1091495|NCT00585468|O2|Outcome|Myfortic - Fasting State|"Mycophenolate sodium taken separately from food by 2 hours.~Myfortic: Myfortic 720 mg orally twice daily"
1091496|NCT00585468|O1|Outcome|Myfortic - Fed State|"Mycophenolate sodium taken with a meal.~Myfortic: Myfortic 720 mg orally twice daily"
1091497|NCT00585468|O2|Outcome|Myfortic - Fasting State|"Mycophenolate sodium taken separately from food by 2 hours.~Myfortic: Myfortic 720 mg orally twice daily"
1091498|NCT00585468|O1|Outcome|Myfortic - Fed State|"Mycophenolate sodium taken with a meal.~Myfortic: Myfortic 720 mg orally twice daily"
1091499|NCT00585468|O2|Outcome|Myfortic - Fasting State|"Mycophenolate sodium taken separately from food by 2 hours.~Myfortic: Myfortic 720 mg orally twice daily"
1091500|NCT00585468|O1|Outcome|Myfortic - Fed State|"Mycophenolate sodium taken with a meal.~Myfortic: Myfortic 720 mg orally twice daily"
1091501|NCT00585468|O2|Outcome|Myfortic - Fasting State|Mycophenolate sodium taken separately from food by 2 hours
1091502|NCT00585468|O1|Outcome|Myfortic - Fed State|Mycophenolate sodium taken with a meal
1091503|NCT00585468|E2|Reported Event|Myfortic - Fasting State|Mycophenolate sodium taken separately from food by 2 hours
1091504|NCT00585468|E1|Reported Event|Myfortic - Fed State|Mycophenolate sodium taken with a meal
1091505|NCT00585377|B1|Baseline|Arm 1|Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
1091567|NCT00585182|O1|Outcome|Enoxaparin 0.5mg/kg Once Daily|
1091506|NCT00585377|P1|Participant Flow|Arm 1:Bevacizumab and Erlotinib|Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
1091507|NCT00585377|O1|Outcome|Arm 1:Bevacizumab and Erlotinib|Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
1091508|NCT00585377|O1|Outcome|Arm 1:Bevacizumab and Erlotinib|Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
1091509|NCT00585377|O1|Outcome|Arm 1:Bevacizumab and Erlotinib|Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
1091510|NCT00585377|E1|Reported Event|Arm 1|Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
1091511|NCT00585351|B7|Baseline|Total|Total of all reporting groups
1091512|NCT00585351|B6|Baseline|No Advanced Notification + Placebo|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
1091513|NCT00585351|B5|Baseline|Advanced Notification + Placebo|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
1091514|NCT00585351|B4|Baseline|No Advanced Notification + Ranitidine|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
1091515|NCT00585351|B3|Baseline|Advanced Notification + Ranitidine|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
1091516|NCT00585351|B2|Baseline|No Advanced Notification + Consent +Not Eligible for Study Med|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
1091517|NCT00585351|B1|Baseline|Advanced Notification + Consent + Not Eligible for Study Med|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
1091518|NCT00585351|P8|Participant Flow|No Advanced Notification + Placebo|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until the Air Care helicopter crew has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
1091519|NCT00585351|P7|Participant Flow|Advanced Notification + Placebo|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of the Air Care helicopter crew to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
1091543|NCT00585312|O2|Outcome|Placebo|Matching placebo
1172375|NCT00381303|O2|Outcome|Caucasian|
1091520|NCT00585351|P6|Participant Flow|No Advanced Notification + Ranitidine|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until the Air Care helicopter crew has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
1091521|NCT00585351|P5|Participant Flow|Advanced Notification + Ranitidine|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of the Air Care helicopter crew to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
1091522|NCT00585351|P4|Participant Flow|No Advanced Notification + Consent +Not Eligible for Study Med|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until the Air Care helicopter crew has arrived to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
1091523|NCT00585351|P3|Participant Flow|Advanced Notification + Consent + Not Eligible for Study Med|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of the Air Care helicopter crew to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
1091524|NCT00585351|P2|Participant Flow|No Advanced Notification|Subjects in this group are randomized to not receiving any advanced notification about the study, so they are not provided the informed consent document until Air Care helicopter crew has arrived to the outside hospital where the subject is at.
1091525|NCT00585351|P1|Participant Flow|Advanced Notification|Subjects in this group are randomized to receiving advanced notification about the AIRDOC study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care helicopter crew to the outside hospital where the subject is at.
1091526|NCT00585351|O4|Outcome|No Advanced Notification + Placebo|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
1091527|NCT00585351|O3|Outcome|Advanced Notification + Placebo|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
1091568|NCT00585182|O1|Outcome|Enoxaparin 0.5mg/kg Once Daily|
1091528|NCT00585351|O2|Outcome|No Advanced Notification + Ranitidine|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
1091529|NCT00585351|O1|Outcome|Advanced Notification + Ranitidine|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
1091530|NCT00585351|O2|Outcome|No Advanced Notification|Subjects in this group are randomized to not receiving any advanced notification about the study, so they are not provided the informed consent document until Air Care helicopter crew has arrived to the outside hospital where the subject is at.
1091531|NCT00585351|O1|Outcome|Advanced Notification|Subjects in this group are randomized to receiving advanced notification about the AIRDOC study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care helicopter crew to the outside hospital where the subject is at.
1091532|NCT00585351|E6|Reported Event|No Advanced Notification + Placebo|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
1091533|NCT00585351|E5|Reported Event|Advanced Notification + Placebo|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
1091534|NCT00585351|E4|Reported Event|No Advanced Notification + Ranitidine|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
1091535|NCT00585351|E3|Reported Event|Advanced Notification + Ranitidine|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
1091536|NCT00585351|E2|Reported Event|No Advanced Notification + Consent +Not Eligible for Study Med|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
1091537|NCT00585351|E1|Reported Event|Advanced Notification + Consent + Not Eligible for Study Med|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
1091538|NCT00585312|B3|Baseline|Total|Total of all reporting groups
1091539|NCT00585312|B2|Baseline|Placebo|Matching placebo
1091540|NCT00585312|B1|Baseline|Celecoxib|Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
1091541|NCT00585312|P2|Participant Flow|Placebo|Matching placebo
1091542|NCT00585312|P1|Participant Flow|Celecoxib|Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
1172376|NCT00381303|O1|Outcome|Black|
1091544|NCT00585312|O1|Outcome|Celecoxib|Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
1091545|NCT00585312|O2|Outcome|Placebo|Matching placebo
1091546|NCT00585312|O1|Outcome|Celecoxib|Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
1091547|NCT00585312|O2|Outcome|Placebo|Matching placebo
1091548|NCT00585312|O1|Outcome|Celecoxib|Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
1091549|NCT00585312|O2|Outcome|Placebo|Matching placebo
1091550|NCT00585312|O1|Outcome|Celecoxib|Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
1091551|NCT00585312|E2|Reported Event|Placebo|Matching placebo
1091552|NCT00585312|E1|Reported Event|Celecoxib|Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
1091553|NCT00585286|B1|Baseline|Fractional CO2 Laser System|Thirty healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
1091554|NCT00585286|P1|Participant Flow|Fractional Carbon Dioxide Laser System|Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional carbon dioxide laser system.
1091555|NCT00585286|O1|Outcome|Fractional CO2 Laser System|Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
1091556|NCT00585286|O1|Outcome|Fractional CO2 Laser System|Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
1091557|NCT00585286|O1|Outcome|Fractional CO2 Laser System|Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
1091558|NCT00585286|O1|Outcome|Fractional CO2 Laser System|Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
1091559|NCT00585286|E1|Reported Event|Fractional CO2 Laser System|Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
1091560|NCT00585221|B1|Baseline|Group 1|
1091561|NCT00585221|P1|Participant Flow|All Patients|All participants enrolled.
1091562|NCT00585221|O1|Outcome|All Patients|All participants enrolled
1091563|NCT00585221|O1|Outcome|All Patients|All participants enrolled
1091564|NCT00585221|E1|Reported Event|All Enrolled|All participants enrolled
1091565|NCT00585182|B1|Baseline|Enoxaparin 0.5mg/kg Once Daily|
1091566|NCT00585182|P1|Participant Flow|Enoxaparin 0.5mg/kg Once Daily|
1091570|NCT00585169|B1|Baseline|Memantine|"10 to 30 mg/day memantine~Memantine Hydrochloride : 10 mg/day for two weeks, dose increase to 20 mg at week 3, 40 mg at week 5 unless clinical improvement is achieved with a lower dose. Total treatment is 10 weeks. Mean dose at study end was 23.4 ± 8.1 mg/day"
1091571|NCT00585169|P1|Participant Flow|Memantine|"10 to 30 mg/day memantine~Memantine Hydrochloride : 10 mg/day for two weeks, dose increase to 20 mg at week 3, 40 mg at week 5 unless clinical improvement is achieved with a lower dose. Total treatment is 10 weeks. Mean dose at study end was 23.4 ± 8.1 mg/day"
1091572|NCT00585169|O1|Outcome|Memantine|"10 to 30 mg/day memantine~Memantine Hydrochloride : 10 mg/day for two weeks, dose increase to 20 mg at week 3, 40 mg at week 5 unless clinical improvement is achieved with a lower dose. Total treatment is 10 weeks. Mean dose at study end was 23.4 ± 8.1 mg/day"
1091573|NCT00585169|E3|Reported Event|Memantine 30mg|
1091574|NCT00585169|E2|Reported Event|Memantine 20mg|
1091575|NCT00585169|E1|Reported Event|Memantine 10mg|
1091576|NCT00585104|B1|Baseline|Levosimendan, Compare Heart Function and Metabolism|All patients received Levosimendan (12mcg/kg IV bolus over 10 minutes, Abbott Laboratories, Abbott Park, IL). All study measurements occur at baseline and 30-minutes after the initiation of levosimendan.
1091577|NCT00585104|P1|Participant Flow|Levosimendan, Compare Heart Function and Metabolism|All patients received Levosimendan (12mcg/kg IV bolus over 10 minutes, Abbott Laboratories, Abbott Park, IL). All study measurements occur at baseline and 30-minutes after the initiation of levosimendan.
1091578|NCT00585104|O1|Outcome|Levosimendan, Compare Heart Function and Metabolism|All patients received Levosimendan (12mcg/kg IV bolus over 10 minutes, Abbott Laboratories, Abbott Park, IL). All study measurements occur at baseline and 30-minutes after the initiation of levosimendan.
1091579|NCT00585104|E1|Reported Event|Levosimendan, Compare Heart Function and Metabolism|All patients received Levosimendan (12mcg/kg IV bolus over 10 minutes, Abbott Laboratories, Abbott Park, IL). All study measurements occur at baseline and 30-minutes after the initiation of levosimendan.
1091580|NCT00585078|B1|Baseline|CAPOX|Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
1091581|NCT00585078|P1|Participant Flow|CAPOX|Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
1091582|NCT00585078|O1|Outcome|CAPOX|Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
1091611|NCT00585013|O2|Outcome|Placebo|Placebo delivery of oxygen at standard dose.
1091654|NCT00584948|B1|Baseline|Memantine|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.
1091583|NCT00585078|O1|Outcome|CAPOX|Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
1091584|NCT00585078|O1|Outcome|CAPOX|Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
1091585|NCT00585078|O1|Outcome|CAPOX|Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
1091586|NCT00585078|E1|Reported Event|CAPOX|Participants self-administered capecitabine 1,000 mg/m2 orally twice daily (total daily dose 2,000 mg/m2), days 1-14 in 21-day cycles. Only 500 mg tablets were used, and doses were rounded to the nearest dose that could be administered with 500 mg tablets. Oxaliplatin 130 mg/m2 was administered intravenously on day 1 every 21 (±2) days. Treatment continued until tumor progression or toxicity requiring discontinuation of therapy.
1091587|NCT00585039|B3|Baseline|Total|Total of all reporting groups
1091588|NCT00585039|B2|Baseline|Albuterol|patients who received 7.5 mg albuterol nebulization at baseline and could be repeated at 60 minutes
1091589|NCT00585039|B1|Baseline|Levalbuterol (Xopenex)|Patients who received 3.75 mg levalbuterol nebulization at baseline and could be repeated at 60 minutes
1091590|NCT00585039|P2|Participant Flow|Albuterol|patients who received 7.5 mg albuterol nebulization at baseline and could be repeated at 60 minutes
1091591|NCT00585039|P1|Participant Flow|Levalbuterol (Xopenex)|Patients who received 3.75 mg levalbuterol nebulization at baseline and could be repeated at 60 minutes
1091592|NCT00585039|O2|Outcome|Albuterol|
1091593|NCT00585039|O1|Outcome|Levalbuterol|
1091594|NCT00585039|O2|Outcome|Albuterol|patients who received 7.5 mg albuterol nebulization at baseline and could be repeated at 60 minutes
1091595|NCT00585039|O1|Outcome|Levalbuterol (Xopenex)|Patients who received 3.75 mg levalbuterol nebulization at baseline and could be repeated at 60 minutes
1091596|NCT00585039|E2|Reported Event|Albuterol|patients who received 7.5 mg albuterol nebulization at baseline and could be repeated at 60 minutes
1091712|NCT00584831|O1|Outcome|Lotrafilcon B|lotrafilcon b toric
1091597|NCT00585039|E1|Reported Event|Levalbuterol (Xopenex)|Patients who received 3.75 mg levalbuterol nebulization at baseline and could be repeated at 60 minutes
1091598|NCT00585013|B3|Baseline|Total|Total of all reporting groups
1091599|NCT00585013|B2|Baseline|2 Placebo|Placebo delivery of oxygen at standard dose.
1091600|NCT00585013|B1|Baseline|1 Treatment|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.~Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
1091601|NCT00585013|P2|Participant Flow|2 Placebo|Placebo delivery of oxygen at standard dose.
1091602|NCT00585013|P1|Participant Flow|1 Treatment|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.~Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
1091603|NCT00585013|O2|Outcome|2 Placebo|Placebo delivery of oxygen at standard dose.
1091604|NCT00585013|O1|Outcome|1 Treatment|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.~Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
1091605|NCT00585013|O2|Outcome|2 Placebo|Placebo delivery of oxygen at standard dose.
1091606|NCT00585013|O1|Outcome|1 Treatment|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.~Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
1091607|NCT00585013|O2|Outcome|2 Placebo|Placebo delivery of oxygen at standard dose.
1091608|NCT00585013|O1|Outcome|1 Treatment|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.~Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
1091609|NCT00585013|O2|Outcome|2 Placebo|Placebo delivery of oxygen at standard dose.
1091610|NCT00585013|O1|Outcome|1 Treatment|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.~Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
1091612|NCT00585013|O1|Outcome|Nitric Oxide Delivery Group|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.~Nitric Oxide: Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
1091613|NCT00585013|E2|Reported Event|2 Placebo|Placebo delivery of oxygen at standard dose.
1091614|NCT00585013|E1|Reported Event|1 Treatment|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.~Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
1091615|NCT00584987|B5|Baseline|Total|Total of all reporting groups
1091616|NCT00584987|B4|Baseline|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091617|NCT00584987|B3|Baseline|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091618|NCT00584987|B2|Baseline|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091619|NCT00584987|B1|Baseline|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091620|NCT00584987|P4|Participant Flow|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091621|NCT00584987|P3|Participant Flow|PL FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091622|NCT00584987|P2|Participant Flow|FF + PL OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091623|NCT00584987|P1|Participant Flow|PL FF + PL OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091624|NCT00584987|O4|Outcome|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091625|NCT00584987|O3|Outcome|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091626|NCT00584987|O2|Outcome|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091627|NCT00584987|O1|Outcome|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091628|NCT00584987|O4|Outcome|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091629|NCT00584987|O3|Outcome|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091630|NCT00584987|O2|Outcome|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091631|NCT00584987|O1|Outcome|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091632|NCT00584987|O4|Outcome|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091633|NCT00584987|O3|Outcome|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091634|NCT00584987|O2|Outcome|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091635|NCT00584987|O1|Outcome|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091636|NCT00584987|O4|Outcome|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091637|NCT00584987|O3|Outcome|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091638|NCT00584987|O2|Outcome|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091639|NCT00584987|O1|Outcome|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091640|NCT00584987|O4|Outcome|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091641|NCT00584987|O3|Outcome|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091642|NCT00584987|O2|Outcome|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091643|NCT00584987|O1|Outcome|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091644|NCT00584987|O4|Outcome|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091645|NCT00584987|O3|Outcome|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091646|NCT00584987|O2|Outcome|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091647|NCT00584987|O1|Outcome|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091648|NCT00584987|E4|Reported Event|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091649|NCT00584987|E3|Reported Event|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091650|NCT00584987|E2|Reported Event|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091651|NCT00584987|E1|Reported Event|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
1091652|NCT00584948|B3|Baseline|Total|Total of all reporting groups
1091653|NCT00584948|B2|Baseline|Placebo|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study
1091655|NCT00584948|P2|Participant Flow|Placebo|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study
1091656|NCT00584948|P1|Participant Flow|Memantine|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.
1091657|NCT00584948|O2|Outcome|Placebo|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study
1091658|NCT00584948|O1|Outcome|Memantine|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.
1091659|NCT00584948|O2|Outcome|Placebo|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study
1091660|NCT00584948|O1|Outcome|Memantine|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.
1091661|NCT00584948|E2|Reported Event|Placebo|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study
1091662|NCT00584948|E1|Reported Event|Memantine|Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.
1091663|NCT00584935|B1|Baseline|Rituximab|
1091664|NCT00584935|P1|Participant Flow|Rituximab|
1091665|NCT00584935|O1|Outcome|Rituximab|
1091666|NCT00584935|E1|Reported Event|Rituximab|
1091667|NCT00584909|B1|Baseline|Paclitaxel + Carboplatin|Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.
1091713|NCT00584831|E4|Reported Event|Balafilcon A|balafilcon A toric contact lens
1091714|NCT00584831|E3|Reported Event|Omafilcon A|omafilcon A toric contact lens
1091668|NCT00584909|P1|Participant Flow|Paclitaxel + Carboplatin|Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.
1091669|NCT00584909|O1|Outcome|Paclitaxel + Carboplatin|Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.
1091670|NCT00584909|O1|Outcome|Paclitaxel + Carboplatin|Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.
1091671|NCT00584909|E1|Reported Event|Paclitaxel + Carboplatin|Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.
1091672|NCT00584857|B1|Baseline|Paclitaxel/Carboplatin/Megesterol Acetate|Paclitaxel will be administered at 175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at a dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at a dosage of 40 mg.
1091673|NCT00584857|P1|Participant Flow|Paclitaxel/Carboplatin/Megesterol Acetate|Paclitaxel will be administered at 175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at a dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at a dosage of 40 mg.
1091674|NCT00584857|O1|Outcome|Paclitaxel/Carboplatin/Megesterol Acetate|Paclitaxel will be administered at 175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at a dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at a dosage of 40 mg.
1091675|NCT00584857|O1|Outcome|Paclitaxel/Carboplatin/Megesterol Acetate|Paclitaxel will be administered at 175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at a dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at a dosage of 40 mg.
1091676|NCT00584857|E1|Reported Event|Paclitaxel/Carboplatin/Megesterol Acetate|Paclitaxel will be administered at 175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at a dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at a dosage of 40 mg.
1091677|NCT00584831|B1|Baseline|Total Study Population|
1091678|NCT00584831|P19|Participant Flow|Group 17 BSOL|balafilcon A toric, senofilcon A toric,omafilcon A toric, lotrafilcon b toric
1091679|NCT00584831|P18|Participant Flow|Group 6 SLOB|senofilcon A toric, lotrafilcon b toric, omafilcon A toric, balafilcon A toric
1091680|NCT00584831|P17|Participant Flow|Group 3 LOSB|lotrafilcon B toric, omafilcon A toric, senofilcon A toric, balafilcon A toric
1091681|NCT00584831|P16|Participant Flow|Group 19 BOSL|balafilcon A toric, omafilcon A toric, senofilcon A toric, lotrafilcon B toric
1091682|NCT00584831|P15|Participant Flow|Group 18 BOLS|balafilcon A toric, omafilcon A toric, lotrafilcon B toric, senofilcon A toric
1091683|NCT00584831|P14|Participant Flow|Group 16 BLOS|balafilcon A toric, lotrafilcon B toric, omafilcon A toric, senofilcon A toric
1094450|NCT00577135|O2|Outcome|Continuous Infusion|
1091684|NCT00584831|P13|Participant Flow|Group 15 BLSO|balafilcon A toric, lotrafilcon B toric, senofilcon A toric, omafilcon A toric
1091685|NCT00584831|P12|Participant Flow|Group 14 OBSL|omafilcon A toric, balafilcon A toric, senofilcon A toric, lotrafilcon B toric
1091686|NCT00584831|P11|Participant Flow|Group 13 OBLS|omafilcon A toric, balafilcon A toric, lotrafilcon B toric, senofilcon A toric
1091687|NCT00584831|P10|Participant Flow|Group 12 OSBL|omafilcon A toric, senofilcon A toric, balafilcon A toric, lotrafilcon B toric
1091688|NCT00584831|P9|Participant Flow|Group 11 OSLB|omafilcon A toric, senofilcon A toric, lotrafilcon B toric, balafilcon A toric
1091689|NCT00584831|P8|Participant Flow|Group 10 SBOL|senofilcon A toric, balafilcon A toric, omafilcon A toric, lotrafilcon B toric
1091690|NCT00584831|P7|Participant Flow|Group 9 SBLO|senofilcon A toric, balafilcon A toric, lotrafilcon B toric, omafilcon A toric
1091691|NCT00584831|P6|Participant Flow|Group 8 SOLB|senofilcon A toric, omafilcon A toric, lotrafilcon B toric, balafilcon A toric
1091692|NCT00584831|P5|Participant Flow|Group 7 SLBO|senofilcon A toric, lotrafilcon B toric, balafilcon A toric, omafilcon A toric
1091693|NCT00584831|P4|Participant Flow|Group 5 LBOS|lotrafilcon B toric, balafilcon A toric, omafilcon A toric, senofilcon A
1091694|NCT00584831|P3|Participant Flow|Group 4 LBSO|lotrafilcon B toric, balafilcon A toric, senofilcon A toric, omafilcon A toric
1091695|NCT00584831|P2|Participant Flow|Group 2 LSBO|lotrafilcon B toric, senofilcon A toric, balafilcon A toric, omafilcon A toric
1091696|NCT00584831|P1|Participant Flow|Group1 LSOB|lotrafilcon b toric, senofilcon A toric, omafilcon A toric, balafilcon A toric
1091697|NCT00584831|O4|Outcome|Balafilcon A|balafilcon A toric
1091698|NCT00584831|O3|Outcome|Omafilcon A|omafilcon A toric
1091699|NCT00584831|O2|Outcome|Senofilcon A|senofilcon A toric
1091700|NCT00584831|O1|Outcome|Lotrafilcon B|lotrafilcon b toric
1091701|NCT00584831|O4|Outcome|Balafilcon A|balafilcon A toric
1091702|NCT00584831|O3|Outcome|Omafilcon A|omafilcon A toric
1091703|NCT00584831|O2|Outcome|Senofilcon A|senofilcon A toric
1091704|NCT00584831|O1|Outcome|Lotrafilcon B|lotrafilcon b toric
1091705|NCT00584831|O4|Outcome|Balafilcon A|balafilcon A toric
1091706|NCT00584831|O3|Outcome|Omafilcon A|omafilcon A toric
1091707|NCT00584831|O2|Outcome|Senofilcon A|senofilcon A toric
1091708|NCT00584831|O1|Outcome|Lotrafilcon B|lotrafilcon b toric
1091709|NCT00584831|O4|Outcome|Balafilcon A|balafilcon A toric
1091715|NCT00584831|E2|Reported Event|Senofilcon A|senofilcon A toric contact lens
1091716|NCT00584831|E1|Reported Event|Lotrafilcon B|lotrafilcon b toric contact lens
1091717|NCT00584740|B3|Baseline|Total|Total of all reporting groups
1091718|NCT00584740|B2|Baseline|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
1091719|NCT00584740|B1|Baseline|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
1091720|NCT00584740|P2|Participant Flow|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
1091721|NCT00584740|P1|Participant Flow|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
1091722|NCT00584740|O2|Outcome|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
1091723|NCT00584740|O1|Outcome|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
1091724|NCT00584740|O2|Outcome|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
1091725|NCT00584740|O1|Outcome|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
1091726|NCT00584740|O2|Outcome|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
1091727|NCT00584740|O1|Outcome|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
1091728|NCT00584740|O2|Outcome|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
1091729|NCT00584740|O1|Outcome|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
1091730|NCT00584740|O2|Outcome|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
1091731|NCT00584740|O1|Outcome|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
1091732|NCT00584740|O2|Outcome|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
1091733|NCT00584740|O1|Outcome|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
1091734|NCT00584740|O2|Outcome|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
1091735|NCT00584740|O1|Outcome|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
1091736|NCT00584740|E2|Reported Event|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
1091737|NCT00584740|E1|Reported Event|AIN457 Twice 10mg/kg|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
1091738|NCT00584727|B1|Baseline|Completed Population|Only participants that completed the study are included (n=88)
1091739|NCT00584727|P6|Participant Flow|Etafilcon A/Alphafilcon A/Senofilcon A|First intervention: etafilcon A sphere contact lenses Second intervention: alphafilcon A toric contact lenses Third intervention: senofilcon A toric contact lenses
1091740|NCT00584727|P5|Participant Flow|Alphafilcon A/Senofilcon A/Etafilcon A|First intervention: alphafilcon A toric Second intervention: senofilcon A toric Third intervention: etafilcon A sphere
1091741|NCT00584727|P4|Participant Flow|Senofilcon A/Etafilcon A/Alphafilcon A|First Intervention: senofilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: alphafilcon A toric contact lenses
1091742|NCT00584727|P3|Participant Flow|Etafilcon A/Senofilcon A/Alphafilcon A|First Intervention: etafilcon A sphere contact lenses Second Intervention: senofilcon A toric contact lenses Third Intervention: alphafilcon A toric contact lenses
1091743|NCT00584727|P2|Participant Flow|Alphafilcon A/Etafilcon A/Senofilcon A|First Intervention: alphafilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: senofilcon A toric contact lenses
1091744|NCT00584727|P1|Participant Flow|Senofilcon A/Alphafilcon A/Etafilcon A|First Intervention: senofilcon A toric contact lenses Second Intervention: alphafilcon A toric contact lenses Third Intervention: etafilcon A sphere contact lenses
1091745|NCT00584727|O3|Outcome|Etafilcon A Sphere|
1091746|NCT00584727|O2|Outcome|Alphafilcon A Toric|
1091747|NCT00584727|O1|Outcome|Senofilcon A Toric|
1091748|NCT00584727|O3|Outcome|Etafilcon A Sphere|
1091749|NCT00584727|O2|Outcome|Alphafilcon A Toric|
1091750|NCT00584727|O1|Outcome|Senofilcon A Toric|
1091751|NCT00584727|O2|Outcome|Alphafilcon A Toric|
1091752|NCT00584727|O1|Outcome|Senofilcon A Toric|
1091753|NCT00584727|O2|Outcome|Alphafilcon A Toric|
1091754|NCT00584727|O1|Outcome|Senofilcon A Toric|
1091755|NCT00584727|O3|Outcome|Etafilcon A Sphere|
1091756|NCT00584727|O2|Outcome|Alphafilcon A Toric|
1091757|NCT00584727|O1|Outcome|Senofilcon A Toric|
1091758|NCT00584727|O3|Outcome|Etafilcon A Sphere|
1091759|NCT00584727|O2|Outcome|Alphafilcon A Toric|
1091760|NCT00584727|O1|Outcome|Senofilcon A Toric|
1091761|NCT00584727|E6|Reported Event|Etafilcon A/Alphafilcon A/Senofilcon A|First intervention: etafilcon A sphere contact lenses Second intervention: alphafilcon A toric contact lenses Third intervention: senofilcon A toric contact lenses
1091762|NCT00584727|E5|Reported Event|Alphafilcon A/Senofilcon A/Etafilcon A|First intervention: alphafilcon A toric Second intervention: senofilcon A toric Third intervention: etafilcon A sphere
1091763|NCT00584727|E4|Reported Event|Senofilcon A/Etafilcon A/Alphafilcon A|First Intervention: senofilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: alphafilcon A toric contact lenses
1091764|NCT00584727|E3|Reported Event|Etafilcon A/Senofilcon A/Alphafilcon A|First Intervention: etafilcon A sphere contact lenses Second Intervention: senofilcon A toric contact lenses Third Intervention: alphafilcon A toric contact lenses
1091765|NCT00584727|E2|Reported Event|Alphafilcon A/Etafilcon A/Senofilcon A|First Intervention: alphafilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: senofilcon A toric contact lenses
1091766|NCT00584727|E1|Reported Event|Senofilcon A/Alphafilcon A/Etafilcon A|First Intervention: senofilcon A toric contact lenses Second Intervention: alphafilcon A toric contact lenses Third Intervention: etafilcon A sphere contact lenses
1091767|NCT00584701|B1|Baseline|Active Risperidone|Risperidone was started at 0.5mg at bedtime for 4 days. If that dosage was tolerated and there were continued behavioral symptoms, the dose was increased to 1mg at bedtime for an additional 4 days. If tolerated and indicated, 0.5mg was added in the morning for a daily total of 1.5 mg.
1091768|NCT00584701|P1|Participant Flow|Active Risperidone|Risperidone was started at 0.5mg at bedtime for 4 days. If that dosage was tolerated and there were continued behavioral symptoms, the dose was increased to 1mg at bedtime for an additional 4 days. If tolerated and indicated, 0.5mg was added in the morning for a daily total of 1.5 mg.
1091769|NCT00584701|O1|Outcome|Risperidone|Risperidone was started at 0.5mg at bedtime for 4 days. If that dosage was tolerated and there were continued behavioral symptoms, the dose was increased to 1mg at bedtime for an additional 4 days. If tolerated and indicated, 0.5mg was added in the morning for a daily total of 1.5 mg.
1091770|NCT00584701|O1|Outcome|Active Risperidone|Risperidone was started at 0.5mg at bedtime for 4 days. If that dosage was tolerated and there were continued behavioral symptoms, the dose was increased to 1mg at bedtime for an additional 4 days. If tolerated and indicated, 0.5mg was added in the morning for a daily total of 1.5 mg.
1091771|NCT00584701|E1|Reported Event|Active Risperidone|Risperidone was started at 0.5mg at bedtime for 4 days. If that dosage was tolerated and there were continued behavioral symptoms, the dose was increased to 1mg at bedtime for an additional 4 days. If tolerated and indicated, 0.5mg was added in the morning for a daily total of 1.5 mg.
1091772|NCT00584480|B1|Baseline|Hyperbaric Oxygen Treatment (HBOT)|Subjects received a total of 80 days (therefore, 80 treatments) over 20 weeks: 40 days of Hyperbaric Oxygen Treatment (HBOT) (1.5 atmosphere absolute; 100 percent oxygen) for 1 hour, 5 days a week for 8 weeks, followed by a 4 week break, and then another 40 days of HBOT over 8 weeks.
1091773|NCT00584480|P1|Participant Flow|Hyperbaric Oxygen Treatment (HBOT)|Subjects received a total of 80 days (therefore, 80 treatments) over 20 weeks: 40 days of Hyperbaric Oxygen Treatment (HBOT) (1.5 atmosphere absolute; 100 percent oxygen) for 1 hour, 5 days a week for 8 weeks, followed by a 4 week break, and then another 40 days of HBOT over 8 weeks.
1091774|NCT00584480|O1|Outcome|Hyperbaric Oxygen Treatment (HBOT)|Subjects received a total of 80 days (therefore, 80 treatments) over 20 weeks: 40 days of Hyperbaric Oxygen Treatment (HBOT) (1.5 atmosphere absolute; 100 percent oxygen) for 1 hour, 5 days a week for 8 weeks, followed by a 4 week break, and then another 40 days of HBOT over 8 weeks.
1091775|NCT00584480|E1|Reported Event|Hyperbaric Oxygen Treatment (HBOT)|Subjects received a total of 80 days (therefore, 80 treatments) over 20 weeks: 40 days of Hyperbaric Oxygen Treatment (HBOT) (1.5 atmosphere absolute; 100 percent oxygen) for 1 hour, 5 days a week for 8 weeks, followed by a 4 week break, and then another 40 days of HBOT over 8 weeks.
1091776|NCT00584454|B1|Baseline|Q Fever Vaccine (NDBR 105)|"Volunteers will receive and intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase 1, MNLBR 110) in the volar aspect of the arm. Skin test will be evaluated; if erythema occurs after the skin test, it is medically contraindicated to vaccinate that volunteer. Volunteers with skin test reactions will not be vaccinated and withdrawn from the study.~Q-Fever Vaccine, NDBR 105: Each volunteer will receive an intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase I, MNLBR 110) in the volar aspect of the arm on Day -7 of the study.Volunteers with skin test reactions that are considered negative may be vaccinated with Q Fever Vaccine, Phase I, Inactivated, Freeze-Dried, NDBR 105 (subcutaneously, 0.5 ml) in the upper outer aspect of the arm on Day 0 of the study."
1091802|NCT00583947|P1|Participant Flow|ARF/LEV|"Cross-over period: one day active treatment with arformoterol 7.5 microgram per nebulization followed by a 7 day washout. Then a one day active treatment with levalbuterol 0.63 milligram per nebulization.~Open-label period: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization."
1091777|NCT00584454|P1|Participant Flow|Q Fever Vaccine (NDBR 105)|"Volunteers will receive and intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase 1, MNLBR 110) in the volar aspect of the arm. Skin test will be evaluated; if erythema occurs after the skin test, it is medically contraindicated to vaccinate that volunteer. Volunteers with skin test reactions will not be vaccinated and withdrawn from the study.~Q-Fever Vaccine, NDBR 105: Each volunteer will receive an intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase I, MNLBR 110) in the volar aspect of the arm on Day -7 of the study.Volunteers with skin test reactions that are considered negative may be vaccinated with Q Fever Vaccine, Phase I, Inactivated, Freeze-Dried, NDBR 105 (subcutaneously, 0.5 ml) in the upper outer aspect of the arm on Day 0 of the study."
1091778|NCT00584454|O1|Outcome|Q Fever Vaccine (NDBR 105)|"Volunteers will receive and intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase 1, MNLBR 110) in the volar aspect of the arm. Skin test will be evaluated; if erythema occurs after the skin test, it is medically contraindicated to vaccinate that volunteer. Volunteers with skin test reactions will not be vaccinated and withdrawn from the study.~Q-Fever Vaccine, NDBR 105: Each volunteer will receive an intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase I, MNLBR 110) in the volar aspect of the arm on Day -7 of the study.Volunteers with skin test reactions that are considered negative may be vaccinated with Q Fever Vaccine, Phase I, Inactivated, Freeze-Dried, NDBR 105 (subcutaneously, 0.5 ml) in the upper outer aspect of the arm on Day 0 of the study."
1091779|NCT00584454|E1|Reported Event|Q Fever Vaccine (NDBR 105)|"Volunteers will receive and intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase 1, MNLBR 110) in the volar aspect of the arm. Skin test will be evaluated; if erythema occurs after the skin test, it is medically contraindicated to vaccinate that volunteer. Volunteers with skin test reactions will not be vaccinated and withdrawn from the study.~Q-Fever Vaccine, NDBR 105: Each volunteer will receive an intradermal dose of 0.1 ml of the skin test antigen (Q fever Skin Test Antigen, Henzerling Strain, Phase I, MNLBR 110) in the volar aspect of the arm on Day -7 of the study.Volunteers with skin test reactions that are considered negative may be vaccinated with Q Fever Vaccine, Phase I, Inactivated, Freeze-Dried, NDBR 105 (subcutaneously, 0.5 ml) in the upper outer aspect of the arm on Day 0 of the study."
1091780|NCT00584415|B1|Baseline|PV Isolation + GP Ablation|All patients received pulmonary vein antrum isolation (PV isolation) and ablation of the major atrial ganglionated plexi (superior left GP, inferior left GP, anterior right GP and inferior right GP). Ganglionated plexi (GP) were identified by delivering high-frequency stimulation (20 Hz) from the ablation catheter. If vagal response (AV block) was initiated by stimulation, that site was counted as a GP site and was then ablated.
1091781|NCT00584415|P1|Participant Flow|GP Ablation + PV Isolation|All patients in this study received pulmonary vein isolation (PVI) and ganglionated plexi (GP) ablation to treat paroxysmal AF
1092809|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
1091782|NCT00584415|O1|Outcome|Experimental Arm (GP Ablation + PV Antrum Isolation)|All patients received high-frequency stimulation (20 Hz) to the presumed GP site to elicit a vagal response (AV block). After all GP sites were ablated, all patients underwent circumferential PV isolation.
1091783|NCT00584415|O1|Outcome|GP Ablation + PV Isolation)|All patients received high-frequency stimulation (20 Hz) to the presumed GP site to elicit a vagal response (AV block). After all GP sites were ablated, all patients underwent circumferential PV isolation.
1091784|NCT00584415|E1|Reported Event|Experimental Arm (GP Ablation + PV Antrum Isolation)|All patients received high-frequency stimulation (20 Hz) to the presumed GP site to elicit a vagal response (AV block). After all GP sites were ablated, all patients underwent circumferential PV isolation.
1091785|NCT00584220|B1|Baseline|All Subjects|Subjects who enrolled and completed the study.
1091786|NCT00584220|P2|Participant Flow|Alphafilcon A / Senofilcon A|alphafilcon A toric hydrogel contact lenses worn first, then senofilcon A toric silicone hydrogel contact lenses worn second
1091787|NCT00584220|P1|Participant Flow|Senofilcon A / Alphafilcon A|senofilcon A toric silicone hydrogel contact lenses worn first, then alphafilcon A toric hydrogel contact lenses worn second
1091788|NCT00584220|O2|Outcome|Alphafilcon A Toric|contact lenses
1091789|NCT00584220|O1|Outcome|Senofilcon A Toric|contact lenses
1091790|NCT00584220|O2|Outcome|Alphafilcon A Toric|contact lenses
1091791|NCT00584220|O1|Outcome|Senofilcon A Toric|contact lenses
1091792|NCT00584220|E2|Reported Event|Alphafilcon A|alphafilcon A toric hydrogel contact lenses worn
1091793|NCT00584220|E1|Reported Event|Senofilcon A|senofilcon A toric silicone hydrogel contact lenses worn
1091794|NCT00584077|B1|Baseline|Lung Transplant Recipients With Stable Lung Function|All enrolled subjects underwent bronchoscopy to determine presence of cough as well as the location of airway eliciting a cough response
1091795|NCT00584077|P1|Participant Flow|Lung Transplant Recipients With Stable Lung Function|All enrolled subjects underwent bronchoscopy to determine presence of cough as well as the location of airway eliciting a cough response
1091796|NCT00584077|O1|Outcome|Lung Transplant Recipients With Stable Lung Function|All enrolled subjects underwent bronchoscopy to determine presence of cough as well as the location of airway eliciting a cough response
1091797|NCT00584077|E1|Reported Event|Lung Transplant Recipients With Stable Lung Function|Enrolled subjects underwent bronchoscopy to assess for presence of cough reflex in the transpalnted and non-transplanted lung
1091798|NCT00583947|B3|Baseline|Total|Total of all reporting groups
1091799|NCT00583947|B2|Baseline|LEV/ARF|"Cross-over: Participants treated with levalbuterol 0.63 milligram per nebulization; 7 day washout; arformoterol 7.5 microgram per nebulization.~Open label: 7 day washout; arformoterol 15 microgram per nebulization."
1091800|NCT00583947|B1|Baseline|ARF/LEV|"Cross-over: Participants treated with arformoterol 7.5 microgram per nebulization; 7 day washout; levalbuterol 0.63 milligram per nebulization.~Open label: 7 day washout; arformoterol 15 microgram per nebulization."
1091801|NCT00583947|P2|Participant Flow|LEV/ARF|"Cross-over period: one day active treatment with levalbuterol 0.63 milligram per nebulization followed by a 7 day washout. Then a one day active treatment with arformoterol 7.5 micrograms per nebulization.~Open-label period: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization."
1091803|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
1094451|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
1091804|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
1091805|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
1091806|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
1091807|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
1091808|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
1091809|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
1091810|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
1091811|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
1091812|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
1091813|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
1091814|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
1091815|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
1091816|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
1091817|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
1091818|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
1091819|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
1091820|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
1092810|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
1091821|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
1091822|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
1091823|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
1091824|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
1091825|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
1091826|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
1091827|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
1091828|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
1091829|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
1091830|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
1091831|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
1091832|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
1091833|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
1091834|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
1091835|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
1091836|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
1091837|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
1091838|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
1091839|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
1091840|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
1091841|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
1091842|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
1094452|NCT00577135|O4|Outcome|High Intensification|
1091843|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
1091844|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
1091845|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
1091846|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
1091847|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
1091848|NCT00583947|E3|Reported Event|Arformoterol 15 Mcg|The experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study.
1091849|NCT00583947|E2|Reported Event|Arformoterol 7.5 Mcg|The experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study.
1091850|NCT00583947|E1|Reported Event|Levalbuterol 0.63 mg|The experience of participants when treated with levalbuterol during the cross-over portion of the study.
1091851|NCT00583908|B1|Baseline|Overall Study Population|Summary for overall study population
1091852|NCT00583908|P12|Participant Flow|Balafilcon A / Omafilcon A / Lotrafilcon B / Senofilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
1091853|NCT00583908|P11|Participant Flow|Balafilcon A / Senofilcon A / Omafilcon A / Lotrafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
1091854|NCT00583908|P10|Participant Flow|Balafilcon A / Senofilcon A / Lotrafilcon B / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
1091855|NCT00583908|P9|Participant Flow|Balafilcon A / Lotrafilcon B / Omafilcon A / Senofilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
1091856|NCT00583908|P8|Participant Flow|Balafilcon A / Lotrafilcon B / Senofilcon A / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
1091857|NCT00583908|P7|Participant Flow|Omafilcon A / Lotrafilcon B / Senofilcon A / Balafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
1091858|NCT00583908|P6|Participant Flow|Senofilcon A / Balafilcon A / Lotrafilcon B / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
1092053|NCT00583115|B1|Baseline|Gleevec|"Drug taken orally 260mg/M2/day once per day~Gleevec: 260 mg/M2/day, given once daily by mouth"
1091859|NCT00583908|P5|Participant Flow|Senofilcon A / Omafilcon A / Balafilcon A / Lotrafilcon B|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
1091860|NCT00583908|P4|Participant Flow|Senofilcon A / Lotrafilcon B / Omafilcon A / Balafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
1091861|NCT00583908|P3|Participant Flow|Lotrafilcon B / Balafilcon A / Senofilcon A / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
1091862|NCT00583908|P2|Participant Flow|Lotrafilcon B / Omafilcon A / Senofilcon A / Balafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
1091863|NCT00583908|P1|Participant Flow|Lotrafilcon B / Senofilcon A / Balafilcon A / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
1091864|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
1091865|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
1091866|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
1091867|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
1091868|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
1091869|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
1091870|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
1091871|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
1091872|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
1091873|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
1091874|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
1091875|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
1091876|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
1091877|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
1091878|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
1091879|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
1091880|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
1091881|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
1091882|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
1091883|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
1091884|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
1091885|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
1091886|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
1091887|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
1091888|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
1091889|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
1091890|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
1091891|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
1091892|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
1091893|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
1091894|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
1091895|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
1091896|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
1091897|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
1091898|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
1091899|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
1091900|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
1091901|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
1091902|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
1091903|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
1091904|NCT00583908|E12|Reported Event|Balafilcon A / Omafilcon A / Lotrafilcon B / Senofilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
1091905|NCT00583908|E11|Reported Event|Balafilcon A / Senofilcon A / Omafilcon A / Lotrafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
1091906|NCT00583908|E10|Reported Event|Balafilcon A / Senofilcon A / Lotrafilcon B / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
1092820|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr
1091907|NCT00583908|E9|Reported Event|Balafilcon A / Lotrafilcon B / Omafilcon A / Senofilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
1091908|NCT00583908|E8|Reported Event|Balafilcon A / Lotrafilcon B / Senofilcon A / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
1091909|NCT00583908|E7|Reported Event|Omafilcon A / Lotrafilcon B / Senofilcon A / Balafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
1091910|NCT00583908|E6|Reported Event|Senofilcon A / Balafilcon A / Lotrafilcon B / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
1091911|NCT00583908|E5|Reported Event|Senofilcon A / Omafilcon A / Balafilcon A / Lotrafilcon B|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
1091912|NCT00583908|E4|Reported Event|Senofilcon A / Lotrafilcon B / Omafilcon A / Balafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
1091913|NCT00583908|E3|Reported Event|Lotrafilcon B / Balafilcon A / Senofilcon A / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
1091914|NCT00583908|E2|Reported Event|Lotrafilcon B / Omafilcon A / Senofilcon A / Balafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
1091915|NCT00583908|E1|Reported Event|Lotrafilcon B / Senofilcon A / Balafilcon A / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
1091916|NCT00583713|B4|Baseline|Total|Total of all reporting groups
1091917|NCT00583713|B3|Baseline|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
1091918|NCT00583713|B2|Baseline|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
1091919|NCT00583713|B1|Baseline|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
1091920|NCT00583713|P3|Participant Flow|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
1091921|NCT00583713|P2|Participant Flow|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
1091922|NCT00583713|P1|Participant Flow|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
1091923|NCT00583713|O3|Outcome|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
1091924|NCT00583713|O2|Outcome|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
1091925|NCT00583713|O1|Outcome|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
1091926|NCT00583713|O3|Outcome|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
1091927|NCT00583713|O2|Outcome|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
1091928|NCT00583713|O1|Outcome|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
1091929|NCT00583713|O3|Outcome|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
1091930|NCT00583713|O2|Outcome|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
1091931|NCT00583713|O1|Outcome|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
1091932|NCT00583713|O3|Outcome|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
1091933|NCT00583713|O2|Outcome|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
1091934|NCT00583713|O1|Outcome|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
1091935|NCT00583713|O3|Outcome|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
1091938|NCT00583713|O3|Outcome|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
1091939|NCT00583713|O2|Outcome|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
1091940|NCT00583713|O1|Outcome|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
1091941|NCT00583713|E3|Reported Event|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
1091942|NCT00583713|E2|Reported Event|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
1091943|NCT00583713|E1|Reported Event|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
1091944|NCT00583700|B3|Baseline|Total|Total of all reporting groups
1091945|NCT00583700|B2|Baseline|Intervention: Pentoxifylline & Vitamin E|"Combined treatment with Pentoxifylline and Vitamin E.~Vitamin E : Vitamin E (Over-the-counter) 400 I.U. once daily~Pentoxifylline : Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy."
1091946|NCT00583700|B1|Baseline|Control Arm|Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis.
1091947|NCT00583700|P2|Participant Flow|Intervention: Pentoxifylline & Vitamin E|"Combined treatment with Pentoxifylline and Vitamin E.~Vitamin E : Vitamin E (Over-the-counter) 400 I.U. once daily~Pentoxifylline : Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy."
1091948|NCT00583700|P1|Participant Flow|Control Arm|Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis.
1091949|NCT00583700|O2|Outcome|Intervention: Pentoxifylline & Vitamin E|"Combined treatment with Pentoxifylline and Vitamin E.~Vitamin E : Vitamin E (Over-the-counter) 400 I.U. once daily~Pentoxifylline : Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy."
1091950|NCT00583700|O1|Outcome|Control Arm|Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis.
1091951|NCT00583700|O2|Outcome|Intervention: Pentoxifylline & Vitamin E|"Combined treatment with Pentoxifylline and Vitamin E.~Vitamin E : Vitamin E (Over-the-counter) 400 I.U. once daily~Pentoxifylline : Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy."
1091952|NCT00583700|O1|Outcome|Control Arm|Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis.
1092054|NCT00583115|P1|Participant Flow|Gleevec|"Drug taken orally 260mg/M2/day once per day~Gleevec: 260 mg/M2/day, given once daily by mouth"
1091953|NCT00583700|E2|Reported Event|Intervention: Pentoxifylline & Vitamin E|"Combined treatment with Pentoxifylline and Vitamin E.~Vitamin E : Vitamin E (Over-the-counter) 400 I.U. once daily~Pentoxifylline : Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy."
1091954|NCT00583700|E1|Reported Event|Control Arm|Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis.
1091955|NCT00583661|B1|Baseline|EXCOR Pediatric|Implantation of the EXCOR Pediatric Ventricular Assist Device
1091956|NCT00583661|P1|Participant Flow|EXCOR Pediatric|Implantation of the EXCOR Pediatric Ventricular Assist Device
1091957|NCT00583661|O2|Outcome|Cohort 2|Subjects with Body Surface Area 0.7-1.5m^2
1091958|NCT00583661|O1|Outcome|Cohort 1|Subjects with Body Surface Area < 0.7m^2
1091959|NCT00583661|O2|Outcome|Cohort 2|Subjects with Body Surface Area 0.7-1.5m^2
1091960|NCT00583661|O1|Outcome|Cohort 1|Subjects with Body Surface Area < 0.7m^2
1091961|NCT00583661|E1|Reported Event|EXCOR Pediatric|Implantation of the EXCOR Pediatric Ventricular Assist Device
1091962|NCT00583622|B1|Baseline|Bevacizumab + High-Dose Chemotherapy|Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
1091963|NCT00583622|P1|Participant Flow|Bevacizumab + High-Dose Chemotherapy|Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
1091964|NCT00583622|O1|Outcome|Bevacizumab + High-Dose Chemotherapy|Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
1091965|NCT00583622|O1|Outcome|Bevacizumab + High-Dose Chemotherapy|Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
1091966|NCT00583622|E1|Reported Event|Bevacizumab + High-Dose Chemotherapy|Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
1091967|NCT00583596|B1|Baseline|Long Term Follow-up for Subjects Implanted With the Device|Subjects enrolled in IDE study subject to Post Market Surveillance
1091968|NCT00583596|P1|Participant Flow|Long Term Follow-up for Subjects Implanted With the Device|Subjects enrolled in IDE study subject to Post Market Surveillance
1091969|NCT00583596|O1|Outcome|Long Term Follow-up for Subjects Implanted With the Device|Subjects enrolled in IDE study subject to Post Market Surveillance
1091970|NCT00583596|O1|Outcome|Long Term Follow-up for Subjects Implanted With the Device|Subjects implanted with Amplatzer duct occluder that have final follow-up taking place 5 yrs., 6 yrs., or 7 yrs., post implant.
1091971|NCT00583596|E1|Reported Event|Long Term Follow-up for Subjects Implanted With the Device|Subjects enrolled in IDE study subject to Post Market Surveillance
1091972|NCT00583557|B1|Baseline|Belimumab 10 mg/kg|
1091973|NCT00583557|P1|Participant Flow|Belimumab 10 mg/kg|Subjects received belimumab at a dose of 10 mg/kg IV every 28 days for up to 5 years in this protocol
1091974|NCT00583557|O1|Outcome|Belimumab 10 mg/kg|Subjects received belimumab at a dose of 10 mg/kg IV every 28 days for up to 5 years in this protocol
1091975|NCT00583557|E1|Reported Event|Belimumab 10 mg/kg|Subjects received belimumab at a dose of 10 mg/kg IV every 28 days for up to 5 years in this protocol
1091976|NCT00583492|B3|Baseline|Total|Total of all reporting groups
1091977|NCT00583492|B2|Baseline|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy~IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
1091978|NCT00583492|B1|Baseline|Gene Therapy + IMRT|"Gene Therapy + IMRT~Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
1091979|NCT00583492|P2|Participant Flow|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy~IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
1091980|NCT00583492|P1|Participant Flow|Gene Therapy + IMRT|"Gene Therapy + IMRT~Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
1091981|NCT00583492|O2|Outcome|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy~IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
1091982|NCT00583492|O1|Outcome|Gene Therapy + IMRT|"Gene Therapy + IMRT~Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
1091983|NCT00583492|O2|Outcome|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy~IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
1091984|NCT00583492|O1|Outcome|Gene Therapy + IMRT|"Gene Therapy + IMRT~Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
1091985|NCT00583492|O2|Outcome|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy~IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
1092055|NCT00583115|O1|Outcome|Gleevec|"Drug taken orally 260mg/M2/day once per day~Gleevec: 260 mg/M2/day, given once daily by mouth"
1091986|NCT00583492|O1|Outcome|Gene Therapy + IMRT|"Gene Therapy + IMRT~Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
1091987|NCT00583492|O2|Outcome|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy~IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
1091988|NCT00583492|O1|Outcome|Gene Therapy + IMRT|"Gene Therapy + IMRT~Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
1091989|NCT00583492|O2|Outcome|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy~IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
1091990|NCT00583492|O1|Outcome|Gene Therapy + IMRT|"Gene Therapy + IMRT~Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
1091991|NCT00583492|O2|Outcome|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy~IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
1091992|NCT00583492|O1|Outcome|Gene Therapy + IMRT|"Gene Therapy + IMRT~Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
1091993|NCT00583492|E2|Reported Event|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy~IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
1091994|NCT00583492|E1|Reported Event|Gene Therapy + IMRT|"Gene Therapy + IMRT~Ad5-yCD/mutTKSR39rep-ADP: 1 x 10^12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
1091995|NCT00583453|B3|Baseline|Total|Total of all reporting groups
1091996|NCT00583453|B2|Baseline|Placebo With Same Dosing Schedule as the Active Comparator Arm|"Placebo with same dosing schedule as the active comparator arm~Placebo: Placebo capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
1091997|NCT00583453|B1|Baseline|Celecoxib 200 mg Tablets|"Celecoxib 200 mg tablets~Celecoxib: Celecoxib 200 mg capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
1091998|NCT00583453|P2|Participant Flow|Placebo Control, Active Comparator|"Placebo with same dosing schedule as the active comparator arm~Placebo: Placebo capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
1091999|NCT00583453|P1|Participant Flow|Celecoxib as Experimerimental Intervention|"Celecoxib 200 mg tablets~Celecoxib: Celecoxib 200 mg capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
1092000|NCT00583453|O2|Outcome|Placebo Control, Active Comparator|"Placebo with same dosing schedule as the active comparator arm~Placebo: Placebo capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
1092001|NCT00583453|O1|Outcome|Celecoxib as Experimerimental Intervention|"Celecoxib 200 mg tablets~Celecoxib: Celecoxib 200 mg capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
1092149|NCT00582712|O1|Outcome|Lithium Capsules|Lithium carbonate: Lithium 300mg by mouth, three times daily, escalated to a lithium level of 0.8-1.2; Continued until progressive disease/unacceptable toxicity; Evaluated every 4 weeks.
1092002|NCT00583453|O2|Outcome|Placebo With Same Dosing Schedule as the Active Comparator Arm|"Placebo with same dosing schedule as the active comparator arm~Placebo: Placebo capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
1092003|NCT00583453|O1|Outcome|Celecoxib 200 mg Tablets|"Celecoxib 200 mg tablets~Celecoxib: Celecoxib 200 mg capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
1092004|NCT00583453|O2|Outcome|Placebo Control, Active Comparator|"Placebo with same dosing schedule as the active comparator arm~Placebo: Placebo capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
1092005|NCT00583453|O1|Outcome|Celecoxib as Experimerimental Intervention|"Celecoxib 200 mg tablets~Celecoxib: Celecoxib 200 mg capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
1092006|NCT00583453|O2|Outcome|Placebo Control, Active Comparator|"Placebo with same dosing schedule as the active comparator arm~Placebo: Placebo capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
1092007|NCT00583453|O1|Outcome|Celecoxib as Experimerimental Intervention|"Celecoxib 200 mg tablets~Celecoxib: Celecoxib 200 mg capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
1092008|NCT00583453|O2|Outcome|Placebo With Same Dosing Schedule as the Active Comparator Arm|"Placebo with same dosing schedule as the active comparator arm~Placebo: Placebo capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
1092009|NCT00583453|O1|Outcome|Celecoxib 200 mg Tablets|"Celecoxib 200 mg tablets~Celecoxib: Celecoxib 200 mg capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
1092056|NCT00583115|O1|Outcome|Gleevec|"Drug taken orally 260mg/M2/day once per day~Gleevec: 260 mg/M2/day, given once daily by mouth"
1092821|NCT00580788|O4|Outcome|Group 4|PTHrP (1-36) 6 picomoles/kg/hr
1092010|NCT00583453|E2|Reported Event|Placebo Control, Active Comparator|"Placebo with same dosing schedule as the active comparator arm~Placebo: Placebo capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
1092011|NCT00583453|E1|Reported Event|Celecoxib as Experimerimental Intervention|"Celecoxib 200 mg tablets~Celecoxib: Celecoxib 200 mg capsule~capsule the night before surgery~capsules the morning of surgery~1 capsule the night of surgery~1 capsule twice daily for 10 days immediately after the surgery"
1092012|NCT00583362|B1|Baseline|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
1092013|NCT00583362|P1|Participant Flow|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
1092014|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
1092015|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
1092016|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
1092017|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
1092018|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
1092019|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
1092020|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
1092021|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
1092022|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
1092023|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
1092057|NCT00583115|E1|Reported Event|Gleevec|"Drug taken orally 260mg/M2/day once per day~Gleevec: 260 mg/M2/day, given once daily by mouth"
1092058|NCT00582972|B1|Baseline|Experimental|Subjects will receive omeprazole 40 mg daily for 30 days
1092024|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
1092025|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
1092026|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
1092027|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
1092028|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
1092029|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
1092030|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
1092031|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
1092032|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
1092073|NCT00582907|P3|Participant Flow|Placebo-Rilonacept-Placebo-Rilonacept|Patients received in the randomized sequence above two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
1092033|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
1092034|NCT00583362|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
1092035|NCT00583362|E1|Reported Event|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab every 28 days as an intravenous (IV) infusion over a period of 1 to 2 hours. The first dose of belimumab was given 4 weeks after the last (Day 532) dose in LBSL02. Treatment continued for 10 years from the time the last participant was enrolled in the present study or until there were 100 or fewer participants continuing in the study, whichever came first. All participants received standard of care for systemic lupus erythematosus (SLE) during study participation.
1092059|NCT00582972|P1|Participant Flow|Experimental|Subjects will receive omeprazole 40 mg daily for 30 days
1092060|NCT00582972|O1|Outcome|Experimental|Subjects received omeprazole 40 mg daily for 30 days
1092061|NCT00582972|O1|Outcome|Experimental|omeprazole 40 mg daily for 30 days
1092062|NCT00582972|E1|Reported Event|Experimental|Subjects will receive omeprazole 40 mg daily for 30 days
1092822|NCT00580788|O3|Outcome|Group 3|PTHrP (1-36) 5 pmol/kg/hr
1092036|NCT00583219|B1|Baseline|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
1092037|NCT00583219|P1|Participant Flow|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
1092038|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
1092039|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
1092040|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
1092041|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
1092042|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
1092043|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
1092052|NCT00583219|E1|Reported Event|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
1092044|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
1092045|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
1092046|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
1092047|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
1092048|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
1092049|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
1092050|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
1092074|NCT00582907|P2|Participant Flow|Rilonacept-Placebo-Placebo-Rilonacept|Patients received in the randomized sequence above two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine. Overall study was 12 months.
1092150|NCT00582712|E1|Reported Event|Lithium Capsules|Lithium carbonate: Lithium 300mg by mouth, three times daily, escalated to a lithium level of 0.8-1.2; Continued until progressive disease/unacceptable toxicity; Evaluated every 4 weeks.
1092051|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
1092063|NCT00582946|B1|Baseline|Magnetic Contact Hearing Aid|Subjects were treated with a hearing aid which provided amplification intended to treat mild to moderate sensorineural hearing loss. Acute performance and safety assessed at 4 months compared to unaided baseline pre-treatment, followed by longer-term assessment of safety up to 10 months.
1092064|NCT00582946|P1|Participant Flow|Magnetic Contact Hearing Aid|Subjects were treated with a hearing aid which provided amplification intended to treat mild to moderate sensorineural hearing loss. Acute performance and safety assessed at 4 months compared to unaided baseline pre-treatment, followed by longer-term assessment of safety up to 10 months.
1092065|NCT00582946|O1|Outcome|Maximum Equivalent Pressure Output|Provision of amplification to treat sensorineural hearing loss with direct-drive hearing aid for acute evaluation of efficacy.
1092066|NCT00582946|E1|Reported Event|Magnetic Contact Hearing Aid|Subjects were treated with a hearing aid which provided amplification intended to treat mild to moderate sensorineural hearing loss. Acute performance and safety assessed at 4 months compared to unaided baseline pre-treatment, followed by longer-term assessment of safety up to 10 months.
1092067|NCT00582933|B1|Baseline|Transplant Patients|BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF: All research participants will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8- 1.0 mg/Kg/dose Q6H x 10 doses), melphalan (70 mg/m2/dose x 2 doses) and fludarabine (25 mg/m2/day x 5 doses). Doses of busulfan will be adjusted according to plasma levels. All research participants will also receive ATG (thymoglobulin®) prior to transplant to promote engraftment.All research participants will also receive G-CSF posttransplant to foster engraftment.
1092068|NCT00582933|P1|Participant Flow|Transplant Patients|BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF: All research participants will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8- 1.0 mg/Kg/dose Q6H x 10 doses), melphalan (70 mg/m2/dose x 2 doses) and fludarabine (25 mg/m2/day x 5 doses). Doses of busulfan will be adjusted according to plasma levels. All research participants will also receive ATG (thymoglobulin®) prior to transplant to promote engraftment.All research participants will also receive G-CSF posttransplant to foster engraftment.
1092069|NCT00582933|O1|Outcome|Transplant Patients|BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF: All research participants will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8- 1.0 mg/Kg/dose Q6H x 10 doses), melphalan (70 mg/m2/dose x 2 doses) and fludarabine (25 mg/m2/day x 5 doses). Doses of busulfan will be adjusted according to plasma levels. All research participants will also receive ATG (thymoglobulin®) prior to transplant to promote engraftment.All research participants will also receive G-CSF posttransplant to foster engraftment.
1092070|NCT00582933|E1|Reported Event|Transplant Patients|BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF: All research participants will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8- 1.0 mg/Kg/dose Q6H x 10 doses), melphalan (70 mg/m2/dose x 2 doses) and fludarabine (25 mg/m2/day x 5 doses). Doses of busulfan will be adjusted according to plasma levels. All research participants will also receive ATG (thymoglobulin®) prior to transplant to promote engraftment.All research participants will also receive G-CSF posttransplant to foster engraftment.
1092071|NCT00582907|B1|Baseline|All Patients Received Both Rilonacept and Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
1092072|NCT00582907|P4|Participant Flow|Placebo-Rilonacept-Rilonacept-Placebo|Patients received in the randomized sequence above two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
1092151|NCT00582660|B3|Baseline|Total|Total of all reporting groups
1092075|NCT00582907|P1|Participant Flow|Rilonacept-Placebo-Rilonacept-Placebo|Patients received in the randomized sequence above two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine. Overall study was 12 months.
1092076|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
1092077|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
1092078|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
1092079|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
1092126|NCT00582738|O1|Outcome|CsA-TAC|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
1092080|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
1092081|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
1092082|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
1092083|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
1092084|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
1092085|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
1092086|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
1092087|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
1092148|NCT00582712|P1|Participant Flow|Lithium Capsules|Lithium carbonate: Lithium 300mg by mouth, three times daily, escalated to a lithium level of 0.8-1.2; Continued until progressive disease/unacceptable toxicity; Evaluated every 4 weeks.
1092088|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
1092089|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
1092090|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
1092091|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
1092127|NCT00582738|O2|Outcome|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
1092128|NCT00582738|O1|Outcome|Standard Treatment|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
1092092|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
1092093|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
1092094|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
1092095|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
1092096|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
1092097|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
1092098|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
1092099|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
1092100|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
1092152|NCT00582660|B2|Baseline|Placebo|1 tablet BID given for 7 days before surgery
1092101|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
1092102|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
1092103|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
1092104|NCT00582907|E2|Reported Event|Rilonacept|"Adverse events during rilonacept treatment. Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo."
1092105|NCT00582907|E1|Reported Event|Placebo|"Adverse events during placebo treatment. Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo."
1092106|NCT00582894|B1|Baseline|Reduced Intensity Regimen|Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
1092107|NCT00582894|P1|Participant Flow|Reduced Intensity Regimen|Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
1092108|NCT00582894|O1|Outcome|Reduced Intensity Regimen|Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
1092109|NCT00582894|O1|Outcome|Reduced Intensity Regimen|Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
1092110|NCT00582894|O1|Outcome|Reduced Intensity Regimen|Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
1092111|NCT00582894|O1|Outcome|Reduced Intensity Regimen|Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
1092112|NCT00582894|E1|Reported Event|Reduced Intensity Regimen|Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
1092113|NCT00582790|B1|Baseline|Zoledronic Acid and Interleukin-2|"Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle.~patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.~The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa."
1092114|NCT00582790|P1|Participant Flow|Zoledronic Acid and Interleukin-2|"Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle.~patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.~The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa."
1092115|NCT00582790|O1|Outcome|Low-dose IL2 and Zoledronic Acid|"Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle.~patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.~The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa."
1092116|NCT00582790|O1|Outcome|IL2 and Zoledronic Acid|"Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle.~patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.~The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa."
1092117|NCT00582790|O1|Outcome|IL2 and Zoledronic Acid|"Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle.~patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.~The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa."
1092118|NCT00582790|O1|Outcome|IL2 and Zoledronic Acid|"Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle.~patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.~The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa."
1092119|NCT00582790|E1|Reported Event|Zoledronic Acid and Interleukin-2|"Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle.~patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.~The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa."
1092120|NCT00582738|B3|Baseline|Total|Total of all reporting groups
1092121|NCT00582738|B2|Baseline|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
1092122|NCT00582738|B1|Baseline|Standard Treatment|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
1092123|NCT00582738|P2|Participant Flow|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
1092124|NCT00582738|P1|Participant Flow|Standard Treatment|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
1092125|NCT00582738|O2|Outcome|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
1092129|NCT00582738|O4|Outcome|Everolimus - Summary of Fibrotest by Treatment|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
1092130|NCT00582738|O3|Outcome|Standard Treatment -Summary of Fibrotest by Treatment|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
1092131|NCT00582738|O2|Outcome|Everolimus -Summary of Actitest by Treatment|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
1092132|NCT00582738|O1|Outcome|Standard Treatment - Summary of Actitest by Treatment|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
1092133|NCT00582738|O2|Outcome|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
1092134|NCT00582738|O1|Outcome|CsA-TAC|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
1092135|NCT00582738|O2|Outcome|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
1092136|NCT00582738|O1|Outcome|CsA-TAC|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
1092137|NCT00582738|O2|Outcome|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
1092138|NCT00582738|O1|Outcome|CsA-TAC|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
1092139|NCT00582738|O2|Outcome|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
1092140|NCT00582738|O1|Outcome|CsA/TAC|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
1092141|NCT00582738|O2|Outcome|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
1092142|NCT00582738|O1|Outcome|CsA-TAC|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
1092143|NCT00582738|O2|Outcome|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
1092144|NCT00582738|O1|Outcome|CsA-TAC|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
1092145|NCT00582738|E2|Reported Event|EVR (Everolimus)|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
1092146|NCT00582738|E1|Reported Event|CsA/TAC|Continuation of current immunosuppressive regimen (continuation of CNI with or without MPA, with or without steroids) / no everolimus introduction.
1092147|NCT00582712|B1|Baseline|Lithium Capsules|Lithium carbonate: Lithium 300mg by mouth, three times daily, escalated to a lithium level of 0.8-1.2; Continued until progressive disease/unacceptable toxicity; Evaluated every 4 weeks.
1092153|NCT00582660|B1|Baseline|Celecoxib|400 mg BID given for 7 days before surgery
1092154|NCT00582660|P2|Participant Flow|Placebo|1 tablet BID given for 7 days before surgery
1092156|NCT00582660|O2|Outcome|Placebo|1 tablet BID given for 7 days before surgery
1092157|NCT00582660|O1|Outcome|Celecoxib|400 mg BID given for 7 days before surgery
1092158|NCT00582660|O2|Outcome|Placebo|1 tablet BID given for 7 days before surgery
1092159|NCT00582660|O1|Outcome|Celecoxib|400 mg BID given for 7 days before surgery
1092160|NCT00582660|E2|Reported Event|Placebo|1 tablet BID given for 7 days before surgery
1092161|NCT00582660|E1|Reported Event|Celecoxib|400 mg BID given for 7 days before surgery
1092162|NCT00582608|B1|Baseline|MAB 131-I LABELED 8H9|MAB 131-I LABELED 8H9: This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73 m2 dose [intended specific activity of ~20 mCi/mg protein] preceded by administration of 50mg/1.73m2 of unlabeled 8H9.
1092163|NCT00582608|P1|Participant Flow|MAB 131-I LABELED 8H9|MAB 131-I LABELED 8H9: This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73 m2 dose [intended specific activity of ~20 mCi/mg protein] preceded by administration of 50mg/1.73m2 of unlabeled 8H9.
1092164|NCT00582608|O1|Outcome|MAB 131-I LABELED 8H9|MAB 131-I LABELED 8H9: This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73 m2 dose [intended specific activity of ~20 mCi/mg protein] preceded by administration of 50mg/1.73m2 of unlabeled 8H9.
1092165|NCT00582608|E1|Reported Event|MAB 131-I LABELED 8H9|MAB 131-I LABELED 8H9: This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73 m2 dose [intended specific activity of ~20 mCi/mg protein] preceded by administration of 50mg/1.73m2 of unlabeled 8H9.
1092166|NCT00582556|B4|Baseline|Total|Total of all reporting groups
1092167|NCT00582556|B3|Baseline|Zometa Given Monthly x 6 Months|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
1092168|NCT00582556|B2|Baseline|Zometa Given at Month 6|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
1092169|NCT00582556|B1|Baseline|Zometa Given 7 Days Prior to Beginning ADT|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
1092170|NCT00582556|P3|Participant Flow|Zometa Given Monthly x 6 Months|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
1092171|NCT00582556|P2|Participant Flow|Zometa Given at Month 6|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
1092217|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
1092172|NCT00582556|P1|Participant Flow|Zometa Given 7 Days Prior to Beginning ADT|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
1092173|NCT00582556|O3|Outcome|Zometa Given Monthly, Months 6-11|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
1092174|NCT00582556|O2|Outcome|Zometa Given at Month 6|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
1092175|NCT00582556|O1|Outcome|Zometa Given 7 Days Prior to Beginning ADT|Gonadotropin releasing hormone (GnRH) analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
1092176|NCT00582556|O3|Outcome|Zometa Given Monthly, Months 6-11|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
1092177|NCT00582556|O2|Outcome|Zometa Given at Month 6|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
1092178|NCT00582556|O1|Outcome|Zometa Given 7 Days Prior to Beginning ADT|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
1092179|NCT00582556|O3|Outcome|Zometa Given Monthly, Months 6-11|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
1092180|NCT00582556|O2|Outcome|Zometa Given at Month 6|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
1092181|NCT00582556|O1|Outcome|Zometa Given 7 Days Prior to Beginning ADT|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
1092182|NCT00582556|O3|Outcome|Zometa Given Monthly, Months 6-11|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
1092183|NCT00582556|O2|Outcome|Zometa Given at Month 6|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
1092184|NCT00582556|O1|Outcome|Zometa Given 7 Days Prior to Beginning ADT|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
1092185|NCT00582556|E3|Reported Event|Zometa Given Monthly x 6 Months|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
1092186|NCT00582556|E2|Reported Event|Zometa Given at Month 6|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
1092187|NCT00582556|E1|Reported Event|Zometa Given 7 Days Prior to Beginning ADT|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
1092188|NCT00582517|B3|Baseline|Total|Total of all reporting groups
1092189|NCT00582517|B2|Baseline|Group B Compass Knee Hinge|Group B will have a Compass Knee Hinge placed
1092190|NCT00582517|B1|Baseline|Group A External Brace|Group A will have a non-invasive range of motion external brace placed following surgery
1092191|NCT00582517|P2|Participant Flow|Group B Compass Knee Hinge|Group B will have a Compass Knee Hinge placed
1092192|NCT00582517|P1|Participant Flow|Group A External Brace|Group A will have a non-invasive range of motion external brace placed following surgery
1092193|NCT00582517|O2|Outcome|Group B Compass Knee Hinge|Group B will have a Compass Knee Hinge placed. Stability of the knee determined by Continuous Passive Motion (CPM) machines and range of motion reached.
1092194|NCT00582517|O1|Outcome|Group A External Brace|Group A will have a non-invasive range of motion external brace placed following surgery. Stability of the knee determined by Continuous Passive Motion (CPM) machines and range of motion reached.
1092195|NCT00582517|E2|Reported Event|Group B Compass Knee Hinge|Group B will have a Compass Knee Hinge placed
1094453|NCT00577135|O3|Outcome|Low Intensification|
1092196|NCT00582517|E1|Reported Event|Group A External Brace|Group A will have a non-invasive range of motion external brace placed following surgery
1092197|NCT00582491|B3|Baseline|Total|Total of all reporting groups
1092198|NCT00582491|B2|Baseline|Placebo|Participants received a single oral placebo every morning for 16 days
1092199|NCT00582491|B1|Baseline|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
1092200|NCT00582491|P2|Participant Flow|Placebo|Placebo orally everyday for 16 days
1092201|NCT00582491|P1|Participant Flow|Modafinil 400mg|Modafinil 400mg orally everyday for 16 days
1092202|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
1092203|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
1092204|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
1092205|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
1092206|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
1092207|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
1092208|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
1092209|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
1092210|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
1092211|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
1092212|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
1092213|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
1092214|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
1092215|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
1092216|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
1092218|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
1092219|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
1092220|NCT00582491|E2|Reported Event|Placebo|Participants received a single oral placebo every morning for 16 days
1092221|NCT00582491|E1|Reported Event|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
1092222|NCT00582426|B3|Baseline|Total|Total of all reporting groups
1092223|NCT00582426|B2|Baseline|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
1092224|NCT00582426|B1|Baseline|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
1092225|NCT00582426|P2|Participant Flow|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
1092226|NCT00582426|P1|Participant Flow|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
1092227|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
1092228|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
1092229|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
1092230|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
1092231|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
1092232|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
1092233|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
1092234|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
1092235|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
1092236|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
1092237|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
1092238|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
1092239|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
1092240|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
1092241|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
1092242|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
1092243|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
1092575|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
1092244|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
1092245|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
1092246|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
1092247|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
1092248|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
1092249|NCT00582426|E2|Reported Event|Standard Treatment|
1092250|NCT00582426|E1|Reported Event|Octreotide LAR|
1092251|NCT00582400|B1|Baseline|Arsenic Trioxide|Patients with advanced measurable HCC, no more than one prior systemic treatment or no treatment, ECOG PS 0-2, and Child-Pugh class A received arsenic trioxide 0.35mg/kg on days 1, 8, 15 and 22 of each 28-day cycle.
1092252|NCT00582400|P1|Participant Flow|Arsenic Trioxide|Patients with advanced measurable HCC, no more than one prior systemic treatment or no treatment, ECOG PS 0-2, and Child-Pugh class A received arsenic trioxide 0.35mg/kg on days 1, 8, 15 and 22 of each 28-day cycle.
1092253|NCT00582400|O1|Outcome|Arsenic Trioxide|Patients with advanced measurable HCC, no more than one prior systemic treatment or no treatment, ECOG PS 0-2, and Child-Pugh class A received arsenic trioxide 0.35mg/kg on days 1, 8, 15 and 22 of each 28-day cycle.
1092254|NCT00582400|O1|Outcome|Arsenic Trioxide|Patients with advanced measurable HCC, no more than one prior systemic treatment or no treatment, ECOG PS 0-2, and Child-Pugh class A received arsenic trioxide 0.35mg/kg on days 1, 8, 15 and 22 of each 28-day cycle.
1092255|NCT00582400|O1|Outcome|Arsenic Trioxide|Patients with advanced measurable HCC, no more than one prior systemic treatment or no treatment, ECOG PS 0-2, and Child-Pugh class A received arsenic trioxide 0.35mg/kg on days 1, 8, 15 and 22 of each 28-day cycle.
1092256|NCT00582400|O1|Outcome|Arsenic Trioxide|Patients with advanced measurable HCC, no more than one prior systemic treatment or no treatment, ECOG PS 0-2, and Child-Pugh class A received arsenic trioxide 0.35mg/kg on days 1, 8, 15 and 22 of each 28-day cycle.
1092305|NCT00582036|B1|Baseline|Arm 1|Regular Sliding Scale Insulin per the following >400mg/dl = 12 units 351-400mg/dl = 10 units 301-350mg/dl = 8 units 251-300mg/dl = 6 units 200-250mg/dl = 4 units <200 No insulin
1092257|NCT00582400|E1|Reported Event|Arsenic Trioxide (Trisenox)|"arsenic trioxide: Trisenox will be diluted with 100 to 250 mL 0.9% Sodium Chloride injection, USP, using proper aseptic technique, immediately after withdrawal from the ampule. The Trisenox ampule is single-use and does not contain any preservatives. Unused portions of each ampule should be discarded properly. Trisenox is not to be mixed with other medications.~The loading dose of Trisenox will be administered intravenously over 2 hours. The infusion duration may be extended up to 4 hours if acute vasomotor reactions are observed. The drug will be administered IV through a functional peripheral or central venous line. Trisenox is not a vesicant, and may be a mild irritant if administered into the skin without dilution."
1092258|NCT00582361|B3|Baseline|Total|Total of all reporting groups
1092259|NCT00582361|B2|Baseline|Vacuum Assisted Closure Group (2, B)|Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
1092260|NCT00582361|B1|Baseline|Standard Dressing Group (1, A)|Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.
1092261|NCT00582361|P2|Participant Flow|Vacuum Assisted Closure Group (2, B)|Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
1092262|NCT00582361|P1|Participant Flow|Standard Dressing Group (1, A)|Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.
1092263|NCT00582361|O2|Outcome|Vacuum Assisted Closure Group (2, B)|Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
1092264|NCT00582361|O1|Outcome|Standard Dressing Group (1, A)|Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.
1092265|NCT00582361|O2|Outcome|Vacuum Assisted Closure Group (2, B)|Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
1092266|NCT00582361|O1|Outcome|Standard Dressing Group (1, A)|Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.
1092267|NCT00582361|E2|Reported Event|Vacuum Assisted Closure Group (2, B)|Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
1092268|NCT00582361|E1|Reported Event|Standard Dressing Group (1, A)|Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.
1092269|NCT00582309|B4|Baseline|Total|Total of all reporting groups
1092270|NCT00582309|B3|Baseline|Simple Calculated Intravenous Insulin Infusion|Simple Calculated Intravenous Insulin Infusion Use of of standard sliding scale to adjust insulin dose
1092271|NCT00582309|B2|Baseline|Standard Intravenous Insulin Infusion Algorithm|Standard Intravenous Insulin Infusion Algorithm Use of an algorithm the nurses follow based on previous glucoses and amount of insulin given is used to adjust the insulin dose
1092272|NCT00582309|B1|Baseline|Glucommander-Guided Intravenous Insulin Infusion|Glucommander-Guided Intravenous Insulin Infusion The use of a handheld devive with an alogorithm based on the previous glucoses and insulin given is used to adjust the next insulin dose
1092273|NCT00582309|P3|Participant Flow|Simple Calculated Intravenous Insulin Infusion|Simple Calculated Intravenous Insulin Infusion Use of of standard sliding scale to adjust insulin dose
1092274|NCT00582309|P2|Participant Flow|Standard Intravenous Insulin Infusion Algorithm|Standard Intravenous Insulin Infusion Algorithm Use of an algorithm the nurses follow based on previous glucoses and amount of insulin given is used to adjust the insulin dose
1092275|NCT00582309|P1|Participant Flow|Glucommander-Guided Intravenous Insulin Infusion|Glucommander-Guided Intravenous Insulin Infusion The use of a handheld devive with an alogorithm based on the previous glucoses and insulin given is used to adjust the next insulin dose
1092276|NCT00582309|O3|Outcome|Simple Calculated Intravenous Insulin Infusion|Simple Calculated Intravenous Insulin Infusion Use of of standard sliding scale to adjust insulin dose
1092420|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
1092277|NCT00582309|O2|Outcome|Standard Intravenous Insulin Infusion Algorithm|Standard Intravenous Insulin Infusion Algorithm Use of an algorithm the nurses follow based on previous glucoses and amount of insulin given is used to adjust the insulin dose
1092278|NCT00582309|O1|Outcome|Glucommander-Guided Intravenous Insulin Infusion|Glucommander-Guided Intravenous Insulin Infusion The use of a handheld devive with an alogorithm based on the previous glucoses and insulin given is used to adjust the next insulin dose
1092279|NCT00582309|E3|Reported Event|Simple Calculated Intravenous Insulin Infusion|Simple Calculated Intravenous Insulin Infusion Use of of standard sliding scale to adjust insulin dose
1092280|NCT00582309|E2|Reported Event|Standard Intravenous Insulin Infusion Algorithm|Standard Intravenous Insulin Infusion Algorithm Use of an algorithm the nurses follow based on previous glucoses and amount of insulin given is used to adjust the insulin dose
1092281|NCT00582309|E1|Reported Event|Glucommander-Guided Intravenous Insulin Infusion|Glucommander-Guided Intravenous Insulin Infusion The use of a handheld devive with an alogorithm based on the previous glucoses and insulin given is used to adjust the next insulin dose
1092282|NCT00582205|B1|Baseline|Paclitaxel, Cisplatin IP|"There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy~Paclitaxel, Cisplatin IP: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles"
1092283|NCT00582205|P1|Participant Flow|Paclitaxel, Cisplatin IP|"There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy~Paclitaxel, Cisplatin IP: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles"
1092284|NCT00582205|O1|Outcome|Paclitaxel, Cisplatin IP|"There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy~Paclitaxel, Cisplatin IP: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles"
1092285|NCT00582205|O1|Outcome|Paclitaxel, Cisplatin IP|"There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy~Paclitaxel, Cisplatin IP: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles"
1092811|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
1092286|NCT00582205|E1|Reported Event|Paclitaxel, Cisplatin IP|"There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy~Paclitaxel, Cisplatin IP: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles"
1092287|NCT00582114|B3|Baseline|Total|Total of all reporting groups
1092288|NCT00582114|B2|Baseline|Lisinopril|Lisinopril: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
1092289|NCT00582114|B1|Baseline|Atenolol|Atenolol: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
1092290|NCT00582114|P2|Participant Flow|Lisinopril|Lisinopril: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
1092291|NCT00582114|P1|Participant Flow|Atenolol|Atenolol: Patients will be randomized into two groups, one that is beta blocker based, the other angiotensin converting enzyme (ACE) inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
1092292|NCT00582114|O2|Outcome|Lisinopril|Lisinopril: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
1092293|NCT00582114|O1|Outcome|Atenolol|Atenolol: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
1092294|NCT00582114|O2|Outcome|Lisinopril|Lisinopril: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
1092295|NCT00582114|O1|Outcome|Atenolol|Atenolol: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
1092784|NCT00580788|B1|Baseline|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
1092296|NCT00582114|E2|Reported Event|Lisinopril|Lisinopril: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
1092297|NCT00582114|E1|Reported Event|Atenolol|Atenolol: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
1092298|NCT00582075|B1|Baseline|Radiosurgery 15-24 Gy + Adjuvant Temozolomide|Patients with newly diagnosed brain mets treated with radiosurgery.
1092299|NCT00582075|P1|Participant Flow|Radiosurgery 15-24 Gy + Adjuvant Temozolomide|Patients with newly diagnosed brain mets treated with radiosurgery.
1092300|NCT00582075|O1|Outcome|Radiosurgery 15-24 Gy + Adjuvant Temozolomide|Patients with newly diagnosed brain mets treated with radiosurgery.
1092301|NCT00582075|O1|Outcome|Radiosurgery 15-24 Gy + Adjuvant Temozolomide|Patients with newly diagnosed brain mets treated with radiosurgery.
1092302|NCT00582075|E1|Reported Event|Radiosurgery 15-24 Gy + Adjuvant Temozolomide|Patients with newly diagnosed brain mets treated with radiosurgery.
1092303|NCT00582036|B3|Baseline|Total|Total of all reporting groups
1092304|NCT00582036|B2|Baseline|Arm 2|"Baseline IV Insulin infusion begins with:~>220mg/dl - Start at 2 units/hr 110-220mg/dl - Start at 1 unit/hr <110 - Monitor fingerstick before meals and at bedtime~Sliding Scale IV Insulin adjustments based on:~>201mg/dl - Increase by 2 units/hr 141-200mg/dl - Increase by 1 unit/hr 111-140mg/dl - Increase by 0.5 units/hr 81 - 110mg/dl - If blood glucose decreases by 15mg/dl or more, reduce drip by 25% 61-80mg/dl - Reduce infusion by 25% <60 Stop infusion"
1092812|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
1092306|NCT00582036|P2|Participant Flow|Arm 2|"Baseline IV Insulin infusion begins with:~>220mg/dl - Start at 2 units/hr 110-220mg/dl - Start at 1 unit/hr <110 - Monitor fingerstick before meals and at bedtime~Sliding Scale IV Insulin adjustments based on:~>201mg/dl - Increase by 2 units/hr 141-200mg/dl - Increase by 1 unit/hr 111-140mg/dl - Increase by 0.5 units/hr 81 - 110mg/dl - If blood glucose decreases by 15mg/dl or more, reduce drip by 25% 61-80mg/dl - Reduce infusion by 25% <60 Stop infusion"
1092307|NCT00582036|P1|Participant Flow|Arm 1|Regular Sliding Scale Insulin per the following >400mg/dl = 12 units 351-400mg/dl = 10 units 301-350mg/dl = 8 units 251-300mg/dl = 6 units 200-250mg/dl = 4 units <200 No insulin
1092308|NCT00582036|O2|Outcome|Arm 2|"Baseline IV Insulin infusion begins with:~>220mg/dl - Start at 2 units/hr 110-220mg/dl - Start at 1 unit/hr <110 - Monitor fingerstick before meals and at bedtime~Sliding Scale IV Insulin adjustments based on:~>201mg/dl - Increase by 2 units/hr 141-200mg/dl - Increase by 1 unit/hr 111-140mg/dl - Increase by 0.5 units/hr 81 - 110mg/dl - If blood glucose decreases by 15mg/dl or more, reduce drip by 25% 61-80mg/dl - Reduce infusion by 25% <60 Stop infusion"
1092309|NCT00582036|O1|Outcome|Arm 1|Regular Sliding Scale Insulin per the following >400mg/dl = 12 units 351-400mg/dl = 10 units 301-350mg/dl = 8 units 251-300mg/dl = 6 units 200-250mg/dl = 4 units <200 No insulin
1092310|NCT00582036|E2|Reported Event|Arm 2|"Baseline IV Insulin infusion begins with:~>220mg/dl - Start at 2 units/hr 110-220mg/dl - Start at 1 unit/hr <110 - Monitor fingerstick before meals and at bedtime~Sliding Scale IV Insulin adjustments based on:~>201mg/dl - Increase by 2 units/hr 141-200mg/dl - Increase by 1 unit/hr 111-140mg/dl - Increase by 0.5 units/hr 81 - 110mg/dl - If blood glucose decreases by 15mg/dl or more, reduce drip by 25% 61-80mg/dl - Reduce infusion by 25% <60 Stop infusion"
1092311|NCT00582036|E1|Reported Event|Arm 1|Regular Sliding Scale Insulin per the following >400mg/dl = 12 units 351-400mg/dl = 10 units 301-350mg/dl = 8 units 251-300mg/dl = 6 units 200-250mg/dl = 4 units <200 No insulin
1092312|NCT00582010|B3|Baseline|Total|Total of all reporting groups
1092313|NCT00582010|B2|Baseline|Placebo (Nitrogen Gas)|80 ppm was administered by inhalation for the duration of surgery
1092314|NCT00582010|B1|Baseline|Inhaled Nitric Oxide|80 ppm was administered by inhalation for the duration of surgery
1092315|NCT00582010|P2|Participant Flow|2. Placebo|"Placebo (nitrogen)~nitrogen gas : inhaled"
1092316|NCT00582010|P1|Participant Flow|1. Experimental|"iNO administration~inhaled nitric oxide : inhaled 80ppm for duration of surgery."
1092317|NCT00582010|O2|Outcome|Placebo|
1092318|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
1092319|NCT00582010|O2|Outcome|Placebo|
1092320|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
1092321|NCT00582010|O2|Outcome|Placebo|
1092322|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
1092323|NCT00582010|O2|Outcome|Placebo|
1092324|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
1092325|NCT00582010|O2|Outcome|Placebo|
1092326|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
1092327|NCT00582010|O2|Outcome|Placebo|
1092328|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
1092329|NCT00582010|O2|Outcome|Placebo|
1092330|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
1092331|NCT00582010|O2|Outcome|Placebo|
1092332|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
1092333|NCT00582010|O2|Outcome|Placebo|
1092334|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
1092335|NCT00582010|E2|Reported Event|2. Placebo|"Placebo (nitrogen)~nitrogen gas : inhaled"
1092336|NCT00582010|E1|Reported Event|1. Experimental|"iNO administration~inhaled nitric oxide : inhaled 80ppm for duration of surgery."
1092337|NCT00581971|B1|Baseline|Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy|
1092365|NCT00581919|O1|Outcome|Bort, Dex, and Dox With ALCAR|Bort, Dex, and Dox with ALCAR: Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
1092338|NCT00581971|P1|Participant Flow|Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy|Patients with locally advanced head and neck cancer will be treated with weekly carboplatin, paclitaxel, and concurrent radiotherapy. Radiotherapy will be delivered at 1.8 Gy every day, to a maximum dose of 70.2 Gy. Carboplatin will be dosed at AUC=2.0, while paclitaxel will be dosed at 30mg/m2. Celecoxib will be delivered at 400mg twice daily, starting 1 week prior to the onset of radiotherapy to establish constant blood levels.
1092339|NCT00581971|O1|Outcome|Recurrence|
1092340|NCT00581971|O1|Outcome|Acute Toxicity|Participants that experienced Grade 3 or higher toxicity factors.
1092341|NCT00581971|E1|Reported Event|Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy|
1092342|NCT00581945|B3|Baseline|Total|Total of all reporting groups
1092343|NCT00581945|B2|Baseline|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
1092344|NCT00581945|B1|Baseline|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
1092345|NCT00581945|P2|Participant Flow|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
1092346|NCT00581945|P1|Participant Flow|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
1092347|NCT00581945|O2|Outcome|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
1092348|NCT00581945|O1|Outcome|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
1092813|NCT00580788|O4|Outcome|Group 4|PTHrP (1-36) 6 picomoles/kg/hr
1092349|NCT00581945|O2|Outcome|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
1092350|NCT00581945|O1|Outcome|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
1092351|NCT00581945|O2|Outcome|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
1092352|NCT00581945|O1|Outcome|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
1092353|NCT00581945|O2|Outcome|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
1092354|NCT00581945|O1|Outcome|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
1092355|NCT00581945|O2|Outcome|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
1092356|NCT00581945|O1|Outcome|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
1092357|NCT00581945|O2|Outcome|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
1092358|NCT00581945|O1|Outcome|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
1092359|NCT00581945|E2|Reported Event|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
1092360|NCT00581945|E1|Reported Event|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
1092361|NCT00581919|B1|Baseline|Bort, Dex, and Dox With ALCAR|Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
1092362|NCT00581919|P1|Participant Flow|Bort, Dex, and Dox With ALCAR|Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
1092363|NCT00581919|O1|Outcome|Bort, Dex, and Dox With ALCAR|Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
1092364|NCT00581919|O1|Outcome|Bort, Dex, and Dox With ALCAR|Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
1092419|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
1092366|NCT00581919|E1|Reported Event|Bort, Dex, and Dox With ALCAR|Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
1092367|NCT00581867|B1|Baseline|Entire Study Population|Includes groups randomized to receive placebo first and insulin first.
1092368|NCT00581867|P2|Participant Flow|Intranasal Insulin First, Then Placebo|Participants in this group were randomized to receive Intranasal Insulin at the first fMRI visit and then received Placebo at the second fMRI visit.
1092369|NCT00581867|P1|Participant Flow|Placebo First, Then Intranasal Insulin|Participants in this group were randomized to receive placebo at the first fMRI visit and then received Intranasal Insulin at the second fMRI visit.
1092370|NCT00581867|O2|Outcome|Placebo|
1092371|NCT00581867|O1|Outcome|Intranasal Insulin Aspart|
1092372|NCT00581867|O2|Outcome|Placebo|
1092373|NCT00581867|O1|Outcome|Intranasal Insulin Aspart|
1092374|NCT00581867|E2|Reported Event|Placebo|Placebo was administered in either first or second intervention period.
1092375|NCT00581867|E1|Reported Event|Intranasal Insulin Aspart|Intranasal Insulin was administered in either first or second intervention period.
1092376|NCT00581854|B1|Baseline|Group 1|SAEs during induction therapy
1092377|NCT00581854|P1|Participant Flow|Rituximab|Single Arm Maintenance rituximab following induction chemoimmunotherapy
1092378|NCT00581854|O1|Outcome|Group 1|All subjects received R-HyperCVAD induction therapy.
1092379|NCT00581854|E1|Reported Event|Group 1|SAEs during induction therapy
1092380|NCT00581828|B1|Baseline|Vitamin D|Subjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months).
1092381|NCT00581828|P1|Participant Flow|Vitamin D|Subjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months).
1092382|NCT00581828|O1|Outcome|Vitamin D|Subjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months).
1092814|NCT00580788|O3|Outcome|Group 3|PTHrP (1-36) 5 pmol/kg/hr
1092383|NCT00581828|E1|Reported Event|Vitamin D|Subjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months).
1092384|NCT00581776|B1|Baseline|VCR-CVAD With Rituximab Maintenance|
1092385|NCT00581776|P1|Participant Flow|VCR-CVAD With Rituximab Maintenance|
1092386|NCT00581776|O1|Outcome|VCR-CVAD With Rituximab Maintenance|
1092387|NCT00581776|O1|Outcome|VCR-CVAD With Rituximab Maintenance|
1092388|NCT00581776|O1|Outcome|VCR-CVAD With Rituximab Maintenance|
1092389|NCT00581776|O1|Outcome|VCR-CVAD With Rituximab Maintenance|
1092390|NCT00581776|E1|Reported Event|VCR-CVAD With Rituximab Maintenance|
1092391|NCT00581581|B3|Baseline|Total|Total of all reporting groups
1092392|NCT00581581|B2|Baseline|Standard Care|Randomized to standard care (original RCT)
1092393|NCT00581581|B1|Baseline|Therapeutic Hypothermia|Randomized to cooling (original RCT)
1092394|NCT00581581|P2|Participant Flow|Standard Care|Randomized to standard care (original RCT)
1092395|NCT00581581|P1|Participant Flow|Therapeutic Hypothermia|Randomized to cooling (original RCT)
1092396|NCT00581581|O2|Outcome|Standard Care|Randomized to standard care (original RCT)
1092397|NCT00581581|O1|Outcome|Therapeutic Hypothermia|Randomized to cooling (original RCT)
1092398|NCT00581581|E2|Reported Event|Standard Care|Randomized to standard care (original RCT)
1092399|NCT00581581|E1|Reported Event|Therapeutic Hypothermia|Randomized to cooling (original RCT)
1092400|NCT00581555|B3|Baseline|Total|Total of all reporting groups
1092401|NCT00581555|B2|Baseline|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
1092402|NCT00581555|B1|Baseline|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
1092403|NCT00581555|P2|Participant Flow|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
1092404|NCT00581555|P1|Participant Flow|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
1092405|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
1092406|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
1092407|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
1092408|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
1092409|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
1092410|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
1092411|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
1092412|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
1092413|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
1092414|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
1092415|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
1092416|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
1092417|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
1092418|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
1092421|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
1092422|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
1092423|NCT00581555|E2|Reported Event|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
1092424|NCT00581555|E1|Reported Event|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
1092425|NCT00581542|B3|Baseline|Total|Total of all reporting groups
1092426|NCT00581542|B2|Baseline|Moxifloxacin Ophthalmic Solution|randomization to topical moxifloxacin
1092427|NCT00581542|B1|Baseline|Polytrim Ophthalmic Solution|randomization to topical polytrim
1092428|NCT00581542|P2|Participant Flow|Moxifloxin Group|Randomization to topical moxifloxacin 1-2 drops 3x/day for 8-10 days
1092429|NCT00581542|P1|Participant Flow|Polytrim Group|Randomization to polytrim : 1-2 drops four times a day for 8-10 days.
1092430|NCT00581542|O2|Outcome|Polytrim Group|Randomization to polytrim : 1-2 drops four times a day for 8-10 days.
1092431|NCT00581542|O1|Outcome|Moxifloxin Group|Randomization to topical moxifloxacin 1-2 drops 3x/day for 8-10 days
1092432|NCT00581542|O2|Outcome|Moxifloxacin|
1092433|NCT00581542|O1|Outcome|Polytrim Arm|
1092434|NCT00581542|E2|Reported Event|Polytrim Treatment Group|
1092435|NCT00581542|E1|Reported Event|Moxifloxacin Treatment Group|
1092436|NCT00581529|B1|Baseline|Radiotherapy|Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
1092437|NCT00581529|P1|Participant Flow|Radiotherapy|Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
1092474|NCT00581386|O3|Outcome|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
1092438|NCT00581529|O1|Outcome|Radiotherapy|"Accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.~IMRT: Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy."
1092439|NCT00581529|O1|Outcome|Radiotherapy|"Accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.~IMRT: Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy."
1092440|NCT00581529|E1|Reported Event|Radiotherapy|Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
1092441|NCT00581399|B3|Baseline|Total|Total of all reporting groups
1092442|NCT00581399|B2|Baseline|Standard of Care Chest Tubes|Standard of Care 36 Fr Chest Tubes connected to a Pleur-evac Chest Drainage System for Mediastinal Space Drainage.
1092443|NCT00581399|B1|Baseline|No-NumoChest Tubes|High Vacuum Chest Tubes 13Fr for Pleural Drainage and 22Fr connected to a Vario High Vacuum Pump (Medela) for Mediastinal Space Drainage.
1092444|NCT00581399|P2|Participant Flow|Standard of Care Chest Tubes|Standard of Care 36 Fr Chest Tubes connected to a Pleur-evac Chest Drainage System for Mediastinal Space Drainage.
1092445|NCT00581399|P1|Participant Flow|No-NumoChest Tubes|High Vacuum Chest Tubes 13Fr for Pleural Drainage and 22Fr connected to a Vario High Vacuum Pump (Medela) for Mediastinal Space Drainage.
1092446|NCT00581399|O2|Outcome|Standard of Care Chest Tubes|Standard of Care 36 Fr Chest Tubes connected to a Pleur-evac Chest Drainage System for Mediastinal Space Drainage.
1092447|NCT00581399|O1|Outcome|No-NumoChest Tubes|High Vacuum Chest Tubes 13Fr for Pleural Drainage and 22Fr connected to a Vario High Vacuum Pump (Medela) for Mediastinal Space Drainage.
1092448|NCT00581399|O2|Outcome|Standard of Care Chest Tubes|Standard of Care 36 Fr Chest Tubes connected to a Pleur-evac Chest Drainage System for Mediastinal Space Drainage.
1092449|NCT00581399|O1|Outcome|No-NumoChest Tubes|High Vacuum Chest Tubes 13Fr for Pleural Drainage and 22Fr connected to a Vario High Vacuum Pump (Medela) for Mediastinal Space Drainage.
1092450|NCT00581399|E2|Reported Event|Standard of Care Chest Tubes|Standard of Care 36 Fr Chest Tubes connected to a Pleur-evac Chest Drainage System for Mediastinal Space Drainage.
1092451|NCT00581399|E1|Reported Event|No-NumoChest Tubes|High Vacuum Chest Tubes 13Fr for Pleural Drainage and 22Fr connected to a Vario High Vacuum Pump (Medela) for Mediastinal Space Drainage.
1092452|NCT00581386|B4|Baseline|Total|Total of all reporting groups
1092453|NCT00581386|B3|Baseline|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
1092454|NCT00581386|B2|Baseline|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
1092455|NCT00581386|B1|Baseline|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
1092456|NCT00581386|P3|Participant Flow|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
1092457|NCT00581386|P2|Participant Flow|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
1092458|NCT00581386|P1|Participant Flow|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
1092459|NCT00581386|O3|Outcome|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
1092460|NCT00581386|O2|Outcome|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
1092461|NCT00581386|O1|Outcome|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
1092462|NCT00581386|O3|Outcome|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
1092785|NCT00580788|P4|Participant Flow|Group 4|PTHrP (1-36) 6 picomoles/kg/hr
1092463|NCT00581386|O2|Outcome|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
1092464|NCT00581386|O1|Outcome|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
1092465|NCT00581386|O3|Outcome|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
1092466|NCT00581386|O2|Outcome|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
1092467|NCT00581386|O1|Outcome|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
1092468|NCT00581386|O3|Outcome|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
1092469|NCT00581386|O2|Outcome|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
1092470|NCT00581386|O1|Outcome|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
1092471|NCT00581386|O3|Outcome|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
1092472|NCT00581386|O2|Outcome|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
1092473|NCT00581386|O1|Outcome|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
1092815|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr
1092475|NCT00581386|O2|Outcome|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
1092476|NCT00581386|O1|Outcome|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
1092477|NCT00581386|E3|Reported Event|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
1092478|NCT00581386|E2|Reported Event|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
1092479|NCT00581386|E1|Reported Event|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
1092480|NCT00581360|B1|Baseline|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
1092481|NCT00581360|P1|Participant Flow|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
1092482|NCT00581360|O1|Outcome|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
1092483|NCT00581360|O1|Outcome|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
1092484|NCT00581360|O1|Outcome|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
1092485|NCT00581360|O1|Outcome|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
1092486|NCT00581360|O1|Outcome|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
1092487|NCT00581360|E1|Reported Event|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
1092488|NCT00581347|B3|Baseline|Total|Total of all reporting groups
1092489|NCT00581347|B2|Baseline|Standard of Care|Control subjects received standard of care. All practices routinely sent letter or telephone reminders to families who had upcoming scheduled visits, but none used active reminder/recall based on vaccinations.
1092490|NCT00581347|B1|Baseline|Outreach|"The intervention consisted of a tiered protocol, with each step being more intensive and targeting a progressively smaller proportion of adolescents who remained behind in immunizations. The intervention was delivered by trained patient immunization navigators.~Step 1- Patient tracking: We used a web-based database to track the adolescents in the intervention group, record immunizations and preventive visits, and document tasks they performed.~Step 2: Reminders and recall: The navigators performed reminder/recall for adolescents who were eligible for either a vaccination or a preventive care visit. They attempted to contact families by telephone and mail.~Step 3: Home visits: If adolescents remained unvaccinated despite the above steps, the navigators performed a home visit to further assess barriers, promote the importance of preventive care, and encourage families to make appointments."
1092491|NCT00581347|P2|Participant Flow|Standard of Care|Control subjects received standard of care. All practices routinely sent letter or telephone reminders to families who had upcoming scheduled visits, but none used active reminder/recall based on vaccinations.
1092492|NCT00581347|P1|Participant Flow|Outreach|"The intervention consisted of a tiered protocol, with each step being more intensive and targeting a progressively smaller proportion of adolescents who remained behind in immunizations. The intervention was delivered by trained patient immunization navigators.~Step 1- Patient tracking: We used a web-based database to track the adolescents in the intervention group, record immunizations and preventive visits, and document tasks they performed.~Step 2: Reminders and recall: The navigators performed reminder/recall for adolescents who were eligible for either a vaccination or a preventive care visit. They attempted to contact families by telephone and mail.~Step 3: Home visits: If adolescents remained unvaccinated despite the above steps, the navigators performed a home visit to further assess barriers, promote the importance of preventive care, and encourage families to make appointments."
1092786|NCT00580788|P3|Participant Flow|Group 3|PTHrP (1-36) 5 pmol/kg/hr
1092493|NCT00581347|O2|Outcome|Standard of Care|Control subjects received standard of care. All practices routinely sent letter or telephone reminders to families who had upcoming scheduled visits, but none used active reminder/recall based on vaccinations.
1092494|NCT00581347|O1|Outcome|Outreach|"The intervention consisted of a tiered protocol, with each step being more intensive and targeting a progressively smaller proportion of adolescents who remained behind in immunizations. The intervention was delivered by trained patient immunization navigators.~Step 1- Patient tracking: We used a web-based database to track the adolescents in the intervention group, record immunizations and preventive visits, and document tasks they performed.~Step 2: Reminders and recall: The navigators performed reminder/recall for adolescents who were eligible for either a vaccination or a preventive care visit. They attempted to contact families by telephone and mail.~Step 3: Home visits: If adolescents remained unvaccinated despite the above steps, the navigators performed a home visit to further assess barriers, promote the importance of preventive care, and encourage families to make appointments."
1092495|NCT00581347|O2|Outcome|Standard of Care|Control subjects received standard of care. All practices routinely sent letter or telephone reminders to families who had upcoming scheduled visits, but none used active reminder/recall based on vaccinations.
1092496|NCT00581347|O1|Outcome|Outreach|"The intervention consisted of a tiered protocol, with each step being more intensive and targeting a progressively smaller proportion of adolescents who remained behind in immunizations. The intervention was delivered by trained patient immunization navigators.~Step 1- Patient tracking: We used a web-based database to track the adolescents in the intervention group, record immunizations and preventive visits, and document tasks they performed.~Step 2: Reminders and recall: The navigators performed reminder/recall for adolescents who were eligible for either a vaccination or a preventive care visit. They attempted to contact families by telephone and mail.~Step 3: Home visits: If adolescents remained unvaccinated despite the above steps, the navigators performed a home visit to further assess barriers, promote the importance of preventive care, and encourage families to make appointments."
1092816|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr
1092497|NCT00581347|E2|Reported Event|Standard of Care|Control subjects received standard of care. All practices routinely sent letter or telephone reminders to families who had upcoming scheduled visits, but none used active reminder/recall based on vaccinations.
1092498|NCT00581347|E1|Reported Event|Outreach|"The intervention consisted of a tiered protocol, with each step being more intensive and targeting a progressively smaller proportion of adolescents who remained behind in immunizations. The intervention was delivered by trained patient immunization navigators.~Step 1- Patient tracking: We used a web-based database to track the adolescents in the intervention group, record immunizations and preventive visits, and document tasks they performed.~Step 2: Reminders and recall: The navigators performed reminder/recall for adolescents who were eligible for either a vaccination or a preventive care visit. They attempted to contact families by telephone and mail.~Step 3: Home visits: If adolescents remained unvaccinated despite the above steps, the navigators performed a home visit to further assess barriers, promote the importance of preventive care, and encourage families to make appointments."
1092499|NCT00581308|B1|Baseline|PAS Subjects|Subjects with occluder in place upon leaving cath lab
1092500|NCT00581308|P1|Participant Flow|PAS Subjects|Subjects with occluder in place upon leaving cath lab
1092501|NCT00581308|O1|Outcome|PAS Subjects|Subjects with occluder in place upon leaving cath lab
1092502|NCT00581308|O1|Outcome|PAS Subjects|Subjects with occluder in place upon leaving cath lab
1092503|NCT00581308|O1|Outcome|PAS Subjects|Subjects with occluder in place upon leaving cath lab
1092504|NCT00581308|O1|Outcome|PAS Subjects|Subjects with occluder in place upon leaving cath lab
1092505|NCT00581308|O1|Outcome|PAS Subjects|Subjects with occluder in place upon leaving cath lab
1092506|NCT00581308|E1|Reported Event|PAS Subjects|Subjects with occluder in place upon leaving cath lab
1092507|NCT00581256|B3|Baseline|Total|Total of all reporting groups
1092508|NCT00581256|B2|Baseline|3DRT|"Best 3-dimensional standard PWTF technique~3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease"
1092509|NCT00581256|B1|Baseline|IMRT|"Best Delivery-optimized radiotherapy technique (IMRT)~IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume."
1092510|NCT00581256|P2|Participant Flow|3DRT|"Best 3-dimensional standard PWTF technique~3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease"
1092511|NCT00581256|P1|Participant Flow|IMRT|"Best Delivery-optimized radiotherapy technique (IMRT)~IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume."
1092512|NCT00581256|O2|Outcome|3DRT|"Best 3-dimensional standard PWTF technique~3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease"
1092574|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
1094454|NCT00577135|O2|Outcome|Continuous Infusion|
1092513|NCT00581256|O1|Outcome|IMRT|"Best Delivery-optimized radiotherapy technique (IMRT)~IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume."
1092514|NCT00581256|O2|Outcome|3DRT|"Best 3-dimensional standard PWTF technique~3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease"
1092515|NCT00581256|O1|Outcome|IMRT|"Best Delivery-optimized radiotherapy technique (IMRT)~IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume."
1092516|NCT00581256|O2|Outcome|3DRT|"Best 3-dimensional standard PWTF technique~3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease"
1092542|NCT00581100|B1|Baseline|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
1092817|NCT00580788|O4|Outcome|Group 4|PTHrP (1-36) 6 picomoles/kg/hr
1092517|NCT00581256|O1|Outcome|IMRT|"Best Delivery-optimized radiotherapy technique (IMRT)~IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume."
1092518|NCT00581256|O2|Outcome|3DRT|"Best 3-dimensional standard PWTF technique~3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease"
1092519|NCT00581256|O1|Outcome|IMRT|"Best Delivery-optimized radiotherapy technique (IMRT)~IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume."
1092520|NCT00581256|E2|Reported Event|3DRT|"Best 3-dimensional standard PWTF technique~3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease"
1092521|NCT00581256|E1|Reported Event|IMRT|"Best Delivery-optimized radiotherapy technique (IMRT)~IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume."
1092522|NCT00581230|B1|Baseline|Laryngoscopy Without RAMP, Then Laryngoscopy With RAMP|First, laryngoscopy was preformed utilizing a traditional Macintosh size 4 blade laryngoscope (without the Rapid Airway Management Positioner (RAMP)). The view of the laryngeal aperture was recorded, and a photo was taken by the Airway Cam™. Second, the Rapid Airway Management Positioner (RAMP) was positioned and inflated underneath the patient so that the patient was placed in the optimal sniffing position. The investigator again performed laryngoscopy utilizing the same technique, the second time with RAMP, and the laryngeal view was recorded.
1092523|NCT00581230|P1|Participant Flow|Entire Study|All the patients first underwent mask ventilation and laryngoscopy with Macintosh size 4 blade laryngoscope without RAMP. Second, all patients underwent laryngoscopy with RAMP--the RAMP pillow was inflated for all patients and the ease of Mask ventilation and Cormack Lehane laryngoscopy view with Macintosh size 4 laryngoscope was recorded.
1092524|NCT00581230|O2|Outcome|Laryngoscopy With RAMP|The Cormack Lehane grade glottic view obtained during laryngoscopy with inflated RAMP pillow. In all participants, laryngoscopy with the Rapid Airway Management Positioner (RAMP) was performed second (after Laryngoscopy without RAMP). The RAMP was positioned and inflated underneath the patient so that the patient was placed in the optimal sniffing position. The investigator again performed laryngoscopy utilizing the same technique, except that RAMP was used, and the laryngeal view was recorded.
1092525|NCT00581230|O1|Outcome|Laryngoscopy Without RAMP|The Cormack Lehane grade view obtained with laryngoscopy when there was no RAMP pillow. In all participants, laryngoscopy was first performed utilizing a traditional Macintosh size 4 blade laryngoscope (without the Rapid Airway Management Postitioner (RAMP)). The view of the laryngeal aperture was recorded, and a photo was taken by the Airway Cam™.
1092526|NCT00581230|O2|Outcome|Laryngoscopy With RAMP|In this crossover study, all participants then received laryngoscopy with the Rapid Airway Management Positioner (RAMP) (immediately after Laryngoscopy without RAMP). The RAMP was positioned and inflated underneath the patient so that the patient was placed in the optimal sniffing position. The investigator again performed laryngoscopy utilizing the same technique, except that RAMP was used, and the laryngeal view was recorded.
1092527|NCT00581230|O1|Outcome|Laryngoscopy Without RAMP|In all participants, laryngoscopy was first performed utilizing a traditional Macintosh size 4 blade laryngoscope (without the Rapid Airway Management Postitioner (RAMP)). The view of the laryngeal aperture was recorded, and a photo was taken by the Airway Cam™.
1092787|NCT00580788|P2|Participant Flow|Group 2|PTHrP(1-36) 4 picomoles/kg/hr
1092528|NCT00581230|E1|Reported Event|Entire Study|This is a crossover study, all the patients 1st underwent mask ventilation and laryngoscopy with Macintosh size 4 blade laryngoscope. After this, the RAMP pillow was inflated for all patients and the ease of Mask ventilation and Cormack Lehane laryngoscopy view with Macintosh size 4 laryngoscope was recorded.
1092529|NCT00581113|B3|Baseline|Total|Total of all reporting groups
1092530|NCT00581113|B2|Baseline|Standard Whole Brain RT|Standard Whole Brain Radiotherapy
1092531|NCT00581113|B1|Baseline|Neural Stem Cell-Preserving Whole Brain RT|Neural Stem Cell-Preserving Whole Brain Radiotherapy
1092532|NCT00581113|P2|Participant Flow|Standard Whole Brain RT|Standard Whole Brain Radiotherapy
1092533|NCT00581113|P1|Participant Flow|Neural Stem Cell-Preserving Whole Brain RT|Neural Stem Cell-Preserving Whole Brain Radiotherapy
1092534|NCT00581113|O2|Outcome|Standard Whole Brain RT|Standard Whole Brain RT
1092535|NCT00581113|O1|Outcome|Neural Stem Cell-Preserving Whole Brain RT|Neural Stem Cell-Preserving Whole Brain Radiotherapy
1092536|NCT00581113|O2|Outcome|Standard Whole Brain RT|Standard Whole Brain RT
1092537|NCT00581113|O1|Outcome|Neural Stem Cell-Preserving Whole Brain RT|Neural Stem Cell-Preserving Whole Brain Radiotherapy
1092538|NCT00581113|E2|Reported Event|Standard Whole Brain RT|Standard Whole Brain RT
1092539|NCT00581113|E1|Reported Event|Neural Stem Cell-Preserving Whole Brain RT|Neural Stem Cell-Preserving Whole Brain Radiotherapy
1092540|NCT00581100|B3|Baseline|Total|Total of all reporting groups
1092541|NCT00581100|B2|Baseline|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
1092543|NCT00581100|P2|Participant Flow|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
1092544|NCT00581100|P1|Participant Flow|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
1092545|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
1092546|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
1092547|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
1092548|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
1092549|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
1092550|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
1092551|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
1092552|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
1092553|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
1092554|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
1092555|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
1092556|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
1092557|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
1092558|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
1092559|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
1092560|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
1092561|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
1092562|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
1092563|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
1092564|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
1092565|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
1092566|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
1092567|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
1092568|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
1092569|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
1092570|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
1092571|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
1092572|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
1092573|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
1092576|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
1092577|NCT00581100|E2|Reported Event|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
1092578|NCT00581100|E1|Reported Event|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
1092579|NCT00581061|B1|Baseline|Vesicare|Number of subjects that were in compliance with the study protocol and took medication for at least one month.
1092580|NCT00581061|P1|Participant Flow|Vesicare|Number of subjects that were in compliance with the study protocol and took medication for at least one month.
1092581|NCT00581061|O1|Outcome|Vesicare|Number of people who experienced side effects while taking Vesicare, per study protocol. These are known side effects indicated on the drug label that occur to subjects on this medication.
1092582|NCT00581061|O1|Outcome|Vesicare|Number of subjects that were in compliance with the study protocol and took medication for at least one month.
1092583|NCT00581061|O1|Outcome|Vesicare|Number of days it takes for subjects to achieve pad free urinary continence
1092584|NCT00581061|E1|Reported Event|Vesicare|Number of subjects that were in compliance with the study protocol and took medication for at least one month.
1092585|NCT00580983|B1|Baseline|Chemo-IMRT|"Chemotherapy:~Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days.~Intensity-modulated Radiation Therapy (IMRT):~Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions.~Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions."
1092586|NCT00580983|P1|Participant Flow|Chemo-IMRT|"Chemotherapy:~Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days.~Intensity-modulated Radiation Therapy (IMRT):~Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions.~Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions."
1092587|NCT00580983|O1|Outcome|Chemo-IMRT|"Chemotherapy:~Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days.~Intensity-modulated Radiation Therapy (IMRT):~Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions.~Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions."
1092588|NCT00580983|O1|Outcome|Chemo-IMRT|"Chemotherapy:~Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days.~Intensity-modulated Radiation Therapy (IMRT):~Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions.~Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions."
1092589|NCT00580983|E1|Reported Event|Chemo-IMRT|"Chemotherapy:~Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days.~Intensity-modulated Radiation Therapy (IMRT):~Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions.~Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions."
1092590|NCT00580970|B3|Baseline|Total|Total of all reporting groups
1092591|NCT00580970|B2|Baseline|Supportive Care (Lovastatin) (Ineligible)|The 20 subjects started Lovastatin on the first day of radiation (either EBRT,external beam radiotherapy, or on the day of brachytherapy). The subjects were ineligible because they did not complete 6 months of Lovastatin.
1092592|NCT00580970|B1|Baseline|Supportive Care (Lovastatin) (Evaluable)|The 53 subjects started Lovastatin treatment on the first day of radiation (either EBRT,external beam radiotherapy, or on the day of brachytherapy) and continued up to 12 months. The subjects were considered evaluable for analysis because they completed 6 months of Lovastatin.
1092593|NCT00580970|P1|Participant Flow|Supportive Care (Lovastatin)|"Subjects took Lovastatin on the first day of radiation (either EBRT,external beam radiotherapy, or on the day of brachytherapy) and continued for 12 months.~73 subjects enrolled in the study, 72 started treatment, 20 subjects were ineligible for analysis, and a total of 53 evaluable subjects."
1092594|NCT00580970|O1|Outcome|Supportive Care (Lovastatin) (Evaluable)|The 53 subjects started Lovastatin treatment on the first day of radiation (either EBRT,external beam radiotherapy, or on the day of brachytherapy) and continued up to 12 months. The subjects were considered evaluable for analysis because they completed 6 months of Lovastatin.
1092595|NCT00580970|E1|Reported Event|Supportive Care (Lovastatin)|"Subjects who started treatment on Lovastatin on the first day of radiation therapy (external beam radiation therapy (EBRT) alone, brachytherapy alone, or EBRT followed by brachytherapy).~73 subjects enrolled in the study, 72 started Lovastatin treatment, 20 subjects were ineligible for analysis, and a total of 53 subjects evaluable for analysis. 72 subjects started treatment and were at risk for Adverse Events (AEs) and Serious Adverse Events(SAEs)."
1092596|NCT00580957|B3|Baseline|Total|Total of all reporting groups
1092597|NCT00580957|B2|Baseline|Intact Then Blocked|"Saline will be used instead of trimethaphan during insulin clamp~Intact: Saline IV infusion to simulate trimethaphan infusion in active arm Insulin clamp will be done to determine insulin resistance"
1092666|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
1092598|NCT00580957|B1|Baseline|Blocked Then Intact|"Active treatment arm. Transient autonomic blockade with Trimethaphan and blood pressure restoration with L-NMMA will be used during insulin clamp~Blocked: Trimethaphan 4 mg/min IV will be infused for the duration of the study.~L-NMMA 125-500 mcg/k/min IV will be titrated to restore blood pressure to pre-trimethaphan levels Insulin clamp will be used to determine insulin resistance"
1092599|NCT00580957|P2|Participant Flow|Intact|"Saline will be used instead of trimethaphan during insulin clamp~Intact: Saline IV infusion to simulate trimethaphan infusion in active arm Insulin clamp will be done to determine insulin resistance"
1092600|NCT00580957|P1|Participant Flow|Blocked|"Active treatment arm. Transient autonomic blockade with Trimethaphan and blood pressure restoration with L-NMMA will be used during insulin clamp~Blocked: Trimethaphan 4 mg/min IV will be infused for the duration of the study.~L-NMMA 125-500 mcg/k/min IV will be titrated to restore blood pressure to pre-trimethaphan levels Insulin clamp will be used to determine insulin resistance"
1092601|NCT00580957|O2|Outcome|Intact|"Saline will be used instead of trimethaphan during insulin clamp~Intact: Saline IV infusion to simulate trimethaphan infusion in active arm Insulin clamp will be done to determine insulin resistance"
1092602|NCT00580957|O1|Outcome|Blocked|"Active treatment arm. Transient autonomic blockade with Trimethaphan and blood pressure restoration with L-NMMA will be used during insulin clamp~Blocked: Trimethaphan 4 mg/min IV will be infused for the duration of the study.~L-NMMA 125-500 mcg/k/min IV will be titrated to restore blood pressure to pre-trimethaphan levels Insulin clamp will be used to determine insulin resistance"
1092603|NCT00580957|E2|Reported Event|Intact|"Saline will be used instead of trimethaphan during insulin clamp~Intact: Saline IV infusion to simulate trimethaphan infusion in active arm Insulin clamp will be done to determine insulin resistance"
1092641|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
1092604|NCT00580957|E1|Reported Event|Blocked|"Active treatment arm. Transient autonomic blockade with Trimethaphan and blood pressure restoration with L-NMMA will be used during insulin clamp~Blocked: Trimethaphan 4 mg/min IV will be infused for the duration of the study.~L-NMMA 125-500 mcg/k/min IV will be titrated to restore blood pressure to pre-trimethaphan levels Insulin clamp will be used to determine insulin resistance"
1092605|NCT00580866|B3|Baseline|Total|Total of all reporting groups
1092606|NCT00580866|B2|Baseline|PT Only Group|
1092607|NCT00580866|B1|Baseline|Brace Group|JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.
1092608|NCT00580866|P2|Participant Flow|PT Only Group|
1092609|NCT00580866|P1|Participant Flow|Brace Group|JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.
1092610|NCT00580866|O2|Outcome|PT Only Group|
1092611|NCT00580866|O1|Outcome|Brace Group|JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.
1092612|NCT00580866|O2|Outcome|PT Only Group|
1092613|NCT00580866|O1|Outcome|Brace Group|JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.
1092614|NCT00580866|E2|Reported Event|PT Only Group|
1092615|NCT00580866|E1|Reported Event|Brace Group|JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.
1092616|NCT00580853|B4|Baseline|Total|Total of all reporting groups
1092617|NCT00580853|B3|Baseline|Placebo|"Placebo Control~Placebo: Placebo"
1092618|NCT00580853|B2|Baseline|Bupropion|"Bupropion 300mg/day~bupropion: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8)."
1092619|NCT00580853|B1|Baseline|Varenicline|"varenicline 2mg/day~varenicline: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8)."
1092620|NCT00580853|P3|Participant Flow|Placebo|"Placebo Control~Placebo: Placebo"
1092621|NCT00580853|P2|Participant Flow|Bupropion|"Bupropion 300mg/day~bupropion: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8)."
1092622|NCT00580853|P1|Participant Flow|Varenicline|"varenicline 2mg/day~varenicline: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8)."
1092623|NCT00580853|O3|Outcome|Placebo|"Placebo Control~Placebo: Placebo"
1092624|NCT00580853|O2|Outcome|Bupropion|"Bupropion 300mg/day~bupropion: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8)."
1092625|NCT00580853|O1|Outcome|Varenicline|"varenicline 2mg/day~varenicline: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8)."
1092626|NCT00580853|O3|Outcome|Placebo|"Placebo Control~Placebo: Placebo"
1092627|NCT00580853|O2|Outcome|Bupropion|"Bupropion 300mg/day~bupropion: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8)."
1092628|NCT00580853|O1|Outcome|Varenicline|"varenicline 2mg/day~varenicline: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8)."
1092629|NCT00580853|E3|Reported Event|Placebo|"Placebo Control~Placebo: Placebo"
1092630|NCT00580853|E2|Reported Event|Bupropion|"Bupropion 300mg/day~bupropion: 300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8)."
1092667|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
1092631|NCT00580853|E1|Reported Event|Varenicline|"varenicline 2mg/day~varenicline: 2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8)."
1092632|NCT00580840|B1|Baseline|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
1092633|NCT00580840|P4|Participant Flow|PLO + MTX|Placebo (PTO) + Methotrexate (MTX)
1092634|NCT00580840|P3|Participant Flow|CZP 200 mg and PLO + MTX|Certolizumab Pegol (CZP) 200 mg and Placebo (PLO) + Methotrexate (MTX)
1092635|NCT00580840|P2|Participant Flow|CZP 400 mg and PLO + MTX|Certolizumab Pegol (CZP) 400 mg and Placebo (PLO) + Methotrexate (MTX)
1092636|NCT00580840|P1|Participant Flow|Overall|Overall for the Run-in period includes all 333 subjects that entered the study. Overall for the Double-blind period includes all 209 subjects that completed the Run-in period.
1092637|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
1092638|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
1092639|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
1092640|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
1092818|NCT00580788|O3|Outcome|Group 3|PTHrP (1-36) 5 pmol/kg/hr
1092642|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
1092643|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
1092644|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
1092645|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
1092646|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
1092647|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
1092648|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
1092649|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
1092650|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
1092651|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
1092652|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
1092653|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
1092654|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
1092655|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
1092656|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
1092657|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
1092658|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
1092659|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
1092660|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
1092661|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
1092662|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
1092663|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
1092664|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
1092665|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
1092668|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
1092669|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
1092670|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
1092671|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
1092672|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
1092673|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
1092674|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
1092675|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
1092676|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
1092677|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
1092678|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
1092679|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
1092680|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
1092681|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
1092682|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
1092683|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
1092684|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
1092685|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
1092686|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
1092687|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
1092688|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
1092689|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
1092690|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
1092691|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
1092692|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
1092693|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
1092694|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
1092695|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
1092696|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
1092697|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
1092698|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
1092699|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
1092700|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
1094455|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
1092701|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
1092702|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
1092703|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
1092704|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
1092705|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
1092706|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
1092707|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
1092708|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
1092709|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
1092710|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
1092711|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
1092712|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
1092713|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
1092714|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
1092715|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
1092716|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
1092717|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
1092718|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
1092719|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
1092720|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
1092721|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
1092722|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
1092723|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
1092724|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
1092725|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
1092726|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
1092727|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
1092728|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
1092729|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
1092730|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
1092731|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
1092732|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
1092733|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
1092734|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
1092735|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
1092736|NCT00580840|E4|Reported Event|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
1092737|NCT00580840|E3|Reported Event|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
1092782|NCT00580788|B3|Baseline|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
1092783|NCT00580788|B2|Baseline|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
1092738|NCT00580840|E2|Reported Event|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
1092739|NCT00580840|E1|Reported Event|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
1092740|NCT00580801|B4|Baseline|Total|Total of all reporting groups
1092741|NCT00580801|B3|Baseline|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
1092742|NCT00580801|B2|Baseline|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
1092743|NCT00580801|B1|Baseline|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
1092744|NCT00580801|P3|Participant Flow|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
1092806|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
1092807|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
1092745|NCT00580801|P2|Participant Flow|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
1092746|NCT00580801|P1|Participant Flow|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
1092747|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
1092748|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
1092749|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
1092750|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
1092751|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
1092752|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
1092753|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
1092754|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
1092755|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
1092756|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
1092757|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
1092758|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
1092759|NCT00580801|O3|Outcome|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
1092760|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
1092761|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
1092762|NCT00580801|O3|Outcome|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
1092763|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
1092764|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
1092808|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
1092765|NCT00580801|O3|Outcome|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
1092766|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
1092767|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
1092768|NCT00580801|O3|Outcome|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
1092769|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
1092770|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
1092771|NCT00580801|O3|Outcome|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
1092772|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
1092773|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
1092774|NCT00580801|O3|Outcome|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
1092775|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
1092776|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
1092777|NCT00580801|E3|Reported Event|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
1092778|NCT00580801|E2|Reported Event|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
1092779|NCT00580801|E1|Reported Event|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
1092780|NCT00580788|B5|Baseline|Total|Total of all reporting groups
1092781|NCT00580788|B4|Baseline|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
1092788|NCT00580788|P1|Participant Flow|Group 1|PTHrP(1-36) 2 picomoles/kg/hr
1092789|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week
1092790|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week
1092791|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week
1092792|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
1092793|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
1092794|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
1092795|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
1092796|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
1092797|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
1092798|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
1092799|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
1092800|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
1092801|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
1092802|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
1092803|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
1092804|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
1092805|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
1092819|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr
1092823|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr
1092824|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr
1092825|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week
1092826|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week
1092827|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week
1092828|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
1092829|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week
1092830|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week
1092831|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week
1092832|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
1092833|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
1092834|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
1092835|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
1092836|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
1092837|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week
1092838|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week
1092839|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week
1092840|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
1092841|NCT00580788|E4|Reported Event|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
1092842|NCT00580788|E3|Reported Event|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
1092843|NCT00580788|E2|Reported Event|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
1092844|NCT00580788|E1|Reported Event|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
1092845|NCT00580723|B1|Baseline|Topical PRK 124|Topical PRK 124 (Pyratine-6)(0.125%)
1092846|NCT00580723|P1|Participant Flow|Topical PRK 124|Topical PRK 124 (Pyratine-6)(0.125%)
1092847|NCT00580723|O1|Outcome|Topical PRK 124|Topical PRK 124 (Pyratine-6)(0.125%)
1092848|NCT00580723|O1|Outcome|Topical PRK 124|Topical PRK 124 (Pyratine-6)(0.125%)
1092849|NCT00580723|O1|Outcome|Topical PRK 124|Topical PRK 124 (Pyratine-6)(0.125%)
1092850|NCT00580723|E1|Reported Event|Topical PRK 124|Topical PRK 124 (Pyratine-6)(0.125%)
1092851|NCT00580671|B4|Baseline|Total|Total of all reporting groups
1092852|NCT00580671|B3|Baseline|MET/CBT|Motivational Enhancement Therapy (MET)/CBT
1092853|NCT00580671|B2|Baseline|MET/CBT+CM|Motivational Enhancement Therapy (MET)/CBT+CM
1092854|NCT00580671|B1|Baseline|MET/CBT+CM/BPT|Motivational Enhancement Therapy (MET)/CBT+CM/BPT
1092855|NCT00580671|P3|Participant Flow|MET/CBT|Motivational Enhancement Therapy (MET)/CBT
1092856|NCT00580671|P2|Participant Flow|MET/CBT+CM|Motivational Enhancement Therapy (MET)/CBT+CM
1092857|NCT00580671|P1|Participant Flow|MET/CBT+CM/BPT|Motivational Enhancement Therapy (MET)/ Cognitive Behavior Therapy (CBT) + Contingency Management (CM) / Behavioral Parent Training (BPT)
1092858|NCT00580671|O3|Outcome|MET/CBT|Motivational Enhancement Therapy (MET)/CBT
1092859|NCT00580671|O2|Outcome|MET/CBT+CM|Motivational Enhancement Therapy (MET)/CBT+CM
1092860|NCT00580671|O1|Outcome|MET/CBT+CM/BPT|Motivational Enhancement Therapy (MET)/CBT+CM/BPT
1092861|NCT00580671|O3|Outcome|MET/CBT|Motivational Enhancement Therapy (MET)/CBT
1092862|NCT00580671|O2|Outcome|MET/CBT+CM|Motivational Enhancement Therapy (MET)/CBT+CM
1092863|NCT00580671|O1|Outcome|MET/CBT+CM/BPT|Motivational Enhancement Therapy (MET)/CBT+CM/BPT
1092864|NCT00580671|O3|Outcome|MET/CBT|Motivational Enhancement Therapy (MET)/CBT
1092865|NCT00580671|O2|Outcome|MET/CBT+CM|Motivational Enhancement Therapy (MET)/CBT+CM
1092866|NCT00580671|O1|Outcome|MET/CBT+CM/BPT|Motivational Enhancement Therapy (MET)/CBT+CM/BPT
1092867|NCT00580671|E3|Reported Event|MET/CBT|Motivational Enhancement Therapy (MET)/CBT
1092868|NCT00580671|E2|Reported Event|MET/CBT+CM|Motivational Enhancement Therapy (MET)/CBT+CM
1092869|NCT00580671|E1|Reported Event|MET/CBT+CM/BPT|Motivational Enhancement Therapy (MET)/CBT+CM/BPT
1092870|NCT00580606|B3|Baseline|Total|Total of all reporting groups
1092871|NCT00580606|B2|Baseline|Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over and receive open label high dose peanut SLIT; the study procedures and schedule are the same as for the Low Dose Peanut SLIT group, the only difference is the maximum maintenance dose is almost 3-fold higher at 3,696 mcg/day. DB=Double Blind, SLIT=Sublingual Immunotherapy, OL=Open Label.
1092872|NCT00580606|B1|Baseline|Low Dose Peanut SLIT (Double Blind to Open Label)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at the Week 116 OFC are unable to consume >= 5,000 mg peanut powder or 10-fold the amount of peanut powder compared to the baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
1092882|NCT00580606|O2|Outcome|Placebo (Double Blind)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy
1093915|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
1092873|NCT00580606|P2|Participant Flow|Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over and receive open label high dose peanut SLIT; the study procedures and schedule are the same as for the Low Dose Peanut SLIT group, the only difference is the maximum maintenance dose is almost 3-fold higher at 3,696 mcg/day. DB=Double Blind, SLIT=Sublingual Immunotherapy, OL=Open Label.
1092874|NCT00580606|P1|Participant Flow|Low Dose Peanut SLIT (Double Blind to Open Label)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at the Week 116 OFC are unable to consume >= 5,000 mg peanut powder or 10-fold the amount of peanut powder compared to the baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
1092875|NCT00580606|O2|Outcome|Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over and receive open label high dose peanut SLIT; the study procedures and schedule are the same as for the Low Dose Peanut SLIT group, the only difference is the maximum maintenance dose is almost 3-fold higher at 3,696 mcg/day. DB=Double Blind, SLIT=Sublingual Immunotherapy, OL=Open Label.
1092876|NCT00580606|O1|Outcome|Low Dose Peanut SLIT (Double Blind to Open Label)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at the Week 116 OFC are unable to consume >= 5,000 mg peanut powder or 10-fold the amount of peanut powder compared to the baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
1092877|NCT00580606|O1|Outcome|High Dose Peanut SLIT Crossover (Open Label)|Subjects ingest open label peanut protein (glycerinated peanut allergenic extract) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 3,696 mcg) for >= 8 weeks. After Week 44 of open label therapy, subjects either continue on their peanut protein maintenance dose of 3,696 mcg per day or are allowed to attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy.
1092878|NCT00580606|O2|Outcome|Placebo (Double Blind)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy
1092879|NCT00580606|O1|Outcome|Low Dose Peanut SLIT (Double Blind)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy
1092880|NCT00580606|O1|Outcome|High Dose Peanut SLIT Crossover (Open Label)|Subjects ingest open label peanut protein (glycerinated peanut allergenic extract) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 3,696 mcg) for >= 8 weeks. After Week 44 of open label therapy, subjects either continue on their peanut protein maintenance dose of 3,696 mcg per day or are allowed to attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy.
1092881|NCT00580606|O1|Outcome|High Dose Peanut SLIT Crossover (Open Label)|Subjects ingest open label peanut protein (glycerinated peanut allergenic extract) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 3,696 mcg) for >= 8 weeks. After Week 44 of open label therapy, subjects either continue on their peanut protein maintenance dose of 3,696 mcg per day or are allowed to attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy.
1092902|NCT00580398|P1|Participant Flow|Control|Usual care included physician advice to quit smoking.
1092903|NCT00580398|O2|Outcome|Intervention|12-week program consisting of varenicline (1mg bid, with initial titration up over week 1) and smoking cessation counseling sessions targeted to the issues of thoracic cancer patients.
1092904|NCT00580398|O1|Outcome|Control|Usual care included physician advice to quit smoking.
1092883|NCT00580606|O1|Outcome|Low Dose Peanut SLIT (Double Blind)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy
1092884|NCT00580606|O2|Outcome|Placebo (Double Blind)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy, mcg=microgram
1092885|NCT00580606|O1|Outcome|Low Dose Peanut SLIT (Double Blind)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy, mcg=microgram
1092886|NCT00580606|E5|Reported Event|Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)|After 44 weeks of open label therapy, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. After completion of this Week 44 OFC, subjects then either continue on their peanut protein maintenance dose of 3,696 mcg per day or are allowed to attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
1092887|NCT00580606|E4|Reported Event|Low Dose Peanut SLIT (Double Blind to Open Label)|After completion of the 5,000 mg Oral Food Challenge (OFC) at Week 44, subjects/study staff are unblinded and subjects continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
1092888|NCT00580606|E3|Reported Event|High Dose Peanut SLIT Crossover Before Wk44 Crossover OFC (OL)|Subjects ingest open label peanut protein (glycerinated peanut allergenic extract) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 3,696 mcg) for >= 8 weeks. After 44 weeks of open label SLIT, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. SLIT=Sublingual Immunotherapy
1092889|NCT00580606|E2|Reported Event|Placebo Before Week 44 OFC (Double Blind)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy
1093004|NCT00579813|O1|Outcome|Obese Subjects, Baseline|Baseline studies, obese
1093064|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
1092890|NCT00580606|E1|Reported Event|Low Dose Peanut SLIT Before Week 44 OFC (Double Blind)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy
1092891|NCT00580502|B1|Baseline|LAP-BAND® Adjustable Gastric Band (LAGB®) Operations|A prospective study to evaluate the safety and efficacy of LAP-BAND® Adjustable Gastric Band (LAGB®) operations for patients with BMI between 30-40 kg/m2 with co-morbidities
1092892|NCT00580502|P1|Participant Flow|Lap-Band|"Low BMI patients who will go through Lap-band surgery.~LAP-BAND® Adjustable Gastric Band (LAGB®): Bariatric surgery: LAGB"
1092893|NCT00580502|O1|Outcome|LAGB|LAGB surgery for the patient whose BMI between 30 and 40 kg/m^2
1092894|NCT00580502|O1|Outcome|LAGB|LAGB surgery for the patient whose BMI between 30 and 40 kg/m^2
1092895|NCT00580502|O1|Outcome|LAGB|LAGB surgery for the patient whose BMI between 30 and 40 kg/m^2
1092896|NCT00580502|O1|Outcome|LAGB|LAGB surgery for the patient whose BMI between 30 and 40 kg/m^2
1092897|NCT00580502|E1|Reported Event|LAP-BAND® Adjustable Gastric Band (LAGB®) Operations|A prospective study to evaluate the safety and efficacy of LAP-BAND® Adjustable Gastric Band (LAGB®) operations for patients with BMI between 30-40 kg/m2 with co-morbidities
1092898|NCT00580398|B3|Baseline|Total|Total of all reporting groups
1092899|NCT00580398|B2|Baseline|Intervention|12-week program consisting of varenicline (1mg bid, with initial titration up over week 1) and smoking cessation counseling sessions targeted to the issues of thoracic cancer patients.
1092900|NCT00580398|B1|Baseline|Control|Usual care included physician advice to quit smoking.
1092901|NCT00580398|P2|Participant Flow|Intervention|Intervention participants were provided with a 12-week program consisting of varenicline (1mg bid, with initial titration up over week 1) and smoking cessation counseling targeted to the issues of thoracic cancer patients. We had proposed to offer 7 counseling sessions but were flexible in offering additional sessions when needed. The counseling was delivered by a certified Tobacco Treatment Counselor using motivational interviewing (MI) techniques.
1092905|NCT00580398|O2|Outcome|Intervention|12-week program consisting of varenicline (1mg bid, with initial titration up over week 1) and smoking cessation counseling sessions targeted to the issues of thoracic cancer patients.
1092906|NCT00580398|O1|Outcome|Control|Usual care included physician advice to quit smoking.
1092907|NCT00580398|E2|Reported Event|Intervention|12-week program consisting of varenicline (1mg bid, with initial titration up over week 1) and smoking cessation counseling sessions targeted to the issues of thoracic cancer patients.
1092908|NCT00580398|E1|Reported Event|Control|Usual care included physician advice to quit smoking.
1092909|NCT00580372|B1|Baseline|Study Treatment|"Protocol therapy consists of a remission induction phase with mutually non-cross resistant combinations of vincristine, adriamycin, dexamethasone (VAD), high-dose cyclophosphamide with stem cell procurement and etoposide, dexamethasone, cytarabine, cisplatin (EDAP) followed by two courses of melphalan-based high-dose therapy supported by autologous stem cell transplants 4-6 months apart. Maintenance with interferon alpha will be administered until disease progression.~VAD: 3 Cycles (3rd cycle optional):~Vincristine 0.5 mg/d d 1 – 4 CI Adriamycin 10 mg/m2/d d 1 – 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20~High-Dose cyclophosphamide: Approximately 5-6 weeks after VAD 2 or 3:~Cytoxan 1.2g/m2/d d 1 – 5 Mesna 3.6 g/m2 d 1~Hemopoietic stem cell procurement: Collection target = 10 x 10^6 cells/kg~EDAP: Approximately 5-6 weeks after high-dose cyclophosphamide"
1092910|NCT00580372|P1|Participant Flow|Study Treatment|"Protocol therapy consists of a remission induction phase with mutually non-cross resistant combinations of vincristine, adriamycin, dexamethasone (VAD), high-dose cyclophosphamide with stem cell procurement and etoposide, dexamethasone, cytarabine, cisplatin (EDAP) followed by two courses of melphalan-based high-dose therapy supported by autologous stem cell transplants 4-6 months apart. Maintenance with interferon alpha will be administered until disease progression.~VAD: 3 Cycles (3rd cycle optional):~Vincristine 0.5 mg/d d 1 – 4 CI Adriamycin 10 mg/m2/d d 1 – 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20~High-Dose cyclophosphamide: Approximately 5-6 weeks after VAD 2 or 3:~Cytoxan 1.2g/m2/d d 1 – 5 Mesna 3.6 g/m2 d 1~Hemopoietic stem cell procurement: Collection target = 10 x 10^6 cells/kg~EDAP: Approximately 5-6 weeks after high-dose cyclophosphamide"
1092911|NCT00580372|O1|Outcome|Study Treatment|"Protocol therapy consists of a remission induction phase with mutually non-cross resistant combinations of vincristine, adriamycin, dexamethasone (VAD), high-dose cyclophosphamide with stem cell procurement and etoposide, dexamethasone, cytarabine, cisplatin (EDAP) followed by two courses of melphalan-based high-dose therapy supported by autologous stem cell transplants 4-6 months apart. Maintenance with interferon alpha will be administered until disease progression.~VAD: 3 Cycles (3rd cycle optional):~Vincristine 0.5 mg/d d 1 – 4 CI Adriamycin 10 mg/m2/d d 1 – 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20~High-Dose cyclophosphamide: Approximately 5-6 weeks after VAD 2 or 3:~Cytoxan 1.2g/m2/d d 1 – 5 Mesna 3.6 g/m2 d 1~Hemopoietic stem cell procurement: Collection target = 10 x 10^6 cells/kg~EDAP: Approximately 5-6 weeks after high-dose cyclophosphamide"
1092912|NCT00580372|E1|Reported Event|Study Treatment|"Protocol therapy consists of a remission induction phase with mutually non-cross resistant combinations of vincristine, adriamycin, dexamethasone (VAD), high-dose cyclophosphamide with stem cell procurement and etoposide, dexamethasone, cytarabine, cisplatin (EDAP) followed by two courses of melphalan-based high-dose therapy supported by autologous stem cell transplants 4-6 months apart. Maintenance with interferon alpha will be administered until disease progression.~VAD: 3 Cycles (3rd cycle optional):~Vincristine 0.5 mg/d d 1 – 4 CI Adriamycin 10 mg/m2/d d 1 – 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20~High-Dose cyclophosphamide: Approximately 5-6 weeks after VAD 2 or 3:~Cytoxan 1.2g/m2/d d 1 – 5 Mesna 3.6 g/m2 d 1~Hemopoietic stem cell procurement: Collection target = 10 x 10^6 cells/kg~EDAP: Approximately 5-6 weeks after high-dose cyclophosphamide"
1092913|NCT00580333|B1|Baseline|Cisplatin/Avastin|"Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional)~cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles~bevacizumab: Preoperatively: Given IV on day 1 of the treatment cycle (once every three weeks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel~doxorubicin: Postoperative: Given intravenously for four 2-week cycles~cyclophosphamide: Postoperative: Given intravenously for four two-week cycles~paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two weeks)"
1092914|NCT00580333|P1|Participant Flow|Cisplatin/Avastin|"cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles~bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three weeks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel~doxorubicin: Postoperative: Given intravenously for four 2-week cycles~cyclophosphamide: Postoperative: Given intravenously for four two-week cycles~paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two weeks)"
1092915|NCT00580333|O1|Outcome|Cisplatin/Avastin|"Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional), cyclophosphamide , adjuvant (optional), paclitaxel, adjuvant (optional)~cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles~bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every 3 weeks) for 3 cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel~doxorubicin: Postoperative: Given intravenously for four 2-week cycles~cyclophosphamide: Postoperative: Given intravenously for four two-week cycles~paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week"
1092937|NCT00580151|E2|Reported Event|Control Group|placebo : 1 dose every 6 hours
1092938|NCT00580151|E1|Reported Event|Experimental Group|clonidine : 3-5 microgram per kilogram every 6 hours for 10 days
1092939|NCT00580138|B1|Baseline|Stroke or Head & Neck Cancer|Any subject who has suffered a stroke or has some form of head & neck cancer (non-laryngectomee) may be enrolled.
1094107|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
1092916|NCT00580333|O1|Outcome|Cisplatin/Avastin|"Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional), cyclophosphamide , adjuvant (optional), paclitaxel, adjuvant (optional)~cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles~bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every 3 weeks) for 3 cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel~doxorubicin: Postoperative: Given intravenously for four 2-week cycles~cyclophosphamide: Postoperative: Given intravenously for four two-week cycles~paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week"
1092917|NCT00580333|O1|Outcome|Cisplatin/Avastin|"Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional), cyclophosphamide , adjuvant (optional), paclitaxel, adjuvant (optional)~cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles~bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every 3 weeks) for 3 cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel~doxorubicin: Postoperative: Given intravenously for four 2-week cycles~cyclophosphamide: Postoperative: Given intravenously for four two-week cycles~paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week"
1092918|NCT00580333|O1|Outcome|Cisplatin/Avastin|"Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional)~cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 wks) for four cycles~bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three wks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel~doxorubicin: Postoperative: Given intravenously for four 2-week cycles~cyclophosphamide: Postoperative: Given intravenously for four two-week cycles~paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week"
1092919|NCT00580333|E1|Reported Event|Cisplatin/Avastin|"Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional)~cisplatin: Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 wks) for four cycles~bevacizumab: Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three wks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel~doxorubicin: Postoperative: Given intravenously for four 2-week cycles~cyclophosphamide: Postoperative: Given intravenously for four two-week cycles~paclitaxel: Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two week"
1092920|NCT00580294|B1|Baseline|Oxymorphone|oral oxymorphone ER as the basal opioid during the first 24 hours and supplemental IV-PCA oxymorphone as needed during period 1. During period 2, participants underwent a 2-week oral titration. The oxymorphone ER and IR dosages were adjusted up or down as needed to maintain pain control.
1092921|NCT00580294|P1|Participant Flow|Oxymorphone|participants switched to oxymorphone extended release (ER) via both oral and intravenous patient-controlled analgesia (IV-PCA) oxymorphone. After 24 hours, participants were discharged with oral oxymorphone ER and oxymorphone immediate release (IR) as needed
1093063|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
1092922|NCT00580294|O1|Outcome|Oxymorphone|oral oxymorphone ER as the basal opioid during the first 24 hours and supplemental IV-PCA oxymorphone as needed during period 1. During period 2, participants underwent a 2-week oral titration. The oxymorphone ER and IR dosages were adjusted up or down as needed to maintain pain control.
1092923|NCT00580294|E1|Reported Event|Oxymorphone|oral oxymorphone ER as the basal opioid during the first 24 hours and supplemental IV-PCA oxymorphone as needed during period 1. During period 2, participants underwent a 2-week oral titration. The oxymorphone ER and IR dosages were adjusted up or down as needed to maintain pain control.
1092924|NCT00580229|B1|Baseline|Oral Prednisone as a Pretreatment to Rituximab|40mg of oral prednisone given 30 min prior to rituximab as a prophylaxis against acute infusion reactions(AIR), as an alternative to the intravenous methylprednisone as a pretreatment for rituximab.
1092925|NCT00580229|P1|Participant Flow|Oral Prednisone as a Pretreatment to Rituximab|40mg of oral prednisone given 30 min prior to rituximab as a prophylaxis against acute infusion reactions(AIR), as an alternative to the intravenous methylprednisone as a pretreatment for rituximab.
1092926|NCT00580229|O1|Outcome|Oral Prednisone as a Pretreatment to Rituximab|40mg of oral prednisone given 30 min prior to rituximab as a prophylaxis against acute infusion reactions(AIR), as an alternative to the intravenous methylprednisone as a pretreatment for rituximab.
1092927|NCT00580229|E1|Reported Event|Oral Prednisone as a Pretreatment to Rituximab|40mg of oral prednisone given 30 min prior to rituximab as a prophylaxis against acute infusion reactions(AIR), as an alternative to the intravenous methylprednisone as a pretreatment for rituximab.
1092928|NCT00580151|B3|Baseline|Total|Total of all reporting groups
1092929|NCT00580151|B2|Baseline|Control Group|placebo : 1 dose every 6 hours
1092930|NCT00580151|B1|Baseline|Experimental Group|clonidine : 3-5 microgram per kilogram every 6 hours for 10 days
1092931|NCT00580151|P2|Participant Flow|Control Group|placebo : 1 dose every 6 hours
1092932|NCT00580151|P1|Participant Flow|Experimental Group|clonidine : 3-5 microgram per kilogram every 6 hours for 10 days
1092933|NCT00580151|O2|Outcome|Control Group|placebo : 1 dose every 6 hours
1092934|NCT00580151|O1|Outcome|Experimental Group|clonidine : 3-5 microgram per kilogram every 6 hours for 10 days
1092935|NCT00580151|O2|Outcome|Control Group|placebo : 1 dose every 6 hours
1092936|NCT00580151|O1|Outcome|Experimental Group|clonidine : 3-5 microgram per kilogram every 6 hours for 10 days
1092940|NCT00580138|P1|Participant Flow|Stroke or Head & Neck Cancer|Any subject who has suffered a stroke or has some form of head & neck cancer (non-laryngectomee) may be enrolled.
1092941|NCT00580138|O1|Outcome|Stroke or Head & Neck Cancer|Any subject who has suffered a stroke or has some form of head & neck cancer (non-laryngectomee) may be enrolled.
1092942|NCT00580138|E1|Reported Event|Stroke or Head & Neck Cancer|Any subject who has suffered a stroke or has some form of head & neck cancer (non-laryngectomee) may be enrolled.
1092943|NCT00580073|B1|Baseline|FOLFOX4 + Cetuximab|"FOLFOX4: oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle)~Cetuximab: Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8, 15, and 22 of each cycle."
1092944|NCT00580073|P1|Participant Flow|FOLFOX4 + Cetuximab|"FOLFOX4: oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU (5-fluorouracil) Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle)~Cetuximab: Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8, 15, and 22 of each cycle."
1092945|NCT00580073|O1|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4: oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle)~Cetuximab: Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8, 15, and 22 of each cycle."
1092946|NCT00580073|O1|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4: oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle)~Cetuximab: Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8, 15, and 22 of each cycle."
1092947|NCT00580073|O1|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4: oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle)~Cetuximab: Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8, 15, and 22 of each cycle."
1092948|NCT00580073|E1|Reported Event|FOLFOX4 + Cetuximab|"FOLFOX4: oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle)~Cetuximab: Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8, 15, and 22 of each cycle."
1092949|NCT00580034|B1|Baseline|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative ASCT in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte macrophage colony stimulating factor (GM-CSF) 15 mcg/kg/d sc or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45."
1092963|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
1093126|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
1092950|NCT00580034|P2|Participant Flow|Donor Apheresis|"Donor must be a sibling, half sibling, parent, child or first cousin familial relationship and 3-5/6 Human Leukocyte Antigen matched related to subject. They must not have any medical condition which would make apheresis and G-CSF administration more than a minimal risk, and should have the following:~Adequate cardiac function by history and physical examination~bilirubin and hepatic transaminases < 2.5 x upper limit of normal~normal hematologic parameters Females should have a negative serum pregnancy test."
1092951|NCT00580034|P1|Participant Flow|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative allogeneic stem cell transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously(dose will be rounded to the nearest whole vial size and may be divided into bid dosing). Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45."
1092952|NCT00580034|O1|Outcome|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative allogeneic stem cell transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45."
1092973|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
1092974|NCT00579982|E1|Reported Event|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
1092975|NCT00579826|B3|Baseline|Total|Total of all reporting groups
1094108|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
1092953|NCT00580034|O1|Outcome|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative allogeneic stem cell transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45."
1092954|NCT00580034|O1|Outcome|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative allogeneic stem cell transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45."
1092955|NCT00580034|E1|Reported Event|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative ASCT in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte macrophage colony stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneously or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45."
1092956|NCT00579982|B1|Baseline|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
1092957|NCT00579982|P1|Participant Flow|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
1092958|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
1092959|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
1092960|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
1092961|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
1092962|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
1093002|NCT00579813|O3|Outcome|Lean Subjects, Baseline|lean subjects, baseline
1093003|NCT00579813|O2|Outcome|After Pioiglitazone|10 weeks of treatment
1092964|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
1092965|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
1092966|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
1092967|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
1092968|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
1092969|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
1092970|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
1092971|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
1092972|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
1092976|NCT00579826|B2|Baseline|Placebo|"Placebo, daily for 6 months~Placebo: Placebo tablet daily for 6 months then optional open label letrozole for 6 months."
1092977|NCT00579826|B1|Baseline|Letrozole|"Letrozole, 2.5 mg daily for 6 months~Letrozole: Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months."
1092978|NCT00579826|P2|Participant Flow|Placebo|"Placebo, daily for 6 months~Placebo: Placebo tablet daily for 6 months then optional open label letrozole for 6 months."
1092979|NCT00579826|P1|Participant Flow|Letrozole|"Letrozole, 2.5 mg daily for 6 months~Letrozole: Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months."
1092980|NCT00579826|O2|Outcome|Placebo|"Placebo, daily for 6 months~Placebo: Placebo tablet daily for 6 months then optional open label letrozole for 6 months."
1092981|NCT00579826|O1|Outcome|Letrozole|"Letrozole, 2.5 mg daily for 6 months~Letrozole: Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months."
1092982|NCT00579826|O2|Outcome|Placebo|"Placebo, daily for 6 months~Placebo: Placebo tablet daily for 6 months then optional open label letrozole for 6 months."
1092983|NCT00579826|O1|Outcome|Letrozole|"Letrozole, 2.5 mg daily for 6 months~Letrozole: Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months."
1092984|NCT00579826|O2|Outcome|Placebo|"Placebo, daily for 6 months~Placebo: Placebo tablet daily for 6 months then optional open label letrozole for 6 months."
1092985|NCT00579826|O1|Outcome|Letrozole|"Letrozole, 2.5 mg daily for 6 months~Letrozole: Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months."
1092986|NCT00579826|E2|Reported Event|Placebo for 6 Months; Open Label Letrozole 2.5 mg Daily|"Placebo, daily for 6 months~Placebo: Placebo tablet daily for 6 months then optional open label letrozole for 6 months."
1092987|NCT00579826|E1|Reported Event|Letrozole, 2.5 mg Daily for 12 Months|"Letrozole, 2.5 mg daily for 6 months~Letrozole: Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months."
1092988|NCT00579813|B3|Baseline|Total|Total of all reporting groups
1092989|NCT00579813|B2|Baseline|Obese Subjects|Baseline studies (Oral glucose tolerance test, Dual energy x-ray absorbiometry, Resting metabolic rate, Frequently sampled intravenous glucose tolerance test, biopsies), then 10 weeks treatment on Pioglitazone. Baseline tests are repeated at the end of medication treatment.
1092990|NCT00579813|B1|Baseline|Lean Subjects|Arm 1 was normal subjects on which baseline studies were performed to determine insulin sensitivity, intramyocellular lipid and resting metabolic rate.
1092991|NCT00579813|P2|Participant Flow|Obese Subjects|Baseline studies (Oral glucose tolerance test, Dual energy x-ray absorbiometry, Resting metabolic rate, Frequently sampled intravenous glucose tolerance test, biopsies), then 10 weeks treatment on Pioglitazone. Baseline tests are repeated at the end of medication treatment.
1092992|NCT00579813|P1|Participant Flow|Lean Subjects|Arm 1 was normal subjects on which baseline studies were performed to determine insulin sensitivity, intramyocellular lipid and resting metabolic rate.
1092993|NCT00579813|O3|Outcome|Lean Subjects, Baseline|lean subjects, baseline
1092994|NCT00579813|O2|Outcome|After Pioiglitazone|10 weeks of treatment
1092995|NCT00579813|O1|Outcome|Obese Subjects, Baseline|Baseline studies, obese
1092996|NCT00579813|O3|Outcome|Lean Subjects, Baseline|lean subjects, baseline
1092997|NCT00579813|O2|Outcome|After Pioiglitazone|10 weeks of treatment
1092998|NCT00579813|O1|Outcome|Obese Subjects, Baseline|Baseline studies, obese
1092999|NCT00579813|O3|Outcome|Lean Subjects, Baseline|lean subjects, baseline
1093000|NCT00579813|O2|Outcome|After Pioiglitazone|10 weeks of treatment
1093001|NCT00579813|O1|Outcome|Obese Subjects, Baseline|Baseline studies, obese
1093005|NCT00579813|E2|Reported Event|Obese Subjects|Baseline studies (Oral glucose tolerance test, Dual energy x-ray absorbiometry, Resting metabolic rate, Frequently sampled intravenous glucose tolerance test, biopsies), then 10 weeks treatment on Pioglitazone. Baseline tests are repeated at the end of medication treatment.
1093006|NCT00579813|E1|Reported Event|Lean Subjects|Arm 1 was normal subjects on which baseline studies were performed to determine insulin sensitivity, intramyocellular lipid and resting metabolic rate.
1093007|NCT00579670|B6|Baseline|Total|Total of all reporting groups
1093008|NCT00579670|B5|Baseline|Ziprasidone Unknown|Details are unknown.
1093009|NCT00579670|B4|Baseline|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
1093010|NCT00579670|B3|Baseline|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
1093011|NCT00579670|B2|Baseline|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
1093012|NCT00579670|B1|Baseline|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
1093013|NCT00579670|P5|Participant Flow|Ziprasidone Unknown|Details are unknown.
1093014|NCT00579670|P4|Participant Flow|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
1093015|NCT00579670|P3|Participant Flow|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
1093016|NCT00579670|P2|Participant Flow|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
1093017|NCT00579670|P1|Participant Flow|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
1093018|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
1093019|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
1093020|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
1093021|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
1093022|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
1093023|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
1093024|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
1093025|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
1093026|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
1093027|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
1094501|NCT00577135|O3|Outcome|Low Intensification|
1093028|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
1093029|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
1093030|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
1093031|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
1093032|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
1093033|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
1093034|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
1093035|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
1093036|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
1093037|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
1093038|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
1093039|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
1093040|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
1093041|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
1093042|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
1093043|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
1093044|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
1093045|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
1093046|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
1093047|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
1093048|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
1093049|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
1093050|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
1093051|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
1093052|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
1093053|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
1093054|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
1093055|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
1093056|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
1093057|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
1093058|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
1093059|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
1093060|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
1093061|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
1093062|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
1093065|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
1093066|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
1093067|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
1093068|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
1093069|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
1093070|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
1093071|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
1093072|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
1093073|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
1093074|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
1093075|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
1093076|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
1093077|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
1093078|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
1093079|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
1093080|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
1093081|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
1093082|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
1093083|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
1093084|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
1093085|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
1093086|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
1093087|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
1093088|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
1093089|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
1093090|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
1093091|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
1093092|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
1093093|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
1093094|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
1093095|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
1093096|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
1093097|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
1093098|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
1093099|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
1093100|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
1093101|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
1093102|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
1093103|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
1093104|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
1093105|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
1093106|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
1093107|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
1093108|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
1093109|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
1093110|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
1093111|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
1093112|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
1093113|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
1093114|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
1093115|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
1093116|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
1093117|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
1093118|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
1093119|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
1093120|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
1093121|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
1093122|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
1093123|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
1093124|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
1093125|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
1093128|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
1093129|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
1093130|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
1093131|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
1093132|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
1093133|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
1093134|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
1093135|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
1093136|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
1093137|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
1093138|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
1093139|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
1093140|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
1093141|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
1093142|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
1093143|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
1093144|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
1093145|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
1093146|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
1093147|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
1093148|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
1093149|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
1093150|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
1093151|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
1093152|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
1093153|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
1093154|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
1093155|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
1093156|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
1093157|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
1093158|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
1093159|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
1093160|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
1093161|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
1093162|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
1093163|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
1093164|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
1093165|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
1093166|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
1093167|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
1093168|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
1093169|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
1093170|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
1093171|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
1093172|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
1093173|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
1093174|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
1093175|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
1093176|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
1093177|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
1093178|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
1093179|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
1093180|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
1093181|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
1093182|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
1093183|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
1093184|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
1093185|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
1093186|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
1093187|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
1093188|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
1093189|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
1093190|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
1093191|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
1093192|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
1094456|NCT00577135|O4|Outcome|High Intensification|
1093193|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
1093194|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
1093195|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
1093196|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
1093197|NCT00579670|O5|Outcome|Ziprasodone Unknown|Details are unknown.
1093198|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
1093199|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
1093200|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
1093201|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg per day.
1093202|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
1093203|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
1093204|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
1093205|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
1093206|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
1093207|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
1093208|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
1093209|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
1093210|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
1093211|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
1093212|NCT00579670|O1|Outcome|Ziprasidone Total|Ziprasidone all doses received combined.
1093213|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
1093214|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
1093215|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
1093216|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
1093217|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
1093311|NCT00579098|O2|Outcome|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
1093312|NCT00579098|O1|Outcome|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
1093218|NCT00579670|E10|Reported Event|Above SmPC Ziprasidone > 160 mg|Above SmPC Ziprasidone > 160 mg per day; defined as all participants in FAS population who received at least 1 PO dose above 160 mg per day or any IM dose above 40 mg per day or with an unknown dose or formulation.
1093219|NCT00579670|E9|Reported Event|Within SmPC Ziprasidone = 160 mg|Within SmPC Ziprasidone = 160 mg; defined as all participants in the FAS population who had PO doses = 160 mg per day.
1093220|NCT00579670|E8|Reported Event|Within SmPC Ziprasidone 120 to < 160 mg|Within SmPC Ziprasidone 120 to < 160 mg; defined as all participants in the FAS population who had PO doses between 120 mg and < 160 mg per day.
1093221|NCT00579670|E7|Reported Event|Within SmPC Ziprasidone 80 to < 120 mg|Within SmPC Ziprasidone 80 to < 120 mg; defined as all participants in the FAS population who had PO doses between 80 mg and < 120 mg per day.
1093222|NCT00579670|E6|Reported Event|Within SmPC Ziprasidone < 80 mg|Within SmPC < 80 mg per day; defined as all participants in the FAS population who had PO doses up to 80 mg per day and all IM doses up to and including 40 mg per day.
1093223|NCT00579670|E5|Reported Event|Ziprasidone Unknown|Details are unknown.
1093224|NCT00579670|E4|Reported Event|Ziprasidone >=160 mg|Ziprasidone 160 mg or greater per day.
1093225|NCT00579670|E3|Reported Event|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
1093226|NCT00579670|E2|Reported Event|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
1093227|NCT00579670|E1|Reported Event|Ziprasidone < 80 mg|Ziprasidone up to 80 mg per day.
1093228|NCT00579501|B1|Baseline|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion.
1093229|NCT00579501|P1|Participant Flow|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion.
1093230|NCT00579501|O1|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion.
1093231|NCT00579501|O1|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion.
1093232|NCT00579501|E1|Reported Event|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion.
1093233|NCT00579345|B9|Baseline|Total|Total of all reporting groups
1093234|NCT00579345|B8|Baseline|eTIV_a +PV (Elderly; Concomitant Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
1093295|NCT00579111|P1|Participant Flow|HLA-identical Sibling Transplant|Recipients of HLA identical sibling stem cell transplants
1093235|NCT00579345|B7|Baseline|eTIV_a (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
1093236|NCT00579345|B6|Baseline|cTIV+PV (Elderly; Concomitant Vaccination )|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV; in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
1093237|NCT00579345|B5|Baseline|cTIV (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV]; in the deltoid muscle, preferably of the non-dominant arm) irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study.
1093238|NCT00579345|B4|Baseline|eTIV_a (Elderly)|Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) study with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
1093239|NCT00579345|B3|Baseline|cTIV (Elderly)|Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
1093240|NCT00579345|B2|Baseline|eTIV_a (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies with influenza virus vaccine[egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
1093313|NCT00579098|O2|Outcome|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
1093314|NCT00579098|O1|Outcome|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
1093241|NCT00579345|B1|Baseline|cTIV (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 [NCT00492063]) and the extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
1093242|NCT00579345|P8|Participant Flow|eTIV_a +PV (Elderly; Concomitant Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
1093243|NCT00579345|P7|Participant Flow|eTIV_a (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
1093244|NCT00579345|P6|Participant Flow|cTIV+PV (Elderly; Concomitant Vaccination )|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV; in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
1093245|NCT00579345|P5|Participant Flow|cTIV (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV]; in the deltoid muscle, preferably of the non-dominant arm) irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study.
1093246|NCT00579345|P4|Participant Flow|eTIV_a (Elderly)|Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) study with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
1093247|NCT00579345|P3|Participant Flow|cTIV (Elderly)|Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
1093248|NCT00579345|P2|Participant Flow|eTIV_a (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies with influenza virus vaccine[egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
1093249|NCT00579345|P1|Participant Flow|cTIV (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 [NCT00492063]) and the extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
1093250|NCT00579345|O2|Outcome|FLU (cTIV or eTIV_a)|Elderly subjects (>= 65 years of age) randomized and received only Influenza vaccine (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a).
1093292|NCT00579111|B2|Baseline|Unrelated Matched or Single Antigen Mismatched Transplant|Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants
1093251|NCT00579345|O1|Outcome|FLU (cTIV or eTIV_a) + PV|Elderly subjects (>= 65 years of age) randomized and received influenza vaccine (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) concomitantly with pneumococcal vaccine (PV).
1093252|NCT00579345|O4|Outcome|eTIV_a Total (Elderly)|Revaccination randomized group total (elderly subjects (>= 61 years of age) who received only influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)).
1093253|NCT00579345|O3|Outcome|cTIV Total (Elderly)|Revaccination randomized group total (elderly subjects (>= 61 years of age) who received only (cell-culture derived seasonal trivalent influenza vaccine (cTIV) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)).
1093254|NCT00579345|O2|Outcome|eTIV_a (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies with influenza virus vaccine(egg-derived seasonal trivalent, thiomersal free; eTIV_a) were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
1093255|NCT00579345|O1|Outcome|cTIV (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 [NCT00492063]) and the extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
1093256|NCT00579345|O4|Outcome|eTIV_a Total (Elderly)|Revaccination randomized group total (elderly subjects (>= 61 years of age) who received only influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)).
1093257|NCT00579345|O3|Outcome|cTIV Total (Elderly)|Revaccination randomized group total (elderly subjects (>= 61 years of age) who received only (cell-culture derived seasonal trivalent influenza vaccine (cTIV) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)).
1093258|NCT00579345|O2|Outcome|eTIV_a (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies with influenza virus vaccine(egg-derived seasonal trivalent, thiomersal free; eTIV_a) were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
1093259|NCT00579345|O1|Outcome|cTIV (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 [NCT00492063]) and the extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
1093260|NCT00579345|O2|Outcome|eTIV_a Total (Elderly)|Revaccination randomized group total (elderly subjects (>= 65 years of age) who received only influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)).
1093261|NCT00579345|O1|Outcome|cTIV Total (Elderly)|Revaccination randomized group total (elderly subjects (>= 65 years of age) who received only cell-culture derived seasonal trivalent influenza vaccine (cTIV) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)).
1093262|NCT00579345|O6|Outcome|eTIV_a+PV (Elderly; Concomitant Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) in the deltoid muscle, preferably of the non-dominant arm) and pneumococcal vaccine (PV; in opposite arm) irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study).
1093263|NCT00579345|O5|Outcome|eTIV_a (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study).
1093264|NCT00579345|O4|Outcome|cTIV+PV (Elderly; Concomitant Vaccination )|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with cell-culture derived seasonal trivalent influenza vaccine (cTIV; in the deltoid muscle, preferably of the non-dominant arm) and pneumococcal vaccine (PV; in opposite arm) irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study).
1093265|NCT00579345|O3|Outcome|cTIV (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with cell-culture derived seasonal trivalent influenza vaccine (cTIV; in the deltoid muscle, preferably of the non-dominant arm) irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study.
1093266|NCT00579345|O2|Outcome|FLU (cTIV or eTIV_a)|Elderly subjects (>= 65 years of age) randomized and received only Influenza vaccine (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a)).
1093267|NCT00579345|O1|Outcome|FLU (cTIV or eTIV_a) + PV|Elderly subjects (>= 65 years of age) randomized and received influenza vaccine (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) concomitantly with pneumococcal vaccine (PV)).
1093268|NCT00579345|O4|Outcome|eTIV_a (Elderly)|Revaccination unrandomized group (elderly (>= 61 years of age)subjects who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) study with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
1093293|NCT00579111|B1|Baseline|HLA-identical Sibling Transplant|Recipients of HLA identical sibling stem cell transplants
1093294|NCT00579111|P2|Participant Flow|Unrelated Matched or Single Antigen Mismatched Transplant|Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants
1093269|NCT00579345|O3|Outcome|cTIV (Elderly)|Revaccination unrandomized group (elderly (>= 61 years of age)subjects who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
1093270|NCT00579345|O2|Outcome|eTIV_a (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) studies with influenza virus vaccine(egg-derived seasonal trivalent, thiomersal free; eTIV_a) were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
1093271|NCT00579345|O1|Outcome|cTIV (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4) and the extension 1 (V58P4E1) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
1093272|NCT00579345|E8|Reported Event|eTIV_a +PV (Elderly; Concomitant Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
1093273|NCT00579345|E7|Reported Event|eTIV_a (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age)were revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
1093315|NCT00579098|O2|Outcome|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
1093316|NCT00579098|O1|Outcome|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
1093317|NCT00579098|E2|Reported Event|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
1093274|NCT00579345|E6|Reported Event|cTIV+PV (Elderly; Concomitant Vaccination )|Revaccination randomized group (elderly subjects (>= 65 years of age)were concomitantly revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV; in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
1093275|NCT00579345|E5|Reported Event|cTIV (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV]; in the deltoid muscle, preferably of the non-dominant arm) irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study.
1093276|NCT00579345|E4|Reported Event|eTIV_a (Elderly)|Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) study with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
1093277|NCT00579345|E3|Reported Event|cTIV (Elderly)|Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
1093278|NCT00579345|E2|Reported Event|eTIV_a (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies with influenza virus vaccine[egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
1093279|NCT00579345|E1|Reported Event|cTIV (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 [NCT00492063]) and the extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
1093280|NCT00579254|B1|Baseline|Caduet|Patients were treated with Caduet (5/10 or 5/20 mg) in this study according to prevailing local clinical practice following the locally approved product labeled recommendations.
1093281|NCT00579254|P1|Participant Flow|Caduet|Patients were treated with Caduet (5/10 or 5/20 mg) in this study according to prevailing local clinical practice following the locally approved product labeled recommendations.
1093282|NCT00579254|O1|Outcome|Caduet|Patients were treated with Caduet (5/10 or 5/20 mg) in this study according to prevailing local clinical practice following the locally approved product labeled recommendations.
1093283|NCT00579254|E1|Reported Event|Caduet|Patients were treated with Caduet (5/10 or 5/20 mg) in this study according to prevailing local clinical practice following the locally approved product labeled recommendations.
1093284|NCT00579137|B1|Baseline|Single Group|only one group
1093285|NCT00579137|P1|Participant Flow|Participants With SCID or Primary Immunodeficiency Disorder|"Participants received an allogeneic stem cell transplant with the following conditioning:~Day 8 Campath 1H as per CAGT SOP, Fludarabine 10 kg or less: 1 mg/kg; > 10 kg: 30 mg/m2~D7 Campath 1H as per CAGT SOP, Fludarabine 10 kg or less: 1 mg/kg; > 10 kg: 30 mg/m2~D6 Campath 1H as per CAGT SOP, Fludarabine 10 kg or less: 1 mg/kg; > 10 kg: 30 mg/m2~D5 Anti-CD45 MAb 400ug/kg over 6 hr, Fludarabine 10 kg or less: 1 mg/kg; > 10 kg: 30 mg/m2~D4 Anti-CD45 MAb 400ug/kg over 6 hr, Fludarabine 10 kg or less: 1 mg/kg; > 10 kg: 30 mg/m2~D3 Anti-CD45 MAb 400ug/kg over 6 hr~D2 Anti-CD45 MAb 400ug/kg over 6 hr~D1 rest~D0 Stem Cell Infusion~Campath dose is weight based: for patients less than 15 kg administer Campath 3 mg; for patients >15 kg to 30 kg administer Campath 5 mg; for patients > 30 kg administer Campath 10 mg. Campath will be dosed and administered as per CAGT SOP.~Anti-CD45 infusion will be administered according to CAGT SOPs."
1093286|NCT00579137|O1|Outcome|Single Group|only one group
1093287|NCT00579137|O1|Outcome|Single Group|only one group
1093288|NCT00579137|O1|Outcome|Single Group|only one group
1093289|NCT00579137|O1|Outcome|Single Group|only one group
1093296|NCT00579111|O2|Outcome|Unrelated Matched or Single Antigen Mismatched Transplant|Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants
1093297|NCT00579111|O1|Outcome|HLA-identical Sibling Transplant|Recipients of HLA identical sibling stem cell transplants
1093298|NCT00579111|O2|Outcome|Unrelated Matched or Single Antigen Mismatched Transplant|Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants
1093299|NCT00579111|O1|Outcome|HLA-identical Sibling Transplant|Recipients of HLA identical sibling stem cell transplants
1093300|NCT00579111|E2|Reported Event|Unrelated Matched or Single Antigen Mismatched Transplant|Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants
1093301|NCT00579111|E1|Reported Event|HLA-identical Sibling Transplant|Recipients of HLA identical sibling stem cell transplants
1093302|NCT00579098|B3|Baseline|Total|Total of all reporting groups
1093303|NCT00579098|B2|Baseline|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
1093304|NCT00579098|B1|Baseline|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
1093305|NCT00579098|P2|Participant Flow|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
1093306|NCT00579098|P1|Participant Flow|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
1093307|NCT00579098|O2|Outcome|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
1093308|NCT00579098|O1|Outcome|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
1093309|NCT00579098|O2|Outcome|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
1093310|NCT00579098|O1|Outcome|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
1094502|NCT00577135|O2|Outcome|Continuous Infusion|
1093318|NCT00579098|E1|Reported Event|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
1093319|NCT00579059|B3|Baseline|Total|Total of all reporting groups
1093320|NCT00579059|B2|Baseline|Maxim® Regular Tibia|Tibia with Modular Polyethylene
1093321|NCT00579059|B1|Baseline|Maxim® Pop-Top® Tibia|tibia with removable polyethylene
1093322|NCT00579059|P2|Participant Flow|Maxim® Regular Tibia|Tibia with Modular Polyethylene
1093323|NCT00579059|P1|Participant Flow|Maxim® Pop-Top® Tibia|tibia with removable polyethylene
1093324|NCT00579059|O2|Outcome|Maxim® Regular Tibia|Tibia with Modular Polyethylene
1093325|NCT00579059|O1|Outcome|Maxim® Pop-Top® Tibia|tibia with removable polyethylene
1093326|NCT00579059|O2|Outcome|Maxim® Regular Tibia|Tibia with Modular Polyethylene
1093327|NCT00579059|O1|Outcome|Maxim® Pop-Top® Tibia|tibia with removable polyethylene
1093328|NCT00579059|E2|Reported Event|Maxim® Regular Tibia|Tibia with Modular Polyethylene
1093329|NCT00579059|E1|Reported Event|Maxim® Pop-Top® Tibia|tibia with removable polyethylene
1093330|NCT00578968|B4|Baseline|Total|Total of all reporting groups
1093331|NCT00578968|B3|Baseline|Healthy Controls|Healthy age and gender matched controls were recruited for comparing cardiovascular responses to participants with chronic obstructive pulmonary disease prior to the intervention.
1093332|NCT00578968|B2|Baseline|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
1093333|NCT00578968|B1|Baseline|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
1093334|NCT00578968|P3|Participant Flow|Healthy Controls|Healthy age and gender matched controls were recruited for comparing cardiovascular responses to participants with chronic obstructive pulmonary disease prior to the intervention.
1093335|NCT00578968|P2|Participant Flow|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
1093336|NCT00578968|P1|Participant Flow|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
1093337|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
1093338|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
1093339|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
1093340|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
1093341|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
1093342|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
1093343|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
1093344|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
1093345|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
1093346|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
1093347|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
1093348|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
1093349|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
1093350|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
1093351|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
1093352|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
1093353|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
1093354|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
1093355|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
1093356|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
1093357|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
1093414|NCT00578929|O1|Outcome|Olopatadine 0.6% 1 Spray|Olopatadine HCl 0.6% 1 spray per nostril twice daily
1093358|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
1093359|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
1093360|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
1093361|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
1093362|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
1093363|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
1093364|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
1093365|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
1093366|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
1093367|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
1093368|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
1093369|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
1093370|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
1093371|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
1093372|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
1093373|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
1093374|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
1093375|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
1093376|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
1093377|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
1093378|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
1093379|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
1093380|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
1093381|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
1093382|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
1093383|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
1093384|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
1093385|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
1093386|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
1093387|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
1093388|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
1093389|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
1093415|NCT00578929|O4|Outcome|Vehicle 2 Sprays|Vehicle 2 sprays per nostril twice daily
1093390|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
1093391|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
1093392|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
1093393|NCT00578968|E3|Reported Event|Healthy Controls|Healthy age and gender matched controls were recruited for comparing cardiovascular responses to participants with chronic obstructive pulmonary disease prior to the intervention.
1093394|NCT00578968|E2|Reported Event|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
1093395|NCT00578968|E1|Reported Event|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
1093396|NCT00578942|B1|Baseline|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Patient Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45."
1093397|NCT00578942|P1|Participant Flow|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45."
1093398|NCT00578942|O1|Outcome|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily (dose will be rounded to the nearest whole vial size), Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45."
1093399|NCT00578942|O1|Outcome|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily (dose will be rounded to the nearest whole vial size), Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45."
1093577|NCT00578734|P1|Participant Flow|Lucinactant|KL₄Surfactant (lucinactant) endotracheal instillation
1093400|NCT00578942|O1|Outcome|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily (dose will be rounded to the nearest whole vial size), Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45."
1093401|NCT00578942|E1|Reported Event|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45."
1093402|NCT00578929|B5|Baseline|Total|Total of all reporting groups
1093403|NCT00578929|B4|Baseline|Vehicle 2 Sprays|Vehicle 2 sprays per nostril twice daily
1093404|NCT00578929|B3|Baseline|Olopatadine 0.6% 2 Sprays|Olopatadine HCl 0.6% 2 Sprays per nostril twice daily
1093405|NCT00578929|B2|Baseline|Vehicle 1 Spray|Vehicle 1 spray per nostril twice daily
1093406|NCT00578929|B1|Baseline|Olopatadine 0.6% 1 Spray|Olopatadine HCl 0.6% 1 spray per nostril twice daily
1093407|NCT00578929|P4|Participant Flow|Vehicle 2 Sprays|Vehicle 2 sprays per nostril twice daily
1093408|NCT00578929|P3|Participant Flow|Olopatadine 0.6% 2 Sprays|Olopatadine HCl 0.6% 2 Sprays per nostril twice daily
1093409|NCT00578929|P2|Participant Flow|Vehicle 1 Spray|Vehicle 1 spray per nostril twice daily
1093410|NCT00578929|P1|Participant Flow|Olopatadine 0.6% 1 Spray|Olopatadine HCl 0.6% 1 spray per nostril twice daily
1093411|NCT00578929|O4|Outcome|Vehicle 2 Sprays|Vehicle 2 sprays per nostril twice daily
1093412|NCT00578929|O3|Outcome|Olopatadine 0.6% 2 Sprays|Olopatadine HCl 0.6% 2 Sprays per nostril twice daily
1093413|NCT00578929|O2|Outcome|Vehicle 1 Spray|Vehicle 1 spray per nostril twice daily
1093416|NCT00578929|O3|Outcome|Olopatadine 0.6% 2 Sprays|Olopatadine HCl 0.6% 2 Sprays per nostril twice daily
1093417|NCT00578929|O2|Outcome|Vehicle 1 Spray|Vehicle 1 spray per nostril twice daily
1093418|NCT00578929|O1|Outcome|Olopatadine 0.6% 1 Spray|Olopatadine HCl 0.6% 1 spray per nostril twice daily
1093419|NCT00578929|E5|Reported Event|Vehicle Run-in Period|Vehicle Run-in Period
1093420|NCT00578929|E4|Reported Event|Vehicle 2 Sprays|Vehicle 2 sprays per nostril twice daily
1093421|NCT00578929|E3|Reported Event|Olopatadine 0.6% 2 Sprays|Olopatadine HCl 0.6% 2 Sprays per nostril twice daily
1093422|NCT00578929|E2|Reported Event|Vehicle 1 Spray|Vehicle 1 spray per nostril twice daily
1093423|NCT00578929|E1|Reported Event|Olopatadine 0.6% 1 Spray|Olopatadine HCl 0.6% 1 spray per nostril twice daily
1093424|NCT00578903|B1|Baseline|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
1093425|NCT00578903|P1|Participant Flow|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
1093426|NCT00578903|O1|Outcome|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
1093427|NCT00578903|O1|Outcome|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
1093428|NCT00578903|O1|Outcome|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
1093429|NCT00578903|O1|Outcome|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
1093430|NCT00578903|O1|Outcome|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
1093431|NCT00578903|O1|Outcome|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
1093432|NCT00578903|E1|Reported Event|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
1093433|NCT00578864|B3|Baseline|Total|Total of all reporting groups
1093434|NCT00578864|B2|Baseline|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
1093435|NCT00578864|B1|Baseline|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
1093436|NCT00578864|P2|Participant Flow|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
1093437|NCT00578864|P1|Participant Flow|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
1093438|NCT00578864|O2|Outcome|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
1093439|NCT00578864|O1|Outcome|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
1093440|NCT00578864|O2|Outcome|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
1093441|NCT00578864|O1|Outcome|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
1093442|NCT00578864|O2|Outcome|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
1093443|NCT00578864|O1|Outcome|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
1093444|NCT00578864|O2|Outcome|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
1093445|NCT00578864|O1|Outcome|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
1093446|NCT00578864|O2|Outcome|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
1093447|NCT00578864|O1|Outcome|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
1093448|NCT00578864|E2|Reported Event|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
1093449|NCT00578864|E1|Reported Event|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
1093450|NCT00578812|B3|Baseline|Total|Total of all reporting groups
1093451|NCT00578812|B2|Baseline|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093452|NCT00578812|B1|Baseline|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093453|NCT00578812|P2|Participant Flow|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093454|NCT00578812|P1|Participant Flow|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093455|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093916|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
1093456|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093457|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093458|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093459|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093460|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093461|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093462|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093463|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093464|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093465|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093466|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093467|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093468|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093469|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093470|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093471|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093472|NCT00578812|O1|Outcome|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093473|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093474|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093475|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093476|NCT00578812|O1|Outcome|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093477|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093478|NCT00578812|O1|Outcome|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093479|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093480|NCT00578812|O1|Outcome|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093481|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093482|NCT00578812|O1|Outcome|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093483|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093484|NCT00578812|O1|Outcome|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093485|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093486|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1094503|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
1093487|NCT00578812|E2|Reported Event|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093488|NCT00578812|E1|Reported Event|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
1093489|NCT00578786|B4|Baseline|Total|Total of all reporting groups
1093490|NCT00578786|B3|Baseline|Ambrisentan 10 mg|Original randomized dose group in the prior study (NCT00423748 and NCT00423202) or in the current study (for subjects originally randomized to placebo in one of the prior studies).
1093491|NCT00578786|B2|Baseline|Ambrisentan 5 mg|Original randomized dose group in the prior study (NCT00423748 and NCT00423202) or in the current study (for subjects originally randomized to placebo in one of the prior studies). Analysis included those not enrolling in this study but received AMB in 1 of the 2 parent studies. It should be noted that by Year 3, a third starting at 5 mg were titrated to 10 mg.
1093492|NCT00578786|B1|Baseline|Ambrisentan 2.5 mg|Original randomized dose group in the prior study (NCT00423748 and NCT00423202) or in the current study (for subjects originally randomized to placebo in one of the prior studies). Analysis included those not enrolling in this study but received AMB in 1 of the 2 parent studies. It should be noted that by Year 3, almost half of those randomized to AMB 2.5 mg were titrated to 5 mg and 10 mg.
1093493|NCT00578786|P3|Participant Flow|Ambrisentan 10 mg|Original randomized dose group in the prior study (NCT00423748 and NCT00423202) or in the current study (for subjects originally randomized to placebo in one of the prior studies).
1093494|NCT00578786|P2|Participant Flow|Ambrisentan 5 mg|Original randomized dose group in the prior study (NCT00423748 and NCT00423202) or in the current study (for subjects originally randomized to placebo in one of the prior studies). Analysis included those not enrolling in this study but received AMB in 1 of the 2 parent studies. It should be noted that by Year 3, a third starting at 5 mg were titrated to 10 mg.
1093495|NCT00578786|P1|Participant Flow|Ambrisentan 2.5 mg|Original randomized dose group in the prior study (NCT00423748 and NCT00423202) or in the current study (for subjects originally randomized to placebo in one of the prior studies). Analysis included those not enrolling in this study but received AMB in 1 of the 2 parent studies. It should be noted that by Year 3, almost half of those randomized to AMB 2.5 mg were titrated to 5 mg and 10 mg.
1093496|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on the highest dose of AMB received at any time during the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093497|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on the highest dose of AMB received at any time during the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093498|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on the highest dose of AMB received at any time during the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093499|NCT00578786|O4|Outcome|Ambrisentan Combined Group|All dose groups combined.
1093500|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093501|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093502|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093503|NCT00578786|O4|Outcome|Ambrisentan Combined Group|All dose groups combined.
1093578|NCT00578734|O2|Outcome|Sham Air|Sham air (placebo) instillation
1093504|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093505|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093506|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093507|NCT00578786|O4|Outcome|Ambrisentan Combined Group|All dose groups combined.
1093508|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093509|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093510|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093511|NCT00578786|O1|Outcome|Combined Ambrisentan Group|All dose groups combined.
1093512|NCT00578786|O1|Outcome|Combined Ambrisentan Group|(All Doses)
1093513|NCT00578786|O1|Outcome|Combined Ambrisentan Group|All dose groups combined.
1093514|NCT00578786|O1|Outcome|Combined Ambrisentan Group|All dose groups combined.
1093515|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
1093516|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093517|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093518|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093519|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
1093520|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093521|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093522|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093523|NCT00578786|O4|Outcome|Ambrisentan Combined Group|All dose groups combined.
1093524|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093525|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093526|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093527|NCT00578786|O4|Outcome|Ambrisentan Combined Group|All dose groups combined.
1093528|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093529|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093530|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093531|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
1093532|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093533|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093534|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093535|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
1093536|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093537|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093538|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093539|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
1093540|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093579|NCT00578734|O1|Outcome|Lucinactant|KL₄Surfactant (lucinactant) endotracheal instillation
1093541|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093542|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093543|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
1093544|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093545|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093546|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093547|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
1093548|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093549|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093550|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093551|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
1093552|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093553|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093917|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
1093554|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093555|NCT00578786|O4|Outcome|Ambrisentan Combined Group|All dose groups combined.
1093556|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093557|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093558|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093559|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
1093560|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of ambrisentan in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093561|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of ambrisentan in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093562|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of ambrisentan in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093563|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093564|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093565|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093566|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
1093567|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093568|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093569|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093570|NCT00578786|E3|Reported Event|Ambrisentan 10 mg|Participants were classified based on the highest dose of ambrisentan received at any time during the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093571|NCT00578786|E2|Reported Event|Ambrisentan 5 mg|Participants were classified based on the highest dose of ambrisentan received at any time during the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093572|NCT00578786|E1|Reported Event|Ambrisentan 2.5 mg|Participants were classified based on the highest dose of ambrisentan received at any time during the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
1093573|NCT00578734|B3|Baseline|Total|Total of all reporting groups
1093574|NCT00578734|B2|Baseline|Sham Air|Sham air (placebo) instillation
1093575|NCT00578734|B1|Baseline|Lucinactant|KL₄Surfactant (lucinactant) endotracheal instillation
1093576|NCT00578734|P2|Participant Flow|Sham Air|Sham air (placebo) instillation
1093581|NCT00578734|O1|Outcome|Lucinactant|KL₄Surfactant (lucinactant) endotracheal instillation
1093582|NCT00578734|E2|Reported Event|Sham Air|Sham air (placebo) instillation
1093583|NCT00578734|E1|Reported Event|Lucinactant|KL₄Surfactant (lucinactant) endotracheal instillation
1093584|NCT00578617|B3|Baseline|Total|Total of all reporting groups
1093585|NCT00578617|B2|Baseline|Ablation Therapy|Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.
1093586|NCT00578617|B1|Baseline|Drug Therapy|Pharmacologic Therapy Rate and/or Rhythm Control: MD to choose from this list as medically indicated, doses are min recommended daily dose: metoprolol 50-100 mg, atenolol 50-100 mg, propanolol 40-80 mg, acebutolol 200 mg, carvedilol 6.25 mg, diltiazem 180-240 mg, verapamil 180-240 mg, digoxin 0.125 mg, propafenone 450 mg, flecainide 200 mg, sotalol 240 mg, dofetilide 500 mcg, amiodarone 200 mg, quinidine 600-900 mcg.
1093587|NCT00578617|P2|Participant Flow|Ablation Therapy|Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.
1093588|NCT00578617|P1|Participant Flow|Drug Therapy|Pharmacologic Therapy Rate and/or Rhythm Control: MD to choose from this list as medically indicated, doses are min recommended daily dose: metoprolol 50-100 mg, atenolol 50-100 mg, propanolol 40-80 mg, acebutolol 200 mg, carvedilol 6.25 mg, diltiazem 180-240 mg, verapamil 180-240 mg, digoxin 0.125 mg, propafenone 450 mg, flecainide 200 mg, sotalol 240 mg, dofetilide 500 mcg, amiodarone 200 mg, quinidine 600-900 mcg.
1093589|NCT00578617|O2|Outcome|Ablation Therapy|Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.
1093660|NCT00577642|B1|Baseline|Zoledronic Acid|Single dose Zoledronic Acid (Zoledronate) 4mg IV over at least 15 minutes (or dose corrected for creatinine clearance x1) followed by Aminobisphosphonates (aBP) cessation during study period
1093590|NCT00578617|O1|Outcome|Drug Therapy|Pharmacologic Therapy Rate and/or Rhythm Control: MD to choose from this list as medically indicated, doses are min recommended daily dose: metoprolol 50-100 mg, atenolol 50-100 mg, propanolol 40-80 mg, acebutolol 200 mg, carvedilol 6.25 mg, diltiazem 180-240 mg, verapamil 180-240 mg, digoxin 0.125 mg, propafenone 450 mg, flecainide 200 mg, sotalol 240 mg, dofetilide 500 mcg, amiodarone 200 mg, quinidine 600-900 mcg.
1093591|NCT00578617|E2|Reported Event|Ablation Therapy|Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.
1093592|NCT00578617|E1|Reported Event|Drug Therapy|Pharmacologic Therapy Rate and/or Rhythm Control: MD to choose from this list as medically indicated, doses are min recommended daily dose: metoprolol 50-100 mg, atenolol 50-100 mg, propanolol 40-80 mg, acebutolol 200 mg, carvedilol 6.25 mg, diltiazem 180-240 mg, verapamil 180-240 mg, digoxin 0.125 mg, propafenone 450 mg, flecainide 200 mg, sotalol 240 mg, dofetilide 500 mcg, amiodarone 200 mg, quinidine 600-900 mcg.
1093593|NCT00578565|B1|Baseline|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months
1093594|NCT00578565|P1|Participant Flow|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months
1093595|NCT00578565|O1|Outcome|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V. on each days 1 and 15 with repeat dosing at 6 months
1093596|NCT00578565|O1|Outcome|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months
1093597|NCT00578565|O1|Outcome|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months
1093598|NCT00578565|O1|Outcome|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months
1093599|NCT00578565|O1|Outcome|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V. on each days 1 and 15 with repeat dosing at 6 months
1093600|NCT00578565|O1|Outcome|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months
1093601|NCT00578565|E1|Reported Event|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months
1093602|NCT00578552|B4|Baseline|Total|Total of all reporting groups
1093603|NCT00578552|B3|Baseline|Gabapentin - 2700 mg/Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 900 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
1093604|NCT00578552|B2|Baseline|Gabapentin - 1800 mg /Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 600 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
1093605|NCT00578552|B1|Baseline|Placebo|Placebo pill was identical in appearance to the active medication. Initial dosage consisted of 1 pill by mouth in the morning and night. The dose was increased over the first 2 weeks to the target frequency of three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
1093606|NCT00578552|P3|Participant Flow|Gabapentin - 2700 mg/Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 900 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
1093607|NCT00578552|P2|Participant Flow|Gabapentin - 1800 mg /Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 600 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
1093642|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
1093643|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
1093608|NCT00578552|P1|Participant Flow|Placebo|Placebo pill was identical in appearance to the active medication. Initial dosage consisted of 1 pill by mouth in the morning and night. The dose was increased over the first 2 weeks to the target frequency of three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
1093609|NCT00578552|O3|Outcome|Gabapentin - 2700 mg/Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 900 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
1093610|NCT00578552|O2|Outcome|Gabapentin - 1800 mg /Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 600 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
1093611|NCT00578552|O1|Outcome|Placebo|Placebo pill was identical in appearance to the active medication. Initial dosage consisted of 1 pill by mouth in the morning and night. The dose was increased over the first 2 weeks to the target frequency of three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
1093612|NCT00578552|E3|Reported Event|Gabapentin - 2700 mg/Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 900 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
1093613|NCT00578552|E2|Reported Event|Gabapentin - 1800 mg /Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 600 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
1093661|NCT00577642|P1|Participant Flow|Zoledronic Acid|Single dose Zoledronic Acid (Zoledronate) 4mg IV over at least 15 minutes (or dose corrected for creatinine clearance x1) followed by Aminobisphosphonates (aBP) cessation during study period.
1093614|NCT00578552|E1|Reported Event|Placebo|Placebo pill was identical in appearance to the active medication. Initial dosage consisted of 1 pill by mouth in the morning and night. The dose was increased over the first 2 weeks to the target frequency of three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
1093615|NCT00578539|B1|Baseline|Stem Cell Transplant|All patients will receive stem cell transplantation conditioning, GVHD prevention and stem cell infusion.
1093616|NCT00578539|P1|Participant Flow|Stem Cell Transplant|All patients will receive Ara C IV every 12 hours for 6 doses starting at 1400 hours on day -8. Cyclophosphamide IV once daily on day -7 and day -6 starting at 1400 hours. MESNA will be administered 15 minutes prior to each dose of Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide. Campath 1h will be given on day -4, day -3, day -2 and day-1. TBI (Total Body Irradiation) will be delivered in 8 fractions of 1.75 Gy in two fractions on day -4, day -3, day -2, and day -1. Stem cell Infusion are infused on day 0.
1093617|NCT00578539|O1|Outcome|Stem Cell Transplant|All patients will receive Ara C IV every 12 hours for 6 doses starting at 1400 hours on day -8. Cyclophosphamide IV once daily on day -7 and day -6 starting at 1400 hours. MESNA will be administered 15 minutes prior to each dose of Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide. Campath 1h will be given on day -4, day -3, day -2 and day-1. TBI (Total Body Irradiation) will be delivered in 8 fractions of 1.75 Gy in two fractions on day -4, day -3, day -2, and day -1. Stem cell Infusion are infused on day 0.
1093618|NCT00578539|E1|Reported Event|Stem Cell Transplant|All patients will receive Ara C IV every 12 hours for 6 doses starting at 1400 hours on day -8. Cyclophosphamide IV once daily on day -7 and day -6 starting at 1400 hours. MESNA will be administered 15 minutes prior to each dose of Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide. Campath 1h will be given on day -4, day -3, day -2 and day-1. TBI (Total Body Irradiation) will be delivered in 8 fractions of 1.75 Gy in two fractions on day -4, day -3, day -2, and day -1. Stem cell Infusion are infused on day 0.
1093619|NCT00577655|B3|Baseline|Total|Total of all reporting groups
1093620|NCT00577655|B2|Baseline|Placebo|Placebo HFA-MDI four times a day for 21 days.
1093621|NCT00577655|B1|Baseline|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
1093622|NCT00577655|P2|Participant Flow|Placebo|Placebo HFA-MDI four times a day for 21 days.
1093623|NCT00577655|P1|Participant Flow|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
1093624|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
1093625|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
1093626|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
1093627|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
1093628|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
1093629|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
1093630|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
1093631|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
1093632|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
1093633|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
1093634|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
1093635|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
1093636|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
1093637|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
1093638|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
1093639|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
1093640|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
1093641|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
1093644|NCT00577655|O2|Outcome|Placebo|Placebo-HFA-MDI four times a day for 21 days.
1093645|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
1093646|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
1093647|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
1093648|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
1093649|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
1093650|NCT00577655|O2|Outcome|Placebo|Placebo-HFA-MDI four times a day for 21 days.
1093651|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
1093652|NCT00577655|O2|Outcome|Placebo|Placebo-HFA-MDI four times a day for 21 days.
1093653|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
1093654|NCT00577655|O2|Outcome|Placebo|Placebo-HFA-MDI four times a day for 21 days.
1093655|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
1093656|NCT00577655|O2|Outcome|Placebo|Placebo-HFA-MDI four times a day for 21 days.
1093657|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
1093658|NCT00577655|E2|Reported Event|Placebo|Placebo HFA-MDI four times a day for 21 days.
1093659|NCT00577655|E1|Reported Event|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day
1093856|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
1093662|NCT00577642|O1|Outcome|Zoledronic Acid|Single dose Zoledronic Acid (Zoledronate) 4mg IV over at least 15 minutes (or dose corrected for creatinine clearance x1) followed by Aminobisphosphonates (aBP) treatment cessation during study period.
1093663|NCT00577642|E1|Reported Event|Single Arm Study|This was a nonintervention biomarker study after a single dose of Zoledronic acid.
1093664|NCT00577629|B1|Baseline|All Subjects|Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy:Bexxar
1093665|NCT00577629|P1|Participant Flow|All Subjects|Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy:Bexxar
1093666|NCT00577629|O1|Outcome|Experimental: Induction + Consolidation + Bexxar|Induction: Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation: Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar
1093667|NCT00577629|O1|Outcome|Experimental: Induction + Consolidation + Bexxar|Induction: Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation: Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar)
1093668|NCT00577629|O1|Outcome|Experimental: Induction + Consolidation + Bexxar|Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar
1093669|NCT00577629|O1|Outcome|Experimental: Induction + Consolidation + Bexxar|Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar
1093670|NCT00577629|O1|Outcome|Experimental: Induction + Consolidation + Bexxar|Induction: Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation: Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar
1093671|NCT00577629|E1|Reported Event|Experimental: Induction + Consolidation + Bexxar|Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar
1093672|NCT00578461|B1|Baseline|Stem Cell Transplant|All patients will receive stem cell transplantation conditioning, GVHD prevention and stem cell infusion.
1093673|NCT00578461|P1|Participant Flow|Stem Cell Transplant|"All patients will receive stem cell transplantation conditioning, GVHD prevention and stem cell infusion.~Conditioning includes: Ara C, Cyclophosphamide, MESNA, TBI-Total Body Irradiation. Ara C: 3000 mg/m^2 - pts will receive via IV every 12 hours for 6 doses starting at 20:00 hours on day -8.Mesna: 45 mg/kg; divided into 5 doses-will be administered 15 minutes prior to Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide.~Cyclophosphamide: 45 mg/kg; IV once daily on day -7 and day -6 starting at 1400 hours.TBI-Total Body Irradiation: Total dose 12 Gy, will be delivered in 8 fractions of 150 cGy, each, two fractions per day beginning day -4 to day -1. Stem cell Infusion is on day 0."
1093674|NCT00578461|O1|Outcome|Stem Cell Transplant|All patients will be receiving a stem cell transplant on study. Conditioning includes: Ara C, Cyclophosphamide, MESNA, TBI-Total Body Irradiation.
1093675|NCT00578461|E1|Reported Event|Stem Cell Transplant|"All patients will receive stem cell transplantation conditioning, GVHD prevention and stem cell infusion.~Conditioning includes: Ara C, Cyclophosphamide, MESNA, TBI-Total Body Irradiation. Ara C: 3000 mg/m^2 - pts will receive via IV every 12 hours for 6 doses starting at 20:00 hours on day -8.Mesna: 45 mg/kg; divided into 5 doses-will be administered 15 minutes prior to Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide. Cyclophosphamide: 45 mg/kg; IV once daily on day -7 and day -6 starting at 1400 hours.TBI-Total Body Irradiation: Total dose 12 Gy, will be delivered in 8 fractions of 150 cGy, each, two fractions per day beginning day -4 to day -1. Stem cell Infusion is on day 0."
1093676|NCT00578448|B1|Baseline|IV Belatacept 10mg/kg With 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 4 (Weeks 8 and 12). After 4 months, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the trial.
1093699|NCT00578383|O2|Outcome|Major Depressive Disorder Sham LFMS Treatment|Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active
1094156|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
1093677|NCT00578448|P1|Participant Flow|Belatacept 10mg/kg; 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 4 (Weeks 8 and 12). After 4 months, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the trial (3 years and then a 1 year extension was available for those who completed the 3rd year).
1093678|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
1093679|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
1093680|NCT00578448|O1|Outcome|Belatacept 10mg/kg; 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study (3 years planned study; 1 year extension allowed to those who completed 3rd year).
1093681|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
1093857|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
1093858|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
1093682|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
1093683|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
1093684|NCT00578448|O1|Outcome|10mg/kg IV Belatacept|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
1093685|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
1093686|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
1093687|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
1093688|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
1093689|NCT00578448|E1|Reported Event|Bela 10-5mg/kg|
1093690|NCT00578383|B5|Baseline|Total|Total of all reporting groups
1093691|NCT00578383|B4|Baseline|Major Depressive Disorder Sham LFMS Treatment|Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
1093692|NCT00578383|B3|Baseline|Major Depressive Disorder Active LFMS Treatment|Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
1093693|NCT00578383|B2|Baseline|Bipolar Disorder Sham LFMS Treatment|Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
1093694|NCT00578383|B1|Baseline|Bipolar Disorder Active LFMS Treatment|Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
1093695|NCT00578383|P4|Participant Flow|Major Depressive Disorder Sham LFMS Treatment|Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
1093696|NCT00578383|P3|Participant Flow|Major Depressive Disorder Active LFMS Treatment|Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
1093697|NCT00578383|P2|Participant Flow|Bipolar Disorder Sham LFMS Treatment|Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
1093698|NCT00578383|P1|Participant Flow|Bipolar Disorder Active LFMS Treatment|Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
1093700|NCT00578383|O1|Outcome|Major Depressive Disorder Active LFMS Treatment|Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
1093701|NCT00578383|O2|Outcome|Bipolar Disorder Sham LFMS Treatment|Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
1093702|NCT00578383|O1|Outcome|Bipolar Disorder Active LFMS Treatment|Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
1093703|NCT00578383|O2|Outcome|Major Depressive Disorder Sham LFMS Treatment|Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active
1093704|NCT00578383|O1|Outcome|Major Depressive Disorder Active LFMS Treatment|Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
1093705|NCT00578383|O2|Outcome|Bipolar Disorder Sham LFMS Treatment|Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
1093706|NCT00578383|O1|Outcome|Bipolar Disorder Active LFMS Treatment|Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
1093707|NCT00578383|O2|Outcome|Major Depressive Disorder Sham LFMS Treatment|Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active
1093708|NCT00578383|O1|Outcome|Major Depressive Disorder Active LFMS Treatment|Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
1093918|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
1093709|NCT00578383|O2|Outcome|Bipolar Disorder Sham LFMS Treatment|Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
1093710|NCT00578383|O1|Outcome|Bipolar Disorder Active LFMS Treatment|Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
1093711|NCT00578383|O2|Outcome|Major Depressive Disorder Sham LFMS Treatment|Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active
1093712|NCT00578383|O1|Outcome|Major Depressive Disorder Active LFMS Treatment|Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
1093713|NCT00578383|O2|Outcome|Bipolar Disorder Sham LFMS Treatment|Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
1093714|NCT00578383|O1|Outcome|Bipolar Disorder Active LFMS Treatment|Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
1093715|NCT00578383|O2|Outcome|Combined Groups Sham LFMS Treatment|Combined diagnostic groups receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
1093716|NCT00578383|O1|Outcome|Combined Groups Active LFMS Treatment|Combined diagnostic groups receiving active treatment with the Low Field Magnetic Stimulation Device.
1093717|NCT00578383|O2|Outcome|Combined Groups Sham LFMS Treatment|Combined diagnostic groups receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
1093718|NCT00578383|O1|Outcome|Combined Groups Active LFMS Treatment|Combined diagnostic groups receiving active treatment with the Low Field Magnetic Stimulation Device.
1093719|NCT00578383|O2|Outcome|Combined Groups Sham LFMS Treatment|Combined diagnostic groups receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
1093720|NCT00578383|O1|Outcome|Combined Group Active LFMS Treatment|Combined diagnostic groups receiving active treatment with the Low Field Magnetic Stimulation Device.
1093721|NCT00578383|O2|Outcome|Combined Group Sham LFMS Treatment|Combined diagnostic groups receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
1093722|NCT00578383|O1|Outcome|Combined Group Active LFMS Treatment|Combined diagnostic groups receiving active treatment with the Low Field Magnetic Stimulation Device.
1093723|NCT00578383|E4|Reported Event|Major Depressive Disorder Sham LFMS Treatment|Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
1093724|NCT00578383|E3|Reported Event|Major Depressive Disorder Active LFMS Treatment|Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
1093725|NCT00578383|E2|Reported Event|Bipolar Disorder Sham LFMS Treatment|Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
1093726|NCT00578383|E1|Reported Event|Bipolar Disorder Active LFMS Treatment|Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
1093727|NCT00578331|B3|Baseline|Total|Total of all reporting groups
1093728|NCT00578331|B2|Baseline|Olopatadine 0.6% Nasal Spray|
1093729|NCT00578331|B1|Baseline|Placebo Nasal Spray|
1093730|NCT00578331|P2|Participant Flow|Olopatadine 0.6% Nasal Spray|2 sprays each nostril twice daily
1093731|NCT00578331|P1|Participant Flow|Placebo Nasal Spray|2 sprays each nostril twice daily
1093732|NCT00578331|O2|Outcome|Olopatadine 0.6% Nasal Spray|
1093733|NCT00578331|O1|Outcome|Placebo Nasal Spray|
1093734|NCT00578331|O2|Outcome|Olopatadine 0.6% Nasal Spray|
1093735|NCT00578331|O1|Outcome|Placebo Nasal Spray|
1093736|NCT00578331|E2|Reported Event|Olopatadine 0.6% Nasal Spray|
1093739|NCT00578318|B2|Baseline|Delayed Control|At the conclusion of enrollment of all active patients, delayed control patients were offered opportunity to receive culturally relevant Motivational Interviewing intervention.
1093740|NCT00578318|B1|Baseline|Motivational Interviewing Active|2 sessions with parent/legal guardian and adolescent study patient of culturally relevant Motivational Interviewing intervention
1093741|NCT00578318|P2|Participant Flow|Delayed Control|At the conclusion of enrollment of all active patients, delayed control patients were offered opportunity to receive culturally relevant Motivational Interviewing intervention.
1093742|NCT00578318|P1|Participant Flow|Motivational Interviewing Active|2 sessions with parent/legal guardian and adolescent study patient of culturally relevant Motivational Interviewing intervention
1093743|NCT00578318|O2|Outcome|Delayed Control|At the conclusion of enrollment of all active patients, delayed control patients were offered opportunity to receive culturally relevant Motivational Interviewing intervention.
1093744|NCT00578318|O1|Outcome|Motivational Interviewing Active|2 sessions with parent/legal guardian and adolescent study patient of culturally relevant Motivational Interviewing intervention
1093745|NCT00578318|E2|Reported Event|Delayed Control|At the conclusion of enrollment of all active patients, delayed control patients were offered opportunity to receive culturally relevant Motivational Interviewing intervention.
1093746|NCT00578318|E1|Reported Event|Motivational Interviewing Active|2 sessions with parent/legal guardian and adolescent study patient of culturally relevant Motivational Interviewing intervention
1093747|NCT00578305|B4|Baseline|Total|Total of all reporting groups
1093859|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
1094504|NCT00577135|O4|Outcome|High Intensification|
1093748|NCT00578305|B3|Baseline|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093749|NCT00578305|B2|Baseline|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093750|NCT00578305|B1|Baseline|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093751|NCT00578305|P3|Participant Flow|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093752|NCT00578305|P2|Participant Flow|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093753|NCT00578305|P1|Participant Flow|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093754|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093755|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093756|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093757|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093860|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
1093861|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
1093919|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
1094505|NCT00577135|O3|Outcome|Low Intensification|
1093758|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093759|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093760|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093761|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093762|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093763|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093764|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093765|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093837|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
1093838|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
1093839|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
1093766|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093767|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093768|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093769|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093770|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093771|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093772|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093773|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093774|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093775|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093840|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
1093841|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
1093842|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
1093776|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093777|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093778|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093779|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093780|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093781|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093782|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093783|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093784|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093785|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093843|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
1093844|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
1093845|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
1093786|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093787|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093788|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093789|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093790|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093791|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093792|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093793|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093794|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093795|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093846|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
1093847|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
1093848|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
1093796|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093797|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093798|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093799|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093800|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093801|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093802|NCT00578305|E9|Reported Event|Placebo - Safety Follow-up Phase|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093803|NCT00578305|E8|Reported Event|Rituximab 1000 mg - Safety Follow-up Phase|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093804|NCT00578305|E7|Reported Event|Rituximab 500 mg - Safety Follow-up Phase|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093805|NCT00578305|E6|Reported Event|Placebo - Extension Phase|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093849|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
1093850|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
1093806|NCT00578305|E5|Reported Event|Rituximab 1000 mg - Extension Phase|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093862|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
1093863|NCT00578227|O4|Outcome|9-Year Old Cervarix Vaccine Recipients|All 9-year subjects who received 3 doses of HPV vaccine alone or co-administered with HAB vaccine.
1093864|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
1093865|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
1093807|NCT00578305|E4|Reported Event|Rituximab 500 mg - Extension Phase|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093808|NCT00578305|E3|Reported Event|Placebo - Double-blind Treatment Phase|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093809|NCT00578305|E2|Reported Event|Rituximab 1000 mg - Double-blind Treatment Phase|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093810|NCT00578305|E1|Reported Event|Rituximab 500 mg - Double-blind Treatment Phase|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
1093811|NCT00578279|B3|Baseline|Total|Total of all reporting groups
1093812|NCT00578279|B2|Baseline|20 mL of Alcohol Injection|subject randomized to 20ml of dehydrated alcohol
1093813|NCT00578279|B1|Baseline|10 mL of Alcohol Injection|subject randomized to 10ml of dehydrated alcohol
1093814|NCT00578279|P2|Participant Flow|20 mL of Alcohol Injection|subject randomized to 20ml of dehydrated alcohol
1093815|NCT00578279|P1|Participant Flow|10 mL of Alcohol Injection|subject randomized to 10ml of dehydrated alcohol
1093816|NCT00578279|O2|Outcome|20 mL of Alcohol Injection|subject randomized to 20ml of dehydrated alcohol
1093817|NCT00578279|O1|Outcome|10 mL of Alcohol Injection|subject randomized to 10ml of dehydrated alcohol
1093818|NCT00578279|E2|Reported Event|20 mL of Alcohol Injection|subject randomized to 20ml of dehydrated alcohol
1093819|NCT00578279|E1|Reported Event|10 mL of Alcohol Injection|subject randomized to 10ml of dehydrated alcohol
1093820|NCT00578227|B4|Baseline|Total|Total of all reporting groups
1093821|NCT00578227|B3|Baseline|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
1093822|NCT00578227|B2|Baseline|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
1093823|NCT00578227|B1|Baseline|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
1093824|NCT00578227|P3|Participant Flow|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
1093825|NCT00578227|P2|Participant Flow|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
1093826|NCT00578227|P1|Participant Flow|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
1093827|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
1093828|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
1093829|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
1093830|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
1093831|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
1093832|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
1093833|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
1093834|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
1093835|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
1093836|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
1093851|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
1093852|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
1093853|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
1093854|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
1093855|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
1094506|NCT00577135|O2|Outcome|Continuous Infusion|
1093866|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
1093867|NCT00578227|O4|Outcome|9-Year Old Cervarix Vaccine Recipients|All 9-year subjects who received 3 doses of HPV vaccine alone or co-administered with HAB vaccine.
1093868|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
1093869|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
1093870|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
1093871|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
1093872|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
1093873|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
1093874|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
1093875|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
1093876|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
1093877|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
1093878|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
1093879|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
1093880|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
1093881|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
1093882|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
1093883|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
1093884|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
1093885|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
1093886|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
1093887|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
1093888|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
1093889|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
1093890|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
1093891|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
1093892|NCT00578227|E3|Reported Event|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
1093893|NCT00578227|E2|Reported Event|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
1093894|NCT00578227|E1|Reported Event|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
1093895|NCT00578214|B4|Baseline|Total|Total of all reporting groups
1093896|NCT00578214|B3|Baseline|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
1093897|NCT00578214|B2|Baseline|Placebo|Randomized patients receiving placebo syrup
1093898|NCT00578214|B1|Baseline|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
1093899|NCT00578214|P3|Participant Flow|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
1093900|NCT00578214|P2|Participant Flow|Placebo|Randomized patients receiving placebo syrup
1093901|NCT00578214|P1|Participant Flow|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
1093902|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
1093903|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
1093904|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
1093905|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
1093906|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
1093907|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
1093908|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
1093909|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
1093910|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
1093911|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
1093912|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
1093913|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
1093914|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
1093920|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
1093921|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
1093922|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
1093923|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
1093924|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
1093925|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
1093926|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
1093927|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
1093928|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
1093929|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
1093930|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
1093931|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
1093932|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
1093933|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
1093934|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
1093935|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
1093936|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
1093937|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
1093938|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
1093939|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
1093940|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
1093941|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
1093942|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
1093943|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
1093944|NCT00578214|E3|Reported Event|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
1093945|NCT00578214|E2|Reported Event|Placebo|Randomized patients receiving placebo syrup
1093946|NCT00578214|E1|Reported Event|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
1093947|NCT00578175|B4|Baseline|Total|Total of all reporting groups
1093948|NCT00578175|B3|Baseline|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
1093949|NCT00578175|B2|Baseline|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1094157|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
1093950|NCT00578175|B1|Baseline|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1093951|NCT00578175|P3|Participant Flow|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
1093952|NCT00578175|P2|Participant Flow|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1093953|NCT00578175|P1|Participant Flow|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1093954|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
1093955|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1093956|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1093957|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
1093958|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1093959|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1093960|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
1093961|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1093962|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1093963|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
1093964|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1093965|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1093966|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
1093967|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1093968|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1093969|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
1094158|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
1093970|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1093971|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1093972|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
1093973|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1093974|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1093975|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
1093976|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1094046|NCT00578071|E1|Reported Event|Chemoradiation|Panitumumab, oxiplatin, capecitabine, radiation therapy
1094047|NCT00577889|B4|Baseline|Total|Total of all reporting groups
1094247|NCT00577460|B2|Baseline|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1093977|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1093978|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
1093979|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1093980|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1093981|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
1093982|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1093983|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1093984|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
1093985|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1093986|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1093987|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
1093988|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1093989|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1093990|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
1093991|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1093992|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1093993|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
1093994|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1093995|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1093996|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
1094100|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
1093997|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1093998|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1093999|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
1094000|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1094001|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1094002|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
1094003|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1094004|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1094005|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
1094006|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1094007|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1094008|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
1094009|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1094159|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
1094010|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1094011|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
1094012|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1094013|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1094014|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
1094015|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1094101|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
1094102|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
1094103|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
1094016|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1094017|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
1094018|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1094019|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1094020|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
1094021|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1094022|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1094023|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
1094024|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1094025|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1094026|NCT00578175|E3|Reported Event|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
1094027|NCT00578175|E2|Reported Event|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1094028|NCT00578175|E1|Reported Event|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
1094029|NCT00578136|B3|Baseline|Total|Total of all reporting groups
1094030|NCT00578136|B2|Baseline|Local Infiltration|2) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.
1094031|NCT00578136|B1|Baseline|Rectus Sheath Block|1) One group will receive the rectus sheath block prior to Umbilical hernia repair.
1094032|NCT00578136|P2|Participant Flow|Local Infiltration|2) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.
1094033|NCT00578136|P1|Participant Flow|Rectus Sheath Block|1) One group will receive the rectus sheath block prior to Umbilical hernia repair.
1094034|NCT00578136|O2|Outcome|Local Infiltration|2) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.
1094035|NCT00578136|O1|Outcome|Rectus Sheath Block|1) One group will receive the rectus sheath block prior to Umbilical hernia repair.
1094036|NCT00578136|O2|Outcome|Local Infiltration|2) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.
1094037|NCT00578136|O1|Outcome|Rectus Sheath Block|1) One group will receive the rectus sheath block prior to Umbilical hernia repair.
1094038|NCT00578136|E2|Reported Event|Local Infiltration|2) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.
1094039|NCT00578136|E1|Reported Event|Rectus Sheath Block|1) One group will receive the rectus sheath block prior to Umbilical hernia repair.
1094040|NCT00578071|B1|Baseline|Chemoradiation|Panitumumab, oxiplatin, capecitabine, radiation therapy
1094041|NCT00578071|P1|Participant Flow|Chemoradiation|Panitumumab, oxiplatin, capecitabine, radiation therapy
1094042|NCT00578071|O1|Outcome|Arm 1 Chemoradiation|Panitumumab, oxiplatin, capecitabine, radiation therapy
1094043|NCT00578071|O1|Outcome|Arm 1 Chemoradiation|Panitumumab, oxiplatin, capecitabine, radiation therapy
1094044|NCT00578071|O1|Outcome|Chemoradiation|Panitumumab, oxiplatin, capecitabine, radiation therapy
1094045|NCT00578071|O1|Outcome|Chemoradiation|Panitumumab, oxiplatin, capecitabine, radiation therapy
1094104|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
1094048|NCT00577889|B3|Baseline|Arm III (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
1094049|NCT00577889|B2|Baseline|Arm II (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
1094050|NCT00577889|B1|Baseline|Arm I (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
1094051|NCT00577889|P3|Participant Flow|Arm III (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
1094052|NCT00577889|P2|Participant Flow|Arm II (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
1094053|NCT00577889|P1|Participant Flow|Arm I (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
1094054|NCT00577889|O3|Outcome|Arm III (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
1094055|NCT00577889|O2|Outcome|Arm II (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
1094056|NCT00577889|O1|Outcome|Arm I (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
1094057|NCT00577889|O3|Outcome|Arm III (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
1094058|NCT00577889|O2|Outcome|Arm II (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
1094059|NCT00577889|O1|Outcome|Arm I (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
1094086|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
1094060|NCT00577889|O3|Outcome|Arm III (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
1094061|NCT00577889|O2|Outcome|Arm II (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
1094062|NCT00577889|O1|Outcome|Arm I (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
1094063|NCT00577889|O3|Outcome|Arm III (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
1094064|NCT00577889|O2|Outcome|Arm II (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
1094105|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
1094106|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 46 weeks.
1094065|NCT00577889|O1|Outcome|Arm I (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
1094066|NCT00577889|E3|Reported Event|Arm III (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
1094067|NCT00577889|E2|Reported Event|Arm II (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
1094068|NCT00577889|E1|Reported Event|Arm I (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
1094069|NCT00577863|B3|Baseline|Total|Total of all reporting groups
1094070|NCT00577863|B2|Baseline|Not Current Users|A Not Current User could be either treatment naïve or have experience with the original device (Forteo 1.1 Pen) that did not meet the criteria outlined for a Current User. Thus, a Not Current User could have used the original delivery device for up to 22 months, as long as they had not used the original device within 4 weeks of enrollment. Patients received teriparatide 20 mcg/day during the study using the Forteo B Pen.
1094071|NCT00577863|B1|Baseline|Current Users|A Current User was defined as a patient with ≥8 weeks experience with the original delivery device (Forteo 1.1 Pen), including uninterrupted use during the 4 weeks prior to enrollment. Patients received teriparatide 20 mcg/day during the study using the Forteo B Pen.
1094072|NCT00577863|P2|Participant Flow|Not Current Users|A Not Current User could be either treatment naïve or have experience with the original device (Forteo 1.1 Pen) that did not meet the criteria outlined for a Current User. Thus, a Not Current User could have used the original delivery device for up to 22 months, as long as they had not used the original device within 4 weeks of enrollment. Patients received teriparatide 20 mcg/day during the study using the Forteo B Pen.
1094073|NCT00577863|P1|Participant Flow|Current Users|A Current User was defined as a patient with ≥8 weeks experience with the original delivery device (Forteo 1.1 Pen), including uninterrupted use during the 4 weeks prior to enrollment. Patients received teriparatide 20 mcg/day during the study using the Forteo B Pen.
1094074|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 46 weeks.
1094075|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 46 weeks.
1094076|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
1094077|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
1094078|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
1094079|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
1094080|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
1094081|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
1094082|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
1094083|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
1094084|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
1094085|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
1094155|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
1094087|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
1094088|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
1094089|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
1094090|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
1094091|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
1094092|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
1094093|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
1094094|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
1094095|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
1094096|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
1094097|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
1094098|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
1094099|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
1094109|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
1094110|NCT00577863|E1|Reported Event|Teriparatide|Teriparatide 20 micrograms per day
1094111|NCT00577824|B4|Baseline|Total|Total of all reporting groups
1094112|NCT00577824|B3|Baseline|Placebo BID|placebo SC, twice daily
1094113|NCT00577824|B2|Baseline|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
1094114|NCT00577824|B1|Baseline|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
1094115|NCT00577824|P3|Participant Flow|Placebo BID|placebo SC, twice daily
1094116|NCT00577824|P2|Participant Flow|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
1094117|NCT00577824|P1|Participant Flow|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
1094118|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
1094119|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
1094120|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
1094121|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
1094122|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
1094123|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
1094124|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
1094125|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
1094126|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
1094127|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
1094128|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
1094129|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
1094130|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
1094131|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
1094132|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
1094133|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
1094134|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
1094135|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
1094136|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
1094137|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
1094138|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
1094139|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
1094140|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
1094141|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
1094142|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
1094143|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
1094144|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
1094145|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
1094146|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
1094147|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
1094148|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
1094149|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
1094150|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
1094151|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
1094152|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
1094153|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
1094154|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
1094161|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
1094162|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
1094163|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
1094164|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
1094165|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
1094166|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
1094167|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
1094168|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
1094169|NCT00577824|E3|Reported Event|Placebo BID|placebo SC, twice daily
1094170|NCT00577824|E2|Reported Event|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
1094171|NCT00577824|E1|Reported Event|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
1094172|NCT00577772|B3|Baseline|Total|Total of all reporting groups
1094173|NCT00577772|B2|Baseline|Symptomatic Participants|"Subjects with symptoms suggestive of small bowel bacterial overgrowth (SBBO) (e.g., diarrhea, bloating, abdominal discomfort) for at least 3 months will be divided into 2 groups based on the results of their previous testing for SBBO (5 SBBO positive patients, 5 SBBO negative patients).~The symptomatic participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the SmartPill Capsule 5 days later.~After the capsule has been demonstrated to be passed from the subject, the subjects with SBBO present will then enter into an open-label treatment using Rifaximin (400 mg PO TID) for 7 days."
1094174|NCT00577772|B1|Baseline|Healthy Participants|Healthy Participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the SmartPill Capsule 5 days later.
1094201|NCT00577720|O1|Outcome|35 mg IRBB (Immediate Release Before Breakfast)|35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
1094202|NCT00577720|E4|Reported Event|50 mg DRBB (Delayed Release Before Breakfast)|50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
1094203|NCT00577720|E3|Reported Event|50 mg DRFB|50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
1094364|NCT00577395|O2|Outcome|Placebo Tablet Once a Month|Placebo tablet once a month, orally
1094175|NCT00577772|P2|Participant Flow|Symptomatic Participants|"Subjects with symptoms suggestive of small bowel bacterial overgrowth (SBBO) (e.g., diarrhea, bloating, abdominal discomfort) for at least 3 months will be divided into 2 groups based on the results of their previous testing for SBBO (5 SBBO positive patients, 5 SBBO negative patients).~The symptomatic participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the SmartPill Capsule 5 days later.~After the capsule has been demonstrated to be passed from the subject, the subjects with SBBO present will then enter into an open-label treatment using Rifaximin (400 mg PO TID) for 7 days."
1094176|NCT00577772|P1|Participant Flow|Healthy Participants|Healthy Participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the SmartPill Capsule 5 days later.
1094177|NCT00577772|O2|Outcome|Symptomatic Participants|"Subjects with symptoms suggestive of small bowel bacterial overgrowth (SBBO) (e.g., diarrhea, bloating, abdominal discomfort) for at least 3 months will be divided into 2 groups based on the results of their previous testing for SBBO (5 SBBO positive patients, 5 SBBO negative patients).~The symptomatic participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the data recorder 5 days later.~After the capsule has been demonstrated to be passed from the subject, the subjects with SBBO present will then enter into an open-label treatment using Rifaximin (400 mg PO TID) for 7 days."
1094178|NCT00577772|O1|Outcome|Healthy Participants|Healthy Participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the data recorder 5 days later.
1094179|NCT00577772|E2|Reported Event|Symptomatic Participants|"Subjects with symptoms suggestive of small bowel bacterial overgrowth (SBBO) (e.g., diarrhea, bloating, abdominal discomfort) for at least 3 months will be divided into 2 groups based on the results of their previous testing for SBBO (5 SBBO positive patients, 5 SBBO negative patients).~The symptomatic participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the data recorder 5 days later.~After the capsule has been demonstrated to be passed from the subject, the subjects with SBBO present will then enter into an open-label treatment using Rifaximin (400 mg PO TID) for 7 days."
1094180|NCT00577772|E1|Reported Event|Healthy Participants|Healthy Participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the data recorder 5 days later.
1094181|NCT00577720|B5|Baseline|Total|Total of all reporting groups
1094182|NCT00577720|B4|Baseline|50 mg DRBB (Delayed Release Before Breakfast)|50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
1094183|NCT00577720|B3|Baseline|50 mg DRFB|50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
1094184|NCT00577720|B2|Baseline|35 mg DRFB (Delayed Release Following Breakfast)|35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
1094185|NCT00577720|B1|Baseline|35 mg IRBB (Immediate Release Before Breakfast)|35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
1094186|NCT00577720|P4|Participant Flow|50 mg DRBB (Delayed Release Before Breakfast)|50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
1094187|NCT00577720|P3|Participant Flow|50 mg DRFB|50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
1094281|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
1094188|NCT00577720|P2|Participant Flow|35 mg DRFB (Delayed Release Following Breakfast)|35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
1094189|NCT00577720|P1|Participant Flow|35 mg IRBB (Immediate Release Before Breakfast)|35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
1094190|NCT00577720|O4|Outcome|50 mg DRBB (Delayed Release Before Breakfast)|50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
1094191|NCT00577720|O3|Outcome|50 mg DRFB|50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
1094192|NCT00577720|O2|Outcome|35 mg DRFB (Delayed Release Following Breakfast)|35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
1094193|NCT00577720|O1|Outcome|35 mg IRBB (Immediate Release Before Breakfast)|35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
1094194|NCT00577720|O4|Outcome|50 mg DRBB (Delayed Release Before Breakfast)|50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
1094195|NCT00577720|O3|Outcome|50 mg DRFB|50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
1094196|NCT00577720|O2|Outcome|35 mg DRFB (Delayed Release Following Breakfast)|35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
1094197|NCT00577720|O1|Outcome|35 mg IRBB (Immediate Release Before Breakfast)|35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
1094198|NCT00577720|O4|Outcome|50 mg DRBB (Delayed Release Before Breakfast)|50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
1094199|NCT00577720|O3|Outcome|50 mg DRFB|50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
1094200|NCT00577720|O2|Outcome|35 mg DRFB (Delayed Release Following Breakfast)|35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
1094204|NCT00577720|E2|Reported Event|35 mg DRFB (Delayed Release Following Breakfast)|35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
1094205|NCT00577720|E1|Reported Event|35 mg IRBB (Immediate Release Before Breakfast)|35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
1094206|NCT00577707|B1|Baseline|Patients With Stage IB-IIIA NSCLC With EGFR Mutations|Phase II Study of Erlotinib and Chemotherapy for Patients with Stage IB-IIIA NSCLC with EGFR Mutations
1094207|NCT00577707|P1|Participant Flow|Patients With Stage IB-IIIA NSCLC With EGFR Mutations|Phase II Study of Erlotinib and Chemotherapy for Patients with Stage IB-IIIA NSCLC with EGFR Mutations
1094208|NCT00577707|O1|Outcome|Patients With Stage IB-IIIA NSCLC With EGFR Mutations|Phase II Study of Erlotinib and Chemotherapy for Patients with Stage IB-IIIA NSCLC with EGFR Mutations
1094209|NCT00577707|E1|Reported Event|Patients With Stage IB-IIIA NSCLC With EGFR Mutations|Phase II Study of Erlotinib and Chemotherapy for Patients with Stage IB-IIIA NSCLC with EGFR Mutations
1094210|NCT00577512|B1|Baseline|HD DTPACE|"High dose DTPACE and stem cell collection if you do not already have sufficient stem cells stored~High dose DTPACE and stem cell re-infusion~VTD Maintenance therapy"
1094211|NCT00577512|P1|Participant Flow|HD DTPACE|"High dose DTPACE and stem cell collection if you do not already have sufficient stem cells stored~High dose DTPACE and stem cell re-infusion~VTD Maintenance therapy"
1094212|NCT00577512|O1|Outcome|HD DTPACE|"High dose DTPACE and stem cell collection if you do not already have sufficient stem cells stored~High dose DTPACE and stem cell re-infusion~VTD Maintenance therapy"
1094213|NCT00577512|E1|Reported Event|HD DTPACE|"High dose DTPACE and stem cell collection if you do not already have sufficient stem cells stored~High dose DTPACE and stem cell re-infusion~VTD Maintenance therapy"
1094214|NCT00577473|B3|Baseline|Total|Total of all reporting groups
1094215|NCT00577473|B2|Baseline|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
1094216|NCT00577473|B1|Baseline|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
1094217|NCT00577473|P2|Participant Flow|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
1094218|NCT00577473|P1|Participant Flow|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
1094219|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
1094220|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
1094221|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
1094222|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
1094223|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
1094224|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
1094225|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
1094226|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
1094227|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
1094228|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
1094282|NCT00577460|O3|Outcome|PPX IR|Treatment with Pramipexole IR in previous trial
1094229|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
1094230|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
1094231|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
1094232|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
1094233|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
1094234|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
1094235|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
1094236|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
1094237|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
1094238|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
1094239|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
1094240|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
1094241|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
1094242|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
1094243|NCT00577473|E2|Reported Event|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
1094244|NCT00577473|E1|Reported Event|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
1094245|NCT00577460|B4|Baseline|Total|Total of all reporting groups
1094246|NCT00577460|B3|Baseline|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
1094490|NCT00577135|O2|Outcome|Continuous Infusion|
1094248|NCT00577460|B1|Baseline|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
1094249|NCT00577460|P3|Participant Flow|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole Immediate Release (IR) in previous trial
1094250|NCT00577460|P2|Participant Flow|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1094251|NCT00577460|P1|Participant Flow|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
1094252|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
1094253|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1094254|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
1094255|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
1094256|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1094257|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
1094258|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
1094259|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1094260|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
1094261|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
1094262|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1094263|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
1094264|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
1094265|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1094266|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
1094267|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
1094268|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1094269|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
1094270|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
1094271|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1094272|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
1094273|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
1094274|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1094275|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
1094276|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
1094277|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1094278|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
1094279|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
1094280|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1094441|NCT00577135|O3|Outcome|Low Intensification|
1094283|NCT00577460|O2|Outcome|PPX ER|Treatment with Pramipexole ER in previous trial
1094284|NCT00577460|O1|Outcome|Placebo|Treatment with matching placebo in previous trial (NCT00466167)
1094285|NCT00577460|O4|Outcome|Total PPX ER|Pramipexole ER, all patients
1094286|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
1094287|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1094288|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
1094289|NCT00577460|O4|Outcome|Total PPX ER|Pramipexole ER, all patients
1094290|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
1094291|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1094292|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
1094293|NCT00577460|O4|Outcome|Total PPX ER|Pramipexole ER, all patients
1094294|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
1094295|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1094296|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
1094297|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
1094298|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1094299|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
1094300|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
1094301|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1094302|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
1094303|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
1094304|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1094305|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
1094306|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
1094307|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1094308|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
1094309|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
1094310|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1094311|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
1094312|NCT00577460|O4|Outcome|Total PPX ER|Pramipexole ER, all patients
1094313|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
1094314|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1094315|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
1094316|NCT00577460|O4|Outcome|Total PPX ER|Pramipexole ER, all patients
1094317|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
1094318|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1094319|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
1094320|NCT00577460|O4|Outcome|Total PPX ER|Pramipexole ER, all patients
1094321|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
1094322|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1094323|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
1094324|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
1094325|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1094326|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
1094327|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
1094328|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1094329|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
1094330|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
1094331|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1094332|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
1094333|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
1094334|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1094335|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
1094336|NCT00577460|O4|Outcome|Total PPX ER|Pramipexole ER, all patients
1094337|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
1094338|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1094339|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
1094340|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
1094341|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1094342|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
1094343|NCT00577460|O2|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
1094344|NCT00577460|O1|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1094345|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
1094346|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1094347|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
1094348|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
1094349|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1094350|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
1094351|NCT00577460|O2|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
1094352|NCT00577460|O1|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1094353|NCT00577460|E4|Reported Event|Total PPX ER|Pramipexole ER, all patients
1094354|NCT00577460|E3|Reported Event|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
1094355|NCT00577460|E2|Reported Event|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
1094356|NCT00577460|E1|Reported Event|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
1094357|NCT00577395|B3|Baseline|Total|Total of all reporting groups
1094358|NCT00577395|B2|Baseline|Placebo Tablet Once a Month|Placebo tablet once a month, orally
1094359|NCT00577395|B1|Baseline|One 150 mg Risedronate Once a Month|one 150 mg risedronate once a month, orally
1094360|NCT00577395|P2|Participant Flow|Placebo Tablet Once a Month|Placebo tablet once a month, orally
1094361|NCT00577395|P1|Participant Flow|One 150 mg Risedronate Once a Month|one 150 mg risedronate once a month, orally
1094362|NCT00577395|O2|Outcome|Placebo Tablet Once a Month|Placebo tablet once a month, orally
1094363|NCT00577395|O1|Outcome|One 150 mg Risedronate Once a Month|one 150 mg risedronate once a month, orally
1094365|NCT00577395|O1|Outcome|One 150 mg Risedronate Once a Month|one 150 mg risedronate once a month, orally
1094366|NCT00577395|E2|Reported Event|Placebo Tablet Once a Month|Placebo tablet once a month, orally
1094367|NCT00577395|E1|Reported Event|One 150 mg Risedronate Once a Month|one 150 mg risedronate once a month, orally
1094368|NCT00577382|B3|Baseline|Total|Total of all reporting groups
1094369|NCT00577382|B2|Baseline|Cohort B-Sunitinib Continuous Dosing|Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
1094370|NCT00577382|B1|Baseline|Cohort A-Sunitinib Intermittent Dosing|Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
1094371|NCT00577382|P2|Participant Flow|Cohort B-Sunitinib Continuous Dosing|Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
1094372|NCT00577382|P1|Participant Flow|Cohort A-Sunitinib Intermittent Dosing|Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
1094373|NCT00577382|O2|Outcome|Cohort B-Sunitinib Continuous Dosing|Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
1094374|NCT00577382|O1|Outcome|Cohort A-Sunitinib Intermittent Dosing|Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
1094375|NCT00577382|O2|Outcome|Cohort B-Sunitinib Continuous Dosing|Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
1094376|NCT00577382|O1|Outcome|Cohort A-Sunitinib Intermittent Dosing|Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
1094377|NCT00577382|O2|Outcome|Cohort B-Sunitinib Continuous Dosing|Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
1094378|NCT00577382|O1|Outcome|Cohort A-Sunitinib Intermittent Dosing|Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
1094379|NCT00577382|O2|Outcome|Cohort B-Sunitinib Continuous Dosing|Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
1094380|NCT00577382|O1|Outcome|Cohort A-Sunitinib Intermittent Dosing|Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
1094381|NCT00577382|E2|Reported Event|Cohort B-Sunitinib Continuous Dosing|Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
1094382|NCT00577382|E1|Reported Event|Cohort A-Sunitinib Intermittent Dosing|Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
1094442|NCT00577135|O2|Outcome|Continuous Infusion|
1094443|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
1094444|NCT00577135|O4|Outcome|High Intensification|
1094445|NCT00577135|O3|Outcome|Low Intensification|
1094446|NCT00577135|O2|Outcome|Continuous Infusion|
1094383|NCT00577356|B1|Baseline|CG1940/CG8711 (Immunotherapy Drug)|Patients were given a prime immunotherapy of 5 x 108 cells consisting of equal amounts of CG1940 and CG8711 followed 21 days later by boost immunotherapies of 3 x 108 cells consisting of equal amounts of CG1940 and CG8711 every 21 days for the first 4 immunotherapies. (given 2 to 3 days after docetaxel) for a total of 4 immunotherapies, followed by a fifth dose given at 2, 8, or 14 days prior to prostatectomy, and then beginning at 3 – 6 weeks post-operatively an additional 6 immunotherapies every 14 days for a combined total of 11 immunotherapies. Docetaxel chemotherapy was administered intravenously starting day 1 of the first week and given every 3 weeks thereafter for a total of 4 cycles. A cycle is defined as every 21 days (3 weeks).
1094384|NCT00577356|P1|Participant Flow|CG1940/CG8711 (Immunotherapy Drug)|Patients were given a prime immunotherapy of 5 x 108 cells consisting of equal amounts of CG1940 and CG8711 followed 21 days later by boost immunotherapies of 3 x 108 cells consisting of equal amounts of CG1940 and CG8711 every 21 days for the first 4 immunotherapies. (given 2 to 3 days after docetaxel) for a total of 4 immunotherapies, followed by a fifth dose given at 2, 8, or 14 days prior to prostatectomy, and then beginning at 3 – 6 weeks post-operatively an additional 6 immunotherapies every 14 days for a combined total of 11 immunotherapies. Docetaxel chemotherapy was administered intravenously starting day 1 of the first week and given every 3 weeks thereafter for a total of 4 cycles. A cycle is defined as every 21 days (3 weeks).
1094385|NCT00577356|O1|Outcome|CG1940/CG8711 (Immunotherapy Drug)|Patients were given a prime immunotherapy of 5 x 108 cells consisting of equal amounts of CG1940 and CG8711 followed 21 days later by boost immunotherapies of 3 x 108 cells consisting of equal amounts of CG1940 and CG8711 every 21 days for the first 4 immunotherapies. (given 2 to 3 days after docetaxel) for a total of 4 immunotherapies, followed by a fifth dose given at 2, 8, or 14 days prior to prostatectomy, and then beginning at 3 – 6 weeks post-operatively an additional 6 immunotherapies every 14 days for a combined total of 11 immunotherapies. Docetaxel chemotherapy was administered intravenously starting day 1 of the first week and given every 3 weeks thereafter for a total of 4 cycles. A cycle is defined as every 21 days (3 weeks).
1094491|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
1094492|NCT00577135|O4|Outcome|High Intensification|
1094493|NCT00577135|O3|Outcome|Low Intensification|
1094494|NCT00577135|O2|Outcome|Continuous Infusion|
1094495|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
1094496|NCT00577135|O4|Outcome|High Intensification|
1094497|NCT00577135|O3|Outcome|Low Intensification|
1094498|NCT00577135|O2|Outcome|Continuous Infusion|
1094499|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
1094500|NCT00577135|O4|Outcome|High Intensification|
1094386|NCT00577356|E1|Reported Event|CG1940/CG8711 (Immunotherapy Drug)|Patients were given a prime immunotherapy of 5 x 108 cells consisting of equal amounts of CG1940 and CG8711 followed 21 days later by boost immunotherapies of 3 x 108 cells consisting of equal amounts of CG1940 and CG8711 every 21 days for the first 4 immunotherapies. (given 2 to 3 days after docetaxel) for a total of 4 immunotherapies, followed by a fifth dose given at 2, 8, or 14 days prior to prostatectomy, and then beginning at 3 – 6 weeks post-operatively an additional 6 immunotherapies every 14 days for a combined total of 11 immunotherapies. Docetaxel chemotherapy was administered intravenously starting day 1 of the first week and given every 3 weeks thereafter for a total of 4 cycles. A cycle is defined as every 21 days (3 weeks).
1094387|NCT00577135|B5|Baseline|Total|Total of all reporting groups
1094388|NCT00577135|B4|Baseline|Continuous Infusion & High Intensification|
1094389|NCT00577135|B3|Baseline|Continuous Infusion & Low Intensification|
1094390|NCT00577135|B2|Baseline|Q12 Hours Bolus & High Intensification|
1094391|NCT00577135|B1|Baseline|Q12 Hours Bolus & Low Intensification|
1094392|NCT00577135|P4|Participant Flow|Continuous Infusion & High Intensification|High intensification (2.5 x oral dose) IV furosemide by continuous infusion
1094393|NCT00577135|P3|Participant Flow|Continuous Infusion & Low Intensification|Low intensification (1 x oral dose) IV furosemide by continuous infusion
1094394|NCT00577135|P2|Participant Flow|Q12 Hours Bolus & High Intensification|High intensification (2.5 x oral dose) IV furosemide by Q12 hours bolus
1094395|NCT00577135|P1|Participant Flow|Q12 Hours Bolus & Low Intensification|Low intensification (1 x oral dose) IV furosemide by Q12 hours bolus
1094396|NCT00577135|O4|Outcome|High Intensification|
1094397|NCT00577135|O3|Outcome|Low Intensification|
1094398|NCT00577135|O2|Outcome|Continuous Infusion|
1094399|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
1094400|NCT00577135|O4|Outcome|High Intensification|
1094401|NCT00577135|O3|Outcome|Low Intensification|
1094402|NCT00577135|O2|Outcome|Continuous Infusion|
1094403|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
1094404|NCT00577135|O4|Outcome|High Intensification|
1094405|NCT00577135|O3|Outcome|Low Intensification|
1094406|NCT00577135|O2|Outcome|Continuous Infusion|
1094407|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
1094408|NCT00577135|O4|Outcome|High Intensification|
1094409|NCT00577135|O3|Outcome|Low Intensification|
1094410|NCT00577135|O2|Outcome|Continuous Infusion|
1094411|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
1094412|NCT00577135|O4|Outcome|High Intensification|
1094413|NCT00577135|O3|Outcome|Low Intensification|
1094414|NCT00577135|O2|Outcome|Continuous Infusion|
1094415|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
1094416|NCT00577135|O4|Outcome|High Intensification|
1094417|NCT00577135|O3|Outcome|Low Intensification|
1094418|NCT00577135|O2|Outcome|Continuous Infusion|
1094419|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
1094420|NCT00577135|O4|Outcome|High Intensification|
1094421|NCT00577135|O3|Outcome|Low Intensification|
1094422|NCT00577135|O2|Outcome|Continuous Infusion|
1094423|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
1094424|NCT00577135|O4|Outcome|High Intensification|
1094425|NCT00577135|O3|Outcome|Low Intensification|
1094426|NCT00577135|O2|Outcome|Continuous Infusion|
1094427|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
1094428|NCT00577135|O4|Outcome|High Intensification|
1094429|NCT00577135|O3|Outcome|Low Intensification|
1094430|NCT00577135|O2|Outcome|Continuous Infusion|
1094431|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
1094432|NCT00577135|O4|Outcome|High Intensification|
1094433|NCT00577135|O3|Outcome|Low Intensification|
1094434|NCT00577135|O2|Outcome|Continuous Infusion|
1094435|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
1094436|NCT00577135|O4|Outcome|High Intensification|
1094437|NCT00577135|O3|Outcome|Low Intensification|
1094438|NCT00577135|O2|Outcome|Continuous Infusion|
1094439|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
1094440|NCT00577135|O4|Outcome|High Intensification|
1094457|NCT00577135|O3|Outcome|Low Intensification|
1094458|NCT00577135|O2|Outcome|Continuous Infusion|
1094459|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
1094460|NCT00577135|O4|Outcome|High Intensification|
1094461|NCT00577135|O3|Outcome|Low Intensification|
1094462|NCT00577135|O2|Outcome|Continuous Infusion|
1094463|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
1094464|NCT00577135|O4|Outcome|High Intensification|
1094465|NCT00577135|O3|Outcome|Low Intensification|
1094466|NCT00577135|O2|Outcome|Continuous Infusion|
1094467|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
1094468|NCT00577135|O4|Outcome|High Intensification|
1094469|NCT00577135|O3|Outcome|Low Intensification|
1094470|NCT00577135|O2|Outcome|Continuous Infusion|
1094471|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
1094472|NCT00577135|O4|Outcome|High Intensification|
1094473|NCT00577135|O3|Outcome|Low Intensification|
1094474|NCT00577135|O2|Outcome|Continuous Infusion|
1094475|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
1094476|NCT00577135|O4|Outcome|High Intensification|
1094477|NCT00577135|O3|Outcome|Low Intensification|
1094478|NCT00577135|O2|Outcome|Continuous Infusion|
1094479|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
1094480|NCT00577135|O4|Outcome|High Intensification|
1094481|NCT00577135|O3|Outcome|Low Intensification|
1094482|NCT00577135|O2|Outcome|Continuous Infusion|
1094483|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
1094484|NCT00577135|O4|Outcome|High Intensification|
1094485|NCT00577135|O3|Outcome|Low Intensification|
1094486|NCT00577135|O2|Outcome|Continuous Infusion|
1094487|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
1094488|NCT00577135|O4|Outcome|High Intensification|
1094489|NCT00577135|O3|Outcome|Low Intensification|
1094507|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
1094508|NCT00577135|E4|Reported Event|High Intensification|
1094509|NCT00577135|E3|Reported Event|Low Intensification|
1094510|NCT00577135|E2|Reported Event|Continuous Infusion|
1094511|NCT00577135|E1|Reported Event|Q 12 Hour Bolus|
1094512|NCT00577122|B3|Baseline|Total|Total of all reporting groups
1094513|NCT00577122|B2|Baseline|Cohort 2: MPA+IdoCM|"Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.~Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week."
1094514|NCT00577122|B1|Baseline|Cohort 1: MPA-Alone|Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
1094515|NCT00577122|P2|Participant Flow|Cohort 2: MPA+IdoCM|"Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.~Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week."
1094516|NCT00577122|P1|Participant Flow|Cohort 1: MPA-Alone|Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
1094517|NCT00577122|O2|Outcome|Cohort II: MPA+IdoCM|"Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.~Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week."
1094518|NCT00577122|O1|Outcome|Cohort I: MPA-Alone|Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
1094519|NCT00577122|O2|Outcome|Cohort II: MPA+IdoCM|"Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.~Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week."
1094520|NCT00577122|O1|Outcome|Cohort I: MPA-Alone|Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
1094521|NCT00577122|O2|Outcome|Cohort II: MPA+IdoCM|"Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.~Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week."
1094522|NCT00577122|O1|Outcome|Cohort I: MPA-Alone|Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
1094523|NCT00577122|O2|Outcome|Cohort 2: MPA+IdoCM|"Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.~Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week."
1094524|NCT00577122|O1|Outcome|Cohort I: MPA-Alone|Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
1094525|NCT00577122|E2|Reported Event|Cohort 2: MPA+IdoCM|"Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.~Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week."
1094526|NCT00577122|E1|Reported Event|Cohort 1: MPA Alone|Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
1094527|NCT00577096|B3|Baseline|Total|Total of all reporting groups
1095862|NCT00573261|O1|Outcome|Placebo|Placebo
1094528|NCT00577096|B2|Baseline|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
1094529|NCT00577096|B1|Baseline|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
1094530|NCT00577096|P2|Participant Flow|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
1094567|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
1095149|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
1094531|NCT00577096|P1|Participant Flow|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
1094532|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
1094533|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
1094534|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
1094560|NCT00577083|O1|Outcome|Initial Cap-fitted|"Initial cap-fitted colonoscopy for the first insertion~Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
1094769|NCT00576524|E1|Reported Event|Sham Device|A group of subjects will be randomized to receive the placebo sham device.
1094535|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
1094536|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
1094537|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
1094538|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
1094539|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
1094540|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
1094541|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
1094561|NCT00577083|E2|Reported Event|Initial Cap-fitted|"Initial cap-fitted colonoscopy for the first insertion~Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
1094770|NCT00576472|B16|Baseline|Total|Total of all reporting groups
1095863|NCT00573261|O2|Outcome|Pregabalin|Pregabalin
1094542|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
1094543|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
1094544|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
1094545|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
1094546|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
1094547|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
1094548|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
1094562|NCT00577083|E1|Reported Event|Initial Regular|"no cap on the end of the colonoscope for the first insertion~Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
1094771|NCT00576472|B15|Baseline|Home Maintenance Phase|Methylphenidate (MPH) was administered for 12 months during the duration of the Home Maintenance Phase.
1094549|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
1094550|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
1094551|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
1094552|NCT00577096|E2|Reported Event|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
1094553|NCT00577096|E1|Reported Event|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
1094554|NCT00577083|B3|Baseline|Total|Total of all reporting groups
1094555|NCT00577083|B2|Baseline|Initial Cap-fitted First Then No Cap|"Initial cap-fitted colonoscopy for the first insertion~Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
1094556|NCT00577083|B1|Baseline|No Cap First, Then Cap Fitted|"no cap on the end of the colonoscope for the first insertion~Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
1094557|NCT00577083|P2|Participant Flow|Initial Cap-fitted First, Then No Cap|"Initial cap-fitted colonoscopy for the first insertion~Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
1094558|NCT00577083|P1|Participant Flow|No Cap First, Then Cap-fitted|"no cap on the end of the colonoscope for the first insertion~Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
1094559|NCT00577083|O2|Outcome|Initial Regular|"no cap on the end of the colonoscope for the first insertion~Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
1095747|NCT00573469|E3|Reported Event|Placebo|An enteric capsule without D9421-C was given once daily.
1094563|NCT00577031|B1|Baseline|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
1094564|NCT00577031|P1|Participant Flow|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenously (IV) and oxaliplatin 130 mg per square meter (mg/m^2) IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression, participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
1094565|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
1094566|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
1094605|NCT00576927|O2|Outcome|Placebo|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.
1094606|NCT00576927|O1|Outcome|Ramelteon|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.
1094705|NCT00576732|O1|Outcome|Placebo|Double-blind Period. Oral solution for 6 weeks.
1094568|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
1094569|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
1094570|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
1094571|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
1094572|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
1094573|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
1094574|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles):If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
1094592|NCT00577005|O1|Outcome|Levetiracetam 3000mg + Methadone|"Participants were inducted onto methadone during the first week of study participation and then started on Levetiracetam 500mg in the mornings of the first day of week 2. The dose was titrated every third day on a twice day schedule, until the target dose of 3000mg/day was achieved or to the subject's maximum tolerated dose (MTD) by week 4.~Levetiracetam: 3000mg orally everyday for 12 weeks"
1094575|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles):If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
1094576|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
1094577|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles):~Participants received bevacizumab 7.5 mg/kg IV) and oxaliplatin 130 mg mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day~1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles):~If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
1094578|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
1094579|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
1094909|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
1094580|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV) and oxaliplatin 130 mg mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
1094581|NCT00577031|E1|Reported Event|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV) and oxaliplatin 130 mg mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression, participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
1094582|NCT00577005|B3|Baseline|Total|Total of all reporting groups
1094583|NCT00577005|B2|Baseline|Placebo|"matching placebo~Placebo"
1094584|NCT00577005|B1|Baseline|Levetiracetam|"Levetiracetam tablets~levetiracetam: The participants will start receiving Levetiracetam 500mg in the mornings of the first day on week 2. The dose will be titrated every third day, until the target dose of 3000mg/day is achieved by week 4. The study medication must be titrated to 3000 mg/day or to the subject's maximum tolerated dose (MTD). The physician overseeing this titration as well as all study staff will be blind to the subject's medication administration. The medication will be discontinued over a two-week period."
1094585|NCT00577005|P2|Participant Flow|Levetiracetam 0mg + Methadone|"Participants were inducted onto methadone during the first week of study participation. Matching placebo capsules were started on week 2. The placebo capsules were given on a twice a day schedule until week 13.~Placebo: Placebo orally everyday for 13 weeks"
1094586|NCT00577005|P1|Participant Flow|Levetiracetam 3000mg + Methadone|"Participants were inducted onto methadone during the first week of study participation and then started on Levetiracetam 500mg in the mornings of the first day of week 2. The dose was titrated every third day on a twice day schedule, until the target dose of 3000mg/day was achieved or to the subject's maximum tolerated dose (MTD) by week 4.~Levetiracetam: 3000mg orally everyday for 12 weeks"
1094587|NCT00577005|O2|Outcome|Placebo|"matching placebo~Placebo"
1094588|NCT00577005|O1|Outcome|Levetiracetam|"Levetiracetam tablets~levetiracetam: The participants will start receiving Levetiracetam 500mg in the mornings of the first day on week 2. The dose will be titrated every third day, until the target dose of 3000mg/day is achieved by week 4. The study medication must be titrated to 3000 mg/day or to the subject's maximum tolerated dose (MTD). The physician overseeing this titration as well as all study staff will be blind to the subject's medication administration. The medication will be discontinued over a two-week period."
1094589|NCT00577005|O2|Outcome|Levetiracetam 0mg + Methadone|"Participants were inducted onto methadone during the first week of study participation. Matching placebo capsules were started on week 2. The placebo capsules were given on a twice a day schedule until week 13.~Placebo: Placebo orally everyday for 13 weeks"
1094590|NCT00577005|O1|Outcome|Levetiracetam 3000mg + Methadone|"Participants were inducted onto methadone during the first week of study participation and then started on Levetiracetam 500mg in the mornings of the first day of week 2. The dose was titrated every third day on a twice day schedule, until the target dose of 3000mg/day was achieved or to the subject's maximum tolerated dose (MTD) by week 4.~Levetiracetam: 3000mg orally everyday for 12 weeks"
1094591|NCT00577005|O2|Outcome|Levetiracetam 0mg + Methadone|"Participants were inducted onto methadone during the first week of study participation. Matching placebo capsules were started on week 2. The placebo capsules were given on a twice a day schedule until week 13.~Placebo: Placebo orally everyday for 13 weeks"
1094619|NCT00576823|B4|Baseline|Total|Total of all reporting groups
1095864|NCT00573261|O1|Outcome|Placebo|Placebo
1094593|NCT00577005|O2|Outcome|Levetiracetam 0mg + Methadone|"Participants were inducted onto methadone during the first week of study participation. Matching placebo capsules were started on week 2. The placebo capsules were given on a twice a day schedule until week 13.~Placebo: Placebo orally everyday for 13 weeks"
1094594|NCT00577005|O1|Outcome|Levetiracetam 3000mg + Methadone|"Participants were inducted onto methadone during the first week of study participation and then started on Levetiracetam 500mg in the mornings of the first day of week 2. The dose was titrated every third day on a twice day schedule, until the target dose of 3000mg/day was achieved or to the subject's maximum tolerated dose (MTD) by week 4.~Levetiracetam: 3000mg orally everyday for 12 weeks"
1094595|NCT00577005|E2|Reported Event|Levetiracetam 0mg + Methadone|"Participants were inducted onto methadone during the first week of study participation. Matching placebo capsules were started on week 2. The placebo capsules were given on a twice a day schedule until week 13.~Placebo: Placebo orally everyday for 13 weeks"
1094596|NCT00577005|E1|Reported Event|Levetiracetam 3000mg + Methadone|"Participants were inducted onto methadone during the first week of study participation and then started on Levetiracetam 500mg in the mornings of the first day of week 2. The dose was titrated every third day on a twice day schedule, until the target dose of 3000mg/day was achieved or to the subject's maximum tolerated dose (MTD) by week 4.~Levetiracetam: 3000mg orally everyday for 12 weeks"
1094597|NCT00576927|B3|Baseline|Total|Total of all reporting groups
1094598|NCT00576927|B2|Baseline|Placebo|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.
1094599|NCT00576927|B1|Baseline|Ramelteon|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.
1094600|NCT00576927|P1|Participant Flow|All Subjects|
1094601|NCT00576927|O2|Outcome|Placebo|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.
1094602|NCT00576927|O1|Outcome|Ramelteon|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.
1094603|NCT00576927|O2|Outcome|Placebo|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.
1094604|NCT00576927|O1|Outcome|Ramelteon|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.
1094607|NCT00576927|O2|Outcome|Placebo|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.
1094608|NCT00576927|O1|Outcome|Ramelteon|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.
1094609|NCT00576927|E2|Reported Event|Placebo|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.
1094610|NCT00576927|E1|Reported Event|Ramelteon|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.
1094611|NCT00576901|B1|Baseline|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
1094612|NCT00576901|P1|Participant Flow|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 milligrams per kilogram (mg/kg), intravenously (IV), on Day 1; docetaxel 75 mg per square meter (mg/m^2), IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
1094613|NCT00576901|O1|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
1094614|NCT00576901|O1|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
1094615|NCT00576901|O1|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
1094616|NCT00576901|O1|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
1094617|NCT00576901|O1|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
1094618|NCT00576901|E1|Reported Event|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
1094620|NCT00576823|B3|Baseline|Alfuzosin Tablet - 8-16 Years|Alfuzosin tablet, daily dose divided in 2 doses given at breakfast and dinner to children and adolescents 8-16 years of age who were able to swallow the tablets and had a body weight ≥ 30 kg.
1094621|NCT00576823|B2|Baseline|Alfuzosin Solution - 8-16 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow the tablets or preferred to take the solution or had a body weight < 30 kg.
1094622|NCT00576823|B1|Baseline|Alfuzosin Solution - 2-7 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age.
1094623|NCT00576823|P3|Participant Flow|Alfuzosin Tablet - 8-16 Years|Alfuzosin tablet, daily dose divided in 2 doses given at breakfast and dinner to children and adolescents 8-16 years of age who were able to swallow the tablets and had a body weight ≥ 30 kg.
1094624|NCT00576823|P2|Participant Flow|Alfuzosin Solution - 8-16 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow the tablets or preferred to take the solution or had a body weight < 30 kg.
1094625|NCT00576823|P1|Participant Flow|Alfuzosin Solution - 2-7 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age.
1094626|NCT00576823|O3|Outcome|Alfuzosin Tablet - 8-16 Years|
1094627|NCT00576823|O2|Outcome|Alfuzosin Solution - 8-16 Years|
1094628|NCT00576823|O1|Outcome|Alfuzosin Solution - 2-7 Years|
1094629|NCT00576823|O3|Outcome|Alfuzosin Tablet - 8-16 Years|
1094630|NCT00576823|O2|Outcome|Alfuzosin Solution - 8-16 Years|
1094631|NCT00576823|O1|Outcome|Alfuzosin Solution - 2-7 Years|
1094632|NCT00576823|O3|Outcome|Alfuzosin Tablet - 8-16 Years|Alfuzosin tablet, daily dose divided in 2 doses given at breakfast and dinner to children and adolescents 8-16 years of age who were able to swallow the tablets and had a body weight ≥ 30 kg.
1094633|NCT00576823|O2|Outcome|Alfuzosin Solution - 8-16 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow the tablets or preferred to take the solution or had a body weight < 30 kg.
1094634|NCT00576823|O1|Outcome|Alfuzosin Solution - 2-7 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age.
1094635|NCT00576823|E3|Reported Event|Afluzosin Tablets - 8-16 Years|Alfuzosin tablet, daily dose divided in 2 doses given at breakfast and dinner to children and adolescents 8-16 years of age who were able to swallow the tablets and had a body weight ≥ 30 kg.
1094636|NCT00576823|E2|Reported Event|Afluzosin Solution - 8-16 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow the tablets or preferred to take the solution or had a body weight < 30 kg.
1094637|NCT00576823|E1|Reported Event|Afluzosin Solution - 2-7 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age.
1094638|NCT00576758|B3|Baseline|Total|Total of all reporting groups
1094639|NCT00576758|B2|Baseline|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094640|NCT00576758|B1|Baseline|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094641|NCT00576758|P2|Participant Flow|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094642|NCT00576758|P1|Participant Flow|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094643|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094644|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094645|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094772|NCT00576472|B14|Baseline|Declined Home Maintenance Phase|Patients who completed the MPH Cross Over Phase but chose to decline participation in the Home Maintenance Phase.
1094646|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094647|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094648|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094649|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094650|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094651|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094703|NCT00576732|O3|Outcome|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
1094704|NCT00576732|O2|Outcome|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
1094652|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094653|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094654|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094655|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094656|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094657|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094658|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094659|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094734|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
1094660|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094661|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094662|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094663|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094664|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094665|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094666|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094667|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094668|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094669|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094670|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094671|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094672|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094673|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094735|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
1094674|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094675|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094676|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094677|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094678|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094679|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094680|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094681|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094682|NCT00576758|E2|Reported Event|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094683|NCT00576758|E1|Reported Event|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
1094684|NCT00576732|B4|Baseline|Total|Total of all reporting groups
1094685|NCT00576732|B3|Baseline|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
1094686|NCT00576732|B2|Baseline|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
1094687|NCT00576732|B1|Baseline|Placebo|Double-blind Period. Oral solution for 6 weeks.
1094688|NCT00576732|P6|Participant Flow|Ris High Dose/RIS|Open-label Period. Subjects in the double-blind risperidone high dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
1094689|NCT00576732|P5|Participant Flow|Ris Low Dose/RIS|Open-label Period. Subjects in the double-blind risperidone low dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
1094690|NCT00576732|P4|Participant Flow|Placebo/RIS|Open-label Period. Subjects in the double-blind placebo group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
1094691|NCT00576732|P3|Participant Flow|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
1094692|NCT00576732|P2|Participant Flow|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
1094693|NCT00576732|P1|Participant Flow|Placebo|Double-blind Period. Oral solution for 6 weeks.
1095865|NCT00573261|O2|Outcome|Pregabalin|Pregabalin
1094694|NCT00576732|O3|Outcome|Ris High Dose/RIS|Open-label Period. Subjects in the double-blind risperidone high dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
1094695|NCT00576732|O2|Outcome|Ris Low Dose/RIS|Open-label Period. Subjects in the double-blind risperidone low dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
1094696|NCT00576732|O1|Outcome|Placebo/RIS|Open-label Period. Subjects in the double-blind placebo group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
1094697|NCT00576732|O3|Outcome|Ris High Dose/RIS|Open-label Period. Subjects in the double-blind risperidone high dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
1094698|NCT00576732|O2|Outcome|Ris Low Dose/RIS|Open-label Period. Subjects in the double-blind risperidone low dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
1094699|NCT00576732|O1|Outcome|Placebo/RIS|Open-label Period. Subjects in the double-blind placebo group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
1094700|NCT00576732|O3|Outcome|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
1094701|NCT00576732|O2|Outcome|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
1094702|NCT00576732|O1|Outcome|Placebo|Double-blind Period. Oral solution for 6 weeks.
1095150|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
1094706|NCT00576732|O3|Outcome|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
1094707|NCT00576732|O2|Outcome|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
1094708|NCT00576732|O1|Outcome|Placebo|Double-blind Period. Oral solution for 6 weeks.
1094709|NCT00576732|O3|Outcome|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
1094710|NCT00576732|O2|Outcome|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
1094711|NCT00576732|O1|Outcome|Placebo|Double-blind Period. Oral solution for 6 weeks.
1094712|NCT00576732|O3|Outcome|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
1094713|NCT00576732|O2|Outcome|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
1094714|NCT00576732|O1|Outcome|Placebo|Double-blind Period. Oral solution for 6 weeks.
1094715|NCT00576732|O3|Outcome|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
1094716|NCT00576732|O2|Outcome|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
1094717|NCT00576732|O1|Outcome|Placebo|Double-blind Period. Oral solution for 6 weeks.
1094718|NCT00576732|E4|Reported Event|Open-label Risperidone|Subjects who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
1094719|NCT00576732|E3|Reported Event|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
1094720|NCT00576732|E2|Reported Event|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
1094721|NCT00576732|E1|Reported Event|Placebo|Double-blind Period. Oral solution for 6 weeks.
1094722|NCT00576693|B3|Baseline|Total|Total of all reporting groups
1094723|NCT00576693|B2|Baseline|Intensive Medical Management Alone|"Intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)~intensive medical management: intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)"
1094736|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
1095174|NCT00575588|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
1094724|NCT00576693|B1|Baseline|Intensive Medical Management Plus Stenting|"intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl).~intracranial angioplasty and stenting: intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardia"
1094725|NCT00576693|P2|Participant Flow|Intensive Medical Management Alone|"Intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)~intensive medical management: intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)"
1094726|NCT00576693|P1|Participant Flow|Intensive Medical Management Plus Stenting|"intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl).~intracranial angioplasty and stenting: intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardia"
1094727|NCT00576693|O2|Outcome|Intensive Medical Management Alone|"Intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)~intensive medical management: intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)"
1094728|NCT00576693|O1|Outcome|Intensive Medical Management Plus Stenting|"intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl).~intracranial angioplasty and stenting: intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardia"
1094729|NCT00576693|E2|Reported Event|Intensive Medical Management Alone|"Intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)~intensive medical management: intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)"
1094730|NCT00576693|E1|Reported Event|Intensive Medical Management Plus Stenting|"intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl).~intracranial angioplasty and stenting: intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardia"
1094731|NCT00576628|B1|Baseline|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
1094732|NCT00576628|P1|Participant Flow|C.E.R.A|Participants received methoxy polyethylene glycol-epoetin beta (Continuous Erythropoietin Receptor Activator [C.E.R.A]) subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 microgram per kilogram (mcg/kg) of C.E.R.A. Once the Hemoglobin (Hb) concentration was attained within the target range of 11.0 and 13.0 gram per deciliter (g/dL), the dose was adjusted to maintain the Hb concentration within the target range.
1094733|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
1094768|NCT00576524|E2|Reported Event|ITD Device|A group of subjects will be randomized to receive Impedance Threshold Device.
1094737|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
1094738|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
1094739|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
1094740|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
1094741|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
1094742|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
1094743|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
1094744|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
1094745|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range..
1094746|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
1094747|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
1094748|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
1094749|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
1094750|NCT00576628|E1|Reported Event|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
1094751|NCT00576576|B1|Baseline|Atorvastatin|"All patients in this arm are given atorvastatin therapy.~Atorvastatin : Atorvastatin 80 mg a day"
1094752|NCT00576576|P1|Participant Flow|Atorvastatin|"All patients in this arm are given atorvastatin therapy.~Atorvastatin : Atorvastatin 80 mg a day"
1094753|NCT00576576|O1|Outcome|Atorvastatin|"All patients in this arm are given atorvastatin therapy.~Atorvastatin : Atorvastatin 80 mg a day"
1094754|NCT00576576|O1|Outcome|Atorvastatin|"All patients in this arm are given atorvastatin therapy.~Atorvastatin : Atorvastatin 80 mg a day"
1094755|NCT00576576|O1|Outcome|Atorvastatin|"All patients in this arm are given atorvastatin therapy.~Atorvastatin : Atorvastatin 80 mg a day"
1094756|NCT00576576|E1|Reported Event|Atorvastatin|"All patients in this arm are given atorvastatin therapy.~Atorvastatin : Atorvastatin 80 mg a day"
1094757|NCT00576524|B3|Baseline|Total|Total of all reporting groups
1094758|NCT00576524|B2|Baseline|ITD Device|A group of subjects will be randomized to receive Impedance Threshold Device.
1094759|NCT00576524|B1|Baseline|Sham Device|A group of subjects will be randomized to receive the placebo sham device.
1094760|NCT00576524|P2|Participant Flow|Sham Device First, ITD Next|A group of subjects will be randomized to receive sham first, followed by ITD 7 days later.
1094761|NCT00576524|P1|Participant Flow|ITD First, Sham Device Next|A group of subjects will be randomized to receive the ITD first, followed by sham 7 days later.
1094762|NCT00576524|O2|Outcome|ITD Device|A group of subjects will be randomized to receive Impedance Threshold Device.
1094763|NCT00576524|O1|Outcome|Sham Device|A group of subjects will be randomized to receive the placebo sham device.
1094764|NCT00576524|O2|Outcome|ITD First, Sham Device Next|A group of subjects will be randomized to receive ITD, followed by sham device 7 days later.
1094765|NCT00576524|O1|Outcome|Sham Device First, ITD Next|A group of subjects will be randomized to receive the sham device, follwed by ITD 7 days later.
1094766|NCT00576524|O2|Outcome|ITD First, Sham Device Next|A group of subjects will be randomized to receive ITD, followed by sham device after 7 days.
1094767|NCT00576524|O1|Outcome|Sham Device First, ITD Next|A group of subjects will be randomized to receive the sham device, followed by ITD next after 7 days.
1094773|NCT00576472|B13|Baseline|Moderate Dose/Placebo/Low Dose (MPL)|The MPL group received a moderate dose of Methylphenidate (MPH) on week one, a placebo on week two, and a low dose of Methylphenidate (MPH) on week three.
1094774|NCT00576472|B12|Baseline|Moderate Dose/Low Dose/Placebo (MLP)|The MLP group received a moderate dose of Methylphenidate (MPH) on week one, a low dose of Methylphenidate (MPH) on week two, and a placebo on week three.
1094775|NCT00576472|B11|Baseline|Low Dose/Placebo/Moderate Dose (LPM)|The LPM group received a low dose of Methylphenidate (MPH) on week one, a placebo on week two, and a moderate dose of Methylphenidate (MPH) on week three.
1094776|NCT00576472|B10|Baseline|Low Dose/Moderate Dose/ Placebo (LMP)|The LMP group received a low dose of Methylphenidate (MPH) on week one, a moderate dose of Methylphenidate (MPH) on week two, and a placebo on week three.
1094777|NCT00576472|B9|Baseline|Placebo/Moderate Dose/Low Dose (PML)|The PML group received a placebo on week one, moderate dose Methylphenidate (MPH) on week two, and a lose dose of Methylphenidate (MPH) on week three.
1094778|NCT00576472|B8|Baseline|Placebo/Low Dose/Moderate Dose (PLM)|The PLM group received a placebo on week one, low dose Methylphenidate (MPH) on week two, and a moderate dose of Methylphenidate (MPH) on week three.
1094779|NCT00576472|B7|Baseline|Not Randomized-Cross Over|Patients who completed the MPH in Lab Phase but were not randomized for the MPH Cross Over Phase
1094780|NCT00576472|B6|Baseline|Group P/M|Group P/M (patients receive oral placebo and ten Methylphenidate (MPH))
1094781|NCT00576472|B5|Baseline|Group M/P|Group M/P (patients receive oral Methylphenidate (MPH) and then an oral placebo)
1094782|NCT00576472|B4|Baseline|Not Randomized-In Lab Phase|Patients not randomized for the MPH in Lab Phase
1094783|NCT00576472|B3|Baseline|High|Intensity of prior Central Nervous System radiation therapy was considered high.
1094784|NCT00576472|B2|Baseline|Moderate|Intensity of prior Central Nervous System radiation therapy was considered moderate.
1094785|NCT00576472|B1|Baseline|Mild|Intensity of prior Central Nervous System radiation therapy was considered mild.
1094786|NCT00576472|P15|Participant Flow|Methylphenidate (MPH) Home Maintenance Phase|Methylphenidate (MPH) was administered for 12 months during the Methylphenidate (MPH) Home Maintenance Phase.
1094787|NCT00576472|P14|Participant Flow|Declined Methylphenidate (MPH) Home Maintenance Phase|Patients who completed the Methylphenidate (MPH) Cross Over Phase but chose to decline participation in the Methylphenidate (MPH) Home Maintenance Phase.
1094788|NCT00576472|P13|Participant Flow|Moderate Dose/Placebo/Low Dose (MPL)|The MPL group received a moderate dose of Methylphenidate (MPH) on week one, a placebo on week two, and a low dose of Methylphenidate (MPH) on week three.
1094789|NCT00576472|P12|Participant Flow|Moderate Dose/Low Dose/Placebo (MLP)|The MLP group received a moderate dose of Methylphenidate (MPH) on week one, a low dose of Methylphenidate (MPH) on week two, and a placebo on week three.
1094910|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
1094790|NCT00576472|P11|Participant Flow|Low Dose/Placebo/Moderate Dose (LPM)|The LPM group received a low dose of Methylphenidate (MPH) on week one, a placebo on week two, and a moderate dose of Methylphenidate (MPH) on week three.
1094791|NCT00576472|P10|Participant Flow|Low Dose/Moderate Dose/ Placebo (LMP)|The LMP group received a low dose of Methylphenidate (MPH) on week one, a moderate dose of Methylphenidate (MPH) on week two, and a placebo on week three.
1094792|NCT00576472|P9|Participant Flow|Placebo/Moderate Dose/Low Dose (PML)|The PML group received a placebo on week one, moderate dose Methylphenidate (MPH) on week two, and a low dose of Methylphenidate (MPH) on week three.
1094793|NCT00576472|P8|Participant Flow|Placebo/Low Dose/Moderate Dose (PLM)|The PLM group received a placebo on week one, low dose Methylphenidate (MPH) on week two, and a moderate dose of Methylphenidate (MPH) on week three.
1094794|NCT00576472|P7|Participant Flow|Completed MPH In-Lab Phase/Not Randomized for Cross Over Phase|Patients who completed the MPH in Lab Phase but were not randomized for the MPH Cross-Over Phase
1094795|NCT00576472|P6|Participant Flow|Group P/M|Group P/M (patients received oral placebo and then Methylphenidate (MPH))
1094796|NCT00576472|P5|Participant Flow|Group M/P|Group M/P (patients received oral Methylphenidate (MPH) and then an oral placebo)
1094797|NCT00576472|P4|Participant Flow|Screened/Didn't Qualify for Methylphenidate (MPH) In-Lab Phase|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase.
1094798|NCT00576472|P3|Participant Flow|High Intensity|Intensity of prior CNS Therapy (>24 Gy CRT with or without systemic and/or intrathecal chemotherapy) classified as high.
1094799|NCT00576472|P2|Participant Flow|Moderate Intensity|Intensity of prior CNS Therapy (< 24 Gy CRT with or without systemic and/or intrathecal chemotherapy)classified as moderate.
1094800|NCT00576472|P1|Participant Flow|Mild Intensity|Intensity of prior CNS Therapy (systemic and/or intrathecal chemotherapy only)classified as mild.
1094801|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094802|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094877|NCT00576472|O1|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 55 were screened at the beginning of the trial using the CTRS: ADHD T Questionnaire and 59 were screen at completion. 47 patients were screened at both the beginning and end of the home maintenance phase.
1094878|NCT00576472|O4|Outcome|High Treatment Intensity|High intensity central nervous system therapy (>24 Gy CRT with or without systemic and/or intrathecal chemotherapy.
1094803|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094804|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094805|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094806|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094807|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094911|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
1094914|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
1094915|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
1094808|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094809|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094810|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094811|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094812|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094813|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094814|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094879|NCT00576472|O3|Outcome|Moderate Treatment Intensity|Moderately intense central nervous system therapy (<= 24 Gy CRT with or without systemic and/or intrathecal chemotherapy).
1095866|NCT00573261|O1|Outcome|Placebo|Placebo
1094815|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094816|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094817|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094818|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094819|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094820|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094821|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094822|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094823|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094824|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094825|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094826|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094880|NCT00576472|O2|Outcome|Mild Treatment Intensity|Mildly intense central nervous system therapy (systemic and/or intrathecal chemotherapy only)
1094881|NCT00576472|O1|Outcome|Siblings|The sibling control group received no radiation therapy.
1094827|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094828|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094829|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094830|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094831|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094832|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094833|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094834|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094835|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094836|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
1094837|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
1094838|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
1094882|NCT00576472|O2|Outcome|Patients With Brain Tumors|Patients with brain tumors who had evaluable MRIs.
1095933|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
1094839|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
1094840|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
1094841|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
1094842|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
1094912|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
1094913|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
1094843|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
1094844|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
1094845|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
1094846|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
1094847|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
1094848|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
1094849|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
1094883|NCT00576472|O1|Outcome|Patients With ALL|Patients with Acute Lymphoblastic Leukemia (ALL) who had evaluable MRIs.
1094884|NCT00576472|O2|Outcome|Siblings|Sibling controls with evaluable MRIs.
1094885|NCT00576472|O1|Outcome|Patients|Patients with evaluable MRIs.
1094886|NCT00576472|E3|Reported Event|High|Intensity of prior Central Nervous System radiation therapy was considered high.
1094887|NCT00576472|E2|Reported Event|Moderate|Intensity of prior Central Nervous System radiation therapy was considered moderate.
1094850|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
1094851|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
1094852|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
1094853|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
1094854|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
1094855|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
1094856|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
1094857|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
1094858|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
1094859|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
1094860|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
1094888|NCT00576472|E1|Reported Event|Mild|Intensity of prior Central Nervous System radiation therapy was considered mild.
1094889|NCT00576420|B4|Baseline|Total|Total of all reporting groups
1094890|NCT00576420|B3|Baseline|Control Group|Manual compression with surgical gauze pads.
1094891|NCT00576420|B2|Baseline|FS VH S/D 500 S-apr - 120 Seconds|FS VH S/D 500 s-apr, 120 - seconds polymerization time
1094892|NCT00576420|B1|Baseline|FS VH S/D 500 S-apr - 60 Seconds|FS VH S/D 500 s-apr, 60 - seconds polymerization time
1094861|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
1094862|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
1094863|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
1094864|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
1094865|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
1094866|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
1094867|NCT00576472|O3|Outcome|Moderate Dose|Patients assigned to the Moderate Dose group were randomly assigned to receive one of two arms: Group MLP received moderate dose during week one, low dose during week 2, and placebo during week 3; Group MPL received moderate dose during week one, placebo during week 2, and low dose during week 3.
1094868|NCT00576472|O2|Outcome|Low Dose|Patients assigned to the Low Dose group were randomly assigned to receive one of two arms: Group LMP received low dose during week one, moderate dose during week 2, and placebo during week 3; Group LPM received low dose during week one, placebo during week 2, and moderate dose during week 3.
1094869|NCT00576472|O1|Outcome|Placebo|Patients assigned to the placebo group were randomly assigned to receive one of two arms: Group PLM received placebo during week one, low dose during week 2, and moderate dose during week 3; Group PML received placebo during week one, moderate dose during week 2, and low dose during week 3.
1094870|NCT00576472|O1|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the WIAT Math: Composite Standard Score System and 68 were screened at completion. 68 patients were screened at both the beginning and end of the home maintenance phase.
1094871|NCT00576472|O1|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the WIAT Spelling: Standard Score System and 68 were screened at completion. 68 patients were screened at both the beginning and end of the home maintenance phase.
1094872|NCT00576472|O1|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the WIAT Reading: Composite Standard Score System and 68 were screened at completion. 68 patients were screened at both the beginning and end of the home maintenance phase.
1094873|NCT00576472|O1|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the Social Skills Rating System and 68 were screened at completion. 68 patients were screened at both the beginning and end of the home maintenance phase.
1094874|NCT00576472|O1|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the CPRS: Cognitive Problem T Questionnaire and 68 were screen at completion. 68 patients were screened at both the beginning and end of the home maintenance phase.
1094875|NCT00576472|O1|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the CPRS: ADHD T Questionnaire and 68 were screen at completion. 68 patients were screened at both the beginning and end of the home maintenance phase.
1094876|NCT00576472|O1|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 55 were screened at the beginning of the trial using the CTRS: Cognitive Problem T Score Questionnaire and 59 were screen at completion. 47 patients were screened at both the beginning and end of the home maintenance phase.
1094893|NCT00576420|P3|Participant Flow|Control Group|Manual compression with surgical gauze pads.
1094894|NCT00576420|P2|Participant Flow|FS VH S/D 500 S-apr - 120 Seconds|FS VH S/D 500 s-apr, 120 - seconds polymerization time
1094895|NCT00576420|P1|Participant Flow|FS VH S/D 500 S-apr - 60 Seconds|Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60 - seconds polymerization time
1094896|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
1094897|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
1094898|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-seconds polymerization time
1094899|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
1094900|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
1094901|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
1094902|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
1094903|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
1094904|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
1094905|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
1094906|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
1094907|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
1094908|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
1094916|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
1094917|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
1094918|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
1094919|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
1094920|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
1094921|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
1094922|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
1094923|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
1094924|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
1094925|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
1094926|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
1094927|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
1094928|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
1094929|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
1094930|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
1094931|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
1094932|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
1094933|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
1094934|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
1094935|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
1095013|NCT00576420|O6|Outcome|FS 120: Preoperative Baseline - Postoperative Day 1|FS VH S/D 500 s-apr, 120-seconds polymerization
1095934|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
1094936|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
1094937|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
1094938|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
1094939|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
1094940|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
1094941|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
1094942|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
1094943|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
1094944|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
1094945|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
1094946|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
1094947|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
1094948|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
1094949|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
1094950|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
1094951|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
1094952|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
1094953|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
1094954|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
1094955|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
1094956|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
1094957|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
1094958|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
1094959|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
1094960|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
1094961|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
1094962|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
1094963|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
1094964|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
1094965|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
1094966|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
1094967|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
1094968|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
1094969|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
1094970|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
1094971|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
1094972|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
1094973|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
1094974|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
1094975|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
1095014|NCT00576420|O5|Outcome|FS 60: Preoperative Baseline - Postoperative Day 1|FS VH S/D 500 s-apr, 60-seconds polymerization
1095015|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline - Intraoperative Day 0|Manual compression with surgical gauze pads
1094976|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
1094977|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
1094978|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
1094979|NCT00576420|O8|Outcome|Control Group: Preoperative Baseline - Postoperative Day 14|Manual compression with surgical gauze pads
1094980|NCT00576420|O7|Outcome|FS All: Preoperative Baseline - Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
1094981|NCT00576420|O6|Outcome|FS 120: Preoperative Baseline - Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
1094982|NCT00576420|O5|Outcome|FS 60: Preoperative Baseline - Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
1094983|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline - Postoperative Day 1|Manual compression with surgical gauze pads
1094984|NCT00576420|O3|Outcome|FS All: Preoperative Baseline - Postoperative Day 1|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
1094985|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline - Postoperative Day 1|FS VH S/D 500 s-apr, 120-seconds polymerization
1094986|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline - Postoperative Day 1|FS VH S/D 500 s-apr, 60-seconds polymerization
1094987|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
1094988|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds polymerization time):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
1094989|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
1094990|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
1094991|NCT00576420|O12|Outcome|Control Group: Preoperative Baseline - Postoperative Day 14|Manual compression with surgical gauze pads
1094992|NCT00576420|O11|Outcome|FS All: Preoperative Baseline - Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
1094993|NCT00576420|O10|Outcome|FS 120: Preoperative Baseline - Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
1094994|NCT00576420|O9|Outcome|FS 60: Preoperative Baseline - Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
1094995|NCT00576420|O8|Outcome|Control Group: Preoperative Baseline - Postoperative Day 1|Manual compression with surgical gauze pads
1094996|NCT00576420|O7|Outcome|FS All: Preoperative Baseline - Postoperative Day 1|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
1094997|NCT00576420|O6|Outcome|FS 120: Preoperative Baseline - Postoperative Day 1|FS VH S/D 500 s-apr, 120-seconds polymerization
1094998|NCT00576420|O5|Outcome|FS 60: Preoperative Baseline - Postoperative Day 1|FS VH S/D 500 s-apr, 60-seconds polymerization
1094999|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline - Intraoperative Day 0|Manual compression with surgical gauze pads
1095000|NCT00576420|O3|Outcome|FS All: Preoperative Baseline - Intraoperative Day 0|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
1095001|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline - Intraoperative Day 0|FS VH S/D 500 s-apr, 120-seconds polymerization
1095002|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline - Intraoperative Day 0|FS VH S/D 500 s-apr, 60-seconds polymerization
1095003|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
1095004|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds polymerization time):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
1095005|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
1095006|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
1095007|NCT00576420|O12|Outcome|Control Group: Preoperative Baseline - Postoperative Day 14|Manual compression with surgical gauze pads
1095008|NCT00576420|O11|Outcome|FS All: Preoperative Baseline - Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
1095009|NCT00576420|O10|Outcome|FS 120: Preoperative Baseline - Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
1095010|NCT00576420|O9|Outcome|FS 60: Preoperative Baseline - Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
1095011|NCT00576420|O8|Outcome|Control Group: Preoperative Baseline - Postoperative Day 1|Manual compression with surgical gauze pads
1095012|NCT00576420|O7|Outcome|FS All: Preoperative Baseline - Postoperative Day 1|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
1095016|NCT00576420|O3|Outcome|FS All: Preoperative Baseline - Intraoperative Day 0|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
1095017|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline - Intraoperative Day 0|FS VH S/D 500 s-apr, 120-seconds polymerization
1095018|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline - Intraoperative Day 0|FS VH S/D 500 s-apr (FS), 60-seconds polymerization
1095019|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
1095020|NCT00576420|O3|Outcome|FS VH S/D 500 S-apr - All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds polymerization time) (FS All):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
1095021|NCT00576420|O2|Outcome|FS VH S/D 500 S -Apr - 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization (FS 120)
1095022|NCT00576420|O1|Outcome|FS VH S/D 500 S -Apr - 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization (FS 60)
1095023|NCT00576420|O4|Outcome|Control Group|Manual compression with surgical gauze pads
1095024|NCT00576420|O3|Outcome|FS VH S/D 500 S-apr All - (60 + 120 Seconds)|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
1095025|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
1095026|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-seconds polymerization time
1095027|NCT00576420|O4|Outcome|Control Group|Manual compression with surgical gauze pads
1095028|NCT00576420|O3|Outcome|FS VH S/D 500 S-apr - All - (60 + 120 Seconds)|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
1095029|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
1095030|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-Seconds polymerization time
1095031|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
1095032|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
1095033|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-seconds polymerization time
1095034|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
1095035|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization.
1095142|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
1095036|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
1095037|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
1095038|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
1095039|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-seconds polymerization time
1095040|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
1095041|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
1095042|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-seconds polymerization time
1095043|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
1095044|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
1095045|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-seconds polymerization time
1095046|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
1095047|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
1095048|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-seconds polymerization time
1095049|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
1095050|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
1095051|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-seconds polymerization time
1095052|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
1095053|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
1095054|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr- 60-Seconds|Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
1095055|NCT00576420|E4|Reported Event|Control Group|Treatment of the study-suture line will be manual compression with surgical gauze pads.
1095056|NCT00576420|E3|Reported Event|Fibrin Sealant All - (60 + 120 Seconds)|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60 seconds polymerization time~FS VH S/D 500 s-apr, 120 seconds polymerization time"
1095057|NCT00576420|E2|Reported Event|Fibrin Sealant - 120 Seconds|FS VH S/D 500 s-apr, 120 seconds polymerization time
1095058|NCT00576420|E1|Reported Event|Fibrin Sealant - 60 Seconds|Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60 seconds polymerization time
1095059|NCT00576381|B1|Baseline|Dosing Cohorts|"Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infuusion for up to 24 hours post cardiac surgery.~Dexmedetomidine : Dosage Level 1=0.25mcg/kg loading dose, 0.2 mcg/kg/hr infusion Dosage Level 1A= 0.35mcg/kg loading dose, 0.3 mcg/kg/hr infusion Dosage Level 2= 0.5mcg/kg loading dose, 0.4 mcg/kg/hr infusion"
1097474|NCT00568061|B3|Baseline|Total|Total of all reporting groups
1095060|NCT00576381|P1|Participant Flow|Neonatal Dose Escalation Cohorts|"Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours post cardiac surgery.~Cohort 1--0.25 mcg/kg loading dose, 0.2 mcg/kg/hr infusion Cohort 1A--0.35 mcg/kg loading dose, 0.3 mcg/kg/hr infusion Cohort 2--0.5 mcg/kg loading dose, 0.4 mcg/kg/hr infusion"
1095061|NCT00576381|O1|Outcome|Neonates|"Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infuusion for up to 24 hours post cardiac surgery.~Cohort 1--0.25mcg/kg loading dose, 0.2mcg/kg/hr infusion Cohort 1A--0.35 mcg/kg loading dose, 0.3 mcg/kg/hr infusion Cohort 2--0.5 mcg/kg loading dose, 0.4 mcg/kg/hr infusion"
1095062|NCT00576381|E1|Reported Event|Dosing Cohorts|"Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infuusion for up to 24 hours post cardiac surgery.~Dexmedetomidine : Dosage Level 1=0.25mcg/kg loading dose, 0.2 mcg/kg/hr infusion Dosage Level 1A= 0.35mcg/kg loading dose, 0.3 mcg/kg/hr infusion Dosage Level 2= 0.5mcg/kg loading dose, 0.4 mcg/kg/hr infusion"
1095063|NCT00576316|B1|Baseline|Symbicort 160/4.5 Turbuhaler|Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
1095064|NCT00576316|P1|Participant Flow|Symbicort 160/4.5 Turbuhaler|Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
1095065|NCT00576316|O1|Outcome|Symbicort 160/4.5 Turbuhaler|Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
1095066|NCT00576316|O1|Outcome|Symbicort 160/4.5 Turbuhaler|Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
1095067|NCT00576316|E1|Reported Event|Symbicort 160/4.5 Turbuhaler|Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
1095068|NCT00576303|B1|Baseline|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
1095069|NCT00576303|P1|Participant Flow|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (Continuous Erythropoietin Receptor Activator [C.E.R.A]) intravenously, at a dose of 120, 200 or 360 microgram (µg) every four weeks. The dose of C.E.R.A was based on the erythropoiesis stimulating agents (ESA) like epoetin alfa or beta dose of<8000, 8000-16000, or >16000 international units (IU)/week, administered during the stability verification period (SVP) of 4 weeks. The SVP period was followed by dose titration period (DTP) of 16 weeks, efficacy evaluation period (EEP) of 8 weeks and long term safety period (LTSP) of 28 weeks
1095070|NCT00576303|O1|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
1095198|NCT00575380|O2|Outcome|Vigamox|
1095071|NCT00576303|O1|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
1095072|NCT00576303|O1|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
1095073|NCT00576303|O1|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
1095074|NCT00576303|O1|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
1095075|NCT00576303|O1|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
1095076|NCT00576303|E1|Reported Event|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
1095077|NCT00576251|B3|Baseline|Total|Total of all reporting groups
1095078|NCT00576251|B2|Baseline|TOBRADEX Ophthalmic Suspension|TOBRADEX Ophthalmic Suspension
1095079|NCT00576251|B1|Baseline|Tobramycin 0.3%/Dexamethasone 0.05%|Tobramycin 0.3%/Dexamethasone 0.05%
1095080|NCT00576251|P2|Participant Flow|TOBRADEX Ophthalmic Suspension|TOBRADEX Ophthalmic Suspension
1095081|NCT00576251|P1|Participant Flow|Tobramycin 0.3%/Dexamethasone 0.05%|Tobramycin 0.3%/Dexamethasone 0.05%
1095082|NCT00576251|O2|Outcome|TOBRADEX Ophthalmic Suspension|TOBRADEX Ophthalmic Suspension
1095083|NCT00576251|O1|Outcome|Tobramycin 0.3%/Dexamethasone 0.05%|Tobramycin 0.3%/Dexamethasone 0.05%
1095084|NCT00576251|E2|Reported Event|TOBRADEX Ophthalmic Suspension|TOBRADEX Ophthalmic Suspension
1095085|NCT00576251|E1|Reported Event|Tobramycin 0.3%/Dexamethasone 0.05%|Tobramycin 0.3%/Dexamethasone 0.05%
1095086|NCT00576199|B1|Baseline|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
1095111|NCT00575887|O1|Outcome|Temozolomide|"Temozolomide : 100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles.~Number of cycles: Until progression or unacceptable toxicity"
1095087|NCT00576199|P1|Participant Flow|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
1095088|NCT00576199|O1|Outcome|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
1095089|NCT00576199|O1|Outcome|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
1095090|NCT00576199|O1|Outcome|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
1095091|NCT00576199|O1|Outcome|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
1095092|NCT00576199|O1|Outcome|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
1095093|NCT00576199|O1|Outcome|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
1095094|NCT00576199|E1|Reported Event|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
1095095|NCT00576147|B1|Baseline|CT Scan|The standard head CT done to head trauma patients
1095096|NCT00576147|P1|Participant Flow|CT Scan|The standard head CT done to head trauma patients
1095097|NCT00576147|O1|Outcome|CT Scan|The standard head CT done to head trauma patients
1095098|NCT00576147|E1|Reported Event|CT Scan|The standard head CT done to head trauma patients
1095143|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
1095144|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
1095145|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
1095146|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
1095147|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
1095148|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
1095199|NCT00575380|O1|Outcome|Azasite|
1095099|NCT00576056|B1|Baseline|Tace + Sorafenib|"Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.~TACE + Sorafenib: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination."
1095100|NCT00576056|P1|Participant Flow|Tace + Sorafenib|"Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.~TACE + Sorafenib: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination."
1095101|NCT00576056|O1|Outcome|Tace + Sorafenib|"Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.~TACE + Sorafenib: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination."
1095102|NCT00576056|O1|Outcome|Tace + Sorafenib|"Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.~TACE + Sorafenib: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination."
1095103|NCT00576056|E1|Reported Event|Tace + Sorafenib|"Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.~TACE + Sorafenib: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination."
1095104|NCT00575965|B1|Baseline|Simvastatin|Single arm, phase II study. All 18 patients received study drug.
1095105|NCT00575965|P1|Participant Flow|Simvastatin|Single arm, phase II study. All 18 patients received study drug.
1095106|NCT00575965|O1|Outcome|Simvastatin|Simvastatin at 20 mg daily for the first week, then dose escalated weekly by 20 mg a day to a maximum of 80 mg daily by week 4. Patients were maintained on therapy until progression or up to 2 years.
1095107|NCT00575965|O1|Outcome|Simvastatin|Simvastatin at 20 mg daily for the first week, then dose escalated weekly by 20 mg a day to a maximum of 80 mg daily by week 4. Patients were maintained on therapy until progression or up to 2 years.
1095108|NCT00575965|E1|Reported Event|Simvastatin|Simvastatin at 20 mg daily for the first week, then dose escalated weekly by 20 mg a day to a maximum of 80 mg daily by week 4. Patients were maintained on therapy until progression or up to 2 years.
1095109|NCT00575887|B1|Baseline|Dose-Dense Temozolomide|"Temozolomide : 100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles.~Number of cycles: Until progression or unacceptable toxicity"
1095110|NCT00575887|P1|Participant Flow|Dose-Dense Temozolomide|"Temozolomide : 100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles.~Number of cycles: Until progression or unacceptable toxicity"
1095112|NCT00575887|E1|Reported Event|Temozolomide|"Temozolomide : 100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles.~Number of cycles: Until progression or unacceptable toxicity"
1095113|NCT00575666|B3|Baseline|Total|Total of all reporting groups
1095114|NCT00575666|B2|Baseline|Intervention: Placebo|Placebo group, daily dosage 160 IU placebo for 8 weeks with 4 week follow-up
1095115|NCT00575666|B1|Baseline|Intervention: Insulin|Intranasal insulin treatment, daily dosage 160 IU insulin for 8 weeks with a 4 week follow-up
1095116|NCT00575666|P2|Participant Flow|Intervention: Placebo|Placebo group, daily dosage 160 IU placebo for 8 weeks with 4 week follow-up
1095117|NCT00575666|P1|Participant Flow|Intervention: Insulin|Intranasal insulin treatment, daily dosage 160 IU insulin for 8 weeks with a 4 week follow-up
1095118|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
1095119|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
1095120|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
1095121|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
1095122|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
1095123|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
1095124|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
1095125|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
1095126|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
1095127|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
1095128|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
1095129|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
1095130|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
1095131|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
1095132|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
1095133|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
1095134|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
1095135|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
1095136|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
1095137|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
1095138|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
1095139|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
1095140|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
1095141|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
1095151|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
1095152|NCT00575666|E2|Reported Event|Intervention: Placebo|Placebo group, daily dosage 160 IU placebo for 8 weeks with 4 week follow-up
1095153|NCT00575666|E1|Reported Event|Intervention: Insulin|Intranasal insulin treatment, daily dosage 160 IU insulin for 8 weeks with a 4 week follow-up
1095154|NCT00575588|B3|Baseline|Total|Total of all reporting groups
1095155|NCT00575588|B2|Baseline|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
1095156|NCT00575588|B1|Baseline|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
1095157|NCT00575588|P2|Participant Flow|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
1095158|NCT00575588|P1|Participant Flow|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
1095159|NCT00575588|O2|Outcome|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
1095160|NCT00575588|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
1095161|NCT00575588|O2|Outcome|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
1095162|NCT00575588|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
1095163|NCT00575588|O2|Outcome|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
1095164|NCT00575588|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
1095165|NCT00575588|O2|Outcome|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
1095166|NCT00575588|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
1095167|NCT00575588|O2|Outcome|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
1095168|NCT00575588|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
1095169|NCT00575588|O2|Outcome|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
1095170|NCT00575588|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
1095171|NCT00575588|O2|Outcome|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
1095172|NCT00575588|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
1095173|NCT00575588|O2|Outcome|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
1097586|NCT00567840|B6|Baseline|Total|Total of all reporting groups
1095175|NCT00575588|E2|Reported Event|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
1095176|NCT00575588|E1|Reported Event|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
1095177|NCT00575510|B4|Baseline|Total|Total of all reporting groups
1095178|NCT00575510|B3|Baseline|Standard Care Only|Clinical standard of care at time of study
1095179|NCT00575510|B2|Baseline|Active Control|nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
1095180|NCT00575510|B1|Baseline|Intervention|Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
1095181|NCT00575510|P3|Participant Flow|Standard Care Only|Clinical standard of care at time of study
1095182|NCT00575510|P2|Participant Flow|Active Control|nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
1095183|NCT00575510|P1|Participant Flow|Intervention|Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
1095184|NCT00575510|O3|Outcome|Standard Care Only|Clinical standard of care at time of study
1095185|NCT00575510|O2|Outcome|Active Control|"non-targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling~Active control: Partial intervention (full intervention minus cultural-specific component)"
1095186|NCT00575510|O1|Outcome|Intervention|"Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling~Intervention: Multiple component intervention based in the unified theory of behavior"
1095187|NCT00575510|O3|Outcome|Standard Care Only|Clinical standard of care at time of study
1095188|NCT00575510|O2|Outcome|Active Control|"nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling~Active control: Partial intervention (full intervention minus cultural-specific component)"
1095189|NCT00575510|O1|Outcome|Intervention|"Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling~Intervention: Multiple component intervention based in the unified theory of behavior"
1095190|NCT00575510|E3|Reported Event|Standard Care Only|Clinical standard of care at time of study
1095191|NCT00575510|E2|Reported Event|Active Control|"nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling~Active control: Partial intervention (full intervention minus cultural-specific component)"
1095192|NCT00575510|E1|Reported Event|Intervention|"Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling~Intervention: Multiple component intervention based in the unified theory of behavior"
1095193|NCT00575380|B3|Baseline|Total|Total of all reporting groups
1095194|NCT00575380|B2|Baseline|Vigamox|
1095195|NCT00575380|B1|Baseline|Azasite|
1095196|NCT00575380|P2|Participant Flow|Vigamox|
1095197|NCT00575380|P1|Participant Flow|Azasite|
1095202|NCT00575380|E2|Reported Event|Vigamox|
1095203|NCT00575380|E1|Reported Event|Azasite|
1095204|NCT00575367|B3|Baseline|Total|Total of all reporting groups
1095205|NCT00575367|B2|Baseline|Vigamox|
1095206|NCT00575367|B1|Baseline|AzaSite|
1095207|NCT00575367|P2|Participant Flow|Vigamox|
1095208|NCT00575367|P1|Participant Flow|AzaSite|
1095209|NCT00575367|O2|Outcome|Vigamox|
1095210|NCT00575367|O1|Outcome|AzaSite|
1095211|NCT00575367|E2|Reported Event|Vigamox|
1095212|NCT00575367|E1|Reported Event|AzaSite|
1095213|NCT00575185|B3|Baseline|Total|Total of all reporting groups
1095214|NCT00575185|B2|Baseline|Placebo|"placebo 2 tablets twice daily for 21 days~placebo : Placebo tablets orally twice daily for 21 days."
1095215|NCT00575185|B1|Baseline|Valomaciclovir|"Valomaciclovir 2 grams orally twice daily for 21 days~Valomaciclovir : 4 grams orally of valomaciclovir (2 grams BID) for 21 days."
1095216|NCT00575185|P2|Participant Flow|Placebo|"placebo 2 tablets twice daily for 21 days~placebo : Placebo tablets orally twice daily for 21 days."
1095217|NCT00575185|P1|Participant Flow|Valomaciclovir|"Valomaciclovir 2 grams orally twice daily for 21 days~Valomaciclovir : 4 grams orally of valomaciclovir (2 grams BID) for 21 days."
1095218|NCT00575185|O2|Outcome|Placebo|"placebo 2 tablets twice daily for 21 days~placebo: Placebo tablets orally twice daily for 21 days."
1095219|NCT00575185|O1|Outcome|Valomaciclovir|"Valomaciclovir 2 grams orally twice daily for 21 days~Valomaciclovir: 4 grams orally of valomaciclovir (2 grams BID) for 21 days."
1095220|NCT00575185|O2|Outcome|Placebo|"placebo 2 tablets twice daily for 21 days~placebo : Placebo tablets orally twice daily for 21 days."
1095221|NCT00575185|O1|Outcome|Valomaciclovir|"Valomaciclovir 2 grams orally twice daily for 21 days~Valomaciclovir : 4 grams orally of valomaciclovir (2 grams BID) for 21 days."
1095222|NCT00575185|E2|Reported Event|Placebo|"placebo 2 tablets twice daily for 21 days~placebo : Placebo tablets orally twice daily for 21 days."
1095223|NCT00575185|E1|Reported Event|Valomaciclovir|"Valomaciclovir 2 grams orally twice daily for 21 days~Valomaciclovir : 4 grams orally of valomaciclovir (2 grams BID) for 21 days."
1095224|NCT00575146|B1|Baseline|Ketogenic Diet|ketogenic diet
1095225|NCT00575146|P1|Participant Flow|Ketogenic Diet|unrestricted ketogenic diet (< 50-60 g carbohydrates per day) and dietary supplementary products provided by Tavarlin
1095226|NCT00575146|O1|Outcome|Ketogenic Diet|unrestricted ketogenic diet
1095227|NCT00575146|O1|Outcome|Ketogenic Diet|unrestricted ketogenic diet
1095228|NCT00575146|O1|Outcome|Ketogenic Diet|unrestricted ketogenic diet
1095229|NCT00575146|E1|Reported Event|Ketogenic Diet|ketogenic diet
1095230|NCT00575094|B1|Baseline|Tigecycline|Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator.
1096081|NCT00572897|O1|Outcome|Sibling Donor|Patients received a stem cell transplant from sibling
1095231|NCT00575094|P1|Participant Flow|Tigecycline|Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator.
1095232|NCT00575094|O1|Outcome|Tigecycline|Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator.
1095233|NCT00575094|E1|Reported Event|Tigecycline|Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator.
1095234|NCT00575042|B1|Baseline|Patients Treated With Fenofibrate|
1095235|NCT00575042|P1|Participant Flow|Patients Treated With Fenofibrate|
1095236|NCT00575042|O2|Outcome|Post Treatment|
1095237|NCT00575042|O1|Outcome|Pre Treatment|
1095238|NCT00575042|E1|Reported Event|Patients Treated With Fenofibrate|
1095239|NCT00575029|B1|Baseline|Megestrol Acetate|Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
1095240|NCT00575029|P1|Participant Flow|Megestrol Acetate|Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
1095241|NCT00575029|O1|Outcome|Megestrol Acetate|Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
1095242|NCT00575029|O1|Outcome|Megestrol Acetate|Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
1095243|NCT00575029|E1|Reported Event|Megestrol Acetate|Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
1095244|NCT00575016|B5|Baseline|Total|Total of all reporting groups
1095245|NCT00575016|B4|Baseline|Placebo|Normal saline (placebo)
1095246|NCT00575016|B3|Baseline|Botulinum Toxin Type A (50U)|botulinum toxin Type A (50U)
1095247|NCT00575016|B2|Baseline|Botulinum Toxin Type A (100U)|botulinum toxin Type A (100U)
1095248|NCT00575016|B1|Baseline|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
1095249|NCT00575016|P4|Participant Flow|Placebo|Normal saline (placebo)
1095250|NCT00575016|P3|Participant Flow|Botulinum Toxin Type A (50U)|botulinum toxin Type A (50U)
1095251|NCT00575016|P2|Participant Flow|Botulinum Toxin Type A (100U)|botulinum toxin Type A (100U)
1095252|NCT00575016|P1|Participant Flow|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
1095253|NCT00575016|O4|Outcome|Placebo|Normal saline (placebo)
1095254|NCT00575016|O3|Outcome|Botulinum Toxin Type A (50U)|botulinum toxin Type A (50U)
1095255|NCT00575016|O2|Outcome|Botulinum Toxin Type A (100U)|botulinum toxin Type A (100U)
1095256|NCT00575016|O1|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
1095257|NCT00575016|O4|Outcome|Placebo|Normal saline (placebo)
1095258|NCT00575016|O3|Outcome|Botulinum Toxin Type A (50U)|botulinum toxin Type A (50U)
1095259|NCT00575016|O2|Outcome|Botulinum Toxin Type A (100U)|botulinum toxin Type A (100U)
1095260|NCT00575016|O1|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
1095261|NCT00575016|O4|Outcome|Placebo|Normal saline (placebo)
1095262|NCT00575016|O3|Outcome|Botulinum Toxin Type A (50U)|botulinum toxin Type A (50U)
1095263|NCT00575016|O2|Outcome|Botulinum Toxin Type A (100U)|botulinum toxin Type A (100U)
1095264|NCT00575016|O1|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
1095265|NCT00575016|E4|Reported Event|Placebo|Normal saline (placebo)
1095266|NCT00575016|E3|Reported Event|Botulinum Toxin Type A (50U)|botulinum toxin Type A (50U)
1095267|NCT00575016|E2|Reported Event|Botulinum Toxin Type A (100U)|botulinum toxin Type A (100U)
1095268|NCT00575016|E1|Reported Event|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
1095269|NCT00574990|B4|Baseline|Total|Total of all reporting groups
1095270|NCT00574990|B3|Baseline|VA Pharmacists|VA Pharmacists who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
1095271|NCT00574990|B2|Baseline|VA Nurses|VA Nurses who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
1095272|NCT00574990|B1|Baseline|VA Physicians|VA physicians who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
1095273|NCT00574990|P3|Participant Flow|VA Pharmacists|VA Pharmacists who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
1095274|NCT00574990|P2|Participant Flow|VA Nurses|VA Nurses who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
1095275|NCT00574990|P1|Participant Flow|VA Physicians|VA Physicians who have spent at least one year in the VA and be familiar with the VA's electronic health record, CPRS.
1095276|NCT00574990|O3|Outcome|VA Pharmacists|VA pharmacists who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
1095277|NCT00574990|O2|Outcome|VA Nurses|VA nurses who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
1095278|NCT00574990|O1|Outcome|VA Physicians|VA providers who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
1095279|NCT00574990|O3|Outcome|Pharmacists|Participants were providers who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
1095280|NCT00574990|O2|Outcome|Nurses|Participants were providers who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
1095281|NCT00574990|O1|Outcome|Physicians|Participants were providers who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
1095282|NCT00574990|E3|Reported Event|VA Pharmacists|VA Pharmacists who had worked at the VA for at least one year and were familiar with the VA's electronic health record, CPRS.
1095283|NCT00574990|E2|Reported Event|VA Nurses|VA Nurses who had worked at the VA for at least one year and were familiar with the VA's electronic health record, CPRS.
1095284|NCT00574990|E1|Reported Event|VA Physicians|VA Physicians who had worked at the VA for at least one year and were familiar with the VA's electronic health record, CPRS.
1095341|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1095285|NCT00574912|B1|Baseline|1--All Interventions|"Arm: Other: 1--All interventions~All participant will be given all 5 interventions in the same order~Placebo, then 0.5 units of Glargine/kg body weight, then 1.0 units of Glargine/kg body weight, then 1.5 units of Glargine/kg body weight, then 2.0 units of Glargine/kg body weight,"
1095286|NCT00574912|P1|Participant Flow|1 All Interventions|"Other: 1--All interventions~All participant will be given all 5 interventions in the same order~Placebo, then 0.5 units of Glargine/kg body weight, then 1.0 units of Glargine/kg body weight, then 1.5 units of Glargine/kg body weight, then 2.0 units of Glargine/kg body weight,"
1095287|NCT00574912|O5|Outcome|2.0 Units of Glargine/kg|maximum glucose infusion rate
1095288|NCT00574912|O4|Outcome|1.5 Units of Glargine/kg|maximum glucose infusion rate
1095289|NCT00574912|O3|Outcome|1.0 Units of Glargine/kg|maximum glucose infusion rate
1095290|NCT00574912|O2|Outcome|0.5 Units of Glargine/kg|maximum glucose infusion rate
1095291|NCT00574912|O1|Outcome|Placebo|Maximum glucose infusion rate
1095292|NCT00574912|E5|Reported Event|2.0 Units of Glargine/kg Body Weight|"2.0 units of glargine/kg body weight~Insulin Glargine: administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five"
1095293|NCT00574912|E4|Reported Event|1.5 Units of Glargine/kg Body Weight|"1.5 units of glargine/kg body weight~Insulin Glargine: administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five"
1095294|NCT00574912|E3|Reported Event|1 Unit of Glargine/kg Body Weight|"1 unit of glargine/kg body weight~Insulin Glargine: administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five"
1095295|NCT00574912|E2|Reported Event|0.5 Units of Glargine/kg Body Weight|"0.5 units of Glargine/kg body weight~Insulin Glargine: administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five"
1095296|NCT00574912|E1|Reported Event|Placebo|"Placebo~Insulin Glargine: administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five"
1095297|NCT00574873|B3|Baseline|Total|Total of all reporting groups
1095298|NCT00574873|B2|Baseline|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
1095299|NCT00574873|B1|Baseline|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
1095300|NCT00574873|P2|Participant Flow|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
1095301|NCT00574873|P1|Participant Flow|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
1095360|NCT00574834|O1|Outcome|Ramipril|"Patients randomized to 6 months treatment of Ramipril.~Ramipril: Ramipril 20 mg once daily for 6 months"
1095302|NCT00574873|O2|Outcome|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
1095303|NCT00574873|O1|Outcome|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
1095304|NCT00574873|O2|Outcome|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
1095305|NCT00574873|O1|Outcome|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
1095306|NCT00574873|O2|Outcome|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
1095307|NCT00574873|O1|Outcome|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
1095308|NCT00574873|O2|Outcome|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
1095309|NCT00574873|O1|Outcome|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
1095310|NCT00574873|O2|Outcome|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
1095311|NCT00574873|O1|Outcome|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
1095378|NCT00574795|E3|Reported Event|13vPnC Toddler Dose|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12-15 months (toddler dose).
1095312|NCT00574873|O2|Outcome|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
1095313|NCT00574873|O1|Outcome|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
1095314|NCT00574873|E2|Reported Event|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
1095315|NCT00574873|E1|Reported Event|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
1095316|NCT00574847|B3|Baseline|Total|Total of all reporting groups
1095317|NCT00574847|B2|Baseline|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1095318|NCT00574847|B1|Baseline|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1095319|NCT00574847|P2|Participant Flow|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1095320|NCT00574847|P1|Participant Flow|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1095321|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1095322|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1095323|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1095324|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1095325|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1095433|NCT00574548|O2|Outcome|23vPS|23vPS administered as a single dose 0.5 mL IM at Year 0.
1095326|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1095327|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1095328|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1095329|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1095330|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1095331|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1095332|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1095333|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1095334|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1095335|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1095336|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1095337|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1095338|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1095339|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1095340|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1097835|NCT00567255|O2|Outcome|Placebo|Placebo
1095342|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1095343|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1095344|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1095345|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1095346|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1095347|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1095348|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1095349|NCT00574847|E2|Reported Event|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1095350|NCT00574847|E1|Reported Event|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
1095351|NCT00574834|B4|Baseline|Total|Total of all reporting groups
1095352|NCT00574834|B3|Baseline|Ramipril+HCTZ|"Patients randomized to 6 months treatment of Ramipril+HCTZ.~Ramipril+HCTZ: Ramipril 20 mg and HCTZ 25 mg, both once daily for 6 months"
1095353|NCT00574834|B2|Baseline|HCTZ|"Patients randomized to 6 months treatment of HCTZ.~HCTZ-hydrochlorothiazide: HCTZ 25 mg once daily for 6 months"
1095354|NCT00574834|B1|Baseline|Ramipril|"Patients randomized to 6 months treatment of Ramipril.~Ramipril: Ramipril 20 mg once daily for 6 months"
1095355|NCT00574834|P3|Participant Flow|Ramipril+HCTZ|"Patients randomized to 6 months treatment of Ramipril+HCTZ.~Ramipril+HCTZ: Ramipril 20 mg and HCTZ 25 mg, both once daily for 6 months"
1095356|NCT00574834|P2|Participant Flow|HCTZ|"Patients randomized to 6 months treatment of HCTZ.~HCTZ-hydrochlorothiazide: HCTZ 25 mg once daily for 6 months"
1095357|NCT00574834|P1|Participant Flow|Ramipril|"Patients randomized to 6 months treatment of Ramipril.~Ramipril: Ramipril 20 mg once daily for 6 months"
1095358|NCT00574834|O3|Outcome|Ramipril+HCTZ|"Patients randomized to 6 months treatment of Ramipril+HCTZ.~Ramipril+HCTZ: Ramipril 20 mg and HCTZ 25 mg, both once daily for 6 months"
1095359|NCT00574834|O2|Outcome|HCTZ|"Patients randomized to 6 months treatment of HCTZ.~HCTZ-hydrochlorothiazide: HCTZ 25 mg once daily for 6 months"
1095361|NCT00574834|E3|Reported Event|Ramipril+HCTZ|"Patients randomized to 6 months treatment of Ramipril+HCTZ.~Ramipril+HCTZ: Ramipril 20 mg and HCTZ 25 mg, both once daily for 6 months"
1095362|NCT00574834|E2|Reported Event|HCTZ|"Patients randomized to 6 months treatment of HCTZ.~HCTZ-hydrochlorothiazide: HCTZ 25 mg once daily for 6 months"
1095363|NCT00574834|E1|Reported Event|Ramipril|"Patients randomized to 6 months treatment of Ramipril.~Ramipril: Ramipril 20 mg once daily for 6 months"
1095364|NCT00574795|B1|Baseline|13vPnC|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series) and 12-15 months of age (toddler dose).
1095365|NCT00574795|P1|Participant Flow|13vPnC|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series) and 12-15 months of age (toddler dose).
1095366|NCT00574795|O1|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5mL dose of 13vPnC at 12-15 months of age (toddler dose)
1095367|NCT00574795|O1|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5mL dose of 13vPnC at 12-15 months of age (toddler dose)
1095368|NCT00574795|O1|Outcome|13vPnC After Infant Series|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).
1095369|NCT00574795|O4|Outcome|13vPnC Toddler Dose|Subjects received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12-15 months of age (toddler dose).
1095370|NCT00574795|O3|Outcome|13vPnC Dose 3|Subjects received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 6 months of age (infant series Dose 3).
1095371|NCT00574795|O2|Outcome|13vPnC Dose 2|Subjects received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 4 months of age (infant series Dose 2).
1095372|NCT00574795|O1|Outcome|13vPnC Dose 1|Subjects received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2 months of age (infant series Dose 1).
1095373|NCT00574795|O4|Outcome|13vPnC Toddler Dose|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12-15 months of age (toddler dose).
1095374|NCT00574795|O3|Outcome|13vPnC Dose 3|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 6 months of age (infant series Dose 3).
1095375|NCT00574795|O2|Outcome|13vPnC Dose 2|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 4 months of age (infant series Dose 2).
1095376|NCT00574795|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2 months of age (infant series Dose 1).
1095377|NCT00574795|O1|Outcome|13vPnC After Infant Series|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).
1095748|NCT00573469|E2|Reported Event|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
1095379|NCT00574795|E2|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).
1095380|NCT00574795|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).
1095381|NCT00574704|B5|Baseline|Total|Total of all reporting groups
1095382|NCT00574704|B4|Baseline|Placebo|CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
1095383|NCT00574704|B3|Baseline|QbG10|CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
1095384|NCT00574704|B2|Baseline|Allergen|House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits
1095385|NCT00574704|B1|Baseline|AllQbG10|CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits
1095386|NCT00574704|P4|Participant Flow|Placebo|CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
1095387|NCT00574704|P3|Participant Flow|QbG10|CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
1095388|NCT00574704|P2|Participant Flow|Allergen|House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits
1095389|NCT00574704|P1|Participant Flow|AllQbG10|CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits
1095390|NCT00574704|O4|Outcome|Placebo|CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
1095391|NCT00574704|O3|Outcome|QbG10|CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
1095392|NCT00574704|O2|Outcome|Allergen|House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits
1095393|NCT00574704|O1|Outcome|AllQbG10|CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits
1095394|NCT00574704|E4|Reported Event|Placebo|CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
1095395|NCT00574704|E3|Reported Event|QbG10|CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
1095396|NCT00574704|E2|Reported Event|Allergen|House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits
1095397|NCT00574704|E1|Reported Event|AllQbG10|CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits
1095398|NCT00574548|B3|Baseline|Total|Total of all reporting groups
1095399|NCT00574548|B2|Baseline|23vPS - Group 2|Group 2: 23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
1095434|NCT00574548|O1|Outcome|13vPnC / 23vPS|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
1097994|NCT00567008|O2|Outcome|Placebo|Placebo
1095400|NCT00574548|B1|Baseline|13vPnC - Group 1.1 or 1.2|Group 1.1: 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1; or Group 1.2: 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
1095401|NCT00574548|P2|Participant Flow|23vPS - Group 2|Group 2: 23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
1095402|NCT00574548|P1|Participant Flow|13vPnC - Group 1.1 or 1.2|Group 1.1: 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1; or Group 1.2: 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
1095403|NCT00574548|O3|Outcome|23vPS / 13vPnC|23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
1095404|NCT00574548|O2|Outcome|13vPnC / 23vPS|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
1095405|NCT00574548|O1|Outcome|13vPnC / 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
1095406|NCT00574548|O2|Outcome|13vPnC / 23vPS|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
1095407|NCT00574548|O1|Outcome|23vPS|23vPS administered as a single dose 0.5 mL IM at Year 0.
1095408|NCT00574548|O2|Outcome|23vPS / 13vPnC|23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
1095409|NCT00574548|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
1095410|NCT00574548|O2|Outcome|13vPnC / 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
1095411|NCT00574548|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
1095412|NCT00574548|O2|Outcome|23vPS|23vPS administered as a single dose 0.5 mL IM at Year 0.
1095413|NCT00574548|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
1095414|NCT00574548|O3|Outcome|23vPS / 13vPnC|23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
1095415|NCT00574548|O2|Outcome|13vPnC / 23vPS|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
1095749|NCT00573469|E1|Reported Event|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
1095416|NCT00574548|O1|Outcome|13vPnC / 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
1095417|NCT00574548|O2|Outcome|13vPnC / 23vPS|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
1095418|NCT00574548|O1|Outcome|23vPS|23vPS administered as a single dose 0.5 mL IM at Year 0.
1095419|NCT00574548|O2|Outcome|23vPS / 13vPnC|23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
1095420|NCT00574548|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
1095421|NCT00574548|O2|Outcome|13vPnC / 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
1095422|NCT00574548|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
1095423|NCT00574548|O2|Outcome|23vPS|23vPS administered as a single dose 0.5 mL IM at Year 0.
1095424|NCT00574548|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
1095425|NCT00574548|O2|Outcome|23vPS / 13vPnC|23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
1095426|NCT00574548|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
1095427|NCT00574548|O2|Outcome|13vPnC / 23vPS Vaccination 2 (Year 1)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
1095428|NCT00574548|O1|Outcome|13vPnC Vaccination 1 (Year 0)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
1095429|NCT00574548|O2|Outcome|13vPnC / 13vPnC Vaccination 2 (Year 1)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
1095430|NCT00574548|O1|Outcome|13vPnC Vaccination 1 (Year 0)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
1095431|NCT00574548|O2|Outcome|23vPS / 13vPnC|23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
1095432|NCT00574548|O1|Outcome|13vPnC / 23vPS|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
1095435|NCT00574548|E10|Reported Event|23vPS / 13vPnC: 6 Month Follow-up After Vax 2 (Year 1)|23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
1095436|NCT00574548|E9|Reported Event|13vPnC / 23vPS: 6 Month Follow-up After Vax 2 (Year 1)|13vPnC administered as a single dose 0.5 mL IM at Year 0. 23vPS administered as a single dose 0.5 mL IM at Year 1.
1095437|NCT00574548|E8|Reported Event|13vPnC / 13vPnC: 6 Month Follow-up After Vax 2 (Year 1)|13vPnC administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
1095438|NCT00574548|E7|Reported Event|23vPS / 13vPnC (Year 1)|"23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=32; systematic (solicited) Local Reactions N=118; systematic (solicited) Systemic Events N=68."
1095439|NCT00574548|E6|Reported Event|13vPnC / 23vPS (Year 1)|"13vPnC administered as a single dose 0.5 mL IM at Year 0. 23vPS administered as a single dose 0.5 mL IM at Year 1.~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=50; systematic (solicited) Local Reactions N=198; systematic (solicited) Systemic Events N=120."
1095440|NCT00574548|E5|Reported Event|13vPnC / 13vPnC (Year 1)|"13vPnC administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=22; systematic (solicited) Local Reactions N=97; systematic (solicited) Systemic Events N=54."
1095441|NCT00574548|E4|Reported Event|23vPS: 6 Month Follow-up After Vax 1 (Year 0)|Group 2: 23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
1095442|NCT00574548|E3|Reported Event|13vPnC: 6 Month Follow-up After Vax 1 (Year 0)|Group 1.1: 13vPnC administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1; or Group 1.2: 13vPnC administered as a single dose 0.5 mL IM at Year 0. 23vPS administered as a single dose 0.5 mL IM at Year 1.
1095443|NCT00574548|E2|Reported Event|23vPS (Year 0)|"Group 2: 23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=49; systematic (solicited) Local Reactions N=102; systematic (solicited) Systemic Events N=86."
1095444|NCT00574548|E1|Reported Event|13vPnC (Year 0)|"Group 1.1: 13vPnC administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1; or Group 1.2: 13vPnC administered as a single dose 0.5 mL IM at Year 0. 23vPS administered as a single dose 0.5 mL IM at Year 1.~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=90; systematic (solicited) Local Reactions N=256; systematic (solicited) Systemic Events N=163."
1095445|NCT00574405|B3|Baseline|Total|Total of all reporting groups
1095750|NCT00573443|B4|Baseline|Total|Total of all reporting groups
1097097|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
1095446|NCT00574405|B2|Baseline|Insulin Pump Therapy, Started at Diagnosis.|Continuous subcutaneous infusion therapy (insulin pump therapy), using Animas Corporation insulin pump, model IR 1200, started within 1 month of diagnosis with Type 1 diabetes, in patients 8-18 years of age, and monitored for 12 months after diagnosis.
1095447|NCT00574405|B1|Baseline|Multiple Daily Injection Therapy|Multiple daily injection therapy, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®) started at the time of diagnosis of Type 1 diabetes in patient 8-18 years of age and monitored for 12 months after diagnosis.
1095448|NCT00574405|P2|Participant Flow|Insulin Pump Therapy, Started at Diagnosis.|Continuous subcutaneous infusion therapy (insulin pump therapy), using Animas Corporation insulin pump, model IR 1200, started within 1 month of diagnosis with Type 1 diabetes, in patients 8-18 years of age, and monitored for 12 months after diagnosis.
1095449|NCT00574405|P1|Participant Flow|Multiple Daily Injection Therapy|Multiple daily injection therapy, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®) started at the time of diagnosis of Type 1 diabetes in patient 8-18 years of age and monitored for 12 months after diagnosis.
1095450|NCT00574405|O2|Outcome|Insulin Pump Therapy, Started at Diagnosis.|Continuous subcutaneous infusion therapy (insulin pump therapy), using Animas Corporation insulin pump, model IR 1200, started within 1 month of diagnosis with Type 1 diabetes, in patients 8-18 years of age, and monitored for 12 months after diagnosis.
1095451|NCT00574405|O1|Outcome|Multiple Daily Injection Therapy|Multiple daily injection therapy, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®) started at the time of diagnosis of Type 1 diabetes in patient 8-18 years of age and monitored for 12 months after diagnosis.
1095452|NCT00574405|E2|Reported Event|Insulin Pump Therapy, Started at Diagnosis.|Continuous subcutaneous infusion therapy (insulin pump therapy), using Animas Corporation insulin pump, model IR 1200, started within 1 month of diagnosis with Type 1 diabetes, in patients 8-18 years of age, and monitored for 12 months after diagnosis.
1095453|NCT00574405|E1|Reported Event|Multiple Daily Injection Therapy|Multiple daily injection therapy, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®) started at the time of diagnosis of Type 1 diabetes in patient 8-18 years of age and monitored for 12 months after diagnosis.
1095454|NCT00574340|B1|Baseline|All Study Participants|
1095455|NCT00574340|P2|Participant Flow|Antecedent Hypoglycemia Group Then Control Study|Day 1 hypoglycemia, Day 2 hypoglycemia Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks then participants proceeded to control study Day 1 euglycemia, day 2 hypoglycemia
1095456|NCT00574340|P1|Participant Flow|Control Study Then Antecedent Hypoglycemia Study Group|Day 1 euglycemia, day 2 hypoglycemia Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks then participants proceeded to antecedent hypoglycemia study Day 1 hypoglycemia, Day 2 hypoglycemia
1095457|NCT00574340|O2|Outcome|Antecedent Hypoglycemia Group|"Day 1 hypoglycemia, day 2 hypoglycemia~Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks"
1095458|NCT00574340|O1|Outcome|Control Group|"Day 1 euglycemia, day 2 hypoglycemia~Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks"
1095459|NCT00574340|E2|Reported Event|Antecedent Hypoglycemia Group-all Participants|"Day 1 hypoglycemia, day 2 hypoglycemia= one study~Hyperinsulinemic Hypoglycemic Clamp study: each two day study (arm) separated by 8 weeks"
1095460|NCT00574340|E1|Reported Event|Control Group- All Participants|"Day 1 euglycemia, day 2 hypoglycemia= one study~Hyperinsulinemic Euglycemic Clamp study: each two day study (arm) separated by 8 weeks"
1095461|NCT00574288|B8|Baseline|Total|Total of all reporting groups
1095462|NCT00574288|B7|Baseline|Part 2: Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the participant experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with participants received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095463|NCT00574288|B6|Baseline|Part 2: Daratumumab 8 mg/kg|Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the participant experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with participants received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions.
1095464|NCT00574288|B5|Baseline|Part 1:Daratumumab 24 mg/kg|Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095465|NCT00574288|B4|Baseline|Part 1:Daratumumab 16 mg/kg|Participants were administered with 7 full IV infusion of 16 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095466|NCT00574288|B3|Baseline|Part 1:Daratumumab 8 mg/kg|Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095467|NCT00574288|B2|Baseline|Part 1:Daratumumab 4 mg/kg|Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095468|NCT00574288|B1|Baseline|Part 1: Daratumumab Less Than (<) 4 mg/kg|Participants were administered with 7 full intravenous (IV) infusion of 0.005, 0.05, 0.1, 0.5, 1 and 2 milligram per kilogram body weight (mg/kg) daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1096034|NCT00572910|O8|Outcome|V710 (60 mcg / PBO / PBO) + MAA|Participants in Group 4B who were vaccinated with V710 (60 mcg / PBO / PBO) with MAA.
1095469|NCT00574288|P7|Participant Flow|Part 2: Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the participant experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with participants received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095470|NCT00574288|P6|Participant Flow|Part 2: Daratumumab 8 mg/kg|Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the participant experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with participants received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions.
1095471|NCT00574288|P5|Participant Flow|Part 1:Daratumumab 24 mg/kg|Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095472|NCT00574288|P4|Participant Flow|Part 1:Daratumumab 16 mg/kg|Participants were administered with 7 full IV infusion of 16 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095473|NCT00574288|P3|Participant Flow|Part 1:Daratumumab 8 mg/kg|Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095474|NCT00574288|P2|Participant Flow|Part 1:Daratumumab 4 mg/kg|Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095475|NCT00574288|P1|Participant Flow|Part 1: Daratumumab Less Than (<) 4 mg/kg|Participants were administered with 7 full intravenous (IV) infusion of 0.005, 0.05, 0.1, 0.5, 1 and 2 milligram per kilogram body weight (mg/kg) daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095476|NCT00574288|O2|Outcome|Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095638|NCT00573937|B3|Baseline|Total|Total of all reporting groups
1095640|NCT00573937|B1|Baseline|Methadone|Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.
1095477|NCT00574288|O1|Outcome|Daratumumab 8 mg/kg|Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions.
1095478|NCT00574288|O2|Outcome|Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095479|NCT00574288|O1|Outcome|Daratumumab 8 mg/kg|Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions.
1095480|NCT00574288|O2|Outcome|Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095481|NCT00574288|O1|Outcome|Daratumumab 8 mg/kg|Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions.
1095482|NCT00574288|O2|Outcome|Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095483|NCT00574288|O1|Outcome|Daratumumab 8 mg/kg|Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions.
1095935|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
1095484|NCT00574288|O2|Outcome|Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095485|NCT00574288|O1|Outcome|Daratumumab 8 mg/kg|Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions.
1095486|NCT00574288|O4|Outcome|Part 1:Daratumumab 24 mg/kg|Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095487|NCT00574288|O3|Outcome|Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095488|NCT00574288|O2|Outcome|Daratumumab 8 mg/kg|Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the subject experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions.
1095489|NCT00574288|O1|Outcome|Daratumumab 4 mg/kg|Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095490|NCT00574288|O6|Outcome|Part 2: Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the participant experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with participants received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095639|NCT00573937|B2|Baseline|Morphine|Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
1095491|NCT00574288|O5|Outcome|Part 2: Daratumumab 8 mg/kg|Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the participant experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with participants received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions.
1095492|NCT00574288|O4|Outcome|Part 1:Daratumumab 24 mg/kg|Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095493|NCT00574288|O3|Outcome|Part 1: Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w). Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095494|NCT00574288|O2|Outcome|Part 1:Daratumumab 8 mg/kg|Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095495|NCT00574288|O1|Outcome|Part 1: Daratumumab 4 mg/kg|Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095496|NCT00574288|O7|Outcome|Part 2: Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the participant experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with participants received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095497|NCT00574288|O6|Outcome|Part 2: Daratumumab 8 mg/kg|Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the participant experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with participants received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions.
1095498|NCT00574288|O5|Outcome|Part 1:Daratumumab 24 mg/kg|Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095499|NCT00574288|O4|Outcome|Part 1: Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w). Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095500|NCT00574288|O3|Outcome|Part 1:Daratumumab 8 mg/kg|Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095501|NCT00574288|O2|Outcome|Part 1: Daratumumab 4 mg/kg|Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095502|NCT00574288|O1|Outcome|Part 1: Daratumumab Less Than (<) 4 mg/kg|Participants were administered with 7 full intravenous (IV) infusion of 0.005, 0.05, 0.1, 0.5, 1 and 2 milligram per kilogram body weight (mg/kg) daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095503|NCT00574288|E7|Reported Event|Part 2: Daratumumab 16 mg/kg|Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the participant experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with participants received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095504|NCT00574288|E6|Reported Event|Part 2: Daratumumab 8 mg/kg|Participants were administered with 8 mg/kg daratumumab weekly once for 8 weeks, then every 2 week (q2w) for 16 weeks, then every 4 weeks (q4w) for up to 72 weeks or until the participant experienced disease progression or unmanageable toxicity, whichever came first (possible duration of treatment: 96 weeks). Along with participants received methylprednisolone 100 mg IV before treatment and 20–25 mg methylprednisolone orally for 2 days after all full infusions.
1095505|NCT00574288|E5|Reported Event|Part 1:Daratumumab 24 mg/kg|Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095506|NCT00574288|E4|Reported Event|Part 1:Daratumumab 16 mg/kg|Participants were administered with 7 full IV infusion of 16 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095507|NCT00574288|E3|Reported Event|Part 1:Daratumumab 8 mg/kg|Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095508|NCT00574288|E2|Reported Event|Part 1:Daratumumab 4 mg/kg|Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095509|NCT00574288|E1|Reported Event|Part 1: Daratumumab Less Than (<) 4 mg/kg|Participants were administered with 7 full intravenous (IV) infusion of 0.005, 0.05, 0.1, 0.5, 1 and 2 milligram per kilogram body weight (mg/kg) daratumumab once weekly. Along with participants received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.
1095510|NCT00574275|B3|Baseline|Total|Total of all reporting groups
1095511|NCT00574275|B2|Baseline|Aflibercept/Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
1095512|NCT00574275|B1|Baseline|Placebo/Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
1095513|NCT00574275|P2|Participant Flow|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
1095514|NCT00574275|P1|Participant Flow|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
1095515|NCT00574275|O2|Outcome|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
1095516|NCT00574275|O1|Outcome|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
1095517|NCT00574275|O2|Outcome|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
1095518|NCT00574275|O1|Outcome|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
1095519|NCT00574275|O2|Outcome|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
1095520|NCT00574275|O1|Outcome|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
1095521|NCT00574275|O2|Outcome|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
1095522|NCT00574275|O1|Outcome|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
1095523|NCT00574275|O2|Outcome|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
1095524|NCT00574275|O1|Outcome|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
1095525|NCT00574275|O2|Outcome|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
1095526|NCT00574275|O1|Outcome|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
1095527|NCT00574275|E2|Reported Event|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
1095528|NCT00574275|E1|Reported Event|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
1095529|NCT00574249|B3|Baseline|Total|Total of all reporting groups
1095530|NCT00574249|B2|Baseline|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
1095531|NCT00574249|B1|Baseline|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
1095532|NCT00574249|P2|Participant Flow|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment: subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 though Week 15 - topical ointment (calcipotriol 50 mcg/g and betamethasone 500 mg/g) to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 through Week 16 (maximum 100 g per week)
1095533|NCT00574249|P1|Participant Flow|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15 - placebo vehicle ointment to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 though Week 16 (maximum dose of 100 g per week)
1095534|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
1095535|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
1095536|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
1095537|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
1095538|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
1095539|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
1095540|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
1095541|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
1095542|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
1095543|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
1095544|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
1095545|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
1095546|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
1095936|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
1095547|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
1095548|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
1095549|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
1095550|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
1095551|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
1095552|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
1095553|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
1095554|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
1095555|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
1095556|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
1095557|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
1095558|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
1095559|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
1095560|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
1095561|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
1095562|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
1095563|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
1095564|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
1095565|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
1095566|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
1095567|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
1095568|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
1095569|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
1095570|NCT00574249|E2|Reported Event|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
1095571|NCT00574249|E1|Reported Event|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
1095572|NCT00574171|B1|Baseline|Arm 1|"Capecitabine : 2000mg/m2 of body surface area (BSA), by mouth, divided into twice daily dosing. Capecitabine will be given for days 1 through 14 of a 21 day cycle.~lapatinib : 1250mg by mouth daily one hour before or after breakfast on a continuous basis."
1095573|NCT00574171|P1|Participant Flow|Lapatinib and Capecitabine|"Capecitabine : 2000mg/m2 of body surface area (BSA), by mouth, divided into twice daily dosing. Capecitabine will be given for days 1 through 14 of a 21 day cycle.~lapatinib : 1250mg by mouth daily one hour before or after breakfast on a continuous basis."
1095574|NCT00574171|O1|Outcome|Lapatinib/Capecitabine|lapatinib: 1250mg by mouth daily one hour before or after breakfast on a continuous basis. Capecitabine: 2000mg/m2 of body surface area (BSA), by mouth, divided into twice daily dosing. Capecitabine will be given for days 1 through 14 of a 21 day cycle.
1095575|NCT00574171|E1|Reported Event|Arm 1|"Capecitabine : 2000mg/m2 of body surface area (BSA), by mouth, divided into twice daily dosing. Capecitabine will be given for days 1 through 14 of a 21 day cycle.~lapatinib : 1250mg by mouth daily one hour before or after breakfast on a continuous basis."
1095576|NCT00574145|B3|Baseline|Total|Total of all reporting groups
1095577|NCT00574145|B2|Baseline|Control ARM (B)|Patients receive radiotherapy and sham healing touch therapy from a sham healing touch therapist once a week for the duration of their radiotherapy
1095578|NCT00574145|B1|Baseline|Radiotherapy/Supportive Care (A)|Patients receive radiotherapy and healing touch therapy from a healing touch therapist once a week for the duration of their radiotherapy
1095937|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
1095579|NCT00574145|P2|Participant Flow|Control ARM (B)|Patients receive radiotherapy and sham healing touch therapy from a sham healing touch therapist once a week for the duration of their radiotherapy
1095580|NCT00574145|P1|Participant Flow|Radiotherapy/Supportive Care (A)|Patients receive radiotherapy and healing touch therapy from a healing touch therapist once a week for the duration of their radiotherapy
1095581|NCT00574145|O2|Outcome|Control ARM (B)|Patients receive radiotherapy and sham healing touch therapy from a sham healing-touch therapist once a week for the duration of their radiotherapy
1095582|NCT00574145|O1|Outcome|Radiotherapy/Supportive Care (A)|Patients receive radiotherapy and healing touch therapy from a healing-touch therapist once a week for the duration of their radiotherapy
1095583|NCT00574145|O2|Outcome|Control ARM (B)|Patients receive radiotherapy and sham healing touch therapy from a sham healing-touch therapist once a week for the duration of their radiotherapy
1095584|NCT00574145|O1|Outcome|Radiotherapy/Supportive Care (A)|Patients receive radiotherapy and healing touch therapy from a healing-touch therapist once a week for the duration of their radiotherapy
1095585|NCT00574145|O2|Outcome|Control ARM (B)|Patients receive radiotherapy and sham healing touch therapy from a sham healing-touch therapist once a week for the duration of their radiotherapy
1095586|NCT00574145|O1|Outcome|Radiotherapy/Supportive Care (A)|Patients receive radiotherapy and healing touch therapy from a healing-touch therapist once a week for the duration of their radiotherapy
1095587|NCT00574145|E2|Reported Event|Control ARM (B)|Patients receive radiotherapy and sham healing touch therapy from a sham healing touch therapist once a week for the duration of their radiotherapy
1095588|NCT00574145|E1|Reported Event|Radiotherapy/Supportive Care (A)|Patients receive radiotherapy and healing touch therapy from a healing touch therapist once a week for the duration of their radiotherapy
1095589|NCT00574080|B3|Baseline|Total|Total of all reporting groups
1095590|NCT00574080|B2|Baseline|DPACE/Melphalan|Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
1095591|NCT00574080|B1|Baseline|VTD + DPACE/Melphalan|Velcade, thalidomide, and dexamethasone + Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
1095592|NCT00574080|P2|Participant Flow|DPACE/Melphalan|Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
1095593|NCT00574080|P1|Participant Flow|VTD + DPACE/Melphalan|Velcade, thalidomide, and dexamethasone + Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
1095594|NCT00574080|O1|Outcome|Velcade, Thalidomide, and Dexamethasone|
1095595|NCT00574080|E2|Reported Event|DPACE/Melphalan|Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
1095596|NCT00574080|E1|Reported Event|VTD + DPACE/Melphalan|Velcade, thalidomide, and dexamethasone + Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
1095597|NCT00574067|B5|Baseline|Total|Total of all reporting groups
1097995|NCT00567008|O1|Outcome|Varenicline|Varenicline (Chantix)
1095598|NCT00574067|B4|Baseline|C+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
1095599|NCT00574067|B3|Baseline|C+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
1095600|NCT00574067|B2|Baseline|B+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
1095601|NCT00574067|B1|Baseline|B+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
1095602|NCT00574067|P4|Participant Flow|Counseling+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
1095603|NCT00574067|P3|Participant Flow|Counseling+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
1095604|NCT00574067|P2|Participant Flow|Bup+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
1095605|NCT00574067|P1|Participant Flow|Bup+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
1095606|NCT00574067|O4|Outcome|C+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
1095607|NCT00574067|O3|Outcome|C+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
1095608|NCT00574067|O2|Outcome|B+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
1095609|NCT00574067|O1|Outcome|B+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
1095610|NCT00574067|O4|Outcome|C+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
1095611|NCT00574067|O3|Outcome|C+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
1095612|NCT00574067|O2|Outcome|B+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
1095613|NCT00574067|O1|Outcome|B+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
1095614|NCT00574067|O4|Outcome|C+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
1095615|NCT00574067|O3|Outcome|C+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
1095616|NCT00574067|O2|Outcome|B+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
1095617|NCT00574067|O1|Outcome|B+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
1095712|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
1095618|NCT00574067|O4|Outcome|Counseling+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
1095619|NCT00574067|O3|Outcome|Counseling+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
1095620|NCT00574067|O2|Outcome|Bup+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
1095621|NCT00574067|O1|Outcome|Bup+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
1095622|NCT00574067|O4|Outcome|Counseling+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
1095623|NCT00574067|O3|Outcome|Counseling+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
1095624|NCT00574067|O2|Outcome|Bup+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
1095625|NCT00574067|O1|Outcome|Bup+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
1095626|NCT00574067|O4|Outcome|C+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
1095627|NCT00574067|O3|Outcome|C+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
1095628|NCT00574067|O2|Outcome|B+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
1096080|NCT00572897|O2|Outcome|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
1095629|NCT00574067|O1|Outcome|B+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
1095630|NCT00574067|O4|Outcome|Counseling+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
1095631|NCT00574067|O3|Outcome|Counseling+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
1095632|NCT00574067|O2|Outcome|Bup+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
1095633|NCT00574067|O1|Outcome|Bup+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
1095634|NCT00574067|E4|Reported Event|C+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
1095635|NCT00574067|E3|Reported Event|C+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
1095636|NCT00574067|E2|Reported Event|B+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
1095637|NCT00574067|E1|Reported Event|B+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
1095641|NCT00573937|P2|Participant Flow|Morphine|Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
1095642|NCT00573937|P1|Participant Flow|Methadone|Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.
1095643|NCT00573937|O2|Outcome|Morphine|Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
1095644|NCT00573937|O1|Outcome|Methadone|Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.
1095645|NCT00573937|O2|Outcome|Morphine|Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
1095646|NCT00573937|O1|Outcome|Methadone|Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.
1095647|NCT00573937|E2|Reported Event|Morphine|Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
1095648|NCT00573937|E1|Reported Event|Methadone|Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.
1095649|NCT00573859|B1|Baseline|ADHD Medication Versus Placebo|Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
1095650|NCT00573859|P1|Participant Flow|ADHD Medication Versus Placebo|Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
1095651|NCT00573859|O1|Outcome|ADHD Medication Versus Placebo|Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
1095683|NCT00573755|O2|Outcome|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1096035|NCT00572910|O7|Outcome|V710 (60 mcg / PBO / 60 mcg) + MAA|Participants in Group 4A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) with MAA.
1095652|NCT00573859|O1|Outcome|ADHD Medication Versus Placebo|Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
1095653|NCT00573859|O1|Outcome|ADHD Medication Versus Placebo|Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
1095654|NCT00573859|E1|Reported Event|ADHD Medication Versus Placebo|Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
1095655|NCT00573768|B4|Baseline|Total|Total of all reporting groups
1095656|NCT00573768|B3|Baseline|Vehicle Gel|BID application
1095657|NCT00573768|B2|Baseline|DDEA 2.32% Gel OD|Once daily (OD) application of active gel and OD application of vehicle gel
1095658|NCT00573768|B1|Baseline|Diclofenac Diethylamine (DDEA) 2.32% Gel BID|Twice daily (BID) application
1095659|NCT00573768|P3|Participant Flow|Vehicle Gel|BID application
1095660|NCT00573768|P2|Participant Flow|DDEA 2.32% Gel OD|Once daily (OD) application of active gel and OD application of vehicle gel
1095661|NCT00573768|P1|Participant Flow|Diclofenac Diethylamine (DDEA) 2.32% Gel BID|Twice daily (BID) application
1095662|NCT00573768|O3|Outcome|Vehicle Gel|BID application
1095663|NCT00573768|O2|Outcome|DDEA 2.32% Gel OD|Once daily (OD) application of active gel and OD application of vehicle gel
1095664|NCT00573768|O1|Outcome|Diclofenac Diethylamine (DDEA) 2.32% Gel BID|Twice daily (BID) application
1095665|NCT00573768|E3|Reported Event|Vehicle Gel|BID application
1095666|NCT00573768|E2|Reported Event|DDEA 2.32% Gel OD|Once daily (OD) application of active gel and OD application of vehicle gel
1095667|NCT00573768|E1|Reported Event|Diclofenac Diethylamine (DDEA) 2.32% Gel BID|Twice daily (BID) application
1095668|NCT00573755|B3|Baseline|Total|Total of all reporting groups
1095669|NCT00573755|B2|Baseline|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1095713|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
1095670|NCT00573755|B1|Baseline|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1095671|NCT00573755|P2|Participant Flow|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1095672|NCT00573755|P1|Participant Flow|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1095673|NCT00573755|O2|Outcome|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1095674|NCT00573755|O1|Outcome|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1095675|NCT00573755|O2|Outcome|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1095676|NCT00573755|O1|Outcome|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1095677|NCT00573755|O2|Outcome|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1095678|NCT00573755|O1|Outcome|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1095679|NCT00573755|O2|Outcome|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1095680|NCT00573755|O1|Outcome|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1095681|NCT00573755|O2|Outcome|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1095682|NCT00573755|O1|Outcome|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1095746|NCT00573469|O1|Outcome|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
1095684|NCT00573755|O1|Outcome|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1095685|NCT00573755|E2|Reported Event|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1095686|NCT00573755|E1|Reported Event|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1095687|NCT00573534|B1|Baseline|Group 1|Adolescents with ADHD and an older sibling with substance use disorder
1095688|NCT00573534|P1|Participant Flow|Group 1|Adolescents with ADHD and an older sibling with Substance Use Disorder
1095689|NCT00573534|O1|Outcome|Lisdexamfetamine Plus Family Therapy|patients received lisdexamfetamine up to 70 mgs plus family counseling
1095690|NCT00573534|O1|Outcome|Group 1|Lisdexamfetamine and family counseling
1095691|NCT00573534|E1|Reported Event|Group 1|Intervention with Vyvanse
1095692|NCT00573508|B3|Baseline|Total|Total of all reporting groups
1095693|NCT00573508|B2|Baseline|Solifenacin Succinate|5mg or 10mg tablet taken once daily
1095694|NCT00573508|B1|Baseline|Placebo|Matching placebo tablet taken once daily
1095695|NCT00573508|P2|Participant Flow|Solifenacin Succinate|5mg or 10mg tablet taken once daily
1095696|NCT00573508|P1|Participant Flow|Placebo|Matching placebo tablet taken once daily
1095697|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
1095698|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
1095699|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
1095700|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
1095701|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
1095702|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
1095703|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
1095704|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
1095705|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
1095706|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
1095707|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
1095708|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
1095709|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
1095710|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
1095711|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
1097996|NCT00567008|E2|Reported Event|Placebo|Placebo
1095714|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
1095715|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
1095716|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
1095717|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
1095718|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
1095719|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
1095720|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
1095721|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
1095722|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
1095723|NCT00573508|E2|Reported Event|Solifenacin Succinate|5mg or 10mg tablet taken once daily
1095724|NCT00573508|E1|Reported Event|Placebo|Matching placebo tablet taken once daily
1095725|NCT00573469|B4|Baseline|Total|Total of all reporting groups
1095726|NCT00573469|B3|Baseline|Placebo|An enteric capsule without D9421-C was given once daily.
1095727|NCT00573469|B2|Baseline|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
1095728|NCT00573469|B1|Baseline|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
1095729|NCT00573469|P3|Participant Flow|Placebo|An enteric capsule without D9421-C was given once daily.
1095730|NCT00573469|P2|Participant Flow|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
1095731|NCT00573469|P1|Participant Flow|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
1095732|NCT00573469|O3|Outcome|Placebo|An enteric capsule without D9421-C was given once daily.
1095733|NCT00573469|O2|Outcome|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
1095734|NCT00573469|O1|Outcome|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
1095735|NCT00573469|O3|Outcome|Placebo|An enteric capsule without D9421-C was given once daily.
1095736|NCT00573469|O2|Outcome|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
1095737|NCT00573469|O1|Outcome|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
1095738|NCT00573469|O3|Outcome|Placebo|An enteric capsule without D9421-C was given once daily.
1095739|NCT00573469|O2|Outcome|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
1095740|NCT00573469|O1|Outcome|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
1095741|NCT00573469|O3|Outcome|Placebo|An enteric capsule without D9421-C was given once daily.
1095742|NCT00573469|O2|Outcome|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
1095743|NCT00573469|O1|Outcome|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
1095744|NCT00573469|O3|Outcome|Placebo|An enteric capsule without D9421-C was given once daily.
1095745|NCT00573469|O2|Outcome|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
1095751|NCT00573443|B3|Baseline|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
1095752|NCT00573443|B2|Baseline|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
1095753|NCT00573443|B1|Baseline|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
1095754|NCT00573443|P3|Participant Flow|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
1095755|NCT00573443|P2|Participant Flow|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
1095756|NCT00573443|P1|Participant Flow|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
1095757|NCT00573443|O3|Outcome|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
1095758|NCT00573443|O2|Outcome|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
1095759|NCT00573443|O1|Outcome|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
1095760|NCT00573443|O3|Outcome|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
1095761|NCT00573443|O2|Outcome|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
1095762|NCT00573443|O1|Outcome|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
1095763|NCT00573443|O3|Outcome|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
1095764|NCT00573443|O2|Outcome|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
1095765|NCT00573443|O1|Outcome|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
1095766|NCT00573443|O3|Outcome|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
1095767|NCT00573443|O2|Outcome|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
1095768|NCT00573443|O1|Outcome|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
1095769|NCT00573443|O3|Outcome|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
1095811|NCT00573391|P1|Participant Flow|Velcade, Thalidomide, and Dexamethasone|Velcade 1.0 mg/m^2 Velcade 1.3 mg/m^2 D1,4, 8, 11 (x 6 cycles, then 1.0 mg/m^2 (for cycles 7-12) Thalidomide 100 mg D1-28 Dexamethasone 20 mg D1-4 and 8-11
1095770|NCT00573443|O2|Outcome|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
1095771|NCT00573443|O1|Outcome|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
1095772|NCT00573443|O3|Outcome|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
1095773|NCT00573443|O2|Outcome|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
1095774|NCT00573443|O1|Outcome|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
1095775|NCT00573443|O3|Outcome|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
1095776|NCT00573443|O2|Outcome|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
1095777|NCT00573443|O1|Outcome|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
1095778|NCT00573443|E4|Reported Event|AVP-923-30 (Open Label)|Optional 12-week Open Label phase for subjects who completed 12-week DB phase.
1095779|NCT00573443|E3|Reported Event|Placebo (Double-blind)|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period.
1095780|NCT00573443|E2|Reported Event|AVP-923-20 (Double-blind)|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period.
1095836|NCT00573287|O2|Outcome|Risperidone|risperidone: risperidone--tablets, 0.5-5.0mg daily for 24 weeks
1095781|NCT00573443|E1|Reported Event|AVP-923-30 (Double-blind)|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period.
1095782|NCT00573430|B4|Baseline|Total|Total of all reporting groups
1095783|NCT00573430|B3|Baseline|Candesartan 32mg|Candesartan 32mg oral once daily dose
1095784|NCT00573430|B2|Baseline|Candesartan 16mg|Candesartan 16mg oral once daily dose
1095785|NCT00573430|B1|Baseline|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
1095786|NCT00573430|P3|Participant Flow|Candesartan 32mg|Candesartan 32mg oral once daily dose
1095787|NCT00573430|P2|Participant Flow|Candesartan 16mg|Candesartan 16mg oral once daily dose
1095788|NCT00573430|P1|Participant Flow|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
1095789|NCT00573430|O3|Outcome|Candesartan 32mg|Candesartan 32mg oral once daily dose
1095790|NCT00573430|O2|Outcome|Candesartan 16mg|Candesartan 16mg oral once daily dose
1095791|NCT00573430|O1|Outcome|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
1095792|NCT00573430|O3|Outcome|Candesartan 32mg|Candesartan 32mg oral once daily dose
1095793|NCT00573430|O2|Outcome|Candesartan 16mg|Candesartan 16mg oral once daily dose
1095794|NCT00573430|O1|Outcome|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
1095795|NCT00573430|O3|Outcome|Candesartan 32mg|Candesartan 32mg oral once daily dose
1095796|NCT00573430|O2|Outcome|Candesartan 16mg|Candesartan 16mg oral once daily dose
1095797|NCT00573430|O1|Outcome|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
1095798|NCT00573430|O3|Outcome|Candesartan 32mg|Candesartan 32mg oral once daily dose
1095799|NCT00573430|O2|Outcome|Candesartan 16mg|Candesartan 16mg oral once daily dose
1095800|NCT00573430|O1|Outcome|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
1095801|NCT00573430|O3|Outcome|Candesartan 32mg|Candesartan 32mg oral once daily dose
1095802|NCT00573430|O2|Outcome|Candesartan 16mg|Candesartan 16mg oral once daily dose
1095803|NCT00573430|O1|Outcome|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
1095804|NCT00573430|E3|Reported Event|Candesartan 32mg|Candesartan 32mg oral once daily dose
1095805|NCT00573430|E2|Reported Event|Candesartan 16mg|Candesartan 16mg oral once daily dose
1095806|NCT00573430|E1|Reported Event|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
1095807|NCT00573391|B3|Baseline|Total|Total of all reporting groups
1095808|NCT00573391|B2|Baseline|VMD With Melphalan Dose Escalation|"VMD:~Velcade 1.3 mg/m^2 D1, 4, 7, 10 (x6 mo, then 1.0 mg/m^2) Melphalan 4 (6, 8, 10) mg/m^2 D1, 4, 7, 10 dose escalation Dexamethasone 20 mg 1-4 and 7-10"
1095809|NCT00573391|B1|Baseline|Velcade, Thalidomide, and Dexamethasone|Velcade 1.0 mg/m^2 Velcade 1.3 mg/m^2 D1,4, 8, 11 (x 6 cycles, then 1.0 mg/m^2 (for cycles 7-12) Thalidomide 100 mg D1-28 Dexamethasone 20 mg D1-4 and 8-11
1095810|NCT00573391|P2|Participant Flow|VMD With Melphalan Dose Escalation|"VMD:~Velcade 1.3 mg/m^2 D1, 4, 7, 10 (x6 mo, then 1.0 mg/m^2) Melphalan 4 (6, 8, 10) mg/m^2 D1, 4, 7, 10 dose escalation Dexamethasone 20 mg 1-4 and 7-10"
1095812|NCT00573391|O2|Outcome|VMD With Melphalan Dose Escalation|"VMD:~Velcade 1.3 mg/m^2 D1, 4, 7, 10 (x6 mo, then 1.0 mg/m^2) Melphalan 4 (6, 8, 10) mg/m^2 D1, 4, 7, 10 dose escalation Dexamethasone 20 mg 1-4 and 7-10"
1095813|NCT00573391|O1|Outcome|Velcade, Thalidomide, and Dexamethasone|Velcade 1.0 mg/m^2 Velcade 1.3 mg/m^2 D1,4, 8, 11 (x 6 cycles, then 1.0 mg/m^2 (for cycles 7-12) Thalidomide 100 mg D1-28 Dexamethasone 20 mg D1-4 and 8-11
1095814|NCT00573391|E2|Reported Event|VMD With Melphalan Dose Escalation|"VMD:~Velcade 1.3 mg/m^2 D1, 4, 7, 10 (x6 mo, then 1.0 mg/m^2) Melphalan 4 (6, 8, 10) mg/m^2 D1, 4, 7, 10 dose escalation Dexamethasone 20 mg 1-4 and 7-10"
1095815|NCT00573391|E1|Reported Event|Velcade, Thalidomide, and Dexamethasone|Velcade 1.0 mg/m^2 Velcade 1.3 mg/m^2 D1,4, 8, 11 (x 6 cycles, then 1.0 mg/m^2 (for cycles 7-12) Thalidomide 100 mg D1-28 Dexamethasone 20 mg D1-4 and 8-11
1095816|NCT00573313|B5|Baseline|Total|Total of all reporting groups
1095817|NCT00573313|B4|Baseline|Sugar Pill Placebo|The placebo group received a sugar pill identical in appearance that was taken three times daily.
1095818|NCT00573313|B3|Baseline|Lifestyle Counseling|Active drinkers non liver disease subjects
1095819|NCT00573313|B2|Baseline|Healthy|Healthy subjects without alcoholism or liver disease.
1095820|NCT00573313|B1|Baseline|S-adenosylmethionine (SAMe) Treatment|The treatment group received S-adenosylmethionine (SAM) 400 mg three times daily.
1095821|NCT00573313|P4|Participant Flow|Lifestyle Counseling|Subjects were enrolled into this arm for baseline measurements only.
1095822|NCT00573313|P3|Participant Flow|Sugar Pill|ALD subjects receiving Placebo three times daily for 24 weeks.
1095823|NCT00573313|P2|Participant Flow|Healthy|Subjects were enrolled into this arm for baseline measurement only.
1095824|NCT00573313|P1|Participant Flow|S-adenosylmethionine (SAMe)|Alcoholic liver disease patients receiving S-adenosylmethionine (SAMe)at 400 mg capsule three times daily for 24 weeks.
1095825|NCT00573313|O2|Outcome|Sugar Pill|ALD subjects receiving placebo sugar pill three times daily for 24 weeks.
1095826|NCT00573313|O1|Outcome|S-adenosylmethionine (SAMe)|Alcoholic liver disease patients receiving S-adenosylmethionine (SAMe)at 400 mg capsule three times daily for 24 weeks.
1095827|NCT00573313|O2|Outcome|Sugar Pill|ALD subjects receiving Placebo three times daily for 24 weeks.
1095828|NCT00573313|O1|Outcome|S-adenosylmethionine (SAMe)|Alcoholic liver disease patients receiving S-adenosylmethionine (SAMe)at 400 mg capsule three times daily for 24 weeks.
1095829|NCT00573313|E2|Reported Event|Sugar Pill Placebo|The placebo group received a sugar pill identical in appearance that was taken three times daily.
1095830|NCT00573313|E1|Reported Event|S-adenosylmethionine (SAMe) Treatment|The treatment group received S-adenosylmethionine (SAM) 400 mg three times daily.
1095831|NCT00573287|B3|Baseline|Total|Total of all reporting groups
1095832|NCT00573287|B2|Baseline|Risperidone|risperidone: risperidone--tablets, 0.5-5.0mg daily for 24 weeks
1095833|NCT00573287|B1|Baseline|Clozapine|clozapine: clozapine--tablets, 12.5-100 mg, daily for 24 weeks
1095834|NCT00573287|P2|Participant Flow|Risperidone|risperidone: risperidone--tablets, 0.5-5.0mg daily for 24 weeks
1095835|NCT00573287|P1|Participant Flow|Clozapine|clozapine: clozapine--tablets, 12.5-100 mg, daily for 24 weeks
1095837|NCT00573287|O1|Outcome|Clozapine|clozapine: clozapine--tablets, 12.5-100 mg, daily for 24 weeks
1095838|NCT00573287|E2|Reported Event|Risperidone|risperidone: risperidone--tablets, 0.5-5.0mg daily for 24 weeks
1095839|NCT00573287|E1|Reported Event|Clozapine|clozapine: clozapine--tablets, 12.5-100 mg, daily for 24 weeks
1095840|NCT00573261|B3|Baseline|Total|Total of all reporting groups
1095841|NCT00573261|B2|Baseline|Placebo|"Placebo~Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
1095842|NCT00573261|B1|Baseline|Pregabalin|"Pregabalin medication~Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
1095843|NCT00573261|P2|Participant Flow|Pregabalin|"Pregabalin medication~Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
1095844|NCT00573261|P1|Participant Flow|Placebo|"Placebo~Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
1095845|NCT00573261|O2|Outcome|Pregabalin|Pregabalin
1095846|NCT00573261|O1|Outcome|Placebo|Placebo
1095847|NCT00573261|O2|Outcome|Pregabalin|Pregabalin
1095848|NCT00573261|O1|Outcome|Placebo|Placebo
1095849|NCT00573261|O2|Outcome|Pregabalin|"Pregabalin~Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
1095850|NCT00573261|O1|Outcome|Placebo|"Placebo~Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
1095851|NCT00573261|O2|Outcome|Pregabalin|"Pregabalin~Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
1095852|NCT00573261|O1|Outcome|Placebo|"Placebo~Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
1095853|NCT00573261|O2|Outcome|Pregabalin|"Pregabalin~Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
1095854|NCT00573261|O1|Outcome|Placebo|"Placebo~Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
1095855|NCT00573261|O2|Outcome|Pregabalin|Pregabalin
1095856|NCT00573261|O1|Outcome|Placebo|Placebo
1095857|NCT00573261|O2|Outcome|Pregabalin|"Pregabalin~Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
1095858|NCT00573261|O1|Outcome|Placebo|"Placebo~Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
1095859|NCT00573261|O2|Outcome|Pregabalin|Pregabalin
1095860|NCT00573261|O1|Outcome|Placebo|Placebo
1095861|NCT00573261|O2|Outcome|Pregabalin|Pregabalin
1095867|NCT00573261|E2|Reported Event|Pregabalin|"Pregabalin medication~Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
1095868|NCT00573261|E1|Reported Event|Placebo|"Placebo~Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
1095869|NCT00573248|B3|Baseline|Total|Total of all reporting groups
1095870|NCT00573248|B2|Baseline|Nonsmokers|In a modified within-group cross-over, nonsmokers received 7 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.
1095871|NCT00573248|B1|Baseline|Smokers|In a modified within-group cross-over, smokers received 21 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.
1095872|NCT00573248|P2|Participant Flow|Nonsmokers|In a modified within-group cross-over, nonsmokers received 7 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.
1095873|NCT00573248|P1|Participant Flow|Smokers|In a modified within-group cross-over, smokers received 21 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.
1095874|NCT00573248|O2|Outcome|Placebo Patches|Smokers and nonsmokers received placebo patches for two consecutive days.
1095875|NCT00573248|O1|Outcome|Nicotine Patches|Smokers received 21 mg/day patches for two consecutive days and nonsmokers received 7 mg/day nicotine patches for two consecutive days.
1095876|NCT00573248|O2|Outcome|Placebo Patches|Smokers and nonsmokers received placebo patches for two consecutive days.
1095877|NCT00573248|O1|Outcome|Nicotine Patches|Smokers received 21 mg/day patches for two consecutive days and nonsmokers received 7 mg/day nicotine patches for two consecutive days.
1095878|NCT00573248|O2|Outcome|Placebo Patches|Smokers and nonsmokers received placebo patches for two consecutive days.
1095879|NCT00573248|O1|Outcome|Nicotine Patches|Smokers received 21 mg/day patches for two consecutive days and nonsmokers received 7 mg/day nicotine patches for two consecutive days.
1095880|NCT00573248|O2|Outcome|Placebo Patches|Smokers and nonsmokers received placebo patches for two consecutive days.
1095881|NCT00573248|O1|Outcome|Nicotine Patches|Smokers received 21 mg/day patches for two consecutive days and nonsmokers received 7 mg/day nicotine patches for two consecutive days.
1095882|NCT00573248|E2|Reported Event|Nonsmokers|In a modified within-group cross-over, nonsmokers received 7 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.
1095883|NCT00573248|E1|Reported Event|Smokers|In a modified within-group cross-over, smokers received 21 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.
1095884|NCT00573183|B3|Baseline|Total|Total of all reporting groups
1095885|NCT00573183|B2|Baseline|Treatment as Usual|Received standard care provided in intensive outpatient drug treatment program
1095906|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
1095907|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
1095886|NCT00573183|B1|Baseline|STAGE-12|Received 3 individual and 5 group sessions focusing on 12-step principles plus an intensive referral in which counselors linked participants to community-based 12-step volunteers. These sessions took the place of 3 individual and 5 group sessions in the standard intensive outpatient drug treatment program.
1095887|NCT00573183|P2|Participant Flow|Treatment as Usual|Received standard care provided in intensive outpatient drug treatment program
1095888|NCT00573183|P1|Participant Flow|STAGE-12|Received 3 individual and 5 group sessions focusing on 12-step principles plus an intensive referral in which counselors linked participants to community-based 12-step volunteers. These sessions took the place of 3 individual and 5 group sessions in the standard intensive outpatient drug treatment program.
1095889|NCT00573183|O2|Outcome|Treatment as Usual|Standard treatment as usual in intensive outpatient substance abuse treatment program
1095890|NCT00573183|O1|Outcome|STAGE-12|Received 3 individual and 5 group sessions focusing on 12-step principles plus an intensive referral in which counselors linked participants to community-based 12-step volunteers. These sessions took the place of 3 individual and 5 group sessions.
1095891|NCT00573183|O2|Outcome|STAGE-12|Received 3 individual and 5 group sessions focusing on 12-step principles plus an intensive referral in which counselors linked participants to community-based 12-step volunteers. These sessions took the place of 3 individual and 5 group sessions.
1095892|NCT00573183|O1|Outcome|Treatment as Usual|Standard treatment as usual in intensive outpatient substance abuse treatment program
1095893|NCT00573183|E2|Reported Event|Treatment as Usual|Standard treatment as usual in intensive outpatient substance abuse treatment program
1095894|NCT00573183|E1|Reported Event|STAGE-12|Received 3 individual and 5 group sessions focusing on 12-step principles plus an intensive referral in which counselors linked participants to community-based 12-step volunteers. These sessions took the place of 3 individual and 5 group sessions.
1095895|NCT00573170|B1|Baseline|All Study Participants Treated at Least Once|All study participants who were treated at least once with study medication
1095896|NCT00573170|P6|Participant Flow|Placebo, Butalbital-containing Combo. Medication, Treximet|Matching placebo for treatment of first migraine attack, followed by a 7-day washout period; comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of second migraine attack, followed by a 7-day washout period; fixed dose combination tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of third migraine attack. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated.
1095897|NCT00573170|P5|Participant Flow|Placebo, Treximet, Butalbital-containing Combo. Medication|Matching placebo for treatment of first migraine attack, followed by a 7-day washout period; fixed dose combination tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of second migraine attack, followed by a 7-day washout period; comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of third migraine attack. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated.
1095898|NCT00573170|P4|Participant Flow|Butalbital-containing Combo. Medication, Placebo, Treximet|Comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of first migraine attack, followed by a 7-day washout period; matching placebo for treatment of second migraine attack, followed by a 7-day washout period; fixed dose combination tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of third migraine attack. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated.
1095899|NCT00573170|P3|Participant Flow|Butalbital-containing Combo. Medication, Treximet, Placebo|Comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of first migraine attack, followed by a 7-day washout period; fixed dose combination tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of second migraine attack, followed by a 7-day washout period; matching placebo for treatment of third migraine attack, followed by a 7-day washout period. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated.
1095900|NCT00573170|P2|Participant Flow|Treximet, Butalbital-containing Combo. Medication, Placebo|Fixed dose combination tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of first migraine attack, followed by a 7-day washout period; comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of second migraine attack, followed by a 7-day washout period; matching placebo for treatment of third migraine attack, followed by a 7-day washout period. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated.
1095901|NCT00573170|P1|Participant Flow|Treximet, Placebo, Butalbital-containing Combo. Medication|Fixed dose combination (combo.) tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of first migraine attack, followed by a 7-day washout period; matching placebo for treatment of second migraine attack, followed by a 7-day washout period; comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of third migraine attack. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated.
1095902|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
1095903|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
1095904|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
1095905|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
1097997|NCT00567008|E1|Reported Event|Varenicline|Varenicline (Chantix)
1095908|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
1095909|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
1095910|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
1095911|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
1095912|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
1095913|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
1095914|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
1095915|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
1095916|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
1095917|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
1095918|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
1095919|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
1095920|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
1095921|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
1095922|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
1095923|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
1095924|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
1095925|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
1095926|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
1095927|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
1095928|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
1095929|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
1095930|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
1095931|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
1095932|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
1095938|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
1095939|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
1095940|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
1095941|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
1095942|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
1095943|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
1095944|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
1095945|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
1095946|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
1095947|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
1095948|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
1095949|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
1095950|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
1095951|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
1095952|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
1095953|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Participants taking any rescue medication within 48 hours of treating Migraine Attack 3 with Butalbital-containing combination medication
1095954|NCT00573170|O2|Outcome|Treximet|Participants taking any rescue medication within 48 hours of treating Migraine Attack 3 with Treximet
1095955|NCT00573170|O1|Outcome|Placebo|Participants taking any rescue medication within 48 hours of treating Migraine Attack 3 with placebo
1095956|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Participants taking any rescue medication within 48 hours of treating Migraine Attack 2 with Butalbital-containing combination medication
1095957|NCT00573170|O2|Outcome|Treximet|Participants taking any rescue medication within 48 hours of treating Migraine Attack 2 with Treximet
1095958|NCT00573170|O1|Outcome|Placebo|Participants taking any rescue medication within 48 hours of treating Migraine Attack 2 with placebo
1095959|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Participants taking any rescue medication within 48 hours of treating Migraine Attack 1 with Butalbital-containing combination medication
1095960|NCT00573170|O2|Outcome|Treximet|Participants taking any rescue medication within 48 hours of treating Migraine Attack 1 with Treximet
1095961|NCT00573170|O1|Outcome|Placebo|Participants taking any rescue medication within 48 hours of treating Migraine Attack 1 with placebo
1096164|NCT00572533|B2|Baseline|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
1095962|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
1095963|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
1095964|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
1095965|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
1095966|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
1095967|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
1095968|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
1095969|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
1095970|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
1095971|NCT00573170|E3|Reported Event|Butalbital-containing Combination Medication|Participants who reported an SAE anytime after initial treatment with blinded Butalbital-containing combination medication, but before another initial treatment with any other investigational product
1095972|NCT00573170|E2|Reported Event|Treximet|Participants who reported an SAE anytime after initial treatment with blinded Treximet, but before another initial treatment with any other investigational product
1095973|NCT00573170|E1|Reported Event|Placebo|Participants who reported an SAE anytime after initial treatment with blinded placebo, but before another initial treatment with any other investigational product
1095974|NCT00573157|B3|Baseline|Total|Total of all reporting groups
1095975|NCT00573157|B2|Baseline|Placebo Plus Mycophenolate Mofetil Plus Corticosteroids|Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
1095976|NCT00573157|B1|Baseline|Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids|Atacicept was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
1095994|NCT00573144|O2|Outcome|Nesiritide|"Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.~Nesiritide: Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min."
1096036|NCT00572910|O6|Outcome|V710 (60 mcg / 60 mcg / PBO) + MAA|Participants in Group 3B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) with MAA.
1095977|NCT00573157|P2|Participant Flow|Placebo Plus Mycophenolate Mofetil Plus Corticosteroids|Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
1095978|NCT00573157|P1|Participant Flow|Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids|Atacicept was administered subcutaneously (SC) at a loading dose of 150 milligram (mg) twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose corticosteroids (CS) of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
1095979|NCT00573157|O2|Outcome|Placebo Plus Mycophenolate Mofetil Plus Corticosteroids|Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
1095980|NCT00573157|O1|Outcome|Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids|Atacicept was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
1095981|NCT00573157|O2|Outcome|Placebo Plus Mycophenolate Mofetil Plus Corticosteroids|Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
1096011|NCT00573066|O1|Outcome|Dexmedetomidine, Infants, Cardiac Surgery|"Pharmacologic study of dexmedetomidine in infants following cardiac surgery Dexmedetomidine was administered to all subjects as an intravenous loading dose over 10 minutes followed by a continuous infusion for up to 24 hours.~Cohort 1--0.35mcg/kg loading dose, 0.25mcg/kg/hr infusion Cohort 2--0.7 mcg/kg loading dose, 0.5 mcg/kg/hr infusion Cohort 3--1 mcg/kg loading dose, 0.75 mcg/kg/hr infusion"
1099546|NCT00561821|B5|Baseline|Total|Total of all reporting groups
1095982|NCT00573157|O1|Outcome|Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids|Atacicept was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
1095983|NCT00573157|O2|Outcome|Placebo Plus Mycophenolate Mofetil Plus Corticosteroids|Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
1095984|NCT00573157|O1|Outcome|Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids|Atacicept was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
1095985|NCT00573157|E2|Reported Event|Placebo Plus Mycophenolate Mofetil Plus Corticosteroids|Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
1095986|NCT00573157|E1|Reported Event|Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids|Atacicept was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
1095987|NCT00573144|B3|Baseline|Total|Total of all reporting groups
1095988|NCT00573144|B2|Baseline|Nesiritide|Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
1095989|NCT00573144|B1|Baseline|Placebo|Infusion of 72 hours of saline solution (packaged to match active comparator).
1095990|NCT00573144|P2|Participant Flow|Nesiritide|Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
1095991|NCT00573144|P1|Participant Flow|Placebo|Infusion of 72 hours of saline solution (packaged to match active comparator).
1095992|NCT00573144|O2|Outcome|Nesiritide|"Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.~Nesiritide: Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min."
1095993|NCT00573144|O1|Outcome|Placebo|"Infusion of 72 hours of saline solution (packaged to match active comparator).~Placebo: Infusion of 72 hours of saline solution (packaged to match active comparator)"
1096079|NCT00572897|P1|Participant Flow|Sibling Donor|Patients received a stem cell transplant from sibling
1095995|NCT00573144|O1|Outcome|Placebo|"Infusion of 72 hours of saline solution (packaged to match active comparator).~Placebo: Infusion of 72 hours of saline solution (packaged to match active comparator)"
1095996|NCT00573144|O2|Outcome|Nesiritide|"Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.~Nesiritide: Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min."
1095997|NCT00573144|O1|Outcome|Placebo|"Infusion of 72 hours of saline solution (packaged to match active comparator).~Placebo: Infusion of 72 hours of saline solution (packaged to match active comparator)"
1095998|NCT00573144|E2|Reported Event|Nesiritide|Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
1095999|NCT00573144|E1|Reported Event|Placebo|Infusion of 72 hours of saline solution (packaged to match active comparator).
1096000|NCT00573131|B3|Baseline|Total|Total of all reporting groups
1096001|NCT00573131|B2|Baseline|Group 2|Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
1096002|NCT00573131|B1|Baseline|Group 1|OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
1096003|NCT00573131|P2|Participant Flow|Group 2|Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
1096004|NCT00573131|P1|Participant Flow|Group 1|OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
1096005|NCT00573131|O2|Outcome|Group 2|Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
1096006|NCT00573131|O1|Outcome|Group 1|OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
1096007|NCT00573131|E2|Reported Event|Group 2|Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
1096008|NCT00573131|E1|Reported Event|Group 1|OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
1096009|NCT00573066|B1|Baseline|Dexmedetomidine, Infants, Cardiac Surgery|"Pharmacologic study of dexmedetomidine in infants following cardiac surgery Dexmedetomidine was administered to all subjects as an intravenous loading dose over 10 minutes followed by a continuous infusion for up to 24 hours.~Cohort 1--0.35mcg/kg loading dose, 0.25mcg/kg/hr infusion Cohort 2--0.7 mcg/kg loading dose, 0.5 mcg/kg/hr infusion Cohort 3--1 mcg/kg loading dose, 0.75 mcg/kg/hr infusion"
1096010|NCT00573066|P1|Participant Flow|Dexmedetomidine Dose Escalation Cohorts|"Dexmedetomidine was administered to all subjects as an intravenous loading dose over 10 minutes followed by a continuous infusion for up to 24 hours.~Cohort 1--0.35mcg/kg loading dose, 0.25mcg/kg/hr infusion Cohort 2--0.7 mcg/kg loading dose, 0.5 mcg/kg/hr infusion Cohort 3--1 mcg/kg loading dose, 0.75 mcg/kg/hr infusion"
1099706|NCT00561600|B3|Baseline|Total|Total of all reporting groups
1096012|NCT00573066|E1|Reported Event|Dexmedetomidine, Infants, Cardiac Surgery|"Pharmacologic study of dexmedetomidine in infants following cardiac surgery Dexmedetomidine was administered to all subjects as an intravenous loading dose over 10 minutes followed by a continuous infusion for up to 24 hours.~Cohort 1--0.35mcg/kg loading dose, 0.25mcg/kg/hr infusion Cohort 2--0.7 mcg/kg loading dose, 0.5 mcg/kg/hr infusion Cohort 3--1 mcg/kg loading dose, 0.75 mcg/kg/hr infusion"
1096013|NCT00572910|B7|Baseline|Total|Total of all reporting groups
1096014|NCT00572910|B6|Baseline|Placebo (PBO / PBO)|Participants who were vaccinated with Placebo on Day 1 and Day 28.
1096015|NCT00572910|B5|Baseline|V710 (90 mcg / 90 mcg) + MAA|Participants who were vaccinated with V710 (90 mcg with MAA) on Day 1 and Day 28.
1096016|NCT00572910|B4|Baseline|V710 (60 mcg / PBO) + MAA|Participants who were vaccinated with V710 (60 mcg with MAA) on Day 1 and Placebo on Day 28.
1096017|NCT00572910|B3|Baseline|V710 (60 mcg / 60 mcg) + MAA|Participants who were vaccinated with V710 (60 mcg with MAA) on Day 1 and Day 28.
1096018|NCT00572910|B2|Baseline|V710 (60 mcg / PBO)|Participants who were vaccinated with V710 (60 mcg without MAA) on Day 1 and Placebo on Day 28.
1096019|NCT00572910|B1|Baseline|V710 (60 mcg / 60 mcg)|Participants who were vaccinated with V710 (60 mcg without MAA) on Day 1 and Day 28.
1096020|NCT00572910|P11|Participant Flow|Placebo (PBO / PBO / PBO)|Participants in Group 6 who were vaccinated with Placebo (PBO / PBO / PBO).
1096021|NCT00572910|P10|Participant Flow|V710 (90 mcg / 90 mcg / PBO) + MAA|Participants in Group 5B who were vaccinated with V710 (90 mcg / 90 mcg / PBO) with MAA.
1096022|NCT00572910|P9|Participant Flow|V710 (90 mcg / 90 mcg / 90 mcg) + MAA|Participants in Group 5A who were vaccinated with V710 (90 mcg / 90 mcg / 90 mcg) with MAA.
1096023|NCT00572910|P8|Participant Flow|V710 (60 mcg / PBO / PBO) + MAA|Participants in Group 4B who were vaccinated with V710 (60 mcg / PBO / PBO) with MAA.
1096024|NCT00572910|P7|Participant Flow|V710 (60 mcg / PBO / 60 mcg) + MAA|Participants in Group 4A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) with MAA.
1096025|NCT00572910|P6|Participant Flow|V710 (60 mcg / 60 mcg / PBO) + MAA|Participants in Group 3B who were vaccinated with V710 (60 mcg / 60 mcg /PBO) with MAA.
1096026|NCT00572910|P5|Participant Flow|V710 (60 mcg / 60 mcg / 60 mcg) + MAA|Participants in Group 3A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) with MAA.
1096027|NCT00572910|P4|Participant Flow|V710 (60 mcg / PBO / PBO)|Participants in Group 2B who were vaccinated with V710 (60 mcg / PBO / PBO) without MAA.
1096028|NCT00572910|P3|Participant Flow|V710 (60 mcg / PBO / 60 mcg)|Participants in Group 2A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) without MAA.
1096029|NCT00572910|P2|Participant Flow|V710 (60 mcg / 60 mcg / PBO)|Participants in Group 1B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) without MAA.
1096030|NCT00572910|P1|Participant Flow|V710 (60 mcg / 60 mcg / 60 mcg)|Participants in Group 1A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) without MAA.
1096031|NCT00572910|O11|Outcome|Placebo (PBO / PBO / PBO)|Participants in Group 6 who were vaccinated with Placebo (PBO / PBO / PBO).
1096032|NCT00572910|O10|Outcome|V710 (90 mcg / 90 mcg / PBO) + MAA|Participants in Group 5B who were vaccinated with V710 (90 mcg / 90 mcg / PBO) with MAA.
1096033|NCT00572910|O9|Outcome|V710 (90 mcg / 90 mcg / 90 mcg) + MAA|Participants in Group 5A who were vaccinated with V710 (90 mcg / 90 mcg / 90 mcg) with MAA.
1096037|NCT00572910|O5|Outcome|V710 (60 mcg / 60 mcg / 60 mcg) + MAA|Participants in Group 3A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) with MAA.
1096038|NCT00572910|O4|Outcome|V710 (60 mcg / PBO / PBO)|Participants in Group 2B who were vaccinated with V710 (60 mcg / PBO / PBO) without MAA.
1096039|NCT00572910|O3|Outcome|V710 (60 mcg / PBO / 60 mcg)|Participants in Group 2A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) without MAA.
1096040|NCT00572910|O2|Outcome|V710 (60 mcg / 60 mcg / PBO)|Participants in Group 1B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) without MAA.
1096041|NCT00572910|O1|Outcome|V710 (60 mcg / 60 mcg / 60 mcg)|Participants in Group 1A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) without MAA.
1096042|NCT00572910|O11|Outcome|Placebo (PBO / PBO / PBO)|Participants in Group 6 who were vaccinated with Placebo (PBO / PBO / PBO).
1096043|NCT00572910|O10|Outcome|V710 (90 mcg / 90 mcg / PBO) + MAA|Participants in Group 5B who were vaccinated with V710 (90 mcg / 90 mcg / PBO) with MAA.
1096044|NCT00572910|O9|Outcome|V710 (90 mcg / 90 mcg / 90 mcg) + MAA|Participants in Group 5A who were vaccinated with V710 (90 mcg / 90 mcg / 90 mcg) with MAA.
1096045|NCT00572910|O8|Outcome|V710 (60 mcg / PBO / PBO) + MAA|Participants in Group 4B who were vaccinated with V710 (60 mcg / PBO / PBO) with MAA.
1096046|NCT00572910|O7|Outcome|V710 (60 mcg / PBO / 60 mcg) + MAA|Participants in Group 4A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) with MAA.
1096047|NCT00572910|O6|Outcome|V710 (60 mcg / 60 mcg / PBO) + MAA|Participants in Group 3B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) with MAA.
1096048|NCT00572910|O5|Outcome|V710 (60 mcg / 60 mcg / 60 mcg) + MAA|Participants in Group 3A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) with MAA.
1096049|NCT00572910|O4|Outcome|V710 (60 mcg / PBO / PBO)|Participants in Group 2B who were vaccinated with V710 (60 mcg / PBO / PBO) without MAA.
1096050|NCT00572910|O3|Outcome|V710 (60 mcg / PBO / 60 mcg)|Participants in Group 2A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) without MAA.
1096051|NCT00572910|O2|Outcome|V710 (60 mcg / 60 mcg / PBO)|Participants in Group 1B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) without MAA.
1096052|NCT00572910|O1|Outcome|V710 (60 mcg / 60 mcg / 60 mcg)|Participants in Group 1A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) without MAA.
1096053|NCT00572910|O2|Outcome|V710 - Group 4|Participants in Group 4 were vaccinated V710 (60 mcg with MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180.
1096054|NCT00572910|O1|Outcome|V710 - Group 2|Participants in Group 2 were vaccinated V710 (60 mcg without MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180.
1096055|NCT00572910|O3|Outcome|V710 - Group 5|Participants in Group 5 were vaccinated V710 (90 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
1096056|NCT00572910|O2|Outcome|V710 - Group 3|Participants in Group 2 were vaccinated V710 (60 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
1096121|NCT00572624|O1|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
1096057|NCT00572910|O1|Outcome|V710 - Group 1|Participants in Group 1 were vaccinated V710 (60 mcg without MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
1096058|NCT00572910|O3|Outcome|V710 - Group 5|Participants in Group 5 were vaccinated with V710 (90 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
1096059|NCT00572910|O2|Outcome|V710 - Group 3 and 4|"Participants in Group 3 were vaccinated with V710 (60 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.~Participants in Group 4 were vaccinated with V710 (60 mcg with MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180."
1096060|NCT00572910|O1|Outcome|V710 - Group 1 and 2|"Participants in Group 1 were vaccinated with V710 (60 mcg without MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.~Participants Group 2 were vaccinated with V710 (60 mcg without MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180."
1096061|NCT00572910|O3|Outcome|V710 (90 mcg With MAA) - Group 5|Participants in Group 5 were vaccinated with V710 (90 mcg with MAA) on Day 1 and Day 28.
1096062|NCT00572910|O2|Outcome|V710 (60 mcg With MAA) - Group 3|Participants in Group 3 were vaccinated with V710 (60 mcg with MAA) on Day 1 and Day 28.
1096063|NCT00572910|O1|Outcome|V710 (60 mcg Without MAA) - Group 1|Participants in Group 1 were vaccinated with V710 (60 mcg without MAA) on Day 1 and Day 28.
1096064|NCT00572910|E11|Reported Event|Placebo (PBO / PBO / PBO)|Participants in Group 6 who were vaccinated with Placebo (PBO / PBO / PBO).
1096065|NCT00572910|E10|Reported Event|V710 (90 mcg / 90 mcg / PBO) + MAA|Participants in Group 5B who were vaccinated with V710 (90 mcg / 90 mcg / PBO) with MAA.
1096066|NCT00572910|E9|Reported Event|V710 (90 mcg / 90 mcg / 90 mcg) + MAA|Participants in Group 5A who were vaccinated with V710 (90 mcg / 90 mcg / 90 mcg) with MAA.
1096067|NCT00572910|E8|Reported Event|V710 (60 mcg / PBO / PBO) + MAA|Participants in Group 4B who were vaccinated with V710 (60 mcg / PBO / PBO) with MAA.
1096068|NCT00572910|E7|Reported Event|V710 (60 mcg / PBO / 60 mcg) + MAA|Participants in Group 4A who were vaccinated with V710 (60 mcg / PBO / PBO) with MAA.
1096069|NCT00572910|E6|Reported Event|V710 (60 mcg / 60 mcg / PBO) + MAA|Participants in Group 3B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) with MAA.
1096070|NCT00572910|E5|Reported Event|V710 (60 mcg / 60 mcg / 60 mcg) + MAA|Participants in Group 3A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) with MAA.
1096071|NCT00572910|E4|Reported Event|V710 (60 mcg / PBO / PBO)|Participants in Group 2B who were vaccinated with V710 (60 mcg / PBO / PBO) without MAA.
1096072|NCT00572910|E3|Reported Event|V710 (60 mcg / PBO / 60 mcg)|Participants in Group 2A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) without MAA.
1096073|NCT00572910|E2|Reported Event|V710 (60 mcg / 60 mcg / PBO)|Participants in Group 1B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) without MAA.
1096074|NCT00572910|E1|Reported Event|V710 (60 mcg / 60 mcg / 60 mcg)|Participants in Group 1A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) without MAA.
1096075|NCT00572897|B3|Baseline|Total|Total of all reporting groups
1096076|NCT00572897|B2|Baseline|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
1096077|NCT00572897|B1|Baseline|Sibling Donor|Patients received a stem cell transplant from sibling
1096078|NCT00572897|P2|Participant Flow|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
1096082|NCT00572897|O2|Outcome|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
1096083|NCT00572897|O1|Outcome|Sibling Donor|Patients received a stem cell transplant from sibling
1096084|NCT00572897|O2|Outcome|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
1096085|NCT00572897|O1|Outcome|Sibling Donor|Patients received a stem cell transplant from sibling
1096086|NCT00572897|O2|Outcome|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
1096087|NCT00572897|O1|Outcome|Sibling Donor|Patients received a stem cell transplant from sibling
1096088|NCT00572897|O2|Outcome|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
1096089|NCT00572897|O1|Outcome|Sibling Donor|Patients received a stem cell transplant from sibling
1096090|NCT00572897|O2|Outcome|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
1096091|NCT00572897|O1|Outcome|Sibling Donor|Patients received a stem cell transplant from sibling
1096092|NCT00572897|E2|Reported Event|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
1096093|NCT00572897|E1|Reported Event|Sibling Donor|Patients received a stem cell transplant from sibling
1096094|NCT00572832|B3|Baseline|Total|Total of all reporting groups
1096095|NCT00572832|B2|Baseline|12 Month Alternative Group|12 month Alternative Schedule Group with 3 doses of quadrivalent vaccine at 0, 2, and 12 months
1096096|NCT00572832|B1|Baseline|6 Month Standard Schedule|Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.
1096097|NCT00572832|P2|Participant Flow|12 Month Alternative Group|12 month Alternative Schedule Group with 3 doses of quadrivalent vaccine at 0, 2, and 12 months
1096098|NCT00572832|P1|Participant Flow|6 Month Standard Schedule|Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.
1096099|NCT00572832|O2|Outcome|12 Month Alternative Group|12 month Alternative Schedule Group with 3 doses of quadrivalent vaccine at 0, 2, and 12 months
1096100|NCT00572832|O1|Outcome|6 Month Standard Schedule|Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.
1096101|NCT00572832|E2|Reported Event|12 Month Alternative Group|12 month Alternative Schedule Group with 3 doses of quadrivalent vaccine at 0, 2, and 12 months
1096102|NCT00572832|E1|Reported Event|6 Month Standard Schedule|Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.
1096122|NCT00572624|O2|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
1096123|NCT00572624|O1|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
1096124|NCT00572624|O2|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
1096165|NCT00572533|B1|Baseline|Control|ESA Dose Adjustment per standard Anemia Management Protocol
1096103|NCT00572728|B1|Baseline|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
1096104|NCT00572728|P1|Participant Flow|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
1096105|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
1096106|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
1096107|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET /CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~CT: Undergo 18F-FLT PET/CT~18F-FLT: Undergo 18F-FLT PET/CT~PET: Undergo 18F-FLT PET/CT"
1096108|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
1096109|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
1096110|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
1096111|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post-NAC (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
1096112|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
1096113|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
1096114|NCT00572728|E1|Reported Event|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
1096115|NCT00572624|B3|Baseline|Total|Total of all reporting groups
1096116|NCT00572624|B2|Baseline|Gastric Bypass Surgery|Participants who received gastric bypass surgery
1096117|NCT00572624|B1|Baseline|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
1096118|NCT00572624|P2|Participant Flow|Gastric Bypass Surgery|Participants who received gastric bypass surgery
1096119|NCT00572624|P1|Participant Flow|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
1096120|NCT00572624|O2|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
1096125|NCT00572624|O1|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
1096126|NCT00572624|O2|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
1096127|NCT00572624|O1|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
1096128|NCT00572624|O2|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
1096129|NCT00572624|O1|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
1096130|NCT00572624|O2|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
1096131|NCT00572624|O1|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
1096132|NCT00572624|O2|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
1096133|NCT00572624|O1|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
1096134|NCT00572624|O2|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
1096135|NCT00572624|O1|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
1096136|NCT00572624|O2|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
1096137|NCT00572624|O1|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
1096138|NCT00572624|O2|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
1096139|NCT00572624|O1|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
1096140|NCT00572624|O2|Outcome|Gastric Bypass Surgery|Participants who received gastric bypass surgery
1096141|NCT00572624|O1|Outcome|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
1096142|NCT00572624|E2|Reported Event|Gastric Bypass Surgery|Participants who received gastric bypass surgery
1096143|NCT00572624|E1|Reported Event|Diet|Participants who received counseling and instruction about weight loss through diet and exercise
1096144|NCT00572572|B3|Baseline|Total|Total of all reporting groups
1096145|NCT00572572|B2|Baseline|Arm B: Placebo, Then Aprepitant|"Participants first received matched placebo PO daily on days 3 through 7 during study cycle 1, then received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 2~Aprepitant: Subjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2.~Placebo: Subjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2."
1096146|NCT00572572|B1|Baseline|Arm A: Aprepitant, Then Placebo|"Participants first received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 1, then received matched placebo PO daily on days 3 through 7 during study cycle 2~Aprepitant: Subjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2.~Placebo: Subjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2."
1096195|NCT00572156|P4|Participant Flow|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
1099675|NCT00561678|O2|Outcome|Placebo|Placebo - normal saline 0.5/ug/kg/hr
1096147|NCT00572572|P2|Participant Flow|Arm B: Placebo, Then Aprepitant|"Participants first received matched placebo PO daily on days 3 through 7 during study cycle 1, then received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 2~Aprepitant: Subjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2.~Placebo: Subjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2."
1096148|NCT00572572|P1|Participant Flow|Arm A: Aprepitant, Then Placebo|"Participants first received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 1, then received matched placebo PO daily on days 3 through 7 during study cycle 2~Aprepitant: Subjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2.~Placebo: Subjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2."
1096149|NCT00572572|O2|Outcome|Placebo|Placebo cycle whether placebo then aprepitant or aprepitant then placebo
1096150|NCT00572572|O1|Outcome|Aprepitant|Aprepitant cycle whether aprepitant then placebo or placebo then aprepitant
1096151|NCT00572572|O2|Outcome|Placebo|Placebo cycle whether placebo then aprepitant or aprepitant then placebo
1096152|NCT00572572|O1|Outcome|Aprepitant|Aprepitant cycle whether aprepitant then placebo or placebo then aprepitant
1096153|NCT00572572|O2|Outcome|Placebo|Placebo cycle whether placebo then aprepitant or aprepitant then placebo
1096154|NCT00572572|O1|Outcome|Aprepitant|Aprepitant cycle whether aprepitant then placebo or placebo then aprepitant
1096155|NCT00572572|O2|Outcome|Placebo|Placebo cycle whether placebo then aprepitant or aprepitant then placebo
1096156|NCT00572572|O1|Outcome|Aprepitant|Aprepitant cycle whether aprepitant then placebo or placebo then aprepitant
1096157|NCT00572572|O2|Outcome|Placebo|Placebo cycle whether placebo then aprepitant or aprepitant then placebo
1096158|NCT00572572|O1|Outcome|Aprepitant|Aprepitant cycle whether aprepitant then placebo or placebo then aprepitant
1096159|NCT00572572|O2|Outcome|Placebo|Placebo cycle whether placebo then aprepitant or aprepitant then placebo
1096160|NCT00572572|O1|Outcome|Aprepitant|Aprepitant cycle whether aprepitant then placebo or placebo then aprepitant
1096161|NCT00572572|E2|Reported Event|Placebo, Then Aprepitant.|"Arm A, Study Cycle 2~Arm B, Study Cycle 1~Placebo: Matched placebo PO daily on days 3 through 7~Subjects will be stratified prior to randomization based on previous administration of chemotherapy.~Subjects will randomize to aprepitant versus placebo with their first study cycle of chemotherapy and then cross over to opposite arm with the second study cycle.~Arm A, Study Cycle 2~Arm B, Study Cycle 1"
1096162|NCT00572572|E1|Reported Event|Aprepitant, Then Placebo|"Arm A, Study Cycle 1~Arm B, Study Cycle 2~Aprepitant: Aprepitant 125mg PO day 3 then 80mg on days 4 through 7~Subjects will be stratified prior to randomization based on previous administration of chemotherapy.~Subjects will randomize to aprepitant versus placebo with their first study cycle of chemotherapy and then cross over to opposite arm with the second study cycle.~Arm A, Study Cycle 1~Arm B, Study Cycle 2"
1096163|NCT00572533|B3|Baseline|Total|Total of all reporting groups
1096166|NCT00572533|P2|Participant Flow|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
1096167|NCT00572533|P1|Participant Flow|Control|ESA Dose Adjustment per standard Anemia Management Protocol
1096168|NCT00572533|O2|Outcome|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
1096169|NCT00572533|O1|Outcome|Control|ESA Dose Adjustment per standard Anemia Management Protocol
1096170|NCT00572533|O2|Outcome|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
1096171|NCT00572533|O1|Outcome|Control|ESA Dose Adjustment per standard Anemia Management Protocol
1096172|NCT00572533|O2|Outcome|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
1096173|NCT00572533|O1|Outcome|Control|ESA Dose Adjustment per standard Anemia Management Protocol
1096174|NCT00572533|O2|Outcome|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
1096175|NCT00572533|O1|Outcome|Control|ESA Dose Adjustment per standard Anemia Management Protocol
1096176|NCT00572533|O2|Outcome|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
1096177|NCT00572533|O1|Outcome|Control|ESA Dose Adjustment per standard Anemia Management Protocol
1096178|NCT00572533|O2|Outcome|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
1096179|NCT00572533|O1|Outcome|Control|ESA Dose Adjustment per standard Anemia Management Protocol
1096180|NCT00572533|O2|Outcome|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
1096181|NCT00572533|O1|Outcome|Control|ESA Dose Adjustment per standard Anemia Management Protocol
1096182|NCT00572533|O2|Outcome|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
1096183|NCT00572533|O1|Outcome|Control|ESA Dose Adjustment per standard Anemia Management Protocol
1096184|NCT00572533|E2|Reported Event|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
1096185|NCT00572533|E1|Reported Event|Control|ESA Dose Adjustment per standard Anemia Management Protocol
1096186|NCT00572260|B1|Baseline|Antimicrobial Prophylaxis Administration With Daptomycin|
1096187|NCT00572260|P1|Participant Flow|Antimicrobial Prophylaxis Administration With Daptomycin|
1096188|NCT00572260|O1|Outcome|Patients Undergoing Cardiac Surgery|Patients undergoing cardiac valve replacement and coronary artery bypass grafting
1096189|NCT00572260|E1|Reported Event|Antimicrobial Prophylaxis Administration With Daptomycin|
1096190|NCT00572156|B5|Baseline|Total|Total of all reporting groups
1096191|NCT00572156|B4|Baseline|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
1096192|NCT00572156|B3|Baseline|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
1096193|NCT00572156|B2|Baseline|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
1096194|NCT00572156|B1|Baseline|45 rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
1096196|NCT00572156|P3|Participant Flow|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
1096197|NCT00572156|P2|Participant Flow|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and Recombinant Human Insulin-Like Growth Factor-1 (rhIGF-1) (Mecasermin) 50µg/kg once daily injections
1096198|NCT00572156|P1|Participant Flow|45 rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): Recombinant Human Growth Hormone (rhGH) (Somatropin) 45µg/kg once daily injection
1096199|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
1096200|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
1096201|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
1096202|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
1096203|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
1096204|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
1096205|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
1096206|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
1096207|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
1096208|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
1096209|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
1096210|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
1096211|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
1096212|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
1096521|NCT00570778|O4|Outcome|Placebo|Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
1096213|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
1096214|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
1096215|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
1096216|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
1096217|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
1096218|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
1096219|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
1096220|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
1096221|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
1096222|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
1096223|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
1096224|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
1096225|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
1096226|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
1096227|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
1096228|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
1096229|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
1096230|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
1096231|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
1096232|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
1096233|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
1096234|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
1096235|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
1096236|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
1096237|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
1096238|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
1096239|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
1096240|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
1096241|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
1096242|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
1096243|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
1096244|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
1096245|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
1096246|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
1096247|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
1096248|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
1097024|NCT00569803|O1|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
1096249|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
1096250|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
1096251|NCT00572156|E4|Reported Event|4. 45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
1096252|NCT00572156|E3|Reported Event|3. 45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
1096253|NCT00572156|E2|Reported Event|2. 45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
1096254|NCT00572156|E1|Reported Event|1. rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
1096255|NCT00572117|B3|Baseline|Total|Total of all reporting groups
1096256|NCT00572117|B2|Baseline|Placebo (Inert Pill) Arm|"Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. Subjects will receive placebo pills identical to the active pills (pills that contain the study drug, topiramate) for the 12 treatment weeks of the study and will have the pills discontinued over the next four weeks of the study. All subjects will be re-evaluated at 26 and 52 weeks.~Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study."
1096257|NCT00572117|B1|Baseline|Topiramate|"Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. The pills will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.~Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study."
1096258|NCT00572117|P2|Participant Flow|Placebo (Inert Pill) Arm|"Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. Subjects will receive placebo pills identical to the active pills (pills that contain the study drug, topiramate) for the 12 treatment weeks of the study and will have the pills discontinued over the next four weeks of the study. All subjects will be re-evaluated at 26 and 52 weeks.~Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study."
1096278|NCT00572039|O1|Outcome|Problem Solving Treatment|"Problem Solving Treatment (PST)~PST: PST will be delivered in subjects' homes over the course of 6 weeks."
1097098|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
1096259|NCT00572117|P1|Participant Flow|Topiramate|"Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. The pills will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.~Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study."
1096260|NCT00572117|O2|Outcome|Placebo (Inert Pill) Arm|Change in HAM-D score from baseline
1096261|NCT00572117|O1|Outcome|Topiramate|Change in HAM-D score from baseline
1096262|NCT00572117|O2|Outcome|Placebo (Inert Pill) Arm|Change in average number of drinks/heavy drinking day
1096263|NCT00572117|O1|Outcome|Topiramate|Change in average number of drinks/heavy drinking day
1096264|NCT00572117|E2|Reported Event|Placebo (Inert Pill) Arm|"Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. Subjects will receive placebo pills identical to the active pills (pills that contain the study drug, topiramate) for the 12 treatment weeks of the study and will have the pills discontinued over the next four weeks of the study. All subjects will be re-evaluated at 26 and 52 weeks.~Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study."
1096265|NCT00572117|E1|Reported Event|Topiramate|"Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. The pills will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.~Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study."
1096266|NCT00572039|B3|Baseline|Total|Total of all reporting groups
1096267|NCT00572039|B2|Baseline|Supportive Therapy|"Supportive Therapy (ST)~ST: ST will be delivered in subjects' homes over the course of 6 weeks."
1096268|NCT00572039|B1|Baseline|Problem Solving Treatment|"Problem Solving Treatment (PST)~PST: PST will be delivered in subjects' homes over the course of 6 weeks."
1096354|NCT00571649|B1|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days (SAF population)
1096269|NCT00572039|P2|Participant Flow|Supportive Therapy|Supportive therapy is a structured, standardized, psychological treatment that controls for nonspecific treatment effects. Supportive therapy resembles PST in all ways but for PST’s problem-solving skills training. Both interventions are based on written treatment manuals and similar in dose and intensity of attention (number and duration of sessions). Supportive therapy is nondirective and supportive, facilitates personal expression, and conveys empathy, respect, and optimism (i.e., a general sense that things can get better). The ST therapist informs subjects that ST’s purpose is to explore the impact of vision loss on their lives.
1096270|NCT00572039|P1|Participant Flow|Problem Solving Treatment|Problem-solving therapy teaches problem solving skills in a structured way to enable a patient to systematically identify his or her problems, generate alternative solutions for each problem, select the best solution, develop and conduct a plan, and evaluate whether the problem is solved.
1096271|NCT00572039|O2|Outcome|Supportive Therapy|Supportive therapy is a structured, standardized, psychological treatment that controls for nonspecific treatment effects. Supportive therapy resembles PST in all ways but for PST’s problem-solving skills training. Both interventions are based on written treatment manuals and similar in dose and intensity of attention (number and duration of sessions). Supportive therapy is nondirective and supportive, facilitates personal expression, and conveys empathy, respect, and optimism (i.e., a general sense that things can get better). The ST therapist informs subjects that ST’s purpose is to explore the impact of vision loss on their lives.
1096272|NCT00572039|O1|Outcome|Problem Solving Treatment|Problem-solving therapy teaches problem solving skills in a structured way to enable a patient to systematically identify his or her problems, generate alternative solutions for each problem, select the best solution, develop and conduct a plan, and evaluate whether the problem is solved.
1096273|NCT00572039|O2|Outcome|Supportive Therapy|Supportive therapy is a structured, standardized, psychological treatment that controls for nonspecific treatment effects. Supportive therapy resembles PST in all ways but for PST’s problem-solving skills training. Both interventions are based on written treatment manuals and similar in dose and intensity of attention (number and duration of sessions). Supportive therapy is nondirective and supportive, facilitates personal expression, and conveys empathy, respect, and optimism (i.e., a general sense that things can get better). The ST therapist informs subjects that ST’s purpose is to explore the impact of vision loss on their lives.
1096274|NCT00572039|O1|Outcome|Problem Solving Treatment|Problem-solving therapy teaches problem solving skills in a structured way to enable a patient to systematically identify his or her problems, generate alternative solutions for each problem, select the best solution, develop and conduct a plan, and evaluate whether the problem is solved.
1096275|NCT00572039|O2|Outcome|Supportive Therapy|Supportive therapy is a structured, standardized, psychological treatment that controls for nonspecific treatment effects. Supportive therapy resembles PST in all ways but for PST’s problem-solving skills training. Both interventions are based on written treatment manuals and similar in dose and intensity of attention (number and duration of sessions). Supportive therapy is nondirective and supportive, facilitates personal expression, and conveys empathy, respect, and optimism (i.e., a general sense that things can get better). The ST therapist informs subjects that ST’s purpose is to explore the impact of vision loss on their lives.
1096276|NCT00572039|O1|Outcome|Problem Solving Treatment|Problem-solving therapy teaches problem solving skills in a structured way to enable a patient to systematically identify his or her problems, generate alternative solutions for each problem, select the best solution, develop and conduct a plan, and evaluate whether the problem is solved.
1096277|NCT00572039|O2|Outcome|Supportive Therapy|"Supportive Therapy (ST)~ST: ST will be delivered in subjects' homes over the course of 6 weeks."
1096279|NCT00572039|E2|Reported Event|Supportive Therapy|Supportive therapy is a structured, standardized, psychological treatment that controls for nonspecific treatment effects. Supportive therapy resembles PST in all ways but for PST’s problem-solving skills training. Both interventions are based on written treatment manuals and similar in dose and intensity of attention (number and duration of sessions). Supportive therapy is nondirective and supportive, facilitates personal expression, and conveys empathy, respect, and optimism (i.e., a general sense that things can get better). The ST therapist informs subjects that ST’s purpose is to explore the impact of vision loss on their lives.
1096280|NCT00572039|E1|Reported Event|Problem Solving Treatment|Problem-solving therapy teaches problem solving skills in a structured way to enable a patient to systematically identify his or her problems, generate alternative solutions for each problem, select the best solution, develop and conduct a plan, and evaluate whether the problem is solved.
1096281|NCT00571987|B1|Baseline|RFA Treatment|AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
1096282|NCT00571987|P1|Participant Flow|Subjects Received RFA Treatment|AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
1096283|NCT00571987|O1|Outcome|Recurrences at the Site|AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
1096284|NCT00571987|O1|Outcome|Margin Status|AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
1096285|NCT00571987|E1|Reported Event|RFA Treatment|AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
1096286|NCT00571974|B3|Baseline|Total|Total of all reporting groups
1096355|NCT00571649|P2|Participant Flow|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days during treatment period
1096287|NCT00571974|B2|Baseline|Phase II|During Phase II, to assess the treatment efficacy of PDL-585 when used at the MTD in combination with 5-ALA applied topically to the premalignant lesion. Treatment efficacy will be assessed by means of the 90-day Objective Response rate observed among study subjects treated at the MTD.
1096288|NCT00571974|B1|Baseline|Phase I|"To determine the maximum tolerated energy density of the Pulse Dye Laser operated at 585 nm with a pulse time of 1.5 ms (PDL-585), when used in combination with 5-aminolevulinic acid (5-ALA) applied topically to the premalignant lesion.~The maximum tolerated energy density will be called the Maximum Tolerated Dose (MTD)."
1096289|NCT00571974|P2|Participant Flow|Phase II|During Phase II, to assess the treatment efficacy of PDL-585 when used at the MTD in combination with 5-ALA applied topically to the premalignant lesion. Treatment efficacy will be assessed by means of the 90-day Objective Response rate observed among study subjects treated at the MTD.
1096290|NCT00571974|P1|Participant Flow|Phase I|"To determine the maximum tolerated energy density of the Pulse Dye Laser operated at 585 nm with a pulse time of 1.5 ms (PDL-585), when used in combination with 5-aminolevulinic acid (5-ALA) applied topically to the premalignant lesion.~The maximum tolerated energy density will be called the Maximum Tolerated Dose (MTD)."
1096291|NCT00571974|O1|Outcome|Phase II|Subjects treated with the MTD.
1096292|NCT00571974|O1|Outcome|Phase I|Participants in the Phase I part of the study.
1096293|NCT00571974|E2|Reported Event|Phase II|During Phase II, to assess the treatment efficacy of PDL-585 when used at the MTD in combination with 5-ALA applied topically to the premalignant lesion. Treatment efficacy will be assessed by means of the 90-day Objective Response rate observed among study subjects treated at the MTD.
1096294|NCT00571974|E1|Reported Event|Phase I|"To determine the maximum tolerated energy density of the Pulse Dye Laser operated at 585 nm with a pulse time of 1.5 ms (PDL-585), when used in combination with 5-aminolevulinic acid (5-ALA) applied topically to the premalignant lesion.~The maximum tolerated energy density will be called the Maximum Tolerated Dose (MTD)."
1096295|NCT00571961|B1|Baseline|Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg|Subjects received 800mg/200mg of LPV/r in addition to BUP/NLX that the subjects were already being previously maintained on. These drugs were coadministered for a minimum of 10 days under direct observation.
1096296|NCT00571961|P1|Participant Flow|Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg|Subjects received 800mg/200mg of LPV/r once daily in addition to BUP/NLX that the subjects were already being previously maintained on. These drugs were coadministered for a minimum of 10 days under direct observation.
1096297|NCT00571961|O1|Outcome|Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg|Subjects received 800mg/200mg of LPV/r in addition to BUP/NLX that the subjects were already being previously maintained on. These drugs were coadministered for a minimum of 10 days under direct observation.
1096298|NCT00571961|E1|Reported Event|Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg|Subjects received 800mg/200mg of LPV/r in addition to BUP/NLX that the subjects were already being previously maintained on. These drugs were coadministered for a minimum of 10 days under direct observation.
1096299|NCT00571948|B3|Baseline|Total|Total of all reporting groups
1096300|NCT00571948|B2|Baseline|Participants in the Intervention Group|Infants in the intervention group received vegetable-potato-meat-meals as part of complementary food containing higher amounts of meat than the control group and rapeseed oil instead of corn oil.
1096301|NCT00571948|B1|Baseline|Participants in the Control Group|Infants in the control group received vegetable-potato-meat-meals as part of complementary food containing common amounts of meat and corn oil marketed in Germany.
1096302|NCT00571948|P2|Participant Flow|Participants in the Intervention Group|Infants in the intervention group received vegetable-potato-meat-meals as part of complementary food containing higher amounts of meat than the control group and rapeseed oil instead of corn oil.
1097099|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
1096303|NCT00571948|P1|Participant Flow|Participants in the Control Group|Infants in the control group received vegetable-potato-meat-meals as part of complementary food containing common amounts of meat and corn oil marketed in Germany.
1096304|NCT00571948|O2|Outcome|Participants in the Intervention Group|Infants in the intervention group received vegetable-potato-meat-meals as part of complementary food containing higher amounts of meat than the control group and rapeseed oil instead of corn oil.
1096305|NCT00571948|O1|Outcome|Participants in the Control Group|Infants in the control group received vegetable-potato-meat-meals as part of complementary food containing common amounts of meat and corn oil marketed in Germany.
1096306|NCT00571948|E2|Reported Event|Participants in the Intervention Group|Infants in the intervention group received vegetable-potato-meat-meals as part of complementary food containing higher amounts of meat than the control group and rapeseed oil instead of corn oil.
1096307|NCT00571948|E1|Reported Event|Participants in the Control Group|Infants in the control group received vegetable-potato-meat-meals as part of complementary food containing common amounts of meat and corn oil marketed in Germany.
1096308|NCT00571922|B3|Baseline|Total|Total of all reporting groups
1096309|NCT00571922|B2|Baseline|Placebo|placebo: matching placebo
1096310|NCT00571922|B1|Baseline|Acamprosate|Acamprosate: 2 gr/day (333 mg, TID)
1096311|NCT00571922|P2|Participant Flow|Placebo|placebo: matching placebo
1096312|NCT00571922|P1|Participant Flow|Acamprosate|Acamprosate: 2 gr/day (333 mg, TID)
1096313|NCT00571922|O2|Outcome|Placebo|placebo: matching placebo
1096314|NCT00571922|O1|Outcome|Acamprosate|Acamprosate: 2 gr/day (333 mg, TID)
1096315|NCT00571922|O2|Outcome|Placebo|placebo: matching placebo
1096316|NCT00571922|O1|Outcome|Acamprosate|Acamprosate: 2 gr/day (333 mg, TID)
1096317|NCT00571922|E2|Reported Event|Placebo|placebo: matching placebo
1096318|NCT00571922|E1|Reported Event|Acamprosate|Acamprosate: 2 gr/day (333 mg, TID)
1096319|NCT00571701|B3|Baseline|Total|Total of all reporting groups
1096320|NCT00571701|B2|Baseline|Placebo First, Then Celecoxib|"Patients randomized to start placebo 6 months after enrollment. One placebo capsule will be taken orally once a day. Placebo will match appearance of active celecoxib capsules. Cross over to 12 months of treatment with celecoxib after 1 year.~celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight >25 kg"
1097605|NCT00567840|O2|Outcome|PA-824 600 mg|PA-824: 600 mg per day for 14 consecutive days
1096321|NCT00571701|B1|Baseline|Celecoxib First, Then Placebo|"Patients randomized to start celecoxib 6 months after enrollment. Then cross over to placebo after 1 year. Celecoxib dosing will be given orally 400mg once a day for adults, 200 mg once a day for pediatric patients between 12-25kg, 100mg once a day for pediatric patients < 12kg~celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight >25 kg"
1096322|NCT00571701|P2|Participant Flow|Placebo First (12 Months), Then Celecoxib (12 Months)|"Patients randomized to start placebo 6 months after enrollment. One placebo capsule will be taken orally once a day. Placebo will match appearance of active celecoxib capsules. Cross over to 12 months of treatment with celecoxib after 1 year.~celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight >25 kg"
1096323|NCT00571701|P1|Participant Flow|Celecoxib First (12 Months), Then Placebo (12 Months)|"Patients randomized to start celecoxib 6 months after enrollment. Then cross over to placebo after 1 year. Celecoxib dosing will be given orally 400mg once a day for adults, 200 mg once a day for pediatric patients between 12-25kg, 100mg once a day for pediatric patients < 12kg~celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight >25 kg"
1096324|NCT00571701|O2|Outcome|Celecoxib Responders- Not Maintained|Subjects randomized to celecoxib first with response greater than 50% at end of first treatment period whose papilloma growth rate worsened by more than 0.01 at end of second treatment period.
1096325|NCT00571701|O1|Outcome|Celecoxib Responders-maintained|Subjects randomized to celecoxib first with response greater than 50% at end of first treatment period that maintained response at end of second treatment.
1096326|NCT00571701|O2|Outcome|Non-responders|Subjects randomized to celecoxib first with response less than 50% at end of first treatment period relative to mean disease severity prior to treatment.
1096327|NCT00571701|O1|Outcome|Responders|Subjects randomized to celecoxib first with response greater than 50% at end of first treatment period relative to mean disease severity prior to treatment.
1096328|NCT00571701|O4|Outcome|Placebo First- HPV 11|Subjects infected with HPV 11 treated with placebo during the first treatment period
1096329|NCT00571701|O3|Outcome|Celecoxib First- HPV 11|Subjects infected with HPV 11 treated with celecoxib during the first treatment period
1096330|NCT00571701|O2|Outcome|Placebo First- HPV 6|Subjects infected with HPV 6 treated with placebo during first treatment period
1096331|NCT00571701|O1|Outcome|Celecoxib First - HPV 6|Subjects infected with HPV 6 treated with celecoxib during the first treatment period
1096332|NCT00571701|O4|Outcome|Placebo First- Adult-onset|Adult-onset subjects treated with placebo during the first treatment
1096333|NCT00571701|O3|Outcome|Celecoxib First - Adult Onset|Adult-onset subjects treated with celecoxib during the first treatment period
1096334|NCT00571701|O2|Outcome|Placebo First- Juvenile-onsent|Juvenile-onset subjects treated with placebo during first treatment period
1096335|NCT00571701|O1|Outcome|Celecoxib First- Juvenile Onset|Juvenile-onset subjects treated with celecoxib during the first treatment period
1096336|NCT00571701|O4|Outcome|Placebo First- Females|Females treated with placebo during the first treatment period
1096337|NCT00571701|O3|Outcome|Celecoxib First- Females|Females treated with celecoxib during the first treatment period
1096338|NCT00571701|O2|Outcome|Placebo First- Males|Males treated with placebo during the first treatment period
1096339|NCT00571701|O1|Outcome|Celecoxib First - Males|Males treated with celecoxib during the first treatment period
1096340|NCT00571701|O2|Outcome|Placebo First (12 Months), Then Celecoxib (12 Months)|"Patients randomized to start placebo 6 months after enrollment. One placebo capsule will be taken orally once a day. Placebo will match appearance of active celecoxib capsules. Cross over to 12 months of treatment with celecoxib after 1 year.~celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight >25 kg"
1097100|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
1096341|NCT00571701|O1|Outcome|Celecoxib First (12 Months), Then Placebo (12 Months)|"Patients randomized to start celecoxib 6 months after enrollment. Then cross over to placebo after 1 year. Celecoxib dosing will be given orally 400mg once a day for adults, 200 mg once a day for pediatric patients between 12-25kg, 100mg once a day for pediatric patients < 12kg~celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight >25 kg"
1096342|NCT00571701|O2|Outcome|Placebo First, Then Celecoxib|"Patients randomized to start placebo. One placebo capsule will be taken orally once a day. Placebo will match appearance of active celecoxib capsules. Cross over to 12 months of treatment with celecoxib after 1 year.~celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight >25 kg"
1096343|NCT00571701|O1|Outcome|Celecoxib First, Then Placebo|"Patients randomized to start celecoxib. Then cross over to placebo after 1 year. Celecoxib dosing will be given orally 400mg once a day for adults, 200 mg once a day for pediatric patients between 12-25kg, 100mg once a day for pediatric patients < 12kg~celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight >25 kg"
1096344|NCT00571701|E2|Reported Event|Placebo|Patients who received placebo for 12 months during either time period
1096345|NCT00571701|E1|Reported Event|Celecoxib|Patients who received celecoxib for 12 months during either time period
1096346|NCT00571662|B1|Baseline|Cohort I|Pentostatin to be administered intravenously on days -10, -9, and -8 at a dose of 4mg/m2/day
1096347|NCT00571662|P1|Participant Flow|Cohort I|Pentostatin to be administered intravenously on days -10, -9, and -8 at a dose of 4mg/m2/day
1096348|NCT00571662|O1|Outcome|Cohort I|Pentostatin to be administered intravenously on days -10, -9, and -8 at a dose of 4mg/m2/day
1096349|NCT00571662|O1|Outcome|Cohort I|Pentostatin to be administered intravenously on days -10, -9, and -8 at a dose of 4mg/m2/day
1096350|NCT00571662|O1|Outcome|Cohort I|Pentostatin to be administered intravenously on days -10, -9, and -8 at a dose of 4mg/m2/day
1096351|NCT00571662|E1|Reported Event|Cohort I|Pentostatin to be administered intravenously on days -10, -9, and -8 at a dose of 4mg/m2/day
1096352|NCT00571649|B3|Baseline|Total|Total of all reporting groups
1096353|NCT00571649|B2|Baseline|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days (SAF population)
1096356|NCT00571649|P1|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days during treatment period
1096357|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
1096358|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
1096359|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
1096360|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
1096361|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
1096362|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
1096363|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
1096364|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
1096365|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
1096366|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
1096367|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
1096368|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
1096369|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
1096370|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
1096371|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
1096372|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
1096373|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
1096602|NCT00570739|O3|Outcome|Pre-Diabetes Group: Placebo (LOCF)|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096374|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
1096375|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
1096376|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
1096377|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
1096378|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
1096379|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
1096380|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
1096381|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
1096382|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
1096383|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
1096384|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
1096385|NCT00571649|E2|Reported Event|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
1096386|NCT00571649|E1|Reported Event|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
1096387|NCT00571428|B3|Baseline|Total|Total of all reporting groups
1096388|NCT00571428|B2|Baseline|30 Mcg QD / 15 Mcg BID|Arformoterol 30 mcg once a day (morning) and placebo (evening) for one visit followed by Arformoterol 15 mcg twice a day (morning and evening) for the next visit.
1099708|NCT00561600|B1|Baseline|ASR XL|ASR™-XL Acetabular Cup System
1096389|NCT00571428|B1|Baseline|15 Mcg BID / 30 Mcg QD|Arformoterol 15 mcg twice a day (morning and evening) for one visit followed by Arformoterol 30 mcg once a day (morning) and placebo (evening) for the next visit.
1096390|NCT00571428|P2|Participant Flow|30 Mcg QD / 15 Mcg BID|Arformoterol 30 mcg once a day (morning) and placebo (evening) for one visit followed by Arformoterol 15 mcg twice a day (morning and evening) for the next visit.
1096391|NCT00571428|P1|Participant Flow|15 Mcg BID / 30 Mcg QD|Arformoterol 15 mcg twice a day (morning and evening) for one visit followed by Arformoterol 30 mcg once a day (morning) and placebo (evening) for the next visit.
1096392|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
1096393|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
1096394|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
1096395|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
1096396|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
1096397|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
1096398|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
1096399|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
1096400|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
1096401|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
1096402|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
1096403|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
1096404|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
1096405|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
1096406|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
1096407|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
1096408|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
1096409|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
1096410|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
1096411|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
1096412|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
1096413|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
1096414|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
1096415|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
1096416|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
1096417|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
1096418|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
1096419|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
1096420|NCT00571428|E2|Reported Event|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
1096421|NCT00571428|E1|Reported Event|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
1096422|NCT00571324|B1|Baseline|Subject Population|All subjects enrolled and treated in the protocol served as their own control. Because of this and the small sample size, baseline characteristic data is presented together.
1096423|NCT00571324|P2|Participant Flow|Vehicle First, Then Exendin-(9-39)|Normal saline vehicle infusion was administered intravenously (IV) after an overnight fast. The infusion was given over 6 hours. The following day, after another overnight fast, Exendin-(9-39) was infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion. During both infusions, blood glucose levels were measured every 20 minutes.
1096424|NCT00571324|P1|Participant Flow|Exendin-(9-39) First, the Vehicle|Exendin-(9-39) was administered intravenously (IV) after an overnight fast. Exendin-(9-39) was infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion. The following day, after another overnight fast, normal saline (control) vehicle infusion was administered intravenously (IV) over 6 hours. During both infusions, blood glucose levels were measured every 20 minutes.
1096425|NCT00571324|O2|Outcome|Vehicle|Normal saline vehicle infusion was administered intravenously (IV) after an overnight fast. The infusion was given over 6 hours.
1096426|NCT00571324|O1|Outcome|Exendin-(9-39)|Exendin-(9-39) was administered intravenously (IV) after an overnight fast. Exendin-(9-39) was infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion.
1096427|NCT00571324|O2|Outcome|Vehicle|Normal saline vehicle infusion was administered intravenously (IV) after an overnight fast. The infusion was given over 6 hours.
1096428|NCT00571324|O1|Outcome|Exendin-(9-39)|Exendin-(9-39) was administered intravenously (IV) after an overnight fast. Exendin-(9-39) was infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion.
1096429|NCT00571324|O2|Outcome|Vehicle|Normal saline vehicle infusion was administered intravenously (IV) after an overnight fast. The infusion was given over 6 hours.
1096430|NCT00571324|O1|Outcome|Exendin-(9-39)|Exendin-(9-39) was administered intravenously (IV) after an overnight fast. Exendin-(9-39) was infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion.
1096431|NCT00571324|O2|Outcome|Vehicle|Normal saline vehicle infusion was administered intravenously (IV) after an overnight fast. The infusion was given over 6 hours.
1096522|NCT00570778|O3|Outcome|Indacaterol 600 μg|Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
1096432|NCT00571324|O1|Outcome|Exendin-(9-39)|Exendin-(9-39) was administered intravenously (IV) after an overnight fast. Exendin-(9-39) was infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion.
1096433|NCT00571324|E2|Reported Event|Vehicle|Normal saline vehicle infusion was administered intravenously (IV) after an overnight fast. The infusion was given over 6 hours.
1096434|NCT00571324|E1|Reported Event|Exendin-(9-39)|Exendin-(9-39) was administered intravenously (IV) after an overnight fast. Exendin-(9-39) was infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion.
1096435|NCT00571194|B1|Baseline|A Single-Dose Pilot Study|Study drug given and have levels done to measure pharmacokinetics
1096436|NCT00571194|P1|Participant Flow|Pravastatin|Study drug given and have levels done to measure pharmacokinetics.
1096437|NCT00571194|O1|Outcome|A Single-Dose Pilot Study|Study drug given and have levels done to measure pharmacokinetics
1096438|NCT00571194|E1|Reported Event|A Single-Dose Pilot Study|Study drug given and have levels done to measure pharmacokinetics
1096439|NCT00571103|B1|Baseline|Open Label|All subjects received the drug.
1096440|NCT00571103|P1|Participant Flow|Open Label|All subjects received the drug.
1096441|NCT00571103|O1|Outcome|Open Label|All subjects received the drug.
1096442|NCT00571103|O1|Outcome|Open Label|All subjects received the drug.
1096443|NCT00571103|E1|Reported Event|Open Label|All subjects received the drug.
1096444|NCT00571038|B3|Baseline|Total|Total of all reporting groups
1096445|NCT00571038|B2|Baseline|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
1096446|NCT00571038|B1|Baseline|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
1096447|NCT00571038|P2|Participant Flow|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
1096448|NCT00571038|P1|Participant Flow|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
1096449|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
1096450|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
1096556|NCT00570739|B1|Baseline|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevalm placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. This treatment duration was 16 weeks.
1096451|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
1096452|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
1096453|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
1096454|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
1096455|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
1096456|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
1096457|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
1096458|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
1096576|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096459|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
1096460|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
1096461|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
1096462|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
1096463|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
1096464|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
1096465|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
1096466|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
1096467|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
1096468|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
1096469|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
1096470|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
1096557|NCT00570739|P4|Participant Flow|Pre-diabetic Group: Colesevelam|This group was given 6 colesevelam tablets, 625mg, once a day. This treatment duration was 16 weeks.
1099677|NCT00561678|O2|Outcome|Placebo|Placebo - normal saline 0.5/ug/kg/hr
1096471|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
1096472|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
1096473|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
1096474|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
1096475|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
1096476|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
1096477|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
1096478|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
1096479|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
1096480|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
1096481|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
1096482|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
1096483|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
1096484|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
1096485|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
1096486|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
1096487|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
1096488|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
1096489|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
1096490|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
1096558|NCT00570739|P3|Participant Flow|Pre-diabetic Group: Placebo|This group was given 6 placebo tablets once a day. They matched the colesevelam tablets. This treatment duration was 16 weeks.
1099760|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
1096491|NCT00571038|E2|Reported Event|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
1096492|NCT00571038|E1|Reported Event|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
1096493|NCT00570960|B3|Baseline|Total|Total of all reporting groups
1096494|NCT00570960|B2|Baseline|Standard of Care Albumin Arm|"antibiotic therapy in addition to human albumin, 1.5 g/kg on day one and 1.0 g/kg on day three~human albumin : human albumin 1.5 g/kg on day one and 1.0 g/kg on day three"
1096495|NCT00570960|B1|Baseline|Dextran Therapy Arm|"antibiotic therapy in addition to dextran 70, 1.0 g/kg on days one, two and three~Dextran 70 : dextran 70, 1.0 g/kg on days one, two and three"
1096496|NCT00570960|P2|Participant Flow|Standard of Care Albumin Arm|"antibiotic therapy in addition to human albumin, 1.5 g/kg on day one and 1.0 g/kg on day three~human albumin : human albumin 1.5 g/kg on day one and 1.0 g/kg on day three"
1096497|NCT00570960|P1|Participant Flow|Dextran Therapy Arm|"antibiotic therapy in addition to dextran 70, 1.0 g/kg on days one, two and three~Dextran 70 : dextran 70, 1.0 g/kg on days one, two and three"
1096498|NCT00570960|O2|Outcome|Standard of Care Albumin Arm|"antibiotic therapy in addition to human albumin, 1.5 g/kg on day one and 1.0 g/kg on day three~human albumin : human albumin 1.5 g/kg on day one and 1.0 g/kg on day three"
1096499|NCT00570960|O1|Outcome|Dextran Therapy Arm|"antibiotic therapy in addition to dextran 70, 1.0 g/kg on days one, two and three~Dextran 70 : dextran 70, 1.0 g/kg on days one, two and three"
1096500|NCT00570960|E2|Reported Event|Standard of Care Albumin Arm|"antibiotic therapy in addition to human albumin, 1.5 g/kg on day one and 1.0 g/kg on day three~human albumin : human albumin 1.5 g/kg on day one and 1.0 g/kg on day three"
1096501|NCT00570960|E1|Reported Event|Dextran Therapy Arm|"antibiotic therapy in addition to dextran 70, 1.0 g/kg on days one, two and three~Dextran 70 : dextran 70, 1.0 g/kg on days one, two and three"
1096520|NCT00570778|O1|Outcome|Indacaterol/Glycopyrrolate 300/50 μg|One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
1096502|NCT00570921|B1|Baseline|Fulvestrant & Everolimus|"Fulvestrant + Everolimus~Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses—one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that.~Everolimus: Everolimus tablets, two-5 mg tablets a day~Fulvestrant: intramuscular, 500 mg in two divided doses- one on each side- on day 1, then 250mg on day 14, then 250 mg on day 28 and every 4 weeks +/- 3 days thereafter"
1096503|NCT00570921|P1|Participant Flow|Fulvestrant + Everolimus|"Fulvestrant + Everolimus~Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses—one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that."
1096504|NCT00570921|O1|Outcome|Fulvestrant + Everolimus|"Fulvestrant + Everolimus~Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses—one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that."
1096505|NCT00570921|O1|Outcome|Fulvestrant + Everolimus|"Fulvestrant + Everolimus~Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses—one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that."
1096506|NCT00570921|O1|Outcome|Fulvestrant + Everolimus|"Fulvestrant + Everolimus~Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses—one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that."
1096507|NCT00570921|E1|Reported Event|Fulvestrant + Everolimus|"Fulvestrant + Everolimus~Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses—one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that."
1096508|NCT00570908|B1|Baseline|WBRT + Capecitabine + Sunitinib|capecitabine concurrently with WBRT(Whole Brain Radiotherapy 30 Gy in 10 fractions) followed by combination capecitabine with sunitinib(Sutent)
1096509|NCT00570908|P1|Participant Flow|WBRT + Capecitabine + Sunitinib|capecitabine concurrently with WBRT(Whole Brain Radiotherapy 30 Gy in 10 fractions) followed by combination capecitabine with sunitinib(Sutent)
1096510|NCT00570908|O1|Outcome|WBRT + Capecitabine + Sunitinib|capecitabine concurrently with WBRT(Whole Brain Radiotherapy 30 Gy in 10 fractions) followed by combination capecitabine with sunitinib(Sutent)
1096511|NCT00570908|E1|Reported Event|WBRT + Capecitabine + Sunitinib|capecitabine concurrently with WBRT(Whole Brain Radiotherapy 30 Gy in 10 fractions) followed by combination capecitabine with sunitinib(Sutent)
1096512|NCT00570778|B1|Baseline|Overall Population|Participants were randomized and received the following 4 treatments: 1-Two placebo capsules inhaled once daily via a SDDPI for 7 days, 2-One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days, 3-One Indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days and 4-Two Indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days. There was a 7 day washout period between the four treatment periods.
1096601|NCT00570739|O4|Outcome|Pre-Diabetes Group: Colesevelam (LOCF)|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096513|NCT00570778|P4|Participant Flow|D: Placebo- Ind/Glyc 300/50 μg- Ind 300 μg- Ind 600 μg|"Treatment Period 1: Two placebo capsules inhaled once daily via a SDDPI for 7 days.~Treatment Period 2: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days.~Treatment Period 3: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days.~Treatment Period 4: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days."
1096514|NCT00570778|P3|Participant Flow|C: Ind/Glyc 300/50 μg- Ind 300 μg- Ind 600 μg- Placebo|"Treatment Period 1: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days.~Treatment Period 2: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days.~Treatment Period 3: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days.~Treatment Period 4: Two placebo capsules inhaled once daily via a SDDPI for 7 days."
1096515|NCT00570778|P2|Participant Flow|B: Ind 600 μg- Placebo- Ind/Glyc 300/50 μg- Ind 300 μg|"Treatment Period 1: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days.~Treatment Period 2: Two placebo capsules inhaled once daily via a SDDPI for 7 days.~Treatment Period 3: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days.~Treatment Period 4: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days."
1096516|NCT00570778|P1|Participant Flow|A: Ind 300 μg- Ind 600 μg- Placebo- Ind/Glyc 300/50 μg|"Treatment Period 1: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a single dose dry powder inhaler (SDDPI) for 7 days.~Treatment Period 2: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days.~Treatment Period 3: Two placebo capsules inhaled once daily via a SDDPI for 7 days.~Treatment Period 4: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days."
1096517|NCT00570778|O4|Outcome|Placebo|Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
1096518|NCT00570778|O3|Outcome|Indacaterol 600 μg|Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
1096519|NCT00570778|O2|Outcome|Indacaterol 300 μg|One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
1096523|NCT00570778|O2|Outcome|Indacaterol 300 μg|One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
1096524|NCT00570778|O1|Outcome|Indacaterol/Glycopyrrolate 300/50 μg|One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
1096525|NCT00570778|O4|Outcome|Placebo|Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
1096526|NCT00570778|O3|Outcome|Indacaterol 600 μg|Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
1096527|NCT00570778|O2|Outcome|Indacaterol 300 μg|One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
1096528|NCT00570778|O1|Outcome|Indacaterol/Glycopyrrolate 300/50 μg|One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
1096529|NCT00570778|E4|Reported Event|Placebo|Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
1096530|NCT00570778|E3|Reported Event|Indacaterol 600 μg|Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
1096531|NCT00570778|E2|Reported Event|Indacaterol 300 μg|One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
1096532|NCT00570778|E1|Reported Event|Indacaterol/Glycopyrrolate 300/50 μg|One indacaterol/glycopyrrolate 300 μg /50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
1096533|NCT00570765|B4|Baseline|Total|Total of all reporting groups
1096534|NCT00570765|B3|Baseline|Placebo|Placebo by mouth, daily
1096535|NCT00570765|B2|Baseline|50 mg|INT-747 50 mg by mouth, daily
1096536|NCT00570765|B1|Baseline|10 mg|INT-747 10 mg by mouth, daily
1096537|NCT00570765|P3|Participant Flow|Placebo|Placebo by mouth, daily
1096538|NCT00570765|P2|Participant Flow|50 mg|INT-747 50 mg by mouth, daily
1096539|NCT00570765|P1|Participant Flow|10 mg|INT-747 10 mg by mouth, daily
1096540|NCT00570765|O3|Outcome|Placebo|Placebo by mouth, daily
1096541|NCT00570765|O2|Outcome|50 mg|INT-747 50 mg by mouth, daily
1096542|NCT00570765|O1|Outcome|10 mg|INT-747 10 mg by mouth, daily
1096543|NCT00570765|O3|Outcome|Placebo|Placebo by mouth, daily
1096544|NCT00570765|O2|Outcome|50 mg|INT-747 50 mg by mouth, daily
1096545|NCT00570765|O1|Outcome|10 mg|INT-747 10 mg by mouth, daily
1096546|NCT00570765|O3|Outcome|Placebo|Placebo by mouth, daily
1096547|NCT00570765|O2|Outcome|50 mg|INT-747 50 mg by mouth, daily
1096548|NCT00570765|O1|Outcome|10 mg|INT-747 10 mg by mouth, daily
1096549|NCT00570765|E3|Reported Event|Placebo|Placebo by mouth, daily
1096550|NCT00570765|E2|Reported Event|50 mg|INT-747 50 mg by mouth, daily
1096551|NCT00570765|E1|Reported Event|10 mg|INT-747 10 mg by mouth, daily
1096552|NCT00570739|B5|Baseline|Total|Total of all reporting groups
1096553|NCT00570739|B4|Baseline|Pre-diabetic Group: Colesevelam|This group received 6 colesevelam tablets, 625mg, once per day for 16 weeks.
1096554|NCT00570739|B3|Baseline|Pre-diabetic Group: Placebo|This group received 6 colesevelam matching placebo tablets once per day for 16 weeks
1096555|NCT00570739|B2|Baseline|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colevevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. This treatment duration was 16 weeks.
1097101|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
1096559|NCT00570739|P2|Participant Flow|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colevevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. This treatment duration was 16 weeks.
1096560|NCT00570739|P1|Participant Flow|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevalm placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. This treatment duration was 16 weeks.
1096561|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096562|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096563|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096564|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096565|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096566|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096567|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096568|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096569|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096570|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096571|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096572|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096573|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096574|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096575|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096577|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096578|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096579|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096580|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096581|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096582|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096583|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096584|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096585|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096586|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096587|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096588|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096589|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096590|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096591|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096592|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096593|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096594|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096595|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096596|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096597|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096598|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096599|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096600|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1097102|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
1096603|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096604|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096605|NCT00570739|O4|Outcome|Pre-Diabetes Group: Colesevelam (LOCF)|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096606|NCT00570739|O3|Outcome|Pre-Diabetes Group: Placebo (LOCF)|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096607|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096608|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096609|NCT00570739|O4|Outcome|Pre-Diabetes Group: Colesevelam (LOCF)|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096610|NCT00570739|O3|Outcome|Pre-Diabetes Group: Placebo (LOCF)|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096611|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096612|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096613|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096614|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096615|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096616|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096617|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096618|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096619|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096620|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096621|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1102455|NCT00556543|O1|Outcome|All Study Subjects|
1096622|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096623|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096624|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096625|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096626|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096627|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096628|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096629|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg once daily. The total treatment duration was 16 weeks.
1096630|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The total treatment duration was 16 weeks.
1096631|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
1096632|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
1096633|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
1096634|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
1096635|NCT00570739|O4|Outcome|Type 2 Diabetes Group:Colesevelam+Metformin(LOCF)|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
1096636|NCT00570739|O3|Outcome|Type 2 Diabetes Group: Placebo + Metformin (LOCF)|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
1096637|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
1096638|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
1096639|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
1097103|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
1096640|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
1096641|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
1096642|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
1096643|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
1096644|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
1096645|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
1096646|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
1096647|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
1096648|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
1096649|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
1096650|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
1096651|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
1102456|NCT00556543|O1|Outcome|All Study Subjects|
1096652|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
1096653|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
1096654|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
1096655|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
1096656|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
1096657|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
1096658|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
1096659|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
1096660|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
1096661|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
1096662|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
1096663|NCT00570739|O4|Outcome|Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF)|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
1096664|NCT00570739|O3|Outcome|Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF)|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
1096665|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin for 16 Weeks|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
1096666|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
1096667|NCT00570739|O4|Outcome|Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF)|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
1096668|NCT00570739|O3|Outcome|Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF)|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
1096669|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin for 16 Weeks|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
1096670|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
1096671|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
1096672|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
1096673|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
1096674|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
1096675|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
1096676|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
1096750|NCT00570687|O3|Outcome|Amendment 1 - Insulin Lispro 10 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
1096677|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
1096678|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
1096679|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
1096680|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
1096681|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
1096682|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
1096683|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
1096684|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
1096685|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam+Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
1096686|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
1096687|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
1096688|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
1096689|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
1096690|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
1096691|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
1096692|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
1096693|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
1096694|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
1096695|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
1096696|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
1096697|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
1096698|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
1096699|NCT00570739|O2|Outcome|Type 2 Diabetes Group:Colesevelam+Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
1096700|NCT00570739|O1|Outcome|Type 2 Diabetes Group:Placebo+Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
1096701|NCT00570739|O2|Outcome|Type 2 Diabetes Group:Colesevelam+Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
1096702|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo+Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
1096703|NCT00570739|O2|Outcome|Type 2 Diabetes Group:Colesevelam+Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
1096704|NCT00570739|O1|Outcome|Type 2 Diabetes Group:Placebo+Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
1096705|NCT00570739|E4|Reported Event|Pre-diabetic Group: Colesevelam|This group was given 6 colesevelam tablets, 625mg, once a day. This treatment duration was 16 weeks.
1096706|NCT00570739|E3|Reported Event|Pre-diabetic Group: Placebo|This group was given 6 placebo tablets once a day. They matched the colesevelam tablets. This treatment duration was 16 weeks.
1096707|NCT00570739|E2|Reported Event|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colevevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. This treatment duration was 16 weeks.
1096708|NCT00570739|E1|Reported Event|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevalm placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. This treatment duration was 16 weeks.
1096709|NCT00570713|B3|Baseline|Total|Total of all reporting groups
1096710|NCT00570713|B2|Baseline|Placebo Plus Gemcitabine (‘Placebo’)|Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
1096711|NCT00570713|B1|Baseline|MORAb-009 Plus Gemcitabine (‘MORAb-009’)|MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
1096712|NCT00570713|P2|Participant Flow|Placebo Plus Gemcitabine (‘Placebo’)|Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
1096713|NCT00570713|P1|Participant Flow|MORAb-009 Plus Gemcitabine (‘MORAb-009’)|MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
1096714|NCT00570713|O2|Outcome|Placebo Plus Gemcitabine ('Placebo')|Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
1096737|NCT00570687|O4|Outcome|Original Protocol - TI Inhalation Powder 45 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
1097104|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
1096715|NCT00570713|O1|Outcome|MORAb-009 Plus Gemcitabine ('MORAb-009')|MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
1096716|NCT00570713|O2|Outcome|Placebo Plus Gemcitabine ('Placebo')|Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
1096717|NCT00570713|O1|Outcome|MORAb-009 Plus Gemcitabine ('MORAb-009')|MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
1096718|NCT00570713|O2|Outcome|Placebo Plus Gemcitabine ('Placebo')|Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
1096719|NCT00570713|O1|Outcome|MORAb-009 Plus Gemcitabine ('MORAb-009')|MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
1096751|NCT00570687|O2|Outcome|Amendment 1 - TI Inhalation Powder 60U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
1096720|NCT00570713|E2|Reported Event|Placebo Plus Gemcitabine (‘Placebo’)|Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
1096721|NCT00570713|E1|Reported Event|MORAb-009 Plus Gemcitabine (‘MORAb-009’)|MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
1096722|NCT00570687|B3|Baseline|Total|Total of all reporting groups
1096723|NCT00570687|B2|Baseline|Original Protocol|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
1096724|NCT00570687|B1|Baseline|Amendment 1|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
1096725|NCT00570687|P10|Participant Flow|Original Protocol: Insulin Lispro to Exubera to TI|12 U of subcutaneously administered insulin lispro, followed by 4 mg of Exubera administered via inhalation, and then 45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler
1096726|NCT00570687|P9|Participant Flow|Original Protocol: Insulin Lispro to TI to Exubera|12 U of subcutaneously administered insulin lispro, followed by 45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, and then 4 mg of Exubera administered via inhalation
1096727|NCT00570687|P8|Participant Flow|Original Protocol: Exubera to TI to Insulin Lispro|4 mg of Exubera administered via inhalation, followed by 45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler,. and then 12 U of subcutaneously administered insulin lispro
1096728|NCT00570687|P7|Participant Flow|Original Protocol: Exubera to Insulin Lispro to TI|4 mg of Exubera administered via inhalation, followed by 12 U of subcutaneously administered insulin lispro,and then 45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler
1096729|NCT00570687|P6|Participant Flow|Original Protocol: TI to Exubera to Insulin Lispro|45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, followed by 4 mg of Exubera administered via inhalation, and then 12 U of subcutaneously administered insulin lispro
1096730|NCT00570687|P5|Participant Flow|Original Protocol: TI to Insulin Lispro to Exubera|45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, followed by 12 U of subcutaneously administered insulin lispro, and then 4 mg of Exubera administered via inhalation
1096731|NCT00570687|P4|Participant Flow|Amendment 1: 10 U Insulin Lispro Then 90 U TI|10 U subcutaneously administered insulin lispro, followed by 90 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler
1096732|NCT00570687|P3|Participant Flow|Amendment 1: TI 90 U Then 10 U Insulin Lispro|90 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, followed by 10 U subcutaneously administered insulin lispro
1096733|NCT00570687|P2|Participant Flow|Amendment 1: 10 U Insulin Lispro Then 60 U TI|10 U subcutaneously administered insulin lispro, followed by 60 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler
1096734|NCT00570687|P1|Participant Flow|Amendment 1: TI 60 U Then Insulin Lispro 10 U|60 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, followed by 10 U subcutaneously administered insulin lispro
1096735|NCT00570687|O6|Outcome|Original Protocol - Insulin Lispro 12 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
1096736|NCT00570687|O5|Outcome|Original Protocol - Exubera 4 mg|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
1097105|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
1096738|NCT00570687|O3|Outcome|Amendment 1 - Insulin Lispro 10 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
1096739|NCT00570687|O2|Outcome|Amendment 1 - TI Inhalation Powder 60U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
1096740|NCT00570687|O1|Outcome|Amendment 1 - TI Inhalation Powder 90 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
1096741|NCT00570687|O6|Outcome|Original Protocol - Insulin Lispro 12 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
1096742|NCT00570687|O5|Outcome|Original Protocol - Exubera 4 mg|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
1096743|NCT00570687|O4|Outcome|Original Protocol - TI Inhalation Powder 45 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
1096744|NCT00570687|O3|Outcome|Amendment 1 - Insulin Lispro 10 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
1096745|NCT00570687|O2|Outcome|Amendment 1 - TI Inhalation Powder 60U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
1096746|NCT00570687|O1|Outcome|Amendment 1 - TI Inhalation Powder 90 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
1096747|NCT00570687|O6|Outcome|Original Protocol - Insulin Lispro 12 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
1096748|NCT00570687|O5|Outcome|Original Protocol - Exubera 4 mg|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
1096749|NCT00570687|O4|Outcome|Original Protocol - TI Inhalation Powder 45 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
1097606|NCT00567840|O1|Outcome|PA-824 200 mg|PA-824: 200 mg per day for 14 consecutive days
1096752|NCT00570687|O1|Outcome|Amendment 1 - TI Inhalation Powder 90 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
1096753|NCT00570687|E6|Reported Event|Original Protocol - Insulin Lispro 12 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
1096754|NCT00570687|E5|Reported Event|Original Protocol - Exubera 4 mg|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
1096755|NCT00570687|E4|Reported Event|Original Protocol - TI Inhalation Powder 45 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
1096756|NCT00570687|E3|Reported Event|Amendment 1 - Insulin Lispro 10 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
1096757|NCT00570687|E2|Reported Event|Amendment 1 - TI Inhalation Powder 60 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
1096758|NCT00570687|E1|Reported Event|Amendment 1 -TI Inhalation Powder 90 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
1096759|NCT00570674|B1|Baseline|All Phase I Participants|Participants received Abraxane according to the established dose escalation schedule 50mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. For Dose Level 1 participants, one dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
1096760|NCT00570674|P7|Participant Flow|All Phase II Participants|Participants received Abraxane according to the established recommended Phase II dose of Abraxane (50mg/m2 IV) then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
1096761|NCT00570674|P6|Participant Flow|Phase I Dose Level 4 Expansion Cohort: AC-RT|"Phase I Dose Level 4 participants received Abraxane 50mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.~If no DLTs are observed at dose level 4 then ten additional participants (expansion cohort) will be enrolled at that dose level."
1096762|NCT00570674|P5|Participant Flow|Phase I Dose Level 4: AC-RT|Phase I Dose Level 4 participants received Abraxane 50mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
1096763|NCT00570674|P4|Participant Flow|Phase I Dose Level 3: AC-RT|Phase I Dose Level 3 participants received Abraxane 40mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
1096764|NCT00570674|P3|Participant Flow|Phase I Dose Level 2: AC-RT|Phase I Dose Level 2 participants received Abraxane 30mg/m2 IV then carboplatin AUC 1.5 weekly IV during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
1096878|NCT00570310|E1|Reported Event|Pregabalin|Patients were treated with pregabalin (up to 600 mg/day by mouth (po)) for the entire double-blind period.
1096765|NCT00570674|P2|Participant Flow|Phase I Dose Level -1: AC-RT|Phase I Dose Level -1 participants received Abraxane 20mg/m2 IV then carboplatin AUC 1.5 weekly IV during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
1096766|NCT00570674|P1|Participant Flow|Phase I Dose Level 1: ACE-RT|Phase I Dose Level 1 participants received Abraxane 20mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. One dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
1096767|NCT00570674|O1|Outcome|All Phase I Participants|Participants received Abraxane according to the established dose escalation schedule then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. For Dose Level 1 participants, one dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
1096768|NCT00570674|O1|Outcome|All Phase I Participants|Participants received Abraxane according to the established dose escalation schedule then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. For Dose Level 1 participants, one dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
1096769|NCT00570674|O1|Outcome|All Phase II Participants|Participants received Abraxane according to the established recommended Phase II dose of Abraxane (50mg/m2 IV) then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
1096770|NCT00570674|O5|Outcome|Phase I Dose Level 4: AC-RT|Phase I Dose Level 4 participants received Abraxane 50mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
1096852|NCT00570349|B1|Baseline|Inhaled Nitric Oxide Low Dose|Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours
1096771|NCT00570674|O4|Outcome|Phase I Dose Level 3: AC-RT|Phase I Dose Level 3 participants received Abraxane 40mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
1096772|NCT00570674|O3|Outcome|Phase I Dose Level 2: AC-RT|Phase I Dose Level 2 participants received Abraxane 30mg/m2 IV then carboplatin AUC 1.5 weekly IV during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
1096773|NCT00570674|O2|Outcome|Phase I Dose Level -1: AC-RT|Phase I Dose Level -1 participants received Abraxane 20mg/m2 IV then carboplatin AUC 1.5 weekly IV during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
1096774|NCT00570674|O1|Outcome|Phase I Dose Level 1: ACE-RT|Phase I Dose Level 1 participants received Abraxane 20mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. One dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
1096775|NCT00570674|O1|Outcome|All Phase I Participants|Participants received Abraxane according to the established dose escalation schedule then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. For Dose Level 1 participants, one dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
1096776|NCT00570674|E1|Reported Event|All Phase I Participants|Participants received Abraxane according to the established dose escalation schedule then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. For Dose Level 1 participants, one dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
1096777|NCT00570531|B1|Baseline|Bevacizumab|"Bevacizumab: Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.~Paclitaxel: Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m^2 will be administered as a 1-hour intravenous infusion on days 2, 9, 16, 23, and 30. It will be given before cisplatin administration.~Cisplatin: Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m^2 over 1 hour on days 2, 9, 16, 23, and 30. It will be given after paclitaxel.~5-Fluorouracil: Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.~Radiation Therapy: Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays."
1096796|NCT00570492|B1|Baseline|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
1096797|NCT00570492|P3|Participant Flow|FFNS 110 mcg: Double-blind Treatment Period|Participants were randomized to receive fluticasone furoate nasal spray (FFNS) 110 micrograms (mcg) OD as 2 sprays per nostril during the 52-week Double-blind Treatment Period
1096798|NCT00570492|P2|Participant Flow|Placebo: Double-blind Treatment Period|Participants were randomized to receive matching placebo nasal spray OD as 2 sprays per nostril during the 52-week Double-blind Treatment Period
1096778|NCT00570531|P1|Participant Flow|Bevacizumab|"Bevacizumab: Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.~Paclitaxel: Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m^2 will be administered as a 1-hour intravenous infusion on days 2, 9, 16, 23, and 30. It will be given before cisplatin administration.~Cisplatin: Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m^2 over 1 hour on days 2, 9, 16, 23, and 30. It will be given after paclitaxel.~5-Fluorouracil: Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.~Radiation Therapy: Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays."
1096779|NCT00570531|O1|Outcome|Bevacizumab|"Bevacizumab: Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.~Paclitaxel: Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m^2 will be administered as a 1-hour intravenous infusion on days 2, 9, 16, 23, and 30. It will be given before cisplatin administration.~Cisplatin: Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m^2 over 1 hour on days 2, 9, 16, 23, and 30. It will be given after paclitaxel.~5-Fluorouracil: Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.~Radiation Therapy: Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays."
1096805|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
1096806|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
1096853|NCT00570349|P3|Participant Flow|Nitrogen|Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
1097607|NCT00567840|O5|Outcome|Rifafour|Rifafour e-275 on Days 1 to 14, dosed by weight
1096780|NCT00570531|O1|Outcome|Bevacizumab|"Bevacizumab: Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.~Paclitaxel: Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m^2 will be administered as a 1-hour intravenous infusion on days 2, 9, 16, 23, and 30. It will be given before cisplatin administration.~Cisplatin: Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m^2 over 1 hour on days 2, 9, 16, 23, and 30. It will be given after paclitaxel.~5-Fluorouracil: Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.~Radiation Therapy: Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays."
1096781|NCT00570531|O1|Outcome|Bevacizumab|"Bevacizumab: Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.~Paclitaxel: Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m^2 will be administered as a 1-hour intravenous infusion on days 2, 9, 16, 23, and 30. It will be given before cisplatin administration.~Cisplatin: Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m^2 over 1 hour on days 2, 9, 16, 23, and 30. It will be given after paclitaxel.~5-Fluorouracil: Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.~Radiation Therapy: Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays."
1096782|NCT00570531|E1|Reported Event|Bevacizumab|"Bevacizumab: Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.~Paclitaxel: Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m^2 will be administered as a 1-hour intravenous infusion on days 2, 9, 16, 23, and 30. It will be given before cisplatin administration.~Cisplatin: Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m^2 over 1 hour on days 2, 9, 16, 23, and 30. It will be given after paclitaxel.~5-Fluorouracil: Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.~Radiation Therapy: Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays."
1096783|NCT00570505|B1|Baseline|LapBand|Subjects implanted with the LapBand(R) Adjustable Gastric Band System
1096784|NCT00570505|P1|Participant Flow|LapBand|"All subjects who receive the LAP-BAND System.~LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
1096785|NCT00570505|O1|Outcome|LapBand|"All subjects who receive the LAP-BAND System.~LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
1096786|NCT00570505|O1|Outcome|LapBand|"All subjects who receive the LAP-BAND System.~LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
1096787|NCT00570505|O1|Outcome|LapBand|"All subjects who receive the LAP-BAND System.~LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
1096788|NCT00570505|O1|Outcome|LapBand|"All subjects who receive the LAP-BAND System.~LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
1096789|NCT00570505|O1|Outcome|LapBand|"All subjects who receive the LAP-BAND System.~LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
1096790|NCT00570505|O1|Outcome|LapBand|"All subjects who receive the LAP-BAND System.~LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
1096791|NCT00570505|O1|Outcome|LapBand|"All subjects who receive the LAP-BAND System.~LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
1096792|NCT00570505|O1|Outcome|LapBand|"All subjects who receive the LAP-BAND System.~LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
1096793|NCT00570505|E1|Reported Event|LapBand|Subjects implanted with the LapBand(R) Adjustable Gastric Band System
1096794|NCT00570492|B3|Baseline|Total|Total of all reporting groups
1096795|NCT00570492|B2|Baseline|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
1096799|NCT00570492|P1|Participant Flow|Placebo: Baseline Period|Placebo nasal spray administered once daily (OD) as 2 sprays per nostril to all enrolled participants during the 16-week Single-blind Baseline period, to assess the baseline growth velocity
1096800|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
1096801|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
1096802|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
1096803|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
1096804|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
1096851|NCT00570349|B2|Baseline|Inhaled Nitric Oxide High Dose|High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours.
1096807|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
1096808|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
1096809|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
1096810|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
1096811|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
1096812|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
1096813|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
1096814|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
1096815|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
1096816|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
1096817|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
1096818|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
1096819|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
1096820|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
1096879|NCT00570232|B1|Baseline|Tarceva|"All patients will be prescribed Tarceva 150mg daily~Erlotinib: 150 mg per day by mouth for 12 months"
1097106|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
1096821|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
1096822|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
1096823|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
1096824|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
1096825|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
1096826|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
1096827|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
1102457|NCT00556543|O1|Outcome|All Study Subjects|
1096828|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
1096829|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
1096830|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
1096831|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
1096832|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
1096833|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
1096834|NCT00570492|E2|Reported Event|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
1096835|NCT00570492|E1|Reported Event|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
1096836|NCT00570401|B1|Baseline|Dasatinib|Dasatinib in Patients with Lung Adenocarcinoma Receiving Erlotinib with Acquired Resistance to EGFR Tyrosine Kinase Inhibitors (TKIs)
1096837|NCT00570401|P1|Participant Flow|Dasatinib|Dasatinib in Patients with Lung Adenocarcinoma Receiving Erlotinib with Acquired Resistance to EGFR Tyrosine Kinase Inhibitors (TKIs)
1096838|NCT00570401|O1|Outcome|Dasatinib|Dasatinib in Patients with Lung Adenocarcinoma Receiving Erlotinib with Acquired Resistance to EGFR Tyrosine Kinase Inhibitors (TKIs)
1096839|NCT00570401|E1|Reported Event|Dasatinib|Dasatinib in Patients with Lung Adenocarcinoma Receiving Erlotinib with Acquired Resistance to EGFR Tyrosine Kinase Inhibitors (TKIs)
1096840|NCT00570362|B3|Baseline|Total|Total of all reporting groups
1096841|NCT00570362|B2|Baseline|Control Group|The control group was recruited from other age-gender-matched volunteers, and it was composed of subjects who had never neither glaucoma nor other ocular diseases such as cataract, diabetic ratinopathy, or age related macular degeneration.
1096842|NCT00570362|B1|Baseline|Normal Tension Glaucoma Group|Patients were diagnosed as having normal tension glaucoma if IOP measurements were lesser than 22 mm Hg by Goldmann applanation tonometry, characteristic glaucomatous cupping of the optic disc on fundoscopic examination, normal open anterior chamber angles by gonioscopy, and repeatable visual field defects consistent with the diagnosis of glaucoma, according to results obtained with program 24-2 of the Humphrey Field Analyzer (Carl Zeiss Meditec, Dublin, CA).
1096843|NCT00570362|P2|Participant Flow|Control Group|The control group was recruited from other age-gender-matched volunteers, and it was composed of subjects who had never neither glaucoma nor other ocular diseases such as cataract, diabetic ratinopathy, or age related macular degeneration.
1096876|NCT00570310|O1|Outcome|Pregabalin|Patients who were randomized to pregabalin and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.
1096844|NCT00570362|P1|Participant Flow|Normal Tension Glaucoma Group|Patients were diagnosed as having normal tension glaucoma if IOP measurements were lesser than 22 mm Hg by Goldmann applanation tonometry, characteristic glaucomatous cupping of the optic disc on fundoscopic examination, normal open anterior chamber angles by gonioscopy, and repeatable visual field defects consistent with the diagnosis of glaucoma, according to results obtained with program 24-2 of the Humphrey Field Analyzer (Carl Zeiss Meditec, Dublin, CA).
1096845|NCT00570362|O2|Outcome|Control Group|The control group was recruited from other age-gender-matched volunteers, and it was composed of subjects who had never neither glaucoma nor other ocular diseases such as cataract, diabetic ratinopathy, or age related macular degeneration.
1096846|NCT00570362|O1|Outcome|Normal Tension Glaucoma Group|Patients were diagnosed as having normal tension glaucoma if IOP measurements were lesser than 22 mm Hg by Goldmann applanation tonometry, characteristic glaucomatous cupping of the optic disc on fundoscopic examination, normal open anterior chamber angles by gonioscopy, and repeatable visual field defects consistent with the diagnosis of glaucoma, according to results obtained with program 24-2 of the Humphrey Field Analyzer (Carl Zeiss Meditec, Dublin, CA).
1096847|NCT00570362|E2|Reported Event|Control Group|The control group was recruited from other age-gender-matched volunteers, and it was composed of subjects who had never neither glaucoma nor other ocular diseases such as cataract, diabetic ratinopathy, or age related macular degeneration.
1096848|NCT00570362|E1|Reported Event|Normal Tension Glaucoma Group|Patients were diagnosed as having normal tension glaucoma if IOP measurements were lesser than 22 mm Hg by Goldmann applanation tonometry, characteristic glaucomatous cupping of the optic disc on fundoscopic examination, normal open anterior chamber angles by gonioscopy, and repeatable visual field defects consistent with the diagnosis of glaucoma, according to results obtained with program 24-2 of the Humphrey Field Analyzer (Carl Zeiss Meditec, Dublin, CA).
1096849|NCT00570349|B4|Baseline|Total|Total of all reporting groups
1096850|NCT00570349|B3|Baseline|Nitrogen|Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
1096854|NCT00570349|P2|Participant Flow|Inhaled Nitric Oxide High Dose|High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours.
1096855|NCT00570349|P1|Participant Flow|Inhaled Nitric Oxide Low Dose|Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours
1096856|NCT00570349|O3|Outcome|Nitrogen|Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
1096857|NCT00570349|O2|Outcome|Inhaled Nitric Oxide High Dose|High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours.
1096858|NCT00570349|O1|Outcome|Inhaled Nitric Oxide Low Dose|Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours
1096859|NCT00570349|O3|Outcome|Nitrogen|Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
1096860|NCT00570349|O2|Outcome|Inhaled Nitric Oxide High Dose|High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours.
1096861|NCT00570349|O1|Outcome|Inhaled Nitric Oxide Low Dose|Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours
1096862|NCT00570349|O3|Outcome|Nitrogen|Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
1096863|NCT00570349|O2|Outcome|Inhaled Nitric Oxide High Dose|High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours.
1096864|NCT00570349|O1|Outcome|Inhaled Nitric Oxide Low Dose|Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours
1096865|NCT00570349|E3|Reported Event|Nitrogen|Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
1096866|NCT00570349|E2|Reported Event|Inhaled Nitric Oxide High Dose|High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours.
1096867|NCT00570349|E1|Reported Event|Inhaled Nitric Oxide Low Dose|Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours
1096868|NCT00570310|B3|Baseline|Total|Total of all reporting groups
1096869|NCT00570310|B2|Baseline|Placebo|Patients who were randomized to placebo and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.
1096870|NCT00570310|B1|Baseline|Pregabalin|Patients who were randomized to pregabalin and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.
1096871|NCT00570310|P2|Participant Flow|Placebo|Patients were treated with placebo starting at randomization.
1096872|NCT00570310|P1|Participant Flow|Pregabalin|Patients were treated with pregabalin (up to 600 mg/day by mouth (po)) for the entire double-blind period.
1096873|NCT00570310|O2|Outcome|Placebo|Patients who were randomized to placebo and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.
1096874|NCT00570310|O1|Outcome|Pregabalin|Patients who were randomized to pregabalin and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.
1096875|NCT00570310|O2|Outcome|Placebo|Patients who were randomized to placebo and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.
1096877|NCT00570310|E2|Reported Event|Placebo|Patients were treated with placebo starting at randomization.
1097107|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
1096880|NCT00570232|P1|Participant Flow|Tarceva|"All patients will be prescribed Tarceva 150mg daily~Erlotinib: 150 mg per day by mouth for 12 months"
1096881|NCT00570232|O1|Outcome|Tarceva|"All patients will be prescribed Tarceva 150mg daily~Erlotinib: 150 mg per day by mouth for 12 months"
1096882|NCT00570232|O1|Outcome|Tarceva|"All patients will be prescribed Tarceva 150mg daily~Erlotinib: 150 mg per day by mouth for 12 months"
1096883|NCT00570232|O1|Outcome|Tarceva|"All patients will be prescribed Tarceva 150mg daily~Erlotinib: 150 mg per day by mouth for 12 months"
1096884|NCT00570232|E1|Reported Event|Tarceva|"All patients will be prescribed Tarceva 150mg daily~Erlotinib: 150 mg per day by mouth for 12 months"
1096885|NCT00570141|B1|Baseline|OASIS Wound Matrix (Oasis)|All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
1096886|NCT00570141|P1|Participant Flow|OASIS Wound Matrix (Oasis)|All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
1096887|NCT00570141|O1|Outcome|OASIS Wound Matrix (Oasis)|All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
1096888|NCT00570141|O1|Outcome|OASIS Wound Matrix (Oasis)|All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
1096889|NCT00570141|E1|Reported Event|OASIS Wound Matrix (Oasis)|All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
1096890|NCT00570089|B1|Baseline|All Study Participants|Participants who were randomized to receive either Study drug Ranexa or Placebo.
1096891|NCT00570089|P2|Participant Flow|Placebo Then Study Drug Ranexa|20 subjects (10 in study drug arm and 10 in placebo arm) completed period 1. In period 2, the 10 subjects who were on study drug in period 1 were on placebo arm in period 2, and the 10 subjects who were on placebo arm in period 1 were on study drug arm in period 2. The 20 subjects had a 2-week wash out in between.
1096892|NCT00570089|P1|Participant Flow|Study Drug Ranexa Then Placebo|20 subjects (10 in study drug arm and 10 in placebo arm) completed period 1. In period 2, the 10 subjects who were on study drug in period 1 were on placebo arm in period 2, and the 10 subjects who were on placebo arm in period 1 were on study drug arm in period 2. The 20 subjects had a 2-week wash out in between.
1096893|NCT00570089|O2|Outcome|Placebo|Placebo arm
1096894|NCT00570089|O1|Outcome|Study Drug|Study drug Ranexa arm
1097608|NCT00567840|O4|Outcome|PA-824 1200 mg|PA-824: 1200 mg per day for 14 consecutive days
1096895|NCT00570089|O2|Outcome|Placebo - CMRs (10 CMR 1 and 10 CMR 2)|CMRs (CMR 1 and CMR 2) were performed to test the efficiency of the treatment of the study drug.
1096896|NCT00570089|O1|Outcome|Study Drug Ranexa - CMRs (10 CMR 1 and 10 CMR 2)|CMRs (CMR 1 and CMR 2) were performed to test the efficiency of the treatment of the study drug.
1096897|NCT00570089|E2|Reported Event|Placebo|Placebo arm
1096898|NCT00570089|E1|Reported Event|Study Drug|Study drug Ranexa arm
1096899|NCT00570037|B3|Baseline|Total|Total of all reporting groups
1096900|NCT00570037|B2|Baseline|Hospital With No Immunization Program|
1096901|NCT00570037|B1|Baseline|Hospital With Immunization Program|
1096902|NCT00570037|P2|Participant Flow|Hospital With No Immunization Program|
1096903|NCT00570037|P1|Participant Flow|Hospital With Immunization Program|
1096904|NCT00570037|O2|Outcome|Hospital With No Immunization Program|
1096905|NCT00570037|O1|Outcome|Hospital With Immunization Program|
1096906|NCT00570037|O2|Outcome|Hospital With No Immunization Program|
1096907|NCT00570037|O1|Outcome|Hospital With Immunization Program|
1096908|NCT00570037|O2|Outcome|Hospital With No Immunization Program|
1096909|NCT00570037|O1|Outcome|Hospital With Immunization Program|
1096910|NCT00570037|E2|Reported Event|Hospital With No Immunization Program|
1096911|NCT00570037|E1|Reported Event|Hospital With Immunization Program|
1096912|NCT00569946|B1|Baseline|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
1096913|NCT00569946|P1|Participant Flow|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
1096914|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
1096915|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
1096916|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
1096935|NCT00569855|E1|Reported Event|Subjects Who Received Study Drug|Subjects less than 20 kgs who received phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery with a dose range between 0.125mg/kg to 0.5mg/kg
1096936|NCT00569803|B9|Baseline|Total|Total of all reporting groups
1096937|NCT00569803|B8|Baseline|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
1096917|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
1096918|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
1096919|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
1096920|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
1096921|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
1096950|NCT00569803|P3|Participant Flow|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
1096922|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
1096923|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
1096924|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
1096925|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
1096926|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
1096927|NCT00569946|E1|Reported Event|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
1096928|NCT00569868|B1|Baseline|Velcade|Velcade IV, 1.3 mg/m2, days 1,4,8, and 11: Treatment on this study will last 2 cycles. Each cycle consists of 3 weeks, or 21 days, then followed every three months for approximately 2 years.
1096929|NCT00569868|P1|Participant Flow|Velcade|Velcade IV, 1.3 mg/m2, days 1,4,8, and 11: Treatment on this study will last 2 cycles. Each cycle consists of 3 weeks, or 21 days, then followed every three months for approximately 2 years.
1096930|NCT00569868|O1|Outcome|Velcade|Velcade IV, 1.3 mg/m2, days 1,4,8, and 11: Treatment on this study will last 2 cycles. Each cycle consists of 3 weeks, or 21 days, then followed every three months for approximately 2 years.
1096931|NCT00569868|E1|Reported Event|Velcade|Velcade IV, 1.3 mg/m2, days 1,4,8, and 11: Treatment on this study will last 2 cycles. Each cycle consists of 3 weeks, or 21 days, then followed every three months for approximately 2 years.
1096932|NCT00569855|B1|Baseline|Subjects Who Received Study Drug|Subjects less than 20 kgs who received phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery with a dose range between 0.125mg/kg to 0.5mg/kg
1096933|NCT00569855|P1|Participant Flow|Subjects Who Received Study Drug|Subjects less than 20 kgs who received phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery with a dose range between 0.125mg/kg to 0.5mg/kg
1096934|NCT00569855|O1|Outcome|Subjects Who Received Study Drug|Subjects less than 20 kgs who received phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery with a dose range between 0.125mg/kg to 0.5mg/kg
1096938|NCT00569803|B7|Baseline|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
1096939|NCT00569803|B6|Baseline|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1096940|NCT00569803|B5|Baseline|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1096941|NCT00569803|B4|Baseline|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1096942|NCT00569803|B3|Baseline|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
1096943|NCT00569803|B2|Baseline|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
1096944|NCT00569803|B1|Baseline|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
1096945|NCT00569803|P8|Participant Flow|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
1096946|NCT00569803|P7|Participant Flow|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
1096947|NCT00569803|P6|Participant Flow|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1096948|NCT00569803|P5|Participant Flow|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1096949|NCT00569803|P4|Participant Flow|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1097609|NCT00567840|O3|Outcome|PA-824 1000 mg|PA-824: 1000 mg per day for 14 consecutive days
1096951|NCT00569803|P2|Participant Flow|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
1096952|NCT00569803|P1|Participant Flow|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
1096953|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
1096954|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1096955|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1096956|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1096957|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
1096958|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
1096959|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
1096960|NCT00569803|O8|Outcome|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
1096961|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
1096962|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1096963|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1096964|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1096965|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
1096966|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
1096967|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
1096968|NCT00569803|O8|Outcome|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
1096969|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
1096970|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1096971|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1096972|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1096973|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
1096974|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
1099761|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
1096975|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
1096976|NCT00569803|O8|Outcome|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
1096977|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
1096978|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1096979|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1096980|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1096981|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
1096982|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
1096983|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
1096984|NCT00569803|O8|Outcome|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
1096985|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
1096986|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1096987|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1102458|NCT00556543|O1|Outcome|All Study Subjects|
1096988|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1096989|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
1096990|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
1096991|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
1096992|NCT00569803|O8|Outcome|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
1096993|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
1096994|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1096995|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1096996|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1096997|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
1096998|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
1096999|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
1097000|NCT00569803|O8|Outcome|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
1097001|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
1097002|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1097003|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1097004|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1097005|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
1097006|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
1097007|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
1097008|NCT00569803|O8|Outcome|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
1097009|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
1097010|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1097011|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1097095|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
1097096|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
1097012|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1097013|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
1097014|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
1097015|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
1097016|NCT00569803|O2|Outcome|2 Injection Sites|Participants receiving treatments of 150mg, 200mg and 250mg Subcutaneous Belatacept were injected at 2 sites; one injection equal to half the total dose was delivered to the anterior thigh on each side.
1097017|NCT00569803|O1|Outcome|1 Injection Site|Participants receiving treatments of 50mg, 100mg and 125mg Subcutaneous Belatacept were injected at 1 site at the anterior thigh.
1097018|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1097019|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1097020|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1097021|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
1097022|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
1097023|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
1097025|NCT00569803|O1|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
1097026|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1097027|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1097028|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1097029|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
1097030|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
1097031|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
1097032|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
1097033|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1097034|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1097035|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1097036|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
1097037|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
1097038|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
1097039|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
1097040|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1097041|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1097042|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1097043|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
1097044|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
1097045|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
1097046|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
1097047|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1099762|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
1097048|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1097049|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1097050|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
1097051|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
1097052|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
1097053|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
1097054|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1097055|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1097056|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1097057|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
1097058|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
1097059|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
1097060|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
1097061|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1097062|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1097063|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1097064|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
1097065|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
1097066|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
1097067|NCT00569803|E9|Reported Event|All Belatacept|All participants treated with IV or SC Belatacept of any dose
1097068|NCT00569803|E8|Reported Event|PLACEBO|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
1097069|NCT00569803|E7|Reported Event|Belatacept 125mg IV|125 mg Belatacept intravenous (IV) injection
1097070|NCT00569803|E6|Reported Event|Belatacept 250mg SC|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1097071|NCT00569803|E5|Reported Event|Belatacept 200mg SC|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1097072|NCT00569803|E4|Reported Event|Belatacept 150mg SC|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
1097073|NCT00569803|E3|Reported Event|Belatacept 125mg SC|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
1097074|NCT00569803|E2|Reported Event|Belatacept 100mg SC|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
1097075|NCT00569803|E1|Reported Event|Belatacept 50mg SC|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
1097076|NCT00569777|B3|Baseline|Total|Total of all reporting groups
1097077|NCT00569777|B2|Baseline|Placebo|etafilcon A contact lens without ketotifen
1097078|NCT00569777|B1|Baseline|K-lens|etafilcon A contact lens with ketotifen.
1097079|NCT00569777|P2|Participant Flow|Placebo|etafilcon A contact lens without ketotifen
1097080|NCT00569777|P1|Participant Flow|K-lens|etafilcon A contact lens with ketotifen.
1097081|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
1097082|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
1097083|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
1097084|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
1097085|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
1097086|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
1097087|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
1097088|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
1097089|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
1097090|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
1097091|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
1097092|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
1097093|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
1097094|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
1097108|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
1097109|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
1097110|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
1097111|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
1097112|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
1097113|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
1097114|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
1097115|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
1097116|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
1097117|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
1097118|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
1097119|NCT00569777|E2|Reported Event|Placebo|etafilcon A contact lens without ketotifen
1097120|NCT00569777|E1|Reported Event|K-lens|etafilcon A contact lens with ketotifen.
1097121|NCT00569673|B1|Baseline|Docetaxel Plus Trabectedin|Docetaxel 60 mg/m2 IV over 1 hour followed by trabectedin (YONDELIS„µ, R279741) formerly referred to as, ET-743) 1.1 mg/m2 over 3 hours with Filgrastim (G-CSF, NSC #614629), Pegfilgrastim (G-CSF, NSC #725961) or Sargramostim (GM-CSF, NSC #613795) every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy.
1097122|NCT00569673|P1|Participant Flow|Docetaxel Plus Trabectedin|Docetaxel 60 mg/m2 IV over 1 hour followed by trabectedin (YONDELIS„µ, R279741) formerly referred to as, ET-743) 1.1 mg/m2 over 3 hours with Filgrastim (G-CSF, NSC #614629), Pegfilgrastim (G-CSF, NSC #725961) or Sargramostim (GM-CSF, NSC #613795) every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy.
1097123|NCT00569673|O1|Outcome|Docetaxel Plus Trabectedin|Docetaxel 60 mg/m2 IV over 1 hour followed by trabectedin (YONDELIS„µ, R279741) formerly referred to as, ET-743) 1.1 mg/m2 over 3 hours with Filgrastim (G-CSF, NSC #614629), Pegfilgrastim (G-CSF, NSC #725961) or Sargramostim (GM-CSF, NSC #613795) every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy.
1097208|NCT00569192|O3|Outcome|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
1097124|NCT00569673|E1|Reported Event|Docetaxel Plus Trabectedin|Docetaxel 60 mg/m2 IV over 1 hour followed by trabectedin (YONDELIS„µ, R279741) formerly referred to as, ET-743) 1.1 mg/m2 over 3 hours with Filgrastim (G-CSF, NSC #614629), Pegfilgrastim (G-CSF, NSC #725961) or Sargramostim (GM-CSF, NSC #613795) every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy.
1097125|NCT00569660|B1|Baseline|Azacitidine|75 mg/m^2 Subcutaneous daily for 7 days every 4 weeks
1097126|NCT00569660|P1|Participant Flow|Azacitidine|75 mg/m^2 Subcutaneous daily for 7 days every 4 weeks
1097127|NCT00569660|O1|Outcome|Azacitidine|75 mg/m^2 Subcutaneous daily for 7 days every 4 weeks
1097128|NCT00569660|E1|Reported Event|Azacitidine|75 mg/m^2 Subcutaneous daily for 7 days every 4 weeks
1097129|NCT00569582|B1|Baseline|Mifepristone|Mifepristone was administered at doses of 300-1200 mg daily.
1097130|NCT00569582|P1|Participant Flow|Mifepristone|Mifepristone was administered at doses of 300-1200 mg daily.
1097131|NCT00569582|O1|Outcome|Mifepristone|Mifepristone was administered at doses of 300-1200 mg daily.
1097132|NCT00569582|O1|Outcome|Mifepristone|Mifepristone was administered at doses of 300-1200 mg daily.
1097133|NCT00569582|E1|Reported Event|Mifepristone|Mifepristone was administered at doses of 300-1200 mg daily.
1097134|NCT00569530|B3|Baseline|Total|Total of all reporting groups
1097135|NCT00569530|B2|Baseline|Sham (no Treatment)|"Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Sham Infants will not receive additional doses of Infasurf."
1097136|NCT00569530|B1|Baseline|Treatment Surfactant (Infasurf) ONY, NY|"Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Infasurf (ONY Inc.): Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14."
1097137|NCT00569530|P2|Participant Flow|Sham (no Treatment)|"Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Sham Infants will not receive additional doses of Infasurf."
1097138|NCT00569530|P1|Participant Flow|Treatment Surfactant (Infasurf) ONY, NY|"Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Infasurf (ONY Inc.): Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14."
1097139|NCT00569530|O2|Outcome|Sham (no Treatment)|"Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Sham Infants will not receive additional doses of Infasurf."
1097140|NCT00569530|O1|Outcome|Treatment Surfactant (Infasurf) ONY, NY|"Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Infasurf (ONY Inc.): Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14."
1097141|NCT00569530|O2|Outcome|Sham (no Treatment)|"Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Sham Infants will not receive additional doses of Infasurf."
1097142|NCT00569530|O1|Outcome|Treatment Surfactant (Infasurf) ONY, NY|"Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Infasurf (ONY Inc.): Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14."
1097143|NCT00569530|E2|Reported Event|Sham (no Treatment)|"Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Sham Infants will not receive additional doses of Infasurf."
1097144|NCT00569530|E1|Reported Event|Treatment Surfactant (Infasurf) ONY, NY|"Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Infasurf (ONY Inc.): Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14."
1097145|NCT00569374|B1|Baseline|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
1097146|NCT00569374|P1|Participant Flow|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
1097147|NCT00569374|O1|Outcome|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
1097148|NCT00569374|O1|Outcome|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
1097149|NCT00569374|O1|Outcome|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
1097150|NCT00569374|O1|Outcome|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
1097151|NCT00569374|O1|Outcome|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
1097152|NCT00569374|O1|Outcome|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
1097153|NCT00569374|O1|Outcome|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
1097154|NCT00569374|E1|Reported Event|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
1097155|NCT00569270|B1|Baseline|Entire Study Population|Includes groups randomized to receive placebo first and Tiotropium first.
1097156|NCT00569270|P2|Participant Flow|Placebo First, Then Tiotropium Bromide 18 µg|tiotropium 18 µg capsule for 1 month versus placebo. To study bronchodilation and effect following metronome paced hyperventilation and induced dynamic hyperinflation of active tiotropium versus placebo
1097157|NCT00569270|P1|Participant Flow|Tiotropium 18 µg Capsule First, Then Placebo|tiotropium 18 µg capsule for 1 month versus placebo. To study bronchodilation and effect following metronome paced hyperventilation and induced dynamic hyperinflation of active tiotropium versus placebo
1097158|NCT00569270|O1|Outcome|Lung CT Scored Emphysema and FRC/TLC|Extent of lung CT scored emphysema (percent of lung) and lung function of FRC/TLC (functional residual capacity(L)/total lung capacity (L) after tiotropium
1097159|NCT00569270|O2|Outcome|TLC (L) 2h Post Tiotropium|Total Lung Capacity (L)following metronome paced hyperventilation induced dynamic hyperinflation post 30 days plus 2h tiotropium
1097160|NCT00569270|O1|Outcome|2h Post Placebo TLC(L)|total lung capacity (L) following metronome paced hyperventilation induced dynamic hyperinflation post 30 days plus 2h placebo
1097161|NCT00569270|O2|Outcome|After DH (Dynamic Hyperinflation|IC (inspiratory capacity) before and after metronome paced hyperventilation induced dynamic hyperinflation post 30 days plus 2h placebo
1097162|NCT00569270|O1|Outcome|Before DH (Dynamic Hyperinflation)|IC (inspiratory capacity) before and after metronome paced hyperventilation and induced dynamic hyperinflation at baseline;
1097163|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
1097164|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
1097165|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first
1097166|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
1097167|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
1097168|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
1097169|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
1097170|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
1097171|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
1097172|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
1097173|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
1097174|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
1097175|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
1097176|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
1097177|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
1097178|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
1097179|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
1097180|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
1097181|NCT00569270|O1|Outcome|Lung CT Scored Emphysema and IC|Extent of lung CT scored emphysema (percent of lung) and lung function of IC (inspiratory capacity, L) after tiotropium.
1097182|NCT00569270|O2|Outcome|Tiotropium 18 µg Capsule, Bronchodilator|Includes groups randomized to receive placebo first and Tiotropium first.
1097183|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
1097184|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
1097185|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
1097186|NCT00569270|O1|Outcome|Lung CT Scored Emphysema and FEV1|Extent of lung CT scored emphysema and and lung function of FEV1(l) after tiotropium
1097187|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
1097188|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
1097189|NCT00569270|E2|Reported Event|Placebo|Adverse events after placebo. (30 enrolled subjects, one drop-out)
1097190|NCT00569270|E1|Reported Event|Tiotropium Bromide 18 µg, Capsule,|tiotropium 18 µg capsule for 1 month. To study bronchodilation and effect following metronome paced hyperventilation and induced dynamic hyperinflation of active tiotropium. (30 enrolled subjects, one drop-out)
1097191|NCT00569231|B1|Baseline|Candida Antigen|All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
1097192|NCT00569231|P1|Participant Flow|Candida Antigen|All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
1097193|NCT00569231|O1|Outcome|Candida Antigen|All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
1097432|NCT00568386|P2|Participant Flow|Optive Drops Then Systane Drops|Optive Drops then Systane Drops
1097194|NCT00569231|O1|Outcome|Candida Antigen|All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
1097195|NCT00569231|O1|Outcome|Candida Antigen|All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
1097196|NCT00569231|O1|Outcome|Candida Antigen|All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
1097197|NCT00569231|E1|Reported Event|Candida Antigen|All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
1097198|NCT00569192|B4|Baseline|Total|Total of all reporting groups
1097199|NCT00569192|B3|Baseline|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
1097200|NCT00569192|B2|Baseline|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
1097201|NCT00569192|B1|Baseline|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
1097202|NCT00569192|P3|Participant Flow|0.25 mg MAP0010|0.125mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
1097203|NCT00569192|P2|Participant Flow|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
1097204|NCT00569192|P1|Participant Flow|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
1097205|NCT00569192|O3|Outcome|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
1097206|NCT00569192|O2|Outcome|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
1097207|NCT00569192|O1|Outcome|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
1102459|NCT00556543|O1|Outcome|All Study Subjects|
1097209|NCT00569192|O2|Outcome|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
1097210|NCT00569192|O1|Outcome|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
1097211|NCT00569192|O3|Outcome|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
1097212|NCT00569192|O2|Outcome|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
1097213|NCT00569192|O1|Outcome|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
1097214|NCT00569192|O3|Outcome|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
1097215|NCT00569192|O2|Outcome|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
1097216|NCT00569192|O1|Outcome|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
1097217|NCT00569192|O3|Outcome|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
1097218|NCT00569192|O2|Outcome|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
1097219|NCT00569192|O1|Outcome|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
1097220|NCT00569192|O3|Outcome|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
1097221|NCT00569192|O2|Outcome|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
1097222|NCT00569192|O1|Outcome|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
1097223|NCT00569192|E3|Reported Event|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
1097224|NCT00569192|E2|Reported Event|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
1097225|NCT00569192|E1|Reported Event|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
1097226|NCT00569166|B4|Baseline|Total|Total of all reporting groups
1097227|NCT00569166|B3|Baseline|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
1097228|NCT00569166|B2|Baseline|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
1097229|NCT00569166|B1|Baseline|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
1097230|NCT00569166|P3|Participant Flow|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
1097231|NCT00569166|P2|Participant Flow|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
1097232|NCT00569166|P1|Participant Flow|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
1097233|NCT00569166|O3|Outcome|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
1097234|NCT00569166|O2|Outcome|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
1097235|NCT00569166|O1|Outcome|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
1097236|NCT00569166|E3|Reported Event|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
1097237|NCT00569166|E2|Reported Event|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
1097238|NCT00569166|E1|Reported Event|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
1097239|NCT00569127|B3|Baseline|Total|Total of all reporting groups
1097240|NCT00569127|B2|Baseline|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1097241|NCT00569127|B1|Baseline|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1097242|NCT00569127|P2|Participant Flow|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1097243|NCT00569127|P1|Participant Flow|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1097244|NCT00569127|O2|Outcome|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1097245|NCT00569127|O1|Outcome|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1097393|NCT00568555|O1|Outcome|Low Dose Naltrexone|All participants during the low dose naltrexone condition
1097246|NCT00569127|O2|Outcome|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1097247|NCT00569127|O1|Outcome|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1097248|NCT00569127|O2|Outcome|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1097249|NCT00569127|O1|Outcome|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1097250|NCT00569127|O2|Outcome|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1097251|NCT00569127|O1|Outcome|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1097252|NCT00569127|O2|Outcome|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1097253|NCT00569127|O1|Outcome|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1097254|NCT00569127|O2|Outcome|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1097255|NCT00569127|O1|Outcome|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1097256|NCT00569127|E2|Reported Event|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1097257|NCT00569127|E1|Reported Event|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1097258|NCT00569010|B5|Baseline|Total|Total of all reporting groups
1097259|NCT00569010|B4|Baseline|High-Dose Ara-C + AZA-Level 1|High-dose Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65 years); AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
1097260|NCT00569010|B3|Baseline|High-Dose Ara-C + AZA-Level 0|Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65years); AZA: 37.5 mg/m^2 IV Over 20-30 minutes Daily for 7 Days
1097261|NCT00569010|B2|Baseline|Low-Dose Ara-C + AZA-Level 1|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
1097262|NCT00569010|B1|Baseline|Low-Dose Ara-C + AZA-Level 0|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days; Azacitidine (AZA): 37.5 mg/m^2 intravenous (IV) Over 20-30 minutes Daily for 7 Days
1097263|NCT00569010|P4|Participant Flow|High-Dose Ara-C + AZA-Level 1|High-dose Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65 years); AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
1097264|NCT00569010|P3|Participant Flow|High-Dose Ara-C + AZA-Level 0|Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65years); AZA: 37.5 mg/m^2 IV Over 20-30 minutes Daily for 7 Days
1097265|NCT00569010|P2|Participant Flow|Low-Dose Ara-C + AZA-Level 1|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
1097266|NCT00569010|P1|Participant Flow|Low-Dose Ara-C + AZA-Level 0|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days; Azacitidine (AZA): 37.5 mg/m^2 intravenous (IV) Over 20-30 minutes Daily for 7 Days
1097267|NCT00569010|O4|Outcome|High-Dose Ara-C + AZA-Level 1|High-dose Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65 years); AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
1097268|NCT00569010|O3|Outcome|High-Dose Ara-C + AZA-Level 0|Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65years); AZA: 37.5 mg/m^2 IV Over 20-30 minutes Daily for 7 Days
1097269|NCT00569010|O2|Outcome|Low-Dose Ara-C + AZA-Level 1|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
1097270|NCT00569010|O1|Outcome|Low-Dose Ara-C + AZA-Level 0|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days; Azacitidine (AZA): 37.5 mg/m^2 intravenous (IV) Over 20-30 minutes Daily for 7 Days
1097271|NCT00569010|E4|Reported Event|High-Dose Ara-C + AZA-Level 1|High-dose Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65 years); AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
1097272|NCT00569010|E3|Reported Event|High-Dose Ara-C + AZA-Level 0|Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65years); AZA: 37.5 mg/m^2 IV Over 20-30 minutes Daily for 7 Days
1097273|NCT00569010|E2|Reported Event|Low-Dose Ara-C + AZA-Level 1|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
1097274|NCT00569010|E1|Reported Event|Low-Dose Ara-C + AZA-Level 0|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days; Azacitidine (AZA): 37.5 mg/m^2 intravenous (IV) Over 20-30 minutes Daily for 7 Days
1097275|NCT00568958|B3|Baseline|Total|Total of all reporting groups
1097276|NCT00568958|B2|Baseline|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
1097277|NCT00568958|B1|Baseline|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
1097278|NCT00568958|P2|Participant Flow|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
1097279|NCT00568958|P1|Participant Flow|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
1097280|NCT00568958|O2|Outcome|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
1097281|NCT00568958|O1|Outcome|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
1097282|NCT00568958|O2|Outcome|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
1097283|NCT00568958|O1|Outcome|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
1097297|NCT00568854|B2|Baseline|Participants Without Diabetes|"Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG.~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
1097284|NCT00568958|O2|Outcome|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
1097285|NCT00568958|O1|Outcome|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
1097286|NCT00568958|O2|Outcome|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
1097287|NCT00568958|O1|Outcome|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
1097288|NCT00568958|O2|Outcome|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
1097289|NCT00568958|O1|Outcome|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
1097290|NCT00568958|O2|Outcome|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
1097291|NCT00568958|O1|Outcome|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
1097292|NCT00568958|O2|Outcome|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
1097293|NCT00568958|O1|Outcome|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
1097294|NCT00568958|E2|Reported Event|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
1097295|NCT00568958|E1|Reported Event|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
1097296|NCT00568854|B3|Baseline|Total|Total of all reporting groups
1097378|NCT00568685|O1|Outcome|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
1099763|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
1097298|NCT00568854|B1|Baseline|Participants With Diabetes|"Persons with diagnosis of diabetes. Received biological intervention: BCG~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
1097299|NCT00568854|P2|Participant Flow|Participants Without Diabetes|"Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG.~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
1097300|NCT00568854|P1|Participant Flow|Participants With Diabetes|"Persons with diagnosis of diabetes. Received biological intervention: BCG~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
1097301|NCT00568854|O2|Outcome|Participants Without Diabetes|"Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG.~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
1097302|NCT00568854|O1|Outcome|Participants With Diabetes|"Persons with diagnosis of diabetes. Received biological intervention: BCG~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
1097303|NCT00568854|O2|Outcome|Participants Without Diabetes|"Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG.~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
1097394|NCT00568555|O2|Outcome|Placebo - Sugar Pill|All participants during the placebo condition
1097304|NCT00568854|O1|Outcome|Participants With Diabetes|"Persons with diagnosis of diabetes. Received biological intervention: BCG~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
1097305|NCT00568854|E2|Reported Event|Participants Without Diabetes|"Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG.~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
1097306|NCT00568854|E1|Reported Event|Participants With Diabetes|"Persons with diagnosis of diabetes. Received biological intervention: BCG~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
1097307|NCT00568776|B5|Baseline|Total|Total of all reporting groups
1097308|NCT00568776|B4|Baseline|ELND005 2000 mg BID|oral administration for 78 weeks
1097309|NCT00568776|B3|Baseline|ELND005 1000 mg BID|oral administration for 78 weeks
1097310|NCT00568776|B2|Baseline|ELND005 250 mg BID|oral administration for 78 weeks
1097311|NCT00568776|B1|Baseline|Placebo BID|oral administration for 78 weeks
1097312|NCT00568776|P4|Participant Flow|ELND005 2000 mg BID|oral administration for 78 weeks
1097313|NCT00568776|P3|Participant Flow|ELND005 1000 mg BID|oral administration for 78 weeks
1097314|NCT00568776|P2|Participant Flow|ELND005 250 mg BID|oral administration for 78 weeks
1097315|NCT00568776|P1|Participant Flow|Placebo BID|oral administration for 78 weeks
1097316|NCT00568776|O4|Outcome|ELND005 2000 mg BID|oral administration for 78 weeks
1097317|NCT00568776|O3|Outcome|ELND005 1000 mg BID|oral administration for 78 weeks
1097318|NCT00568776|O2|Outcome|ELND005 250 mg BID|oral administration for 78 weeks
1097319|NCT00568776|O1|Outcome|Placebo BID|oral administration for 78 weeks
1097320|NCT00568776|O4|Outcome|ELND005 2000 mg BID|oral administration for 78 weeks
1097321|NCT00568776|O3|Outcome|ELND005 1000 mg BID|oral administration for 78 weeks
1097322|NCT00568776|O2|Outcome|ELND005 250 mg BID|oral administration for 78 weeks
1097323|NCT00568776|O1|Outcome|Placebo BID|oral administration for 78 weeks
1097324|NCT00568776|O4|Outcome|ELND005 2000 mg BID|oral administration for 78 weeks
1097325|NCT00568776|O3|Outcome|ELND005 1000 mg BID|oral administration for 78 weeks
1097326|NCT00568776|O2|Outcome|ELND005 250 mg BID|oral administration for 78 weeks
1097327|NCT00568776|O1|Outcome|Placebo BID|oral administration for 78 weeks
1097328|NCT00568776|O4|Outcome|ELND005 2000 mg BID|oral administration for 78 weeks
1097329|NCT00568776|O3|Outcome|ELND005 1000 mg BID|oral administration for 78 weeks
1097330|NCT00568776|O2|Outcome|ELND005 250 mg BID|oral administration for 78 weeks
1097331|NCT00568776|O1|Outcome|Placebo BID|oral administration for 78 weeks
1097332|NCT00568776|O4|Outcome|ELND005 2000 mg BID|oral administration for 78 weeks
1097333|NCT00568776|O3|Outcome|ELND005 1000 mg BID|oral administration for 78 weeks
1097334|NCT00568776|O2|Outcome|ELND005 250 mg BID|oral administration for 78 weeks
1097335|NCT00568776|O1|Outcome|Placebo BID|oral administration for 78 weeks
1097336|NCT00568776|O4|Outcome|ELND005 2000 mg BID|oral administration for 78 weeks
1097337|NCT00568776|O3|Outcome|ELND005 1000 mg BID|oral administration for 78 weeks
1097338|NCT00568776|O2|Outcome|ELND005 250 mg BID|oral administration for 78 weeks
1097339|NCT00568776|O1|Outcome|Placebo BID|oral administration for 78 weeks
1097340|NCT00568776|O4|Outcome|ELND005 2000 mg BID|oral administration for 78 weeks
1097341|NCT00568776|O3|Outcome|ELND005 1000 mg BID|oral administration for 78 weeks
1097342|NCT00568776|O2|Outcome|ELND005 250 mg BID|oral administration for 78 weeks
1097343|NCT00568776|O1|Outcome|Placebo BID|oral administration for 78 weeks
1097344|NCT00568776|E4|Reported Event|ELND005 2000 mg BID|oral administration for 78 weeks
1097345|NCT00568776|E3|Reported Event|ELND005 1000 mg BID|oral administration for 78 weeks
1097346|NCT00568776|E2|Reported Event|ELND005 250 mg BID|oral administration for 78 weeks
1097347|NCT00568776|E1|Reported Event|Placebo BID|oral administration for 78 weeks
1097348|NCT00568685|B4|Baseline|Total|Total of all reporting groups
1097349|NCT00568685|B3|Baseline|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
1097350|NCT00568685|B2|Baseline|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
1097351|NCT00568685|B1|Baseline|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
1097352|NCT00568685|P3|Participant Flow|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
1097353|NCT00568685|P2|Participant Flow|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
1097354|NCT00568685|P1|Participant Flow|Atomoxetine 0.2 Milligrams Per Kilogram, Per Day (mg/kg/Day)|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
1097355|NCT00568685|O3|Outcome|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
1097356|NCT00568685|O2|Outcome|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
1097357|NCT00568685|O1|Outcome|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
1097358|NCT00568685|O3|Outcome|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
1097359|NCT00568685|O2|Outcome|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
1097360|NCT00568685|O1|Outcome|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
1097361|NCT00568685|O3|Outcome|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
1097362|NCT00568685|O2|Outcome|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
1097363|NCT00568685|O1|Outcome|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
1097364|NCT00568685|O3|Outcome|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
1097365|NCT00568685|O2|Outcome|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
1097366|NCT00568685|O1|Outcome|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
1097367|NCT00568685|O3|Outcome|>0.85 mg/kg/Day|Patients received atomoxetine >0.85 mg/kg/day
1097368|NCT00568685|O2|Outcome|0.36-0.85 mg/kg/Day|Patients received atomoxetine 0.36-0.85 mg/kg/day
1097369|NCT00568685|O1|Outcome|0-0.35 mg/kg/Day|Patients received atomoxetine 0-0.35 mg/kg/day
1097370|NCT00568685|O3|Outcome|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
1097371|NCT00568685|O2|Outcome|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
1097372|NCT00568685|O1|Outcome|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
1097373|NCT00568685|O3|Outcome|> 0.85 mg/kg/Day|Patients received atomoxetine >0.85 mg/kg/day
1097374|NCT00568685|O2|Outcome|0.36-0.85 mg/kg/Day|Patients received atomoxetine 0.36-0.85 mg/kg/day
1097375|NCT00568685|O1|Outcome|0-0.35 mg/kg/Day|Patients received atomoxetine 0-0.35 mg/kg/day
1097376|NCT00568685|O3|Outcome|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
1097377|NCT00568685|O2|Outcome|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
1097379|NCT00568685|O3|Outcome|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
1097380|NCT00568685|O2|Outcome|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
1097381|NCT00568685|O1|Outcome|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
1097382|NCT00568685|E3|Reported Event|Atomoxetine >0.85 mg/kg/Day|Patients who received the actual dose range listed.
1097383|NCT00568685|E2|Reported Event|Atomoxetine 0.36-0.85 mg/kg/Day|Patients who received the actual dose range listed.
1097384|NCT00568685|E1|Reported Event|Atomoxetine 0.00-0.35 mg/kg/Day|Patients who received the actual dose range listed.
1097385|NCT00568555|B3|Baseline|Total|Total of all reporting groups
1097386|NCT00568555|B2|Baseline|Placebo - Sugar Pill|
1097387|NCT00568555|B1|Baseline|Low Dose Naltrexone|
1097388|NCT00568555|P2|Participant Flow|Placebo - Sugar Pill First|Placebo first, followed by LDN. Placebo (sugar pill) once a day. LDN at 3-4.5mg, once a day.
1097389|NCT00568555|P1|Participant Flow|Low Dose Naltrexone First|Low Dose Naltrexone (LDN) followed by placebo. LDN at 3-4.5mg, once a day. Placebo (sugar pill) once a day.
1097390|NCT00568555|O2|Outcome|Placebo - Sugar Pill|All participant during the placebo condition
1097391|NCT00568555|O1|Outcome|Low Dose Naltrexone|All participants during the low dose naltrexone condition
1097392|NCT00568555|O2|Outcome|Placebo - Sugar Pill|All participant during the placebo condition
1097395|NCT00568555|O1|Outcome|Low Dose Naltrexone|All participants during the Low Dose Naltrexone condition
1097396|NCT00568555|O2|Outcome|Placebo - Sugar Pill|All participant during the placebo condition
1097397|NCT00568555|O1|Outcome|Low Dose Naltrexone|All participants during the low dose naltrexone condition
1097398|NCT00568555|O2|Outcome|Placebo - Sugar Pill|All participants during the placebo condition
1097399|NCT00568555|O1|Outcome|Low Dose Naltrexone|All participants during the Low Dose Naltrexone condition
1097400|NCT00568555|E2|Reported Event|Placebo - Sugar Pill|All participants during the placebo condition
1097401|NCT00568555|E1|Reported Event|Low Dose Naltrexone|All participants during the Low Dose Naltrexone condition
1097402|NCT00568451|B5|Baseline|Total|Total of all reporting groups
1097403|NCT00568451|B4|Baseline|TMZ (Chemo Naive)|Chemotherapy-naive cohorts: Temozolomide (TMZ)
1097404|NCT00568451|B3|Baseline|TMZ (Previously Treated)|Previously chemotherapy treated cohorts: Temozolomide (TMZ)
1097405|NCT00568451|B2|Baseline|PC (Chemo Naive)|Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC)
1097406|NCT00568451|B1|Baseline|PC (Previously Treated)|Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC)
1097407|NCT00568451|P4|Participant Flow|TMZ (Chemo Naive)|Chemotherapy-naive cohorts: Temozolomide (TMZ)
1097408|NCT00568451|P3|Participant Flow|TMZ (Previously Treated)|Previously chemotherapy treated cohorts: Temozolomide (TMZ)
1097409|NCT00568451|P2|Participant Flow|PC (Chemo Naive)|Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC)
1097410|NCT00568451|P1|Participant Flow|PC (Previously Treated)|Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC)
1097411|NCT00568451|O1|Outcome|Overall|TMZ (Previously Treated) and TMZ (Chemo Naive)
1097412|NCT00568451|O1|Outcome|Overall|TMZ (Previously Treated) and TMZ (Chemo Naive)
1097413|NCT00568451|O1|Outcome|Overall|TMZ (Previously Treated) and TMZ (Chemo Naive)
1097414|NCT00568451|O1|Outcome|Overall|TMZ (Previously Treated) and TMZ (Chemo Naive)
1097415|NCT00568451|O1|Outcome|Overall|TMZ (Previously Treated) and TMZ (Chemo Naive)
1097416|NCT00568451|O1|Outcome|Overall|TMZ (Previously Treated) and TMZ (Chemo Naive)
1097417|NCT00568451|O4|Outcome|TMZ (Chemo Naive)|Chemotherapy-naive cohorts: Temozolomide (TMZ)
1097418|NCT00568451|O3|Outcome|TMZ (Previously Treated)|Previously chemotherapy treated cohorts: Temozolomide (TMZ)
1097419|NCT00568451|O2|Outcome|PC (Chemo Naive)|Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC)
1097420|NCT00568451|O1|Outcome|PC (Previously Treated)|Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC)
1097421|NCT00568451|E4|Reported Event|PC (Chemo Naive)|Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC)
1097422|NCT00568451|E3|Reported Event|PC (Previously Treated)|Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC)
1097423|NCT00568451|E2|Reported Event|TMZ (Chemo Naive)|Chemotherapy-naive cohorts: Temozolomide (TMZ)
1097424|NCT00568451|E1|Reported Event|TMZ (Previously Treated)|Previously chemotherapy treated cohorts: Temozolomide (TMZ)
1097425|NCT00568399|B1|Baseline|Sodium Thiosulfate|Treatment with sodium thiosulfate after each dialysis for 5 months and the battery of cardiovascular tests were repeated in those who completed the 5 months of treatment.subjects with high coronary artery calcium scores.
1097426|NCT00568399|P1|Participant Flow|Sodium Thiosulfate|Treatment with sodium thiosulfate after each dialysis for 5 months and the battery of cardiovascular tests were repeated in those who completed the 5 months of treatment.subjects with high coronary artery calcium scores.
1097427|NCT00568399|O1|Outcome|Sodium Thiosulfate|Treatment with sodium thiosulfate after each dialysis for 5 months
1097428|NCT00568399|E1|Reported Event|Sodium Thiosulfate|Treatment with sodium thiosulfate after each dialysis for 5 months and the battery of cardiovascular tests were repeated in those who completed the 5 months of treatment.subjects with high coronary artery calcium scores.
1097429|NCT00568386|B3|Baseline|Total|Total of all reporting groups
1097430|NCT00568386|B2|Baseline|Optive Drops Then Systane Drops|Optive Drops then Systane Drops
1097431|NCT00568386|B1|Baseline|Systane Drops Then Optive Drops|Systane Drops then Optive Drops
1097433|NCT00568386|P1|Participant Flow|Systane Drops Then Optive Drops|Systane Drops then Optive Drops
1097434|NCT00568386|O2|Outcome|Optive Lubricant Eye Drops|Optive Lubricant eye drops
1097435|NCT00568386|O1|Outcome|Systane Lubricant Eye Drops|Systane lubricant eye drops
1097436|NCT00568386|E2|Reported Event|Optive Lubricant Eye Drops|Optive Lubricant eye drops
1097437|NCT00568386|E1|Reported Event|Systane Lubricant Eye Drops|Systane lubricant eye drops
1097438|NCT00568178|B3|Baseline|Total|Total of all reporting groups
1097439|NCT00568178|B2|Baseline|Amlodipine/Placebo|"Amlodipine/Placebo group includes the following: Normotensive patients randomized to losartan. Hypertensive patients randomized to amlodipine and losartan placebo.~Losartan placebo dispensed as tablets or suspension depending on patient weight and ability to swallow tablets. Amlodipine dispensed as suspension for duration of study. Losartan placebo suspension dosing: 0.7 mg/kg/day titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks.~Amlodipine suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan placebo tablet dosing: 25 mg/day orally titrated to 50 mg/day (patients <50 kg) OR 50 mg/day orally titrated to 100 mg/day (patients ≥50 kg) for 12 weeks."
1097440|NCT00568178|B1|Baseline|Losartan|"Four arms combined to 2 groups (losartan & amlodipine/placebo) for reporting and compared those who took losartan to those who did not (i.e., participants took amlodipine and/or placebo).~Losartan group: Normotensives were randomized to losartan and Hypertensives were randomized to losartan & amlodipine placebo.~Losartan dispensed as tablets or suspension depending on patient weight and ability to swallow tablets. Amlodipine placebo dispensed as suspension for duration of study.~Losartan suspension dosing: 0.7 milligram/kilograms/day (mg/kg/day) titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks. Amlodipine placebo suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks."
1097441|NCT00568178|P6|Participant Flow|Enalapril Open Label Extension|"Participants were stratified based on assigned treatment in the double-blind treatment phase and were randomized in a 1:1 ratio to either losartan or enalapril.~Dosing of study medication during the extension phase of the study was at the investigator’s discretion.~Enalapril 2.5-, 5-, 10-, and 20-mg tablets were available for participants able to swallow tablets. For participants unable to swallow tablets, or who weighed <25 kg, enalapril suspension (1 mg/mL) was prepared."
1097442|NCT00568178|P5|Participant Flow|Losartan Open Label Extension|"Participants were stratified based on assigned treatment in the double-blind treatment phase and were randomized in a 1:1 ratio to either losartan or enalapril.~Dosing of study medication during the extension phase of the study was at the investigator’s discretion.~Losartan 25-mg and 50-mg tablets were available for patients able to swallow tablets. For patients unable to swallow tablets, or who weighed <25 kg, losartan suspension (2.5 mg/ml) was prepared."
1097443|NCT00568178|P4|Participant Flow|Amlodipine Double Blind Hypertensive|"Hypertensive patients who were randomized to receive amlodipine and losartan placebo for 12 weeks.~Losartan placebo dispensed as tablets or suspension depending on participant weight and ability to swallow tablets.~Losartan placebo suspension dosing: 0.7 mg/kg/day titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks.~Amlodipine suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan placebo tablet dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks."
1097444|NCT00568178|P3|Participant Flow|Losartan Double Blind Hypertensive|"Hypertensive patients who were randomized to receive losartan and amlodipine placebo for 12 weeks.~Losartan dispensed as tablets or suspension depending on participant weight and ability to swallow tablets. Amlodipine placebo dispensed as suspension for duration of study.~Losartan suspension dosing: 0.7 milligram/kilograms/day (mg/kg/day) titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks. Amlodipine placebo suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan tablet dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks."
1097445|NCT00568178|P2|Participant Flow|Placebo Double Blind Normotensive|"Normotensive participants who were randomized to losartan placebo.~Losartan placebo dispensed as tablets or suspension depending on participant weight and ability to swallow tablets.~Losartan placebo suspension dosing: 0.7 mg/kg/day titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks.~Losartan placebo tablet dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks."
1097446|NCT00568178|P1|Participant Flow|Losartan Double Blind Normortensive|"Normotensive participants who were randomized to losartan.~Losartan dispensed as tablets or suspension depending on participant weight and ability to swallow tablets.~Losartan suspension dosing: 0.7 milligram/kilograms/day (mg/kg/day) titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks. Losartan tablet dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks; or losartan placebo."
1097447|NCT00568178|O2|Outcome|Enalapril Open Label Extension|All participants who completed the 12-week double-blind treatment phase (or discontinued early due to increased proteinuria) were invited to participate in the open-label extension and were randomly assigned using a 1:1 ratio to either losartan or enalapril therapy. The duration of the extension varied, depending on the time of enrollment. All patients who entered the extension continued until the 100th patient completed approximately 3 years of follow-up.
1097448|NCT00568178|O1|Outcome|Losartan Open Label Extension|All participants who completed the 12-week double-blind treatment phase (or discontinued early due to increased proteinuria) were invited to participate in the open-label extension and were randomly assigned using a 1:1 ratio to either losartan or enalapril therapy. The duration of the extension varied, depending on the time of enrollment. All patients who entered the extension continued until the 100th patient completed approximately 3 years of follow-up.
1097472|NCT00568087|E2|Reported Event|Placebo|Identical placebo daily for 8 weeks
1097473|NCT00568087|E1|Reported Event|N-acetylcysteine|N-acetylcysteine daily for 8 weeks
1097449|NCT00568178|O2|Outcome|Enalapril Open Label Extension|All participants who completed the 12-week double-blind treatment phase (or discontinued early due to increased proteinuria) were invited to participate in the open-label extension. Participants were randomized in a 1:1 ratio to either losartan or enalapril therapy. The duration of the extension varied, depending on the time of enrollment. All participants who entered the extension could continue until the 100th participant completed approximately 3 years of follow-up.
1097450|NCT00568178|O1|Outcome|Losartan Open Label Extension|All participants who completed the 12-week double-blind treatment phase (or discontinued early due to increased proteinuria) were invited to participate in the open-label extension. Participants were randomized in a 1:1 ratio to either losartan or enalapril therapy. The duration of the extension varied, depending on the time of enrollment. All participants who entered the extension could continue until the 100th participant completed approximately 3 years of follow-up.
1097451|NCT00568178|O2|Outcome|Amlodipine-Hypertensive Participants|Group includes hypertensive participants who were randomized to amlodipine and losartan placebo.
1097452|NCT00568178|O1|Outcome|Losartan-Hypertensive Participants|Group includes hypertensive participants who were randomized to losartan and amlodipine placebo.
1097453|NCT00568178|O2|Outcome|Amlodipine-Hypertensive Participants|Group includes hypertensive participants who were randomized to amlodipine and losartan placebo.
1097454|NCT00568178|O1|Outcome|Losartan-Hypertensive Participants|Group includes hypertensive participants who were randomized to losartan and amlodipine placebo.
1097486|NCT00568022|B1|Baseline|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
1097510|NCT00568022|O2|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
1102460|NCT00556543|O1|Outcome|All Study Subjects|
1097455|NCT00568178|O2|Outcome|Amlodipine/Placebo|"Amlodipine/Placebo group includes the following: Normotensive patients randomized to losartan placebo. Hypertensive patients randomized to amlodipine and losartan placebo.~Losartan placebo dispensed as tablets or suspension depending on patient weight and ability to swallow tablets. Amlodipine dispensed as suspension for duration of study. Losartan placebo suspension dosing: 0.7 mg/kg/day titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks.~Amlodipine suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan placebo tablet dosing: 25 mg/day orally titrated to 50 mg/day (patients <50 kg) OR 50 mg/day orally titrated to 100 mg/day (patients ≥50 kg) for 12 weeks."
1097456|NCT00568178|O1|Outcome|Losartan|Participants were randomized in a 1:1 ratio within each stratum: hypertensive patients (6 to 17 years of age) were randomized to either amlodipine or losartan; normotensive patients (1 to 17 years of age) were randomized to either placebo or losartan. Losartan (or placebo) therapy was administered orally, in tablet or suspension form, at an initial dose of approximately 0.7 mg/kg once daily (up to 50 or 100 mg total daily dose, weight-dependent). Participants who were randomized to losartan were assigned to a normotensive or hypertensive group, based on clinical profile.
1097457|NCT00568178|E4|Reported Event|Enalapril: Open-Label Extension|"Please note that the open label participant population was derived exclusively from the original base study population. There was no additional recruitment.~Participants were randomized to either losartan or enalapril, administered in an unblinded fashion (placebo was not used) for the duration of the study. The maximum specified dose of enalapril was 40 mg/day. For participants unable to swallow tablets, or for those who weighed <25 kg, enalapril suspension (1 mg/mL) was prepared. The starting dose of drug and any adjustments during the open-label period were at the discretion of the investigator."
1097458|NCT00568178|E3|Reported Event|Losartan Open-Label Extension|"Please note that the open label participant population was derived exclusively from the original base study population. There was no additional recruitment.~Participants were randomized to either losartan or enalapril, administered in an unblinded fashion (placebo was not used) for the duration of the study. The maximum dose of losartan was 50 mg/day (if the participant weighed <50 kg) or 100 mg/day (if the participant weighed ≥50 kg) Losartan 25-mg and 50-mg tablets were available for participants able to swallow tablets, and losartan suspension (2.5 mg/ml) was prepared for participants unable to swallow tablets, or for those who weighed <25 kg."
1097459|NCT00568178|E2|Reported Event|Amlodipine/Placebo: Double-Blind Base Study|"Amlodipine/Placebo group includes the following: Normotensive patients randomized to losartan placebo. Hypertensive patients randomized to amlodipine and losartan placebo.~Losartan placebo dispensed as tablets or suspension depending on patient weight and ability to swallow tablets. Amlodipine dispensed as suspension for duration of study. Losartan placebo suspension dosing: 0.7 mg/kg/day titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks.~Amlodipine suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan placebo tablet dosing: 25 mg/day orally titrated to 50 mg/day (patients <50 kg) OR 50 mg/day orally titrated to 100 mg/day (patients ≥50 kg) for 12 weeks."
1097460|NCT00568178|E1|Reported Event|Losartan: Double-Blind Base Study|"Four arms combined to 2 groups (losartan & amlodipine/placebo) for reporting and compared those who took losartan to those who did not (i.e., participants took amlodipine and/or placebo).~Losartan group: Normotensives were randomized to losartan and Hypertensives were randomized to losartan & amlodipine placebo.~Losartan dispensed as tablets or suspension depending on patient weight and ability to swallow tablets. Amlodipine placebo dispensed as suspension for duration of study.~Losartan suspension dosing: 0.7 milligram/kilograms/day (mg/kg/day) titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks. Amlodipine placebo suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks."
1097461|NCT00568087|B3|Baseline|Total|Total of all reporting groups
1097462|NCT00568087|B2|Baseline|Placebo|Identical placebo daily for 8 weeks
1097463|NCT00568087|B1|Baseline|N-acetylcysteine|N-acetylcysteine daily for 8 weeks
1097464|NCT00568087|P2|Participant Flow|Placebo|Identical placebo daily for 8 weeks
1097465|NCT00568087|P1|Participant Flow|N-acetylcysteine|N-acetylcysteine daily for 8 weeks
1097466|NCT00568087|O2|Outcome|Placebo|Identical placebo daily for 8 weeks
1097467|NCT00568087|O1|Outcome|N-acetylcysteine|N-acetylcysteine daily for 8 weeks
1097468|NCT00568087|O2|Outcome|Placebo|Identical placebo daily for 8 weeks
1097469|NCT00568087|O1|Outcome|N-acetylcysteine|N-acetylcysteine daily for 8 weeks
1097470|NCT00568087|O2|Outcome|Placebo|Identical placebo daily for 8 weeks
1097471|NCT00568087|O1|Outcome|N-acetylcysteine|N-acetylcysteine daily for 8 weeks
1097475|NCT00568061|B2|Baseline|Nitrogen Gas|Nitrogen Gas (Placebo) administered at 80ppm
1097476|NCT00568061|B1|Baseline|Inhaled Nitric Oxide|Inhaled Nitric Oxide administered at 80ppm
1097477|NCT00568061|P2|Participant Flow|Nitrogen Gas|Nitrogen Gas (Placebo) administered at 80ppm
1097478|NCT00568061|P1|Participant Flow|Inhaled Nitric Oxide|Inhaled Nitric Oxide administered at 80ppm
1097479|NCT00568061|O2|Outcome|Nitrogen Gas|Nitrogen Gas (Placebo) administered at 80ppm
1097480|NCT00568061|O1|Outcome|Inhaled Nitric Oxide|Inhaled Nitric Oxide administered at 80ppm
1097481|NCT00568061|E2|Reported Event|Nitrogen Gas|Nitrogen Gas (Placebo) administered at 80ppm
1097482|NCT00568061|E1|Reported Event|Inhaled Nitric Oxide|Inhaled Nitric Oxide administered at 80ppm
1097483|NCT00568022|B4|Baseline|Total|Total of all reporting groups
1097484|NCT00568022|B3|Baseline|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
1097485|NCT00568022|B2|Baseline|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
1097610|NCT00567840|O2|Outcome|PA-824 600 mg|PA-824: 600 mg per day for 14 consecutive days
1097487|NCT00568022|P3|Participant Flow|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|After receiving Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day, the dose was escalated such that participants received Ixabepilone 40 mg/m^2 administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
1097488|NCT00568022|P2|Participant Flow|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|After receiving Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day, the dose was escalated such that participants received Ixabepilone 40 mg/m^2 administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
1097489|NCT00568022|P1|Participant Flow|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
1097490|NCT00568022|O1|Outcome|All Participants With Measurable Disease and Tumor Response|The evaluable participant population consisted of participants who met the minimum safety evaluation requirements of the study: participant received ≥ 1 dose of ixabepilone and/or capecitabine in Cycle 1, completed adequate safety evaluations, and was observed for ≥ 21 days following the first dose or the participant experienced DLT.
1097491|NCT00568022|O3|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
1097492|NCT00568022|O2|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
1097493|NCT00568022|O1|Outcome|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
1097494|NCT00568022|O3|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
1097495|NCT00568022|O2|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
1097496|NCT00568022|O1|Outcome|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
1097497|NCT00568022|O3|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
1097498|NCT00568022|O2|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
1097499|NCT00568022|O1|Outcome|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
1097500|NCT00568022|O3|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
1097501|NCT00568022|O2|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
1097502|NCT00568022|O1|Outcome|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
1097503|NCT00568022|O3|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
1097504|NCT00568022|O2|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
1097505|NCT00568022|O1|Outcome|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
1097506|NCT00568022|O3|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
1097507|NCT00568022|O2|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
1097508|NCT00568022|O1|Outcome|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
1097509|NCT00568022|O3|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
1102461|NCT00556543|O1|Outcome|All Study Subjects|
1097511|NCT00568022|O1|Outcome|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
1097512|NCT00568022|O3|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
1097513|NCT00568022|O2|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
1097514|NCT00568022|O1|Outcome|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
1097515|NCT00568022|E3|Reported Event|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
1097516|NCT00568022|E2|Reported Event|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
1097517|NCT00568022|E1|Reported Event|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each treatment cycle.
1097518|NCT00567996|B4|Baseline|Total|Total of all reporting groups
1097519|NCT00567996|B3|Baseline|Placebo|Placebo to indacaterol inhaled via SDDPI. Placebo to salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1097520|NCT00567996|B2|Baseline|Salmeterol 50 μg|Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1097521|NCT00567996|B1|Baseline|Indacaterol 150 μg|Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1097522|NCT00567996|P3|Participant Flow|Placebo|Placebo to indacaterol inhaled via SDDPI. Placebo to salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1097523|NCT00567996|P2|Participant Flow|Salmeterol 50 μg|Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1097524|NCT00567996|P1|Participant Flow|Indacaterol 150 μg|Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1097583|NCT00567879|E3|Reported Event|Escalation/Expansion: i.v. Arm -20mg/m^2|20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
1097584|NCT00567879|E2|Reported Event|Escalation: i.v. Arm - 15mg/m^2|15 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
1097525|NCT00567996|O3|Outcome|Placebo|Placebo to indacaterol inhaled via SDDPI. Placebo to salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1097526|NCT00567996|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1097527|NCT00567996|O1|Outcome|Indacaterol 150 μg|Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1097528|NCT00567996|O3|Outcome|Placebo|Placebo to indacaterol inhaled via SDDPI. Placebo to salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1097547|NCT00567892|O1|Outcome|2-Weeks Active rTMSTreatment|Daily rTMS for about 1 hour with active device settings (stimulation intensity at 110% of motor threshold)
1097548|NCT00567892|O4|Outcome|4-weeks rTMS Sham Treatment|Daily sham-rTMS for about 1 hour with sham device settings for 4 weeks.
1097529|NCT00567996|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1097530|NCT00567996|O1|Outcome|Indacaterol 150 μg|Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1097531|NCT00567996|O3|Outcome|Placebo|Placebo to indacaterol inhaled via SDDPI. Placebo to salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1097532|NCT00567996|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1097533|NCT00567996|O1|Outcome|Indacaterol 150 μg|Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1097534|NCT00567996|E3|Reported Event|Placebo|Placebo to Indacaterol once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1097535|NCT00567996|E2|Reported Event|Salmeterol 50 μg|Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1097536|NCT00567996|E1|Reported Event|Indacaterol 150 μg|Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
1097537|NCT00567892|B3|Baseline|Total|Total of all reporting groups
1097538|NCT00567892|B2|Baseline|4 Week Treatment|Treatment (either active rTMS or sham)for 4 weeks followed by 2 week wash-out then treatment (opposite of first assignment)for 4 weeks
1097539|NCT00567892|B1|Baseline|2 Week Treatment|Treatment (either active rTMS or sham)for 2 weeks followed by 2 week wash-out then treatment (opposite of first assignment)for 2 weeks
1097540|NCT00567892|P4|Participant Flow|Sham Then Active rTMS Treatment (4 Weeks)|Sham treatment for 4 weeks followed by 2 weeks wash-out and then 4 weeks Active rTMS Treatment. Subjects who do not return to within 20 points of Baseline THI at the end of 2 weeks washout will have washout extended up to 2 additional 2-week washout-periods.At the end of 6 weeks total washout, if the subject's THI remains greater than 20 points difference from bsseline THI subject will be considered to have completed the study and will not complete the second cross study arm. Subject will go staight to end of study visit.
1097541|NCT00567892|P3|Participant Flow|Active Then Sham rTMS Treatment (4 Weeks)|Active rTMS Treatment for 4 weeks followed by 2 weeks wash-out and then 4 weeks sham.Subjects who do not return to within 20 points of Baseline THI at the end of 2 weeks washout will have washout extended up to 2 additional 2-week washout-periods.At the end of 6 weeks total washout, if the subject's THI remains greater than 20 points difference from bsseline THI subject will be considered to have completed the study and will not complete the second cross study arm. Subject will go staight to end of study visit.One subject had a drop of THI larger than 20 points from baseline after first arm of treatment and did not get the second arm.
1097585|NCT00567879|E1|Reported Event|Escalation: i.v. Arm - 10mg/m^2|10 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
1097542|NCT00567892|P2|Participant Flow|Sham Then Active rTMS Treatment (2 Weeks)|Sham treatment for 2 weeks followed by 2 weeks wash-out and then 2 weeks Active rTMS Treatment.Subjects who do not return to within 20 points of Baseline THI at the end of 2 weeks washout will have washout extended up to 2 additional 2-week washout-periods.At the end of 6 weeks total washout, if the subject's THI remains greater than 20 points difference from bsseline THI subject will be considered to have completed the study and will not complete the second cross study arm. Subject will go staight to end of study visit.
1097543|NCT00567892|P1|Participant Flow|Active Then Sham rTMS Treatment (2 Weeks)|Active rTMS Treatment for 2 weeks followed by 2 weeks wash-out and then 2 weeks sham. Subjects who do not return to within 20 points of Baseline THI at the end of 2 weeks washout will have washout extended up to 2 additional 2-week washout-periods.At the end of 6 weeks total washout, if the subject's THI remains greater than 20 points difference from bsseline THI subject will be considered to have completed the study and will not complete the second cross study arm. Subject will go staight to end of study visit.
1097544|NCT00567892|O4|Outcome|4-Weeks Sham rTMS Treatment|Daily sham-rTMS for about 1 hour with sham device settings for 4 weeks.
1097545|NCT00567892|O3|Outcome|4-Weeks Active rTMSTreatment|Daily rTMS for about 1 hour with active device settings (stimulation intensity at 110% of motor threshold), for 4 weeks.
1097546|NCT00567892|O2|Outcome|2-Weeks Sham rTMS Treatment|Daily sham-rTMS for about 1 hour with sham device settings for 2 weeks).
1097604|NCT00567840|O3|Outcome|PA-824 1000 mg|PA-824: 1000 mg per day for 14 consecutive days
1097549|NCT00567892|O3|Outcome|4-weeks rTMS Active Treatment|Daily rTMS for about 1 hour with active device settings (stimulation intensity at 110% of motor threshold), for 4 weeks.
1097550|NCT00567892|O2|Outcome|2-Weeks Sham rTMS Treatment|Daily sham-rTMS for about 1 hour with sham device settings for 2 weeks.
1097551|NCT00567892|O1|Outcome|2-weeks rTMS Active Treatment|Daily rTMS for about 1 hour with active device settings (stimulation intensity at 110% of motor threshold), for 2 weeks.
1097552|NCT00567892|E2|Reported Event|Four Week Treatment|Treatment (either active rTMS or sham)for 4 weeks followed by 2 week wash-out then treatment (opposite of first assignment)for 4 weeks
1097553|NCT00567892|E1|Reported Event|2 Weeks Treatment|Treatment (either active rTMS or sham) for two weeks followed by 2 weeks wash-out then treatment (opposite of first assignment)for two weeks
1097554|NCT00567879|B7|Baseline|Total|Total of all reporting groups
1097555|NCT00567879|B6|Baseline|Oral Arm - Schedule B 20mg|20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
1097556|NCT00567879|B5|Baseline|Oral Arm - Schedule B 15mg|15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
1097557|NCT00567879|B4|Baseline|Oral Arm - Schedule A 20mg|20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
1097558|NCT00567879|B3|Baseline|Escalation/Expansion: i.v. Arm -20mg/m^2|20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
1097559|NCT00567879|B2|Baseline|Escalation: i.v. Arm - 15mg/m^2|15 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
1097560|NCT00567879|B1|Baseline|Escalation: i.v. Arm - 10mg/m^2|10 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
1097561|NCT00567879|P6|Participant Flow|Oral Arm - Schedule B 20mg|20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
1097562|NCT00567879|P5|Participant Flow|Oral Arm - Schedule B 15 mg|15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
1097563|NCT00567879|P4|Participant Flow|Oral Arm - Schedule A 20mg|20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
1097564|NCT00567879|P3|Participant Flow|Escalation/Expansion: i.v. Arm -20mg/m^2|20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
1097565|NCT00567879|P2|Participant Flow|Escalation: i.v. Arm - 15mg/m^2|15 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
1097566|NCT00567879|P1|Participant Flow|Escalation: i.v. Arm - 10mg/m^2|10 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
1097567|NCT00567879|O6|Outcome|Oral Arm - Schedule B 20mg|20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
1097568|NCT00567879|O5|Outcome|Oral Arm - Schedule B 15 mg|15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
1097569|NCT00567879|O4|Outcome|Oral Arm - Schedule A 20mg|20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
1097570|NCT00567879|O3|Outcome|Escalation/Expansion: i.v. Arm -20mg/m^2|20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
1097571|NCT00567879|O2|Outcome|Escalation: i.v. Arm - 15mg/m^2|15 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
1097572|NCT00567879|O1|Outcome|Escalation: i.v. Arm - 10mg/m^2|10 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
1097573|NCT00567879|O7|Outcome|Oral Arm - Schedule B 20mg|20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
1097574|NCT00567879|O6|Outcome|Oral Arm - Schedule B 15 mg|15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
1097575|NCT00567879|O5|Outcome|Oral Arm - Schedule A 20mg|20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
1097576|NCT00567879|O4|Outcome|Expansion: i.v. Arm -20mg/m^2|20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
1097577|NCT00567879|O3|Outcome|Escalation/Expansion: i.v. Arm -20mg/m^2|20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
1097578|NCT00567879|O2|Outcome|Escalation: i.v. Arm - 15mg/m^2|15 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
1097579|NCT00567879|O1|Outcome|Escalation: i.v. Arm - 10mg/m^2|10 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
1097580|NCT00567879|E6|Reported Event|Oral Arm - Schedule B 20mg|20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
1097581|NCT00567879|E5|Reported Event|Oral Arm - Schedule B 15 mg|15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
1097582|NCT00567879|E4|Reported Event|Oral Arm - Schedule A 20mg|20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
1097587|NCT00567840|B5|Baseline|Rifafour|Rifafour e-275 on Days 1 to 14, dosed by weight
1097588|NCT00567840|B4|Baseline|PA-824 1200 mg|PA-824: 1200 mg per day for 14 consecutive days
1097589|NCT00567840|B3|Baseline|PA-824 1000 mg|PA-824: 1000 mg per day for 14 consecutive days
1097590|NCT00567840|B2|Baseline|PA-824 600 mg|PA-824: 600 mg per day for 14 consecutive days
1097591|NCT00567840|B1|Baseline|PA-824 200 mg|PA-824: 200 mg per day for 14 consecutive days
1097592|NCT00567840|P5|Participant Flow|Rifafour|Rifafour e-275 on Days 1 to 14, dosed by weight
1097593|NCT00567840|P4|Participant Flow|PA-824 1200 mg|PA-824: 1200 mg per day for 14 consecutive days
1097594|NCT00567840|P3|Participant Flow|PA-824 1000 mg|PA-824: 1000 mg per day for 14 consecutive days
1097595|NCT00567840|P2|Participant Flow|PA-824 600 mg|PA-824: 600 mg per day for 14 consecutive days
1097596|NCT00567840|P1|Participant Flow|PA-824 200 mg|PA-824: 200 mg per day for 14 consecutive days
1097597|NCT00567840|O5|Outcome|Rifafour|Rifafour e-275 on Days 1 to 14, dosed by weight
1097598|NCT00567840|O4|Outcome|PA-824 1200 mg|PA-824: 1200 mg per day for 14 consecutive days
1097599|NCT00567840|O3|Outcome|PA-824 1000 mg|PA-824: 1000 mg per day for 14 consecutive days
1097600|NCT00567840|O2|Outcome|PA-824 600 mg|PA-824: 600 mg per day for 14 consecutive days
1097601|NCT00567840|O1|Outcome|PA-824 200 mg|PA-824: 200 mg per day for 14 consecutive days
1097602|NCT00567840|O5|Outcome|Rifafour|Rifafour e-275 on Days 1 to 14, dosed by weight
1097603|NCT00567840|O4|Outcome|PA-824 1200 mg|PA-824: 1200 mg per day for 14 consecutive days
1097611|NCT00567840|O1|Outcome|PA-824 200 mg|PA-824: 200 mg per day for 14 consecutive days
1097612|NCT00567840|O5|Outcome|Rifafour|Rifafour e-275 on Days 1 to 14, dosed by weight
1097613|NCT00567840|O4|Outcome|PA-824 1200 mg|PA-824: 1200 mg per day for 14 consecutive days
1097614|NCT00567840|O3|Outcome|PA-824 1000 mg|PA-824: 1000 mg per day for 14 consecutive days
1097615|NCT00567840|O2|Outcome|PA-824 600 mg|PA-824: 600 mg per day for 14 consecutive days
1097616|NCT00567840|O1|Outcome|PA-824 200 mg|PA-824: 200 mg per day for 14 consecutive days
1097617|NCT00567840|O5|Outcome|Rifafour|Rifafour e-275 on Days 1 to 14, dosed by weight
1097618|NCT00567840|O4|Outcome|PA-824 1200 mg|PA-824: 1200 mg per day for 14 consecutive days
1097619|NCT00567840|O3|Outcome|PA-824 1000 mg|PA-824: 1000 mg per day for 14 consecutive days
1097620|NCT00567840|O2|Outcome|PA-824 600 mg|PA-824: 600 mg per day for 14 consecutive days
1097621|NCT00567840|O1|Outcome|PA-824 200 mg|PA-824: 200 mg per day for 14 consecutive days
1097622|NCT00567840|O5|Outcome|Rifafour|Rifafour e-275 on Days 1 to 14, dosed by weight
1097623|NCT00567840|O4|Outcome|PA-824 1200 mg|PA-824: 1200 mg per day for 14 consecutive days
1097624|NCT00567840|O3|Outcome|PA-824 1000 mg|PA-824: 1000 mg per day for 14 consecutive days
1097625|NCT00567840|O2|Outcome|PA-824 600 mg|PA-824: 600 mg per day for 14 consecutive days
1097626|NCT00567840|O1|Outcome|PA-824 200 mg|PA-824: 200 mg per day for 14 consecutive days
1097627|NCT00567840|E5|Reported Event|Rifafour|Rifafour e-275 on Days 1 to 14, dosed by weight
1097628|NCT00567840|E4|Reported Event|PA-824 1200 mg|PA-824: 1200 mg per day for 14 consecutive days
1097629|NCT00567840|E3|Reported Event|PA-824 1000 mg|PA-824: 1000 mg per day for 14 consecutive days
1097630|NCT00567840|E2|Reported Event|PA-824 600 mg|PA-824: 600 mg per day for 14 consecutive days
1097631|NCT00567840|E1|Reported Event|PA-824 200 mg|PA-824: 200 mg per day for 14 consecutive days
1097632|NCT00566579|B3|Baseline|Total|Total of all reporting groups
1097633|NCT00566579|B2|Baseline|Observation|Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
1097634|NCT00566579|B1|Baseline|Cryotherapy|Double-freezing cryotherapy was done within one month after the primary hpv testing was positive. Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
1097635|NCT00566579|P2|Participant Flow|Observation|Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
1097636|NCT00566579|P1|Participant Flow|Cryotherapy|Double-freezing cryotherapy was done within one month after the primary hpv testing was positive. Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
1097637|NCT00566579|O2|Outcome|Observation|Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
1097638|NCT00566579|O1|Outcome|Cryotherapy|Double-freezing cryotherapy was done within one month after the primary hpv testing was positive. Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
1097639|NCT00566579|E2|Reported Event|Observation|Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
1097640|NCT00566579|E1|Reported Event|Cryotherapy|Double-freezing cryotherapy was done within one month after the primary hpv testing was positive. Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
1097641|NCT00566501|B3|Baseline|Total|Total of all reporting groups
1097642|NCT00566501|B2|Baseline|10 mg IR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
1097643|NCT00566501|B1|Baseline|23 mg SR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
1097644|NCT00566501|P2|Participant Flow|10 mg IR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
1097645|NCT00566501|P1|Participant Flow|23 mg SR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
1097646|NCT00566501|O2|Outcome|10 mg IR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
1097647|NCT00566501|O1|Outcome|23 mg SR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
1097648|NCT00566501|E2|Reported Event|10 mg IR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
1097649|NCT00566501|E1|Reported Event|23 mg SR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
1097650|NCT00566462|B1|Baseline|Perampanel|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of Perampanel for 14 days, then two 2-mg tablets/day (4-mg/day)PO of Perampanel for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
1097651|NCT00566462|P1|Participant Flow|Perampanel|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of Perampanel for 14 days, then two 2-mg tablets/day (4-mg/day)PO of Perampanel for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
1097652|NCT00566462|O1|Outcome|Perampanel|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of Perampanel for 14 days, then two 2-mg tablets/day (4-mg/day)PO of Perampanel for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
1103720|NCT00553787|E1|Reported Event|Placebo|
1097653|NCT00566462|O1|Outcome|Perampanel|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of Perampanel for 14 days, then two 2-mg tablets/day (4-mg/day)PO of Perampanel for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
1097654|NCT00566462|E1|Reported Event|Perampanel|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of Perampanel for 14 days, then two 2-mg tablets/day (4-mg/day)PO of Perampanel for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
1097655|NCT00567593|B1|Baseline|Rosaglitazone|Rosiglitazone: 8mg tablet once a day for 14 days
1097656|NCT00567593|P1|Participant Flow|Rosiglitazone|Rosiglitazone: 8mg tablet once a day for 14 days
1097657|NCT00567593|O1|Outcome|Rosiglitazone|Rosiglitazone: 8mg tablet once a day for 14 days
1097658|NCT00567593|E1|Reported Event|Rosiglitazone|Rosiglitazone: 8mg tablet once a day for 14 days
1097659|NCT00567541|B3|Baseline|Total|Total of all reporting groups
1097660|NCT00567541|B2|Baseline|Sham BBPM Stimulation|Sham Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, the device will be reprogrammed to deliver therapeutic stimulation.
1097661|NCT00567541|B1|Baseline|Active BBPM Stimulation|Active Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver therapeutic amplitude electrical stimulation.
1097662|NCT00567541|P2|Participant Flow|Sham BBPM Stimulation|"The Battery Powered Microneuromodulator(BBPM) will be programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, they will be reprogrammed to receive therapeutic stimulation.~Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, the device will be reprogrammed to deliver therapeutic stimulation."
1097663|NCT00567541|P1|Participant Flow|Active BBPM Stimulation|"The Battery Powered Microneuromodulator (BBPM) is programmed to deliver set therapeutic stimulation parameters for the first 12 weeks of the study.~Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) will be programmed for the first 12 weeks of the study to deliver therapeutic amplitude electrical stimulation. therapeutic treatment."
1097664|NCT00567541|O2|Outcome|Sham BBPM Stimulation|The Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, the device is reprogrammed to deliver therapeutic stimulation.
1097665|NCT00567541|O1|Outcome|Active BBPM Stimulation|The.Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver therapeutic amplitude electrical stimulation.
1097666|NCT00567541|E2|Reported Event|Sham BBPM Stimulation|The Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, the device is reprogrammed to deliver therapeutic stimulation.
1097667|NCT00567541|E1|Reported Event|Active BBPM Stimulation|The.Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver therapeutic amplitude electrical stimulation.
1097668|NCT00567502|B5|Baseline|Total|Total of all reporting groups
1097786|NCT00567268|O4|Outcome|Three Concomitant Antiepileptic Drugs|Participants taking three concomitant antiepileptic drugs at baseline
1097669|NCT00567502|B4|Baseline|No Essential Thrombocythemia (ET) Therapy|Participants who were not receiving any cytoreductive treatment for at least 28 consecutive days at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion.
1097670|NCT00567502|B3|Baseline|Other (Cytoreductives)|Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
1097671|NCT00567502|B2|Baseline|XAGRID+Other (Cytoreductives)|Participants who received XAGRID along with Other cytoreductives drugs at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
1097672|NCT00567502|B1|Baseline|XAGRID Only|Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant Summary of Product Characteristics (SmPC) at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion.
1097673|NCT00567502|P4|Participant Flow|No Essential Thrombocythemia (ET) Therapy|Participants who were not receiving any cytoreductive treatment for at least 28 consecutive days at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator’s discretion.
1097674|NCT00567502|P3|Participant Flow|Other (Cytoreductives)|Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
1098814|NCT00564486|O1|Outcome|IV Placebo|IV Placebo 100 ml and IV placebo 65 ml groups combined
1097675|NCT00567502|P2|Participant Flow|XAGRID+Other (Cytoreductives)|Participants who received XAGRID+Other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
1097676|NCT00567502|P1|Participant Flow|XAGRID Only|Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant Summary of Product Characteristics (SmPC) at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion
1097677|NCT00567502|O2|Outcome|Other (Cytoreductives)|Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years. Other Cytoreductives included Hydroxyurea, Interferonalpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
1097678|NCT00567502|O1|Outcome|XAGRID|Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
1097679|NCT00567502|O9|Outcome|Other|Participants who received other therapies at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
1097680|NCT00567502|O8|Outcome|Other (Cytoreductives)-Thromboreductin|Participants who received other (Cytoreductives)-Thromboreductin at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
1097681|NCT00567502|O7|Outcome|Other (Cytoreductives)-Sodium Phosphate P32|Participants who received other (Cytoreductives)-Sodium Phosphate P32 at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
1097682|NCT00567502|O6|Outcome|Other (Cytoreductives)-Pipobroman|Participants who received other (Cytoreductives)-Pipobroman at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
1097683|NCT00567502|O5|Outcome|Other (Cytoreductives)-Busulphan|Participants who received other (Cytoreductives)-Busulphan at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
1097684|NCT00567502|O4|Outcome|Other (Cytoreductives)-Pegylated Interferon|Participants who received other (Cytoreductives)-Pegylated Interferon at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
1097685|NCT00567502|O3|Outcome|Other (Cytoreductives)-Interferon Alpha|Participants who received other (Cytoreductives)-Interferon Alpha at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
1097686|NCT00567502|O2|Outcome|Other (Cytoreductives)-Hydroxyurea|Participants who received other (Cytoreductives)-Hydroxyurea at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
1097687|NCT00567502|O1|Outcome|XAGRID Only|Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
1097688|NCT00567502|O9|Outcome|Other|Participants who received other therapies at a dose and mode of administration managed as per investigator’s discretion and the relevant SmPC, was observed for 5 years.
1097689|NCT00567502|O8|Outcome|Other (Cytoreductives)-Thromboreductin|Participants who received other (Cytoreductives)-Thromboreductin at a dose and mode of administration managed as per investigator’s discretion and the relevant SmPC, was observed for 5 years.
1097690|NCT00567502|O7|Outcome|Other (Cytoreductives)-Sodium Phosphate P32|Participants who received other (Cytoreductives)-Sodium Phosphate P32 at a dose and mode of administration managed as per investigator’s discretion and the relevant SmPC, was observed for 5 years.
1097691|NCT00567502|O6|Outcome|Other (Cytoreductives)-Pipobroman|Participants who received other (Cytoreductives)-Pipobroman at a dose and mode of administration managed as per investigator’s discretion and the relevant SmPC, was observed for 5 years.
1097787|NCT00567268|O3|Outcome|Two Concomitant Antiepileptic Drugs|Participants taking two concomitant antiepileptic drugs at baseline
1097692|NCT00567502|O5|Outcome|Other (Cytoreductives)-Busulphan|Participants who received other (Cytoreductives)-Busulphan at a dose and mode of administration managed as per investigator’s discretion and the relevant SmPC, was observed for 5 years.
1097693|NCT00567502|O4|Outcome|Other (Cytoreductives)-Pegylated Interferon|Participants who received other (Cytoreductives)-Pegylated Interferon at a dose and mode of administration managed as per investigator’s discretion and the relevant SmPC, was observed for 5 years.
1097694|NCT00567502|O3|Outcome|Other (Cytoreductives)-Interferon Alpha|Participants who received other (Cytoreductives)-Interferon Alpha at a dose and mode of administration managed as per investigator’s discretion and the relevant SmPC, was observed for 5 years.
1097695|NCT00567502|O2|Outcome|Other (Cytoreductives)-Hydroxyurea|Participants who received other (Cytoreductives)-Hydroxyurea at a dose and mode of administration managed as per investigator’s discretion and the relevant SmPC, was observed for 5 years.
1097696|NCT00567502|O1|Outcome|XAGRID Taken|"Participants who received XAGRID from Xagrid only or Xagrid+other (cytoreductives) arm groups at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study for a 5 year observation period."
1097697|NCT00567502|O4|Outcome|No Essential Thrombocythemia (ET) Therapy|Participants who were not receiving any cytoreductive treatment for at least 28 consecutive days at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion.
1097698|NCT00567502|O3|Outcome|Other (Cytoreductives)|Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period.Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
1097877|NCT00567190|O2|Outcome|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
1098700|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
1097699|NCT00567502|O2|Outcome|XAGRID+Other (Cytoreductives)|Participants who received XAGRID+Other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
1097700|NCT00567502|O1|Outcome|XAGRID Only|Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period.
1097701|NCT00567502|O4|Outcome|No Essential Thrombocythemia (ET) Therapy|Participants who were not receiving any cytoreductive treatment for at least 28 consecutive days at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion.
1097702|NCT00567502|O3|Outcome|Other (Cytoreductives)|Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
1097703|NCT00567502|O2|Outcome|XAGRID+Other (Cytoreductives)|Participants who received XAGRID+Other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
1097704|NCT00567502|O1|Outcome|XAGRID Only|Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period.
1097705|NCT00567502|O3|Outcome|Other (Cytoreductives)|Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
1097706|NCT00567502|O2|Outcome|XAGRID+Other (Cytoreductives)|Participants who received XAGRID+Other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
1097707|NCT00567502|O1|Outcome|XAGRID Only|Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period.
1097708|NCT00567502|E2|Reported Event|Other (Cytoreductives)|"Participants who received other (cytoreductives) from  other (cytoreductives or Xagrid+other (cytoreductives) arm groups (for serious adverse events) at a dose and mode of administration managed as per investigator's discretion and the relevant Summary of Product Characteristics (SmPC) at the time of registering into the study or after switching from another treatment (other adverse events) any time during the 5 year observation period. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32."
1097709|NCT00567502|E1|Reported Event|XAGRID|"Participants who received XAGRID from Xagrid only or Xagrid+other (cytoreductives) arm groups (for serious adverse events) at a dose and mode of administration managed as per investigator's discretion and the relevant Summary of Product Characteristics (SmPC) at the time of registering into the study or after switching from another treatment (other adverse events) any time during the 5 year observation period."
1097710|NCT00567476|B3|Baseline|Total|Total of all reporting groups
1097711|NCT00567476|B2|Baseline|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
1097788|NCT00567268|O2|Outcome|One Concomitant Antiepileptic Drug|Participants taking one concomitant antiepileptic drug at baseline
1097712|NCT00567476|B1|Baseline|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
1097713|NCT00567476|P2|Participant Flow|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
1097714|NCT00567476|P1|Participant Flow|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
1097715|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
1097716|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
1097717|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
1097718|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
1097719|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
1097720|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
1097721|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
1097722|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
1097723|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
1097724|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
1097747|NCT00567307|B2|Baseline|Standard Practice Group (Arm B)|"Standard Practice~Standard Practice: Arm B received management of their CVD risk according to the usual care given to participants in similar conditions"
1097833|NCT00567255|O2|Outcome|Placebo|Placebo
1097725|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
1097726|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
1097727|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
1097728|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
1098701|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
1097729|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
1097730|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
1097731|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
1097732|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
1097733|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
1097734|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
1097735|NCT00567476|E2|Reported Event|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
1097736|NCT00567476|E1|Reported Event|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
1097737|NCT00567320|B3|Baseline|Total|Total of all reporting groups
1097738|NCT00567320|B2|Baseline|Placebo|This is the Placebo condition
1097739|NCT00567320|B1|Baseline|Varenicline|Varenicline 2 mg per day.
1097740|NCT00567320|P2|Participant Flow|Placebo|This is the Placebo condition
1097741|NCT00567320|P1|Participant Flow|Varenicline|Varenicline 2 mg per day.
1097742|NCT00567320|O2|Outcome|Placebo|This is the Placebo condition
1097743|NCT00567320|O1|Outcome|Varenicline|Varenicline 2 mg per day.
1097744|NCT00567320|E2|Reported Event|Placebo|This is the Placebo condition
1097745|NCT00567320|E1|Reported Event|Varenicline|Varenicline 2 mg per day.
1097746|NCT00567307|B3|Baseline|Total|Total of all reporting groups
1097834|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
1097748|NCT00567307|B1|Baseline|The Polypill Group (Arm A)|"The Polypill Group (Arm A) received a Polypill composed of 75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide~Red Heart Pill 2b (Polypill): Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg)"
1097749|NCT00567307|P2|Participant Flow|Standard Practice Group (Arm B)|"Standard Practice~Standard Practice: Arm B received management of their CVD risk according to the usual care given to participants in similar conditions"
1097750|NCT00567307|P1|Participant Flow|The Polypill Group (Arm A)|"The Polypill Group (Arm A) received a Polypill composed of 75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide~Red Heart Pill 2b (Polypill): Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg)"
1097751|NCT00567307|O2|Outcome|Standard Practice Group (Arm B)|"Standard Practice~Standard Practice: Arm B received management of their CVD risk according to the usual care given to participants in similar conditions"
1097752|NCT00567307|O1|Outcome|The Polypill Group (Arm A)|"The Polypill Group (Arm A) received a Polypill composed of 75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide~Red Heart Pill 2b (Polypill): Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg)"
1097753|NCT00567307|E2|Reported Event|Standard Practice Group (Arm B)|"Standard Practice~Standard Practice: Arm B received management of their CVD risk according to the usual care given to participants in similar conditions"
1097878|NCT00567190|O1|Outcome|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
1097754|NCT00567307|E1|Reported Event|The Polypill Group (Arm A)|"The Polypill Group (Arm A) received a Polypill composed of 75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide~Red Heart Pill 2b (Polypill): Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg)"
1097755|NCT00567268|B1|Baseline|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
1097756|NCT00567268|P1|Participant Flow|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
1097757|NCT00567268|O2|Outcome|Absence of Non-Drug Therapy|Participants without non-drug therapy who responded to treatment with gabapentin
1097758|NCT00567268|O1|Outcome|Presence of Non-Drug Therapy|Participants with non-drug therapy who responded to treatment with gabapentin
1097759|NCT00567268|O6|Outcome|Unkown|Participants with unkown baseline creatinine clearance
1097760|NCT00567268|O5|Outcome|CLcr <5 mL/Min|Participants with baseline creatinine clearance <5 mL/min
1097761|NCT00567268|O4|Outcome|CLcr >=5 and <15 mL/Min|Participants with baseline creatinine clearance >=5 and <15 mL/min
1097762|NCT00567268|O3|Outcome|CLcr >=15 and <30 mL/Min|Participants with baseline creatinine clearance >=15 and <30 mL/min
1097763|NCT00567268|O2|Outcome|CLcr >=30 and <60 mL/Min|Participants with baseline creatinine clearance >=30 and <60 mL/min
1097764|NCT00567268|O1|Outcome|CLcr >=60 mL/Min|Participants with baseline creatinine clearance >=60 mL/min
1097765|NCT00567268|O5|Outcome|Four or More Concomitant Antiepileptic Drugs|Participants taking four or more concomitant antiepileptic drugs at baseline
1097766|NCT00567268|O4|Outcome|Three Concomitant Antiepileptic Drugs|Participants taking three concomitant antiepileptic drugs at baseline
1097767|NCT00567268|O3|Outcome|Two Concomitant Antiepileptic Drugs|Participants taking two concomitant antiepileptic drugs at baseline
1097768|NCT00567268|O2|Outcome|One Concomitant Antiepileptic Drug|Participants taking one concomitant antiepileptic drug at baseline
1097769|NCT00567268|O1|Outcome|No Concomitant Antiepileptic Drug|Participants taking no concomitant antiepileptic drug at baseline
1097770|NCT00567268|O3|Outcome|Unknown|Participants with unknown frequency of baseline episodes who responded to the treatment with gabapentin
1097771|NCT00567268|O2|Outcome|>8 Episodes|Participants with baseline episodes of epileptic seizure more than 8 who responded to the treatment with gabapentin
1097772|NCT00567268|O1|Outcome|<=8 Episodes|Participants with baseline episodes of epileptic seizure below 8 who responded to the treatment with gabapentin
1097773|NCT00567268|O3|Outcome|Severe|Participants with severe epilepsy who responded to the treatment with gabapentin
1097774|NCT00567268|O2|Outcome|Moderate|Participants with moderate epilepsy who responded to the treatment with gabapentin
1097775|NCT00567268|O1|Outcome|Mild|Participants with mild epilepsy who responded to the treatment with gabapentin
1097776|NCT00567268|O7|Outcome|Age >=65 Years|Participants >=65 years of age who responded to the treatment with gabapentin
1097777|NCT00567268|O6|Outcome|Age >=55 and <65 Years|Participants >=55 and <65 years of age who responded to the treatment with gabapentin
1097778|NCT00567268|O5|Outcome|Age >=45 and <55 Years|Participants >=45 and <55 years of age who responded to the treatment with gabapentin
1097779|NCT00567268|O4|Outcome|Age >=35 and <45 Years|Participants >=35 and <45 years of age who responded to the treatment with gabapentin
1097780|NCT00567268|O3|Outcome|Age >=25 and <35 Years|Participants >=25 and <35 years of age who responded to the treatment with gabapentin
1097781|NCT00567268|O2|Outcome|Age >=15 and <25 Years|Participants >=15 and <25 years of age who responded to the treatment with gabapentin
1097782|NCT00567268|O1|Outcome|Age <15 Years|Participants <15 years of age who responded to the treatment with gabapentin
1097783|NCT00567268|O2|Outcome|Age >=65 Years|Participants >=65 years of age who responded to the treatment with gabapentin
1097784|NCT00567268|O1|Outcome|Age <65 Years|Participants <65 years of age who responded to the treatment with gabapentin
1097785|NCT00567268|O5|Outcome|Four or More Concomitant Antiepileptic Drugs|Participants taking four or more concomitant antiepileptic drugs at baseline
1097789|NCT00567268|O1|Outcome|No Concomitant Antiepileptic Drug|Participants taking no concomitant antiepileptic drug at baseline
1097790|NCT00567268|O7|Outcome|Age >=65 Years|Participants >=65 years years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
1097791|NCT00567268|O6|Outcome|Age >=55 and <65 Years|Participants >=55 and <65 years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
1097792|NCT00567268|O5|Outcome|Age >=45 and <55 Years|Participants >=45 and <55 years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
1097793|NCT00567268|O4|Outcome|Age >=35 and <45 Years|Participants >=35 and <45 years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
1097794|NCT00567268|O3|Outcome|Age >=25 and <35 Years|Participants >=25 and <35 years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
1097795|NCT00567268|O2|Outcome|Age >=15 and <25 Years|Participants >=15 and <25 years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
1097796|NCT00567268|O1|Outcome|Age <15 Years|Participants <15 years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
1097879|NCT00567190|O2|Outcome|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
1097998|NCT00566995|B1|Baseline|Vandetanib in Participants With Kidney Cancer|300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
1097797|NCT00567268|O1|Outcome|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
1097798|NCT00567268|O1|Outcome|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
1097799|NCT00567268|O1|Outcome|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
1097800|NCT00567268|O1|Outcome|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
1097801|NCT00567268|O1|Outcome|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
1097802|NCT00567268|O1|Outcome|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
1097803|NCT00567268|E1|Reported Event|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
1097804|NCT00567255|B3|Baseline|Total|Total of all reporting groups
1097805|NCT00567255|B2|Baseline|Placebo|Placebo
1097806|NCT00567255|B1|Baseline|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
1097807|NCT00567255|P2|Participant Flow|Placebo|Placebo
1097808|NCT00567255|P1|Participant Flow|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
1097809|NCT00567255|O2|Outcome|Placebo|Placebo
1097810|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
1097811|NCT00567255|O2|Outcome|Placebo|Placebo
1097812|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
1097813|NCT00567255|O2|Outcome|Placebo|Placebo
1097814|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
1097815|NCT00567255|O2|Outcome|Placebo|Placebo
1097816|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
1097817|NCT00567255|O2|Outcome|Placebo|Placebo
1097818|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
1097819|NCT00567255|O2|Outcome|Placebo|Placebo
1097820|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
1097821|NCT00567255|O2|Outcome|Placebo|Placebo
1097822|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
1097823|NCT00567255|O2|Outcome|Placebo|Placebo
1097824|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
1097825|NCT00567255|O2|Outcome|Placebo|Placebo
1097826|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
1097827|NCT00567255|O2|Outcome|Placebo|Placebo
1097828|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
1097829|NCT00567255|O2|Outcome|Placebo|Placebo
1097830|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
1097831|NCT00567255|O2|Outcome|Placebo|Placebo
1097832|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
1097836|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
1097837|NCT00567255|O2|Outcome|Placebo|Placebo
1097838|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
1097839|NCT00567255|O2|Outcome|Placebo|Placebo
1097840|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
1097841|NCT00567255|O2|Outcome|Placebo|Placebo
1097842|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
1097843|NCT00567255|O2|Outcome|Placebo|Placebo
1097844|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
1097845|NCT00567255|O2|Outcome|Placebo|Placebo
1097846|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
1097847|NCT00567255|O2|Outcome|Placebo|Placebo
1097848|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
1097849|NCT00567255|E2|Reported Event|Placebo|Placebo
1097880|NCT00567190|O1|Outcome|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
1098119|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|
1097850|NCT00567255|E1|Reported Event|NB32/48|"Naltrexone SR 32 mg/bupropion SR 360 mg/day or naltrexone SR 48 mg/bupropion SR 360 mg/day~Beginning at Week 28 through Week 44, NB32-treated subjects who failed to achieve or maintain at least 5% body weight loss from baseline were re-randomized (1:1 ratio) to continue NB32 or begin treatment with a higher dose of naltrexone SR - naltrexone SR 48 mg/bupropion SR 360 mg (referred to as NB48) (daily dose of bupropion SR was 360 mg for NB32 and NB48).~NB32/48 group includes all participants in the safety analysis set randomized to NB32 at baseline, regardless of re-randomization status."
1097851|NCT00567242|B3|Baseline|Total|Total of all reporting groups
1097852|NCT00567242|B2|Baseline|Word-finding With no Intention Manipulation|Word-finding trials similar to intention mediated treatment, but without intention manipulation
1097853|NCT00567242|B1|Baseline|Word-finding With Intention Manipulation|Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
1097854|NCT00567242|P2|Participant Flow|Word-finding With no Intention Manipulation|Word-finding trials similar to intention mediated treatment, but without intention manipulation
1097855|NCT00567242|P1|Participant Flow|Word-finding With Intention Manipulation|Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
1097856|NCT00567242|O2|Outcome|Word-finding With no Intention Manipulation|Word-finding trials similar to intention mediated treatment, but without intention manipulation
1097857|NCT00567242|O1|Outcome|Word-finding With Intention Manipulation|Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
1097858|NCT00567242|O2|Outcome|Word-finding With no Intention Manipulation|Word-finding trials similar to intention mediated treatment, but without intention manipulation
1097859|NCT00567242|O1|Outcome|Word-finding With Intention Manipulation|Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
1097860|NCT00567242|O2|Outcome|Word-finding With no Intention Manipulation|Word-finding trials similar to intention mediated treatment, but without intention manipulation
1097861|NCT00567242|O1|Outcome|Word-finding With Intention Manipulation|Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
1097862|NCT00567242|E2|Reported Event|Word-finding With no Intention Manipulation|Word-finding trials similar to intention mediated treatment, but without intention manipulation
1097863|NCT00567242|E1|Reported Event|Word-finding With Intention Manipulation|Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
1097864|NCT00567229|B1|Baseline|Lenalidomide and Rituximab|This study will employ a Simon optimal two-stage design. Patients will receive lenalidomide 25 mg daily for days 1-21 of each 28 day cycle. Rituximab 375 mg/m2 will be given weekly for 4 weeks beginning 1 week after the start of lenalidomide therapy (weeks 2-5), and then once 8 weeks later (week 13). Patients with stable disease or better after 4 cycles (week 16, in the absence of delays for toxicity) will be able to continue on therapy on the same lenalidomide schedule and with rituximab 375 mg/m2 given once every 8 weeks.
1097865|NCT00567229|P1|Participant Flow|Lenalidomide and Rituximab|This study will employ a Simon optimal two-stage design. Patients will receive lenalidomide 25 mg daily for days 1-21 of each 28 day cycle. Rituximab 375 mg/m2 will be given weekly for 4 weeks beginning 1 week after the start of lenalidomide therapy (weeks 2-5), and then once 8 weeks later (week 13). Patients with stable disease or better after 4 cycles (week 16, in the absence of delays for toxicity) will be able to continue on therapy on the same lenalidomide schedule and with rituximab 375 mg/m2 given once every 8 weeks.
1097866|NCT00567229|O1|Outcome|Lenalidomide and Rituximab|This study will employ a Simon optimal two-stage design. Patients will receive lenalidomide 25 mg daily for days 1-21 of each 28 day cycle. Rituximab 375 mg/m2 will be given weekly for 4 weeks beginning 1 week after the start of lenalidomide therapy (weeks 2-5), and then once 8 weeks later (week 13). Patients with stable disease or better after 4 cycles (week 16, in the absence of delays for toxicity) will be able to continue on therapy on the same lenalidomide schedule and with rituximab 375 mg/m2 given once every 8 weeks.
1097867|NCT00567229|E1|Reported Event|Lenalidomide and Rituximab|This study will employ a Simon optimal two-stage design. Patients will receive lenalidomide 25 mg daily for days 1-21 of each 28 day cycle. Rituximab 375 mg/m2 will be given weekly for 4 weeks beginning 1 week after the start of lenalidomide therapy (weeks 2-5), and then once 8 weeks later (week 13). Patients with stable disease or better after 4 cycles (week 16, in the absence of delays for toxicity) will be able to continue on therapy on the same lenalidomide schedule and with rituximab 375 mg/m2 given once every 8 weeks.
1097868|NCT00567190|B3|Baseline|Total|Total of all reporting groups
1097869|NCT00567190|B2|Baseline|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
1097870|NCT00567190|B1|Baseline|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
1097871|NCT00567190|P2|Participant Flow|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
1097872|NCT00567190|P1|Participant Flow|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
1097873|NCT00567190|O2|Outcome|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
1097874|NCT00567190|O1|Outcome|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
1097875|NCT00567190|O2|Outcome|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
1097876|NCT00567190|O1|Outcome|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
1097990|NCT00567008|B2|Baseline|Placebo|Placebo
1097881|NCT00567190|O2|Outcome|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
1097882|NCT00567190|O1|Outcome|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
1097883|NCT00567190|O2|Outcome|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
1097884|NCT00567190|O1|Outcome|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
1097885|NCT00567190|E3|Reported Event|Crossover From Placebo to Pertuzumab|Forty-eight of 406 patients (11.8%) randomized to the placebo treatment group whose disease had not progressed crossed over to an open-label pertuzumab treatment group between July 2012 and November 2012. Patients received pertuzumab administered as an IV loading dose of 840 mg at cycle 1 then 420 mg IV every q3w until investigator-assessed radiographic or clinical evidence of PD, unacceptable toxicity, or withdrawal of consent. Trastuzumab and docetaxel doses continued in accordance with the pre-crossover placebo treatment regimens and according to dosing specifications indicated in the study protocol.
1097886|NCT00567190|E2|Reported Event|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
1097887|NCT00567190|E1|Reported Event|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles. For the 48 patients that crossed over to the pertuzumab treatment group, AEs were analyzed from the day of their first placebo dose (Day 1) through the day just prior to their first pertuzumab dose. Any AEs occurring on, or after, the day of their first dose of pertuzumab were included in the Crossover treatment group analysis.
1097888|NCT00567164|B4|Baseline|Total|Total of all reporting groups
1097889|NCT00567164|B3|Baseline|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
1097890|NCT00567164|B2|Baseline|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1097891|NCT00567164|B1|Baseline|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
1097892|NCT00567164|P3|Participant Flow|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
1097893|NCT00567164|P2|Participant Flow|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1097969|NCT00567112|O2|Outcome|OCT (After Meal)|Participants receiving a single dose of 10 mg MK-0941 OCT administered after consumption of a high-fat meal
1097894|NCT00567164|P1|Participant Flow|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
1097895|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
1097896|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1097991|NCT00567008|B1|Baseline|Varenicline|Varenicline (Chantix)
1097992|NCT00567008|P2|Participant Flow|Placebo|Placebo
1097993|NCT00567008|P1|Participant Flow|Varenicline 2mg/Day|Varenicline (Chantix)
1097897|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
1097898|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1097899|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
1097900|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
1097901|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1097902|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
1097903|NCT00567164|O1|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
1097904|NCT00567164|O2|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
1097905|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1097906|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
1097907|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1097908|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
1097909|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
1097910|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1097911|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
1097912|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
1097913|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1097914|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
1097915|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
1097916|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1097917|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
1097918|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
1097970|NCT00567112|O1|Outcome|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
1097971|NCT00567112|O2|Outcome|OCT (After Meal)|Participants receiving a single dose of 10 mg MK-0941 OCT administered after consumption of a high-fat meal
1097919|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1097920|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
1097921|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
1097922|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1097923|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
1097924|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
1097925|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1097926|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
1097927|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
1097928|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1097929|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
1097930|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
1097972|NCT00567112|O1|Outcome|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
1097973|NCT00567112|O2|Outcome|DFC (Fasted)|Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state
1099764|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
1097931|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1097932|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
1097933|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
1097934|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1097935|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
1097936|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
1097937|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1097938|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
1097939|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
1097940|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1097941|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
1097942|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
1097974|NCT00567112|O1|Outcome|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
1097975|NCT00567112|O2|Outcome|DFC (Fasted)|Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state
1099765|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
1097943|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1097944|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
1097945|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
1097946|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1097947|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
1097948|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
1097949|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1097950|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
1097951|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
1097952|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1097953|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
1097954|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
1097976|NCT00567112|O1|Outcome|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
1097977|NCT00567112|O2|Outcome|OCT (After Meal)|Participants receiving a single dose of 10 mg MK-0941 OCT administered after consumption of a high-fat meal
1097955|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1097956|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
1097957|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
1097958|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1097959|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
1097960|NCT00567164|O2|Outcome|Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2|Pooled FAS of Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) (see first arm) and Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300). Regimen no. 2: Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1097961|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
1097962|NCT00567164|E3|Reported Event|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
1097963|NCT00567164|E2|Reported Event|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1097964|NCT00567164|E1|Reported Event|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
1097965|NCT00567112|B1|Baseline|All Randomized|Includes the 15 participants who were randomized and started the study in Treatment Period 1 (Baseline) and the 3 additional participants who were subsequently randomized and started the study in Treatment Period 2.
1097966|NCT00567112|P3|Participant Flow|Treatment Group BCD|"Period 1: Not Applicable~Period 2: OCT (fasted)~Period 3: OCT (after meal)~Period 4: OCT (before meal)"
1097967|NCT00567112|P2|Participant Flow|Treatment Group BACD|"Period 1: OCT (fasted)~Period 2: DFC (fasted)~Period 3: OCT (after meal)~Period 4: OCT (before meal)"
1097968|NCT00567112|P1|Participant Flow|Treatment Group ABCD|"Period 1: Dry Filled Capsule (DFC) (fasted)~Period 2: Oral Compressed Tablet (OCT) (fasted)~Period 3: OCT (after meal)~Period 4: OCT (before meal)"
1097978|NCT00567112|O1|Outcome|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
1097979|NCT00567112|O2|Outcome|OCT (After Meal)|Participants receiving a single dose of 10 mg MK-0941 OCT administered after consumption of a high-fat meal
1097980|NCT00567112|O1|Outcome|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
1097981|NCT00567112|O2|Outcome|DFC (Fasted)|Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state
1097982|NCT00567112|O1|Outcome|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
1097983|NCT00567112|O2|Outcome|DFC (Fasted)|Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state
1097984|NCT00567112|O1|Outcome|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
1097985|NCT00567112|E4|Reported Event|DFC (Fasted)|Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state
1097986|NCT00567112|E3|Reported Event|OCT (Before Meal)|Participants receiving a single dose of 10 mg MK-0941 OCT administered before consumption of a standard breakfast
1097987|NCT00567112|E2|Reported Event|OCT (After Meal)|Participants receiving a single dose of 10 mg MK-0941 OCT administered after consumption of a high-fat meal
1097988|NCT00567112|E1|Reported Event|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
1097989|NCT00567008|B3|Baseline|Total|Total of all reporting groups
1097999|NCT00566995|P1|Participant Flow|Vandetanib in Participants With Kidney Cancer|300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
1098000|NCT00566995|O1|Outcome|Vandetanib in Participants With Kidney Cancer|300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
1098001|NCT00566995|O1|Outcome|Vandetanib in Participants With Kidney Cancer|300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
1098002|NCT00566995|E1|Reported Event|Vandetanib in Participants With Kidney Cancer|300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
1098003|NCT00566982|B3|Baseline|Total|Total of all reporting groups
1098004|NCT00566982|B2|Baseline|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
1098005|NCT00566982|B1|Baseline|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
1098006|NCT00566982|P2|Participant Flow|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
1098007|NCT00566982|P1|Participant Flow|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
1098008|NCT00566982|O4|Outcome|Subjects on Ospemifene 60 mg/Day (Week 52)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
1098009|NCT00566982|O3|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
1098010|NCT00566982|O2|Outcome|Subjects on Placebo (Week 52)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
1098011|NCT00566982|O1|Outcome|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
1098012|NCT00566982|O2|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
1098013|NCT00566982|O1|Outcome|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
1098014|NCT00566982|O2|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
1098015|NCT00566982|O1|Outcome|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
1098016|NCT00566982|O2|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
1098017|NCT00566982|O1|Outcome|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
1098018|NCT00566982|O2|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
1098019|NCT00566982|O1|Outcome|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
1098020|NCT00566982|O2|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
1098021|NCT00566982|O1|Outcome|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
1098022|NCT00566982|O2|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
1098023|NCT00566982|O1|Outcome|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
1098024|NCT00566982|O2|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
1098025|NCT00566982|O1|Outcome|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
1098026|NCT00566982|E2|Reported Event|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
1098027|NCT00566982|E1|Reported Event|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
1098028|NCT00566969|B4|Baseline|Total|Total of all reporting groups
1098029|NCT00566969|B3|Baseline|Carvedilol 50 mg|"To be compared to placebo and Carvedilol 25 mg~Carvedilol: subjects randomized to placebo, carvedilol 25mg or 50mg"
1098030|NCT00566969|B2|Baseline|Carvedilol 25 mg|"To be compared to placebo and Carvedilol 50 mg~carvedilol: subjects randomized to placebo, carvedilol 25mg or 50mg"
1098031|NCT00566969|B1|Baseline|Sugar Pill|"To be compared to active drug~sugar pill: Subjects randomized to placebo, carvedilol 25mg or 50mg"
1098032|NCT00566969|P3|Participant Flow|Carvedilol 50 mg|"To be compared to sugar pill~carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight."
1098033|NCT00566969|P2|Participant Flow|Carvedilol 25 mg|"To be compared to sugar pill~carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight."
1098034|NCT00566969|P1|Participant Flow|Sugar Pill|"To be compared to active drug~sugar pill: randomly given 25mg or 50mg of a sugar pill or the active comparator"
1098035|NCT00566969|O3|Outcome|Carvedilol 50 mg|"To be compared to sugar pill~carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight."
1098036|NCT00566969|O2|Outcome|Carvedilol 25 mg|"To be compared to sugar pill~carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight."
1098037|NCT00566969|O1|Outcome|Sugar Pill|"To be compared to active drug~sugar pill: randomly given 25mg or 50mg of a sugar pill or the active comparator"
1098038|NCT00566969|E3|Reported Event|Carvedilol 50 mg|"To be compared to sugar pill~carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight."
1098039|NCT00566969|E2|Reported Event|Carvedilol 25 mg|"To be compared to sugar pill~carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight."
1098040|NCT00566969|E1|Reported Event|Sugar Pill|"To be compared to active drug~sugar pill: randomly given 25mg or 50mg of a sugar pill or the active comparator"
1098041|NCT00566943|B3|Baseline|Total|Total of all reporting groups
1098042|NCT00566943|B2|Baseline|PSD Veritas|PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis. Linear and circular refer to the shapes of the Veritas.
1098043|NCT00566943|B1|Baseline|Control|control arm where no buttress is used on stomach or GJ anastomosis staple lines.
1104217|NCT00552669|B3|Baseline|Total|Total of all reporting groups
1098044|NCT00566943|P2|Participant Flow|PSD Veritas|PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis. Linear and circular refer to the shapes of the Veritas.
1098045|NCT00566943|P1|Participant Flow|Control|control arm where no buttress is used on stomach or GJ anastomosis staple lines.
1098046|NCT00566943|O2|Outcome|Number of Subjects in PSD Veritas Arm|PSD Veritas is used as a buttress on stomach and/or GJ anastomosis.
1098047|NCT00566943|O1|Outcome|Number of Subjects in Control Arm|control arm where no buttress is used on stomach or GJ anastomosis staple lines
1098048|NCT00566943|O2|Outcome|Number of Subjects in PSD Veritas Arm Linear|PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis.
1098049|NCT00566943|O1|Outcome|Number of Subjects in Control Arm|control arm where no buttress is used on stomach or GJ anastomosis staple lines.
1098050|NCT00566943|O2|Outcome|PSD Veritas|PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis. Linear and circular refer to the shapes of the Veritas.
1098051|NCT00566943|O1|Outcome|Control|control arm where no buttress is used on stomach or GJ anastomosis staple lines.
1098052|NCT00566943|O2|Outcome|Number of Subjects in PSD Veritas Group|PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis.
1098053|NCT00566943|O1|Outcome|Number of Subjects in Control Group|control arm where no buttress is used on stomach or GJ anastomosis staple lines.
1098054|NCT00566943|E2|Reported Event|PSD Veritas|PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis. Linear and circular refer to the shapes of the Veritas.
1098055|NCT00566943|E1|Reported Event|Control|control arm where no buttress is used on stomach or GJ anastomosis staple lines.
1098056|NCT00566930|B4|Baseline|Total|Total of all reporting groups
1098057|NCT00566930|B3|Baseline|Spinal Manipulation and Exercises|Spinal manipulation + exercises
1098058|NCT00566930|B2|Baseline|Spinal Manipulation|spinal manipulation
1098059|NCT00566930|B1|Baseline|Control|control group with no treatment only regular assessment appointments
1098060|NCT00566930|P3|Participant Flow|Spinal Manipulation and Exercises|Spinal manipulation + exercises
1098061|NCT00566930|P2|Participant Flow|Spinal Manipulation|spinal manipulation
1098062|NCT00566930|P1|Participant Flow|Control|control group with no treatment only regular assessment appointments
1098063|NCT00566930|O3|Outcome|Spinal Manipulation and Exercises|Spinal manipulation + exercises
1098064|NCT00566930|O2|Outcome|Spinal Manipulation|spinal manipulation
1098065|NCT00566930|O1|Outcome|Control|control group with no treatment only regular assessment appointments
1098066|NCT00566930|E3|Reported Event|Spinal Manipulation and Exercises|Spinal manipulation + exercises
1098067|NCT00566930|E2|Reported Event|Spinal Manipulation|spinal manipulation
1098068|NCT00566930|E1|Reported Event|Control|control group with no treatment only regular assessment appointments
1098069|NCT00566735|B3|Baseline|Total|Total of all reporting groups
1098070|NCT00566735|B2|Baseline|Galantamine|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
1098071|NCT00566735|B1|Baseline|Placebo|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
1098072|NCT00566735|P2|Participant Flow|Galantamine|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
1098073|NCT00566735|P1|Participant Flow|Placebo|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
1098216|NCT00566111|O2|Outcome|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
1099766|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
1098074|NCT00566735|O2|Outcome|Galantamine|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
1098075|NCT00566735|O1|Outcome|Placebo|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
1098076|NCT00566735|O2|Outcome|Galantamine|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
1098077|NCT00566735|O1|Outcome|Placebo|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
1098078|NCT00566735|O2|Outcome|Galantamine|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
1098079|NCT00566735|O1|Outcome|Placebo|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
1098080|NCT00566735|E2|Reported Event|Galantamine|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
1098081|NCT00566735|E1|Reported Event|Placebo|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
1098082|NCT00566722|B4|Baseline|Total|Total of all reporting groups
1098120|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|
1098083|NCT00566722|B3|Baseline|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
1098084|NCT00566722|B2|Baseline|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
1098085|NCT00566722|B1|Baseline|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
1098086|NCT00566722|P3|Participant Flow|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
1098087|NCT00566722|P2|Participant Flow|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
1098088|NCT00566722|P1|Participant Flow|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
1098148|NCT00566709|E2|Reported Event|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
1098217|NCT00566111|O1|Outcome|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
1098089|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
1098090|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
1098091|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
1098121|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|
1098092|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
1098093|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
1098094|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
1098095|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
1098096|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
1098097|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
1098149|NCT00566709|E1|Reported Event|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
1098172|NCT00566631|E1|Reported Event|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
1098098|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
1098099|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
1098100|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
1098101|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
1098102|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
1098103|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
1098104|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
1098105|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
1098106|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
1098150|NCT00566696|B1|Baseline|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
1098173|NCT00566254|B3|Baseline|Total|Total of all reporting groups
1098681|NCT00564902|P3|Participant Flow|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
1098107|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
1098108|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
1098109|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
1098110|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
1098111|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
1098112|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
1098113|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
1098114|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
1098115|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
1098151|NCT00566696|P1|Participant Flow|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
1098213|NCT00566111|O1|Outcome|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
1098116|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
1098117|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
1098118|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
1098122|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
1098123|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
1098124|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
1098125|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
1098126|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
1098127|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
1098171|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
1098128|NCT00566722|E3|Reported Event|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
1098129|NCT00566722|E2|Reported Event|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
1098130|NCT00566722|E1|Reported Event|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
1098131|NCT00566709|B3|Baseline|Total|Total of all reporting groups
1098284|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098132|NCT00566709|B2|Baseline|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
1098133|NCT00566709|B1|Baseline|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
1098134|NCT00566709|P2|Participant Flow|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
1098135|NCT00566709|P1|Participant Flow|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
1098136|NCT00566709|O2|Outcome|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
1098137|NCT00566709|O1|Outcome|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
1098138|NCT00566709|O2|Outcome|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
1098139|NCT00566709|O1|Outcome|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
1098140|NCT00566709|O2|Outcome|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
1098141|NCT00566709|O1|Outcome|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
1098142|NCT00566709|O2|Outcome|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
1098143|NCT00566709|O1|Outcome|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
1098144|NCT00566709|O2|Outcome|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
1098145|NCT00566709|O1|Outcome|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
1098146|NCT00566709|O2|Outcome|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
1098147|NCT00566709|O1|Outcome|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
1098214|NCT00566111|O2|Outcome|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
1098152|NCT00566696|O1|Outcome|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
1098153|NCT00566696|O1|Outcome|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
1098154|NCT00566696|O1|Outcome|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
1098155|NCT00566696|O1|Outcome|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
1098156|NCT00566696|O1|Outcome|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
1098702|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
1098157|NCT00566696|E1|Reported Event|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
1098158|NCT00566631|B1|Baseline|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
1098159|NCT00566631|P1|Participant Flow|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
1098160|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
1098161|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
1098162|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
1098163|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
1098164|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
1098165|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
1098166|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
1098167|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
1098168|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
1098169|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
1098170|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
1098215|NCT00566111|O1|Outcome|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
1098789|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
1098174|NCT00566254|B2|Baseline|Zonisamide|Participants had a starting dose of 1 mg/kg/day of Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
1098175|NCT00566254|B1|Baseline|Placebo|Participants had a starting dose of 1 mg/kg/day of placebo matching Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
1098176|NCT00566254|P2|Participant Flow|Zonisamide|Participants had a starting dose of 1 mg/kg/day of Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
1098177|NCT00566254|P1|Participant Flow|Placebo|Participants had a starting dose of 1 mg/kg/day of placebo matching Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
1098178|NCT00566254|O2|Outcome|Zonisamide|Participants had a starting dose of 1 mg/kg/day of Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
1098179|NCT00566254|O1|Outcome|Placebo|Participants had a starting dose of 1 mg/kg/day of placebo matching Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
1098285|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1104218|NCT00552669|B2|Baseline|Drug Eluting Stents|Any Drug Eluting Stents
1098180|NCT00566254|O2|Outcome|Zonisamide|Participants had a starting dose of 1 mg/kg/day of Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
1098181|NCT00566254|O1|Outcome|Placebo|Participants had a starting dose of 1 mg/kg/day of placebo matching Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
1098182|NCT00566254|O2|Outcome|Zonisamide|Participants had a starting dose of 1 mg/kg/day of Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
1098183|NCT00566254|O1|Outcome|Placebo|Participants had a starting dose of 1 mg/kg/day of placebo matching Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
1098184|NCT00566254|O2|Outcome|Zonisamide|Participants had a starting dose of 1 mg/kg/day of Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
1098185|NCT00566254|O1|Outcome|Placebo|Participants had a starting dose of 1 mg/kg/day of placebo matching Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
1098186|NCT00566254|E2|Reported Event|Zonisamide|Participants had a starting dose of 1 mg/kg/day of Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
1098187|NCT00566254|E1|Reported Event|Placebo|Participants had a starting dose of 1 mg/kg/day of placebo matching Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
1098188|NCT00566150|B3|Baseline|Total|Total of all reporting groups
1098189|NCT00566150|B2|Baseline|Placebo|Subjects assigned to placebo control group.
1098190|NCT00566150|B1|Baseline|Levetiracetam|Subjects on active study medication.
1098191|NCT00566150|P2|Participant Flow|Placebo|Subjects assigned to placebo control group.
1098192|NCT00566150|P1|Participant Flow|Levetiracetam|Subjects on active study medication.
1098193|NCT00566150|O2|Outcome|Placebo|Subjects assigned to placebo control group.
1098194|NCT00566150|O1|Outcome|Levetiracetam|Subjects on active study medication.
1098195|NCT00566150|O2|Outcome|Placebo|Subjects assigned to placebo control group.
1098196|NCT00566150|O1|Outcome|Levetiracetam|Subjects on active study medication.
1098197|NCT00566150|O2|Outcome|Placebo|Subjects assigned to placebo control group.
1098198|NCT00566150|O1|Outcome|Levetiracetam|Subjects on active study medication.
1098199|NCT00566150|O2|Outcome|Placebo|Subjects assigned to placebo control group.
1098200|NCT00566150|O1|Outcome|Levetiracetam|Subjects on active study medication.
1098201|NCT00566150|E2|Reported Event|Placebo|Subjects assigned to placebo control group.
1098202|NCT00566150|E1|Reported Event|Levetiracetam|Subjects on active study medication.
1098203|NCT00566111|B3|Baseline|Total|Total of all reporting groups
1098204|NCT00566111|B2|Baseline|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
1098205|NCT00566111|B1|Baseline|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
1098206|NCT00566111|P2|Participant Flow|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
1098207|NCT00566111|P1|Participant Flow|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
1098208|NCT00566111|O2|Outcome|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
1098209|NCT00566111|O1|Outcome|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
1098210|NCT00566111|O2|Outcome|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
1098211|NCT00566111|O1|Outcome|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
1098212|NCT00566111|O2|Outcome|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
1098218|NCT00566111|E2|Reported Event|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
1098219|NCT00566111|E1|Reported Event|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
1098220|NCT00566020|B1|Baseline|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
1098221|NCT00566020|P2|Participant Flow|Lamotrigine - Long-term Administration Phase|Lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
1098222|NCT00566020|P1|Participant Flow|Lamotrigine - Dosage Adjustment Phase|Lamotrigine 12.5 milligrams per day (mg/day) to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation
1098223|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
1098224|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
1098225|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
1098226|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
1098227|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
1098228|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
1098229|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
1098230|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
1098231|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
1098232|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
1098233|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
1098234|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
1098235|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
1098236|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
1098237|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
1098238|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
1098790|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
1098239|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
1098240|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
1098241|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
1098242|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
1098243|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
1098244|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 milligrams per day (mg/day) to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
1098245|NCT00566020|E1|Reported Event|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
1098246|NCT00565812|B4|Baseline|Total|Total of all reporting groups
1098247|NCT00565812|B3|Baseline|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098248|NCT00565812|B2|Baseline|SD-6010 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098249|NCT00565812|B1|Baseline|SD-6010 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098250|NCT00565812|P3|Participant Flow|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098251|NCT00565812|P2|Participant Flow|SD-6010 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098252|NCT00565812|P1|Participant Flow|SD-6010 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098253|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098254|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098255|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098256|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098257|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098258|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098259|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098260|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098261|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098262|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098263|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098264|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098265|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098266|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098267|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098268|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098269|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098270|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098271|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098272|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1099767|NCT00561600|E2|Reported Event|Pinnacle Acetabular Cup System|
1098273|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098274|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098275|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098276|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098277|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098278|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098279|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098280|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098281|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098282|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098283|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098286|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098287|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098288|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098289|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098290|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098291|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098292|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098293|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098294|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098295|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098296|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098297|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098298|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098299|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098300|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098301|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098302|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098303|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098304|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098305|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098306|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098307|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098308|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098309|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098310|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098311|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098312|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098313|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098314|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098791|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
1098315|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098316|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098317|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098318|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098319|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098320|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098321|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098322|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098323|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098324|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098325|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098326|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098327|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098328|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098329|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098330|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098331|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098332|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098333|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098334|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098335|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098336|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098337|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098338|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098339|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098340|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098341|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098342|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098343|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098344|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098345|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098346|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098347|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098348|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098349|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098350|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098351|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098352|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098353|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098354|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098355|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098356|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098792|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
1098357|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098358|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098359|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098360|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098361|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098362|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098363|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098364|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098365|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098366|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098367|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098368|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098369|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098370|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098371|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098372|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098373|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098374|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098375|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098376|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098377|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098378|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098379|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098380|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098381|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098382|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098383|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098384|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098385|NCT00565812|E3|Reported Event|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
1098386|NCT00565812|E2|Reported Event|SD-6010 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
1098387|NCT00565812|E1|Reported Event|SD-6010 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
1098388|NCT00565747|B3|Baseline|Total|Total of all reporting groups
1098389|NCT00565747|B2|Baseline|Control Culture|Culture without GM-CSF
1098390|NCT00565747|B1|Baseline|Test Culture|Culture with 2 ng/ml GM-CSF
1098391|NCT00565747|P2|Participant Flow|Control Culture|Culture without GM-CSF
1098392|NCT00565747|P1|Participant Flow|Test Culture|Culture with 2 ng/ml GM-CSF
1098393|NCT00565747|O2|Outcome|Control Culture|Culture without GM-CSF
1098394|NCT00565747|O1|Outcome|Test Culture|Culture with 2 ng/ml GM-CSF
1098395|NCT00565747|O2|Outcome|Control Culture|Culture without GM-CSF
1098396|NCT00565747|O1|Outcome|Test Culture|Culture with 2 ng/ml GM-CSF
1098397|NCT00565747|O2|Outcome|Control Culture|Culture without GM-CSF
1098398|NCT00565747|O1|Outcome|Test Culture|Culture with 2 ng/ml GM-CSF
1098399|NCT00565747|E2|Reported Event|Control Culture|Culture without GM-CSF
1098400|NCT00565747|E1|Reported Event|Test Culture|Culture with 2 ng/ml GM-CSF
1098401|NCT00565721|B1|Baseline|Safety With Fluciclatide Injection|The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)).
1098402|NCT00565721|P1|Participant Flow|Fluciclatide Injection|The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)).
1098403|NCT00565721|O1|Outcome|Correlation Between SUVR_55_blood and αvβ5 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
1099768|NCT00561600|E1|Reported Event|ASR XL Acetabular Cup System|
1098404|NCT00565721|O1|Outcome|Correlation Between SUVw_55 and αvβ5 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
1098405|NCT00565721|O1|Outcome|Correlation Between VT_inp-Logan and αvβ5 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
1098406|NCT00565721|O1|Outcome|Correlation Between Ki_inp-Patlak and αvβ5 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
1098407|NCT00565721|O1|Outcome|Correlation Between SUVR_55_blood and αvβ5 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.
1098408|NCT00565721|O1|Outcome|Correlation Between SUVw_55 and αvβ5 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.
1098409|NCT00565721|O1|Outcome|Correlation Between SUVR_55_blood and αvβ3 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
1098410|NCT00565721|O1|Outcome|Correlation Between SUVw_55 and αvβ3 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
1098411|NCT00565721|O1|Outcome|Correlation Between VT_inp-Logan and αvβ3 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
1098412|NCT00565721|O1|Outcome|Correlation Between Ki_inp-Patlak and αvβ3 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
1098413|NCT00565721|O1|Outcome|Correlation Between SUVR_55_blood and αvβ3 Optical Density|Correlation between Imaging parameters. The selected imaging parameters that reflected (18F) Fluciclatide tracer uptake and retention.
1098414|NCT00565721|O1|Outcome|Correlation Between SUVw_55 and αvβ3 Optical Density|Correlation between Imaging parameters. The selected imaging parameters that reflected (18F) Fluciclatide tracer uptake and retention.
1098415|NCT00565721|O1|Outcome|Correlation Between VT_inp-Logan and αvβ5 Optical Density|The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)). Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
1098416|NCT00565721|O1|Outcome|Correlation Between Ki_inp-Patlak αvβ5 Optical Density|The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)). Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors for the Full Analysis Set (FAS) subjects.
1098417|NCT00565721|O1|Outcome|Correlation Between VT_inp-Logan and αvβ3 Optical Density|Correlation between Imaging parameters. The selected imaging parameters that reflected (18F) Fluciclatide tracer uptake and retention.
1098418|NCT00565721|O1|Outcome|Correlation Between Ki_inp-Patlak and αvβ3 Optical Density|Correlation between Imaging parameters. The selected imaging parameters that reflected (18F) Fluciclatide tracer uptake and retention.
1098419|NCT00565721|E1|Reported Event|Fluciclatide Injection|The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)).
1098420|NCT00565643|B3|Baseline|Total|Total of all reporting groups
1098421|NCT00565643|B2|Baseline|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
1098422|NCT00565643|B1|Baseline|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
1098423|NCT00565643|P2|Participant Flow|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
1098424|NCT00565643|P1|Participant Flow|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
1098425|NCT00565643|O2|Outcome|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
1098426|NCT00565643|O1|Outcome|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of initial cesarean delivery
1098427|NCT00565643|O2|Outcome|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
1098428|NCT00565643|O1|Outcome|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of initial cesarean delivery
1098429|NCT00565643|O2|Outcome|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
1098430|NCT00565643|O1|Outcome|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of initial cesarean delivery
1098431|NCT00565643|O2|Outcome|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
1098432|NCT00565643|O1|Outcome|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of initial cesarean delivery
1098433|NCT00565643|O2|Outcome|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
1098434|NCT00565643|O1|Outcome|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of initial cesarean delivery
1098435|NCT00565643|O2|Outcome|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
1098436|NCT00565643|O1|Outcome|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
1098437|NCT00565643|O2|Outcome|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
1098438|NCT00565643|O1|Outcome|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
1098439|NCT00565643|E2|Reported Event|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
1098440|NCT00565643|E1|Reported Event|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
1098441|NCT00565604|B1|Baseline|Short Catheter Delivery|Patients with duplex ultrasound documented incompetent perforator veins will be treated using a short catheter delivery system in conjunction with a Bright Tip Laser fiber.
1098442|NCT00565604|P1|Participant Flow|Short Catheter Delivery|Patients with duplex ultrasound documented incompetent perforator veins will be treated using a short catheter delivery system in conjunction with a Bright Tip Laser fiber.
1098443|NCT00565604|O1|Outcome|Short Catheter Delivery|Patients with duplex ultrasound documented incompetent perforator veins will be treated using a short catheter delivery system in conjunction with a Bright Tip Laser fiber.
1098444|NCT00565604|O1|Outcome|Short Catheter Delivery|Patients with duplex ultrasound documented incompetent perforator veins will be treated using a short catheter delivery system in conjunction with a Bright Tip Laser fiber.
1098445|NCT00565604|O1|Outcome|Short Catheter Delivery|Patients with duplex ultrasound documented incompetent perforator veins will be treated using a short catheter delivery system in conjunction with a Bright Tip Laser fiber.
1098703|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
1098446|NCT00565604|O1|Outcome|Short Catheter Delivery|Patients with duplex ultrasound documented incompetent perforator veins will be treated using a short catheter delivery system in conjunction with a Bright Tip Laser fiber.
1098447|NCT00565604|E1|Reported Event|Short Catheter Delivery|Patients with duplex ultrasound documented incompetent perforator veins will be treated using a short catheter delivery system in conjunction with a Bright Tip Laser fiber.
1098448|NCT00565461|B5|Baseline|Total|Total of all reporting groups
1098449|NCT00565461|B4|Baseline|Self Administered (Non-clinic)|"40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
1098450|NCT00565461|B3|Baseline|Self Administered (In-clinic)|"40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
1098451|NCT00565461|B2|Baseline|Clinician Administered (Thigh)|"40 subjects will be pretreated with SPS:Buffer and a patch containing 37.5ug will be applied on the left deltoid by the Clinician. Fourteen days later, the same procedure will occur on the left thigh by the clinician.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
1098452|NCT00565461|B1|Baseline|Clinician Administered (Deltoid)|"40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT patch on the left deltoid by a Clinician on Day 0. Two weeks later will have the same treatment repeated on the right deltoid by the clinician~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
1098453|NCT00565461|P4|Participant Flow|Self Administered (Non-clinic)|"40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
1098454|NCT00565461|P3|Participant Flow|Self Administered (In-clinic)|"40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
1098455|NCT00565461|P2|Participant Flow|Clinician Administered (Thigh)|"40 subjects will be pretreated with SPS:Buffer and a patch containing 37.5ug will be applied on the left deltoid by the Clinician. Fourteen days later, the same procedure will occur on the left thigh by the clinician.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
1098456|NCT00565461|P1|Participant Flow|Clinician Administered (Deltoid)|"40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT patch on the left deltoid by a Clinician on Day 0. Two weeks later will have the same treatment repeated on the right deltoid by the clinician~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
1098457|NCT00565461|O2|Outcome|Self Administered (In-clinic & Non-clinic)|"st vaccination: administered by clinician; location: deltoid~nd vaccination: self-administration either in-clinic or away from the clinic; location: thigh"
1098458|NCT00565461|O1|Outcome|Clinician Administered (Deltoid/ Thigh)|"st vaccination: administered by clinician; location: deltoid~nd vaccination: administered by clinician; location: thigh"
1098459|NCT00565461|O2|Outcome|Self Administered (In-clinic & Non-clinic)|"st vaccination: administered by clinician; location: deltoid~nd vaccination: self-administration either in-clinic or away from the clinic; location: thigh"
1098460|NCT00565461|O1|Outcome|Clinician Administered (Deltoid/ Thigh)|"st vaccination: administered by clinician; location: deltoid~nd vaccination: administered by clinician; location: thigh"
1098461|NCT00565461|O2|Outcome|Self Administered (In-clinic & Non-clinic)|"st vaccination: administered by clinician; location: deltoid~nd vaccination: self-administration either in-clinic or away from the clinic; location: thigh"
1098462|NCT00565461|O1|Outcome|Clinician Administered (Deltoid/ Thigh)|"st vaccination: administered by clinician; location: deltoid~nd vaccination: administered by clinician; location: thigh"
1098488|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098463|NCT00565461|E4|Reported Event|Self Administered (Non-clinic)|"40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
1098464|NCT00565461|E3|Reported Event|Self Administered (In-clinic)|"40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
1098465|NCT00565461|E2|Reported Event|Clinician Administered (Thigh)|"40 subjects will be pretreated with SPS:Buffer and a patch containing 37.5ug will be applied on the left deltoid by the Clinician. Fourteen days later, the same procedure will occur on the left thigh by the clinician.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
1098466|NCT00565461|E1|Reported Event|Clinician Administered (Deltoid)|"40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT patch on the left deltoid by a Clinician on Day 0. Two weeks later will have the same treatment repeated on the right deltoid by the clinician~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
1098467|NCT00565448|B3|Baseline|Total|Total of all reporting groups
1098468|NCT00565448|B2|Baseline|Cisplatin/5-FU|"Cisplatin 80 mg/m² on Day 1 and 5-Fluorouracil 1000 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.~Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks."
1098633|NCT00565058|P2|Participant Flow|Phase II Arm|Phase II PD Study (Early GTI-2040) Group: In the Phase II PD Study Group, GTI-2040 is given 24 hours prior to addition of HiDAC.
1098469|NCT00565448|B1|Baseline|Docetaxel /Cisplatin/5-FU|"Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.~Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks."
1098470|NCT00565448|P2|Participant Flow|Cisplatin/5-FU|"Cisplatin 80 mg/m² on Day 1 and 5-Fluorouracil 1000 mg/m²/day Days 1 to 4 every 3 weeks as induction therapy.~Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks."
1098471|NCT00565448|P1|Participant Flow|Docetaxel /Cisplatin/5-FU|"Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.~Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks."
1098472|NCT00565448|O2|Outcome|Cisplatin/5-FU|"Cisplatin 80 mg/m² on Day 1 and 5-Fluorouracil 1000 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.~Consolidation Treatment: Radiation for 6 weeks and 3 cycles of platinum 100 mg/m² every 3 weeks."
1098473|NCT00565448|O1|Outcome|Docetaxel /Cisplatin/5-FU|"Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.~Consolidation Treatment: Radiation for 6 weeks and 3 cycles of platinum 100 mg/m² every 3 weeks."
1098474|NCT00565448|O2|Outcome|Cisplatin/5-FU|"Cisplatin 80 mg/m² on Day 1 and 5-Fluorouracil 1000 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.~Consolidation Treatment: Radiation for 6 weeks and 3 cycles of platinum 100 mg/m² every 3 weeks."
1098475|NCT00565448|O1|Outcome|Docetaxel /Cisplatin/5-FU|"Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.~Consolidation Treatment: Radiation for 6 weeks and 3 cycles of platinum 100 mg/m² every 3 weeks."
1098476|NCT00565448|O1|Outcome|Docetaxel/Cisplatin/5-FU|Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy
1098477|NCT00565448|O2|Outcome|Cisplatin/5-FU|Cisplatin 80 mg/m² on Day 1 and 5-Fluorouracil 1000 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy
1098478|NCT00565448|O1|Outcome|Docetaxel /Cisplatin/5-FU|Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy
1098479|NCT00565448|E2|Reported Event|Docetaxel /Cisplatin/5-FU|"Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.~Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks."
1098480|NCT00565448|E1|Reported Event|Cisplatin/5-FU|"Cisplatin 80 mg/m² on Day 1 and 5-Fluorouracil 1000 mg/m²/day Days 1 to 4 every 3 weeks as induction therapy.~Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks."
1098481|NCT00565409|B1|Baseline|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
1098482|NCT00565409|P4|Participant Flow|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ 3.2 from Week 12 visit through Week 36.
1098483|NCT00565409|P3|Participant Flow|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ 3.2 from Week 12 visit through Week 36.
1098484|NCT00565409|P2|Participant Flow|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) less than or equal to (≤) 3.2 at Week 36 and an average DAS28 less than or equal to (≤) 3.2 from Week 12 visit through Week 36.
1098485|NCT00565409|P1|Participant Flow|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept (ETN) 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
1098486|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098487|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098489|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098490|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098491|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098492|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
1098493|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098494|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098704|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
1098495|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098496|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
1098497|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098498|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098499|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098500|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
1098501|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098502|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098503|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098504|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
1098505|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098506|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098507|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098508|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
1098509|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098510|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098511|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098512|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
1098677|NCT00564902|B4|Baseline|Total|Total of all reporting groups
1098513|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098514|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098515|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098516|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098517|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098634|NCT00565058|P1|Participant Flow|Pilot|Pilot PD Study (Delayed GTI-2040) Group: In the Pilot PD Study Group, addition of GTI-2040 is delayed until 24 hours after initiation of HiDAC.
1098518|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098519|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
1098520|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098521|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098522|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098523|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098524|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098525|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098526|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
1098527|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098528|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098529|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098530|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098531|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098532|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098533|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
1098534|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098535|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098678|NCT00564902|B3|Baseline|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
1098536|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098537|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098538|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098539|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098540|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
1104674|NCT00551707|P5|Participant Flow|Placebo|"placebo~placebo: placebo"
1098541|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098542|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098543|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098544|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098545|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098546|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098547|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
1098548|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098549|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098550|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098551|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098552|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098553|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098554|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
1098555|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098556|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098557|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098558|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098793|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
1098559|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098560|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098561|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
1098562|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098563|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098564|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098565|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098566|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098567|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098568|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098569|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098570|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098571|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098572|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098573|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098574|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
1098575|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098576|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098577|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098578|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
1098579|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098580|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098581|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
1098794|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
1098582|NCT00565409|E4|Reported Event|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ 3.2 from Week 12 visit through Week 36.
1098583|NCT00565409|E3|Reported Event|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ 3.2 from Week 12 visit through Week 36.
1098584|NCT00565409|E2|Reported Event|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) less than or equal to (≤) 3.2 at Week 36 and an average DAS28 less than or equal to (≤) 3.2 from Week 12 visit through Week 36.
1098585|NCT00565409|E1|Reported Event|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept (ETN) 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
1098586|NCT00565370|B1|Baseline|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib
1098696|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
1098587|NCT00565370|P1|Participant Flow|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib Level 1 sorafenib 400 mg/d, capecitabine 1,600 mg/m2/d, cisplatin 80 mg/m2 Level 2 sorafenib 800 mg/d, capecitabine 1,600 mg/m2/d, cisplatin 80 mg/m2 Level 3 sorafenib 800 mg/d, capecitabine 2,000 mg/m2/d, cisplatin 80 mg/m2 Level 1A sorafenib 800 mg/d, capecitabine 1,600 mg/m2/d, cisplatin 60 mg/m2
1098588|NCT00565370|O1|Outcome|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib
1098589|NCT00565370|O1|Outcome|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib
1098590|NCT00565370|O1|Outcome|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib
1098591|NCT00565370|O1|Outcome|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib
1098592|NCT00565370|O1|Outcome|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib
1098593|NCT00565370|E1|Reported Event|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib
1098594|NCT00565266|B1|Baseline|All Participants|All participants randomized into the six-sequence crossover study
1098595|NCT00565266|P1|Participant Flow|All Participants|"All participants randomized into the six-sequence crossover study. All TALC participants underwent three 16-week treatment periods:~tiotropium bromide inhalation powder 18 mcg once daily (Tio) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)~salmeterol xinafoate inhalation powder 50 mcg twice daily (LABA) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)~beclomethasone dipropionate 160 mcg twice daily (2xICS)"
1098596|NCT00565266|O3|Outcome|2xICS|beclomethasone dipropionate 160 mcg twice daily (2xICS)
1098597|NCT00565266|O2|Outcome|LABA + 1xICS|salmeterol xinafoate inhalation powder 50 mcg twice daily (LABA) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
1098598|NCT00565266|O1|Outcome|Tio + 1xICS|tiotropium bromide inhalation powder 18 mcg once daily (Tio) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
1098599|NCT00565266|E3|Reported Event|2xICS|beclomethasone dipropionate 160 mcg twice daily (2xICS)
1098600|NCT00565266|E2|Reported Event|LABA + 1xICS|salmeterol xinafoate inhalation powder 50 mcg twice daily (LABA) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
1098601|NCT00565266|E1|Reported Event|Tio + 1xICS|tiotropium bromide inhalation powder 18 mcg once daily (Tio) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
1098602|NCT00565136|B1|Baseline|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
1098603|NCT00565136|P1|Participant Flow|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
1098604|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
1098605|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
1098606|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
1098607|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
1098608|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
1098609|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
1098610|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
1098611|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
1098612|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
1098613|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
1098614|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
1098615|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
1098616|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
1098617|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
1098618|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
1098619|NCT00565136|E1|Reported Event|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
1098620|NCT00565084|B1|Baseline|Overall Study|
1098621|NCT00565084|P3|Participant Flow|Ibuprofen-Placebo-Placebo|Single dose ibuprofen 800 mg; first single dose placebo; second single dose placebo
1098622|NCT00565084|P2|Participant Flow|Placebo-Ibuprofen-Placebo|First single dose placebo; single dose ibuprofen 800 mg; second single dose placebo
1098623|NCT00565084|P1|Participant Flow|Placebo-Placebo-Ibuprofen|First single dose placebo; second single dose placebo; single dose ibuprofen 800 mg
1098624|NCT00565084|O3|Outcome|Placebo 2|Second Single dose placebo
1098625|NCT00565084|O2|Outcome|Placebo 1|First Single dose placebo
1098626|NCT00565084|O1|Outcome|Ibuprofen|Single dose ibuprofen 800 mg
1098627|NCT00565084|E3|Reported Event|Ibuprofen-Placebo-Placebo|Single dose ibuprofen 800 mg; first single dose placebo; second single dose placebo
1098628|NCT00565084|E2|Reported Event|Placebo-Ibuprofen-Placebo|First single dose placebo; single dose ibuprofen 800 mg; second single dose placebo
1098629|NCT00565084|E1|Reported Event|Placebo-Placebo-Ibuprofen|First single dose placebo; second single dose placebo; single dose ibuprofen 800 mg
1098630|NCT00565058|B3|Baseline|Total|Total of all reporting groups
1098631|NCT00565058|B2|Baseline|Phase II Arm|Phase II PD Study (Early GTI-2040) Group: In the Phase II PD Study Group, GTI-2040 is given 24 hours prior to addition of HiDAC.
1098632|NCT00565058|B1|Baseline|Pilot|Pilot PD Study (Delayed GTI-2040) Group: In the Pilot PD Study Group, addition of GTI-2040 is delayed until 24 hours after initiation of HiDAC.
1098705|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
1098635|NCT00565058|O2|Outcome|Phase II Arm|Phase II PD Study (Early GTI-2040) Group: In the Phase II PD Study Group, GTI-2040 is given 24 hours prior to addition of HiDAC.
1098636|NCT00565058|O1|Outcome|Pilot|Pilot PD Study (Delayed GTI-2040) Group: In the Pilot PD Study Group, addition of GTI-2040 is delayed until 24 hours after initiation of HiDAC.
1098637|NCT00565058|O2|Outcome|Phase II Arm|Phase II PD Study (Early GTI-2040) Group: In the Phase II PD Study Group, GTI-2040 is given 24 hours prior to addition of HiDAC.
1098638|NCT00565058|O1|Outcome|Pilot|Pilot PD Study (Delayed GTI-2040) Group: In the Pilot PD Study Group, addition of GTI-2040 is delayed until 24 hours after initiation of HiDAC.
1098639|NCT00565058|E2|Reported Event|Phase II Arm|Phase II PD Study (Early GTI-2040) Group: In the Phase II PD Study Group, GTI-2040 is given 24 hours prior to addition of HiDAC.
1098640|NCT00565058|E1|Reported Event|Pilot|Pilot PD Study (Delayed GTI-2040) Group: In the Pilot PD Study Group, addition of GTI-2040 is delayed until 24 hours after initiation of HiDAC.
1098641|NCT00565045|B3|Baseline|Total|Total of all reporting groups
1098642|NCT00565045|B2|Baseline|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.~Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~Therapy sessions are done without the stimulation system"
1098643|NCT00565045|B1|Baseline|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand~A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity~Therapy sessions are done with the subject being assisted by the CCFES system."
1098644|NCT00565045|P2|Participant Flow|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.~Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~Therapy sessions are done without the stimulation system"
1098645|NCT00565045|P1|Participant Flow|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand~A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity~Therapy sessions are done with the subject being assisted by the CCFES system."
1098646|NCT00565045|O2|Outcome|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.~Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~Therapy sessions are done without the stimulation system"
1098647|NCT00565045|O1|Outcome|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand~A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity~Therapy sessions are done with the subject being assisted by the CCFES system."
1098648|NCT00565045|O2|Outcome|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.~Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~Therapy sessions are done without the stimulation system"
1098649|NCT00565045|O1|Outcome|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand~A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity~Therapy sessions are done with the subject being assisted by the CCFES system."
1098650|NCT00565045|O2|Outcome|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.~Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~Therapy sessions are done without the stimulation system"
1098679|NCT00564902|B2|Baseline|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
1098680|NCT00564902|B1|Baseline|Lutein|Lutein 9 mg per day
1098651|NCT00565045|O1|Outcome|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand~A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity~Therapy sessions are done with the subject being assisted by the CCFES system."
1098652|NCT00565045|O2|Outcome|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.~Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~Therapy sessions are done without the stimulation system"
1098653|NCT00565045|O1|Outcome|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand~A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity~Therapy sessions are done with the subject being assisted by the CCFES system."
1098697|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
1098698|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
1098699|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
1098654|NCT00565045|O2|Outcome|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.~Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~Therapy sessions are done without the stimulation system"
1098655|NCT00565045|O1|Outcome|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand~A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity~Therapy sessions are done with the subject being assisted by the CCFES system."
1098656|NCT00565045|E2|Reported Event|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.~Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~Therapy sessions are done without the stimulation system"
1098657|NCT00565045|E1|Reported Event|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand~A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity~Therapy sessions are done with the subject being assisted by the CCFES system."
1098658|NCT00564954|B3|Baseline|Total|Total of all reporting groups
1098659|NCT00564954|B2|Baseline|Placebo Then Dex-methylphenidate Hydrochloride (Focalin XR)|Period 1: One week of placebo taken once daily in the morning followed by Period 2: one week of one 20 mg capsule of Focalin XR taken once daily in the morning.
1098660|NCT00564954|B1|Baseline|Dex-methylphenidate Hydrochloride (Focalin XR) Then Placebo|Period 1: One 20 mg capsule of Focalin XR taken once daily in the morning for one week followed by Period 2: one week of placebo taken once daily in the morning.
1098661|NCT00564954|P2|Participant Flow|Placebo Then Dex-methylphenidate Hydrochloride (Focalin XR)|Period 1: One week of placebo taken once daily in the morning followed by Period 2: one week of one 20 mg capsule of Focalin XR taken once daily in the morning.
1098662|NCT00564954|P1|Participant Flow|Dex-methylphenidate Hydrochloride (Focalin XR) Then Placebo|Period 1: One 20 mg capsule of Focalin XR taken once daily in the morning for one week followed by Period 2: one week of placebo taken once daily in the morning.
1098663|NCT00564954|O2|Outcome|Placebo|Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
1098664|NCT00564954|O1|Outcome|Dex-methylphenidate Hydrochloride (Focalin XR)|Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
1098665|NCT00564954|O2|Outcome|Placebo|Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
1098666|NCT00564954|O1|Outcome|Dex-methylphenidate Hydrochloride (Focalin XR)|Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
1098667|NCT00564954|O2|Outcome|Placebo|Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
1098668|NCT00564954|O1|Outcome|Dex-methylphenidate Hydrochloride (Focalin XR)|Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
1098669|NCT00564954|O2|Outcome|Placebo|Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
1098670|NCT00564954|O1|Outcome|Dex-methylphenidate Hydrochloride (Focalin XR)|Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
1098671|NCT00564954|O2|Outcome|Placebo|Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
1098672|NCT00564954|O1|Outcome|Dex-methylphenidate Hydrochloride (Focalin XR)|Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
1098673|NCT00564954|O2|Outcome|Placebo|Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
1098674|NCT00564954|O1|Outcome|Dex-methylphenidate Hydrochloride (Focalin XR)|Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
1098675|NCT00564954|E2|Reported Event|Placebo|Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
1098676|NCT00564954|E1|Reported Event|Dex-methylphenidate Hydrochloride (Focalin XR)|Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
1098682|NCT00564902|P2|Participant Flow|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
1098683|NCT00564902|P1|Participant Flow|Lutein|Lutein 9 mg per day
1098684|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
1098685|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
1098686|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
1098687|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
1098688|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
1098689|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
1098690|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
1098691|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
1098692|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
1098693|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
1098694|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
1098695|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
1098706|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
1098707|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
1098708|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
1098709|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
1098710|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
1098711|NCT00564902|E3|Reported Event|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
1098712|NCT00564902|E2|Reported Event|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
1098713|NCT00564902|E1|Reported Event|Lutein|Lutein 9 mg per day
1098714|NCT00564889|B1|Baseline|Len/Cyc/Dex|Lenalidomide (Len) 15mg daily (days 1-21); Cyclophosphamide (Cyc) 300 mg/m^2 (days 1, 8, 15); Dexamethasone (Dex) 40 mg weekly
1098715|NCT00564889|P1|Participant Flow|Len/Cyc/Dex|"Lenalidomide (Len) 15mg daily (days 1-21)~Cyclophosphamide (Cyc) 300 mg/m^2 (days 1, 8, 15)~Dexamethasone (Dex) 40 mg weekly"
1098716|NCT00564889|O1|Outcome|Len/Cyc/Dex|Lenalidomide (Len) 15mg daily (days 1-21); Cyclophosphamide (Cyc) 300 mg/m^2 (days 1, 8, 15); Dexamethasone (Dex) 40 mg weekly
1098717|NCT00564889|O1|Outcome|Len/Cyc/Dex|Lenalidomide (Len) 15mg daily (days 1-21); Cyclophosphamide (Cyc) 300 mg/m^2 (days 1, 8, 15); Dexamethasone (Dex) 40 mg weekly
1098718|NCT00564889|O1|Outcome|Len/Cyc/Dex|Lenalidomide (Len) 15mg daily (days 1-21); Cyclophosphamide (Cyc) 300 mg/m^2 (days 1, 8, 15); Dexamethasone (Dex) 40 mg weekly
1098719|NCT00564889|O1|Outcome|Len/Cyc/Dex|Lenalidomide (Len) 15mg daily (days 1-21); Cyclophosphamide (Cyc) 300 mg/m^2 (days 1, 8, 15); Dexamethasone (Dex) 40 mg weekly
1098720|NCT00564889|O1|Outcome|Len/Cyc/Dex|Lenalidomide (Len) 15mg daily (days 1-21); Cyclophosphamide (Cyc) 300 mg/m^2 (days 1, 8, 15); Dexamethasone (Dex) 40 mg weekly
1098721|NCT00564889|E1|Reported Event|Len/Cyc/Dex|Dexamethasone (Dex) 40 mg weekly
1098722|NCT00564876|B1|Baseline|Neoadjuvant Dasatinib|Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
1098723|NCT00564876|P1|Participant Flow|Neoadjuvant Dasatinib|Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
1098724|NCT00564876|O1|Outcome|Neoadjuvant Dasatinib|Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
1098725|NCT00564876|O1|Outcome|Neoadjuvant Dasatinib|Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
1098726|NCT00564876|O1|Outcome|Neoadjuvant Dasatinib|Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
1098727|NCT00564876|O1|Outcome|Neoadjuvant Dasatinib|Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
1098728|NCT00564876|E1|Reported Event|Neoadjuvant Dasatinib|Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
1098729|NCT00564850|B1|Baseline|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
1098730|NCT00564850|P1|Participant Flow|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
1098731|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
1098732|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
1098733|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
1098734|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
1098735|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
1098736|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
1098737|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
1098738|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
1098739|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
1098740|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
1098741|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
1098742|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
1098743|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
1098744|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
1098745|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
1098746|NCT00564850|E1|Reported Event|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
1098747|NCT00564733|B1|Baseline|Chemotherapy|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT scan between days 18-21. Patients that are responding to treatment receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.Patients then receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT scan between days 18-21 of course 2.~carboplatin: Given IV~docetaxel: Given IV~gemcitabine hydrochloride: Given IV~paclitaxel: Given IV~computed tomography: Undergo FDG PET/CT~positron emission tomography: Undergo FDG PET/CT~fludeoxyglucose F 18: Given IV~imaging biomarker analysis: Correlative studies"
1098748|NCT00564733|P1|Participant Flow|Chemotherapy|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT scan between days 18-21. Patients that are responding to treatment receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.Patients then receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT scan between days 18-21 of course 2.~carboplatin: Given IV~docetaxel: Given IV~gemcitabine hydrochloride: Given IV~paclitaxel: Given IV~computed tomography: Undergo FDG PET/CT~positron emission tomography: Undergo FDG PET/CT~fludeoxyglucose F 18: Given IV~imaging biomarker analysis: Correlative studies"
1098749|NCT00564733|O1|Outcome|Chemotherapy|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT scan between days 18-21. Patients that are responding to treatment receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.Patients then receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT scan between days 18-21 of course 2.~carboplatin: Given IV~docetaxel: Given IV~gemcitabine hydrochloride: Given IV~paclitaxel: Given IV~computed tomography: Undergo FDG PET/CT~positron emission tomography: Undergo FDG PET/CT~fludeoxyglucose F 18: Given IV~imaging biomarker analysis: Correlative studies"
1098783|NCT00564629|P1|Participant Flow|Oral Acetaminophen (PO APAP) 1 g|group of subjects randomly selected to receive 1 g of oral acetaminophen as the study treatment
1098784|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
1098785|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
1098786|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
1098787|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
1098788|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
1098750|NCT00564733|E1|Reported Event|Chemotherapy|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT scan between days 18-21. Patients that are responding to treatment receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.Patients then receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT scan between days 18-21 of course 2.~carboplatin: Given IV~docetaxel: Given IV~gemcitabine hydrochloride: Given IV~paclitaxel: Given IV~computed tomography: Undergo FDG PET/CT~positron emission tomography: Undergo FDG PET/CT~fludeoxyglucose F 18: Given IV~imaging biomarker analysis: Correlative studies"
1098751|NCT00564681|B5|Baseline|Total|Total of all reporting groups
1098752|NCT00564681|B4|Baseline|Placebo (Normal Saline) / Botulinum Toxin Type A Formulation 2|Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A Formulation 2 for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
1098753|NCT00564681|B3|Baseline|Placebo (Normal Saline) / Botulinum Toxin Type A|Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
1098754|NCT00564681|B2|Baseline|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
1098755|NCT00564681|B1|Baseline|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
1098756|NCT00564681|P4|Participant Flow|Placebo (Normal Saline) / Botulinum Toxin Type A Formulation 2|Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A Formulation 2 for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
1098757|NCT00564681|P3|Participant Flow|Placebo (Normal Saline) / Botulinum Toxin Type A|Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
1098758|NCT00564681|P2|Participant Flow|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
1098759|NCT00564681|P1|Participant Flow|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
1098760|NCT00564681|O3|Outcome|Placebo (Normal Saline)|Intramuscular injections into the affected muscles. Includes all patients who received placebo in Cycle 1.
1098761|NCT00564681|O2|Outcome|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
1098762|NCT00564681|O1|Outcome|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
1098763|NCT00564681|O3|Outcome|Placebo (Normal Saline)|Intramuscular injections into the affected muscles. Includes all patients who received placebo in Cycle 1.
1098764|NCT00564681|O2|Outcome|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
1098765|NCT00564681|O1|Outcome|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
1098766|NCT00564681|O3|Outcome|Placebo (Normal Saline)|Intramuscular injections into the affected muscles. Includes all patients who received placebo in Cycle 1.
1098767|NCT00564681|O2|Outcome|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
1098768|NCT00564681|O1|Outcome|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
1098769|NCT00564681|O3|Outcome|Placebo (Normal Saline)|Intramuscular injections into the affected muscles. Includes all patients who received placebo in Cycle 1.
1098770|NCT00564681|O2|Outcome|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
1098771|NCT00564681|O1|Outcome|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
1098772|NCT00564681|O3|Outcome|Placebo (Normal Saline)|Intramuscular injections into the affected muscles. Includes all patients who received placebo in Cycle 1.
1098773|NCT00564681|O2|Outcome|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
1098774|NCT00564681|O1|Outcome|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
1098775|NCT00564681|E4|Reported Event|Placebo (Normal Saline) / Botulinum Toxin Type A Formulation 2|Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A Formulation 2 for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
1098776|NCT00564681|E3|Reported Event|Placebo (Normal Saline) / Botulinum Toxin Type A|Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
1098777|NCT00564681|E2|Reported Event|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
1098778|NCT00564681|E1|Reported Event|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
1098779|NCT00564629|B3|Baseline|Total|Total of all reporting groups
1098780|NCT00564629|B2|Baseline|IV APAP 1 g / 100 ml Solution|group of subjects randomly selected to receive 1 g of acetaminophen in 100 ml of intravenous solution and oral placebo as the study treatment
1098781|NCT00564629|B1|Baseline|PO APAP 1 g|group of subjects randomly selected to receive 1 g of oral acetaminophen and 100 ml of intravenous placebo solution as the study treatment
1098782|NCT00564629|P2|Participant Flow|Intravenous Acetaminophen (IV APAP) 1 g / 100 ml Solution|group of subjects randomly selected to receive 1 g /100 ml of intravenous acetaminophen solution as the study treatment
1098795|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
1098796|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
1098797|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
1098798|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
1098799|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
1098800|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
1098801|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
1098802|NCT00564629|E2|Reported Event|Intravenous Acetaminophen (IV APAP) 1 g / 100 ml Solution|group of subjects randomly selected to receive 1 g /100 ml of intravenous acetaminophen solution as the study treatment
1098803|NCT00564629|E1|Reported Event|Oral Acetaminophen (PO APAP) 1 g|group of subjects randomly selected to receive 1 g of oral acetaminophen as the study treatment
1098804|NCT00564486|B4|Baseline|Total|Total of all reporting groups
1098805|NCT00564486|B3|Baseline|IV Acetaminophen 650 mg|All subjects randomized to receive IV Acetaminophen 650 mg
1098806|NCT00564486|B2|Baseline|IV Acetaminophen 1 gm|All subjects randomized to receive IV Acetaminophen 1 gm
1098807|NCT00564486|B1|Baseline|IV Placebo|All subjects randomized to receive IV Placebo 100 ml and IV placebo 65 ml groups combined
1098808|NCT00564486|P4|Participant Flow|IV Placebo (65 ml)|IV Placebo 65 ml dosed every every 4 hours for 24 hours (6 doses total).
1098809|NCT00564486|P3|Participant Flow|IV Acetaminophen 650 mg|IV Acetaminophen 650 mg dosed every every 4 hours for 24 hours (6 doses total).
1098810|NCT00564486|P2|Participant Flow|IV Acetaminophen 1 gm|IV Acetaminophen 1 gm dosed every every 6 hours for 24 hours (4 doses total).
1098811|NCT00564486|P1|Participant Flow|Intravenous (IV) Placebo (100 ml)|IV Placebo 100 ml dosed every every 6 hours for 24 hours (4 doses total).
1098812|NCT00564486|O3|Outcome|IV Acetaminophen 650 mg|IV Acetaminophen 650 mg every 4 hours for 24 hours (6 doses total)
1098813|NCT00564486|O2|Outcome|IV Acetaminophen 1 gm|IV Acetaminophen 1 gm every 6 hours for 24 hours (4 doses total)
1098815|NCT00564486|O3|Outcome|IV Acetaminophen 650 mg|IV Acetaminophen 650 mg every 4 hours for 24 hours
1098816|NCT00564486|O2|Outcome|IV Acetaminophen 1000 mg|IV Acetaminophen 1000 mg every 6 hours for 24 hours
1098817|NCT00564486|O1|Outcome|IV Placebo|IV Placebo 100 ml and IV placebo 65 ml groups combined
1098818|NCT00564486|O2|Outcome|IV Acetaminophen 650 mg|mITT - IV Acetaminophen 650 mg
1098819|NCT00564486|O1|Outcome|IV Placebo|mITT - IV Placebo 100 ml and IV placebo 65 ml groups combined
1098820|NCT00564486|O2|Outcome|IV Acetaminophen 1 gm|mITT - IV Acetaminophen 1 gm
1098821|NCT00564486|O1|Outcome|IV Placebo|mITT - IV Placebo 100 ml and IV placebo 65 ml groups combined
1098822|NCT00564486|E4|Reported Event|IV Placebo (65 ml)|IV Placebo 65 ml dosed every every 4 hours for 24 hours (6 doses total).
1098823|NCT00564486|E3|Reported Event|IV Acetaminophen 650 mg|IV Acetaminophen 650 mg dosed every every 4 hours for 24 hours (6 doses total).
1098824|NCT00564486|E2|Reported Event|IV Acetaminophen 1 gm|IV Acetaminophen 1 gm dosed every every 6 hours for 24 hours (4 doses total).
1098825|NCT00564486|E1|Reported Event|Intravenous (IV) Placebo (100 ml)|IV Placebo 100 ml dosed every every 6 hours for 24 hours (4 doses total).
1098826|NCT00564447|B9|Baseline|Total|Total of all reporting groups
1098827|NCT00564447|B8|Baseline|Moxifloxacin 0.5% Ophthalmic Solution-24 Hours Post Dose|
1098828|NCT00564447|B7|Baseline|Moxifloxacin 0.5% Ophthalmic Solution-12 Hours Post Dose|
1098829|NCT00564447|B6|Baseline|Moxifloxacin 0.5% Ophthalmic Solution-2 Hours Post Dose|
1098830|NCT00564447|B5|Baseline|Moxifloxacin 0.5% Ophthalmic Solution-30 Minutes Post Dose|
1098831|NCT00564447|B4|Baseline|Azithromycin Ophthalmic Solution, 1% -24 Hours Post Dose|
1098832|NCT00564447|B3|Baseline|Azithromycin Ophthalmic Solution, 1% -12 Hours Post Dose|
1098833|NCT00564447|B2|Baseline|Azithromycin Ophthalmic Solution, 1% -2 Hours Post Dose|
1098834|NCT00564447|B1|Baseline|Azithromycin Ophthalmic Solution, 1% -30 Minutes Post Dose|
1098835|NCT00564447|P8|Participant Flow|Moxifloxacin 0.5% Ophthalmic Solution-24 Hours Post Dose|
1098836|NCT00564447|P7|Participant Flow|Moxifloxacin 0.5% Ophthalmic Solution-12 Hours Post Dose|
1098837|NCT00564447|P6|Participant Flow|Moxifloxacin 0.5% Ophthalmic Solution-2 Hours Post Dose|
1098838|NCT00564447|P5|Participant Flow|Moxifloxacin 0.5% Ophthalmic Solution-30 Minutes Post Dose|
1098839|NCT00564447|P4|Participant Flow|Azithromycin Ophthalmic Solution, 1% -24 Hours Post Dose|
1098840|NCT00564447|P3|Participant Flow|Azithromycin Ophthalmic Solution, 1% -12 Hours Post Dose|
1098841|NCT00564447|P2|Participant Flow|Azithromycin Ophthalmic Solution, 1% -2 Hours Post Dose|
1098842|NCT00564447|P1|Participant Flow|Azithromycin Ophthalmic Solution, 1% -30 Minutes Post Dose|
1098843|NCT00564447|O8|Outcome|Moxifloxacin 0.5% Ophthalmic Solution-24 Hours Post Dose|
1098844|NCT00564447|O7|Outcome|Moxifloxacin 0.5% Ophthalmic Solution-12 Hours Post Dose|
1098845|NCT00564447|O6|Outcome|Moxifloxacin 0.5% Ophthalmic Solution-2 Hours Post Dose|
1098846|NCT00564447|O5|Outcome|Moxifloxacin 0.5% Ophthalmic Solution-30 Minutes Post Dose|
1098847|NCT00564447|O4|Outcome|Azithromycin Ophthalmic Solution, 1% -24 Hours Post Dose|
1098848|NCT00564447|O3|Outcome|Azithromycin Ophthalmic Solution, 1% -12 Hours Post Dose|
1098849|NCT00564447|O2|Outcome|Azithromycin Ophthalmic Solution, 1% -2 Hours Post Dose|
1098850|NCT00564447|O1|Outcome|Azithromycin Ophthalmic Solution, 1% -30 Minutes Post Dose|
1098851|NCT00564447|E8|Reported Event|Moxifloxacin 0.5% Ophthalmic Solution-24 Hours Post Dose|
1098852|NCT00564447|E7|Reported Event|Moxifloxacin 0.5% Ophthalmic Solution-12 Hours Post Dose|
1098853|NCT00564447|E6|Reported Event|Moxifloxacin 0.5% Ophthalmic Solution-2 Hours Post Dose|
1098854|NCT00564447|E5|Reported Event|Moxifloxacin 0.5% Ophthalmic Solution-30 Minutes Post Dose|
1098855|NCT00564447|E4|Reported Event|Azithromycin Ophthalmic Solution, 1% -24 Hours Post Dose|
1098856|NCT00564447|E3|Reported Event|Azithromycin Ophthalmic Solution, 1% -12 Hours Post Dose|
1098857|NCT00564447|E2|Reported Event|Azithromycin Ophthalmic Solution, 1% -2 Hours Post Dose|
1098858|NCT00564447|E1|Reported Event|Azithromycin Ophthalmic Solution, 1% -30 Minutes Post Dose|
1098859|NCT00564278|B3|Baseline|Total|Total of all reporting groups
1098860|NCT00564278|B2|Baseline|Motivational Pharmacotherapy|N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater. Mean age was 44.1 with SD=12.3.
1098861|NCT00564278|B1|Baseline|Standard Medication Therapy|N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater. Mean age was 43.4 with SD=13.2.
1098862|NCT00564278|P2|Participant Flow|Motivational Antidepressant Therapy|As per study criteria, the N=98 sample is our sample for data analysis. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline Hamilton Depression Scale-17 score of 16 or greater. Mean age was 44.1 (SD = 12.3).
1098863|NCT00564278|P1|Participant Flow|Standard Antidepressant Therapy|As per study criteria, the N=97 sample is our sample for data analysis. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline Hamilton Depression Scale-17 score of 16 or greater. Mean age was 43.41 (SD = 13.2).
1098864|NCT00564278|O2|Outcome|Motivational Antidepressant Therapy|N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
1098865|NCT00564278|O1|Outcome|Standard Antidepressant Therapy|N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
1099045|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1098866|NCT00564278|O2|Outcome|Motivational Antidepressant Therapy|N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
1098867|NCT00564278|O1|Outcome|Standard Antidepressant Therapy|N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
1098868|NCT00564278|O2|Outcome|Motivational Antidepressant Therapy|N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
1098869|NCT00564278|O1|Outcome|Standard Antidepressant Therapy|N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
1098870|NCT00564278|O2|Outcome|Motivational Antidepressant Therapy|N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
1098871|NCT00564278|O1|Outcome|Standard Antidepressant Therapy|N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
1098872|NCT00564278|O2|Outcome|Motivational Antidepressant Therapy|N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
1098873|NCT00564278|O1|Outcome|Standard Antidepressant Therapy|N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
1098874|NCT00564278|O2|Outcome|Motivational Antidepressant Therapy|N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
1098875|NCT00564278|O1|Outcome|Standard Antidepressant Therapy|N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
1098876|NCT00564278|E2|Reported Event|Motivational Antidepressant Therapy|Participants will receive motivational antidepressant therapy. Motivational antidepressant therapy (MADT): The same medication treatment for depression will be offered as in the SADT arm and supplemented with techniques from motivational interviewing.
1098877|NCT00564278|E1|Reported Event|Standard Antidepressant Therapy|Participants will receive standard antidepressant therapy. Standard antidepressant therapy (SADT): Treatment with medication will follow the Texas Medication Algorithm (TMA) for Depression. Antidepressant medications may include the following: citalopram (Celexa), escitalopram (Lexapro), paroxetine (Paxil CR), sertraline (Zoloft), venlafaxine XR (Effexor XR), bupropion SR (Wellbutrin SR), duloxetine (Cymbalta), nortriptyline (Pamelor), and mirtazapine (Remeron).
1098878|NCT00564265|B1|Baseline|Gastrointestinal Stromal Tumor (GIST)|GIST in all locations: Stomach, duodenum, jejunum, ileum, and rectum. All patients were submitted to surgery and in 2 cases are on Imatinib therapy.
1098879|NCT00564265|P1|Participant Flow|Gastrointestinal Stromal Tumor (GIST)|GIST in all locations: Stomach, duodenum, jejunum, ileum, and rectum. All patients were submitted to surgery and in 2 cases are on Imatinib therapy.
1099175|NCT00562627|O3|Outcome|Epidural|continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
1098880|NCT00564265|O1|Outcome|Gastrointestinal Stromal Tumor (GIST)|GIST in all locations: Stomach, duodenum, jejunum, ileum, and rectum. All patients were submitted to surgery and in 2 cases are on Imatinib therapy.
1098881|NCT00564265|E1|Reported Event|Gastrointestinal Stromal Tumor (GIST)|GIST in all locations: Stomach, duodenum, jejunum, ileum, and rectum. All patients were submitted to surgery and in 2 cases are on Imatinib therapy.
1098882|NCT00563797|B3|Baseline|Total|Total of all reporting groups
1098883|NCT00563797|B2|Baseline|Placebo|"Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.~Placebo: Placebo pill"
1098884|NCT00563797|B1|Baseline|Mecamylamine|"Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.~Mecamylamine: mecamylamine 10mg/day for 12 weeks"
1098885|NCT00563797|P2|Participant Flow|Placebo|"Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.~Placebo: Placebo pill"
1098886|NCT00563797|P1|Participant Flow|Mecamylamine|"Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.~Mecamylamine: mecamylamine 10mg/day for 12 weeks"
1098887|NCT00563797|O2|Outcome|Placebo|"Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.~Placebo: Placebo pill"
1098888|NCT00563797|O1|Outcome|Mecamylamine|"Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.~Mecamylamine: mecamylamine 10mg/day for 12 weeks"
1098889|NCT00563797|O2|Outcome|Placebo|"Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.~Placebo: Placebo pill"
1099047|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1098890|NCT00563797|O1|Outcome|Mecamylamine|"Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.~Mecamylamine: mecamylamine 10mg/day for 12 weeks"
1098891|NCT00563797|O2|Outcome|Placebo|"Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.~Placebo: Placebo pill"
1098892|NCT00563797|O1|Outcome|Mecamylamine|"Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.~Mecamylamine: mecamylamine 10mg/day for 12 weeks"
1098893|NCT00563797|O2|Outcome|Mecamylamine|"Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.~Mecamylamine: mecamylamine 10mg/day for 12 weeks"
1098894|NCT00563797|O1|Outcome|Placebo|"Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.~Placebo: Placebo pill"
1098895|NCT00563797|E2|Reported Event|Placebo|"Placebo capsules were prepared by the pharmacy and were identical in size and color to themedication capsules.~Placebo: Placebo pill"
1098896|NCT00563797|E1|Reported Event|Mecamylamine|"Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.~Mecamylamine: mecamylamine 10mg/day for 12 weeks"
1098897|NCT00563706|B10|Baseline|Total|Total of all reporting groups
1098898|NCT00563706|B9|Baseline|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
1098899|NCT00563706|B8|Baseline|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
1098900|NCT00563706|B7|Baseline|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
1098901|NCT00563706|B6|Baseline|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
1098902|NCT00563706|B5|Baseline|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
1098903|NCT00563706|B4|Baseline|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098904|NCT00563706|B3|Baseline|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098905|NCT00563706|B2|Baseline|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098906|NCT00563706|B1|Baseline|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098907|NCT00563706|P9|Participant Flow|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
1098908|NCT00563706|P8|Participant Flow|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
1098924|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1099046|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1098909|NCT00563706|P7|Participant Flow|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
1098910|NCT00563706|P6|Participant Flow|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
1098911|NCT00563706|P5|Participant Flow|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
1098912|NCT00563706|P4|Participant Flow|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098913|NCT00563706|P3|Participant Flow|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098914|NCT00563706|P2|Participant Flow|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098915|NCT00563706|P1|Participant Flow|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098916|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
1098917|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
1098918|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
1098919|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
1098987|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1099034|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1098920|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
1098921|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098922|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098923|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1099040|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1098925|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
1098926|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
1098927|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
1098928|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
1098929|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
1098930|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098931|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098932|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098933|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098934|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
1098935|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
1098936|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
1098937|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
1098938|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
1098939|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098940|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1099189|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
1098941|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098942|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098943|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
1098944|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
1098945|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
1098946|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
1098947|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
1098948|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098949|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098950|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098951|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098952|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
1098953|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
1098954|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
1098955|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
1098956|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
1099041|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1099042|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1098957|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098958|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098959|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098960|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098961|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
1098962|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
1098963|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
1098964|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
1098965|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
1098966|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098967|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098968|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098969|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098970|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
1098971|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
1098972|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
1098973|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
1098974|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
1098975|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098976|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098977|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098978|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098979|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
1098980|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
1098981|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
1098982|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
1098983|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
1098984|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098985|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098986|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1099033|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1098988|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
1098989|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
1098990|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
1099191|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
1098991|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
1098992|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
1098993|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098994|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098995|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098996|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1098997|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
1098998|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
1098999|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
1099000|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
1099001|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
1099002|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1099003|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1099226|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
1099004|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1099005|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1099006|NCT00563706|E9|Reported Event|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
1099043|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1099044|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1099007|NCT00563706|E8|Reported Event|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
1099008|NCT00563706|E7|Reported Event|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
1099009|NCT00563706|E6|Reported Event|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
1099010|NCT00563706|E5|Reported Event|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
1099011|NCT00563706|E4|Reported Event|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1099012|NCT00563706|E3|Reported Event|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1099013|NCT00563706|E2|Reported Event|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1099014|NCT00563706|E1|Reported Event|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
1099015|NCT00563576|B3|Baseline|Total|Total of all reporting groups
1099016|NCT00563576|B2|Baseline|Depot Medroxyprogesterone Acetate (DMPA) Alone|Subjects will receive Depo-Provera intramuscular injection.
1099017|NCT00563576|B1|Baseline|Femring|Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
1099018|NCT00563576|P2|Participant Flow|Depot Medroxyprogesterone Acetate (DMPA) Alone|Subjects will receive Depo-Provera intramuscular injection.
1099019|NCT00563576|P1|Participant Flow|Femring|Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
1099020|NCT00563576|O2|Outcome|Depot Medroxyprogesterone Acetate (DMPA) Alone|Subjects will receive Depo-Provera intramuscular injection.
1099021|NCT00563576|O1|Outcome|Femring|Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
1099022|NCT00563576|O2|Outcome|Depot Medroxyprogesterone Acetate (DMPA) Alone|Subjects will receive Depo-Provera intramuscular injection.
1099023|NCT00563576|O1|Outcome|Femring|Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
1099024|NCT00563576|O2|Outcome|Depot Medroxyprogesterone Acetate (DMPA) Alone|Subjects will receive Depo-Provera intramuscular injection.
1099025|NCT00563576|O1|Outcome|Femring|Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
1099026|NCT00563576|E2|Reported Event|Depot Medroxyprogesterone Acetate (DMPA) Alone|Subjects will receive Depo-Provera intramuscular injection.
1099027|NCT00563576|E1|Reported Event|Femring|Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
1099028|NCT00563381|B3|Baseline|Total|Total of all reporting groups
1099029|NCT00563381|B2|Baseline|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1099030|NCT00563381|B1|Baseline|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1099031|NCT00563381|P2|Participant Flow|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1099032|NCT00563381|P1|Participant Flow|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1099035|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1099036|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1099037|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1099038|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1099039|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1099315|NCT00562302|P1|Participant Flow|Bio-Seal Group|Bio-Seal Plug Implanted
1099048|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1099049|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1099050|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1099051|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1099052|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1099053|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1099054|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1099055|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1099056|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1099057|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1099058|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1099059|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1099060|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1099061|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1099062|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1099063|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1099064|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1099065|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1099066|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1099067|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1099068|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1099069|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1099070|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1099071|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1099072|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1099073|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1099074|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1099075|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1099076|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1099077|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1099078|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1099079|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1099080|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1099081|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1099082|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1099083|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1099084|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1099085|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1099086|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1099087|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1099088|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1099089|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1099090|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1099091|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1099092|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1099093|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1099094|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1099095|NCT00563381|E2|Reported Event|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
1099096|NCT00563381|E1|Reported Event|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
1099097|NCT00563368|B8|Baseline|Total|Total of all reporting groups
1099098|NCT00563368|B7|Baseline|VI-0521 Top|15 mg/92 mg phentermine/topiramate
1099099|NCT00563368|B6|Baseline|TPM 92 mg|92 mg topiramate
1099100|NCT00563368|B5|Baseline|PHEN 15 mg|15 mg phentermine
1099101|NCT00563368|B4|Baseline|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
1099102|NCT00563368|B3|Baseline|TPM 46 mg|46 mg topiramate
1099103|NCT00563368|B2|Baseline|PHEN 7.5 mg|7.5 mg phentermine
1099104|NCT00563368|B1|Baseline|Placebo|Placebo
1099105|NCT00563368|P7|Participant Flow|VI-0521 Top|15 mg/92 mg phentermine/topiramate
1099106|NCT00563368|P6|Participant Flow|TPM 92 mg|92 mg topiramate
1099107|NCT00563368|P5|Participant Flow|PHEN 15 mg|15 mg phentermine
1099108|NCT00563368|P4|Participant Flow|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
1099109|NCT00563368|P3|Participant Flow|TPM 46 mg|46 mg topiramate
1099110|NCT00563368|P2|Participant Flow|PHEN 7.5 mg|7.5 mg phentermine
1099111|NCT00563368|P1|Participant Flow|Placebo|Placebo
1099112|NCT00563368|O7|Outcome|VI-0521 Top|15 mg/92 mg phentermine/topiramate
1099113|NCT00563368|O6|Outcome|TPM 92 mg|92 mg topiramate
1099114|NCT00563368|O5|Outcome|PHEN 15 mg|15 mg phentermine
1099115|NCT00563368|O4|Outcome|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
1099116|NCT00563368|O3|Outcome|TPM 46 mg|46 mg topiramate
1099117|NCT00563368|O2|Outcome|PHEN 7.5 mg|7.5 mg phentermine
1099118|NCT00563368|O1|Outcome|Placebo|Placebo
1099119|NCT00563368|O7|Outcome|VI-0521 Top|15 mg/92 mg phentermine/topiramate
1099120|NCT00563368|O6|Outcome|TPM 92 mg|92 mg topiramate
1099121|NCT00563368|O5|Outcome|PHEN 15 mg|15 mg phentermine
1099122|NCT00563368|O4|Outcome|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
1099123|NCT00563368|O3|Outcome|TPM 46 mg|46 mg topiramate
1099124|NCT00563368|O2|Outcome|PHEN 7.5 mg|7.5 mg phentermine
1099125|NCT00563368|O1|Outcome|Placebo|Placebo
1099126|NCT00563368|E7|Reported Event|VI-0521 Top|15 mg/92 mg phentermine/topiramate
1099127|NCT00563368|E6|Reported Event|TPM 92 mg|92 mg topiramate
1099128|NCT00563368|E5|Reported Event|PHEN 15 mg|15 mg phentermine
1099129|NCT00563368|E4|Reported Event|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
1099130|NCT00563368|E3|Reported Event|TPM 46 mg|46 mg topiramate
1099131|NCT00563368|E2|Reported Event|PHEN 7.5 mg|7.5 mg phentermine
1099132|NCT00563368|E1|Reported Event|Placebo|Placebo
1099174|NCT00562627|O1|Outcome|LIA IV (Local Infiltration Analgesia, Intravenous)|Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine
1099133|NCT00563316|B1|Baseline|Panitumumab + Irinotecan|Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
1099134|NCT00563316|P1|Participant Flow|Panitumumab + Irinotecan|Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
1099135|NCT00563316|O5|Outcome|Treatment Phase 4|All Other – 72 hours after administration of irinotecan in Cycle 2 until end of study.
1099136|NCT00563316|O4|Outcome|Treatment Phase 3|Cycle 2 Irinotecan and Panitumumab – After irinotecan administration until 72 hours after administration.
1099137|NCT00563316|O3|Outcome|Treatment Phase 2|Cycle 1 Irinotecan and Panitumumab – After first panitumumab administration until the start of Cycle 2.
1099138|NCT00563316|O2|Outcome|Treatment Phase 1|Cycle 1 Irinotecan – After irinotecan administration, but before panitumumab administration.
1099139|NCT00563316|O1|Outcome|Panitumumab + Irinotecan|Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
1099140|NCT00563316|O1|Outcome|Panitumumab + Irinotecan|Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
1099141|NCT00563316|O1|Outcome|Panitumumab + Irinotecan|Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
1099142|NCT00563316|O1|Outcome|Panitumumab + Irinotecan|Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
1099190|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
1099143|NCT00563316|E1|Reported Event|Panitumumab With Irinotecan|Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
1099144|NCT00563290|B3|Baseline|Total|Total of all reporting groups
1099145|NCT00563290|B2|Baseline|Arm II Dastinib|Patients receive oral dasatinib 70 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1099146|NCT00563290|B1|Baseline|Arm I Dasatinib|Patients receive oral dasatinib 100 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1099147|NCT00563290|P2|Participant Flow|Arm II Dasatinib|Patients receive 70 mg dasatinib PO BID on days 1-28
1099148|NCT00563290|P1|Participant Flow|Arm I Dasatinib|Patients receive 100 mg orally twice a day.
1099149|NCT00563290|O1|Outcome|Dasatinib|Patients receive 100 mg orally twice a day. Due to a dosing update the dose was decreased to 70 mg orally twice a day.
1099150|NCT00563290|O1|Outcome|Dasatinib|Patients receive 100 mg orally twice a day. Due to a dosing update the dose was decreased to 70 mg orally twice a day.
1099151|NCT00563290|O1|Outcome|Arm I and Arm II|"For Arm I patients receive Dasatinib100 mg orally twice a day.~For Arm II patients receive Dasatinib 70 mg orally twice a day."
1099152|NCT00563290|O2|Outcome|Arm II: Dasatinib|Patients receive 70 mg orally twice a day.
1099153|NCT00563290|O1|Outcome|Arm I: Dasatinib|Patients receive 100 mg orally twice a day.
1099154|NCT00563290|E2|Reported Event|Dasatinib 70 mg|Patients receive the initial dose of 70 mg orally twice a day. Dose was reduced to 70 mg orally based on toxicity.
1099155|NCT00563290|E1|Reported Event|Dasatinib 100 mg|Patients receive the initial dose of 100 mg orally twice a day.
1099156|NCT00562861|B3|Baseline|Total|Total of all reporting groups
1099157|NCT00562861|B2|Baseline|Mood Stabilizer Plus Placebo|Placebo plus mood stabilizer: subjects receive placebo, added to standard mood stabilizers
1099158|NCT00562861|B1|Baseline|Mood Stabilizer Plus Citalopram|citalopram + mood stabilizer: Subjects receive the active drug, added to standard mood stabilizers.
1099159|NCT00562861|P2|Participant Flow|Mood Stabilizer Plus Placebo|Mood stabilizer alone will be the treatment, with placebo used instead of double-blind citalopram.
1099160|NCT00562861|P1|Participant Flow|Mood Stabilizer Plus Citalopram|citalopram + mood stabilizer: Citalopram dose will be flexibly designed, beginning at 10 mg/d for at least one week, and the increased by 10 mg per week to a maximum of 50 mg/d.
1099161|NCT00562861|O2|Outcome|Placebo|Mood stabilizers given as part of standard treatment plus double-blind placebo
1099162|NCT00562861|O1|Outcome|Citalopram|Mood stabilizers given as part of standard treatment plus double-blind citalopram
1099163|NCT00562861|E2|Reported Event|Placebo|Mood stabilizers given as part of standard treatment plus double-blind placebo
1099164|NCT00562861|E1|Reported Event|Citalopram|Mood stabilizers given as part of standard treatment plus double-blind citalopram
1099165|NCT00562627|B4|Baseline|Total|Total of all reporting groups
1099166|NCT00562627|B3|Baseline|Epidural|continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
1099167|NCT00562627|B2|Baseline|LIA IA, (Local Infiltration Analgesia, Intra-articular)|Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine
1099168|NCT00562627|B1|Baseline|LIA IV (Local Infiltration Analgesia, Intravenous)|Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine
1099169|NCT00562627|P3|Participant Flow|Epidural|continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
1099170|NCT00562627|P2|Participant Flow|LIA IA, (Local Infiltration Analgesia, Intra-articular)|Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine
1099171|NCT00562627|P1|Participant Flow|LIA IV (Local Infiltration Analgesia, Intravenous)|Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine
1099172|NCT00562627|O3|Outcome|Epidural|continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
1099173|NCT00562627|O2|Outcome|LIA IA, (Local Infiltration Analgesia, Intra-articular)|Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine
1099676|NCT00561678|O1|Outcome|Precedex|Precedex (Dexmedetomidine) 0.5/ug/kg/hr
1099176|NCT00562627|O2|Outcome|LIA IA, (Local Infiltration Analgesia, Intra-articular)|Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine
1099177|NCT00562627|O1|Outcome|LIA IV (Local Infiltration Analgesia, Intravenous)|Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine
1099178|NCT00562627|O3|Outcome|Epidural|continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
1099179|NCT00562627|O2|Outcome|LIA IA, (Local Infiltration Analgesia, Intra-articular)|Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine
1099180|NCT00562627|O1|Outcome|LIA IV (Local Infiltration Analgesia, Intravenous)|Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine
1099181|NCT00562627|E3|Reported Event|Epidural|continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
1099182|NCT00562627|E2|Reported Event|LIA IA, (Local Infiltration Analgesia, Intra-articular)|Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine
1099183|NCT00562627|E1|Reported Event|LIA IV (Local Infiltration Analgesia, Intravenous)|Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine
1099184|NCT00562588|B3|Baseline|Total|Total of all reporting groups
1099185|NCT00562588|B2|Baseline|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
1099186|NCT00562588|B1|Baseline|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
1099187|NCT00562588|P2|Participant Flow|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
1099188|NCT00562588|P1|Participant Flow|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
1099192|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
1099193|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
1099194|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
1099195|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
1099196|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
1099197|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
1099198|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
1099199|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
1099200|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
1099201|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
1099202|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
1099203|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
1099204|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
1099205|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
1099206|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
1099207|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
1099208|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
1099209|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
1099210|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
1099211|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
1099212|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
1099213|NCT00562588|E2|Reported Event|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
1099214|NCT00562588|E1|Reported Event|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
1099215|NCT00562484|B3|Baseline|Total|Total of all reporting groups
1099216|NCT00562484|B2|Baseline|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
1099217|NCT00562484|B1|Baseline|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
1099218|NCT00562484|P2|Participant Flow|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
1099219|NCT00562484|P1|Participant Flow|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
1099220|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
1099221|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
1099222|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
1099223|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
1099224|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
1099225|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
1099227|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
1099228|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
1099229|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
1099230|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
1099231|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
1099232|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
1099233|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
1099234|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
1099235|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
1099236|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
1099237|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
1099238|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
1099239|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
1099240|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
1099241|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
1099242|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
1099243|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
1099244|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
1099245|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
1099246|NCT00562484|E2|Reported Event|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
1099247|NCT00562484|E1|Reported Event|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
1099248|NCT00562354|B3|Baseline|Total|Total of all reporting groups
1099249|NCT00562354|B2|Baseline|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
1099250|NCT00562354|B1|Baseline|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
1099251|NCT00562354|P2|Participant Flow|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
1099252|NCT00562354|P1|Participant Flow|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
1099253|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
1099254|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age.
1099255|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
1099256|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
1099257|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age.
1099258|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
1099259|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
1099260|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
1099261|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
1099262|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
1099263|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
1099264|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
1099265|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
1099266|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
1099267|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
1099268|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
1099269|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
1099473|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
1099270|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
1099271|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
1099272|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
1099273|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
1099274|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
1099275|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
1099276|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
1099277|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
1099278|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
1099279|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
1099280|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
1099281|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
1099282|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
1099283|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
1099284|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
1099285|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
1099286|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
1099287|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
1099288|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
1099289|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
1099290|NCT00562354|E2|Reported Event|13vPnC (≥65 Years of Age)|"13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.~For Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=77; systematic (solicited) Local Reactions N=118; systematic (solicited) Systemic Events N=116. Serious AEs were grouped by organ system, with frequency of events summarized. Non-serious AEs were summarized in a similar manner and include unsolicited AEs collected in the e-diary (systematic assessment) and solicited events collected on the case report form (non-systematic methods)."
1099291|NCT00562354|E1|Reported Event|13vPnC (50 to 64 Years of Age)|"13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.~For Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=80; systematic (solicited) Local Reactions N=120; systematic (solicited) Systemic Events N=112. Serious AEs were grouped by organ system, with frequency of events summarized. Non-serious AEs were summarized in a similar manner and include unsolicited AEs collected in the e-diary (systematic assessment) and solicited events collected on the case report form (non-systematic methods)."
1099292|NCT00562328|B1|Baseline|Alemtuzumab + Rituximab + GM-CSF|Alemtuzumab + Rituximab + GM-CSF
1099293|NCT00562328|P1|Participant Flow|Alemtuzumab + Rituximab + GM-CSF|Alemtuzumab + Rituximab + GM-CSF
1099294|NCT00562328|O1|Outcome|Alemtuzumab + Rituximab + GM-CSF|Alemtuzumab + Rituximab + GM-CSF
1099295|NCT00562328|E1|Reported Event|Alemtuzumab + Rituximab + GM-CSF|Alemtuzumab + Rituximab + GM-CSF
1099296|NCT00562315|B1|Baseline|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
1099297|NCT00562315|P1|Participant Flow|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
1099298|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
1099299|NCT00562315|O1|Outcome|FACBC PET/CT for Recurrent Prostate Cancer|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
1099300|NCT00562315|O1|Outcome|FACBC PET/CT for Recurrent Prostate Cancer|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
1099301|NCT00562315|O1|Outcome|FACBC PET/CT for Recurrent Prostate Cancer|"This is a single arm study~[18F]FACBC: [18F]FACBC is given intravenously prior to PET scan"
1099670|NCT00561678|P1|Participant Flow|Precedex|Precedex (Dexmedetomidine) 0.5/ug/kg/hr
1099302|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
1099303|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
1099304|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
1099305|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
1099306|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
1099307|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
1099308|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
1099309|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
1099310|NCT00562315|E1|Reported Event|FACBC PET-CT and ProstaScint CT|All participants who received scans, including repeat scans, were monitored for adverse events.
1099311|NCT00562302|B3|Baseline|Total|Total of all reporting groups
1099312|NCT00562302|B2|Baseline|Control Group|Control group with no intervention
1099313|NCT00562302|B1|Baseline|Bio-Seal Group|Bio-Seal Plug Implanted
1099314|NCT00562302|P2|Participant Flow|Control Group|Control group with no intervention
1099316|NCT00562302|O2|Outcome|Control Group|Control group with no intervention
1099317|NCT00562302|O1|Outcome|Bio-Seal Group|Bio-Seal Plug Implanted
1099318|NCT00562302|O2|Outcome|Control Group|Control group with no intervention
1099319|NCT00562302|O1|Outcome|Bio-Seal Group|Bio-Seal Plug Implanted
1099320|NCT00562302|O2|Outcome|Control Group|Control group with no intervention
1099321|NCT00562302|O1|Outcome|Bio-Seal Group|Bio-Seal Plug Implanted
1099322|NCT00562302|O2|Outcome|Control Group|Control group with no intervention
1099323|NCT00562302|O1|Outcome|Bio-Seal Group|Bio-Seal Plug Implanted
1099324|NCT00562302|O2|Outcome|Control Group|Control group with no intervention
1099325|NCT00562302|O1|Outcome|Bio-Seal Group|Bio-Seal Plug Implanted
1099326|NCT00562302|O2|Outcome|Control Group|Control group with no intervention
1099327|NCT00562302|O1|Outcome|Bio-Seal Group|Bio-Seal Plug Implanted
1099328|NCT00562302|O2|Outcome|Control Group|Control group with no intervention
1099329|NCT00562302|O1|Outcome|Bio-Seal Group|Bio-Seal Plug Implanted
1099330|NCT00562302|O2|Outcome|Control Group|Control group with no intervention
1099331|NCT00562302|O1|Outcome|Bio-Seal Group|Bio-Seal Plug Implanted
1099332|NCT00562302|E2|Reported Event|Control Group|Control group with no intervention
1099333|NCT00562302|E1|Reported Event|Bio-Seal Group|Bio-Seal Plug Implanted
1099334|NCT00562159|B3|Baseline|Total|Total of all reporting groups
1099335|NCT00562159|B2|Baseline|Placebo|Rapidly dissolving matching placebo tablets administered sublingually once daily.
1099336|NCT00562159|B1|Baseline|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
1099337|NCT00562159|P2|Participant Flow|Placebo|Rapidly dissolving matching placebo tablets administered sublingually once daily.
1099338|NCT00562159|P1|Participant Flow|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
1099339|NCT00562159|O2|Outcome|Placebo|Rapidly dissolving matching placebo tablets administered sublingually once daily.
1099340|NCT00562159|O1|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
1099341|NCT00562159|O2|Outcome|Placebo|Rapidly dissolving matching placebo tablets administered sublingually once daily.
1099342|NCT00562159|O1|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
1099343|NCT00562159|O2|Outcome|Placebo|Rapidly dissolving matching placebo tablet administered sublingually once daily.
1099344|NCT00562159|O1|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
1099345|NCT00562159|O2|Outcome|Placebo|Rapidly dissolving matching placebo tablet administered sublingually once daily.
1099346|NCT00562159|O1|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
1099347|NCT00562159|E2|Reported Event|Placebo|Rapidly dissolving matching placebo tablets administered sublingually once daily.
1099348|NCT00562159|E1|Reported Event|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
1099349|NCT00562120|B1|Baseline|Entire Study Population|All participants randomized to any treatment (PF-03654746 10 mg capsule first, PF-03654746 1 mg capsule first, Allegra-D tablet-in-capsule first and placebo first).
1099372|NCT00562120|O4|Outcome|Placebo|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
1099373|NCT00562120|O3|Outcome|Allegra-D|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
1099374|NCT00562120|O2|Outcome|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
1099671|NCT00561678|O2|Outcome|Placebo|Placebo - normal saline 0.5/ug/kg/hr
1099350|NCT00562120|P4|Participant Flow|Placebo, Allegra-D, PF-03654746 10 mg, PF-03654746 1 mg|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the first intervention period; followed by placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period.
1099351|NCT00562120|P3|Participant Flow|Allegra-D, PF-03654746 1 mg, Placebo, PF-03654746 10 mg|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the first intervention period; followed by PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period.
1099352|NCT00562120|P2|Participant Flow|PF-03654746 1 mg, PF-03654746 10 mg, Allegra-D, Placebo|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the first intervention period; followed by PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule and Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period.
1099388|NCT00562094|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
1105680|NCT00549601|B4|Baseline|Total|Total of all reporting groups
1099353|NCT00562120|P1|Participant Flow|PF-03654746 10 mg, Placebo, PF-03654746 1 mg, Allegra-D|PF-03654746 10 milligram (mg) capsule and Allegra (fexofenadine 60 mg) tablet-in-capsule along with placebo matched to Allegra-D (fexofenadine 60 mg in combination with pseudoephedrine 120 mg) tablet-in-capsule on Day 1 in the first intervention period; followed by placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period.
1099354|NCT00562120|O2|Outcome|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
1099355|NCT00562120|O1|Outcome|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
1099356|NCT00562120|O4|Outcome|Placebo|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
1099357|NCT00562120|O3|Outcome|Allegra-D|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
1099358|NCT00562120|O2|Outcome|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
1099359|NCT00562120|O1|Outcome|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
1099360|NCT00562120|O4|Outcome|Placebo|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
1099361|NCT00562120|O3|Outcome|Allegra-D|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
1099362|NCT00562120|O2|Outcome|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
1099363|NCT00562120|O1|Outcome|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
1099364|NCT00562120|O4|Outcome|Placebo|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
1099365|NCT00562120|O3|Outcome|Allegra-D|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
1099366|NCT00562120|O2|Outcome|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
1099367|NCT00562120|O1|Outcome|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
1099368|NCT00562120|O4|Outcome|Placebo|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
1099369|NCT00562120|O3|Outcome|Allegra-D|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
1099370|NCT00562120|O2|Outcome|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
1099371|NCT00562120|O1|Outcome|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
1099375|NCT00562120|O1|Outcome|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
1099376|NCT00562120|O4|Outcome|Placebo|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
1099377|NCT00562120|O3|Outcome|Allegra-D|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
1099378|NCT00562120|O2|Outcome|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
1099379|NCT00562120|O1|Outcome|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
1099380|NCT00562120|E4|Reported Event|Placebo|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
1099381|NCT00562120|E3|Reported Event|Allegra-D|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
1099382|NCT00562120|E2|Reported Event|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
1099383|NCT00562120|E1|Reported Event|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
1099384|NCT00562094|B1|Baseline|Pantoprazole|All patients enrolled
1099385|NCT00562094|P1|Participant Flow|Pantoprazole|All patients enrolled
1099386|NCT00562094|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
1099387|NCT00562094|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
1099389|NCT00562094|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
1099390|NCT00562094|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
1099391|NCT00562094|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
1099392|NCT00562094|O1|Outcome|Pantoprazole|All patients with valid values ('as observed')
1099393|NCT00562094|O2|Outcome|Pantoprazole / End of Therapy|All patients with valid values ('as observed')
1099394|NCT00562094|O1|Outcome|Pantoprazole / Start of Therapy|All patients with valid values ('as observed')
1099395|NCT00562094|E1|Reported Event|Pantoprazole|Patients included and treated with at least one application of pantoprazole
1099396|NCT00561977|B4|Baseline|Total|Total of all reporting groups
1099397|NCT00561977|B3|Baseline|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
1099398|NCT00561977|B2|Baseline|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
1099399|NCT00561977|B1|Baseline|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
1099400|NCT00561977|P3|Participant Flow|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
1099401|NCT00561977|P2|Participant Flow|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
1099402|NCT00561977|P1|Participant Flow|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
1099403|NCT00561977|O3|Outcome|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
1099404|NCT00561977|O2|Outcome|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
1099405|NCT00561977|O1|Outcome|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
1099406|NCT00561977|O3|Outcome|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
1099407|NCT00561977|O2|Outcome|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
1099408|NCT00561977|O1|Outcome|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
1099409|NCT00561977|O3|Outcome|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
1099410|NCT00561977|O2|Outcome|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
1099411|NCT00561977|O1|Outcome|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
1099412|NCT00561977|O3|Outcome|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
1099413|NCT00561977|O2|Outcome|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
1099414|NCT00561977|O1|Outcome|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
1099415|NCT00561977|O3|Outcome|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
1099416|NCT00561977|O2|Outcome|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
1099672|NCT00561678|O1|Outcome|Precedex|Precedex (Dexmedetomidine) 0.5/ug/kg/hr
1099417|NCT00561977|O1|Outcome|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
1099418|NCT00561977|O3|Outcome|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
1099419|NCT00561977|O2|Outcome|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
1099420|NCT00561977|O1|Outcome|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
1099421|NCT00561977|E3|Reported Event|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
1099422|NCT00561977|E2|Reported Event|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
1099423|NCT00561977|E1|Reported Event|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
1099424|NCT00561951|B4|Baseline|Total|Total of all reporting groups
1099425|NCT00561951|B3|Baseline|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
1099426|NCT00561951|B2|Baseline|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
1099427|NCT00561951|B1|Baseline|Placebo|Subjects were treated with placebo once daily for 12 weeks.
1099428|NCT00561951|P3|Participant Flow|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
1099429|NCT00561951|P2|Participant Flow|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
1099430|NCT00561951|P1|Participant Flow|Placebo|Subjects were treated with placebo once daily for 12 weeks.
1099431|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
1099432|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
1099433|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
1099434|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
1099435|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
1099436|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
1099437|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
1099438|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
1099439|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
1099440|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
1099441|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
1099442|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
1099443|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
1099444|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
1099445|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
1099446|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
1099447|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
1099448|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
1099449|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
1099450|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
1099451|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
1099452|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
1099453|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
1099454|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
1099455|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
1099456|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
1099457|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
1099458|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
1099459|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
1099460|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
1099461|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
1099462|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
1099463|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
1099464|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
1099465|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
1099466|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
1099467|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
1099468|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
1099469|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
1099470|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
1099471|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
1099472|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
1099474|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
1099475|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
1099476|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
1099477|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
1099478|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
1099479|NCT00561951|E3|Reported Event|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
1099480|NCT00561951|E2|Reported Event|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
1099481|NCT00561951|E1|Reported Event|Placebo|Subjects were treated with placebo once daily for 12 weeks.
1099482|NCT00561925|B4|Baseline|Total|Total of all reporting groups
1099483|NCT00561925|B3|Baseline|NVP XR 400mg QD|Nevirapine extended release 400 mg tablets given once daily
1099484|NCT00561925|B2|Baseline|NVP IR 200mg BID|Nevirapine immediate release 200 mg tablets given twice daily
1099485|NCT00561925|B1|Baseline|NVP IR 200mg QD|Nevirapine immediate release 200 mg tablets given once daily
1099486|NCT00561925|P5|Participant Flow|NVP IR to XR|
1099487|NCT00561925|P4|Participant Flow|NVP XR|
1099488|NCT00561925|P3|Participant Flow|NVP XR 400mg QD|Nevirapine extended release 400 mg given once daily
1099489|NCT00561925|P2|Participant Flow|NVP IR 200mg BID|Nevirapine immediate release 200 mg given twice daily
1099490|NCT00561925|P1|Participant Flow|NVP IR 200mg QD|Nevirapine immediate release 200 mg given once daily
1099491|NCT00561925|O4|Outcome|XR-IR/XR|Patients receiving nevirapine XR during open label extension who had previously received nevirapine IR during the pre week 144
1099492|NCT00561925|O3|Outcome|IR-IR/XR|Patients receiving nevirapine IR during the 144 week blinded phase and then receiving nevirapine XR in the post week 144 of extension
1099493|NCT00561925|O2|Outcome|NVP XR|Patients receiving nevirapine XR during the 144 week blinded phase and nevirapine XR during open label extension
1099545|NCT00561834|E1|Reported Event|Ranibizumab|ranibizumab: 0.5mg ranibizumab given intravitreally as needed after initial treatment
1099494|NCT00561925|O1|Outcome|NVP IR|Patients received nevirapine IR during the 144 week blinded phase but who never took nevirapine XR during the open label extension
1099495|NCT00561925|O2|Outcome|NVP XR|Nevirapine extended release 400 mg tablets given once daily
1099496|NCT00561925|O1|Outcome|NVP IR|Nevirapine immediate release 200 mg tablets given twice daily
1099497|NCT00561925|O2|Outcome|NVP XR|Nevirapine extended release 400 mg tablets given once daily
1099498|NCT00561925|O1|Outcome|NVP IR|Nevirapine immediate release 200 mg tablets given twice daily
1099499|NCT00561925|O2|Outcome|NVP XR|Nevirapine extended release 400 mg tablets given once daily
1099500|NCT00561925|O1|Outcome|NVP IR|Nevirapine immediate release 200 mg tablets given twice daily
1099501|NCT00561925|O2|Outcome|NVP XR|Nevirapine extended release 400 mg tablets given once daily
1099502|NCT00561925|O1|Outcome|NVP IR|Nevirapine immediate release 200 mg tablets given twice daily
1099503|NCT00561925|O2|Outcome|NVP XR|Nevirapine extended release 400 mg tablets given once daily
1099504|NCT00561925|O1|Outcome|NVP IR|Nevirapine immediate release 200 mg tablets given twice daily
1099505|NCT00561925|O2|Outcome|NVP XR|Nevirapine extended release 400 mg tablets given once daily
1099506|NCT00561925|O1|Outcome|NVP IR|Nevirapine immediate release 200 mg tablets given twice daily
1099507|NCT00561925|O4|Outcome|XR-IR/XR|Patients receiving nevirapine XR during open label extension and previously receiving nevirapine IR during the pre week 144
1099508|NCT00561925|O3|Outcome|IR-IR/XR|Patients receiving nevirapine IR during the 144 week blinded phase and then receiving nevirapine XR in the post week 144 of extension
1099509|NCT00561925|O2|Outcome|NVP XR|Patients receiving nevirapine XR during the 144 week blinded phase and nevirapine XR during open label extension
1099510|NCT00561925|O1|Outcome|NVP IR|Patients received nevirapine IR during the 144 week blinded phase and nevirapine XR during open label extension
1099511|NCT00561925|O4|Outcome|XR-IR/XR|Patients receiving nevirapine XR during open label extension and previously receiving nevirapine IR during the pre week 144
1099512|NCT00561925|O3|Outcome|IR-IR/XR|Patients receiving nevirapine IR during the 144 week blinded phase and then receiving nevirapine XR in the post week 144 of extension
1099513|NCT00561925|O2|Outcome|NVP XR|Patients receiving nevirapine XR during the 144 week blinded phase and nevirapine XR during open label extension
1099514|NCT00561925|O1|Outcome|NVP IR|Patients received nevirapine IR during the 144 week blinded phase and nevirapine XR during open label extension
1099515|NCT00561925|O3|Outcome|NVP XR 400mg QD|Nevirapine extended release 400 mg tablets given once daily
1099516|NCT00561925|O2|Outcome|NVP IR 200mg BID|Nevirapine immediate release 200 mg tablets given twice daily
1099517|NCT00561925|O1|Outcome|NVP IR 200mg QD|Nevirapine immediate release 200 mg tablets given once daily
1099518|NCT00561925|O3|Outcome|NVP XR 400mg QD|Nevirapine extended release 400 mg tablets given once daily
1099519|NCT00561925|O2|Outcome|NVP IR 200mg BID|Nevirapine immediate release 200 mg tablets given twice daily
1099520|NCT00561925|O1|Outcome|NVP IR 200mg QD|Nevirapine immediate release 200 mg tablets given once daily
1099521|NCT00561925|O3|Outcome|NVP XR 400mg QD|Nevirapine extended release 400 mg tablets given once daily
1099522|NCT00561925|O2|Outcome|NVP IR 200mg BID|Nevirapine immediate release 200 mg tablets given twice daily
1099523|NCT00561925|O1|Outcome|NVP IR 200mg QD|Nevirapine immediate release 200 mg tablets given once daily
1099524|NCT00561925|O3|Outcome|NVP XR 400mg QD|Nevirapine extended release 400 mg tablets given once daily
1099525|NCT00561925|O2|Outcome|NVP IR 200mg BID|Nevirapine immediate release 200 mg tablets given twice daily
1099526|NCT00561925|O1|Outcome|NVP IR 200mg QD|Nevirapine immediate release 200 mg tablets given once daily
1099527|NCT00561925|O3|Outcome|NVP XR 400mg QD|Nevirapine extended release 400 mg tablets given once daily
1099528|NCT00561925|O2|Outcome|NVP IR 200mg BID|Nevirapine immediate release 200 mg tablets given twice daily
1099529|NCT00561925|O1|Outcome|NVP IR 200mg QD|Nevirapine immediate release 200 mg tablets given once daily
1099530|NCT00561925|O3|Outcome|NVP XR 400mg QD|Nevirapine extended release 400 mg tablets given once daily
1099531|NCT00561925|O2|Outcome|NVP IR 200mg BID|Nevirapine immediate release 200 mg tablets given twice daily
1099532|NCT00561925|O1|Outcome|NVP IR 200mg QD|Nevirapine immediate release 200 mg tablets given once daily
1099533|NCT00561925|E5|Reported Event|NVP XR-IR/XR|Patients receiving nevirapine XR during open label extension who had previously receiving nevirapine IR during the pre week 144
1099534|NCT00561925|E4|Reported Event|NVP IR-IR/XR|Patients receiving nevirapine IR during the 144 week blinded phase and then receiving nevirapine XR in the post week 144 of extension
1099535|NCT00561925|E3|Reported Event|NVP XR|Patients receiving nevirapine XR during the 144 week blinded phase and nevirapine XR during open label extension
1099536|NCT00561925|E2|Reported Event|NVP IR|Patients received nevirapine IR during the 144 week blinded phase but who never took nevirapine XR during the open label extension
1099537|NCT00561925|E1|Reported Event|NVP IR 200mg QD|Nevirapine immediate release 200 mg given once daily
1099538|NCT00561912|B1|Baseline|Decitabine + Interferon Alfa-2b|Decitabine 15 mg/m^2 intravenous (IV) daily over one hour for 5 days + Interferon Alfa-2b 0.5 million Units Subcutaneously Twice Daily Continuously, as of Cycle 3, Day 1.
1099539|NCT00561912|P1|Participant Flow|Decitabine + Interferon Alfa-2b|Decitabine 15 mg/m^2 intravenous (IV) daily over one hour for 5 days + Interferon Alfa-2b 0.5 million Units Subcutaneously Twice Daily Continuously, as of Cycle 3, Day 1.
1099540|NCT00561912|O1|Outcome|Decitabine + Interferon Alfa-2b|Decitabine 15 mg/m^2 intravenous (IV) daily over one hour for 5 days + Interferon Alfa-2b 0.5 million Units Subcutaneously Twice Daily Continuously, as of Cycle 3, Day 1.
1099541|NCT00561912|E1|Reported Event|Decitabine + Interferon Alfa-2b|Decitabine 15 mg/m^2 intravenous (IV) daily over one hour for 5 days + Interferon Alfa-2b 0.5 million Units Subcutaneously Twice Daily Continuously, as of Cycle 3, Day 1.
1099542|NCT00561834|B1|Baseline|Ranibizumab|ranibizumab: 0.5mg ranibizumab given intravitreally as needed after initial treatment
1099543|NCT00561834|P1|Participant Flow|Ranibizumab|ranibizumab: 0.5mg ranibizumab given intravitreally as needed after initial treatment
1099544|NCT00561834|O1|Outcome|Ranibizumab|ranibizumab: 0.5mg ranibizumab given intravitreally as needed after initial treatment
1099547|NCT00561821|B4|Baseline|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
1099548|NCT00561821|B3|Baseline|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099549|NCT00561821|B2|Baseline|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099550|NCT00561821|B1|Baseline|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099551|NCT00561821|P4|Participant Flow|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
1099552|NCT00561821|P3|Participant Flow|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099553|NCT00561821|P2|Participant Flow|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099554|NCT00561821|P1|Participant Flow|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099555|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
1099556|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099557|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099558|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099559|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
1099560|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099561|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099562|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099563|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
1099564|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099565|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099673|NCT00561678|O2|Outcome|Placebo|Placebo - normal saline 0.5/ug/kg/hr
1099674|NCT00561678|O1|Outcome|Precedex|Precedex (Dexmedetomidine) 0.5/ug/kg/hr
1099566|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099567|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
1099568|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099569|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099570|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099571|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
1099572|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099573|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099574|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099575|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
1099576|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099577|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099578|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099579|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
1099580|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099581|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099582|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099583|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
1099584|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099585|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099586|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099587|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
1099588|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099589|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099590|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099591|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
1099592|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099593|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099594|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099595|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
1099596|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099597|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099598|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099599|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
1099600|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099601|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099602|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099603|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
1099604|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099605|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099606|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099607|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
1099608|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099609|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099610|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099611|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
1099612|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099613|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099614|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099615|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
1099616|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099617|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099618|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099619|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
1099620|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099621|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099622|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099623|NCT00561821|E4|Reported Event|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
1099624|NCT00561821|E3|Reported Event|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099625|NCT00561821|E2|Reported Event|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099626|NCT00561821|E1|Reported Event|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
1099627|NCT00561795|B3|Baseline|Total|Total of all reporting groups
1099628|NCT00561795|B2|Baseline|A5-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
1099629|NCT00561795|B1|Baseline|A5-1|Paclitaxel 175 milligrams (mg)/square meter (m^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
1099630|NCT00561795|P4|Participant Flow|A6-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
1099631|NCT00561795|P3|Participant Flow|A6-1|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
1099632|NCT00561795|P2|Participant Flow|A5-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
1099633|NCT00561795|P1|Participant Flow|A5-1|Paclitaxel 175 milligrams (mg)/square meter (m^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
1099634|NCT00561795|O4|Outcome|A6-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
1099635|NCT00561795|O3|Outcome|A6-1|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
1099636|NCT00561795|O2|Outcome|A5-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
1099637|NCT00561795|O1|Outcome|A5-1|Paclitaxel 175 milligrams (mg)/square meter (m^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
1099638|NCT00561795|O4|Outcome|A6-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
1099639|NCT00561795|O3|Outcome|A6-1|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
1099640|NCT00561795|O2|Outcome|A5-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
1099707|NCT00561600|B2|Baseline|Pinnacle MoM|Pinnacle metal on metal acetabular cup system
1099641|NCT00561795|O1|Outcome|A5-1|Paclitaxel 175 milligrams (mg)/square meter (m^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
1099642|NCT00561795|O4|Outcome|A6-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
1099643|NCT00561795|O3|Outcome|A6-1|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
1099644|NCT00561795|O2|Outcome|A5-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
1099645|NCT00561795|O1|Outcome|A5-1|Paclitaxel 175 milligrams (mg)/square meter (m^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
1099646|NCT00561795|O4|Outcome|A6-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
1099647|NCT00561795|O3|Outcome|A6-1|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
1099648|NCT00561795|O2|Outcome|A5-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
1099649|NCT00561795|O1|Outcome|A5-1|Paclitaxel 175 milligrams (mg)/square meter (m^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
1099650|NCT00561795|E2|Reported Event|A5-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
1099651|NCT00561795|E1|Reported Event|A5-1|Paclitaxel 175 milligrams (mg)/square meter (m^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
1099652|NCT00561730|B1|Baseline|Pantoprazole|All patients enrolled
1099653|NCT00561730|P1|Participant Flow|Pantoprazole|All patients enrolled
1099654|NCT00561730|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
1099655|NCT00561730|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
1099656|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
1099657|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
1099658|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
1099659|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
1099660|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
1099661|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
1099662|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
1099663|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
1099664|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
1099665|NCT00561730|E1|Reported Event|Pantoprazole|Patients included and treated with at least one application of pantoprazole
1099666|NCT00561678|B3|Baseline|Total|Total of all reporting groups
1099667|NCT00561678|B2|Baseline|Placebo|Placebo - normal saline 0.5/ug/kg/hr
1099668|NCT00561678|B1|Baseline|Precedex|Precedex (Dexmedetomidine) 0.5/ug/kg/hr
1099669|NCT00561678|P2|Participant Flow|Placebo|Placebo - normal saline 0.5/ug/kg/hr
1099678|NCT00561678|O1|Outcome|Precedex|Precedex (Dexmedetomidine) 0.5/ug/kg/hr
1099679|NCT00561678|O2|Outcome|Placebo|Placebo - normal saline 0.5/ug/kg/hr
1099680|NCT00561678|O1|Outcome|Precedex|Precedex (Dexmedetomidine) 0.5/ug/kg/hr
1099681|NCT00561678|O2|Outcome|Placebo|Placebo - normal saline 0.5/ug/kg/hr
1099682|NCT00561678|O1|Outcome|Precedex|Precedex (Dexmedetomidine) 0.5/ug/kg/hr
1099683|NCT00561678|E2|Reported Event|Placebo|Placebo - normal saline 0.5/ug/kg/hr
1099684|NCT00561678|E1|Reported Event|Precedex|Precedex (Dexmedetomidine) 0.5/ug/kg/hr
1099685|NCT00561652|B3|Baseline|Total|Total of all reporting groups
1099686|NCT00561652|B2|Baseline|Arm 2|Chiropractic treatment plus Education plus exercise
1099687|NCT00561652|B1|Baseline|Arm 1|Education plus exercise
1099688|NCT00561652|P2|Participant Flow|Arm 2|Chiropractic treatment plus education plus exercise
1099689|NCT00561652|P1|Participant Flow|Arm 1|Education plus exercise
1099690|NCT00561652|O2|Outcome|Arm 2|Chiropractic treatment plus education plus exercise
1099691|NCT00561652|O1|Outcome|Arm 1|Education plus exercise
1099692|NCT00561652|O2|Outcome|Arm 2|Chiropractic treatment plus education plus exercise
1099693|NCT00561652|O1|Outcome|Arm 1|Education plus exercise
1099694|NCT00561652|O2|Outcome|Arm 2|Chiropractic treatment plus education plus exercise
1099695|NCT00561652|O1|Outcome|Arm 1|Education plus exercise
1099696|NCT00561652|O2|Outcome|Arm 2|Chiropractic treatment plus education plus exercise
1099697|NCT00561652|O1|Outcome|Arm 1|Education plus exercise
1099698|NCT00561652|O2|Outcome|Arm 2|Chiropractic treatment plus education plus exercise
1099699|NCT00561652|O1|Outcome|Arm 1|Education plus exercise
1099700|NCT00561652|O2|Outcome|Arm 2|Chiropractic treatment plus education plus exercise
1099701|NCT00561652|O1|Outcome|Arm 1|Education plus exercise
1099702|NCT00561652|O2|Outcome|Arm 2|Chiropractic treatment plus education plus exercise
1099703|NCT00561652|O1|Outcome|Arm 1|Education plus exercise
1099704|NCT00561652|E2|Reported Event|Arm 2|Chiropractic treatment plus education plus exercise
1099705|NCT00561652|E1|Reported Event|Arm 1|Education plus exercise
1099709|NCT00561600|P2|Participant Flow|B Pinnacle™|Pinnacle™ acetabular shell, with a 28mm or 36mm ULTAMET® metal liner, and a 28mm or 36mm Articul/eze M head.
1099710|NCT00561600|P1|Participant Flow|A ASR™-XL|ASR™-XL Modular Acetabular Cup System stem
1099711|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
1099712|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
1099713|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
1099714|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
1099715|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
1099716|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
1099717|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
1099718|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
1099719|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
1099720|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
1099721|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
1099722|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
1099723|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
1099724|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
1099725|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
1099726|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
1099727|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
1099728|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
1099729|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
1099730|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
1099731|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
1099732|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
1099733|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
1099734|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
1099735|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
1099736|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
1099737|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
1099738|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
1099739|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
1099740|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
1099741|NCT00561600|O2|Outcome|Pinnacle MoM|Pinnacle metal on metal acetabular cup system
1099742|NCT00561600|O1|Outcome|ASR XL|ASR™-XL Acetabular Cup System
1099743|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
1099744|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
1099745|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
1099746|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
1099747|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
1099748|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
1099749|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
1099750|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
1099751|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
1099752|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
1099753|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
1099754|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
1099755|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
1099756|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
1099757|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
1099758|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
1099759|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
1099769|NCT00561574|B3|Baseline|Total|Total of all reporting groups
1099770|NCT00561574|B2|Baseline|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
1099771|NCT00561574|B1|Baseline|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
1099772|NCT00561574|P2|Participant Flow|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
1099773|NCT00561574|P1|Participant Flow|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
1099774|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
1099775|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
1099776|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
1099777|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
1099778|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
1099779|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
1099780|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
1099781|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
1099782|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
1099783|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
1099784|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
1099785|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
1101118|NCT00558571|O3|Outcome|25mg Empagliflozin|oral administration in the fasted state once daily.
1099786|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
1099787|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
1099788|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
1099789|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
1099790|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
1099791|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
1099792|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
1099793|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
1099794|NCT00561574|E2|Reported Event|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
1099795|NCT00561574|E1|Reported Event|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
1099796|NCT00561470|B3|Baseline|Total|Total of all reporting groups
1099797|NCT00561470|B2|Baseline|Aflibercept/Folfiri|Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept and FOLFIRI (Irinotecan, 5- Fluorouracil, and Leucovorin)
1099798|NCT00561470|B1|Baseline|Placebo/Folfiri|Participants with Metastatic Colorectal Cancer administered Placebo and FOLFIRI (Irinotecan, 5- Fluorouracil, and Leucovorin)
1099799|NCT00561470|P2|Participant Flow|Aflibercept/FOLFIRI|Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
1099800|NCT00561470|P1|Participant Flow|Placebo/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
1099801|NCT00561470|O2|Outcome|Aflibercept/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Aflibercept and FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
1099802|NCT00561470|O1|Outcome|Placebo/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Placebo and FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
1099803|NCT00561470|O2|Outcome|Aflibercept/FOLFIRI|Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
1099804|NCT00561470|O1|Outcome|Placebo/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
1099805|NCT00561470|O2|Outcome|Aflibercept/FOLFIRI|Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
1099806|NCT00561470|O1|Outcome|Placebo/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
1099807|NCT00561470|O2|Outcome|Aflibercept/FOLFIRI|Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
1099808|NCT00561470|O1|Outcome|Placebo/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
1099809|NCT00561470|O2|Outcome|Aflibercept/FOLFIRI|Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
1099810|NCT00561470|O1|Outcome|Placebo/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
1099811|NCT00561470|E2|Reported Event|Aflibercept/FOLFIRI|Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
1099812|NCT00561470|E1|Reported Event|Placebo/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
1099813|NCT00561457|B1|Baseline|Luminexx Iliac Stent and Delivery System|Bard® LUMINEXX* Iliac Stent and the Bard® LUMINEXX* 6F Iliac Stent systems.
1099814|NCT00561457|P1|Participant Flow|Luminexx Iliac Stent and Delivery System|Bard® LUMINEXX* Iliac Stent and the Bard® LUMINEXX* 6F Iliac Stent systems.
1099815|NCT00561457|O1|Outcome|Luminexx Iliac Stent and Delivery System|Bard® LUMINEXX* Iliac Stent and the Bard® LUMINEXX* 6F Iliac Stent systems.
1099816|NCT00561457|E1|Reported Event|Luminexx Iliac Stent and Delivery System|Bard® LUMINEXX* Iliac Stent and the Bard® LUMINEXX* 6F Iliac Stent systems.
1099817|NCT00561431|B3|Baseline|Total|Total of all reporting groups
1099818|NCT00561431|B2|Baseline|High Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr
1099819|NCT00561431|B1|Baseline|Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr
1099820|NCT00561431|P2|Participant Flow|High Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr
1099821|NCT00561431|P1|Participant Flow|Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr
1099822|NCT00561431|O2|Outcome|High Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr
1099823|NCT00561431|O1|Outcome|Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr
1099824|NCT00561431|O2|Outcome|High Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr
1101119|NCT00558571|O2|Outcome|10mg Empagliflozin|oral administration in the fasted state once daily.
1099825|NCT00561431|O1|Outcome|Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr
1099826|NCT00561431|E2|Reported Event|High Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr
1099827|NCT00561431|E1|Reported Event|Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr
1099828|NCT00561418|B1|Baseline|Vorinostat (SAHA)|"Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations.~vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.~Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)"
1099829|NCT00561418|P1|Participant Flow|Vorinostat (SAHA)|"Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations.~vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.~Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post Hematopoietic Stem Cell Transplantation),days +56 to +66 (≈2 mos), and at Cycle 2 Day 1 (≈3 mos.), Cycle 3 Day 1 (≈4 mos.), Cycle 5 Day 1 (≈6 mos.),Cycle 7 Day 1 (≈8 mos.), and off study (ideally at ≈12 mos.)"
1099830|NCT00561418|O1|Outcome|Vorinostat (SAHA)|"Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations.~vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.~Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)"
1099831|NCT00561418|O1|Outcome|Vorinostat (SAHA)|"Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations.~vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.~Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)"
1099832|NCT00561418|O1|Outcome|Vorinostat (SAHA)|"Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations.~vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.~Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)"
1099854|NCT00561353|B4|Baseline|TMC435 200 mg (Cohort 2)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
1100163|NCT00560950|O1|Outcome|1st Revaccination Group Day 1|
1100164|NCT00560950|O4|Outcome|2nd Revaccination Group Day 30|
1099833|NCT00561418|O1|Outcome|Vorinostat (SAHA)|"Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations.~vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.~Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)"
1099834|NCT00561418|E1|Reported Event|Vorinostat (SAHA)|"Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations.~vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.~Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)"
1099835|NCT00561392|B1|Baseline|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
1099836|NCT00561392|P1|Participant Flow|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
1099837|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
1099838|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
1099839|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
1099840|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
1099841|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
1099842|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
1099843|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
1099844|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
1099845|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
1099846|NCT00561392|E1|Reported Event|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
1099847|NCT00561353|B11|Baseline|Total|Total of all reporting groups
1099848|NCT00561353|B10|Baseline|TMC435 200 mg (Cohort 5)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099849|NCT00561353|B9|Baseline|Placebo (Cohort 4)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099850|NCT00561353|B8|Baseline|TMC435 200 mg (Cohort 4)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099851|NCT00561353|B7|Baseline|TMC435 150 mg (Cohort 4)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099852|NCT00561353|B6|Baseline|TMC435 75 mg (Cohort 4)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099853|NCT00561353|B5|Baseline|Placebo (Cohort 2)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
1100165|NCT00560950|O3|Outcome|2nd Revaccination Group Day 1|
1099855|NCT00561353|B3|Baseline|Placebo (Cohort 1)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
1099856|NCT00561353|B2|Baseline|TMC435 75mg (Cohort 1)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
1099857|NCT00561353|B1|Baseline|TMC435 25 mg (Cohort 1)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
1099858|NCT00561353|P10|Participant Flow|TMC435 200 mg (Cohort 5/Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099859|NCT00561353|P9|Participant Flow|Placebo (Cohort 4/Panel C)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099860|NCT00561353|P8|Participant Flow|TMC435 200 mg (Cohort 4/Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099861|NCT00561353|P7|Participant Flow|TMC435 150 mg (Cohort 4/Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099862|NCT00561353|P6|Participant Flow|TMC435 75 mg (Cohort 4/Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099863|NCT00561353|P5|Participant Flow|Placebo (Cohort 2/Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
1101120|NCT00558571|O1|Outcome|Placebo|oral administration in the fasted state once daily.
1099864|NCT00561353|P4|Participant Flow|TMC435 200 mg (Cohort 2, Panel A and B)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
1099865|NCT00561353|P3|Participant Flow|Placebo (Cohort 1/Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
1099866|NCT00561353|P2|Participant Flow|TMC435 75mg (Cohort 1/Panel A and B)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
1099867|NCT00561353|P1|Participant Flow|TMC435 25 mg (Cohort 1/Panel A and B)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
1099868|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099869|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099870|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099871|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
1099872|NCT00561353|O6|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099873|NCT00561353|O5|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily for 28 days coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099874|NCT00561353|O4|Outcome|TMC435 25 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099875|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
1099876|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
1099877|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22.
1099878|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099879|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099880|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1100166|NCT00560950|O2|Outcome|1st Revaccination Group Day 30|
1099881|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
1099882|NCT00561353|O6|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099883|NCT00561353|O5|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily for 28 days coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099884|NCT00561353|O4|Outcome|TMC435 25 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099885|NCT00561353|O3|Outcome|TTMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
1099886|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
1099887|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22.
1099888|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099889|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099890|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099891|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
1101121|NCT00558571|O4|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
1099892|NCT00561353|O6|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099893|NCT00561353|O5|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily for 28 days coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099894|NCT00561353|O4|Outcome|TMC435 25 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099895|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
1099896|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
1099897|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22.
1099898|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099899|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099900|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099901|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon (PegIFNα-2a) on Days 1, 8, 15, and 22.
1099902|NCT00561353|O6|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099903|NCT00561353|O5|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099904|NCT00561353|O4|Outcome|TMC435 25 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099905|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
1099906|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
1099907|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22.
1099908|NCT00561353|O5|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099909|NCT00561353|O4|Outcome|Placebo (TMC435 75/150/200 mg) (Cohort 4, Panel C)|Treatment-experienced non-responders received Placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099910|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099911|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1100167|NCT00560950|O1|Outcome|1st Revaccination Group Day 1|
1099912|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
1099913|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
1099914|NCT00561353|O4|Outcome|TMC435 200mg (Cohort 2, Panel A and B)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
1099915|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed by Placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
1099916|NCT00561353|O2|Outcome|TMC435 75mg (Cohort 1, Panel A and B)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
1099917|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A and B)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
1099918|NCT00561353|O5|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers in Cohort 5, Panel D received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099943|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099919|NCT00561353|O4|Outcome|Placebo (TMC435 75/150/200 mg) (Cohort 4, Panel C)|Treatment-experienced non-responders received Placebo identical in appearance to TMC435 75 mg, 150 mg, or 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099920|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099921|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099922|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
1099923|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
1099924|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel A and B)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
1099925|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed by Placebo once daily coadministered with RBV for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
1099926|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A and B)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
1099927|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A and B)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
1099928|NCT00561353|O5|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099929|NCT00561353|O4|Outcome|Placebo (TMC435 75/150/200 mg) (Cohort 4, Panel C)|Treatment-experienced non-responders received Placebo identical in appearance to TMC435 75 mg, 150 mg, or 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099930|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099931|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099932|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
1099933|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panels A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
1099934|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panels A and B)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
1100168|NCT00560950|O4|Outcome|2nd Revaccination Group Day 30|
1100169|NCT00560950|O3|Outcome|2nd Revaccination Group Day 1|
1099935|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panels A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
1099936|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panels A and B)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
1099937|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panels A and B)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
1099938|NCT00561353|O5|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099939|NCT00561353|O4|Outcome|Placebo (Cohort 4, Panel C)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099940|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099941|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099942|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
1105850|NCT00549939|O3|Outcome|Alfuzosin 0.2 mg/kg/Day|
1099944|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099945|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099946|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily for 28 days coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099947|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
1099948|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel A)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
1099949|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
1099950|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel A)|Treatment-naïve participants received placebo identical in appearance toTMC435 25 or 75 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
1099951|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
1099952|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22.
1099953|NCT00561353|O5|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099954|NCT00561353|O4|Outcome|Placebo (Cohort 4, Panel C)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099955|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099956|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099957|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
1099958|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
1099959|NCT00561353|O4|Outcome|TMC435 200mg (Cohort 2, Panel A and B)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
1099960|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
1099990|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel A)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 or 75 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
1099961|NCT00561353|O2|Outcome|TMC435 75mg (Cohort 1, Panel A and B)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
1099962|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A and B)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
1099963|NCT00561353|O5|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099964|NCT00561353|O4|Outcome|Placebo (Cohort 4, Panel C)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099965|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099966|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099967|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
1099968|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099969|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1101122|NCT00558571|O3|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
1099970|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg and 75 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099971|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099972|NCT00561353|O1|Outcome|TMC435 25 (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
1099973|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel A)|Treatment-naïve participants in received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
1099974|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
1099975|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel A)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 or 75 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
1099976|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
1099977|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22.
1099978|NCT00561353|O5|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099979|NCT00561353|O4|Outcome|Placebo (Cohort 4, Panel C)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099980|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099981|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099982|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
1099983|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099984|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily for 28 days coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099985|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099986|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099987|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
1099988|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel A)|Treatment-naïve participants in received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
1099989|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
1099991|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
1099992|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22.
1099993|NCT00561353|O5|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099994|NCT00561353|O4|Outcome|Placebo (Cohort 4, Panel C)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099995|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099996|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099997|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
1099998|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1099999|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1100000|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1100001|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1100002|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
1100003|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel A)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
1100004|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
1100005|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel A)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 or 75 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
1100006|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
1100007|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22.
1100008|NCT00561353|E11|Reported Event|All TMC435 (All Cohorts)|
1100009|NCT00561353|E10|Reported Event|TMC435 200 mg (Cohort 5/Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1100010|NCT00561353|E9|Reported Event|Placebo (Cohort 4/Panel C)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1100011|NCT00561353|E8|Reported Event|TMC435 200 mg (Cohort 4/Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1100012|NCT00561353|E7|Reported Event|TMC435 150 mg (Cohort 4/Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1100013|NCT00561353|E6|Reported Event|TMC435 75 mg (Cohort 4/Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
1100014|NCT00561353|E5|Reported Event|Placebo (Cohort 2/Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
1100015|NCT00561353|E4|Reported Event|TMC435 200 mg (Cohort 2, Panel A and B)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
1100016|NCT00561353|E3|Reported Event|Placebo (Cohort 1/Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
1100017|NCT00561353|E2|Reported Event|TMC435 75mg (Cohort 1/Panel A and B)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
1100140|NCT00560950|B2|Baseline|2nd Revaccination Group|Received 1st revaccination with Pneumovax 23 during the initial phase and 2nd revaccination in the extension phase
1100170|NCT00560950|O2|Outcome|1st Revaccination Group Day 30|
1100171|NCT00560950|O1|Outcome|1st Revaccination Group Day 1|
1100018|NCT00561353|E1|Reported Event|TMC435 25 mg (Cohort 1/Panel A and B)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
1100019|NCT00561340|B3|Baseline|Total|Total of all reporting groups
1100020|NCT00561340|B2|Baseline|Counseling by the Provider on Ways to Encourage Caloric Intake|"Behavioral intervention - Nutritional Counseling~Nutritional counseling: 50% randomized to nutritional counseling only"
1100021|NCT00561340|B1|Baseline|1 Can of Pediasure Supplement Plus Nutritional Counseling|"Pediasure and nutritional counseling~Pediasure: 50% will be randomized to pediasure with nutritional counseling"
1100022|NCT00561340|P2|Participant Flow|Counseling by the Provider on Ways to Encourage Caloric Intake|"Behavioral intervention - Nutritional Counseling~Nutritional counseling: 50% randomized to nutritional counseling only"
1100023|NCT00561340|P1|Participant Flow|1 Can of Pediasure Supplement Plus Nutritional Counseling|"Pediasure and nutritional counseling~Pediasure: 50% will be randomized to pediasure with nutritional counseling"
1100024|NCT00561340|O2|Outcome|Counseling by the Provider on Ways to Encourage Caloric Intake|"Behavioral intervention - Nutritional Counseling~Nutritional counseling: 50% randomized to nutritional counseling only"
1100025|NCT00561340|O1|Outcome|1 Can of Pediasure Supplement Plus Nutritional Counseling|"Pediasure and nutritional counseling~Pediasure: 50% will be randomized to pediasure with nutritional counseling"
1100026|NCT00561340|O2|Outcome|Counseling by the Provider on Ways to Encourage Caloric Intake|"Behavioral intervention - Nutritional Counseling~Nutritional counseling: 50% randomized to nutritional counseling only"
1100027|NCT00561340|O1|Outcome|1 Can of Pediasure Supplement Plus Nutritional Counseling|"Pediasure and nutritional counseling~Pediasure: 50% will be randomized to pediasure with nutritional counseling"
1100028|NCT00561340|E2|Reported Event|Counseling by the Provider on Ways to Encourage Caloric Intake|"Behavioral intervention - Nutritional Counseling~Nutritional counseling: 50% randomized to nutritional counseling only"
1100029|NCT00561340|E1|Reported Event|1 Can of Pediasure Supplement Plus Nutritional Counseling|"Pediasure and nutritional counseling~Pediasure: 50% will be randomized to pediasure with nutritional counseling"
1100030|NCT00561145|B3|Baseline|Total|Total of all reporting groups
1100031|NCT00561145|B2|Baseline|Elderly Men|Elderly men: 65-85 years of age
1100032|NCT00561145|B1|Baseline|Young Men|Young men: 20-40 years of age
1100033|NCT00561145|P2|Participant Flow|Elderly Men|"Elderly men should be 65-85 years of age. Men will be excluded based on the following exclusion criteria:~body mass index (BMI in kg/m2) less than 20 or higher than 30, adherence to a weight-reduction or medically prescribed diet, dementia (Mini-Mental State Examination score\21), diabetes, anemia, gastrointestinal disorders, use of drugs known to interfere with energy balance, or a history of medical or surgical events known to affect the study outcome."
1100034|NCT00561145|P1|Participant Flow|Young Men|"Young men should be 20-40 years of age. Men will be excluded based on the following exclusion criteria:~body mass index (BMI in kg/m2) less than 20 or higher than 30, adherence to a weight-reduction or medically prescribed diet, dementia (Mini-Mental State Examination score\21), diabetes, anemia, gastrointestinal disorders, use of drugs known to interfere with energy balance, or a history of medical or surgical events known to affect the study outcome."
1100035|NCT00561145|O2|Outcome|Elderly Men|Elderly men: 65-85 years of age
1100036|NCT00561145|O1|Outcome|Young Men|Young men: 20-40 years of age
1100037|NCT00561145|E2|Reported Event|Elderly Men|Elderly men: 65-85 years of age
1100038|NCT00561145|E1|Reported Event|Young Men|Young men: 20-40 years of age
1100039|NCT00561015|B7|Baseline|Total|Total of all reporting groups
1100040|NCT00561015|B6|Baseline|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100041|NCT00561015|B5|Baseline|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100042|NCT00561015|B4|Baseline|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
1100043|NCT00561015|B3|Baseline|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100044|NCT00561015|B2|Baseline|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100172|NCT00560950|O4|Outcome|2nd Revaccination Group Day 30|
1100173|NCT00560950|O3|Outcome|2nd Revaccination Group Day 1|
1100045|NCT00561015|B1|Baseline|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
1100046|NCT00561015|P6|Participant Flow|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100047|NCT00561015|P5|Participant Flow|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100048|NCT00561015|P4|Participant Flow|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
1105851|NCT00549939|O2|Outcome|Alfuzosin 0.1 mg/kg/Day|
1100049|NCT00561015|P3|Participant Flow|Pbo With Peg-IFN-alfa-2a+ RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100050|NCT00561015|P2|Participant Flow|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100051|NCT00561015|P1|Participant Flow|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis (inflammation of liver) C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
1100052|NCT00561015|O6|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100053|NCT00561015|O5|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100054|NCT00561015|O4|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
1100055|NCT00561015|O3|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100056|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100141|NCT00560950|B1|Baseline|1st Revaccination Group|Received primary vaccination with Pneumovax 23 during the initial phase and 1st revaccination in the extension phase
1100174|NCT00560950|O2|Outcome|1st Revaccination Group Day 30|
1100175|NCT00560950|O1|Outcome|1st Revaccination Group Day 1|
1100057|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
1100058|NCT00561015|O6|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100059|NCT00561015|O5|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100060|NCT00561015|O4|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
1100061|NCT00561015|O3|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100062|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100063|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
1100064|NCT00561015|O6|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100065|NCT00561015|O5|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100066|NCT00561015|O4|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
1100067|NCT00561015|O3|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100068|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100142|NCT00560950|P2|Participant Flow|2nd Revaccination Group|Received 1st revaccination with Pneumovax 23 during the initial phase and 2nd revaccination in the extension phase
1100143|NCT00560950|P1|Participant Flow|1st Revaccination Group|Received primary vaccination with Pneumovax 23 during the initial phase and 1st revaccination in the extension phase
1100069|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
1100070|NCT00561015|O6|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100071|NCT00561015|O5|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100072|NCT00561015|O4|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
1105852|NCT00549939|O1|Outcome|Placebo|
1100073|NCT00561015|O3|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100074|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100075|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
1100076|NCT00561015|O6|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100077|NCT00561015|O5|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100078|NCT00561015|O4|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
1100079|NCT00561015|O3|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100080|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100144|NCT00560950|O4|Outcome|2nd Revaccination Group Day 30|
1100145|NCT00560950|O3|Outcome|2nd Revaccination Group Day 1|
1100146|NCT00560950|O2|Outcome|1st Revaccination Group Day 30|
1100147|NCT00560950|O1|Outcome|1st Revaccination Group Day 1|
1100148|NCT00560950|O4|Outcome|2nd Revaccination Group Day 30|
1100081|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
1100082|NCT00561015|O4|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100083|NCT00561015|O3|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
1100084|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100085|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
1100086|NCT00561015|O4|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100087|NCT00561015|O3|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
1100088|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100089|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
1100090|NCT00561015|O4|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100091|NCT00561015|O3|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
1100092|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100149|NCT00560950|O3|Outcome|2nd Revaccination Group Day 1|
1100150|NCT00560950|O2|Outcome|1st Revaccination Group Day 30|
1100151|NCT00560950|O1|Outcome|1st Revaccination Group Day 1|
1100152|NCT00560950|O4|Outcome|2nd Revaccination Group Day 30|
1100093|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
1100094|NCT00561015|O6|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100095|NCT00561015|O5|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100096|NCT00561015|O4|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
1100097|NCT00561015|O3|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100098|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100099|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
1100100|NCT00561015|O4|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100101|NCT00561015|O3|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
1100102|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100103|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
1100104|NCT00561015|O4|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100153|NCT00560950|O3|Outcome|2nd Revaccination Group Day 1|
1100154|NCT00560950|O2|Outcome|1st Revaccination Group Day 30|
1100155|NCT00560950|O1|Outcome|1st Revaccination Group Day 1|
1100156|NCT00560950|O4|Outcome|2nd Revaccination Group Day 30|
1100105|NCT00561015|O3|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
1100106|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100107|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
1100108|NCT00561015|O4|Outcome|TVR With Peg-IFN-alfa-2a on + RBV (T2/PR24) - Genotype 3|Participants who were never treated for CHC genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100109|NCT00561015|O3|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
1100110|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100111|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
1100112|NCT00561015|O6|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100113|NCT00561015|O5|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100114|NCT00561015|O4|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
1100115|NCT00561015|O3|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100116|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100157|NCT00560950|O3|Outcome|2nd Revaccination Group Day 1|
1100158|NCT00560950|O2|Outcome|1st Revaccination Group Day 30|
1100159|NCT00560950|O1|Outcome|1st Revaccination Group Day 1|
1100160|NCT00560950|O4|Outcome|2nd Revaccination Group Day 30|
1100161|NCT00560950|O3|Outcome|2nd Revaccination Group Day 1|
1100117|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
1100118|NCT00561015|E6|Reported Event|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100119|NCT00561015|E5|Reported Event|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100186|NCT00560937|O1|Outcome|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then~Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then~Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
1100187|NCT00560937|O2|Outcome|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
1101123|NCT00558571|O2|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
1100120|NCT00561015|E4|Reported Event|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
1100121|NCT00561015|E3|Reported Event|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100122|NCT00561015|E2|Reported Event|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
1100123|NCT00561015|E1|Reported Event|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
1100124|NCT00561002|B3|Baseline|Total|Total of all reporting groups
1100125|NCT00561002|B2|Baseline|Influenza Vaccine Primed|Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
1100126|NCT00561002|B1|Baseline|Influenza Vaccine Naive/Inadequately Primed|Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
1100127|NCT00561002|P2|Participant Flow|Influenza Vaccine Primed|Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
1100128|NCT00561002|P1|Participant Flow|Influenza Vaccine Naive/Inadequately Primed|Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
1100129|NCT00561002|O2|Outcome|Influenza Vaccine Primed|Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
1100130|NCT00561002|O1|Outcome|Influenza Vaccine Naive/Inadequately Primed|Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
1100131|NCT00561002|O2|Outcome|Influenza Vaccine Primed|Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
1100132|NCT00561002|O1|Outcome|Influenza Vaccine Naive/Inadequately Primed|Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
1100133|NCT00561002|O2|Outcome|Influenza Vaccine Primed|Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
1100134|NCT00561002|O1|Outcome|Influenza Vaccine Naive/Inadequately Primed|Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
1100135|NCT00561002|O2|Outcome|Influenza Vaccine Primed|Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
1100136|NCT00561002|O1|Outcome|Influenza Vaccine Naive/Inadequately Primed|Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
1100137|NCT00561002|E2|Reported Event|Influenza Vaccine Primed|Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
1100138|NCT00561002|E1|Reported Event|Influenza Vaccine Naive/Inadequately Primed|Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
1100139|NCT00560950|B3|Baseline|Total|Total of all reporting groups
1100162|NCT00560950|O2|Outcome|1st Revaccination Group Day 30|
1100176|NCT00560950|E2|Reported Event|2nd Revaccination Group|Received 1st revaccination with Pneumovax 23 during the initial phase and 2nd revaccination in the extension phase
1100177|NCT00560950|E1|Reported Event|1st Revaccination Group|Received primary vaccination with Pneumovax 23 during the initial phase and 1st revaccination in the extension phase
1100178|NCT00560937|B3|Baseline|Total|Total of all reporting groups
1100179|NCT00560937|B2|Baseline|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
1100180|NCT00560937|B1|Baseline|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then~Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then~Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
1100181|NCT00560937|P2|Participant Flow|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
1100182|NCT00560937|P1|Participant Flow|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then~Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then~Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
1100183|NCT00560937|O2|Outcome|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
1100184|NCT00560937|O1|Outcome|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then~Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then~Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
1100185|NCT00560937|O2|Outcome|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
1101124|NCT00558571|O1|Outcome|Placebo|Oral administration in the fasted state once daily.
1100188|NCT00560937|O1|Outcome|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then~Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then~Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
1100189|NCT00560937|O2|Outcome|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
1100190|NCT00560937|O1|Outcome|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then~Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then~Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
1100191|NCT00560937|O2|Outcome|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
1100192|NCT00560937|O1|Outcome|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then~Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then~Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
1100193|NCT00560937|O2|Outcome|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
1100194|NCT00560937|O1|Outcome|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then~Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then~Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
1100195|NCT00560937|E2|Reported Event|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
1100196|NCT00560937|E1|Reported Event|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then~Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then~Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
1100197|NCT00560885|B1|Baseline|AtriCure Bipolar System|"The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.~AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System"
1100198|NCT00560885|P1|Participant Flow|AtriCure Bipolar System|"The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.~AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System"
1100199|NCT00560885|O1|Outcome|AtriCure Bipolar System|"The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.~AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System"
1100200|NCT00560885|O1|Outcome|AtriCure Bipolar System|"The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.~AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System"
1100201|NCT00560885|O1|Outcome|AtriCure Bipolar System|"The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.~AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System"
1100202|NCT00560885|O1|Outcome|AtriCure Bipolar System|"The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.~AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System"
1100203|NCT00560885|E1|Reported Event|AtriCure Bipolar System|"The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.~AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System"
1100204|NCT00560859|B3|Baseline|Total|Total of all reporting groups
1100205|NCT00560859|B2|Baseline|Watchful Waiting|"Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.~Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period."
1100206|NCT00560859|B1|Baseline|Early AT Surgery|"Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.~Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome."
1100207|NCT00560859|P2|Participant Flow|Watchful Waiting|"Children will be closely monitored during the primary 7 month monitoring period and will be re-evaluated for AT by an otolaryngologist at the end of that period. a~Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period."
1100208|NCT00560859|P1|Participant Flow|Early AT Surgery|"Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.~Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome."
1101251|NCT00558428|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg|
1100209|NCT00560859|O2|Outcome|Watchful Waiting|"Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.~Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period."
1100210|NCT00560859|O1|Outcome|Early AT Surgery|"Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.~Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome."
1100211|NCT00560859|O2|Outcome|Watchful Waiting|"Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.~Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period."
1100212|NCT00560859|O1|Outcome|Early AT Surgery|"Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.~Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome."
1100213|NCT00560859|O2|Outcome|Watchful Waiting|"Children will be closely monitored during the primary 7-month monitoring period and re-evaluated for AT by an otolaryngologist after that period.~Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period."
1100214|NCT00560859|O1|Outcome|Early AT Surgery|"Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.~Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome."
1100400|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
1100215|NCT00560859|E2|Reported Event|Watchful Waiting|"Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.~Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period."
1100216|NCT00560859|E1|Reported Event|Early AT Surgery|"Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.~Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome."
1100217|NCT00560833|B6|Baseline|Total|Total of all reporting groups
1100218|NCT00560833|B5|Baseline|Esmertazapine 18 mg|Participants receive esmertazapine 18 mg, encapsulated tablet, PO, QD for up to 12 weeks
1100219|NCT00560833|B4|Baseline|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
1100220|NCT00560833|B3|Baseline|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
1100221|NCT00560833|B2|Baseline|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
1100222|NCT00560833|B1|Baseline|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
1100223|NCT00560833|P5|Participant Flow|Esmirtazapine 18mg|Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks
1100224|NCT00560833|P4|Participant Flow|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
1100225|NCT00560833|P3|Participant Flow|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
1100226|NCT00560833|P2|Participant Flow|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
1100227|NCT00560833|P1|Participant Flow|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
1100228|NCT00560833|O5|Outcome|Esmirtazapine 18mg|Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks
1100229|NCT00560833|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
1100230|NCT00560833|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
1100231|NCT00560833|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
1100232|NCT00560833|O1|Outcome|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
1100233|NCT00560833|O5|Outcome|Esmirtazapine 18mg|Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks
1100234|NCT00560833|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
1100235|NCT00560833|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
1100236|NCT00560833|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
1100237|NCT00560833|O1|Outcome|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
1100238|NCT00560833|O5|Outcome|Esmirtazapine 18mg|Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks
1100239|NCT00560833|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
1100240|NCT00560833|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
1100241|NCT00560833|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
1100242|NCT00560833|O1|Outcome|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
1100243|NCT00560833|O5|Outcome|Esmirtazapine 18mg|Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks
1100244|NCT00560833|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
1100245|NCT00560833|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
1100246|NCT00560833|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
1100247|NCT00560833|O1|Outcome|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
1100248|NCT00560833|O5|Outcome|Esmirtazapine 18mg|Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks
1100249|NCT00560833|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
1100250|NCT00560833|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
1100251|NCT00560833|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
1100252|NCT00560833|O1|Outcome|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
1100253|NCT00560833|E5|Reported Event|Esmirtazapine 18mg|Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks
1100254|NCT00560833|E4|Reported Event|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
1100255|NCT00560833|E3|Reported Event|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
1100256|NCT00560833|E2|Reported Event|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
1100257|NCT00560833|E1|Reported Event|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
1100258|NCT00560794|B1|Baseline|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
1101125|NCT00558571|O3|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
1100259|NCT00560794|P1|Participant Flow|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
1100260|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks.
1100261|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks.
1100262|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks.
1100263|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks.
1100264|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks.
1100265|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks.
1100266|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period.
1100267|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period.
1100268|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
1100269|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
1100270|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
1100271|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
1100272|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
1100273|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
1100274|NCT00560794|E1|Reported Event|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
1100275|NCT00560703|B3|Baseline|Total|Total of all reporting groups
1100276|NCT00560703|B2|Baseline|Placebo|Sugar capsule, once per day for 84 days
1100277|NCT00560703|B1|Baseline|COL-101 (Doxycycline, USP) Capsules|40 MG, Once per day for 84 days
1100278|NCT00560703|P2|Participant Flow|Placebo|Sugar capsule, once per day for 84 days
1100279|NCT00560703|P1|Participant Flow|COL-101 (Doxycycline, USP) Capsules|40 MG, Once per day for 84 days
1100280|NCT00560703|O2|Outcome|Placebo|Sugar capsule, once per day for 84 days
1100281|NCT00560703|O1|Outcome|COL-101 (Doxycycline, USP) Capsules|40 MG, Once per day for 84 days
1100282|NCT00560703|O2|Outcome|Placebo|Sugar capsule, once per day for 84 days
1100283|NCT00560703|O1|Outcome|COL-101 (Doxycycline, USP) Capsules|40 MG, Once per day for 84 days
1100284|NCT00560703|E2|Reported Event|Placebo|Sugar capsule, once per day for 84 days
1100285|NCT00560703|E1|Reported Event|COL-101 (Doxycycline, USP) Capsules|40 MG, Once per day for 84 days
1100286|NCT00560612|B3|Baseline|Total|Total of all reporting groups
1100287|NCT00560612|B2|Baseline|Placebo|Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed).
1100288|NCT00560612|B1|Baseline|Paroxetine|"Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).~Week 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).~Week 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).~Week 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).~Week 12: Final study visit (no study medication dispensed)."
1100289|NCT00560612|P2|Participant Flow|Placebo|Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed).
1101126|NCT00558571|O2|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
1100290|NCT00560612|P1|Participant Flow|Paroxetine|"Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).~Week 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).~Week 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).~Week 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).~Week 12: Final study visit (no study medication dispensed)."
1100291|NCT00560612|O2|Outcome|Placebo|Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed).
1100292|NCT00560612|O1|Outcome|Paroxetine|"Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).~Week 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).~Week 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).~Week 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).~Week 12: Final study visit (no study medication dispensed)."
1100293|NCT00560612|E2|Reported Event|Placebo|Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed).
1100294|NCT00560612|E1|Reported Event|Paroxetine|"Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).~Week 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).~Week 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).~Week 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).~Week 12: Final study visit (no study medication dispensed)."
1100295|NCT00560573|B1|Baseline|All Participants|Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
1100296|NCT00560573|P6|Participant Flow|Figitumumab 20 mg/kg Pemetrexed Expansion|The RP2D of figitumumab 20 mg/kg, was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
1100297|NCT00560573|P5|Participant Flow|Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100298|NCT00560573|P4|Participant Flow|Figitumumab 20 mg/kg RP2D Expansion 1.0 Infusion|The recommended phase 2 dose (R2PD) of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100299|NCT00560573|P3|Participant Flow|Figitumumab 20 mg/kg Dose Escalation|Figitumumab 20 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100300|NCT00560573|P2|Participant Flow|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100367|NCT00560560|O2|Outcome|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
1100301|NCT00560573|P1|Participant Flow|Figitumumab 6 mg/kg|Figitumumab 6 milligram (mg)/kilogram (kg) was administered intravenously (IV) on Day 1 of each cycle over 2.5 hours (hr) up to 6 cycles. Gemcitabine 1250 mg/meter square (m^2) was administered IV over approximately 30 minutes (min) on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100302|NCT00560573|O1|Outcome|Overall Participapnts|Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
1100303|NCT00560573|O1|Outcome|Overall Population|Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
1100304|NCT00560573|O1|Outcome|Overall Population|Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
1101127|NCT00558571|O1|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
1100305|NCT00560573|O6|Outcome|Figitumumab 20 mg/kg Pemetrexed Expansion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
1100306|NCT00560573|O5|Outcome|Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion|The RP2D of igitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100307|NCT00560573|O4|Outcome|Figitumumab 20 mg/kg RP2D Expansion 1.0 Infusion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100308|NCT00560573|O3|Outcome|Figitumumab 20 mg/kg Dose Escalation|Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100309|NCT00560573|O2|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100310|NCT00560573|O1|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100311|NCT00560573|O1|Outcome|Overall Population With PR and CR|Participants with PR and CR who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants with PR and CR who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
1100312|NCT00560573|O3|Outcome|Figitumumab 20 mg/kg Expansion With Pemetrexed|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
1100313|NCT00560573|O2|Outcome|Figitumumab 20 mg/kg With Gemcitabine and Cisplatin|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100314|NCT00560573|O1|Outcome|Overall Population|Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
1100315|NCT00560573|O3|Outcome|Figitumumab 20 mg/kg Expansion With Pemetrexed|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
1100316|NCT00560573|O2|Outcome|Figitumumab 20 mg/kg With Gemcitabine and Cisplatin|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100317|NCT00560573|O1|Outcome|Overall Population|Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
1101109|NCT00558571|O4|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
1100318|NCT00560573|O2|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
1100319|NCT00560573|O1|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
1100320|NCT00560573|O2|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
1100321|NCT00560573|O1|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
1100322|NCT00560573|O2|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100323|NCT00560573|O1|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100324|NCT00560573|O2|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 (absence) and on Day 1 of each cycle (presence) thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100325|NCT00560573|O1|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100326|NCT00560573|O4|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
1100327|NCT00560573|O3|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
1100328|NCT00560573|O2|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100329|NCT00560573|O1|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100330|NCT00560573|O4|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
1100331|NCT00560573|O3|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
1100395|NCT00560508|O1|Outcome|From PPX ER to PPX ER|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
1101110|NCT00558571|O3|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
1100332|NCT00560573|O2|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100333|NCT00560573|O1|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100334|NCT00560573|O1|Outcome|Figitumumab 20 mg/kg Expansion|The RP2D of figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100335|NCT00560573|O4|Outcome|Figitumumab 20 mg/kg Expansion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100336|NCT00560573|O3|Outcome|Figitumumab 20 mg/kg Dose Escalation|Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100337|NCT00560573|O2|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100338|NCT00560573|O1|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100339|NCT00560573|O4|Outcome|Figitumumab 20 mg/kg Expansion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100340|NCT00560573|O3|Outcome|Figitumumab 20 mg/kg Dose Escalation|Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100341|NCT00560573|O2|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100342|NCT00560573|O1|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100343|NCT00560573|O3|Outcome|Figitumumab 20 mg/kg Dose Escalation|Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100344|NCT00560573|O2|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100345|NCT00560573|O1|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100346|NCT00560573|E6|Reported Event|Figitumumab 20 mg/kg Pemetrexed Expansion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
1100347|NCT00560573|E5|Reported Event|Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1101252|NCT00558428|O2|Outcome|Amlodipine 10mg|
1100348|NCT00560573|E4|Reported Event|Figitumumab 20 mg/kg RP2D Expansion 1.0 Infusion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100349|NCT00560573|E3|Reported Event|Figitumumab 20 mg/kg Dose Escalation|Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100350|NCT00560573|E2|Reported Event|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1101128|NCT00558571|O3|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
1100351|NCT00560573|E1|Reported Event|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
1100352|NCT00560560|B3|Baseline|Total|Total of all reporting groups
1100353|NCT00560560|B2|Baseline|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
1100354|NCT00560560|B1|Baseline|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
1100355|NCT00560560|P2|Participant Flow|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
1100356|NCT00560560|P1|Participant Flow|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
1100357|NCT00560560|O2|Outcome|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
1100358|NCT00560560|O1|Outcome|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
1100359|NCT00560560|O2|Outcome|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
1100360|NCT00560560|O1|Outcome|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
1100361|NCT00560560|O2|Outcome|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
1100362|NCT00560560|O1|Outcome|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
1100363|NCT00560560|O2|Outcome|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
1100364|NCT00560560|O1|Outcome|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
1100365|NCT00560560|O2|Outcome|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
1100366|NCT00560560|O1|Outcome|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
1100368|NCT00560560|O1|Outcome|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
1100369|NCT00560560|O2|Outcome|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
1100370|NCT00560560|O1|Outcome|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
1100401|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
1100371|NCT00560560|O2|Outcome|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
1100372|NCT00560560|O1|Outcome|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
1100373|NCT00560560|E2|Reported Event|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
1100374|NCT00560560|E1|Reported Event|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
1100375|NCT00560508|B3|Baseline|Total|Total of all reporting groups
1100376|NCT00560508|B2|Baseline|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
1100377|NCT00560508|B1|Baseline|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
1100378|NCT00560508|P2|Participant Flow|Pramipexole Immediate Release Group (PPX IR)|Pramipexole Immediate Release (IR) tablets of 0.125 mg and 0.5 mg dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
1100379|NCT00560508|P1|Participant Flow|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
1100380|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
1100381|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
1100382|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
1100383|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
1100384|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
1100385|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
1100386|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
1100387|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
1100388|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
1100389|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
1100390|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
1100391|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open label period
1100392|NCT00560508|O2|Outcome|From PPX IR to PPX ER|From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
1100393|NCT00560508|O1|Outcome|From PPX ER to PPX ER|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
1100394|NCT00560508|O2|Outcome|From PPX IR to PPX ER|From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
1100396|NCT00560508|O2|Outcome|From PPX IR to PPX ER|From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day for 12 weeks to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
1100397|NCT00560508|O1|Outcome|From PPX ER to PPX ER|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
1100398|NCT00560508|O2|Outcome|From PPX IR to PPX ER|From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day for 12 weeks to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
1100399|NCT00560508|O1|Outcome|From PPX ER to PPX ER|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
1105853|NCT00549939|O3|Outcome|Alfuzosin 0.2 mg/kg/Day|
1100402|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
1100403|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
1100404|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
1100405|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
1100406|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
1100407|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
1100408|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
1100409|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
1100410|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
1100411|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
1100412|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
1100413|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
1100414|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
1100415|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
1100416|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
1100417|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
1100418|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
1100419|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
1100420|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
1100421|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
1100422|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
1100423|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
1100424|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
1100425|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
1100426|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
1100427|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
1100428|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
1100429|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
1100430|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
1100431|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
1100432|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
1100433|NCT00560508|E2|Reported Event|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
1101129|NCT00558571|O2|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
1100434|NCT00560508|E1|Reported Event|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
1100435|NCT00560417|B3|Baseline|Total|Total of all reporting groups
1100436|NCT00560417|B2|Baseline|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
1100437|NCT00560417|B1|Baseline|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
1100438|NCT00560417|P2|Participant Flow|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
1100439|NCT00560417|P1|Participant Flow|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
1100440|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
1100441|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
1100442|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
1100443|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
1100444|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
1100445|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
1100446|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
1100447|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
1100448|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
1100449|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
1100450|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
1100451|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
1100452|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
1100453|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
1100454|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
1100455|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
1100456|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
1100457|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
1100458|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
1100459|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
1100460|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
1100461|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
1100462|NCT00560417|E2|Reported Event|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
1100463|NCT00560417|E1|Reported Event|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
1100464|NCT00560404|B3|Baseline|Total|Total of all reporting groups
1100465|NCT00560404|B2|Baseline|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
1100466|NCT00560404|B1|Baseline|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
1100467|NCT00560404|P2|Participant Flow|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
1100468|NCT00560404|P1|Participant Flow|C.E.R.A.|Participants received RO0503821 (Continuous Erythropoietin Receptor Activator [C.E.R.A.]) with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
1100469|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
1100470|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
1100471|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
1100472|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
1100473|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
1100474|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
1100475|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
1100476|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
1100477|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
1100478|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
1100479|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
1100480|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
1100481|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
1100482|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
1100483|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
1100484|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
1100485|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
1100486|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
1100487|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
1100488|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
1100489|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
1100490|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
1100491|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
1100492|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
1100493|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
1100494|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
1100495|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
1100496|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
1100497|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
1100498|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
1100499|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
1100500|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
1100501|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
1100502|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
1100503|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
1100504|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
1100505|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
1100506|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
1100507|NCT00560404|E2|Reported Event|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
1100508|NCT00560404|E1|Reported Event|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
1100509|NCT00560391|B6|Baseline|Total|Total of all reporting groups
1100510|NCT00560391|B5|Baseline|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose –finding phase and 13 participants treated in dose expansion phase.
1100511|NCT00560391|B4|Baseline|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100512|NCT00560391|B3|Baseline|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100513|NCT00560391|B2|Baseline|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100514|NCT00560391|B1|Baseline|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100515|NCT00560391|P5|Participant Flow|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
1100516|NCT00560391|P4|Participant Flow|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100517|NCT00560391|P3|Participant Flow|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100518|NCT00560391|P2|Participant Flow|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100519|NCT00560391|P1|Participant Flow|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100520|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
1100521|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100522|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100523|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100524|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100525|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
1100526|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100527|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100528|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1101111|NCT00558571|O2|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
1100529|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100530|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
1100531|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100938|NCT00558896|P1|Participant Flow|Relapsed Myeloma (<4 Prior Regimens): Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100532|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100533|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100534|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100535|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
1100536|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100537|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100538|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100539|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100540|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
1100541|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100542|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100543|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100544|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100545|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
1100546|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100547|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100548|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1101253|NCT00558428|O1|Outcome|Amlodipine 5mg|
1100549|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100550|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
1100551|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100552|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100553|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100554|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100555|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
1100556|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100557|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100558|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100559|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100560|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
1100561|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100562|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100563|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100564|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100565|NCT00560391|O1|Outcome|All Treated Participants|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles; dasatinib (70/100 mg)QD for 28 days, dexamethasone (40mg)given weekly on Days 1, 8, 15, and 22 and lenalidomide (15/20/25mg)QD for 21 days.
1100566|NCT00560391|E5|Reported Event|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100567|NCT00560391|E4|Reported Event|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100568|NCT00560391|E3|Reported Event|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
1101112|NCT00558571|O1|Outcome|Placebo|Oral administration in the fasted state once daily.
1100569|NCT00560391|E2|Reported Event|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100570|NCT00560391|E1|Reported Event|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
1100571|NCT00560352|B4|Baseline|Total|Total of all reporting groups
1100702|NCT00559988|P2|Participant Flow|Physician-Directed OAC|In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed oral anticoagulation therapy consistent with current standards of care.
1100572|NCT00560352|B3|Baseline|Dasatinib, 140 mg QD|Dasatinib, 140 mg, administered QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
1100573|NCT00560352|B2|Baseline|Dasatinib, 100 mg QD|Dasatinib, 100 mg, given QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
1100574|NCT00560352|B1|Baseline|Dasatinib, 50 mg BID|Dasatinib, 50 mg administered twice daily (BID), with 1.0 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg once daily (QD), was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
1100575|NCT00560352|P3|Participant Flow|Dasatinib, 140 mg QD|Dasatinib, 140 mg, administered QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
1100576|NCT00560352|P2|Participant Flow|Dasatinib, 100 mg QD|Dasatinib, 100 mg, given QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
1100577|NCT00560352|P1|Participant Flow|Dasatinib, 50 mg BID|Dasatinib, 50 mg administered twice daily (BID), with 1.0 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg once daily (QD), was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
1100578|NCT00560352|O1|Outcome|All Treated|Dasatinib taken orally every day, QD or BID, depending on the assigned cohort dose level, in 21-day cycles. In a 21-day cycle, bortezomib was also administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was followed 1-2 hours later by the dose of bortezomib. In the dose-escalation phase (Part 1), participants were enrolled sequentially in groups of 3 and individually assessed for safety and dose-limiting toxicity.
1100579|NCT00560352|O3|Outcome|Dasatinib, 140 mg QD|Dasatinib, 140 mg, administered QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
1100580|NCT00560352|O2|Outcome|Dasatinib, 100 mg QD|Dasatinib, 100 mg, given QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
1100619|NCT00560235|B2|Baseline|Figitumumab Dose Extension (Phase 1B)|Figitumumab 20 mg/kg or 30 mg/kg IV administered every 4 weeks (1 cycle). Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
1100581|NCT00560352|O1|Outcome|Dasatinib, 50 mg BID|Dasatinib, 50 mg administered BID, with 1.0 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
1101130|NCT00558571|O1|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
1100582|NCT00560352|O1|Outcome|All Treated|Dasatinib taken orally every day, QD or BID, depending on the assigned cohort dose level, in 21-day cycles. In a 21-day cycle, bortezomib was also administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was followed 1-2 hours later by the dose of bortezomib. In the dose-escalation phase (Part 1), participants were enrolled sequentially in groups of 3 and individually assessed for safety and dose-limiting toxicity.
1100583|NCT00560352|O3|Outcome|Dasatinib, 140 mg QD|Dasatinib, 140 mg, administered QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
1100584|NCT00560352|O2|Outcome|Dasatinib, 100 mg QD|Dasatinib, 100 mg, given QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
1100585|NCT00560352|O1|Outcome|Dasatinib, 50 mg BID|Dasatinib, 50 mg administered BID, with 1.0 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
1100586|NCT00560352|O3|Outcome|Dasatinib, 140 mg QD|Dasatinib, 140 mg, administered QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
1100587|NCT00560352|O2|Outcome|Dasatinib, 100 mg QD|Dasatinib, 100 mg, given QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
1100588|NCT00560352|O1|Outcome|Dasatinib, 50 mg BID|Dasatinib, 50 mg administered twice daily (BID), with 1.0 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg once daily (QD), was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
1100589|NCT00560352|O1|Outcome|All Treated|Dasatinib taken orally every day, once daily (QD) or twice daily (BID), depending on the assigned cohort dose level, in 21-day cycles. In a 21-day cycle, bortezomib was also administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was followed 1-2 hours later by the dose of bortezomib. In the dose-escalation phase (Part 1), participants were enrolled sequentially in groups of 3 and individually assessed for safety and dose-limiting toxicity.
1100590|NCT00560352|E3|Reported Event|Dasatinib, 50 mg BID|Dasatinib, 50 mg administered twice daily (BID), with 1.0 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg once daily (QD), was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
1100620|NCT00560235|B1|Baseline|Figitumumab Dose Escalation (Phase 1)|Figitumumab 20 milligrams per kilogram (mg/kg) intravenous (IV) administered every 4 weeks (1 cycle). If no dose-limiting toxicity (DLT) was identified in the 20-mg/kg cohort, dose escalation proceeded to 30-mg/kg. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
1100591|NCT00560352|E2|Reported Event|Dasatinib, 140 mg QD|Dasatinib, 140 mg, administered QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
1100592|NCT00560352|E1|Reported Event|Dasatinib, 100 mg QD|Dasatinib, 100 mg, given QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
1100593|NCT00560313|B1|Baseline|4CMenB|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB
1100594|NCT00560313|P1|Participant Flow|4CMenB|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB
1100595|NCT00560313|O4|Outcome|Men ACWY-CRM (One Dose)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. We report Numbers (%) of Subjects with Local and Systemic Reactions as indicators of Reactogenicity, by Vaccination post one dose of Men ACWY vaccine.
1100596|NCT00560313|O3|Outcome|4CMenB (Post Dose 3)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. We report Numbers (%) of Subjects with Local and Systemic Reactions as indicators of Reactogenicity, by Vaccination post dose 3.
1100597|NCT00560313|O2|Outcome|4CMenB (Post Dose 2)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. We report Numbers (%) of Subjects with Local and Systemic Reactions as indicators of Reactogenicity, by Vaccination post dose 2.
1100598|NCT00560313|O1|Outcome|4CMenB (Post Dose 1)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. We report Numbers (%) of Subjects with Local and Systemic Reactions as indicators of Reactogenicity, by Vaccination post dose 1
1100599|NCT00560313|O4|Outcome|MenACWY-CRM (Y)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
1100600|NCT00560313|O3|Outcome|MenACWY-CRM (W-135)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
1100601|NCT00560313|O2|Outcome|MenACWY-CRM (C)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
1100602|NCT00560313|O1|Outcome|MenACWY-CRM (A)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
1100603|NCT00560313|O4|Outcome|MenACWY-CRM (Y)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
1100604|NCT00560313|O3|Outcome|MenACWY-CRM (W-135)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
1100605|NCT00560313|O2|Outcome|MenACWY-CRM (C)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
1100606|NCT00560313|O1|Outcome|MenACWY-CRM (A)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
1100607|NCT00560313|O3|Outcome|4CMen B (NZ98/254)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against the (NZ98/254) strain.
1100608|NCT00560313|O2|Outcome|4CMenB (5/99)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against the (5/99) strain
1100609|NCT00560313|O1|Outcome|4CMenB (44/76-SL)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against (44/76-SL) strain
1100610|NCT00560313|O3|Outcome|4CMen B (NZ98/254)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against the (NZ98/254)strain.
1100611|NCT00560313|O2|Outcome|4CMenB (5/99)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against the (5/99)strain
1100612|NCT00560313|O1|Outcome|4CMenB (44/76-SL)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against (44/76-SL) strain
1100613|NCT00560313|E4|Reported Event|Men ACWY-CRM|"All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB.~Post dose 1 MenACWY."
1100614|NCT00560313|E3|Reported Event|4CMenB (3rd Vaccination)|"All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB.~Post dose 3."
1100615|NCT00560313|E2|Reported Event|4CMenB (2nd Vaccination)|"All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB.~Post dose 2."
1100616|NCT00560313|E1|Reported Event|4CMenB (1st Vaccination)|"All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB.~Post dose 1."
1100617|NCT00560235|B4|Baseline|Total|Total of all reporting groups
1100618|NCT00560235|B3|Baseline|Figitumumab 30 mg/kg (Phase 2)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
1100621|NCT00560235|P3|Participant Flow|Figitumumab 30 mg/kg (Phase 2)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
1100622|NCT00560235|P2|Participant Flow|Figitumumab Dose Extension (Phase 1B)|Figitumumab 20 mg/kg or 30 mg/kg IV administered every 4 weeks (1 cycle). Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
1101131|NCT00558571|O3|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
1100623|NCT00560235|P1|Participant Flow|Figitumumab Dose Escalation (Phase 1)|Figitumumab 20 milligrams per kilogram (mg/kg) intravenous (IV) administered every 4 weeks (1 cycle). If no dose-limiting toxicity (DLT) was identified in the 20-mg/kg cohort, dose escalation proceeded to 30-mg/kg. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
1100624|NCT00560235|O1|Outcome|Figitumumab 30 mg/kg (Phase 2)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
1100625|NCT00560235|O3|Outcome|Figitumumab 30 mg/kg Dose Extension (Phase 1B)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle).
1100626|NCT00560235|O2|Outcome|Figitumumab 30 mg/kg Dose Escalation (Phase 1)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle).
1100627|NCT00560235|O1|Outcome|Figitumumab 20 mg/kg Dose Escalation (Phase 1)|Figitumumab 20 mg/kg IV administered every 4 weeks (1 cycle).
1100628|NCT00560235|O3|Outcome|Figitumumab 30 mg/kg Dose Extension (Phase 1B)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
1100629|NCT00560235|O2|Outcome|Figitumumab 30 mg Dose Escalation (Phase 1)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle).
1100630|NCT00560235|O1|Outcome|Figitumumab 20 mg/kg Dose Escalation (Phase 1)|Figitumumab 20 mg/kg IV administered every 4 weeks (1 cycle).
1100631|NCT00560235|O3|Outcome|Figitumumab 30 mg/kg Dose Extension (Phase 1B)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
1100632|NCT00560235|O2|Outcome|Figitumumab 30 mg/kg Dose Escalation (Phase 1)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
1100633|NCT00560235|O1|Outcome|Figitumumab 20 mg/kg Dose Escalation (Phase 1)|Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle).
1100634|NCT00560235|O3|Outcome|Figitumumab 30 mg/kg Dose Extension (Phase 1B)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
1100635|NCT00560235|O2|Outcome|Figitumumab 30 mg/kg Dose Escalation (Phase 1)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
1100636|NCT00560235|O1|Outcome|Figitumumab 20 mg/kg Dose Escalation (Phase 1)|Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle).
1100637|NCT00560235|O3|Outcome|Figitumumab 30 mg/kg Dose Extension (Phase 1B)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
1100638|NCT00560235|O2|Outcome|Figitumumab 30 mg/kg Dose Escalation (Phase 1)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
1100639|NCT00560235|O1|Outcome|Figitumumab 20 mg/kg Dose Escalation (Phase 1)|Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle).
1100640|NCT00560235|O1|Outcome|Figitumumab 30 mg/kg (Phase 2)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
1100641|NCT00560235|O1|Outcome|Figitumumab 30 mg/kg (Phase 2)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
1100642|NCT00560235|O1|Outcome|Figitumumab 30 mg/kg (Phase 2)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
1100643|NCT00560235|E8|Reported Event|Figitumumab 30 mg/kg + Rapamycin (Phase 2)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle). As optional salvage therapy for disease progression, oral rapamycin at 2 to 4 mg/day was administered in combination with figitumumab.
1100644|NCT00560235|E7|Reported Event|Figitumumab 30mg/kg (Phase 2)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle) until unacceptable toxicity or participant withdrawal, for up to 6 cycles.
1100645|NCT00560235|E6|Reported Event|Figitumumab 30 mg/kg + Rapamycin Dose Extension (Phase 1B)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle). As optional salvage therapy for disease progression, oral rapamycin at 2 to 4 mg/day was administered in combination with figitumumab.
1100646|NCT00560235|E5|Reported Event|Figitumumab 30 mg/kg + Rapamycin Dose Escalation (Phase 1)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle). As optional salvage therapy for disease progression, oral rapamycin at 2 to 4 mg/day was administered in combination with figitumumab.
1100647|NCT00560235|E4|Reported Event|Figitumumab 20 mg/kg + Rapamycin Dose Escalation (Phase 1)|Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle). As optional salvage therapy for disease progression, oral rapamycin at 2 to 4 mg/day was administered in combination with figitumumab.
1100648|NCT00560235|E3|Reported Event|Figitumumab 30 mg/kg Dose Extension (Phase 1B)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
1100649|NCT00560235|E2|Reported Event|Figitumumab 30 mg/kg Dose Escalation (Phase 1)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
1100650|NCT00560235|E1|Reported Event|Figitumumab 20 mg/kg Dose Escalation (Phase 1)|Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle).
1100651|NCT00560105|B3|Baseline|Total|Total of all reporting groups
1100652|NCT00560105|B2|Baseline|Lung Flute|Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
1100700|NCT00559988|B2|Baseline|Physician-Directed OAC|In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed oral anticoagulation therapy consistent with current standards of care.
1101246|NCT00558428|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg|
1100701|NCT00559988|B1|Baseline|Home Monitoring Guided OAC|Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of oral anticoagulation therapy.
1101132|NCT00558571|O2|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
1100653|NCT00560105|B1|Baseline|Acapella|Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
1100654|NCT00560105|P2|Participant Flow|Lung Flute|Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
1100655|NCT00560105|P1|Participant Flow|Acapella|Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
1100656|NCT00560105|O2|Outcome|Lung Flute|Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
1100657|NCT00560105|O1|Outcome|Acapella|Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
1100658|NCT00560105|O2|Outcome|Lung Flute|Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
1100659|NCT00560105|O1|Outcome|Acapella|Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
1100660|NCT00560105|O2|Outcome|Lung Flute|Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
1100661|NCT00560105|O1|Outcome|Acapella|Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
1100662|NCT00560105|O2|Outcome|Lung Flute|Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
1100936|NCT00558896|P3|Participant Flow|Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100663|NCT00560105|O1|Outcome|Acapella|Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
1100664|NCT00560105|E2|Reported Event|Lung Flute|Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
1100665|NCT00560105|E1|Reported Event|Acapella|Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
1100666|NCT00560066|B3|Baseline|Total|Total of all reporting groups
1100667|NCT00560066|B2|Baseline|Cell Culture-derived Vaccine (cTIV)|Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine
1100668|NCT00560066|B1|Baseline|Egg-derived Vaccine (TIV)|Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine
1100669|NCT00560066|P2|Participant Flow|Cell Culture-derived Vaccine (cTIV)|Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine.
1100670|NCT00560066|P1|Participant Flow|Egg-derived Vaccine (TIV)|Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine.
1100671|NCT00560066|O2|Outcome|Cell Culture-derived Vaccine (cTIV)|Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine
1100672|NCT00560066|O1|Outcome|Egg-derived Vaccine (TIV)|Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine
1100673|NCT00560066|O4|Outcome|cTIV (Elderly)|Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine
1100674|NCT00560066|O3|Outcome|TIV (Elderly)|Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine
1100675|NCT00560066|O2|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine
1100676|NCT00560066|O1|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of egg-derived influenza virus vaccine
1100677|NCT00560066|O4|Outcome|cTIV (Elderly)|Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine
1100678|NCT00560066|O3|Outcome|TIV (Elderly)|Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine
1100679|NCT00560066|O2|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine
1100680|NCT00560066|O1|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of egg-derived influenza virus vaccine
1100681|NCT00560066|O4|Outcome|cTIV (Elderly)|Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine
1100682|NCT00560066|O3|Outcome|TIV (Elderly)|Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine
1100683|NCT00560066|O2|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine
1100684|NCT00560066|O1|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of egg-derived influenza virus vaccine
1100685|NCT00560066|O4|Outcome|cTIV (Elderly)|Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine
1100686|NCT00560066|O3|Outcome|TIV (Elderly)|Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine
1100687|NCT00560066|O2|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine
1100688|NCT00560066|O1|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of egg-derived influenza virus vaccine
1100689|NCT00560066|O4|Outcome|cTIV (Elderly)|Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine
1100690|NCT00560066|O3|Outcome|TIV (Elderly)|Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine
1100691|NCT00560066|O2|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine
1100692|NCT00560066|O1|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of egg-derived influenza virus vaccine
1100693|NCT00560066|O4|Outcome|cTIV (Elderly)|Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine
1100694|NCT00560066|O3|Outcome|TIV (Elderly)|Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine
1100695|NCT00560066|O2|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine
1100696|NCT00560066|O1|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years years-old received one vaccination of egg-derived influenza virus vaccine
1100697|NCT00560066|E2|Reported Event|Cell Culture-derived Vaccine (cTIV)|Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine
1100698|NCT00560066|E1|Reported Event|Egg-derived Vaccine (TIV)|Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine
1100699|NCT00559988|B3|Baseline|Total|Total of all reporting groups
1101041|NCT00558753|O1|Outcome|1 Placebo|Half of the patients will receive PO placebo for 14 days
1100703|NCT00559988|P1|Participant Flow|Home Monitoring Guided OAC|Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of oral anticoagulation therapy.
1100704|NCT00559988|O2|Outcome|Physician-Directed OAC|In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed oral anticoagulation therapy consistent with current standards of care.
1100705|NCT00559988|O1|Outcome|Home Monitoring Guided OAC|Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of oral anticoagulation therapy.
1100706|NCT00559988|E2|Reported Event|Physician-Directed OAC|In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed oral anticoagulation therapy consistent with current standards of care.
1100707|NCT00559988|E1|Reported Event|Home Monitoring Guided OAC|Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of oral anticoagulation therapy.
1100708|NCT00559962|B9|Baseline|Total|Total of all reporting groups
1100709|NCT00559962|B8|Baseline|AEGR-733 5 mg + Ezetimibe 10 mg|Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
1100710|NCT00559962|B7|Baseline|AEGR-733 5 mg + Fenofibrate 145 mg|Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks
1100711|NCT00559962|B6|Baseline|AEGR-733 5 mg + Atorvastatin 20 mg|Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks
1100712|NCT00559962|B5|Baseline|AEGR-733 10 mg|Oral lomitapide 10 mg every 4 weeks for 12 weeks
1100713|NCT00559962|B4|Baseline|AEGR-733 7.5 mg|Oral lomitapide 7.5 mg every 4 weeks for 12 weeks
1100714|NCT00559962|B3|Baseline|AEGR-733 5 mg|Oral lomitapide 5 mg every 4 weeks for 12 weeks
1100715|NCT00559962|B2|Baseline|AEGR-733 2.5 mg|Oral lomitapide 2.5 mg every 4 weeks for 12 weeks
1100716|NCT00559962|B1|Baseline|Placebo|Oral placebo every 4 weeks for 12 weeks
1100717|NCT00559962|P8|Participant Flow|AEGR-733 5 mg + Ezetimibe 10 mg|Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
1100718|NCT00559962|P7|Participant Flow|AEGR-733 5 mg + Fenofibrate 145 mg|Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks
1100719|NCT00559962|P6|Participant Flow|AEGR-733 5 mg + Atorvastatin 20 mg|Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks
1100720|NCT00559962|P5|Participant Flow|AEGR-733 10 mg|Oral lomitapide 10 mg every 4 weeks for 12 weeks
1100721|NCT00559962|P4|Participant Flow|AEGR-733 7.5 mg|Oral lomitapide 7.5 mg every 4 weeks for 12 weeks
1100722|NCT00559962|P3|Participant Flow|AEGR-733 5 mg|Oral lomitapide 5 mg every 4 weeks for 12 weeks
1100723|NCT00559962|P2|Participant Flow|AEGR-733 2.5 mg|Oral lomitapide 2.5 mg every 4 weeks for 12 weeks
1100724|NCT00559962|P1|Participant Flow|Placebo|Oral placebo every 4 weeks for 12 weeks
1100725|NCT00559962|O8|Outcome|AEGR-733 5 mg + Ezetimibe 10 mg|Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
1100726|NCT00559962|O7|Outcome|AEGR-733 5 mg + Fenofibrate 145 mg|Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks
1100727|NCT00559962|O6|Outcome|AEGR-733 5 mg + Atorvastatin 20 mg|Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks
1100728|NCT00559962|O5|Outcome|AEGR-733 10 mg|Oral lomitapide 10 mg every 4 weeks for 12 weeks
1100729|NCT00559962|O4|Outcome|AEGR-733 7.5 mg|Oral lomitapide 7.5 mg every 4 weeks for 12 weeks
1100730|NCT00559962|O3|Outcome|AEGR-733 5 mg|Oral lomitapide 5 mg every 4 weeks for 12 weeks
1100731|NCT00559962|O2|Outcome|AEGR-733 2.5 mg|Oral lomitapide 2.5 mg every 4 weeks for 12 weeks
1100732|NCT00559962|O1|Outcome|Placebo|Oral placebo every 4 weeks for 12 weeks
1100733|NCT00559962|O2|Outcome|AEGR-733 5 mg|Oral lomitapide 5 mg every 4 weeks for 12 weeks
1100734|NCT00559962|O1|Outcome|Placebo|Oral placebo every 4 weeks for 12 weeks
1100735|NCT00559962|E8|Reported Event|AEGR-733 5 mg + Ezetimibe 10 mg|Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
1100736|NCT00559962|E7|Reported Event|AEGR-733 5 mg + Fenofibrate 145 mg|Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks
1100737|NCT00559962|E6|Reported Event|AEGR-733 5 mg + Atorvastatin 20 mg|Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks
1100738|NCT00559962|E5|Reported Event|AEGR-733 10 mg|Oral lomitapide 10 mg every 4 weeks for 12 weeks
1100739|NCT00559962|E4|Reported Event|AEGR-733 7.5 mg|Oral lomitapide 7.5 mg every 4 weeks for 12 weeks
1100740|NCT00559962|E3|Reported Event|AEGR-733 5 mg|Oral lomitapide 5 mg every 4 weeks for 12 weeks
1100741|NCT00559962|E2|Reported Event|AEGR-733 2.5 mg|Oral lomitapide 2.5 mg every 4 weeks for 12 weeks
1100742|NCT00559962|E1|Reported Event|Placebo|Oral placebo every 4 weeks for 12 weeks
1100763|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
1101104|NCT00558571|O1|Outcome|Placebo|oral administration in the fasted state once daily.
1100743|NCT00559949|B1|Baseline|Arm I|"Patients receive oral selumetinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Selumetinib was administered orally as a free base suspension at a dose of 100 mg twice daily for 28-day cycles. Those participants experiencing Common Terminology Criteria for Adverse Events (CTCAE) v3.0 grade 3 toxicity or worse had their dose reduced to 50 mg twice daily and then to 50 mg once daily, if necessary."
1101133|NCT00558571|O1|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
1100744|NCT00559949|P1|Participant Flow|Arm I|"Patients receive oral selumetinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Selumetinib was administered orally as a free base suspension at a dose of 100 mg twice daily for 28-day cycles. Those participants experiencing Common Terminology Criteria for Adverse Events (CTCAE) v3.0 grade 3 toxicity or worse had their dose reduced to 50 mg twice daily and then to 50 mg once daily, if necessary."
1100745|NCT00559949|O1|Outcome|All Evaluable Participants|Participants evaluable according to protocol guidelines at time of analysis.
1100746|NCT00559949|O1|Outcome|All Evaluable Participants|Participants evaluable according to protocol guidelines at time of analysis.
1100747|NCT00559949|O1|Outcome|All Evaluable Participants|Participants evaluable according to protocol guidelines at time of analysis.
1100748|NCT00559949|O1|Outcome|All Evaluable Participants|Participants evaluable according to protocol guidelines at time of analysis.
1100749|NCT00559949|E1|Reported Event|All Participants|All participants on study.
1100750|NCT00559936|B1|Baseline|Topical Avastin 1.0%|Each patient will receive topical Avastin in one eye.
1100751|NCT00559936|P1|Participant Flow|Topical Avastin 1.0%|Each patient will receive topical Avastin in one eye.
1100752|NCT00559936|O1|Outcome|Topical Avastin 1.0%|Each patient will receive topical Avastin in one eye.
1100753|NCT00559936|O1|Outcome|Topical Avastin 1.0%|Each patient will receive topical Avastin in one eye.
1100754|NCT00559936|E1|Reported Event|Topical Avastin 1.0%|Each patient will receive topical Avastin in one eye.
1100755|NCT00559897|B1|Baseline|3'-Deoxy-3'-[18F]FLT PET & Zoledronic Acid|"Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid~Single photon emission computed tomography. Patient should receive the dose of zoledronic acid within 48 hrs of the first '3'-deoxy-3'-[18F]FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.~3'-deoxy-3'-[18F]FLT: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.~Single photon emission computed tomography: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid."
1100756|NCT00559897|P1|Participant Flow|3'-Deoxy-3'-[18F]FLT PET & Zoledronic Acid|"Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid~Single photon emission computed tomography. Patient should receive the dose of zoledronic acid within 48 hrs of the first '3'-deoxy-3'-[18F]FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.~3'-deoxy-3'-[18F]FLT: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.~Single photon emission computed tomography: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid."
1100757|NCT00559897|O1|Outcome|3'-Deoxy-3'-[18F]FLT PET & Zoledronic Acid|"Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid~Single photon emission computed tomography. Patient should receive the dose of zoledronic acid within 48 hrs of the first '3'-deoxy-3'-[18F]FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.~3'-deoxy-3'-[18F]FLT: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.~Single photon emission computed tomography: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid."
1100758|NCT00559897|E1|Reported Event|3'-Deoxy-3'-[18F]FLT PET & Zoledronic Acid|"Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid~Single photon emission computed tomography. Patient should receive the dose of zoledronic acid within 48 hrs of the first '3'-deoxy-3'-[18F]FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.~3'-deoxy-3'-[18F]FLT: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.~Single photon emission computed tomography: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid."
1100759|NCT00559754|B1|Baseline|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
1100760|NCT00559754|P1|Participant Flow|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|"Participants received doxorubicin 60 milligrams per square meter (mg/m^2) intravenously (IV) followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.~Participants then received bevacizumab 15 mg per kilogram (mg/kg) IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles."
1100761|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
1100762|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
1100764|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
1100939|NCT00558896|O7|Outcome|Relapsed Amyloidosis: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100765|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
1100766|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
1100767|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
1100768|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
1100769|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
1100770|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
1100771|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
1100772|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
1100773|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
1100774|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
1100775|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
1100776|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
1100777|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
1100778|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
1100779|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
1100780|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
1100781|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
1100782|NCT00559754|E1|Reported Event|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
1100904|NCT00559273|O1|Outcome|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
1101247|NCT00558428|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg|
1100817|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
1100783|NCT00559637|B1|Baseline|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
1100784|NCT00559637|P1|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 micrograms per kilogram (mcg/kg) of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
1100785|NCT00559637|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
1100786|NCT00559637|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
1100787|NCT00559637|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
1100788|NCT00559637|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
1100789|NCT00559637|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
1100790|NCT00559637|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
1100791|NCT00559637|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
1100792|NCT00559637|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
1100793|NCT00559637|E1|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
1100794|NCT00559585|B3|Baseline|Total|Total of all reporting groups
1100795|NCT00559585|B2|Baseline|Intravenous (IV) Abatacept|Participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). The Per Protocol (PP) Analysis Population (instead of the Intent-To-Treat Population) was used to perform primary and key secondary efficacy analyses as per regulatory guidelines for non-inferiority studies.
1100796|NCT00559585|B1|Baseline|Subcutaneous (SC) Abatacept|Participants received 125 mg weekly SC abatacept injections (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. The Per Protocol (PP) Analysis Population (instead of the Intent-To-Treat Population) was used to perform primary and key secondary efficacy analyses as per regulatory guidelines for non-inferiority studies.
1100797|NCT00559585|P2|Participant Flow|Intravenous (IV) Abatacept|During the Main study Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). During the Open Label LT Period, participants in both the Main Study and the Anti-TNF Failure Sub-study switched to open-label SC abatacept. The study continued until SC formulation became commercially available on a country basis or the Sponsor terminated the study.
1100798|NCT00559585|P1|Participant Flow|Subcutaneous (SC) Abatacept|During the Main Study Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an IV abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. During the Open Label Long Term (LT) Period, participants in both the Main Study and the Anti-TNF Failure Sub-study switched to open-label SC abatacept. The study continued until SC formulation became commercially available on a country basis or the Sponsor terminated the study.
1100905|NCT00559273|E2|Reported Event|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
1100799|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
1100800|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
1100801|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
1100802|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
1100803|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo). An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
1100804|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of intravenous (IV) abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment. An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
1100805|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
1100806|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
1100807|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
1100808|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
1100809|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
1100810|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
1100811|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
1100812|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
1100813|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
1100814|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
1100815|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
1100816|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
1100818|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
1100819|NCT00559585|O2|Outcome|Intravenous (IV) Abatacept|During the Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
1100820|NCT00559585|O1|Outcome|Subcutaneous (SC) Abatacept|During the Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
1100821|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
1100822|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
1100823|NCT00559585|O2|Outcome|Intravenous (IV) Abatacept|During the Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
1100824|NCT00559585|O1|Outcome|Subcutaneous (SC) Abatacept|During the Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
1100825|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
1100826|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
1100827|NCT00559585|O2|Outcome|Intravenous (IV) Abatacept|During the Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
1100828|NCT00559585|O1|Outcome|Subcutaneous (SC) Abatacept|During the Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
1100829|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
1100830|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
1100831|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
1100832|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
1100833|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
1100906|NCT00559273|E1|Reported Event|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
1100853|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
1100834|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
1100835|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
1100836|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
1100837|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
1100838|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
1100839|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
1100840|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
1100841|NCT00559585|O2|Outcome|Intravenous (IV) Abatacept|During the Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
1100842|NCT00559585|O1|Outcome|Subcutaneous (SC) Abatacept|During the Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
1100843|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
1100844|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception
1100845|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo).
1100846|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with an IV abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment.
1100847|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (Subcutaneous placebo placebo).
1100848|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
1100849|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
1100850|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
1100851|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
1100852|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
1100907|NCT00559104|B3|Baseline|Total|Total of all reporting groups
1101105|NCT00558571|O4|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
1100854|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of intravenous (IV) abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
1100855|NCT00559585|E2|Reported Event|SC Abatacept|During the Main Study Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an IV abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. An Anti-TNF Failure Sub-study was initiated (recruited separately from Main study) using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population. The Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period. During the Open Label LT Period, participants in both the Main Study and the Anti-TNF Failure Sub-study could continue SC abatacept until the SC formulation became commercially available on a country basis or the Sponsor terminated the study.
1100856|NCT00559585|E1|Reported Event|IV Abatacept|During the Main study Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). An Anti-TNF Failure Sub-study was initiated (recruited separately from Main study) using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population. The Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period. During the Open Label LT Period, participants in both the Main Study and the Anti-TNF Failure Sub-study could switch to SC abatacept until the SC formulation became commercially available on a country basis or the Sponsor terminated the study.
1100857|NCT00559507|B1|Baseline|Treatment (Saracatinib)|Patients will receive AZD0530 175mg orally daily for 4 weeks.
1100858|NCT00559507|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib 175 mg PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1100859|NCT00559507|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1100860|NCT00559507|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1100861|NCT00559507|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1100862|NCT00559507|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1100863|NCT00559377|B1|Baseline|All Patients|Patients receive ^18F FMISO IV followed by PET scanning. Patients undergo a second ^18F FMISO PET scan 4-8 weeks later.
1100864|NCT00559377|P1|Participant Flow|Diagnostic (^18F FMISO PET and ^18F FDG PET)|Patients receive ^18F FMISO IV followed by PET scanning. Patients undergo a second ^18F FMISO PET scan 4-8 weeks later. Patients who have not had a prior ^18F FDG PET scan as part of their routine clinical management undergo ^18F FDG PET scanning at baseline.
1100865|NCT00559377|O1|Outcome|Patients Who Had Response Determined by Clinical RECIST|
1100866|NCT00559377|O1|Outcome|Patients With IHC Measures|Patients who had tissue used to evaluate immunohistochemistry measures correlated to FMISO uptake where IHC scores were calculated by standard Allred values.
1100867|NCT00559377|O1|Outcome|Patients With IHC Measures|Patients who had tissue used to evaluate immunohistochemistry measures correlated to FMISO uptake where IHC scores were calculated by standard Allred values.
1100868|NCT00559377|O1|Outcome|Disease-Free Survival|Patients who have remained disease-free throughout the 2 year follow up
1100869|NCT00559377|O1|Outcome|2 Year Overall Survival|Patients who have not been declared deceased for 2 years after their last FMISO scan.
1100870|NCT00559377|E1|Reported Event|Diagnostic (^18F FMISO PET and ^18F FDG PET)|Patients receive ^18F FMISO IV followed by PET scanning. Patients undergo a second ^18F FMISO PET scan 4-8 weeks later. Patients who have not had a prior ^18F FDG PET scan as part of their routine clinical management undergo ^18F FDG PET scanning at baseline.
1100871|NCT00559364|B3|Baseline|Total|Total of all reporting groups
1100872|NCT00559364|B2|Baseline|Placebo|Patients received matching placebo, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
1100873|NCT00559364|B1|Baseline|Viokase®|Patients received Viokase® 16, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
1100874|NCT00559364|P2|Participant Flow|Placebo|Patients received matching placebo, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
1100875|NCT00559364|P1|Participant Flow|Viokase®|Patients received Viokase® 16, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
1101106|NCT00558571|O3|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
1101248|NCT00558428|O2|Outcome|Amlodipine 10mg|
1100908|NCT00559104|B2|Baseline|Carmustine in Conditioning|"Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~carmustine~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~G-CSF"
1100876|NCT00559364|O2|Outcome|Placebo|Patients received matching placebo, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
1100877|NCT00559364|O1|Outcome|Viokase®|Patients received Viokase® 16, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
1100878|NCT00559364|O2|Outcome|Placebo|Patients received matching placebo, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
1100879|NCT00559364|O1|Outcome|Viokase®|Patients received Viokase® 16, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
1100880|NCT00559364|O2|Outcome|Placebo|Patients received matching placebo, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
1100881|NCT00559364|O1|Outcome|Viokase®|Patients received Viokase® 16, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
1100882|NCT00559364|E2|Reported Event|Placebo|Patients received matching placebo, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
1100883|NCT00559364|E1|Reported Event|Viokase®|Patients received Viokase® 16, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
1100884|NCT00559273|B3|Baseline|Total|Total of all reporting groups
1100885|NCT00559273|B2|Baseline|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
1100886|NCT00559273|B1|Baseline|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
1100887|NCT00559273|P2|Participant Flow|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
1100888|NCT00559273|P1|Participant Flow|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered subcutaneously (SC) at a starting dose of 1.2 microgram per kilogram (mcg/kg) once every 4 weeks for 28 weeks.
1100889|NCT00559273|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
1100890|NCT00559273|O1|Outcome|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
1100891|NCT00559273|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
1100892|NCT00559273|O1|Outcome|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
1100893|NCT00559273|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
1100894|NCT00559273|O1|Outcome|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
1100895|NCT00559273|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
1100896|NCT00559273|O1|Outcome|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
1100897|NCT00559273|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
1100898|NCT00559273|O1|Outcome|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
1100899|NCT00559273|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
1100900|NCT00559273|O1|Outcome|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
1100901|NCT00559273|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
1100902|NCT00559273|O1|Outcome|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
1100903|NCT00559273|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
1101107|NCT00558571|O2|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
1100909|NCT00559104|B1|Baseline|Irradiation in Conditioning|"total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~total-body irradiation~G-CSF"
1100910|NCT00559104|P2|Participant Flow|nonTBI-based Conditioning|"Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~carmustine~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~G-CSF"
1100911|NCT00559104|P1|Participant Flow|TBI-based Conditioning|"total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~total-body irradiation~G-CSF"
1100912|NCT00559104|O2|Outcome|Carmustine in Conditioning|"Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~carmustine~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~G-CSF"
1100913|NCT00559104|O1|Outcome|Irradiation in Conditioning|"total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~total-body irradiation~G-CSF"
1100914|NCT00559104|O2|Outcome|Carmustine in Conditioning|"Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~carmustine~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~G-CSF"
1100915|NCT00559104|O1|Outcome|Irradiation in Conditioning|"total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~total-body irradiation~G-CSF"
1100916|NCT00559104|O2|Outcome|Carmustine in Conditioning|"Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~carmustine~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~G-CSF"
1100917|NCT00559104|O1|Outcome|Irradiation in Conditioning|"total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~total-body irradiation~G-CSF"
1100918|NCT00559104|E2|Reported Event|Carmustine in Conditioning|"Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~carmustine~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~G-CSF"
1100919|NCT00559104|E1|Reported Event|Irradiation in Conditioning|"total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~total-body irradiation~G-CSF"
1100920|NCT00559013|B1|Baseline|PSD Veritas Collagen Matrix Reinforcement Arm|Subjects receiving PSD Veritas Collagen Matrix for staple line reinforcement when undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis.
1100921|NCT00559013|P1|Participant Flow|PSD Veritas Collagen Matrix Reinforcement Arm|Subjects receiving PSD Veritas Collagen Matrix for staple line reinforcement when undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis.
1100922|NCT00559013|O1|Outcome|PSD Veritas Collagen Matrix Reinforcement Arm|Subjects receiving PSD Veritas Collagen Matrix for staple line reinforcement when undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis.
1100923|NCT00559013|E1|Reported Event|PSD Veritas Collagen Matrix Reinforcement Arm|Subjects receiving PSD Veritas Collagen Matrix for staple line reinforcement when undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis.
1100924|NCT00558896|B8|Baseline|Total|Total of all reporting groups
1100925|NCT00558896|B7|Baseline|Relapsed Amyloidosis: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100926|NCT00558896|B6|Baseline|Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100927|NCT00558896|B5|Baseline|Relapsed Myeloma (< 4 Prior Regimens): High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100928|NCT00558896|B4|Baseline|Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100929|NCT00558896|B3|Baseline|Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100930|NCT00558896|B2|Baseline|Lenalidomide Refractory Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100931|NCT00558896|B1|Baseline|Relapsed Myeloma (<4 Prior Regimens): Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100932|NCT00558896|P7|Participant Flow|Relapsed Amyloidosis: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100933|NCT00558896|P6|Participant Flow|Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100934|NCT00558896|P5|Participant Flow|Relapsed Myeloma (< 4 Prior Regimens): High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100935|NCT00558896|P4|Participant Flow|Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100937|NCT00558896|P2|Participant Flow|Lenalidomide Refractory Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1105854|NCT00549939|O2|Outcome|Alfuzosin 0.1 mg/kg/Day|
1100940|NCT00558896|O6|Outcome|Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100941|NCT00558896|O5|Outcome|Relapsed Myeloma (< 4 Prior Regimens): High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100942|NCT00558896|O4|Outcome|Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100943|NCT00558896|O3|Outcome|Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100944|NCT00558896|O2|Outcome|Lenalidomide Refractory Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100945|NCT00558896|O1|Outcome|Relapsed Myeloma (<4 Prior Regimens): Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100946|NCT00558896|O7|Outcome|Relapsed Amyloidosis: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100947|NCT00558896|O6|Outcome|Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100948|NCT00558896|O5|Outcome|Relapsed Myeloma (< 4 Prior Regimens): High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100949|NCT00558896|O4|Outcome|Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100950|NCT00558896|O3|Outcome|Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100951|NCT00558896|O2|Outcome|Lenalidomide Refractory Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100952|NCT00558896|O1|Outcome|Relapsed Myeloma (<4 Prior Regimens): Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100953|NCT00558896|O7|Outcome|Relapsed Amyloidosis: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100954|NCT00558896|O6|Outcome|Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100955|NCT00558896|O5|Outcome|Relapsed Myeloma (< 4 Prior Regimens): High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100956|NCT00558896|O4|Outcome|Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100957|NCT00558896|O3|Outcome|Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100958|NCT00558896|O2|Outcome|Lenalidomide Refractory Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100959|NCT00558896|O1|Outcome|Relapsed Myeloma (<4 Prior Regimens): Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100960|NCT00558896|E7|Reported Event|Relapsed Amyloidosis: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100961|NCT00558896|E6|Reported Event|Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100962|NCT00558896|E5|Reported Event|Relapsed Myeloma (< 4 Prior Regimens): High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100963|NCT00558896|E4|Reported Event|Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100964|NCT00558896|E3|Reported Event|Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100965|NCT00558896|E2|Reported Event|Lenalidomide Refractory Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100966|NCT00558896|E1|Reported Event|Relapsed Myeloma (<4 Prior Regimens): Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
1100967|NCT00558870|B3|Baseline|Total|Total of all reporting groups
1100968|NCT00558870|B2|Baseline|Morphine + Methadone|1 Dose oral Slow-Release Morphine (7.5 mg) plus oral Methadone dose (starting dose 2.5 mg) every 12 hours for 15 Days. Immediate-release morphine, if needed, for breakthrough pain.
1100969|NCT00558870|B1|Baseline|Morphine Only|2 Doses oral Slow-Release Morphine (7.5 mg) every 12 hours for 15 Days, and immediate-release morphine, if needed, for breakthrough pain.
1100970|NCT00558870|P2|Participant Flow|Morphine + Methadone|1 Dose oral Slow-Release Morphine (7.5 mg) plus oral Methadone dose (starting dose 2.5 mg) every 12 hours for 15 Days. Immediate-release morphine, if needed, for breakthrough pain.
1100971|NCT00558870|P1|Participant Flow|Morphine Only|2 Doses oral Slow-Release Morphine (7.5 mg) every 12 hours for 15 Days, and immediate-release morphine, if needed, for breakthrough pain.
1101108|NCT00558571|O1|Outcome|Placebo|Oral administration in the fasted state once daily.
1100972|NCT00558870|O2|Outcome|Morphine + Methadone|1 Dose oral Slow-Release Morphine (7.5 mg) plus oral Methadone dose (starting dose 2.5 mg) every 12 hours for 15 Days. Immediate-release morphine, if needed, for breakthrough pain.
1100973|NCT00558870|O1|Outcome|Morphine Only|2 Doses oral Slow-Release Morphine (7.5 mg) every 12 hours for 15 Days, and immediate-release morphine, if needed, for breakthrough pain.
1101043|NCT00558753|O1|Outcome|1 Placebo|Half of the patients will receive PO placebo for 14 days
1105855|NCT00549939|O1|Outcome|Placebo|
1100974|NCT00558870|O2|Outcome|Morphine + Methadone|1 Dose oral Slow-Release Morphine (7.5 mg) plus oral Methadone dose (starting dose 2.5 mg) every 12 hours for 15 Days. Immediate-release morphine, if needed, for breakthrough pain.
1100975|NCT00558870|O1|Outcome|Morphine Only|2 Doses oral Slow-Release Morphine (7.5 mg) every 12 hours for 15 Days, and immediate-release morphine, if needed, for breakthrough pain.
1100976|NCT00558870|E2|Reported Event|Morphine + Methadone|1 Dose oral Slow-Release Morphine (7.5 mg) plus oral Methadone dose (starting dose 2.5 mg) every 12 hours for 15 Days. Immediate-release morphine, if needed, for breakthrough pain.
1100977|NCT00558870|E1|Reported Event|Morphine Only|2 Doses oral Slow-Release Morphine (7.5 mg) every 12 hours for 15 Days, and immediate-release morphine, if needed, for breakthrough pain.
1100978|NCT00558831|B1|Baseline|Subjects|Each subject was randomized to applied benzoyl peroxide 2.5% cream formulation to one side of the face and benzoyl peroxide 2.5% cream formulation plus moisturizer to the other side of the face.
1100979|NCT00558831|P1|Participant Flow|Subjects|Each subject was randomized to applied benzoyl peroxide 2.5% cream formulation to one side of the face and benzoyl peroxide 2.5% cream formulation plus moisturizer to the other side of the face.
1100980|NCT00558831|O2|Outcome|Benzoyl Peroxide 2.5% Cream Plus Moisturizing Lotion|
1100981|NCT00558831|O1|Outcome|Benzoyl Peroxide 2.5% Cream|
1100982|NCT00558831|E2|Reported Event|Benzoyl Peroxide 2.5% Plus Moisturizing Lotion|
1100983|NCT00558831|E1|Reported Event|Benzoyl Peroxide 2.5%|
1100984|NCT00558792|B4|Baseline|Total|Total of all reporting groups
1100985|NCT00558792|B3|Baseline|Isovue 370, 90 mL|iopamidol injection 370, 90 mL
1100986|NCT00558792|B2|Baseline|Isovue 370, 80 mL|iopamidol injection 370, 80 mL
1100987|NCT00558792|B1|Baseline|Isovue 370, 70 mL|iopamidol injection 370, 70 mL
1100988|NCT00558792|P3|Participant Flow|Isovue 370, 90 mL|iopamidol injection 370, 90 mL
1100989|NCT00558792|P2|Participant Flow|Isovue 370, 80 mL|iopamidol injection 370, 80 mL
1100990|NCT00558792|P1|Participant Flow|Isovue 370, 70 mL|iopamidol injection 370, 70 mL
1100991|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
1100992|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
1100993|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
1100994|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
1100995|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
1100996|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
1100997|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
1100998|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
1100999|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
1101000|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
1101001|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
1101002|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
1101003|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
1101004|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
1101005|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
1101006|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
1101007|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
1101008|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
1101117|NCT00558571|O4|Outcome|100mg Empagliflozin|oral administration in the fasted state once daily.
1101009|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
1101010|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
1101011|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
1101012|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
1101013|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
1101014|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
1101015|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
1101016|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
1101017|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
1101018|NCT00558792|O3|Outcome|Isovue 370, 90 mL|iopamidol injection 370, 90 mL
1101019|NCT00558792|O2|Outcome|Isovue 370, 80 mL|iopamidol injection 370, 80 mL
1101020|NCT00558792|O1|Outcome|Isovue 370, 70 mL|iopamidol injection 370, 70 mL
1101021|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
1101022|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
1101023|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
1101024|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
1101025|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
1101026|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
1101027|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
1101028|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
1101029|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
1101030|NCT00558792|E3|Reported Event|Isovue 370, 90 mL|iopamidol injection 370, 90 mL
1101031|NCT00558792|E2|Reported Event|Isovue 370, 80 mL|iopamidol injection 370, 80 mL
1101032|NCT00558792|E1|Reported Event|Isovue 370, 70 mL|iopamidol injection 370, 70 mL
1101033|NCT00558753|B3|Baseline|Total|Total of all reporting groups
1101034|NCT00558753|B2|Baseline|2 Pregabalin|PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
1101035|NCT00558753|B1|Baseline|1 Placebo|Half of the patients will receive PO placebo for 14 days
1101036|NCT00558753|P2|Participant Flow|2 Pregabalin|PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
1101037|NCT00558753|P1|Participant Flow|1 Placebo|Half of the patients will receive oral (PO) placebo for 14 days
1101038|NCT00558753|O2|Outcome|2 Pregabalin|PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
1101039|NCT00558753|O1|Outcome|1 Placebo|Half of the patients will receive PO placebo for 14 days
1101040|NCT00558753|O2|Outcome|2 Pregabalin|PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
1101042|NCT00558753|O2|Outcome|2 Pregabalin|PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
1101044|NCT00558753|E2|Reported Event|2 Pregabalin|PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
1101045|NCT00558753|E1|Reported Event|1 Placebo|Half of the patients will receive PO placebo for 14 days
1101046|NCT00558701|B3|Baseline|Total|Total of all reporting groups
1101047|NCT00558701|B2|Baseline|Silverlon Alone|"Patients receiving treatment of skin donor sites with Silverlon wound contact dressing alone (i.e., without active electrical stimulation)~Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
1101048|NCT00558701|B1|Baseline|Microcurrent Stimulator + Silverlon|"Patients receiving active electrical stimulation (15-50 microamps) during treatment of skin donor sites with Silverlon wound contact dressing.~Intervention is active electrical stimulation via microcurrent stimulator.~Microcurrent stimulator: Microcurrent stimulation from 15-50 microamps Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
1101049|NCT00558701|P2|Participant Flow|Silverlon Alone|"Patients receiving treatment of skin donor sites with Silverlon wound contact dressing alone (i.e., without active electrical stimulation)~Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
1101050|NCT00558701|P1|Participant Flow|Microcurrent Stimulator + Silverlon|"Patients receiving active electrical stimulation (15-50 microamps) during treatment of skin donor sites with Silverlon wound contact dressing. Intervention is active electrical stimulation via microcurrent stimulator.~Microcurrent stimulator: Microcurrent stimulation from 15-50 microamps~Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
1101051|NCT00558701|O2|Outcome|Silverlon Alone|"Patients receiving treatment of skin donor sites with Silverlon wound contact dressing alone (i.e., without active electrical stimulation)~Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
1101052|NCT00558701|O1|Outcome|Microcurrent Stimulator + Silverlon|"Patients receiving active electrical stimulation (15-50 microamps) during treatment of skin donor sites with Silverlon wound contact dressing. Intervention is active electrical stimulation via microcurrent stimulator.~Microcurrent stimulator: Microcurrent stimulation from 15-50 microamps~Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
1101053|NCT00558701|E2|Reported Event|Silverlon Alone|"Patients receiving treatment of skin donor sites with Silverlon wound contact dressing alone (i.e., without active electrical stimulation)~Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
1101054|NCT00558701|E1|Reported Event|Microcurrent Stimulator + Silverlon|"Patients receiving active electrical stimulation (15-50 microamps) during treatment of skin donor sites with Silverlon wound contact dressing. Intervention is active electrical stimulation via microcurrent stimulator.~Microcurrent stimulator: Microcurrent stimulation from 15-50 microamps~Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
1101055|NCT00558636|B3|Baseline|Total|Total of all reporting groups
1101056|NCT00558636|B2|Baseline|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
1101057|NCT00558636|B1|Baseline|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
1101058|NCT00558636|P2|Participant Flow|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
1101059|NCT00558636|P1|Participant Flow|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
1101060|NCT00558636|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
1101061|NCT00558636|O1|Outcome|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
1101062|NCT00558636|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
1101063|NCT00558636|O1|Outcome|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
1101064|NCT00558636|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
1101249|NCT00558428|O1|Outcome|Amlodipine 5mg|
1101065|NCT00558636|O1|Outcome|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
1101066|NCT00558636|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
1101067|NCT00558636|O1|Outcome|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
1101068|NCT00558636|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
1101069|NCT00558636|O1|Outcome|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
1101070|NCT00558636|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
1101071|NCT00558636|O1|Outcome|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
1101072|NCT00558636|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
1101073|NCT00558636|O1|Outcome|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
1101074|NCT00558636|E2|Reported Event|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
1101075|NCT00558636|E1|Reported Event|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
1101076|NCT00558571|B5|Baseline|Total|Total of all reporting groups
1101077|NCT00558571|B4|Baseline|100mg Empagliflozin|oral administration in the fasted state once daily.
1101078|NCT00558571|B3|Baseline|25mg Empagliflozin|oral administration in the fasted state once daily.
1101079|NCT00558571|B2|Baseline|10mg Empagliflozin|oral administration in the fasted state once daily.
1101080|NCT00558571|B1|Baseline|Placebo|oral administration in the fasted state once daily.
1101081|NCT00558571|P4|Participant Flow|100mg Empagliflozin|Oral administration in the fasted state once daily.
1101082|NCT00558571|P3|Participant Flow|25mg Empagliflozin|Oral administration in the fasted state once daily.
1101083|NCT00558571|P2|Participant Flow|10mg Empagliflozin|Oral administration in the fasted state once daily.
1101084|NCT00558571|P1|Participant Flow|Placebo|Oral administration in the fasted state once daily
1101085|NCT00558571|O4|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily
1101086|NCT00558571|O3|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily
1101087|NCT00558571|O2|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily
1101088|NCT00558571|O1|Outcome|Placebo|Oral administration in the fasted state once daily
1101089|NCT00558571|O4|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
1101090|NCT00558571|O3|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
1101091|NCT00558571|O2|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
1101092|NCT00558571|O1|Outcome|Placebo|Oral administration in the fasted state once daily.
1101093|NCT00558571|O4|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
1101094|NCT00558571|O3|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
1101095|NCT00558571|O2|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
1101096|NCT00558571|O1|Outcome|Placebo|Oral administration in the fasted state once daily.
1101097|NCT00558571|O4|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
1101098|NCT00558571|O3|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
1101099|NCT00558571|O2|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
1101100|NCT00558571|O1|Outcome|Placebo|Oral administration in the fasted state once daily.
1101101|NCT00558571|O4|Outcome|100mg Empagliflozin|oral administration in the fasted state once daily.
1101102|NCT00558571|O3|Outcome|25mg Empagliflozin|oral administration in the fasted state once daily.
1101103|NCT00558571|O2|Outcome|10mg Empagliflozin|oral administration in the fasted state once daily.
1101113|NCT00558571|O4|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
1101114|NCT00558571|O3|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
1101115|NCT00558571|O2|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
1101116|NCT00558571|O1|Outcome|Placebo|Oral administration in the fasted state once daily.
1101134|NCT00558571|O3|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
1101135|NCT00558571|O2|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
1101136|NCT00558571|O1|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
1101137|NCT00558571|O3|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
1101138|NCT00558571|O2|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
1101139|NCT00558571|O1|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
1101140|NCT00558571|O3|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
1101141|NCT00558571|O2|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
1101142|NCT00558571|O1|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
1101143|NCT00558571|O3|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
1101144|NCT00558571|O2|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
1101145|NCT00558571|O1|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
1101146|NCT00558571|O4|Outcome|100mg Empagliflozin|oral administration in the fasted state once daily.
1101147|NCT00558571|O3|Outcome|25mg Empagliflozin|oral administration in the fasted state once daily.
1101148|NCT00558571|O2|Outcome|10mg Empagliflozin|oral administration in the fasted state once daily.
1101149|NCT00558571|O1|Outcome|Placebo|oral administration in the fasted state once daily.
1101150|NCT00558571|O4|Outcome|100mg Empagliflozin|oral administration in the fasted state once daily.
1101151|NCT00558571|O3|Outcome|25mg Empagliflozin|oral administration in the fasted state once daily.
1101152|NCT00558571|O2|Outcome|10mg Empagliflozin|oral administration in the fasted state once daily.
1101153|NCT00558571|O1|Outcome|Placebo|oral administration in the fasted state once daily.
1101154|NCT00558571|E4|Reported Event|100mg Empagliflozin|oral administration in the fasted state once daily
1101155|NCT00558571|E3|Reported Event|25mg Empagliflozin|oral administration in the fasted state once daily
1101156|NCT00558571|E2|Reported Event|10mg Empagliflozin|oral administration in the fasted state once daily
1101157|NCT00558571|E1|Reported Event|Placebo|oral administration in the fasted state once daily
1101158|NCT00558558|B1|Baseline|Fermented Soy Supplement|4 oz Haelan orally twice daily for 8 weeks
1101159|NCT00558558|P1|Participant Flow|Fermented Soy Supplement|4 oz Haelan orally twice daily for 8 weeks
1101160|NCT00558558|O1|Outcome|Fermented Soy Supplement|4 oz Haelan orally twice daily for 8 weeks
1101161|NCT00558558|E1|Reported Event|Fermented Soy Supplement|4 oz Haelan orally twice daily for 8 weeks
1101162|NCT00558467|B3|Baseline|Total|Total of all reporting groups
1101163|NCT00558467|B2|Baseline|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
1101164|NCT00558467|B1|Baseline|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
1101165|NCT00558467|P2|Participant Flow|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
1101166|NCT00558467|P1|Participant Flow|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
1101167|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
1101168|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
1101169|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
1101170|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
1101171|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
1101172|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
1101173|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
1101174|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
1101175|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
1101176|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
1101177|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
1101178|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
1105856|NCT00549939|O3|Outcome|Alfuzosin 0.2 mg/kg/Day|
1101179|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
1101180|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
1101181|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
1101182|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
1101183|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
1101184|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
1101185|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
1101186|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
1101187|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
1101188|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
1101189|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
1101190|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
1101191|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
1101192|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
1101193|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
1101194|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
1101195|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
1101196|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
1101197|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
1101198|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
1101250|NCT00558428|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg|
1101199|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
1101200|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
1101201|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
1101202|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
1101203|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
1101204|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
1101205|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
1101206|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
1101207|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
1101208|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
1101209|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
1101210|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
1101211|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
1101212|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
1101213|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
1101214|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
1101215|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
1101216|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
1101217|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
1101218|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
1101219|NCT00558467|E2|Reported Event|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
1101220|NCT00558467|E1|Reported Event|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
1101221|NCT00558428|B5|Baseline|Total|Total of all reporting groups
1101222|NCT00558428|B4|Baseline|Telmisartan 80mg and Amlodipine 5mg|
1101223|NCT00558428|B3|Baseline|Telmisartan 40mg and Amlodipine 5mg|
1101224|NCT00558428|B2|Baseline|Amlodipine 10mg|
1101225|NCT00558428|B1|Baseline|Amlodipine 5mg|
1101226|NCT00558428|P4|Participant Flow|Telmisartan 80mg and Amlodipine 5mg|
1101227|NCT00558428|P3|Participant Flow|Telmisartan 40mg and Amlodipine 5mg|
1101228|NCT00558428|P2|Participant Flow|Amlodipine 10mg|
1101229|NCT00558428|P1|Participant Flow|Amlodipine 5mg|
1101230|NCT00558428|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg|
1101231|NCT00558428|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg|
1101232|NCT00558428|O2|Outcome|Amlodipine 10mg|
1101233|NCT00558428|O1|Outcome|Amlodipine 5mg|
1101234|NCT00558428|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg|
1101235|NCT00558428|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg|
1101236|NCT00558428|O2|Outcome|Amlodipine 10mg|
1101237|NCT00558428|O1|Outcome|Amlodipine 5mg|
1101238|NCT00558428|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg|
1101239|NCT00558428|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg|
1101240|NCT00558428|O2|Outcome|Amlodipine 10mg|
1101241|NCT00558428|O1|Outcome|Amlodipine 5mg|
1101242|NCT00558428|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg|
1101243|NCT00558428|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg|
1101244|NCT00558428|O2|Outcome|Amlodipine 10mg|
1101245|NCT00558428|O1|Outcome|Amlodipine 5mg|
1101254|NCT00558428|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg|
1101255|NCT00558428|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg|
1101256|NCT00558428|O2|Outcome|Amlodipine 10mg|
1101257|NCT00558428|O1|Outcome|Amlodipine 5mg|
1101258|NCT00558428|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg|
1101259|NCT00558428|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg|
1101260|NCT00558428|O2|Outcome|Amlodipine 10mg|
1101261|NCT00558428|O1|Outcome|Amlodipine 5mg|
1101262|NCT00558428|E4|Reported Event|Telmisartan 80mg and Amlodipine 5mg|
1101263|NCT00558428|E3|Reported Event|Telmisartan 40mg and Amlodipine 5mg|
1101264|NCT00558428|E2|Reported Event|Amlodipine 10mg|
1101265|NCT00558428|E1|Reported Event|Amlodipine 5mg|
1101266|NCT00558363|B3|Baseline|Total|Total of all reporting groups
1101267|NCT00558363|B2|Baseline|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
1101268|NCT00558363|B1|Baseline|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
1101269|NCT00558363|P2|Participant Flow|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
1101270|NCT00558363|P1|Participant Flow|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
1101271|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
1101272|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
1101273|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
1101274|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
1101275|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
1101276|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
1101277|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
1101278|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
1101279|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
1101280|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
1101281|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
1101282|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
1101283|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
1101284|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
1101285|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
1101286|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
1101287|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
1101288|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
1101289|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
1101290|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
1101291|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
1101292|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
1101293|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
1101294|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
1101295|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
1101296|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
1101297|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
1101298|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
1101299|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
1101300|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
1101301|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
1101302|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
1101303|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
1101304|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
1101305|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
1101306|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
1101307|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
1101308|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
1101309|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
1101310|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
1101311|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
1101312|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
1101313|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
1101314|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
1103628|NCT00554216|B2|Baseline|VI-0521 Low|PHEN/TPM 3.75/23
1101315|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
1101316|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
1101317|NCT00558363|E2|Reported Event|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
1101318|NCT00558363|E1|Reported Event|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
1101319|NCT00558285|B6|Baseline|Total|Total of all reporting groups
1101320|NCT00558285|B5|Baseline|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101321|NCT00558285|B4|Baseline|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101322|NCT00558285|B3|Baseline|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101323|NCT00558285|B2|Baseline|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101324|NCT00558285|B1|Baseline|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101325|NCT00558285|P5|Participant Flow|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101384|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
1105857|NCT00549939|O2|Outcome|Alfuzosin 0.1 mg/kg/Day|
1101326|NCT00558285|P4|Participant Flow|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101327|NCT00558285|P3|Participant Flow|Indacaterol/Glycopyrrolate 150 μg/100 μg|"One capsule indacaterol/glycopyrrolate 150 μg/50 μg and one capsule 50μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101328|NCT00558285|P2|Participant Flow|Indacaterol/Glycopyrrolate 300 μg/100 μg|"One capsule indacaterol/glycopyrrolate 300 μg/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101329|NCT00558285|P1|Participant Flow|Indacaterol/Glycopyrrolate 600 μg/100 μg|"Two capsules indacaterol/glycopyrrolate 300 μg/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101330|NCT00558285|O5|Outcome|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101331|NCT00558285|O4|Outcome|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101332|NCT00558285|O3|Outcome|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101333|NCT00558285|O2|Outcome|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101334|NCT00558285|O1|Outcome|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101335|NCT00558285|O5|Outcome|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101336|NCT00558285|O4|Outcome|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101337|NCT00558285|O3|Outcome|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101338|NCT00558285|O2|Outcome|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101339|NCT00558285|O1|Outcome|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101340|NCT00558285|O5|Outcome|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101341|NCT00558285|O4|Outcome|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101342|NCT00558285|O3|Outcome|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101488|NCT00558064|B2|Baseline|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
1103629|NCT00554216|B1|Baseline|Placebo|
1101343|NCT00558285|O2|Outcome|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101344|NCT00558285|O1|Outcome|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101345|NCT00558285|O5|Outcome|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101346|NCT00558285|O4|Outcome|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101347|NCT00558285|O3|Outcome|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101348|NCT00558285|O2|Outcome|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101349|NCT00558285|O1|Outcome|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101350|NCT00558285|O5|Outcome|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1105858|NCT00549939|O1|Outcome|Placebo|
1101351|NCT00558285|O4|Outcome|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101352|NCT00558285|O3|Outcome|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101353|NCT00558285|O2|Outcome|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101354|NCT00558285|O1|Outcome|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101355|NCT00558285|O5|Outcome|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101356|NCT00558285|O4|Outcome|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101357|NCT00558285|O3|Outcome|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101358|NCT00558285|O2|Outcome|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101359|NCT00558285|O1|Outcome|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101360|NCT00558285|O5|Outcome|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101361|NCT00558285|O4|Outcome|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101362|NCT00558285|O3|Outcome|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101363|NCT00558285|O2|Outcome|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101364|NCT00558285|O1|Outcome|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101365|NCT00558285|E5|Reported Event|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol /albuterol as rescue medication was permitted throughout the study."
1101366|NCT00558285|E4|Reported Event|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101367|NCT00558285|E3|Reported Event|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101489|NCT00558064|B1|Baseline|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
1101490|NCT00558064|P2|Participant Flow|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
1101368|NCT00558285|E2|Reported Event|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101369|NCT00558285|E1|Reported Event|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
1101370|NCT00558272|B3|Baseline|Total|Total of all reporting groups
1101371|NCT00558272|B2|Baseline|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
1101372|NCT00558272|B1|Baseline|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
1101373|NCT00558272|P2|Participant Flow|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
1101374|NCT00558272|P1|Participant Flow|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
1101375|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
1101376|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
1101377|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
1101378|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
1101379|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
1101380|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
1101381|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
1101382|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
1101383|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
1101385|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
1101386|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
1101387|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
1101388|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
1101389|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
1101390|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
1101391|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
1101392|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
1101393|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
1101394|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
1101395|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
1101396|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
1101397|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
1101398|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
1101399|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
1101400|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
1101401|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
1101402|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
1101403|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
1101404|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
1101405|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
1101406|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
1101407|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
1101408|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
1101409|NCT00558272|E2|Reported Event|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
1101410|NCT00558272|E1|Reported Event|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
1101411|NCT00558259|B3|Baseline|Total|Total of all reporting groups
1101412|NCT00558259|B2|Baseline|Placebo|Matching placebo
1101413|NCT00558259|B1|Baseline|Dabigatran|Dabigatran 150mg bid
1101414|NCT00558259|P2|Participant Flow|Placebo|Matching placebo
1101415|NCT00558259|P1|Participant Flow|Dabigatran|Dabigatran 150mg bid (twice daily)
1101416|NCT00558259|O2|Outcome|Placebo|Matching placebo
1101417|NCT00558259|O1|Outcome|Dabigatran|Dabigatran 150mg bid
1101418|NCT00558259|O2|Outcome|Placebo|Matching placebo
1101419|NCT00558259|O1|Outcome|Dabigatran|Dabigatran 150mg bid
1101420|NCT00558259|O2|Outcome|Placebo|Matching placebo
1101421|NCT00558259|O1|Outcome|Dabigatran|Dabigatran 150mg bid
1101422|NCT00558259|O2|Outcome|Placebo|Matching placebo
1101423|NCT00558259|O1|Outcome|Dabigatran|Dabigatran 150mg bid
1101424|NCT00558259|O2|Outcome|Placebo|Matching placebo
1101425|NCT00558259|O1|Outcome|Dabigatran|Dabigatran 150mg bid
1101426|NCT00558259|O2|Outcome|Placebo|Matching placebo
1101427|NCT00558259|O1|Outcome|Dabigatran|Dabigatran 150mg bid
1101428|NCT00558259|O2|Outcome|Placebo|Matching placebo
1101429|NCT00558259|O1|Outcome|Dabigatran|Dabigatran 150mg bid
1101430|NCT00558259|O2|Outcome|Placebo|Matching placebo
1101431|NCT00558259|O1|Outcome|Dabigatran|Dabigatran 150mg bid
1101432|NCT00558259|E2|Reported Event|Placebo|Matching placebo
1101433|NCT00558259|E1|Reported Event|Dabigatran|Dabigatran 150mg bid
1101538|NCT00558012|P2|Participant Flow|Placebo|"Placebo~One-time dose: Intravenous saline"
1101434|NCT00558246|B1|Baseline|Prineo and Suture|On same patient, one breast is randomized to control (intradermal sutures) and one breast is randomized to experimental arm (DERMABOND PROTAPE). Patient is own control. Protape is supplied as a single use mesh device with sufficient adhesive to saturate mesh. Sutures were not supplied.
1101435|NCT00558246|P1|Participant Flow|Prineo and Suture|On same patient, one breast is randomized to control (intradermal sutures) and one breast is randomized to experimental arm (DERMABOND PROTAPE). Patient is own control. Protape is supplied as a single use mesh device with sufficient adhesive to saturate mesh. Sutures were not supplied.
1101436|NCT00558246|O2|Outcome|Suture|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
1101437|NCT00558246|O1|Outcome|Prineo|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
1101438|NCT00558246|O2|Outcome|Suture|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
1101439|NCT00558246|O1|Outcome|Prineo|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
1101440|NCT00558246|O2|Outcome|Suture|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
1101441|NCT00558246|O1|Outcome|Prineo|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
1101442|NCT00558246|O2|Outcome|Suture|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
1101443|NCT00558246|O1|Outcome|Prineo|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
1101444|NCT00558246|O2|Outcome|Suture|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
1101789|NCT00556712|B3|Baseline|Total|Total of all reporting groups
1101445|NCT00558246|O1|Outcome|Prineo|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
1101446|NCT00558246|E3|Reported Event|Procedure|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
1101447|NCT00558246|E2|Reported Event|Suture|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
1101448|NCT00558246|E1|Reported Event|Prineo|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
1101449|NCT00558103|B6|Baseline|Total|Total of all reporting groups
1101450|NCT00558103|B5|Baseline|Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg|Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
1101451|NCT00558103|B4|Baseline|Cohort 2: Pazopanib 800 mg|Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
1101452|NCT00558103|B3|Baseline|Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
1101453|NCT00558103|B2|Baseline|Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
1101454|NCT00558103|B1|Baseline|Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
1101455|NCT00558103|P6|Participant Flow|Open-label Lapatinib 1500 mg|Participants who received pazopanib 800 mg in the randomized treatment phase were given the option to receive oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) QD.
1101456|NCT00558103|P5|Participant Flow|Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg|Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
1101457|NCT00558103|P4|Participant Flow|Cohort 2: Pazopanib 800 mg|Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
1101458|NCT00558103|P3|Participant Flow|Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
1101459|NCT00558103|P2|Participant Flow|Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
1101460|NCT00558103|P1|Participant Flow|Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
1101461|NCT00558103|O5|Outcome|Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg|Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
1101462|NCT00558103|O4|Outcome|Cohort 2: Pazopanib 800 mg|Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
1102292|NCT00557245|E3|Reported Event|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
1101463|NCT00558103|O3|Outcome|Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
1101464|NCT00558103|O2|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
1101465|NCT00558103|O1|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
1101466|NCT00558103|O5|Outcome|Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg|Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
1101467|NCT00558103|O4|Outcome|Cohort 2: Pazopanib 800 mg|Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
1101468|NCT00558103|O3|Outcome|Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
1101469|NCT00558103|O2|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
1101470|NCT00558103|O1|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
1101471|NCT00558103|O5|Outcome|Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg|Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
1101472|NCT00558103|O4|Outcome|Cohort 2: Pazopanib 800 mg|Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
1101473|NCT00558103|O3|Outcome|Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
1101474|NCT00558103|O2|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
1101475|NCT00558103|O1|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
1101476|NCT00558103|O5|Outcome|Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg|Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
1101477|NCT00558103|O4|Outcome|Cohort 2: Pazopanib 800 mg|Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
1101478|NCT00558103|O3|Outcome|Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
1101479|NCT00558103|O2|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
1101480|NCT00558103|O1|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
1101481|NCT00558103|E6|Reported Event|Open-label Lapatinib 1500 mg|Participants who received pazopanib 800 mg in the randomized treatment phase were given the option to receive oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) QD.
1101482|NCT00558103|E5|Reported Event|Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg|Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
1101483|NCT00558103|E4|Reported Event|Cohort 2: Pazopanib 800 mg|Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
1101484|NCT00558103|E3|Reported Event|Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
1101485|NCT00558103|E2|Reported Event|Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
1101486|NCT00558103|E1|Reported Event|Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
1101487|NCT00558064|B3|Baseline|Total|Total of all reporting groups
1101491|NCT00558064|P1|Participant Flow|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
1101492|NCT00558064|O2|Outcome|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
1101493|NCT00558064|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
1101494|NCT00558064|O2|Outcome|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
1101495|NCT00558064|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
1101496|NCT00558064|O2|Outcome|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
1101497|NCT00558064|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
1101498|NCT00558064|O2|Outcome|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
1101499|NCT00558064|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
1101500|NCT00558064|O2|Outcome|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
1101501|NCT00558064|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
1101502|NCT00558064|O2|Outcome|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
1101503|NCT00558064|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
1101504|NCT00558064|O2|Outcome|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
1101505|NCT00558064|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
1101506|NCT00558064|O2|Outcome|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
1101507|NCT00558064|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
1101508|NCT00558064|E2|Reported Event|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
1101509|NCT00558064|E1|Reported Event|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
1101510|NCT00558025|B3|Baseline|Total|Total of all reporting groups
1101511|NCT00558025|B2|Baseline|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
1101512|NCT00558025|B1|Baseline|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
1101513|NCT00558025|P2|Participant Flow|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
1101514|NCT00558025|P1|Participant Flow|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d. (Quaque die, once per day), per os
1101515|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
1101516|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
1101517|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
1101518|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
1101519|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
1101520|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
1101521|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
1101522|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
1101523|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
1101524|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
1101525|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
1101526|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
1101527|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
1101528|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
1101529|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
1101530|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
1101531|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
1101532|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
1101533|NCT00558025|E2|Reported Event|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
1101534|NCT00558025|E1|Reported Event|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
1101535|NCT00558012|B3|Baseline|Total|Total of all reporting groups
1101536|NCT00558012|B2|Baseline|Placebo|"Placebo~Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
1101537|NCT00558012|B1|Baseline|Active Medication Group|"One-time dose: Intravenous Zoledronic Acid 5.0 mg~Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
1101539|NCT00558012|P1|Participant Flow|Active Medication Group|"One-time dose: Intravenous Zoledronic Acid 5.0 mg~Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
1101540|NCT00558012|O2|Outcome|Placebo|"Placebo~Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
1101541|NCT00558012|O1|Outcome|Active Medication Group|"One-time dose: Intravenous Zoledronic Acid 5.0 mg~Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
1101542|NCT00558012|E2|Reported Event|Placebo|"Placebo~Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
1101543|NCT00558012|E1|Reported Event|Active Medication Group|"One-time dose: Intravenous Zoledronic Acid 5.0 mg~Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
1101544|NCT00557947|B1|Baseline|Dermabond Protape/Suture|Dermabond Protape-Incision segments are randomized & patient is own control. Incision segments are randomized such that each patient receives Dermabond Protape to close one side of the incision and Intradermal Sutures to close the other side of the incision. Protape is supplied as a single use mesh device with sufficient adhesive to saturate mesh. Sutures were not supplied.
1101545|NCT00557947|P1|Participant Flow|Dermabond Protape/Suture|Dermabond Protape-Incision segments are randomized & patient is own control. Incision segments are randomized such that each patient receives Dermabond Protape to close one side of the incision and Intradermal Sutures to close the other side of the incision. Protape is supplied as a single use mesh device with sufficient adhesive to saturate mesh. Sutures were not supplied.
1101546|NCT00557947|O2|Outcome|Suture|Suture - Incision segments are randomized & patient is own control.
1101547|NCT00557947|O1|Outcome|Dermabond Protape|Dermabond Protape-Incision segments are randomized & patient is own control
1101548|NCT00557947|O2|Outcome|Suture|Suture - Incision segments are randomized & patient is own control.
1101549|NCT00557947|O1|Outcome|Dermabond Protape|Dermabond Protape-Incision segments are randomized & patient is own control
1101550|NCT00557947|O2|Outcome|Suture|Suture - Incision segments are randomized & patient is own control.
1101551|NCT00557947|O1|Outcome|Dermabond Protape|Dermabond Protape-Incision segments are randomized & patient is own control
1101552|NCT00557947|O2|Outcome|Suture|Suture - Incision segments are randomized & patient is own control.
1101553|NCT00557947|O1|Outcome|Dermabond Protape|Dermabond Protape-Incision segments are randomized & patient is own control
1101554|NCT00557947|O2|Outcome|Suture|Suture - Incision segments are randomized & patient is own control.
1101555|NCT00557947|O1|Outcome|Dermabond Protape|Dermabond Protape-Incision segments are randomized & patient is own control
1101556|NCT00557947|E4|Reported Event|Unrelated|Reported events per local regulatory requirements but not related to either device or procedure.
1101557|NCT00557947|E3|Reported Event|Procedure|
1101558|NCT00557947|E2|Reported Event|Suture|Suture - Incision segments are randomized & patient is own control.
1101559|NCT00557947|E1|Reported Event|Dermabond Protape|Dermabond Protape-Incision segments are randomized & patient is own control
1101560|NCT00557856|B1|Baseline|PF-03446962|All participants who received PF-03446962 intravenous infusion (0.5 milligram/kilogram [mg/kg], 1 mg/kg, 2 mg, 3 mg/kg, 4.5 mg/kg, 6.75 mg/kg, 10 mg/kg, 15 mg/kg, 7 mg/kg), on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression or unacceptable toxicity.
1101561|NCT00557856|P9|Participant Flow|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101562|NCT00557856|P8|Participant Flow|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101563|NCT00557856|P7|Participant Flow|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101564|NCT00557856|P6|Participant Flow|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101565|NCT00557856|P5|Participant Flow|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101566|NCT00557856|P4|Participant Flow|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101567|NCT00557856|P3|Participant Flow|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101568|NCT00557856|P2|Participant Flow|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101569|NCT00557856|P1|Participant Flow|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101570|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101571|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101572|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101708|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101573|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101574|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101575|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101576|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101577|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101578|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101579|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101580|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1102545|NCT00556400|B1|Baseline|Lo-ovral|1 tablet of lo-ovral is administered twice a day
1101581|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101582|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101583|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101584|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101585|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101586|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101587|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101588|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101589|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101590|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101591|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101592|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101593|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101594|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101595|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101596|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101597|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101598|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101599|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101874|NCT00557622|O1|Outcome|Placebo|Placebo once daily (OD)
1101600|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101601|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101602|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101603|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101604|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101605|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101606|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101607|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101608|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101609|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101610|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101611|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101612|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101613|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101614|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101615|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101616|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101617|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101618|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101619|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101620|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101621|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101622|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101623|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101624|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101625|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101626|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1103630|NCT00554216|P3|Participant Flow|VI-0521 Top|PHEN/TPM 15 mg/92 mg
1101627|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101628|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101629|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101630|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101631|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101632|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101633|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101634|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101635|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101636|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101637|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101638|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101639|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101640|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101641|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101642|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101643|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101644|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101645|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101646|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101647|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101648|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101649|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101650|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101651|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101652|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101653|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1103631|NCT00554216|P2|Participant Flow|VI-0521 Low|PHEN/TPM 3.75 mg/23 mg
1101654|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101655|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101656|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101657|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101658|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101659|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101660|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101661|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101662|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101663|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101664|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101665|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101666|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101667|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101668|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101669|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101670|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101671|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101672|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101673|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101674|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101675|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101676|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101677|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101678|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101679|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101680|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1103632|NCT00554216|P1|Participant Flow|Placebo|
1101681|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101682|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101683|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101684|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101685|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101686|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101687|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101688|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101689|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101690|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101691|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101692|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101693|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101694|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101695|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101696|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101697|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101698|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101699|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101700|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101701|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101702|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101703|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101704|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101705|NCT00557856|O1|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101706|NCT00557856|O1|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101707|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1103633|NCT00554216|O3|Outcome|VI-0521 Top|PHEN/TPM 15 mg/92 mg
1101709|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101710|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101711|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101712|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101713|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101714|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101715|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101716|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101717|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101718|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101719|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101720|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101721|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101722|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101723|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101724|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101725|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101726|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101727|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101728|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101729|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101730|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101731|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101732|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101733|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101734|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101735|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1103634|NCT00554216|O2|Outcome|VI-0521 Low|PHEN/TPM 3.75 mg/23 mg
1101736|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101737|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101738|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101739|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101740|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101741|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101742|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101743|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101744|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101745|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101746|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101747|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101748|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101749|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101750|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101751|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101752|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101753|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101754|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101755|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101756|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101757|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101758|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101759|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101760|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
1101761|NCT00557856|O1|Outcome|PF-03446962|All participants who received PF-03446962 intravenous infusion (0.5 milligram/kilogram [mg/kg], 1 mg/kg, 2 mg, 3 mg/kg, 4.5 mg/kg, 6.75 mg/kg, 10 mg/kg, 15 mg/kg), on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression or unacceptable toxicity.
1101907|NCT00557505|P3|Participant Flow|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1103635|NCT00554216|O1|Outcome|Placebo|
1101762|NCT00557856|O1|Outcome|PF-03446962|All participants who received PF-03446962 intravenous infusion (0.5 milligram/kilogram [mg/kg], 1 mg/kg, 2 mg, 3 mg/kg, 4.5 mg/kg, 6.75 mg/kg, 10 mg/kg, 15 mg/kg), on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression or unacceptable toxicity.
1101763|NCT00557856|E1|Reported Event|PF-03446962|All participants who received PF-03446962 intravenous infusion (0.5 milligram/kilogram [mg/kg], 1 mg/kg, 2 mg, 3 mg/kg, 4.5 mg/kg, 6.75 mg/kg, 10 mg/kg, 15 mg/kg, 7 mg/kg), on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression or unacceptable toxicity.
1101764|NCT00557830|B4|Baseline|Total|Total of all reporting groups
1101765|NCT00557830|B3|Baseline|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.~Sorafenib Standard Dose :~Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
1101766|NCT00557830|B2|Baseline|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.~Sorafenib Escalated Dose :~Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
1102546|NCT00556400|P2|Participant Flow|Sugar Pill|
1101767|NCT00557830|B1|Baseline|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
1101768|NCT00557830|P3|Participant Flow|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.~Sorafenib Standard Dose :~Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
1101769|NCT00557830|P2|Participant Flow|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.~Sorafenib Escalated Dose :~Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
1101770|NCT00557830|P1|Participant Flow|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
1101771|NCT00557830|O3|Outcome|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.~Sorafenib Standard Dose :~Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
1101772|NCT00557830|O2|Outcome|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.~Sorafenib Escalated Dose :~Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
1101773|NCT00557830|O1|Outcome|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
1101774|NCT00557830|O3|Outcome|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.~Sorafenib Standard Dose :~Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
1102317|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1.
1101775|NCT00557830|O2|Outcome|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.~Sorafenib Escalated Dose :~Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
1101776|NCT00557830|O1|Outcome|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
1101777|NCT00557830|O3|Outcome|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.~Sorafenib Standard Dose :~Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
1102547|NCT00556400|P1|Participant Flow|Lo-ovral|1 tablet of lo-ovral is administered twice a day
1101778|NCT00557830|O2|Outcome|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.~Sorafenib Escalated Dose :~Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
1101779|NCT00557830|O1|Outcome|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
1101780|NCT00557830|O3|Outcome|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.~Sorafenib Standard Dose :~Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
1101781|NCT00557830|O2|Outcome|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.~Sorafenib Escalated Dose :~Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
1101782|NCT00557830|O1|Outcome|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
1101783|NCT00557830|O3|Outcome|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.~Sorafenib Standard Dose :~Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
1101784|NCT00557830|O2|Outcome|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.~Sorafenib Escalated Dose :~Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
1101785|NCT00557830|O1|Outcome|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
1101908|NCT00557505|P2|Participant Flow|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101786|NCT00557830|E3|Reported Event|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.~Sorafenib Standard Dose :~Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
1101787|NCT00557830|E2|Reported Event|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.~Sorafenib Escalated Dose :~Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
1101788|NCT00557830|E1|Reported Event|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
1101790|NCT00556712|B2|Baseline|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101791|NCT00556712|B1|Baseline|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101792|NCT00556712|P2|Participant Flow|Erlotinib, 150 Milligrams Per Day (mg/Day)|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101793|NCT00556712|P1|Participant Flow|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) were randomized to receive a placebo, orally (PO) as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101794|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101795|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101796|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101797|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101798|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101799|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1102131|NCT00557466|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1101800|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101801|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101802|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101803|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101804|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101805|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101806|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101807|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101808|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101809|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101810|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101811|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101812|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101813|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101909|NCT00557505|P1|Participant Flow|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 milligram per kilogram (mg/kg) intravenously (IV) administered over 1 hour (hr) on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101814|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101815|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101816|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101817|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1102548|NCT00556400|O2|Outcome|Sugar Pill|
1101818|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101819|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101820|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101821|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101822|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101823|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101824|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101825|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101826|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101827|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101910|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1102411|NCT00556673|B3|Baseline|Total|Total of all reporting groups
1101828|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101829|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101830|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101831|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101832|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101833|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101834|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101835|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101836|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101837|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101838|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101839|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101840|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101841|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101911|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1103636|NCT00554216|O3|Outcome|VI-0521 Top|PHEN/TPM 15 mg/92 mg
1101842|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101843|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101844|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101845|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101846|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101847|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101848|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101849|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101850|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101851|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101852|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101853|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101854|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101855|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101912|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1103637|NCT00554216|O2|Outcome|VI-0521 Low|PHEN/TPM 3.75 mg/23 mg
1101856|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101857|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101858|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101859|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101860|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101861|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101862|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101863|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101864|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101865|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101866|NCT00556712|E2|Reported Event|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101867|NCT00556712|E1|Reported Event|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
1101868|NCT00557622|B3|Baseline|Total|Total of all reporting groups
1101869|NCT00557622|B2|Baseline|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
1101870|NCT00557622|B1|Baseline|Placebo|Placebo once daily (OD)
1101871|NCT00557622|P2|Participant Flow|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
1101872|NCT00557622|P1|Participant Flow|Placebo|Placebo once daily (OD)
1101873|NCT00557622|O2|Outcome|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
1101875|NCT00557622|O2|Outcome|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
1101876|NCT00557622|O1|Outcome|Placebo|Placebo once daily (OD)
1101877|NCT00557622|O2|Outcome|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
1101878|NCT00557622|O1|Outcome|Placebo|Placebo once daily (OD)
1101879|NCT00557622|O2|Outcome|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
1101880|NCT00557622|O1|Outcome|Placebo|Placebo once daily (OD)
1101881|NCT00557622|O2|Outcome|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
1101882|NCT00557622|O1|Outcome|Placebo|Placebo once daily (OD)
1101921|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1101883|NCT00557622|O2|Outcome|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
1101884|NCT00557622|O1|Outcome|Placebo|Placebo once daily (OD)
1101885|NCT00557622|O2|Outcome|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
1101886|NCT00557622|O1|Outcome|Placebo|Placebo once daily (OD)
1101887|NCT00557622|O2|Outcome|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
1101888|NCT00557622|O1|Outcome|Placebo|Placebo once daily (OD)
1101889|NCT00557622|E2|Reported Event|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
1101890|NCT00557622|E1|Reported Event|Placebo|Placebo once daily (OD)
1101891|NCT00557505|B10|Baseline|Total|Total of all reporting groups
1101892|NCT00557505|B9|Baseline|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1101893|NCT00557505|B8|Baseline|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1101894|NCT00557505|B7|Baseline|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1101895|NCT00557505|B6|Baseline|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101896|NCT00557505|B5|Baseline|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101897|NCT00557505|B4|Baseline|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101898|NCT00557505|B3|Baseline|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101899|NCT00557505|B2|Baseline|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101900|NCT00557505|B1|Baseline|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101901|NCT00557505|P9|Participant Flow|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1101902|NCT00557505|P8|Participant Flow|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1101903|NCT00557505|P7|Participant Flow|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1101904|NCT00557505|P6|Participant Flow|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101905|NCT00557505|P5|Participant Flow|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101906|NCT00557505|P4|Participant Flow|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101913|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101914|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101915|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101916|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101917|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101918|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101919|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1101920|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1105859|NCT00549939|O3|Outcome|Alfuzosin 0.2 mg/kg/Day|
1101922|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101923|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101924|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101925|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101926|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101927|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101928|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1101929|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1101930|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1101931|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101932|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101933|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101934|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101935|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101936|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101937|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1101938|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1101939|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1101940|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101941|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101942|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101943|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101944|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1103638|NCT00554216|O1|Outcome|Placebo|
1101945|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101946|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1101947|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1101948|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1101949|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101950|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101951|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101952|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101953|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101954|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101955|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1101956|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1101957|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1101958|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101959|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101960|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101961|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101962|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101963|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101964|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1101965|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1101966|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1101967|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101968|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101969|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101970|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101971|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101972|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101973|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1101974|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1101975|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1102755|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
1101976|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101977|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101978|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101979|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101980|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101981|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101982|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1101983|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1101984|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1101985|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101986|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101987|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101988|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101989|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101990|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101991|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1101992|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1101993|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1101994|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101995|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101996|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101997|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101998|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1101999|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102000|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1102001|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1102002|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1102003|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102004|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102005|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102006|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102756|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
1102007|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102008|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102009|NCT00557505|O3|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1102010|NCT00557505|O2|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1102011|NCT00557505|O1|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1102012|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1102013|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1102014|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1102015|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102016|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102017|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102018|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102019|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102020|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102021|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1102022|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1102023|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1102024|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102025|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102026|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102027|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102028|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102029|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102030|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1102031|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1102032|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1102033|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102034|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102035|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102036|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102037|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102757|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
1102038|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102039|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102040|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102041|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102042|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102043|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102044|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102102|NCT00557466|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102045|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1102046|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1102047|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1102048|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102049|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102050|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102051|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102052|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102053|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102054|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1102055|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1102056|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1102057|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102058|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102059|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102060|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102061|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102062|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102063|NCT00557505|E9|Reported Event|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1102064|NCT00557505|E8|Reported Event|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1102065|NCT00557505|E7|Reported Event|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
1102066|NCT00557505|E6|Reported Event|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102067|NCT00557505|E5|Reported Event|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102068|NCT00557505|E4|Reported Event|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1103639|NCT00554216|E3|Reported Event|VI-0521 Top|PHEN/TPM 15/92
1102069|NCT00557505|E3|Reported Event|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102070|NCT00557505|E2|Reported Event|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102071|NCT00557505|E1|Reported Event|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
1102072|NCT00557492|B1|Baseline|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
1102073|NCT00557492|P1|Participant Flow|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
1102103|NCT00557466|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102074|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
1102075|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
1102076|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
1102077|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
1102078|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
1102079|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
1102080|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
1102081|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
1102082|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
1102083|NCT00557492|E1|Reported Event|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
1102084|NCT00557466|B7|Baseline|Total|Total of all reporting groups
1102085|NCT00557466|B6|Baseline|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102086|NCT00557466|B5|Baseline|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
1102087|NCT00557466|B4|Baseline|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102088|NCT00557466|B3|Baseline|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102089|NCT00557466|B2|Baseline|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102090|NCT00557466|B1|Baseline|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102091|NCT00557466|P6|Participant Flow|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102092|NCT00557466|P5|Participant Flow|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
1102093|NCT00557466|P4|Participant Flow|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102094|NCT00557466|P3|Participant Flow|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102293|NCT00557245|E2|Reported Event|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
1102095|NCT00557466|P2|Participant Flow|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102096|NCT00557466|P1|Participant Flow|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102097|NCT00557466|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102098|NCT00557466|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
1102099|NCT00557466|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102100|NCT00557466|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102101|NCT00557466|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102104|NCT00557466|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
1102105|NCT00557466|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102106|NCT00557466|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102107|NCT00557466|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102108|NCT00557466|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102109|NCT00557466|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102110|NCT00557466|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
1102111|NCT00557466|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102112|NCT00557466|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102113|NCT00557466|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102114|NCT00557466|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102115|NCT00557466|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102116|NCT00557466|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
1102117|NCT00557466|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102118|NCT00557466|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102119|NCT00557466|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102120|NCT00557466|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102121|NCT00557466|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102122|NCT00557466|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
1102123|NCT00557466|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102124|NCT00557466|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102125|NCT00557466|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102126|NCT00557466|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102127|NCT00557466|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102128|NCT00557466|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
1102129|NCT00557466|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102130|NCT00557466|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102132|NCT00557466|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102133|NCT00557466|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102134|NCT00557466|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
1102135|NCT00557466|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102136|NCT00557466|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102137|NCT00557466|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102138|NCT00557466|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102139|NCT00557466|E6|Reported Event|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102140|NCT00557466|E5|Reported Event|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
1102141|NCT00557466|E4|Reported Event|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102142|NCT00557466|E3|Reported Event|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102143|NCT00557466|E2|Reported Event|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102144|NCT00557466|E1|Reported Event|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1102145|NCT00557440|B4|Baseline|Total|Total of all reporting groups
1102146|NCT00557440|B3|Baseline|Pbo - Ind/M - FP/Salm|"In Treatment Period 1 (Days 1 & 2) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 2 (Days 8 & 9) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 3 (Days 15 & 16) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.~Each treatment period was separated by a 6-day washout period."
1102147|NCT00557440|B2|Baseline|FP/Salm - Pbo - Ind/M|"In Treatment Period 1 (Days 1 & 2) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 2 (Days 8 & 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 3 (Days 15 & 16) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~Each treatment period was separated by a 6-day washout period."
1102148|NCT00557440|B1|Baseline|Ind/M - FP/Salm - Pbo|"In Treatment Period 1 (Days 1 & 2) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.~In Treatment Period 2 (Days 8 & 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone /salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 3 (Days 15 & 16) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~Each treatment period was separated by a 6-day washout period."
1102149|NCT00557440|P3|Participant Flow|Pbo - Ind/M - FP/Salm|"In Treatment Period 1 (Days 1 & 2) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 2 (Days 8 & 9) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 3 (Days 15 & 16) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.~Each treatment period was separated by a 6-day washout period."
1102150|NCT00557440|P2|Participant Flow|FP/Salm - Pbo - Ind/M|"In Treatment Period 1 (Days 1 & 2) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 2 (Days 8 & 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 3 (Days 15 & 16) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~Each treatment period was separated by a 6-day washout period."
1102151|NCT00557440|P1|Participant Flow|Ind/M - FP/Salm - Pbo|"In Treatment Period 1 (Days 1 & 2) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.~In Treatment Period 2 (Days 8 & 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone /salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 3 (Days 15 & 16) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~Each treatment period was separated by a 6-day washout period."
1102152|NCT00557440|O3|Outcome|Placebo|Participants received placebo to indacaterol/mometasone via the TWISTHALER device and placebo to fluticasone/salmeterol via MDDPI.
1102153|NCT00557440|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
1102154|NCT00557440|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening.
1102155|NCT00557440|O3|Outcome|Placebo|Participants received placebo to indacaterol/mometasone via the TWISTHALER device and placebo to fluticasone/salmeterol via MDDPI.
1105860|NCT00549939|O2|Outcome|Alfuzosin 0.1 mg/kg/Day|
1102156|NCT00557440|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
1102157|NCT00557440|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening.
1102158|NCT00557440|O3|Outcome|Placebo|Participants received placebo to indacaterol/mometasone via the TWISTHALER device and placebo to fluticasone/salmeterol via MDDPI.
1102159|NCT00557440|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
1102160|NCT00557440|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening.
1102161|NCT00557440|O3|Outcome|Placebo|Participants received placebo to indacaterol/mometasone via the TWISTHALER device and placebo to fluticasone/salmeterol via MDDPI.
1102162|NCT00557440|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
1102163|NCT00557440|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening.
1102164|NCT00557440|O3|Outcome|Placebo|Participants received placebo to indacaterol/mometasone via the TWISTHALER device and placebo to fluticasone/salmeterol via MDDPI.
1102165|NCT00557440|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
1102166|NCT00557440|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening.
1102167|NCT00557440|E3|Reported Event|Placebo|Participants received placebo to indacaterol/mometasone via the TWISTHALER device and placebo to fluticasone/salmeterol via MDDPI.
1102168|NCT00557440|E2|Reported Event|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
1102169|NCT00557440|E1|Reported Event|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening.
1102170|NCT00557362|B5|Baseline|Total|Total of all reporting groups
1102171|NCT00557362|B4|Baseline|Topical Natamycin Without Corneal De-epithelialization|Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
1102172|NCT00557362|B3|Baseline|Topical Natamycin With Corneal De-epithelialization|"Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.~Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications."
1102173|NCT00557362|B2|Baseline|Topical Voriconazole Without Corneal De-epithelialization|Drug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
1102174|NCT00557362|B1|Baseline|Topical Voriconazole With Corneal De-epithelialization|"Drug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake~Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications."
1102175|NCT00557362|P4|Participant Flow|Topical Voriconazole Without Corneal De-epithelialization|"Topical voriconazole without corneal de-epithelialization.~Drug: Voriconazole Voriconazole prepared as a 1% solution.~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
1102176|NCT00557362|P3|Participant Flow|Topical Voriconazole With Corneal De-epithelialization|"Topical voriconazole with corneal de-epithelialization.~Drug: Voriconazole Voriconazole prepared as a 1% solution.~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.~Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications."
1102241|NCT00557284|O1|Outcome|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
1102177|NCT00557362|P2|Participant Flow|Topical Natamycin Without Corneal De-epithelialization|"Topical natamycin without corneal de-epithelialization.~Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
1102178|NCT00557362|P1|Participant Flow|Topical Natamycin With Corneal De-epithelialization|"Topical natamycin with corneal de-epithelialization.~Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.~Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications."
1102179|NCT00557362|O2|Outcome|Topical Natamycin|"Drug: Natamycin 5%~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
1102180|NCT00557362|O1|Outcome|Topical Voriconazole|"Drug: Voriconazole~Voriconazole prepared as a 1% solution.~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
1102181|NCT00557362|O2|Outcome|Topical Natamycin|"Drug: Natamycin 5%~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
1102182|NCT00557362|O1|Outcome|Topical Voriconazole|"Drug: Voriconazole~Voriconazole prepared as a 1% solution.~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
1102549|NCT00556400|O1|Outcome|Lo-ovral|1 tablet of lo-ovral is administered twice a day
1102183|NCT00557362|O2|Outcome|Topical Natamycin|"Drug: Natamycin 5%~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.~Note that 5 patients in the natamycin arm had home visits conducted as their 3 month follow-up visit and scar size was not able to be obtained for these patients so they are not included in these analyses."
1102184|NCT00557362|O1|Outcome|Topical Voriconazole|"Drug: Voriconazole~Voriconazole prepared as a 1% solution.~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.~Note that 9 patients in the voriconazole arm had home visits conducted as their 3 month follow-up visit and scar size was not able to be obtained for these patients so they are not included in these analyses."
1102185|NCT00557362|O2|Outcome|Topical Natamycin|"Drug: Natamycin 5%~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake"
1102186|NCT00557362|O1|Outcome|Topical Voriconazole|"Drug: Voriconazole~Voriconazole prepared as a 1% solution.~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake"
1102187|NCT00557362|O2|Outcome|Topical Natamycin|"Drug: Natamycin 5%~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
1102188|NCT00557362|O1|Outcome|Topical Voriconazole|"Drug: Voriconazole Voriconazole prepared as a 1% solution.~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
1102189|NCT00557362|E4|Reported Event|Topical Natamycin Without Corneal De-epithelialization|Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
1102190|NCT00557362|E3|Reported Event|Topical Natamycin With Corneal De-epithelialization|"Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.~Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications."
1102191|NCT00557362|E2|Reported Event|Topical Voriconazole Without Corneal De-epithelialization|Drug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
1102192|NCT00557362|E1|Reported Event|Topical Voriconazole With Corneal De-epithelialization|"Drug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.~Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications."
1102193|NCT00557349|B3|Baseline|Total|Total of all reporting groups
1102194|NCT00557349|B2|Baseline|Famotidine|40 mg daily for 14 weeks
1102195|NCT00557349|B1|Baseline|Omeprazole|40 mg daily for 14 weeks
1102196|NCT00557349|P2|Participant Flow|Famotidine|40 mg daily at bedtime for 14 weeks
1102197|NCT00557349|P1|Participant Flow|Omeprazole|40 mg daily at bedtime for 14 weeks
1102198|NCT00557349|O2|Outcome|Famotidine|40 mg daily at bedtime for 14 weeks
1102199|NCT00557349|O1|Outcome|Omeprazole|40 mg daily at bedtime for 14 weeks
1102200|NCT00557349|O2|Outcome|Famotidine|40 mg daily at bedtime for 14 weeks
1102201|NCT00557349|O1|Outcome|Omeprazole|40 mg daily at bedtime for 14 weeks
1102202|NCT00557349|E2|Reported Event|Famotidine|40 mg daily for 14 weeks
1102203|NCT00557349|E1|Reported Event|Omeprazole|40 mg daily for 14 weeks
1102204|NCT00557323|B1|Baseline|5-Year Observational Period|Followed subjects previously exposed to lanthanum carbonate in study SPD405-309 (NCT00150540). Subjects were not issued investigational medicinal product. Subjects could be treated for hyperphosphatemia as prescribed by their physician during the study, although this was not required for participation. Treatment was not restricted by the protocol, and it could include treatment with lanthanum carbonate or any other phosphate binder as prescribed by the treating physician. Subjects were assessed every 6 months throughout the 5-year observational period. Data were collected on bone-related adverse events, serious adverse events and deaths.
1102205|NCT00557323|P1|Participant Flow|5-Year Observational Period|Followed subjects previously exposed to lanthanum carbonate in study SPD405-309 (NCT00150540). Subjects were not issued investigational medicinal product. Subjects could be treated for hyperphosphatemia as prescribed by their physician during the study, although this was not required for participation. Treatment was not restricted by the protocol, and it could include treatment with lanthanum carbonate or any other phosphate binder as prescribed by the treating physician. Subjects were assessed every 6 months throughout the 5-year observational period. Data were collected on bone-related adverse events, serious adverse events and deaths.
1102242|NCT00557284|O2|Outcome|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
1102206|NCT00557323|O1|Outcome|5-Year Observational Period|Followed subjects previously exposed to lanthanum carbonate in study SPD405-309 (NCT00150540). Subjects were not issued investigational medicinal product. Subjects could be treated for hyperphosphatemia as prescribed by their physician during the study, although this was not required for participation. Treatment was not restricted by the protocol, and it could include treatment with lanthanum carbonate or any other phosphate binder as prescribed by the treating physician. Subjects were assessed every 6 months throughout the 5-year observational period. Data were collected on bone-related adverse events, serious adverse events and deaths.
1102207|NCT00557323|O1|Outcome|5-Year Observational Period|Followed subjects previously exposed to lanthanum carbonate in study SPD405-309 (NCT00150540). Subjects were not issued investigational medicinal product. Subjects could be treated for hyperphosphatemia as prescribed by their physician during the study, although this was not required for participation. Treatment was not restricted by the protocol, and it could include treatment with lanthanum carbonate or any other phosphate binder as prescribed by the treating physician. Subjects were assessed every 6 months throughout the 5-year observational period. Data were collected on bone-related adverse events, serious adverse events and deaths.
1102251|NCT00557284|E1|Reported Event|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
1102252|NCT00557245|B4|Baseline|Total|Total of all reporting groups
1102550|NCT00556400|O2|Outcome|Sugar Pill|
1102208|NCT00557323|E1|Reported Event|5-Year Observational Period|Followed subjects previously exposed to lanthanum carbonate in study SPD405-309 (NCT00150540). Subjects were not issued investigational medicinal product. Subjects could be treated for hyperphosphatemia as prescribed by their physician during the study, although this was not required for participation. Treatment was not restricted by the protocol, and it could include treatment with lanthanum carbonate or any other phosphate binder as prescribed by the treating physician. Subjects were assessed every 6 months throughout the 5-year observational period. Data were collected on bone-related adverse events, serious adverse events and deaths.
1102209|NCT00557310|B1|Baseline|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
1102210|NCT00557310|P1|Participant Flow|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
1102211|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
1102212|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
1102213|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
1102214|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
1102215|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
1102216|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
1102217|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
1102218|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
1102219|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
1102220|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
1102221|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
1102222|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
1102223|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
1102224|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
1102225|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
1102226|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
1102227|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
1102228|NCT00557310|E1|Reported Event|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
1102229|NCT00557284|B3|Baseline|Total|Total of all reporting groups
1102230|NCT00557284|B2|Baseline|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
1102231|NCT00557284|B1|Baseline|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
1102232|NCT00557284|P2|Participant Flow|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
1102233|NCT00557284|P1|Participant Flow|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
1102234|NCT00557284|O2|Outcome|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
1102235|NCT00557284|O1|Outcome|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
1102236|NCT00557284|O2|Outcome|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
1102237|NCT00557284|O1|Outcome|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
1102238|NCT00557284|O2|Outcome|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
1102239|NCT00557284|O1|Outcome|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
1102240|NCT00557284|O2|Outcome|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
1102243|NCT00557284|O1|Outcome|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
1102244|NCT00557284|O2|Outcome|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
1102245|NCT00557284|O1|Outcome|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
1102246|NCT00557284|O2|Outcome|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
1102247|NCT00557284|O1|Outcome|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
1102248|NCT00557284|O2|Outcome|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
1102249|NCT00557284|O1|Outcome|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
1102250|NCT00557284|E2|Reported Event|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
1102253|NCT00557245|B3|Baseline|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
1102254|NCT00557245|B2|Baseline|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
1102255|NCT00557245|B1|Baseline|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
1102256|NCT00557245|P3|Participant Flow|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
1102257|NCT00557245|P2|Participant Flow|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
1102258|NCT00557245|P1|Participant Flow|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
1102259|NCT00557245|O3|Outcome|Placebo|Placebo TDF + Placebo FTC/TDF orally, once daily.
1102260|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
1102261|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|Tenofovir Disoproxil Fumarate (TDF): TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
1102262|NCT00557245|O3|Outcome|Placebo|Placebo TDF + Placebo FTC/TDF orally, once daily.
1102263|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
1102264|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|Tenofovir Disoproxil Fumarate (TDF): TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
1102265|NCT00557245|O3|Outcome|Placebo|Placebo TDF + Placebo FTC/TDF orally, once daily.
1102266|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
1102267|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|Tenofovir Disoproxil Fumarate (TDF): TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
1102268|NCT00557245|O3|Outcome|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
1102269|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
1102270|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
1102271|NCT00557245|O3|Outcome|Placebo|Placebo TDF + Placebo FTC/TDF orally, once daily.
1102272|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
1102273|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|Tenofovir Disoproxil Fumarate (TDF): TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
1102274|NCT00557245|O3|Outcome|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
1102275|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
1102276|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
1102277|NCT00557245|O3|Outcome|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
1102278|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
1102279|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
1102280|NCT00557245|O3|Outcome|Placebo|Placebo TDF + Placebo FTC/TDF orally, once daily.
1102281|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
1102282|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|Tenofovir Disoproxil Fumarate (TDF): TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
1102283|NCT00557245|O3|Outcome|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
1102284|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
1102285|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
1102286|NCT00557245|O3|Outcome|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
1102287|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
1102288|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
1102289|NCT00557245|O3|Outcome|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
1102290|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
1102291|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
1102294|NCT00557245|E1|Reported Event|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
1102295|NCT00557076|B3|Baseline|Total|Total of all reporting groups
1102296|NCT00557076|B2|Baseline|Sham|"sham auditory stimulation~Sham Auditory Stimulation: The sham intervention is zero minutes of Familiar Voice Stimulation. Each day for 6 weeks 0 minutes of Familiar voice stimulation will be provided in 10 minute daily segments for 6 weeks. Each 10 minute recording is a digital recording of silence."
1102297|NCT00557076|B1|Baseline|FAST|"high dose of familiar voice stimulation~Familiar Voice Stimulation High Dose: The High Dose intervention is 1,680 minutes of Familiar Vocal Stimulation (FVs) provided in 40 minute daily segments at least 2 hours apart and for 6 weeks. Four CDs with 10 minutes of FVs preceded by the familiar voice calling out the subject's name, will be played (1 at a time) each day for 6 weeks providing 1,680 minutes of FVs."
1102298|NCT00557076|P2|Participant Flow|Sham|"sham auditory stimulation~Sham Auditory Stimulation: The sham intervention is zero minutes of Familiar Voice Stimulation. Each day for 6 weeks 0 minutes of Familiar voice stimulation will be provided in 10 minute daily segments for 6 weeks. Each 10 minute recording is a digital recording of silence."
1102323|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).
1102299|NCT00557076|P1|Participant Flow|FAST|"high dose of familiar voice stimulation~Familiar Voice Stimulation High Dose: The High Dose intervention is 1,680 minutes of Familiar Vocal Stimulation (FVs) provided in 40 minute daily segments at least 2 hours apart and for 6 weeks. Four CDs with 10 minutes of FVs preceded by the familiar voice calling out the subject's name, will be played (1 at a time) each day for 6 weeks providing 1,680 minutes of FVs."
1102300|NCT00557076|O2|Outcome|Sham|"sham auditory stimulation~Sham Auditory Stimulation: The sham intervention is zero minutes of Familiar Voice Stimulation. Each day for 6 weeks 0 minutes of Familiar voice stimulation will be provided in 10 minute daily segments for 6 weeks. Each 10 minute recording is a digital recording of silence."
1102301|NCT00557076|O1|Outcome|FAST|"high dose of familiar voice stimulation~Familiar Voice Stimulation High Dose: The High Dose intervention is 1,680 minutes of Familiar Vocal Stimulation (FVs) provided in 40 minute daily segments at least 2 hours apart and for 6 weeks. Four CDs with 10 minutes of FVs preceded by the familiar voice calling out the subject's name, will be played (1 at a time) each day for 6 weeks providing 1,680 minutes of FVs."
1102302|NCT00557076|O2|Outcome|Sham|"sham auditory stimulation~Sham Auditory Stimulation: The sham intervention is zero minutes of Familiar Voice Stimulation. Each day for 6 weeks 0 minutes of Familiar voice stimulation will be provided in 10 minute daily segments for 6 weeks. Each 10 minute recording is a digital recording of silence."
1102303|NCT00557076|O1|Outcome|FAST|"high dose of familiar voice stimulation~Familiar Voice Stimulation High Dose: The High Dose intervention is 1,680 minutes of Familiar Vocal Stimulation (FVs) provided in 40 minute daily segments at least 2 hours apart and for 6 weeks. Four CDs with 10 minutes of FVs preceded by the familiar voice calling out the subject's name, will be played (1 at a time) each day for 6 weeks providing 1,680 minutes of FVs."
1102304|NCT00557076|E2|Reported Event|Sham|"sham auditory stimulation~Sham Auditory Stimulation: The sham intervention is zero minutes of Familiar Voice Stimulation. Each day for 6 weeks 0 minutes of Familiar voice stimulation will be provided in 10 minute daily segments for 6 weeks. Each 10 minute recording is a digital recording of silence."
1102305|NCT00557076|E1|Reported Event|FAST|"high dose of familiar voice stimulation~Familiar Voice Stimulation High Dose: The High Dose intervention is 1,680 minutes of Familiar Vocal Stimulation (FVs) provided in 40 minute daily segments at least 2 hours apart and for 6 weeks. Four CDs with 10 minutes of FVs preceded by the familiar voice calling out the subject's name, will be played (1 at a time) each day for 6 weeks providing 1,680 minutes of FVs."
1102306|NCT00556998|B1|Baseline|All Treatments|Voriconazole intravenous (IV) loading dose (6 mg/kg) was administered in the morning and evening on Day 1, and the IV maintenance dose (4 mg/kg) was administered in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated). The oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
1102307|NCT00556998|P1|Participant Flow|All Treatments|Voriconazole intravenous (IV) loading dose (6 mg/kg) was administered in the morning and evening on Day 1, and the IV maintenance dose (4 mg/kg) was administered in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated). The oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
1102308|NCT00556998|O1|Outcome|Voriconazole Oral|Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
1102309|NCT00556998|O1|Outcome|Voriconazole Oral|Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
1102310|NCT00556998|O1|Outcome|Voriconazole Oral|Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
1102311|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).
1102312|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).
1102313|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).
1102314|NCT00556998|O1|Outcome|All Treatments|Voriconazole intravenous (IV) loading dose (6 mg/kg) was administered in the morning and evening on Day 1, and the IV maintenance dose (4 mg/kg) was administered in the morning and evening on Days 2-7 (up to Day 20 if clinically indicated). The oral maintenance dosing regimen was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
1102315|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1.
1102316|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1.
1102318|NCT00556998|O1|Outcome|Voriconazole Oral|Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
1102319|NCT00556998|O1|Outcome|Voriconazole Oral|Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
1102320|NCT00556998|O1|Outcome|Voriconazole Oral|Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
1102321|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).
1102322|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).
1102551|NCT00556400|O1|Outcome|Lo-ovral|1 tablet of lo-ovral is administered twice a day
1102324|NCT00556998|E2|Reported Event|Voriconazole Oral|Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
1102325|NCT00556998|E1|Reported Event|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).
1102326|NCT00556972|B1|Baseline|Fecal Incontinence Management System|The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.
1102327|NCT00556972|P1|Participant Flow|Fecal Incontinence Management System|The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.
1102328|NCT00556972|O1|Outcome|Fecal Incontinence Management System|The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.
1102329|NCT00556972|O1|Outcome|Fecal Incontinence Management System|The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.
1102330|NCT00556972|O1|Outcome|Fecal Incontinence Management System|The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.
1102331|NCT00556972|O1|Outcome|Fecal Incontinence Management System|The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.
1102332|NCT00556972|E1|Reported Event|Fecal Incontinence Management System|The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.
1102333|NCT00556946|B1|Baseline|Combined Photodynamic and Pulsed Dye Laser Treatment|Treatment of Port Wine Stains using Combined Photodynamic and Pulsed Dye Laser.
1102334|NCT00556946|P1|Participant Flow|Combined Photodynamic and Pulsed Dye Laser Treatment|Treatment of Port Wine Stains: using Combined Photodynamic and Pulsed Dye Laser.
1102335|NCT00556946|O1|Outcome|Treatment of Port Wine Stains|"Treatment of Port Wine Stains~Treatment of Port Wine Stains: Treatment of Port Wine Stains"
1102336|NCT00556946|E1|Reported Event|Treatment of Port Wine Stains|"Treatment of Port Wine Stains~Treatment of Port Wine Stains: Treatment of Port Wine Stains"
1102337|NCT00556933|B5|Baseline|Total|Total of all reporting groups
1102338|NCT00556933|B4|Baseline|Divided-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofeti|"Kidney transplant receive the same treatment as in Group 2, until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.~Sirolimus, oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~Tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.."
1102339|NCT00556933|B3|Baseline|Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant receive the same treatment as in Group 1, until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.~Sirolimus, oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~Tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
1102340|NCT00556933|B2|Baseline|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant patients receive 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6. Chronic maintenance immunosuppression is with tacrolimus and sirolimus.~Sirolimus, oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~Tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
1102443|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
1102444|NCT00556673|O3|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
1103640|NCT00554216|E2|Reported Event|VI-0521 Low|PHEN/TPM 3.75/23
1102341|NCT00556933|B1|Baseline|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|"Kidney transplant patients receive 6 mg/kg of rATG as a single dose administered intravenously over <24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation. Chronic maintenance immunosuppression is with tacrolimus and sirolimus.~Sirolimus, oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~Tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
1102342|NCT00556933|P4|Participant Flow|Divided-dose rATG (1.5mg/kgx4),Sirolimus/Mycophenolate Mofetil|Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG, 1.5 mg/kg x 4) and maintained on tacrolimus and sirolimus for chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
1102448|NCT00556673|E2|Reported Event|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
1102495|NCT00556491|E1|Reported Event|Minocycline|minocycline: given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses
1102343|NCT00556933|P3|Participant Flow|Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG, 6 mg/kg x 1) and maintained on tacrolimus and sirolimus for chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
1102344|NCT00556933|P2|Participant Flow|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|Kidney transplant recipients given 4 small doses (1.5 mg/kg) of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
1102345|NCT00556933|P1|Participant Flow|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) (6 mg/kg) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
1102346|NCT00556933|O4|Outcome|Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
1102347|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
1102348|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
1102349|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
1102350|NCT00556933|O4|Outcome|Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
1102412|NCT00556673|B2|Baseline|Placebo - Indacaterol/Mometasone|In Treatment Period 1 (Day 1) participants received 2 inhalations of placebo in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of indacaterol maleate 250 μg/mometasone furoate 200 μg via the Twisthaler device in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg/salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.
1102445|NCT00556673|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
1102351|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
1102496|NCT00556478|B3|Baseline|Total|Total of all reporting groups
1102552|NCT00556400|O2|Outcome|Sugar Pill|
1102352|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
1102353|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
1102354|NCT00556933|O4|Outcome|Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
1102355|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
1102356|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
1102357|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
1102358|NCT00556933|O4|Outcome|Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.~mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough leve"
1102359|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and i"
1102360|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
1102361|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
1102362|NCT00556933|O4|Outcome|Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
1102363|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
1102364|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
1102365|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
1102366|NCT00556933|O4|Outcome|Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
1102758|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
1102367|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
1102368|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
1102369|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
1102370|NCT00556933|O4|Outcome|Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
1102371|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
1102372|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
1102373|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
1102374|NCT00556933|O4|Outcome|Divided-dose rATG(1.5mg/kgx4), Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
1102670|NCT00555997|B1|Baseline|Placebo/Ziprasidone|Received placebo in first phase and ziprasidone in second phase
1102375|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
1102376|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
1102377|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
1102378|NCT00556933|O4|Outcome|Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
1102379|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
1102380|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
1102381|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
1102382|NCT00556933|O4|Outcome|Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
1102671|NCT00555997|P4|Participant Flow|Phase 2 Placebo|Patients who received placebo in phase 2.
1102383|NCT00556933|O3|Outcome|Ingle-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
1102384|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
1102385|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
1102386|NCT00556933|O4|Outcome|Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.~mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough leve"
1102387|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and i"
1102388|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
1102389|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
1102390|NCT00556933|O4|Outcome|Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
1102391|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
1102392|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
1102393|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
1102394|NCT00556933|E4|Reported Event|Group 4|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.~mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough leve"
1102395|NCT00556933|E3|Reported Event|Group 3|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and i"
1102396|NCT00556933|E2|Reported Event|Group 2|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
1102397|NCT00556933|E1|Reported Event|Group 1|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
1102398|NCT00556894|B4|Baseline|Total|Total of all reporting groups
1102399|NCT00556894|B3|Baseline|Placebo|CF101: orally q12h
1102400|NCT00556894|B2|Baseline|CF101 1mg|CF101: orally q12h
1102401|NCT00556894|B1|Baseline|CF101 0.1mg|CF101: orally q12h
1102402|NCT00556894|P3|Participant Flow|Placebo|Matching placebo
1102403|NCT00556894|P2|Participant Flow|CF101 1mg|CF101 1mg orally q12 for 12 weeks
1102404|NCT00556894|P1|Participant Flow|CF101 0.1mg|CF101 0.1mg orally q12 for 12 weeks
1102405|NCT00556894|O3|Outcome|Placebo|
1102406|NCT00556894|O2|Outcome|CF101 1mg|
1102407|NCT00556894|O1|Outcome|CF101 0.1mg|
1102408|NCT00556894|E3|Reported Event|Placebo|Matching Placebo q12 for 12 weeks
1102409|NCT00556894|E2|Reported Event|CF101 1mg|CF101 1mg q12 for 12 weeks
1102410|NCT00556894|E1|Reported Event|CF101 0.1mg|CF101 0.1mg q12 for 12 weeks
1102413|NCT00556673|B1|Baseline|Indacaterol/Mometasone - Placebo|In Treatment Period 1 (Day 1) participants received 2 inhalations of indacaterol maleate 250 μg/mometasone furoate 200 μg once a day in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of placebo via the Twisthaler device once a day in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg/salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.
1102449|NCT00556673|E1|Reported Event|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
1102450|NCT00556543|B1|Baseline|All Study Subjects|
1102451|NCT00556543|P1|Participant Flow|All Study Subjects|
1102452|NCT00556543|O1|Outcome|All Study Subjects|
1102414|NCT00556673|P2|Participant Flow|Placebo - Indacaterol/Mometasone|In Treatment Period 1 (Day 1) participants received 2 inhalations of placebo in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of indacaterol maleate 250 μg/mometasone furoate 200 μg via the Twisthaler device in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg/salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.
1102415|NCT00556673|P1|Participant Flow|Indacaterol/Mometasone - Placebo|In Treatment Period 1 (Day 1) participants received 2 inhalations of indacaterol maleate 250 μg/mometasone furoate 200 μg once a day in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of placebo via the Twisthaler device once a day in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg/salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.
1102416|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
1102417|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
1102418|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
1102419|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
1102420|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
1102421|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
1102422|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
1102423|NCT00556673|O3|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
1102424|NCT00556673|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
1102425|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
1102426|NCT00556673|O3|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
1102427|NCT00556673|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
1102428|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
1102429|NCT00556673|O3|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
1102430|NCT00556673|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
1102431|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
1102432|NCT00556673|O3|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
1102433|NCT00556673|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
1102434|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
1102435|NCT00556673|O3|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
1102436|NCT00556673|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
1102437|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
1102438|NCT00556673|O3|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
1102439|NCT00556673|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
1102440|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
1102441|NCT00556673|O3|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
1102442|NCT00556673|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
1103641|NCT00554216|E1|Reported Event|Placebo|
1102446|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
1102447|NCT00556673|E3|Reported Event|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
1102453|NCT00556543|O1|Outcome|All Study Subjects|
1102454|NCT00556543|O1|Outcome|All Study Subjects|
1102462|NCT00556543|O2|Outcome|Rib Fracture Repair for Persistent Rib Fracture Non-Union|Subjects had CT scan evidence of rib fracture non-union at least 3 months from injury date. Subjects were a median of 41.5 months (range 9 – 56 months) post-injury at the time of repair.
1102463|NCT00556543|O1|Outcome|Acute Rib Fracture Repair|These 6 patients with acute injury underwent rib fracture repair a median of 11 days (range 4 – 18 days) post-injury.
1102464|NCT00556543|E2|Reported Event|Chronic Rib Fracture Non-union Repair|
1102465|NCT00556543|E1|Reported Event|Acute Rib Fracture Repair|
1102466|NCT00556504|B3|Baseline|Total|Total of all reporting groups
1102467|NCT00556504|B2|Baseline|Placebo|Placebo with convetional treatment for HCV patients
1102468|NCT00556504|B1|Baseline|TCM-700C|TCM-700C, an add-on drug to conventional treatment of Hepatitis C
1102469|NCT00556504|P2|Participant Flow|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
1102470|NCT00556504|P1|Participant Flow|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
1102471|NCT00556504|O2|Outcome|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
1102472|NCT00556504|O1|Outcome|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
1102473|NCT00556504|O2|Outcome|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
1102474|NCT00556504|O1|Outcome|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
1102475|NCT00556504|O2|Outcome|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
1102476|NCT00556504|O1|Outcome|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
1102477|NCT00556504|O2|Outcome|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
1102478|NCT00556504|O1|Outcome|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
1102479|NCT00556504|O2|Outcome|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
1102480|NCT00556504|O1|Outcome|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
1102481|NCT00556504|O2|Outcome|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
1102482|NCT00556504|O1|Outcome|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
1102483|NCT00556504|O2|Outcome|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
1102484|NCT00556504|O1|Outcome|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
1102485|NCT00556504|E2|Reported Event|Placebo (Safety Population)|Placebo with convetional treatment(PegIFN plus RBV) for HCV patients
1102486|NCT00556504|E1|Reported Event|TCM-700C (Safety Population)|TCM-700C, an add-on drug to conventional treatment(PegIFN plus RBV)of Hepatitis C
1102487|NCT00556491|B3|Baseline|Total|Total of all reporting groups
1102488|NCT00556491|B2|Baseline|Placebo|placebo: placebo will be given for at least 4 doses pre-op to a maximum of 14 doses
1102489|NCT00556491|B1|Baseline|Minocycline|minocycline: given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses
1102490|NCT00556491|P2|Participant Flow|Placebo|placebo: placebo will be given for at least 4 doses pre-op to a maximum of 14 doses
1102491|NCT00556491|P1|Participant Flow|Minocycline|minocycline: given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses
1102492|NCT00556491|O2|Outcome|Placebo|
1102493|NCT00556491|O1|Outcome|Minocycline|
1102494|NCT00556491|E2|Reported Event|Placebo|placebo: placebo will be given for at least 4 doses pre-op to a maximum of 14 doses
1102497|NCT00556478|B2|Baseline|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502 Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the PSD502 spray and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
1102498|NCT00556478|B1|Baseline|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
1102499|NCT00556478|P2|Participant Flow|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502 Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the PSD502 spray and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
1102500|NCT00556478|P1|Participant Flow|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
1102501|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.~Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
1102502|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
1102503|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.~Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
1102504|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
1102542|NCT00556426|E1|Reported Event|All Patients Receiving the Filter|All enrolled subjects
1102543|NCT00556400|B3|Baseline|Total|Total of all reporting groups
1102505|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.~Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
1102506|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
1102507|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.~Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
1102508|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
1102509|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.~Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
1102510|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
1102672|NCT00555997|P3|Participant Flow|Phase 2 Ziprasidone|Subjects taking ziprasidone in the second phase.
1102673|NCT00555997|P2|Participant Flow|Phase 1 Placebo|Subjects taking placebo in the first phase.
1102674|NCT00555997|P1|Participant Flow|Phase 1 Ziprasidone|Subjects taking ziprasidone in the first phase.
1102511|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.~Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
1102512|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
1102513|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.~Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
1102514|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
1102515|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.~Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
1102516|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
1102517|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502 Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the PSD502 spray and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
1102518|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
1102675|NCT00555997|O4|Outcome|Phase 2 Placebo|Patients who received placebo in phase 2.
1102676|NCT00555997|O3|Outcome|Phase 2 Ziprasidone|Subjects taking ziprasidone in the second phase.
1102519|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502 Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the PSD502 spray and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
1102520|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
1102521|NCT00556478|E3|Reported Event|Open Label Phase|"Subjects will all receive PSD502 if they wish to continue in the trial.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
1102522|NCT00556478|E2|Reported Event|Double-Blind Placebo|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502 Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the PSD502 spray and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
1102523|NCT00556478|E1|Reported Event|Double-Blind Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
1102524|NCT00556452|B4|Baseline|Total|Total of all reporting groups
1102525|NCT00556452|B3|Baseline|Clo/BU4 40mg/m^2|"Clofarabine/Busulfan x 4 : Clofarabine IV 40 mg/m^2/day x 5 days~Busulfan IV 3.2 mg/kg daily x 4 days~Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment."
1102526|NCT00556452|B2|Baseline|Clo/BU4 30mg/m^2|"Clofarabine/Busulfan x 4 : Clofarabine IV 30 mg/m^2/day x 5 days~Busulfan IV 3.2 mg/kg daily x 4 days~Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment."
1102527|NCT00556452|B1|Baseline|Clo/BU4 20mg/m^2|"Clofarabine/Busulfan x 4 : Clofarabine IV 20 mg/m^2/day x 5 days~Busulfan IV 3.2 mg/kg daily x 4 days~Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment."
1102528|NCT00556452|P3|Participant Flow|Clo/BU4 40mg/m^2|"Clofarabine/Busulfan x 4 : Clofarabine IV 40 mg/m^2/day x 5 days~Busulfan IV 3.2 mg/kg daily x 4 days~Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment."
1102529|NCT00556452|P2|Participant Flow|Clo/BU4 30mg/m^2|"Clofarabine/Busulfan x 4 : Clofarabine IV 30 mg/m^2/day x 5 days~Busulfan IV 3.2 mg/kg daily x 4 days~Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment."
1102530|NCT00556452|P1|Participant Flow|Clo/BU4 20mg/m^2|"Clofarabine/Busulfan x 4 : Clofarabine IV 20 mg/m^2/day x 5 days~Busulfan IV 3.2 mg/kg daily x 4 days~Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment."
1102531|NCT00556452|O1|Outcome|Clo/BU4|"Study will start at the 2nd dose level of three Clofarabine levels, in combination with Busulfan. The Clofarabine level that each subsequent patient is treated at is determined by a method using continual reassessment.~After pre-conditioning, subjects will receive a peripheral blood stem cell transplant.~Total Lymphoid Irradiation : Total Lymphoid Irradiation (TLI) of 4 Gy, if cord blood transplant~Clofarabine/Busulfan x 4 : Clofarabine IV (dose levels)~1st dose level: 20 mg/m2/day x 5 days~2nd dose level: 30 mg/m2/day x 5 days~3rd dose level: 40 mg/m2/day x 5 days~Busulfan IV 3.2 mg/kg daily x 4 days~Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment"
1102677|NCT00555997|O2|Outcome|Phase 1 Placebo|Subjects taking placebo in the first phase.
1102678|NCT00555997|O1|Outcome|Phase 1 Ziprasidone|Subjects taking ziprasidone in the first phase.
1102679|NCT00555997|O4|Outcome|Placebo Phase II|Results from phase II for those taking placebo during that phase
1102532|NCT00556452|O1|Outcome|Clo/BU4|"Study will start at the 2nd dose level of three Clofarabine levels, in combination with Busulfan. The Clofarabine level that each subsequent patient is treated at is determined by a method using continual reassessment.~After pre-conditioning, subjects will receive a peripheral blood stem cell transplant.~Total Lymphoid Irradiation : Total Lymphoid Irradiation (TLI) of 4 Gy, if cord blood transplant~Clofarabine/Busulfan x 4 : Clofarabine IV (dose levels)~1st dose level: 20 mg/m2/day x 5 days~2nd dose level: 30 mg/m2/day x 5 days~3rd dose level: 40 mg/m2/day x 5 days~Busulfan IV 3.2 mg/kg daily x 4 days~Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment"
1102533|NCT00556452|O1|Outcome|Clo/Bu4|Experimental: Clo/BU4
1102534|NCT00556452|E1|Reported Event|Clo/Bu4|
1102535|NCT00556426|B1|Baseline|Participants Receiving a Filter|Patients who were at temporary, increased risk of pulmonary embolism requiring inferior vena cava (IVC) interruption, and for whom Recovery G2 Filter retrieval could reasonably be expected to occur within 6 months of device placement.
1102536|NCT00556426|P1|Participant Flow|All Patients Receiving the Filter|All enrolled subjects
1102537|NCT00556426|O1|Outcome|Fractured Filters|retrieval of the filter such that the entire filter is retrieved
1102538|NCT00556426|O1|Outcome|All Patients Receiving the Filter|All enrolled subjects
1102539|NCT00556426|O1|Outcome|All Patients Receiving the Filter|All enrolled subjects
1102540|NCT00556426|O1|Outcome|All Patients Receiving the Filter|All enrolled subjects
1102541|NCT00556426|O1|Outcome|All Patients Receiving the Filter|All enrolled subjects
1102544|NCT00556400|B2|Baseline|Sugar Pill|
1102553|NCT00556400|O1|Outcome|Lo-ovral|1 tablet of lo-ovral is administered twice a day
1102554|NCT00556400|E1|Reported Event|Sugar Pill|
1102555|NCT00556374|B3|Baseline|Total|Total of all reporting groups
1102556|NCT00556374|B2|Baseline|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
1102557|NCT00556374|B1|Baseline|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
1102558|NCT00556374|P2|Participant Flow|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
1102559|NCT00556374|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy (AIT).
1102560|NCT00556374|O2|Outcome|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
1102561|NCT00556374|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
1102562|NCT00556374|O2|Outcome|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
1102563|NCT00556374|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
1102564|NCT00556374|O2|Outcome|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
1102565|NCT00556374|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
1102566|NCT00556374|O2|Outcome|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
1102567|NCT00556374|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
1102568|NCT00556374|O2|Outcome|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
1102569|NCT00556374|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
1102570|NCT00556374|O2|Outcome|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
1102571|NCT00556374|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
1102572|NCT00556374|E2|Reported Event|Denosumab 60mg Q6M|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy
1102573|NCT00556374|E1|Reported Event|Placebo Q6M|Participants received placebo subcutaneous injection once every 6 months (Q6M). All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
1102574|NCT00556322|B3|Baseline|Total|Total of all reporting groups
1102575|NCT00556322|B2|Baseline|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
1102576|NCT00556322|B1|Baseline|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
1102577|NCT00556322|P2|Participant Flow|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
1102578|NCT00556322|P1|Participant Flow|Comparator|Participants received either pemetrexed 500 milligrams per square meter (mg/m^2) every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
1102579|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
1102580|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
1102581|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
1102780|NCT00555750|P2|Participant Flow|Placebo|nightly placebo (identical tablet to active medication) oral administration ~30 min before bed
1106426|NCT00548691|B3|Baseline|Total|Total of all reporting groups
1102582|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
1102583|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
1102584|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
1102585|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
1102586|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
1102587|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
1102588|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
1102589|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
1102590|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
1102591|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
1102680|NCT00555997|O3|Outcome|Ziprasidone Phase II|Results from phase II for those taking ziprasidone during that phase
1102681|NCT00555997|O2|Outcome|Placebo Phase I|Results from phase I for those taking placebo during that phase
1102682|NCT00555997|O1|Outcome|Ziprasidone Phase I|Results from phase I for those taking ziprasidone during that phase
1102683|NCT00555997|O4|Outcome|Placebo Phase II|Results from phase II for those taking placebo during that phase
1102592|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
1102593|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
1102594|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
1102595|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
1102596|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
1102597|NCT00556322|O2|Outcome|Erlotinib|Participants received a single oral dose of erlotinib 150 mg/day as a tablet until disease progression, unacceptable toxicity or death.
1106926|NCT00546871|O4|Outcome|Study Part 3b, SC Administration|
1102598|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
1102599|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
1102600|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable t oxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
1102601|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
1102602|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
1102603|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
1102604|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
1102605|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
1102606|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
1102607|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
1102684|NCT00555997|O3|Outcome|Ziprasidone Phase II|Results from phase II for those taking ziprasidone during that phase
1102685|NCT00555997|O2|Outcome|Placebo Phase I|Results from phase I for those taking placebo during that phase
1102686|NCT00555997|O1|Outcome|Ziprasidone Phase I|Results from phase I for those taking ziprasidone during that phase
1102687|NCT00555997|E2|Reported Event|Placebo|Adverse events experienced when taking placebo
1104119|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
1102608|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
1102609|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
1102610|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
1102611|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
1102612|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel l75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
1102613|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
1102614|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
1102615|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
1102616|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
1102617|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
1102618|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
1102619|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
1102620|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
1102621|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
1102622|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
1102623|NCT00556322|E2|Reported Event|Erlotinib|Participants received a single oral dose of erlotinib 150 mg/day until disease progression, unacceptable toxicity or death.
1102688|NCT00555997|E1|Reported Event|Ziprasidone|Adverse events experienced by subjects while taking ziprasidone
1102689|NCT00555906|B4|Baseline|Total|Total of all reporting groups
1102759|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
1102760|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
1102761|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
1102624|NCT00556322|E1|Reported Event|Comparator|Participants received either Alimta 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or Taxotere 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, Taxotere was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
1102625|NCT00556166|B1|Baseline|Enterra Therapy|The Enterra Therapy Gastric Stimulator will be used on subjects who have failed all other medical options to treat gastroparesis and all have a gastric stimulator implanted.
1102626|NCT00556166|P1|Participant Flow|Enterra Therapy|The Enterra Therapy Gastric Stimulator will be used on subjects who have failed all other medical options to treat gastroparesis and all have a gastric stimulator implanted.
1102627|NCT00556166|O1|Outcome|Enterra Therapy|The Enterra Therapy Gastric Stimulator will be used on subjects who have failed all other medical options to treat gastroparesis and all have a gastric stimulator implanted.
1102628|NCT00556166|O1|Outcome|Enterra Therapy|The Enterra Therapy Gastric Stimulator will be used on subjects who have failed all other medical options to treat gastroparesis and all have a gastric stimulator implanted.
1102629|NCT00556166|E1|Reported Event|Enterra Therapy|The Enterra Therapy Gastric Stimulator will be used on subjects who have failed all other medical options to treat gastroparesis and all have a gastric stimulator implanted.
1102630|NCT00556140|B1|Baseline|Major Depression With Psychotic Features|All patients received aripiprazole 10 milligrams and escitalopram 10 milligrams as starting doses. These doses were increased to 20 milligrams and 30 milligrams, respectively. These increases occurred over a period of 7 weeks.
1102631|NCT00556140|P1|Participant Flow|Major Depression With Psychotic Features|All patients received aripiprazole 10 milligrams and escitalopram 10 milligrams as starting doses. These doses were increased to 20 milligrams and 30 milligrams, respectively. These increases occurred over a period of 7 weeks.
1102788|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
1102632|NCT00556140|O1|Outcome|Major Depression With Psychotic Features|All patients received aripiprazole 10 milligrams and escitalopram 10 milligrams as starting doses. These doses were increased to 20 milligrams and 30 milligrams, respectively. These increases occurred over a period of 7 weeks.
1102633|NCT00556140|O1|Outcome|Major Depression With Psychotic Features|All patients received aripiprazole 10 milligrams and escitalopram 10 milligrams as starting doses. These doses were increased to 20 milligrams and 30 milligrams, respectively. These increases occurred over a period of 7 weeks.
1102634|NCT00556140|E1|Reported Event|Major Depression With Psychotic Features|All patients received aripiprazole 10 milligrams and escitalopram 10 milligrams as starting doses. These doses were increased to 20 milligrams and 30 milligrams, respectively. These increases occurred over a period of 7 weeks.
1102635|NCT00556075|B4|Baseline|Total|Total of all reporting groups
1102636|NCT00556075|B3|Baseline|50 mg|Proellex 50 mg: 2 capsules daily for 4 months
1102637|NCT00556075|B2|Baseline|25 mg|Proellex 25 mg: 1 capsule daily for 4 months
1102638|NCT00556075|B1|Baseline|Placebo|Placebo: 1 capsule daily for 4 months
1102639|NCT00556075|P3|Participant Flow|B 50 mg|Proellex 50 mg: 2 capsules daily for 4 months
1102640|NCT00556075|P2|Participant Flow|A 25 mg|Proellex 25 mg: 1 capsule daily for 4 months
1102641|NCT00556075|P1|Participant Flow|C Placebo|Placebo: 1 capsule daily for 4 months
1102642|NCT00556075|O3|Outcome|50 mg|Proellex 50 mg: 2 capsules daily for 4 months
1102643|NCT00556075|O2|Outcome|25 mg|Proellex 25 mg: 1 capsule daily for 4 months
1102644|NCT00556075|O1|Outcome|Placebo|Placebo: 1 capsule daily for 4 months
1102645|NCT00556075|O3|Outcome|50 mg|Proellex 50 mg: 2 capsules daily for 4 months
1102646|NCT00556075|O2|Outcome|25 mg|Proellex 25 mg: 1 capsule daily for 4 months
1102647|NCT00556075|O1|Outcome|Placebo|Placebo: 1 capsule daily for 4 months
1102648|NCT00556075|O3|Outcome|50 mg|"Proellex 50 mg~Proellex 50 mg: 2 capsules daily for 4 months"
1102649|NCT00556075|O2|Outcome|25 mg|"Proellex 25 mg~Proellex 25 mg: 1 capsule daily for 4 months"
1102650|NCT00556075|O1|Outcome|Placebo|"Placebo~Placebo: 1 capsule daily for 4 months"
1102651|NCT00556075|O3|Outcome|50 mg|"Proellex 50 mg~Proellex 50 mg: 2 capsules daily for 4 months"
1102652|NCT00556075|O2|Outcome|25 mg|"Proellex 25 mg~Proellex 25 mg: 1 capsule daily for 4 months"
1102653|NCT00556075|O1|Outcome|Placebo|Placebo: 1capsule daily for 4 months
1102654|NCT00556075|O3|Outcome|50 mg|Proellex 50 mg: 2 capsules daily for 4 months
1102655|NCT00556075|O2|Outcome|25 mg|Proellex 25 mg: 1 capsule daily for 4 months
1102656|NCT00556075|O1|Outcome|Placebo|Placebo: 1 capsule daily for 4 months
1102657|NCT00556075|O3|Outcome|50 mg|Proellex 50 mg: 2 capsules daily for 4 months
1102658|NCT00556075|O2|Outcome|25 mg|Proellex 25 mg: 1 capsule daily for 4 months
1102659|NCT00556075|O1|Outcome|Placebo|Placebo: 1 capsule daily for 4 months
1102660|NCT00556075|E3|Reported Event|50 mg|Proellex 50 mg: 2 capsules daily for 4 months
1102661|NCT00556075|E2|Reported Event|25 mg|Proellex 25 mg: 1 capsule daily for 4 months
1102662|NCT00556075|E1|Reported Event|Placebo|Placebo: 1 capsule daily for 4 months
1102663|NCT00556049|B1|Baseline|Treatment|"Sunitinib and gemcitabine~Gemcitabine: Intravenously on days 1 and 8 of each 21-day treatment cycle.~Sunitinib: Orally on days 1-14 of each 21-day treatment cycle"
1102664|NCT00556049|P1|Participant Flow|Treatment|"Sunitinib and gemcitabine~Gemcitabine: Intravenously on days 1 and 8 of each 21-day treatment cycle.~Sunitinib: Orally on days 1-14 of each 21-day treatment cycle"
1102665|NCT00556049|O1|Outcome|Treatment|"Sunitinib and gemcitabine~Gemcitabine: Intravenously on days 1 and 8 of each 21-day treatment cycle.~Sunitinib: Orally on days 1-14 of each 21-day treatment cycle"
1102666|NCT00556049|E1|Reported Event|Neutropenia|"Sunitinib and gemcitabine~Gemcitabine: Intravenously on days 1 and 8 of each 21-day treatment cycle.~Sunitinib: Orally on days 1-14 of each 21-day treatment cycle"
1102667|NCT00555997|B4|Baseline|Total|Total of all reporting groups
1102668|NCT00555997|B3|Baseline|Ziprasidone|Subjects received ziprasidone throughout study
1102669|NCT00555997|B2|Baseline|Placebo|Subjects received placebo throughout study
1102690|NCT00555906|B3|Baseline|Palbociclib + Bortezomib + Dexamethasone (Phase2:ScheduleB)|Included all participants who received palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102691|NCT00555906|B2|Baseline|Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule B)|Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102781|NCT00555750|P1|Participant Flow|Eszopiclone|nightly active medication (eszopiclone, 3 mg tablet) oral administration ~30 min before bed
1102782|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
1102783|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
1102784|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
1106927|NCT00546871|O3|Outcome|Study Part 3a, SC Administration|
1102692|NCT00555906|B1|Baseline|Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)|Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102693|NCT00555906|P5|Participant Flow|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:ScheduleB)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102694|NCT00555906|P4|Participant Flow|Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102695|NCT00555906|P3|Participant Flow|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102696|NCT00555906|P2|Participant Flow|Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 75 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102762|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
1102763|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
1102764|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
1102765|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
1102766|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
1102697|NCT00555906|P1|Participant Flow|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 100 milligram (mg) capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 milligram per square meter (mg/m^2) intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102698|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1106928|NCT00546871|O2|Outcome|Study Part 2, SC Administration|
1102699|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102700|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102701|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102702|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102703|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102736|NCT00555893|E1|Reported Event|Active Drug|"Adults and adolescents weighing greater than 88 pounds will receive one 75 mg oseltamivir capsule twice daily, with or without food for a total of 5 days (10 doses). Participants one year of age and older up to a maximum weight of 88 pounds will receive a liquid form of study medication containing oseltamivir at a concentration of 15mg/ml. The dose will be based on weight:~for weight <=33 lbs, dose=30 mg, volume per dose (15mg/mL)=2 mL two times per day x 5 days (10 doses); for weight 34-51 lbs, dose=45 mg, volume per dose (15mg/mL)=3 mL two times per day x 5 days (10 doses); for weight 52-88 lbs, dose=60 mg, volume per dose (15mg/mL)= 4 mL two times per day x 5 days (10 doses)"
1102737|NCT00555880|B3|Baseline|Total|Total of all reporting groups
1102704|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102705|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102706|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102707|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102708|NCT00555906|O4|Outcome|Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102709|NCT00555906|O3|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102710|NCT00555906|O2|Outcome|Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 75 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102738|NCT00555880|B2|Baseline|Placebo/Midodrine|Participants received matching Placebo followed by a single oral dose of Midodrine HCl the next day
1102739|NCT00555880|B1|Baseline|Midodrine/Placebo|Participants received a single oral dose of Midodrine HCl followed by matching Placebo the next day
1102740|NCT00555880|P2|Participant Flow|Placebo/Midodrine|Participants received Placebo followed by a single oral dose of Midodrine HCl the next day
1102741|NCT00555880|P1|Participant Flow|Midodrine/Placebo|Participants received a single oral dose of Midodrine hydrochloride (HCl) followed by matching Placebo the next day
1102742|NCT00555880|O1|Outcome|All Participants|All randomized participants
1102711|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102712|NCT00555906|O4|Outcome|Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102713|NCT00555906|O3|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102714|NCT00555906|O2|Outcome|Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 75 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102715|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102716|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:ScheduleB)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102717|NCT00555906|O2|Outcome|Palbociclib + Bortezomib + Dexamethasone (Phase1:ScheduleB)|Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102743|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
1102744|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
1102745|NCT00555880|O1|Outcome|All Participants|All randomized participants
1102746|NCT00555880|O1|Outcome|All Participants|All randomized participants
1102747|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
1102748|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
1103642|NCT00554190|B1|Baseline|AdvaCoat and Merogel Injectable|AdvaCoat compared with Merogel Injectable
1102718|NCT00555906|O1|Outcome|Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)|Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102727|NCT00555893|B2|Baseline|Placebo|"Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day.~Placebo: Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day."
1102785|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
1102786|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
1102719|NCT00555906|O2|Outcome|Palbociclib + Bortezomib + Dexamethasone (Phase1:ScheduleB)|Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102720|NCT00555906|O1|Outcome|Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)|Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102721|NCT00555906|E5|Reported Event|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:ScheduleB)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102722|NCT00555906|E4|Reported Event|Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102723|NCT00555906|E3|Reported Event|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102724|NCT00555906|E2|Reported Event|Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 75 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102749|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
1102750|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
1102751|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
1102752|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
1102753|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
1102725|NCT00555906|E1|Reported Event|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
1102726|NCT00555893|B3|Baseline|Total|Total of all reporting groups
1102728|NCT00555893|B1|Baseline|Active Drug|"Adults and adolescents weighing greater than 88 pounds will receive one 75 mg oseltamivir capsule twice daily, with or without food for a total of 5 days (10 doses). Participants one year of age and older up to a maximum weight of 88 pounds will receive a liquid form of study medication containing oseltamivir at a concentration of 15mg/ml. The dose will be based on weight:~for weight <=33 lbs, dose=30 mg, volume per dose (15mg/mL)=2 mL two times per day x 5 days (10 doses); for weight 34-51 lbs, dose=45 mg, volume per dose (15mg/mL)=3 mL two times per day x 5 days (10 doses); for weight 52-88 lbs, dose=60 mg, volume per dose (15mg/mL)= 4 mL two times per day x 5 days (10 doses)"
1102729|NCT00555893|P2|Participant Flow|Placebo|"Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day.~Placebo: Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day."
1102730|NCT00555893|P1|Participant Flow|Active Drug|"Adults and adolescents weighing greater than 88 pounds will receive one 75 mg oseltamivir capsule twice daily, with or without food for a total of 5 days (10 doses). Participants one year of age and older up to a maximum weight of 88 pounds will receive a liquid form of study medication containing oseltamivir at a concentration of 15mg/ml. The dose will be based on weight:~for weight <=33 lbs, dose=30 mg, volume per dose (15mg/mL)=2 mL two times per day x 5 days (10 doses); for weight 34-51 lbs, dose=45 mg, volume per dose (15mg/mL)=3 mL two times per day x 5 days (10 doses); for weight 52-88 lbs, dose=60 mg, volume per dose (15mg/mL)= 4 mL two times per day x 5 days (10 doses)"
1102731|NCT00555893|O2|Outcome|Placebo|"Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day.~Placebo: Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day."
1102732|NCT00555893|O1|Outcome|Active Drug|"Adults and adolescents weighing greater than 88 pounds will receive one 75 mg oseltamivir capsule twice daily, with or without food for a total of 5 days (10 doses). Participants one year of age and older up to a maximum weight of 88 pounds will receive a liquid form of study medication containing oseltamivir at a concentration of 15mg/ml. The dose will be based on weight:~for weight <=33 lbs, dose=30 mg, volume per dose (15mg/mL)=2 mL two times per day x 5 days (10 doses); for weight 34-51 lbs, dose=45 mg, volume per dose (15mg/mL)=3 mL two times per day x 5 days (10 doses); for weight 52-88 lbs, dose=60 mg, volume per dose (15mg/mL)= 4 mL two times per day x 5 days (10 doses)"
1102733|NCT00555893|O2|Outcome|Placebo|"Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day.~Placebo: Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day."
1102734|NCT00555893|O1|Outcome|Active Drug|"Adults and adolescents weighing greater than 88 pounds will receive one 75 mg oseltamivir capsule twice daily, with or without food for a total of 5 days (10 doses). Participants one year of age and older up to a maximum weight of 88 pounds will receive a liquid form of study medication containing oseltamivir at a concentration of 15mg/ml. The dose will be based on weight:~for weight <=33 lbs, dose=30 mg, volume per dose (15mg/mL)=2 mL two times per day x 5 days (10 doses); for weight 34-51 lbs, dose=45 mg, volume per dose (15mg/mL)=3 mL two times per day x 5 days (10 doses); for weight 52-88 lbs, dose=60 mg, volume per dose (15mg/mL)= 4 mL two times per day x 5 days (10 doses)"
1102735|NCT00555893|E2|Reported Event|Placebo|"Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day.~Placebo: Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day."
1102754|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
1102767|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
1102768|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
1102769|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
1102770|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
1102771|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
1102772|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
1102773|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
1102774|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
1102775|NCT00555880|E2|Reported Event|Placebo/Midodrine|Participants received Placebo followed by a single oral dose of Midodrine HCl (10-30mg) the next day.
1102776|NCT00555880|E1|Reported Event|Midodrine/Placebo|Participants received a single oral dose of Midodrine HCl (10-30mg) followed by placebo the next day.
1102777|NCT00555750|B3|Baseline|Total|Total of all reporting groups
1102778|NCT00555750|B2|Baseline|Placebo|nightly administration of placebo before bed
1102779|NCT00555750|B1|Baseline|Active|active medication administration nightly before bed
1102787|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
1102789|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
1102790|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
1102791|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
1102792|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
1102793|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
1102794|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
1102795|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
1102796|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
1102797|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
1102798|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
1102799|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
1102800|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
1102801|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
1102802|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
1102803|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
1102804|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
1102805|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
1102806|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
1102807|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
1102808|NCT00555750|E2|Reported Event|Placebo|nightly administration of placebo before bed
1102809|NCT00555750|E1|Reported Event|Active|active medication administration nightly before bed
1102810|NCT00555672|B3|Baseline|Total|Total of all reporting groups
1102811|NCT00555672|B2|Baseline|Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
1102812|NCT00555672|B1|Baseline|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
1102813|NCT00555672|P2|Participant Flow|Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
1102814|NCT00555672|P1|Participant Flow|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
1102815|NCT00555672|O2|Outcome|Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
1102816|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
1104120|NCT00553267|O1|Outcome|Amlodipine 10mg|
1102817|NCT00555672|O2|Outcome|Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
1102818|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
1102819|NCT00555672|O2|Outcome|Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
1102820|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
1102821|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
1102822|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
1102874|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102823|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
1102824|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
1102825|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
1102826|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
1102827|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
1102828|NCT00555672|O2|Outcome|Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
1102829|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
1102830|NCT00555672|E2|Reported Event|Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
1102831|NCT00555672|E1|Reported Event|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
1102832|NCT00555620|B7|Baseline|Total|Total of all reporting groups
1102833|NCT00555620|B6|Baseline|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102834|NCT00555620|B5|Baseline|SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102835|NCT00555620|B4|Baseline|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102836|NCT00555620|B3|Baseline|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102837|NCT00555620|B2|Baseline|SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102838|NCT00555620|B1|Baseline|SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2|Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
1102839|NCT00555620|P6|Participant Flow|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102840|NCT00555620|P5|Participant Flow|SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102841|NCT00555620|P4|Participant Flow|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102842|NCT00555620|P3|Participant Flow|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102843|NCT00555620|P2|Participant Flow|SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102844|NCT00555620|P1|Participant Flow|SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2|Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
1102845|NCT00555620|O6|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102967|NCT00555568|O1|Outcome|Arm 1: Peer-led Group|Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
1102846|NCT00555620|O5|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102847|NCT00555620|O4|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102848|NCT00555620|O3|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102849|NCT00555620|O2|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102850|NCT00555620|O1|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2|Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
1102851|NCT00555620|O5|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102852|NCT00555620|O4|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102853|NCT00555620|O3|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102854|NCT00555620|O2|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102855|NCT00555620|O1|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2|Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
1102856|NCT00555620|O6|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102857|NCT00555620|O5|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102858|NCT00555620|O4|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102859|NCT00555620|O3|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102860|NCT00555620|O2|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102861|NCT00555620|O1|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2|Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
1102862|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102863|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102864|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1104121|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
1102865|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102866|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102867|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102868|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102869|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102870|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102871|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102872|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102873|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102968|NCT00555568|O3|Outcome|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
1102875|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102876|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102877|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102878|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102879|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102880|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102881|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102882|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102883|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102884|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102885|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102886|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102887|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102888|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102889|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102890|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102891|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102892|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102893|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102894|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1103003|NCT00555438|O1|Outcome|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
1102895|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102896|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102897|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102898|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102899|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102900|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102901|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102902|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102903|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102904|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102905|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102906|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102907|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102908|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102909|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102910|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102911|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102912|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102913|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102914|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102915|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102916|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102917|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102918|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102919|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102920|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102921|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102922|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102923|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102924|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1103004|NCT00555438|O1|Outcome|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
1102925|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102926|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102927|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102928|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102929|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102930|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102931|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102932|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102933|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102934|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102935|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102936|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102937|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102938|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102939|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102940|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102941|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102942|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102943|NCT00555620|O6|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102944|NCT00555620|O5|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102945|NCT00555620|O4|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102946|NCT00555620|O3|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102947|NCT00555620|O2|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102948|NCT00555620|O1|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2|Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
1102949|NCT00555620|E6|Reported Event|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102950|NCT00555620|E5|Reported Event|SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102951|NCT00555620|E4|Reported Event|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102952|NCT00555620|E3|Reported Event|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1102953|NCT00555620|E2|Reported Event|SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
1103005|NCT00555438|O1|Outcome|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
1102954|NCT00555620|E1|Reported Event|SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2|Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
1102955|NCT00555568|B4|Baseline|Total|Total of all reporting groups
1102956|NCT00555568|B3|Baseline|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
1102957|NCT00555568|B2|Baseline|Arm 2: Clinician-Led Group|"Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician~recovery-oriented mental health clinician-led group: This is a recovery-focused mental health education and support group led by a mental health clinician"
1102958|NCT00555568|B1|Baseline|Arm 1: Peer-Led Group|"Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators~recovery oriented mental health peer support group: This is a recovery-focused mental health education and support group led by peer facilitators"
1102959|NCT00555568|P3|Participant Flow|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
1102960|NCT00555568|P2|Participant Flow|Arm 2: Clinician Led Group|Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
1102961|NCT00555568|P1|Participant Flow|Arm 1: Peer-led Group|Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
1102962|NCT00555568|O3|Outcome|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
1102963|NCT00555568|O2|Outcome|Arm 2: Clinician-led Group|Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
1102964|NCT00555568|O1|Outcome|Arm 1: Peer-led Group|Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
1102965|NCT00555568|O3|Outcome|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
1102966|NCT00555568|O2|Outcome|Arm 2: Clinician-led Group|Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
1102969|NCT00555568|O2|Outcome|Arm 2: Clinician-led Group|Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
1102970|NCT00555568|O1|Outcome|Arm 1: Peer-led Group|Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
1102971|NCT00555568|O3|Outcome|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
1102972|NCT00555568|O2|Outcome|Arm 2: Clinician-led Group|Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
1102973|NCT00555568|O1|Outcome|Arm 1: Peer-led Group|Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
1102974|NCT00555568|O3|Outcome|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
1102975|NCT00555568|O2|Outcome|Arm 2: Clinician-led Group|Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
1102976|NCT00555568|O1|Outcome|Arm 1: Peer-led Group|Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
1102977|NCT00555568|E3|Reported Event|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
1102978|NCT00555568|E2|Reported Event|Arm 2: Clinician-led Group|Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
1102979|NCT00555568|E1|Reported Event|Arm 1: Peer-led Group|Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
1102980|NCT00555477|B3|Baseline|Total|Total of all reporting groups
1102981|NCT00555477|B2|Baseline|Anastrozole Part 2|Analysis of the first 18 subjects enrolled revealed a greater than expected discontinuation of AI therapy because of elevated serum estradiol concentrations. Discontinuation was believed to be primarily due to greater than expected variability in the assay as opposed to true recovery of ovarian function. Therefore, the protocol was amended. Subjects with an average baseline estradiol concentration of ≤20 pg/ml were considered eligible for part 2 and initiated treatment with anastrozole 1 mg orally daily.
1102982|NCT00555477|B1|Baseline|Anastrozole Part 1|In the initial version of the clinical trial (designated part 1), subjects were required to have serum estradiol and FSH concentrations within the postmenopausal range according to local institutional guidelines within 28 days of enrollment. Subjects taking tamoxifen at the time of screening were only required to have postmenopausal serum estradiol concentrations. Subjects were treated with anastrozole, 1 mg orally daily.
1102983|NCT00555477|P2|Participant Flow|Anastrozole Part 2|During the conduct of the trial the study was amended to change the eligibility criteria because of difficulties with the estradiol assay. Subjects enrolled after the amendment were required to sign consent and then have an average baseline estradiol concentration of ≤20 pg/ml in order to be considered eligible.
1102984|NCT00555477|P1|Participant Flow|Anastrozole Part 1|In the initial version of the clinical trial (designated part 1), subjects were required to have serum estradiol and FSH (Follicle-stimulating hormone) concentrations within the postmenopausal range according to local institutional guidelines within 28 days of enrollment. Subjects taking tamoxifen at the time of screening were only required to have postmenopausal serum estradiol concentrations. Subjects were treated with anastrozole, 1 mg orally daily.
1102985|NCT00555477|O2|Outcome|Anastrozole Part 2|Analysis of the first 18 subjects enrolled revealed a greater than expected discontinuation of AI therapy because of elevated serum estradiol concentrations. Discontinuation was believed to be primarily due to greater than expected variability in the assay as opposed to true recovery of ovarian function. Therefore, the protocol was amended. Subjects with an average baseline estradiol concentration of ≤20 pg/ml were considered eligible for part 2 and initiated treatment with anastrozole 1 mg orally daily.
1103006|NCT00555438|E1|Reported Event|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
1103007|NCT00555425|B3|Baseline|Total|Total of all reporting groups
1103373|NCT00555152|O3|Outcome|Arm III Lapatinib 750 mg|Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
1102986|NCT00555477|O1|Outcome|Anastrozole Part 1|In the initial version of the clinical trial (designated part 1), subjects were required to have serum estradiol and FSH concentrations within the postmenopausal range according to local institutional guidelines within 28 days of enrollment. Subjects taking tamoxifen at the time of screening were only required to have postmenopausal serum estradiol concentrations. Subjects were treated with anastrozole, 1 mg orally daily.
1102987|NCT00555477|E1|Reported Event|Anastrozole|anastrozole: 1 mg tablet by mouth once a day
1102988|NCT00555464|B3|Baseline|Total|Total of all reporting groups
1102989|NCT00555464|B2|Baseline|Oral Steroid Treatment Group|"The standard treatment for hemangioma at most centers is oral steroids (Prednisolone). Prednisolone has been used to stop the growth of infantile hemangiomas that are life threatening, that could harm important functions, or are likely to result in severe disfigurement (scarring) without treatment.~Prednisone : Prednisolone given at 3 mg/kg/day by mouth for 12 week"
1102990|NCT00555464|B1|Baseline|Vincristine Treatment Group|"Vincristine is a drug that has been used to treat cancers in children (including infants). It has been effective in treating a small number of infants with hemangiomas, most of whom failed previous therapies including steroids. Vincristine must be administered into a vein. Given the encouraging response data and documented safety record, Vincristine is a good choice for a clinical trial treating infants with complicated hemangiomas.~Vincristine : Vincristine (0.05 mg/kg/dose) will be administered into a vein (PICC line) every week for 12 weeks. If assigned to receive Vincristine, a PICC line will be placed by a doctor who is a specialist in this procedure, an interventional radiologist. This will require sedation and when possible, will be coordinated with sedation for the MRI."
1102991|NCT00555464|P2|Participant Flow|Oral Steroid Treatment Group|"The standard treatment for hemangioma at most centers is oral steroids (Prednisolone). Prednisolone has been used to stop the growth of infantile hemangiomas that are life threatening, that could harm important functions, or are likely to result in severe disfigurement (scarring) without treatment.~Prednisone : Prednisolone given at 3 mg/kg/day by mouth for 12 week"
1103033|NCT00555360|O2|Outcome|mHealth+Carepartner|Weekly IVR calls for 12 months+feedback to CarePartner
1103034|NCT00555360|O1|Outcome|Standard mHealth|Weekly IVR calls for 12 months
1103035|NCT00555360|O2|Outcome|mHealth+Carepartner|Weekly IVR calls for 12 months+feedback to CarePartner
1103036|NCT00555360|O1|Outcome|Standard mHealth|Weekly IVR calls for 12 months
1102992|NCT00555464|P1|Participant Flow|Vincristine Treatment Group|"Vincristine is a drug that has been used to treat cancers in children (including infants). It has been effective in treating a small number of infants with hemangiomas, most of whom failed previous therapies including steroids. Vincristine must be administered into a vein. Given the encouraging response data and documented safety record, Vincristine is a good choice for a clinical trial treating infants with complicated hemangiomas.~Vincristine : Vincristine (0.05 mg/kg/dose) will be administered into a vein (PICC line) every week for 12 weeks. If assigned to receive Vincristine, a PICC line will be placed by a doctor who is a specialist in this procedure, an interventional radiologist. This will require sedation and when possible, will be coordinated with sedation for the MRI."
1102993|NCT00555464|O2|Outcome|Oral Steroid Treatment Group|"The standard treatment for hemangioma at most centers is oral steroids (Prednisolone). Prednisolone has been used to stop the growth of infantile hemangiomas that are life threatening, that could harm important functions, or are likely to result in severe disfigurement (scarring) without treatment.~Prednisone : Prednisolone given at 3 mg/kg/day by mouth for 12 week"
1102994|NCT00555464|O1|Outcome|Vincristine Treatment Group|"Vincristine is a drug that has been used to treat cancers in children (including infants). It has been effective in treating a small number of infants with hemangiomas, most of whom failed previous therapies including steroids. Vincristine must be administered into a vein. Given the encouraging response data and documented safety record, Vincristine is a good choice for a clinical trial treating infants with complicated hemangiomas.~Vincristine : Vincristine (0.05 mg/kg/dose) will be administered into a vein (PICC line) every week for 12 weeks. If assigned to receive Vincristine, a PICC line will be placed by a doctor who is a specialist in this procedure, an interventional radiologist. This will require sedation and when possible, will be coordinated with sedation for the MRI."
1102995|NCT00555464|O2|Outcome|Oral Steroid Treatment Group|"The standard treatment for hemangioma at most centers is oral steroids (Prednisolone). Prednisolone has been used to stop the growth of infantile hemangiomas that are life threatening, that could harm important functions, or are likely to result in severe disfigurement (scarring) without treatment.~Prednisone : Prednisolone given at 3 mg/kg/day by mouth for 12 week"
1102996|NCT00555464|O1|Outcome|Vincristine Treatment Group|"Vincristine is a drug that has been used to treat cancers in children (including infants). It has been effective in treating a small number of infants with hemangiomas, most of whom failed previous therapies including steroids. Vincristine must be administered into a vein. Given the encouraging response data and documented safety record, Vincristine is a good choice for a clinical trial treating infants with complicated hemangiomas.~Vincristine : Vincristine (0.05 mg/kg/dose) will be administered into a vein (PICC line) every week for 12 weeks. If assigned to receive Vincristine, a PICC line will be placed by a doctor who is a specialist in this procedure, an interventional radiologist. This will require sedation and when possible, will be coordinated with sedation for the MRI."
1102997|NCT00555464|E2|Reported Event|Oral Steroid Treatment Group|"The standard treatment for hemangioma at most centers is oral steroids (Prednisolone). Prednisolone has been used to stop the growth of infantile hemangiomas that are life threatening, that could harm important functions, or are likely to result in severe disfigurement (scarring) without treatment.~Prednisone : Prednisolone given at 3 mg/kg/day by mouth for 12 week"
1102998|NCT00555464|E1|Reported Event|Vincristine Treatment Group|"Vincristine is a drug that has been used to treat cancers in children (including infants). It has been effective in treating a small number of infants with hemangiomas, most of whom failed previous therapies including steroids. Vincristine must be administered into a vein. Given the encouraging response data and documented safety record, Vincristine is a good choice for a clinical trial treating infants with complicated hemangiomas.~Vincristine : Vincristine (0.05 mg/kg/dose) will be administered into a vein (PICC line) every week for 12 weeks. If assigned to receive Vincristine, a PICC line will be placed by a doctor who is a specialist in this procedure, an interventional radiologist. This will require sedation and when possible, will be coordinated with sedation for the MRI."
1102999|NCT00555438|B1|Baseline|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
1103000|NCT00555438|P1|Participant Flow|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
1103001|NCT00555438|O1|Outcome|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
1103002|NCT00555438|O1|Outcome|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
1103008|NCT00555425|B2|Baseline|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
1103009|NCT00555425|B1|Baseline|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
1103010|NCT00555425|P2|Participant Flow|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
1103037|NCT00555360|O2|Outcome|mHealth+Carepartner|Weekly IVR calls for 12 months+CarePartner feedback
1103038|NCT00555360|O1|Outcome|Standard mHealth|Weekly IVR calls for 12 months
1103011|NCT00555425|P1|Participant Flow|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
1103012|NCT00555425|O2|Outcome|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
1103013|NCT00555425|O1|Outcome|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
1103014|NCT00555425|O2|Outcome|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
1103015|NCT00555425|O1|Outcome|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
1103016|NCT00555425|O2|Outcome|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
1103026|NCT00555425|E2|Reported Event|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
1103122|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103017|NCT00555425|O1|Outcome|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
1103018|NCT00555425|O2|Outcome|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
1103039|NCT00555360|E2|Reported Event|mHealth+Carepartner|Weekly IVR calls for 12 months+feedback to CarePartner
1103040|NCT00555360|E1|Reported Event|Standard mHealth|Weekly IVR calls for 12 months
1103041|NCT00555321|B6|Baseline|Total|Total of all reporting groups
1103042|NCT00555321|B5|Baseline|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1106929|NCT00546871|O1|Outcome|Study Part 1, IV Administration|
1103019|NCT00555425|O1|Outcome|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
1103020|NCT00555425|O2|Outcome|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
1103021|NCT00555425|O1|Outcome|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
1103022|NCT00555425|O2|Outcome|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
1103023|NCT00555425|O1|Outcome|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
1103024|NCT00555425|O2|Outcome|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
1103025|NCT00555425|O1|Outcome|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
1103056|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103027|NCT00555425|E1|Reported Event|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
1103028|NCT00555360|B3|Baseline|Total|Total of all reporting groups
1103029|NCT00555360|B2|Baseline|mHealth Plus CarePartner|Wkly IVR calls for 12 months+feedback to CarePartner
1103030|NCT00555360|B1|Baseline|Standard mHealth|Weekly IVR calls for 12 months
1103031|NCT00555360|P2|Participant Flow|mHealth Plus CarePartner|Wkly IVR calls for 12 months+feedback to CarePartner
1103032|NCT00555360|P1|Participant Flow|Standard mHealth|Weekly IVR calls for 12 months
1103043|NCT00555321|B4|Baseline|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103044|NCT00555321|B3|Baseline|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103045|NCT00555321|B2|Baseline|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103046|NCT00555321|B1|Baseline|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103047|NCT00555321|P5|Participant Flow|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103048|NCT00555321|P4|Participant Flow|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103049|NCT00555321|P3|Participant Flow|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103050|NCT00555321|P2|Participant Flow|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103051|NCT00555321|P1|Participant Flow|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103052|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103053|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103054|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103055|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103057|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1104082|NCT00553319|E2|Reported Event|Adderall-XR 60 mg|"Adderall-XR 60 mg~Adderall-XR: Adderall-XR 60mg/day"
1103058|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103059|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103060|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103061|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103062|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103063|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103064|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103065|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103066|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103067|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103068|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103069|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103070|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103071|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103072|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103073|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103074|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103075|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103076|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103077|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103078|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103079|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103080|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103081|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103082|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103083|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103084|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103085|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103086|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103087|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
1103088|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103089|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103090|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103091|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
1103092|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103093|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103094|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103095|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103096|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103097|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
1103098|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103099|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103100|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103374|NCT00555152|O2|Outcome|Arm II Lapatinib 1000 mg|Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
1103101|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
1103102|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103103|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103104|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103105|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103106|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103107|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103108|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103109|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103110|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103111|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103112|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103113|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103114|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103115|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103116|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103117|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103118|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103119|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103120|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103121|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103554|NCT00554515|O2|Outcome|PD-L1 Tumor Positive|
1103555|NCT00554515|O1|Outcome|PD-L1 Tumor Negative|
1103123|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103124|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103125|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103126|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103127|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
1103128|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103129|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103210|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103130|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103131|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
1103132|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
1103133|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103134|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103135|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103136|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
1103137|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
1103138|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103139|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103140|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103141|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
1103142|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
1103143|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103144|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103145|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103146|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
1103147|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
1103148|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103149|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103391|NCT00555152|E1|Reported Event|Arm I Lapatinib 1500 mg|Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
1103150|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103151|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
1103152|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
1103153|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103154|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103155|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103156|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
1103157|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
1103158|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103159|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103160|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103161|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
1103162|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
1103163|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103369|NCT00555152|P3|Participant Flow|Arm III Lapatinib 750 mg|Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
1103164|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103165|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103166|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
1103167|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
1103168|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103169|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103170|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103171|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
1103172|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
1103173|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103174|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103175|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103176|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
1103177|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
1103178|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103179|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103180|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103181|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
1103182|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
1103183|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103370|NCT00555152|P2|Participant Flow|Arm II Lapatinib 1000 mg|Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
1103184|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103185|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103186|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
1103187|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
1103188|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103189|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103190|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103191|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
1103192|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
1103193|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103194|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103195|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103196|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
1103197|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
1103198|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103199|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103200|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103201|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
1103202|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
1103203|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103371|NCT00555152|P1|Participant Flow|Arm I Lapatinib 1500 mg|Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
1103204|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103205|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
1103206|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
1103207|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103208|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103209|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103430|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
1103211|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103212|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103213|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103214|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103215|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103216|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103217|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103218|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103219|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103220|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103221|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103222|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103223|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103224|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103372|NCT00555152|O4|Outcome|Arm IV Placebo|Placebo orally once daily for 2-6 weeks until the time of surgery.
1104122|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
1103225|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103226|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103227|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103228|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103229|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103230|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103274|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103663|NCT00554099|O1|Outcome|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
1103231|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103232|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103233|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103234|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103235|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103236|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103237|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103238|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103239|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103240|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103241|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103242|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103243|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103244|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103245|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103268|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103246|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103247|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103248|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103249|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103250|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103275|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103251|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103252|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103253|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103254|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103255|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103256|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103257|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103258|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103259|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103260|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103261|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103262|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103263|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103264|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103265|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103266|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103267|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103269|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103270|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103271|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103272|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103273|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103276|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103277|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103278|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103279|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103280|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103281|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103282|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103283|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103284|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103285|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103286|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103287|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103288|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103289|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103333|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103290|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103291|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103292|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103293|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103294|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103295|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103339|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103296|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103297|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103298|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103299|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103300|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103301|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103302|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103303|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103304|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103305|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103306|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103307|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103308|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103309|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103310|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103367|NCT00555152|B1|Baseline|Arm I Lapatinib 1500 mg|Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
1103368|NCT00555152|P4|Participant Flow|Arm IV Placebo|Placebo orally once daily for 2-6 weeks until the time of surgery.
1103311|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103312|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103313|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103314|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103315|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103340|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103316|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103317|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103318|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103319|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103320|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103321|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103322|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103323|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103324|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103325|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103326|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103327|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103328|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103329|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103330|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103331|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103332|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103334|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103335|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103336|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103337|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103338|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103341|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103342|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
1103343|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103344|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
1103345|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103346|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
1103347|NCT00555321|E5|Reported Event|Tacrolimus + MMF|
1103348|NCT00555321|E4|Reported Event|Tacrolimus|
1103349|NCT00555321|E3|Reported Event|Belaticept (LI) + MMF|
1103350|NCT00555321|E2|Reported Event|MI+MMF|
1103351|NCT00555321|E1|Reported Event|Basiliximab+Belatacept (MI)+Mycophenolate Mofetil (MMF)|
1103352|NCT00555217|B3|Baseline|Total|Total of all reporting groups
1103353|NCT00555217|B2|Baseline|Monotherapy ARB|"Mono therapy arm. Standard treatment with angiotensin receptor blocker (ARB)~losartan: 50 or 100mg/day"
1103354|NCT00555217|B1|Baseline|Combination of ARB and ACEI|"Combination of an angiotensin converting enzyme inhibitor (ACEI) with an angiotensin receptor blocker (ARB)~losartan: 50 or 100mg/day~lisinopril: 10, 20 or 40 mg/day"
1103355|NCT00555217|P2|Participant Flow|Monotherapy ARB|"Mono therapy arm. Standard treatment with angiotensin receptor blocker (ARB)~losartan: 50 or 100mg/day"
1103356|NCT00555217|P1|Participant Flow|Combination of ARB and ACEI|"Combination of an angiotensin converting enzyme inhibitor (ACEI) with an angiotensin receptor blocker (ARB)~losartan: 50 or 100mg/day~lisinopril: 10, 20 or 40 mg/day"
1103357|NCT00555217|O2|Outcome|Monotherapy ARB|Mono therapy arm. Standard treatment with angiotensin receptor blocker (ARB)
1103358|NCT00555217|O1|Outcome|Combination of ARB and ACEI|Combination of an angiotensin converting enzyme inhibitor (ACEI) with an angiotensin receptor blocker (ARB)
1103359|NCT00555217|O2|Outcome|Monotherapy ARB|Mono therapy arm. Standard treatment with angiotensin receptor blocker (ARB)
1103360|NCT00555217|O1|Outcome|Combination of ARB and ACEI|Combination of an angiotensin converting enzyme inhibitor (ACEI) with an angiotensin receptor blocker (ARB)
1103361|NCT00555217|E2|Reported Event|Monotherapy ARB|Mono therapy arm. Standard treatment with angiotensin receptor blocker (ARB)
1103362|NCT00555217|E1|Reported Event|Combination of ARB and ACEI|Combination of an angiotensin converting enzyme inhibitor (ACEI) with an angiotensin receptor blocker (ARB)
1103363|NCT00555152|B5|Baseline|Total|Total of all reporting groups
1103364|NCT00555152|B4|Baseline|Arm IV Placebo|Placebo orally once daily for 2-6 weeks until the time of surgery.
1103365|NCT00555152|B3|Baseline|Arm III Lapatinib 750 mg|Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
1103366|NCT00555152|B2|Baseline|Arm II Lapatinib 1000 mg|Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
1104123|NCT00553267|O1|Outcome|Amlodipine 10mg|
1103375|NCT00555152|O1|Outcome|Arm I Lapatinib 1500 mg|Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
1103376|NCT00555152|O4|Outcome|Arm IV Placebo|Placebo orally once daily for 2-6 weeks until the time of surgery.
1103377|NCT00555152|O3|Outcome|Arm III Lapatinib 750 mg|Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
1103378|NCT00555152|O2|Outcome|Arm II Lapatinib 1000 mg|Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
1103379|NCT00555152|O1|Outcome|Arm I Lapatinib 1500 mg|Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
1103380|NCT00555152|O4|Outcome|Arm IV Placebo|Placebo orally once daily for 2-6 weeks until the time of surgery.
1103381|NCT00555152|O3|Outcome|Arm III Lapatinib 750 mg|Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
1103382|NCT00555152|O2|Outcome|Arm II Lapatinib 1000 mg|Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
1103383|NCT00555152|O1|Outcome|Arm I Lapatinib 1500 mg|Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
1103384|NCT00555152|O4|Outcome|Arm IV Placebo|Placebo orally once daily for 2-6 weeks until the time of surgery.
1103385|NCT00555152|O3|Outcome|Arm III Lapatinib 750 mg|Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
1103386|NCT00555152|O2|Outcome|Arm II Lapatinib 1000 mg|Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
1103387|NCT00555152|O1|Outcome|Arm I Lapatinib 1500 mg|Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
1103388|NCT00555152|E4|Reported Event|Arm IV Placebo|Placebo orally once daily for 2-6 weeks until the time of surgery.
1103389|NCT00555152|E3|Reported Event|Arm III Lapatinib 750 mg|Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
1103390|NCT00555152|E2|Reported Event|Arm II Lapatinib 1000 mg|Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
1106930|NCT00546871|O6|Outcome|Total SC (Study Parts 2, 3a, 3b, Extension)|
1103392|NCT00555061|B1|Baseline|Retapamulin Ointment, 1%|Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
1103393|NCT00555061|P1|Participant Flow|Retapamulin Ointment, 1%|Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
1103394|NCT00555061|O1|Outcome|Retapamulin Ointment, 1%|Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
1103395|NCT00555061|O1|Outcome|Retapamulin Ointment, 1%|Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
1103396|NCT00555061|O1|Outcome|Retapamulin Ointment, 1%|Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
1103397|NCT00555061|O1|Outcome|Retapamulin Ointment, 1%|Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
1103398|NCT00555061|E1|Reported Event|Retapamulin Ointment, 1%|Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
1103399|NCT00555048|B1|Baseline|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.~alemtuzumab~busulfan~cyclophosphamide~methotrexate~tacrolimus~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
1103400|NCT00555048|P1|Participant Flow|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.~alemtuzumab~busulfan~cyclophosphamide~methotrexate~tacrolimus~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
1103401|NCT00555048|O1|Outcome|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.~alemtuzumab~busulfan~cyclophosphamide~methotrexate~tacrolimus~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
1103402|NCT00555048|O1|Outcome|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.~alemtuzumab~busulfan~cyclophosphamide~methotrexate~tacrolimus~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
1103403|NCT00555048|O1|Outcome|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.~alemtuzumab~busulfan~cyclophosphamide~methotrexate~tacrolimus~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
1103404|NCT00555048|O1|Outcome|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.~alemtuzumab~busulfan~cyclophosphamide~methotrexate~tacrolimus~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
1103405|NCT00555048|O1|Outcome|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.~alemtuzumab~busulfan~cyclophosphamide~methotrexate~tacrolimus~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
1103406|NCT00555048|O1|Outcome|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.~alemtuzumab~busulfan~cyclophosphamide~methotrexate~tacrolimus~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
1103407|NCT00555048|O1|Outcome|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.~alemtuzumab~busulfan~cyclophosphamide~methotrexate~tacrolimus~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
1103408|NCT00555048|E1|Reported Event|Alemtuzumab|"Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.~alemtuzumab~busulfan~cyclophosphamide~methotrexate~tacrolimus~allogeneic hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
1103409|NCT00555009|B3|Baseline|Total|Total of all reporting groups
1103410|NCT00555009|B2|Baseline|Placebo|Matching placebo injected SC.
1103411|NCT00555009|B1|Baseline|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
1103412|NCT00555009|P2|Participant Flow|Placebo|Matching placebo injected SC.
1103413|NCT00555009|P1|Participant Flow|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
1103414|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
1103415|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
1103416|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
1103417|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
1103418|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
1103419|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
1103420|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
1103421|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
1103422|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
1103423|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
1103424|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
1103425|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
1103426|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
1103427|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
1103428|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
1103429|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
1103431|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
1103432|NCT00555009|E2|Reported Event|Placebo|Matching placebo injected SC.
1103433|NCT00555009|E1|Reported Event|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
1103434|NCT00554996|B1|Baseline|E. Coli 83972 Coated Urinary Catheter|E. coli 83972 coated urinary catheter: E. coli 83972 coated urinary catheter
1103435|NCT00554996|P1|Participant Flow|E. Coli 83972 Coated Urinary Catheter|E. coli 83972 coated urinary catheter: E. coli 83972 coated urinary catheter
1103436|NCT00554996|O1|Outcome|E. Coli 83972 Coated Urinary Catheter|E. coli 83972 coated urinary catheter: E. coli 83972 coated urinary catheter
1103437|NCT00554996|E1|Reported Event|E. Coli 83972 Coated Urinary Catheter|E. coli 83972 coated urinary catheter: E. coli 83972 coated urinary catheter
1103438|NCT00554970|B5|Baseline|Total|Total of all reporting groups
1103439|NCT00554970|B4|Baseline|Treatment 4 Then Treatment 3|Subjects received Treatment 4 in period 1 followed by a 7 day washout period and then Treatment 3 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
1103440|NCT00554970|B3|Baseline|Treatment 3 Then Treatment 4|Subjects received Treatment 3 in period 1 followed by a 7 day washout period and then Treatment 4 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
1103441|NCT00554970|B2|Baseline|Treatment 2, Then Treatment 1|Subjects received Treatment 2 in period 1 followed by a 7 day washout period and then Treatment 1 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
1103442|NCT00554970|B1|Baseline|Treatment 1 Then Treatment 2|Subjects received Treatment 1 in period 1 followed by a 7 day washout period and then Treatment 2 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
1103443|NCT00554970|P4|Participant Flow|Treatment 4 Then Treatment 3|Subjects received Treatment 4 in period 1 followed by a 7 day washout period and then Treatment 3 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
1103444|NCT00554970|P3|Participant Flow|Treatment 3 Then Treatment 4|Subjects received Treatment 3 in period 1 followed by a 7 day washout period and then Treatment 4 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
1103445|NCT00554970|P2|Participant Flow|Treatment 2 Then Treatment 1|Subjects received Treatment 2 in period 1 followed by a 7 day washout period and then Treatment 1 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
1103446|NCT00554970|P1|Participant Flow|Treatment 1 Then Treatment 2|Subjects received Treatment 1 in period 1 followed by a 7 day washout period and then Treatment 2 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
1103447|NCT00554970|O4|Outcome|Pulmicort Respules® 0.25 mg|a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol
1103448|NCT00554970|O3|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
1103449|NCT00554970|O2|Outcome|Pulmicort Respules® 0.50 mg|a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
1103450|NCT00554970|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
1103451|NCT00554970|O4|Outcome|Pulmicort Respules® 0.25 mg|a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol
1103452|NCT00554970|O3|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
1103453|NCT00554970|O2|Outcome|Pulmicort Respules® 0.50 mg|a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
1103454|NCT00554970|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
1103455|NCT00554970|O4|Outcome|Pulmicort Respules® 0.25 mg|a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol
1103456|NCT00554970|O3|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
1103457|NCT00554970|O2|Outcome|Pulmicort Respules® 0.50 mg|a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
1103458|NCT00554970|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
1103459|NCT00554970|O4|Outcome|Pulmicort Respules® 0.25 mg|a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol
1103460|NCT00554970|O3|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
1103461|NCT00554970|O2|Outcome|Pulmicort Respules® 0.50 mg|a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
1103462|NCT00554970|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
1103463|NCT00554970|O4|Outcome|Pulmicort Respules® 0.25 mg|a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol
1103464|NCT00554970|O3|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
1103465|NCT00554970|O2|Outcome|Pulmicort Respules® 0.50 mg|a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
1103466|NCT00554970|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
1103467|NCT00554970|O4|Outcome|Pulmicort Respules® 0.25 mg|a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol
1103468|NCT00554970|O3|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
1103469|NCT00554970|O2|Outcome|Pulmicort Respules® 0.50 mg|a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
1103470|NCT00554970|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
1103471|NCT00554970|E4|Reported Event|Treatment 4 Then Treatment 3|Subjects received Treatment 4 in period 1 followed by a 7 day washout period and then Treatment 3 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
1103472|NCT00554970|E3|Reported Event|Treatment 3 Then Treatment 4|Subjects received Treatment 3 in period 1 followed by a 7 day washout period and then Treatment 4 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
1103473|NCT00554970|E2|Reported Event|Treatment 2, Then Treatment 1|Subjects received Treatment 2 in period 1 followed by a 7 day washout period and then Treatment 1 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
1103474|NCT00554970|E1|Reported Event|Treatment 1 Then Treatment 2|Subjects received Treatment 1 in period 1 followed by a 7 day washout period and then Treatment 2 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
1103475|NCT00554853|B3|Baseline|Total|Total of all reporting groups
1103476|NCT00554853|B2|Baseline|Placebo Then Study Drug (Pioglitazone)|Oral daily placebo for 3 months compared to pioglitazone for 3 months, crossover after a 2 month washout.
1103477|NCT00554853|B1|Baseline|Study Drug (Pioglitazone) Then Placebo|Oral daily pioglitazone for 3 months compared to placebo for 3 months,crossover after a 2 month washout.
1103478|NCT00554853|P2|Participant Flow|Placebo Then Study Drug (Pioglitazone)|Oral daily placebo for 3 months, followed by 2 month wash out period, then crossover to study drug (pioglitazone) for 3 months.
1103479|NCT00554853|P1|Participant Flow|Study Drug (Pioglitazone) Then Placebo|Oral daily pioglitazone (study drug for 3 months, followed by 2 month wash out period, then crossover to placebo for 3 months.
1103480|NCT00554853|O2|Outcome|All Participants While on Study Drug (Pioglitazone)|Oral daily placebo for 3 months compared to study drug (pioglitazone) for 3 months, crossover after a 2 month washout.
1103481|NCT00554853|O1|Outcome|All Participants While on Placebo|Oral daily study drug (pioglitazone) for 3 months compared to placebo for 3 months, crossover after a 2 month washout.
1103482|NCT00554853|O2|Outcome|Placebo Then Study Drug (Pioglitazone)|Oral daily placebo for 3 months compared to study drug (pioglitazone) for 3 months, crossover after a 2 month washout.
1103483|NCT00554853|O1|Outcome|Study Drug (Pioglitazone) Then Placebo|Oral daily study drug (pioglitazone) for 3 months compared to placebo for 3 months, crossover after a 2 month washout.
1104124|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
1103484|NCT00554853|E6|Reported Event|Placebo Then Study Drug (Piolglitazone) While on Study Drug|Oral daily placebo for 3 months, followed by 2 month wash out period, then crossover to study drug (pioglitazone) 45 mg daily for 3 months.
1103485|NCT00554853|E5|Reported Event|Placebo Then Study Drug (Pioglitazone) During Washout|Oral daily placebo for 3 months, followed by 2 month wash out period, then crossover to study drug (pioglitazone) 45 mg daily for 3 months.
1103486|NCT00554853|E4|Reported Event|Placebo Then Study Drug (Pioglitazone) While on Placebo|Oral daily placebo for 3 months, followed by 2 month wash out period, then crossover to study drug (pioglitazone) 45 mg daily for 3 months.
1103487|NCT00554853|E3|Reported Event|Study Drug (Pioglitazone) Then Placebo, While on Placebo|Oral daily pioglitazone 45 mg daily(study drug for 3 months, followed by 2 month wash out period, then crossover to placebo for 3 months.
1103488|NCT00554853|E2|Reported Event|Study Drug (Pioglitazone) Then Placebo, During Washout|Oral daily pioglitazone 45 mg daily(study drug for 3 months, followed by 2 month wash out period, then crossover to placebo for 3 months.
1103489|NCT00554853|E1|Reported Event|Study Drug (Pioglitazone) Then Placebo, While on Drug|Oral daily pioglitazone 45 mg daily(study drug for 3 months, followed by 2 month wash out period, then crossover to placebo for 3 months.
1103490|NCT00554840|B3|Baseline|Total|Total of all reporting groups
1103491|NCT00554840|B2|Baseline|Placebo|placebo: At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
1103492|NCT00554840|B1|Baseline|Varenicline|varenicline: Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
1103719|NCT00553787|E2|Reported Event|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
1103493|NCT00554840|P2|Participant Flow|Placebo|placebo: At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
1103494|NCT00554840|P1|Participant Flow|Varenicline|varenicline: Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
1103495|NCT00554840|O2|Outcome|Placebo|Subjects randomized to matching placebo capsules will use the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
1103496|NCT00554840|O1|Outcome|Varenicline|Subjects randomized to active treatment (varenicline) will use the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
1103497|NCT00554840|O2|Outcome|Placebo|placebo: At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
1103498|NCT00554840|O1|Outcome|Varenicline|varenicline: Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
1103499|NCT00554840|O2|Outcome|Placebo|placebo: At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
1103500|NCT00554840|O1|Outcome|Varenicline|varenicline: Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
1103501|NCT00554840|O2|Outcome|Placebo|placebo: At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
1103502|NCT00554840|O1|Outcome|Varenicline|varenicline: Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
1103503|NCT00554840|O2|Outcome|Placebo|Subjects randomized to matching placebo capsules will use the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
1103504|NCT00554840|O1|Outcome|Varenicline|Subjects randomized to active treatment (varenicline) will use the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
1103793|NCT00553631|O1|Outcome|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
1103505|NCT00554840|O2|Outcome|Placebo|Subjects randomized to matching placebo capsules will use the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
1103506|NCT00554840|O1|Outcome|Varenicline|Subjects randomized to active treatment (varenicline) will use the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
1103507|NCT00554840|E2|Reported Event|Placebo|Subjects randomized to matching placebo will have the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
1103508|NCT00554840|E1|Reported Event|Varenicline|Subjects randomized to receive active drug (varenicline) will have the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase.
1103509|NCT00554801|B3|Baseline|Total|Total of all reporting groups
1103510|NCT00554801|B2|Baseline|Control Group|No exposure to high-intensity blast; matched to blast-exposed group on gender, age, and hearinig loss
1103511|NCT00554801|B1|Baseline|Blast-exposed|"The study group includes soldiers who have recently been exposed to a high-explosive blast while stationed in Iraq or Afghanistan. They will be recruited at Walter Reed Army Medical Center, Washington, DC.~Audiological testing: Subjects will take part in a battery of audiological tests meant to evaluate the function and status of the auditory system. These tests are similar to the kinds of testing carried out routinely in audiology clinics, and include behavioral tests of pure tone hearing, speech perception, and central auditory function, and electrophysiological testing of the middle ear and of the central auditory system."
1103512|NCT00554801|P2|Participant Flow|Control Group|No exposure to high-intensity blast; matched to blast-exposed group on gender, age, and hearinig loss
1103566|NCT00554515|O3|Outcome|Poor MSKCC Risk Group|MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
1103513|NCT00554801|P1|Participant Flow|Blast-exposed|"The study group includes soldiers who have recently been exposed to a high-explosive blast while stationed in Iraq or Afghanistan. They will be recruited at Walter Reed Army Medical Center, Washington, DC.~Audiological testing: Subjects will take part in a battery of audiological tests meant to evaluate the function and status of the auditory system. These tests are similar to the kinds of testing carried out routinely in audiology clinics, and include behavioral tests of pure tone hearing, speech perception, and central auditory function, and electrophysiological testing of the middle ear and of the central auditory system."
1103514|NCT00554801|O2|Outcome|Control Group|No exposure to high-intensity blast; matched to blast-exposed group on gender, age, and hearinig loss
1103515|NCT00554801|O1|Outcome|Blast-exposed|"The study group includes soldiers who have recently been exposed to a high-explosive blast while stationed in Iraq or Afghanistan. They will be recruited at Walter Reed Army Medical Center, Washington, DC.~Audiological testing: Subjects will take part in a battery of audiological tests meant to evaluate the function and status of the auditory system. These tests are similar to the kinds of testing carried out routinely in audiology clinics, and include behavioral tests of pure tone hearing, speech perception, and central auditory function, and electrophysiological testing of the middle ear and of the central auditory system."
1103516|NCT00554801|E2|Reported Event|Control Group|No exposure to high-intensity blast; matched to blast-exposed group on gender, age, and hearinig loss
1103517|NCT00554801|E1|Reported Event|Blast-exposed|"The study group includes soldiers who have recently been exposed to a high-explosive blast while stationed in Iraq or Afghanistan. They will be recruited at Walter Reed Army Medical Center, Washington, DC.~Audiological testing: Subjects will take part in a battery of audiological tests meant to evaluate the function and status of the auditory system. These tests are similar to the kinds of testing carried out routinely in audiology clinics, and include behavioral tests of pure tone hearing, speech perception, and central auditory function, and electrophysiological testing of the middle ear and of the central auditory system."
1103518|NCT00554749|B1|Baseline|Behavioral|All participants received identical behavioral treatment with no control group.
1103519|NCT00554749|P1|Participant Flow|Behavioral|All participants received identical behavioral treatment with no control group.
1103520|NCT00554749|O1|Outcome|Behavioral|All participants received identical behavioral treatment with no control group.
1103521|NCT00554749|O1|Outcome|Behavioral|All participants received identical behavioral treatment with no control group.
1103522|NCT00554749|E1|Reported Event|Behavioral|All participants received identical behavioral treatment with no control group.
1103523|NCT00554671|B3|Baseline|Total|Total of all reporting groups
1103524|NCT00554671|B2|Baseline|Usual Care|Patients continued on usual care without pharmacist-led group medical visits
1103525|NCT00554671|B1|Baseline|Pharmacist-led Group Medical Visits|"Pharmacist-led group medical visits which consists of medication titration and behavioral modification~Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes~Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals~Group support: Peer support are provided in the group setting~Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision"
1103526|NCT00554671|P2|Participant Flow|Usual Care|Patients continued on usual care without pharmacist-led group medical visits
1103527|NCT00554671|P1|Participant Flow|Pharmacist-led Group Medical Visits|"Pharmacist-led group medical visits which consists of medication titration and behavioral modification~Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes~Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals~Group support: Peer support are provided in the group setting~Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision"
1103528|NCT00554671|O2|Outcome|Usual Care|Patients continued on usual care without pharmacist-led group medical visits
1103556|NCT00554515|O2|Outcome|Low CA-9 Score|This score is based on the expression of the CA 9 protein (encoded by the CA9 gene) assessed from patient’s tumor specimen. CA 9 expression score is quantified by immunohistochemical analysis using CA9 monoclonal antibody (M75); Low is </=85% of CAIX positive tumor cells
1103794|NCT00553631|O2|Outcome|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
1104083|NCT00553319|E1|Reported Event|Placebo|"Placebo~Placebo: Placebo group"
1103529|NCT00554671|O1|Outcome|Pharmacist-led Group Medical Visits|"Pharmacist-led group medical visits which consists of medication titration and behavioral modification~Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes~Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals~Group support: Peer support are provided in the group setting~Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision"
1103530|NCT00554671|O2|Outcome|Usual Care|Patients continued on usual care without pharmacist-led group medical visits
1103531|NCT00554671|O1|Outcome|Pharmacist-led Group Medical Visits|"Pharmacist-led group medical visits which consists of medication titration and behavioral modification~Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes~Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals~Group support: Peer support are provided in the group setting~Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision"
1103532|NCT00554671|E2|Reported Event|Usual Care|Patients continued on usual care without pharmacist-led group medical visits
1103567|NCT00554515|O2|Outcome|Intermediate MSKCC Risk Group|MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
1103661|NCT00554099|O3|Outcome|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
1103662|NCT00554099|O2|Outcome|Mesalamine|400 mg mesalamine (6 tablets daily)
1103533|NCT00554671|E1|Reported Event|Pharmacist-led Group Medical Visits|"Pharmacist-led group medical visits which consists of medication titration and behavioral modification~Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes~Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals~Group support: Peer support are provided in the group setting~Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision"
1103534|NCT00554619|B1|Baseline|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
1103535|NCT00554619|P1|Participant Flow|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
1103536|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
1103537|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
1103538|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
1103539|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
1103540|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
1103541|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
1103542|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
1103543|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
1103544|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
1103545|NCT00554619|E1|Reported Event|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
1103546|NCT00554515|B1|Baseline|HD IL2|Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
1103547|NCT00554515|P1|Participant Flow|HD IL2|Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
1103548|NCT00554515|O1|Outcome|HD IL2|Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
1103549|NCT00554515|O1|Outcome|HD IL2|Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
1103550|NCT00554515|O2|Outcome|CA-9 SNP Variant|Patient’s SNP (Single Nucleotide Polymorphism) status is determined by sequencing their tumor specimens. Patients are classified as homozygous or variant based on the observed nucleotide sequence.
1103551|NCT00554515|O1|Outcome|CA-9 SNP Homozygous|Patient’s SNP (Single Nucleotide Polymorphism) status is determined by sequencing their tumor specimens. Patients are classified as homozygous or variant based on the observed nucleotide sequence.
1103552|NCT00554515|O2|Outcome|Positive|
1103553|NCT00554515|O1|Outcome|Negative|
1103557|NCT00554515|O1|Outcome|High CA-9 Score|This score is based on the expression of the CA 9 protein (encoded by the CA9 gene) assessed from patient’s tumor specimen. CA 9 expression score is quantified by immunohistochemical analysis using CA9 monoclonal antibody (M75); High is >85% of CAIX positive tumor cells.
1103558|NCT00554515|O3|Outcome|Poor Clear Cell Histology Risk Group|
1103559|NCT00554515|O2|Outcome|Intermediate Clear Cell Histology Risk Group|
1103560|NCT00554515|O1|Outcome|Good Clear Cell Histology Risk Group|
1103561|NCT00554515|O2|Outcome|Non-clear Cell Tumor Type|
1103562|NCT00554515|O1|Outcome|Clear Cell Tumor Type|
1103563|NCT00554515|O3|Outcome|High UCLA SANI Score|This tool predicts RCC patient’s survival based on lymph node status, metastases, sarcomatoid feature, and TSH level. Patients are classified into 3 groups (low, intermediate, and high).
1103564|NCT00554515|O2|Outcome|Intermediate UCLA SANI Score|This tool predicts RCC patient’s survival based on lymph node status, metastases, sarcomatoid feature, and TSH level. Patients are classified into 3 groups (low, intermediate, and high).
1103565|NCT00554515|O1|Outcome|Low UCLA SANI Score|This tool predicts RCC patient’s survival based on lymph node status, metastases, sarcomatoid feature, and TSH level. Patients are classified into 3 groups (low, intermediate, and high).
1103568|NCT00554515|O1|Outcome|Favorable MSKCC Risk Group|MSKCC developed a nomogram that is used to classify patients into 3 renal cell carcinoma (RCC) 5-year disease recurrence risk groups (low, intermediate, and high) using data from patients treated at MSK. The components of the nomogram include RCC histology, disease symptoms, pT stage, and tumor size.
1103569|NCT00554515|O1|Outcome|HD IL2|Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
1103570|NCT00554515|O1|Outcome|HD IL2|Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
1103571|NCT00554515|O1|Outcome|HD IL2|Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
1103572|NCT00554515|O1|Outcome|ISM Poor Risk Group|"ISM [Atkins et al CCR 2005]:~Poor predictive pathology OR the combination of intermediate predictive pathology and low CAIX staining~Pathology [Upton et al. J Immunother 2005] Poor predictive pathology: non-clear-cell histology OR some (>0%) papillary features OR no alveolar features OR >50% granular features Intermediate predictive pathology: clear-cell histology AND no papillary features AND some (>0%) alveolar features AND 50% granular features~CAIX [Bui et al. CCR 2003] Low CAIX staining: </=85% of CAIX positive tumor cells"
1103573|NCT00554515|O1|Outcome|ISM Good Risk Group|"ISM [Atkins et al CCR 2005]:~Good predictive pathology OR the combination of intermediate predictive pathology and high CAIX staining~Pathology [Upton et al. J Immunother 2005] Good predictive pathology: clear-cell histology AND no papillary features AND >50% alveolar features AND no granular features Intermediate predictive pathology: clear-cell histology AND no papillary features AND some (>0%) alveolar features AND 50% granular features~CAIX [Bui et al. CCR 2003] High CAIX staining: >85% of CAIX positive tumor cells"
1103574|NCT00554515|E1|Reported Event|HD IL2|Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
1103575|NCT00554463|B1|Baseline|Combined Modality Therapy With Growth Factor Support|Radiation therapy, concurrent chemotherapy and Filgrastim followed by adjuvant chemotherapy and Pegfilgrastim
1103576|NCT00554463|P1|Participant Flow|Combined Modality Therapy With Growth Factor Support|Radiation therapy, concurrent chemotherapy and Filgrastim followed by adjuvant chemotherapy and Pegfilgrastim
1103577|NCT00554463|O1|Outcome|Combined Modality Therapy With Growth Factor Support|Radiation therapy, concurrent chemotherapy and Filgrastim followed by adjuvant chemotherapy and Pegfilgrastim
1103578|NCT00554463|E1|Reported Event|Combined Modality Therapy With Growth Factor Support|Radiation therapy, concurrent chemotherapy and Filgrastim followed by adjuvant chemotherapy and Pegfilgrastim
1103579|NCT00554372|B3|Baseline|Total|Total of all reporting groups
1103580|NCT00554372|B2|Baseline|High Dose|1e9 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
1103627|NCT00554216|B3|Baseline|VI-0521 Top|PHEN/TPM 15/92
1103581|NCT00554372|B1|Baseline|Low Dose|1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
1103582|NCT00554372|P2|Participant Flow|High Dose|1e9 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
1103583|NCT00554372|P1|Participant Flow|Low Dose|1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
1103584|NCT00554372|O2|Outcome|High Dose|1e9 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
1103585|NCT00554372|O1|Outcome|Low Dose|1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
1103586|NCT00554372|O2|Outcome|High Dose|1e9 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
1103587|NCT00554372|O1|Outcome|Low Dose|1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
1103588|NCT00554372|O2|Outcome|High Dose|"1e9 pfu (plaque-forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart)~JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF): Patients will be randomized 1:1 to one of two total doses (1e8 or 1e9 pfu)and injected intratumorally in 1-5 intrahepatic tumors on Days 1, 15, and 29."
1103589|NCT00554372|O1|Outcome|Low Dose|"1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart)~JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF): Patients will be randomized 1:1 to one of two total doses (1e8 or 1e9 pfu)and injected intratumorally in 1-5 intrahepatic tumors on Days 1, 15, and 29."
1103590|NCT00554372|O2|Outcome|High Dose|1e9 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
1103591|NCT00554372|O1|Outcome|Low Dose|1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
1103592|NCT00554372|E2|Reported Event|High Dose|1e9 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
1103593|NCT00554372|E1|Reported Event|Low Dose|1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
1103594|NCT00554294|B3|Baseline|Total|Total of all reporting groups
1103595|NCT00554294|B2|Baseline|Intervention Group|Schools received water fountains, drinking bottles and lessons as intervention.
1103596|NCT00554294|B1|Baseline|Control Group|Schools did not receive any intervention.
1103597|NCT00554294|P2|Participant Flow|Intervention Group|Schools received water fountains, drinking bottles and lessons as intervention.
1103598|NCT00554294|P1|Participant Flow|Control Group|Schools did not receive any intervention.
1103599|NCT00554294|O2|Outcome|Intervention Group|Schools received water fountains, drinking bottles and lessons as intervention.
1103600|NCT00554294|O1|Outcome|Control Group|Schools did not receive any intervention.
1103601|NCT00554229|B3|Baseline|Total|Total of all reporting groups
1103602|NCT00554229|B2|Baseline|Placebo|Placebo oral tablet once daily
1103603|NCT00554229|B1|Baseline|ZD4054|ZD4054 10 mg oral tablet once daily
1103604|NCT00554229|P2|Participant Flow|Placebo|Placebo oral tablet once daily
1103605|NCT00554229|P1|Participant Flow|ZD4054|ZD4054 10 mg oral tablet once daily
1103606|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
1103607|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
1103608|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
1103609|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
1103610|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
1103611|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
1103612|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
1103613|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
1103614|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
1103615|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
1103616|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
1103617|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
1103618|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
1103619|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
1103620|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
1103621|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
1103622|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
1103623|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
1103624|NCT00554229|E2|Reported Event|Placebo|Placebo oral tablet once daily
1103625|NCT00554229|E1|Reported Event|ZD4054|ZD4054 10 mg oral tablet once daily
1103626|NCT00554216|B4|Baseline|Total|Total of all reporting groups
1103643|NCT00554190|P1|Participant Flow|AdvaCoat and Merogel|AdvaCoat compared to Merogel Injectable. Subjects were randomized to receive AdvaCoat applied to the right or left middle meatus tissues and Merogel applied to the middle meatus tissues on the opposite side.
1103644|NCT00554190|O2|Outcome|AdvaCoat Sinus Gel|AdvaCoat compared to MeroGel Injectable
1103645|NCT00554190|O1|Outcome|Merogel Injectable|Merogel Injectable compared to AdvaCoat
1103646|NCT00554190|O2|Outcome|AdvaCoat Sinus Gel|AdvaCoat compared to MeroGel Injectable
1103647|NCT00554190|O1|Outcome|Merogel Injectable|Merogel Injectable compared to AdvaCoat
1103648|NCT00554099|B4|Baseline|Total|Total of all reporting groups
1103649|NCT00554099|B3|Baseline|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
1103650|NCT00554099|B2|Baseline|Mesalamine|400 mg mesalamine (6 tablets daily)
1103651|NCT00554099|B1|Baseline|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
1103652|NCT00554099|P3|Participant Flow|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
1103653|NCT00554099|P2|Participant Flow|Mesalamine|400 mg mesalamine (6 tablets daily)
1103654|NCT00554099|P1|Participant Flow|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
1103655|NCT00554099|O3|Outcome|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
1103656|NCT00554099|O2|Outcome|Mesalamine|400 mg mesalamine (6 tablets daily)
1103657|NCT00554099|O1|Outcome|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
1103658|NCT00554099|O3|Outcome|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
1103659|NCT00554099|O2|Outcome|Mesalamine|400 mg mesalamine (6 tablets daily)
1103660|NCT00554099|O1|Outcome|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
1103664|NCT00554099|O3|Outcome|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
1103665|NCT00554099|O2|Outcome|Mesalamine|400 mg mesalamine (6 tablets daily)
1103666|NCT00554099|O1|Outcome|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
1103667|NCT00554099|O3|Outcome|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
1103668|NCT00554099|O2|Outcome|Mesalamine|400 mg mesalamine (6 tablets daily)
1103669|NCT00554099|O1|Outcome|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
1103670|NCT00554099|O3|Outcome|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
1103671|NCT00554099|O2|Outcome|Mesalamine|400 mg mesalamine (6 tablets daily)
1103672|NCT00554099|O1|Outcome|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
1103673|NCT00554099|O3|Outcome|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
1103674|NCT00554099|O2|Outcome|Mesalamine|400 mg mesalamine (6 tablets daily)
1103675|NCT00554099|O1|Outcome|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
1103676|NCT00554099|O3|Outcome|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
1103677|NCT00554099|O2|Outcome|Mesalamine|400 mg mesalamine (6 tablets daily)
1103678|NCT00554099|O1|Outcome|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
1103679|NCT00554099|E3|Reported Event|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
1103680|NCT00554099|E2|Reported Event|Mesalamine|400 mg mesalamine (6 tablets daily)
1103681|NCT00554099|E1|Reported Event|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
1103682|NCT00553969|B5|Baseline|Total|Total of all reporting groups
1103683|NCT00553969|B4|Baseline|4 Placebo + Placebo|
1103684|NCT00553969|B3|Baseline|3 Lisinopril + Placebo|"lisinopril + placebo~lisinopril : tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
1103685|NCT00553969|B2|Baseline|2 Coreg CR + Placebo|"Coreg CR + placebo~carvedilol phosphate : Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months"
1103686|NCT00553969|B1|Baseline|1 Coreg CR + Lisinopril|"Coreg CR + lisinopril~carvedilol phosphate and lisinopril : carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
1103687|NCT00553969|P4|Participant Flow|4 Placebo + Placebo|
1103688|NCT00553969|P3|Participant Flow|3 Lisinopril + Placebo|"lisinopril + placebo~lisinopril : tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
1103689|NCT00553969|P2|Participant Flow|2 Coreg CR + Placebo|"Coreg CR + placebo~carvedilol phosphate : Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months"
1103690|NCT00553969|P1|Participant Flow|1 Coreg CR + Lisinopril|"Coreg CR + lisinopril~carvedilol phosphate and lisinopril : carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
1103691|NCT00553969|O4|Outcome|4 Placebo + Placebo|
1103692|NCT00553969|O3|Outcome|3 Lisinopril + Placebo|"lisinopril + placebo~lisinopril : tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
1103693|NCT00553969|O2|Outcome|2 Coreg CR + Placebo|"Coreg CR + placebo~carvedilol phosphate : Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months"
1103694|NCT00553969|O1|Outcome|1 Coreg CR + Lisinopril|"Coreg CR + lisinopril~carvedilol phosphate and lisinopril : carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
1103695|NCT00553969|E4|Reported Event|4 Placebo + Placebo|
1103696|NCT00553969|E3|Reported Event|3 Lisinopril + Placebo|"lisinopril + placebo~lisinopril : tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
1103697|NCT00553969|E2|Reported Event|2 Coreg CR + Placebo|"Coreg CR + placebo~carvedilol phosphate : Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months"
1103698|NCT00553969|E1|Reported Event|1 Coreg CR + Lisinopril|"Coreg CR + lisinopril~carvedilol phosphate and lisinopril : carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
1103699|NCT00553839|B1|Baseline|Ketamine|"Then a 2 mg/kg IV bolus of Ketamine hydrochloride will be given.~ketamine hydrochloride: Open label pharmacokinetic study to be conducted in infants and children presenting for medical procedures (eg., surgery or cardiac catheterization). After the start of the procedure, a 0.5 cc preload blood sample (T0) will be drawn from an IV line. Then a 2 mg/kg IV bolus of Ketamine will be administered over 5 minutes. Timed 0.5 ml blood samples will be drawn at the following intervals: 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus."
1103700|NCT00553839|P1|Participant Flow|Single Group Assignment|
1103701|NCT00553839|O1|Outcome|Single Group Assignment|
1103702|NCT00553839|O1|Outcome|Single Group Assignment|
1103703|NCT00553839|O1|Outcome|Single Group Assignment|
1103704|NCT00553839|E1|Reported Event|Single Group Assignment|
1103705|NCT00553787|B4|Baseline|Total|Total of all reporting groups
1103706|NCT00553787|B3|Baseline|VI-0521 Top|15 mg/92 mg phentermine/topiramate
1103707|NCT00553787|B2|Baseline|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
1103708|NCT00553787|B1|Baseline|Placebo|
1103709|NCT00553787|P3|Participant Flow|VI-0521 Top|15 mg/92 mg phentermine/topiramate
1103710|NCT00553787|P2|Participant Flow|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
1103711|NCT00553787|P1|Participant Flow|Placebo|
1103712|NCT00553787|O3|Outcome|VI-0521 Top|15 mg/92 mg phentermine/topiramate
1103713|NCT00553787|O2|Outcome|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
1103714|NCT00553787|O1|Outcome|Placebo|
1103715|NCT00553787|O3|Outcome|VI-0521 Top|15 mg/92 mg phentermine/topiramate
1103716|NCT00553787|O2|Outcome|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
1103717|NCT00553787|O1|Outcome|Placebo|
1103718|NCT00553787|E3|Reported Event|VI-0521 Top|15 mg/92 mg phentermine/topiramate
1103721|NCT00553735|B1|Baseline|Arm I|"The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Cyclosporine A 0.05% : Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
1103722|NCT00553735|P1|Participant Flow|All Study Participants|"Each eye of every participant was randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive placebo (Artificial Tear)~The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Cyclosporine A 0.05% : Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
1103723|NCT00553735|O2|Outcome|Artificial Tear|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)~The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Arificial Tear: Artificial Tear - three times a day for 18 months."
1103724|NCT00553735|O1|Outcome|Cyclosporine A 0.05%|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)~The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Cyclosporine A 0.05%: Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
1103725|NCT00553735|O2|Outcome|Artificial Tear|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)~The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Arificial Tear: Artificial Tear - three times a day for 18 months."
1103726|NCT00553735|O1|Outcome|Cyclosporine A 0.05%|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)~The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Cyclosporine A 0.05%: Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
1103727|NCT00553735|O2|Outcome|Artificial Tear|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)~The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Arificial Tear: Artificial Tear - three times a day for 18 months."
1103728|NCT00553735|O1|Outcome|Cyclosporine A 0.05%|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)~The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Cyclosporine A 0.05%: Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
1103729|NCT00553735|O2|Outcome|Artificial Tear|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)~The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Arificial Tear: Artificial Tear - three times a day for 18 months."
1103773|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + Cisplatin + S-1 (MTD Expansion Cohort)|Subset of Sunitinib 25 mg 2/2 + Cisplatin + S-1 arm consisted of participants who were additionally enrolled after the maximum tolerated dose (MTD) of sunitinib was determined as 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment
1103730|NCT00553735|O1|Outcome|Cyclosporine A 0.05%|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)~The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Cyclosporine A 0.05%: Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
1103731|NCT00553735|O2|Outcome|Artificial Tear|"The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Artificial Tear three times a day for 18 months."
1103732|NCT00553735|O1|Outcome|Cyclosporine A 0.05%|"The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Cyclosporine A 0.05% : Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
1103733|NCT00553735|O2|Outcome|Artificial Tear|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)~The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Arificial Tear: Artificial Tear - three times a day for 18 months."
1103734|NCT00553735|O1|Outcome|Cyclosporine A 0.05%|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)~The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Cyclosporine A 0.05%: Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
1103735|NCT00553735|O2|Outcome|Artificial Tear|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)~The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Arificial Tear: Artificial Tear - three times a day for 18 months."
1103808|NCT00553631|E2|Reported Event|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
1103736|NCT00553735|O1|Outcome|Cyclosporine A 0.05%|"If patients pass the screening criteria, both eyes are randomized to therapy. One eye will receive Cyclosporine A 0.05% (Restasis) and the other eye will receive Placebo (Artificial Tear)~The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Cyclosporine A 0.05%: Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
1103737|NCT00553735|E1|Reported Event|Arm I|"The objective signs will be corneal and conjunctival staining, Schirmer test (with and without anesthesia), and tear break-up time. The subjective endpoints will be the SANDE symptom global score.~Cyclosporine A 0.05% : Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months."
1103738|NCT00553696|B5|Baseline|Total|Total of all reporting groups
1103739|NCT00553696|B4|Baseline|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
1103740|NCT00553696|B3|Baseline|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
1103741|NCT00553696|B2|Baseline|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
1103742|NCT00553696|B1|Baseline|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
1103743|NCT00553696|P4|Participant Flow|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
1103744|NCT00553696|P3|Participant Flow|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
1103745|NCT00553696|P2|Participant Flow|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
1103746|NCT00553696|P1|Participant Flow|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
1103747|NCT00553696|O4|Outcome|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
1103748|NCT00553696|O3|Outcome|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
1103749|NCT00553696|O2|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
1103750|NCT00553696|O1|Outcome|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
1104219|NCT00552669|B1|Baseline|Oral Sirolimus + Bare Metal Stent|Oral sirolimus plus bare metal stent implantation
1103751|NCT00553696|O4|Outcome|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
1103752|NCT00553696|O3|Outcome|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
1103753|NCT00553696|O2|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
1103754|NCT00553696|O1|Outcome|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
1103755|NCT00553696|O4|Outcome|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
1103756|NCT00553696|O3|Outcome|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
1103757|NCT00553696|O2|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
1103758|NCT00553696|O1|Outcome|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
1103759|NCT00553696|O4|Outcome|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
1104109|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
1103760|NCT00553696|O3|Outcome|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
1103761|NCT00553696|O2|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
1103762|NCT00553696|O1|Outcome|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
1103763|NCT00553696|O4|Outcome|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
1103809|NCT00553631|E1|Reported Event|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
1103810|NCT00553605|B3|Baseline|Total|Total of all reporting groups
1104220|NCT00552669|P2|Participant Flow|Drug Eluting Stents|Any Drug Eluting Stents
1103764|NCT00553696|O3|Outcome|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
1103765|NCT00553696|O2|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
1103766|NCT00553696|O1|Outcome|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
1103767|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
1103768|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
1103769|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
1103770|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
1103771|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
1103772|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
1103774|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + Cisplatin + S-1 (MTD Expansion Cohort)|Subset of Sunitinib 25 mg 2/2 + Cisplatin + S-1 arm consisted of participants who were additionally enrolled after the maximum tolerated dose (MTD) of sunitinib was determined as 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment
1103775|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + Cisplatin + S-1 (MTD Expansion Cohort)|Subset of Sunitinib 25 mg 2/2 + Cisplatin + S-1 arm consisted of participants who were additionally enrolled after the maximum tolerated dose (MTD) of sunitinib was determined as 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment
1103776|NCT00553696|O3|Outcome|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
1103777|NCT00553696|O2|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (Dose Escalation Cohort)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily regimen for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
1103778|NCT00553696|O1|Outcome|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
1104498|NCT00552175|P1|Participant Flow|Placebo|placebo comparator taken orally every day
1103779|NCT00553696|E4|Reported Event|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
1103780|NCT00553696|E3|Reported Event|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
1103781|NCT00553696|E2|Reported Event|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
1103782|NCT00553696|E1|Reported Event|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
1103783|NCT00553644|B1|Baseline|Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)|"Patients receive induction therapy comprising bortezomib 1.3mg/m^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.~bortezomib: Given IV~lenalidomide: Given PO"
1103784|NCT00553644|P1|Participant Flow|Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)|"Patients receive induction therapy comprising bortezomib 1.3mg/m^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.~bortezomib: Given IV~lenalidomide: Given PO"
1103785|NCT00553644|O1|Outcome|Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)|"Patients receive induction therapy comprising bortezomib 1.3mg/m^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.~bortezomib: Given IV~lenalidomide: Given PO"
1103786|NCT00553644|E1|Reported Event|Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)|lenalidomide: Given PO
1103787|NCT00553631|B3|Baseline|Total|Total of all reporting groups
1103788|NCT00553631|B2|Baseline|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
1103789|NCT00553631|B1|Baseline|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
1103790|NCT00553631|P2|Participant Flow|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
1103791|NCT00553631|P1|Participant Flow|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 unit per kilogram (U/kg) administered intravenously (IV) every other week for 39 weeks.
1103792|NCT00553631|O2|Outcome|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
1104110|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
1103795|NCT00553631|O1|Outcome|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
1103796|NCT00553631|O2|Outcome|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
1103797|NCT00553631|O1|Outcome|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
1103798|NCT00553631|O2|Outcome|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
1103799|NCT00553631|O1|Outcome|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
1103800|NCT00553631|O2|Outcome|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
1103801|NCT00553631|O1|Outcome|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
1103802|NCT00553631|O2|Outcome|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
1103803|NCT00553631|O1|Outcome|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
1103804|NCT00553631|O2|Outcome|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
1103805|NCT00553631|O1|Outcome|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
1103806|NCT00553631|O2|Outcome|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
1103807|NCT00553631|O1|Outcome|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
1106931|NCT00546871|O5|Outcome|Study Extension, SC Administration|
1103811|NCT00553605|B2|Baseline|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
1103812|NCT00553605|B1|Baseline|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
1103813|NCT00553605|P2|Participant Flow|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
1103814|NCT00553605|P1|Participant Flow|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
1103815|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
1103816|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
1103817|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
1103818|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
1103819|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
1103820|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
1103821|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
1103822|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
1103823|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
1103824|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
1103825|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
1103826|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
1103827|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
1103828|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
1103829|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
1103830|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
1104111|NCT00553267|O1|Outcome|Amlodipine 10mg|
1103831|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
1103832|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
1103833|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
1103834|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
1103835|NCT00553605|E2|Reported Event|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
1103836|NCT00553605|E1|Reported Event|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
1103837|NCT00553514|B6|Baseline|Total|Total of all reporting groups
1103838|NCT00553514|B5|Baseline|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103916|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103839|NCT00553514|B4|Baseline|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103840|NCT00553514|B3|Baseline|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103841|NCT00553514|B2|Baseline|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103842|NCT00553514|B1|Baseline|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103843|NCT00553514|P5|Participant Flow|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103844|NCT00553514|P4|Participant Flow|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103845|NCT00553514|P3|Participant Flow|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103846|NCT00553514|P2|Participant Flow|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1104112|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
1104113|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
1103847|NCT00553514|P1|Participant Flow|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103848|NCT00553514|O5|Outcome|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103849|NCT00553514|O4|Outcome|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1104499|NCT00552175|O3|Outcome|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
1103850|NCT00553514|O3|Outcome|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103851|NCT00553514|O2|Outcome|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103852|NCT00553514|O1|Outcome|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103853|NCT00553514|O5|Outcome|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103854|NCT00553514|O4|Outcome|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103855|NCT00553514|O3|Outcome|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103856|NCT00553514|O2|Outcome|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103857|NCT00553514|O1|Outcome|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1104114|NCT00553267|O1|Outcome|Amlodipine 10mg|
1103858|NCT00553514|O5|Outcome|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103859|NCT00553514|O4|Outcome|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103860|NCT00553514|O3|Outcome|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103917|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103861|NCT00553514|O2|Outcome|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103862|NCT00553514|O1|Outcome|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103863|NCT00553514|O5|Outcome|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103864|NCT00553514|O4|Outcome|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103865|NCT00553514|O3|Outcome|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103866|NCT00553514|O2|Outcome|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103867|NCT00553514|O1|Outcome|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103868|NCT00553514|O5|Outcome|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103906|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103907|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1104115|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
1103869|NCT00553514|O4|Outcome|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103870|NCT00553514|O3|Outcome|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103918|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103919|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103920|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103871|NCT00553514|O2|Outcome|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103872|NCT00553514|O1|Outcome|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103873|NCT00553514|O5|Outcome|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103874|NCT00553514|O4|Outcome|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103875|NCT00553514|O3|Outcome|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103876|NCT00553514|O2|Outcome|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103877|NCT00553514|O1|Outcome|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103878|NCT00553514|E5|Reported Event|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103879|NCT00553514|E4|Reported Event|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103908|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1104116|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
1103880|NCT00553514|E3|Reported Event|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103881|NCT00553514|E2|Reported Event|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103882|NCT00553514|E1|Reported Event|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
1103883|NCT00553501|B1|Baseline|Epratuzumab Plus Rituximab|"Induction Therapy (Month 1):~Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22~Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36"
1103884|NCT00553501|P1|Participant Flow|Epratuzumab Plus Rituximab|"Induction Therapy (Month 1):~Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22~Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36"
1103885|NCT00553501|O1|Outcome|Epratuzumab Plus Rituximab|"Induction Therapy (Month 1):~Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22~Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36"
1103886|NCT00553501|O1|Outcome|Epratuzumab Plus Rituximab|"Induction Therapy (Month 1):~Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22~Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36"
1103887|NCT00553501|O1|Outcome|Epratuzumab Plus Rituximab|"Induction Therapy (Month 1):~Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22~Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36"
1103888|NCT00553501|E1|Reported Event|Epratuzumab Plus Rituximab|"Induction Therapy (Month 1):~Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22~Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36"
1103889|NCT00553475|B4|Baseline|Total|Total of all reporting groups
1103890|NCT00553475|B3|Baseline|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103891|NCT00553475|B2|Baseline|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103892|NCT00553475|B1|Baseline|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103893|NCT00553475|P3|Participant Flow|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103894|NCT00553475|P2|Participant Flow|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103895|NCT00553475|P1|Participant Flow|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103896|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103897|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103898|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103899|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103900|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103901|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103902|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103903|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103904|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103905|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1104117|NCT00553267|O1|Outcome|Amlodipine 10mg|
1103909|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103910|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103911|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103912|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103913|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103914|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103915|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103921|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103922|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103923|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103924|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103925|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103926|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103927|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103928|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103929|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103930|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103931|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103932|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103933|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103934|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103935|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103936|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103937|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103938|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103939|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103940|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103941|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103942|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103943|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103944|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103945|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103946|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103947|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103948|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103949|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103950|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103951|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103952|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103953|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103954|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103955|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103956|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103957|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103958|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103959|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103960|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103961|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103962|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103963|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103964|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103965|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103966|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103967|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103968|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103969|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103970|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103971|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103972|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103973|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103974|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103975|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103976|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103977|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103978|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103979|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103980|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103981|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103982|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103983|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103984|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103985|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103986|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103987|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103988|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103989|NCT00553475|O3|Outcome|Expected Exposure Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr in the pregabalin 300 and 600 mg/day groups received pregabalin 300 mg/day and subjects with normal CLcr in the pregabalin 600 mg/day group received pregabalin 600 mg/day for 12 weeks.
1103990|NCT00553475|O2|Outcome|Expected Exposure Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with normal CLcr in the pregabalin 300 mg/day group received pregabalin 300 mg/day for 12 weeks.
1103991|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103992|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103993|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103994|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1103995|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103996|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1103997|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1106932|NCT00546871|O4|Outcome|Study Part 3b, SC Administration|
1103998|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1103999|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1104000|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1104001|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1104002|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1104003|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1104004|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1104005|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1104006|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1104007|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1104008|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1104009|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1104010|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1104011|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1104012|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1104013|NCT00553475|E3|Reported Event|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1104014|NCT00553475|E2|Reported Event|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1104015|NCT00553475|E1|Reported Event|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1104016|NCT00553462|B1|Baseline|Paclitaxel + Carboplatin + Radiation + Erlotinib|"Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.~Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy."
1104017|NCT00553462|P1|Participant Flow|Paclitaxel + Carboplatin + Radiation + Erlotinib|"Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.~Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy."
1104018|NCT00553462|O1|Outcome|Paclitaxel + Carboplatin + Radiation + Erlotinib|"Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.~Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy."
1104046|NCT00553358|O1|Outcome|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
1104118|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
1104019|NCT00553462|O1|Outcome|Paclitaxel + Carboplatin + Radiation + Erlotinib|"Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.~Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy."
1104020|NCT00553462|O1|Outcome|Paclitaxel + Carboplatin + Radiation + Erlotinib|"Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.~Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy."
1104021|NCT00553462|E1|Reported Event|Paclitaxel + Carboplatin + Radiation + Erlotinib|"Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.~Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy."
1104022|NCT00553436|B1|Baseline|Enrolled Subjects Treated With Tissue Apposition System (TAS)|All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
1104023|NCT00553436|P1|Participant Flow|Enrolled Subjects Treated With Tissue Apposition System (TAS)|All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
1104024|NCT00553436|O1|Outcome|Enrolled Subjects Treated With Tissue Apposition System (TAS)|All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
1104025|NCT00553436|O1|Outcome|Enrolled Subjects Treated With Tissue Apposition System (TAS)|All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
1104026|NCT00553436|O1|Outcome|Enrolled Subjects Treated With Tissue Apposition System (TAS)|All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
1104027|NCT00553436|E1|Reported Event|Enrolled Subjects Treated With Tissue Apposition System (TAS)|All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
1104028|NCT00553358|B4|Baseline|Total|Total of all reporting groups
1104029|NCT00553358|B3|Baseline|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
1104030|NCT00553358|B2|Baseline|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
1104031|NCT00553358|B1|Baseline|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenously (IV) for an additional 12 weeks
1104032|NCT00553358|P3|Participant Flow|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
1104033|NCT00553358|P2|Participant Flow|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
1104034|NCT00553358|P1|Participant Flow|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenously (IV) for an additional 12 weeks
1104035|NCT00553358|O3|Outcome|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
1104036|NCT00553358|O2|Outcome|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
1104037|NCT00553358|O1|Outcome|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
1104038|NCT00553358|O3|Outcome|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
1104039|NCT00553358|O2|Outcome|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
1104040|NCT00553358|O1|Outcome|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
1104041|NCT00553358|O3|Outcome|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
1104042|NCT00553358|O2|Outcome|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
1104043|NCT00553358|O1|Outcome|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
1104044|NCT00553358|O3|Outcome|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
1104045|NCT00553358|O2|Outcome|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
1104081|NCT00553319|E3|Reported Event|Adderall-XR 80 mg|"Adderall-XR 80 mg~Adderall-XR: Adderall-XR 80mg/day"
1104047|NCT00553358|O3|Outcome|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
1104048|NCT00553358|O2|Outcome|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
1104049|NCT00553358|O1|Outcome|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
1104050|NCT00553358|O3|Outcome|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
1104051|NCT00553358|O2|Outcome|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
1104052|NCT00553358|O1|Outcome|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
1104053|NCT00553358|O3|Outcome|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
1104054|NCT00553358|O2|Outcome|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
1106933|NCT00546871|O3|Outcome|Study Part 3a, SC Administration|
1104055|NCT00553358|O1|Outcome|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
1104056|NCT00553358|E3|Reported Event|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
1104057|NCT00553358|E2|Reported Event|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
1104058|NCT00553358|E1|Reported Event|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
1104059|NCT00553332|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~selumetinib: Given orally~laboratory biomarker analysis: Correlative studies"
1104060|NCT00553332|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~selumetinib: Given orally~laboratory biomarker analysis: Correlative studies"
1104061|NCT00553332|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~selumetinib: Given orally~laboratory biomarker analysis: Correlative studies"
1104062|NCT00553332|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~selumetinib: Given orally~laboratory biomarker analysis: Correlative studies"
1104063|NCT00553332|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~selumetinib: Given orally~laboratory biomarker analysis: Correlative studies"
1104064|NCT00553332|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~selumetinib: Given orally~laboratory biomarker analysis: Correlative studies"
1104065|NCT00553332|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~selumetinib: Given orally~laboratory biomarker analysis: Correlative studies"
1104066|NCT00553332|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~selumetinib: Given orally~laboratory biomarker analysis: Correlative studies"
1104067|NCT00553332|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~selumetinib: Given orally~laboratory biomarker analysis: Correlative studies"
1104068|NCT00553319|B4|Baseline|Total|Total of all reporting groups
1104069|NCT00553319|B3|Baseline|Adderall-XR 80 mg|"Adderall-XR 80 mg~Adderall-XR: Adderall-XR 80mg/day"
1104070|NCT00553319|B2|Baseline|Adderall-XR 60 mg|"Adderall-XR 60 mg~Adderall-XR: Adderall-XR 60mg/day"
1104071|NCT00553319|B1|Baseline|Placebo|"Placebo~Placebo: Placebo group"
1104072|NCT00553319|P3|Participant Flow|Adderall-XR 80 mg|"Adderall-XR 80 mg~Adderall-XR: Adderall-XR 80mg/day"
1104073|NCT00553319|P2|Participant Flow|Adderall-XR 60 mg|"Adderall-XR 60 mg~Adderall-XR: Adderall-XR 60mg/day"
1104074|NCT00553319|P1|Participant Flow|Placebo|"Placebo~Placebo: Placebo group"
1104075|NCT00553319|O3|Outcome|Adderall-XR 80 mg|"Adderall-XR 80 mg~Adderall-XR: Adderall-XR 80mg/day"
1104076|NCT00553319|O2|Outcome|Adderall-XR 60 mg|"Adderall-XR 60 mg~Adderall-XR: Adderall-XR 60mg/day"
1104077|NCT00553319|O1|Outcome|Placebo|"Placebo~Placebo: Placebo group"
1104078|NCT00553319|O3|Outcome|Adderall-XR 80 mg|"Adderall-XR 80 mg~Adderall-XR: Adderall-XR 80mg/day"
1104079|NCT00553319|O2|Outcome|Adderall-XR 60 mg|"Adderall-XR 60 mg~Adderall-XR: Adderall-XR 60mg/day"
1104080|NCT00553319|O1|Outcome|Placebo|"Placebo~Placebo: Placebo group"
1104084|NCT00553280|B1|Baseline|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
1104085|NCT00553280|P1|Participant Flow|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
1104086|NCT00553280|O1|Outcome|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
1104205|NCT00552760|E1|Reported Event|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
1104206|NCT00552695|B3|Baseline|Total|Total of all reporting groups
1104087|NCT00553280|O1|Outcome|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
1104088|NCT00553280|O1|Outcome|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
1104089|NCT00553280|O1|Outcome|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
1104090|NCT00553280|O1|Outcome|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
1104091|NCT00553280|O1|Outcome|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
1104092|NCT00553280|E1|Reported Event|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
1104093|NCT00553267|B4|Baseline|Total|Total of all reporting groups
1104094|NCT00553267|B3|Baseline|Telmisartan 80mg and Amlodipine 10mg|
1104095|NCT00553267|B2|Baseline|Telmisartan 40mg and Amlodipine 10mg|
1104096|NCT00553267|B1|Baseline|Amlodipine 10mg|
1104097|NCT00553267|P3|Participant Flow|Telmisartan 80mg and Amlodipine 10mg|
1104098|NCT00553267|P2|Participant Flow|Telmisartan 40mg and Amlodipine 10mg|
1104099|NCT00553267|P1|Participant Flow|Amlodipine 10mg|
1104100|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
1104101|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
1104102|NCT00553267|O1|Outcome|Amlodipine 10mg|
1104103|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
1104104|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
1104105|NCT00553267|O1|Outcome|Amlodipine 10mg|
1104106|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
1104107|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
1104108|NCT00553267|O1|Outcome|Amlodipine 10mg|
1104125|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
1104126|NCT00553267|O1|Outcome|Amlodipine 10mg|
1104127|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
1104128|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
1104129|NCT00553267|O1|Outcome|Amlodipine 10mg|
1104130|NCT00553267|E3|Reported Event|Telmisartan 80mg and Amlodipine 10mg|
1104131|NCT00553267|E2|Reported Event|Telmisartan 40mg and Amlodipine 10mg|
1104132|NCT00553267|E1|Reported Event|Amlodipine 10mg|
1104133|NCT00553202|B1|Baseline|Treatment (Chemotherapy and Allogeneic SCT)|All Patients
1104134|NCT00553202|P1|Participant Flow|Treatment (Chemotherapy and Allogeneic SCT)|All patients
1104135|NCT00553202|O1|Outcome|Treatment (Chemotherapy and Allogeneic SCT)|All patients
1104136|NCT00553202|O1|Outcome|Treatment (Chemotherapy and Allogeneic SCT)|All patients
1104137|NCT00553202|O1|Outcome|Treatment (Chemotherapy and Allogeneic SCT)|All patients
1104138|NCT00553202|O1|Outcome|Treatment (Chemotherapy and Allogeneic SCT)|All Patients
1104139|NCT00553202|O1|Outcome|Treatment (Chemotherapy and Allogeneic SCT)|All Patients
1104140|NCT00553202|E1|Reported Event|Group 1|All patients
1104141|NCT00553150|B3|Baseline|Total|Total of all reporting groups
1104207|NCT00552695|B2|Baseline|Control Patch|Warm patch with no active substances
1104208|NCT00552695|B1|Baseline|LIDODERM Patch|Lidocaine 70 mg/tetracaine 70 mg skin patch
1104209|NCT00552695|P2|Participant Flow|Control Patch|Warm patch with no active substances
1104210|NCT00552695|P1|Participant Flow|LIDODERM Patch|Lidocaine 70 mg/tetracaine 70 mg skin patch
1104142|NCT00553150|B2|Baseline|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
1104143|NCT00553150|B1|Baseline|Phase I|Cycle 1: Everolimus (either: 30, 50, or 70 mg) days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus (either: 30, 50, or 70 mg)/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
1104144|NCT00553150|P4|Participant Flow|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
1104145|NCT00553150|P3|Participant Flow|Phase 1: Cohort/Dose Level 3 (70 mg RAD001)|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
1104146|NCT00553150|P2|Participant Flow|Phase I: Cohort/Dose Level 2 (50 mg RAD001)|Cycle 1: Everolimus 50 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 50 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
1104147|NCT00553150|P1|Participant Flow|Phase I: Cohort/Dose Level 1 (30 mg RAD001)|Cycle 1: Everolimus 30 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 30 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
1104148|NCT00553150|O1|Outcome|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
1104149|NCT00553150|O1|Outcome|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
1104150|NCT00553150|O1|Outcome|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
1104188|NCT00552786|E1|Reported Event|N-acetylcysteine (NAC)|Formulation NAC (1200 mg/day, 14 days) (Actein, Synmosa Corp., Taiwan) administered in either first intervention period or second intervention period.
1104151|NCT00553150|O1|Outcome|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
1104152|NCT00553150|O1|Outcome|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
1104211|NCT00552695|O2|Outcome|Control Patch|Warm patch with no active substances
1104212|NCT00552695|O1|Outcome|LIDODERM Patch|Lidocaine 70 mg/tetracaine 70 mg skin patch
1104213|NCT00552695|O2|Outcome|Control Patch|Warm patch with no active substances
1104214|NCT00552695|O1|Outcome|LIDODERM Patch|Lidocaine 70 mg/tetracaine 70 mg skin patch
1104153|NCT00553150|O3|Outcome|Phase I: Dose Level 2|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
1104154|NCT00553150|O2|Outcome|Phase I: Dose Level 1|Cycle 1: Everolimus 50 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 50 mg)/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
1104155|NCT00553150|O1|Outcome|Phase I: Dose Level 0|Cycle 1: Everolimus 30 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 30 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
1104156|NCT00553150|E2|Reported Event|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
1104157|NCT00553150|E1|Reported Event|Phase I|Cycle 1: Everolimus (either: 30, 50, or 70 mg) days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus (either: 30, 50, or 70 mg)/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
1104158|NCT00553098|B1|Baseline|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
1104159|NCT00553098|P1|Participant Flow|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
1104160|NCT00553098|O1|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
1104189|NCT00552760|B3|Baseline|Total|Total of all reporting groups
1104161|NCT00553098|O1|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
1104215|NCT00552695|E2|Reported Event|Control Patch|Warm patch with no active substances
1104216|NCT00552695|E1|Reported Event|LIDODERM Patch|Lidocaine 70 mg/tetracaine 70 mg skin patch
1104162|NCT00553098|O1|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
1104163|NCT00553098|O1|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
1104164|NCT00553098|O1|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoietic Ste"
1104165|NCT00553098|O1|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoietic"
1104166|NCT00553098|O1|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
1104167|NCT00553098|O1|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoietic S"
1104190|NCT00552760|B2|Baseline|Placebo|one tablet at bedtime for up to 6 months
1104191|NCT00552760|B1|Baseline|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
1104192|NCT00552760|P2|Participant Flow|Placebo|one tablet at bedtime for up to 6 months
1104193|NCT00552760|P1|Participant Flow|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
1104168|NCT00553098|O1|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoietic S"
1104169|NCT00553098|O1|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
1104170|NCT00553098|O1|Outcome|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
1104171|NCT00553098|E1|Reported Event|Treatment (Chemotherapy, Low Dose Radiation)|"CONDITIONING REGIMEN: *Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.~HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.~Alemtuzumab: Given IV~Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet"
1104172|NCT00552812|B1|Baseline|Coarctation Stenting|Stent enlargement of aortic coarctation : Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
1104173|NCT00552812|P1|Participant Flow|Coarctation Stenting|Stent enlargement of aortic coarctation : Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
1104174|NCT00552812|O1|Outcome|Coarctation Stenting|Stent enlargement of aortic coarctation: Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
1104175|NCT00552812|O1|Outcome|Coarctation Stenting|Stent enlargement of aortic coarctation: Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
1104176|NCT00552812|O1|Outcome|Coarctation Stenting|Stent enlargement of aortic coarctation: Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
1104177|NCT00552812|E1|Reported Event|Coarctation Stenting|Stent enlargement of aortic coarctation : Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
1104178|NCT00552786|B3|Baseline|Total|Total of all reporting groups
1104179|NCT00552786|B2|Baseline|Placebo First, Then N-acetylcysteine (NAC)|Placebo in the first intervention period and Formulation NAC in the second intervention period (after washout period).
1104180|NCT00552786|B1|Baseline|N-acetylcysteine (NAC) First, Then Placebo|Formulation NAC (1200 mg/day, 14 days) (Actein, Synmosa Corp., Taiwan) in the first intervention period and Placebo (a tablet of identical taste and odor to the NAC agent) in the second intervention period (after washout period).
1104181|NCT00552786|P2|Participant Flow|Placebo First, Then N-acetylcysteine (NAC)|Placebo in the first intervention period and Formulation NAC in the second intervention period (after washout period).
1104182|NCT00552786|P1|Participant Flow|N-acetylcysteine (NAC) First, Then Placebo|Formulation NAC (1200 mg/day, 14 days) (Actein, Synmosa Corp., Taiwan) in the first intervention period and Placebo (a tablet of identical taste and odor to the NAC agent) in the second intervention period (after washout period).
1104183|NCT00552786|O2|Outcome|Placebo|Placebo administered once daily in either first intervention period or second intervention period.
1104184|NCT00552786|O1|Outcome|N-acetylcysteine (NAC)|Formulation NAC (1200 mg/day, 14 days) (Actein, Synmosa Corp., Taiwan) administered in either first intervention period or second intervention period.
1104185|NCT00552786|O2|Outcome|Placebo|Placebo administered once daily in either first intervention period or second intervention period.
1104186|NCT00552786|O1|Outcome|N-acetylcysteine (NAC)|Formulation NAC (1200 mg/day, 14 days) (Actein, Synmosa Corp., Taiwan) administered in either first intervention period or second intervention period.
1104187|NCT00552786|E2|Reported Event|Placebo|Placebo administered once daily in either first intervention period or second intervention period.
1104194|NCT00552760|O2|Outcome|Placebo|one tablet at bedtime for up to 6 months
1104195|NCT00552760|O1|Outcome|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
1104196|NCT00552760|O2|Outcome|Placebo|one tablet at bedtime for up to 6 months
1104197|NCT00552760|O1|Outcome|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
1104198|NCT00552760|O2|Outcome|Placebo|one tablet at bedtime for up to 6 months
1104199|NCT00552760|O1|Outcome|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
1104200|NCT00552760|O2|Outcome|Placebo|one tablet at bedtime for up to 6 months
1104201|NCT00552760|O1|Outcome|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
1104202|NCT00552760|O2|Outcome|Placebo|one tablet at bedtime for up to 6 months
1104203|NCT00552760|O1|Outcome|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
1104204|NCT00552760|E2|Reported Event|Placebo|one tablet at bedtime for up to 6 months
1104221|NCT00552669|P1|Participant Flow|Oral Sirolimus + Bare Metal Stent|Oral sirolimus plus bare metal stent implantation
1104222|NCT00552669|O2|Outcome|Drug Eluting Stents|Any Drug Eluting Stents
1104223|NCT00552669|O1|Outcome|Oral Sirolimus + Bare Metal Stent|Oral sirolimus plus bare metal stent implantation
1104224|NCT00552669|O2|Outcome|Drug Eluting Stents|Any Drug Eluting Stents
1104225|NCT00552669|O1|Outcome|Oral Sirolimus + Bare Metal Stent|Oral sirolimus plus bare metal stent implantation
1104226|NCT00552669|O2|Outcome|Drug Eluting Stents|Any Drug Eluting Stents
1104227|NCT00552669|O1|Outcome|Oral Sirolimus + Bare Metal Stent|Oral sirolimus plus bare metal stent implantation
1104228|NCT00552669|E2|Reported Event|Drug Eluting Stents|Any Drug Eluting Stents
1104229|NCT00552669|E1|Reported Event|Oral Sirolimus + Bare Metal Stent|Oral sirolimus plus bare metal stent implantation
1104230|NCT00552578|B3|Baseline|Total|Total of all reporting groups
1104231|NCT00552578|B2|Baseline|Steady Dose of Buprenorphine|Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
1104232|NCT00552578|B1|Baseline|Tapering Doses of Buprenorphine|Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
1104233|NCT00552578|P2|Participant Flow|Steady Dose of Buprenorphine|Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
1104234|NCT00552578|P1|Participant Flow|Tapering Doses of Buprenorphine|Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
1104235|NCT00552578|O2|Outcome|Steady Dose of Buprenorphine|Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
1104236|NCT00552578|O1|Outcome|Tapering Doses of Buprenorphine|Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
1104237|NCT00552578|O2|Outcome|Steady Dose of Buprenorphine|Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
1104238|NCT00552578|O1|Outcome|Tapering Doses of Buprenorphine|Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
1104239|NCT00552578|O2|Outcome|Steady Dose of Buprenorphine|Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
1104240|NCT00552578|O1|Outcome|Tapering Doses of Buprenorphine|Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
1104241|NCT00552578|E2|Reported Event|Steady Dose of Buprenorphine|Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
1104242|NCT00552578|E1|Reported Event|Tapering Doses of Buprenorphine|Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
1104243|NCT00552513|B3|Baseline|Total|Total of all reporting groups
1104244|NCT00552513|B2|Baseline|Delayed|Delayed intervention: Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) any time after 36 hours after randomisation.
1104245|NCT00552513|B1|Baseline|Early|Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) as soon as possible (within 24 hours of randomisation).
1104246|NCT00552513|P2|Participant Flow|Delayed|Delayed intervention: Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) any time after 36 hours after randomisation.
1104247|NCT00552513|P1|Participant Flow|Early|Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) as soon as possible (within 24 hours of randomisation).
1104248|NCT00552513|O2|Outcome|Delayed Intervention|
1104249|NCT00552513|O1|Outcome|Early Intervention|
1104250|NCT00552513|O2|Outcome|Delayed Intervention|
1104251|NCT00552513|O1|Outcome|Early Intervention|
1104252|NCT00552513|O2|Outcome|Delayed Intervention|Coronary angiography to be performed after a minimum delay of 36 hours after randomization
1104288|NCT00552396|B4|Baseline|0.075 mg/kg|
1104253|NCT00552513|O1|Outcome|Early Intervention|Coronary angiography to be performed as rapidly as possible and within 24 hours after randomization
1104254|NCT00552513|E2|Reported Event|Delayed|Delayed intervention: Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) any time after 36 hours after randomisation.
1104255|NCT00552513|E1|Reported Event|Early|Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) as soon as possible (within 24 hours of randomisation).
1104256|NCT00552448|B3|Baseline|Total|Total of all reporting groups
1104257|NCT00552448|B2|Baseline|Pediatric Status Asthmaticus Patients Not Using HFCC|This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
1104258|NCT00552448|B1|Baseline|Pediatric Status Asthmatics Patients on HFCC Device|"Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received~High Frequency Chest Compression VEST: every 6 hours for 20 minutes"
1104259|NCT00552448|P2|Participant Flow|Pediatric Status Asthmaticus Patients Not Using HFCC|This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
1104260|NCT00552448|P1|Participant Flow|Pediatric Status Asthmatics Patients on HFCC Device|"Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received~High Frequency Chest Compression VEST: every 6 hours for 20 minutes"
1104261|NCT00552448|O2|Outcome|Pediatric Status Asthmaticus Patients Not Using HFCC|This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
1104262|NCT00552448|O1|Outcome|Pediatric Status Asthmatics Patients on HFCC Device|"Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received~High Frequency Chest Compression VEST: every 6 hours for 20 minutes"
1104263|NCT00552448|O2|Outcome|Pediatric Status Asthmaticus Patients Not Using HFCC|This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
1104264|NCT00552448|O1|Outcome|Pediatric Status Asthmatics Patients on HFCC Device|"Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received~High Frequency Chest Compression VEST: every 6 hours for 20 minutes"
1104265|NCT00552448|O2|Outcome|Pediatric Status Asthmaticus Patients Not Using HFCC|This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
1104266|NCT00552448|O1|Outcome|Pediatric Status Asthmatics Patients on HFCC Device|"Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received~High Frequency Chest Compression VEST: every 6 hours for 20 minutes"
1104267|NCT00552448|O2|Outcome|Pediatric Status Asthmaticus Patients Not Using HFCC|This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
1104268|NCT00552448|O1|Outcome|Pediatric Status Asthmatics Patients on HFCC Device|"Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received~High Frequency Chest Compression VEST: every 6 hours for 20 minutes"
1104269|NCT00552448|E2|Reported Event|Pediatric Status Asthmaticus Patients Not Using HFCC|This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
1104270|NCT00552448|E1|Reported Event|Pediatric Status Asthmatics Patients on HFCC Device|"Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received~High Frequency Chest Compression VEST: every 6 hours for 20 minutes"
1104271|NCT00552422|B1|Baseline|Domperidone Arm|"Study subjects will self-administer oral domperidone 10mg four times a day. If symptoms persist for more than 7 days, the investigator may increase the dose to 20mg four times a day. 20mg four times a day will be the maximal dose. Subjects with signiﬁcant renal impairment will received a starting dose of 10mg twice a day. The maximal dose in subjects with signiﬁcant renal impairment will be 20mg twice a day.~domperidone: 10mg orally four times per day"
1104272|NCT00552422|P1|Participant Flow|Domperidone Arm|"Study subjects will self-administer oral domperidone 10mg four times a day. If symptoms persist for more than 7 days, the investigator may increase the dose to 20mg four times a day. 20mg four times a day will be the maximal dose. Subjects with signiﬁcant renal impairment will received a starting dose of 10mg twice a day. The maximal dose in subjects with signiﬁcant renal impairment will be 20mg twice a day.~domperidone: 10mg orally four times per day"
1104273|NCT00552422|O1|Outcome|Domperidone Arm|"Study subjects will self-administer oral domperidone 10mg four times a day. If symptoms persist for more than 7 days, the investigator may increase the dose to 20mg four times a day. 20mg four times a day will be the maximal dose. Subjects with signiﬁcant renal impairment will received a starting dose of 10mg twice a day. The maximal dose in subjects with signiﬁcant renal impairment will be 20mg twice a day.~domperidone: 10mg orally four times per day"
1104274|NCT00552422|E1|Reported Event|Domperidone|Participants ranged from 18-65 years of age. Gender composition was 60$% female and 40% male.
1104275|NCT00552409|B3|Baseline|Total|Total of all reporting groups
1104276|NCT00552409|B2|Baseline|Placebo|One softgel daily for one year
1104277|NCT00552409|B1|Baseline|Cholecalciferol|2000 IU by mouth daily for one year
1104278|NCT00552409|P2|Participant Flow|Placebo|One softgel daily for one year
1104279|NCT00552409|P1|Participant Flow|Cholecalciferol|2000 IU by mouth daily for one year
1104280|NCT00552409|O2|Outcome|Placebo|One softgel daily for one year
1104281|NCT00552409|O1|Outcome|Cholecalciferol|2000 IU by mouth daily for one year
1104282|NCT00552409|E2|Reported Event|Placebo|One softgel daily for one year
1104283|NCT00552409|E1|Reported Event|Cholecalciferol|2000 IU by mouth daily for one year
1104284|NCT00552396|B8|Baseline|Total|Total of all reporting groups
1104285|NCT00552396|B7|Baseline|3 mg/kg|
1104286|NCT00552396|B6|Baseline|1 mg/kg|
1104287|NCT00552396|B5|Baseline|0.3 mg/kg|
1104289|NCT00552396|B3|Baseline|0.015 mg/kg|
1104290|NCT00552396|B2|Baseline|0.003 mg/kg|
1104291|NCT00552396|B1|Baseline|0.0003 mg/kg|
1104292|NCT00552396|P7|Participant Flow|3 mg/kg|
1104293|NCT00552396|P6|Participant Flow|1 mg/kg|
1104294|NCT00552396|P5|Participant Flow|0.3 mg/kg|
1104295|NCT00552396|P4|Participant Flow|0.075 mg/kg|
1104296|NCT00552396|P3|Participant Flow|0.015 mg/kg|
1104297|NCT00552396|P2|Participant Flow|0.003 mg/kg|
1104298|NCT00552396|P1|Participant Flow|0.0003 mg/kg|3+3 design was employed for the first dosing cycle at each dose level. The 7 dose levels were 0.0003 mg/kg, 0.003 mg/kg, 0.015 mg/kg, 0.075 mg/kg, 0.3 mg/kg, 1.0 mg/kg, and 3.0 mg/kg. The subjects received up to a total of 4 administrations of Anti-KIR (1-7F9) with a dosing interval between each administration of 4 weeks.
1104299|NCT00552396|O7|Outcome|IPH2101 3 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
1104300|NCT00552396|O6|Outcome|IPH2101 1 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
1104301|NCT00552396|O5|Outcome|IPH2101 0.3 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
1104302|NCT00552396|O4|Outcome|IPH2101 0.075 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
1104303|NCT00552396|O3|Outcome|IPH2101 0.015 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
1104336|NCT00552344|O1|Outcome|Certolizumab Pegol|Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
1104304|NCT00552396|O2|Outcome|IPH2101 0.003 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
1104305|NCT00552396|O1|Outcome|IPH2101 0.0003 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
1104306|NCT00552396|O7|Outcome|IPH2101 3 mg/kg|IV 1 hour infusion
1104307|NCT00552396|O6|Outcome|IPH2101 1 mg/kg|IV 1 hour infusion
1104308|NCT00552396|O5|Outcome|IPH2101 0.3mg/kg|IV 1 hour infusion
1104309|NCT00552396|O4|Outcome|IPH2101 0.075 mg/kg|IV 1 hour infusion
1104310|NCT00552396|O3|Outcome|IPH2101 0.015 mg/kg|IV bolus injection
1104311|NCT00552396|O2|Outcome|IPH2101 0.003 mg/kg|IV bolus injection
1104312|NCT00552396|O1|Outcome|IPH2101 0.0003 mg/kg|IV bolus injection
1104313|NCT00552396|O7|Outcome|IPH2101 3 mg/kg|IV 1 hour infusion
1104314|NCT00552396|O6|Outcome|IPH2101 1 mg/kg|IV 1 hour infusion
1104315|NCT00552396|O5|Outcome|IPH2101 0.3 mg/kg|IV 1 hour infusion
1104316|NCT00552396|O4|Outcome|IPH2101 0.075 mg/kg|IV 1 hour infusion
1104317|NCT00552396|O3|Outcome|IPH2101 0.015 mg/kg|IV Bolus
1104318|NCT00552396|O2|Outcome|IPH2101 0.003 mg/kg|IV Bolus
1104319|NCT00552396|O1|Outcome|IPH2101 0.0003 mg/kg|IV Bolus
1104320|NCT00552396|O7|Outcome|IPH2101 3 mg/kg|Participants were administered an IV dose of 3mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level.If MTD this is not reached at 3mg/kg, 7 subjects will be enrolled at this dose to obtain more data from a larger subject pool to better evaluate safety, PK, PD and signs of efficacy.
1104321|NCT00552396|O6|Outcome|IPH2101 1mg/kg|Participants were administered an IV dose of 1 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
1104322|NCT00552396|O5|Outcome|IPH2101 0.3mg/kg|Participants were administered an IV dose of 0.3mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
1104323|NCT00552396|O4|Outcome|IPH2101 0.075 mg/kg|Participants were administered an IV dose of 0.075 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
1104324|NCT00552396|O3|Outcome|IPH2101 0.015 mg/kg|Participants were administered an IV dose of 0.015 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
1104362|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1104363|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
1104364|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1104325|NCT00552396|O2|Outcome|IPH2101 0.003 mg/kg|Participants were administered an IV dose of 0.003 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
1104326|NCT00552396|O1|Outcome|IPH2101 0.0003 mg/kg|Participants were administered an IV dose of 0.0003 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
1104327|NCT00552396|E7|Reported Event|3 mg/kg|
1104328|NCT00552396|E6|Reported Event|1 mg/kg|
1104329|NCT00552396|E5|Reported Event|0.3 mg/kg|
1104330|NCT00552396|E4|Reported Event|0.075 mg/kg|
1104331|NCT00552396|E3|Reported Event|0.015 mg/kg|
1104332|NCT00552396|E2|Reported Event|0.003 mg/kg|
1104333|NCT00552396|E1|Reported Event|0.0003 mg/kg|3+3 design was employed for the first dosing cycle at each dose level. The 7 dose levels were 0.0003 mg/kg, 0.003 mg/kg, 0.015 mg/kg, 0.075 mg/kg, 0.3 mg/kg, 1.0 mg/kg, and 3.0 mg/kg. The subjects received up to a total of 4 administrations of Anti-KIR (1-7F9) with a dosing interval between each administration of 4 weeks.
1104334|NCT00552344|B1|Baseline|Certolizumab Pegol|Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
1104335|NCT00552344|P1|Participant Flow|Certolizumab Pegol|Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
1104380|NCT00552240|B1|Baseline|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104337|NCT00552344|O1|Outcome|Certolizumab Pegol|Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
1104338|NCT00552344|O1|Outcome|Certolizumab Pegol (Intention-to-Treat)|"Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.~The ITT Population includes all enrolled subjects irrespective of any protocol deviations who received at least 1 open-label injection of study treatment and who had at least 1 efficacy measurement after the first open-label injection."
1104339|NCT00552344|O1|Outcome|Certolizumab Pegol (Intention-to-Treat)|"Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.~The ITT Population includes all enrolled subjects irrespective of any protocol deviations who received at least 1 open-label injection of study treatment and who had at least 1 efficacy measurement after the first open-label injection."
1104340|NCT00552344|O1|Outcome|Certolizumab Pegol|Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
1104341|NCT00552344|O1|Outcome|Certolizumab Pegol|Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
1104342|NCT00552344|E1|Reported Event|Certolizumab Pegol|Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
1104343|NCT00552305|B1|Baseline|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
1104344|NCT00552305|P1|Participant Flow|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
1104345|NCT00552305|O1|Outcome|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
1104346|NCT00552305|O1|Outcome|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
1104347|NCT00552305|O1|Outcome|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
1104348|NCT00552305|O1|Outcome|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
1104349|NCT00552305|O1|Outcome|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
1104350|NCT00552305|E1|Reported Event|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
1104351|NCT00552279|B3|Baseline|Total|Total of all reporting groups
1104352|NCT00552279|B2|Baseline|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1104353|NCT00552279|B1|Baseline|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
1104354|NCT00552279|P2|Participant Flow|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1104355|NCT00552279|P1|Participant Flow|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
1104356|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1104357|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
1104358|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1104359|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
1104360|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1104361|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
1104365|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
1104366|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1104367|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
1104368|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1104369|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
1104370|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1104371|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
1104372|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1104373|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
1104374|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1104375|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
1104376|NCT00552279|E2|Reported Event|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1104377|NCT00552279|E1|Reported Event|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
1104378|NCT00552240|B3|Baseline|Total|Total of all reporting groups
1104379|NCT00552240|B2|Baseline|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104381|NCT00552240|P2|Participant Flow|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104382|NCT00552240|P1|Participant Flow|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104383|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104384|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104385|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104386|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104387|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104388|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104389|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104390|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104391|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104392|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104393|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104394|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104395|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104396|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104397|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104398|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104399|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104400|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104401|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104402|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104403|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104404|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104405|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104406|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104407|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104408|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104409|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104410|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104411|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104412|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104413|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104414|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104415|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104416|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104417|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104418|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104419|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104420|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104421|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104422|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104423|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104424|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104425|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104426|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104427|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104428|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104429|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104430|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104431|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104432|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104433|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104434|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104435|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104436|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104437|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104438|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104439|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104440|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104441|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104442|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104443|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104444|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104445|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104446|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104447|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104448|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104449|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104450|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104451|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104452|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104453|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104454|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104455|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104456|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104457|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104458|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104459|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104460|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104461|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104462|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104463|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104464|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104465|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104466|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104467|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104468|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104469|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104470|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104471|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104472|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104539|NCT00552110|P4|Participant Flow|Oxymetazoline|OXY twice daily
1104473|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104474|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104475|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104476|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104477|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104478|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104479|NCT00552240|E2|Reported Event|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
1104480|NCT00552240|E1|Reported Event|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
1104481|NCT00552188|B3|Baseline|Total|Total of all reporting groups
1104482|NCT00552188|B2|Baseline|Placebo|Matching placebo
1104483|NCT00552188|B1|Baseline|VIA-2291|VIA-2291 100mg
1104484|NCT00552188|P2|Participant Flow|Placebo|Matching placebo
1104485|NCT00552188|P1|Participant Flow|VIA-2291|VIA-2291 100mg
1104486|NCT00552188|O2|Outcome|Placebo|Matching placebo
1104487|NCT00552188|O1|Outcome|VIA-2291|VIA-2291 100mg
1104488|NCT00552188|O2|Outcome|Placebo|Matching placebo
1104489|NCT00552188|O1|Outcome|VIA-2291|VIA-2291 100mg
1104490|NCT00552188|E2|Reported Event|Placebo|Matching placebo
1104491|NCT00552188|E1|Reported Event|VIA-2291|VIA-2291 100mg
1104492|NCT00552175|B4|Baseline|Total|Total of all reporting groups
1104493|NCT00552175|B3|Baseline|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
1104494|NCT00552175|B2|Baseline|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
1104495|NCT00552175|B1|Baseline|Placebo|placebo comparator taken orally every day
1104496|NCT00552175|P3|Participant Flow|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
1104497|NCT00552175|P2|Participant Flow|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
1104500|NCT00552175|O2|Outcome|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
1104501|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
1104502|NCT00552175|O2|Outcome|Duloxetine 40 mg and 60 mg Combined|Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
1104503|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
1104504|NCT00552175|O3|Outcome|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
1104505|NCT00552175|O2|Outcome|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
1104506|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
1104507|NCT00552175|O2|Outcome|Duloxetine 40 mg and 60 mg Combined|Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
1104508|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
1104509|NCT00552175|O3|Outcome|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
1104510|NCT00552175|O2|Outcome|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
1104511|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
1104512|NCT00552175|O2|Outcome|Duloxetine 40 mg and 60 mg Combined|Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
1104513|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
1104514|NCT00552175|O3|Outcome|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
1104515|NCT00552175|O2|Outcome|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
1104516|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
1104517|NCT00552175|O2|Outcome|Duloxetine 40 mg and 60 mg Combined|Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
1104518|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
1104519|NCT00552175|O3|Outcome|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
1104520|NCT00552175|O2|Outcome|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
1104521|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
1104522|NCT00552175|O2|Outcome|Duloxetine 40 mg and 60 mg Combined|Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
1104523|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
1104524|NCT00552175|O3|Outcome|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
1104525|NCT00552175|O2|Outcome|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
1104526|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
1104527|NCT00552175|O2|Outcome|Duloxetine 40 mg and 60 mg Combined|Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
1104528|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
1104529|NCT00552175|E3|Reported Event|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
1104530|NCT00552175|E2|Reported Event|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
1104531|NCT00552175|E1|Reported Event|Placebo|placebo comparator taken orally every day
1104532|NCT00552110|B6|Baseline|Total|Total of all reporting groups
1104533|NCT00552110|B5|Baseline|Placebo|Placebo nasal spray
1104534|NCT00552110|B4|Baseline|Oxymetazoline|OXY twice daily
1104535|NCT00552110|B3|Baseline|Mometasone|MFNS once daily
1104536|NCT00552110|B2|Baseline|Combination3|MFNS with OXY 3 sprays once daily
1104537|NCT00552110|B1|Baseline|Combination1|Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily
1104538|NCT00552110|P5|Participant Flow|Placebo|Placebo nasal spray
1104540|NCT00552110|P3|Participant Flow|Mometasone|MFNS once daily
1104541|NCT00552110|P2|Participant Flow|Combination3|MFNS with OXY 3 sprays once daily
1104542|NCT00552110|P1|Participant Flow|Combination1|Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily
1104543|NCT00552110|O5|Outcome|Placebo|Placebo nasal spray
1104544|NCT00552110|O4|Outcome|Oxymetazoline|OXY twice daily
1104545|NCT00552110|O3|Outcome|Mometasone|MFNS once daily
1104546|NCT00552110|O2|Outcome|Combination3|MFNS with OXY 3 sprays once daily
1104547|NCT00552110|O1|Outcome|Combination1|Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily
1104548|NCT00552110|O5|Outcome|Placebo|Placebo nasal spray
1104549|NCT00552110|O4|Outcome|Oxymetazoline|OXY twice daily
1104550|NCT00552110|O3|Outcome|Mometasone|MFNS once daily
1104551|NCT00552110|O2|Outcome|Combination3|MFNS with OXY 3 sprays once daily
1104552|NCT00552110|O1|Outcome|Combination1|Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily
1104553|NCT00552110|E5|Reported Event|Placebo|Placebo nasal spray
1104554|NCT00552110|E4|Reported Event|Oxymetazoline|OXY twice daily
1104555|NCT00552110|E3|Reported Event|Mometasone|MFNS once daily
1104556|NCT00552110|E2|Reported Event|Combination3|MFNS with OXY 3 sprays once daily
1104557|NCT00552110|E1|Reported Event|Combination1|Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily
1104558|NCT00552084|B3|Baseline|Total|Total of all reporting groups
1104559|NCT00552084|B2|Baseline|Placebo|"corn oil taken daily for 24 weeks~Placebo: Placebo supplements will be taken daily for 24 weeks."
1104560|NCT00552084|B1|Baseline|Fish Oil|"4 grams fish oil daily for 24 weeks~Fish oil: Fish oil supplements 4 gms will be taken daily for 24 weeks."
1104561|NCT00552084|P2|Participant Flow|Placebo|"corn oil taken daily for 24 weeks~Placebo: Placebo supplements will be taken daily for 24 weeks."
1104562|NCT00552084|P1|Participant Flow|Fish Oil|"4 grams fish oil daily for 24 weeks~Fish oil: Fish oil supplements 4 gms will be taken daily for 24 weeks."
1104563|NCT00552084|O2|Outcome|Placebo|"corn oil taken daily for 24 weeks~Placebo: Placebo supplements will be taken daily for 24 weeks."
1104564|NCT00552084|O1|Outcome|Fish Oil|"4 grams fish oil daily for 24 weeks~Fish oil: Fish oil supplements 4 gms will be taken daily for 24 weeks."
1104565|NCT00552084|E2|Reported Event|Placebo|"corn oil taken daily for 24 weeks~Placebo: Placebo supplements will be taken daily for 24 weeks."
1104566|NCT00552084|E1|Reported Event|Fish Oil|"4 grams fish oil daily for 24 weeks~Fish oil: Fish oil supplements 4 gms will be taken daily for 24 weeks."
1104567|NCT00552058|B3|Baseline|Total|Total of all reporting groups
1104568|NCT00552058|B2|Baseline|Placebo|Placebo, saline solution for sc injection
1104569|NCT00552058|B1|Baseline|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
1104570|NCT00552058|P2|Participant Flow|Placebo|Placebo, saline solution for sc injection
1104571|NCT00552058|P1|Participant Flow|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
1104572|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
1104573|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
1104574|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
1104575|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
1104576|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
1104577|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
1104578|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
1104579|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
1104580|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
1104581|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
1104582|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
1104583|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
1104584|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
1104585|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
1104586|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
1104587|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
1104588|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
1104589|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
1104590|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
1104591|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
1104592|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
1104593|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
1104594|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
1104595|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
1104596|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
1104597|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
1104598|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
1104599|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
1104600|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
1104601|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
1104602|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
1104603|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
1104604|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
1104605|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
1104606|NCT00552058|E2|Reported Event|Placebo|Placebo, saline solution for sc injection
1104607|NCT00552058|E1|Reported Event|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
1104608|NCT00552032|B3|Baseline|Total|Total of all reporting groups
1104609|NCT00552032|B2|Baseline|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104610|NCT00552032|B1|Baseline|Mometasone Furoate Nasal Spray|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104611|NCT00552032|P2|Participant Flow|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104612|NCT00552032|P1|Participant Flow|Mometasone Furoate Nasal Spray|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104613|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104614|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104615|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104616|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104617|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104618|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104619|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104620|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104621|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104622|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104623|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104624|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104625|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104626|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104627|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104628|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104629|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104630|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104631|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104632|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104633|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104634|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104635|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104636|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104637|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104638|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104639|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104640|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104641|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104642|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104643|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104644|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104645|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104646|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104647|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104673|NCT00551707|B1|Baseline|CRx-102 (2.7/180)|Crx-102 (Dose 1) 2.7 mg prednisolone plus 180 mg dipyridamole
1104648|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104649|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104650|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104651|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104652|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104653|NCT00552032|E2|Reported Event|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104654|NCT00552032|E1|Reported Event|Mometasone Furoate Nasal Spray|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
1104655|NCT00551759|B1|Baseline|Neoadjuvant Therapy, Surgery, Adjuvant Therapy|"Neoadjuvant chemoradiotherapy and cetuximab: Patients (pts) receive oxaliplatin IV over 2 hours on days 1, 15, and 29, cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, and 5-FU IV over 24 hours on days 1-35. Pts also undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Pts then proceed to surgery.~Surgery: Pts undergo surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab. Pts with an R0 or R1 resection proceed to adjuvant therapy. Pts whose tumors have not been completely resected or who have metastatic disease discontinue protocol therapy and receive further therapy at the discretion of the treating physician.~Adjuvant therapy: Within 4-8 weeks after surgery, pts receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity."
1104656|NCT00551759|P1|Participant Flow|Neoadjuvant Therapy, Surgery, Adjuvant Therapy|"Neoadjuvant chemoradiotherapy and cetuximab: Patients (pts) receive oxaliplatin IV over 2 hours on days 1, 15, and 29, cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, and 5-FU IV over 24 hours on days 1-35. Pts also undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Pts then proceed to surgery.~Surgery: Pts undergo surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab. Pts with an R0 or R1 resection proceed to adjuvant therapy. Pts whose tumors have not been completely resected or who have metastatic disease discontinue protocol therapy and receive further therapy at the discretion of the treating physician.~Adjuvant therapy: Within 4-8 weeks after surgery, pts receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity."
1104718|NCT00551291|P1|Participant Flow|Mycophenolate Mofetil + Prednisone + Erythropoietin Beta|"Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.~Mycophenolate mofetil: 1 gm twice daily orally until end of study.~Prednisone: 10 mg/day orally until end of study.~Erythropoietin Beta: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks."
1104756|NCT00551174|B2|Baseline|3 mg Ibandronate q3mo|3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
1104757|NCT00551174|B1|Baseline|2 mg Ibandronate q2mo|2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
1104657|NCT00551759|O1|Outcome|Neoadjuvant Therapy, Surgery, Adjuvant Therapy|"Neoadjuvant chemoradiotherapy and cetuximab: Patients (pts) receive oxaliplatin IV over 2 hours on days 1, 15, and 29, cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, and 5-FU IV over 24 hours on days 1-35. Pts also undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Pts then proceed to surgery.~Surgery: Pts undergo surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab. Pts with an R0 or R1 resection proceed to adjuvant therapy. Pts whose tumors have not been completely resected or who have metastatic disease discontinue protocol therapy and receive further therapy at the discretion of the treating physician.~Adjuvant therapy: Within 4-8 weeks after surgery, pts receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity."
1104658|NCT00551759|E1|Reported Event|Neoadjuvant Therapy, Surgery, Adjuvant Therapy|35 days of neoadjuvant chemoradiotherapy with oxaliplatin and infusional 5-fluorouracil plus cetuximab followed by post-operative docetaxel and cetuximab.
1104659|NCT00551746|B3|Baseline|Total|Total of all reporting groups
1104660|NCT00551746|B2|Baseline|Grape Juice Placebo|Taste, color, and calorically matched grape juice placebo
1104661|NCT00551746|B1|Baseline|Grape Juice|100% Grape Juice
1104662|NCT00551746|P2|Participant Flow|Grape Juice Placebo|Taste, color, and calorically matched grape juice placebo
1104663|NCT00551746|P1|Participant Flow|Grape Juice|100% Grape Juice
1104664|NCT00551746|O2|Outcome|Placebo|Taste, color, and colorically matched grape juice placebo
1104665|NCT00551746|O1|Outcome|Purple Grape Juice|100% grape juice
1104666|NCT00551746|E2|Reported Event|Grape Juice Placebo|Taste, color, and calorically matched grape juice placebo
1104667|NCT00551746|E1|Reported Event|Grape Juice|100% Grape Juice
1104668|NCT00551707|B6|Baseline|Total|Total of all reporting groups
1104669|NCT00551707|B5|Baseline|Placebo|"placebo~placebo: placebo"
1104670|NCT00551707|B4|Baseline|Dipyridamole|"dipyridamole~dipyridamole: dipyridamole (180 mg or 360 mg)"
1104671|NCT00551707|B3|Baseline|Prednisolone|"prednisolone~prednisolone: prednisolone (2.7 mg)"
1104672|NCT00551707|B2|Baseline|CRx-102 (2.7/360)|"Crx-102 (Dose 2)~2.7 mg prednisolone plus 360 mg dipyridamole"
1104675|NCT00551707|P4|Participant Flow|Dipyridamole|"dipyridamole~dipyridamole: dipyridamole (360 mg)"
1104676|NCT00551707|P3|Participant Flow|Prednisolone|"prednisolone~prednisolone: prednisolone (2.7 mg)"
1104677|NCT00551707|P2|Participant Flow|CRx-102 (2.7/360)|"Crx-102 (Dose 2)~2.7 mg prednisolone plus 360 mg dipyridamole"
1104678|NCT00551707|P1|Participant Flow|CRx-102 (2.7/180)|CRx-102 dose 1 2.7 mg prednisolone plus 180 mg dipyridamole
1104679|NCT00551707|O5|Outcome|Placebo|"placebo~placebo: placebo"
1104680|NCT00551707|O4|Outcome|Dipyridamole|"dipyridamole~dipyridamole: dipyridamole 360 mg"
1104681|NCT00551707|O3|Outcome|Prednisolone|"prednisolone~prednisolone: prednisolone (2.7 mg)"
1104682|NCT00551707|O2|Outcome|CRx-102 (2.7/360)|"Crx-102 (Dose 2)~2.7 mg prednisolone plus 360 mg dipyridamole"
1104683|NCT00551707|O1|Outcome|CRx-102 (2.7/180)|"Crx-102 (Dose 1)~2.7 mg prednisolone plus 180 mg dipyridamole"
1104684|NCT00551707|O5|Outcome|Placebo|"placebo~placebo: placebo"
1104685|NCT00551707|O4|Outcome|Dipyridamole|"dipyridamole~dipyridamole: dipyridamole (360 mg)"
1104686|NCT00551707|O3|Outcome|Prednisolone|"prednisolone~prednisolone: prednisolone (2.7 mg)"
1104687|NCT00551707|O2|Outcome|CRx-102 (2.7/360)|"Crx-102 (Dose 2)~2.7 mg prednisolone plus 360 mg dipyridamole"
1104688|NCT00551707|O1|Outcome|CRx-102 (2.7/180)|CRx-102 dose 1 2.7 mg prednisolone plus 180 mg dipyridamole
1104689|NCT00551707|E5|Reported Event|Placebo|"placebo~placebo: placebo"
1104690|NCT00551707|E4|Reported Event|Dipyridamole|"dipyridamole~dipyridamole: dipyridamole (180 mg or 360 mg)"
1104691|NCT00551707|E3|Reported Event|Prednisolone|"prednisolone~prednisolone: prednisolone (2.7 mg)"
1104692|NCT00551707|E2|Reported Event|CRx-102 (Dose 2)|"Crx-102 (Dose 2)~CRx-102: prednisolone + dipyridamole"
1104693|NCT00551707|E1|Reported Event|CRx-102 (Dose 1)|"Crx-102 (Dose 1)~CRx-102: prednisolone + dipyridamole"
1104694|NCT00551642|B3|Baseline|Total|Total of all reporting groups
1104695|NCT00551642|B2|Baseline|Placebo (Nitrogen)|Placebo Nitrogen gas administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million for a maximum of 21 days
1104696|NCT00551642|B1|Baseline|Inhaled Nitric Oxide (NO)|Inhaled NO administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for a maximum of 21 days
1104697|NCT00551642|P2|Participant Flow|Placebo (Nitrogen)|Placebo Nitrogen gas administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million for a maximum of 21 days
1104698|NCT00551642|P1|Participant Flow|Inhaled Nitric Oxide (NO)|Inhaled NO administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for a maximum of 21 days
1104699|NCT00551642|O2|Outcome|Placebo (Nitrogen)|Placebo Nitrogen gas administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million for a maximum of 21 days
1104700|NCT00551642|O1|Outcome|Inhaled Nitric Oxide (NO)|Inhaled NO administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for a maximum of 21 days
1104701|NCT00551642|E2|Reported Event|Placebo (Nitrogen)|Placebo Nitrogen gas administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million for a maximum of 21 days
1104702|NCT00551642|E1|Reported Event|Inhaled Nitric Oxide (NO)|Inhaled NO administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for a maximum of 21 days
1104703|NCT00551421|B1|Baseline|Pertuzumab and Cetuximab|Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 2, 8, and 15 of course 1 and on days 1, 8, and 15 in all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1104704|NCT00551421|P1|Participant Flow|Pertuzumab and Cetuximab|"Original Protocol, Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1 of each cycle (loading dose cycle 1 only). Patients also receive cetuximab IV over 60-120 minutes on days 2 (loading dose only), 8, and 15 of cycle 1 and on days 1, 8, and 15 in all subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Amended Protocol, Phase I: Same as Original Protocol (see above) without a loading dose of Cetuximab (maintenance dose given on cycle 1, day 2 instead).~Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).~Given IV: irinotecan hydrochloride, pertuzumab, cetuximab~Correlative Studies: laboratory biomarker analysis, gene expression analysis, fluorescence in situ hybridization, mutation analysis, polymerase chain reaction, immunohistochemistry staining method"
1104705|NCT00551421|O1|Outcome|Arm I|"Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 2, 8, and 15 of course 1 and on days 1, 8, and 15 in all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).~pertuzumab: Given IV~cetuximab: Given IV~irinotecan hydrochloride: Given IV~immunohistochemistry staining method: Correlative study~fluorescence in situ hybridization: Correlative study~gene expression analysis: Correlative study~mutation analysis: Correlative study~polymerase chain reaction: Correlative study~laboratory biomarker analysis: Correlative study"
1104706|NCT00551421|O1|Outcome|Arm I|"Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 2, 8, and 15 of course 1 and on days 1, 8, and 15 in all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).~pertuzumab: Given IV~cetuximab: Given IV~irinotecan hydrochloride: Given IV~immunohistochemistry staining method: Correlative study~fluorescence in situ hybridization: Correlative study~gene expression analysis: Correlative study~mutation analysis: Correlative study~polymerase chain reaction: Correlative study~laboratory biomarker analysis: Correlative study"
1104724|NCT00551213|B2|Baseline|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
1104707|NCT00551421|O1|Outcome|Arm I|"Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 2, 8, and 15 of course 1 and on days 1, 8, and 15 in all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).~pertuzumab: Given IV~cetuximab: Given IV~irinotecan hydrochloride: Given IV~immunohistochemistry staining method: Correlative study~fluorescence in situ hybridization: Correlative study~gene expression analysis: Correlative study~mutation analysis: Correlative study~polymerase chain reaction: Correlative study~laboratory biomarker analysis: Correlative study"
1104708|NCT00551421|O1|Outcome|Pertuzumab and Cetuximab|"Original Protocol, Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1 of each cycle (loading dose cycle 1 only). Patients also receive cetuximab IV over 60-120 minutes on days 2 (loading dose only), 8, and 15 of cycle 1 and on days 1, 8, and 15 in all subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Amended Protocol, Phase I: Same as Original Protocol (see above) without a loading dose of Cetuximab (maintenance dose given on cycle 1, day 2 instead).~Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).~Given IV: irinotecan hydrochloride, pertuzumab, cetuximab~Correlative Studies: laboratory biomarker analysis, gene expression analysis, fluorescence in situ hybridization, mutation analysis, polymerase chain reaction, immunohistochemistry staining method"
1104709|NCT00551421|E1|Reported Event|Pertuzumab and Cetuximab|"Original Protocol: Patients received pertuzumab IV over 30-60 minutes on day 1 of each cycle (loading dose on cycle 1, day 1 only). Patients also receive cetuximab IV over 60-120 minutes on days 2 (loading dose), 8, and 15 of cycle 1 and on days 1, 8, and 15 in all subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Amended Protocol, Phase I: Same as the Original Protocol (see above) except the Cetuximab loading dose was no longer given on cycle 1, day 2 (maintainance dose given).~Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).~Given IV: pertuzumab, cetuximab, irinotecan hydrochloride~Corrlateive studies: immunohistochemistry staining method, fluorescence in situ hybridization, gene expression analysis, mutation analysis, polymerase chain reaction, laboratory biomarker analysis"
1104710|NCT00551369|B1|Baseline|SBRT|Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
1104711|NCT00551369|P1|Participant Flow|SBRT|Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
1104712|NCT00551369|O1|Outcome|SBRT|Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
1104713|NCT00551369|O1|Outcome|SBRT|Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
1104714|NCT00551369|O1|Outcome|SBRT|Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
1104715|NCT00551369|O1|Outcome|SBRT|Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
1104716|NCT00551369|E1|Reported Event|SBRT|Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
1104717|NCT00551291|B1|Baseline|Mycophenolate Mofetil + Prednisone + Erythropoietin Beta|"Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.~Mycophenolate mofetil: 1 gm twice daily orally until end of study.~Prednisone: 10 mg/day orally until end of study.~Erythropoietin Beta: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks."
1104736|NCT00551213|O2|Outcome|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
1104719|NCT00551291|O1|Outcome|Mycophenolate Mofetil + Prednisone + Erythropoietin Beta|"Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.~Mycophenolate mofetil: 1 gm twice daily orally until end of study.~Prednisone: 10 mg/day orally until end of study.~Erythropoietin Beta: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks."
1104720|NCT00551291|O1|Outcome|Mycophenolate Mofetil + Prednisone + Erythropoietin Beta|"Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.~Mycophenolate mofetil: 1 gm twice daily orally until end of study.~Prednisone: 10 mg/day orally until end of study.~Erythropoietin Beta: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks."
1104721|NCT00551291|O1|Outcome|Mycophenolate Mofetil + Prednisone + Erythropoietin Beta|"Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.~Mycophenolate mofetil: 1 gm twice daily orally until end of study.~Prednisone: 10 mg/day orally until end of study.~Erythropoietin Beta: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks."
1104722|NCT00551291|E1|Reported Event|Mycophenolate Mofetil + Prednisone + Erythropoietin Beta|"Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.~Mycophenolate mofetil: 1 gm twice daily orally until end of study.~Prednisone: 10 mg/day orally until end of study.~Erythropoietin Beta: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks."
1104723|NCT00551213|B3|Baseline|Total|Total of all reporting groups
1104931|NCT00551031|O5|Outcome|Fluzone® Adults Group|Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
1104725|NCT00551213|B1|Baseline|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
1104726|NCT00551213|P2|Participant Flow|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
1104727|NCT00551213|P1|Participant Flow|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg intravenously (IV) followed by 1 dose of robatumumab 10 mg/kg IV once every 2 weeks (Q2W) until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
1104728|NCT00551213|O2|Outcome|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
1104729|NCT00551213|O1|Outcome|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
1104730|NCT00551213|O2|Outcome|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
1104731|NCT00551213|O1|Outcome|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
1104732|NCT00551213|O2|Outcome|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
1104733|NCT00551213|O1|Outcome|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
1104734|NCT00551213|O2|Outcome|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
1104735|NCT00551213|O1|Outcome|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
1104737|NCT00551213|O1|Outcome|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
1104738|NCT00551213|O2|Outcome|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
1104739|NCT00551213|O1|Outcome|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
1104740|NCT00551213|E2|Reported Event|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
1104741|NCT00551213|E1|Reported Event|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
1104742|NCT00551200|B1|Baseline|Buphenyl to HPN-100|HPN-100 : Subjects will be taking prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects will take prescribed dose of Buphenyl® TID for first week of study, and then switch over to HPN-100 TID during a dose-escalation phase. The dose of HPN-100 will be increased and the dose of Buphenyl® will be decreased each week by 50 mg/kg until entire daily dose of phenylbutyrate is HPN-100. Target HPN-100 dose will contain the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject will take HPN-100 alone for one week and then switch back to previous dose of Buphenyl for the last week of the study.
1104771|NCT00551161|P1|Participant Flow|Memantine|24-week observational lead-in period, wherein patients already on a stable dose of donepezil, rivastigmine, or galantamine continue on that dose, followed by a 24-week open-label memantine period, wherein patients receive open-label memantine treatment titrated to a dose of 20 mg per day, in addition to their ongoing stable cholinesterase inhibitor treatment
1105153|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
1104743|NCT00551200|P1|Participant Flow|Buphenyl to HPN-100|HPN-100 : Subjects took prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects took prescribed dose of Buphenyl® TID for first week of study, and then switched over to HPN-100 TID during a dose-escalation phase. The dose of HPN-100 was increased and the dose of Buphenyl® was decreased each week by 50 mg/kg until entire daily dose of phenylbutyrate was HPN-100. Target HPN-100 dose contained the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject took HPN-100 alone for one week and then switched back to previous dose of Buphenyl for the last week of the study.
1104744|NCT00551200|O2|Outcome|HPN-100|HPN-100 dose contained the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject took HPN-100 alone for one week to reach steady state before blood sample collection.
1104745|NCT00551200|O1|Outcome|Buphenyl|Subjects took prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects took prescribed dose of Buphenyl® TID for first week of study before blood sample collection.
1104746|NCT00551200|O2|Outcome|HPN-100|HPN-100 dose contained the same amount of phenylbutyrates as the subject's prescribed daily dose of Buphenyl®. Subject took HPN-100 alone for one week to reach steady state before blood sample collection.
1104747|NCT00551200|O1|Outcome|Buphenyl|Subjects took prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects took prescribed dose of Buphenyl® TID for first week of study before blood sample collection.
1104748|NCT00551200|O1|Outcome|Buphenyl to HPN-100|HPN-100 : Subjects will be taking prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects will take prescribed dose of Buphenyl® TID for first week of study, and then switch over to HPN-100 TID during a dose-escalation phase. The dose of HPN-100 will be increased and the dose of Buphenyl® will be decreased each week by 50 mg/kg until entire daily dose of phenylbutyrate is HPN-100. Target HPN-100 dose will contain the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject will take HPN-100 alone for one week and then switch back to previous dose of Buphenyl for the last week of the study.
1104749|NCT00551200|O2|Outcome|HPN-100 Steady State|After dose escalation to full dose of HPN-100 was completed, subjects received only HPN-100 for 1 week (and achieved steady state) prior to switching back to their original NaPBA treatment.
1104750|NCT00551200|O1|Outcome|NaPBA Steady State|Subjects were on NaPBA TID treatment for at least 2 weeks prior to enrollment, and were thus expected to be at steady-state levels prior to enrollment. After enrollment, subjects received 1 week of NaPBA treatment before switching over to HPN-100 dose escalation phase.
1104751|NCT00551200|O2|Outcome|HPN-100 Steady State|After dose escalation to full dose of HPN-100 was completed, subjects received only HPN-100 for 1 week (and achieved steady state) prior to switching back to their original NaPBA treatment.
1104752|NCT00551200|O1|Outcome|NaPBA Steady State|Subjects were on NaPBA TID treatment for at least 2 weeks prior to enrollment, and were thus expected to be at steady-state levels prior to enrollment. After enrollment, subjects received 1 week of NaPBA treatment before switching over to HPN-100 dose escalation phase.
1104753|NCT00551200|E2|Reported Event|HPN-100|HPN-100 : Subjects will be taking prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects will take prescribed dose of Buphenyl® TID for first week of study, and then switch over to HPN-100 TID during a dose-escalation phase. The dose of HPN-100 will be increased and the dose of Buphenyl® will be decreased each week by 50 mg/kg until entire daily dose of phenylbutyrate is HPN-100. Target HPN-100 dose will contain the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject will take HPN-100 alone for one week and then switch back to previous dose of Buphenyl for the last week of the study.
1104754|NCT00551200|E1|Reported Event|Buphenyl|HPN-100 : Subjects will be taking prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects will take prescribed dose of Buphenyl® TID for first week of study, and then switch over to HPN-100 TID during a dose-escalation phase. The dose of HPN-100 will be increased and the dose of Buphenyl® will be decreased each week by 50 mg/kg until entire daily dose of phenylbutyrate is HPN-100. Target HPN-100 dose will contain the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject will take HPN-100 alone for one week and then switch back to previous dose of Buphenyl for the last week of the study.
1104755|NCT00551174|B3|Baseline|Total|Total of all reporting groups
1105120|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
1104758|NCT00551174|P2|Participant Flow|3 mg Ibandronate q3mo|3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
1104759|NCT00551174|P1|Participant Flow|2 mg Ibandronate q2mo|2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
1104760|NCT00551174|O2|Outcome|3 mg Ibandronate q3mo|3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
1104761|NCT00551174|O1|Outcome|2 mg Ibandronate q2mo|2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
1104762|NCT00551174|O2|Outcome|3 mg Ibandronate q3mo|3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
1104763|NCT00551174|O1|Outcome|2 mg Ibandronate q2mo|2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
1104764|NCT00551174|O2|Outcome|3 mg Ibandronate q3mo|3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
1104765|NCT00551174|O1|Outcome|2 mg Ibandronate q2mo|2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
1104766|NCT00551174|O2|Outcome|3 mg Ibandronate q3mo|3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
1104767|NCT00551174|O1|Outcome|2 mg Ibandronate q2mo|2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
1104768|NCT00551174|E2|Reported Event|3 mg Ibandronate q3mo|3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
1104769|NCT00551174|E1|Reported Event|2 mg Ibandronate q2mo|2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
1104770|NCT00551161|B1|Baseline|Single-arm|24-week observational lead-in period, wherein patients already on a stable dose of donepezil, rivastigmine, or galantamine continue on that dose, followed by a 24-week open-label memantine period, wherein patients receive open-label memantine treatment titrated to a dose of 20 mg per day, in addition to their ongoing stable cholinesterase inhibitor treatment
1104930|NCT00551031|O1|Outcome|Influenza Virus Vaccine Formulation 1|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
1104772|NCT00551161|O1|Outcome|Memantine|24-week observational lead-in period, wherein patients already on a stable dose of donepezil, rivastigmine, or galantamine continue on that dose, followed by a 24-week open-label memantine period, wherein patients receive open-label memantine treatment titrated to a dose of 20 mg per day, in addition to their ongoing stable cholinesterase inhibitor treatment
1104773|NCT00551161|E1|Reported Event|Single-arm|24-week observational lead-in period, wherein patients already on a stable dose of donepezil, rivastigmine, or galantamine continue on that dose, followed by a 24-week open-label memantine period, wherein patients receive open-label memantine treatment titrated to a dose of 20 mg per day, in addition to their ongoing stable cholinesterase inhibitor treatment
1104774|NCT00551135|B5|Baseline|Total|Total of all reporting groups
1104775|NCT00551135|B4|Baseline|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
1104776|NCT00551135|B3|Baseline|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
1104777|NCT00551135|B2|Baseline|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
1104778|NCT00551135|B1|Baseline|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
1104779|NCT00551135|P4|Participant Flow|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
1104780|NCT00551135|P3|Participant Flow|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
1104781|NCT00551135|P2|Participant Flow|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
1104782|NCT00551135|P1|Participant Flow|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
1104783|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
1104784|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
1104785|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
1104786|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
1104787|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
1104788|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
1104789|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
1104790|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
1104791|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
1104792|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
1104793|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
1104794|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
1104795|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
1104796|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
1104797|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
1104798|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
1104799|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
1104800|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
1104801|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
1104802|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
1104803|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
1104804|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
1104805|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
1104806|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
1104807|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
1104808|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
1104809|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
1104810|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
1104811|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
1104812|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
1104813|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
1104814|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
1104815|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
1104816|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
1104817|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
1104818|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
1104819|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
1104820|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
1104821|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
1104822|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
1104823|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
1104824|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
1104825|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
1104826|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
1104827|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
1104828|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
1104829|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
1104830|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
1104831|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
1104832|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
1104833|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
1104834|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
1104835|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
1104836|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
1104837|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
1104838|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
1104839|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
1104840|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
1104841|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
1104842|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
1104843|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
1104844|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
1104845|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
1104846|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
1104847|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
1104848|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
1104849|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
1104850|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
1104851|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
1104852|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
1104853|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
1104854|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
1104855|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
1104856|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
1104857|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
1104858|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
1104859|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
1104860|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
1104861|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
1104862|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
1104863|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
1104864|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
1104865|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
1104866|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
1104867|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
1104868|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
1104869|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
1104870|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
1104871|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
1104872|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
1104873|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
1104874|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
1104875|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
1104876|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
1104877|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
1104878|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
1104879|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
1104880|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
1104881|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
1104882|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
1104883|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
1104884|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
1104885|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
1104886|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
1104887|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
1104888|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
1104889|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
1104890|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
1104891|NCT00551135|E4|Reported Event|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
1104892|NCT00551135|E3|Reported Event|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
1104893|NCT00551135|E2|Reported Event|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
1104894|NCT00551135|E1|Reported Event|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
1104895|NCT00551070|B1|Baseline|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
1104896|NCT00551070|P1|Participant Flow|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
1104897|NCT00551070|O1|Outcome|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
1104898|NCT00551070|O1|Outcome|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
1104899|NCT00551070|O1|Outcome|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
1104900|NCT00551070|O1|Outcome|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
1104901|NCT00551070|O1|Outcome|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
1104902|NCT00551070|O1|Outcome|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
1104903|NCT00551070|O1|Outcome|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
1104904|NCT00551070|E1|Reported Event|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
1104905|NCT00551031|B6|Baseline|Total|Total of all reporting groups
1104906|NCT00551031|B5|Baseline|Fluzone® Adults Group|Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
1104907|NCT00551031|B4|Baseline|Fluzone® High Dose Group|Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
1104908|NCT00551031|B3|Baseline|Fluzone® Elderly Group|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
1104909|NCT00551031|B2|Baseline|Influenza Virus Vaccine Formulation 2|Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
1104910|NCT00551031|B1|Baseline|Influenza Virus Vaccine Formulation 1|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
1104911|NCT00551031|P5|Participant Flow|Fluzone® Adults Group|Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
1104912|NCT00551031|P4|Participant Flow|Fluzone® High Dose Group|Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
1104913|NCT00551031|P3|Participant Flow|Fluzone® Elderly Group|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
1104914|NCT00551031|P2|Participant Flow|Influenza Virus Vaccine Formulation 2|Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
1104915|NCT00551031|P1|Participant Flow|Influenza Virus Vaccine Formulation 1|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
1104916|NCT00551031|O5|Outcome|Fluzone® Adults Group|Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
1104917|NCT00551031|O4|Outcome|Fluzone® High Dose Group|Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
1104918|NCT00551031|O3|Outcome|Fluzone® Elderly Group|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
1104919|NCT00551031|O2|Outcome|Influenza Virus Vaccine Formulation 2|Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
1104920|NCT00551031|O1|Outcome|Influenza Virus Vaccine Formulation 1|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
1104921|NCT00551031|O5|Outcome|Fluzone® Adults Group|Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
1104922|NCT00551031|O4|Outcome|Fluzone® High Dose Group|Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
1104923|NCT00551031|O3|Outcome|Fluzone® Elderly Group|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
1104924|NCT00551031|O2|Outcome|Influenza Virus Vaccine Formulation 2|Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
1104925|NCT00551031|O1|Outcome|Influenza Virus Vaccine Formulation 1|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
1104926|NCT00551031|O5|Outcome|Fluzone® Adults Group|Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
1104927|NCT00551031|O4|Outcome|Fluzone® High Dose Group|Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
1104928|NCT00551031|O3|Outcome|Fluzone® Elderly Group|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
1104929|NCT00551031|O2|Outcome|Influenza Virus Vaccine Formulation 2|Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
1105154|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
1104932|NCT00551031|O4|Outcome|Fluzone® High Dose Group|Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
1104933|NCT00551031|O3|Outcome|Fluzone® Elderly Group|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
1104934|NCT00551031|O2|Outcome|Influenza Virus Vaccine Formulation 2|Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
1104935|NCT00551031|O1|Outcome|Influenza Virus Vaccine Formulation 1|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
1104936|NCT00551031|E5|Reported Event|Fluzone® Adults Group|Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
1104937|NCT00551031|E4|Reported Event|Fluzone® High Dose Group|Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
1104938|NCT00551031|E3|Reported Event|Fluzone® Elderly Group|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
1104939|NCT00551031|E2|Reported Event|Influenza Virus Vaccine Formulation 2|Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
1104940|NCT00551031|E1|Reported Event|Influenza Virus Vaccine Formulation 1|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
1104941|NCT00550953|B3|Baseline|Total|Total of all reporting groups
1104942|NCT00550953|B2|Baseline|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
1104943|NCT00550953|B1|Baseline|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
1104944|NCT00550953|P2|Participant Flow|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
1104945|NCT00550953|P1|Participant Flow|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
1104946|NCT00550953|O2|Outcome|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
1104947|NCT00550953|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
1104948|NCT00550953|O2|Outcome|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
1104949|NCT00550953|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
1104950|NCT00550953|O2|Outcome|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
1104951|NCT00550953|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
1104952|NCT00550953|O2|Outcome|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
1104953|NCT00550953|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
1104954|NCT00550953|O2|Outcome|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
1104955|NCT00550953|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
1104956|NCT00550953|O2|Outcome|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
1104957|NCT00550953|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
1104958|NCT00550953|O2|Outcome|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
1104959|NCT00550953|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
1104960|NCT00550953|O2|Outcome|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
1104961|NCT00550953|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
1108639|NCT00542425|O5|Outcome|Teriparatide|
1104962|NCT00550953|E2|Reported Event|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
1104963|NCT00550953|E1|Reported Event|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
1104964|NCT00550862|B5|Baseline|Total|Total of all reporting groups
1104965|NCT00550862|B4|Baseline|Placebo|
1104966|NCT00550862|B3|Baseline|INT-747 50 mg|
1104967|NCT00550862|B2|Baseline|INT-747 25 mg|
1104968|NCT00550862|B1|Baseline|INT-747 10 mg|
1104969|NCT00550862|P4|Participant Flow|Placebo|
1104970|NCT00550862|P3|Participant Flow|INT-747 50 mg|
1104971|NCT00550862|P2|Participant Flow|INT-747 25 mg|
1104972|NCT00550862|P1|Participant Flow|INT-747 10 mg|
1104973|NCT00550862|O4|Outcome|Placebo|
1104974|NCT00550862|O3|Outcome|INT-747 50 mg|
1104975|NCT00550862|O2|Outcome|INT-747 25 mg|
1104976|NCT00550862|O1|Outcome|INT-747 10 mg|
1104977|NCT00550862|O4|Outcome|Placebo|
1104978|NCT00550862|O3|Outcome|INT-747 50 mg|
1104979|NCT00550862|O2|Outcome|INT-747 25 mg|
1104980|NCT00550862|O1|Outcome|INT-747 10 mg|
1104981|NCT00550862|O4|Outcome|Placebo|
1104982|NCT00550862|O3|Outcome|INT-747 50 mg|
1104983|NCT00550862|O2|Outcome|INT-747 25 mg|
1104984|NCT00550862|O1|Outcome|INT-747 10 mg|
1104985|NCT00550862|E4|Reported Event|Placebo|
1104986|NCT00550862|E3|Reported Event|INT-747 50 mg|
1104987|NCT00550862|E2|Reported Event|INT-747 25 mg|
1104988|NCT00550862|E1|Reported Event|INT-747 10 mg|
1104989|NCT00550836|B3|Baseline|Total|Total of all reporting groups
1104990|NCT00550836|B2|Baseline|Arm B: PGE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
1104991|NCT00550836|B1|Baseline|Arm A: GE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
1104992|NCT00550836|P2|Participant Flow|Arm B: PGE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
1104993|NCT00550836|P1|Participant Flow|Arm A: GE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
1104994|NCT00550836|O2|Outcome|Arm B: PGE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
1104995|NCT00550836|O1|Outcome|Arm A: GE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
1104996|NCT00550836|O2|Outcome|Arm B: PGE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
1104997|NCT00550836|O1|Outcome|Arm A: GE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
1105121|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
1104998|NCT00550836|O2|Outcome|Arm B: PGE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
1104999|NCT00550836|O1|Outcome|Arm A: GE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
1105000|NCT00550836|O2|Outcome|Arm B: PGE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
1105001|NCT00550836|O1|Outcome|Arm A: GE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
1105081|NCT00550550|O1|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
1106934|NCT00546871|O2|Outcome|Study Part 2, SC Administration|
1105002|NCT00550836|O2|Outcome|Arm B: PGE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
1105003|NCT00550836|O1|Outcome|Arm A: GE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
1105004|NCT00550836|E2|Reported Event|Arm B: PGE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
1105005|NCT00550836|E1|Reported Event|Arm A: GE|Patients receive 1000 mg/m^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
1105006|NCT00550771|B3|Baseline|Total|Total of all reporting groups
1105007|NCT00550771|B2|Baseline|Doxorubicin Based Regimen|doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
1105008|NCT00550771|B1|Baseline|Pegylated Liposomal Doxorubicin (PLD) Based Regimen|PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
1105009|NCT00550771|P2|Participant Flow|Doxorubicin Based Regimen|doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
1105010|NCT00550771|P1|Participant Flow|Pegylated Liposomal Doxorubicin (PLD) Based Regimen|PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
1105011|NCT00550771|O2|Outcome|Doxorubicin Based Regimen|doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
1105122|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
1105012|NCT00550771|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD) Based Regimen|PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
1105013|NCT00550771|O2|Outcome|Doxorubicin Based Regimen|doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
1105014|NCT00550771|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD) Based Regimen|PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
1105015|NCT00550771|O2|Outcome|Doxorubicin Based Regimen|doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
1105016|NCT00550771|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD) Based Regimen|PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
1105017|NCT00550771|O2|Outcome|Doxorubicin Based Regimen|doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
1105082|NCT00550550|O2|Outcome|Placebo|Rapidly dissolving matching placebo tablet administered sublingually once daily.
1105018|NCT00550771|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD) Based Regimen|PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
1105019|NCT00550771|E2|Reported Event|Doxorubicin Based Regimen|
1105020|NCT00550771|E1|Reported Event|PLD Based Regimen|
1105021|NCT00550745|B3|Baseline|Total|Total of all reporting groups
1105022|NCT00550745|B2|Baseline|Placebo|"Represents the number of subjects according to the treatment (placebo) received.~Excludes subjects who were not vaccinated."
1105023|NCT00550745|B1|Baseline|ZOSTAVAX™|"Represents the number of subjects according to the treatment (ZOSTAVAX™) received.~Excludes subjects who were not vaccinated."
1105024|NCT00550745|P2|Participant Flow|Placebo|Represents the number of randomized subjects according to the vaccination group as they were assigned at study entry and not the treatment, ZOSTAVAX™ or placebo, received.
1105025|NCT00550745|P1|Participant Flow|ZOSTAVAX™|Represents the number of randomized subjects according to the vaccination group as they were assigned at study entry and not the treatment, ZOSTAVAX™ or placebo, received.
1105026|NCT00550745|O2|Outcome|Placebo|All subjects who were vaccinated according to actual treatment received (Placebo) and had safety follow-up.
1105027|NCT00550745|O1|Outcome|ZOSTAVAX™|All subjects who were vaccinated according to actual treatment received (ZOSTAVAX™) and had safety follow-up.
1105028|NCT00550745|O2|Outcome|Placebo|All subjects who were vaccinated according to actual treatment received (Placebo) and had safety follow-up.
1105029|NCT00550745|O1|Outcome|ZOSTAVAX™|All subjects who were vaccinated according to actual treatment received (ZOSTAVAX™) and had safety follow-up.
1105030|NCT00550745|E2|Reported Event|Placebo|All subjects who were vaccinated according to actual treatment received (Placebo) and had safety follow-up.
1105031|NCT00550745|E1|Reported Event|ZOSTAVAX™|All subjects who were vaccinated according to actual treatment received (Zostavax™) and had safety follow-up.
1105032|NCT00550732|B1|Baseline|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
1105033|NCT00550732|P1|Participant Flow|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
1105034|NCT00550732|O1|Outcome|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
1105035|NCT00550732|O1|Outcome|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
1105036|NCT00550732|O1|Outcome|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
1105037|NCT00550732|O1|Outcome|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
1105038|NCT00550732|O1|Outcome|Prosaconazole|Posaconazole oral suspension was administered as 400 mg BID with food or 200 mg QID without food for a minimum of one month.
1105039|NCT00550732|O1|Outcome|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
1105040|NCT00550732|O1|Outcome|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
1105041|NCT00550732|O1|Outcome|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
1105123|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
1105124|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
1105042|NCT00550732|E1|Reported Event|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
1105043|NCT00550680|B1|Baseline|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
1105044|NCT00550680|P1|Participant Flow|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with erythropoiesis-stimulating agent (ESA) therapy received intravenous methoxy polyethylene glycol-epoetin beta (Mircera), also known as continuous erythropoietin receptor activator (CERA), every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 micrograms (mcg) was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain hemoglobin (Hb) concentrations within target of 10.5 and 12.5 grams per deciliter (g/dL).
1105045|NCT00550680|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
1105046|NCT00550680|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
1105083|NCT00550550|O1|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
1105047|NCT00550680|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
1105048|NCT00550680|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
1105049|NCT00550680|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
1105050|NCT00550680|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
1105051|NCT00550680|E1|Reported Event|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
1105052|NCT00550654|B1|Baseline|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
1105053|NCT00550654|P1|Participant Flow|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
1105054|NCT00550654|O1|Outcome|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
1105055|NCT00550654|O1|Outcome|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
1105056|NCT00550654|O1|Outcome|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
1105057|NCT00550654|O1|Outcome|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
1105058|NCT00550654|O1|Outcome|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
1105059|NCT00550654|O1|Outcome|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
1105060|NCT00550654|O1|Outcome|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
1105061|NCT00550654|E1|Reported Event|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
1105062|NCT00550589|B1|Baseline|Cidofovir|1.0% topical cidofovir cream
1105063|NCT00550589|P1|Participant Flow|Cidofovir|1.0% topical cidofovir cream
1105064|NCT00550589|O1|Outcome|Cidofovir|1.0% topical cidofovir cream
1105065|NCT00550589|O1|Outcome|Cidofovir|1.0% topical cidofovir cream
1105066|NCT00550589|O1|Outcome|Cidofovir|1.0% topical cidofovir cream
1105067|NCT00550589|O1|Outcome|Cidofovir|1.0% topical cidofovir cream
1105068|NCT00550589|O1|Outcome|Cidofovir|"1.0% topical cidofovir cream~cidofovir: 1.0% topical cream self-applied once daily for 5 consecutive days, with no treatment for the remaining 9 days (a treatment cycle). Subjects will receive up to 6 cycles of treatment.~DNA methylation analysis: formalin fixed biopsy collected at baseline and 6 weeks after treatment discontinuation~gene expression analysis: punch biopsy collected at baseline, after cycle 1, and 6 weeks after treatment discontinuation~polymerase chain reaction: performed on punch biopsy specimens collected at baseline, after cycle 1, and 6 weeks after treatment discontinuation~biopsy: punch biopsy collected at baseline, after cycle 1, and 6 weeks after treatment discontinuation~histopathologic examination: Evaluated at baseline and 6 weeks after treatment discontinuation"
1105069|NCT00550589|O1|Outcome|Cidofovir|1.0% topical cidofovir cream
1105070|NCT00550589|O1|Outcome|Cidofovir|1% cidofovir
1105071|NCT00550589|O1|Outcome|Cidofovir|1.0% topical cidofovir cream
1105072|NCT00550589|E1|Reported Event|Cidofovir|1.0% topical cidofovir cream
1105073|NCT00550550|B3|Baseline|Total|Total of all reporting groups
1105074|NCT00550550|B2|Baseline|Placebo|Matching placebo tablet administered sublingually once daily.
1105075|NCT00550550|B1|Baseline|SCH 697243|SCH 697243 (Phleum pratense extract) administered sublingually once daily.
1105076|NCT00550550|P2|Participant Flow|Placebo|Matching placebo tablet administered sublingually once daily.
1105077|NCT00550550|P1|Participant Flow|SCH 697243|SCH 697243 (Phleum pratense extract) administered sublingually once daily.
1105078|NCT00550550|O2|Outcome|Placebo|Rapidly dissolving matching placebo tablet administered sublingually once daily.
1105079|NCT00550550|O1|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
1105080|NCT00550550|O2|Outcome|Placebo|Rapidly dissolving matching placebo tablet administered sublingually once daily.
1106935|NCT00546871|O1|Outcome|Study Part 1, IV Administration|
1105084|NCT00550550|O2|Outcome|Placebo|Rapidly dissolving matching placebo tablet administered sublingually once daily.
1105085|NCT00550550|O1|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
1105086|NCT00550550|E2|Reported Event|Placebo|Rapidly dissolving matching placebo tablet administered sublingually once daily.
1105087|NCT00550550|E1|Reported Event|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
1105088|NCT00550537|B1|Baseline|Treatment|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
1105089|NCT00550537|P1|Participant Flow|Treatment|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
1105090|NCT00550537|O3|Outcome|Erlotinib|"Erlotinib followed by paclitaxel + carboplatin (PC) or paclitaxel + carboplatin + bevacizumab (PC+B) in non-squamous cell at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
1105091|NCT00550537|O2|Outcome|Erlotinib Followed by PC+B|"Erlotinib followed by paclitaxel + carboplatin (PC) or paclitaxel + carboplatin + bevacizumab (PC+B) in non-squamous cell at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
1105092|NCT00550537|O1|Outcome|Erlotinib Followed by PC|"Erlotinib followed by paclitaxel + carboplatin (PC) or paclitaxel + carboplatin + bevacizumab (PC+B) in non-squamous cell at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
1105093|NCT00550537|O1|Outcome|Erlotinib Segament|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
1105125|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
1105126|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
1105127|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
1105128|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
1105094|NCT00550537|O1|Outcome|Patients on Erlotinib Segament|"Erlotinib followed by paclitaxel + carboplatin (PC) or paclitaxel + carboplatin + bevacizumab (PC+B) in non-squamous cell at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
1105095|NCT00550537|O1|Outcome|Patients on Erlotinib Segament|"Erlotinib followed by paclitaxel + carboplatin (PC) or paclitaxel + carboplatin + bevacizumab (PC+B) in non-squamous cell at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
1105096|NCT00550537|O1|Outcome|Treatment|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
1105097|NCT00550537|O1|Outcome|Treatment|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
1105152|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
1105098|NCT00550537|O1|Outcome|Treatment|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
1105099|NCT00550537|O1|Outcome|Treatment|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
1105100|NCT00550537|O1|Outcome|Treatment|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
1105101|NCT00550537|O1|Outcome|Treatment|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
1105102|NCT00550537|E1|Reported Event|Treatment|"Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.~bevacizumab: 15 mg/m2 given through a vein for every 3 weeks~carboplatin: AUC = 6 given through a vein on day 1 of each cycle.~erlotinib hydrochloride: 150 mg taken by mouth daily~paclitaxel: 200 mg/m2 given through a vein on day 1 of each cycle.~gene expression analysis: Blood and tissue collection.~protein expression analysis: Blood and tissue collection.~proteomic profiling: Blood and tissue collection.~laboratory biomarker analysis: Blood and tissue collection."
1105103|NCT00550459|B3|Baseline|Total|Total of all reporting groups
1105104|NCT00550459|B2|Baseline|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
1105105|NCT00550459|B1|Baseline|Placebo|Placebo tablet given once daily for 21 days
1105106|NCT00550459|P2|Participant Flow|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
1105107|NCT00550459|P1|Participant Flow|Placebo|Placebo tablet given once daily for 21 days
1105108|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
1105109|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
1105110|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
1105111|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
1105112|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
1105113|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
1105114|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
1105115|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
1105116|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
1105117|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
1105118|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
1105119|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
1105129|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
1105130|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
1105131|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
1105132|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
1105133|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
1105134|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
1105135|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
1105136|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
1105137|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
1105138|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
1105139|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
1105140|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
1105141|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
1105142|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
1105143|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
1105144|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
1105145|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
1105146|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
1105147|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
1105148|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
1105149|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
1105150|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
1105151|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
1105155|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
1105156|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
1105157|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
1105158|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
1105159|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
1105160|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
1105161|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
1105162|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
1105163|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
1105164|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
1105165|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
1105166|NCT00550459|E2|Reported Event|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
1105167|NCT00550459|E1|Reported Event|Placebo|Placebo tablet given once daily for 21 days
1105168|NCT00550446|B8|Baseline|Total|Total of all reporting groups
1105169|NCT00550446|B7|Baseline|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105170|NCT00550446|B6|Baseline|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105171|NCT00550446|B5|Baseline|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105172|NCT00550446|B4|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105173|NCT00550446|B3|Baseline|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105174|NCT00550446|B2|Baseline|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105175|NCT00550446|B1|Baseline|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105176|NCT00550446|P11|Participant Flow|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105177|NCT00550446|P10|Participant Flow|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105178|NCT00550446|P9|Participant Flow|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105179|NCT00550446|P8|Participant Flow|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105180|NCT00550446|P7|Participant Flow|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105181|NCT00550446|P6|Participant Flow|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105182|NCT00550446|P5|Participant Flow|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105183|NCT00550446|P4|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105184|NCT00550446|P3|Participant Flow|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105185|NCT00550446|P2|Participant Flow|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105186|NCT00550446|P1|Participant Flow|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105187|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1106116|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
1105188|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105189|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105190|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105191|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105192|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105193|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105194|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105195|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105196|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105197|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105198|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105199|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105200|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105201|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105202|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105203|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105204|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105205|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105206|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105207|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105208|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105209|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105210|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105211|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105212|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105213|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105214|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105215|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105216|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105217|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105218|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105219|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105220|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105221|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105222|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105223|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105224|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105225|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105226|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105227|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105228|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1108640|NCT00542425|O4|Outcome|BA058 80 µg|
1105229|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105230|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105231|NCT00550446|O10|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105232|NCT00550446|O9|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105233|NCT00550446|O8|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105234|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105235|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105236|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105237|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105286|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105238|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105239|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105240|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105241|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105242|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105243|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105244|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105245|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105246|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105247|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105248|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105249|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105250|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105251|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105252|NCT00550446|O10|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105278|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105817|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
1105253|NCT00550446|O9|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105254|NCT00550446|O8|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105255|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105256|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105257|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105258|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105259|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105260|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105312|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105261|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105262|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105263|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105264|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105265|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105266|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105267|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105268|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105269|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105270|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105271|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105272|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105273|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105274|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105275|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105276|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105277|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1108641|NCT00542425|O3|Outcome|BA058 40 µg|
1105279|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105280|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105281|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105282|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105283|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105284|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105285|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105287|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105288|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105289|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105290|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105291|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105292|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105293|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105294|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105295|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105296|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105297|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105298|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105299|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105300|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105301|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105302|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105303|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1108642|NCT00542425|O2|Outcome|BA058 20 µg|
1105304|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105305|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105306|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105307|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105308|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105309|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105310|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105311|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105765|NCT00550147|O2|Outcome|Visit 5 - MPH Monotherapy - Week 4|Score following treatment with MPH monotherapy after Week 4
1105313|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105314|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105315|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105316|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105317|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105318|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105319|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105320|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105321|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105322|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105323|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105324|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105325|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105326|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105327|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105328|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1108643|NCT00542425|O1|Outcome|Placebo|
1105329|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105330|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105331|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105332|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105333|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105334|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105335|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105336|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105337|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105338|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105339|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105340|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105341|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105342|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105343|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105344|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105345|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105346|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105347|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105348|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105349|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105350|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105351|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105352|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105353|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105354|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105355|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105356|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105357|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105358|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105359|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105360|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105361|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105386|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105362|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105363|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105364|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105365|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105366|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105367|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105368|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105369|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105370|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105371|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105372|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105373|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105374|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105375|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105376|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105377|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105378|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105379|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105380|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105381|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105382|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105383|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105384|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105385|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.Participants who administered Adalimumab initially were switched to CP-690,550 5 milligram (mg) tablet from Week 12 to Week 24.
1105766|NCT00550147|O1|Outcome|Baseline|Baseline scores at study entry
1106117|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
1105387|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105388|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105389|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105390|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105391|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105392|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105393|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105394|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105395|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105396|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105397|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105398|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105399|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105400|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105401|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105402|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105403|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105818|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
1105819|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
1105404|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105405|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105406|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105407|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105408|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105409|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105410|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105411|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1106161|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
1105412|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105413|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105414|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105415|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105416|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105417|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105418|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105419|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105420|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105421|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105422|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105423|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105424|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105425|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105426|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105427|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105453|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1108644|NCT00542425|E5|Reported Event|Teriparatide|
1105428|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105429|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105430|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105431|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105432|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105433|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105434|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105435|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105436|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105437|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105438|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105439|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105440|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105441|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105442|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105443|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105444|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105445|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105446|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105447|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105448|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105449|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105450|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105451|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105452|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105454|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105455|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105456|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105457|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105458|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105459|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105460|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105485|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105461|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105462|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105463|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105464|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105465|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105466|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105467|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105468|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105469|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105470|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105471|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105472|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105473|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105474|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105475|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105476|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105477|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105478|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105552|NCT00550446|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105479|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105480|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105481|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105482|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105483|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105484|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1106936|NCT00546871|O6|Outcome|Total SC (Parts 2, 3a, 3b, Extension)|
1105486|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105487|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105488|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105489|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105490|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105491|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105492|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105493|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105494|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105495|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105496|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105497|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105498|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105499|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105500|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105501|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105502|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105577|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105503|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105504|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105505|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105506|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105507|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105508|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105509|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.CP-690,550 10 mg tablet orally twice daily plus placebo QOW subcutaneous injections during Week 0 to Week 10.
1105510|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105511|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.Initially CP-690,550 3 mg tablet administered orally twice daily plus placebo QOW subcutaneous injections during Week 0 to Week 10. After Week 12, participants were reassigned CP-690,550 5 mg tablet administered orally twice daily.
1105512|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105513|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105514|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105515|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105516|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105517|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105518|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105519|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105520|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105521|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105522|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105523|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105524|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105525|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105526|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105527|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105528|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105529|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105530|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105531|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105532|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105533|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105534|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1106937|NCT00546871|O5|Outcome|Study Extension, SC Administration|
1105535|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105536|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105537|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105538|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105539|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105540|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105541|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105542|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105543|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.CP-690,550 5 mg tablet orally twice daily plus placebo QOW subcutaneous injections during Week 0 to Week 10.
1105544|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105545|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105546|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105547|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105548|NCT00550446|O7|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105549|NCT00550446|O6|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105550|NCT00550446|O5|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105551|NCT00550446|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105553|NCT00550446|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105554|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105555|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105556|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105557|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105558|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105559|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105560|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105561|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105562|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105563|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105564|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105565|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105566|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105567|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105568|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105569|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105570|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.CP-690,550 15 mg tablet orally twice daily plus placebo QOW subcutaneous injections during Week 0 to Week 10.
1105571|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105572|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105573|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105574|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105575|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105576|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105578|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105579|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105580|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105581|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105582|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105583|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105584|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105585|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105586|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105587|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105588|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105589|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105590|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105591|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105592|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105593|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105594|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105595|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105596|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105597|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105598|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105599|NCT00550446|O7|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105600|NCT00550446|O6|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105601|NCT00550446|O5|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105602|NCT00550446|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1108645|NCT00542425|E4|Reported Event|BA058 80 µg|
1105603|NCT00550446|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105604|NCT00550446|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105605|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105606|NCT00550446|E11|Reported Event|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105607|NCT00550446|E10|Reported Event|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
1105608|NCT00550446|E9|Reported Event|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in Adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105609|NCT00550446|E8|Reported Event|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105610|NCT00550446|E7|Reported Event|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105611|NCT00550446|E6|Reported Event|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105612|NCT00550446|E5|Reported Event|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
1105613|NCT00550446|E4|Reported Event|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105614|NCT00550446|E3|Reported Event|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1105615|NCT00550446|E2|Reported Event|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1105616|NCT00550446|E1|Reported Event|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1105617|NCT00550407|B3|Baseline|Total|Total of all reporting groups
1105618|NCT00550407|B2|Baseline|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
1105619|NCT00550407|B1|Baseline|Placebo|Matching placebo
1105620|NCT00550407|P3|Participant Flow|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
1105621|NCT00550407|P2|Participant Flow|Placebo|Matching placebo
1105622|NCT00550407|P1|Participant Flow|Lamotrigine 25-200 mg|The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually
1105623|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
1105624|NCT00550407|O1|Outcome|Placebo|Matching placebo
1105625|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
1105626|NCT00550407|O1|Outcome|Placebo|Matching placebo
1105627|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
1105628|NCT00550407|O1|Outcome|Placebo|Matching placebo
1105629|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
1105630|NCT00550407|O1|Outcome|Placebo|Matching placebo
1105631|NCT00550407|O1|Outcome|Lamotrigine 25-200 mg|The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually
1105632|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
1105633|NCT00550407|O1|Outcome|Placebo|Matching placebo
1105634|NCT00550407|O1|Outcome|Lamotrigine 25-200 mg|The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually
1105635|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
1105636|NCT00550407|O1|Outcome|Placebo|Matching placebo
1105637|NCT00550407|O1|Outcome|Lamotrigine 25-200 mg|The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually
1105638|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
1105639|NCT00550407|O1|Outcome|Placebo|Matching placebo
1105640|NCT00550407|O1|Outcome|Lamotrigine 25-200 mg|The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually
1105641|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
1105642|NCT00550407|O1|Outcome|Placebo|Matching placebo
1105643|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
1105644|NCT00550407|O1|Outcome|Placebo|Matching placebo
1105679|NCT00550368|E1|Reported Event|H. Pylori Negative|Participants who tested negative for H. pylori infection.
1105645|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
1105646|NCT00550407|O1|Outcome|Placebo|Matching placebo
1105647|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
1105648|NCT00550407|O1|Outcome|Placebo|Matching placebo
1105649|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
1105650|NCT00550407|O1|Outcome|Placebo|Matching placebo
1105651|NCT00550407|E3|Reported Event|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
1105652|NCT00550407|E2|Reported Event|Placebo|Matching placebo
1105653|NCT00550407|E1|Reported Event|Lamotrigine 25-200 mg|The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually
1105654|NCT00550394|B3|Baseline|Total|Total of all reporting groups
1105655|NCT00550394|B2|Baseline|Quitiapine andTopiramate|"Quetiapine and Topiramate~Quetiapine andTopiramate: Dosing Schedule and Titration of Quetiapine:~open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1~Dosing Schedule and Titration of Topiramate:~All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.~Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
1105656|NCT00550394|B1|Baseline|Quitiapine and Placebo|"Quetiapine and Placebo~quetiapine and placebo: Dosing Schedule and Titration of Quetiapine: open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1~Dosing Schedule and Titration of Topiramate:~All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.~Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
1105657|NCT00550394|P2|Participant Flow|Quetiapine and Topiramate|"Quetiapine and Topiramate~Quetiapine and Topiramate: Dosing Schedule and Titration of Quetiapine:~open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1~Dosing Schedule and Titration of Topiramate:~All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.~Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
1105658|NCT00550394|P1|Participant Flow|Quetiapine and Placebo|"Quetiapine and Placebo~quetiapine and placebo: Dosing Schedule and Titration of Quetiapine: open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1~Dosing Schedule and Titration of Topiramate:~All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.~Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
1105659|NCT00550394|O2|Outcome|Quetiapine and Topiramate|Quetiapine and Topiramate
1105660|NCT00550394|O1|Outcome|Quetiapine and Placebo|Quetiapine and Placebo
1105661|NCT00550394|O2|Outcome|Quetiapine and Topiramate|Quetiapine and Topiramate
1105662|NCT00550394|O1|Outcome|Quetiapine and Placebo|Quetiapine and Placebo
1105663|NCT00550394|O2|Outcome|Quetiapine and Topiramate|Quetiapine and Topiramate
1105664|NCT00550394|O1|Outcome|Quetiapine and Placebo|Quetiapine and Placebo
1105665|NCT00550394|O2|Outcome|Quetiapine + Topiramate|"Quetiapine + Topiramate~Quetiapine + Topiramate: Dosing Schedule and Titration of Quetiapine:~open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1~Dosing Schedule and Titration of Topiramate:~All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.~Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
1105666|NCT00550394|O1|Outcome|Quetiapine + Placebo|"Quetiapine + Placebo~quetiapine + placebo: Dosing Schedule and Titration of Quetiapine: open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1~Dosing Schedule and Titration of Topiramate:~All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.~Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
1105812|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
1105667|NCT00550394|E2|Reported Event|Quetiapine and Topiramate|"Quetiapine and Topiramate~Quetiapine + Topiramate: Dosing Schedule and Titration of Quetiapine:~open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1~Dosing Schedule and Titration of Topiramate:~All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.~Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
1105668|NCT00550394|E1|Reported Event|Quetiapine and Placebo|"Quetiapine and Placebo~quetiapine + placebo: Dosing Schedule and Titration of Quetiapine: open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1~Dosing Schedule and Titration of Topiramate:~All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.~Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4."
1105669|NCT00550368|B3|Baseline|Total|Total of all reporting groups
1105670|NCT00550368|B2|Baseline|H. Pylori Positive|Participants who tested H. pylori positive
1105671|NCT00550368|B1|Baseline|H. Pylori Negative|Participants who tested negative for H. pylori infection.
1105672|NCT00550368|P2|Participant Flow|H. Pylori Positive|Participants who tested H. pylori positive
1105673|NCT00550368|P1|Participant Flow|H. Pylori Negative|Participants who tested negative for H. pylori infection.
1105674|NCT00550368|O2|Outcome|H. Pylori Positive|Participants who tested H. pylori positive
1105675|NCT00550368|O1|Outcome|H. Pylori Negative|Participants who tested negative for H. pylori infection.
1105676|NCT00550368|O2|Outcome|H. Pylori Positive|Participants who tested H. pylori positive
1105677|NCT00550368|O1|Outcome|H. Pylori Negative|Participants who tested negative for H. pylori infection.
1105678|NCT00550368|E2|Reported Event|H. Pylori Positive|Participants who tested H. pylori positive
1105681|NCT00549601|B3|Baseline|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
1105682|NCT00549601|B2|Baseline|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
1105683|NCT00549601|B1|Baseline|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
1105684|NCT00549601|P3|Participant Flow|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
1105685|NCT00549601|P2|Participant Flow|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
1105686|NCT00549601|P1|Participant Flow|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
1105687|NCT00549601|O3|Outcome|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
1105688|NCT00549601|O2|Outcome|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
1105689|NCT00549601|O1|Outcome|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
1105690|NCT00549601|O3|Outcome|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
1105691|NCT00549601|O2|Outcome|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
1105692|NCT00549601|O1|Outcome|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
1105693|NCT00549601|O3|Outcome|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
1105694|NCT00549601|O2|Outcome|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
1105695|NCT00549601|O1|Outcome|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
1105696|NCT00549601|O3|Outcome|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
1105697|NCT00549601|O2|Outcome|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
1105698|NCT00549601|O1|Outcome|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
1105699|NCT00549601|O2|Outcome|Rivastigmine 9.5 mg Patch|Rivastigmine transdermal patches at a constant dose: Application of one 9.5 mg patch every day for the whole treatment period.
1105700|NCT00549601|O1|Outcome|Rivastigmine 4.6 mg/9.5 mg Patch|Rivastigmine transdermal patches at increasing doses: Application of one 4.6 mg patch every day for the first month of treatment and thereafter daily application of one 9.5 mg patch for the next two months.
1105701|NCT00549601|O3|Outcome|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
1105702|NCT00549601|O2|Outcome|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
1105703|NCT00549601|O1|Outcome|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
1105704|NCT00549601|E3|Reported Event|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
1105705|NCT00549601|E2|Reported Event|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
1105706|NCT00549601|E1|Reported Event|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
1105707|NCT00549562|B1|Baseline|Paliperidone ER|"8-Week Open-Label~Paliperidone ER: starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day."
1105708|NCT00549562|P1|Participant Flow|Paliperidone ER|"8-Week Open-Label~Paliperidone ER: Starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day."
1105709|NCT00549562|O1|Outcome|Paliperidone ER|"8-Week Open-Label~Paliperidone ER: Starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day."
1105710|NCT00549562|O1|Outcome|Paliperidone ER|"8-Week Open-Label~Paliperidone ER: Starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day."
1105767|NCT00550147|O3|Outcome|Visit 10 - MPH+Quetiapine - Week 13|Score following treatment with combined MPH and quetiapine after Week 13
1105711|NCT00549562|O1|Outcome|Paliperidone ER|"8-Week Open-Label~Paliperidone ER: Starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day."
1105712|NCT00549562|O1|Outcome|Paliperidone ER|"8-Week Open-Label~Paliperidone ER: Starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day."
1105713|NCT00549562|O1|Outcome|Paliperidone ER|"8-Week Open-Label~Paliperidone ER: Starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day."
1105714|NCT00549562|E1|Reported Event|Paliperidone ER|"8-Week Open-Label~Paliperidone ER: Starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day."
1105715|NCT00550277|B1|Baseline|Treatment|LBH589 will be administered orally at a dose of 45 mg (1 - 5 mg capsule and 2 – 20 mg capsules) on Monday and Thursday of each week (twice weekly). To enable patients to undergo cardiac monitoring, all patients must begin treatment on a Monday, and continue Monday/Thursday dosing during subsequent treatment cycles. Patients with objective response or stable disease after re-evaluation at week 8 will continue LBH589 at the same dose until disease progression, unacceptable toxicity and/or at the discretion of the investigator.
1105716|NCT00550277|P1|Participant Flow|Treatment|LBH589 will be administered orally at a dose of 45 mg (1 - 5 mg capsule and 2 – 20 mg capsules) on Monday and Thursday of each week (twice weekly). To enable patients to undergo cardiac monitoring, all patients must begin treatment on a Monday, and continue Monday/Thursday dosing during subsequent treatment cycles. Patients with objective response or stable disease after re-evaluation at week 8 will continue LBH589 at the same dose until disease progression, unacceptable toxicity and/or at the discretion of the investigator.
1105717|NCT00550277|O1|Outcome|Treatment|LBH589 will be administered orally at a dose of 45 mg (1 - 5 mg capsule and 2 - 20 mg capsules) on Monday and Thursday of each week (twice weekly). To enable patients to undergo cardiac monitoring, all patients must begin treatment on a Monday, and continue Monday/Thursday dosing during subsequent treatment cycles. Patients with objective response or stable disease after re-evaluation at week 8 will continue LBH589 at the same dose until disease progression, unacceptable toxicity and/or at the discretion of the investigator.
1105718|NCT00550277|E1|Reported Event|Treatment|LBH589 will be administered orally at a dose of 45 mg (1 - 5 mg capsule and 2 – 20 mg capsules) on Monday and Thursday of each week (twice weekly). To enable patients to undergo cardiac monitoring, all patients must begin treatment on a Monday, and continue Monday/Thursday dosing during subsequent treatment cycles. Patients with objective response or stable disease after re-evaluation at week 8 will continue LBH589 at the same dose until disease progression, unacceptable toxicity and/or at the discretion of the investigator.
1105719|NCT00550173|B4|Baseline|Total|Total of all reporting groups
1105720|NCT00550173|B3|Baseline|Pemetrexed|Pemetrexed 500 mg/m^2 of body surface area, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
1105721|NCT00550173|B2|Baseline|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
1105722|NCT00550173|B1|Baseline|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of body surface area, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
1105723|NCT00550173|P3|Participant Flow|Pemetrexed|Pemetrexed 500 mg/m^2 of body surface area, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
1105724|NCT00550173|P2|Participant Flow|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
1105725|NCT00550173|P1|Participant Flow|Pemetrexed + Erlotinib|Pemetrexed 500 milligrams per meter squared (mg/m^2) of body surface area, administered by intravenous (IV) infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
1105726|NCT00550173|O3|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
1105727|NCT00550173|O2|Outcome|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
1105728|NCT00550173|O1|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
1105729|NCT00550173|O3|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
1105730|NCT00550173|O2|Outcome|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
1105731|NCT00550173|O1|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
1105732|NCT00550173|O3|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
1105733|NCT00550173|O2|Outcome|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
1105734|NCT00550173|O1|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
1105735|NCT00550173|O3|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
1105736|NCT00550173|O2|Outcome|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
1105849|NCT00549939|O1|Outcome|Placebo|
1105737|NCT00550173|O1|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of body surface area, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
1105738|NCT00550173|O3|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
1105739|NCT00550173|O2|Outcome|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
1105740|NCT00550173|O1|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
1105741|NCT00550173|O3|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
1105742|NCT00550173|O2|Outcome|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
1105743|NCT00550173|O1|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
1105744|NCT00550173|O3|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
1105745|NCT00550173|O2|Outcome|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
1105746|NCT00550173|O1|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
1105747|NCT00550173|O3|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
1105748|NCT00550173|O2|Outcome|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
1105749|NCT00550173|O1|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
1105750|NCT00550173|E3|Reported Event|Pemetrexed|Participants received pemetrexed 500 mg/m^2 of body surface area, administered by intravenous (IV) infusion on Day 1 of each 21 day cycle until progression or unacceptable toxicity developed up to 39 months.
1105751|NCT00550173|E2|Reported Event|Erlotinib|Participants received erlotinib 150 mg, administered orally once daily in each 21 day cycle until disease progression or unacceptable toxicity developed up to 39 months.
1105752|NCT00550173|E1|Reported Event|Pemetrexed + Erlotinib|Participants received pemetrexed 500 milligrams per meter squared (mg/m^2) of body surface area, administered by intravenous (IV) infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21 day cycle until disease progression or unacceptable toxicity developed up to 39 months.
1105753|NCT00550147|B1|Baseline|OROS Methylphenidate and Quetiapine|All enrolled subjects start taking OROS methylphenidate. At visit 5, if there is significant improvement (decrease in aggressive symptoms), then subject is discontinued from the study. If there is not significant improvement, then subject continues in study and begins taking OROS methylphenidate plus quetiapine. Therefore enters the OROS methylphenidate and quetiapine arm. 24 of 30 subjects entered the OROS methylphenidate and quetiapine arm. 4 subjects made significant improvement at visit 5 and were discontinued from the study, and, therefore, did not enter the OROS methylphenidate and quetiapine arm. 2 subjects were withdrawn from the study prior to visit 5, and, therefore, did not enter the OROS methylphenidate and quetiapine arm. Therefore, 6 of 30 subjects did not enter the OROS methylphenidate and quetiapine arm. Only 24 of 30 subjects entered this arm.
1105813|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
1105814|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
1105815|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
1105816|NCT00550043|O1|Outcome|Placebo|
1105754|NCT00550147|P1|Participant Flow|OROS Methylphenidate and Quetiapine|This is the Baseline Visit, immediately after enrollment and prior to taking any medication. All enrolled subjects start taking OROS methylphenidate until Visit 5. At visit 5, if there is significant improvement (decrease in aggressive symptoms), then subject is discontinued from the study. If there is not significant improvement, then subject continues in study and begins taking OROS methylphenidate plus quetiapine. 24 of 30 subjects entered the OROS methylphenidate and quetiapine arm. 4 subjects made significant improvement at visit 5 and were discontinued from the study; 2 subjects were withdrawn from the study prior to visit 5. Therefore, 6 of 30 subjects did not enter the OROS methylphenidate and quetiapine arm. Only 24 of 30 subjects entered this arm. Visit 10 is measured at the end of OROS MPH+Quetiapine treatment
1105755|NCT00550147|O3|Outcome|Visit 10 - MPH+Quetiapine - Week 13|Score following treatment with MPH+Quetiapine after Week 13
1105756|NCT00550147|O2|Outcome|Visit 5 - MPH Monotherapy - Week 4|Score following treatment with MPH monotherapy after week 4
1105757|NCT00550147|O1|Outcome|Baseline|Baseline scores at study entry
1105758|NCT00550147|O3|Outcome|Visit 10 - MPH+Quetiapine - Week 13|Score following treatment with MPH+quetiapine after Week 13
1105759|NCT00550147|O2|Outcome|Visit 5 - MPH Monotherapy - Week 4|Score following treatment with MPH Monotherapy after Week 4
1105760|NCT00550147|O1|Outcome|Baseline|Baseline scores at Study Entry
1105761|NCT00550147|O3|Outcome|Visit 10 - MPH + Quetiapine - Week 13|Score following treatment with MPH+quetiapine after Week 13
1105762|NCT00550147|O2|Outcome|Visit 5 - MPH Monotherapy - Week 4|Score following treatment with MPH monotherapy after Week 4
1105763|NCT00550147|O1|Outcome|Baseline|Baseline scores at study entry
1105764|NCT00550147|O3|Outcome|Visit 10 - MPH + Quetiapine - Week 13|Score following treatment with MPH+quetiapine after Week 13
1105768|NCT00550147|O2|Outcome|Visit 5 - MPH Monotherapy - Week 4|Score following treatment with MPH monotherapy after Week 4
1105769|NCT00550147|O1|Outcome|Baseline|Baseline score at study entry
1105770|NCT00550147|E1|Reported Event|OROS Methylphenidate and Quetiapine|All enrolled subjects start taking OROS methylphenidate. At visit 5, if there is significant improvement (decrease in aggressive symptoms), then subject is discontinued from the study. If there is not significant improvement, then subject continues in study and begins taking OROS methylphenidate plus quetiapine. Therefore enters the OROS methylphenidate and quetiapine arm. 24 of 30 subjects entered the OROS methylphenidate and quetiapine arm. 4 subjects made significant improvement at visit 5 and were discontinued from the study, and, therefore, did not enter the OROS methylphenidate and quetiapine arm. 2 subjects were withdrawn from the study prior to visit 5, and, therefore, did not enter the OROS methylphenidate and quetiapine arm. Therefore, 6 of 30 subjects did not enter the OROS methylphenidate and quetiapine arm. Only 24 of 30 subjects entered this arm.
1105771|NCT00550043|B6|Baseline|Total|Total of all reporting groups
1105772|NCT00550043|B5|Baseline|Cohort 2: Treatment Group D|INCB018424 50 mg QD
1105773|NCT00550043|B4|Baseline|Cohort 2: Treatment Group C|INCB018424 25 mg BID
1105774|NCT00550043|B3|Baseline|Cohort 2: Treatment Group B|INCB018424 5 mg BID
1105775|NCT00550043|B2|Baseline|Cohort 1: Treatment Group A|INCB018424 15 mg BID
1105776|NCT00550043|B1|Baseline|Placebo|
1105777|NCT00550043|P5|Participant Flow|Cohort 2: Treatment Group D|INCB018424 50 mg QD
1105778|NCT00550043|P4|Participant Flow|Cohort 2: Treatment Group C|INCB018424 25 mg BID
1105779|NCT00550043|P3|Participant Flow|Cohort 2: Treatment Group B|INCB018424 5 mg BID
1105780|NCT00550043|P2|Participant Flow|Cohort 1: Treatment Group A|INCB018424 15 mg BID
1105781|NCT00550043|P1|Participant Flow|Placebo|
1105782|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
1105783|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
1105784|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
1105785|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
1105786|NCT00550043|O1|Outcome|Placebo|
1105787|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
1105788|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
1105789|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
1105790|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
1105791|NCT00550043|O1|Outcome|Placebo|
1105792|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
1105793|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
1105794|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
1105795|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
1105796|NCT00550043|O1|Outcome|Placebo|
1105797|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
1105798|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
1105799|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
1105800|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
1105801|NCT00550043|O1|Outcome|Placebo|
1105802|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
1105803|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
1105804|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
1105805|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
1105806|NCT00550043|O1|Outcome|Placebo|
1105807|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
1105808|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
1105809|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
1105810|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
1105811|NCT00550043|O1|Outcome|Placebo|
1105820|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
1105821|NCT00550043|O1|Outcome|Placebo|
1105822|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
1105823|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
1105824|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
1105825|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
1105826|NCT00550043|O1|Outcome|Placebo|
1105827|NCT00550043|E5|Reported Event|Cohort 2: Treatment Group D|INCB018424 50 mg QD
1105828|NCT00550043|E4|Reported Event|Cohort 2: Treatment Group C|INCB018424 25 mg BID
1105829|NCT00550043|E3|Reported Event|Cohort 2: Treatment Group B|INCB018424 5 mg BID
1105830|NCT00550043|E2|Reported Event|Cohort 1: Treatment Group A|INCB018424 15 mg BID
1105831|NCT00550043|E1|Reported Event|Placebo|
1105832|NCT00549939|B4|Baseline|Total|Total of all reporting groups
1105833|NCT00549939|B3|Baseline|Alfuzosin 0.2 mg/kg/Day|
1105834|NCT00549939|B2|Baseline|Alfuzosin 0.1 mg/kg/Day|
1105835|NCT00549939|B1|Baseline|Placebo|Alfuzosin 0.1 mg/kg/day matching placebo or Alfuzosin 0.2 mg/kg/day matching placebo
1105836|NCT00549939|P3|Participant Flow|Alfuzosin 0.2 mg/kg/Day|
1105837|NCT00549939|P2|Participant Flow|Alfuzosin 0.1 mg/kg/Day|
1105838|NCT00549939|P1|Participant Flow|Placebo|Alfuzosin 0.1 mg/kg/day matching placebo or Alfuzosin 0.2 mg/kg/day matching placebo
1105839|NCT00549939|O2|Outcome|Alfuzosin 0.2 mg/kg/Day|
1105840|NCT00549939|O1|Outcome|Alfuzosin 0.1 mg/kg/Day|
1105841|NCT00549939|O3|Outcome|Alfuzosin 0.2 mg/kg/Day|
1105842|NCT00549939|O2|Outcome|Alfuzosin 0.1 mg/kg/Day|
1105843|NCT00549939|O1|Outcome|Placebo|
1105844|NCT00549939|O3|Outcome|Alfuzosin 0.2 mg/kg/Day|
1105845|NCT00549939|O2|Outcome|Alfuzosin 0.1 mg/kg/Day|
1105846|NCT00549939|O1|Outcome|Placebo|
1105847|NCT00549939|O3|Outcome|Alfuzosin 0.2 mg/kg/Day|
1105848|NCT00549939|O2|Outcome|Alfuzosin 0.1 mg/kg/Day|
1105861|NCT00549939|O1|Outcome|Placebo|Alfuzosin 0.1 mg/kg/day matching placebo or Alfuzosin 0.2 mg/kg/day matching placebo
1105862|NCT00549939|E2|Reported Event|Alfuzosin 0.2 mg/kg/Day|
1105863|NCT00549939|E1|Reported Event|Alfuzosin 0.1 mg/kg/Day|
1105864|NCT00549900|B1|Baseline|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
1105865|NCT00549900|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
1105866|NCT00549900|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
1105867|NCT00549900|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
1105868|NCT00549900|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
1105869|NCT00549900|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
1105870|NCT00549900|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
1105871|NCT00549900|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
1105872|NCT00549900|E1|Reported Event|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
1105873|NCT00549822|B1|Baseline|Intermittent Letrozole Therapy|"Letrozole 2.5mg: Intermittently~Letrozole 2.5 mg administered by mouth each day during each 28 day treatment cycle. Treatment is intermittent with possible breaks between each 28 day treatment cycle. Letrozole is administered until the participant has disease progression as determined by RECIST (Response Evaluation Criteria In Solid Tumors), experiences severe side effects, or decides to stop treatment."
1105874|NCT00549822|P1|Participant Flow|Intermittent Letrozole Therapy|"Letrozole 2.5mg: Intermittently~Letrozole 2.5 mg administered by mouth each day during each 28 day treatment cycle. Treatment is intermittent with possible breaks between each 28 day treatment cycle. Letrozole is administered until the participant has disease progression as determined by RECIST (Response Evaluation Criteria In Solid Tumors), experiences severe side effects, or decides to stop treatment."
1105875|NCT00549822|O1|Outcome|Intermittent Letrozole Therapy|"Letrozole 2.5mg: Intermittently~Letrozole 2.5 mg administered by mouth each day during each 28 day treatment cycle. Treatment is intermittent with possible breaks between each 28 day treatment cycle. Letrozole is administered until the participant has disease progression as determined by RECIST (Response Evaluation Criteria In Solid Tumors), experiences severe side effects, or decides to stop treatment."
1105876|NCT00549822|O1|Outcome|Intermittent Letrozole Therapy|"Letrozole 2.5mg: Intermittently~Letrozole 2.5 mg administered by mouth each day during each 28 day treatment cycle. Treatment is intermittent with possible breaks between each 28 day treatment cycle. Letrozole is administered until the participant has disease progression as determined by RECIST (Response Evaluation Criteria In Solid Tumors), experiences severe side effects, or decides to stop treatment."
1106187|NCT00549393|O1|Outcome|Treatment Arm|"Daily bathing with 2% chlorhexidine gluconate~2% Chlorhexidine gluconate cloth: Daily bathing"
1105877|NCT00549822|O1|Outcome|Intermittent Letrozole Therapy|"Letrozole 2.5mg: Intermittently~Letrozole 2.5 mg administered by mouth each day during each 28 day treatment cycle. Treatment is intermittent with possible breaks between each 28 day treatment cycle. Letrozole is administered until the participant has disease progression as determined by RECIST (Response Evaluation Criteria In Solid Tumors), experiences severe side effects, or decides to stop treatment."
1105878|NCT00549822|E1|Reported Event|Intermittent Letrozole Therapy|Letrozole 2.5mg: Intermittently
1105879|NCT00549783|B3|Baseline|Total|Total of all reporting groups
1105880|NCT00549783|B2|Baseline|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
1105881|NCT00549783|B1|Baseline|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
1105882|NCT00549783|P2|Participant Flow|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
1105883|NCT00549783|P1|Participant Flow|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
1105884|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
1105885|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
1105886|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
1105887|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
1105888|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
1105889|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
1105921|NCT00549770|P8|Participant Flow|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105890|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
1105891|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
1105892|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
1105893|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
1105894|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
1105895|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
1105896|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
1105897|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
1105898|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
1105899|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
1105900|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
1105901|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
1105902|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
1105903|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
1105904|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
1105905|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
1106188|NCT00549393|E2|Reported Event|Control Arm|Standard bathing with soap and water basin or disposable cloth
1105906|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
1105907|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
1105908|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
1105909|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
1105910|NCT00549783|E2|Reported Event|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
1105911|NCT00549783|E1|Reported Event|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
1105912|NCT00549770|B9|Baseline|Total|Total of all reporting groups
1105913|NCT00549770|B8|Baseline|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105914|NCT00549770|B7|Baseline|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
1105915|NCT00549770|B6|Baseline|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105916|NCT00549770|B5|Baseline|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105917|NCT00549770|B4|Baseline|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105918|NCT00549770|B3|Baseline|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105919|NCT00549770|B2|Baseline|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105920|NCT00549770|B1|Baseline|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1106938|NCT00546871|O4|Outcome|Study Part 3b, SC Administration|
1105922|NCT00549770|P7|Participant Flow|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
1105923|NCT00549770|P6|Participant Flow|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105924|NCT00549770|P5|Participant Flow|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105925|NCT00549770|P4|Participant Flow|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105926|NCT00549770|P3|Participant Flow|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105927|NCT00549770|P2|Participant Flow|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105928|NCT00549770|P1|Participant Flow|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105929|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105930|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
1105931|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105932|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105933|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105934|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105935|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105936|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105937|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105938|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
1105939|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105940|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105941|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105942|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105943|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105944|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105945|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105946|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
1105947|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105948|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105949|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105950|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105951|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105952|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105953|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105954|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
1105955|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105956|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105957|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105958|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105959|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105960|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105961|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105962|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
1105963|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105964|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105965|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105966|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105967|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105968|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105969|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105970|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
1105971|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105972|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105973|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105974|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105975|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105976|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105977|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105978|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
1106189|NCT00549393|E1|Reported Event|Treatment Arm|"Daily bathing with 2% chlorhexidine gluconate~2% Chlorhexidine gluconate cloth: Daily bathing"
1105979|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105980|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105981|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105982|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105983|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105984|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105985|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105986|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
1105987|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105988|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105989|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105990|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105991|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105992|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105993|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105994|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
1105995|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105996|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105997|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105998|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1105999|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1106000|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1106001|NCT00549770|E8|Reported Event|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1106002|NCT00549770|E7|Reported Event|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
1106003|NCT00549770|E6|Reported Event|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1106004|NCT00549770|E5|Reported Event|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1106005|NCT00549770|E4|Reported Event|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1106006|NCT00549770|E3|Reported Event|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1106007|NCT00549770|E2|Reported Event|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1106008|NCT00549770|E1|Reported Event|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
1106009|NCT00549757|B3|Baseline|Total|Total of all reporting groups
1106010|NCT00549757|B2|Baseline|Placebo|"In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.~With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment."
1106011|NCT00549757|B1|Baseline|Aliskiren|"In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.~With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment."
1106190|NCT00549328|B1|Baseline|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
1106012|NCT00549757|P2|Participant Flow|Placebo|"In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.~With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment."
1106013|NCT00549757|P1|Participant Flow|Aliskiren|"In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.~With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment."
1106014|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
1106015|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
1106016|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
1106017|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
1106018|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
1106019|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
1106939|NCT00546871|O3|Outcome|Study Part 3a, SC Administration|
1106020|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
1106021|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
1106022|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
1106023|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
1106024|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
1106025|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
1106026|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
1106027|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
1106028|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
1106029|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
1106030|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
1106031|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
1106032|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
1106033|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
1106034|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
1106191|NCT00549328|P1|Participant Flow|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
1106035|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
1106036|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
1106037|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
1106038|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
1106039|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
1106040|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
1106041|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
1106042|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
1106043|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
1106044|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
1106940|NCT00546871|O2|Outcome|Study Part 2, SC Administration|
1106045|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
1106046|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
1106047|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
1106048|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
1106049|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
1106050|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
1106051|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
1106052|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
1106053|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
1106054|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
1106055|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
1106097|NCT00549640|O1|Outcome|Methylphenidate|osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily)
1106056|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
1106057|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
1106058|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
1106059|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
1106060|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
1106061|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
1106062|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
1106114|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
1106502|NCT00548340|O1|Outcome|VEC-162 20 mg|VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks
1106063|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
1106064|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
1106065|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
1106066|NCT00549757|E4|Reported Event|Extension-phase: Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
1106067|NCT00549757|E3|Reported Event|Extension-phase: Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
1106068|NCT00549757|E2|Reported Event|Core-phase: Placebo|In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until final closure of the study.
1106069|NCT00549757|E1|Reported Event|Core-phase: Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
1106070|NCT00549718|B5|Baseline|Total|Total of all reporting groups
1106071|NCT00549718|B4|Baseline|Placebo|Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
1106072|NCT00549718|B3|Baseline|Lurasidone 120mg|Lurasidone 40 mg tablets taken once/day
1106073|NCT00549718|B2|Baseline|Lurasidone 80mg|lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
1106074|NCT00549718|B1|Baseline|Lurasidone 40mg|Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
1106098|NCT00549640|O2|Outcome|Placebo|Look alike placebo pill with same dosing schedule as active methylphenidate
1106075|NCT00549718|P4|Participant Flow|Placebo|Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
1106076|NCT00549718|P3|Participant Flow|Lurasidone 120mg|Lurasidone 40 mg tablets taken once/day
1106077|NCT00549718|P2|Participant Flow|Lurasidone 80mg|lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
1106078|NCT00549718|P1|Participant Flow|Lurasidone 40mg|Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
1106079|NCT00549718|O4|Outcome|Placebo|Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
1106080|NCT00549718|O3|Outcome|Lurasidone 120mg|Lurasidone 40 mg tablets taken once/day
1106081|NCT00549718|O2|Outcome|Lurasidone 80mg|lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
1106115|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
1106941|NCT00546871|O1|Outcome|Study Part 1, IV Administration|
1106082|NCT00549718|O1|Outcome|Lurasidone 40mg|Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
1106083|NCT00549718|O4|Outcome|Placebo|Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
1106084|NCT00549718|O3|Outcome|Lurasidone 120mg|Lurasidone 40 mg tablets taken once/day
1106085|NCT00549718|O2|Outcome|Lurasidone 80mg|lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
1106086|NCT00549718|O1|Outcome|Lurasidone 40mg|Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
1106087|NCT00549718|E4|Reported Event|Placebo|Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
1106088|NCT00549718|E3|Reported Event|Lurasidone 120mg|Lurasidone 40 mg tablets taken once/day
1106089|NCT00549718|E2|Reported Event|Lurasidone 80mg|lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
1106090|NCT00549718|E1|Reported Event|Lurasidone 40mg|Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
1106091|NCT00549640|B3|Baseline|Total|Total of all reporting groups
1106092|NCT00549640|B2|Baseline|Placebo|Look alike placebo pill with same dosing schedule as active methylphenidate
1106093|NCT00549640|B1|Baseline|Methylphenidate|osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily)
1106094|NCT00549640|P2|Participant Flow|Placebo|Look alike placebo pill with same dosing schedule as active methylphenidate
1106095|NCT00549640|P1|Participant Flow|Methylphenidate|osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily)
1106096|NCT00549640|O2|Outcome|Placebo|Look alike placebo pill with same dosing schedule as active methylphenidate
1106141|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
1106099|NCT00549640|O1|Outcome|Methylphenidate|osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily)
1106100|NCT00549640|O2|Outcome|Placebo|Look alike placebo pill with same dosing schedule as active methylphenidate
1106101|NCT00549640|O1|Outcome|Methylphenidate|osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily)
1106102|NCT00549640|E2|Reported Event|Placebo|Look alike placebo pill with same dosing schedule as active methylphenidate
1106103|NCT00549640|E1|Reported Event|Methylphenidate|osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily)
1106104|NCT00549549|B5|Baseline|Total|Total of all reporting groups
1106105|NCT00549549|B4|Baseline|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
1106106|NCT00549549|B3|Baseline|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
1106107|NCT00549549|B2|Baseline|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
1106108|NCT00549549|B1|Baseline|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
1106109|NCT00549549|P4|Participant Flow|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
1106110|NCT00549549|P3|Participant Flow|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
1106111|NCT00549549|P2|Participant Flow|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
1106112|NCT00549549|P1|Participant Flow|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
1106113|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
1106118|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
1106119|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
1106120|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
1106121|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
1106122|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
1106123|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
1106124|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
1106125|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
1106126|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
1106127|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
1106128|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
1106129|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
1106130|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
1106131|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
1106132|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
1106133|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
1106134|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
1106135|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
1106136|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
1106137|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
1106138|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
1106139|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
1106140|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
1106142|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
1106143|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
1106144|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
1106145|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
1106146|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
1106147|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
1106148|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
1106149|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
1106150|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
1106151|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
1106152|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
1106153|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
1106154|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
1106155|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
1106156|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
1106157|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
1106158|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
1106159|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
1106160|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
1106162|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
1106163|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
1106164|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
1106165|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
1106166|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
1106167|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
1106168|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
1106169|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
1106170|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
1106171|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
1106172|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
1106173|NCT00549549|E4|Reported Event|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
1106174|NCT00549549|E3|Reported Event|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
1106175|NCT00549549|E2|Reported Event|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
1106176|NCT00549549|E1|Reported Event|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
1106177|NCT00549393|B3|Baseline|Total|Total of all reporting groups
1106178|NCT00549393|B2|Baseline|Control Arm|Standard bathing with soap and water basin or disposable cloth
1106179|NCT00549393|B1|Baseline|Treatment Arm|"Daily bathing with 2% chlorhexidine gluconate~2% Chlorhexidine gluconate cloth: Daily bathing"
1106180|NCT00549393|P2|Participant Flow|Standard Bath|Standard bathing with soap and water basin or disposable cloth
1106181|NCT00549393|P1|Participant Flow|2% Chlorhexidine Gluconate Cloth|"Daily bathing with 2% chlorhexidine gluconate~2% Chlorhexidine gluconate cloth: Daily bathing"
1106182|NCT00549393|O2|Outcome|Control|Standard bathing with soap and water basin or disposable cloth
1106183|NCT00549393|O1|Outcome|Treatment|Daily bathing with 2% chlorhexidine gluconate
1106184|NCT00549393|O2|Outcome|Control Arm|Standard bathing with soap and water basin or disposable cloth
1106185|NCT00549393|O1|Outcome|Treatment Arm|"Daily bathing with 2% chlorhexidine gluconate~2% Chlorhexidine gluconate cloth: Daily bathing"
1106186|NCT00549393|O2|Outcome|Control Arm|Standard bathing with soap and water basin or disposable cloth
1106192|NCT00549328|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
1106193|NCT00549328|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
1106194|NCT00549328|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
1106195|NCT00549328|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
1106196|NCT00549328|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
1106197|NCT00549328|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
1106198|NCT00549328|E1|Reported Event|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
1106199|NCT00549302|B3|Baseline|Total|Total of all reporting groups
1106200|NCT00549302|B2|Baseline|Tadalafil 40 mg Double-Blind|Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Day 1 up to 52 weeks of treatment.
1106201|NCT00549302|B1|Baseline|Tadalafil 20 Milligrams (mg) Double-Blind|Tadalafil, 20 milligram (mg) administered orally as 1 tadalafil tablet and 1 matched placebo tablet once daily from Day 1 up to 52 weeks of treatment.
1106202|NCT00549302|P3|Participant Flow|Tadalafil 40 mg Open-Label|Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Week 53 up to Week 243.
1106203|NCT00549302|P2|Participant Flow|Tadalafil 40 mg Double-Blind|Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Day 1 up to 52 weeks of treatment.
1106204|NCT00549302|P1|Participant Flow|Tadalafil 20 mg Double Blind|Tadalafil, 20 milligram (mg) administered orally as 1 tadalafil tablet and 1 matched placebo tablet once daily from Day 1 up to 52 weeks of treatment.
1106205|NCT00549302|O2|Outcome|Tadalafil 40 mg Double-Blind|Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Day 1 up to 52 weeks of treatment.
1106206|NCT00549302|O1|Outcome|Tadalafil 20 Milligrams (mg) Double-Blind|Tadalafil, 20 milligram (mg) administered orally as 1 tadalafil tablet and 1 matched placebo tablet once daily from Day 1 up to 52 weeks of treatment.
1106207|NCT00549302|O2|Outcome|Tadalafil 40 mg|Tadalafil, two 20 mg tablets (40 mg total) administered orally once per day from Day 1 up to 52 weeks of treatment.
1106208|NCT00549302|O1|Outcome|Tadalalfil 20 Milligrams (mg)|Tadalafil, 20 milligram (mg) tablets administered orally as one tablet tadalafil and one tablet matched placebo once per day from Day 1 up to 52 weeks of treatment; LOCF.
1106209|NCT00549302|O2|Outcome|Tadalafil 40 mg Double-Blind|Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Day 1 up to 52 weeks of treatment.
1106210|NCT00549302|O1|Outcome|Tadalafil 20 Milligrams (mg) Double-Blind|Tadalafil, 20 milligram (mg) administered orally as 1 tadalafil tablet and 1 matched placebo tablet once daily from Day 1 up to 52 weeks of treatment.
1106253|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106211|NCT00549302|O1|Outcome|Tadalafil 20 mg or 40 mg Double-Blind and 40 mg Open-Label|Tadalafil 20 mg tablets administered orally as one tablet tadalafil and one tablet matched placebo once per day from Day 1 up to 52 weeks of treatment or tadalafil, two 20 mg tablets (40 mg total) administered orally once per day from Day 1 up to 52 weeks of treatment in Double-blind period; and tadalafil, two 20 mg tablets (40 mg total) administered orally once per day from Week 53 up to Week 243 in Open-label period.
1106212|NCT00549302|E1|Reported Event|Tadalafil 20 mg or 40 mg Double-Blind and 40 mg Open-Label|Tadalafil 20 mg administered orally as 1 tadalafil 20-mg tablet and 1 matched placebo tablet, once daily from Day 1 up to 52 weeks of treatment, or tadalafil 40 mg (two 20-mg tablets) administered orally, once daily from Day 1 up to 52 weeks of treatment in Double-Blind Period; and tadalafil 40 mg (two 20-mg tablets) administered orally, once daily from Week 53 up to Week 243 in Open-Label Period.
1106213|NCT00549198|B3|Baseline|Total|Total of all reporting groups
1106214|NCT00549198|B2|Baseline|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106215|NCT00549198|B1|Baseline|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106216|NCT00549198|P2|Participant Flow|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106217|NCT00549198|P1|Participant Flow|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106218|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106219|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106220|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106221|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106222|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106223|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106224|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106225|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106226|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106227|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106228|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106229|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106230|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106231|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106232|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1108646|NCT00542425|E3|Reported Event|BA058 40 µg|
1106233|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106234|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106235|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106236|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106237|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106238|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106239|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106240|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106241|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106242|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106243|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106244|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106245|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106246|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106247|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106248|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106249|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106250|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106251|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106252|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106254|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106255|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106256|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106257|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106258|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106259|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106260|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106261|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106262|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106263|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106264|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106265|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106266|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106267|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106268|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106269|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106270|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106271|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106272|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106273|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106274|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106275|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106276|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106277|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106278|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106279|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106280|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106281|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106282|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106283|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106284|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106285|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106286|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106287|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106288|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106289|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106290|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106291|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106292|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106293|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106294|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106295|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106296|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106297|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106298|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106299|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106300|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106301|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106302|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106303|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106304|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106305|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106306|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106307|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106308|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106309|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106310|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106311|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106312|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106313|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106314|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106315|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106316|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106317|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106318|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106319|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106320|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106321|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106322|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106323|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106324|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106325|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106326|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106327|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106328|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106329|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106330|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106331|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106332|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106333|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106334|NCT00549198|E2|Reported Event|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
1106335|NCT00549198|E1|Reported Event|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
1106336|NCT00549172|B3|Baseline|Total|Total of all reporting groups
1106337|NCT00549172|B2|Baseline|Conservative (K)|"Arthroscopy (diagnostic)~Conservative (diagnostic arthroscopy): Diagnostic arthroscopy~n=76"
1106338|NCT00549172|B1|Baseline|Operative (O)|"Partial resection of degenerative tear of medial meniscus~Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus~n=70"
1106339|NCT00549172|P2|Participant Flow|Conservative (K)|"Arthroscopy (diagnostic)~Conservative (diagnostic arthroscopy): Diagnostic arthroscopy~n=76"
1106340|NCT00549172|P1|Participant Flow|Operative (O)|"Partial resection of degenerative tear of medial meniscus~Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus~n=70"
1106341|NCT00549172|O2|Outcome|Conservative (K)|"Arthroscopy (diagnostic)~Conservative (diagnostic arthroscopy): Diagnostic arthroscopy~n=76"
1106342|NCT00549172|O1|Outcome|Operative (O)|"Partial resection of degenerative tear of medial meniscus~Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus~n=70"
1106343|NCT00549172|O2|Outcome|Conservative (K)|"Arthroscopy (diagnostic)~Conservative (diagnostic arthroscopy): Diagnostic arthroscopy~n=76"
1106344|NCT00549172|O1|Outcome|Operative (O)|"Partial resection of degenerative tear of medial meniscus~Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus~n=70"
1106345|NCT00549172|O2|Outcome|Conservative (K)|"Arthroscopy (diagnostic)~Conservative (diagnostic arthroscopy): Diagnostic arthroscopy~n=76"
1106346|NCT00549172|O1|Outcome|Operative (O)|"Partial resection of degenerative tear of medial meniscus~Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus~n=70"
1106347|NCT00549172|O2|Outcome|Conservative (K)|"Arthroscopy (diagnostic)~Conservative (diagnostic arthroscopy): Diagnostic arthroscopy~n=76"
1106348|NCT00549172|O1|Outcome|Operative (O)|"Partial resection of degenerative tear of medial meniscus~Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus~n=70"
1106349|NCT00549172|O2|Outcome|Conservative (K)|"Arthroscopy (diagnostic)~Conservative (diagnostic arthroscopy): Diagnostic arthroscopy~n=76"
1106350|NCT00549172|O1|Outcome|Operative (O)|"Partial resection of degenerative tear of medial meniscus~Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus~n=70"
1106351|NCT00549172|E2|Reported Event|Conservative (K)|"Arthroscopy (diagnostic)~Conservative (diagnostic arthroscopy): Diagnostic arthroscopy"
1106352|NCT00549172|E1|Reported Event|Operative (O)|"Partial resection of degenerative tear of medial meniscus~Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus"
1106353|NCT00549055|B1|Baseline|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
1106354|NCT00549055|P1|Participant Flow|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
1106355|NCT00549055|O1|Outcome|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
1106356|NCT00549055|O1|Outcome|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
1106357|NCT00549055|O1|Outcome|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
1106358|NCT00549055|O1|Outcome|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
1106359|NCT00549055|O1|Outcome|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
1106360|NCT00549055|O1|Outcome|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
1106361|NCT00549055|O1|Outcome|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
1106362|NCT00549055|E1|Reported Event|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
1106363|NCT00548886|B1|Baseline|Epinephrine|Healthy pediatric subjects will receive epinephrine. Epinephrine infusion will begin at 0.025 ug/kg/minute, for ten minutes.The epinephrine infusion will then be increased to 0.05 ug/kg/minute for five minutes. The epinephrine infusion will then be increased to a maximal dose of 0.1 ug/kg/minute for five minutes. The epinephrine infusion is then discontinued.
1106364|NCT00548886|P1|Participant Flow|Epinephrine|Healthy pediatric subjects will receive epinephrine. Epinephrine infusion will begin at 0.025 ug/kg/minute, for ten minutes.The epinephrine infusion will then be increased to 0.05 ug/kg/minute for five minutes. The epinephrine infusion will then be increased to a maximal dose of 0.1 ug/kg/minute for five minutes. The epinephrine infusion is then discontinued.
1106365|NCT00548886|O1|Outcome|Epinephrine|Healthy pediatric subjects will receive epinephrine. Epinephrine infusion will begin at 0.025 ug/kg/minute, for ten minutes.The epinephrine infusion will then be increased to 0.05 ug/kg/minute for five minutes. The epinephrine infusion will then be increased to a maximal dose of 0.1 ug/kg/minute for five minutes. The epinephrine infusion is then discontinued.
1106366|NCT00548886|E1|Reported Event|Epinephrine|Healthy pediatric subjects will receive epinephrine. Epinephrine infusion will begin at 0.025 ug/kg/minute, for ten minutes.The epinephrine infusion will then be increased to 0.05 ug/kg/minute for five minutes. The epinephrine infusion will then be increased to a maximal dose of 0.1 ug/kg/minute for five minutes. The epinephrine infusion is then discontinued.
1106367|NCT00548860|B3|Baseline|Total|Total of all reporting groups
1106368|NCT00548860|B2|Baseline|Standard Medical Care (SMC)|SMC for postpartum and heavy uterine bleeding subjects with anemia
1106369|NCT00548860|B1|Baseline|Ferric Carboxymaltose (FCM)|Intravenous (IV) iron
1106370|NCT00548860|P2|Participant Flow|Standard Medical Care (SMC)|SMC for postpartum and heavy uterine bleeding subjects with anemia
1106371|NCT00548860|P1|Participant Flow|Ferric Carboxymaltose (FCM)|Intravenous (IV) iron
1106372|NCT00548860|O2|Outcome|Standard Medical Care (SMC)|SMC for postpartum and heavy uterine bleeding subjects with anemia
1106373|NCT00548860|O1|Outcome|Ferric Carboxymaltose (FCM)|Intravenous (IV) iron
1106374|NCT00548860|E2|Reported Event|Standard Medical Care (SMC)|SMC for postpartum and heavy uterine bleeding subjects with anemia
1106375|NCT00548860|E1|Reported Event|Ferric Carboxymaltose (FCM)|Intravenous (IV) iron
1106376|NCT00548847|B1|Baseline|GM-CSF, Interferon-α-2b|GM-CSF, Interferon-α-2b: Dosing schedule: GM-CSF, 250 mcg/m2 Mon-Wed-Fri; Pegylated Interferon-α-2b 1.5 mcg/kg Monday weekly. Response assessed between 2 and 4 weeks. Duration on study is 3 months.
1106377|NCT00548847|P1|Participant Flow|GM-CSF, Interferon-α-2b|Granulocyte-macrophage colony-stimulating factor (GM-CSF), Interferon-α-2b: Dosing schedule: GM-CSF, 250 mcg/m2 Mon-Wed-Fri; Pegylated Interferon-α-2b 1.5 mcg/kg Monday weekly. Response assessed between 2 and 4 weeks. Duration on study is 3 months.
1106378|NCT00548847|O1|Outcome|GM-CSF, Interferon-α-2b|GM-CSF, Interferon-α-2b: Dosing schedule: GM-CSF, 250 mcg/m² Mon-Wed-Fri; Pegylated Interferon-α-2b 1.5 mcg/kg Monday weekly. Response assessed between 2 and 4 weeks. Duration on study is 3 months.
1106379|NCT00548847|O1|Outcome|GM-CSF, Interferon-α-2b|GM-CSF, Interferon-α-2b: Dosing schedule: GM-CSF, 250 mcg/m² Mon-Wed-Fri; Pegylated Interferon-α-2b 1.5 mcg/kg Monday weekly. Response assessed between 2 and 4 weeks. Duration on study is 3 months.
1106380|NCT00548847|E1|Reported Event|GM-CSF, Interferon-α-2b|GM-CSF, Interferon-α-2b: Dosing schedule: GM-CSF, 250 mcg/m2 Mon-Wed-Fri; Pegylated Interferon-α-2b 1.5 mcg/kg Monday weekly. Response assessed between 2 and 4 weeks. Duration on study is 3 months.
1106381|NCT00548808|B3|Baseline|Total|Total of all reporting groups
1106382|NCT00548808|B2|Baseline|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
1106383|NCT00548808|B1|Baseline|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
1106384|NCT00548808|P2|Participant Flow|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
1106385|NCT00548808|P1|Participant Flow|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
1106386|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
1106387|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
1106388|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
1106389|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
1106390|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
1106391|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
1106392|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
1106393|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
1106394|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
1106395|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
1106396|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
1106397|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
1106398|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
1106399|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
1106400|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
1106401|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
1106402|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
1106403|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
1106404|NCT00548808|E2|Reported Event|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
1106405|NCT00548808|E1|Reported Event|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
1106406|NCT00548717|B3|Baseline|Total|Total of all reporting groups
1106407|NCT00548717|B2|Baseline|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
1106408|NCT00548717|B1|Baseline|Siro/MMF|"Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);"
1106409|NCT00548717|P2|Participant Flow|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib for GVHD prophylaxis~Sirolimus (Rapamycin) Mycophenolate Mofetil (MMF) Bortezomib (Velcade)~*Bortezomib added when study reopened in November 2012"
1106410|NCT00548717|P1|Participant Flow|Siro/MMF|"Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis~Sirolimus (Rapamycin) Mycophenolate Mofetil (MMF)"
1106411|NCT00548717|O2|Outcome|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
1106412|NCT00548717|O1|Outcome|Siro/MMF|"Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);"
1106413|NCT00548717|O2|Outcome|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil,and Bortezomib as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
1106414|NCT00548717|O1|Outcome|Siro /MMF|"Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);"
1106415|NCT00548717|O2|Outcome|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
1106416|NCT00548717|O1|Outcome|Siro/MMF|"Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);"
1106417|NCT00548717|O2|Outcome|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
1106418|NCT00548717|O1|Outcome|Siro/MMF|Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);
1106419|NCT00548717|O2|Outcome|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
1106420|NCT00548717|O1|Outcome|Siro/MMF|Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);
1106421|NCT00548717|O2|Outcome|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
1106422|NCT00548717|O1|Outcome|Siro/MMF|Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);
1106423|NCT00548717|O2|Outcome|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);Bortezomib (Velcade) *added with study reopening in 2012"
1106424|NCT00548717|O1|Outcome|Siro/MMF|Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);
1106425|NCT00548717|E1|Reported Event|Siro/MMF (+/- Bortezomib)|"Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis (+/- Bortezomib)~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
1106427|NCT00548691|B2|Baseline|Standard Medical Care (SMC)|SMC for IDA (as determined by the Investigator) for treating CKD related anemia.
1106428|NCT00548691|B1|Baseline|Ferric Carboxymaltose (FCM)|Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer.
1106429|NCT00548691|P2|Participant Flow|Standard Medical Care (SMC)|SMC for IDA (as determined by the Investigator) for treating CKD related anemia.
1106430|NCT00548691|P1|Participant Flow|Ferric Carboxymaltose (FCM)|Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer.
1106431|NCT00548691|O2|Outcome|Standard Medical Care (SMC)|SMC for IDA (as determined by the Investigator) for treating CKD related anemia.
1106432|NCT00548691|O1|Outcome|Ferric Carboxymaltose (FCM)|Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer.
1106433|NCT00548691|E2|Reported Event|Standard Medical Care (SMC)|SMC for IDA (as determined by the Investigator) for treating CKD related anemia.
1106434|NCT00548691|E1|Reported Event|Ferric Carboxymaltose (FCM)|Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer.
1106435|NCT00548548|B3|Baseline|Total|Total of all reporting groups
1106436|NCT00548548|B2|Baseline|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
1106437|NCT00548548|B1|Baseline|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
1106438|NCT00548548|P2|Participant Flow|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
1106439|NCT00548548|P1|Participant Flow|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
1106482|NCT00548405|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
1106440|NCT00548548|O2|Outcome|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
1106441|NCT00548548|O1|Outcome|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
1106442|NCT00548548|O2|Outcome|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
1106443|NCT00548548|O1|Outcome|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
1106444|NCT00548548|O2|Outcome|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
1106445|NCT00548548|O1|Outcome|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
1106446|NCT00548548|O2|Outcome|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
1106503|NCT00548340|O3|Outcome|Placebo|Placebo: Placebo capsules, PO daily for five weeks
1106447|NCT00548548|O1|Outcome|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
1106448|NCT00548548|O2|Outcome|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
1106449|NCT00548548|O1|Outcome|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
1106450|NCT00548548|O2|Outcome|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
1106451|NCT00548548|O1|Outcome|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
1106452|NCT00548548|O2|Outcome|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
1106453|NCT00548548|O1|Outcome|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
1106454|NCT00548548|O2|Outcome|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
1106603|NCT00548249|E4|Reported Event|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106455|NCT00548548|O1|Outcome|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
1106456|NCT00548548|E2|Reported Event|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
1106457|NCT00548548|E1|Reported Event|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
1106458|NCT00548431|B1|Baseline|6-mercaptopurine|All patients received basic 6-mercaptopurine and in addition high-dose methotrexate(HDM) at 3 week intervals ((3 3-week intervals) in total) and PEG-asparaginase at 2 week intervals(5 dosis in total) . Patients received dose increments of 6-mercaptopurine 14 days after High-dose methotrexate if the myelotoxicity was acceptable
1106459|NCT00548431|P1|Participant Flow|6-mercaptopurine|All patients received basic 6-mercaptopurine and in addition high-dose methotrexate(HDM) at 3 week intervals ((3 3-week intervals) in total) and PEG-asparaginase at 2 week intervals(5 dosis in total) . Patients received dose increments of 6-mercaptopurine 14 days after High-dose methotrexate if the myelotoxicity was acceptable
1106460|NCT00548431|O1|Outcome|6-mercaptopurine|All patients received basic 6-mercaptopurine and in addition high-dose methotrexate(HDM) at 3 week intervals ((3 3-week intervals) in total) and PEG-asparaginase at 2 week intervals(5 dosis in total) . Patients received dose increments of 6-mercaptopurine 14 days after High-dose methotrexate if the myelotoxicity was acceptable
1106461|NCT00548431|E1|Reported Event|6-mercaptopurine|All patients received basic 6-mercaptopurine and in addition high-dose methotrexate(HDM) at 3 week intervals ((3 3-week intervals) in total) and PEG-asparaginase at 2 week intervals(5 dosis in total) . Patients received dose increments of 6-mercaptopurine 14 days after High-dose methotrexate if the myelotoxicity was acceptable
1106462|NCT00548418|B1|Baseline|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle~Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle~Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
1106504|NCT00548340|O2|Outcome|VEC-162 50 mg|VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks
1106463|NCT00548418|P1|Participant Flow|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle~Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle~Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
1106464|NCT00548418|O1|Outcome|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle~Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle~Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
1106465|NCT00548418|O1|Outcome|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle~Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle~Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
1106466|NCT00548418|O1|Outcome|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle~Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle~Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
1106467|NCT00548418|O1|Outcome|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle~Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle~Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
1106468|NCT00548418|O1|Outcome|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle~Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle~Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
1106469|NCT00548418|E1|Reported Event|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle~Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle~Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
1106470|NCT00548405|B4|Baseline|Total|Total of all reporting groups
1106471|NCT00548405|B3|Baseline|Alemtuzumab 24mg|Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion over 4 hours on 3 consecutive days at Month 12.
1106472|NCT00548405|B2|Baseline|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion over 4 hours on 3 consecutive days at Month 12.
1106473|NCT00548405|B1|Baseline|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
1106474|NCT00548405|P3|Participant Flow|Alemtuzumab 24mg|Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12.
1106475|NCT00548405|P2|Participant Flow|Alemtuzumab 12 mg|Alemtuzumab (Lemtrada™) 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
1106476|NCT00548405|P1|Participant Flow|Interferon Beta-1a|Interferon Beta-1a (Rebif®) 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
1106477|NCT00548405|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
1106478|NCT00548405|O1|Outcome|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
1106479|NCT00548405|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
1106480|NCT00548405|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
1106481|NCT00548405|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
1108647|NCT00542425|E2|Reported Event|BA058 20 µg|
1106483|NCT00548405|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
1106484|NCT00548405|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
1106485|NCT00548405|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
1106486|NCT00548405|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
1106487|NCT00548405|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
1106488|NCT00548405|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
1106489|NCT00548405|E4|Reported Event|Alemtuzumab (Pooled)|Included all participants who received alemtuzumab 12 mg or 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg or 24 mg per day IV infusion on 3 consecutive days at Month 12.
1106490|NCT00548405|E3|Reported Event|Alemtuzumab 24 mg|Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12.
1106491|NCT00548405|E2|Reported Event|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
1106492|NCT00548405|E1|Reported Event|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
1106493|NCT00548340|B4|Baseline|Total|Total of all reporting groups
1106494|NCT00548340|B3|Baseline|Placebo|Placebo: Placebo capsules, PO daily for five weeks
1106495|NCT00548340|B2|Baseline|VEC-162 50 mg|VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks
1106496|NCT00548340|B1|Baseline|VEC-162 20 mg|VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks
1106497|NCT00548340|P3|Participant Flow|Placebo|Placebo: Placebo capsules, PO daily for five weeks
1106498|NCT00548340|P2|Participant Flow|VEC-162 50 mg|VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks
1106499|NCT00548340|P1|Participant Flow|VEC-162 20 mg|VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks
1106500|NCT00548340|O3|Outcome|Placebo|Placebo: Placebo capsules, PO daily for five weeks
1106501|NCT00548340|O2|Outcome|VEC-162 50 mg|VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks
1106505|NCT00548340|O1|Outcome|VEC-162 20 mg|VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks
1106506|NCT00548340|O3|Outcome|Placebo|Placebo: Placebo capsules, PO daily for five weeks
1106507|NCT00548340|O2|Outcome|VEC-162 50 mg|VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks
1106508|NCT00548340|O1|Outcome|VEC-162 20 mg|VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks
1106509|NCT00548340|O3|Outcome|Placebo|Placebo: Placebo capsules, PO daily for five weeks
1106510|NCT00548340|O2|Outcome|VEC-162 50 mg|VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks
1106511|NCT00548340|O1|Outcome|VEC-162 20 mg|VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks
1106512|NCT00548340|E3|Reported Event|Placebo|Placebo: Placebo capsules, PO daily for five weeks
1106513|NCT00548340|E2|Reported Event|VEC-162 50 mg|VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks
1106514|NCT00548340|E1|Reported Event|VEC-162 20 mg|VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks
1106515|NCT00548327|B3|Baseline|Total|Total of all reporting groups
1106516|NCT00548327|B2|Baseline|Patients With Schizophrenia|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in patients with schizophrenia. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
1106517|NCT00548327|B1|Baseline|Healthy Participants|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in healthy volunteers. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
1106518|NCT00548327|P2|Participant Flow|Patients With Schizophrenia|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in patients with schizophrenia. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
1106519|NCT00548327|P1|Participant Flow|Healthy Participants|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in healthy volunteers. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
1106520|NCT00548327|O2|Outcome|Patients With Schizophrenia|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in patients with schizophrenia. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
1106521|NCT00548327|O1|Outcome|Healthy Participants|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in healthy volunteers. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
1106522|NCT00548327|O2|Outcome|Patients With Schizophrenia|
1106523|NCT00548327|O1|Outcome|Healthy Participants|Atomoxetine 40 mg twice daily (bid), placebo, Val/Val, Val/Met, Met/Met.
1106524|NCT00548327|O2|Outcome|Patients With Schizophrenia|
1106525|NCT00548327|O1|Outcome|Healthy Participants|Atomoxetine 40 mg twice daily (bid), placebo, Val/Val, Val/Met, Met/Met.
1106526|NCT00548327|O2|Outcome|Patients With Schizophrenia|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in patients with schizophrenia. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
1106527|NCT00548327|O1|Outcome|Healthy Participants|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in healthy volunteers. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
1106528|NCT00548327|O2|Outcome|Patients With Schizophrenia|
1106529|NCT00548327|O1|Outcome|Healthy Participants|
1106574|NCT00548249|O3|Outcome|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106575|NCT00548249|O2|Outcome|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106942|NCT00546871|O6|Outcome|Total SC (Parts 2, 3a, 3b, Extension)|
1106530|NCT00548327|O2|Outcome|Patients With Schizophrenia|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in patients with schizophrenia. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
1106531|NCT00548327|O1|Outcome|Healthy Participants|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in healthy volunteers. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
1106532|NCT00548327|E4|Reported Event|Placebo-Healthy Volunteer|
1106533|NCT00548327|E3|Reported Event|Atomoxetine-Healthy Volunteer|
1106534|NCT00548327|E2|Reported Event|Placebo-Patient|
1106535|NCT00548327|E1|Reported Event|Atomoxetine-Patient|
1106536|NCT00548262|B1|Baseline|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
1106537|NCT00548262|P1|Participant Flow|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
1106538|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
1106539|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
1106540|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
1106541|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
1106542|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
1106543|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
1106544|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
1106545|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
1106546|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
1106547|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
1106548|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
1106576|NCT00548249|O1|Outcome|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106943|NCT00546871|O5|Outcome|Study Extension, SC Administration|
1106549|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
1106550|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
1106551|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
1106552|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
1106553|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
1106554|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
1106555|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
1106556|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
1106557|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
1106558|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
1106604|NCT00548249|E3|Reported Event|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106559|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
1106560|NCT00548262|E1|Reported Event|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
1106561|NCT00548249|B6|Baseline|Total|Total of all reporting groups
1106562|NCT00548249|B5|Baseline|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106563|NCT00548249|B4|Baseline|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106564|NCT00548249|B3|Baseline|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106565|NCT00548249|B2|Baseline|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106566|NCT00548249|B1|Baseline|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106567|NCT00548249|P5|Participant Flow|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106568|NCT00548249|P4|Participant Flow|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106569|NCT00548249|P3|Participant Flow|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106570|NCT00548249|P2|Participant Flow|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106571|NCT00548249|P1|Participant Flow|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106572|NCT00548249|O5|Outcome|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106573|NCT00548249|O4|Outcome|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106649|NCT00547911|O3|Outcome|LDOPS + ENT|Orally received 400 mg of droxidopa after 200 mg of entacapone
1106577|NCT00548249|O5|Outcome|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106578|NCT00548249|O4|Outcome|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106579|NCT00548249|O3|Outcome|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106580|NCT00548249|O2|Outcome|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106581|NCT00548249|O1|Outcome|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106582|NCT00548249|O5|Outcome|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106583|NCT00548249|O4|Outcome|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106584|NCT00548249|O3|Outcome|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106585|NCT00548249|O2|Outcome|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106586|NCT00548249|O1|Outcome|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106587|NCT00548249|O5|Outcome|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106588|NCT00548249|O4|Outcome|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106589|NCT00548249|O3|Outcome|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106590|NCT00548249|O2|Outcome|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106591|NCT00548249|O1|Outcome|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106592|NCT00548249|O5|Outcome|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106593|NCT00548249|O4|Outcome|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106594|NCT00548249|O3|Outcome|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106595|NCT00548249|O2|Outcome|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106596|NCT00548249|O1|Outcome|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106597|NCT00548249|O5|Outcome|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106598|NCT00548249|O4|Outcome|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106599|NCT00548249|O3|Outcome|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106600|NCT00548249|O2|Outcome|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106601|NCT00548249|O1|Outcome|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106602|NCT00548249|E5|Reported Event|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106605|NCT00548249|E2|Reported Event|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106606|NCT00548249|E1|Reported Event|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
1106607|NCT00548184|B1|Baseline|Lapatinib + Trastuzumab|All study participants received lapatinib 1000mg daily and trastuzumab 4mg/kg loading dose and then 2mg/kg every week
1106608|NCT00548184|P1|Participant Flow|Lapatinib + Trastuzumab|All study participants received lapatinib 1000mg daily and Trastuzumab 4mg/kg loading dose and then 2mg/kg every week
1106609|NCT00548184|O1|Outcome|Lapatinib + Trastuzumab|All study participants received lapatinib 1000mg daily and trauzumab 4mg/kg loading dose and then 2mg/kg every week
1106610|NCT00548184|E1|Reported Event|Lapatinib + Trastuzumab|All study participants received lapatinib 1000mg daily and trastuzumab 4mg/kg loading dose and then 2mg/kg every week
1106611|NCT00548145|B3|Baseline|Total|Total of all reporting groups
1106612|NCT00548145|B2|Baseline|Cholesterol-lowering Medicine Other Than Statin|duration: 12 months
1106613|NCT00548145|B1|Baseline|Pitavastatin|2 mg by orally/day Duration: 12 months
1106614|NCT00548145|P2|Participant Flow|Cholesterol-lowering Medicine Other Than Statin|duration: 12 months
1106615|NCT00548145|P1|Participant Flow|Pitavastatin|2 mg by orally/day Duration: 12 months
1106616|NCT00548145|O2|Outcome|Cholesterol-lowering Medicine Other Than Statin|duration: 12 months
1106617|NCT00548145|O1|Outcome|Pitavastatin|2 mg by orally/day Duration: 12 months
1106618|NCT00548145|E2|Reported Event|Cholesterol-lowering Medicine Other Than Statin|duration: 12 months
1106619|NCT00548145|E1|Reported Event|Pitavastatin|2 mg by orally/day Duration: 12 months
1106620|NCT00548132|B3|Baseline|Total|Total of all reporting groups
1106621|NCT00548132|B2|Baseline|Chlorhexidine-impregnated Foam Dressing|Patients in this group had the Biopatch applied on the catheter exit site after insertion of the catheter. Dressings were changed every 7 days along with the Biopatch after the skin was cleaned with a chlorhexidine-alcohol antiseptic solution. Dressings were assessed daily and changed if they were soiled, non-intact, or bloody before the 7-day period was up.
1106622|NCT00548132|B1|Baseline|Standard of Care|Patients in this arm will continue to get the standard catheter care protocol without the use of the chlorhexidine-impregnated foam dressing.
1106623|NCT00548132|P2|Participant Flow|Chlorhexidine-impregnated Foam Dressing|
1106624|NCT00548132|P1|Participant Flow|Standard of Care|Patients in this arm will continue to get the standard catheter care protocol without the use of the chlorhexidine-impregnated foam dressing.
1106650|NCT00547911|O2|Outcome|LDOPS + CAR|Orally received 400 mg of droxidopa after 200 mg of carbidopa
1106651|NCT00547911|O1|Outcome|LDOPS + Placebo|Orally received 400 mg of droxidopa after 200 mg of placebo
1106625|NCT00548132|O2|Outcome|Intervention Group|Patients in this group had the Biopatch applied on the catheter exit site after insertion of the catheter. Dressings were changed every 7 days along with the Biopatch after the skin was cleaned with a chlorhexidine-alcohol antiseptic solution. Dressings were assessed daily and changed if they were soiled, non-intact, or bloody before the 7-day period was up.
1106626|NCT00548132|O1|Outcome|Standard of Care|Standard catheter care-use of chlorhexidine-alcohol solution to prep the catheter site and then a bioocclusive dressing is applied
1106627|NCT00548132|O2|Outcome|Chlorhexidine Impregnated Sponge|Patients in this group had the Biopatch applied on the catheter exit site after insertion of the catheter. Dressings were changed every 7 days along with the Biopatch after the skin was cleaned with a chlorhexidine-alcohol antiseptic solution. Dressings were assessed daily and changed if they were soiled, non-intact, or bloody before the 7-day period was up.
1106628|NCT00548132|O1|Outcome|Standard of Care|Standard of care
1106629|NCT00548132|E2|Reported Event|Chlorhexidine-impregnated Foam Dressing|
1106630|NCT00548132|E1|Reported Event|Standard of Care|Patients in this arm will continue to get the standard catheter care protocol without the use of the chlorhexidine-impregnated foam dressing.
1106631|NCT00548041|B1|Baseline|Subjects Undergoing Rapid HIV Testing in the ED|Subjects were seen in the ED and had rapid HIV testing performed.
1106632|NCT00548041|P1|Participant Flow|Subjects Undergoing Rapid HIV Testing in the ED|Subjects were seen in the ED and had rapid HIV testing performed.
1106633|NCT00548041|O1|Outcome|Subjects Undergoing Rapid HIV Testing in the ED|Subjects were seen in the ED and had rapid HIV testing performed.
1106634|NCT00548041|E1|Reported Event|Subjects Undergoing HIV Testing in the ED|
1106635|NCT00547911|B5|Baseline|Total|Total of all reporting groups
1106636|NCT00547911|B4|Baseline|Parkinson's Disease|Subjects with autonomic failure and a history of Parkinson's Disease
1106637|NCT00547911|B3|Baseline|Multiple System Atrophy|Subjects with autonomic failure and a history of Multiple System Atrophy
1106638|NCT00547911|B2|Baseline|Pure Autonomic Failure|Subjects with Pure Autonomic Failure
1106639|NCT00547911|B1|Baseline|Healthy Volunteer|Subjects in good general health
1106640|NCT00547911|P6|Participant Flow|LDOPS + ENT; LDOPS + CAR; LDOPS + Placebo|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + ENT, followed by LDOPS + CAR, and lastly LDOPS + Placebo.
1106641|NCT00547911|P5|Participant Flow|LDOPS + ENT; LDOPS + Placebo; LDOPS + CAR|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + ENT, followed by LDOPS + Placebo, and lastly LDOPS + CAR.
1106724|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
1106642|NCT00547911|P4|Participant Flow|LDOPS + CAR; LDOPS + ENT; LDOPS + Placebo|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + CAR, followed by LDOPS + ENT, and lastly LDOPS + Placebo.
1106643|NCT00547911|P3|Participant Flow|LDOPS + CAR; LDOPS + Placebo; LDOPS + ENT|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + CAR, followed by LDOPS + Placebo, and lastly LDOPS + ENT.
1106644|NCT00547911|P2|Participant Flow|LDOPS + Placebo; LDOPS + Ent; LDOPS + CAR|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + Placebo, followed by LDOPS + ENT, and lastly LDOPS + CAR.
1106645|NCT00547911|P1|Participant Flow|LDOPS + Placebo; LDOPS + CAR; LDOPS + ENT|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + Placebo, followed by LDOPS + CAR, and lastly LDOPS + ENT.
1106646|NCT00547911|O3|Outcome|LDOPS + ENT|Orally received 400 mg of droxidopa after 200 mg of entacapone
1106647|NCT00547911|O2|Outcome|LDOPS + CAR|Orally received 400 mg of droxidopa after 200 mg of carbidopa
1106648|NCT00547911|O1|Outcome|LDOPS + Placebo|Orally received 400 mg of droxidopa after 200 mg of placebo
1106944|NCT00546871|O4|Outcome|Study Part 3b, SC Administration|
1106652|NCT00547911|O3|Outcome|LDOPS + ENT|Orally received 400 mg of droxidopa after 200 mg of entacapone
1106653|NCT00547911|O2|Outcome|LDOPS + CAR|Orally received 400 mg of droxidopa after 200 mg of carbidopa
1106654|NCT00547911|O1|Outcome|LDOPS + Placebo|Orally received 400 mg of droxidopa after 200 mg of placebo
1106655|NCT00547911|O3|Outcome|LDOPS + ENT|Orally received 400 mg of droxidopa after 200 mg of entacapone
1106656|NCT00547911|O2|Outcome|LDOPS + CAR|Orally received 400 mg of droxidopa after 200 mg of placebo
1106657|NCT00547911|O1|Outcome|LDOPS + Placebo|Orally received 400 mg of droxidopa after 200 mg of placebo
1106658|NCT00547911|O3|Outcome|LDOPS + ENT|Orally received 400 mg of droxidopa after 200 mg of entacapone
1106659|NCT00547911|O2|Outcome|LDOPS + CAR|Orally received 400 mg of droxidopa after 200 mg of carbidopa
1106660|NCT00547911|O1|Outcome|LDOPS + Placebo|Orally received 400 mg of droxidopa after 200 mg of placebo
1106661|NCT00547911|O3|Outcome|LDOPS + ENT|Orally received 400 mg of droxidopa after 200 mg of carbidopa
1106662|NCT00547911|O2|Outcome|LDOPS + CAR|Orally received 400 mg of droxidopa after 200 mg of carbidopa
1106663|NCT00547911|O1|Outcome|LDOPS + Placebo|Orally received 400 mg of droxidopa after 200 mg of placebo
1106664|NCT00547911|O3|Outcome|LDOPS + ENT|Orally received 400 mg of droxidopa after 200 mg of entacapone
1106665|NCT00547911|O2|Outcome|LDOPS + CAR|Orally received 400 mg of droxidopa after 200 mg of carbidopa
1106666|NCT00547911|O1|Outcome|LDOPS + Placebo|Orally received 400 mg of droxidopa after 200 mg of placebo
1106667|NCT00547911|E6|Reported Event|LDOPS + ENT; LDOPS + CAR; LDOPS + Placebo|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + ENT, followed by LDOPS + CAR, and lastly LDOPS + Placebo.
1106668|NCT00547911|E5|Reported Event|LDOPS + ENT; LDOPS + Placebo; LDOPS + CAR|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + ENT, followed by LDOPS + Placebo, and lastly LDOPS + CAR.
1106669|NCT00547911|E4|Reported Event|LDOPS + CAR; LDOPS + ENT; LDOPS + Placebo|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + CAR, followed by LDOPS + ENT, and lastly LDOPS + Placebo.
1106837|NCT00546910|E1|Reported Event|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
1106838|NCT00546897|B3|Baseline|Total|Total of all reporting groups
1106670|NCT00547911|E3|Reported Event|LDOPS + CAR; LDOPS + Placebo; LDOPS + ENT|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + CAR, followed by LDOPS + Placebo, and lastly LDOPS + ENT.
1106671|NCT00547911|E2|Reported Event|LDOPS + Placebo; LDOPS + Ent; LDOPS + CAR|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + Placebo, followed by LDOPS + ENT, and lastly LDOPS + CAR.
1106672|NCT00547911|E1|Reported Event|LDOPS + Placebo; LDOPS + CAR; LDOPS + ENT|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + Placebo, followed by LDOPS + CAR, and lastly LDOPS + ENT.
1106673|NCT00547703|B3|Baseline|Total|Total of all reporting groups
1106674|NCT00547703|B2|Baseline|Placebo|Patients in this group will receive an identical placebo capsule at night for 8 weeks.
1106675|NCT00547703|B1|Baseline|Nortriptyline|Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.
1106676|NCT00547703|P2|Participant Flow|Placebo|Patients in this group will receive an identical placebo capsule at night for 8 weeks.
1106677|NCT00547703|P1|Participant Flow|Nortriptyline|Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.
1106678|NCT00547703|O2|Outcome|Placebo|Patients in this group will receive an identical placebo capsule at night for 8 weeks.
1106679|NCT00547703|O1|Outcome|Nortriptyline|Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.
1106680|NCT00547703|E2|Reported Event|Placebo|Patients in this group will receive an identical placebo capsule at night for 8 weeks.
1106681|NCT00547703|E1|Reported Event|Nortriptyline|Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.
1106682|NCT00547638|B3|Baseline|Total|Total of all reporting groups
1106683|NCT00547638|B2|Baseline|Dermabond HVD|DERMABOND HVD: Comparator Tissue Adhesive for Topical Application
1106684|NCT00547638|B1|Baseline|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo) Tissue adhesive for Topical Application
1106685|NCT00547638|P2|Participant Flow|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
1106686|NCT00547638|P1|Participant Flow|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
1106687|NCT00547638|O2|Outcome|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
1106688|NCT00547638|O1|Outcome|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
1106689|NCT00547638|O2|Outcome|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
1106690|NCT00547638|O1|Outcome|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
1106691|NCT00547638|O2|Outcome|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
1106692|NCT00547638|O1|Outcome|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
1106693|NCT00547638|O2|Outcome|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
1106694|NCT00547638|O1|Outcome|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
1106695|NCT00547638|O2|Outcome|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
1106696|NCT00547638|O1|Outcome|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
1106697|NCT00547638|O2|Outcome|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
1106698|NCT00547638|O1|Outcome|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
1106699|NCT00547638|E2|Reported Event|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
1106700|NCT00547638|E1|Reported Event|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
1106701|NCT00547534|B1|Baseline|Lymphoma Subjects|Subjects that met all eligibility criteria and were given study treatment.
1106702|NCT00547534|P1|Participant Flow|Lymphoma Subjects|Subjects that met all eligibility criteria and were given study treatment.
1106703|NCT00547534|O1|Outcome|Lymphoma Subjects|Subjects that met all eligibility criteria and were treated.
1106704|NCT00547534|O1|Outcome|Lymphoma Subjects|Subjects that met all eligibility criteria and were treated
1106705|NCT00547534|O1|Outcome|Lymphoma Subjects|Subjects that met all eligibility criteria and were treated.
1106706|NCT00547534|E1|Reported Event|Lymphoma Subjects|Subjects that met all eligibility criteria and were given study treatment.
1106707|NCT00547521|B3|Baseline|Total|Total of all reporting groups
1106708|NCT00547521|B2|Baseline|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
1106709|NCT00547521|B1|Baseline|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
1107204|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
1106710|NCT00547521|P2|Participant Flow|SC Abatacept Cohort|In the ST period, participants in this cohort were administered monotherapy, a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening ie, MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept. During the LTE, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE period, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition. LTE period pooled all participants into 1 arm. Participation in the LTE continued until the abatacept SC formulation was commercially available in the country or until the study was terminated by the sponsor.
1106711|NCT00547521|P1|Participant Flow|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
1106712|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
1106713|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
1106714|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
1106731|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly. Participants did not receive MTX at screening ie, MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept. During LTE period, all eligible participants continued to self administer abatacept (125 mg SC) on a weekly basis.
1106715|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
1106716|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
1106717|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
1106718|NCT00547521|O1|Outcome|Abatacept Monotherapy Subgroup|Abatacept Monotherapy Subgroup was defined as those participants who received as at least 1 dose of abatacept and did not receive MTX in the ST and LTE Studies.
1106719|NCT00547521|O1|Outcome|Abatacept Monotherapy Subgroup|Abatacept Monotherapy Subgroup was defined as those participants who received as at least 1 dose of abatacept and did not receive MTX in the ST and LTE Studies.
1106720|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
1106721|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
1106722|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
1106723|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
1106895|NCT00546871|O1|Outcome|Infusion Rate Change (Percentage) - For Any Reason|Infusion Rate Reduced and/or Infusion Interrupted or Stopped. Percentage of Infusions with a change in the infusion rate.
1107205|NCT00546572|O2|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
1106725|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
1106726|NCT00547521|O1|Outcome|Abatacept Long Term Extension (LTE) Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition. Participation in the LTE continued until the abatacept SC formulation was commercially available in the country or until the study was terminated by the sponsor.
1106727|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
1106728|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
1106729|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
1106730|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
1106752|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
1106732|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept. During LTE period, adjustments to MTX were permitted at the investigator’s discretion based upon the participant’s clinical status.
1106733|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
1106734|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
1106735|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
1106736|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
1106737|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
1106738|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
1106739|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
1106740|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
1106741|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly. Participants did not receive MTX at screening ie, MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept. During LTE period, all eligible participants continued to self administer abatacept (125 mg SC) on a weekly basis.
1106742|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept. During LTE period, adjustments to MTX were permitted at the investigator’s discretion based upon the participant’s clinical status.
1106743|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
1106744|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
1106745|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
1106746|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
1106747|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
1106748|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
1106749|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
1106750|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
1106751|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
1106805|NCT00547157|O1|Outcome|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
1106806|NCT00547157|E2|Reported Event|Chemotherapy Plus Radiotherapy|
1106753|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
1106754|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
1106755|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
1106756|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
1106757|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
1106758|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
1106759|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
1106760|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
1106761|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
1106762|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
1106763|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
1106764|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
1108648|NCT00542425|E1|Reported Event|Placebo|
1106765|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
1106766|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
1106767|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
1106768|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
1106769|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
1106770|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
1106771|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
1106772|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
1106773|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
1106774|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
1106775|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
1106776|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
1106777|NCT00547521|E3|Reported Event|Long Term Extension (LTE):125 mg SC Abatacept|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator's discretion based upon the participant's clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant's clinical condition.
1106778|NCT00547521|E2|Reported Event|Short Term Study: SC Abatacept Monotherapy|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
1106779|NCT00547521|E1|Reported Event|Short Term Study: Subcutaneous (SC) Abatacept + Methotrexate|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
1106780|NCT00547456|B1|Baseline|Decrease in Oxygen Level When Sleeping|"Patients are their own controls and tested pre and post the addition of night time supplemental oxygen~Oxygen: Oxygen 2-3L Nasal cannula"
1106781|NCT00547456|P1|Participant Flow|Decrease in Oxygen Level When Sleeping|"Patients are their own controls and tested pre and post the addition of night time supplemental oxygen~Oxygen: Oxygen 2-3L Nasal cannula"
1106782|NCT00547456|O1|Outcome|Decrease in Oxygen Level When Sleeping|"Patients are their own controls and tested pre and post the addition of night time supplemental oxygen~Oxygen: Oxygen 2-3L Nasal cannula"
1106783|NCT00547456|E1|Reported Event|Decrease in Oxygen Level When Sleeping|"Patients are their own controls and tested pre and post the addition of night time supplemental oxygen~Oxygen: Oxygen 2-3L Nasal cannula"
1106784|NCT00547365|B1|Baseline|Human Immune Globulin Intravenous (IGIV)|
1106785|NCT00547365|P1|Participant Flow|Human Immune Globulin Intravenous (IGIV)|The therapeutic potential of human immune globulin intravenous (IGIV)was evaluated in patients with cardiac-associated AL amyloidosis. Patients received, via intravenous infusion, 30-40 gm of IGIV (depending on body weight) weekly for 3 months and then every other week for the next 9 months.The total time to complete the study was ~1 yr.
1106786|NCT00547365|O1|Outcome|Human Immune Globulin Intravenous (IGIV)|Human immune globulin intravenous (IGIV) was infused into 10 patients with cardiac-associated AL amyloidosis and its therapeutic potential evaluated through measurement of serum anti-fibril IgG antibody levels, as well as amyloid burden, pre- and post-administration.
1106896|NCT00546871|O2|Outcome|Infusion Rate Change - For Tolerability/AE|Infusion Rate Reduced and/or Infusion Interrupted or Stopped
1108649|NCT00542386|B7|Baseline|Total|Total of all reporting groups
1106787|NCT00547365|O1|Outcome|Human Immune Globulin Intravenous (IGIV)|Immune globulin intravenous (IGIV) was administered to patients with cardiac-dominant AL amyloidosis in order to determine its therapeutic potential or possible toxicity when given to subjects weekly for 3 months and then every other week for the next 9 months. Response was evaluated by changes in serum anti-fibril antibody levels, changes in BNP (B-type natriuretic peptide) levels and IVS (interventricular septum) thickness.
1106788|NCT00547365|E1|Reported Event|Human Immune Globulin Intravenous (IGIV)|Therapeutic potential of human immune globulin intravenous (IGIV)in patients with cardiac-associated AL amyloidosis
1106789|NCT00547157|B3|Baseline|Total|Total of all reporting groups
1106790|NCT00547157|B2|Baseline|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
1106791|NCT00547157|B1|Baseline|Panitumumab Plus Radiotherpy|Consists of Panitumumab and Radiotherpy
1106792|NCT00547157|P2|Participant Flow|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
1106793|NCT00547157|P1|Participant Flow|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
1106794|NCT00547157|O2|Outcome|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
1106795|NCT00547157|O1|Outcome|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
1106796|NCT00547157|O2|Outcome|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
1106797|NCT00547157|O1|Outcome|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
1106798|NCT00547157|O2|Outcome|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
1106799|NCT00547157|O1|Outcome|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
1106800|NCT00547157|O2|Outcome|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
1106801|NCT00547157|O1|Outcome|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
1106802|NCT00547157|O2|Outcome|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
1106803|NCT00547157|O1|Outcome|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
1106804|NCT00547157|O2|Outcome|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
1106945|NCT00546871|O3|Outcome|Study Part 3a, SC Administration|
1106807|NCT00547157|E1|Reported Event|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
1106808|NCT00547118|B3|Baseline|Total|Total of all reporting groups
1106809|NCT00547118|B2|Baseline|Placebo|"Placebo~Placebo: Placebo"
1106810|NCT00547118|B1|Baseline|Rimonabant|"Rimonabant~Rimonabant: Rimonabant, 1 20 mg tablet given 1 time per day for 112 days."
1106811|NCT00547118|P2|Participant Flow|Placebo|"Placebo~Placebo: Placebo"
1106812|NCT00547118|P1|Participant Flow|Rimonabant|Rimonabant: Rimonabant, 1 20 mg tablet given 1 time per day for 112 days.
1106813|NCT00547118|O2|Outcome|Placebo|"Placebo~Placebo: Placebo"
1106814|NCT00547118|O1|Outcome|Rimonabant|Rimonabant: Rimonabant, 1 20 mg tablet given 1 time per day for 112 days.
1106815|NCT00547118|E2|Reported Event|Placebo|"Placebo~Placebo: Placebo"
1106816|NCT00547118|E1|Reported Event|Rimonabant|Rimonabant: Rimonabant, 1 20 mg tablet given 1 time per day for 112 days.
1106817|NCT00546910|B3|Baseline|Total|Total of all reporting groups
1106818|NCT00546910|B2|Baseline|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
1106819|NCT00546910|B1|Baseline|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
1106820|NCT00546910|P2|Participant Flow|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
1106821|NCT00546910|P1|Participant Flow|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
1106822|NCT00546910|O2|Outcome|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
1106823|NCT00546910|O1|Outcome|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
1106824|NCT00546910|O2|Outcome|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
1106825|NCT00546910|O1|Outcome|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
1106826|NCT00546910|O2|Outcome|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
1106827|NCT00546910|O1|Outcome|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
1106828|NCT00546910|O2|Outcome|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
1106829|NCT00546910|O1|Outcome|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
1106830|NCT00546910|O2|Outcome|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
1106831|NCT00546910|O1|Outcome|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
1106832|NCT00546910|O2|Outcome|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
1106833|NCT00546910|O1|Outcome|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
1106834|NCT00546910|O2|Outcome|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
1106835|NCT00546910|O1|Outcome|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
1106836|NCT00546910|E2|Reported Event|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
1106839|NCT00546897|B2|Baseline|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
1106840|NCT00546897|B1|Baseline|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
1106841|NCT00546897|P2|Participant Flow|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
1106842|NCT00546897|P1|Participant Flow|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
1106881|NCT00546884|P1|Participant Flow|Minimal Intervention|"The MI condition will expose participants to the provision of an advance directive and written instructions, roughly mimicking community standards and the requirements of the federal Patient Self Determination Act.~MI condition: Individuals randomized to this condition will be provided with written end of life educational materials an advance directive form, along with instructions to complete it."
1106882|NCT00546884|O2|Outcome|Guided Intervention|"Subjects randomized to the GI group will be invited to meet individually with a health care professional specializing in EOL care~GI: The GI condition will expose participants to education, guidance and counseling, and an advance directive tool."
1106843|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
1106844|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
1106845|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
1106846|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
1106847|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
1106848|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
1106849|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
1106850|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
1106851|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
1106852|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
1106853|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
1106854|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
1106855|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
1106856|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
1106857|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
1106858|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
1106859|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
1106860|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
1106861|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
1106862|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
1106863|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
1106864|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
1106865|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
1106866|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
1106867|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
1106868|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
1106869|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
1106870|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
1106871|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
1106872|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
1106873|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
1106874|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
1106875|NCT00546897|E2|Reported Event|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
1106876|NCT00546897|E1|Reported Event|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
1106877|NCT00546884|B3|Baseline|Total|Total of all reporting groups
1106878|NCT00546884|B2|Baseline|Guided Intervention|"Subjects randomized to the GI group will be invited to meet individually with a health care professional specializing in EOL care~GI: The GI condition will expose participants to education, guidance and counseling, and an advance directive tool."
1106879|NCT00546884|B1|Baseline|Minimal Intervention|"The MI condition will expose participants to the provision of an advance directive and written instructions, roughly mimicking community standards and the requirements of the federal Patient Self Determination Act.~MI condition: Individuals randomized to this condition will be provided with written end of life educational materials an advance directive form, along with instructions to complete it."
1106880|NCT00546884|P2|Participant Flow|Guided Intervention|"Subjects randomized to the GI group will be invited to meet individually with a health care professional specializing in EOL care~GI: The GI condition will expose participants to education, guidance and counseling, and an advance directive tool."
1106925|NCT00546871|O5|Outcome|Study Extension, SC Administration|
1106883|NCT00546884|O1|Outcome|Minimal Intervention|"The MI condition will expose participants to the provision of an advance directive and written instructions, roughly mimicking community standards and the requirements of the federal Patient Self Determination Act.~MI condition: Individuals randomized to this condition will be provided with written end of life educational materials an advance directive form, along with instructions to complete it."
1106884|NCT00546884|E2|Reported Event|Guided Intervention|"Subjects randomized to the GI group will be invited to meet individually with a health care professional specializing in EOL care~GI: The GI condition will expose participants to education, guidance and counseling, and an advance directive tool."
1106885|NCT00546884|E1|Reported Event|Minimal Intervention|"The MI condition will expose participants to the provision of an advance directive and written instructions, roughly mimicking community standards and the requirements of the federal Patient Self Determination Act.~MI condition: Individuals randomized to this condition will be provided with written end of life educational materials an advance directive form, along with instructions to complete it."
1106886|NCT00546871|B1|Baseline|Treated Participants|
1106887|NCT00546871|P2|Participant Flow|12 Years and Older|"Part 1: IV infusions of IGIV, 10% (every 3 or 4 weeks) for 12 weeks at dose/schedule prior to study (300 - 1,000 mg/kg/4 weeks). Pharmacokinetic (PK) done on ≥12 years after 3rd or 4th infusion Part 2: Weekly subcutaneous (SC) IGIV, 10% at 130% of weekly equivalent dose in Part 1 for ≥12 weeks, until 15 subjects ≥ 12years completed PK assessment. PK determined Adjusted Dose in Part 3a Part 3a: 6 weeks SC IGIV Adjusted Dose. Trough levels determined at Week 5 to see if increase in trough levels was not within 15% of expected increase, then dose was individually adapted~Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was determined as follows:~If trough levels within 15% of expected over trough level determined in Part 1, dosing remained same as Part 3a~If trough levels not within 15% of expected over trough level in Part 1, participants received Individually Adapted Dose Study Extension: Participants were offered to enter into Extension"
1106888|NCT00546871|P1|Participant Flow|2 to <12 Years|"Part 1: IV infusions of IGIV, 10% (every 3 or 4 weeks) for 12 weeks at dose/schedule prior to study (300 - 1,000 mg/kg/4 weeks). Pharmacokinetic (PK) done on ≥12 years after 3rd or 4th infusion Part 2: Weekly subcutaneous (SC) IGIV, 10% at 130% of weekly equivalent dose in Part 1 for ≥12 weeks, until 15 subjects ≥ 12years completed PK assessment. PK determined Adjusted Dose in Part 3a Part 3a: 6 weeks SC IGIV Adjusted Dose. Trough levels determined at Week 5 to see if increase in trough levels was not within 15% of expected increase, then dose was individually adapted~Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was determined as follows:~If trough levels within 15% of expected over trough level determined in Part 1, dosing remained same as Part 3a~If trough levels not within 15% of expected over trough level in Part 1, participants received Individually Adapted Dose Study Extension: Participants were offered to enter into Extension"
1106889|NCT00546871|O3|Outcome|SESC|Dataset of participants with prior experience with subcutaneous administration of immunoglobulins
1106890|NCT00546871|O2|Outcome|SNSC|Dataset of participants naïve to SC administration of immunoglobulins
1106891|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
1106892|NCT00546871|O2|Outcome|Infusion Rate Change - For Tolerability/AE|Infusion Rate Reduced and/or Infusion Interrupted or Stopped
1106893|NCT00546871|O1|Outcome|Infusion Rate Change (Percentage) - For Any Reason|Infusion Rate Reduced and/or Infusion Interrupted or Stopped. Percentage of Infusions with a change in the infusion rate.
1106894|NCT00546871|O2|Outcome|Infusion Rate Change - For Tolerability/AE|Infusion Rate Reduced and/or Infusion Interrupted or Stopped
1106968|NCT00546871|O2|Outcome|Infusion Rate Change - For Tolerability/AE|Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs
1106897|NCT00546871|O1|Outcome|Infusion Rate Change (Percentage) - For Any Reason|Infusion Rate Reduced and/or Infusion Interrupted or Stopped. Percentage of Infusions with a change in the infusion rate.
1106898|NCT00546871|O2|Outcome|Infusion Rate Change - For Tolerability/AE|Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs
1106899|NCT00546871|O1|Outcome|Infusion Rate Change - For Any Reason|Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Any Reason
1106900|NCT00546871|O3|Outcome|SESC|Dataset of participants with prior experience with subcutaneous administration of immunoglobulins
1106901|NCT00546871|O2|Outcome|SNSC|Dataset of participants naïve to SC administration of immunoglobulins
1106902|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
1106903|NCT00546871|O3|Outcome|SESC|Dataset of participants with prior experience with subcutaneous administration of immunoglobulins
1106904|NCT00546871|O2|Outcome|SNSC|Dataset of participants naïve to SC administration of immunoglobulins
1106905|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
1106906|NCT00546871|O3|Outcome|SESC|Dataset of participants with prior experience with subcutaneous administration of immunoglobulins
1106907|NCT00546871|O2|Outcome|SNSC|Dataset of participants naïve to SC administration of immunoglobulins
1106908|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
1106909|NCT00546871|O3|Outcome|SESC|Dataset of participants with prior experience with subcutaneous administration of immunoglobulins
1106910|NCT00546871|O2|Outcome|SNSC|Dataset of participants naïve to SC administration of immunoglobulins
1106911|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
1106912|NCT00546871|O6|Outcome|Total SC (Parts 2, 3a, 3b, Extension)|
1106913|NCT00546871|O5|Outcome|Study Extension, SC Administration|
1106914|NCT00546871|O4|Outcome|Study Part 3b, SC Administration|
1106915|NCT00546871|O3|Outcome|Study Part 3a, SC Administration|
1106916|NCT00546871|O2|Outcome|Study Part 2, SC Administration|
1106917|NCT00546871|O1|Outcome|Study Part 1, IV Administration|
1106918|NCT00546871|O6|Outcome|Total SC (Parts 2, 3a, 3b, Extension)|
1106919|NCT00546871|O5|Outcome|Study Extension, SC Administration|
1106920|NCT00546871|O4|Outcome|Study Part 3b, SC Administration|
1106921|NCT00546871|O3|Outcome|Study Part 3a, SC Administration|
1106922|NCT00546871|O2|Outcome|Study Part 2, SC Administration|
1106923|NCT00546871|O1|Outcome|Study Part 1, IV Administration|
1106924|NCT00546871|O6|Outcome|Total SC (Parts 2, 3a, 3b, Extension)|
1106946|NCT00546871|O2|Outcome|Study Part 2, SC Administration|
1106947|NCT00546871|O1|Outcome|Study Part 1, IV Administration|
1106948|NCT00546871|O2|Outcome|Infusion Rate Change - For Tolerability/AE|Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs
1106949|NCT00546871|O1|Outcome|Infusion Rate Change - For Any Reason|Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Any Reason
1106950|NCT00546871|O3|Outcome|SESC|Dataset of participants with prior experience with subcutaneous administration of immunoglobulins
1106951|NCT00546871|O2|Outcome|SNSC|Dataset of participants naïve to SC administration of immunoglobulins
1106952|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
1106953|NCT00546871|O3|Outcome|SESC|Dataset of participants with prior experience with subcutaneous administration of immunoglobulins
1106954|NCT00546871|O2|Outcome|SNSC|Dataset of participants naïve to SC administration of immunoglobulins
1106955|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
1106956|NCT00546871|O3|Outcome|SESC|Dataset of participants with prior experience with subcutaneous administration of immunoglobulins
1106957|NCT00546871|O2|Outcome|SNSC|Dataset of participants naïve to SC administration of immunoglobulins
1106958|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
1106959|NCT00546871|O3|Outcome|SESC|Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins
1106960|NCT00546871|O2|Outcome|SNSC|Dataset of subjects naïve to SC administration of immunoglobulins
1106961|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
1106962|NCT00546871|O2|Outcome|All SC Treatment Periods|Study Parts 2, 3a, 3b, extension
1106963|NCT00546871|O1|Outcome|IV Treatment|Study Part 1
1106964|NCT00546871|O2|Outcome|12 Years and Older|
1106965|NCT00546871|O1|Outcome|2 to <12 Years|
1106966|NCT00546871|O1|Outcome|Full Safety Data Set|
1106967|NCT00546871|O1|Outcome|All Participants|
1107336|NCT00546273|P4|Participant Flow|RUTI 200 Micrograms of FCMtb|RUTI dose: 200 micrograms of FCMtb
1106969|NCT00546871|O1|Outcome|Infusion Rate Change - For Any Reason|Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Any Reason
1106970|NCT00546871|O1|Outcome|All Participants|
1106971|NCT00546871|O1|Outcome|All Participants|
1106972|NCT00546871|O1|Outcome|12 Years and Older|
1106973|NCT00546871|O1|Outcome|12 Years and Older|
1106974|NCT00546871|O1|Outcome|12 Years and Older|
1106975|NCT00546871|O1|Outcome|12 Years and Older|
1106976|NCT00546871|O1|Outcome|12 Years and Older|
1106977|NCT00546871|O1|Outcome|12 Years and Older|
1106978|NCT00546871|O1|Outcome|12 Years and Older|
1106979|NCT00546871|O1|Outcome|12 Years and Older|
1106980|NCT00546871|O1|Outcome|12 Years and Older|
1106981|NCT00546871|O1|Outcome|12 Years and Older|
1106982|NCT00546871|O1|Outcome|12 Years and Older|
1106983|NCT00546871|O1|Outcome|12 Years and Older|
1106984|NCT00546871|O1|Outcome|12 Years and Older|
1106985|NCT00546871|O1|Outcome|12 Years and Older|
1106986|NCT00546871|O1|Outcome|Participants Aged 2 to <12 Years|
1106987|NCT00546871|O1|Outcome|Participants ≥12 Years Old With PK Data Part 1 and Part 3b|"IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks).~SC dosing for Study Part 3b was determined by:~From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the Adjusted Dose.~Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an Individually Adapted Dose to ensure sufficient trough levels.~Study Part 3b:~Participants received weekly SC infusions for 12 weeks. Dose administered was either:~The Adjusted Dose~Individually Adapted Dose"
1106988|NCT00546871|E2|Reported Event|SC Treatment Period|Study Parts 2, 3a, 3b, and Extension
1106989|NCT00546871|E1|Reported Event|IV Treatment Period|Study Part 1
1106990|NCT00546819|B3|Baseline|Total|Total of all reporting groups
1106991|NCT00546819|B2|Baseline|Placebo|Participants administered Placebo on Day 1.
1106992|NCT00546819|B1|Baseline|ZOSTAVAX™|Participants administered ZOSTAVAX™ on Day 1.
1106993|NCT00546819|P2|Participant Flow|Placebo|Participants administered Placebo on Day 1.
1106994|NCT00546819|P1|Participant Flow|ZOSTAVAX™|Participants administered ZOSTAVAX™ on Day 1.
1106995|NCT00546819|O2|Outcome|Placebo|Participants administered Placebo on Day 1.
1106996|NCT00546819|O1|Outcome|ZOSTAVAX™|Participants administered ZOSTAVAX™ on Day 1.
1106997|NCT00546819|O2|Outcome|Placebo|Participants administered Placebo on Day 1.
1106998|NCT00546819|O1|Outcome|ZOSTAVAX™|Participants administered ZOSTAVAX™ on Day 1.
1106999|NCT00546819|O2|Outcome|Placebo|Participants administered Placebo on Day 1.
1107000|NCT00546819|O1|Outcome|ZOSTAVAX™|Participants administered ZOSTAVAX™ on Day 1.
1107001|NCT00546819|E2|Reported Event|Placebo|Participants administered Placebo on Day 1.
1107002|NCT00546819|E1|Reported Event|ZOSTAVAX™|Participants administered ZOSTAVAX™ on Day 1.
1107003|NCT00546754|B3|Baseline|Total|Total of all reporting groups
1107004|NCT00546754|B2|Baseline|Valsartan 80 mg/HCTZ 12.5 mg|"Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.~373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (intent-to-treat population [ITT])"
1107005|NCT00546754|B1|Baseline|Losartan 50 mg/HCTZ 12.5 mg|"Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.~416 number of patients that received at least one dose of study medication and had 1 follow-up visit (intent-to-treat population [ITT])"
1107006|NCT00546754|P2|Participant Flow|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
1107227|NCT00546481|B1|Baseline|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
1107007|NCT00546754|P1|Participant Flow|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
1107008|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
1107009|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
1107010|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
1107011|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
1107012|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
1107013|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
1107014|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
1107015|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
1107016|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
1107017|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
1107018|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
1107019|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
1107020|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
1107021|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
1107022|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
1107023|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
1107024|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
1107025|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
1107026|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
1107027|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
1107028|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
1107029|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
1107030|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
1107031|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
1107032|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
1107033|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
1107034|NCT00546754|E2|Reported Event|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
1107035|NCT00546754|E1|Reported Event|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
1107036|NCT00546728|B3|Baseline|Total|Total of all reporting groups
1107037|NCT00546728|B2|Baseline|Metformin|Three months of Metformin therapy. Metformin was initiated at 500 mcg, twice a day for one month and then up titrated to 1000 mcg, twice a day for the remaining two months.
1107038|NCT00546728|B1|Baseline|Exenatide|Three months of Exenatide therapy. Exenatide was initiated at 5 mcg, twice a day for one month and then up titrated to 10 mcg, twice a day for the remaining two months.
1107039|NCT00546728|P2|Participant Flow|Metformin|Three months of Metformin. Metformin was initiated at a dose of 500 mg, twice a day for one month and up titrated to 1000 mg, twice a day for the remaining two months.
1107313|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
1107040|NCT00546728|P1|Participant Flow|Exenatide|Three months of Exenatide. Exenatide was initiated at a dose of 5 mcg, twice a day for one month and up titrated to 10 mcg, twice a day for the remaining two months.
1107041|NCT00546728|O2|Outcome|Metformin|Three months of Metformin therapy. Metformin was initiated at 500 mcg, twice a day for one month and then up titrated to 1000 mcg, twice a day for the remaining two months.
1107042|NCT00546728|O1|Outcome|Exenatide|Three months of Exenatide therapy. Exenatide was initiated at 5 mcg, twice a day for one month and then up titrated to 10 mcg, twice a day for the remaining two months.
1107043|NCT00546728|E2|Reported Event|Metformin|Three months of Metformin therapy. Metformin was initiated at 500 mcg, twice a day for one month and then up titrated to 1000 mcg, twice a day for the remaining two months.
1107044|NCT00546728|E1|Reported Event|Exenatide|Three months of Exenatide therapy. Exenatide was initiated at 5 mcg, twice a day for one month and then up titrated to 10 mcg, twice a day for the remaining two months.
1107045|NCT00546715|B5|Baseline|Total|Total of all reporting groups
1107046|NCT00546715|B4|Baseline|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107047|NCT00546715|B3|Baseline|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107048|NCT00546715|B2|Baseline|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107049|NCT00546715|B1|Baseline|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107050|NCT00546715|P4|Participant Flow|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107051|NCT00546715|P3|Participant Flow|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107052|NCT00546715|P2|Participant Flow|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107053|NCT00546715|P1|Participant Flow|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107054|NCT00546715|O4|Outcome|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107055|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107056|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107057|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107058|NCT00546715|O4|Outcome|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107059|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107060|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107061|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107062|NCT00546715|O4|Outcome|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107063|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107064|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107065|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107066|NCT00546715|O4|Outcome|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107067|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107068|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107069|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107070|NCT00546715|O4|Outcome|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107071|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107072|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107369|NCT00546117|B2|Baseline|Placebo|Placebo SoluTab once daily for 2 months
1107073|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107074|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107075|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107076|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107077|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107078|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107079|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107080|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107081|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107082|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107083|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107084|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107337|NCT00546273|P3|Participant Flow|RUTI 100 Micrograms of FCMtb|RUTI dose: 100 micrograms of FCMtb
1107085|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107086|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107087|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107088|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107089|NCT00546715|O4|Outcome|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107090|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107091|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107092|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107093|NCT00546715|O4|Outcome|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107094|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107095|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107096|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107097|NCT00546715|O4|Outcome|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107098|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107099|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107100|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107101|NCT00546715|E4|Reported Event|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107102|NCT00546715|E3|Reported Event|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107103|NCT00546715|E2|Reported Event|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107314|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
1107104|NCT00546715|E1|Reported Event|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
1107105|NCT00546637|B3|Baseline|Total|Total of all reporting groups
1107106|NCT00546637|B2|Baseline|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107107|NCT00546637|B1|Baseline|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107108|NCT00546637|P2|Participant Flow|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107109|NCT00546637|P1|Participant Flow|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107110|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107191|NCT00546572|O2|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
1107192|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
1107111|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107112|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107113|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107114|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107115|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107116|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107117|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107118|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107258|NCT00546377|O1|Outcome|Pentostatin,Cyclophosphamide,Rituximab & Mitoxantrone|To determine the dose of mitoxantrone that can be safely administered with pentostatin, cyclosphosphamide, and rituximab in previously treated patient with CLL and other low grade B-cell malignancies.
1107490|NCT00545844|O1|Outcome|Treatment Phase (All Patients) Week 0|
1107119|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107120|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107121|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107122|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107123|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107124|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107125|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107126|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107127|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107128|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107129|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107130|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107131|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107132|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107133|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107134|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107135|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107136|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107137|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107138|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107139|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107193|NCT00546572|O2|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
1107194|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
1107195|NCT00546572|O2|Outcome|23vPS / 13vPnC|23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
1107196|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
1107140|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107141|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107142|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107143|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107144|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107145|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107146|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107147|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107148|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107149|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107150|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107151|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107152|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107153|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107197|NCT00546572|O2|Outcome|23vPS / 13vPnC|23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
1107198|NCT00546572|O1|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
1107199|NCT00546572|O2|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
1107154|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107155|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107156|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107157|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107158|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107159|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107160|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107161|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107162|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107163|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107164|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107165|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107166|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107167|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107200|NCT00546572|O1|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
1107201|NCT00546572|O2|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
1107202|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
1107203|NCT00546572|O2|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
1107168|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107169|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107170|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107171|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107172|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107173|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107174|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107175|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107176|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107177|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107178|NCT00546637|E2|Reported Event|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
1107179|NCT00546637|E1|Reported Event|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
1107180|NCT00546572|B3|Baseline|Total|Total of all reporting groups
1107181|NCT00546572|B2|Baseline|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
1107182|NCT00546572|B1|Baseline|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
1107183|NCT00546572|P2|Participant Flow|23vPS / 13vPnC|23-valent pneumococcal polysaccharide conjugate vaccine (23vPS) 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL IM at Year 1 (Vax 2)
1107184|NCT00546572|P1|Participant Flow|13vPnC / 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliters (mL) dose intramuscularly (IM) at Year 0 (vaccination 1 [Vax 1]) and 13vPnC 0.5 mL IM at Year 1 (Vax 2)
1107185|NCT00546572|O2|Outcome|23vPS / 13vPnC|23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
1107186|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
1107187|NCT00546572|O2|Outcome|23vPS / 13vPnC|23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax )
1107188|NCT00546572|O1|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
1107189|NCT00546572|O2|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
1107190|NCT00546572|O1|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
1107206|NCT00546572|O1|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
1107207|NCT00546572|O2|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
1107208|NCT00546572|O1|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
1107209|NCT00546572|O2|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
1107210|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
1107211|NCT00546572|O2|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
1107212|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
1107213|NCT00546572|O2|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
1107214|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
1107215|NCT00546572|O2|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
1107216|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
1107217|NCT00546572|E8|Reported Event|23vPS / 13vPnC 6-M FU (Vax 2 / Year 1)|23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose at Year 1 (Vax 2); events assessed at 6-M FU (Vax 2 / Year 1) telephone visit to report new events.
1107218|NCT00546572|E7|Reported Event|13vPnC / 13vPnC 6-M FU (Vax 2 / Year 1)|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2) ; events assessed at 6-M FU (Vax 2 / Year 1) telephone visit to report new events.
1107219|NCT00546572|E6|Reported Event|23vPS / 13vPnC (Vax 2 / Year 1) 1 Month After Vaccination|"23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)~Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=62; systematic (solicited) Local Reactions N=189; systematic (solicited) Systemic Events N=174."
1107220|NCT00546572|E5|Reported Event|13vPnC / 13vPnC (Vax 2 / Year 1) 1 Month After Vaccination|"13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)~Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=69; systematic (solicited) Local Reactions N=191; systematic (solicited) Systemic Events N=161."
1107221|NCT00546572|E4|Reported Event|23vPS 6-M FU (Vax 1 / Year 0)|23vPS 0.5 mL dose IM at Year 0 (Vax 1); events assessed at 6-M FU (Vax 1 / Year 0) telephone visit to report new events.
1107222|NCT00546572|E3|Reported Event|13vPnC 6-M FU (Vax 1 / Year 0)|13vPnC 0.5 mL dose IM at Year 0 (Vax 1); events assessed at 6-Month Follow-up visit (6-M FU) (Vax 1 / Year 0) telephone visit to report new events.
1107223|NCT00546572|E2|Reported Event|23vPS (Vax 1 / Year 0) 1 Month After Vaccination|"23vPS 0.5 mL dose IM at Year 0 (Vax 1)~Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=83; systematic (solicited) Local Reactions N=248; systematic (solicited) Systemic Events N=275."
1107224|NCT00546572|E1|Reported Event|13vPnC (Vax 1 / Year 0) 1 Month After Vaccination|"13vPnC 0.5 mL dose IM at Year 0 (Vax 1)~Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=66; systematic (solicited) Local Reactions N=209; systematic (solicited) Systemic Events N=234."
1107225|NCT00546481|B3|Baseline|Total|Total of all reporting groups
1107226|NCT00546481|B2|Baseline|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
1107491|NCT00545844|E1|Reported Event|All Patients|
1107228|NCT00546481|P3|Participant Flow|Maintenance Phase: CERA|Eligible participants who achieved a hemoglobin target range of level >=11.0 g/dL at least once during the correction phase (Week 1 to Week 24) without RBC transfusion and completed correction phase treatment, moved to Maintenance phase wherein they were administered CERA (dose adjusted according to the predefined criteria in protocol) IV once every 4 weeks for the subsequent 24 weeks.
1107229|NCT00546481|P2|Participant Flow|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
1107230|NCT00546481|P1|Participant Flow|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
1107231|NCT00546481|O2|Outcome|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
1107232|NCT00546481|O1|Outcome|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
1107233|NCT00546481|O2|Outcome|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
1107234|NCT00546481|O1|Outcome|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
1107235|NCT00546481|O2|Outcome|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
1107236|NCT00546481|O1|Outcome|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
1107237|NCT00546481|O3|Outcome|Maintenance Phase: CERA|Eligible participants who achieved a hemoglobin target range of level >=11.0 g/dL at least once during the correction phase (Week 1 to Week 24) without RBC transfusion and completed correction phase treatment, moved to Maintenance phase wherein they were administered CERA (dose adjusted according to the predefined criteria in protocol) IV once every 4 weeks for the subsequent 24 weeks.
1107238|NCT00546481|O2|Outcome|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
1107239|NCT00546481|O1|Outcome|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
1107240|NCT00546481|O3|Outcome|Maintenance Phase: CERA|Eligible participants who achieved a hemoglobin target range of level >=11.0 g/dL at least once during the correction phase (Week 1 to Week 24) without RBC transfusion and completed correction phase treatment, moved to Maintenance phase wherein they were administered CERA (dose adjusted according to the predefined criteria in protocol) IV once every 4 weeks for the subsequent 24 weeks.
1107241|NCT00546481|O2|Outcome|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
1107242|NCT00546481|O1|Outcome|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
1107243|NCT00546481|O2|Outcome|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
1107244|NCT00546481|O1|Outcome|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
1107245|NCT00546481|O2|Outcome|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
1107246|NCT00546481|O1|Outcome|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
1107247|NCT00546481|O2|Outcome|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
1107248|NCT00546481|O1|Outcome|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
1107249|NCT00546481|E3|Reported Event|Maintenance Phase: CERA|Eligible participants who achieved a hemoglobin target range of level >=11.0 g/dL at least once during the correction phase (Week 1 to Week 24) without RBC transfusion and completed correction phase treatment, moved to Maintenance phase wherein they were administered CERA (dose adjusted according to the predefined protocol) IV once every 4 weeks for the subsequent 24 weeks.
1107250|NCT00546481|E2|Reported Event|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
1107251|NCT00546481|E1|Reported Event|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
1107252|NCT00546429|B1|Baseline|DePuy Orthopaedics ATN Trochanteric Nail System|The participants in this study will undergo treatment of trochanteric fractures using DePuy Orthopaedics ATN Trochanteric Nail System implants and results will be reviewed by clinical and radiographic evaluations.
1107253|NCT00546429|P1|Participant Flow|DePuy Orthopaedics ATN Trochanteric Nail System|The participants in this study will undergo treatment of trochanteric fractures using DePuy Orthopaedics ATN Trochanteric Nail System implants and results will be reviewed by clinical and radiographic evaluations.
1107254|NCT00546429|O1|Outcome|DePuy Orthopaedics ATN Trochanteric Nail System|The participants in this study will undergo treatment of trochanteric fractures using DePuy Orthopaedics ATN Trochanteric Nail System implants and results will be reviewed by clinical and radiographic evaluations.
1107255|NCT00546429|E1|Reported Event|DePuy Orthopaedics ATN Trochanteric Nail System|The participants in this study will undergo treatment of trochanteric fractures using DePuy Orthopaedics ATN Trochanteric Nail System implants and results will be reviewed by clinical and radiographic evaluations.
1107256|NCT00546377|B1|Baseline|Pentostatin,Cyclophosphamide,Rituximab & Mitoxantrone|To determine the dose of mitoxantrone that can be safely administered with pentostatin, cyclosphosphamide, and rituximab in previously treated patient with CLL and other low grade B-cell malignancies.
1107257|NCT00546377|P1|Participant Flow|Pentostatin,Cyclophosphamide,Rituximab & Mitoxantrone|To determine the dose of mitoxantrone that can be safely administered with pentostatin, cyclosphosphamide, and rituximab in previously treated patient with CLL and other low grade B-cell malignancies.
1107311|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
1107259|NCT00546377|O1|Outcome|Pentostatin,Cyclophosphamide,Rituximab & Mitoxantrone|To determine the dose of mitoxantrone that can be safely administered with pentostatin, cyclosphosphamide, and rituximab in previously treated patient with CLL and other low grade B-cell malignancies.
1107260|NCT00546377|E1|Reported Event|Pentostatin,Cyclophosphamide,Rituximab & Mitoxantrone|To determine the dose of mitoxantrone that can be safely administered with pentostatin, cyclosphosphamide, and rituximab in previously treated patient with CLL and other low grade B-cell malignancies.
1107261|NCT00546364|B4|Baseline|Total|Total of all reporting groups
1107262|NCT00546364|B3|Baseline|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107263|NCT00546364|B2|Baseline|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107264|NCT00546364|B1|Baseline|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107265|NCT00546364|P3|Participant Flow|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107266|NCT00546364|P2|Participant Flow|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107267|NCT00546364|P1|Participant Flow|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107268|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107335|NCT00546273|P5|Participant Flow|Placebo|placebo of the vaccine RUTI, given subcutaneously twice, on days 0 and 28
1109752|NCT00540124|O1|Outcome|Placebo|by mouth once a day
1107269|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107270|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107271|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107272|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107273|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107274|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107275|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107276|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107277|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107278|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107279|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107280|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107312|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
1107281|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107282|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107283|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107284|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107285|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107286|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107287|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107288|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107289|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107290|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107291|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107292|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107293|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107294|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107295|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107296|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107297|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
1107298|NCT00546364|E3|Reported Event|Ixabepilone 40|
1107299|NCT00546364|E2|Reported Event|Ixabepilone 32|
1107300|NCT00546364|E1|Reported Event|Docetaxel|
1107301|NCT00546351|B1|Baseline|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
1107302|NCT00546351|P1|Participant Flow|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
1107303|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
1107304|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
1107305|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
1107306|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
1107307|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
1107308|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
1107309|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
1107310|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
1107315|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
1107316|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
1107317|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
1107318|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
1107319|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
1107320|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
1107321|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
1107322|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
1107323|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
1107324|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
1107325|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
1107326|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
1107327|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
1107328|NCT00546351|E1|Reported Event|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
1107329|NCT00546273|B6|Baseline|Total|Total of all reporting groups
1107330|NCT00546273|B5|Baseline|Placebo|placebo of the vaccine RUTI, given subcutaneously twice, on days 0 and 28
1107331|NCT00546273|B4|Baseline|RUTI 200 Micrograms of FCMtb|RUTI dose: 200 micrograms of FCMtb
1107332|NCT00546273|B3|Baseline|RUTI 100 Micrograms of FCMtb|RUTI dose: 100 micrograms of FCMtb
1107333|NCT00546273|B2|Baseline|RUTI 25 Micrograms of FCMtb|RUTI dose: 25 micrograms of FCMtb
1107334|NCT00546273|B1|Baseline|RUTI 5 Micrograms of FCMtb|RUTI dose: 5 micrograms of FCMtb
1107338|NCT00546273|P2|Participant Flow|RUTI 25 Micrograms of FCMtb|RUTI dose: 25 micrograms of FCMtb
1107339|NCT00546273|P1|Participant Flow|RUTI 5 Micrograms of FCMtb|RUTI dose: 5 micrograms of FCMtb
1107340|NCT00546273|O5|Outcome|Placebo|placebo of the vaccine RUTI, given subcutaneously twice, on days 0 and 28
1107341|NCT00546273|O4|Outcome|RUTI 200 Micrograms of FCMtb|RUTI dose: 200 micrograms of FCMtb
1107342|NCT00546273|O3|Outcome|RUTI 100 Micrograms of FCMtb|RUTI dose: 100 micrograms of FCMtb
1107343|NCT00546273|O2|Outcome|RUTI 25 Micrograms of FCMtb|RUTI dose: 25 micrograms of FCMtb
1107344|NCT00546273|O1|Outcome|RUTI 5 Micrograms of FCMtb|RUTI dose: 5 micrograms of FCMtb
1107345|NCT00546260|B3|Baseline|Total|Total of all reporting groups
1107346|NCT00546260|B2|Baseline|Experimental|Experimental Cohorts (10, 20, 40, 60 mg)
1107347|NCT00546260|B1|Baseline|Placebo|Placebo Comparator
1107348|NCT00546260|P2|Participant Flow|Experimental|Experimental Cohorts (10, 20, 40, 60 mg)
1107349|NCT00546260|P1|Participant Flow|Placebo|Placebo Comparator
1107350|NCT00546260|O2|Outcome|Experimental|Experimental Cohorts (10, 20, 40, 60 mg)
1107351|NCT00546260|O1|Outcome|Placebo|Placebo Comparator
1107352|NCT00546260|O2|Outcome|Experimental|Experimental Cohorts (10, 20, 40, 60 mg)
1107353|NCT00546260|O1|Outcome|Placebo|Placebo Comparator
1107354|NCT00546260|O2|Outcome|Experimental|Experimental Cohorts (10, 20, 40, 60 mg)
1107355|NCT00546260|O1|Outcome|Placebo|Placebo Comparator
1107356|NCT00546260|E2|Reported Event|Experimental|Experimental Cohorts (10, 20, 40, 60 mg)
1107357|NCT00546260|E1|Reported Event|Placebo|Placebo Comparator
1107358|NCT00546156|B3|Baseline|Total|Total of all reporting groups
1107359|NCT00546156|B2|Baseline|Triple Negative Breast Cancer Cohort|Hormone receptor negative, HER2 negative Cohort. Receive same drug protocol as Arm A.
1107360|NCT00546156|B1|Baseline|HR+, HER2-|Patients with Hormone Receptor Positive, HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.
1107361|NCT00546156|P2|Participant Flow|Triple Negative Breast Cancer Cohort|Hormone receptor negative, HER2 negative Cohort. Receive same drug protocol as Arm A.
1107362|NCT00546156|P1|Participant Flow|HR+, HER2-|Patients with Hormone Receptor Positive, HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.
1107363|NCT00546156|O2|Outcome|Triple Negative Breast Cancer Cohort|Hormone receptor negative, HER2 negative Cohort. Receive same drug protocol as Arm A.
1107364|NCT00546156|O1|Outcome|HR+, HER2-|Patients with Hormone Receptor Positive, HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.
1107365|NCT00546156|O2|Outcome|Triple Negative Breast Cancer Cohort|Hormone receptor negative, HER2 negative Cohort. Receive same drug protocol as Arm A.
1107366|NCT00546156|O1|Outcome|HR+, HER2-|Patients with Hormone Receptor Positive, HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.
1107367|NCT00546156|E1|Reported Event|All Study Participants|Patients with HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.
1107368|NCT00546117|B3|Baseline|Total|Total of all reporting groups
1107370|NCT00546117|B1|Baseline|Prevacid|Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months
1107371|NCT00546117|P2|Participant Flow|Placebo|Placebo SoluTab once daily for 2 months
1107372|NCT00546117|P1|Participant Flow|Prevacid|Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months
1107373|NCT00546117|O2|Outcome|Placebo|Placebo SoluTab once daily for 2 months
1107374|NCT00546117|O1|Outcome|Prevacid|Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months
1107375|NCT00546117|O2|Outcome|Placebo|Placebo SoluTab once daily for 2 months
1107376|NCT00546117|O1|Outcome|Prevacid|Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months
1107377|NCT00546117|E2|Reported Event|Placebo|Placebo SoluTab once daily for 2 months
1107378|NCT00546117|E1|Reported Event|Prevacid|Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months
1107379|NCT00546104|B1|Baseline|Dasatinib|50-100mg by mouth twice a day
1107380|NCT00546104|P1|Participant Flow|Dasatinib|50-100 mg PO BID
1107381|NCT00546104|O1|Outcome|Dasatinib|50mg-100mg po BID
1107382|NCT00546104|O1|Outcome|Dasatinib|50mg-100mg po BID
1107383|NCT00546104|O1|Outcome|Dasatinib|50mg-100mg po BID
1107384|NCT00546104|O1|Outcome|Dasatinib|50mg-100mg po BID
1107385|NCT00546104|O1|Outcome|Dasatinib|50mg-100mg po BID
1107386|NCT00546104|O1|Outcome|Dasatinib|50mg-100mg po BID
1107387|NCT00546104|E1|Reported Event|Dasatinib|50-100mg po bid
1107388|NCT00546078|B3|Baseline|Total|Total of all reporting groups
1107389|NCT00546078|B2|Baseline|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
1107390|NCT00546078|B1|Baseline|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
1107391|NCT00546078|P2|Participant Flow|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
1107550|NCT00545740|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
1107392|NCT00546078|P1|Participant Flow|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
1107393|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
1107394|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
1107395|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
1107396|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
1107397|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
1107398|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
1107399|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
1107400|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
1107401|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
1107402|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
1107403|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
1107404|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
1107405|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
1107406|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
1107407|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
1107408|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
1107409|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
1107410|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
1107411|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
1107412|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
1107450|NCT00546000|O1|Outcome|Experimental|"Receive between 22 and 29 days of Cutivate lotion treatment~Fluticasone propionate 0.05% lotion: Daily applications"
1107413|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
1107414|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
1107415|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
1107416|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
1107417|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
1107418|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
1107419|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
1107420|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
1107421|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
1107422|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
1107423|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
1107424|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
1109753|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
1107425|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
1107426|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
1107427|NCT00546078|E2|Reported Event|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
1107428|NCT00546078|E1|Reported Event|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
1107429|NCT00546052|B1|Baseline|Losartan +/- Hydrochlorothiazide|Patients could be titrated up from Cozaar 50 mg to Cozaar 100mg to losartan 100 mg + Hydrochlorothiazide 12.5 mg and losartan 100mg/ Hydrochlorothiazide 25 mg, in sequence at any subsequent visits only if needed to obtain Blood Pressure under 140/90 mm Hg.
1107430|NCT00546052|P1|Participant Flow|Losartan +/- Hydrochlorothiazide|Patients could be titrated up from Cozaar 50 mg to Cozaar 100mg to losartan 100 mg + Hydrochlorothiazide 12.5 mg and losartan 100mg/ Hydrochlorothiazide 25 mg, in sequence at any subsequent visits only if needed to obtain Blood Pressure under 140/90 mm Hg.
1107431|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
1107432|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
1107433|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
1107434|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
1107435|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
1107436|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
1107437|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
1107438|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
1107439|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
1107440|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
1107441|NCT00546052|O3|Outcome|Overall Per Protocol|All patients completing the 52 week study follow up.
1107442|NCT00546052|O2|Outcome|Overall Intend to Treat|All patients enrolled and receiving at least one dose of study drug and having at least one follow up visit.
1107443|NCT00546052|O1|Outcome|Overall Total|All patients enrolled (signed the informed consent).
1107444|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
1107445|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
1107446|NCT00546052|E1|Reported Event|Overall ITT|
1107447|NCT00546000|B1|Baseline|Experimental|"Receive between 22 and 29 days of Cutivate lotion treatment~Fluticasone propionate 0.05% lotion: Daily applications"
1107448|NCT00546000|P1|Participant Flow|Experimental|"Receive between 22 and 29 days of Cutivate lotion treatment~Fluticasone propionate 0.05% lotion: Daily applications"
1107449|NCT00546000|O1|Outcome|Experimental|"Receive between 22 and 29 days of Cutivate lotion treatment~Fluticasone propionate 0.05% lotion: Daily applications"
1107451|NCT00546000|E1|Reported Event|Experimental|"Receive between 22 and 29 days of Cutivate lotion treatment~Fluticasone propionate 0.05% lotion: Daily applications"
1107452|NCT00545974|B3|Baseline|Total|Total of all reporting groups
1107453|NCT00545974|B2|Baseline|Placebo|Placebo (inactive tablets identical to memantine 10mg tablets)
1107454|NCT00545974|B1|Baseline|Memantine|Memantine 10mg administered orally twice daily
1107455|NCT00545974|P2|Participant Flow|Placebo|Placebo (inactive tablets identical to memantine 10mg tablets)
1107456|NCT00545974|P1|Participant Flow|Memantine|Memantine 10mg administered orally twice daily
1107457|NCT00545974|O2|Outcome|Placebo|Placebo (inactive tablets identical to memantine 10mg tablets)
1107458|NCT00545974|O1|Outcome|Memantine|Memantine 10mg administered orally twice daily
1107459|NCT00545974|O2|Outcome|Placebo|Placebo (inactive tablets identical to memantine 10mg tablets)
1107460|NCT00545974|O1|Outcome|Memantine|Memantine 10mg administered orally twice daily
1107461|NCT00545974|E2|Reported Event|Placebo|Placebo (inactive tablets identical to memantine 10mg tablets)
1107462|NCT00545974|E1|Reported Event|Memantine|Memantine 10mg administered orally twice daily
1107463|NCT00545948|B4|Baseline|Total|Total of all reporting groups
1107464|NCT00545948|B3|Baseline|Screen Failures|"Patients who were registered and underwent protocol-based procedure (e.g. biopsy, genomic screening), but were not assigned to or administered genomics-directed, protocol-based therapy.~Note that two patients who were assigned protocol-based treatment (1 in each arm) did not receive the treatment and were added to the 7 initially identified as screen failures within the summary of baseline characteristics and outcome measures."
1107465|NCT00545948|B2|Baseline|Arm B-Pemetrexed|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of pemetrexed sensitivity were given cisplatin + pemetrexed.
1107466|NCT00545948|B1|Baseline|Arm A-Vinorelbine|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of vinorelbine sensitivity were given cisplatin + vinorelbine.
1107551|NCT00545740|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
1107552|NCT00545740|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
1107467|NCT00545948|P3|Participant Flow|Screen Failures|"Patients who were registered and underwent protocol-based procedure (e.g. biopsy, genomic screening), but were not assigned to or administered genomics-directed, protocol-based therapy.~Note that two patients who were assigned protocol-based treatment (1 in each arm) did not receive the treatment and were added to the 7 initially identified as screen failures within the summary of baseline characteristics and outcome measures."
1107468|NCT00545948|P2|Participant Flow|Arm B-Pemetrexed|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of pemetrexed sensitivity were given cisplatin + pemetrexed.
1107469|NCT00545948|P1|Participant Flow|Arm A-Vinorelbine|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of vinorelbine sensitivity were given cisplatin + vinorelbine.
1107470|NCT00545948|O2|Outcome|Arm B-Pemetrexed|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of pemetrexed sensitivity were given cisplatin + pemetrexed.
1107471|NCT00545948|O1|Outcome|Arm A-Vinorelbine|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of vinorelbine sensitivity were given cisplatin + vinorelbine.
1107472|NCT00545948|O1|Outcome|All Registered Patients|All registered/enrolled patients are included in this outcome, which was measured at the time of consent.
1107473|NCT00545948|O1|Outcome|Treatment|Treatment refers to patients treated in the combined vinorelbine and pemetrexed arms of the study.
1107474|NCT00545948|O1|Outcome|All Registered Patients|All registered/enrolled patients are included in this outcome, which was measured at the time of consent.
1107475|NCT00545948|O1|Outcome|Treatment|Treatment refers to patients treated in the combined vinorelbine and pemetrexed arms of the study. Due to the irreproducibility of the genomics-based prediction model for assigning patients into the original cisplatin treatment arms, patients from both arms were combined for primary outcome analysis.
1107476|NCT00545948|E2|Reported Event|Arm B-Pemetrexed|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of pemetrexed sensitivity were given cisplatin + pemetrexed.
1107477|NCT00545948|E1|Reported Event|Arm A-Vinorelbine|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of vinorelbine sensitivity were given cisplatin + vinorelbine.
1107478|NCT00545844|B1|Baseline|All Patients|"montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment~Patients with comorbid allergic rhinitis and uncontrolled asthma were invited to participate in the treatment phase of the study. Of the 1004 patients who completed the survey phase, there were 319 eligible patients who advanced and participated in the treatment phase. Of the 319 eligible patients who advanced to the treatment phase 6 did not meet inclusion criteria leaving 313 patients."
1107479|NCT00545844|P1|Participant Flow|All Patients|"montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment~Patients with comorbid allergic rhinitis and uncontrolled asthma were invited to participate in the treatment phase of the study. Of the 1004 patients who completed the survey phase, there were 319 eligible patients who advanced and participated in the treatment phase. Of the 319 eligible patients who advanced to the treatment phase 6 did not meet inclusion criteria leaving 313 patients."
1107480|NCT00545844|O2|Outcome|Treatment Phase (All Patients) Week 8|
1107481|NCT00545844|O1|Outcome|Treatment Phase (All Patients) Week 0|
1107482|NCT00545844|O2|Outcome|Treatment Phase (All Patients) Week 8|
1107483|NCT00545844|O1|Outcome|Treatment Phase (All Patients) Week 0|
1107484|NCT00545844|O2|Outcome|Treatment Phase (All Patients) Week 8|
1107485|NCT00545844|O1|Outcome|Treatment Phase (All Patients) Week 0|
1107486|NCT00545844|O2|Outcome|Treatment Phase (All Patients) Week 8|
1107487|NCT00545844|O1|Outcome|Treatment Phase (All Patients) Week 0|
1107488|NCT00545844|O1|Outcome|Treatment Phase (All Patients) Week 8|
1107489|NCT00545844|O2|Outcome|Treatment Phase (All Patients) Week 8|
1107492|NCT00545792|B1|Baseline|Avastin|"Avastin and daily radiation~Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses."
1107493|NCT00545792|P1|Participant Flow|Avastin|"Avastin and daily radiation~Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses."
1107494|NCT00545792|O1|Outcome|Avastin|"Avastin and daily radiation~Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses."
1107495|NCT00545792|O1|Outcome|Avastin|"Avastin and daily radiation~Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses."
1107496|NCT00545792|E1|Reported Event|Avastin|"Avastin and daily radiation~Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses."
1107497|NCT00545779|B1|Baseline|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
1107498|NCT00545779|P1|Participant Flow|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
1107499|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
1107500|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
1107501|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
1107502|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
1107503|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
1107504|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
1107505|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
1107506|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
1107507|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
1107508|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
1107509|NCT00545779|E1|Reported Event|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
1107510|NCT00545766|B1|Baseline|Vinflunine|Vinflunine : Vinflunine 320 mg/m2 will be administered as a 20 minute IV infusion q3w. Patients will be evaluated for toxicity after each cycle of therapy. Response to vinflunine will be assessed every 6 weeks (every 2 cycles) of treatment. A maximum of 6 cycles of therapy are planned.
1107511|NCT00545766|P1|Participant Flow|Vinflunine|Vinflunine : Vinflunine 320 mg/m2 will be administered as a 20 minute IV infusion q3w. Patients will be evaluated for toxicity after each cycle of therapy. Response to vinflunine will be assessed every 6 weeks (every 2 cycles) of treatment. A maximum of 6 cycles of therapy are planned.
1107512|NCT00545766|O1|Outcome|Vinflunine|Vinflunine : Vinflunine 320 mg/m2 will be administered as a 20 minute IV infusion q3w. Patients will be evaluated for toxicity after each cycle of therapy. Response to vinflunine will be assessed every 6 weeks (every 2 cycles) of treatment. A maximum of 6 cycles of therapy are planned.
1107513|NCT00545766|E1|Reported Event|Vinflunine|Vinflunine : Vinflunine 320 mg/m2 will be administered as a 20 minute IV infusion q3w. Patients will be evaluated for toxicity after each cycle of therapy. Response to vinflunine will be assessed every 6 weeks (every 2 cycles) of treatment. A maximum of 6 cycles of therapy are planned.
1107514|NCT00545753|B4|Baseline|Total|Total of all reporting groups
1107515|NCT00545753|B3|Baseline|C - NIX Applied Per Over the Counter (OTC) Instructions|NIX Creme Rinse applied to Over the Counter (OTC) Instructions for Use
1107516|NCT00545753|B2|Baseline|B - NatrOVA 1% - Nit Combing Required|NatrOVA Creme Rinse - 1% - nit comb regimen required
1107517|NCT00545753|B1|Baseline|A - NatrOVA 1% - No Nit Combing Required|NatrOVA Creme Rinse - 1% - no nit combing required
1107518|NCT00545753|P3|Participant Flow|C - NIX Applied Per Over the Counter (OTC) Instructions|NIX Creme Rinse (permethrin 1%) applied to Over the Counter (OTC) Instructions for Use
1107519|NCT00545753|P2|Participant Flow|B - NatrOVA 1% - Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - nit comb regimen required
1107520|NCT00545753|P1|Participant Flow|A - NatrOVA 1% - No Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - no nit combing required
1107521|NCT00545753|O2|Outcome|C - NIX Applied Per Over the Counter (OTC) Instructions|NIX Creme Rinse (permethrin 1%) applied to Over the Counter (OTC) Instructions for Use
1107522|NCT00545753|O1|Outcome|A/B - NatrOVA 1% - With/Without Nit Combing|NatrOVA Creme Rinse (spinosad) 1% - With or without nit combing required
1107523|NCT00545753|O3|Outcome|C - NIX Applied Per Over the Counter (OTC) Instructions|NIX Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC)Instructions for Use
1107524|NCT00545753|O2|Outcome|B - NatrOVA 1% - Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - nit comb regimen required
1107525|NCT00545753|O1|Outcome|A - NatrOVA 1% - No Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - no nit combing required
1114306|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
1107526|NCT00545753|E2|Reported Event|C - NIX Applied Per Over the Counter (OTC) Instructions|NIX Creme Rinse applied to Over the Counter (OTC) Instructions for Use
1107527|NCT00545753|E1|Reported Event|A/B - NatrOVA 1% - With/Without Nit Combing|NatrOVA Creme Rinse - 1% - With or without nit combing
1107528|NCT00545740|B5|Baseline|Total|Total of all reporting groups
1107529|NCT00545740|B4|Baseline|Placebo|Placebo administered orally once daily
1107530|NCT00545740|B3|Baseline|SPD476 (4.8 g)|4.8 g administered orally once daily
1107531|NCT00545740|B2|Baseline|SPD476 (2.4 g)|2.4 g administered orally once daily
1107532|NCT00545740|B1|Baseline|SPD476 (1.2 g)|1.2 g administered orally once daily
1107533|NCT00545740|P4|Participant Flow|Placebo|Placebo administered orally once daily
1107534|NCT00545740|P3|Participant Flow|SPD476 (4.8 g)|4.8 g administered orally once daily
1107535|NCT00545740|P2|Participant Flow|SPD476 (2.4 g)|2.4 g administered orally once daily
1107536|NCT00545740|P1|Participant Flow|SPD476 (1.2 g)|1.2 g administered orally once daily
1107537|NCT00545740|O4|Outcome|Placebo|Placebo administered orally once daily
1107538|NCT00545740|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
1107539|NCT00545740|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
1107540|NCT00545740|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
1107541|NCT00545740|O4|Outcome|Placebo|Placebo administered orally once daily
1107542|NCT00545740|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
1107543|NCT00545740|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
1107544|NCT00545740|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
1107545|NCT00545740|O4|Outcome|Placebo|Placebo administered orally once daily
1107546|NCT00545740|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
1107547|NCT00545740|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
1107548|NCT00545740|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
1107549|NCT00545740|O4|Outcome|Placebo|Placebo administered orally once daily
1107553|NCT00545740|O4|Outcome|Placebo|Placebo administered orally once daily
1107554|NCT00545740|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
1107555|NCT00545740|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
1107556|NCT00545740|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
1107557|NCT00545740|O4|Outcome|Placebo|Placebo administered orally once daily
1107558|NCT00545740|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
1107559|NCT00545740|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
1107560|NCT00545740|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
1107561|NCT00545740|O4|Outcome|Placebo|Placebo administered orally once daily
1107562|NCT00545740|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
1107563|NCT00545740|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
1107564|NCT00545740|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
1107565|NCT00545740|E4|Reported Event|Placebo|Placebo administered orally once daily
1107566|NCT00545740|E3|Reported Event|SPD476 (4.8 g)|4.8 g administered orally once daily
1107567|NCT00545740|E2|Reported Event|SPD476 (2.4 g)|2.4 g administered orally once daily
1107568|NCT00545740|E1|Reported Event|SPD476 (1.2 g)|1.2 g administered orally once daily
1107569|NCT00545688|B5|Baseline|Total|Total of all reporting groups
1107570|NCT00545688|B4|Baseline|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
1107571|NCT00545688|B3|Baseline|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
1107572|NCT00545688|B2|Baseline|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107573|NCT00545688|B1|Baseline|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107714|NCT00545441|P1|Participant Flow|Surgisis® AFP|Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP): Surgical placement of the Surgisis AFP is performed under general anesthesia.
1107715|NCT00545441|O2|Outcome|Flap|Flap: Advancement flap surgery is performed; no anal fistula plug is placed
1107574|NCT00545688|P4|Participant Flow|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
1107575|NCT00545688|P3|Participant Flow|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
1107576|NCT00545688|P2|Participant Flow|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107597|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107577|NCT00545688|P1|Participant Flow|Trastuzumab + Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab intravenous (IV) infusion at a loading dose of 8 milligrams per kilogram (mg/kg) on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 milligrams per square meter (mg/m^2) on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by 5-fluorouracil 600 mg/m^2 IV, epirubicin 90 mg/m^2 IV, and cyclophosphamide 600 mg/m^2 IV (FEC) on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107578|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
1107579|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
1107580|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107581|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107582|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
1107716|NCT00545441|O1|Outcome|Surgisis® AFP|Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP): Surgical placement of the Surgisis AFP is performed under general anesthesia.
1107583|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
1107584|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107585|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107586|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
1107785|NCT00545272|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1109754|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
1107587|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
1107588|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107589|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107590|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a loading dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
1107591|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
1107622|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
1107592|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a loading dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107593|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a loading dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107594|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
1107595|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
1107596|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107786|NCT00545272|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107598|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
1107599|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
1107600|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107601|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107602|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
1107942|NCT00545103|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
1107603|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
1107604|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107605|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107606|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
1107607|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
1107787|NCT00545272|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1109755|NCT00540124|O1|Outcome|Placebo|by mouth once a day
1107608|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107609|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107610|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
1107611|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
1107642|NCT00545688|E4|Reported Event|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
1107612|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107613|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107614|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
1107615|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
1107616|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107617|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107652|NCT00545662|O1|Outcome|Control|The first dose of placebo was administered within 24 hours of traumatic brain injury. Placebo was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
1107618|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
1107619|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
1107620|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107621|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107623|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
1107624|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107625|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107626|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
1107627|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
1107788|NCT00545272|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1108463|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
1107628|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107629|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107630|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
1107631|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
1107671|NCT00545623|E1|Reported Event|ACUP+RR|"acupuncture + relaxation response CD~Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks~Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
1107672|NCT00545584|B4|Baseline|Total|Total of all reporting groups
1107717|NCT00545441|E2|Reported Event|Flap|Flap: Advancement flap surgery is performed; no anal fistula plug is placed
1107943|NCT00545103|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
1107632|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107633|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107634|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
1107635|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
1107636|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107637|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107653|NCT00545662|E2|Reported Event|Treatment|Treatment with citicoline begun within 24 hours of traumatic brain injury. Treatment was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
1107638|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
1107639|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
1107640|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107641|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107643|NCT00545688|E3|Reported Event|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
1107644|NCT00545688|E2|Reported Event|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107645|NCT00545688|E1|Reported Event|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
1107646|NCT00545662|B3|Baseline|Total|Total of all reporting groups
1107647|NCT00545662|B2|Baseline|Treatment|Treatment with citicoline begun within 24 hours of traumatic brain injury. Treatment was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
1107648|NCT00545662|B1|Baseline|Control|The first dose of placebo was administered within 24 hours of traumatic brain injury. Placebo was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
1107649|NCT00545662|P2|Participant Flow|Treatment|Treatment with citicoline begun within 24 hours of traumatic brain injury. Treatment was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
1107650|NCT00545662|P1|Participant Flow|Control|The first dose of placebo was administered within 24 hours of traumatic brain injury. Placebo was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
1107651|NCT00545662|O2|Outcome|Treatment|Treatment with citicoline begun within 24 hours of traumatic brain injury. Treatment was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
1108464|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
1107654|NCT00545662|E1|Reported Event|Control|The first dose of placebo was administered within 24 hours of traumatic brain injury. Placebo was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
1107655|NCT00545623|B5|Baseline|Total|Total of all reporting groups
1107656|NCT00545623|B4|Baseline|SHAM+EDU|"sham acupuncture+education CD~sham acupuncture: sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
1107657|NCT00545623|B3|Baseline|ACUP+EDU|"acupuncture+education CD~Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
1107658|NCT00545623|B2|Baseline|SHAM+RR|"sham acupuncture + relaxation response CD~Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
1107659|NCT00545623|B1|Baseline|ACUP+RR|"acupuncture + relaxation response CD~Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks~Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
1107660|NCT00545623|P4|Participant Flow|SHAM+EDU|"sham acupuncture+education CD~sham acupuncture: sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
1107661|NCT00545623|P3|Participant Flow|ACUP+EDU|"acupuncture+education CD~Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
1107662|NCT00545623|P2|Participant Flow|SHAM+RR|"sham acupuncture + relaxation response CD~Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
1107663|NCT00545623|P1|Participant Flow|ACUP+RR|"acupuncture + relaxation response CD~Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks~Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
1107664|NCT00545623|O4|Outcome|SHAM+EDU|"sham acupuncture+education CD~sham acupuncture: sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
1107665|NCT00545623|O3|Outcome|ACUP+EDU|"acupuncture+education CD~Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
1107666|NCT00545623|O2|Outcome|SHAM+RR|"sham acupuncture + relaxation response CD~Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
1107667|NCT00545623|O1|Outcome|ACUP+RR|"acupuncture + relaxation response CD~Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks~Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
1107668|NCT00545623|E4|Reported Event|SHAM+EDU|"sham acupuncture+education CD~sham acupuncture: sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
1107669|NCT00545623|E3|Reported Event|ACUP+EDU|"acupuncture+education CD~Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
1107670|NCT00545623|E2|Reported Event|SHAM+RR|"sham acupuncture + relaxation response CD~Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
1107673|NCT00545584|B3|Baseline|Sitagliptin With Diet and Physical Activity Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week."
1107674|NCT00545584|B2|Baseline|Sitagliptin With Diet Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet which includes advice on diet with a leaflet and a diary"
1107675|NCT00545584|B1|Baseline|Sitagliptin With Standard of Care|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~No specific intervention (standard recommendation) on physical exercise and diet."
1107676|NCT00545584|P3|Participant Flow|Sitagliptin With Diet and Physical Activity Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week."
1107677|NCT00545584|P2|Participant Flow|Sitagliptin With Diet Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet which includes advice on diet with a leaflet and a diary"
1107678|NCT00545584|P1|Participant Flow|Sitagliptin With Standard of Care|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~No specific intervention (standard recommendation) on physical exercise and diet."
1107679|NCT00545584|O3|Outcome|Sitagliptin With Diet and Physical Activity Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week."
1107680|NCT00545584|O2|Outcome|Sitagliptin With Diet Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet which includes advice on diet with a leaflet and a diary"
1107681|NCT00545584|O1|Outcome|Sitagliptin With Standard of Care|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~No specific intervention (standard recommendation) on physical exercise and diet."
1107682|NCT00545584|O3|Outcome|Sitagliptin With Diet and Physical Activity Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week."
1107683|NCT00545584|O2|Outcome|Sitagliptin With Diet Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet which includes advice on diet with a leaflet and a diary"
1107684|NCT00545584|O1|Outcome|Sitagliptin With Standard of Care|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~No specific intervention (standard recommendation) on physical exercise and diet."
1108077|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
1107685|NCT00545584|E3|Reported Event|Sitagliptin With Diet and Physical Activity Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week."
1107686|NCT00545584|E2|Reported Event|Sitagliptin With Diet Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet which includes advice on diet with a leaflet and a diary"
1107687|NCT00545584|E1|Reported Event|Sitagliptin With Standard of Care|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~No specific intervention (standard recommendation) on physical exercise and diet."
1107688|NCT00545571|B1|Baseline|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
1107689|NCT00545571|P1|Participant Flow|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with erythropoiesis-stimulating agent (ESA) therapy received intravenous methoxy polyethylene glycol-epoetin beta (Mircera), also known as continuous erythropoietin receptor activator (CERA), every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 micrograms (mcg) was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week dose titration period (DTP) to maintain hemoglobin (Hb) concentrations within a country-specific target: 11.0 to 13.0 grams per deciliter (g/dL) in Switzerland and 10.0 to 12.0 g/dL in Austria.
1107690|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
1107691|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
1107692|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
1107712|NCT00545441|B1|Baseline|Surgisis® AFP|Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP): Surgical placement of the Surgisis AFP is performed under general anesthesia.
1107693|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
1107694|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
1107695|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
1107696|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
1107697|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
1107698|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
1107699|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
1107700|NCT00545571|E1|Reported Event|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
1107701|NCT00545506|B3|Baseline|Total|Total of all reporting groups
1107702|NCT00545506|B2|Baseline|Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen|warming bandage on sternal wound The Warm-Up bandage consists of an adhesive shell and a foam frame that supports a clear window about one cm above the surface of the wound. A battery-powered heating card can then be inserted into the window to provide gentle warming of the wound. The experimental bandage will be continuously applied to the wound and heated to 38°C using a two-hour on/off cycle
1107703|NCT00545506|B1|Baseline|Heart Surgery, Wound Infection, Conventional Bandage|konventional bandage (conventional gauze covered with elastic adhesive (Medipore™ Dress-it)) on sternal wound
1107704|NCT00545506|P2|Participant Flow|Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen|warming bandage on sternal wound The Warm-Up bandage consists of an adhesive shell and a foam frame that supports a clear window about one cm above the surface of the wound. A battery-powered heating card can then be inserted into the window to provide gentle warming of the wound. The experimental bandage will be continuously applied to the wound and heated to 38°C using a two-hour on/off cycle
1107705|NCT00545506|P1|Participant Flow|Heart Surgery, Wound Infection, Conventional Bandage|konventional bandage (conventional gauze covered with elastic adhesive (Medipore™ Dress-it)) on sternal wound
1107706|NCT00545506|O2|Outcome|Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen|warming bandage on sternal wound The Warm-Up bandage consists of an adhesive shell and a foam frame that supports a clear window about one cm above the surface of the wound. A battery-powered heating card can then be inserted into the window to provide gentle warming of the wound. The experimental bandage will be continuously applied to the wound and heated to 38°C using a two-hour on/off cycle
1107707|NCT00545506|O1|Outcome|Heart Surgery, Wound Infection, Conventional Bandage|konventional bandage (conventional gauze covered with elastic adhesive (Medipore™ Dress-it)) on sternal wound
1107708|NCT00545506|E2|Reported Event|Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen|warming bandage on sternal wound The Warm-Up bandage consists of an adhesive shell and a foam frame that supports a clear window about one cm above the surface of the wound. A battery-powered heating card can then be inserted into the window to provide gentle warming of the wound. The experimental bandage will be continuously applied to the wound and heated to 38°C using a two-hour on/off cycle
1107709|NCT00545506|E1|Reported Event|Heart Surgery, Wound Infection, Conventional Bandage|konventional bandage (conventional gauze covered with elastic adhesive (Medipore™ Dress-it)) on sternal wound
1107710|NCT00545441|B3|Baseline|Total|Total of all reporting groups
1107711|NCT00545441|B2|Baseline|Flap|Flap: Advancement flap surgery is performed; no anal fistula plug is placed
1107713|NCT00545441|P2|Participant Flow|Flap|Flap: Advancement flap surgery is performed; no anal fistula plug is placed
1107718|NCT00545441|E1|Reported Event|Surgisis® AFP|Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP): Surgical placement of the Surgisis AFP is performed under general anesthesia.
1107719|NCT00545402|B3|Baseline|Total|Total of all reporting groups
1107720|NCT00545402|B2|Baseline|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
1107721|NCT00545402|B1|Baseline|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
1107722|NCT00545402|P2|Participant Flow|Fixed-Dose MMF + Tacrolimus + Corticosteroid (CS)|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
1107781|NCT00545272|P1|Participant Flow|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107782|NCT00545272|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1108246|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
1107723|NCT00545402|P1|Participant Flow|Adjusted Mycophenolate Mofetil (MMF)+Tacrolimus+Corticosteroid|Participants received MMF tablets or capsules, 3 grams per day (g/d), orally (PO), twice daily (BID) with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (area under the concentration-time curve [AUC]) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 nanograms per milliliter (ng/mL) from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an intravenous (IV) bolus of methylprednisolone 10-15 milligrams per kilogram (mg/kg) pre-operative on Day 0 per standard practice of the center.
1107724|NCT00545402|O2|Outcome|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
1107725|NCT00545402|O1|Outcome|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
1107726|NCT00545402|O2|Outcome|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
1107727|NCT00545402|O1|Outcome|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
1107728|NCT00545402|O2|Outcome|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
1107761|NCT00545298|O2|Outcome|B - Same Treatment for 6 Weeks|200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound
1107762|NCT00545298|O1|Outcome|A - Standard of Care (Control)|Standard of care - dressings and sustained compression only
1107729|NCT00545402|O1|Outcome|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
1107730|NCT00545402|O2|Outcome|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
1107731|NCT00545402|O1|Outcome|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
1107732|NCT00545402|O2|Outcome|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
1107783|NCT00545272|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
1107784|NCT00545272|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1108247|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
1107733|NCT00545402|O1|Outcome|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
1107734|NCT00545402|O2|Outcome|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
1107735|NCT00545402|O1|Outcome|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
1107736|NCT00545402|E2|Reported Event|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
1107737|NCT00545402|E1|Reported Event|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
1107738|NCT00545363|B3|Baseline|Total|Total of all reporting groups
1107739|NCT00545363|B2|Baseline|No BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake.
1107763|NCT00545298|O3|Outcome|C - Modified Treatment, 5 Wks Lower Dose|200 ppm NO gas 8 hrs / day 1 wk, 20ppm 8 hrs / day 5 weeks. Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
1107764|NCT00545298|O2|Outcome|A - Standard of Care (Control)|Standard of Care - dressings and sustained compression only
1107944|NCT00545103|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
1107740|NCT00545363|B1|Baseline|BMF Participants|"Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A BMF-form” was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake."
1107741|NCT00545363|P2|Participant Flow|No BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake.
1107742|NCT00545363|P1|Participant Flow|Bone Marker Feedback (BMF) Participants|"Postmenopausal women received ibandronate 150 milligrams (mg) once monthly (QM) orally for 6 months. Participants, in this arm, received bone marker feedback (BMF) at Month 3. BMF was given in terms of providing serum carboxy-terminal collagen crosslinks (CTX) level at Month 3. A BMF-form” was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by patient relationship program (PRP), carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake."
1107743|NCT00545363|O2|Outcome|No BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake.
1107744|NCT00545363|O1|Outcome|BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A “BMF-form” was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake.
1107745|NCT00545363|O2|Outcome|No BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake.
1107746|NCT00545363|O1|Outcome|BMF Participants|"Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A BMF-form” was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake."
1107747|NCT00545363|O2|Outcome|No BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake.
1108248|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
1107748|NCT00545363|O1|Outcome|BMF Participants|"Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A BMF-form” was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake."
1107749|NCT00545363|O2|Outcome|No BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake.
1107750|NCT00545363|O1|Outcome|BMF Participants|"Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A BMF-form” was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake."
1107751|NCT00545363|E2|Reported Event|No BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake.
1107752|NCT00545363|E1|Reported Event|BMF Participants|"Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A BMF-form” was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake."
1107753|NCT00545298|B4|Baseline|Total|Total of all reporting groups
1107754|NCT00545298|B3|Baseline|C - Modified Treatment, 5 Wks Lower Dose|200 ppm No gas 8 hrs/day 1 wk, 20ppm 8hrs/day 5 weeks Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
1107755|NCT00545298|B2|Baseline|B Same Treatment for 6 Weeks|200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound
1107756|NCT00545298|B1|Baseline|A - Standard of Care (Control)|Standard of care - dressings and sustained compression only
1107757|NCT00545298|P3|Participant Flow|C - Modified Treatment, 5 Wks Lower Dose|200 ppm No gas 8 hrs/day 1 wk, 20ppm 8hrs/day 5 weeks Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
1107758|NCT00545298|P2|Participant Flow|B - Same Treatment for 6 Weeks|200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound
1107759|NCT00545298|P1|Participant Flow|A - Standard of Care (Control)|Standard of care - dressings and sustained compression only
1107760|NCT00545298|O3|Outcome|C - Modified Treatment, 5 Wks Lower Dose|200 ppm No gas 8 hrs/day 1 wk, 20ppm 8hrs/day 5 weeks Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
1107939|NCT00545103|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
1107765|NCT00545298|O1|Outcome|B - Same Treatment for 6 Weeks|This group received 200ppm NO in Nitrogen delivered constantly to a patch over the wound for 8 hours per day for 6 weeks
1107766|NCT00545298|E3|Reported Event|C - Modified Treatment, 5 Wks Lower Dose|200 ppm No gas 8 hrs/day 1 wk, 20ppm 8hrs/day 5 weeks Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
1107767|NCT00545298|E2|Reported Event|B Same Treatment for 6 Weeks|200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound
1107768|NCT00545298|E1|Reported Event|A - Standard of Care (Control)|Standard of care - dressings and sustained compression only
1107769|NCT00545272|B7|Baseline|Total|Total of all reporting groups
1107770|NCT00545272|B6|Baseline|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107771|NCT00545272|B5|Baseline|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
1107772|NCT00545272|B4|Baseline|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107773|NCT00545272|B3|Baseline|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107774|NCT00545272|B2|Baseline|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107775|NCT00545272|B1|Baseline|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107776|NCT00545272|P6|Participant Flow|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107777|NCT00545272|P5|Participant Flow|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
1107778|NCT00545272|P4|Participant Flow|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107779|NCT00545272|P3|Participant Flow|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107780|NCT00545272|P2|Participant Flow|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107789|NCT00545272|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
1107790|NCT00545272|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107791|NCT00545272|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107792|NCT00545272|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107793|NCT00545272|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107794|NCT00545272|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107795|NCT00545272|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
1107796|NCT00545272|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107797|NCT00545272|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107798|NCT00545272|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107799|NCT00545272|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107800|NCT00545272|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107801|NCT00545272|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
1107802|NCT00545272|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107803|NCT00545272|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107804|NCT00545272|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107805|NCT00545272|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107806|NCT00545272|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107807|NCT00545272|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
1107808|NCT00545272|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107809|NCT00545272|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107810|NCT00545272|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107811|NCT00545272|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107812|NCT00545272|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107813|NCT00545272|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
1107814|NCT00545272|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107815|NCT00545272|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107816|NCT00545272|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107817|NCT00545272|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107818|NCT00545272|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107819|NCT00545272|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
1107820|NCT00545272|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107821|NCT00545272|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107822|NCT00545272|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107823|NCT00545272|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107824|NCT00545272|E6|Reported Event|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107825|NCT00545272|E5|Reported Event|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
1107826|NCT00545272|E4|Reported Event|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107827|NCT00545272|E3|Reported Event|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107828|NCT00545272|E2|Reported Event|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107829|NCT00545272|E1|Reported Event|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
1107830|NCT00545233|B3|Baseline|Total|Total of all reporting groups
1107831|NCT00545233|B2|Baseline|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
1107832|NCT00545233|B1|Baseline|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
1107833|NCT00545233|P2|Participant Flow|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
1107834|NCT00545233|P1|Participant Flow|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
1107835|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
1107836|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
1107940|NCT00545103|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
1107837|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
1107838|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
1107839|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
1107840|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
1107841|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
1107842|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
1108249|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
1107843|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
1107844|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
1107845|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
1107846|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
1107847|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
1107848|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
1107849|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
1107850|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
1107941|NCT00545103|O4|Outcome|Placebo|Placebo administered orally once daily
1107851|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
1107852|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
1107853|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
1107854|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
1107855|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
1107856|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
1107900|NCT00545168|O1|Outcome|A/B - NatrOVA 1% - With/Without Nit Combing|NatrOVA Creme Rinse (spinosad) 1% - With or without nit combing required
1108250|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
1107857|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
1107858|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
1107859|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
1107860|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
1107861|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
1107862|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
1107863|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received piogliatzone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a) subcutaneous (sc) once a week plus ribavirin (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of piogliatzone per day orally in the 24 week follow-up period.
1107864|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
1107865|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
1107866|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
1107867|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
1107868|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
1107869|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
1107870|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
1107901|NCT00545168|E2|Reported Event|C - NIX|Nix Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC) Instructions for Use
1108251|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
1107871|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
1107872|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
1107873|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
1107874|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
1107875|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
1107876|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
1107877|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
1107878|NCT00545233|E2|Reported Event|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
1107879|NCT00545233|E1|Reported Event|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
1107880|NCT00545181|B3|Baseline|Total|Total of all reporting groups
1107881|NCT00545181|B2|Baseline|Metronidazole Alone|Metronidazole antibiotic therapy alone
1107882|NCT00545181|B1|Baseline|Metronidazole + Acidifying Gel (RepHresh)|Receive metronidazole plus vaginal acidifying gel
1107883|NCT00545181|P2|Participant Flow|Metronidazole Alone|Metronidazole antibiotic therapy alone
1107884|NCT00545181|P1|Participant Flow|Metronidazole + Acidifying Gel (RepHresh)|Receive metronidazole plus vaginal acidifying gel
1107885|NCT00545181|O2|Outcome|Metronidazole Alone|Metronidazole antibiotic therapy alone
1107886|NCT00545181|O1|Outcome|Metronidazole + Acidifying Gel (RepHresh)|Receive metronidazole plus vaginal acidifying gel
1107887|NCT00545181|E2|Reported Event|Metronidazole Alone|Metronidazole antibiotic therapy alone
1107888|NCT00545181|E1|Reported Event|Metronidazole + Acidifying Gel (RepHresh)|Receive metronidazole plus vaginal acidifying gel
1107889|NCT00545168|B4|Baseline|Total|Total of all reporting groups
1107890|NCT00545168|B3|Baseline|C - NIX|Nix Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC) Instructions for Use
1107891|NCT00545168|B2|Baseline|B - NatrOVA 1% - Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required
1107892|NCT00545168|B1|Baseline|A - NatrOVA 1% - no Nit Combing|NatrOVA Creme Rinse (spinosad) 1% - no nit combing required Spinosad
1107893|NCT00545168|P3|Participant Flow|C - NIX|NIX Creme Rinse (permethrin 1%) applied to Over the Counter (OTC) Instructions for Use
1107894|NCT00545168|P2|Participant Flow|B - NatrOVA 1% - Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required
1107895|NCT00545168|P1|Participant Flow|A - NatrOVA 1% - no Nit Combing|NatrOVA Creme Rinse (spinosad) 1% - no nit combing required Spinosad
1107896|NCT00545168|O3|Outcome|C - NIX|Nix Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC) Instructions for Use
1107897|NCT00545168|O2|Outcome|B - NatrOVA 1% - Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required
1107898|NCT00545168|O1|Outcome|A - NatrOVA 1% - no Nit Combing|NatrOVA Creme Rinse (spinosad) 1% - no nit combing required Spinosad
1107899|NCT00545168|O2|Outcome|C - NIX|Nix Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC) Instructions for Use
1107902|NCT00545168|E1|Reported Event|A/B - NatrOVA 1% - With/Without Nit Combing|NatrOVA Creme Rinse (spinosad) 1% - With or without nit combing required
1107903|NCT00545155|B1|Baseline|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
1107904|NCT00545155|P1|Participant Flow|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
1107905|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
1107906|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
1107907|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
1107908|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
1107909|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
1107910|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
1107911|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
1107912|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
1107913|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
1107914|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
1107915|NCT00545155|E1|Reported Event|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
1107916|NCT00545103|B5|Baseline|Total|Total of all reporting groups
1107917|NCT00545103|B4|Baseline|Placebo|Placebo administered orally once daily
1107918|NCT00545103|B3|Baseline|SPD476 (4.8 g)|4.8 g administered orally once daily
1107919|NCT00545103|B2|Baseline|SPD476 (2.4 g)|2.4 g administered orally once daily
1107920|NCT00545103|B1|Baseline|SPD476 (1.2 g)|1.2 g administered orally once daily
1107921|NCT00545103|P4|Participant Flow|Placebo|Placebo administered orally once daily
1107922|NCT00545103|P3|Participant Flow|SPD476 (4.8 g)|4.8 g administered orally once daily
1107923|NCT00545103|P2|Participant Flow|SPD476 (2.4 g)|2.4 g administered orally once daily
1107924|NCT00545103|P1|Participant Flow|SPD476 (1.2 g)|1.2 g administered orally once daily
1107925|NCT00545103|O4|Outcome|Placebo|Placebo administered orally once daily
1107926|NCT00545103|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
1107927|NCT00545103|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
1107928|NCT00545103|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
1107929|NCT00545103|O4|Outcome|Placebo|Placebo administered orally once daily
1107930|NCT00545103|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
1107931|NCT00545103|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
1107932|NCT00545103|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
1107933|NCT00545103|O4|Outcome|Placebo|Placebo administered orally once daily
1107934|NCT00545103|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
1107935|NCT00545103|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
1107936|NCT00545103|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
1107937|NCT00545103|O4|Outcome|Placebo|Placebo administered orally once daily
1107938|NCT00545103|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
1107945|NCT00545103|O4|Outcome|Placebo|Placebo administered orally once daily
1107946|NCT00545103|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
1107947|NCT00545103|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
1107948|NCT00545103|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
1107949|NCT00545103|O4|Outcome|Placebo|Placebo administered orally once daily
1107950|NCT00545103|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
1107951|NCT00545103|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
1107952|NCT00545103|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
1107953|NCT00545103|E4|Reported Event|Placebo|Placebo administered orally once daily
1107954|NCT00545103|E3|Reported Event|SPD476 (4.8 g)|4.8 g administered orally once daily
1107955|NCT00545103|E2|Reported Event|SPD476 (2.4 g)|2.4 g administered orally once daily
1107956|NCT00545103|E1|Reported Event|SPD476 (1.2 g)|1.2 g administered orally once daily
1107957|NCT00545064|B1|Baseline|Preservative-free Dorzolamide-timolol (COSOPT®)|"subjects received preservative-free dorzolamide-timolol (COSOPT®) administered one drop in the affected eye two times daily~The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristircs were available)."
1107958|NCT00545064|P1|Participant Flow|Preservative-free Dorzolamide-timolol (COSOPT®)|"subjects received preservative-free dorzolamide-timolol (COSOPT®) administered one drop in the affected eye two times daily~The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristircs were available)."
1107959|NCT00545064|O2|Outcome|Preservative-free Dorzolamide-timolol (COSOPT®) Week 8|
1107960|NCT00545064|O1|Outcome|Preservative-free Dorzolamide-timolol (COSOPT®) Week 4|
1107961|NCT00545064|O1|Outcome|Preservative-free COSOPT® at Week 8|
1107962|NCT00545064|O1|Outcome|Preservative-free COSOPT® at Week 8|
1107963|NCT00545064|O2|Outcome|Preservative-free Dorzolamide-timolol (COSOPT®) Week 8|
1107964|NCT00545064|O1|Outcome|Preservative-free Dorzolamide-timolol (COSOPT®) Week 4|
1108252|NCT00543725|E2|Reported Event|Efavirenz|600 mg once daily
1107965|NCT00545064|E1|Reported Event|Preservative-free Dorzolamide-timolol (COSOPT®)|"subjects received preservative-free dorzolamide-timolol (COSOPT®) administered one drop in the affected eye two times daily~The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristircs were available)."
1107966|NCT00545051|B3|Baseline|Total|Total of all reporting groups
1107967|NCT00545051|B2|Baseline|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
1107968|NCT00545051|B1|Baseline|Ibandronate|Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
1107969|NCT00545051|P2|Participant Flow|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
1107970|NCT00545051|P1|Participant Flow|Ibandronate|Participants received 150 milligram (mg) ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 International Units (IU) Vitamin D per day.
1107971|NCT00545051|O2|Outcome|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
1107972|NCT00545051|O1|Outcome|Ibandronate|Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
1107973|NCT00545051|O2|Outcome|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
1107974|NCT00545051|O1|Outcome|Ibandronate|Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
1107975|NCT00545051|O2|Outcome|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
1107976|NCT00545051|O1|Outcome|Ibandronate|Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
1107977|NCT00545051|O2|Outcome|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
1107978|NCT00545051|O1|Outcome|Ibandronate|Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
1107979|NCT00545051|O2|Outcome|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
1107980|NCT00545051|O1|Outcome|Ibandronate|Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
1107981|NCT00545051|E2|Reported Event|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
1107982|NCT00545051|E1|Reported Event|Ibandronate|Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
1107983|NCT00545025|B3|Baseline|Total|Total of all reporting groups
1107984|NCT00545025|B2|Baseline|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
1108098|NCT00544648|B2|Baseline|Phase II|MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
1107985|NCT00545025|B1|Baseline|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
1107986|NCT00545025|P2|Participant Flow|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
1107987|NCT00545025|P1|Participant Flow|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
1107988|NCT00545025|O2|Outcome|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
1107989|NCT00545025|O1|Outcome|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
1107990|NCT00545025|O2|Outcome|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
1108072|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
1107991|NCT00545025|O1|Outcome|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
1107992|NCT00545025|O2|Outcome|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
1107993|NCT00545025|O1|Outcome|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
1107994|NCT00545025|O2|Outcome|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
1107995|NCT00545025|O1|Outcome|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
1107996|NCT00545025|O2|Outcome|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
1107997|NCT00545025|O1|Outcome|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
1107998|NCT00545025|O2|Outcome|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
1108099|NCT00544648|B1|Baseline|Phase I|Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 weekly for 7 weeks with concurrent radiotherapy
1108501|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
1114307|NCT00529542|O2|Outcome|Placebo|Placebo qd
1107999|NCT00545025|O1|Outcome|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
1108000|NCT00545025|O2|Outcome|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
1108001|NCT00545025|O1|Outcome|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
1108002|NCT00545025|O2|Outcome|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
1108003|NCT00545025|O1|Outcome|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
1108004|NCT00545025|E2|Reported Event|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
1108073|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
1108074|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
1108075|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
1108253|NCT00543725|E1|Reported Event|TMC278|25 mg tablet once daily
1108005|NCT00545025|E1|Reported Event|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine adjuvanted with a full dose of AS03-adjuvant in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03- adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
1108006|NCT00544908|B1|Baseline|Dasatinib|Dasatinib 70 mg po bid (1 cycle=28 days)
1108007|NCT00544908|P1|Participant Flow|Dasatinib|Dasatinib 70 mg po bid (1 cycle=28 days)
1108008|NCT00544908|O1|Outcome|Dasatinib|Dasatinib 70 mg po bid (1 cycle=28 days)
1108009|NCT00544908|O1|Outcome|Dasatinib|Dasatinib 70 mg po bid (1 cycle=28 days)
1108010|NCT00544908|E1|Reported Event|Dasatinib|Dasatinib 70 mg po bid (1 cycle=28 days)
1108011|NCT00544882|B3|Baseline|Total|Total of all reporting groups
1108012|NCT00544882|B2|Baseline|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
1108013|NCT00544882|B1|Baseline|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
1108014|NCT00544882|P3|Participant Flow|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
1108015|NCT00544882|P2|Participant Flow|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
1108016|NCT00544882|P1|Participant Flow|Run-In Cycle - All Enrolled|After completing screening, all enrolled participants received the same regimen of 150 μg Desogestrel (DSG) /20 μg Ethinyl Estradiol (EE) combination pills once daily for 21 days followed by placebo once daily for 7 days during Cycle 1.
1108502|NCT00542828|E1|Reported Event|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
1108017|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
1108018|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
1108019|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
1108020|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
1108021|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
1108022|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
1108076|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
1108254|NCT00543569|B5|Baseline|Total|Total of all reporting groups
1108023|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
1108024|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
1108025|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
1108026|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
1108027|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
1108028|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
1108120|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
1108029|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
1108030|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
1108031|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
1108032|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
1108033|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
1108034|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
1108035|NCT00544882|E2|Reported Event|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
1108036|NCT00544882|E1|Reported Event|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
1108037|NCT00544869|B4|Baseline|Total|Total of all reporting groups
1108038|NCT00544869|B3|Baseline|Dose Escalated to 30 mg/Day|Subsequent 7-day repeated administration of OPC-41061 at 30 mg/day (treatment period 2)
1108039|NCT00544869|B2|Baseline|Continued at 15 mg/Day|Subsequent 7-day repeated administration of OPC-41061 at 15 mg/day (treatment period 2)
1108040|NCT00544869|B1|Baseline|Stopped at End of Treatment Period 1|Administration of OPC-41061 at 15 mg/day (treatment period 1) for 7 days
1108041|NCT00544869|P3|Participant Flow|Dose Escalated to 30 mg/Day|Subsequent 7-day repeated administration of OPC-41061 at 30 mg/day (treatment period 2)
1108042|NCT00544869|P2|Participant Flow|Continued at 15 mg/Day|Subsequent 7-day repeated administration of OPC-41061 at 15 mg/day (treatment period 2)
1108043|NCT00544869|P1|Participant Flow|Stopped at End of Treatment Period 1|Administration of OPC-41061 at 15 mg/day (treatment period 1) for 7 days
1108044|NCT00544869|O3|Outcome|Dose Escalated to 30 mg/Day|
1108045|NCT00544869|O2|Outcome|Continued at 15 mg/Day|
1108046|NCT00544869|O1|Outcome|Stopped at End of Treatment Period 1|
1108047|NCT00544869|E3|Reported Event|Dose Escalated to 30 mg/Day|Subsequent 7-day repeated administration of OPC-41061 at 30 mg/day (treatment period 2)
1108048|NCT00544869|E2|Reported Event|Continued at 15 mg/Day|Subsequent 7-day repeated administration of OPC-41061 at 15 mg/day (treatment period 2)
1108049|NCT00544869|E1|Reported Event|Stopped at End of Treatment Period 1|Administration of OPC-41061 at 15 mg/day (treatment period 1) for 7 days
1108050|NCT00544817|B1|Baseline|Combination Therapy|"In the combined modality portion of the study, patients were administered:~Radiation Therapy - 2 Gy/fraction, Single daily fractions M-F, to 60 Gy total Temozolomide - 75 mg/m2 by mouth once daily~Patients took a four week break before beginning follow-up systemic therapy:~Temozolomide - 150 mg /m2 by mouth on days 1-5 every 28 days for 6 cycles Sorafenib - 400 mg by mouth twice a day for 6 months"
1108051|NCT00544817|P1|Participant Flow|Combination Therapy|"In the combined modality portion of the study, patients were administered:~Radiation Therapy - 2 Gy/fraction, Single daily fractions M-F, to 60 Gy total Temozolomide - 75 mg/m2 by mouth once daily~Patients took a four week break before beginning follow-up systemic therapy:~Temozolomide - 150 mg /m2 by mouth on days 1-5 every 28 days for 6 cycles Sorafenib - 400 mg by mouth twice a day for 6 months"
1108174|NCT00543855|B5|Baseline|Total|Total of all reporting groups
1108503|NCT00542815|B4|Baseline|Total|Total of all reporting groups
1108052|NCT00544817|O1|Outcome|Combination Therapy|"In the combined modality portion of the study, patients were administered:~Radiation Therapy - 2 Gy/fraction, Single daily fractions M-F, to 60 Gy total Temozolomide - 75 mg/m2 by mouth once daily~Patients took a four week break before beginning follow-up systemic therapy:~Temozolomide - 150 mg /m2 by mouth on days 1-5 every 28 days for 6 cycles Sorafenib - 400 mg by mouth twice a day for 6 months"
1108053|NCT00544817|O1|Outcome|Combination Therapy|"In the combined modality portion of the study, patients were administered:~Radiation Therapy - 2 Gy/fraction, Single daily fractions M-F, to 60 Gy total Temozolomide - 75 mg/m2 by mouth once daily~Patients took a four week break before beginning follow-up systemic therapy:~Temozolomide - 150 mg /m2 by mouth on days 1-5 every 28 days for 6 cycles Sorafenib - 400 mg by mouth twice a day for 6 months"
1108054|NCT00544817|O1|Outcome|Combination Therapy|"In the combined modality portion of the study, patients were administered:~Radiation Therapy - 2 Gy/fraction, Single daily fractions M-F, to 60 Gy total Temozolomide - 75 mg/m2 by mouth once daily~Patients took a four week break before beginning follow-up systemic therapy:~Temozolomide - 150 mg /m2 by mouth on days 1-5 every 28 days for 6 cycles Sorafenib - 400 mg by mouth twice a day for 6 months"
1108055|NCT00544817|E1|Reported Event|Combination Therapy|"In the combined modality portion of the study, patients were administered:~Radiation Therapy - 2 Gy/fraction, Single daily fractions M-F, to 60 Gy total Temozolomide - 75 mg/m2 by mouth once daily~Patients took a four week break before beginning follow-up systemic therapy:~Temozolomide - 150 mg /m2 by mouth on days 1-5 every 28 days for 6 cycles Sorafenib - 400 mg by mouth twice a day for 6 months"
1108056|NCT00544778|B1|Baseline|Arm 1|High-dose chemotherapy with doxorubicin at 120 mg/m2 and ifosfamide at 2 g/m2 followed by a prolonged schedule of CPT-11 at 20 mg/m2.
1108057|NCT00544778|P1|Participant Flow|Arm 1|High-dose chemotherapy with doxorubicin at 120 mg/m2 and ifosfamide at 2 g/m2 followed by a prolonged schedule of CPT-11 at 20 mg/m2.
1108058|NCT00544778|O1|Outcome|Arm 1|High-dose chemotherapy with doxorubicin at 120 mg/m2 and ifosfamide at 2 g/m2 followed by a prolonged schedule of CPT-11 at 20 mg/m2.
1108059|NCT00544778|E1|Reported Event|Arm 1|High-dose chemotherapy with doxorubicin at 120 mg/m2 and ifosfamide at 2 g/m2 followed by a prolonged schedule of CPT-11 at 20 mg/m2.
1108060|NCT00544713|B3|Baseline|Total|Total of all reporting groups
1108061|NCT00544713|B2|Baseline|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
1108062|NCT00544713|B1|Baseline|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
1108063|NCT00544713|P2|Participant Flow|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
1108064|NCT00544713|P1|Participant Flow|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
1108065|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
1108066|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
1108067|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
1108068|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
1108069|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
1108070|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
1108071|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
1108078|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
1108079|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
1108080|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
1108081|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
1108082|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
1108083|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
1108084|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
1108085|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
1108086|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
1108087|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
1108088|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
1108089|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
1108090|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
1108091|NCT00544713|E2|Reported Event|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
1108092|NCT00544713|E1|Reported Event|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
1108093|NCT00544674|B1|Baseline|PR104|1100 mg/m^2 PR104 by IV over one hour every three weeks
1108094|NCT00544674|P1|Participant Flow|PR104|Subjects will receive 1100 mg/m^2 PR-104 intravenously once every 21 days (one cycle). In addition, subjects will undergo positron emission topography (PET) imaging with F-18-Fluoro Misonidazole (FMISO) for the assessment of hypoxia and with F-18-Fluorodeoxyglucose (FDG) for the assessment of glucose metabolism.
1108095|NCT00544674|O1|Outcome|PR104|1100 mg/m^2 PR104 by IV over one hour every three weeks
1108096|NCT00544674|E1|Reported Event|PR104|1100 mg/m^2 PR104 by IV over one hour every three weeks
1108097|NCT00544648|B3|Baseline|Total|Total of all reporting groups
1108213|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
1108100|NCT00544648|P2|Participant Flow|Phase II|MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
1108101|NCT00544648|P1|Participant Flow|Phase I|Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 weekly for 7 weeks with concurrent radiotherapy
1108102|NCT00544648|O1|Outcome|Phase I and Phase II|"Phase I-Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.~Phase II-MTD Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.~Phase II-"
1108103|NCT00544648|O1|Outcome|Phase II|MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
1108104|NCT00544648|O1|Outcome|Phase II|MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
1108105|NCT00544648|O1|Outcome|Phase II|MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
1108106|NCT00544648|O1|Outcome|Phase I|Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 with concurrent radiotherapy
1108107|NCT00544648|O1|Outcome|Phase I|Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 weekly for 7 weeks with concurrent radiotherapy
1108108|NCT00544648|O1|Outcome|Phase I|Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 weekly for 7 weeks with concurrent radiotherapy
1108109|NCT00544648|O1|Outcome|Phase I|Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 weekly for 7 weeks with concurrent radiotherapy
1108110|NCT00544648|O1|Outcome|Phase II|MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
1108465|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
1108111|NCT00544648|O1|Outcome|Phase I|Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 weekly for 7 weeks with concurrent radiotherapy
1108112|NCT00544648|E2|Reported Event|Phase II|MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
1108113|NCT00544648|E1|Reported Event|Phase I|Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
1108114|NCT00544557|B1|Baseline|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
1108115|NCT00544557|P1|Participant Flow|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
1108116|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
1108117|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
1108118|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
1108119|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
1108175|NCT00543855|B4|Baseline|Placebo|"Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
1108121|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
1108122|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
1108123|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
1108124|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
1108125|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
1108126|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
1108127|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
1108128|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
1108129|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
1108130|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
1108131|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
1108132|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
1108133|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
1108134|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
1108135|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
1108136|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
1108137|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
1108138|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
1108139|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
1108191|NCT00543855|O4|Outcome|Placebo|"Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
1108140|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
1108141|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
1108142|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
1108143|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
1108144|NCT00544557|E1|Reported Event|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
1108145|NCT00544544|B1|Baseline|Riluzole|Riluzole 100-200 mg/day
1108146|NCT00544544|P1|Participant Flow|Riluzole|Riluzole 100-200 mg/day
1108147|NCT00544544|O1|Outcome|Riluzole|Riluzole 100-200 mg/day
1108148|NCT00544544|E1|Reported Event|Riluzole|Riluzole 100-200 mg/day
1108149|NCT00544440|B1|Baseline|Abiraterone Acetate|Patients were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
1108150|NCT00544440|P1|Participant Flow|Abiraterone Acetate|Patients were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
1108151|NCT00544440|O1|Outcome|Abiraterone Acetate|Participants were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
1108152|NCT00544440|O1|Outcome|Abiraterone Acetate|Participants were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
1108153|NCT00544440|O1|Outcome|Abiraterone Acetate|Participants were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
1108154|NCT00544440|O1|Outcome|Abiraterone Acetate|Participants were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
1108155|NCT00544440|E1|Reported Event|Abiraterone Acetate|Patients were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
1108156|NCT00544167|B1|Baseline|Doxorubicin/Cyclophosphamide Then Paclitaxel/Sorafenib|Doxorubicin 60mg/m2 IV, Cyclophosphamide 600mg/m2 IV every 3 weeks for a total of 12 weeks followed by 12 weeks of paclitaxel (either 175mg/m2 IV every three weeks or 80mg/m2 IV weekly) and sorafenib 400mg twice daily by mouth (up to a maximum of 1 year).
1108157|NCT00544167|P1|Participant Flow|Doxorubicin/Cyclophosphamide Then Paclitaxel/Sorafenib|All patients received doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 (AC) both administered intravenously day 1 every 3 weeks for four cycles, followed by paclitaxel 175 mg/m2 intravenously day 1 every 3 weeks for four cycles or 80 mg/m2 for twelve weeks (physician discretion), combined with sorafenib 400 mg orally twice daily. Sorafenib was held during radiation therapy where indicated and resumed once completed. Sorafenib was continued for a total of 12 months and in combination with adjuvant hormonal therapy where indicated.
1108158|NCT00544167|O1|Outcome|Doxorubicin/Cyclophosphamide Then Paclitaxel/Sorafenib|
1108159|NCT00544167|E1|Reported Event|Doxorubicin/Cyclophosphamide Then Paclitaxel/Sorafenib|All patients received doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 (AC) both administered intravenously day 1 every 3 weeks for four cycles, followed by paclitaxel 175 mg/m2 intravenously day 1 every 3 weeks for four cycles or 80 mg/m2 for twelve weeks (physician discretion), combined with sorafenib 400 mg orally twice daily. Sorafenib was held during radiation therapy where indicated and resumed once completed. Sorafenib was continued for a total of 12 months and in combination with adjuvant hormonal therapy where indicated.
1108160|NCT00543296|B1|Baseline|0.59 mg Fluocinolone Acetonide Implant|
1108161|NCT00543296|P1|Participant Flow|0.59 mg Fluocinolone Acetonide Implant|
1108162|NCT00543296|O1|Outcome|0.59 mg Fluocinolone Acetonide Implant|
1108163|NCT00543296|O1|Outcome|0.59 mg Fluocinolone Acetonide Implant|
1108164|NCT00543296|O1|Outcome|0.59 mg Fluocinolone Acetonide Implant|
1108165|NCT00543296|O1|Outcome|0.59 mg Fluocinolone Acetonide Implant|
1108166|NCT00543296|E1|Reported Event|0.59 mg Fluocinolone Acetonide Implant|
1108167|NCT00543985|B1|Baseline|Stress Echocardiography|Patients completed 3 months of training with 10% weight loss. At the end of that study, they were subjected to pre- and post-stress echocardiography to evaluate E/E' and VO2 max.
1108168|NCT00543985|P1|Participant Flow|Stress Echocardiography|Echocardiography was performed prior to and within 60 seconds of completing the standard Bruce treadmill protocol.
1108169|NCT00543985|O1|Outcome|Stress Echocardiography|Echocardiography was performed prior to and within 60 seconds of completing the standard Bruce treadmill protocol.
1108170|NCT00543985|O1|Outcome|Stress Echocardiography|"Echocardiography was performed prior to and within 60 seconds of completing the standard Bruce treadmill protocol.~Stress Echocardiography: Echocardiography was performs prior to and within 60 seconds of completing the standard Bruce treadmill protocol."
1108171|NCT00543985|O1|Outcome|Stress Echocardiography|Echocardiogram E/E' measured after exercise
1108172|NCT00543985|O1|Outcome|Stress Echocardiography|Echocardiogram E/E' measured before and after exercise
1108173|NCT00543985|E1|Reported Event|Stress Echocardiography|Patients completed 3 months of training with 10% weight loss. At the end of that study, they were subjected to pre- and post-stress echocardiography to evaluate E/E' .
1108176|NCT00543855|B3|Baseline|10 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).~Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks)."
1108177|NCT00543855|B2|Baseline|5 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
1108178|NCT00543855|B1|Baseline|3 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
1108179|NCT00543855|P4|Participant Flow|Placebo|"Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
1108180|NCT00543855|P3|Participant Flow|10 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).~Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43 - Day 84 (6 weeks)."
1108181|NCT00543855|P2|Participant Flow|5 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
1108182|NCT00543855|P1|Participant Flow|3 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
1108379|NCT00543543|O1|Outcome|Low-dose V503|V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study Part A.
1108466|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
1108183|NCT00543855|O4|Outcome|Placebo|"Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
1108184|NCT00543855|O3|Outcome|10 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).~Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks)."
1108185|NCT00543855|O2|Outcome|5 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
1108186|NCT00543855|O1|Outcome|3 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
1108187|NCT00543855|O4|Outcome|Placebo|"Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
1108188|NCT00543855|O3|Outcome|10 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).~Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks)."
1108189|NCT00543855|O2|Outcome|5 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
1108190|NCT00543855|O1|Outcome|3 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
1114308|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
1108192|NCT00543855|O3|Outcome|10 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).~Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks)."
1108193|NCT00543855|O2|Outcome|5 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
1108194|NCT00543855|O1|Outcome|3 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
1108195|NCT00543855|O4|Outcome|Placebo|"Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
1108196|NCT00543855|O3|Outcome|10 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).~Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks)."
1108197|NCT00543855|O2|Outcome|5 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
1108198|NCT00543855|O1|Outcome|3 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
1108532|NCT00542620|B3|Baseline|Total|Total of all reporting groups
1108199|NCT00543855|E4|Reported Event|Placebo|"Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
1108200|NCT00543855|E3|Reported Event|10 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).~Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks)."
1108201|NCT00543855|E2|Reported Event|5 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
1108202|NCT00543855|E1|Reported Event|3 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
1108203|NCT00543803|B1|Baseline|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
1108204|NCT00543803|P1|Participant Flow|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
1108205|NCT00543803|O2|Outcome|Last Evaluation Assessment on Treatment|Patients treated with Viramune in combination with Truvada (Investigators opinion of patients general health condition at last evaluation on treatment within 36 months)
1108206|NCT00543803|O1|Outcome|Evaluation Assessment at Baseline|Patients treated with Viramune in combination with Truvada (Investigators opinion of patients general health condition at baseline)
1108207|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
1108208|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
1108209|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
1108210|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
1108211|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
1108212|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
1108504|NCT00542815|B3|Baseline|Sevelamer From E07 Study|2.4, 4.8, 7.2, 9.6, or 12.0g / day as titrated
1108214|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
1108215|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
1108216|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
1108217|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
1108218|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
1108219|NCT00543803|E1|Reported Event|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg OD for two weeks, then 200 mg BID, Truvada one tablet QD
1108220|NCT00543764|B3|Baseline|Total|Total of all reporting groups
1108221|NCT00543764|B2|Baseline|Post Pathway|Patients after pathway implementation
1108222|NCT00543764|B1|Baseline|Pre Pathway|Patients prior to pathway implementation
1108223|NCT00543764|P2|Participant Flow|Post Pathway|Patients after pathway implementation
1108224|NCT00543764|P1|Participant Flow|Pre Pathway|Patients prior to pathway implementation
1108225|NCT00543764|O2|Outcome|Post Pathway|Patients after pathway implementation
1108226|NCT00543764|O1|Outcome|Pre Pathway|Patients prior to pathway implementation
1108227|NCT00543764|E2|Reported Event|Post Pathway|Patients after pathway implementation
1108228|NCT00543764|E1|Reported Event|Pre Pathway|Patients prior to pathway implementation
1108229|NCT00543725|B3|Baseline|Total|Total of all reporting groups
1108230|NCT00543725|B2|Baseline|Efavirenz|600 mg once daily
1108231|NCT00543725|B1|Baseline|TMC278|25 mg tablet once daily
1108232|NCT00543725|P2|Participant Flow|Efavirenz|600 mg once daily
1108233|NCT00543725|P1|Participant Flow|TMC278|25 mg tablet once daily
1108234|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
1108235|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
1108236|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
1108237|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
1108238|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
1108239|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
1108240|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
1108241|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
1108242|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
1108243|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
1108244|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
1108245|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
1108255|NCT00543569|B4|Baseline|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
1108256|NCT00543569|B3|Baseline|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
1108257|NCT00543569|B2|Baseline|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
1108258|NCT00543569|B1|Baseline|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
1108259|NCT00543569|P4|Participant Flow|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
1108260|NCT00543569|P3|Participant Flow|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
1108261|NCT00543569|P2|Participant Flow|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
1108262|NCT00543569|P1|Participant Flow|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
1108263|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
1108264|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
1108399|NCT00543543|O1|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. A subset of participants will receive a fourth V503 mid-dose vaccination in the extension study.
1108265|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
1108266|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
1108267|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
1108268|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
1108269|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
1108270|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
1108271|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
1108272|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
1108273|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
1108380|NCT00543543|O4|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. Participants will be offered the V503 mid-dose 3-dose regimen in the extension study.
1108274|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
1108275|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
1108276|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
1108277|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
1108278|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
1108279|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
1108280|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
1108281|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
1108282|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
1108283|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
1108284|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
1108285|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
1108286|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
1108287|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
1108288|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
1108289|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
1108290|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
1108291|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
1108292|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
1108312|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
1108293|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
1108294|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
1108295|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
1108296|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
1108297|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
1108298|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
1108299|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
1108300|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
1108301|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
1108302|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
1108303|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
1108304|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
1108305|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
1108306|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
1108307|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
1108308|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
1108309|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
1108310|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
1108311|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
1108376|NCT00543543|O4|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. Participants will be offered the V503 mid-dose 3-dose regimen in the extension study.
1108313|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
1108314|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
1108315|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
1108316|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
1108317|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
1108318|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
1108319|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
1108320|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
1108321|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
1108322|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
1108323|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
1108324|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
1108325|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
1108326|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
1108327|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
1108328|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
1108329|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
1108330|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
1108331|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
1108377|NCT00543543|O3|Outcome|High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study Part A.
1108461|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
1108332|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
1108333|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
1108334|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
1108335|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
1108336|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
1108337|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
1108338|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
1108339|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
1108340|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
1108341|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
1108342|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
1108343|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
1108344|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
1108345|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
1108346|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
1108347|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
1108348|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
1108349|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
1108350|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
1108378|NCT00543543|O2|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. A subset of participants will receive a fourth V503 mid-dose vaccination in the extension study.
1108631|NCT00542425|O3|Outcome|BA058 40 µg|
1108351|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
1108352|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
1108353|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
1108354|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
1108355|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
1108356|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
1108357|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
1108358|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
1108359|NCT00543569|E4|Reported Event|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
1108360|NCT00543569|E3|Reported Event|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
1108361|NCT00543569|E2|Reported Event|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
1108362|NCT00543569|E1|Reported Event|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
1108363|NCT00543543|B5|Baseline|Total|Total of all reporting groups
1108364|NCT00543543|B4|Baseline|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. Participants will be offered the V503 mid-dose 3-dose regimen in the extension study.
1108365|NCT00543543|B3|Baseline|High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study Part A.
1108366|NCT00543543|B2|Baseline|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. A subset of participants will receive a fourth V503 mid-dose vaccination in the extension study.
1108367|NCT00543543|B1|Baseline|Low-dose V503|V503 (9-Valent Human Papillomavirus [HPV] Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study Part A.
1108368|NCT00543543|P4|Participant Flow|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. Participants will be offered the V503 mid-dose 3-dose regimen in the extension study.
1108369|NCT00543543|P3|Participant Flow|High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study Part A.
1108370|NCT00543543|P2|Participant Flow|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. A subset of participants will receive a fourth V503 mid-dose vaccination in the extension study.
1108371|NCT00543543|P1|Participant Flow|Low-dose V503|V503 (9-Valent Human Papillomavirus [HPV] Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study Part A.
1108372|NCT00543543|O2|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. Participants will be offered the V503 mid-dose 3-dose regimen in the extension study.
1108373|NCT00543543|O1|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. A subset of participants will receive a fourth V503 mid-dose vaccination in the extension study.
1108374|NCT00543543|O2|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. Participants will be offered the V503 mid-dose 3-dose regimen in the extension study.
1108375|NCT00543543|O1|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. A subset of participants will receive a fourth V503 mid-dose vaccination in the extension study.
1108462|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
1108381|NCT00543543|O3|Outcome|High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study Part A.
1108382|NCT00543543|O2|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. A subset of participants will receive a fourth V503 mid-dose vaccination in the extension study.
1108383|NCT00543543|O1|Outcome|Low-dose V503|V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study Part A.
1108384|NCT00543543|O4|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. Participants will be offered the V503 mid-dose 3-dose regimen in the extension study.
1108385|NCT00543543|O3|Outcome|High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study Part A.
1108386|NCT00543543|O2|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. A subset of participants will receive a fourth V503 mid-dose vaccination in the extension study.
1108387|NCT00543543|O1|Outcome|Low-dose V503|V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study Part A.
1108388|NCT00543543|O4|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. Participants will be offered the V503 mid-dose 3-dose regimen in the extension study.
1108389|NCT00543543|O3|Outcome|High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study Part A.
1108390|NCT00543543|O2|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. A subset of participants will receive a fourth V503 mid-dose vaccination in the extension study.
1108391|NCT00543543|O1|Outcome|Low-dose V503|V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study Part A.
1108392|NCT00543543|O4|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. Participants will be offered the V503 mid-dose 3-dose regimen in the extension study.
1108393|NCT00543543|O3|Outcome|High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study Part A.
1108394|NCT00543543|O2|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. A subset of participants will receive a fourth V503 mid-dose vaccination in the extension study.
1108395|NCT00543543|O1|Outcome|Low-dose V503|V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study Part A.
1108396|NCT00543543|O2|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. Participants will be offered the V503 mid-dose 3-dose regimen in the extension study.
1108397|NCT00543543|O1|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. A subset of participants will receive a fourth V503 mid-dose vaccination in the extension study.
1108398|NCT00543543|O2|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. Participants will be offered the V503 mid-dose 3-dose regimen in the extension study.
1108400|NCT00543543|O2|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. Participants will be offered the V503 mid-dose 3-dose regimen in the extension study.
1108401|NCT00543543|O1|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. A subset of participants will receive a fourth V503 mid-dose vaccination in the extension study.
1108402|NCT00543543|E4|Reported Event|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. Participants will be offered the V503 mid-dose 3-dose regimen in the extension study.
1108403|NCT00543543|E3|Reported Event|High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study Part A.
1108404|NCT00543543|E2|Reported Event|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. A subset of participants will receive a fourth V503 mid-dose vaccination in the extension study.
1108405|NCT00543543|E1|Reported Event|Low-Dose V503|V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study Part A.
1108406|NCT00543140|B1|Baseline|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.~Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
1108407|NCT00543140|P1|Participant Flow|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.~Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
1108408|NCT00543140|O1|Outcome|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.~Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
1108409|NCT00543140|O1|Outcome|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.~Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
1108410|NCT00543140|O1|Outcome|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.~Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
1108411|NCT00543140|O1|Outcome|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.~Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
1108412|NCT00543140|O1|Outcome|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.~Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
1108413|NCT00543140|E1|Reported Event|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.~Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
1108414|NCT00543101|B3|Baseline|Total|Total of all reporting groups
1108415|NCT00543101|B2|Baseline|Continue on Current Dual Boosted PI|This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
1108416|NCT00543101|B1|Baseline|Switch to DRV/r|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
1108417|NCT00543101|P2|Participant Flow|Continue on Current Dual Boosted PI|This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
1108418|NCT00543101|P1|Participant Flow|Switch to DRV/r|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
1108419|NCT00543101|O2|Outcome|Crossover Week 48|At week 24 the dual PI arm subjects remaining undetectable, crossed over to the DRV/r arm and were followed for an additional 24 weeks.
1108420|NCT00543101|O1|Outcome|Switch to DRV/r|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
1108421|NCT00543101|O2|Outcome|Continue on Current Dual Boosted PI|This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
1108422|NCT00543101|O1|Outcome|Switch to DRV/r|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
1108423|NCT00543101|O2|Outcome|Continue on Current Dual Boosted PI|This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
1108424|NCT00543101|O1|Outcome|Switch to DRV/r|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
1108425|NCT00543101|O2|Outcome|Continue on Current Dual Boosted PI|This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
1108426|NCT00543101|O1|Outcome|Switch to DRV/r|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
1108427|NCT00543101|E2|Reported Event|Continue on Current Dual Boosted PI|This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
1108428|NCT00543101|E1|Reported Event|Switch to DRV/r|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
1108429|NCT00542997|B1|Baseline|IgPro20 (All Treated)|All subjects enrolled and treated with subcutaneous infusion of IgPro20
1108430|NCT00542997|P1|Participant Flow|IgPro20 (All Treated)|All subjects receiving at least 1 infusion of IgPro20
1108431|NCT00542997|O1|Outcome|IgPro20 (PK Substudy)|Subjects enrolled and treated with subcutaneous infusion of IgPro20 participating in the pharmacokinetic sub-study
1108432|NCT00542997|O1|Outcome|IgPro20 (PK Substudy)|Subjects enrolled and treated with subcutaneous infusion of IgPro20 participating in the pharmacokinetic sub-study
1108433|NCT00542997|O1|Outcome|IgPro20 (PK Substudy)|Subjects enrolled and treated with subcutaneous infusion of IgPro20 participating in the pharmacokinetic sub-study
1108434|NCT00542997|O1|Outcome|IgPro20 (PK Substudy)|Subjects enrolled and treated with subcutaneous infusion of IgPro20 participating in the pharmacokinetic sub-study
1108435|NCT00542997|O1|Outcome|IgPro20|Subjects enrolled and treated with subcutaneous infusion of IgPro20
1108436|NCT00542997|O1|Outcome|IgPro20|Subjects enrolled and treated with subcutaneous infusion of IgPro20
1108437|NCT00542997|O1|Outcome|IgPro20|Subjects enrolled and treated with subcutaneous infusion of IgPro20
1108438|NCT00542997|O1|Outcome|IgPro20|Subjects enrolled and treated with subcutaneous infusion of IgPro20
1108439|NCT00542997|O1|Outcome|IgPro20|Subjects enrolled and treated with subcutaneous infusion of IgPro20
1108440|NCT00542997|O1|Outcome|IgPro20|Subjects enrolled and treated with subcutaneous infusion of IgPro20
1114309|NCT00529542|O2|Outcome|Placebo|Placebo qd
1108441|NCT00542997|O2|Outcome|Pre-study IgG Treatment|Enrolled subjects with at least 3 documented IgG trough values ≥ 5 g/L during up to 6 months of intravenous (IGIV) or subcutaneous (IGSC) replacement therapy prior to receiving IgPro20 study treatment.
1108442|NCT00542997|O1|Outcome|IgPro20|Subjects enrolled and treated with subcutaneous infusion of IgPro20 during the Efficacy Period (Infusions 12 to 17)
1108443|NCT00542997|E1|Reported Event|IgPro20 (All Treated)|All subjects receiving at least 1 infusion of IgPro20
1108444|NCT00542971|B1|Baseline|Sorafenib + Idarubicin + Ara-C|Sorafenib starting dose 400 mg orally for 7 days; Idarubicin 12 mg/m2 intravenous (IV) daily (days 1-3); and Ara-C 1.5 g/m2 IV over 24 hours daily (days 1-4)
1108445|NCT00542971|P1|Participant Flow|Sorafenib + Idarubicin + Ara-C|Sorafenib starting dose 400 mg orally for 7 days; Idarubicin 12 mg/m2 intravenous (IV) daily (days 1-3); and Ara-C 1.5 g/m2 IV over 24 hours daily (days 1-4)
1108446|NCT00542971|O1|Outcome|Sorafenib + Idarubicin + Ara-C|Sorafenib starting dose 400 mg orally for 7 days; Idarubicin 12 mg/m2 intravenous (IV) daily (days 1-3); and Ara-C 1.5 g/m2 IV over 24 hours daily (days 1-4)
1108447|NCT00542971|O1|Outcome|Sorafenib + Idarubicin + Ara-C|Sorafenib starting dose 400 mg orally for 7 days; Idarubicin 12 mg/m2 intravenous (IV) daily (days 1-3); and Ara-C 1.5 g/m2 IV over 24 hours daily (days 1-4)
1108448|NCT00542971|E1|Reported Event|Sorafenib + Idarubicin + Ara-C|Sorafenib starting dose 400 mg orally for 7 days; Idarubicin 12 mg/m2 intravenous (IV) daily (days 1-3); and Ara-C 1.5 g/m2 IV over 24 hours daily (days 1-4)
1108449|NCT00542880|B3|Baseline|Total|Total of all reporting groups
1108450|NCT00542880|B2|Baseline|Seretide Diskus First, Then Symbicort Turbuhaler|Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
1108451|NCT00542880|B1|Baseline|Symbicort Turbuhaler First, Then Seretide Diskus|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg
1108452|NCT00542880|P2|Participant Flow|Seretide Diskus First, Then Symbicort Turbuhaler|Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
1108453|NCT00542880|P1|Participant Flow|Symbicort Turbuhaler First, Then Seretide Diskus|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg
1108454|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
1108455|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
1108456|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
1108457|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
1108458|NCT00542880|O2|Outcome|Seretide Diskus First|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
1108459|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
1108460|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
1108467|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
1108468|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
1108469|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
1108470|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
1108471|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
1108472|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
1108473|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
1108474|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
1108475|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
1108476|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
1108477|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
1108478|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
1108479|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
1108480|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
1108481|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
1108482|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
1108483|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
1108484|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
1108485|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
1108486|NCT00542880|E2|Reported Event|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
1108487|NCT00542880|E1|Reported Event|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
1108488|NCT00542828|B1|Baseline|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
1108489|NCT00542828|P1|Participant Flow|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
1108490|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
1108491|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
1108492|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
1108493|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
1108494|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
1108495|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
1108496|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
1108497|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
1108498|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
1108499|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
1108500|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
1108505|NCT00542815|B2|Baseline|MCI-196 From E07 Study|3, 6, 9, 12, or 15g / day as titrated
1108506|NCT00542815|B1|Baseline|MCI-196 From E07 / E08 Studies|3, 6, 9, 12, or 15g / day as titrated
1108507|NCT00542815|P3|Participant Flow|Sevelamer From E07 Study|2.4, 4.8, 7.2, 9.6, or 12.0g / day as titrated
1108508|NCT00542815|P2|Participant Flow|MCI-196 From E07 Study|3, 6, 9, 12, or 15g / day as titrated
1108509|NCT00542815|P1|Participant Flow|MCI-196 From E07 / E08 Studies|3, 6, 9, 12, or 15g / day as titrated
1108510|NCT00542815|O3|Outcome|Sevelamer From E07 Study|2.4, 4.8, 7.2, 9.6, or 12.0g / day as titrated
1108511|NCT00542815|O2|Outcome|MCI-196 From E07 Study|3, 6, 9, 12, or 15g / day as titrated
1108512|NCT00542815|O1|Outcome|MCI-196 From E07 / E08 Studies|3, 6, 9, 12, or 15g / day as titrated
1108513|NCT00542815|O3|Outcome|Sevelamer From E07 Study|2.4, 4.8, 7.2, 9.6, or 12.0g / day as titrated
1108514|NCT00542815|O2|Outcome|MCI-196 From E07 Study|3, 6, 9, 12, or 15g / day as titrated
1108515|NCT00542815|O1|Outcome|MCI-196 From E07 / E08 Studies|3, 6, 9, 12, or 15g / day as titrated
1108516|NCT00542815|E3|Reported Event|Sevelamer From E07 Study|2.4, 4.8, 7.2, 9.6, or 12.0g / day as titrated
1108517|NCT00542815|E2|Reported Event|MCI-196 From E07 Study|3, 6, 9, 12, or 15g / day as titrated
1108518|NCT00542815|E1|Reported Event|MCI-196 From E07/E08 Studies|3, 6, 9, 12, or 15g / day as titrated
1108519|NCT00542789|B3|Baseline|Total|Total of all reporting groups
1108520|NCT00542789|B2|Baseline|Comparater: Placebo|Placebo once daily oral
1108521|NCT00542789|B1|Baseline|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily oral
1108522|NCT00542789|P2|Participant Flow|Comparater: Placebo|Placebo once daily oral
1108523|NCT00542789|P1|Participant Flow|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily oral
1108524|NCT00542789|O2|Outcome|Comparater: Placebo|Placebo once daily oral
1108525|NCT00542789|O1|Outcome|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily oral
1108526|NCT00542789|O2|Outcome|Comparater: Placebo|Placebo once daily oral
1108527|NCT00542789|O1|Outcome|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily oral
1108528|NCT00542789|O2|Outcome|Comparater: Placebo|Placebo once daily oral
1108529|NCT00542789|O1|Outcome|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily oral
1108530|NCT00542789|E2|Reported Event|Comparater: Placebo|Placebo once daily oral
1108531|NCT00542789|E1|Reported Event|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily oral
1108533|NCT00542620|B2|Baseline|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108534|NCT00542620|B1|Baseline|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108535|NCT00542620|P2|Participant Flow|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108536|NCT00542620|P1|Participant Flow|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108537|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108538|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108539|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108540|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108541|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108542|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108543|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108544|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108545|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108546|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108547|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108548|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108959|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1108549|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108550|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108551|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108552|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108553|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108554|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108555|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108556|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108557|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108558|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108559|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108632|NCT00542425|O2|Outcome|BA058 20 µg|
1108633|NCT00542425|O1|Outcome|Placebo|
1108634|NCT00542425|O5|Outcome|Teriparatide|
1108560|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108561|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108562|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108563|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108564|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108565|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108566|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108567|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108568|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108569|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108570|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108571|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108572|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108573|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108574|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108575|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108576|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108577|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108578|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108579|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108580|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108581|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108582|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108583|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108584|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108585|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108586|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108635|NCT00542425|O4|Outcome|BA058 80 µg|
1108636|NCT00542425|O3|Outcome|BA058 40 µg|
1108637|NCT00542425|O2|Outcome|BA058 20 µg|
1108587|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108588|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108589|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108590|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108591|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108592|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108593|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108594|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108595|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108596|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108597|NCT00542620|E2|Reported Event|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108598|NCT00542620|E1|Reported Event|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
1108599|NCT00542542|B3|Baseline|Total|Total of all reporting groups
1108600|NCT00542542|B2|Baseline|Group 2: General Anesthesia Alone|"General Anesthesia Alone (Propofol, Midazolam, Fentanyl)~Propofol: 2-2.5 mg/kg IV over 1-4 hours during surgery.~Fentanyl: 50-250 mcg IV over 1-4 hours during surgery.~Midazolam: 0.08 mg/kg IV over 1-4 hours during the surgery."
1108601|NCT00542542|B1|Baseline|Group 1: Paravertebral Block + General Anesthesia|"Paravertebral Block + General Anesthesia (Ropivacaine)~Paravertebral Block: Paravertebral block given as a bolus injection into the paravertebral space.~Ropivacaine: Ropivacaine given by injection into the paravertebral space along the spinal canal."
1108602|NCT00542542|P2|Participant Flow|Group 2: General Anesthesia Alone|"General Anesthesia Alone (Propofol, Midazolam, Fentanyl)~Propofol: 2-2.5 mg/kg IV over 1-4 hours during surgery.~Fentanyl: 50-250 mcg IV over 1-4 hours during surgery.~Midazolam: 0.08 mg/kg IV over 1-4 hours during the surgery."
1108603|NCT00542542|P1|Participant Flow|Group 1: Paravertebral Block + General Anesthesia|"Paravertebral Block + General Anesthesia (Ropivacaine)~Paravertebral Block: Paravertebral block given as a bolus injection into the paravertebral space.~Ropivacaine: Ropivacaine given by injection into the paravertebral space along the spinal canal."
1108604|NCT00542542|O2|Outcome|Group 2: General Anesthesia Alone|"General Anesthesia Alone (Propofol, Midazolam, Fentanyl)~Propofol: 2-2.5 mg/kg IV over 1-4 hours during surgery.~Fentanyl: 50-250 mcg IV over 1-4 hours during surgery.~Midazolam: 0.08 mg/kg IV over 1-4 hours during the surgery."
1108605|NCT00542542|O1|Outcome|Group 1: Paravertebral Block + General Anesthesia|"Paravertebral Block + General Anesthesia (Ropivacaine)~Paravertebral Block: Paravertebral block given as a bolus injection into the paravertebral space.~Ropivacaine: Ropivacaine given by injection into the paravertebral space along the spinal canal."
1108606|NCT00542542|E2|Reported Event|Group 2: General Anesthesia Alone|"General Anesthesia Alone (Propofol, Midazolam, Fentanyl)~Propofol: 2-2.5 mg/kg IV over 1-4 hours during surgery.~Fentanyl: 50-250 mcg IV over 1-4 hours during surgery.~Midazolam: 0.08 mg/kg IV over 1-4 hours during the surgery."
1108607|NCT00542542|E1|Reported Event|Group 1: Paravertebral Block + General Anesthesia|"Paravertebral Block + General Anesthesia (Ropivacaine)~Paravertebral Block: Paravertebral block given as a bolus injection into the paravertebral space.~Ropivacaine: Ropivacaine given by injection into the paravertebral space along the spinal canal."
1108608|NCT00542425|B6|Baseline|Total|Total of all reporting groups
1108609|NCT00542425|B5|Baseline|Teriparatide|
1108610|NCT00542425|B4|Baseline|BA058 80 µg|
1108611|NCT00542425|B3|Baseline|BA058 40 µg|
1108612|NCT00542425|B2|Baseline|BA058 20 µg|
1108613|NCT00542425|B1|Baseline|Placebo|
1108614|NCT00542425|P5|Participant Flow|Teriparatide|
1108615|NCT00542425|P4|Participant Flow|BA058 80 µg|
1108616|NCT00542425|P3|Participant Flow|BA058 40 µg|
1108617|NCT00542425|P2|Participant Flow|BA058 20 µg|
1108618|NCT00542425|P1|Participant Flow|Placebo|
1108619|NCT00542425|O5|Outcome|Teriparatide|
1108620|NCT00542425|O4|Outcome|BA058 80 µg|
1108621|NCT00542425|O3|Outcome|BA058 40 µg|
1108622|NCT00542425|O2|Outcome|BA058 20 µg|
1108623|NCT00542425|O1|Outcome|Placebo|
1108624|NCT00542425|O5|Outcome|Teriparatide|
1108625|NCT00542425|O4|Outcome|BA058 80 µg|
1108626|NCT00542425|O3|Outcome|BA058 40 µg|
1108627|NCT00542425|O2|Outcome|BA058 20 µg|
1108628|NCT00542425|O1|Outcome|Placebo|
1108629|NCT00542425|O5|Outcome|Teriparatide|
1108630|NCT00542425|O4|Outcome|BA058 80 µg|
1108650|NCT00542386|B6|Baseline|Pooled Placebo|Placebo 9 tablets, 12 tablets and 15 tablets/ day
1108651|NCT00542386|B5|Baseline|MCI-196: 15 g|MCI-196: 15 g/ day
1108652|NCT00542386|B4|Baseline|MCI-196: 12 g|MCI-196: 12 g/ day
1108653|NCT00542386|B3|Baseline|MCI-196: 9 g|MCI-196: 9 g/ day
1108654|NCT00542386|B2|Baseline|MCI-196: 6 g|MCI-196: 6 g/ day
1108655|NCT00542386|B1|Baseline|MCI-196: 3 g|MCI-196: 3 g/ day
1108656|NCT00542386|P6|Participant Flow|Pooled Placebo|Placebo 9 tablets, 12 tablets and 15 tablets/ day
1108657|NCT00542386|P5|Participant Flow|MCI-196: 15 g|MCI-196: 15 g/ day
1108658|NCT00542386|P4|Participant Flow|MCI-196: 12 g|MCI-196: 12 g/ day
1108659|NCT00542386|P3|Participant Flow|MCI-196: 9 g|MCI-196: 9 g/ day
1108660|NCT00542386|P2|Participant Flow|MCI-196: 6 g|MCI-196: 6 g/ day
1108661|NCT00542386|P1|Participant Flow|MCI-196: 3 g|MCI-196: 3 g/ day
1108662|NCT00542386|O6|Outcome|Pooled Placebo|Placebo 9 tablets, 12 tablets and 15 tablets/ day
1108663|NCT00542386|O5|Outcome|MCI-196: 15 g|MCI-196: 15 g/ day
1108664|NCT00542386|O4|Outcome|MCI-196: 12 g|MCI-196: 12 g/ day
1108665|NCT00542386|O3|Outcome|MCI-196: 9 g|MCI-196: 9 g/ day
1108666|NCT00542386|O2|Outcome|MCI-196: 6 g|MCI-196: 6 g/ day
1108667|NCT00542386|O1|Outcome|MCI-196: 3 g|MCI-196: 3 g/ day
1108668|NCT00542386|O6|Outcome|Pooled Placebo|Placebo 9 tablets, 12 tablets and 15 tablets/ day
1108669|NCT00542386|O5|Outcome|MCI-196: 15 g|MCI-196: 15 g/ day
1108670|NCT00542386|O4|Outcome|MCI-196: 12 g|MCI-196: 12 g/ day
1108671|NCT00542386|O3|Outcome|MCI-196: 9 g|MCI-196: 9 g/ day
1108672|NCT00542386|O2|Outcome|MCI-196: 6 g|MCI-196: 6 g/ day
1108673|NCT00542386|O1|Outcome|MCI-196: 3 g|MCI-196: 3 g/ day
1108674|NCT00542386|E6|Reported Event|Pooled Placebo|Placebo 9 tablets, 12 tablets and 15 tablets/ day
1108675|NCT00542386|E5|Reported Event|MCI-196: 15 g|MCI-196: 15 g/ day
1108676|NCT00542386|E4|Reported Event|MCI-196: 12 g|MCI-196: 12 g/ day
1108677|NCT00542386|E3|Reported Event|MCI-196: 9 g|MCI-196: 9 g/ day
1108678|NCT00542386|E2|Reported Event|MCI-196: 6 g|MCI-196: 6 g/ day
1108679|NCT00542386|E1|Reported Event|MCI-196: 3 g|MCI-196: 3 g/ day
1108680|NCT00542321|B3|Baseline|Total|Total of all reporting groups
1108681|NCT00542321|B2|Baseline|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
1108682|NCT00542321|B1|Baseline|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
1108683|NCT00542321|P2|Participant Flow|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
1108684|NCT00542321|P1|Participant Flow|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
1108685|NCT00542321|O2|Outcome|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
1108686|NCT00542321|O1|Outcome|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
1108687|NCT00542321|O2|Outcome|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
1108688|NCT00542321|O1|Outcome|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
1108689|NCT00542321|O2|Outcome|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
1108690|NCT00542321|O1|Outcome|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
1108691|NCT00542321|O2|Outcome|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
1108692|NCT00542321|O1|Outcome|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
1108693|NCT00542321|O2|Outcome|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
1108694|NCT00542321|O1|Outcome|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
1108695|NCT00542321|E2|Reported Event|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
1108696|NCT00542321|E1|Reported Event|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
1108697|NCT00542308|B1|Baseline|Zalutumumab 4-16 mg/kg|Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
1108698|NCT00542308|P1|Participant Flow|Zalutumumab 4-16 mg/kg|Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
1108699|NCT00542308|O1|Outcome|Zalutumumab 4-16 mg/kg|Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
1108700|NCT00542308|O1|Outcome|Zalutumumab 4-16 mg/kg|Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
1108701|NCT00542308|E1|Reported Event|Zalutumumab 4-16 mg/kg|Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
1108702|NCT00542269|B4|Baseline|Total|Total of all reporting groups
1109196|NCT00541190|E1|Reported Event|Cystic Fibrosis|Cystic fibrosis patients
1108703|NCT00542269|B3|Baseline|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
1108704|NCT00542269|B2|Baseline|Aliskiren /Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
1108705|NCT00542269|B1|Baseline|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
1108706|NCT00542269|P3|Participant Flow|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
1108707|NCT00542269|P2|Participant Flow|Aliskiren /Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
1108708|NCT00542269|P1|Participant Flow|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
1108766|NCT00541970|B2|Baseline|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1109940|NCT00539591|O1|Outcome|Pretherapy|QoL assessment completed before start of therapy.
1108709|NCT00542269|O3|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
1108710|NCT00542269|O2|Outcome|Aliskiren /Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
1108711|NCT00542269|O1|Outcome|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
1108712|NCT00542269|O2|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
1108713|NCT00542269|O1|Outcome|Aliskiren / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
1108741|NCT00542178|B2|Baseline|Standard Glycemia Control|A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
1108742|NCT00542178|B1|Baseline|Intensive Glycemia Control|A strategy of intensive glycemia treatment to HbA1c less than 6%
1108743|NCT00542178|P8|Participant Flow|Standard Glycemia Control & Fibrate Placebo|"Standard Glycemia Control: A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%~Fibrate Placebo: Blinded placebo + simvastatin 20-40 mg/d"
1108714|NCT00542269|O2|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
1108715|NCT00542269|O1|Outcome|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
1108716|NCT00542269|O3|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
1108717|NCT00542269|O2|Outcome|Aliskiren /Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
1108718|NCT00542269|O1|Outcome|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
1108719|NCT00542269|O3|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
1108919|NCT00541775|B4|Baseline|Total|Total of all reporting groups
1108720|NCT00542269|O2|Outcome|Aliskiren /Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
1108721|NCT00542269|O1|Outcome|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
1108722|NCT00542269|O3|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
1108723|NCT00542269|O2|Outcome|Aliskiren /Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
1108724|NCT00542269|O1|Outcome|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
1108744|NCT00542178|P7|Participant Flow|Intensive Glycemia Control & Fibrate Placebo|"Intensive Glycemia Control: A strategy of intensive glycemia treatment to HbA1c less than 6%~Fibrate Placebo: Blinded placebo + simvastatin 20-40 mg/d"
1108745|NCT00542178|P6|Participant Flow|Standard Glycemia Control & Fibrate|"Standard Glycemia Control: A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%~Fibrate: Blinded fenofibrate + simvastatin 20-40 mg/d"
1109453|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
1108725|NCT00542269|O2|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
1108726|NCT00542269|O1|Outcome|Aliskiren / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
1108727|NCT00542269|O2|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
1108728|NCT00542269|O1|Outcome|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
1108729|NCT00542269|O2|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
1108730|NCT00542269|O1|Outcome|Aliskiren / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
1108731|NCT00542269|O2|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
1108732|NCT00542269|O1|Outcome|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
1108733|NCT00542269|E3|Reported Event|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
1108734|NCT00542269|E2|Reported Event|Aliskiren /Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
1108735|NCT00542269|E1|Reported Event|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
1108736|NCT00542178|B7|Baseline|Total|Total of all reporting groups
1108737|NCT00542178|B6|Baseline|Fibrate Placebo|Blinded placebo + simvastatin 20-40 mg/d
1108738|NCT00542178|B5|Baseline|Fibrate|Blinded fenofibrate + simvastatin 20-40 mg/d
1108739|NCT00542178|B4|Baseline|Standard BP Control|A strategy of BP treatment for SBP less than 140 mm Hg
1108740|NCT00542178|B3|Baseline|Intensive BP Control|A strategy of BP treatment for SBP less than 120 mm Hg
1108746|NCT00542178|P5|Participant Flow|Intensive Glycemia Control & Fibrate|"Intensive Glycemia Control: A strategy of intensive glycemia treatment to HbA1c less than 6%~Fibrate: Blinded fenofibrate + simvastatin 20-40 mg/d"
1108747|NCT00542178|P4|Participant Flow|Standard Glycemia Control & Standard Blood Pressure Control|"Standard Glycemia Control: A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%~Standard Blood Pressure Control: A strategy of BP treatment for SBP less than 140 mm Hg"
1108748|NCT00542178|P3|Participant Flow|Intensive Glycemia Control & Standard Blood Pressure Control|"Intensive Glycemia Control: A strategy of intensive glycemia treatment to HbA1c less than 6%~Standard Blood Pressure Control: A strategy of BP treatment for SBP less than 140 mm Hg"
1108749|NCT00542178|P2|Participant Flow|Standard Glycemia Control & Intensive Blood Pressure Control|"Standard Glycemia Control: A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%~Intensive Blood Pressure Control: A strategy of BP treatment for SBP less than 120 mm Hg"
1108750|NCT00542178|P1|Participant Flow|Intensive Glycemia Control & Intensive Blood Pressure Control|"Intensive Glycemia Control: A strategy of intensive glycemia treatment to HbA1c less than 6%~Intensive Blood Pressure Control: A strategy of BP treatment for SBP less than 120 mm Hg"
1108751|NCT00542178|O6|Outcome|Placebo + Simvastatin Therapy|Blinded placebo + simvastatin 20-40 mg/d
1108752|NCT00542178|O5|Outcome|Fenofibrate + Simvastatin Therapy|Blinded fenofibrate + simvastatin 20-40 mg/d
1108753|NCT00542178|O4|Outcome|Standard Blood Pressure Control|Strategy of BP treatment for SBP less than 140 mmHg
1108754|NCT00542178|O3|Outcome|Intensive Blood Pressure Control|A strategy of BP treatment for SBP less than 120 mmHg
1108755|NCT00542178|O2|Outcome|Standard Glycemia Control|Strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
1108756|NCT00542178|O1|Outcome|Intensive Glycemia Control|Strategy of intensive glycemia treatment to HbA1c less than 6%
1108757|NCT00542178|E6|Reported Event|Fibrate Placebo|Blinded placebo + simvastatin 20-40 mg/d
1108758|NCT00542178|E5|Reported Event|Fibrate|Blinded fenofibrate + simvastatin 20-40 mg/d
1108759|NCT00542178|E4|Reported Event|Standard BP Control|A strategy of BP treatment for SBP less than 140 mm Hg
1108760|NCT00542178|E3|Reported Event|Intensive BP Control|A strategy of BP treatment for SBP less than 120 mm Hg
1108761|NCT00542178|E2|Reported Event|Standard Glycemia Control|A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
1108762|NCT00542178|E1|Reported Event|Intensive Glycemia Control|A strategy of intensive glycemia treatment to HbA1c less than 6%
1108763|NCT00541970|B5|Baseline|Total|Total of all reporting groups
1108764|NCT00541970|B4|Baseline|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108765|NCT00541970|B3|Baseline|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108958|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1110101|NCT00539188|B3|Baseline|Total|Total of all reporting groups
1108767|NCT00541970|B1|Baseline|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108768|NCT00541970|P4|Participant Flow|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108769|NCT00541970|P3|Participant Flow|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108770|NCT00541970|P2|Participant Flow|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108771|NCT00541970|P1|Participant Flow|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108772|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108773|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108774|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108775|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108776|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108777|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108778|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1109526|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
1108779|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108780|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108781|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108782|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108783|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108784|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108785|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108786|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108787|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108788|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108789|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108790|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108791|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1110589|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
1108792|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108793|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108794|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108795|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108796|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108797|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108798|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108799|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108800|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108801|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108802|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108803|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108804|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108805|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108806|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108807|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108808|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108809|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108810|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108811|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108812|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108813|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108814|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108815|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108816|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108817|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108818|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108819|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108820|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108821|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108822|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108823|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108824|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108825|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108826|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108827|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108828|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108829|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108934|NCT00541775|O1|Outcome|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
1108830|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108831|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108832|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108833|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108834|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108835|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108836|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108837|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108838|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108839|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108840|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108841|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108842|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108843|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108844|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108845|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108846|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108847|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108848|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108849|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108850|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108851|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108852|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108853|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108854|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108935|NCT00541775|E3|Reported Event|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
1108855|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108856|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108857|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108858|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108859|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108860|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108861|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108862|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108863|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108864|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108865|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108866|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108867|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108868|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108869|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108870|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108871|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108872|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108873|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108874|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108875|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108876|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108877|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108878|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108879|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108880|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108881|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108882|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108883|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108884|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108885|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108886|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108887|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108888|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108889|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108890|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108891|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108892|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108893|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108894|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108895|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108896|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108897|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108898|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108899|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108900|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108901|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108902|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108903|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108904|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108905|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108980|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1108906|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108907|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108908|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108909|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108910|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108911|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108912|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108913|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108914|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108915|NCT00541970|E4|Reported Event|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
1108916|NCT00541970|E3|Reported Event|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108917|NCT00541970|E2|Reported Event|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108918|NCT00541970|E1|Reported Event|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
1108920|NCT00541775|B3|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
1108921|NCT00541775|B2|Baseline|Rosiglitazone|The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
1108922|NCT00541775|B1|Baseline|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
1108923|NCT00541775|P3|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
1108924|NCT00541775|P2|Participant Flow|Rosiglitazone|The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
1108925|NCT00541775|P1|Participant Flow|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
1108926|NCT00541775|O3|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
1108927|NCT00541775|O2|Outcome|Rosiglitazone|The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
1108928|NCT00541775|O1|Outcome|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
1108929|NCT00541775|O3|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
1108930|NCT00541775|O2|Outcome|Rosiglitazone|The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
1108931|NCT00541775|O1|Outcome|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
1108932|NCT00541775|O3|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
1108933|NCT00541775|O2|Outcome|Rosiglitazone|The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
1108936|NCT00541775|E2|Reported Event|Rosiglitazone|The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
1108937|NCT00541775|E1|Reported Event|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
1108938|NCT00541671|B3|Baseline|Total|Total of all reporting groups
1108939|NCT00541671|B2|Baseline|Promethazine|Patients will be randomized to 6.25mg of promethazine, consisting of 0.25ml of promethazine diluted in 9.75ml of normal saline.
1108940|NCT00541671|B1|Baseline|Placebo|Patients will then be randomized to receive placebo, consisting of 10ml of normal saline solution to be administered intravenously with the narcotic
1108941|NCT00541671|P2|Participant Flow|Promethazine|Patients will be randomized to 6.25mg of promethazine, consisting of 0.25ml of promethazine diluted in 9.75ml of normal saline.
1108942|NCT00541671|P1|Participant Flow|Placebo|Patients will then be randomized to receive placebo, consisting of 10ml of normal saline solution to be administered intravenously with the narcotic
1108943|NCT00541671|O2|Outcome|Promethazine|Patients will be randomized to 6.25mg of promethazine, consisting of 0.25ml of promethazine diluted in 9.75ml of normal saline.
1108944|NCT00541671|O1|Outcome|Placebo|Patients will then be randomized to receive placebo, consisting of 10ml of normal saline solution to be administered intravenously with the narcotic
1108945|NCT00541671|E2|Reported Event|Promethazine|
1108946|NCT00541671|E1|Reported Event|Placebo|
1108947|NCT00541658|B4|Baseline|Total|Total of all reporting groups
1108948|NCT00541658|B3|Baseline|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1108949|NCT00541658|B2|Baseline|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1108950|NCT00541658|B1|Baseline|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1108951|NCT00541658|P3|Participant Flow|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1108952|NCT00541658|P2|Participant Flow|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1108953|NCT00541658|P1|Participant Flow|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1108954|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1108955|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1108956|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1108957|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1114310|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
1108960|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1108961|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1108962|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1108963|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1108964|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1108965|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1108966|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1108967|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1108968|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1108969|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1108970|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1108971|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1108972|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1108973|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1108974|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1108975|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1108976|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1108977|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1108978|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1108979|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1108981|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1108982|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1108983|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1108984|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1108985|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1108986|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1108987|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1108988|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1108989|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1108990|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1108991|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1108992|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1108993|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1108994|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1108995|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1108996|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1108997|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1108998|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1108999|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109000|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109001|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109002|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109003|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109004|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109005|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109006|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109007|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109008|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109009|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109010|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109011|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109012|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109013|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109014|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109015|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109016|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109017|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109018|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109019|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109020|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109021|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109022|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109023|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109024|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109025|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109026|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109027|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109028|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109029|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109030|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109031|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109032|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109033|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109034|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109035|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109036|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109037|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109038|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109039|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109040|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109041|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109042|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109043|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109044|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109045|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109046|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109047|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109048|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109049|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109050|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109051|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109052|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109053|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109054|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109055|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109056|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109057|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109058|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109059|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109060|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109061|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109062|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109063|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109064|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109065|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109066|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109067|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109068|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109069|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109070|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109071|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109072|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109073|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109074|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109075|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109076|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109077|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109078|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109079|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109080|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109081|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109082|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109083|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109084|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109085|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109086|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109087|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109088|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109089|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109090|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109091|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109092|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109093|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109094|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109095|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109096|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109097|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109098|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109099|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109100|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109101|NCT00541658|O2|Outcome|35 mg DRFB + DRBB|Combined two arms - 35 mg delayed-release following breakfast (DRFB) with 35 mg delayed-relase before breakfast (DRBB)
1109102|NCT00541658|O1|Outcome|5 mg IRBB|5 mg immediate-release risedronate tablet daily, at least 30 minutes before breakfast for two years
1109103|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109104|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109105|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109106|NCT00541658|E3|Reported Event|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
1109107|NCT00541658|E2|Reported Event|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
1109108|NCT00541658|E1|Reported Event|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
1109109|NCT00541593|B1|Baseline|NOTES Pancreatic Pseudocystgastrostomy Patients|Patients who undergo pancreatic pseudocystgastrostomy via a NOTES technique. All of them are candidates for open or laparoscopic pancreatic pseudocystgastrostomy, but have chosen a less invasive result. Also, all of them have to have imaging criteria which suggest that the stomach and pseudocyst are in close contact, and that the cyst is proximal enough in the stomach to be reachable with an endoscope and/or endoscopic stapler.
1109166|NCT00541242|E1|Reported Event|Bimatoprost 0.03% Eye Drops|Bimatoprost 0.03% eye drops
1109110|NCT00541593|P1|Participant Flow|NOTES Pancreatic Pseudocystgastrostomy Patients|Patients who undergo pancreatic pseudocystgastrostomy via a NOTES technique. All of them are candidates for open or laparoscopic pancreatic pseudocystgastrostomy, but have chosen a less invasive result. Also, all of them have to have imaging criteria which suggest that the stomach and pseudocyst are in close contact, and that the cyst is proximal enough in the stomach to be reachable with an endoscope and/or endoscopic stapler.
1109111|NCT00541593|O1|Outcome|NOTES Pancreatic Pseudocystgastrostomy Patients|Pancreatic Pseudocystgastrostomy Patients having NOTES procedure
1109112|NCT00541593|E1|Reported Event|NOTES Pancreatic Pseudocystgastrostomy Patients|Patients who undergo pancreatic pseudocystgastrostomy via a NOTES technique. All of them are candidates for open or laparoscopic pancreatic pseudocystgastrostomy, but have chosen a less invasive result. Also, all of them have to have imaging criteria which suggest that the stomach and pseudocyst are in close contact, and that the cyst is proximal enough in the stomach to be reachable with an endoscope and/or endoscopic stapler.
1109113|NCT00541450|B3|Baseline|Total|Total of all reporting groups
1109114|NCT00541450|B2|Baseline|Pioglitazone|"In Phase A (Treatment Day 1 up to Week 12), participants in the pioglitazone group were administered 15 mg once daily (q.d.) of pioglitazone and matching placebo to sitagliptin. At Week 6, all participants were administered 30 mg q.d. pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were administered 45 mg pioglitazone once daily (q.d.)."
1109115|NCT00541450|B1|Baseline|Sita/Met FDC|"In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks."
1109116|NCT00541450|P2|Participant Flow|Pioglitazone|"In Phase A (Treatment Day 1 up to Week 12), participants in the pioglitazone group were administered 15 mg once daily (q.d.) of pioglitazone and matching placebo to sitagliptin. At Week 6, all participants were administered 30 mg q.d. pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were administered 45 mg pioglitazone once daily (q.d.)."
1109117|NCT00541450|P1|Participant Flow|Sita/Met FDC|"In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks."
1109118|NCT00541450|O2|Outcome|Pioglitazone (Phase A)|In Phase A (Treatment Day 1 up to Week 12), participants in the Pioglitazone group were administered 15 mg q.d. of pioglitazone or matching placebo. At Week 6, participants were administered 30 mg q.d. pioglitazone.
1109119|NCT00541450|O1|Outcome|Sitagliptin (Phase A)|In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg q.d. of sitagliptin or matching placebo.
1109120|NCT00541450|O2|Outcome|Pioglitazone|"In Phase A (Treatment Day 1 up to Week 12), participants in the pioglitazone group were administered 15 mg once daily (q.d.) of pioglitazone and matching placebo to sitagliptin. At Week 6, all participants were administered 30 mg q.d. pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were administered 45 mg pioglitazone once daily (q.d.)."
1109144|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
1109121|NCT00541450|O1|Outcome|Sita/Met FDC|"In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks."
1109122|NCT00541450|O2|Outcome|Pioglitazone (Phase A)|In Phase A (Treatment Day 1 up to Week 12), participants in the Pioglitazone group were administered 15 mg q.d. of pioglitazone or matching placebo. At Week 6, participants were administered 30 mg q.d. pioglitazone.
1109123|NCT00541450|O1|Outcome|Sitagliptin (Phase A)|In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg q.d. of sitagliptin or matching placebo.
1109124|NCT00541450|O2|Outcome|Pioglitazone (Phase A)|In Phase A (Treatment Day 1 up to Week 12), participants in the Pioglitazone group were administered 15 mg q.d. of pioglitazone or matching placebo. At Week 6, participants were administered 30 mg q.d. pioglitazone.
1109125|NCT00541450|O1|Outcome|Sitagliptin (Phase A)|In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg q.d. of sitagliptin or matching placebo.
1109126|NCT00541450|O2|Outcome|Pioglitazone|"In Phase A (Treatment Day 1 up to Week 12), participants in the pioglitazone group were administered 15 mg once daily (q.d.) of pioglitazone and matching placebo to sitagliptin. At Week 6, all participants were administered 30 mg q.d. pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were administered 45 mg pioglitazone once daily (q.d.)."
1109127|NCT00541450|O1|Outcome|Sita/Met FDC|"In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks."
1109128|NCT00541450|O2|Outcome|Pioglitazone|"In Phase A (Treatment Day 1 up to Week 12), participants in the pioglitazone group were administered 15 mg once daily (q.d.) of pioglitazone and matching placebo to sitagliptin. At Week 6, all participants were administered 30 mg q.d. pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were administered 45 mg pioglitazone once daily (q.d.)."
1109129|NCT00541450|O1|Outcome|Sita/Met FDC|"In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks."
1109130|NCT00541450|E4|Reported Event|Pioglitazone (Weeks 0-40)|"In Phase A (Treatment Day 1 up to Week 12), randomized participants in the pioglitazone group were administered 15 mg q.d. of pioglitazone or matching placebo to sitagliptin. At Week 6, participants were up-titrated to 30 mg q.d.~In Phase B (Treatment Week 12 -Week 40), participants were administered 45 mg q.d."
1109167|NCT00541229|B7|Baseline|Total|Total of all reporting groups
1109527|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
1109131|NCT00541450|E3|Reported Event|Sita/Met FDC (Weeks 0-40)|"In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg q.d. of sitagliptin or matching placebo to pioglitazone.~In Phase B (Treatment Week 12-Week 40), participants were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg b.i.d., which was increased to 50/1000 mg b.i.d. over a period of 4 weeks."
1109132|NCT00541450|E2|Reported Event|Pioglitazone (Weeks 0-12)|In Phase A (Treatment Day 1 up to Week 12), randomized participants in the pioglitazone group were administered 15 mg q.d. of pioglitazone or matching placebo to sitagliptin. At Week 6, all participants were up-titrated to 30 mg q.d. pioglitazone.
1109133|NCT00541450|E1|Reported Event|Sitagliptin (Weeks 0-12)|In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg q.d. of sitagliptin or matching placebo to pioglitazone.
1109134|NCT00541346|B1|Baseline|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
1109135|NCT00541346|P1|Participant Flow|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
1109136|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
1109137|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
1109138|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
1109139|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
1109140|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
1109141|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
1109142|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
1109143|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
1109145|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
1109146|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
1109147|NCT00541346|E1|Reported Event|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
1109148|NCT00541307|B1|Baseline|Enrolled Subjects|The total number of enrolled subjects.
1109149|NCT00541307|P1|Participant Flow|Gore Viabahn Endoprosthesis|All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.
1109150|NCT00541307|O1|Outcome|Gore Viabahn Endoprosthesis|All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.
1109151|NCT00541307|O1|Outcome|Gore Viabahn Endoprosthesis|All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.
1109152|NCT00541307|O1|Outcome|Gore Viabahn Endoprosthesis|All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.
1109153|NCT00541307|O1|Outcome|Gore Viabahn Endoprosthesis|All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.
1109154|NCT00541307|O1|Outcome|Gore Viabahn Endoprosthesis|All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.
1109155|NCT00541307|E1|Reported Event|Gore VIABAHN Endoprosthesis With Heparin Bioactive Surface|Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface
1109156|NCT00541242|B3|Baseline|Total|Total of all reporting groups
1109157|NCT00541242|B2|Baseline|Latanoprost 0.005% Eye Drops|Latanoprost 0.005% eye drops
1109158|NCT00541242|B1|Baseline|Bimatoprost 0.03% Eye Drops|Bimatoprost 0.03% eye drops
1109159|NCT00541242|P2|Participant Flow|Latanoprost 0.005% Eye Drops|Latanoprost 0.005% eye drops
1109160|NCT00541242|P1|Participant Flow|Bimatoprost 0.03% Eye Drops|Bimatoprost 0.03% eye drops
1109161|NCT00541242|O2|Outcome|Latanoprost 0.005% Eye Drops|Latanoprost 0.005% eye drops
1109162|NCT00541242|O1|Outcome|Bimatoprost 0.03% Eye Drops|Bimatoprost 0.03% eye drops
1109163|NCT00541242|O2|Outcome|Latanoprost 0.005% Eye Drops|Latanoprost 0.005% eye drops
1109164|NCT00541242|O1|Outcome|Bimatoprost 0.03% Eye Drops|Bimatoprost 0.03% eye drops
1109165|NCT00541242|E2|Reported Event|Latanoprost 0.005% Eye Drops|Latanoprost 0.005% eye drops
1109195|NCT00541190|E2|Reported Event|Healthy Controls|Healthy subjects.
1109168|NCT00541229|B6|Baseline|200 mg / 100 mg / Placebo|200 mg / 100 mg / Placebo includes patients receiving once daily administration of the following treatments: sitagliptin 200 mg in Treatment Period I, sitagliptin 100 mg in Treatment Period II (after Washout Period I), and sitagliptin-matching placebo in Treatment Period III (after Washout Period II)
1109169|NCT00541229|B5|Baseline|100 mg / Placebo / 200 mg|100 mg / Placebo / 200 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin 100 mg in Treatment Period I, sitagliptin-matching placebo in Treatment Period II (after Washout Period I), and sitagliptin 200 mg in Treatment Period III (after Washout Period II)
1109170|NCT00541229|B4|Baseline|Placebo / 200 mg / 100 mg|Placebo / 200 mg / 100 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin-matching placebo in Treatment Period I, sitagliptin 200 mg in Treatment Period II (after Washout Period I), and sitagliptin 100 mg in Treatment Period III (after Washout Period II)
1109171|NCT00541229|B3|Baseline|200 mg / Placebo / 100 mg|200 mg / Placebo / 100 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin 200 mg in Treatment Period I, sitagliptin-matching placebo in Treatment Period II (after Washout Period I), and sitagliptin 100 mg in Treatment Period III (after Washout Period II)
1109172|NCT00541229|B2|Baseline|100 mg / 200 mg / Placebo|100 mg / 200 mg / Placebo Group includes patients receiving once daily administration of the following treatments: sitagliptin 100 mg in Treatment Period I, sitagliptin 200 mg in Treatment Period II (after Washout Period I), and sitagliptin-matching placebo in Treatment Period III (after Washout Period II)
1109173|NCT00541229|B1|Baseline|Placebo / 100 mg / 200 mg|Placebo / 100 mg / 200 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin-matching placebo in Treatment Period I, sitagliptin 100 mg in Treatment Period II (after Washout Period I), and sitagliptin 200 mg in Treatment Period III (after Washout Period II)
1109174|NCT00541229|P6|Participant Flow|200 mg / 100 mg / Placebo|200 mg / 100 mg / Placebo includes patients receiving once daily administration of the following treatments: sitagliptin 200 mg in Treatment Period I, sitagliptin 100 mg in Treatment Period II (after Washout Period I), and sitagliptin-matching placebo in Treatment Period III (after Washout Period II)
1109175|NCT00541229|P5|Participant Flow|100 mg / Placebo / 200 mg|100 mg / Placebo / 200 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin 100 mg in Treatment Period I, sitagliptin-matching placebo in Treatment Period II (after Washout Period I), and sitagliptin 200 mg in Treatment Period III (after Washout Period II)
1109176|NCT00541229|P4|Participant Flow|Placebo / 200 mg / 100 mg|Placebo / 200 mg / 100 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin-matching placebo in Treatment Period I, sitagliptin 200 mg in Treatment Period II (after Washout Period I), and sitagliptin 100 mg in Treatment Period III (after Washout Period II)
1109177|NCT00541229|P3|Participant Flow|200 mg / Placebo / 100 mg|200 mg / Placebo / 100 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin 200 mg in Treatment Period I, sitagliptin-matching placebo in Treatment Period II (after Washout Period I), and sitagliptin 100 mg in Treatment Period III (after Washout Period II)
1109178|NCT00541229|P2|Participant Flow|100 mg / 200 mg / Placebo|100 mg / 200 mg / Placebo Group includes patients receiving once daily administration of the following treatments: sitagliptin 100 mg in Treatment Period I, sitagliptin 200 mg in Treatment Period II (after Washout Period I), and sitagliptin-matching placebo in Treatment Period III (after Washout Period II)
1114311|NCT00529542|O2|Outcome|Placebo|Placebo qd
1109179|NCT00541229|P1|Participant Flow|Placebo / 100 mg / 200 mg|Placebo / 100 mg / 200 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin-matching placebo in Treatment Period I, sitagliptin 100 mg in Treatment Period II (after Washout Period I), and sitagliptin 200 mg in Treatment Period III (after Washout Period II)
1109180|NCT00541229|O3|Outcome|Placebo|Placebo group included the Treatment Period I data from patients randomized to treatment sequence placebo/Sitagliptin 100 mg/Sitagliptin 200 mg and treatment sequence placebo/Sitagliptin 200 mg/Sitagliptin 100 mg.
1109181|NCT00541229|O2|Outcome|Sitagliptin 100mg|Sitagliptin 100 mg group included the Treatment Period I data from patients randomized to treatment sequence Sitagliptin 100 mg/Sitagliptin 200 mg/placebo and treatment sequence Sitagliptin 100 mg/ placebo/ Sitagliptin 200 mg.
1109182|NCT00541229|O1|Outcome|Sitagliptin 200mg|Sitagliptin 200 mg group included the Treatment Period I data from patients randomized to treatment sequence Sitagliptin 200 mg/Sitagliptin 100 mg/placebo and treatment sequence Sitagliptin 200 mg/ placebo/ Sitagliptin 100 mg.
1109183|NCT00541229|E3|Reported Event|Placebo|Placebo Group included data from all randomized patients in treatment periods with once-daily administration of sitagliptin-matching placebo tablets. Due to the crossover design, patients are counted in the denominator for each treatment that they received. Patients are counted in the numerator for the treatment that they were receiving at the time when the AE occurred.
1109184|NCT00541229|E2|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg Group included data from all randomized patients in treatment periods with once-daily administration of sitagliptin 100 mg. Due to the crossover design, patients are counted in the denominator for each treatment that they received. Patients are counted in the numerator for the treatment that they were receiving at the time when the AE occurred.
1109185|NCT00541229|E1|Reported Event|Sitagliptin 200 mg|Sitagliptin 200 mg Group included data from all randomized patients in treatment periods with once-daily administration of sitagliptin 200 mg. Due to the crossover design, patients are counted in the denominator for each treatment that they received. Patients are counted in the numerator for the treatment that they were receiving at the time when the AE occurred.
1109186|NCT00541190|B3|Baseline|Total|Total of all reporting groups
1109187|NCT00541190|B2|Baseline|Healthy Controls|Healthy subjects.
1109188|NCT00541190|B1|Baseline|Cystic Fibrosis|Cystic fibrosis patients
1109189|NCT00541190|P2|Participant Flow|Healthy Controls|Healthy subjects.
1109190|NCT00541190|P1|Participant Flow|Cystic Fibrosis|Cystic fibrosis patients
1109191|NCT00541190|O2|Outcome|Healthy Controls|Healthy subjects.
1109192|NCT00541190|O1|Outcome|Cystic Fibrosis|Cystic fibrosis patients
1109193|NCT00541190|O2|Outcome|Healthy Controls|Healthy subjects without lung disease - subjects inhaled a nebulized mixture of Indium 111 DTPA and Technetium 99m sulfur colloid.
1109194|NCT00541190|O1|Outcome|Cystic Fibrosis|Cystic fibrosis patients - subjects inhaled a nebulized mixture of Indium 111 DTPA and Technetium 99m sulfur colloid.
1109197|NCT00541099|B1|Baseline|Avastin & Docetaxel|"Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15~bevacizumab: Avastin 10.0 mg/kg on days 1 and 15~docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15"
1109198|NCT00541099|P1|Participant Flow|Avastin & Docetaxel|"Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15~bevacizumab: Avastin 10.0 mg/kg on days 1 and 15~docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15"
1109199|NCT00541099|O1|Outcome|Avastin & Docetaxel|"Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15~bevacizumab: Avastin 10.0 mg/kg on days 1 and 15~docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15"
1109200|NCT00541099|E1|Reported Event|Avastin & Docetaxel|"Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15~bevacizumab: Avastin 10.0 mg/kg on days 1 and 15~docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15"
1109201|NCT00541034|B1|Baseline|All Patients|All patients who received cyclophosphamide, pentostatin and rituximab
1109202|NCT00541034|P1|Participant Flow|All Patients|All patients who received cyclophosphamide, pentostatin and rituximab
1109203|NCT00541034|O1|Outcome|All Patients|All patients who received cyclophosphamide, pentostatin and rituximab
1109204|NCT00541034|E1|Reported Event|All Patients|All patients who received cyclophosphamide, pentostatin and rituximab
1109205|NCT00540969|B3|Baseline|Total|Total of all reporting groups
1109206|NCT00540969|B2|Baseline|Arm II (External-beam Radiotherapy)|"Patients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week.~radiation therapy: Patients undergo radiotherapy for 1 week"
1109207|NCT00540969|B1|Baseline|Arm I (Percutaneous Cryoablation)|"Cryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively.~cryosurgery: Patients undergo cryosurgery using guidance from CT scan or ultrasound"
1109208|NCT00540969|P2|Participant Flow|Arm II (External-beam Radiotherapy)|"Patients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week.~radiation therapy: Patients undergo radiotherapy for 1 week"
1109209|NCT00540969|P1|Participant Flow|Arm I (Percutaneous Cryoablation)|"Cryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively.~cryosurgery: Patients undergo cryosurgery using guidance from CT scan or ultrasound"
1109210|NCT00540969|O2|Outcome|Arm II (External-beam Radiotherapy)|"Patients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week.~radiation therapy: Patients undergo radiotherapy for 1 week"
1109238|NCT00540592|B4|Baseline|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
1114312|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
1109211|NCT00540969|O1|Outcome|Arm I (Percutaneous Cryoablation)|"Cryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively.~cryosurgery: Patients undergo cryosurgery using guidance from CT scan or ultrasound"
1109212|NCT00540969|O2|Outcome|Arm II (External-beam Radiotherapy)|"Patients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week.~radiation therapy: Patients undergo radiotherapy for 1 week"
1109213|NCT00540969|O1|Outcome|Arm I (Percutaneous Cryoablation)|"Cryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively.~cryosurgery: Patients undergo cryosurgery using guidance from CT scan or ultrasound"
1109214|NCT00540969|O2|Outcome|Arm II (External-beam Radiotherapy)|"Patients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week.~radiation therapy: Patients undergo radiotherapy for 1 week"
1109215|NCT00540969|O1|Outcome|Arm I (Percutaneous Cryoablation)|"Cryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively.~cryosurgery: Patients undergo cryosurgery using guidance from CT scan or ultrasound"
1109216|NCT00540969|E2|Reported Event|Arm II (External-beam Radiotherapy)|"Patients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week.~radiation therapy: Patients undergo radiotherapy for 1 week"
1109217|NCT00540969|E1|Reported Event|Arm I (Percutaneous Cryoablation)|"Cryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively.~cryosurgery: Patients undergo cryosurgery using guidance from CT scan or ultrasound"
1109218|NCT00540644|B3|Baseline|Total|Total of all reporting groups
1109219|NCT00540644|B2|Baseline|Extension - Revlimid, Cyclophosphamide, Prednisone|Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
1109220|NCT00540644|B1|Baseline|Original Study - Revlimid, Cyclophosphamide, Prednisone|Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
1109221|NCT00540644|P2|Participant Flow|Extension - Revlimid, Cyclophosphamide, Prednisone|Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
1109222|NCT00540644|P1|Participant Flow|Original Study - Revlimid, Cyclophosphamide, Prednisone|Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
1109756|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
1109223|NCT00540644|O2|Outcome|Extension - Revlimid, Cyclophosphamide, Prednisone|Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
1109224|NCT00540644|O1|Outcome|Original Study - Revlimid, Cyclophosphamide, Prednisone|Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
1109225|NCT00540644|O2|Outcome|Extension - Revlimid, Cyclophosphamide, Prednisone|Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
1109226|NCT00540644|O1|Outcome|Original Study - Revlimid, Cyclophosphamide, Prednisone|Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
1109227|NCT00540644|O2|Outcome|Extension - Revlimid, Cyclophosphamide, Prednisone|Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
1109228|NCT00540644|O1|Outcome|Original Study - Revlimid, Cyclophosphamide, Prednisone|Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
1109229|NCT00540644|E2|Reported Event|Extension - Revlimid, Cyclophosphamide, Prednisone|Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
1109230|NCT00540644|E1|Reported Event|Original Study - Revlimid, Cyclophosphamide, Prednisone|Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
1109231|NCT00540592|B11|Baseline|Total|Total of all reporting groups
1109232|NCT00540592|B10|Baseline|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
1109233|NCT00540592|B9|Baseline|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
1109234|NCT00540592|B8|Baseline|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
1109235|NCT00540592|B7|Baseline|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
1109236|NCT00540592|B6|Baseline|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
1109237|NCT00540592|B5|Baseline|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
1109239|NCT00540592|B3|Baseline|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
1109240|NCT00540592|B2|Baseline|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
1109241|NCT00540592|B1|Baseline|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
1109242|NCT00540592|P10|Participant Flow|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
1109243|NCT00540592|P9|Participant Flow|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
1109244|NCT00540592|P8|Participant Flow|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
1109245|NCT00540592|P7|Participant Flow|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
1109246|NCT00540592|P6|Participant Flow|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
1109247|NCT00540592|P5|Participant Flow|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
1109248|NCT00540592|P4|Participant Flow|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
1109249|NCT00540592|P3|Participant Flow|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
1109250|NCT00540592|P2|Participant Flow|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
1109251|NCT00540592|P1|Participant Flow|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
1109252|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
1109253|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
1109254|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
1109255|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
1109256|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
1109257|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
1109258|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
1109259|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
1109260|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
1109261|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
1109262|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
1109263|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
1109264|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
1109265|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
1109266|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
1109267|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
1109268|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
1109269|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
1109270|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
1109271|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
1109272|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
1109273|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
1109274|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
1109275|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
1109276|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
1109277|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
1114313|NCT00529542|O2|Outcome|Placebo|Placebo qd
1109278|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
1109279|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
1109280|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
1109281|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
1109282|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
1109283|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
1109284|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
1109285|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
1109286|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
1109287|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
1109288|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
1109289|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
1109290|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
1109291|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
1109292|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
1109293|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
1109294|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
1109295|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
1109296|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
1109528|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
1109297|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
1109298|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
1109299|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
1109300|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
1109301|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
1109302|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
1109303|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
1109304|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
1109305|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
1109306|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
1109307|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
1109308|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
1109309|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
1109310|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
1109311|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
1109312|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
1109313|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
1109314|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
1109315|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
1109316|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
1109317|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
1109318|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
1109319|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
1109320|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
1109321|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
1109322|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
1109323|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
1109324|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
1109325|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
1109326|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
1109327|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
1109328|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
1109329|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
1109330|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
1109331|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
1109332|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
1109333|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
1109334|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
1109335|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
1109529|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
1109336|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
1109337|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
1109338|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
1109339|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
1109340|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
1109341|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
1109342|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
1109343|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
1109344|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
1109345|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
1109346|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
1109347|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
1109348|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
1109349|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
1109350|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
1109351|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
1109352|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
1109353|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
1109354|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
1109355|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
1109356|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
1109357|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
1109358|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
1109359|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
1109360|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
1109361|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
1109362|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
1109363|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
1109364|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
1109365|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
1109366|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
1109367|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
1109368|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
1109369|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
1109370|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
1109371|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
1109372|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
1109373|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
1109374|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
1109530|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
1109375|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
1109376|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
1109377|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
1109378|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
1109379|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
1109380|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
1109381|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
1109382|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
1109383|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
1109384|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
1109385|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
1109386|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
1109387|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
1109388|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
1109389|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
1109390|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
1109391|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
1109392|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
1109393|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
1109394|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
1109395|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
1109396|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
1109397|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
1109398|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
1109399|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
1109400|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
1109401|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
1109402|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
1109403|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
1109404|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
1109405|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
1109406|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
1109407|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
1109408|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
1109409|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
1109410|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
1109411|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
1109412|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
1109413|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
1109531|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
1109414|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
1109415|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
1109416|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
1109417|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
1109418|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
1109419|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
1109420|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
1109421|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
1109422|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
1109423|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
1109424|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
1109425|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
1109426|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
1109427|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
1109428|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
1109429|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
1109430|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
1109431|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
1109432|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
1109433|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
1109434|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
1109435|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
1109436|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
1109437|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
1109438|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
1109439|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
1109440|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
1109441|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
1109442|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
1109443|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
1109444|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
1109445|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
1109446|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
1109447|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
1109448|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
1109449|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
1109450|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
1109451|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
1109452|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
1109745|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
1109454|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
1109455|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
1109456|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
1109457|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
1109458|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
1109459|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
1109460|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
1109461|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
1109462|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
1109463|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
1109464|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
1109465|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
1109466|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
1109467|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
1109468|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
1109469|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
1109470|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
1109471|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
1109472|NCT00540592|E10|Reported Event|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
1109473|NCT00540592|E9|Reported Event|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
1109474|NCT00540592|E8|Reported Event|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
1109475|NCT00540592|E7|Reported Event|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
1109476|NCT00540592|E6|Reported Event|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
1109477|NCT00540592|E5|Reported Event|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
1109478|NCT00540592|E4|Reported Event|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
1109479|NCT00540592|E3|Reported Event|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
1109480|NCT00540592|E2|Reported Event|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
1109481|NCT00540592|E1|Reported Event|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
1109482|NCT00540579|B1|Baseline|Pomalidomide/Gemcitabine|All patients received gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was administered orally on days 1-21 at doses escalated from 2 mg to 10 mg daily.
1109483|NCT00540579|P1|Participant Flow|Pomalidomide/Gemcitabine|All patients received gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was administered orally on days 1-21 at doses escalated from 2 mg to 10 mg daily.
1109484|NCT00540579|O1|Outcome|Pomalidomide/Gemcitabine|All patients received gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was administered orally on days 1-21 at doses escalated from 2 mg to 10 mg daily.
1109485|NCT00540579|O1|Outcome|Pomalidomide/Gemcitabine|All patients received gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was administered orally on days 1-21 at doses escalated from 2 mg to 10 mg daily.
1109486|NCT00540579|E1|Reported Event|Pomalidomide/Gemcitabine|All patients received gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was administered orally on days 1-21 at doses escalated from 2 mg to 10 mg daily.
1109487|NCT00540514|B3|Baseline|Total|Total of all reporting groups
1109488|NCT00540514|B2|Baseline|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
1109504|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
1109489|NCT00540514|B1|Baseline|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
1109490|NCT00540514|P2|Participant Flow|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel (Taxol®) administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
1109491|NCT00540514|P1|Participant Flow|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel (ABRAXANE®) 100 mg/m^2 administered as an intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
1109492|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
1109493|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
1109494|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
1109495|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
1109553|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
1114314|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
1109496|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
1109497|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
1109498|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
1109499|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
1109500|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
1109501|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
1109502|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
1109503|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
1109523|NCT00540449|P2|Participant Flow|Efavirenz|600 mg once daily for 96 weeks.
1109524|NCT00540449|P1|Participant Flow|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
1109525|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
1109505|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
1109506|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
1109507|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
1109508|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
1109509|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
1109510|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
1109511|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
1109512|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
1109513|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
1109514|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
1109515|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
1109516|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
1109517|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
1109518|NCT00540514|E2|Reported Event|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
1109519|NCT00540514|E1|Reported Event|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
1109520|NCT00540449|B3|Baseline|Total|Total of all reporting groups
1109521|NCT00540449|B2|Baseline|Efavirenz|600 mg once daily for 96 weeks.
1109522|NCT00540449|B1|Baseline|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
1109532|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
1109533|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
1109534|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
1109535|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
1109536|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
1109537|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
1109538|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
1109539|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
1109540|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
1109541|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
1109542|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
1109543|NCT00540449|E2|Reported Event|Efavirenz|600 mg once daily for 96 weeks.
1109544|NCT00540449|E1|Reported Event|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
1109545|NCT00540436|B1|Baseline|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition).
1109546|NCT00540436|P1|Participant Flow|GSK1325760A|First Treatment Period: GSK1325760A 5 mg once a day. Second Treatment Period: GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition).
1109547|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
1109548|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
1109549|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
1109550|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
1109551|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
1109552|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
1109629|NCT00540293|O1|Outcome|Total|N=425 (Total: sum of all risk groups)
1114315|NCT00529542|O2|Outcome|Placebo|Placebo qd
1109554|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
1109555|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
1109556|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
1109557|NCT00540436|E1|Reported Event|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition).
1109558|NCT00540423|B3|Baseline|Total|Total of all reporting groups
1109559|NCT00540423|B2|Baseline|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
1109560|NCT00540423|B1|Baseline|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
1109561|NCT00540423|P3|Participant Flow|SB-497115-GR, Open-label|All participants who received placebo and SB-497115-GR in the double-blind phase and completed the phase continued to receive SB-497115-GR in the open-label phase (19 weeks for SB-497115-GR group and 26 weeks for placebo group; all participants received 26 weeks in total). Dose adjustment to 12.5, 25, or 50 mg/day was allowed based on the participant's platelet count.
1109562|NCT00540423|P2|Participant Flow|SB-497115-GR, Double-blind|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted to 25 mg or 12.5 mg/day at Week 3 based on the participant's platelet count and then continued up to Week 7.
1109563|NCT00540423|P1|Participant Flow|Placebo|Placebo 12.5 milligrams (mg) for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted to 25 mg or 12.5 mg/day at Week 3 based on the participant's platelet count and then continued up to Week 7
1109564|NCT00540423|O3|Outcome|SB-497115-GR 50 mg|Participants who received 50 mg of SB497511-GR on the PK sampling day
1109565|NCT00540423|O2|Outcome|SB-497115-GR 25 mg|Participants who received 25 mg of SB-497511-GR on the PK sampling day
1109566|NCT00540423|O1|Outcome|SB-497115-GR 12.5 mg|Participants who received 12.5 mg of SB-497511-GR on the PK sampling day
1109567|NCT00540423|O3|Outcome|SB-497115-GR 50 mg|Participants who received 50 mg of SB-497511-GR on the PK sampling day
1109568|NCT00540423|O2|Outcome|SB-497115-GR 25 mg|Participants who received 25 mg of SB497511-GR on the PK sampling day
1109569|NCT00540423|O1|Outcome|SB-497115-GR 12.5 mg|Participants who received 12.5 mg of SB-497511-GR on the PK sampling day
1109570|NCT00540423|O3|Outcome|SB-497115-GR 50 mg|Participants who received 50 mg of SB-497511-GR on the PK sampling day
1109571|NCT00540423|O2|Outcome|SB-497115-GR 25 mg|Participants who received 25 mg of SB-497511-GR on the PK sampling day
1109572|NCT00540423|O1|Outcome|SB-497115-GR 12.5 mg|Participants who received 12.5 mg of SB-497511-GR on the PK sampling day
1109573|NCT00540423|O3|Outcome|SB-497115-GR 50 mg|Participants who received 50 mg of SB-497115-GR on the PK sampling day
1109746|NCT00540124|O1|Outcome|Placebo|by mouth once a day
1109574|NCT00540423|O2|Outcome|SB-497115-GR 25 mg|Participants who received 25 mg of SB-497511-GR on the PK sampling day
1109575|NCT00540423|O1|Outcome|SB-497115-GR 12.5 mg|Participants who received 12.5 mg of SB-497115-GR on the PK sampling day
1109576|NCT00540423|O3|Outcome|SB-497115-GR 50 mg|Participants who received 50 mg of SB-497115-GR on the PK sampling day
1109577|NCT00540423|O2|Outcome|SB-497115-GR 25 mg|Participants who received 25 mg of SB-497115-GR on the PK sampling day
1109578|NCT00540423|O1|Outcome|SB-497115-GR 12.5 mg|Participants who received 12.5 mg of SB-497115-GR on the PK sampling day
1109579|NCT00540423|O3|Outcome|SB-497115-GR 50 mg|Participants who received 50 mg of SB-497115-GR on the PK sampling day
1109580|NCT00540423|O2|Outcome|SB-497115-GR 25 mg|Participants who received 25 mg of SB-497115-GR on the PK sampling day
1109581|NCT00540423|O1|Outcome|SB-497115-GR 12.5 mg|Participants who received 12.5 mg of SB-497115-GR on the PK sampling day
1109582|NCT00540423|O3|Outcome|SB-497115-GR 50 mg|Participants who received 50 mg of SB-497115-GR on the PK sampling day
1109583|NCT00540423|O2|Outcome|SB-497115-GR 25 mg|Participants who received 25 mg of SB-497115-GR on the PK sampling day
1109584|NCT00540423|O1|Outcome|SB-497115-GR 12.5 mg|Participants who received 12.5 mg of SB-497115-GR on the PK sampling day
1109585|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
1109586|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
1109587|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
1109588|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
1109589|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
1109590|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
1109591|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
1109592|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
1109593|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
1109594|NCT00540423|O2|Outcome|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
1109595|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
1109931|NCT00539591|O1|Outcome|Week 2|QoL assessment completed at Week 2.
1109596|NCT00540423|O2|Outcome|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
1109597|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
1109598|NCT00540423|O2|Outcome|SG-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
1109599|NCT00540423|O1|Outcome|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
1109600|NCT00540423|O2|Outcome|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
1109601|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
1109602|NCT00540423|O2|Outcome|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
1109603|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
1109604|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
1109605|NCT00540423|O2|Outcome|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
1109606|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
1109607|NCT00540423|O2|Outcome|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
1109608|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
1109609|NCT00540423|E3|Reported Event|SB-497115-GR Long-Term Phase|All participants who received placebo and SB-497115-GR in the double-blind phase and completed the phase continued to receive SB-497115-GR in the open-label phase (19 weeks for SB-497115-GR group and 26 weeks for placebo group; all participants received up to 26 weeks in total). Dose adjustment to 12.5, 25, or 50 mg/day was allowed based on the participant's platelet count
1109610|NCT00540423|E2|Reported Event|SB-497115-GR Short-Term (Double-Blind) Phase|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
1109611|NCT00540423|E1|Reported Event|Placebo Short-Term (Double-Blind) Phase|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
1109747|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
1109748|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
1109612|NCT00540293|B1|Baseline|Total Treatment Group (All Subjects Who Received Atorvastatin)|this patient group consists of dyslipidemia patients with various cardiovascular diseases (CVD)risk factors
1109613|NCT00540293|P1|Participant Flow|Total Treatment Group (All Subjects Who Received Atorvastatin)|this patient group consists of dyslipidemia patients with various cardiovascular diseases (CVD)risk factors
1109614|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
1109615|NCT00540293|O3|Outcome|Medium Risk|N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
1109616|NCT00540293|O2|Outcome|Low Risk|N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
1109617|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
1109618|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
1109619|NCT00540293|O3|Outcome|Medium Risk|N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
1109620|NCT00540293|O2|Outcome|Low Risk|N=29(Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
1109621|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
1109622|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
1109623|NCT00540293|O3|Outcome|Medium Risk|N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
1109624|NCT00540293|O2|Outcome|Low Risk|N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
1109625|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
1109626|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
1109627|NCT00540293|O3|Outcome|Medium Risk|N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
1109628|NCT00540293|O2|Outcome|Low Risk|N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
1109630|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
1109631|NCT00540293|O3|Outcome|Medium Risk|N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
1109632|NCT00540293|O2|Outcome|Low Risk|N=29(Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
1109633|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
1109634|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
1109635|NCT00540293|O3|Outcome|Medium Risk|N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
1109636|NCT00540293|O2|Outcome|Low Risk|N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
1109637|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
1109638|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
1109639|NCT00540293|O3|Outcome|Medium Risk|N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
1109640|NCT00540293|O2|Outcome|Low Risk|N=29(Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
1109641|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
1109642|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
1109643|NCT00540293|O3|Outcome|Medium Risk|N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
1109644|NCT00540293|O2|Outcome|Low Risk|N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
1109645|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
1109646|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
1109647|NCT00540293|O3|Outcome|Medium Risk|N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
1109648|NCT00540293|O2|Outcome|Low Risk|N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
1109649|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
1109650|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
1109749|NCT00540124|O1|Outcome|Placebo|by mouth once a day
1109651|NCT00540293|O3|Outcome|Medium Risk|N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
1109652|NCT00540293|O2|Outcome|Low Risk|N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
1109653|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
1109654|NCT00540293|E1|Reported Event|Total Treatment Group (All Subjects Who Received Atorvastatin)|this patient group consists of dyslipidemia patients with various cardiovascular diseases (CVD)risk factors
1109655|NCT00540228|B6|Baseline|Total|Total of all reporting groups
1109656|NCT00540228|B5|Baseline|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109657|NCT00540228|B4|Baseline|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109658|NCT00540228|B3|Baseline|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109659|NCT00540228|B2|Baseline|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109660|NCT00540228|B1|Baseline|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109661|NCT00540228|P5|Participant Flow|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109662|NCT00540228|P4|Participant Flow|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109663|NCT00540228|P3|Participant Flow|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109664|NCT00540228|P2|Participant Flow|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109932|NCT00539591|O9|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
1109665|NCT00540228|P1|Participant Flow|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109666|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109667|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109668|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109669|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109670|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109671|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109672|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109673|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109674|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109675|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109676|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109677|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109678|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109679|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109750|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
1109751|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
1109680|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109681|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109682|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109683|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109684|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109685|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109686|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109687|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109688|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109689|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109690|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109691|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1114316|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
1109692|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109693|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109694|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109695|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109696|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109697|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109698|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109699|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109700|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109701|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109702|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109703|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109704|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109705|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109706|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109707|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109708|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109709|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109710|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109711|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109712|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109713|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109714|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109715|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109716|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109717|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109718|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109933|NCT00539591|O8|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
1109934|NCT00539591|O7|Outcome|End of Therapy|QoL assessment completed at end of therapy.
1109719|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109720|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109721|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109722|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109723|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109724|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109725|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109726|NCT00540228|E5|Reported Event|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109727|NCT00540228|E4|Reported Event|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109728|NCT00540228|E3|Reported Event|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109729|NCT00540228|E2|Reported Event|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109730|NCT00540228|E1|Reported Event|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1109731|NCT00540124|B4|Baseline|Total|Total of all reporting groups
1109732|NCT00540124|B3|Baseline|Tamsulosin|0.2 mg by mouth once a day
1109733|NCT00540124|B2|Baseline|Tadalafil|5 mg by mouth once a day
1109734|NCT00540124|B1|Baseline|Placebo|by mouth once a day
1109735|NCT00540124|P3|Participant Flow|Tamsulosin|0.2 mg by mouth once a day
1109736|NCT00540124|P2|Participant Flow|Tadalafil|5 mg by mouth once a day
1109737|NCT00540124|P1|Participant Flow|Placebo|by mouth once a day
1109738|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
1109739|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
1109740|NCT00540124|O1|Outcome|Placebo|by mouth once a day
1109741|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
1109742|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
1109743|NCT00540124|O1|Outcome|Placebo|by mouth once a day
1109744|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
1109757|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
1109758|NCT00540124|O1|Outcome|Placebo|by mouth once a day
1109759|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
1109760|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
1109761|NCT00540124|O1|Outcome|Placebo|by mouth once a day
1109762|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
1109763|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
1109764|NCT00540124|O1|Outcome|Placebo|by mouth once a day
1109765|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
1109766|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
1109767|NCT00540124|O1|Outcome|Placebo|by mouth once a day
1109768|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
1109769|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
1109770|NCT00540124|O1|Outcome|Placebo|by mouth once a day
1109771|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
1109772|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
1109773|NCT00540124|O1|Outcome|Placebo|by mouth once a day
1109774|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
1109775|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
1109776|NCT00540124|O1|Outcome|Placebo|by mouth once a day
1109777|NCT00540124|E3|Reported Event|Tamsulosin|0.2 mg by mouth once a day
1109778|NCT00540124|E2|Reported Event|Tadalafil|5 mg by mouth once a day
1109779|NCT00540124|E1|Reported Event|Placebo|by mouth once a day
1109780|NCT00540046|B3|Baseline|Total|Total of all reporting groups
1109781|NCT00540046|B2|Baseline|B/Delayed|"The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure.~Copper T 380A IUD: Copper T 380A IUD will be placed at the 2-4 week post-operative visit."
1109782|NCT00540046|B1|Baseline|A/Immediate|"The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure~Copper T 380A IUD: Copper T 380A IUD will be placed immediately following the procedure."
1109783|NCT00540046|P2|Participant Flow|B/Delayed|"The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure.~Copper T 380A IUD: Copper T 380A IUD will be placed at the 2-4 week post-operative visit."
1109935|NCT00539591|O6|Outcome|Week 24|QoL assessment completed at Week 24.
1109784|NCT00540046|P1|Participant Flow|A/Immediate|"The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure~Copper T 380A IUD: Copper T 380A IUD will be placed immediately following the procedure."
1109785|NCT00540046|O2|Outcome|B/Delayed|"The delayed group had the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure.~IUD status was known six months post-abortion."
1109786|NCT00540046|O1|Outcome|A/Immediate|"The patients in the immediate arm had the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure.~IUD status was known six months post-abortion and insertion."
1109787|NCT00540046|O2|Outcome|B/Delayed|"The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure.~Copper T 380A IUD: Copper T 380A IUD will be placed at the 2-4 week post-operative visit."
1109788|NCT00540046|O1|Outcome|A/Immediate|"The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure~Copper T 380A IUD: Copper T 380A IUD will be placed immediately following the procedure."
1109789|NCT00540046|E2|Reported Event|B/Delayed|"The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure.~Copper T 380A IUD: Copper T 380A IUD will be placed at the 2-4 week post-operative visit."
1109790|NCT00540046|E1|Reported Event|A/Immediate|"The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure~Copper T 380A IUD: Copper T 380A IUD will be placed immediately following the procedure."
1109791|NCT00539994|B4|Baseline|Total|Total of all reporting groups
1109792|NCT00539994|B3|Baseline|Placebo|Placebo 200 mg BID for 5 days
1109793|NCT00539994|B2|Baseline|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
1109794|NCT00539994|B1|Baseline|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
1109795|NCT00539994|P3|Participant Flow|Placebo|Placebo 200 mg BID for 5 days
1109796|NCT00539994|P2|Participant Flow|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
1109797|NCT00539994|P1|Participant Flow|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
1109798|NCT00539994|O4|Outcome|Total|Total of all groups
1109799|NCT00539994|O3|Outcome|Placebo|Placebo 200 mg BID for 5 days
1109800|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
1109801|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
1109802|NCT00539994|O1|Outcome|MRSA|Methicillin Resistant S. aureus.
1109803|NCT00539994|O2|Outcome|Positive Pharyngeal Culture for S. Aureus|Subjects who tested positive for S. aureus in the pharyngeal region.
1109804|NCT00539994|O1|Outcome|Positive Nasal Culture for S. Aureus|Screened subjects positive for S. aureus
1109805|NCT00539994|O4|Outcome|Total|Total of all Groups
1109806|NCT00539994|O3|Outcome|Placebo|Placebo 200 mg BID for 5 days
1109807|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
1109808|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 Days and Placebo 2 days
1109809|NCT00539994|O3|Outcome|Placebo|Placebo 200 mg BID for 5 days
1109810|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
1109811|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
1109812|NCT00539994|O3|Outcome|Placebo|Placebo 200 mg BID for 5 days
1109813|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
1109814|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
1109815|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
1109816|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
1109817|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
1109818|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
1109819|NCT00539994|O3|Outcome|Placebo|Placebo 200 mg BID for 5 days
1109820|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
1109821|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
1109822|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
1109823|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
1109824|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
1109825|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
1109826|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
1109827|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
1109828|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
1109829|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
1109830|NCT00539994|E3|Reported Event|Placebo|Placebo 200 mg BID for 5 days
1109831|NCT00539994|E2|Reported Event|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
1109832|NCT00539994|E1|Reported Event|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
1109833|NCT00539942|B3|Baseline|Total|Total of all reporting groups
1109834|NCT00539942|B2|Baseline|Fondaparinux (Arixtra)|Patients randomized to treatment arm will initiate ARIXTRA treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5mg/day for a total of 21 consecutive days (this includes both while in the hospital and after hospital discharge)
1109936|NCT00539591|O5|Outcome|Week 12|QoL assessment completed at Week 12.
1109835|NCT00539942|B1|Baseline|Intermittent Compression Devices|Patients will receive standard intermittent compression devices (ICD's) during entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.
1109836|NCT00539942|P2|Participant Flow|Arixtra (Fondaparinux Sodium)|Patients randomized to treatment arm will initiate ARIXTRA treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5mg/day for a total of 21 consecutive days (this includes both while in the hospital and after hospital discharge)
1109837|NCT00539942|P1|Participant Flow|Intermittent Compression Devices|Patients will receive standard intermittent compression devices (ICD's) during entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.
1109838|NCT00539942|O2|Outcome|Arixtra (Fondaparinux Sodium)|Patients randomized to the Arixtra arm will initiate treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5 mg/day for a total of 21 consecutive days (including hospitalization and after hospital discharge)
1109839|NCT00539942|O1|Outcome|Intermittent Compression Devices|Patients will receive intermittent compression devices (ICD's) during the entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.
1109840|NCT00539942|O2|Outcome|Arixtra (Fondaparinux Sodium)|Patients randomized to the Arixtra arm will initiate treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5 mg/day for a total of 21 consecutive days (including hospitalization and after hospital discharge)
1109841|NCT00539942|O1|Outcome|Intermittent Compression Devices|Patients will receive intermittent compression devices (ICD's) during the entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.
1109842|NCT00539942|E2|Reported Event|Arixtra (Fondaparinux Sodium)|Patients randomized to treatment arm will initiate ARIXTRA treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5mg/day for a total of 21 consecutive days (this includes both while in the hospital and after hospital discharge)
1109843|NCT00539942|E1|Reported Event|Intermittent Compression Devices|Patients will receive standard intermittent compression devices (ICD's) during entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.
1109844|NCT00539864|B3|Baseline|Total|Total of all reporting groups
1109845|NCT00539864|B2|Baseline|TIV (Fluzone)|"Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~45μg total~(Fluzone, sanofi pasteur)"
1109846|NCT00539864|B1|Baseline|FluBlok|"Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~135μg total"
1109847|NCT00539864|P2|Participant Flow|TIV (Fluzone)|"Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~45μg total~(Fluzone, sanofi pasteur)"
1109898|NCT00539591|O2|Outcome|Week 4|Psychological assessment completed at Week 4
1109848|NCT00539864|P1|Participant Flow|FluBlok|"Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~135μg total"
1109849|NCT00539864|O2|Outcome|TIV (Fluzone)|"Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~45μg total~(Fluzone, sanofi pasteur)"
1109850|NCT00539864|O1|Outcome|FluBlok|"Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~135μg total"
1109851|NCT00539864|O2|Outcome|TIV (Fluzone)|"Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~45μg total~(Fluzone, sanofi pasteur)"
1109852|NCT00539864|O1|Outcome|FluBlok|"Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~135μg total"
1109853|NCT00539864|O2|Outcome|TIV (Fluzone)|"Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~45μg total~(Fluzone, sanofi pasteur)"
1109854|NCT00539864|O1|Outcome|FluBlok|"Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~135μg total"
1109855|NCT00539864|O2|Outcome|TIV (Fluzone)|"Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~45μg total~(Fluzone, sanofi pasteur)"
1109856|NCT00539864|O1|Outcome|FluBlok|"Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~135μg total"
1109937|NCT00539591|O4|Outcome|Week 8|QoL assessment completed at Week 8.
1109938|NCT00539591|O3|Outcome|Week 4|QoL assessment completed at Week 4.
1109857|NCT00539864|E2|Reported Event|TIV (Fluzone)|"Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~45μg total~(Fluzone, sanofi pasteur)"
1109858|NCT00539864|E1|Reported Event|FluBlok|"Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~135μg total"
1109859|NCT00539734|B1|Baseline|Ranibizumab Group|Ranibizumab 0.5 mg (Lucentis®; Novartis Pharma AG, Basel, Switzerland) was injected intravitreally at 4.0 mm from the limbus in phakic eyes and at 3.5 mm in pseudophakic eyes. Re-treatment with the interval of a month apart is considered under the retinal condition.
1109860|NCT00539734|P1|Participant Flow|Ranibizumab Group|Ranibizumab 0.5 mg (Lucentis®; Novartis Pharma AG, Basel, Switzerland) was injected intravitreally at 4.0 mm from the limbus in phakic eyes and at 3.5 mm in pseudophakic eyes. Re-treatment with the interval of a month apart is considered under the retinal condition.
1109861|NCT00539734|O1|Outcome|Ranibizumab Group|Ranibizumab 0.5 mg (Lucentis®; Novartis Pharma AG, Basel, Switzerland) was injected intravitreally at 4.0 mm from the limbus in phakic eyes and at 3.5 mm in pseudophakic eyes. Re-treatment with the interval of a month apart is considered under the retinal condition.
1109862|NCT00539734|O1|Outcome|Ranibizumab Group|Ranibizumab 0.5 mg (Lucentis®; Novartis Pharma AG, Basel, Switzerland) was injected intravitreally at 4.0 mm from the limbus in phakic eyes and at 3.5 mm in pseudophakic eyes. Re-treatment with the interval of a month apart is considered under the retinal condition.
1109863|NCT00539734|E1|Reported Event|Ranibizumab Group|Ranibizumab 0.5 mg (Lucentis®; Novartis Pharma AG, Basel, Switzerland) was injected intravitreally at 4.0 mm from the limbus in phakic eyes and at 3.5 mm in pseudophakic eyes. Re-treatment with the interval of a month apart is considered under the retinal condition.
1109864|NCT00539695|B1|Baseline|IL2 Administration|"SCHEDULE OF IL-2 ADMINISTRATION: Patients will receive a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT.~Time will be measured as 'week beginning with first IL-2 injection.'~T cell Induction via IL-2 to reduce GVHD~IL-2: IL2 Administration:~Patients will be given a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT. If the patient has not developed >grade I side effects to IL-2 and has not developed >grade I GVHD then the patient may continue the IL-2 for 6 additional weeks. Time will be measured as ‘week beginning with first IL-2 injection."
1109865|NCT00539695|P1|Participant Flow|IL2 Administration|"SCHEDULE OF IL-2 ADMINISTRATION: Patients will receive a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT.~Time will be measured as 'week beginning with first IL-2 injection.'~T cell Induction via IL-2 to reduce GVHD~IL-2: IL2 Administration:~Patients will be given a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT. If the patient has not developed >grade I side effects to IL-2 and has not developed >grade I GVHD then the patient may continue the IL-2 for 6 additional weeks. Time will be measured as ‘week beginning with first IL-2 injection."
1109899|NCT00539591|O1|Outcome|Pretherapy|Psychological assessment completed before start of therapy.
1109900|NCT00539591|O8|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
1109901|NCT00539591|O7|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
1109902|NCT00539591|O6|Outcome|End of Therapy|QoL assessment completed at end of therapy.
1109903|NCT00539591|O5|Outcome|Week 24|QoL assessment completed at Week 24.
1109904|NCT00539591|O4|Outcome|Week 12|QoL assessment completed at Week 12.
1109905|NCT00539591|O3|Outcome|Week 8|QoL assessment completed at Week 8.
1109906|NCT00539591|O2|Outcome|Week 4|QoL assessment completed at Week 4.
1109866|NCT00539695|O1|Outcome|IL2 Administration|"SCHEDULE OF IL-2 ADMINISTRATION: Patients will receive a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT.~Time will be measured as 'week beginning with first IL-2 injection.'~T cell Induction via IL-2 to reduce GVHD~IL-2: IL2 Administration:~Patients will be given a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT. If the patient has not developed >grade I side effects to IL-2 and has not developed >grade I GVHD then the patient may continue the IL-2 for 6 additional weeks. Time will be measured as ‘week beginning with first IL-2 injection."
1109867|NCT00539695|E1|Reported Event|IL2 Administration|"SCHEDULE OF IL-2 ADMINISTRATION: Patients will receive a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT.~Time will be measured as 'week beginning with first IL-2 injection.'~T cell Induction via IL-2 to reduce GVHD~IL-2: IL2 Administration:~Patients will be given a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT. If the patient has not developed >grade I side effects to IL-2 and has not developed >grade I GVHD then the patient may continue the IL-2 for 6 additional weeks. Time will be measured as ‘week beginning with first IL-2 injection."
1109868|NCT00539617|B1|Baseline|FOLFOX and Erlotinib|Single arm study of FOLFOX6 plus Erlotinib
1109869|NCT00539617|P1|Participant Flow|FOLFOX and Erlotinib|Single arm study of FOLFOX6 plus Erlotinib
1109870|NCT00539617|O1|Outcome|FOLFOX and Erlotinib|Single arm study of FOLFOX6 plus Erlotinib
1109871|NCT00539617|O1|Outcome|FOLFOX and Erlotinib|Single arm study of FOLFOX6 plus Erlotinib
1109872|NCT00539617|E1|Reported Event|FOLFOX and Erlotinib|Single arm study of FOLFOX6 plus Erlotinib
1109873|NCT00539591|B4|Baseline|Total|Total of all reporting groups
1109939|NCT00539591|O2|Outcome|Week 2|QoL assessment completed at Week 2.
1109874|NCT00539591|B3|Baseline|Temozolomide/Peginterferon ɑ-2b Without Measureable Disease|"Stratum B2: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants without measurable disease~Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks. Stratum B2 (no measurable disease) proceeded with 7 courses as outlined."
1109875|NCT00539591|B2|Baseline|Temozolomide/Peginterferon ɑ-2b With Measureable Disease|"Stratum B1: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants with measurable disease~Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks."
1109876|NCT00539591|B1|Baseline|Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b|"Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB~Participants received recombinant interferon ɑ-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon ɑ-2b 1 mcg/kg subcutaneously once a week for 48 weeks."
1109877|NCT00539591|P3|Participant Flow|Temozolomide/Peginterferon ɑ-2b Without Measureable Disease|"Stratum B2: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants without measurable disease~Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks. Stratum B2 (no measurable disease) proceeded with 7 courses as outlined."
1109878|NCT00539591|P2|Participant Flow|Temozolomide/Peginterferon ɑ-2b With Measureable Disease|"Stratum B1: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants with measurable disease~Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks."
1109879|NCT00539591|P1|Participant Flow|Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b|"Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB~Participants received recombinant interferon ɑ-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon ɑ-2b 1 mcg/kg subcutaneously once a week for 48 weeks."
1109880|NCT00539591|O5|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
1109881|NCT00539591|O4|Outcome|End of Therapy|QoL assessment completed at end of therapy.
1109882|NCT00539591|O3|Outcome|Week 24|Psychological assessment completed at Week 24
1109883|NCT00539591|O2|Outcome|Week 4|Psychological assessment completed at Week 4
1109884|NCT00539591|O1|Outcome|Pretherapy|Psychological assessment completed before start of therapy.
1109885|NCT00539591|O5|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
1109886|NCT00539591|O4|Outcome|End of Therapy|QoL assessment completed at end of therapy.
1109887|NCT00539591|O3|Outcome|Week 24|Psychological assessment completed at Week 24
1109888|NCT00539591|O2|Outcome|Week 4|Psychological assessment completed at Week 4
1109889|NCT00539591|O1|Outcome|Pretherapy|Psychological assessment completed before start of therapy.
1109890|NCT00539591|O5|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
1109891|NCT00539591|O4|Outcome|End of Therapy|QoL assessment completed at end of therapy.
1109892|NCT00539591|O3|Outcome|Week 24|Psychological assessment completed at Week 24
1109893|NCT00539591|O2|Outcome|Week 4|Psychological assessment completed at Week 4
1109894|NCT00539591|O1|Outcome|Pretherapy|Psychological assessment completed before start of therapy.
1109895|NCT00539591|O5|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
1109896|NCT00539591|O4|Outcome|End of Therapy|QoL assessment completed at end of therapy.
1109897|NCT00539591|O3|Outcome|Week 24|Psychological assessment completed at Week 24
1109907|NCT00539591|O1|Outcome|Week 2|QoL assessment completed at Week 2.
1109908|NCT00539591|O8|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
1109909|NCT00539591|O7|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
1109910|NCT00539591|O6|Outcome|End of Therapy|QoL assessment completed at end of therapy.
1109911|NCT00539591|O5|Outcome|Week 24|QoL assessment completed at Week 24.
1109912|NCT00539591|O4|Outcome|Week 12|QoL assessment completed at Week 12.
1109913|NCT00539591|O3|Outcome|Week 8|QoL assessment completed at Week 8.
1109914|NCT00539591|O2|Outcome|Week 4|QoL assessment completed at Week 4.
1109915|NCT00539591|O1|Outcome|Week 2|QoL assessment completed at Week 2.
1109916|NCT00539591|O8|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
1109917|NCT00539591|O7|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
1109918|NCT00539591|O6|Outcome|End of Therapy|QoL assessment completed at end of therapy.
1109919|NCT00539591|O5|Outcome|Week 24|QoL assessment completed at Week 24.
1109920|NCT00539591|O4|Outcome|Week 12|QoL assessment completed at Week 12.
1109921|NCT00539591|O3|Outcome|Week 8|QoL assessment completed at Week 8.
1109922|NCT00539591|O2|Outcome|Week 4|QoL assessment completed at Week 4.
1109923|NCT00539591|O1|Outcome|Week 2|QoL assessment completed at Week 2.
1109924|NCT00539591|O8|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
1109925|NCT00539591|O7|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
1109926|NCT00539591|O6|Outcome|End of Therapy|QoL assessment completed at end of therapy.
1109927|NCT00539591|O5|Outcome|Week 24|QoL assessment completed at Week 24.
1109928|NCT00539591|O4|Outcome|Week 12|QoL assessment completed at Week 12.
1109929|NCT00539591|O3|Outcome|Week 8|QoL assessment completed at Week 8.
1109930|NCT00539591|O2|Outcome|Week 4|QoL assessment completed at Week 4.
1109941|NCT00539591|O9|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
1109942|NCT00539591|O8|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
1109943|NCT00539591|O7|Outcome|End of Therapy|QoL assessment completed at end of therapy.
1109944|NCT00539591|O6|Outcome|Week 24|QoL assessment completed at Week 24.
1109945|NCT00539591|O5|Outcome|Week 12|QoL assessment completed at Week 12.
1109946|NCT00539591|O4|Outcome|Week 8|QoL assessment completed at Week 8.
1109947|NCT00539591|O3|Outcome|Week 4|QoL assessment completed at Week 4.
1109948|NCT00539591|O2|Outcome|Week 2|QoL assessment completed at Week 2.
1109949|NCT00539591|O1|Outcome|Pretherapy|QoL assessment completed before start of therapy.
1109950|NCT00539591|O9|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
1109951|NCT00539591|O8|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
1109952|NCT00539591|O7|Outcome|End of Therapy|QoL assessment completed at end of therapy.
1109953|NCT00539591|O6|Outcome|Week 24|QoL assessment completed at Week 24.
1109954|NCT00539591|O5|Outcome|Week 12|QoL assessment completed at Week 12.
1109955|NCT00539591|O4|Outcome|Week 8|QoL assessment completed at Week 8.
1109956|NCT00539591|O3|Outcome|Week 4|QoL assessment completed at Week 4.
1109957|NCT00539591|O2|Outcome|Week 2|QoL assessment completed at Week 2.
1109958|NCT00539591|O1|Outcome|Pretherapy|QoL assessment completed before start of therapy.
1109959|NCT00539591|O9|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
1109960|NCT00539591|O8|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
1109961|NCT00539591|O7|Outcome|End of Therapy|QoL assessment completed at end of therapy.
1109962|NCT00539591|O6|Outcome|Week 24|QoL assessment completed at Week 24.
1109963|NCT00539591|O5|Outcome|Week 12|QoL assessment completed at Week 12.
1109964|NCT00539591|O4|Outcome|Week 8|QoL assessment completed at Week 8.
1109965|NCT00539591|O3|Outcome|Week 4|QoL assessment completed at Week 4.
1109966|NCT00539591|O2|Outcome|Week 2|QoL assessment completed at Week 2.
1109967|NCT00539591|O1|Outcome|Pretherapy|QoL assessment completed before start of therapy.
1109968|NCT00539591|O1|Outcome|Interferon ɑ-2b|Participants who received interferon ɑ-2b and had pharmacokinetic studies performed are included.
1109969|NCT00539591|O1|Outcome|Interferon ɑ-2b|Participants who received interferon ɑ-2b and had pharmacokinetic studies performed are included.
1109970|NCT00539591|O1|Outcome|Peginterferon ɑ-2b/Non-Pegylated Interferon ɑ-2b|Stratum A participants who received interferon ɑ-2b and had pharmacokinetic studies performed are included.
1109971|NCT00539591|O1|Outcome|Peginterferon ɑ-2b/Non-Pegylated Interferon ɑ-2b|Stratum A participants who received interferon ɑ-2b and had pharmacokinetic studies performed are included.
1109972|NCT00539591|O1|Outcome|Peginterferon ɑ-2b/Non-Pegylated Interferon ɑ-2b|Stratum A participants who received pegylated interferon ɑ-2b and had pharmacokinetic studies performed are included.
1110117|NCT00539110|B2|Baseline|Ramelteon First, Then Zolpidem|dosed at 2200 and 0200 per the feeding tube
1109973|NCT00539591|O1|Outcome|Peginterferon ɑ-2b/Non-Pegylated Interferon ɑ-2b|Stratum A participants who received pegylated interferon ɑ-2b and had pharmacokinetic studies performed are included.
1109974|NCT00539591|O1|Outcome|Peginterferon ɑ-2b/Non-Pegylated Interferon ɑ-2b|Stratum A participants who received pegylated interferon ɑ-2b and had pharmacokinetic studies performed are included.
1109975|NCT00539591|O2|Outcome|Week 28 - Steady State|Stratum A participants who received pegylated interferon ɑ-2b and had pharmacokinetic studies performed.
1109976|NCT00539591|O1|Outcome|Week 5 - First Dose|Stratum A participants who received pegylated interferon ɑ-2b and had pharmacokinetic studies performed are included.
1109977|NCT00539591|O1|Outcome|Peginterferon ɑ-2b/Non-Pegylated Interferon ɑ-2b|Stratum A participants who received pegylated interferon ɑ-2b and had pharmacokinetic studies performed are included.
1109978|NCT00539591|O1|Outcome|Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b|"Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB~Participants received recombinant interferon ɑ-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon ɑ-2b 1 mcg/kg subcutaneously once a week for 48 weeks."
1109979|NCT00539591|O1|Outcome|Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b|"Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB~Participants received recombinant interferon ɑ-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon ɑ-2b 1 mcg/kg subcutaneously once a week for 48 weeks."
1109980|NCT00539591|O2|Outcome|Temozolomide/Peginterferon ɑ-2b Without Measureable Disease|"Stratum B2: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants without measurable disease~Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks. Stratum B2 (no measurable disease) proceeded with 7 courses as outlined."
1109981|NCT00539591|O1|Outcome|Temozolomide/Peginterferon ɑ-2b With Measureable Disease|"Stratum B1: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants with measurable disease~Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks."
1109982|NCT00539591|O1|Outcome|Stratum B1|"Stratum B: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants, divided into 2 groups based on presence (B1) or absence (B2) of measurable disease~Stratum B1 had presence of measurable disease. Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks.~Interventions: Temozolomide, peginterferon ɑ-2b"
1110193|NCT00538902|O2|Outcome|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
1114317|NCT00529542|O2|Outcome|Placebo|Placebo qd
1109983|NCT00539591|E3|Reported Event|Temozolomide/Peginterferon ɑ-2b Without Measureable Disease|"Stratum B2: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants without measurable disease~Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks. Stratum B2 (no measurable disease) proceeded with 7 courses as outlined."
1109984|NCT00539591|E2|Reported Event|Temozolomide/Peginterferon ɑ-2b With Measureable Disease|"Stratum B1: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants with measurable disease~Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks."
1109985|NCT00539591|E1|Reported Event|Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b|"Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB~Participants received recombinant interferon ɑ-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon ɑ-2b 1 mcg/kg subcutaneously once a week for 48 weeks."
1109986|NCT00539539|B3|Baseline|Total|Total of all reporting groups
1109987|NCT00539539|B2|Baseline|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
1109988|NCT00539539|B1|Baseline|Feedback On|Automated real-time feedback on CPR Process activated
1109989|NCT00539539|P2|Participant Flow|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
1109990|NCT00539539|P1|Participant Flow|Feedback On|Automated real-time feedback on CPR Process activated
1109991|NCT00539539|O2|Outcome|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
1109992|NCT00539539|O1|Outcome|Feedback On|Automated real-time feedback on CPR Process activated
1109993|NCT00539539|O2|Outcome|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
1109994|NCT00539539|O1|Outcome|Feedback On|Automated real-time feedback on CPR Process activated
1109995|NCT00539539|O2|Outcome|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
1109996|NCT00539539|O1|Outcome|Feedback On|Automated real-time feedback on CPR Process activated
1109997|NCT00539539|O2|Outcome|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
1109998|NCT00539539|O1|Outcome|Feedback On|Automated real-time feedback on CPR Process activated
1109999|NCT00539539|O2|Outcome|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
1110000|NCT00539539|O1|Outcome|Feedback On|Automated real-time feedback on CPR Process activated
1110001|NCT00539539|O2|Outcome|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
1110002|NCT00539539|O1|Outcome|Feedback On|Automated real-time feedback on CPR Process activated
1110003|NCT00539539|O2|Outcome|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
1110004|NCT00539539|O1|Outcome|Feedback On|Automated real-time feedback on CPR Process activated
1110590|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
1110005|NCT00539539|O2|Outcome|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
1110006|NCT00539539|O1|Outcome|Feedback On|Automated real-time feedback on CPR Process activated
1110007|NCT00539539|E2|Reported Event|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
1110008|NCT00539539|E1|Reported Event|Feedback On|Automated real-time feedback on CPR Process activated
1110009|NCT00539526|B4|Baseline|Total|Total of all reporting groups
1110010|NCT00539526|B3|Baseline|Latanoprost 0.005%|latanoprost 0.005%
1110011|NCT00539526|B2|Baseline|Travoprost 0.004%|travoprost 0.004%
1110012|NCT00539526|B1|Baseline|Bimatoprost 0.03%|bimatoprost 0.03%
1110013|NCT00539526|P3|Participant Flow|Latanoprost 0.005%|latanoprost 0.005%
1110014|NCT00539526|P2|Participant Flow|Travoprost 0.004%|travoprost 0.004%
1110015|NCT00539526|P1|Participant Flow|Bimatoprost 0.03%|bimatoprost 0.03%
1110016|NCT00539526|O3|Outcome|Latanoprost 0.005%|latanoprost 0.005%
1110017|NCT00539526|O2|Outcome|Travoprost 0.004%|travoprost 0.004%
1110018|NCT00539526|O1|Outcome|Bimatoprost 0.03%|bimatoprost 0.03%
1110019|NCT00539526|O3|Outcome|Latanoprost 0.005%|latanoprost 0.005%
1110020|NCT00539526|O2|Outcome|Travoprost 0.004%|travoprost 0.004%
1110021|NCT00539526|O1|Outcome|Bimatoprost 0.03%|bimatoprost 0.03%
1110022|NCT00539526|O3|Outcome|Latanoprost 0.005%|latanoprost 0.005%
1110023|NCT00539526|O2|Outcome|Travoprost 0.004%|travoprost 0.004%
1110024|NCT00539526|O1|Outcome|Bimatoprost 0.03%|bimatoprost 0.03%
1110025|NCT00539526|E3|Reported Event|Latanoprost 0.005%|latanoprost 0.005%
1110026|NCT00539526|E2|Reported Event|Travoprost 0.004%|travoprost 0.004%
1110027|NCT00539526|E1|Reported Event|Bimatoprost 0.03%|bimatoprost 0.03%
1110028|NCT00539513|B3|Baseline|Total|Total of all reporting groups
1110029|NCT00539513|B2|Baseline|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks"
1110030|NCT00539513|B1|Baseline|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks"
1110031|NCT00539513|P2|Participant Flow|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks"
1110118|NCT00539110|B1|Baseline|Zolpidem First, Then Ramelteon|dosed at 2200 and 0200 per the feeding tube
1110321|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110032|NCT00539513|P1|Participant Flow|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks"
1110033|NCT00539513|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks"
1110034|NCT00539513|O1|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks"
1110035|NCT00539513|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks"
1110036|NCT00539513|O1|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks"
1110037|NCT00539513|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks"
1110038|NCT00539513|O1|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks"
1110039|NCT00539513|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks"
1110040|NCT00539513|O1|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks"
1110041|NCT00539513|E2|Reported Event|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks"
1110591|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
1110042|NCT00539513|E1|Reported Event|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks"
1110043|NCT00539305|B3|Baseline|Total|Total of all reporting groups
1110044|NCT00539305|B2|Baseline|Placebo Group|Placebo gel : applied topically daily for six months
1110045|NCT00539305|B1|Baseline|Treatment Group|"Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl~testosterone gel : 50-100mg applied topically daily for six months"
1110046|NCT00539305|P2|Participant Flow|Placebo Group|Placebo gel : applied topically daily for six months
1110047|NCT00539305|P1|Participant Flow|Treatment Group|"Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl~testosterone gel : 50-100mg applied topically daily for six months"
1110048|NCT00539305|O2|Outcome|Placebo Group|Placebo gel : applied topically daily for six months
1110049|NCT00539305|O1|Outcome|Treatment Group|"Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl~testosterone gel : 50-100mg applied topically daily for six months"
1110050|NCT00539305|O2|Outcome|Placebo Group|Placebo gel : applied topically daily for six months
1110051|NCT00539305|O1|Outcome|Treatment Group|"Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl~testosterone gel : 50-100mg applied topically daily for six months"
1110052|NCT00539305|O2|Outcome|Placebo Group|Placebo gel : applied topically daily for six months
1110053|NCT00539305|O1|Outcome|Treatment Group|"Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl~testosterone gel : 50-100mg applied topically daily for six months"
1110054|NCT00539305|O2|Outcome|Placebo Group|Placebo gel : applied topically daily for six months
1110055|NCT00539305|O1|Outcome|Treatment Group|"Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl~testosterone gel : 50-100mg applied topically daily for six months"
1110056|NCT00539305|E2|Reported Event|Placebo Group|Placebo gel : applied topically daily for six months
1110057|NCT00539305|E1|Reported Event|Treatment Group|"Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl~testosterone gel : 50-100mg applied topically daily for six months"
1110058|NCT00539279|B3|Baseline|Total|Total of all reporting groups
1110059|NCT00539279|B2|Baseline|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
1110060|NCT00539279|B1|Baseline|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
1110061|NCT00539279|P2|Participant Flow|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
1110062|NCT00539279|P1|Participant Flow|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
1110063|NCT00539279|O2|Outcome|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
1111039|NCT00537095|O2|Outcome|PLACEBO|PLACEBO
1110064|NCT00539279|O1|Outcome|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
1110065|NCT00539279|O2|Outcome|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
1110066|NCT00539279|O1|Outcome|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
1110067|NCT00539279|O2|Outcome|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
1110068|NCT00539279|O1|Outcome|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
1110069|NCT00539279|O2|Outcome|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
1110070|NCT00539279|O1|Outcome|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
1110071|NCT00539279|O2|Outcome|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
1110072|NCT00539279|O1|Outcome|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
1110073|NCT00539279|O2|Outcome|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
1110074|NCT00539279|O1|Outcome|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
1110075|NCT00539279|O2|Outcome|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
1110076|NCT00539279|O1|Outcome|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
1110077|NCT00539279|E2|Reported Event|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
1110078|NCT00539279|E1|Reported Event|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
1110079|NCT00539240|B4|Baseline|Total|Total of all reporting groups
1110080|NCT00539240|B3|Baseline|AcipHex 20 mg Once, Placebo Once, Nortriptyline|"AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily~Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime"
1110081|NCT00539240|B2|Baseline|AcipHex 20 mg Once Daily and BID Placebo|"AcipHex 20 mg once daily and BID placebo~Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime"
1110082|NCT00539240|B1|Baseline|AciPhex 20 mg BID and Once Daily Placebo|"AciPhex 20 mg BID and once daily placebo~Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime"
1110083|NCT00539240|P3|Participant Flow|Arm 3|"AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily~Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime"
1110084|NCT00539240|P2|Participant Flow|Arm 2|"AcipHex 20 mg once daily and BID placebo~Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime"
1110085|NCT00539240|P1|Participant Flow|Arm 1|"AciPhex 20 mg BID and once daily placebo~Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime"
1110086|NCT00539240|O3|Outcome|Arm 3|"AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily~Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime"
1110087|NCT00539240|O2|Outcome|Arm 2|"AcipHex 20 mg once daily and BID placebo~Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime"
1110088|NCT00539240|O1|Outcome|Arm 1|"AciPhex 20 mg BID and once daily placebo~Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime"
1110312|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110089|NCT00539240|O3|Outcome|Arm 3|"AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily~Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime"
1110090|NCT00539240|O2|Outcome|Arm 2|"AcipHex 20 mg once daily and BID placebo~Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime"
1110091|NCT00539240|O1|Outcome|Arm 1|"AciPhex 20 mg BID and once daily placebo~Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime"
1110092|NCT00539240|O3|Outcome|Arm 3|"AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily~Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime"
1110093|NCT00539240|O2|Outcome|Arm 2|"AcipHex 20 mg once daily and BID placebo~Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime"
1110094|NCT00539240|O1|Outcome|Arm 1|"AciPhex 20 mg BID and once daily placebo~Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime"
1110095|NCT00539240|O3|Outcome|Arm 3|"AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily~Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime"
1110096|NCT00539240|O2|Outcome|Arm 2|"AcipHex 20 mg once daily and BID placebo~Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime"
1110097|NCT00539240|O1|Outcome|Arm 1|"AciPhex 20 mg BID and once daily placebo~Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime"
1110098|NCT00539240|E3|Reported Event|Arm 3|"AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily~Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime"
1110099|NCT00539240|E2|Reported Event|Arm 2|"AcipHex 20 mg once daily and BID placebo~Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime"
1110100|NCT00539240|E1|Reported Event|Arm 1|"AciPhex 20 mg BID and once daily placebo~Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime"
1110102|NCT00539188|B2|Baseline|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks"
1110103|NCT00539188|B1|Baseline|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks"
1110104|NCT00539188|P2|Participant Flow|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks"
1110105|NCT00539188|P1|Participant Flow|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks"
1110106|NCT00539188|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks"
1110107|NCT00539188|O1|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks"
1110108|NCT00539188|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks"
1110109|NCT00539188|O1|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks"
1110110|NCT00539188|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks"
1110111|NCT00539188|O1|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks"
1110112|NCT00539188|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks"
1110113|NCT00539188|O1|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks"
1110114|NCT00539188|E2|Reported Event|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks"
1110115|NCT00539188|E1|Reported Event|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks"
1110116|NCT00539110|B3|Baseline|Total|Total of all reporting groups
1110119|NCT00539110|P2|Participant Flow|Ramelteon, Then Zolpidem|"medication dosed at 2200 and 0200 per the feeding tube~washout with no sleep meds (x3 nights); ramelteon (x4 nights); washout (x3 nights); then zolpidem (x 4 nights)"
1110120|NCT00539110|P1|Participant Flow|Zolpidem First, Then Ramelteon|"medication dosed at 2200 and 0200 per feeding tube~washout with no sleep meds (3 nights); zolpidem (x4 nights); washout (x3 nights); then ramelteon (x4 nights)"
1110121|NCT00539110|O2|Outcome|Ramelteon|dosed at 2200 and 0200 per the feeding tube
1110122|NCT00539110|O1|Outcome|Zolpidem|medication dosed at 2200 and 0200 per feeding tube
1110123|NCT00539110|E2|Reported Event|Ramelteon|"dosed at 2200 and 0200 per the feeding tube~ramelteon: medication dosed at 2200 and 0200 per feeding tube"
1110124|NCT00539110|E1|Reported Event|Zolpidem|"medication dosed at 2200 and 0200 per feeding tube~zolipidem: dosed at 2200 and 0200 per feeding tube"
1110125|NCT00539032|B3|Baseline|Total|Total of all reporting groups
1110126|NCT00539032|B2|Baseline|Group 2: Menactra® Primary Vaccine (Control) Group|Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
1110127|NCT00539032|B1|Baseline|Group 1: Menactra® Booster Group|Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
1110128|NCT00539032|P2|Participant Flow|Group 2: Menactra® Primary Vaccine (Control) Group|Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
1110129|NCT00539032|P1|Participant Flow|Group 1: Menactra® Booster Group|Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
1110130|NCT00539032|O2|Outcome|Group 2: Menactra® Primary Vaccine (Control) Group|Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
1110131|NCT00539032|O1|Outcome|Group 1: Menactra® Booster Group|Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
1110132|NCT00539032|O2|Outcome|Group 2: Menactra® Primary Vaccine (Control) Group|Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
1110133|NCT00539032|O1|Outcome|Group 1: Menactra® Booster Group|Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
1110592|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
1110134|NCT00539032|O2|Outcome|Group 2: Menactra® Primary Vaccine (Control) Group|Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
1110135|NCT00539032|O1|Outcome|Group 1: Menactra® Booster Group|Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
1110136|NCT00539032|E2|Reported Event|Group 2: Menactra® Primary Vaccine (Control) Group|Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
1110137|NCT00539032|E1|Reported Event|Group 1: Menactra® Booster Group|Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
1110138|NCT00539006|B5|Baseline|Total|Total of all reporting groups
1110139|NCT00539006|B4|Baseline|Placebo - FP/FF|Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
1110140|NCT00539006|B3|Baseline|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
1110141|NCT00539006|B2|Baseline|Placebo - FF/FP|Participants who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
1110142|NCT00539006|B1|Baseline|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray (FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
1110143|NCT00539006|P4|Participant Flow|Placebo - FP/FF|Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
1110144|NCT00539006|P3|Participant Flow|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
1110145|NCT00539006|P2|Participant Flow|Placebo - FF/FP|Participants who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
1110146|NCT00539006|P1|Participant Flow|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray (FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
1110147|NCT00539006|O4|Outcome|Placebo - FP/FF|Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
1110148|NCT00539006|O3|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS) 110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
1110149|NCT00539006|O2|Outcome|Placebo - FF/FP|Participants who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
1111040|NCT00537095|O1|Outcome|ZD6474|ZD6474, Vandetanib 300mg
1110150|NCT00539006|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray(FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
1110151|NCT00539006|O4|Outcome|Placebo - FP/FF|Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
1110152|NCT00539006|O3|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS) 110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
1110153|NCT00539006|O2|Outcome|Placebo - FF/FP|Participants who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
1110154|NCT00539006|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray(FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
1110155|NCT00539006|O3|Outcome|Total|All participants on both arms preference.
1110156|NCT00539006|O2|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS) 110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
1110157|NCT00539006|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray(FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
1110158|NCT00539006|O3|Outcome|Total|All participants on both arms preference.
1110159|NCT00539006|O2|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS) 110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
1110194|NCT00538902|O1|Outcome|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
1110195|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
1110160|NCT00539006|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray (FFNS)110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
1110161|NCT00539006|O4|Outcome|Placebo - FP/FF|Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
1110162|NCT00539006|O3|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
1110163|NCT00539006|O2|Outcome|Placebo - FF/FP|Participants who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
1110164|NCT00539006|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray (FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
1110165|NCT00539006|O3|Outcome|Total|All participants on both arms preference.
1110166|NCT00539006|O2|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS) 110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
1110167|NCT00539006|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray(FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
1110168|NCT00539006|O3|Outcome|Total|All participants on both arms preference.
1110169|NCT00539006|O2|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS) 110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
1110170|NCT00539006|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray(FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
1110171|NCT00539006|E4|Reported Event|Placebo - FP|Subjects who took no active drug but believed they were on Fluticasone Propionate Nasal Spray.
1110172|NCT00539006|E3|Reported Event|Placebo - FF|Subjects who took no active drug but believed they were on Fluticasone Furoate Nasal Spray.
1110173|NCT00539006|E2|Reported Event|Fluticason Propionate Nasal Spray|Subjects who receive Fluticasone Propionate Nasal Spray.
1110174|NCT00539006|E1|Reported Event|Fluticasone Furoate Nasal Spray|Subjects who received Fluticasone Furoate.
1110175|NCT00538915|B1|Baseline|Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval|Each subject received a total Nabi-IGIV 10% [Immune Globulin Intravenous (Human), 10%] infusion of 300-800 mg/kg per month administered intravenously every 3 or 4 weeks for approximately 1 year.
1110176|NCT00538915|P1|Participant Flow|Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval|Each subject received a total Nabi-IGIV 10% [Immune Globulin Intravenous (Human), 10%] infusion of 300-800 mg/kg per month administered intravenously every 3 or 4 weeks for approximately 1 year.
1110313|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110177|NCT00538915|O1|Outcome|Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval|Each subject received a total Nabi-IGIV 10% [Immune Globulin Intravenous (Human), 10%] infusion of 300-800 mg/kg administered intravenously every 3 or 4 weeks for approximately 1 year.
1110178|NCT00538915|E1|Reported Event|Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval|Each subject received a total Nabi-IGIV 10% [Immune Globulin Intravenous (Human), 10%] infusion of 300-800 mg/kg per month administered intravenously every 3 or 4 weeks for approximately 1 year.
1110179|NCT00538902|B4|Baseline|Total|Total of all reporting groups
1110180|NCT00538902|B3|Baseline|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
1110181|NCT00538902|B2|Baseline|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
1110182|NCT00538902|B1|Baseline|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
1110183|NCT00538902|P3|Participant Flow|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 12 weeks.
1110184|NCT00538902|P2|Participant Flow|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 24 weeks.
1110185|NCT00538902|P1|Participant Flow|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 12 weeks.
1110186|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
1110187|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
1110188|NCT00538902|O3|Outcome|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
1110189|NCT00538902|O2|Outcome|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
1110190|NCT00538902|O1|Outcome|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
1110191|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
1110192|NCT00538902|O3|Outcome|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
1110196|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
1110197|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
1110198|NCT00538902|O3|Outcome|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
1110199|NCT00538902|O2|Outcome|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
1110200|NCT00538902|O1|Outcome|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
1110201|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
1110202|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
1110203|NCT00538902|O3|Outcome|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
1110204|NCT00538902|O2|Outcome|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
1110205|NCT00538902|O1|Outcome|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
1110206|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
1110207|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
1110208|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
1110209|NCT00538902|O3|Outcome|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
1110210|NCT00538902|O2|Outcome|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
1110211|NCT00538902|O1|Outcome|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
1110212|NCT00538902|O3|Outcome|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
1110213|NCT00538902|O2|Outcome|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
1110214|NCT00538902|O1|Outcome|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
1110215|NCT00538902|E4|Reported Event|Any Adalimumab|Any adalimumab exposure during the entire study, whether from Double-Blind or Open-Label treatment.
1110216|NCT00538902|E3|Reported Event|DB Phase - Adalimumab 80 mg EOW|Adalimumab 80 mg administered subcutaneously every other week during Double-Blind treatment.
1110217|NCT00538902|E2|Reported Event|DB Phase - Adalimumab 40 mg EOW|Adalimumab 40 mg administered subcutaneously every other week during Double-Blind treatment.
1110218|NCT00538902|E1|Reported Event|DB Phase - Placebo EOW|Placebo administered subcutaneously every other week during Double-Blind treatment.
1110314|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110676|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
1110219|NCT00538863|B1|Baseline|Fentanyl Sublingual Spray|In the titration period, patients were titrated upward to a maximum dose of 1600 µg fentanyl sublingual spray. In the maintenance period, patients received a dose of 100 to 1600 µg fentanyl sublingual spray determined in a previous study (INS-05-001, NCT00538850) or in the titration period of the current study.
1110220|NCT00538863|P1|Participant Flow|Fentanyl Sublingual Spray|In the titration period, patients were titrated upward to a maximum dose of 1600 µg fentanyl sublingual spray. In the maintenance period, patients received a dose of 100 to 1600 µg fentanyl sublingual spray determined in a previous study (INS-05-001, NCT00538850) or in the titration period of the current study.
1110221|NCT00538863|O2|Outcome|Fentanyl Sublingual Spray Maintenance|Patients received fentanyl sublingual spray up to a maximum of 4 times per day with a minimum separation of 4 hours between treatments for 90 days. Patients received a dose of 100 to 1600 µg determined in a previous study (INS-05-001, NCT00538850) or in the open-label dose titration period of the current study. The dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects.
1110222|NCT00538863|O1|Outcome|Fentanyl Sublingual Spray Titration|Patients received fentanyl sublingual spray to treat up to a maximum of 4 breakthrough pain episodes per day with a minimum separation of 4 hours between treatments. Patients started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 26 days was reached.
1110223|NCT00538863|E2|Reported Event|Fentanyl Sublingual Spray Maintenance|Patients received fentanyl sublingual spray up to a maximum of 4 times per day with a minimum separation of 4 hours between treatments for 90 days. Patients received a dose of 100 to 1600 µg determined in a previous study (INS-05-001, NCT00538850) or in the open-label dose titration period of the current study. The dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects.
1110224|NCT00538863|E1|Reported Event|Fentanyl Sublingual Spray Titration|Patients received fentanyl sublingual spray to treat up to a maximum of 4 breakthrough pain episodes per day with a minimum separation of 4 hours between treatments. Patients started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 26 days was reached.
1110225|NCT00538850|B1|Baseline|Fentanyl Sublingual Spray|Participants received fentanyl sublingual spray 7 times or placebo 3 times in random order to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
1110274|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
1110275|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
1110226|NCT00538850|P3|Participant Flow|Placebo - Double-blind|Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
1110227|NCT00538850|P2|Participant Flow|Fentanyl Sublingual Spray - Double-blind|Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
1110228|NCT00538850|P1|Participant Flow|Fentanyl Sublingual Spray - Titration|In the open-label titration period of the study, participants started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 21±5 days was reached.
1110229|NCT00538850|O2|Outcome|Placebo|Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
1110230|NCT00538850|O1|Outcome|Fentanyl Sublingual Spray|Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
1110231|NCT00538850|O2|Outcome|Placebo|Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
1110232|NCT00538850|O1|Outcome|Fentanyl Sublingual Spray|Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
1110233|NCT00538850|O2|Outcome|Placebo|Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
1110234|NCT00538850|O1|Outcome|Fentanyl Sublingual Spray|Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
1110235|NCT00538850|O2|Outcome|Placebo|Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
1110236|NCT00538850|O1|Outcome|Fentanyl Sublingual Spray|Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
1110315|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110237|NCT00538850|E2|Reported Event|Fentanyl Sublingual Spray - Double-blind|Participants received fentanyl sublingual spray 7 times or placebo 3 times in random order to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
1110238|NCT00538850|E1|Reported Event|Fentanyl Sublingual Spray - Titration|In the open-label titration period of the study, participants started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 21±5 days was reached.
1110239|NCT00538824|B1|Baseline|DexTR (All Patients)|"All patients were treated with the DexTR (dexamethasone / thalidomide, lenalidomide (Revlimid®)), which consisted of lenalidomide 25mg/day during days 1-21, dexamethasone 40mg/day on days 1-4, 9-12, and 17-20, and thalidomide 50mg/day for the first 7 days, followed by 100mg/day for all subsequent days, for a total of 4 cycles of 28 days each.~dexamethasone: Cycles 1-4~• Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle.~After completing 4 cycles:~Patients who demonstrate disease progression at any time will be taken off study.~Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for > 2 cycles will be transitioned to maintenance therapy.~Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for >2 cycles or CR in the absence of unt"
1110240|NCT00538824|P1|Participant Flow|DexTR (All Patients)|"All patients were treated with the DexTR (dexamethasone / thalidomide, lenalidomide (Revlimid®)), which consisted of lenalidomide 25mg/day during days 1-21, dexamethasone 40mg/day on days 1-4, 9-12, and 17-20, and thalidomide 50mg/day for the first 7 days, followed by 100mg/day for all subsequent days, for a total of 4 cycles of 28 days each.~dexamethasone: Cycles 1-4~• Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle.~After completing 4 cycles:~Patients who demonstrate disease progression at any time will be taken off study.~Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for > 2 cycles will be transitioned to maintenance therapy.~Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for >2 cycles or CR in the absence of unt"
1110276|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
1110277|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
1114318|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
1110241|NCT00538824|O1|Outcome|DexTR (All Patients)|"All patients were treated with the DexTR (dexamethasone / thalidomide, lenalidomide (Revlimid®)), which consisted of lenalidomide 25mg/day during days 1-21, dexamethasone 40mg/day on days 1-4, 9-12, and 17-20, and thalidomide 50mg/day for the first 7 days, followed by 100mg/day for all subsequent days, for a total of 4 cycles of 28 days each.~dexamethasone: Cycles 1-4~• Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle.~After completing 4 cycles:~Patients who demonstrate disease progression at any time will be taken off study.~Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for > 2 cycles will be transitioned to maintenance therapy.~Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for >2 cycles or CR in the absence of unt"
1110242|NCT00538824|E1|Reported Event|DexTR (All Patients)|"All patients were treated with the DexTR (dexamethasone / thalidomide, lenalidomide (Revlimid®)), which consisted of lenalidomide 25mg/day during days 1-21, dexamethasone 40mg/day on days 1-4, 9-12, and 17-20, and thalidomide 50mg/day for the first 7 days, followed by 100mg/day for all subsequent days, for a total of 4 cycles of 28 days each.~dexamethasone: Cycles 1-4~• Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle.~After completing 4 cycles:~Patients who demonstrate disease progression at any time will be taken off study.~Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for > 2 cycles will be transitioned to maintenance therapy.~Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for >2 cycles or CR in the absence of unt"
1110243|NCT00538785|B3|Baseline|Total|Total of all reporting groups
1110244|NCT00538785|B2|Baseline|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
1110245|NCT00538785|B1|Baseline|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
1110246|NCT00538785|P2|Participant Flow|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
1110247|NCT00538785|P1|Participant Flow|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
1110248|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
1110316|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110317|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110249|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
1110250|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
1110251|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
1110252|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
1110253|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
1110278|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
1110279|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
1110280|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
1110254|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
1110255|NCT00538785|O2|Outcome|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
1110256|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
1110257|NCT00538785|O2|Outcome|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
1110258|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
1110259|NCT00538785|O2|Outcome|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
1110260|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
1110261|NCT00538785|O2|Outcome|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
1110262|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
1110263|NCT00538785|O2|Outcome|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
1110318|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110319|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110320|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110264|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
1110265|NCT00538785|E2|Reported Event|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
1110266|NCT00538785|E1|Reported Event|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
1110267|NCT00538642|B3|Baseline|Total|Total of all reporting groups
1110268|NCT00538642|B2|Baseline|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
1110269|NCT00538642|B1|Baseline|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
1110270|NCT00538642|P2|Participant Flow|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
1110271|NCT00538642|P1|Participant Flow|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
1110272|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
1110273|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
1114319|NCT00529542|O2|Outcome|Placebo|Placebo qd
1110281|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
1110282|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
1110283|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
1110284|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
1110285|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
1110286|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
1110287|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
1110288|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
1110289|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
1110290|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
1110291|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
1110292|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
1110293|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
1110294|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
1110295|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
1110296|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
1110297|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
1110298|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
1110299|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
1110300|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
1110301|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
1110302|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
1110303|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
1110304|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
1110305|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
1110306|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
1110307|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
1110308|NCT00538642|E2|Reported Event|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
1110309|NCT00538642|E1|Reported Event|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
1110310|NCT00538629|B1|Baseline|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110311|NCT00538629|P1|Participant Flow|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1111041|NCT00537095|O2|Outcome|PLACEBO|PLACEBO
1110322|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110323|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110324|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110325|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110326|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110327|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110328|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110329|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110330|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110331|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110332|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110333|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110334|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110335|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110336|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110337|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110338|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110339|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110340|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110341|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110342|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110343|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110584|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
1110344|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110345|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110346|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110347|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110348|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110349|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110350|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110351|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110352|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110353|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110354|NCT00538629|E1|Reported Event|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
1110355|NCT00538616|B3|Baseline|Total|Total of all reporting groups
1110356|NCT00538616|B2|Baseline|Propofol- Precedex|Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours.
1110357|NCT00538616|B1|Baseline|Precedex-Propofol|Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours.
1110358|NCT00538616|P2|Participant Flow|Propofol- Precedex|Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours.
1110359|NCT00538616|P1|Participant Flow|Precedex-Propofol|Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours.
1110360|NCT00538616|O2|Outcome|Propofol- Precedex|Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours.
1110361|NCT00538616|O1|Outcome|Precedex-Propofol|Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours.
1110362|NCT00538616|E2|Reported Event|Propofol- Precedex|Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours.
1110363|NCT00538616|E1|Reported Event|Precedex-Propofol|Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours.
1110364|NCT00538590|B3|Baseline|Total|Total of all reporting groups
1110365|NCT00538590|B2|Baseline|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
1110366|NCT00538590|B1|Baseline|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
1110367|NCT00538590|P2|Participant Flow|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
1110368|NCT00538590|P1|Participant Flow|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
1110369|NCT00538590|O2|Outcome|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
1110370|NCT00538590|O1|Outcome|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
1110371|NCT00538590|O2|Outcome|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
1110372|NCT00538590|O1|Outcome|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
1110373|NCT00538590|O2|Outcome|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
1110374|NCT00538590|O1|Outcome|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
1110375|NCT00538590|O2|Outcome|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
1110376|NCT00538590|O1|Outcome|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
1110377|NCT00538590|O2|Outcome|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
1110378|NCT00538590|O1|Outcome|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
1110379|NCT00538590|E2|Reported Event|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
1110380|NCT00538590|E1|Reported Event|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
1110381|NCT00538512|B4|Baseline|Total|Total of all reporting groups
1110382|NCT00538512|B3|Baseline|Placebo|Physiologic saline administered as a nasal spray or intramuscular injection
1110383|NCT00538512|B2|Baseline|Flumist - Live-attenuated Influenza Vaccine|live-attenuated influenza vaccine Flumist, manufactured by MedImmune
1110384|NCT00538512|B1|Baseline|Fluzone - Trivalent Inactivated Influenza Vaccine|the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
1110385|NCT00538512|P3|Participant Flow|Placebo|Physiologic saline administered as a nasal spray or intramuscular injection
1110386|NCT00538512|P2|Participant Flow|Flumist - Live-attenuated Influenza Vaccine|live-attenuated influenza vaccine Flumist, manufactured by MedImmune
1110387|NCT00538512|P1|Participant Flow|Fluzone - Trivalent Inactivated Influenza Vaccine|the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
1110388|NCT00538512|O3|Outcome|Placebo|Physiologic saline administered as a nasal spray or intramuscular injection
1110389|NCT00538512|O2|Outcome|Flumist - Live-attenuated Influenza Vaccine|live-attenuated influenza vaccine Flumist, manufactured by MedImmune
1110390|NCT00538512|O1|Outcome|Fluzone - Trivalent Inactivated Influenza Vaccine|the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
1110391|NCT00538512|E3|Reported Event|Placebo|Physiologic saline administered as a nasal spray or intramuscular injection
1110392|NCT00538512|E2|Reported Event|Flumist - Live-attenuated Influenza Vaccine|live-attenuated influenza vaccine Flumist, manufactured by MedImmune
1110393|NCT00538512|E1|Reported Event|Fluzone - Trivalent Inactivated Influenza Vaccine|the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
1110394|NCT00538473|B3|Baseline|Total|Total of all reporting groups
1110395|NCT00538473|B2|Baseline|Fluarix Group|Subjects received 1 dose of Fluarix™.
1110396|NCT00538473|B1|Baseline|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
1110397|NCT00538473|P2|Participant Flow|Fluarix Group|Subjects received 1 dose of Fluarix™.
1110398|NCT00538473|P1|Participant Flow|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
1110399|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
1110400|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
1110401|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
1110402|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
1110403|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
1110404|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
1110405|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
1110406|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
1110407|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
1110408|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
1110409|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
1110410|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
1110411|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
1110412|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
1110413|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
1110414|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
1110415|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
1110416|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
1110417|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
1110418|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
1110419|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
1110420|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
1110421|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
1110422|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
1110423|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
1110424|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
1110425|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
1110426|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
1110427|NCT00538473|E2|Reported Event|Fluarix Group|Subjects received 1 dose of Fluarix™.
1110428|NCT00538473|E1|Reported Event|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
1110429|NCT00538434|B5|Baseline|Total|Total of all reporting groups
1110430|NCT00538434|B4|Baseline|Placebo|saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
1110431|NCT00538434|B3|Baseline|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
1110432|NCT00538434|B2|Baseline|Reslizumab 2 mg/kg|reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
1110433|NCT00538434|B1|Baseline|Reslizumab 1 mg/kg|reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
1110434|NCT00538434|P4|Participant Flow|Placebo|saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
1110435|NCT00538434|P3|Participant Flow|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
1110436|NCT00538434|P2|Participant Flow|Reslizumab 2 mg/kg|reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
1110437|NCT00538434|P1|Participant Flow|Reslizumab 1 mg/kg|reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
1110438|NCT00538434|O4|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
1110439|NCT00538434|O3|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
1110440|NCT00538434|O2|Outcome|Reslizumab 2 mg/kg|reslizumab 2 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
1110441|NCT00538434|O1|Outcome|Reslizumab 1 mg/kg|reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
1110442|NCT00538434|O4|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
1114320|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
1110443|NCT00538434|O3|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
1110444|NCT00538434|O2|Outcome|Reslizumab 2 mg/kg|reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
1110445|NCT00538434|O1|Outcome|Reslizumab 1 mg/kg|reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
1110446|NCT00538434|O4|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
1110447|NCT00538434|O3|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
1110448|NCT00538434|O2|Outcome|Reslizumab 2 mg/kg|reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
1110449|NCT00538434|O1|Outcome|Reslizumab 1 mg/kg|reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
1110450|NCT00538434|O4|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
1110451|NCT00538434|O3|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
1110452|NCT00538434|O2|Outcome|Reslizumab 2 mg/kg|reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
1110453|NCT00538434|O1|Outcome|Reslizumab 1 mg/kg|reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
1110454|NCT00538434|E4|Reported Event|Placebo|saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
1110455|NCT00538434|E3|Reported Event|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
1110456|NCT00538434|E2|Reported Event|Reslizumab 2 mg/kg|reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
1110457|NCT00538434|E1|Reported Event|Reslizumab 1 mg/kg|reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
1110458|NCT00538304|B3|Baseline|Total|Total of all reporting groups
1110459|NCT00538304|B2|Baseline|Placebo|Placebo
1110460|NCT00538304|B1|Baseline|Bimatoprost Eye Drops|Bimatoprost eye drops
1110461|NCT00538304|P2|Participant Flow|Placebo|Placebo
1110462|NCT00538304|P1|Participant Flow|Bimatoprost Eye Drops|Bimatoprost eye drops
1110463|NCT00538304|O2|Outcome|Placebo|Placebo
1110464|NCT00538304|O1|Outcome|Bimatoprost Eye Drops|Bimatoprost eye drops
1110465|NCT00538304|O2|Outcome|Placebo|Placebo
1110466|NCT00538304|O1|Outcome|Bimatoprost Eye Drops|Bimatoprost eye drops
1110467|NCT00538304|O2|Outcome|Placebo|Placebo
1110468|NCT00538304|O1|Outcome|Bimatoprost Eye Drops|Bimatoprost eye drops
1110469|NCT00538304|O2|Outcome|Placebo|Placebo
1110470|NCT00538304|O1|Outcome|Bimatoprost Eye Drops|Bimatoprost eye drops
1110471|NCT00538304|O2|Outcome|Placebo|Placebo
1110472|NCT00538304|O1|Outcome|Bimatoprost Eye Drops|Bimatoprost eye drops
1110473|NCT00538304|O2|Outcome|Placebo|Placebo
1110474|NCT00538304|O1|Outcome|Bimatoprost Eye Drops|Bimatoprost eye drops
1110475|NCT00538304|E2|Reported Event|Placebo|Placebo
1110476|NCT00538304|E1|Reported Event|Bimatoprost Eye Drops|Bimatoprost eye drops
1110477|NCT00538291|B1|Baseline|Arm 1|Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
1110478|NCT00538291|P1|Participant Flow|Arm 1|Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
1110747|NCT00537771|E1|Reported Event|Arimidex Group|Anastrozole(ARIMIDEX): 1 mg once daily oral dose
1110479|NCT00538291|O1|Outcome|Arm 1|Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
1110480|NCT00538291|E1|Reported Event|Arm 1|Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
1110481|NCT00538213|B4|Baseline|Total|Total of all reporting groups
1110482|NCT00538213|B3|Baseline|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1110483|NCT00538213|B2|Baseline|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1110484|NCT00538213|B1|Baseline|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
1110485|NCT00538213|P3|Participant Flow|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1110486|NCT00538213|P2|Participant Flow|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1110487|NCT00538213|P1|Participant Flow|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
1110488|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1110489|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1110490|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
1110491|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1110585|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
1110492|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1110493|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
1110494|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1110495|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1110496|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
1110497|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1110498|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1110499|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
1110500|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1110501|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1110502|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
1110503|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1110504|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1110505|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
1110506|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1110507|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1110508|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
1110509|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1111042|NCT00537095|O1|Outcome|ZD6474|ZD6474, Vandetanib 300mg
1110510|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1110511|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
1110512|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1110513|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1110514|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
1110515|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1110516|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1110517|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
1110518|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1110519|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1110520|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
1110521|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1110522|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1110523|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
1110524|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1110525|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1110526|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
1110527|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1110528|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1110529|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A in this study.
1110530|NCT00538213|E3|Reported Event|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1110531|NCT00538213|E2|Reported Event|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
1110532|NCT00538213|E1|Reported Event|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
1110533|NCT00537979|B3|Baseline|Total|Total of all reporting groups
1110534|NCT00537979|B2|Baseline|Paricalcitol Capsules|Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis.
1110535|NCT00537979|B1|Baseline|Paricalcitol Injection|Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis.
1110536|NCT00537979|P2|Participant Flow|Paricalcitol Capsules|Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis.
1110537|NCT00537979|P1|Participant Flow|Paricalcitol Injection|Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis.
1110538|NCT00537979|O2|Outcome|Paricalcitol Capsules|Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis.
1110539|NCT00537979|O1|Outcome|Paricalcitol Injection|Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis.
1110540|NCT00537979|O1|Outcome|Per-Protocol Population|The per-protocol population was defined as all participants who fulfilled inclusion criteria, had intact parathyroid hormone (iPTH) values greater than or equal to 300 pg/mL at baseline, and completed the study with a final iPTH determination. For this outcome measure, the group evaluated included both participants on hemodialysis receiving paricalcitol injection and those on peritoneal dialysis receiving paricalcitol capsules.
1110677|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
1111043|NCT00537095|O2|Outcome|PLACEBO|PLACEBO
1110541|NCT00537979|O1|Outcome|Per-Protocol Population|The per-protocol population was defined as all participants who fulfilled inclusion criteria, had intact parathyroid hormone (iPTH) values greater than or equal to 300 pg/mL at baseline, and completed the study with a final iPTH determination. For this outcome measure, the group evaluated included both participants on hemodialysis receiving paricalcitol injection and those on peritoneal dialysis receiving paricalcitol capsules.
1110542|NCT00537979|O2|Outcome|Paricalcitol Capsules|Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis.
1110543|NCT00537979|O1|Outcome|Paricalcitol Injection|Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis.
1110544|NCT00537979|O2|Outcome|Paricalcitol Capsules|Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis.
1110545|NCT00537979|O1|Outcome|Paricalcitol Injection|Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis.
1110546|NCT00537979|O2|Outcome|Paricalcitol Capsules|Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis.
1110547|NCT00537979|O1|Outcome|Paricalcitol Injection|Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis.
1110548|NCT00537979|E2|Reported Event|Paricalcitol Capsules|Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis.
1110549|NCT00537979|E1|Reported Event|Paricalcitol Injection|Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis.
1110550|NCT00537940|B3|Baseline|Total|Total of all reporting groups
1110551|NCT00537940|B2|Baseline|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
1110586|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
1110587|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
1110552|NCT00537940|B1|Baseline|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
1110553|NCT00537940|P2|Participant Flow|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
1110554|NCT00537940|P1|Participant Flow|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
1110555|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
1110556|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
1110678|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
1110679|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
1110557|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
1110558|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
1110559|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
1110588|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
1110560|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
1110561|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
1110562|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
1110563|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
1110564|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
1110624|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
1110565|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
1110566|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
1110567|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
1110568|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
1110569|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
1110570|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
1110571|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
1110572|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
1110625|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
1110573|NCT00537940|E2|Reported Event|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
1110574|NCT00537940|E1|Reported Event|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
1110575|NCT00536913|B3|Baseline|Total|Total of all reporting groups
1110576|NCT00536913|B2|Baseline|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
1110577|NCT00536913|B1|Baseline|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
1110578|NCT00536913|P2|Participant Flow|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
1110579|NCT00536913|P1|Participant Flow|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
1110580|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
1110581|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
1110582|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
1110583|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
1110593|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
1110594|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
1110595|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
1110596|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
1110597|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
1110598|NCT00536913|E2|Reported Event|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
1110599|NCT00536913|E1|Reported Event|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
1110600|NCT00536874|B1|Baseline|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
1110601|NCT00536874|P1|Participant Flow|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
1110602|NCT00536874|O1|Outcome|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
1110603|NCT00536874|O1|Outcome|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
1110604|NCT00536874|O1|Outcome|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
1110626|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
1110680|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
1110605|NCT00536874|O1|Outcome|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
1110606|NCT00536874|O1|Outcome|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
1110607|NCT00536874|O1|Outcome|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
1110608|NCT00536874|O1|Outcome|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
1110609|NCT00536874|E1|Reported Event|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
1110610|NCT00536809|B1|Baseline|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2/day on Days 1-14 of a 21-day cycle
1110611|NCT00536809|P1|Participant Flow|Lapatinib/Oxaliplatin/Capecitabine|Phase I: Dose escalation to a maximum tolerated dose of lapatinib 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2/day on Days 1-14 of a 21-day cycle. Phase II: Lapatinib 1000 mg/day administered orally on Days 1-21, oxaliplatin 130 mg/m^2 administered intravenously on Day 1, and capecitabine 1500 mg/m^2/day on Days 1-14 of a 21-day cycle.
1110644|NCT00536731|P3|Participant Flow|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
1110645|NCT00536731|P2|Participant Flow|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
1110612|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
1110613|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
1110614|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
1110615|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
1110616|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
1110617|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
1110618|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
1110619|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
1110620|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
1110621|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
1110622|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
1110623|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
1110627|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
1110628|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
1110629|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
1110630|NCT00536809|E1|Reported Event|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
1110631|NCT00536744|B3|Baseline|Total|Total of all reporting groups
1110632|NCT00536744|B2|Baseline|Non-energized (Inactive) Application + Standard of Care|Sham: Sham treatment (non-energized, inactive device) + Standard of care wound dressing.
1110633|NCT00536744|B1|Baseline|dermaPACE Application + Standard of Care|dermaPACE: dermaPACE + Standard of care wound dressing.
1110634|NCT00536744|P2|Participant Flow|Non-energized (Inactive) Application + Standard of Care|"Non-energized (inactive) application + standard of care~Sham: Sham treatment + Standard of care wound dressing."
1110635|NCT00536744|P1|Participant Flow|dermaPACE Application + Standard of Care|"dermaPACE application + standard of care~dermaPACE: dermaPACE + Standard of care wound dressing."
1110636|NCT00536744|O2|Outcome|Non-energized (Inactive) Application + Standard of Care|"Non-energized (inactive) application + standard of care~Sham: Sham treatment + Standard of care wound dressing."
1110637|NCT00536744|O1|Outcome|dermaPACE Application + Standard of Care|"dermaPACE application + standard of care~dermaPACE: dermaPACE + Standard of care wound dressing."
1110638|NCT00536744|E2|Reported Event|Non-energized (Inactive) Application + Standard of Care|"Non-energized (inactive) application + standard of care~Sham: Sham treatment + Standard of care wound dressing."
1110639|NCT00536744|E1|Reported Event|dermaPACE Application + Standard of Care|"dermaPACE application + standard of care~dermaPACE: dermaPACE + Standard of care wound dressing."
1110640|NCT00536731|B4|Baseline|Total|Total of all reporting groups
1110641|NCT00536731|B3|Baseline|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
1110642|NCT00536731|B2|Baseline|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
1110643|NCT00536731|B1|Baseline|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
1110646|NCT00536731|P1|Participant Flow|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
1110647|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
1110648|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
1110649|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
1110650|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
1110651|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
1110652|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
1110653|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
1110654|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
1110655|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
1110656|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
1110657|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
1110658|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
1110659|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
1110660|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
1110661|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
1110662|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
1110663|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
1110664|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
1110665|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
1110666|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
1110667|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
1110668|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
1110669|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
1110670|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
1110671|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
1110672|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
1110673|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
1110674|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
1110675|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
1110681|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
1110682|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
1110683|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
1110684|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
1110685|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
1110686|NCT00536731|E3|Reported Event|Pulmicort Turbuhaler|Pulmicort Turbuhaler
1110687|NCT00536731|E2|Reported Event|Symbicort Turbuhaler|Symbicort Turbuhaler
1110688|NCT00536731|E1|Reported Event|Symbicort pMDI|Symbicort pMDI
1110689|NCT00537823|B3|Baseline|Total|Total of all reporting groups
1110690|NCT00537823|B2|Baseline|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2~Week 7~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2~Week 7, 15~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2"
1110691|NCT00537823|B1|Baseline|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m2 IV weekly"
1110692|NCT00537823|P2|Participant Flow|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2~Week 7~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2~Week 7, 15~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2"
1110693|NCT00537823|P1|Participant Flow|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m2 IV weekly"
1110694|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2"
1110695|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m^2 IV weekly"
1110696|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2"
1110697|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m^2 IV weekly"
1110698|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2"
1110738|NCT00537771|P2|Participant Flow|TAM Group|Tamoxifen : 20 mg once daily oral dose
1110739|NCT00537771|P1|Participant Flow|Arimidex Group|Anastrozole(ARIMIDEX): 1 mg once daily oral dose
1110740|NCT00537771|O2|Outcome|TAM Group|Tamoxifen : 20 mg once daily oral dose
1111044|NCT00537095|O1|Outcome|ZD6474|ZD6474, Vandetanib 300mg
1110699|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m^2 IV weekly"
1110700|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2"
1110701|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m^2 IV weekly"
1110702|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2"
1110703|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m^2 IV weekly"
1110714|NCT00537810|B5|Baseline|Total|Total of all reporting groups
1111437|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
1110704|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2"
1110705|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m^2 IV weekly"
1110706|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2"
1110707|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m^2 IV weekly"
1110708|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2"
1110741|NCT00537771|O1|Outcome|Arimidex Group|Anastrozole(ARIMIDEX): 1 mg once daily oral dose
1110742|NCT00537771|O2|Outcome|TAM Group|Tamoxifen : 20 mg once daily oral dose
1110743|NCT00537771|O1|Outcome|Arimidex Group|Anastrozole(ARIMIDEX): 1 mg once daily oral dose
1110744|NCT00537771|O2|Outcome|TAM Group|Tamoxifen : 20 mg once daily oral dose
1110745|NCT00537771|O1|Outcome|Arimidex Group|Anastrozole(ARIMIDEX): 1 mg once daily oral dose
1110746|NCT00537771|E2|Reported Event|TAM Group|Tamoxifen : 20 mg once daily oral dose
1110709|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m^2 IV weekly"
1110710|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2"
1110711|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m^2 IV weekly"
1110712|NCT00537823|E2|Reported Event|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2"
1110713|NCT00537823|E1|Reported Event|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m^2 IV weekly"
1110715|NCT00537810|B4|Baseline|Sibutramine/CBTsh|"Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating~Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily"
1110716|NCT00537810|B3|Baseline|Placebo/CBTsh|"Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating~Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily"
1110717|NCT00537810|B2|Baseline|Placebo|"Placebo Daily~Placebo: Daily"
1110718|NCT00537810|B1|Baseline|Sibutramine|"Sibutramine 15 mg daily~Sibutramine: 15 mg daily"
1110719|NCT00537810|P4|Participant Flow|Sibutramine/CBTsh|"Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating~Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily"
1110720|NCT00537810|P3|Participant Flow|Placebo/CBTsh|"Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating~Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily"
1110721|NCT00537810|P2|Participant Flow|Placebo|"Placebo Daily~Placebo: Daily"
1110722|NCT00537810|P1|Participant Flow|Sibutramine|"Sibutramine 15 mg daily~Sibutramine: 15 mg daily"
1110723|NCT00537810|O4|Outcome|Sibutramine/CBTsh|"Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating~Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily"
1110724|NCT00537810|O3|Outcome|Placebo/CBTsh|"Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating~Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily"
1110725|NCT00537810|O2|Outcome|Placebo|"Placebo Daily~Placebo: Daily"
1110726|NCT00537810|O1|Outcome|Sibutramine|"Sibutramine 15 mg daily~Sibutramine: 15 mg daily"
1110727|NCT00537810|O4|Outcome|Sibutramine/CBTsh|"Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating~Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily"
1110728|NCT00537810|O3|Outcome|Placebo/CBTsh|"Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating~Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily"
1110729|NCT00537810|O2|Outcome|Placebo|"Placebo Daily~Placebo: Daily"
1110730|NCT00537810|O1|Outcome|Sibutramine|"Sibutramine 15 mg daily~Sibutramine: 15 mg daily"
1110731|NCT00537810|E4|Reported Event|Sibutramine/CBTsh|"Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating~Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily"
1110732|NCT00537810|E3|Reported Event|Placebo/CBTsh|"Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating~Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily"
1110733|NCT00537810|E2|Reported Event|Placebo|"Placebo Daily~Placebo: Daily"
1110734|NCT00537810|E1|Reported Event|Sibutramine|"Sibutramine 15 mg daily~Sibutramine: 15 mg daily"
1110735|NCT00537771|B3|Baseline|Total|Total of all reporting groups
1110736|NCT00537771|B2|Baseline|TAM Group|Tamoxifen : 20 mg once daily oral dose
1110737|NCT00537771|B1|Baseline|Arimidex Group|Anastrozole(ARIMIDEX): 1 mg once daily oral dose
1110748|NCT00537745|B1|Baseline|Vivitrol|Vivitrol 380 mg/monthly, plus individual compliance enhancement therapy (Medication Management Therapy).
1110749|NCT00537745|P1|Participant Flow|Vivitrol|Vivitrol 380 mg/monthly, plus individual compliance enhancement therapy (Medication Management Therapy).
1110750|NCT00537745|O1|Outcome|Vivitrol|Vivitrol 380 mg/monthly, plus individual compliance enhancement therapy (Medication Management Therapy).
1110751|NCT00537745|O1|Outcome|Participants|Intervention Group
1110752|NCT00537745|E1|Reported Event|Vivitrol|Vivitrol 380 mg/monthly, plus individual compliance enhancement therapy (Medication Management Therapy).
1110753|NCT00537680|B4|Baseline|Total|Total of all reporting groups
1110754|NCT00537680|B3|Baseline|Placebo|Placebo was provided as film-coated tablets that were the same size, weight and appearance as the idebenone tablets.
1110755|NCT00537680|B2|Baseline|High Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 1350 mg/day (2 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 2250 mg/day (2 x 150 mg tablet, t.i.d.)
1110756|NCT00537680|B1|Baseline|Mid Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 450 mg/day (1 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 900 mg/day (2 x 150 mg tablet, t.i.d.)
1110757|NCT00537680|P3|Participant Flow|Placebo|Placebo was provided as film-coated tablets that were the same size, weight and appearance as the idebenone tablets.
1110758|NCT00537680|P2|Participant Flow|High Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 1350 mg/day (2 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 2250 mg/day (2 x 150 mg tablet, t.i.d.)
1110759|NCT00537680|P1|Participant Flow|Mid Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 450 mg/day (1 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 900 mg/day (2 x 150 mg tablet, t.i.d.)
1110760|NCT00537680|O3|Outcome|Placebo|Placebo was provided as film-coated tablets that were the same size, weight and appearance as the idebenone tablets.
1110761|NCT00537680|O2|Outcome|High Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 1350 mg/day (2 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 2250 mg/day (2 x 150 mg tablet, t.i.d.)
1110762|NCT00537680|O1|Outcome|Mid Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 450 mg/day (1 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 900 mg/day (2 x 150 mg tablet, t.i.d.)
1110763|NCT00537680|E3|Reported Event|Placebo|Placebo was provided as film-coated tablets that were the same size, weight and appearance as the idebenone tablets.
1110764|NCT00537680|E2|Reported Event|High Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 1350 mg/day (2 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 2250 mg/day (2 x 150 mg tablet, t.i.d.)
1110765|NCT00537680|E1|Reported Event|Mid Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 450 mg/day (1 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 900 mg/day (2 x 150 mg tablet, t.i.d.)
1110782|NCT00537511|O3|Outcome|Pomalidomide 4 mg|Oral pomalidomide 4 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
1114321|NCT00529542|O2|Outcome|Placebo|Placebo qd
1110766|NCT00537511|B1|Baseline|Pomalidomide (Overall)|Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
1110767|NCT00537511|P1|Participant Flow|Pomalidomide (Overall)|Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
1110768|NCT00537511|O1|Outcome|Pomalidomide (Overall)|Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
1110769|NCT00537511|O5|Outcome|Pomalidomide (Overall, MTD Phase)|Participants received daily oral pomalidomide 1 mg to 5 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
1110770|NCT00537511|O4|Outcome|Pomalidomide 5 mg|Participants received daily oral pomalidomide 5 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
1110771|NCT00537511|O3|Outcome|Pomalidomide 4 mg|Participants received daily oral pomalidomide 4 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
1110772|NCT00537511|O2|Outcome|Pomalidomide 3 mg|Participants received daily oral pomalidomide 3 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
1110773|NCT00537511|O1|Outcome|Pomalidomide 1 mg|Participants received daily oral pomalidomide 1 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
1110797|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
1110798|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
1110799|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
1110800|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
1110774|NCT00537511|O1|Outcome|Pomalidomide (Overall)|Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
1110775|NCT00537511|O1|Outcome|Pomalidomide (Overall)|Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
1110776|NCT00537511|O5|Outcome|Pomalidomide (Overall, MTD Phase)|Participants received daily oral pomalidomide 1 mg to 5 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
1110777|NCT00537511|O4|Outcome|Pomalidomide 5 mg|Oral pomalidomide 5 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
1110778|NCT00537511|O3|Outcome|Pomalidomide 4 mg|Oral pomalidomide 4 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
1110779|NCT00537511|O2|Outcome|Pomalidomide 3 mg|Oral pomalidomide 3 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
1110780|NCT00537511|O1|Outcome|Pomalidomide 1 mg|Oral pomalidomide 1 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
1110781|NCT00537511|O4|Outcome|Pomalidomide 5 mg|Oral pomalidomide 5 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
1110783|NCT00537511|O2|Outcome|Pomalidomide 3 mg|Oral pomalidomide 3 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
1110784|NCT00537511|O1|Outcome|Pomalidomide 1 mg|Oral pomalidomide 1 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
1110785|NCT00537511|O1|Outcome|Pomalidomide (Overall)|Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
1110786|NCT00537511|E5|Reported Event|Pomalidomide (Overall)|Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
1110787|NCT00537511|E4|Reported Event|Pomalidomide 5 mg|Oral pomalidomide 5 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
1110788|NCT00537511|E3|Reported Event|Pomalidomide 4 mg|Oral pomalidomide 4 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
1110789|NCT00537511|E2|Reported Event|Pomalidomide 3 mg|Oral pomalidomide 3 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
1110790|NCT00537511|E1|Reported Event|Pomalidomide 1 mg|Oral pomalidomide 1 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
1110791|NCT00537485|B3|Baseline|Total|Total of all reporting groups
1110792|NCT00537485|B2|Baseline|Placebo|transdermal application of placebo, 1 time per day
1110793|NCT00537485|B1|Baseline|SPM962|transdermal application of SPM962, 1 time per day
1110794|NCT00537485|P2|Participant Flow|Placebo|transdermal application of placebo, 1 time per day
1110795|NCT00537485|P1|Participant Flow|SPM962|transdermal application of SPM962, 1 time per day
1110796|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
1110801|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
1110802|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
1110803|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
1110804|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
1110805|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
1110806|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
1110807|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
1110808|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
1110809|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
1110810|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
1110811|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
1110812|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
1110813|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
1110814|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
1110815|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
1110816|NCT00537485|E2|Reported Event|Placebo|transdermal application of placebo, 1 time per day
1110817|NCT00537485|E1|Reported Event|SPM962|transdermal application of SPM962, 1 time per day
1110818|NCT00537407|B6|Baseline|Total|Total of all reporting groups
1110819|NCT00537407|B5|Baseline|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110820|NCT00537407|B4|Baseline|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110821|NCT00537407|B3|Baseline|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1111060|NCT00537082|O3|Outcome|Placebo|Administered orally once daily for 6 months
1111061|NCT00537082|O2|Outcome|FTY720 0.5 mg|Administered orally once daily for 6 months
1110822|NCT00537407|B2|Baseline|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110823|NCT00537407|B1|Baseline|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110824|NCT00537407|P5|Participant Flow|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110825|NCT00537407|P4|Participant Flow|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110826|NCT00537407|P3|Participant Flow|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110827|NCT00537407|P2|Participant Flow|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110828|NCT00537407|P1|Participant Flow|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110829|NCT00537407|O5|Outcome|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1111045|NCT00537095|E2|Reported Event|PLACEBO|PLACEBO
1110830|NCT00537407|O4|Outcome|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110831|NCT00537407|O3|Outcome|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110832|NCT00537407|O2|Outcome|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110833|NCT00537407|O1|Outcome|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110834|NCT00537407|O5|Outcome|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110835|NCT00537407|O4|Outcome|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110836|NCT00537407|O3|Outcome|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1111062|NCT00537082|O1|Outcome|FTY720 1.25 mg|Administered orally once daily for 6 months
1110837|NCT00537407|O2|Outcome|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110838|NCT00537407|O1|Outcome|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110839|NCT00537407|O5|Outcome|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110840|NCT00537407|O4|Outcome|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110841|NCT00537407|O3|Outcome|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110842|NCT00537407|O2|Outcome|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110843|NCT00537407|O1|Outcome|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110844|NCT00537407|O5|Outcome|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110928|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
1110845|NCT00537407|O4|Outcome|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110846|NCT00537407|O3|Outcome|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110847|NCT00537407|O2|Outcome|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110848|NCT00537407|O1|Outcome|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110849|NCT00537407|O5|Outcome|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110850|NCT00537407|O4|Outcome|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110851|NCT00537407|O3|Outcome|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110852|NCT00537407|O2|Outcome|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110853|NCT00537407|O1|Outcome|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110854|NCT00537407|O2|Outcome|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110855|NCT00537407|O1|Outcome|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110856|NCT00537407|O3|Outcome|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110857|NCT00537407|O2|Outcome|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110858|NCT00537407|O1|Outcome|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110859|NCT00537407|E5|Reported Event|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1111046|NCT00537095|E1|Reported Event|ZD6474|ZD6474, Vandetanib 300mg
1111047|NCT00537082|B4|Baseline|Total|Total of all reporting groups
1110860|NCT00537407|E4|Reported Event|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110861|NCT00537407|E3|Reported Event|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110862|NCT00537407|E2|Reported Event|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110863|NCT00537407|E1|Reported Event|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
1110864|NCT00537394|B4|Baseline|Total|Total of all reporting groups
1110865|NCT00537394|B3|Baseline|Non-randomized Group: Add NRTIs to Individual Regimen cPSS <=2|Among persons whose ARV resistance and history profile precluded any of the 20 possible ARV regimens having high enough potential potency (cPSS <=2), treatment was assigned rather than being a randomized. To their regimen, individualized NRTI combination of at least 2 drugs from this class were added in order to form the most potent ARV regimen possible.
1110866|NCT00537394|B2|Baseline|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
1110867|NCT00537394|B1|Baseline|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
1110868|NCT00537394|P3|Participant Flow|Non-randomized Group: Add NRTIs to Individual Regimen cPSS <=2|[Non-randomized Group C] : Among persons whose ARV resistance and history profile precluded any of the 20 possible ARV regimens having high enough potential potency (cPSS <=2), treatment was assigned rather than being a randomized. To their regimen, individualized NRTI combination of at least 2 drugs from this class were added in order to form the most potent ARV regimen possible.
1110869|NCT00537394|P2|Participant Flow|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|[Arm B] Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
1110870|NCT00537394|P1|Participant Flow|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|[Arm A]Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
1110871|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
1110872|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
1110873|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
1110874|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
1110875|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
1110876|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
1110877|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
1110878|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
1110879|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
1110880|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
1110881|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
1110882|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
1110883|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
1114322|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
1110884|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
1110885|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
1110886|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
1110887|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
1110888|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
1110889|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
1110890|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
1110891|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
1110892|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
1111048|NCT00537082|B3|Baseline|Placebo|Administered orally once daily for 6 months
1111049|NCT00537082|B2|Baseline|FTY720 0.5 mg|Administered orally once daily for 6 months
1110893|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
1110894|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
1110895|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
1110896|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
1110897|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
1110898|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
1110899|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
1110900|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
1110901|NCT00537394|E2|Reported Event|Omit NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
1110902|NCT00537394|E1|Reported Event|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
1110903|NCT00537381|B3|Baseline|Total|Total of all reporting groups
1110904|NCT00537381|B2|Baseline|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
1110905|NCT00537381|B1|Baseline|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
1110906|NCT00537381|P2|Participant Flow|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
1110907|NCT00537381|P1|Participant Flow|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
1110908|NCT00537381|O2|Outcome|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
1110909|NCT00537381|O1|Outcome|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
1111050|NCT00537082|B1|Baseline|FTY720 1.25 mg|Administered orally once daily for 6 months
1110910|NCT00537381|O2|Outcome|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
1110911|NCT00537381|O1|Outcome|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
1110912|NCT00537381|O2|Outcome|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
1110913|NCT00537381|O1|Outcome|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
1110914|NCT00537381|O2|Outcome|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
1110915|NCT00537381|O1|Outcome|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
1110916|NCT00537381|O2|Outcome|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
1111063|NCT00537082|O3|Outcome|Placebo|Administered orally once daily for 6 months
1111064|NCT00537082|O2|Outcome|FTY720 0.5 mg|Administered orally once daily for 6 months
1111065|NCT00537082|O1|Outcome|FTY720 1.25 mg|Administered orally once daily for 6 months
1110917|NCT00537381|O1|Outcome|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
1110918|NCT00537381|O2|Outcome|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
1110919|NCT00537381|O1|Outcome|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
1110920|NCT00537381|O2|Outcome|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
1110921|NCT00537381|O1|Outcome|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
1110922|NCT00537381|E4|Reported Event|Docetaxel + Prednisone + Placebo/ D+ P + Intetumumab|Participants who initially received Docetaxel + Prednisone + Placebo until disease progression were switched their treatment to Docetaxel (D) + Prednisone (P) + intetumumab (9 participants) and received intetumumab 10 mg/kg as intravenous infusion every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily till disease progression.
1110923|NCT00537381|E3|Reported Event|Docetaxel + Prednisone + Placebo/ Intetumumab|Participants who initially received Docetaxel + Prednisone + Placebo until disease progression were switched their treatment to intetumumab alone (2 participants) and received intetumumab 10 mg/kg as intravenous infusion every 3 weeks till disease progression.
1110924|NCT00537381|E2|Reported Event|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
1110925|NCT00537381|E1|Reported Event|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
1110926|NCT00537329|B1|Baseline|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
1110927|NCT00537329|P1|Participant Flow|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
1111051|NCT00537082|P3|Participant Flow|Placebo|Administered orally once daily for 6 months
1110929|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
1110930|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
1110931|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
1110932|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
1110933|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
1110934|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
1110935|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
1110936|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
1110937|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
1110938|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
1110939|NCT00537329|E1|Reported Event|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
1110940|NCT00537316|B7|Baseline|Total|Total of all reporting groups
1111066|NCT00537082|E3|Reported Event|Placebo|Administered orally once daily for 6 months
1111067|NCT00537082|E2|Reported Event|FTY720 0.5mg|Administered orally once daily for 6 months
1111068|NCT00537082|E1|Reported Event|FTY720 1.25mg|Administered orally once daily for 6 months
1114323|NCT00529542|O2|Outcome|Placebo|Placebo qd
1110941|NCT00537316|B6|Baseline|Intermittent IFX (During Part 2)|Participants enrolled directly and randomized to intermittent IFX received IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained) and placebo to AZA daily in Part 2 of the study (1 participant from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study).
1110942|NCT00537316|B5|Baseline|Intermittent IFX/AZA (During Part 2)|Participants enrolled directly and randomized to intermittent IFX/AZA received IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained) plus AZA 2.5 mg/kg of body weight daily in Part 2 of the study (3 participants from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study).
1110943|NCT00537316|B4|Baseline|Maintenance IFX/AZA (During Part 2)|Participants enrolled directly and randomized to maintenance IFX/AZA received IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry) plus AZA 2.5 mg/kg of body weight daily in Part 2 of the study (4 participants from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study).
1110944|NCT00537316|B3|Baseline|IFX/AZA|"All treated participants. IFX 5 mg/kg IV at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks.~Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; non-responders to IFX/AZA will receive placebo IFX infusions at Weeks 8 and 10 and one additional IFX infusion at Week 14."
1110945|NCT00537316|B2|Baseline|Azathioprine (AZA)|All treated participants. AZA 2.5 mg/kg orally for 16 weeks and placebo to IFX infusion at Weeks 0, 2, and 6. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14. This group included 20 participants who did not respond to AZA monotherapy at Week 8 had IFX added to their treatment regimen at Weeks 8, 10, and 14.
1110946|NCT00537316|B1|Baseline|Infliximab (IFX)|All treated participants. IFX 5 mg/kg IV infusions administered at Weeks 0, 2, and 6 and placebo to AZA daily for 16 weeks. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.
1110947|NCT00537316|P7|Participant Flow|Intermittent IFX (During Part 2)|Participants randomized to intermittent IFX received IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained) and placebo to AZA as allocated in Part 1 of the study (1 participant from Part 1 of the study and 1 participant was enrolled directly into Part 2 of the study).
1110948|NCT00537316|P6|Participant Flow|Intermittent IFX/AZA (During Part 2)|Participants randomized to intermittent IFX/AZA received IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained) plus AZA 2.5 mg/kg of body weight daily in Part 2 of the study (3 participants from Part 1 of the study and 1 participant was enrolled directly into Part 2 of the study).
1110949|NCT00537316|P5|Participant Flow|Maintenance IFX (During Part 2)|Participants randomized to maintenance IFX received infusion of IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry) and placebo to AZA therapy as allocated in Part 1 of the study (all participants were from Part 1 of the study).
1110950|NCT00537316|P4|Participant Flow|Maintenance IFX/AZA (During Part 2)|Participants randomized to maintenance IFX/AZA received IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry) plus AZA 2.5 mg/kg of body weight daily in Part 2 of the study (4 participants from Part 1 of the study and 1 participant was enrolled directly into Part 2 of the study).
1110951|NCT00537316|P3|Participant Flow|IFX/AZA|"IFX 5 mg/kg IV infusion at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks.~Responders to IFX/AZA at Week 8 will receive one more IFX infusion at Week 14; non-responders to IFX/AZA will receive placebo IFX infusions at Weeks 8 and 10 and one additional IFX infusion at Week 14."
1110972|NCT00537316|E5|Reported Event|AZA to IFX/AZA After Week 8|Participants received AZA 2.5 mg/kg orally for 16 weeks and had IV infusions of IFX 5mg/kg of body weight added to their treatment regimen at Weeks 8, 10, and 14. Participants were either non-responders to AZA at Week 8 or had worsening of disease at Week 8.
1110952|NCT00537316|P2|Participant Flow|Azathioprine (AZA)|AZA 2.5 mg/kg orally for 16 weeks and placebo to IFX infusion at Weeks 0, 2, and 6. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one placebo IFX infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive IFX at Weeks 8, 10, and 14. This group included 20 participants who did not respond to AZA monotherapy at Week 8 had IFX added to their treatment regimen at Weeks 8, 10, and 14.
1110953|NCT00537316|P1|Participant Flow|Infliximab (IFX)|IFX 5 mg/kg Intravenous (IV) infusions administered at Weeks 0, 2, and 6 and placebo to AZA (orally) daily for 16 weeks. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.
1110954|NCT00537316|O3|Outcome|IFX/AZA|"IFX 5 mg/kg IV at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks.~Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; non-responders to IFX/AZA will receive placebo infusions at Weeks 8 and 10 and one additional infliximab infusion at Week 14."
1110955|NCT00537316|O2|Outcome|Azathioprine (AZA)|AZA 2.5 mg/kg orally for 14 weeks and placebo to IFX infusion at Weeks 0, 2, and 6. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14. This group included 20 subjects who did not respond to AZA monotherapy at Week 8 had IFX added to their treatment regimen at Weeks 8, 10, and 14.
1110956|NCT00537316|O1|Outcome|Infliximab (IFX)|IFX 5 mg/kg IV infusions administered at Weeks 0, 2, and 6 and placebo to AZA daily for 16 weeks. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.
1110957|NCT00537316|O3|Outcome|IFX/AZA|"IFX 5 mg/kg IV at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks.~Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; non-responders to IFX/AZA will receive placebo infusions at Weeks 8 and 10 and one additional infliximab infusion at Week 14."
1111073|NCT00537056|O1|Outcome|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.
1110958|NCT00537316|O2|Outcome|Azathioprine (AZA)|AZA 2.5 mg/kg orally for 14 weeks and placebo to IFX infusion at Weeks 0, 2, and 6. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14. This group included 20 subjects who did not respond to AZA monotherapy at Week 8 had IFX added to their treatment regimen at Weeks 8, 10, and 14.
1110959|NCT00537316|O1|Outcome|Infliximab (IFX)|IFX 5 mg/kg IV infusions administered at Weeks 0, 2, and 6 and placebo to AZA daily for 16 weeks. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.
1110960|NCT00537316|O3|Outcome|IFX/AZA|"IFX 5 mg/kg IV at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks.~Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; non-responders to IFX/AZA will receive placebo infusions at Weeks 8 and 10 and one additional infliximab infusion at Week 14."
1110961|NCT00537316|O2|Outcome|Azathioprine (AZA)|AZA 2.5 mg/kg orally for 14 weeks and placebo to IFX infusion at Weeks 0, 2, and 6. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14. This group included 20 subjects who did not respond to AZA monotherapy at Week 8 had IFX added to their treatment regimen at Weeks 8, 10, and 14.
1110962|NCT00537316|O1|Outcome|Infliximab (IFX)|IFX 5 mg/kg IV infusions administered at Weeks 0, 2, and 6 and placebo to AZA daily for 16 weeks. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.
1110963|NCT00537316|E14|Reported Event|IFX (Part 2)|Participants received IV infusions of IFX 5 mg/kg of body weight until the end of the study. All participants were from Part 1 of the study.
1110964|NCT00537316|E13|Reported Event|IFX/AZA (Part 2)|Participants received IV infusions of IFX 5 mg/kg of body weight every 8 weeks and AZA 2.5 mg/kg of body weight orally daily until the end of the study. All participants were from Part 1 of the study.
1110965|NCT00537316|E12|Reported Event|AZA (Part 2)|Participants received AZA 2.5 mg/kg of body weight orally daily for Part 2 of the study. All participants were from Part 1 of the study.
1110966|NCT00537316|E11|Reported Event|Intermittent IFX (Part 2)|Participants randomized to intermittent IFX received IV infusions of IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained). One participant from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study.
1110967|NCT00537316|E10|Reported Event|Intermittent IFX/AZA (Part 2)|Participants randomized to intermittent IFX/AZA received IV infusions of IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained) plus AZA 2.5 mg/kg of body weight daily. Three participants were from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study.
1110968|NCT00537316|E9|Reported Event|Maintenance IFX (Part 2)|Participants randomized to maintenance IFX received IV infusions of IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry). All participants were from Part 1 of the study.
1110969|NCT00537316|E8|Reported Event|Maintenance IFX/AZA (Part 2)|Participants randomized to maintenance IFX/AZA during Part 2 received IV infusion of IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry) plus AZA 2.5 mg/kg of body weight daily. Four participants were from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study.
1110970|NCT00537316|E7|Reported Event|IFX After Week 8|Participants received IV infusions of IFX 5 mg/kg of body weight administered at Weeks 0, 2, and 6. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.
1110971|NCT00537316|E6|Reported Event|IFX/AZA After Week 8|"Participants received IV infusions of IFX 5 mg/kg of body weight at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks.~Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; nonresponders to IFX/AZA will receive placebo infusions at Weeks 8 and 10 and one additional infliximab infusion at Week 14."
1111029|NCT00537199|P1|Participant Flow|OraTest + Visual Exam|Visual oral exam, followed by OraTest Rinse Staining Procedure
1110973|NCT00537316|E4|Reported Event|AZA After Week 8|Participants received AZA 2.5 mg/kg orally daily for 16 weeks. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14.
1110974|NCT00537316|E3|Reported Event|IFX Through Week 8|Participants received IV infusions of IFX 5 mg/kg of body weight administered at Weeks 0, 2, and 6. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.
1110975|NCT00537316|E2|Reported Event|IFX/AZA Through Week 8|"Participants received intravenous (IV) infusions of IFX 5 mg/kg of body weight at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks.~Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; nonresponders to IFX/AZA will receive placebo infusions at Weeks 8 and 10 and one additional infliximab infusion at Week 14."
1110976|NCT00537316|E1|Reported Event|AZA Through Week 8|Participants received AZA 2.5 mg/kg orally daily for 16 weeks. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14.
1110977|NCT00537303|B3|Baseline|Total|Total of all reporting groups
1110978|NCT00537303|B2|Baseline|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
1110979|NCT00537303|B1|Baseline|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
1110980|NCT00537303|P2|Participant Flow|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
1110981|NCT00537303|P1|Participant Flow|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
1110982|NCT00537303|O2|Outcome|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
1110983|NCT00537303|O1|Outcome|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
1110984|NCT00537303|O2|Outcome|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
1110985|NCT00537303|O1|Outcome|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
1110986|NCT00537303|O2|Outcome|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
1110987|NCT00537303|O1|Outcome|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
1110988|NCT00537303|O2|Outcome|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
1110989|NCT00537303|O1|Outcome|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
1110990|NCT00537303|O2|Outcome|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
1111030|NCT00537199|O1|Outcome|OraTest + Visual Exam|Visual oral exam, followed by OraTest Rinse Staining Procedure
1111031|NCT00537199|E1|Reported Event|OraTest + Visual Exam|Visual oral exam, followed by OraTest Rinse Staining Procedure
1111032|NCT00537095|B3|Baseline|Total|Total of all reporting groups
1110991|NCT00537303|O1|Outcome|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
1110992|NCT00537303|O2|Outcome|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
1110993|NCT00537303|O1|Outcome|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
1110994|NCT00537303|E2|Reported Event|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
1110995|NCT00537303|E1|Reported Event|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
1111074|NCT00537056|O1|Outcome|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan followed by Sunitinib therapy at 50 mg/day.
1114324|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
1110996|NCT00537277|B1|Baseline|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
1110997|NCT00537277|P1|Participant Flow|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
1110998|NCT00537277|O1|Outcome|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
1110999|NCT00537277|O1|Outcome|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
1111000|NCT00537277|O1|Outcome|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
1111001|NCT00537277|O1|Outcome|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
1111002|NCT00537277|O1|Outcome|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
1111003|NCT00537277|O1|Outcome|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
1111004|NCT00537277|E1|Reported Event|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
1111005|NCT00537238|B3|Baseline|Total|Total of all reporting groups
1111069|NCT00537056|B1|Baseline|F-18 FDG PET/CT and DCE MRI|"FDG PET CT F-18 Fluoro-deoxi-glucose: 15 mCi iv Gadolinium-DTPA: 0.1 mmol/kg Sunitinib: 50 mg/day po~FDG PET CT: nuclear medicine imaging technique which produces a three-dimensional image or picture of functional processes in the body~DCE MRI: DCE MRI will be acquired using rapid intravenous bolus of gadolinium-DTPA (0.1 mmol/kg).~F-18 Fluoro-deoxi-glucose: 15 mCi iv~Gadolinium-DTPA: 0.1 mmol/kg iv~Sunitinib: 50 mg/day po"
1111438|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
1111006|NCT00537238|B2|Baseline|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
1111007|NCT00537238|B1|Baseline|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
1111008|NCT00537238|P2|Participant Flow|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
1111009|NCT00537238|P1|Participant Flow|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily (BID) for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the titration phase (TP). If seizure control was inadequate (adequate: at least [>=] 50% reduction in seizures), pregabalin dose was escalated to 225 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week maintenance phase(MP). Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during TP and MP. After MP, participants were allowed to progress into optional (opt) blinded continuation phase, and remained on dose from MP for a maximum of 2 years or until last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
1111010|NCT00537238|O2|Outcome|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
1111011|NCT00537238|O1|Outcome|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
1111033|NCT00537095|B2|Baseline|PLACEBO|PLACEBO
1111034|NCT00537095|B1|Baseline|ZD6474|ZD6474, Vandetanib 300mg
1111035|NCT00537095|P2|Participant Flow|PLACEBO|PLACEBO
1111036|NCT00537095|P1|Participant Flow|ZD6474|ZD6474, Vandetanib 300mg
1111012|NCT00537238|O2|Outcome|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
1111070|NCT00537056|P1|Participant Flow|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.
1111071|NCT00537056|O1|Outcome|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan followed by Sunitinib therapy at 50 mg/day.
1111072|NCT00537056|O1|Outcome|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.
1111439|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
1111013|NCT00537238|O1|Outcome|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
1111014|NCT00537238|O2|Outcome|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
1111015|NCT00537238|O1|Outcome|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
1111016|NCT00537238|O2|Outcome|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
1111017|NCT00537238|O1|Outcome|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
1111018|NCT00537238|O2|Outcome|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
1111019|NCT00537238|O1|Outcome|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
1111037|NCT00537095|O2|Outcome|PLACEBO|PLACEBO
1111038|NCT00537095|O1|Outcome|ZD6474|ZD6474, Vandetanib 300mg
1111020|NCT00537238|O2|Outcome|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
1111021|NCT00537238|O1|Outcome|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
1111022|NCT00537238|O2|Outcome|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
1111023|NCT00537238|O1|Outcome|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
1111024|NCT00537238|O2|Outcome|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
1111025|NCT00537238|O1|Outcome|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
1111026|NCT00537238|E2|Reported Event|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
1111027|NCT00537238|E1|Reported Event|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
1111028|NCT00537199|B1|Baseline|OraTest + Visual Exam|Visual oral exam, followed by OraTest Rinse Staining Procedure
1111052|NCT00537082|P2|Participant Flow|FTY720 0.5 mg|Administered orally once daily for 6 months
1111053|NCT00537082|P1|Participant Flow|FTY720 1.25 mg|Administered orally once daily for 6 months
1111054|NCT00537082|O3|Outcome|Placebo|Administered orally once daily for 6 months
1111055|NCT00537082|O2|Outcome|FTY720 0.5 mg|Administered orally once daily for 6 months
1111056|NCT00537082|O1|Outcome|FTY720 1.25 mg|Administered orally once daily for 6 months
1111057|NCT00537082|O3|Outcome|Placebo|Administered orally once daily for 6 months
1111058|NCT00537082|O2|Outcome|FTY720 0.5 mg|Administered orally once daily for 6 months
1111059|NCT00537082|O1|Outcome|FTY720 1.25 mg|Administered orally once daily for 6 months
1111075|NCT00537056|O1|Outcome|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.
1111076|NCT00537056|O1|Outcome|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.
1111077|NCT00537056|O1|Outcome|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan
1111078|NCT00537056|O1|Outcome|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.
1111079|NCT00537056|O1|Outcome|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan
1111080|NCT00537056|E1|Reported Event|F-18 FDG PET/CT and DCE MRI|15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.
1111081|NCT00537030|B1|Baseline|Erwinia Asparaginase|"Patients receive 6 doses of Erwinia asparaginase (dosage 25,000 IU/m2 intramuscularly (IM) on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.~pharmacological study : Correlative studies~laboratory biomarker analysis : Correlative studies~asparaginase : Given IM"
1111082|NCT00537030|P1|Participant Flow|Erwinia Asparaginase|"Patients receive 6 doses of Erwinia asparaginase (dosage 25,000 IU/m2 intramuscularly (IM) on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.~pharmacological study : Correlative studies~laboratory biomarker analysis : Correlative studies~asparaginase : Given IM"
1111083|NCT00537030|O1|Outcome|Erwinia Asparaginase|"Patients receive 6 doses of Erwinia asparaginase (dosage 25,000 IU/m2 intramuscularly (IM) on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.~pharmacological study : Correlative studies~laboratory biomarker analysis : Correlative studies~asparaginase : Given IM"
1111084|NCT00537030|E1|Reported Event|Erwinia Asparaginase|"Patients receive 6 doses of Erwinia asparaginase (dosage 25,000 IU/m2 intramuscularly (IM) on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.~pharmacological study : Correlative studies~laboratory biomarker analysis : Correlative studies~asparaginase : Given IM"
1111085|NCT00537017|B1|Baseline|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
1111086|NCT00537017|P1|Participant Flow|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
1111087|NCT00537017|O1|Outcome|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
1111088|NCT00537017|O1|Outcome|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
1111089|NCT00537017|O1|Outcome|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
1111179|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111090|NCT00537017|O1|Outcome|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
1111091|NCT00537017|O1|Outcome|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
1111092|NCT00537017|O1|Outcome|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
1111093|NCT00537017|O1|Outcome|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
1111094|NCT00537017|O1|Outcome|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
1111095|NCT00537017|E1|Reported Event|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
1111096|NCT00536991|B1|Baseline|Phase I/II: Oral Calcitriol, Ketoconazole, Hydrocortisone|oral calcitriol daily x 3 consecutive days a week in combination with oral ketoconazole, (400 mg TID) + oral hydrocortisone (20mg AM, 10mg PM) in men with androgen independent prostate cancer (AIPC).
1111097|NCT00536991|P1|Participant Flow|Phase I/II: Oral Calcitriol, Ketoconazole, Hydrocortisone|oral calcitriol daily x 3 consecutive days a week in combination with oral ketoconazole, (400 mg TID) + oral hydrocortisone (20mg AM, 10mg PM) in men with androgen independent prostate cancer (AIPC).
1111098|NCT00536991|O1|Outcome|Phase I/II: Oral Calcitriol, Ketoconazole, Hydrocortisone|oral calcitriol daily x 3 consecutive days a week in combination with oral ketoconazole, (400 mg TID) + oral hydrocortisone (20mg AM, 10mg PM) in men with androgen independent prostate cancer (AIPC).
1111099|NCT00536991|O1|Outcome|Phase I/II: Oral Calcitriol, Ketoconazole, Hydrocortisone|oral calcitriol daily x 3 consecutive days a week in combination with oral ketoconazole, (400 mg TID) + oral hydrocortisone (20mg AM, 10mg PM) in men with androgen independent prostate cancer (AIPC).
1111100|NCT00536991|O1|Outcome|Phase I/II: Oral Calcitriol, Ketoconazole, Hydrocortisone|oral calcitriol daily x 3 consecutive days a week in combination with oral ketoconazole, (400 mg TID) + oral hydrocortisone (20mg AM, 10mg PM) in men with androgen independent prostate cancer (AIPC).
1111161|NCT00536471|P3|Participant Flow|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1114325|NCT00529542|O2|Outcome|Placebo|Placebo qd
1111101|NCT00536991|O1|Outcome|Treatment (Calcitriol, Ketoconazole, Hydrocortisone)|"PHASE I: Patients receive calcitriol PO QD on days 1-3, 8-10, 15-17, and 22-24. Patients also receive ketoconazole PO TID on days 1-24 and therapeutic hydrocortisone PO BID on days -1 to 24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive calcitriol and therapeutic hydrocortisone as in phase I. Patients also receive ketoconazole PO TID on days 4-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Calcitriol: Given PO~Ketoconazole: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Therapeutic Hydrocortisone: Given PO"
1111102|NCT00536991|E1|Reported Event|Phase I/II: Oral Calcitriol, Ketoconazole, Hydrocortisone|oral calcitriol daily x 3 consecutive days a week in combination with oral ketoconazole, (400 mg TID) + oral hydrocortisone (20mg AM, 10mg PM) in men with androgen independent prostate cancer (AIPC).
1111103|NCT00536978|B1|Baseline|NK Cell/T-Cell Infusion|Possible Cell Adback - infusion NK cells or T-cells from donor given after blood stem cell transplantation for either Reduced intensity chemotherapy of campath, modified BEAM regimen of Campath-IH 15 mg intravenous (IV) Daily for 3 Days + BEAM Daily for 4 days (BCNU 300 mg/m^2 IV, Etoposide 100 mg/m^2 IV, Ara-C 100 mg/m^2 IV Daily for 4 days and Melphalan 100 mg/m^2 IV Over 30 Minutes for 1 Day) + Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks]; or Non-myeloablative Preparative Regimen [Fludarabine 30 mg/m^2 IV Daily Over 1 Hour for 3 Days; Cyclophosphamide 1000 mg/m^2 IV Daily Over 1 Hour for 3 Days; Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks; Campath-IH 15 mg IV Daily Over 30 Minutes for 3 Days; plus Total Body radiation (TBI)].
1111104|NCT00536978|P1|Participant Flow|NK Cell/T-Cell Infusion|Possible Cell Adback - infusion NK cells or T-cells from donor given after blood stem cell transplantation for either Reduced intensity chemotherapy of campath, modified BEAM regimen of Campath-IH 15 mg intravenous (IV) Daily for 3 Days + BEAM Daily for 4 days (BCNU 300 mg/m^2 IV, Etoposide 100 mg/m^2 IV, Ara-C 100 mg/m^2 IV Daily for 4 days and Melphalan 100 mg/m^2 IV Over 30 Minutes for 1 Day) + Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks]; or Non-myeloablative Preparative Regimen [Fludarabine 30 mg/m^2 IV Daily Over 1 Hour for 3 Days; Cyclophosphamide 1000 mg/m^2 IV Daily Over 1 Hour for 3 Days; Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks; Campath-IH 15 mg IV Daily Over 30 Minutes for 3 Days; plus Total Body radiation (TBI)].
1111105|NCT00536978|O1|Outcome|NK Cell/T-Cell Infusion|Possible Cell Adback - infusion NK cells or T-cells from donor given after blood stem cell transplantation for either Reduced intensity chemotherapy of campath, modified BEAM regimen of Campath-IH 15 mg intravenous (IV) Daily for 3 Days + BEAM Daily for 4 days (BCNU 300 mg/m^2 IV, Etoposide 100 mg/m^2 IV, Ara-C 100 mg/m^2 IV Daily for 4 days and Melphalan 100 mg/m^2 IV Over 30 Minutes for 1 Day) + Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks]; or Non-myeloablative Preparative Regimen [Fludarabine 30 mg/m^2 IV Daily Over 1 Hour for 3 Days; Cyclophosphamide 1000 mg/m^2 IV Daily Over 1 Hour for 3 Days; Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks; Campath-IH 15 mg IV Daily Over 30 Minutes for 3 Days; plus Total Body radiation (TBI)].
1111106|NCT00536978|E1|Reported Event|NK Cell/T-Cell Infusion|Possible Cell Adback - infusion NK cells or T-cells from donor given after blood stem cell transplantation for either Reduced intensity chemotherapy of campath, modified BEAM regimen of Campath-IH 15 mg intravenous (IV) Daily for 3 Days + BEAM Daily for 4 days (BCNU 300 mg/m^2 IV, Etoposide 100 mg/m^2 IV, Ara-C 100 mg/m^2 IV Daily for 4 days and Melphalan 100 mg/m^2 IV Over 30 Minutes for 1 Day) + Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks]; or Non-myeloablative Preparative Regimen [Fludarabine 30 mg/m^2 IV Daily Over 1 Hour for 3 Days; Cyclophosphamide 1000 mg/m^2 IV Daily Over 1 Hour for 3 Days; Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks; Campath-IH 15 mg IV Daily Over 30 Minutes for 3 Days; plus Total Body radiation (TBI)].
1111107|NCT00536575|B1|Baseline|Sorafenib/Bortezomib|The trial was designed as a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients. Phase I consisted of cohorts of 3 patients at each of three dose levels. Patients received bortezomib (Dose Level 1 - 1.3 mg/m2; Dose Level 2 - 1.6 mg/m2) by IV bolus on days 1, 8, 15, and 22 of each 5-week cycle with continuous oral dosing of sorafenib at 200 mg twice daily. Dose level 3 was planned as bortezomib 1.6 mg/m2 IV bolus on days 1, 8, 15, and 22 with sorafenib 400 mg by mouth twice daily throughout each 5-week cycle.
1111108|NCT00536575|P1|Participant Flow|Sorafenib/Bortezomib|The trial was designed as a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients. Phase I consisted of cohorts of 3 patients at each of three dose levels. Patients received bortezomib (Dose Level 1 - 1.3 mg/m2; Dose Level 2 - 1.6 mg/m2) by IV bolus on days 1, 8, 15, and 22 of each 5-week cycle with continuous oral dosing of sorafenib at 200 mg twice daily. Dose level 3 was planned as bortezomib 1.6 mg/m2 IV bolus on days 1, 8, 15, and 22 with sorafenib 400 mg by mouth twice daily throughout each 5-week cycle.
1111109|NCT00536575|O1|Outcome|Sorafenib/Bortezomib|The trial was designed as a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients. Phase I consisted of cohorts of 3 patients at each of three dose levels. Patients received bortezomib (Dose Level 1 - 1.3 mg/m2; Dose Level 2 - 1.6 mg/m2) by IV bolus on days 1, 8, 15, and 22 of each 5-week cycle with continuous oral dosing of sorafenib at 200 mg twice daily. Dose level 3 was planned as bortezomib 1.6 mg/m2 IV bolus on days 1, 8, 15, and 22 with sorafenib 400 mg by mouth twice daily throughout each 5-week cycle.
1111110|NCT00536575|E1|Reported Event|Sorafenib/Bortezomib|The trial was designed as a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients. Phase I consisted of cohorts of 3 patients at each of three dose levels. Patients received bortezomib (Dose Level 1 - 1.3 mg/m2; Dose Level 2 - 1.6 mg/m2) by IV bolus on days 1, 8, 15, and 22 of each 5-week cycle with continuous oral dosing of sorafenib at 200 mg twice daily. Dose level 3 was planned as bortezomib 1.6 mg/m2 IV bolus on days 1, 8, 15, and 22 with sorafenib 400 mg by mouth twice daily throughout each 5-week cycle.
1111111|NCT00536510|B3|Baseline|Total|Total of all reporting groups
1111112|NCT00536510|B2|Baseline|Placebo|"All patients received placebo for a 4 week run-in period before randomization.~Drug: Comparator: placebo~Treatment Period 1: one 20 mg /1 g tablet placebo to laropiprant/niacin once daily for 4 weeks~Treatment Period 2: two 20 mg /1 g tablets of placebo to laropiprant/niacin once daily for 8 weeks."
1111753|NCT00535405|E3|Reported Event|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
1111113|NCT00536510|B1|Baseline|MK0524A 2 g|"All patients received placebo for a 4 week run-in period before randomization.~Drug: laropiprant/niacin (MK0524A)~Treatment Period 1: one 20 mg /1 g tablet of laropiprant/niacin once daily for 4 weeks.~Treatment Period 2: two 20 mg /1 g tablets of laropiprant/niacin once daily for 8 weeks."
1111114|NCT00536510|P2|Participant Flow|Placebo|"All patients received placebo for a 4 week run-in period before randomization.~Drug: Comparator: placebo~Treatment Period 1: one 20 mg /1 g tablet placebo to laropiprant/niacin once daily for 4 weeks~Treatment Period 2: two 20 mg /1 g tablets of placebo to laropiprant/niacin once daily for 8 weeks."
1111115|NCT00536510|P1|Participant Flow|MK0524A 2 g|"All patients received placebo for a 4 week run-in period before randomization.~Drug: laropiprant/niacin (MK0524A)~Treatment Period 1: one 20 mg /1 g tablet of laropiprant/niacin once daily for 4 weeks.~Treatment Period 2: two 20 mg /1 g tablets of laropiprant/niacin once daily for 8 weeks."
1111116|NCT00536510|O2|Outcome|Placebo|"All patients received placebo for a 4 week run-in period before randomization.~Drug: Comparator: placebo~Treatment Period 1: one 20 mg /1 g tablet placebo to laropiprant/niacin once daily for 4 weeks~Treatment Period 2: two 20 mg /1 g tablets of placebo to laropiprant/niacin once daily for 8 weeks."
1111117|NCT00536510|O1|Outcome|MK0524A 2 g|"All patients received placebo for a 4 week run-in period before randomization.~Drug: laropiprant/niacin (MK0524A)~Treatment Period 1: one 20 mg /1 g tablet of laropiprant/niacin once daily for 4 weeks.~Treatment Period 2: two 20 mg /1 g tablets of laropiprant/niacin once daily for 8 weeks."
1111118|NCT00536510|O2|Outcome|Placebo|"All patients received placebo for a 4 week run-in period before randomization.~Drug: Comparator: placebo~Treatment Period 1: one 20 mg /1 g tablet placebo to laropiprant/niacin once daily for 4 weeks~Treatment Period 2: two 20 mg /1 g tablets of placebo to laropiprant/niacin once daily for 8 weeks."
1111119|NCT00536510|O1|Outcome|MK0524A 2 g|"All patients received placebo for a 4 week run-in period before randomization.~Drug: laropiprant/niacin (MK0524A)~Treatment Period 1: one 20 mg /1 g tablet of laropiprant/niacin once daily for 4 weeks.~Treatment Period 2: two 20 mg /1 g tablets of laropiprant/niacin once daily for 8 weeks."
1111120|NCT00536510|E2|Reported Event|Placebo|"All patients received placebo for a 4 week run-in period before randomization.~Drug: Comparator: placebo~Treatment Period 1: one 20 mg /1 g tablet placebo to laropiprant/niacin once daily for 4 weeks~Treatment Period 2: two 20 mg /1 g tablets of placebo to laropiprant/niacin once daily for 8 weeks."
1111121|NCT00536510|E1|Reported Event|MK0524A 2 g|"All patients received placebo for a 4 week run-in period before randomization.~Drug: laropiprant/niacin (MK0524A)~Treatment Period 1: one 20 mg /1 g tablet of laropiprant/niacin once daily for 4 weeks.~Treatment Period 2: two 20 mg /1 g tablets of laropiprant/niacin once daily for 8 weeks."
1111122|NCT00536484|B3|Baseline|Total|Total of all reporting groups
1111123|NCT00536484|B2|Baseline|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
1111124|NCT00536484|B1|Baseline|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
1111125|NCT00536484|P2|Participant Flow|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
1111126|NCT00536484|P1|Participant Flow|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
1111472|NCT00536263|E1|Reported Event|PEG 1.0 mcg/kg QW x24 Weeks|
1111473|NCT00536198|B3|Baseline|Total|Total of all reporting groups
1114657|NCT00529087|O3|Outcome|Placebo|Once daily
1111127|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
1111128|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
1111129|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
1111130|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
1111131|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
1111132|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
1111133|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
1111134|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
1111135|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
1111136|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
1111137|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
1111138|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
1111139|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
1111140|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
1111141|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
1111142|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
1111143|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
1111144|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
1111145|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
1111146|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
1111147|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
1111148|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
1111149|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
1111150|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
1111151|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
1111152|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
1111153|NCT00536484|E2|Reported Event|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
1111154|NCT00536484|E1|Reported Event|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
1111155|NCT00536471|B5|Baseline|Total|Total of all reporting groups
1111156|NCT00536471|B4|Baseline|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111157|NCT00536471|B3|Baseline|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111158|NCT00536471|B2|Baseline|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111159|NCT00536471|B1|Baseline|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111160|NCT00536471|P4|Participant Flow|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1114326|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
1111162|NCT00536471|P2|Participant Flow|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111163|NCT00536471|P1|Participant Flow|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111164|NCT00536471|O4|Outcome|Placebo (Rescued)|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111165|NCT00536471|O3|Outcome|Placebo (Not Rescued)|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111166|NCT00536471|O2|Outcome|Duloxetine (Escalated)|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which participants were increased to duloxetine 120 mg QD, PO for 6 months
1111167|NCT00536471|O1|Outcome|Duloxetine (Not Escalated)|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which participants remained on duloxetine 60 mg QD, PO for 6 months.
1111168|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111169|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111170|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111171|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111172|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111173|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111174|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111175|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111176|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111177|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111178|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111180|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111181|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111182|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111183|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111184|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111185|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111186|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111187|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111188|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111189|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111190|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1112128|NCT00534599|P1|Participant Flow|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
1111191|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111192|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111193|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111194|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111195|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111196|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111197|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111198|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111199|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111200|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111201|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111202|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111203|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111204|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111205|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111206|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111207|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111265|NCT00536471|O4|Outcome|Group B - Standardized Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression expressed in units of standard deviation in the Duloxetine 60 mg group.
1111208|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111209|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111210|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111211|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111212|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111213|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111214|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111215|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111216|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111217|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111218|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111219|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111220|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111221|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111222|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111223|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111224|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111225|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111226|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111227|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111228|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111229|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111230|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111231|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111232|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111233|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111234|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111235|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111266|NCT00536471|O3|Outcome|Group B - Ordinary Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression in the Duloxetine 60 mg group.
1111236|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111237|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111238|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111239|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111240|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111241|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111242|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111243|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111244|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111245|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111246|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111247|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111248|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111249|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111250|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111251|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111252|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111253|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111254|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111255|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111256|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111257|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111258|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111259|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111260|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111261|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111262|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111263|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111264|NCT00536471|O1|Outcome|Group B - Percent of Total Effect|The percentage of the total treatment effect explained by the direct and indirect effects of treatment in the duloxetine 60 mg group.
1111267|NCT00536471|O2|Outcome|Group A - Standardized Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression expressed in units of standard deviation in the Duloxetine 60 mg group.
1111268|NCT00536471|O1|Outcome|Group A - Ordinary Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression in the Duloxetine 60 mg group.
1111269|NCT00536471|O1|Outcome|Group B - Percent of Total Effect|The percentage of the total treatment effect explained by the direct and indirect effects of treatment in the duloxetine 60 mg group.
1111270|NCT00536471|O4|Outcome|Group B - Standardized Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression expressed in units of standard deviation in the Duloxetine 60 mg group.
1111271|NCT00536471|O3|Outcome|Group B - Ordinary Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression in the Duloxetine 60 mg group.
1111272|NCT00536471|O2|Outcome|Group A - Standardized Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression expressed in units of standard deviation in the Duloxetine 60 mg group.
1111273|NCT00536471|O1|Outcome|Group A - Ordinary Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression in the Duloxetine 60 mg group.
1111274|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111275|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111276|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111277|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111435|NCT00536263|P2|Participant Flow|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
1111278|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111279|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111280|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111281|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111282|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111283|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111284|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111285|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111286|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111287|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111288|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111289|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111290|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111291|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111292|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111293|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111294|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111295|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111417|NCT00536341|B3|Baseline|Total|Total of all reporting groups
1111296|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111297|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111298|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111299|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111300|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111301|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111302|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111303|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111304|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111305|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111436|NCT00536263|P1|Participant Flow|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
1111306|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111307|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111308|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111309|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111310|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111311|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111312|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111313|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111314|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111315|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111316|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111317|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111318|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111319|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111320|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111321|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111322|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111323|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111418|NCT00536341|B2|Baseline|Dose Level 2|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 cycle 1, 5.0 mg PO days 8-28 cycles 2-6
1111324|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111325|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111326|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111327|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111328|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111329|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111330|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111331|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111332|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111333|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111334|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111335|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111336|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111337|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111338|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111339|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111340|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111341|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111342|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111343|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111344|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111345|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111346|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111347|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111348|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111349|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111350|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111351|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111419|NCT00536341|B1|Baseline|Dose Level 1|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 all cycles 1-6
1111352|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111353|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111354|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111355|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111356|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111357|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111358|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111359|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111360|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111361|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111362|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111363|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111364|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111365|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111366|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111367|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111368|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111369|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111370|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111371|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111372|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111373|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111374|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111375|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111376|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111377|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111378|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111379|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111420|NCT00536341|P2|Participant Flow|Dose Level 2|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 cycle 1, 5.0 mg PO days 8-28 cycles 2-6
1111380|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111381|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111382|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111383|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111384|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111385|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111386|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111387|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111388|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111389|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111390|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111391|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111392|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111393|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111394|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111395|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111396|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111397|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111398|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111399|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111400|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111401|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111402|NCT00536471|E2|Reported Event|Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
1111403|NCT00536471|E1|Reported Event|Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
1111404|NCT00536380|B4|Baseline|Total|Total of all reporting groups
1111405|NCT00536380|B3|Baseline|20-mg Desloratadine|20-mg Desloratadine once daily
1111406|NCT00536380|B2|Baseline|10-mg Desloratadine|10-mg Desloratadine once daily
1111407|NCT00536380|B1|Baseline|5-mg Desloratadine|5-mg Desloratadine once daily
1111408|NCT00536380|P3|Participant Flow|20-mg Desloratadine|20-mg Desloratadine once daily
1111409|NCT00536380|P2|Participant Flow|10-mg Desloratadine|10-mg Desloratadine once daily
1111410|NCT00536380|P1|Participant Flow|5-mg Desloratadine|5-mg Desloratadine once daily
1111411|NCT00536380|O3|Outcome|10-mg Desloratadine|10-mg Desloratadine once daily
1111412|NCT00536380|O2|Outcome|20-mg Desloratadine|20-mg Desloratadine once daily
1111413|NCT00536380|O1|Outcome|5-mg Desloratadine|5-mg Desloratadine once daily
1111414|NCT00536380|E3|Reported Event|20-mg Desloratadine|20-mg Desloratadine once daily
1111415|NCT00536380|E2|Reported Event|10-mg Desloratadine|10-mg Desloratadine once daily
1111416|NCT00536380|E1|Reported Event|5-mg Desloratadine|5-mg Desloratadine once daily
1111421|NCT00536341|P1|Participant Flow|Dose Level 1|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 all cycles 1-6
1111422|NCT00536341|O1|Outcome|All Patients|
1111423|NCT00536341|O1|Outcome|All Patients|
1111424|NCT00536341|O2|Outcome|Dose Level 2|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 cycle 1, 5.0 mg PO days 8-28 cycles 2-6
1111425|NCT00536341|O1|Outcome|Dose Level 1|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 all cycles 1-6
1111426|NCT00536341|O2|Outcome|Dose Level 2|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 cycle 1, 5.0 mg PO days 8-28 cycles 2-6
1111427|NCT00536341|O1|Outcome|Dose Level 1|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 all cycles 1-6
1111428|NCT00536341|E2|Reported Event|Dose Level 2|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 cycle 1, 5.0 mg PO days 8-28 cycles 2-6
1111429|NCT00536341|E1|Reported Event|Dose Level 1|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 all cycles 1-6
1111430|NCT00536263|B4|Baseline|Total|Total of all reporting groups
1111431|NCT00536263|B3|Baseline|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up; treated participants.
1111432|NCT00536263|B2|Baseline|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up; treated participants
1111433|NCT00536263|B1|Baseline|PEG 1.0 mcg/kg QW * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up; treated participants
1111434|NCT00536263|P3|Participant Flow|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
1111440|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
1111441|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
1111442|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
1111443|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
1111444|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
1111445|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
1111446|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
1111447|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
1111448|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
1111449|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
1111450|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
1111451|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
1111452|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
1111453|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
1111454|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
1111455|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
1111456|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
1111457|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
1111458|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
1111459|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
1111460|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
1111461|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
1111462|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
1111463|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
1111464|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
1111465|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
1111466|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
1111467|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
1111468|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
1111469|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
1111470|NCT00536263|E3|Reported Event|PEG 1.5 mcg/kg QW x48 Weeks|
1111471|NCT00536263|E2|Reported Event|PEG 1.5 mcg/kg QW x24 Weeks|
1111474|NCT00536198|B2|Baseline|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
1111475|NCT00536198|B1|Baseline|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
1111476|NCT00536198|P2|Participant Flow|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
1111477|NCT00536198|P1|Participant Flow|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
1111478|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
1111479|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
1111480|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
1111564|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
1111565|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
1111481|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
1111482|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
1111483|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
1111484|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
1111485|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
1111486|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
1111487|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
1111488|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
1111489|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
1111490|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
1116374|NCT00525798|O1|Outcome|SMC021|1 tablet of 0,80 mg SMC021 daily
1111491|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
1111492|NCT00536198|O2|Outcome|Placebo|Participants will take similarly looking placebo during the symptomatic period Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg.
1111493|NCT00536198|O1|Outcome|Sertraline|Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue.
1111494|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
1111495|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
1111496|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
1111566|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
1111567|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
1111497|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
1111498|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
1111499|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
1111500|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
1111501|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
1111502|NCT00536198|E2|Reported Event|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
1111503|NCT00536198|E1|Reported Event|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
1111504|NCT00536172|B3|Baseline|Total|Total of all reporting groups
1111505|NCT00536172|B2|Baseline|Placebo|"Participants will receive treatment with placebo~Placebo: Placebo distribution matches the active medication."
1111506|NCT00536172|B1|Baseline|Escitalopram|"Participants will receive treatment with escitalopram~Escitalopram: Participants take 10 mg for 1 week and then 20 mg for 15 weeks."
1111507|NCT00536172|P2|Participant Flow|Placebo|"Participants will receive treatment with placebo~Placebo: Placebo distribution matches the active medication."
1111508|NCT00536172|P1|Participant Flow|Escitalopram|"Participants will receive treatment with escitalopram~Escitalopram: Participants take 10 mg for 1 week and then 20 mg for 15 weeks."
1111509|NCT00536172|O2|Outcome|Placebo|"Participants will receive treatment with placebo~Placebo: Placebo distribution matches the active medication."
1111510|NCT00536172|O1|Outcome|Escitalopram|"Participants will receive treatment with escitalopram~Escitalopram: Participants take 10 mg for 1 week and then 20 mg for 15 weeks."
1111511|NCT00536172|E2|Reported Event|Placebo|"Participants will receive treatment with placebo~Placebo: Placebo distribution matches the active medication."
1111512|NCT00536172|E1|Reported Event|Escitalopram|"Participants will receive treatment with escitalopram~Escitalopram: Participants take 10 mg for 1 week and then 20 mg for 15 weeks."
1111513|NCT00536120|B3|Baseline|Total|Total of all reporting groups
1111514|NCT00536120|B2|Baseline|Vaccinations Only|Participants received only vaccinations with neoantigen and recall antigen (KLH and Td, according to manufacturer's prescribing information) at Month 0 for both KLH and Td, and 14 and 28 days later for KLH. They did not receive any treatment for their MS and remained in the study through Month 2.
1111515|NCT00536120|B1|Baseline|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
1111516|NCT00536120|P2|Participant Flow|Vaccinations Only|Participants received only vaccinations with neoantigen and recall antigen (KLH and Td, according to manufacturer's prescribing information) at Month 0 for both KLH and Td, and 14 and 28 days later for KLH. They did not receive any treatment for their MS and remained in the study through Month 2.
1111517|NCT00536120|P1|Participant Flow|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
1111518|NCT00536120|O1|Outcome|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
1111519|NCT00536120|O1|Outcome|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
1111568|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
1111569|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
1111520|NCT00536120|O1|Outcome|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
1111521|NCT00536120|O1|Outcome|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
1111522|NCT00536120|O2|Outcome|Vaccinations Only|Participants received only vaccinations with neoantigen and recall antigen (KLH and Td, according to manufacturer's prescribing information) at Month 0 for both KLH and Td, and 14 and 28 days later for KLH. They did not receive any treatment for their MS and remained in the study through Month 2.
1111523|NCT00536120|O1|Outcome|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
1111524|NCT00536120|O2|Outcome|Vaccinations Only|Participants received only vaccinations with neoantigen and recall antigen (KLH and Td, according to manufacturer's prescribing information) at Month 0 for both KLH and Td, and 14 and 28 days later for KLH. They did not receive any treatment for their MS and remained in the study through Month 2.
1111525|NCT00536120|O1|Outcome|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
1111526|NCT00536120|E2|Reported Event|Vaccinations Only|Participants received only vaccinations with neoantigen and recall antigen (KLH and Td, according to manufacturer's prescribing information) at specified timepoints. They did not receive any treatment for their MS.
1111527|NCT00536120|E1|Reported Event|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at specified timepoints following the 7th dose.
1111528|NCT00536107|B3|Baseline|Total|Total of all reporting groups
1111529|NCT00536107|B2|Baseline|Docetaxel|docetaxel 60mg/m sq
1111530|NCT00536107|B1|Baseline|Gefitinib|gefitinib 250mg
1111531|NCT00536107|P2|Participant Flow|Docetaxel|docetaxel 60mg/m sq
1111532|NCT00536107|P1|Participant Flow|Gefitinib|gefitinib 250mg
1111533|NCT00536107|O2|Outcome|Docetaxel|docetaxel 60mg/m sq
1111534|NCT00536107|O1|Outcome|Gefitinib|gefitinib 250mg
1111535|NCT00536107|O2|Outcome|Docetaxel|docetaxel 60mg/m sq
1111536|NCT00536107|O1|Outcome|Gefitinib|gefitinib 250mg
1111537|NCT00536107|E2|Reported Event|Docetaxel|docetaxel 60mg/m sq
1111538|NCT00536107|E1|Reported Event|Gefitinib|gefitinib 250mg
1111539|NCT00535938|B3|Baseline|Total|Total of all reporting groups
1111540|NCT00535938|B2|Baseline|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
1111541|NCT00535938|B1|Baseline|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
1111542|NCT00535938|P2|Participant Flow|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
1111543|NCT00535938|P1|Participant Flow|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
1111544|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
1111545|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
1111546|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
1111547|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
1111548|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
1111549|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
1111550|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
1111551|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
1111552|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
1111553|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
1111554|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
1111555|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
1111556|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
1111557|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
1111558|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
1111559|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
1111560|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
1111561|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
1111562|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
1111563|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
1111611|NCT00535821|B3|Baseline|Total|Total of all reporting groups
1111570|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
1111571|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
1111572|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
1111573|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
1111574|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
1111575|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
1111576|NCT00535938|E2|Reported Event|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
1111577|NCT00535938|E1|Reported Event|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
1111578|NCT00535873|B1|Baseline|Lenalidomide|Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
1111579|NCT00535873|P1|Participant Flow|Lenalidomide|Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
1111580|NCT00535873|O1|Outcome|Lenalidomide|Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
1111581|NCT00535873|E1|Reported Event|Lenalidomide|Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
1111582|NCT00535847|B4|Baseline|Total|Total of all reporting groups
1111583|NCT00535847|B3|Baseline|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
1111584|NCT00535847|B2|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
1111585|NCT00535847|B1|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
1111586|NCT00535847|P3|Participant Flow|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
1111587|NCT00535847|P2|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
1111630|NCT00535782|O2|Outcome|Placebo + MTX|Participants received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for the first 24 weeks.
1116375|NCT00525798|E2|Reported Event|Placebo|1 tablet of placebo daily
1111588|NCT00535847|P1|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
1111589|NCT00535847|O3|Outcome|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
1111590|NCT00535847|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
1111591|NCT00535847|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
1111592|NCT00535847|O4|Outcome|Did Not Achieve eRVR/Did Not Achieve SVR|All subjects in “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week”, “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week” and “Other” reporting groups who neither achieved eRVR nor SVR in this study (VX06-950-107 [NCT00535847]).
1111593|NCT00535847|O3|Outcome|Did Not Achieve eRVR/Achieved SVR|All subjects in “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week”, “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week” and “Other” reporting groups who did not achieve eRVR but achieved SVR in this study (VX06-950-107 [NCT00535847]).
1111594|NCT00535847|O2|Outcome|Achieved eRVR/Did Not Achieve SVR|All subjects in “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week”, “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week” and “Other” reporting groups who achieved eRVR but did not achieve SVR in this study (VX06-950-107 [NCT00535847]).
1111612|NCT00535821|B2|Baseline|EGDT|"A 6-hour resuscitation protocol utilizing CVP/ScvO2~Central line with CVP and continuous ScvO2 monitoring: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring"
1111595|NCT00535847|O1|Outcome|Achieved eRVR/Achieved SVR|All subjects in “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week”, “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week” and “Other” reporting groups who achieved eRVR and SVR in this study (VX06-950-107 [NCT00535847]).
1111596|NCT00535847|O3|Outcome|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
1111597|NCT00535847|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
1111598|NCT00535847|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
1111599|NCT00535847|O3|Outcome|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
1111600|NCT00535847|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
1111601|NCT00535847|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
1111602|NCT00535847|O3|Outcome|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
1111603|NCT00535847|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
1111604|NCT00535847|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
1111631|NCT00535782|O1|Outcome|TCZ + MTX|Participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus 7.5-25 mg of methotrexate (MTX) weekly for the first 24 weeks.
1111605|NCT00535847|O3|Outcome|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
1111606|NCT00535847|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
1111607|NCT00535847|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
1111608|NCT00535847|E3|Reported Event|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
1111609|NCT00535847|E2|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
1111610|NCT00535847|E1|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
1111613|NCT00535821|B1|Baseline|MiCHO|"A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM)~Esophageal Doppler monitoring - CardioQ, Deltex Inc: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM"
1111614|NCT00535821|P2|Participant Flow|EGDT|"A 6-hour resuscitation protocol utilizing CVP/ScvO2~Central line with CVP and continuous ScvO2 monitoring: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring"
1111615|NCT00535821|P1|Participant Flow|MiCHO|"A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM)~Esophageal Doppler monitoring - CardioQ, Deltex Inc: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM"
1111616|NCT00535821|O2|Outcome|EGDT|"A 6-hour resuscitation protocol utilizing CVP/ScvO2~Central line with CVP and continuous ScvO2 monitoring: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring"
1111617|NCT00535821|O1|Outcome|MiCHO|"A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM)~Esophageal Doppler monitoring - CardioQ, Deltex Inc: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM"
1111618|NCT00535821|E2|Reported Event|EGDT|"A 6-hour resuscitation protocol utilizing CVP/ScvO2~Central line with CVP and continuous ScvO2 monitoring: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring"
1111619|NCT00535821|E1|Reported Event|MiCHO|"A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM)~Esophageal Doppler monitoring - CardioQ, Deltex Inc: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM"
1111620|NCT00535782|B3|Baseline|Total|Total of all reporting groups
1111621|NCT00535782|B2|Baseline|Placebo + MTX|During Part 1 of the study participants received placebo intravenous (IV) infusion every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks. During Part 2, from Week 24 to Week 104, participants received 8 mg/kg TCZ IV every 4 weeks plus 7.5-25 mg MTX weekly.
1111622|NCT00535782|B1|Baseline|TCZ + MTX|During Part 1 of the study participants received 8 mg/kg tocilizumab (TCZ) by intravenous (IV) infusion every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks. During Part 2, from Week 24 to Week 104, participants received open-label 8 mg/kg TCZ every 4 weeks plus 7.5-25 mg MTX weekly.
1111623|NCT00535782|P3|Participant Flow|Part 2: TCZ + MTX|During Part 2 of the study, from Week 24 to Week 104, all participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly.
1111624|NCT00535782|P2|Participant Flow|Part 1: Placebo + MTX|During Part 1 of the study participants in this group received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks.
1111625|NCT00535782|P1|Participant Flow|Part 1: TCZ + MTX|During Part 1 of the study participants in this group received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks.
1111626|NCT00535782|O2|Outcome|Placebo + MTX|Participants received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for the first 24 weeks.
1111627|NCT00535782|O1|Outcome|TCZ + MTX|Participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus 7.5-25 mg of methotrexate (MTX) weekly for the first 24 weeks.
1111628|NCT00535782|O2|Outcome|Placebo + MTX|Participants received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for the first 24 weeks.
1111629|NCT00535782|O1|Outcome|TCZ + MTX|Participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus 7.5-25 mg of methotrexate (MTX) weekly for the first 24 weeks.
1111632|NCT00535782|O2|Outcome|Placebo + MTX|Participants received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for the first 24 weeks.
1111633|NCT00535782|O1|Outcome|TCZ + MTX|Participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus 7.5-25 mg of methotrexate (MTX) weekly for the first 24 weeks.
1111634|NCT00535782|O2|Outcome|Placebo + MTX|Participants received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for the first 24 weeks.
1111635|NCT00535782|O1|Outcome|TCZ + MTX|Participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus 7.5-25 mg of methotrexate (MTX) weekly for the first 24 weeks.
1111636|NCT00535782|E3|Reported Event|All TCZ + MTX|Includes patients who received at least one dose of active tocilizumab (TCZ) regardless of when they received it during the study and whether it was double-blind (Part 1) or open-label (Part 2). Participants received 8 mg/kg TCZ by intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly.
1111637|NCT00535782|E2|Reported Event|Part 1: Placebo + MTX|During Part 1 of the study participants in this group received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks.
1111638|NCT00535782|E1|Reported Event|Part 1: TCZ + MTX|During Part 1 of the study participants in this group received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks.
1111639|NCT00535769|B3|Baseline|Total|Total of all reporting groups
1111640|NCT00535769|B2|Baseline|Electronic Monitor + Text Message|The text message group of subjects will receive the study sunscreen with the attached electronic monitor. In addition, this group will receive daily text messages on their cellular phone to remind them to apply the sunscreen. The text message will also contain the daily weather information. This group will also be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
1111641|NCT00535769|B1|Baseline|Control: Electronic Monitor+ no Text Message|The control group of subjects will receive the study sunscreen with the attached electronic monitor. They will be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If the subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
1111667|NCT00535730|O2|Outcome|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
1112129|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
1111642|NCT00535769|P2|Participant Flow|Electronic Monitor + Text Message|The text message group of subjects will receive the study sunscreen with the attached electronic monitor. In addition, this group will receive daily text messages on their cellular phone to remind them to apply the sunscreen. The text message will also contain the daily weather information. This group will also be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
1111643|NCT00535769|P1|Participant Flow|Control: Electronic Monitor+ no Text Message|The control group of subjects will receive the study sunscreen with the attached electronic monitor. They will be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If the subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
1111644|NCT00535769|O2|Outcome|Electronic Monitor + Text Message|The text message group of subjects will receive the study sunscreen with the attached electronic monitor. In addition, this group will receive daily text messages on their cellular phone to remind them to apply the sunscreen. The text message will also contain the daily weather information. This group will also be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
1111645|NCT00535769|O1|Outcome|Control: Electronic Monitor+ no Text Message|The control group of subjects will receive the study sunscreen with the attached electronic monitor. They will be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If the subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
1111646|NCT00535769|O1|Outcome|Usefulness of Text Messaging System|Patients with text reminder system were asked their opinion of the usefulness of message reminder from 0-10 (0, not useful at all; 10,most useful)
1111647|NCT00535769|O2|Outcome|Electronic Monitor + Text Message|The text message group of subjects will receive the study sunscreen with the attached electronic monitor. In addition, this group will receive daily text messages on their cellular phone to remind them to apply the sunscreen. The text message will also contain the daily weather information. This group will also be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
1111648|NCT00535769|O1|Outcome|Control: Electronic Monitor+ no Text Message|The control group of subjects will receive the study sunscreen with the attached electronic monitor. They will be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If the subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
1111649|NCT00535769|E2|Reported Event|Electronic Monitor + Text Message|The text message group of subjects will receive the study sunscreen with the attached electronic monitor. In addition, this group will receive daily text messages on their cellular phone to remind them to apply the sunscreen. The text message will also contain the daily weather information. This group will also be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
1111650|NCT00535769|E1|Reported Event|Control: Electronic Monitor+ no Text Message|The control group of subjects will receive the study sunscreen with the attached electronic monitor. They will be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If the subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
1111651|NCT00535730|B3|Baseline|Total|Total of all reporting groups
1111652|NCT00535730|B2|Baseline|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
1111725|NCT00535405|O1|Outcome|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
1111653|NCT00535730|B1|Baseline|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
1111654|NCT00535730|P2|Participant Flow|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
1111655|NCT00535730|P1|Participant Flow|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
1111656|NCT00535730|O2|Outcome|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
1111657|NCT00535730|O1|Outcome|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
1111658|NCT00535730|O2|Outcome|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
1111659|NCT00535730|O1|Outcome|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
1111660|NCT00535730|O2|Outcome|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
1111661|NCT00535730|O1|Outcome|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
1111662|NCT00535730|O2|Outcome|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
1111663|NCT00535730|O1|Outcome|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
1111664|NCT00535730|O1|Outcome|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
1111665|NCT00535730|O2|Outcome|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
1111666|NCT00535730|O1|Outcome|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
1111750|NCT00535405|O1|Outcome|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
1111668|NCT00535730|O1|Outcome|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
1111669|NCT00535730|E2|Reported Event|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
1111670|NCT00535730|E1|Reported Event|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
1111671|NCT00535652|B1|Baseline|Ertapenem|"Administration of 1 gram ertapenem I.V.~Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min."
1111672|NCT00535652|P1|Participant Flow|Ertapenem|"Administration of 1 gram ertapenem I.V.~Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min."
1111673|NCT00535652|O1|Outcome|Ertapenem|"Administration of 1 gram ertapenem I.V.~Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min."
1111674|NCT00535652|E1|Reported Event|Ertapenem|"Administration of 1 gram ertapenem I.V.~Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min."
1111675|NCT00535587|B5|Baseline|Total|Total of all reporting groups
1111676|NCT00535587|B4|Baseline|Placebo Pill and Attention Control|
1111677|NCT00535587|B3|Baseline|Placebo Pill and Exercise|
1111678|NCT00535587|B2|Baseline|Mestinon and Attention Control|
1111679|NCT00535587|B1|Baseline|Mestinon & Exercise|
1111680|NCT00535587|P4|Participant Flow|Placebo Pill and Attention Control|
1111681|NCT00535587|P3|Participant Flow|Placebo Pill and Exercise|
1111682|NCT00535587|P2|Participant Flow|Mestinon and Attention Control|
1111683|NCT00535587|P1|Participant Flow|Mestinon & Exercise|
1111684|NCT00535587|O2|Outcome|Placebo Pill/Attention Control|
1111685|NCT00535587|O1|Outcome|Mestinon/Exercise|
1111686|NCT00535587|E4|Reported Event|Placebo Pill and Attention Control|
1111687|NCT00535587|E3|Reported Event|Placebo Pill and Exercise|
1111688|NCT00535587|E2|Reported Event|Mestinon and Attention Control|
1111689|NCT00535587|E1|Reported Event|Mestinon & Exercise|
1111690|NCT00535496|B3|Baseline|Total|Total of all reporting groups
1111691|NCT00535496|B2|Baseline|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
1111692|NCT00535496|B1|Baseline|Sugammadex 1.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
1111693|NCT00535496|P4|Participant Flow|Sugammadex 4.0 mg/kg, TOF-Watch® SX Non-dominant Arm|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight. The TOF-Watch® SX was on the non-dominant forearm and the PNS was on the dominant forearm.
1111694|NCT00535496|P3|Participant Flow|Sugammadex 4.0 mg/kg, TOF-Watch® SX Dominant Arm|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight. The TOF-Watch® SX was on the dominant forearm and the PNS was on the non-dominant forearm.
1111726|NCT00535405|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
1111727|NCT00535405|O4|Outcome|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
1111695|NCT00535496|P2|Participant Flow|Sugammadex 1.0 mg/kg, TOF-Watch® SX Non-dominant Arm|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight. The TOF-Watch® SX was on the non-dominant forearm and the PNS was on the dominant forearm.
1111696|NCT00535496|P1|Participant Flow|Sugammadex 1.0 mg/kg, TOF-Watch® SX Dominant Arm|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight. The Train of Four (TOF)-Watch® SX was on the dominant forearm and the peripheral nerve stimulator (PNS) was on the non-dominant forearm.
1111697|NCT00535496|O1|Outcome|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
1111698|NCT00535496|O1|Outcome|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
1111699|NCT00535496|O2|Outcome|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
1111700|NCT00535496|O1|Outcome|Sugammadex 1.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
1111701|NCT00535496|O2|Outcome|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
1111751|NCT00535405|E5|Reported Event|Atorvastatin 40 mg|Atorvastatin 40 mg once daily for 12 weeks
1111752|NCT00535405|E4|Reported Event|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
1111702|NCT00535496|O1|Outcome|Sugammadex 1.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
1111703|NCT00535496|O1|Outcome|Sugammadex 1.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
1111704|NCT00535496|O2|Outcome|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
1111705|NCT00535496|O1|Outcome|Sugammadex 1.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
1111706|NCT00535496|O1|Outcome|Sugammadex 1.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
1111707|NCT00535496|O1|Outcome|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
1111708|NCT00535496|E2|Reported Event|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
1111709|NCT00535496|E1|Reported Event|Sugammadex 1.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
1111710|NCT00535405|B6|Baseline|Total|Total of all reporting groups
1111711|NCT00535405|B5|Baseline|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
1111712|NCT00535405|B4|Baseline|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
1111713|NCT00535405|B3|Baseline|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
1111714|NCT00535405|B2|Baseline|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
1111715|NCT00535405|B1|Baseline|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
1111716|NCT00535405|P5|Participant Flow|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
1111717|NCT00535405|P4|Participant Flow|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
1111718|NCT00535405|P3|Participant Flow|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
1111719|NCT00535405|P2|Participant Flow|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
1111720|NCT00535405|P1|Participant Flow|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
1111721|NCT00535405|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
1111722|NCT00535405|O4|Outcome|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
1111723|NCT00535405|O3|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
1111724|NCT00535405|O2|Outcome|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
1111728|NCT00535405|O3|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
1111729|NCT00535405|O2|Outcome|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
1111730|NCT00535405|O1|Outcome|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
1111731|NCT00535405|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
1111732|NCT00535405|O4|Outcome|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
1111733|NCT00535405|O3|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
1111734|NCT00535405|O2|Outcome|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
1111735|NCT00535405|O1|Outcome|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
1111736|NCT00535405|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
1111737|NCT00535405|O4|Outcome|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
1111738|NCT00535405|O3|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
1111739|NCT00535405|O2|Outcome|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
1111740|NCT00535405|O1|Outcome|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
1111741|NCT00535405|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
1111742|NCT00535405|O4|Outcome|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
1111743|NCT00535405|O3|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
1111744|NCT00535405|O2|Outcome|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
1111745|NCT00535405|O1|Outcome|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
1111746|NCT00535405|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
1111747|NCT00535405|O4|Outcome|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
1111748|NCT00535405|O3|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
1111749|NCT00535405|O2|Outcome|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
1111754|NCT00535405|E2|Reported Event|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
1111755|NCT00535405|E1|Reported Event|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
1111756|NCT00535392|B1|Baseline|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.~Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily)."
1111757|NCT00535392|P1|Participant Flow|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.~Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily)."
1111758|NCT00535392|O1|Outcome|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.~Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily)."
1111759|NCT00535392|O1|Outcome|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.~Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily)."
1111760|NCT00535392|O1|Outcome|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.~Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily)."
1111761|NCT00535392|E1|Reported Event|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.~Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily)."
1111762|NCT00535301|B3|Baseline|Total|Total of all reporting groups
1111763|NCT00535301|B2|Baseline|Perigee|Anterior vaginal prolapse repair with graft
1111764|NCT00535301|B1|Baseline|Anterior Colporrhaphy|Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
1111765|NCT00535301|P2|Participant Flow|Perigee|Anterior vaginal prolapse repair with graft
1111766|NCT00535301|P1|Participant Flow|Anterior Colporrhaphy|Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
1111767|NCT00535301|O2|Outcome|Perigee|Anterior vaginal prolapse repair with graft
1111768|NCT00535301|O1|Outcome|Anterior Colporrhaphy|Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
1111769|NCT00535301|O2|Outcome|Perigee (Grafted Repair)|Anterior vaginal prolapse repair with graft
1111770|NCT00535301|O1|Outcome|Anterior Colporrhaphy (Sutured Repair)|Sutured anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
1111771|NCT00535301|O2|Outcome|Perigee|Anterior vaginal prolapse repair with graft
1111772|NCT00535301|O1|Outcome|Anterior Colporrhaphy|Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
1111773|NCT00535301|E2|Reported Event|Perigee|Anterior vaginal prolapse repair with graft
1111774|NCT00535301|E1|Reported Event|Anterior Colporrhaphy|Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
1111775|NCT00535288|B6|Baseline|Total|Total of all reporting groups
1111776|NCT00535288|B5|Baseline|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111777|NCT00535288|B4|Baseline|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111778|NCT00535288|B3|Baseline|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111779|NCT00535288|B2|Baseline|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111780|NCT00535288|B1|Baseline|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
1111781|NCT00535288|P5|Participant Flow|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111782|NCT00535288|P4|Participant Flow|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111783|NCT00535288|P3|Participant Flow|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111784|NCT00535288|P2|Participant Flow|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111785|NCT00535288|P1|Participant Flow|Placebo|Participants receive encapsulated tablets, orally, once daily (QD) for up to 12 weeks.
1111786|NCT00535288|O5|Outcome|Esmirtazapine 18mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111787|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally, QD for up to 12 weeks
1111788|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111789|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111790|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
1111791|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111792|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally, QD for up to 12 weeks
1114327|NCT00529542|E2|Reported Event|Placebo|Placebo qd
1111793|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111794|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111795|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, once daily QD for up to 12 weeks.
1111796|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111797|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111798|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111799|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111800|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
1111801|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111802|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111803|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111804|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111805|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
1111806|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
1111807|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111808|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111809|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111810|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
1111811|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
1111812|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111813|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111814|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111815|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
1111816|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
1111817|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111818|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111819|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111820|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
1111821|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
1111822|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111823|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111824|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111825|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
1111826|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
1111827|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111828|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111829|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111830|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
1111831|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
1111832|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111833|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111834|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111835|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
1111836|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
1111837|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111838|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111839|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111840|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
1112130|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
1111841|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
1111842|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111843|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111844|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111845|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, once daily QD for up to 12 weeks.
1111846|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
1111847|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111848|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111849|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111850|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
1111851|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
1111852|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111853|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111854|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111855|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, once daily (QD) for up to 12 weeks.
1111856|NCT00535288|E5|Reported Event|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111857|NCT00535288|E4|Reported Event|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111858|NCT00535288|E3|Reported Event|Esmertazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111859|NCT00535288|E2|Reported Event|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
1111860|NCT00535288|E1|Reported Event|Placebo|Participants receive encapsulated tablets, orally, once daily (QD) for up to 12 weeks.
1111861|NCT00535262|B1|Baseline|Open EmSam|8-week open-label treatment with EmSam
1111862|NCT00535262|P1|Participant Flow|EmSam|"EmSam will be administered in open-label fashion for 8-weeks during phase I of the study during which symptoms of depression will be assessed weekly. Those whose depression responds after 8-weeks will be entered into an 8-month open-label continuation phase during which they will be maintained on EmSam and be assessed on a monthly basis.~EmSam : Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch"
1111863|NCT00535262|O1|Outcome|EmSam|"EmSam was administered in open-label fashion during phase I of the study during which symptoms of depression were assessed weekly. The study was terminated early so the data are not reported.~EmSam : Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch"
1111946|NCT00535002|B2|Baseline|Cocaine Females, Placebo Then Yohimbine|Cocaine-dependent females, received placebo day 1, yohimbine day 2
1112775|NCT00532779|E1|Reported Event|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
1111864|NCT00535262|E1|Reported Event|EmSam|"EmSam will be administered in open-label fashion for 8-weeks during phase I of the study during which symptoms of depression will be assessed weekly. Those whose depression responds after 8-weeks will be entered into an 8-month open-label continuation phase during which they will be maintained on EmSam and be assessed on a monthly basis.~EmSam : Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch"
1111865|NCT00535223|B3|Baseline|Total|Total of all reporting groups
1111866|NCT00535223|B2|Baseline|Present Centered Group Therapy|"Present Centered Group Therapy: Present Centered Group Therapy includes psych-education about PTSD and a problem solving here and now focus."
1111867|NCT00535223|B1|Baseline|Group Based Exposure Therapy|Group Based Exposure Therapy: GBET is a 16-week program during which patients attend group therapy twice a week for three hours of group per day and are required to make two war trauma presentations to their group. These are recorded and the patients are required to listen to these recordings a minimum of 10 times. There are generally 10 patients per group and through the combination of making their own presentations, listening to recordings of these presentations, and hearing the presentations of the other nine group members, there are over 60 hours of exposure. Patients also learn about PTSD symptoms, sleep hygiene, specific stress/anger management techniques, and ways to cognitively restructure trauma-related thinking.
1111868|NCT00535223|P2|Participant Flow|Present Centered Group Therapy|"Present Centered Group Therapy: Present Centered Group Therapy includes psych-education about PTSD and a problem solving here and now focus."
1111869|NCT00535223|P1|Participant Flow|Group Based Exposure Therapy|Group Based Exposure Therapy: GBET is a 16-week program during which patients attend group therapy twice a week for three hours of group per day and are required to make two war trauma presentations to their group. These are recorded and the patients are required to listen to these recordings a minimum of 10 times. There are generally 10 patients per group and through the combination of making their own presentations, listening to recordings of these presentations, and hearing the presentations of the other nine group members, there are over 60 hours of exposure. Patients also learn about PTSD symptoms, sleep hygiene, specific stress/anger management techniques, and ways to cognitively restructure trauma-related thinking.
1111870|NCT00535223|O2|Outcome|Present Centered Group Therapy|The group met twice a week for 16 weeks for 90 minutes per session. The focus was on dealing with problem solving in the here and now while avoiding traumatic material.
1111894|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
1111895|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
1111871|NCT00535223|O1|Outcome|Group Based Exposure Therapy|"See below~Group Based Exposure Therapy: GBET is a 16-week program during which patients attend group therapy twice a week for three hours of group per day and are required to make two war trauma presentations to their group. These are recorded and the patients are required to listen to these recordings a minimum of 10 times. There are generally 10 patients per group and through the combination of making their own presentations, listening to recordings of these presentations, and hearing the presentations of the other nine group members, there are over 60 hours of exposure. Patients also learn about PTSD symptoms, sleep hygiene, specific stress/anger management techniques, and ways to cognitively restructure trauma-related thinking."
1111872|NCT00535223|O2|Outcome|Present Centered Group Therapy|The group met twice a week for 16 weeks for 90 minutes per session. The focus was on dealing with problem solving in the here and now while avoiding traumatic material.
1111873|NCT00535223|O1|Outcome|Group Based Exposure Therapy|"See below~Group Based Exposure Therapy: GBET is a 16-week program during which patients attend group therapy twice a week for three hours of group per day and are required to make two war trauma presentations to their group. These are recorded and the patients are required to listen to these recordings a minimum of 10 times. There are generally 10 patients per group and through the combination of making their own presentations, listening to recordings of these presentations, and hearing the presentations of the other nine group members, there are over 60 hours of exposure. Patients also learn about PTSD symptoms, sleep hygiene, specific stress/anger management techniques, and ways to cognitively restructure trauma-related thinking."
1111874|NCT00535223|E2|Reported Event|Present Centered Group Therapy|Present Centered Group Therapy. No serious adverse events occurred in response to this treatment.
1111875|NCT00535223|E1|Reported Event|Group Based Exposure Therapy|Group Based Exposure Therapy. No serious adverse events occurred in response to this treatment.
1111876|NCT00535145|B1|Baseline|Study Treatment|Phase 1; Day 1 through Day 27: Patients took therapy for schizophrenia as prescribed before study entry (referred to “treatment as usual” abbreviated as “TAU”) for 4 weeks. Phase 2; Day 28 through Day 62: The dose of TAU was then tapered (reduced and stopped) over a 1-week period and treatment started with paliperidone extended-release (ER) tablets, 6 mg, orally (by mouth) once daily followed by 4 weeks of paliperidone ER, 3-12 mg once daily as monotherapy (treatment with Paliperidone ER alone).
1111877|NCT00535145|P1|Participant Flow|Study Treatment|Phase 1; Day 1 through Day 27: Patients took therapy for schizophrenia as prescribed before study entry (referred to “treatment as usual” abbreviated as “TAU”) for 4 weeks. Phase 2; Day 28 through Day 62: The dose of TAU was then tapered (reduced and stopped) over a 1-week period and treatment started with paliperidone extended-release (ER) tablets, 6 mg, orally (by mouth) once daily followed by 4 weeks of paliperidone ER, 3-12 mg once daily as monotherapy (treatment with Paliperidone ER alone)
1111878|NCT00535145|O2|Outcome|Paliperidone ER Phase|Day 28 through Day 62 (1 week cross titration plus 4 weeks mono-therapy).
1111879|NCT00535145|O1|Outcome|TAU Phase|Day 1 through Day 27 (4 weeks)
1111880|NCT00535145|O1|Outcome|Study Treatment|Day 1 through Day 27: Antipsychotic treatment as usual (TAU); Day 28 through Day 62: Paliperidone ER (1 week cross titration plus 4 weeks mono-therapy).
1111881|NCT00535145|O1|Outcome|Study Treatment|Day 1 through Day 27: Antipsychotic treatment as usual (TAU); Day 28 through Day 62: Paliperidone ER (1 week cross titration plus 4 weeks mono-therapy).
1111882|NCT00535145|O1|Outcome|Study Treatment|Day 1 through Day 27: Antipsychotic treatment as usual (TAU); Day 28 through Day 62: Paliperidone ER (1 week cross titration plus 4 weeks mono-therapy).
1111883|NCT00535145|E3|Reported Event|TAU - All Enrolled Participants|Phase 1; Day 1 through Day 27: Patients took therapy for schizophrenia as prescribed before study entry (referred to “treatment as usual” abbreviated as “TAU”) for 4 weeks. Phase 2; Day 28 through Day 62: The dose of TAU was then tapered (reduced and stopped) over a 1-week period and treatment started with paliperidone extended-release (ER) tablets, 6 mg, orally (by mouth) once daily followed by 4 weeks of paliperidone ER, 3-12 mg once daily as monotherapy (treatment with Paliperidone ER alone).
1112776|NCT00532493|B3|Baseline|Total|Total of all reporting groups
1111884|NCT00535145|E2|Reported Event|Paliperidone ER Phase|Phase 2; Day 28 through Day 62: The dose of TAU was then tapered (reduced and stopped) over a 1-week period and treatment started with paliperidone extended-release (ER) tablets, 6 mg, orally (by mouth) once daily followed by 4 weeks of paliperidone ER, 3-12 mg once daily as monotherapy (treatment with Paliperidone ER alone).
1111885|NCT00535145|E1|Reported Event|TAU - Pali ER|Phase 1; Day 1 through Day 27: Patients took therapy for schizophrenia as prescribed before study entry (referred to “treatment as usual” abbreviated as “TAU”) for 4 weeks who went on to participate in Phase 2 (Paliperidone ER Phase).
1111886|NCT00535132|B3|Baseline|Total|Total of all reporting groups
1111887|NCT00535132|B2|Baseline|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were then to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
1111888|NCT00535132|B1|Baseline|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
1111889|NCT00535132|P2|Participant Flow|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
1111890|NCT00535132|P1|Participant Flow|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
1111891|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
1111892|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
1111893|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
1112131|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
1111896|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
1111897|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
1111898|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
1111899|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
1111900|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
1111901|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
1111902|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
1111903|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
1111904|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
1111905|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
1111906|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
1111907|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
1111908|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
1111909|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
1111910|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
1111911|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
1111912|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
1111947|NCT00535002|B1|Baseline|Cocaine Females, Yohimbine Then Placebo|Cocaine-dependent females, received yohimbine day 1, placebo day 2
1113808|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1111913|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
1111914|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
1111915|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
1111916|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
1111917|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
1111918|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
1111919|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
1111920|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
1111921|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
1111922|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
1111923|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
1111924|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
1112022|NCT00534105|E1|Reported Event|Gestational Diabetics|Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.
1111925|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
1111926|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
1111927|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
1111928|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
1111929|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
1111930|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
1111931|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
1111932|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
1111933|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
1111934|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
1111935|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
1111936|NCT00535132|E3|Reported Event|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
1111937|NCT00535132|E2|Reported Event|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
1111938|NCT00535132|E1|Reported Event|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
1111939|NCT00535002|B9|Baseline|Total|Total of all reporting groups
1111940|NCT00535002|B8|Baseline|Control Males, Placebo Then Yohimbine|non-dependent males, received placebo day and yohimbine day 2
1111941|NCT00535002|B7|Baseline|Control Males, Yohimbine Then Placebo|non-dependent males, received yohimbine day and placebo day 2
1111942|NCT00535002|B6|Baseline|Control Females, Placebo Then Yohimbine|non-dependent females, received placebo day and yohimbine day 2
1111943|NCT00535002|B5|Baseline|Control Females, Yohimbine Then Placebo|non-dependent females, received yohimbine day and placebo day 2
1111944|NCT00535002|B4|Baseline|Cocaine Males, Placebo Then Yohimbine|Cocaine-dependent males, received placebo day 1, yohimbine day 2
1111945|NCT00535002|B3|Baseline|Cocaine Males, Yohimbine Then Placebo|Cocaine-dependent males, received yohimbine day 1, placebo day 2
1111948|NCT00535002|P8|Participant Flow|Control Males, Placebo Then Yohimbine|Non-dependent males, placebo then yohimbine
1111949|NCT00535002|P7|Participant Flow|Control Females, Placebo Then Yohimbine|Non-dependent females, placebo then yohimbine
1111950|NCT00535002|P6|Participant Flow|Cocaine Males, Placebo Then Yohimbine|Cocaine-dependent males, Placebo then Yohimbine
1111951|NCT00535002|P5|Participant Flow|Cocaine Females, Placebo Then Yohimbine|Cocaine females-dependent females, Placebo then yohimbine
1111952|NCT00535002|P4|Participant Flow|Control Males, Yohimbine Then Placebo|Non-dependent males, Yohimbine then placebo
1111953|NCT00535002|P3|Participant Flow|Control Females, Yohimbine Then Placebo|Non-dependent females, Yohimbine then placebo
1111954|NCT00535002|P2|Participant Flow|Cocaine Males, Yohimbine Then Placebo|Cocaine-dependent males, Yohimbine then placebo
1111955|NCT00535002|P1|Participant Flow|Cocaine Females, Yohimbine Then Placebo|Cocaine-dependent females, Yohimbine then placebo
1111956|NCT00535002|O8|Outcome|Control Males Placebo|
1111957|NCT00535002|O7|Outcome|Control Males Yohimbine|
1111958|NCT00535002|O6|Outcome|Control Females Placebo|
1111959|NCT00535002|O5|Outcome|Control Females Yohimbine|
1111960|NCT00535002|O4|Outcome|Cocaine Males Placebo|Cocaine-dependent males pre-treated with placebo
1111961|NCT00535002|O3|Outcome|Cocaine Males Yohimbine|Cocaine-dependent males pre-treated with yohimbine
1111962|NCT00535002|O2|Outcome|Cocaine Females Placebo|Cocaine-dependent females pre-treated with placebo
1111963|NCT00535002|O1|Outcome|Cocaine Females Yohimbine|Cocaine-dependent females pre-treated with yohimbine
1111964|NCT00535002|E4|Reported Event|Control Males|Non-dependent males
1111965|NCT00535002|E3|Reported Event|Control Females|Non-dependent females
1111966|NCT00535002|E2|Reported Event|Cocaine Males|Cocaine-dependent males
1111967|NCT00535002|E1|Reported Event|Cocaine Females|Cocaine-dependent females
1111968|NCT00534976|B3|Baseline|Total|Total of all reporting groups
1111983|NCT00534976|O2|Outcome|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
1112023|NCT00534092|B3|Baseline|Total|Total of all reporting groups
1114328|NCT00529542|E1|Reported Event|Atorvastatin|Atorvastatin, 40 mg qd
1111969|NCT00534976|B2|Baseline|Placebo/ Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. In Period II, participants 4-5 years of age were randomized to receive one placebo 4-mg chewable tablet (single dose). Period III was the crossover to one Montelukast 4-mg chewable tablet (single dose) after a 3- to 7-day washout period. No participants 4-5 years of age were randomized, so the 4-mg doses were not dispensed. Participants 6-14 years of age were randomized to receive one placebo 5-mg chewable tablet (single dose) in Period II, crossing over to one Montelukast 5-mg chewable tablet (single dose) in Period III after a 3- to 7-day washout period.
1111970|NCT00534976|B1|Baseline|Montelukast/ Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. In Period II, participants 4-5 years of age were randomized to receive one Montelukast 4-mg chewable tablet (single dose). Period III was the crossover to one matching placebo 4-mg chewable tablet (single dose) after a 3- to 7-day washout period. No participants 4-5 years of age were randomized, so the 4-mg doses were not dispensed. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II, crossing over to one matching placebo 5-mg chewable tablet (single dose) in Period III after a 3- to 7-day washout period.
1111971|NCT00534976|P2|Participant Flow|Placebo/ Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. In Period II, participants 4-5 years of age were randomized to receive one placebo 4-mg chewable tablet (single dose). Period III was the crossover to one Montelukast 4-mg chewable tablet (single dose) after a 3- to 7-day washout period. No participants 4-5 years of age were randomized, so the 4-mg doses were not dispensed. Participants 6-14 years of age were randomized to receive one placebo 5-mg chewable tablet (single dose) in Period II, crossing over to one Montelukast 5-mg chewable tablet (single dose) in Period III after a 3- to 7-day washout period.
1111972|NCT00534976|P1|Participant Flow|Montelukast/ Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. In Period II, participants 4-5 years of age were randomized to receive one Montelukast 4-mg chewable tablet (single dose). Period III was the crossover to one matching placebo 4-mg chewable tablet (single dose) after a 3- to 7-day washout period. No participants 4-5 years of age were randomized, so the 4-mg doses were not dispensed. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II, crossing over to one matching placebo 5-mg chewable tablet (single dose) in Period III after a 3- to 7-day washout period.
1111973|NCT00534976|O2|Outcome|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
1111974|NCT00534976|O1|Outcome|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
1111975|NCT00534976|O2|Outcome|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
1111976|NCT00534976|O1|Outcome|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
1111977|NCT00534976|O2|Outcome|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
1112271|NCT00534352|O1|Outcome|Treatment A: TMC125 + TDF/FTC|Treatment A: TMC125 + TDF/FTC.
1111978|NCT00534976|O1|Outcome|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
1111979|NCT00534976|O2|Outcome|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
1111980|NCT00534976|O1|Outcome|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
1111981|NCT00534976|O2|Outcome|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
1111982|NCT00534976|O1|Outcome|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
1112020|NCT00534105|O1|Outcome|Gestational Diabetics|Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.
1112021|NCT00534105|E2|Reported Event|Normal Pregnancies|Normal pregnant women without gestational diabetes
1111984|NCT00534976|O1|Outcome|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
1111985|NCT00534976|O2|Outcome|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
1111986|NCT00534976|O1|Outcome|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
1111987|NCT00534976|O2|Outcome|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
1111988|NCT00534976|O1|Outcome|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
1111989|NCT00534976|E2|Reported Event|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
1111990|NCT00534976|E1|Reported Event|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
1111991|NCT00534248|B3|Baseline|Total|Total of all reporting groups
1111992|NCT00534248|B2|Baseline|Placebo|Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
1111993|NCT00534248|B1|Baseline|Zostavax™|Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).
1111994|NCT00534248|P2|Participant Flow|Placebo|Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
1111995|NCT00534248|P1|Participant Flow|Zostavax™|Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).
1111996|NCT00534248|O2|Outcome|Placebo|Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
1111997|NCT00534248|O1|Outcome|Zostavax™|Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).
1111998|NCT00534248|O2|Outcome|Placebo|Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
1111999|NCT00534248|O1|Outcome|Zostavax™|Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).
1112000|NCT00534248|O2|Outcome|Placebo|Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
1112001|NCT00534248|O1|Outcome|Zostavax™|Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).
1112002|NCT00534248|E2|Reported Event|Placebo|Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
1112272|NCT00534352|E4|Reported Event|Optional Extension|DRV/rtv + TDF/FTC
1112003|NCT00534248|E1|Reported Event|Zostavax™|Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).
1112004|NCT00534209|B1|Baseline|Arm I|"Patients will receive B7 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.~Given intradermally."
1112005|NCT00534209|P1|Participant Flow|Arm I|"Patients will receive B7 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.~Given intradermally."
1112006|NCT00534209|O1|Outcome|Arm I|"Patients will receive B7 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.~Given intradermally."
1112007|NCT00534209|E1|Reported Event|Arm I|"Patients will receive B7 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.~Given intradermally."
1112008|NCT00534105|B3|Baseline|Total|Total of all reporting groups
1112009|NCT00534105|B2|Baseline|Normal Pregnancies|Normal pregnant women without gestational diabetes
1112010|NCT00534105|B1|Baseline|Gestational Diabetics|Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.
1112011|NCT00534105|P2|Participant Flow|Normal Pregnancies|Normal pregnant women without gestational diabetes
1112012|NCT00534105|P1|Participant Flow|Gestational Diabetics|Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.
1112013|NCT00534105|O2|Outcome|Normal Pregnancies|Normal pregnant women without gestational diabetes
1112014|NCT00534105|O1|Outcome|Gestational Diabetics|Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.
1112015|NCT00534105|O2|Outcome|Normal Pregnancies|Normal pregnant women without gestational diabetes
1112016|NCT00534105|O1|Outcome|Gestational Diabetics|Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.
1112017|NCT00534105|O2|Outcome|Normal Pregnancies|Normal pregnant women without gestational diabetes
1112018|NCT00534105|O1|Outcome|Gestational Diabetics|Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.
1112019|NCT00534105|O2|Outcome|Normal Pregnancies|Normal pregnant women without gestational diabetes
1112024|NCT00534092|B2|Baseline|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
1112025|NCT00534092|B1|Baseline|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
1112026|NCT00534092|P2|Participant Flow|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
1112027|NCT00534092|P1|Participant Flow|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
1112028|NCT00534092|O3|Outcome|Total|Total patients included target group and safety group.
1112029|NCT00534092|O2|Outcome|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
1112030|NCT00534092|O1|Outcome|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
1112031|NCT00534092|O3|Outcome|Total|Total patients included target group and safety group.
1112032|NCT00534092|O2|Outcome|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
1112033|NCT00534092|O1|Outcome|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
1112034|NCT00534092|O3|Outcome|Total|Total patients included target group and safety group.
1112035|NCT00534092|O2|Outcome|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
1112036|NCT00534092|O1|Outcome|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
1112037|NCT00534092|O3|Outcome|Total|Total patients included target group and safety group.
1112038|NCT00534092|O2|Outcome|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
1112039|NCT00534092|O1|Outcome|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
1112040|NCT00534092|O3|Outcome|Total|Total patients included target group and safety group.
1112041|NCT00534092|O2|Outcome|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
1112042|NCT00534092|O1|Outcome|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
1112043|NCT00534092|O3|Outcome|Total|Total patients included target group and safety group.
1112044|NCT00534092|O2|Outcome|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
1112045|NCT00534092|O1|Outcome|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
1112046|NCT00534092|E3|Reported Event|Total|Total patients included target group and safety group.
1112047|NCT00534092|E2|Reported Event|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
1112048|NCT00534092|E1|Reported Event|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
1112049|NCT00534937|B3|Baseline|Total|Total of all reporting groups
1112050|NCT00534937|B2|Baseline|Flexitouch|Patients in this arm will receive once-a-week short stretch compression wrapping AND once daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
1112051|NCT00534937|B1|Baseline|Standard Compression|Patients in this arm will receive current standard of care (once weekly short-stretch compression wrapping).
1112052|NCT00534937|P2|Participant Flow|Flexitouch|Patients in this arm will receive once-a-week short stretch compression wrapping AND once daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
1112053|NCT00534937|P1|Participant Flow|Standard Compression|Patients in this arm will receive current standard of care (once-weekly short-stretch compression wrapping).
1112054|NCT00534937|O2|Outcome|Flexitouch|Patients in this arm received once-a-week short stretch compression wrapping AND once-daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
1112055|NCT00534937|O1|Outcome|Standard Compression|Patients in this arm received current standard of care (once-weekly short-stretch compression wrapping).
1112056|NCT00534937|O2|Outcome|Flexitouch|Patients in this arm received once-a-week short stretch compression wrapping AND once-daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
1112057|NCT00534937|O1|Outcome|Standard Compression|Patients in this arm received current standard of care (once weekly short-stretch compression wrapping).
1112058|NCT00534937|O2|Outcome|Flexitouch|Patients in this arm received once-a-week short stretch compression wrapping AND once daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
1112059|NCT00534937|O1|Outcome|Standard Compression|Patients in this arm received current standard of care (once weekly short-stretch compression wrapping).
1112060|NCT00534937|O2|Outcome|Flexitouch|Patients in this arm received once-a-week short stretch compression wrapping AND once-daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
1112061|NCT00534937|O1|Outcome|Standard Compression|Patients in this arm received current standard of care (once weekly short-stretch compression wrapping).
1112062|NCT00534937|E2|Reported Event|Flexitouch|Patients in this arm will receive once-a-week short stretch compression wrapping AND once daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
1112063|NCT00534937|E1|Reported Event|Standard Compression|Patients in this arm will receive current standard of care (once weekly short-stretch compression wrapping).
1112064|NCT00534833|B3|Baseline|Total|Total of all reporting groups
1112065|NCT00534833|B2|Baseline|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
1112066|NCT00534833|B1|Baseline|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of DTaP-Hep B-PRP-T concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP-T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
1112067|NCT00534833|P2|Participant Flow|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with OPV at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
1112068|NCT00534833|P1|Participant Flow|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of DTaP-Hep B-PRP~T concomitantly with OPV at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP~T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
1112069|NCT00534833|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
1112070|NCT00534833|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of DTaP-Hep B-PRP-T concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP-T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
1112071|NCT00534833|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
1112072|NCT00534833|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of DTaP-Hep B-PRP-T concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP-T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
1112073|NCT00534833|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine following a 3-dose primary series of Tritanrix-Hep B/ Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL203
1112074|NCT00534833|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL203.
1112075|NCT00534833|E2|Reported Event|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
1112273|NCT00534352|E3|Reported Event|Treatment C|DRV/rtv + TDF/FTC
1112076|NCT00534833|E1|Reported Event|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of DTaP-Hep B-PRP-T concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP-T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
1112077|NCT00534794|B3|Baseline|Total|Total of all reporting groups
1112078|NCT00534794|B2|Baseline|Pataday|1 drop each eye for 1 day
1112079|NCT00534794|B1|Baseline|Elestat|1 drop each eye for 2 days
1112080|NCT00534794|P2|Participant Flow|Pataday|1 drop each eye for 1 day
1112081|NCT00534794|P1|Participant Flow|Elestat|1 drop each eye for 2 days
1112082|NCT00534794|O2|Outcome|Pataday|1 drop each eye for 1 day
1112083|NCT00534794|O1|Outcome|Elestat|1 drop each eye for 2 days
1112084|NCT00534794|O2|Outcome|Pataday|1 drop each eye for 1 day
1112085|NCT00534794|O1|Outcome|Elestat|1 drop each eye for 2 days
1112086|NCT00534794|E2|Reported Event|Pataday|1 drop each eye for 1 day
1112087|NCT00534794|E1|Reported Event|Elestat|1 drop each eye for 2 days
1112088|NCT00534638|B3|Baseline|Total|Total of all reporting groups
1112089|NCT00534638|B2|Baseline|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112090|NCT00534638|B1|Baseline|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112091|NCT00534638|P2|Participant Flow|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112092|NCT00534638|P1|Participant Flow|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112093|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112094|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112095|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112096|NCT00534638|O1|Outcome|Cervarix Pooled Group|Female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112097|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112098|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112099|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112100|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112101|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112102|NCT00534638|O1|Outcome|Cervarix Pooled Group|male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112103|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112104|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112105|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112106|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112107|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112108|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112109|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112110|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112111|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112112|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112113|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112114|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112115|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112116|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112117|NCT00534638|O2|Outcome|Cervarix/Engerix-B Pooled Group|Male and female subjects receiving Cervarix™/Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112118|NCT00534638|O1|Outcome|No-vaccine Group|Subjects who were enrolled but not vaccinated.
1112119|NCT00534638|O3|Outcome|Engerix-B Group|All adolescents were vaccinated with Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112120|NCT00534638|O2|Outcome|Cervarix/Engerix-B B Group|90% of the female adolescents received Cervarix™ vaccine. Male adolescents and rest of the female adolescents received Engerix™-B vaccine. Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112121|NCT00534638|O1|Outcome|Cervarix/Engerix-B A Group|90% of male and female adolescents received Cervarix™ vaccine. Rest of the subjects received Engerix™-B vaccine. Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112122|NCT00534638|E2|Reported Event|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112123|NCT00534638|E1|Reported Event|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
1112124|NCT00534599|B3|Baseline|Total|Total of all reporting groups
1112125|NCT00534599|B2|Baseline|Placebo|Matching placebo tablets once daily
1112126|NCT00534599|B1|Baseline|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
1112127|NCT00534599|P2|Participant Flow|Placebo|Matching placebo tablets once daily
1112132|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
1112133|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
1112134|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
1112135|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
1112136|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
1112137|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
1112138|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
1112139|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
1112140|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
1112141|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
1112142|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
1112143|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
1112144|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
1112145|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
1112146|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
1112147|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
1112148|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
1112149|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
1112150|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
1112151|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
1112152|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
1112153|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
1112154|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
1112155|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
1112156|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
1112157|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
1112158|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
1112159|NCT00534599|E2|Reported Event|Placebo|Matching placebo tablets once daily
1112160|NCT00534599|E1|Reported Event|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
1112161|NCT00534495|B3|Baseline|Total|Total of all reporting groups
1112162|NCT00534495|B2|Baseline|Placebo|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
1112163|NCT00534495|B1|Baseline|Rilonacept|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
1112164|NCT00534495|P3|Participant Flow|Long Term Extension All Participants|All participants who benefited from rilonacept were eligible to enroll this phase and receive rilonacept 2.2mg/kg weekly
1112274|NCT00534352|E2|Reported Event|Treatment B|TMC125 + TDF/FTC + DRV/rtv
1112165|NCT00534495|P2|Participant Flow|Placebo|"Placebo loading dose followed by maintenance dose for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the long term extension~Rilonacept: 2.2 mg/kg subcutaneously"
1112166|NCT00534495|P1|Participant Flow|Rilonacept|Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week followed by a placebo loading dose and then rilonacept in the long term extension phase Rilonacept: 2.2 mg/kg subcutaneously
1112167|NCT00534495|O3|Outcome|Long Term Extension 24 Weeks to 21 Months|
1112168|NCT00534495|O2|Outcome|Placebo|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
1112169|NCT00534495|O1|Outcome|Rilonacept|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
1112170|NCT00534495|O3|Outcome|Week 24- All Subjects|
1112171|NCT00534495|O2|Outcome|Placebo|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
1112172|NCT00534495|O1|Outcome|Rilonacept|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
1112173|NCT00534495|O3|Outcome|Week 24- All Subjects|
1112174|NCT00534495|O2|Outcome|Placebo|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
1112175|NCT00534495|O1|Outcome|Rilonacept|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
1112176|NCT00534495|O3|Outcome|Week 24- All Subjects|
1112177|NCT00534495|O2|Outcome|Placebo|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
1112178|NCT00534495|O1|Outcome|Rilonacept|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
1112179|NCT00534495|O2|Outcome|Placebo|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
1112180|NCT00534495|O1|Outcome|Rilonacept|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
1112181|NCT00534495|O2|Outcome|Placebo|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
1112182|NCT00534495|O1|Outcome|Rilonacept|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
1112183|NCT00534495|E5|Reported Event|Long Term Extension 24 Weeks to 21 Months|
1114329|NCT00529529|B4|Baseline|Total|Total of all reporting groups
1112184|NCT00534495|E4|Reported Event|Placebo Week (4-24)|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
1112185|NCT00534495|E3|Reported Event|Rilonacept Week (4-24)|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
1112186|NCT00534495|E2|Reported Event|Placebo Week (0-4)|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
1112187|NCT00534495|E1|Reported Event|Rilonacept Week (0-4)|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
1112188|NCT00534417|B1|Baseline|Treatment Group: Capecitabine/Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
1112189|NCT00534417|P1|Participant Flow|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg orally (po) in the morning (AM) and 500 mg po in the evening (PM) in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
1112190|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
1112191|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
1112192|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
1112193|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
1112194|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
1112195|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
1112196|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
1112197|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
1112198|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
1112199|NCT00534417|E1|Reported Event|Treatment Group: Capecitabine/Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
1112200|NCT00534404|B4|Baseline|Total|Total of all reporting groups
1112201|NCT00534404|B3|Baseline|Internet|"Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
1112202|NCT00534404|B2|Baseline|Nicotine Patches and Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
1112283|NCT00534313|P2|Participant Flow|Abatacept 10/10|Participants were administered iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
1112508|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
1112203|NCT00534404|B1|Baseline|NRT Patch, Phone Counseling, Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~Telephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
1112204|NCT00534404|P3|Participant Flow|Internet|"Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
1112205|NCT00534404|P2|Participant Flow|Nicotine Patches and Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
1112206|NCT00534404|P1|Participant Flow|NRT Patch, Phone Counseling, Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~Telephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
1112207|NCT00534404|O3|Outcome|Internet|"Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
1112208|NCT00534404|O2|Outcome|Nicotine Patches and Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
1112209|NCT00534404|O1|Outcome|NRT Patch, Phone Counseling, Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~Telephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
1112210|NCT00534404|O3|Outcome|Internet|"Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
1112211|NCT00534404|O2|Outcome|Nicotine Patches and Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
1112275|NCT00534352|E1|Reported Event|Treatment A|TMC125 + TDF/FTC
1112212|NCT00534404|O1|Outcome|NRT Patch, Phone Counseling, Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~Telephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
1112213|NCT00534404|O3|Outcome|Internet|"Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
1112214|NCT00534404|O2|Outcome|Nicotine Patches and Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
1112215|NCT00534404|O1|Outcome|NRT Patch, Phone Counseling, Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~Telephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
1112216|NCT00534404|E3|Reported Event|Internet|"Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
1112217|NCT00534404|E2|Reported Event|Nicotine Patches and Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
1112218|NCT00534404|E1|Reported Event|NRT Patch, Phone Counseling, Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~Telephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
1112219|NCT00534365|B3|Baseline|Total|Total of all reporting groups
1112220|NCT00534365|B2|Baseline|TVT-SECUR Mini Sling Procedure|"TVT-SECUR device~TVT-SECUR device: Mid-urethral mini-sling"
1112221|NCT00534365|B1|Baseline|TVT Procedure|"Tension-free vaginal tape procedure (TVT)~tension-free vaginal tape: Retropubic mid-urethral sling"
1112222|NCT00534365|P2|Participant Flow|TVT-SECUR Mini Sling Procedure|"TVT-SECUR device~TVT-SECUR device: Mid-urethral mini-sling"
1112223|NCT00534365|P1|Participant Flow|TVT Procedure|"Tension-free vaginal tape procedure (TVT)~tension-free vaginal tape: Retropubic mid-urethral sling"
1112224|NCT00534365|O2|Outcome|TVT Procedure|"Tension-free vaginal tape procedure (TVT)~tension-free vaginal tape: Retropubic mid-urethral sling"
1112225|NCT00534365|O1|Outcome|TVT-SECUR Mini Sling Procedure|"TVT-SECUR device~TVT-SECUR device: Mid-urethral mini-sling"
1112226|NCT00534365|O2|Outcome|TVT Procedure|"Tension-free vaginal tape procedure (TVT)~tension-free vaginal tape: Retropubic mid-urethral sling"
1112227|NCT00534365|O1|Outcome|TVT-SECUR Mini Sling Procedure|"TVT-SECUR device~TVT-SECUR device: Mid-urethral mini-sling"
1112228|NCT00534365|O2|Outcome|TVT Procedure|"Tension-free vaginal tape procedure (TVT)~tension-free vaginal tape: Retropubic mid-urethral sling"
1112229|NCT00534365|O1|Outcome|TVT-SECUR Mini Sling Procedure|"TVT-SECUR device~TVT-SECUR device: Mid-urethral mini-sling"
1112230|NCT00534365|O2|Outcome|TVT Procedure|"Tension-free vaginal tape procedure (TVT)~tension-free vaginal tape: Retropubic mid-urethral sling"
1112231|NCT00534365|O1|Outcome|TVT-SECUR Mini Sling Procedure|"TVT-SECUR device~TVT-SECUR device: Mid-urethral mini-sling"
1112232|NCT00534365|O2|Outcome|TVT-SECUR Mini Sling Procedure|"TVT-SECUR device~TVT-SECUR device: Mid-urethral mini-sling"
1112233|NCT00534365|O1|Outcome|TVT Procedure|"Tension-free vaginal tape procedure (TVT)~tension-free vaginal tape: Retropubic mid-urethral sling"
1112234|NCT00534365|E2|Reported Event|TVT Procedure|"Tension-free vaginal tape procedure (TVT)~tension-free vaginal tape: Retropubic mid-urethral sling"
1112235|NCT00534365|E1|Reported Event|TVT-SECUR Mini Sling Procedure|"TVT-SECUR device~TVT-SECUR device: Mid-urethral mini-sling"
1112236|NCT00534352|B1|Baseline|TDF/FTC +/- TMC125 +/- DRV/Rtv|"In the first part of the trial (Days 1-14), all subjects received TMC125 400 mg once daily (qd) in combination with fixed dose combinations (FDC) of tenofovir disoproxil (TDF)/emtricitabine (FTC) 300/200 mg qd(Truvada®) for 14 days (Treatment A: TMC125 + TDF/FTC ). On Day 14, 24-hour intensive TMC125 pharmacokinetic sampling took place and fasting lipids were assessed.~In the second part of the trial (Days 15-28) darunavir (DRV)/ritonavir (rtv) 800/100 mg qd was added to the regimen (Treatment B: TMC 125 + TDF/FTC + DRV/rtv). On Day 28, 24-hour intensive pharmacokinetic sampling for TMC125, DRV and ritonavir took place and fasting lipids were assessed.~In the third part of the trial (Day 29-42), TMC125 was discontinued and subjects received treatment with DRV/rtv 800/100 mg q.d. and TDF/FTC FDC 300/200 mg qd (Treatment C: DRV/rtv + TDF/FTC).On Day 42, fasting lipids were assessed.~Subjects discontinued or entered the optional open-label extension period DRV/rtv + TDF/FTC."
1112276|NCT00534313|B5|Baseline|Total|Total of all reporting groups
1112277|NCT00534313|B4|Baseline|Placebo|Participants were administered iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141.
1112237|NCT00534352|P1|Participant Flow|TDF/FTC +/- TMC125 +/- DRV/Rtv|"In the first part of the trial (Days 1-14), all subjects received TMC125 400 mg once daily (qd) in combination with fixed dose combinations (FDC) of tenofovir disoproxil (TDF)/emtricitabine (FTC) 300/200 mg qd(Truvada®) for 14 days (Treatment A: TMC125 + TDF/FTC ). On Day 14, 24-hour intensive TMC125 pharmacokinetic sampling took place and fasting lipids were assessed.~In the second part of the trial (Days 15-28) darunavir (DRV)/ritonavir (rtv) 800/100 mg qd was added to the regimen (Treatment B: TMC 125 + TDF/FTC + DRV/rtv). On Day 28, 24-hour intensive pharmacokinetic sampling for TMC125, DRV and ritonavir took place and fasting lipids were assessed.~In the third part of the trial (Day 29-42), TMC125 was discontinued and subjects received treatment with DRV/rtv 800/100 mg q.d. and TDF/FTC FDC 300/200 mg qd (Treatment C: DRV/rtv + TDF/FTC).On Day 42, fasting lipids were assessed.~Subjects discontinued or entered the optional open-label extension period DRV/rtv + TDF/FTC."
1112238|NCT00534352|O1|Outcome|TDF/FTC +/- TMC125 +/- DRV/Rtv|"In the first part of the trial (Days 1-14), all subjects received TMC125 400 mg once daily (qd) in combination with fixed dose combinations (FDC) of tenofovir disoproxil (TDF)/emtricitabine (FTC) 300/200 mg qd(Truvada®) for 14 days (Treatment A: TMC125 + TDF/FTC ). On Day 14, 24-hour intensive TMC125 pharmacokinetic sampling took place and fasting lipids were assessed.~In the second part of the trial (Days 15-28) darunavir (DRV)/ritonavir (rtv) 800/100 mg qd was added to the regimen (Treatment B: TMC 125 + TDF/FTC + DRV/rtv). On Day 28, 24-hour intensive pharmacokinetic sampling for TMC125, DRV and ritonavir took place and fasting lipids were assessed.~In the third part of the trial (Day 29-42), TMC125 was discontinued and subjects received treatment with DRV/rtv 800/100 mg q.d. and TDF/FTC FDC 300/200 mg qd (Treatment C: DRV/rtv + TDF/FTC).On Day 42, fasting lipids were assessed.~Subjects discontinued or entered the optional open-label extension period DRV/rtv + TDF/FTC."
1112284|NCT00534313|P1|Participant Flow|Abatacept 30/10|Participants were administered intravenous (iv) infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Day 1 and 15 followed by fixed dose based on their screening visit weight i.e. for participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000 mg.
1112285|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
1112712|NCT00532779|B4|Baseline|Total|Total of all reporting groups
1112239|NCT00534352|O1|Outcome|TDF/FTC +/- TMC125 +/- DRV/Rtv|"In the first part of the trial (Days 1-14), all subjects received TMC125 400 mg once daily (qd) in combination with fixed dose combinations (FDC) of tenofovir disoproxil (TDF)/emtricitabine (FTC) 300/200 mg qd(Truvada®) for 14 days (Treatment A: TMC125 + TDF/FTC ). On Day 14, 24-hour intensive TMC125 pharmacokinetic sampling took place and fasting lipids were assessed.~In the second part of the trial (Days 15-28) darunavir (DRV)/ritonavir (rtv) 800/100 mg qd was added to the regimen (Treatment B: TMC 125 + TDF/FTC + DRV/rtv). On Day 28, 24-hour intensive pharmacokinetic sampling for TMC125, DRV and ritonavir took place and fasting lipids were assessed.~In the third part of the trial (Day 29-42), TMC125 was discontinued and subjects received treatment with DRV/rtv 800/100 mg q.d. and TDF/FTC FDC 300/200 mg qd (Treatment C: DRV/rtv + TDF/FTC).On Day 42, fasting lipids were assessed.~Subjects discontinued or entered the optional open-label extension period DRV/rtv + TDF/FTC."
1112240|NCT00534352|O1|Outcome|TDF/FTC +/- TMC125 +/- DRV/Rtv|"In the first part of the trial (Days 1-14), all subjects received TMC125 400 mg once daily (qd) in combination with fixed dose combinations (FDC) of tenofovir disoproxil (TDF)/emtricitabine (FTC) 300/200 mg qd(Truvada®) for 14 days (Treatment A: TMC125 + TDF/FTC ). On Day 14, 24-hour intensive TMC125 pharmacokinetic sampling took place and fasting lipids were assessed.~In the second part of the trial (Days 15-28) darunavir (DRV)/ritonavir (rtv) 800/100 mg qd was added to the regimen (Treatment B: TMC 125 + TDF/FTC + DRV/rtv). On Day 28, 24-hour intensive pharmacokinetic sampling for TMC125, DRV and ritonavir took place and fasting lipids were assessed.~In the third part of the trial (Day 29-42), TMC125 was discontinued and subjects received treatment with DRV/rtv 800/100 mg q.d. and TDF/FTC FDC 300/200 mg qd (Treatment C: DRV/rtv + TDF/FTC).On Day 42, fasting lipids were assessed.~Subjects discontinued or entered the optional open-label extension period DRV/rtv + TDF/FTC."
1112241|NCT00534352|O1|Outcome|TDF/FTC +/- TMC125 +/- DRV/Rtv|"In the first part of the trial (Days 1-14), all subjects received TMC125 400 mg once daily (qd) in combination with fixed dose combinations (FDC) of tenofovir disoproxil (TDF)/emtricitabine (FTC) 300/200 mg qd(Truvada®) for 14 days (Treatment A: TMC125 + TDF/FTC ). On Day 14, 24-hour intensive TMC125 pharmacokinetic sampling took place and fasting lipids were assessed.~In the second part of the trial (Days 15-28) darunavir (DRV)/ritonavir (rtv) 800/100 mg qd was added to the regimen (Treatment B: TMC 125 + TDF/FTC + DRV/rtv). On Day 28, 24-hour intensive pharmacokinetic sampling for TMC125, DRV and ritonavir took place and fasting lipids were assessed.~In the third part of the trial (Day 29-42), TMC125 was discontinued and subjects received treatment with DRV/rtv 800/100 mg q.d. and TDF/FTC FDC 300/200 mg qd (Treatment C: DRV/rtv + TDF/FTC).On Day 42, fasting lipids were assessed.~Subjects discontinued or entered the optional open-label extension period DRV/rtv + TDF/FTC."
1112242|NCT00534352|O4|Outcome|Optional Extension|DRV/rtv + TDF/FTC
1112243|NCT00534352|O3|Outcome|Treatment C|DRV/rtv + TDF/FTC
1112244|NCT00534352|O2|Outcome|Treatment B|TMC125 + TDF/FTC + DRV/rtv
1112245|NCT00534352|O1|Outcome|Treatment A|TMC125 + TDF/FTC
1112246|NCT00534352|O4|Outcome|Optional Extension|DRV/rtv + TDF/FTC
1112247|NCT00534352|O3|Outcome|Treatment C|DRV/rtv + TDF/FTC
1112248|NCT00534352|O2|Outcome|Treatment B|TMC125 + TDF/FTC + DRV/rtv
1112249|NCT00534352|O1|Outcome|Treatment A|TMC125 + TDF/FTC
1112250|NCT00534352|O4|Outcome|Optional Extension|DRV/rtv + TDF/FTC
1112251|NCT00534352|O3|Outcome|Treatment C|DRV/rtv + TDF/FTC
1112252|NCT00534352|O2|Outcome|Treatment B|TMC125 + TDF/FTC + DRV/rtv
1112253|NCT00534352|O1|Outcome|Treatment A|TMC125 + TDF/FTC
1112254|NCT00534352|O4|Outcome|Optional Extension|DRV/rtv + TDF/FTC
1112255|NCT00534352|O3|Outcome|Treatment C|DRV/rtv + TDF/FTC
1112256|NCT00534352|O2|Outcome|Treatment B|TMC125 + TDF/FTC + DRV/rtv
1112257|NCT00534352|O1|Outcome|Treatment A|TMC125 + TDF/FTC
1112258|NCT00534352|O4|Outcome|Optional Extension|DRV/rtv + TDF/FTC
1112259|NCT00534352|O3|Outcome|Treatment C|DRV/rtv + TDF/FTC
1112260|NCT00534352|O2|Outcome|Treatment B|TMC125 + TDF/FTC + DRV/rtv
1112261|NCT00534352|O1|Outcome|Treatment A|TMC125 + TDF/FTC
1112262|NCT00534352|O4|Outcome|Optional Extension|DRV/rtv + TDF/FTC
1112263|NCT00534352|O3|Outcome|Treatment C|DRV/rtv + TDF/FTC
1112264|NCT00534352|O2|Outcome|Treatment B|TMC125 + TDF/FTC + DRV/rtv
1112265|NCT00534352|O1|Outcome|Treatment A|TMC125 + TDF/FTC
1112266|NCT00534352|O4|Outcome|Optional Extension|DRV/rtv + TDF/FTC
1112267|NCT00534352|O3|Outcome|Treatment C|DRV/rtv + TDF/FTC
1112268|NCT00534352|O2|Outcome|Treatment B|TMC125 + TDF/FTC + DRV/rtv
1112269|NCT00534352|O1|Outcome|Treatment A|TMC125 + TDF/FTC
1112270|NCT00534352|O2|Outcome|Treatment B: TMC125 + TDF/FTC + DRV/Rtv|Treatment B: TMC125 + TDF/FTC + DRV/rtv.
1112278|NCT00534313|B3|Baseline|Abatacept 3/3|Participants were administered iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
1112279|NCT00534313|B2|Baseline|Abatacept 10/10|Participants were administered iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
1112280|NCT00534313|B1|Baseline|Abatacept 30/10|Participants were administered intravenous (iv) infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Day 1 and 15 followed by fixed dose based on their screening visit weight i.e. for participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000 mg.
1112281|NCT00534313|P4|Participant Flow|Placebo|Participants were administered iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141.
1112282|NCT00534313|P3|Participant Flow|Abatacept 3/3|Participants were administered iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
1112286|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
1112287|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg and participants weighing >100 kg received 1000mg).
1112288|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
1112289|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141.
1112290|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
1112291|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
1112292|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg -calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
1112293|NCT00534313|O4|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141.
1112294|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
1112295|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
1112529|NCT00533897|O1|Outcome|ABA [DB]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
1112296|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
1112297|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
1112298|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000mg).
1112299|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
1112300|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
1112301|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
1112302|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
1112713|NCT00532779|B3|Baseline|Placebo|Placebo
1112303|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141.
1112304|NCT00534313|O3|Outcome|Abatacept 3/3|Participants were administered iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
1112305|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
1112306|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg and participants weighing >100 kg received 1000 mg.
1112307|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
1112308|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 169. All participants received a dose based on their screening visit weight as per by rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000mg).
1112309|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Day 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
1112310|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141.
1112311|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose based on their screening visit weight.
1112312|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
1112331|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
1112313|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
1112314|NCT00534313|O4|Outcome|Placebo|Short-term period: Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
1112315|NCT00534313|O3|Outcome|Abatacept 3/3|Short-term period: Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
1112316|NCT00534313|O2|Outcome|Abatacept 10/10|Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg).
1112317|NCT00534313|O1|Outcome|Abatacept 30/10|Short-term period: Participants received IV infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg.
1112318|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141.
1112319|NCT00534313|O3|Outcome|Abatacept 3/3|Participants were administered iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
1112338|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
1114500|NCT00529451|O3|Outcome|Aliskiren 75 mg|Aliskiren 75 mg once daily
1112320|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
1112321|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
1112322|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141.
1112323|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
1112324|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
1112325|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Day 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
1112326|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
1112327|NCT00534313|O3|Outcome|Abatacept 3/3|Participants were administered iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
1112328|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
1112329|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
1112330|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
1113809|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1112332|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
1112333|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
1112334|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
1112335|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
1112336|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
1112337|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
1112399|NCT00533949|O3|Outcome|60 Gy RT + Cetuximab|60 gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
1112339|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
1112340|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
1112341|NCT00534313|O1|Outcome|Abatacept 30/10|Participants who received iv infusions of abatacept (30 mg/kg-calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Day 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
1112342|NCT00534313|O4|Outcome|Placebo|Short-term period: Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
1112343|NCT00534313|O3|Outcome|Abatacept 3/3|Short-term period: Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
1112344|NCT00534313|O2|Outcome|Abatacept 10/10|Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg).
1112345|NCT00534313|O1|Outcome|Abatacept 30/10|Short-term period: Participants received intravenous (IV) infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg.
1112346|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
1112347|NCT00534313|O3|Outcome|Abatacept 3/3|Participants were administered iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
1112348|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg and participants weighing >100 kg received 1000 mg).
1112349|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Day 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
1112350|NCT00534313|O4|Outcome|Placebo|Short-term period: Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
1112351|NCT00534313|O3|Outcome|Abatacept 3/3|Short-term period: Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
1112352|NCT00534313|O2|Outcome|Abatacept 10/10|Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg).Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
1112353|NCT00534313|O1|Outcome|Abatacept 30/10|Short-term period: Participants received intravenous (IV) infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
1112354|NCT00534313|O4|Outcome|Placebo|Short-term period: Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
1112355|NCT00534313|O3|Outcome|Abatacept 3/3|Short-term period: Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
1112356|NCT00534313|O2|Outcome|Abatacept 10/10|Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg).Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
1112357|NCT00534313|O1|Outcome|Abatacept 30/10|Short-term period: Participants received intravenous (IV) infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
1112358|NCT00534313|O4|Outcome|Placebo|Short-term period: Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
1112359|NCT00534313|O3|Outcome|Abatacept 3/3|Short-term period: Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
1112360|NCT00534313|O2|Outcome|Abatacept 10/10|Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg).Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
1112361|NCT00534313|O1|Outcome|Abatacept 30/10|Short-term period: Participants received IV infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
1112362|NCT00534313|O4|Outcome|Placebo|Short-term period: Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
1112363|NCT00534313|O3|Outcome|Abatacept 3/3|Short-term period: Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
1112385|NCT00534001|E2|Reported Event|Arm II (4-week run-in)|"Participants receive oral bupropion hydrochloride once or twice daily in weeks 1-4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.~bupropion hydrochloride: Given orally"
1112530|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
1112364|NCT00534313|O2|Outcome|Abatacept 10/10|Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg).Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
1112365|NCT00534313|O1|Outcome|Abatacept 30/10|Short-term period: Participants received IV infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
1112366|NCT00534313|O4|Outcome|Placebo|Short-term period: Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term period: Participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
1112367|NCT00534313|O3|Outcome|Abatacept 3/3|Short-term period: Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight. Long-term period: Participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
1112368|NCT00534313|O2|Outcome|Abatacept 10/10|Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg). Long-term period: Participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
1112400|NCT00533949|O2|Outcome|74 Gy RT|74 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
1112714|NCT00532779|B2|Baseline|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
1112369|NCT00534313|O1|Outcome|Abatacept 30/10|Short-term period: Participants received IV infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg. Long-term period: Participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
1112370|NCT00534313|O1|Outcome|All Treated Participants|Long-term period: All participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
1112371|NCT00534313|E5|Reported Event|Placebo (Short-term Period)|Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
1112372|NCT00534313|E4|Reported Event|Abatacept (Long-term Period)|Participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
1112373|NCT00534313|E3|Reported Event|Abatacept 30/10 (Short-term Period)|Participants received IV infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg.
1112374|NCT00534313|E2|Reported Event|Abatacept 3/3 (Short-term Period)|Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
1112375|NCT00534313|E1|Reported Event|Abatacept 10/10 (Short-term Period)|Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg).
1112376|NCT00534001|B3|Baseline|Total|Total of all reporting groups
1112377|NCT00534001|B2|Baseline|Arm II (4-week run-in)|"Participants receive oral bupropion hydrochloride once or twice daily in weeks 1-4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.~bupropion hydrochloride: Given orally"
1112378|NCT00534001|B1|Baseline|Arm I (1-week run-in)|"Participants receive an oral placebo once or twice daily in weeks 1-3 followed by oral bupropion hydrochloride once or twice daily in week 4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.~bupropion hydrochloride: Given orally~placebo: Given orally"
1112379|NCT00534001|P2|Participant Flow|4-week Run-in (Extended)|
1112380|NCT00534001|P1|Participant Flow|1-week Run In (Standard)|
1112381|NCT00534001|O2|Outcome|Arm II (4-week run-in)|"Participants receive oral bupropion hydrochloride once or twice daily in weeks 1-4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.~bupropion hydrochloride: Given orally"
1112382|NCT00534001|O1|Outcome|Arm I (1-week run-in)|"Participants receive an oral placebo once or twice daily in weeks 1-3 followed by oral bupropion hydrochloride once or twice daily in week 4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.~bupropion hydrochloride: Given orally~placebo: Given orally"
1112383|NCT00534001|O2|Outcome|Arm II (4-week run-in)|"Participants receive oral bupropion hydrochloride once or twice daily in weeks 1-4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.~bupropion hydrochloride: Given orally"
1112384|NCT00534001|O1|Outcome|Arm I (1-week run-in)|"Participants receive an oral placebo once or twice daily in weeks 1-3 followed by oral bupropion hydrochloride once or twice daily in week 4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.~bupropion hydrochloride: Given orally~placebo: Given orally"
1112386|NCT00534001|E1|Reported Event|Arm I (1-week run-in)|"Participants receive an oral placebo once or twice daily in weeks 1-3 followed by oral bupropion hydrochloride once or twice daily in week 4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.~bupropion hydrochloride: Given orally~placebo: Given orally"
1112387|NCT00533949|B5|Baseline|Total|Total of all reporting groups
1112388|NCT00533949|B4|Baseline|74 Gy RT + Cetuximab|74 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
1112389|NCT00533949|B3|Baseline|60 Gy RT + Cetuximab|60 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
1112390|NCT00533949|B2|Baseline|74 Gy RT|74 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
1112391|NCT00533949|B1|Baseline|60 Gy RT|60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
1112392|NCT00533949|P4|Participant Flow|74 Gy RT + Cetuximab|74 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
1112393|NCT00533949|P3|Participant Flow|60 Gy RT + Cetuximab|60 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
1112394|NCT00533949|P2|Participant Flow|74 Gy RT|74 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
1112395|NCT00533949|P1|Participant Flow|60 Gy RT|60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
1112396|NCT00533949|O2|Outcome|Combined Patients Receiving 74 Gy RT|Combining patients from arms receiving 74 Gy RT (74 Gy RT and 74 Gy RT + Cetuximab)
1112397|NCT00533949|O1|Outcome|Combined Patients Receiving 60 Gy RT|Combining patients from arms receiving 60 Gy RT (60 Gy RT and 60 Gy RT + Cetuximab)
1112398|NCT00533949|O4|Outcome|74 Gy RT + Cetuximab|74 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
1112715|NCT00532779|B1|Baseline|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
1112401|NCT00533949|O1|Outcome|60 Gy RT|60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
1112402|NCT00533949|O2|Outcome|Combined Patients Receiving 74 Gy RT|Combining patients from arms receiving 74 Gy RT (74 Gy RT and 74 Gy RT + Cetuximab)
1112403|NCT00533949|O1|Outcome|Combined Patients Receiving 60 Gy RT|Combining patients from arms receiving 60 Gy RT (60 Gy RT and 60 Gy RT + Cetuximab)
1112404|NCT00533949|O2|Outcome|Combined Patients Receiving 74 Gy RT|Combining patients from arms receiving 74 Gy RT (74 Gy RT and 74 Gy RT + Cetuximab)
1112405|NCT00533949|O1|Outcome|Combined Patients Receiving 60 Gy RT|Combining patients from arms receiving 60 Gy RT (60 Gy RT and 60 Gy RT + Cetuximab)
1112406|NCT00533949|O4|Outcome|Combined Patients From Arms Receiving No Cetuximab|Combining patients from arms receiving No Cetuximab (60 Gy RT and 74 Gy RT
1112407|NCT00533949|O3|Outcome|Combined Patients Receiving Cetuximab|Combining patients from arms receiving Cetuximab (60 Gy RT + Cetuximab and 74 Gy RT + Cetuximab)
1112408|NCT00533949|O2|Outcome|Combined Patients Receiving 74 Gy RT|Combining patients from arms receiving 74 Gy RT (74 Gy RT and 74 Gy RT + Cetuximab)
1112409|NCT00533949|O1|Outcome|Combined Patients Receiving 60 Gy RT|Combining patients from arms receiving 60 Gy RT (60 Gy RT and 60 Gy RT + Cetuximab)
1112410|NCT00533949|O4|Outcome|Combined Patients From Arms Receiving No Cetuximab|Combining patients from arms receiving No Cetuximab (60 Gy RT and 74 Gy RT
1112411|NCT00533949|O3|Outcome|Combined Patients Receiving Cetuximab|Combining patients from arms receiving Cetuximab (60 Gy RT + Cetuximab and 74 Gy RT + Cetuximab)
1112412|NCT00533949|O2|Outcome|Combined Patients Receiving 74 Gy RT|Combining patients from arms receiving 74 Gy RT (74 Gy RT and 74 Gy RT + Cetuximab)
1112413|NCT00533949|O1|Outcome|Combined Patients Receiving 60 Gy RT|Combining patients from arms receiving 60 Gy RT (60 Gy RT and 60 Gy RT + Cetuximab)
1112414|NCT00533949|O4|Outcome|Combined Patients From Arms Receiving No Cetuximab|Combining patients from arms receiving No Cetuximab (60 Gy RT and 74 Gy RT
1112415|NCT00533949|O3|Outcome|Combined Patients Receiving Cetuximab|Combining patients from arms receiving Cetuximab (60 Gy RT + Cetuximab and 74 Gy RT + Cetuximab)
1112416|NCT00533949|O2|Outcome|Combined Patients Receiving 74 Gy RT|Combining patients from arms receiving 74 Gy RT (74 Gy RT and 74 Gy RT + Cetuximab)
1112417|NCT00533949|O1|Outcome|Combined Patients Receiving 60 Gy RT|Combining patients from arms receiving 60 Gy radiation therapy (RT) (60 Gy RT and 60 Gy RT + Cetuximab)
1112418|NCT00533949|E4|Reported Event|74 Gy RT + Cetuximab|74 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
1112419|NCT00533949|E3|Reported Event|60 Gy RT + Cetuximab|60 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
1112420|NCT00533949|E2|Reported Event|74 Gy RT|74 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
1112421|NCT00533949|E1|Reported Event|60 Gy RT|60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
1112422|NCT00533897|B4|Baseline|Total|Total of all reporting groups
1112423|NCT00533897|B3|Baseline|Placebo Received in Period 2|Participants received ABA IV loading dose and SC injections (fixed dose of 125 mg abatacept) on Day 1 followed by weekly SC injections of ABA up to Day 85 during the Lead-in Period (Period 1). Period 1 responders continued into Period 2 and were randomized to Placebo (Day 85-169).
1112424|NCT00533897|B2|Baseline|Abatacept Received in Period 2|Participants received ABA IV loading dose and SC injections (fixed dose of 125 mg abatacept) on Day 1 followed by weekly SC injections of ABA up to Day 85 during the Lead-in Period (Period 1). Period 1 responders continued into Period 2 and were randomized to ABA (Day 85-169).
1121508|NCT00513305|B3|Baseline|Total|Total of all reporting groups
1112425|NCT00533897|B1|Baseline|Period 1 Non-Responders|Participants received abatacept (ABA) intravenous (IV) loading dose and subcutaneous (SC) injections (fixed dose of 125 mg abatacept) on Day 1 followed by weekly SC injections of ABA up to Day 85 during the Lead-in Period (Period 1). Period 1 non-responders skipped Periods 2 and 3 and entered the long term extension (LTE).
1112426|NCT00533897|P8|Participant Flow|Long Term Extension (LTE) Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, could enter the LTE on Day 253 and receive weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
1112427|NCT00533897|P7|Participant Flow|Long Term Extension Abatacept for LI Period Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve Disease Activity Score 28 (DAS28-CRP) decrease by ≥ 0.6 from Day 1), they directly entered the Long Term Extension (LTE) receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
1112428|NCT00533897|P6|Participant Flow|PLA Switched to ABA With PLA IV Loading Dose in RI Period|After receiving ABA in the Lead-In, and PLA in the DBW Period, participants were randomized to receive a single Placebo IV loading dose on Day 169 followed by weekly open-label SC ABA injections (fixed dose of 125 mg) in the RI Period.
1112429|NCT00533897|P5|Participant Flow|PLA Switched to ABA With ABA IV Loading Dose in RI Period|After receiving ABA in LI period, and PLA in the DBW Period, participants were randomized to receive a single weight-titered ABA IV loading dose (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) followed by weekly open-label SC ABA injections (fixed dose of 125 mg) in the RI Period.
1112430|NCT00533897|P4|Participant Flow|ABA With IV PLA Loading Dose in Re-introduction (RI) Period|After receiving ABA in LI Period, and ABA in DBW Period, participants received a single blinded placebo IV dose on Day 169 and continued with weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg) in the RI Period.
1112716|NCT00532779|P3|Participant Flow|Placebo|Placebo
1112431|NCT00533897|P3|Participant Flow|Placebo (PLA) Double Blind Withdrawal (DBW)|After receiving ABA in the LI Period, participants received double blind Placebo SC injections starting on Day 85 and weekly for 12 weeks.
1112432|NCT00533897|P2|Participant Flow|Abatacept (ABA) Double-blind Withdrawal (DBW)|After receiving ABA in the LI, participants received double blind ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
1112433|NCT00533897|P1|Participant Flow|Abatacept (ABA) [Lead-In (LI)]|On Day 1 of the 12 week Lead-In (LI), participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
1112434|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
1112435|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
1112436|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
1112437|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
1112438|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
1112439|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
1122343|NCT00510835|B4|Baseline|Total|Total of all reporting groups
1112440|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
1112441|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
1112442|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
1112443|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
1112507|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
1114501|NCT00529451|O2|Outcome|Aliskiren 150 mg|Aliskiren 150 mg once daily
1112444|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
1112445|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
1112446|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
1112447|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
1112448|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
1112449|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
1112450|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
1112464|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
1112465|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
1112531|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
1112451|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
1112452|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, could enter the LTE on Day 253 and receive weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
1112453|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
1112454|NCT00533897|O1|Outcome|LTE Abatacept for All Participants|This group includes all participants who received at least one dose of 125 mg SC Abatacept during the LTE and includes both the LI Period 1 non-responder and the ST Completer cohorts.
1112474|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
1114502|NCT00529451|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg once daily
1112455|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
1112456|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
1112457|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
1112458|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
1112459|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
1112460|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
1112461|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
1112462|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
1112463|NCT00533897|O2|Outcome|Placebo (PLA) [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
1122358|NCT00510809|B2|Baseline|Statin and Placebo|20mg daily, double-blind
1112466|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
1112467|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
1112468|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
1112469|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
1112470|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
1112471|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
1112472|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
1112473|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
1115868|NCT00527319|O1|Outcome|Group A, Control Group|Supportive care only
1112475|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
1112476|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
1112477|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
1112478|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
1112479|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
1112480|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
1112481|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
1112482|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
1112483|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
1112484|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
1112485|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
1112486|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
1112487|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
1112488|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
1112489|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
1112490|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
1112491|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
1112492|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
1112493|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
1113810|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1112494|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
1112495|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
1112496|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
1112497|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
1112498|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
1112499|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
1112500|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
1112501|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
1112502|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
1112503|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
1112504|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
1112505|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
1112506|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
1112509|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
1112510|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
1112511|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
1112512|NCT00533897|O2|Outcome|Placebo (PLA) [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
1112513|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
1112514|NCT00533897|O2|Outcome|Placebo (PLA) [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
1112515|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
1112516|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
1112517|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
1112518|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
1112519|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
1112520|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
1112521|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
1112522|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
1112523|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
1112524|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
1112525|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
1112526|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
1112527|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
1112528|NCT00533897|O2|Outcome|PLA [DB]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
1122439|NCT00510484|O1|Outcome|Pancrelipase|
1112532|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
1112533|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
1112534|NCT00533897|O2|Outcome|PLA [DB]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
1112535|NCT00533897|O1|Outcome|ABA [DB]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
1112536|NCT00533897|O2|Outcome|Placebo (PLA) [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
1112537|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
1112538|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
1112539|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
1112540|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
1112541|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
1112542|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
1112543|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
1112544|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
1112545|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
1112546|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
1112717|NCT00532779|P2|Participant Flow|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
1112547|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
1112548|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
1112549|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
1112550|NCT00533897|O2|Outcome|PLA in DBW Period|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
1112551|NCT00533897|O1|Outcome|ABA in DBW Period|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
1112552|NCT00533897|O2|Outcome|PLA in DBW Period|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
1112553|NCT00533897|O1|Outcome|ABA in DBW Period|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
1112554|NCT00533897|O2|Outcome|PLA in DBW Period|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
1112555|NCT00533897|O1|Outcome|ABA in DBW Period|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
1112556|NCT00533897|O2|Outcome|Placebo in DBW Period|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
1112557|NCT00533897|O1|Outcome|ABA in DBW Period|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
1112558|NCT00533897|O2|Outcome|Placebo in DBW Period|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
1112559|NCT00533897|O1|Outcome|Abatacept in DBW Period|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
1112560|NCT00533897|O1|Outcome|Abatacept in Lead-In Period|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
1112561|NCT00533897|O1|Outcome|Abatacept in Lead-In Period|On Day 1, participants received a single intravenous (IV) Abatacept (ABA) dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
1112562|NCT00533897|O2|Outcome|PLA Switched to ABA With PLA IV Loading Dose in RI Period|On Day 169, participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced in the RI Period.
1112563|NCT00533897|O1|Outcome|PLA Switched to ABA With ABA IV Loading Dose in RI Period|On Day 169, participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced in the RI Period.
1112564|NCT00533897|O2|Outcome|Placebo in DBW Period|Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
1112565|NCT00533897|O1|Outcome|Abatacept in DBW Period|Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
1112566|NCT00533897|E4|Reported Event|Placebo Received in Period 2|Participants who responded to abatacept in Period 1, entered Period 2 and were randomized to receive Placebo SC injections starting on Day 85 and weekly for 12 weeks. Abatacept SC injections of 125 mg were administered during Reintroduction Period 3 and during the LTE Period until completion of the LTE.
1112567|NCT00533897|E3|Reported Event|Abatacept Received in Period 2|Participants who responded to abatacept in Period 1, entered Period 2 and were randomized to receive Abatacept SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks. Abatacept SC injections of 125 mg were continued in Reintroduction Period 3 and during the LTE Period until completion of the LTE.
1112568|NCT00533897|E2|Reported Event|Period 1 Non-Responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 until completion of the LTE.
1122440|NCT00510484|O2|Outcome|Placebo|
1112569|NCT00533897|E1|Reported Event|Period 1 Non-Completers|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. These participants did not complete the Period and did not continue in the study.
1112570|NCT00533702|B3|Baseline|Total|Total of all reporting groups
1112571|NCT00533702|B2|Baseline|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
1112572|NCT00533702|B1|Baseline|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
1112573|NCT00533702|P2|Participant Flow|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
1112574|NCT00533702|P1|Participant Flow|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
1112575|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
1112576|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
1116926|NCT00524264|B1|Baseline|Ketorolac Solution|
1112577|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
1112578|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
1112579|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
1112580|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
1112581|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
1112582|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
1112583|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
1112584|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
1112585|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
1112586|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
1112587|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
1112588|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
1112589|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
1112590|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
1112591|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
1112592|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
1112593|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
1112594|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
1112595|NCT00533702|E2|Reported Event|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
1112596|NCT00533702|E1|Reported Event|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
1112597|NCT00533546|B1|Baseline|Intravenous APC 10 Microgram/kg Dose|"Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.~Activated Protein C : Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset"
1112598|NCT00533546|P1|Participant Flow|Intravenous APC 10 Microgram/kg Dose|"Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.~Activated Protein C : Intravenous APC (10 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset"
1112599|NCT00533546|O1|Outcome|Intravenous APC 10 Microgram/kg Dose|"Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.~Activated Protein C: Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset"
1112600|NCT00533546|O1|Outcome|Intravenous APC 10 Microgram/kg Dose|"Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.~Activated Protein C: Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset"
1112601|NCT00533546|O1|Outcome|Intravenous APC 10 Microgram/kg Dose|"Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.~Activated Protein C: Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset"
1112602|NCT00533546|O1|Outcome|Intravenous APC 10 Microgram/kg Dose|"Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.~Activated Protein C : Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset"
1112603|NCT00533546|E1|Reported Event|Intravenous APC 10 Microgram/kg Dose|"Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.~Activated Protein C : Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset"
1112604|NCT00533507|B1|Baseline|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
1112605|NCT00533507|P1|Participant Flow|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
1112606|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
1112607|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
1112608|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
1112609|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
1112610|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
1112611|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
1112612|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
1112613|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
1112614|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
1112615|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
1113811|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1112616|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
1112617|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
1112618|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
1112619|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
1112620|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
1112621|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
1112622|NCT00533507|E1|Reported Event|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
1112623|NCT00532948|B4|Baseline|Total|Total of all reporting groups
1112624|NCT00532948|B3|Baseline|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy.
1112625|NCT00532948|B2|Baseline|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy.
1112626|NCT00532948|B1|Baseline|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy.
1112627|NCT00532948|P3|Participant Flow|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy.
1112628|NCT00532948|P2|Participant Flow|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy.
1112629|NCT00532948|P1|Participant Flow|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy.
1112630|NCT00532948|O3|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
1112631|NCT00532948|O2|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
1112632|NCT00532948|O1|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
1112633|NCT00532948|O3|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
1112634|NCT00532948|O2|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
1112635|NCT00532948|O1|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
1112636|NCT00532948|O3|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
1112637|NCT00532948|O2|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
1112638|NCT00532948|O1|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
1112639|NCT00532948|O3|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
1112640|NCT00532948|O2|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
1112641|NCT00532948|O1|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
1122441|NCT00510484|O1|Outcome|Pancrelipase|
1112642|NCT00532948|O3|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
1112643|NCT00532948|O2|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
1112644|NCT00532948|O1|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
1112645|NCT00532948|O3|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
1112646|NCT00532948|O2|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
1112647|NCT00532948|O1|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
1112648|NCT00532948|O3|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
1112718|NCT00532779|P1|Participant Flow|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
1112719|NCT00532779|O3|Outcome|Placebo|Placebo
1112649|NCT00532948|O2|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
1112650|NCT00532948|O1|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
1112651|NCT00532948|O3|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
1112652|NCT00532948|O2|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
1112653|NCT00532948|O1|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
1112654|NCT00532948|O1|Outcome|Capecitabine (Overall)|Capecitabine 500, 650, and 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
1112655|NCT00532948|E3|Reported Event|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
1112656|NCT00532948|E2|Reported Event|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
1112657|NCT00532948|E1|Reported Event|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
1112658|NCT00532935|B3|Baseline|Total|Total of all reporting groups
1112659|NCT00532935|B2|Baseline|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
1112660|NCT00532935|B1|Baseline|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
1112661|NCT00532935|P2|Participant Flow|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
1112662|NCT00532935|P1|Participant Flow|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
1112663|NCT00532935|O2|Outcome|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
1112696|NCT00532883|B4|Baseline|HU Placebo/Mg Placebo|Placebo for both hydroxyurea (20 mg/kg/day) and liquid magnesium pidolate (0.6 mEq/kg/day).
1112697|NCT00532883|B3|Baseline|HU Placebo/Magnesium|HU placebo combined with liquid magnesium pidolate (0.6 mEq/kg/day).
1122442|NCT00510484|O2|Outcome|Placebo|
1112664|NCT00532935|O1|Outcome|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
1112665|NCT00532935|O2|Outcome|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
1112666|NCT00532935|O1|Outcome|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
1112667|NCT00532935|O2|Outcome|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
1112720|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
1112721|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
1112722|NCT00532779|O3|Outcome|Placebo|Placebo
1112723|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
1112668|NCT00532935|O1|Outcome|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
1112669|NCT00532935|O2|Outcome|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
1112670|NCT00532935|O1|Outcome|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
1112671|NCT00532935|O2|Outcome|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
1112672|NCT00532935|O1|Outcome|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
1112673|NCT00532935|E2|Reported Event|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
1112674|NCT00532935|E1|Reported Event|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
1112675|NCT00533351|B3|Baseline|Total|Total of all reporting groups
1112676|NCT00533351|B2|Baseline|Placebo Followed by AGN201781|
1112677|NCT00533351|B1|Baseline|AGN201781 Followed by Placebo|
1112678|NCT00533351|P2|Participant Flow|Placebo Followed by AGN201781|
1112679|NCT00533351|P1|Participant Flow|AGN201781 Followed by Placebo|
1112680|NCT00533351|O2|Outcome|Placebo|
1112681|NCT00533351|O1|Outcome|AGN201781|
1112682|NCT00533351|O2|Outcome|Placebo|
1112683|NCT00533351|O1|Outcome|AGN201781|
1112684|NCT00533351|E2|Reported Event|Placebo Followed by AGN201781|
1112685|NCT00533351|E1|Reported Event|AGN201781 Followed by Placebo|
1112686|NCT00533273|B3|Baseline|Total|Total of all reporting groups
1112687|NCT00533273|B2|Baseline|Placebo|Placebo (Sucrose and Tris)
1112688|NCT00533273|B1|Baseline|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
1112689|NCT00533273|P2|Participant Flow|Placebo|Placebo for injection was comprised of sucrose and Tris
1112690|NCT00533273|P1|Participant Flow|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
1112691|NCT00533273|O2|Outcome|Placebo|Placebo injection is comprised of sucrose and Tris
1112692|NCT00533273|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
1112693|NCT00533273|E2|Reported Event|Placebo|Placebo injection is comprised of sucrose and Tris
1112694|NCT00533273|E1|Reported Event|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
1112695|NCT00532883|B5|Baseline|Total|Total of all reporting groups
1112698|NCT00532883|B2|Baseline|Hydroxyurea/Mg Placebo|Hydroxyurea (20 mg/kg/day) combined with liquid Mg placebo.
1112699|NCT00532883|B1|Baseline|Hydroxyurea/Magnesium|Hydroxyurea (20 mg/kg/day) combined with liquid magnesium pidolate (0.6 mEq/kg/day).
1112700|NCT00532883|P4|Participant Flow|HU Placebo/Mg Placebo|Placebo for both hydroxyurea (20 mg/kg/day) and liquid magnesium pidolate (0.6 mEq/kg/day).
1112701|NCT00532883|P3|Participant Flow|HU Placebo/Magnesium|HU placebo combined with liquid magnesium pidolate (0.6 mEq/kg/day).
1112702|NCT00532883|P2|Participant Flow|Hydroxyurea/Mg Placebo|Hydroxyurea (20 mg/kg/day) combined with liquid Mg placebo.
1112703|NCT00532883|P1|Participant Flow|Hydroxyurea/Magnesium|Hydroxyurea (20 mg/kg/day) combined with liquid magnesium pidolate (0.6 mEq/kg/day).
1112704|NCT00532883|O4|Outcome|HU Placebo/Mg Placebo|Placebo for both hydroxyurea (20 mg/kg/day) and liquid magnesium pidolate (0.6 mEq/kg/day).
1112705|NCT00532883|O3|Outcome|HU Placebo/Magnesium|HU placebo combined with liquid magnesium pidolate (0.6 mEq/kg/day).
1112706|NCT00532883|O2|Outcome|Hydroxyurea/Mg Placebo|Hydroxyurea (20 mg/kg/day) combined with liquid Mg placebo.
1112707|NCT00532883|O1|Outcome|Hydroxyurea/Magnesium|Hydroxyurea (20 mg/kg/day) combined with liquid magnesium pidolate (0.6 mEq/kg/day).
1112708|NCT00532883|E4|Reported Event|Placebo/Placebo|
1112709|NCT00532883|E3|Reported Event|Placebo/Magnesium Pidolate|20 mg/kg/day HU + 0.6 mEq/kg/day Mg
1112710|NCT00532883|E2|Reported Event|Hydroxyurea/Placebo|0.6 mEq/kg/day
1112711|NCT00532883|E1|Reported Event|Hydroxyurea/Magnesium Pidolate|20 mg/kg/day
1112724|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
1112725|NCT00532779|O3|Outcome|Placebo|Placebo
1112726|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
1112727|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
1112728|NCT00532779|O3|Outcome|Placebo|Placebo
1112729|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
1112730|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
1112731|NCT00532779|O3|Outcome|Placebo|Placebo
1112732|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
1112733|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
1112734|NCT00532779|O3|Outcome|Placebo|Placebo
1112735|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
1112736|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
1112737|NCT00532779|O3|Outcome|Placebo|Placebo
1112738|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
1112739|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
1112740|NCT00532779|O3|Outcome|Placebo|Placebo
1112741|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
1112742|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
1112743|NCT00532779|O3|Outcome|Placebo|Placebo
1112744|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
1112745|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
1112746|NCT00532779|O3|Outcome|Placebo|Placebo
1112747|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
1112748|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
1112749|NCT00532779|O3|Outcome|Placebo|Placebo
1112750|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
1112751|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
1112752|NCT00532779|O3|Outcome|Placebo|Placebo
1112753|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
1112754|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
1112755|NCT00532779|O3|Outcome|Placebo|Placebo
1112756|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
1112757|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
1112758|NCT00532779|O3|Outcome|Placebo|Placebo
1112759|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
1112760|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
1112761|NCT00532779|O3|Outcome|Placebo|Placebo
1112762|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
1112763|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
1112764|NCT00532779|O3|Outcome|Placebo|Placebo
1112765|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
1112766|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
1112767|NCT00532779|O3|Outcome|Placebo|Placebo
1112768|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
1112769|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
1112770|NCT00532779|O3|Outcome|Placebo|Placebo
1112771|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
1112772|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
1112773|NCT00532779|E3|Reported Event|Placebo|Placebo
1112774|NCT00532779|E2|Reported Event|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
1112777|NCT00532493|B2|Baseline|Placebo Group|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
1112778|NCT00532493|B1|Baseline|Prazosin Group|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
1112779|NCT00532493|P2|Participant Flow|Placebo Group|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
1112780|NCT00532493|P1|Participant Flow|Prazosin Group|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
1112781|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
1112782|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
1112783|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
1112784|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
1112785|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
1112786|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
1112787|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
1112788|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
1112789|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
1112790|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
1112791|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
1112792|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
1112793|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
1113047|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1112794|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
1112795|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
1112796|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
1112797|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
1112798|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
1112799|NCT00532493|O2|Outcome|Placebo Group|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
1112993|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1112800|NCT00532493|O1|Outcome|Prazosin Group|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
1112801|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
1112802|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
1112803|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
1112804|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
1112805|NCT00532493|O2|Outcome|Placebo Group|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
1112806|NCT00532493|O1|Outcome|Prazosin Group|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
1112807|NCT00532493|E2|Reported Event|Placebo Group|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
1112808|NCT00532493|E1|Reported Event|Prazosin Group|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
1112809|NCT00532480|B1|Baseline|Duloxetine|Duloxetine : 60 mg capsules
1112810|NCT00532480|P1|Participant Flow|Duloxetine|Duloxetine 60 mg capsules orally daily open label
1112811|NCT00532480|O1|Outcome|Duloxetine|Duloxetine : 60 mg capsules
1112812|NCT00532480|E1|Reported Event|Duloxetine|Duloxetine : 60 mg capsules
1112813|NCT00532441|B1|Baseline|Erlotinib and Docetaxel|"Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15~Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15"
1112814|NCT00532441|P2|Participant Flow|Biliary|erlotinib and docetaxel
1112815|NCT00532441|P1|Participant Flow|Hepatocellular|erlotinib and docetaxel
1112816|NCT00532441|O2|Outcome|Biliary|erlotinib and docetaxel
1112817|NCT00532441|O1|Outcome|Hepatocellular|erlotinib and docetaxel
1112818|NCT00532441|O2|Outcome|Erlotinib and Docetaxel: Hepatocellular|"Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15~Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15"
1112819|NCT00532441|O1|Outcome|Erlotinib and Docetaxel: Biliary|"Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15~Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15"
1112820|NCT00532441|O2|Outcome|Hepatocellular|Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28 Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15 Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28 Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15
1112821|NCT00532441|O1|Outcome|Biliary|"Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15~Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15"
1112822|NCT00532441|E1|Reported Event|Erlotinib and Docetaxel|"Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15~Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15"
1112823|NCT00532298|B7|Baseline|Total|Total of all reporting groups
1112824|NCT00532298|B6|Baseline|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
1112825|NCT00532298|B5|Baseline|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
1112826|NCT00532298|B4|Baseline|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
1112827|NCT00532298|B3|Baseline|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
1112828|NCT00532298|B2|Baseline|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
1112829|NCT00532298|B1|Baseline|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
1112830|NCT00532298|P6|Participant Flow|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
1112831|NCT00532298|P5|Participant Flow|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
1112832|NCT00532298|P4|Participant Flow|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
1112833|NCT00532298|P3|Participant Flow|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
1112834|NCT00532298|P2|Participant Flow|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
1112835|NCT00532298|P1|Participant Flow|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
1112836|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
1112837|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
1112838|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
1112839|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
1112840|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
1112841|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
1112842|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
1112843|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
1113108|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
1112844|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
1112845|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
1112846|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
1112847|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
1112848|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
1112849|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
1112850|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
1112851|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
1112852|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
1112853|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
1112854|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
1112855|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
1112856|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
1112857|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
1112858|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
1112859|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
1112860|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
1112861|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
1112862|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
1112863|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
1112864|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
1112865|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
1112866|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
1112867|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
1112868|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
1112869|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
1112870|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
1112871|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
1112872|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
1112873|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
1112874|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
1112875|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
1112876|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
1112877|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
1112878|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
1112879|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
1112880|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
1112881|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
1112882|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
1112883|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
1112884|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
1112885|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
1112886|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
1112887|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
1112888|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
1112889|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
1112890|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
1112891|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
1112892|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
1112893|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
1112894|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
1112895|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
1112896|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
1112897|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
1112898|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
1112899|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
1112900|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
1112901|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
1112902|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
1112903|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
1112904|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
1112905|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
1112906|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
1112907|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
1112908|NCT00532298|E6|Reported Event|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
1112909|NCT00532298|E5|Reported Event|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
1112910|NCT00532298|E4|Reported Event|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
1112911|NCT00532298|E3|Reported Event|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
1112912|NCT00532298|E2|Reported Event|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
1112913|NCT00532298|E1|Reported Event|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
1112914|NCT00532259|B1|Baseline|CT-011 Antibody|CT-011 : IV infusion of 1.5 mg/kg of CT-011 on Day 1(30 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
1112915|NCT00532259|P1|Participant Flow|CT-011 Antibody|CT-011 : IV infusion of 1.5 mg/kg of CT-011 on Day 1(30 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
1113603|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
1112916|NCT00532259|O1|Outcome|CT-011|CT-011: IV infusion of 1.5 mg/kg of CT-011 on Day 1(60 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
1112917|NCT00532259|O1|Outcome|CT-011 Antibody|CT-011 : IV infusion of 1.5 mg/kg of CT-011 on Day 1(30 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
1112918|NCT00532259|E1|Reported Event|CT-011 Antibody|CT-011 : IV infusion of 1.5 mg/kg of CT-011 on Day 1(30 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
1112919|NCT00532155|B3|Baseline|Total|Total of all reporting groups
1112920|NCT00532155|B2|Baseline|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant’s refusal.
1112921|NCT00532155|B1|Baseline|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
1112922|NCT00532155|P2|Participant Flow|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
1112923|NCT00532155|P1|Participant Flow|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
1112924|NCT00532155|O2|Outcome|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
1112925|NCT00532155|O1|Outcome|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
1112926|NCT00532155|O2|Outcome|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
1112927|NCT00532155|O1|Outcome|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
1112928|NCT00532155|O2|Outcome|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
1112929|NCT00532155|O1|Outcome|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
1112930|NCT00532155|O2|Outcome|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
1112931|NCT00532155|O1|Outcome|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
1112932|NCT00532155|O2|Outcome|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
1112933|NCT00532155|O1|Outcome|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
1112934|NCT00532155|E2|Reported Event|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant’s refusal.
1112935|NCT00532155|E1|Reported Event|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
1112936|NCT00532129|B1|Baseline|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
1112937|NCT00532129|P1|Participant Flow|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles (28 day cycles). Participants who did not achieve complete response (CR) after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 milligrams per square meter per day (mg/m^2/day) oral administration (PO) on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
1112938|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
1112939|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
1112940|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
1112941|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
1112942|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
1112943|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
1112944|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
1112945|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
1112946|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
1112947|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
1112948|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
1113109|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
1113812|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1112949|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
1112950|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
1112951|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
1112952|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
1112994|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1113764|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1112953|NCT00532129|E1|Reported Event|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
1112954|NCT00531960|B3|Baseline|Total|Total of all reporting groups
1112955|NCT00531960|B2|Baseline|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
1112956|NCT00531960|B1|Baseline|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
1112957|NCT00531960|P2|Participant Flow|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, orally (PO), daily until disease progression, unacceptable toxicity, death, or withdrawal.
1112958|NCT00531960|P1|Participant Flow|Bevacizumab Plus (+) Chemotherapy|Participants received bevacizumab 15 milligrams per kilogram (mg/kg), intravenously (IV), on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 milligrams per square meter [mg/m^2], IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 milligrams per milliliter multiplied by minute [mg/mL*min] on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
1112959|NCT00531960|O2|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
1112960|NCT00531960|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
1112961|NCT00531960|O2|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
1112962|NCT00531960|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
1112963|NCT00531960|O2|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
1122443|NCT00510484|O1|Outcome|Pancrelipase|
1112964|NCT00531960|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
1112965|NCT00531960|O2|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
1112966|NCT00531960|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
1112967|NCT00531960|O2|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
1112968|NCT00531960|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
1112969|NCT00531960|O2|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
1112970|NCT00531960|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
1112971|NCT00531960|E2|Reported Event|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
1112972|NCT00531960|E1|Reported Event|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
1112973|NCT00531947|B3|Baseline|Total|Total of all reporting groups
1112974|NCT00531947|B2|Baseline|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1112975|NCT00531947|B1|Baseline|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1112976|NCT00531947|P2|Participant Flow|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1112977|NCT00531947|P1|Participant Flow|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1112978|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1112979|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1112980|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1112981|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1112982|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1112983|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1113110|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
1112984|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1112985|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1112986|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1112987|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1112988|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1112989|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1112990|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1112991|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1112992|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1112995|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1112996|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1112997|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1112998|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1112999|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1113000|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1113001|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1113002|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1113003|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1113004|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1113005|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1113006|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1113007|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1113008|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1113009|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1113010|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1113011|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1113012|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1113013|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1113014|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1113015|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1122444|NCT00510484|O2|Outcome|Placebo|
1113016|NCT00531947|E2|Reported Event|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1113017|NCT00531947|E1|Reported Event|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
1113018|NCT00531934|B3|Baseline|Total|Total of all reporting groups
1113019|NCT00531934|B2|Baseline|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113020|NCT00531934|B1|Baseline|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113021|NCT00531934|P2|Participant Flow|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113022|NCT00531934|P1|Participant Flow|Erlotinib Plus (+) Doxycycline|Participants received erlotinib 150 milligrams per day (mg/day), tablets, orally (PO) until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113023|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113024|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113025|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113026|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113027|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113028|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113029|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113030|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113031|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113032|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113033|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113034|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113035|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113036|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113037|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113038|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113039|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113040|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113041|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113042|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113043|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113044|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113045|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113046|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1122445|NCT00510484|O1|Outcome|Pancrelipase|
1113048|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113049|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113050|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113051|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113052|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113053|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113054|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113055|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113056|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113057|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113604|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
1113058|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113059|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113060|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113061|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113062|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113063|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113064|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113065|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113066|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113067|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113068|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113069|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113070|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113071|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113072|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113073|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113074|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113075|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113076|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113077|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113111|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
1122446|NCT00510484|O2|Outcome|Placebo|
1113078|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113079|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113080|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113081|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113082|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113083|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113084|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113085|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113086|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113087|NCT00531934|E2|Reported Event|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
1113088|NCT00531934|E1|Reported Event|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
1113089|NCT00531843|B3|Baseline|Total|Total of all reporting groups
1113090|NCT00531843|B2|Baseline|No Fondaparinux|Patients at high risk or very high risk for venous thromboembolism AND contraindication to anticoagulant administration received mechanical compression, with (very high risk) or without (high risk) possible temporary IVC filter (prn as determined by caregiver).
1113091|NCT00531843|B1|Baseline|Fondaparinux Sodium|Patients at high risk or very high risk for venous thromboembolism received fondaparinux 2.5mg SubQ daily, with (very high risk) or without (high risk) mechanical compression upon admission or by 3rd day after injury.
1113092|NCT00531843|P2|Participant Flow|No Fondaparinux|Patients at high risk or very high risk for venous thromboembolism AND contraindication to anticoagulant administration received mechanical compression, with (very high risk) or without (high risk) possible temporary inferior vena cava (IVC) filter (prn as determined by caregiver).
1113093|NCT00531843|P1|Participant Flow|Fondaparinux Sodium|Patients at high risk or very high risk for venous thromboembolism received fondaparinux 2.5mg via subcutaneous administration (SubQ) daily, with (very high risk) or without (high risk) mechanical compression upon admission or by 3rd day after injury.
1113094|NCT00531843|O2|Outcome|No Fondaparinux|Patients at high risk or very high risk for venous thromboembolism AND contraindication to anticoagulant administration received mechanical compression, with (very high risk) or without (high risk) possible temporary IVC filter (prn as determined by caregiver).
1113095|NCT00531843|O1|Outcome|Fondaparinux Sodium|Patients at high risk or very high risk for venous thromboembolism received fondaparinux 2.5mg SubQ daily, with (very high risk) or without (high risk) mechanical compression upon admission or by 3rd day after injury.
1113096|NCT00531843|O2|Outcome|No Fondaparinux|Patients at high risk or very high risk for venous thromboembolism AND contraindication to anticoagulant administration received mechanical compression, with (very high risk) or without (high risk) possible temporary IVC filter (prn as determined by caregiver).
1113097|NCT00531843|O1|Outcome|Fondaparinux Sodium|Patients at high risk or very high risk for venous thromboembolism received fondaparinux 2.5mg SubQ daily, with (very high risk) or without (high risk) mechanical compression upon admission or by 3rd day after injury.
1113098|NCT00531843|O2|Outcome|No Fondaparinux|Patients at high risk or very high risk for venous thromboembolism AND contraindication to anticoagulant administration received mechanical compression, with (very high risk) or without (high risk) possible temporary IVC filter (prn as determined by caregiver).
1113099|NCT00531843|O1|Outcome|Fondaparinux Sodium|Patients at high risk or very high risk for venous thromboembolism received fondaparinux 2.5mg SubQ daily, with (very high risk) or without (high risk) mechanical compression upon admission or by 3rd day after injury.
1113100|NCT00531843|E2|Reported Event|No Fondaparinux|Patients at high risk or very high risk for venous thromboembolism AND contraindication to anticoagulant administration received mechanical compression, with (very high risk) or without (high risk) possible temporary IVC filter (prn as determined by caregiver).
1113101|NCT00531843|E1|Reported Event|Fondaparinux Sodium|Patients at high risk or very high risk for venous thromboembolism received fondaparinux 2.5mg SubQ daily, with (very high risk) or without (high risk) mechanical compression upon admission or by 3rd day after injury.
1113102|NCT00531817|B3|Baseline|Total|Total of all reporting groups
1113103|NCT00531817|B2|Baseline|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
1113104|NCT00531817|B1|Baseline|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
1113105|NCT00531817|P2|Participant Flow|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
1113106|NCT00531817|P1|Participant Flow|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
1113107|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
1113813|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113112|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
1113113|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
1113114|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
1113115|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
1113116|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
1113117|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
1113118|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
1113119|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
1113120|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
1113121|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
1113122|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
1113123|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
1113124|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
1113125|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
1113765|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113126|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
1113127|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
1113128|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
1113129|NCT00531817|E3|Reported Event|Placebo + DMARDs|Initially treated with placebo + DMARDs and received ≥ 1 dose of placebo. The placebo + DMARDs group includes all data collected while patients were on placebo for those who were initially treated with placebo in the double-blind treatment period.
1113130|NCT00531817|E2|Reported Event|Placebo/Tocilizumab + DMARDs|Initially treated with placebo + DMARDs then received ≥ 1 dose of tocilizumab. The placebo/tocilizumab + DMARDs group includes all data collected after patients’ first infusion of tocilizumab (whether escape therapy or extended treatment) for those who were initially treated with placebo in the double-blind treatment period. In the extended treatment period, patients received tocilizumab 8 mg/kg 1-hour IV infusion every 4 weeks (q4weeks) for up to 1 month post-commercial availability of tocilizumab in the United States.
1113131|NCT00531817|E1|Reported Event|Tocilizumab + DMARDs|Initially treated with tocilizumab + DMARDs and received ≥ 1 dose of tocilizumab. The tocilizumab + DMARDs group includes all data (double-blind and extended treatment periods) for patients who were initially treated with tocilizumab in the double-blind treatment period. In the extended treatment period, patients received tocilizumab 8 mg/kg 1-hour IV infusion every 4 weeks (q4weeks) for up to 1 month post-commercial availability of tocilizumab in the United States.
1113132|NCT00531752|B5|Baseline|Total|Total of all reporting groups
1113133|NCT00531752|B4|Baseline|PF-03654746 (Flexible Dose) First, Then Placebo|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator's discretion and tolerability, in the first DB intervention period and then placebo matched to PF-03654746 capsule orally once daily in the second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
1113134|NCT00531752|B3|Baseline|Placebo First, Then PF-03654746 (Flexible Dose)|Placebo matched to PF-03654746 capsule orally once daily in the first DB intervention period and then PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator's discretion and tolerability, in the second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
1113135|NCT00531752|B2|Baseline|PF-03654746 (Low Dose) First, Then Placebo|Low dose of PF-03654746 capsule 1 mg orally once daily for 3 weeks in first DB intervention period and then placebo matched to PF-03654746 capsule orally once daily for 3 weeks in second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
1113136|NCT00531752|B1|Baseline|Placebo First, Then PF-03654746 (Low Dose)|Placebo matched to PF-03654746 capsule orally once daily for 3 weeks in first double-blind (DB) intervention period and then low dose of PF-03654746 capsule 1 milligram (mg) orally once daily for 3 weeks in second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
1113137|NCT00531752|P4|Participant Flow|PF-03654746 (Flexible Dose) First, Then Placebo|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in the first DB intervention period and then placebo matched to PF-03654746 capsule orally once daily in the second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
1113138|NCT00531752|P3|Participant Flow|Placebo First, Then PF-03654746 (Flexible Dose)|Placebo matched to PF-03654746 capsule orally once daily in the first DB intervention period and then PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in the second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
1113171|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
1122447|NCT00510484|O1|Outcome|Pancrelipase|
1113139|NCT00531752|P2|Participant Flow|PF-03654746 (Low Dose) First, Then Placebo|Low dose of PF-03654746 capsule 1 mg orally once daily for 3 weeks in first DB intervention period and then placebo matched to PF-03654746 capsule orally once daily for 3 weeks in second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
1113140|NCT00531752|P1|Participant Flow|Placebo First, Then PF-03654746 (Low Dose)|Placebo matched to PF-03654746 capsule orally once daily for 3 weeks in first double-blind (DB) intervention period and then low dose of PF-03654746 capsule 1 milligram (mg) orally once daily for 3 weeks in second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
1113141|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
1113142|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
1113143|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
1113144|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
1113145|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
1113146|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
1113147|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
1113148|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
1113149|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
1113150|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
1113151|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
1113152|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
1113153|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
1113154|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
1113155|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
1113156|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
1113157|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
1113158|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
1113159|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
1113160|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
1113161|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
1113162|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
1113163|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
1113164|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
1113165|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
1113166|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
1113167|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
1113168|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
1113169|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
1113170|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
1113172|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
1113173|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
1113174|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
1113175|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
1113176|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
1113177|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
1113178|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
1113179|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
1113180|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
1113245|NCT00531518|O1|Outcome|Control|This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.
1113181|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
1113182|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
1113183|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
1113184|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
1113185|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
1113186|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
1113187|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
1113188|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
1113189|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
1113190|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
1113191|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
1113192|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
1113193|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
1113194|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
1113195|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
1113196|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
1113197|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
1113198|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
1113199|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
1113200|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
1113201|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
1113202|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
1113203|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
1113204|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
1122448|NCT00510484|E2|Reported Event|Placebo|
1113205|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
1113206|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
1113207|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
1113208|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
1113209|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
1113210|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
1113211|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
1113212|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
1113213|NCT00531752|E3|Reported Event|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
1113214|NCT00531752|E2|Reported Event|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
1113215|NCT00531752|E1|Reported Event|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
1113216|NCT00531661|B3|Baseline|Total|Total of all reporting groups
1113217|NCT00531661|B2|Baseline|Control|CONTROL group: standard of care HF management
1113218|NCT00531661|B1|Baseline|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
1113219|NCT00531661|P2|Participant Flow|Control|CONTROL group: standard of care HF management
1113220|NCT00531661|P1|Participant Flow|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
1113221|NCT00531661|O1|Outcome|Full Duration Study Cohort|Safety endpoint evaluated for all patients having follow-up after the 6-month primary period.
1113222|NCT00531661|O1|Outcome|Full Duration Study Cohort|Safety endpoint evaluated for all patients having follow-up after the 6-month primary period.
1113223|NCT00531661|O2|Outcome|Control|CONTROL group: standard of care HF management
1113224|NCT00531661|O1|Outcome|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
1113225|NCT00531661|O2|Outcome|Control|CONTROL group: standard of care HF management
1113226|NCT00531661|O1|Outcome|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
1113227|NCT00531661|O2|Outcome|Control|CONTROL group: standard of care HF management
1113228|NCT00531661|O1|Outcome|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
1113229|NCT00531661|O2|Outcome|Control|CONTROL group: standard of care HF management
1113230|NCT00531661|O1|Outcome|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
1113231|NCT00531661|O2|Outcome|Control|CONTROL group: standard of care HF management
1113232|NCT00531661|O1|Outcome|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
1113233|NCT00531661|O1|Outcome|Entire Randomized Study Cohort|
1113234|NCT00531661|O1|Outcome|Entire Study Cohort|
1113235|NCT00531661|O2|Outcome|Control|CONTROL group: standard of care HF management
1113236|NCT00531661|O1|Outcome|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
1113237|NCT00531661|E2|Reported Event|Control|CONTROL group: standard of care HF management
1113238|NCT00531661|E1|Reported Event|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
1113239|NCT00531518|B3|Baseline|Total|Total of all reporting groups
1113240|NCT00531518|B2|Baseline|Experimental Intervention|"This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .~aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations~Psychoeducational multifamily group treatment: Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work~Supported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals."
1113241|NCT00531518|B1|Baseline|Control Group|This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.
1113279|NCT00531453|E1|Reported Event|Three Drug Regimen (VDT)|bortezomib, dexamethasone, and thalidomide
1113280|NCT00531427|B3|Baseline|Total|Total of all reporting groups
1113281|NCT00531427|B2|Baseline|Double-blind Placebo|Placebo patches to match the BTDS patches applied for 7-day wear
1113242|NCT00531518|P2|Participant Flow|Family-aided Assertive Community Treatment|"This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .~aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations~Psychoeducational multifamily group treatment: Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work~Supported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals."
1113243|NCT00531518|P1|Participant Flow|Control Group|This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.
1113244|NCT00531518|O2|Outcome|Family-aided Assertive Community Treatment|"This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .~aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations~Psychoeducational multifamily group treatment: Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work~Supported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals."
1113294|NCT00531284|B18|Baseline|Total|Total of all reporting groups
1113246|NCT00531518|E2|Reported Event|Family-aided Assertive Community Treatment|"This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .~aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations~Psychoeducational multifamily group treatment: Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work~Supported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals."
1113247|NCT00531518|E1|Reported Event|Control Group|This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.
1113248|NCT00531479|B3|Baseline|Total|Total of all reporting groups
1113249|NCT00531479|B2|Baseline|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
1113250|NCT00531479|B1|Baseline|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
1113251|NCT00531479|P2|Participant Flow|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
1113252|NCT00531479|P1|Participant Flow|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
1113253|NCT00531479|O2|Outcome|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
1113254|NCT00531479|O1|Outcome|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
1113255|NCT00531479|O2|Outcome|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
1113256|NCT00531479|O1|Outcome|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
1122449|NCT00510484|E1|Reported Event|Pancrelipase|
1113257|NCT00531479|O2|Outcome|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
1113258|NCT00531479|O1|Outcome|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
1113259|NCT00531479|O2|Outcome|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
1113260|NCT00531479|O1|Outcome|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
1116927|NCT00524264|P2|Participant Flow|Vehicle Solution|
1113261|NCT00531479|O2|Outcome|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
1113262|NCT00531479|O1|Outcome|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
1113263|NCT00531479|O2|Outcome|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
1113264|NCT00531479|O1|Outcome|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
1113265|NCT00531479|O2|Outcome|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
1113266|NCT00531479|O1|Outcome|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
1113267|NCT00531479|E2|Reported Event|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
1113268|NCT00531479|E1|Reported Event|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
1113269|NCT00531453|B3|Baseline|Total|Total of all reporting groups
1113270|NCT00531453|B2|Baseline|Four Drug Regimen (VDTC)|bortezomib, dexamethasone, thalidomide, and cyclophosphamide
1113271|NCT00531453|B1|Baseline|Three Drug Regimen (VDT)|bortezomib, dexamethasone, and thalidomide
1113272|NCT00531453|P2|Participant Flow|Four Drug Regimen (VDTC)|bortezomib, dexamethasone, thalidomide, and cyclophosphamide
1113273|NCT00531453|P1|Participant Flow|Three Drug Regimen (VDT)|bortezomib, dexamethasone, and thalidomide
1113274|NCT00531453|O2|Outcome|Four Drug Regimen (VDTC)|bortezomib, dexamethasone, thalidomide, and cyclophosphamide
1113275|NCT00531453|O1|Outcome|Three Drug Regimen (VDT)|bortezomib, dexamethasone, and thalidomide
1113276|NCT00531453|O2|Outcome|Four Drug Regimen (VDTC)|bortezomib, dexamethasone, thalidomide, and cyclophosphamide
1113277|NCT00531453|O1|Outcome|Three Drug Regimen (VDT)|bortezomib, dexamethasone, and thalidomide
1113278|NCT00531453|E2|Reported Event|Four Drug Regimen (VDTC)|bortezomib, dexamethasone, thalidomide, and cyclophosphamide
1113282|NCT00531427|B1|Baseline|Double-blind BTDS 10 or 20|Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear
1113283|NCT00531427|P2|Participant Flow|Double-blind Placebo|Placebo patches to match the BTDS patches applied for 7-day wear
1113284|NCT00531427|P1|Participant Flow|Double-blind BTDS 10 or 20|Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear
1113285|NCT00531427|O2|Outcome|Double-blind Placebo|Placebo patches to match the BTDS patches applied for 7-day wear
1113286|NCT00531427|O1|Outcome|Double-blind BTDS 10 or 20|Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear
1113287|NCT00531427|O2|Outcome|Double-blind Placebo|Placebo patches to match the BTDS patches applied for 7-day wear
1113288|NCT00531427|O1|Outcome|Double-blind BTDS 10 or 20|Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear
1113289|NCT00531427|O2|Outcome|Double-blind Placebo|Placebo patches to match the BTDS patches applied for 7-day wear
1113290|NCT00531427|O1|Outcome|Double-blind BTDS 10 or 20|Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear
1113291|NCT00531427|E3|Reported Event|Open-label Run-in Period|The open-label run-in period was designed with duration of time sufficient to select those subjects who both tolerated and responded to treatment with BTDS 10 or BTDS 20 (an enriched design). During this period, subjects were required to discontinue use of all nonstudy drugs used for the treatment of chronic pain and no supplemental analgesic medications were allowed. Subjects who did not tolerate BTDS 5 were discontinued from the study.
1113292|NCT00531427|E2|Reported Event|Double-blind Placebo|Placebo patches to match the BTDS patches applied for 7-day wear
1113293|NCT00531427|E1|Reported Event|Double-blind BTDS|Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear
1113295|NCT00531284|B17|Baseline|P1B MM: CFZ 20/56 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113296|NCT00531284|B16|Baseline|P1B MM: CFZ 20/45 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113297|NCT00531284|B15|Baseline|P1B LYM: CFZ 20/70 mg/m²|Participants with lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113298|NCT00531284|B14|Baseline|P1B LYM: CFZ 20/56 mg/m²|Participants with lymphoma (LYM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113299|NCT00531284|B13|Baseline|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113300|NCT00531284|B12|Baseline|P1b MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113301|NCT00531284|B11|Baseline|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113302|NCT00531284|B10|Baseline|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113303|NCT00531284|B9|Baseline|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113304|NCT00531284|B8|Baseline|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113305|NCT00531284|B7|Baseline|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113306|NCT00531284|B6|Baseline|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113498|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
1113307|NCT00531284|B5|Baseline|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113308|NCT00531284|B4|Baseline|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113309|NCT00531284|B3|Baseline|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113310|NCT00531284|B2|Baseline|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113311|NCT00531284|B1|Baseline|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113766|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113312|NCT00531284|P17|Participant Flow|P1B MM: CFZ 20/56 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113313|NCT00531284|P16|Participant Flow|P1B MM: CFZ 20/45 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113314|NCT00531284|P15|Participant Flow|P1B LYM: CFZ 20/70 mg/m²|Participants with lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113315|NCT00531284|P14|Participant Flow|P1B LYM: CFZ 20/56 mg/m²|Participants with lymphoma (LYM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113316|NCT00531284|P13|Participant Flow|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113317|NCT00531284|P12|Participant Flow|P1b MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113318|NCT00531284|P11|Participant Flow|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113319|NCT00531284|P10|Participant Flow|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113320|NCT00531284|P9|Participant Flow|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113321|NCT00531284|P8|Participant Flow|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113322|NCT00531284|P7|Participant Flow|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113323|NCT00531284|P6|Participant Flow|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113356|NCT00531284|O3|Outcome|ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
1113324|NCT00531284|P5|Participant Flow|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113325|NCT00531284|P4|Participant Flow|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113326|NCT00531284|P3|Participant Flow|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113327|NCT00531284|P2|Participant Flow|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113365|NCT00531284|O4|Outcome|ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
1113366|NCT00531284|O3|Outcome|ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
1113328|NCT00531284|P1|Participant Flow|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113329|NCT00531284|O5|Outcome|MM: CFZ 20 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
1113330|NCT00531284|O4|Outcome|ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
1113331|NCT00531284|O3|Outcome|ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
1113332|NCT00531284|O2|Outcome|ST: CFZ 20 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
1113333|NCT00531284|O1|Outcome|ST: CFZ 20 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
1113334|NCT00531284|O5|Outcome|MM: CFZ 20 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
1113335|NCT00531284|O4|Outcome|ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
1113336|NCT00531284|O3|Outcome|ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
1113337|NCT00531284|O2|Outcome|ST: CFZ 20 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
1113338|NCT00531284|O1|Outcome|ST: CFZ 20 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
1113339|NCT00531284|O5|Outcome|MM: CFZ 20 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
1113340|NCT00531284|O4|Outcome|ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
1113341|NCT00531284|O3|Outcome|ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
1113342|NCT00531284|O2|Outcome|ST: CFZ 20 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
1113343|NCT00531284|O1|Outcome|ST: CFZ 20 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
1113344|NCT00531284|O5|Outcome|MM: CFZ 20 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
1113345|NCT00531284|O4|Outcome|ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
1113346|NCT00531284|O3|Outcome|ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
1113347|NCT00531284|O2|Outcome|ST: CFZ 20 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
1113348|NCT00531284|O1|Outcome|ST: CFZ 20 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
1113349|NCT00531284|O5|Outcome|MM: CFZ 20 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
1113350|NCT00531284|O4|Outcome|ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
1113351|NCT00531284|O3|Outcome|ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
1113352|NCT00531284|O2|Outcome|ST: CFZ 20 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
1113353|NCT00531284|O1|Outcome|ST: CFZ 20 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
1113354|NCT00531284|O5|Outcome|MM: CFZ 20 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
1113355|NCT00531284|O4|Outcome|ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
1113539|NCT00531011|B3|Baseline|Total|Total of all reporting groups
1113357|NCT00531284|O2|Outcome|ST: CFZ 20 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
1113358|NCT00531284|O1|Outcome|ST: CFZ 20 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
1113359|NCT00531284|O5|Outcome|MM: CFZ 20 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
1113360|NCT00531284|O4|Outcome|ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
1113361|NCT00531284|O3|Outcome|ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
1113362|NCT00531284|O2|Outcome|ST: CFZ 20 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
1113363|NCT00531284|O1|Outcome|ST: CFZ 20 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
1113364|NCT00531284|O5|Outcome|MM: CFZ 20 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
1113605|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
1113367|NCT00531284|O2|Outcome|ST: CFZ 20 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
1113368|NCT00531284|O1|Outcome|ST: CFZ 20 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
1113369|NCT00531284|O19|Outcome|P1B MM: CFZ 20/56 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113370|NCT00531284|O18|Outcome|P1B MM: CFZ 20/45 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113371|NCT00531284|O17|Outcome|P1B WM: CFZ 20/70 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113372|NCT00531284|O16|Outcome|P1B WM: CFZ 20/56 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113373|NCT00531284|O15|Outcome|P1B NHL: CFZ 20/70 mg/m²|Participants with non-Hodgkin's lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113374|NCT00531284|O14|Outcome|P1B NHL: CFZ 20/56 mg/m²|Participants with non-Hodgkin's lymphoma (NHL) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113375|NCT00531284|O13|Outcome|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113376|NCT00531284|O12|Outcome|P1b MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113377|NCT00531284|O11|Outcome|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113378|NCT00531284|O10|Outcome|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113379|NCT00531284|O9|Outcome|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113493|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
1113814|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113380|NCT00531284|O8|Outcome|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113381|NCT00531284|O7|Outcome|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113382|NCT00531284|O6|Outcome|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113383|NCT00531284|O5|Outcome|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113548|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
1113549|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
1113384|NCT00531284|O4|Outcome|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113385|NCT00531284|O3|Outcome|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113386|NCT00531284|O2|Outcome|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113387|NCT00531284|O1|Outcome|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113388|NCT00531284|O19|Outcome|P1B MM: CFZ 20/56 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113389|NCT00531284|O18|Outcome|P1B MM: CFZ 20/45 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113390|NCT00531284|O17|Outcome|P1B WM: CFZ 20/70 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113391|NCT00531284|O16|Outcome|P1B WM: CFZ 20/56 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113392|NCT00531284|O15|Outcome|P1B NHL: CFZ 20/70 mg/m²|Participants with non-Hodgkin's lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113393|NCT00531284|O14|Outcome|P1B NHL: CFZ 20/56 mg/m²|Participants with non-Hodgkin's lymphoma (NHL) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113394|NCT00531284|O13|Outcome|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113395|NCT00531284|O12|Outcome|P1b MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113396|NCT00531284|O11|Outcome|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113494|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
1113397|NCT00531284|O10|Outcome|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113398|NCT00531284|O9|Outcome|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113399|NCT00531284|O8|Outcome|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113550|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
1113551|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
1113400|NCT00531284|O7|Outcome|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113401|NCT00531284|O6|Outcome|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113402|NCT00531284|O5|Outcome|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113403|NCT00531284|O4|Outcome|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113404|NCT00531284|O3|Outcome|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113405|NCT00531284|O2|Outcome|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113406|NCT00531284|O1|Outcome|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113407|NCT00531284|O19|Outcome|P1B MM: CFZ 20/56 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113408|NCT00531284|O18|Outcome|P1B MM: CFZ 20/45 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113409|NCT00531284|O17|Outcome|P1B WM: CFZ 20/70 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113410|NCT00531284|O16|Outcome|P1B WM: CFZ 20/56 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113411|NCT00531284|O15|Outcome|P1B NHL: CFZ 20/70 mg/m²|Participants with non-Hodgkin's lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113412|NCT00531284|O14|Outcome|P1B NHL: CFZ 20/56 mg/m²|Participants with non-Hodgkin's lymphoma (NHL) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113413|NCT00531284|O13|Outcome|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113495|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
1113414|NCT00531284|O12|Outcome|P1b MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113415|NCT00531284|O11|Outcome|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113416|NCT00531284|O10|Outcome|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113417|NCT00531284|O9|Outcome|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113418|NCT00531284|O8|Outcome|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113419|NCT00531284|O7|Outcome|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113420|NCT00531284|O6|Outcome|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113421|NCT00531284|O5|Outcome|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113422|NCT00531284|O4|Outcome|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113423|NCT00531284|O3|Outcome|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113424|NCT00531284|O2|Outcome|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113425|NCT00531284|O1|Outcome|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113426|NCT00531284|O19|Outcome|P1B MM: CFZ 20/56 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113427|NCT00531284|O18|Outcome|P1B MM: CFZ 20/45 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113428|NCT00531284|O17|Outcome|P1B WM: CFZ 20/70 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113429|NCT00531284|O16|Outcome|P1B WM: CFZ 20/56 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113430|NCT00531284|O15|Outcome|P1B NHL: CFZ 20/70 mg/m²|Participants with non-Hodgkin's lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113496|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
1113431|NCT00531284|O14|Outcome|P1B NHL: CFZ 20/56 mg/m²|Participants with non-Hodgkin's lymphoma (NHL) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113432|NCT00531284|O13|Outcome|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113433|NCT00531284|O12|Outcome|P1b MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113434|NCT00531284|O11|Outcome|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113435|NCT00531284|O10|Outcome|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113436|NCT00531284|O9|Outcome|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113437|NCT00531284|O8|Outcome|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113438|NCT00531284|O7|Outcome|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113439|NCT00531284|O6|Outcome|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113440|NCT00531284|O5|Outcome|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113441|NCT00531284|O4|Outcome|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113442|NCT00531284|O3|Outcome|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113443|NCT00531284|O2|Outcome|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113444|NCT00531284|O1|Outcome|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113445|NCT00531284|O1|Outcome|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment.
1113446|NCT00531284|O14|Outcome|P1B LYM: CFZ 20/70 mg/m²|Participants with lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113447|NCT00531284|O13|Outcome|P1B LYM: CFZ 20/56 mg/m²|Participants with lymphoma (LYM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113448|NCT00531284|O12|Outcome|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113449|NCT00531284|O11|Outcome|P1b MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113450|NCT00531284|O10|Outcome|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113451|NCT00531284|O9|Outcome|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113452|NCT00531284|O8|Outcome|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113453|NCT00531284|O7|Outcome|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113454|NCT00531284|O6|Outcome|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113455|NCT00531284|O5|Outcome|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113456|NCT00531284|O4|Outcome|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113457|NCT00531284|O3|Outcome|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113458|NCT00531284|O2|Outcome|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113459|NCT00531284|O1|Outcome|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113460|NCT00531284|E17|Reported Event|P1B MM: CFZ 20/56 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113461|NCT00531284|E16|Reported Event|P1B MM: CFZ 20/45 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113462|NCT00531284|E15|Reported Event|P1B LYM: CFZ 20/70 mg/m²|Participants with lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113463|NCT00531284|E14|Reported Event|P1B LYM: CFZ 20/56 mg/m²|Participants with lymphoma (LYM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113464|NCT00531284|E13|Reported Event|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113465|NCT00531284|E12|Reported Event|P1B MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113497|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
1122796|NCT00509873|E2|Reported Event|Placebo Eye Drops|Placebo eye drops
1113466|NCT00531284|E11|Reported Event|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113467|NCT00531284|E10|Reported Event|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113468|NCT00531284|E9|Reported Event|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113469|NCT00531284|E8|Reported Event|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113470|NCT00531284|E7|Reported Event|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113471|NCT00531284|E6|Reported Event|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113472|NCT00531284|E5|Reported Event|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113473|NCT00531284|E4|Reported Event|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113474|NCT00531284|E3|Reported Event|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113475|NCT00531284|E2|Reported Event|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113476|NCT00531284|E1|Reported Event|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
1113477|NCT00531206|B1|Baseline|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
1113478|NCT00531206|P1|Participant Flow|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
1113479|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
1113480|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
1113481|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
1113482|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
1113483|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
1113484|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
1113485|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
1113486|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
1113487|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
1113488|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
1113489|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
1113490|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
1113491|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
1113492|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
1123355|NCT00508001|B4|Baseline|Total|Total of all reporting groups
1113499|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
1113500|NCT00531206|E1|Reported Event|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
1113501|NCT00531050|B7|Baseline|Total|Total of all reporting groups
1113520|NCT00531050|O3|Outcome|Part 2:Placebo Morning/Placebo Evening|Patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
1113552|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
1113553|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
1113502|NCT00531050|B6|Baseline|Part 1: Sequence F, Part 2: Sequence F|"Part 1: Sequence 'F' consisted of - Period 1, patient received single dose of salmeterol 50μg via Diskus DPI. Period 2, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device.~Part 2: Sequence 'F' consisted of - Period 1, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 2, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 3, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
1113503|NCT00531050|B5|Baseline|Part 1: Sequence E, Part 2: Sequence E|"Part 1: Sequence 'E' consisted of - Period 1, patient received single dose of salmeterol 50μg via Diskus DPI. Period 2, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 3, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device.~Part 2: Sequence 'E' consisted of - Period 1, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 2, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
1113504|NCT00531050|B4|Baseline|Part 1; Sequence D, Part 2: Sequence D|"Part 1: Sequence 'D' consisted of - Period 1, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 3, patient received single dose of salmeterol 50μg via Diskus DPI.~Part 2: Sequence 'D' consisted of - Period 1, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 2, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
1113505|NCT00531050|B3|Baseline|Part 1: Sequence C, Part 2: Sequence C|"Part 1: Sequence 'C' consisted of - Period 1, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patient received single dose of salmeterol 50μg via Diskus DPI. Period 3, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device.~Part 2: Sequence 'C' consisted of - Period 1, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 2, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 3, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device . In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
1113506|NCT00531050|B2|Baseline|Part 1 : Sequence B, Part 2: Sequence B|"Part 1: Sequence 'B' consisted of - Period 1, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 2, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patient received single dose of salmeterol 50μg via Diskus DPI.~Part 2: Sequence 'B' consisted of - Period 1, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 3, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
1113507|NCT00531050|B1|Baseline|Part 1: Sequence A, Part 2: Sequence A|"Part 1: Sequence 'A' consisted of - Period 1, patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. Period 2, patient received single dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). Period 3, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device.~Part 2: Sequence 'A' consisted of - Period 1, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 3, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
1113508|NCT00531050|P6|Participant Flow|Part 1: Sequence F, Part 2: Sequence F|"Part 1: Sequence 'F' consisted of - Period 1, patient received single dose of salmeterol 50μg via Diskus DPI. Period 2, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device.~Part 2: Sequence 'F' consisted of - Period 1, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 2, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 3, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
1113540|NCT00531011|B2|Baseline|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
1113541|NCT00531011|B1|Baseline|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
1113546|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
1113547|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
1113763|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113509|NCT00531050|P5|Participant Flow|Part 1: Sequence E, Part 2: Sequence E|"Part 1: Sequence 'E' consisted of - Period 1, patient received single dose of salmeterol 50μg via Diskus DPI. Period 2, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 3, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device.~Part 2: Sequence 'E' consisted of - Period 1, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 2, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
1113510|NCT00531050|P4|Participant Flow|Part 1; Sequence D, Part 2: Sequence D|"Part 1: Sequence 'D' consisted of - Period 1, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 3, patient received single dose of salmeterol 50μg via Diskus DPI.~Part 2: Sequence 'D' consisted of - Period 1, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 2, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
1113511|NCT00531050|P3|Participant Flow|Part 1: Sequence C, Part 2: Sequence C|"Part 1: Sequence 'C' consisted of - Period 1, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patient received single dose of salmeterol 50μg via Diskus DPI. Period 3, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device.~Part 2: Sequence 'C' consisted of - Period 1, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 2, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 3, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device . In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
1113512|NCT00531050|P2|Participant Flow|Part 1 : Sequence B, Part 2: Sequence B|"Part 1: Sequence 'B' consisted of - Period 1, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 2, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patient received single dose of salmeterol 50μg via Diskus DPI.~Part 2: Sequence 'B' consisted of - Period 1, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 3, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
1113513|NCT00531050|P1|Participant Flow|Part 1: Sequence A, Part 2: Sequence A|"Part 1: Sequence 'A' consisted of - Period 1, patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. Period 2, patient received single dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). Period 3, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device.~Part 2: Sequence 'A' consisted of - Period 1, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 3, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
1113514|NCT00531050|O6|Outcome|Part 2:Placebo Morning/Placebo Evening|Patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
1113515|NCT00531050|O5|Outcome|Part 2:Salmeterol 50μg Morning/Salmeterol 50μg Evening|Patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
1113516|NCT00531050|O4|Outcome|Part 2:Indacaterol 300μg Morning/Placebo Evening|Patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
1113517|NCT00531050|O3|Outcome|Part 1: Placebo|Patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
1113518|NCT00531050|O2|Outcome|Part 1 : Salmeterol 50μg|Patient received single dose of salmeterol 50μg via Diskus DPI. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
1113519|NCT00531050|O1|Outcome|Part 1: Indacaterol 300μg|Patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
1113542|NCT00531011|P2|Participant Flow|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
1113521|NCT00531050|O2|Outcome|Part 2:Salmeterol 50μg Morning/Salmeterol 50μg Evening|Patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
1113522|NCT00531050|O1|Outcome|Part 2:Indacaterol 300μg Morning/Placebo Evening|Patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
1113523|NCT00531050|O3|Outcome|Part 1: Placebo|Patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
1113524|NCT00531050|O2|Outcome|Part 1 : Salmeterol 50μg|Patient received single dose of salmeterol 50μg via Diskus DPI. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
1113525|NCT00531050|O1|Outcome|Part 1: Indacaterol 300μg|Patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
1113526|NCT00531050|O2|Outcome|Part 2:Salmeterol 50μg Morning/Salmeterol 50μg Evening|Patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
1113527|NCT00531050|O1|Outcome|Part 2:Indacaterol 300μg Morning/Placebo Evening|Patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
1113528|NCT00531050|O3|Outcome|Part 1: Placebo|Patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
1113529|NCT00531050|O2|Outcome|Part 1 : Salmeterol 50μg|Patient received single dose of salmeterol 50μg via Diskus DPI. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
1113530|NCT00531050|O1|Outcome|Part 1: Indacaterol 300μg|Patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
1113531|NCT00531050|O2|Outcome|Part 1 : Salmeterol 50μg|Patient received single dose of salmeterol 50μg via Diskus DPI. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
1113532|NCT00531050|O1|Outcome|Part 1: Indacaterol 300μg|Patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
1113533|NCT00531050|E6|Reported Event|Part 2:Placebo Morning/Placebo Evening|Patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
1113534|NCT00531050|E5|Reported Event|Part 2:Salmeterol AM 50mcg/Salmeterol PM 50mcg|Patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
1113535|NCT00531050|E4|Reported Event|Part 2:Indacaterol 300μg Morning/Placebo Evening|Patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
1113536|NCT00531050|E3|Reported Event|Part 1:Placebo|Patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
1113537|NCT00531050|E2|Reported Event|Part 1:Salmeterol 50mcg|Patient received single dose of salmeterol 50μg via Diskus DPI. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
1113538|NCT00531050|E1|Reported Event|Part 1:Indacaterol 300mcg|Patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
1113543|NCT00531011|P1|Participant Flow|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
1113544|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
1113545|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
1113554|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
1113555|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
1113556|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
1113557|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
1113558|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
1113559|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
1113560|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
1113561|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
1113562|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
1113563|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
1113564|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
1113565|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
1113566|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
1113567|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
1113568|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
1113569|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
1113570|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
1113571|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
1113572|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
1113573|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
1113574|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
1113575|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
1113576|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
1113577|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
1113578|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
1113579|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
1113580|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
1113581|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
1113582|NCT00531011|E2|Reported Event|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
1113583|NCT00531011|E1|Reported Event|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
1113584|NCT00530946|B5|Baseline|Total|Total of all reporting groups
1113585|NCT00530946|B4|Baseline|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
1113586|NCT00530946|B3|Baseline|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
1113587|NCT00530946|B2|Baseline|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
1113588|NCT00530946|B1|Baseline|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
1113589|NCT00530946|P4|Participant Flow|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
1113590|NCT00530946|P3|Participant Flow|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
1113591|NCT00530946|P2|Participant Flow|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
1113592|NCT00530946|P1|Participant Flow|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
1113593|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
1113594|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
1113595|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
1113596|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
1113597|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
1113598|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
1113599|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
1113600|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
1113601|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
1113602|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
1113606|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
1113607|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
1113608|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
1113609|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
1113610|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
1113611|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
1113612|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
1113613|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
1113614|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
1113615|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
1113616|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
1113617|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
1113618|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
1113619|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
1113620|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
1113621|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
1113622|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
1113623|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
1113624|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
1113625|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
1113626|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
1113627|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
1113628|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
1113629|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
1113630|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
1113631|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
1113632|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
1113633|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
1113634|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
1113635|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
1113636|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
1113637|NCT00530946|E4|Reported Event|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
1113638|NCT00530946|E3|Reported Event|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
1113639|NCT00530946|E2|Reported Event|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
1113640|NCT00530946|E1|Reported Event|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
1113641|NCT00530920|B4|Baseline|Total|Total of all reporting groups
1123356|NCT00508001|B3|Baseline|Placebo|Placebo plus Best Support Care
1113642|NCT00530920|B3|Baseline|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
1113643|NCT00530920|B2|Baseline|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
1113644|NCT00530920|B1|Baseline|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
1113645|NCT00530920|P3|Participant Flow|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
1113646|NCT00530920|P2|Participant Flow|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given once daily
1113647|NCT00530920|P1|Participant Flow|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
1113648|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
1113649|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
1113650|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
1113651|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
1113652|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
1113653|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
1113654|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
1113655|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
1113656|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
1113657|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
1113658|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
1113659|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
1113660|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
1113661|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
1113662|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
1113663|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
1113664|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
1113665|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
1113666|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
1113667|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
1113668|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
1113669|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
1113670|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
1113671|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
1113672|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
1113673|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
1113674|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
1113675|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
1113676|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
1113677|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
1113678|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
1113679|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
1113680|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
1113681|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
1113682|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
1113683|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
1113684|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
1113685|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
1113686|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
1113687|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
1113688|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
1113689|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
1113690|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
1113691|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
1113692|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
1113693|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
1113694|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
1113695|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
1113696|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
1113697|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
1113698|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
1113699|NCT00530920|E3|Reported Event|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
1113700|NCT00530920|E2|Reported Event|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
1113701|NCT00530920|E1|Reported Event|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
1113702|NCT00530894|B5|Baseline|Total|Total of all reporting groups
1113703|NCT00530894|B4|Baseline|Inoperable: Medical Therapy|Medical management and/or balloon aortic valvuloplasty
1113704|NCT00530894|B3|Baseline|Inoperable TAVR|Edwards SAPIEN Transcatheter Heart Valve
1113705|NCT00530894|B2|Baseline|High Risk: SAVR|Surgical Valve Replacement
1113706|NCT00530894|B1|Baseline|High Risk: TAVR|Edwards SAPIEN Transcatheter Heart Valve
1113707|NCT00530894|P4|Participant Flow|Inoperable: Medical Therapy|Medical management and/or balloon aortic valvuloplasty
1113708|NCT00530894|P3|Participant Flow|Inoperable: TAVR|Edwards SAPIEN Transcatheter Heart Valve
1113709|NCT00530894|P2|Participant Flow|High Risk: SAVR|Surgical Aortic Valve Replacement
1113710|NCT00530894|P1|Participant Flow|High Risk: TAVR|Edwards SAPIEN Transcatheter Heart Valve
1113711|NCT00530894|O4|Outcome|Inoperable: Medical Therapy|Medical management and/or balloon aortic valvuloplasty
1113712|NCT00530894|O3|Outcome|Inoperable: TAVR|Edwards SAPIEN Transcatheter Heart Valve
1113713|NCT00530894|O2|Outcome|High Risk: SAVR|Surgical Aortic Valve Replacement
1113714|NCT00530894|O1|Outcome|High Risk: TAVR|Edwards SAPIEN Transcatheter Heart Valve
1113715|NCT00530894|O4|Outcome|Inoperable: Medical Therapy|Medical management and/or balloon aortic valvuloplasty
1113716|NCT00530894|O3|Outcome|Inoperable: TAVR|Edwards SAPIEN Transcatheter Heart Valve
1113717|NCT00530894|O2|Outcome|High Risk: SAVR|Surgical Aortic Valve Replacement
1113718|NCT00530894|O1|Outcome|High Risk: TAVR|Edwards SAPIEN Transcatheter Heart Valve
1113719|NCT00530894|O4|Outcome|Inoperable: Medical Therapy|Medical management and/or balloon aortic valvuloplasty
1113720|NCT00530894|O3|Outcome|Inoperable: TAVR|Edwards SAPIEN Transcatheter Heart Valve
1113721|NCT00530894|O2|Outcome|High Risk: SAVR|Surgical Aortic Valve Replacement
1113722|NCT00530894|O1|Outcome|High Risk: TAVR|Edwards SAPIEN Transcatheter Heart Valve
1113723|NCT00530894|O4|Outcome|Inoperable: Medical Therapy|Medical management and/or balloon aortic valvuloplasty
1113724|NCT00530894|O3|Outcome|Inoperable: TAVR|Edwards SAPIEN Transcatheter Heart Valve
1113725|NCT00530894|O2|Outcome|High Risk: SAVR|Surgical Aortic Valve Replacement
1113726|NCT00530894|O1|Outcome|High Risk: TAVR|Edwards SAPIEN Transcatheter Heart Valve
1113727|NCT00530894|O2|Outcome|Inoperable: Medical Therapy|Medical management and/or balloon aortic valvuloplasty
1113728|NCT00530894|O1|Outcome|Inoperable: TAVR|Edwards SAPIEN Transcatheter Heart Valve
1113729|NCT00530894|O4|Outcome|Inoperable: Medical Therapy|Medical management and/or balloon aortic valvuloplasty
1113730|NCT00530894|O3|Outcome|Inoperable: TAVR|Edwards SAPIEN Transcatheter Heart Valve
1113731|NCT00530894|O2|Outcome|High Risk: SAVR|Surgical Aortic Valve Replacement
1113732|NCT00530894|O1|Outcome|High Risk: TAVR|Edwards SAPIEN Transcatheter Heart Valve
1113733|NCT00530894|E4|Reported Event|Inoperable: Medical Therapy|Medical management and/or balloon aortic valvuloplasty
1113734|NCT00530894|E3|Reported Event|Inoperable: TAVR|Edwards SAPIEN Transcatheter Heart Valve
1113735|NCT00530894|E2|Reported Event|High Risk: SAVR|Surgical Aortic Valve Replacement
1113736|NCT00530894|E1|Reported Event|High Risk: TAVR|Edwards SAPIEN Transcatheter Heart Valve
1113737|NCT00530855|B1|Baseline|Lacosamide|Lacosamide tablets for dosing 100 -800 mg/day
1113738|NCT00530855|P1|Participant Flow|Lacosamide|Lacosamide tablets for dosing 100 -800 mg/day
1113739|NCT00530855|O1|Outcome|Lacosamide|Lacosamide tablets for dosing 100 -800 mg/day
1113740|NCT00530855|O1|Outcome|Lacosamide|Lacosamide tablets for dosing 100 -800 mg/day
1113741|NCT00530855|O1|Outcome|Lacosamide|Lacosamide tablets for dosing 100 -800 mg/day
1113742|NCT00530855|O1|Outcome|Lacosamide|Lacosamide tablets for dosing 100 -800 mg/day
1113743|NCT00530855|E1|Reported Event|Lacosamide|Lacosamide tablets for dosing 100 -800 mg/day
1113744|NCT00530842|B3|Baseline|Total|Total of all reporting groups
1113745|NCT00530842|B2|Baseline|Fluticasone + Salmeterol / Tiotropium + Salmeterol|Flu+Sal 500+50mcg b.i.d. / Tio 18mcg o.d. + Sal 50mcg b.i.d.
1126359|NCT00497874|O2|Outcome|Usual Care|Usual primary care treatment
1113746|NCT00530842|B1|Baseline|Tiotropium + Salmeterol / Fluticasone + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. / Flu+Sal 500+50mcg b.i.d.
1113747|NCT00530842|P2|Participant Flow|Fluticasone + Salmeterol / Tiotropium + Salmeterol|Flu+Sal 500+50mcg b.i.d. / Tio 18mcg o.d. + Sal 50mcg b.i.d.
1113748|NCT00530842|P1|Participant Flow|Tiotropium + Salmeterol / Fluticasone + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. / Flu+Sal 500+50mcg b.i.d.
1113749|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113750|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113751|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113752|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113753|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113754|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113755|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113756|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113757|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113758|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113759|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113760|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113761|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113762|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113767|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113768|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113769|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113770|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113771|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113772|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113773|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113774|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113775|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113776|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113777|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113778|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113779|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113780|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113781|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113782|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113783|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113784|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113785|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113786|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113787|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113788|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113789|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113790|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113791|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113792|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113793|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113794|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113795|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113796|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113797|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113798|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113799|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113800|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113801|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113802|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113803|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113804|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113805|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113806|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113807|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113815|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113816|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113817|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113818|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113819|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113820|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113821|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113822|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113823|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113824|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113825|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113826|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113827|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113828|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113829|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113830|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113831|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113832|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113833|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113834|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113835|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113836|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1116928|NCT00524264|P1|Participant Flow|Ketorolac Solution|
1113837|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113838|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113839|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113840|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113841|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113842|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113843|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113844|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113845|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113846|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113847|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113848|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113849|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113850|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113851|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113852|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113853|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113854|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113855|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113856|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113857|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113858|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113859|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113860|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113861|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113862|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113863|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113864|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113865|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
1113866|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
1113867|NCT00530842|E4|Reported Event|Fluticasone + Salmeterol (Period 2)|Flu+Sal 500+50mcg b.i.d. in Period 2
1113868|NCT00530842|E3|Reported Event|Fluticasone + Salmeterol (Period 1)|Flu+Sal 500+50mcg b.i.d. in Period 1
1113869|NCT00530842|E2|Reported Event|Tiotropium + Salmeterol (Period 2)|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 2
1113870|NCT00530842|E1|Reported Event|Tiotropium + Salmeterol (Period 1)|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1
1113871|NCT00530816|B4|Baseline|Total|Total of all reporting groups
1113872|NCT00530816|B3|Baseline|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of subsequent cycles, for up to 12 cycles.
1113873|NCT00530816|B2|Baseline|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
1113993|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
1113874|NCT00530816|B1|Baseline|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
1113875|NCT00530816|P3|Participant Flow|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of subsequent cycles, for up to 12 cycles.
1113876|NCT00530816|P2|Participant Flow|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
1113877|NCT00530816|P1|Participant Flow|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
1113878|NCT00530816|O3|Outcome|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
1113879|NCT00530816|O2|Outcome|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
1113880|NCT00530816|O1|Outcome|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
1113881|NCT00530816|O3|Outcome|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
1113882|NCT00530816|O2|Outcome|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
1113883|NCT00530816|O1|Outcome|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
1113884|NCT00530816|O3|Outcome|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
1113885|NCT00530816|O2|Outcome|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
1113886|NCT00530816|O1|Outcome|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
1113887|NCT00530816|O3|Outcome|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
1113888|NCT00530816|O2|Outcome|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
1113889|NCT00530816|O1|Outcome|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
1113890|NCT00530816|O3|Outcome|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
1113891|NCT00530816|O2|Outcome|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
1113892|NCT00530816|O1|Outcome|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
1113893|NCT00530816|O3|Outcome|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
1113894|NCT00530816|O2|Outcome|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
1113895|NCT00530816|O1|Outcome|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
1113896|NCT00530816|O3|Outcome|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
1113897|NCT00530816|O2|Outcome|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
1113898|NCT00530816|O1|Outcome|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
1113899|NCT00530816|E3|Reported Event|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
1113900|NCT00530816|E2|Reported Event|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
1113901|NCT00530816|E1|Reported Event|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
1113902|NCT00530790|B1|Baseline|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
1113903|NCT00530790|P1|Participant Flow|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
1113904|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
1113905|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
1113906|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
1114503|NCT00529451|E4|Reported Event|Ramipril 5 mg|Ramipril 5 mg once daily
1113907|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
1113908|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
1113909|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
1113910|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
1113911|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
1113912|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
1113913|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
1113914|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
1113915|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
1113916|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
1113917|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
1113918|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
1113919|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
1113920|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
1113921|NCT00530790|E1|Reported Event|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
1113922|NCT00530777|B3|Baseline|Total|Total of all reporting groups
1113923|NCT00530777|B2|Baseline|Placebo|oral placebo twice daily from 34 weeks gestation to 1 year postpartum
1113924|NCT00530777|B1|Baseline|Valacyclovir|500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
1113925|NCT00530777|P2|Participant Flow|Placebo|oral placebo twice daily from 34 weeks gestation to 1 year postpartum
1113926|NCT00530777|P1|Participant Flow|Valacyclovir|500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
1113927|NCT00530777|O2|Outcome|Placebo|oral placebo twice daily from 34 weeks gestation to 1 year postpartum
1113928|NCT00530777|O1|Outcome|Valacyclovir|500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
1113929|NCT00530777|O2|Outcome|Placebo|oral placebo twice daily from 34 weeks gestation to 1 year postpartum
1113930|NCT00530777|O1|Outcome|Valacyclovir|500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
1113931|NCT00530777|E2|Reported Event|Placebo|oral placebo twice daily from 34 weeks gestation to 1 year postpartum
1113932|NCT00530777|E1|Reported Event|Valacyclovir|500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
1113933|NCT00530764|B5|Baseline|Total|Total of all reporting groups
1113934|NCT00530764|B4|Baseline|Placebo|Range of 1-16 sprays per day of placebo spray
1113935|NCT00530764|B3|Baseline|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
1113936|NCT00530764|B2|Baseline|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
1113937|NCT00530764|B1|Baseline|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
1113938|NCT00530764|P4|Participant Flow|Placebo|Range of 1-16 sprays per day of placebo spray
1113939|NCT00530764|P3|Participant Flow|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
1113940|NCT00530764|P2|Participant Flow|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
1113941|NCT00530764|P1|Participant Flow|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
1113942|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
1113943|NCT00530764|O3|Outcome|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
1113944|NCT00530764|O2|Outcome|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
1113945|NCT00530764|O1|Outcome|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
1113946|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
1113947|NCT00530764|O3|Outcome|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
1113948|NCT00530764|O2|Outcome|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
1113949|NCT00530764|O1|Outcome|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
1113950|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
1113951|NCT00530764|O3|Outcome|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
1113952|NCT00530764|O2|Outcome|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
1113953|NCT00530764|O1|Outcome|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
1113954|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
1113955|NCT00530764|O3|Outcome|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
1113956|NCT00530764|O2|Outcome|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
1113957|NCT00530764|O1|Outcome|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
1113958|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
1113959|NCT00530764|O3|Outcome|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
1113960|NCT00530764|O2|Outcome|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
1113961|NCT00530764|O1|Outcome|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
1113962|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
1113963|NCT00530764|O3|Outcome|Sativex Low Dose|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
1113964|NCT00530764|O2|Outcome|Sativex Medium Dose|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
1113965|NCT00530764|O1|Outcome|Sativex High Dose|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
1113966|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
1113967|NCT00530764|O3|Outcome|Sativex Low Dose|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
1114504|NCT00529451|E3|Reported Event|Aliskiren 75 mg|Aliskiren 75 mg once daily
1113968|NCT00530764|O2|Outcome|Sativex Medium Dose|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
1113969|NCT00530764|O1|Outcome|Sativex High Dose|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
1113970|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
1113971|NCT00530764|O3|Outcome|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
1113972|NCT00530764|O2|Outcome|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
1113973|NCT00530764|O1|Outcome|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
1113974|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
1113975|NCT00530764|O3|Outcome|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
1113976|NCT00530764|O2|Outcome|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
1113977|NCT00530764|O1|Outcome|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
1113978|NCT00530764|E4|Reported Event|Placebo|Range of 1-16 sprays per day of placebo spray
1113979|NCT00530764|E3|Reported Event|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
1113980|NCT00530764|E2|Reported Event|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
1113981|NCT00530764|E1|Reported Event|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
1113982|NCT00530712|B1|Baseline|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex™ Peripheral Self-Expanding Stent System
1113983|NCT00530712|P1|Participant Flow|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex™ Peripheral Self-Expanding Stent System
1113984|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
1113985|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
1113986|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
1113987|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
1113988|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
1113989|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
1113990|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
1113991|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
1113992|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
1114113|NCT00530023|P1|Participant Flow|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
1113994|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex™ Peripheral Self-Expanding Stent System
1113995|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
1113996|NCT00530712|E1|Reported Event|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
1113997|NCT00530634|B1|Baseline|Gemcitabine + Cisplatin|Surgical resection followed by (within 60 days) by chemotherapy (Gemcitabine at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle and Cisplatin at 75 mg/m2 IV over 1 hour on day 8 of a 21 day cycle) followed by radiation therapy (treated using linear accelerator with photon beam energy of 6-21 MV) upon completion of 3 cycles of chemotherapy.
1113998|NCT00530634|P1|Participant Flow|Gemcitabine + Cisplatin|Surgical resection followed by (within 60 days) by chemotherapy (Gemcitabine at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle and Cisplatin at 75 mg/m2 IV over 1 hour on day 8 of a 21 day cycle) followed by radiation therapy (treated using linear accelerator with photon beam energy of 6-21 MV) upon completion of 3 cycles of chemotherapy.
1113999|NCT00530634|O1|Outcome|Gemcitabine + Cisplatin|Surgical resection followed by (within 60 days) by chemotherapy (Gemcitabine at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle and Cisplatin at 75 mg/m2 IV over 1 hour on day 8 of a 21 day cycle) followed by radiation therapy (treated using linear accelerator with photon beam energy of 6-21 MV) upon completion of 3 cycles of chemotherapy.
1114000|NCT00530634|E1|Reported Event|Gemcitabine + Cisplatin|Surgical resection followed by (within 60 days) by chemotherapy (Gemcitabine at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle and Cisplatin at 75 mg/m2 IV over 1 hour on day 8 of a 21 day cycle) followed by radiation therapy (treated using linear accelerator with photon beam energy of 6-21 MV) upon completion of 3 cycles of chemotherapy.
1114001|NCT00530504|B1|Baseline|Intervention|PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.
1114002|NCT00530504|P1|Participant Flow|Intervention|PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.
1114003|NCT00530504|O1|Outcome|Intervention|PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.
1114004|NCT00530504|E1|Reported Event|Intervention|PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.
1114005|NCT00530439|B3|Baseline|Total|Total of all reporting groups
1114006|NCT00530439|B2|Baseline|Control|
1114007|NCT00530439|B1|Baseline|Lifestyle Intervention|physical activity, dietetic counselling
1114008|NCT00530439|P2|Participant Flow|Control|
1114009|NCT00530439|P1|Participant Flow|Lifestyle Intervention|physical activity, dietetic counselling
1114010|NCT00530439|O2|Outcome|Control|
1114011|NCT00530439|O1|Outcome|Lifestyle Intervention|physical activity, dietetic counselling
1114012|NCT00530439|E2|Reported Event|Control|
1114013|NCT00530439|E1|Reported Event|Lifestyle Intervention|physical activity, dietetic counselling
1114014|NCT00530348|B3|Baseline|Total|Total of all reporting groups
1114015|NCT00530348|B2|Baseline|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
1114016|NCT00530348|B1|Baseline|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
1114017|NCT00530348|P2|Participant Flow|Alemtuzumab|Alemtuzumab (Lemtrada™) 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
1114018|NCT00530348|P1|Participant Flow|Interferon Beta-1a|Interferon beta-1a (Rebif®) 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
1114019|NCT00530348|O2|Outcome|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
1114020|NCT00530348|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
1114021|NCT00530348|O2|Outcome|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
1114022|NCT00530348|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
1114023|NCT00530348|O2|Outcome|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
1114024|NCT00530348|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
1114025|NCT00530348|O2|Outcome|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
1114026|NCT00530348|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
1114027|NCT00530348|O2|Outcome|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
1114028|NCT00530348|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
1114029|NCT00530348|O2|Outcome|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
1114030|NCT00530348|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
1114031|NCT00530348|E2|Reported Event|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
1114032|NCT00530348|E1|Reported Event|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
1114033|NCT00530335|B1|Baseline|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
1114034|NCT00530335|P1|Participant Flow|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
1114035|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
1114036|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
1114037|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
1114038|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
1114039|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
1114040|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
1114041|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
1114069|NCT00530257|O2|Outcome|Placebo|This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
1114042|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
1114043|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
1114044|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
1114045|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
1114046|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
1114047|NCT00530335|E1|Reported Event|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
1114048|NCT00530270|B3|Baseline|Total|Total of all reporting groups
1114049|NCT00530270|B2|Baseline|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
1114050|NCT00530270|B1|Baseline|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
1114051|NCT00530270|P2|Participant Flow|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
1114052|NCT00530270|P1|Participant Flow|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
1114053|NCT00530270|O2|Outcome|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
1114054|NCT00530270|O1|Outcome|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
1114055|NCT00530270|O2|Outcome|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
1114056|NCT00530270|O1|Outcome|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
1114057|NCT00530270|O2|Outcome|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
1114058|NCT00530270|O1|Outcome|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
1114059|NCT00530270|O2|Outcome|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
1114060|NCT00530270|O1|Outcome|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
1114061|NCT00530270|O2|Outcome|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
1114062|NCT00530270|O1|Outcome|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
1114918|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy
1114063|NCT00530270|E2|Reported Event|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
1114064|NCT00530270|E1|Reported Event|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
1114065|NCT00530257|B1|Baseline|OROS Methylphenidate|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child’s performance on different domains of attention and executive functioning was assessed on the measures described below.
1114066|NCT00530257|P1|Participant Flow|OROS Methylphenidate|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child’s performance on different domains of attention and executive functioning was assessed on the measures described below.
1114067|NCT00530257|O2|Outcome|Placebo|This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
1114068|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
1114070|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
1114071|NCT00530257|O2|Outcome|Placebo|This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
1114072|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
1114073|NCT00530257|O2|Outcome|Placebo|This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
1114074|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
1114075|NCT00530257|O2|Outcome|Placebo|This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
1114076|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
1114077|NCT00530257|O2|Outcome|Placebo|This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
1114078|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
1114079|NCT00530257|O2|Outcome|Placebo|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
1114080|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
1114081|NCT00530257|O2|Outcome|Placebo|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
1114082|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
1114083|NCT00530257|O2|Outcome|Placebo|This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
1127293|NCT00494221|O1|Outcome|Cediranib 20 mg|FOLFOX + Cediranib 20 mg
1114084|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child’s performance on different domains of attention and executive functioning was assessed.
1114085|NCT00530257|O2|Outcome|Placebo|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
1114086|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
1114087|NCT00530257|O2|Outcome|Placebo|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
1114088|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
1114089|NCT00530257|O2|Outcome|Placebo|This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
1114090|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
1114091|NCT00530257|E2|Reported Event|Placebo|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the parents rated medication side effects on the Stimulant Side Effect Rating Scale (described previously). Score of 7-9 on this scale were considered adverse effects.
1114092|NCT00530257|E1|Reported Event|OROS Methylphenidate|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the parents rated medication side effects on the Stimulant Side Effect Rating Scale (described previously). Score of 7-9 on this scale were considered adverse effects.
1114093|NCT00530088|B1|Baseline|Porfimer Sodium|"Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber.~porfimer sodium: IV"
1114094|NCT00530088|P1|Participant Flow|Porfimer Sodium|"Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber.~porfimer sodium: IV"
1114095|NCT00530088|O1|Outcome|Porfimer Sodium|"Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber.~porfimer sodium: IV"
1114096|NCT00530088|O1|Outcome|Porfimer Sodium|"Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber.~porfimer sodium: IV"
1114097|NCT00530088|E1|Reported Event|Porfimer Sodium|"Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber.~porfimer sodium: IV"
1114098|NCT00530075|B1|Baseline|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
1114099|NCT00530075|P1|Participant Flow|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
1114100|NCT00530075|O1|Outcome|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
1114101|NCT00530075|O1|Outcome|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
1114102|NCT00530075|O1|Outcome|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
1114103|NCT00530075|O1|Outcome|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
1114104|NCT00530075|O1|Outcome|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
1114105|NCT00530075|O1|Outcome|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
1114106|NCT00530075|O1|Outcome|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
1114107|NCT00530075|O1|Outcome|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
1114108|NCT00530075|E1|Reported Event|Gusperimus|SC, 0.5mg/kg/day, consecutive 21 days administration, 7 days rest, 6 cycles
1114109|NCT00530023|B3|Baseline|Total|Total of all reporting groups
1114110|NCT00530023|B2|Baseline|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
1114111|NCT00530023|B1|Baseline|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
1114112|NCT00530023|P2|Participant Flow|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
1114114|NCT00530023|O2|Outcome|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
1114115|NCT00530023|O1|Outcome|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
1114116|NCT00530023|O2|Outcome|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
1114117|NCT00530023|O1|Outcome|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
1114118|NCT00530023|O2|Outcome|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
1114119|NCT00530023|O1|Outcome|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
1114120|NCT00530023|O2|Outcome|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
1114121|NCT00530023|O1|Outcome|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
1114122|NCT00530023|O2|Outcome|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
1114123|NCT00530023|O1|Outcome|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
1114124|NCT00530023|E2|Reported Event|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
1114125|NCT00530023|E1|Reported Event|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
1114126|NCT00529789|B1|Baseline|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
1114127|NCT00529789|P1|Participant Flow|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
1114206|NCT00529659|E2|Reported Event|Placebo|Placebo administered orally twice daily.
1114207|NCT00529659|E1|Reported Event|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
1114128|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
1114129|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
1114130|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
1114131|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
1114132|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
1114133|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
1114134|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
1114135|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
1114136|NCT00529789|O5|Outcome|Duloxetine - 120 mg|120 milligrams (mg) every day, once-daily (QD), by mouth (PO); If patient is ≤40kg, initial dose is 20mg, then titrated up. If patient is >40kg, initial dose is 30mg, then titrated up.
1114137|NCT00529789|O4|Outcome|Duloxetine Dose - 90 mg|90 milligrams (mg) every day (QD), by mouth (PO); If patient is ≤40kg, initial dose is 20mg, then titrated up. If patient is >40kg, initial dose is 30mg, then titrated up.
1114138|NCT00529789|O3|Outcome|Duloxetine - 60 mg|60 milligrams (mg) every day, once-daily (QD), by mouth (PO); If patient is ≤40kg, initial dose is 20mg, then titrated up. If patient is >40kg, initial dose is 30mg, then titrated up.
1114139|NCT00529789|O2|Outcome|Duloxetine Dose - 30 mg|30 milligrams (mg) every day, once-daily (QD), by mouth (PO); If patient is ≤40kg, initial dose is 20mg, then titrated up. If patient is >40kg, initial dose is 30mg, then titrated up.
1114140|NCT00529789|O1|Outcome|Duloxetine Dose - 20 mg|20 milligrams (mg) every day, once-daily (QD), by mouth (PO); If patient is ≤40kg, initial dose is 20mg, then titrated up.
1114141|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
1114142|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
1114143|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
1114144|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
1114145|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
1114146|NCT00529789|E2|Reported Event|Duloxetine - Period IV|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) between Weeks 18 - 30; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
1114147|NCT00529789|E1|Reported Event|Duloxetine - Period II/III|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 18 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
1114148|NCT00529763|B4|Baseline|Total|Total of all reporting groups
1114149|NCT00529763|B3|Baseline|Chronic Phase (CP) CML|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
1114150|NCT00529763|B2|Baseline|Advanced Disease CML - Blast Phase/PH+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
1114151|NCT00529763|B1|Baseline|Advanced Disease CML - Accelerated Phase (AP)|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
1114152|NCT00529763|P3|Participant Flow|Chronic Phase (CP) CML|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
1114208|NCT00529633|B3|Baseline|Total|Total of all reporting groups
1114505|NCT00529451|E2|Reported Event|Aliskiren 150 mg|Aliskiren 150 mg once daily
1114506|NCT00529451|E1|Reported Event|Aliskiren 300 mg|Aliskiren 300 mg once daily
1114153|NCT00529763|P2|Participant Flow|Advanced Disease CML - Blast Phase/PH+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
1114154|NCT00529763|P1|Participant Flow|Advanced Disease CML - Accelerated Phase (AP)|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
1114155|NCT00529763|O2|Outcome|100 mg QD|Participants with CP CML treated with dasatinib 100 mg QD
1114156|NCT00529763|O1|Outcome|70 mg BID|Participants with AP CML or Ph+ ALL treated with 70 mg dasatinib BID
1114157|NCT00529763|O2|Outcome|100 mg QD|Participants with CP CML treated with dasatinib 100 mg QD
1114158|NCT00529763|O1|Outcome|70 mg BID|Participants with AP CML or Ph+ ALL treated with 70 mg dasatinib BID
1114159|NCT00529763|O2|Outcome|100 mg QD|Participants with CP CML treated with dasatinib 100 mg QD
1114160|NCT00529763|O1|Outcome|70 mg BID|Participants with AP CML or Ph+ ALL treated with 70 mg dasatinib BID
1114161|NCT00529763|O2|Outcome|100 mg QD|Participants with CP CML treated with dasatinib 100 mg QD
1114162|NCT00529763|O1|Outcome|70 mg BID|Participants with AP CML or Ph+ ALL treated with 70 mg dasatinib BID
1114163|NCT00529763|O2|Outcome|100 mg QD|Participants with CP CML treated with dasatinib 100 mg QD
1114164|NCT00529763|O1|Outcome|70 mg BID|Participants with AP CML or Ph+ ALL treated with 70 mg dasatinib BID
1114165|NCT00529763|O2|Outcome|100 mg QD|Participants with CP CML treated with dasatinib 100 mg QD
1114166|NCT00529763|O1|Outcome|70 mg BID|Participants with AP CML or Ph+ ALL treated with 70 mg dasatinib BID
1114167|NCT00529763|O3|Outcome|Blast Phase CML/Ph+ ALL|Participants with MyBP or LyBP CML or Ph+ALL who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID in advanced phase CML or Ph+ ALL. Participants with advanced disease with BID dosing were required to take their dose in the morning and evening. Subjects will be treated until progression of disease or intolerable toxicity as determined by the treating physician.
1114168|NCT00529763|O2|Outcome|Accelerated CML|Participants with Ph+ AP who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance.Dasatinib was administered orally at a dose of 70 mg BID in advanced phase CML or Ph+ ALL. Participants with advanced disease with BID dosing were required to take their dose in the morning and evening. Subjects will be treated until progression of disease or intolerable toxicity as determined by the treating physician.
1114169|NCT00529763|O1|Outcome|Chronic Phase (CP) CML|Participants with Ph+ CP CML who have received prior treatment with Imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants with chronic phase CML with QD dosing were permitted to take their dose either in the morning or evening. Subjects will be treated until progression of disease or intolerable toxicity as determined by the treating physician.
1114170|NCT00529763|O2|Outcome|Advanced Disease CML - Blast Phase/PH+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
1114171|NCT00529763|O1|Outcome|Advanced Disease CML - Accelerated Phase (AP)|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
1114172|NCT00529763|O2|Outcome|Advanced Disease CML - Blast Phase/PH+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
1127294|NCT00494221|O3|Outcome|Placebo|FOLFOX + Placebo
1114173|NCT00529763|O1|Outcome|Advanced Disease CML - Accelerated Phase (AP)|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
1114174|NCT00529763|O2|Outcome|Advanced Disease CML - Blast Phase/PH+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
1114175|NCT00529763|O1|Outcome|Advanced Disease CML - Accelerated Phase (AP)|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
1114176|NCT00529763|O3|Outcome|Total|All treated Participants with Advanced Disease CML - Accelerated Phase (AP) and Blast Phase/PH+ ALL
1114209|NCT00529633|B2|Baseline|Placebo|"12 End stage renal disease (ESRD) patients on hemodialysis for at least 3 months~Serum C reactive protein level of ≥ 0.8 mg/dl~Serum albumin < 3.8 g/dl (BCG)~Patients will receive Placebo for a period of 24 weeks."
1114177|NCT00529763|O2|Outcome|Advanced Disease CML - Blast Phase/PH+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
1114178|NCT00529763|O1|Outcome|Advanced Disease CML - Accelerated Phase (AP)|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
1114179|NCT00529763|O1|Outcome|CP CML|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
1114180|NCT00529763|O1|Outcome|Chronic Phase (CP) CML|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
1114181|NCT00529763|O1|Outcome|Chronic Phase (CP) CML|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
1114182|NCT00529763|O1|Outcome|Chronic Phase (CP) CML|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
1114183|NCT00529763|O2|Outcome|Advanced Disease CML - Blast Phase/PH+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
1114184|NCT00529763|O1|Outcome|Advanced Disease CML - Accelerated Phase (AP)|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
1114185|NCT00529763|O1|Outcome|Chronic Phase (CP) CML|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
1114186|NCT00529763|E3|Reported Event|Chronic Phase|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
1114187|NCT00529763|E2|Reported Event|Blast Phase / Ph+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
1114188|NCT00529763|E1|Reported Event|Accelerated Phase|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
1114189|NCT00529659|B3|Baseline|Total|Total of all reporting groups
1114190|NCT00529659|B2|Baseline|Placebo|Placebo administered orally twice daily.
1114191|NCT00529659|B1|Baseline|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
1114192|NCT00529659|P2|Participant Flow|Placebo|Placebo administered orally twice daily.
1114193|NCT00529659|P1|Participant Flow|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
1114194|NCT00529659|O2|Outcome|Placebo|Placebo administered orally twice daily.
1114195|NCT00529659|O1|Outcome|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
1114196|NCT00529659|O2|Outcome|Placebo|Placebo administered orally twice daily.
1114197|NCT00529659|O1|Outcome|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
1114198|NCT00529659|O2|Outcome|Placebo|Placebo administered orally twice daily.
1114199|NCT00529659|O1|Outcome|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
1114200|NCT00529659|O2|Outcome|Placebo|Placebo administered orally twice daily.
1114201|NCT00529659|O1|Outcome|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
1114202|NCT00529659|O2|Outcome|Placebo|Placebo administered orally twice daily.
1114203|NCT00529659|O1|Outcome|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
1114204|NCT00529659|O2|Outcome|Placebo|Placebo administered orally twice daily.
1114205|NCT00529659|O1|Outcome|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
1114210|NCT00529633|B1|Baseline|Thalidomid|"12 End stage renal disease (ESRD) patients on hemodialysis for at least 3 months~Serum C reactive protein level of ≥ 0.8 mg/dl~Serum albumin < 3.8 g/dl (BCG)~Patients will receive Thalidomide for a period of 24 weeks.100 mg by mouth at night for 4 weeks; then if tolerated, Thalidomid will be increased to 200 mg by mouth at night for 20 weeks; for a total of 24 weeks on Thalidomid"
1114211|NCT00529633|P2|Participant Flow|Thalidomide|"End stage renal disease (ESRD) patients on hemodialysis for at least 3 months~Serum C reactive protein level of ≥ 0.8 mg/dl~Serum albumin < 3.8 g/dl (BCG)~Patients will receive Thalidomide for a period of 24 weeks.~Blood will be drawn every 4 weeks for a total of 28 weeks to establish the effect on albumin, prealbumin and CRP~Thalidomide : 100 mg by mouth at night for 4 weeks 200 mg by mouth at night for 20 weeks"
1114212|NCT00529633|P1|Participant Flow|Placebo|"This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with a placebo for 24 weeks.~Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin. Subject must meet capsule count of >85% compliance with regard to medication and/or birth control requirements as outlined in the S.T.E.P.S ® in the first 4 weeks of study program"
1114213|NCT00529633|O2|Outcome|Placebo|Placebo Control--This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with a placebo for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin
1114214|NCT00529633|O1|Outcome|Thalidomide|This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with Thalidomide for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin Dosage at 2x 50mg each night; if somnolence tolerated, dosage will increase to 4x50mg per night
1114215|NCT00529633|O2|Outcome|Placebo|Placebo Control--This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with a placebo for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin
1114216|NCT00529633|O1|Outcome|Thalidomide|This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with Thalidomide for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin Dosage at 2x 50mg each night; if somnolence tolerated, dosage will increase to 4x50mg per night
1114217|NCT00529633|O2|Outcome|Placebo|Placebo Control--This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with a placebo for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin
1114218|NCT00529633|O1|Outcome|Thalidomide|This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with Thalidomide for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin Dosage at 2x 50mg each night; if somnolence tolerated, dosage will increase to 4x50mg per night
1114219|NCT00529633|E2|Reported Event|Placebo|
1114220|NCT00529633|E1|Reported Event|Thalidomide|
1114221|NCT00529568|B3|Baseline|Total|Total of all reporting groups
1114222|NCT00529568|B2|Baseline|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114223|NCT00529568|B1|Baseline|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114224|NCT00529568|P3|Participant Flow|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114225|NCT00529568|P2|Participant Flow|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114279|NCT00529555|P1|Participant Flow|Scaling and Root Planing + SHAM TX|Empty syringe + Scaling and root planing
1114226|NCT00529568|P1|Participant Flow|Eltrombopag: Open-label Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <100 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during the Open-label Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
1114227|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114228|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114229|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114298|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
1114299|NCT00529542|O2|Outcome|Placebo|Placebo qd
1114230|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114231|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114232|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114233|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114234|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114235|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114236|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114237|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114238|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114239|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114240|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114241|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114242|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114280|NCT00529555|O3|Outcome|Scaling and Root Planing + Vehicle|"Placebo~Scaling and root planing : scaling and root planing"
1114282|NCT00529555|O1|Outcome|Scaling and Root Planing + SHAM TX|"sham treatment~Scaling and root planing : scaling and root planing"
1115545|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
1114243|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114244|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114245|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114246|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114247|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114248|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114249|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114250|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114251|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114252|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114253|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114254|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114255|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114256|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114257|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114258|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114259|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114260|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114281|NCT00529555|O2|Outcome|Scaling and Root Planing + Periocline Gel|"Minocycline HCL 2.1%~minocycline HCl 2.1% : Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months."
1115546|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
1114261|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114262|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114263|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114264|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114300|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
1114301|NCT00529542|O2|Outcome|Placebo|Placebo qd
1114302|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
1114303|NCT00529542|O2|Outcome|Placebo|Placebo qd
1114304|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
1114305|NCT00529542|O2|Outcome|Placebo|Placebo qd
1114265|NCT00529568|O1|Outcome|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <100 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
1114266|NCT00529568|O1|Outcome|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <100 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
1114267|NCT00529568|O1|Outcome|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <100 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
1114268|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114269|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114270|NCT00529568|E3|Reported Event|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114271|NCT00529568|E2|Reported Event|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1114272|NCT00529568|E1|Reported Event|Eltrombopag: OL Phase|Participants with a platelet count of &lt;75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was &lt;100 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained &lt;100 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts &gt;=100 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts &gt;=100 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
1114273|NCT00529555|B4|Baseline|Total|Total of all reporting groups
1114274|NCT00529555|B3|Baseline|Scaling and Root Planing + Vehicle|"Placebo~Scaling and root planing : scaling and root planing"
1114275|NCT00529555|B2|Baseline|Scaling & Root Planing + Periocline Gel|"Minocycline HCL 2.1%~minocycline HCl 2.1% : Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months."
1114276|NCT00529555|B1|Baseline|Scaling and Root Planing + SHAM TX|"sham treatment~Scaling and root planing : scaling and root planing"
1114277|NCT00529555|P3|Participant Flow|Scaling and Root Planing + Vehicle|Gel WITHOUT 2.1% Minocycline HCl + Scaling and root planing
1114278|NCT00529555|P2|Participant Flow|Scaling & Root Planing + Periocline Gel|"Gel WITH Minocycline HCL 2.1% + Scaling & root planing~minocycline HCl 2.1% : Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months."
1127295|NCT00494221|O2|Outcome|Cediranib 30 mg|FOLFOX + Cediranib 30 mg
1114283|NCT00529555|E3|Reported Event|Scaling and Root Planing + Vehicle|"Placebo~Scaling and root planing : scaling and root planing"
1114284|NCT00529555|E2|Reported Event|Scaling & Root Planing + Periocline Gel|"Minocycline HCL 2.1%~minocycline HCl 2.1% : Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months."
1114285|NCT00529555|E1|Reported Event|Scaling and Root Planing + SHAM TX|"sham treatment~Scaling and root planing : scaling and root planing"
1114286|NCT00529542|B3|Baseline|Total|Total of all reporting groups
1114287|NCT00529542|B2|Baseline|Placebo|Placebo qd
1114288|NCT00529542|B1|Baseline|Atorvastatin|Atorvastatin, 40 mg qd
1114289|NCT00529542|P2|Participant Flow|Placebo|Placebo qd
1114290|NCT00529542|P1|Participant Flow|Atorvastatin|Atorvastatin, 40 mg qd
1114291|NCT00529542|O2|Outcome|Placebo|Placebo qd
1114292|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
1114293|NCT00529542|O2|Outcome|Placebo|Placebo qd
1114294|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
1114295|NCT00529542|O2|Outcome|Placebo|Placebo qd
1114296|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
1114297|NCT00529542|O2|Outcome|Placebo|Placebo qd
1114330|NCT00529529|B3|Baseline|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114331|NCT00529529|B2|Baseline|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114332|NCT00529529|B1|Baseline|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114333|NCT00529529|P3|Participant Flow|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114334|NCT00529529|P2|Participant Flow|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114335|NCT00529529|P1|Participant Flow|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114336|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114337|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114338|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114339|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114340|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114341|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114342|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114507|NCT00529399|B4|Baseline|Total|Total of all reporting groups
1114343|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114344|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114345|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114346|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114347|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114348|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1115547|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
1114349|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114350|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114351|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114352|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114353|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114354|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114355|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114356|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114357|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114358|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114359|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114360|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114361|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1115548|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
1114362|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114363|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114364|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114365|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114366|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114367|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114368|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114369|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114370|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114371|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114372|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114373|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114374|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1115549|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
1114375|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114376|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114377|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114378|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114379|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114380|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114381|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114382|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114383|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114384|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114385|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114386|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114387|NCT00529529|E3|Reported Event|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1115550|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
1114388|NCT00529529|E2|Reported Event|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114389|NCT00529529|E1|Reported Event|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1114390|NCT00529516|B4|Baseline|Total|Total of all reporting groups
1114391|NCT00529516|B3|Baseline|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114392|NCT00529516|B2|Baseline|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114393|NCT00529516|B1|Baseline|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
1114394|NCT00529516|P3|Participant Flow|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114395|NCT00529516|P2|Participant Flow|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114396|NCT00529516|P1|Participant Flow|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
1114397|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114398|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114399|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
1114400|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114401|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114402|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
1114403|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114404|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114405|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
1114406|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114407|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114408|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
1114409|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114410|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114411|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
1114412|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114652|NCT00529087|O1|Outcome|MOA-728 PRN (Open-label)|MOA-728 12 mg as needed (PRN) during weeks 5 through 12
1114413|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114414|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
1114415|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114416|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114417|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
1114418|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114419|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114420|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
1114421|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114422|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114423|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
1114424|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114425|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114426|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
1114546|NCT00529282|O2|Outcome|Cefepime With or Without Vancomycin|2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
1114427|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114428|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114429|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
1114430|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114431|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114432|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
1114433|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114434|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114435|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
1114436|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114437|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114438|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
1114439|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114440|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114441|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
1114442|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114443|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114444|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
1114445|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114446|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114447|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
1114448|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114449|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114450|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
1114451|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114452|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114453|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
1114454|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114455|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114456|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
1114457|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114458|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114459|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
1114460|NCT00529516|E3|Reported Event|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114461|NCT00529516|E2|Reported Event|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
1114462|NCT00529516|E1|Reported Event|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
1114463|NCT00529464|B4|Baseline|Total|Total of all reporting groups
1114464|NCT00529464|B3|Baseline|Colposcopy + LEEP|Colposcopy - a direct magnified inspection of cervix + loop electrosurgical excision procedure (LEEP) - thin, low-voltage electrified wire loop to cuts out cervix abnormal tissue.
1114465|NCT00529464|B2|Baseline|Colposcopy + Fluorescence Spectroscopy|Colposcopy - a direct magnified inspection of cervix + Fluorescence Spectroscopy - electromagnetic spectroscopy which analyzes fluorescence from a sample.
1114466|NCT00529464|B1|Baseline|Colposcopy|Colposcopy - a direct magnified inspection of cervix.
1114467|NCT00529464|P3|Participant Flow|Colposcopy + LEEP|Colposcopy - a direct magnified inspection of cervix + loop electrosurgical excision procedure (LEEP) - thin, low-voltage electrified wire loop to cuts out cervix abnormal tissue.
1114653|NCT00529087|O1|Outcome|MOA-728 PRN (Open-label)|MOA-728 12 mg as needed (PRN) during weeks 5 through 12
1114654|NCT00529087|O3|Outcome|Placebo|Once daily
1114468|NCT00529464|P2|Participant Flow|Colposcopy + Fluorescence Spectroscopy|Colposcopy - a direct magnified inspection of cervix + Fluorescence Spectroscopy - electromagnetic spectroscopy which analyzes fluorescence from a sample.
1114469|NCT00529464|P1|Participant Flow|Colposcopy|Colposcopy - a direct magnified inspection of cervix.
1114470|NCT00529464|O3|Outcome|Colposcopy + LEEP|Colposcopy - a direct magnified inspection of cervix + loop electrosurgical excision procedure (LEEP) - thin, low-voltage electrified wire loop to cuts out cervix abnormal tissue.
1114471|NCT00529464|O2|Outcome|Colposcopy + Fluorescence Spectroscopy|Colposcopy - a direct magnified inspection of cervix + Fluorescence Spectroscopy - electromagnetic spectroscopy which analyzes fluorescence from a sample.
1114472|NCT00529464|O1|Outcome|Colposcopy|Colposcopy - a direct magnified inspection of cervix.
1114473|NCT00529464|E3|Reported Event|Colposcopy + LEEP|Colposcopy - a direct magnified inspection of cervix + loop electrosurgical excision procedure (LEEP) - thin, low-voltage electrified wire loop to cuts out cervix abnormal tissue.
1114474|NCT00529464|E2|Reported Event|Colposcopy + Fluorescence Spectroscopy|Colposcopy - a direct magnified inspection of cervix + Fluorescence Spectroscopy - electromagnetic spectroscopy which analyzes fluorescence from a sample.
1114475|NCT00529464|E1|Reported Event|Colposcopy|Colposcopy - a direct magnified inspection of cervix.
1114476|NCT00529451|B5|Baseline|Total|Total of all reporting groups
1114477|NCT00529451|B4|Baseline|Ramipril 5 mg|Ramipril 5 mg once daily
1114478|NCT00529451|B3|Baseline|Aliskiren 75 mg|Aliskiren 75 mg once daily
1114479|NCT00529451|B2|Baseline|Aliskiren 150 mg|Aliskiren 150 mg once daily
1114480|NCT00529451|B1|Baseline|Aliskiren 300 mg|Aliskiren 300 mg once daily
1114481|NCT00529451|P4|Participant Flow|Ramipril 5 mg|Ramipril 5 mg once daily
1114482|NCT00529451|P3|Participant Flow|Aliskiren 75 mg|Aliskiren 75 mg once daily
1114483|NCT00529451|P2|Participant Flow|Aliskiren 150 mg|Aliskiren 150 mg once daily
1114484|NCT00529451|P1|Participant Flow|Aliskiren 300 mg|Aliskiren 300 mg once daily
1114485|NCT00529451|O2|Outcome|Ramipril 5 mg|Ramipril 5 mg once daily
1114486|NCT00529451|O1|Outcome|Aliskiren 75 mg|Aliskiren 75 mg once daily
1114487|NCT00529451|O2|Outcome|Ramipril 5 mg|Ramipril 5 mg once daily
1114488|NCT00529451|O1|Outcome|Aliskiren 150 mg|Aliskiren 150 mg once daily
1114489|NCT00529451|O2|Outcome|Ramipril 5 mg|Ramipril 5 mg once daily
1114490|NCT00529451|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg once daily
1114491|NCT00529451|O4|Outcome|Ramipril 5 mg|Ramipril 5 mg once daily
1114492|NCT00529451|O3|Outcome|Aliskiren 75 mg|Aliskiren 75 mg once daily
1114493|NCT00529451|O2|Outcome|Aliskiren 150 mg|Aliskiren 150 mg once daily
1114494|NCT00529451|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg once daily
1114495|NCT00529451|O4|Outcome|Ramipril 5 mg|Ramipril 5 mg once daily
1114496|NCT00529451|O3|Outcome|Aliskiren 75 mg|Aliskiren 75 mg once daily
1114497|NCT00529451|O2|Outcome|Aliskiren 150 mg|Aliskiren 150 mg once daily
1114498|NCT00529451|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg once daily
1114499|NCT00529451|O4|Outcome|Ramipril 5 mg|Ramipril 5 mg once daily
1114508|NCT00529399|B3|Baseline|Alum Alone|"3 injections of Aluminum hydroxide alone~Aluminum hydroxide: Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
1114509|NCT00529399|B2|Baseline|GAD-alum Plus Alum|"2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone~GAD-Alum: Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection."
1114510|NCT00529399|B1|Baseline|GAD-alum|"3 injections of GAD-Alum vaccine~GAD-Alum: Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
1114511|NCT00529399|P3|Participant Flow|Alum Alone|"3 injections of Aluminum hydroxide alone~Aluminum hydroxide: Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
1114512|NCT00529399|P2|Participant Flow|GAD-alum Plus Alum|"2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone~GAD-Alum: Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection."
1114513|NCT00529399|P1|Participant Flow|GAD-alum|"3 injections of Glutamic Acid Decarboxylase (GAD)-Alum vaccine~GAD-Alum: Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
1114514|NCT00529399|O3|Outcome|Alum Alone|"3 injections of Aluminum hydroxide alone~Aluminum hydroxide: Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
1114515|NCT00529399|O2|Outcome|GAD-alum Plus Alum|"2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone~GAD-Alum: Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection."
1114516|NCT00529399|O1|Outcome|GAD-alum|"3 injections of GAD-Alum vaccine~GAD-Alum: Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
1114517|NCT00529399|E3|Reported Event|Alum Alone|"3 injections of Aluminum hydroxide alone~Aluminum hydroxide: Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
1114518|NCT00529399|E2|Reported Event|GAD-alum Plus Alum|"2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone~GAD-Alum: Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection."
1114519|NCT00529399|E1|Reported Event|GAD-alum|"3 injections of GAD-Alum vaccine~GAD-Alum: Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
1114520|NCT00529308|B3|Baseline|Total|Total of all reporting groups
1114521|NCT00529308|B2|Baseline|Sham|Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
1114522|NCT00529308|B1|Baseline|Active|Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
1114523|NCT00529308|P2|Participant Flow|Sham|
1114524|NCT00529308|P1|Participant Flow|Active rTMS|
1114525|NCT00529308|O2|Outcome|Sham|Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
1114526|NCT00529308|O1|Outcome|Active|Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
1114527|NCT00529308|O2|Outcome|Sham|Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
1114528|NCT00529308|O1|Outcome|Active|Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
1114529|NCT00529308|O2|Outcome|Sham|Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
1114530|NCT00529308|O1|Outcome|Active|Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
1114531|NCT00529308|O2|Outcome|Sham|Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
1114532|NCT00529308|O1|Outcome|Active|Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
1114533|NCT00529308|O2|Outcome|Sham|Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
1114534|NCT00529308|O1|Outcome|Active|Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
1114535|NCT00529308|E2|Reported Event|Sham|Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
1114536|NCT00529308|E1|Reported Event|Active|Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
1114537|NCT00529282|B3|Baseline|Total|Total of all reporting groups
1114538|NCT00529282|B2|Baseline|Cefepime With or Without Vancomycin|2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
1114539|NCT00529282|B1|Baseline|Ceftobiprole Medocaril|500 mg every 8 hours - 120-minute infusion [250 mL]
1114540|NCT00529282|P2|Participant Flow|Cefepime With or Without Vancomycin|2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
1114541|NCT00529282|P1|Participant Flow|Ceftobiprole Medocaril|500 mg every 8 hours - 120-minute infusion [250 mL]
1114542|NCT00529282|O2|Outcome|Cefepime With or Without Vancomycin|2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
1114543|NCT00529282|O1|Outcome|Ceftobiprole Medocaril|500 mg every 8 hours - 120-minute infusion [250 mL]
1114544|NCT00529282|O2|Outcome|Cefepime With or Without Vancomycin|2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
1114545|NCT00529282|O1|Outcome|Ceftobiprole Medocaril|500 mg every 8 hours - 120-minute infusion [250 mL]
1114547|NCT00529282|O1|Outcome|Ceftobiprole Medocaril|500 mg every 8 hours - 120-minute infusion [250 mL]
1114548|NCT00529282|O2|Outcome|Cefepime With or Without Vancomycin|2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
1114549|NCT00529282|O1|Outcome|Ceftobiprole Medocaril|500 mg every 8 hours - 120-minute infusion [250 mL]
1114550|NCT00529282|E2|Reported Event|Cefepime With or Without Vancomycin|2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
1114551|NCT00529282|E1|Reported Event|Ceftobiprole Medocaril|500 mg every 8 hours - 120-minute infusion [250 mL]
1114552|NCT00529243|B1|Baseline|MK-0518 (Raltegravir)|Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
1114553|NCT00529243|P1|Participant Flow|MK-0518 (Raltegravir)|Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
1114554|NCT00529243|O1|Outcome|MK-0518 (Raltegravir)|Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
1114555|NCT00529243|O1|Outcome|MK-0518 (Raltegravir)|Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
1114556|NCT00529243|E1|Reported Event|MK-0518 (Raltegravir)|Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
1114557|NCT00529217|B1|Baseline|Open-Label Active|Repetitive Transcranial Magnetic Stimulation (rTMS) : Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.
1114558|NCT00529217|P1|Participant Flow|Open-Label, rTMS, Active Coil|Repetitive Transcranial Magnetic Stimulation (rTMS) : Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.
1114559|NCT00529217|O1|Outcome|Open-Label Active|Repetitive Transcranial Magnetic Stimulation (rTMS) : Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.
1114560|NCT00529217|O1|Outcome|Open-Label, rTMS, Active Coil|Repetitive Transcranial Magnetic Stimulation (rTMS) : Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.
1114561|NCT00529217|E1|Reported Event|Open-Label Active|Repetitive Transcranial Magnetic Stimulation (rTMS) : Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.
1114562|NCT00529204|B1|Baseline|Exenatide|"exenatide 5 µg BID s.c. daily for 28 days, followed by 10 µg BID s.c. daily from day 29 to week 24~exenatide: Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24"
1114563|NCT00529204|P1|Participant Flow|Exenatide|"exenatide 5 µg BID s.c. daily for 28 days, followed by 10 µg BID s.c. daily from day 29 to week 24~exenatide: Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24"
1114564|NCT00529204|O1|Outcome|Exenatide|"exenatide 5 µg BID s.c. daily for 28 days, followed by 10 µg BID s.c. daily from day 29 to week 24~exenatide: Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24"
1114565|NCT00529204|O1|Outcome|Exenatide|"exenatide 5 µg BID s.c. daily for 28 days, followed by 10 µg BID s.c. daily from day 29 to week 24~exenatide: Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24"
1114566|NCT00529204|O1|Outcome|Exenatide|"exenatide 5 µg BID s.c. daily for 28 days, followed by 10 µg BID s.c. daily from day 29 to week 24~exenatide: Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24"
1114567|NCT00529204|E1|Reported Event|Exenatide|"exenatide 5 µg BID s.c. daily for 28 days, followed by 10 µg BID s.c. daily from day 29 to week 24~exenatide: Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24"
1114568|NCT00529191|B3|Baseline|Total|Total of all reporting groups
1114569|NCT00529191|B2|Baseline|Placebo|Placebo treatment
1114570|NCT00529191|B1|Baseline|Atorvastatin|Two out of every 3 patients will receive atorvastatin.
1114571|NCT00529191|P2|Participant Flow|Placebo|Placebo treated. Patients will receive tablets daily.There will be 12 months of treatment followed by 6 months of a washout period.
1114572|NCT00529191|P1|Participant Flow|Atorvastatin|Two out of every 3 patients will receive atorvastatin in tablet form. The subject will start on 10mg of atorvastatin daily for four weeks, and then titrate up to 20mg daily. There will be 12 months of treatment followed by 6 months of a washout period.
1114573|NCT00529191|O4|Outcome|Placebo YES Islet Cell Preservation|Placebo treated. Patients will receive tablets daily.There will be 12 months of treatment followed by 6 months of a washout period.
1114574|NCT00529191|O3|Outcome|Atorvastatin YES Islet Cell Preservation|"Two out of every three patients will receive atorvastatin.~Atorvastatin: Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months"
1114575|NCT00529191|O2|Outcome|Placebo NO Islet Cell Preservation|Placebo treated. Patients will receive tablets daily.There will be 12 months of treatment followed by 6 months of a washout period.
1114576|NCT00529191|O1|Outcome|Atorvastatin NO Islet Cell Preservation|"Two out of every three patients will receive atorvastatin.~Atorvastatin: Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months"
1114577|NCT00529191|O2|Outcome|Placebo|Placebo treated. Patients will receive tablets daily.There will be 12 months of treatment followed by 6 months of a washout period.
1114578|NCT00529191|O1|Outcome|Atorvastatin|"Two out of every three patients will receive atorvastatin.~Atorvastatin: Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months"
1114579|NCT00529191|O2|Outcome|Placebo|"Participants in placebo arm who had hypoglycemic episodes requiring treatment~Placebo treated. Patients will receive tablets daily.There will be 12 months of treatment followed by 6 months of a washout period."
1114580|NCT00529191|O1|Outcome|Atorvastatin|"Participants in Atorvastatin arm who had hypoglycemic episodes requiring treatment~Two out of every three patients will receive atorvastatin.~Atorvastatin: Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months"
1114581|NCT00529191|O2|Outcome|Placebo|"Participants in placebo arm who had hypoglycemic episodes requiring treatment~Placebo treated. Patients will receive tablets daily.There will be 12 months of treatment followed by 6 months of a washout period."
1114582|NCT00529191|O1|Outcome|Atorvastatin|"Participants in Atorvastatin arm who had hypoglycemic episodes requiring treatment~Two out of every three patients will receive atorvastatin.~Atorvastatin: Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months"
1114583|NCT00529191|O2|Outcome|Placebo|"One out of three subjects will receive a placebo.~Placebo: One out of three subjects will receive a placebo."
1114584|NCT00529191|O1|Outcome|Atorvastatin|"Two out of every three patients will receive atorvastatin.~Atorvastatin: Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months"
1114585|NCT00529191|O2|Outcome|Placebo|Placebo treated. Patients will receive tablets daily.There will be 12 months of treatment followed by 6 months of a washout period.
1114586|NCT00529191|O1|Outcome|Atorvastatin|"Two out of every three patients will receive atorvastatin.~Atorvastatin: Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months"
1114587|NCT00529191|O2|Outcome|Placebo|Placebo treatment
1114588|NCT00529191|O1|Outcome|Atorvastatin|Two out of every 3 patients will receive atorvastatin.
1114589|NCT00529191|O2|Outcome|Placebo|Placebo treatment
1114590|NCT00529191|O1|Outcome|Atorvastatin|Two out of every 3 patients will receive atorvastatin.
1114591|NCT00529191|E2|Reported Event|Placebo|Placebo treatment
1114592|NCT00529191|E1|Reported Event|Atorvastatin|Two out of every 3 patients will receive atorvastatin.
1114593|NCT00529152|B1|Baseline|Ferriprox Oral Solution|All subjects were administered Ferriprox Oral Solution three times daily for a total daily dose of either 50, 75 or 100 mg/kg/day. Subjects were initiated at a dose of 50 mg/kg/day, but this dose could be increased after two weeks of therapy depending on the subjects' individual needs.
1114594|NCT00529152|P1|Participant Flow|Ferriprox Oral Solution|All subjects were administered Ferriprox Oral Solution three times daily for a total daily dose of either 50, 75 or 100 mg/kg/day. Subjects were initiated at a dose of 50 mg/kg/day, but this dose could be increased after two weeks of therapy depending on the subjects' individual needs.
1115551|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
1114595|NCT00529152|O1|Outcome|Ferriprox Oral Solution|All subjects were administered Ferriprox Oral Solution three times daily for a total daily dose of either 50, 75 or 100 mg/kg/day. Subjects were initiated at a dose of 50 mg/kg/day, but this dose could be increased after two weeks of therapy depending on the subjects' individual needs.
1114596|NCT00529152|O1|Outcome|Ferriprox Oral Solution|All subjects were administered Ferriprox Oral Solution three times daily for a total daily dose of either 50, 75 or 100 mg/kg/day. Subjects were initiated at a dose of 50 mg/kg/day, but this dose could be increased after two weeks of therapy depending on the subjects' individual needs.
1114597|NCT00529126|B5|Baseline|Total|Total of all reporting groups
1114598|NCT00529126|B4|Baseline|Bupivacaine HCl|A single dose of 75 mg bupivacaine was to be administered intraoperatively via local infiltration
1114599|NCT00529126|B3|Baseline|SKY0402 Low Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
1114600|NCT00529126|B2|Baseline|SKY0402 Middle Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
1114601|NCT00529126|B1|Baseline|SKY0402 High Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
1114602|NCT00529126|P4|Participant Flow|Bupivacaine HCl|A single dose of 75 mg bupivacaine was to be administered intraoperatively via local infiltration
1114603|NCT00529126|P3|Participant Flow|SKY0402 Low Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
1114604|NCT00529126|P2|Participant Flow|SKY0402 Middle Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
1114605|NCT00529126|P1|Participant Flow|SKY0402 High Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
1114606|NCT00529126|O4|Outcome|Bupivacaine HCl|A single dose of 75 mg bupivacaine was to be administered intraoperatively via local infiltration
1114607|NCT00529126|O3|Outcome|SKY0402 Low Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
1114608|NCT00529126|O2|Outcome|SKY0402 Middle Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
1114609|NCT00529126|O1|Outcome|SKY0402 High Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
1114610|NCT00529126|E4|Reported Event|Bupivacaine HCl|A single dose of 75 mg bupivacaine was to be administered intraoperatively via local infiltration
1114611|NCT00529126|E3|Reported Event|SKY0402 Low Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
1114612|NCT00529126|E2|Reported Event|SKY0402 Middle Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
1114613|NCT00529126|E1|Reported Event|SKY0402 High Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
1114614|NCT00529100|B4|Baseline|Total|Total of all reporting groups
1114615|NCT00529100|B3|Baseline|Pemetrexed/Cisplatin/Radiation Phase 2|Participants were strictly in Phase 2. Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m2 IV.
1114616|NCT00529100|B2|Baseline|Pemetrexed/Cisplatin/Radiation Phase 1-Phase 2|Participants were overlap in Phase 1 and Phase 2.
1114617|NCT00529100|B1|Baseline|Pemetrexed/Cisplatin/Radiation Phase 1|Participants were strictly in Phase 1. Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m^2) IV through 500 mg/m^2 on Days 1 and 22; concurrent cisplatin 25 mg/m^2 IV on Days 1-3 and 22-24 for the first three cohorts and cisplatin 20 mg/m^2 IV on Days 1-5 and 22-26 for Cohort 4. Participants then received 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
1114618|NCT00529100|P2|Participant Flow|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
1114619|NCT00529100|P1|Participant Flow|Pemetrexed/Cisplatin/Radiation Phase 1|Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m^2) IV through 500 mg/m^2 IV on Days 1 and 22; concurrent cisplatin 25 mg/m^2 IV on Days 1-3 and 22-24 for the first three cohorts and cisplatin 20 mg/m^2 IV on Days 1-5 and 22-26 for Cohort 4. Participants then received 2 additional consolidation cycles (every 3 weeks [q3 weeks]) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
1114620|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
1114621|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
1114622|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
1114655|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
1114656|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
1114623|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
1114624|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
1114625|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if two-phase treatment and 62-66 Gy in 31-33 fractions if one-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and two additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2.
1114626|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 1|Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if two-phase treatment and 62-66 Gy in 31-33 fractions if one-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m^2) through 500 mg/m^2 on Days 1 and 22; concurrent cisplatin 25 mg/m^2 on Days 1-3 and 22-24 for the first three cohorts and cisplatin 20 mg/m^2 on Days 1-5 and 22-26 for Cohort 4. Participants then received two additional consolidation cycles (q3 weekly) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2.
1114627|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if two-phase treatment and 62-66 Gy in 31-33 fractions if one-phase treatment; concurrent pemetrexed 500 mg/m^2 as determined by phase 1 trial on Days 1 and 22; concurrent cisplatin 20 mg/m^2 as determined by phase 1 trial with cycles commencing on Days 1 and 22; two additional consolidation cycles (q3 weekly) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m2.
1114628|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 1|Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if two-phase treatment and 62-66 Gy in 31-33 fractions if one-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m^2) through 500 mg/m^2 on Days 1 and 22; concurrent cisplatin 25 mg/m^2 on Days 1-3 and 22-24 for the first three cohorts and cisplatin 20 mg/m^2 on days 1-5 and 22-26 for cohort four. Participants then received two additional consolidation cycles (q3 weekly) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2.
1114629|NCT00529100|E3|Reported Event|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if two-phase treatment and 62-66 Gy in 31-33 fractions if one-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and two additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2.
1114630|NCT00529100|E2|Reported Event|Pemetrexed/Cisplatin/Radiation Phase 1-2|"Cohort 4 data from Phase (Ph) 1 was included in the Ph 2 analysis as Cohort 4 was the established dose from Ph 1.~Ph 1: radiation as 61-65 Gray (Gy) in 33-35 fractions if 2-phase treatment/62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus with doses escalating from 300 milligrams per square meter (mg/m^2) through 500 mg/m^2 on Days 1 and 22; concurrent cisplatin 25 mg/m^2 on Days 1-3 and 22-24 for the first 3 cohorts and cisplatin 20 mg/m^2 on Days 1-5 and 22-26 for Cohort 4. Participants then received 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2.~Ph 2: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment/62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus from Ph 1 trial on Days 1 and 22; concurrent cisplatin from Ph 1 trial with cycles commencing on Days 1 and 22; and 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2."
1116929|NCT00524264|O2|Outcome|Vehicle Solution|
1114631|NCT00529100|E1|Reported Event|Pemetrexed/Cisplatin/Radiation Phase 1|Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if two-phase treatment and 62-66 Gy in 31-33 fractions if one-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m^2) through 500 mg/m^2 on Days 1 and 22; concurrent cisplatin 25 mg/m^2 on Days 1-3 and 22-24 for the first three cohorts and cisplatin 20 mg/m^2 on Days 1-5 and 22-26 for Cohort 4. Participants then received two additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2.
1114632|NCT00529087|B4|Baseline|Total|Total of all reporting groups
1114633|NCT00529087|B3|Baseline|Placebo (Double-blind)|Once daily for weeks 1 through 4
1114634|NCT00529087|B2|Baseline|MOA-728 QOD (Double-blind)|MOA-728 12 mg once every other day, Placebo once daily on alternating days for weeks 1 through 4
1114635|NCT00529087|B1|Baseline|MOA-728 QD (Double-blind)|MOA-728 12 mg once daily (QD) for weeks 1 through 4
1114636|NCT00529087|P3|Participant Flow|Placebo (Double-blind)|Once daily for weeks 1 through 4
1114637|NCT00529087|P2|Participant Flow|MOA-728 QOD (Double-blind)|MOA-728 12 mg once every other day, Placebo once daily on alternating days for weeks 1 through 4
1114638|NCT00529087|P1|Participant Flow|MOA-728 QD (Double-blind)|MOA-728 12 mg once daily (QD) for weeks 1 through 4
1114639|NCT00529087|O3|Outcome|Placebo|Once daily
1114640|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
1114641|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
1114642|NCT00529087|O3|Outcome|Placebo|Once daily
1114643|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
1114644|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
1114645|NCT00529087|O1|Outcome|MOA-728 PRN (Open-label)|MOA-728 12 mg as needed (PRN) during weeks 5 through 12
1114646|NCT00529087|O3|Outcome|Placebo|Once daily
1114647|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
1114648|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
1114649|NCT00529087|O3|Outcome|Placebo|Once daily
1114650|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
1114651|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
1114658|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
1114659|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
1114660|NCT00529087|O3|Outcome|Placebo|Once daily
1114661|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
1114662|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
1114663|NCT00529087|O3|Outcome|Placebo|Once daily
1114664|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
1114665|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
1114666|NCT00529087|O3|Outcome|Placebo|Once daily
1114667|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
1114668|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
1114669|NCT00529087|O3|Outcome|Placebo|Once daily
1114670|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
1114671|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
1114672|NCT00529087|O3|Outcome|Placebo|Once daily
1114673|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
1114674|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
1114675|NCT00529087|O3|Outcome|Placebo|Once daily
1114676|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
1114677|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
1114678|NCT00529087|O4|Outcome|Placebo QD (Only QOD Injections)|Placebo group using odd numbered injections corresponding to the active injections in the MOA-728 QOD group. The same placebo patients of 162 was used for each active drug group (QD and QOD).
1114679|NCT00529087|O3|Outcome|Placebo|Once daily
1114680|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day, Placebo once daily on alternating days
1114681|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
1114682|NCT00529087|O3|Outcome|Placebo|Once daily
1114683|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
1114684|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
1114685|NCT00529087|O1|Outcome|MOA-728 PRN (Open-label)|MOA-728 12 mg as needed (PRN) during weeks 5 through 12
1114686|NCT00529087|O3|Outcome|Placebo|Once daily
1114687|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
1114688|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
1114689|NCT00529087|O2|Outcome|Placebo|Once daily
1114690|NCT00529087|O1|Outcome|MOA-728 QD and MOA-728 QOD|MOA-728 12 mg once daily (QD) and MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
1114691|NCT00529087|O4|Outcome|Placebo QD|Once daily
1114692|NCT00529087|O3|Outcome|Placebo QD (Only QOD Injections)|Placebo group using odd numbered injections corresponding to the active injections in the MOA-728 QOD group. The same placebo patients of 162 was used for each active drug group (QD and QOD).
1114693|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), with placebo once daily on alternating days
1114694|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
1114695|NCT00529087|O2|Outcome|Placebo|Once daily
1114696|NCT00529087|O1|Outcome|MOA-728 QD and MOA-728 QOD|MOA-728 QD treatment group (12 mg every day) and MOA-728 QOD treatment group (12 mg once every other day, with placebo once daily on alternating days).
1114697|NCT00529087|E4|Reported Event|MOA-728 PRN (Open-label)|MOA-728 12 mg as needed (PRN) for weeks 5 through 12
1116930|NCT00524264|O1|Outcome|Ketorolac Solution|
1114698|NCT00529087|E3|Reported Event|Placebo (Double-blind)|Once daily for weeks 1 through 4
1114699|NCT00529087|E2|Reported Event|MOA-728 QOD (Double-blind)|MOA-728 12 mg once every other day, Placebo once daily on alternating days for weeks 1 through 4
1114700|NCT00529087|E1|Reported Event|MOA-728 QD (Double-blind)|MOA-728 12 mg once daily (QD) for weeks 1 through 4
1114701|NCT00529035|B1|Baseline|Group 1|
1114702|NCT00529035|P1|Participant Flow|Ultra-low Dose Interleukin-2|"Daily subcutaneous administration of Interleukin-2 evaluated at three dose levels:~Dose level A: 0.3 x 10^6 IU/m^2/day Dose level B: 1.0 x 10^6 IU/m^2/day Dose level C: 3.0 x 10^6 IU/M^2/day"
1114703|NCT00529035|O3|Outcome|Median Treg:Tcon Ratio at Week 12|Immune-cell ratio after a 4 weeks off IL-2 per protocol
1114704|NCT00529035|O2|Outcome|Median Treg:Tcon Ratio at Week 8|Immune-cell ratio after 8 weeks of IL-2 therapy
1114705|NCT00529035|O1|Outcome|Median Treg:Tcon Ratio at Baseline|Immune-cell ratio before the start of IL-2 therapy
1114706|NCT00529035|O3|Outcome|Median Absolute Cell Count at Week 12|Immune-cell counts after a 4 weeks off IL-2 per protocol
1114707|NCT00529035|O2|Outcome|Median Absolute Cell Counts at Week 8|Immune-cell counts after 8 weeks of IL-2 therapy
1114708|NCT00529035|O1|Outcome|Median Absolute Cell Counts at Baseline|Immune-cell counts before the start of IL-2 therapy
1114709|NCT00529035|O1|Outcome|Ultra-low Dose Interleukin-2|
1114710|NCT00529035|O1|Outcome|Ultra-low Dose IL-2 MTD|
1114711|NCT00529035|E1|Reported Event|Ultra-low Dose Interleukin-2|
1114712|NCT00528957|B3|Baseline|Total|Total of all reporting groups
1114713|NCT00528957|B2|Baseline|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
1114714|NCT00528957|B1|Baseline|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
1114715|NCT00528957|P2|Participant Flow|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
1114716|NCT00528957|P1|Participant Flow|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
1114717|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
1114718|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
1114719|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
1114720|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
1114721|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
1114722|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
1114723|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
1114724|NCT00528957|O2|Outcome|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks).
1114725|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks).
1114726|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
1114727|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
1114728|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
1114729|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
1114730|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
1114731|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
1114732|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
1114733|NCT00528957|O2|Outcome|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks).
1114734|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks).
1114735|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
1114736|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
1114737|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
1114738|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
1114739|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
1114740|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
1114741|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
1114742|NCT00528957|O2|Outcome|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks)
1114743|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks)
1116931|NCT00524264|O2|Outcome|Vehicle Solution|
1114744|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases (All TDF group)
1114745|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)
1114746|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s)
1114747|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
1114748|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)
1114749|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
1114750|NCT00528957|O2|Outcome|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks)
1114751|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks)
1114752|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
1114753|NCT00528957|O2|Outcome|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks)
1114754|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks)
1114755|NCT00528957|E3|Reported Event|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
1114756|NCT00528957|E2|Reported Event|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks)
1114757|NCT00528957|E1|Reported Event|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks)
1114758|NCT00528931|B1|Baseline|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into either the metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint
1114759|NCT00528931|P1|Participant Flow|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into either the metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint
1114760|NCT00528931|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into either the MP or PIP joint
1115552|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
1114761|NCT00528931|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into either the MP or PIP joint
1114762|NCT00528931|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into either the MP or PIP joint
1114763|NCT00528931|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into either the MP or PIP joint
1114764|NCT00528931|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into either the metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint
1114765|NCT00528931|E1|Reported Event|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into either the metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint
1114766|NCT00528879|B5|Baseline|Total|Total of all reporting groups
1114767|NCT00528879|B4|Baseline|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114768|NCT00528879|B3|Baseline|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114769|NCT00528879|B2|Baseline|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114770|NCT00528879|B1|Baseline|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114771|NCT00528879|P4|Participant Flow|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114772|NCT00528879|P3|Participant Flow|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114773|NCT00528879|P2|Participant Flow|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114774|NCT00528879|P1|Participant Flow|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114775|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114776|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114777|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114778|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114779|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114780|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114781|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114782|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114783|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114784|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1116932|NCT00524264|O1|Outcome|Ketorolac Solution|
1114785|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114786|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114787|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114788|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114789|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114790|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114791|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114792|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114793|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114794|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114795|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114796|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114797|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114798|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114799|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1115553|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
1114800|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114801|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114802|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114803|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114804|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114805|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114806|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114807|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114808|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114809|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114810|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114811|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114812|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114813|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114814|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114815|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114816|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114817|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114818|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114819|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114820|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114821|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114861|NCT00528801|O1|Outcome|Phase I: Cases|These are patients diagnosed with sickle cell disease (confirmed by hemoglobin electrophoresis).
1114822|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114823|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114824|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114825|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114826|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114827|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114828|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114829|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114830|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114831|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114832|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114833|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114834|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114835|NCT00528879|E4|Reported Event|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114836|NCT00528879|E3|Reported Event|Dapagliflozin, 5.0 mg + Metformin|Participants received dapagliflozin, 5.0 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114837|NCT00528879|E2|Reported Event|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114838|NCT00528879|E1|Reported Event|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
1114839|NCT00528866|B1|Baseline|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
1114840|NCT00528866|P1|Participant Flow|Androgen Suppression + RT + Docetaxel|Luteinizing hormone-releasing hormone (LHRH) agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
1114841|NCT00528866|O1|Outcome|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
1114842|NCT00528866|O1|Outcome|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
1114843|NCT00528866|O1|Outcome|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
1114844|NCT00528866|O1|Outcome|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
1114845|NCT00528866|O1|Outcome|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
1114846|NCT00528866|O1|Outcome|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
1114847|NCT00528866|O1|Outcome|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
1114848|NCT00528866|O1|Outcome|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
1114849|NCT00528866|O1|Outcome|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
1114850|NCT00528866|E1|Reported Event|Androgen Suppression + RT + Docetaxel|LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
1114851|NCT00528840|B1|Baseline|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
1114852|NCT00528840|P1|Participant Flow|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
1114853|NCT00528840|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
1114854|NCT00528840|E1|Reported Event|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
1114855|NCT00528801|B3|Baseline|Total|Total of all reporting groups
1114856|NCT00528801|B2|Baseline|Phase I: Controls|These are patients that do not have sickle cell disease (confirmed by hemoglobin electrophoresis); matched to cases by age, gender, and education level
1114857|NCT00528801|B1|Baseline|Phase I: Cases|These are patients diagnosed with sickle cell disease (confirmed by hemoglobin electrophoresis).
1114858|NCT00528801|P2|Participant Flow|Phase I: Controls|These are patients that do not have sickle cell disease (confirmed by hemoglobin electrophoresis); matched to cases by age, gender, and education level
1114859|NCT00528801|P1|Participant Flow|Phase I: Cases|These are patients diagnosed with sickle cell disease (confirmed by hemoglobin electrophoresis).
1114860|NCT00528801|O2|Outcome|Phase I: Controls|These are patients that do not have sickle cell disease (confirmed by hemoglobin electrophoresis); matched to cases by age, gender, and education level
1114955|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
1114862|NCT00528801|O2|Outcome|Phase I: Controls|These are patients that do not have sickle cell disease (confirmed by hemoglobin electrophoresis); matched to cases by age, gender, and education level
1114863|NCT00528801|O1|Outcome|Phase I: Cases|These are patients diagnosed with sickle cell disease (confirmed by hemoglobin electrophoresis).
1114864|NCT00528801|O2|Outcome|Phase I: Controls|These are patients that do not have sickle cell disease (confirmed by hemoglobin electrophoresis); matched to cases by age, gender, and education level
1114865|NCT00528801|O1|Outcome|Phase I: Cases|These are patients diagnosed with sickle cell disease (confirmed by hemoglobin electrophoresis).
1114866|NCT00528801|E2|Reported Event|Phase I: Controls|These are patients that do not have sickle cell disease (confirmed by hemoglobin electrophoresis); matched to cases by age, gender, and education level
1114867|NCT00528801|E1|Reported Event|Phase I: Cases|These are patients diagnosed with sickle cell disease (confirmed by hemoglobin electrophoresis).
1114868|NCT00528788|B1|Baseline|Pre-post Comparison|"ESRD: all patients with secondary hyperparathyroidism who are vitamin D naive~doxercalciferol : 2 or 4 mcg"
1114869|NCT00528788|P1|Participant Flow|Pre Doxercalciferol/Post Doxercalciferol|"all end stage renal disease patients with secondary hyperparathyroidism who are vitamin D naive~compared pre- and post doxercalciferol."
1114870|NCT00528788|O1|Outcome|Pre-post Comparison|"ESRD: all patients with secondary hyperparathyroidism who are vitamin D naive~doxercalciferol"
1114871|NCT00528788|E1|Reported Event|Pre and Post Doxicalciferol|"ESRD: all patients with secondary hyperparathyroidism who are vitamin D naive~doxercalciferol 2 mcg or 4 mcg three times per week for 1 month"
1114872|NCT00528775|B1|Baseline|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.~HPPH: 4 mg/m2 IV~endoscopic procedure: Treatment with 150 joules from laser"
1114873|NCT00528775|P1|Participant Flow|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.~HPPH: 4 mg/m2 IV~endoscopic procedure: Treatment with 150 joules from laser"
1114874|NCT00528775|O1|Outcome|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.~HPPH: 4 mg/m2 IV~endoscopic procedure: Treatment with 150 joules from laser"
1114875|NCT00528775|O1|Outcome|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.~HPPH: 4 mg/m2 IV~endoscopic procedure: Treatment with 150 joules from laser"
1114876|NCT00528775|O1|Outcome|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.~HPPH: 4 mg/m2 IV~endoscopic procedure: Treatment with 150 joules from laser"
1114877|NCT00528775|O1|Outcome|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.~HPPH: 4 mg/m2 IV~endoscopic procedure: Treatment with 150 joules from laser"
1114878|NCT00528775|O1|Outcome|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.~HPPH: 4 mg/m2 IV~endoscopic procedure: Treatment with 150 joules from laser"
1114879|NCT00528775|E1|Reported Event|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.~HPPH: 4 mg/m2 IV~endoscopic procedure: Treatment with 150 joules from laser"
1114880|NCT00528645|B1|Baseline|Treatment (Saracatinib)|"Patients receive oral AZD0530 once daily for up to 2 years in the absence of disease progression or unacceptable toxicity. Blood samples are obtained at baseline and periodically during study to determine levels of circulating tumor cells for defined translational studies.~saracatinib : saracatinib 175mg given orally daily with re-treatment every 3 weeks"
1114881|NCT00528645|P1|Participant Flow|Treatment (Saracatinib)|"Patients receive oral AZD0530 once daily for up to 2 years in the absence of disease progression or unacceptable toxicity.~saracatinib : saracatinib 175mg given orally daily with re-treatment every 3 weeks"
1114882|NCT00528645|O1|Outcome|Treatment (Saracatinib)|"Patients receive oral AZD0530 once daily for up to 2 years in the absence of disease progression or unacceptable toxicity.~saracatinib: saracatinib 175mg given orally daily with re-treatment every 3 weeks"
1114883|NCT00528645|E1|Reported Event|Treatment (Saracatinib)|saracatinib : saracatinib 175mg given orally daily with re-treatment every 3 weeks
1114884|NCT00528606|B3|Baseline|Total|Total of all reporting groups
1114885|NCT00528606|B2|Baseline|Placebo|
1114886|NCT00528606|B1|Baseline|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
1114887|NCT00528606|P2|Participant Flow|Placebo|
1114888|NCT00528606|P1|Participant Flow|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
1114889|NCT00528606|O2|Outcome|Placebo|
1114890|NCT00528606|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
1114891|NCT00528606|E2|Reported Event|Placebo|
1114892|NCT00528606|E1|Reported Event|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
1114893|NCT00528567|B3|Baseline|Total|Total of all reporting groups
1114894|NCT00528567|B2|Baseline|Chemotherapy|Participants randomized to receive chemotherapy alone
1114895|NCT00528567|B1|Baseline|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
1114896|NCT00528567|P2|Participant Flow|Chemotherapy|"Participants randomized to receive chemotherapy alone.~For patients randomized to the chemotherapy alone arm, investigators could select from one of three chemotherapy regimens. After completing chemotherapy (treatment period 1) patients entered a post-treatment surveillance period for the remainder of the first year after randomization (treatment period 2).~At the end of treatment (i.e., after approximately 55 weeks), patients were followed up until the end of the study."
1114956|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
1114957|NCT00528541|E2|Reported Event|Dysport®|botulinum toxin type A (Dysport®)
1114897|NCT00528567|P1|Participant Flow|Bevacizumab and Chemotherapy|"Participants randomized to receive bevacizumab and chemotherapy.~For these patients, bevacizumab was given in combination with chemotherapy at a dose of 5 mg/kg/week equivalent using 1 of 3 different scheduling options depending on the schedule of the adjuvant chemotherapy selected. After completing chemotherapy + bevacizumab (treatment period 1), patients in this arm received bevacizumab monotherapy up to a total duration of 1 year (treatment period 2).~At the end of treatment (i.e., after approximately 55 weeks), patients were followed up until the end of the study."
1114898|NCT00528567|O4|Outcome|Chemotherapy (>18 Months)|Occurring in participants who received chemotherapy alone, more than 18 months after first dose
1114899|NCT00528567|O3|Outcome|Bevacizumab and Chemotherapy (>18 Months)|Occurring in participants who received bevacizumab and chemotherapy, more than 18 months after first dose
1114900|NCT00528567|O2|Outcome|Chemotherapy (0-18 Months)|Occurring in participants who received chemotherapy alone, 0-18 months after first dose
1114901|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy (0-18 Months)|Occurring in participants who received bevacizumab and chemotherapy, 0-18 months after first dose
1114902|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
1114903|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
1114904|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
1114905|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
1114906|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
1114907|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
1114908|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
1114909|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
1114910|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
1114911|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
1114912|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
1114913|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
1114914|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy
1114915|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
1114916|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
1114917|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
1114919|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
1114920|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
1114921|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
1114922|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
1114923|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
1114924|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy
1114925|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
1114926|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy
1114927|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
1114928|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
1114929|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
1114930|NCT00528567|E4|Reported Event|Chemotherapy (>18 Months)|Occurring in participants who received chemotherapy alone, during follow-up period (>18 months) after first dose
1114931|NCT00528567|E3|Reported Event|Bevacizumab and Chemotherapy (>18 Months)|Occurring in participants who received bevacizumab and chemotherapy, during follow-up period (>18 months) after first dose
1114932|NCT00528567|E2|Reported Event|Chemotherapy (0-18 Months)|Occurring in participants who received chemotherapy alone, during treatment period (0-18 months) after first dose
1114933|NCT00528567|E1|Reported Event|Bevacizumab and Chemotherapy (0-18 Months)|Occurring in participants who received bevacizumab and chemotherapy, during treatment period (0-18 months) after first dose
1114934|NCT00528541|B3|Baseline|Total|Total of all reporting groups
1114935|NCT00528541|B2|Baseline|Dysport®|botulinum toxin type A (Dysport®)
1114936|NCT00528541|B1|Baseline|BOTOX®|botulinum toxin type A (BOTOX®)
1114937|NCT00528541|P2|Participant Flow|Dysport®|botulinum toxin type A (Dysport®)
1114938|NCT00528541|P1|Participant Flow|BOTOX®|botulinum toxin type A (BOTOX®)
1114939|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
1114940|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
1114941|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
1114942|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
1114943|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
1114944|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
1114945|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
1114946|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
1114947|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
1114948|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
1114949|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
1114950|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
1114951|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
1114952|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
1114953|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
1114954|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
1114958|NCT00528541|E1|Reported Event|BOTOX®|botulinum toxin type A (BOTOX®)
1114959|NCT00528528|B5|Baseline|Total|Total of all reporting groups
1114960|NCT00528528|B4|Baseline|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
1114961|NCT00528528|B3|Baseline|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
1114962|NCT00528528|B2|Baseline|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
1114963|NCT00528528|B1|Baseline|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
1114964|NCT00528528|P4|Participant Flow|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
1114965|NCT00528528|P3|Participant Flow|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
1114966|NCT00528528|P2|Participant Flow|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
1115015|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1114967|NCT00528528|P1|Participant Flow|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
1114968|NCT00528528|O4|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
1114969|NCT00528528|O3|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
1114970|NCT00528528|O2|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
1114971|NCT00528528|O1|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
1114972|NCT00528528|O4|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
1114973|NCT00528528|O3|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
1114974|NCT00528528|O2|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
1114975|NCT00528528|O1|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
1114976|NCT00528528|O4|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
1114977|NCT00528528|O3|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
1115038|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1116933|NCT00524264|O2|Outcome|Vehicle Solution|
1114978|NCT00528528|O2|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
1114979|NCT00528528|O1|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
1114980|NCT00528528|O4|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
1114981|NCT00528528|O3|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
1114982|NCT00528528|O2|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
1114983|NCT00528528|O1|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
1114984|NCT00528528|O4|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
1114985|NCT00528528|O3|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
1114986|NCT00528528|O2|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
1114987|NCT00528528|O1|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
1114988|NCT00528528|O4|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
1114989|NCT00528528|O3|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
1114990|NCT00528528|O2|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
1114991|NCT00528528|O1|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
1114992|NCT00528528|O4|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
1114993|NCT00528528|O3|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
1114994|NCT00528528|O2|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
1114995|NCT00528528|O1|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
1114996|NCT00528528|E4|Reported Event|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
1115039|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115040|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1114997|NCT00528528|E3|Reported Event|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
1114998|NCT00528528|E2|Reported Event|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
1114999|NCT00528528|E1|Reported Event|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
1115000|NCT00528450|B1|Baseline|All Patients|Tretinoin and Arsenic Trioxide With or Without Idarubicin
1115001|NCT00528450|P1|Participant Flow|All Patients|Tretinoin and Arsenic Trioxide With or Without Idarubicin
1115002|NCT00528450|O1|Outcome|All Patients|Tretinoin and Arsenic Trioxide With or Without Idarubicin
1115003|NCT00528450|E1|Reported Event|All Patients|Tretinoin and Arsenic Trioxide With or Without Idarubicin
1115004|NCT00528424|B1|Baseline|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
1115005|NCT00528424|P1|Participant Flow|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
1115006|NCT00528424|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
1115007|NCT00528424|E1|Reported Event|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
1115008|NCT00528411|B4|Baseline|Total|Total of all reporting groups
1115009|NCT00528411|B3|Baseline|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115010|NCT00528411|B2|Baseline|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115011|NCT00528411|B1|Baseline|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus Clopidogrel placebo loading and od maintenance doses
1115012|NCT00528411|P3|Participant Flow|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg Twice Daily (bd), plus clopidogrel placebo loading and Once Daily (od) maintenance doses
1115013|NCT00528411|P2|Participant Flow|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg Twice Daily (od), plus ticagrelor placebo loading and Once Daily (bd) maintenance doses
1115014|NCT00528411|P1|Participant Flow|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg Twice Daily (bd), plus clopidogrel placebo loading and Once Daily (od) maintenance doses
1115016|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115017|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115018|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115019|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115020|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115021|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115022|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115023|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115024|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115025|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115026|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115027|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115028|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115029|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115030|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115031|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115032|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115033|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115034|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115035|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115036|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115037|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115784|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
1115041|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115042|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115043|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115044|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115045|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115046|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115047|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115048|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115049|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115050|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115051|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115052|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115053|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115054|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115055|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115056|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115057|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115058|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115059|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115554|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
1115060|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115061|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115062|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115063|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115064|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115065|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115066|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115067|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115068|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115069|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115070|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115071|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115072|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115073|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115074|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115075|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115076|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115077|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115078|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115079|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115080|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115081|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115082|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115083|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115084|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115085|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115086|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115087|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115088|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115089|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115090|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115091|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115092|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115093|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115094|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115095|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115096|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115097|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115098|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115099|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115100|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115101|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115102|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115103|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115555|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
1115104|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115105|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115106|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115107|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115108|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115109|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115110|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115111|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115112|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115113|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115114|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115115|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115116|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115117|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115118|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115119|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115120|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115121|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115122|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115123|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115124|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115125|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115126|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115127|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115128|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115129|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115130|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115131|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115132|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115133|NCT00528411|E3|Reported Event|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115134|NCT00528411|E2|Reported Event|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
1115135|NCT00528411|E1|Reported Event|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
1115136|NCT00528398|B1|Baseline|Treatment (Idarubicin, Cytarabine)|All patients were analyzed together.
1115137|NCT00528398|P1|Participant Flow|Treatment (Idarubicin, Cytarabine)|All patients were analyzed together.
1115138|NCT00528398|O1|Outcome|Treatment (Idarubicin, Cytarabine)|All patients were analyzed together.
1115139|NCT00528398|O1|Outcome|Treatment (Idarubicin, Cytarabine)|All patients were analyzed together.
1115140|NCT00528398|E1|Reported Event|Treatment (Idarubicin, Cytarabine)|All patients were analyzed together.
1115141|NCT00528372|B10|Baseline|Total|Total of all reporting groups
1115142|NCT00528372|B9|Baseline|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115143|NCT00528372|B8|Baseline|Group 2: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115144|NCT00528372|B7|Baseline|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115145|NCT00528372|B6|Baseline|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115299|NCT00527111|O2|Outcome|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil~5-fluorouracil~Pelvic irradiation"
1115146|NCT00528372|B5|Baseline|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115147|NCT00528372|B4|Baseline|Group 1: Dapagliflozin, 10 mg AM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, AM, once each morning for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
1115148|NCT00528372|B3|Baseline|Group 1: Dapagliflozin, 5 mg AM|Participants with (HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115149|NCT00528372|B2|Baseline|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115150|NCT00528372|B1|Baseline|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115151|NCT00528372|P9|Participant Flow|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115152|NCT00528372|P8|Participant Flow|Group 2: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115153|NCT00528372|P7|Participant Flow|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115154|NCT00528372|P6|Participant Flow|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115155|NCT00528372|P5|Participant Flow|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115177|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, PM, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115156|NCT00528372|P4|Participant Flow|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115157|NCT00528372|P3|Participant Flow|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115158|NCT00528372|P2|Participant Flow|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115159|NCT00528372|P1|Participant Flow|Group 1: Dapagliflozin Placebo|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115160|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115161|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115162|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115163|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115164|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with (HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115165|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115166|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115167|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, PM, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115168|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, PM, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115169|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
1115170|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115171|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115172|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115173|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115174|NCT00528372|O9|Outcome|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115175|NCT00528372|O8|Outcome|Group 2: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115176|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, PM, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115178|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, PM, once each evening for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
1115179|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115180|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115181|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115182|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115183|NCT00528372|O2|Outcome|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115184|NCT00528372|O1|Outcome|Group 2: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115185|NCT00528372|O9|Outcome|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115186|NCT00528372|O8|Outcome|Group 2: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115187|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115188|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115189|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115190|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115191|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115192|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115193|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo, AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115194|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115195|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115196|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115197|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115198|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with (HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115199|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115200|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115201|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115202|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115203|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115204|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115205|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115206|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115207|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115556|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
1115208|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115209|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115210|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115211|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115212|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115213|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115214|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115215|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115216|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115217|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115218|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115219|NCT00528372|O3|Outcome|Group 1: Dapaglifozon, 5 mg AM|Participants with (HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115220|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with hemoglobin A1c (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks.Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115221|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115222|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115223|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115224|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115225|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, AM, once each morning for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
1115226|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, AM, once each morning for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
1115227|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, AM, once each morning for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
1127296|NCT00494221|O1|Outcome|Cediranib 20 mg|FOLFOX + Cediranib 20 mg
1115228|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|"Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
1115229|NCT00528372|O2|Outcome|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115230|NCT00528372|O1|Outcome|Group 2: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115231|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115232|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115233|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115234|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115235|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115236|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115237|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115324|NCT00526994|P2|Participant Flow|Universal Education (All Referred)|"receives referral information~universal education : receives referral information"
1115374|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
1115238|NCT00528372|O2|Outcome|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115239|NCT00528372|O1|Outcome|Group 2: Dapagliflozin, 5 mg AM|Participants with hemoglobin A1c (HbA1c) ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115240|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115241|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115242|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115243|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115244|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115245|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115246|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115300|NCT00527111|O1|Outcome|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab~Cetuximab~5-fluorouracil~Pelvic irradiation"
1127297|NCT00494221|E3|Reported Event|Placebo|Placebo
1115247|NCT00528372|O2|Outcome|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115248|NCT00528372|O1|Outcome|Group 2: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115249|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115250|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115251|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115252|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115253|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115254|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115255|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115325|NCT00526994|P1|Participant Flow|Screened & Referred|"Screened w/4 questions on intimate partner violence; if positive, receives referral information~screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information"
1115326|NCT00526994|O3|Outcome|Control|no screen and no referral
1115256|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115257|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115258|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
1115259|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115260|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115261|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115262|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115263|NCT00528372|E7|Reported Event|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115264|NCT00528372|E6|Reported Event|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115265|NCT00528372|E5|Reported Event|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115266|NCT00528372|E4|Reported Event|Group 1: Dapagliflozin, 10 mg AM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
1115301|NCT00527111|O2|Outcome|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil~5-fluorouracil~Pelvic irradiation"
1115267|NCT00528372|E3|Reported Event|Group 1: Dapagliflozin, 5 mg AM|Participants with (HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115268|NCT00528372|E2|Reported Event|Group 1: Dapagliflozin, 2.5 mg AM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
1115269|NCT00528372|E1|Reported Event|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
1115270|NCT00528268|B3|Baseline|Total|Total of all reporting groups
1115271|NCT00528268|B2|Baseline|Cohort 2|"Family history of SMA type II 0-6 months old Confirmation of no more than 4 SMN2 copies~Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
1115272|NCT00528268|B1|Baseline|Cohort 1|"Family history of SMA type I 0-3 months old Confirmation of no more than 3 SMN2 copies~Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
1115273|NCT00528268|P2|Participant Flow|Cohort 2|"Family history of SMA type II 0-6 months old Confirmation of no more than 4 SMN2 copies~Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
1115274|NCT00528268|P1|Participant Flow|Cohort 1|"Family history of SMA type I 0-3 months old Confirmation of no more than 3 SMN2 copies~Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
1115275|NCT00528268|O2|Outcome|Cohort 2|"Family history of SMA type II 0-6 months old Confirmation of no more than 4 SMN2 copies~Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
1115327|NCT00526994|O2|Outcome|Universal Education (All Referred)|"receives referral information~universal education : receives referral information"
1115375|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
1115276|NCT00528268|O1|Outcome|Cohort 1|"Family history of SMA type I 0-3 months old Confirmation of no more than 3 SMN2 copies~Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
1115277|NCT00528268|E2|Reported Event|Cohort 2|"Family history of SMA type II 0-6 months old Confirmation of no more than 4 SMN2 copies~Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
1115278|NCT00528268|E1|Reported Event|Cohort 1|"Family history of SMA type I 0-3 months old Confirmation of no more than 3 SMN2 copies~Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
1115279|NCT00527124|B3|Baseline|Total|Total of all reporting groups
1115280|NCT00527124|B2|Baseline|Arm II|Patients receive docetaxel and prednisone as in arm I.
1115281|NCT00527124|B1|Baseline|Arm I|Patients receive oral cediranib once daily on days 1-21, docetaxel IV over 1 hour on day 1, and oral prednisone twice daily on days 1-21.
1115282|NCT00527124|P2|Participant Flow|Arm II|Patients receive docetaxel and prednisone as in arm I.
1115283|NCT00527124|P1|Participant Flow|Arm I|Patients receive oral cediranib once daily on days 1-21, docetaxel IV over 1 hour on day 1, and oral prednisone twice daily on days 1-21.
1115284|NCT00527124|O2|Outcome|Arm II|Patients receive docetaxel 75 mg/m2 IV every 3 weeks, and prednisone 5mg orally twice a day, Repeat cycle every 21 days.
1115285|NCT00527124|O1|Outcome|Arm I|Patients receive oral cediranib 20 mg once daily on days 1-21, docetaxel 75mg/m2 IV over 1 hour on day 1 every 3 weeks, and oral prednisone 5mg twice daily on days 1-21.
1115286|NCT00527124|E2|Reported Event|Arm II|Patients receive docetaxel and prednisone as in arm I.
1115287|NCT00527124|E1|Reported Event|Arm I|Patients receive oral cediranib once daily on days 1-21, docetaxel IV over 1 hour on day 1, and oral prednisone twice daily on days 1-21.
1115288|NCT00527111|B3|Baseline|Total|Total of all reporting groups
1115289|NCT00527111|B2|Baseline|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil~5-fluorouracil~Pelvic irradiation"
1115290|NCT00527111|B1|Baseline|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab~Cetuximab~5-fluorouracil~Pelvic irradiation"
1115291|NCT00527111|P2|Participant Flow|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil~5-fluorouracil~Pelvic irradiation"
1115292|NCT00527111|P1|Participant Flow|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab~Cetuximab~5-fluorouracil~Pelvic irradiation"
1115293|NCT00527111|O2|Outcome|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil~5-fluorouracil~Pelvic irradiation"
1115294|NCT00527111|O1|Outcome|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab~Cetuximab~5-fluorouracil~Pelvic irradiation"
1115295|NCT00527111|O2|Outcome|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil~5-fluorouracil~Pelvic irradiation"
1115296|NCT00527111|O1|Outcome|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab~Cetuximab~5-fluorouracil~Pelvic irradiation"
1115297|NCT00527111|O2|Outcome|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil~5-fluorouracil~Pelvic irradiation"
1115298|NCT00527111|O1|Outcome|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab~Cetuximab~5-fluorouracil~Pelvic irradiation"
1127298|NCT00494221|E2|Reported Event|Cediranib 30 mg|Cediranib 30 mg
1115302|NCT00527111|O1|Outcome|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab~Cetuximab~5-fluorouracil~Pelvic irradiation"
1115303|NCT00527111|E2|Reported Event|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil~5-fluorouracil~Pelvic irradiation"
1115304|NCT00527111|E1|Reported Event|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab~Cetuximab~5-fluorouracil~Pelvic irradiation"
1115305|NCT00527098|B3|Baseline|Total|Total of all reporting groups
1115306|NCT00527098|B2|Baseline|Standard of Care|Routine Standard of Care Resuscitation Fluid
1115307|NCT00527098|B1|Baseline|Hextend Plus Standard of Care|Hextend along with the routine Standard of Care Resuscitation Fluid
1115308|NCT00527098|P2|Participant Flow|Standard of Care|Routine Standard of Care Resuscitation Fluid
1115309|NCT00527098|P1|Participant Flow|Hextend Plus Standard of Care|Hextend along with the routine Standard of Care Resuscitation Fluid
1115310|NCT00527098|O1|Outcome|Observational|This is an observational trial.
1115311|NCT00527098|E2|Reported Event|Standard of Care|Routine Standard of Care Resuscitation Fluid
1115312|NCT00527098|E1|Reported Event|Hextend Plus Standard of Care|Hextend along with the routine Standard of Care Resuscitation Fluid
1115313|NCT00527072|B1|Baseline|Infliximab|Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
1115314|NCT00527072|P1|Participant Flow|Infliximab|Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
1115315|NCT00527072|O1|Outcome|Infliximab|Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
1115316|NCT00527072|O1|Outcome|Infliximab|Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
1115317|NCT00527072|O1|Outcome|Infliximab|Open-label study, patients received IV infusions of 5 mg/kg infliximab at Weeks 0, 2, 6, 14, and 22
1115318|NCT00527072|E1|Reported Event|Infliximab|Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
1115319|NCT00526994|B4|Baseline|Total|Total of all reporting groups
1115320|NCT00526994|B3|Baseline|Control|no screen and no referral
1115321|NCT00526994|B2|Baseline|Universal Education (All Referred)|"receives referral information~universal education : receives referral information"
1115322|NCT00526994|B1|Baseline|Screened & Referred|"Screened w/4 questions on intimate partner violence; if positive, receives referral information~screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information"
1115323|NCT00526994|P3|Participant Flow|Control|no screen and no referral
1116934|NCT00524264|O1|Outcome|Ketorolac Solution|
1115328|NCT00526994|O1|Outcome|Screened & Referred|"Screened w/4 questions on intimate partner violence; if positive, receives referral information~screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information"
1115329|NCT00526994|O3|Outcome|Control|no screen and no referral
1115330|NCT00526994|O2|Outcome|Universal Education (All Referred)|"receives referral information~universal education : receives referral information"
1115331|NCT00526994|O1|Outcome|Screened & Referred|"Screened w/4 questions on intimate partner violence; if positive, receives referral information~screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information"
1115332|NCT00526994|O3|Outcome|Control|no screen and no referral
1115333|NCT00526994|O2|Outcome|Universal Education (All Referred)|"receives referral information~universal education : receives referral information"
1115334|NCT00526994|O1|Outcome|Screened & Referred|"Screened w/4 questions on intimate partner violence; if positive, receives referral information~screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information"
1115335|NCT00526994|O3|Outcome|Control|no screen and no referral
1115336|NCT00526994|O2|Outcome|Universal Education (All Referred)|"receives referral information~universal education : receives referral information"
1115337|NCT00526994|O1|Outcome|Screened & Referred|"Screened w/4 questions on intimate partner violence; if positive, receives referral information~screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information"
1115338|NCT00526994|E3|Reported Event|Control|no screen and no referral
1115339|NCT00526994|E2|Reported Event|Universal Education (All Referred)|"receives referral information~universal education : receives referral information"
1115340|NCT00526994|E1|Reported Event|Screened & Referred|"Screened w/4 questions on intimate partner violence; if positive, receives referral information~screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information"
1115341|NCT00528190|B3|Baseline|Total|Total of all reporting groups
1115342|NCT00528190|B2|Baseline|Placebo|Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
1115343|NCT00528190|B1|Baseline|Itraconazole|"Itraconazole 5mg/kg/day~Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks"
1115344|NCT00528190|P2|Participant Flow|Placebo|Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
1115345|NCT00528190|P1|Participant Flow|Itraconazole|"Itraconazole 5mg/kg/day~Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks"
1115346|NCT00528190|O2|Outcome|Placebo|Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
1115347|NCT00528190|O1|Outcome|Itraconazole|"Itraconazole 5mg/kg/day~Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks"
1115348|NCT00528190|E2|Reported Event|Placebo|Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks
1115349|NCT00528190|E1|Reported Event|Itraconazole|"Itraconazole 5mg/kg/day~Itraconazole: Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks"
1115350|NCT00528112|B3|Baseline|Total|Total of all reporting groups
1115351|NCT00528112|B2|Baseline|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
1115352|NCT00528112|B1|Baseline|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
1115353|NCT00528112|P2|Participant Flow|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro. Treatment up to 5 years.
1115354|NCT00528112|P1|Participant Flow|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro. Treatment up to 3 years.
1115355|NCT00528112|O1|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
1115356|NCT00528112|O1|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
1115357|NCT00528112|O1|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
1115358|NCT00528112|O1|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
1115359|NCT00528112|O1|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
1115360|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
1115361|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
1115362|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
1115363|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
1115364|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
1115365|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
1115366|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
1115367|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
1115368|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
1115369|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
1115370|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
1115371|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
1115372|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
1115373|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
1115376|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
1115377|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
1115378|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
1115379|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
1115380|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
1115381|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
1115382|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
1115383|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
1115384|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
1115385|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
1115386|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
1115387|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
1115388|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
1115389|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
1115390|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
1115391|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
1115392|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
1115393|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
1115394|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
1115395|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
1115396|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
1115557|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
1115397|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
1115398|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
1115399|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
1115400|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
1115401|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
1115402|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
1115403|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
1115404|NCT00528112|E3|Reported Event|LCS16, up to 5 Years|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro. Treatment up to 5 years.
1115405|NCT00528112|E2|Reported Event|LCS16, up to 3 Years|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro. Treatment up to 3 years.
1115406|NCT00528112|E1|Reported Event|LCS12, up to 3 Years|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro. Treatment up to 3 years.
1115407|NCT00528021|B5|Baseline|Total|Total of all reporting groups
1115408|NCT00528021|B4|Baseline|Vehicle|
1115409|NCT00528021|B3|Baseline|12.5% BGC20-0582|
1115410|NCT00528021|B2|Baseline|10% BGC20-0582|
1115411|NCT00528021|B1|Baseline|2.5% BGC20-0582|
1115412|NCT00528021|P4|Participant Flow|Vehicle|
1115413|NCT00528021|P3|Participant Flow|12.5% BGC20-0582|
1115414|NCT00528021|P2|Participant Flow|10% BGC20-0582|
1115415|NCT00528021|P1|Participant Flow|2.5% BGC20-0582|
1115416|NCT00528021|O4|Outcome|Vehicle|
1115417|NCT00528021|O3|Outcome|12.5% BGC20-0582|
1115418|NCT00528021|O2|Outcome|10% BGC20-0582|
1115419|NCT00528021|O1|Outcome|2.5% BGC20-0582|
1115420|NCT00528021|E4|Reported Event|Vehicle|
1115421|NCT00528021|E3|Reported Event|12.5% BGC20-0582|
1115422|NCT00528021|E2|Reported Event|10% BGC20-0582|
1115423|NCT00528021|E1|Reported Event|2.5% BGC20-0582|
1115424|NCT00527982|B3|Baseline|Total|Total of all reporting groups
1115425|NCT00527982|B2|Baseline|No Treatment|
1115426|NCT00527982|B1|Baseline|Celecoxib Treatment|Celecoxib 600 mg orally daily
1115427|NCT00527982|P2|Participant Flow|No Treatment|
1115428|NCT00527982|P1|Participant Flow|Celecoxib Treatment|Celecoxib 600 mg orally daily
1115429|NCT00527982|O2|Outcome|No Treatment|
1115430|NCT00527982|O1|Outcome|Celecoxib Treatment|Celecoxib 600 mg orally daily
1115431|NCT00527982|E2|Reported Event|No Treatment|
1115432|NCT00527982|E1|Reported Event|Celecoxib Treatment|Celecoxib 600 mg orally daily
1115433|NCT00527943|B3|Baseline|Total|Total of all reporting groups
1115656|NCT00527618|O2|Outcome|Valacyclovir|Valacyclovir, 1000 mg orally twice daily (assigned to the valacyclovir arm in either the first or second intervention periods)
1115434|NCT00527943|B2|Baseline|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1115435|NCT00527943|B1|Baseline|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1115436|NCT00527943|P2|Participant Flow|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1115437|NCT00527943|P1|Participant Flow|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1115438|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1115439|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1115440|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1115441|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1115442|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1115443|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1115444|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1115470|NCT00527904|O1|Outcome|PN400 (VIMOVO)|PN 400 (20 mg esomeprazole and 500 mg naproxen) dosed twice daily
1115558|NCT00527787|E2|Reported Event|Naproxen|Naproxen 500 mg
1115445|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1115446|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1115447|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1115448|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1115449|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1115450|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1115451|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1115452|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1115453|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1115454|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1115455|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1115456|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1116935|NCT00524264|O2|Outcome|Vehicle Solution|
1115457|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1115458|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1115459|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1115460|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1115461|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1115462|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1115463|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1115464|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1115465|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1115466|NCT00527943|E2|Reported Event|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1115467|NCT00527943|E1|Reported Event|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
1115468|NCT00527904|B1|Baseline|PN400 (VIMOVO)|PN 400 (20 mg esomeprazole and 500 mg naproxen) dosed twice daily
1115469|NCT00527904|P1|Participant Flow|PN400 (VIMOVO)|PN 400 (20 mg esomeprazole and 500 mg naproxen) dosed twice daily
1115471|NCT00527904|E1|Reported Event|PN400 (VIMOVO)|PN 400 (20 mg esomeprazole and 500 mg naproxen) dosed twice daily
1115472|NCT00527878|B1|Baseline|Patients|
1115473|NCT00527878|P2|Participant Flow|Ranitidine/Placebo|Ranitidine will be dosed orally at 150 mg twice daily for adults, and at 2-4 mg/kg/dose twice daily for children with a maximum dose of 150 mg twice daily. Liquid formulations will be provided for individuals unable to swallow pills. Subjects will be randomized to receive ranitidine for 12 months followed by 12 months of the ranitidine.
1115474|NCT00527878|P1|Participant Flow|Placebo/Ranitidine|Ranitidine will be dosed orally at 150 mg twice daily for adults, and at 2-4 mg/kg/dose twice daily for children with a maximum dose of 150 mg twice daily. Liquid formulations will be provided for individuals unable to swallow pills. Subjects will be randomized to receive placebo for 12 months followed by 12 months of the ranitidine.
1115475|NCT00527878|O2|Outcome|Ranitidine|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the treatment for both arms.
1115476|NCT00527878|O1|Outcome|Placebo|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the placebo for both arms.
1115477|NCT00527878|O2|Outcome|Ranitidine|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the treatment for both arms.
1115478|NCT00527878|O1|Outcome|Placebo|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the placebo for both arms.
1115479|NCT00527878|O2|Outcome|Ranitidine|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the treatment for both arms.
1115480|NCT00527878|O1|Outcome|Placebo|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the placebo for both arms.
1115481|NCT00527878|O2|Outcome|Ranitidine|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the treatment for both arms.
1115482|NCT00527878|O1|Outcome|Placebo|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the placebo for both arms.
1115483|NCT00527878|E2|Reported Event|Ranitidine|This was a crossover study and patients received 12 months of ranitidine and 12 months of placebo, unless they terminated the study.
1115484|NCT00527878|E1|Reported Event|Placebo|this was a crossover study and patients received both placebo and study drug (ranitidine), both of which for 12 months, unless they terminated the study.
1115485|NCT00527826|B3|Baseline|Total|Total of all reporting groups
1115486|NCT00527826|B2|Baseline|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
1115487|NCT00527826|B1|Baseline|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
1115657|NCT00527618|O1|Outcome|Acyclovir|Acyclovir, 400 mg orally twice daily (assigned to the acyclovir arm in either the first or second intervention periods)
1115488|NCT00527826|P2|Participant Flow|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
1115489|NCT00527826|P1|Participant Flow|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
1115490|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
1115491|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
1115492|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
1115493|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
1115494|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
1115495|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
1115496|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
1115497|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
1115498|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
1115499|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
1115500|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
1115501|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
1115502|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
1115503|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
1115504|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
1115505|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
1115506|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
1115507|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
1115508|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
1115509|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
1115510|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
1115511|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
1115512|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
1115513|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
1115514|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
1115515|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
1115516|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
1115517|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
1115518|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
1115519|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
1115520|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
1115521|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
1115782|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
1115522|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
1115523|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
1115524|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
1115525|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
1115526|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
1115527|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
1115528|NCT00527826|O3|Outcome|FP 500 µg|Fluticasone propionate (FP) 500 µg BID (morning and evening) from a separate inhaler (FLUTIDE forte Diskus)
1115529|NCT00527826|O2|Outcome|Sal 50 µg|Salmeterol xinafoate (Sal) 50 µg BID (morning and evening) from a separate inhaler (SEVERENT Diskus)
1115530|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
1115531|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
1115532|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
1115533|NCT00527826|E2|Reported Event|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
1115534|NCT00527826|E1|Reported Event|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
1115535|NCT00527787|B3|Baseline|Total|Total of all reporting groups
1115536|NCT00527787|B2|Baseline|Naproxen|Naproxen 500 mg
1115537|NCT00527787|B1|Baseline|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
1115538|NCT00527787|P2|Participant Flow|Naproxen|Naproxen 500 mg
1115539|NCT00527787|P1|Participant Flow|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
1115540|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
1115541|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
1115542|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
1115543|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
1115544|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
1115559|NCT00527787|E1|Reported Event|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
1115560|NCT00527748|B1|Baseline|Standard of Care or Ankle Exerciser|"Patient ankle range of motion will be assessed at clinic visit. They will either receive standard care physiotherapy, or use the ankle exerciser in the following manner:~Subjects will train using only one combination of movement, dorsiflexion with inversion. This is done by manipulating the ring so that the medial and anterior ropes are taut. Subject will start with 3 minute warm-up. Subject will then manipulate the ring so that the foot moves into dorsiflexion with inversion until a point of tolerable discomfort is felt; subject will hold this position for 30 seconds. Stretch will be repeated 10 times, each day, for six weeks.~Reassessment will be done at six weeks and 10 weeks.Patient ankle range of motion will be assessed at clinic visit. No stretching exercises with the device, but will be provided standard care through physiotherapist in acute cases, and no stretching exercises for chronic patients. Reassessment will be done at six weeks and 10 weeks."
1115561|NCT00527748|P1|Participant Flow|Standard of Care or Ankle Exerciser|"Patient ankle range of motion will be assessed at clinic visit. They will either receive standard care physiotherapy, or use the ankle exerciser in the following manner:~Subjects will train using only one combination of movement, dorsiflexion with inversion. This is done by manipulating the ring so that the medial and anterior ropes are taut. Subject will start with 3 minute warm-up. Subject will then manipulate the ring so that the foot moves into dorsiflexion with inversion until a point of tolerable discomfort is felt; subject will hold this position for 30 seconds. Stretch will be repeated 10 times, each day, for six weeks.~Reassessment will be done at six weeks and 10 weeks."
1115562|NCT00527748|O1|Outcome|Standard of Care|"Patient ankle range of motion will be assessed at clinic visit. No stretching exercises with the device, but will be provided standard care through physiotherapist in acute cases, and no stretching exercises for chronic patients. Reassessment will be done at six weeks and 10 weeks.Patient ankle range of motion will be assessed at clinic visit. They will either receive standard care physiotherapy, or use the ankle exerciser in the following manner:~Subjects will train using only one combination of movement, dorsiflexion with inversion. This is done by manipulating the ring so that the medial and anterior ropes are taut. Subject will start with 3 minute warm-up. Subject will then manipulate the ring so that the foot moves into dorsiflexion with inversion until a point of tolerable discomfort is felt; subject will hold this position for 30 seconds. Stretch will be repeated 10 times, each day, for six weeks.~Reassessment will be done at six weeks and 10 weeks."
1115583|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (sequential). The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes every 3 weeks as part of induction. Participants could also receive additional maintenance ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
1116936|NCT00524264|O1|Outcome|Ketorolac Solution|
1115563|NCT00527748|E1|Reported Event|Standard of Care or Ankle Exerciser|"Patient ankle range of motion will be assessed at clinic visit. No stretching exercises with the device, but will be provided standard care through physiotherapist in acute cases, and no stretching exercises for chronic patients. Reassessment will be done at six weeks and 10 weeks.Patient ankle range of motion will be assessed at clinic visit. They will either receive standard care physiotherapy, or use the ankle exerciser in the following manner:~Subjects will train using only one combination of movement, dorsiflexion with inversion. This is done by manipulating the ring so that the medial and anterior ropes are taut. Subject will start with 3 minute warm-up. Subject will then manipulate the ring so that the foot moves into dorsiflexion with inversion until a point of tolerable discomfort is felt; subject will hold this position for 30 seconds. Stretch will be repeated 10 times, each day, for six weeks.~Reassessment will be done at six weeks and 10 weeks."
1115564|NCT00527735|B4|Baseline|Total|Total of all reporting groups
1115565|NCT00527735|B3|Baseline|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who experienced clinical benefit on treatment phase without intolerable toxicity could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
1115566|NCT00527735|B2|Baseline|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (sequential). The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes every 3 weeks. Participants who experienced clinical benefit on treatment phase without intolerable toxicity were allowed to continue in the maintenance phase, receiving additional ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115567|NCT00527735|B1|Baseline|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (concurrent). The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes every 3 weeks. Participants who experienced clinical benefit on treatment phase without intolerable toxicity were allowed to continue in the maintenance phase, receiving additional ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115568|NCT00527735|P3|Participant Flow|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
1115569|NCT00527735|P2|Participant Flow|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115570|NCT00527735|P1|Participant Flow|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until progressive disease (PD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115571|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
1115572|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115602|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
1115573|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115574|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115575|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115576|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
1115577|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115578|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115579|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
1115750|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
1115580|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115581|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115582|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
1116937|NCT00524264|E2|Reported Event|Vehicle Solution|
1115584|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (concurrent). The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes every 3 weeks as part of induction. Participants could also receive additional maintenance ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
1115585|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
1115586|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115587|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115588|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
1115589|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115620|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
1115590|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115591|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
1115592|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115650|NCT00527618|B1|Baseline|Entire Study Population|This includes all 34 participants who were randomized. A subset of 28 participants were included in the analysis since only 28 participants contributed samples on both arms of the crossover study.
1115651|NCT00527618|P2|Participant Flow|Valacyclovir Followed by Acyclovir|Valacyclovir 1000 mg twice daily, followed by a two-week washout period, then acyclovir 400 mg twice daily
1115783|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
1115593|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115594|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115595|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115596|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
1115597|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115598|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115599|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
1115690|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
1127299|NCT00494221|E1|Reported Event|Cediranib 20 mg|Cediranib 20 mg
1115600|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115601|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115652|NCT00527618|P1|Participant Flow|Acyclovir Followed by Valacyclovir|Acyclovir 400 mg twice daily, followed by a two-week washout period, then valacyclovir 1000 mg twice daily
1115653|NCT00527618|O1|Outcome|Valacyclovir|Valacyclovir, 1000 mg orally twice daily
1115654|NCT00527618|O2|Outcome|Valacyclovir|Valacyclovir, 1000 mg orally twice daily (assigned to the valacyclovir arm in either the first or second intervention periods)
1115603|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115604|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115605|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
1115606|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115607|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115608|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
1115609|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115691|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
1115610|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115611|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
1115612|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115613|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115614|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
1115615|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115616|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115617|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
1115618|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115619|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115692|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
1115621|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115622|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115623|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
1115624|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115625|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115626|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
1115627|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115628|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115629|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
1115630|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115693|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
1115631|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115632|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
1115633|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115634|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115635|NCT00527735|E6|Reported Event|Placebo + Paclitaxel/Carboplatin SCLC|During induction, participants with SCLC received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
1115636|NCT00527735|E5|Reported Event|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) SCLC|During induction, participants with SCLC received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until progressive disease, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115637|NCT00527735|E4|Reported Event|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) SCLC|During induction, participants with small-cell lung cancer (SCLC) received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115638|NCT00527735|E3|Reported Event|Placebo + Paclitaxel/Carboplatin NSCLC|During induction, participants with NSCLC received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
1115639|NCT00527735|E2|Reported Event|Placebo/Ipilimumab+ Paclitaxel/Carboplatin (Sequential) NSCLC|During induction, participants with NSCLC received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115694|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
1115695|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
1115696|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
1115697|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
1115698|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
1115699|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
1127412|NCT00493805|E1|Reported Event|Non Interventional Arm HOMA IR <=2|
1115640|NCT00527735|E1|Reported Event|Ipilimubab+Paclitaxel/Carboplatin (Concurrent) NSCLC|During induction, participants with nonsmall-cell lung cancer (NSCLC) received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered intravenously (IV) over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
1115641|NCT00527722|B3|Baseline|Total|Total of all reporting groups
1115642|NCT00527722|B2|Baseline|No Pleural Plug|The standard lung biopsy without placement of the plug.
1115643|NCT00527722|B1|Baseline|Pleural Plug|Experimental lung plug after the lung biopsy.
1115644|NCT00527722|P2|Participant Flow|No Pleural Plug|The standard lung biopsy without placement of the plug.
1115645|NCT00527722|P1|Participant Flow|Pleural Plug|Experimental lung plug after the lung biopsy.
1115646|NCT00527722|O2|Outcome|No Pleural Plug|The standard lung biopsy without placement of the plug.
1115647|NCT00527722|O1|Outcome|Pleural Plug|Experimental lung plug after the lung biopsy.
1115648|NCT00527722|E2|Reported Event|No Pleural Plug|The standard lung biopsy without placement of the plug.
1115649|NCT00527722|E1|Reported Event|Pleural Plug|Experimental lung plug after the lung biopsy.
1115655|NCT00527618|O1|Outcome|Acyclovir|Acyclovir, 400 mg orally twice daily (assigned to the acyclovir arm in either the first or second intervention periods)
1115658|NCT00527618|O2|Outcome|Valacyclovir|Valacyclovir, 1000 mg orally twice daily (assigned to the valacyclovir arm in either the first or second intervention periods)
1115659|NCT00527618|O1|Outcome|Acyclovir|Acyclovir, 400 mg orally twice daily (assigned to the acyclovir arm in either the first or second intervention periods)
1115660|NCT00527618|O2|Outcome|Valacyclovir|Valacyclovir, 1000 mg orally twice daily (assigned to the valacyclovir arm in either the first or second intervention periods)
1115661|NCT00527618|O1|Outcome|Acyclovir|Acyclovir, 400 mg orally twice daily (assigned to the acyclovir arm in either the first or second intervention periods)
1115662|NCT00527618|E2|Reported Event|Valacyclovir|Valacyclovir, 1000 mg orally twice daily (assigned to the valacyclovir arm in either the first or second intervention periods)
1115663|NCT00527618|E1|Reported Event|Acyclovir|Acyclovir, 400 mg orally twice daily (assigned to the acyclovir arm in either the first or second intervention periods)
1115664|NCT00527605|B3|Baseline|Total|Total of all reporting groups
1115665|NCT00527605|B2|Baseline|Placebo|Matching oral placebo once a day for 6 months
1115666|NCT00527605|B1|Baseline|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
1115667|NCT00527605|P2|Participant Flow|Placebo|Matching oral placebo once a day for 6 months
1115668|NCT00527605|P1|Participant Flow|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
1115669|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
1115670|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
1115671|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
1115672|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
1115673|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
1115674|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
1115675|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
1115676|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
1115677|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
1115678|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
1115679|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
1115680|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
1115681|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
1115682|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
1115683|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
1115684|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
1115685|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
1115686|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
1115687|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
1115688|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
1115689|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
1115700|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
1115701|NCT00527605|E2|Reported Event|Placebo|Matching oral placebo once a day for 6 months
1115702|NCT00527605|E1|Reported Event|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
1115703|NCT00527592|B1|Baseline|Travoprost/Latanoprost|Travoprost assigned to one eye, with latanoprost assigned to the fellow eye for intra-individual control.
1115704|NCT00527592|P1|Participant Flow|Travoprost/Latanoprost|Travoprost assigned to one eye, with latanoprost assigned to the fellow eye for intra-individual control.
1115705|NCT00527592|O2|Outcome|Latanoprost|One drop in the study eye, single dose
1115706|NCT00527592|O1|Outcome|Travoprost|One drop in the study eye, single dose
1115707|NCT00527592|E2|Reported Event|Latanoprost|One drop in the study eye, single dose
1115708|NCT00527592|E1|Reported Event|Travoprost|One drop in the study eye, single dose
1115709|NCT00527566|B1|Baseline|Mepolizumab|Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.
1115710|NCT00527566|P1|Participant Flow|Mepolizumab|Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.
1115711|NCT00527566|O2|Outcome|Non-treatment Phase|The non-treatment phase consists of the wash-out phase and the safety monitoring phase.
1115712|NCT00527566|O1|Outcome|Mepolizumab (Treatment Phase)|Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.
1115713|NCT00527566|O1|Outcome|Mepolizumab|Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.
1115714|NCT00527566|O1|Outcome|Mepolizumab|Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.
1115715|NCT00527566|O1|Outcome|Mepolizumab|Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.
1115716|NCT00527566|O1|Outcome|Mepolizumab|Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.
1115717|NCT00527566|E1|Reported Event|Mepolizumab|Intravenously infused 750 mg of mepolizumab 1x every 4 weeks for 16 weeks.
1115718|NCT00527514|B1|Baseline|Amlodipine and Olmesartan, if Necessary|Week 1-3 all participants: Amlodipine 5mg; Week 4-6 Amlodipine 5 mg/olmesartan 20 mg if mean SBP >= 120/80 mm Hg; Week 7-9 Amlodipine 5 mg/ olmesartan 40 mg if mean SBP >= 120/80 mm Hg; Week 10-12 Amlodipine 10 mg/olmesartan 40 mg if mean SBP >= 120/80 mm Hg
1115719|NCT00527514|P1|Participant Flow|Amlodipine and Olmesartan, if Necessary|All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.
1115720|NCT00527514|O1|Outcome|Group 4 - Aml 10 mg + Olm 40 mg|
1115721|NCT00527514|O1|Outcome|Group 3 - Aml 5 mg + Olm 40 mg|Participants from Group 2 who did not meet the blood pressure goal after 3 weeks were titrated to Aml 5 mg + olmesartan 40mg.
1115722|NCT00527514|O1|Outcome|Group 2 - Aml 5 mg + Olmesartan 20 mg|Participants from Group 1 who did not meet the blood pressure goal after 3 weeks were titrated to Aml 5 mg + olmesartan 20 mg.
1115723|NCT00527514|O1|Outcome|Group 1 Amlodipine 5 mg|All participants started the Active Treatment period with 5 mg of amlodipine for 3 weeks.
1115724|NCT00527514|O1|Outcome|Overall Active Treatment Period|
1115725|NCT00527514|O1|Outcome|Overall Active Treatment Period|
1115726|NCT00527514|E4|Reported Event|Amlodipine 10 mg and Olmesartan 40 mg|All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.
1115727|NCT00527514|E3|Reported Event|Amlodipine 5mg and Olmesartan 40 mg|All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.
1115728|NCT00527514|E2|Reported Event|Amlodipine 5mg and Olmesartan 20 mg|All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.
1115729|NCT00527514|E1|Reported Event|Amlodipine 5 mg|All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.
1115730|NCT00527488|B5|Baseline|Total|Total of all reporting groups
1115731|NCT00527488|B4|Baseline|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
1115732|NCT00527488|B3|Baseline|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
1115733|NCT00527488|B2|Baseline|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
1115734|NCT00527488|B1|Baseline|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
1115735|NCT00527488|P4|Participant Flow|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
1115736|NCT00527488|P3|Participant Flow|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
1115737|NCT00527488|P2|Participant Flow|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
1115738|NCT00527488|P1|Participant Flow|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
1115739|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
1115740|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
1115741|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
1115742|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
1115743|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
1115744|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
1115745|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
1115746|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
1115747|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
1115748|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
1115749|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
1115751|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
1115752|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
1115753|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
1115754|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
1115755|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
1115756|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
1115757|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
1115758|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
1115759|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
1115760|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
1115761|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
1115762|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
1115763|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
1115764|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
1115765|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
1115766|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
1115767|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
1115768|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
1115769|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
1115770|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
1115771|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
1115772|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
1115773|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
1115774|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
1115775|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
1115776|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
1115777|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
1115778|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
1115779|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
1115780|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
1115781|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
1115785|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
1115786|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
1115787|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
1115788|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
1115789|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
1115790|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
1115791|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
1115792|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
1115793|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
1115794|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
1115795|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
1115796|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
1115797|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
1115798|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
1115799|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
1115800|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
1115801|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
1115802|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
1115803|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
1115804|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
1115805|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
1115806|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
1115807|NCT00527488|E4|Reported Event|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
1115808|NCT00527488|E3|Reported Event|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
1115809|NCT00527488|E2|Reported Event|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
1115810|NCT00527488|E1|Reported Event|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
1115811|NCT00527475|B3|Baseline|Total|Total of all reporting groups
1115812|NCT00527475|B2|Baseline|Group II|Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.
1115813|NCT00527475|B1|Baseline|Group I|Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.
1115839|NCT00527397|O1|Outcome|Type 1 Diabetes Mellitus|subjects with type 1 diabetes mellitus
1115840|NCT00527397|O3|Outcome|Type 2 Diabetes Mellitus Not Using Insulin|subjects with type 2 diabetes mellitus who had not yet treated by Insulin
1115814|NCT00527475|P2|Participant Flow|Reduced Fluence PDT & Ranibizumab|Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.
1115815|NCT00527475|P1|Participant Flow|Ranibizumab|Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.
1115816|NCT00527475|O2|Outcome|Group II|Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.
1115817|NCT00527475|O1|Outcome|Group I|Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.
1115818|NCT00527475|E2|Reported Event|Group II|Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.
1115819|NCT00527475|E1|Reported Event|Group I|Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.
1115820|NCT00527423|B1|Baseline|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg|"The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or as needed dosing). If, at any point during the study, in the investigator's opinion, a participant required dosing or evaluation more frequently than every 8 weeks, monthly visits and dosing were permitted. The maximum frequency of injection into the study eye was every 4 weeks."
1115821|NCT00527423|P1|Participant Flow|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg|"The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or as needed dosing). If, at any point during the study, in the investigator's opinion, a participant required dosing or evaluation more frequently than every 8 weeks, monthly visits and dosing were permitted. The maximum frequency of injection into the study eye was every 4 weeks."
1115822|NCT00527423|O1|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg|The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or
1115865|NCT00527319|P1|Participant Flow|Group A, Control Group|Supportive care only
1115866|NCT00527319|O3|Outcome|Group C, High Dose VT-122|VT-122 (dose of etodolac: 800 mg/day) + supportive care
1115867|NCT00527319|O2|Outcome|Group B, Low Dose VT-122|VT-122 (dose of etodolac: 400 mg/day) + supportive care
1115823|NCT00527423|O1|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg|The study consisted of a treatment period from day 1 to week 152 (end of treatment), and a 4-week follow-up visit at week 156 (end of study). Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or
1115824|NCT00527423|O1|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg|"The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or as needed dosing). If, at any point during the study, in the investigator's opinion, a participant required dosing or evaluation more frequently than every 8 weeks, monthly visits and dosing were permitted. The maximum frequency of injection into the study eye was every 4 weeks."
1115825|NCT00527423|E1|Reported Event|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg|"The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or as needed dosing). If, at any point during the study, in the investigator's opinion, a participant required dosing or evaluation more frequently than every 8 weeks, monthly visits and dosing were permitted. The maximum frequency of injection into the study eye was every 4 weeks."
1115826|NCT00527397|B1|Baseline|All Subjects With Type 1 or Type 2 Diabetes Mellitus|All subjects with type 1 or type 2 diabetes mellitus treated with inhaled insulin in this study. This study was open-label, uncontrolled study and at all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times.
1115827|NCT00527397|P1|Participant Flow|All Subjects With Type 1 or Type 2 Diabetes Mellitus|All subjects with type 1 or type 2 diabetes mellitus treated with inhaled insulin in this study. This study was open-label, uncontrolled study and at all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times.
1115828|NCT00527397|O3|Outcome|Type 2 Diabetes Mellitus Not Using Insulin|subjects with type 2 diabetes mellitus who had not yet treated by Insulin
1115829|NCT00527397|O2|Outcome|Type 2 Diabetes Mellitus Using Insulin|subjects with type 2 diabetes mellitus who had already treated by Insulin
1115830|NCT00527397|O1|Outcome|Type 1 Diabetes Mellitus|subjects with type 1 diabetes mellitus
1115831|NCT00527397|O3|Outcome|Type 2 Diabetes Mellitus Not Using Insulin|subjects with type 2 diabetes mellitus who had not yet treated by Insulin
1115832|NCT00527397|O2|Outcome|Type 2 Diabetes Mellitus Using Insulin|subjects with type 2 diabetes mellitus who had already treated by Insulin
1115833|NCT00527397|O1|Outcome|Type 1 Diabetes Mellitus|subjects with type 1 diabetes mellitus
1115834|NCT00527397|O1|Outcome|All Subjects|subjects treated with inhaled insulin
1115835|NCT00527397|O1|Outcome|All Subjects|subjects treated with inhaled insulin
1115836|NCT00527397|O1|Outcome|All Subjects|subjects treated with inhaled insulin
1115837|NCT00527397|O3|Outcome|Type 2 Diabetes Mellitus Not Using Insulin|subjects with type 2 diabetes mellitus who had not yet treated by Insulin
1115838|NCT00527397|O2|Outcome|Type 2 Diabetes Mellitus Using Insulin|subjects with type 2 diabetes mellitus who had already treated by Insulin
1115841|NCT00527397|O2|Outcome|Type 2 Diabetes Mellitus Using Insulin|subjects with type 2 diabetes mellitus who had already treated by Insulin
1115842|NCT00527397|O1|Outcome|Type 1 Diabetes Mellitus|subjects with type 1 diabetes mellitus
1115843|NCT00527397|O3|Outcome|Type 2 Diabetes Mellitus Not Using Insulin|subjects with type 2 diabetes mellitus who had not yet treated by Insulin
1115844|NCT00527397|O2|Outcome|Type 2 Diabetes Mellitus Using Insulin|subjects with type 2 diabetes mellitus who had already treated by Insulin
1115845|NCT00527397|O1|Outcome|Type 1 Diabetes Mellitus|subjects with type 1 diabetes mellitus
1115846|NCT00527397|O3|Outcome|Type 2 Diabetes Mellitus Not Using Insulin|subjects with type 2 diabetes mellitus who had not yet treated by Insulin
1115847|NCT00527397|O2|Outcome|Type 2 Diabetes Mellitus Using Insulin|subjects with type 2 diabetes mellitus who had already treated by Insulin
1115848|NCT00527397|O1|Outcome|Type 1 Diabetes Mellitus|subjects with type 1 diabetes mellitus
1115849|NCT00527397|E1|Reported Event|All Subjects With Type 1 or Type 2 Diabetes Mellitus|all subjects with type 1 or type 2 diabetes mellitus treated with inhaled insulin in this study. This study was open-label, uncontrolled study and at all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times.
1115850|NCT00527332|B3|Baseline|Total|Total of all reporting groups
1115851|NCT00527332|B2|Baseline|General Anesthesia|General anesthesia
1115852|NCT00527332|B1|Baseline|Spinal Anesthesia|Spinal anesthesia combined with intrathecal morphine
1115853|NCT00527332|P2|Participant Flow|General Anesthesia|General anesthesia
1115854|NCT00527332|P1|Participant Flow|Spinal Anesthesia|Spinal anesthesia combined with intrathecal morphine
1115855|NCT00527332|O2|Outcome|General Anesthesia|General anesthesia. General anesthesia induced with propofol, fentanyl and rocuronium, and maintained with propofol and oxygen in air. Rocuronium and fentanyl repeated when needed.
1115856|NCT00527332|O1|Outcome|Spinal Anesthesia|Spinal anesthesia combined with intrathecal morphine. Spinal anesthesia applied in intervertebral space L3/L4 or L2/L3 with hyperbaric bupivacaine 20 mg and morphine 0.2 mg intrathecally. Sedation with propofol.
1115857|NCT00527332|E2|Reported Event|General Anesthesia|General anesthesia
1115858|NCT00527332|E1|Reported Event|Spinal Anesthesia|Spinal anesthesia combined with intrathecal morphine
1115859|NCT00527319|B4|Baseline|Total|Total of all reporting groups
1115860|NCT00527319|B3|Baseline|Group C, High Dose VT-122|VT-122 (dose of etodolac: 800 mg/day) + supportive care
1115861|NCT00527319|B2|Baseline|Group B, Low Dose VT-122|VT-122 (dose of etodolac: 400 mg/day) + supportive care
1115862|NCT00527319|B1|Baseline|Group A, Control Group|Supportive care only
1115863|NCT00527319|P3|Participant Flow|Group C, High Dose VT-122|VT-122 high dose Supportive care
1115864|NCT00527319|P2|Participant Flow|Group B, Low Dose VT-122|VT-122 low dose Supportive care
1115869|NCT00527319|O3|Outcome|Group C, High Dose VT-122|VT-122 (dose of etodolac: 800 mg/day) + supportive care
1115870|NCT00527319|O2|Outcome|Group B, Low Dose VT-122|VT-122 (dose of etodolac: 400 mg/day) + supportive care
1115871|NCT00527319|O1|Outcome|Group A, Control Group|Supportive care only
1115872|NCT00527319|E3|Reported Event|Group C, High Dose VT-122|VT-122 (dose of etodolac: 800 mg/day) + supportive care
1115873|NCT00527319|E2|Reported Event|Group B, Low Dose VT-122|VT-122 (dose of etodolac: 400 mg/day) + supportive care
1115874|NCT00527319|E1|Reported Event|Group A, Control Group|Supportive care only
1115875|NCT00526890|B1|Baseline|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
1115876|NCT00526890|P1|Participant Flow|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
1115877|NCT00526890|O1|Outcome|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
1115878|NCT00526890|O1|Outcome|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
1115879|NCT00526890|O1|Outcome|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
1115880|NCT00526890|O1|Outcome|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
1115881|NCT00526890|O1|Outcome|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
1115882|NCT00526890|O1|Outcome|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
1115883|NCT00526890|E1|Reported Event|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
1115884|NCT00526799|B3|Baseline|Total|Total of all reporting groups
1115885|NCT00526799|B2|Baseline|Phase II|Topotecan 3.5 mg/m^2 + Sorafenib 400 mg po daily.
1115886|NCT00526799|B1|Baseline|Phase I|"Topotecan 3.5 mg/m^2 + Sorafenib assigned dose level:~Sorafenib Dose level -1=200 mg po daily Sorafenib Dose level 1=400 mg po daily Sorafenib Dose level 2=400 mag po bid"
1115887|NCT00526799|P2|Participant Flow|Phase II|Topotecan 3.5 mg/m^2 + Sorafenib 400 mg po daily.
1115888|NCT00526799|P1|Participant Flow|Phase I|"Topotecan 3.5 mg/m^2 + Sorafenib assigned dose level:~Sorafenib Dose level -1=200 mg po daily Sorafenib Dose level 1=400 mg po daily Sorafenib Dose level 2=400 mag po bid"
1115889|NCT00526799|O1|Outcome|Phase II|Topotecan 3.5 mg/m^2 + Sorafenib 400 mg po daily.
1115890|NCT00526799|O1|Outcome|Phase II|Topotecan 3.5 mg/m^2 + Sorafenib 400 mg po daily.
1115891|NCT00526799|O1|Outcome|Phase I & II|"Topotecan 3.5 mg/m^2 + Sorafenib 400 mg po daily during phase II.~During phase I:~Topotecan 3.5 mg/m^2 + Sorafenib assigned dose level:~Sorafenib Dose level -1=200 mg po daily Sorafenib Dose level 1=400 mg po daily Sorafenib Dose level 2=400 mag po bid"
1115892|NCT00526799|O1|Outcome|Phase II|Topotecan 3.5 mg/m^2 + Sorafenib 400 mg po daily.
1115893|NCT00526799|O1|Outcome|Phase I Participants|Phase I Participants evaluable for MTD
1115894|NCT00526799|E1|Reported Event|Phase I/Phase II|All Phase I/Phase II participants
1115931|NCT00526630|O3|Outcome|Baseline|All participants with baseline data
1115895|NCT00526669|B1|Baseline|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
1115896|NCT00526669|P2|Participant Flow|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
1115897|NCT00526669|P1|Participant Flow|Lapatinib|Lapatinib 250 milligram (mg) tablets administered at a dose of 1250 mg once daily (OD) for 7 days
1115898|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
1115899|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
1115900|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
1115901|NCT00526669|O1|Outcome|Overall Study Arm|
1115902|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
1115903|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
1116938|NCT00524264|E1|Reported Event|Ketorolac Solution|
1115904|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
1115905|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
1115906|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
1115907|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
1115908|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
1115909|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
1115910|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
1115932|NCT00526630|O2|Outcome|2. Placebo|Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
1115911|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
1115912|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
1115913|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
1115914|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
1115915|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
1115916|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
1115917|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
1115955|NCT00526474|B2|Baseline|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115918|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
1115919|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
1115920|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
1115921|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
1115922|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
1115923|NCT00526669|O1|Outcome|Lapatinib|Lapatinib 250 milligram (mg) tablets administered at a dose of 1250 mg once daily (OD) for 7 days
1115924|NCT00526669|E1|Reported Event|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
1115925|NCT00526630|B1|Baseline|All Participants|Participants were randomized to receive both MPD and placebo.
1115926|NCT00526630|P2|Participant Flow|Placebo Then MPD|First group treated with placebo then MPD
1115927|NCT00526630|P1|Participant Flow|MPD Then Placebo|First group treated with MPD then placebo
1115928|NCT00526630|O3|Outcome|Baseline|All participants with baseline data
1115929|NCT00526630|O2|Outcome|2. Placebo|Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
1115930|NCT00526630|O1|Outcome|1. MPD|Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
1115933|NCT00526630|O1|Outcome|1. MPD|Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
1115934|NCT00526630|O3|Outcome|Baseline|All participants with baseline data
1115935|NCT00526630|O2|Outcome|2. Placebo|Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
1115936|NCT00526630|O1|Outcome|1. MPD|Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
1115937|NCT00526630|O3|Outcome|Baseline|All participants with baseline data
1115938|NCT00526630|O2|Outcome|2. Placebo|Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
1115939|NCT00526630|O1|Outcome|1. MPD|Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
1115940|NCT00526630|O3|Outcome|Baseline|All participants with baseline data
1115941|NCT00526630|O2|Outcome|2. Placebo|Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
1115942|NCT00526630|O1|Outcome|1. MPD|Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
1115943|NCT00526630|O3|Outcome|Baseline|All participants with baseline data
1115944|NCT00526630|O2|Outcome|2. Placebo|Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
1115945|NCT00526630|O1|Outcome|1. MPD|Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
1115946|NCT00526630|O3|Outcome|Baseline|All participants with baseline data
1115947|NCT00526630|O2|Outcome|2. Placebo|Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
1115948|NCT00526630|O1|Outcome|1. MPD|Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
1115949|NCT00526630|O3|Outcome|Baseline|Baseline gait composite scores
1115950|NCT00526630|O2|Outcome|2. Placebo|Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
1115951|NCT00526630|O1|Outcome|1. MPD|Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
1115952|NCT00526630|E2|Reported Event|2. Placebo|"Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.~Placebo: Participants will be given placebo instead of active MPD."
1115953|NCT00526630|E1|Reported Event|1. MPD|"Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.~Methylphenidate (MPD): Participants will be given 1 mg/kg of MPD divided in three doses (at 8 am, 12 noon, and 4 pm). A four-week titration period will be used, using 0.25-mg/kg increments per week until achieving the weight-adjusted target dosage, which may range from five to eight 10-mg tablets per day. The maximum daily dose will be 80 mg/day."
1115954|NCT00526474|B3|Baseline|Total|Total of all reporting groups
1116063|NCT00526123|O1|Outcome|Symmetric Tip|symmetric tip hemodialysis catheter
1116064|NCT00526123|O2|Outcome|Split-tip|split-tip hemodialysis catheter
1115956|NCT00526474|B1|Baseline|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115957|NCT00526474|P2|Participant Flow|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115958|NCT00526474|P1|Participant Flow|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115959|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115960|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115961|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115962|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115963|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115964|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115965|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115966|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115967|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115968|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115969|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115970|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115971|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115972|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115973|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115974|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115975|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115976|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115977|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115978|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115979|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115980|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115981|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115982|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115983|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115984|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115985|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1116065|NCT00526123|O1|Outcome|Symmetric Tip|symmetric tip hemodialysis catheter
1116066|NCT00526123|O2|Outcome|Split-tip|split-tip hemodialysis catheter
1115986|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115987|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115988|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115989|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115990|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115991|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115992|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115993|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115994|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115995|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115996|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115997|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115998|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1115999|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1116000|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1116001|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1116032|NCT00526292|E1|Reported Event|HLA Haploidentical Natural Killer Cell Infusion|HLA Haploidentical Natural Killer Cell Infusion for Treatment of Relapsed or Persistent Leukemia
1116002|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1116003|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1116004|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1116005|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1116006|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1116007|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1116008|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1116009|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1116010|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1116011|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1116012|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1116013|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1116014|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1116015|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1116016|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1116017|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1116018|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1116019|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1116020|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1116021|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1116022|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1116023|NCT00526474|E2|Reported Event|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1116024|NCT00526474|E1|Reported Event|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
1116025|NCT00526331|B1|Baseline|Overall Study|Study Group: FloTrac Sensor + Vigileo Monitor used to decide how much fluid to give during surgery; and Control Group: FloTrac Sensor + Vigileo Monitor only used for data collection during surgery while Standard of Care used to decide fluid amount.
1116026|NCT00526331|P1|Participant Flow|Overall Study|Study Group: FloTrac Sensor + Vigileo Monitor used to decide how much fluid to give during surgery; and Control Group: FloTrac Sensor + Vigileo Monitor only used for data collection during surgery while Standard of Care used to decide fluid amount.
1116027|NCT00526331|O1|Outcome|Overall Study|Study Group: FloTrac Sensor + Vigileo Monitor used to decide how much fluid to give during surgery; and Control Group: FloTrac Sensor + Vigileo Monitor only used for data collection during surgery while Standard of Care used to decide fluid amount.
1116028|NCT00526331|E1|Reported Event|Overall Study|Study Group: FloTrac Sensor + Vigileo Monitor used to decide how much fluid to give during surgery; and Control Group: FloTrac Sensor + Vigileo Monitor only used for data collection during surgery while Standard of Care used to decide fluid amount.
1116029|NCT00526292|B1|Baseline|HLA Haploidentical Natural Killer Cell Infusion|HLA Haploidentical Natural Killer Cell Infusion for Treatment of Relapsed or Persistent Leukemia
1116030|NCT00526292|P1|Participant Flow|HLA Haploidentical Natural Killer Cell Infusion|HLA Haploidentical Natural Killer Cell Infusion for Treatment of Relapsed or Persistent Leukemia
1116031|NCT00526292|O1|Outcome|HLA Haploidentical Natural Killer Cell Infusion|HLA Haploidentical Natural Killer Cell Infusion for Treatment of Relapsed or Persistent Leukemia
1116033|NCT00526227|B1|Baseline|1|
1116034|NCT00526227|P1|Participant Flow|1|
1116038|NCT00526188|B1|Baseline|Gadoxetic Acid Disodium (Primovist, BAY86-4873)|Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
1116039|NCT00526188|P1|Participant Flow|Gadoxetic Acid Disodium (Primovist, BAY86-4873)|Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
1116040|NCT00526188|O1|Outcome|Gadoxetic Acid Disodium (Primovist, BAY86-4873)|Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
1116041|NCT00526188|O1|Outcome|Gadoxetic Acid Disodium (Primovist, BAY86-4873)|Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
1116042|NCT00526188|O1|Outcome|Gadoxetic Acid Disodium (Primovist, BAY86-4873)|Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
1116043|NCT00526188|E1|Reported Event|Gadoxetic Acid Disodium (Primovist, BAY86-4873)|Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
1116044|NCT00526162|B1|Baseline|1|
1116045|NCT00526162|P1|Participant Flow|1|
1116046|NCT00526162|O1|Outcome|1|
1116047|NCT00526162|O1|Outcome|1|
1116048|NCT00526162|O1|Outcome|1|
1116049|NCT00526123|B3|Baseline|Total|Total of all reporting groups
1116050|NCT00526123|B2|Baseline|Split-tip|split-tip hemodialysis catheter
1116051|NCT00526123|B1|Baseline|Symmetric Tip|symmetric tip hemodialysis catheter
1116052|NCT00526123|P2|Participant Flow|Split-tip|split-tip hemodialysis catheter
1116053|NCT00526123|P1|Participant Flow|Symmetric Tip|symmetric tip hemodialysis catheter
1116054|NCT00526123|O2|Outcome|Split-tip|split-tip hemodialysis catheter
1116055|NCT00526123|O1|Outcome|Symmetric Tip|symmetric tip hemodialysis catheter
1116056|NCT00526123|O2|Outcome|Split-tip|split-tip hemodialysis catheter
1116057|NCT00526123|O1|Outcome|Symmetric Tip|symmetric tip hemodialysis catheter
1116058|NCT00526123|O2|Outcome|Split-tip|split-tip hemodialysis catheter
1116059|NCT00526123|O1|Outcome|Symmetric Tip|symmetric tip hemodialysis catheter
1116060|NCT00526123|O2|Outcome|Split-tip|split-tip hemodialysis catheter
1116061|NCT00526123|O1|Outcome|Symmetric Tip|symmetric tip hemodialysis catheter
1116062|NCT00526123|O2|Outcome|Split-tip|split-tip hemodialysis catheter
1116067|NCT00526123|O1|Outcome|Symmetric Tip|symmetric tip hemodialysis catheter
1116068|NCT00526123|O2|Outcome|Split-tip|split-tip hemodialysis catheter
1116069|NCT00526123|O1|Outcome|Symmetric Tip|symmetric tip hemodialysis catheter
1116070|NCT00526123|E2|Reported Event|Split-tip|split-tip hemodialysis catheter
1116071|NCT00526123|E1|Reported Event|Symmetric Tip|symmetric tip hemodialysis catheter
1116072|NCT00526110|B3|Baseline|Total|Total of all reporting groups
1116073|NCT00526110|B2|Baseline|Phase II|Phase II: Docetaxel 50 mg/m^2 IV over 60 minutes. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
1116074|NCT00526110|B1|Baseline|Phase I|Phase I: Starting dose of 20mg/m^2 IV Docetaxel over 60 minutes. Dose escalation of Docetaxel in 2.5 mg/m^2 increments until the maximum tolerated dose is determined. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
1116075|NCT00526110|P2|Participant Flow|Phase II: Docetaxel MTD 50 mg/m^2|Phase II: Docetaxel 50 mg/m^2 IV over 60 minutes. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
1116076|NCT00526110|P1|Participant Flow|Phase I: Dose Escalation|Phase I: Starting dose of 20mg/m^2 IV Docetaxel over 60 minutes. Dose escalation of Docetaxel in 2.5 mg/m^2 increments until the maximum tolerated dose is determined. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
1116077|NCT00526110|O1|Outcome|Phase II|Phase II: Docetaxel 50 mg/m^2 IV over 60 minutes. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
1116078|NCT00526110|O1|Outcome|Phase II|Phase II: Docetaxel 50 mg/m^2 IV over 60 minutes. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
1116079|NCT00526110|O1|Outcome|Phase I|Phase I: Starting dose of 20mg/m^2 IV Docetaxel over 60 minutes. Dose escalation of Docetaxel in 2.5 mg/m^2 increments until the maximum tolerated dose is determined. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
1116080|NCT00526110|E2|Reported Event|Phase II|Phase II: Docetaxel 50 mg/m^2 IV over 60 minutes. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
1116148|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116149|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116081|NCT00526110|E1|Reported Event|Phase I|Phase I: Starting dose of 20mg/m^2 IV Docetaxel over 60 minutes. Dose escalation of Docetaxel in 2.5 mg/m^2 increments until the maximum tolerated dose is determined. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
1116082|NCT00526097|B3|Baseline|Total|Total of all reporting groups
1116083|NCT00526097|B2|Baseline|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116084|NCT00526097|B1|Baseline|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116085|NCT00526097|P2|Participant Flow|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116086|NCT00526097|P1|Participant Flow|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116087|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116088|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116089|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116090|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116091|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116092|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116093|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116094|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116095|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116096|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116097|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116098|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116099|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116100|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116101|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116102|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116103|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116104|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116105|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116106|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116107|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116108|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116109|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116110|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116111|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116112|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116113|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116114|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116115|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116116|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116117|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116118|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116119|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116120|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116121|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116122|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116123|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116124|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116125|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116126|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116127|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116128|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116129|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116130|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116131|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116132|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116133|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116134|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116135|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116136|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116137|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116138|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116139|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116140|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116141|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116142|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116143|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116144|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116145|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116146|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116147|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116150|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116151|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116152|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116153|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116154|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116155|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116156|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116157|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116158|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116159|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116160|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116161|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116162|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116163|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116164|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116165|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116166|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116167|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116168|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116169|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116170|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116171|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116172|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116173|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116174|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116175|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116176|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116177|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116178|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116179|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116180|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116181|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116182|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116183|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116184|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116185|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116186|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116187|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116188|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116189|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116190|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116191|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116192|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116193|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116194|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116195|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116196|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116197|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116198|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116199|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116200|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116201|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116202|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116203|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116204|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116205|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116206|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116207|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116208|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116209|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116210|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116211|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116212|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116213|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116214|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116215|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116216|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116217|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116218|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116219|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116220|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116221|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116222|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116223|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116224|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116225|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116226|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116227|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116228|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116229|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116230|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116231|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116232|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116233|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116234|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116235|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116236|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116237|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116238|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116239|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116240|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116241|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116242|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116243|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116244|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116245|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116246|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116247|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116248|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116249|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116250|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116251|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116252|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116253|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116254|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116255|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116256|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116257|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116258|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116259|NCT00526097|E2|Reported Event|Bisacodyl|Two bisacodyl 5 mg tablets once daily
1116260|NCT00526097|E1|Reported Event|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
1116261|NCT00526058|B3|Baseline|Total|Total of all reporting groups
1116262|NCT00526058|B2|Baseline|Futura|Randomized first to the approved Plasmat® Futura apheresis system then Plasmat® Secura apheresis system.
1116263|NCT00526058|B1|Baseline|Secura|Randomized first to the approved Plasmat® Secura apheresis system then Plasmat® Futura apheresis system.
1116264|NCT00526058|P2|Participant Flow|Futura|Randomized first to the approved Plasmat® Futura apheresis system then Plasmat® Secura apheresis system.
1116265|NCT00526058|P1|Participant Flow|Secura|Randomized first to the approved Plasmat® Secura apheresis system then Plasmat® Futura apheresis system.
1116266|NCT00526058|O2|Outcome|Futura|Data for all 18 subjects; regardless of treatment sequence (Secura-Futura or Futura-Secura)
1116267|NCT00526058|O1|Outcome|Secura|Data for all 18 subjects; regardless of treatment sequence (Secura-Futura or Futura-Secura)
1116268|NCT00526058|E2|Reported Event|Futura|Randomized first to the approved Plasmat® Futura apheresis system then Plasmat® Secura apheresis system.
1116269|NCT00526058|E1|Reported Event|Secura|Randomized first to the approved Plasmat® Secura apheresis system then Plasmat® Futura apheresis system.
1116270|NCT00525915|B3|Baseline|Total|Total of all reporting groups
1116271|NCT00525915|B2|Baseline|Arm B: Pre-Op Chemo + Chemo With Radiation Treatment|Pre-Operative Chemo 5-FU 2.2 mg/m^2 IV continuous infusion over 48 hours start on day 1 and 15, and Oxaliplatin 100 mg/m^2 IV over 2 hours on day 1 and 15; followed by Surgery + Chemo with Radiation Therapy (same as Arm A)
1116272|NCT00525915|B1|Baseline|Arm A: Chemo With Radiation Treatment|For 5 weeks, Chemotherapy (Chemo) of 5-Fluorouracil (5-FU) 250 mg/m^2 intravenous (IV) over 24 hours for 5 days weekly with Oxaliplatin 40 mg/m^2 IV daily over 2 hours, and Radiation treatment every weekday; then surgery.
1116273|NCT00525915|P2|Participant Flow|Arm B: Pre-Op Chemo + Chemo With Radiation Treatment|Pre-Operative Chemo 5-FU 2.2 mg/m^2 IV continuous infusion over 48 hours start on day 1 and 15, and Oxaliplatin 100 mg/m^2 IV over 2 hours on day 1 and 15; followed by Surgery + Chemo with Radiation Therapy (same as Arm A)
1116274|NCT00525915|P1|Participant Flow|Arm A: Chemo With Radiation Treatment|For 5 weeks, Chemotherapy (Chemo) of 5-Fluorouracil (5-FU) 250 mg/m^2 intravenous (IV) over 24 hours for 5 days weekly with Oxaliplatin 40 mg/m^2 IV daily over 2 hours, and Radiation treatment every weekday; then surgery.
1116275|NCT00525915|O2|Outcome|Arm B: Pre-Op Chemo + Chemo With Radiation Treatment|Pre-Operative Chemo 5-FU 2.2 mg/m^2 IV continuous infusion over 48 hours start on day 1 and 15, and Oxaliplatin 100 mg/m^2 IV on day 1 and 15; followed by Surgery + Chemo with Radiation Therapy (same as Arm A)
1116373|NCT00525798|O2|Outcome|Placebo|1 tablet of placebo daily
1116276|NCT00525915|O1|Outcome|Arm A: Chemo With Radiation Treatment|For 5 weeks, Chemotherapy (Chemo) of 5-Fluorouracil (5-FU) 250 mg/m^2 intravenous (IV) over 24 hours for 5 days weekly with Oxaliplatin 40 mg/m^2 IV daily over 2 hours, and Radiation treatment every weekday; then surgery.
1116277|NCT00525915|E2|Reported Event|Arm B: Pre-Op Chemo + Chemo With Radiation Treatment|Pre-Operative Chemo 5-FU 2.2 mg/m^2 IV continuous infusion over 48 hours start on day 1 and 15, and Oxaliplatin 100 mg/m^2 IV over 2 hours on day 1 and 15; followed by Surgery + Chemo with Radiation Therapy (same as Arm A)
1116278|NCT00525915|E1|Reported Event|Arm A: Chemo With Radiation Treatment|For 5 weeks, Chemotherapy (Chemo) of 5-Fluorouracil (5-FU) 250 mg/m^2 intravenous (IV) over 24 hours for 5 days weekly with Oxaliplatin 40 mg/m^2 IV daily over 2 hours, and Radiation treatment every weekday; then surgery.
1116279|NCT00525902|B1|Baseline|Adalimumab|
1116280|NCT00525902|P1|Participant Flow|Adalimumab|
1116281|NCT00525902|O1|Outcome|Adalimumab|
1116282|NCT00525902|O1|Outcome|Adalimumab|
1116283|NCT00525902|E1|Reported Event|Adalimumab|
1116284|NCT00525876|B3|Baseline|Total|Total of all reporting groups
1116285|NCT00525876|B2|Baseline|Allo MUD & MM|Allo MUD & MM = Allogeneic Stem Cell Transplantation, Matched unrelated donor or mismatched sibling donor transplantations: Cyclophosphamide 1000 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation. Alemtuzumab 15 mg per day given intravenously days 1 through 3 after transplantation.
1116286|NCT00525876|B1|Baseline|Matched Sibling Transplant|Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen: Cyclophosphamide 750 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation.
1116287|NCT00525876|P2|Participant Flow|Allo MUD & MM|Allo MUD & MM = Allogeneic Stem Cell Transplantation, Matched unrelated donor or mismatched sibling donor transplantations: Cyclophosphamide 1000 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation. Alemtuzumab 15 mg per day given intravenously days 1 through 3 after transplantation.
1116288|NCT00525876|P1|Participant Flow|Matched Sibling Transplant|Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen: Cyclophosphamide 750 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation.
1116337|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
1116338|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
1116339|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
1116477|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116289|NCT00525876|O2|Outcome|Allo MUD & MM|Allo MUD & MM = Allogeneic Stem Cell Transplantation, Matched unrelated donor or mismatched sibling donor transplantations: Cyclophosphamide 1000 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation. Alemtuzumab 15 mg per day given intravenously days 1 through 3 after transplantation.
1116290|NCT00525876|O1|Outcome|Matched Sibling Transplant|Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen: Cyclophosphamide 750 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation.
1116291|NCT00525876|E2|Reported Event|Allo MUD & MM|Allo MUD & MM = Allogeneic Stem Cell Transplantation, Matched unrelated donor or mismatched sibling donor transplantations: Cyclophosphamide 1000 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation. Alemtuzumab 15 mg per day given intravenously days 1 through 3 after transplantation.
1116292|NCT00525876|E1|Reported Event|Matched Sibling Transplant|Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen: Cyclophosphamide 750 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation.
1116293|NCT00525837|B1|Baseline|Varenicline|
1116294|NCT00525837|P1|Participant Flow|Varenicline|
1116295|NCT00525837|O1|Outcome|Varenicline|
1116296|NCT00525837|E1|Reported Event|Varenicline|
1116297|NCT00525824|B5|Baseline|Total|Total of all reporting groups
1116298|NCT00525824|B4|Baseline|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
1116299|NCT00525824|B3|Baseline|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
1116300|NCT00525824|B2|Baseline|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
1116301|NCT00525824|B1|Baseline|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
1116302|NCT00525824|P4|Participant Flow|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
1116303|NCT00525824|P3|Participant Flow|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
1116304|NCT00525824|P2|Participant Flow|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
1116305|NCT00525824|P1|Participant Flow|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
1116306|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
1116307|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
1116308|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
1116309|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
1116310|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
1116311|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
1116312|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
1116313|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
1116314|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
1116315|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
1116316|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
1116317|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
1116318|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
1116319|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
1116320|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
1116321|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
1116322|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
1116323|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
1116324|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
1116325|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
1116326|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
1116327|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
1116328|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
1116329|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
1116330|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
1116331|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
1116332|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
1116333|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
1116334|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
1116335|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
1116336|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
1118423|NCT00520234|O2|Outcome|Placebo|Normal Saline 100 cc IV daily
1116340|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
1116341|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
1116342|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
1116343|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
1116344|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
1116345|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
1116346|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
1116347|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
1116348|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
1116349|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
1116350|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
1116351|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
1116352|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
1116353|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
1116354|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
1116355|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
1116356|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
1116357|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
1116358|NCT00525824|E8|Reported Event|Simva 80 mg + Eze 10 mg|Simvastatin 80 mg + Ezetimibe 10 mg
1116359|NCT00525824|E7|Reported Event|Simva 40 mg + Eze 10 mg|Simvastatin 40 mg + Ezetimibe 10 mg
1116360|NCT00525824|E6|Reported Event|Rosu 20 mg + Eze 10 mg|Rosuvastatin 20 mg + Ezetimibe 10 mg
1116361|NCT00525824|E5|Reported Event|Rosu 10 mg + Eze 10 mg|Rosuvastatin 10 mg + Ezetimibe 10 mg
1116362|NCT00525824|E4|Reported Event|Simvastatin 80 mg|Simvastatin 80 mg Monotherapy arm
1116363|NCT00525824|E3|Reported Event|Simvastatin 40 mg|Simvastatin 40 mg Monotherapy arm
1116364|NCT00525824|E2|Reported Event|Rosuvastatin 20 mg|Rosuvastatin 20 mg Monotherapy arm
1116365|NCT00525824|E1|Reported Event|Rosuvastatin 10 mg|Rosuvastatin 10 mg Monotherapy arm
1116366|NCT00525798|B3|Baseline|Total|Total of all reporting groups
1116367|NCT00525798|B2|Baseline|Placebo|1 tablet of placebo daily
1116368|NCT00525798|B1|Baseline|SMC021|1 tablet of 0,80 mg SMC021 daily
1116369|NCT00525798|P2|Participant Flow|Placebo|1 tablet of placebo daily
1116370|NCT00525798|P1|Participant Flow|SMC021|1 tablet of 0,80 mg SMC021 daily
1116371|NCT00525798|O2|Outcome|Placebo|1 tablet of placebo daily
1116372|NCT00525798|O1|Outcome|SMC021|1 tablet of 0,80 mg SMC021 daily
1116376|NCT00525798|E1|Reported Event|SMC021|1 tablet of 0,80 mg SMC021 daily
1116377|NCT00525733|B3|Baseline|Total|Total of all reporting groups
1116378|NCT00525733|B2|Baseline|5-drug Experimental Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD + Raltegravir 400 mg BID + Maraviroc 150 mg BID~darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)~Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)~Maraviroc: Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food)~Raltegravir: Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food)"
1116379|NCT00525733|B1|Baseline|3-drug Standard Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD~darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)~Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)"
1116380|NCT00525733|P2|Participant Flow|5-drug Experimental Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD + Raltegravir 400 mg BID + Maraviroc 150 mg BID~darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)~Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)~Maraviroc: Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food)~Raltegravir: Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food)"
1116381|NCT00525733|P1|Participant Flow|3-drug Standard Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD~darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)~Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)"
1116382|NCT00525733|O2|Outcome|5-drug Experimental Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD + Raltegravir 400 mg BID + Maraviroc 150 mg BID~darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)~Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)~Maraviroc: Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food)~Raltegravir: Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food)"
1116413|NCT00525512|P3|Participant Flow|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
1116414|NCT00525512|P2|Participant Flow|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116415|NCT00525512|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
1116383|NCT00525733|O1|Outcome|3-drug Standard Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD~darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)~Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)"
1116384|NCT00525733|E2|Reported Event|5-drug Experimental Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD + Raltegravir 400 mg BID + Maraviroc 150 mg BID~darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)~Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)~Maraviroc: Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food)~Raltegravir: Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food)"
1116385|NCT00525733|E1|Reported Event|3-drug Standard Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD~darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)~Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)"
1116386|NCT00525629|B3|Baseline|Total|Total of all reporting groups
1116387|NCT00525629|B2|Baseline|Control Diet|"Isocaloric Diet with No Walnuts~Control: Control Diet with No Walnuts"
1116388|NCT00525629|B1|Baseline|Walnut Diet|"48 Grams of Walnuts Daily~Walnuts: 48 Grams of Walnuts Daily"
1116389|NCT00525629|P2|Participant Flow|Control Diet|Isocaloric Diet with no Nuts.
1116390|NCT00525629|P1|Participant Flow|Walnut Diet|48g of walnuts per day
1116391|NCT00525629|O2|Outcome|Control Diet|"Isocaloric Diet with No Walnuts~Control: Control Diet with No Walnuts"
1116392|NCT00525629|O1|Outcome|Walnut Diet|"48 Grams of Walnuts Daily~Walnuts: 48 Grams of Walnuts Daily"
1116393|NCT00525629|E2|Reported Event|Control Diet|Isocaloric Diet with no Nuts.
1116394|NCT00525629|E1|Reported Event|Walnut Diet|48g of walnuts per day
1116395|NCT00525603|B1|Baseline|CFAR|Participants received fludarabine 20 mg/m^2 days 3-5 intravenous (IV), cyclophosphamide 200 mg/m^2 days 3-5 IV, Alemtuzumab 30 mg IV days 1, 3 and 5, and rituximab 375 mg/m^2 IV on day 2 for C1 and 500mg/m^2 IV on day 2 for C2-6.
1116396|NCT00525603|P1|Participant Flow|CFAR|Participants received fludarabine 20 mg/m^2 days 3-5 intravenous (IV), cyclophosphamide 200 mg/m^2 days 3-5 IV, Alemtuzumab 30 mg IV days 1, 3 and 5, and rituximab 375 mg/m^2 IV on day 2 for C1 and 500mg/m^2 IV on day 2 for C2-6.
1116397|NCT00525603|O1|Outcome|CFAR|Participants received fludarabine 20 mg/m^2 days 3-5 intravenous (IV), cyclophosphamide 200 mg/m^2 days 3-5 IV, Alemtuzumab 30 mg IV days 1, 3 and 5, and rituximab 375 mg/m^2 IV on day 2 for C1 and 500mg/m^2 IV on day 2 for C2-6.
1116398|NCT00525603|E1|Reported Event|CFAR|Participants received fludarabine 20 mg/m^2 days 3-5 intravenous (IV), cyclophosphamide 200 mg/m^2 days 3-5 IV, Alemtuzumab 30 mg IV days 1, 3 and 5, and rituximab 375 mg/m^2 IV on day 2 for C1 and 500mg/m^2 IV on day 2 for C2-6.
1116399|NCT00525525|B3|Baseline|Total|Total of all reporting groups
1116400|NCT00525525|B2|Baseline|Safety Lead-in Group|A safety lead-in group received bevacizumab and erlotinib added to TMZ after completion of radiation to rule out unexpected toxicity of the combination of drugs.
1116446|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116401|NCT00525525|B1|Baseline|Efficacy Group|Patients treated with the combination of radiation plus temozolomide (75 mg/m2 daily during radiotherapy) plus bevacizumab (10 mg/kg IV every two weeks during radiotherapy) plus tarceva (dose based upon use of EIAED, either 200 mg daily or 500 mg daily; given daily); all treatment begins at the start of radiotherapy and continues until tumor progression, death or excessive toxicity
1116402|NCT00525525|P2|Participant Flow|Safety Lead-in Group|A safety lead-in group received bevacizumab and erlotinib added to TMZ after completion of radiation to rule out unexpected toxicity of the combination of drugs.
1116403|NCT00525525|P1|Participant Flow|Efficacy Group|Patients treated with the combination of radiation plus temozolomide (75 mg/m2 daily during radiotherapy) plus bevacizumab (10 mg/kg IV every two weeks during radiotherapy) plus tarceva (dose based upon use of EIAED, either 200 mg daily or 500 mg daily; given daily); all treatment begins at the start of radiotherapy and continues until tumor progression, death or excessive toxicity
1116404|NCT00525525|O1|Outcome|Safety Lead-in Group|A safety lead-in group received bevacizumab and erlotinib added to TMZ after completion of radiation to rule out unexpected toxicity of the combination of drugs.
1116405|NCT00525525|O1|Outcome|Efficacy Group|Patients treated with the combination of radiation plus temozolomide (75 mg/m2 daily during radiotherapy) plus bevacizumab (10 mg/kg IV every two weeks during radiotherapy) plus tarceva (dose based upon use of EIAED, either 200 mg daily or 500 mg daily; given daily); all treatment begins at the start of radiotherapy and continues until tumor progression, death or excessive toxicity
1116406|NCT00525525|O1|Outcome|Efficacy Group|Patients treated with the combination of radiation plus temozolomide (75 mg/m2 daily during radiotherapy) plus bevacizumab (10 mg/kg IV every two weeks during radiotherapy) plus tarceva (dose based upon use of EIAED, either 200 mg daily or 500 mg daily; given daily); all treatment begins at the start of radiotherapy and continues until tumor progression, death or excessive toxicity
1116407|NCT00525525|E2|Reported Event|Safety Lead-in Group|A safety lead-in group received bevacizumab and erlotinib added to TMZ after completion of radiation to rule out unexpected toxicity of the combination of drugs.
1116408|NCT00525525|E1|Reported Event|Efficacy Group|Patients treated with the combination of radiation plus temozolomide (75 mg/m2 daily during radiotherapy) plus bevacizumab (10 mg/kg IV every two weeks during radiotherapy) plus tarceva (dose based upon use of EIAED, either 200 mg daily or 500 mg daily; given daily); all treatment begins at the start of radiotherapy and continues until tumor progression, death or excessive toxicity
1116409|NCT00525512|B3|Baseline|Total|Total of all reporting groups
1116410|NCT00525512|B2|Baseline|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116411|NCT00525512|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
1116412|NCT00525512|P4|Participant Flow|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
1116416|NCT00525512|O4|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
1116417|NCT00525512|O3|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
1116418|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116419|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116420|NCT00525512|O2|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
1116421|NCT00525512|O1|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
1116422|NCT00525512|O2|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
1116423|NCT00525512|O1|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
1116424|NCT00525512|O2|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
1116425|NCT00525512|O1|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
1116426|NCT00525512|O2|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
1116427|NCT00525512|O1|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
1116428|NCT00525512|O2|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
1116429|NCT00525512|O1|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
1116430|NCT00525512|O2|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
1116431|NCT00525512|O1|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
1116432|NCT00525512|O2|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
1116433|NCT00525512|O1|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
1116434|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116435|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116436|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116437|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116438|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116439|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116440|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116441|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116442|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116443|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116444|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116445|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116447|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116448|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116449|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116450|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116451|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116452|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116453|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116454|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116455|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116456|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116457|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116458|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116459|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116460|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116461|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116462|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116463|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116464|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116465|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116466|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116467|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116468|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116469|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116470|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116471|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116472|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116473|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116474|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116475|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116476|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116478|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116479|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116480|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116481|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116482|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116483|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116484|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116485|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116486|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116487|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116488|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116489|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116490|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116491|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116492|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116493|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116494|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116495|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116496|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116497|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116498|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116499|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116500|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116501|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116502|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116503|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116504|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116505|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116506|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116507|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1128386|NCT00491374|O2|Outcome|Mometasone Furoate Nasal Spray|
1116508|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116509|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116510|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116511|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116512|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116513|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116514|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116515|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116516|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116517|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116518|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116519|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116520|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116521|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116522|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116523|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116524|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116525|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116526|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116527|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116528|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116529|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116530|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116531|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116532|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116533|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116534|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116535|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116536|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116537|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116538|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116539|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116540|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116541|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116542|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116543|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116544|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116545|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116546|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116547|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1116548|NCT00525512|E4|Reported Event|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
1116549|NCT00525512|E3|Reported Event|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
1116550|NCT00525512|E2|Reported Event|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
1116551|NCT00525512|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
1116552|NCT00525499|B5|Baseline|Total|Total of all reporting groups
1116553|NCT00525499|B4|Baseline|0.025% ASC-J9 Cream|0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
1116554|NCT00525499|B3|Baseline|0.005% ASC-J9 Cream|0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
1116555|NCT00525499|B2|Baseline|0.001% ASC-J9 Cream|0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
1116556|NCT00525499|B1|Baseline|Vehicle Control|Vehicle control cream applied topically to the face twice daily for 12 weeks
1116557|NCT00525499|P4|Participant Flow|0.025% ASC-J9 Cream|0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
1116558|NCT00525499|P3|Participant Flow|0.005% ASC-J9 Cream|0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
1116559|NCT00525499|P2|Participant Flow|0.001% ASC-J9 Cream|0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
1116560|NCT00525499|P1|Participant Flow|Vehicle Control|Vehicle control cream applied topically to the face twice daily for 12 weeks
1116561|NCT00525499|O4|Outcome|0.025% ASC-J9 Cream|0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
1116562|NCT00525499|O3|Outcome|0.005% ASC-J9 Cream|0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
1116563|NCT00525499|O2|Outcome|0.001% ASC-J9 Cream|0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
1116564|NCT00525499|O1|Outcome|Vehicle Control|Vehicle control cream applied topically to the face twice daily for 12 weeks
1116565|NCT00525499|O4|Outcome|0.025% ASC-J9 Cream|0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
1116566|NCT00525499|O3|Outcome|0.005% ASC-J9 Cream|0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
1116567|NCT00525499|O2|Outcome|0.001% ASC-J9 Cream|0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
1116568|NCT00525499|O1|Outcome|Vehicle Control|Vehicle control cream applied topically to the face twice daily for 12 weeks
1116569|NCT00525499|E4|Reported Event|0.025% ASC-J9 Cream|0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
1116570|NCT00525499|E3|Reported Event|0.005% ASC-J9 Cream|0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
1116571|NCT00525499|E2|Reported Event|0.001% ASC-J9 Cream|0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
1116572|NCT00525499|E1|Reported Event|Vehicle Control|Vehicle control cream applied topically to the face twice daily for 12 weeks
1116573|NCT00525421|B3|Baseline|Total|Total of all reporting groups
1116574|NCT00525421|B2|Baseline|Placebo|Placebo : identical placebo tablets three times per day for 12 days
1116575|NCT00525421|B1|Baseline|Curcuminoid|Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days
1116576|NCT00525421|P2|Participant Flow|Placebo|Placebo : identical placebo tablets three times per day for 12 days
1116577|NCT00525421|P1|Participant Flow|Curcuminoid|Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days
1116578|NCT00525421|O2|Outcome|Placebo|Placebo: Identical placebo tablets three times per day for 12 days
1116579|NCT00525421|O1|Outcome|Curcuminoid|Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days
1116580|NCT00525421|O2|Outcome|Placebo|Placebo: Identical placebo tablets three times per day for 12 days
1116581|NCT00525421|O1|Outcome|Curcuminoid|Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days
1116582|NCT00525421|E2|Reported Event|Placebo|Placebo: Identical placebo tablets three times per day for 12 days
1116583|NCT00525421|E1|Reported Event|Curcuminoid|Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days
1116584|NCT00525265|B3|Baseline|Total|Total of all reporting groups
1116585|NCT00525265|B2|Baseline|OPC-41061 15 mg|OPC-41061 15 mg/day
1116586|NCT00525265|B1|Baseline|OPC-41061 7.5 mg|OPC-41061 7.5 mg/day
1116587|NCT00525265|P2|Participant Flow|OPC-41061 15 mg|OPC-41061 1.5 mg/day
1116588|NCT00525265|P1|Participant Flow|OPC-41061 7.5 mg|OPC-41061 7.5 mg/day
1116589|NCT00525265|O2|Outcome|OPC-41061 15 mg|OPC-41061 15 mg/day
1116590|NCT00525265|O1|Outcome|OPC-41061 7.5 mg|OPC-41061 7.5 mg/day
1116591|NCT00525265|E2|Reported Event|OPC-41061 15 mg|OPC-41061 15 mg/day
1116592|NCT00525265|E1|Reported Event|OPC-41061 7.5 mg|OPC-41061 7.5 mg/day
1116593|NCT00525174|B3|Baseline|Total|Total of all reporting groups
1116594|NCT00525174|B2|Baseline|Bangerter Filters|Bangerter filter worn on sound eye spectacles lens full time plus at least one hour near activities
1116595|NCT00525174|B1|Baseline|Patching|2 hours daily patching of the sound eye plus one hour near activities while patching
1116596|NCT00525174|P2|Participant Flow|Bangerter Filters|Bangerter filter worn on sound eye spectacles lens full time plus at least one hour near activities
1121693|NCT00511836|B3|Baseline|Total|Total of all reporting groups
1116597|NCT00525174|P1|Participant Flow|Patching|2 hours daily patching of the sound eye plus one hour near activities while patching
1116598|NCT00525174|O2|Outcome|Patching|
1116599|NCT00525174|O1|Outcome|Bangerter|
1116600|NCT00525174|O2|Outcome|Patching|
1116601|NCT00525174|O1|Outcome|Bangerter|
1116602|NCT00525174|O2|Outcome|Patching|
1116603|NCT00525174|O1|Outcome|Bangerter|
1116604|NCT00525174|O2|Outcome|Patching|
1116605|NCT00525174|O1|Outcome|Bangerter|
1116606|NCT00525174|O2|Outcome|Patching|
1116607|NCT00525174|O1|Outcome|Bangerter|
1116608|NCT00525174|O2|Outcome|Patching|
1116609|NCT00525174|O1|Outcome|Bangerter|
1116610|NCT00525174|O2|Outcome|Patching|
1116611|NCT00525174|O1|Outcome|Bangerter|
1116612|NCT00525174|O2|Outcome|Patching|
1116613|NCT00525174|O1|Outcome|Bangerter|
1116614|NCT00525174|O2|Outcome|Patching|
1116615|NCT00525174|O1|Outcome|Bangerter|
1116616|NCT00525174|O2|Outcome|Patching|
1116617|NCT00525174|O1|Outcome|Bangerter|
1116618|NCT00525174|O2|Outcome|Patching|
1116619|NCT00525174|O1|Outcome|Bangerter|
1116620|NCT00525174|O2|Outcome|Patching|
1116621|NCT00525174|O1|Outcome|Bangerter|
1116622|NCT00525174|O2|Outcome|Patching|
1116623|NCT00525174|O1|Outcome|Bangerter|
1116624|NCT00525174|O2|Outcome|Patching|
1116625|NCT00525174|O1|Outcome|Bangerter|
1116626|NCT00525174|O2|Outcome|Patching|
1116627|NCT00525174|O1|Outcome|Bangerter|
1116628|NCT00525174|O2|Outcome|Patching|
1116629|NCT00525174|O1|Outcome|Bangerter|
1116630|NCT00525174|O2|Outcome|Patching|
1116631|NCT00525174|O1|Outcome|Bangerter|
1116632|NCT00525174|O2|Outcome|Patching|
1116633|NCT00525174|O1|Outcome|Bangerter|
1116634|NCT00525174|O2|Outcome|Patching|
1116635|NCT00525174|O1|Outcome|Bangerter|
1116636|NCT00525174|O2|Outcome|Patching|
1116637|NCT00525174|O1|Outcome|Bangerter|
1116638|NCT00525174|O2|Outcome|Patching|
1116639|NCT00525174|O1|Outcome|Bangerter|
1116640|NCT00525174|O2|Outcome|Patching|
1116641|NCT00525174|O1|Outcome|Bangerter|
1116642|NCT00525174|E2|Reported Event|Bangerter Filters|Bangerter filter worn on sound eye spectacles lens full time plus at least one hour near activities
1116643|NCT00525174|E1|Reported Event|Patching|2 hours daily patching of the sound eye plus one hour near activities while patching
1116644|NCT00525161|B1|Baseline|Sorafenib & Endocrine Therapy|"Sorafenib & Endocrine Therapy~sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first."
1116645|NCT00525161|P1|Participant Flow|Sorafenib & Endocrine Therapy|"Sorafenib & Endocrine Therapy~sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first."
1117074|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1116646|NCT00525161|O1|Outcome|Sorafenib & Endocrine Therapy|"Sorafenib & Endocrine Therapy~sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first."
1116647|NCT00525161|O1|Outcome|Sorafenib & Endocrine Therapy|"Sorafenib & Endocrine Therapy~sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first."
1116648|NCT00525161|O1|Outcome|Sorafenib & Endocrine Therapy|"Sorafenib & Endocrine Therapy~sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first."
1116649|NCT00525161|E1|Reported Event|Sorafenib & Endocrine Therapy|"Sorafenib & Endocrine Therapy~sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first."
1116650|NCT00525148|B5|Baseline|Total|Total of all reporting groups
1116651|NCT00525148|B4|Baseline|Second-line Afatinib 50 mg|Second-line patients received a starting oral dose of Afatinib 50 mg daily. Dose reduction scheme was defined for patients unable to tolerate this dose.
1116652|NCT00525148|B3|Baseline|Second-line Afatinib 40 mg|Second-line patients received a starting oral dose of Afatinib 40 mg daily only after Amendment 2. Dose reduction scheme was defined for patients unable to tolerate this dose.
1116653|NCT00525148|B2|Baseline|First-line Afatinib 50 mg|First-line patients were enrolled after Amendment 1 with a starting oral dose of Afatinib 50 mg daily. Dose reduction scheme was defined for patients unable to tolerate this dose.
1116654|NCT00525148|B1|Baseline|First-line Afatinib 40 mg|First-line patients were enrolled after Amendment 1 with a starting oral dose of Afatinib 40 mg daily after Amendment 2. Dose reduction scheme was defined for patients unable to tolerate this dose.
1116655|NCT00525148|P4|Participant Flow|Second-line Afatinib 50 mg|Second-line patients received a starting oral dose of Afatinib 50 mg daily. Dose reduction scheme was defined for patients unable to tolerate this dose.
1116656|NCT00525148|P3|Participant Flow|Second-line Afatinib 40 mg|Second-line patients received a starting oral dose of Afatinib 40 mg daily only after Amendment 2. Dose reduction scheme was defined for patients unable to tolerate this dose.
1116657|NCT00525148|P2|Participant Flow|First-line Afatinib 50 mg|First-line patients were enrolled after Amendment 1 with a starting oral dose of Afatinib 50 mg daily. Dose reduction scheme was defined for patients unable to tolerate this dose.
1116658|NCT00525148|P1|Participant Flow|First-line Afatinib 40 mg|First-line patients were enrolled after Amendment 1 with a starting oral dose of Afatinib 40 mg daily after Amendment 2. Dose reduction scheme was defined for patients unable to tolerate this dose.
1116659|NCT00525148|O2|Outcome|BIBW 50mg|Subjects receiving starting doses 50 mg of Afatinib daily.
1116660|NCT00525148|O1|Outcome|BIBW 40mg|Subjects receiving starting doses 40 mg of Afatinib daily.
1116661|NCT00525148|O2|Outcome|BIBW 50mg|Subjects receiving starting doses 50 mg of Afatinib daily.
1116662|NCT00525148|O1|Outcome|BIBW 40mg|Subjects receiving starting doses 40 mg of Afatinib daily.
1116663|NCT00525148|O3|Outcome|Afatinib 50 mg|Subjects receiving 50 mg of Afatinib daily.
1124221|NCT00505284|E1|Reported Event|Placebo|
1116664|NCT00525148|O2|Outcome|Afatinib 40 mg|Subjects receiving 40 mg of Afatinib daily.
1116665|NCT00525148|O1|Outcome|Afatinib 30 mg|Subjects receiving 30 mg of Afatinib daily.
1116666|NCT00525148|O1|Outcome|Afatinib|Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.
1116667|NCT00525148|O1|Outcome|Afatinib|Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.
1116668|NCT00525148|O1|Outcome|Afatinib|Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.
1116669|NCT00525148|O1|Outcome|Afatinib|Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.
1116670|NCT00525148|O1|Outcome|Afatinib|Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.
1116671|NCT00525148|O1|Outcome|Afatinib|Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.
1116736|NCT00524680|P3|Participant Flow|Arm III: Vitamin D 8000 IU Daily|"Patients receive 8,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
1116672|NCT00525148|O1|Outcome|Afatinib|Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.
1116673|NCT00525148|E2|Reported Event|BIBW 50mg|Subjects receiving starting doses 50 mg of Afatinib daily.
1116674|NCT00525148|E1|Reported Event|BIBW 40mg|Subjects receiving starting doses 40 mg of Afatinib daily.
1116675|NCT00525135|B1|Baseline|Study Intervention|Patients receive valproic acid daily for 16 weeks.
1116676|NCT00525135|P1|Participant Flow|Study Intervention|Patients receive valproic acid daily for 16 weeks.
1116677|NCT00525135|O1|Outcome|Study Intervention|Patients receive valproic acid daily for 16 weeks.
1116678|NCT00525135|O1|Outcome|Study Intervention|Patients receive valproic acid daily for 16 weeks.
1116679|NCT00525135|O1|Outcome|Study Intervention|Patients receive valproic acid daily for 16 weeks.
1116680|NCT00525135|O1|Outcome|Study Intervention|Patients receive valproic acid daily for 16 weeks.
1116681|NCT00525135|O1|Outcome|Study Intervention|Patients receive valproic acid daily for 16 weeks.
1116682|NCT00525135|E1|Reported Event|Study Intervention|Patients receive valproic acid daily for 16 weeks.
1116683|NCT00524940|B1|Baseline|Study Group|All participants enrolled and received Fluzone® Vaccine
1116684|NCT00524940|P1|Participant Flow|Study Group|All participants enrolled and received Fluzone® Vaccine
1116685|NCT00524940|O1|Outcome|Study Group|All participants enrolled and received Fluzone® Vaccine
1116686|NCT00524940|O1|Outcome|Study Group|All participants enrolled and received Fluzone® Vaccine
1116687|NCT00524940|E1|Reported Event|Study Group|All participants enrolled and received Fluzone® Vaccine
1116688|NCT00524771|B3|Baseline|Total|Total of all reporting groups
1116689|NCT00524771|B2|Baseline|Combined Oral Contraceptives (COC)|Users of combined oral contraceptive pills
1116690|NCT00524771|B1|Baseline|NuvaRing|Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring
1116691|NCT00524771|P2|Participant Flow|Combined Oral Contraceptives (COC)|Users of combined oral contraceptive pills
1116692|NCT00524771|P1|Participant Flow|NuvaRing|Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring
1116693|NCT00524771|O3|Outcome|COC2|A priori defined subgroup of users of combined oral contraceptive pills without desogestrel or gestodene
1116694|NCT00524771|O2|Outcome|Combined Oral Contraceptives (COC)|Users of combined oral contraceptive pills
1116695|NCT00524771|O1|Outcome|NuvaRing|Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring
1116696|NCT00524771|O3|Outcome|COC2|A priori defined subgroup of users of combined oral contraceptive pills without desogestrel or gestodene
1116697|NCT00524771|O2|Outcome|Combined Oral Contraceptives (COC)|Users of combined oral contraceptive pills
1116698|NCT00524771|O1|Outcome|NuvaRing|Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring
1116699|NCT00524771|E2|Reported Event|Combined Oral Contraceptives (COC)|Users of combined oral contraceptive pills
1116700|NCT00524771|E1|Reported Event|NuvaRing|Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring
1116701|NCT00524745|B5|Baseline|Total|Total of all reporting groups
1116702|NCT00524745|B4|Baseline|Standard (0,2,6 Month) Schedule|
1116703|NCT00524745|B3|Baseline|0,12,24 Month Schedule|
1116704|NCT00524745|B2|Baseline|0,6,12 Month Schedule|
1116705|NCT00524745|B1|Baseline|0,3,9 Month Schedule|
1116706|NCT00524745|P4|Participant Flow|Standard (0,2,6 Month) Schedule|
1116707|NCT00524745|P3|Participant Flow|0,12,24 Month Schedule|
1116708|NCT00524745|P2|Participant Flow|0,6,12 Month Schedule|
1116709|NCT00524745|P1|Participant Flow|0,3,9 Month Schedule|
1116710|NCT00524745|O4|Outcome|Standard (0,2,6 Month) Schedule|
1116711|NCT00524745|O3|Outcome|0,12,24 Month Schedule|
1116712|NCT00524745|O2|Outcome|0,6,12 Month Schedule|
1116713|NCT00524745|O1|Outcome|0,3,9 Month Schedule|
1116714|NCT00524745|O4|Outcome|Standard (0,2,6 Month) Schedule|
1116715|NCT00524745|O3|Outcome|0,12,24 Month Schedule|
1116716|NCT00524745|O2|Outcome|0,6,12 Month Schedule|
1116717|NCT00524745|O1|Outcome|0,3,9 Month Schedule|
1116718|NCT00524745|O4|Outcome|Standard (0,2,6 Month) Schedule|
1116719|NCT00524745|O3|Outcome|0,12,24 Month Schedule|
1116720|NCT00524745|O2|Outcome|0,6,12 Month Schedule|
1116721|NCT00524745|O1|Outcome|0,3,9 Month Schedule|
1116722|NCT00524745|O4|Outcome|Standard (0,2,6 Month) Schedule|
1116723|NCT00524745|O3|Outcome|0,12,24 Month Schedule|
1116724|NCT00524745|O2|Outcome|0,6,12 Month Schedule|
1116725|NCT00524745|O1|Outcome|0,3,9 Month Schedule|
1116726|NCT00524745|E4|Reported Event|Standard (0,2,6 Month) Schedule|
1116727|NCT00524745|E3|Reported Event|0,12,24 Month Schedule|
1116728|NCT00524745|E2|Reported Event|0,6,12 Month Schedule|
1116729|NCT00524745|E1|Reported Event|0,3,9 Month Schedule|
1116730|NCT00524680|B5|Baseline|Total|Total of all reporting groups
1116731|NCT00524680|B4|Baseline|Arm IV: Vitamin D 10,000 IU Daily|"Patients receive 10,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
1116732|NCT00524680|B3|Baseline|Arm III: Vitamin D 8000 IU Daily|"Patients receive 8,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
1116733|NCT00524680|B2|Baseline|Arm II: Vitamin D 6000 IU Daily|"Patients receive 6,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
1116734|NCT00524680|B1|Baseline|Arm I: Vitamin D 4000 IU Daily|"Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.~cholecalciferol: Given orally"
1116735|NCT00524680|P4|Participant Flow|Arm IV: Vitamin D 10,000 IU Daily|"Patients receive 10,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
1128387|NCT00491374|O1|Outcome|Placebo|
1116737|NCT00524680|P2|Participant Flow|Arm II: Vitamin D 6000 IU Daily|"Patients receive 6,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
1116738|NCT00524680|P1|Participant Flow|Arm I: Vitamin D 4000 IU Daily|"Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.~cholecalciferol: Given orally"
1116739|NCT00524680|O4|Outcome|Arm IV: Vitamin D 10,000 IU Daily|"Patients receive 10,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
1116740|NCT00524680|O3|Outcome|Arm III: Vitamin D 8000 IU Daily|"Patients receive 8,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
1116741|NCT00524680|O2|Outcome|Arm II: Vitamin D 6000 IU Daily|"Patients receive 6,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
1116742|NCT00524680|O1|Outcome|Arm I: Vitamin D 4000 IU Daily|"Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.~cholecalciferol: Given orally"
1116743|NCT00524680|O4|Outcome|Arm IV: Vitamin D 10,000 IU Daily|"Patients receive 10,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
1116744|NCT00524680|O3|Outcome|Arm III: Vitamin D 8000 IU Daily|"Patients receive 8,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
1116745|NCT00524680|O2|Outcome|Arm II: Vitamin D 6000 IU Daily|"Patients receive 6,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
1116746|NCT00524680|O1|Outcome|Arm I: Vitamin D 4000 IU Daily|"Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.~cholecalciferol: Given orally"
1116747|NCT00524680|O4|Outcome|Arm IV: Vitamin D 10,000 IU Daily|"Patients receive 10,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
1116748|NCT00524680|O3|Outcome|Arm III: Vitamin D 8000 IU Daily|"Patients receive 8,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
1116749|NCT00524680|O2|Outcome|Arm II: Vitamin D 6000 IU Daily|"Patients receive 6,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
1116750|NCT00524680|O1|Outcome|Arm I: Vitamin D 4000 IU Daily|"Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.~cholecalciferol: Given orally"
1116751|NCT00524680|O4|Outcome|Arm IV: Vitamin D 10,000 IU Daily|"Patients receive 10,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
1116752|NCT00524680|O3|Outcome|Arm III: Vitamin D 8000 IU Daily|"Patients receive 8,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
1116753|NCT00524680|O2|Outcome|Arm II: Vitamin D 6000 IU Daily|"Patients receive 6,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
1116754|NCT00524680|O1|Outcome|Arm I: Vitamin D 4000 IU Daily|"Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.~cholecalciferol: Given orally"
1116755|NCT00524680|E4|Reported Event|Arm IV: Vitamin D 10,000 IU Daily|"Patients receive 10,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
1116756|NCT00524680|E3|Reported Event|Arm III: Vitamin D 8000 IU Daily|"Patients receive 8,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
1116757|NCT00524680|E2|Reported Event|Arm II: Vitamin D 6000 IU Daily|"Patients receive 6,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
1116842|NCT00524394|B1|Baseline|INFANTS|INFANTS 0 to 3 days of life >1500 G OR >32 WEEKS GA
1116758|NCT00524680|E1|Reported Event|Arm I: Vitamin D 4000 IU Daily|"Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.~cholecalciferol: Given orally"
1116759|NCT00524589|B1|Baseline|Dexamethasone and Calcitriol|"Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly.~calcitriol: IV~dexamethasone: Oral~protein expression analysis: Correlative Study~laboratory biomarker analysis: Correlative Study"
1116760|NCT00524589|P1|Participant Flow|Dexamethasone and Calcitriol|"Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly.~calcitriol: IV~dexamethasone: Oral~protein expression analysis: Correlative Study~laboratory biomarker analysis: Correlative Study"
1116761|NCT00524589|O1|Outcome|Dexamethasone and Calcitriol|"Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly.~calcitriol: IV~dexamethasone: Oral~protein expression analysis: Correlative Study~laboratory biomarker analysis: Correlative Study"
1116762|NCT00524589|E1|Reported Event|Dexamethasone and Calcitriol|"Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly.~calcitriol: IV~dexamethasone: Oral~protein expression analysis: Correlative Study~laboratory biomarker analysis: Correlative Study"
1116763|NCT00524576|B3|Baseline|Total|Total of all reporting groups
1116764|NCT00524576|B2|Baseline|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
1116765|NCT00524576|B1|Baseline|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
1116766|NCT00524576|P2|Participant Flow|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
1116767|NCT00524576|P1|Participant Flow|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
1116768|NCT00524576|O2|Outcome|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
1116769|NCT00524576|O1|Outcome|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
1116770|NCT00524576|O2|Outcome|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
1116771|NCT00524576|O1|Outcome|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
1116772|NCT00524576|O2|Outcome|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
1116773|NCT00524576|O1|Outcome|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
1116774|NCT00524576|O2|Outcome|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
1116775|NCT00524576|O1|Outcome|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
1116776|NCT00524576|O2|Outcome|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
1116777|NCT00524576|O1|Outcome|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
1116778|NCT00524576|O2|Outcome|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
1116779|NCT00524576|O1|Outcome|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
1116780|NCT00524576|O2|Outcome|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
1116781|NCT00524576|O1|Outcome|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
1116782|NCT00524576|E2|Reported Event|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
1116783|NCT00524576|E1|Reported Event|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
1116784|NCT00524537|B1|Baseline|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
1116785|NCT00524537|P1|Participant Flow|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
1116786|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
1116787|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
1116788|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
1116789|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
1116790|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
1116791|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
1116792|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
1116793|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
1116794|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
1116795|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
1116796|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
1116797|NCT00524537|E1|Reported Event|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
1116798|NCT00524511|B3|Baseline|Total|Total of all reporting groups
1116799|NCT00524511|B2|Baseline|Group Receiving Standard Skin Closure Method (Surgical Staples|Women receiving standard surgical skin staples
1116800|NCT00524511|B1|Baseline|Group Receiving Alternative Skin Closure Method (Dermabond)|Women receiving Dermabond for skin closure
1116801|NCT00524511|P2|Participant Flow|Group Receiving Standard Skin Closure Method (Surgical Staples|Women receiving standard surgical skin staples
1116802|NCT00524511|P1|Participant Flow|Group Receiving Alternative Skin Closure Method (Dermabond)|Women receiving Dermabond for skin closure
1116803|NCT00524511|O2|Outcome|Group Receiving Standard Skin Closure Method (Surgical Staples|Women receiving standard surgical skin staples
1116804|NCT00524511|O1|Outcome|Group Receiving Alternative Skin Closure Method (Dermabond)|Women receiving Dermabond for skin closure
1116805|NCT00524511|O2|Outcome|Group Receiving Standard Skin Closure Method (Surgical Staples|Women receiving standard surgical skin staples
1116806|NCT00524511|O1|Outcome|Group Receiving Alternative Skin Closure Method (Dermabond)|Women receiving Dermabond for skin closure
1116807|NCT00524511|E2|Reported Event|Group Receiving Standard Skin Closure Method (Surgical Staples|Women receiving standard surgical skin staples
1116808|NCT00524511|E1|Reported Event|Group Receiving Alternative Skin Closure Method (Dermabond)|Women receiving Dermabond for skin closure
1116809|NCT00524485|B1|Baseline|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.~Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
1116822|NCT00524459|O1|Outcome|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
1116823|NCT00524459|O1|Outcome|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
1116810|NCT00524485|P1|Participant Flow|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.~Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
1116811|NCT00524485|O1|Outcome|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.~Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
1116812|NCT00524485|O1|Outcome|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.~Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
1116813|NCT00524485|O1|Outcome|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.~Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
1116839|NCT00524420|O1|Outcome|Sham rTMS|Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
1116840|NCT00524420|E2|Reported Event|Sham rTMS|Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
1116841|NCT00524420|E1|Reported Event|Active rTMS|rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
1116814|NCT00524485|O1|Outcome|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.~Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
1116815|NCT00524485|O1|Outcome|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.~Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
1116816|NCT00524485|O1|Outcome|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.~Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
1116817|NCT00524485|O1|Outcome|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.~Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
1116818|NCT00524485|E1|Reported Event|Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy|"Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.~Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart"
1116819|NCT00524459|B1|Baseline|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
1116820|NCT00524459|P1|Participant Flow|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
1116821|NCT00524459|O1|Outcome|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
1116867|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
1116824|NCT00524459|O1|Outcome|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
1116825|NCT00524459|O1|Outcome|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
1116826|NCT00524459|E1|Reported Event|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
1116827|NCT00524420|B3|Baseline|Total|Total of all reporting groups
1116828|NCT00524420|B2|Baseline|Sham rTMS|Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
1116829|NCT00524420|B1|Baseline|Active rTMS|rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
1116830|NCT00524420|P2|Participant Flow|Sham rTMS|Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
1116831|NCT00524420|P1|Participant Flow|Active rTMS|rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
1116832|NCT00524420|O2|Outcome|Sham rTMS|Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
1116833|NCT00524420|O1|Outcome|Active rTMS|rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
1116834|NCT00524420|O2|Outcome|Active rTMS|rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
1116835|NCT00524420|O1|Outcome|Sham rTMS|Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
1116836|NCT00524420|O2|Outcome|Active rTMS|rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
1116837|NCT00524420|O1|Outcome|Sham rTMS|Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
1116838|NCT00524420|O2|Outcome|Active rTMS|rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
1116924|NCT00524264|B3|Baseline|Total|Total of all reporting groups
1116843|NCT00524394|P1|Participant Flow|Infants 0 to 3 Days of Life >1500 g or >32 Weeks GA|Infants born at >32 weeks of gestagional age or > 1500gm between 0 to 3 Days of Life
1116844|NCT00524394|O1|Outcome|INFANTS 0 to 3 Days of Life (DOL) >1500 G OR >32 WEEKS GA|INFANTS 0 to 3 days of life born with >1500 gm OR >32 WEEKS gestational age
1116845|NCT00524394|E1|Reported Event|Infants0-3 Days of Life >1500g or >32 Weeks GA|Infants born at 32 weeks of gestacional age or >1500 mg at 0-3 days of life .
1116846|NCT00524368|B3|Baseline|Total|Total of all reporting groups
1116847|NCT00524368|B2|Baseline|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
1116848|NCT00524368|B1|Baseline|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
1116849|NCT00524368|P2|Participant Flow|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
1116850|NCT00524368|P1|Participant Flow|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
1116851|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
1116852|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
1116853|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
1116854|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
1116855|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
1116856|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
1116857|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
1116858|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
1116859|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
1116860|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
1116861|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
1116862|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
1116863|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
1116864|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
1116865|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
1116866|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
1116868|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
1116869|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
1116870|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
1116871|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
1116872|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
1116873|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
1116874|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
1116875|NCT00524368|E2|Reported Event|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
1116876|NCT00524368|E1|Reported Event|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
1116877|NCT00524342|B1|Baseline|IL-11|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles
1116878|NCT00524342|P1|Participant Flow|IL-11|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles
1116879|NCT00524342|O1|Outcome|IL-11|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles
1116880|NCT00524342|O1|Outcome|IL-11|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles
1116881|NCT00524342|E1|Reported Event|IL-11|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles
1116882|NCT00524316|B1|Baseline|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
1116883|NCT00524316|P1|Participant Flow|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
1116925|NCT00524264|B2|Baseline|Vehicle Solution|
1116884|NCT00524316|O1|Outcome|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
1116885|NCT00524316|O1|Outcome|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
1116886|NCT00524316|O1|Outcome|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
1116887|NCT00524316|O1|Outcome|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
1116888|NCT00524316|O1|Outcome|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
1116889|NCT00524316|O1|Outcome|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
1116890|NCT00524316|E1|Reported Event|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
1116891|NCT00524303|B4|Baseline|Total|Total of all reporting groups
1116892|NCT00524303|B3|Baseline|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
1116893|NCT00524303|B2|Baseline|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
1116990|NCT00524043|E3|Reported Event|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
1117075|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1116894|NCT00524303|B1|Baseline|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
1116895|NCT00524303|P3|Participant Flow|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
1116896|NCT00524303|P2|Participant Flow|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
1116897|NCT00524303|P1|Participant Flow|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
1116898|NCT00524303|O3|Outcome|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
1116899|NCT00524303|O2|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
1116900|NCT00524303|O1|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
1116901|NCT00524303|O3|Outcome|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
1116902|NCT00524303|O2|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
1116903|NCT00524303|O1|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
1116904|NCT00524303|O2|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
1116905|NCT00524303|O1|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
1116947|NCT00524134|O1|Outcome|Carvedilol-CR|"Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.~Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication."
1116906|NCT00524303|O3|Outcome|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel 80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
1116907|NCT00524303|O2|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel 80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
1116908|NCT00524303|O1|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams (mg)/kilogram (kg) on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter. Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel 80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
1116909|NCT00524303|O3|Outcome|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
1116910|NCT00524303|O2|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
1116911|NCT00524303|O1|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
1116912|NCT00524303|O3|Outcome|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
1116913|NCT00524303|O2|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
1116914|NCT00524303|O1|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
1116915|NCT00524303|O3|Outcome|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
1116916|NCT00524303|O2|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
1116917|NCT00524303|O1|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
1116948|NCT00524134|O1|Outcome|Carvedilol-CR|"Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.~Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication."
1117070|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1116918|NCT00524303|O3|Outcome|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
1116919|NCT00524303|O2|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
1116920|NCT00524303|O1|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
1116921|NCT00524303|E3|Reported Event|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
1116922|NCT00524303|E2|Reported Event|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
1116923|NCT00524303|E1|Reported Event|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
1116939|NCT00524225|B1|Baseline|Neumega (Interleukin 11, IL-11)|"Neumega (Oprelvekin, Interleukin 11, IL-11) 25 mcg/kg subcutaneously, given for 4 days preoperatively, and on day 5 preoperatively, and for up to 2 days postoperatively~Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure"
1116940|NCT00524225|P1|Participant Flow|Neumega (Interleukin 11, IL-11)|"Neumega (Oprelvekin, Interleukin 11, IL-11) 25 mcg/kg subcutaneously, given for 4 days preoperatively, and on day 5 preoperatively, and for up to 2 days postoperatively~Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure"
1116941|NCT00524225|O1|Outcome|Neumega (Interleukin 11, IL-11)|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure
1116942|NCT00524225|O1|Outcome|Neumega (Interleukin 11, IL-11)|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure
1116943|NCT00524225|E1|Reported Event|Neumega (Interleukin 11, IL-11)|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure
1116944|NCT00524134|B1|Baseline|Carvedilol-CR|"Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.~Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication."
1116945|NCT00524134|P1|Participant Flow|Carvedilol-CR|"Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.~Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication."
1116946|NCT00524134|O1|Outcome|Carvedilol-CR|"Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.~Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication."
1116949|NCT00524134|O1|Outcome|Carvedilol-CR|"Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.~Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication."
1116950|NCT00524134|E1|Reported Event|Carvedilol-CR|"Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.~Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication."
1116951|NCT00524121|B1|Baseline|Erlotinib in Combination With Radiotherapy|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
1116952|NCT00524121|P1|Participant Flow|Erlotinib in Combination With Radiotherapy|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
1116953|NCT00524121|O2|Outcome|EGFR Mutation|Assessed by fluorescent in situ hybridization (FISH)
1116954|NCT00524121|O1|Outcome|No EGFR Mutation|Assessed by fluorescent in situ hybridization (FISH)
1116955|NCT00524121|O2|Outcome|pEGFR>20 μg/ml|Cut at median of 20 pEGFR>20 μg/ml
1116956|NCT00524121|O1|Outcome|pEGFR<=20 μg/ml|Cut at median of 20 pEGFR<=20 μg/ml
1116957|NCT00524121|O2|Outcome|EGFR>120 μg/ml|Cut at median of 120 EGFR>120 μg/ml
1116958|NCT00524121|O1|Outcome|EGFR<=120 μg/ml|Cut at median of 120 EGFR<=120 μg/ml
1116959|NCT00524121|O3|Outcome|Never Smokers|
1116960|NCT00524121|O2|Outcome|Former Smokers|
1116961|NCT00524121|O1|Outcome|Current Smokers|
1116962|NCT00524121|O2|Outcome|Erlotinib in Combination With Radiotherapy at Week 3|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
1116963|NCT00524121|O1|Outcome|Erlotinib in Combination With Radiotherapy at Baseline|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
1116964|NCT00524121|O1|Outcome|Erlotinib in Combination With Radiotherapy|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
1116965|NCT00524121|O1|Outcome|Erlotinib in Combination With Radiotherapy|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
1116966|NCT00524121|O1|Outcome|Erlotinib in Combination With Radiotherapy|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
1116967|NCT00524121|E1|Reported Event|Erlotinib in Combination With Radiotherapy|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
1116968|NCT00524043|B4|Baseline|Total|Total of all reporting groups
1116969|NCT00524043|B3|Baseline|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
1116970|NCT00524043|B2|Baseline|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
1116971|NCT00524043|B1|Baseline|Placebo|One oral placebo tablet daily for 6 weeks.
1116972|NCT00524043|P3|Participant Flow|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
1116973|NCT00524043|P2|Participant Flow|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
1116974|NCT00524043|P1|Participant Flow|Placebo|One oral placebo tablet daily for 6 weeks.
1116975|NCT00524043|O3|Outcome|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
1116976|NCT00524043|O2|Outcome|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
1116977|NCT00524043|O1|Outcome|Placebo|One oral placebo tablet daily for 6 weeks.
1116978|NCT00524043|O3|Outcome|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
1116979|NCT00524043|O2|Outcome|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
1116980|NCT00524043|O1|Outcome|Placebo|One oral placebo tablet daily for 6 weeks.
1116981|NCT00524043|O3|Outcome|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
1116982|NCT00524043|O2|Outcome|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
1116983|NCT00524043|O1|Outcome|Placebo|One oral placebo tablet daily for 6 weeks.
1116984|NCT00524043|O3|Outcome|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
1116985|NCT00524043|O2|Outcome|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
1116986|NCT00524043|O1|Outcome|Placebo|One oral placebo tablet daily for 6 weeks.
1116987|NCT00524043|O3|Outcome|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
1116988|NCT00524043|O2|Outcome|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
1116989|NCT00524043|O1|Outcome|Placebo|One oral placebo tablet daily for 6 weeks.
1116991|NCT00524043|E2|Reported Event|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
1116992|NCT00524043|E1|Reported Event|Placebo|One oral placebo tablet daily for 6 weeks.
1116993|NCT00524030|B3|Baseline|Total|Total of all reporting groups
1116994|NCT00524030|B2|Baseline|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
1116995|NCT00524030|B1|Baseline|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
1116996|NCT00524030|P2|Participant Flow|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
1116997|NCT00524030|P1|Participant Flow|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
1116998|NCT00524030|O2|Outcome|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
1116999|NCT00524030|O1|Outcome|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
1117000|NCT00524030|O2|Outcome|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
1117001|NCT00524030|O1|Outcome|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
1117002|NCT00524030|O2|Outcome|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
1117003|NCT00524030|O1|Outcome|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
1117004|NCT00524030|O2|Outcome|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
1117005|NCT00524030|O1|Outcome|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
1117006|NCT00524030|O2|Outcome|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
1117007|NCT00524030|O1|Outcome|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
1117008|NCT00524030|O1|Outcome|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
1117009|NCT00524030|O1|Outcome|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
1117071|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117072|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117073|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117010|NCT00524030|E2|Reported Event|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
1117011|NCT00524030|E1|Reported Event|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
1117012|NCT00523991|B3|Baseline|Total|Total of all reporting groups
1117013|NCT00523991|B2|Baseline|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117014|NCT00523991|B1|Baseline|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117015|NCT00523991|P2|Participant Flow|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117016|NCT00523991|P1|Participant Flow|Placebo|Placebo matching tiotropium via HandiHaler® + Pro Re Nata (PRN) albuterol
1117017|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117018|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117019|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117020|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117021|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117022|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117023|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117024|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117025|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117026|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117027|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117028|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117029|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117030|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117031|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117032|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117033|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117034|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117035|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117036|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117037|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117038|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117039|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117040|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117041|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117042|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117043|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117044|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117045|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117046|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117047|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117048|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117049|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117050|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117051|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117052|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117053|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117054|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117055|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117056|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117057|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117058|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117059|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117060|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117061|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117062|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117063|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117064|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117065|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117066|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117067|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117068|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117069|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117076|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117077|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117078|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117079|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117080|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117081|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117082|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117083|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117084|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117085|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117086|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117087|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117088|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117089|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117090|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117091|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117092|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117093|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117094|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117095|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117096|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117097|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117098|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117099|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117100|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117101|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117102|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117103|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117104|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117105|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117106|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117107|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117108|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117109|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117110|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117111|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117112|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117113|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117114|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117115|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1124222|NCT00505076|B4|Baseline|Total|Total of all reporting groups
1117116|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117117|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117118|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117119|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117120|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117121|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117122|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117123|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117124|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117125|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117126|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117127|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117128|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117129|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117130|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117131|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117132|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117133|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117134|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117135|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117136|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117137|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117138|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117139|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117140|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1128388|NCT00491374|E2|Reported Event|Mometasone Furoate Nasal Spray|
1117141|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117142|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117143|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117144|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117145|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117146|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117147|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117148|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117149|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117150|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117151|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117152|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117153|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117154|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117155|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117156|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117157|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117158|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117159|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117160|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117161|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117162|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117163|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117164|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117165|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117166|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117167|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117168|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117169|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117170|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117171|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117172|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117173|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117174|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117175|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117176|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117177|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117178|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117179|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117180|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117181|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117182|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117183|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117184|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117185|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117186|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117187|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117188|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117189|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117190|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117191|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117192|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117193|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117194|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117195|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117196|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117197|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117198|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117199|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117200|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117201|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117202|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117203|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117204|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117205|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1128389|NCT00491374|E1|Reported Event|Placebo|
1117206|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117207|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117208|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117209|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117210|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117211|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117212|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117213|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117214|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117215|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117216|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117217|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117218|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117219|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117220|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117221|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117222|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117223|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117224|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117225|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117226|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117227|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117228|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117229|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117230|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117231|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117232|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117233|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117234|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117235|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117236|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117237|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117238|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117239|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117240|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117241|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117242|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117243|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117244|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117245|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117246|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117247|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117248|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117249|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117250|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117251|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117252|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117253|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117254|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117255|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117256|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117257|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117258|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117259|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117260|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117261|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117262|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117263|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117264|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117265|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117266|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117267|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117268|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117269|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117270|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1128390|NCT00491244|B3|Baseline|Total|Total of all reporting groups
1117271|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117272|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117273|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117274|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117275|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117276|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117277|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117278|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117279|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117280|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117281|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117282|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117283|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117284|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117285|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117286|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117287|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117288|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117289|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117290|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117291|NCT00523991|E2|Reported Event|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
1117292|NCT00523991|E1|Reported Event|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
1117293|NCT00523978|B3|Baseline|Total|Total of all reporting groups
1117294|NCT00523978|B2|Baseline|Standard Treatment With Drugs Only|a control group receiving only an Atrial Fibrillation Drug. 4 Subject withdrew consent and 1 subject was a screen failure. Therefore- Control Treatment group N= 82.
1117295|NCT00523978|B1|Baseline|Cryoablation|an experimental group receiving cryoablation and, optionally, a previously failed Atrial Fibrillation Drug.3 Subjects withdrew consent 5 subjects were a screen failure. Therefore N=163 for Experimental group.
1117296|NCT00523978|P2|Participant Flow|Standard Treatment With Drugs Only|a control group receiving only an Atrial Fibrillation Drug. 4 Subject withdrew consent and 1 subject was a screen failure. Therefore- Control Treatment group N= 82.
1117297|NCT00523978|P1|Participant Flow|Cryoablation|an experimental group receiving cryoablation and, optionally, a previously failed Atrial Fibrillation Drug.3 Subjects withdrew consent 5 subjects were a screen failure. Therefore N=163 for Experimental group.
1117298|NCT00523978|O1|Outcome|Cryoablation|Experimental group or group that were cryoablated with Arctic Front® Cardiac CryoAblation Catheter System, including the FlexCath® Steerable Sheath and Freezor® MAX Cardiac Cryoablation Catheter
1117299|NCT00523978|O2|Outcome|Standard Treatment With Drugs Only|A control group receiving only an Atrial Fibrillation Drug who have not previously failed a AF study drug.
1117300|NCT00523978|O1|Outcome|Cryoablation|Experimental group or subjects that were cryoablated with Arctic Front® Cardiac CryoAblation Catheter System, including the FlexCath® Steerable Sheath and Freezor® MAX Cardiac Cryoablation Catheter
1117301|NCT00523978|O2|Outcome|Standard Treatment With Drugs Only|A control group receiving only an Atrial Fibrillation Drug who have not previously failed a AF study drug.
1117302|NCT00523978|O1|Outcome|Cryoablation|Experimental group or subjects that were cryoablated with Arctic Front® Cardiac CryoAblation Catheter System, including the FlexCath® Steerable Sheath and Freezor® MAX Cardiac Cryoablation Catheter
1117303|NCT00523978|O2|Outcome|Standard Treatment With Drugs Only|A control group receiving only an Atrial Fibrillation Drug who have not previously failed a AF study drug.
1117304|NCT00523978|O1|Outcome|Cryoablation|Experimental group or subjects that were cryoablated with Arctic Front® Cardiac CryoAblation Catheter System, including the FlexCath® Steerable Sheath and Freezor® MAX Cardiac Cryoablation Catheter
1117305|NCT00523978|O1|Outcome|Cryoablation|Experimental group or group that were cryoablated with Arctic Front® Cardiac CryoAblation Catheter System, including the FlexCath® Steerable Sheath and Freezor® MAX Cardiac Cryoablation Catheter
1117306|NCT00523978|E2|Reported Event|Standard Treatment With Drugs Only|A control group receiving only an Atrial Fibrillation Drug who have not previously failed a AF study drug.
1117307|NCT00523978|E1|Reported Event|Cryoablation|Experimental group or subjects that were cryoablated with Arctic Front® Cardiac CryoAblation Catheter System, including the FlexCath® Steerable Sheath and Freezor® MAX Cardiac Cryoablation Catheter
1117308|NCT00523939|B3|Baseline|Total|Total of all reporting groups
1117309|NCT00523939|B2|Baseline|Leukemic|Subjects with Leukemic Meningitis
1117310|NCT00523939|B1|Baseline|Lymphomatous|Subjects with Lymphomatous Meningitis
1117311|NCT00523939|P2|Participant Flow|Leukemic|Subjects with Leukemic Meningitis
1117312|NCT00523939|P1|Participant Flow|Lymphomatous|Subjects with Lymphomatous Meningitis
1117313|NCT00523939|O2|Outcome|Leukemic|Subjects with Leukemic Meningitis
1117314|NCT00523939|O1|Outcome|Lymphomatous|Subjects with Lymphomatous Meningitis
1117315|NCT00523939|O2|Outcome|Leukemic|Subjects with Leukemic Meningitis
1117316|NCT00523939|O1|Outcome|Lymphomatous|Subjects with Lymphomatous Meningitis
1117317|NCT00523939|E1|Reported Event|All Subjects|Subjects with Lymphomatous or Leukemic Meningitis.
1117318|NCT00523848|B1|Baseline|VDT: VELCADE, Doxil and Low-dose Thalidomide|
1117319|NCT00523848|P1|Participant Flow|Arm 1 - VDT: VELCADE, Doxil and Low-dose Thalidomide|Patients receive low-dose oral thalidomide once a day on days 1-28, bortezomib IV on days 1, 4, 15, and 18, and doxorubicin hydrochloride liposome IV over 60-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
1117320|NCT00523848|O1|Outcome|VDT: VELCADE, Doxil and Low-dose Thalidomide|
1117321|NCT00523848|O1|Outcome|VDT: VELCADE, Doxil and Low-dose Thalidomide|
1117322|NCT00523848|O1|Outcome|VDT: VELCADE, Doxil and Low-dose Thalidomide|
1117323|NCT00523848|E1|Reported Event|VDT: VELCADE, Doxil and Low-dose Thalidomide|
1117324|NCT00523809|B1|Baseline|Bevacizumab + Fludarabine + Melphalan|Bevacizumab 10 mg/kg intravenous (IV) on Day 1; Fludarabine 25 mg/m^2 IV Daily over 5 Days; Melphalan 70 mg/m^2 IV Daily over 2 Days; Thymoglobulin 0.5 mg/kg IV on Day - 3, 1.5 mg/kg IV on Day - 2, and 2 mg/kg IV on Day -1; plus Allogeneic Hematopoietic Stem Cell Transplantation on Day 8.
1117325|NCT00523809|P1|Participant Flow|Bevacizumab + Fludarabine + Melphalan|Bevacizumab 10 mg/kg intravenous (IV) on Day 1; Fludarabine 25 mg/m^2 IV Daily over 5 Days; Melphalan 70 mg/m^2 IV Daily over 2 Days; Thymoglobulin 0.5 mg/kg IV on Day - 3, 1.5 mg/kg IV on Day - 2, and 2 mg/kg IV on Day -1; plus Allogeneic Hematopoietic Stem Cell Transplantation on Day 8.
1117326|NCT00523809|O1|Outcome|Bevacizumab + Fludarabine + Melphalan|Bevacizumab 10 mg/kg intravenous (IV) on Day 1; Fludarabine 25 mg/m^2 IV Daily over 5 Days; Melphalan 70 mg/m^2 IV Daily over 2 Days; Thymoglobulin 0.5 mg/kg IV on Day - 3, 1.5 mg/kg IV on Day - 2, and 2 mg/kg IV on Day -1; plus Allogeneic Hematopoietic Stem Cell Transplantation on Day 8.
1117327|NCT00523809|E1|Reported Event|Bevacizumab + Fludarabine + Melphalan|Bevacizumab 10 mg/kg intravenous (IV) on Day 1; Fludarabine 25 mg/m^2 IV Daily over 5 Days; Melphalan 70 mg/m^2 IV Daily over 2 Days; Thymoglobulin 0.5 mg/kg IV on Day - 3, 1.5 mg/kg IV on Day - 2, and 2 mg/kg IV on Day -1; plus Allogeneic Hematopoietic Stem Cell Transplantation on Day 8.
1117328|NCT00523744|B1|Baseline|Amlodipine(AML)+Olmesartan, AML+Valsartan, AML+Valsartan+HCTZ|During the Treatment Phase 1, participants received 1 week of treatment with olmesartan 10 mg and amlodipine 5 mg once daily in free combination, followed by three weeks of treatment with olmesartan 20 mg plus amlodipine 10 mg once daily in free combination. During the Treatment Phase 2 participants received amlodipine 10 mg plus valsartan 160 mg for 4 weeks. During the Extension Phase, participants received 4 weeks treatment with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg.
1117329|NCT00523744|P1|Participant Flow|Amlodipine(AML)+Olmesartan, AML+Valsartan, AML+Valsartan+HCTZ|During the Treatment Phase 1, participants received 1 week of treatment with olmesartan 10 mg and amlodipine 5 mg once daily in free combination, followed by three weeks of treatment with olmesartan 20 mg plus amlodipine 10 mg once daily in free combination. During the Treatment Phase 2 participants received amlodipine 10 mg plus valsartan 160 mg for 4 weeks. During the Extension Phase, participants received 4 weeks treatment with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg.
1117330|NCT00523744|O1|Outcome|Amlodipine+Valsartan+HCTZ - Phase 3|Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
1117331|NCT00523744|O1|Outcome|Amlodipine+Valsartan+HCTZ - Phase 3|Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
1117332|NCT00523744|O1|Outcome|Amlodipine+Valsartan+HCTZ - Phase 3|Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
1117333|NCT00523744|O1|Outcome|Amlodipine+Valsartan+HCTZ - Phase 3|Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
1117363|NCT00523705|P2|Participant Flow|Sugar Pill|Placebo tablets matched to drug.
1117334|NCT00523744|O1|Outcome|Amlodipine+Valsartan+HCTZ - Phase 3|Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
1117335|NCT00523744|O1|Outcome|Amlodipine+Valsartan - Phase 2|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
1117336|NCT00523744|O1|Outcome|Amlodipine+Valsartan - Phase 2|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
1117337|NCT00523744|O1|Outcome|Amlodipine+Valsartan+HCTZ - Phase 3|Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
1117338|NCT00523744|O1|Outcome|Amlodipine+Valsartan - Phase 2|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
1117339|NCT00523744|O1|Outcome|Amlodipine+Valsartan - Phase 2|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
1117340|NCT00523744|O1|Outcome|Amlodipine+Valsartan - Phase 2|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
1117341|NCT00523744|O1|Outcome|Amlodipine+Valsartan - Phase 2|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
1117342|NCT00523744|E3|Reported Event|Phase 3 - Amlodipine+Valsartan+HCTZ|Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
1117343|NCT00523744|E2|Reported Event|Phase 2 - Amlodipine+Valsartan|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
1117665|NCT00522418|E1|Reported Event|VNS Therapy|VNS Therapy + Best Medical Practice
1117344|NCT00523744|E1|Reported Event|Phase 1 - Amlodipine+Olmesartan|4 weeks treatment with amlodipine 10 mg plus olmesartan 20 mg taken orally once daily in the morning.
1117345|NCT00523718|B3|Baseline|Total|Total of all reporting groups
1117346|NCT00523718|B2|Baseline|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.~placebo: placebo, 1 capsule PO bid, 12 weeks"
1117347|NCT00523718|B1|Baseline|Riluzole|"Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment~riluzole: 50 mg PO bid, 12 weeks"
1117348|NCT00523718|P2|Participant Flow|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.~placebo: placebo, 1 capsule PO bid, 12 weeks"
1117349|NCT00523718|P1|Participant Flow|Riluzole|"Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment~riluzole: 50 mg PO bid, 12 weeks"
1117350|NCT00523718|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.~placebo: placebo, 1 capsule PO bid, 12 weeks"
1117351|NCT00523718|O1|Outcome|Riluzole|"Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment~riluzole: 50 mg PO bid, 12 weeks"
1117352|NCT00523718|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.~placebo: placebo, 1 capsule PO bid, 12 weeks"
1117353|NCT00523718|O1|Outcome|Riluzole|"Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment~riluzole: 50 mg PO bid, 12 weeks"
1117354|NCT00523718|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.~placebo: placebo, 1 capsule PO bid, 12 weeks"
1117355|NCT00523718|O1|Outcome|Riluzole|"Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment~riluzole: 50 mg PO bid, 12 weeks"
1117356|NCT00523718|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.~placebo: placebo, 1 capsule PO bid, 12 weeks"
1117357|NCT00523718|O1|Outcome|Riluzole|"Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment~riluzole: 50 mg PO bid, 12 weeks"
1117358|NCT00523718|E2|Reported Event|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.~placebo: placebo, 1 capsule PO bid, 12 weeks"
1117359|NCT00523718|E1|Reported Event|Riluzole|"Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment~riluzole: 50 mg PO bid, 12 weeks"
1117360|NCT00523705|B3|Baseline|Total|Total of all reporting groups
1117361|NCT00523705|B2|Baseline|Sugar Pill|Placebo tablets matched to drug.
1117362|NCT00523705|B1|Baseline|Escitalopram|Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
1117364|NCT00523705|P1|Participant Flow|Escitalopram|Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
1117365|NCT00523705|O2|Outcome|Sugar Pill|Placebo tablets matched to drug.
1117366|NCT00523705|O1|Outcome|Escitalopram|Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
1117367|NCT00523705|O2|Outcome|Sugar Pill|Placebo tablets matched to drug.
1117368|NCT00523705|O1|Outcome|Escitalopram|Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
1117369|NCT00523705|O2|Outcome|Sugar Pill|Placebo tablets matched to drug.
1117370|NCT00523705|O1|Outcome|Escitalopram|Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
1117371|NCT00523705|O2|Outcome|Sugar Pill|Placebo tablets matched to drug.
1117372|NCT00523705|O1|Outcome|Escitalopram|Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
1117373|NCT00523705|E2|Reported Event|Sugar Pill|Placebo tablets matched to drug.
1117374|NCT00523705|E1|Reported Event|Escitalopram|Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
1117375|NCT00523640|B1|Baseline|Combination of Gemcitabine, Capecitabine, and Bevacizumab|combination of gemcitabine, capecitabine, and bevacizumab
1117376|NCT00523640|P1|Participant Flow|Combination of Gemcitabine, Capecitabine, and Bevacizumab|combination of gemcitabine, capecitabine, and bevacizumab
1117377|NCT00523640|O1|Outcome|Combination of Gemcitabine, Capecitabine, and Bevacizumab|combination of gemcitabine, capecitabine, and bevacizumab
1117378|NCT00523640|O1|Outcome|Combination of Gemcitabine, Capecitabine, and Bevacizumab|combination of gemcitabine, capecitabine, and bevacizumab
1117379|NCT00523640|O1|Outcome|Combination of Gemcitabine, Capecitabine, and Bevacizumab|combination of gemcitabine, capecitabine, and bevacizumab
1117380|NCT00523640|E1|Reported Event|Combination of Gemcitabine, Capecitabine, and Bevacizumab|combination of gemcitabine, capecitabine, and bevacizumab
1117381|NCT00523614|B3|Baseline|Total|Total of all reporting groups
1117382|NCT00523614|B2|Baseline|Controls|Women without a venous thromboembolism diagnosis who are between 15 and 49 years old
1117383|NCT00523614|B1|Baseline|Cases|Women with a venous thromboembolism who are between 15 and 49 years old
1117384|NCT00523614|P2|Participant Flow|Controls|Women without a venous thromboembolism diagnosis who are between 15 and 49 years old
1117385|NCT00523614|P1|Participant Flow|Cases|Women with a venous thromboembolism who are between 15 and 49 years old
1117386|NCT00523614|O2|Outcome|Controls|Women without a venous thromboembolism who are between 15 and 49 years old
1117387|NCT00523614|O1|Outcome|Cases|Women with a venous thromboembolism who are between 15 and 49 years old
1117388|NCT00523614|E2|Reported Event|Controls|Women without a venous thromboembolism diagnosis who are between 15 and 49 years old
1117389|NCT00523614|E1|Reported Event|Cases|Women with a venous thromboembolism who are between 15 and 49 years old
1117390|NCT00523549|B3|Baseline|Total|Total of all reporting groups
1117391|NCT00523549|B2|Baseline|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
1117392|NCT00523549|B1|Baseline|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
1117393|NCT00523549|P2|Participant Flow|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
1117403|NCT00523549|O2|Outcome|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
1117394|NCT00523549|P1|Participant Flow|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
1117395|NCT00523549|O2|Outcome|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
1117396|NCT00523549|O1|Outcome|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
1117397|NCT00523549|O2|Outcome|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
1117433|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117434|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117435|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117398|NCT00523549|O1|Outcome|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
1117399|NCT00523549|O2|Outcome|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
1117400|NCT00523549|O1|Outcome|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
1117401|NCT00523549|O2|Outcome|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
1117402|NCT00523549|O1|Outcome|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
1117575|NCT00522925|B2|Baseline|2- PS433540 200mg|200mg daily for 4 weeks
1117576|NCT00522925|B1|Baseline|1- Placebo|Placebo
1117404|NCT00523549|O1|Outcome|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
1117405|NCT00523549|O2|Outcome|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
1117406|NCT00523549|O1|Outcome|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
1117407|NCT00523549|O2|Outcome|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
1117436|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117408|NCT00523549|O1|Outcome|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
1117409|NCT00523549|E2|Reported Event|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
1117410|NCT00523549|E1|Reported Event|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
1117411|NCT00523419|B1|Baseline|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
1117412|NCT00523419|P1|Participant Flow|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
1117413|NCT00523419|O1|Outcome|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
1117414|NCT00523419|O1|Outcome|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
1117415|NCT00523419|O1|Outcome|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
1117416|NCT00523419|O1|Outcome|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
1117417|NCT00523419|O1|Outcome|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
1117418|NCT00523419|O1|Outcome|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
1117419|NCT00523419|O1|Outcome|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
1117420|NCT00523419|E1|Reported Event|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
1117421|NCT00523367|B1|Baseline|COPD Patients With GERD Symptoms|Patients with a diagnosis of COPD with weekly GERD symptoms will be asked to complete GERD and quality of life questionnaires. These questionnaires queried for GERD symptoms and an assessment of overall health during the previous year.
1117422|NCT00523367|P1|Participant Flow|COPD Patients With GERD Symptoms|Patients with a diagnosis of COPD with weekly GERD symptoms will be asked to complete GERD and quality of life questionnaires. These questionnaires queried for GERD symptoms and an assessment of overall health during the previous year.
1117423|NCT00523367|O1|Outcome|COPD Patients With GERD Symptoms|Patients with a diagnosis of COPD with weekly GERD symptoms will be asked to complete GERD and quality of life questionnaires. These questionnaires queried for GERD symptoms and an assessment of overall health during the previous year.
1117424|NCT00523367|E1|Reported Event|COPD Patients With GERD Symptoms|Patients with a diagnosis of COPD with weekly GERD symptoms will be asked to complete GERD and quality of life questionnaires. These questionnaires queried for GERD symptoms and an assessment of overall health during the previous year.
1117425|NCT00523341|B3|Baseline|Total|Total of all reporting groups
1117426|NCT00523341|B2|Baseline|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117427|NCT00523341|B1|Baseline|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117428|NCT00523341|P2|Participant Flow|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117429|NCT00523341|P1|Participant Flow|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117430|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117431|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117432|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117666|NCT00522392|B3|Baseline|Total|Total of all reporting groups
1117437|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117438|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117439|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117440|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117441|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117442|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117443|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117444|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117445|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117446|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117447|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117448|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117449|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117450|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117451|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117452|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117453|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117454|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117455|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117456|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117457|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117458|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117459|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117460|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117461|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117462|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117463|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117464|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117465|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117662|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
1117466|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117467|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117468|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117469|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117470|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117471|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117472|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117473|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117474|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117475|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117476|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117477|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117478|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117479|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117480|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117481|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117482|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117483|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117484|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117485|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117486|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117487|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117488|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117489|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117490|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117491|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117492|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117493|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117494|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117663|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
1117495|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117496|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117497|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117498|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117499|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117500|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117501|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117502|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117503|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117504|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117505|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117506|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117507|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117508|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117509|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117510|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117511|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117512|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117513|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117514|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117515|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117516|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117517|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117518|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117519|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117520|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117521|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117522|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117523|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117664|NCT00522418|E2|Reported Event|Best Medical Practice|Best Medical Practice Without VNS Therapy
1117524|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
1117525|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
1117526|NCT00523341|E2|Reported Event|Denosumab/ Denosumab 60 mg Q6M|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years (total of 10 years treatment).
1117527|NCT00523341|E1|Reported Event|Placebo/ Denosumab 60 mg Q6M|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years.
1117528|NCT00523237|B1|Baseline|Raltegravir|400 mg twice daily
1117529|NCT00523237|P1|Participant Flow|Raltegravir|400 mg twice daily
1117530|NCT00523237|O1|Outcome|Enfuvirtide Switch to Raltegravir Arm|patients were switched from Enfuvirtide to Raltegravir
1117531|NCT00523237|E1|Reported Event|Raltegravir|400 mg twice daily
1117532|NCT00522951|B1|Baseline|Entire Study Population|includes all participants received treatment
1117533|NCT00522951|P2|Participant Flow|Gadoteridol Then Gadobutrol|Participants who received two injections of gadoteridol 0.1 mmol/kg body weight (bw) in Period 1, and two injections of gadobutrol 0.1 mmol/kg bw in Period 2
1117534|NCT00522951|P1|Participant Flow|Gadobutrol Then Gadoteridol|Participants who received two injections of gadobutrol 0.1 mmol/kg body weight (bw) in Period 1, and two injections of gadoteridol 0.1 mmol/kg bw in Period 2
1117535|NCT00522951|O3|Outcome|Gadoteridol (ProHance) 0.2mmol/kg bw|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
1117536|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw|Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
1117537|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw|Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
1117538|NCT00522951|O3|Outcome|Gadoteridol (ProHance) 0.2mmol/kg bw|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
1117539|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw|Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
1117540|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw|Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
1117541|NCT00522951|O3|Outcome|Gadoteridol (ProHance) 0.2mmol/kg bw|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
1117542|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw|Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
1117543|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw|Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
1117577|NCT00522925|P3|Participant Flow|3- PS433540 500mg|500mg once daily for 4 weeks
1117544|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
1117545|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
1117546|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
1117547|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
1117548|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
1117549|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
1117550|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
1117551|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
1117552|NCT00522951|O1|Outcome|Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
1117553|NCT00522951|O1|Outcome|Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
1117554|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
1117555|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
1117556|NCT00522951|O3|Outcome|Gadoteridol (ProHance) 0.2mmol/kg bw|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
1117557|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw|Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
1117558|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw|Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
1117559|NCT00522951|O3|Outcome|Gadoteridol (ProHance) 0.2mmol/kg bw|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
1117560|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw|Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
1117561|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw|Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
1117562|NCT00522951|O3|Outcome|Gadoteridol (ProHance) 0.2mmol/kg bw|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
1117563|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw|Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
1117564|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw|Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
1117565|NCT00522951|O3|Outcome|Gadoteridol (ProHance) 0.2mmol/kg bw|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
1117566|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw|Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
1117567|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw|Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
1117568|NCT00522951|O3|Outcome|Gadoteridol (ProHance) 0.2mmol/kg bw|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
1117569|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw|Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
1117570|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw|Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
1117571|NCT00522951|E2|Reported Event|ProHance Period|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw.
1117572|NCT00522951|E1|Reported Event|Gadobutrol Period|Participants received two injections (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw.
1117573|NCT00522925|B4|Baseline|Total|Total of all reporting groups
1117574|NCT00522925|B3|Baseline|3- PS433540 500mg|500mg once daily for 4 weeks
1117578|NCT00522925|P2|Participant Flow|2- PS433540 200mg|200mg daily for 4 weeks
1117579|NCT00522925|P1|Participant Flow|1- Placebo|Placebo
1117580|NCT00522925|O3|Outcome|3- PS433540 500mg|500mg once daily for 4 weeks
1117581|NCT00522925|O2|Outcome|2- PS433540 200mg|200mg daily for 4 weeks
1117582|NCT00522925|O1|Outcome|1- Placebo|Placebo
1117583|NCT00522925|E3|Reported Event|3- PS433540 500mg|500mg once daily for 4 weeks
1117584|NCT00522925|E2|Reported Event|2- PS433540 200mg|200mg daily for 4 weeks
1117585|NCT00522925|E1|Reported Event|1- Placebo|Placebo
1117586|NCT00522873|B3|Baseline|Total|Total of all reporting groups
1117587|NCT00522873|B2|Baseline|0.5mg NETA / 1.0mg E2 (Activella)|One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
1117588|NCT00522873|B1|Baseline|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
1117589|NCT00522873|P2|Participant Flow|0.5mg NETA / 1.0mg E2 (Activella)|One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
1117590|NCT00522873|P1|Participant Flow|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
1117591|NCT00522873|O2|Outcome|0.5mg NETA / 1.0mg E2 (Activella)|One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
1117592|NCT00522873|O1|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
1117593|NCT00522873|O2|Outcome|0.5mg NETA / 1.0mg E2 (Activella)|One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
1117594|NCT00522873|O1|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
1117595|NCT00522873|O1|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
1117596|NCT00522873|E2|Reported Event|0.5mg NETA / 1.0mg E2 (Activella)|One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
1117597|NCT00522873|E1|Reported Event|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
1117598|NCT00522795|B1|Baseline|PPX, Cisplatin, Radiation|"PPX: 50 mg/m2/week days 1, 8, 15, 22, 29, 36.~Cisplatin: 25 mg/m2/week days 1, 8, 15, 22, 29, 36. Cisplatin, will be administered over ½ hour in 250 cc ns weekly for 6 weeks. Cisplatin will be administered after PPX"
1117599|NCT00522795|P1|Participant Flow|PPX, Cisplatin, Radiation|"PPX: 50 mg/m2/week days 1, 8, 15, 22, 29, 36.~Cisplatin: 25 mg/m2/week days 1, 8, 15, 22, 29, 36. Cisplatin, will be administered over ½ hour in 250 cc ns weekly for 6 weeks. Cisplatin will be administered after PPX"
1117600|NCT00522795|O1|Outcome|PPX, Cisplatin, Radiation|
1117601|NCT00522795|E1|Reported Event|PPX, Cisplatin, Radiation|"PPX: 50 mg/m2/week days 1, 8, 15, 22, 29, 36.~Cisplatin: 25 mg/m2/week days 1, 8, 15, 22, 29, 36. Cisplatin, will be administered over ½ hour in 250 cc ns weekly for 6 weeks. Cisplatin will be administered after PPX"
1117602|NCT00522626|B1|Baseline|Observational|Opioid exposed pregnancies
1117603|NCT00522626|P1|Participant Flow|Observational|Opioid exposed pregnancies
1117604|NCT00522626|O1|Outcome|Trough Fetal Heart Rate|Opioid exposed pregnancies
1117605|NCT00522626|E1|Reported Event|Observational|Opioid exposed pregnancies
1117606|NCT00522457|B1|Baseline|Ertumaxomab|
1117607|NCT00522457|P1|Participant Flow|Ertumaxomab|
1117608|NCT00522457|O1|Outcome|Ertumaxomab|
1117609|NCT00522457|O1|Outcome|Ertumaxomab|
1117610|NCT00522457|O1|Outcome|Ertumaxomab|
1117611|NCT00522457|E1|Reported Event|Ertumaxomab|
1117612|NCT00522431|B1|Baseline|Fortigel|40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day)
1117613|NCT00522431|P1|Participant Flow|Fortigel|40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day)
1117614|NCT00522431|O1|Outcome|Fortigel|40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day)
1117615|NCT00522431|O1|Outcome|Fortigel|40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day)
1117616|NCT00522431|E1|Reported Event|Fortigel|40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day)
1117617|NCT00522418|B3|Baseline|Total|Total of all reporting groups
1117618|NCT00522418|B2|Baseline|Best Medical Practice|Best Medical Practice Without VNS Therapy
1117619|NCT00522418|B1|Baseline|VNS Therapy|VNS Therapy + Best Medical Practice
1117620|NCT00522418|P2|Participant Flow|Best Medical Practice|Best Medical Practice Without VNS Therapy
1117621|NCT00522418|P1|Participant Flow|VNS Therapy|VNS Therapy + Best Medical Practice
1117622|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
1117623|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
1117624|NCT00522418|O1|Outcome|Baseline Adverse Event Profile Score < 40|Population with Baseline Adverse Event Profile Score < 40
1117625|NCT00522418|O1|Outcome|Baseline Adverse Event Profile Score >= 40|Population with Baseline Adverse Event Profile Score >= 40
1117626|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
1117627|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
1117628|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
1117629|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
1117630|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
1117631|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
1117632|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
1117633|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
1117634|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
1117635|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
1117636|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
1117637|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
1117638|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
1117639|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
1117640|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
1117641|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
1117642|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
1117643|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
1117644|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
1117645|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
1117646|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
1117647|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
1117648|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
1117649|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
1117650|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
1117651|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
1117652|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
1117653|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
1117654|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
1117655|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
1117656|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
1117657|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
1117658|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
1117659|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
1117660|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
1117661|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
1117667|NCT00522392|B2|Baseline|Arm B (VD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.~bortezomib: Given IV~dexamethasone: Given PO"
1117668|NCT00522392|B1|Baseline|Arm A (VRD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.~bortezomib: Given IV~lenalidomide: Given PO~dexamethasone: Given PO"
1117669|NCT00522392|P2|Participant Flow|Arm B (VD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.~bortezomib: Given IV~dexamethasone: Given PO"
1117670|NCT00522392|P1|Participant Flow|Arm A (VRD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.~bortezomib: Given IV~lenalidomide: Given PO~dexamethasone: Given PO"
1117671|NCT00522392|O2|Outcome|Arm B (VD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.~bortezomib: Given IV~dexamethasone: Given PO"
1117672|NCT00522392|O1|Outcome|Arm A (VRD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.~bortezomib: Given IV~lenalidomide: Given PO~dexamethasone: Given PO"
1117673|NCT00522392|O2|Outcome|Arm B (VD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.~bortezomib: Given IV~dexamethasone: Given PO"
1117674|NCT00522392|O1|Outcome|Arm A (VRD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.~bortezomib: Given IV~lenalidomide: Given PO~dexamethasone: Given PO"
1117709|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117675|NCT00522392|O2|Outcome|Arm B (VD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.~bortezomib: Given IV~dexamethasone: Given PO"
1117676|NCT00522392|O1|Outcome|Arm A (VRD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.~bortezomib: Given IV~lenalidomide: Given PO~dexamethasone: Given PO"
1117677|NCT00522392|O2|Outcome|Arm B (VD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.~bortezomib: Given IV~dexamethasone: Given PO"
1117678|NCT00522392|O1|Outcome|Arm A (VRD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.~bortezomib: Given IV~lenalidomide: Given PO~dexamethasone: Given PO"
1117679|NCT00522392|E2|Reported Event|Arm B (Vd Regimen)|Arm B (Vd Regimen) Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.
1117680|NCT00522392|E1|Reported Event|Arm A (VRd Regimen)|Arm A (VRd Regimen) Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.
1117681|NCT00522379|B6|Baseline|Total|Total of all reporting groups
1117682|NCT00522379|B5|Baseline|Placebo|
1118979|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
1117683|NCT00522379|B4|Baseline|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117684|NCT00522379|B3|Baseline|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117685|NCT00522379|B2|Baseline|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117686|NCT00522379|B1|Baseline|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117687|NCT00522379|P5|Participant Flow|Placebo|
1117688|NCT00522379|P4|Participant Flow|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117689|NCT00522379|P3|Participant Flow|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117690|NCT00522379|P2|Participant Flow|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117691|NCT00522379|P1|Participant Flow|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117692|NCT00522379|O5|Outcome|Placebo|
1117693|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117694|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117695|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117696|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117697|NCT00522379|O5|Outcome|Placebo|
1117698|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117699|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117700|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117701|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117702|NCT00522379|O5|Outcome|Placebo|
1117703|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117704|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117705|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117706|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117707|NCT00522379|O5|Outcome|Placebo|
1117708|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117710|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117711|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117712|NCT00522379|O5|Outcome|Placebo|
1117713|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117714|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117715|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117716|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117717|NCT00522379|O5|Outcome|Placebo|
1117718|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117719|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117720|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117721|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117722|NCT00522379|O5|Outcome|Placebo|
1117723|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117724|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117725|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117726|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117727|NCT00522379|O5|Outcome|Placebo|
1117728|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117729|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117730|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117731|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117732|NCT00522379|O5|Outcome|Placebo|
1117733|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117734|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117735|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117736|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117737|NCT00522379|O5|Outcome|Placebo|
1117738|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117739|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117740|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117741|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117742|NCT00522379|O5|Outcome|Placebo|
1117743|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117744|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117745|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117746|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117747|NCT00522379|O5|Outcome|Placebo|
1117748|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117749|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117750|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117751|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117752|NCT00522379|O5|Outcome|Placebo|
1117753|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117754|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117755|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117756|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117757|NCT00522379|O5|Outcome|Placebo|
1117758|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117759|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117760|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117761|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117762|NCT00522379|O5|Outcome|Placebo|
1117763|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117764|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117765|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117766|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117767|NCT00522379|O5|Outcome|Placebo|
1117768|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117769|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117770|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117771|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117772|NCT00522379|O5|Outcome|Placebo|
1117773|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117774|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117775|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117776|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117777|NCT00522379|O5|Outcome|Placebo|
1117778|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117779|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117780|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117781|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117782|NCT00522379|O5|Outcome|Placebo|
1117783|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117784|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117785|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117786|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117787|NCT00522379|E5|Reported Event|Placebo|
1117788|NCT00522379|E4|Reported Event|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117789|NCT00522379|E3|Reported Event|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
1117790|NCT00522379|E2|Reported Event|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117791|NCT00522379|E1|Reported Event|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
1117792|NCT00522301|B1|Baseline|Oral Sorafenib (BAY43-9006)|Sorafenib will be administered as 400 mg orally daily x 28 days (continuous).
1117793|NCT00522301|P1|Participant Flow|Oral Sorafenib (BAY43-9006)|Sorafenib will be administered as 400 mg orally daily x 28 days (continuous).
1117794|NCT00522301|O1|Outcome|Oral Sorafenib (BAY43-9006)|Sorafenib will be administered as 400 mg orally daily x 28 days (continuous).
1117795|NCT00522301|E1|Reported Event|Oral Sorafenib (BAY43-9006)|Sorafenib will be administered as 400 mg orally daily x 28 days (continuous).
1117796|NCT00522275|B1|Baseline|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
1117797|NCT00522275|P1|Participant Flow|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
1117798|NCT00522275|O1|Outcome|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
1117799|NCT00522275|O1|Outcome|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
1117800|NCT00522275|O1|Outcome|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
1117801|NCT00522275|O1|Outcome|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
1117802|NCT00522275|O1|Outcome|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
1117803|NCT00522275|E1|Reported Event|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
1117804|NCT00522171|B3|Baseline|Total|Total of all reporting groups
1117820|NCT00522041|O2|Outcome|Placebo|Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
1117866|NCT00521599|B1|Baseline|MF DPI 2 x 100 mcg BID|2 inhalations of mometasone furoate dry powder inhaler (MF DPI) 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily (BID) for 8 weeks
1117805|NCT00522171|B2|Baseline|Harmonic® Technology|"Harmonic® Sharp Curved Blade (HF105) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery.~The Harmonic® Synergy™ Curved Blade (SNGCB) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures, Ear Nose and Throat (ENT), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery.~These devices were not modified from their commercially available specifications."
1117806|NCT00522171|B1|Baseline|Electro Surgery|Electro Surgical instruments are used to cut and coagulate tissue using alternating electric current at the surgical site. In Electro Surgery, the patient is included in the circuit and current enters the patient's body.
1117807|NCT00522171|P2|Participant Flow|Harmonic® Technology|"Harmonic® Sharp Curved Blade (HF105) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery.~The Harmonic® Synergy™ Curved Blade (SNGCB) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures, Ear Nose and Throat (ENT), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery.~These devices were not modified from their commercially available specifications."
1117808|NCT00522171|P1|Participant Flow|Electro Surgery|Electro Surgical instruments are used to cut and coagulate tissue using alternating electric current at the surgical site. In Electro Surgery, the patient is included in the circuit and current enters the patient's body.
1117809|NCT00522171|O2|Outcome|Harmonic® Technology|"Harmonic® Sharp Curved Blade (HF105) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery.~The Harmonic® Synergy™ Curved Blade (SNGCB) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures, Ear Nose and Throat (ENT), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery.~These devices were not modified from their commercially available specifications."
1128488|NCT00490945|O4|Outcome|50 mg VEC-162|Randomized to 50 mg VEC-162
1117810|NCT00522171|O1|Outcome|Electro Surgery|Electro Surgical instruments are used to cut and coagulate tissue using alternating electric current at the surgical site. In Electro Surgery, the patient is included in the circuit and current enters the patient's body.
1117811|NCT00522171|O2|Outcome|Harmonic® Technology|"Harmonic® Sharp Curved Blade (HF105) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery.~The Harmonic® Synergy™ Curved Blade (SNGCB) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures, Ear Nose and Throat (ENT), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery.~These devices were not modified from their commercially available specifications."
1117812|NCT00522171|O1|Outcome|Electro Surgery|Electro Surgical instruments are used to cut and coagulate tissue using alternating electric current at the surgical site. In Electro Surgery, the patient is included in the circuit and current enters the patient's body.
1117813|NCT00522171|E2|Reported Event|Harmonic® Technology|"Harmonic® Sharp Curved Blade (HF105) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery.~The Harmonic® Synergy™ Curved Blade (SNGCB) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures, Ear Nose and Throat (ENT), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery.~These devices were not modified from their commercially available specifications."
1117814|NCT00522171|E1|Reported Event|Electro Surgery|Electro Surgical instruments are used to cut and coagulate tissue using alternating electric current at the surgical site. In Electro Surgery, the patient is included in the circuit and current enters the patient's body.
1117815|NCT00522041|B3|Baseline|Total|Total of all reporting groups
1117816|NCT00522041|B2|Baseline|Placebo|Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
1117817|NCT00522041|B1|Baseline|Cellegesic (Nitroglycerin 0.4%)|Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
1117818|NCT00522041|P2|Participant Flow|Placebo|Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
1117819|NCT00522041|P1|Participant Flow|Cellegesic (Nitroglycerin 0.4%)|Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
1117821|NCT00522041|O1|Outcome|Cellegisic (Nitroglycerin 0.4%)|Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
1117822|NCT00522041|O2|Outcome|Placebo|Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
1117823|NCT00522041|O1|Outcome|Cellegisic (Nitroglycerin 0.4%)|Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
1117824|NCT00522041|O2|Outcome|Placebo|Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
1117825|NCT00522041|O1|Outcome|Cellegesic (Nitroglycerin 0.4%)|Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
1117826|NCT00522041|E2|Reported Event|Placebo|Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
1117827|NCT00522041|E1|Reported Event|Cellegesic (Nitroglycerin 0.4%)|Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
1117828|NCT00521989|B6|Baseline|Total|Total of all reporting groups
1117829|NCT00521989|B5|Baseline|Placebo|"Placebo~Placebo: Placebo"
1117830|NCT00521989|B4|Baseline|Prednisolone|"Prednisolone 2.7 mg~Prednisolone: Prednisolone"
1117831|NCT00521989|B3|Baseline|CRx-102 (2.7/360 mg)|"CRx-102 Dose 3 (2.7 mg prednisolone + 360 mg dipyridamole)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
1117832|NCT00521989|B2|Baseline|CRx-102 (2.7/180 mg)|"CRx-102 Dose 2 (2.7 mg prednisolone + 180 mg dipyridamole)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
1117833|NCT00521989|B1|Baseline|CRx-102 (2.7/90 mg)|"CRx-102 (Prednisolone 2.7 mg + Dipyridamole 90 mg)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
1117834|NCT00521989|P5|Participant Flow|Placebo|"Placebo~Placebo: Placebo"
1117835|NCT00521989|P4|Participant Flow|Prednisolone|"Prednisolone 2.7 mg~Prednisolone: Prednisolone"
1117836|NCT00521989|P3|Participant Flow|CRx-102 (2.7/360 mg)|"CRx-102 Dose 3 (2.7 mg prednisolone + 360 mg dipyridamole)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
1117837|NCT00521989|P2|Participant Flow|CRx-102 (2.7/180 mg)|"CRx-102 Dose 2 (2.7 mg prednisolone + 180 mg dipyridamole)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
1128489|NCT00490945|O3|Outcome|20 mg VEC-162|Randomized to 20 mg VEC-162
1117838|NCT00521989|P1|Participant Flow|CRx-102 (2.7/90 mg)|"CRx-102 (Prednisolone 2.7 mg + Dipyridamole 90 mg)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
1117839|NCT00521989|O5|Outcome|Placebo|"Placebo~Placebo: Placebo"
1117840|NCT00521989|O4|Outcome|Prednisolone|"Prednisolone 2.7 mg~Prednisolone: Prednisolone"
1117841|NCT00521989|O3|Outcome|CRx-102 (2.7/360 mg)|"CRx-102 Dose 3 (2.7 mg prednisolone + 360 mg dipyridamole)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
1117842|NCT00521989|O2|Outcome|CRx-102 (2.7/180 mg)|"CRx-102 Dose 2 (2.7 mg prednisolone + 180 mg dipyridamole)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
1117843|NCT00521989|O1|Outcome|CRx-102 (2.7/90 mg)|"CRx-102 (Prednisolone 2.7 mg + Dipyridamole 90 mg)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
1117844|NCT00521989|E5|Reported Event|CRx-102 (2.7/360 mg)|CRx-102 dose 3 (2.7 mg prednisolone + 360 mg dipyridamole)
1117845|NCT00521989|E4|Reported Event|CRx-102 (2.7/180 mg)|CRx-102 dose 2 (2.7 mg prednisolone + 180 mg dipyridamole)
1117846|NCT00521989|E3|Reported Event|CRx-102 (2.7/90 mg)|CRx-102 dose 1 (2.7 mg prednisolone + 90 mg dipyridamole)
1117847|NCT00521989|E2|Reported Event|Prednisolone|Prednisolone 2.7 mg
1117848|NCT00521989|E1|Reported Event|Placebo|Placebo
1117849|NCT00521976|B1|Baseline|Group 1|Men and women admitted with chest pain and a suspicious acute coronary syndrome (ACS)
1117850|NCT00521976|P1|Participant Flow|Group 1|Men and women admitted with chest pain and a suspicious acute coronary syndrome (ACS)
1117851|NCT00521976|O1|Outcome|Group 1|Men and women admitted with chest pain and a suspicious acute coronary syndrome (ACS)
1117852|NCT00521976|O1|Outcome|Group 1|Men and women admitted with chest pain and a suspicious acute coronary syndrome (ACS)
1117853|NCT00521976|E1|Reported Event|Group 1|Men and women admitted with chest pain and a suspicious acute coronary syndrome (ACS)
1117854|NCT00521924|B3|Baseline|Total|Total of all reporting groups
1117855|NCT00521924|B2|Baseline|Basic Treatment (DMARDs)|Rheumatoid Arthritis basic therapy (disease modifying anti-rheumatic drugs [DMARDs])
1117856|NCT00521924|B1|Baseline|Infliximab + Basic Treatment|3 mg/kg infliximab plus basic treatment
1117857|NCT00521924|P2|Participant Flow|Basic Treatment (DMARDs)|Rheumatoid Arthritis basic therapy (disease modifying anti-rheumatic drugs [DMARDs])
1117858|NCT00521924|P1|Participant Flow|Infliximab + Basic Treatment|3 mg/kg infliximab plus basic treatment
1117859|NCT00521924|O2|Outcome|Basic Treatment (DMARDs)|Rheumatoid Arthritis basic therapy (disease modifying anti-rheumatic drugs [DMARDs])
1117860|NCT00521924|O1|Outcome|Infliximab + Basic Treatment|3 mg/kg infliximab plus basic treatment
1117861|NCT00521924|E2|Reported Event|Basic Treatment (DMARDs)|Rheumatoid Arthritis basic therapy (disease modifying anti-rheumatic drugs [DMARDs])
1117862|NCT00521924|E1|Reported Event|Infliximab + Basic Treatment|3 mg/kg infliximab plus basic treatment
1117863|NCT00521599|B4|Baseline|Total|Total of all reporting groups
1117864|NCT00521599|B3|Baseline|Placebo BID|2 inhalations of placebo matching MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
1117865|NCT00521599|B2|Baseline|MF DPI 1 x 200 mcg BID|1 inhalation of MF DPI 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily for 8 weeks
1118081|NCT00521079|E1|Reported Event|vBloc|Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
1117867|NCT00521599|P3|Participant Flow|Placebo BID|2 inhalations of placebo matching MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
1117868|NCT00521599|P2|Participant Flow|MF DPI 1 x 200 mcg BID|1 inhalation of MF DPI 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily for 8 weeks
1117869|NCT00521599|P1|Participant Flow|MF DPI 2 x 100 mcg BID|2 inhalations of mometasone furoate dry powder inhaler (MF DPI) 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily (BID) for 8 weeks
1117870|NCT00521599|O3|Outcome|Placebo BID|2 inhalations of placebo matching MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
1117871|NCT00521599|O2|Outcome|MF DPI 1 x 200 mcg BID|1 inhalation of MF DPI 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily for 8 weeks
1117872|NCT00521599|O1|Outcome|MF DPI 2 x 100 mcg BID|2 inhalations of mometasone furoate dry powder inhaler (MF DPI) 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily (BID) for 8 weeks
1117873|NCT00521599|E4|Reported Event|Placebo|2 inhalations of placebo matching MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
1117874|NCT00521599|E3|Reported Event|MF DPI 1 x 200 Mcg BID|1 inhalation of mometasone furoate dry powder inhaler (MF DPI) 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily (BID) for 8 weeks
1117875|NCT00521599|E2|Reported Event|MF DPI 2 x 100 mcg BID|2 inhalations of MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
1117876|NCT00521599|E1|Reported Event|OL 1 X 200 mcg BID|Open-label MF DPI 200 mcg BID
1117877|NCT00521586|B3|Baseline|Total|Total of all reporting groups
1117878|NCT00521586|B2|Baseline|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117927|NCT00521586|E11|Reported Event|Placebo+TIV/13vPnC: 13vPnC (Year 5)|Participants who received 0.5-mL Placebo matched to 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL dose of 13vPnC 1 month after, then 0.5 mL dose of 13vPnC 5 years after initial vaccination, were assessed for 1 month after 13vPnC given at Year 5.
1118021|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
1117879|NCT00521586|B1|Baseline|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117880|NCT00521586|P2|Participant Flow|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117881|NCT00521586|P1|Participant Flow|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117882|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117955|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
1118002|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
1124487|NCT00504166|B2|Baseline|Placebo|placebo to match alendronate sodium
1117883|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117884|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117885|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117886|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117928|NCT00521586|E10|Reported Event|Placebo+TIV/13vPnC: Years 1-4|Participants who received 0.5-mL Placebo matched to 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL dose of 13vPnC 1 month after, were assessed from 6-month follow-up visit at Year 0 to revaccination with 13vPnC given at Year 5.
1117929|NCT00521586|E9|Reported Event|Placebo+TIV/13vPnC: 6 Month Follow-up (Year 0)|Participants who received 0.5-mL Placebo matched to 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL dose of 13vPnC 1 month after, were assessed at the 6-month follow-up visit.
1118220|NCT00520676|O2|Outcome|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
1117887|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117888|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117889|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117890|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117891|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117892|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117893|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117894|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117930|NCT00521586|E8|Reported Event|Placebo+TIV/13vPnC: Dose 2 (Year 0)|Participants who received 0.5-mL dose of 13vPnC 1 month after Dose 1 (Dose 2), were assessed for 1 month after Dose 2.
1117931|NCT00521586|E7|Reported Event|Placebo+TIV/13vPnC: Dose 1 (Year 0)|Participants who received 0.5-mL Placebo matched to 13vPnC along with 0.5-mL TIV at Year 0 on Day 1 (Dose 1), were assessed for 1 month after Dose 1.
1117934|NCT00521586|E4|Reported Event|13vPnC+TIV/Placebo: Years 1-4|Participants who received 0.5-mL dose of 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL Placebo matched to 13vPnC 1 month after, were assessed from 6-month follow-up visit at Year 0 to revaccination with 13vPnC given at Year 5.
1117895|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117896|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117897|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117898|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117899|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117900|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117901|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117902|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117932|NCT00521586|E6|Reported Event|13vPnC+TIV/Placebo: 6 Month Follow-up (Year 5)|Participants who received 0.5-mL dose of 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL Placebo matched to 13vPnC 1 month after, then 0.5 mL dose of 13vPnC 5 years after initial vaccination, were assessed at the 6-month follow-up visit.
1117936|NCT00521586|E2|Reported Event|13vPnC+TIV/Placebo: Dose 2 (Year 0)|Participants who received 0.5-mL Placebo matched to 13vPnC 1 month after Dose 1 (Dose 2), were assessed for 1 month after Dose 2.
1117903|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117904|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117905|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117973|NCT00521352|P2|Participant Flow|Sham|"Placebo repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (sham) : Generates a field with the same parameters as active rTMS (see active arm for parameters), however, the actual magnetic fields are blocked by an electromagnetic shield built into a sham coil. The field is impeded from stimulating the brain."
1117906|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117907|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117908|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117909|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117933|NCT00521586|E5|Reported Event|13vPnC+TIV/Placebo: 13vPnC (Year 5)|Participants who received 0.5-mL dose of 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL Placebo matched to 13vPnC 1 month after, then 0.5 mL dose of 13vPnC 5 years after initial vaccination, were assessed for 1 month after 13vPnC given at Year 5.
1117935|NCT00521586|E3|Reported Event|13vPnC+TIV/Placebo: 6 Month Follow-up (Year 0)|Participants who received 0.5-mL dose of 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL Placebo matched to 13vPnC 1 month after, were assessed at the 6-month follow-up visit.
1117910|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117911|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm on Day 1(Dose 1). Placebo matched to 13vPnC vaccine (dose 2) was administered 1 month after vaccination 1, dose 1 (13vPnC+TIV).Participants were then followed-up to 4 years (for 1 month, then 6 month and then yearly follow-up) after dose 2 of vaccination 1. Participants then received 0.5 mL dose of 13vPnC vaccine intramuscular injection into the deltoid muscle of the left arm 5 years after vaccination 1. Participants were further followed-up for 1 month and then for 6 months.
1117912|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117974|NCT00521352|P1|Participant Flow|Active|"Active repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (active) : Strong electromagnetic field (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) for 30min, five sessions a week for up to eight weeks."
1117913|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117914|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117915|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117916|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117925|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1128490|NCT00490945|O2|Outcome|10 mg VEC-162|Randomized to 10 mg VEC-162
1117917|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117918|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117956|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
1118042|NCT00521339|O1|Outcome|Apremilast 20 mg|Apremilast 20mg capsules PO BID for Days 1 through 85 administered during the treatment phase
1117919|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117920|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117921|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm on Day 1(Dose 1). Placebo matched to 13vPnC vaccine (dose 2) was administered 1 month after vaccination 1, dose 1 (13vPnC+TIV).Participants were then followed-up to 4 years (for 1 month, then 6 month and then yearly follow-up) after dose 2 of vaccination 1. Participants then received 0.5 mL dose of 13vPnC vaccine intramuscular injection into the deltoid muscle of the left arm 5 years after vaccination 1. Participants were further followed-up for 1 month and then for 6 months.
1117922|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117923|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117924|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
1117926|NCT00521586|E12|Reported Event|Placebo+TIV/13vPnC: 6 Month Follow-up (Year 5)|Participants who received 0.5-mL Placebo matched to 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL dose of 13vPnC 1 month after, then 0.5 mL dose of 13vPnC 5 years after initial vaccination, were assessed at the 6-month follow-up visit.
1117937|NCT00521586|E1|Reported Event|13vPnC+TIV/Placebo: Dose 1 (Year 0)|Participants who received 0.5-mL dose of 13vPnC along with 0.5-mL TIV at Year 0 on Day 1 (Dose 1), were assessed for 1 month after Dose 1.
1117938|NCT00521456|B3|Baseline|Total|Total of all reporting groups
1117939|NCT00521456|B2|Baseline|Vehicle Solution|
1117940|NCT00521456|B1|Baseline|Ketorolac Solution|
1117941|NCT00521456|P2|Participant Flow|Vehicle Solution|
1117942|NCT00521456|P1|Participant Flow|Ketorolac Solution|
1117943|NCT00521456|O2|Outcome|Vehicle Solution|
1117944|NCT00521456|O1|Outcome|Ketorolac Solution|
1117945|NCT00521456|O2|Outcome|Vehicle Solution|
1117946|NCT00521456|O1|Outcome|Ketorolac Solution|
1117947|NCT00521456|O2|Outcome|Vehicle Solution|
1117948|NCT00521456|O1|Outcome|Ketorolac Solution|
1117949|NCT00521456|O2|Outcome|Vehicle Solution|
1117950|NCT00521456|O1|Outcome|Ketorolac Solution|
1117951|NCT00521456|E2|Reported Event|Vehicle Solution|
1117952|NCT00521456|E1|Reported Event|Ketorolac Solution|
1117953|NCT00521365|B1|Baseline|Quetiapine 600 mg|Quetiapine Extended release 600 mg per day either as monotherapy or combined therapy
1117954|NCT00521365|P1|Participant Flow|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
1117957|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
1117958|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
1117959|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
1117960|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
1117961|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
1117962|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
1117963|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
1117964|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
1117965|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
1118020|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
1117966|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
1117967|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
1117968|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
1117969|NCT00521365|E1|Reported Event|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
1117970|NCT00521352|B3|Baseline|Total|Total of all reporting groups
1117971|NCT00521352|B2|Baseline|Sham|"Placebo repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (sham) : Generates a field with the same parameters as active rTMS (see active arm for parameters), however, the actual magnetic fields are blocked by an electromagnetic shield built into a sham coil. The field is impeded from stimulating the brain."
1117972|NCT00521352|B1|Baseline|Active|"Active repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (active) : Strong electromagnetic field (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) for 30min, five sessions a week for up to eight weeks."
1118001|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
1117975|NCT00521352|O2|Outcome|Sham|"Placebo repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (sham) : Generates a field with the same parameters as active rTMS (see active arm for parameters), however, the actual magnetic fields are blocked by an electromagnetic shield built into a sham coil. The field is impeded from stimulating the brain."
1117976|NCT00521352|O1|Outcome|Active|"Active repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (active) : Strong electromagnetic field (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) for 30min, five sessions a week for up to eight weeks."
1117977|NCT00521352|O2|Outcome|Sham|"Placebo repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (sham) : Generates a field with the same parameters as active rTMS (see active arm for parameters), however, the actual magnetic fields are blocked by an electromagnetic shield built into a sham coil. The field is impeded from stimulating the brain."
1117978|NCT00521352|O1|Outcome|Active|"Active repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (active) : Strong electromagnetic field (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) for 30min, five sessions a week for up to eight weeks."
1117979|NCT00521352|O2|Outcome|Sham|"Placebo repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (sham) : Generates a field with the same parameters as active rTMS (see active arm for parameters), however, the actual magnetic fields are blocked by an electromagnetic shield built into a sham coil. The field is impeded from stimulating the brain."
1117980|NCT00521352|O1|Outcome|Active|"Active repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (active) : Strong electromagnetic field (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) for 30min, five sessions a week for up to eight weeks."
1117981|NCT00521352|E2|Reported Event|Sham|"Placebo repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (sham) : Generates a field with the same parameters as active rTMS (see active arm for parameters), however, the actual magnetic fields are blocked by an electromagnetic shield built into a sham coil. The field is impeded from stimulating the brain."
1117982|NCT00521352|E1|Reported Event|Active|"Active repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (active) : Strong electromagnetic field (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) for 30min, five sessions a week for up to eight weeks."
1117983|NCT00521339|B1|Baseline|Apremilast 20 mg (Treatment Phase)|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
1117984|NCT00521339|P3|Participant Flow|Apremilast 20mg/30mg|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension phase
1117985|NCT00521339|P2|Participant Flow|Apremilast 20mg/20mg|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were responders (achieved a 75% reduction in the Psoriasis Area Severity Index [PASI-75]) continued to receive 20 mg apremilast BID during the 12-week extension phase (Weeks 12-24).
1117986|NCT00521339|P1|Participant Flow|Apremilast 20mg|Participants received 20mg Apremilast capsules by mouth (PO) twice a day (BID) on Days 1 through 85 during the Treatment Phase
1117987|NCT00521339|O1|Outcome|Apremilast 20mg/30mg PO BID (Treatment + Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension
1117988|NCT00521339|O1|Outcome|Apremilast 20mg/30mg PO BID (Treatment + Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension
1117989|NCT00521339|O1|Outcome|Apremilast 20mg BID/30mg PO BID (Treatment + Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension
1117990|NCT00521339|O1|Outcome|Apremilast 20mg/30mg PO BID (Treatment + Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension phase
1117991|NCT00521339|O1|Outcome|Apremilast 20mg/30mg PO BID (Treatment + Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension phase
1117992|NCT00521339|O1|Outcome|Apremilast 20mg BID/30mg PO BID (Treatment + Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension phase
1117993|NCT00521339|O1|Outcome|Apremilast 20mg/30mg PO BID (Treatment + Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension phase
1117994|NCT00521339|O1|Outcome|Apremilast 20/30mg BID|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension phase
1117995|NCT00521339|O1|Outcome|Apremilast 20 mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
1117996|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
1117997|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
1117998|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
1117999|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
1118000|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
1118080|NCT00521079|E2|Reported Event|Placebo|Subjects implanted with a functional Maestro System device that does NOT delivers therapy (Therapy OFF).
1118003|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
1118004|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
1118005|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
1118006|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
1118007|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
1118008|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
1118009|NCT00521339|O2|Outcome|Apremilast 20mg/30mg (Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension
1118010|NCT00521339|O1|Outcome|Apremilast 20mg/20mg (Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were responders (achieved a 75% reduction in the Psoriasis Area Severity Index [PASI-75]) continued to receive 20 mg apremilast BID during the 12-week extension phase (Weeks 12-24).
1118011|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
1118012|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
1118013|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
1118014|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
1118015|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
1118016|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
1118017|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
1118018|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
1118019|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
1118221|NCT00520676|O1|Outcome|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
1118022|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
1118023|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
1118024|NCT00521339|O1|Outcome|Apremilast 20mg PO BID|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
1118025|NCT00521339|O1|Outcome|Apremilast 20mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
1118026|NCT00521339|O1|Outcome|Apremilast 20mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
1118027|NCT00521339|O1|Outcome|Apremilast 20mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
1118028|NCT00521339|O1|Outcome|Apremilast 20mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
1118029|NCT00521339|O1|Outcome|Apremilast 20mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
1118030|NCT00521339|O1|Outcome|Apremilast 20mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
1118031|NCT00521339|O1|Outcome|Apremilast 20mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
1118032|NCT00521339|O1|Outcome|Apremilast 20mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
1118033|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) am and pm for Days 1 through 85 administered during the Treatment Phase
1118034|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) am and pm for Days 1 through 85 administered during the Treatment Phase
1118035|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) am and pm for Days 1 through 85 administered during the Treatment Phase
1118036|NCT00521339|O1|Outcome|Apremilast 20 mg|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
1118037|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
1118038|NCT00521339|O1|Outcome|Apremilast 20 mg|Apremilast 20mg capsules PO BID for Days 1 through 85 administered during the treatment phase
1118039|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) am and pm for Days 1 through 85 administered during the Treatment Phase
1118040|NCT00521339|O1|Outcome|Apremilast 20 mg|Apremilast 20mg capsules PO BID on Days 1 through 85 administered during the treatment phase
1118041|NCT00521339|O1|Outcome|Apremilast 20 mg|Apremilast 20mg capsules PO BID for Days 1 through 85 administered during the treatment phase
1118255|NCT00520572|O2|Outcome|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
1118043|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
1118044|NCT00521339|O1|Outcome|Apremilast 20 mg|Apremilast 20mg capsules PO BID on Days 1 through 85 administered during the Treatment Phase
1118045|NCT00521339|E3|Reported Event|Apremilast 20mg/30mg (Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension
1118046|NCT00521339|E2|Reported Event|Apremilast 20mg/20mg (Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were responders (achieved a 75% reduction in the Psoriasis Area Severity Index [PASI-75]) continued to receive 20 mg apremilast BID during the 12-week extension phase (Weeks 12-24).
1118047|NCT00521339|E1|Reported Event|Apremilast 20 mg (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
1118048|NCT00521144|B6|Baseline|Total|Total of all reporting groups
1118049|NCT00521144|B5|Baseline|Phase II Obatoclax Mesylate + Topotecan in SCLC|Obatoclax Mesylate 14 + 14 mg/m2 and Topotecan 1.25 mg/m2
1118050|NCT00521144|B4|Baseline|Phase I Obatoclax Mesylate + Topotecan in Solid Tumors Level 4|Level 4: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 + 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
1118051|NCT00521144|B3|Baseline|Phase I Obatoclax Mesylate + Topotecan in Solid Tumors Level 3|Level 3: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 + 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
1118052|NCT00521144|B2|Baseline|Phase I Obatoclax Mesylate + Topotecan in Solid Tumors Level 2|Level 2: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
1118053|NCT00521144|B1|Baseline|Phase I Obatoclax Mesylate + Topotecan in Solid Tumors Level 1|Level 1: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
1118054|NCT00521144|P5|Participant Flow|Phase II Obatoclax Mesylate + Topotecan in SCLC|Obatoclax Mesylate 14 + 14 mg/m2 and Topotecan 1.25 mg/m2
1118055|NCT00521144|P4|Participant Flow|Phase I; Level 4: Obatoclax Mesylate + Topotecan|Level 4: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 + 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
1118056|NCT00521144|P3|Participant Flow|Phase I; Level 3: Obatoclax Mesylate + Topetecan|Level 3: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 + 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
1118057|NCT00521144|P2|Participant Flow|Phase I; Level 2: Obatoclax Mesylate + Topetecan|Level 2: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
1118058|NCT00521144|P1|Participant Flow|Phase I; Level 1: Obatoclax Mesylate + Topetecan|Level 1: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
1118059|NCT00521144|O5|Outcome|Phase II Obatoclax Mesylate + Topotecan in SCLC|Obatoclax Mesylate 14 + 14 mg/m2 and Topotecan 1.25 mg/m2
1128491|NCT00490945|O1|Outcome|Placebo|Randomized to Placebo
1118060|NCT00521144|O4|Outcome|Phase 1; Level 4: Obatoclax Mesylate + Topotecan|Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 + 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
1118061|NCT00521144|O3|Outcome|Phase I; Level 3: Obatoclax Mesylate + Topetecan|Level 3: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 + 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
1118062|NCT00521144|O2|Outcome|Phase I; Level 2: Obatoclax Mesylate + Topetecan|Level 2: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
1118063|NCT00521144|O1|Outcome|Phase I; Level 1: Obatoclax Mesylate + Topetecan|Level 1: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
1118064|NCT00521144|E5|Reported Event|Phase II Obatoclax Mesylate + Topotecan in SCLC|Obatoclax Mesylate 14 + 14 mg/m2 and Topotecan 1.25 mg/m2
1118065|NCT00521144|E4|Reported Event|Phase I; Level 4: Obatoclax Mesylate + Topotecan|Level 4: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 + 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
1118066|NCT00521144|E3|Reported Event|Phase I; Level 3: Obatoclax Mesylate + Topotecan|Level 3: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 + 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
1118067|NCT00521144|E2|Reported Event|Phase I; Level 2: Obatoclax Mesylate + Topotecan|Level 2: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
1118068|NCT00521144|E1|Reported Event|Phase I; Level 1: Obatoclax Mesylate + Topotecan|Level 1: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
1118069|NCT00521079|B3|Baseline|Total|Total of all reporting groups
1118070|NCT00521079|B2|Baseline|Placebo|Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).
1118071|NCT00521079|B1|Baseline|vBloc|Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
1118072|NCT00521079|P2|Participant Flow|Placebo|Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).
1118073|NCT00521079|P1|Participant Flow|vBloc|Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
1118074|NCT00521079|O2|Outcome|Placebo|Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).
1118075|NCT00521079|O1|Outcome|vBloc|Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
1118076|NCT00521079|O2|Outcome|Placebo|Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).
1118077|NCT00521079|O1|Outcome|vBloc|Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
1118078|NCT00521079|O2|Outcome|Placebo|Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).
1118079|NCT00521079|O1|Outcome|vBloc|Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
1118256|NCT00520572|O1|Outcome|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
1118082|NCT00521053|B1|Baseline|PV-10|PV-10 (10% rose bengal disodium): Intralesional injection for chemoablation.
1118083|NCT00521053|P1|Participant Flow|PV-10|PV-10 (10% rose bengal disodium): Intralesional injection for chemoablation. In the treatment phase, participants received a single IL injection of PV-10 into each of up to 20 study lesions on day 0 (i.e., one cycle). Treatment cycles could be repeated at weeks 8, 12 and 16 for new non-target lesions or existing target or non-target lesions not exhibiting complete response (i.e., complete disappearance). Participants were observed for 52 weeks. Radiologic assessments of visceral disease status were performed every 12 weeks throughout the study and patients were transitioned into survival follow-up if at any time the investigator identified clinical or radiologic evidence of distant progression. No other melanoma therapy was permitted during the study interval.
1118084|NCT00521053|O2|Outcome|Stage IV|Participants reporting Stage IV disease at baseline
1118085|NCT00521053|O1|Outcome|Stage III|Participants reporting Stage III disease at baseline
1118086|NCT00521053|O1|Outcome|All Lesions Treated|
1118087|NCT00521053|O2|Outcome|Stage IV|Participants reporting Stage IV disease at baseline
1118088|NCT00521053|O1|Outcome|Stage III|Participants reporting Stage III disease at baseline
1118089|NCT00521053|O1|Outcome|PV-10|PV-10 (10% rose bengal disodium): Intralesional injection for chemoablation.
1118090|NCT00521053|O1|Outcome|PV-10|PV-10 (10% rose bengal disodium): Intralesional injection for chemoablation.
1118091|NCT00521053|E1|Reported Event|PV-10|PV-10 (10% rose bengal disodium): Intralesional injection for chemoablation.
1118092|NCT00521014|B1|Baseline|Relapsed Follicular Lymphoma Patients|Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma
1118093|NCT00521014|P1|Participant Flow|Relapsed Follicular Lymphoma Patients|Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma GM-CSF: 250 mcg (flat dose) three times per week for 8 weeks, Rituximab: 375 mg/m2/week for 4 weeks, beginning within 3 days after the first dose of GM-CSF
1118094|NCT00521014|O1|Outcome|Relapsed Follicular Lymphoma Patients|Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma
1118095|NCT00521014|E1|Reported Event|Relapsed Follicular Lymphoma Patients|Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma
1118096|NCT00521001|B1|Baseline|Everolimus + Temozolomide|Patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, 22-26, and 29-33 and 200 mg/m^2 temozolomide orally once a day on days 8-12 for cycle 1 only (where cycle length is 35 days). For cycle 2 and all subsequent cycles, patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, and 22-26 and 200 mg/m^2 temozolomide orally once a day on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1118222|NCT00520676|O2|Outcome|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
1118980|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
1118097|NCT00521001|P1|Participant Flow|Everolimus + Temozolomide|Patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, 22-26, and 29-33 and 200 mg/m^2 temozolomide orally once a day on days 8-12 for cycle 1 only (where cycle length is 35 days). For cycle 2 and all subsequent cycles, patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, and 22-26 and 200 mg/m^2 temozolomide orally once a day on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1118098|NCT00521001|O1|Outcome|Everolimus + Temozolomide|Patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, 22-26, and 29-33 and 200 mg/m^2 temozolomide orally once a day on days 8-12 for cycle 1 only (where cycle length is 35 days). For cycle 2 and all subsequent cycles, patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, and 22-26 and 200 mg/m^2 temozolomide orally once a day on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1118099|NCT00521001|O1|Outcome|Everolimus + Temozolomide|Patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, 22-26, and 29-33 and 200 mg/m^2 temozolomide orally once a day on days 8-12 for cycle 1 only (where cycle length is 35 days). For cycle 2 and all subsequent cycles, patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, and 22-26 and 200 mg/m^2 temozolomide orally once a day on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1118100|NCT00521001|O1|Outcome|Everolimus + Temozolomide|Patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, 22-26, and 29-33 and 200 mg/m^2 temozolomide orally once a day on days 8-12 for cycle 1 only (where cycle length is 35 days). For cycle 2 and all subsequent cycles, patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, and 22-26 and 200 mg/m^2 temozolomide orally once a day on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1118101|NCT00521001|O1|Outcome|Everolimus + Temozolomide|Patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, 22-26, and 29-33 and 200 mg/m^2 temozolomide orally once a day on days 8-12 for cycle 1 only (where cycle length is 35 days). For cycle 2 and all subsequent cycles, patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, and 22-26 and 200 mg/m^2 temozolomide orally once a day on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1118102|NCT00521001|E1|Reported Event|Everolimus + Temozolomide|Patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, 22-26, and 29-33 and 200 mg/m^2 temozolomide orally once a day on days 8-12 for cycle 1 only (where cycle length is 35 days). For cycle 2 and all subsequent cycles, patients receive 10 mg everolimus orally once a day on days 1-5, 8-12, 15-19, and 22-26 and 200 mg/m^2 temozolomide orally once a day on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1118103|NCT00520975|B3|Baseline|Total|Total of all reporting groups
1118144|NCT00520936|P3|Participant Flow|Rhabdomyosarcoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1118145|NCT00520936|P2|Participant Flow|Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1118146|NCT00520936|P1|Participant Flow|Osteosarcoma|Pemetrexed 1910 milligrams per meters squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old)
1118147|NCT00520936|O8|Outcome|Non-Brainstem High-Grade Glioma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1118104|NCT00520975|B2|Baseline|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
1118105|NCT00520975|B1|Baseline|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
1118106|NCT00520975|P2|Participant Flow|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
1118107|NCT00520975|P1|Participant Flow|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
1118108|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
1118172|NCT00520845|B1|Baseline|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib~celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.~Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle~pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.~laboratory biomarker analysis: Blood collection"
1128492|NCT00490945|O5|Outcome|100 mg VEC-162|Randomized to 100 mg VEC-162
1118109|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
1118110|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
1118111|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
1118112|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
1118148|NCT00520936|O7|Outcome|Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1118149|NCT00520936|O6|Outcome|Ependymoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1126264|NCT00498485|B2|Baseline|Xyrem|Xyrem: Same as for Placebo
1118113|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
1118114|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
1118115|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
1118116|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
1118117|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
1118118|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
1118223|NCT00520676|O1|Outcome|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
1118119|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
1118120|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
1118121|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
1118122|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
1118123|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
1118124|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
1118125|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
1118126|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
1118127|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
1118128|NCT00520975|E2|Reported Event|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
1118224|NCT00520676|E2|Reported Event|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
1118129|NCT00520975|E1|Reported Event|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
1118130|NCT00520936|B9|Baseline|Total|Total of all reporting groups
1118131|NCT00520936|B8|Baseline|Non-Brainstem High-Grade Glioma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1118132|NCT00520936|B7|Baseline|Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1118133|NCT00520936|B6|Baseline|Ependymoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1118134|NCT00520936|B5|Baseline|Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1118135|NCT00520936|B4|Baseline|Neuroblastoma (Measureable Disease)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1118136|NCT00520936|B3|Baseline|Rhabdomyosarcoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1118137|NCT00520936|B2|Baseline|Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1118138|NCT00520936|B1|Baseline|Osteosarcoma|Pemetrexed 1910 milligrams per meters squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old)
1118139|NCT00520936|P8|Participant Flow|Non-Brainstem High-Grade Glioma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1118140|NCT00520936|P7|Participant Flow|Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1118141|NCT00520936|P6|Participant Flow|Ependymoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1118142|NCT00520936|P5|Participant Flow|Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1118143|NCT00520936|P4|Participant Flow|Neuroblastoma (Measureable Disease)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1129781|NCT00488033|B3|Baseline|Total|Total of all reporting groups
1118150|NCT00520936|O5|Outcome|Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1118151|NCT00520936|O4|Outcome|Neuroblastoma (Measureable Disease)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1118152|NCT00520936|O3|Outcome|Rhabdomyosarcoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1118153|NCT00520936|O2|Outcome|Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1118154|NCT00520936|O1|Outcome|Osteosarcoma|Pemetrexed 1910 milligrams per meters squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old)
1118155|NCT00520936|O8|Outcome|Non-Brainstem High-Grade Glioma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1118156|NCT00520936|O7|Outcome|Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1118157|NCT00520936|O6|Outcome|Ependymoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1118158|NCT00520936|O5|Outcome|Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1118159|NCT00520936|O4|Outcome|Neuroblastoma (Measureable Disease)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1118160|NCT00520936|O3|Outcome|Rhabdomyosarcoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1118161|NCT00520936|O2|Outcome|Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1118162|NCT00520936|O1|Outcome|Osteosarcoma|Pemetrexed 1910 milligrams per meters squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old)
1118163|NCT00520936|O8|Outcome|Non-Brainstem High-Grade Glioma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1118164|NCT00520936|O7|Outcome|Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1118165|NCT00520936|O6|Outcome|Ependymoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1118166|NCT00520936|O5|Outcome|Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1118167|NCT00520936|O4|Outcome|Neuroblastoma (Measureable Disease)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1118168|NCT00520936|O3|Outcome|Rhabdomyosarcoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1118169|NCT00520936|O2|Outcome|Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
1118170|NCT00520936|O1|Outcome|Osteosarcoma|Pemetrexed 1910 milligrams per meters squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old)
1118171|NCT00520936|E1|Reported Event|Pemetrexed|Pemetrexed 1910 mg/m2 (or 60 mg/kg if patient <12 months old)
1118190|NCT00520741|O1|Outcome|Lacosamide 300 mg/Day|"Lacosamide (LCM) 300 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
1118173|NCT00520845|P1|Participant Flow|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib~celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.~Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle~pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.~laboratory biomarker analysis: Blood collection"
1118174|NCT00520845|O1|Outcome|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib~celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.~Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle~pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.~laboratory biomarker analysis: Blood collection"
1118175|NCT00520845|O1|Outcome|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib~celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.~Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle~pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.~laboratory biomarker analysis: Blood collection"
1118176|NCT00520845|O1|Outcome|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib~celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.~Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle~pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.~laboratory biomarker analysis: Blood collection"
1118177|NCT00520845|O1|Outcome|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib~celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.~Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle~pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.~laboratory biomarker analysis: Blood collection"
1118178|NCT00520845|O1|Outcome|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib~celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.~Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle~pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.~laboratory biomarker analysis: Blood collection"
1118179|NCT00520845|E1|Reported Event|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib~celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.~Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle~pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.~laboratory biomarker analysis: Blood collection"
1118250|NCT00520572|O1|Outcome|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
1118251|NCT00520572|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
1118252|NCT00520572|O5|Outcome|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
1118180|NCT00520767|B1|Baseline|Melphalan, Dexamethasone, Bortezomib,|"Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4~bortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22~dexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23~melphalan: Melphalan 9 mg/m2/day days 1-4~microarray analysis: ≤28 days prior to enrollment~flow cytometry: Day 1 of cycles 6, 12, 18 and at end of study.~laboratory biomarker analysis: ≤28 days prior to enrollment~quality-of-life assessment: Start of each cycle"
1118181|NCT00520767|P1|Participant Flow|Melphalan, Dexamethasone, Bortezomib,|"Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4~bortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22~dexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23~melphalan: Melphalan 9 mg/m2/day days 1-4~microarray analysis: ≤28 days prior to enrollment~flow cytometry: Day 1 of cycles 6, 12, 18 and at end of study.~laboratory biomarker analysis: ≤28 days prior to enrollment~quality-of-life assessment: Start of each cycle"
1118182|NCT00520767|O1|Outcome|Melphalan, Dexamethasone, Bortezomib,|"Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4~bortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22~dexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23~melphalan: Melphalan 9 mg/m2/day days 1-4~microarray analysis: ≤28 days prior to enrollment~flow cytometry: Day 1 of cycles 6, 12, 18 and at end of study.~laboratory biomarker analysis: ≤28 days prior to enrollment~quality-of-life assessment: Start of each cycle"
1118183|NCT00520767|E1|Reported Event|Melphalan, Dexamethasone, Bortezomib,|"Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4~bortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22~dexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23~melphalan: Melphalan 9 mg/m2/day days 1-4~microarray analysis: ≤28 days prior to enrollment~flow cytometry: Day 1 of cycles 6, 12, 18 and at end of study.~laboratory biomarker analysis: ≤28 days prior to enrollment~quality-of-life assessment: Start of each cycle"
1118184|NCT00520741|B3|Baseline|Total|Total of all reporting groups
1118185|NCT00520741|B2|Baseline|Lacosamide 400 mg/Day|"Lacosamide 400 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
1118186|NCT00520741|B1|Baseline|Lacosamide 300 mg/Day|"Lacosamide 300 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
1118187|NCT00520741|P2|Participant Flow|Lacosamide 400 mg/Day|"Lacosamide 400 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
1118188|NCT00520741|P1|Participant Flow|Lacosamide 300 mg/Day|"Lacosamide 300 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
1118189|NCT00520741|O2|Outcome|Lacosamide 400 mg/Day|"Lacosamide (LCM) 400 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
1118191|NCT00520741|O2|Outcome|Lacosamide 400 mg/Day|"Lacosamide (LCM) 400 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
1118192|NCT00520741|O1|Outcome|Lacosamide 300 mg/Day|"Lacosamide (LCM) 300 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
1118193|NCT00520741|O2|Outcome|Lacosamide 400 mg/Day|"Lacosamide (LCM) 400 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
1118194|NCT00520741|O1|Outcome|Lacosamide 300 mg/Day|"Lacosamide (LCM) 300 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
1118195|NCT00520741|O2|Outcome|Lacosamide 400 mg/Day|"Lacosamide (LCM) 400 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.~This study had a single inferential test of the primary efficacy variable for the LCM 400 mg/day treatment arm which was to be compared to an external historical control. As such, no adjustment for multiplicity was required. Additional analyses of the primary efficacy variable for the LCM 400 mg/day and LCM 300mg/day treatment arms was for exploratory or supportive purposes only. The analysis of the LCM 300 mg/day arm is exploratory due to the 3 :1 randomization ratio. Therefore the LCM 300 mg/day arm is not reported for this Outcome Measure."
1118196|NCT00520741|O1|Outcome|Lacosamide 300 mg/Day|"Lacosamide (LCM) 300 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
1118197|NCT00520741|O2|Outcome|Lacosamide 400 mg/Day|"Lacosamide (LCM) 400 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
1118198|NCT00520741|O1|Outcome|Lacosamide 300 mg/Day|"Lacosamide (LCM) 300 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
1118253|NCT00520572|O4|Outcome|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
1118254|NCT00520572|O3|Outcome|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
1118199|NCT00520741|O2|Outcome|Lacosamide 400 mg/Day|"Lacosamide (LCM) 400 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.~This study had a single inferential test of the primary efficacy variable for the LCM 400 mg/day treatment arm which was to be compared to an external historical control. As such, no adjustment for multiplicity was required. Additional analyses of the primary efficacy variable for the LCM 400 mg/day and LCM 300 mg/day treatment arms was for exploratory or supportive purposes only. The analysis of the LCM 300 mg/day arm is exploratory due to the 3:1 randomization ratio. Therefore the LCM 300 mg/day arm is not reported for this Outcome Measure."
1118200|NCT00520741|O1|Outcome|Lacosamide 300 mg/Day|"Lacosamide (LCM) 300 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
1118201|NCT00520741|E2|Reported Event|Lacosamide 400 mg/Day|"Lacosamide 400 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
1118202|NCT00520741|E1|Reported Event|Lacosamide 300 mg/Day|"Lacosamide 300 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
1118203|NCT00520676|B3|Baseline|Total|Total of all reporting groups
1118204|NCT00520676|B2|Baseline|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
1118205|NCT00520676|B1|Baseline|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
1118206|NCT00520676|P2|Participant Flow|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
1118207|NCT00520676|P1|Participant Flow|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
1118208|NCT00520676|O2|Outcome|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
1118209|NCT00520676|O1|Outcome|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
1118210|NCT00520676|O2|Outcome|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
1118211|NCT00520676|O1|Outcome|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
1118212|NCT00520676|O2|Outcome|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
1118213|NCT00520676|O1|Outcome|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
1118214|NCT00520676|O2|Outcome|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
1118215|NCT00520676|O1|Outcome|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
1118216|NCT00520676|O2|Outcome|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
1118217|NCT00520676|O1|Outcome|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
1118218|NCT00520676|O2|Outcome|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
1118219|NCT00520676|O1|Outcome|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
1128493|NCT00490945|O4|Outcome|50 mg VEC-162|Randomized to 50 mg VEC-162
1118225|NCT00520676|E1|Reported Event|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
1118226|NCT00520572|B7|Baseline|Total|Total of all reporting groups
1118227|NCT00520572|B6|Baseline|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
1118228|NCT00520572|B5|Baseline|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
1118229|NCT00520572|B4|Baseline|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
1118230|NCT00520572|B3|Baseline|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
1118231|NCT00520572|B2|Baseline|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
1118232|NCT00520572|B1|Baseline|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
1118233|NCT00520572|P6|Participant Flow|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
1118234|NCT00520572|P5|Participant Flow|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
1118235|NCT00520572|P4|Participant Flow|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
1118236|NCT00520572|P3|Participant Flow|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
1118237|NCT00520572|P2|Participant Flow|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
1118238|NCT00520572|P1|Participant Flow|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
1118239|NCT00520572|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
1118240|NCT00520572|O5|Outcome|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
1118241|NCT00520572|O4|Outcome|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
1118242|NCT00520572|O3|Outcome|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
1118243|NCT00520572|O2|Outcome|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
1118244|NCT00520572|O1|Outcome|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
1118245|NCT00520572|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
1118246|NCT00520572|O5|Outcome|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
1118247|NCT00520572|O4|Outcome|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
1118248|NCT00520572|O3|Outcome|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
1118249|NCT00520572|O2|Outcome|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
1131359|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
1118257|NCT00520572|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
1118258|NCT00520572|O5|Outcome|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
1118259|NCT00520572|O4|Outcome|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
1118260|NCT00520572|O3|Outcome|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
1118261|NCT00520572|O2|Outcome|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
1118262|NCT00520572|O1|Outcome|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
1118263|NCT00520572|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
1118264|NCT00520572|O5|Outcome|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
1118265|NCT00520572|O4|Outcome|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
1118266|NCT00520572|O3|Outcome|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
1118267|NCT00520572|O2|Outcome|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
1118268|NCT00520572|O1|Outcome|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
1118269|NCT00520572|E6|Reported Event|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
1118270|NCT00520572|E5|Reported Event|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
1118271|NCT00520572|E4|Reported Event|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
1118272|NCT00520572|E3|Reported Event|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
1118273|NCT00520572|E2|Reported Event|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
1118274|NCT00520572|E1|Reported Event|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
1118275|NCT00520546|B1|Baseline|FEC-PET/eMRI|The day before surgery, fasting patients received a bladder catheter right before Positron-Emission-Tomography/ Magnetic Resonance Imaging (PET/MRI) examination to avoid different sizes of the urinary bladder in PET and MRI scan and to reduce bladder FEC-activity overlay of the prostate. After applying the endorectal MRI coil patients were positioned in a vacuum mattress on MRI table. Additionally, 4 PET/MRI multimodality spot markers containing 37kBq [22Na] and a MRI T2w (T2 weighed) hyperintense gel were attached at the hip region to allow landmark PET/MRI fusion. After MRI acquisition the modular MRI table was fixed on the PET table system. Patients kept in the same position during the whole procedure. PET scans were performed by using a multiphase protocol starting with a list mode emission scan immediately after the administration of 3.3MBq [18F]fluoroethylcholine (FEC) as a bolus through the cubital vein.
1118314|NCT00519779|O2|Outcome|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
1118315|NCT00519779|O1|Outcome|Placebo|Placebo oral Omega-3 fish oil supplementation
1118981|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
1118276|NCT00520546|P1|Participant Flow|FEC-PET/eMRI|The day before surgery, fasting patients received a bladder catheter right before Positron-Emission-Tomography/ Magnetic Resonance Imaging (PET/MRI) examination to avoid different sizes of the urinary bladder in PET and MRI scan and to reduce bladder FEC-activity overlay of the prostate. After applying the endorectal MRI coil patients were positioned in a vacuum mattress on MRI table. Additionally, 4 PET/MRI multimodality spot markers containing 37kBq [22Na] and a MRI T2w (T2 weighed) hyperintense gel were attached at the hip region to allow landmark PET/MRI fusion. After MRI acquisition the modular MRI table was fixed on the PET table system. Patients kept in the same position during the whole procedure. PET scans were performed by using a multiphase protocol starting with a list mode emission scan immediately after the administration of 3.3MBq [18F]fluoroethylcholine (FEC) as a bolus through the cubital vein.
1118277|NCT00520546|O3|Outcome|PET/MRI|PET images at 45 min p.i. and 65 min p.i. (post injection) were fused with transversal endorectal and QBody T2w MRI images by using Hermes Medical Solutions Multi Modality landmark fusion tool. The four PET/MRI spot markers served as references. Without any patient movement between both modalities the fused images fitted exactly.
1118278|NCT00520546|O2|Outcome|Magnetic Resonance Imaging (MRI)|The MRI examination was performed on a 1.5Tesla MRI system (Gyroscan ACS-NT, Philips, Hamburg, Germany) with combined QBody and endorectal coil. Pelvic assessment and lymph node staging was effected with 5mm T2w TSE transversal and a coronal STIR sequence. For prostate assessment, 3mm endorectal T2w SE sagittal, transversal and coronal sequences were acquired. Transversal sequences were angulated 90° to intraprostatic bladder catheter to allow exact correlation with histological holoptical slices.
1118279|NCT00520546|O1|Outcome|FEC-PET|"PET scans were performed on a LSO scanner (ECAT ACCEL, Siemens, Erlangen, Germany) by using a multiphase protocol starting with a cold transmission scan of the lower pelvis. This was followed by a list mode emission scan with 10 frames à 1 minute starting immediately after the administration of 3.3MBq [18F]Fluoroethylcholine chloride (FEC; Eckert & Ziegler EURO-PET Berlin GmbH) as a bolus through the cubital vein. Acquisition parameters were 3 minutes emission scan and 2 minutes transmission scan for each bed position. Therefore the prostate region was scanned again at 45 minutes p.i. (post injection) A delayed local acquisition at 65 minutes over the lower pelvis with 6 minutes emission and 2 minutes transmission finished the diagnostic acquisition procedure."
1118280|NCT00520546|O3|Outcome|PET/MRI|PET images at 45 min p.i. and 65 min p.i. (post injection) were fused with transversal endorectal and QBody T2w MRI images by using Hermes Medical Solutions Multi Modality landmark fusion tool. The four PET/MRI spot markers served as references. Without any patient movement between both modalities the fused images fitted exactly.
1118281|NCT00520546|O2|Outcome|Magnetic Resonance Imaging (MRI)|The MRI examination was performed on a 1.5Tesla MRI system (Gyroscan ACS-NT, Philips, Hamburg, Germany) with combined QBody and endorectal coil. Pelvic assessment and lymph node staging was effected with 5mm T2w TSE transversal and a coronal STIR sequence. For prostate assessment, 3mm endorectal T2w SE sagittal, transversal and coronal sequences were acquired. Transversal sequences were angulated 90° to intraprostatic bladder catheter to allow exact correlation with histological holoptical slices.
1118333|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
1118424|NCT00520234|O1|Outcome|Prophylaxis|Caspofungin 50 mg IV daily up to 28 days of therapy
1118282|NCT00520546|O1|Outcome|FEC-PET|"PET scans were performed on a LSO scanner (ECAT ACCEL, Siemens, Erlangen, Germany) by using a multiphase protocol starting with a cold transmission scan of the lower pelvis. This was followed by a list mode emission scan with 10 frames à 1 minute starting immediately after the administration of 3.3MBq [18F]Fluoroethylcholine chloride (FEC; Eckert & Ziegler EURO-PET Berlin GmbH) as a bolus through the cubital vein. Acquisition parameters were 3 minutes emission scan and 2 minutes transmission scan for each bed position. Therefore the prostate region was scanned again at 45 minutes p.i. (post injection) A delayed local acquisition at 65 minutes over the lower pelvis with 6 minutes emission and 2 minutes transmission finished the diagnostic acquisition procedure."
1118283|NCT00520546|O3|Outcome|PET/MRI|PET images at 45 min p.i. and 65 min p.i. (post injection) were fused with transversal endorectal and QBody T2w MRI images by using Hermes Medical Solutions Multi Modality landmark fusion tool. The four PET/MRI spot markers served as references. Without any patient movement between both modalities the fused images fitted exactly.
1118284|NCT00520546|O2|Outcome|Magnetic Resonance Imaging (MRI)|The MRI examination was performed on a 1.5Tesla MRI system (Gyroscan ACS-NT, Philips, Hamburg, Germany) with combined QBody and endorectal coil. Pelvic assessment and lymph node staging was effected with 5mm T2w TSE transversal and a coronal STIR sequence. For prostate assessment, 3mm endorectal T2w SE sagittal, transversal and coronal sequences were acquired. Transversal sequences were angulated 90° to intraprostatic bladder catheter to allow exact correlation with histological holoptical slices.
1118285|NCT00520546|O1|Outcome|FEC-PET|"PET scans were performed on a LSO scanner (ECAT ACCEL, Siemens, Erlangen, Germany) by using a multiphase protocol starting with a cold transmission scan of the lower pelvis. This was followed by a list mode emission scan with 10 frames à 1 minute starting immediately after the administration of 3.3MBq [18F]Fluoroethylcholine chloride (FEC; Eckert & Ziegler EURO-PET Berlin GmbH) as a bolus through the cubital vein. Acquisition parameters were 3 minutes emission scan and 2 minutes transmission scan for each bed position. Therefore the prostate region was scanned again at 45 minutes p.i. (post injection) A delayed local acquisition at 65 minutes over the lower pelvis with 6 minutes emission and 2 minutes transmission finished the diagnostic acquisition procedure."
1118286|NCT00520546|O3|Outcome|PositronEmissionTomography/MagneticResonanceImaging (PET/MRI)|PET images at 45 min p.i. (post injection) and 65 min p.i. were fused with transversal endorectal and QBody T2 weighed (T2w) MRI images by using Hermes Medical Solutions Multi Modality landmark fusion tool. The four PET/MRI spot markers served as references. Without any patient movement between both modalities the fused images fitted exactly.
1118287|NCT00520546|O2|Outcome|Magnetic Resonance Imaging (MRI)|The MRI examination was performed on a 1.5Tesla MRI system (Gyroscan ACS-NT, Philips, Hamburg, Germany) with combined QBody and endorectal coil. Pelvic assessment and lymph node staging was effected with 5mm T2 weighted (T2w) turbo spin echo (TSE) transversal and a coronal short-tau inversion recovery (STIR) sequence. For prostate assessment, 3mm endorectal T2 weighed (T2w) spin echo (SE) sagittal, transversal and coronal sequences were acquired. Transversal sequences were angulated 90° to intraprostatic bladder catheter to allow exact correlation with histological holoptical slices.
1118316|NCT00519779|O2|Outcome|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
1118317|NCT00519779|O1|Outcome|Placebo|Placebo oral Omega-3 fish oil supplementation
1128494|NCT00490945|O3|Outcome|20 mg VEC-162|Randomized to 20 mg VEC-162
1118288|NCT00520546|O1|Outcome|[18F]Fluoroethylcholine Positron-Emission-Tomography (FEC-PET)|"PET scans were performed on a LSO scanner (ECAT ACCEL, Siemens, Erlangen, Germany) by using a multiphase protocol starting with a cold transmission scan of the lower pelvis. This was followed by a list mode emission scan with 10 frames à 1 minute starting immediately after the administration of 3.3MBq [18F]Fluoroethylcholine chloride (FEC; Eckert & Ziegler EURO-PET Berlin GmbH) as a bolus through the cubital vein. Acquisition parameters were 3 minutes emission scan and 2 minutes transmission scan for each bed position. Therefore the prostate region was scanned again at 45 minutes p.i. (post injection) A delayed local acquisition at 65 minutes over the lower pelvis with 6 minutes emission and 2 minutes transmission finished the diagnostic acquisition procedure."
1118289|NCT00520546|E1|Reported Event|FEC-PET/eMRI|The day before surgery, fasting patients received a bladder catheter right before Positron-Emission-Tomography/ Magnetic Resonance Imaging (PET/MRI) examination to avoid different sizes of the urinary bladder in PET and MRI scan and to reduce bladder FEC-activity overlay of the prostate. After applying the endorectal MRI coil patients were positioned in a vacuum mattress on MRI table. Additionally, 4 PET/MRI multimodality spot markers containing 37kBq [22Na] and a MRI T2w (T2 weighed) hyperintense gel were attached at the hip region to allow landmark PET/MRI fusion. After MRI acquisition the modular MRI table was fixed on the PET table system. Patients kept in the same position during the whole procedure. PET scans were performed by using a multiphase protocol starting with a list mode emission scan immediately after the administration of 3.3MBq [18F]fluoroethylcholine (FEC) as a bolus through the cubital vein.
1118290|NCT00519831|B1|Baseline|Vinflunine + Cetuximab|"Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator.~cetuximab: 400 mg/m² week 1,then 250 mg/m² weekly~vinflunine: Vinflunine 320 mg/m² every 21 days"
1118291|NCT00519831|P1|Participant Flow|Vinflunine + Cetuximab|"Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator.~cetuximab: 400 mg/m² week 1,then 250 mg/m² weekly~vinflunine: Vinflunine 320 mg/m² every 21 days"
1118292|NCT00519831|O1|Outcome|Vinflunine + Cetuximab|"Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator.~cetuximab: 400 mg/m² week 1,then 250 mg/m² weekly~vinflunine: Vinflunine 320 mg/m² every 21 days"
1118334|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
1118425|NCT00520234|O2|Outcome|Placebo|Normal Saline 100 cc IV daily
1118293|NCT00519831|O1|Outcome|Vinflunine + Cetuximab|"Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator.~cetuximab: 400 mg/m² week 1,then 250 mg/m² weekly~vinflunine: Vinflunine 320 mg/m² every 21 days"
1118294|NCT00519831|O1|Outcome|Vinflunine + Cetuximab|"Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator.~cetuximab: 400 mg/m² week 1,then 250 mg/m² weekly~vinflunine: Vinflunine 320 mg/m² every 21 days"
1118295|NCT00519831|O1|Outcome|Vinflunine + Cetuximab|"Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator.~cetuximab: 400 mg/m² week 1,then 250 mg/m² weekly~vinflunine: Vinflunine 320 mg/m² every 21 days"
1118296|NCT00519831|E1|Reported Event|Vinflunine + Cetuximab|"Patients may receive more than 4 cycles of therapy if they continue to demonstrate response to therapy, have limited toxicity, and if the treating physician determines that they are deriving clinical benefit from the treatment. The decision of continuing therapy beyond 4 cycles must be discussed with the principal investigator.~cetuximab: 400 mg/m² week 1,then 250 mg/m² weekly~vinflunine: Vinflunine 320 mg/m² every 21 days"
1118297|NCT00519818|B1|Baseline|Cortef Then Chronocort|Hydrocortisone immediate release 3 times daily total dose 30mg for 7 days, then hydrocortisone modified release tablet 30mg once nightly for 28days
1118298|NCT00519818|P1|Participant Flow|Cortef Then Chronocort|Hydrocortisone immediate release tablet treatment then Modified release hydrocortisone
1118299|NCT00519818|O2|Outcome|Chronocort|Hydrocortisone modified release tablet treatment
1118300|NCT00519818|O1|Outcome|Cortef|Hydrocortisone immediate release tablet
1118301|NCT00519818|O2|Outcome|Chronocort|Hydrocortisone modified release tablet treatment
1118302|NCT00519818|O1|Outcome|Cortef|Hydrocortisone immediate release tablet
1118303|NCT00519818|E2|Reported Event|Cortef|Hydrocortisone immediate release tablet
1118304|NCT00519818|E1|Reported Event|Chronocort|Hydrocortisone modified release tablet
1118305|NCT00519779|B3|Baseline|Total|Total of all reporting groups
1118306|NCT00519779|B2|Baseline|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
1118307|NCT00519779|B1|Baseline|Placebo|Placebo oral Omega-3 fish oil supplementation
1118308|NCT00519779|P2|Participant Flow|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
1118309|NCT00519779|P1|Participant Flow|Placebo|Placebo oral Omega-3 fish oil supplementation
1118310|NCT00519779|O2|Outcome|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
1118311|NCT00519779|O1|Outcome|Placebo|Placebo oral Omega-3 fish oil supplementation
1118312|NCT00519779|O2|Outcome|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
1118313|NCT00519779|O1|Outcome|Placebo|Placebo oral Omega-3 fish oil supplementation
1118318|NCT00519779|O2|Outcome|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
1118319|NCT00519779|O1|Outcome|Placebo|Placebo oral Omega-3 fish oil supplementation
1118320|NCT00519779|O2|Outcome|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
1118321|NCT00519779|O1|Outcome|Placebo|Placebo oral Omega-3 fish oil supplementation
1118322|NCT00519779|E2|Reported Event|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
1118323|NCT00519779|E1|Reported Event|Placebo|Placebo oral Omega-3 fish oil supplementation
1118324|NCT00520494|B1|Baseline|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
1118325|NCT00520494|P1|Participant Flow|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
1118326|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
1118327|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
1118328|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
1118329|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
1118330|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
1118331|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
1118332|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
1118335|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
1118336|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
1118337|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
1118338|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
1118339|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
1118340|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
1118341|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
1118342|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
1118343|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
1118344|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
1118345|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
1118346|NCT00520494|E1|Reported Event|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
1118347|NCT00520468|B1|Baseline|Cytokine-Immunotherapy|Erythropoietin 40,000 units subcutaneously (SQ) weekly; G-CSF 300 mcg SQ twice per week; Prednisone 60 mg/Day for 7 days, taper over 1 month; Cyclosporin A 300 mg orally daily
1118348|NCT00520468|P1|Participant Flow|Cytokine-Immunotherapy|Erythropoietin 40,000 units subcutaneously (SQ) weekly; G-CSF 300 mcg SQ twice per week; Prednisone 60 mg/Day for 7 days, taper over 1 month; Cyclosporin A 300 mg orally daily
1118349|NCT00520468|O1|Outcome|Cytokine-Immunotherapy|Erythropoietin 40,000 units subcutaneously (SQ) weekly; G-CSF 300 mcg SQ twice per week; Prednisone 60 mg/Day for 7 days, taper over 1 month; Cyclosporin A 300 mg orally daily
1118350|NCT00520468|E1|Reported Event|Cytokine-Immunotherapy|Erythropoietin 40,000 units subcutaneously (SQ) weekly; G-CSF 300 mcg SQ twice per week; Prednisone 60 mg/Day for 7 days, taper over 1 month; Cyclosporin A 300 mg orally daily
1118351|NCT00520403|B1|Baseline|Bevacizumab + IFN/Vinblastine|"Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).~Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.~If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression."
1118352|NCT00520403|P1|Participant Flow|Bevacizumab + Interferon Alfa-2a (IFN)/Vinblastine|"Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg intravenously (IV) and bevacizumab 15 milligrams per kilogram (mg/kg) IV on Day 1 followed by 2 weeks off and IFN subcutaneous (SC) injection three times per week (starting on Day 1) at doses of 3 million International Units (mIU) (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).~Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3; the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.~If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression."
1118353|NCT00520403|O1|Outcome|Bevacizumab + IFN/Vinblastine|"Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).~Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.~If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression."
1118354|NCT00520403|O1|Outcome|Bevacizumab + IFN/Vinblastine|"Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).~Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.~If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression."
1118355|NCT00520403|O1|Outcome|Bevacizumab + IFN/Vinblastine|"Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).~Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.~If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression."
1118356|NCT00520403|O1|Outcome|Bevacizumab + IFN/Vinblastine|"Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).~Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.~If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression."
1118357|NCT00520403|E1|Reported Event|Bevacizumab + IFN/Vinblastine|"Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).~Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.~If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression."
1118358|NCT00520351|B3|Baseline|Total|Total of all reporting groups
1118359|NCT00520351|B2|Baseline|Optifree Replenish First, Then ClearCare|In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
1118360|NCT00520351|B1|Baseline|ClearCare First, Then Optifree Replenish|In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
1118361|NCT00520351|P2|Participant Flow|Optifree Replenish First, Then ClearCare|In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
1118398|NCT00520299|O3|Outcome|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects enrolled to receive 160 IU/m^2/week of ADI-PEG 20
1118362|NCT00520351|P1|Participant Flow|ClearCare First, Then Optifree Replenish|In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
1118363|NCT00520351|O2|Outcome|Optifree Replenish First, Then ClearCare|In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
1118364|NCT00520351|O1|Outcome|ClearCare First, Then Optifree Replenish|In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
1118365|NCT00520351|O2|Outcome|Optifree Replenish First, Then ClearCare|In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
1118366|NCT00520351|O1|Outcome|ClearCare First, Then Optifree Replenish|In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
1118367|NCT00520351|O2|Outcome|Optifree Replenish First, Then ClearCare|In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
1118368|NCT00520351|O1|Outcome|ClearCare First, Then Optifree Replenish|In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
1118369|NCT00520351|O2|Outcome|Optifree Replenish First, Then ClearCare|In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
1118370|NCT00520351|O1|Outcome|ClearCare First, Then Optifree Replenish|In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
1118371|NCT00520351|E2|Reported Event|Optifree Replenish First, Then ClearCare|In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
1118421|NCT00520234|P2|Participant Flow|Placebo|Normal Saline 100 cc IV daily
1118422|NCT00520234|P1|Participant Flow|Prophylaxis|Caspofungin 50 mg IV daily up to 28 days of therapy
1118372|NCT00520351|E1|Reported Event|ClearCare First, Then Optifree Replenish|In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
1118373|NCT00520299|B4|Baseline|Total|Total of all reporting groups
1118374|NCT00520299|B3|Baseline|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects enrolled to receive 160 IU/m^2/week of ADI-PEG 20
1118375|NCT00520299|B2|Baseline|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects enrolled to receive 80 IU/m^2/week of ADI-PEG 20
1118376|NCT00520299|B1|Baseline|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects enrolled to receive 40 IU/m^2/week of ADI-PEG 20
1118377|NCT00520299|P3|Participant Flow|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects enrolled to receive 160 IU/m^2/week of ADI-PEG 20
1118378|NCT00520299|P2|Participant Flow|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects enrolled to receive 80 IU/m^2/week of ADI-PEG 20
1118379|NCT00520299|P1|Participant Flow|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects enrolled to receive 40 IU/m^2/week of ADI-PEG 20
1118380|NCT00520299|O3|Outcome|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects enrolled to receive 160 IU/m^2/week of ADI-PEG 20
1118381|NCT00520299|O2|Outcome|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects enrolled to receive 80 IU/m^2/week of ADI-PEG 20
1118382|NCT00520299|O1|Outcome|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects enrolled to receive 40 IU/m^2/week of ADI-PEG 20
1118383|NCT00520299|O3|Outcome|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects enrolled to receive 160 IU/m^2/week of ADI-PEG 20
1118384|NCT00520299|O2|Outcome|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects enrolled to receive 80 IU/m^2/week of ADI-PEG 20
1118385|NCT00520299|O1|Outcome|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects enrolled to receive 40 IU/m^2/week of ADI-PEG 20
1118386|NCT00520299|O3|Outcome|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects enrolled to receive 160 IU/m^2/week of ADI-PEG 20
1118387|NCT00520299|O2|Outcome|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects enrolled to receive 80 IU/m^2/week of ADI-PEG 20
1118388|NCT00520299|O1|Outcome|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects enrolled to receive 40 IU/m^2/week of ADI-PEG 20
1118389|NCT00520299|O3|Outcome|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects enrolled to receive 160 IU/m^2/week of ADI-PEG 20
1118390|NCT00520299|O2|Outcome|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects enrolled to receive 80 IU/m^2/week of ADI-PEG 20
1118391|NCT00520299|O1|Outcome|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects enrolled to receive 40 IU/m^2/week of ADI-PEG 20
1118392|NCT00520299|O3|Outcome|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects enrolled to receive 160 IU/m^2/week of ADI-PEG 20
1118393|NCT00520299|O2|Outcome|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects enrolled to receive 80 IU/m^2/week of ADI-PEG 20
1118394|NCT00520299|O1|Outcome|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects enrolled to receive 40 IU/m^2/week of ADI-PEG 20
1118395|NCT00520299|O3|Outcome|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects enrolled to receive 160 IU/m^2/week of ADI-PEG 20
1118396|NCT00520299|O2|Outcome|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects enrolled to receive 80 IU/m^2/week of ADI-PEG 20
1118397|NCT00520299|O1|Outcome|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects enrolled to receive 40 IU/m^2/week of ADI-PEG 20
1118399|NCT00520299|O2|Outcome|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects enrolled to receive 80 IU/m^2/week of ADI-PEG 20
1118400|NCT00520299|O1|Outcome|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects enrolled to receive 40 IU/m^2/week of ADI-PEG 20
1118401|NCT00520299|O3|Outcome|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects enrolled to receive 160 IU/m^2/week of ADI-PEG 20
1118402|NCT00520299|O2|Outcome|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects enrolled to receive 80 IU/m^2/week of ADI-PEG 20
1118403|NCT00520299|O1|Outcome|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects enrolled to receive 40 IU/m^2/week of ADI-PEG 20
1118404|NCT00520299|E3|Reported Event|Cohort 3: ADI-PEG 20 160 IU/m^2/Week|Includes subjects who received 160 IU/m^2/week of ADI-PEG 20
1118405|NCT00520299|E2|Reported Event|Cohort 2: ADI-PEG 20 80 IU/m^2/Week|Includes subjects who received 80 IU/m^2/week of ADI-PEG 20
1118406|NCT00520299|E1|Reported Event|Cohort 1: ADI-PEG 20 40 IU/m^2/Week|Includes subjects who received 40 IU/m^2/week of ADI-PEG 20
1118407|NCT00520286|B3|Baseline|Total|Total of all reporting groups
1118408|NCT00520286|B2|Baseline|Placebo|"Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks~Placebo: Placebo / daily"
1118409|NCT00520286|B1|Baseline|Modafinil|"Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks~Modafinil: 200 mg or 400 mg /daily"
1118410|NCT00520286|P2|Participant Flow|Placebo|"Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks~Placebo: Placebo / daily"
1118411|NCT00520286|P1|Participant Flow|Modafinil|"Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks~Modafinil: 200 mg or 400 mg /daily"
1118412|NCT00520286|O2|Outcome|Placebo|"Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks~Placebo: Placebo / daily"
1118413|NCT00520286|O1|Outcome|Modafinil|"Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks~Modafinil: 200 mg or 400 mg /daily"
1118414|NCT00520286|O2|Outcome|Placebo|"Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks~Placebo: Placebo / daily"
1118415|NCT00520286|O1|Outcome|Modafinil|"Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks~Modafinil: 200 mg or 400 mg /daily"
1118416|NCT00520286|E2|Reported Event|Placebo|"Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks~Placebo: Placebo / daily"
1118417|NCT00520286|E1|Reported Event|Modafinil|"Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks~Modafinil: 200 mg or 400 mg /daily"
1118418|NCT00520234|B3|Baseline|Total|Total of all reporting groups
1118419|NCT00520234|B2|Baseline|Placebo|Normal Saline 100 cc IV daily
1118420|NCT00520234|B1|Baseline|Prophylaxis|Caspofungin 50 mg IV daily up to 28 days of therapy
1118426|NCT00520234|O1|Outcome|Prophylaxis|Caspofungin 50 mg IV daily up to 28 days of therapy
1118427|NCT00520234|O2|Outcome|Placebo|Normal Saline 100 cc IV daily
1118428|NCT00520234|O1|Outcome|Prophylaxis|Caspofungin 50mg IV daily
1118429|NCT00520234|E2|Reported Event|Placebo|Normal Saline 100 cc IV daily
1118430|NCT00520234|E1|Reported Event|Prophylaxis|Caspofungin 50 mg IV daily up to 28 days of therapy
1118431|NCT00520013|B4|Baseline|Total|Total of all reporting groups
1118432|NCT00520013|B3|Baseline|Carboplatin/Paclitaxel/Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation: None~bevacizumab~paclitaxel~carboplatin"
1118433|NCT00520013|B2|Baseline|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year.~bevacizumab~erlotinib~paclitaxel~carboplatin"
1118434|NCT00520013|B1|Baseline|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year.~bevacizumab~paclitaxel~carboplatin"
1118435|NCT00520013|P3|Participant Flow|Carboplatin/Paclitaxel/Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation: None"
1118436|NCT00520013|P2|Participant Flow|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year."
1118460|NCT00519649|E1|Reported Event|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
1118461|NCT00519636|B5|Baseline|Total|Total of all reporting groups
1118982|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
1118437|NCT00520013|P1|Participant Flow|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year."
1118438|NCT00520013|O2|Outcome|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year."
1118439|NCT00520013|O1|Outcome|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year."
1118440|NCT00520013|O2|Outcome|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year."
1118441|NCT00520013|O1|Outcome|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year."
1118442|NCT00520013|O2|Outcome|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year."
1118443|NCT00520013|O1|Outcome|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year."
1118528|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118444|NCT00520013|E2|Reported Event|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year."
1118445|NCT00520013|E1|Reported Event|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year."
1118446|NCT00519896|B1|Baseline|Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy)|"Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO"
1118447|NCT00519896|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy)|"Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO"
1118448|NCT00519896|O1|Outcome|Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy)|"Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO"
1118449|NCT00519896|O1|Outcome|Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy)|"Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO"
1118450|NCT00519896|O1|Outcome|Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy)|"Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO"
1118451|NCT00519896|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy, Antiangiogenesis Therapy)|"Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO"
1118452|NCT00519649|B1|Baseline|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
1118453|NCT00519649|P1|Participant Flow|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
1118454|NCT00519649|O1|Outcome|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
1118455|NCT00519649|O1|Outcome|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
1118456|NCT00519649|O1|Outcome|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
1118457|NCT00519649|O1|Outcome|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
1118458|NCT00519649|O1|Outcome|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
1118459|NCT00519649|O1|Outcome|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
1118462|NCT00519636|B4|Baseline|Placebo FP/FF|Subjects who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
1118463|NCT00519636|B3|Baseline|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
1118464|NCT00519636|B2|Baseline|Placebo FF/FP|Subject who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
1118465|NCT00519636|B1|Baseline|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
1118466|NCT00519636|P4|Participant Flow|Placebo FP/FF|Subjects who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
1118467|NCT00519636|P3|Participant Flow|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
1118468|NCT00519636|P2|Participant Flow|Placebo FF/FP|Subject who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
1118469|NCT00519636|P1|Participant Flow|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
1118470|NCT00519636|O3|Outcome|Total|All Subjects on both arms preference.
1118471|NCT00519636|O2|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
1118472|NCT00519636|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
1118473|NCT00519636|O3|Outcome|Total|All Subjects on both arms preference.
1118474|NCT00519636|O2|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
1118631|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118475|NCT00519636|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
1118476|NCT00519636|O3|Outcome|Total|All subjects on both arms preference.
1118477|NCT00519636|O2|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
1118478|NCT00519636|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
1118479|NCT00519636|O4|Outcome|Placebo FP/FF|Subjects who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
1118480|NCT00519636|O3|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
1118481|NCT00519636|O2|Outcome|Placebo FF/FP|Subjects who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
1118482|NCT00519636|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
1118483|NCT00519636|O4|Outcome|Placebo FP/FF|Subjects who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
1118484|NCT00519636|O3|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
1118485|NCT00519636|O2|Outcome|Placebo FF/FP|Subjects who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
1118486|NCT00519636|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
1118487|NCT00519636|O3|Outcome|Total|All subjects on both arms preference.
1118488|NCT00519636|O2|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
1128495|NCT00490945|O2|Outcome|10 mg VEC-162|Randomized to 10 mg VEC-162**
1118489|NCT00519636|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
1118490|NCT00519636|O4|Outcome|Placebo FP/FF|Subjects who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
1118491|NCT00519636|O3|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
1118492|NCT00519636|O2|Outcome|Placebo FF/FP|Subject who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
1118493|NCT00519636|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
1118494|NCT00519636|E4|Reported Event|Placebo -FP|Subject who took no active drug but believed they were on Fluticasone Propionate Nasal Spray.
1118495|NCT00519636|E3|Reported Event|Placebo - FF|Subjects who took no active drug but believed they were on Fluticasone Furoate Nasal Spray.
1118496|NCT00519636|E2|Reported Event|Fluticasone Propionate Nasal Spray|Subjects who receive Fluticasone Propionate Nasal Spray.
1118497|NCT00519636|E1|Reported Event|Fluticasone Furoate Nasal Spray|Subjects who received Fluticasone Furoate.
1118498|NCT00519623|B1|Baseline|Transdermal Patch|PassPort(r) Transdermal Insulin Delivery System
1118499|NCT00519623|P1|Participant Flow|Transdermal Patch|PassPort(r) Transdermal Insulin Delivery System
1118500|NCT00519623|O1|Outcome|Transdermal Patch|PassPort(r) Transdermal Insulin Delivery System
1118501|NCT00519623|O1|Outcome|Transdermal Patch|PassPort(r) Transdermal Insulin Delivery System
1118502|NCT00519623|E1|Reported Event|Transdermal Patch|PassPort(r) Transdermal Insulin Delivery System
1118503|NCT00519532|B1|Baseline|Rotigotine|Rotigotine Transdermal Patch
1118504|NCT00519532|P1|Participant Flow|Rotigotine|Rotigotine Transdermal Patch
1118505|NCT00519532|O1|Outcome|Rotigotine|Rotigotine Transdermal Patch
1118506|NCT00519532|O1|Outcome|Rotigotine|Rotigotine Transdermal Patch
1118507|NCT00519532|O1|Outcome|Rotigotine|Rotigotine Transdermal Patch
1118508|NCT00519532|O1|Outcome|Rotigotine|Rotigotine Transdermal Patch
1118509|NCT00519532|E1|Reported Event|Rotigotine|Rotigotine Transdermal Patch
1119013|NCT00517634|B1|Baseline|Overall Study Population|Overall Study Population: participants in all three treatment periods
1131380|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
1118510|NCT00519376|B1|Baseline|GW642444M(25,50 and 100 µg),GW642444H(100 µg), PB in 1-16 Seq|Participants were administered single dose of four of the five following treatments: GW642444M (25, 50 and 100 µg), GW642444H (100 µg) or placebo. Each participant received doses of GW642444M in an ascending dose manner with GW642444H and placebo randomly interspersed as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118511|NCT00519376|P16|Participant Flow|Seq 16: GW642444H 100 µg, GW642444M 25 µg, GW642444M 50 µg, PB|Participants were administered single dose of the following treatments: GW642444H 100 µg, GW642444M 25µg, GW642444M 50 µg, Placebo. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118512|NCT00519376|P15|Participant Flow|Seq 15: GW642444H 100 µg, GW642444M 25 µg, PB, GW642444M 50 µg|Participants were administered single dose of the following treatments: GW642444H 100 µg, GW642444M 25 µg, Placebo, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118513|NCT00519376|P14|Participant Flow|Seq 14: GW642444H 100 µg, PB, GW642444M 25 µg, GW642444M 50 µg|Participants were administered single dose of the following treatments: GW642444H 100 µg, Placebo, GW642444M 25 µg, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118514|NCT00519376|P13|Participant Flow|Seq 13: GW642444M 25 µg, GW642444H 100 µg, GW642444M 50 µg, PB|Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444H 100 µg, GW642444M 50 µg, Placebo. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118515|NCT00519376|P12|Participant Flow|Seq 12: GW642444M 25 µg, GW642444H 100 µg, PB, GW642444M 50 µg|Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444H 100 µg, Placebo, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118516|NCT00519376|P11|Participant Flow|Seq 11: PB, GW642444H 100 µg, GW642444M 25 µg, GW642444M 50 µg|Participants were administered single dose of the following treatments: Placebo, GW642444H 100 µg, GW642444M 25 µg, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118517|NCT00519376|P10|Participant Flow|Seq 10: GW642444M 25 µg, GW642444M 50 µg, GW642444H 100 µg, PB|Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444M 50 µg, GW642444H 100 µg, Placebo. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118518|NCT00519376|P9|Participant Flow|Seq 9: GW642444M 25 µg, PB, GW642444H 100 µg, GW642444M 50 µg|Participants were administered single dose of the following treatments: GW642444M 25 µg, Placebo, GW642444H 100 µg, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118519|NCT00519376|P8|Participant Flow|Seq 8: PB, GW642444M 25 µg, GW642444H 100 µg, GW642444M 50 µg|Participants were administered single dose of the following treatments: Placebo, GW642444M 25 µg, GW642444H 100 µg, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118520|NCT00519376|P7|Participant Flow|Seq 7: GW642444M 25 µg, GW642444M 50 µg, PB, GW642444H 100 µg|Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444M 50 µg, Placebo, GW642444H 100 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118521|NCT00519376|P6|Participant Flow|Seq 6: GW642444M 25 µg, PB, GW642444M 50 µg, GW642444H 100 µg|Participants were administered single dose of the following treatments: GW642444M 25 µg, Placebo, GW642444M 50 µg, GW642444H 100 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118522|NCT00519376|P5|Participant Flow|Seq 5: PB, GW642444M 25 µg, GW642444M 50 µg, GW642444H 100 µg|Participants were administered single dose of the following treatments: Placebo, GW642444M 25 µg, GW642444M 50 µg, GW642444H 100 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118523|NCT00519376|P4|Participant Flow|Seq 4: GW642444M 25 µg, GW642444M 50 µg, GW642444M 100 µg, PB|Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444M 50 µg, GW642444M 100 µg, Placebo. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118524|NCT00519376|P3|Participant Flow|Seq 3: GW642444M 25 µg, GW642444M 50 µg, PB, GW642444M 100 µg|Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444M 50 µg, Placebo, GW642444M 100 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118525|NCT00519376|P2|Participant Flow|Seq 2: GW642444M 25 µg, PB, GW642444M 50 µg, GW642444M 100 µg|Participants were administered single dose of the following treatments: GW642444M 25 µg, Placebo, GW642444M 50 µg, GW642444M 100 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118526|NCT00519376|P1|Participant Flow|Seq 1: PB, GW642444M 25 µg, GW642444M 50 µg, GW642444M 100 µg|Participants were administered single dose of the following treatments: Placebo (PB), GW642444M 25 µg, GW642444M 50 µg, GW642444M 100 µg. Each participants received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118527|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1119100|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
1118529|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118530|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118531|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118532|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118533|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118534|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118535|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118536|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118537|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118538|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118539|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118540|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118541|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118542|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118543|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118544|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118545|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118546|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118547|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118548|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118549|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118550|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118551|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118552|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118553|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118554|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118555|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118556|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118557|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118558|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118559|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118560|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118561|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118562|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1119848|NCT00517530|O2|Outcome|100/200 mg - Phase I, NHL|Obinutuzumab intravenous infusion
1118563|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118564|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118565|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118566|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118567|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118568|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118569|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118570|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118571|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118572|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118573|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118574|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118575|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118576|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118577|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118578|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118579|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118580|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118581|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118983|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
1118582|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118583|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118584|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118585|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118586|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118587|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118588|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118589|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118590|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118591|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118592|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118593|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118594|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118595|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118596|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118597|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118598|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118599|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118600|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118601|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118602|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118603|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118604|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118605|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118606|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118607|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118608|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118609|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118610|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118611|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118612|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118613|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118614|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118615|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1128496|NCT00490945|O1|Outcome|Placebo*|Randomized to Placebo
1118616|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118617|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118618|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118619|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118620|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118621|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118622|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118623|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118624|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118625|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118626|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118627|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118628|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118629|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118630|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118632|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118633|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118634|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118635|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118636|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118637|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118638|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118639|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118640|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118641|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118642|NCT00519376|E5|Reported Event|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118643|NCT00519376|E4|Reported Event|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118644|NCT00519376|E3|Reported Event|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118645|NCT00519376|E2|Reported Event|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118646|NCT00519376|E1|Reported Event|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
1118647|NCT00519285|B3|Baseline|Total|Total of all reporting groups
1118648|NCT00519285|B2|Baseline|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
1118649|NCT00519285|B1|Baseline|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
1118650|NCT00519285|P2|Participant Flow|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
1118651|NCT00519285|P1|Participant Flow|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
1118652|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
1118653|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
1118654|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
1118655|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
1118656|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
1118657|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
1118658|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
1118659|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
1118660|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
1118661|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
1118662|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
1118663|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
1118664|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
1118665|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
1131875|NCT00483184|E1|Reported Event|1|(placebo)0 IU IFN alpha
1118666|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
1118667|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
1118668|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
1118669|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
1118670|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
1118671|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
1118672|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
1118673|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
1118674|NCT00519285|E2|Reported Event|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
1118675|NCT00519285|E1|Reported Event|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
1118676|NCT00519194|B1|Baseline|Epicor Cardiac Ablation|"Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery~Surgical ablation of permanent AF: Concomitant AF ablation during mitral valve surgery"
1118677|NCT00519194|P1|Participant Flow|Epicor Cardiac Ablation|"Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery~Surgical ablation of permanent AF: Concomitant AF ablation during mitral,aortic, and or tricuspid valve surgery, PFO closure or CABG procedure"
1118678|NCT00519194|O1|Outcome|Epicor Cardiac Ablation|"Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery~Surgical ablation of permanent AF: Concomitant AF ablation during mitral valve surgery"
1118679|NCT00519194|E1|Reported Event|Epicor Cardiac Ablation|"Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery~Surgical ablation of permanent AF: Concomitant AF ablation during mitral valve surgery"
1118680|NCT00519090|B3|Baseline|Total|Total of all reporting groups
1118681|NCT00519090|B2|Baseline|Imatinib|Patients received 400 mg twice daily. Capsules were available in 100 mg and 400 mg formulations.
1118682|NCT00519090|B1|Baseline|Nilotinib (AMN107)|Patients received 400 mg twice daily, 2 x 200 mg capsules twice daily.
1118683|NCT00519090|P2|Participant Flow|Imatinib|Patients received 400 mg twice daily. Capsules were available in 100 mg and 400 mg formulations.
1118684|NCT00519090|P1|Participant Flow|Nilotinib (AMN107)|Patients received 400 mg twice daily, 2 x 200 mg capsules twice daily.
1118685|NCT00519090|O2|Outcome|Imatinib|Patients received 400 mg twice daily. Capsules were available in 100 mg and 400 mg formulations.
1118686|NCT00519090|O1|Outcome|Nilotinib (AMN107)|Patients received 400 mg twice daily, 2 x 200 mg capsules twice daily.
1118687|NCT00519090|O2|Outcome|Imatinib|Patients received 400 mg twice daily. Capsules were available in 100 mg and 400 mg formulations.
1118688|NCT00519090|O1|Outcome|Nilotinib (AMN107)|Patients received 400 mg twice daily, 2 x 200 mg capsules twice daily.
1118689|NCT00519090|E2|Reported Event|Imatinib|Patients received 400 mg twice daily. Capsules were available in 100 mg and 400 mg formulations.
1118690|NCT00519090|E1|Reported Event|Nilotinib (AMN107)|Patients received 400 mg twice daily, 2 x 200 mg capsules twice daily.
1118691|NCT00519077|B1|Baseline|Gefitinib|Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
1118692|NCT00519077|P1|Participant Flow|Gefitinib|Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
1118693|NCT00519077|O1|Outcome|Gefitinib|Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
1118694|NCT00519077|O1|Outcome|Gefitinib|Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
1118844|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118695|NCT00519077|E1|Reported Event|Gefitinib|Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
1118696|NCT00518986|B3|Baseline|Total|Total of all reporting groups
1118697|NCT00518986|B2|Baseline|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118698|NCT00518986|B1|Baseline|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118699|NCT00518986|P2|Participant Flow|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118700|NCT00518986|P1|Participant Flow|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118701|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118702|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118825|NCT00518882|B1|Baseline|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1128497|NCT00490945|O5|Outcome|100 mg VEC-162|Randomized to 100 mg VEC-162
1118703|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118704|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118705|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118706|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118707|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1131876|NCT00483119|B3|Baseline|Total|Total of all reporting groups
1118708|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118709|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118710|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118711|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118712|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118713|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118714|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118826|NCT00518882|P2|Participant Flow|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118984|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
1118985|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
1128498|NCT00490945|O4|Outcome|50 mg VEC-162|Randomized to 50 mg VEC-162
1118715|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118716|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118717|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118718|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118719|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118720|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118721|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118722|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118723|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118724|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118725|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118726|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118827|NCT00518882|P1|Participant Flow|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118986|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
1118987|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
1118727|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118728|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118729|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118730|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118731|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118732|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118733|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118734|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118735|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118736|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118737|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118738|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118828|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118988|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
1118989|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
1128499|NCT00490945|O3|Outcome|20 mg VEC-162|Randomized to 20 mg VEC-162
1118739|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118740|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118741|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118742|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118743|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118744|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118745|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118746|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118747|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118748|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118749|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118750|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118829|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118990|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
1118991|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
1118751|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118752|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118753|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118754|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118755|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118756|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118757|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118758|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118759|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118760|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118761|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118762|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118830|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118992|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
1118993|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
1128500|NCT00490945|O2|Outcome|10 mg VEC-162|Randomized to 10 mg VEC-162
1118763|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118764|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118765|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118766|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118767|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118768|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118769|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118770|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118771|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118772|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118773|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118774|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118831|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118994|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
1118995|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
1118775|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118776|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118777|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118778|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118779|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118780|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118781|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118782|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118783|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118784|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118785|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118786|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118832|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118996|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
1118997|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
1128501|NCT00490945|O1|Outcome|Placebo|Randomized to Placebo
1118787|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118788|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118789|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118790|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118791|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118792|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118793|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118794|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118795|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118796|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118797|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118798|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118833|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118998|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
1118999|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
1118799|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118800|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118801|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118802|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118803|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118804|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118805|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118806|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118807|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118808|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118809|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118810|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118834|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1119000|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
1119001|NCT00518713|E4|Reported Event|Placebo|tablets; orally; daily for 15-18 weeks
1128980|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
1118811|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118812|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118813|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118814|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118815|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118816|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118817|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118818|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118819|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118820|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118821|NCT00518986|E2|Reported Event|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
1118822|NCT00518986|E1|Reported Event|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
1118823|NCT00518882|B3|Baseline|Total|Total of all reporting groups
1118824|NCT00518882|B2|Baseline|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118970|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
1131103|NCT00485433|B5|Baseline|Total|Total of all reporting groups
1118835|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118836|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118837|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118838|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118839|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118840|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118841|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118842|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118843|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118845|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118846|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118847|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118848|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118849|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118850|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118851|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118852|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118853|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118854|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118855|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118856|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118857|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118971|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
1118972|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
1118858|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118859|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118860|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118861|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118862|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118863|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118864|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118865|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118866|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118867|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118868|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118869|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118870|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118871|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118872|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118873|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118874|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118875|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118876|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118877|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118878|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118879|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118880|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118973|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
1118974|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
1118881|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118882|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118883|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118884|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118885|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118886|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118887|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118888|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118889|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118890|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118891|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118892|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118893|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118894|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118895|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118896|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118897|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118898|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118899|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118900|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118901|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118902|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118903|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118975|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
1118976|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
1118904|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118905|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118906|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118907|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118908|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118909|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118910|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118911|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118912|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118913|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118914|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118915|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118916|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118917|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118918|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118919|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118920|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118921|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118922|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118923|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118924|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118925|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118926|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118977|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
1118978|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
1118927|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118928|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118929|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118930|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118931|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118932|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118933|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118934|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118935|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118936|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118937|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118938|NCT00518882|E2|Reported Event|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118939|NCT00518882|E1|Reported Event|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
1118940|NCT00518713|B5|Baseline|Total|Total of all reporting groups
1118941|NCT00518713|B4|Baseline|Placebo|tablets; orally; daily for 15-18 weeks
1118942|NCT00518713|B3|Baseline|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
1118943|NCT00518713|B2|Baseline|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
1118944|NCT00518713|B1|Baseline|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
1118945|NCT00518713|P4|Participant Flow|Placebo|tablets; orally; daily for 15-18 weeks
1118946|NCT00518713|P3|Participant Flow|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
1118947|NCT00518713|P2|Participant Flow|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
1118948|NCT00518713|P1|Participant Flow|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
1118949|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
1118950|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
1118951|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
1118952|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
1118953|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
1118954|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
1118955|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
1118956|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
1118957|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
1118958|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
1118959|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
1118960|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
1118961|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
1118962|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
1118963|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
1118964|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
1118965|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
1118966|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
1118967|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
1118968|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
1118969|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
1119002|NCT00518713|E3|Reported Event|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
1119003|NCT00518713|E2|Reported Event|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
1119004|NCT00518713|E1|Reported Event|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
1119005|NCT00517699|B1|Baseline|Rituximab, Cytarabine, and MTX|Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
1119006|NCT00517699|P1|Participant Flow|Rituximab, Cytarabine, and Methotrexate (MTX)|Participants received single doses of rituximab 750 milligrams per square meter (mg/m^2) intravenously (IV) at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 grams per square meter (g/m^2) IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
1119007|NCT00517699|O1|Outcome|Rituximab, Cytarabine, and MTX|Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
1119008|NCT00517699|O1|Outcome|Rituximab, Cytarabine, and MTX|Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
1119009|NCT00517699|O1|Outcome|Rituximab, Cytarabine, and MTX|Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
1119010|NCT00517699|O1|Outcome|Rituximab, Cytarabine, and MTX|Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
1119011|NCT00517699|O1|Outcome|Rituximab, Cytarabine, and MTX|Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
1119012|NCT00517699|E1|Reported Event|Rituximab, Cytarabine, and MTX|Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
1132351|NCT00480532|B5|Baseline|Total|Total of all reporting groups
1119014|NCT00517634|P6|Participant Flow|Sequence 6: Placebo, FP, SFC|Placebo in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period
1119015|NCT00517634|P5|Participant Flow|Sequence 5: FP, Placebo, SFC|Fluticasone Propionate 100 mcg BID in the first treatment period: Placebo in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period
1119016|NCT00517634|P4|Participant Flow|Sequence 4: SFC, Placebo, FP|Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the first treatment period: Placebo in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period
1119017|NCT00517634|P3|Participant Flow|Sequence 3: SFC, FP, Placebo|Salmeterol/Fluticasone Propionate 50/100 Combination mcg BID in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Placebo in the third treatment period
1119018|NCT00517634|P2|Participant Flow|Sequence 2: Placebo, SFC, FP|Placebo in the first treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period
1119019|NCT00517634|P1|Participant Flow|Sequence 1: FP, SFC, Placebo|Fluticasone Propionate (FP) 100 micrograms (mcg) twice daily (BID) in the first treatment period: Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID in the second treatment period: Placebo in the third treatment period
1119020|NCT00517634|O3|Outcome|SFC 50/100 mcg BID|Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID
1119021|NCT00517634|O2|Outcome|FP 100 mcg BID|Fluticasone Propionate (FP) 100 mcg BID
1119022|NCT00517634|O1|Outcome|Placebo|Placebo
1119023|NCT00517634|O3|Outcome|SFC 50/100 mcg BID|Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID
1119024|NCT00517634|O2|Outcome|FP 100 mcg BID|Fluticasone Propionate (FP) 100 mcg BID
1119025|NCT00517634|O1|Outcome|Placebo|Placebo
1119026|NCT00517634|E3|Reported Event|SFC 50/100 BID|Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID
1119027|NCT00517634|E2|Reported Event|FP 100 mcg BID|Fluticasone Propionate 100 mcg BID
1119028|NCT00517634|E1|Reported Event|Placebo|Placebo
1119029|NCT00518687|B3|Baseline|Total|Total of all reporting groups
1119030|NCT00518687|B2|Baseline|Placebo|Placebo : 0.5-ml single injection of matching placebo
1119031|NCT00518687|B1|Baseline|V710 60 µg|V710: 0.5-ml single injection of V710 (60 µg)
1119032|NCT00518687|P2|Participant Flow|Placebo|Placebo : 0.5-ml single injection of matching placebo
1119033|NCT00518687|P1|Participant Flow|V710 60 µg|V710: 0.5-ml single injection of V710 (60 µg)
1119034|NCT00518687|O2|Outcome|Placebo|Placebo : 0.5-ml single injection of matching placebo
1119035|NCT00518687|O1|Outcome|V710 60 µg|V710: 0.5-ml single injection of V710 (60 µg)
1119036|NCT00518687|O2|Outcome|Placebo|Placebo : 0.5-ml single injection of matching placebo
1119037|NCT00518687|O1|Outcome|V710 60 µg|V710: 0.5-ml single injection of V710 (60 µg)
1119038|NCT00518687|O2|Outcome|Placebo|Placebo : 0.5-ml single injection of matching placebo
1119039|NCT00518687|O1|Outcome|V710 60 µg|V710: 0.5-ml single injection of V710 (60 µg)
1119040|NCT00518687|O2|Outcome|Placebo|Placebo : 0.5-ml single injection of matching placebo
1119041|NCT00518687|O1|Outcome|V710 60 µg|V710: 0.5-ml single injection of V710 (60 µg)
1119042|NCT00518687|E2|Reported Event|Placebo|Placebo : 0.5-ml single injection of matching placebo
1119043|NCT00518687|E1|Reported Event|V710 (60 µg) Lyophilized|V710: 0.5-ml single injection of V710 (60 µg)
1119044|NCT00518622|B9|Baseline|Total|Total of all reporting groups
1119045|NCT00518622|B8|Baseline|Placebo|Patients received an oral dose of matching placebo twice a day 9 (b.i.d.) for 7 days and on the morning of Day 8.
1119046|NCT00518622|B7|Baseline|600 mg q.d. MK7009|Patients received an oral dose of 600 mg MK7009 in the morning (q.d.) and an oral dose of matching placebo in the evening for 7 days. Patients received 600 mg of MK7009 on the morning of Day 8.
1119047|NCT00518622|B6|Baseline|125 mg q.d. MK7009|"Patients received an oral dose of 125 mg MK7009 in the morning (once a day (q.d.)) and an oral dose of matching placebo in the evening for 7 days.~Patients received 125 mg of MK7009 on the morning of Day 8."
1119048|NCT00518622|B5|Baseline|700 mg b.i.d. MK7009|Patients received an oral dose of 700 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
1119049|NCT00518622|B4|Baseline|500 mg b.i.d. MK7009|Patients received an oral dose of 500 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
1119050|NCT00518622|B3|Baseline|250 mg b.i.d. MK7009|Patients received an oral dose of 250 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
1119051|NCT00518622|B2|Baseline|75 mg b.i.d. MK7009|Patients received an oral dose of 75mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
1119052|NCT00518622|B1|Baseline|25 mg b.i.d. MK7009|Patients received an oral dose of 25mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
1119053|NCT00518622|P8|Participant Flow|Placebo|Patients received an oral dose of matching placebo twice a day 9 (b.i.d.) for 7 days and on the morning of Day 8.
1119054|NCT00518622|P7|Participant Flow|600 mg q.d. MK7009|Patients received an oral dose of 600 mg MK7009 in the morning (q.d.) and an oral dose of matching placebo in the evening for 7 days. Patients received 600 mg of MK7009 on the morning of Day 8.
1119055|NCT00518622|P6|Participant Flow|125 mg q.d. MK7009|"Patients received an oral dose of 125 mg MK7009 in the morning (once a day (q.d.)) and an oral dose of matching placebo in the evening for 7 days.~Patients received 125 mg of MK7009 on the morning of Day 8."
1119056|NCT00518622|P5|Participant Flow|700 mg b.i.d. MK7009|Patients received an oral dose of 700 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
1119057|NCT00518622|P4|Participant Flow|500 mg b.i.d. MK7009|Patients received an oral dose of 500 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
1119058|NCT00518622|P3|Participant Flow|250 mg b.i.d. MK7009|Patients received an oral dose of 250 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
1119059|NCT00518622|P2|Participant Flow|75 mg b.i.d. MK7009|Patients received an oral dose of 75mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
1119849|NCT00517530|O1|Outcome|50/100 mg - Phase I, NHL|Obinutuzumab intravenous infusion
1119060|NCT00518622|P1|Participant Flow|25 mg b.i.d. MK7009|Patients received an oral dose of 25mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
1119061|NCT00518622|O8|Outcome|Placebo|Patients received an oral dose of matching placebo twice a day 9 (b.i.d.) for 7 days and on the morning of Day 8.
1119062|NCT00518622|O7|Outcome|600 mg q.d. MK7009|Patients received an oral dose of 600 mg MK7009 in the morning (q.d.) and an oral dose of matching placebo in the evening for 7 days. Patients received 600 mg of MK7009 on the morning of Day 8.
1119063|NCT00518622|O6|Outcome|125 mg q.d. MK7009|"Patients received an oral dose of 125 mg MK7009 in the morning (once a day (q.d.)) and an oral dose of matching placebo in the evening for 7 days.~Patients received 125 mg of MK7009 on the morning of Day 8."
1119064|NCT00518622|O5|Outcome|700 mg b.i.d. MK7009|Patients received an oral dose of 700 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
1119065|NCT00518622|O4|Outcome|500 mg b.i.d. MK7009|Patients received an oral dose of 500 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
1119066|NCT00518622|O3|Outcome|250 mg b.i.d. MK7009|Patients received an oral dose of 250 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
1119067|NCT00518622|O2|Outcome|75 mg b.i.d. MK7009|Patients received an oral dose of 75mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
1119068|NCT00518622|O1|Outcome|25 mg b.i.d. MK7009|Patients received an oral dose of 25mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
1119069|NCT00518622|O8|Outcome|Placebo|Patients received an oral dose of matching placebo twice a day 9 (b.i.d.) for 7 days and on the morning of Day 8.
1119070|NCT00518622|O7|Outcome|600 mg q.d. MK7009|Patients received an oral dose of 600 mg MK7009 in the morning (q.d.) and an oral dose of matching placebo in the evening for 7 days. Patients received 600 mg of MK7009 on the morning of Day 8.
1119071|NCT00518622|O6|Outcome|125 mg q.d. MK7009|"Patients received an oral dose of 125 mg MK7009 in the morning (once a day (q.d.)) and an oral dose of matching placebo in the evening for 7 days.~Patients received 125 mg of MK7009 on the morning of Day 8."
1119072|NCT00518622|O5|Outcome|700 mg b.i.d. MK7009|Patients received an oral dose of 700 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
1119073|NCT00518622|O4|Outcome|500 mg b.i.d. MK7009|Patients received an oral dose of 500 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
1119074|NCT00518622|O3|Outcome|250 mg b.i.d. MK7009|Patients received an oral dose of 250 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
1119075|NCT00518622|O2|Outcome|75 mg b.i.d. MK7009|Patients received an oral dose of 75mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
1119076|NCT00518622|O1|Outcome|25 mg b.i.d. MK7009|Patients received an oral dose of 25mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
1119077|NCT00518622|E8|Reported Event|Placebo|Patients received an oral dose of matching placebo twice a day 9 (b.i.d.) for 7 days and on the morning of Day 8.
1119078|NCT00518622|E7|Reported Event|600 mg q.d. MK7009|Patients received an oral dose of 600 mg MK7009 in the morning (q.d.) and an oral dose of matching placebo in the evening for 7 days. Patients received 600 mg of MK7009 on the morning of Day 8.
1119079|NCT00518622|E6|Reported Event|125 mg q.d. MK7009|"Patients received an oral dose of 125 mg MK7009 in the morning (once a day (q.d.)) and an oral dose of matching placebo in the evening for 7 days.~Patients received 125 mg of MK7009 on the morning of Day 8."
1119080|NCT00518622|E5|Reported Event|700 mg b.i.d. MK7009|Patients received an oral dose of 700 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
1119811|NCT00517530|O5|Outcome|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
1119081|NCT00518622|E4|Reported Event|500 mg b.i.d. MK7009|Patients received an oral dose of 500 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
1119082|NCT00518622|E3|Reported Event|250 mg b.i.d. MK7009|Patients received an oral dose of 250 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
1119083|NCT00518622|E2|Reported Event|75 mg b.i.d. MK7009|Patients received an oral dose of 75mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
1119084|NCT00518622|E1|Reported Event|25 mg b.i.d. MK7009|Patients received an oral dose of 25mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
1119085|NCT00518531|B3|Baseline|Total|Total of all reporting groups
1119086|NCT00518531|B2|Baseline|Denosumab in Period 1 Then Alendronate in Period 2|Denosumab 60 mg subcutaneously every 6 months for 1 year (treatment period 1) followed by Alendronate 70 mg orally once a week for 1 year (treatment period 2).
1119087|NCT00518531|B1|Baseline|Alendronate in Period 1 Then Denosumab in Period 2|Alendronate 70 mg orally once a week for 1 year (treatment period 1) followed by Denosumab 60 mg subcutaneously every 6 months for 1 year (treatment period 2).
1119088|NCT00518531|P2|Participant Flow|Denosumab in Period 1 Then Alendronate in Period 2|Denosumab 60 mg subcutaneously every 6 months for 1 year (treatment period 1) followed by Alendronate 70 mg orally once a week for 1 year (treatment period 2).
1119089|NCT00518531|P1|Participant Flow|Alendronate in Period 1 Then Denosumab in Period 2|Alendronate 70 mg orally once a week (QW) for 1 year (treatment period 1) followed by Denosumab 60 mg subcutaneously every 6 months for 1 year (treatment period 2).
1119090|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
1119091|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
1119092|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
1119093|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
1119094|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
1119095|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
1119096|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
1119097|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
1119098|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
1119099|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
1119101|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
1119102|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
1119103|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
1119104|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
1119105|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
1119106|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
1119107|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
1119108|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
1119109|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
1119110|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
1119111|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
1119112|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
1119113|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
1119114|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
1119115|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
1119116|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
1119117|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
1119118|NCT00518531|E4|Reported Event|Treatment Period 2: Denosumab|Participants who received alendronate 70 mg orally once a week in year 1 then received denosumab 60 mg subcutaneously every 6 months in year 2.
1119119|NCT00518531|E3|Reported Event|Treatment Period 2: Alendronate|Participants who received denosumab 60 mg subcutaneously every 6 months in year 1 then received alendronate 70 mg orally once a week in year 2.
1119120|NCT00518531|E2|Reported Event|Treatment Period 1: Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months in year 1.
1119121|NCT00518531|E1|Reported Event|Treatment Period 1: Alendronate|Participants received alendronate 70 mg orally once a week in year 1.
1119122|NCT00518336|B3|Baseline|Total|Total of all reporting groups
1119123|NCT00518336|B2|Baseline|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119124|NCT00518336|B1|Baseline|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119125|NCT00518336|P2|Participant Flow|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119812|NCT00517530|O4|Outcome|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
1119126|NCT00518336|P1|Participant Flow|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119127|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119128|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119129|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119130|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119131|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119132|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119133|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119134|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119638|NCT00518011|O1|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
1119135|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119136|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119137|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119138|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119139|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119140|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119141|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119142|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119143|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119144|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119145|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119146|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119306|NCT00518323|O2|Outcome|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
1119307|NCT00518323|O1|Outcome|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
1119147|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119148|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119149|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119150|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119151|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119152|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119153|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119154|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119155|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119156|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119157|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119158|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119159|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119160|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119161|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119162|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119163|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119164|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119165|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119166|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119167|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119308|NCT00518323|O4|Outcome|Placebo|
1119309|NCT00518323|O3|Outcome|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
1119168|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119169|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119170|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119171|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119172|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119173|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119174|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119175|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119176|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119177|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119178|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119179|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119180|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119181|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119182|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119183|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119184|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119185|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119186|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119187|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119188|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119310|NCT00518323|O2|Outcome|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
1119311|NCT00518323|O1|Outcome|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
1119189|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119190|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119191|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119192|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119193|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119194|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119195|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119196|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119197|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119198|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119199|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119200|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119201|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119202|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119203|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119204|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119205|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119206|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119207|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119208|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119209|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119312|NCT00518323|O4|Outcome|Placebo|
1119313|NCT00518323|O3|Outcome|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
1119210|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119211|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119212|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119213|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119214|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119215|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119216|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119217|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119218|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119219|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119220|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119221|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119222|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119223|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119224|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119225|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119226|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119227|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119228|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119229|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119230|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119314|NCT00518323|O2|Outcome|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
1119315|NCT00518323|O1|Outcome|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
1119231|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119232|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119233|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119234|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119235|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119236|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119237|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119238|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119239|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119240|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119241|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119242|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119243|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119244|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119245|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119246|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119247|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119248|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119249|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119250|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119251|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119316|NCT00518323|E4|Reported Event|Placebo|
1119317|NCT00518323|E3|Reported Event|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
1119252|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119253|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119254|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119255|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119256|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119257|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119258|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119259|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119260|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119261|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119262|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119263|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119264|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119265|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119266|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119267|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119268|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119269|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119270|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119271|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119272|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119318|NCT00518323|E2|Reported Event|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
1119319|NCT00518323|E1|Reported Event|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
1119273|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119274|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119275|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119276|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119277|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119278|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119279|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119280|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119281|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119282|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119283|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119284|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119285|NCT00518336|E2|Reported Event|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119286|NCT00518336|E1|Reported Event|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
1119287|NCT00518323|B5|Baseline|Total|Total of all reporting groups
1119288|NCT00518323|B4|Baseline|Placebo|
1119289|NCT00518323|B3|Baseline|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
1119290|NCT00518323|B2|Baseline|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
1119291|NCT00518323|B1|Baseline|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
1119292|NCT00518323|P4|Participant Flow|Placebo|
1119293|NCT00518323|P3|Participant Flow|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
1119294|NCT00518323|P2|Participant Flow|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
1119295|NCT00518323|P1|Participant Flow|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
1119296|NCT00518323|O4|Outcome|Placebo|
1119297|NCT00518323|O3|Outcome|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
1119298|NCT00518323|O2|Outcome|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
1119299|NCT00518323|O1|Outcome|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
1119300|NCT00518323|O4|Outcome|Placebo|
1119301|NCT00518323|O3|Outcome|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
1119302|NCT00518323|O2|Outcome|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
1119303|NCT00518323|O1|Outcome|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
1119304|NCT00518323|O4|Outcome|Placebo|
1119305|NCT00518323|O3|Outcome|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
1119320|NCT00518284|B5|Baseline|Total|Total of all reporting groups
1119321|NCT00518284|B4|Baseline|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
1119322|NCT00518284|B3|Baseline|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
1119323|NCT00518284|B2|Baseline|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
1119324|NCT00518284|B1|Baseline|Control|Following revascularization, participants did not receive any study drug treatment.
1119325|NCT00518284|P4|Participant Flow|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
1119326|NCT00518284|P3|Participant Flow|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
1119327|NCT00518284|P2|Participant Flow|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
1119328|NCT00518284|P1|Participant Flow|Control|Following revascularization, participants did not receive any study drug treatment.
1119329|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
1119330|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
1119331|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
1119332|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
1119333|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
1119334|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
1119335|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
1119336|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
1119337|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
1119338|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
1119339|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
1119340|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
1119341|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
1119342|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
1119343|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
1119344|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
1119345|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
1119346|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
1119347|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
1119348|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
1119349|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
1119350|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
1119351|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
1119352|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
1119813|NCT00517530|O3|Outcome|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
1119353|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
1119354|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
1119355|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
1119356|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
1119357|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
1119358|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
1119359|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
1119360|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
1119361|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
1119362|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
1119363|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
1119364|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
1119365|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
1119720|NCT00517829|B3|Baseline|Total|Total of all reporting groups
1119366|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
1119367|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
1119368|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
1119369|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
1119370|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
1119371|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
1119372|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
1119373|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
1119374|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
1119375|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
1119376|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
1119377|NCT00518284|E4|Reported Event|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
1119378|NCT00518284|E3|Reported Event|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
1119379|NCT00518284|E2|Reported Event|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
1119380|NCT00518284|E1|Reported Event|Control|Following revascularization, participants did not receive any study drug treatment.
1119381|NCT00518180|B4|Baseline|Total|Total of all reporting groups
1119382|NCT00518180|B3|Baseline|Tdap →MenACWY → HPV|Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
1119383|NCT00518180|B2|Baseline|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
1119384|NCT00518180|B1|Baseline|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
1119385|NCT00518180|P3|Participant Flow|Tdap →MenACWY → HPV|Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
1119386|NCT00518180|P2|Participant Flow|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
1119387|NCT00518180|P1|Participant Flow|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
1119388|NCT00518180|O3|Outcome|Tdap → MenACWY → HPV|Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of HPV at months 2, 4, and 8
1119389|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV at months 2, 4, and 8
1119390|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two vaccinations of the HPV vaccine at month 2 and 6.
1119391|NCT00518180|O3|Outcome|Tdap → MenACWY →HPV|Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
1119392|NCT00518180|O2|Outcome|MenACWY→Tdap → HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
1119393|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
1119394|NCT00518180|O3|Outcome|Tdap →MenACWY → HPV|Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
1119395|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
1119396|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
1119397|NCT00518180|O3|Outcome|Tdap → MenACWY→HPV|Tdap was administered at study month 0 followed by one injection of the MenACWY vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
1119398|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8
1119399|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
1119400|NCT00518180|O3|Outcome|Tdap → MenACWY→HPV|Tdap was administered at study month 0 followed by one injection of the MenACWY vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
1119401|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8
1119402|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
1119403|NCT00518180|O3|Outcome|Tdap → MenACWY→HPV|Tdap was administered at study month 0 followed by one injection of the MenACWY vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
1119404|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8
1119405|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
1119406|NCT00518180|O3|Outcome|Tdap → MenACWY→HPV|Tdap was administered at study month 0 followed by one injection of the MenACWY vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
1119407|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8
1119408|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
1119409|NCT00518180|O3|Outcome|Tdap → MenACWY→HPV|Tdap was administered at study month 0 followed by one injection of the MenACWY vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
1119410|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
1119411|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
1119412|NCT00518180|O2|Outcome|HPV Alone|The three injections of the HPV vaccine was administered at study months 2, 4, and 8. This arm is a recombination of the two arms listed in the Participant Flow.
1119413|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
1119414|NCT00518180|O2|Outcome|HPV Alone|Three injections of the HPV vaccine were administered at study months 2, 4, and 8. This arm is a recombination of the two arms listed in the Participant Flow.
1119415|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
1119416|NCT00518180|O3|Outcome|Tdap → MenACWY→HPV|Tdap was administered at study month 0 followed by one injection of the MenACWY vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
1119814|NCT00517530|O2|Outcome|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
1119417|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8
1119418|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
1119419|NCT00518180|O3|Outcome|Tdap →MenACWY → HPV|Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
1119420|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
1119421|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
1119422|NCT00518180|O3|Outcome|Tdap →MenACWY → HPV|Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
1119423|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
1119424|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
1119425|NCT00518180|E3|Reported Event|Tdap → MenACWY → HPV|Tdpa was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of HPV at months 2,4 and 8.
1119426|NCT00518180|E2|Reported Event|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdpa vaccine at month 1, followed by three injections of the HPV at months 2,4 and 8.
1119427|NCT00518180|E1|Reported Event|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two vaccinations of the HPV vaccine at month 2 and 6.
1119428|NCT00518115|B11|Baseline|Total|Total of all reporting groups
1119429|NCT00518115|B10|Baseline|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119845|NCT00517530|O5|Outcome|800/1200 mg - Phase I, NHL|Obinutuzumab intravenous infusion
1132904|NCT00479557|B8|Baseline|Total|Total of all reporting groups
1119430|NCT00518115|B9|Baseline|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119431|NCT00518115|B8|Baseline|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119432|NCT00518115|B7|Baseline|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119433|NCT00518115|B6|Baseline|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119434|NCT00518115|B5|Baseline|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119435|NCT00518115|B4|Baseline|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119436|NCT00518115|B3|Baseline|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119437|NCT00518115|B2|Baseline|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
1119438|NCT00518115|B1|Baseline|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119439|NCT00518115|P10|Participant Flow|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119440|NCT00518115|P9|Participant Flow|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119441|NCT00518115|P8|Participant Flow|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119442|NCT00518115|P7|Participant Flow|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119443|NCT00518115|P6|Participant Flow|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119815|NCT00517530|O1|Outcome|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
1119444|NCT00518115|P5|Participant Flow|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119445|NCT00518115|P4|Participant Flow|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119446|NCT00518115|P3|Participant Flow|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119447|NCT00518115|P2|Participant Flow|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
1119448|NCT00518115|P1|Participant Flow|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119449|NCT00518115|O1|Outcome|All Participants Receiving Any Dose of Albiglutide|Participants received one of the following doses of albiglutide: 4 mg weekly, 15 mg weekly, 30 mg weekly (administered as a subcutaneous injection for 16 weeks) ; 15 mg bi-weekly, 30 mg bi-weekly, 50 mg bi-weekly (alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks); 50 mg every 4 weeks, 100 mg every 4 weeks (administered as a subcutaneous injection for 16 weeks). Participants received subcutaneous injections alternating between the left and right sides of the body.
1119450|NCT00518115|O1|Outcome|All Participants Receiving Any Dose of Albiglutide|Participants received one of the following doses of albiglutide: 4 mg weekly, 15 mg weekly, 30 mg weekly (administered as a subcutaneous injection for 16 weeks) ; 15 mg bi-weekly, 30 mg bi-weekly, 50 mg bi-weekly (alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks); 50 mg every 4 weeks, 100 mg every 4 weeks (administered as a subcutaneous injection for 16 weeks). Participants received subcutaneous injections alternating between the left and right sides of the body.
1119472|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119451|NCT00518115|O1|Outcome|All Participants Receiving Any Dose of Albiglutide|Participants received one of the following doses of albiglutide: 4 mg weekly, 15 mg weekly, 30 mg weekly (administered as a subcutaneous injection for 16 weeks) ; 15 mg bi-weekly, 30 mg bi-weekly, 50 mg bi-weekly (alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks); 50 mg every 4 weeks, 100 mg every 4 weeks (administered as a subcutaneous injection for 16 weeks). Participants received subcutaneous injections alternating between the left and right sides of the body.
1119452|NCT00518115|O1|Outcome|All Participants Receiving Any Dose of Albiglutide|Participants received one of the following doses of albiglutide: 4 mg weekly, 15 mg weekly, 30 mg weekly (administered as a subcutaneous injection for 16 weeks) ; 15 mg bi-weekly, 30 mg bi-weekly, 50 mg bi-weekly (alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks); 50 mg every 4 weeks, 100 mg every 4 weeks (administered as a subcutaneous injection for 16 weeks). Participants received subcutaneous injections alternating between the left and right sides of the body.
1119453|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119454|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119455|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119456|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119457|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119458|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119459|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119460|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119461|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
1119462|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119463|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119488|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119464|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119465|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119466|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119467|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119468|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119469|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119470|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119471|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
1119636|NCT00518011|O1|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
1119473|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119474|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119475|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119476|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119477|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119478|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119479|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119480|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119481|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
1119482|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119483|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119484|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119485|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119486|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119487|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119816|NCT00517530|O3|Outcome|Phase II, CLL|Obinutuzumab intravenous infusion at 1000/1000 mg
1119489|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119490|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119491|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
1119492|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119493|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119494|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119495|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119496|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119497|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119498|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119499|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119500|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119501|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
1119502|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119503|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119504|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119505|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119506|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119507|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119508|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119509|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119510|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119511|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
1119512|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119817|NCT00517530|O2|Outcome|Phase II, aNHL|Obinutuzumab intravenous infusion at 400/400 mg and 1600/800 mg
1119513|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119514|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119515|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119516|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119517|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119518|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119519|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119520|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119521|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
1119522|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119523|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119524|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119525|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119526|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119527|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119528|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119529|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119530|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119531|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
1119532|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119533|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119534|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119535|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119536|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119818|NCT00517530|O1|Outcome|Phase II, iNHL|Obinutuzumab intravenous infusion at 400/400 mg and 1600/800 mg
1119537|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119538|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119539|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119540|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119541|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
1119542|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119543|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119544|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119545|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119846|NCT00517530|O4|Outcome|400/800 mg - Phase I, NHL|Obinutuzumab intravenous infusion
1119546|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119547|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119548|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119549|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119550|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119551|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
1119552|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119553|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119554|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119555|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119556|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119557|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119558|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119559|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119560|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119623|NCT00518011|P2|Participant Flow|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
1119561|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
1119562|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119563|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119564|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119565|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119566|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119567|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119568|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119637|NCT00518011|O2|Outcome|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
1119569|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119570|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119571|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
1119572|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119573|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119574|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119575|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119576|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119577|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119578|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119579|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119580|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119581|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
1119582|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119583|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119584|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119756|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
1119585|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119586|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119587|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119588|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119589|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119590|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119591|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
1119592|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119593|NCT00518115|E10|Reported Event|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119594|NCT00518115|E9|Reported Event|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119595|NCT00518115|E8|Reported Event|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119596|NCT00518115|E7|Reported Event|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119597|NCT00518115|E6|Reported Event|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119598|NCT00518115|E5|Reported Event|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119599|NCT00518115|E4|Reported Event|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119600|NCT00518115|E3|Reported Event|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119601|NCT00518115|E2|Reported Event|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
1119602|NCT00518115|E1|Reported Event|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
1119603|NCT00518089|B3|Baseline|Total|Total of all reporting groups
1119604|NCT00518089|B2|Baseline|Placebo Eye Drops|
1119605|NCT00518089|B1|Baseline|Gatifloxacin 0.5% Eye Drops|
1119606|NCT00518089|P2|Participant Flow|Placebo Eye Drops|
1119607|NCT00518089|P1|Participant Flow|Gatifloxacin 0.5% Eye Drops|
1119608|NCT00518089|O2|Outcome|Placebo Eye Drops|
1119609|NCT00518089|O1|Outcome|Gatifloxacin 0.5% Eye Drops|
1119610|NCT00518089|O2|Outcome|Placebo Eye Drops|
1119611|NCT00518089|O1|Outcome|Gatifloxacin 0.5% Eye Drops|
1119612|NCT00518089|O2|Outcome|Placebo Eye Drops|
1119613|NCT00518089|O1|Outcome|Gatifloxacin 0.5% Eye Drops|
1119614|NCT00518089|O2|Outcome|Placebo Eye Drops|
1119615|NCT00518089|O1|Outcome|Gatifloxacin 0.5% Eye Drops|
1119616|NCT00518089|O2|Outcome|Placebo Eye Drops|
1119617|NCT00518089|O1|Outcome|Gatifloxacin 0.5% Eye Drops|
1119618|NCT00518089|E2|Reported Event|Placebo Eye Drops|
1119619|NCT00518089|E1|Reported Event|Gatifloxacin 0.5% Eye Drops|
1119620|NCT00518011|B3|Baseline|Total|Total of all reporting groups
1119621|NCT00518011|B2|Baseline|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
1119622|NCT00518011|B1|Baseline|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
1119757|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
1119624|NCT00518011|P1|Participant Flow|Gemcitabine|Participants received Gemcitabine 1000 milligram per meter square (mg/m^2)/day, intravenously (IV) on Days 1, 8, 15 and every 4 weeks for 6 cycles
1119625|NCT00518011|O2|Outcome|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
1119626|NCT00518011|O1|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
1119627|NCT00518011|O2|Outcome|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
1119628|NCT00518011|O1|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
1119629|NCT00518011|O2|Outcome|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
1119630|NCT00518011|O1|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
1119631|NCT00518011|O2|Outcome|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
1119632|NCT00518011|O1|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
1119633|NCT00518011|O2|Outcome|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
1119634|NCT00518011|O1|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles.
1119635|NCT00518011|O2|Outcome|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
1133073|NCT00479336|O2|Outcome|OPC-41061 7.5 mg|7.5 mg, 1 tablet a day
1119639|NCT00518011|O2|Outcome|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
1119640|NCT00518011|O1|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
1119641|NCT00518011|E2|Reported Event|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
1119642|NCT00518011|E1|Reported Event|Gemcitabine|Participants received Gemcitabine (1000 mg/m^2/day), IV on Days 1, 8, 15 of each 4 week cycle for 6 cycles
1119643|NCT00517933|B3|Baseline|Total|Total of all reporting groups
1119644|NCT00517933|B2|Baseline|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
1119645|NCT00517933|B1|Baseline|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for 12 weeks
1119646|NCT00517933|P2|Participant Flow|Placebo / Sildenafil|20 mg oral placebo 3 times per day
1119647|NCT00517933|P1|Participant Flow|Sildenafil / Sildenafil|20 mg oral sildenafil 3 times per day
1119648|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
1119649|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
1119650|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
1119651|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
1119652|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
1119653|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
1119654|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
1119655|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
1119656|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
1119657|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
1119658|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
1119659|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
1119660|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
1119661|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
1119662|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
1119663|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
1119664|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
1119758|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
1119665|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
1119666|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
1119667|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
1119668|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
1119669|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
1119670|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
1119671|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
1119672|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
1119673|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
1119674|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
1119675|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
1119676|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
1119677|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
1119678|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
1119679|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
1119680|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
1119847|NCT00517530|O3|Outcome|200/400 mg - Phase I, NHL|Obinutuzumab intravenous infusion
1119681|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
1119682|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
1119683|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
1119684|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
1119685|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
1119686|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
1119687|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
1119688|NCT00517933|O2|Outcome|Placebo / Sildenafil|20 mg oral placebo 3 times per day
1119689|NCT00517933|O1|Outcome|Sildenafil / Sildenafil|20 mg oral sildenafil 3 times per day
1119690|NCT00517933|O2|Outcome|Placebo / Sildenafil|20 mg oral placebo 3 times per day
1119691|NCT00517933|O1|Outcome|Sildenafil / Sildenafil|20 mg oral sildenafil 3 times per day
1119692|NCT00517933|O2|Outcome|Placebo / Sildenafil|20 mg oral placebo 3 times per day
1119693|NCT00517933|O1|Outcome|Sildenafil / Sildenafil|20 mg oral sildenafil 3 times per day
1119694|NCT00517933|O2|Outcome|Placebo / Sildenafil|20 mg oral placebo 3 times per day
1119695|NCT00517933|O1|Outcome|Sildenafil / Sildenafil|20 mg oral sildenafil 3 times per day
1119696|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
1119697|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
1119698|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
1119699|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for 12 weeks
1119700|NCT00517933|O2|Outcome|Placebo / Sildenafil|20 mg oral placebo 3 times per day
1119701|NCT00517933|O1|Outcome|Sildenafil / Sildenafil|20 mg oral sildenafil 3 times per day
1119702|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
1119703|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
1119704|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
1119705|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
1119706|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
1119707|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
1119708|NCT00517933|E2|Reported Event|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
1119709|NCT00517933|E1|Reported Event|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for 12 weeks
1119759|NCT00517751|E1|Reported Event|X-STOP PEEK|In this arm, patients will undergo X-STOP PEEK surgery.
1132980|NCT00479466|O5|Outcome|MK0893 80 mg|
1119710|NCT00517881|B1|Baseline|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
1119711|NCT00517881|P1|Participant Flow|C.E.R.A.|Participants received subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 micrograms (mcg) every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
1119712|NCT00517881|O1|Outcome|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
1119713|NCT00517881|O1|Outcome|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
1119714|NCT00517881|O1|Outcome|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
1119715|NCT00517881|O1|Outcome|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
1119716|NCT00517881|O1|Outcome|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
1119717|NCT00517881|O1|Outcome|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
1119718|NCT00517881|O1|Outcome|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
1119719|NCT00517881|E1|Reported Event|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
1119721|NCT00517829|B2|Baseline|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
1119722|NCT00517829|B1|Baseline|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
1119723|NCT00517829|P2|Participant Flow|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
1119724|NCT00517829|P1|Participant Flow|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
1119725|NCT00517829|O2|Outcome|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
1119726|NCT00517829|O1|Outcome|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
1119727|NCT00517829|O2|Outcome|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
1119728|NCT00517829|O1|Outcome|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
1119729|NCT00517829|O2|Outcome|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
1119730|NCT00517829|O1|Outcome|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
1119731|NCT00517829|O2|Outcome|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
1119732|NCT00517829|O1|Outcome|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
1119733|NCT00517829|O2|Outcome|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
1119734|NCT00517829|O1|Outcome|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
1119735|NCT00517829|E2|Reported Event|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
1119736|NCT00517829|E1|Reported Event|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
1119737|NCT00517751|B1|Baseline|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
1119738|NCT00517751|P1|Participant Flow|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
1119739|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
1119740|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
1119741|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
1119742|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
1119743|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
1119744|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
1119745|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
1119746|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
1119747|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
1119748|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
1119749|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
1119750|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
1119751|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
1119752|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
1119753|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
1119754|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
1119755|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
1119760|NCT00517595|B1|Baseline|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
1119761|NCT00517595|P1|Participant Flow|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
1119762|NCT00517595|O1|Outcome|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
1119763|NCT00517595|O1|Outcome|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
1119764|NCT00517595|O1|Outcome|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
1119765|NCT00517595|O1|Outcome|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
1119766|NCT00517595|O1|Outcome|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
1119767|NCT00517595|O1|Outcome|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
1119768|NCT00517595|E1|Reported Event|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
1119769|NCT00517556|B3|Baseline|Total|Total of all reporting groups
1119770|NCT00517556|B2|Baseline|Control Group (Traditional OCP)|treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for traditional (21 active days/7 inactive days) regimen through six cycles.
1119771|NCT00517556|B1|Baseline|Study Group (CCOCP)|treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles
1119772|NCT00517556|P2|Participant Flow|Control Group (Traditional OCP)|treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for traditional (21 active days/7 inactive days) regimen through six cycles.
1119773|NCT00517556|P1|Participant Flow|Study Group (CCOCP)|treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles
1119774|NCT00517556|O2|Outcome|Control Group (Traditional OCP)|treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for traditional (21 active days/7 inactive days) regimen through six cycles.
1119775|NCT00517556|O1|Outcome|Study Group (CCOCP)|treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles
1119776|NCT00517556|E2|Reported Event|Control Group (Traditional OCP)|treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for traditional (21 active days/7 inactive days) regimen through six cycles.
1119777|NCT00517556|E1|Reported Event|Study Group (CCOCP)|treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles
1119778|NCT00517530|B8|Baseline|Total|Total of all reporting groups
1119779|NCT00517530|B7|Baseline|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
1119780|NCT00517530|B6|Baseline|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
1119781|NCT00517530|B5|Baseline|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
1119782|NCT00517530|B4|Baseline|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
1119783|NCT00517530|B3|Baseline|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
1119784|NCT00517530|B2|Baseline|400-2000 mg Phase I, CLL|Obinutuzumab intravenous infusion
1119785|NCT00517530|B1|Baseline|50-2000 mg Phase I, NHL|Obinutuzumab intravenous infusion
1119786|NCT00517530|P7|Participant Flow|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
1119787|NCT00517530|P6|Participant Flow|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
1119788|NCT00517530|P5|Participant Flow|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
1119789|NCT00517530|P4|Participant Flow|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
1119790|NCT00517530|P3|Participant Flow|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
1119791|NCT00517530|P2|Participant Flow|400-2000 mg Phase I, CLL|Obinutuzumab intravenous infusion
1119792|NCT00517530|P1|Participant Flow|50-2000 mg Phase I, NHL|Obinutuzumab intravenous infusion
1119793|NCT00517530|O4|Outcome|2000 mg - Phase I, CLL|Obinutuzumab intravenous infusion
1119794|NCT00517530|O3|Outcome|1200 mg - Phase I, CLL|Obinutuzumab intravenous infusion
1119795|NCT00517530|O2|Outcome|800 mg - Phase I, CLL|Obinutuzumab intravenous infusion
1119796|NCT00517530|O1|Outcome|400 mg - Phase I, CLL|Obinutuzumab intravenous infusion
1119797|NCT00517530|O4|Outcome|2000 mg - Phase I, NHL|Obinutuzumab intravenous infusion
1119798|NCT00517530|O3|Outcome|1200 mg - Phase I, NHL|Obinutuzumab intravenous infusion
1119799|NCT00517530|O2|Outcome|800 mg - Phase I, NHL|Obinutuzumab intravenous infusion
1119800|NCT00517530|O1|Outcome|400 mg - Phase I, NHL|Obinutuzumab intravenous infusion
1119801|NCT00517530|O4|Outcome|2000 mg - Phase I, NHL|Obinutuzumab intravenous infusion
1119802|NCT00517530|O3|Outcome|1200 mg - Phase I, NHL|Obinutuzumab intravenous infusion
1119803|NCT00517530|O2|Outcome|800 mg - Phase I, NHL|Obinutuzumab intravenous infusion
1119804|NCT00517530|O1|Outcome|400 mg - Phase I, NHL|Obinutuzumab intravenous infusion
1119805|NCT00517530|O1|Outcome|Retreated Participants|Obinutuzumab intravenous infusion
1119806|NCT00517530|O5|Outcome|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
1119807|NCT00517530|O4|Outcome|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
1119808|NCT00517530|O3|Outcome|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
1119809|NCT00517530|O2|Outcome|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
1119810|NCT00517530|O1|Outcome|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
1119819|NCT00517530|O5|Outcome|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
1119820|NCT00517530|O4|Outcome|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
1119821|NCT00517530|O3|Outcome|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
1119822|NCT00517530|O2|Outcome|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
1119823|NCT00517530|O1|Outcome|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
1119824|NCT00517530|O5|Outcome|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
1119825|NCT00517530|O4|Outcome|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
1119826|NCT00517530|O3|Outcome|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
1119827|NCT00517530|O2|Outcome|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
1119828|NCT00517530|O1|Outcome|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
1119829|NCT00517530|O5|Outcome|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
1119830|NCT00517530|O4|Outcome|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
1119831|NCT00517530|O3|Outcome|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
1119832|NCT00517530|O2|Outcome|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
1119833|NCT00517530|O1|Outcome|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
1119834|NCT00517530|O5|Outcome|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
1119835|NCT00517530|O4|Outcome|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
1119836|NCT00517530|O3|Outcome|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
1119837|NCT00517530|O2|Outcome|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
1119838|NCT00517530|O1|Outcome|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
1119839|NCT00517530|O11|Outcome|1000/1000 mg - Phase I, CLL|Obinutuzumab intravenous infusion
1119840|NCT00517530|O10|Outcome|1200/2000 mg - Phase I, CLL|Obinutuzumab intravenous infusion
1119841|NCT00517530|O9|Outcome|800/1200 mg - Phase I, CLL|Obinutuzumab intravenous infusion
1119842|NCT00517530|O8|Outcome|400/800 mg - Phase I, CLL|Obinutuzumab intravenous infusion
1119843|NCT00517530|O7|Outcome|1600/800 mg - Phase I, NHL|Obinutuzumab intravenous infusion
1119844|NCT00517530|O6|Outcome|1200/2000 mg - Phase I, NHL|Obinutuzumab intravenous infusion
1119850|NCT00517530|E1|Reported Event|Safety Population|Safety-Evaluable Participants
1119851|NCT00517413|B1|Baseline|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
1119852|NCT00517413|P1|Participant Flow|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and previously treated with intravenous (IV) or subcutaneous (SC) epoetin alfa, epoetin beta or darbepoetin alfa received monthly treatment with Continuous Erythropoietin Receptor Activator (C.E.R.A.) (methoxy polyethylene glycol-epoetin beta [Mircera]). The initial dose of C.E.R.A. was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA); 120, 200, or 360 micrograms (mcg) C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
1119853|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
1119854|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
1119855|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
1119856|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
1119857|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
1119858|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
1119859|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
1119886|NCT00517296|O2|Outcome|Adalimumab|Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.
1120950|NCT00514813|P4|Participant Flow|Dynepo Once Every 4 Weeks (Q4W)|Epoetin delta dosed once every 4 weeks
1119860|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
1119861|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
1119862|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
1119863|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
1119864|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
1119865|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
1119866|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
1119867|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
1119868|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
1133074|NCT00479336|O1|Outcome|Placebo|Placebo, 1 tablet a day
1119869|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
1119870|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
1119871|NCT00517413|E1|Reported Event|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
1119872|NCT00517361|B1|Baseline|Carboplatin + Avastin|Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
1119873|NCT00517361|P1|Participant Flow|Carboplatin + Avastin|Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
1119874|NCT00517361|O1|Outcome|Carboplatin + Avastin|Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
1119875|NCT00517361|O1|Outcome|Carboplatin + Avastin|Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
1119876|NCT00517361|O1|Outcome|Carboplatin + Avastin|Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
1119877|NCT00517361|O1|Outcome|Carboplatin + Avastin|Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
1119878|NCT00517361|E1|Reported Event|Carboplatin + Avastin|Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
1119879|NCT00517296|B3|Baseline|Total|Total of all reporting groups
1119880|NCT00517296|B2|Baseline|Adalimumab|Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.
1119881|NCT00517296|B1|Baseline|Adalimumab With EUS Guided Therapy|Patients will be randomized to adalimumab treatment with EUS guided therapy decisions. Colorectal surgeon will have access to EUS data prior to EUA with possible seton placement.
1119882|NCT00517296|P2|Participant Flow|Adalimumab|Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.
1119883|NCT00517296|P1|Participant Flow|Adalimumab With EUS Guided Therapy|Patients will be randomized to adalimumab treatment with EUS guided therapy decisions. Colorectal surgeon will have access to EUS data prior to EUA with possible seton placement.
1119884|NCT00517296|O2|Outcome|Adalimumab|Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.
1119885|NCT00517296|O1|Outcome|Adalimumab With EUS Guided Therapy|Patients will be randomized to adalimumab treatment with EUS guided therapy decisions. Colorectal surgeon will have access to EUS data prior to EUA with possible seton placement.
1120000|NCT00516906|B3|Baseline|Total|Total of all reporting groups
1119887|NCT00517296|O1|Outcome|Adalimumab With EUS Guided Therapy|Patients will be randomized to adalimumab treatment with EUS guided therapy decisions. Colorectal surgeon will have access to EUS data prior to EUA with possible seton placement.
1119888|NCT00517296|O2|Outcome|Adalimumab|Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.
1119889|NCT00517296|O1|Outcome|Adalimumab With EUS Guided Therapy|Patients will be randomized to adalimumab treatment with EUS guided therapy decisions. Colorectal surgeon will have access to EUS data prior to EUA with possible seton placement.
1119890|NCT00517296|E2|Reported Event|B, Control Arm|Group B patients will be randomized to surgical guidance / standard of care
1119891|NCT00517296|E1|Reported Event|A, Combination Therapy Group|"Group A patients will be randomized to TNF and seton placement.~Seton placement: Patients randomized to the combination therapy group will have seton placement prior to initiating therapy with Certolizumab."
1119892|NCT00517192|B3|Baseline|Total|Total of all reporting groups
1119893|NCT00517192|B2|Baseline|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
1119894|NCT00517192|B1|Baseline|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
1119895|NCT00517192|P2|Participant Flow|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
1119896|NCT00517192|P1|Participant Flow|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
1119897|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
1119898|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
1119899|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
1119900|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
1119901|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
1119902|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
1119903|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
1119904|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
1119905|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
1119906|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
1119907|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
1119908|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
1119909|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
1119910|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
1119911|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
1119912|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
1119913|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
1119914|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
1119915|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
1119916|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
1119917|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
1119918|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
1119919|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
1120001|NCT00516906|B2|Baseline|CHG Antimicrobial Transparent Dressing|Chlorhexidine gluconate antimicrobial transparent adhesive dressing
1119920|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
1119921|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
1119922|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
1119923|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
1119924|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
1119925|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
1119926|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
1119927|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
1119928|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
1119929|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
1119930|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
1119931|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
1119932|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
1119933|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
1119934|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
1120036|NCT00516737|O1|Outcome|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
1119935|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
1119936|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
1119937|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
1119938|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
1119939|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
1119940|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
1119941|NCT00517192|E2|Reported Event|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
1119942|NCT00517192|E1|Reported Event|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
1119943|NCT00517075|B5|Baseline|Total|Total of all reporting groups
1119944|NCT00517075|B4|Baseline|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119945|NCT00517075|B3|Baseline|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1120002|NCT00516906|B1|Baseline|Placebo Comparator: A|Standard of Care Transparent Adhesive Dressing
1120003|NCT00516906|P2|Participant Flow|CHG Antimicrobial Transparent Dressing|Chlorhexidine gluconate antimicrobial transparent adhesive dressing
1120004|NCT00516906|P1|Participant Flow|Placebo Comparator: A|Standard of Care Transparent Adhesive Dressing
1120005|NCT00516906|O2|Outcome|CHG Antimicrobial Transparent Dressing|Chlorhexidine gluconate antimicrobial transparent adhesive dressing
1119946|NCT00517075|B2|Baseline|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119947|NCT00517075|B1|Baseline|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119948|NCT00517075|P4|Participant Flow|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119949|NCT00517075|P3|Participant Flow|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1120037|NCT00516737|O2|Outcome|Placebo|Matching placebo; one dose, treatment of a single migraine attack
1133075|NCT00479336|O4|Outcome|OPC-41061 30 mg|30 mg, 1 tablet a day
1119950|NCT00517075|P2|Participant Flow|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119951|NCT00517075|P1|Participant Flow|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119952|NCT00517075|O4|Outcome|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119953|NCT00517075|O3|Outcome|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119954|NCT00517075|O2|Outcome|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1120006|NCT00516906|O1|Outcome|Placebo Comparator: A|Standard of Care Transparent Adhesive Dressing
1120007|NCT00516906|O2|Outcome|CHG Antimicrobial Transparent Dressing|Chlorhexidine gluconate antimicrobial transparent adhesive dressing
1120008|NCT00516906|O1|Outcome|Placebo Comparator: A|Standard of Care Transparent Adhesive Dressing
1120009|NCT00516906|O2|Outcome|CHG Antimicrobial Transparent Dressing|Chlorhexidine gluconate antimicrobial transparent adhesive dressing
1119955|NCT00517075|O1|Outcome|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119956|NCT00517075|O4|Outcome|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119957|NCT00517075|O3|Outcome|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119958|NCT00517075|O2|Outcome|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119959|NCT00517075|O1|Outcome|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119960|NCT00517075|O4|Outcome|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119961|NCT00517075|O3|Outcome|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119962|NCT00517075|O2|Outcome|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119963|NCT00517075|O1|Outcome|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1120010|NCT00516906|O1|Outcome|Placebo Comparator: A|Standard of Care Transparent Adhesive Dressing
1120011|NCT00516906|E2|Reported Event|CHG Antimicrobial Transparent Dressing|Chlorhexidine gluconate antimicrobial transparent adhesive dressing
1120012|NCT00516906|E1|Reported Event|Placebo Comparator: A|Standard of Care Transparent Adhesive Dressing
1120955|NCT00514813|O3|Outcome|Dynepo Once Every 2 Weeks (Q2W)|Epoetin delta dosed once every 2 weeks
1119964|NCT00517075|O4|Outcome|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119965|NCT00517075|O3|Outcome|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119966|NCT00517075|O2|Outcome|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119967|NCT00517075|O1|Outcome|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119968|NCT00517075|O4|Outcome|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119969|NCT00517075|O3|Outcome|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119970|NCT00517075|O2|Outcome|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119971|NCT00517075|O1|Outcome|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119972|NCT00517075|O4|Outcome|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1120013|NCT00516893|B1|Baseline|Natalizumab High Titer|natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses
1120951|NCT00514813|P3|Participant Flow|Dynepo Once Every 2 Weeks (Q2W)|Epoetin delta dosed once every 2 weeks
1119973|NCT00517075|O3|Outcome|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119974|NCT00517075|O2|Outcome|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119975|NCT00517075|O1|Outcome|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119976|NCT00517075|O4|Outcome|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119977|NCT00517075|O3|Outcome|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119978|NCT00517075|O2|Outcome|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119979|NCT00517075|O1|Outcome|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119980|NCT00517075|O4|Outcome|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119981|NCT00517075|O3|Outcome|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1120014|NCT00516893|P1|Participant Flow|Natalizumab High Titer|natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses
1120015|NCT00516893|O1|Outcome|Natalizumab High Titer|natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses
1132981|NCT00479466|O4|Outcome|MK0893 60 mg|
1119982|NCT00517075|O2|Outcome|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119983|NCT00517075|O1|Outcome|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119984|NCT00517075|E4|Reported Event|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119985|NCT00517075|E3|Reported Event|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119986|NCT00517075|E2|Reported Event|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119987|NCT00517075|E1|Reported Event|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
1119988|NCT00517010|B1|Baseline|Lucentis Combined With Proton Beam|Proton beam irradiation and ranibizumab: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.
1119989|NCT00517010|P1|Participant Flow|Lucentis Combined With Proton Beam|Proton beam irradiation and ranibizumab: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.
1119990|NCT00517010|O1|Outcome|Lucentis Combined With Proton Beam|Proton beam irradiation and ranibizumab: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.
1119991|NCT00517010|O1|Outcome|Lucentis Combined With Proton Beam|Proton beam irradiation and ranibizumab: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.
1119992|NCT00517010|E1|Reported Event|Lucentis Combined With Proton Beam|Proton beam irradiation and ranibizumab: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.
1119993|NCT00516919|B1|Baseline|Total Enrollment|
1119994|NCT00516919|P2|Participant Flow|Placebo + Behavioral Intervention|"Drug: Placebo + Behavioral: behavioral intervention~Behavioral intervention + placebo : Behavioral weight loss treatment in Spanish Placebo three times a day"
1119995|NCT00516919|P1|Participant Flow|Xenical + Behavioral Intervention|"Drug: Xenical + Behavioral: behavioral intervention~Xenical + behavioral intervention : 120 mg three times a day; Behavioral weight loss in Spanish"
1119996|NCT00516919|O2|Outcome|Drug: Placebo + Behavioral: Behavioral Intervention|"Placebo + behavioral intervention~Behavioral intervention + placebo three times a day: Behavioral weight loss treatment in Spanish Placebo TID"
1119997|NCT00516919|O1|Outcome|Drug: Xenical + Behavioral: Behavioral Intervention|"Xenical + behavioral intervention~Xenical + behavioral intervention : 120 mg three times a day; Behavioral weight loss in Spanish"
1119998|NCT00516919|E2|Reported Event|Drug: Placebo + Behaviora: Behavioral Intervention|"Placebo + behavioral intervention~Behavioral intervention + placebo three times a day: Behavioral weight loss treatment in Spanish Placebo TID"
1119999|NCT00516919|E1|Reported Event|Drug: Xenical + Behavioral: Behavioral Intervention|"Xenical + behavioral intervention~Xenical + behavioral intervention : 120 mg three times a day; Behavioral weight loss in Spanish"
1120016|NCT00516893|O1|Outcome|Natalizumab High Titer|natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses
1120017|NCT00516893|O1|Outcome|Natalizumab High Titer|natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses
1120018|NCT00516893|O1|Outcome|Natalizumab High Titer|natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses
1120019|NCT00516893|E1|Reported Event|Natalizumab High Titer|natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses
1120020|NCT00516737|B3|Baseline|Total|Total of all reporting groups
1120021|NCT00516737|B2|Baseline|Placebo|Matching placebo; one dose, treatment of a single migraine attack
1120022|NCT00516737|B1|Baseline|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
1120023|NCT00516737|P2|Participant Flow|Placebo|Matching placebo; one dose, treatment of a single migraine attack
1120024|NCT00516737|P1|Participant Flow|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
1120025|NCT00516737|O2|Outcome|Placebo|Matching placebo; one dose, treatment of a single migraine attack
1120026|NCT00516737|O1|Outcome|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
1120027|NCT00516737|O2|Outcome|Placebo|Matching placebo; one dose, treatment of a single migraine attack
1120028|NCT00516737|O1|Outcome|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
1120029|NCT00516737|O2|Outcome|Placebo|Matching placebo; one dose, treatment of a single migraine attack
1120030|NCT00516737|O1|Outcome|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
1120031|NCT00516737|O2|Outcome|Placebo|Matching placebo; one dose, treatment of a single migraine attack
1120032|NCT00516737|O1|Outcome|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
1120033|NCT00516737|O2|Outcome|Placebo|Matching placebo; one dose, treatment of a single migraine attack
1120034|NCT00516737|O1|Outcome|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
1120035|NCT00516737|O2|Outcome|Placebo|Matching placebo; one dose, treatment of a single migraine attack
1120817|NCT00515008|O1|Outcome|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
1120038|NCT00516737|O1|Outcome|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
1120039|NCT00516737|E2|Reported Event|Placebo|Matching placebo; one dose, treatment of a single migraine attack
1120040|NCT00516737|E1|Reported Event|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
1120041|NCT00516386|B1|Baseline|RhIGF-1|All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.
1120042|NCT00516386|P1|Participant Flow|RhIGF-1|All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.
1120043|NCT00516386|O1|Outcome|RhIGF-1|All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.
1120044|NCT00516386|O1|Outcome|RhIGF-1|All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.
1120045|NCT00516386|E1|Reported Event|RhIGF-1|All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.
1120046|NCT00516321|B3|Baseline|Total|Total of all reporting groups
1120047|NCT00516321|B2|Baseline|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120048|NCT00516321|B1|Baseline|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120049|NCT00516321|P3|Participant Flow|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120050|NCT00516321|P2|Participant Flow|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120051|NCT00516321|P1|Participant Flow|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <90 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <90 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=90 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=90 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
1120052|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120053|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120054|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120055|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120056|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120057|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120058|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120059|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120060|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120117|NCT00516269|P2|Participant Flow|Placebo Then Methylphenidate|Placebo oral daily for 2 weeks then Methylphenidate 18 mg oral daily for 2 weeks
1120061|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120062|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120063|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120064|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120065|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120066|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120067|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120068|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120069|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120070|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120071|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120072|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120073|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120074|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120075|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120076|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120077|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120078|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120079|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120080|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120081|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120082|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120083|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120084|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120085|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120086|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120087|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120088|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120089|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120136|NCT00516165|O1|Outcome|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.~RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
1132982|NCT00479466|O3|Outcome|MK0893 40 mg|
1120090|NCT00516321|O1|Outcome|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <90 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <90 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=90 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=90 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
1120091|NCT00516321|O1|Outcome|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <90 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <90 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=90 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=90 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
1120092|NCT00516321|O1|Outcome|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <90 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <90 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=90 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=90 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
1120093|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120094|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120095|NCT00516321|E3|Reported Event|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120096|NCT00516321|E2|Reported Event|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
1120097|NCT00516321|E1|Reported Event|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <90 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <90 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=90 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=90 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
1120098|NCT00516295|B4|Baseline|Total|Total of all reporting groups
1120099|NCT00516295|B3|Baseline|Arm III (VTC)|Patients receive vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in arm I.
1120100|NCT00516295|B2|Baseline|Arm II (VTCB)|Patients receive bevacizumab, vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in Arm I
1120101|NCT00516295|B1|Baseline|Arm I (Feasibility Assessment of VTCB)|"Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 [course 5], 17, 18 [course 6], 26, 27 [course 9], 29, and 30 [course 10] when no chemotherapy is given) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~topotecan hydrochloride: Given IV~vincristine sulfate: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV"
1120102|NCT00516295|P3|Participant Flow|Arm III (CTC)|Patients receive vincristine, topotecan hydrochloride, and cyclophosphamide as in arm I.
1120103|NCT00516295|P2|Participant Flow|Arm II (VTCB)|Patients receive bevacizumab, vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in Arm I.
1120104|NCT00516295|P1|Participant Flow|Arm I (Feasibility Assessment of VTCB)|"Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 [course 5], 17, 18 [course 6], 26, 27 [course 9], 29, and 30 [course 10] when no chemotherapy is given) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~topotecan hydrochloride: Given IV~vincristine sulfate: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV"
1120105|NCT00516295|O3|Outcome|Arm III (VTC)|Patients receive vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in arm I.
1120106|NCT00516295|O2|Outcome|Arm II (VTCB)|Patients receive bevacizumab, vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in Arm I.
1120137|NCT00516165|E1|Reported Event|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.~RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
1120507|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120107|NCT00516295|O1|Outcome|Arm I (Feasibility Assessment of VTCB)|"Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 [course 5], 17, 18 [course 6], 26, 27 [course 9], 29, and 30 [course 10] when no chemotherapy is given) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~topotecan hydrochloride: Given IV~vincristine sulfate: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV"
1120108|NCT00516295|O3|Outcome|Arm III (VTC)|Patients receive vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in arm I.
1120109|NCT00516295|O2|Outcome|Arm II (VTCB)|Patients receive bevacizumab, vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in Arm I.
1120110|NCT00516295|O1|Outcome|Arm I (Feasibility Assessment of VTCB)|"Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 [course 5], 17, 18 [course 6], 26, 27 [course 9], 29, and 30 [course 10] when no chemotherapy is given) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~topotecan hydrochloride: Given IV~vincristine sulfate: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV"
1120111|NCT00516295|E3|Reported Event|Arm III (VTC)|Patients receive vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in arm I.
1120112|NCT00516295|E2|Reported Event|Arm II (VTCB)|Patients receive bevacizumab, vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in Arm I.
1120113|NCT00516295|E1|Reported Event|Arm I (Feasibility Assessment of VTCB)|"Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 [course 5], 17, 18 [course 6], 26, 27 [course 9], 29, and 30 [course 10] when no chemotherapy is given) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~topotecan hydrochloride: Given IV~vincristine sulfate: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV"
1120114|NCT00516269|B3|Baseline|Total|Total of all reporting groups
1120115|NCT00516269|B2|Baseline|Placebo Then Methylphenidate|"Placebo : Capsule By Mouth Daily x 2 Weeks~Methylphenidate : 18 mg By Mouth Daily x 2 Weeks"
1120116|NCT00516269|B1|Baseline|Methylphenidate Then Placebo|"18 mg Oral Daily for 2 Weeks~Placebo : Capsule By Mouth Daily x 2 Weeks~Methylphenidate : 18 mg By Mouth Daily x 2 Weeks"
1120818|NCT00515008|O2|Outcome|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
1120118|NCT00516269|P1|Participant Flow|Methylphenidate Then Placebo|Methylphenidate 18 mg oral daily for 2 weeks then Placebo oral daily for 2 weeks
1120119|NCT00516269|O2|Outcome|Placebo|Placebo taken oral daily for 2 Weeks.
1120120|NCT00516269|O1|Outcome|Methylphenidate|Methylphenidate 18 mg oral daily for 2 Weeks preceded or followed by Placebo oral daily for 2 weeks.
1120121|NCT00516269|E2|Reported Event|Placebo Then Methylphenidate|"Placebo : Capsule By Mouth Daily x 2 Weeks~Methylphenidate : 18 mg By Mouth Daily x 2 Weeks"
1120122|NCT00516269|E1|Reported Event|Methylphenidate Then Placebo|"18 mg Oral Daily for 2 Weeks~Placebo : Capsule By Mouth Daily x 2 Weeks~Methylphenidate : 18 mg By Mouth Daily x 2 Weeks"
1120123|NCT00516217|B1|Baseline|Galaximab|Induction: 500 mg/m^2 by IV over 60 minutes days 1, 8, 15 & 22 Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity
1120124|NCT00516217|P1|Participant Flow|Galaximab|Induction: 500 mg/m^2 by IV over 60 minutes days 1, 8, 15 & 22 Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity
1120125|NCT00516217|O1|Outcome|Galaximab|Induction: 500 mg/m^2 by IV over 60 minutes days 1, 8, 15 & 22 Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity
1120126|NCT00516217|O1|Outcome|Galaximab|Induction: 500 mg/m^2 by IV over 60 minutes days 1, 8, 15 & 22 Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity
1120127|NCT00516217|O1|Outcome|Galaximab|Induction: 500 mg/m^2 by IV over 60 minutes days 1, 8, 15 & 22 Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity
1120128|NCT00516217|E1|Reported Event|Galaximab|Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity
1120129|NCT00516165|B1|Baseline|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.~RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
1120130|NCT00516165|P1|Participant Flow|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.~RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
1120131|NCT00516165|O1|Outcome|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.~RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
1120132|NCT00516165|O1|Outcome|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.~RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
1120133|NCT00516165|O1|Outcome|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.~RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
1120134|NCT00516165|O1|Outcome|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.~RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
1120135|NCT00516165|O1|Outcome|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.~RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
1120138|NCT00516139|B1|Baseline|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
1120139|NCT00516139|P1|Participant Flow|Lamotrigine (LTG)-Extended Release (XR) Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
1120140|NCT00516139|O1|Outcome|LTG-XR + Neutral, EIAEDs, and VPA|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (included VPA and EIAEDs), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
1120819|NCT00515008|O1|Outcome|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
1120141|NCT00516139|O1|Outcome|LTG-XR + Neutral, EIAEDs, and VPA|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (included VPA and EIAEDs), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
1120142|NCT00516139|O3|Outcome|LTG-XR + VPA|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-w Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (included VPA), followed by an 8-w Adjunctive Maintenance Phase: LTG-XR tablets administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
1120143|NCT00516139|O2|Outcome|LTG-XR + EIAEDs|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-w Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (included EIAEDs), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
1120144|NCT00516139|O1|Outcome|LTG-XR + Neutral|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (does not include VPA or EIAEDs), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
1120202|NCT00516048|E2|Reported Event|Exenatide: Treatment-Emergent Antibody Positive|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodies to exenatide at any point in the study.
1120203|NCT00516048|E1|Reported Event|Exenatide:Treatment-Emergent Antibody Negative|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study.
1120204|NCT00515879|B3|Baseline|Total|Total of all reporting groups
1120145|NCT00516139|O3|Outcome|LTG-XR + VPA|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-w Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (included VPA), followed by an 8-w Adjunctive Maintenance Phase: LTG-XR tablets administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
1120146|NCT00516139|O2|Outcome|LTG-XR + EIAEDs|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-w Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (included EIAEDs), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
1120147|NCT00516139|O1|Outcome|LTG-XR + Neutral|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (does not include VPA or EIAEDs), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
1120820|NCT00515008|O2|Outcome|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
1120148|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
1120149|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
1120150|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
1120151|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
1120205|NCT00515879|B2|Baseline|Placebo-augmented CBT|Participants will receive placebo augmented cognitive behavioral therapy
1120206|NCT00515879|B1|Baseline|D-cycloserine-augmented CBT|Participants will receive D-cycloserine augmented cognitive behavioral therapy
1120207|NCT00515879|P2|Participant Flow|Placebo-augmented CBT|Participants will receive placebo augmented cognitive behavioral therapy
1120208|NCT00515879|P1|Participant Flow|D-cycloserine-augmented CBT|Participants will receive D-cycloserine augmented cognitive behavioral therapy
1120152|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
1120153|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
1120173|NCT00516074|O1|Outcome|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
1120174|NCT00516074|O2|Outcome|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
1120175|NCT00516074|O1|Outcome|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
1120176|NCT00516074|O2|Outcome|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
1120177|NCT00516074|O1|Outcome|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
1120821|NCT00515008|O1|Outcome|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
1120154|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
1120155|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
1120156|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
1120157|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
1120158|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
1120209|NCT00515879|O2|Outcome|Placebo-augmented CBT|Participants will receive placebo augmented cognitive behavioral therapy
1120210|NCT00515879|O1|Outcome|D-cycloserine-augmented CBT|Participants will receive D-cycloserine augmented cognitive behavioral therapy
1120211|NCT00515879|O2|Outcome|Placebo-augmented CBT|Participants will receive placebo augmented cognitive behavioral therapy
1120952|NCT00514813|P2|Participant Flow|Dynepo Once Weekly (QW)|Epoetin delta dosed once-a-week
1120159|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
1120160|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
1120161|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
1120162|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
1120163|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
1120164|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
1120165|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
1120212|NCT00515879|O1|Outcome|D-cycloserine-augmented CBT|Participants will receive D-cycloserine augmented cognitive behavioral therapy
1120213|NCT00515879|E2|Reported Event|Placebo-augmented CBT|Participants will receive placebo augmented cognitive behavioral therapy
1120214|NCT00515879|E1|Reported Event|D-cycloserine-augmented CBT|Participants will receive D-cycloserine augmented cognitive behavioral therapy
1120215|NCT00515827|B3|Baseline|Total|Total of all reporting groups
1120166|NCT00516139|E1|Reported Event|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
1120167|NCT00516074|B3|Baseline|Total|Total of all reporting groups
1120168|NCT00516074|B2|Baseline|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
1120169|NCT00516074|B1|Baseline|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
1120170|NCT00516074|P2|Participant Flow|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
1120171|NCT00516074|P1|Participant Flow|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
1120172|NCT00516074|O2|Outcome|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
1133076|NCT00479336|O3|Outcome|OPC-41061 15 mg|15 mg, 1 tablet a day
1120178|NCT00516074|O2|Outcome|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
1120179|NCT00516074|O1|Outcome|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
1120180|NCT00516074|O2|Outcome|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
1120181|NCT00516074|O1|Outcome|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
1120182|NCT00516074|O2|Outcome|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
1120183|NCT00516074|O1|Outcome|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
1120184|NCT00516074|E2|Reported Event|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
1120185|NCT00516074|E1|Reported Event|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
1120186|NCT00516048|B3|Baseline|Total|Total of all reporting groups
1120187|NCT00516048|B2|Baseline|Positive Baseline (Week 0) Antibody Status|Patients assessed as positive for antibodies to exenatide at baseline (Week 0).
1120188|NCT00516048|B1|Baseline|Negative Baseline (Week 0) Antibody Status|Patients assessed as negative for antibodies to exenatide at baseline (Week 0).
1120189|NCT00516048|P3|Participant Flow|Enrolled But Withdrew Before Receiving Treatment|No exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted.
1120190|NCT00516048|P2|Participant Flow|Exenatide: Treatment-Emergent Antibody Positive|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodies to exenatide at any point in the study.
1120191|NCT00516048|P1|Participant Flow|Exenatide:Treatment-Emergent Antibody Negative|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study.
1120192|NCT00516048|O3|Outcome|Enrolled But Withdrew Before Receiving Treatment|No exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted.
1120193|NCT00516048|O2|Outcome|Exenatide: Treatment-Emergent Antibody Positive|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodies to exenatide at any point in the study.
1120194|NCT00516048|O1|Outcome|Exenatide:Treatment-Emergent Antibody Negative|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study.
1120195|NCT00516048|O3|Outcome|Enrolled But Withdrew Before Receiving Treatment|No exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted.
1120196|NCT00516048|O2|Outcome|Exenatide: Treatment-Emergent Antibody Positive|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodies to exenatide at any point in the study.
1120197|NCT00516048|O1|Outcome|Exenatide:Treatment-Emergent Antibody Negative|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study.
1120198|NCT00516048|O3|Outcome|Enrolled But Withdrew Before Receiving Treatment|No exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted.
1120199|NCT00516048|O2|Outcome|Exenatide: Treatment-Emergent Antibody Positive|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodies to exenatide at any point in the study.
1120200|NCT00516048|O1|Outcome|Exenatide:Treatment-Emergent Antibody Negative|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study.
1120201|NCT00516048|E3|Reported Event|Enrolled But Withdrew Before Receiving Treatment|No exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted.
1120216|NCT00515827|B2|Baseline|Placebo Then Raltegravir (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12; halt placebo at Week 12 and add 400 mg raltegravir tablet twice daily for 12 weeks.
1120217|NCT00515827|B1|Baseline|Raltegravir Then Placebo (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12; halt raltegravir at Week 12 and add placebo twice daily for 12 weeks
1120218|NCT00515827|P2|Participant Flow|Placebo Then Raltegravir (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12; halt placebo at Week 12 and add 400 mg raltegravir tablet twice daily for 12 weeks.
1120219|NCT00515827|P1|Participant Flow|Raltegravir Then Placebo (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12; halt raltegravir at Week 12 and add placebo twice daily for 12 weeks
1120220|NCT00515827|O2|Outcome|Placebo (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12
1120221|NCT00515827|O1|Outcome|Raltegravir (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
1120222|NCT00515827|O2|Outcome|Raltegravir (Arm B)|400 mg raltegravir (MK-0518) administered twice daily in addition to OBR from week 12 to week 24
1120223|NCT00515827|O1|Outcome|Placebo (Arm A)|Placebo administered twice daily in addition to optimized background regimen (OBR) from week 12 to week 24
1120224|NCT00515827|O2|Outcome|Placebo (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12
1120225|NCT00515827|O1|Outcome|Raltegravir (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
1120226|NCT00515827|O2|Outcome|Placebo (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12
1120227|NCT00515827|O1|Outcome|Raltegravir (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
1120228|NCT00515827|O2|Outcome|Placebo (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12
1120229|NCT00515827|O1|Outcome|Raltegravir (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
1120230|NCT00515827|O2|Outcome|Placebo (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12
1120231|NCT00515827|O1|Outcome|Raltegravir (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
1120232|NCT00515827|O2|Outcome|Placebo (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12
1120233|NCT00515827|O1|Outcome|Raltegravir (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
1120234|NCT00515827|O2|Outcome|Placebo (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12
1120235|NCT00515827|O1|Outcome|Raltegravir (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
1120236|NCT00515827|O2|Outcome|Placebo (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12
1120237|NCT00515827|O1|Outcome|Raltegravir (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
1120238|NCT00515827|E2|Reported Event|Placebo|Week 12 to Week 24 for Arm A (Raltegravir then Placebo), and Baseline to Week 12 for Arm B (Placebo then Raltegravir).
1120239|NCT00515827|E1|Reported Event|Raltegravir|Baseline to Week 12 for Arm A (Raltegravir then Placebo), and Week 12 to Week 24 for Arm B (Placebo then Raltegravir).
1120240|NCT00515697|B1|Baseline|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
1120241|NCT00515697|P1|Participant Flow|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
1120242|NCT00515697|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
1120243|NCT00515697|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
1120244|NCT00515697|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
1120245|NCT00515697|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
1120246|NCT00515697|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
1120247|NCT00515697|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
1120248|NCT00515697|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
1120249|NCT00515697|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
1120250|NCT00515697|E1|Reported Event|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
1120251|NCT00515671|B3|Baseline|Total|Total of all reporting groups
1120506|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120252|NCT00515671|B2|Baseline|Arm 2|"Receives support groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
1120253|NCT00515671|B1|Baseline|Arm 1|"Receives IMR groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
1120254|NCT00515671|P2|Participant Flow|Arm 2|"Receives support groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
1120255|NCT00515671|P1|Participant Flow|Arm 1|"Receives IMR groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
1120256|NCT00515671|O2|Outcome|Arm 2|"Receives support groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
1120257|NCT00515671|O1|Outcome|Arm 1|"Receives IMR groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
1120258|NCT00515671|O2|Outcome|Arm 2|"Receives support groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
1120259|NCT00515671|O1|Outcome|Arm 1|"Receives IMR groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
1120260|NCT00515671|E2|Reported Event|Arm 2|"Receives support groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
1120685|NCT00515203|O2|Outcome|Placebo|Placebo by subcutaneous injection once weekly
1120261|NCT00515671|E1|Reported Event|Arm 1|"Receives IMR groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
1120262|NCT00515619|B1|Baseline|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
1120263|NCT00515619|P1|Participant Flow|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
1120264|NCT00515619|O1|Outcome|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
1120265|NCT00515619|O1|Outcome|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
1120266|NCT00515619|O1|Outcome|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
1120267|NCT00515619|O1|Outcome|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
1120268|NCT00515619|O1|Outcome|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
1120269|NCT00515619|E1|Reported Event|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
1120270|NCT00515541|B5|Baseline|Total|Total of all reporting groups
1120271|NCT00515541|B4|Baseline|Group D: Subject on Lovaza + Warfarin + Aspirin|Group D: Subject is taking Warfarin and Aspirin (< or = 325mg)and is not taking Clopidogrel. Subject is taking escalating doses of Lovaza over a 24 week period.
1120272|NCT00515541|B3|Baseline|Group C: Subject on Lovaza + Clopidogrel + Aspirin|Group C: Subject is taking Clopidogrel 75mg)and Aspirin (< or = 325mg) and not taking Warfarin. Subject is taking escalating doses of Lovaza over a 24 week period.
1120273|NCT00515541|B2|Baseline|Group. B: Subject on Lovaza + Aspirin|Group B: Subject on Aspirin (< or = 325mg and is not taking Clopidogrel or Warfarin. Subject is taking escalating doses of Lovaza over a 24 week period.
1120274|NCT00515541|B1|Baseline|Group A: Subject on Lovaza Only|Group A: Subject is not on Aspirin, Clopidogrel, or Warfarin. Subject is taking escalating doses of study drug (Lovaza)over a 24 week period.
1120275|NCT00515541|P4|Participant Flow|Group D: Subjects on Lovaza Plus Warfarin and Aspirin|Subject is regularly taking Warfarin and Aspirin (< or = 325mg)daily, and not taking Clopidogrel. Subjects will be taking escalating doses of study drug (Lovaza)in addition to Warfarin and Aspirin up to 24 weeks.
1120276|NCT00515541|P3|Participant Flow|Group C: Subjects on Lovaza Plus Clopidogrel and Aspirin|Subject is regularly taking Clopidogrel (75mg)and Aspirin (< or = 325mg)daily, and not taking Warfarin. Subjects will be taking escalating doses of study drug (Lovaza)in addition to Clopidogrel and Aspirin up to 24 weeks.
1120277|NCT00515541|P2|Participant Flow|Group B: Subjects on Lovaza Plus Aspirin|Group B: Subject is only taking Aspirin (< or = 325mg) daily. Subjects will be taking escalating doses of study drug (Lovaza) in addition to aspirin up to 24 weeks.
1120278|NCT00515541|P1|Participant Flow|Group A: Subjects on Lovaza Only|Group A: Subject is healthly and not on Aspirin, Clopidogrel, or Warfarin. Subjects will be taking escalating doses of the study drug (Lovaza)up to 24 weeks.
1120279|NCT00515541|O4|Outcome|Group D: Subject on Lovaza + Warfarin + Aspirin|Group D: Subject on study drug (Lovaza) plus Warfarin and Aspirin (< or = 325mg, and not on Clopidogrel. Subject on escalating doses of Lovaza over a 24 week period.
1120280|NCT00515541|O3|Outcome|Group C: Subject on Lovaza + Clopidogrel + Aspirin|Group C: Subject on study drug (Lovaza) plus Clopidogrel (75mg) and Aspirin (< or = 325mg, and not on Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
1120281|NCT00515541|O2|Outcome|Group B: Subject on Lovaza + Aspirin|Group B: Subject on study drug (Lovaza) plus Aspirin (< or = 35mg)and not on Clopidogrel or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
1120508|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120282|NCT00515541|O1|Outcome|Group A: Subject on Lovaza Only|Group A: Subject on study drug (Lovaza) and not on Aspirin, Clopidogrel, or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
1120283|NCT00515541|O4|Outcome|Group D: Subject on Lovaza + Warfarin + Aspirin|Group D: Subject on study drug (Lovaza) plus Warfarin and Aspirin (< or = 325mg, and not on Clopidogrel. Subject on escalating doses of Lovaza over a 24 week period.
1120284|NCT00515541|O3|Outcome|Group C: Subject on Lovaza + Clopidogrel + Aspirin|Group C: Subject on study drug (Lovaza) plus Clopidogrel (75mg) and Aspirin (< or = 325mg, and not on Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
1120285|NCT00515541|O2|Outcome|Group B: Subject on Lovaza + Aspirin|Group B: Subject on study drug (Lovaza) plus Aspirin (< or = 35mg)and not on Clopidogrel or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
1120286|NCT00515541|O1|Outcome|Group A: Subject on Lovaza Only|Group A: Subject on study drug (Lovaza) and not on Aspirin, Clopidogrel, or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
1120287|NCT00515541|O4|Outcome|Group D: Subject on Lovaza + Warfarin + Aspirin|Group D: Subject on study drug (Lovaza) plus Warfarin and Aspirin (< or = 325mg, and not on Clopidogrel. Subject on escalating doses of Lovaza over a 24 week period.
1120288|NCT00515541|O3|Outcome|Group C: Subject on Lovaza + Clopidogrel + Aspirin|Group C: Subject on study drug (Lovaza) plus Clopidogrel (75mg) and Aspirin (< or = 325mg, and not on Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
1120289|NCT00515541|O2|Outcome|Group B: Subject on Lovaza + Aspirin|Group B: Subject on study drug (Lovaza) plus Aspirin (< or = 35mg)and not on Clopidogrel or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
1120290|NCT00515541|O1|Outcome|Group A: Subject on Lovaza Only|Group A: Subject on study drug (Lovaza) and not on Aspirin, Clopidogrel, or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
1120291|NCT00515541|O4|Outcome|Group D: Subject on Lovaza + Warfarin + Aspirin|Group D: Subject on study drug (Lovaza) plus Warfarin and Aspirin (< or = 325mg, and not on Clopidogrel. Subject on escalating doses of Lovaza over a 24 week period.
1120292|NCT00515541|O3|Outcome|Group C: Subject on Lovaza + Clopidogrel + Aspirin|Group C: Subject on study drug (Lovaza) plus Clopidogrel (75mg) and Aspirin (< or = 325mg, and not on Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
1120293|NCT00515541|O2|Outcome|Group B: Subject on Lovaza + Aspirin|Group B: Subject on study drug (Lovaza) plus Aspirin (< or = 35mg)and not on Clopidogrel or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
1120294|NCT00515541|O1|Outcome|Group A: Subject on Lovaza Only|Group A: Subject on study drug (Lovaza) and not on Aspirin, Clopidogrel, or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
1120295|NCT00515541|E4|Reported Event|Group D|Lovaza plus aspirin plus coumadin
1120296|NCT00515541|E3|Reported Event|Group C|Lovaza plus clopidogrel
1120297|NCT00515541|E2|Reported Event|Group B|Lovaza plus aspirin
1120298|NCT00515541|E1|Reported Event|Group A|Lovaza only
1120299|NCT00515502|B1|Baseline|All Study Treatments|Participants received a sequence containing 4 of the following 5 possible treatments: placebo, UMEC 250 µg, UMEC 500 µg, UMEC 1000 µg and Tiotropium 18 µg. Participants received each of the treatments in 1 of 4 single dose treatment periods, each of which was followed by a washout period. Treatment periods 1, 2, and 3 were followed by at least a 14-day washout period; Treatment period 4 was followed by a Follow-up visit within 10 days.
1120300|NCT00515502|P12|Participant Flow|Seq 12: UMEC 250 µg, Placebo, UMEC 500 µg, Tiotropium 18 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, placebo, UMEC 500 µg and Tiotropium 18 µg. Treatment periods were seperated by a washout period of at least 14 days.
1120301|NCT00515502|P11|Participant Flow|Seq 11: Placebo, UMEC 250 µg, Tiotropium 18 µg, UMEC 500 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Placebo, UMEC 250 µg, Tiotropium 18 µg and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days.
1120302|NCT00515502|P10|Participant Flow|Seq 10: Tiotropium 18 µg, UMEC 250 µg, Placebo, UMEC 500 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Tiotropium 18 µg, UMEC 250 µg, placebo and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days.
1120303|NCT00515502|P9|Participant Flow|Seq 9: Tiotropium 18 µg, UMEC 250 µg, UMEC 500 µg, Placebo|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Tiotropium 18 µg, UMEC 250 µg, UMEC 500 µg and placebo. Treatment periods were seperated by a washout period of at least 14 days.
1120304|NCT00515502|P8|Participant Flow|Seq 8: Tiotropium 18 µg, Placebo, UMEC 250 µg, UMEC 500 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Tiotropium 18 µg, placebo, UMEC 250 µg and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days.
1120305|NCT00515502|P7|Participant Flow|Seq 7: Placebo, Tiotropium 18 µg, UMEC 250 µg, UMEC 500 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Placebo, Tiotropium 18 µg, UMEC 250 µg and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days.
1120306|NCT00515502|P6|Participant Flow|Seq 6: UMEC 250 µg, Placebo, Tiotropium 18 µg, UMEC 500 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, placebo, Tiotropium 18 µg and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days.
1120307|NCT00515502|P5|Participant Flow|Seq 5: Placebo, UMEC 250 µg, UMEC 500 µg, UMEC 1000 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Placebo, UMEC 250 µg, UMEC 500 µg and UMEC 1000 µg. Treatment periods were seperated by a washout period of at least 14 days.
1120308|NCT00515502|P4|Participant Flow|Seq 4: UMEC 250 µg, UMEC 500 µg, Placebo, UMEC 1000 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, UMEC 500 µg, placebo and UMEC 1000 µg. Treatment periods were seperated by a washout period of at least 14 days.
1120309|NCT00515502|P3|Participant Flow|Seq 3: UMEC 250 µg, Placebo, UMEC 500 µg, UMEC 1000 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, placebo, UMEC 500 µg and UMEC 1000 µg. Treatment periods were seperated by a washout period of at least 14 days.
1132983|NCT00479466|O2|Outcome|MK0893 20 mg|
1120310|NCT00515502|P2|Participant Flow|Seq 2: UMEC 250 µg, UMEC 500 µg, UMEC 1000 µg, Placebo|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, UMEC 500 µg, UMEC 1000 µg and placebo. Treatment periods were seperated by a washout period of at least 14 days.
1120311|NCT00515502|P1|Participant Flow|Seq 1: UMEC 250 µg, UMEC 500 µg, Tiotropium 18 µg, Placebo|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: umeclidinium bromide (UMEC) 250 micrograms (µg), UMEC 500 µg, Tiotropium 18 µg and placebo. Treatment periods were seperated by a washout period of at least 14 days.
1120312|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120313|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120314|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120315|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120316|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120317|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120318|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120319|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1133077|NCT00479336|O2|Outcome|OPC-41061 7.5 mg|7.5 mg, 1 tablet a day
1120320|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120321|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120322|NCT00515502|O3|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120323|NCT00515502|O2|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120324|NCT00515502|O1|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120325|NCT00515502|O3|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120326|NCT00515502|O2|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120327|NCT00515502|O1|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120328|NCT00515502|O3|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120329|NCT00515502|O2|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120330|NCT00515502|O1|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120331|NCT00515502|O3|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120332|NCT00515502|O2|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120333|NCT00515502|O1|Outcome|UMEC 250 µg|
1120334|NCT00515502|O3|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120335|NCT00515502|O2|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120336|NCT00515502|O1|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120337|NCT00515502|O3|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120338|NCT00515502|O2|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120339|NCT00515502|O1|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120340|NCT00515502|O3|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120341|NCT00515502|O2|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120342|NCT00515502|O1|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120343|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120344|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120345|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120346|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120347|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120348|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120349|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120350|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120351|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120352|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120353|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120354|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120355|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120356|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120357|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120358|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120359|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120360|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120361|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120362|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120363|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120364|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120365|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120366|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120367|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120368|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120369|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120370|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120371|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1132984|NCT00479466|O1|Outcome|Placebo|
1120372|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120373|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120374|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120375|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120376|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120377|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120378|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120379|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120380|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120381|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120382|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120383|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120384|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120385|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120386|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120387|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120388|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120389|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120390|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120391|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120392|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120393|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120394|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120395|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120396|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120397|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120398|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120399|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120400|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120401|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120402|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1132985|NCT00479466|E6|Reported Event|Metformin HCL|
1120403|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120404|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120405|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120406|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120407|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120408|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120409|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120410|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120411|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120412|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120413|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120414|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120415|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120416|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120417|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120418|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120419|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120420|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120421|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120422|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120423|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120424|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120425|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120426|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120427|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120428|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120429|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120430|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120431|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120432|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120433|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1132986|NCT00479466|E5|Reported Event|MK0893 80 mg|
1120434|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120435|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120436|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120437|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120438|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120439|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120440|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120441|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120442|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120443|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120444|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120445|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120446|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120447|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120448|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120449|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120450|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120451|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120452|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120453|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120454|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120455|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120456|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120457|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120458|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120459|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120460|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120461|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 micrograms (µg) via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120462|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120463|NCT00515502|E5|Reported Event|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120464|NCT00515502|E4|Reported Event|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120465|NCT00515502|E3|Reported Event|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120466|NCT00515502|E2|Reported Event|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120467|NCT00515502|E1|Reported Event|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
1120468|NCT00515463|B3|Baseline|Total|Total of all reporting groups
1120469|NCT00515463|B2|Baseline|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120470|NCT00515463|B1|Baseline|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120471|NCT00515463|P2|Participant Flow|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120472|NCT00515463|P1|Participant Flow|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120473|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120474|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120475|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120476|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120477|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120478|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1133078|NCT00479336|O1|Outcome|Placebo|Placebo, 1 tablet a day
1120479|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120480|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120481|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120482|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120483|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120484|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120485|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120486|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120487|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120488|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120489|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120490|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120491|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120492|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120493|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120494|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120495|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120496|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120497|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120498|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120499|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120500|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120501|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120502|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120503|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120504|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120505|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120956|NCT00514813|O2|Outcome|Dynepo Once Weekly (QW)|Epoetin delta dosed once-a-week
1120509|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120510|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120511|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120512|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120513|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120514|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120515|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120516|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120517|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120518|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120519|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120520|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120521|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120522|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120812|NCT00515008|O2|Outcome|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
1120523|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120524|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120525|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120526|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120527|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120528|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120529|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120530|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120531|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120532|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120533|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120534|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120535|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120536|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120537|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120538|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120539|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120540|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120541|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120542|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120543|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120544|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120545|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120546|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120547|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120548|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120549|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120550|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1132987|NCT00479466|E4|Reported Event|MK0893 60 mg|
1120551|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120552|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120553|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120554|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120555|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120556|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120557|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120558|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120559|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120560|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120561|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120562|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120563|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120564|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120565|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120566|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120567|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120568|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120569|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120570|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120571|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120572|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120573|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120574|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120575|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120576|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120577|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120578|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120579|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120580|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120581|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120582|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120583|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120584|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120585|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120586|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120587|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120588|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120589|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120590|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120591|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120592|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1132988|NCT00479466|E3|Reported Event|MK0893 40 mg|
1120593|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120594|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120595|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120596|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120597|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120598|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120599|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120600|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120601|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120602|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120603|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120604|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120605|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120606|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120607|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120608|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120609|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120610|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120611|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120612|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120613|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120614|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120615|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120616|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120617|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe (PFS) on Day 1 and at Month 6.
1120618|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120619|NCT00515463|E2|Reported Event|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
1120620|NCT00515463|E1|Reported Event|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
1120621|NCT00515437|B5|Baseline|Total|Total of all reporting groups
1120622|NCT00515437|B4|Baseline|Placebo|Placebo
1120623|NCT00515437|B3|Baseline|3500U Myobloc|3500U Myobloc
1120624|NCT00515437|B2|Baseline|2500U Myobloc|2500U Myobloc
1120625|NCT00515437|B1|Baseline|1500U Myobloc|1500U Myobloc
1120626|NCT00515437|P4|Participant Flow|Placebo|Placebo
1120627|NCT00515437|P3|Participant Flow|3500U Myobloc|3500U Myobloc
1120628|NCT00515437|P2|Participant Flow|2500U Myobloc|2500U Myobloc
1120629|NCT00515437|P1|Participant Flow|1500U Myobloc|1500U Myobloc
1120630|NCT00515437|O4|Outcome|Placebo|Placebo
1120631|NCT00515437|O3|Outcome|3500U Myobloc|3500U Myobloc
1120632|NCT00515437|O2|Outcome|2500U Myobloc|2500U Myobloc
1120633|NCT00515437|O1|Outcome|1500U Myobloc|1500U Myobloc
1120634|NCT00515437|O4|Outcome|Placebo|Placebo
1120635|NCT00515437|O3|Outcome|3500U Myobloc|3500U Myobloc
1120636|NCT00515437|O2|Outcome|2500U Myobloc|2500U Myobloc
1120637|NCT00515437|O1|Outcome|1500U Myobloc|1500U Myobloc
1120638|NCT00515437|O4|Outcome|Placebo|Placebo
1120639|NCT00515437|O3|Outcome|3500U Myobloc|3500U Myobloc
1120640|NCT00515437|O2|Outcome|2500U Myobloc|2500U Myobloc
1120641|NCT00515437|O1|Outcome|1500U Myobloc|1500U Myobloc
1120642|NCT00515437|O4|Outcome|Placebo|Placebo
1120643|NCT00515437|O3|Outcome|3500U Myobloc|3500U Myobloc
1120644|NCT00515437|O2|Outcome|2500U Myobloc|2500U Myobloc
1120645|NCT00515437|O1|Outcome|1500U Myobloc|1500U Myobloc
1120646|NCT00515437|E4|Reported Event|Placebo|Placebo
1120647|NCT00515437|E3|Reported Event|3500U Myobloc|3500U Myobloc
1120648|NCT00515437|E2|Reported Event|2500U Myobloc|2500U Myobloc
1120649|NCT00515437|E1|Reported Event|1500U Myobloc|1500U Myobloc
1120851|NCT00514943|O2|Outcome|Cetuximab mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1
1120650|NCT00515216|B1|Baseline|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
1120651|NCT00515216|P1|Participant Flow|Oxaliplatin/Leucovorin/5-FU|"“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype~Chemotherapy: 5-FU, leucovorin and oxaliplatin (FOLFOX)"
1120652|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
1120653|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
1120654|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
1120655|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
1120656|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
1120813|NCT00515008|O1|Outcome|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
1120657|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
1120658|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
1120659|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
1120660|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
1120661|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
1120662|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
1120663|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
1120664|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
1120665|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
1120666|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|"“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype~Chemotherapy: 5-FU, leucovorin and oxaliplatin (FOLFOX)"
1120667|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
1120668|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
1120669|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
1120670|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
1120852|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg in stage 1
1120671|NCT00515216|E1|Reported Event|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
1120672|NCT00515203|B3|Baseline|Total|Total of all reporting groups
1120673|NCT00515203|B2|Baseline|Placebo|Placebo by subcutaneous injection once weekly
1120674|NCT00515203|B1|Baseline|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
1120675|NCT00515203|P2|Participant Flow|Placebo|Placebo by subcutaneous injection once weekly
1120676|NCT00515203|P1|Participant Flow|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
1120677|NCT00515203|O2|Outcome|Placebo|Placebo by subcutaneous injection once weekly
1120678|NCT00515203|O1|Outcome|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
1120679|NCT00515203|O2|Outcome|Placebo|Placebo by subcutaneous injection once weekly
1120680|NCT00515203|O1|Outcome|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
1120681|NCT00515203|O2|Outcome|Placebo|Placebo by subcutaneous injection once weekly
1120682|NCT00515203|O1|Outcome|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
1120683|NCT00515203|O2|Outcome|Placebo|Placebo by subcutaneous injection once weekly
1120684|NCT00515203|O1|Outcome|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
1120686|NCT00515203|O1|Outcome|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
1120687|NCT00515203|O2|Outcome|Placebo|Placebo by subcutaneous injection once weekly
1120688|NCT00515203|O1|Outcome|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
1120689|NCT00515203|E2|Reported Event|Romiplostim|
1120690|NCT00515203|E1|Reported Event|Placebo|
1120691|NCT00515177|B3|Baseline|Total|Total of all reporting groups
1120692|NCT00515177|B2|Baseline|Randomized to PCT|
1120693|NCT00515177|B1|Baseline|Randomized to MBSR|
1120694|NCT00515177|P2|Participant Flow|Pharmacotherapy Control Arm|"A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.~eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of as needed use"
1120695|NCT00515177|P1|Participant Flow|MBSR|"A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.~Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness."
1120696|NCT00515177|O2|Outcome|Pharmacotherapy Control Arm|"A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.~eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of as needed use"
1120697|NCT00515177|O1|Outcome|MBSR|"A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.~Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness."
1120698|NCT00515177|O2|Outcome|Pharmacotherapy Control Arm|"A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.~eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of as needed use"
1120699|NCT00515177|O1|Outcome|MBSR|"A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.~Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness."
1120700|NCT00515177|O2|Outcome|Pharmacotherapy Control Arm|"A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.~eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of as needed use"
1120701|NCT00515177|O1|Outcome|MBSR|"A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.~Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness."
1120702|NCT00515177|O2|Outcome|Pharmacotherapy Control Arm|"A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.~eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of as needed use"
1120703|NCT00515177|O1|Outcome|MBSR|"A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.~Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness."
1120704|NCT00515177|O2|Outcome|Pharmacotherapy Control Arm|"A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.~eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of as needed use."
1120705|NCT00515177|O1|Outcome|MBSR|"A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.~Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness."
1120706|NCT00515177|O2|Outcome|Pharmacotherapy Control Arm|"A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.~eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of as needed use"
1120707|NCT00515177|O1|Outcome|MBSR|"A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.~Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness."
1120814|NCT00515008|O2|Outcome|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
1120708|NCT00515177|E2|Reported Event|MBSR|Mindfulness-Based Stress Reduction (MBSR) is an 8 week program of yoga and mindfulness training taught by a trained instructor in a group format.
1120709|NCT00515177|E1|Reported Event|Pharmacotherapy (Eszopiclone, 3mg)|The PCT control treatment consisted of 3mg eszopiclone nightly for 8 weeks, followed by use as needed for 3 months.
1120710|NCT00515112|B3|Baseline|Total|Total of all reporting groups
1120711|NCT00515112|B2|Baseline|Placebo|"Three subjects received the placebo~Placebo: placebo"
1120712|NCT00515112|B1|Baseline|Androgel|"Three subjects received testosterone gel~AndroGel: Androgel 1%, 10g daily"
1120713|NCT00515112|P2|Participant Flow|Placebo|"Three subjects received the placebo~Placebo: placebo"
1120714|NCT00515112|P1|Participant Flow|Androgel|"Three subjects received testosterone gel~AndroGel: Androgel 1%, 10g daily"
1120715|NCT00515112|O2|Outcome|Placebo|"Three subjects received the placebo~Placebo: placebo"
1120716|NCT00515112|O1|Outcome|Androgel|"Three subjects received testosterone gel~AndroGel: Androgel 1%, 10g daily"
1120717|NCT00515112|O2|Outcome|Placebo|"Three subjects received the placebo~Placebo: placebo"
1120718|NCT00515112|O1|Outcome|Androgel|"Three subjects received testosterone gel~AndroGel: Androgel 1%, 10g daily"
1120719|NCT00515112|E2|Reported Event|Placebo|"Three subjects received the placebo~Placebo: placebo"
1120720|NCT00515112|E1|Reported Event|Androgel|"Three subjects received testosterone gel~AndroGel: Androgel 1%, 10g daily"
1120721|NCT00515099|B3|Baseline|Total|Total of all reporting groups
1120722|NCT00515099|B2|Baseline|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
1120723|NCT00515099|B1|Baseline|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
1120724|NCT00515099|P2|Participant Flow|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
1120725|NCT00515099|P1|Participant Flow|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
1120726|NCT00515099|O2|Outcome|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
1120727|NCT00515099|O1|Outcome|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
1120728|NCT00515099|O2|Outcome|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
1120729|NCT00515099|O1|Outcome|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
1120730|NCT00515099|O2|Outcome|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
1120731|NCT00515099|O1|Outcome|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
1120732|NCT00515099|O2|Outcome|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
1120953|NCT00514813|P1|Participant Flow|Dynepo (Epoetin Delta) Twice Weekly (BIW)|Epoetin delta (Dynepo) dosed twice-a-week
1120733|NCT00515099|O1|Outcome|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
1120734|NCT00515099|O2|Outcome|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
1120735|NCT00515099|O1|Outcome|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
1120736|NCT00515099|O2|Outcome|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
1120737|NCT00515099|O1|Outcome|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
1120738|NCT00515099|O2|Outcome|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
1120739|NCT00515099|O1|Outcome|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
1120740|NCT00515099|E2|Reported Event|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4 2 mg/kg.
1120815|NCT00515008|O1|Outcome|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
1120741|NCT00515099|E1|Reported Event|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4 2 mg/kg.
1120742|NCT00515086|B5|Baseline|Total|Total of all reporting groups
1120743|NCT00515086|B4|Baseline|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
1120744|NCT00515086|B3|Baseline|Everolimus 5 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
1120745|NCT00515086|B2|Baseline|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
1120746|NCT00515086|B1|Baseline|No Surgery (Everolimus 10 mg)|Participants with recurrent Glioblastoma Multiforme (GBM) not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity.
1120747|NCT00515086|P4|Participant Flow|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
1120748|NCT00515086|P3|Participant Flow|Everolimus 5 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
1120749|NCT00515086|P2|Participant Flow|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
1120750|NCT00515086|P1|Participant Flow|No Surgery (Everolimus 10 mg)|Participants with recurrent Glioblastoma Multiforme (GBM) not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity.
1120751|NCT00515086|O3|Outcome|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
1120752|NCT00515086|O2|Outcome|Everolimus 5 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
1120753|NCT00515086|O1|Outcome|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
1120754|NCT00515086|O3|Outcome|Total : No Surgery|Total participants enrolled with recurrent glioblastoma multiforme (GBM) who were not scheduled to undergo a planned salvage surgical resection. All participants in this arm were to receive a fixed daily dose of 10 mg/day oral everolimus.
1120755|NCT00515086|O2|Outcome|No Surgery ( ≥ 2 Previous Relapses)|Participants with recurrent Glioblastoma Multiforme (GBM) with ≥ 2 previous relapses not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus until evidence of disease progression or toxicity.
1120756|NCT00515086|O1|Outcome|No Surgery (1 Previous Relapse)|Participants with recurrent Glioblastoma Multiforme (GBM) with 1 previous relapse not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity.
1120757|NCT00515086|O3|Outcome|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
1132989|NCT00479466|E2|Reported Event|MK0893 20 mg|
1120758|NCT00515086|O2|Outcome|Everolimus 5mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
1120759|NCT00515086|O1|Outcome|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
1120760|NCT00515086|O4|Outcome|Total|All the participants scheduled to undergo salvage surgical resection from three pre-surgery treatment groups (i.e 0, 5 or 10 mg/day (once daily) everolimus X 7 days).
1120761|NCT00515086|O3|Outcome|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
1120762|NCT00515086|O2|Outcome|Everolimus 5 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
1120763|NCT00515086|O1|Outcome|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
1120764|NCT00515086|O3|Outcome|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
1120816|NCT00515008|O2|Outcome|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
1120765|NCT00515086|O2|Outcome|Everolimus 5 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
1120766|NCT00515086|O1|Outcome|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
1120767|NCT00515086|O2|Outcome|No Surgery ( ≥ 2 Previous Relapses)|Participants with recurrent Glioblastoma Multiforme with ≥ 2 previous relapses not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus until evidence of disease progression or toxicity.
1120768|NCT00515086|O1|Outcome|No Surgery (1 Previous Relapse)|Participants with recurrent Glioblastoma Multiforme (GBM) with 1 previous relapse not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity.
1120769|NCT00515086|O3|Outcome|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
1120770|NCT00515086|O2|Outcome|Everolimus 5 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
1120771|NCT00515086|O1|Outcome|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
1120772|NCT00515086|E4|Reported Event|No Surgery (Everolimus 10 mg)|Participants with recurrent Glioblastoma Multiforme (GBM) not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity.
1120773|NCT00515086|E3|Reported Event|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
1120774|NCT00515086|E2|Reported Event|Everolimus 5 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
1120775|NCT00515086|E1|Reported Event|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
1120776|NCT00515073|B1|Baseline|Paclitaxel (Taxol) + Pelvic Radiation|"Paclitaxel (Taxol) 50 mg/m^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments.~Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.~Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy."
1120777|NCT00515073|P1|Participant Flow|Paclitaxel (Taxol) + Pelvic Radiation|"Paclitaxel (Taxol) 50 mg/m^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments.~Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.~Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy."
1120954|NCT00514813|O4|Outcome|Dynepo Once Every 4 Weeks (Q4W)|Epoetin delta dosed once every 4 weeks
1120778|NCT00515073|O1|Outcome|Paclitaxel (Taxol) + Pelvic Radiation|"Paclitaxel (Taxol) 50 mg/m^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments.~Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.~Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy."
1120779|NCT00515073|E1|Reported Event|Paclitaxel (Taxol) + Pelvic Radiation|"Paclitaxel (Taxol) 50 mg/m^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments.~Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.~Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy."
1120780|NCT00515034|B5|Baseline|Total|Total of all reporting groups
1120781|NCT00515034|B4|Baseline|cIAI Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
1120782|NCT00515034|B3|Baseline|cIAI Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
1120783|NCT00515034|B2|Baseline|VAP Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
1120784|NCT00515034|B1|Baseline|VAP Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
1120785|NCT00515034|P4|Participant Flow|cIAI Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
1120786|NCT00515034|P3|Participant Flow|cIAI Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
1120787|NCT00515034|P2|Participant Flow|VAP Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
1120788|NCT00515034|P1|Participant Flow|VAP Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
1120789|NCT00515034|O4|Outcome|cIAI Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
1120790|NCT00515034|O3|Outcome|cIAI Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
1120791|NCT00515034|O2|Outcome|VAP Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
1120792|NCT00515034|O1|Outcome|VAP Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
1120793|NCT00515034|O4|Outcome|cIAI Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
1120794|NCT00515034|O3|Outcome|cIAI Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
1120795|NCT00515034|O2|Outcome|VAP Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
1120796|NCT00515034|O1|Outcome|VAP Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
1120797|NCT00515034|O4|Outcome|cIAI Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
1120798|NCT00515034|O3|Outcome|cIAI Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
1120799|NCT00515034|O2|Outcome|VAP Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
1120800|NCT00515034|O1|Outcome|VAP Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
1120801|NCT00515034|E4|Reported Event|cIAI Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
1120802|NCT00515034|E3|Reported Event|cIAI Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
1120803|NCT00515034|E2|Reported Event|VAP Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
1120804|NCT00515034|E1|Reported Event|VAP Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
1120805|NCT00515008|B3|Baseline|Total|Total of all reporting groups
1120806|NCT00515008|B2|Baseline|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
1120807|NCT00515008|B1|Baseline|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
1120853|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 / Afatinib 50 mg|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
1120808|NCT00515008|P2|Participant Flow|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program. Our wellness education and stretching program similarly included 60-minute sessions held twice a week for 12 weeks. At each session, a variety of health professionals provided a 40-minute didactic lesson on a topic relating to fibromyalgia, including the diagnostic criteria; coping strategies and problem-solving techniques; diet and nutrition; sleep disorders and fibromyalgia; pain management, therapies, and medications; physical and mental health; exercise; and wellness and lifestyle management. For the final 20 minutes of each class, participants practiced stretching exercises supervised by the research staff. Stretches involved the upper body, trunk, and lower body and were held for 15 to 20 seconds. Participants were instructed to practice stretching at home for 20 minutes a day.
1120809|NCT00515008|P1|Participant Flow|Tai Chi Group|12-week Tai Chi Program.: The tai chi intervention took place twice a week for 12 weeks, and each session lasted for 60 minutes. Classes were taught by a tai chi master with more than 20 years of teaching experience. In the first session, he explained the theory behind tai chi and its procedures and provided participants with printed materials on its principles and techniques. In subsequent sessions, participants practiced 10 forms from the classic Yang style of tai chi under his instruction. Each session included a warm-up and self-massage, followed by a review of principles, movements, breathing techniques, and relaxation in tai chi. Throughout the intervention period, participants were instructed to practice tai chi at home for at least 20 minutes each day. At the end of the 12-week intervention, participants were encouraged to maintain their tai chi practice, using an instructional DVD, up until the follow-up visit at 24 weeks.
1120810|NCT00515008|O2|Outcome|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
1120811|NCT00515008|O1|Outcome|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
1133079|NCT00479336|E4|Reported Event|OPC-41061 30 mg|30 mg, 1 tablet a day
1120822|NCT00515008|O2|Outcome|Control Group|"Our wellness education and stretching program similarly included 60-minute sessions held twice a week for 12 weeks.19 At each session, a variety of health professionals provided a 40-minute didactic lesson on a topic relating to fibromyal- gia, including the diagnostic criteria; coping strat- egies and problem-solving techniques; diet and nutrition; sleep disorders and fibromyalgia; pain management, therapies, and medications; physi- cal and mental health; exercise; and wellness and~lifestyle management.20 For the final 20 minutes of each class, participants practiced stretching ex- ercises supervised by the research staff. Stretches involved the upper body, trunk, and lower body and were held for 15 to 20 seconds. Participants were instructed to practice stretching at home for 20 minutes a day."
1120823|NCT00515008|O1|Outcome|Tai Chi|The tai chi intervention took place twice a week for 12 weeks, and each session lasted for 60 min- utes. Classes were taught by a tai chi master with more than 20 years of teaching experience. In the first session, he explained the theory behind tai chi and its procedures and provided participants with printed materials on its principles and tech- niques. In subsequent sessions, participants prac- ticed 10 forms from the classic Yang style of tai chi18 under his instruction. Each session included a warm-up and self-massage, followed by a review of principles, movements, breathing techniques, and relaxation in tai chi. Throughout the inter- vention period, participants were instructed to practice tai chi at home for at least 20 minutes each day. At the end of the 12-week intervention, participants were encouraged to maintain their tai chi practice, using an instructional DVD, up until the follow-up visit at 24 weeks.
1120824|NCT00515008|O2|Outcome|Control Group|"Our wellness education and stretching program similarly included 60-minute sessions held twice a week for 12 weeks.19 At each session, a variety of health professionals provided a 40-minute didactic lesson on a topic relating to fibromyal- gia, including the diagnostic criteria; coping strat- egies and problem-solving techniques; diet and nutrition; sleep disorders and fibromyalgia; pain management, therapies, and medications; physi- cal and mental health; exercise; and wellness and~lifestyle management.20 For the final 20 minutes of each class, participants practiced stretching ex- ercises supervised by the research staff. Stretches involved the upper body, trunk, and lower body and were held for 15 to 20 seconds. Participants were instructed to practice stretching at home for 20 minutes a day."
1120825|NCT00515008|O1|Outcome|Tai Chi|"The tai chi intervention took place twice a week for 12 weeks, and each session lasted for 60 min- utes. Classes were taught by a tai chi master with more than 20 years of teaching experience. In the first session, he explained the theory behind tai~chi and its procedures and provided participants with printed materials on its principles and tech- niques. In subsequent sessions, participants prac- ticed 10 forms from the classic Yang style of tai chi18 under his instruction. Each session included a warm-up and self-massage, followed by a review of principles, movements, breathing techniques, and relaxation in tai chi. Throughout the inter- vention period, participants were instructed to practice tai chi at home for at least 20 minutes each day. At the end of the 12-week intervention, participants were encouraged to maintain their tai chi practice, using an instructional DVD, up until the follow-up visit at 24 weeks."
1120854|NCT00514943|O1|Outcome|Afatinib 50 mg / Cetuximab 250mg/m2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
1120883|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1.
1120826|NCT00515008|O2|Outcome|Control Group|"Our wellness education and stretching program similarly included 60-minute sessions held twice a week for 12 weeks.19 At each session, a variety of health professionals provided a 40-minute didactic lesson on a topic relating to fibromyal- gia, including the diagnostic criteria; coping strat- egies and problem-solving techniques; diet and nutrition; sleep disorders and fibromyalgia; pain management, therapies, and medications; physi- cal and mental health; exercise; and wellness and~lifestyle management.20 For the final 20 minutes of each class, participants practiced stretching ex- ercises supervised by the research staff. Stretches involved the upper body, trunk, and lower body and were held for 15 to 20 seconds. Participants were instructed to practice stretching at home for 20 minutes a day."
1120827|NCT00515008|O1|Outcome|Tai Chi|"The tai chi intervention took place twice a week for 12 weeks, and each session lasted for 60 min- utes. Classes were taught by a tai chi master with more than 20 years of teaching experience. In the first session, he explained the theory behind tai~chi and its procedures and provided participants with printed materials on its principles and tech- niques. In subsequent sessions, participants prac- ticed 10 forms from the classic Yang style of tai chi18 under his instruction. Each session included a warm-up and self-massage, followed by a review of principles, movements, breathing techniques, and relaxation in tai chi. Throughout the inter- vention period, participants were instructed to practice tai chi at home for at least 20 minutes each day. At the end of the 12-week intervention, participants were encouraged to maintain their tai chi practice, using an instructional DVD, up until the follow-up visit at 24 weeks."
1120828|NCT00515008|E2|Reported Event|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
1120829|NCT00515008|E1|Reported Event|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
1120830|NCT00514943|B3|Baseline|Total|Total of all reporting groups
1120831|NCT00514943|B2|Baseline|Cetuximab 250 mg/m2 / Afatinib 50 mg|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
1120832|NCT00514943|B1|Baseline|Afatinib 50 mg / Cetuximab 250mg/m2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
1120833|NCT00514943|P2|Participant Flow|Cetuximab 250 mg/m2 / Afatinib 50 mg|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
1120919|NCT00514852|B2|Baseline|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
1120920|NCT00514852|B1|Baseline|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
1120834|NCT00514943|P1|Participant Flow|Afatinib 50 mg / Cetuximab 250mg/m2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
1120835|NCT00514943|O3|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
1120836|NCT00514943|O2|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg in stage 1
1120837|NCT00514943|O1|Outcome|Afatinib 40 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1, and had sequential dose reduction to 40 mg in stage 1.
1120838|NCT00514943|O3|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
1120839|NCT00514943|O2|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg in stage 1
1120840|NCT00514943|O1|Outcome|Afatinib 40 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1, and had sequential dose reduction to 40 mg in stage 1.
1120841|NCT00514943|O2|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
1120842|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg in stage 1
1120843|NCT00514943|O4|Outcome|Cetuximab mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
1120844|NCT00514943|O3|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
1120845|NCT00514943|O2|Outcome|Cetuximab mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1
1120846|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg in stage 1
1120847|NCT00514943|O4|Outcome|Cetuximab mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
1120848|NCT00514943|O3|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
1120849|NCT00514943|O2|Outcome|Cetuximab mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1
1120850|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg in stage 1
1120884|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1.
1120855|NCT00514943|O2|Outcome|Cetuximab mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
1120856|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
1120857|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1.
1120858|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1.
1120859|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
1120860|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
1120861|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
1120862|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
1120863|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1.
1120864|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1.
1120865|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1.
1120866|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1.
1120867|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
1120868|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
1120869|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1.
1120870|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1.
1120871|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1.
1120872|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1.
1120873|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
1120874|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2.
1120875|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
1120876|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
1120877|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1.
1120878|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1.
1120879|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1.
1120880|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1.
1120881|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
1120882|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
1120948|NCT00514813|B2|Baseline|Dynepo Once Weekly (QW)|Epoetin delta dosed once-a-week
1132990|NCT00479466|E1|Reported Event|Placebo|
1120885|NCT00514943|E4|Reported Event|Afatinib 50 mg / Cetuximab 250mg/m2 - Stage 1|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
1120886|NCT00514943|E3|Reported Event|Cetuximab 250 mg/m2 / Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2.
1120887|NCT00514943|E2|Reported Event|Afatinib 50 mg / Cetuximab 250mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
1120888|NCT00514943|E1|Reported Event|Cetuximab 250 mg/m2 / Afatinib 50 mg - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2.
1120889|NCT00514917|B3|Baseline|Total|Total of all reporting groups
1120890|NCT00514917|B2|Baseline|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
1120891|NCT00514917|B1|Baseline|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
1120892|NCT00514917|P2|Participant Flow|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
1120893|NCT00514917|P1|Participant Flow|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
1120894|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
1121063|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1120895|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
1120896|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
1120897|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
1120898|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
1120899|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
1120900|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
1120901|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
1120902|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
1120903|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
1120904|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
1120905|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
1120906|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
1120907|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
1120908|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
1120949|NCT00514813|B1|Baseline|Dynepo (Epoetin Delta) Twice Weekly (BIW)|Epoetin delta (Dynepo) dosed twice-a-week
1120909|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
1120910|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
1120911|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
1120912|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg/m^2 subcutaneous injection for every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
1120913|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles along with leuprolide 22.5 mg/m^2subcutaneous injection for every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
1120914|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
1120915|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
1120916|NCT00514917|E2|Reported Event|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
1120917|NCT00514917|E1|Reported Event|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
1120918|NCT00514852|B3|Baseline|Total|Total of all reporting groups
1133080|NCT00479336|E3|Reported Event|OPC-41061 15 mg|15 mg, 1 tablet a day
1120921|NCT00514852|P2|Participant Flow|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
1120922|NCT00514852|P1|Participant Flow|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
1120923|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
1120924|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
1120925|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
1120926|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
1120927|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
1120928|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
1120929|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
1120930|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
1120931|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
1120932|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
1120933|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
1120934|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
1120935|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
1120936|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
1120937|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
1120938|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
1120939|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
1120940|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
1120941|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
1120942|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
1120943|NCT00514852|E2|Reported Event|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
1120944|NCT00514852|E1|Reported Event|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
1120945|NCT00514813|B5|Baseline|Total|Total of all reporting groups
1120946|NCT00514813|B4|Baseline|Dynepo Once Every 4 Weeks (Q4W)|Epoetin delta dosed once every 4 weeks
1120947|NCT00514813|B3|Baseline|Dynepo Once Every 2 Weeks (Q2W)|Epoetin delta dosed once every 2 weeks
1132991|NCT00479401|B4|Baseline|Total|Total of all reporting groups
1120957|NCT00514813|O1|Outcome|Dynepo (Epoetin Delta) Twice Weekly (BIW)|Epoetin delta (Dynepo) dosed twice-a-week
1120958|NCT00514813|O4|Outcome|Dynepo Once Every 4 Weeks (Q4W)|Epoetin delta dosed once every 4 weeks
1120959|NCT00514813|O3|Outcome|Dynepo Once Every 2 Weeks (Q2W)|Epoetin delta dosed once every 2 weeks
1120960|NCT00514813|O2|Outcome|Dynepo Once Weekly (QW)|Epoetin delta dosed once-a-week
1120961|NCT00514813|O1|Outcome|Dynepo (Epoetin Delta) Twice Weekly (BIW)|Epoetin delta (Dynepo) dosed twice-a-week
1120962|NCT00514813|O4|Outcome|Dynepo Once Every 4 Weeks (Q4W)|Epoetin delta dosed once every 4 weeks
1120963|NCT00514813|O3|Outcome|Dynepo Once Every 2 Weeks (Q2W)|Epoetin delta dosed once every 2 weeks
1120964|NCT00514813|O2|Outcome|Dynepo Once Weekly (QW)|Epoetin delta dosed once-a-week
1120965|NCT00514813|O1|Outcome|Dynepo (Epoetin Delta) Twice Weekly (BIW)|Epoetin delta (Dynepo) dosed twice-a-week
1120966|NCT00514813|E4|Reported Event|Dynepo Once Every 4 Weeks (Q4W)|Epoetin delta dosed once every 4 weeks
1120967|NCT00514813|E3|Reported Event|Dynepo Once Every 2 Weeks (Q2W)|Epoetin delta dosed once every 2 weeks
1120968|NCT00514813|E2|Reported Event|Dynepo Once Weekly (QW)|Epoetin delta dosed once-a-week
1120969|NCT00514813|E1|Reported Event|Dynepo (Epoetin Delta) Twice Weekly (BIW)|Epoetin delta (Dynepo) dosed twice-a-week
1120970|NCT00514735|B3|Baseline|Total|Total of all reporting groups
1120971|NCT00514735|B2|Baseline|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
1120972|NCT00514735|B1|Baseline|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
1121064|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1120973|NCT00514735|P2|Participant Flow|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
1120974|NCT00514735|P1|Participant Flow|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
1120975|NCT00514735|O2|Outcome|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
1120976|NCT00514735|O1|Outcome|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
1120977|NCT00514735|O2|Outcome|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
1120978|NCT00514735|O1|Outcome|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
1121034|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121035|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1120979|NCT00514735|O2|Outcome|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
1120980|NCT00514735|O1|Outcome|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
1120981|NCT00514735|O2|Outcome|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
1120982|NCT00514735|O1|Outcome|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
1120983|NCT00514735|O1|Outcome|Ablation Management|
1121065|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1133317|NCT00478192|O3|Outcome|Regimen 3 Placebo|
1120984|NCT00514735|O2|Outcome|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
1120985|NCT00514735|O1|Outcome|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
1120986|NCT00514735|O1|Outcome|Ablation Management|
1120987|NCT00514735|O2|Outcome|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
1120988|NCT00514735|O1|Outcome|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
1120989|NCT00514735|E2|Reported Event|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
1120990|NCT00514735|E1|Reported Event|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
1120991|NCT00514709|B3|Baseline|Total|Total of all reporting groups
1121036|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121037|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1120992|NCT00514709|B2|Baseline|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
1120993|NCT00514709|B1|Baseline|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
1120994|NCT00514709|P2|Participant Flow|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201 (NCT00348881).
1120995|NCT00514709|P1|Participant Flow|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201 (NCT00348881).
1120996|NCT00514709|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
1120997|NCT00514709|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
1120998|NCT00514709|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine following a 3-dose primary series of Tritanrix-Hep B/ Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
1120999|NCT00514709|O1|Outcome|Group 1: DTaP-Hep B-PRP-T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine following a 3-dose primary series of DTaP-Hep B-PRP-T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
1121000|NCT00514709|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
1121001|NCT00514709|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
1121002|NCT00514709|E2|Reported Event|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
1121003|NCT00514709|E1|Reported Event|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
1121004|NCT00514683|B6|Baseline|Total|Total of all reporting groups
1121005|NCT00514683|B5|Baseline|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121006|NCT00514683|B4|Baseline|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121007|NCT00514683|B3|Baseline|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121008|NCT00514683|B2|Baseline|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121009|NCT00514683|B1|Baseline|Placebo|Patients were treated with matching Placebo.
1121010|NCT00514683|P5|Participant Flow|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121011|NCT00514683|P4|Participant Flow|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121012|NCT00514683|P3|Participant Flow|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121013|NCT00514683|P2|Participant Flow|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121014|NCT00514683|P1|Participant Flow|Placebo|Patients were treated with matching Placebo.
1121015|NCT00514683|O4|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121016|NCT00514683|O3|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121017|NCT00514683|O2|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121018|NCT00514683|O1|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121019|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121020|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121021|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121022|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121023|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121024|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121025|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121026|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121027|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121028|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121029|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121030|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121031|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121032|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121033|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121038|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121039|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121040|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121041|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121042|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121043|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121044|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121045|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121046|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121047|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121048|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121049|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121050|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121051|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121052|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121053|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121054|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121055|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121056|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121057|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121058|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121059|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121060|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121061|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121062|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121066|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121067|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121068|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121069|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121070|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121071|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121072|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121073|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121074|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121075|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121076|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121077|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121078|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121079|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121080|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121081|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121082|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121083|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121084|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121085|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121086|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121087|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121088|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121089|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121090|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121091|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121092|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121093|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121094|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121095|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121096|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121097|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121098|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121099|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121100|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121101|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121102|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121103|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121104|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121105|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121106|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121107|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121108|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121109|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121110|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121111|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121112|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121113|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121114|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121115|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121116|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121117|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121118|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121119|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121120|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121121|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121122|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121123|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121124|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121125|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121126|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121127|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121128|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121129|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121130|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121131|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121132|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121133|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121134|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121135|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121136|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121137|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121138|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121139|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121140|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121141|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121142|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121143|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121144|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121145|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121146|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121147|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121148|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121149|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121150|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121151|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121152|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121153|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121154|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121155|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121156|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121157|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121158|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121159|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121160|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121161|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121162|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121163|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121164|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121165|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121166|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121167|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121168|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121169|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121170|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121171|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121172|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121173|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121174|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121175|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121176|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121177|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121178|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121179|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121180|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121181|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121182|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121183|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121184|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121185|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121186|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121187|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121188|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121189|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121190|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121191|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121192|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121193|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121194|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121195|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121196|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121197|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121198|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
1121199|NCT00514683|E5|Reported Event|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
1121200|NCT00514683|E4|Reported Event|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
1121201|NCT00514683|E3|Reported Event|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
1121202|NCT00514683|E2|Reported Event|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
1121203|NCT00514683|E1|Reported Event|Placebo|Patients were treated with matching Placebo.
1121204|NCT00514592|B1|Baseline|All Patients|All patients are in the same group
1121205|NCT00514592|P1|Participant Flow|All Patients|All patients enter the same group
1121206|NCT00514592|O1|Outcome|All Patients|All patients enter the same group
1121207|NCT00514592|O1|Outcome|All Patients|All patients enter the same group
1121208|NCT00514592|E1|Reported Event|All Patients|All patients enter the same group
1121209|NCT00514514|B4|Baseline|Total|Total of all reporting groups
1121210|NCT00514514|B3|Baseline|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
1121211|NCT00514514|B2|Baseline|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
1121212|NCT00514514|B1|Baseline|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
1121213|NCT00514514|P3|Participant Flow|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
1121214|NCT00514514|P2|Participant Flow|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
1121215|NCT00514514|P1|Participant Flow|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
1121216|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
1121217|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
1121218|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
1121350|NCT00513617|O1|Outcome|Low Dose|0.05 g/kg/day of Arginine in capsule form
1121351|NCT00513617|O3|Outcome|Placebo|
1135319|NCT00473642|O3|Outcome|Ranibizumab|Ranibizumab monotherapy
1121219|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
1121220|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
1121221|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
1121222|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
1121223|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
1121224|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
1121225|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
1121226|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
1121227|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
1121228|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
1121229|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
1121230|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
1121231|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
1133714|NCT00477269|O2|Outcome|Placebo|Placebo
1121232|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
1121233|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
1121234|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
1121235|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
1121236|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
1121237|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
1121238|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
1121239|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
1121240|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
1121241|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
1121242|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
1121243|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
1121244|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
1121245|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
1121246|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
1121247|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
1121248|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
1121249|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
1121250|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
1121251|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
1121252|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
1121253|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
1121254|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
1121255|NCT00514514|E3|Reported Event|CNI-low|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Certican 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: Certican 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
1121256|NCT00514514|E2|Reported Event|CNI-free|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, Certican 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, Certican 3 mg and corticosteroids"
1121257|NCT00514514|E1|Reported Event|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
1121258|NCT00514501|B1|Baseline|Iodofiltic Acid I 123|A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
1121259|NCT00514501|P1|Participant Flow|Iodofiltic Acid I 123|A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
1121260|NCT00514501|O1|Outcome|Iodofiltic Acid I 123|A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
1121261|NCT00514501|O1|Outcome|Iodofiltic Acid I 123|A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
1121262|NCT00514501|O1|Outcome|Iodofiltic Acid I 123|A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
1133715|NCT00477269|O1|Outcome|STI571|STI571
1121263|NCT00514501|E1|Reported Event|Iodofiltic Acid I 123|A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
1121264|NCT00514215|B1|Baseline|Sargramostim, Flow Cytometry, Biopsy. Cryosurgery|"Sargramostim-250 μg, inhaled, two times a day, on days 4-10 and days 36-42 Flow cytometry-Days 1 & 32 Immunoenzyme technique-Days 1 & 32 CT guided biopsy-Days 1 & 32 Cryosurgery-Days 1 and 32~sargramostim: 250 μg, inhaled, two times a day, on days 4-10 and days 36-42~flow cytometry: Days 1 & 32~immunoenzyme technique: Days 1 & 32~biopsy: CT guided biopsy on days 1 & 32~cryosurgery: Days 1 and 32"
1121265|NCT00514215|P1|Participant Flow|Sargramostim, Flow Cytometry, Biopsy. Cryosurgery|"Sargramostim-250 μg, inhaled, two times a day, on days 4-10 and days 36-42 Flow cytometry-Days 1 & 32 Immunoenzyme technique-Days 1 & 32 CT guided biopsy-Days 1 & 32 Cryosurgery-Days 1 and 32~sargramostim: 250 μg, inhaled, two times a day, on days 4-10 and days 36-42~flow cytometry: Days 1 & 32~immunoenzyme technique: Days 1 & 32~biopsy: CT guided biopsy on days 1 & 32~cryosurgery: Days 1 and 32"
1121266|NCT00514215|O1|Outcome|Sargramostim, Flow Cytometry, Biopsy. Cryosurgery|"Sargramostim-250 μg, inhaled, two times a day, on days 4-10 and days 36-42 Flow cytometry-Days 1 & 32 Immunoenzyme technique-Days 1 & 32 CT guided biopsy-Days 1 & 32 Cryosurgery-Days 1 and 32~sargramostim: 250 μg, inhaled, two times a day, on days 4-10 and days 36-42~flow cytometry: Days 1 & 32~immunoenzyme technique: Days 1 & 32~biopsy: CT guided biopsy on days 1 & 32~cryosurgery: Days 1 and 32"
1121267|NCT00514215|E1|Reported Event|Sargramostim, Flow Cytometry, Biopsy. Cryosurgery|"Sargramostim-250 μg, inhaled, two times a day, on days 4-10 and days 36-42 Flow cytometry-Days 1 & 32 Immunoenzyme technique-Days 1 & 32 CT guided biopsy-Days 1 & 32 Cryosurgery-Days 1 and 32~sargramostim: 250 μg, inhaled, two times a day, on days 4-10 and days 36-42~flow cytometry: Days 1 & 32~immunoenzyme technique: Days 1 & 32~biopsy: CT guided biopsy on days 1 & 32~cryosurgery: Days 1 and 32"
1121268|NCT00514137|B1|Baseline|Treatment (Kinase Inhibitor Therapy)|Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1121269|NCT00514137|P1|Participant Flow|Treatment (Kinase Inhibitor Therapy)|Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1121270|NCT00514137|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1121271|NCT00514137|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1121272|NCT00514137|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1121273|NCT00514137|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1121274|NCT00514137|E1|Reported Event|Treatment (Kinase Inhibitor Therapy)|Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1121275|NCT00514020|B1|Baseline|Oxaliplatin + Leucovorin + 5-Fluorouracil|Patients receive oxaliplatin IV over 2 hours, leucovorin calcium intravenously (IV) over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
1136154|NCT00470600|O1|Outcome|Placebo|250 mL of normal saline.
1121276|NCT00514020|P1|Participant Flow|5-FU, Leucovorin, Oxaliplatin|"Patients who have TSER*2/*2 or TSER*2/*3 genotypes will receive the modified FOLFOX-6 treatment. Patients homozygous for TSER*3 will not be included in study.~FOLFOX-6 chemotherapy: oxaliplatin IV in 500 ml D5W over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15.~Treatment courses repeat every 2 weeks +/- 3 days (2 treatments per cycle) in the absence of unacceptable toxicity or disease progression. Disease assessments will be performed after 8 weeks (2 cycles) of treatment."
1121277|NCT00514020|O1|Outcome|Oxaliplatin + Leucovorin + 5-Fluorouracil|Patients receive oxaliplatin IV over 2 hours, leucovorin calcium intravenously (IV) over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
1121278|NCT00514020|E1|Reported Event|Oxaliplatin + Leucovorin + 5-Fluorouracil|Patients receive oxaliplatin IV over 2 hours, leucovorin calcium intravenously (IV) over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
1121279|NCT00513799|B5|Baseline|Total|Total of all reporting groups
1121280|NCT00513799|B4|Baseline|Education + Mupirocin + Bleach Baths|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed bleach bath to entire body once daily for 5 days (instructed to pour 2 ounces of bleach into water-filled bath tub and soak in bath for 15 minutes).
1121281|NCT00513799|B3|Baseline|Education + Mupirocin + Chlorhexidine|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed Chlorhexidine wash to entire body once daily for 5 days.
1121282|NCT00513799|B2|Baseline|Hygiene Education + Mupirocin|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days
1121283|NCT00513799|B1|Baseline|Hygiene Education|"Participants only administered an intensive education on prevention of skin infections through improvements in personal hygiene (also serves as control group)"
1121399|NCT00513500|B2|Baseline|Current Practice|"Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Refer children with pneumonia to the nearest health facility."
1121284|NCT00513799|P4|Participant Flow|Education + Mupirocin + Bleach Baths|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed bleach bath to entire body once daily for 5 days (instructed to pour 2 ounces of bleach into water-filled bath tub and soak in bath for 15 minutes).
1121285|NCT00513799|P3|Participant Flow|Education + Mupirocin + Chlorhexidine|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed Chlorhexidine wash to entire body once daily for 5 days.
1121286|NCT00513799|P2|Participant Flow|Hygiene Education + Mupirocin|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days
1121287|NCT00513799|P1|Participant Flow|Hygiene Education|"Participants only administered an intensive education on prevention of skin infections through improvements in personal hygiene (also serves as control group)"
1121288|NCT00513799|O4|Outcome|4: Education + Mupirocin + Bleach Baths|"A combination of nasal application of mupirocin and bathing in dilute bleach water~Mupirocin ointment: Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.~Bleach baths (dilute): Pour 2 ounces of bleach into water-filled bath tub. Soak in bath for 15 minutes. Apply once daily for 5 days.~Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
1121289|NCT00513799|O3|Outcome|Education + Mupirocin + Chlorhexidine|"A combination of nasal application of mupirocin and chlorhexidine showers~Mupirocin ointment: Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.~Chlorhexidine showers: Apply Clorhexidine wash to entire body once daily for 5 days.~Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
1121290|NCT00513799|O2|Outcome|2: Hygiene Education + Mupirocin|"Application of mupirocin in the nasal mucosa alone~Mupirocin ointment: Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.~Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
1121291|NCT00513799|O1|Outcome|1: Hygiene Education|"Intensive education on prevention of skin infections through improvements in personal hygiene (also serves as control group)~Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
1121292|NCT00513799|O4|Outcome|4: Education + Mupirocin + Bleach Baths|"A combination of nasal application of mupirocin and bathing in dilute bleach water~Mupirocin ointment: Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.~Bleach baths (dilute): Pour 2 ounces of bleach into water-filled bath tub. Soak in bath for 15 minutes. Apply once daily for 5 days.~Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
1121293|NCT00513799|O3|Outcome|Education + Mupirocin + Chlorhexidine|"A combination of nasal application of mupirocin and chlorhexidine showers~Mupirocin ointment: Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.~Chlorhexidine showers: Apply Clorhexidine wash to entire body once daily for 5 days.~Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
1121294|NCT00513799|O2|Outcome|2: Hygiene Education + Mupirocin|"Application of mupirocin in the nasal mucosa alone~Mupirocin ointment: Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.~Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
1121295|NCT00513799|O1|Outcome|1: Hygiene Education|"Intensive education on prevention of skin infections through improvements in personal hygiene (also serves as control group)~Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
1136411|NCT00469079|O3|Outcome|Snus|A spitless, oral tobacco pouch.
1121296|NCT00513799|O4|Outcome|Education + Mupirocin + Bleach Baths|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed bleach bath to entire body once daily for 5 days (instructed to pour 2 ounces of bleach into water-filled bath tub and soak in bath for 15 minutes).
1121297|NCT00513799|O3|Outcome|Education + Mupirocin + Chlorhexidine|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed Chlorhexidine wash to entire body once daily for 5 days.
1121298|NCT00513799|O2|Outcome|Hygiene Education + Mupirocin|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days
1121299|NCT00513799|O1|Outcome|Hygiene Education|"Participants only administered an intensive education on prevention of skin infections through improvements in personal hygiene (also serves as control group)"
1121300|NCT00513799|E4|Reported Event|Education + Mupirocin + Bleach Baths|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed bleach bath to entire body once daily for 5 days (instructed to pour 2 ounces of bleach into water-filled bath tub and soak in bath for 15 minutes).
1121301|NCT00513799|E3|Reported Event|Education + Mupirocin + Chlorhexidine|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed Chlorhexidine wash to entire body once daily for 5 days.
1121302|NCT00513799|E2|Reported Event|Hygiene Education + Mupirocin|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days
1121303|NCT00513799|E1|Reported Event|Hygiene Education|"Participants only administered an intensive education on prevention of skin infections through improvements in personal hygiene (also serves as control group)"
1121304|NCT00513708|B4|Baseline|Total|Total of all reporting groups
1121305|NCT00513708|B3|Baseline|Peer-delivered Twelve Step Facilitation|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Peer-delivered Twelve Step Facilitation (P-TSF)session delivered by individuals from a common self-help program."
1121306|NCT00513708|B2|Baseline|Motivational Enhancement Therapy|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Motivational Enhancement Therapy (MET) session delivered by a trained professional."
1121307|NCT00513708|B1|Baseline|Treatment as Usual|"Treatment as Usual (TAU): Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during medically managed inpatient detoxification."
1121308|NCT00513708|P3|Participant Flow|Peer-delivered Twelve Step Facilitation|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Peer-delivered Twelve Step Facilitation (P-TSF)session delivered by individuals from a common self-help program."
1121309|NCT00513708|P2|Participant Flow|Motivational Enhancement Therapy|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Motivational Enhancement Therapy (MET) session delivered by a trained professional."
1121310|NCT00513708|P1|Participant Flow|Treatment as Usual|"Treatment as Usual (TAU): Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during medically managed inpatient detoxification."
1121311|NCT00513708|O3|Outcome|Peer-delivered Twelve Step Facilitation|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Peer-delivered Twelve Step Facilitation (P-TSF)session delivered by individuals from a common self-help program."
1121312|NCT00513708|O2|Outcome|Motivational Enhancement Therapy|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Motivational Enhancement Therapy (MET) session delivered by a trained professional."
1121313|NCT00513708|O1|Outcome|Treatment as Usual|"Treatment as Usual (TAU): Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during medically managed inpatient detoxification."
1121314|NCT00513708|O3|Outcome|Peer-delivered Twelve Step Facilitation|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Peer-delivered Twelve Step Facilitation (P-TSF)session delivered by individuals from a common self-help program."
1121315|NCT00513708|O2|Outcome|Motivational Enhancement Therapy|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Motivational Enhancement Therapy (MET) session delivered by a trained professional."
1121316|NCT00513708|O1|Outcome|Treatment as Usual|"Treatment as Usual (TAU): Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during medically managed inpatient detoxification."
1121317|NCT00513708|O3|Outcome|Peer-delivered Twelve Step Facilitation|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Peer-delivered Twelve Step Facilitation (P-TSF)session delivered by individuals from a common self-help program."
1121352|NCT00513617|O2|Outcome|High Dose|0.10 g/kg/day of Arginine in capsule form
1121353|NCT00513617|O1|Outcome|Low Dose|0.05 g/kg/day of Arginine in capsule form
1121318|NCT00513708|O2|Outcome|Motivational Enhancement Therapy|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Motivational Enhancement Therapy (MET) session delivered by a trained professional."
1121319|NCT00513708|O1|Outcome|Treatment as Usual|"Treatment as Usual (TAU): Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during medically managed inpatient detoxification."
1121320|NCT00513708|E3|Reported Event|Peer-delivered Twelve Step Facilitation|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Peer-delivered Twelve Step Facilitation (P-TSF)session delivered by individuals from a common self-help program."
1121321|NCT00513708|E2|Reported Event|Motivational Enhancement Therapy|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Motivational Enhancement Therapy (MET) session delivered by a trained professional."
1121322|NCT00513708|E1|Reported Event|Treatment as Usual|"Treatment as Usual (TAU): Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during medically managed inpatient detoxification."
1121323|NCT00513695|B1|Baseline|Treatment (Neoadjuvant Chemotherapy Before Surgery)|"Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.~sunitinib malate: Given PO~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~filgrastim: Given SC~therapeutic conventional surgery: Undergo surgery~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies"
1121324|NCT00513695|P1|Participant Flow|Treatment (Neoadjuvant Chemotherapy Before Surgery)|"Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.~sunitinib malate: Given PO~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~filgrastim: Given SC~therapeutic conventional surgery: Undergo surgery~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies"
1121325|NCT00513695|O1|Outcome|Treatment (Neoadjuvant Chemotherapy Before Surgery)|"Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.~sunitinib malate: Given PO~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~filgrastim: Given SC~therapeutic conventional surgery: Undergo surgery~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies"
1121326|NCT00513695|O1|Outcome|Treatment (Neoadjuvant Chemotherapy Before Surgery)|"Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.~sunitinib malate: Given PO~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~filgrastim: Given SC~therapeutic conventional surgery: Undergo surgery~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies"
1121327|NCT00513695|O1|Outcome|Treatment (Neoadjuvant Chemotherapy Before Surgery)|"Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.~sunitinib malate: Given PO~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~filgrastim: Given SC~therapeutic conventional surgery: Undergo surgery~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies"
1121328|NCT00513695|O1|Outcome|Treatment (Neoadjuvant Chemotherapy Before Surgery)|"Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.~sunitinib malate: Given PO~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~filgrastim: Given SC~therapeutic conventional surgery: Undergo surgery~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies"
1121354|NCT00513617|O3|Outcome|Placebo|
1121355|NCT00513617|O2|Outcome|High Dose|0.10 g/kg/day of Arginine in capsule form
1121356|NCT00513617|O1|Outcome|Low Dose|0.05 g/kg/day of Arginine in capsule form
1121357|NCT00513604|B6|Baseline|Total|Total of all reporting groups
1122359|NCT00510809|B1|Baseline|Statin and Policosanol|20mg daily, double-blind
1121329|NCT00513695|O1|Outcome|Treatment (Neoadjuvant Chemotherapy Before Surgery)|"Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.~sunitinib malate: Given PO~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~filgrastim: Given SC~therapeutic conventional surgery: Undergo surgery~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies"
1121330|NCT00513695|O1|Outcome|Treatment (Neoadjuvant Chemotherapy Before Surgery)|"Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.~sunitinib malate: Given PO~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~filgrastim: Given SC~therapeutic conventional surgery: Undergo surgery~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies"
1121331|NCT00513695|E1|Reported Event|Treatment (Neoadjuvant Chemotherapy Before Surgery)|"Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.~sunitinib malate: Given PO~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given PO~filgrastim: Given SC~therapeutic conventional surgery: Undergo surgery~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies"
1121332|NCT00513682|B1|Baseline|Ultrase® MT20|Ultrase® MT20 capsules orally with each meal during Day 1 to 15 in screening phase at a dose based on investigator's discretion. During Day 12 to 15, participants received high-fat diet and Ultrase® MT20 dose was adjusted depending on symptoms of steatorrhea. This was followed by a washout phase of 6 to 7 days, in which participants received only high-fat diet. Then the treatment phase was started which consisted of a stabilized dose of Ultrase® MT20 capsule (as identified during screening phase) orally for 7 to 11 days. The stabilized dose not to exceed 2500 lipase units per kilogram body weight per meal (lipase units/kg/meal).
1121333|NCT00513682|P1|Participant Flow|Ultrase® MT20|Ultrase® MT20 capsules orally with each meal during Day 1 to 15 in screening phase at a dose based on investigator's discretion. During Day 12 to 15, participants received high-fat diet and Ultrase® MT20 dose was adjusted depending on symptoms of steatorrhea. This was followed by a washout phase of 6 to 7 days, in which participants received only high-fat diet. Then the treatment phase was started which consisted of a stabilized dose of Ultrase® MT20 capsule (as identified during screening phase) orally for 7 to 11 days. The stabilized dose not to exceed 2500 lipase units per kilogram body weight per meal (lipase units/kg/meal).
1121334|NCT00513682|O2|Outcome|Ultrase® MT20 Treatment Phase|Participants who received Ultrase® MT20 capsules orally in screening phase and underwent washout phase, received stabilized dose of Ultrase® MT20 capsule (as identified during screening phase) orally for 7 to 11 days during treatment phase. The stabilized dose not to exceed 2500 lipase units per kilogram body weight per meal (unit/kg/meal).
1121335|NCT00513682|O1|Outcome|Ultrase® MT20 Washout Phase|Ultrase® MT20 capsules orally with each meal during Day 1 to 15 in screening phase at a dose based on investigator's discretion. During Day 12 to 15, participants received high-fat diet and Ultrase® MT20 dose was adjusted depending on symptoms of steatorrhea. This was followed by a washout phase of 6 to 7 days, in which participants received only high-fat diet.
1121336|NCT00513682|O2|Outcome|Ultrase® MT20 Treatment Phase|Participants who received Ultrase® MT20 capsules orally in screening phase and underwent washout phase, received stabilized dose of Ultrase® MT20 capsule (as identified during screening phase) orally for 7 to 11 days during treatment phase. The stabilized dose not to exceed 2500 lipase units per kilogram body weight per meal (unit/kg/meal).
1121337|NCT00513682|O1|Outcome|Ultrase® MT20 Washout Phase|Ultrase® MT20 capsules orally with each meal during Day 1 to 15 in screening phase at a dose based on investigator's discretion. During Day 12 to 15, participants received high-fat diet and Ultrase® MT20 dose was adjusted depending on symptoms of steatorrhea. This was followed by a washout phase of 6 to 7 days, in which participants received only high-fat diet.
1121338|NCT00513682|E3|Reported Event|Ultrase® MT20 Treatment Phase|Participants who received Ultrase® MT20 capsules orally in screening phase and underwent washout phase, received stabilized dose of Ultrase® MT20 capsule (as identified during screening phase) orally for 7 to 11 days during treatment phase. The stabilized dose not to exceed 2500 lipase units per kilogram body weight per meal (unit/kg/meal).
1121339|NCT00513682|E2|Reported Event|Ultrase® MT20 Washout Phase|Participants who received Ultrase® MT20 capsules orally in screening phase and underwent a washout phase, of 6 to 7 days, in which participants received only high-fat diet and refrained from taking Ultrase® MT20.
1121340|NCT00513682|E1|Reported Event|Ultrase® MT20 Screening Phase|Ultrase® MT20 capsules orally with each meal during Day 1 to 15 in screening phase at a dose based on investigator's discretion. During Day 12 to 15, participants received high-fat diet and Ultrase® MT20 dose was adjusted depending on symptoms of steatorrhea.
1121341|NCT00513617|B4|Baseline|Total|Total of all reporting groups
1121342|NCT00513617|B3|Baseline|Placebo|
1121343|NCT00513617|B2|Baseline|High Dose|0.10 g/kg/day of Arginine in capsule form
1121344|NCT00513617|B1|Baseline|Low Dose|0.05 g/kg/day of Arginine in capsule form
1121345|NCT00513617|P3|Participant Flow|Placebo|
1121346|NCT00513617|P2|Participant Flow|High Dose|0.10 g/kg/day of Arginine in capsule form
1121347|NCT00513617|P1|Participant Flow|Low Dose|0.05 g/kg/day of Arginine in capsule form
1121348|NCT00513617|O3|Outcome|Placebo|
1121349|NCT00513617|O2|Outcome|High Dose|0.10 g/kg/day of Arginine in capsule form
1121358|NCT00513604|B5|Baseline|Cohort 5 - NMA, CD4+TIL, HD Aldesleukin|"Cohort 5 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) tumor infiltrating lymphocytes (TIL), high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days"
1121359|NCT00513604|B4|Baseline|Cohort 4 - NMA, Young TIL, Aldesleukin|"Cohort 4 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
1121360|NCT00513604|B3|Baseline|Cohort 3 - NMA, Total Body Irradiation|"Cohort 3 - Nonmyeloablative (NMA), total body irradiation (TBI):~Nonmyeloablative chemotherapeutic conditioning regimen and 2 gray units (Gy) of total body irradiation followed by cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL 2Gy (gray units) of total body irradiation (TBI) twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute using a linear accelerator in Radiation Oncology Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
1121361|NCT00513604|B2|Baseline|Cohort 2 - NMA, CD4+ TIL, Aldesleukin|"Cohort 2 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
1121471|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
1121472|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
1121362|NCT00513604|B1|Baseline|Cohort 1 - NMA, TIL, Aldesleukin|"Cohort 1 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), & high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
1121363|NCT00513604|P5|Participant Flow|Cohort 5 - NMA, CD4+TIL, HD Aldesleukin|"Cohort 5 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) tumor infiltrating lymphocytes (TIL), high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days"
1121364|NCT00513604|P4|Participant Flow|Cohort 4 - NMA, Young TIL, Aldesleukin|"Cohort 4 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
1121365|NCT00513604|P3|Participant Flow|Cohort 3 - NMA, Total Body Irradiation|"Cohort 3 - Nonmyeloablative (NMA), total body irradiation (TBI):~Nonmyeloablative chemotherapeutic conditioning regimen and 2 gray units (Gy) of total body irradiation followed by cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL 2Gy (gray units) of total body irradiation (TBI) twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute using a linear accelerator in Radiation Oncology Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
1121366|NCT00513604|P2|Participant Flow|Cohort 2 - NMA, CD4+ TIL, Aldesleukin|"Cohort 2 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
1121367|NCT00513604|P1|Participant Flow|Cohort 1 - NMA, TIL, Aldesleukin|"Cohort 1 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), & high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
1121368|NCT00513604|O5|Outcome|Cohort 5 - NMA, CD4+TIL, HD Aldesleukin|"Cohort 5 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) tumor infiltrating lymphocytes (TIL), high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days"
1121369|NCT00513604|O4|Outcome|Cohort 4 - NMA, Young TIL, Aldesleukin|"Cohort 4 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
1121454|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
1122360|NCT00510809|P3|Participant Flow|Policosanol|20 mg daily, open label
1121370|NCT00513604|O3|Outcome|Cohort 3 - NMA, Total Body Irradiation|"Cohort 3 - Nonmyeloablative (NMA), total body irradiation (TBI):~Nonmyeloablative chemotherapeutic conditioning regimen and 2 gray units (Gy) of total body irradiation followed by cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL 2Gy (gray units) of total body irradiation (TBI) twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute using a linear accelerator in Radiation Oncology Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
1121371|NCT00513604|O2|Outcome|Cohort 2 - NMA, CD4+ TIL, Aldesleukin|"Cohort 2 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
1121372|NCT00513604|O1|Outcome|Cohort 1 - NMA, TIL, Aldesleukin|"Cohort 1 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), & high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
1121373|NCT00513604|O5|Outcome|Cohort 5 - NMA, CD4+TIL, HD Aldesleukin|"Cohort 5 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) tumor infiltrating lymphocytes (TIL), high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days"
1121374|NCT00513604|O4|Outcome|Cohort 4 - NMA, Young TIL, Aldesleukin|"Cohort 4 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
1121375|NCT00513604|O3|Outcome|Cohort 3 - NMA, Total Body Irradiation|"Cohort 3 - Nonmyeloablative (NMA), total body irradiation (TBI):~Nonmyeloablative chemotherapeutic conditioning regimen and 2 gray units (Gy) of total body irradiation followed by cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL 2Gy (gray units) of total body irradiation (TBI) twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute using a linear accelerator in Radiation Oncology Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
1121376|NCT00513604|O2|Outcome|Cohort 2 - NMA, CD4+ TIL, Aldesleukin|"Cohort 2 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
1121377|NCT00513604|O1|Outcome|Cohort 1 - NMA, TIL, Aldesleukin|"Cohort 1 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), & high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
1121378|NCT00513604|E5|Reported Event|Cohort 5 - NMA, CD4+TIL, HD Aldesleukin|"Cohort 5 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) tumor infiltrating lymphocytes (TIL), high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days"
1121379|NCT00513604|E4|Reported Event|Cohort 4 - NMA, Young TIL, Aldesleukin|"Cohort 4 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
1121380|NCT00513604|E3|Reported Event|Cohort 3 - NMA, Total Body Irradiation|"Cohort 3 - Nonmyeloablative (NMA), total body irradiation (TBI):~Nonmyeloablative chemotherapeutic conditioning regimen and 2 gray units (Gy) of total body irradiation followed by cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL 2Gy (gray units) of total body irradiation (TBI) twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute using a linear accelerator in Radiation Oncology Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
1121381|NCT00513604|E2|Reported Event|Cohort 2 - NMA, CD4+ TIL, Aldesleukin|"Cohort 2 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
1121503|NCT00513344|O2|Outcome|Milk Chocolate Containing Polyphenols|"Bespoke milk chocolate~Milk Chocolate : 1 portion"
1121382|NCT00513604|E1|Reported Event|Cohort 1 - NMA, TIL, Aldesleukin|"Cohort 1 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), & high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
1121383|NCT00513526|B1|Baseline|Gardasil|Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.
1121384|NCT00513526|P1|Participant Flow|Gardasil|Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.
1121385|NCT00513526|O1|Outcome|Gardasil|Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.
1121386|NCT00513526|O1|Outcome|Gardasil|
1121387|NCT00513526|O1|Outcome|Gardasil|
1121388|NCT00513526|O1|Outcome|Gardasil|
1121389|NCT00513526|O1|Outcome|Gardasil|Number of participants seropositive for HPV-6 at week 28 among those who were seronegative at baseline.
1121390|NCT00513526|O1|Outcome|Gardasil|Number of participants seropositive for HPV-6 at week 28 among those who were seronegative at baseline.
1121391|NCT00513526|O1|Outcome|Gardasil|Number of participants seropositive for HPV-6 at week 28 among those who were seronegative at baseline.
1121392|NCT00513526|O1|Outcome|Gardasil|
1121393|NCT00513526|O1|Outcome|Gardasil|
1121394|NCT00513526|O1|Outcome|Gardasil|
1121395|NCT00513526|O1|Outcome|Gardasil|Number of participants seropositive for HPV-6 at week 28 among those who were seronegative at baseline.
1121396|NCT00513526|O1|Outcome|Gardasil|
1121397|NCT00513526|E1|Reported Event|Gardasil|Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.
1121398|NCT00513500|B3|Baseline|Total|Total of all reporting groups
1133716|NCT00477269|O2|Outcome|Placebo|Placebo
1121400|NCT00513500|B1|Baseline|Enhanced Treatment|"Intervention: Treatment for malaria and pneumonia:~Treat malaria based on rapid diagnostic test with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Treat pneumonia with half tablet (250mg amoxicillin) for children weighing 5 - 9.9kg and one tablet (250mg amoxicillin for children weighing 10-20kg three times a day for five days."
1121401|NCT00513500|P2|Participant Flow|Current Practice|"Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Refer children with pneumonia to the nearest health facility."
1121402|NCT00513500|P1|Participant Flow|Enhanced Treatment|"Intervention: Treatment for malaria and pneumonia:~Treat malaria based on rapid diagnostic test with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Treat pneumonia with half tablet (250mg amoxicillin) for children weighing 5 - 9.9kg and one tablet (250mg amoxicillin for children weighing 10-20kg three times a day for five days."
1121403|NCT00513500|O2|Outcome|Current Practice|"Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Refer children with pneumonia to the nearest health facility."
1121404|NCT00513500|O1|Outcome|Enhanced Treatment|"Intervention: Treatment for malaria and pneumonia:~Treat malaria based on rapid diagnostic test with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Treat pneumonia with half tablet (250mg amoxicillin) for children weighing 5 - 9.9kg and one tablet (250mg amoxicillin for children weighing 10-20kg three times a day for five days."
1121405|NCT00513500|O2|Outcome|Current Practice|"Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Refer children with pneumonia to the nearest health facility."
1121406|NCT00513500|O1|Outcome|Enhanced Treatment|"Intervention: Treatment for malaria and pneumonia:~Treat malaria based on rapid diagnostic test with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Treat pneumonia with half tablet (250mg amoxicillin) for children weighing 5 - 9.9kg and one tablet (250mg amoxicillin for children weighing 10-20kg three times a day for five days."
1121407|NCT00513500|O2|Outcome|Current Practice|"Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Refer children with pneumonia to the nearest health facility."
1121408|NCT00513500|O1|Outcome|Enhanced Treatment|"Intervention: Treatment for malaria and pneumonia:~Treat malaria based on rapid diagnostic test with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Treat pneumonia with half tablet (250mg amoxicillin) for children weighing 5 - 9.9kg and one tablet (250mg amoxicillin for children weighing 10-20kg three times a day for five days."
1121409|NCT00513500|E2|Reported Event|Current Practice|"Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Refer children with pneumonia to the nearest health facility."
1121504|NCT00513344|O1|Outcome|Control Chocolate With no Polyphenols|"cocoa-free chocolate~Control (polyphenol-free)"
1121505|NCT00513344|E3|Reported Event|Control|
1121410|NCT00513500|E1|Reported Event|Enhanced Treatment|"Intervention: Treatment for malaria and pneumonia:~Treat malaria based on rapid diagnostic test with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Treat pneumonia with half tablet (250mg amoxicillin) for children weighing 5 - 9.9kg and one tablet (250mg amoxicillin for children weighing 10-20kg three times a day for five days."
1121411|NCT00513474|B3|Baseline|Total|Total of all reporting groups
1121412|NCT00513474|B2|Baseline|Control Group|Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.
1121413|NCT00513474|B1|Baseline|Rasburicase Group|Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator’s discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant’s uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
1121414|NCT00513474|P2|Participant Flow|Control Group|Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.
1121415|NCT00513474|P1|Participant Flow|Rasburicase Group|Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator’s discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant’s uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
1122405|NCT00510653|E1|Reported Event|Imatinib Mesylate|600 mg/day orally for 6 Weeks
1121416|NCT00513474|O2|Outcome|Control Group|Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.
1121417|NCT00513474|O1|Outcome|Rasburicase Group|Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator’s discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant’s uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
1121418|NCT00513474|O2|Outcome|Control Group|Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.
1121419|NCT00513474|O1|Outcome|Rasburicase Group|Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator’s discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant’s uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
1121420|NCT00513474|O2|Outcome|Control Group|Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.
1121421|NCT00513474|O1|Outcome|Rasburicase Group|Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator’s discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant’s uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
1121422|NCT00513474|O2|Outcome|Control Group|Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.
1121423|NCT00513474|O1|Outcome|Rasburicase Group|Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator’s discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant’s uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
1121424|NCT00513474|E2|Reported Event|Control Group|Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.
1121455|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
1121506|NCT00513344|E2|Reported Event|Milk Chocolate|
1121507|NCT00513344|E1|Reported Event|Dark Chocolate|
1121425|NCT00513474|E1|Reported Event|Rasburicase Group|Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator’s discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant’s uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
1121426|NCT00513435|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
1121427|NCT00513435|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib 175 mg PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
1121428|NCT00513435|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
1121429|NCT00513435|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
1121430|NCT00513435|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
1121431|NCT00513409|B3|Baseline|Total|Total of all reporting groups
1121432|NCT00513409|B2|Baseline|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
1121433|NCT00513409|B1|Baseline|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
1121473|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
1122406|NCT00510510|B4|Baseline|Total|Total of all reporting groups
1121434|NCT00513409|P2|Participant Flow|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
1121435|NCT00513409|P1|Participant Flow|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
1121436|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
1121437|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
1121438|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
1121439|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
1121440|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
1121441|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
1121442|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
1121443|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
1121444|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
1121445|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
1121446|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
1121447|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
1121448|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
1121449|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
1121450|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
1121451|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
1121452|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
1121453|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
1121456|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
1121457|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
1121458|NCT00513409|E2|Reported Event|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
1121459|NCT00513409|E1|Reported Event|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
1121460|NCT00513370|B1|Baseline|Adalimumab 40 mg Eow|adalimumab 40 mg every other week (eow)
1121461|NCT00513370|P1|Participant Flow|Adalimumab 40 mg Eow|adalimumab 40 mg every other week (eow)
1121462|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
1121463|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
1121464|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
1121465|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
1121466|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
1121467|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
1121468|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
1121469|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
1121470|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
1121474|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
1121475|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
1121476|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
1121477|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
1121478|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
1121479|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
1121480|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
1121481|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
1121482|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
1121483|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
1121484|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
1121485|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
1121486|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
1121487|NCT00513370|E1|Reported Event|Adalimumab 40 mg Eow|adalimumab 40 mg every other week (eow)
1121488|NCT00513357|B3|Baseline|Total|Total of all reporting groups
1121489|NCT00513357|B2|Baseline|Placebo|20 mg of placebo before going to sleep at night for a period of 4 weeks.
1121490|NCT00513357|B1|Baseline|Melatonin|20 mg of Melatonin before going to sleep at night for a period of 4 weeks.
1121491|NCT00513357|P2|Participant Flow|Placebo|20 mg of placebo before going to sleep at night for a period of 4 weeks.
1121492|NCT00513357|P1|Participant Flow|Melatonin|20 mg of Melatonin before going to sleep at night for a period of 4 weeks.
1121493|NCT00513357|O2|Outcome|Placebo|20 mg of placebo before going to sleep at night for a period of 4 weeks.
1121494|NCT00513357|O1|Outcome|Melatonin|20 mg of Melatonin before going to sleep at night for a period of 4 weeks.
1121495|NCT00513357|E2|Reported Event|Placebo|20 mg of placebo before going to sleep at night for a period of 4 weeks.
1121496|NCT00513357|E1|Reported Event|Melatonin|20 mg of Melatonin before going to sleep at night for a period of 4 weeks.
1121497|NCT00513344|B1|Baseline|Entire Study Population|Includes groups randomized to receive control first, milk chocolate first, and dark chocolate first
1121498|NCT00513344|P1|Participant Flow|Each Subject Tested the Three Products Randomly Following|"Before the 1st intervention, no food with polyphenols was admitted~Each subject was administered the three products randomly(one product per one-day intervention) according to the six possible sequencies:~Either dark chocolate first, then milk chocolate then control~or dark chocolate first, then control, then milk chocolate~or control first, then dark chocolate, then milk chocolate~or Control first, then milk chocolate, then dark chocolate~or Milk chocolate first, then control, then dark chocolate~or milk chocolate first, then dark chocolate, then control r dark chocolate was given once in the morning (1 day) Products were administered in the morning of the testing day. The testing days (interventions) were separated by a three-day wash-out period."
1121499|NCT00513344|O3|Outcome|Dark Chocolate Containing Polyphenols|"dark chocolate~Dark Chocolate : 1 portion"
1121500|NCT00513344|O2|Outcome|Milk Chocolate Containing Polyphenols|"Bespoke milk chocolate~Milk Chocolate : 1 portion"
1121501|NCT00513344|O1|Outcome|Control Chocolate With no Polyphenols|"cocoa-free chocolate~Control (polyphenol-free)"
1121502|NCT00513344|O3|Outcome|Dark Chocolate Containing Polyphenols|"dark chocolate~Dark Chocolate : 1 portion"
1121509|NCT00513305|B2|Baseline|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
1121510|NCT00513305|B1|Baseline|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
1121534|NCT00513292|O2|Outcome|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
1121694|NCT00511836|B2|Baseline|Placebo|Placebo matching VIVITROL 380 mg - single administration via intramuscular injection on Day 1
1121511|NCT00513305|P2|Participant Flow|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
1121512|NCT00513305|P1|Participant Flow|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
1121513|NCT00513305|O2|Outcome|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
1121514|NCT00513305|O1|Outcome|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
1121515|NCT00513305|O2|Outcome|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
1121559|NCT00513071|O1|Outcome|Treatment (Saracatinib)|"Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally~laboratory biomarker analysis: Correlative studies"
1121679|NCT00511862|B2|Baseline|Neuroendocrine Cancer|neuroendocrine cancer patients with liver metastatic disease, refractory to standard of care therapy
1121516|NCT00513305|O1|Outcome|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
1121517|NCT00513305|O2|Outcome|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
1121518|NCT00513305|O1|Outcome|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
1121519|NCT00513305|O2|Outcome|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
1121520|NCT00513305|O1|Outcome|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
1121521|NCT00513305|O2|Outcome|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
1121522|NCT00513305|O1|Outcome|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
1121560|NCT00513071|E1|Reported Event|Treatment (Saracatinib)|"Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally~laboratory biomarker analysis: Correlative studies"
1121561|NCT00513019|B3|Baseline|Total|Total of all reporting groups
1136412|NCT00469079|O2|Outcome|Taboka|A spitless, oral tobacco pouch.
1121523|NCT00513305|O2|Outcome|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
1121524|NCT00513305|O1|Outcome|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
1121525|NCT00513305|E2|Reported Event|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
1121526|NCT00513305|E1|Reported Event|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
1121527|NCT00513292|B3|Baseline|Total|Total of all reporting groups
1121528|NCT00513292|B2|Baseline|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
1121529|NCT00513292|B1|Baseline|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive FEC comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
1121530|NCT00513292|P2|Participant Flow|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
1121531|NCT00513292|P1|Participant Flow|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive FEC comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
1121562|NCT00513019|B2|Baseline|Placebo|Placebo pills (identical to lamictal pills) were taken by mouth once daily.
1121680|NCT00511862|B1|Baseline|Colorectal Cancer|colorectal cancer patients with liver metastatic disease, refractory to standard of care therapy
1121532|NCT00513292|O2|Outcome|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
1121533|NCT00513292|O1|Outcome|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
1121609|NCT00512252|O1|Outcome|Phase II Dose Treatment|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)"
1121610|NCT00512252|O3|Outcome|Phase I Dose Escalation - Dose Level 3|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose = 240 mcg/kg/d"
1121535|NCT00513292|O1|Outcome|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
1121536|NCT00513292|O2|Outcome|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
1121537|NCT00513292|O1|Outcome|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
1121538|NCT00513292|O2|Outcome|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
1121539|NCT00513292|O1|Outcome|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
1121540|NCT00513292|O2|Outcome|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
1121598|NCT00512252|B1|Baseline|Phase I Dose Escalation (Dose Level 1)|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 1 AMD3100 dose = 80 mcg/kg/d"
1121839|NCT00511706|O1|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
1121541|NCT00513292|O1|Outcome|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
1121542|NCT00513292|O2|Outcome|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
1121543|NCT00513292|O1|Outcome|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
1121544|NCT00513292|E2|Reported Event|Arm B|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
1121545|NCT00513292|E1|Reported Event|Arm A|Patients receive FEC comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
1121546|NCT00513240|B3|Baseline|Total|Total of all reporting groups
1121547|NCT00513240|B2|Baseline|Control Group.|"Patients randomized to receive 3 doses of normal saline control.~Normal saline: Normal saline placebo in 3 doses:dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2."
1121548|NCT00513240|B1|Baseline|EPO Group|"Patients randomized to receive the 3 doses of erythropoetin.~Erythropoetin: Erythropoetin 500 units/kg IV x 3 : dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2"
1121549|NCT00513240|P2|Participant Flow|Control Group.|"Patients randomized to receive 3 doses of normal saline control.~Normal saline: Normal saline placebo in 3 doses:dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2."
1121550|NCT00513240|P1|Participant Flow|EPO Group|"Patients randomized to receive the 3 doses of erythropoetin.~Erythropoetin: Erythropoetin 500 units/kg IV x 3 : dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2"
1121551|NCT00513240|O3|Outcome|Placebo|Placebo
1121552|NCT00513240|O2|Outcome|EPO 500 Units/kg QODx3|Revised dose after FDA clinical hold removed of EPO 500 units/kg every other day for 3 doses
1121553|NCT00513240|O1|Outcome|EPO 1000 Units/kg QDx3|Original dose of 1000 units/kg every day for 3 doses
1121554|NCT00513240|E2|Reported Event|Control Group.|"Patients randomized to receive 3 doses of normal saline control.~Normal saline: Normal saline placebo in 3 doses:dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2."
1121555|NCT00513240|E1|Reported Event|EPO Group|"Patients randomized to receive the 3 doses of erythropoetin.~Erythropoetin: Erythropoetin 500 units/kg IV x 3 : dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2"
1121556|NCT00513071|B1|Baseline|Treatment (Saracatinib)|"Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally~laboratory biomarker analysis: Correlative studies"
1121557|NCT00513071|P1|Participant Flow|Treatment (Saracatinib)|"Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally~laboratory biomarker analysis: Correlative studies"
1121558|NCT00513071|O1|Outcome|Treatment (Saracatinib)|"Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally~laboratory biomarker analysis: Correlative studies"
1121635|NCT00512096|O1|Outcome|Cisplatin + Ifosfamide + Paclitaxel|Cisplatin 25 mg/m^2 IV Days 1-3; Ifosfamide 1200 mg/m^2 IV Days 1-3; Paclitaxel 175 mg/m^2 IV Day 1
1121563|NCT00513019|B1|Baseline|Lamictal|The subjects began lamotrigine at 25 mg/d every other day for 1 week. At week 1, the dose was raised to 25 mg/d. At week 2, the dose was raised to 50 mg/d for 2 weeks. Thereafter, all visits were scheduled every 2 weeks at which times the dose could be increased to 100 mg/d, then 200 mg/d, and finally 300 mg/d unless clinical improvement was attained at a lower dose (clinical improvement was assessed by the investigator with respect to skin picking behavior, thoughts, and urges).
1121564|NCT00513019|P2|Participant Flow|Placebo|Placebo pills (identical to lamictal pills) were taken by mouth once daily.
1121565|NCT00513019|P1|Participant Flow|Lamictal|The subjects began lamotrigine at 25 mg/d every other day for 1 week. At week 1, the dose was raised to 25 mg/d. At week 2, the dose was raised to 50 mg/d for 2 weeks. Thereafter, all visits were scheduled every 2 weeks at which times the dose could be increased to 100 mg/d, then 200 mg/d, and finally 300 mg/d unless clinical improvement was attained at a lower dose (clinical improvement was assessed by the investigator with respect to skin picking behavior, thoughts, and urges).
1121566|NCT00513019|O2|Outcome|Placebo|Placebo pills (identical to lamictal pills) were taken by mouth once daily.
1121567|NCT00513019|O1|Outcome|Lamictal|The subjects began lamotrigine at 25 mg/d every other day for 1 week. At week 1, the dose was raised to 25 mg/d. At week 2, the dose was raised to 50 mg/d for 2 weeks. Thereafter, all visits were scheduled every 2 weeks at which times the dose could be increased to 100 mg/d, then 200 mg/d, and finally 300 mg/d unless clinical improvement was attained at a lower dose (clinical improvement was assessed by the investigator with respect to skin picking behavior, thoughts, and urges).
1121568|NCT00513019|E2|Reported Event|Placebo|Placebo pills (identical to lamictal pills) were taken by mouth once daily.
1121611|NCT00512252|O2|Outcome|Phase I Dose Escalation - Dose Level 2|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 2 AMD3100 dose = 160 mcg/kg/d"
1121612|NCT00512252|O1|Outcome|Phase I Dose Escalation - Dose Level 1|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 1 AMD3100 dose = 80 mcg/kg/d"
1121569|NCT00513019|E1|Reported Event|Lamictal|The subjects began lamotrigine at 25 mg/d every other day for 1 week. At week 1, the dose was raised to 25 mg/d. At week 2, the dose was raised to 50 mg/d for 2 weeks. Thereafter, all visits were scheduled every 2 weeks at which times the dose could be increased to 100 mg/d, then 200 mg/d, and finally 300 mg/d unless clinical improvement was attained at a lower dose (clinical improvement was assessed by the investigator with respect to skin picking behavior, thoughts, and urges).
1121570|NCT00512902|B1|Baseline|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
1121571|NCT00512902|P1|Participant Flow|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
1121572|NCT00512902|O1|Outcome|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
1121573|NCT00512902|O1|Outcome|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
1121574|NCT00512902|O1|Outcome|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
1121575|NCT00512902|O1|Outcome|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
1121576|NCT00512902|O1|Outcome|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
1121577|NCT00512902|E1|Reported Event|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
1121578|NCT00512876|B1|Baseline|Topical Avastin 1.0%|Each participant received topical Avastin to be applied to the affected eye either 2 or 4 times daily over a period of 3 weeks
1121579|NCT00512876|P1|Participant Flow|Topical Avastin 1.0%|Each participant received topical Avastin to be applied to the affected eye either 2 or 4 times daily over a period of 3 weeks
1121580|NCT00512876|O1|Outcome|Topical Avastin 1.0%|Each participant received topical Avastin to be applied to the affected eye either 2 or 4 times daily over a period of 3 weeks
1121581|NCT00512876|O1|Outcome|Topical Avastin 1.0%|Each participant received topical Avastin to be applied to the affected eye either 2 or 4 times daily over a period of 3 weeks
1121582|NCT00512876|E1|Reported Event|Topical Avastin 1.0%|Each participant received topical Avastin to be applied to the affected eye
1121583|NCT00512798|B3|Baseline|Total|Total of all reporting groups
1121584|NCT00512798|B2|Baseline|Phase II|
1121585|NCT00512798|B1|Baseline|Phase I|
1121586|NCT00512798|P2|Participant Flow|Phase II|PS-341 and Temozolomide will be administered in the same manner as in Phase I at doses as determined by the Phase I portion of the trial.
1121587|NCT00512798|P1|Participant Flow|Phase I|PS-341 will be administered intravenously at 1.0 mg/m2 of body weight beginning on days 1, 4, 8, and 11 of every 21 days. If toxicity occurs, dose will be lowered to 0.7 mg/m2. Dose can be raised to a maximum of 1.5 mg/m2. Temozolomide will be orally administered daily at 50 mg/m2 of body weight beginning on day 8 for 6 weeks of every 9-week cycle, followed by a 3-week rest. Minimum dose is 50 mg/m2 and maximum dose is 75 mg/m2.
1121588|NCT00512798|O1|Outcome|Phase II|Patients with advanced, incurable melanoma who are chemotherapy-naive or patients who had undergone prior treatment with Dacarbazine or Temozolomide with treatment failure.
1121589|NCT00512798|O1|Outcome|Phase II|Phase II patients who were available for blood draw on the designated days.
1121590|NCT00512798|O1|Outcome|Phase I|Patients with advanced, incurable melanoma who are chemotherapy-naive or patients who had undergone prior therapy with Dacarbazine or Temozolomide with treatment failure.
1121591|NCT00512798|O1|Outcome|Phase I|Patients with advanced, incurable melanoma who are chemotherapy-naive or patients who had undergone prior therapy with Dacarbazine or Temozolomide with treatment failure.
1121592|NCT00512798|O1|Outcome|Phase I|Patients with advanced, incurable melanoma who are chemotherapy-naive or patients who had undergone prior therapy with Dacarbazine or Temozolomide with treatment failure.
1121593|NCT00512798|E2|Reported Event|Phase II|
1121594|NCT00512798|E1|Reported Event|Phase I|
1121595|NCT00512252|B4|Baseline|Total|Total of all reporting groups
1121596|NCT00512252|B3|Baseline|Phase II Dose Treatment (Dose Level 3)|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose).~The 6 participants that were enrolled in Dose Level 3 in the Phase I portion of the study were carried over to the Phase II analysis. 40 additional patients were enrolled in the Phase II portion of the study using the Dose Level 3 dose."
1121597|NCT00512252|B2|Baseline|Phase I Dose Escalation (Dose Level 2)|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 2 AMD3100 dose = 160 mcg/kg/d"
1137279|NCT00467844|O1|Outcome|GTx -024|1 mg
1121599|NCT00512252|P3|Participant Flow|Phase II Dose Treatment (Dose Level 3)|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose).~The 6 participants that were enrolled in Dose Level 3 in the Phase I portion of the study were carried over to the Phase II analysis. 40 additional patients were enrolled in the Phase II portion of the study using the Dose Level 3 dose."
1121600|NCT00512252|P2|Participant Flow|Phase I Dose Escalation (Dose Level 2)|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 2 AMD3100 dose = 160 mcg/kg/d"
1121601|NCT00512252|P1|Participant Flow|Phase I Dose Escalation (Dose Level 1)|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 1 AMD3100 dose = 80 mcg/kg/d"
1121602|NCT00512252|O1|Outcome|Phase II Dose Treatment|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)"
1121603|NCT00512252|O1|Outcome|Phase II Dose Treatment|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)"
1121604|NCT00512252|O4|Outcome|Total|Phase II Dose Patients
1121605|NCT00512252|O3|Outcome|>= Second Relapse/Salvage|
1121606|NCT00512252|O2|Outcome|Primary Refractory|
1121607|NCT00512252|O1|Outcome|First Relapse, First Salvage|
1121608|NCT00512252|O1|Outcome|Phase II Dose Treatment|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)"
1121613|NCT00512252|O3|Outcome|Phase I Dose Escalation - Dose Level 3|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose = 240 mcg/kg/d"
1121614|NCT00512252|O2|Outcome|Phase I Dose Escalation - Dose Level 2|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 2 AMD3100 dose = 160 mcg/kg/d"
1121615|NCT00512252|O1|Outcome|Phase I Dose Escalation - Dose Level 1|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 1 AMD3100 dose = 80 mcg/kg/d"
1121616|NCT00512252|O1|Outcome|Phase II Dose Treatment|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)"
1121617|NCT00512252|O1|Outcome|Phase II Dose Treatment|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)"
1121618|NCT00512252|O1|Outcome|Phase II Dose Treatment|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)"
1121619|NCT00512252|O1|Outcome|Phase I Dose Escalation/Phase II Dose Treatment|
1121620|NCT00512252|O4|Outcome|Total|Phase II Dose Patients
1121621|NCT00512252|O3|Outcome|>= Second Relapse/Salvage|
1121622|NCT00512252|O2|Outcome|Primary Refractory|
1121623|NCT00512252|O1|Outcome|First Relapse, First Salvage|
1121624|NCT00512252|O1|Outcome|Phase I Dose Escalation|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 1 AMD3100 dose = 80 mcg/kg/d~Dose Level 2 AMD3100 dose = 160 mcg/kg/d~Dose Level 3 AMD3100 dose = 240 mcg/kg/d"
1121625|NCT00512252|E3|Reported Event|Phase II Dose Treatment (Dose Level 3)|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose).~The 6 participants that were enrolled in Dose Level 3 in the Phase I portion of the study were carried over to the Phase II analysis. 40 additional patients were enrolled in the Phase II portion of the study using the Dose Level 3 dose."
1121626|NCT00512252|E2|Reported Event|Phase I Dose Escalation (Dose Level 2)|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 2 AMD3100 dose = 160 mcg/kg/d"
1121627|NCT00512252|E1|Reported Event|Phase I Dose Escalation (Dose Level 1)|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 1 AMD3100 dose = 80 mcg/kg/d"
1121628|NCT00512148|B1|Baseline|Enterocystoplasty With the Neo-bladder Augment|Patients were enrolled who required enterocystoplasty (bladder augmentation). Patients in this study were augmented with with the Tengion neo-bladder augment. During this procedure the neo-bladder augment was surgically attached to the patient's existing bladder to enlarge its size.
1121629|NCT00512148|P1|Participant Flow|Enterocystoplasty With the Neo-bladder Augment|Patients were enrolled who required enterocystoplasty (bladder augmentation). Patients in this study were augmented with with the Tengion neo-bladder augment. During this procedure the neo-bladder augment was surgically attached to the patient's existing bladder to enlarge its size.
1121630|NCT00512148|O1|Outcome|Enterocystoplasty With the Neo-bladder Augment|Patients were enrolled who required enterocystoplasty (bladder augmentation). Patients in this study were augmented with with the Tengion neo-bladder augment. During this procedure the neo-bladder augment was surgically attached to the patient's existing bladder to enlarge its size.
1121631|NCT00512148|O1|Outcome|All Implanted|The number of subjects implanted with the neobladder augment
1121632|NCT00512148|E1|Reported Event|Safety Population|Patients who underwent screening procedures and met inclusion/exclusion criteria.
1121633|NCT00512096|B1|Baseline|Cisplatin + Ifosfamide + Paclitaxel|Cisplatin 25 mg/m^2 IV Days 1-3; Ifosfamide 1200 mg/m^2 IV Days 1-3; Paclitaxel 175 mg/m^2 IV Day 1
1121634|NCT00512096|P1|Participant Flow|Cisplatin + Ifosfamide + Paclitaxel|Cisplatin 25 mg/m^2 IV Days 1-3; Ifosfamide 1200 mg/m^2 IV Days 1-3; Paclitaxel 175 mg/m^2 IV Day 1
1121636|NCT00512096|E1|Reported Event|Cisplatin + Ifosfamide + Paclitaxel|Cisplatin 25 mg/m^2 IV Days 1-3; Ifosfamide 1200 mg/m^2 IV Days 1-3; Paclitaxel 175 mg/m^2 IV Day 1
1121637|NCT00511914|B3|Baseline|Total|Total of all reporting groups
1121638|NCT00511914|B2|Baseline|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
1121639|NCT00511914|B1|Baseline|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
1121640|NCT00511914|P2|Participant Flow|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
1121641|NCT00511914|P1|Participant Flow|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
1121642|NCT00511914|O2|Outcome|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
1121643|NCT00511914|O1|Outcome|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
1121644|NCT00511914|O2|Outcome|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
1121645|NCT00511914|O1|Outcome|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
1121646|NCT00511914|O2|Outcome|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
1121647|NCT00511914|O1|Outcome|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
1121648|NCT00511914|O2|Outcome|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
1121649|NCT00511914|O1|Outcome|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
1121650|NCT00511914|O2|Outcome|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
1121651|NCT00511914|O1|Outcome|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
1121692|NCT00511862|E1|Reported Event|TheraSphere|total population receiving at least one TheraSphere treatment
1121652|NCT00511914|E2|Reported Event|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
1121653|NCT00511914|E1|Reported Event|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
1121654|NCT00511901|B3|Baseline|Total|Total of all reporting groups
1121655|NCT00511901|B2|Baseline|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
1121656|NCT00511901|B1|Baseline|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
1121657|NCT00511901|P2|Participant Flow|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
1121658|NCT00511901|P1|Participant Flow|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
1121659|NCT00511901|O2|Outcome|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
1121660|NCT00511901|O1|Outcome|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
1121661|NCT00511901|O2|Outcome|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
1121662|NCT00511901|O1|Outcome|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
1121663|NCT00511901|O2|Outcome|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
1121664|NCT00511901|O1|Outcome|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
1121665|NCT00511901|O2|Outcome|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
1121666|NCT00511901|O1|Outcome|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
1121667|NCT00511901|O2|Outcome|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
1121668|NCT00511901|O1|Outcome|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
1121669|NCT00511901|O2|Outcome|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
1121670|NCT00511901|O1|Outcome|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
1121671|NCT00511901|O2|Outcome|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
1121672|NCT00511901|O1|Outcome|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
1121673|NCT00511901|O2|Outcome|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
1121674|NCT00511901|O1|Outcome|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
1121675|NCT00511901|E2|Reported Event|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
1121676|NCT00511901|E1|Reported Event|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
1121677|NCT00511862|B4|Baseline|Total|Total of all reporting groups
1121678|NCT00511862|B3|Baseline|Non-Colorectal/Non-neuroendocrine|patients with liver metastatic disease not arising from colorectal cancer or neuroendocrine cancer, refractory to standard of care therapy
1122361|NCT00510809|P2|Participant Flow|Statin and Placebo|20mg daily, double-blind
1121681|NCT00511862|P3|Participant Flow|Non-Colorectal/Non-neuroendocrine|Patients with liver metastatic disease not arising from colorectal cancer or neuroendocrine cancer, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
1121682|NCT00511862|P2|Participant Flow|Neuroendocrine Cancer|Neuroendocrine cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
1121683|NCT00511862|P1|Participant Flow|Colorectal Cancer|Colorectal cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
1121684|NCT00511862|O1|Outcome|Neuroendocrine Cancer|neuroendocrine cancer patients with liver metastatic disease, refractory to standard of care therapy
1121685|NCT00511862|O3|Outcome|All Patients|All patients in colorectal cancer, neuroendocrine cancer and non-colorectal/non-neuroendocrine groups
1121686|NCT00511862|O2|Outcome|Non Colorectal/Non-Neuroendocrine|Patients with metastatic liver disease arising from primary cancers other than colorectal or neuroendocrine cancer who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
1121687|NCT00511862|O1|Outcome|Colorectal Cancer|Colorectal cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
1121688|NCT00511862|O4|Outcome|All Patients|All patients in colorectal cancer, neuroendocrine cancer and non-colorectal/non-neuroendocrine groups
1121689|NCT00511862|O3|Outcome|Non-Colorectal/Non-neuroendocrine|Patients with liver metastatic disease not arising from colorectal cancer or neuroendocrine cancer, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
1121690|NCT00511862|O2|Outcome|Neuroendocrine Cancer|Neuroendocrine cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
1121691|NCT00511862|O1|Outcome|Colorectal Cancer|Colorectal cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
1121695|NCT00511836|B1|Baseline|VIVITROL 380 mg|VIVITROL 380 mg (naltrexone for extended-release injectable suspension) - single administration via intramuscular (IM) injection on Day 1
1121696|NCT00511836|P2|Participant Flow|Placebo|Placebo matching VIVITROL 380 mg - single administration via intramuscular injection on Day 1
1121697|NCT00511836|P1|Participant Flow|VIVITROL 380 mg|VIVITROL 380 mg (naltrexone for extended-release injectable suspension) - single administration via intramuscular (IM) injection on Day 1
1121698|NCT00511836|O2|Outcome|Placebo|Placebo matching VIVITROL 380 mg - single administration via intramuscular injection on Day 1
1121699|NCT00511836|O1|Outcome|VIVITROL 380 mg|VIVITROL 380 mg (naltrexone for extended-release injectable suspension) - single administration via intramuscular (IM) injection on Day 1
1121700|NCT00511836|O2|Outcome|Placebo|Placebo matching VIVITROL 380 mg - single administration via intramuscular injection on Day 1
1121701|NCT00511836|O1|Outcome|VIVITROL 380 mg|VIVITROL 380 mg (naltrexone for extended-release injectable suspension) - single administration via intramuscular (IM) injection on Day 1
1121702|NCT00511836|O2|Outcome|Placebo|Placebo matching VIVITROL 380 mg - single administration via intramuscular injection on Day 1
1121703|NCT00511836|O1|Outcome|VIVITROL 380 mg|VIVITROL 380 mg (naltrexone for extended-release injectable suspension) - single administration via intramuscular (IM) injection on Day 1
1121704|NCT00511836|O2|Outcome|Placebo|Placebo matching VIVITROL 380 mg - single administration via intramuscular injection on Day 1
1121705|NCT00511836|O1|Outcome|VIVITROL 380 mg|VIVITROL 380 mg (naltrexone for extended-release injectable suspension) - single administration via intramuscular (IM) injection on Day 1
1121706|NCT00511836|O2|Outcome|Placebo|Placebo matching VIVITROL 380 mg - single administration via intramuscular injection on Day 1
1121707|NCT00511836|O1|Outcome|VIVITROL 380 mg|VIVITROL 380 mg (naltrexone for extended-release injectable suspension) - single administration via intramuscular (IM) injection on Day 1
1121708|NCT00511836|E3|Reported Event|Optional Open-label VIVITROL Period (2 Months)|Following the 28-day, double-blind treatment period, all subjects were offered a chance to receive open-label VIVITROL for an additional 2 months (2 injections, each separated by 1 month). Safety data are described for all subjects in the VIVITROL open-label period, regardless of the treatment received (VIVITROL or placebo) for the first month.
1121709|NCT00511836|E2|Reported Event|Placebo (Double-blind Period)|Placebo for VIVITROL 380 mg. Data are described for the initial 28-day double-blind period.
1121710|NCT00511836|E1|Reported Event|VIVITROL 380 mg (Double-blind Period)|VIVITROL 380 mg (naltrexone for extended-release injectable suspension). Data are described for the initial 28-day double-blind period.
1121711|NCT00511810|B3|Baseline|Total|Total of all reporting groups
1121712|NCT00511810|B2|Baseline|Low Dose Fish Oil|"Capsule omega-3 fatty acids 2.4g/day (4 capsules/day)~Low Dose Fish Oil : Omega-3 Fatty Acids 2.4g/day in capsule form (4 capsules per day)"
1121713|NCT00511810|B1|Baseline|High Dose Fish Oil|"Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)~High Dose Fish Oil : Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)"
1121714|NCT00511810|P2|Participant Flow|Low Dose Fish Oil|"Capsule omega-3 fatty acids 2.4g/day (4 capsules/day)~Low Dose Fish Oil : Omega-3 Fatty Acids 2.4g/day in capsule form (4 capsules per day)"
1121715|NCT00511810|P1|Participant Flow|High Dose Fish Oil|"Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)~High Dose Fish Oil : Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)"
1121716|NCT00511810|O2|Outcome|Baseline CDRS-R: Low Dose Fish Oil|CDRS-R scores were computed for Low Fish Oil groups.
1121717|NCT00511810|O1|Outcome|Baseline CDRS-R: High Dose Fish Oil|CDRS-R scores were computed for High Fish Oil groups.
1122362|NCT00510809|P1|Participant Flow|Statin and Policosanol|20mg daily, double-blind
1121718|NCT00511810|E2|Reported Event|Low Dose Fish Oil|"Capsule omega-3 fatty acids 2.4g/day (4 capsules/day)~Low Dose Fish Oil : Omega-3 Fatty Acids 2.4g/day in capsule form (4 capsules per day)"
1121719|NCT00511810|E1|Reported Event|High Dose Fish Oil|"Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)~High Dose Fish Oil : Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)"
1121720|NCT00511797|B5|Baseline|Total|Total of all reporting groups
1121721|NCT00511797|B4|Baseline|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
1121722|NCT00511797|B3|Baseline|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121723|NCT00511797|B2|Baseline|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121724|NCT00511797|B1|Baseline|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121725|NCT00511797|P4|Participant Flow|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
1121726|NCT00511797|P3|Participant Flow|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121727|NCT00511797|P2|Participant Flow|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121728|NCT00511797|P1|Participant Flow|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121729|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
1121730|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121731|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121732|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121733|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
1121773|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
1133717|NCT00477269|O1|Outcome|STI571|STI571
1121734|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121735|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121736|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121737|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
1121738|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121739|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121740|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121741|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
1121742|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121743|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121744|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121745|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
1121746|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121747|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121748|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121749|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
1121750|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121751|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121752|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121753|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
1121754|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121755|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121756|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121757|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
1121840|NCT00511706|O2|Outcome|Sham and Ranibizumab|Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
1121758|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121759|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121760|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121761|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
1121762|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121763|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121764|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121765|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
1121766|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121767|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121768|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121769|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
1121770|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121771|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121772|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121774|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121775|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121776|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121777|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
1121778|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121779|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121780|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121781|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
1121782|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121783|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121784|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121785|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
1121786|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121787|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121788|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121789|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
1121790|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121791|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121792|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121793|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
1121794|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121795|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121796|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121797|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
1121798|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121799|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121800|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121801|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
1121802|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121803|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121804|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121805|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
1121806|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121807|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121808|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121809|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
1121810|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121811|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121812|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121813|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
1121814|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121815|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121816|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121817|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
1121818|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121819|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121820|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121821|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
1121822|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121823|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121824|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121825|NCT00511797|E4|Reported Event|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
1121826|NCT00511797|E3|Reported Event|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121827|NCT00511797|E2|Reported Event|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121828|NCT00511797|E1|Reported Event|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
1121829|NCT00511706|B3|Baseline|Total|Total of all reporting groups
1121830|NCT00511706|B2|Baseline|Sham and Ranibizumab|Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
1121831|NCT00511706|B1|Baseline|Dexamethasone and Ranibizumab|Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
1121832|NCT00511706|P2|Participant Flow|Sham and Ranibizumab|Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
1121833|NCT00511706|P1|Participant Flow|Dexamethasone and Ranibizumab|Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
1121834|NCT00511706|O2|Outcome|Sham and Ranibizumab|Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
1121835|NCT00511706|O1|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
1121836|NCT00511706|O2|Outcome|Sham and Ranibizumab|Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
1121837|NCT00511706|O1|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
1121838|NCT00511706|O2|Outcome|Sham and Ranibizumab|Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
1122363|NCT00510809|O3|Outcome|Policosanol|20 mg daily, open label
1121841|NCT00511706|O1|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
1121842|NCT00511706|E2|Reported Event|Sham and Ranibizumab|Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
1121843|NCT00511706|E1|Reported Event|Dexamethasone and Ranibizumab|Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
1121844|NCT00511667|B3|Baseline|Total|Total of all reporting groups
1121845|NCT00511667|B2|Baseline|Placebo|All participants receiving any dose of placebo
1121846|NCT00511667|B1|Baseline|MK-0941|All participants receiving any dose of MK-0941
1121847|NCT00511667|P2|Participant Flow|Placebo|All participants receiving any dose of placebo
1121848|NCT00511667|P1|Participant Flow|MK-0941|All participants receiving any dose of MK-0941
1121849|NCT00511667|O2|Outcome|Placebo|All participants receiving any dose of placebo
1121850|NCT00511667|O1|Outcome|MK-0941|All participants receiving any dose of MK-0941
1121851|NCT00511667|O5|Outcome|Panel E: MK-0941 60 mg|MK-0941 60 mg before 2 meals each day for 14 days. Sampling began after dosing on Day 13.
1121852|NCT00511667|O4|Outcome|Panel D: MK-0941 40 mg Day 13|MK-0941 40 mg before each meal for 13 days. Sampling began after dosing on Day 13. These participants are different from those in Panel C.
1121853|NCT00511667|O3|Outcome|Panel C: MK-0941 40 mg Day 7|MK-0941 40 mg before each meal for 7 days. Sampling began after dosing on Day 7. These participants are different from those in Panel D.
1121854|NCT00511667|O2|Outcome|Panel B: MK-0941 20 mg|MK-0941 20 mg before each meal for 5 days. Sampling began after dosing on Day 5.
1121855|NCT00511667|O1|Outcome|Panel A: MK-0941 10 mg|MK-0941 10 mg before each meal for 5 days. Sampling began after dosing on Day 5.
1121856|NCT00511667|O5|Outcome|Panel E: MK-0941 60 mg|MK-0941 60 mg before 2 meals each day for 14 days. Sampling began after dosing on Day 13.
1121857|NCT00511667|O4|Outcome|Panel D: MK-0941 40 mg Day 13|MK-0941 40 mg before each meal for 13 days. Sampling began after dosing on Day 13. These participants are different from those in Panel C.
1121858|NCT00511667|O3|Outcome|Panel C: MK-0941 40 mg Day 7|MK-0941 40 mg before each meal for 7 days. Sampling began after dosing on Day 7. These participants are different from those in Panel D.
1121859|NCT00511667|O2|Outcome|Panel B: MK-0941 20 mg|MK-0941 20 mg before each meal for 5 days. Sampling began after dosing on Day 5.
1121860|NCT00511667|O1|Outcome|Panel A: MK-0941 10 mg Before Each Meal|MK-0941 10 mg before each meal for 5 days. Sampling began after dosing on Day 5.
1121861|NCT00511667|O5|Outcome|Panel E: MK-0941 60 mg|MK-0941 60 mg before 2 meals each day for 14 days. Sampling began after dosing on Day 13.
1121862|NCT00511667|O4|Outcome|Panel D: MK-0941 40 mg Day 13|MK-0941 40 mg before each meal for 13 days. Sampling began after dosing on Day 13. These participants are different from those in Panel C.
1121863|NCT00511667|O3|Outcome|Panel C: MK-0941 40 mg Day 7|MK-0941 40 mg before each meal for 7 days. Sampling began after dosing on Day 7. These participants are different from those in Panel D.
1121864|NCT00511667|O2|Outcome|Panel B: MK-0941 20 mg|MK-0941 20 mg before each meal for 5 days. Sampling began after dosing on Day 5.
1121865|NCT00511667|O1|Outcome|Panel A: MK-0941 10 mg|MK-0941 10 mg before each meal for 5 days. Sampling began after dosing on Day 5.
1121866|NCT00511667|O5|Outcome|Panel E: MK-0941 60 mg|MK-0941 60 mg before 2 meals each day for 14 days. Sampling began after dosing on Day 13.
1121867|NCT00511667|O4|Outcome|Panel D: MK-0941 40 mg Day 13|MK-0941 40 mg before each meal for 13 days. Sampling began after dosing on Day 13. These participants are different from those in Panel C.
1121868|NCT00511667|O3|Outcome|Panel C: MK-0941 40 mg Day 7|MK-0941 40 mg before each meal for 7 days. Sampling began after dosing on Day 7. These participants are different from those in Panel D.
1121869|NCT00511667|O2|Outcome|Panel B: MK-0941 20 mg|MK-0941 20 mg before each meal for 5 days. Sampling began after dosing on Day 5.
1121870|NCT00511667|O1|Outcome|Panel A: MK-0941 10 mg|MK-0941 10 mg before each meal for 5 days. Sampling began after dosing on Day 5.
1121871|NCT00511667|O5|Outcome|Panel E: MK-0941 60 mg|MK-0941 60 mg before 2 meals each day for 14 days. Sampling began after dosing on Day 13.
1121872|NCT00511667|O4|Outcome|Panel D: MK-0941 40 mg Day 13|MK-0941 40 mg before each meal for 13 days. Sampling began after dosing on Day 13. These participants are different from those in Panel C.
1121873|NCT00511667|O3|Outcome|Panel C: MK-0941 40 mg Day 7|MK-0941 40 mg before each meal for 7 days. Sampling began after dosing on Day 7. These participants are different from those in Panel D.
1121874|NCT00511667|O2|Outcome|Panel B: MK-0941 20 mg|MK-0941 20 mg before each meal for 5 days. Sampling began after dosing on Day 5.
1121875|NCT00511667|O1|Outcome|Panel A: MK-0941 10 mg|MK-0941 10 mg before each meal for 5 days. Sampling began after dosing on Day 5.
1121876|NCT00511667|O2|Outcome|Placebo|All participants receiving any dose of placebo
1121877|NCT00511667|O1|Outcome|MK-0941|All participants receiving any dose of MK-0941
1121878|NCT00511667|E2|Reported Event|Placebo|All participants receiving any dose of placebo
1121879|NCT00511667|E1|Reported Event|MK-0941|All participants receiving any dose of MK-0941
1121880|NCT00511472|B3|Baseline|Total|Total of all reporting groups
1121881|NCT00511472|B2|Baseline|Placebo|Participants receiving placebo while on basal insulin.
1121882|NCT00511472|B1|Baseline|MK-0941|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 while on basal insulin.
1121883|NCT00511472|P2|Participant Flow|Placebo|Participants receiving placebo while on basal insulin.
1121884|NCT00511472|P1|Participant Flow|MK-0941|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 while on basal insulin.
1121885|NCT00511472|O2|Outcome|Placebo|Participants receiving placebo while on basal insulin
1121886|NCT00511472|O1|Outcome|MK-0941|Participants receiving individualized doses of MK-0941 while on basal insulin
1121887|NCT00511472|O3|Outcome|Placebo|Participants receiving placebo while on basal insulin.
1121888|NCT00511472|O2|Outcome|MK-0941 (Titration Group 2)|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 according to Titration Scheme #2 while on basal insulin.
1122364|NCT00510809|O2|Outcome|Statin and Placebo|20mg daily, double-blind
1121889|NCT00511472|O1|Outcome|MK-0941 (Titration Group 1)|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 according to Titration Scheme #1 while on basal insulin.
1121890|NCT00511472|O2|Outcome|Placebo|Participants receiving placebo while on basal insulin.
1121891|NCT00511472|O1|Outcome|MK-0941|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 according to Titration Scheme #2 while on basal insulin.
1121892|NCT00511472|O2|Outcome|Placebo|Participants receiving placebo while on basal insulin.
1121893|NCT00511472|O1|Outcome|MK-0941|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 according to Titration Scheme #1 while on basal insulin.
1121894|NCT00511472|O2|Outcome|Placebo|Participants receiving placebo while on basal insulin.
1121895|NCT00511472|O1|Outcome|MK-0941|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 while on basal insulin.
1121896|NCT00511472|E4|Reported Event|Placebo Titration 2|Participants receiving placebo while on basal insulin.
1121897|NCT00511472|E3|Reported Event|Placebo Titration 1|Participants receiving placebo while on basal insulin.
1121898|NCT00511472|E2|Reported Event|MK-0941 Titration 2|Participants receiving multiple daily q.a.c. administrations of MK-0941 according to Titration Scheme 2 while on basal insulin.
1121899|NCT00511472|E1|Reported Event|MK-0941 Titration 1|Participants receiving multiple daily q.a.c. administrations of MK-0941 according to Titration Scheme 1 while on basal insulin.
1121900|NCT00511433|B3|Baseline|Total|Total of all reporting groups
1121901|NCT00511433|B2|Baseline|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121902|NCT00511433|B1|Baseline|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121903|NCT00511433|P2|Participant Flow|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1122171|NCT00511004|B3|Baseline|High Dose Semiannual DEC/ALB|Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
1121904|NCT00511433|P1|Participant Flow|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121905|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121906|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121907|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121908|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121909|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121910|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121911|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121912|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121913|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121914|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121915|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121916|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121917|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1122365|NCT00510809|O1|Outcome|Statin and Policosanol|20mg daily, double-blind
1121918|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121919|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121920|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121921|NCT00511433|O2|Outcome|DRSP-EE|"Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.~n=number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
1121922|NCT00511433|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.~n=number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
1121923|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121924|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121925|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121926|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121927|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121928|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121929|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121930|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121931|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121932|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121933|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121934|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121935|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121936|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121937|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121938|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121939|NCT00511433|E2|Reported Event|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1122366|NCT00510809|O3|Outcome|Policosanol|20 mg daily, open label
1121940|NCT00511433|E1|Reported Event|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
1121941|NCT00511355|B3|Baseline|Total|Total of all reporting groups
1121942|NCT00511355|B2|Baseline|LNG-EE|"All-participants-treated group. Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day cycles"
1121943|NCT00511355|B1|Baseline|NOMAC-E2|All-participants-treated group. Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles
1121944|NCT00511355|P2|Participant Flow|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1121945|NCT00511355|P1|Participant Flow|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1121946|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1121947|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1121948|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1121949|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1121950|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles.~n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
1121951|NCT00511355|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.~n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
1121952|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1121953|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1121954|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1121955|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1121956|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1121957|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1121958|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1121959|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1121960|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1121961|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1121962|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1121963|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1121964|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1121965|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1121966|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1121967|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1121968|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1121969|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1122172|NCT00511004|B2|Baseline|High Dose Annual DEC/ALB|Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
1121970|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1121971|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1121972|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1121973|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1121974|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1121975|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1121976|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1121977|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1121978|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1121979|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1121980|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1121981|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1121982|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1121983|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1122367|NCT00510809|O2|Outcome|Statin and Placebo|20mg daily, double-blind
1121984|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1121985|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1121986|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1121987|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1121988|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1121989|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1121990|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1121991|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1121992|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1121993|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1121994|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1121995|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1121996|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1121997|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1121998|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1121999|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1122000|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1122001|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1122002|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1122003|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1122004|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1122005|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1122368|NCT00510809|O1|Outcome|Statin and Policosanol|20mg daily, double-blind
1122006|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1122007|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1122008|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1122009|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1122010|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1122011|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1122012|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1122013|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1122014|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1122015|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1122016|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1122017|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1122018|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1122019|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1122020|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1122021|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1122022|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1122023|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1122024|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1122025|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1122026|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1122027|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1122369|NCT00510809|E3|Reported Event|Policosanol|20 mg daily, open label
1122028|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1122029|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1122030|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1122031|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1122032|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1122033|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1122034|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1122035|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1122036|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1122037|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1122038|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1122039|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1122040|NCT00511355|E2|Reported Event|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
1122041|NCT00511355|E1|Reported Event|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
1122042|NCT00511342|B3|Baseline|Total|Total of all reporting groups
1122043|NCT00511342|B2|Baseline|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
1122044|NCT00511342|B1|Baseline|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
1122045|NCT00511342|P2|Participant Flow|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
1122046|NCT00511342|P1|Participant Flow|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
1122047|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
1122048|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
1122049|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
1122073|NCT00511238|P1|Participant Flow|Carfilzomib (A0)|Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of 28 day cycles
1122370|NCT00510809|E2|Reported Event|Statin and Placebo|20mg daily, double-blind
1122050|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
1122051|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
1122052|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
1122053|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
1122054|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
1122055|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
1122056|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
1122126|NCT00511147|O1|Outcome|IGIV3I Grifols 10% (All Subjects)|"Intravenous immunoglobulin~IGIV3I Grifols 10%: IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days."
1122057|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
1122058|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
1122059|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
1122060|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
1122061|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
1122062|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
1122063|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
1122064|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
1122065|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
1122066|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
1122067|NCT00511342|E2|Reported Event|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
1122068|NCT00511342|E1|Reported Event|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
1122069|NCT00511238|B3|Baseline|Total|Total of all reporting groups
1122070|NCT00511238|B2|Baseline|Carfilzomib (A1)|In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
1122071|NCT00511238|B1|Baseline|Carfilzomib (A0)|Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of 28 day cycle
1122072|NCT00511238|P2|Participant Flow|Carfilzomib (A1)|In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
1122074|NCT00511238|O2|Outcome|Carfilzomib (A1) - Response-evaluable Population|"In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.~Response-Evaluable Population(the primary analysis population) was defined as all patients who~had measurable disease at Baseline by either M-protein (serum and/or urine) or by quantitative serum Ig for certain patients with IgA myeloma~received at least 1 dose of carfilzomib~underwent baseline disease response assessments and at least 1 post-baseline disease assessment, or patients who discontinued protocol treatment before Cycle 2 Day 1 due to an AE that was considered to be possibly or probably related to carfilzomib—irrespective of availability of baseline and post-baseline assessment"
1122075|NCT00511238|O1|Outcome|Carfilzomib (A1) - Safety Population|"In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.~Safety population: The safety population was used for the analysis of safety data in this study. The safety population consists of all enrolled patients who received at least 1 dose of carfilzomib. However, for some safety analyses, at least 1 laboratory, neurological, electrocardiogram, or vital sign measurement obtained subsequent to at least 1 dose of carfilzomib was required for inclusion in the analysis of a safety specific parameter. To assess change from baseline, a baseline measurement was also required."
1122076|NCT00511238|O1|Outcome|Carfilzomib (A1)|In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16.If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
1122077|NCT00511238|O1|Outcome|Carfilzomib (A0)|Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle
1123821|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
1122078|NCT00511238|O1|Outcome|Carfilzomib (A1)|"In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.~Assessed by Independent Review Committee"
1122079|NCT00511238|O1|Outcome|Carfilzomib (A0)|"Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle.~Assesed by principal investigator."
1122080|NCT00511238|O2|Outcome|Carfilzomib (A1) for (CBR)|In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles. For subjects with CBR.
1122081|NCT00511238|O1|Outcome|Carfilzomib (A1) for (ORR)|In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles. For subjects with ORR.
1122082|NCT00511238|O1|Outcome|Carfilzomib (A0) for (ORR)|Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle
1122083|NCT00511238|O1|Outcome|Carfilzomib (A1)|"In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.~Assessed by Independent Review Committee"
1122084|NCT00511238|O1|Outcome|Carfilzomib (A0)|"Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of 28 day cycle.~Assessed by principal investigator."
1122085|NCT00511238|O2|Outcome|Carfilzomib (A1)|"In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16.If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.~Response-Evaluable Population:~had measurable disease at Baseline~received at least 1 dose of carfilzomib~underwent baseline disease response assessments and at least 1 post-baseline disease assessment, or discontinued protocol treatment before Cycle 2 Day 1 due to an AE that was considered to be possibly or probably related to carfilzomib"
1122086|NCT00511238|O1|Outcome|Carfilzomib (A0)|"Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle~Response-evaluable Population: Enrolled patients who completed at least 1 cycle of carfilzomib and who underwent disease assessments at Screening, Cycle 1 Day 15, and Cycle 2 Day 24. This analysis set also included patients who discontinued treatment during this time due to an AE that was considered probably related to carfilzomib."
1122087|NCT00511238|E2|Reported Event|Carfilzomib (A1)|In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16.If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
1122088|NCT00511238|E1|Reported Event|Carfilzomib (A0)|Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle
1122089|NCT00511199|B3|Baseline|Total|Total of all reporting groups
1122090|NCT00511199|B2|Baseline|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1122091|NCT00511199|B1|Baseline|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
1122092|NCT00511199|P2|Participant Flow|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1122114|NCT00511199|E2|Reported Event|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1122093|NCT00511199|P1|Participant Flow|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
1122094|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1122095|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
1122096|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1122097|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
1122098|NCT00511199|O2|Outcome|DRSP-EE|"Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).~n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
1123822|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
1122099|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).~n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
1122100|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1122101|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
1122102|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1122103|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
1122104|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1122105|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
1122106|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1122107|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
1122108|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1122109|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
1122110|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1122111|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
1122112|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1122113|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
1122155|NCT00511108|O1|Outcome|Sitagliptin 100 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
1122115|NCT00511199|E1|Reported Event|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
1122116|NCT00511173|B1|Baseline|Pharmacist Dosing|Warfarin dose based on pharmacist dosing
1122117|NCT00511173|P1|Participant Flow|Pharmacist Dosing|Warfarin dose based on pharmacist dosing
1122118|NCT00511173|O2|Outcome|Pharmacist Dosing|Warfarin dose based on clinician dosing
1122119|NCT00511173|O1|Outcome|Algorithm Dosing|Warfarin dose based on algorithm by Sconce, et al.
1122120|NCT00511173|E1|Reported Event|Pharmacist Dosing|Warfarin dose based on pharmacist dosing
1122121|NCT00511147|B1|Baseline|IGIV3I Grifols 10% (All Subjects)|"Intravenous immunoglobulin~IGIV3I Grifols 10%: IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days."
1122122|NCT00511147|P1|Participant Flow|IGIV3I Grifols 10% (All Subjects)|"Intravenous immunoglobulin~IGIV3I Grifols 10%: IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days."
1122123|NCT00511147|O1|Outcome|IGIV3I Grifols 10% (All Subjects)|"Intravenous immunoglobulin~IGIV3I Grifols 10%: IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days."
1122124|NCT00511147|O1|Outcome|IGIV3I Grifols 10% (All Subjects)|"Intravenous immunoglobulin~IGIV3I Grifols 10%: IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days."
1122125|NCT00511147|O1|Outcome|IGIV3I Grifols 10% (All Subjects)|"Intravenous immunoglobulin~IGIV3I Grifols 10%: IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days."
1122127|NCT00511147|E1|Reported Event|IGIV3I Grifols 10% (All Subjects)|"Intravenous immunoglobulin~IGIV3I Grifols 10%: IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days."
1122128|NCT00511134|B3|Baseline|Total|Total of all reporting groups
1122129|NCT00511134|B2|Baseline|Zyban + Placebo|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and placebo pill (1 pill per day x 6 weeks)
1122130|NCT00511134|B1|Baseline|Zyban + Lunesta|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and Eszopiclone (Lunesta; 3 mg qd x 6 weeks)
1122131|NCT00511134|P2|Participant Flow|Zyban + Placebo|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and placebo pill (1 pill per day x 6 weeks)
1122132|NCT00511134|P1|Participant Flow|Zyban + Lunesta|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and Eszopiclone (Lunesta; 3 mg qd x 6 weeks)
1122133|NCT00511134|O2|Outcome|Zyban + Placebo|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and placebo pill (1 pill per day x 6 weeks)
1122134|NCT00511134|O1|Outcome|Zyban + Lunesta|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and Eszopiclone (Lunesta; 3 mg qd x 6 weeks)
1122135|NCT00511134|O2|Outcome|Zyban + Placebo|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and placebo pill (1 pill per day x 6 weeks)
1122136|NCT00511134|O1|Outcome|Zyban + Lunesta|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and Eszopiclone (Lunesta; 3 mg qd x 6 weeks)
1122137|NCT00511134|E2|Reported Event|Zyban + Placebo|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and placebo pill (1 pill per day x 6 weeks)
1122138|NCT00511134|E1|Reported Event|Zyban + Lunesta|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and Eszopiclone (Lunesta; 3 mg qd x 6 weeks)
1122139|NCT00511108|B5|Baseline|Total|Total of all reporting groups
1122140|NCT00511108|B4|Baseline|Placebo|Includes patients receiving once-daily administration of matching placebo to sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
1122141|NCT00511108|B3|Baseline|Sitagliptin 100 mg + Pioglitazone 30 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and pioglitazone 30 mg.
1122142|NCT00511108|B2|Baseline|Pioglitazone 30 mg|Includes patients receiving once-daily administration of pioglitazone 30 mg and matching placebo to sitagliptin 100 mg.
1122143|NCT00511108|B1|Baseline|Sitagliptin 100 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
1122144|NCT00511108|P4|Participant Flow|Placebo|Includes patients receiving once-daily administration of matching placebo to sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
1122145|NCT00511108|P3|Participant Flow|Sitagliptin 100 mg + Pioglitazone 30 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and pioglitazone 30 mg.
1122146|NCT00511108|P2|Participant Flow|Pioglitazone 30 mg|Includes patients receiving once-daily administration of pioglitazone 30 mg and matching placebo to sitagliptin 100 mg.
1122147|NCT00511108|P1|Participant Flow|Sitagliptin 100 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
1122148|NCT00511108|O4|Outcome|Placebo|Includes patients receiving once-daily administration of matching placebo to sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
1122149|NCT00511108|O3|Outcome|Sitagliptin 100 mg + Pioglitazone 30 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and pioglitazone 30 mg.
1122150|NCT00511108|O2|Outcome|Pioglitazone 30 mg|Includes patients receiving once-daily administration of pioglitazone 30 mg and matching placebo to sitagliptin 100 mg.
1122151|NCT00511108|O1|Outcome|Sitagliptin 100 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
1122152|NCT00511108|O4|Outcome|Placebo|Includes patients receiving once-daily administration of matching placebo to sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
1122153|NCT00511108|O3|Outcome|Sitagliptin 100 mg + Pioglitazone 30 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and pioglitazone 30 mg.
1122154|NCT00511108|O2|Outcome|Pioglitazone 30 mg|Includes patients receiving once-daily administration of pioglitazone 30 mg and matching placebo to sitagliptin 100 mg.
1122371|NCT00510809|E1|Reported Event|Statin and Policosanol|20mg daily, double-blind
1122156|NCT00511108|O4|Outcome|Placebo|Includes patients receiving once-daily administration of matching placebo to sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
1122157|NCT00511108|O3|Outcome|Sitagliptin 100 mg + Pioglitazone 30 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and pioglitazone 30 mg.
1122158|NCT00511108|O2|Outcome|Pioglitazone 30 mg|Includes patients receiving once-daily administration of pioglitazone 30 mg and matching placebo to sitagliptin 100 mg.
1122159|NCT00511108|O1|Outcome|Sitagliptin 100 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
1122160|NCT00511108|E4|Reported Event|Placebo|Includes patients receiving once-daily administration of matching placebo to sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
1122161|NCT00511108|E3|Reported Event|Sitagliptin 100 mg + Pioglitazone 30 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and pioglitazone 30 mg.
1122162|NCT00511108|E2|Reported Event|Pioglitazone 30 mg|Includes patients receiving once-daily administration of pioglitazone 30 mg and matching placebo to sitagliptin 100 mg.
1122163|NCT00511108|E1|Reported Event|Sitagliptin 100 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
1122164|NCT00511095|B1|Baseline|HEPLISAV|3000ug 1018 ISS + 20ug HBsAg Intramuscular (IM) injection 0.5mL.
1122165|NCT00511095|P1|Participant Flow|HEPLISAV|3000ug 1018 ISS + 20ug HBsAg Intramuscular (IM) injection 0.5mL.
1122166|NCT00511095|O1|Outcome|HEPLISAV|3000ug 1018 ISS + 20ug HBsAg Intramuscular (IM) injection 0.5mL.
1122167|NCT00511095|O1|Outcome|HEPLISAV|3000ug 1018 ISS + 20ug HBsAg Intramuscular (IM) injection 0.5mL.
1122168|NCT00511095|O1|Outcome|HEPLISAV|3000ug 1018 ISS + 20ug HBsAg Intramuscular (IM) injection 0.5mL.
1122169|NCT00511095|E1|Reported Event|HEPLISAV|3000ug 1018 ISS + 20ug HBsAg Intramuscular (IM) injection 0.5mL.
1122170|NCT00511004|B4|Baseline|Total|Total of all reporting groups
1133718|NCT00477269|O2|Outcome|Placebo|Placebo
1122173|NCT00511004|B1|Baseline|Standard Therapy Annual DEC/ALB|Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)
1122174|NCT00511004|P3|Participant Flow|High Dose Semiannual DEC/ALB|Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
1122175|NCT00511004|P2|Participant Flow|High Dose Annual DEC/ALB|Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
1122176|NCT00511004|P1|Participant Flow|Standard Therapy Annual DEC/ALB|Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)
1122177|NCT00511004|O3|Outcome|High Dose Semiannual DEC/ALB|Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
1122178|NCT00511004|O2|Outcome|High Dose Annual DEC/ALB|Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
1122179|NCT00511004|O1|Outcome|Standard Therapy Annual DEC/ALB|Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)
1122180|NCT00511004|O3|Outcome|Diethylcarbamazine/Albendazole-HD2|"High dose of DEC (300mg) and albendazole (800mg) twice yearly (every 6 months)~Albendazole: Comparing 400 mg to 800 mg dose~Diethylcarbamazine: Providing diethylcarbamazine more frequently in combination with albendazole"
1122181|NCT00511004|O2|Outcome|Diethylcarbamazine/Albendazole- HD1|"High dose of DEC (300mg) and albendazole (800mg) yearly~Albendazole: Comparing 400 mg to 800 mg dose~Diethylcarbamazine: Providing diethylcarbamazine more frequently in combination with albendazole"
1122182|NCT00511004|O1|Outcome|Diethylcarbamazine/Albendazole -STD|"Standard therapy of diethylcarbamazine (DEC) (300mg) and albendazole (400mg) yearly~Albendazole: Comparing 400 mg to 800 mg dose~Diethylcarbamazine: Providing diethylcarbamazine more frequently in combination with albendazole"
1122183|NCT00511004|O3|Outcome|High Dose Semiannual DEC/ALB|Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
1122184|NCT00511004|O2|Outcome|High Dose Annual DEC/ALB|Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
1122185|NCT00511004|O1|Outcome|Standard Therapy Annual DEC/ALB|Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)
1122186|NCT00511004|O3|Outcome|High Dose Semiannual DEC/ALB|Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
1122187|NCT00511004|O2|Outcome|High Dose Annual DEC/ALB|Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
1122188|NCT00511004|O1|Outcome|Standard Therapy Annual DEC/ALB|Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)
1122189|NCT00511004|E3|Reported Event|High Dose Semiannual DEC/AC=LB|Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
1122190|NCT00511004|E2|Reported Event|High Dose Annual DEC/ALB|Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
1122191|NCT00511004|E1|Reported Event|Standard Therapy Annual DEC/ALB|Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)
1122192|NCT00510952|B3|Baseline|Total|Total of all reporting groups
1122193|NCT00510952|B2|Baseline|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
1122194|NCT00510952|B1|Baseline|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
1122195|NCT00510952|P2|Participant Flow|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
1122372|NCT00510783|B3|Baseline|Total|Total of all reporting groups
1122196|NCT00510952|P1|Participant Flow|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
1122197|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
1122198|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
1122199|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
1122200|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
1122201|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
1122202|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
1122203|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
1122204|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
1122205|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
1122206|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
1122207|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
1122208|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
1122209|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
1122210|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
1122211|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
1133719|NCT00477269|O1|Outcome|STI571|STI571
1122212|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
1122213|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
1122214|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
1122215|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
1122216|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
1122217|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
1122218|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
1122219|NCT00510952|E2|Reported Event|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
1122220|NCT00510952|E1|Reported Event|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
1122221|NCT00510887|B1|Baseline|VR-FND|"Bortezomib (VELCADER) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.~Each cycle will be repeated every 28 days for 8 cycles maximum.~Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle~Rituximab: Rituximab 375 mg/m2 IV on day 1~Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3~Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2~Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
1122222|NCT00510887|P1|Participant Flow|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.~Each cycle will be repeated every 28 days for 8 cycles maximum.~Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle~Rituximab: Rituximab 375 mg/m2 IV on day 1~Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3~Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2~Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
1122223|NCT00510887|O1|Outcome|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.~Each cycle will be repeated every 28 days for 8 cycles maximum.~Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle~Rituximab: Rituximab 375 mg/m2 IV on day 1~Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3~Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2~Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
1122224|NCT00510887|O1|Outcome|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.~Each cycle will be repeated every 28 days for 8 cycles maximum.~Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle~Rituximab: Rituximab 375 mg/m2 IV on day 1~Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3~Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2~Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
1122242|NCT00510874|P3|Participant Flow|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122373|NCT00510783|B2|Baseline|Levetiracetam|Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).
1122225|NCT00510887|O1|Outcome|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.~Each cycle will be repeated every 28 days for 8 cycles maximum.~Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle~Rituximab: Rituximab 375 mg/m2 IV on day 1~Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3~Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2~Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
1122226|NCT00510887|O1|Outcome|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.~Each cycle will be repeated every 28 days for 8 cycles maximum.~Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle~Rituximab: Rituximab 375 mg/m2 IV on day 1~Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3~Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2~Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
1122227|NCT00510887|O1|Outcome|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.~Each cycle will be repeated every 28 days for 8 cycles maximum.~Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle~Rituximab: Rituximab 375 mg/m2 IV on day 1~Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3~Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2~Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
1122228|NCT00510887|O1|Outcome|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.~Each cycle will be repeated every 28 days for 8 cycles maximum.~Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle~Rituximab: Rituximab 375 mg/m2 IV on day 1~Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3~Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2~Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
1123823|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
1122229|NCT00510887|E1|Reported Event|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.~Each cycle will be repeated every 28 days for 8 cycles maximum.~Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle~Rituximab: Rituximab 375 mg/m2 IV on day 1~Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3~Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2~Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
1122230|NCT00510874|B8|Baseline|Total|Total of all reporting groups
1122231|NCT00510874|B7|Baseline|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122232|NCT00510874|B6|Baseline|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122233|NCT00510874|B5|Baseline|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122234|NCT00510874|B4|Baseline|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122235|NCT00510874|B3|Baseline|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122236|NCT00510874|B2|Baseline|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122237|NCT00510874|B1|Baseline|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122238|NCT00510874|P7|Participant Flow|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122239|NCT00510874|P6|Participant Flow|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122240|NCT00510874|P5|Participant Flow|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122241|NCT00510874|P4|Participant Flow|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122243|NCT00510874|P2|Participant Flow|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122244|NCT00510874|P1|Participant Flow|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122245|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122246|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122247|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122248|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122249|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122250|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122251|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122252|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122253|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122254|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122255|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122256|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122257|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122258|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122259|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122260|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122261|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122262|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122432|NCT00510484|O2|Outcome|Placebo|
1122263|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122264|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122265|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122266|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122267|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122268|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122269|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122270|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122271|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122272|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122273|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122274|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122275|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122276|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122277|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122278|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122279|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122280|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122281|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122282|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122283|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122284|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122285|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122286|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122287|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122288|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122289|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122290|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122291|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122292|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122293|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122294|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122295|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122296|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122297|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122298|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122299|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122300|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122301|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122302|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122303|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122304|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122305|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122306|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122307|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122308|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122309|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122310|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122311|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122312|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122313|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122314|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122315|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122316|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122317|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122318|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122319|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122320|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122321|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122322|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122323|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122324|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122325|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122326|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122327|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122328|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122329|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122330|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122331|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122332|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122333|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122334|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122335|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122336|NCT00510874|E7|Reported Event|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122337|NCT00510874|E6|Reported Event|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122338|NCT00510874|E5|Reported Event|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122339|NCT00510874|E4|Reported Event|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122340|NCT00510874|E3|Reported Event|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122341|NCT00510874|E2|Reported Event|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122342|NCT00510874|E1|Reported Event|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
1122344|NCT00510835|B3|Baseline|Usual Care|"Usual Care - The attending physicians will treat the subjects according to their standard treatment plan and without any influence from the study team. A member of the study team will simply observe and record what happens.~Usual Care (UC): Attending physicians will provide routine care to subjects. Study measurements and treatments will be based on the physicians'/sites' standard practices."
1122345|NCT00510835|B2|Baseline|Protocolized Standard Care (PSC)|"Protocolized Standard Care (PSC)- The study team will monitor the subjects' blood pressure and blood oxygen level with routine equipment. The study team will use this information to give fluid and heart medications in a structured fashion. CVCs will only be used when standard IVs are unable to give the proper amount of fluids and medicines. Blood transfusions will be given according to currently recommended guidelines.~Protocolized Standard Care (PSC): Routine equipment will be used to monitor subjects' blood pressure and oxygen levels. Early structured treatment is based on the subjects' systolic blood pressure and the study doctors' judgment of fluid status and perfusion status."
1122346|NCT00510835|B1|Baseline|Early Goal Directed Therapy (EGDT)|"Early Goal Directed Therapy (EGDT) - The study team will insert a central venous catheter (CVC) for continuous monitoring of the subjects' central venous pressure (CVP) and central venous oxygen saturation (Scv02). The study team will use this information to give fluid, blood, and heart medications in a structured fashion. The CVC is FDA approved and routinely used in hospitals.~Early Goal Directed Therapy (EGDT): Subjects will have a CVC inserted for continuous monitoring of their CVP and Scv02. Early structured treatment will be provided based on subjects' CVP, mean arterial pressure (MAP) and Scv02 measurements."
1122347|NCT00510835|P3|Participant Flow|Usual Care|"Usual Care - The attending physicians will treat the subjects according to their standard treatment plan and without any influence from the study team. A member of the study team will simply observe and record what happens.~Usual Care (UC): Attending physicians will provide routine care to subjects. Study measurements and treatments will be based on the physicians'/sites' standard practices."
1122383|NCT00510744|O1|Outcome|Pancreatic Enzyme Supplementation|"3 month supplementation in those gastric bypass patients shown to have a fat absorption less than 80%~The ability of pancreatic enzyme supplement: 4 caps with meals, 2 with snacks to improve fat absorption"
1122348|NCT00510835|P2|Participant Flow|Protocolized Standard Care (PSC)|"Protocolized Standard Care (PSC)- The study team will monitor the subjects' blood pressure and blood oxygen level with routine equipment. The study team will use this information to give fluid and heart medications in a structured fashion. CVCs will only be used when standard IVs are unable to give the proper amount of fluids and medicines. Blood transfusions will be given according to currently recommended guidelines.~Protocolized Standard Care (PSC): Routine equipment will be used to monitor subjects' blood pressure and oxygen levels. Early structured treatment is based on the subjects' systolic blood pressure and the study doctors' judgment of fluid status and perfusion status."
1122349|NCT00510835|P1|Participant Flow|Early Goal Directed Therapy (EGDT)|"Early Goal Directed Therapy (EGDT) - The study team will insert a central venous catheter (CVC) for continuous monitoring of the subjects' central venous pressure (CVP) and central venous oxygen saturation (Scv02). The study team will use this information to give fluid, blood, and heart medications in a structured fashion. The CVC is FDA approved and routinely used in hospitals.~Early Goal Directed Therapy (EGDT): Subjects will have a CVC inserted for continuous monitoring of their CVP and Scv02. Early structured treatment will be provided based on subjects' CVP, mean arterial pressure (MAP) and Scv02 measurements."
1122350|NCT00510835|O3|Outcome|Usual Care|"Usual Care - The attending physicians will treat the subjects according to their standard treatment plan and without any influence from the study team. A member of the study team will simply observe and record what happens.~Usual Care (UC): Attending physicians will provide routine care to subjects. Study measurements and treatments will be based on the physicians'/sites' standard practices."
1122351|NCT00510835|O2|Outcome|Protocolized Standard Care (PSC)|"Protocolized Standard Care (PSC)- The study team will monitor the subjects' blood pressure and blood oxygen level with routine equipment. The study team will use this information to give fluid and heart medications in a structured fashion. CVCs will only be used when standard IVs are unable to give the proper amount of fluids and medicines. Blood transfusions will be given according to currently recommended guidelines.~Protocolized Standard Care (PSC): Routine equipment will be used to monitor subjects' blood pressure and oxygen levels. Early structured treatment is based on the subjects' systolic blood pressure and the study doctors' judgment of fluid status and perfusion status."
1122352|NCT00510835|O1|Outcome|Early Goal Directed Therapy (EGDT)|"Early Goal Directed Therapy (EGDT) - The study team will insert a central venous catheter (CVC) for continuous monitoring of the subjects' central venous pressure (CVP) and central venous oxygen saturation (Scv02). The study team will use this information to give fluid, blood, and heart medications in a structured fashion. The CVC is FDA approved and routinely used in hospitals.~Early Goal Directed Therapy (EGDT): Subjects will have a CVC inserted for continuous monitoring of their CVP and Scv02. Early structured treatment will be provided based on subjects' CVP, mean arterial pressure (MAP) and Scv02 measurements."
1122353|NCT00510835|E3|Reported Event|Usual Care|"Usual Care - The attending physicians will treat the subjects according to their standard treatment plan and without any influence from the study team. A member of the study team will simply observe and record what happens.~Usual Care (UC): Attending physicians will provide routine care to subjects. Study measurements and treatments will be based on the physicians'/sites' standard practices."
1122354|NCT00510835|E2|Reported Event|Protocolized Standard Care (PSC)|"Protocolized Standard Care (PSC)- The study team will monitor the subjects' blood pressure and blood oxygen level with routine equipment. The study team will use this information to give fluid and heart medications in a structured fashion. CVCs will only be used when standard IVs are unable to give the proper amount of fluids and medicines. Blood transfusions will be given according to currently recommended guidelines.~Protocolized Standard Care (PSC): Routine equipment will be used to monitor subjects' blood pressure and oxygen levels. Early structured treatment is based on the subjects' systolic blood pressure and the study doctors' judgment of fluid status and perfusion status."
1122355|NCT00510835|E1|Reported Event|Early Goal Directed Therapy (EGDT)|"Early Goal Directed Therapy (EGDT) - The study team will insert a central venous catheter (CVC) for continuous monitoring of the subjects' central venous pressure (CVP) and central venous oxygen saturation (Scv02). The study team will use this information to give fluid, blood, and heart medications in a structured fashion. The CVC is FDA approved and routinely used in hospitals.~Early Goal Directed Therapy (EGDT): Subjects will have a CVC inserted for continuous monitoring of their CVP and Scv02. Early structured treatment will be provided based on subjects' CVP, mean arterial pressure (MAP) and Scv02 measurements."
1122356|NCT00510809|B4|Baseline|Total|Total of all reporting groups
1122357|NCT00510809|B3|Baseline|Policosanol|20 mg daily, open label
1122374|NCT00510783|B1|Baseline|Phenytoin/Fosphenytoin|Patients in the control arm will receive either IV Dilantin (1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals) or IV Fosphenytoin (1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals).
1122375|NCT00510783|P2|Participant Flow|Levetiracetam|Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).
1122376|NCT00510783|P1|Participant Flow|Phenytoin/Fosphenytoin|Patients in the control arm will receive either IV Dilantin (1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals) or IV Fosphenytoin (1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals).
1122377|NCT00510783|O2|Outcome|Levetiracetam|Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).
1122378|NCT00510783|O1|Outcome|Phenytoin/Fosphenytoin|Patients in the control arm will receive either IV Dilantin (1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals) or IV Fosphenytoin (1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals).
1122379|NCT00510783|E2|Reported Event|Levetiracetam|Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).
1122380|NCT00510783|E1|Reported Event|Phenytoin/Fosphenytoin|Patients in the control arm will receive either IV Dilantin (1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals) or IV Fosphenytoin (1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals).
1122381|NCT00510744|B1|Baseline|Pancreatic Enzyme Supplementation|"3 month supplementation in those gastric bypass patients shown to have a fat absorption less than 80%~pancreatic enzyme supplement: 4 caps with meals, 2 with snacks"
1122382|NCT00510744|P1|Participant Flow|Pancreatic Enzyme Supplementation|"3 month supplementation in those gastric bypass patients shown to have a fat absorption less than 80%~pancreatic enzyme supplement: 4 caps with meals, 2 with snacks"
1122384|NCT00510744|E1|Reported Event|Pancreatic Enzyme Supplementation|"3 month supplementation in those gastric bypass patients shown to have a fat absorption less than 80%~pancreatic enzyme supplement: 4 caps with meals, 2 with snacks"
1122385|NCT00510692|B3|Baseline|Total|Total of all reporting groups
1122386|NCT00510692|B2|Baseline|Placebo|"Medium chain triglycerides 2 capsules twice daily for six months.~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
1122387|NCT00510692|B1|Baseline|2g/Day EPA|"Eicosapentanoic Acid (EPA): 2 x 500mg EPA capsules twice daily for 6 months~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
1122388|NCT00510692|P2|Participant Flow|Placebo|Medium chain triglycerides 2 g per day for six months.
1122389|NCT00510692|P1|Participant Flow|2g/Day Eicosapentaenoic Acid (EPA)|Eicosapentaenoic Acid (EPA) 2g per day for six months
1122390|NCT00510692|O2|Outcome|Placebo|"Medium chain triglycerides 2 capsules twice daily for six months.~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
1122391|NCT00510692|O1|Outcome|2g/Day Eicosapentanoic Acid (EPA)|"Eicosapentanoic Acid (EPA): 2 x 500mg EPA capsules twice daily for 6 months~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
1122392|NCT00510692|O2|Outcome|Placebo|"Medium chain triglycerides 2 capsules twice daily for six months.~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
1122393|NCT00510692|O1|Outcome|2g/Day Eicosapentanoic Acid (EPA)|"Eicosapentanoic Acid (EPA): 2 x 500mg EPA capsules twice daily for 6 months~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
1122394|NCT00510692|O2|Outcome|Placebo|"Medium chain triglycerides 2 capsules twice daily for six months.~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
1122395|NCT00510692|O1|Outcome|2g/Day Eicosapentanoic Acid (EPA)|"Eicosapentanoic Acid (EPA): 2 x 500mg EPA capsules twice daily for 6 months~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
1122433|NCT00510484|O1|Outcome|Pancrelipase|
1122434|NCT00510484|O2|Outcome|Placebo|
1122435|NCT00510484|O1|Outcome|Pancrelipase|
1122436|NCT00510484|O2|Outcome|Placebo|
1122437|NCT00510484|O1|Outcome|Pancrelipase|
1122438|NCT00510484|O2|Outcome|Placebo|
1122396|NCT00510692|O2|Outcome|Placebo|"Medium chain triglycerides 2 capsules twice daily for six months.~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
1122397|NCT00510692|O1|Outcome|2g/Day Eicosapentanoic Acid (EPA)|"Eicosapentanoic Acid (EPA): 2 x 500mg EPA capsules twice daily for 6 months~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
1122398|NCT00510692|O2|Outcome|Placebo|Medium chain triglycerides 2g per day for six months
1122399|NCT00510692|O1|Outcome|2g/Day Eicosapentaenoic Acid (EPA)|Eicosapentaenoic Acid (EPA) 2g per day for six months
1122400|NCT00510692|E2|Reported Event|Placebo|"Medium chain triglycerides 2 capsules twice daily for six months.~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
1122401|NCT00510692|E1|Reported Event|2g/Day Eicosapentanoic Acid (EPA)|"Eicosapentanoic Acid (EPA): 2 x 500mg EPA capsules twice daily for 6 months~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
1122402|NCT00510653|B1|Baseline|Imatinib Mesylate|600 mg/day orally for 6 Weeks
1122403|NCT00510653|P1|Participant Flow|Imatinib Mesylate|600 mg/day orally for 6 Weeks
1122404|NCT00510653|O1|Outcome|Imatinib Mesylate|600 mg/day orally for 6 Weeks
1122407|NCT00510510|B3|Baseline|Placebo|Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
1122408|NCT00510510|B2|Baseline|NVA237 200 µg|NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
1122409|NCT00510510|B1|Baseline|NVA237 100 µg|NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days..
1122410|NCT00510510|P3|Participant Flow|Placebo|Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
1122411|NCT00510510|P2|Participant Flow|NVA237 200 µg|NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
1122412|NCT00510510|P1|Participant Flow|NVA237 100 µg|NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
1122413|NCT00510510|O3|Outcome|Placebo|Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
1122414|NCT00510510|O2|Outcome|NVA237 200 µg|NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
1122415|NCT00510510|O1|Outcome|NVA237 100 µg|NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days..
1122416|NCT00510510|O3|Outcome|Placebo|Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
1122417|NCT00510510|O2|Outcome|NVA237 200 µg|NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
1122418|NCT00510510|O1|Outcome|NVA237 100 µg|NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days..
1122419|NCT00510510|E3|Reported Event|Placebo|Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
1122420|NCT00510510|E2|Reported Event|NVA237 200 µg|NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
1122421|NCT00510510|E1|Reported Event|NVA237 100 µg|NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days..
1122422|NCT00510497|B1|Baseline|Autologous HIV-1 ApB DC Vaccine|"Subjects who will receive ApB Dendritic cell vaccine~Autologous HIV-1 ApB DC Vaccine: Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption"
1122423|NCT00510497|P1|Participant Flow|Autologous HIV-1 ApB DC Vaccine|"Subjects who will receive ApB Dendritic cell vaccine~Autologous HIV-1 ApB DC Vaccine: Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption"
1122424|NCT00510497|O1|Outcome|Autologous HIV-1 ApB DC Vaccine|"Subjects who will receive ApB Dendritic cell vaccine~Autologous HIV-1 ApB DC Vaccine: Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption"
1122425|NCT00510497|O1|Outcome|Autologous HIV-1 ApB DC Vaccine|"Subjects who will receive ApB Dendritic cell vaccine~Autologous HIV-1 ApB DC Vaccine: Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption"
1122426|NCT00510497|E1|Reported Event|Autologous HIV-1 ApB DC Vaccine|"Subjects who will receive ApB Dendritic cell vaccine (does not include one enrolled participant who received no study treatment)~Autologous HIV-1 ApB DC Vaccine: Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption"
1122427|NCT00510484|B3|Baseline|Total|Total of all reporting groups
1122428|NCT00510484|B2|Baseline|Pancrelipase/Placebo|
1122429|NCT00510484|B1|Baseline|Placebo/Pancrelipase|
1122430|NCT00510484|P2|Participant Flow|Pancrelipase/Placebo|
1122431|NCT00510484|P1|Participant Flow|Placebo/Pancrelipase|
1122450|NCT00510289|B1|Baseline|All Patients|All patients who signed consent
1122451|NCT00510289|P1|Participant Flow|All Patients|All patients who signed consent
1122452|NCT00510289|O1|Outcome|Evaluable Subjects|Patients who received at least one cycle of study drug and underwent bone marrow assessments
1122453|NCT00510289|O1|Outcome|Evaluable Patients|Patients who received at least one cycle of study drug and underwent bone marrow assessments
1122454|NCT00510289|O1|Outcome|Evaluable Subjects|Patients who received at least one cycle of study drug and underwent bone marrow assessments
1122455|NCT00510289|O1|Outcome|Evaluable Subjects|Patients who received at least one cycle of study drug and underwent bone marrow assessments
1122456|NCT00510289|O1|Outcome|Evaluable Subjects|Patients who received at least one cycle of study drug and underwent bone marrow assessments
1122457|NCT00510289|E1|Reported Event|All Patients|SAEs are listed for all patients who took at least one dose of study drug. Due to early study closure and patient withdrawals, Other AEs are listed for 9 patients only.
1122458|NCT00510276|B3|Baseline|Total|Total of all reporting groups
1122459|NCT00510276|B2|Baseline|Placebo|twice a day for 12 weeks
1122460|NCT00510276|B1|Baseline|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122461|NCT00510276|P2|Participant Flow|Placebo|twice a day for 12 weeks
1122462|NCT00510276|P1|Participant Flow|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122463|NCT00510276|O4|Outcome|Placebo, Non-Smokers|
1122464|NCT00510276|O3|Outcome|Placebo, Smokers|
1122465|NCT00510276|O2|Outcome|Atomoxetine 20 - 50 mg BID, Non-Smokers|
1122466|NCT00510276|O1|Outcome|Atomoxetine 20 - 50 mg BID, Smokers|
1122467|NCT00510276|O4|Outcome|Placebo Non-smokers|
1122468|NCT00510276|O3|Outcome|Placebo, Smokers|
1122469|NCT00510276|O2|Outcome|Atomoxetine 20 - 50 mg BID, Non-smokers|
1122470|NCT00510276|O1|Outcome|Atomoxetine 20 - 50 mg BID, Smokers|
1122471|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122472|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122473|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1133720|NCT00477269|O2|Outcome|Placebo|Placebo
1122474|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122475|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122476|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122477|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122478|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122479|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122480|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122481|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122482|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122483|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122484|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122485|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122486|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122487|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122488|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122489|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122490|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122491|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122492|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122493|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122494|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122495|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122496|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122497|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122498|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122499|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122500|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122501|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122502|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122503|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122504|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122505|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122506|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122507|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122508|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122509|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122510|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122511|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122512|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122513|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122514|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122515|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122516|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122517|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122793|NCT00509873|O1|Outcome|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
1122518|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122519|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122520|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122521|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122522|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122523|NCT00510276|O1|Outcome|Atomoxetine 20 - 50 mg BID and Placebo|
1122524|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122525|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122526|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122527|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122528|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122529|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122530|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122531|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122532|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122533|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122534|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122535|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122536|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122537|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122538|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122539|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122540|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122541|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122542|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
1122543|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122544|NCT00510276|E2|Reported Event|Placebo|twice a day for 12 weeks
1122545|NCT00510276|E1|Reported Event|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
1122546|NCT00510224|B1|Baseline|Octreotide Acetate|Octreotide acetate 30mg intramuscular every 28 days
1122547|NCT00510224|P1|Participant Flow|Octreotide Acetate|Octreotide acetate 30mg intramuscular every 28 days
1122548|NCT00510224|O1|Outcome|Octreotide Acetate|Octreotide acetate 30mg intramuscular every 28 days
1122549|NCT00510224|O1|Outcome|Octreotide Acetate|Octreotide acetate 30mg intramuscular every 28 days
1122550|NCT00510224|O1|Outcome|Octreotide Acetate|Octreotide acetate 30mg intramuscular every 28 days
1122551|NCT00510224|O1|Outcome|Octreotide Acetate|Octreotide acetate 30mg intramuscular every 28 days
1122552|NCT00510224|E1|Reported Event|Octreotide Acetate|Octreotide acetate 30mg intramuscular every 28 days
1122553|NCT00510146|B3|Baseline|Total|Total of all reporting groups
1122554|NCT00510146|B2|Baseline|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
1122555|NCT00510146|B1|Baseline|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
1122556|NCT00510146|P2|Participant Flow|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
1122557|NCT00510146|P1|Participant Flow|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
1122558|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
1122559|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
1122560|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
1122561|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
1122794|NCT00509873|O2|Outcome|Placebo Eye Drops|Placebo eye drops
1122562|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
1122563|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
1122564|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
1122565|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
1122650|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
1122651|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
1122566|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
1122567|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
1122568|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
1122569|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
1122570|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
1122571|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
1122572|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
1122573|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
1122574|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
1122675|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
1122575|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
1122576|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
1122577|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
1122578|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
1122579|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
1122580|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
1122581|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
1122582|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
1122583|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
1122584|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
1122585|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
1122586|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
1122587|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
1122588|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
1122589|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
1122590|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
1122591|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
1122592|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
1122593|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
1122594|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
1122676|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
1122795|NCT00509873|O1|Outcome|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
1122595|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
1122596|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
1122597|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
1122598|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
1122599|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
1122600|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
1122652|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
1122653|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
1122601|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
1122602|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
1122603|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
1122604|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
1122605|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
1122606|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
1122607|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
1122608|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
1122609|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
1122610|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
1122611|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
1122612|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
1122613|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
1122614|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
1122615|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
1122616|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
1122617|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
1122618|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
1122677|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
1122619|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
1122620|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
1122621|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
1122622|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
1122623|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
1122624|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
1122625|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
1122626|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
1122627|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
1122628|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
1122629|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
1122630|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
1122631|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
1122632|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
1122633|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
1122634|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
1122635|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
1122636|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
1122637|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
1122638|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
1122639|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
1122640|NCT00510146|E3|Reported Event|Olanzapine (Open Label Treatment Period|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Visit 9. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Visit 10. Those on higher doses will be reduced between Visit 9 and 10 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at visit 10; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at visit 10). Dose increases beyond visit 10 are permitted and at the investigator's discretion.
1122641|NCT00510146|E2|Reported Event|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
1122678|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
1122642|NCT00510146|E1|Reported Event|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg. which is increased to 10 mg. per day no later than 3-7 days after Visit 2. Subsequent dose increases above 10 mg. (up to a maximum of 20 mg per day) are permitted in 5 mg. per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg. requires study discontinuation.
1122643|NCT00510068|B3|Baseline|Total|Total of all reporting groups
1122644|NCT00510068|B2|Baseline|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
1122645|NCT00510068|B1|Baseline|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
1122646|NCT00510068|P2|Participant Flow|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
1122647|NCT00510068|P1|Participant Flow|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
1122648|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
1122649|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
1122654|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
1122655|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
1122656|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
1122657|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
1122658|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
1122659|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
1122660|NCT00510068|O2|Outcome|Everolimus 5 mg/Day|Participants received 5 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
1122661|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
1122662|NCT00510068|O2|Outcome|Everolimus 5 mg/Day|Participants received 5 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
1122663|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
1122664|NCT00510068|O2|Outcome|Everolimus 5 mg/Day|Participants received 5 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
1122665|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
1122666|NCT00510068|O2|Outcome|Everolimus 5 mg/Day|Participants received 5 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
1122667|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
1122668|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
1122669|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
1122670|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
1122671|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
1122672|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
1122673|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
1122674|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
1122788|NCT00509873|O2|Outcome|Placebo Eye Drops|Placebo eye drops
1122789|NCT00509873|O1|Outcome|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
1122679|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
1122680|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
1122681|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
1122682|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
1122683|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
1122684|NCT00510068|E3|Reported Event|Open Label - Everolimus 10mg|Afinitor OL (for data collected in the open-label period of the study): The open-label set included only patients who received at least one dose of open-label everolimus 10 mg and had at least one safety assessment during the open-label period of the study.
1122685|NCT00510068|E2|Reported Event|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
1122686|NCT00510068|E1|Reported Event|Everolimus 10mg/Day|Afinitor DB: Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
1122687|NCT00509925|B1|Baseline|Entire Trial Population|The entire trial population includes groups randomised to receive either insulin detemir or insulin NPH as their first treatment.
1122688|NCT00509925|P2|Participant Flow|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
1122689|NCT00509925|P1|Participant Flow|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
1122690|NCT00509925|O2|Outcome|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
1122691|NCT00509925|O1|Outcome|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
1122692|NCT00509925|O2|Outcome|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
1122693|NCT00509925|O1|Outcome|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
1122694|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
1122695|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
1122696|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
1122697|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
1122698|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
1122699|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
1122700|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
1122701|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
1122702|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
1122703|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
1122704|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
1122705|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
1122790|NCT00509873|O2|Outcome|Placebo Eye Drops|Placebo eye drops
1122706|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
1122707|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
1122708|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
1122709|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
1122710|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
1122711|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
1122712|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
1122713|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
1123824|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
1122714|NCT00509925|O2|Outcome|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
1122715|NCT00509925|O1|Outcome|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
1122716|NCT00509925|O2|Outcome|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
1122717|NCT00509925|O1|Outcome|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
1122718|NCT00509925|O2|Outcome|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
1122719|NCT00509925|O1|Outcome|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
1122720|NCT00509925|O2|Outcome|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
1122721|NCT00509925|O1|Outcome|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
1122722|NCT00509925|O2|Outcome|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
1122723|NCT00509925|O1|Outcome|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
1122724|NCT00509925|O2|Outcome|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
1122725|NCT00509925|O1|Outcome|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
1122726|NCT00509925|E2|Reported Event|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
1122727|NCT00509925|E1|Reported Event|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
1122728|NCT00509899|B9|Baseline|Total|Total of all reporting groups
1122729|NCT00509899|B8|Baseline|200 mg qd|Participants received an initial dose of Ruxolitinib 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
1122730|NCT00509899|B7|Baseline|100 mg qd|Participants received an initial dose of Ruxolitinib 100 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
1122731|NCT00509899|B6|Baseline|50 mg qd|Participants received an initial dose of Ruxolitinib 50 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
1122732|NCT00509899|B5|Baseline|25 mg qd|Participants received an initial dose of Ruxolitinib 25 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely with dose adjustments for safety and efficacy.
1122733|NCT00509899|B4|Baseline|50 mg Bid|Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
1122734|NCT00509899|B3|Baseline|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
1122735|NCT00509899|B2|Baseline|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
1122791|NCT00509873|O1|Outcome|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
1122792|NCT00509873|O2|Outcome|Placebo Eye Drops|Placebo eye drops
1122736|NCT00509899|B1|Baseline|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
1122737|NCT00509899|P8|Participant Flow|200 mg qd|Participants received an initial dose of Ruxolitinib 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
1122738|NCT00509899|P7|Participant Flow|100 mg qd|Participants received an initial dose of Ruxolitinib 100 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
1122739|NCT00509899|P6|Participant Flow|50 mg qd|Participants received an initial dose of Ruxolitinib 50 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
1122740|NCT00509899|P5|Participant Flow|25 mg qd|Participants received an initial dose of Ruxolitinib 25 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely with dose adjustments for safety and efficacy.
1122741|NCT00509899|P4|Participant Flow|50 mg Bid|Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
1122742|NCT00509899|P3|Participant Flow|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
1122743|NCT00509899|P2|Participant Flow|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
1122744|NCT00509899|P1|Participant Flow|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
1133721|NCT00477269|O1|Outcome|STI571|STI571
1122745|NCT00509899|O5|Outcome|All QD|Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups.
1122746|NCT00509899|O4|Outcome|50 mg Bid|Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
1122747|NCT00509899|O3|Outcome|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
1122748|NCT00509899|O2|Outcome|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
1122749|NCT00509899|O1|Outcome|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
1122750|NCT00509899|O1|Outcome|All Participants|All participants received ruxolitinib at varying initial dose and regimen. Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
1122751|NCT00509899|O4|Outcome|All QD|Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups.
1122752|NCT00509899|O3|Outcome|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
1122753|NCT00509899|O2|Outcome|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
1122754|NCT00509899|O1|Outcome|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
1122755|NCT00509899|O4|Outcome|All QD|Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups.
1122756|NCT00509899|O3|Outcome|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
1122757|NCT00509899|O2|Outcome|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
1122758|NCT00509899|O1|Outcome|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
1122759|NCT00509899|O2|Outcome|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
1122760|NCT00509899|O1|Outcome|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
1122761|NCT00509899|O5|Outcome|All QD|Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups.
1122762|NCT00509899|O4|Outcome|50 mg Bid|Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
1122763|NCT00509899|O3|Outcome|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
1122764|NCT00509899|O2|Outcome|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
1122765|NCT00509899|O1|Outcome|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
1122766|NCT00509899|O5|Outcome|All QD|Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups.
1122767|NCT00509899|O4|Outcome|50 mg Bid|Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
1122768|NCT00509899|O3|Outcome|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
1122769|NCT00509899|O2|Outcome|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
1122770|NCT00509899|O1|Outcome|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
1122771|NCT00509899|O5|Outcome|All QD|Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups.
1122772|NCT00509899|O4|Outcome|50 mg Bid|Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
1122773|NCT00509899|O3|Outcome|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
1122774|NCT00509899|O2|Outcome|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
1122775|NCT00509899|O1|Outcome|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
1122776|NCT00509899|E5|Reported Event|All QD|Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups.
1122777|NCT00509899|E4|Reported Event|50 mg Bid|Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
1122778|NCT00509899|E3|Reported Event|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
1122779|NCT00509899|E2|Reported Event|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
1122780|NCT00509899|E1|Reported Event|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
1122781|NCT00509873|B3|Baseline|Total|Total of all reporting groups
1122782|NCT00509873|B2|Baseline|Placebo Eye Drops|Placebo eye drops
1122783|NCT00509873|B1|Baseline|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
1122784|NCT00509873|P2|Participant Flow|Placebo Eye Drops|Placebo eye drops
1122785|NCT00509873|P1|Participant Flow|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
1122786|NCT00509873|O2|Outcome|Placebo Eye Drops|Placebo eye drops
1122787|NCT00509873|O1|Outcome|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
1122797|NCT00509873|E1|Reported Event|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
1122798|NCT00509795|B5|Baseline|Total|Total of all reporting groups
1122799|NCT00509795|B4|Baseline|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.
1122800|NCT00509795|B3|Baseline|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
1122801|NCT00509795|B2|Baseline|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
1122802|NCT00509795|B1|Baseline|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.
1122803|NCT00509795|P4|Participant Flow|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and received sham injections at interim monthly visits.
1122804|NCT00509795|P3|Participant Flow|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
1122805|NCT00509795|P2|Participant Flow|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
1122806|NCT00509795|P1|Participant Flow|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via intravitreal (IVT) injection every 4 weeks for the first year.
1122807|NCT00509795|O5|Outcome|Total|
1122808|NCT00509795|O4|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.
1122809|NCT00509795|O3|Outcome|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
1133722|NCT00477269|O2|Outcome|Placebo|Placebo
1122810|NCT00509795|O2|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
1122811|NCT00509795|O1|Outcome|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.
1122812|NCT00509795|O5|Outcome|Total|
1122813|NCT00509795|O4|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.
1122814|NCT00509795|O3|Outcome|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
1122815|NCT00509795|O2|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
1122816|NCT00509795|O1|Outcome|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.
1122817|NCT00509795|O5|Outcome|Total|
1122818|NCT00509795|O4|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.
1122819|NCT00509795|O3|Outcome|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
1122820|NCT00509795|O2|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
1122821|NCT00509795|O1|Outcome|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.
1122822|NCT00509795|O5|Outcome|Total|
1122823|NCT00509795|O4|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.
1122824|NCT00509795|O3|Outcome|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
1122825|NCT00509795|O2|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
1122826|NCT00509795|O1|Outcome|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.
1122827|NCT00509795|O5|Outcome|Total|
1122828|NCT00509795|O4|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.
1122829|NCT00509795|O3|Outcome|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
1122830|NCT00509795|O2|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
1122831|NCT00509795|O1|Outcome|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.
1122832|NCT00509795|E4|Reported Event|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits. During the second year of treatment, patients were evaluated every 4 weeks and received IVT injections of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1122833|NCT00509795|E3|Reported Event|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year. During the second year of treatment, patients were evaluated every 4 weeks and received IVT injections of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1122834|NCT00509795|E2|Reported Event|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year. During the second year of treatment, patients were evaluated every 4 weeks and received IVT injections of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1122835|NCT00509795|E1|Reported Event|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via intravitreal (IVT) injection every 4 weeks for the first year. During the second year of treatment, patients were evaluated every 4 weeks and received IVT injections of ranibizumab (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 weeks.
1122836|NCT00509769|B1|Baseline|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
1122837|NCT00509769|P1|Participant Flow|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
1122838|NCT00509769|O1|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
1123376|NCT00508001|E1|Reported Event|ZD6474 300|ZD6474 (Vandetanib) 300 mg ( one tablet per day, orally). plus Best Support Care
1122839|NCT00509769|O1|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
1122840|NCT00509769|O1|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
1122841|NCT00509769|O1|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
1122842|NCT00509769|O1|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
1122843|NCT00509769|O1|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
1122844|NCT00509769|E1|Reported Event|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
1122845|NCT00509600|B1|Baseline|Etanercept|0.8 mg/kg subcutaneously weekly for 90 days
1122846|NCT00509600|P1|Participant Flow|Etanercept|0.8 mg/kg subcutaneously weekly for 90 days
1122847|NCT00509600|O1|Outcome|Etanercept|0.8 mg/kg subcutaneously weekly for 90 days
1122848|NCT00509600|E1|Reported Event|Etanercept|0.8 mg/kg subcutaneously weekly for 90 days
1122849|NCT00509587|B1|Baseline|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1122850|NCT00509587|P1|Participant Flow|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1122851|NCT00509587|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1122852|NCT00509587|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1122853|NCT00509587|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1122854|NCT00509587|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1122855|NCT00509587|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1122856|NCT00509587|E1|Reported Event|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1122857|NCT00509496|B3|Baseline|Total|Total of all reporting groups
1137280|NCT00467844|O3|Outcome|Placebo|Placebo
1122858|NCT00509496|B2|Baseline|Anti-gp100:154-162 TCR TIL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered tumor infiltrating lymphocytes (TIL) cell preparation- minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
1122859|NCT00509496|B1|Baseline|Anti-gp100:154-162 TCR PBL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered peripheral blood lymphocyte (PBL) cell preparation - minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes.~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
1122860|NCT00509496|P2|Participant Flow|Anti-gp100:154-162 TCR TIL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered tumor infiltrating lymphocytes (TIL) cell preparation- minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
1122861|NCT00509496|P1|Participant Flow|Anti-gp100:154-162 TCR PBL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered peripheral blood lymphocyte (PBL) cell preparation - minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes.~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
1122862|NCT00509496|O2|Outcome|Anti-gp100:154-162 TCR TIL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered tumor infiltrating lymphocytes (TIL) cell preparation- minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
1122863|NCT00509496|O1|Outcome|Anti-gp100:154-162 TCR PBL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered peripheral blood lymphocyte (PBL) cell preparation - minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes.~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
1122864|NCT00509496|O2|Outcome|Anti-gp100:154-162 TCR TIL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered tumor infiltrating lymphocytes (TIL) cell preparation- minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
1122865|NCT00509496|O1|Outcome|Anti-gp100:154-162 TCR PBL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered peripheral blood lymphocyte (PBL) cell preparation - minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes.~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
1122866|NCT00509496|E2|Reported Event|Anti-gp100:154-162 TCR TIL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered tumor infiltrating lymphocytes (TIL) cell preparation- minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
1122867|NCT00509496|E1|Reported Event|Anti-gp100:154-162 TCR PBL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered peripheral blood lymphocyte (PBL) cell preparation - minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes.~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
1122868|NCT00509366|B6|Baseline|Total|Total of all reporting groups
1122869|NCT00509366|B5|Baseline|Screen Failure|Screen failures constitute patients who were registered into the study but were not assigned to treatment due to unsuccessful genomic analysis or those who were assigned treatment but not treated after reevaluation of their eligibility.
1122870|NCT00509366|B4|Baseline|Docetaxel + Gemcitabine|Cisplatin Resistant patients were registered at the start of the study, assigned to docetaxel/gemcitabine resistant protocol-based treatment consistent with histology, and treated during the course of the study.
1122871|NCT00509366|B3|Baseline|Pemetrexed + Gemcitabine|Cisplatin Resistant patients were registered at the start of the study, assigned to cisplatin/gemcitabine resistant protocol-based treatment consistent with histology, and treated during the course of the study.
1122872|NCT00509366|B2|Baseline|Cisplatin + Pemetrexed|Cisplatin Sensitive patients were registered at the start of the study, assigned to cisplatin/pemetrexed protocol-based treatment consistent with histology, and treated during the course of the study.
1122873|NCT00509366|B1|Baseline|Cisplatin + Gemcitabine|Cisplatin Sensitive patients were registered at the start of the study, assigned to cisplatin/gemcitabine protocol-based treatment consistent with histology, and treated during the course of the study.
1122874|NCT00509366|P5|Participant Flow|Screen Failure|Screen failures constitute patients who were registered into the study but were not assigned to treatment due to unsuccessful genomic analysis. Nine patients did not undergo biopsy. Eight experienced complications from biopsy. The remaining 34 were deemed ineligible after genomic screening. Note that three patients who were assigned protocol-based treatment (2 in the cisplatin sensitive group and 1 in the cisplatin resistant group) did not receive the treatment and were added to the 51 initially identified as screen failures within the summary of baseline characteristics and outcome measures.
1122875|NCT00509366|P4|Participant Flow|Docetaxel + Gemcitabine|Cisplatin Resistant patients were registered at the start of the study and assigned to docetaxel+ gemcitabine protocol-based treatment consistent with histology.
1122876|NCT00509366|P3|Participant Flow|Pemetrexed + Gemcitabine|Cisplatin Resistant patients were registered at the start of the study and assigned to pemetrexed + gemcitabine protocol-based treatment consistent with histology. One patient who was assigned to this arm was later deemed ineligible before initiating protocol treatment and was classified as a screen failure.
1122877|NCT00509366|P2|Participant Flow|Cisplatin + Pemetrexed|Cisplatin Sensitive patients were registered at the start of the study and assigned to cisplatin + pemetrexed protocol-based treatment consistent with histology. One patient who was assigned to this arm was deemed ineligible due to the discover of brain metastasis. This patient did not receive protocol treatment and was classified as a screen failure.
1122878|NCT00509366|P1|Participant Flow|Cisplatin + Gemcitabine|Cisplatin Sensitive patients were registered at the start of the study and assigned to cisplatin + gemcitabine protocol-based treatment consistent with histology. One patient who was assigned to this arm withdrew from the study. This patient did not receive protocol treatment and was classified as a screen failure.
1122879|NCT00509366|O1|Outcome|Treatment|Treatment refers to the combined cisplatin sensitive and resistant arms of the study.
1122964|NCT00509106|O1|Outcome|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).
1122880|NCT00509366|O1|Outcome|Treatment|Treatment refers to the combined cisplatin sensitive (cisplatin/pemetrexed or cisplatin/gemcitabine) and resistant (pemetrexed/gemcitabine or docetaxel/gemcitabine) arms of the study. Due to the irreproducibility of the genomics-based prediction model for assigning patients into the original cisplatin treatment arms, patients from both arms were combined for analysis.
1122881|NCT00509366|O1|Outcome|Treatment|Treatment refers to the combined cisplatin sensitive and resistant arms of the study. Due to the irreproducibility of the genomics-based prediction model for assigning patients into the original cisplatin treatment arms, patients from both arms were combined for analysis.
1122882|NCT00509366|O1|Outcome|Treatment|Treatment refers to the combined cisplatin sensitive and resistant arms of the study. Due to the irreproducibility of the genomics-based prediction model for assigning patients into the original cisplatin treatment arms, patients from both arms were combined for analysis.
1122883|NCT00509366|E5|Reported Event|Screen Failure|Screen failures constitute patients who were registered into the study and underwent protocol-based procedure (e.g. biopsy, genomic screening), but were not enrolled to genomics-directed, protocol-based therapy. From the participant flow, 9 of the 54 screen failures did not have adverse event follow-up, resulting in a final count of 45 screen failures with adverse event follow-up.
1122884|NCT00509366|E4|Reported Event|Cisplatin Resistant (Post-Amendment)|Pre-amendment cisplatin sensitive refers to patients who experienced adverse events and treated with cisplatin-sensitive protocol based therapy per the amendment dated AFTER 1/25/2010.
1122885|NCT00509366|E3|Reported Event|Cisplatin Resistant (Pre-Amendment)|Pre-amendment cisplatin resistant refers to patients who experienced adverse events and treated with cisplatin-resistant protocol based therapy per the amendment dated 1/25/2010.
1122886|NCT00509366|E2|Reported Event|Cisplatin Sensitive (Post-Amendment)|Post-amendment cisplatin sensitive refers to patients who experienced adverse events and treated with cisplatin-sensitive protocol based therapy per the amendment dated AFTER 1/25/2010.
1122887|NCT00509366|E1|Reported Event|Cisplatin Sensitive (Pre-Amendment)|Pre-amendment cisplatin sensitive refers to patients who experienced adverse events and treated with cisplatin-sensitive protocol based therapy per the amendment dated 1/25/2010.
1122888|NCT00509288|B3|Baseline|Total|Total of all reporting groups
1122889|NCT00509288|B2|Baseline|Anti-MART-1 F5 TCR TIL + HD IL-2|Patients treated with tumor infiltrating lymphocytes (TIL).
1122890|NCT00509288|B1|Baseline|Anti-MART-1 F5 TCR PBL + HD IL-2|Patients treated with peripheral blood lymphocytes (PBL).
1122891|NCT00509288|P2|Participant Flow|Anti-MART-1 F5 TCR TIL + HD IL-2|Patients treated with tumor infiltrating lymphocytes (TIL). A minimum of approximately 5 X 10^8 cells will be given up to 3x10^11 anti-MART-1 F5 TCR engineered TIL or PBL. Day -7 to -5: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr. Day -5 to 1: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days Day 0: Cells will be infused intravenously (i.v.). Patients will receive up to 3x10e^11 (with a minimum of 5x10e^8 cells) anti-MART-1 F5 TCR engineered TIL or PBL Aldesleukin (based on total body weight) 720,000 IU/kg intravenous (IV) over 15 minute every eight hours beginning within 24 hours of cell infusion.
1122892|NCT00509288|P1|Participant Flow|Anti-MART-1 F5 TCR PBL + HD IL-2|Patients treated with peripheral blood lymphocytes (PBL). A minimum of approximately 5 X 10^8 cells will be given up to 3x10^11 anti-MART-1 F5 TCR engineered TIL or PBL. Day -7 to -5: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr. Day -5 to 1: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days. Day 0: Cells will be infused intravenously (i.v.). Patients will receive up to 3x10e^11 (with a minimum of 5x10e^8 cells) anti-MART-1 F5 TCR engineered TIL or PBL Aldesleukin (based on total body weight) 720,000 IU/kg intravenous (IV) over 15 minute every eight hours beginning within 24 hours of cell infusion.
1122893|NCT00509288|O2|Outcome|Anti-MART-1 F5 TCR TIL + HD IL-2|Patients treated with tumor infiltrating lymphocytes (TIL).
1122894|NCT00509288|O1|Outcome|Anti-MART-1 F5 TCR PBL + HD IL-2|Patients treated with peripheral blood lymphocytes (PBL).
1122895|NCT00509288|O2|Outcome|Anti-MART-1 F5 TCR TIL + HD IL-2|Patients treated with tumor infiltrating lymphocytes (TIL).
1122896|NCT00509288|O1|Outcome|Anti-MART-1 F5 TCR PBL + HD IL-2|Patients treated with peripheral blood lymphocytes (PBL).
1122897|NCT00509288|E2|Reported Event|Anti-MART-1 F5 TCR TIL + HD IL-2|Patients treated with tumor infiltrating lymphocytes (TIL).
1122898|NCT00509288|E1|Reported Event|Anti-MART-1 F5 TCR PBL + HD IL-2|Patients treated with peripheral blood lymphocytes (PBL).
1122899|NCT00509262|B3|Baseline|Total|Total of all reporting groups
1122900|NCT00509262|B2|Baseline|Glipizide|Participants randomized to glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
1122901|NCT00509262|B1|Baseline|Sitagliptin|Participants randomized to 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
1122902|NCT00509262|P2|Participant Flow|Glipizide|Participants randomized to glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
1122903|NCT00509262|P1|Participant Flow|Sitagliptin|Participants randomized to 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
1122904|NCT00509262|O2|Outcome|Glipizide|Participants received glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
1122905|NCT00509262|O1|Outcome|Sitagliptin|Participants received 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
1122906|NCT00509262|O2|Outcome|Glipizide|Participants received glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
1122907|NCT00509262|O1|Outcome|Sitagliptin|Participants received 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
1122908|NCT00509262|O2|Outcome|Glipizide|Participants received glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
1122909|NCT00509262|O1|Outcome|Sitagliptin|Participants received 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
1122910|NCT00509262|O2|Outcome|Glipizide|Participants received glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
1122911|NCT00509262|O1|Outcome|Sitagliptin|Participants received 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
1122912|NCT00509262|E2|Reported Event|Glipizide|Participants received glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
1122913|NCT00509262|E1|Reported Event|Sitagliptin|Participants received 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
1123825|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
1122914|NCT00509249|B1|Baseline|Arm I|"Patients will receive aflibercept IV at 4 mg/kg over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1122915|NCT00509249|P1|Participant Flow|Arm I|"Patients will receive aflibercept IV at 4 mg/kg over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1122916|NCT00509249|O1|Outcome|Arm I|"Patients will receive aflibercept IV at 4 mg/kg over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1122917|NCT00509249|E1|Reported Event|Arm I|"Patients will receive aflibercept IV at 4 mg/kg over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1122918|NCT00509236|B3|Baseline|Total|Total of all reporting groups
1122919|NCT00509236|B2|Baseline|Glipizide 2.5 mg - 20 mg|Between 2.5 mg - 20 mg daily for 54 weeks
1122920|NCT00509236|B1|Baseline|Sitagliptin 25 mg|One 25 mg tablet once daily for 54 weeks
1122921|NCT00509236|P2|Participant Flow|Glipizide 2.5 mg - 20 mg|Between 2.5 mg - 20 mg daily for 54 weeks
1122922|NCT00509236|P1|Participant Flow|Sitagliptin 25 mg|One 25 mg tablet once daily for 54 weeks
1122923|NCT00509236|O2|Outcome|Glipizide 2.5 mg - 20 mg|Participants received between 2.5 mg - 20 mg daily for 54 weeks
1122924|NCT00509236|O1|Outcome|Sitagliptin 25 mg|Participants received one 25 mg tablet once daily for 54 weeks
1122925|NCT00509236|O2|Outcome|Glipizide 2.5 mg - 20 mg|Participants received between 2.5 mg - 20 mg daily for 54 weeks
1122926|NCT00509236|O1|Outcome|Sitagliptin 25 mg|Participants received one 25 mg tablet once daily for 54 weeks
1122927|NCT00509236|O2|Outcome|Glipizide 2.5 mg - 20 mg|Participants received between 2.5 mg - 20 mg daily for 54 weeks
1122928|NCT00509236|O1|Outcome|Sitagliptin 25 mg|Participants received one 25 mg tablet once daily for 54 weeks
1122929|NCT00509236|O2|Outcome|Glipizide 2.5 mg - 20 mg|Participants received between 2.5 mg - 20 mg daily for 54 weeks
1122930|NCT00509236|O1|Outcome|Sitagliptin 25 mg|Participants received one 25 mg tablet once daily for 54 weeks
1122931|NCT00509236|O1|Outcome|Sitagliptin 25 mg|Participants received one 25 mg tablet once daily for 54 weeks
1122932|NCT00509236|E2|Reported Event|Glipizide 2.5 mg - 20 mg|Between 2.5 mg - 20 mg daily for 54 weeks
1122933|NCT00509236|E1|Reported Event|Sitagliptin 25 mg|One 25 mg tablet once daily for 54 weeks
1122934|NCT00509223|B3|Baseline|Total|Total of all reporting groups
1122935|NCT00509223|B2|Baseline|Lifestyle Counseling|
1122936|NCT00509223|B1|Baseline|Lifestyle Counseling With PAP Therapy|
1122937|NCT00509223|P2|Participant Flow|Group 2|"Lifestyle counseling without Positive Airway Pressure (PAP) therapy~Lifestyle counseling: All subjects were counseled regarding adopting a healthy lifestyle and advised on the Heart Foundation, National Health and Medical Research Council, and American Diabetes Association nutrition and exercise recommendations."
1122938|NCT00509223|P1|Participant Flow|Group 1|"Lifestyle counseling with Positive Airway Pressure (PAP) therapy~Lifestyle counseling: All subjects were counseled regarding adopting a healthy lifestyle and advised on the Heart Foundation, National Health and Medical Research Council, and American Diabetes Association nutrition and exercise recommendations.~Positive Airway Pressure therapy : PAP therapy was initiated at Randomization and continued through the entire study duration (6 months), with instructions for use on a daily basis, during periods of sleep."
1122939|NCT00509223|O2|Outcome|Lifestyle Counseling|
1122940|NCT00509223|O1|Outcome|Lifestyle Counseling With PAP Therapy|
1122941|NCT00509223|E2|Reported Event|Lifestyle Counseling With PAP Therapy|
1122942|NCT00509223|E1|Reported Event|Lifestyle Counseling|
1122943|NCT00509197|B3|Baseline|Total|Total of all reporting groups
1122944|NCT00509197|B2|Baseline|Placebo|Treatment with placebo
1122945|NCT00509197|B1|Baseline|Fluticasone 500 mcg Bid|Treatment with inhaled corticosteroids
1122946|NCT00509197|P2|Participant Flow|Placebo|treatment with placebo
1122947|NCT00509197|P1|Participant Flow|Fluticasone 500 mcg Bid|Treatment with Inhaled Corticosteroids
1122948|NCT00509197|O2|Outcome|Placebo|Use of placebo inhaler (sham fluticasone)
1122949|NCT00509197|O1|Outcome|Fluticasone|Treatment with inhaled corticosteroids
1122950|NCT00509197|O2|Outcome|Placebo|Treatment with placebo
1122951|NCT00509197|O1|Outcome|Fluticasone|Treatment with Fluticasone
1122952|NCT00509197|O2|Outcome|Placebo|Use of placebo inhaler (sham fluticasone)
1122953|NCT00509197|O1|Outcome|Fluticasone|Treatment with inhaled corticosteroids
1122954|NCT00509197|O2|Outcome|Placebo|Use of placebo inhaler (sham fluticasone)
1122955|NCT00509197|O1|Outcome|Fluticasone|Treatment with inhaled corticosteroids
1122956|NCT00509197|E2|Reported Event|Placebo|Treatment with placebo
1122957|NCT00509197|E1|Reported Event|Fluticasone 500 mcg Bid|Treatment with inhaled Corticosteroids
1122958|NCT00509106|B3|Baseline|Total|Total of all reporting groups
1122959|NCT00509106|B2|Baseline|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
1122960|NCT00509106|B1|Baseline|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).
1122961|NCT00509106|P2|Participant Flow|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
1122962|NCT00509106|P1|Participant Flow|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).
1122963|NCT00509106|O2|Outcome|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
1123826|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
1122965|NCT00509106|E2|Reported Event|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
1122966|NCT00509106|E1|Reported Event|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).
1122967|NCT00509067|B3|Baseline|Total|Total of all reporting groups
1122968|NCT00509067|B2|Baseline|Placebos for Galantamine/CDP Choline|Participants assigned to receive placebo
1122969|NCT00509067|B1|Baseline|Galantamine/CDP Choline|Participants assigned to receive galantamine and CDP-choline
1122970|NCT00509067|P2|Participant Flow|Placebos for Galantamine/CDP Choline|Participants assigned to receive placebo
1122971|NCT00509067|P1|Participant Flow|Galantamine/CDP Choline|Participants assigned to receive galantamine and CDP-choline
1122972|NCT00509067|O2|Outcome|Placebos for Galantamine/CDP Choline|Participants assigned to receive placebo
1122973|NCT00509067|O1|Outcome|Galantamine/CDP Choline|Participants assigned to receive galantamine and CDP-choline
1122974|NCT00509067|E2|Reported Event|Placebos for Galantamine/CDP Choline|Participants assigned to receive placebo
1122975|NCT00509067|E1|Reported Event|Galantamine/CDP Choline|Participants assigned to receive galantamine and CDP-choline
1122976|NCT00509041|B1|Baseline|Dasatinib|Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
1122977|NCT00509041|P1|Participant Flow|Dasatinib|Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
1122978|NCT00509041|O1|Outcome|Dasatinib|Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
1122979|NCT00509041|O1|Outcome|Dasatinib|Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
1122980|NCT00509041|O1|Outcome|Dasatinib|Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
1122981|NCT00509041|O1|Outcome|Dasatinib|Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
1122982|NCT00509041|E1|Reported Event|Dasatinib|Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
1122983|NCT00509028|B3|Baseline|Total|Total of all reporting groups
1122984|NCT00509028|B2|Baseline|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
1122985|NCT00509028|B1|Baseline|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
1122986|NCT00509028|P2|Participant Flow|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
1122987|NCT00509028|P1|Participant Flow|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
1122988|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
1122989|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
1122990|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
1122991|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
1122992|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
1122993|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
1122994|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
1122995|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
1122996|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
1122997|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
1123359|NCT00508001|P3|Participant Flow|Placebo|Placebo plus Best Support Care
1122998|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
1122999|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
1123000|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
1123001|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
1123002|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
1123003|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
1123004|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
1123005|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
1123006|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
1123007|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
1123008|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
1123009|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
1123724|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
1123010|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
1123011|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
1123012|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
1123013|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
1123014|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
1123015|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
1123016|NCT00509028|E2|Reported Event|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
1123017|NCT00509028|E1|Reported Event|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
1123018|NCT00508924|B5|Baseline|Total|Total of all reporting groups
1123019|NCT00508924|B4|Baseline|Heparin|"70-100 IU/kg i.v. bolus~additional 2,000-5,000 IU boluses could be given in order to reach the target ACT level of 250 sec"
1123020|NCT00508924|B3|Baseline|ARG350|"350μg/kg i.v. bolus followed by infusion of 25μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
1123021|NCT00508924|B2|Baseline|ARG300|"300μg/kg i.v. bolus followed by infusion of 20μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
1123022|NCT00508924|B1|Baseline|ARG250|"250μg/kg i.v. bolus of argatroban followed by infusion of 15μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
1123023|NCT00508924|P4|Participant Flow|Heparin|"70-100 IU/kg i.v. bolus~additional 2,000-5,000 IU boluses could be given in order to reach the target ACT level of 250 sec"
1123024|NCT00508924|P3|Participant Flow|ARG350|"350μg/kg i.v. bolus followed by infusion of 25μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
1123025|NCT00508924|P2|Participant Flow|ARG300|"300μg/kg i.v. bolus followed by infusion of 20μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
1123026|NCT00508924|P1|Participant Flow|ARG250|"250μg/kg i.v. bolus of argatroban followed by infusion of 15μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
1123027|NCT00508924|O4|Outcome|Heparin|"70-100 IU/kg i.v. bolus~additional 2,000-5,000 IU boluses could be given in order to reach the target ACT level of 250 sec"
1123028|NCT00508924|O3|Outcome|ARG350|"350μg/kg i.v. bolus followed by infusion of 25μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
1123029|NCT00508924|O2|Outcome|ARG300|"300μg/kg i.v. bolus followed by infusion of 20μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
1123030|NCT00508924|O1|Outcome|ARG250|"250μg/kg i.v. bolus of argatroban followed by infusion of 15μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
1123031|NCT00508924|O4|Outcome|Heparin|"70-100 IU/kg i.v. bolus~additional 2,000-5,000 IU boluses could be given in order to reach the target ACT level of 250 sec"
1123032|NCT00508924|O3|Outcome|ARG350|"350μg/kg i.v. bolus followed by infusion of 25μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
1123033|NCT00508924|O2|Outcome|ARG300|"300μg/kg i.v. bolus followed by infusion of 20μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
1123034|NCT00508924|O1|Outcome|ARG250|"250μg/kg i.v. bolus of argatroban followed by infusion of 15μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
1123035|NCT00508924|E4|Reported Event|Heparin|"70-100 IU/kg i.v. bolus~additional 2,000-5,000 IU boluses could be given in order to reach the target ACT level of 250 sec"
1123036|NCT00508924|E3|Reported Event|ARG350|"350μg/kg i.v. bolus followed by infusion of 25μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
1123037|NCT00508924|E2|Reported Event|ARG300|"300μg/kg i.v. bolus followed by infusion of 20μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
1123038|NCT00508924|E1|Reported Event|ARG250|"250μg/kg i.v. bolus of argatroban followed by infusion of 15μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
1123039|NCT00508872|B1|Baseline|FOLFOX-B|FOLFOX-B: 5-Fluorouracil 400 mg/m^2 IV + Bevacizumab 5 mg/kg IV + Leucovorin 400 mg/m^2 IV + Oxaliplatin 85 mg/m^2 IV
1123040|NCT00508872|P1|Participant Flow|FOLFOX-B|FOLFOX-B: 5-Fluorouracil 400 mg/m^2 IV + Bevacizumab 5 mg/kg IV + Leucovorin 400 mg/m^2 IV + Oxaliplatin 85 mg/m^2 IV
1123041|NCT00508872|O1|Outcome|FOLFOX-B|FOLFOX-B: 5-Fluorouracil 400 mg/m^2 IV + Bevacizumab 5 mg/kg IV + Leucovorin 400 mg/m^2 IV + Oxaliplatin 85 mg/m^2 IV
1123042|NCT00508872|E1|Reported Event|FOLFOX-B|FOLFOX-B: 5-Fluorouracil 400 mg/m^2 IV + Bevacizumab 5 mg/kg IV + Leucovorin 400 mg/m^2 IV + Oxaliplatin 85 mg/m^2 IV
1123043|NCT00508820|B3|Baseline|Total|Total of all reporting groups
1123044|NCT00508820|B2|Baseline|Romiplostim (AMG 531) Cohort 2|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under protocol amendments 4 where starting dose was 1mcg/kg.
1123045|NCT00508820|B1|Baseline|Romiplostim (AMG 531) Cohort 1|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under the original protocol or protocol amendments 1-3 where starting dose was 3mcg/kg.
1123046|NCT00508820|P2|Participant Flow|Romiplostim (AMG 531) Cohort 2|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under protocol amendments 4 where starting dose was 1mcg/kg.
1123047|NCT00508820|P1|Participant Flow|Romiplostim (AMG 531) Cohort 1|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under the original protocol or protocol amendments 1-3 where starting dose was 3mcg/kg.
1123048|NCT00508820|O2|Outcome|Romiplostim (AMG 531) Cohort 2|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under protocol amendments 4 where starting dose was 1mcg/kg.
1123049|NCT00508820|O1|Outcome|Romiplostim (AMG 531) Cohort 1|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under the original protocol or protocol amendments 1-3 where starting dose was 3mcg/kg.
1123050|NCT00508820|O2|Outcome|Romiplostim (AMG 531) Cohort 2|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under protocol amendments 4 where starting dose was 1mcg/kg.
1123051|NCT00508820|O1|Outcome|Romiplostim (AMG 531) Cohort 1|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under the original protocol or protocol amendments 1-3 where starting dose was 3mcg/kg.
1123052|NCT00508820|O2|Outcome|Romiplostim (AMG 531) Cohort 2|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under protocol amendments 4 where starting dose was 1mcg/kg.
1123053|NCT00508820|O1|Outcome|Romiplostim (AMG 531) Cohort 1|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under the original protocol or protocol amendments 1-3 where starting dose was 3mcg/kg.
1123054|NCT00508820|E2|Reported Event|Romiplostim Cohort 2|
1123055|NCT00508820|E1|Reported Event|Romiplostim Cohort 1|
1123056|NCT00508755|B1|Baseline|Gait Training After Stroke|Subjects with chronic stroke (.5-1.5 years post stroke) received gait training with the use of functional neuromuscular stimulation with intramuscular electrodes and gait robot.
1123057|NCT00508755|P1|Participant Flow|Gait Training After Stroke|Subjects with chronic stroke (.5-1.5 years post stroke) received gait training with the use of functional neuromuscular stimulation with intramuscular electrodes and gait robot.
1123058|NCT00508755|O3|Outcome|Combined Gait Robot and FES|The 6 study subjects with chronic stroke ambulated with combination Gait Robot and FES, and observational gait analysis was performed.
1123059|NCT00508755|O2|Outcome|FES-Alone|The 6 study subjects with chronic stroke ambulated with FES, and observational gait analysis was performed.
1123060|NCT00508755|O1|Outcome|Gait Robot-alone Training|The 6 study subjects with chronic stroke ambulated in the Gait Robot, and observational gait analysis was performed.
1123061|NCT00508755|E1|Reported Event|Gait Training After Stroke|subjects with Chronic stroke (.5-1.5 years post stroke)received gait training with the use of functional neuromuscular stimulation with intramuscular electrodes and Gait Robot.
1123062|NCT00508742|B3|Baseline|Total|Total of all reporting groups
1123063|NCT00508742|B2|Baseline|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1123064|NCT00508742|B1|Baseline|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1123065|NCT00508742|P2|Participant Flow|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1123066|NCT00508742|P1|Participant Flow|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1123067|NCT00508742|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1123068|NCT00508742|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1123069|NCT00508742|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1123070|NCT00508742|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
1123357|NCT00508001|B2|Baseline|ZD6474 100|ZD6474 (Vandetanib) 100 mg (one tablet per day, orally). plus Best Support Care
1123071|NCT00508742|E8|Reported Event|After Toddler Dose 7vPnC|Participants who received 7vPnC 0.5 mL intramuscularly at 12 months of age in toddler dose, assessed after the toddler dose blood draw through the Month 24 visit.
1123072|NCT00508742|E7|Reported Event|After Toddler Dose 13vPnC|Participants who received 13vPnC 0.5 mL intramuscularly at 12 months of age in toddler dose, assessed after the toddler dose blood draw through the Month 24 visit.
1123073|NCT00508742|E6|Reported Event|Toddler Dose 7vPnC|Participants who received 7vPnC 0.5 mL dose intramuscularly at 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after the toddler dose.
1123074|NCT00508742|E5|Reported Event|Toddler Dose 13vPnC|Participants who received 13vPnC 0.5 mL intramuscularly at 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after the toddler dose.
1123075|NCT00508742|E4|Reported Event|After Infant Series 7vPnC|Participants who received 7vPnC 0.5 mL intramuscularly at 2, 4, and 6 months of age in infant series, assessed after the infant series blood draw to the toddler dose.
1123076|NCT00508742|E3|Reported Event|After Infant Series 13vPnC|Participants who received 13vPnC 0.5 mL intramuscularly at 2, 4, and 6 months of age in infant series, assessed after the infant series blood draw to the toddler dose.
1123077|NCT00508742|E2|Reported Event|Infant Series 7vPnC|Participants who received 7vPnC 0.5 mL intramuscularly at 2, 4 and 6 months of age (infant series), assessed from dose 1 of the infant series through the blood draw 1 month after the infant series.
1123078|NCT00508742|E1|Reported Event|Infant Series 13vPnC|Participants who received 13vPnC 0.5 mL intramuscularly at 2, 4 and 6 months of age (infant series), assessed from dose 1 of the infant series through the blood draw 1 month after the infant series.
1123079|NCT00508716|B3|Baseline|Total|Total of all reporting groups
1123080|NCT00508716|B2|Baseline|Tailored Intervention for Patients With Low Health Literacy an|"Tailored Intervention for patients with low health literacy and nurse-directed teachback~Health Literacy-Tailored Education: Intervention group receives a visit from a nurse educator who, using the teach back method of educating patients, provides counseling on their disease methods of controlling their disease. A video is also viewed to reinforce the materials."
1123081|NCT00508716|B1|Baseline|Usual Care|CHF Education by usual Nurse without teach-back or Video.
1123082|NCT00508716|P2|Participant Flow|Tailored Low Health Literacy Intervention|"Tailored Intervention for patients with low health literacy and nurse-directed teachback: Educational leaflet which has been developed for low-health literacy patients. Adminstered by dedicated Nurse-educator. Nurse-educator asks Patient for teachback after Intervention. This means that the Patient repeats in his/her own words the Information received. Education ends once Patient has been able to repeat the Information back.~Health Literacy-Tailored Education: Intervention group receives a visit from a nurse educator who, using the teach back method of educating patients, provides counseling on their disease methods of controlling their disease. A video is also viewed to reinforce the materials."
1123083|NCT00508716|P1|Participant Flow|Usual Care|Usual Care - Education about CHF by Primary Nurse on discharge. No teach-back is used in this arm.
1123084|NCT00508716|O2|Outcome|Tailored Low Health Literacy Intervention|"Tailored Intervention for patients with low health literacy and nurse-directed teachback: Educational leaflet which has been developed for low-health literacy patients. Adminstered by dedicated Nurse-educator. Nurse-educator asks Patient for teachback after Intervention. This means that the Patient repeats in his/her own words the Information received. Education ends once Patient has been able to repeat the Information back.~Health Literacy-Tailored Education: Intervention group receives a visit from a nurse educator who, using the teach back method of educating patients, provides counseling on their disease methods of controlling their disease. A video is also viewed to reinforce the materials."
1123085|NCT00508716|O1|Outcome|Usual Care|Usual Care - Education about CHF by Primary Nurse on discharge. No teach-back is used in this arm.
1123086|NCT00508716|E2|Reported Event|Teilored Intervention|"Tailored Intervention for patients with low health literacy and nurse-directed teachback: Educational leaflet which has been developed for low-health literacy patients. Adminstered by dedicated Nurse-educator. Nurse-educator asks Patient for teachback after Intervention. This means that the Patient repeats in his/her own words the Information received. Education ends once Patient has been able to repeat the Information back.~Health Literacy-Tailored Education: Intervention group receives a visit from a nurse educator who, using the teach back method of educating patients, provides counseling on their disease methods of controlling their disease. A video is also viewed to reinforce the materials."
1123087|NCT00508716|E1|Reported Event|Usual Care|Usual Care - Education about CHF by Primary Nurse on discharge. No teach-back is used in this arm.
1123088|NCT00508651|B3|Baseline|Total|Total of all reporting groups
1123089|NCT00508651|B2|Baseline|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123090|NCT00508651|B1|Baseline|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123091|NCT00508651|P2|Participant Flow|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123092|NCT00508651|P1|Participant Flow|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123093|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123094|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123095|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123096|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123097|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123098|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123099|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123100|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123101|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123102|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123103|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123104|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123105|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123106|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123107|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123108|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123109|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123110|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123111|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123112|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123113|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123114|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123115|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123116|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123117|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123118|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123119|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123120|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123121|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123122|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123123|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123124|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123125|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123126|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123127|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123128|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123129|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123130|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123131|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123132|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123133|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123134|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123135|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123166|NCT00508521|P1|Participant Flow|FES and Motor Learning Training Group|Subjects < 6 months following first stroke who had diminished upper limb strength, coordination and function.
1123136|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123137|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123138|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123139|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123140|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123141|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123142|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123143|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123144|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123145|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123146|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123147|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123148|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123149|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123150|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123151|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123152|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123153|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123154|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123155|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123156|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123157|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123358|NCT00508001|B1|Baseline|ZD6474 300|ZD6474 (Vandetanib) 300 mg ( one tablet per day, orally). plus Best Support Care
1137281|NCT00467844|O2|Outcome|GTx-024 3 mg|
1123158|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123159|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123160|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123161|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123162|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123163|NCT00508651|E2|Reported Event|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1123164|NCT00508651|E1|Reported Event|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
1123165|NCT00508521|B1|Baseline|Arm 1 Subjects With Acute Stroke|Subjects < 6 months following first stroke who had diminished upper limb strength, coordination and function.
1123167|NCT00508521|O1|Outcome|Arm 1 Subjects With Acute Stroke|Subjects < 6 months following first stroke who had diminished upper limb strength, coordination and function.
1123168|NCT00508521|E1|Reported Event|Arm 1 Subjects With Acute Stroke|Subjects < 6 months following first stroke who had diminished upper limb strength, coordination and function.
1123169|NCT00508482|B4|Baseline|Total|Total of all reporting groups
1123170|NCT00508482|B3|Baseline|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
1123171|NCT00508482|B2|Baseline|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
1123172|NCT00508482|B1|Baseline|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
1123173|NCT00508482|P3|Participant Flow|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
1123174|NCT00508482|P2|Participant Flow|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
1123175|NCT00508482|P1|Participant Flow|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
1123176|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
1123177|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
1123178|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
1123179|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
1123180|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
1123197|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
1123181|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
1123182|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
1123183|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
1123184|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
1133723|NCT00477269|O1|Outcome|STI571|STI571
1123185|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
1123186|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
1123187|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
1123188|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
1123189|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
1123190|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
1123191|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
1123192|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
1123193|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
1123194|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
1123195|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
1123196|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
1123297|NCT00508118|B1|Baseline|Nicardipine|Nicardipine infusion before bypass
1123198|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
1123199|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
1123200|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
1123201|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
1123224|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
1133724|NCT00477269|O2|Outcome|Placebo|Placebo
1123202|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
1123203|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
1123204|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
1123205|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
1123206|NCT00508482|E3|Reported Event|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
1123207|NCT00508482|E2|Reported Event|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
1123208|NCT00508482|E1|Reported Event|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
1123209|NCT00508469|B3|Baseline|Total|Total of all reporting groups
1123210|NCT00508469|B2|Baseline|Travalert With Travoprost and Timolol|One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.
1123211|NCT00508469|B1|Baseline|Travalert With Travoprost/Timolol Fixed Combination|One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
1123212|NCT00508469|P2|Participant Flow|Travalert With Travoprost and Timolol|One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.
1123213|NCT00508469|P1|Participant Flow|Travalert With Travoprost/Timolol Fixed Combination|One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
1123214|NCT00508469|O2|Outcome|Travalert With Travoprost and Timolol|One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.
1123215|NCT00508469|O1|Outcome|Travalert With Travoprost/Timolol Fixed Combination|One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
1123216|NCT00508469|E2|Reported Event|Travalert With Travoprost and Timolol|One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.
1123217|NCT00508469|E1|Reported Event|Travalert With Travoprost/Timolol Fixed Combination|One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
1123218|NCT00508404|B1|Baseline|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
1123298|NCT00508118|P2|Participant Flow|0.9% Saline|0.9% saline (placebo) infusion before bypass
1123219|NCT00508404|P1|Participant Flow|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
1123220|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
1123221|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
1123222|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
1123223|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
1123302|NCT00508118|O2|Outcome|0.9% Saline|0.9% saline (placebo) infusion before bypass
1123225|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
1123226|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
1123227|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
1123228|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
1123229|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
1123230|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
1123231|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
1123232|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
1123233|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
1123234|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
1123235|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
1123236|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
1123237|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
1123238|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
1123239|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
1123240|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
1123241|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
1123314|NCT00508118|O1|Outcome|NICARDIPINE GROUP|Nicardipine prior to bypass
1123242|NCT00508404|E1|Reported Event|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
1123243|NCT00508391|B3|Baseline|Total|Total of all reporting groups
1123244|NCT00508391|B2|Baseline|Optimized 1st, Simultaneous 2nd|Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.
1123245|NCT00508391|B1|Baseline|Simultaneous 1st, Optimized 2nd|Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.
1123246|NCT00508391|P2|Participant Flow|Optimized 1st, Simultaneous 2nd|Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.
1123247|NCT00508391|P1|Participant Flow|Simultaneous 1st, Optimized 2nd|Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.
1123248|NCT00508391|O3|Outcome|Total Subjects|Total subjects enrolled in study.
1123249|NCT00508391|O2|Outcome|Optimized 1st, Simultaneous 2nd|Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.
1123250|NCT00508391|O1|Outcome|Simultaneous 1st, Optimized 2nd|Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.
1123251|NCT00508391|O3|Outcome|Total Subjects|Total subjects enrolled in study.
1123252|NCT00508391|O2|Outcome|Optimized 1st, Simultaneous 2nd|Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.
1123253|NCT00508391|O1|Outcome|Simultaneous 1st, Optimized 2nd|Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.
1123254|NCT00508391|E3|Reported Event|Total Subjects|Total subjects enrolled in study.
1123255|NCT00508391|E2|Reported Event|Optimized 1st, Simultaneous 2nd|Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.
1123256|NCT00508391|E1|Reported Event|Simultaneous 1st, Optimized 2nd|Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.
1123257|NCT00508274|B1|Baseline|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
1123258|NCT00508274|P1|Participant Flow|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
1123259|NCT00508274|O1|Outcome|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
1123260|NCT00508274|O1|Outcome|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
1123261|NCT00508274|O1|Outcome|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
1123262|NCT00508274|O1|Outcome|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
1123263|NCT00508274|O1|Outcome|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
1123264|NCT00508274|O1|Outcome|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
1123265|NCT00508274|E1|Reported Event|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
1123266|NCT00508157|B3|Baseline|Total|Total of all reporting groups
1123267|NCT00508157|B2|Baseline|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
1123268|NCT00508157|B1|Baseline|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
1123269|NCT00508157|P2|Participant Flow|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
1123270|NCT00508157|P1|Participant Flow|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
1123271|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
1123272|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
1123315|NCT00508118|E2|Reported Event|0.9% Saline|0.9% saline (placebo) before bypass
1123316|NCT00508118|E1|Reported Event|Nicardipine|Nicardipine infusion before bypass
1123273|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
1123274|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
1123275|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
1123276|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
1123277|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
1123324|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20 mg of simvastatin once daily
1123278|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
1123279|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
1123280|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
1123281|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
1123282|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
1123283|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
1123284|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
1123285|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
1123286|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
1123287|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
1123288|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
1123289|NCT00508157|E2|Reported Event|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
1123290|NCT00508157|E1|Reported Event|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
1123291|NCT00508144|B1|Baseline|Alimta|Alimta 500 mg/m^2 by vein once over 10 minutes every 3 weeks.
1123292|NCT00508144|P1|Participant Flow|Alimta|Alimta 500 mg/m^2 by vein once over 10 minutes every 3 weeks.
1123293|NCT00508144|O1|Outcome|Alimta|Alimta 500 mg/m^2 by vein once over 10 minutes every 3 weeks.
1123294|NCT00508144|E1|Reported Event|Alimta|Alimta 500 mg/m^2 by vein once over 10 minutes every 3 weeks.
1123295|NCT00508118|B3|Baseline|Total|Total of all reporting groups
1123296|NCT00508118|B2|Baseline|0.9% Saline|0.9% saline (placebo) before bypass
1123299|NCT00508118|P1|Participant Flow|Nicardipine|"Nicardipine infusion before bypass~After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
1123300|NCT00508118|O2|Outcome|0.9% Saline|0.9% saline (placebo) infusion before bypass
1123301|NCT00508118|O1|Outcome|Nicardipine|"Nicardipine infusion before bypass~After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
1133725|NCT00477269|O1|Outcome|STI571|STI571
1123303|NCT00508118|O1|Outcome|Nicardipine|"Nicardipine infusion before bypass~After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
1123304|NCT00508118|O2|Outcome|0.9% Saline|0.9% saline (placebo) infusion before bypass
1123305|NCT00508118|O1|Outcome|Nicardipine|"Nicardipine infusion before bypass~After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
1123306|NCT00508118|O2|Outcome|0.9% Saline|0.9% saline (placebo) infusion before bypass
1123307|NCT00508118|O1|Outcome|Nicardipine|"Nicardipine infusion before bypass~After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
1123308|NCT00508118|O2|Outcome|0.9% Saline|0.9% saline (placebo) infusion before bypass
1123309|NCT00508118|O1|Outcome|Nicardipine|"Nicardipine infusion before bypass~After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
1123310|NCT00508118|O2|Outcome|0.9% Saline|0.9% saline (placebo) infusion before bypass
1123311|NCT00508118|O1|Outcome|Nicardipine|"Nicardipine infusion before bypass~After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
1123312|NCT00508118|O2|Outcome|0.9% Saline|0.9% saline (placebo) infusion before bypass
1123313|NCT00508118|O1|Outcome|Nicardipine|"Nicardipine infusion before bypass~After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
1123317|NCT00508027|B1|Baseline|Simvastatin, Dose Escalation|"There are no arms in this study. Simvastatin will be given in a dose-escalating fashion to 3 sequential dosage groups (20 mg/day, 40 mg/day, 80 mg/day).~Simvastatin : Comparison of 3 dosages of simvastatin given in a dose-escalating fashion.~20 mg, 40 mg, or 80 mg PO QD x 21 days followed by a drug taper x 4 days."
1123318|NCT00508027|P1|Participant Flow|Simvastatin, 3 Escalating Dose Groups|"Simvastatin was given in a dose-escalating fashion to 3 sequential dose groups:~dose level 1= 20 mg/day, dose level 2= 40 mg/day, dose level 3= 80 mg/day The number of subjects starting each dose level are new cohorts of subjects.~Determination of clinical safety in the first dose level group was required in order to begin enrollment in the second dose level group and ultimately the third dose group. Enrollment in the third dose level was discontinued early due to newly reported FDA warnings regarding high dose (80mg/day) simvastatin."
1123319|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
1123320|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
1123321|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20 mg of simvastatin once daily
1123322|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
1123323|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
1123325|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
1123326|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
1123327|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20 mg of simvastatin once daily
1123328|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
1123329|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
1123330|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20 mg of simvastatin once daily
1123331|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|"Subjects received 80 mg daily. Data collected for only 2 participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage"
1123332|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
1123333|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20 mg of simvastatin once daily
1123334|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
1123335|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
1123336|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20mg simvastatin once daily
1123337|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
1123338|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
1123339|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20mg simvastatin once daily
1123340|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
1123341|NCT00508027|O2|Outcome|Dose Level 2|All participants received 40 mg of simvastatin once daily
1123342|NCT00508027|O1|Outcome|Dose Level 1|All participants received 20mg simvastatin once daily
1123343|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
1123344|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
1123345|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20mg simvastatin once daily
1123346|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
1123347|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
1123348|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20mg simvastatin once daily
1123349|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; biomarker data were not collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
1123350|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
1123351|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20mg simvastatin once daily
1123352|NCT00508027|E3|Reported Event|Simvastatin, Dose 3|"Simvastatin given in a dose-escalating fashion to 3 sequential dosage groups (20 mg/day, 40 mg/day, 80 mg/day).~Dose 3 = 80mg/day for 21 days, followed by 4-day drug taper. Enrollment in this group discontinued early due to FDA warning re. high dose simvastatin"
1123353|NCT00508027|E2|Reported Event|Simvastatin, Dose 2|"Simvastatin given in a dose-escalating fashion to 3 sequential dosage groups (20 mg/day, 40 mg/day, 80 mg/day).~Dose 2 = 40mg/day for 21 days, followed by a 4-day taper."
1123354|NCT00508027|E1|Reported Event|Simvastatin, Dose 1|"Simvastatin given in a dose-escalating fashion to 3 sequential dosage groups (20 mg/day, 40 mg/day, 80 mg/day).~Dose 1 = 20mg/day for 21 days, followed by 4-day drug taper."
1123360|NCT00508001|P2|Participant Flow|ZD6474 100|ZD6474 (Vandetanib) 100 mg (one tablet per day, orally). plus Best Support Care
1123361|NCT00508001|P1|Participant Flow|ZD6474 300|ZD6474 (Vandetanib) 300 mg ( one tablet per day, orally). plus Best Support Care
1123362|NCT00508001|O3|Outcome|Placebo|Placebo plus Best Support Care
1123363|NCT00508001|O2|Outcome|ZD6474 100|ZD6474 (Vandetanib) 100 mg (one tablet per day, orally). plus Best Support Care
1123364|NCT00508001|O1|Outcome|ZD6474 300|ZD6474 (Vandetanib) 300 mg ( one tablet per day, orally). plus Best Support Care
1123365|NCT00508001|O3|Outcome|Placebo|Placebo plus Best Support Care
1123366|NCT00508001|O2|Outcome|ZD6474 100|ZD6474 (Vandetanib) 100 mg (one tablet per day, orally). plus Best Support Care
1123367|NCT00508001|O1|Outcome|ZD6474 300|ZD6474 (Vandetanib) 300 mg ( one tablet per day, orally). plus Best Support Care
1123368|NCT00508001|O3|Outcome|Placebo|Placebo plus Best Support Care
1123369|NCT00508001|O2|Outcome|ZD6474 100|ZD6474 (Vandetanib) 100 mg (one tablet per day, orally). plus Best Support Care
1123370|NCT00508001|O1|Outcome|ZD6474 300|ZD6474 (Vandetanib) 300 mg ( one tablet per day, orally). plus Best Support Care
1123371|NCT00508001|O3|Outcome|Placebo|Placebo plus Best Support Care
1123372|NCT00508001|O2|Outcome|ZD6474 100|ZD6474 (Vandetanib) 100 mg (one tablet per day, orally). plus Best Support Care
1123373|NCT00508001|O1|Outcome|ZD6474 300|ZD6474 (Vandetanib) 300 mg ( one tablet per day, orally). plus Best Support Care
1123374|NCT00508001|E3|Reported Event|Placebo|Placebo plus Best Support Care
1123375|NCT00508001|E2|Reported Event|ZD6474 100|ZD6474 (Vandetanib) 100 mg (one tablet per day, orally). plus Best Support Care
1133726|NCT00477269|O2|Outcome|Placebo|Placebo
1123377|NCT00507819|B1|Baseline|Study Population|Subjects who were randomized to receive either Sildenafil 20mg three times a day by mouth or Placebo three times a day by mouth.
1123378|NCT00507819|P2|Participant Flow|Placebo, Then Sildenafil|Placebo six weeks followed by a six week washout period followed by Sildenafil which will be given at a dose of 20 mg three times-a-day for six weeks
1123379|NCT00507819|P1|Participant Flow|Sildenafil, Then Placebo|Sildenafil will be given at a dose of 20 mg three times-a-day for six weeks followed by a six week washout period followed by placebo for an additional six weeks.
1123380|NCT00507819|O2|Outcome|Placebo|Placebo was given by mouth three times a day for six weeks
1123381|NCT00507819|O1|Outcome|Sildenafil|Sildenafil was given by mouth at a dose of 20 mg three times a day for six weeks
1123382|NCT00507819|O2|Outcome|Placebo|Placebo was given by mouth three times a day for six weeks
1123383|NCT00507819|O1|Outcome|Sildenafil|Sildenafil was given by mouth at a dose of 20 mg three times a day for six weeks
1123384|NCT00507819|O2|Outcome|Placebo|Placebo was given by mouth three times a day for six weeks
1123385|NCT00507819|O1|Outcome|Sildenafil|Sildenafil was given by mouth at a dose of 20 mg three times a day for six weeks
1123386|NCT00507819|O2|Outcome|Placebo|Placebo was given by mouth three times a day for six weeks
1123387|NCT00507819|O1|Outcome|Sildenafil|Sildenafil was given by mouth at a dose of 20 mg three times a day for six weeks
1123388|NCT00507819|E2|Reported Event|Placebo|Placebo was given by mouth three times a day for six weeks
1123389|NCT00507819|E1|Reported Event|Sildenafil|Sildenafil was given by mouth at a dose of 20 mg three times a day for six weeks
1123390|NCT00507767|B1|Baseline|Dasatinib|100 mg orally twice daily
1123391|NCT00507767|P1|Participant Flow|Dasatinib|100 mg orally twice daily
1123392|NCT00507767|O1|Outcome|Dasatinib|100 mg orally twice daily
1123393|NCT00507767|E1|Reported Event|Dasatinib|100 mg orally twice daily
1123394|NCT00507689|B4|Baseline|Total|Total of all reporting groups
1123395|NCT00507689|B3|Baseline|Not Randomized|For Baseline Characteristics, this group includes participants who received FTC/TDF+HBIg in the pre-randomization period only. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
1123396|NCT00507689|B2|Baseline|FTC/TDF|For Baseline Characteristics, this group includes participants who received FTC/TDF+HBIg in the pre-randomization period, and were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
1123397|NCT00507689|B1|Baseline|FTC/TDF+HBIg|For Baseline Characteristics, this group includes participants who received FTC/TDF+HBIg in the pre-randomization period, and were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
1123398|NCT00507689|P2|Participant Flow|FTC/TDF|For the Participant Flow, this group includes participants who received FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily.
1123399|NCT00507689|P1|Participant Flow|FTC/TDF+HBIg|For the Participant Flow, this group includes all participants who received any treatment in the pre-randomization period, and participants who received FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
1123400|NCT00507689|O2|Outcome|FTC/TDF|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
1123401|NCT00507689|O1|Outcome|FTC/TDF+HBIg|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
1123402|NCT00507689|O2|Outcome|FTC/TDF|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
1123403|NCT00507689|O1|Outcome|FTC/TDF+HBIg|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
1123404|NCT00507689|O2|Outcome|FTC/TDF|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
1123405|NCT00507689|O1|Outcome|FTC/TDF+HBIg|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
1123406|NCT00507689|O2|Outcome|FTC/TDF|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
1123407|NCT00507689|O1|Outcome|FTC/TDF+HBIg|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
1123449|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
1123408|NCT00507689|O2|Outcome|FTC/TDF|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
1123409|NCT00507689|O1|Outcome|FTC/TDF+HBIg|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
1123410|NCT00507689|O2|Outcome|FTC/TDF|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
1123411|NCT00507689|O1|Outcome|FTC/TDF+HBIg|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
1123412|NCT00507689|E3|Reported Event|FTC/TDF, Randomized Period|For the reporting of Adverse Events, this group includes participants who received FTC/TDF during the randomized period, and were analyzed from randomization (at the Week 24 visit) to Week 96 (randomized period). FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
1123413|NCT00507689|E2|Reported Event|FTC/TDF+HBIg, Randomized Period|For the reporting of Adverse Events, this group includes participants who received FTC/TDF+HBIg during the randomized period, and were analyzed from randomization (at the Week 24 visit) to Week 96 (randomized period). FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
1123414|NCT00507689|E1|Reported Event|FTC/TDF+HBIg, Pre-randomization Period|For the reporting of Adverse Events, this group includes participants who received FTC/TDF+HBIg during the pre-randomization period, and were analyzed from pretreatment baseline to Week 24 (pre-randomization period). FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
1123415|NCT00507559|B1|Baseline|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
1123416|NCT00507559|P1|Participant Flow|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
1123417|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
1123418|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
1123419|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
1123420|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
1123421|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
1123422|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
1123423|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
1123424|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
1123425|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
1123426|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
1123427|NCT00507559|E1|Reported Event|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
1123428|NCT00507546|B3|Baseline|Total|Total of all reporting groups
1123429|NCT00507546|B2|Baseline|Arm 2|"Placebo then ramelteon~Placebo : Nightly 8mg of placebo (same appearance as ramelteon)"
1123430|NCT00507546|B1|Baseline|Arm 1|"Ramelteon then placebo~Ramelteon : 8 mg nightly"
1123431|NCT00507546|P2|Participant Flow|Arm 2|"Placebo then ramelteon~Placebo : Nightly 8mg of placebo (same appearance as ramelteon)"
1123432|NCT00507546|P1|Participant Flow|Arm 1|"Ramelteon then placebo~Ramelteon : 8 mg nightly"
1123433|NCT00507546|O2|Outcome|Arm 2|"Placebo then ramelteon~Placebo : Nightly 8mg of placebo (same appearance as ramelteon)"
1123434|NCT00507546|O1|Outcome|Arm 1|"Ramelteon then placebo~Ramelteon : 8 mg nightly"
1123435|NCT00507546|O2|Outcome|Placebo|"Placebo then ramelteon~Placebo : Nightly 8mg of placebo (same appearance as ramelteon)"
1123436|NCT00507546|O1|Outcome|Ramelteon|"Ramelteon then placebo~Ramelteon : 8 mg nightly"
1123437|NCT00507546|E2|Reported Event|Arm 2|"Placebo then ramelteon~Placebo : Nightly 8mg of placebo (same appearance as ramelteon)"
1123438|NCT00507546|E1|Reported Event|Arm 1|"Ramelteon then placebo~Ramelteon : 8 mg nightly"
1123439|NCT00507507|B3|Baseline|Total|Total of all reporting groups
1123440|NCT00507507|B2|Baseline|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
1123441|NCT00507507|B1|Baseline|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
1123442|NCT00507507|P2|Participant Flow|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
1123443|NCT00507507|P1|Participant Flow|Tenofovir DF|Participants were randomized to receive tenofovir disoproxil fumarate (tenofovir DF; 300 mg tablet) plus placebo to match emtricitabine (FTC; tablet) orally once daily.
1123444|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
1123445|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
1123446|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
1123447|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
1123448|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
1123725|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
1123450|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
1123451|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
1123452|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
1123453|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
1123454|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
1123455|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
1123456|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
1123457|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
1123458|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
1123459|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
1123460|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
1123461|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
1123462|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
1123463|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
1123464|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
1123465|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
1123466|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
1123467|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
1123468|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
1123469|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
1123470|NCT00507507|E4|Reported Event|FTC+Tenofovir DF (24-week Treatment-free Follow-up Period)|"This reporting group includes participants randomized to the FTC+Tenofovir DF group who permanently discontinued study drug on or before the last subject reached Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.~AEs reported for this reporting group are those that occurred during the 24-week treatment-free follow-up period only."
1123471|NCT00507507|E3|Reported Event|Tenofovir DF (24-week Treatment-free Follow-up Period)|"This reporting group includes participants randomized to the Tenofovir DF group who permanently discontinued study drug on or before the last subject reached Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.~AEs reported for this reporting group are those that occurred during the 24-week treatment-free follow-up period only."
1123472|NCT00507507|E2|Reported Event|FTC+Tenofovir DF (Treatment Period)|"Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.~AEs for this reporting group are reported for the entire treatment period."
1123473|NCT00507507|E1|Reported Event|Tenofovir DF (Treatment Period)|"Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.~Adverse events (AEs) for this reporting group are reported for the entire treatment period."
1123474|NCT00507455|B4|Baseline|Total|Total of all reporting groups
1123475|NCT00507455|B3|Baseline|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123803|NCT00506675|E1|Reported Event|Intensive|6 hours daily patching combined with daily atropine
1123476|NCT00507455|B2|Baseline|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123477|NCT00507455|B1|Baseline|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
1123478|NCT00507455|P3|Participant Flow|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin hydrochloride Oral Control Absorption System (TOCAS)tablets for 12 weeks.
1123479|NCT00507455|P2|Participant Flow|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin hydrochloride Oral Control Absorption System (TOCAS) tablets for 12 weeks.
1123480|NCT00507455|P1|Participant Flow|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
1123481|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123482|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123483|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
1123484|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123485|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123486|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
1123487|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123488|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123489|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
1123490|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123491|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123492|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
1123493|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123494|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123495|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
1123496|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123497|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123498|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
1123499|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123500|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123501|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
1123502|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123503|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123504|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
1123505|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123506|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123507|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
1123508|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123509|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123510|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
1123511|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123512|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123513|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
1123514|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123515|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123516|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
1123517|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123518|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123519|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
1123520|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123521|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123522|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
1123523|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123524|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123525|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
1123526|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123527|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123528|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
1123529|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123530|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123531|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
1123532|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123533|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123534|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
1123535|NCT00507455|E3|Reported Event|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123536|NCT00507455|E2|Reported Event|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
1123537|NCT00507455|E1|Reported Event|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
1123538|NCT00507442|B5|Baseline|Total|Total of all reporting groups
1123539|NCT00507442|B4|Baseline|VDC-mod|"Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
1123540|NCT00507442|B3|Baseline|V-DC|"VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
1123541|NCT00507442|B2|Baseline|VDCR|"VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 100 - 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
1123542|NCT00507442|B1|Baseline|V-DR|"VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
1123543|NCT00507442|P4|Participant Flow|VDC-mod|"Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
1123544|NCT00507442|P3|Participant Flow|V-DC|"VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
1123602|NCT00507429|O2|Outcome|Arm 2, Comparator: Carboplatin + Paclitaxel|Six 21-day cycles of carboplatin (AUC 6) and paclitaxel (200 mg/m2) on Day 1
1123603|NCT00507429|O1|Outcome|Arm 1, Active: CA4P + Carboplatin + Paclitaxel|Six 21-day cycles of CA4P (60 mg/m2) on days 1, 8, 15, carboplatin (AUC 6) and paclitaxel (200 mg/m2) on Day 2
1123545|NCT00507442|P2|Participant Flow|VDCR|"VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 100 - 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
1123546|NCT00507442|P1|Participant Flow|V-DR|"VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
1123547|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
1123548|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
1123645|NCT00507208|O2|Outcome|Control|Participants randomized to this arm will use tongue depressors for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint Trismus System for 3 months.
1123549|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
1123550|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
1123551|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
1123552|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
1123553|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
1123554|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
1123555|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
1123556|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
1123557|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
1123558|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
1123559|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
1123560|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
1123561|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
1123562|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
1123604|NCT00507429|E2|Reported Event|Arm 2, Comparator: Carboplatin + Paclitaxel|Six 21-day cycles of carboplatin (AUC 6) and paclitaxel (200 mg/m2) on Day 1
1123804|NCT00506662|B3|Baseline|Total|Total of all reporting groups
1123563|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
1123564|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
1123565|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
1123566|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
1123646|NCT00507208|O1|Outcome|Dynasplint|Participants randomized to this arm will be treated with the Dynasplint Trismus System
1123567|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
1123568|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
1123569|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
1123570|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
1123571|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
1123572|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
1123573|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
1123574|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
1123575|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
1123576|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
1123577|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
1123578|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
1123579|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
1123580|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
1123581|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
1123582|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
1123583|NCT00507442|O4|Outcome|VDC-mod|"Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
1123584|NCT00507442|O3|Outcome|V-DC|"VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
1123647|NCT00507208|E2|Reported Event|Control|Participants randomized to this arm will use tongue depressors for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint Trismus System for 3 months.
1123827|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
1123585|NCT00507442|O2|Outcome|VDCR|"VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 100 - 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
1123586|NCT00507442|O1|Outcome|V-DR|"VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
1123587|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
1123588|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
1123589|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
1123590|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
1123591|NCT00507442|E4|Reported Event|VDC-mod|"Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
1123592|NCT00507442|E3|Reported Event|V-DC|"VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
1123593|NCT00507442|E2|Reported Event|VDCR|"VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 100 - 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
1123594|NCT00507442|E1|Reported Event|V-DR|"VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
1123595|NCT00507429|B3|Baseline|Total|Total of all reporting groups
1123596|NCT00507429|B2|Baseline|Arm 2, Control: Carboplatin + Paclitaxel|On Day 2 of six 21-cycles subjects received Carboplatin (AUC 6) + paclitaxel (200 mg/m2). Subjects without progressive disease were followed monthly for survival.
1123597|NCT00507429|B1|Baseline|Arm 1, Active: CA4P + Carboplatin + Paclitaxel|Randomized 2:1 to receive six 21-day cycles of CA4P (60mg/m2)on days 1, 8, 15 + carboplatin (AUC 6) + paclitaxel (200 mg/m2) on Day 2. Subjects without progressive disease may continue maintenance CA4P infusions until progressive disease, then followed monthly for survival.
1123598|NCT00507429|P2|Participant Flow|Arm 2, Control: Carboplatin + Paclitaxel|On Day 2 of six 21-cycles subjects received Carboplatin (AUC 6) + paclitaxel (200 mg/m2). Subjects without progressive disease were followed monthly for survival.
1123599|NCT00507429|P1|Participant Flow|Arm 1, Active: CA4P + Carboplatin + Paclitaxel|Randomized 2:1 to receive six 21-day cycles of CA4P (60mg/m2)on days 1, 8, 15 + carboplatin (AUC 6) + paclitaxel (200 mg/m2) on Day 2. Subjects without progressive disease may continue maintenance CA4P infusions until progressive disease, then followed monthly for survival.
1123600|NCT00507429|O2|Outcome|Arm 2, Control: Carboplatin + Paclitaxel|On Day 2 of six 21-cycles subjects received Carboplatin (AUC 6) + paclitaxel (200 mg/m2). Subjects without progressive disease were followed monthly for survival.
1123601|NCT00507429|O1|Outcome|Arm 1, Active: CA4P + Carboplatin + Paclitaxel|Randomized 2:1 to receive six 21-day cycles of CA4P (60mg/m2)on days 1, 8, 15 + carboplatin (AUC 6) + paclitaxel (200 mg/m2) on Day 2. Subjects without progressive disease may continue maintenance CA4P infusions until progressive disease, then followed monthly for survival.
1123605|NCT00507429|E1|Reported Event|Arm 1, Active: CA4P + Carboplatin + Paclitaxel|Six 21-day cycles of CA4P (60 mg/m2) on days 1, 8, 15, carboplatin (AUC 6) and paclitaxel (200 mg/m2) on Day 2
1123606|NCT00507416|B4|Baseline|Total|Total of all reporting groups
1123607|NCT00507416|B3|Baseline|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
1123608|NCT00507416|B2|Baseline|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
1123609|NCT00507416|B1|Baseline|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
1123610|NCT00507416|P3|Participant Flow|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
1123611|NCT00507416|P2|Participant Flow|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
1123612|NCT00507416|P1|Participant Flow|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
1123613|NCT00507416|O3|Outcome|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
1123614|NCT00507416|O2|Outcome|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
1123615|NCT00507416|O1|Outcome|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
1123616|NCT00507416|O3|Outcome|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
1123617|NCT00507416|O2|Outcome|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
1123618|NCT00507416|O1|Outcome|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
1123619|NCT00507416|O3|Outcome|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
1123620|NCT00507416|O2|Outcome|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
1123621|NCT00507416|O1|Outcome|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
1123622|NCT00507416|O3|Outcome|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
1123712|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
1137282|NCT00467844|O1|Outcome|GTx-024 1 mg|
1123623|NCT00507416|O2|Outcome|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
1123624|NCT00507416|O1|Outcome|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
1123648|NCT00507208|E1|Reported Event|Dynasplint|Participants randomized to this arm will be treated with the Dynasplint Trismus System
1123726|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
1123625|NCT00507416|O3|Outcome|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
1123626|NCT00507416|O2|Outcome|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
1123627|NCT00507416|O1|Outcome|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
1123628|NCT00507416|O3|Outcome|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
1123629|NCT00507416|O2|Outcome|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
1123630|NCT00507416|O1|Outcome|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
1123631|NCT00507416|O3|Outcome|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
1123632|NCT00507416|O2|Outcome|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
1123633|NCT00507416|O1|Outcome|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
1123634|NCT00507416|O3|Outcome|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
1123635|NCT00507416|O2|Outcome|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
1123636|NCT00507416|O1|Outcome|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
1123637|NCT00507416|E3|Reported Event|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
1123638|NCT00507416|E2|Reported Event|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
1123639|NCT00507416|E1|Reported Event|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
1123640|NCT00507208|B3|Baseline|Total|Total of all reporting groups
1123641|NCT00507208|B2|Baseline|Control|Participants randomized to this arm will use tongue depressors for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint Trismus System for 3 months.
1123642|NCT00507208|B1|Baseline|Dynasplint|Participants randomized to this arm will be treated with the Dynasplint Trismus System
1123643|NCT00507208|P2|Participant Flow|Control|Participants randomized to this arm will use tongue depressors for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint Trismus System for 3 months.
1123644|NCT00507208|P1|Participant Flow|Dynasplint|Participants randomized to this arm will be treated with the Dynasplint Trismus System
1123649|NCT00503997|B1|Baseline|Pemetrexed/Oxaliplatin|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
1123650|NCT00503997|P1|Participant Flow|Pemetrexed/Oxaliplatin|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
1123651|NCT00503997|O1|Outcome|Pemetrexed/Oxaliplatin|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
1123652|NCT00503997|E1|Reported Event|Pemetrexed/Oxaliplatin|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
1123653|NCT00503984|B3|Baseline|Total|Total of all reporting groups
1123654|NCT00503984|B2|Baseline|Phase 2|All Phase 2 participants who received at least one dose of the combination of Azacitidine and Docetaxel with 5 mg of Prednisone at the recommended phase two dose level (RPTD).
1123655|NCT00503984|B1|Baseline|Phase 1|"All Phase 1 participants who received at least one dose of the combination of Azacitidine (Aza) and Docetaxel (Doc) and 5mg of Prednisone at one of the starting dose levels:~Level 1: 75 mg/m2 Aza + 60 mg/m2 Doc~Level 2: 75 mg/m2 Aza + 75 mg/m2 Doc~Level 3: 100 mg/m2 Aza + 75 mg/m2 Doc~Level 4: 150 mg/m2 Aza + 75 mg/m2 Doc"
1123656|NCT00503984|P6|Participant Flow|Phase 2 - Aza + Doc Reduced RPTD|All Phase 2 participants who received at least one reduced dose of the combination of Azacitidine and Docetaxel with 5 mg of Prednisone at the recommended phase two dose level (RPTD).
1123657|NCT00503984|P5|Participant Flow|Phase 2 - Aza + Doc Initial RPTD|All Phase 2 participants who received at least one dose of the combination of Azacitidine and Docetaxel with 5 mg of Prednisone at the recommended phase two dose level (RPTD).
1123658|NCT00503984|P4|Participant Flow|Phase 1: Level 4 - 150 Aza + 75 Doc|All Phase 1 participants who received at least one dose starting at the Level 4 dose combination of 150 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) and 5 mg of Prednisone.
1123659|NCT00503984|P3|Participant Flow|Phase 1: Level 3 - 100 Aza + 75 Doc|All Phase 1 participants who received at least one dose starting at the Level 3 dose combination of 100 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) and 5mg of Prednisone.
1123660|NCT00503984|P2|Participant Flow|Phase 1: Level 2 - 75 Aza + 75 Doc|All Phase 1 participants who received at least one dose starting at the Level 2 dose combination of 75 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) and 5mg of Prednisone.
1123661|NCT00503984|P1|Participant Flow|Phase 1: Level 1 - 75 Aza + 60 Doc|All Phase 1 participants who received at least one dose starting at the Level 1 dose combination of 75 mg/m^2 of Azacitidine (Aza), 60 mg/m^2 of Docetaxel (Doc) and 5mg of Prednisone.
1123662|NCT00503984|O4|Outcome|Level 4 - 150 Aza + 75 Doc|150 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
1123663|NCT00503984|O3|Outcome|Level 3 - 100 Aza + 75 Doc|100 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
1123664|NCT00503984|O2|Outcome|Level 2 - 75 Aza + 75 Doc|75 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
1123665|NCT00503984|O1|Outcome|Level 1 - 75 Aza + 60 Doc|75 mg/m2 of Azacitidine (Aza) and 60 mg/m2 of Docetaxel (Doc)
1123666|NCT00503984|O1|Outcome|All Study Participants|All study participants who received at least one dose of combination Azacitidine + Docetaxel, and 5 mg of Prednisone in either Phase 1 or Phase 2.
1123667|NCT00503984|O1|Outcome|All Study Participants|All study participants who received at least one dose of combination Azacitidine + Docetaxel, and 5 mg of Prednisone in either Phase 1 or Phase 2.
1123668|NCT00503984|O1|Outcome|All Study Participants Achieving PSA Response|All study participants who achieved PSA response to protocol therapy. PSA response according to PCWG1 is defined as an least 50 percent decline in PSA level from baseline that was maintained for at least three weeks.
1123669|NCT00503984|O5|Outcome|Phase 2 - Aza + Doc Initial RPTD|Initial Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel; and Prednisone; with optional growth factor support (pegfilgrastim/filgrastim).
1123670|NCT00503984|O4|Outcome|Phase 1: Level 4 - 150 Aza + 75 Doc|Phase 1, Starting Dose Level 4: 150 mg/m2 of Azacitidine (Aza), 75 mg/m2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
1123671|NCT00503984|O3|Outcome|Phase 1: Level 3 - 100 Aza + 75 Doc|Phase 1, Starting Dose Level 3: 100 mg/m2 of Azacitidine (Aza), 75 mg/m2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
1123672|NCT00503984|O2|Outcome|Phase 1: Level 2 - 75 Aza + 75 Doc|Phase 1, Starting Dose Level 2: 75 mg/m2 of Azacitidine (Aza), 75 mg/m2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
1123673|NCT00503984|O1|Outcome|Phase 1: Level 1 - 75 Aza + 60 Doc|Phase 1, Starting Dose Level 1: 75 mg/m2 of Azacitidine (Aza), 60 mg/m2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
1123674|NCT00503984|O6|Outcome|Phase 2 - Aza + Doc Reduced RPTD|All Phase 2 participants who received at least one reduced dose of the combination of Azacitidine and Docetaxel with 5 mg of Prednisone at the recommended phase two dose level (RPTD).
1123675|NCT00503984|O5|Outcome|Phase 2 - Aza + Doc Initial RPTD|Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel; and Prednisone; with optional growth factor support (pegfilgrastim/filgrastim).
1123676|NCT00503984|O4|Outcome|Phase 1: Level 4 - 150 Aza + 75 Doc|Phase 1, Starting Dose Level 1: 150 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
1133727|NCT00477269|O1|Outcome|STI571|STI571
1123677|NCT00503984|O3|Outcome|Phase 1: Level 3 - 100 Aza + 75 Doc|Phase 1, Starting Dose Level 3: 100 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
1123678|NCT00503984|O2|Outcome|Phase 1: Level 2 - 75 Aza + 75 Doc|Phase 1, Starting Dose Level 2: 75 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
1123679|NCT00503984|O1|Outcome|Phase 1: Level 1 - 75 Aza + 60 Doc|Phase 1, Starting Dose Level 1: 75 mg/m^2 of Azacitidine (Aza), 60 mg/m^2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
1123680|NCT00503984|O1|Outcome|Phase 1 - Aza + Doc|Phase 1 Azacitidine (Aza) and Docetaxel (Doc) with dose escalation/de-escalation design, and Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim).
1123681|NCT00503984|O1|Outcome|Phase 1 - Aza + Doc|Phase 1 Azacitidine (Aza) and Docetaxel (Doc) with dose escalation/de-escalation design, and Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim).
1123682|NCT00503984|E4|Reported Event|Level 4 - 150 Aza + 75 Doc|150 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
1123683|NCT00503984|E3|Reported Event|Level 3 - 100 Aza + 75 Doc|100 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
1123684|NCT00503984|E2|Reported Event|Level 2 - 75 Aza + 75 Doc|75 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
1123685|NCT00503984|E1|Reported Event|Level 1 - 75 Aza + 60 Doc|75 mg/m2 of Azacitidine (Aza) and 60 mg/m2 of Docetaxel (Doc)
1123686|NCT00507130|B5|Baseline|Total|Total of all reporting groups
1123687|NCT00507130|B4|Baseline|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
1123688|NCT00507130|B3|Baseline|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
1123689|NCT00507130|B2|Baseline|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
1123690|NCT00507130|B1|Baseline|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
1123691|NCT00507130|P4|Participant Flow|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
1123692|NCT00507130|P3|Participant Flow|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
1123693|NCT00507130|P2|Participant Flow|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
1123694|NCT00507130|P1|Participant Flow|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
1123695|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
1123696|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
1123697|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
1123698|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
1123699|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
1123700|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
1123701|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
1123702|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
1123703|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
1123704|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
1123705|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
1123706|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
1123707|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
1123708|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
1123709|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
1123710|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
1123711|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
1123713|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
1123714|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
1123715|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
1123716|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
1123717|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
1123718|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
1123719|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
1123720|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
1123721|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
1123722|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
1123723|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
1123727|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
1123728|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
1123729|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
1123730|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
1123731|NCT00507130|E4|Reported Event|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
1123732|NCT00507130|E3|Reported Event|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
1123733|NCT00507130|E2|Reported Event|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
1123734|NCT00507130|E1|Reported Event|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
1123735|NCT00506948|B1|Baseline|Thymoglobulin + Sirolimus + MMF|Thymoglobulin 1.5 mg/kg intravenous (IV) days -4, -3, -2, -1 before Stem Cell Transplant (Day 0); Sirolimus 6 mg IV on day -2 followed by 2 mg daily to maintain therapeutic levels and Mycophenolate Mofetil (MMF) 15 mg/kg IV or orally every 12 hours starting on day 0 until day+27.
1123736|NCT00506948|P1|Participant Flow|Thymoglobulin + Sirolimus + MMF|Thymoglobulin 1.5 mg/kg intravenous (IV) days -4, -3, -2, -1 before Stem Cell Transplant (Day 0); Sirolimus 6 mg IV on day -2 followed by 2 mg daily to maintain therapeutic levels and Mycophenolate Mofetil (MMF) 15 mg/kg IV or orally every 12 hours starting on day 0 until day+27.
1123737|NCT00506948|O1|Outcome|Thymoglobulin + Sirolimus + MMF|Thymoglobulin 1.5 mg/kg intravenous (IV) days -4, -3, -2, -1 before Stem Cell Transplant (Day 0); Sirolimus 6 mg IV on day -2 followed by 2 mg daily to maintain therapeutic levels and Mycophenolate Mofetil (MMF) 15 mg/kg IV or orally every 12 hours starting on day 0 until day+27.
1123738|NCT00506948|E1|Reported Event|Thymoglobulin + Sirolimus + MMF|Thymoglobulin 1.5 mg/kg intravenous (IV) days -4, -3, -2, -1 before Stem Cell Transplant (Day 0); Sirolimus 6 mg IV on day -2 followed by 2 mg daily to maintain therapeutic levels and Mycophenolate Mofetil (MMF) 15 mg/kg IV or orally every 12 hours starting on day 0 until day+27.
1123739|NCT00506922|B6|Baseline|Total|Total of all reporting groups
1123740|NCT00506922|B5|Baseline|Pentostatin 2|Group 5: Pentostatin 2 mg/m^2
1123741|NCT00506922|B4|Baseline|Pentostatin 1.5|Group 4: Pentostatin 1.5 mg/m^2
1123742|NCT00506922|B3|Baseline|Pentostatin 1|Group 3: Pentostatin 1 mg/m^2
1123743|NCT00506922|B2|Baseline|Pentostatin 0.5|Group 2: Pentostatin 0.5 mg/m^2
1123744|NCT00506922|B1|Baseline|No Pentostatin|Group 1: No Pentostatin
1123745|NCT00506922|P5|Participant Flow|Pentostatin 2|Group 5: Pentostatin 2 mg/m^2
1123746|NCT00506922|P4|Participant Flow|Pentostatin 1.5|Group 4: Pentostatin 1.5 mg/m^2
1123747|NCT00506922|P3|Participant Flow|Pentostatin 1|Group 3: Pentostatin 1 mg/m^2
1123748|NCT00506922|P2|Participant Flow|Pentostatin 0.5|Group 2: Pentostatin 0.5 mg/m^2
1123749|NCT00506922|P1|Participant Flow|No Pentostatin|Group 1: No Pentostatin
1123750|NCT00506922|O1|Outcome|Pentostatin|150 patients were enrolled, 2 patients not treated, 38 patients were Group 1 (no Pentostatin), the remaining Groups 2,3,4 and 5, 110 patients were analysed that received the Pentostatin.
1123751|NCT00506922|E5|Reported Event|Pentostatin 2|Group 5: Pentostatin 2 mg/m^2
1123752|NCT00506922|E4|Reported Event|Pentostatin 1.5|Group 4: Pentostatin 1.5 mg/m^2
1123753|NCT00506922|E3|Reported Event|Pentostatin 1|Group 3: Pentostatin 1 mg/m^2
1123754|NCT00506922|E2|Reported Event|Pentostatin 0.5|Group 2: Pentostatin 0.5 mg/m^2
1123755|NCT00506922|E1|Reported Event|No Pentostatin|Group 1: No Pentostatin
1123756|NCT00506883|B4|Baseline|Total|Total of all reporting groups
1123757|NCT00506883|B3|Baseline|Placebo|Two oral placebo capsules at onset of a confirmed gout flare followed by 1 oral placebo capsule every hour for an additional 6 hours.
1123758|NCT00506883|B2|Baseline|Low Dose Colchicine(MPC-004)|Low Dose Colchicine - 1.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) after 1 hours followed by placebo every hour thereafter hourly for 5 additional hours. All active doses were over encapsulated to mimic the appearance of the placebo.
1123759|NCT00506883|B1|Baseline|High Dose Colchicine(MPC-004)|Standard Dose Colchicine - 4.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) every hour for 6 hours. All doses were over encapsulated to mimic the appearance of the placebo.
1123760|NCT00506883|P3|Participant Flow|Placebo|Two oral placebo capsules at onset of a confirmed gout flare followed by 1 oral placebo capsule every hour for an additional 6 hours.
1123761|NCT00506883|P2|Participant Flow|Low Dose Colchicine(MPC-004)|Low Dose Colchicine - 1.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) after 1 hours followed by placebo every hour thereafter hourly for 5 additional hours. All active doses were over encapsulated to mimic the appearance of the placebo.
1123762|NCT00506883|P1|Participant Flow|High Dose Colchicine(MPC-004)|Standard Dose Colchicine - 4.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) every hour for 6 hours. All doses were over encapsulated to mimic the appearance of the placebo.
1123763|NCT00506883|O3|Outcome|Placebo|Two oral placebo capsules at onset of a confirmed gout flare followed by 1 oral placebo capsule every hour for an additional 6 hours.
1123764|NCT00506883|O2|Outcome|Low Dose Colchicine(MPC-004)|Low Dose Colchicine - 1.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) after 1 hours followed by placebo every hour thereafter hourly for 5 additional hours. All active doses were over encapsulated to mimic the appearance of the placebo.
1123765|NCT00506883|O1|Outcome|High Dose Colchicine(MPC-004)|Standard Dose Colchicine - 4.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) every hour for 6 hours. All doses were over encapsulated to mimic the appearance of the placebo.
1123766|NCT00506883|E3|Reported Event|Placebo|Two oral placebo capsules at onset of a confirmed gout flare followed by 1 oral placebo capsule every hour for an additional 6 hours.
1123767|NCT00506883|E2|Reported Event|Low Dose Colchicine(MPC-004)|Low Dose Colchicine - 1.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) after 1 hours followed by placebo every hour thereafter hourly for 5 additional hours. All active doses were over encapsulated to mimic the appearance of the placebo.
1123768|NCT00506883|E1|Reported Event|High Dose Colchicine(MPC-004)|Standard Dose Colchicine - 4.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) every hour for 6 hours. All doses were over encapsulated to mimic the appearance of the placebo.
1123769|NCT00506857|B1|Baseline|Busulfan + Fludarabine|Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m^2 IV daily for 4 days.
1123770|NCT00506857|P1|Participant Flow|Busulfan + Fludarabine|Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m^2 IV daily for 4 days.
1123771|NCT00506857|O1|Outcome|Tacrolimus + Methotrexate|Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m^2 IV daily for 4 days.
1123772|NCT00506857|O1|Outcome|Busulfan + Fludarabine|Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m^2 IV daily for 4 days.
1123773|NCT00506857|E1|Reported Event|Busulfan + Fludarabine|Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m^2 IV daily for 4 days.
1123774|NCT00506831|B1|Baseline|Imatinib Mesylate|
1123775|NCT00506831|P1|Participant Flow|Imatinib Mesylate|
1123776|NCT00506831|O1|Outcome|Imatinib Mesylate|All patients were treated with imatinib mesylate at a mean dosage of 300 mg daily.
1123777|NCT00506831|E1|Reported Event|Imatinib Mesylate|
1123778|NCT00506714|B3|Baseline|Total|Total of all reporting groups
1123779|NCT00506714|B2|Baseline|Group 2|Adults with symptomatic hip osteoarthritis
1123780|NCT00506714|B1|Baseline|Group 1|Healthy adults
1123781|NCT00506714|P2|Participant Flow|Group 2|Adults with symptomatic hip osteoarthritis
1123782|NCT00506714|P1|Participant Flow|Group 1|Healthy adults
1123783|NCT00506714|O1|Outcome|Group 2|Adults with symptomatic hip osteoarthritis after four weeks of cane use
1123784|NCT00506714|O1|Outcome|Group 2|Adults with symptomatic hip osteoarthritis walking with a cane at baseline
1123785|NCT00506714|O2|Outcome|Group 2|Adults with symptomatic hip osteoarthritis walking without a cane at baseline
1123786|NCT00506714|O1|Outcome|Group 1|Healthy adults walking without a cane at baseline
1123787|NCT00506714|E2|Reported Event|Group 2|Adults with symptomatic hip osteoarthritis
1123788|NCT00506714|E1|Reported Event|Group 1|Healthy adults
1123789|NCT00506675|B3|Baseline|Total|Total of all reporting groups
1123790|NCT00506675|B2|Baseline|Weaning|For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
1123791|NCT00506675|B1|Baseline|Intensive|6 hours daily patching combined with daily atropine
1123792|NCT00506675|P2|Participant Flow|Weaning|For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
1123793|NCT00506675|P1|Participant Flow|Intensive|6 hours daily patching combined with daily atropine
1123794|NCT00506675|O2|Outcome|Weaning|For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
1123795|NCT00506675|O1|Outcome|Intensive|6 hours daily patching combined with daily atropine
1123796|NCT00506675|O2|Outcome|Weaning|For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
1123797|NCT00506675|O1|Outcome|Intensive|6 hours daily patching combined with daily atropine
1123798|NCT00506675|O2|Outcome|Weaning|For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
1123799|NCT00506675|O1|Outcome|Intensive|6 hours daily patching combined with daily atropine
1123800|NCT00506675|O2|Outcome|Weaning|For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
1123801|NCT00506675|O1|Outcome|Intensive|6 hours daily patching combined with daily atropine
1123802|NCT00506675|E2|Reported Event|Weaning|For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
1123805|NCT00506662|B2|Baseline|Insulin NPH|Individually adjusted dose of insulin NPH once daily
1123806|NCT00506662|B1|Baseline|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
1123807|NCT00506662|P2|Participant Flow|Insulin NPH|Individually adjusted dose of insulin NPH once daily
1123808|NCT00506662|P1|Participant Flow|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
1123809|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
1123810|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
1123811|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
1123812|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
1123813|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
1123814|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
1123815|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
1123816|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
1123817|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
1123818|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
1123819|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
1123820|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
1123828|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
1123829|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
1123830|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
1123831|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
1123832|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
1123833|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
1123834|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
1123835|NCT00506662|E2|Reported Event|Insulin NPH|Individually adjusted dose of insulin NPH once daily
1123836|NCT00506662|E1|Reported Event|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
1123837|NCT00506597|B1|Baseline|Erwinase|6 doses of 25,000 Units/m^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase
1123838|NCT00506597|P1|Participant Flow|Erwinase|6 doses of 25,000 Units/m^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase
1123839|NCT00506597|O1|Outcome|Erwinase|6 doses of 25,000 Units/m^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase
1123840|NCT00506597|E1|Reported Event|Erwinase|6 doses of 25,000 Units/m^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase
1123841|NCT00506493|B1|Baseline|Study Completion Cohort|75 subjects were enrolled and treated. 64 subjects completed the study through the 9 month follow-up. 6 subjects died and 5 subjects withdrew from the study.
1123842|NCT00506493|P1|Participant Flow|Cardioblate Surgical Ablation System|75 subjects were enrolled and treated. 64 subjects completed the study through the 9 month follow-up. 6 subjects died and 5 subjects withdrew from the study.
1123843|NCT00506493|O1|Outcome|Cardioblate Surgical Ablation System|75 subjects were enrolled and treated with the Cardioblate Surgical Ablation System.. 64 subjects completed the study through the 9 month follow-up. 6 subjects died and 5 subjects withdrew from the study.
1123844|NCT00506493|O1|Outcome|Cardioblate Surgical Ablation System|75 subjects were enrolled and treated with the Cardioblate Surgical Ablation System.. 64 subjects completed the study through the 9 month follow-up. 6 subjects died and 5 subjects withdrew from the study.
1123845|NCT00506493|O1|Outcome|Cardioblate Surgical Ablation System|All subjects who underwent surgical ablation with the Cardioblate Surgical Ablation System.
1123846|NCT00506493|O1|Outcome|Cardioblate Surgical Ablation System|All subjects enrolled who underwent surgical ablation with the Cardioblate Surgical Ablation system and completed a Holter assessment at 9 month follow-up
1123847|NCT00506493|E1|Reported Event|Study Completion Cohort|75 subjects were enrolled and treated. 64 subjects completed the study through the 9 month follow-up. 6 subjects died and 5 subjects withdrew from the study.
1123848|NCT00506454|B3|Baseline|Total|Total of all reporting groups
1123849|NCT00506454|B2|Baseline|Placebo|Participants receiving the placebo.
1123850|NCT00506454|B1|Baseline|Active|Participants receiving the active drug.
1123851|NCT00506454|P2|Participant Flow|Placebo|Participants receiving the placebo.
1123852|NCT00506454|P1|Participant Flow|Active|Participants receiving the active drug.
1123853|NCT00506454|O2|Outcome|Placebo|Participants receiving the placebo.
1123854|NCT00506454|O1|Outcome|Treatment|Participants receiving the active drug.
1123855|NCT00506454|E2|Reported Event|Placebo|Participants receiving the placebo.
1123856|NCT00506454|E1|Reported Event|Active|Participants receiving the active drug.
1123857|NCT00506441|B1|Baseline|MCI-196|"Open-label Period (Week 0 - 12) ; 3, 6, 9, 12, or 15 g/ day as titrated~Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period"
1123858|NCT00506441|P2|Participant Flow|Placebo|Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period
1123859|NCT00506441|P1|Participant Flow|MCI-196|"Open-label Period (Week 0 -12) ; 3, 6, 9, 12, or 15 g/ day as titrated~Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period"
1123860|NCT00506441|O1|Outcome|MCI-196 (Open-label Period)|3, 6, 9, 12, or 15g/day as titrated (Week 0 -12)
1123861|NCT00506441|O2|Outcome|Placebo (Double-blind Period)|Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period
1123862|NCT00506441|O1|Outcome|MCI-196 (Double-blind Period)|Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period
1123863|NCT00506441|E3|Reported Event|Placebo (Double-blind Period)|"dose level at the end of dose titration in the Open-label period (Week 12-16)~One subject who was randomized to placebo and another subject who was randomized to MCI-196 took both placebo and MCI-196 during the double-blind period. They have therefore been included in the MCI-196 group for the safety evaluation for the double-blind period."
1123864|NCT00506441|E2|Reported Event|MCI-196 (Double-blind Period)|"dose level at the end of dose titration in the Open-label period (Week 12-16)~One subject who was randomized to placebo and another subject who was randomized to MCI-196 took both placebo and MCI-196 during the double-blind period. They have therefore been included in the MCI-196 group for the safety evaluation for the double-blind period."
1123865|NCT00506441|E1|Reported Event|MCI-196 (Open-label Period)|3, 6, 9, 12, or 15 g/ day as titrated (Week 0-12)
1123866|NCT00506415|B1|Baseline|Total Patients|Total number of patients enrolled in the initial open label period that may have been randomized in the double blind period or may have continued in the extended open label period.
1123867|NCT00506415|P4|Participant Flow|Extended Open Label (10 cm^2)|Rivastigmine 10 cm^2 transdermal patch once a day during 48 weeks (from week 48 to week 96) open label treatment.
1123868|NCT00506415|P3|Participant Flow|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.
1123869|NCT00506415|P2|Participant Flow|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
1124102|NCT00505518|O1|Outcome|Telepsychiatry|Telepsychiatry-based follow up visits with psychiatrist.
1133728|NCT00477269|O2|Outcome|Placebo|Placebo
1123870|NCT00506415|P1|Participant Flow|Initial Open Label: Rivastigmine (5 cm^2 / 10 cm^2)|Rivastigmine 5 cm^2 transdermal patch once a day during the first 4 weeks of open label treatment followed by rivastigmine 10 cm^2 transdermal patch once a day from week 4 to week 24, 36 or 48.
1123871|NCT00506415|O4|Outcome|Extended Open Label (10 cm^2)|Rivastigmine 10 cm^2 transdermal patch once a day during 48 weeks open label treatment running in parallel to the double blind period.
1123872|NCT00506415|O3|Outcome|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15c m^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.
1123873|NCT00506415|O2|Outcome|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
1123874|NCT00506415|O1|Outcome|Initial Open Label: Rivastigmine (5 cm^2 / 10 cm^2)|Rivastigmine 5 cm^2 transdermal patch once a day during the first 4 weeks of open label treatment followed by rivastigmine 10 cm^2 transdermal patch once a day from week 4 to week 24, 36 or 48.
1123875|NCT00506415|O2|Outcome|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.
1123876|NCT00506415|O1|Outcome|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
1123877|NCT00506415|O2|Outcome|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
1123878|NCT00506415|O1|Outcome|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during the double blind period.
1123879|NCT00506415|O2|Outcome|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.
1123880|NCT00506415|O1|Outcome|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
1123881|NCT00506415|O2|Outcome|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.
1123882|NCT00506415|O1|Outcome|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
1123883|NCT00506415|O2|Outcome|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.
1123884|NCT00506415|O1|Outcome|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
1123885|NCT00506415|O2|Outcome|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.
1123886|NCT00506415|O1|Outcome|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
1123887|NCT00506415|E4|Reported Event|Extended Open Label: Rivastigmine (10 cm^2)|Safety population Extended Open Label (Safety-EOL) - This population consisted of all patients who received at least 1 dose of study drug during the extended open label phase and had at least 1 post baseline safety assessment during the same phase.
1123888|NCT00506415|E3|Reported Event|Double Blind: Rivastigmine (15 cm^2)|Safety population Double Blind (Safety-DB) - This population included all patients who were randomized, received at least 1 dose of study drug during the double blind phase and had at least 1 post-randomization safety assessment during the double blind phase. Patients were analyzed according to treatment received.
1123889|NCT00506415|E2|Reported Event|Double Blind: Rivastigmine (10 cm^2)|Safety population Double Blind (Safety-DB) - This population included all patients who were randomized, received at least 1 dose of study drug during the double blind phase and had at least 1 post-randomization safety assessment during the double blind phase. Patients were analyzed according to treatment received.
1124020|NCT00505765|P1|Participant Flow|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
1123890|NCT00506415|E1|Reported Event|Initial Open Label: Rivastigmine (5 cm^2 / 10 cm^2)|Safety population Initial Open Label (Safety-IOL) - This population consisted of all patients who received at least 1 dose of study drug during the initial open label phase and had at least 1 post baseline safety assessment during the same phase.
1123891|NCT00506389|B4|Baseline|Total|Total of all reporting groups
1123892|NCT00506389|B3|Baseline|Placebo|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
1123893|NCT00506389|B2|Baseline|Esmirtazapine 4.5 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
1123894|NCT00506389|B1|Baseline|Esmirtazapine 3.0 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
1123895|NCT00506389|P3|Participant Flow|Placebo|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
1123896|NCT00506389|P2|Participant Flow|Esmirtazapine 4.5 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
1123897|NCT00506389|P1|Participant Flow|Esmirtazapine 3.0 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
1123898|NCT00506389|O3|Outcome|Placebo|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
1123899|NCT00506389|O2|Outcome|Esmirtazapine 4.5 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
1123900|NCT00506389|O1|Outcome|Esmirtazapine 3.0 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
1123901|NCT00506389|O3|Outcome|Placebo|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
1123902|NCT00506389|O2|Outcome|Esmirtazapine 4.5 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
1123903|NCT00506389|O1|Outcome|Esmirtazapine 3.0 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
1123904|NCT00506389|O3|Outcome|Placebo|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
1123905|NCT00506389|O2|Outcome|Esmirtazapine 4.5 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
1123906|NCT00506389|O1|Outcome|Esmirtazapine 3.0 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
1123907|NCT00506389|E6|Reported Event|Placebo Follow-up|After participants received placebo tablets during the Placebo Washout Period and placebo during the In-treatment Period, participants were followed for safety up to Day 50 during the Follow-up Period.
1123908|NCT00506389|E5|Reported Event|Esmirtazapine 4.5 mg Follow-up|After participants received placebo tablets during the Placebo Washout Period and 4.5 mg esmirtazapine during the In-treatment Period, participants were followed for safety up to Day 50 during the Follow-up Period.
1123909|NCT00506389|E4|Reported Event|Esmirtazapine 3.0 mg Follow-up|After participants received placebo tablets during the Placebo Washout Period and 3.0 mg esmirtazapine during the In-treatment Period, participants were followed for safety up to Day 50 during the Follow-up Period.
1123910|NCT00506389|E3|Reported Event|Placebo In-treatment|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. Tablets were taken by mouth once daily in the evening.
1123911|NCT00506389|E2|Reported Event|Esmirtazapine 4.5 mg In-treatment|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. Tablets were taken by mouth once daily in the evening.
1124021|NCT00505765|O3|Outcome|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)~Data were combined across placebo conditions for analysis"
1123912|NCT00506389|E1|Reported Event|Esmirtazapine 3.0 mg In-treatment|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. Tablets were taken by mouth once daily in the evening.
1123913|NCT00506285|B3|Baseline|Total|Total of all reporting groups
1123914|NCT00506285|B2|Baseline|B Placebo Patch Was Used First|Placebo patch was used in the first treatment arm and MTS in the second treatment arm.
1123915|NCT00506285|B1|Baseline|a) Methylphenidate Transdermal System Was Taken First|Subjects took Methylphenidate Transdermal System in the first treatment arm and placebo patch in the second treatment arm
1123916|NCT00506285|P2|Participant Flow|B) PBO Arm Was 1st and MTS Arm Was 2nd|Placebo was initiated using a 12.5cm2 patch then increased to the highest possible tolerated dose within two weeks and held at that level for the final two weeks of the first 4-week arm. In the second double-blind arm subjects were started using a 12.5cm2 MTS patch, which was increased to the highest tolerated dose within two weeks and held at that level for the final two weeks of the second 4-week arm.
1123917|NCT00506285|P1|Participant Flow|A) MTS Arm Was 1st and PBO Arm Was 2nd|MTS was initiated using a 12.5cm2 patch then increased to the highest possible tolerated dose within two weeks and held at that level for the final two weeks of the first 4-week arm. In the second double-blind arm subjects were started using a 12.5cm2 placebo patch, which was increased to the highest tolerated dose within two weeks and held at that level for the final two weeks of the second 4-week arm.
1123918|NCT00506285|O2|Outcome|Scores in Placebo Arm|Average CAARS score at end of placebo treatment
1123919|NCT00506285|O1|Outcome|Scores in MTS Arm|Average CAARS score at end of active treatment
1123920|NCT00506285|O2|Outcome|Scores in Placebo Arm|Average WRAADDS scores at end of placebo arm
1123921|NCT00506285|O1|Outcome|Scores in MTS Arm|Average WRAADDS scores at end of active treatment (MTS) arm
1123922|NCT00506285|E2|Reported Event|Placebo Arm|Adverse events and Serious AEs during placebo arm
1123923|NCT00506285|E1|Reported Event|MTS Arm|Adverse events and Serious AEs during active treatment (MTS) arm
1124103|NCT00505518|O1|Outcome|Telepsychiatry|Telepsychiatry-based follow up visits with psychiatrist.
1123924|NCT00506155|B1|Baseline|Neoadjuvant Chemotherapy With M-VAC + Avastin|Avastin 10 mg/kg intravenous (IV) over 90 minutes. Cisplatin 70 mg/m^2 IV over 4 hours. Doxorubicin 30 mg/m^2 IV over 15 minutes. Methotrexate 30 mg/m^2 IV over 30 minutes. Vinblastine Sulfate 3 mg/m^2 IV over 30 minutes.
1123925|NCT00506155|P1|Participant Flow|Neoadjuvant Chemotherapy With M-VAC + Avastin|Avastin 10 mg/kg intravenous (IV) over 90 minutes. Cisplatin 70 mg/m^2 IV over 4 hours. Doxorubicin 30 mg/m^2 IV over 15 minutes. Methotrexate 30 mg/m^2 IV over 30 minutes. Vinblastine Sulfate 3 mg/m^2 IV over 30 minutes.
1123926|NCT00506155|O1|Outcome|Neoadjuvant Chemotherapy With M-VAC + Avastin|Avastin 10 mg/kg intravenous (IV) over 90 minutes. Cisplatin 70 mg/m^2 IV over 4 hours. Doxorubicin 30 mg/m^2 IV over 15 minutes. Methotrexate 30 mg/m^2 IV over 30 minutes. Vinblastine Sulfate 3 mg/m^2 IV over 30 minutes.
1123927|NCT00506155|O1|Outcome|Neoadjuvant Chemotherapy With M-VAC + Avastin|Avastin 10 mg/kg intravenous (IV) over 90 minutes. Cisplatin 70 mg/m^2 IV over 4 hours. Doxorubicin 30 mg/m^2 IV over 15 minutes. Methotrexate 30 mg/m^2 IV over 30 minutes. Vinblastine Sulfate 3 mg/m^2 IV over 30 minutes.
1123928|NCT00506155|E1|Reported Event|Neoadjuvant Chemotherapy With M-VAC + Avastin|Avastin 10 mg/kg intravenous (IV) over 90 minutes. Cisplatin 70 mg/m^2 IV over 4 hours. Doxorubicin 30 mg/m^2 IV over 15 minutes. Methotrexate 30 mg/m^2 IV over 30 minutes. Vinblastine Sulfate 3 mg/m^2 IV over 30 minutes.
1123929|NCT00506077|B3|Baseline|Total|Total of all reporting groups
1123930|NCT00506077|B2|Baseline|Placebo Then MK0249|These subjects received Placebo during Treatment Period 1 and MK0249 during Treatment Period 2.
1123931|NCT00506077|B1|Baseline|MK0249 Then Placebo|These subjects received MK0249 during Treatment Period 1 and Placebo during Treatment Period 2.
1123932|NCT00506077|P2|Participant Flow|Placebo Then MK0249|These subjects received Placebo during Treatment Period 1 and MK0249 during Treatment Period 2.
1123933|NCT00506077|P1|Participant Flow|MK0249 Then Placebo|These subjects received MK0249 during Treatment Period 1 and Placebo during Treatment Period 2.
1123934|NCT00506077|O2|Outcome|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
1123935|NCT00506077|O1|Outcome|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
1123936|NCT00506077|O2|Outcome|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
1123937|NCT00506077|O1|Outcome|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
1123938|NCT00506077|O2|Outcome|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
1123939|NCT00506077|O1|Outcome|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
1123940|NCT00506077|O2|Outcome|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
1123941|NCT00506077|O1|Outcome|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
1123942|NCT00506077|O2|Outcome|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
1123943|NCT00506077|O1|Outcome|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
1123944|NCT00506077|O2|Outcome|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
1123945|NCT00506077|O1|Outcome|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
1123946|NCT00506077|O2|Outcome|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
1124168|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
1123947|NCT00506077|O1|Outcome|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
1123948|NCT00506077|O2|Outcome|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
1123949|NCT00506077|O1|Outcome|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
1123950|NCT00506077|E2|Reported Event|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
1123951|NCT00506077|E1|Reported Event|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
1123952|NCT00506064|B3|Baseline|Total|Total of all reporting groups
1123953|NCT00506064|B2|Baseline|Placebo|Starch capsules by mouth daily
1123954|NCT00506064|B1|Baseline|Melatonin|0.15 mg/kg capsules by mouth daily
1123955|NCT00506064|P2|Participant Flow|Placebo|Starch capsules by mouth daily
1123956|NCT00506064|P1|Participant Flow|Melatonin|0.15 mg/kg capsules by mouth daily
1123957|NCT00506064|O2|Outcome|Placebo|Starch capsules by mouth daily
1123958|NCT00506064|O1|Outcome|Melatonin|0.15 mg/kg capsules by mouth daily
1123959|NCT00506064|E2|Reported Event|Placebo|Starch capsules by mouth daily
1123960|NCT00506064|E1|Reported Event|Melatonin|0.15 mg/kg capsules by mouth daily
1123961|NCT00506025|B4|Baseline|Total|Total of all reporting groups
1123962|NCT00506025|B3|Baseline|Placebo 2xday|Placebo two times daily (P, P; n = 8 pregnant)
1123963|NCT00506025|B2|Baseline|Cranberry + Placebo|Cranberry in the a.m., then placebo (P) in the p.m. (C, P; n = 9 pregnant)
1123964|NCT00506025|B1|Baseline|Cranberry 2xday|Cranberry (C) two times daily (C, C; n = 10 pregnant)
1123965|NCT00506025|P3|Participant Flow|Placebo 2xday|Placebo two times daily (P, P; n = 8 pregnant)
1123966|NCT00506025|P2|Participant Flow|Cranberry + Placebo|Cranberry in the a.m., then placebo (P) in the p.m. (C, P; n = 9 pregnant)
1123967|NCT00506025|P1|Participant Flow|Cranberry 2xday|Cranberry (C) two times daily (C, C; n = 10 pregnant)
1123968|NCT00506025|O3|Outcome|Placebo 2xday|Placebo two times daily (P, P; n = 8 pregnant)
1123969|NCT00506025|O2|Outcome|Cranberry + Placebo|Cranberry in the a.m., then placebo (P) in the p.m. (C, P; n = 9 pregnant)
1123970|NCT00506025|O1|Outcome|Cranberry 2xday|Cranberry (C) two times daily (C, C; n = 10 pregnant)
1123971|NCT00506025|E3|Reported Event|Placebo 2xday|Placebo two times daily (P, P; n = 8 pregnant)
1123972|NCT00506025|E2|Reported Event|Cranberry + Placebo|Cranberry in the a.m., then placebo (P) in the p.m. (C, P; n = 9 pregnant)
1123973|NCT00506025|E1|Reported Event|Cranberry 2xday|Cranberry (C) two times daily (C, C; n = 10 pregnant)
1124022|NCT00505765|O2|Outcome|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
1124023|NCT00505765|O1|Outcome|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
1124024|NCT00505765|O3|Outcome|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)~Data were combined across placebo conditions for analysis"
1124025|NCT00505765|O2|Outcome|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
1124026|NCT00505765|O1|Outcome|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
1123974|NCT00505934|B1|Baseline|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).~For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily)."
1123975|NCT00505934|P1|Participant Flow|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).~For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily)."
1123987|NCT00505895|P2|Participant Flow|Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 IV daily over 30 minutes for 4 Days (Beginning Day -4).~Lower-Dose Melphalan 100 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
1123988|NCT00505895|P1|Participant Flow|Fludarabine + Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4).~Melphalan 140 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
1124223|NCT00505076|B3|Baseline|Placebo BID|Subjects treated with 2 tablets placebo BID (twice daily)
1123976|NCT00505934|O1|Outcome|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).~For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily)."
1123977|NCT00505934|O1|Outcome|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).~For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily)."
1123978|NCT00505934|O1|Outcome|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).~For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily)."
1123979|NCT00505934|E1|Reported Event|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).~For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily)."
1123980|NCT00505921|B1|Baseline|Campath-1H|"3 mg in vivo Day 1; 10 mg Day 2; 30 mg Days 3 and 10 of chemotherapy treatment. Transplantation on Day 0.~Preparative Regimen For Autologous Stem Cell Transplantation: BEAM (BCNU 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice on day -5 to -2 (total 8 doses), and Melphalan 140 mg/m2 IV on day -1. Beginning on day +5 G-CSF 10 mg/kg sc (in a.m.) and GM-SCF 250 m/m2 on Day +5 (in p.m.)~Preparative Regimen For Allogenic Stem Cell Transplantation: Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy day 0."
1123981|NCT00505921|P1|Participant Flow|Campath-1H|"3 mg in vivo Day 1; 10 mg Day 2; 30 mg Days 3 and 10 of chemotherapy treatment. Transplantation on Day 0.~Preparative Regimen For Autologous Stem Cell Transplantation: BEAM (BCNU 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice on day -5 to -2 (total 8 doses), and Melphalan 140 mg/m2 IV on day -1. Beginning on day +5 G-CSF 10 mg/kg sc (in a.m.) and GM-SCF 250 m/m2 on Day +5 (in p.m.)~Preparative Regimen For Allogenic Stem Cell Transplantation: Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy day 0."
1123982|NCT00505921|O1|Outcome|Campath-1H|"3 mg in vivo Day 1; 10 mg Day 2; 30 mg Days 3 and 10 of chemotherapy treatment. Transplantation on Day 0.~Preparative Regimen For Autologous Stem Cell Transplantation: BEAM (BCNU 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice on day -5 to -2 (total 8 doses), and Melphalan 140 mg/m2 IV on day -1. Beginning on day +5 G-CSF 10 mg/kg sc (in a.m.) and GM-SCF 250 m/m2 on Day +5 (in p.m.)~Preparative Regimen For Allogenic Stem Cell Transplantation: Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy day 0."
1124027|NCT00505765|O3|Outcome|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)~Data were combined across placebo conditions for analysis"
1124028|NCT00505765|O2|Outcome|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
1124029|NCT00505765|O1|Outcome|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
1123983|NCT00505921|E1|Reported Event|Campath-1H|"3 mg in vivo Day 1; 10 mg Day 2; 30 mg Days 3 and 10 of chemotherapy treatment. Transplantation on Day 0.~Preparative Regimen For Autologous Stem Cell Transplantation: BEAM (BCNU 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice on day -5 to -2 (total 8 doses), and Melphalan 140 mg/m2 IV on day -1. Beginning on day +5 G-CSF 10 mg/kg sc (in a.m.) and GM-SCF 250 m/m2 on Day +5 (in p.m.)~Preparative Regimen For Allogenic Stem Cell Transplantation: Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy day 0."
1123984|NCT00505895|B3|Baseline|Total|Total of all reporting groups
1123985|NCT00505895|B2|Baseline|Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 intravenous daily over 30 minutes for 4 Days (Beginning Day -4).~Lower-Dose Melphalan 100 mg/m^2 intravenous over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 intravenous infused starting on day -5."
1123986|NCT00505895|B1|Baseline|Fludarabine + Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4).~Melphalan 140 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
1123989|NCT00505895|O2|Outcome|Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 IV daily over 30 minutes for 4 Days (Beginning Day -4).~Lower-Dose Melphalan 100 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
1123990|NCT00505895|O1|Outcome|Fludarabine + Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4).~Melphalan 140 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
1123991|NCT00505895|O2|Outcome|Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 IV daily over 30 minutes for 4 Days (Beginning Day -4).~Lower-Dose Melphalan 100 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
1123992|NCT00505895|O1|Outcome|Fludarabine + Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4).~Melphalan 140 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
1123993|NCT00505895|E2|Reported Event|Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 IV daily over 30 minutes for 4 Days (Beginning Day -4).~Lower-Dose Melphalan 100 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
1123994|NCT00505895|E1|Reported Event|Fludarabine + Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4).~Melphalan 140 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
1123995|NCT00505778|B3|Baseline|Total|Total of all reporting groups
1123996|NCT00505778|B2|Baseline|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
1123997|NCT00505778|B1|Baseline|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
1123998|NCT00505778|P2|Participant Flow|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
1123999|NCT00505778|P1|Participant Flow|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
1124000|NCT00505778|O2|Outcome|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
1124001|NCT00505778|O1|Outcome|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
1124002|NCT00505778|O2|Outcome|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
1124003|NCT00505778|O1|Outcome|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
1124004|NCT00505778|O2|Outcome|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
1124005|NCT00505778|O1|Outcome|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
1124006|NCT00505778|O2|Outcome|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
1124007|NCT00505778|O1|Outcome|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
1124008|NCT00505778|O2|Outcome|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
1124009|NCT00505778|O1|Outcome|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
1124010|NCT00505778|O2|Outcome|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
1124011|NCT00505778|O1|Outcome|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
1124012|NCT00505778|E2|Reported Event|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
1124013|NCT00505778|E1|Reported Event|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
1124014|NCT00505765|B4|Baseline|Total|Total of all reporting groups
1124015|NCT00505765|B3|Baseline|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)~Data were combined across placebo conditions for analysis"
1124016|NCT00505765|B2|Baseline|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
1124017|NCT00505765|B1|Baseline|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
1124018|NCT00505765|P3|Participant Flow|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)~Data were combined across placebo conditions for analysis"
1124019|NCT00505765|P2|Participant Flow|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
1124030|NCT00505765|O3|Outcome|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)~Data were combined across placebo conditions for analysis"
1124031|NCT00505765|O2|Outcome|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
1124032|NCT00505765|O1|Outcome|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
1124033|NCT00505765|O3|Outcome|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)~Data were combined across placebo conditions for analysis"
1124034|NCT00505765|O2|Outcome|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
1124035|NCT00505765|O1|Outcome|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
1124036|NCT00505765|O3|Outcome|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)~Data were combined across placebo conditions for analysis"
1124037|NCT00505765|O2|Outcome|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
1124038|NCT00505765|O1|Outcome|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
1124039|NCT00505765|E3|Reported Event|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)~Data were combined across placebo conditions for analysis"
1124040|NCT00505765|E2|Reported Event|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
1124041|NCT00505765|E1|Reported Event|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
1124042|NCT00505752|B5|Baseline|Total|Total of all reporting groups
1133729|NCT00477269|O1|Outcome|STI571|STI571
1124043|NCT00505752|B4|Baseline|Follitropin Alfa 150 IU|Follitropin alfa (Gonal-f®) 150 IU administered subcutaneously once daily from S1 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
1124044|NCT00505752|B3|Baseline|AS900672-Enriched 150 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
1124045|NCT00505752|B2|Baseline|AS900672-Enriched 100 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
1124046|NCT00505752|B1|Baseline|AS900672-Enriched 50 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 50 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 150 international unit (IU) subcutaneously starting from Stimulation Day 6 (S6) up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of greater than or equal to [>=] 18 millimeter [mm], two or more additional follicles with a diameter of >= 16 mm, and Estradiol [E2] levels were approximately 150 picogram per milliliter [pg/mL] per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
1124047|NCT00505752|P4|Participant Flow|Follitropin Alfa 150 IU|Follitropin alfa (Gonal-f®) 150 IU administered subcutaneously once daily from S1 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
1124048|NCT00505752|P3|Participant Flow|AS900672-Enriched 150 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
1124049|NCT00505752|P2|Participant Flow|AS900672-Enriched 100 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
1124082|NCT00505622|P2|Participant Flow|Perampanel (Entacapone 200mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
1124050|NCT00505752|P1|Participant Flow|AS900672-Enriched 50 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 50 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 150 international unit (IU) subcutaneously starting from Stimulation Day 6 (S6) up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of greater than or equal to [>=] 18 millimeter [mm], two or more additional follicles with a diameter of >= 16 mm, and Estradiol [E2] levels were approximately 150 picogram per milliliter [pg/mL] per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
1124051|NCT00505752|O4|Outcome|Follitropin Alfa 150 IU|Follitropin alfa (Gonal-f®) 150 IU administered subcutaneously once daily from S1 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
1124085|NCT00505622|O2|Outcome|Perampanel (Entacapone 200mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
1124052|NCT00505752|O3|Outcome|AS900672-Enriched 150 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
1124053|NCT00505752|O2|Outcome|AS900672-Enriched 100 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
1124054|NCT00505752|O1|Outcome|AS900672-Enriched 50 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 50 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 150 international unit (IU) subcutaneously starting from Stimulation Day 6 (S6) up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of greater than or equal to [>=] 18 millimeter [mm], two or more additional follicles with a diameter of >= 16 mm, and Estradiol [E2] levels were approximately 150 picogram per milliliter [pg/mL] per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
1124055|NCT00505752|O4|Outcome|Follitropin Alfa 150 IU|Follitropin alfa (Gonal-f®) 150 IU administered subcutaneously once daily from S1 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
1124056|NCT00505752|O3|Outcome|AS900672-Enriched 150 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
1124057|NCT00505752|O2|Outcome|AS900672-Enriched 100 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
1124058|NCT00505752|O1|Outcome|AS900672-Enriched 50 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 50 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 150 international unit (IU) subcutaneously starting from Stimulation Day 6 (S6) up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of greater than or equal to [>=] 18 millimeter [mm], two or more additional follicles with a diameter of >= 16 mm, and Estradiol [E2] levels were approximately 150 picogram per milliliter [pg/mL] per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
1124059|NCT00505752|E4|Reported Event|Follitropin Alfa 150 IU|Follitropin alfa (Gonal-f®) 150 IU administered subcutaneously once daily from S1 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
1124156|NCT00505284|P1|Participant Flow|Placebo|
1124377|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
1124060|NCT00505752|E3|Reported Event|AS900672-Enriched 150 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
1124061|NCT00505752|E2|Reported Event|AS900672-Enriched 100 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
1124224|NCT00505076|B2|Baseline|MK-0777 3 mg BID|Subjects treated with MK-0777 GEM, 3 mg BID (twice daily)
1124062|NCT00505752|E1|Reported Event|AS900672-Enriched 50 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 50 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 150 international unit (IU) subcutaneously starting from Stimulation Day 6 (S6) up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of greater than or equal to [>=] 18 millimeter [mm], two or more additional follicles with a diameter of >= 16 mm, and Estradiol [E2] levels were approximately 150 picogram per milliliter [pg/mL] per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
1124063|NCT00505687|B1|Baseline|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
1124064|NCT00505687|P1|Participant Flow|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
1124065|NCT00505687|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
1124066|NCT00505687|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
1124067|NCT00505687|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
1124068|NCT00505687|E1|Reported Event|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
1124069|NCT00505661|B1|Baseline|Letrozole|2.5 mg by mouth (PO) daily
1124070|NCT00505661|P1|Participant Flow|Letrozole|2.5 mg by mouth (PO) daily
1124071|NCT00505661|O1|Outcome|Letrozole|2.5 mg by mouth (PO) daily
1124072|NCT00505661|E1|Reported Event|Letrozole|2.5 mg by mouth (PO) daily
1124073|NCT00505635|B1|Baseline|Biochemotherapy With Temozolomide|Temozolomide 250 mg/m^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m^2 IV Days 1-4; + Interleukin-2 9 MIU/m^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
1124074|NCT00505635|P1|Participant Flow|Biochemotherapy With Temozolomide|Temozolomide 250 mg/m^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m^2 IV Days 1-4; + Interleukin-2 9 MIU/m^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
1124075|NCT00505635|O1|Outcome|Biochemotherapy With Temozolomide|Temozolomide 250 mg/m^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m^2 IV Days 1-4; + Interleukin-2 9 MIU/m^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
1124076|NCT00505635|E1|Reported Event|Biochemotherapy With Temozolomide|Temozolomide 250 mg/m^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m^2 IV Days 1-4; + Interleukin-2 9 MIU/m^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
1124077|NCT00505622|B4|Baseline|Total|Total of all reporting groups
1124078|NCT00505622|B3|Baseline|Perampanel (Perampanel 4mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
1124079|NCT00505622|B2|Baseline|Perampanel (Entacapone 200mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
1124080|NCT00505622|B1|Baseline|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
1124081|NCT00505622|P3|Participant Flow|Perampanel (Perampanel 4mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
1124204|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
1124083|NCT00505622|P1|Participant Flow|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
1124084|NCT00505622|O3|Outcome|Perampanel (Perampanel 4mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
1124100|NCT00505518|P1|Participant Flow|Telepsychiatry Treatment|Patients in the telepsychiatry treatment group will videoconference the P.I. for regular psychiatric visits in addition to meeting with nursing home staff. Treatment suggestions will be provided to the patient's primary care physician to be implemented.
1124086|NCT00505622|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
1124087|NCT00505622|O3|Outcome|Perampanel (Perampanel 4mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
1124088|NCT00505622|O2|Outcome|Perampanel (Entacapone 200mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
1124089|NCT00505622|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
1124090|NCT00505622|O3|Outcome|Perampanel (Perampanel 4mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
1124091|NCT00505622|O2|Outcome|Perampanel (Entacapone 200mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
1124092|NCT00505622|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
1124093|NCT00505622|O3|Outcome|Perampanel (Perampanel 4mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
1124094|NCT00505622|O2|Outcome|Perampanel (Entacapone 200mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
1124095|NCT00505622|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
1124096|NCT00505622|E3|Reported Event|Perampanel (Perampanel 4mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
1124205|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
1124206|NCT00505284|O1|Outcome|Placebo|
1124097|NCT00505622|E2|Reported Event|Perampanel (Entacapone 200mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
1124098|NCT00505622|E1|Reported Event|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
1124099|NCT00505518|B1|Baseline|Telepsychiatry Treatment|Patients in the telepsychiatry treatment group will videoconference the P.I. for regular psychiatric visits in addition to meeting with nursing home staff. Treatment suggestions will be provided to the patient's primary care physician to be implemented.
1124101|NCT00505518|O1|Outcome|Telepsychiatry|Telepsychiatry-based follow up visits with psychiatrist.
1124104|NCT00505518|E1|Reported Event|Telepsychiatry Treatment|Patients in the telepsychiatry treatment group will videoconference the P.I. for regular psychiatric visits in addition to meeting with nursing home staff. Treatment suggestions will be provided to the patient's primary care physician to be implemented.
1124105|NCT00505414|B3|Baseline|Total|Total of all reporting groups
1124106|NCT00505414|B2|Baseline|Morphine (Titration Phase)|After signing informed consent eligible subjects were randomized to receive morphine controlled release. The oral medication was taken twice daily starting at 45 mg up to 90 mg twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
1124107|NCT00505414|B1|Baseline|Tapentadol (Titration Phase)|After signing informed consent eligible participants were randomized to receive tapentadol extended release. Oral tapentadol 100 mg to 250 mg twice daily. The oral medication was taken twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
1124108|NCT00505414|P5|Participant Flow|Morphine (Titration Phase)|After signing informed consent eligible participants were randomized to receive morphine controlled release. The oral medication was taken twice daily starting at 45 mg up to 90 mg twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
1124109|NCT00505414|P4|Participant Flow|Tapentadol (Titration Phase)|After signing informed consent eligible participants were randomized to receive tapentadol extended release. Oral tapentadol 100 mg up to 250 mg twice daily. The oral medication was taken twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
1124110|NCT00505414|P3|Participant Flow|Matching Placebo (Maintenance Phase)|Participants were re-randomized to placebo after being on tapentadol in the titration phase. At the start of this phase participants received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off of the tapentadol dose they had received in the titration period. From the fourth day of the maintenance period onwards they received placebo twice daily.
1124111|NCT00505414|P2|Participant Flow|Tapentadol (Maintenance Phase)|Participants re-randomized to tapentadol prolonged release in the maintenance phase continued on the dose level established at the end of the titration phase. Oral tapentadol 100 mg to 250 mg twice daily.
1124112|NCT00505414|P1|Participant Flow|Morphine (Maintenance Phase)|Participants in the maintenance phase continued on the dose level established in titration phase, i.e. 45 mg to 90 mg twice daily.
1124113|NCT00505414|O5|Outcome|Morphine (Titration Phase)|After signing informed consent eligible subjects were randomized to receive morphine controlled release. The oral medication was taken twice daily starting at 45 mg up to 90 mg twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
1124114|NCT00505414|O4|Outcome|Tapentadol (Titration Phase)|After signing informed consent eligible participants were randomized to receive tapentadol extended release. Oral tapentadol 100 mg to 250 mg twice daily. The oral medication was taken twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
1124115|NCT00505414|O3|Outcome|Matching Placebo (Maintenance Phase)|Participants were re-randomized to placebo after being on tapentadol in the titration phase. At the start of this phase participants received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off of the tapentadol dose they had received in the titration period. From the fourth day of the maintenance period onwards they received placebo twice daily.
1124116|NCT00505414|O2|Outcome|Tapentadol (Maintenance Phase)|Participants re-randomized to tapentadol prolonged release in the maintenance phase continued on the dose level established at the end of the titration phase. Oral tapentadol 100 mg to 250 mg twice daily.
1124117|NCT00505414|O1|Outcome|Morphine (Maintenance Phase)|Participants in the maintenance phase continued on the dose level established in titration phase, i.e. 45 mg to 90 mg twice daily.
1124118|NCT00505414|O3|Outcome|Matching Placebo (Maintenance Phase)|Participants were re-randomized to placebo after being on tapentadol in the titration phase. At the start of this phase participants received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off of the tapentadol dose they had received in the titration period. From the fourth day of the maintenance period onwards they received placebo twice daily.
1124119|NCT00505414|O2|Outcome|Tapentadol (Maintenance Phase)|Participants re-randomized to tapentadol prolonged release in the maintenance phase continued on the dose level established at the end of the titration phase. Oral tapentadol 100 mg to 250 mg twice daily.
1124120|NCT00505414|O1|Outcome|Morphine (Maintenance Phase)|Participants in the maintenance phase continued on the dose level established in titration phase, i.e. 45 mg to 90 mg twice daily.
1124256|NCT00504881|B1|Baseline|Placebo|Matching Placebo tablets administered twice a day
1124467|NCT00504231|P3|Participant Flow|60% Dose 0.3 mL ID|0.3 mL influenza vaccine delivered intradermally
1124121|NCT00505414|E5|Reported Event|Morphine (Titration Phase)|After signing informed consent eligible subjects were randomized to receive morphine controlled release. The oral medication was taken twice daily starting at 45 mg up to 90 mg twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
1124122|NCT00505414|E4|Reported Event|Tapentadol (Titration Phase)|After signing informed consent eligible participants were randomized to receive tapentadol extended release. Oral tapentadol 100 mg to 250 mg twice daily. The oral medication was taken twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
1124123|NCT00505414|E3|Reported Event|Matching Placebo (Maintenance Phase)|Participants were re-randomized to placebo after being on tapentadol in the titration phase. At the start of this phase participants received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off of the tapentadol dose they had received in the titration period. From the fourth day of the maintenance period onwards they received placebo twice daily.
1124124|NCT00505414|E2|Reported Event|Tapentadol (Maintenance Phase)|Participants re-randomized to tapentadol prolonged release in the maintenance phase continued on the dose level established at the end of the titration phase. Oral tapentadol 100 mg to 250 mg twice daily.
1124125|NCT00505414|E1|Reported Event|Morphine (Maintenance Phase)|Participants in the maintenance phase continued on the dose level established in titration phase, i.e. 45 mg to 90 mg twice daily.
1124126|NCT00505375|B3|Baseline|Total|Total of all reporting groups
1124127|NCT00505375|B2|Baseline|Placebo|"Intravenous infusions of placebo~Placebo: Intravenous infusions of placebo every other week for the first two doses and then every 28 days for a total of 27 doses"
1124169|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
1124128|NCT00505375|B1|Baseline|CTLA-4 Ig|"Intravenous infusions of CTLA-4 Ig~CTLA-4 Ig: Intravenous infusion of 10 mg/kg of CTLA-4 Ig every other week for the first two doses and then every 28 days for a total of 27 doses"
1124129|NCT00505375|P2|Participant Flow|Placebo|"Intravenous infusions of placebo~Placebo: Intravenous infusions of placebo every other week for the first two doses and then every 28 days for a total of 27 doses"
1124130|NCT00505375|P1|Participant Flow|CTLA-4 Ig|"Intravenous infusions of CTLA-4 Ig~CTLA-4 Ig: Intravenous infusion of 10 mg/kg of CTLA-4 Ig every other week for the first two doses and then every 28 days for a total of 27 doses"
1124131|NCT00505375|O2|Outcome|Placebo|Intravenous infusions of placebo every other week for the first two doses and then every 28 days for a total of 27 doses
1124132|NCT00505375|O1|Outcome|CTLA-4 Ig|Intravenous infusions 10 mg/kg of CTLA-4 Ig every other week for the first two doses and then every 28 days for a total of 27 doses
1124133|NCT00505375|E2|Reported Event|Placebo|"Intravenous infusions of placebo~Placebo: Intravenous infusions of placebo every other week for the first two doses and then every 28 days for a total of 27 doses"
1124134|NCT00505375|E1|Reported Event|CTLA-4 Ig|"Intravenous infusions of CTLA-4 Ig~CTLA-4 Ig: Intravenous infusion of 10 mg/kg of CTLA-4 Ig every other week for the first two doses and then every 28 days for a total of 27 doses"
1124135|NCT00505362|B3|Baseline|Total|Total of all reporting groups
1124136|NCT00505362|B2|Baseline|Rectus Muscle Non-closure|Two-layer uterine closure, peritoneal closure, fascial and skin closure, and rectus muscles non-closure.
1124137|NCT00505362|B1|Baseline|Rectus Muscle Closure|"Two-layer uterine closure, peritoneal closure, fascial and skin closure and reapproximation of the rectus muscles with three-interrupted sutures.~Rectus closure: Reapproximation of the rectus muscles with three-interrupted sutures"
1124138|NCT00505362|P2|Participant Flow|Rectus Muscle Non-closure|Two-layer uterine closure, peritoneal closure, fascial and skin closure, and rectus muscles non-closure.
1124139|NCT00505362|P1|Participant Flow|Rectus Muscle Closure|"Two-layer uterine closure, peritoneal closure, fascial and skin closure and reapproximation of the rectus muscles with three-interrupted sutures.~Rectus closure: Reapproximation of the rectus muscles with three-interrupted sutures"
1124140|NCT00505362|O2|Outcome|Rectus Muscle Non-closure|Two-layer uterine closure, peritoneal closure, fascial and skin closure, and rectus muscles non-closure.
1124141|NCT00505362|O1|Outcome|Rectus Muscle Closure|"Two-layer uterine closure, peritoneal closure, fascial and skin closure and reapproximation of the rectus muscles with three-interrupted sutures.~Rectus closure: Reapproximation of the rectus muscles with three-interrupted sutures"
1124142|NCT00505362|O2|Outcome|Rectus Muscle Non-closure|Two-layer uterine closure, peritoneal closure, fascial and skin closure, and rectus muscles non-closure.
1124143|NCT00505362|O1|Outcome|Rectus Muscle Closure|"Two-layer uterine closure, peritoneal closure, fascial and skin closure and reapproximation of the rectus muscles with three-interrupted sutures.~Rectus closure: Reapproximation of the rectus muscles with three-interrupted sutures"
1124144|NCT00505362|E2|Reported Event|Rectus Muscle Non-closure|Two-layer uterine closure, peritoneal closure, fascial and skin closure, and rectus muscles non-closure.
1124145|NCT00505362|E1|Reported Event|Rectus Muscle Closure|"Two-layer uterine closure, peritoneal closure, fascial and skin closure and reapproximation of the rectus muscles with three-interrupted sutures.~Rectus closure: Reapproximation of the rectus muscles with three-interrupted sutures"
1124146|NCT00505284|B6|Baseline|Total|Total of all reporting groups
1124147|NCT00505284|B5|Baseline|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
1124148|NCT00505284|B4|Baseline|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
1124149|NCT00505284|B3|Baseline|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
1124150|NCT00505284|B2|Baseline|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
1124151|NCT00505284|B1|Baseline|Placebo|
1124152|NCT00505284|P5|Participant Flow|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
1124153|NCT00505284|P4|Participant Flow|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
1124154|NCT00505284|P3|Participant Flow|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
1124155|NCT00505284|P2|Participant Flow|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
1124157|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
1124158|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
1124159|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
1124160|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
1124161|NCT00505284|O1|Outcome|Placebo|
1124162|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
1124163|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
1124164|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
1124165|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
1124166|NCT00505284|O1|Outcome|Placebo|
1124167|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
1124170|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
1124171|NCT00505284|O1|Outcome|Placebo|
1124172|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
1124173|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
1124174|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
1124175|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
1124176|NCT00505284|O1|Outcome|Placebo|
1124177|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
1124178|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
1124179|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
1124180|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
1124181|NCT00505284|O1|Outcome|Placebo|
1124182|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
1124183|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
1124184|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
1124185|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
1124186|NCT00505284|O1|Outcome|Placebo|
1124187|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
1124188|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
1124189|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
1124190|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
1124191|NCT00505284|O1|Outcome|Placebo|
1124192|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
1124193|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
1124194|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
1124195|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
1124196|NCT00505284|O1|Outcome|Placebo|
1124197|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
1124198|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
1124199|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
1124200|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
1124201|NCT00505284|O1|Outcome|Placebo|
1124202|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
1124203|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
1124592|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
1124207|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
1124208|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
1124209|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
1124210|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
1124211|NCT00505284|O1|Outcome|Placebo|
1124212|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
1124213|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
1124214|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
1124215|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
1124216|NCT00505284|O1|Outcome|Placebo|
1124217|NCT00505284|E5|Reported Event|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
1124218|NCT00505284|E4|Reported Event|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
1124219|NCT00505284|E3|Reported Event|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
1124220|NCT00505284|E2|Reported Event|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
1124225|NCT00505076|B1|Baseline|MK-077 8 mg BID|Subjects treated with MK-0777 GEM, 8 mg BID(twice daily)
1124226|NCT00505076|P3|Participant Flow|Placebo BID|Subjects treated with 2 tablets placebo BID (twice daily)
1124227|NCT00505076|P2|Participant Flow|MK-0777 3 mg BID|Subjects treated with MK-0777 GEM, 3 mg BID (twice daily)
1124228|NCT00505076|P1|Participant Flow|MK-0777 8 mg BID|Subjects treated with MK-0777 GEM, 8 mg BID(twice daily)
1124229|NCT00505076|O3|Outcome|Placebo BID|Subjects treated with placebo tablet BID
1124230|NCT00505076|O2|Outcome|MK-0777 3 mg BID|Subjects treated with MK-0777 , 3 mg BID
1124231|NCT00505076|O1|Outcome|MK-077 8 mg BID|Subjects treated with MK-0777, 8 mg BID
1124232|NCT00505076|O3|Outcome|Placebo BID|Subjects treated with placebo tablet BID
1124233|NCT00505076|O2|Outcome|MK-0777 3 mg BID|Subjects treated with MK-0777 , 3 mg BID
1124234|NCT00505076|O1|Outcome|MK-077 8 mg BID|Subjects treated with MK-0777, 8 mg BID
1124235|NCT00505076|O3|Outcome|Placebo BID|Subjects treated with placebo tablet BID
1124236|NCT00505076|O2|Outcome|MK-0777 3 mg BID|Subjects treated with MK-0777 , 3 mg BID
1124237|NCT00505076|O1|Outcome|MK-077 8 mg BID|Subjects treated with MK-0777, 8 mg BID
1124238|NCT00505076|E3|Reported Event|Placebo BID|Subjects treated with 2 tablets placebo BID (twice daily)
1124239|NCT00505076|E2|Reported Event|MK-0777 3 mg BID|Subjects treated with MK-0777 GEM, 3 mg BID (twice daily)
1124240|NCT00505076|E1|Reported Event|MK-077 8 mg BID|Subjects treated with MK-0777 GEM, 8 mg BID(twice daily)
1124241|NCT00504985|B1|Baseline|Fatigue in Emergency Center Patients|
1124242|NCT00504985|P1|Participant Flow|Fatigue in Emergency Center Patients|
1124243|NCT00504985|O1|Outcome|Fatigue in Emergency Center Patients|
1124244|NCT00504985|E1|Reported Event|Fatigue in Emergency Center Patients|
1124245|NCT00504894|B3|Baseline|Total|Total of all reporting groups
1124246|NCT00504894|B2|Baseline|Propofol|"Propofol give at 0.90 μgml−1 to gauge subject's responses to visual stimuli.~Propofol: A low dose of propofol 0.90 μgml−1, given intravenously while the subject is shown visually stimulating images in an MRI machine."
1124247|NCT00504894|B1|Baseline|Placebo|"Placebo given in low dose to gauge subject's responses to visual stimuli.~Placebo: A low dose given intravenously one time for just under an hour while the subject is shown visually stimulating images in an MRI machine."
1124248|NCT00504894|P2|Participant Flow|Propofol|"Propofol give at 0.90 μgml−1 to gauge subject's responses to visual stimuli.~Propofol: A low dose of propofol 0.90 μgml−1, given intravenously while the subject is shown visually stimulating images in an MRI machine."
1124249|NCT00504894|P1|Participant Flow|Placebo|"Placebo given in low dose to gauge subject's responses to visual stimuli.~Placebo: A low dose given intravenously one time for just under an hour while the subject is shown visually stimulating images in an MRI machine."
1124250|NCT00504894|O2|Outcome|Propofol|"Propofol give at 0.90 μgml−1 to gauge subject's responses to visual stimuli.~Propofol: A low dose of propofol 0.90 μgml−1, given intravenously while the subject is shown visually stimulating images in an MRI machine."
1124251|NCT00504894|O1|Outcome|Placebo|"Placebo given in low dose to gauge subject's responses to visual stimuli.~Placebo: A low dose given intravenously one time for just under an hour while the subject is shown visually stimulating images in an MRI machine."
1124252|NCT00504894|E2|Reported Event|Propofol|"Propofol give at 0.90 μgml−1 to gauge subject's responses to visual stimuli.~Propofol: A low dose of propofol 0.90 μgml−1, given intravenously while the subject is shown visually stimulating images in an MRI machine."
1124253|NCT00504894|E1|Reported Event|Placebo|"Placebo given in low dose to gauge subject's responses to visual stimuli.~Placebo: A low dose given intravenously one time for just under an hour while the subject is shown visually stimulating images in an MRI machine."
1124254|NCT00504881|B3|Baseline|Total Title|
1124255|NCT00504881|B2|Baseline|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
1124257|NCT00504881|P2|Participant Flow|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
1124258|NCT00504881|P1|Participant Flow|Placebo|Matching Placebo tablets administered twice a day
1124259|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
1124260|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1124261|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
1124262|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1124263|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
1124264|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1124265|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
1124266|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1124267|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
1124268|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1124269|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
1124270|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1124271|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
1124272|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1124450|NCT00504426|E3|Reported Event|OPC-249 (60IU)|60 IU of OPC-249/vial
1124273|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
1124274|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1124275|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
1124276|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1124277|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
1124278|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1124279|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
1124280|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1124281|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
1124282|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1124283|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
1124284|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1124285|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
1124286|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1124287|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
1124288|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1124289|NCT00504881|O2|Outcome|Brivaracetam|"A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day~Brivaracetam: Daily oral dose of two equal intakes, morning and evening, Brivaracetam 20 mg/day or Brivaracetam 50 mg/day or Brivaracetam 100 mg/day or Brivaracetam 150 mg/day, in a double-blinded way for the 16-week Treatment Period"
1124290|NCT00504881|O1|Outcome|Placebo|"Matching Placebo tablets administered twice a day~Placebo: Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 16-week Treatment Period"
1124291|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
1124292|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1124293|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
1124294|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1124295|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
1124296|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1124297|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
1124298|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1124299|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
1124300|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1124301|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
1124302|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1124303|NCT00504881|O2|Outcome|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
1124304|NCT00504881|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1124305|NCT00504881|E2|Reported Event|Brivaracetam|A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
1124306|NCT00504881|E1|Reported Event|Placebo|Matching Placebo tablets administered twice a day
1124307|NCT00504777|B1|Baseline|Rituximab + MTX|Participants received rituximab 1000 mg IV, and 100 mg methylprednisolone IV on Days 1 and 15. Participants were to be receiving background MTX (10-25 mg weekly, oral or parenteral dose).
1124308|NCT00504777|P1|Participant Flow|Rituximab + Methotrexate (MTX)|Participants received rituximab 1000 milligrams (mg) intravenously (IV) and 100 mg methylprednisolone IV on Days 1 and 15. Participants were to be receiving background MTX (10-25 mg weekly, oral or parenteral dose).
1124309|NCT00504777|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and 100 mg methylprednisolone IV on Days 1 and 15. Participants were to be receiving background MTX (10-25 mg weekly, oral or parenteral dose).
1124310|NCT00504777|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and 100 mg methylprednisolone IV on Days 1 and 15. Participants were to be receiving background MTX (10-25 mg weekly, oral or parenteral dose).
1124311|NCT00504777|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and 100 mg methylprednisolone IV on Days 1 and 15. Participants were to be receiving background MTX (10-25 mg weekly, oral or parenteral dose).
1124312|NCT00504777|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and 100 mg methylprednisolone IV on Days 1 and 15. Participants were to be receiving background MTX (10-25 mg weekly, oral or parenteral dose).
1124451|NCT00504426|E2|Reported Event|OPC-249 (30IU)|30 IU of OPC-249/vial
1124313|NCT00504777|E1|Reported Event|Rituximab + MTX|Participants received rituximab 1000 mg IV and 100 mg methylprednisolone IV on Days 1 and 15. Participants were to be receiving background MTX (10-25 mg weekly, oral or parenteral dose).
1124314|NCT00504751|B1|Baseline|Study Treatment|This is a single arm study
1124315|NCT00504751|P1|Participant Flow|Study Treatment|"This is a single arm study~bortezomib, dexamethasone, ifosfamide: VIPER chemotherapy will be administered every 28 days at the following doses:~Dexamethasone 40 mg IV days 1-4~Ifosfamide 1.0 gram/m2 CIVI over 24 hours days 1-4~Mesna 1.0 gram/m2 CIVI over 24 hours days 1-4 (mix solution with ifosfamide)~Cisplatin 25 mg IV days 1-4~Etoposide 100 mg/m2 CIVI over 24 hours days 1-4~Rituximab 500 mg/m2 IV day 1 prior to start of DICE (375 mg/m2 for subsequent cycles)~VELCADE 1.5 mg/m2 on days 2 and 5~mesna, cisplatin, etoposide, rituximab: VIPER chemotherapy will be administered every 28 days at the following doses:~Dexamethasone 40 mg IV days 1-4~Ifosfamide 1.0 gram/m2 CIVI over 24 hours days 1-4~Mesna 1.0 gram/m2 CIVI over 24 hours days 1-4 (mix solution with ifosfamide)~Cisplatin 25 mg IV days 1-4~Etoposide 100 mg/m2 CIVI over 24 hours days 1-4~Rituximab 500 mg/m2 IV day 1 prior to start of DICE (375 mg/m2 for subsequent cycles)~VELCADE 1.5"
1124316|NCT00504751|O1|Outcome|Study Treatment|This is a single arm study
1124317|NCT00504751|E1|Reported Event|Study Treatment|This is a single arm study
1124318|NCT00504725|B3|Baseline|Total|Total of all reporting groups
1124319|NCT00504725|B2|Baseline|Placebo|0.9 % saline bolus of equivalent volume
1124320|NCT00504725|B1|Baseline|Ketamine|Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
1124321|NCT00504725|P2|Participant Flow|Placebo|0.9 % saline bolus of equivalent volume
1124322|NCT00504725|P1|Participant Flow|Ketamine|Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
1124323|NCT00504725|O2|Outcome|Placebo|0.9 % saline bolus of equivalent volume
1124324|NCT00504725|O1|Outcome|Ketamine|Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
1124325|NCT00504725|O2|Outcome|Placebo|0.9 % saline bolus of equivalent volume
1124326|NCT00504725|O1|Outcome|Ketamine|Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
1124327|NCT00504725|O2|Outcome|Placebo|0.9 % saline bolus of equivalent volume
1124328|NCT00504725|O1|Outcome|Ketamine|Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
1124329|NCT00504725|E2|Reported Event|Placebo|0.9 % saline bolus of equivalent volume
1124330|NCT00504725|E1|Reported Event|Ketamine|Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
1124331|NCT00504660|B3|Baseline|Total|Total of all reporting groups
1124332|NCT00504660|B2|Baseline|Glioblastoma Multiforme|"6-TG 80 mg/m^2 PO every 6 Hours Day 1-3; Capecitabine 825 mg/m^2 PO every 12 hours Days 14-27 and Celebrex 400 mg PO every 12 hours Day 11-24; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR CCNU (Lomustine) 100 mg/m2 orally Day 4 of each 42-day cycle.~Participants receive Temozolomide if not had previous treatment and if had prior CCNU. Those previously treated with Temozolomide but not CCNU receive CCNU, and those that had Gliadel and Temozolomide with XRT receive Temozolomide."
1124333|NCT00504660|B1|Baseline|Anaplastic Tumors|6-TG 80 mg/m^2 orally (PO) every 6 hours Day 1-3; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR Lomustine 100 mg/m^2 PO on Day 4; Capecitabine 825 mg/m^2 every 12 hours; and Celebrex 400 mg PO every 12 hours for 13 days for 28 day course.
1124334|NCT00504660|P2|Participant Flow|Glioblastoma Multiforme|"6-TG 80 mg/m^2 PO every 6 Hours Day 1-3; Capecitabine 825 mg/m^2 PO every 12 hours Days 14-27 and Celebrex 400 mg PO every 12 hours Day 11-24; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR CCNU (Lomustine) 100 mg/m2 orally Day 4 of each 42-day cycle.~Participants receive Temozolomide if not had previous treatment and if had prior CCNU. Those previously treated with Temozolomide but not CCNU receive CCNU, and those that had Gliadel and Temozolomide with XRT receive Temozolomide."
1124335|NCT00504660|P1|Participant Flow|Anaplastic Tumors|6-TG 80 mg/m^2 orally (PO) every 6 hours Day 1-3; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR Lomustine 100 mg/m^2 PO on Day 4; Capecitabine 825 mg/m^2 every 12 hours; and Celebrex 400 mg PO every 12 hours for 13 days for 28 day course.
1124375|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
1124376|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
1124336|NCT00504660|O1|Outcome|Participants With Glioblastoma Multiforme|"6-TG 80 mg/m^2 PO every 6 Hours Day 1-3; Capecitabine 825 mg/m^2 PO every 12 hours Days 14-27 and Celebrex 400 mg PO every 12 hours Day 11-24; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR CCNU (Lomustine) 100 mg/m2 orally Day 4 of each 42-day cycle.~Participants receive Temozolomide if not had previous treatment and if had prior CCNU. Those previously treated with Temozolomide but not CCNU receive CCNU, and those that had Gliadel and Temozolomide with XRT receive Temozolomide."
1124337|NCT00504660|O1|Outcome|Participants With Recurrent Anaplastic Glioma|6-TG 80 mg/m^2 orally (PO) every 6 hours Day 1-3; Capecitabine 825 mg/m^2 and Celebrex 400 mg PO every 12 hours; Arm 1 Temozolomide (TMZ) 150 mg/m^2 PO daily Days 4-8 OR Arm 2 Lomustine 100 mg/m^2 PO on Day 4; Arm 2 Participants if previously received Temozolomide but not Lomustine (CCNU) receive Lomustine; or if had Gliadel wafers and Temozolomide with radiotherapy (XRT) receive Temozolomide.
1124338|NCT00504660|E2|Reported Event|Glioblastoma Multiforme|"6-TG 80 mg/m^2 PO every 6 Hours Day 1-3; Capecitabine 825 mg/m^2 PO every 12 hours Days 14-27 and Celebrex 400 mg PO every 12 hours Day 11-24; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR CCNU (Lomustine) 100 mg/m2 orally Day 4 of each 42-day cycle.~Participants receive Temozolomide if not had previous treatment and if had prior CCNU. Those previously treated with Temozolomide but not CCNU receive CCNU, and those that had Gliadel and Temozolomide with XRT receive Temozolomide."
1124339|NCT00504660|E1|Reported Event|Anaplastic Tumors|6-TG 80 mg/m^2 orally (PO) every 6 hours Day 1-3; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR Lomustine 100 mg/m^2 PO on Day 4; Capecitabine 825 mg/m^2 every 12 hours; and Celebrex 400 mg PO every 12 hours for 13 days for 28 day course.
1124340|NCT00504595|B5|Baseline|Total|Total of all reporting groups
1124341|NCT00504595|B4|Baseline|Placebo Comparator: Healthy Volunteers|Healthy Volunteers who received placebo Intravenous (IV) at Day 1.
1124342|NCT00504595|B3|Baseline|Placebo Comparator: RA Patients|Rheumatoid Arthritis patients who received placebo Intravenous (IV) on Day 1, Day 15 and Day 43.
1124343|NCT00504595|B2|Baseline|ACZ885 (Canakinumab) : Healthy Volunteers|Healthy Volunteers taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1
1124452|NCT00504426|E1|Reported Event|Placebo|Placebo of OPC-249/vial
1124344|NCT00504595|B1|Baseline|ACZ885 (Canakinumab) : RA Patients|Patients with Rheumatoid Arthritis RA taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1, Day 15, and Day 43.
1124345|NCT00504595|P4|Participant Flow|Placebo Comparator: Healthy Volunteers|Healthy Volunteers who received placebo Intravenous (IV) at Day 1.
1124346|NCT00504595|P3|Participant Flow|Placebo Comparator: RA Patients|Rheumatoid Arthritis patients who received placebo Intravenous (IV) on Day 1, Day 15 and Day 43.
1124347|NCT00504595|P2|Participant Flow|ACZ885 (Canakinumab) : Healthy Volunteers|Healthy Volunteers taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1
1124348|NCT00504595|P1|Participant Flow|ACZ885 (Canakinumab) : RA Patients|Patients with Rheumatoid Arthritis RA taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1, Day 15, and Day 43.
1124349|NCT00504595|O2|Outcome|Placebo Comparator: RA Patients|Rheumatoid Arthritis patients who received placebo Intravenous (IV) on Day 1, Day 15 and Day 43.
1124350|NCT00504595|O1|Outcome|ACZ885 (Canakinumab) : RA Patients|Patients with Rheumatoid Arthritis RA taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1, Day 15, and Day 43.
1124351|NCT00504595|O2|Outcome|Placebo Comparator: RA Patients|Patients with Rheumatoid Arthritis (RA) who received placebo Intravenous (IV) on Day 1, Day 15 and Day 43.
1124352|NCT00504595|O1|Outcome|ACZ885 (Canakinumab): RA Patients|Patients with Rheumatoid Arthritis (RA) taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1, Day 15, and Day 43.
1124353|NCT00504595|O2|Outcome|Placebo Comparator: RA Patients|Rheumatoid Arthritis patients who received placebo Intravenous (IV) on Day 1, Day 15 and Day 43.
1124354|NCT00504595|O1|Outcome|ACZ885 (Canakinumab) : RA Patients|Patients with Rheumatoid Arthritis RA taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1, Day 15, and Day 43.
1124355|NCT00504595|E4|Reported Event|Placebo Comparator: RA Patients|Rheumatoid Arthritis patients who received placebo Intravenous (IV) on Day 1, Day 15 and Day 43.
1124356|NCT00504595|E3|Reported Event|ACZ885 (Canakinumab): RA Patients|Patients with Rheumatoid Arthritis RA taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1, Day 15, and Day 43.
1124357|NCT00504595|E2|Reported Event|Placebo Comparator: Healthy Volunteers|Healthy Volunteers who received placebo Intravenous (IV) at Day 1.
1124358|NCT00504595|E1|Reported Event|ACZ885 (Canakinumab): Healthy Volunteers|Healthy Volunteers taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1.
1124359|NCT00504556|B6|Baseline|Total|Total of all reporting groups
1124360|NCT00504556|B5|Baseline|Warfarin Tablets|"warfarin tablets~warfarin: warfarin tablets"
1124361|NCT00504556|B4|Baseline|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
1124362|NCT00504556|B3|Baseline|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
1124363|NCT00504556|B2|Baseline|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
1124364|NCT00504556|B1|Baseline|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
1124365|NCT00504556|P5|Participant Flow|Warfarin Tablets|"warfarin tablets~warfarin: warfarin tablets"
1124366|NCT00504556|P4|Participant Flow|DU-176b 60mg Bid|"DU-176b 60mg tablets two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
1124367|NCT00504556|P3|Participant Flow|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
1124368|NCT00504556|P2|Participant Flow|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
1124369|NCT00504556|P1|Participant Flow|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
1124370|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
1124371|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
1124372|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
1124373|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
1124374|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
1125859|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
1124378|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
1124379|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
1124380|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
1124381|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
1124382|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
1124383|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
1124384|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
1124385|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
1124386|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
1124387|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
1124388|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
1124389|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
1124390|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
1124391|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
1124392|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
1124393|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
1124394|NCT00504556|O5|Outcome|Warfarin Tablets|"warfarin tablets~warfarin: warfarin tablets"
1124395|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
1124396|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
1124397|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
1124398|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
1124399|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
1124400|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
1124401|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
1124402|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
1124403|NCT00504556|O5|Outcome|Warfarin Tablets|"warfarin tablets~warfarin: warfarin tablets"
1124404|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
1124405|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
1124406|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
1124407|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
1124408|NCT00504556|O5|Outcome|Warfarin Tablets|"warfarin tablets~warfarin: warfarin tablets"
1124409|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
1124410|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
1124411|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
1124412|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
1124413|NCT00504556|O5|Outcome|Warfarin Tablets|"warfarin tablets~warfarin: warfarin tablets"
1124414|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
1124415|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
1124416|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
1124417|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
1124418|NCT00504556|O5|Outcome|Warfarin Tablets|"warfarin tablets~warfarin: warfarin tablets"
1124419|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
1124420|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
1124421|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
1124422|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
1124423|NCT00504556|E5|Reported Event|Warfarin Tablets|"warfarin tablets~warfarin: warfarin tablets"
1124424|NCT00504556|E4|Reported Event|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
1124425|NCT00504556|E3|Reported Event|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
1124426|NCT00504556|E2|Reported Event|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
1124427|NCT00504556|E1|Reported Event|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
1124428|NCT00504504|B1|Baseline|Rituximab + ABVD Chemotherapy|Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
1124429|NCT00504504|P1|Participant Flow|Rituximab + ABVD Chemotherapy|Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
1124430|NCT00504504|O1|Outcome|Rituximab + ABVD Chemotherapy|Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
1124431|NCT00504504|E1|Reported Event|Rituximab + ABVD Chemotherapy|Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
1124432|NCT00504426|B5|Baseline|Total|Total of all reporting groups
1124433|NCT00504426|B4|Baseline|OPC-249 (120IU)|120 IU of OPC-249/vial
1124434|NCT00504426|B3|Baseline|OPC-249 (60IU)|60 IU of OPC-249/vial
1124435|NCT00504426|B2|Baseline|OPC-249 (30IU)|30 IU of OPC-249/vial
1124436|NCT00504426|B1|Baseline|Placebo|Placebo of OPC-249/vial
1124437|NCT00504426|P4|Participant Flow|OPC-249 (120IU)|120 IU of OPC-249/vial
1124438|NCT00504426|P3|Participant Flow|OPC-249 (60IU)|60 IU of OPC-249/vial
1124439|NCT00504426|P2|Participant Flow|OPC-249 (30IU)|30 IU of OPC-249/vial
1124440|NCT00504426|P1|Participant Flow|Placebo|Placebo of OPC-249/vial
1124441|NCT00504426|O4|Outcome|OPC-249 (120IU)|120 IU of OPC-249/vial
1124442|NCT00504426|O3|Outcome|OPC-249 (60IU)|60 IU of OPC-249/vial
1124443|NCT00504426|O2|Outcome|OPC-249 (30IU)|30 IU of OPC-249/vial
1124444|NCT00504426|O1|Outcome|Placebo|Placebo of OPC-249/vial
1124445|NCT00504426|O4|Outcome|OPC-249 (120IU)|120 IU of OPC-249 /vial
1124446|NCT00504426|O3|Outcome|OPC-249 (60IU)|60 IU of OPC-249 /vial
1124447|NCT00504426|O2|Outcome|OPC-249 (30IU)|30 IU of OPC-249 /vial
1124448|NCT00504426|O1|Outcome|Placebo|Placebo of OPC-249/vial
1124449|NCT00504426|E4|Reported Event|OPC-249 (120IU)|120 IU of OPC-249/vial
1124453|NCT00504257|B1|Baseline|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
1124454|NCT00504257|P1|Participant Flow|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
1124455|NCT00504257|O1|Outcome|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
1124456|NCT00504257|O1|Outcome|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
1124457|NCT00504257|O1|Outcome|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
1124458|NCT00504257|O1|Outcome|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
1124459|NCT00504257|O1|Outcome|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
1124460|NCT00504257|E1|Reported Event|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
1124461|NCT00504231|B5|Baseline|Total|Total of all reporting groups
1124462|NCT00504231|B4|Baseline|60% Dose 0.15 mL x 2 ID|0.15 mL influenza vaccine twice delivered intradermally with needle and syringe
1124463|NCT00504231|B3|Baseline|60% Dose 0.3 mL ID|0.3 mL influenza vaccine delivered intradermally
1124464|NCT00504231|B2|Baseline|60% Dose 0.3 mL IM|0.3 mL influenza vaccine delivered intramuscularly with needle/syringe
1124465|NCT00504231|B1|Baseline|Full-dose 0.5 mL IM|0.5 mL influenza vaccine delivered intramuscularly with needle/syringe
1124466|NCT00504231|P4|Participant Flow|60% Dose 0.15 mL x 2 ID|0.15 mL influenza vaccine twice delivered intradermally with needle and syringe
1125860|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
1124468|NCT00504231|P2|Participant Flow|60% Dose 0.3 mL IM|0.3 mL influenza vaccine delivered intramuscularly with needle/syringe
1124469|NCT00504231|P1|Participant Flow|Full-dose 0.5 mL IM|0.5 mL influenza vaccine delivered intramuscularly with needle/syringe
1124470|NCT00504231|O4|Outcome|60% Dose 0.15 mL x 2 ID|0.15 mL influenza vaccine twice delivered intradermally with needle and syringe
1124471|NCT00504231|O3|Outcome|60% Dose 0.3 mL ID|0.3 mL influenza vaccine delivered intradermally
1124472|NCT00504231|O2|Outcome|60% Dose 0.3 mL IM|0.3 mL influenza vaccine delivered intramuscularly with needle/syringe
1124473|NCT00504231|O1|Outcome|Full-dose 0.5 mL IM|0.5 mL influenza vaccine delivered intramuscularly with needle/syringe
1124474|NCT00504231|O4|Outcome|60% Dose 0.15 mL x 2 ID|60% dose - 0.15 mL delivered twice intradermally with needle and syringe
1124475|NCT00504231|O3|Outcome|60% Dose 0.3 mL ID|60% dose - 0.3 mL delivered intradermally with needle and syringe
1124476|NCT00504231|O2|Outcome|60% Dose 0.3 mL IM|60% dose - 0.3 mL delivered intramuscularly with needle and syringe
1124477|NCT00504231|O1|Outcome|Full-dose 0.5 mL IM|100% dose - 0.5mL delivered intramuscularly with needle and syringe
1124478|NCT00504231|O4|Outcome|60% Dose 0.15 mL x 2 ID|60% dose - 0.15 mL delivered twice intradermally with needle and syringe
1124479|NCT00504231|O3|Outcome|60% Dose 0.3 mL ID|60% dose - 0.3 mL delivered intradermally with needle and syringe
1124480|NCT00504231|O2|Outcome|60% Dose 0.3 mL IM|60% dose - 0.3 mL delivered intramuscularly with needle and syringe
1124481|NCT00504231|O1|Outcome|Full-dose 0.5 mL IM|100% dose - 0.5mL delivered intramuscularly with needle and syringe
1124482|NCT00504231|E4|Reported Event|60% Dose 0.15 mL x 2 ID|0.15 mL influenza vaccine twice delivered intradermally with needle and syringe
1124483|NCT00504231|E3|Reported Event|60% Dose 0.3 mL ID|0.3 mL influenza vaccine delivered intradermally
1124484|NCT00504231|E2|Reported Event|60% Dose 0.3 mL IM|0.3 mL influenza vaccine delivered intramuscularly with needle/syringe
1124485|NCT00504231|E1|Reported Event|Full-dose 0.5 mL IM|0.5 mL influenza vaccine delivered intramuscularly with needle/syringe
1124486|NCT00504166|B3|Baseline|Total|Total of all reporting groups
1124488|NCT00504166|B1|Baseline|Alendronate Sodium|alendronate sodium 70 mg tablet once a week for 24 months
1124489|NCT00504166|P2|Participant Flow|Placebo|placebo to match alendronate sodium
1124490|NCT00504166|P1|Participant Flow|Alendronate Sodium|alendronate sodium 70 mg tablet once a week for 24 months
1124491|NCT00504166|O2|Outcome|Placebo Treatment|daily 2800 IU of vitamin D3 and OSCal + D (1000 mg of calcium + 400 IU of vitamin D3)
1124492|NCT00504166|O1|Outcome|Alendronate Treatment|70 mg of alendronate once weekly and daily 2800 IU of vitamin D3 and OSCal + D (1000 mg of calcium + 400 IU of vitamin D3)
1124493|NCT00504166|E2|Reported Event|Placebo|placebo to match alendronate sodium
1124494|NCT00504166|E1|Reported Event|Alendronate Sodium|alendronate sodium 70 mg tablet once a week for 24 months
1124495|NCT00504153|B1|Baseline|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1124496|NCT00504153|P1|Participant Flow|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1124497|NCT00504153|O1|Outcome|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1124498|NCT00504153|O1|Outcome|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1124499|NCT00504153|O1|Outcome|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1124500|NCT00504153|O1|Outcome|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1124501|NCT00504153|O1|Outcome|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1124502|NCT00504153|E1|Reported Event|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1124503|NCT00504075|B1|Baseline|GAMMAPLEX|The first course of GAMMAPLEX was administered as an intravenous infusion of 1g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen was administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
1124504|NCT00504075|P1|Participant Flow|GAMMAPLEX|The first course of GAMMAPLEX was administered as an intravenous infusion of 1g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen was administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
1124505|NCT00504075|O1|Outcome|GAMMAPLEX|The first course of GAMMAPLEX was administered as an intravenous infusion of 1g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen was administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
1124506|NCT00504075|O1|Outcome|GAMMAPLEX|The first course of Gammaplex was administered as an intravenous infusion of 1g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen was administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
1124507|NCT00504075|O1|Outcome|GAMMAPLEX|The first course of GAMMAPLEX was administered as an intravenous infusion of 1g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen was administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
1124508|NCT00504075|E1|Reported Event|GAMMAPLEX|The first course of GAMMAPLEX was administered as an intravenous infusion of 1g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen was administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
1137283|NCT00467844|E3|Reported Event|3 mg of Placebo|Placebo
1124509|NCT00503906|B1|Baseline|Abraxane, Avastin and Gemcitabine|"Each treatment cycle is 28 days. Participants will be treated until disease progression:~Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Avastin: 10 mg/kg IV on days 1 and 15 of each cycle."
1124510|NCT00503906|P1|Participant Flow|Abraxane, Avastin and Gemcitabine|"Each treatment cycle is 28 days. Participants will be treated until disease progression:~Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Avastin: 10 mg/kg IV on days 1 and 15 of each cycle."
1124511|NCT00503906|O1|Outcome|Abraxane, Avastin and Gemcitabine|"Each treatment cycle is 28 days. Participants will be treated until disease progression:~Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Avastin: 10 mg/kg IV on days 1 and 15 of each cycle."
1124512|NCT00503906|O1|Outcome|Abraxane, Avastin and Gemcitabine|"Each treatment cycle is 28 days. Participants will be treated until disease progression:~Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Avastin: 10 mg/kg IV on days 1 and 15 of each cycle.~Avastin~Gemcitabine~Abraxane"
1124513|NCT00503906|O1|Outcome|Abraxane, Avastin and Gemcitabine|"Each treatment cycle is 28 days. Participants will be treated until disease progression:~Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Avastin: 10 mg/kg IV on days 1 and 15 of each cycle."
1124543|NCT00503776|E4|Reported Event|Arm IIB|Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
1124544|NCT00503776|E3|Reported Event|Arm IIA|Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
1124514|NCT00503906|O1|Outcome|Abraxane, Avastin and Gemcitabine|"Each treatment cycle is 28 days. Participants will be treated until disease progression:~Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Avastin: 10 mg/kg IV on days 1 and 15 of each cycle."
1124515|NCT00503906|O1|Outcome|Abraxane, Avastin and Gemcitabine|"Each treatment cycle is 28 days. Participants will be treated until disease progression:~Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Avastin: 10 mg/kg IV on days 1 and 15 of each cycle."
1124516|NCT00503906|O1|Outcome|Abraxane, Avastin and Gemcitabine|"Each treatment cycle is 28 days. Participants will be treated until disease progression:~Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Avastin: 10 mg/kg IV on days 1 and 15 of each cycle."
1124517|NCT00503906|E1|Reported Event|Abraxane, Avastin and Gemcitabine|"Each treatment cycle is 28 days. Participants will be treated until disease progression:~Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;~Avastin: 10 mg/kg IV on days 1 and 15 of each cycle."
1124518|NCT00503841|B1|Baseline|Erlotinib Hydrochloride|If participants would have went onto study they would receive erlotinib hydrochloride PO (orally) QD (every day) on days -14-0 immediately prior to scheduled surgery. Treatment continues in the absence of disease progression or unacceptable toxicity.
1124519|NCT00503841|P1|Participant Flow|Erlotinib Hydrochloride|"If participants would have went onto study they would receive erlotinib(Tarceva®)hydrochloride 150 mg/day starting dose PO (orally) self-administered, QD (every day) on days -14 until day 0 immediately prior to scheduled surgery, Tissue sent for biomarker modulation analysis~Treatment continues in the absence of disease progression or unacceptable toxicity.~Biomarker analysis performed, toxicity monitored for 7 days following last dose of erlotinib (Tarceva®)"
1124520|NCT00503841|O1|Outcome|Erlotinib Hydrochloride|Patients must be willing to consider treatment with erlotinib, in the event they are eligible for the treatment phase of the study. Erlotinib (Tarceva®) will be self-administered in an open-label, unblinded manner to all patients enrolled in the study. During the treatment period, patients will receive single-agent erlotinib (Tarceva®), at a dose of 150 mg/day mg by mouth. Patients will be instructed to take tablets once daily. The day of planned surgical resection of the invasive breast cancer will be considered day 0. Patients will undergo baseline physical examination and performance status evaluation on or before day -14. Patients will begin treatment with erlotinib 150 mg (1 tablet) orally daily on day -14 and it will be continued for a total of 15 days, through day 0.
1124521|NCT00503841|E1|Reported Event|Erlotinib Hydrochloride|Patients will be instructed to take tablets once daily.Patients will begin treatment with erlotinib 150 mg (1 tablet) orally daily on day -14 and it will be continued for a total of 15 days, through day 0.The day of planned surgical resection of the invasive breast cancer will be considered day 0.
1124522|NCT00503776|B5|Baseline|Total|Total of all reporting groups
1124523|NCT00503776|B4|Baseline|Arm IIB|Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
1124524|NCT00503776|B3|Baseline|Arm IIA|Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
1124525|NCT00503776|B2|Baseline|Arm IB|Patients undergo SNT and low weight resistance training (LWRT).
1124526|NCT00503776|B1|Baseline|Arm IA|Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
1124527|NCT00503776|P4|Participant Flow|Arm IIB|Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
1124528|NCT00503776|P3|Participant Flow|Arm IIA|Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
1124529|NCT00503776|P2|Participant Flow|Arm IB|Patients undergo SNT and low weight resistance training (LWRT).
1124593|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
1124530|NCT00503776|P1|Participant Flow|Arm IA|Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
1124531|NCT00503776|O4|Outcome|Arm IIB|Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
1124532|NCT00503776|O3|Outcome|Arm IIA|Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
1124533|NCT00503776|O2|Outcome|Arm IB|Patients undergo SNT and low weight resistance training (LWRT).
1124534|NCT00503776|O1|Outcome|Arm IA|Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
1124535|NCT00503776|O4|Outcome|Arm IIB|Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
1124536|NCT00503776|O3|Outcome|Arm IIA|Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
1124537|NCT00503776|O2|Outcome|Arm IB|Patients undergo SNT and low weight resistance training (LWRT).
1124538|NCT00503776|O1|Outcome|Arm IA|Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
1124539|NCT00503776|O4|Outcome|Arm IIB|Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
1124540|NCT00503776|O3|Outcome|Arm IIA|Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
1124541|NCT00503776|O2|Outcome|Arm IB|Patients undergo SNT and low-weight resistance training (LWRT).
1124542|NCT00503776|O1|Outcome|Arm IA|Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
1124545|NCT00503776|E2|Reported Event|Arm IB|Patients undergo SNT and low weight resistance training (LWRT).
1124546|NCT00503776|E1|Reported Event|Arm IA|Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
1124547|NCT00503750|B1|Baseline|Trastuzumab and Abraxane Followed Trastuzumab and Vinorelbine|Patients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). Growth factor support with pegfilgrastim (Neulasta®) is required 24 to 48 hours following completion of each cycle of ABI-007. Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52.
1124548|NCT00503750|P1|Participant Flow|Trastuzumab and Abraxane Followed Trastuzumab and Vinorelbine|Patients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). Growth factor support with pegfilgrastim (Neulasta®) is required 24 to 48 hours following completion of each cycle of ABI-007. Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52.
1124549|NCT00503750|O1|Outcome|Trastuzumab and Abraxane Followed Trastuzumab and Vinorelbine|Patients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). Growth factor support with pegfilgrastim (Neulasta®) is required 24 to 48 hours following completion of each cycle of ABI-007. Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52.
1124550|NCT00503750|O1|Outcome|Trastuzumab and Abraxane Followed Trastuzumab and Vinorelbine|Patients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). Growth factor support with pegfilgrastim (Neulasta®) is required 24 to 48 hours following completion of each cycle of ABI-007. Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52.
1124594|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
1124595|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
1124596|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
1124597|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
1124598|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
1124551|NCT00503750|E1|Reported Event|Trastuzumab and Abraxane Followed Trastuzumab and Vinorelbine|Patients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). Growth factor support with pegfilgrastim (Neulasta®) is required 24 to 48 hours following completion of each cycle of ABI-007. Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52.
1124552|NCT00503698|B3|Baseline|Total|Total of all reporting groups
1124553|NCT00503698|B2|Baseline|Placebo|Placebo once daily, week 0 to end of trial
1124554|NCT00503698|B1|Baseline|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
1124555|NCT00503698|P2|Participant Flow|Placebo|Placebo once daily, week 0 to end of trial
1124556|NCT00503698|P1|Participant Flow|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
1124557|NCT00503698|O2|Outcome|Placebo|Placebo once daily, week 0 to end of trial
1124558|NCT00503698|O1|Outcome|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
1124559|NCT00503698|O2|Outcome|Placebo|Placebo once daily, week 0 to end of trial
1124560|NCT00503698|O1|Outcome|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
1124561|NCT00503698|O2|Outcome|Placebo|Placebo once daily, week 0 to end of trial
1124562|NCT00503698|O1|Outcome|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
1124563|NCT00503698|O2|Outcome|Placebo|Placebo once daily, week 0 to end of trial
1124564|NCT00503698|O1|Outcome|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
1124565|NCT00503698|O2|Outcome|Placebo|Placebo once daily, week 0 to end of trial
1124566|NCT00503698|O1|Outcome|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
1133730|NCT00477269|O2|Outcome|Placebo|Placebo
1124567|NCT00503698|E2|Reported Event|Placebo|Placebo once daily, week 0 to end of trial
1124568|NCT00503698|E1|Reported Event|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
1124569|NCT00503425|B1|Baseline|Rituximab|Participants received rituximab (MabThera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
1124570|NCT00503425|P1|Participant Flow|Rituximab|Participants received rituximab (MabThera) 1000 milligrams (mg) intravenous (IV) dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the European League Against Rheumatism (EULAR) response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
1124571|NCT00503425|O1|Outcome|Rituximab|Participants received rituximab (Mabthera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
1124572|NCT00503425|O1|Outcome|Rituximab|Participants received rituximab (MabThera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
1124573|NCT00503425|O1|Outcome|Rituximab|Participants received rituximab (MabThera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
1124574|NCT00503425|O1|Outcome|Rituximab|Participants received rituximab (MabThera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
1124575|NCT00503425|O1|Outcome|Rituximab|Participants received rituximab (MabThera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
1124576|NCT00503425|E1|Reported Event|Rituximab|Participants received rituximab (Mabthera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
1124577|NCT00503399|B3|Baseline|Total|Total of all reporting groups
1124578|NCT00503399|B2|Baseline|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
1124579|NCT00503399|B1|Baseline|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
1124580|NCT00503399|P2|Participant Flow|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
1124581|NCT00503399|P1|Participant Flow|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
1124582|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
1124583|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
1124584|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
1124585|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
1124586|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
1124587|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
1124588|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
1124589|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
1124590|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
1124591|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
1137284|NCT00467844|E2|Reported Event|GTx-024|3 mg
1124599|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
1124600|NCT00503399|E2|Reported Event|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
1124601|NCT00503399|E1|Reported Event|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
1124602|NCT00503308|B3|Baseline|Total|Total of all reporting groups
1124603|NCT00503308|B2|Baseline|Abbreviated Consenting Intervention|The intervention arm used a 2-sentence script which lasted approximately 30 seconds.
1124604|NCT00503308|B1|Baseline|Standard Consenting Intervention|The standardized HIV pre-test counseling and consent process took approximately 2–5 minutes and reviewed the definition of HIV, modes of transmission and prevention, interpretation of test results and the benefits of testing.
1124605|NCT00503308|P2|Participant Flow|Abbreviated Consenting Intervention|The intervention arm used a 2-sentence script which lasted approximately 30 seconds.
1124606|NCT00503308|P1|Participant Flow|Standard Consenting Intervention|The standardized HIV pre-test counseling and consent process took approximately 2–5 minutes and reviewed the definition of HIV, modes of transmission and prevention, interpretation of test results and the benefits of testing.
1124607|NCT00503308|O2|Outcome|Abbreviated Consenting Intervention|The intervention arm used a 2-sentence script which lasted approximately 30 seconds.
1124608|NCT00503308|O1|Outcome|Standard Consenting Intervention|The standardized HIV pre-test counseling and consent process took approximately 2–5 minutes and reviewed the definition of HIV, modes of transmission and prevention, interpretation of test results and the benefits of testing.
1124609|NCT00503308|E2|Reported Event|Abbreviated Consenting Intervention|The intervention arm used a 2-sentence script which lasted approximately 30 seconds.
1124610|NCT00503308|E1|Reported Event|Standard Consenting Intervention|The standardized HIV pre-test counseling and consent process took approximately 2–5 minutes and reviewed the definition of HIV, modes of transmission and prevention, interpretation of test results and the benefits of testing.
1124652|NCT00503113|O1|Outcome|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
1124611|NCT00503139|B1|Baseline|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
1124612|NCT00503139|P1|Participant Flow|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
1124613|NCT00503139|O1|Outcome|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
1124614|NCT00503139|O1|Outcome|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
1124615|NCT00503139|O1|Outcome|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
1124616|NCT00503139|O1|Outcome|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
1124617|NCT00503139|O1|Outcome|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
1124618|NCT00503139|O1|Outcome|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
1124619|NCT00503139|O1|Outcome|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
1124620|NCT00503139|O1|Outcome|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
1124621|NCT00503139|E1|Reported Event|Etanercept (Genetical Recombination)|Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
1124622|NCT00503113|B4|Baseline|Total|Total of all reporting groups
1124623|NCT00503113|B3|Baseline|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
1124624|NCT00503113|B2|Baseline|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
1124625|NCT00503113|B1|Baseline|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
1124626|NCT00503113|P3|Participant Flow|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
1124627|NCT00503113|P2|Participant Flow|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
1124628|NCT00503113|P1|Participant Flow|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
1124629|NCT00503113|O3|Outcome|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
1124630|NCT00503113|O2|Outcome|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
1124631|NCT00503113|O1|Outcome|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
1124632|NCT00503113|O3|Outcome|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
1124633|NCT00503113|O2|Outcome|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
1124634|NCT00503113|O1|Outcome|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
1124635|NCT00503113|O3|Outcome|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
1124636|NCT00503113|O2|Outcome|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
1124637|NCT00503113|O1|Outcome|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
1124638|NCT00503113|O3|Outcome|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
1124639|NCT00503113|O2|Outcome|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
1124640|NCT00503113|O1|Outcome|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
1124641|NCT00503113|O3|Outcome|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
1124642|NCT00503113|O2|Outcome|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
1124643|NCT00503113|O1|Outcome|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
1124644|NCT00503113|O3|Outcome|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
1124645|NCT00503113|O2|Outcome|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
1124646|NCT00503113|O1|Outcome|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
1124647|NCT00503113|O3|Outcome|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
1124648|NCT00503113|O2|Outcome|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
1124649|NCT00503113|O1|Outcome|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
1124650|NCT00503113|O3|Outcome|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
1124651|NCT00503113|O2|Outcome|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
1133731|NCT00477269|O1|Outcome|STI571|STI571
1124653|NCT00503113|E3|Reported Event|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
1124654|NCT00503113|E2|Reported Event|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
1124655|NCT00503113|E1|Reported Event|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
1124656|NCT00503009|B4|Baseline|Total|Total of all reporting groups
1124657|NCT00503009|B3|Baseline|Placebo Diskus BID|Placebo twice daily
1124658|NCT00503009|B2|Baseline|FP 250 mcg BID|Fluticasone Propionate (FP) (250 microgram) twice daily
1124659|NCT00503009|B1|Baseline|FSC 250/50 mcg BID|Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
1124660|NCT00503009|P3|Participant Flow|Placebo Diskus BID|Placebo twice daily
1124661|NCT00503009|P2|Participant Flow|FP 250 mcg BID|Fluticasone Propionate (FP) (250 microgram) twice daily
1124662|NCT00503009|P1|Participant Flow|FSC 250/50 mcg BID|Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
1124663|NCT00503009|O3|Outcome|Placebo Diskus BID|Placebo twice daily
1124664|NCT00503009|O2|Outcome|FP 250 mcg BID|Fluticasone Propionate (FP) (250 microgram) twice daily
1124665|NCT00503009|O1|Outcome|FSC 250/50 mcg BID|Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
1124666|NCT00503009|O3|Outcome|Placebo Diskus BID|Placebo twice daily
1124667|NCT00503009|O2|Outcome|FP 250 mcg BID|Fluticasone Propionate (FP) (250 microgram) twice daily
1124668|NCT00503009|O1|Outcome|FSC 250/50 mcg BID|Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
1124669|NCT00503009|O3|Outcome|Placebo Diskus BID|Placebo twice daily
1124670|NCT00503009|O2|Outcome|FP 250 mcg BID|Fluticasone Propionate (FP) (250 microgram) twice daily
1124671|NCT00503009|O1|Outcome|FSC 250/50 mcg BID|Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
1124672|NCT00503009|O3|Outcome|Placebo Diskus BID|Placebo twice daily
1124673|NCT00503009|O2|Outcome|FP 250 mcg BID|Fluticasone Propionate (FP) (250 microgram) twice daily
1124674|NCT00503009|O1|Outcome|FSC 250/50 mcg BID|Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
1124675|NCT00503009|E3|Reported Event|Placebo Diskus BID|Placebo twice daily
1124676|NCT00503009|E2|Reported Event|FP 250 mcg BID|Fluticasone Propionate (FP) (250 microgram) twice daily
1124677|NCT00503009|E1|Reported Event|FSC 250/50 mcg BID|Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
1124678|NCT00502996|B1|Baseline|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
1124679|NCT00502996|P1|Participant Flow|Rituximab|Eligible participants receiving Rituximab (MabThera/Rituxan) 1 gram/dose (g/dose) intravenously (IV) on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 milligram (mg) IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg per oris (PO) weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
1124680|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
1124681|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
1125480|NCT00501943|O2|Outcome|Placebo|"placebo~Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
1124682|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
1124683|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
1124684|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
1124685|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
1124686|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
1124687|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
1124688|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
1124689|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
1124690|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
1124691|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
1124692|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
1124693|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
1124694|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
1124695|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
1124696|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
1124697|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
1124698|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
1124699|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
1124700|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
1124701|NCT00502996|E1|Reported Event|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
1124702|NCT00502944|B3|Baseline|Total|Total of all reporting groups
1124703|NCT00502944|B2|Baseline|Provider|Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
1124704|NCT00502944|B1|Baseline|Counselor|Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.
1124705|NCT00502944|P2|Participant Flow|Provider|Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
1124706|NCT00502944|P1|Participant Flow|Counselor|Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.
1124707|NCT00502944|O2|Outcome|Provider|Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
1124708|NCT00502944|O1|Outcome|Counselor|Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.
1124709|NCT00502944|O2|Outcome|Provider|Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
1124710|NCT00502944|O1|Outcome|Counselor|Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.
1124711|NCT00502944|O2|Outcome|Provider|Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
1126373|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
1124712|NCT00502944|O1|Outcome|Counselor|Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.
1124713|NCT00502944|O2|Outcome|Provider|Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
1124714|NCT00502944|O1|Outcome|Counselor|Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.
1124715|NCT00502944|E2|Reported Event|Provider|Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
1124716|NCT00502944|E1|Reported Event|Counselor|Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.
1124717|NCT00502905|B1|Baseline|Busulfan + Fludarabine|Busulfan 130 mg/m^2 + Fludarabine 40 mg/m^2 given daily for four days
1124718|NCT00502905|P1|Participant Flow|Busulfan + Fludarabine|Busulfan 130 mg/m^2 + Fludarabine 40 mg/m^2 given daily for four days
1124719|NCT00502905|O1|Outcome|Busulfan + Fludarabine|Busulfan 130 mg/m^2 + Fludarabine 40 mg/m^2 given daily for four days
1124720|NCT00502905|E1|Reported Event|Busulfan + Fludarabine|Busulfan 130 mg/m^2 + Fludarabine 40 mg/m^2 given daily for four days
1124721|NCT00502853|B1|Baseline|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
1124722|NCT00502853|P1|Participant Flow|Rituximab Plus (+) Methotrexate (MTX)|Participants received rituximab 1000 milligrams (mg) intravenously (IV) and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg per week (mg/week) by mouth or parenterally. Nonresponsive participants (defined as Disease Activity Score Based on 28-Joint Count and C-Reactive Protein [DAS28-CRP] score of greater than [>]2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
1124723|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
1124724|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
1124725|NCT00502853|O1|Outcome|Rituximab + MTX|"Participants received 1000 mg of Rituximab by IV infusion on Days 1 and 15 (considered to be one cycle). Participants also received 10-25 mg/week stable concomitant MTX by mouth or parenterally.~Additional cycles of 2 infusions each could be administered provided the following: a minimum of 24 weeks had passed since the first infusion of the last course of study medication; the participant had a DAS28-CRP score of >2.6; the participant had a neutrophil count not below 1.5x10^3/μL; there was an absence of significant cardiac or pulmonary disease, primary or secondary immunodeficiency, and infections."
1124726|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
1124727|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
1125481|NCT00501943|O1|Outcome|Riluzole|"Riluzole~Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
1124728|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
1124729|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
1124730|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
1124731|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
1124732|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
1126479|NCT00497055|O1|Outcome|Aripiprazole|aripiprazole daily for 3 months
1124733|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
1124734|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
1124735|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
1124736|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
1124737|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
1124738|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
1124739|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
1124740|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
1124741|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
1124742|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
1124743|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
1125861|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
1124744|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
1124745|NCT00502853|E1|Reported Event|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
1124746|NCT00502840|B1|Baseline|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one cycle). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional cycles of rituximab treatment.
1124747|NCT00502840|P1|Participant Flow|Rituximab Plus Methotrexate (MTX)|Participants received rituximab 1 gram (g), intravenously (IV), and methylprednisolone 100 mg, IV, on Days 1 and 15 (one cycle). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 milligrams (mg) weekly; participants may also have been receiving a stable dose of folic acid. Participants with Disease Activity Score Based on 28 Joint Count (DAS28) greater than or equal to (≥)2.6 and an improvement in DAS28 greater than (>0.6) 16 to 24 weeks following treatment could have received up to two additional cycles of rituximab treatment.
1125707|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
1124748|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
1124749|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
1124750|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
1124751|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
1124752|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
1124753|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
1124754|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
1124755|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
1124756|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
1125482|NCT00501943|O2|Outcome|Placebo|"placebo~Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
1124757|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
1124758|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
1124759|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
1124846|NCT00502593|B8|Baseline|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1126155|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
1124760|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
1124761|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
1124762|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
1124763|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
1124764|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
1124765|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
1124766|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
1124767|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
1124768|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
1124769|NCT00502840|O1|Outcome|Rituximab Pluse MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
1125862|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
1124770|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
1124771|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
1124772|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
1124773|NCT00502840|E1|Reported Event|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
1124774|NCT00502801|B1|Baseline|Doripenem|1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment
1124775|NCT00502801|P1|Participant Flow|Doripenem|1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment
1124776|NCT00502801|O1|Outcome|Doripenem|1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment
1124777|NCT00502801|O1|Outcome|Doripenem|1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment
1124778|NCT00502801|E1|Reported Event|Doripenem|1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment
1124779|NCT00502775|B4|Baseline|Total|Total of all reporting groups
1124780|NCT00502775|B3|Baseline|Fexofenadine 180 mg|
1124781|NCT00502775|B2|Baseline|Fluticasone Furoate 110mcg|
1124782|NCT00502775|B1|Baseline|Placebo|
1124783|NCT00502775|P3|Participant Flow|Fexofenadine 180 mg|
1124784|NCT00502775|P2|Participant Flow|Fluticasone Furoate 110mcg|
1124785|NCT00502775|P1|Participant Flow|Placebo|
1124786|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
1124787|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
1124788|NCT00502775|O1|Outcome|Placebo|
1124789|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
1124790|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
1124791|NCT00502775|O1|Outcome|Placebo|
1124792|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
1124793|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
1124794|NCT00502775|O1|Outcome|Placebo|
1124795|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
1124796|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
1124797|NCT00502775|O1|Outcome|Placebo|
1124798|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
1124799|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
1124800|NCT00502775|O1|Outcome|Placebo|
1124801|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
1124802|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
1124803|NCT00502775|O1|Outcome|Placebo|
1124804|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
1124805|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
1124806|NCT00502775|O1|Outcome|Placebo|
1124807|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
1124808|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
1124809|NCT00502775|O1|Outcome|Placebo|
1124810|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
1124811|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
1124812|NCT00502775|O1|Outcome|Placebo|
1124813|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
1124814|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
1124815|NCT00502775|O1|Outcome|Placebo|
1124816|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
1124817|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
1124818|NCT00502775|O1|Outcome|Placebo|
1124819|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
1124820|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
1124821|NCT00502775|O1|Outcome|Placebo|
1124822|NCT00502775|E3|Reported Event|Fexofenadine 180 mg|
1124823|NCT00502775|E2|Reported Event|Fluticasone Furoate 110mcg|
1124824|NCT00502775|E1|Reported Event|Placebo|
1124825|NCT00502697|B3|Baseline|Total|Total of all reporting groups
1124826|NCT00502697|B2|Baseline|Control Group|"Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.~Conventional prenatal and postpartum clinic care: Women in this group received conventional prenatal care and postpartum clinic care."
1124827|NCT00502697|B1|Baseline|Treatment Group|Advanced practice nurses provide targeted behavioral interventions during home visits. These visits were in addition to regularly scheduled conventional prenatal and postpartum clinic visits. Specific protocols guided nurse interventions related to tobacco use, substance use and misuse, stress management, dental health, maternal infections, perinatal depressive symptoms, family violence, reproductive life plans and continuity of care. Home visits were continued in the postpartum period (18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care.
1137285|NCT00467844|E1|Reported Event|GTx -024|1 mg
1124828|NCT00502697|P2|Participant Flow|Control Group|"Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.~Conventional prenatal and postpartum clinic care : Women in this group received conventional prenatal care and postpartum clinic care."
1124829|NCT00502697|P1|Participant Flow|Intervention Group|Advanced practice nurses provide targeted behavioral interventions during home visits. These visits were in addition to regularly scheduled conventional prenatal and postpartum clinic visits. Specific protocols guided nurse interventions related to tobacco use, substance use and misuse, stress management, dental health, maternal infections, perinatal depressive symptoms, family violence, reproductive life plans and continuity of care. Home visits were continued in the postpartum period (through 18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care.
1124830|NCT00502697|O2|Outcome|Control Group|"Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.~Conventional prenatal and postpartum clinic care: Women in this group received conventional prenatal care and postpartum clinic care."
1124847|NCT00502593|B7|Baseline|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1126156|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
1124831|NCT00502697|O1|Outcome|Intervention Group|Advanced practice nurses provide targeted behavioral interventions during home visits. These visits were in addition to regularly scheduled conventional prenatal and postpartum clinic visits. Specific protocols guided nurse interventions related to tobacco use, substance use and misuse, stress management, dental health, maternal infections, perinatal depressive symptoms, family violence, reproductive life plans and continuity of care. Home visits were continued in the postpartum period (through 18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care.
1124832|NCT00502697|O2|Outcome|Control Group|"Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.~Conventional prenatal and postpartum clinic care: Women in this group received conventional prenatal care and postpartum clinic care."
1124833|NCT00502697|O1|Outcome|Intervention Group|Advanced practice nurses provide targeted behavioral interventions during home visits. These visits were in addition to regularly scheduled conventional prenatal and postpartum clinic visits. Specific protocols guided nurse interventions related to tobacco use, substance use and misuse, stress management, dental health, maternal infections, perinatal depressive symptoms, family violence, reproductive life plans and continuity of care. Home visits were continued in the postpartum period (through 18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care.
1124834|NCT00502697|E2|Reported Event|Control Group|"Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.~Conventional prenatal and postpartum clinic care: Women in this group received conventional prenatal care and postpartum clinic care."
1124835|NCT00502697|E1|Reported Event|Intervention Group|Advanced practice nurses provide targeted behavioral interventions during home visits. These visits were in addition to regularly scheduled conventional prenatal and postpartum clinic visits. Specific protocols guided nurse interventions related to tobacco use, substance use and misuse, stress management, dental health, maternal infections, perinatal depressive symptoms, family violence, reproductive life plans and continuity of care. Home visits were continued in the postpartum period (through 18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care.
1124836|NCT00502671|B1|Baseline|Capecitabine|Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine PO as 1250 mg/m^2 twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
1124837|NCT00502671|P1|Participant Flow|Capecitabine|Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine orally (PO) as 1250 milligrams per meter-squared (mg/m^2) twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
1124838|NCT00502671|O1|Outcome|Capecitabine|Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine PO as 1250 mg/m^2 twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
1124839|NCT00502671|O1|Outcome|Capecitabine|Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine PO as 1250 mg/m^2 twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
1124840|NCT00502671|E1|Reported Event|Capecitabine|Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine PO as 1250 mg/m^2 twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
1124841|NCT00502593|B13|Baseline|Total|Total of all reporting groups
1124842|NCT00502593|B12|Baseline|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125483|NCT00501943|O1|Outcome|Riluzole|"Riluzole~Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
1124843|NCT00502593|B11|Baseline|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124844|NCT00502593|B10|Baseline|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124845|NCT00502593|B9|Baseline|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125583|NCT00501293|E1|Reported Event|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
1124848|NCT00502593|B6|Baseline|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124849|NCT00502593|B5|Baseline|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124850|NCT00502593|B4|Baseline|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124851|NCT00502593|B3|Baseline|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124852|NCT00502593|B2|Baseline|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124853|NCT00502593|B1|Baseline|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124854|NCT00502593|P12|Participant Flow|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124855|NCT00502593|P11|Participant Flow|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124856|NCT00502593|P10|Participant Flow|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124857|NCT00502593|P9|Participant Flow|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124858|NCT00502593|P8|Participant Flow|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124859|NCT00502593|P7|Participant Flow|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124860|NCT00502593|P6|Participant Flow|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124861|NCT00502593|P5|Participant Flow|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124862|NCT00502593|P4|Participant Flow|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124863|NCT00502593|P3|Participant Flow|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125484|NCT00501943|O2|Outcome|Placebo|"placebo~1 tab of Placebo BID added to weekly injection of Interferon beta 1a"
1125485|NCT00501943|O1|Outcome|Riluzole|"Riluzole~Riluzole 50 mg BID added to weekly injection of Interferon beta 1a"
1124864|NCT00502593|P2|Participant Flow|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124865|NCT00502593|P1|Participant Flow|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124866|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124867|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group Subjects Aged 6-9 Years Receive|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124868|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124869|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124870|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124871|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124872|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124873|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124874|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124875|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124876|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124877|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124878|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124879|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124880|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124881|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124882|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124883|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124884|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124885|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124886|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124887|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124888|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124889|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124890|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124891|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124892|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124893|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124894|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124895|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124896|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124897|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124898|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124899|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124900|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124901|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124902|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124903|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124904|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124905|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124906|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124907|NCT00502593|O3|Outcome|GSK1562902A–B Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124908|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124909|NCT00502593|O1|Outcome|GSK1562902A –B Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124910|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124911|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124912|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124913|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124914|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124915|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124916|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124917|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124918|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124919|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124920|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Fluarix–A 3-5Y Group
1124921|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124922|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124923|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124924|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124925|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124926|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124927|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124928|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124929|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125486|NCT00501943|E2|Reported Event|Placebo|"placebo~1 tab of Placebo BID added to weekly injection of Interferon beta 1a"
1125487|NCT00501943|E1|Reported Event|Riluzole|"Riluzole~Riluzole 50 mg BID added to weekly injection of Interferon beta 1a"
1124930|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124931|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124932|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124933|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124934|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124935|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124936|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124937|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124938|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124939|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124940|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124941|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124942|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124943|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124944|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124945|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124946|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124947|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124948|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124949|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124950|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124951|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124952|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124953|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124954|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124955|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124956|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124957|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124958|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124959|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124960|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124961|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124962|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124963|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124964|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124965|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124966|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124967|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124968|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124969|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124970|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124971|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124972|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124973|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124974|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124975|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124976|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124977|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124978|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124979|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124980|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124981|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124982|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124983|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124984|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124985|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124986|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124987|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124988|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124989|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124990|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124991|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124992|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124993|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124994|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124995|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124996|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124997|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124998|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1124999|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125000|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125001|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125002|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125003|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125004|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125005|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125006|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125007|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125008|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125009|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125010|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125011|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125012|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125013|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125014|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125015|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125016|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125017|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125018|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125019|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125020|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125021|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125022|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125023|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125024|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125025|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125026|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125027|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125028|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125029|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125030|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125031|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125032|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125033|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125034|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125035|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125036|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125037|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125038|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125039|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125040|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125041|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125042|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125043|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125044|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125045|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125046|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125047|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125048|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125049|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125050|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125051|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125052|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125053|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125054|NCT00502593|O6|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125055|NCT00502593|O5|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125056|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125057|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125058|NCT00502593|O2|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125059|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125060|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125061|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125062|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125063|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125064|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125065|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125066|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125067|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125068|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125069|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125070|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125071|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125072|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125073|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125074|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125075|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125076|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125077|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125078|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125079|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125080|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125081|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125082|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125083|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125084|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125085|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125086|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125087|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125088|NCT00502593|O6|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125089|NCT00502593|O5|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125090|NCT00502593|O4|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125091|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125092|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125093|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125094|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125095|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125096|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21
1125097|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21
1125098|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125099|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125100|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125101|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125102|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125103|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125104|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125105|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125106|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125107|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125108|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125109|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125110|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125111|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125112|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125113|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125114|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125115|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125116|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125117|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125118|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125119|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125120|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125121|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125122|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125123|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125124|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125125|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125126|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125127|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125128|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125129|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125130|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125131|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125132|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125133|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125134|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125135|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125136|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125137|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125138|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125139|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125140|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125141|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125142|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125143|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125144|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125145|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125146|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125147|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125148|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125149|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125150|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125151|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125152|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125153|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125154|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125155|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125156|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125157|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125158|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125159|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125160|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125161|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125162|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125163|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125164|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125165|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125166|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125167|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125168|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125169|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125170|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125171|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125172|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125173|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125174|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125175|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125176|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125177|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125178|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125179|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125180|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125181|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125182|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125183|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125184|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125185|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125186|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125187|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125188|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125189|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125190|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125191|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125192|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125193|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125194|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125195|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125196|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125197|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125198|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125199|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125200|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125201|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125202|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125203|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125204|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125205|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125206|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125207|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125208|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125209|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125210|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125211|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125212|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125213|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125214|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125215|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125216|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125217|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125218|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125219|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125220|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125221|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125222|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125223|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125224|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125225|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125226|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125227|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125228|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125229|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125230|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125231|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125232|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125233|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125234|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125235|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125236|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125237|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125238|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125239|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125240|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125241|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125242|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125243|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125244|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125245|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125246|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125247|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125248|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125249|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125250|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125251|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125252|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125253|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125254|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125255|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125256|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125257|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125258|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125259|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125260|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125261|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125262|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125263|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125264|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125265|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125266|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125267|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125268|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125269|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125270|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125271|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125272|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125273|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125274|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125275|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125276|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125277|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125278|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125279|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125280|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125281|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125282|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125283|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125284|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125285|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125286|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125287|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125288|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125289|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125290|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125291|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125292|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125293|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125294|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125295|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125296|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125297|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125298|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125299|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125300|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125301|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125302|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125303|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125304|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125305|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125306|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125307|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125308|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125309|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125310|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125311|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125312|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125313|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125314|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125315|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125316|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125317|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125318|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125319|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125320|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125321|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125322|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125323|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125324|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125325|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125326|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125327|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125328|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125329|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125330|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125331|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125332|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125333|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125334|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125335|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125336|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125337|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125338|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125339|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125340|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125341|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125342|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125343|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125344|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125345|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125346|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125347|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125348|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125349|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125350|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125351|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125352|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125353|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125354|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125355|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125356|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125357|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125358|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125359|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125360|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125361|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125362|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125363|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125364|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125365|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125366|NCT00502593|E12|Reported Event|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125367|NCT00502593|E11|Reported Event|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125368|NCT00502593|E10|Reported Event|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125369|NCT00502593|E9|Reported Event|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125370|NCT00502593|E8|Reported Event|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125371|NCT00502593|E7|Reported Event|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125372|NCT00502593|E6|Reported Event|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125373|NCT00502593|E5|Reported Event|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125374|NCT00502593|E4|Reported Event|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125375|NCT00502593|E3|Reported Event|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125376|NCT00502593|E2|Reported Event|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125377|NCT00502593|E1|Reported Event|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
1125378|NCT00502320|B3|Baseline|Total|Total of all reporting groups
1125379|NCT00502320|B2|Baseline|Placebo|inactive sugar pill taken by mouth nightly
1125380|NCT00502320|B1|Baseline|Ramelteon|8 mg pill taken by mouth nightly
1125381|NCT00502320|P2|Participant Flow|Placebo|inactive sugar pill taken by mouth nightly
1125382|NCT00502320|P1|Participant Flow|Ramelteon|8 mg pill taken by mouth nightly
1125383|NCT00502320|O2|Outcome|Placebo|inactive sugar pill taken by mouth nightly
1125384|NCT00502320|O1|Outcome|Ramelteon|8 mg pill taken by mouth nightly
1125385|NCT00502320|O2|Outcome|Placebo|inactive sugar pill taken by mouth nightly
1125386|NCT00502320|O1|Outcome|Ramelteon|8 mg pill taken by mouth nightly
1125387|NCT00502320|O2|Outcome|Placebo|inactive sugar pill taken by mouth nightly
1125388|NCT00502320|O1|Outcome|Ramelteon|8 mg pill taken by mouth nightly
1125389|NCT00502320|E2|Reported Event|Placebo|inactive sugar pill taken by mouth nightly
1125390|NCT00502320|E1|Reported Event|Ramelteon|8 mg pill taken by mouth nightly
1125391|NCT00502242|B3|Baseline|Total|Total of all reporting groups
1125392|NCT00502242|B2|Baseline|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125393|NCT00502242|B1|Baseline|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125394|NCT00502242|P2|Participant Flow|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125395|NCT00502242|P1|Participant Flow|Ramipril|Participants were receiving cyclosporine (CsA) or tacrolimus (TAC) and either mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) or steroids dosed per center’s standard of care. Participants received ramipril, 5 or 10 milligrams per day (mg/d) orally (PO). 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of sirolimus [SRL] initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 nanograms per milliliter [ng/mL] less than [<]1 year post-transplant [PT], 5-15 ng/mL greater than or equal to [≥]1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if urinary protein to creatinine ratio (U p/c) was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125396|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125397|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125584|NCT00501228|B1|Baseline|Filgrastim Injections|
1125585|NCT00501228|P1|Participant Flow|Filgrastim Injections|
1125586|NCT00501228|O1|Outcome|Filgrastim Injections|
1125398|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125399|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125400|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125401|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125402|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125403|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125404|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125462|NCT00501995|E1|Reported Event|IV Cyclophosphamide (50 mg/kg)|"This is an open-labeled single arm study of Cyclophosphamide (50 mg/kg) administered intravenously over 1 hour daily for four consecutive days (200 mg/kg total) through a Hickman catheter .~IV Cyclophosphamide: Cyclophosphamide (50 mg/kg) intravenously daily for 4 consecutive days (total 200 mg/kg) followed by granulocyte colony-stimulating factor (5 µg/kg/day)"
1125463|NCT00501969|B1|Baseline|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
1125405|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125406|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125407|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125408|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125409|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125410|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125411|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125412|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125413|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125464|NCT00501969|P1|Participant Flow|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
1125465|NCT00501969|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
1125466|NCT00501969|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
1125863|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
1125414|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125415|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125416|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125417|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125418|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125419|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125420|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125421|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125422|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125467|NCT00501969|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
1125468|NCT00501969|E1|Reported Event|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
1125469|NCT00501943|B3|Baseline|Total|Total of all reporting groups
1125470|NCT00501943|B2|Baseline|Placebo|"placebo~1 tab of Placebo BID added to weekly injection of Interferon beta 1a"
1125423|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125424|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125425|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125426|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125427|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125428|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125429|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125430|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125431|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125471|NCT00501943|B1|Baseline|Riluzole|"Riluzole~Riluzole 50 mg BID added to weekly injection of Interferon beta 1a"
1125472|NCT00501943|P2|Participant Flow|Placebo|"placebo~1 tab of Placebo BID added to weekly injection of Interferon beta 1a"
1125473|NCT00501943|P1|Participant Flow|Riluzole|"Riluzole~Riluzole 50 mg BID added to weekly injection of Interferon beta 1a"
1125474|NCT00501943|O2|Outcome|Placebo|"placebo~Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
1125432|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125433|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125434|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125435|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125436|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125437|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125438|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125439|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125440|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125475|NCT00501943|O1|Outcome|Riluzole|"Riluzole~Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
1125476|NCT00501943|O2|Outcome|Placebo|"placebo~Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
1125477|NCT00501943|O1|Outcome|Riluzole|"Riluzole~Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
1125864|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
1125441|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125442|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125443|NCT00502242|E2|Reported Event|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125444|NCT00502242|E1|Reported Event|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
1125445|NCT00502216|B3|Baseline|Total|Total of all reporting groups
1125446|NCT00502216|B2|Baseline|Varenicline + Placebo|Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
1125447|NCT00502216|B1|Baseline|Varenicline + Naltrexone|Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day
1125448|NCT00502216|P2|Participant Flow|Varenicline + Placebo|Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
1125449|NCT00502216|P1|Participant Flow|Varenicline + Naltrexone|Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day
1125450|NCT00502216|O2|Outcome|Varenicline + Placebo|Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
1125451|NCT00502216|O1|Outcome|Varenicline + Naltrexone|Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day
1125452|NCT00502216|E2|Reported Event|Varenicline + Placebo|Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
1125453|NCT00502216|E1|Reported Event|Varenicline + Naltrexone|Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day
1125454|NCT00502203|B1|Baseline|Paclitaxel + Carboplatin|Paclitaxel 175 mg/m^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.
1125455|NCT00502203|P1|Participant Flow|Paclitaxel + Carboplatin|Paclitaxel 175 mg/m^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.
1125456|NCT00502203|O1|Outcome|Paclitaxel + Carboplatin|Paclitaxel 175 mg/m^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.
1125457|NCT00502203|E1|Reported Event|Paclitaxel + Carboplatin|Paclitaxel 175 mg/m^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.
1125458|NCT00501995|B1|Baseline|IV Cyclophosphamide (50 mg/kg)|This is an open-labeled single arm study of Cyclophosphamide (50 mg/kg) administered intravenously IV Cyclophosphamide: Cyclophosphamide (50 mg/kg) intravenously daily for 4 consecutive days (total 200 mg/kg) followed by granulocyte colony-stimulating factor (5 µg/kg/day)
1125459|NCT00501995|P1|Participant Flow|IV Cyclophosphamide (50 mg/kg)|"This is an open-labeled single arm study of Cyclophosphamide (50 mg/kg) administered intravenously over 1 hour daily for four consecutive days (200 mg/kg total) through a Hickman catheter .~IV Cyclophosphamide: Cyclophosphamide (50 mg/kg) intravenously daily for 4 consecutive days (total 200 mg/kg) followed by granulocyte colony-stimulating factor (5 µg/kg/day)"
1125460|NCT00501995|O1|Outcome|IV Cyclophosphamide (50 mg/kg)|"This is an open-labeled single arm study of Cyclophosphamide (50 mg/kg) administered intravenously over 1 hour daily for four consecutive days (200 mg/kg total) through a Hickman catheter .~IV Cyclophosphamide: Cyclophosphamide (50 mg/kg) intravenously daily for 4 consecutive days (total 200 mg/kg) followed by granulocyte colony-stimulating factor (5 µg/kg/day)"
1125461|NCT00501995|O1|Outcome|IV Cyclophosphamide (50 mg/kg)|"This is an open-labeled single arm study of Cyclophosphamide (50 mg/kg) administered intravenously over 1 hour daily for four consecutive days (200 mg/kg total) through a Hickman catheter .~IV Cyclophosphamide: Cyclophosphamide (50 mg/kg) intravenously daily for 4 consecutive days (total 200 mg/kg) followed by granulocyte colony-stimulating factor (5 µg/kg/day)"
1125478|NCT00501943|O2|Outcome|Placebo|"placebo~Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
1125479|NCT00501943|O1|Outcome|Riluzole|"Riluzole~Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
1125488|NCT00501891|B1|Baseline|Bevacizumab and Temozolomide|Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
1125489|NCT00501891|P1|Participant Flow|Bevacizumab and Temozolomide|Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
1125490|NCT00501891|O1|Outcome|Bevacizumab and Metromonic Temozolomide|Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
1125491|NCT00501891|O1|Outcome|Bevacizumab and Metronomic Temozolomide|Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
1125587|NCT00501228|E1|Reported Event|Filgrastim Injections|
1125492|NCT00501891|O1|Outcome|Bevacizumab and Metronomic Temozolomide|Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
1125493|NCT00501891|O1|Outcome|Bevacizumab and Metronomic Temozolomide|Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
1125494|NCT00501891|E1|Reported Event|Bevacizumab and Temozolomide|Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
1125495|NCT00501852|B1|Baseline|Overall Study|
1125496|NCT00501852|P1|Participant Flow|Overall Study|
1125497|NCT00501852|O6|Outcome|Tiotropium Bromide|18 µg od via Handihaler inhaler. Tiotropium was given open-label. At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
1125498|NCT00501852|O5|Outcome|Placebo|Placebo via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
1125499|NCT00501852|O4|Outcome|NVA237 100 ug|100 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
1125500|NCT00501852|O3|Outcome|NVA237 50 ug|50 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
1125501|NCT00501852|O2|Outcome|NVA237 25 ug|25 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
1125502|NCT00501852|O1|Outcome|NVA237 12.5 ug|12.5 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
1125503|NCT00501852|O6|Outcome|Tiotropium Bromide|18 µg od via Handihaler inhaler. Tiotropium was given open-label. At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
1125504|NCT00501852|O5|Outcome|Placebo|Placebo via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
1125505|NCT00501852|O4|Outcome|NVA237 100 ug|100 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
1125506|NCT00501852|O3|Outcome|NVA237 50 ug|50 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
1125507|NCT00501852|O2|Outcome|NVA237 25 ug|25 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
1125508|NCT00501852|O1|Outcome|NVA237 12.5 ug|12.5 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
1125509|NCT00501852|E6|Reported Event|Tiotropium Bromide|18 µg od via Handihaler inhaler. Tiotropium was given open-label. At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
1125510|NCT00501852|E5|Reported Event|Placebo|Placebo via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
1125511|NCT00501852|E4|Reported Event|NVA237 100 ug|100 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
1125512|NCT00501852|E3|Reported Event|NVA237 50 ug|50 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
1138832|NCT00464438|P1|Participant Flow|Gatifloxacin 0.3%|
1125513|NCT00501852|E2|Reported Event|NVA237 25 ug|25 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
1125514|NCT00501852|E1|Reported Event|NVA237 12.5 ug|12.5 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
1125515|NCT00501644|B1|Baseline|Chemoimmunotherapy|GM-CSF Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy + rIFN-g (Interferon Gamma) 0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle) + Paraplatin (Carboplatin) AUC of 5 by 1 hour IV infusion every 28 days
1125516|NCT00501644|P1|Participant Flow|Chemoimmunotherapy|GM-CSF Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy + rIFN-g (Interferon Gamma) 0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle) + Paraplatin (Carboplatin) AUC of 5 by 1 hour IV infusion every 28 days
1125517|NCT00501644|O1|Outcome|Chemoimmunotherapy|GM-CSF Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy + rIFN-g (Interferon Gamma) 0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle) + Paraplatin (Carboplatin) AUC of 5 by 1 hour IV infusion every 28 days
1125518|NCT00501644|E1|Reported Event|Chemoimmunotherapy|GM-CSF Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy + rIFN-g (Interferon Gamma) 0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle) + Paraplatin (Carboplatin) AUC of 5 by 1 hour IV infusion every 28 days
1125519|NCT00501631|B3|Baseline|Total|Total of all reporting groups
1125520|NCT00501631|B2|Baseline|Placebo for VIVITROL 380 mg|All subjects who received at least 1 injection of Placebo for VIVITROL. Arm includes all subjects who received at least 1 injection of placebo. After successfully completing screening subjects were administered placebo by intramuscular (IM) injection every 4 weeks for a total of 3 injections. Randomization was 1:1 (VIVITROL:placebo) and stratified by site.
1125521|NCT00501631|B1|Baseline|VIVITROL 380 mg|Arm includes all subjects who received at least 1 injection of VIVITROL. After successfully completing screening subjects were administered VIVITROL 380 mg by intramuscular (IM) injection every 4 weeks for a total of 3 injections. Randomization was 1:1 (VIVITROL:placebo) and stratified by site.
1125522|NCT00501631|P2|Participant Flow|Placebo for VIVITROL 380 mg|All subjects who received at least 1 injection of Placebo for VIVITROL. Arm includes all subjects who received at least 1 injection of placebo. After successfully completing screening subjects were administered placebo by intramuscular (IM) injection every 4 weeks for a total of 3 injections. Randomization was 1:1 (VIVITROL:placebo) and stratified by site.
1125523|NCT00501631|P1|Participant Flow|VIVITROL 380 mg|Arm includes all subjects who received at least 1 injection of VIVITROL. After successfully completing screening subjects were administered VIVITROL 380 mg by intramuscular (IM) injection every 4 weeks for a total of 3 injections. Randomization was 1:1 (VIVITROL:placebo) and stratified by site.
1125524|NCT00501631|O2|Outcome|Placebo|
1125525|NCT00501631|O1|Outcome|Vivitrol|
1125526|NCT00501631|E2|Reported Event|Placebo for VIVITROL 380 mg (Double-blind Period)|
1125527|NCT00501631|E1|Reported Event|VIVITROL 380 mg (Double-blind Period)|
1125528|NCT00501592|B4|Baseline|Total|Total of all reporting groups
1125529|NCT00501592|B3|Baseline|Placebo|Once daily by mouth
1125530|NCT00501592|B2|Baseline|50 mg INT-747|Once daily by mouth
1125531|NCT00501592|B1|Baseline|25 mg INT-747|Once daily by mouth
1125532|NCT00501592|P3|Participant Flow|Placebo|Once daily by mouth
1125533|NCT00501592|P2|Participant Flow|50 mg INT-747|Once daily by mouth
1125534|NCT00501592|P1|Participant Flow|25 mg INT-747|Once daily by mouth
1125535|NCT00501592|O3|Outcome|Placebo|Once daily by mouth
1125536|NCT00501592|O2|Outcome|50 mg INT-747|Once daily by mouth
1125537|NCT00501592|O1|Outcome|25 mg INT-747|Once daily by mouth
1125538|NCT00501592|O3|Outcome|Placebo|Once daily by mouth
1125539|NCT00501592|O2|Outcome|50 mg INT-747|Once daily by mouth
1125540|NCT00501592|O1|Outcome|25 mg INT-747|Once daily by mouth
1125541|NCT00501592|E3|Reported Event|Placebo|Once daily by mouth
1125542|NCT00501592|E2|Reported Event|50 mg INT-747|Once daily by mouth
1125543|NCT00501592|E1|Reported Event|25 mg INT-747|Once daily by mouth
1125544|NCT00501540|B1|Baseline|Lithium|"Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment.~Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks."
1125545|NCT00501540|P1|Participant Flow|Lithium|"Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment.~Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks."
1125546|NCT00501540|O1|Outcome|Lithium|"Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment.~Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks."
1125578|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
1125865|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
1125547|NCT00501540|O1|Outcome|Lithium|"Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment.~Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks."
1125548|NCT00501540|O1|Outcome|Lithium|"Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment.~Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks."
1125588|NCT00501085|B1|Baseline|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.~LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
1125549|NCT00501540|E1|Reported Event|Lithium|"Lithium carbonate was dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate was provided as a 300mg tablet and was taken daily without breaks in treatment.~Lithium Carbonate: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate was administered the first week at 300 mg flat dose three times each day. A serum lithium level was checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluated every 8 weeks."
1125550|NCT00501345|B1|Baseline|Aspirin|325 mg by mouth Day 1, 160 mg daily thereafter
1125551|NCT00501345|P1|Participant Flow|Aspirin|325 mg by mouth Day 1, 160 mg daily thereafter
1125552|NCT00501345|O1|Outcome|Aspirin|325 mg by mouth Day 1, 160 mg daily thereafter
1125553|NCT00501345|E1|Reported Event|Aspirin|325 mg by mouth Day 1, 160 mg daily thereafter
1125554|NCT00501293|B3|Baseline|Total|Total of all reporting groups
1125555|NCT00501293|B2|Baseline|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
1125556|NCT00501293|B1|Baseline|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
1125557|NCT00501293|P2|Participant Flow|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
1125558|NCT00501293|P1|Participant Flow|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
1125559|NCT00501293|O1|Outcome|Antecedent MTS and Antecedent Placebo|Methylphenidate Transdermal System and Placebo Patch
1125560|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
1125561|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
1125562|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
1125563|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
1125564|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
1125565|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
1125566|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
1125567|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
1125568|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
1125569|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
1125570|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
1125571|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
1125572|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
1125573|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
1125574|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
1125575|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
1125576|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
1125577|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
1125579|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
1125580|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
1125581|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
1125582|NCT00501293|E2|Reported Event|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
1125669|NCT00500578|E1|Reported Event|Standard Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 18 hours every 24 hours
1125589|NCT00501085|P1|Participant Flow|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.~LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
1125590|NCT00501085|O1|Outcome|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.~LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
1125591|NCT00501085|O1|Outcome|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.~LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
1125592|NCT00501085|O1|Outcome|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.~LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
1125593|NCT00501085|O1|Outcome|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.~LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
1125594|NCT00501085|O1|Outcome|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.~LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
1125595|NCT00501085|E1|Reported Event|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.~LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
1125596|NCT00501046|B3|Baseline|Total|Total of all reporting groups
1125597|NCT00501046|B2|Baseline|Placebo|Placebo: 9g /day (3 times a day)
1125598|NCT00501046|B1|Baseline|AST-120|AST-120: 9g /day (3 times a day)
1125599|NCT00501046|P2|Participant Flow|Placebo|Placebo: 9g /day (3 times a day)
1125600|NCT00501046|P1|Participant Flow|AST-120|AST-120: 9g /day (3 times a day)
1125601|NCT00501046|O2|Outcome|Placebo|Placebo: 9g /day (3 times a day)
1125602|NCT00501046|O1|Outcome|AST-120|AST-120: 9g /day (3 times a day)
1125603|NCT00501046|E2|Reported Event|Placebo|Placebo: 9g /day (3 times a day)
1125604|NCT00501046|E1|Reported Event|AST-120|AST-120: 9g /day (3 times a day)
1125605|NCT00501007|B1|Baseline|Diagnosis|Non-psychiatric group vs. Schizophrenia / Schizoaffective disorder
1125606|NCT00501007|P2|Participant Flow|Smokers With Schizophrenia / Schizoaffective Disorder|Smokers meeting criteria for schizophrenia or schizoaffective disorder
1125607|NCT00501007|P1|Participant Flow|Non-psychiatric Smokers|Smokers without a diagnosis of schizophrenia or schizoaffective disorder
1125608|NCT00501007|O1|Outcome|Smoking Cessation|Participants received tobacco dependence treatment
1125609|NCT00501007|O2|Outcome|Non-psychiatric Group|Smokers NOT meeting criteria for schizophrenia, schizophrenia, bipolar disorder.
1125610|NCT00501007|O1|Outcome|Schizophrenia or Schizoaffective Disorder|Smokers meeting Diagnostic and Statistical Manual criteria for Schizophrenia or Schizoaffective Disorder
1125611|NCT00501007|E1|Reported Event|Diagnosis|Non-psychiatric group vs. Schizophrenia / Schizoaffective disorder
1125612|NCT00500760|B3|Baseline|Total|Total of all reporting groups
1125613|NCT00500760|B2|Baseline|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
1125614|NCT00500760|B1|Baseline|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
1125615|NCT00500760|P2|Participant Flow|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
1125616|NCT00500760|P1|Participant Flow|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
1125617|NCT00500760|O2|Outcome|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
1125618|NCT00500760|O1|Outcome|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
1125619|NCT00500760|O2|Outcome|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
1125620|NCT00500760|O1|Outcome|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
1125621|NCT00500760|O2|Outcome|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
1125622|NCT00500760|O1|Outcome|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
1125866|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
1125623|NCT00500760|O2|Outcome|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
1125624|NCT00500760|O1|Outcome|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
1125625|NCT00500760|O2|Outcome|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
1125626|NCT00500760|O1|Outcome|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
1125627|NCT00500760|O2|Outcome|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
1125628|NCT00500760|O1|Outcome|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
1125629|NCT00500760|O2|Outcome|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
1125630|NCT00500760|O1|Outcome|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
1125631|NCT00500760|E2|Reported Event|Chemotherapy Plus Radiotherapy|
1126480|NCT00497055|E2|Reported Event|Placebo|placebo daily for 3 months
1125632|NCT00500760|E1|Reported Event|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
1125633|NCT00500682|B3|Baseline|Total|Total of all reporting groups
1125634|NCT00500682|B2|Baseline|Placebo|Placebo: 9g /day (3 times a day)
1125635|NCT00500682|B1|Baseline|AST-120|AST-120: 9g /day (3 times a day)
1125636|NCT00500682|P2|Participant Flow|Placebo|Placebo: 9g /day (3 times a day)
1125637|NCT00500682|P1|Participant Flow|AST-120|AST-120: 9g /day (3 times a day)
1125638|NCT00500682|O2|Outcome|Placebo|Placebo: 9g /day (3 times a day)
1125639|NCT00500682|O1|Outcome|AST-120|AST-120: 9g /day (3 times a day)
1125640|NCT00500682|E2|Reported Event|Placebo|Placebo: 9g /day (3 times a day)
1125641|NCT00500682|E1|Reported Event|AST-120|AST-120: 9g /day (3 times a day)
1125642|NCT00500656|B5|Baseline|Total|Total of all reporting groups
1125643|NCT00500656|B4|Baseline|Untreated Patients at the Baseline|Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing were treated in the open label phase with icatibant
1125644|NCT00500656|B3|Baseline|Controlled Open-label / Laryngeal Attack|Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase.
1125645|NCT00500656|B2|Baseline|Randomized Controlled-Tranexamic Acid|Patients who were randomized to received oral Tranexamic acid + S.C. placebo(solution for injection, matched to icatibant for injection) in the controlled phase after they had an eligible first in-study attack.
1125646|NCT00500656|B1|Baseline|Randomized Controlled -Icatibant|Patients who were randomized to icatibant + Oral placebo (hard capsule matched to tranexamic acid) in the controlled phase after they had an eligible first in-study attack.
1125647|NCT00500656|P4|Participant Flow|Untreated Patients at the Baseline|Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing were treated in the open label phase with icatibant
1125648|NCT00500656|P3|Participant Flow|Controlled Open-label / Laryngeal Attack|Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase.
1125649|NCT00500656|P2|Participant Flow|Randomized Controlled-Tranexamic Acid|Patients who were randomized to received oral Tranexamic acid + S.C. placebo(solution for injection, matched to icatibant for injection) in the controlled phase after they had an eligible first in-study attack.
1125650|NCT00500656|P1|Participant Flow|Randomized Controlled -Icatibant|Patients who were randomized to icatibant + Oral placebo (hard capsule matched to tranexamic acid) in the controlled phase after they had an eligible first in-study attack.
1125651|NCT00500656|O2|Outcome|Randomized Controlled-Tranexamic Acid|Patients who were randomized to received oral Tranexamic acid + S.C. placebo(solution for injection, matched to icatibant for injection) in the controlled phase after they had an eligible first in-study attack.
1125652|NCT00500656|O1|Outcome|Randomized Controlled -Icatibant|Patients who were randomized to icatibant + Oral placebo (hard capsule matched to tranexamic acid) in the controlled phase after they had an eligible first in-study attack.
1125653|NCT00500656|O2|Outcome|Randomized Controlled-Tranexamic Acid|Patients who were randomized to received oral Tranexamic acid + S.C. placebo(solution for injection, matched to icatibant for injection) in the controlled phase after they had an eligible first in-study attack.
1125654|NCT00500656|O1|Outcome|Randomized Controlled -Icatibant|Patients who were randomized to icatibant + Oral placebo (hard capsule matched to tranexamic acid) in the controlled phase after they had an eligible first in-study attack.
1125655|NCT00500656|E6|Reported Event|Open Label Extension Phase(Untreated Patients at the Baseline|This represents adverse events experienced by Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing.
1125656|NCT00500656|E5|Reported Event|Open Label Extension Phase (Subjects w/ Laryngeal Attack)|This represents adverse events during the open label extension phase that were experienced by Patients with laryngeal symptoms at the baseline and got treated with open label icatibant during the controlled phase and Open label extension phase.
1125657|NCT00500656|E4|Reported Event|Open Label Extension Phase- Icatibant (Previously Randomized)|Patients who were randomized to either icatibant+ oral placebo or Tranexamic acid+ S.C. placebo in the controlled phase and experienced adverse events while participating in the open label extension phase.
1125658|NCT00500656|E3|Reported Event|Controlled Phase- Icatibant (Subjects w/ Laryngeal Attack)|This represents adverse events during the controlled phase that were experienced by Patients with laryngeal symptoms at the baseline and were treated with open label icatibant during the controlled phase.
1125781|NCT00500292|E1|Reported Event|Vandetanib 100 mg Plus FOLFOX|vandetanib 100 mg plus FOLFOX
1125659|NCT00500656|E2|Reported Event|Controlled Phase- Tranexamic Acid (Randomized Subjects)|Patients who were randomized to Tranexamic acid+ S.C. placebo in the controlled phase and experienced adverse events while participating in the controlled phase.
1125660|NCT00500656|E1|Reported Event|Controlled Phase- Icatibant (Randomized Subjects )|Patients who were randomized to icatibant+ oral placebo in the controlled phase and experienced adverse events while participating in the controlled phase
1125661|NCT00500578|B3|Baseline|Total|Total of all reporting groups
1125662|NCT00500578|B2|Baseline|Modified Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 3 hours every 8 hours
1125663|NCT00500578|B1|Baseline|Standard Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 18 hours every 24 hours
1125664|NCT00500578|P2|Participant Flow|Modified Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 3 hours every 8 hours
1125665|NCT00500578|P1|Participant Flow|Standard Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 18 hours every 24 hours
1125666|NCT00500578|O2|Outcome|Modified Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 3 hours every 8 hours
1125667|NCT00500578|O1|Outcome|Standard Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 18 hours every 24 hours
1125668|NCT00500578|E2|Reported Event|Modified Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 3 hours every 8 hours
1126481|NCT00497055|E1|Reported Event|Aripiprazole|aripiprazole daily for 3 months
1125670|NCT00500539|B1|Baseline|Omalizumab|The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
1125671|NCT00500539|P1|Participant Flow|Omalizumab|The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
1125672|NCT00500539|O1|Outcome|Follow-up Period|Participants were assessed at 16 weeks after the last dose of study drug
1125673|NCT00500539|O1|Outcome|Treatment Period|The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
1125674|NCT00500539|O1|Outcome|Follow-up Period|Participants were evaluated at 16 weeks after the last dose of study drug.
1125675|NCT00500539|E2|Reported Event|Omalizumab Follow up Period|Participants were assessed at 16 weeks after the last dose of study drug
1125676|NCT00500539|E1|Reported Event|Omalizumab Treatment Period|The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
1125677|NCT00500448|B3|Baseline|Total|Total of all reporting groups
1125678|NCT00500448|B2|Baseline|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks~Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
1125679|NCT00500448|B1|Baseline|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
1125680|NCT00500448|P2|Participant Flow|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks~Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
1125681|NCT00500448|P1|Participant Flow|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
1125682|NCT00500448|O2|Outcome|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks~Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
1125683|NCT00500448|O1|Outcome|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
1125684|NCT00500448|O2|Outcome|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks~Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
1125685|NCT00500448|O1|Outcome|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
1125686|NCT00500448|O2|Outcome|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks~Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
1125687|NCT00500448|O1|Outcome|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
1125688|NCT00500448|O2|Outcome|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks~Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
1125689|NCT00500448|O1|Outcome|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
1125690|NCT00500448|O2|Outcome|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks~Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
1125691|NCT00500448|O1|Outcome|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
1125692|NCT00500448|E2|Reported Event|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks~Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
1125693|NCT00500448|E1|Reported Event|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
1125694|NCT00500370|B3|Baseline|Total|Total of all reporting groups
1125695|NCT00500370|B2|Baseline|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
1125696|NCT00500370|B1|Baseline|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
1125697|NCT00500370|P2|Participant Flow|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
1125698|NCT00500370|P1|Participant Flow|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
1125699|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
1125700|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
1125701|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
1125702|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
1125703|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
1125704|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
1125705|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
1125706|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
1126482|NCT00496964|B3|Baseline|Total|Total of all reporting groups
1125708|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
1125709|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
1125710|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
1125711|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
1125712|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
1125713|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
1125714|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
1125715|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
1125716|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
1125717|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
1125718|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
1125719|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
1125720|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
1125721|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
1125722|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
1125723|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
1125724|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
1125725|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
1125726|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
1125727|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
1125728|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
1125729|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
1125730|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
1125731|NCT00500370|E2|Reported Event|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
1125732|NCT00500370|E1|Reported Event|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
1125733|NCT00500357|B1|Baseline|13vPnC (Vax 3 Follow-up / NCT00500357)|Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
1125734|NCT00500357|P1|Participant Flow|13vPnC (Vax 3 Follow-up / NCT00500357)|Administered 13vPnC 0.5 milliliters (mL) intramuscularly (IM) at Year 0 (Vaccination 1 [Vax 1]) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
1125735|NCT00500357|O2|Outcome|13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)|13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) core study/NCT00269672. Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
1125736|NCT00500357|O1|Outcome|13vPnC / 23vPS (Vax 2 Core Study/NCT00269672)|13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500).
1138833|NCT00464438|O2|Outcome|Moxifloxacin 0.5%|
1125737|NCT00500357|O2|Outcome|13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)|13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672. Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
1125738|NCT00500357|O1|Outcome|13vPnC (Vax 1 Core Study/NCT00269672)|13vPnC 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500).
1125739|NCT00500357|O2|Outcome|13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)|13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) core study/NCT00269672. Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
1125740|NCT00500357|O1|Outcome|13vPnC / 23vPS (Vax 2 Core Study/NCT00269672)|13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500).
1125741|NCT00500357|O1|Outcome|13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up/NCT00500357)|Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
1125742|NCT00500357|O1|Outcome|13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up/NCT00500357)|Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
1126157|NCT00497770|E4|Reported Event|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
1125743|NCT00500357|O2|Outcome|13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)|13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
1125744|NCT00500357|O1|Outcome|13vPnC (Vax 1 Core Study/NCT00269672)|13vPnC 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500).
1125745|NCT00500357|E7|Reported Event|13vPnC-AlPO4/23vPS (After Vax 2 Core Study)|Administered 13vPnC-AlPO4 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
1125746|NCT00500357|E6|Reported Event|13vPnC+AlPO4/23vPS (After Vax 2 Core Study)|Administered 13vPnC+AlPO4 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
1125747|NCT00500357|E5|Reported Event|13vPnC+AlPO4/13vPnC+AlPO4 (After Vax 2 Core Study)|Administered 13vPnC + AlPO4 0.5 mL IM at Year 0 (Vax 1) followed by 13vPnC+AlPO4 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
1125748|NCT00500357|E4|Reported Event|23vPS (After Vax 1 Core Study)|Administered 23vPS 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
1125749|NCT00500357|E3|Reported Event|13vPnC-AlPO4 (After Vax 1 Core Study)|Administered 13vPnC-AlPO4 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
1125750|NCT00500357|E2|Reported Event|13vPnC+AlPO4 (After Vax 1 Core Study)|Administered 13vPnC+AlPO4 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
1125751|NCT00500357|E1|Reported Event|13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study)|"Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).~For 13vPnC / 23vPS / 13vPnC (Vax 3 follow-up study) Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=7; systematic (solicited) Any Local Reactions N=41; systematic (solicited) Any Systemic Events N=46."
1125752|NCT00500318|B3|Baseline|Total|Total of all reporting groups
1125753|NCT00500318|B2|Baseline|Placebo|Dose-matched placebo, oral inhalation, once per day.
1125754|NCT00500318|B1|Baseline|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
1125755|NCT00500318|P2|Participant Flow|Placebo|Dose-matched placebo, oral inhalation, once per day.
1125756|NCT00500318|P1|Participant Flow|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
1125757|NCT00500318|O2|Outcome|Placebo|Dose-matched placebo, oral inhalation, once per day.
1125758|NCT00500318|O1|Outcome|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
1125759|NCT00500318|O2|Outcome|Placebo|Dose-matched placebo, oral inhalation, once per day.
1125760|NCT00500318|O1|Outcome|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
1125761|NCT00500318|O2|Outcome|Placebo|Dose-matched placebo, oral inhalation, once per day.
1125762|NCT00500318|O1|Outcome|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
1125763|NCT00500318|O2|Outcome|Placebo|Dose-matched placebo, oral inhalation, once per day.
1125764|NCT00500318|O1|Outcome|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
1125765|NCT00500318|O2|Outcome|Placebo|Dose-matched placebo, oral inhalation, once per day.
1125766|NCT00500318|O1|Outcome|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
1125767|NCT00500318|E2|Reported Event|Placebo|Dose-matched placebo, oral inhalation, once per day.
1125768|NCT00500318|E1|Reported Event|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
1125769|NCT00500292|B4|Baseline|Total|Total of all reporting groups
1125770|NCT00500292|B3|Baseline|Placebo Plus FOLFOX|placebo plus FOLFOX
1125771|NCT00500292|B2|Baseline|Vandetanib 300 mg Plus FOLFOX|vandetanib 300 mg plus FOLFOX
1125772|NCT00500292|B1|Baseline|Vandetanib 100 mg Plus FOLFOX|vandetanib 100 mg plus FOLFOX
1125773|NCT00500292|P3|Participant Flow|Placebo Plus FOLFOX|placebo plus FOLFOX
1125774|NCT00500292|P2|Participant Flow|Vandetanib 300 mg Plus FOLFOX|vandetanib 300 mg plus FOLFOX
1125775|NCT00500292|P1|Participant Flow|Vandetanib 100 mg Plus FOLFOX|vandetanib 100 mg plus FOLFOX
1125776|NCT00500292|O3|Outcome|Placebo Plus FOLFOX|placebo plus FOLFOX
1125777|NCT00500292|O2|Outcome|Vandetanib 300 mg Plus FOLFOX|vandetanib 300 mg plus FOLFOX
1125778|NCT00500292|O1|Outcome|Vandetanib 100 mg Plus FOLFOX|vandetanib 100 mg plus FOLFOX
1125779|NCT00500292|E3|Reported Event|Placebo Plus FOLFOX|placebo plus FOLFOX
1125780|NCT00500292|E2|Reported Event|Vandetanib 300 mg Plus FOLFOX|vandetanib 300 mg plus FOLFOX
1138834|NCT00464438|O1|Outcome|Gatifloxacin 0.3%|
1125782|NCT00500266|B1|Baseline|13vPnC|Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
1125783|NCT00500266|P1|Participant Flow|13vPnC|Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
1125784|NCT00500266|O1|Outcome|13vPnC|Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
1125785|NCT00500266|O1|Outcome|13vPnC|Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
1125786|NCT00500266|O1|Outcome|13vPnC|Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
1125787|NCT00500266|E2|Reported Event|13vPnC: 6-month Follow-up|Participants received a single 0.5 mL dose of 13vPnC into the deltoid muscle of the arm once during the study. At visit 3, the 6-month follow-up (166-194 days after Visit 1) only newly diagnosed chronic medical conditions were collected as AEs. SAEs were collected throughout the study.
1126012|NCT00499369|E5|Reported Event|Cohort II: Chemotherapy + Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1125788|NCT00500266|E1|Reported Event|13vPnC: Visit 1 to Visit 2|Participants received a single 0.5 mL dose of 13vPnC into the deltoid muscle of the arm once during the study. Local reactions and systemic events were collected from Day 1 through Day 14. AEs were recorded from Visit 1 to Visit 2 (29-43 days after Visit 1). SAEs were collected throughout the study.
1125789|NCT00500240|B3|Baseline|Total|Total of all reporting groups
1125790|NCT00500240|B2|Baseline|Intensive Insulin|Intervention Group: Intense blood sugar management with Insulin Aspart + Insulin Glargine
1125791|NCT00500240|B1|Baseline|Conventional Care|Control Group: Conventional care using blood sugar management with regular human insulin.
1125792|NCT00500240|P2|Participant Flow|Intensive Insulin|Intervention Group: Intense blood sugar management with Insulin Aspart + Insulin Glargine
1125793|NCT00500240|P1|Participant Flow|Conventional Care|Control Group: Conventional care using blood sugar management with regular human insulin.
1125794|NCT00500240|O2|Outcome|Intensive Insulin|Intervention Group - Intense blood sugar management with Insulin Aspart + Insulin Glargine
1125795|NCT00500240|O1|Outcome|Conventional Care|Control Group - Conventional care using blood sugar management with regular human insulin.
1125796|NCT00500240|O2|Outcome|Intervention Group|Intense blood sugar management with Insulin Aspart + Insulin Glargine
1125797|NCT00500240|O1|Outcome|Conventional Care|Control Group - Conventional care using blood sugar management with regular human insulin
1125798|NCT00500240|O2|Outcome|Intensive Insulin|Intervention Group - Intense blood sugar management with Insulin Aspart + Insulin Glargine
1125799|NCT00500240|O1|Outcome|Conventional Care|Control Group - Conventional care using blood sugar management with regular human insulin.
1125800|NCT00500240|E2|Reported Event|Intensive Insulin|Intervention Group: Intense blood sugar management with Insulin Aspart + Insulin Glargine
1125801|NCT00500240|E1|Reported Event|Conventional Care|Control Group: Conventional care using blood sugar management with regular human insulin.
1125802|NCT00500149|B1|Baseline|Entire Study Population|
1125803|NCT00500149|P2|Participant Flow|Placebo First|Matching placebo was given orally once daily for 1 week in the first intervention and Vyvanse was dosed orally once daily at either 30, 50 or 70 mg (depending on the outcome of the dose optimization phase)for 1 week in the second intervention
1125804|NCT00500149|P1|Participant Flow|Vyvanse First|Vyvanse was dosed orally once daily at either 30, 50 or 70 mg (depending on the outcome of the dose optimization phase)for 1 week in the first intervention and matching placebo was given orally once daily for 1 week in the second intervention
1125805|NCT00500149|O2|Outcome|Placebo|Matching placebo
1125806|NCT00500149|O1|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
1125807|NCT00500149|O2|Outcome|Placebo|Matching placebo
1125808|NCT00500149|O1|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
1125809|NCT00500149|E2|Reported Event|Placebo|
1125810|NCT00500149|E1|Reported Event|Vyvanse|
1125811|NCT00500110|B1|Baseline|Hormonal Ablation, Imatinib + Docetaxel|Imatinib Mesylate 600 mg by mouth (PO) daily + Docetaxel 30 mg/m^2 by vein (IV) weekly + Hormonal Ablation (Goserelin Acetate or Leuprolide) injections every other month or every 3 months
1125812|NCT00500110|P1|Participant Flow|Hormonal Ablation, Imatinib + Docetaxel|Imatinib Mesylate 600 mg by mouth (PO) daily + Docetaxel 30 mg/m^2 by vein (IV) weekly + Hormonal Ablation (Goserelin Acetate or Leuprolide) injections every other month or every 3 months
1125813|NCT00500110|O1|Outcome|Treatment|
1125814|NCT00500110|E1|Reported Event|Hormonal Ablation, Imatinib + Docetaxel|Imatinib Mesylate 600 mg by mouth (PO) daily + Docetaxel 30 mg/m^2 by vein (IV) weekly + Hormonal Ablation (Goserelin Acetate or Leuprolide) injections every other month or every 3 months
1125815|NCT00500071|B1|Baseline|Vyvanse|Lisdexamfetamine dimesylate (LDX)
1125816|NCT00500071|P1|Participant Flow|Vyvanse|Lisdexamfetamine dimesylate (LDX)
1125817|NCT00500071|O1|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
1125818|NCT00500071|O1|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
1125819|NCT00500071|O1|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
1125820|NCT00500071|O1|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
1125821|NCT00500071|O1|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
1125822|NCT00500071|O1|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
1125823|NCT00500071|E1|Reported Event|Vyvanse|Lisdexamfetamine dimesylate (LDX)
1125824|NCT00499915|B3|Baseline|Total|Total of all reporting groups
1125825|NCT00499915|B2|Baseline|Comparison|"Parents of children in the active comparator group will receive asthma education at NICU discharge.~Asthma Education with Secondhand Smoke Reduction: Parents of children in the active comparator group will receive asthma education at NICU discharge but no secondhand smoke reduction program will be implemented."
1125826|NCT00499915|B1|Baseline|Treatment|"Parents of children in the experimental group will receive asthma education at NICU discharge as well as secondhand smoke reduction program.~Secondhand Smoke Reduction, Smoking Cessation: Parents of children in the experimental group will receive asthma education at NICU discharge as well as a secondhand smoke reduction program including feedback about the children's cotinine levels."
1125857|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
1125827|NCT00499915|P2|Participant Flow|Comparison|"Parents of children in the active comparator group will receive asthma education at NICU discharge.~Asthma Education with Secondhand Smoke Reduction: Parents of children in the active comparator group will receive asthma education at NICU discharge but no secondhand smoke reduction program will be implemented."
1125828|NCT00499915|P1|Participant Flow|Treatment|"Parents of children in the experimental group will receive asthma education at NICU discharge as well as secondhand smoke reduction program.~Secondhand Smoke Reduction, Smoking Cessation: Parents of children in the experimental group will receive asthma education at NICU discharge as well as a secondhand smoke reduction program including feedback about the children's cotinine levels."
1125829|NCT00499915|O2|Outcome|Comparison|"Parents of children in the active comparator group will receive asthma education at NICU discharge.~Asthma Education with Secondhand Smoke Reduction: Parents of children in the active comparator group will receive asthma education at NICU discharge but no secondhand smoke reduction program will be implemented."
1126158|NCT00497770|E3|Reported Event|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
1125830|NCT00499915|O1|Outcome|Treatment|"Parents of children in the experimental group will receive asthma education at NICU discharge as well as secondhand smoke reduction program.~Secondhand Smoke Reduction, Smoking Cessation: Parents of children in the experimental group will receive asthma education at NICU discharge as well as a secondhand smoke reduction program including feedback about the children's cotinine levels."
1125831|NCT00499915|E2|Reported Event|Comparison|"Parents of children in the active comparator group will receive asthma education at NICU discharge.~Asthma Education with Secondhand Smoke Reduction: Parents of children in the active comparator group will receive asthma education at NICU discharge but no secondhand smoke reduction program will be implemented."
1125832|NCT00499915|E1|Reported Event|Treatment|"Parents of children in the experimental group will receive asthma education at NICU discharge as well as secondhand smoke reduction program.~Secondhand Smoke Reduction, Smoking Cessation: Parents of children in the experimental group will receive asthma education at NICU discharge as well as a secondhand smoke reduction program including feedback about the children's cotinine levels."
1125833|NCT00499889|B1|Baseline|Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin|Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
1125834|NCT00499889|P1|Participant Flow|Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin|Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
1125835|NCT00499889|O1|Outcome|Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin|Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
1125836|NCT00499889|O1|Outcome|Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin|Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
1125837|NCT00499889|O1|Outcome|Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin|Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
1125838|NCT00499889|E1|Reported Event|Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin|Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
1125839|NCT00499863|B3|Baseline|Total|Total of all reporting groups
1125840|NCT00499863|B2|Baseline|Placebo (PTS)|Placebo Transdermal System
1125841|NCT00499863|B1|Baseline|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
1125842|NCT00499863|P2|Participant Flow|Placebo (PTS)|Placebo Transdermal System
1125843|NCT00499863|P1|Participant Flow|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
1125844|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
1125845|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
1125846|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
1125847|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
1125848|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
1125849|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
1125850|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
1125851|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
1125852|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
1125853|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
1125854|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
1125855|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
1125856|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
1125858|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
1125867|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
1125868|NCT00499863|E2|Reported Event|Placebo (PTS)|Placebo Transdermal System
1125869|NCT00499863|E1|Reported Event|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
1125870|NCT00499694|B1|Baseline|Bevacizumab and Satraplatin|"Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days~bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days"
1125921|NCT00499590|O2|Outcome|Bevasiranib 8 Weeks|"Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
1125871|NCT00499694|P1|Participant Flow|Bevacizumab and Satraplatin|"Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days~bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days"
1125872|NCT00499694|O1|Outcome|Bevacizumab and Satraplatin|"Bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) Bevacizumab: 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~Satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days"
1125873|NCT00499694|E1|Reported Event|Bevacizumab and Satraplatin|"Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days~bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days"
1125874|NCT00499681|B3|Baseline|Total|Total of all reporting groups
1125875|NCT00499681|B2|Baseline|Placebo + Letrozole, Then Lapatinib + Letrozole|Part I: some participants received Placebo + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional. FDG-PET/CT scan. Part II: participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks
1125876|NCT00499681|B1|Baseline|Lapatinib + Letrozole, Then Lapatinib + Letrozole|Part I: Some participants received Lapatinib 1500mg + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional FDG-PET/CT scan. Part II, participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks.
1125877|NCT00499681|P2|Participant Flow|Placebo + Letrozole, Then Lapatinib + Letrozole|Part I: some participants received Placebo + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional. FDG-PET/CT scan. Part II: participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks
1125878|NCT00499681|P1|Participant Flow|Lapatinib + Letrozole, Then Lapatinib + Letrozole|Part I: Some participants received Lapatinib 1500mg + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional FDG-PET/CT scan. Part II, participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks.
1125879|NCT00499681|O2|Outcome|Part 1: Letrozole Plus Placebo Part II Letrozole Plus Laptinab|Participants received 2 weeks treatment with letrozole with a placebo and 14 weeks treatment with letrozole and lapatinib
1125880|NCT00499681|O1|Outcome|Part I and Part II Letrozole Plus Laptinab|Participants received 2 weeks treatment with letrozole with lapatinib and 14 weeks treatment with letrozole and lapatinib
1125881|NCT00499681|E2|Reported Event|Placebo + Letrozole, Then Lapatinib + Letrozole|Part I: some participants received Placebo + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional. FDG-PET/CT scan. Part II: participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks
1125882|NCT00499681|E1|Reported Event|Lapatinib + Letrozole, Then Lapatinib + Letrozole|Part I: Some participants received Lapatinib 1500mg + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional FDG-PET/CT scan. Part II, participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks.
1125883|NCT00499655|B3|Baseline|Total|Total of all reporting groups
1125884|NCT00499655|B2|Baseline|Erlotinib\Celecoxib|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28.~erlotinib hydrochloride: Given orally~celecoxib: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
1125885|NCT00499655|B1|Baseline|Erlotinib\Placebo|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.~erlotinib hydrochloride: Given orally~placebo: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
1125886|NCT00499655|P2|Participant Flow|Erlotinib\Celecoxib|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28.~erlotinib hydrochloride: Given orally~celecoxib: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
1125887|NCT00499655|P1|Participant Flow|Erlotinib\Placebo|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.~erlotinib hydrochloride: Given orally~placebo: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
1125888|NCT00499655|O2|Outcome|Erlotinib\Celecoxib|"Patients receive 150 mg oforal erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28.~erlotinib hydrochloride: Given orally~celecoxib: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
1125889|NCT00499655|O1|Outcome|Erlotinib\Placebo|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.~erlotinib hydrochloride: Given orally~placebo: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
1125922|NCT00499590|O1|Outcome|Lucentis|"Lucentis® (0.5mg) every 4 weeks.~ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks."
1127827|NCT00493012|B2|Baseline|Placebo Comparator|A daily placebo oil is given for year
1125890|NCT00499655|O2|Outcome|Erlotinib\Celecoxib|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28.~erlotinib hydrochloride: Given orally~celecoxib: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
1125891|NCT00499655|O1|Outcome|Erlotinib\Placebo|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.~erlotinib hydrochloride: Given orally~placebo: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
1125892|NCT00499655|O2|Outcome|Erlotinib\Celecoxib|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28.~erlotinib hydrochloride: Given orally~celecoxib: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
1125893|NCT00499655|O1|Outcome|Erlotinib\Placebo|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.~erlotinib hydrochloride: Given orally~placebo: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
1125894|NCT00499655|O2|Outcome|Erlotinib\Celecoxib|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28.~erlotinib hydrochloride: Given orally~celecoxib: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
1125895|NCT00499655|O1|Outcome|Erlotinib\Placebo|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.~erlotinib hydrochloride: Given orally~placebo: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
1125896|NCT00499655|O2|Outcome|Erlotinib\Celecoxib|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28.~erlotinib hydrochloride: Given orally~celecoxib: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
1125897|NCT00499655|O1|Outcome|Erlotinib\Placebo|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.~erlotinib hydrochloride: Given orally~placebo: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
1125898|NCT00499655|E2|Reported Event|Erlotinib\Celecoxib|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28.~erlotinib hydrochloride: Given orally~celecoxib: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
1125899|NCT00499655|E1|Reported Event|Erlotinib\Placebo|"Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.~erlotinib hydrochloride: Given orally~placebo: Given orally~laboratory biomarker analysis: Correlative studies~immunohistochemistry staining method: Correlative studies~fluorescence in situ hybridization: Correlative studies~mutation analysis: Correlative studies~protein expression analysis: Correlative studies~gene expression analysis: Correlative studies"
1125900|NCT00499603|B3|Baseline|Total|Total of all reporting groups
1125901|NCT00499603|B2|Baseline|Paclitaxel + RAD001 + FEC|"Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~RAD001 : 30 mg by mouth weekly on Days 1, 8, & 15 for 12 cycles.~Cyclophosphamide : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
1125902|NCT00499603|B1|Baseline|Paclitaxel + FEC|"Paclitaxel 80 mg/m^2 intravenously (IV) on day 1(+/- 2 days) of each week, followed by four cycles of combination 5-Fluorouracil at 500 mg/m^2, Epirubicin at 100 mg/m^2 and Cyclophosphamide at 500 mg/m^2 (FEC) on day 1 every 3 weeks (+/- 7 days).~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~Cyclophosphamide : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
1125903|NCT00499603|P2|Participant Flow|Paclitaxel + RAD001 + FEC|"Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~RAD001 : 30 mg by mouth weekly on Days 1, 8, & 15 for 12 cycles.~Cyclophosphamide: 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
1125923|NCT00499590|O3|Outcome|Bevasiranib 12 Weeks|"Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
1126159|NCT00497770|E2|Reported Event|African American|African American participants receiving pemetrexed for 2nd line NSCLC
1125904|NCT00499603|P1|Participant Flow|Paclitaxel + FEC|"Paclitaxel 80 mg/m^2 intravenously (IV) on day 1(+/- 2 days) of each week, followed by four cycles of combination 5-Fluorouracil at 500 mg/m^2, Epirubicin at 100 mg/m^2 and Cyclophosphamide at 500 mg/m^2 (FEC) on day 1 every 3 weeks (+/- 7 days).~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~Cyclophosphamide: 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
1125905|NCT00499603|O2|Outcome|Paclitaxel + RAD001 + FEC|"Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~RAD001 : 30 mg by mouth weekly on Days 1, 8, & 15 for 12 cycles.~Cyclophosphamide: 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
1125906|NCT00499603|O1|Outcome|Paclitaxel + FEC|"Paclitaxel 80 mg/m^2 intravenously (IV) on day 1(+/- 2 days) of each week, followed by four cycles of combination 5-Fluorouracil at 500 mg/m^2, Epirubicin at 100 mg/m^2 and Cyclophosphamide at 500 mg/m^2 (FEC) on day 1 every 3 weeks (+/- 7 days).~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~Cyclophosphamide: 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
1125907|NCT00499603|O2|Outcome|Paclitaxel + RAD001 + FEC|"Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~RAD001 : 30 mg by mouth weekly on Days 1, 8, & 15 for 12 cycles.~Cyclophosphamide: 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
1125908|NCT00499603|O1|Outcome|Paclitaxel + FEC|"Paclitaxel 80 mg/m^2 intravenously (IV) on day 1(+/- 2 days) of each week, followed by four cycles of combination 5-Fluorouracil at 500 mg/m^2, Epirubicin at 100 mg/m^2 and Cyclophosphamide at 500 mg/m^2 (FEC) on day 1 every 3 weeks (+/- 7 days).~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~Cyclophosphamide: 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
1125909|NCT00499603|O2|Outcome|Paclitaxel + RAD001 + FEC|"Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~RAD001 : 30 mg by mouth weekly on Days 1, 8, & 15 for 12 cycles.~Cyclophosphamide : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
1125910|NCT00499603|O1|Outcome|Paclitaxel + FEC|"Paclitaxel 80 mg/m^2 intravenously (IV) on day 1(+/- 2 days) of each week, followed by four cycles of combination 5-Fluorouracil at 500 mg/m^2, Epirubicin at 100 mg/m^2 and Cyclophosphamide at 500 mg/m^2 (FEC) on day 1 every 3 weeks (+/- 7 days).~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~Cyclophosphamide : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
1125911|NCT00499603|E2|Reported Event|Paclitaxel + RAD001 + FEC|"Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~RAD001 : 30 mg by mouth weekly on Days 1, 8, & 15 for 12 cycles.~Cyclophosphamide : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
1125912|NCT00499603|E1|Reported Event|Paclitaxel + FEC|"Paclitaxel 80 mg/m^2 intravenously (IV) on day 1(+/- 2 days) of each week, followed by four cycles of combination 5-Fluorouracil at 500 mg/m^2, Epirubicin at 100 mg/m^2 and Cyclophosphamide at 500 mg/m^2 (FEC) on day 1 every 3 weeks (+/- 7 days).~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~Cyclophosphamide : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
1125913|NCT00499590|B4|Baseline|Total|Total of all reporting groups
1125914|NCT00499590|B3|Baseline|Bevasiranib 12 Weeks|"Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
1125915|NCT00499590|B2|Baseline|Bevasiranib 8 Weeks|"Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
1125916|NCT00499590|B1|Baseline|Lucentis|"Lucentis® (0.5mg) every 4 weeks.~ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks."
1125917|NCT00499590|P3|Participant Flow|Bevasiranib 12 Weeks|"Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
1125918|NCT00499590|P2|Participant Flow|Bevasiranib 8 Weeks|"Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
1125919|NCT00499590|P1|Participant Flow|Lucentis®|"Lucentis® (0.5mg) every 4 weeks.~ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks."
1125920|NCT00499590|O3|Outcome|Bevasiranib 12 Weeks|"Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
1125924|NCT00499590|O2|Outcome|Bevasiranib 8 Weeks|"Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
1125925|NCT00499590|O1|Outcome|Lucentis®|"Lucentis® (0.5mg) every 4 weeks.~ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks."
1125926|NCT00499590|E3|Reported Event|Bevasiranib 12 Weeks|"Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
1125927|NCT00499590|E2|Reported Event|Bevasiranib 8 Weeks|"Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
1125928|NCT00499590|E1|Reported Event|Lucentis|"Lucentis® (0.5mg) every 4 weeks.~ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks."
1125929|NCT00499486|B1|Baseline|Sirolimus|adencarcinoma refractory to gemcitibine
1125930|NCT00499486|P1|Participant Flow|Sirolimus|Patients with advanced pancreatic adenocarcinoma refractory to gemcitibine received Sirolimus at a single oral flat dose of 5 mg. per day. A treatment cycle was 28 days.
1125931|NCT00499486|O1|Outcome|One Group|Patients with advanced pancreatic adenocarcinoma refractory to gemcitabine
1125932|NCT00499486|O1|Outcome|One Group|Patients with advanced pancreatic adenocarcinoma refractory to gemcitabine
1125933|NCT00499486|O1|Outcome|One Group|Patients with advanced pancreatic adenocarcinoma refractory to gemcitabine
1125934|NCT00499486|E1|Reported Event|Sirolimus|Treatment with rapamycin will begin on Day 1 at a single flat dose level of 5 mg/day. Rapamycin will be administered continuously without interruption through all cycles in an outpatient setting. Each cycle will last 28 days.
1125935|NCT00499473|B3|Baseline|Total|Total of all reporting groups
1125936|NCT00499473|B2|Baseline|Stratum 2: Patients on EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
1125937|NCT00499473|B1|Baseline|Stratum I: Patients Not on EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
1125938|NCT00499473|P2|Participant Flow|Stratum 2: EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
1125939|NCT00499473|P1|Participant Flow|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
1125940|NCT00499473|O2|Outcome|Stratum 2: EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
1125941|NCT00499473|O1|Outcome|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
1125942|NCT00499473|O2|Outcome|Stratum 2: EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
1125943|NCT00499473|O1|Outcome|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
1125944|NCT00499473|O2|Outcome|Stratum 2: EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
1125945|NCT00499473|O1|Outcome|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
1125946|NCT00499473|O2|Outcome|Stratum 2: EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
1125947|NCT00499473|O1|Outcome|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
1125948|NCT00499473|O2|Outcome|Stratum 2: EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
1125949|NCT00499473|O1|Outcome|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
1125950|NCT00499473|O2|Outcome|Stratum 2: EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
1125951|NCT00499473|O1|Outcome|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
1125952|NCT00499473|E2|Reported Event|Stratum 2: EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib. In addition to EIAC (Enzyme-inducing anticonvulsant)
1125953|NCT00499473|E1|Reported Event|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
1125954|NCT00499460|B3|Baseline|Total|Total of all reporting groups
1125955|NCT00499460|B2|Baseline|Placebo First, Then Garlic|Two 30-day treatment periods separated by a washout of at least 4 weeks. In Period 1, participants receive oral placebo tablet twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29. In Period 2, participants receive oral garlic powder (Nature's Way Garlicin tablet) twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29.
1125956|NCT00499460|B1|Baseline|Garlic First, Then Placebo|Two 30-day treatment periods separated by a washout of at least 4 weeks. In Period 1, participants receive oral garlic powder (Nature's Way Garlicin tablet) twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29. In Period 2, participants receive oral placebo tablet twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29.
1125957|NCT00499460|P2|Participant Flow|Placebo First, Then Garlic|Two 30-day treatment periods separated by a washout of at least 4 weeks. In Period 1, participants receive oral placebo tablet twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29. In Period 2, participants receive oral garlic powder (Nature's Way Garlicin tablet) twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29.
1125958|NCT00499460|P1|Participant Flow|Garlic First, Then Placebo|Two 30-day treatment periods separated by a washout of at least 4 weeks. In Period 1, participants receive oral garlic powder (Nature's Way Garlicin tablet) twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29. In Period 2, participants receive oral placebo tablet twice daily on days 1-30, and undergo testings with oxycodone on day 28 and a combination of oral midazolam and digoxin on day 29.
1125959|NCT00499460|O2|Outcome|Placebo|Mean and standard deviation of oral digoxin AUC following placebo treatment were calculated by pooling data from the placebo treatment period in each assigned arm
1125960|NCT00499460|O1|Outcome|Garlic|Mean and standard deviation of oral digoxin AUC following garlic powder treatment were calculated by pooling data from the active treatment period in each assigned arm
1125961|NCT00499460|O2|Outcome|Placebo|Mean and standard deviation of oral midazolam AUC following placebo treatment were calculated by pooling data from the placebo treatment period in each assigned arm
1125962|NCT00499460|O1|Outcome|Garlic|Mean and standard deviation of oral midazolam AUC following garlic powder treatment were calculated by pooling data from the active treatment period in each assigned arm
1125963|NCT00499460|O2|Outcome|Placebo|Mean and standard deviation of CASE Total Score following placebo treatment were calculated by pooling data from the placebo treatment period in each assigned arm
1125964|NCT00499460|O1|Outcome|Garlic|Mean and standard deviation of CASE Total Score following garlic powder treatment were calculated by pooling data from the active treatment period in each assigned arm
1125965|NCT00499460|O2|Outcome|Placebo|Mean and standard deviation of SSE Total Score following placebo treatment were calculated by pooling data from the placebo treatment period in each assigned arm
1125966|NCT00499460|O1|Outcome|Garlic|Mean and standard deviation of SSE Total Score following garlic powder treatment were calculated by pooling data from the active treatment period in each assigned arm
1125967|NCT00499460|O2|Outcome|Placebo|Mean and standard deviation of Cold Pressor Test Tolerance AUC following placebo treatment were calculated by pooling data from the placebo treatment period in each assigned arm
1125968|NCT00499460|O1|Outcome|Garlic|Mean and standard deviation of Cold Pressor Test Tolerance AUC following garlic powder treatment were calculated by pooling data from the active treatment period in each assigned arm
1125969|NCT00499460|O2|Outcome|Placebo|Mean and standard deviation of oxycodone oral clearance following placebo treatment were calculated by pooling data from the placebo treatment period in each assigned arm
1125970|NCT00499460|O1|Outcome|Garlic|Mean and standard deviation of oxycodone oral clearance following garlic powder treatment were calculated by pooling data from the active treatment period in each assigned arm
1125971|NCT00499460|E2|Reported Event|Placebo|Data for all subjects during their placebo treatment period in both arms were pooled.
1125972|NCT00499460|E1|Reported Event|Garlic|Data for all subjects during their active garlic treatment period in both arms were pooled.
1125973|NCT00499447|B1|Baseline|Radiofrequency Ablation Combined With External|
1125974|NCT00499447|P1|Participant Flow|Radiofrequency Ablation Combined With External|
1125975|NCT00499447|O1|Outcome|Radiofrequency Ablation Combined With External|
1125976|NCT00499447|E1|Reported Event|Radiofrequency Ablation Combined With External|
1125977|NCT00499408|B1|Baseline|Vitamin D and Soy Supplementation|oral supplementation with both 2,000 international units per day of vitamin D (cholecalciferol) and soy (160 milligrams per day soy isoflavones)
1125978|NCT00499408|P1|Participant Flow|Vitamin D and Soy Supplementation|oral supplementation with both 2,000 international units per day of vitamin D (cholecalciferol) and soy (160 milligrams per day soy isoflavones)
1125979|NCT00499408|O1|Outcome|Vitamin D and Soy Supplementation|oral supplementation with both 2,000 international units per day of vitamin D (cholecalciferol) and soy (160 milligrams per day soy isoflavones)
1125980|NCT00499408|E1|Reported Event|Vitamin D and Soy Supplementation|oral supplementation with both 2,000 international units per day of vitamin D (cholecalciferol) and soy (160 milligrams per day soy isoflavones)
1125981|NCT00499369|B6|Baseline|Total|Total of all reporting groups
1125982|NCT00499369|B5|Baseline|Cohort II: Chemotherapy + Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1125983|NCT00499369|B4|Baseline|Cohort II: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1125984|NCT00499369|B3|Baseline|Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1126160|NCT00497770|E1|Reported Event|Caucasian|Caucasian participants receiving pemetrexed for second (2nd) line non-small cell lung cancer (NSCLC)
1126161|NCT00498706|B3|Baseline|Total|Total of all reporting groups
1125985|NCT00499369|B2|Baseline|Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1125986|NCT00499369|B1|Baseline|Cohort I: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1125987|NCT00499369|P5|Participant Flow|Cohort II: Chemotherapy + Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1125988|NCT00499369|P4|Participant Flow|Cohort II: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1125989|NCT00499369|P3|Participant Flow|Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1125990|NCT00499369|P2|Participant Flow|Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1125991|NCT00499369|P1|Participant Flow|Cohort I: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1125992|NCT00499369|O5|Outcome|Cohort II: Chemotherapy + Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1125993|NCT00499369|O4|Outcome|Cohort II: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1125994|NCT00499369|O3|Outcome|Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1125995|NCT00499369|O2|Outcome|Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1125996|NCT00499369|O1|Outcome|Cohort I: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1125997|NCT00499369|O5|Outcome|Cohort II: Chemotherapy + Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1125998|NCT00499369|O4|Outcome|Cohort II: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1125999|NCT00499369|O3|Outcome|Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1126000|NCT00499369|O2|Outcome|Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1126001|NCT00499369|O1|Outcome|Cohort I: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1126002|NCT00499369|O5|Outcome|Cohort II: Chemotherapy + Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1126003|NCT00499369|O4|Outcome|Cohort II: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1126004|NCT00499369|O3|Outcome|Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1126005|NCT00499369|O2|Outcome|Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1126006|NCT00499369|O1|Outcome|Cohort I: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1126007|NCT00499369|O5|Outcome|Cohort II: Chemotherapy + Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1126008|NCT00499369|O4|Outcome|Cohort II: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1126009|NCT00499369|O3|Outcome|Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1126010|NCT00499369|O2|Outcome|Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1126011|NCT00499369|O1|Outcome|Cohort I: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1126013|NCT00499369|E4|Reported Event|Cohort II: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1126014|NCT00499369|E3|Reported Event|Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1126015|NCT00499369|E2|Reported Event|Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1126016|NCT00499369|E1|Reported Event|Cohort I: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
1126017|NCT00499343|B3|Baseline|Total|Total of all reporting groups
1126018|NCT00499343|B2|Baseline|Rituximab + Ifosfamide + Etoposide + 1 Growth Factor|Growth Factor = granulocyte-colony stimulating factor (G-CSF)
1126019|NCT00499343|B1|Baseline|Rituximab + Ifosfamide + Etoposide + 2 Growth Factors|Growth Factors = granulocyte-colony stimulating factor (G-CSF) + granulocyte macrophage-colony stimulating factor (GM-CSF)
1126020|NCT00499343|P2|Participant Flow|Rituximab + Ifosfamide + Etoposide + 1 Growth Factor|Growth Factor = granulocyte-colony stimulating factor (G-CSF)
1126021|NCT00499343|P1|Participant Flow|Rituximab + Ifosfamide + Etoposide + 2 Growth Factors|Growth Factors = granulocyte-colony stimulating factor (G-CSF) + granulocyte macrophage-colony stimulating factor (GM-CSF)
1126022|NCT00499343|O2|Outcome|Rituximab + Ifosfamide + Etoposide + 1 Growth Factor|Growth Factor = granulocyte-colony stimulating factor (G-CSF)
1126023|NCT00499343|O1|Outcome|Rituximab + Ifosfamide + Etoposide + 2 Growth Factors|Growth Factors = granulocyte-colony stimulating factor (G-CSF) + granulocyte macrophage-colony stimulating factor (GM-CSF)
1126024|NCT00499343|E2|Reported Event|Rituximab + Ifosfamide + Etoposide + 1 Growth Factor|Growth Factor = granulocyte-colony stimulating factor (G-CSF)
1126025|NCT00499343|E1|Reported Event|Rituximab + Ifosfamide + Etoposide + 2 Growth Factors|Growth Factors = granulocyte-colony stimulating factor (G-CSF) + granulocyte macrophage-colony stimulating factor (GM-CSF)
1126026|NCT00499252|B1|Baseline|Abraxane®|Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
1126027|NCT00499252|P1|Participant Flow|Abraxane®|Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
1126028|NCT00499252|O1|Outcome|Abraxane®|Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
1126029|NCT00499252|O1|Outcome|Abraxane®|Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
1126030|NCT00499252|O1|Outcome|Abraxane®|Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
1126031|NCT00499252|E1|Reported Event|Abraxane®|Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
1126032|NCT00499122|B1|Baseline|NOV-002 and Chemotherapy|"NOV-002:~Cycle 1, Day -1 only: 60 mg intravenously (IV) x 2, 3 hours (+/- 30 minutes) apart~Cycles 1 - 8, Day 1: 60 mg IV, 1 hour (+/- 30 minutes) prior to chemotherapy administration~Cycle 1 - 8, Days 2 - 21: 60 mg subcutaneous injections~Cyclophosphamide: 600 mg/m2 IV, Cycles 1 - 4, Day 1~Doxorubicin: 60 mg/m2 IV, Cycles 1 - 4, Day 1~Docetaxel: 100 mg/m2 IV, Cycles 5 - 8, Day 1"
1126033|NCT00499122|P1|Participant Flow|NOV-002 and Chemotherapy|"NOV-002:~Cycle 1, Day -1 only: 60 mg intravenously (IV) x 2, 3 hours (+/- 30 minutes) apart~Cycles 1 - 8, Day 1: 60 mg IV, 1 hour (+/- 30 minutes) prior to chemotherapy administration~Cycle 1 - 8, Days 2 - 21: 60 mg subcutaneous injections~Cyclophosphamide: 600 mg/m2 IV, Cycles 1 - 4, Day 1~Doxorubicin: 60 mg/m2 IV, Cycles 1 - 4, Day 1~Docetaxel: 100 mg/m2 IV, Cycles 5 - 8, Day 1"
1126034|NCT00499122|O1|Outcome|NOV-002 and Chemotherapy|"NOV-002:~Cycle 1, Day -1 only: 60 mg intravenously (IV) x 2, 3 hours (+/- 30 minutes) apart~Cycles 1 - 8, Day 1: 60 mg IV, 1 hour (+/- 30 minutes) prior to chemotherapy administration~Cycle 1 - 8, Days 2 - 21: 60 mg subcutaneous injections~Cyclophosphamide: 600 mg/m2 IV, Cycles 1 - 4, Day 1~Doxorubicin: 60 mg/m2 IV, Cycles 1 - 4, Day 1~Docetaxel: 100 mg/m2 IV, Cycles 5 - 8, Day 1~Cyclophosphamide~Docetaxel~Doxorubicin~NOV 002"
1126035|NCT00499122|O1|Outcome|NOV-002 and Chemotherapy|"NOV-002:~Cycle 1, Day -1 only: 60 mg intravenously (IV) x 2, 3 hours (+/- 30 minutes) apart~Cycles 1 - 8, Day 1: 60 mg IV, 1 hour (+/- 30 minutes) prior to chemotherapy administration~Cycle 1 - 8, Days 2 - 21: 60 mg subcutaneous injections~Cyclophosphamide: 600 mg/m2 IV, Cycles 1 - 4, Day 1~Doxorubicin: 60 mg/m2 IV, Cycles 1 - 4, Day 1~Docetaxel: 100 mg/m2 IV, Cycles 5 - 8, Day 1"
1126036|NCT00499122|E1|Reported Event|NOV-002 and Chemotherapy|"NOV-002:~Cycle 1, Day -1 only: 60 mg intravenously (IV) x 2, 3 hours (+/- 30 minutes) apart~Cycles 1 - 8, Day 1: 60 mg IV, 1 hour (+/- 30 minutes) prior to chemotherapy administration~Cycle 1 - 8, Days 2 - 21: 60 mg subcutaneous injections~Cyclophosphamide: 600 mg/m2 IV, Cycles 1 - 4, Day 1~Doxorubicin: 60 mg/m2 IV, Cycles 1 - 4, Day 1~Docetaxel: 100 mg/m2 IV, Cycles 5 - 8, Day 1"
1126037|NCT00499109|B3|Baseline|Total|Total of all reporting groups
1126038|NCT00499109|B2|Baseline|C. Standard of Care Control Arm|"Control Arm C: Gemcitabine and Carboplatin (GCb).~All patients in arm C were treated with GCb regardless of gene expression levels. Patients received up to 6 cycles, and no maintenance therapy was allowed."
1126039|NCT00499109|B1|Baseline|E. Dual Agent Chemotherapy|"Experimental Arm E.~Patients received treatment according to gene expression strata with four doublet regimens.~Low ERCC1 and Low RRM1 Group - Gemcitabine (G) and Carboplatin (Cb): GCb Group.~Low RRM1 and High ERCC1 Group - Gemcitabine (G) and Docetaxel (D): GD Group.~High RRM1 and Low ERCC1 Group - Docetaxel (D) and Carboplatin (Cb): DCb Group.~High ERCC1 and High RRM1 Group - Vinorelbine (V) and Docetaxel (D): DV Group."
1126040|NCT00499109|P2|Participant Flow|C. Standard of Care Control Arm|"Control Arm C: Gemcitabine and Carboplatin (GCb).~All patients in arm C were treated with GCb regardless of gene expression levels. Patients received up to 6 cycles, and no maintenance therapy was allowed."
1133732|NCT00477269|O2|Outcome|Placebo|Placebo
1126041|NCT00499109|P1|Participant Flow|E. Dual Agent Chemotherapy|"Experimental Arm E.~Patients received treatment according to gene expression strata with four doublet regimens.~Low ERCC1 and Low RRM1 Group - Gemcitabine (G) and Carboplatin (Cb): GCb Group.~Low RRM1 and High ERCC1 Group - Gemcitabine (G) and Docetaxel (D): GD Group.~High RRM1 and Low ERCC1 Group - Docetaxel (D) and Carboplatin (Cb): DCb Group.~High ERCC1 and High RRM1 Group - Vinorelbine (V) and Docetaxel (D): DV Group."
1126042|NCT00499109|O2|Outcome|C. Standard of Care Control Arm|"Control Arm C: Gemcitabine and Carboplatin (GCb).~All patients in arm C were treated with GCb regardless of gene expression levels. Patients received up to 6 cycles, and no maintenance therapy was allowed."
1126043|NCT00499109|O1|Outcome|E. Dual Agent Chemotherapy|"Experimental Arm E.~Patients received treatment according to gene expression strata with four doublet regimens.~Low ERCC1 and Low RRM1 Group - Gemcitabine (G) and Carboplatin (Cb): GCb Group.~Low RRM1 and High ERCC1 Group - Gemcitabine (G) and Docetaxel (D): GD Group.~High RRM1 and Low ERCC1 Group - Docetaxel (D) and Carboplatin (Cb): DCb Group.~High ERCC1 and High RRM1 Group - Vinorelbine (V) and Docetaxel (D): DV Group."
1126044|NCT00499109|O2|Outcome|C. Standard of Care Control Arm|"Control Arm C: Gemcitabine and Carboplatin (GCb).~All patients in arm C were treated with GCb regardless of gene expression levels. Patients received up to 6 cycles, and no maintenance therapy was allowed."
1126045|NCT00499109|O1|Outcome|E. Dual Agent Chemotherapy|"Experimental Arm E.~Patients received treatment according to gene expression strata with four doublet regimens.~Low ERCC1 and Low RRM1 Group - Gemcitabine (G) and Carboplatin (Cb): GCb Group.~Low RRM1 and High ERCC1 Group - Gemcitabine (G) and Docetaxel (D): GD Group.~High RRM1 and Low ERCC1 Group - Docetaxel (D) and Carboplatin (Cb): DCb Group.~High ERCC1 and High RRM1 Group - Vinorelbine (V) and Docetaxel (D): DV Group."
1126046|NCT00499109|O2|Outcome|C. Standard of Care Control Arm|"Control Arm C: Gemcitabine and Carboplatin (GCb).~All patients in arm C were treated with GCb regardless of gene expression levels. Patients received up to 6 cycles, and no maintenance therapy was allowed."
1126047|NCT00499109|O1|Outcome|E. Dual Agent Chemotherapy|"Experimental Arm E.~Patients received treatment according to gene expression strata with four doublet regimens.~Low ERCC1 and Low RRM1 Group - Gemcitabine (G) and Carboplatin (Cb): GCb Group.~Low RRM1 and High ERCC1 Group - Gemcitabine (G) and Docetaxel (D): GD Group.~High RRM1 and Low ERCC1 Group - Docetaxel (D) and Carboplatin (Cb): DCb Group.~High ERCC1 and High RRM1 Group - Vinorelbine (V) and Docetaxel (D): DV Group."
1126048|NCT00499109|E5|Reported Event|Control: C|Gemcitabine/Carboplatin
1126049|NCT00499109|E4|Reported Event|Experimental: E4|Gemcitabine/Carboplatin
1126050|NCT00499109|E3|Reported Event|Experimental: E3|Gemcitabine/Docetaxel
1126051|NCT00499109|E2|Reported Event|Experimental: E2|Docetaxel/Carboplatin
1126052|NCT00499109|E1|Reported Event|Experimental: E1|Docetaxel/Vinorelbine
1126053|NCT00499096|B3|Baseline|Total|Total of all reporting groups
1126054|NCT00499096|B2|Baseline|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease (CVD) will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
1126055|NCT00499096|B1|Baseline|Chronic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease (CVD); group will receive self-management group sessions, followed by phone contacts by the Care Manager.~Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
1126056|NCT00499096|P2|Participant Flow|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
1126057|NCT00499096|P1|Participant Flow|Chronic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager.~Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
1126058|NCT00499096|O2|Outcome|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
1126059|NCT00499096|O1|Outcome|Chronic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager.~Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
1126060|NCT00499096|O2|Outcome|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
1126091|NCT00498927|O1|Outcome|Temozolomide|Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
1126061|NCT00499096|O1|Outcome|Chonic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager.~Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
1126062|NCT00499096|O2|Outcome|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
1126063|NCT00499096|O1|Outcome|Chonic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager.~Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
1126064|NCT00499096|O2|Outcome|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
1126065|NCT00499096|O1|Outcome|Chronic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager. This is the chronic care model for bipolar disorder~Chronic care model for Bipolar Disorder: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
1126066|NCT00499096|O2|Outcome|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
1126067|NCT00499096|O1|Outcome|Chronic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager.~Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
1126068|NCT00499096|O2|Outcome|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
1126069|NCT00499096|O1|Outcome|Chronic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager. This is the chronic care model for bipolar disorder~Chronic care model for Bipolar Disorder: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
1126070|NCT00499096|O2|Outcome|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
1126071|NCT00499096|O1|Outcome|Chronic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager.~Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
1126072|NCT00499096|E2|Reported Event|Arm 2|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
1126090|NCT00498927|O1|Outcome|Temozolomide|Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
1126149|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
1126153|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
1126154|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
1128793|NCT00490035|B1|Baseline|Placebo|Matching Placebo tablets administered twice a day
1126073|NCT00499096|E1|Reported Event|Arm 1|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager.~Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
1126074|NCT00499031|B1|Baseline|Treatment (Cetuximab)|Day 1: 400 mg/m2 loading dose of cetuximab IV over 120 minutes; Day 8 and weekly thereafter: 250 mg/m2 cetuximab IV over 60 minutes (one cycle = four weeks) until disease progression or adverse effects prohibit further therapy
1126075|NCT00499031|P1|Participant Flow|Treatment (Cetuximab)|Day 1: 400 mg/m2 loading dose of cetuximab IV over 120 minutes; Day 8 and weekly thereafter: 250 mg/m2 cetuximab IV over 60 minutes (one cycle = four weeks) until disease progression or adverse effects prohibit further therapy
1126076|NCT00499031|O1|Outcome|Treatment (Cetuximab)|Day 1: 400 mg/m2 loading dose of cetuximab IV over 120 minutes; Day 8 and weekly thereafter: 250 mg/m2 cetuximab IV over 60 minutes (one cycle = four weeks) until disease progression or adverse effects prohibit further therapy
1126077|NCT00499031|O1|Outcome|Treatment (Cetuximab)|Day 1: 400 mg/m2 loading dose of cetuximab IV over 120 minutes; Day 8 and weekly thereafter: 250 mg/m2 cetuximab IV over 60 minutes (one cycle = four weeks) until disease progression or adverse effects prohibit further therapy
1126078|NCT00499031|E1|Reported Event|Treatment (Cetuximab)|Day 1: 400 mg/m2 loading dose of cetuximab IV over 120 minutes; Day 8 and weekly thereafter: 250 mg/m2 cetuximab IV over 60 minutes (one cycle = four weeks) until disease progression or adverse effects prohibit further therapy
1126079|NCT00498940|B3|Baseline|Total|Total of all reporting groups
1126080|NCT00498940|B2|Baseline|Standard of Care|"No continuous pacing occurred about surgery. Patients underwent optimization testing.~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III."
1126081|NCT00498940|B1|Baseline|Biventricular Pacing|"After weaning from bypass, patients received temporary biventricular pacing for 24 hours. Values obtained from optimization testing determined pacemaker settings (AVD, VVD, heart rate).~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III.~Temporary Biventricular Pacing: Continuous temporary biventricular pacing for 24 hours at a heart rate of 90 bpm or 10 bpm above intrinsic heart rate."
1126082|NCT00498940|P2|Participant Flow|Standard of Care|"No post operative pacing is to occur. Patients will undergo optimization testing.~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and heart rate were optimized after weaning off bypass (phase I), after sternal closure (phase II), and 12 to 24 hours (phase III) after bypass."
1126083|NCT00498940|P1|Participant Flow|Biventricular Pacing|"After weaning from bypass, patients will receive temporary biventricular pacing for 24 hours. Values obtained from optimization testing will determine pacemaker settings (AVD, VVD, heart rate).~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and heart rate were optimized after weaning off bypass (phase I), after sternal closure (phase II), and 12 to 24 hours (phase III) after bypass.~Temporary Biventricular Pacing: Continuous temporary biventricular pacing for 24 hours."
1126084|NCT00498940|O2|Outcome|Standard of Care|"No continuous pacing occurred about surgery. Patients underwent optimization testing.~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III."
1126085|NCT00498940|O1|Outcome|Biventricular Pacing|"After weaning from bypass, patients received temporary biventricular pacing for 24 hours. Values obtained from optimization testing determined pacemaker settings (AVD, VVD, heart rate).~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III.~Temporary Biventricular Pacing: Continuous temporary biventricular pacing for 24 hours at a heart rate of 90 bpm or 10 bpm above intrinsic heart rate."
1126086|NCT00498940|E2|Reported Event|Standard of Care|"No continuous pacing occurred about surgery. Patients underwent optimization testing.~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III."
1126087|NCT00498940|E1|Reported Event|Biventricular Pacing|"After weaning from bypass, patients received temporary biventricular pacing for 24 hours. Values obtained from optimization testing determined pacemaker settings (AVD, VVD, heart rate).~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III.~Temporary Biventricular Pacing: Continuous temporary biventricular pacing for 24 hours at a heart rate of 90 bpm or 10 bpm above intrinsic heart rate."
1126088|NCT00498927|B1|Baseline|Temozolomide|Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
1126089|NCT00498927|P1|Participant Flow|Temozolomide|Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
1126148|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for second (2nd) line non-small cell lung cancer (NSCLC)
1126092|NCT00498927|E1|Reported Event|Temozolomide|Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
1126093|NCT00498797|B3|Baseline|Total|Total of all reporting groups
1126094|NCT00498797|B2|Baseline|Placebo|docetaxel/prednisolone/placebo
1126095|NCT00498797|B1|Baseline|Vandetanib|docetaxel/prednisolone/vandetanib
1126096|NCT00498797|P2|Participant Flow|Placebo|docetaxel/prednisolone/placebo
1126097|NCT00498797|P1|Participant Flow|Vandetanib|docetaxel/prednisolone/vandetanib
1126098|NCT00498797|O2|Outcome|Placebo|docetaxel/prednisolone/placebo
1126099|NCT00498797|O1|Outcome|Vandetanib|docetaxel/prednisolone/vandetanib
1126100|NCT00498797|O2|Outcome|Placebo|docetaxel/prednisolone/placebo
1126101|NCT00498797|O1|Outcome|Vandetanib|docetaxel/prednisolone/vandetanib
1126102|NCT00498797|E2|Reported Event|Placebo|docetaxel/prednisolone/placebo
1126103|NCT00498797|E1|Reported Event|Vandetanib|docetaxel/prednisolone/vandetanib
1126104|NCT00497770|B5|Baseline|Total|Total of all reporting groups
1126105|NCT00497770|B4|Baseline|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
1126106|NCT00497770|B3|Baseline|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
1126107|NCT00497770|B2|Baseline|African American|African American participants receiving pemetrexed for 2nd line NSCLC
1126108|NCT00497770|B1|Baseline|Caucasian|Caucasian participants receiving pemetrexed for second (2nd) line non-small cell lung cancer (NSCLC)
1126109|NCT00497770|P4|Participant Flow|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
1126110|NCT00497770|P3|Participant Flow|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
1126111|NCT00497770|P2|Participant Flow|African American|African American participants receiving pemetrexed for 2nd line NSCLC
1126112|NCT00497770|P1|Participant Flow|Caucasian|Caucasian participants receiving pemetrexed for second (2nd) line non-small cell lung cancer (NSCLC)
1126113|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
1126114|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
1126115|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
1126116|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
1126117|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
1126118|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
1126119|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
1126120|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
1126121|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
1126122|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
1126123|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
1126124|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
1126125|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
1126126|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
1126127|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
1126128|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
1126129|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
1126130|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
1126131|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
1126132|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
1126133|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
1126134|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
1126135|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
1126136|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
1126137|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
1126138|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
1126139|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
1126140|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
1126141|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
1126142|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
1126143|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
1126144|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
1126145|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
1126146|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
1126147|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
1126150|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
1126151|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
1126152|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
1126162|NCT00498706|B2|Baseline|Face-to-face CBT|Participants will receive face-to-face cognitive behavioral therapy.
1126163|NCT00498706|B1|Baseline|Telephone-administered CBT|Participants will receive telephone-administered cognitive behavioral therapy.
1126164|NCT00498706|P2|Participant Flow|Face-to-face CBT|Participants will receive face-to-face cognitive behavioral therapy.
1126165|NCT00498706|P1|Participant Flow|Telephone-administered CBT|Participants will receive telephone-administered cognitive behavioral therapy.
1126166|NCT00498706|O2|Outcome|Face-to-face CBT|Participants will receive face-to-face cognitive behavioral therapy.
1126167|NCT00498706|O1|Outcome|Telephone-administered CBT|Participants will receive telephone-administered cognitive behavioral therapy.
1126168|NCT00498706|O2|Outcome|Face-to-face CBT|Participants will receive face-to-face cognitive behavioral therapy.
1126169|NCT00498706|O1|Outcome|Telephone-administered CBT|Participants will receive telephone-administered cognitive behavioral therapy.
1126170|NCT00498706|O2|Outcome|Face-to-face Cognitive Behavioral Therapy|Participants will receive face-to-face cognitive behavioral therapy.
1126171|NCT00498706|O1|Outcome|Telephone-administered Cognitive Behavioral Therapy|Participants will receive telephone-administered cognitive behavioral therapy.
1126172|NCT00498706|O2|Outcome|Face-to-face CBT|Participants will receive face-to-face cognitive behavioral therapy.
1126173|NCT00498706|O1|Outcome|Telephone-administered CBT|Participants will receive telephone-administered cognitive behavioral therapy.
1126174|NCT00498706|E2|Reported Event|Face-to-face CBT|Participants will receive face-to-face cognitive behavioral therapy.
1126175|NCT00498706|E1|Reported Event|Telephone-administered CBT|Participants will receive telephone-administered cognitive behavioral therapy.
1126176|NCT00498628|B3|Baseline|Total|Total of all reporting groups
1126177|NCT00498628|B2|Baseline|Sugar Pill Plus Medical Management|Medical management plus placebo comparator
1126178|NCT00498628|B1|Baseline|Quetiapine Fumerate Plus Medical Management|Quetiapine fumarate - target dose 400mg/day plus medical management
1126179|NCT00498628|P2|Participant Flow|Sugar Pill Plus Medical Management|Medical management plus placebo comparator
1126180|NCT00498628|P1|Participant Flow|Quetiapine Fumerate Plus Medical Management|Quetiapine fumarate - target dose 400mg/day plus medical management
1126181|NCT00498628|O2|Outcome|Sugar Pill Plus Medical Management|Medical management plus placebo comparator
1126182|NCT00498628|O1|Outcome|Quetiapine Fumerate Plus Medical Management|Quetiapine fumarate - target dose 400mg/day plus medical management
1126183|NCT00498628|E2|Reported Event|Sugar Pill Plus Medical Management|Medical management plus placebo comparator
1126184|NCT00498628|E1|Reported Event|Quetiapine Fumerate Plus Medical Management|Quetiapine fumarate - target dose 400mg/day plus medical management
1126185|NCT00498615|B1|Baseline|3 Period Crossover Study ( All Participants)|"This is a single-center, double-blind, placebo-controlled, randomized, 3-period crossover study of oral fasudil (40 mg or 80 mg) or placebo administered 2 hours before a standardized cold challenge.~Men and women between ages 18–80 years with a clinical diagnosis of RP secondary to SSc were eligible for the study."
1126186|NCT00498615|P6|Participant Flow|Sequence 6|Subjects received a single dose of placebo at treatment period 1. At treatment period 2 they will received a single dose of Fasudil 80 mg and at treatment period 3 they received a single dose of Fasudil 40 mg. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods
1126187|NCT00498615|P5|Participant Flow|Sequence 5|Subjects received a single dose of Fasudil 40 mg at treatment period 1. At treatment period 2 they will received a single dose of placebo and at treatment period 3 they received a single dose of Fasudil 80 mg. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods
1126188|NCT00498615|P4|Participant Flow|Sequence 4|Subjects received a single dose of placebo at treatment period 1. At treatment period 2 they will received a single dose of Fasudil 40 mg and at treatment period 3 they received a single dose of Fasudil 80 mg. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods
1126189|NCT00498615|P3|Participant Flow|Sequence 3|Subjects received a single dose of Fasudil 80 mg at treatment period 1. At treatment period 2 they will received a single dose of placebo and at treatment period 3 they received a single dose of Fasudil 40 mg. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods
1126190|NCT00498615|P2|Participant Flow|Sequence 2|Subjects received a single dose of Fasudil 40 mg at treatment period 1. At treatment period 2 they will received a single dose of Fasudil 80 mg and at treatment period 3 they received a single dose of placebo. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods
1126191|NCT00498615|P1|Participant Flow|Sequence 1|Subjects received a single dose of Fasudil 80 mg at treatment period 1. At treatment period 2 they will received a single dose of Fasudil 40 mg and at treatment period 3 they received a single dose of placebo. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods.
1126192|NCT00498615|O3|Outcome|Placebo|"Time to reach 70% of skin temperature after cold challenge done 2 hrs after taking placebo~Fasudil: Each subject will be randomly assigned to 1 of 6 possible treatment sequences (ABC, ACB, BAC, BCA, CAB, and CBA) in a double-blind manner: A- a single oral dose of 2 placebo tablets; B- a single, oral 40 mg Fasudil dose as one 40 mg tablet and 1 placebo tablet; C- a single oral 80 mg dose as two 40 mg Fasudil tablets. Subjects will be randomized at the screening/baseline visit to a specific treatment sequence based upon a computer generated code on a 1:1:1:1:1:1 ratio for the 6 possible treatments. A single dose consisting of the two tablets will be taken after fasting for 10 hours once during each treatment period. A washout interval of at least 72 hours and no more than 7 days will be maintained between treatment periods. Concomitant medications will not be taken during the study session."
1126222|NCT00498602|O4|Outcome|ACC 10 μg|Participants received 10 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126223|NCT00498602|O3|Outcome|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126224|NCT00498602|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126193|NCT00498615|O2|Outcome|40 mg Fasudil|"Time to reach 70% skin temperature after cold challenge done 2 hrs after dosing.~Fasudil: Each subject will be randomly assigned to 1 of 6 possible treatment sequences (ABC, ACB, BAC, BCA, CAB, and CBA) in a double-blind manner: A- a single oral dose of 2 placebo tablets; B- a single, oral 40 mg Fasudil dose as one 40 mg tablet and 1 placebo tablet; C- a single oral 80 mg dose as two 40 mg Fasudil tablets. Subjects will be randomized at the screening/baseline visit to a specific treatment sequence based upon a computer generated code on a 1:1:1:1:1:1 ratio for the 6 possible treatments. A single dose consisting of the two tablets will be taken after fasting for 10 hours once during each treatment period. A washout interval of at least 72 hours and no more than 7 days will be maintained between treatment periods. Concomitant medications will not be taken during the study session."
1126194|NCT00498615|O1|Outcome|Fasudil 80 mg|"Time to recover 70% of baseline skin temperature after cold challenge done 2 hrs after dose.~Fasudil: Each subject will be randomly assigned to 1 of 6 possible treatment sequences (ABC, ACB, BAC, BCA, CAB, and CBA) in a double-blind manner: A- a single oral dose of 2 placebo tablets; B- a single, oral 40 mg Fasudil dose as one 40 mg tablet and 1 placebo tablet; C- a single oral 80 mg dose as two 40 mg Fasudil tablets. Subjects will be randomized at the screening/baseline visit to a specific treatment sequence based upon a computer generated code on a 1:1:1:1:1:1 ratio for the 6 possible treatments. A single dose consisting of the two tablets will be taken after fasting for 10 hours once during each treatment period. A washout interval of at least 72 hours and no more than 7 days will be maintained between treatment periods. Concomitant medications will not be taken during the study session."
1126195|NCT00498615|O3|Outcome|Placebo|In this group participants received placebo 2 hours before cold challenge.
1126196|NCT00498615|O2|Outcome|40 mg Fasudil|In this group participants received 40mg of Fasudil 2 hours before cold challenge
1126197|NCT00498615|O1|Outcome|80 mg Fasudil|"This is a single-center, double-blind, placebo-controlled, randomized, 3-period crossover study of oral fasudil In this arm participants received 80 mg of Fasudil 2 hours before a standardized cold challenge.~Men and women between ages 18–80 years with a clinical diagnosis of Raynauds Phenomenon secondary to Scleroderma were eligible for the study."
1126198|NCT00498615|O3|Outcome|Placebo|participants will receive placebo at 1 of 3 study periods. participants and researchers will not know which is received.
1126199|NCT00498615|O2|Outcome|80 mg Fasudil|participants will receive 80mg of Fasudil at 1 one 3 study periods 2hrs before a cold challenge.
1126200|NCT00498615|O1|Outcome|40 mg Fasudil|This is a single-center, double-blind, placebo-controlled, randomized, 3-period crossover study of oral fasudil 40 mg administered 2 hours before a standardized cold challenge participant and researchers will not know what is received on the testing day.
1126201|NCT00498615|E3|Reported Event|80mg Fasudil|80mg Fasudil was administered 2 hours before a standardized cold challenge.
1126202|NCT00498615|E2|Reported Event|40 mg Fasudil|40 mg Fasudil was administered 2 hours before a standardized cold challenge.
1126203|NCT00498615|E1|Reported Event|Placebo|Placebo was administered 2 hours before a standardized cold challenge.
1126204|NCT00498602|B8|Baseline|Total|Total of all reporting groups
1126205|NCT00498602|B7|Baseline|Phosphate Buffered Saline|Participants received PBS. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126206|NCT00498602|B6|Baseline|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126207|NCT00498602|B5|Baseline|ACC 30 μg|Participants received 30 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126208|NCT00498602|B4|Baseline|ACC 10 μg|Participants received 10 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126209|NCT00498602|B3|Baseline|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126210|NCT00498602|B2|Baseline|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126211|NCT00498602|B1|Baseline|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126212|NCT00498602|P7|Participant Flow|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126213|NCT00498602|P6|Participant Flow|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126214|NCT00498602|P5|Participant Flow|ACC 30 μg|Participants received 30 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126215|NCT00498602|P4|Participant Flow|ACC 10 μg|Participants received 10 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126216|NCT00498602|P3|Participant Flow|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126217|NCT00498602|P2|Participant Flow|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126275|NCT00498433|B3|Baseline|Part 2, Double Blind: Amlodipine|Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
1126218|NCT00498602|P1|Participant Flow|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126219|NCT00498602|O7|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126220|NCT00498602|O6|Outcome|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126221|NCT00498602|O5|Outcome|ACC 30 μg|Participants received 30 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126225|NCT00498602|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126226|NCT00498602|O7|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126227|NCT00498602|O6|Outcome|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126228|NCT00498602|O5|Outcome|ACC 30 μg|Participants received 30 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126229|NCT00498602|O4|Outcome|ACC 10 μg|Participants received 10 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126230|NCT00498602|O3|Outcome|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126231|NCT00498602|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126232|NCT00498602|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126233|NCT00498602|O7|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126234|NCT00498602|O6|Outcome|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126235|NCT00498602|O5|Outcome|ACC 30 μg|Participants received 30 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126236|NCT00498602|O4|Outcome|ACC 10 μg|Participants received 10 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126237|NCT00498602|O3|Outcome|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126238|NCT00498602|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126239|NCT00498602|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126240|NCT00498602|O7|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126241|NCT00498602|O6|Outcome|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126242|NCT00498602|O5|Outcome|ACC 30 μg|Participants received 30 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126243|NCT00498602|O4|Outcome|ACC 10 μg|Participants received 10 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126244|NCT00498602|O3|Outcome|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126245|NCT00498602|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126246|NCT00498602|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126247|NCT00498602|E7|Reported Event|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126248|NCT00498602|E6|Reported Event|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126249|NCT00498602|E5|Reported Event|ACC 30 μg|Participants received 30 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126250|NCT00498602|E4|Reported Event|ACC 10 μg|Participants received 10 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126251|NCT00498602|E3|Reported Event|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126357|NCT00497874|O2|Outcome|Usual Care|Usual primary care
1126252|NCT00498602|E2|Reported Event|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126253|NCT00498602|E1|Reported Event|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1126254|NCT00498550|B3|Baseline|Total|Total of all reporting groups
1126255|NCT00498550|B2|Baseline|Treatment as Usual|Treatment as usual with any antipsychotic other than Clozapine.
1126256|NCT00498550|B1|Baseline|Clozapine|Clozapine, Clozaril
1126257|NCT00498550|P2|Participant Flow|Treatment as Usual|Treatment as usual with any antipsychotic other than Clozapine.
1126258|NCT00498550|P1|Participant Flow|Clozapine|Clozapine, Clozaril
1126259|NCT00498550|O2|Outcome|Treatment as Usual|Treatment as usual with any antipsychotic other than Clozapine.
1126260|NCT00498550|O1|Outcome|Clozapine|Clozapine, Clozaril
1126261|NCT00498550|E2|Reported Event|Treatment as Usual|Treatment as usual with any antipsychotic other than Clozapine.
1126262|NCT00498550|E1|Reported Event|Clozapine|Clozapine, Clozaril
1126263|NCT00498485|B3|Baseline|Total|Total of all reporting groups
1126265|NCT00498485|B1|Baseline|Placebo|Xyrem: Volunteers will complete questionnaires about their symptoms and a computerized test to assess their degree of brain fog. They will be randomly assigned to one of two groups, placebo or drug. Volunteers will know what group they are in at end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks like the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predeterm
1126266|NCT00498485|P2|Participant Flow|Xyrem|Xyrem: Same as for Placebo
1126267|NCT00498485|P1|Participant Flow|Placebo|Xyrem: Volunteers will complete questionnaires about their symptoms. They will be randomly assigned to one of two groups, placebo or drug. Volunteers will know what group they are in at end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks like the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predeterm
1126268|NCT00498485|O2|Outcome|Xyrem|Xyrem: Same as for Placebo
1126269|NCT00498485|O1|Outcome|Placebo|Xyrem: Volunteers will complete questionnaires about their symptoms. They will be randomly assigned to one of two groups, placebo or drug. Volunteers will know what group they are in at end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks like the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predeterm
1126270|NCT00498485|O2|Outcome|Drug Treated|Xyrem: Volunteers will complete questionnaires. They will be randomly assigned to one of two groups, placebo or drug. Volunteers will know what group they are in at end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks like the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved.
1126271|NCT00498485|O1|Outcome|Placebo|Xyrem: Volunteers will complete questionnaires. They will be randomly assigned to one of two groups, placebo or drug. Volunteers will know what group they are in at end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks like the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved.
1126272|NCT00498485|E2|Reported Event|Xyrem|Xyrem: Same as for Placebo
1126273|NCT00498485|E1|Reported Event|Placebo|Xyrem: Volunteers will complete questionnaires about their symptoms and a computerized test to assess their degree of brain fog. They will be randomly assigned to one of two groups, placebo or drug. Volunteers will know what group they are in at end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks like the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predeterm
1126274|NCT00498433|B4|Baseline|Total|Total of all reporting groups
1138835|NCT00464438|O2|Outcome|Moxifloxacin 0.5%|
1126276|NCT00498433|B2|Baseline|Part 2, Double Blind Period: Aliskiren|Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
1126277|NCT00498433|B1|Baseline|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
1126278|NCT00498433|P3|Participant Flow|Amlodipine|"Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks.~Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks"
1126279|NCT00498433|P2|Participant Flow|Aliskiren|"Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks"
1126280|NCT00498433|P1|Participant Flow|Placebo|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 2, Period 1: After confirming study eligibility based on inclusion and exclusion criteria, patients underwent a two week single-blind placebo run-in phase."
1126281|NCT00498433|O3|Outcome|Amlodipine|Part 2, Double Blind: Eligible randomized patients of this arm received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
1126282|NCT00498433|O2|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients of this arm received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
1126283|NCT00498433|O1|Outcome|Placebo run-in|Part 2, Period 1, Placebo run-in phase: After confirming study eligibility based on inclusion and exclusion criteria, patients will undergo a two week single-blind placebo run-in phase.
1126284|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
1126285|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
1126286|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
1126287|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
1126288|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
1126289|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
1126290|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients of this arm received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
1126291|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients of this arm received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
1126292|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
1126293|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
1126294|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
1126295|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
1126296|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
1126297|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
1126298|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
1126299|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
1126300|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
1126301|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
1126302|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
1138836|NCT00464438|O1|Outcome|Gatifloxacin 0.3%|
1126303|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
1126304|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
1126305|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
1126329|NCT00498368|O2|Outcome|ACE/ARB|"ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement~ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a B/P goal of <130/80 millimeters of mercury (mmHg)~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
1126306|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
1126307|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
1126308|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
1126309|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
1126310|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
1126311|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
1126312|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
1126313|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
1126314|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
1126315|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
1126316|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
1126317|NCT00498433|E5|Reported Event|Part 2: Amlodipine|Double Blind Period: Eligible randomized patients of this arm received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
1126318|NCT00498433|E4|Reported Event|Part 2: Aliskiren|Eligible randomized patients of this arm received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
1126319|NCT00498433|E3|Reported Event|Part 2: Placebo run-in Period|After confirming study eligibility based on inclusion and exclusion criteria, patients will undergo a two week single-blind placebo run-in phase.
1126320|NCT00498433|E2|Reported Event|Part 1: Amlodipine|All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks.
1126321|NCT00498433|E1|Reported Event|Part 1: Aliskiren|All eligible patients received 4 week treatment of 300 mg aliskiren o.d..
1126322|NCT00498368|B3|Baseline|Total|Total of all reporting groups
1126323|NCT00498368|B2|Baseline|ACE/ARB|"ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement~ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a blood pressure goal of <130/80 millimeters of mercury (mmHg)~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
1126324|NCT00498368|B1|Baseline|Rituximab Plus ACE/ARB|"Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement~Intravenous Rituximab: Rituximab Therapy [27 Patients]~Rituximab 1 gm IV on Treatment Day 1~Rituximab 1 gm IV on Treatment Day 15~Rituximab 1 gm IV on Treatment Day 168~Rituximab 1 gm IV on Treatment Day 182~An ACE inhibitors and /or ARBs will be used to achieve a blood pressure goal of <130/80 millimeters of mercury (mmHg)~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
1126325|NCT00498368|P2|Participant Flow|ACE/ARB|"ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement~ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a B/P goal of <130/80 millimeters of mercury (mmHg)~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
1126326|NCT00498368|P1|Participant Flow|Rituximab Plus ACE/ARB|"Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement~Intravenous Rituximab: Rituximab Therapy [27 Patients]~Rituximab 1 gm IV on Treatment Day 1~Rituximab 1 gm IV on Treatment Day 15~Rituximab 1 gm IV on Treatment Day 168~Rituximab 1 gm IV on Treatment Day 182~An angiotensin converting enzyme (ACE) inhibitors and /or angiotensin II receptor blockers (ARBs) will be used to achieve a B/P goal of <130/80 millimeters of mercury~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
1126358|NCT00497874|O1|Outcome|Intervention|Usual primary care + computer-tailored intervention
1126327|NCT00498368|O2|Outcome|ACE/ARB|"ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement~ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a B/P goal of <130/80 millimeters of mercury (mmHg)~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
1126328|NCT00498368|O1|Outcome|Rituximab Plus ACE/ARB|"Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement~Intravenous Rituximab: Rituximab Therapy [27 Patients]~Rituximab 1 gm IV on Treatment Day 1~Rituximab 1 gm IV on Treatment Day 15~Rituximab 1 gm IV on Treatment Day 168~Rituximab 1 gm IV on Treatment Day 182~An angiotensin converting enzyme (ACE) inhibitors and /or angiotensin II receptor blockers (ARBs) will be used to achieve a B/P goal of <130/80 millimeters of mercury~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
1126371|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
1126372|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
1126330|NCT00498368|O1|Outcome|Rituximab Plus ACE/ARB|"Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement~Intravenous Rituximab: Rituximab Therapy [27 Patients]~Rituximab 1 gm IV on Treatment Day 1~Rituximab 1 gm IV on Treatment Day 15~Rituximab 1 gm IV on Treatment Day 168~Rituximab 1 gm IV on Treatment Day 182~An angiotensin converting enzyme (ACE) inhibitors and /or angiotensin II receptor blockers (ARBs) will be used to achieve a B/P goal of <130/80 millimeters of mercury~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
1126331|NCT00498368|O2|Outcome|ACE/ARB|"ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement~ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a B/P goal of <130/80 millimeters of mercury (mmHg)~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
1126332|NCT00498368|O1|Outcome|Rituximab Plus ACE/ARB|"Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement~Intravenous Rituximab: Rituximab Therapy [27 Patients]~Rituximab 1 gm IV on Treatment Day 1~Rituximab 1 gm IV on Treatment Day 15~Rituximab 1 gm IV on Treatment Day 168~Rituximab 1 gm IV on Treatment Day 182~An angiotensin converting enzyme (ACE) inhibitors and /or angiotensin II receptor blockers (ARBs) will be used to achieve a B/P goal of <130/80 millimeters of mercury~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
1126333|NCT00498368|O2|Outcome|ACE/ARB|"ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement~ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a B/P goal of <130/80 millimeters of mercury (mmHg)~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
1126334|NCT00498368|O1|Outcome|Rituximab Plus ACE/ARB|"Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement~Intravenous Rituximab: Rituximab Therapy [27 Patients]~Rituximab 1 gm IV on Treatment Day 1~Rituximab 1 gm IV on Treatment Day 15~Rituximab 1 gm IV on Treatment Day 168~Rituximab 1 gm IV on Treatment Day 182~An angiotensin converting enzyme (ACE) inhibitors and /or angiotensin II receptor blockers (ARBs) will be used to achieve a B/P goal of <130/80 millimeters of mercury~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
1126335|NCT00498368|E2|Reported Event|ACE/ARB|"ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement~ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a B/P goal of <130/80 millimeters of mercury (mmHg)~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
1126336|NCT00498368|E1|Reported Event|Rituximab Plus ACE/ARB|"Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement~Intravenous Rituximab: Rituximab Therapy [27 Patients]~Rituximab 1 gm IV on Treatment Day 1~Rituximab 1 gm IV on Treatment Day 15~Rituximab 1 gm IV on Treatment Day 168~Rituximab 1 gm IV on Treatment Day 182~An angiotensin converting enzyme (ACE) inhibitors and /or angiotensin II receptor blockers (ARBs) will be used to achieve a B/P goal of <130/80 millimeters of mercury~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
1126337|NCT00498355|B1|Baseline|Ranibizumab for Macular Edema|This study was an open-label, single-center, prospective, nonrandomized interventional case series of 7 eyes in 7 patients with controlled uveitis and persistent visually significant macular edema.
1126338|NCT00498355|P1|Participant Flow|Ranibizumab for Macular Edema|This study was an open-label, single-center, prospective, nonrandomized interventional case series of 7 eyes in 7 patients with controlled uveitis and persistent visually significant macular edema.
1126339|NCT00498355|O1|Outcome|Ranibizumab for Macular Edema|This study was an open-label, single-center, prospective, nonrandomized interventional case series of 7 eyes in 7 patients with controlled uveitis and persistent visually significant macular edema.
1126340|NCT00498355|E1|Reported Event|Ranibizumab for Macular Edema|This study was an open-label, single-center, prospective, nonrandomized interventional case series of 7 eyes in 7 patients with controlled uveitis and persistent visually significant macular edema.
1126341|NCT00498186|B1|Baseline|Rotigotine|Rotigotine trans-dermal patch
1126342|NCT00498186|P1|Participant Flow|Rotigotine|Rotigotine trans-dermal patch
1126343|NCT00498186|O1|Outcome|Rotigotine|Rotigotine trans-dermal patch
1126344|NCT00498186|O1|Outcome|Rotigotine|Rotigotine trans-dermal patch
1126345|NCT00498186|E1|Reported Event|Rotigotine|Rotigotine trans-dermal patch
1126346|NCT00497874|B3|Baseline|Total|Total of all reporting groups
1126347|NCT00497874|B2|Baseline|Usual Care|Usual primary care treatment
1126348|NCT00497874|B1|Baseline|Intervention|Stage-based manual and three computer-tailored reports
1126349|NCT00497874|P2|Participant Flow|Usual Care|Usual primary care treatment
1126350|NCT00497874|P1|Participant Flow|Intervention|Stage-based manual and three computer-tailored reports
1126351|NCT00497874|O2|Outcome|Usual Care|Usual primary care
1126352|NCT00497874|O1|Outcome|Intervention|Usual primary care + computer-tailored intervention
1126353|NCT00497874|O2|Outcome|Usual Care|Usual primary care
1126354|NCT00497874|O1|Outcome|Intervention|Usual primary care + computer-tailored intervention
1126355|NCT00497874|O2|Outcome|Usual Care|Usual primary care
1126356|NCT00497874|O1|Outcome|Intervention|Usual primary care + computer-tailored intervention
1126360|NCT00497874|O1|Outcome|Intervention|Stage-based manual and three computer-tailored reports
1126361|NCT00497874|O2|Outcome|Usual Care|Usual primary care
1126362|NCT00497874|O1|Outcome|Intervention|Usual primary care + computer-tailored intervention
1126363|NCT00497874|E2|Reported Event|Usual Care|Usual primary care treatment
1126364|NCT00497874|E1|Reported Event|Intervention|Stage-based manual and three computer-tailored reports
1126365|NCT00497796|B3|Baseline|Total|Total of all reporting groups
1126366|NCT00497796|B2|Baseline|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
1126367|NCT00497796|B1|Baseline|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
1126368|NCT00497796|P2|Participant Flow|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
1126369|NCT00497796|P1|Participant Flow|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
1126370|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
1126374|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
1126375|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
1126376|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
1126377|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
1126378|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
1126379|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
1126380|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
1126381|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
1126382|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
1126383|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
1126384|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
1126385|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
1126386|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
1126387|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
1126388|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
1126389|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
1126390|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
1126391|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
1126392|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
1126393|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
1126394|NCT00497796|E2|Reported Event|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
1126395|NCT00497796|E1|Reported Event|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
1126396|NCT00497198|B3|Baseline|Total|Total of all reporting groups
1126397|NCT00497198|B2|Baseline|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
1126398|NCT00497198|B1|Baseline|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
1126399|NCT00497198|P2|Participant Flow|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
1126400|NCT00497198|P1|Participant Flow|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
1126401|NCT00497198|O2|Outcome|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
1126402|NCT00497198|O1|Outcome|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
1126403|NCT00497198|O2|Outcome|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
1126404|NCT00497198|O1|Outcome|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
1126405|NCT00497198|O2|Outcome|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
1126406|NCT00497198|O1|Outcome|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
1126407|NCT00497198|O2|Outcome|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
1126408|NCT00497198|O1|Outcome|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
1126409|NCT00497198|O2|Outcome|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
1126410|NCT00497198|O1|Outcome|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
1126411|NCT00497198|E2|Reported Event|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
1126412|NCT00497198|E1|Reported Event|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
1126413|NCT00497146|B3|Baseline|Total|Total of all reporting groups
1126414|NCT00497146|B2|Baseline|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126465|NCT00497081|O2|Outcome|Placebo Comparator:|placebo 30 mg daily for 3 months
1126415|NCT00497146|B1|Baseline|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126416|NCT00497146|P2|Participant Flow|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126417|NCT00497146|P1|Participant Flow|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126418|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126483|NCT00496964|B2|Baseline|Placebo Injection + Exercise|Placebo injection into Vastus Lateralis + exercise
1131360|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
1126419|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126420|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126421|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126422|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126423|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126424|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126425|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126426|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126427|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126428|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126429|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126430|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126431|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126432|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126433|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126434|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126435|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126466|NCT00497081|O1|Outcome|Active Comparator:|mirtazapine 30 mg daily for 3 months
1126436|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126437|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126438|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126439|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126440|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126441|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126442|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126443|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126444|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126445|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126446|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126447|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126448|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126449|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126450|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126451|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126452|NCT00497146|E4|Reported Event|Placebo: Long-term Follow-up|Participants who received placebo and completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126453|NCT00497146|E3|Reported Event|Paricalcitol: Long-term Follow-up|Participants who received paricalcitol and completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
1126454|NCT00497146|E2|Reported Event|Placebo: Treatment Period|Participants received 2 placebo capsules once a day for up to 48 weeks.
1126455|NCT00497146|E1|Reported Event|Paricalcitol: Treatment Period|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks.
1126456|NCT00497081|B3|Baseline|Total|Total of all reporting groups
1126457|NCT00497081|B2|Baseline|Placebo Comparator:|placebo 30 mg daily for 3 months
1126458|NCT00497081|B1|Baseline|Active Comparator:|mirtazapine 30 mg daily for 3 months
1126459|NCT00497081|P2|Participant Flow|Placebo Comparator:|placebo 30 mg daily for 3 months
1126460|NCT00497081|P1|Participant Flow|Active Comparator:|mirtazapine 30 mg daily for 3 months
1126461|NCT00497081|O2|Outcome|Placebo Comparator:|placebo 30 mg daily for 3 months
1126462|NCT00497081|O1|Outcome|Active Comparator:|mirtazapine 30 mg daily for 3 months
1126463|NCT00497081|O2|Outcome|Placebo Comparator:|placebo 30 mg daily for 3 months
1126464|NCT00497081|O1|Outcome|Active Comparator:|mirtazapine 30 mg daily for 3 months
1126467|NCT00497081|E2|Reported Event|Placebo Comparator:|placebo 30 mg daily for 3 months
1126468|NCT00497081|E1|Reported Event|Active Comparator:|mirtazapine 30 mg daily for 3 months
1126469|NCT00497055|B3|Baseline|Total|Total of all reporting groups
1126470|NCT00497055|B2|Baseline|Placebo|placebo daily for 3 months
1126471|NCT00497055|B1|Baseline|Aripiprazole|aripiprazole daily for 3 months
1126472|NCT00497055|P2|Participant Flow|Placebo|Placebo (for Aripiprazole) 5mg daily for week one. Placebo (for Aripiprazole) 10mg daily for week two. Placebo (for Aripiprazole) 20mg daily for weeks three through twelve.
1126473|NCT00497055|P1|Participant Flow|Aripiprazole|Aripiprazole 5mg daily for week one. Aripiprazole 10mg daily for week two. Aripiprazole 20mg daily for weeks three through twelve.
1126474|NCT00497055|O2|Outcome|Placebo|placebo daily for 3 months
1126475|NCT00497055|O1|Outcome|Aripiprazole|aripiprazole daily for 3 months
1126476|NCT00497055|O2|Outcome|Placebo|placebo daily for 3 months
1126477|NCT00497055|O1|Outcome|Aripiprazole|aripiprazole daily for 3 months
1126478|NCT00497055|O2|Outcome|Placebo|placebo daily for 3 months
1126484|NCT00496964|B1|Baseline|Botulinum Toxin A Injection + Exercise|Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program
1126485|NCT00496964|P2|Participant Flow|Placebo Injection + Exercise|Placebo injection into Vastus Lateralis + exercise
1126486|NCT00496964|P1|Participant Flow|Botulinum Toxin A Injection + Exercise|Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program
1126487|NCT00496964|O2|Outcome|Placebo Injection + Exercise|Placebo injection into Vastus Lateralis + exercise
1126488|NCT00496964|O1|Outcome|Botulinum Toxin A Injection + Exercise|Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program
1126489|NCT00496964|O2|Outcome|Placebo Injection + Exercise|Placebo injection into Vastus Lateralis + exercise
1126490|NCT00496964|O1|Outcome|Botulinum Toxin A Injection + Exercise|Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program
1126491|NCT00496964|E2|Reported Event|Placebo Injection + Exercise|Placebo injection into Vastus Lateralis + exercise
1126492|NCT00496964|E1|Reported Event|Botulinum Toxin A Injection + Exercise|Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program
1126493|NCT00496873|B1|Baseline|Cytoxan + Rituxan + Nipent|Cytoxan 600 mg/m^2, Rituxan 375 mg/m^2 and Nipent 4 mg/m^2 on Day 1 of 21 Day Cycle.
1126494|NCT00496873|P1|Participant Flow|Cytoxan + Rituxan + Nipent|Cytoxan 600 mg/m^2, Rituxan 375 mg/m^2 and Nipent 4 mg/m^2 on Day 1 of 21 Day Cycle.
1126495|NCT00496873|O1|Outcome|Cytoxan + Rituxan + Nipent|Cytoxan 600 mg/m^2, Rituxan 375 mg/m^2 and Nipent 4 mg/m^2 on Day 1 of 21 Day Cycle.
1126496|NCT00496873|O1|Outcome|Cytoxan + Rituxan + Nipent|Cytoxan 600 mg/m^2, Rituxan 375 mg/m^2 and Nipent 4 mg/m^2 on Day 1 of 21 Day Cycle.
1126497|NCT00496873|O1|Outcome|Cytoxan + Rituxan + Nipent|Cytoxan 600 mg/m^2, Rituxan 375 mg/m^2 and Nipent 4 mg/m^2 on Day 1 of 21 Day Cycle.
1126498|NCT00496873|E1|Reported Event|Cytoxan + Rituxan + Nipent|Cytoxan 600 mg/m^2, Rituxan 375 mg/m^2 and Nipent 4 mg/m^2 on Day 1 of 21 Day Cycle.
1126499|NCT00496860|B4|Baseline|Total|Total of all reporting groups
1126500|NCT00496860|B3|Baseline|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
1126501|NCT00496860|B2|Baseline|ALT-801 0.040 mg/kg/Dose|0.040 mg/kg/dose of ALT-801
1126502|NCT00496860|B1|Baseline|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
1126503|NCT00496860|P3|Participant Flow|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
1126504|NCT00496860|P2|Participant Flow|ALT-801 0.040 mg/kg/ Dose|0.040 mg/kg/dose of ALT-801
1126505|NCT00496860|P1|Participant Flow|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
1126506|NCT00496860|O3|Outcome|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
1126507|NCT00496860|O2|Outcome|ALT-801 0.040 mg/kg/Dose|0.040 mg/kg/dose of ALT-801
1126508|NCT00496860|O1|Outcome|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
1126509|NCT00496860|O3|Outcome|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
1126510|NCT00496860|O2|Outcome|ALT-801 0.040 mg/kg/Dose|0.040 mg/kg/dose of ALT-801
1126511|NCT00496860|O1|Outcome|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
1126512|NCT00496860|O3|Outcome|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
1126513|NCT00496860|O2|Outcome|ALT-801 0.040 mg/kg/Dose|0.040 mg/kg/dose of ALT-801
1126514|NCT00496860|O1|Outcome|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
1126515|NCT00496860|O3|Outcome|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
1126516|NCT00496860|O2|Outcome|ALT-801 0.040 mg/kg/Dose|0.040 mg/kg/dose of ALT-801
1126517|NCT00496860|O1|Outcome|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
1126518|NCT00496860|O3|Outcome|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
1126519|NCT00496860|O2|Outcome|ALT-801 0.040 mg/kg/Dose|0.040 mg/kg/dose of ALT-801
1126520|NCT00496860|O1|Outcome|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
1126521|NCT00496860|E3|Reported Event|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
1126522|NCT00496860|E2|Reported Event|ALT-801 0.040 mg/kg/Dose|0.040 mg/kg/dose of ALT-801
1126523|NCT00496860|E1|Reported Event|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
1126524|NCT00496834|B3|Baseline|Total|Total of all reporting groups
1126525|NCT00496834|B2|Baseline|Carvedilol|"Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or~Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan)."
1126624|NCT00496626|O2|Outcome|Placebo Group|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
1126526|NCT00496834|B1|Baseline|Losartan|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan).
1126527|NCT00496834|P2|Participant Flow|Carvedilol|"Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or~Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan)."
1126528|NCT00496834|P1|Participant Flow|Losartan|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan).
1126542|NCT00496808|O1|Outcome|Herceptin|8 mg/kg intravenously (IV) Over 90 Minutes
1126543|NCT00496808|E1|Reported Event|Herceptin|8 mg/kg intravenously (IV) Over 90 Minutes
1126544|NCT00496782|B3|Baseline|Total|Total of all reporting groups
1126669|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1131361|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
1126529|NCT00496834|O2|Outcome|Carvedilol|"Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or~Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration and 4) did not commit major violation."
1126530|NCT00496834|O1|Outcome|Losartan|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration and 4) did not commit major violation.
1126531|NCT00496834|O2|Outcome|Carvedilol|"Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or~Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration and 4) did not commit major violation."
1126532|NCT00496834|O1|Outcome|Losartan|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration and 4) did not commit major violation.
1126533|NCT00496834|O2|Outcome|Carvedilol|"Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or~Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration 4) did not commit major violation and 5) did not have protocol violation including erroneous prescription of the investigational drug, baseline PWV test date violation, PWV test date violation 24 weeks after the administration of the investigational drug, titration violation, use of prohibited concomitant drugs, visit window violation and inclusion/exclusion criteria violation."
1126534|NCT00496834|O1|Outcome|Losartan|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration 4) did not commit major violation and 5) did not have protocol violation including erroneous prescription of the investigational drug, baseline PWV test date violation, PWV test date violation 24 weeks after the administration of the investigational drug, titration violation, use of prohibited concomitant drugs, visit window violation and inclusion/exclusion criteria violation.
1126535|NCT00496834|O2|Outcome|Carvedilol|"Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or~Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration and 4) did not commit major violation."
1126536|NCT00496834|O1|Outcome|Losartan|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration and 4) did not commit major violation.
1126588|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once, with dosage based on investigator discretion.
1126625|NCT00496626|O1|Outcome|Vaccine (Gardasil®) Group|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
1126537|NCT00496834|E2|Reported Event|Carvedilol|"Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or~Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Subjects who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who received the investigational drug at least more than once."
1126538|NCT00496834|E1|Reported Event|Losartan|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Subjects who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who received the investigational drug at least more than once.
1126539|NCT00496808|B1|Baseline|Herceptin|8 mg/kg intravenously (IV) Over 90 Minutes
1126540|NCT00496808|P1|Participant Flow|Herceptin|8 mg/kg intravenously (IV) Over 90 Minutes
1126541|NCT00496808|O1|Outcome|Herceptin|8 mg/kg intravenously (IV) Over 90 Minutes
1126545|NCT00496782|B2|Baseline|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
1126546|NCT00496782|B1|Baseline|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
1126547|NCT00496782|P2|Participant Flow|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
1126548|NCT00496782|P1|Participant Flow|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
1126549|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
1126550|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
1126551|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
1126552|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
1126553|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
1126554|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
1126555|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
1126621|NCT00496626|P1|Participant Flow|Vaccine (Gardasil®) Group|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
1126840|NCT00495820|O2|Outcome|Placebo Group|Subjects randomized to this group received placebo
1126556|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
1126557|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
1126558|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
1126559|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
1126560|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
1126561|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
1126562|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
1126563|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
1126564|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
1126565|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
1126566|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
1126567|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
1126568|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
1126569|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
1126622|NCT00496626|O2|Outcome|Placebo Group|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
1126623|NCT00496626|O1|Outcome|Vaccine (Gardasil®) Group|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
1126570|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
1126571|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
1126572|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
1126573|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
1126574|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
1126575|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
1126576|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
1126577|NCT00496782|E2|Reported Event|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
1126578|NCT00496782|E1|Reported Event|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
1126579|NCT00496769|B3|Baseline|Total|Total of all reporting groups
1126580|NCT00496769|B2|Baseline|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion
1126581|NCT00496769|B1|Baseline|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
1126582|NCT00496769|P2|Participant Flow|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion
1126583|NCT00496769|P1|Participant Flow|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
1126584|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion
1126585|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
1126586|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once, with dosage based on investigator discretion.
1126587|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
1126589|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
1126590|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once, with dosage based on investigator discretion.
1126591|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
1126592|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once, with dosage based on investigator discretion.
1126632|NCT00496483|B1|Baseline|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
1131362|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
1126593|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
1126594|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once, with dosage based on investigator discretion
1126595|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
1126596|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion
1126597|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
1126598|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once, with dosage based on investigator discretion.
1126599|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
1126600|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion
1126601|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
1126602|NCT00496769|E2|Reported Event|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion
1126603|NCT00496769|E1|Reported Event|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
1126604|NCT00496730|B3|Baseline|Total|Total of all reporting groups
1126605|NCT00496730|B2|Baseline|Atorvastatin|atorvastatin 10 mg; tablet, once daily, 8 Weeks
1126606|NCT00496730|B1|Baseline|Vytorin|simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
1126607|NCT00496730|P2|Participant Flow|Atorvastatin|atorvastatin 10 mg; tablet, once daily, 8 Weeks
1126608|NCT00496730|P1|Participant Flow|Vytorin|simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
1126609|NCT00496730|O2|Outcome|Atorvastatin|atorvastatin 10 mg; tablet, once daily, 8 Weeks
1126610|NCT00496730|O1|Outcome|Vytorin|simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
1126611|NCT00496730|O2|Outcome|Atorvastatin|atorvastatin 10 mg; tablet, once daily, 8 Weeks
1126612|NCT00496730|O1|Outcome|Vytorin|simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
1126613|NCT00496730|O2|Outcome|Atorvastatin|atorvastatin 10 mg; tablet, once daily, 8 Weeks
1126614|NCT00496730|O1|Outcome|Vytorin|simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
1126615|NCT00496730|E2|Reported Event|Atorvastatin|atorvastatin 10 mg; tablet, once daily, 8 Weeks
1126616|NCT00496730|E1|Reported Event|Vytorin|simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
1126617|NCT00496626|B3|Baseline|Total|Total of all reporting groups
1126618|NCT00496626|B2|Baseline|Placebo Group|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
1126619|NCT00496626|B1|Baseline|Vaccine (Gardasil®) Group|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
1126620|NCT00496626|P2|Participant Flow|Placebo Group|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
1126841|NCT00495820|O1|Outcome|Methylphenidate Group|Subjects randomized to this group received methylphenidate
1126626|NCT00496626|O4|Outcome|Placebo Group (Month 7)|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
1126627|NCT00496626|O3|Outcome|Vaccine (Gardasil®) Group (Month 7)|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
1126628|NCT00496626|O2|Outcome|Placebo Group (Day 1)|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
1126629|NCT00496626|O1|Outcome|Vaccine (Gardasil®) Group (Day 1)|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
1126630|NCT00496626|E2|Reported Event|Placebo Group|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
1126631|NCT00496626|E1|Reported Event|Vaccine (Gardasil®) Group|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
1126668|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126633|NCT00496483|P1|Participant Flow|LCP-Tacro|"All Patients received Prograf for 7 days, then all patients were converted to once daily LCP-Tacro for 14 days. One dose adjustment up or down 25% was permitted on Day 15.~On Day 22 patients were converted back to their original twice daily dose of Prograf for a safety follow-up period of 30 days.~LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL."
1126634|NCT00496483|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
1126635|NCT00496483|O1|Outcome|Prograf|Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
1126636|NCT00496483|O1|Outcome|Prograf|Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
1126637|NCT00496483|O1|Outcome|Prograf|Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
1126638|NCT00496483|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
1126639|NCT00496483|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
1126640|NCT00496483|O1|Outcome|Prograf|Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
1126641|NCT00496483|O1|Outcome|Prograf|Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally twice daily, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
1126642|NCT00496483|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
1126643|NCT00496483|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
1126644|NCT00496483|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
1126645|NCT00496483|E2|Reported Event|Prograf|"Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally twice daily, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.~60 patients were entrolled into the study and one withdrew consent right after screening. Therefore 59 patients are inlcuded in the ITT safety set."
1126646|NCT00496483|E1|Reported Event|LCP-Tacro|"LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.~60 patients were enrolled into the study, but only 51 were dosed with LCP-Tacro."
1126647|NCT00496470|B3|Baseline|Total|Total of all reporting groups
1126648|NCT00496470|B2|Baseline|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126649|NCT00496470|B1|Baseline|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126650|NCT00496470|P2|Participant Flow|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126651|NCT00496470|P1|Participant Flow|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126652|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126653|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126654|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126655|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126656|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126657|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126658|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126659|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126660|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126661|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126662|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126663|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126664|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126665|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126666|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126667|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126670|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126671|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126672|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126673|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126674|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126675|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126676|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126677|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126678|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126679|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126680|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126681|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126682|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126683|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126684|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126685|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126686|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126687|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126688|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126689|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126690|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126691|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126692|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126693|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126694|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126695|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126696|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126697|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126698|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126699|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126700|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126701|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126702|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126703|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126704|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126705|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126706|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126707|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126708|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126709|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126710|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126711|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126712|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126713|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126714|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126715|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126716|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126717|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126718|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126719|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126720|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126721|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126722|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126723|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126724|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126725|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126726|NCT00496470|E2|Reported Event|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
1126727|NCT00496470|E1|Reported Event|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
1126728|NCT00496379|B1|Baseline|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
1126729|NCT00496379|P1|Participant Flow|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
1126730|NCT00496379|O1|Outcome|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
1126731|NCT00496379|O1|Outcome|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
1126732|NCT00496379|O1|Outcome|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
1126733|NCT00496379|O1|Outcome|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
1126734|NCT00496379|O1|Outcome|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
1126735|NCT00496379|E1|Reported Event|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
1126736|NCT00496366|B1|Baseline|Capecitabine (Xeloda) + Lapatinib (Tykerb)|"Capecitabine for 2 weeks straight (Days 1-14) followed by 1 week without capecitabine (Days 15-21).~Lapatinib will be taken daily continuously for 21 days (Days 1- 21).~Capecitabine: The dose of capecitabine is 1000 mg/m2/dose twice each day, orally, 12 hours apart, for 14 consecutive days, every 21 days (total daily dose = 2000 mg/m2).~Lapatinib: The daily dose of lapatinib is 1250 mg (5 tablets of 250 mg each) to be taken at approximately the same time each day, continuously. Lapatinib is taken even during the week that capecitabine is not taken."
1126737|NCT00496366|P1|Participant Flow|Capecitabine (Xeloda) + Lapatinib (Tykerb)|"Capecitabine for 2 weeks straight (Days 1-14) followed by 1 week without capecitabine (Days 15-21).~Lapatinib will be taken daily continuously for 21 days (Days 1- 21).~Capecitabine: The dose of capecitabine is 1000 mg/m2/dose twice each day, orally, 12 hours apart, for 14 consecutive days, every 21 days (total daily dose = 2000 mg/m2).~Lapatinib: The daily dose of lapatinib is 1250 mg (5 tablets of 250 mg each) to be taken at approximately the same time each day, continuously. Lapatinib is taken even during the week that capecitabine is not taken."
1126833|NCT00495820|B1|Baseline|Arm 1|"Methylphenidate~Methylphenidate: Subject will receive 5mg BID for two weeks then 10mg BID until week 12 of the study."
1126834|NCT00495820|P2|Participant Flow|Arm 2|"Placebo~Placebo: Standard inactive pill."
1138837|NCT00464438|O2|Outcome|Moxifloxacin 0.5%|
1126738|NCT00496366|O1|Outcome|Capecitabine (Xeloda) + Lapatinib (Tykerb)|"Capecitabine for 2 weeks straight (Days 1-14) followed by 1 week without capecitabine (Days 15-21).~Lapatinib will be taken daily continuously for 21 days (Days 1- 21).~Capecitabine: The dose of capecitabine is 1000 mg/m2/dose twice each day, orally, 12 hours apart, for 14 consecutive days, every 21 days (total daily dose = 2000 mg/m2).~Lapatinib: The daily dose of lapatinib is 1250 mg (5 tablets of 250 mg each) to be taken at approximately the same time each day, continuously. Lapatinib is taken even during the week that capecitabine is not taken."
1126739|NCT00496366|O1|Outcome|Capecitabine (Xeloda) + Lapatinib (Tykerb)|"Capecitabine for 2 weeks straight (Days 1-14) followed by 1 week without capecitabine (Days 15-21).~Lapatinib will be taken daily continuously for 21 days (Days 1- 21).~Capecitabine: The dose of capecitabine is 1000 mg/m2/dose twice each day, orally, 12 hours apart, for 14 consecutive days, every 21 days (total daily dose = 2000 mg/m2).~Lapatinib: The daily dose of lapatinib is 1250 mg (5 tablets of 250 mg each) to be taken at approximately the same time each day, continuously. Lapatinib is taken even during the week that capecitabine is not taken."
1126846|NCT00495794|B1|Baseline|Pharmacist Management|"Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)~Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms"
1126740|NCT00496366|E1|Reported Event|Capecitabine (Xeloda) + Lapatinib (Tykerb)|"Capecitabine for 2 weeks straight (Days 1-14) followed by 1 week without capecitabine (Days 15-21).~Lapatinib will be taken daily continuously for 21 days (Days 1- 21).~Capecitabine: The dose of capecitabine is 1000 mg/m2/dose twice each day, orally, 12 hours apart, for 14 consecutive days, every 21 days (total daily dose = 2000 mg/m2).~Lapatinib: The daily dose of lapatinib is 1250 mg (5 tablets of 250 mg each) to be taken at approximately the same time each day, continuously. Lapatinib is taken even during the week that capecitabine is not taken."
1126741|NCT00496340|B1|Baseline|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
1126742|NCT00496340|P1|Participant Flow|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total area under curve (AUC) of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
1126743|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
1126744|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
1126745|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
1126746|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
1126747|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
1126748|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
1126847|NCT00495794|P2|Participant Flow|Usual Care|Eligible patients receive usual care
1126886|NCT00495677|O5|Outcome|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
1131363|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
1126749|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
1126750|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
1126751|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
1126752|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
1126753|NCT00496340|E1|Reported Event|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
1126754|NCT00496262|B1|Baseline|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
1126755|NCT00496262|P1|Participant Flow|Human Fibrinogen Concentrate|All enrolled subjects received a single IV infusion of 70 mg/kg body weight of human fibrinogen concentrate.
1126756|NCT00496262|O1|Outcome|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
1126757|NCT00496262|O1|Outcome|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
1126758|NCT00496262|O1|Outcome|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
1126759|NCT00496262|O1|Outcome|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
1126760|NCT00496262|O1|Outcome|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
1126761|NCT00496262|O1|Outcome|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
1126762|NCT00496262|O1|Outcome|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
1126763|NCT00496262|O1|Outcome|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
1126764|NCT00496262|O2|Outcome|1 Hour Post-infusion|1 hour after end of infusion
1126765|NCT00496262|O1|Outcome|Pre-infusion|≤ 2 hours before start of infusion
1126766|NCT00496262|E1|Reported Event|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
1126767|NCT00496197|B1|Baseline|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
1126768|NCT00496197|P1|Participant Flow|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
1126884|NCT00495677|O7|Outcome|Placebo|Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126769|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
1126770|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
1126771|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
1126772|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
1126773|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
1126774|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
1126775|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
1126776|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
1126777|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
1126778|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
1126779|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
1126835|NCT00495820|P1|Participant Flow|Arm 1|"Methylphenidate~Methylphenidate: Subject will receive 5mg BID for two weeks then 10mg BID until week 12 of the study."
1126836|NCT00495820|O2|Outcome|Placebo Group|Subjects randomized to this group received placebo
1138838|NCT00464438|O1|Outcome|Gatifloxacin 0.3%|
1126780|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
1126781|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
1126782|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
1126783|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
1126784|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
1126785|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
1126786|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
1126787|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
1126788|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
1126789|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
1126790|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
1126791|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
1126837|NCT00495820|O1|Outcome|Methylphenidate Group|Subjects randomized to this group received methylphenidate
1126838|NCT00495820|O2|Outcome|Placebo Group|Subjects randomized to this group received placebo
1126839|NCT00495820|O1|Outcome|Methylphenidate Group|Subjects randomized to this group received methylphenidate
1126792|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
1126793|NCT00496197|E1|Reported Event|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
1126794|NCT00496080|B1|Baseline|DUAO Device|Doppler-guided uterine artery occlusion device (Single-arm study)
1126795|NCT00496080|P1|Participant Flow|DUAO Device|Doppler-guided uterine artery occlusion device (Single-arm study)
1126796|NCT00496080|O1|Outcome|DUAO Device|Doppler-guided uterine artery occlusion device (Single-arm study)
1126797|NCT00496080|O1|Outcome|DUAO Device|Doppler-guided uterine artery occlusion device (Single-arm study)
1126798|NCT00496080|O1|Outcome|DUAO Device|Doppler-guided uterine artery occlusion device (Single-arm study)
1126799|NCT00496080|O1|Outcome|DUAO Device|Doppler-guided uterine artery occlusion device
1126800|NCT00496080|O1|Outcome|DUAO Device|Doppler-guided uterine artery occlusion device
1126801|NCT00496080|O1|Outcome|DUAO Device|Doppler-guided uterine artery occlusion device
1126802|NCT00496080|O1|Outcome|DUAO Device|Doppler-guided uterine artery occlusion device
1126803|NCT00496080|E1|Reported Event|DUAO Device|Doppler-guided uterine artery occlusion device (Single-arm study)
1126804|NCT00496054|B1|Baseline|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
1126805|NCT00496054|P1|Participant Flow|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
1126806|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
1126807|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
1126808|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
1126809|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
1126810|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
1126811|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
1126812|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
1126813|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
1126814|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
1126815|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
1126816|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
1126817|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
1126818|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
1126819|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
1126820|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
1126821|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
1126822|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
1126823|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
1126824|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
1126825|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
1126826|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
1126827|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
1126828|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
1126829|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
1126830|NCT00496054|E1|Reported Event|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
1126831|NCT00495820|B3|Baseline|Total|Total of all reporting groups
1126832|NCT00495820|B2|Baseline|Arm 2|"Placebo~Placebo: Standard inactive pill."
1126842|NCT00495820|E2|Reported Event|Placebo Group|Subjects randomized to this group received methylphenidate
1126843|NCT00495820|E1|Reported Event|Methylphenidate Group|Subjects randomized to this group received methylphenidate
1126844|NCT00495794|B3|Baseline|Total|Total of all reporting groups
1126845|NCT00495794|B2|Baseline|Usual Care|Eligible patients receive usual care
1126885|NCT00495677|O6|Outcome|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
1126848|NCT00495794|P1|Participant Flow|Pharmacist Management|"Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)~Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms"
1126849|NCT00495794|O2|Outcome|Usual Care|Eligible patients receive usual care
1126850|NCT00495794|O1|Outcome|Pharmacist Management|"Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)~Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms"
1126851|NCT00495794|O2|Outcome|Usual Care|Eligible patients receive usual care
1126852|NCT00495794|O1|Outcome|Pharmacist Management|"Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)~Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms"
1126853|NCT00495794|O2|Outcome|Usual Care|Eligible patients receive usual care
1126854|NCT00495794|O1|Outcome|Pharmacist Management|"Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)~Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms"
1126855|NCT00495794|E2|Reported Event|Usual Care|Eligible patients receive usual care
1126856|NCT00495794|E1|Reported Event|Pharmacist Management|"Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)~Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms"
1126857|NCT00495755|B1|Baseline|Campath (Alemtuzumab)|
1126858|NCT00495755|P1|Participant Flow|Campath (Alemtuzumab)|3 dose cohorts entered
1126859|NCT00495755|O1|Outcome|Response|
1126860|NCT00495755|O1|Outcome|Maximum Tolerated Dose (MTD)|
1126861|NCT00495755|E1|Reported Event|Campath (Alemtuzumab)|
1126862|NCT00495677|B8|Baseline|Total|Total of all reporting groups
1126863|NCT00495677|B7|Baseline|Placebo|Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126864|NCT00495677|B6|Baseline|PF-00232798 400mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
1126865|NCT00495677|B5|Baseline|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
1126866|NCT00495677|B4|Baseline|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126867|NCT00495677|B3|Baseline|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
1126868|NCT00495677|B2|Baseline|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126869|NCT00495677|B1|Baseline|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126870|NCT00495677|P7|Participant Flow|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
1126871|NCT00495677|P6|Participant Flow|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
1126872|NCT00495677|P5|Participant Flow|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
1126873|NCT00495677|P4|Participant Flow|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126874|NCT00495677|P3|Participant Flow|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126875|NCT00495677|P2|Participant Flow|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126876|NCT00495677|P1|Participant Flow|Placebo|Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126877|NCT00495677|O7|Outcome|Placebo|Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126878|NCT00495677|O6|Outcome|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
1126879|NCT00495677|O5|Outcome|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
1126880|NCT00495677|O4|Outcome|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126881|NCT00495677|O3|Outcome|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
1126882|NCT00495677|O2|Outcome|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126883|NCT00495677|O1|Outcome|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126887|NCT00495677|O4|Outcome|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126888|NCT00495677|O3|Outcome|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
1126889|NCT00495677|O2|Outcome|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126890|NCT00495677|O1|Outcome|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126891|NCT00495677|O6|Outcome|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
1126892|NCT00495677|O5|Outcome|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
1126893|NCT00495677|O4|Outcome|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126894|NCT00495677|O3|Outcome|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
1126895|NCT00495677|O2|Outcome|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126896|NCT00495677|O1|Outcome|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126897|NCT00495677|O6|Outcome|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
1126898|NCT00495677|O5|Outcome|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
1126899|NCT00495677|O4|Outcome|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126900|NCT00495677|O3|Outcome|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
1126901|NCT00495677|O2|Outcome|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126902|NCT00495677|O1|Outcome|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126903|NCT00495677|O6|Outcome|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
1126904|NCT00495677|O5|Outcome|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
1126905|NCT00495677|O4|Outcome|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126906|NCT00495677|O3|Outcome|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
1126907|NCT00495677|O2|Outcome|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126908|NCT00495677|O1|Outcome|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126909|NCT00495677|O7|Outcome|Placebo|Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126910|NCT00495677|O6|Outcome|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
1126911|NCT00495677|O5|Outcome|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
1126912|NCT00495677|O4|Outcome|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126913|NCT00495677|O3|Outcome|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
1126914|NCT00495677|O2|Outcome|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126915|NCT00495677|O1|Outcome|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126916|NCT00495677|O7|Outcome|Placebo|Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126917|NCT00495677|O6|Outcome|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
1126918|NCT00495677|O5|Outcome|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
1126919|NCT00495677|O4|Outcome|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126920|NCT00495677|O3|Outcome|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
1126921|NCT00495677|O2|Outcome|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126922|NCT00495677|O1|Outcome|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126923|NCT00495677|E7|Reported Event|Placebo|Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126924|NCT00495677|E6|Reported Event|PF-00232798 400mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
1126925|NCT00495677|E5|Reported Event|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
1126926|NCT00495677|E4|Reported Event|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1127238|NCT00494442|O1|Outcome|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
1126927|NCT00495677|E3|Reported Event|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
1126928|NCT00495677|E2|Reported Event|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126929|NCT00495677|E1|Reported Event|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
1126930|NCT00495625|B1|Baseline|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
1126931|NCT00495625|P1|Participant Flow|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
1126932|NCT00495625|O1|Outcome|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
1126933|NCT00495625|O1|Outcome|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
1126934|NCT00495625|O1|Outcome|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
1126935|NCT00495625|O1|Outcome|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
1126936|NCT00495625|O1|Outcome|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
1126937|NCT00495625|O1|Outcome|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
1126938|NCT00495625|E1|Reported Event|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
1126939|NCT00495612|B3|Baseline|Total|Total of all reporting groups
1126940|NCT00495612|B2|Baseline|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
1126941|NCT00495612|B1|Baseline|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
1126942|NCT00495612|P2|Participant Flow|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
1126943|NCT00495612|P1|Participant Flow|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
1126944|NCT00495612|O2|Outcome|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
1126945|NCT00495612|O1|Outcome|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
1126946|NCT00495612|O2|Outcome|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
1126947|NCT00495612|O1|Outcome|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
1126948|NCT00495612|O2|Outcome|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
1126949|NCT00495612|O1|Outcome|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
1126950|NCT00495612|O2|Outcome|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
1126951|NCT00495612|O1|Outcome|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
1126952|NCT00495612|O2|Outcome|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
1126953|NCT00495612|O1|Outcome|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
1131364|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
1126954|NCT00495612|O2|Outcome|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
1126955|NCT00495612|O1|Outcome|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
1126956|NCT00495612|E2|Reported Event|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
1126957|NCT00495612|E1|Reported Event|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
1126958|NCT00495586|B3|Baseline|Total|Total of all reporting groups
1126959|NCT00495586|B2|Baseline|Amoxycillin and Clavulanic Acid|Amoxycillin and clavulanate t.i.d. for 8 days
1126960|NCT00495586|B1|Baseline|Placebo|Placebo pills t.i.d. for 8 days
1126961|NCT00495586|P2|Participant Flow|Amoxycillin and Clavulanic Acid|Amoxycillin and clavulanate t.i.d. for 8 days
1126962|NCT00495586|P1|Participant Flow|Placebo|Placebo pills t.i.d. for 8 days
1126963|NCT00495586|O2|Outcome|Placebo|Ninety exacerbations were reported during the year of follow up among those patients who had clinical success at end of therapy visit (90/123: 73.2%)
1126964|NCT00495586|O1|Outcome|Amoxicillin and Clavulanic Acid|Eighty-three exacerbations were reported during the year of follow up among those patients who had clinical success at end of therapy visit (83/143: 58%)
1126965|NCT00495586|O2|Outcome|Amoxycillin and Clavulanic Acid|Amoxycillin and clavulanate t.i.d. for 8 days
1126966|NCT00495586|O1|Outcome|Placebo|Placebo pills t.i.d. for 8 days
1126967|NCT00495586|E2|Reported Event|Amoxycillin and Clavulanic Acid|Amoxycillin and clavulanate t.i.d. for 8 days
1126968|NCT00495586|E1|Reported Event|Placebo|Placebo pills t.i.d. for 8 days
1126969|NCT00495495|B1|Baseline|Ozone Treatment/Placebo Treatment|Study utilized split-mouth design. Each participant had two teeth selected at the start of the study. Each participant was then randomized to receive Ozone treatment on a randomly selected study tooth for 60 seconds and Placebo treatment on a randomly selected study tooth for 60 seconds.
1126970|NCT00495495|P1|Participant Flow|Ozone Treatment and Placebo Treatment|60-second Ozone device treatment compared to 60-second Placebo device treatment. Study utilized split-mouth design. The paired treatment assignment for the two teeth within each subject was performed according to a randomization table provided by the Biometrician. Randomization of teeth to Ozone treatment or Placebo treatment was stratifed according to tooth similarity.
1126971|NCT00495495|O2|Outcome|Placebo Treatment|As part of the split-mouth design, subjects were randomized to receive placebo treatment on a randomly selected study tooth for 60 seconds.
1126972|NCT00495495|O1|Outcome|Ozone Treatment|As part of the split-mouth design, subjects were randomized to receive Ozone treatment on a randomly selected study tooth for 60 seconds.
1126973|NCT00495495|O2|Outcome|Placebo Treatment|As part of the split-mouth design, subjects were randomized to receive placebo treatment on a randomly selected study tooth for 60 seconds.
1126974|NCT00495495|O1|Outcome|Ozone Treatment|As part of the split-mouth design, subjects were randomized to receive Ozone treatment on a randomly selected study tooth for 60 seconds.
1126975|NCT00495495|O2|Outcome|Placebo Treatment|As part of the split-mouth design, subjects were randomized to receive placebo treatment on a randomly selected study tooth for 60 seconds.
1126976|NCT00495495|O1|Outcome|Ozone Treatment|As part of the split-mouth design, subjects were randomized to receive Ozone treatment on a randomly selected study tooth for 60 seconds.
1126977|NCT00495495|O2|Outcome|Placebo Treatment|As part of the split-mouth design, subjects were randomized to receive placebo treatment on a randomly selected study tooth for 60 seconds.
1126978|NCT00495495|O1|Outcome|Ozone Treatment|As part of the split-mouth design, subjects were randomized to receive Ozone treatment on a randomly selected study tooth for 60 seconds.
1126979|NCT00495495|O2|Outcome|Placebo Treatment|As part of the split-mouth design, subjects were randomized to receive placebo treatment on a randomly selected study tooth for 60 seconds.
1126980|NCT00495495|O1|Outcome|Ozone Treatment|As part of the split-mouth design, subjects were randomized to receive Ozone treatment on a randomly selected study tooth for 60 seconds.
1126981|NCT00495495|E1|Reported Event|Ozone Treatment and Placebo Treatment|Study utilized split-mouth design. Each participant had two teeth selected at the start of the study. Each participant was then randominzed to receive Ozone treatment on a randomly selected study tooth for 60 seconds and Placebo treatment on a randomly selected study tooth for 60 seconds.
1126982|NCT00495391|B3|Baseline|Total|Total of all reporting groups
1127229|NCT00494442|P2|Participant Flow|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
1126983|NCT00495391|B2|Baseline|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
1126984|NCT00495391|B1|Baseline|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
1127023|NCT00495131|B1|Baseline|Peginterferon and Ribavirin (24 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
1131365|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
1126985|NCT00495391|P2|Participant Flow|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
1126986|NCT00495391|P1|Participant Flow|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
1126987|NCT00495391|O2|Outcome|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
1126988|NCT00495391|O1|Outcome|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
1126989|NCT00495391|O2|Outcome|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
1126990|NCT00495391|O1|Outcome|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
1126991|NCT00495391|O2|Outcome|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
1126992|NCT00495391|O1|Outcome|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
1126993|NCT00495391|O2|Outcome|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
1126994|NCT00495391|O1|Outcome|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
1126995|NCT00495391|O2|Outcome|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
1127230|NCT00494442|P1|Participant Flow|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
1126996|NCT00495391|O1|Outcome|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
1126997|NCT00495391|O2|Outcome|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
1126998|NCT00495391|O1|Outcome|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
1126999|NCT00495391|O2|Outcome|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
1127000|NCT00495391|O1|Outcome|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
1127001|NCT00495391|O2|Outcome|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
1127002|NCT00495391|O1|Outcome|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
1127003|NCT00495391|E2|Reported Event|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
1127004|NCT00495391|E1|Reported Event|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
1127005|NCT00495222|B1|Baseline|Tissue Plication|
1127006|NCT00495222|P1|Participant Flow|Tissue Plication|
1127007|NCT00495222|O1|Outcome|Tissue Plication|
1127008|NCT00495157|B4|Baseline|Total|Total of all reporting groups
1127009|NCT00495157|B3|Baseline|Guideline-based Adjustment|Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
1127010|NCT00495157|B2|Baseline|Biomarker-based Adjustment|Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
1127011|NCT00495157|B1|Baseline|Symptom-based Adjustment|Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
1127012|NCT00495157|P3|Participant Flow|Guideline-based Adjustment|Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
1127013|NCT00495157|P2|Participant Flow|Biomarker-based Adjustment|Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
1127014|NCT00495157|P1|Participant Flow|Symptom-based Adjustment|Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
1127015|NCT00495157|O3|Outcome|Guideline-based Adjustment|Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
1127016|NCT00495157|O2|Outcome|Biomarker-based Adjustment|Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
1127017|NCT00495157|O1|Outcome|Symptom-based Adjustment|Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
1127290|NCT00494221|O1|Outcome|Cediranib 20 mg|FOLFOX + Cediranib 20 mg
1127018|NCT00495157|E3|Reported Event|Guideline-based Adjustment|Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
1127019|NCT00495157|E2|Reported Event|Biomarker-based Adjustment|Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
1127020|NCT00495157|E1|Reported Event|Symptom-based Adjustment|Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
1127021|NCT00495131|B3|Baseline|Total|Total of all reporting groups
1127022|NCT00495131|B2|Baseline|Peginterferon and Ribavirin (48 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
1131366|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
1127024|NCT00495131|P2|Participant Flow|Peginterferon and Ribavirin (48 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
1127025|NCT00495131|P1|Participant Flow|Peginterferon and Ribavirin (24 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
1127026|NCT00495131|O2|Outcome|Peginterferon and Ribavirin (48 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
1127027|NCT00495131|O1|Outcome|Peginterferon and Ribavirin (24 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
1127028|NCT00495131|O2|Outcome|Peginterferon and Ribavirin (48 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
1127029|NCT00495131|O1|Outcome|Peginterferon and Ribavirin (24 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
1127030|NCT00495131|O2|Outcome|Peginterferon and Ribavirin (48 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
1127031|NCT00495131|O1|Outcome|Peginterferon and Ribavirin (24 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
1127032|NCT00495131|O2|Outcome|Peginterferon and Ribavirin (48 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
1127033|NCT00495131|O1|Outcome|Peginterferon and Ribavirin (24 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
1127034|NCT00495079|B1|Baseline|Marqibo|Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).
1127035|NCT00495079|P1|Participant Flow|Marqibo|Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).
1127036|NCT00495079|O1|Outcome|Marqibo|"Proportion if subjects who achieved CR+CRi as determined by the IRRC using the International Working Group (IWG)Criteria. The IRRC Evaluable analysis set(n=53) included subjects who received at least 1 dose of study drug and reviewable data.~Eligible subjects received Marqibo at 2.25mg^m2 intravenously via peripheral or central venous access over 60 minutes (+/-10 minutes) every 7 days (+/-3days)"
1127037|NCT00495079|O1|Outcome|Marqibo|"The population analyzed included all subjects who received at least one dose of Marqibo. Subjects who did not die had their survival times censored on the date of last contact. The K-M method was used to estimate the distribution of overall survival.~Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes)every 7 days (+/- 3 days)"
1127038|NCT00495079|O1|Outcome|Marqibo|"Duration of response derived using the IRRC determined response dates for subjects who achieved CR or CRi (n=8). The K-M product limit method was used to estimate the median event time.~Eligible subjects received Marqibo at 2.25mg^m2 intravenously via peripheral or central venous access over 60 minutes (+- 10 minutes)every 7 days (+/- 3 days)"
1127039|NCT00495079|O1|Outcome|Marqibo|Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).
1127040|NCT00495079|E1|Reported Event|Marqibo|Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).
1127041|NCT00494975|B3|Baseline|Total|Total of all reporting groups
1127042|NCT00494975|B2|Baseline|Narrow Band Ultraviolet B Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVB lamps (TL100W/01 311NB UVB, Philips Company, Eindhoven, The Netherlands).
1127043|NCT00494975|B1|Baseline|Ultraviolet A Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVA lamps (F72T12/BL9/HO UVA, National Biological Corporation, OH, U.S.A. )
1127044|NCT00494975|P2|Participant Flow|Narrow Band Ultraviolet B Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVB lamps (TL100W/01 311NB UVB, Philips Company, Eindhoven, The Netherlands).
1127045|NCT00494975|P1|Participant Flow|Ultraviolet A Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVA lamps (F72T12/BL9/HO UVA, National Biological Corporation, OH, U.S.A. )
1127046|NCT00494975|O2|Outcome|Narrow Band Ultraviolet B Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVB lamps (TL100W/01 311NB UVB, Philips Company, Eindhoven, The Netherlands).
1127047|NCT00494975|O1|Outcome|Ultraviolet A Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVA lamps (F72T12/BL9/HO UVA, National Biological Corporation, OH, U.S.A. )
1127048|NCT00494975|E2|Reported Event|Narrow Band Ultraviolet B Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVB lamps (TL100W/01 311NB UVB, Philips Company, Eindhoven, The Netherlands).
1127049|NCT00494975|E1|Reported Event|Ultraviolet A Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVA lamps (F72T12/BL9/HO UVA, National Biological Corporation, OH, U.S.A. )
1127050|NCT00494871|B3|Baseline|Total|Total of all reporting groups
1127051|NCT00494871|B2|Baseline|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
1127052|NCT00494871|B1|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
1131367|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
1127053|NCT00494871|P2|Participant Flow|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
1127054|NCT00494871|P1|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
1127055|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
1127056|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
1127057|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
1127058|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
1127059|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
1127060|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
1127061|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
1127062|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
1127063|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
1127064|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
1127065|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
1127066|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
1127067|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
1127068|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
1127069|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
1127070|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
1127071|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
1127072|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
1127073|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
1127074|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
1127075|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
1127076|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
1127077|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
1127078|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
1127079|NCT00494871|E4|Reported Event|RG4: Warfarin FU Period|Participants orally administered a warfarin potassium tablet and a rivaroxaban placebo tablet OD during the double-blind treatment period. Safety data collected from last dose plus 2 days to end of trial
1127080|NCT00494871|E3|Reported Event|RG3: Rivaroxaban Follow-up (FU) Period|Participants orally administered a rivaroxaban 15 mg tablet (a 10 mg tablet for participants with creatinine clearance of 30 to 49 mL/min, inclusive, at screening) and a warfarin placebo tablet once daily (OD) during the double-blind treatment period. Safety data collected from last dose plus 2 days to end of trial
1127081|NCT00494871|E2|Reported Event|RG2: Warfarin DB Period|Participants orally administered a warfarin potassium tablet and a rivaroxaban placebo tablet OD during the double-blind treatment period. Safety data collected start with the first dose of study drug up to 2 days after the last dose
1127291|NCT00494221|O3|Outcome|Placebo|FOLFOX + Placebo
1127082|NCT00494871|E1|Reported Event|RG1: Rivaroxaban Double-blind (DB) Period|Participants orally administered a rivaroxaban 15 mg tablet (a 10 mg tablet for participants with creatinine clearance of 30 to 49 mL/min, inclusive, at screening) and a warfarin placebo tablet once daily (OD) during the double-blind treatment period. Safety data collected start with the first dose of study drug up to 2 days after the last dose
1127083|NCT00494806|B3|Baseline|Total|Total of all reporting groups
1127084|NCT00494806|B2|Baseline|Standard Care|Standard care group got out of bed and sat in a non-rocking chair and ambulated beginning the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
1127085|NCT00494806|B1|Baseline|Rocking Chair|Patients rocked in a rocking chair in 10-20 minute increments for at least one hour per day beginning on the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
1127239|NCT00494442|O2|Outcome|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
1131368|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
1127086|NCT00494806|P2|Participant Flow|Standard Care|Standard care group got out of bed and sat in a non-rocking chair and ambulated beginning the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
1127087|NCT00494806|P1|Participant Flow|Rocking Chair|Patients rocked in a rocking chair in 10-20 minute increments for at least one hour per day beginning on the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
1127088|NCT00494806|O2|Outcome|Standard Care|Standard care group got out of bed and sat in a non-rocking chair and ambulated beginning the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
1127089|NCT00494806|O1|Outcome|Rocking Chair|Patients rocked in a rocking chair in 10-20 minute increments for at least one hour per day beginning on the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
1127090|NCT00494806|E2|Reported Event|Standard Care|Standard care group got out of bed and sat in a non-rocking chair and ambulated beginning the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
1127091|NCT00494806|E1|Reported Event|Rocking Chair|Patients rocked in a rocking chair in 10-20 minute increments for at least one hour per day beginning on the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
1127092|NCT00494780|B3|Baseline|Total|Total of all reporting groups
1127093|NCT00494780|B2|Baseline|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127094|NCT00494780|B1|Baseline|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127095|NCT00494780|P2|Participant Flow|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127096|NCT00494780|P1|Participant Flow|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) on Day 3 of each 21-day cycle, with 300 milligrams (mg) in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127097|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127098|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127099|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127100|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127101|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127102|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127103|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127104|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127292|NCT00494221|O2|Outcome|Cediranib 30 mg|FOLFOX + Cediranib 30 mg
1127105|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127106|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127155|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
1133733|NCT00477269|O1|Outcome|STI571|STI571
1127107|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127108|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127109|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127110|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127111|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127112|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127113|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127114|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127115|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127116|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127117|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127118|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127119|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127120|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127121|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127122|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127123|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127124|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127125|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127126|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127127|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127128|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127129|NCT00494780|E4|Reported Event|1000 mg Ofatumumab + CHOP: Extended Follow-up|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127130|NCT00494780|E3|Reported Event|500 mg Ofatumumab + CHOP: Extended Follow-up|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127131|NCT00494780|E2|Reported Event|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127132|NCT00494780|E1|Reported Event|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
1127133|NCT00494676|B1|Baseline|Entire Study Population|Includes groups allocated to receive real prism glasses first and sham prism glasses first
1127134|NCT00494676|P2|Participant Flow|Sham Prism Glasses Then Real|Sham prism glasses for 4 weeks followed by real prism glasses for 4 weeks
1127135|NCT00494676|P1|Participant Flow|Real Prism Glasses Then Sham|Real prism glasses for 4 weeks followed by sham prism glasses for 4 weeks
1127136|NCT00494676|O1|Outcome|Entire Study Population Who Discontinued|Includes groups allocated to receive real prism glasses first and sham prism glasses first
1127137|NCT00494676|O1|Outcome|Entire Study Population Who Continued|Includes groups allocated to receive real prism glasses first and sham prism glasses first
1127138|NCT00494676|O1|Outcome|Entire Study Population|Includes groups allocated to receive real prism glasses first and sham prism glasses first
1127139|NCT00494676|O1|Outcome|Entire Study Population|Includes groups allocated to receive real prism glasses first and sham prism glasses first
1127140|NCT00494676|E1|Reported Event|Entire Study Population|Includes groups allocated to receive real prism glasses first and sham prism glasses first
1127141|NCT00494585|B1|Baseline|CEP-701|80 mg orally twice daily for 30 days
1127142|NCT00494585|P1|Participant Flow|CEP-701|80 mg orally twice daily for 30 days
1127143|NCT00494585|O1|Outcome|CEP-701|80 mg orally twice daily for 30 days
1127144|NCT00494585|E1|Reported Event|CEP-701|80 mg orally twice daily for 30 days
1127145|NCT00494507|B5|Baseline|Total|Total of all reporting groups
1127146|NCT00494507|B4|Baseline|HOP Placebo|"Hypokalemic participants were randomized to Placebo for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
1127147|NCT00494507|B3|Baseline|HOP Dichlorphenamide|"Hypokalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
1127148|NCT00494507|B2|Baseline|HYP Placebo|"Hyperkalemic participants were randomized to Placebo for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
1127149|NCT00494507|B1|Baseline|HYP Dichlorphenamide|"Hyperkalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
1127150|NCT00494507|P4|Participant Flow|HOP Placebo|"Hypokalemic participants were randomized to Placebo for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
1127151|NCT00494507|P3|Participant Flow|HOP Dichlorphenamide|"Hypokalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
1127152|NCT00494507|P2|Participant Flow|HYP Placebo|"Hyperkalemic participants were randomized to Placebo for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
1127153|NCT00494507|P1|Participant Flow|HYP Dichlorphenamide|"Hyperkalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
1127154|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
1127236|NCT00494442|O1|Outcome|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
1127156|NCT00494507|O2|Outcome|HYP Placebo|Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
1127157|NCT00494507|O1|Outcome|HYP Dichlorphenamide|Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
1127158|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
1127159|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
1127160|NCT00494507|O2|Outcome|HYP Placebo|Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
1127161|NCT00494507|O1|Outcome|HYP Dichlorphenamide|Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
1127162|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
1127163|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
1127164|NCT00494507|O2|Outcome|HYP Placebo|Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
1127165|NCT00494507|O1|Outcome|HYP Dichlorphenamide|Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
1127166|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
1127167|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day
1127168|NCT00494507|O2|Outcome|HYP Placebo|Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
1127169|NCT00494507|O1|Outcome|HYP Dichlorphenamide|Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day
1127170|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
1127171|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
1127172|NCT00494507|O2|Outcome|HYP Placebo|Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
1127173|NCT00494507|O1|Outcome|HYP Dichlorphenamide|Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day
1127174|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
1127175|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day
1127176|NCT00494507|O2|Outcome|HYP Placebo|Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet
1127177|NCT00494507|O1|Outcome|HYP Dichlorphenamide|Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day
1127178|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
1127179|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
1127180|NCT00494507|O2|Outcome|HYP Placebo|Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
1127181|NCT00494507|O1|Outcome|HYP Dichlorphenamide|Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
1127182|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
1127183|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
1127184|NCT00494507|O2|Outcome|HYP Placebo|Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
1127185|NCT00494507|O1|Outcome|HYP Dichlorphenamide|Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
1127186|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants were randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
1127187|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
1127237|NCT00494442|O2|Outcome|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
1127188|NCT00494507|O2|Outcome|HYP Placebo|"Hyperkalemic participants were randomized to Placebo for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
1127189|NCT00494507|O1|Outcome|HYP Dichlorphenamide|"Hyperkalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
1127190|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
1127191|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
1127192|NCT00494507|O2|Outcome|HYP Placebo|Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
1127193|NCT00494507|O1|Outcome|HYP Dichlorphenamide|Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
1127194|NCT00494507|E6|Reported Event|HOP Open-Label Dichlorphenamide|Hypokalemic participants received Dichlorphenamide for the 52 week open-label phase.
1127195|NCT00494507|E5|Reported Event|HOP Double-Blind Placebo|Hypokalemic participants were randomized to Placebo for the 9 week double-blind phase.
1127196|NCT00494507|E4|Reported Event|HOP Double-Blind Dichlorphenamide|Hypokalemic participants were randomized to Dichlorphenamide for the 9 week double-blind phase.
1127197|NCT00494507|E3|Reported Event|HYP Open-Label Dichlorphenamide|Hyperkalemic participants received Dichlorphenamide for the 52 week open-label phase.
1127198|NCT00494507|E2|Reported Event|HYP Double-Blind Placebo|Hyperkalemic participants were randomized to Placebo for the 9 week double-blind phase.
1127199|NCT00494507|E1|Reported Event|HYP Double-Blind Dichlorphenamide|Hyperkalemic participants were randomized to Dichlorphenamide for the 9 week double-blind phase.
1127200|NCT00494494|B3|Baseline|Total|Total of all reporting groups
1127201|NCT00494494|B2|Baseline|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
1127202|NCT00494494|B1|Baseline|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
1127203|NCT00494494|P2|Participant Flow|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
1127204|NCT00494494|P1|Participant Flow|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
1127205|NCT00494494|O2|Outcome|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
1127206|NCT00494494|O1|Outcome|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
1127207|NCT00494494|O2|Outcome|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
1127208|NCT00494494|O1|Outcome|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
1127209|NCT00494494|O2|Outcome|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
1127210|NCT00494494|O1|Outcome|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
1127211|NCT00494494|O2|Outcome|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
1127212|NCT00494494|O1|Outcome|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
1127213|NCT00494494|O2|Outcome|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
1127214|NCT00494494|O1|Outcome|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
1127215|NCT00494494|E2|Reported Event|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
1127216|NCT00494494|E1|Reported Event|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
1127217|NCT00494481|B3|Baseline|Total|Total of all reporting groups
1127218|NCT00494481|B2|Baseline|Placebo Plus Docetaxel|placebo plus docetaxel
1127219|NCT00494481|B1|Baseline|Vandetanib Plus Docetaxel|vandetanib 100 mg plus docetaxel
1127220|NCT00494481|P2|Participant Flow|Placebo Plus Docetaxel|placebo plus docetaxel
1127221|NCT00494481|P1|Participant Flow|Vandetanib Plus Docetaxel|vandetanib 100 mg plus docetaxel
1127222|NCT00494481|O2|Outcome|Placebo Plus Docetaxel|placebo plus docetaxel
1127223|NCT00494481|O1|Outcome|Vandetanib Plus Docetaxel|vandetanib 100 mg plus docetaxel
1127224|NCT00494481|E2|Reported Event|Placebo Plus Docetaxel|placebo plus docetaxel
1127225|NCT00494481|E1|Reported Event|Vandetanib Plus Docetaxel|vandetanib 100 mg plus docetaxel
1127226|NCT00494442|B3|Baseline|Total|Total of all reporting groups
1127227|NCT00494442|B2|Baseline|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
1127228|NCT00494442|B1|Baseline|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
1127231|NCT00494442|O2|Outcome|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
1127232|NCT00494442|O1|Outcome|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
1127233|NCT00494442|O2|Outcome|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
1127234|NCT00494442|O1|Outcome|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
1127235|NCT00494442|O2|Outcome|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
1133734|NCT00477269|O2|Outcome|Placebo|Placebo
1127240|NCT00494442|O1|Outcome|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
1127241|NCT00494442|E2|Reported Event|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
1127242|NCT00494442|E1|Reported Event|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
1127243|NCT00494299|B3|Baseline|Total|Total of all reporting groups
1127244|NCT00494299|B2|Baseline|Placebo|Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
1127245|NCT00494299|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
1127246|NCT00494299|P2|Participant Flow|Placebo|Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
1127247|NCT00494299|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
1127248|NCT00494299|O2|Outcome|Placebo|Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
1127249|NCT00494299|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
1127250|NCT00494299|O2|Outcome|Placebo|Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
1127251|NCT00494299|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
1127252|NCT00494299|O2|Outcome|Placebo|Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
1127253|NCT00494299|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
1127254|NCT00494299|E2|Reported Event|Placebo|Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
1127255|NCT00494299|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
1127256|NCT00494234|B3|Baseline|Total|Total of all reporting groups
1127257|NCT00494234|B2|Baseline|AZD2281 400 mg|
1127258|NCT00494234|B1|Baseline|AZD2281 100 mg|
1127259|NCT00494234|P2|Participant Flow|Olaparib 400 mg bd|Full Analysis Set
1127260|NCT00494234|P1|Participant Flow|Olaparib 100 mg bd|Full Analysis Set
1127261|NCT00494234|O2|Outcome|Olaparib 400 mg bd|Patients who compled 6 cycles of treatment
1127262|NCT00494234|O1|Outcome|Olaparib 100 mg bd|Patients who compled 6 cycles of treatment
1127263|NCT00494234|O2|Outcome|Olaparib 400 mg bd|Per Protocol Set
1127264|NCT00494234|O1|Outcome|Olaparib 100 mg bd|Per Protocol Set
1127265|NCT00494234|O2|Outcome|Olaparib 400 mg bd|Per Protocol Set
1127266|NCT00494234|O1|Outcome|Olaparib 100 mg bd|Per Protocol Set
1127267|NCT00494234|O2|Outcome|Olaparib 400 mg bd|Per Protocol Set
1127268|NCT00494234|O1|Outcome|Olaparib 100 mg bd|Per Protocol Set
1127269|NCT00494234|O2|Outcome|Olaparib 400 mg bd|Number of responders
1127270|NCT00494234|O1|Outcome|Olaparib 100 mg bd|Number of responders
1127271|NCT00494234|O2|Outcome|Olaparib 400 mg bd|Per Protocol Set
1127272|NCT00494234|O1|Outcome|Olaparib 100 mg bd|Per Protocol Set
1127273|NCT00494234|E2|Reported Event|AZD2281 400 mg|
1127274|NCT00494234|E1|Reported Event|AZD2281 100 mg|
1127275|NCT00494221|B4|Baseline|Total|Total of all reporting groups
1127276|NCT00494221|B3|Baseline|Placebo|FOLFOX + Placebo
1127277|NCT00494221|B2|Baseline|Cediranib 30 mg|FOLFOX + Cediranib 30 mg
1127278|NCT00494221|B1|Baseline|Cediranib 20 mg|FOLFOX + Cediranib 20 mg
1127279|NCT00494221|P3|Participant Flow|Placebo|FOLFOX + Placebo
1127280|NCT00494221|P2|Participant Flow|Cediranib 30 mg|FOLFOX + Cediranib 30 mg
1127281|NCT00494221|P1|Participant Flow|Cediranib 20 mg|FOLFOX + Cediranib 20 mg
1127282|NCT00494221|O3|Outcome|Placebo|FOLFOX + Placebo
1127283|NCT00494221|O2|Outcome|Cediranib 30 mg|FOLFOX + Cediranib 30 mg
1127284|NCT00494221|O1|Outcome|Cediranib 20 mg|FOLFOX + Cediranib 20 mg
1127285|NCT00494221|O3|Outcome|Placebo|FOLFOX + Placebo
1127286|NCT00494221|O2|Outcome|Cediranib 30 mg|FOLFOX + Cediranib 30 mg
1127287|NCT00494221|O1|Outcome|Cediranib 20 mg|FOLFOX + Cediranib 20 mg
1127288|NCT00494221|O3|Outcome|Placebo|FOLFOX + Placebo
1127289|NCT00494221|O2|Outcome|Cediranib 30 mg|FOLFOX + Cediranib 30 mg
1127300|NCT00494143|B1|Baseline|CESR, Prescribed, Conventional|all subjects were randomized to each of the three interventions
1127301|NCT00494143|P6|Participant Flow|CESR, Conventional, Prescribed|The individuals in this group were randomized to the prosthetic foot sequence, CESR foot, Conventional foot followed by Prescribed prosthetic foot.
1127302|NCT00494143|P5|Participant Flow|CESR, Prescribed, Conventional|This arm included the individuals who were randomized to the prosthetic foot sequence, CESR foot followed by Prescribed foot, followed by Conventional foot.
1127303|NCT00494143|P4|Participant Flow|Prescribed, Conventional, CESR|This arm included individuals who were randomized to the sequence, Prescribed prosthetic foot, conventional foot, CESR foot
1127304|NCT00494143|P3|Participant Flow|Prescribed, CESR, Conventional|The randomized sequence of this arm was the Prescribed prosthetic foot, followed by the CESR foot followed by the Conventional prosthetic foot
1127381|NCT00494013|E2|Reported Event|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
1127305|NCT00494143|P2|Participant Flow|Conventional, CESR, Prescribed|The randomized sequence of prosthetic use in this arm was Conventional foot, followed by CESR foot, followed by Prescribed.
1127306|NCT00494143|P1|Participant Flow|Conventional, Prescribed, CESR|this is a randomized arm where the sequence of prosthetic use was their conventional foot, followed by prescribed foot, followed by the CESR foot
1127307|NCT00494143|O3|Outcome|Prescribed Prosthetic Foot|results while wearing the prescribed prosthetic foot
1127308|NCT00494143|O2|Outcome|Conventional Prosthetic Foot|results while wearing the conventional prosthetic foot
1127309|NCT00494143|O1|Outcome|CESR Experimental Prosthetic Foot|"the CESR, controlled energy storage prosthetic foot~CESR Prosthetic Foot : a novel prosthetic foot that is designed to store energy and release it at a predetermined time in the gait cycle"
1127310|NCT00494143|O3|Outcome|Prescribed Prosthetic Foot|results with prescribed prosthetic foot
1127311|NCT00494143|O2|Outcome|Conventional Prosthetic Foot|results with the conventional prosthetic foot
1127312|NCT00494143|O1|Outcome|CESR Experimental Prosthetic Foot|"the CESR, controlled energy storage prosthetic foot~CESR Prosthetic Foot : a novel prosthetic foot that is designed to store energy and release it at a predetermined time in the gait cycle"
1127313|NCT00494143|O3|Outcome|Prescribed Prosthetic Foot|subjects wearing the prescribed prosthetic foot
1127314|NCT00494143|O2|Outcome|Conventional Prosthetic Foot|subjects wearing the conventional prosthetic foot
1127315|NCT00494143|O1|Outcome|CESR Experimental Prosthetic Foot|"the CESR, controlled energy storage prosthetic foot~CESR Prosthetic Foot : a novel prosthetic foot that is designed to store energy and release it at a predetermined time in the gait cycle"
1127316|NCT00494143|E3|Reported Event|Arm 2 Prescribed Prosthetic Foot|subjects randomized to the prescribed prosthetic foot
1127317|NCT00494143|E2|Reported Event|Arm 1 Conventional Prosthetic Foot|subjects randomized to the conventional prosthetic foot
1127318|NCT00494143|E1|Reported Event|Arm 3 CESR Prosthetic Foot|subjects randomized to the CESR prosthetic foot
1127319|NCT00494091|B3|Baseline|Total|Total of all reporting groups
1127320|NCT00494091|B2|Baseline|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
1127321|NCT00494091|B1|Baseline|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
1127322|NCT00494091|P2|Participant Flow|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
1127323|NCT00494091|P1|Participant Flow|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
1127324|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
1127325|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
1127326|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
1127327|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
1127328|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
1127329|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
1127330|NCT00494091|O2|Outcome|Temsirolimus 25 mg IV|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
1127331|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
1127332|NCT00494091|O2|Outcome|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
1127333|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
1127334|NCT00494091|O2|Outcome|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
1127335|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
1127336|NCT00494091|O2|Outcome|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
1127337|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
1127338|NCT00494091|O2|Outcome|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
1138839|NCT00464438|O2|Outcome|Moxifloxacin 0.5%|
1127339|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
1127340|NCT00494091|O2|Outcome|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
1127341|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
1127342|NCT00494091|E2|Reported Event|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
1127343|NCT00494091|E1|Reported Event|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
1127344|NCT00494026|B1|Baseline|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.~Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
1127345|NCT00494026|P1|Participant Flow|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.~Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
1127346|NCT00494026|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.~Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
1127347|NCT00494026|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.~Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
1127348|NCT00494026|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.~Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
1127349|NCT00494026|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.~Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
1127350|NCT00494026|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.~Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
1127351|NCT00494026|E1|Reported Event|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.~Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
1127352|NCT00494013|B3|Baseline|Total|Total of all reporting groups
1127353|NCT00494013|B2|Baseline|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
1127354|NCT00494013|B1|Baseline|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
1127355|NCT00494013|P2|Participant Flow|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
1127356|NCT00494013|P1|Participant Flow|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
1127357|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
1127358|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
1127359|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
1127360|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
1127361|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
1127362|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
1127363|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
1127364|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
1127365|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
1127366|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
1127367|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
1127368|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
1127369|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
1127370|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
1127371|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
1127372|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
1127373|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
1127374|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
1127375|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
1127376|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
1127377|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
1127378|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
1127379|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
1127380|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
1127382|NCT00494013|E1|Reported Event|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
1127383|NCT00493974|B3|Baseline|Total|Total of all reporting groups
1127384|NCT00493974|B2|Baseline|Placebo|Matching placebo 4 times a day
1127385|NCT00493974|B1|Baseline|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
1127386|NCT00493974|P2|Participant Flow|Placebo|Matching placebo 4 times a day
1127387|NCT00493974|P1|Participant Flow|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
1127388|NCT00493974|O2|Outcome|Placebo|Matching placebo 4 times a day
1127389|NCT00493974|O1|Outcome|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
1127390|NCT00493974|O2|Outcome|Placebo|Matching placebo 4 times a day
1127391|NCT00493974|O1|Outcome|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
1127392|NCT00493974|O2|Outcome|Placebo|Matching placebo 4 times a day
1127393|NCT00493974|O1|Outcome|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
1127394|NCT00493974|O2|Outcome|Placebo|Matching placebo 4 times a day
1127395|NCT00493974|O1|Outcome|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
1127396|NCT00493974|O2|Outcome|Placebo|Matching placebo 4 times a day
1127397|NCT00493974|O1|Outcome|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
1127398|NCT00493974|O2|Outcome|Placebo|Matching placebo 4 times a day
1127399|NCT00493974|O1|Outcome|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
1127400|NCT00493974|O2|Outcome|Placebo|Matching placebo 4 times a day
1127401|NCT00493974|O1|Outcome|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
1127402|NCT00493974|E2|Reported Event|Placebo|Matching placebo 4 times a day
1127403|NCT00493974|E1|Reported Event|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
1127404|NCT00493805|B1|Baseline|Total for Interventional Arm and Non Interventional Arm|
1127405|NCT00493805|P2|Participant Flow|Interventional Arm HOMA IR > 2|Participants in the interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 12-16 weeks until their HCV polymerase chain reaction (PCR) results are available at Week 12. At Week 12, participants with >=2 log decrease of HCV RNA were randomized to continue either for another 36 weeks (Group A- a total of 48 weeks therapy) OR for another 60 weeks (Group B- a total of 72 weeks of therapy) with a 24-week follow up. Randomization was done between Day 1 Week 17 and Day 1 Week 25.
1127406|NCT00493805|P1|Participant Flow|Non Interventional Arm HOMA IR <= 2|Participants in the non-interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) for 48 weeks together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 48 weeks (according to European labeling). Followed by a 24-week follow up period after end of treatment.
1127407|NCT00493805|O2|Outcome|Interventional Arm HOMA IR > 2|Participants in the interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 12-16 weeks until their HCV polymerase chain reaction (PCR) results are available at Week 12. At Week 12, participants with >=2 log decrease of HCV RNA were randomized to continue either for another 36 weeks (Group A- a total of 48 weeks therapy) OR for another 60 weeks (Group B- a total of 72 weeks of therapy) with a 24-week follow up. Randomization was done between Day 1 Week 17 and Day 1 Week 25.
1127408|NCT00493805|O1|Outcome|Non Interventional Arm HOMA IR <= 2|Participants in the non-interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) for 48 weeks together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 48 weeks (according to European labeling). Followed by a 24-week follow up period after end of treatment.
1127409|NCT00493805|O2|Outcome|Interventional Arm HOMA IR > 2|Participants in the interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 12-16 weeks until their HCV polymerase chain reaction (PCR) results are available at Week 12. At Week 12, participants with >=2 log decrease of HCV RNA were randomized to continue either for another 36 weeks (Group A- a total of 48 weeks therapy) OR for another 60 weeks (Group B- a total of 72 weeks of therapy) with a 24-week follow up. Randomization was done between Day 1 Week 17 and Day 1 Week 25.
1127410|NCT00493805|O1|Outcome|Non Interventional Arm HOMA IR <= 2|Participants in the non-interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) for 48 weeks together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 48 weeks (according to European labeling). Followed by a 24-week follow up period after end of treatment.
1127411|NCT00493805|E2|Reported Event|Interventional Arm HOMA IR >2|
1127413|NCT00493779|B1|Baseline|Clopidogrel Withdrawal Population|All enrolled participants in whom clopidogrel treatment was discontinued.
1127414|NCT00493779|P1|Participant Flow|Clopidogrel Withdrawal Population|All enrolled participants in whom clopidogrel treatment was discontinued.
1127415|NCT00493779|O1|Outcome|Clopidogrel Withdrawal Population|All enrolled participants in whom clopidogrel treatment was discontinued.
1127416|NCT00493779|O1|Outcome|Biomarker Analysis Population|All participants in the Clopidogrel Withdrawal Population having a baseline and at least one post clopidogrel withdrawal measurement for any of the 3 biomarkers collected.
1127417|NCT00493779|O1|Outcome|Biomarker Analysis Population|All participants in the Clopidogrel Withdrawal Population having a baseline and at least one post clopidogrel withdrawal measurement for any of the 3 biomarkers collected.
1127418|NCT00493779|O1|Outcome|Biomarker Analysis Population|All participants in the Clopidogrel Withdrawal Population having a baseline and at least one post clopidogrel withdrawal measurement for any of the 3 biomarkers collected.
1127419|NCT00493779|E1|Reported Event|Clopidogrel Withdrawal Population|All enrolled participants in whom clopidogrel treatment was discontinued.
1127420|NCT00493649|B1|Baseline|TC+H|docetaxel (Taxotere), plus cyclophosphamide (Cytoxan), plus weekly trastuzumab (Herceptin)
1127421|NCT00493649|P1|Participant Flow|TC+H|This is a nonrandomized, noncomparative, open-label Phase II study. On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive docetaxel (Taxotere) 75 mg/m^2 IV plus cyclophosphamide (Cytoxan) 600 mg/m^2 IV, plus weekly trastuzumab (Herceptin) 4 mg/kg IV (loading dose, Day 1, Cycle 1 only) and 2 mg/kg IV (on Days 1, 8, and 15) thereafter. Subsequent cycles of therapy will continue until a total of 4 cycles of TC+H have been completed. Then, patients will continue to receive trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care.
1127422|NCT00493649|O2|Outcome|cMYC-nonamplified Group|FISH ratio of cMYC gene copy number was less than 2.
1127423|NCT00493649|O1|Outcome|cMYC-amplified Group|FISH ratio of cMYC gene copy number was 2 or greater.
1127424|NCT00493649|O2|Outcome|cMYC-nonamplified Group|FISH ratio of cMYC gene copy number was less than 2.
1127425|NCT00493649|O1|Outcome|cMYC-amplified Group|FISH ratio of cMYC gene copy number was 2 or greater.
1127426|NCT00493649|O2|Outcome|TOP2A-nonamplified Group|FISH ratio of TOP2A gene copy number was less than 2.
1127427|NCT00493649|O1|Outcome|TOP2A-amplified Group|FISH ratio of TOP2A gene copy number was 2 or greater.
1127428|NCT00493649|O2|Outcome|TOP2A-nonamplified Group|FISH ratio of TOP2A gene copy number was less than 2.
1127429|NCT00493649|O1|Outcome|TOP2A-amplified Group|FISH ratio of TOP2A gene copy number was 2 or greater.
1127430|NCT00493649|E1|Reported Event|TC+H|docetaxel (Taxotere), plus cyclophosphamide (Cytoxan), plus weekly trastuzumab (Herceptin)
1127431|NCT00493636|B3|Baseline|Total|Total of all reporting groups
1127432|NCT00493636|B2|Baseline|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
1127433|NCT00493636|B1|Baseline|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
1127434|NCT00493636|P2|Participant Flow|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
1127435|NCT00493636|P1|Participant Flow|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
1127436|NCT00493636|O2|Outcome|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
1128091|NCT00492232|P2|Participant Flow|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
1127437|NCT00493636|O1|Outcome|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
1127488|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127828|NCT00493012|B1|Baseline|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
1127438|NCT00493636|O2|Outcome|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
1127439|NCT00493636|O1|Outcome|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
1127440|NCT00493636|O2|Outcome|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
1127441|NCT00493636|O1|Outcome|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
1127442|NCT00493636|O2|Outcome|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
1127443|NCT00493636|O1|Outcome|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
1127444|NCT00493636|O2|Outcome|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
1127445|NCT00493636|O1|Outcome|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
1127483|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127446|NCT00493636|E2|Reported Event|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
1127447|NCT00493636|E1|Reported Event|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
1127448|NCT00493454|B1|Baseline|Ibritumomab Tiuxetan + Rituximab|Rituximab 250 mg/m² intravenous (IV) Days 1 and 8, 111In Ibritumomab Tiuxetan (5mCi of 111In, 1.6 mg of Ibritumomab Tiuxetan) IV (over 10 minutes) on Day 1; and 90Y Ibritumomab Tiuxetan 0.3 or 0.4 mCi/kg IV (over 10 minutes) on Day 8 after the Day 8 of Rituximab.
1127449|NCT00493454|P1|Participant Flow|Ibritumomab Tiuxetan + Rituximab|Rituximab 250 mg/m² intravenous (IV) Days 1 and 8, 111In Ibritumomab Tiuxetan (5mCi of 111In, 1.6 mg of Ibritumomab Tiuxetan) IV (over 10 minutes) on Day 1; and 90Y Ibritumomab Tiuxetan 0.3 or 0.4 mCi/kg IV (over 10 minutes) on Day 8 after the Day 8 of Rituximab.
1127450|NCT00493454|O1|Outcome|Ibritumomab Tiuxetan + Rituximab|Rituximab 250 mg/m² intravenous (IV) Days 1 and 8, 111In Ibritumomab Tiuxetan (5mCi of 111In, 1.6 mg of Ibritumomab Tiuxetan) IV (over 10 minutes) on Day 1; and 90Y Ibritumomab Tiuxetan 0.3 or 0.4 mCi/kg IV (over 10 minutes) on Day 8 after the Day 8 of Rituximab.
1127451|NCT00493454|E1|Reported Event|Ibritumomab Tiuxetan + Rituximab|Rituximab 250 mg/m² intravenous (IV) Days 1 and 8, 111In Ibritumomab Tiuxetan (5mCi of 111In, 1.6 mg of Ibritumomab Tiuxetan) IV (over 10 minutes) on Day 1; and 90Y Ibritumomab Tiuxetan 0.3 or 0.4 mCi/kg IV (over 10 minutes) on Day 8 after the Day 8 of Rituximab.
1127452|NCT00493311|B3|Baseline|Total|Total of all reporting groups
1127453|NCT00493311|B2|Baseline|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
1127454|NCT00493311|B1|Baseline|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
1127455|NCT00493311|P2|Participant Flow|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
1127456|NCT00493311|P1|Participant Flow|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
1127457|NCT00493311|O2|Outcome|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
1127458|NCT00493311|O1|Outcome|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
1127459|NCT00493311|O2|Outcome|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
1127460|NCT00493311|O1|Outcome|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
1127461|NCT00493311|O2|Outcome|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
1127462|NCT00493311|O1|Outcome|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
1127463|NCT00493311|O2|Outcome|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
1127464|NCT00493311|O1|Outcome|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
1127465|NCT00493311|O2|Outcome|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
1127466|NCT00493311|O1|Outcome|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
1127467|NCT00493311|E2|Reported Event|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
1127468|NCT00493311|E1|Reported Event|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
1127469|NCT00493285|B7|Baseline|TOTAL|Total of all reporting groups
1127470|NCT00493285|B6|Baseline|10^6 PLACEBO|
1127471|NCT00493285|B5|Baseline|10^6 MEDI-534|
1127472|NCT00493285|B4|Baseline|10^5 PLACEBO|
1127473|NCT00493285|B3|Baseline|10^5 MEDI-534|
1127474|NCT00493285|B2|Baseline|10^4 PLACEBO|
1127475|NCT00493285|B1|Baseline|10^4 MEDI-534|
1127476|NCT00493285|P6|Participant Flow|10^6 PLACEBO|
1127477|NCT00493285|P5|Participant Flow|10^6 MEDI-534|
1127478|NCT00493285|P4|Participant Flow|10^5 PLACEBO|
1127479|NCT00493285|P3|Participant Flow|10^5 MEDI-534|
1127480|NCT00493285|P2|Participant Flow|10^4 PLACEBO|
1127481|NCT00493285|P1|Participant Flow|10^4 MEDI-534|
1127482|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127484|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127485|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127486|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127487|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127489|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127490|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127491|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127492|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127493|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127494|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127495|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127496|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127497|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127498|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127499|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127500|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127501|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127502|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127503|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127504|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127505|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127506|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127507|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127508|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127509|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127510|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127511|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127512|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127513|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127514|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127515|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127516|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127517|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127518|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127554|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127519|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127520|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127521|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127522|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127594|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127523|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127524|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127525|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127526|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127527|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127528|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127529|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127530|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127531|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127532|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127533|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127534|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127535|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127536|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127537|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127538|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127539|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127540|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127541|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127542|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127543|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127544|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127545|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127546|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127547|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127548|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127549|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127550|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127551|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127552|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127553|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1128132|NCT00492089|B1|Baseline|Arm A: Bevacizumab|Bevacizumab 7.5 mg/m^2 intravenous (IV) every 3 weeks
1127555|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127556|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127557|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127558|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127559|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127560|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127561|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127562|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127563|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127564|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127565|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127566|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127567|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127568|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127569|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127570|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127571|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127572|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127573|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127574|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127575|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127576|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127577|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127578|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127579|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127580|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127581|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127582|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127583|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127584|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127585|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127586|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127587|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127588|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127589|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1128185|NCT00492024|E2|Reported Event|Placebo|Matching placebo for 5 days
1127590|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127591|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127592|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127593|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127595|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127596|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127597|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127598|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127599|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127600|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127601|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127602|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127603|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127604|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127605|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127606|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127607|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127608|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127609|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127610|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127611|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127612|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127613|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127614|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127615|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127616|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127617|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127618|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127619|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127620|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127621|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127622|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127623|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127624|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127660|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127625|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127626|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127627|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127628|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127704|NCT00493246|B9|Baseline|Total|Total of all reporting groups
1127829|NCT00493012|P2|Participant Flow|Placebo Comparator|A daily placebo oil is given for year
1127629|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127630|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127631|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127632|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127633|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127634|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127635|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127636|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127637|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127638|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127639|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127640|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127641|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127642|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127643|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127644|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127645|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127646|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127647|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127648|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127649|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127650|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127651|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127652|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127653|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127654|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127655|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127656|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127657|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127658|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127659|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1128186|NCT00492024|E1|Reported Event|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
1127661|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127662|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127663|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127664|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127665|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127666|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127667|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127668|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127669|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127670|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127671|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127672|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127673|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127674|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127675|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127676|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127677|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127678|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127679|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127680|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127681|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127682|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127683|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127684|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127685|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127686|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127687|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127688|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127689|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127690|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127691|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127692|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127693|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127694|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127695|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1128502|NCT00490945|E5|Reported Event|100 mg VEC-162|Randomized to 100 mg VEC-162
1127696|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
1127697|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
1127698|NCT00493285|E6|Reported Event|10^6 PLACEBO|
1127699|NCT00493285|E5|Reported Event|10^6 MEDI-534|
1127700|NCT00493285|E4|Reported Event|10^5 PLACEBO|
1127701|NCT00493285|E3|Reported Event|10^5 MEDI-534|
1127702|NCT00493285|E2|Reported Event|10^4 PLACEBO|
1127703|NCT00493285|E1|Reported Event|10^4 MEDI-534|
1127705|NCT00493246|B8|Baseline|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127706|NCT00493246|B7|Baseline|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127707|NCT00493246|B6|Baseline|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127708|NCT00493246|B5|Baseline|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127709|NCT00493246|B4|Baseline|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127710|NCT00493246|B3|Baseline|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127711|NCT00493246|B2|Baseline|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
1127712|NCT00493246|B1|Baseline|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
1127713|NCT00493246|P8|Participant Flow|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127714|NCT00493246|P7|Participant Flow|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127715|NCT00493246|P6|Participant Flow|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127716|NCT00493246|P5|Participant Flow|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127717|NCT00493246|P4|Participant Flow|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127718|NCT00493246|P3|Participant Flow|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127719|NCT00493246|P2|Participant Flow|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
1127720|NCT00493246|P1|Participant Flow|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
1127721|NCT00493246|O8|Outcome|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127722|NCT00493246|O7|Outcome|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127723|NCT00493246|O6|Outcome|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127724|NCT00493246|O5|Outcome|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127725|NCT00493246|O4|Outcome|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127726|NCT00493246|O3|Outcome|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127727|NCT00493246|O2|Outcome|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
1128092|NCT00492232|P1|Participant Flow|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
1127728|NCT00493246|O1|Outcome|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
1127729|NCT00493246|O8|Outcome|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127730|NCT00493246|O7|Outcome|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1131369|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
1127731|NCT00493246|O6|Outcome|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127732|NCT00493246|O5|Outcome|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127733|NCT00493246|O4|Outcome|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127734|NCT00493246|O3|Outcome|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127735|NCT00493246|O2|Outcome|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
1127736|NCT00493246|O1|Outcome|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
1127737|NCT00493246|O8|Outcome|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127738|NCT00493246|O7|Outcome|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127739|NCT00493246|O6|Outcome|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127740|NCT00493246|O5|Outcome|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127741|NCT00493246|O4|Outcome|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127742|NCT00493246|O3|Outcome|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127743|NCT00493246|O2|Outcome|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
1127744|NCT00493246|O1|Outcome|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
1127745|NCT00493246|O8|Outcome|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127746|NCT00493246|O7|Outcome|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127747|NCT00493246|O6|Outcome|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127748|NCT00493246|O5|Outcome|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127749|NCT00493246|O4|Outcome|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127750|NCT00493246|O3|Outcome|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127751|NCT00493246|O2|Outcome|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
1127752|NCT00493246|O1|Outcome|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
1127753|NCT00493246|O8|Outcome|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127754|NCT00493246|O7|Outcome|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1128093|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
1127755|NCT00493246|O6|Outcome|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127756|NCT00493246|O5|Outcome|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127785|NCT00493220|P5|Participant Flow|IV, HYLENEX SC, Placebo SC|intravenous ceftriaxone as first intervention, subcutaneous HYLENEX and ceftriaxone as second intervention, subcutaneous placebo and ceftriaxone as third intervention
1127757|NCT00493246|O4|Outcome|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127758|NCT00493246|O3|Outcome|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127759|NCT00493246|O2|Outcome|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
1127760|NCT00493246|O1|Outcome|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
1127761|NCT00493246|O8|Outcome|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127762|NCT00493246|O7|Outcome|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127763|NCT00493246|O6|Outcome|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127764|NCT00493246|O5|Outcome|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127765|NCT00493246|O4|Outcome|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127766|NCT00493246|O3|Outcome|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127767|NCT00493246|O2|Outcome|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
1127768|NCT00493246|O1|Outcome|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
1127769|NCT00493246|E8|Reported Event|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127770|NCT00493246|E7|Reported Event|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127771|NCT00493246|E6|Reported Event|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127772|NCT00493246|E5|Reported Event|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127773|NCT00493246|E4|Reported Event|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127774|NCT00493246|E3|Reported Event|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
1127775|NCT00493246|E2|Reported Event|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
1127776|NCT00493246|E1|Reported Event|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
1127777|NCT00493220|B7|Baseline|Total|Total of all reporting groups
1127778|NCT00493220|B6|Baseline|IV, Placebo SC, HYLENEX SC|intravenous ceftriaxone as first intervention, subcutaneous placebo and ceftriaxone as second intervention, subcutaneous HYLENEX and ceftriaxone as third intervention
1127779|NCT00493220|B5|Baseline|IV, HYLENEX SC, Placebo SC|intravenous ceftriaxone as first intervention, subcutaneous HYLENEX and ceftriaxone as second intervention, subcutaneous placebo and ceftriaxone as third intervention
1127780|NCT00493220|B4|Baseline|Placebo SC, IV, HYLENEX SC|subcutaneous placebo and ceftriaxone as first intervention, intravenous ceftriaxone as second intervention, subcutaneous HYLENEX and ceftriaxone as third intervention
1127781|NCT00493220|B3|Baseline|Placebo SC, HYLENEX SC, IV|subcutaneous placebo and ceftriaxone as first intervention, subcutaneous HYLENEX and ceftriaxone as second intervention, intravenous ceftriaxone as third intervention
1127782|NCT00493220|B2|Baseline|HYLENEX SC, IV, Placebo SC|subcutaneous HYLENEX and ceftriaxone as first intervention, intravenous ceftriaxone as second intervention, subcutaneous placebo and ceftriaxone as third intervention
1127944|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
1127783|NCT00493220|B1|Baseline|HYLENEX SC, Placebo SC, IV|subcutaneous HYLENEX and ceftriaxone as first intervention, subcutaneous placebo and ceftriaxone as second intervention, intravenous ceftriaxone as third intervention
1127784|NCT00493220|P6|Participant Flow|IV, Placebo SC, HYLENEX SC|intravenous ceftriaxone as first intervention, subcutaneous placebo and ceftriaxone as second intervention, subcutaneous HYLENEX and ceftriaxone as third intervention
1127826|NCT00493012|B3|Baseline|Total|Total of all reporting groups
1127786|NCT00493220|P4|Participant Flow|Placebo SC, IV, HYLENEX SC|subcutaneous placebo and ceftriaxone as first intervention, intravenous ceftriaxone as second intervention, subcutaneous HYLENEX and ceftriaxone as third intervention
1127787|NCT00493220|P3|Participant Flow|Placebo SC, HYLENEX SC, IV|subcutaneous placebo and ceftriaxone as first intervention, subcutaneous HYLENEX and ceftriaxone as second intervention, intravenous ceftriaxone as third intervention
1127788|NCT00493220|P2|Participant Flow|HYLENEX SC, IV, Placebo SC|subcutaneous HYLENEX and ceftriaxone as first intervention, intravenous ceftriaxone as second intervention, subcutaneous placebo and ceftriaxone as third intervention
1127789|NCT00493220|P1|Participant Flow|HYLENEX SC, Placebo SC, IV|subcutaneous HYLENEX and ceftriaxone as first intervention, subcutaneous placebo and ceftriaxone as second intervention, intravenous ceftriaxone as third intervention
1127790|NCT00493220|O3|Outcome|Intravenous|All per-protocol participants administered intravenous ceftriaxone
1127791|NCT00493220|O2|Outcome|Placebo SC|All per-protocol participants administered subcutaneous placebo and ceftriaxone
1127792|NCT00493220|O1|Outcome|HYLENEX SC|All per-protocol participants administered subcutaneous HYLENEX and ceftriaxone
1127793|NCT00493220|O3|Outcome|Intravenous|All per-protocol participants administered intravenous ceftriaxone
1127794|NCT00493220|O2|Outcome|Placebo SC|All per-protocol participants administered subcutaneous placebo and ceftriaxone
1127795|NCT00493220|O1|Outcome|HYLENEX SC|All per-protocol participants administered subcutaneous HYLENEX and ceftriaxone
1127796|NCT00493220|O3|Outcome|Intravenous|All per-protocol participant administered intravenous ceftriaxone
1127797|NCT00493220|O2|Outcome|Placebo SC|All per-protocol participants administered subcutaneous placebo and ceftriaxone
1127798|NCT00493220|O1|Outcome|HYLENEX SC|All per-protocol participants administered subcutaneous HYLENEX and ceftriaxone
1127799|NCT00493220|O3|Outcome|Intravenous|All per-protocol participants administered intravenous ceftriaxone
1127800|NCT00493220|O2|Outcome|Placebo SC|All per-protocol participants administered subcutaneous placebo and ceftriaxone
1127801|NCT00493220|O1|Outcome|HYLENEX SC|All per-protocol participants administered subcutaneous hylenex and ceftriaxone
1127802|NCT00493220|E3|Reported Event|Intravenous|All participants administered intravenous ceftriaxone
1127803|NCT00493220|E2|Reported Event|Placebo SC|All participants administered subcutaneous placebo and ceftriaxone
1127804|NCT00493220|E1|Reported Event|HYLENEX SC|All participants administered subcutaneous HYLENEX and ceftriaxone
1127805|NCT00493181|B1|Baseline|Interleukin-11|Starting dose 10 mcg/kg subcutaneously 3 times a week
1127806|NCT00493181|P1|Participant Flow|Interleukin-11|Starting dose 10 mcg/kg subcutaneously 3 times a week
1127807|NCT00493181|O1|Outcome|Interleukin-11|Starting dose 10 mcg/kg subcutaneously 3 times a week
1127808|NCT00493181|E1|Reported Event|Interleukin-11|Starting dose 10 mcg/kg subcutaneously 3 times a week
1127809|NCT00493038|B3|Baseline|Total|Total of all reporting groups
1127810|NCT00493038|B2|Baseline|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
1127811|NCT00493038|B1|Baseline|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
1127812|NCT00493038|P2|Participant Flow|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
1127813|NCT00493038|P1|Participant Flow|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
1127814|NCT00493038|O2|Outcome|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
1127815|NCT00493038|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
1127816|NCT00493038|O2|Outcome|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
1127817|NCT00493038|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
1127818|NCT00493038|O2|Outcome|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
1127819|NCT00493038|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
1127820|NCT00493038|O2|Outcome|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
1127821|NCT00493038|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
1127822|NCT00493038|O2|Outcome|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
1128094|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
1127823|NCT00493038|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
1127824|NCT00493038|E2|Reported Event|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
1127825|NCT00493038|E1|Reported Event|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
1127830|NCT00493012|P1|Participant Flow|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
1127831|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
1127832|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
1127833|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
1127834|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
1127835|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
1127836|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
1127837|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
1127838|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
1127839|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
1127840|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
1127841|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
1127842|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
1127843|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
1127844|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
1127845|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
1127846|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
1127847|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
1127848|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
1127849|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
1127850|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
1127851|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
1127852|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
1127853|NCT00493012|E2|Reported Event|Placebo Comparator|A daily placebo oil is given for year
1127854|NCT00493012|E1|Reported Event|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
1127855|NCT00492973|B3|Baseline|Total|Total of all reporting groups
1127856|NCT00492973|B2|Baseline|Corticosteroid|"Corticosteroid (methylprednisolone acetate)~methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
1127857|NCT00492973|B1|Baseline|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.~active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
1127858|NCT00492973|P2|Participant Flow|Corticosteroid|"Corticosteroid (methylprednisolone acetate)~methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
1127859|NCT00492973|P1|Participant Flow|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.~active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
1127860|NCT00492973|O2|Outcome|Corticosteroid|"Corticosteroid (methylprednisolone acetate)~methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
1127861|NCT00492973|O1|Outcome|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.~active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
1127862|NCT00492973|O2|Outcome|Corticosteroid|"Corticosteroid (methylprednisolone acetate)~methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
1127863|NCT00492973|O1|Outcome|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.~active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
1127864|NCT00492973|O2|Outcome|Corticosteroid|"Corticosteroid (methylprednisolone acetate)~methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
1127941|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
1127865|NCT00492973|O1|Outcome|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.~active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
1127866|NCT00492973|O2|Outcome|Corticosteroid|"Corticosteroid (methylprednisolone acetate)~methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
1127867|NCT00492973|O1|Outcome|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.~active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
1127950|NCT00492726|E2|Reported Event|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
1127868|NCT00492973|O2|Outcome|Corticosteroid|"Corticosteroid (methylprednisolone acetate)~methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
1127869|NCT00492973|O1|Outcome|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.~active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
1127870|NCT00492973|E2|Reported Event|Corticosteroid|"Corticosteroid (methylprednisolone acetate)~methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
1127871|NCT00492973|E1|Reported Event|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.~active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
1127872|NCT00492856|B1|Baseline|Low and Intermediate Risk APL Patients|All patients received induction: ATRA 45 mg/m^2/day orally, divided BID, Ara-C 200 mg/m^2/day continuous IV infusion days 3-9, Daunorubicin 50 mg/m^2/day IV bolus days 3-6. If CR (CRm), CRi, or PR, patients received consolidation: Arsenic trioxide 0.15 mg/kg/day IV infusion over 2 hours, 5 days per week for 5 weeks followed by 2 weeks of rest (2 courses). ATRA 45 mg/m^2/day orally divided BID days 1-7, Daunorubicin 50 mg/m^2/day IV bolus days 1-3 (2 courses). If CRm, patients randomized to either (1) maintenance: ATRA 45 mg/m^2/day orally divided BID 7 days repeated every other week, 6-MP 60 mg/m^2/day orally daily, Methotrexate 20 mg/m^2 orally once a week (1 year cycle), or (2) observation. If CR or CRi, but not CRm, patients received maintenance gemtuzumab ozogamicin 6 mg/m^2/day IV over 2 hours days 1 and 15 (up to 6 does). Effective with Revision #6, all eligible patients were non-randomly assigned to receive maintenance with ATRA, 6-MP, and MTX.
1127873|NCT00492856|P4|Participant Flow|Post-consolidation Gemtuzumab Ozogamicin|Patients who did not achieve CRm, but achieved CR/CRi and are PML-RARα-positive after consolidation received maintenance gemtuzumab ozogamicin 6 mg/m^2/day IV over 2 hours days 1 and 15 (up to 6 does).
1127874|NCT00492856|P3|Participant Flow|Post-consolidation Observation|Patients who achieved CRm after consolidation and were randomized to the observation arm.
1127875|NCT00492856|P2|Participant Flow|Post-consolidation ATRA, 6-MP, MTX|Patients who achieved CRm after consolidation and were randomized or assigned to the treatment arm received ATRA 45 mg/m^2/day orally divided BID 7 days repeated every other week, 6-MP 60 mg/m^2/day orally daily, Methotrexate 20 mg/m^2 orally once a week (1 year cycle). Effective with Revision #6, all eligible patients were non-randomly assigned to receive maintenance with ATRA, 6-MP, and MTX.
1127876|NCT00492856|P1|Participant Flow|Low and Intermediate Risk APL Patients|All patients received induction: ATRA 45 mg/m^2/day orally, divided BID, Ara-C 200 mg/m^2/day continuous IV infusion days 3-9, Daunorubicin 50 mg/m^2/day IV bolus days 3-6. If CR (CRm), CRi, or PR, patients received consolidation: Arsenic trioxide 0.15 mg/kg/day IV infusion over 2 hours, 5 days per week for 5 weeks followed by 2 weeks of rest (2 courses). ATRA 45 mg/m^2/day orally divided BID days 1-7, Daunorubicin 50 mg/m^2/day IV bolus days 1-3 (2 courses).
1127877|NCT00492856|O2|Outcome|Post-consolidation Therapy Arm II|Patients receive no further chemotherapy. (Randomization and observation arm closed as of 05/27/10)
1127878|NCT00492856|O1|Outcome|Post-consolidation Therapy Arm I|"Patients receive oral tretinoin twice daily on days 1-7, oral mercaptopurine once daily on days 1-14, and oral methotrexate on day 1. Treatment repeats every 2 weeks for up to 1 year.~mercaptopurine: Given orally~methotrexate: Given orally~tretinoin: Given orally"
1127879|NCT00492856|O4|Outcome|Gemtuzumab Ozogamicin|Gemtuzumab Ozogamicin 6 mg/m^2/day IV over 2 hours days 1 and 15 (up to 6 does)
1127880|NCT00492856|O3|Outcome|ATRA+6-MP+MTX|ATRA 45 mg/m^2/day orally divided BID 7 days repeated every other week, 6-MP 60 mg/m^2/day orally daily, Methotrexate 20 mg/m^2 orally once a week (1 year cycle).
1127881|NCT00492856|O2|Outcome|Consolidation|Arsenic trioxide 0.15 mg/kg/day IV infusion over 2 hours, 5 days per week for 5 weeks followed by 2 weeks of rest (2 courses). ATRA 45 mg/m^2/day orally divided BID days 1-7, Daunorubicin 50 mg/m^2/day IV bolus days 1-3 (2 courses).
1127882|NCT00492856|O1|Outcome|ATRA + Ara-C + Daunorubicin|ATRA 45 mg/m^2/day orally, divided BID, Ara-C 200 mg/m^2/day continuous IV infusion days 3-9, Daunorubicin 50 mg/m^2/day IV bolus days 3-6
1127883|NCT00492856|E4|Reported Event|Gemtuzumab Ozogamicin|Gemtuzumab Ozogamicin 6 mg/m^2/day IV over 2 hours days 1 and 15 (up to 6 does)
1127884|NCT00492856|E3|Reported Event|ATRA+6-MP+MTX|ATRA 45 mg/m^2/day orally divided BID 7 days repeated every other week, 6-MP 60 mg/m^2/day orally daily, Methotrexate 20 mg/m^2 orally once a week (1 year cycle).
1127885|NCT00492856|E2|Reported Event|Consolidation|Arsenic trioxide 0.15 mg/kg/day IV infusion over 2 hours, 5 days per week for 5 weeks followed by 2 weeks of rest (2 courses). ATRA 45 mg/m^2/day orally divided BID days 1-7, Daunorubicin 50 mg/m^2/day IV bolus days 1-3 (2 courses).
1127886|NCT00492856|E1|Reported Event|ATRA + Ara-C + Daunorubicin|ATRA 45 mg/m^2/day orally, divided BID, Ara-C 200 mg/m^2/day continuous IV infusion days 3-9, Daunorubicin 50 mg/m^2/day IV bolus days 3-6
1127887|NCT00492752|B3|Baseline|Total|Total of all reporting groups
1127888|NCT00492752|B2|Baseline|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
1127942|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
1128095|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
1127889|NCT00492752|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
1127890|NCT00492752|P4|Participant Flow|B2) Placebo First - Then Open Label Sorafenib Treatment Phase|"Participants switched to Open-label Sorafenib treatment from Placebo after unblinding (August 19, 2007), Sorafenib administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.~Note: Safety Data of participants in the arm presented here are the data reported in Reporting Group (RG) 3."
1127891|NCT00492752|P3|Participant Flow|B1) Placebo - no Open Label Phase|"Participants randomized to Sorafenib-matching Placebo until unblinding (August 19, 2007), Placebo tablets matching in appearance were orally administered twice daily (bid).~Note: Safety Data of participants in the arm presented here are part of the data reported in Reporting Group (RG) 2."
1127892|NCT00492752|P2|Participant Flow|A2) Sorafenib (Nexavar, BAY43-9006) - With Open Label Phase|"Participants randomized to Sorafenib treatment from until unblinding (August 19, 2007) until end of trial (July 27, 2009), Sorafenib administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.~Note: Safety Data of participants in the arm presented here are part of the data reported in Reporting Group (RG) 1."
1127893|NCT00492752|P1|Participant Flow|A1) Sorafenib (Nexavar, BAY43-9006) - no Open Label Phase|"Participants randomized to Sorafenib treatment until unblinding (August 19, 2007), Sorafenib administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.~Note: Safety Data of participants in the arm presented here are part of the data reported in Reporting Group (RG) 1."
1127894|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
1127895|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
1127896|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
1127897|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
1127898|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
1127899|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
1127900|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
1127901|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
1127902|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
1127903|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
1127904|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
1127905|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
1127906|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
1127907|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
1127908|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
1127909|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
1127910|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
1127911|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
1127912|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
1127943|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
1127913|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
1127914|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
1127915|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
1127916|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
1127917|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
1127918|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
1127919|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
1127920|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
1127921|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
1127922|NCT00492752|E3|Reported Event|Placebo, Open Label Only (Participants Switched to Sorafenib)|Reporting Group 3 (RG 3): Participants switched to Open-label Sorafenib treatment from Placebo ( Data after unblinding [August 19, 2007] until end of this trial [July 27, 2009]). Sorafenib administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
1127923|NCT00492752|E2|Reported Event|Placebo, All (Double-Blind and Open Label Phase)|Reporting Group 2 (RG 2): All participants randomized to Sorafenib-matching Placebo (data from start of treatment until end of trial [July 27, 2009]). Treatment for Double-Blind phase (before unblinding [August 19, 2007]): Placebo tablets matching in appearance were orally administered twice daily (bid); Treatment for Open Label phase (after unblinding [August 19, 2007]): Sorafenib administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
1127924|NCT00492752|E1|Reported Event|Sorafenib, All (Double-Blind and Open Label Phase)|Reporting Group 1 (RG 1): All participants randomized to Sorafenib treatment (data from start of treatment until end of trial [July 27, 2009]). Sorafenib administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
1127925|NCT00492726|B3|Baseline|Total|Total of all reporting groups
1127926|NCT00492726|B2|Baseline|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
1127927|NCT00492726|B1|Baseline|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
1127928|NCT00492726|P2|Participant Flow|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
1127929|NCT00492726|P1|Participant Flow|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
1127930|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
1127931|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
1127932|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
1127933|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
1127934|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
1127935|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
1127936|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
1127937|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
1127938|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
1127939|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
1127940|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
1127945|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
1127946|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
1127947|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
1127948|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
1127949|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
1127951|NCT00492726|E1|Reported Event|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
1127952|NCT00492583|B3|Baseline|Total|Total of all reporting groups
1127953|NCT00492583|B2|Baseline|Bifidobacterium Lactis (BB-12)|
1127954|NCT00492583|B1|Baseline|Placebo|
1127955|NCT00492583|P2|Participant Flow|Bifidobacterium Lactis (BB-12)|
1127956|NCT00492583|P1|Participant Flow|Placebo|
1127957|NCT00492583|O2|Outcome|Bifidobacterium Lactis (BB-12)|
1127958|NCT00492583|O1|Outcome|Placebo|
1127959|NCT00492583|E2|Reported Event|Bifidobacterium Lactis (BB-12)|
1127960|NCT00492583|E1|Reported Event|Placebo|
1127961|NCT00492557|B3|Baseline|Total|Total of all reporting groups
1127962|NCT00492557|B2|Baseline|Placebo+TIV Followed by 13vPnC 1 Month Later|Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM, followed by a single 0.5 mL 13vPnC, 1 month later.
1127963|NCT00492557|B1|Baseline|13vPnC+TIV Followed by Placebo 1 Month Later|Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM), followed by a single 0.5 mL 13vPnC placebo vaccine, 1 month later.
1127964|NCT00492557|P2|Participant Flow|Placebo+TIV Followed by 13vPnC 1 Month Later|Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM, followed by a single 0.5 mL 13vPnC, 1 month later.
1127965|NCT00492557|P1|Participant Flow|13vPnC+TIV Followed by Placebo 1 Month Later|Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM), followed by a single 0.5 mL 13vPnC placebo vaccine, 1 month later.
1127966|NCT00492557|O2|Outcome|13vPnC|Single 0.5 mL 13vPnC (administered 1 month after single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, IM).
1127967|NCT00492557|O1|Outcome|13vPnC+TIV|Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM).
1127968|NCT00492557|O2|Outcome|13vPnC|Single 0.5 mL 13vPnC (administered 1 month after single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, IM).
1127969|NCT00492557|O1|Outcome|13vPnC+TIV|Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM).
1127970|NCT00492557|O2|Outcome|13vPnC|Single 0.5 mL 13vPnC (administered 1 month after single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, IM).
1127971|NCT00492557|O1|Outcome|13vPnC+TIV|Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM).
1127972|NCT00492557|O2|Outcome|13vPnC|Single 0.5 mL 13vPnC (administered 1 month after single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, IM).
1127973|NCT00492557|O1|Outcome|13vPnC+TIV|Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM).
1127974|NCT00492557|O2|Outcome|Placebo+TIV|Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM.
1127975|NCT00492557|O1|Outcome|13vPnC+TIV|Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM).
1127976|NCT00492557|E4|Reported Event|13vPnC|Single 0.5 mL 13vPnC (administered 1 month after single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, IM [Placebo + TIV]).
1127977|NCT00492557|E3|Reported Event|Placebo+TIV|Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM.
1127978|NCT00492557|E2|Reported Event|Placebo|Single 0.5 mL 13vPnC placebo vaccine (administered 1 month after a single 0.5 mL 13vPnC and a single 0.5 mL TIV, IM [13vPnC + TIV]).
1127979|NCT00492557|E1|Reported Event|13vPnC+TIV|Single 0.5 mL 13vPnC and a single 0.5 mL TIV, administered IM.
1127980|NCT00492544|B1|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
1127981|NCT00492544|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
1127982|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
1127983|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
1127984|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
1127985|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
1127986|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
1127987|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
1127988|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
1127989|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
1127990|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
1127991|NCT00492544|E1|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
1127992|NCT00492531|B3|Baseline|Total|Total of all reporting groups
1127993|NCT00492531|B2|Baseline|Placebo|Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
1127994|NCT00492531|B1|Baseline|Sildenafil|Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
1128103|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
1127995|NCT00492531|P2|Participant Flow|Placebo|Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
1127996|NCT00492531|P1|Participant Flow|Sildenafil|Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
1127997|NCT00492531|O2|Outcome|Placebo|Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
1127998|NCT00492531|O1|Outcome|Sildenafil|Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
1127999|NCT00492531|O2|Outcome|Placebo|Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
1128000|NCT00492531|O1|Outcome|Sildenafil|Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
1128001|NCT00492531|O2|Outcome|Placebo|Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
1128002|NCT00492531|O1|Outcome|Sildenafil|Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
1128003|NCT00492531|O2|Outcome|Placebo|Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
1128004|NCT00492531|O1|Outcome|Sildenafil|Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
1128005|NCT00492531|E2|Reported Event|Placebo|Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
1128006|NCT00492531|E1|Reported Event|Sildenafil|Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
1128007|NCT00492401|B1|Baseline|Decitabine|Decitabine 20mg/m2/day IV over 1 hour, days 1-10, repeat cycle every 28 days
1128008|NCT00492401|P1|Participant Flow|Decitabine|Decitabine 20mg/m2/day IV over 1 hour, days 1-10, repeat cycle every 28 days
1128009|NCT00492401|O1|Outcome|Decitabine|Decitabine 20mg/m2/day IV over 1 hour, days 1-10, repeat cycle every 28 days
1128010|NCT00492401|O1|Outcome|Decitabine|Decitabine 20mg/m2/day IV over 1 hour, days 1-10, repeat cycle every 28 days
1128011|NCT00492401|O2|Outcome|Non Responder|Any patient that did not achieve a CR (Complete Response), or Incomplete CR was categorized as a non responder.
1128012|NCT00492401|O1|Outcome|Responders|Any patient that achieved a CR (Complete Response), or Incomplete CR was categorized as a responder.
1128013|NCT00492401|O1|Outcome|Decitabine|Decitabine 20mg/m2/day IV over 1 hour, days 1-10, repeat cycle every 28 days
1128014|NCT00492401|O1|Outcome|Decitabine|Decitabine 20mg/m2/day IV over 1 hour, days 1-10, repeat cycle every 28 days
1128015|NCT00492401|E1|Reported Event|Treatment (Chemotherapy)|"Patients receive decitabine IV over 1 hour on days 1-10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~decitabine: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~high performance liquid chromatography: Correlative studies~microarray analysis: Correlative studies~RNA analysis: Correlative studies~mass spectrometry: Correlative studies~DNA methylation analysis: Correlative studies~matrix-assisted laser desorption/ionization time of flight mass spectrometry: Correlative studies"
1128016|NCT00492336|B3|Baseline|Total|Total of all reporting groups
1128017|NCT00492336|B2|Baseline|Inactive Pill|Treatment with Placebo
1128018|NCT00492336|B1|Baseline|Rasagiline|Treatment with Rasagiline
1128019|NCT00492336|P2|Participant Flow|Inactive Pill|Treatment with Placebo
1128020|NCT00492336|P1|Participant Flow|Rasagiline|Treatment with Rasagiline
1128021|NCT00492336|O2|Outcome|Inactive Pill|Treatment with Placebo
1128022|NCT00492336|O1|Outcome|Rasagiline|Treatment with Rasagiline
1128023|NCT00492336|E2|Reported Event|Inactive Pill|Treatment with Placebo
1128024|NCT00492336|E1|Reported Event|Rasagiline|Treatment with Rasagiline
1128025|NCT00492297|B1|Baseline|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
1128056|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
1128057|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
1128096|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
1128026|NCT00492297|P1|Participant Flow|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid), the treatment continued until subjects had clear palliative benefit and were tolerating treatment well, or until progressive disease (PD) or death (if earlier) recorded up to 97 weeks. Subjects withdrawn from Sorafenib but with optional standard treatment entered Active Follow-up (AFU) period, which was 30(+4) days for subjects who had PD at the end of treatment; or until PD was documented for subjects who had complete response (CR) or partial response (PR) or stable disease (SD) at the end of treatment up to 97 weeks . Once subject progressed went into survival only follow-up which continued until death occurred up to 172 weeks.
1128027|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
1128028|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
1128029|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
1128030|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
1128031|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
1128032|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
1128033|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
1128034|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
1128035|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
1128036|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
1128037|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
1128038|NCT00492297|E1|Reported Event|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
1128039|NCT00492284|B5|Baseline|Total|Total of all reporting groups
1128040|NCT00492284|B4|Baseline|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
1128041|NCT00492284|B3|Baseline|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
1128042|NCT00492284|B2|Baseline|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
1128043|NCT00492284|B1|Baseline|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
1128044|NCT00492284|P4|Participant Flow|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
1128045|NCT00492284|P3|Participant Flow|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
1128046|NCT00492284|P2|Participant Flow|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
1128047|NCT00492284|P1|Participant Flow|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
1128048|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
1128049|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
1128050|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
1128051|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
1128052|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
1128053|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
1128054|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
1128055|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
1128058|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
1128059|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
1128060|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
1128061|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
1128104|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
1128062|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
1128063|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
1128064|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
1128065|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
1128066|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
1128067|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
1128068|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
1128069|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
1128070|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
1128071|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
1128072|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
1128073|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
1128074|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
1128075|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
1128076|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
1128077|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
1128078|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
1128079|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
1128080|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
1128081|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
1128082|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
1128083|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
1128084|NCT00492284|E4|Reported Event|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
1128085|NCT00492284|E3|Reported Event|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
1128086|NCT00492284|E2|Reported Event|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
1128087|NCT00492284|E1|Reported Event|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
1128088|NCT00492232|B3|Baseline|Total|Total of all reporting groups
1128089|NCT00492232|B2|Baseline|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
1128090|NCT00492232|B1|Baseline|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
1128097|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
1128098|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
1128099|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
1128100|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
1128101|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
1128102|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
1128105|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
1128106|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
1128107|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
1128108|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
1128109|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
1128110|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
1128111|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
1128112|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
1128113|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
1128114|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
1128115|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
1128116|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
1128117|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
1128118|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
1128119|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
1128120|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
1128121|NCT00492232|E2|Reported Event|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
1128122|NCT00492232|E1|Reported Event|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
1128123|NCT00492206|B1|Baseline|Chest Radiotherapy + Cetuximab + Consolidation Therapy With ca|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
1128124|NCT00492206|P1|Participant Flow|Chest Radiotherapy + Cetuximab + Consolidation Therapy With ca|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
1128125|NCT00492206|O1|Outcome|Chest Radiotherapy + Cetuximab + Consolidation Therapy With ca|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
1128126|NCT00492206|O1|Outcome|Received Concurrent Radiotherapy + Cetuximab|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
1128127|NCT00492206|O1|Outcome|Received ≥1 Dose of Cetuximab|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
1128128|NCT00492206|O1|Outcome|Received ≥1 Dose of Cetuximab|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
1128129|NCT00492206|E1|Reported Event|Chest Radiotherapy + Cetuximab + Consolidation Therapy With ca|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
1128130|NCT00492089|B3|Baseline|Total|Total of all reporting groups
1128131|NCT00492089|B2|Baseline|Crossover Arm B: Placebo First, Then Bevacizumab|Placebo IV every 3 weeks for two courses, crossover at 6 weeks to receive Bevacizumab 7.5 mg/m^2 IV as in Arm A
1128133|NCT00492089|P2|Participant Flow|Crossover Arm B: Placebo First, Then Bevacizumab|Placebo IV every 3 weeks for two courses, crossover at 6 weeks to receive Bevacizumab 7.5 mg/m^2 IV as in Arm A.
1128134|NCT00492089|P1|Participant Flow|Arm A: Bevacizumab|Bevacizumab 7.5 mg/m^2 intravenous (IV) every 3 weeks.
1128135|NCT00492089|O2|Outcome|Crossover Arm B: Placebo Then Bevacizumab|Placebo IV every 3 weeks for two courses, crossover at 6 weeks to receive Bevacizumab 7.5 mg/m^2 IV as in Arm A
1128136|NCT00492089|O1|Outcome|Arm A: Bevacizumab|Bevacizumab 7.5 mg/m^2 intravenous (IV) every 3 weeks
1128137|NCT00492089|E2|Reported Event|Placebo|First Intervention Placebo IV (only) every 3 weeks for two courses
1128138|NCT00492089|E1|Reported Event|Bevacizumab|Bevacizumab 7.5 mg/m^2 intravenous (IV) every 3 weeks
1128139|NCT00492063|B5|Baseline|Total|Total of all reporting groups
1128140|NCT00492063|B4|Baseline|TIV (Elderly)|Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
1128141|NCT00492063|B3|Baseline|cTIV (Elderly)|Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
1128142|NCT00492063|B2|Baseline|TIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
1128143|NCT00492063|B1|Baseline|cTIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
1128144|NCT00492063|P4|Participant Flow|TIV (Elderly)|Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
1128145|NCT00492063|P3|Participant Flow|cTIV (Elderly)|Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
1128146|NCT00492063|P2|Participant Flow|TIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
1128147|NCT00492063|P1|Participant Flow|cTIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
1128148|NCT00492063|O4|Outcome|TIV (Elderly)|Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
1128149|NCT00492063|O3|Outcome|cTIV (Elderly)|Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
1128150|NCT00492063|O2|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
1128151|NCT00492063|O1|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
1128152|NCT00492063|O4|Outcome|TIV (Elderly)|Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
1128153|NCT00492063|O3|Outcome|cTIV (Elderly)|Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
1128154|NCT00492063|O2|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
1128155|NCT00492063|O1|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
1128156|NCT00492063|O4|Outcome|TIV (Elderly)|Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
1128157|NCT00492063|O3|Outcome|cTIV (Elderly)|Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
1128158|NCT00492063|O2|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
1128159|NCT00492063|O1|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
1128160|NCT00492063|O4|Outcome|TIV (Elderly)|Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
1128161|NCT00492063|O3|Outcome|cTIV (Elderly)|Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
1128162|NCT00492063|O2|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
1128163|NCT00492063|O1|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
1128164|NCT00492063|E4|Reported Event|TIV (Elderly)|Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
1128165|NCT00492063|E3|Reported Event|cTIV (Elderly)|Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
1128166|NCT00492063|E2|Reported Event|TIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
1128167|NCT00492063|E1|Reported Event|cTIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
1128168|NCT00492024|B3|Baseline|Total|Total of all reporting groups
1128169|NCT00492024|B2|Baseline|Placebo|Matching placebo for 5 days
1128170|NCT00492024|B1|Baseline|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
1128171|NCT00492024|P2|Participant Flow|Placebo|Matching placebo for 5 days
1128172|NCT00492024|P1|Participant Flow|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
1128173|NCT00492024|O2|Outcome|Placebo|Matching placebo for 5 days
1128174|NCT00492024|O1|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
1128175|NCT00492024|O2|Outcome|Placebo|Matching placebo for 5 days
1128176|NCT00492024|O1|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
1128177|NCT00492024|O2|Outcome|Placebo|Matching placebo for 5 days
1128178|NCT00492024|O1|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
1128179|NCT00492024|O2|Outcome|Placebo|Matching placebo for 5 days
1128180|NCT00492024|O1|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
1128181|NCT00492024|O2|Outcome|Placebo|Matching placebo for 5 days
1128182|NCT00492024|O1|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
1128183|NCT00492024|O2|Outcome|Placebo|Matching placebo for 5 days
1128184|NCT00492024|O1|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
1128187|NCT00491894|B1|Baseline|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
1128188|NCT00491894|P1|Participant Flow|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
1128189|NCT00491894|O1|Outcome|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
1128190|NCT00491894|O1|Outcome|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
1128790|NCT00490035|B4|Baseline|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
1128191|NCT00491894|O1|Outcome|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
1128192|NCT00491894|O1|Outcome|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
1128193|NCT00491894|O1|Outcome|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
1128194|NCT00491894|E1|Reported Event|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
1128195|NCT00491829|B4|Baseline|Total|Total of all reporting groups
1128196|NCT00491829|B3|Baseline|Placebo|"placebo qhs~placebo: placebo"
1128197|NCT00491829|B2|Baseline|Flibanserin 100mg|"100 mg qhs~BIMT 17 BS 100 mg: flibanserin 100mg"
1128198|NCT00491829|B1|Baseline|Flibanserin 50mg|"50 mg qhs~BIMT 17 BS 50 mg: flibanserin 50 mg"
1128199|NCT00491829|P3|Participant Flow|Placebo|"placebo qhs~placebo: placebo"
1128200|NCT00491829|P2|Participant Flow|Flibanserin 100mg|"100 mg qhs~BIMT 17 BS 100 mg: flibanserin 100mg"
1128201|NCT00491829|P1|Participant Flow|Flibanserin 50mg|"50 mg qhs~BIMT 17 BS 50 mg: flibanserin 50 mg"
1128202|NCT00491829|O3|Outcome|Placebo|"placebo qhs~placebo: placebo"
1128203|NCT00491829|O2|Outcome|Flibanserin 100mg|"100 mg qhs~BIMT 17 BS 100 mg: flibanserin 100mg"
1128204|NCT00491829|O1|Outcome|Flibanserin 50mg|"50 mg qhs~BIMT 17 BS 50 mg: flibanserin 50 mg"
1128205|NCT00491829|E3|Reported Event|Placebo|"placebo qhs~placebo: placebo"
1128206|NCT00491829|E2|Reported Event|Flibanserin 100mg|"100 mg qhs~BIMT 17 BS 100 mg: flibanserin 100mg"
1128207|NCT00491829|E1|Reported Event|Flibanserin 50mg|"50 mg qhs~BIMT 17 BS 50 mg: flibanserin 50 mg"
1128208|NCT00491764|B7|Baseline|Total|Total of all reporting groups
1128209|NCT00491764|B6|Baseline|Placebo for 24 Weeks|Placebo for 24 weeks.
1128210|NCT00491764|B5|Baseline|Terbinafine 250 mg QD for 12 Weeks.|Terbinafine 250 mg QD for 12 weeks.
1128211|NCT00491764|B4|Baseline|Posaconazole 400 mg QD for 12 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
1128212|NCT00491764|B3|Baseline|Posaconazole 400 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
1128213|NCT00491764|B2|Baseline|Posaconazole 200 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
1128214|NCT00491764|B1|Baseline|Posaconazole 100 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
1128215|NCT00491764|P6|Participant Flow|Placebo for 24 Weeks|Placebo for 24 weeks.
1128216|NCT00491764|P5|Participant Flow|Terbinafine 250 mg QD for 12 Weeks.|Terbinafine 250 mg QD for 12 weeks.
1128217|NCT00491764|P4|Participant Flow|Posaconazole 400 mg QD for 12 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
1128218|NCT00491764|P3|Participant Flow|Posaconazole 400 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
1128219|NCT00491764|P2|Participant Flow|Posaconazole 200 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
1128220|NCT00491764|P1|Participant Flow|Posaconazole 100 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
1128221|NCT00491764|O6|Outcome|Placebo for 24 Weeks|Placebo for 24 weeks.
1128222|NCT00491764|O5|Outcome|Terbinafine 250 mg QD for 12 Weeks.|Terbinafine 250 mg QD for 12 weeks.
1128223|NCT00491764|O4|Outcome|Posaconazole 400 mg QD for 12 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
1128224|NCT00491764|O3|Outcome|Posaconazole 400 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
1128225|NCT00491764|O2|Outcome|Posaconazole 200 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
1128226|NCT00491764|O1|Outcome|Posaconazole 100 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
1128227|NCT00491764|O6|Outcome|Placebo for 24 Weeks|Placebo for 24 weeks.
1128228|NCT00491764|O5|Outcome|Terbinafine 250 mg QD for 12 Weeks.|Terbinafine 250 mg QD for 12 weeks.
1128229|NCT00491764|O4|Outcome|Posaconazole 400 mg QD for 12 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
1128230|NCT00491764|O3|Outcome|Posaconazole 400 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
1128231|NCT00491764|O2|Outcome|Posaconazole 200 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
1128232|NCT00491764|O1|Outcome|Posaconazole 100 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
1128233|NCT00491764|O6|Outcome|Placebo for 24 Weeks|Placebo for 24 weeks.
1128234|NCT00491764|O5|Outcome|Terbinafine 250 mg QD for 12 Weeks.|Terbinafine 250 mg QD for 12 weeks.
1128235|NCT00491764|O4|Outcome|Posaconazole 400 mg QD for 12 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
1128236|NCT00491764|O3|Outcome|Posaconazole 400 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
1128237|NCT00491764|O2|Outcome|Posaconazole 200 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
1128238|NCT00491764|O1|Outcome|Posaconazole 100 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
1128239|NCT00491764|E6|Reported Event|Placebo for 24 Weeks|Placebo for 24 weeks
1128240|NCT00491764|E5|Reported Event|Terbinafine 250 mg QD for 12 Weeks|Terbinafine 250 mg QD for 12 weeks
1128241|NCT00491764|E4|Reported Event|Posaconazole 400 mg QD for 12 Weeks|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks
1128242|NCT00491764|E3|Reported Event|Posaconazole 400 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks
1128243|NCT00491764|E2|Reported Event|Posaconazole 200 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks
1128244|NCT00491764|E1|Reported Event|Posaconazole 100 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 100 mg QD for 24 weeks
1128245|NCT00491738|B3|Baseline|Total|Total of all reporting groups
1128246|NCT00491738|B2|Baseline|Placebo + Sunitinib|Intravenous infusion of placebo every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
1128247|NCT00491738|B1|Baseline|Bevacizumab + Sunitinib|Intravenous infusion of bevacizumab every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
1128248|NCT00491738|P2|Participant Flow|Placebo + Sunitinib|Intravenous infusion of placebo every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
1128249|NCT00491738|P1|Participant Flow|Bevacizumab + Sunitinib|Intravenous infusion of bevacizumab every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
1128250|NCT00491738|O2|Outcome|Placebo + Sunitinib|Intravenous infusion of placebo every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
1128251|NCT00491738|O1|Outcome|Bevacizumab + Sunitinib|Intravenous infusion of bevacizumab every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
1128252|NCT00491608|B1|Baseline|rThrombin|Participants who received at least 1 application of rThrombin during spinal or vascular surgery (arterial reconstruction or PAB,or AV vascular access procedure and had seronegative baseline rThrombin antibody status
1128253|NCT00491608|P1|Participant Flow|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
1128254|NCT00491608|O1|Outcome|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
1128255|NCT00491608|O1|Outcome|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
1128256|NCT00491608|O1|Outcome|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
1128257|NCT00491608|O1|Outcome|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
1128258|NCT00491608|O1|Outcome|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
1128259|NCT00491608|O1|Outcome|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
1128260|NCT00491608|E1|Reported Event|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
1128261|NCT00491556|B3|Baseline|Total|Total of all reporting groups
1128262|NCT00491556|B2|Baseline|Standard Care Arm|"Subjects randomized to the standard care arm will begin HAART with TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS standard of care and will be followed for a total of three years. Under these guidelines and under current clinical standards, subjects on the standard care arm will begin therapy when the CD4+ T cell count drops below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician occur.~Standard Care: Progression: Subjects on the standard care arm will begin therapy when the CD4+ T cell count drops below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician occur. Treatment: HAART with TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS standard of care. Duration: three years."
1128263|NCT00491556|B1|Baseline|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128264|NCT00491556|P2|Participant Flow|Standard Care (STAND)|Began HAART with ATV/r under the current DHHS guidelines (CD4+ T cells below 350 cells/mm3 or for other clinical concerns as outlined in the recommendations and as determined by the site clinician).
1128503|NCT00490945|E4|Reported Event|50 mg VEC-162|Randomized to 50 mg VEC-162
1128265|NCT00491556|P1|Participant Flow|Experimental-Early Initiation of HAART (EXP)|Began HAART consisting of TDF/FTC/ATV/r (preferred regimen), AZT/3TC/ATV/r, or other recommended NRTI HAART backbone with ATV/r upon entry to study. Subjects who achieved virologic control by week 24 (viral load (VL) < 100 copies/ml) and maintained good control through 48 weeks then entered deintensification (de-int) to ATV/r alone and were followed for two years.
1128340|NCT00491530|O2|Outcome|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
1128341|NCT00491530|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
1128266|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128267|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128268|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128269|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128270|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128271|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128272|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128273|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128335|NCT00491530|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
1128391|NCT00491244|B2|Baseline|Peginterferon|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
1138840|NCT00464438|O1|Outcome|Gatifloxacin 0.3%|
1128342|NCT00491530|O3|Outcome|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
1131370|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
1128274|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128275|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128276|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128277|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128278|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128279|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128280|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128281|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128282|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128429|NCT00490971|O5|Outcome|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
1128283|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128284|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128285|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128286|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128287|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128288|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128289|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128290|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128291|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128483|NCT00490945|O4|Outcome|100 mg VEC-162|Randomized to 100 mg VEC-162
1128484|NCT00490945|O3|Outcome|50 mg VEC-162|Randomized to 50 mg VEC-162
1128292|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128293|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128294|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128295|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128296|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128297|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128298|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128299|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128336|NCT00491530|O3|Outcome|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
1128337|NCT00491530|O2|Outcome|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
1128485|NCT00490945|O2|Outcome|20 mg VEC-162|Randomized to 20 mg VEC-162
1128300|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128301|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128302|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128303|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128304|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128305|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128306|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128307|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128338|NCT00491530|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
1128339|NCT00491530|O3|Outcome|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
1128486|NCT00490945|O1|Outcome|10 mg VEC-162|Randomized to 10 mg VEC-162
1128308|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128309|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128310|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128311|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128312|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128313|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128314|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128315|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128316|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128383|NCT00491374|B1|Baseline|Placebo|
1128317|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128318|NCT00491556|E2|Reported Event|Standard Care Arm|"Subjects randomized to the standard care arm will begin HAART with TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS standard of care and will be followed for a total of three years. Under these guidelines and under current clinical standards, subjects on the standard care arm will begin therapy when the CD4+ T cell count drops below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician occur.~Standard Care: Progression: Subjects on the standard care arm will begin therapy when the CD4+ T cell count drops below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician occur. Treatment: HAART with TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS standard of care. Duration: three years."
1128319|NCT00491556|E1|Reported Event|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
1128320|NCT00491530|B4|Baseline|Total|Total of all reporting groups
1128321|NCT00491530|B3|Baseline|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
1128322|NCT00491530|B2|Baseline|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
1128323|NCT00491530|B1|Baseline|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
1128324|NCT00491530|P3|Participant Flow|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
1128325|NCT00491530|P2|Participant Flow|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
1128326|NCT00491530|P1|Participant Flow|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
1128327|NCT00491530|O3|Outcome|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
1128328|NCT00491530|O2|Outcome|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
1128329|NCT00491530|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
1128330|NCT00491530|O3|Outcome|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
1128331|NCT00491530|O2|Outcome|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
1128332|NCT00491530|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
1128333|NCT00491530|O3|Outcome|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
1128334|NCT00491530|O2|Outcome|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
1128384|NCT00491374|P2|Participant Flow|Mometasone Furoate Nasal Spray|
1128385|NCT00491374|P1|Participant Flow|Placebo|
1128343|NCT00491530|O2|Outcome|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
1128344|NCT00491530|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
1128345|NCT00491530|O3|Outcome|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
1128346|NCT00491530|O2|Outcome|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
1128347|NCT00491530|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
1128348|NCT00491530|E3|Reported Event|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
1128349|NCT00491530|E2|Reported Event|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
1128350|NCT00491530|E1|Reported Event|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
1128351|NCT00491504|B5|Baseline|Total|Total of all reporting groups
1128352|NCT00491504|B4|Baseline|Placebo Day 8|Placebo: 2 sprays each nostril for 7 days
1128353|NCT00491504|B3|Baseline|Mometasone Furoate Nasal Spray Day 8|Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (200 mcg daily) for 7 days
1128354|NCT00491504|B2|Baseline|Placebo Day 1|Placebo: 2 sprays each nostril for 1 dose
1128355|NCT00491504|B1|Baseline|Mometasone Furoate Nasal Spray Day 1|Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (total 200 mcg) for 1 dose
1128356|NCT00491504|P4|Participant Flow|Placebo Day 8|Placebo: 2 sprays each nostril for 7 days
1128357|NCT00491504|P3|Participant Flow|Mometasone Furoate Nasal Spray Day 8|Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (200 mcg daily) for 7 days
1128358|NCT00491504|P2|Participant Flow|Placebo Day 1|Placebo: 2 sprays each nostril for 1 dose
1128359|NCT00491504|P1|Participant Flow|Mometasone Furoate Nasal Spray Day 1|Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (total 200 mcg) for 1 dose
1128360|NCT00491504|O2|Outcome|Placebo|All subjects who received 2 sprays each nostril of placebo on Day 1
1128361|NCT00491504|O1|Outcome|Mometasone Furoate Nasal Spray 200 mcg|All subjects who received 2 sprays each nostril (total 200 mcg) of Mometasone Furoate Nasal Spray (MFNS) on Day 1
1128362|NCT00491504|E4|Reported Event|Placebo Day 8|Placebo: 2 sprays each nostril for 7 days
1128363|NCT00491504|E3|Reported Event|Mometasone Furoate Nasal Spray Day 8|Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (200 mcg daily) for 7 days
1128364|NCT00491504|E2|Reported Event|Placebo Day 1|Placebo: 2 sprays each nostril for 1 dose
1128365|NCT00491504|E1|Reported Event|Mometasone Furoate Nasal Spray Day 1|Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (total 200 mcg) for 1 dose
1128366|NCT00491400|B3|Baseline|Total|Total of all reporting groups
1128367|NCT00491400|B2|Baseline|Atorvastatin First|Atorvastatin First and Fenofibrate Second
1128368|NCT00491400|B1|Baseline|Fenofibrate First|Fenofibrate First and Atorvastatin Second
1128369|NCT00491400|P2|Participant Flow|Atorvastatin First|Participants randomized to receive atorvastatin first and fenofibrate second
1128370|NCT00491400|P1|Participant Flow|Fenofibrate First|Participants randomized to receive fenofibrate first and atorvastatin second
1128371|NCT00491400|O2|Outcome|Atorvastatin|Effect of atorvastatin treatment on lipid profile
1128372|NCT00491400|O1|Outcome|Fenofibrate|Effect of fenofibrate treatment on lipid profile
1128373|NCT00491400|O2|Outcome|Atorvastatin Treatment|Effect of atorvastatin on brachial artery FMD
1128374|NCT00491400|O1|Outcome|Fenofibrate Treatment|Effect of fenofibrate on brachial artery FMD
1128375|NCT00491400|E2|Reported Event|Atorvastatin First|Atorvastatin First and Fenofibrate Second
1128376|NCT00491400|E1|Reported Event|Fenofibrate First|Fenofibrate First and Atorvastatin Second
1128377|NCT00491387|B1|Baseline|Group 1|
1128378|NCT00491387|P1|Participant Flow|Group 1|
1128379|NCT00491387|O1|Outcome|Group 1|
1128380|NCT00491387|E1|Reported Event|Group 1|
1128381|NCT00491374|B3|Baseline|Total|Total of all reporting groups
1128382|NCT00491374|B2|Baseline|Mometasone Furoate Nasal Spray|
1128392|NCT00491244|B1|Baseline|Peginterferon and Ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
1128393|NCT00491244|P2|Participant Flow|Peginterferon|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
1128394|NCT00491244|P1|Participant Flow|Peginterferon and Ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
1128395|NCT00491244|O2|Outcome|Peginterferon|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
1131371|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
1128396|NCT00491244|O1|Outcome|Peginterferon and Ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
1128397|NCT00491244|O2|Outcome|Peginterferon|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
1128398|NCT00491244|O1|Outcome|Peginterferon and Ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
1128399|NCT00491244|E2|Reported Event|Peginterferon|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
1128400|NCT00491244|E1|Reported Event|Peginterferon and Ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
1128401|NCT00491179|B3|Baseline|Total|Total of all reporting groups
1128402|NCT00491179|B2|Baseline|Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
1128403|NCT00491179|B1|Baseline|Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks
1128404|NCT00491179|P2|Participant Flow|Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
1128405|NCT00491179|P1|Participant Flow|Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks
1128406|NCT00491179|O2|Outcome|Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
1128407|NCT00491179|O1|Outcome|Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks
1128408|NCT00491179|O2|Outcome|Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
1128409|NCT00491179|O1|Outcome|Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks
1128410|NCT00491179|E2|Reported Event|Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
1128411|NCT00491179|E1|Reported Event|Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks
1128412|NCT00491075|B1|Baseline|Pemetrexed + Gemcitabine|Pemetrexed 500 mg/m^2 intravenous (IV) and Gemcitabine 1500 mg/m^2 IV on Day 1.
1128413|NCT00491075|P1|Participant Flow|Pemetrexed + Gemcitabine|Pemetrexed 500 mg/m^2 intravenous (IV) and Gemcitabine 1500 mg/m^2 IV on Day 1.
1128414|NCT00491075|O1|Outcome|Pemetrexed + Gemcitabine|Pemetrexed 500 mg/m^2 intravenous (IV) and Gemcitabine 1500 mg/m^2 IV on Day 1.
1128415|NCT00491075|E1|Reported Event|Pemetrexed + Gemcitabine|Pemetrexed 500 mg/m^2 intravenous (IV) and Gemcitabine 1500 mg/m^2 IV on Day 1.
1128416|NCT00490971|B3|Baseline|Total|Total of all reporting groups
1128417|NCT00490971|B2|Baseline|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
1128418|NCT00490971|B1|Baseline|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
1128419|NCT00490971|P5|Participant Flow|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
1128420|NCT00490971|P4|Participant Flow|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
1128421|NCT00490971|P3|Participant Flow|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
1128422|NCT00490971|P2|Participant Flow|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
1128423|NCT00490971|P1|Participant Flow|Paliperidone Extented Release (ER)|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
1128424|NCT00490971|O5|Outcome|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
1128425|NCT00490971|O4|Outcome|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
1128426|NCT00490971|O3|Outcome|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
1128427|NCT00490971|O2|Outcome|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
1128428|NCT00490971|O1|Outcome|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
1128487|NCT00490945|O5|Outcome|100 mg VEC-162|Randomized to 100 mg VEC-162
1128430|NCT00490971|O4|Outcome|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
1128431|NCT00490971|O3|Outcome|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
1128432|NCT00490971|O2|Outcome|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
1128433|NCT00490971|O1|Outcome|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
1128434|NCT00490971|O5|Outcome|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
1131372|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
1128435|NCT00490971|O4|Outcome|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
1128436|NCT00490971|O3|Outcome|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
1128437|NCT00490971|O2|Outcome|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
1128438|NCT00490971|O1|Outcome|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
1128439|NCT00490971|O5|Outcome|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
1128440|NCT00490971|O4|Outcome|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
1128441|NCT00490971|O3|Outcome|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
1128442|NCT00490971|O2|Outcome|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
1128443|NCT00490971|O1|Outcome|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
1128444|NCT00490971|O5|Outcome|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
1128445|NCT00490971|O4|Outcome|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
1128446|NCT00490971|O3|Outcome|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
1128447|NCT00490971|O2|Outcome|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
1128448|NCT00490971|O1|Outcome|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
1128449|NCT00490971|O5|Outcome|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
1128450|NCT00490971|O4|Outcome|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
1128451|NCT00490971|O3|Outcome|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
1128452|NCT00490971|O2|Outcome|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
1128453|NCT00490971|O1|Outcome|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
1128454|NCT00490971|O5|Outcome|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
1128455|NCT00490971|O4|Outcome|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
1128456|NCT00490971|O3|Outcome|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
1128457|NCT00490971|O2|Outcome|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
1128458|NCT00490971|O1|Outcome|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
1128459|NCT00490971|E5|Reported Event|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
1128460|NCT00490971|E4|Reported Event|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
1128461|NCT00490971|E3|Reported Event|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
1128462|NCT00490971|E2|Reported Event|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
1128463|NCT00490971|E1|Reported Event|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
1128464|NCT00490945|B6|Baseline|Total|Total of all reporting groups
1128465|NCT00490945|B5|Baseline|100 mg VEC-162|Randomized to 100 mg VEC-162
1128466|NCT00490945|B4|Baseline|50 mg VEC-162|Randomized to 50 mg VEC-162
1128467|NCT00490945|B3|Baseline|20 mg VEC-162|Randomized to 20 mg VEC-162
1128468|NCT00490945|B2|Baseline|10 mg VEC-162|Randomized to 10 mg VEC-162
1128469|NCT00490945|B1|Baseline|Placebo|Randomized to Placebo
1128470|NCT00490945|P5|Participant Flow|100 mg VEC-162|Randomized to 100 mg VEC-162
1128471|NCT00490945|P4|Participant Flow|50 mg VEC-162|Randomized to 50 mg VEC-162
1128472|NCT00490945|P3|Participant Flow|20 mg VEC-162|Randomized to 20 mg VEC-162
1128473|NCT00490945|P2|Participant Flow|10 mg VEC-162|Randomized to 10 mg VEC-162
1128474|NCT00490945|P1|Participant Flow|Placebo|Randomized to Placebo
1128475|NCT00490945|O4|Outcome|100 mg VEC-162|Randomized to 100 mg VEC-162
1128476|NCT00490945|O3|Outcome|50 mg VEC-162|Randomized to 50 mg VEC-162
1128477|NCT00490945|O2|Outcome|20 mg VEC-162|Randomized to 20 mg VEC-162
1128478|NCT00490945|O1|Outcome|10 mg VEC-162|Randomized to 10 mg VEC-162
1128479|NCT00490945|O4|Outcome|100 mg VEC-162|Randomized to 100 mg VEC-162
1128480|NCT00490945|O3|Outcome|50 mg VEC-162|Randomized to 50 mg VEC-162
1128481|NCT00490945|O2|Outcome|20 mg VEC-162|Randomized to 20 mg VEC-162
1128482|NCT00490945|O1|Outcome|10 mg VEC-162|Randomized to 10 mg VEC-162
1128504|NCT00490945|E3|Reported Event|20 mg VEC-162|Randomized to 20 mg VEC-162
1128505|NCT00490945|E2|Reported Event|10 mg VEC-162|Randomized to 10 mg VEC-162
1128506|NCT00490945|E1|Reported Event|Placebo|Randomized to Placebo
1128507|NCT00490919|B3|Baseline|Total|Total of all reporting groups
1128508|NCT00490919|B2|Baseline|Double-blind Placebo TDS|Matching placebo TDS 10 or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
1128509|NCT00490919|B1|Baseline|Double-blind BTDS|Buprenorphine transdermal patch 10 mcg/h or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
1128510|NCT00490919|P3|Participant Flow|Double-blind Placebo TDS|Matching placebo transdermal patch (placebo TDS) 10 or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase.
1128511|NCT00490919|P2|Participant Flow|Double-blind BTDS 10 or 20|Buprenorphine transdermal patch (BTDS) 10 mcg/h or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase.
1128512|NCT00490919|P1|Participant Flow|Open-label Run-in Period|"The open-label run-in period (< 27 days) (N = 1024 started) was designed to select subjects for randomization who met both tolerability and responsiveness criteria for either BTDS 10 or 20 (an enriched design).~Upon completion of the run-in period, 541 subjects were randomized and received treatment in the double-blind phase. Two subjects had no safety data after the randomization visit; therefore N = 539 for the randomized safety population."
1128513|NCT00490919|O2|Outcome|Double-blind Placebo TDS|Matching placebo TDS 10 or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
1128514|NCT00490919|O1|Outcome|Double-blind BTDS|Buprenorphine transdermal patch 10 mcg/h or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
1128515|NCT00490919|O2|Outcome|Double-blind Placebo TDS|Matching placebo TDS 10 or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
1128516|NCT00490919|O1|Outcome|Double-blind BTDS|Buprenorphine transdermal patch 10 mcg/h or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
1128517|NCT00490919|O2|Outcome|Double-blind Placebo TDS|Matching placebo TDS 10 or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
1128518|NCT00490919|O1|Outcome|Double-blind BTDS|Buprenorphine transdermal patch 10 mcg/h or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
1128519|NCT00490919|E3|Reported Event|Open-label Run-in Period, BTDS 5, 10, 20|Open-label BTDS 5, 10, 20 applied for 7-day wear
1128520|NCT00490919|E2|Reported Event|Double-blind Placebo TDS 10, 20|Matching placebo TDS 10 or 20 applied for 7-day wear
1128521|NCT00490919|E1|Reported Event|Double-blind BTDS 10, 20|Buprenorphine transdermal patch 10 mcg/h or 20 mcg/h applied for 7-day wear
1128522|NCT00490841|B1|Baseline|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
1128523|NCT00490841|P1|Participant Flow|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
1128524|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
1128525|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
1128526|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
1128527|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
1128528|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
1128529|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
1128530|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
1128531|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
1128532|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
1128533|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
1128534|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
1138841|NCT00464438|E2|Reported Event|Moxifloxacin 0.5%|
1128535|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
1128536|NCT00490841|O1|Outcome|RX Herculink Elite|Subjects recieving the RX Herculink Elite
1128537|NCT00490841|O1|Outcome|RX Herculink Elite|Subjects recieving the RX Herculink Elite
1128538|NCT00490841|O1|Outcome|RX Herculink Elite|Subjects recieving the RX Herculink Elite
1128697|NCT00490555|E3|Reported Event|3) T Gel +Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
1131373|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
1128539|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
1128540|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
1128541|NCT00490841|E1|Reported Event|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
1128542|NCT00490815|B3|Baseline|Total|Total of all reporting groups
1128543|NCT00490815|B2|Baseline|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur Implant
1128544|NCT00490815|B1|Baseline|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
1128545|NCT00490815|P2|Participant Flow|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur Implant administered in one eye
1128546|NCT00490815|P1|Participant Flow|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant administered in one eye
1128547|NCT00490815|O2|Outcome|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur Implant
1128548|NCT00490815|O1|Outcome|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
1128549|NCT00490815|O2|Outcome|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur Implant
1128550|NCT00490815|O1|Outcome|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
1128551|NCT00490815|E2|Reported Event|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur Implant
1128552|NCT00490815|E1|Reported Event|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
1128553|NCT00490802|B3|Baseline|Total|Total of all reporting groups
1128554|NCT00490802|B2|Baseline|Placebo|"Drug~Placebo Comparator : Placebo Comparator"
1128555|NCT00490802|B1|Baseline|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
1128556|NCT00490802|P2|Participant Flow|Placebo|Placebo Comparator : Placebo Comparator
1128557|NCT00490802|P1|Participant Flow|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
1128558|NCT00490802|O2|Outcome|Placebo|"Drug~Placebo Comparator : Placebo Comparator"
1128559|NCT00490802|O1|Outcome|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
1128560|NCT00490802|O2|Outcome|Placebo|"Drug~Placebo Comparator : Placebo Comparator"
1128561|NCT00490802|O1|Outcome|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
1128562|NCT00490802|O2|Outcome|Placebo|"Drug~Placebo Comparator : Placebo Comparator"
1128563|NCT00490802|O1|Outcome|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
1128564|NCT00490802|O2|Outcome|Placebo|"Drug~Placebo Comparator : Placebo Comparator"
1128565|NCT00490802|O1|Outcome|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
1128566|NCT00490802|O2|Outcome|Placebo|Placebo Comparator : Placebo Comparator
1128567|NCT00490802|O1|Outcome|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
1128568|NCT00490802|E2|Reported Event|Placebo|"Drug~Placebo Comparator : Placebo Comparator"
1128569|NCT00490802|E1|Reported Event|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
1128570|NCT00490724|B4|Baseline|Total|Total of all reporting groups
1128571|NCT00490724|B3|Baseline|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
1128572|NCT00490724|B2|Baseline|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
1128573|NCT00490724|B1|Baseline|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
1128574|NCT00490724|P3|Participant Flow|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
1128575|NCT00490724|P2|Participant Flow|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
1128576|NCT00490724|P1|Participant Flow|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
1128981|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
1128577|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
1128698|NCT00490555|E2|Reported Event|2) Testosterone Gel|Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
1131374|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
1128578|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
1128579|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
1128580|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
1128581|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
1128582|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
1128583|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
1128584|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
1128585|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
1128586|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
1128587|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
1128588|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
1128589|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
1128590|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
1128591|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
1128592|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
1128593|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
1128594|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
1128595|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
1128596|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
1128597|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
1128598|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
1128599|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
1128600|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
1128601|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
1128602|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
1128603|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
1128604|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
1128605|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
1128606|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
1128607|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
1128608|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
1128609|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
1128610|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
1128611|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
1128612|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
1128613|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
1128614|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
1128615|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
1128616|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
1128617|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
1128618|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
1128619|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
1128620|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
1128621|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
1128622|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
1128623|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
1128624|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
1128625|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
1128626|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
1128627|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
1128628|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
1128629|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
1128630|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
1128631|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
1128632|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
1128633|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
1128634|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
1128635|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
1128636|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
1128637|NCT00490724|E3|Reported Event|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
1128638|NCT00490724|E2|Reported Event|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
1128639|NCT00490724|E1|Reported Event|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
1128640|NCT00490698|B1|Baseline|Zoledronate + Atorvastatin|Zoledronate 4 mg intravenous (IV) once every 4 Weeks + Atorvastatin 20 mg orally (PO) daily
1128641|NCT00490698|P1|Participant Flow|Zoledronate + Atorvastatin|Zoledronate 4 mg intravenous (IV) once every 4 Weeks + Atorvastatin 20 mg orally (PO) daily
1128642|NCT00490698|O1|Outcome|Zoledronate + Atorvastatin|Zoledronate 4 mg intravenous (IV) once every 4 Weeks + Atorvastatin 20 mg orally (PO) daily
1128643|NCT00490698|E1|Reported Event|Zoledronate + Atorvastatin|Zoledronate 4 mg intravenous (IV) once every 4 Weeks + Atorvastatin 20 mg orally (PO) daily
1128644|NCT00490646|B3|Baseline|Total|Total of all reporting groups
1128645|NCT00490646|B2|Baseline|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
1128646|NCT00490646|B1|Baseline|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
1128647|NCT00490646|P2|Participant Flow|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
1128648|NCT00490646|P1|Participant Flow|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
1128649|NCT00490646|O2|Outcome|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
1128650|NCT00490646|O1|Outcome|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
1128651|NCT00490646|O2|Outcome|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
1128652|NCT00490646|O1|Outcome|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
1128653|NCT00490646|O2|Outcome|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
1128654|NCT00490646|O1|Outcome|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
1131104|NCT00485433|B4|Baseline|SKY0402 High Dose|SKY0402 high dose given during hernia repair
1128655|NCT00490646|O2|Outcome|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
1128699|NCT00490555|E1|Reported Event|1) Placebo|Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
1128656|NCT00490646|O1|Outcome|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
1128657|NCT00490646|O2|Outcome|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
1128658|NCT00490646|O1|Outcome|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
1128659|NCT00490646|O2|Outcome|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
1128660|NCT00490646|O1|Outcome|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
1128661|NCT00490646|O2|Outcome|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
1128662|NCT00490646|O1|Outcome|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
1128663|NCT00490646|O2|Outcome|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
1128664|NCT00490646|O1|Outcome|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
1128665|NCT00490646|E2|Reported Event|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
1128666|NCT00490646|E1|Reported Event|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
1128667|NCT00490555|B5|Baseline|Total|Total of all reporting groups
1128668|NCT00490555|B4|Baseline|4) T Gel+ DMPA|Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
1128669|NCT00490555|B3|Baseline|3) T Gel +Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
1128670|NCT00490555|B2|Baseline|2) Testosterone Gel|Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
1128671|NCT00490555|B1|Baseline|1) Placebo|Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
1128672|NCT00490555|P4|Participant Flow|4) T Gel+DMPA|Testosterone 1% transdermal gel 10g, daily + placebo Dutasteride pill, daily + DMPA 300mg injection (IM)
1128673|NCT00490555|P3|Participant Flow|3) T Gel+Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
1128674|NCT00490555|P2|Participant Flow|2) Testosterone (T) Gel|Testosterone 1% transdermal gel 10g (Testim)+ placebo pill, daily + placebo DMPA
1128675|NCT00490555|P1|Participant Flow|1) Placebo|Placebo gel + Placebo pill + placebo DMPA
1128676|NCT00490555|O4|Outcome|4) T Gel+ DMPA|Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
1128677|NCT00490555|O3|Outcome|3) T Gel +Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
1128678|NCT00490555|O2|Outcome|2) Testosterone Gel|Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
1128679|NCT00490555|O1|Outcome|1) Placebo|Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
1128680|NCT00490555|O4|Outcome|4) T Gel+ DMPA|Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
1128681|NCT00490555|O3|Outcome|3) T Gel +Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
1128682|NCT00490555|O2|Outcome|2) Testosterone Gel|Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
1128683|NCT00490555|O1|Outcome|1) Placebo|Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
1128684|NCT00490555|O4|Outcome|4) T Gel+ DMPA|Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
1128685|NCT00490555|O3|Outcome|3) T Gel +Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
1128686|NCT00490555|O2|Outcome|2) Testosterone Gel|Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
1128687|NCT00490555|O1|Outcome|1) Placebo|Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
1128688|NCT00490555|O4|Outcome|4) T Gel+ DMPA|Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
1128689|NCT00490555|O3|Outcome|3) T Gel +Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
1128690|NCT00490555|O2|Outcome|2) Testosterone Gel|Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
1128691|NCT00490555|O1|Outcome|1) Placebo|Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
1128692|NCT00490555|O4|Outcome|4) T Gel+ DMPA|Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
1128693|NCT00490555|O3|Outcome|3) T Gel +Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
1128694|NCT00490555|O2|Outcome|2) Testosterone Gel|Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
1128695|NCT00490555|O1|Outcome|1) Placebo|Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
1138842|NCT00464438|E1|Reported Event|Gatifloxacin 0.3%|
1128696|NCT00490555|E4|Reported Event|4) T Gel+ DMPA|Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
1128700|NCT00490542|B3|Baseline|Total|Total of all reporting groups
1128701|NCT00490542|B2|Baseline|Geodon Arm|Participants in this arm received Geodon and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
1128702|NCT00490542|B1|Baseline|Placebo Arm|Participants in this arm received placebo and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
1128703|NCT00490542|P2|Participant Flow|Double-blind Flexible-dose Ziprasidone Arm|Participants in this arm received a flexible dose of ziprasidone and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon). Dosing for all subjects began at 20 mg twice a day and increased to between 80 and 160 mg/day total.
1128704|NCT00490542|P1|Participant Flow|Double-blind Flexible-dose Placebo Arm|Participants in this arm received placebo and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon). Dosing was flexible. Dosing for all subjects was determined based on clinician judgment in an identical manner to dosing in the ziprasidone arm.
1128705|NCT00490542|O2|Outcome|Placebo Arm|Participants in this arm received placebo and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
1128706|NCT00490542|O1|Outcome|Ziprasidone Arm|Participants in this arm received Geodon and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
1128707|NCT00490542|E2|Reported Event|Geodon Arm|Participants in this arm received Geodon and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
1128708|NCT00490542|E1|Reported Event|Placebo Arm|Participants in this arm received placebo and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
1128709|NCT00490490|B1|Baseline|Tositumomab + XRT + KI|Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
1128710|NCT00490490|P1|Participant Flow|Tositumomab + XRT + KI|Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
1128711|NCT00490490|O1|Outcome|Tositumomab + XRT + KI|Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
1128712|NCT00490490|O1|Outcome|Tositumomab + XRT + KI|Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
1128713|NCT00490490|O1|Outcome|Tositumomab + XRT + KI|Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
1128714|NCT00490490|E1|Reported Event|Tositumomab + XRT + KI|Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
1128715|NCT00490477|B3|Baseline|Total|Total of all reporting groups
1128716|NCT00490477|B2|Baseline|Polymyxin-B Hemoperfusion Treatment (PMX-B)|patients with Gram-negative severe sepsis treated with standard therapy, according to the Surviving Sepsis Campaign, and an extracorporeal therapy with a PMX-B filter that could remove LPS
1128717|NCT00490477|B1|Baseline|Conventional Treatment (CONV)|patients with Gram-negative severe sepsis who received standard care according to Surviving Sepsis Campaign guidelines
1128718|NCT00490477|P2|Participant Flow|Polymyxin-B Hemoperfusion Treatment (PMX-B)|patients with Gram-negative severe sepsis treated with standard therapy, according to the Surviving Sepsis Campaign, and an extracorporeal therapy with a PMX-B filter that could remove LPS
1128719|NCT00490477|P1|Participant Flow|Conventional Treatment (CONV)|patients with Gram-negative severe sepsis who received standard care according to Surviving Sepsis Campaign guidelines
1128720|NCT00490477|O2|Outcome|Polymyxin-B Hemoperfusion Treatment (PMX-B)|patients with Gram-negative severe sepsis treated with standard therapy, according to the Surviving Sepsis Campaign, and an extracorporeal therapy with a PMX-B filter that could remove LPS
1128721|NCT00490477|O1|Outcome|Conventional Treatment (CONV)|patients with Gram-negative severe sepsis who received standard care according to Surviving Sepsis Campaign guidelines
1128722|NCT00490477|E2|Reported Event|Polymyxin-B Hemoperfusion Treatment (PMX-B)|patients with Gram-negative severe sepsis treated with standard therapy, according to the Surviving Sepsis Campaign, and an extracorporeal therapy with a PMX-B filter that could remove LPS
1128723|NCT00490477|E1|Reported Event|Conventional Treatment (CONV)|patients with Gram-negative severe sepsis who received standard care according to Surviving Sepsis Campaign guidelines
1128724|NCT00490269|B3|Baseline|Total|Total of all reporting groups
1128725|NCT00490269|B2|Baseline|Placebo|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
1128726|NCT00490269|B1|Baseline|Dronabinol|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
1128727|NCT00490269|P2|Participant Flow|Placebo|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
1128728|NCT00490269|P1|Participant Flow|Dronabinol|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
1128847|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
1138843|NCT00464334|B12|Baseline|Total|Total of all reporting groups
1128729|NCT00490269|O2|Outcome|Placebo|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
1128791|NCT00490035|B3|Baseline|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
1128792|NCT00490035|B2|Baseline|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
1128730|NCT00490269|O1|Outcome|Dronabinol|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
1128731|NCT00490269|E2|Reported Event|Placebo|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
1128732|NCT00490269|E1|Reported Event|Dronabinol|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
1128733|NCT00490256|B3|Baseline|Total|Total of all reporting groups
1128734|NCT00490256|B2|Baseline|Experimental|This arm is the modified selective perfusion arm. This arm will receive the modified cardiopulmonary circuit.
1128735|NCT00490256|B1|Baseline|Control|Arm 1 is the control arm. This arm will receive the standard cardiopulmonary bypass circuit.
1128736|NCT00490256|P2|Participant Flow|Experimental|This arm is the modified selective perfusion arm. This arm will receive the modified cardiopulmonary circuit.
1128737|NCT00490256|P1|Participant Flow|Control|Arm 1 is the control arm. This arm will receive the standard cardiopulmonary bypass circuit.
1128738|NCT00490256|O2|Outcome|Experimental|This arm is the modified selective perfusion arm. This arm will receive the modified cardiopulmonary circuit.
1128739|NCT00490256|O1|Outcome|Control|Arm 1 is the control arm. This arm will receive the standard cardiopulmonary bypass circuit.
1128740|NCT00490256|E2|Reported Event|Experimental|This arm is the modified selective perfusion arm. This arm will receive the modified cardiopulmonary circuit.
1128741|NCT00490256|E1|Reported Event|Control|Arm 1 is the control arm. This arm will receive the standard cardiopulmonary bypass circuit.
1128742|NCT00490139|B5|Baseline|Total|Total of all reporting groups
1128743|NCT00490139|B4|Baseline|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128744|NCT00490139|B3|Baseline|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128745|NCT00490139|B2|Baseline|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128746|NCT00490139|B1|Baseline|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128747|NCT00490139|P4|Participant Flow|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128848|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
1128788|NCT00490061|E1|Reported Event|Radiotherapy (Radiation) and Lapatinib|Lapatinib, 1500mg once daily, was administered for 7 days prior to, and for the duration of Intensity Modulated Radio Therapy (IMRT), delivered by G.E. Healthcare 1.5T MR, systems revision 12.0 M5 for a total dose of 70Gy delivered in 2-2.12 Gy/ fraction over the course of 6.5-7 weeks.
1128789|NCT00490035|B5|Baseline|Total Title|
1128748|NCT00490139|P3|Participant Flow|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128749|NCT00490139|P2|Participant Flow|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128750|NCT00490139|P1|Participant Flow|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128751|NCT00490139|O4|Outcome|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128752|NCT00490139|O3|Outcome|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128753|NCT00490139|O2|Outcome|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128754|NCT00490139|O1|Outcome|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128755|NCT00490139|O4|Outcome|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128785|NCT00490061|P1|Participant Flow|Radiotherapy (Radiation) and Lapatinib|Lapatinib, 1500mg once daily, was administered for 7 days prior to, and for the duration of Intensity Modulated Radio Therapy (IMRT), delivered by G.E. Healthcare 1.5T MR, systems revision 12.0 M5 for a total dose of 70Gy delivered in 2-2.12 Gy/ fraction over the course of 6.5-7 weeks.
1128849|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1128850|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
1128756|NCT00490139|O3|Outcome|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128757|NCT00490139|O2|Outcome|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128758|NCT00490139|O1|Outcome|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128759|NCT00490139|O4|Outcome|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128760|NCT00490139|O3|Outcome|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128761|NCT00490139|O2|Outcome|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128762|NCT00490139|O1|Outcome|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128763|NCT00490139|O4|Outcome|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128786|NCT00490061|O1|Outcome|Radiotherapy (Radiation) and Lapatinib|Lapatinib, 1500mg once daily, was administered for 7 days prior to, and for the duration of Intensity Modulated Radio Therapy (IMRT), delivered by G.E. Healthcare 1.5T MR, systems revision 12.0 M5 for a total dose of 70Gy delivered in 2-2.12 Gy/ fraction over the course of 6.5-7 weeks.
1128851|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
1128764|NCT00490139|O3|Outcome|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128765|NCT00490139|O2|Outcome|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128766|NCT00490139|O1|Outcome|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128767|NCT00490139|O4|Outcome|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128768|NCT00490139|O3|Outcome|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128769|NCT00490139|O2|Outcome|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128770|NCT00490139|O1|Outcome|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128771|NCT00490139|O4|Outcome|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128787|NCT00490061|O1|Outcome|Radiotherapy (Radiation) and Lapatinib|Lapatinib, 1500mg once daily, was administered for 7 days prior to, and for the duration of Intensity Modulated Radio Therapy (IMRT), delivered by G.E. Healthcare 1.5T MR, systems revision 12.0 M5 for a total dose of 70Gy delivered in 2-2.12 Gy/ fraction over the course of 6.5-7 weeks.
1128772|NCT00490139|O3|Outcome|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128773|NCT00490139|O2|Outcome|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128774|NCT00490139|O1|Outcome|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128775|NCT00490139|E4|Reported Event|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128776|NCT00490139|E3|Reported Event|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128777|NCT00490139|E2|Reported Event|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128778|NCT00490139|E1|Reported Event|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
1128779|NCT00490100|B1|Baseline|Treatment|
1128780|NCT00490100|P1|Participant Flow|Treatment|Participants are young males with X-linked severe combined immunodeficiency complicated by growth failure. The participants will receive Insulin-like Growth Facor (Increlex) twice a day for up to 2 years.
1128781|NCT00490100|O1|Outcome|Treatment|Participants are young males with X-linked severe combined immunodeficiency complicated by growth failure. The participants will receive Insulin-like Growth Facor (Increlex) twice a day for up to 2 years.
1128782|NCT00490100|O1|Outcome|Treatment|"XSCID patients with growth failre treated with Increlex, recombinant human IGF-1.~Increlex"
1128783|NCT00490100|E1|Reported Event|Treatment|
1128784|NCT00490061|B1|Baseline|Radiotherapy (Radiation) and Lapatinib|"1500mg/d once daily oral lapatinib administration plus Intensity Modulated Radio Therapy (IMRT) delivered by G.E. Healthcare 1.5T MR, systems revision 12.0 M5 for a total dose of 70Gy delivered in 2-2.12 Gy/ fraction over the course of 6.5-7 weeks.~Lapatinib: 1500 mg po daily orally~Radiotherapy (radiation): Standard of Care~G.E. Healthcare 1.5T MR, systems revision 12.0 M5: Standard of Care, used to deliver IMRT~PET/CT: A subset of patients received imaging before and after treatment."
1128794|NCT00490035|P4|Participant Flow|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
1128795|NCT00490035|P3|Participant Flow|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
1128796|NCT00490035|P2|Participant Flow|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
1128797|NCT00490035|P1|Participant Flow|Placebo|Matching Placebo tablets administered twice a day
1128798|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
1128799|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
1128800|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
1128801|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1128802|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
1128803|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
1128804|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
1128805|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1128806|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
1128807|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
1128808|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
1128809|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1128810|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
1128811|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
1128812|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
1128813|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1128814|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
1128815|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
1128816|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
1128817|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1128818|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
1128819|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
1128820|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
1128821|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1128822|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
1128823|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
1128824|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
1128825|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1128826|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
1128827|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
1128828|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
1128829|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1128830|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
1128831|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
1128832|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
1128833|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1128834|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
1128835|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
1128836|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
1128837|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1128838|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
1128839|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
1128840|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
1128841|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1128842|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
1128843|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
1128844|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
1128845|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1128846|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
1128852|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
1128853|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1128854|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
1128855|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
1128856|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
1128857|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1128858|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
1128859|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
1128860|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
1128861|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1128862|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
1128863|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
1128864|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
1128865|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1128866|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
1128867|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
1128868|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
1128869|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1128870|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
1128871|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
1128872|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
1128873|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1128874|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
1128875|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
1128876|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
1128877|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1128878|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
1128879|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
1128880|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
1128881|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1128882|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
1128883|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
1128884|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
1128885|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1128886|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
1128887|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
1128888|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
1128889|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
1128890|NCT00490035|E4|Reported Event|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
1128891|NCT00490035|E3|Reported Event|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
1128892|NCT00490035|E2|Reported Event|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
1128893|NCT00490035|E1|Reported Event|Placebo|Matching Placebo tablets administered twice a day
1128894|NCT00490022|B3|Baseline|Total|Total of all reporting groups
1128895|NCT00490022|B2|Baseline|DHT Gel|DHT gel (70 mg/day) for one month
1128896|NCT00490022|B1|Baseline|Placebo DHT Gel|Placebo gel for one month
1128897|NCT00490022|P2|Participant Flow|DHT Gel|DHT gel (70 mg/day) for one month
1128898|NCT00490022|P1|Participant Flow|Placebo DHT Gel|Placebo gel for one month
1128899|NCT00490022|O2|Outcome|DHT Gel|DHT gel (70 mg/day) for one month
1128900|NCT00490022|O1|Outcome|Placebo DHT Gel|Placebo gel for one month
1128901|NCT00490022|O2|Outcome|DHT Gel|DHT gel (70 mg/day) for one month
1128902|NCT00490022|O1|Outcome|Placebo DHT Gel|Placebo gel for one month
1128903|NCT00490022|E2|Reported Event|DHT Gel|DHT gel (70 mg/day) for one month
1128904|NCT00490022|E1|Reported Event|Placebo DHT Gel|Placebo gel for one month
1128905|NCT00490009|B1|Baseline|Bexxar|Phase 2 study in patients with relapsed/refractory DLCL who were not candidates for transplantation. Bexxar was dosed as per the FDA approved regimen for other indications.
1128906|NCT00490009|P1|Participant Flow|Bexxar|Phase 2 study in patients with relapsed/refractory DLCL who were not candidates for transplantation. Bexxar was dosed as per the FDA approved regimen for other indications.
1128907|NCT00490009|O1|Outcome|Bexxar|Phase 2 study in patients with relapsed/refractory DLCL who were not candidates for transplantation. Bexxar was dosed as per the FDA approved regimen for other indications.
1128908|NCT00490009|O1|Outcome|Bexxar|Phase 2 study in patients with relapsed/refractory DLCL who were not candidates for transplantation. Bexxar was dosed as per the FDA approved regimen for other indications.
1128909|NCT00490009|O1|Outcome|Bexxar|Phase 2 study in patients with relapsed/refractory DLCL who were not candidates for transplantation. Bexxar was dosed as per the FDA-approved regimen for other indications.
1128976|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
1128910|NCT00490009|E1|Reported Event|Bexxar + Tylenol + Benadryl + SSKI|Bexxar is a radioimmunotherapeutic drug, an antibody that specifically attaches to the CD20 antigen, which is present on the surfaces of B cells and B cell lymphoma cells. Bexxar is patient specific: 75 cGy whole body patients with platelet count of 150,000/mm³ and 65 cGy for patients with platelet count less than 150,000/mm³, IV
1128911|NCT00489970|B3|Baseline|Total|Total of all reporting groups
1128912|NCT00489970|B2|Baseline|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
1128985|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
1128913|NCT00489970|B1|Baseline|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
1128914|NCT00489970|P2|Participant Flow|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
1128915|NCT00489970|P1|Participant Flow|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
1128916|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
1128917|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
1128918|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
1128919|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
1128920|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
1128921|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
1128922|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
1128923|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
1128924|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
1128925|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
1128926|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
1128927|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
1128928|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
1128929|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
1128930|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
1128931|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
1128932|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
1128933|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
1128934|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
1128935|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
1128936|NCT00489970|E2|Reported Event|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
1128937|NCT00489970|E1|Reported Event|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
1128938|NCT00489866|B3|Baseline|Total|Total of all reporting groups
1128939|NCT00489866|B2|Baseline|Placebo|Identical to Aripiprazole
1128940|NCT00489866|B1|Baseline|Aripiprazole|Aripiprazole: 5 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-10 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-15 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-20 mg taken once a day orally for 2 weeks
1128941|NCT00489866|P2|Participant Flow|Placebo|Identical to Aripiprazole
1128942|NCT00489866|P1|Participant Flow|Aripiprazole|Aripiprazole: 5 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-10 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-15 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-20 mg taken once a day orally for 2 weeks
1128977|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
1128978|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
1128979|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
1128943|NCT00489866|O2|Outcome|Depression Symptoms Placebo Treated Group|The Beck Depression Inventory-II (BDI) is a very sensitive and widely used instrument used to detect depressive symptoms. It consists of 21 items that assess the intensity of depression in both clinical and non-clinical subjects. Each item is a list of four statements arranged in increasing severity regarding a particular symptom of depression.
1128986|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
1128987|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
1133735|NCT00477269|O1|Outcome|STI571|STI571
1128944|NCT00489866|O1|Outcome|Depression Symptoms Aripiprazole Treated Group|The Beck Depression Inventory-II (BDI) is a very sensitive and widely used instrument used to detect depressive symptoms. It consists of 21 items that assess the intensity of depression in both clinical and non-clinical subjects. Each item is a list of four statements arranged in increasing severity regarding a particular symptom of depression.
1128945|NCT00489866|O2|Outcome|Resilience Symptoms PlaceboTreated Group|This scale measures resilience. Range of scores (0-100). A score of 0 is suggestive of no resilience, a score of 100 is suggestive of high level of resilience.
1128946|NCT00489866|O1|Outcome|Resilience Symptoms Aripiprazole Treated Group|This scale measures resilience. Range of scores (0-100). A score of 0 is suggestive of no resilience, a score of 100 is suggestive of high level of resilience.
1128947|NCT00489866|O2|Outcome|Psychotic Symptoms Placebo Treated Group|The PANSS is a widely used measure with several subdomains, including positive symptoms, negative symptoms, and general psychopathology of schizophrenia. Lower scores are indicative of fewer symptoms; higher scores are indicative of more symptoms. Total PANSS scores range from 0-20.
1128948|NCT00489866|O1|Outcome|Psychotic Symptoms Aripiprazole Treated Group|The PANSS is a widely used measure with several subdomains, including positive symptoms, negative symptoms, and general psychopathology of schizophrenia. Lower scores are indicative of fewer symptoms; higher scores are indicative of more symptoms. Total PANSS scores range from 0-20.
1128949|NCT00489866|O2|Outcome|Cognitive Symptoms PlaceboTreated Group|The BACS includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3.
1128950|NCT00489866|O1|Outcome|Cognitive Symptoms Aripiprazole Treated Group|The BACS includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3.
1128951|NCT00489866|O2|Outcome|PTSD Symptoms Placebo Treated Group|The Clinician Administered PTSD Scale (CAPS) was used to measure changes in PTSD symptoms across the duration of the study.Mean change scores in posttraumatic stress disorder symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered). A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms.
1128952|NCT00489866|O1|Outcome|PTSD Symptoms Aripiprazole Treated Group|The Clinician Administered PTSD Scale (CAPS) was used to measure changes in PTSD symptoms across the duration of the study.Mean change scores in posttraumatic stress disorder symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered). A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms.
1128953|NCT00489866|E2|Reported Event|Placebo|Identical to Aripiprazole
1128954|NCT00489866|E1|Reported Event|Aripiprazole|Aripiprazole: 5 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-10 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-15 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-20 mg taken once a day orally for 2 weeks
1128955|NCT00489853|B1|Baseline|Entire Study Population|Cross over study with 3 Arms. (1)Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily. (2)Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily. (3) Placebo, 1 inhalation twice daily
1128956|NCT00489853|P3|Participant Flow|Placebo Then Formoterol Then Symbicort|Placebo, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
1128957|NCT00489853|P2|Participant Flow|Formoterol Then Symbicort Then Placebo|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily
1128958|NCT00489853|P1|Participant Flow|Symbicort Then Formoterol Then Placebo|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily
1128959|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
1128960|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
1128961|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
1128962|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
1128963|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
1128964|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
1128965|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
1128966|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
1128967|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
1128968|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
1128969|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
1128970|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
1128971|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
1128972|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
1128973|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
1128974|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
1128975|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
1128982|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
1128983|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
1128984|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
1133736|NCT00477269|O2|Outcome|Placebo|Placebo
1128988|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
1128989|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
1128990|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
1128991|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
1128992|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
1128993|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
1128994|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
1128995|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
1128996|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
1128997|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
1128998|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
1128999|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
1129000|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
1129001|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
1129002|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
1129003|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
1129004|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
1129005|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
1129006|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
1129007|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
1129008|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
1129009|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
1129010|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
1129011|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
1129012|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
1129013|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
1129014|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
1129015|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
1129016|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
1129017|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
1129018|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
1129019|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
1129020|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
1129021|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
1129022|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
1129023|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
1129024|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
1129025|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
1129026|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
1129027|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
1129028|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
1129029|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
1129030|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
1129031|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
1129032|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
1129033|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
1129034|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
1129035|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
1129036|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
1129037|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
1129038|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
1129039|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
1129040|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
1129041|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
1129042|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
1129043|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
1129044|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
1129045|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
1129046|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
1129047|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
1129048|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
1129049|NCT00489853|E3|Reported Event|Placebo|Placebo, 1 inhalation twice daily
1129050|NCT00489853|E2|Reported Event|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
1129051|NCT00489853|E1|Reported Event|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
1129052|NCT00489736|B3|Baseline|Total|Total of all reporting groups
1129053|NCT00489736|B2|Baseline|Amiodarone 600mg/200mg od|amiodarone 600mg once daily (od) for 28 days, then amiodarone 200mg once daily (od)
1129054|NCT00489736|B1|Baseline|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily (bid)
1129055|NCT00489736|P2|Participant Flow|Amiodarone 600mg/200mg od|amiodarone 600mg once daily (od) for 28 days, then amiodarone 200mg once daily (od)
1129056|NCT00489736|P1|Participant Flow|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily (bid)
1129057|NCT00489736|O2|Outcome|Amiodarone 600mg/200mg od|amiodarone 600mg once daily (od) for 28 days, then amiodarone 200mg once daily (od)
1129058|NCT00489736|O1|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily (bid)
1129059|NCT00489736|O2|Outcome|Amiodarone 600mg/200mg od|amiodarone 600mg once daily (od) for 28 days, then amiodarone 200mg once daily (od)
1129060|NCT00489736|O1|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily (bid)
1129061|NCT00489736|O2|Outcome|Amiodarone 600mg/200mg od|amiodarone 600mg once daily (od) for 28 days, then amiodarone 200mg once daily (od)
1129062|NCT00489736|O1|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily (bid)
1129063|NCT00489736|E2|Reported Event|Amiodarone 600mg/200mg od|amiodarone 600mg once daily (od) for 28 days, then amiodarone 200mg once daily (od)
1129064|NCT00489736|E1|Reported Event|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily (bid)
1129065|NCT00489554|B1|Baseline|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
1129066|NCT00489554|P1|Participant Flow|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
1129067|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
1129068|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
1129069|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
1129070|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
1129071|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
1129072|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
1129073|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
1129074|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
1129075|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
1129076|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
1129077|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
1129078|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
1129079|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
1129080|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
1129081|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
1129082|NCT00489554|E1|Reported Event|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
1129083|NCT00489541|B3|Baseline|Total|Total of all reporting groups
1129084|NCT00489541|B2|Baseline|Historical Control Bare Metal Stent (BMS)|The control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522).
1129085|NCT00489541|B1|Baseline|TAXUS Element|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
1129086|NCT00489541|P2|Participant Flow|Historical Control Bare Metal Stent (BMS)|The control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522).
1129087|NCT00489541|P1|Participant Flow|TAXUS Element|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
1129088|NCT00489541|O2|Outcome|Historical Control Bare Metal Stent (BMS)|The control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522).
1129089|NCT00489541|O1|Outcome|TAXUS Element|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
1129090|NCT00489541|O2|Outcome|Historical Control Bare Metal Stent (BMS)|The control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522).
1129091|NCT00489541|O1|Outcome|TAXUS Element|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
1129092|NCT00489541|E2|Reported Event|Historical Control Bare Metal Stent (BMS)|The control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522).
1129093|NCT00489541|E1|Reported Event|TAXUS Element|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
1129094|NCT00489489|B4|Baseline|Total|Total of all reporting groups
1129095|NCT00489489|B3|Baseline|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
1129096|NCT00489489|B2|Baseline|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
1129097|NCT00489489|B1|Baseline|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
1129098|NCT00489489|P3|Participant Flow|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
1129099|NCT00489489|P2|Participant Flow|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
1129100|NCT00489489|P1|Participant Flow|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
1129101|NCT00489489|O2|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with IFN-β for 24 weeks
1129102|NCT00489489|O1|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with IFN-β for 24 weeks
1129103|NCT00489489|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
1129104|NCT00489489|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
1129105|NCT00489489|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
1129106|NCT00489489|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
1129107|NCT00489489|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
1129108|NCT00489489|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
1129109|NCT00489489|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
1129110|NCT00489489|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
1129111|NCT00489489|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
1129112|NCT00489489|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
1129113|NCT00489489|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
1129114|NCT00489489|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
1129115|NCT00489489|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
1129116|NCT00489489|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
1129117|NCT00489489|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
1129118|NCT00489489|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
1129119|NCT00489489|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
1129120|NCT00489489|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
1129121|NCT00489489|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
1129122|NCT00489489|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
1129123|NCT00489489|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
1129124|NCT00489489|E3|Reported Event|Teriflunomide 14 mg + + IFN-β|Teriflunomide 14 mg once daily concomitantly with IFN-β for 24 weeks
1129125|NCT00489489|E2|Reported Event|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with IFN-β for 24 weeks
1129126|NCT00489489|E1|Reported Event|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with IFN-β for 24 weeks
1129127|NCT00489476|B5|Baseline|Total|Total of all reporting groups
1129128|NCT00489476|B4|Baseline|5 mg Staccato Loxapine|"5 mg ADASUVE, single dose~Staccato Loxapine"
1129129|NCT00489476|B3|Baseline|2.5 mg Staccato Loxapine|"2.5 mg ADASUVE, single dose~Staccato Loxapine"
1129130|NCT00489476|B2|Baseline|1.25 mg Staccato Loxapine|"1.25 mg ADASUVE, single dose~Staccato Loxapine"
1129131|NCT00489476|B1|Baseline|Staccato Placebo|"Staccato Placebo, 0 mg~Staccato Placebo: Placebo aerosol inhalation (0mg)"
1129132|NCT00489476|P4|Participant Flow|5 mg Staccato Loxapine|"5 mg ADASUVE, single dose~Staccato Loxapine"
1129133|NCT00489476|P3|Participant Flow|2.5 mg Staccato Loxapine|"2.5 mg ADASUVE, single dose~Staccato Loxapine"
1129134|NCT00489476|P2|Participant Flow|1.25 mg Staccato Loxapine|"1.25 mg ADASUVE, single dose~Staccato Loxapine"
1129135|NCT00489476|P1|Participant Flow|Staccato Placebo|"Staccato Placebo, 0 mg~Staccato Placebo: Placebo aerosol inhalation (0mg)"
1129136|NCT00489476|O4|Outcome|5 mg Staccato Loxapine|"5 mg ADASUVE, single dose~Staccato Loxapine"
1129137|NCT00489476|O3|Outcome|2.5 mg Staccato Loxapine|"2.5 mg ADASUVE, single dose~Staccato Loxapine"
1129138|NCT00489476|O2|Outcome|1.25 mg Staccato Loxapine|"1.25 mg ADASUVE, single dose~Staccato Loxapine"
1129139|NCT00489476|O1|Outcome|Staccato Placebo|"Staccato Placebo, 0 mg~Staccato Placebo: Placebo aerosol inhalation (0mg)"
1129140|NCT00489476|O4|Outcome|5 mg Staccato Loxapine|"5 mg ADASUVE, single dose~Staccato Loxapine"
1129141|NCT00489476|O3|Outcome|2.5 mg Staccato Loxapine|"2.5 mg ADASUVE, single dose~Staccato Loxapine"
1129142|NCT00489476|O2|Outcome|1.25 mg Staccato Loxapine|"1.25 mg ADASUVE, single dose~Staccato Loxapine"
1129143|NCT00489476|O1|Outcome|Staccato Placebo|"Staccato Placebo, 0 mg~Staccato Placebo: Placebo aerosol inhalation (0mg)"
1129144|NCT00489476|O4|Outcome|5 mg Staccato Loxapine|"5 mg ADASUVE, single dose~Staccato Loxapine"
1129145|NCT00489476|O3|Outcome|2.5 mg Staccato Loxapine|"2.5 mg ADASUVE, single dose~Staccato Loxapine"
1129146|NCT00489476|O2|Outcome|1.25 mg Staccato Loxapine|"1.25 mg ADASUVE, single dose~Staccato Loxapine"
1129147|NCT00489476|O1|Outcome|Staccato Placebo|"Staccato Placebo, 0 mg~Staccato Placebo: Placebo aerosol inhalation (0mg)"
1129148|NCT00489476|E4|Reported Event|5 mg Staccato Loxapine|"5 mg ADASUVE, single dose~Staccato Loxapine"
1129149|NCT00489476|E3|Reported Event|2.5 mg Staccato Loxapine|"2.5 mg ADASUVE, single dose~Staccato Loxapine"
1129150|NCT00489476|E2|Reported Event|1.25 mg Staccato Loxapine|"1.25 mg ADASUVE, single dose~Staccato Loxapine"
1129151|NCT00489476|E1|Reported Event|Staccato Placebo|"Staccato Placebo, 0 mg~Staccato Placebo: Placebo aerosol inhalation (0mg)"
1129152|NCT00489424|B4|Baseline|Total|Total of all reporting groups
1129153|NCT00489424|B3|Baseline|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
1129154|NCT00489424|B2|Baseline|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
1129155|NCT00489424|B1|Baseline|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
1129156|NCT00489424|P3|Participant Flow|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
1129157|NCT00489424|P2|Participant Flow|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
1129158|NCT00489424|P1|Participant Flow|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
1129159|NCT00489424|O3|Outcome|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
1129160|NCT00489424|O2|Outcome|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
1129161|NCT00489424|O1|Outcome|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
1129162|NCT00489424|O3|Outcome|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
1129163|NCT00489424|O2|Outcome|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
1129164|NCT00489424|O1|Outcome|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
1131105|NCT00485433|B3|Baseline|SKY0402 Middle Dose|SKY0402 middle dose given during hernia repair
1129165|NCT00489424|O3|Outcome|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
1129318|NCT00489216|O1|Outcome|Efalizumab|"All patients on study will receive a total of 8 injections of efalizumab~efalizumab: Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at~1mg/kg"
1129166|NCT00489424|O2|Outcome|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
1129167|NCT00489424|O1|Outcome|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
1129168|NCT00489424|O3|Outcome|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
1129169|NCT00489424|O2|Outcome|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
1129170|NCT00489424|O1|Outcome|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
1129171|NCT00489424|O3|Outcome|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
1129172|NCT00489424|O2|Outcome|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
1129173|NCT00489424|O1|Outcome|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
1129174|NCT00489424|O3|Outcome|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
1129175|NCT00489424|O2|Outcome|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
1129176|NCT00489424|O1|Outcome|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
1129177|NCT00489424|O3|Outcome|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
1129178|NCT00489424|O2|Outcome|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
1129179|NCT00489424|O1|Outcome|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
1129180|NCT00489424|O3|Outcome|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
1129181|NCT00489424|O2|Outcome|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
1129182|NCT00489424|O1|Outcome|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
1129362|NCT00488774|O4|Outcome|Golimumab 4 mg Per kg|Golimumab 4 mg per kg intravenous infusion was administered at Week 0.
1129183|NCT00489424|E3|Reported Event|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
1129184|NCT00489424|E2|Reported Event|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
1129185|NCT00489424|E1|Reported Event|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
1129186|NCT00489411|B3|Baseline|Total|Total of all reporting groups
1129187|NCT00489411|B2|Baseline|Arm II/Group B (Placebo Then Duloxetine)|Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
1129188|NCT00489411|B1|Baseline|Arm I/Group A (Duloxetine Then Placebo)|Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).
1129189|NCT00489411|P2|Participant Flow|Arm II/Group B (Placebo Then Duloxetine)|Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
1129190|NCT00489411|P1|Participant Flow|Arm I/Group A (Duloxetine Then Placebo)|Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).
1129191|NCT00489411|O2|Outcome|Arm II/Group B (Placebo Then Duloxetine)|Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
1129192|NCT00489411|O1|Outcome|Arm I/Group A (Duloxetine Then Placebo)|Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).
1129193|NCT00489411|O2|Outcome|Arm II/Group B (Placebo Then Duloxetine)|Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
1129194|NCT00489411|O1|Outcome|Arm I/Group A (Duloxetine Then Placebo)|Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).
1129209|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
1129363|NCT00488774|O3|Outcome|Golimumab 2 mg Per kg|Golimumab 2 mg per kg intravenous infusion was administered at Week 0.
1131106|NCT00485433|B2|Baseline|SKY0402 Low Dose|SKY0402 low dose given during hernia repair
1129210|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
1129195|NCT00489411|O2|Outcome|Arm II/Group B (Placebo Then Duloxetine)|Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
1129196|NCT00489411|O1|Outcome|Arm I/Group A (Duloxetine Then Placebo)|Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).
1129197|NCT00489411|O2|Outcome|Arm II/Group B (Placebo Then Duloxetine)|Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
1129198|NCT00489411|O1|Outcome|Arm I/Group A (Duloxetine Then Placebo)|Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).
1129199|NCT00489411|E2|Reported Event|Arm II/Group B (Placebo Then Duloxetine)|Patients will take one capsule of placebo orally daily for 7 days (week 1), and then increase to two capsules of placebo orally daily for 28 days (weeks 2-5). Placebo will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (duloxetine), and the sequence will be repeated. Patients will take one capsule of duloxetine daily for 7 days (week 8), two capsules of duloxetine daily for 28 days (weeks 9-12), one capsule of duloxetine daily for 7 days (week 13), and then no capsules for 7 days (week 14).
1129200|NCT00489411|E1|Reported Event|Arm I/Group A (Duloxetine Then Placebo)|Patients will take one capsule of 30 mg duloxetine orally daily for 7 days (week 1), and then increase to two capsules of duloxetine (60 mg duloxetine) orally daily for 28 days (weeks 2-5). Duloxetine will be tapered during week 6 (one capsule daily for 7 days), and will be discontinued during week 7 (no capsules for 7 days). Patients will then cross over to receive the alternative treatment (placebo), and the sequence will be repeated. Patients will take one capsule of placebo daily for 7 days (week 8), two capsules of placebo daily for 28 days (weeks 9-12), one capsule of placebo daily for 7 days (week 13), and then no capsules for 7 days (week 14).
1129201|NCT00489359|B3|Baseline|Total|Total of all reporting groups
1129202|NCT00489359|B2|Baseline|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
1129203|NCT00489359|B1|Baseline|Pemetrexed/Carboplatin Phase 1|Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin [area under the concentration-time curve (AUC) 5 or 6 mg/mL*min] was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion. Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level.
1129204|NCT00489359|P2|Participant Flow|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
1129205|NCT00489359|P1|Participant Flow|Pemetrexed/Carboplatin Phase 1|Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin [area under the concentration-time curve (AUC) 5 or 6 mg/mL*min] was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion. Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level.
1129206|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
1129207|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
1129208|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
1129211|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
1129212|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
1129213|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 1|"Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.~Carboplatin (AUC 5 or AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.~Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level."
1129214|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 1|"Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.~Carboplatin (AUC 5 or AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.~Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level."
1129215|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 1|"Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.~Carboplatin (AUC 5 or AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.~Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level."
1129216|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 1|"Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.~Carboplatin (AUC 5 or AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.~Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level."
1129217|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 1|"Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.~Carboplatin (AUC 5 or AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.~Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level."
1129218|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
1129219|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 1|"Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.~Carboplatin (AUC 5 or AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.~Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level."
1129220|NCT00489359|E7|Reported Event|Pemetrexed 500 + Carboplatin AUC 6 (Phase 2)|"Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.~Carboplatin (AUC 6) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion."
1129221|NCT00489359|E6|Reported Event|Pemetrexed 900 + Carboplatin AUC 6 (Phase 1)|"Pemetrexed (900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.~Carboplatin (AUC 6) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion."
1129222|NCT00489359|E5|Reported Event|Pemetrexed 800 + Carboplatin AUC 6 (Phase 1)|Pemetrexed (800 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
1129223|NCT00489359|E4|Reported Event|Pemetrexed 700 + Carboplatin AUC 6 (Phase 1)|Pemetrexed (700 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
1129224|NCT00489359|E3|Reported Event|Pemetrexed 600 + Carboplatin AUC 6 (Phase 1)|Pemetrexed (600 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
1129316|NCT00489216|O1|Outcome|Efalizumab|"All patients on study will receive a total of 8 injections of efalizumab~efalizumab: Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at~1mg/kg"
1129317|NCT00489216|O1|Outcome|Efalizumab|"All patients on study will receive a total of 8 injections of efalizumab~efalizumab: Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at~1mg/kg"
1129225|NCT00489359|E2|Reported Event|Pemetrexed 600 + Carboplatin AUC 5 (Phase 1)|Pemetrexed (600 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 5) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
1129226|NCT00489359|E1|Reported Event|Pemetrexed 500 + Carboplatin AUC 5 (Phase 1)|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 5) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
1129227|NCT00489268|B6|Baseline|Total|Total of all reporting groups
1129228|NCT00489268|B5|Baseline|Phase II|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
1129229|NCT00489268|B4|Baseline|Phase I: 12 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
1129230|NCT00489268|B3|Baseline|Phase I: 10 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
1129231|NCT00489268|B2|Baseline|Phase I: 8 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
1129232|NCT00489268|B1|Baseline|Phase I: 6 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
1129233|NCT00489268|P5|Participant Flow|Phase II|In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
1129234|NCT00489268|P4|Participant Flow|Phase I: 12 J/cm^2|In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
1129235|NCT00489268|P3|Participant Flow|Phase I: 10 J/cm^2|In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
1129236|NCT00489268|P2|Participant Flow|Phase I: 8 J/cm^2|In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
1129237|NCT00489268|P1|Participant Flow|Phase I: 6 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic Intestinal Metaplasia (IM), Low-Grade Dysplasia (LGD) and High-Grade Dysplasia (HGD). The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
1129354|NCT00488774|P4|Participant Flow|Golimumab 4 mg Per kg|Golimumab 4 mg per kg intavenous infusion was administered at Week 0.
1129355|NCT00488774|P3|Participant Flow|Golimumab 2 mg Per kg|Golimumab 2 mg per kg intravenous infusion was administered at Week 0.
1129238|NCT00489268|O5|Outcome|Phase II|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
1129239|NCT00489268|O4|Outcome|Phase I: 12 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
1129240|NCT00489268|O3|Outcome|Phase I: 10 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
1129241|NCT00489268|O2|Outcome|Phase I: 8 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
1129242|NCT00489268|O1|Outcome|Phase I: 6 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
1129243|NCT00489268|O5|Outcome|Phase II|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
1129244|NCT00489268|O4|Outcome|Phase I: 12 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
1129245|NCT00489268|O3|Outcome|Phase I: 10 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
1129356|NCT00488774|P2|Participant Flow|Golimumab 1 Milligram (mg) Per Kilogram (kg)|Golimumab 1 mg per kg intavenous infusion was administered at Week 0.
1129364|NCT00488774|O2|Outcome|Golimumab 1 mg Per kg|Golimumab 1 mg per kg intravenous infusion was administered at Week 0.
1129246|NCT00489268|O2|Outcome|Phase I: 8 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
1129247|NCT00489268|O1|Outcome|Phase I: 6 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
1129248|NCT00489268|O5|Outcome|Phase II|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
1129249|NCT00489268|O4|Outcome|Phase I: 12 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
1129250|NCT00489268|O3|Outcome|Phase I: 10 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
1129251|NCT00489268|O2|Outcome|Phase I: 8 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
1129252|NCT00489268|O1|Outcome|Phase I: 6 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
1129253|NCT00489268|O5|Outcome|Phase II|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
1129357|NCT00488774|P1|Participant Flow|Placebo|Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0.
1129358|NCT00488774|O4|Outcome|Golimumab 4 mg Per kg|Golimumab 4 mg per kg intravenous infusion was administered at Week 0.
1129254|NCT00489268|O4|Outcome|Phase I: 12 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
1129255|NCT00489268|O3|Outcome|Phase I: 10 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
1129256|NCT00489268|O2|Outcome|Phase I: 8 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
1129257|NCT00489268|O1|Outcome|Phase I: 6 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
1129258|NCT00489268|E5|Reported Event|Phase II|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
1129259|NCT00489268|E4|Reported Event|Phase I: 12 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
1129260|NCT00489268|E3|Reported Event|Phase I: 10 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
1129261|NCT00489268|E2|Reported Event|Phase I: 8 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
1129359|NCT00488774|O3|Outcome|Golimumab 2 mg Per kg|Golimumab 2 mg per kg intravenous infusion was administered at Week 0
1129360|NCT00488774|O2|Outcome|Golimumab 1 mg Per kg|Golimumab 1 mg per kg intravenous infusion was administered at Week 0.
1129262|NCT00489268|E1|Reported Event|Phase I: 6 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
1129263|NCT00489255|B3|Baseline|Total|Total of all reporting groups
1129264|NCT00489255|B2|Baseline|Placebo|Placebo : Oral capsule, three times daily.
1129265|NCT00489255|B1|Baseline|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
1129266|NCT00489255|P2|Participant Flow|Tigan:Placebo|Placebo : Oral capsule, three times daily.
1129267|NCT00489255|P1|Participant Flow|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
1129268|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
1129269|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
1129270|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
1129271|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
1129272|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
1129273|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
1129274|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
1129275|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
1129276|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
1129277|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
1129278|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
1129279|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
1129280|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
1129281|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
1129282|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
1129283|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
1129284|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
1129285|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
1129286|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
1129287|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
1129288|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
1129289|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
1129290|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
1129291|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
1129292|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
1129293|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
1129294|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
1129295|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
1129296|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
1129297|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
1129298|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
1129299|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
1129300|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
1129301|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
1129302|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
1129303|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
1129304|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
1129305|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
1129306|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
1129307|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
1129308|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
1129309|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
1129310|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
1129311|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
1129312|NCT00489255|E2|Reported Event|Placebo|Placebo : Oral capsule, three times daily.
1129313|NCT00489255|E1|Reported Event|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
1129314|NCT00489216|B1|Baseline|Efalizumab|"All patients on study will receive a total of 8 injections of efalizumab~efalizumab: Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at~1mg/kg"
1129315|NCT00489216|P1|Participant Flow|Efalizumab|"All patients on study will receive a total of 8 injections of efalizumab~efalizumab: Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at~1mg/kg"
1129361|NCT00488774|O1|Outcome|Placebo|Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0.
1129319|NCT00489216|O1|Outcome|Efalizumab|"All patients on study will receive a total of 8 injections of efalizumab~efalizumab: Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at~1mg/kg"
1129320|NCT00489216|O1|Outcome|Efalizumab|"All patients on study will receive a total of 8 injections of efalizumab~efalizumab: Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at~1mg/kg"
1129321|NCT00489216|O1|Outcome|Efalizumab|"All patients on study will receive a total of 8 injections of efalizumab~efalizumab: Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at~1mg/kg"
1129322|NCT00489216|E1|Reported Event|Efalizumab|"All patients on study will receive a total of 8 injections of efalizumab~efalizumab: Efalizumab will be administered as a subcutaneous injection once a week for 8 weeks (total of 8 doses). First efalizumab injection will be dosed at 0.7mg/kg. Subsequent weekly injections given on days 8-50 will be dosed at~1mg/kg"
1129323|NCT00489086|B1|Baseline|Tazarotene Cream|This is a 36 month, multi-center, single arm, open label clinical study design
1129324|NCT00489086|P1|Participant Flow|Tazarotene Cream|This is a 36 month, multi-center, single arm, open label clinical study design
1129325|NCT00489086|O1|Outcome|Tazarotene Cream|This is a 36 month, multi-center, single arm, open label clinical study design
1129326|NCT00489086|E1|Reported Event|Tazarotene Cream|This is a 36 month, multi-center, single arm, open label clinical study design
1129327|NCT00488865|B1|Baseline|Option IVC Filter Device Placement|All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
1129328|NCT00488865|P1|Participant Flow|Option IVC Filter Device Placement|All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
1129329|NCT00488865|O1|Outcome|Option IVC Filter Device Placement|All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
1129330|NCT00488865|O1|Outcome|Option IVC Filter Device Placement|All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
1129331|NCT00488865|O1|Outcome|Option IVC Filter Device Placement|All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
1129332|NCT00488865|E1|Reported Event|Option IVC Filter Device Placement|All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
1129333|NCT00488826|B4|Baseline|Total|Total of all reporting groups
1129334|NCT00488826|B3|Baseline|DTaP Alone|DTaP administered at 3, 4, and 5 months of age.
1129335|NCT00488826|B2|Baseline|7vPnC + DTaP Concurrently|7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.
1129336|NCT00488826|B1|Baseline|7vPnC Separately|7-valent pneumococcal conjugate vaccine (7vPnC) administered at 3, 4, and 5 months of age. Diphtheria and tetanus toxoids and accelular pertussis vaccine (DTaP) administered at least 7 days after 7vPnC at 3, 4, and 5 months of age.
1129337|NCT00488826|P3|Participant Flow|DTaP Alone|DTaP administered at 3, 4, and 5 months of age.
1129338|NCT00488826|P2|Participant Flow|7vPnC + DTaP Concurrently|7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.
1129339|NCT00488826|P1|Participant Flow|7vPnC Separately|7-valent pneumococcal conjugate vaccine (7vPnC) administered at 3, 4, and 5 months of age. Diphtheria and tetanus toxoids and accelular pertussis vaccine (DTaP) administered at least 7 days after 7vPnC at 3, 4, and 5 months of age.
1129340|NCT00488826|O3|Outcome|DTaP Alone|DTaP administered at 3, 4, and 5 months of age.
1129341|NCT00488826|O2|Outcome|7vPnC + DTaP Concurrently|7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.
1129342|NCT00488826|O1|Outcome|7vPnC Separately|7-valent pneumococcal conjugate vaccine (7vPnC) administered at 3, 4, and 5 months of age. Diphtheria and tetanus toxoids and accelular pertussis vaccine (DTaP) administered at least 7 days after 7vPnC at 3, 4, and 5 months of age.
1129343|NCT00488826|O3|Outcome|DTaP Alone|DTaP administered at 3, 4, and 5 months of age.
1129344|NCT00488826|O2|Outcome|7vPnC + DTaP Concurrently|7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.
1129345|NCT00488826|O1|Outcome|7vPnC Separately|7-valent pneumococcal conjugate vaccine (7vPnC) administered at 3, 4, and 5 months of age. Diphtheria and tetanus toxoids and accelular pertussis vaccine (DTaP) administered at least 7 days after 7vPnC at 3, 4, and 5 months of age.
1129346|NCT00488826|E3|Reported Event|DTaP Alone|DTaP administered at 3, 4, and 5 months of age.
1129347|NCT00488826|E2|Reported Event|7vPnC + DTaP Concurrently|7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.
1129348|NCT00488826|E1|Reported Event|7vPnC Separately|7-valent pneumococcal conjugate vaccine (7vPnC) administered at 3, 4, and 5 months of age. Diphtheria and tetanus toxoids and accelular pertussis vaccine (DTaP) administered at least 7 days after 7vPnC at 3, 4, and 5 months of age.
1129349|NCT00488774|B5|Baseline|Total|Total of all reporting groups
1129350|NCT00488774|B4|Baseline|Golimumab 4 mg Per kg|Golimumab 4 mg per kg intavenous infusion was administered at Week 0.
1129351|NCT00488774|B3|Baseline|Golimumab 2 mg Per kg|Golimumab 2 mg per kg intravenous infusion was administered at Week 0.
1129352|NCT00488774|B2|Baseline|Golimumab 1 mg Per kg|Golimumab 1 mg per kg intavenous infusion was administered at Week 0.
1129353|NCT00488774|B1|Baseline|Placebo|Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0.
1140869|NCT00460239|O2|Outcome|Morphine 15 mg|
1129365|NCT00488774|O1|Outcome|Placebo|Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0.
1129366|NCT00488774|E4|Reported Event|Golimumab 4 mg Per kg|Golimumab 4 mg per kg intravenous infusion was administered at Week 0.
1129367|NCT00488774|E3|Reported Event|Golimumab 2 mg Per kg|Golimumab 2 mg per kg intravenous infusion was administered at Week 0.
1129368|NCT00488774|E2|Reported Event|Golimumab 1 mg Per kg|Golimumab 1 mg per kg intravenous infusion was administered at Week 0.
1129545|NCT00488514|O2|Outcome|15-17 Years|Participants who were 15-17 years old at the time of the Screening Visit
1129369|NCT00488774|E1|Reported Event|Placebo|Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0.
1129370|NCT00488683|B4|Baseline|Total|Total of all reporting groups
1129371|NCT00488683|B3|Baseline|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
1129372|NCT00488683|B2|Baseline|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
1129373|NCT00488683|B1|Baseline|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
1129374|NCT00488683|P3|Participant Flow|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
1129375|NCT00488683|P2|Participant Flow|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
1129376|NCT00488683|P1|Participant Flow|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
1129377|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
1129378|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
1129379|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
1129380|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
1129381|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
1129382|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
1129383|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
1129384|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
1129401|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
1129385|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
1129546|NCT00488514|O1|Outcome|12-14 Years|Participants who were 12-14 years old at the time of the Screening Visit
1129386|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
1129387|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
1129388|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
1129389|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
1129390|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
1129391|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
1129392|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
1129393|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
1129394|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
1129395|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
1129396|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
1129397|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
1129398|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
1129399|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
1129400|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
1129506|NCT00488514|O2|Outcome|6 Month Completer Population|Participant in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
1129402|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
1131375|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
1129403|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
1129404|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
1129405|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
1129406|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
1129407|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
1129408|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
1129409|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
1129410|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines – 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
1129411|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines – 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
1129412|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines – 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
1129413|NCT00488683|O3|Outcome|MenACWY-CRM + Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
1129414|NCT00488683|O2|Outcome|MenACWY-CRM + Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
1129415|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
1129416|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
1129417|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
1129418|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
1129439|NCT00488631|B6|Baseline|GLM-I-nonRsp-Golimumab 100 mg Maintenance|Participants not in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
1129419|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
1129420|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
1129421|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
1129422|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
1129423|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
1129424|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
1129425|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
1129426|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
1129427|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
1129428|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
1129429|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
1129430|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
1129431|NCT00488683|E3|Reported Event|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
1129432|NCT00488683|E2|Reported Event|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
1129433|NCT00488683|E1|Reported Event|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
1129434|NCT00488644|B1|Baseline|Levothyroxine + Liothyronine|Levothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks
1129435|NCT00488644|P1|Participant Flow|Levothyroxine + Liothyronine|Levothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks
1129436|NCT00488644|O1|Outcome|8 Weeks Post Therapy|Levothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks.
1129437|NCT00488644|E1|Reported Event|Levothyroxine + Liothyronine|Levothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks
1129438|NCT00488631|B7|Baseline|Total|Total of all reporting groups
1129440|NCT00488631|B5|Baseline|PBO-I-nonRsp-Golimumab 100 mg Maintenance|Participants not in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
1129441|NCT00488631|B4|Baseline|Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance|Participants in clinical response to placebo at Week 6 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
1129442|NCT00488631|B3|Baseline|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
1129443|NCT00488631|B2|Baseline|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
1129444|NCT00488631|B1|Baseline|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
1129445|NCT00488631|P10|Participant Flow|Golimumab 200 mg Extension|Participants entered the study extension at Week 54 receiving golimumab 200 mg subcutaneous injection administered every 4 weeks. With Amendment 3 participants remaining on golimumab 200 mg had their dose decreased to golimumab 100 mg subcutaneous injection administered every 4 weeks.
1129446|NCT00488631|P9|Participant Flow|Golimumab 100 mg Extension|Participants entered the study extension at Week 54 receiving golimumab 100 mg subcutaneous injection administered every 4 weeks; prior to Amendment 3 , those whose UC disease worsened had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks.
1129447|NCT00488631|P8|Participant Flow|Golimumab 50 mg - Extension|Participants entered the study extension at Week 54 receiving golimumab 50 mg subcutaneous injection administered every 4 weeks; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks.
1129448|NCT00488631|P7|Participant Flow|Placebo Extension|Participants entered the study extension at Week 54 receiving placebo subcutaneous injection administered every 4 weeks until study unblinding and discontinuation of participants remaining on placebo; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks in the study extension.
1129449|NCT00488631|P6|Participant Flow|GLM-I-nonRsp-Golimumab 100 mg Maintenance|Participants not in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
1129450|NCT00488631|P5|Participant Flow|PBO-I-nonRsp-Golimumab 100 mg Maintenance|Participants not in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
1129451|NCT00488631|P4|Participant Flow|Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance|Participants in clinical response to placebo at Week 6 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
1129452|NCT00488631|P3|Participant Flow|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
1129453|NCT00488631|P2|Participant Flow|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
1129507|NCT00488514|O1|Outcome|ITT Population|Participants in the Enrolled Population who took at least one dose of the combination tablet and had at least one post-treatment migraine assessment
1129509|NCT00488514|O2|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
1131376|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
1129454|NCT00488631|P1|Participant Flow|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
1129455|NCT00488631|O3|Outcome|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
1129456|NCT00488631|O2|Outcome|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
1129457|NCT00488631|O1|Outcome|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
1129458|NCT00488631|O3|Outcome|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
1129459|NCT00488631|O2|Outcome|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
1129460|NCT00488631|O1|Outcome|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
1129461|NCT00488631|O3|Outcome|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
1129462|NCT00488631|O2|Outcome|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
1129463|NCT00488631|O1|Outcome|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
1129464|NCT00488631|O3|Outcome|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
1129465|NCT00488631|O2|Outcome|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
1129542|NCT00488514|O2|Outcome|15-17 Years|Participants who were 15-17 years old at the time of the Screening Visit
1140870|NCT00460239|O1|Outcome|Placebo 0 mg|
1129466|NCT00488631|O1|Outcome|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
1129467|NCT00488631|O3|Outcome|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
1129468|NCT00488631|O2|Outcome|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
1129469|NCT00488631|O1|Outcome|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
1129470|NCT00488631|E18|Reported Event|Golimumab 100 mg - 200 mg Extension|Participants entered the study extension receiving golimumab 100 mg subcutaneous injection administered every 4 weeks and had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks upon worsening of UC disease. Adverse events are presented from the time of dose adjustment.
1129471|NCT00488631|E17|Reported Event|Golimumab 50 mg - 100 mg Extension|Participants entered the study extension receiving golimumab 50 mg subcutaneous injection administered every 4 weeks and had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks upon worsening of UC disease. Adverse events are presented from the time of dose adjustment
1129472|NCT00488631|E16|Reported Event|Placebo - Golimumab100 mg Extension|Participants entered the study extension receiving placebo subcutaneous injection administered every 4 weeks and had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks upon worsening of UC disease in the study extension. Adverse events are presented from the time of dose adjustment.
1129473|NCT00488631|E15|Reported Event|Placebo - 50 mg Extension|A single participant entered the study extension receiving placebo subcutaneous injection administered every 4 weeks; and on worsening of UC disease had their dose increased to golimumab 50 mg subcutaneous injection administered every 4 weeks in the study extension. Adverse events are presented from the time of dose adjustment.
1129474|NCT00488631|E14|Reported Event|Golimumab 200 mg Extension|Participants entered the study extension receiving golimumab 200 mg subcutaneous injection administered every 4 weeks. With Amendment 3 participants remaining golimumab 200 mg had their dose descreased to golimumab 100 mg subcutaneous injection administered every 4 weeks. Adverse events are presented from Week 54.
1129475|NCT00488631|E13|Reported Event|Golimumab 100 mg Extension|Participants entered the study extension receiving golimumab 100 mg subcutaneous injection administered every 4 weeks; prior to Amendment 3 , those whose UC disease worsened had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks. Adverse events are presented from Week 54 up to Week 228 or the time of dose adjustment for subjects who increased dose.
1129476|NCT00488631|E12|Reported Event|Golimumab 50 mg Extension Phase|Participants entered the study extension receiving golimumab 50 mg subcutaneous injection administered every 4 weeks; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks. Adverse events are presented from Week 54 up to Week 228 or the time of dose adjustment for subjects who increased dose.
1129477|NCT00488631|E11|Reported Event|Placebo Extension|Participants entered the study extension receiving placebo subcutaneous injection administered every 4 weeks until study unblinding and discontinuation of participants remaining on placebo; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks in the study extension. Adverse events are presented from Week 54 up to Week 228 or the time of dose adjustment for subjects who increased dose.
1129478|NCT00488631|E10|Reported Event|PBO-I-Rsp-Placebo Maintenance-Golimumab 100 mg|Participants in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631) and had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 on loss of clinical response; not randomized. Adverse events are presented from the time of dose adjustment onwards up to Week 54.
1129479|NCT00488631|E9|Reported Event|GLM-I-nonRsp-Golimumab 100 mg Maintenance|Participants not in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Adverse events are presented through Week 54.
1129480|NCT00488631|E8|Reported Event|PBO-I-nonRsp-Golimumab 100 mg Maintenance|Participants not in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Adverse events are presented through Week 54.
1129508|NCT00488514|O3|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
1129481|NCT00488631|E7|Reported Event|Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance|Participants in clinical response to placebo at Week 6 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Adverse events are presented through Week 54. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
1129482|NCT00488631|E6|Reported Event|GLM-I-Rsp-Golimumab 100 mg Maintenance-Golimumab 200 mg|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631), and had their dose increased to golimumab 200 mg subcutaneous injection every 4 weeks through Week 52 on loss of clinical response. Adverse events are presented from the time of dose adjustment onwards up to Week 54.
1129483|NCT00488631|E5|Reported Event|GLM-I-Rsp-Golimumab 50 mg Maintenance-Golimumab 100 mg|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631), and had their dose increased to golimumab 100 mg subcutaneous injection every 4 weeks through Week 52 on loss of clinical response Adverse events are presented from the time of dose adjustment onwards up to Week 54.
1129484|NCT00488631|E4|Reported Event|GLM-I-Rsp-Placebo Maintenance-Golimumab 100 mg|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631), and had their dose increased to golimumab 100 mg subcutaneous injection every 4 weeks through Week 52 on loss of clinical response Adverse events are presented from the time of dose adjustment onwards up to Week 54.
1129485|NCT00488631|E3|Reported Event|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
1129486|NCT00488631|E2|Reported Event|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Adverse events are presented through Week 54.Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
1129487|NCT00488631|E1|Reported Event|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
1129488|NCT00488618|B3|Baseline|Total|Total of all reporting groups
1129489|NCT00488618|B2|Baseline|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
1129490|NCT00488618|B1|Baseline|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
1129491|NCT00488618|P2|Participant Flow|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
1129492|NCT00488618|P1|Participant Flow|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
1129493|NCT00488618|O2|Outcome|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
1129494|NCT00488618|O1|Outcome|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
1129495|NCT00488618|O2|Outcome|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
1129496|NCT00488618|O1|Outcome|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
1129497|NCT00488618|E2|Reported Event|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
1129498|NCT00488618|E1|Reported Event|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
1129499|NCT00488592|B1|Baseline|WT1/PR1 Vaccine|Subjects with myeloid malignacies will receive Wilms' tumor (WT1)/ pathogenesis- related 1 (PR1) vaccine to evaluate an immune response to the intervention
1129500|NCT00488592|P1|Participant Flow|WT1/PR1|Subjects with myeloid malignacies will receive Wilms' tumor (WT1)/ pathogenesis- related 1 (PR1) vaccine to evaluate an immune response to the intervention
1129501|NCT00488592|O1|Outcome|WT1/PR1 Vaccine|Subjects with myeloid malignancies will receive WT1/PR1 vaccine to evaluate immune response to intervention.
1129502|NCT00488592|E1|Reported Event|WT1/ PR1 Vaccine|Subjects with myeloid malignacies will receive Wilms' tumor (WT1)/ pathogenesis- related 1 (PR1) vaccine to evaluate an immune response to the intervention
1129503|NCT00488514|B1|Baseline|85 mg Sumatriptan/500 mg Naproxen Sodium|Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium.
1129504|NCT00488514|P1|Participant Flow|85 mg Sumatriptan/500 mg Naproxen Sodium|Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium. A single Combination Tablet was supplied for each migraine attack, not to exceed one tablet in 24 hours.
1129505|NCT00488514|O3|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
1129510|NCT00488514|O1|Outcome|ITT Population|Participants in the Enrolled Population who took at least one dose of the combination tablet drug and had at least one post-treatment migraine assessment
1129511|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
1129512|NCT00488514|O1|Outcome|ITT Population|Participants in the Enrolled Population who took at least one dose of the combination tablet and had at least one post-treatment migraine assessment
1129513|NCT00488514|O3|Outcome|ITT Population|Participants in the Enrolled Population who took at least one dose of the combination tablet and had at least one post-treatment migraine assessment
1129514|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
1129515|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
1129516|NCT00488514|O3|Outcome|ITT Population|Participants in the Enrolled Population who took at least one dose of the combination tablet and had at least one post-treatment migraine assessment
1129517|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
1129518|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
1129519|NCT00488514|O3|Outcome|ITT Population|Participants in the Enrolled Population who took at least one dose of the combination tablet and had at least one post-treatment migraine assessment
1129520|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
1129521|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
1129522|NCT00488514|O3|Outcome|ITT Population|Participants in the Enrolled Population who took at least one dose of the combination tablet and had at least one post-treatment migraine assessment
1129523|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
1129524|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
1129525|NCT00488514|O1|Outcome|85 mg Sumatriptan/500 mg Naproxen Sodium|Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium
1129526|NCT00488514|O1|Outcome|85 mg Sumatriptan/500 mg Naproxen Sodium|Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium
1129527|NCT00488514|O1|Outcome|85 mg Sumatriptan/500 mg Naproxen Sodium|
1129528|NCT00488514|O1|Outcome|85 mg Sumatriptan/500 mg Naproxen Sodium|Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium
1129529|NCT00488514|O3|Outcome|12-17 Years|All participants in the Enrolled Population who took at least one dose of study drug
1129530|NCT00488514|O2|Outcome|15-17 Years|Participants who were 15-17 years old at the time of the Screening Visit
1129531|NCT00488514|O1|Outcome|12-14 Years|Participants who were 12-14 years old at the time of the Screening Visit
1129532|NCT00488514|O3|Outcome|12-17 Years|All participants in the Enrolled Population who took at least one dose of study drug
1129533|NCT00488514|O2|Outcome|15-17 Years|Participants who were 15-17 years old at the time of the Screening Visit
1129534|NCT00488514|O1|Outcome|12-14 Years|Participants who were 12-14 years old at the time of the Screening Visit
1129535|NCT00488514|O3|Outcome|12-17 Years|All participants in the Enrolled Population who took at least one dose of study drug
1129536|NCT00488514|O2|Outcome|15-17 Years|Participants who were 15-17 years old at the time of the Screening Visit
1129537|NCT00488514|O1|Outcome|12-14 Years|Participants who were 12-14 years old at the time of the Screening Visit
1129538|NCT00488514|O3|Outcome|12-17 Years|All participants in the Enrolled Population who took at least one dose of study drug
1129539|NCT00488514|O2|Outcome|15-17 Years|Participants who were 15-17 years old at the time of the Screening Visit
1129540|NCT00488514|O1|Outcome|12-14 Years|Participants who were 12-14 years old at the time of the Screening Visit
1129541|NCT00488514|O3|Outcome|12-17 Years|All participants in the Enrolled Population who took at least one dose of study drug
1131107|NCT00485433|B1|Baseline|Bupivacaine HCl 105mg|Bupivacaine HCl given during hernia repair
1129543|NCT00488514|O1|Outcome|12-14 Years|Participants who were 12-14 years old at the time of the Screening Visit
1129544|NCT00488514|O3|Outcome|12-17 Years|All participants in the Enrolled Population who took at least one dose of study drug
1129547|NCT00488514|O3|Outcome|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
1129548|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
1129549|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
1129550|NCT00488514|O3|Outcome|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
1129551|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
1129552|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
1129553|NCT00488514|O3|Outcome|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
1129554|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
1129555|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet , completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
1129556|NCT00488514|O3|Outcome|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
1129557|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
1129558|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
1129559|NCT00488514|O1|Outcome|85 mg Sumatriptan/500 mg Naproxen Sodium|Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium
1129560|NCT00488514|O1|Outcome|85 mg Sumatriptan/500 mg Naproxen Sodium|Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium.
1129561|NCT00488514|O3|Outcome|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
1129562|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
1129563|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
1129564|NCT00488514|O3|Outcome|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
1129565|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
1129566|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
1129567|NCT00488514|O3|Outcome|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
1129568|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
1129569|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
1129570|NCT00488514|O3|Outcome|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
1129571|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
1129633|NCT00488345|O3|Outcome|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
1129572|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
1129573|NCT00488514|E3|Reported Event|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
1129574|NCT00488514|E2|Reported Event|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
1129575|NCT00488514|E1|Reported Event|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
1129576|NCT00488488|B1|Baseline|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
1129577|NCT00488488|P1|Participant Flow|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
1129578|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
1129579|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
1129580|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
1129581|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
1129582|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
1129583|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
1129584|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
1129585|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
1129586|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
1129587|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
1129588|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
1129589|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
1129590|NCT00488488|E1|Reported Event|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
1129591|NCT00488475|B1|Baseline|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
1129592|NCT00488475|P1|Participant Flow|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
1129593|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
1129594|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
1129595|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
1129596|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
1129597|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
1129598|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
1129630|NCT00488345|O3|Outcome|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
1131108|NCT00485433|P4|Participant Flow|SKY0402 High Dose|SKY0402 high dose given during hernia repair
1129599|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
1131377|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
1129600|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
1129601|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
1129602|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
1129603|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
1129604|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
1129605|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
1129606|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
1129607|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
1129608|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
1129609|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
1129610|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
1129611|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
1129612|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
1129613|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
1129614|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
1129615|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
1129616|NCT00488475|E1|Reported Event|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
1129617|NCT00488345|B4|Baseline|Total|Total of all reporting groups
1129618|NCT00488345|B3|Baseline|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
1129619|NCT00488345|B2|Baseline|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
1129620|NCT00488345|B1|Baseline|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
1129621|NCT00488345|P3|Participant Flow|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
1129622|NCT00488345|P2|Participant Flow|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
1129623|NCT00488345|P1|Participant Flow|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
1129624|NCT00488345|O1|Outcome|Tigecycline 0.75 mg/kg, 1 mg/kg, 1.25 mg/kg|0.75, 1 mg/kg, and 1.25 milligram per kilogram (mg/kg) intravenous (IV) infusions every 12 hours
1129625|NCT00488345|O1|Outcome|Tigecycline 0.75 mg/kg, 1 mg/kg, 1.25 mg/kg|0.75, 1 mg/kg, and 1.25 milligram per kilogram (mg/kg) intravenous (IV) infusions every 12 hours
1129626|NCT00488345|O3|Outcome|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
1129627|NCT00488345|O2|Outcome|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
1129628|NCT00488345|O1|Outcome|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
1129629|NCT00488345|O1|Outcome|Tigecycline 0.75 mg/kg, 1 mg/kg, 1.25 mg/kg|0.75, 1 mg/kg, and 1.25 milligram per kilogram (mg/kg) intravenous (IV) infusions every 12 hours
1129631|NCT00488345|O2|Outcome|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
1129632|NCT00488345|O1|Outcome|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
1129634|NCT00488345|O2|Outcome|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
1129635|NCT00488345|O1|Outcome|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
1129636|NCT00488345|O3|Outcome|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
1129637|NCT00488345|O2|Outcome|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
1129638|NCT00488345|O1|Outcome|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
1129639|NCT00488345|O3|Outcome|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
1129640|NCT00488345|O2|Outcome|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
1129641|NCT00488345|O1|Outcome|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
1129642|NCT00488345|E3|Reported Event|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
1129643|NCT00488345|E2|Reported Event|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
1129644|NCT00488345|E1|Reported Event|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
1129645|NCT00488319|B4|Baseline|Total|Total of all reporting groups
1129646|NCT00488319|B3|Baseline|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129647|NCT00488319|B2|Baseline|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129648|NCT00488319|B1|Baseline|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129649|NCT00488319|P3|Participant Flow|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129650|NCT00488319|P2|Participant Flow|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129651|NCT00488319|P1|Participant Flow|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129652|NCT00488319|O4|Outcome|Total|
1129653|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129654|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129768|NCT00488059|O1|Outcome|Phase I: ENF 90mg SC BID|(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
1131109|NCT00485433|P3|Participant Flow|SKY0402 Middle Dose|SKY0402 middle dose given during hernia repair
1129780|NCT00488059|E1|Reported Event|Phase I: ENF 90mg SC BID|(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
1129655|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129656|NCT00488319|O4|Outcome|Total|
1129657|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129658|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129659|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129660|NCT00488319|O4|Outcome|Total|
1129661|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129662|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129663|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129664|NCT00488319|O4|Outcome|Total|
1129665|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129666|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129667|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129668|NCT00488319|O4|Outcome|Total|
1129669|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129670|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129671|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129672|NCT00488319|O4|Outcome|Total|
1129673|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129674|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129675|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129676|NCT00488319|O4|Outcome|Total|
1129677|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129678|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129679|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129680|NCT00488319|O4|Outcome|Total|
1129681|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129682|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129683|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129684|NCT00488319|O4|Outcome|Total|
1129685|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129686|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129687|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129688|NCT00488319|O4|Outcome|Total|
1129689|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129690|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129691|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129692|NCT00488319|O4|Outcome|Total|
1129693|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129694|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129695|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129696|NCT00488319|O4|Outcome|Total|
1129697|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129698|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129699|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129700|NCT00488319|O4|Outcome|Total|
1129701|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129702|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129703|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129704|NCT00488319|O4|Outcome|Total|
1129705|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129706|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129707|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129708|NCT00488319|O4|Outcome|Total|
1129709|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129710|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129711|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129712|NCT00488319|O4|Outcome|Total|
1129713|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129714|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129715|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129716|NCT00488319|O4|Outcome|Total|
1129717|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129718|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129719|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129720|NCT00488319|O4|Outcome|Total|
1129721|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129722|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129723|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129724|NCT00488319|O4|Outcome|Total|
1129725|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129726|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129727|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129728|NCT00488319|O4|Outcome|Total|
1129729|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129730|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129731|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129732|NCT00488319|E3|Reported Event|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129733|NCT00488319|E2|Reported Event|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129734|NCT00488319|E1|Reported Event|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
1129735|NCT00488293|B3|Baseline|Total|Total of all reporting groups
1129736|NCT00488293|B2|Baseline|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
1129737|NCT00488293|B1|Baseline|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
1129738|NCT00488293|P2|Participant Flow|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
1129739|NCT00488293|P1|Participant Flow|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
1129740|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
1129741|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
1129742|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
1129743|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
1129744|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
1129745|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
1129746|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
1129747|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
1129748|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
1129749|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
1129750|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
1129751|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
1129752|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
1129753|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
1129754|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
1129755|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
1129756|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
1129757|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
1129758|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
1129759|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
1129760|NCT00488293|E2|Reported Event|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
1129761|NCT00488293|E1|Reported Event|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
1129762|NCT00488059|B1|Baseline|Phase 1: ENF 90mg SC BID|(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
1129763|NCT00488059|P3|Participant Flow|Phase II - Arm B|Phase I then enfuvirtide 180 mg SC QD (2 x 90-mg injections) + RAL 400 mg PO BID + OB (with at least 1 fully active ARV agent excluding NRTIs)
1129764|NCT00488059|P2|Participant Flow|Phase II - Arm A|Phase I then enfuvirtide 90 mg SC BID + RAL 400 mg PO BID + OB (with at least 1 fully active ARV agent excluding NRTIs)
1129765|NCT00488059|P1|Participant Flow|Phase I|(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
1129766|NCT00488059|O3|Outcome|Phase II - Arm B|Phase I then ENF 180 mg SC QD
1129767|NCT00488059|O2|Outcome|Phase II - Arm A|Phase I then ENF 90 mg SC BID
1129813|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129769|NCT00488059|O2|Outcome|Phase II Arm B: Phase I Then ENF 180mg QD|"(Phase 1: ENF 90 mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).~In the randomized comparator phase Phase II of the trial– (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to~(Phase II Arm B: Phase I then ENF 180mg SC QD): ENF 180 mg SC once daily (QD) + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
1129770|NCT00488059|O1|Outcome|Phase II Arm A: Phase I Then ENF 90mg BID|"(Phase 1: ENF 90 mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).~In the randomized comparator phase Phase II of the trial– (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to~(Phase II Arm A: Phase I then ENF 90mg SC BID): ENF 90 mg SC BID + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
1129771|NCT00488059|O2|Outcome|Phase II Arm B: Phase I Then ENF 180mg SC QD|"(Phase 1: ENF 90 mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).~In the randomized comparator phase Phase II of the trial– (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to~(Phase II Arm B: Phase I then ENF 180mg SC QD): ENF 180 mg SC once daily (QD) + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
1129772|NCT00488059|O1|Outcome|Phase II Arm A: Phase I Then ENF 90mg SC BID|"(Phase 1: ENF 90 mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).~In the randomized comparator phase Phase II of the trial– (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to~(Phase II Arm A: Phase I then ENF 90mg SC BID): ENF 90 mg SC BID + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
1129773|NCT00488059|O1|Outcome|Phase I: ENF 90mg SC BID|(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
1129774|NCT00488059|O2|Outcome|Phase II Arm B: Phase I Then ENF 180mg SC QD|"(Phase 1: ENF 90 mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).~In the randomized comparator phase Phase II of the trial– (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to~(Phase II Arm B: Phase I then ENF 180mg SC QD): ENF 180 mg SC once daily (QD) + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
1129775|NCT00488059|O1|Outcome|Phase II Arm A: Phase I Then ENF 90 mg SC BID|"(Phase 1: ENF 90 mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).~In the randomized comparator phase Phase II of the trial– (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to~(Phase II Arm A: Phase I+ENF 90mg SC BID): ENF 90 mg SC BID + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
1129776|NCT00488059|O1|Outcome|Phase I: ENF 90mg SC BID|(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
1129777|NCT00488059|O1|Outcome|Phase I: ENF 90mg SC BID|(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
1129778|NCT00488059|E3|Reported Event|Phase II Arm B: Phase I Then ENF 180mg SC QD|"(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).~In the randomized comparator phase Phase II of the trial– (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized~(Phase II Arm B: Phase I then ENF 180mg SC once daily (QD)): ENF 180 mg SC QD + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
1129779|NCT00488059|E2|Reported Event|Phase II Arm A: Phase I Then ENF 90mg SC BID|"(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).~In the randomized comparator phase Phase II of the trial– (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to~(Phase II Arm A: Phase I then ENF 90mg SC BID): ENF 90 mg SC BID + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
1129782|NCT00488033|B2|Baseline|Coronary Computed Tomographic Angiography|Received medical management recommendations based on the results of their CT scans.
1129783|NCT00488033|B1|Baseline|Standard of Care|Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
1129784|NCT00488033|P2|Participant Flow|Coronary Computed Tomographic Angiography|Received medical management recommendations based on the results of their CT scans.
1129785|NCT00488033|P1|Participant Flow|Standard of Care|Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
1129786|NCT00488033|O2|Outcome|Coronary Computed Tomographic Angiography|Received medical management recommendations based on the results of their CT scans.
1129787|NCT00488033|O1|Outcome|Standard of Care|Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
1129788|NCT00488033|O2|Outcome|Coronary Computed Tomographic Angiography|Received medical management recommendations based on the results of their CT scans.
1129789|NCT00488033|O1|Outcome|Standard of Care|Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
1129790|NCT00488033|O2|Outcome|Coronary Computed Tomographic Angiography|Received medical management recommendations based on the results of their CT scans.
1129791|NCT00488033|O1|Outcome|Standard of Care|Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
1129792|NCT00488033|O2|Outcome|Coronary Computed Tomographic Angiography|Received medical management recommendations based on the results of their CT scans.
1129793|NCT00488033|O1|Outcome|Standard of Care|Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
1129794|NCT00488033|O2|Outcome|Coronary Computed Tomographic Angiography|Received medical management recommendations based on the results of their CT scans.
1129795|NCT00488033|O1|Outcome|Standard of Care|Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
1129796|NCT00488033|O2|Outcome|Coronary Computed Tomographic Angiography|Received medical management recommendations based on the results of their CT scans.
1129797|NCT00488033|O1|Outcome|Standard of Care|Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
1129798|NCT00488033|E2|Reported Event|Coronary Computed Tomographic Angiography|Received medical management recommendations based on the results of their CT scans.
1129799|NCT00488033|E1|Reported Event|Standard of Care|Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care.
1129800|NCT00487981|B1|Baseline|Spinal Cord Stimulation (SCS) Group|Spinal Cord Stimulation (SCS) Treatment Group
1129801|NCT00487981|P1|Participant Flow|Spinal Cord Stimulation (SCS) Group|Spinal Cord Stimulation (SCS) Treatment Group
1129802|NCT00487981|O1|Outcome|Spinal Cord Stimulation (SCS) Group|Spinal Cord Stimulation (SCS) Treatment Group
1129803|NCT00487981|E1|Reported Event|Spinal Cord Stimulation (SCS) Group|Spinal Cord Stimulation (SCS) Treatment Group
1129804|NCT00487942|B5|Baseline|Total|Total of all reporting groups
1129805|NCT00487942|B4|Baseline|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129806|NCT00487942|B3|Baseline|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129807|NCT00487942|B2|Baseline|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129808|NCT00487942|B1|Baseline|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129809|NCT00487942|P4|Participant Flow|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129810|NCT00487942|P3|Participant Flow|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129811|NCT00487942|P2|Participant Flow|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129812|NCT00487942|P1|Participant Flow|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1131110|NCT00485433|P2|Participant Flow|SKY0402 Low Dose|SKY0402 low dose given during hernia repair
1129814|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129815|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129816|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129817|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129818|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129819|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129820|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129821|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129822|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129823|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129824|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129825|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129826|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129827|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129828|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129829|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129830|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129831|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129832|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129833|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129834|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129835|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129836|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129837|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129838|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129839|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129840|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129841|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129842|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129843|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129844|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129845|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129846|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129847|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129848|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129849|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129850|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129851|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129852|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129853|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129854|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129855|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129856|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129857|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129858|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129859|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129860|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129861|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129862|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129863|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129864|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129865|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129866|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129867|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129868|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129869|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129870|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129871|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129872|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129873|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129874|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129875|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129876|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129877|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129878|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129879|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129880|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129881|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129882|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129883|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129884|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129885|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129886|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129887|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129888|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129889|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129890|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129891|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129892|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129893|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129894|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129895|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129896|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129897|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129898|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129899|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129900|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129901|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129902|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129903|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129904|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129905|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129906|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129907|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129908|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129909|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129910|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129911|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129912|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129913|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129914|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129915|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129916|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129917|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129918|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129919|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129920|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129921|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129922|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129923|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129924|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129925|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129926|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129927|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129928|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129929|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129930|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129931|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129932|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129933|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129934|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129935|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129936|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129937|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129938|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129939|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129940|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129941|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129942|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129943|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129944|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129945|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129946|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129947|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129948|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129949|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129950|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129951|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129952|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129953|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129954|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129955|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129956|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129957|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129958|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129959|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129960|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129961|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129962|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129963|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129964|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129965|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129966|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129967|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129968|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129969|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129970|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129971|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129972|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129973|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129974|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129975|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129976|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129977|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129978|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129979|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129980|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129981|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129982|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129983|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129984|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129985|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129986|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129987|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129988|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129989|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129990|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129991|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129992|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129993|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129994|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129995|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1129996|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1129997|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1129998|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1129999|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130000|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130001|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130002|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130003|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130004|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130005|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130006|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130007|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130008|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130009|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130010|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130011|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130012|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130013|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130014|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130015|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130016|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130017|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130018|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130019|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130020|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130021|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130022|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130023|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130024|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130025|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130026|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130027|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130028|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130029|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130030|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130031|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130032|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130033|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130034|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130035|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130036|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130037|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130038|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130039|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130040|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130041|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130042|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130043|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130044|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130045|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130046|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130047|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130048|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130049|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130050|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130051|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130052|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130053|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130054|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130055|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130056|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130057|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130058|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130059|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130060|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130061|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130062|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130063|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130064|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130065|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130066|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130067|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130068|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130069|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130070|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130071|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130072|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130073|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130074|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130075|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130076|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130077|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130078|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130079|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130080|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130081|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130082|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130083|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130084|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130085|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130086|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130087|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130088|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130089|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130090|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130091|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130092|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130093|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130094|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130095|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130096|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130097|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130098|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130099|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130100|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130101|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130102|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130103|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130104|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130105|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130106|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130107|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130108|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130109|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130110|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130111|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130112|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130113|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130114|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130115|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130116|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130117|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130118|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130119|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130120|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130121|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130122|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130123|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130124|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130125|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130126|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130127|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130128|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130129|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130130|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130131|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130132|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130133|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130134|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130135|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130136|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130137|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130138|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130139|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130140|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130141|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130142|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130143|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130144|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130145|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130146|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130147|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130148|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130149|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130150|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130151|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130152|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130153|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130154|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130155|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130156|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130157|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130158|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130159|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130160|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130161|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130162|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130163|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130164|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130165|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130166|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130167|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130168|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130169|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130170|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130171|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130172|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130173|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130174|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130175|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130176|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130177|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130178|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130179|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130180|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130181|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130182|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130183|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130184|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130185|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130186|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130187|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130188|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130189|NCT00487942|E4|Reported Event|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
1130190|NCT00487942|E3|Reported Event|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
1130191|NCT00487942|E2|Reported Event|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
1130192|NCT00487942|E1|Reported Event|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
1130193|NCT00487825|B3|Baseline|Total|Total of all reporting groups
1131111|NCT00485433|P1|Participant Flow|Bupivacaine HCl 105mg|Bupivacaine HCl given during hernia repair
1130194|NCT00487825|B2|Baseline|Methotrexate|Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
1130225|NCT00487695|B1|Baseline|All Study Participants|Patients received both procedures (CLE and standard EGD), so baseline characteristics are reported for the group
1131378|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
1130195|NCT00487825|B1|Baseline|Canakinumab + Methotrexate|Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly.
1130196|NCT00487825|P2|Participant Flow|Methotrexate|Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
1130197|NCT00487825|P1|Participant Flow|Canakinumab + Methotrexate|Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly.
1130198|NCT00487825|O2|Outcome|Methotrexate|Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
1130199|NCT00487825|O1|Outcome|Canakinumab + Methotrexate|Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly.
1130200|NCT00487825|O2|Outcome|Methotrexate|Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
1130201|NCT00487825|O1|Outcome|Canakinumab + Methotrexate|Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly.
1130202|NCT00487825|O2|Outcome|Methotrexate|Methotrexate is given as variable dosing regimen of 7.5 mg-15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
1130203|NCT00487825|O1|Outcome|Canakinumab + Methotrexate|Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. Methotrexate is given as variable dosing regimen of 7.5 mg-15 mg weekly.
1130204|NCT00487825|O2|Outcome|Methotrexate|Methotrexate is given as variable dosing regimen of 7.5 mg-15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
1130205|NCT00487825|O1|Outcome|Canakinumab + Methotrexate|Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. Methotrexate is given as variable dosing regimen of 7.5 mg-15 mg weekly.
1130206|NCT00487825|E2|Reported Event|Methotrexate|Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
1130207|NCT00487825|E1|Reported Event|Canakinumab + Methotrexate|Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly.
1130208|NCT00487747|B1|Baseline|Peginterferon Alfa-2a|Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
1130209|NCT00487747|P1|Participant Flow|Peginterferon Alfa-2a|Eligible participants were administered peginterferon alfa-2a [Pegasys], 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
1130210|NCT00487747|O1|Outcome|Peginterferon Alfa-2a|Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
1130211|NCT00487747|O1|Outcome|Peginterferon Alfa-2a|Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
1130212|NCT00487747|O1|Outcome|Peginterferon Alfa-2a|Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
1130213|NCT00487747|O1|Outcome|Peginterferon Alfa-2a|Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
1130214|NCT00487747|O1|Outcome|Peginterferon Alfa-2a|Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
1130215|NCT00487747|O1|Outcome|Peginterferon Alfa-2a|Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
1130216|NCT00487747|E1|Reported Event|Peginterferon Alfa-2a|Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks.
1130217|NCT00487721|B3|Baseline|Total|Total of all reporting groups
1130218|NCT00487721|B2|Baseline|Control|Subjects in the control arm did not receive any treatment or placebo.
1130219|NCT00487721|B1|Baseline|Silibin-Phytosome|Subjects in this group received silybin-phytosome for 2–10 weeks, depending on the time from enrollment until the time of the prostatectomy. The dose of silybin-phytosome was 13 g daily in three divided doses.
1130220|NCT00487721|P2|Participant Flow|Control|Subjects in the control arm did not receive any treatment or placebo.
1130221|NCT00487721|P1|Participant Flow|Silibin-Phytosome|Subjects in this group received silybin-phytosome for 2–10 weeks, depending on the time from enrollment until the time of the prostatectomy. The dose of silybin-phytosome was 13 g daily in three divided doses.
1130222|NCT00487721|O1|Outcome|Silibin-Phytosome|Subjects in this group received silybin-phytosome for 2–10 weeks, depending on the time from enrollment until the time of the prostatectomy. The dose of silybin-phytosome was 13 g daily in three divided doses.
1130223|NCT00487721|E2|Reported Event|Control|Subjects in the control arm did not receive any treatment or placebo.
1131345|NCT00484419|P3|Participant Flow|Sitagliptin|sitagliptin phosphate tablets 100mg
1130224|NCT00487721|E1|Reported Event|Silibin-Phytosome|Subjects in this group received silybin-phytosome for 2–10 weeks, depending on the time from enrollment until the time of the prostatectomy. The dose of silybin-phytosome was 13 g daily in three divided doses.
1130226|NCT00487695|P2|Participant Flow|Standard EGD Followed by CLE|Patients in this group were randomized to have standard EGD followed by CLE 6 weeks later
1130227|NCT00487695|P1|Participant Flow|CLE Followed by Standard EGD|Patients randomized to either CLE or standard endoscopy first. The other procedure was then performed 6 weeks later. This group was randomized to CLE first, followed by standard endoscopy
1130228|NCT00487695|O2|Outcome|Standard Endoscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
1130229|NCT00487695|O1|Outcome|Confocal Laser Endomicroscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
1130230|NCT00487695|O2|Outcome|Standard Endoscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
1130231|NCT00487695|O1|Outcome|Confocal Laser Endomicroscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
1130232|NCT00487695|O2|Outcome|Standard Endoscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
1130233|NCT00487695|O1|Outcome|Confocal Laser Endomicroscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
1130234|NCT00487695|O2|Outcome|Standard Endoscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
1130235|NCT00487695|O1|Outcome|Confocal Laser Endomicroscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
1130236|NCT00487695|O2|Outcome|Standard Endoscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
1130237|NCT00487695|O1|Outcome|Confocal Laser Endomicroscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
1130238|NCT00487695|O2|Outcome|Standard Endoscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
1130239|NCT00487695|O1|Outcome|Confocal Laser Endomicroscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
1130240|NCT00487695|E2|Reported Event|Standard EGD|Adverse even reporting is being done by procedure type (ie confocal laser endomicroscopy vs. standard endoscopy)
1130241|NCT00487695|E1|Reported Event|Confocal Laser Endomicroscopy|Adverse even reporting is being done by procedure type (ie confocal laser endomicroscopy vs. standard endoscopy)
1130242|NCT00487669|B1|Baseline|Paclitaxel Poliglumex With Pemetrexed|The first 6 eligible patients will be enrolled at a dose of 135 mg/m2 paclitaxel poliglumex in combination with 500 mg/m2 of pemetrexed. Patients who experience disease progression without dose-limiting adverse events after the initial cycle will be replaced. Dose escalation to the next dose level can occur provided that no more than 1 of 6 patients experience in initial dose limiting toxicity (IDLT) following 2 cycles of therapy. If ≥ 2 of 6 patients experience IDLTs at the 135 mg/m2 dose, the maximally tolerated dose (MTD) was surpassed and the study will be discontinued.
1130243|NCT00487669|P1|Participant Flow|Paclitaxel Poliglumex With Pemetrexed|The first 6 eligible patients will be enrolled at a dose of 135 mg/m2 paclitaxel poliglumex in combination with 500 mg/m2 of pemetrexed. Patients who experience disease progression without dose-limiting adverse events after the initial cycle will be replaced. Dose escalation to the next dose level can occur provided that no more than 1 of 6 patients experience in initial dose limiting toxicity (IDLT) following 2 cycles of therapy. If ≥ 2 of 6 patients experience IDLTs at the 135 mg/m2 dose, the maximally tolerated dose (MTD) was surpassed and the study will be discontinued.
1130244|NCT00487669|O2|Outcome|Level 2|Dose escalation to the next dose level, paclitaxel poliglumex at 175 mg/m2 and pemetrexed at 500 mg/m2, occurred when no more than 1 of 6 patients experience initial dose limiting toxicity (IDLT) following 2 cycles of therapy on the first dose level. If ≥ 2 of 6 patients experience IDLTs, the maximally tolerated dose (MTD) would have been surpassed and the study stopped.
1130245|NCT00487669|O1|Outcome|Level 1|The first 6 eligible patients were enrolled at a dose of 135 mg/m2 of paclitaxel poliglumex administered intravenously over 10-20 minutes followed by 500 mg/m2 of pemetrexed administered intravenously over 10 minutes every 3 weeks.
1130246|NCT00487669|O2|Outcome|Level 2|Dose escalation to the next dose level, paclitaxel poliglumex at 175 mg/m2 and pemetrexed at 500 mg/m2, occurred when no more than 1 of 6 patients experience initial dose limiting toxicity (IDLT) following 2 cycles of therapy on the first dose level. If ≥ 2 of 6 patients experience IDLTs, the maximally tolerated dose (MTD) would have been surpassed and the study stopped.
1130247|NCT00487669|O1|Outcome|Level 1|The first 6 eligible patients were enrolled at a dose of 135 mg/m2 of paclitaxel poliglumex administered intravenously over 10-20 minutes followed by 500 mg/m2 of pemetrexed administered intravenously over 10 minutes every 3 weeks.
1130248|NCT00487669|O2|Outcome|Level 2|Dose escalation to the next dose level, paclitaxel poliglumex at 175 mg/m2 and pemetrexed at 500 mg/m2, occurred when no more than 1 of 6 patients experience initial dose limiting toxicity (IDLT) following 2 cycles of therapy on the first dose level. If ≥ 2 of 6 patients experience IDLTs, the maximally tolerated dose (MTD) would have been surpassed and the study stopped.
1130249|NCT00487669|O1|Outcome|Level 1|The first 6 eligible patients were enrolled at a dose of 135 mg/m2 of paclitaxel poliglumex administered intravenously over 10-20 minutes followed by 500 mg/m2 of pemetrexed administered intravenously over 10 minutes every 3 weeks.
1130292|NCT00487539|O3|Outcome|Golimumab 400 mg -> 200 mg|Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
1130250|NCT00487669|E2|Reported Event|Level 2|Dose escalation to the next dose level, paclitaxel poliglumex at 175 mg/m2 and pemetrexed at 500 mg/m2, occurred when no more than 1 of 6 patients experience initial dose limiting toxicity (IDLT) following 2 cycles of therapy on the first dose level. If ≥ 2 of 6 patients experience IDLTs, the maximally tolerated dose (MTD) would have been surpassed and the study stopped.
1130251|NCT00487669|E1|Reported Event|Level 1|The first 6 eligible patients were enrolled at a dose of 135 mg/m2 of paclitaxel poliglumex administered intravenously over 10-20 minutes followed by 500 mg/m2 of pemetrexed administered intravenously over 10 minutes every 3 weeks.
1130252|NCT00487578|B3|Baseline|Total|Total of all reporting groups
1130253|NCT00487578|B2|Baseline|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
1130254|NCT00487578|B1|Baseline|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
1130255|NCT00487578|P2|Participant Flow|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
1130256|NCT00487578|P1|Participant Flow|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
1130257|NCT00487578|O2|Outcome|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
1130258|NCT00487578|O1|Outcome|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
1130259|NCT00487578|O2|Outcome|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
1130260|NCT00487578|O1|Outcome|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
1130261|NCT00487578|O2|Outcome|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
1130262|NCT00487578|O1|Outcome|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
1130263|NCT00487578|O2|Outcome|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
1130264|NCT00487578|O1|Outcome|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
1130265|NCT00487578|O2|Outcome|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
1130266|NCT00487578|O1|Outcome|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
1130267|NCT00487578|O2|Outcome|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
1130268|NCT00487578|O1|Outcome|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
1130269|NCT00487578|E2|Reported Event|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
1130270|NCT00487578|E1|Reported Event|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
1130271|NCT00487565|B1|Baseline|LCS Complete Posterior Stabilized Knee Implant|Total knee arthroplasty with a posterior stabilized implant
1130272|NCT00487565|P1|Participant Flow|LCS Complete Posterior Stabilized Knee Implant|Total knee arthroplasty with a posterior stabilized implant
1130273|NCT00487565|O1|Outcome|LCS Complete Posterior Stabilized Knee Implant|Total knee arthroplasty with a posterior stabilized implant
1130274|NCT00487565|E1|Reported Event|LCS Complete Posterior Stabilized Knee Implant|Total knee arthroplasty with a posterior stabilized implant
1130275|NCT00487552|B1|Baseline|Magnetic Anastomosis Device (MAD) With Stent|Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction.
1130276|NCT00487552|P1|Participant Flow|Magnetic Anastomosis Device (MAD) With Stent|Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction.
1130277|NCT00487552|O1|Outcome|Magnetic Anastomosis Device (MAD)|Magnetic Anastomosis Device (MAD) used for palliative treatment of gastric outlet obstruction.
1130278|NCT00487552|O1|Outcome|Magnetic Anastomosis Device (MAD) With Stent|Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction.
1130279|NCT00487552|E1|Reported Event|Magnetic Anastomosis Device (MAD) With Stent|Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction.
1130280|NCT00487539|B5|Baseline|Total|Total of all reporting groups
1130281|NCT00487539|B4|Baseline|Golimumab 400 mg -> 200 mg|Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
1130282|NCT00487539|B3|Baseline|Golimumab 200 mg -> 100 mg|Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.
1130283|NCT00487539|B2|Baseline|Golimumab 100 mg -> 50 mg|Golimumab 100 milligram (mg) subcutaneous injection was administered at Week 0 and dose was decreased to 50 mg at Week 2.
1130284|NCT00487539|B1|Baseline|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.
1130285|NCT00487539|P4|Participant Flow|Golimumab 400 mg -> 200 mg|Golimumab 400 mg subcutaneous injection was administered at Week 0 and the dose was decreased to 200 mg at Week 2. This dosing regimen was selected for the efficacy analysis (only in newly enrolled participants following dose-selection, as per planned analysis).
1130286|NCT00487539|P3|Participant Flow|Golimumab 200 mg -> 100 mg|Golimumab 200 mg subcutaneous injection was administered at Week 0 and the dose was decreased to 100 mg at Week 2. This dosing regimen was selected for the efficacy analysis (only in newly enrolled participants following dose-selection, as per planned analysis).
1130287|NCT00487539|P2|Participant Flow|Golimumab 100 mg -> 50 mg|Golimumab 100 milligram (mg) subcutaneous injection was administered at Week 0 and dose was decreased to 50 mg at Week 2.
1130288|NCT00487539|P1|Participant Flow|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2. This dosing regimen was selected for the efficacy analysis (only in newly enrolled participants following dose-selection, as per planned analysis).
1130289|NCT00487539|O3|Outcome|Golimumab 400 mg -> 200 mg|Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
1130290|NCT00487539|O2|Outcome|Golimumab 200 mg -> 100 mg|Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.
1130291|NCT00487539|O1|Outcome|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.
1130343|NCT00487240|B3|Baseline|Total|Total of all reporting groups
1130293|NCT00487539|O2|Outcome|Golimumab 200 mg -> 100 mg|Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.
1130294|NCT00487539|O1|Outcome|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.
1131379|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
1130295|NCT00487539|O3|Outcome|Golimumab 400 mg -> 200 mg|Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
1130296|NCT00487539|O2|Outcome|Golimumab 200 mg -> 100 mg|Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.
1130297|NCT00487539|O1|Outcome|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.
1130298|NCT00487539|O3|Outcome|Golimumab 400 mg -> 200 mg|Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
1130299|NCT00487539|O2|Outcome|Golimumab 200 mg -> 100 mg|Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.
1130300|NCT00487539|O1|Outcome|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.
1130301|NCT00487539|E4|Reported Event|Golimumab 400 mg -> 200 mg|Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
1130302|NCT00487539|E3|Reported Event|Golimumab 200 mg -> 100 mg|Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.
1130303|NCT00487539|E2|Reported Event|Golimumab 100 mg -> 50 mg|Golimumab 100 milligram (mg) subcutaneous injection was administered at Week 0 and dose was decreased to 50 mg at Week 2.
1130304|NCT00487539|E1|Reported Event|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.
1130305|NCT00487461|B4|Baseline|Total|Total of all reporting groups
1130306|NCT00487461|B3|Baseline|Study Group #2|"Simvastatin 80 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
1130307|NCT00487461|B2|Baseline|Study Group #1|"Simvastatin 40 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
1130308|NCT00487461|B1|Baseline|Control Group|"Placebo tablet~Placebo: Placebo tablet"
1130309|NCT00487461|P3|Participant Flow|Study Group #2|"Simvastatin 80 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
1130310|NCT00487461|P2|Participant Flow|Study Group #1|"Simvastatin 40 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
1130311|NCT00487461|P1|Participant Flow|Control Group|"Placebo tablet~Placebo: Placebo tablet"
1130312|NCT00487461|O3|Outcome|Study Group #2|"Simvastatin 80 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
1130313|NCT00487461|O2|Outcome|Study Group #1|"Simvastatin 40 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
1130314|NCT00487461|O1|Outcome|Control Group|"Placebo tablet~Placebo: Placebo tablet"
1130315|NCT00487461|O3|Outcome|Study Group #2|"Simvastatin 80 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
1130316|NCT00487461|O2|Outcome|Study Group #1|"Simvastatin 40 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
1130317|NCT00487461|O1|Outcome|Control Group|"Placebo tablet~Placebo: Placebo tablet"
1130318|NCT00487461|E3|Reported Event|Study Group #2|"Simvastatin 80 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
1130319|NCT00487461|E2|Reported Event|Study Group #1|"Simvastatin 40 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
1130320|NCT00487461|E1|Reported Event|Control Group|"Placebo tablet~Placebo: Placebo tablet"
1130321|NCT00487435|B1|Baseline|Tapentadol (CG5503) Extended Release (ER)|Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year
1130322|NCT00487435|P1|Participant Flow|Tapentadol (CG5503) Extended Release (ER)|Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year
1130323|NCT00487435|O1|Outcome|Tapentadol (CG5503) Extended Release (ER)|Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year
1130324|NCT00487435|O1|Outcome|Tapentadol (CG5503) Extended Release (ER)|Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year
1130325|NCT00487435|E1|Reported Event|Tapentadol (CG5503) Extended Release (ER)|Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year
1130326|NCT00487396|B1|Baseline|SB Capsule Then Standard Ileocolonoscopy|Capsule endoscopy was ingested .The purpose was to detect patients with crohn Patients subsequently had standard ileocolonoscopy and small bowel follow through as comparison.
1130327|NCT00487396|P1|Participant Flow|SB Capsule Then Standard Ileocolonoscopy|Capsule endoscopy was ingested .The purpose was to detect patients with crohn Patients subsequently had standard ileocolonoscopy and small bowel follow through as comparison.
1130328|NCT00487396|O2|Outcome|Small Bowel Follow Through(SBFT) Followed by Ileo-colonoscopy|Patients subsequently had SBFT followed by ileo-colonoscopy .
1130329|NCT00487396|O1|Outcome|PillCam SB Followed by Ileo Colonoscopy|Ingestible capsule equipped with an endoscope with one imagers, before ileo-colonoscopy.
1130330|NCT00487396|E2|Reported Event|Adverse Events Related to Capsule|AE related to the capsule endoscopy procedure
1130331|NCT00487396|E1|Reported Event|Adverse Events Related to Ileocolonoscopy|AE related to the ileocolonoscopy procedure
1130332|NCT00487279|B3|Baseline|Total|Total of all reporting groups
1130333|NCT00487279|B2|Baseline|Control Group|Medical therapy alone
1130334|NCT00487279|B1|Baseline|ICD Group|ICD (Implantable Cardioverter Defibrillator)in combination with medical therapy
1130335|NCT00487279|P2|Participant Flow|Control Group|Medical therapy alone
1130336|NCT00487279|P1|Participant Flow|ICD Group|ICD (Implantable Cardioverter Defibrillator)in combination with medical therapy
1130337|NCT00487279|O2|Outcome|Control Group|Medical therapy alone
1130338|NCT00487279|O1|Outcome|ICD Group|ICD (Implantable Cardioverter Defibrillator)in combination with medical therapy
1130339|NCT00487279|O2|Outcome|Control Group|Medical therapy alone
1130340|NCT00487279|O1|Outcome|ICD Group|ICD (Implantable Cardioverter Defibrillator)in combination with medical therapy
1130341|NCT00487279|E2|Reported Event|Control Group|Medical therapy alone
1130342|NCT00487279|E1|Reported Event|ICD Group|ICD (Implantable Cardioverter Defibrillator)in combination with medical therapy
1130344|NCT00487240|B2|Baseline|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
1130701|NCT00486720|O2|Outcome|Vorinostat Thrice Daily Dose Schedule|Vorinostat 200 mg three times daily for 14 consecutive days in a 21 day cycle.
1130345|NCT00487240|B1|Baseline|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
1130346|NCT00487240|P2|Participant Flow|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
1130347|NCT00487240|P1|Participant Flow|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
1130348|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
1130349|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
1130350|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
1130351|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
1130352|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
1130353|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
1130354|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
1130355|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
1130356|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
1130357|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
1130358|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
1130359|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
1130360|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
1130361|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
1130362|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
1130363|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
1130364|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
1130365|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
1130366|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
1130367|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
1130368|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
1130369|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
1130370|NCT00487240|E2|Reported Event|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
1130371|NCT00487240|E1|Reported Event|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
1130372|NCT00487188|B3|Baseline|Total|Total of all reporting groups
1130373|NCT00487188|B2|Baseline|HAART|Participants received highly active antiretroviral treatment.
1130374|NCT00487188|B1|Baseline|ENF+HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
1130375|NCT00487188|P3|Participant Flow|HAART (ENF Removed)|Participants who had received ENF + HAART during the Induction Phase and responded to treatment by Week 24 continued to receive HAART alone during the Maintenance Phase, for a total of 48 weeks of treatment.
1130376|NCT00487188|P2|Participant Flow|HAART|Participants received highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
1130377|NCT00487188|P1|Participant Flow|ENF + HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
1130378|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment.
1130379|NCT00487188|O1|Outcome|ENF+HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
1130380|NCT00487188|O3|Outcome|HAART (ENF Removed)|Participants who had received ENF + HAART during the Induction Phase and responded to treatment by Week 24 continued to receive HAART alone during the Maintenance Phase, for a total of 48 weeks of treatment.
1130381|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
1130382|NCT00487188|O1|Outcome|ENF + HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
1130702|NCT00486720|O1|Outcome|Vorinostat Once Daily Dose Schedule|Vorinostat 400 mg once daily for 14 consecutive days in a 21 day cycle.
1130383|NCT00487188|O3|Outcome|HAART (ENF Removed)|Participants who had received ENF + HAART during the Induction Phase and responded to treatment by Week 24 continued to receive HAART alone during the Maintenance Phase, for a total of 48 weeks of treatment.
1130384|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
1130385|NCT00487188|O1|Outcome|ENF + HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
1130386|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment during both the Induction and Maintenance Phase.
1130387|NCT00487188|O1|Outcome|ENF+HAART|"Participants received enfuvirtide (ENF) 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment (HAART) in the Induction Phase. In the Maintenance Phase, participants either continued to receive ENF+HAART or HAART alone.~This group contains all patients who entered the Maintenance Phase from the ENF+HAART Induction Phase, regardless of which arm they were randomized to at BL2."
1130388|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment during both the Induction and Maintenance Phase.
1130389|NCT00487188|O1|Outcome|ENF+HAART|"Participants received enfuvirtide (ENF) 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment (HAART) in the Induction Phase. In the Maintenance Phase, participants either continued to receive ENF+HAART or HAART alone.~This group contains all patients who entered the Maintenance Phase from the ENF+HAART Induction Phase, regardless of which arm they were randomized to at BL2."
1130390|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment during both the Induction and Maintenance Phase.
1130391|NCT00487188|O1|Outcome|ENF+HAART|"Participants received enfuvirtide (ENF) 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment (HAART) in the Induction Phase. In the Maintenance Phase, participants either continued to receive ENF+HAART or HAART alone.~This group contains all patients who entered the Maintenance phase from the ENF+HAART Induction phase, regardless of which arm they were randomized to at BL2."
1130392|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment during both the Induction and Maintenance Phase.
1130393|NCT00487188|O1|Outcome|ENF+HAART|"Participants received enfuvirtide (ENF) 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment (HAART) in the Induction Phase. In the Maintenance Phase, participants either continued to receive ENF+HAART or HAART alone.~This group contains all patients who entered the Maintenance phase from the ENF+HAART Induction phase, regardless of which arm they were randomized to at BL2."
1130394|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment during both the Induction and Maintenance Phase.
1130395|NCT00487188|O1|Outcome|ENF+HAART|"Participants received enfuvirtide (ENF) 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment (HAART) in the Induction Phase. In the Maintenance Phase, participants either continued to receive ENF+HAART or HAART alone.~This group contains all patients who entered the Maintenance phase from the ENF+HAART Induction phase, regardless of which arm they were randomized to at BL2."
1130396|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment during both the Induction and Maintenance Phase.
1130397|NCT00487188|O1|Outcome|ENF+HAART|"Participants received enfuvirtide (ENF) 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment (HAART) in the Induction Phase. In the Maintenance Phase, participants either continued to receive ENF+HAART or HAART alone.~This group contains all patients who were randomized to ENF+HAART at BL1 and follows the patients throughout 48 weeks, regardless of which arm they were randomized to at BL2."
1130398|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment.
1130399|NCT00487188|O1|Outcome|ENF+HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
1130400|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment.
1130401|NCT00487188|O1|Outcome|ENF+HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
1130402|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment.
1130403|NCT00487188|O1|Outcome|ENF+HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
1130404|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment.
1130405|NCT00487188|O1|Outcome|ENF+HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
1130406|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment.
1130407|NCT00487188|O1|Outcome|ENF+HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
1130408|NCT00487188|E5|Reported Event|Maintenance Phase: HAART|During the Maintenance Phase, participants who had received HAART alone and who responded to treatment during the Induction Phase continued to receive highly active antiretroviral treatment for up to 48 weeks of total treatment.
1130409|NCT00487188|E4|Reported Event|Maintenance Phase: HAART (ENF Removed)|During the Maintenance Phase, participants who had received ENF+HAART and who responded to treatment during the Induction Phase continued to receive HAART alone during the Maintenance Phase, for up to a total of 48 weeks treatment.
1130410|NCT00487188|E3|Reported Event|Maintenance Phase: ENF + HAART|During the Maintenance Phase, participants who had received ENF+HAART and who responded to treatment during the Induction Phase continued to receive enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment for up to 48 weeks of total treatment.
1130411|NCT00487188|E2|Reported Event|Induction Phase: HAART|During the Induction Phase participants received highly active antiretroviral treatment for a maximum of 32 weeks.
1130412|NCT00487188|E1|Reported Event|Induction: ENF+HAART|During the Induction Phase participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment for a maximum of 32 weeks.
1130413|NCT00487162|B3|Baseline|Total|Total of all reporting groups
1131346|NCT00484419|P2|Participant Flow|Rosiglitazone|rosiglitazone maleate 4mg
1130414|NCT00487162|B2|Baseline|Intensive Glycemic Control|In this treatment group, continuous insulin infusion (50 IU of Novolin R [Novo Nordisk]) in 50mL of 0.9% saline via infusion pump will be started when the blood glucose level exceeds 110 mg/dL and will be adjusted to maintain the blood glucose level between 80 and 110 mg/dL.
1130415|NCT00487162|B1|Baseline|Conventional Glycemic Control|Subjects randomized to this study arm had their glucose levels monitored hourly and if the result was greater than 200 mg/dL their anesthesia care provider was notified. The subject was treated as to their care provider discretion.
1130416|NCT00487162|P2|Participant Flow|Intensive Glycemic Control|In the intensive treatment group, continuous insulin infusion (50 IU of Novolin R [Novo Nordisk]) in 50ml of 0.9% saline via infusion pump will be started when the blood glucose level exceeds 110 mg / dL on two consecutive samples and will be adjusted to maintain the blood glucose level between 80 and 110 mg / dL. Adjustments will be made according to the University Hospital's ICU Adult Insulin Infusion Protocol - modified 10/1/07 (Appendix A). When the blood glucose level falls below 80 mg / dL, the insulin infusion will be tapered and discontinued. For patients going to the ICU after surgery, insulin infusions will be continued according to the University Hospital's ICU Adult Insulin Infusion Protocol under the direction of the ICU staff. For patients not being to the ICU after surgery, insulin infusions will be tapered to off after the final hourly blood glucose determination at three hours after the completion of surgery.
1130417|NCT00487162|P1|Participant Flow|Conventional Glycemic Control|Subjects randomized to this study arm had their glucose levels monitored hourly and if the result was greater than 200mg/dL their anesthesia care provider was notified. The subject was treated as to thie care provider discretion.
1130418|NCT00487162|O2|Outcome|Conventional Glycemic Control|conventional glycemic control: Novo regular insulin administered when glucose level exceeded 200 mg/dl and titrated to maintain level between 180-200 mg/dl
1130419|NCT00487162|O1|Outcome|Strict Glycemic Control|strict glycemic control: intravenous insulin titrated every 30 minutes to serum glycemic level of 80-100mg/dl
1130420|NCT00487162|O2|Outcome|Conventional Glycemic Control|conventional glycemic control: Novo regular insulin administered when glucose level exceeded 200 mg/dl and titrated to maintain level between 180-200 mg/dl
1130421|NCT00487162|O1|Outcome|Strict Glycemic Control|strict glycemic control: intravenous insulin titrated every 30 minutes to serum glycemic level of 80-100mg/dl
1130422|NCT00487162|E2|Reported Event|Intensive Glycemic Control|Subjects randomized to this group had glucose levels monitored hourly and when >110mg/dL an insulin drip was initiated to maintain glucose levels between 80-110
1130423|NCT00487162|E1|Reported Event|Conventional Glycemic Control|Subjects randomized to this study arm had their glucose levels monitored hourly and if the result was greater than 200mg/dL their anesthesia care provider was notified. The subject was treated as to their care provider discretion.
1130424|NCT00487084|B4|Baseline|Total|Total of all reporting groups
1130425|NCT00487084|B3|Baseline|Saline - Lidocaine - Morphine (SLM)|Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
1130426|NCT00487084|B2|Baseline|Saline-2 Chloroprocaine - Morphine (SCM)|saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
1130427|NCT00487084|B1|Baseline|Morphine - 2 Chloroprocaine - Saline (MCS)|morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
1130428|NCT00487084|P3|Participant Flow|Saline - Lidocaine - Morphine (SLM)|Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
1130429|NCT00487084|P2|Participant Flow|Saline-2 Chloroprocaine - Morphine (SCM)|saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
1130430|NCT00487084|P1|Participant Flow|Morphine - 2 Chloroprocaine - Saline (MCS)|morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
1130431|NCT00487084|O3|Outcome|Saline - Lidocaine - Morphine (SLM)|Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
1130432|NCT00487084|O2|Outcome|Saline-2 Chloroprocaine - Morphine (SCM)|saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
1130433|NCT00487084|O1|Outcome|Morphine - 2 Chloroprocaine - Saline (MCS)|morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
1130434|NCT00487084|O3|Outcome|Saline - Lidocaine - Morphine (SLM)|Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
1130435|NCT00487084|O2|Outcome|Saline-2 Chloroprocaine - Morphine (SCM)|saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
1130436|NCT00487084|O1|Outcome|Morphine - 2 Chloroprocaine - Saline (MCS)|morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
1130437|NCT00487084|O3|Outcome|Saline - Lidocaine - Morphine (SLM)|Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
1130438|NCT00487084|O2|Outcome|Saline-2 Chloroprocaine - Morphine (SCM)|saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
1130439|NCT00487084|O1|Outcome|Morphine - 2 Chloroprocaine - Saline (MCS)|morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
1130440|NCT00487084|O3|Outcome|Saline - Lidocaine - Morphine (SLM)|Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
1130441|NCT00487084|O2|Outcome|Saline-2 Chloroprocaine - Morphine (SCM)|saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
1130442|NCT00487084|O1|Outcome|Morphine - 2 Chloroprocaine - Saline (MCS)|morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
1130443|NCT00487084|E3|Reported Event|Saline - Lidocaine - Morphine (SLM)|Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
1130444|NCT00487084|E2|Reported Event|Saline-2 Chloroprocaine - Morphine (SCM)|saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
1130445|NCT00487084|E1|Reported Event|Morphine - 2 Chloroprocaine - Saline (MCS)|morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
1130446|NCT00486954|B5|Baseline|Total|Total of all reporting groups
1130447|NCT00486954|B4|Baseline|Paclitaxel Alone in Randomized Part|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130448|NCT00486954|B3|Baseline|Lapatinib Plus Paclitaxel in Randomized Part|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130449|NCT00486954|B2|Baseline|Lapatinib Plus Paclitaxel in Gastrectomy Participants|In the Pilot part, participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
1130450|NCT00486954|B1|Baseline|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|In the Pilot part, participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
1130451|NCT00486954|P5|Participant Flow|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130452|NCT00486954|P4|Participant Flow|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130453|NCT00486954|P3|Participant Flow|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
1130454|NCT00486954|P2|Participant Flow|Lapatinib Plus Paclitaxel in Partial Gastrectomy Participants|Participants with partial gastrectomy (which includes preservation of the pylorus) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2. Partial gastrectomy (pylorus preserved) is very rare population in Japan. As a result, no such participants were recruited into this cohort.
1130455|NCT00486954|P1|Participant Flow|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
1130456|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130457|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130458|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130459|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130460|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130461|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130462|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130463|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130464|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130465|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130466|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130467|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130468|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1140871|NCT00460239|O8|Outcome|Buprenorphine 60 mg|
1130469|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130470|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130471|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130472|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130473|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130474|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130475|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130476|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130477|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130478|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130479|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130480|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130481|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130482|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130483|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130484|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130485|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130486|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130487|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130488|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130489|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130490|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130491|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130492|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130493|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130494|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130495|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130496|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130584|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
1140872|NCT00460239|O7|Outcome|Buprenorphine 48 mg|
1130497|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130498|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130499|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130500|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130501|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130502|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130503|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130504|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130505|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130506|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130507|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130508|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130509|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130510|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130511|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130512|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130513|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130514|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130515|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130516|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130517|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130518|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130519|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130520|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130521|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130522|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
1130523|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
1130585|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
1130524|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
1130525|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
1130526|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
1130527|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
1130528|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
1130529|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
1130530|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
1130531|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
1130532|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
1130533|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
1130534|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
1130535|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
1130536|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
1130537|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
1130538|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
1130539|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
1130540|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
1130541|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
1130542|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130543|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130544|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
1130545|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
1130546|NCT00486954|E4|Reported Event|Paclitaxel Alone in Randomized Part|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130547|NCT00486954|E3|Reported Event|Lapatinib Plus Paclitaxel in Randomized Part|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
1130548|NCT00486954|E2|Reported Event|Lapatinib Plus Paclitaxel in Gastrectomy Participants|In the Pilot part, participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
1130549|NCT00486954|E1|Reported Event|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|In the Pilot part, participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
1130550|NCT00486902|B3|Baseline|Total|Total of all reporting groups
1130551|NCT00486902|B2|Baseline|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
1130552|NCT00486902|B1|Baseline|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
1130553|NCT00486902|P2|Participant Flow|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
1130554|NCT00486902|P1|Participant Flow|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
1130555|NCT00486902|O2|Outcome|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
1130556|NCT00486902|O1|Outcome|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
1130557|NCT00486902|O2|Outcome|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
1130558|NCT00486902|O1|Outcome|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
1130559|NCT00486902|O2|Outcome|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
1130560|NCT00486902|O1|Outcome|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
1130561|NCT00486902|O2|Outcome|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
1130562|NCT00486902|O1|Outcome|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
1130563|NCT00486902|O2|Outcome|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
1130564|NCT00486902|O1|Outcome|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
1130565|NCT00486902|O2|Outcome|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
1130566|NCT00486902|O1|Outcome|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
1130567|NCT00486902|O2|Outcome|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
1130568|NCT00486902|O1|Outcome|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
1130569|NCT00486902|O2|Outcome|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
1130570|NCT00486902|O1|Outcome|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
1130571|NCT00486902|E2|Reported Event|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
1130572|NCT00486902|E1|Reported Event|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
1130573|NCT00486863|B3|Baseline|Total|Total of all reporting groups
1130574|NCT00486863|B2|Baseline|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
1130575|NCT00486863|B1|Baseline|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
1130576|NCT00486863|P2|Participant Flow|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours. The agent was gel encapsulated to reduce appreciation of odor and taste and mimic appearance of the placebo.
1130577|NCT00486863|P1|Participant Flow|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules as the test agent, but with the inert compound dextrose.
1130578|NCT00486863|O1|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
1130579|NCT00486863|O1|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
1130580|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
1130581|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
1130582|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
1130583|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
1140873|NCT00460239|O6|Outcome|Buprenorphine 32 mg|
1130586|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
1130587|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
1130588|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
1130589|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
1130590|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
1130591|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
1130592|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
1130593|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
1130594|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
1130595|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
1130596|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
1130597|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
1130598|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
1130599|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
1130600|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
1130601|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
1130602|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
1130603|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
1130604|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
1130605|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
1130606|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
1130607|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
1130608|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
1130609|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
1130610|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
1130611|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
1130612|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
1130613|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
1130614|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
1130615|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
1130616|NCT00486863|E2|Reported Event|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
1130617|NCT00486863|E1|Reported Event|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
1130618|NCT00486837|B3|Baseline|Total|Total of all reporting groups
1130619|NCT00486837|B2|Baseline|Bronchial Deposition|Bronchial Deposition consists of inhalation of smaller volumes per breath at higher flow rates
1130620|NCT00486837|B1|Baseline|Peripheral Deposition|Peripheral Deposition is achieved with a breathing maneuver consisting of slow and deep breaths
1130621|NCT00486837|P2|Participant Flow|Bronchial Deposition|Bronchial Deposition consists of inhalation of smaller volumes per breath at higher flow rates
1130622|NCT00486837|P1|Participant Flow|Peripheral Deposition|Peripheral Deposition is achieved with a breathing maneuver consisting of slow and deep breaths
1130623|NCT00486837|O2|Outcome|Group 2|"Peripheral Deposition~Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
1130624|NCT00486837|O1|Outcome|Group 1|"Bronchial Deposition~Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
1130625|NCT00486837|O2|Outcome|Group 2|"Peripheral Deposition~Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
1130626|NCT00486837|O1|Outcome|Group 1|"Bronchial Deposition~Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
1130627|NCT00486837|O2|Outcome|Group 2|"Peripheral Deposition~Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
1130628|NCT00486837|O1|Outcome|Group 1|"Bronchial Deposition~Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
1130629|NCT00486837|O2|Outcome|Group 2|"Peripheral Deposition~Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
1130630|NCT00486837|O1|Outcome|Group 1|"Bronchial Deposition~Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
1130631|NCT00486837|O2|Outcome|Group 2|"Peripheral Deposition~Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
1130632|NCT00486837|O1|Outcome|Group 1|"Bronchial Deposition~Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
1130633|NCT00486837|O2|Outcome|Bronchial Deposition|Bronchial Deposition consists of inhalation of smaller volumes per breath at higher flow rates
1130634|NCT00486837|O1|Outcome|Peripheral Deposition|Peripheral Deposition is achieved with a breathing maneuver consisting of slow and deep breaths
1130635|NCT00486837|E2|Reported Event|Bronchial Deposition|Bronchial Deposition consists of inhalation of smaller volumes per breath at higher flow rates
1130636|NCT00486837|E1|Reported Event|Peripheral Deposition|Peripheral Deposition is achieved with a breathing maneuver consisting of slow and deep breaths
1130637|NCT00486811|B4|Baseline|Total|Total of all reporting groups
1130638|NCT00486811|B3|Baseline|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
1130639|NCT00486811|B2|Baseline|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
1130640|NCT00486811|B1|Baseline|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
1130641|NCT00486811|P3|Participant Flow|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
1130642|NCT00486811|P2|Participant Flow|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily) The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
1130643|NCT00486811|P1|Participant Flow|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
1130644|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
1130645|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
1130646|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
1130647|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
1130698|NCT00486720|B1|Baseline|Vorinostat Once Daily Dose Schedule|Vorinostat 400 mg once daily for 14 consecutive days in a 21 day cycle.
1131347|NCT00484419|P1|Participant Flow|Colesevelam|colesevelam tablets 625 mg
1130648|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
1130649|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
1130650|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
1130651|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
1130652|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
1130653|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
1130654|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
1130655|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
1130656|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
1130657|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
1130658|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
1130659|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
1130660|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
1130661|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
1130699|NCT00486720|P2|Participant Flow|Vorinostat Thrice Daily Dose Schedule|Vorinostat 200 mg three times daily for 14 consecutive days in a 21 day cycle.
1131348|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
1130662|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
1130663|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
1130664|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
1130665|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
1130666|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
1130667|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
1130668|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
1130669|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
1130670|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
1130671|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
1130672|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
1130673|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
1130674|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
1130675|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
1130700|NCT00486720|P1|Participant Flow|Vorinostat Once Daily Dose Schedule|Vorinostat 400 mg once daily for 14 consecutive days in a 21 day cycle.
1130676|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
1130677|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
1130678|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
1130679|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
1130680|NCT00486811|E3|Reported Event|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
1130681|NCT00486811|E2|Reported Event|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
1130682|NCT00486811|E1|Reported Event|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
1130683|NCT00486759|B3|Baseline|Total|Total of all reporting groups
1130684|NCT00486759|B2|Baseline|Placebo + Rituximab + CHOP|Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
1130685|NCT00486759|B1|Baseline|Bevacizumab + Rituximab + CHOP|Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
1130686|NCT00486759|P2|Participant Flow|Placebo + Rituximab + CHOP|Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
1130687|NCT00486759|P1|Participant Flow|Bevacizumab + Rituximab + CHOP|Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
1130688|NCT00486759|O2|Outcome|Placebo + Rituximab + CHOP|Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
1130689|NCT00486759|O1|Outcome|Bevacizumab + Rituximab + CHOP|Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
1130690|NCT00486759|O2|Outcome|Placebo + Rituximab + CHOP|Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
1130691|NCT00486759|O1|Outcome|Bevacizumab + Rituximab + CHOP|Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
1130692|NCT00486759|O2|Outcome|Placebo + Rituximab + CHOP|Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
1130693|NCT00486759|O1|Outcome|Bevacizumab + Rituximab + CHOP|Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
1130694|NCT00486759|E2|Reported Event|Placebo + Rituximab + CHOP|Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
1130695|NCT00486759|E1|Reported Event|Bevacizumab + Rituximab + CHOP|Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
1130696|NCT00486720|B3|Baseline|Total|Total of all reporting groups
1130697|NCT00486720|B2|Baseline|Vorinostat Thrice Daily Dose Schedule|Vorinostat 200 mg three times daily for 14 consecutive days in a 21 day cycle.
1130703|NCT00486720|O2|Outcome|Vorinostat Thrice Daily Dose Schedule|Vorinostat 200 mg three times daily for 14 consecutive days in a 21 day cycle.
1130704|NCT00486720|O1|Outcome|Vorinostat Once Daily Dose Schedule|Vorinostat 400 mg once daily for 14 consecutive days in a 21 day cycle.
1130705|NCT00486720|E2|Reported Event|Vorinostat Thrice Daily Dose Schedule|Vorinostat 200 mg three times daily for 14 consecutive days in a 21 day cycle.
1130706|NCT00486720|E1|Reported Event|Vorinostat Once Daily Dose Schedule|Vorinostat 400 mg once daily for 14 consecutive days in a 21 day cycle.
1130707|NCT00486642|B3|Baseline|Total|Total of all reporting groups
1130708|NCT00486642|B2|Baseline|Arm B - Pazopanib + Bicalutamide|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
1130709|NCT00486642|B1|Baseline|Arm A - Pazopanib|"Patients receive pazopanib hydrochloride PO QD on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
1130710|NCT00486642|P2|Participant Flow|Arm II (Pazopanib & Bicalutamide)|Arm II - Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.
1130711|NCT00486642|P1|Participant Flow|Arm I (Pazopanib)|"Arm I - Patients receive pazopanib hydrochloride PO QD on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
1130712|NCT00486642|O2|Outcome|Arm B - Pazopanib + Bicalutamide|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
1130713|NCT00486642|O1|Outcome|Arm A - Pazopanib|"Patients receive pazopanib hydrochloride PO QD on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
1130714|NCT00486642|O2|Outcome|Arm B - Pazopanib + Bicalutamide|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
1130715|NCT00486642|O1|Outcome|Arm A - Pazopanib|"Patients receive pazopanib hydrochloride PO QD on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
1130716|NCT00486642|O2|Outcome|Arm B (Pazopanib + Bicalutamide)|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
1130717|NCT00486642|O1|Outcome|Arm A (Pazopanib)|"Patients receive pazopanib hydrochloride PO QD on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
1130718|NCT00486642|O2|Outcome|Arm B - Pazopanib + Bicalutamide|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
1130719|NCT00486642|O1|Outcome|Arm A - Pazopanib|"Patients receive pazopanib hydrochloride PO QD on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
1130720|NCT00486642|O2|Outcome|Arm B - Pazopanib + Bicalutamide|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
1130721|NCT00486642|O1|Outcome|Arm A - Pazopanib|"Patients receive pazopanib hydrochloride PO QD on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
1130722|NCT00486642|O2|Outcome|Arm B - Pazopanib + Bicalutamide|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
1130723|NCT00486642|O1|Outcome|Arm A - Pazopanib|"Patients receive pazopanib hydrochloride PO QD on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
1130724|NCT00486642|O2|Outcome|Arm B - Pazopanib + Bicalutamide|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
1130725|NCT00486642|O1|Outcome|Arm A - Pazopanib|"Patients receive pazopanib hydrochloride PO QD on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
1130726|NCT00486642|O2|Outcome|Arm B - Pazopanib + Bicalutamide|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
1130727|NCT00486642|O1|Outcome|Arm A - Pazopanib|"Patients receive pazopanib hydrochloride PO QD on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
1130728|NCT00486642|O2|Outcome|Arm B - Pazopanib + Bicalutamide|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
1131088|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
1130729|NCT00486642|O1|Outcome|Arm A - Pazopanib|"Patients receive pazopanib hydrochloride PO QD on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
1130730|NCT00486642|E2|Reported Event|Arm B - Pazopanib + Bicalutamide|"Patients receive pazopanib hydrochloride PO QD on days 1-28. Patients also receive bicalutamide PO QD on days 8-28 of course 1 and on days 1-28 in all subsequent courses.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
1130731|NCT00486642|E1|Reported Event|Arm A - Pazopanib|"Patients receive pazopanib hydrochloride PO QD on days 1-28.~Laboratory Biomarker Analysis: Correlative studies~Pazopanib Hydrochloride: Given PO~Pharmacological Study: Correlative studies"
1130732|NCT00486525|B3|Baseline|Total|Total of all reporting groups
1130733|NCT00486525|B2|Baseline|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
1130734|NCT00486525|B1|Baseline|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
1130735|NCT00486525|P2|Participant Flow|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
1130736|NCT00486525|P1|Participant Flow|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
1130737|NCT00486525|O2|Outcome|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
1130738|NCT00486525|O1|Outcome|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
1130739|NCT00486525|O2|Outcome|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
1130740|NCT00486525|O1|Outcome|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
1130741|NCT00486525|O2|Outcome|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
1130742|NCT00486525|O1|Outcome|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
1130743|NCT00486525|O2|Outcome|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
1130744|NCT00486525|O1|Outcome|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
1130745|NCT00486525|O2|Outcome|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
1130746|NCT00486525|O1|Outcome|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
1130747|NCT00486525|O2|Outcome|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
1130748|NCT00486525|O1|Outcome|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
1130749|NCT00486525|E2|Reported Event|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
1130750|NCT00486525|E1|Reported Event|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
1130751|NCT00486434|B3|Baseline|Total|Total of all reporting groups
1130752|NCT00486434|B2|Baseline|Placebo Arm|1 SMC021 Placebo tablet twice daily
1130753|NCT00486434|B1|Baseline|Active Arm|0.8mg SMC021 Oral Calcitonin tablet twice daily
1130754|NCT00486434|P2|Participant Flow|Placebo Arm|1 SMC021 Placebo tablet twice daily
1130755|NCT00486434|P1|Participant Flow|Active Arm|0.8mg SMC021 Oral Calcitonin tablet twice daily
1130756|NCT00486434|O2|Outcome|Placebo Arm|1 SMC021 Placebo tablet twice daily
1130757|NCT00486434|O1|Outcome|Active Arm|0.8mg SMC021 Oral Calcitonin tablet twice daily
1130758|NCT00486434|O2|Outcome|Placebo Arm|1 SMC021 Placebo tablet twice daily
1130759|NCT00486434|O1|Outcome|Active Arm|0.8mg SMC021 Oral Calcitonin tablet twice daily
1130760|NCT00486434|O2|Outcome|Placebo Arm|1 SMC021 Placebo tablet twice daily
1130761|NCT00486434|O1|Outcome|Active Arm|0.8mg SMC021 Oral Calcitonin tablet twice daily
1130762|NCT00486434|E2|Reported Event|Placebo Arm|1 SMC021 Placebo tablet twice daily
1130763|NCT00486434|E1|Reported Event|Active Arm|0.8mg SMC021 Oral Calcitonin tablet twice daily
1130764|NCT00486330|B1|Baseline|Tipranavir/Ritonavir (500mg/200mg)|
1130765|NCT00486330|P1|Participant Flow|Tipranavir/Ritonavir (500mg/200mg)|Subjects on buprenorphine maintenance therapy prior to starting the study. Subsequently, tipranavir 500 mg and ritonavir 200 mg (TPV/r) was administered twice daily for a minimum of 7 days. Subjects served as their own controls. PK parameters were evaluated Pre- and Post-administration of tipranavir.
1130964|NCT00486018|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
1130766|NCT00486330|O1|Outcome|Tipranavir/Ritonavir (500mg/200mg)|Subjects on buprenorphine maintenance therapy prior to starting the study. Subsequently, tipranavir 500 mg and ritonavir 200 mg was administered twice daily for a minimum of 7 days. Subjects served as their own controls. PK parameters were evaluated Pre- and Post-administration of tipranavir.
1130767|NCT00486330|E1|Reported Event|Tipranavir/Ritonavir (500mg/200mg)|
1130768|NCT00486291|B3|Baseline|Total|Total of all reporting groups
1130769|NCT00486291|B2|Baseline|Placebo|Matched placebo
1130770|NCT00486291|B1|Baseline|Active|Phentermine 15mg/topiramate 100mg
1130771|NCT00486291|P2|Participant Flow|Placebo|Matched placebo
1130772|NCT00486291|P1|Participant Flow|Active|Phentermine 15mg/topiramate 100mg
1130773|NCT00486291|O2|Outcome|Placebo|Matched placebo
1130774|NCT00486291|O1|Outcome|Active|Phentermine 15mg and topiramate 100mg
1130775|NCT00486291|O2|Outcome|Placebo|Matched placebo
1130776|NCT00486291|O1|Outcome|Active|Phentermine 15mg and topiramate 100mg
1130777|NCT00486291|E2|Reported Event|Placebo|Matched placebo
1130778|NCT00486291|E1|Reported Event|Active|Phentermine 15mg/topiramate 100mg
1130779|NCT00486278|B1|Baseline|All Subjects|A total of 51 subjects with 96 qualifying bleeds were treated in the study. A subject could contribute with up to one qualifying bleeding episode per study arm.
1130780|NCT00486278|P1|Participant Flow|All Subjects|A total of 51 subjects with 96 qualifying bleeds were treated in the study. A subject could contribute with up to one qualifying bleeding episode per study arm.
1130781|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
1130782|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130783|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130784|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130785|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130786|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130787|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
1130788|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130789|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130790|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130791|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130792|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130793|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
1130794|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130795|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130796|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130797|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130798|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1131089|NCT00485472|O2|Outcome|Placebo|Placebo
1130799|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
1130800|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130801|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130802|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130803|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130804|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130805|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
1130806|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130807|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130808|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130809|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130810|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130811|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
1130812|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130813|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130814|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130815|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130816|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130817|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
1130818|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130819|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130820|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130821|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130822|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1131090|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
1131091|NCT00485472|O2|Outcome|Placebo|Placebo
1130823|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
1130824|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130825|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130826|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130827|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130828|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130829|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
1130830|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130831|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130832|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130833|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130834|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130835|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
1130836|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130837|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130838|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130839|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130840|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130841|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
1130842|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130843|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130844|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130845|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130846|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1131092|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
1131093|NCT00485472|O2|Outcome|Placebo|Placebo
1130847|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
1130848|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130849|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130850|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130851|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130852|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130853|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
1130854|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130855|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130856|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130857|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130858|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130859|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
1130860|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130861|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130862|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130863|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130864|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130865|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
1130866|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130867|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130868|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130869|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130870|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1131094|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
1131095|NCT00485472|O2|Outcome|Placebo|Placebo
1130871|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
1130872|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130873|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130874|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130875|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130876|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130877|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
1130878|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130879|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130880|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130881|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130882|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130883|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
1130884|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130885|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130886|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130887|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130888|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130889|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
1130890|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130891|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130892|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130893|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130894|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1131096|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
1131097|NCT00485472|O2|Outcome|Placebo|Placebo
1130895|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
1130896|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130897|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130898|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130899|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130900|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130901|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
1130902|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130903|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130904|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130905|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130906|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130907|NCT00486278|E6|Reported Event|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
1130908|NCT00486278|E5|Reported Event|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130909|NCT00486278|E4|Reported Event|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130910|NCT00486278|E3|Reported Event|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130911|NCT00486278|E2|Reported Event|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130912|NCT00486278|E1|Reported Event|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
1130913|NCT00486265|B1|Baseline|AZD4877|AZD4877 [ Time Frame: administered on days 1,2 and 3]
1130914|NCT00486265|P1|Participant Flow|AZD4877|AZD4877 [ Time Frame: administered on days 1,2 and 3]
1130915|NCT00486265|O1|Outcome|AZD4877|AZD4877 [ Time Frame: administered on days 1,2 and 3]
1130916|NCT00486265|E1|Reported Event|AZD4877|AZD4877 [ Time Frame: administered on days 1,2 and 3]
1130917|NCT00486252|B1|Baseline|Latanoprost All Subjects|Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
1130918|NCT00486252|P1|Participant Flow|Latanoprost All Subjects|Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
1130919|NCT00486252|O3|Outcome|Latanaprost (Prior Beta-blocker Failure)|Subjects previously receiving beta-blocker: Subjects who previously failed beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
1130920|NCT00486252|O2|Outcome|Latanoprost (no Prior Beta-blocker Therapy)|Naive Subject: Subjects with no prior beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
1130921|NCT00486252|O1|Outcome|Latanoprost (All Subjects)|Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
1130922|NCT00486252|O3|Outcome|Latanaprost (Prior Beta-blocker Failure)|Subjects previously receiving beta-blocker: Subjects who previously failed beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
1130923|NCT00486252|O2|Outcome|Latanoprost (no Prior Beta-blocker Therapy)|Naive Subject: Subjects with no prior beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
1130924|NCT00486252|O1|Outcome|Latanoprost (All Subjects)|Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
1130925|NCT00486252|O3|Outcome|Latanaprost (Prior Beta-blocker Failure)|Subjects previously receiving beta-blocker: Subjects who previously failed beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
1130926|NCT00486252|O2|Outcome|Latanoprost (no Prior Beta-blocker Therapy)|Naive Subject: Subjects with no prior beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
1130927|NCT00486252|O1|Outcome|Latanoprost (All Subjects)|Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
1130928|NCT00486252|O3|Outcome|Latanaprost (Prior Beta-blocker Failure)|Subjects previously receiving beta-blocker: Subjects who previously failed beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
1130929|NCT00486252|O2|Outcome|Latanoprost (no Prior Beta-blocker Therapy)|Naive Subject: Subjects with no prior beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
1130930|NCT00486252|O1|Outcome|Latanoprost (All Subjects)|Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
1130931|NCT00486252|E1|Reported Event|Latanoprost All Subjects|Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
1130932|NCT00486226|B1|Baseline|1 Endovascular|"All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device and were consented before the procedure.~Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD"
1130933|NCT00486226|P1|Participant Flow|1 Endovascular|"All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device (VRD).~Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD"
1130934|NCT00486226|O2|Outcome|Endovascular - Occlusion Results at 6 Months Follow-up|Aneurysm occlusion assessed at 6 months follow-up using the Raymond Scale.
1130935|NCT00486226|O1|Outcome|Endovascular - Occlusion Results Immediately Post-procedure|Aneurysm occlusion was assessed immediately post procedure using the Raymond Scale.
1130936|NCT00486226|O1|Outcome|1 Endovascular|"All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device who signed consent before the procedure.~Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD"
1130937|NCT00486226|O1|Outcome|1 Endovascular|"All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device.~Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD"
1130938|NCT00486226|O1|Outcome|1 Endovascular|"All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device who signed consent before the procedure.~Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD"
1130939|NCT00486226|E1|Reported Event|1 Endovascular|"All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device who signed consent before the procedure.~Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD"
1130940|NCT00486044|B3|Baseline|Total|Total of all reporting groups
1130941|NCT00486044|B2|Baseline|Placebo|Matching placebo tablet nightly for 9 months
1130942|NCT00486044|B1|Baseline|Simvastatin|Simvastatin 40 mg tablet nightly for 1 month then 80 mg tablet nightly for 8 months
1130943|NCT00486044|P2|Participant Flow|Placebo|Matching placebo tablet nightly for 9 months
1130944|NCT00486044|P1|Participant Flow|Simvastatin|Simvastatin 40 mg tablet nightly for 1 month then 80 mg tablet nightly for 8 months
1130945|NCT00486044|O2|Outcome|Placebo|Matching placebo tablet nightly for 9 months
1130946|NCT00486044|O1|Outcome|Simvastatin|Simvastatin 40 mg tablet nightly for 1 month then 80 mg tablet nightly for 8 months
1130947|NCT00486044|O2|Outcome|Placebo|Matching placebo tablet nightly for 9 months
1130948|NCT00486044|O1|Outcome|Simvastatin|Simvastatin 40 mg tablet nightly for 1 month then 80 mg tablet nightly for 8 months
1130949|NCT00486044|O2|Outcome|Placebo|Matching placebo tablet nightly for 9 months
1130950|NCT00486044|O1|Outcome|Simvastatin|Simvastatin 40 mg tablet nightly for 1 month then 80 mg tablet nightly for 8 months
1130951|NCT00486044|O2|Outcome|Placebo|Matching placebo tablet nightly for 9 months
1130952|NCT00486044|O1|Outcome|Simvastatin|Simvastatin 40 mg tablet nightly for 1 month then 80 mg tablet nightly for 8 months
1130953|NCT00486044|E2|Reported Event|Placebo|Matching placebo tablet nightly for 9 months
1130954|NCT00486044|E1|Reported Event|Simvastatin|Simvastatin 40 mg tablet nightly for 1 month then 80 mg tablet nightly for 8 months
1130955|NCT00486018|B4|Baseline|Total|Total of all reporting groups
1130956|NCT00486018|B3|Baseline|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1130957|NCT00486018|B2|Baseline|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1130958|NCT00486018|B1|Baseline|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
1130959|NCT00486018|P3|Participant Flow|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1130960|NCT00486018|P2|Participant Flow|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1130961|NCT00486018|P1|Participant Flow|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
1130962|NCT00486018|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1130963|NCT00486018|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1130965|NCT00486018|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1130966|NCT00486018|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1130967|NCT00486018|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
1130968|NCT00486018|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1130969|NCT00486018|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1130970|NCT00486018|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
1130971|NCT00486018|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1130972|NCT00486018|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1130973|NCT00486018|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
1130974|NCT00486018|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1130975|NCT00486018|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1130976|NCT00486018|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
1130977|NCT00486018|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1130978|NCT00486018|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1130979|NCT00486018|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
1130980|NCT00486018|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1130981|NCT00486018|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1130982|NCT00486018|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
1130983|NCT00486018|E3|Reported Event|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1130984|NCT00486018|E2|Reported Event|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1130985|NCT00486018|E1|Reported Event|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
1130986|NCT00485953|B3|Baseline|Total|Total of all reporting groups
1130987|NCT00485953|B2|Baseline|Placebo Group|Received placebo medication once per week
1130988|NCT00485953|B1|Baseline|Active Medicine Group|risedronate 35 mg weekly
1130989|NCT00485953|P2|Participant Flow|Placebo Group|Received placebo medication once per week
1130990|NCT00485953|P1|Participant Flow|Active Medication Group|"risedronate 35 mg weekly~risedronate: risedronate 35 mg per week"
1130991|NCT00485953|O2|Outcome|Placebo Group|Received placebo medication once weekly
1130992|NCT00485953|O1|Outcome|Active Medicine Group|risedronate 35 mg weekly
1130993|NCT00485953|E2|Reported Event|Placebo Group|Receive placebo medication once per week
1130994|NCT00485953|E1|Reported Event|Active Medicine Group|risedronate 35 mg weekly
1130995|NCT00485836|B4|Baseline|Total|Total of all reporting groups
1130996|NCT00485836|B3|Baseline|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1130997|NCT00485836|B2|Baseline|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1130998|NCT00485836|B1|Baseline|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
1130999|NCT00485836|P3|Participant Flow|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1131000|NCT00485836|P2|Participant Flow|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1131001|NCT00485836|P1|Participant Flow|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
1131002|NCT00485836|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1131003|NCT00485836|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1131004|NCT00485836|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
1131098|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
1131005|NCT00485836|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1131006|NCT00485836|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1131007|NCT00485836|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
1131008|NCT00485836|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1131009|NCT00485836|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1131010|NCT00485836|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
1131011|NCT00485836|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1131012|NCT00485836|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1131013|NCT00485836|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
1131014|NCT00485836|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1131015|NCT00485836|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1131016|NCT00485836|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
1131017|NCT00485836|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1131018|NCT00485836|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1131019|NCT00485836|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
1131020|NCT00485836|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1131021|NCT00485836|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1131022|NCT00485836|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
1131023|NCT00485836|E3|Reported Event|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1131024|NCT00485836|E2|Reported Event|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
1131025|NCT00485836|E1|Reported Event|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
1131026|NCT00485758|B3|Baseline|Total|Total of all reporting groups
1131027|NCT00485758|B2|Baseline|Placebo|Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study.
1131028|NCT00485758|B1|Baseline|Extended Release Niacin/Laropiprant|"One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram).~No adjustments were made to any lipid modifying regimen established during run-in until Week 12."
1131029|NCT00485758|P2|Participant Flow|Placebo|Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study.
1131030|NCT00485758|P1|Participant Flow|Extended Release Niacin/Laropiprant|"One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram).~No adjustments were made to any lipid modifying regimen established during run-in until Week 12."
1131031|NCT00485758|O2|Outcome|Placebo|Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study.
1131032|NCT00485758|O1|Outcome|Extended Release Niacin/Laropiprant|"One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram).~No adjustments were made to any lipid modifying regimen established during run-in until Week 12."
1131033|NCT00485758|O2|Outcome|Placebo|Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study.
1131034|NCT00485758|O1|Outcome|Extended Release Niacin/Laropiprant|"One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram).~No adjustments were made to any lipid modifying regimen established during run-in until Week 12."
1131035|NCT00485758|O2|Outcome|Placebo|Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study.
1131036|NCT00485758|O1|Outcome|Extended Release Niacin/Laropiprant|"One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram).~No adjustments were made to any lipid modifying regimen established during run-in until Week 12."
1131037|NCT00485758|E2|Reported Event|Placebo|Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study.
1131099|NCT00485472|O2|Outcome|Placebo|Placebo
1131100|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
1131101|NCT00485472|E2|Reported Event|Placebo|Placebo
1131102|NCT00485472|E1|Reported Event|Lacosamide|Lacosamide (LCM) 400 mg/day
1131112|NCT00485433|O4|Outcome|SKY0402 High Dose|A single dose of SKY0402 diluted to a 42-mL injection volume administered via local infiltration during surgery
1131038|NCT00485758|E1|Reported Event|Extended Release Niacin/Laropiprant|"One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram).~No adjustments were made to any lipid modifying regimen established during run-in until Week 12."
1131039|NCT00485732|B3|Baseline|Total|Total of all reporting groups
1131040|NCT00485732|B2|Baseline|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
1131041|NCT00485732|B1|Baseline|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
1131042|NCT00485732|P2|Participant Flow|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
1131043|NCT00485732|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
1131044|NCT00485732|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
1131045|NCT00485732|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
1131046|NCT00485732|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
1131047|NCT00485732|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
1131048|NCT00485732|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
1131049|NCT00485732|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
1131050|NCT00485732|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
1131051|NCT00485732|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
1131052|NCT00485732|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
1131053|NCT00485732|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
1131054|NCT00485732|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
1131055|NCT00485732|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
1131056|NCT00485732|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
1131057|NCT00485732|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
1131058|NCT00485732|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
1131059|NCT00485732|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
1131060|NCT00485732|E2|Reported Event|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
1131061|NCT00485732|E1|Reported Event|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
1131062|NCT00485693|B3|Baseline|Total|Total of all reporting groups
1131063|NCT00485693|B2|Baseline|SKY0402|A single dose of study drug was to be administered intraoperatively via local infiltration
1131064|NCT00485693|B1|Baseline|Bupivacaine HCl|A single dose of study drug was to be administered intraoperatively via local infiltration
1131065|NCT00485693|P2|Participant Flow|SKY0402|A single dose of study drug was to be administered intraoperatively via local infiltration
1131066|NCT00485693|P1|Participant Flow|Bupivacaine HCl|A single dose of study drug was to be administered intraoperatively via local infiltration
1131067|NCT00485693|O5|Outcome|SKY0402 High Dose|Single administration of study drug in a volume of 60 mL via local infiltration
1131068|NCT00485693|O4|Outcome|SKY0402 High-mid Dose|Single administration of study drug in a volume of 60 mL via local infiltration
1131069|NCT00485693|O3|Outcome|SKY0402 Low-mid Dose|Single administration of study drug in a volume of 60 mL via local infiltration
1131070|NCT00485693|O2|Outcome|SKY0402 Low Dose|Single administration of study drug in a volume of 60 mL via local infiltration
1131071|NCT00485693|O1|Outcome|Bupivacaine HCl|Single administration of 150 mg bupivacaine HCl in a 60-mL injection volume (undiluted)
1131072|NCT00485693|E2|Reported Event|SKY0402|A single dose of study drug was to be administered intraoperatively via local infiltration
1131073|NCT00485693|E1|Reported Event|Bupivacaine HCl|A single dose of study drug was to be administered intraoperatively via local infiltration
1131074|NCT00485485|B1|Baseline|Imatinib Mesylate + Docetaxel|Imatinib 400 mg orally daily; Docetaxel 60 mg/m^2 by vein over 1 hour every 3 weeks
1131075|NCT00485485|P1|Participant Flow|Imatinib Mesylate + Docetaxel|Imatinib 400 mg orally daily; Docetaxel 60 mg/m^2 by vein over 1 hour every 3 weeks
1131076|NCT00485485|O1|Outcome|Imatinib Mesylate + Docetaxel|Imatinib 400 mg orally daily; Docetaxel 60 mg/m^2 by vein over 1 hour every 3 weeks
1131077|NCT00485485|E1|Reported Event|Imatinib Mesylate + Docetaxel|Imatinib 400 mg orally daily; Docetaxel 60 mg/m^2 by vein over 1 hour every 3 weeks
1131078|NCT00485472|B3|Baseline|Total|Total of all reporting groups
1131079|NCT00485472|B2|Baseline|Placebo|Placebo
1131080|NCT00485472|B1|Baseline|Lacosamide|Lacosamide (LCM) 400 mg/day
1131081|NCT00485472|P2|Participant Flow|Placebo|Placebo
1131082|NCT00485472|P1|Participant Flow|Lacosamide|Lacosamide (LCM) 400 mg/day
1131083|NCT00485472|O2|Outcome|Placebo|Placebo
1131084|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
1131085|NCT00485472|O2|Outcome|Placebo|Placebo
1131086|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
1131087|NCT00485472|O2|Outcome|Placebo|Placebo
1131113|NCT00485433|O3|Outcome|SKY0402 Middle Dose|A single dose of SKY0402 diluted to a 42-mL injection volume administered via local infiltration during surgery
1131114|NCT00485433|O2|Outcome|SKY0402 Low Dose|A single dose of SKY0402 diluted to a 42-mL injection volume administered via local infiltration during surgery
1131115|NCT00485433|O1|Outcome|Bupivacaine HCl 105mg|A single dose of 105 mg bupivacaine in a 42-mL injection volume administered via local infiltration during surgery
1131116|NCT00485433|E2|Reported Event|SKY0402 (All Doses)|SKY0402 given during hernia repair
1131117|NCT00485433|E1|Reported Event|Bupivacaine HCl 105mg|Bupivacaine HCl given during hernia repair
1131118|NCT00485303|B1|Baseline|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
1131119|NCT00485303|P1|Participant Flow|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
1131120|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
1131121|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
1131122|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
1131123|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
1131124|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
1131125|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
1131126|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
1131127|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
1131128|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
1131129|NCT00485303|E1|Reported Event|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
1131130|NCT00485264|B7|Baseline|Total|Total of all reporting groups
1131131|NCT00485264|B6|Baseline|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
1131132|NCT00485264|B5|Baseline|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
1131133|NCT00485264|B4|Baseline|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
1131134|NCT00485264|B3|Baseline|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
1131135|NCT00485264|B2|Baseline|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
1131136|NCT00485264|B1|Baseline|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
1131137|NCT00485264|P6|Participant Flow|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
1131138|NCT00485264|P5|Participant Flow|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
1131139|NCT00485264|P4|Participant Flow|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
1131357|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
1131358|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
1131140|NCT00485264|P3|Participant Flow|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
1131141|NCT00485264|P2|Participant Flow|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
1131142|NCT00485264|P1|Participant Flow|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
1131143|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
1131144|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
1131145|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
1131146|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
1131147|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
1131148|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
1131149|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
1131150|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
1131151|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
1131152|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
1131153|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
1131154|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
1131155|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
1131156|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
1131157|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
1131158|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
1131159|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
1131160|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
1131161|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
1131162|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
1131163|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
1131164|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
1131165|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
1131166|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
1131349|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
1131167|NCT00485264|O6|Outcome|Cohort V -Data Not Included in This Interim Analysis.|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
1131168|NCT00485264|O5|Outcome|Cohort IV -Data Not Included in This Interim Analysis.|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
1131169|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
1131170|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
1131171|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
1131172|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
1131173|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
1131174|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
1131175|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
1131176|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
1131177|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
1131178|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
1131179|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
1131180|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
1131181|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
1131182|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
1131183|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
1131184|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
1131185|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
1131186|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
1131187|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
1131188|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
1131189|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
1131190|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
1131191|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
1131192|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
1131350|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
1131193|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
1131194|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
1131195|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
1131196|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
1131197|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
1131198|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
1131199|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
1131200|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
1131201|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
1131202|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
1131203|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
1131204|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
1131205|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
1131206|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
1131207|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
1131208|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
1131209|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
1131210|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
1131211|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
1131212|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
1131213|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
1131214|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
1131215|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
1131216|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
1131217|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
1131218|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
1131219|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
1131351|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
1131220|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
1131221|NCT00485264|E4|Reported Event|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
1131222|NCT00485264|E3|Reported Event|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
1131223|NCT00485264|E2|Reported Event|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
1131224|NCT00485264|E1|Reported Event|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
1131225|NCT00485173|B3|Baseline|Total|Total of all reporting groups
1131226|NCT00485173|B2|Baseline|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
1131227|NCT00485173|B1|Baseline|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
1131228|NCT00485173|P2|Participant Flow|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
1131229|NCT00485173|P1|Participant Flow|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
1131230|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
1131231|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
1131232|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
1131233|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
1131234|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
1131235|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
1131236|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
1131237|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
1131238|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
1131239|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
1131240|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
1131241|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
1131242|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
1131243|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
1131244|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
1131245|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
1131246|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
1131247|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
1131248|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
1131249|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
1131352|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
1131353|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
1131354|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
1131250|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
1131251|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
1131252|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
1131253|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
1131254|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
1131255|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
1131256|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
1131257|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
1131258|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
1131259|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
1131260|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
1131261|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
1131262|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
1131263|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
1131264|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
1131265|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
1131266|NCT00485173|E2|Reported Event|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
1131267|NCT00485173|E1|Reported Event|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
1131268|NCT00485069|B3|Baseline|Total|Total of all reporting groups
1131269|NCT00485069|B2|Baseline|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
1131270|NCT00485069|B1|Baseline|ROP+L-Dopa|Participants received ropinirole hydrochloride (ROP) tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 milligrams (mg)/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
1131271|NCT00485069|P2|Participant Flow|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day and was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals of at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
1131272|NCT00485069|P1|Participant Flow|ROP+L-Dopa|Participants received ropinirole hydrochloride (ROP) tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 milligrams (mg)/day and was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals of at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
1131273|NCT00485069|O2|Outcome|"ROP+L-Dopa, On Hours"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
1131274|NCT00485069|O1|Outcome|"ROP+L-Dopa, Off Hours"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
1131275|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
1131276|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
1131277|NCT00485069|O1|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
1131278|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
1131279|NCT00485069|O1|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
1131280|NCT00485069|O2|Outcome|"ROP+L-Dopa, Off State (Only Participants With Off State)"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
1131281|NCT00485069|O1|Outcome|"ROP+L-Dopa, On State"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
1131282|NCT00485069|O1|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
1131283|NCT00485069|O2|Outcome|"ROP+L-Dopa, Off State (Only Participants With Off State)"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
1131284|NCT00485069|O1|Outcome|"ROP+L-Dopa, On State"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
1131285|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
1131286|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
1131287|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
1131288|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
1131289|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
1131290|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
1131291|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
1131292|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
1131293|NCT00485069|O1|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
1131294|NCT00485069|O2|Outcome|"ROP+L-Dopa, Off State (Only Participants With Off State)"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
1131295|NCT00485069|O1|Outcome|"ROP+L-Dopa, On State"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
1131296|NCT00485069|O1|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
1131297|NCT00485069|O2|Outcome|"ROP+L-Dopa, Off Sate (Only Participants With Off State)"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
1131298|NCT00485069|O1|Outcome|"ROP+L-Dopa, On State"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
1131299|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
1131355|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
1131300|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
1131301|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
1131302|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
1131303|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
1131304|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
1131305|NCT00485069|O1|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
1131306|NCT00485069|O2|Outcome|"ROP+L-Dopa, Off State (Only Participants With Off State)"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
1131307|NCT00485069|O1|Outcome|"ROP+L-Dopa, On State"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
1131308|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
1131309|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
1131310|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
1131311|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ropinirole hydrochloride (ROP) tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 milligrams (mg)/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
1131312|NCT00485069|E2|Reported Event|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
1131356|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
1131313|NCT00485069|E1|Reported Event|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
1131314|NCT00484939|B3|Baseline|Total|Total of all reporting groups
1131315|NCT00484939|B2|Baseline|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
1131316|NCT00484939|B1|Baseline|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
1131317|NCT00484939|P2|Participant Flow|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
1131318|NCT00484939|P1|Participant Flow|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
1131319|NCT00484939|O2|Outcome|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
1131320|NCT00484939|O1|Outcome|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
1131321|NCT00484939|O2|Outcome|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
1131322|NCT00484939|O1|Outcome|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
1131323|NCT00484939|O2|Outcome|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
1131324|NCT00484939|O1|Outcome|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
1131325|NCT00484939|O2|Outcome|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
1131326|NCT00484939|O1|Outcome|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
1131327|NCT00484939|O2|Outcome|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
1131328|NCT00484939|O1|Outcome|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
1131329|NCT00484939|O2|Outcome|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
1131330|NCT00484939|O1|Outcome|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
1131331|NCT00484939|O2|Outcome|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
1131332|NCT00484939|O1|Outcome|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
1131333|NCT00484939|O2|Outcome|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
1131334|NCT00484939|O1|Outcome|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
1131335|NCT00484939|E2|Reported Event|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
1131336|NCT00484939|E1|Reported Event|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
1131337|NCT00484679|B1|Baseline|(Kenalog-10) Intralesional Injections for Alopecia Areata|Patients received Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections every 6 weeks for 6 months. Disease extent and efficacy was assessed along with safety studies involving regularly scheduled ACTH stimulation tests.
1131338|NCT00484679|P1|Participant Flow|(Kenalog-10) Intralesional Injections for Alopecia Areata|Patients received Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections every 6 weeks for 6 months. Disease extent and efficacy was assessed along with safety studies involving regularly scheduled ACTH stimulation tests.
1131339|NCT00484679|O1|Outcome|(Kenalog-10) Intralesional Injections for Alopecia Areata|Patients received Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections every 6 weeks for 6 months. Disease extent and efficacy was assessed along with safety studies involving regularly scheduled ACTH stimulation tests.
1131340|NCT00484679|E1|Reported Event|(Kenalog-10) Intralesional Injections for Alopecia Areata|Patients received Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections every 6 weeks for 6 months. Disease extent and efficacy was assessed along with safety studies involving regularly scheduled ACTH stimulation tests.
1131341|NCT00484419|B4|Baseline|Total|Total of all reporting groups
1131342|NCT00484419|B3|Baseline|Sitagliptin|sitagliptin phosphate tablets 100mg
1131343|NCT00484419|B2|Baseline|Rosiglitazone|rosiglitazone maleate 4mg
1131344|NCT00484419|B1|Baseline|Colesevelam|colesevelam tablets 625 mg
1140874|NCT00460239|O5|Outcome|Buprenorphine 16 mg|
1131381|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
1131382|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
1131383|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
1131384|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
1131385|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
1131386|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
1131387|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
1131388|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
1131389|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
1131390|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
1131391|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
1131392|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
1131393|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
1131394|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
1131395|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
1131396|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
1131397|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
1131398|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
1131399|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
1131400|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
1131401|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
1131402|NCT00484393|B3|Baseline|Total|Total of all reporting groups
1131403|NCT00484393|B2|Baseline|Placebo First|Placebo cream (Aquatain) 1g applied to inejction site first, then tetracaine with subsequent injection
1131404|NCT00484393|B1|Baseline|Tetracaine First|Tetracaine 4% gel 1g applied to injection site first, then placebo with subsequent injection
1131405|NCT00484393|P2|Participant Flow|Placebo Then Tetracaine|Placebo cream (Aquatain) 1g applied to inejction site prior to next palivizumab injection after enrollment Tetracaine 4% gel 1g applied to injection site prior to subsequent palivizumab injection (1 month after 1st study injection)
1131406|NCT00484393|P1|Participant Flow|Tetracaine Then Placebo|Tetracaine 4% gel 1g applied to injection site prior to next palivizumab injection after enrollment Placebo cream (Aquatain) 1g applied to inejction site prior to subsequent palivizumab injection (1 month after 1st study injection)
1131407|NCT00484393|O2|Outcome|Placebo|Placebo cream (Aquatain) 1g applied to inejction site
1131408|NCT00484393|O1|Outcome|Tetracaine|Tetracaine 4% gel 1g applied to injection site
1131409|NCT00484393|E2|Reported Event|Placebo|"Placebo cream (Aquatain) 1g applied to inejction site~Placebo: placebo applied prior to 1 injection"
1131410|NCT00484393|E1|Reported Event|Tetracaine|"Tetracaine 4% gel 1g applied to injection site~tetracaine 4% gel: tetracaine applied prior to 1 injection"
1131411|NCT00484315|B3|Baseline|Total|Total of all reporting groups
1131412|NCT00484315|B2|Baseline|TAXUS Express|Participants randomized to treatment with TAXUS Express paclitaxel-eluting stent (control device)
1131413|NCT00484315|B1|Baseline|TAXUS Element|Participants randomized to treatment with TAXUS Element paclitaxel-eluting stent (investigational device)
1131414|NCT00484315|P2|Participant Flow|TAXUS Express|Participants randomized to treatment with TAXUS Express paclitaxel-eluting stent (control device)
1131415|NCT00484315|P1|Participant Flow|TAXUS Element|Participants randomized to treatment with TAXUS Element paclitaxel-eluting stent (investigational device)
1131416|NCT00484315|O2|Outcome|TAXUS Express|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
1131417|NCT00484315|O1|Outcome|TAXUS Element|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
1131418|NCT00484315|O2|Outcome|TAXUS Express|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
1131419|NCT00484315|O1|Outcome|TAXUS Element|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
1131420|NCT00484315|E2|Reported Event|TAXUS Express|Participants randomized to treatment with TAXUS Express paclitaxel-eluting stent (control device)
1132433|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
1131421|NCT00484315|E1|Reported Event|TAXUS Element|Participants randomized to treatment with TAXUS Element paclitaxel-eluting stent (investigational device)
1131422|NCT00484289|B4|Baseline|Total|Total of all reporting groups
1131423|NCT00484289|B3|Baseline|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131424|NCT00484289|B2|Baseline|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131425|NCT00484289|B1|Baseline|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
1131426|NCT00484289|P3|Participant Flow|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131527|NCT00484159|O1|Outcome|Double-block Group|Radiofrequency lumbar facet joint denervation only if positive response to 2 diagnostic facet blocks.
1131725|NCT00483652|E2|Reported Event|Placebo Treatment|Placebo b.i.d. dosing for 9 weeks
1131427|NCT00484289|P2|Participant Flow|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131428|NCT00484289|P1|Participant Flow|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
1131429|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131430|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131431|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
1131432|NCT00484289|O1|Outcome|All Participants From IM101-129 Study|Participants with rheumatoid arthritis (RA) who participated in studies IM101-034 and IM101-071. Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Weeks 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
1131433|NCT00484289|O1|Outcome|All Participants From IM101-129 Study|Participants with rheumatoid arthritis (RA) who participated in studies IM101-034 and IM101-071. Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Weeks 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
1131434|NCT00484289|O1|Outcome|All Participants From IM101-129 Study|Participants with rheumatoid arthritis (RA) who participated in studies IM101-034 and IM101-071. Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Weeks 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
1131435|NCT00484289|O1|Outcome|All Participants From IM101-129 Study|Participants with rheumatoid arthritis (RA) who participated in studies IM101-034 and IM101-071. Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Weeks 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
1131436|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131437|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131438|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
1131439|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131590|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131440|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131441|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
1131442|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131443|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131444|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
1131445|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131446|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131447|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
1131448|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131449|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131450|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
1131451|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131452|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131453|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
1131454|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131455|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131456|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
1131457|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131458|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131459|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
1131460|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131461|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131462|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
1131463|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131464|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131465|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
1131466|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131467|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131468|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
1131469|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131470|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131471|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
1131472|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131473|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131474|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
1131475|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131476|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131477|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
1131478|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131479|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131480|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
1131481|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131482|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131483|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
1131484|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131485|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131486|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
1131487|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131488|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131489|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
1131490|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131491|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131492|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
1131493|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131494|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131495|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
1131496|NCT00484289|E3|Reported Event|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131497|NCT00484289|E2|Reported Event|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
1131498|NCT00484289|E1|Reported Event|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
1131499|NCT00484185|B1|Baseline|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
1131500|NCT00484185|P1|Participant Flow|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
1131501|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
1131502|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
1131503|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
1131504|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
1131505|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
1131506|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
1131507|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
1131508|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
1131509|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
1131510|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
1131511|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
1131512|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
1131513|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
1131514|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
1131515|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
1131516|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
1131517|NCT00484185|E1|Reported Event|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
1131518|NCT00484159|B4|Baseline|Total|Total of all reporting groups
1131519|NCT00484159|B3|Baseline|Radiofrequency Group|Radiofrequency lumbar facet denervation without a diagnostic facet block.
1131520|NCT00484159|B2|Baseline|Single-block Group|Radiofrequency lumbar facet joint denervation if positive response to single facet joint block.
1131521|NCT00484159|B1|Baseline|Double-block Group|Radiofrequency lumbar facet joint denervation only if positive response to 2 diagnostic facet blocks.
1131522|NCT00484159|P3|Participant Flow|Radiofrequency Group|Radiofrequency lumbar facet denervation without a diagnostic facet block.
1131523|NCT00484159|P2|Participant Flow|Single-block Group|Radiofrequency lumbar facet joint denervation if positive response to single facet joint block.
1131524|NCT00484159|P1|Participant Flow|Double-block Group|Radiofrequency lumbar facet joint denervation only if positive response to 2 diagnostic facet blocks.
1131525|NCT00484159|O3|Outcome|Radiofrequency Group|Radiofrequency lumbar facet denervation without a diagnostic facet block.
1131526|NCT00484159|O2|Outcome|Single-block Group|Radiofrequency lumbar facet joint denervation if positive response to single facet joint block.
1131528|NCT00484159|O3|Outcome|Radiofrequency Group|Radiofrequency lumbar facet denervation without a diagnostic facet block.
1131529|NCT00484159|O2|Outcome|Single-block Group|Radiofrequency lumbar facet joint denervation if positive response to single facet joint block.
1131530|NCT00484159|O1|Outcome|Double-block Group|Radiofrequency lumbar facet joint denervation only if positive response to 2 diagnostic facet blocks.
1131531|NCT00484159|E3|Reported Event|Radiofrequency Group|Radiofrequency lumbar facet denervation without a diagnostic facet block.
1131532|NCT00484159|E2|Reported Event|Single-block Group|Radiofrequency lumbar facet joint denervation if positive response to single facet joint block.
1131533|NCT00484159|E1|Reported Event|Double-block Group|Radiofrequency lumbar facet joint denervation only if positive response to 2 diagnostic facet blocks.
1131534|NCT00484094|B1|Baseline|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
1131535|NCT00484094|P1|Participant Flow|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
1131536|NCT00484094|O1|Outcome|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
1131537|NCT00484094|O1|Outcome|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
1131538|NCT00484094|O1|Outcome|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
1131539|NCT00484094|O1|Outcome|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
1131540|NCT00484094|O1|Outcome|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
1131541|NCT00484094|O1|Outcome|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
1131542|NCT00484094|E1|Reported Event|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
1131543|NCT00483938|B8|Baseline|Total|Total of all reporting groups
1131544|NCT00483938|B7|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group NR)|Participants who did not have any change in HCV-RNA levels at Weeks 4, 8, and 12 were not randomized (NR) to any of the other groups. Participants received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
1131545|NCT00483938|B6|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group F)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
1131546|NCT00483938|B5|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group E)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
1131547|NCT00483938|B4|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group D)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
1131548|NCT00483938|B3|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group C)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
1132434|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
1131549|NCT00483938|B2|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group B)|Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
1131550|NCT00483938|B1|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group A)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
1131551|NCT00483938|P7|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group NR)|Participants who did not have any change in HCV-RNA levels at Weeks 4, 8, and 12 were not randomized (NR) to any of the other groups. Participants received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
1131552|NCT00483938|P6|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group F)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
1131553|NCT00483938|P5|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group E)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
1131721|NCT00483652|O2|Outcome|Placebo Treatment|Placebo b.i.d. dosing for 9 weeks
1131722|NCT00483652|O1|Outcome|Fampridine-SR 10 mg b.i.d. Treatment|Fampridine-SR 10 mg b.i.d. dosing for 9 weeks
1131554|NCT00483938|P4|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group D)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
1131555|NCT00483938|P3|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group C)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
1131556|NCT00483938|P2|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group B)|Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
1131557|NCT00483938|P1|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group A)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
1131558|NCT00483938|O6|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group F)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
1131559|NCT00483938|O5|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group E)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
1131560|NCT00483938|O4|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group D)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
1131561|NCT00483938|O3|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group C)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
1131562|NCT00483938|O2|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group B)|Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
1131563|NCT00483938|O1|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group A)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
1131564|NCT00483938|O4|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group F)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
1131565|NCT00483938|O3|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group E)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
1131566|NCT00483938|O2|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group D)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
1131567|NCT00483938|O1|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group C)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
1131568|NCT00483938|O2|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group B)|Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
1131666|NCT00483717|E1|Reported Event|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
1131569|NCT00483938|O1|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group A)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
1131570|NCT00483938|E7|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group NR)|Participants who did not have any change in HCV-RNA levels at Weeks 4, 8, and 12 were not randomized (NR) to any of the other groups. Participants received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
1131571|NCT00483938|E6|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group F)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
1131572|NCT00483938|E5|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group E)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
1131573|NCT00483938|E4|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group D)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
1131574|NCT00483938|E3|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group C)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
1131575|NCT00483938|E2|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group B)|Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
1131576|NCT00483938|E1|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group A)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
1131577|NCT00483756|B4|Baseline|Total|Total of all reporting groups
1131578|NCT00483756|B3|Baseline|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131579|NCT00483756|B2|Baseline|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131580|NCT00483756|B1|Baseline|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
1131581|NCT00483756|P3|Participant Flow|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131582|NCT00483756|P2|Participant Flow|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131583|NCT00483756|P1|Participant Flow|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
1131584|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131585|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131586|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
1131587|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131588|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131589|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
1131667|NCT00483704|B4|Baseline|Total|Total of all reporting groups
1131591|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131592|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
1131593|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131594|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131595|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
1131723|NCT00483652|O2|Outcome|Placebo Treatment|Placebo b.i.d. dosing for 9 weeks
1131596|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131597|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131598|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
1131599|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131600|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131601|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
1131602|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131603|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131604|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
1131605|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131606|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131607|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
1131608|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131609|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131610|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
1131611|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131690|NCT00483704|O2|Outcome|Telcagepant 280 mg|Participants who received at least one dose of telcagepant 280 mg.
1131691|NCT00483704|O1|Outcome|Telcagepant 140 mg|Participants who received at least one dose of telcagepant 140 mg.
1131612|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131613|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
1131614|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131615|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131616|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
1131617|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131618|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131619|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
1131620|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131621|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131622|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
1131623|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131624|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131625|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
1131626|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131627|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131628|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
1131629|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131630|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131631|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
1131632|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131823|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
1131633|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131634|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
1131635|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131636|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131637|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
1131638|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131639|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131640|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
1131641|NCT00483756|E3|Reported Event|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131642|NCT00483756|E2|Reported Event|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
1131643|NCT00483756|E1|Reported Event|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
1131644|NCT00483717|B3|Baseline|Total|Total of all reporting groups
1131645|NCT00483717|B2|Baseline|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
1131646|NCT00483717|B1|Baseline|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
1131647|NCT00483717|P2|Participant Flow|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
1131648|NCT00483717|P1|Participant Flow|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
1131649|NCT00483717|O2|Outcome|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
1131650|NCT00483717|O1|Outcome|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
1131651|NCT00483717|O2|Outcome|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
1131652|NCT00483717|O1|Outcome|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
1131653|NCT00483717|O2|Outcome|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
1131654|NCT00483717|O1|Outcome|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
1131655|NCT00483717|O2|Outcome|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
1131656|NCT00483717|O1|Outcome|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
1131657|NCT00483717|O2|Outcome|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
1131658|NCT00483717|O1|Outcome|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
1131659|NCT00483717|O2|Outcome|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
1131660|NCT00483717|O1|Outcome|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
1131661|NCT00483717|O2|Outcome|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
1131662|NCT00483717|O1|Outcome|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
1131663|NCT00483717|O2|Outcome|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
1131664|NCT00483717|O1|Outcome|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
1131665|NCT00483717|E2|Reported Event|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
1140875|NCT00460239|O4|Outcome|Buprenorphine 8 mg|
1131668|NCT00483704|B3|Baseline|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
1131669|NCT00483704|B2|Baseline|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
1131670|NCT00483704|B1|Baseline|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
1131671|NCT00483704|P3|Participant Flow|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
1131724|NCT00483652|O1|Outcome|Fampridine-SR 10 mg b.i.d. Treatment|Fampridine-SR 10 mg b.i.d. dosing for 9 weeks
1131672|NCT00483704|P2|Participant Flow|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
1131673|NCT00483704|P1|Participant Flow|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
1131674|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
1131675|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
1131676|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
1131677|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
1131678|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
1131679|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
1131680|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
1131681|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
1131682|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
1131683|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
1131684|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
1131685|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
1131686|NCT00483704|O3|Outcome|Placebo|Participants who received at least one dose of placebo.
1131687|NCT00483704|O2|Outcome|Telcagepant 280 mg|Participants who received at least one dose of telcagepant 280 mg.
1131688|NCT00483704|O1|Outcome|Telcagepant 140 mg|Participants who received at least one dose of telcagepant 140 mg.
1131689|NCT00483704|O3|Outcome|Placebo|Participants who received at least one dose of placebo.
1131692|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
1131693|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
1131694|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
1131695|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
1131696|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
1131697|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
1131698|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
1131699|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
1131700|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
1131701|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
1131702|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
1131703|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
1131704|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
1131705|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
1131706|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
1131707|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
1131708|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
1131709|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
1131710|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
1131711|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
1131712|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
1131713|NCT00483704|E3|Reported Event|Placebo|Participants who received at least one dose of placebo.
1131714|NCT00483704|E2|Reported Event|Telcagepant 280 mg|Participants who received at least one dose of telcagepant 280 mg.
1131715|NCT00483704|E1|Reported Event|Telcagepant 140 mg|Participants who received at least one dose of telcagepant 140 mg.
1131716|NCT00483652|B3|Baseline|Total|Total of all reporting groups
1131717|NCT00483652|B2|Baseline|Placebo Treatment|Placebo b.i.d. dosing for 9 weeks
1131718|NCT00483652|B1|Baseline|Fampridine-SR 10 mg b.i.d. Treatment|Fampridine-SR 10 mg b.i.d. dosing for 9 weeks
1131719|NCT00483652|P2|Participant Flow|Placebo Treatment|Placebo b.i.d. dosing for 9 weeks
1131720|NCT00483652|P1|Participant Flow|Fampridine-SR 10 mg b.i.d. Treatment|Fampridine-SR 10 mg b.i.d. dosing for 9 weeks
1131726|NCT00483652|E1|Reported Event|Fampridine-SR 10 mg b.i.d. Treatment|Fampridine-SR 10 mg b.i.d. dosing for 9 weeks
1131727|NCT00483574|B3|Baseline|Total|Total of all reporting groups
1131728|NCT00483574|B2|Baseline|Group 2: Routine Pediatric Vaccines|Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
1131729|NCT00483574|B1|Baseline|Group 1: Menactra and Routine Pediatric Vaccines|Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M‑M‑R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
1131730|NCT00483574|P2|Participant Flow|Group 2: Routine Pediatric Vaccines|Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
1131731|NCT00483574|P1|Participant Flow|Group 1: Menactra and Routine Pediatric Vaccines|Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M‑M‑R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
1131732|NCT00483574|O2|Outcome|Group 2: Routine Pediatric Vaccines|Participants received routine pediatric vaccines (measles-mumps-rubella-varicella [MMRV: ProQuad], pneumococcal conjugate[PCV], and hepatitis A [HepA]) at age 12 months.
1131733|NCT00483574|O1|Outcome|Group 1: Menactra and Routine Pediatric Vaccines|Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines (measles-mumps-rubella-varicella [MMR+V: ProQuad], pneumococcal conjugate [PCV], and hepatitis A [HepA]) at age 12 months. (0.5 mL, intramuscular, respectively)
1131734|NCT00483574|O2|Outcome|Group 2: Routine Pediatric Vaccines|Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
1131735|NCT00483574|O1|Outcome|Group 1: Menactra and Routine Pediatric Vaccines|Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M‑M‑R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
1131736|NCT00483574|E2|Reported Event|Group 2: Routine Pediatric Vaccines|Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
1131737|NCT00483574|E1|Reported Event|Group 1: Menactra and Routine Pediatric Vaccines|Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M‑M‑R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
1131738|NCT00483548|B3|Baseline|Total|Total of all reporting groups
1131739|NCT00483548|B2|Baseline|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131740|NCT00483548|B1|Baseline|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131741|NCT00483548|P2|Participant Flow|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131742|NCT00483548|P1|Participant Flow|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131743|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131744|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131745|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131746|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131747|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131748|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131873|NCT00483184|E3|Reported Event|3|(Veldona)1000 IU IFNα bid
1131749|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131750|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131751|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131752|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131753|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131754|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131755|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131756|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131757|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131758|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131759|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131760|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131761|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131762|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131763|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131824|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
1131764|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131765|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131766|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131767|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131768|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131769|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131770|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131771|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131772|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131773|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131774|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131775|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131776|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131777|NCT00483548|E2|Reported Event|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131778|NCT00483548|E1|Reported Event|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
1131779|NCT00483496|B1|Baseline|Experimental|Each patient received the 8 test products on the 8 test areas of the randomly allocated grid.
1131780|NCT00483496|P1|Participant Flow|Experimental|Each patient received the 8 test products on the 8 test areas of the randomly allocated grid.
1131781|NCT00483496|O8|Outcome|Vehicle|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
1131782|NCT00483496|O7|Outcome|TiO2Pig|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
1131783|NCT00483496|O6|Outcome|TiO2 Micro|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
1131784|NCT00483496|O5|Outcome|Bisoctrizole|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
1131785|NCT00483496|O4|Outcome|TiO2Pig + TiO2Micro|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
1131786|NCT00483496|O3|Outcome|TiO2 Micro + Bisoctrizole|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
1131787|NCT00483496|O2|Outcome|Ti02Pig + Bisoctrizole|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
1131788|NCT00483496|O1|Outcome|V0096|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
1131789|NCT00483496|E1|Reported Event|Experimental|Each patient received the 8 test products on the 8 test areas of the randomly allocated grid.
1131790|NCT00483405|B1|Baseline|Single Arm Trial|"Single Arm Trial~cetuximab: 250 mg/m2, intravenously, once per week~capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.~oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle"
1131791|NCT00483405|P1|Participant Flow|Single Arm Trial|"Single Arm Trial~cetuximab: 250 mg/m2, intravenously, once per week~capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.~oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle"
1131792|NCT00483405|O1|Outcome|Single Arm Trial|"Single Arm Trial~cetuximab: 250 mg/m2, intravenously, once per week~capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.~oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle"
1131793|NCT00483405|O1|Outcome|Single Arm Trial|"Single Arm Trial~cetuximab: 250 mg/m2, intravenously, once per week~capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.~oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle"
1131794|NCT00483405|O1|Outcome|Single Arm Trial|"Single Arm Trial~cetuximab: 250 mg/m2, intravenously, once per week~capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.~oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle"
1131795|NCT00483405|O1|Outcome|Single Arm Trial|"Single Arm Trial~cetuximab: 250 mg/m2, intravenously, once per week~capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.~oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle"
1131796|NCT00483405|E1|Reported Event|Single Arm Trial|"Single Arm Trial~cetuximab: 250 mg/m2, intravenously, once per week~capecitabine: 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.~oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle"
1131797|NCT00483379|B3|Baseline|Total|Total of all reporting groups
1131798|NCT00483379|B2|Baseline|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
1131799|NCT00483379|B1|Baseline|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
1131800|NCT00483379|P2|Participant Flow|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
1131801|NCT00483379|P1|Participant Flow|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
1131802|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
1131803|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
1131804|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
1131805|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
1131806|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
1131807|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
1131808|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
1131809|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
1131810|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
1131811|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
1131812|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
1131813|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
1131814|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
1131815|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
1131816|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
1131817|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
1131818|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
1131819|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
1131820|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
1131821|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
1131822|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
1131825|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
1131826|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
1131827|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
1131828|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
1131829|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
1131830|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
1131831|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
1131832|NCT00483379|E4|Reported Event|Extension: Alglucosidase Alfa 40 mg/kg Every Other Week|The extension period of the study allowed late-onset participants access to the same treatment they took in the treatment period until the product was commercially available.
1131833|NCT00483379|E3|Reported Event|Extension: Alglucosidase Alfa 20 mg/kg Every Week|The extension period of the study allowed late-onset participants access to the same treatment they took in the treatment period until the product was commercially available.
1131874|NCT00483184|E2|Reported Event|2|(Veldona)500 IU IFNα bid
1131834|NCT00483379|E2|Reported Event|Treatment: Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
1131835|NCT00483379|E1|Reported Event|Treatment: Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
1131843|NCT00483262|B3|Baseline|Total|Total of all reporting groups
1131844|NCT00483262|B2|Baseline|CCI779 and Bortezomib Phase II|CCI779 and Bortezomib Phase II part of this Phase I/II study
1131845|NCT00483262|B1|Baseline|CCI779 and Bortezomib Phase I|CCI779 and Bortezomib Phase I part of this Phase I/II study.
1131846|NCT00483262|P2|Participant Flow|CCI779 and Bortezomib Phase II|CCI779 and Bortezomib, Phase II part of this Phase I/II study
1131847|NCT00483262|P1|Participant Flow|CCI779 and Bortezomib Phase I|CCI779 and Bortezomib, Phase I part of this Phase I/II study
1131848|NCT00483262|O2|Outcome|CCI779 PFS Phase II|Progression-free survival results from the phase II part of the phase I/II CCI779 with velcade study.
1131849|NCT00483262|O1|Outcome|CCI779 PFS Phase I|Progression-free survival results from the phase I part of the phase I/II CCI779 with velcade study.
1131850|NCT00483262|O2|Outcome|CCI779 Response Phase II|Response of PR or better per the Blade criteria in phase II part of this phase I/II study of CCI779 and velcade
1131851|NCT00483262|O1|Outcome|CCI779 Response Phase I|Response of PR or better per the Blade criteria in phase I part of this phase I/II study of CCI779 and velcade
1131852|NCT00483262|O2|Outcome|CCI779 Toxicity Phase II|Toxicity of CCI779 and velcade in the phase II part of this phase I/II study. CTC criteria used
1131853|NCT00483262|O1|Outcome|CCI779 Toxicity Phase I|Toxicity of CCI779 and velcade in the phase I part of this phase I/II study. CTC criteria used.
1131854|NCT00483262|E2|Reported Event|Adverse Events CCI779 and Bortezomib Phase II|Adverse Events of CCI779 and Bortezomib in Phase II part of this Phase I/II study.
1131855|NCT00483262|E1|Reported Event|Adverse Events CCI779 and Bortezomib Phase I|Adverse Events of CCI779 and Bortezomib in the phase I part of this phase I/II study.
1131856|NCT00483223|B1|Baseline|Single Arm|"Cisplatin or carboplatin (1 arm, 2 cohorts)~Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.~carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects."
1131857|NCT00483223|P1|Participant Flow|Cisplatin or Carboplatin|"Cisplatin or carboplatin (1 arm, 2 cohorts)~Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.~carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects."
1131858|NCT00483223|O1|Outcome|Cisplatin or Carboplatin|"Cisplatin or carboplatin (1 arm, 2 cohorts)~Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.~carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects."
1131904|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
1131905|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
1140876|NCT00460239|O3|Outcome|Morphine 30 mg|
1131859|NCT00483223|O1|Outcome|Cisplatin or Carboplatin|"Cisplatin or carboplatin (1 arm, 2 cohorts)~Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.~carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects."
1131860|NCT00483223|O1|Outcome|Cisplatin or Carboplatin|"Cisplatin or carboplatin (1 arm, 2 cohorts)~Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.~carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects."
1131861|NCT00483223|O1|Outcome|Cisplatin or Carboplatin|"Cisplatin or carboplatin (1 arm, 2 cohorts)~Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.~carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects."
1131862|NCT00483223|E1|Reported Event|Cisplatin or Carboplatin|"Cisplatin or carboplatin (1 arm, 2 cohorts)~Cisplatin: Given intravenously on the first day of each 3-week treatment cycle at 75mg/m2. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects.~carboplatin: Given intravenously on the first day of each 3-week treatment cycle at AUC 6. Participants may continue to receive study treatment as long as their disease does not worsen and they do not experience serious side effects."
1131863|NCT00483184|B4|Baseline|Total|Total of all reporting groups
1131864|NCT00483184|B3|Baseline|3|(Veldona)1000 IU IFNα bid
1131865|NCT00483184|B2|Baseline|2|(Veldona)500 IU IFNα bid
1131866|NCT00483184|B1|Baseline|1|(placebo)0 IU IFN alpha
1131867|NCT00483184|P3|Participant Flow|3|(Veldona)1000 IU IFNα bid
1131868|NCT00483184|P2|Participant Flow|2|(Veldona)500 IU IFNα bid
1131869|NCT00483184|P1|Participant Flow|1|(placebo)0 IU IFN alpha
1131870|NCT00483184|O3|Outcome|3|(Veldona)1000 IU IFNα bid
1131871|NCT00483184|O2|Outcome|2|(Veldona)500 IU IFNα bid
1131872|NCT00483184|O1|Outcome|1|(placebo)0 IU IFN alpha
1131877|NCT00483119|B2|Baseline|Group B|"IVIg with cyclophosphamide~cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration"
1131878|NCT00483119|B1|Baseline|Group A|"IVIg alone~intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles"
1131879|NCT00483119|P2|Participant Flow|IVIg With Cyclophosphamide|"IVIg with cyclophosphamide~cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration"
1131880|NCT00483119|P1|Participant Flow|IVIg Alone|"IVIg alone~intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles"
1131881|NCT00483119|O2|Outcome|IVIg With Cyclophosphamide|"IVIg with cyclophosphamide~cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration"
1131882|NCT00483119|O1|Outcome|IVIg Alone|"IVIg alone~intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles"
1131883|NCT00483119|O2|Outcome|IVIg With Cyclophosphamide|"IVIg with cyclophosphamide~cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration"
1131884|NCT00483119|O1|Outcome|IVIg Alone|"IVIg alone~intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles"
1131885|NCT00483119|O2|Outcome|IVIg With Cyclophosphamide|"IVIg with cyclophosphamide~cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration"
1131886|NCT00483119|O1|Outcome|IVIg Alone|"IVIg alone~intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles"
1131887|NCT00483119|O2|Outcome|IVIg With Cyclophosphamide|"IVIg with cyclophosphamide~cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration"
1131888|NCT00483119|O1|Outcome|IVIg Alone|"IVIg alone~intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles"
1131889|NCT00483119|E2|Reported Event|Group B|"IVIg with cyclophosphamide~cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration"
1131890|NCT00483119|E1|Reported Event|Group A|"IVIg alone~intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles"
1131891|NCT00483041|B3|Baseline|Total|Total of all reporting groups
1131892|NCT00483041|B2|Baseline|MEDI528 9 mg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
1131893|NCT00483041|B1|Baseline|PLACEBO|Placebo administered as a single intravenous dose
1131894|NCT00483041|P2|Participant Flow|MEDI528 9 mg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
1131895|NCT00483041|P1|Participant Flow|PLACEBO|Placebo administered as a single intravenous dose
1131896|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
1131897|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
1131898|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
1131899|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
1131900|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
1131901|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
1131902|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
1131903|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
1131906|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
1131907|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
1131908|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
1131909|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
1131910|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
1131911|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
1131912|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
1131913|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
1131914|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
1131915|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
1131916|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
1131917|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
1131918|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
1131919|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
1131920|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
1131921|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
1131922|NCT00483041|E2|Reported Event|MEDI528 9 mg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
1131923|NCT00483041|E1|Reported Event|PLACEBO|Placebo administered as a single intravenous dose
1131924|NCT00483002|B1|Baseline|Varenicline|Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator’s discretion for 12 weeks.
1131925|NCT00483002|P1|Participant Flow|Varenicline|Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator’s discretion for 12 weeks.
1131926|NCT00483002|O1|Outcome|Varenicline|Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator’s discretion for 12 weeks.
1131927|NCT00483002|O1|Outcome|Varenicline|Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator’s discretion for 12 weeks.
1131928|NCT00483002|O1|Outcome|Varenicline|Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator’s discretion for 12 weeks.
1131929|NCT00483002|E1|Reported Event|Varenicline|Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator’s discretion for 12 weeks.
1131930|NCT00482911|B3|Baseline|Total|Total of all reporting groups
1131931|NCT00482911|B2|Baseline|Cohort 2-sunitinib & Cyclophosphamide|2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
1131932|NCT00482911|B1|Baseline|Cohort 1-lenalidomide & Cyclophosphamide|Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
1131933|NCT00482911|P2|Participant Flow|Cohort 2-sunitinib & Cyclophosphamide|2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
1131934|NCT00482911|P1|Participant Flow|Cohort 1-lenalidomide & Cyclophosphamide|Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
1131935|NCT00482911|O2|Outcome|Cohort 2-sunitinib & Cyclophosphamide|2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
1131936|NCT00482911|O1|Outcome|Cohort 1-lenalidomide & Cyclophosphamide|Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
1131937|NCT00482911|O2|Outcome|Cohort 2-sunitinib & Cyclophosphamide|2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
1131938|NCT00482911|O1|Outcome|Cohort 1-lenalidomide & Cyclophosphamide|Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
1131982|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
1131939|NCT00482911|O2|Outcome|Cohort 2-sunitinib & Cyclophosphamide|2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
1131940|NCT00482911|O1|Outcome|Cohort 1-lenalidomide & Cyclophosphamide|Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
1131941|NCT00482911|O2|Outcome|Cohort 2-sunitinib & Cyclophosphamide|2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
1131942|NCT00482911|O1|Outcome|Cohort 1-lenalidomide & Cyclophosphamide|Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
1131943|NCT00482911|O2|Outcome|Cohort 2-sunitinib & Cyclophosphamide|2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
1131944|NCT00482911|O1|Outcome|Cohort 1-lenalidomide & Cyclophosphamide|Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
1131996|NCT00482703|O5|Outcome|Dasatinib 50 mg BID Starting Dose - Imatinib-resistant|Imatinib-resistant participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
1131997|NCT00482703|O4|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
1131945|NCT00482911|E2|Reported Event|Cohort 2-sunitinib & Cyclophosphamide|2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
1131946|NCT00482911|E1|Reported Event|Cohort 1-lenalidomide & Cyclophosphamide|Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
1131947|NCT00482729|B3|Baseline|Total|Total of all reporting groups
1131948|NCT00482729|B2|Baseline|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
1131949|NCT00482729|B1|Baseline|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
1131950|NCT00482729|P2|Participant Flow|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
1131951|NCT00482729|P1|Participant Flow|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
1131952|NCT00482729|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
1131953|NCT00482729|O1|Outcome|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
1131954|NCT00482729|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
1131955|NCT00482729|O1|Outcome|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
1140877|NCT00460239|O2|Outcome|Morphine 15 mg|
1131956|NCT00482729|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
1131957|NCT00482729|O1|Outcome|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
1131958|NCT00482729|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
1131959|NCT00482729|O1|Outcome|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
1131960|NCT00482729|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
1131961|NCT00482729|O1|Outcome|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
1131962|NCT00482729|E2|Reported Event|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
1131963|NCT00482729|E1|Reported Event|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
1131964|NCT00482703|B3|Baseline|Total|Total of all reporting groups
1131965|NCT00482703|B2|Baseline|Dasatinib 50 mg Twice-daily (BID) Starting Dose|Starting dose of 50 mg BID oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.
1131966|NCT00482703|B1|Baseline|Dasatinib 100 mg Once-daily (QD) Starting Dose|Starting dose of 100 mg QD oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.
1131967|NCT00482703|P2|Participant Flow|Dasatinib 50 mg Twice-daily (BID) Starting Dose|Starting dose of 50 mg BID oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.
1131968|NCT00482703|P1|Participant Flow|Dasatinib 100 mg Once-daily (QD) Starting Dose|Starting dose of 100 mg QD oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.
1131969|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
1131970|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
1131971|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
1131972|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
1131973|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
1131974|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
1131975|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
1131976|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
1131977|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
1131978|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
1131979|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
1131980|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
1131981|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
1131983|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
1131984|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
1131985|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
1131986|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
1131987|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
1131988|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
1131989|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
1131990|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
1131991|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
1131992|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
1131993|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
1131994|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
1131995|NCT00482703|O6|Outcome|Dasatinib 50 mg BID Starting Dose - Imatinib-intolerant|Imatinib-intolerant participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
1133737|NCT00477269|O1|Outcome|STI571|STI571
1131998|NCT00482703|O3|Outcome|Dasatinib 100 mg QD Starting Dose - Imatinib-intolerant|Imatinib-intolerant participants treated with a starting Dasatinib (BMS-354825) dose of 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
1131999|NCT00482703|O2|Outcome|Dasatinib 100 mg QD Starting Dose - Imatinib-resistant|Imatinib-resistant participants treated with a starting Dasatinib (BMS-354825) dose of 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
1132000|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
1132001|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
1132002|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
1132003|NCT00482703|O6|Outcome|Dasatinib 50 mg BID Starting Dose - Imatinib-intolerant|Imatinib-intolerant participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
1132004|NCT00482703|O5|Outcome|Dasatinib 50 mg BID Starting Dose - Imatinib-resistant|Imatinib-resistant participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
1132005|NCT00482703|O4|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
1132006|NCT00482703|O3|Outcome|Dasatinib 100 mg QD Starting Dose - Imatinib-intolerant|Imatinib-intolerant participants treated with a starting Dasatinib (BMS-354825) dose of 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
1132007|NCT00482703|O2|Outcome|Dasatinib 100 mg QD Starting Dose - Imatinib-resistant|Imatinib-resistant participants treated with a starting Dasatinib (BMS-354825) dose of 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
1132008|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
1132009|NCT00482703|E3|Reported Event|Total|
1132010|NCT00482703|E2|Reported Event|Dasatinib 50 mg Twice-daily (BID) Starting Dose|Starting dose of 50 mg BID oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.
1132011|NCT00482703|E1|Reported Event|Dasatinib 100 mg Once-daily (QD) Starting Dose|Starting dose of 100 mg QD oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.
1132012|NCT00482625|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.~erlotinib hydrochloride: Given PO~conventional surgery: Undergo pancreatectomy~immunohistochemistry staining method: Correlative studies~protein expression analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1132013|NCT00482625|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.~erlotinib hydrochloride: Given PO~conventional surgery: Undergo pancreatectomy~immunohistochemistry staining method: Correlative studies~protein expression analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1132014|NCT00482625|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.~erlotinib hydrochloride: Given PO~conventional surgery: Undergo pancreatectomy~immunohistochemistry staining method: Correlative studies~protein expression analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1132015|NCT00482625|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.~erlotinib hydrochloride: Given PO~conventional surgery: Undergo pancreatectomy~immunohistochemistry staining method: Correlative studies~protein expression analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1132016|NCT00482625|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.~erlotinib hydrochloride: Given PO~conventional surgery: Undergo pancreatectomy~immunohistochemistry staining method: Correlative studies~protein expression analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1132017|NCT00482625|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.~erlotinib hydrochloride: Given PO~conventional surgery: Undergo pancreatectomy~immunohistochemistry staining method: Correlative studies~protein expression analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1132018|NCT00482625|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.~erlotinib hydrochloride: Given PO~conventional surgery: Undergo pancreatectomy~immunohistochemistry staining method: Correlative studies~protein expression analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1132019|NCT00482625|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.~erlotinib hydrochloride: Given PO~conventional surgery: Undergo pancreatectomy~immunohistochemistry staining method: Correlative studies~protein expression analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1132020|NCT00482625|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.~erlotinib hydrochloride: Given PO~conventional surgery: Undergo pancreatectomy~immunohistochemistry staining method: Correlative studies~protein expression analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1132021|NCT00482612|B5|Baseline|Total|Total of all reporting groups
1132022|NCT00482612|B4|Baseline|Placebo|Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period. No study medication was administered during the Follow-up Period.
1132023|NCT00482612|B3|Baseline|Esmirtazapine 4.5 mg|Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period. No study medication was administered during the Follow-up Period.
1132024|NCT00482612|B2|Baseline|Esmirtazapine 3.0 mg|Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period. No study medication was administered during the Follow-up Period.
1132025|NCT00482612|B1|Baseline|Esmirtazapine 1.5 mg|Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period. No study medication was administered during the Follow-up Period.
1132026|NCT00482612|P4|Participant Flow|Placebo|Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period. Participants were followed for safety during a Follow-up Period, in which no study medication was administered.
1132027|NCT00482612|P3|Participant Flow|Esmirtazapine 4.5 mg|Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period. Participants were followed for safety during a Follow-up Period, in which no study medication was administered.
1132028|NCT00482612|P2|Participant Flow|Esmirtazapine 3.0 mg|Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period. Participants were followed for safety during a Follow-up Period, in which no study medication was administered.
1132029|NCT00482612|P1|Participant Flow|Esmirtazapine 1.5 mg|Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period. Participants were followed for safety during a Follow-up Period, in which no study medication was administered.
1132030|NCT00482612|O4|Outcome|Placebo|Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period.
1132031|NCT00482612|O3|Outcome|Esmirtazapine 4.5 mg|Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
1132032|NCT00482612|O2|Outcome|Esmirtazapine 3.0 mg|Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period.
1132033|NCT00482612|O1|Outcome|Esmirtazapine 1.5 mg|Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
1132034|NCT00482612|O4|Outcome|Placebo|Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period.
1132035|NCT00482612|O3|Outcome|Esmirtazapine 4.5 mg|Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
1132036|NCT00482612|O2|Outcome|Esmirtazapine 3.0 mg|Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period.
1132037|NCT00482612|O1|Outcome|Esmirtazapine 1.5 mg|Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
1132038|NCT00482612|O4|Outcome|Placebo|Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period.
1132039|NCT00482612|O3|Outcome|Esmirtazapine 4.5 mg|Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
1132040|NCT00482612|O2|Outcome|Esmirtazapine 3.0 mg|Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period.
1132041|NCT00482612|O1|Outcome|Esmirtazapine 1.5 mg|Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
1132042|NCT00482612|O4|Outcome|Placebo|Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period.
1132043|NCT00482612|O3|Outcome|Esmirtazapine 4.5 mg|Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
1132044|NCT00482612|O2|Outcome|Esmirtazapine 3.0 mg|Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period.
1132045|NCT00482612|O1|Outcome|Esmirtazapine 1.5 mg|Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
1132046|NCT00482612|E8|Reported Event|Placebo Follow-up|After receiving placebo in the In-Treatment Period, participants were followed for safety during a Follow-up Period in which no study medication was administered.
1132047|NCT00482612|E7|Reported Event|Esmirtazapine 4.5 mg Follow-up|After receiving 4.5 mg esmirtazipine in the In-Treatment Period, participants were followed for safety during a Follow-up Period in which no study medication was administered.
1132048|NCT00482612|E6|Reported Event|Esmirtazapine 3.0 mg Folow-up|After receiving 3.0 mg esmirtazipine in the In-Treatment Period, participants were followed for safety during a Follow-up Period in which no study medication was administered.
1132049|NCT00482612|E5|Reported Event|Esmirtazapine 1.5 mg Follow-up|After receiving 1.5 mg esmirtazipine in the In-Treatment Period, participants were followed for safety during a Follow-up Period in which no study medication was administered.
1132050|NCT00482612|E4|Reported Event|Placebo In-treatment|Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period.
1132051|NCT00482612|E3|Reported Event|Esmirtazapine 4.5 mg In-treatment|Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
1132052|NCT00482612|E2|Reported Event|Esmirtazapine 3.0 mg In-Treatment|Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period.
1132053|NCT00482612|E1|Reported Event|Esmirtazapine 1.5 mg In-treatment|Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
1132054|NCT00482547|B3|Baseline|Total|Total of all reporting groups
1132055|NCT00482547|B2|Baseline|Silicone-coated Catheter|silicone elastomer-coated latex catheter
1132056|NCT00482547|B1|Baseline|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
1132057|NCT00482547|P2|Participant Flow|Silicone-coated Catheter|silicone elastomer-coated latex catheter
1132058|NCT00482547|P1|Participant Flow|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
1132059|NCT00482547|O2|Outcome|Silicone-coated Catheter|silicone elastomer-coated latex catheter
1132060|NCT00482547|O1|Outcome|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
1132061|NCT00482547|O2|Outcome|Silicone-coated Catheter|silicone elastomer-coated latex catheter
1132062|NCT00482547|O1|Outcome|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
1132063|NCT00482547|O2|Outcome|Silicone-coated Catheter|silicone elastomer-coated latex catheter
1132064|NCT00482547|O1|Outcome|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
1132065|NCT00482547|O2|Outcome|Silicone-coated Catheter|silicone elastomer-coated latex catheter
1132066|NCT00482547|O1|Outcome|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
1132067|NCT00482547|O2|Outcome|Silicone-coated Catheter|silicone elastomer-coated latex catheter
1132068|NCT00482547|O1|Outcome|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
1132069|NCT00482547|O2|Outcome|Silicone-coated Catheter|silicone elastomer-coated latex catheter
1132070|NCT00482547|O1|Outcome|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
1132071|NCT00482547|O2|Outcome|Silicone-coated Catheter|silicone elastomer-coated latex catheter
1132072|NCT00482547|O1|Outcome|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
1132073|NCT00482547|O2|Outcome|Silicone-coated Catheter|silicone elastomer-coated latex catheter
1132074|NCT00482547|O1|Outcome|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
1132075|NCT00482547|E2|Reported Event|Silicone-coated Catheter|silicone elastomer-coated latex catheter
1132076|NCT00482547|E1|Reported Event|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
1132077|NCT00480636|B1|Baseline|Dalteparin|Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
1132078|NCT00480636|P1|Participant Flow|Dalteparin|Dalteparin 200 International Units per kilogram (IU/kg) total body weight subcutaneously (SC) once daily (QD) for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
1132079|NCT00480636|O1|Outcome|Dalteparin|Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
1132080|NCT00480636|O1|Outcome|Dalteparin|Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
1132081|NCT00480636|O1|Outcome|Dalteparin|Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
1132082|NCT00480636|O1|Outcome|Dalteparin|Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
1132083|NCT00480636|O1|Outcome|Dalteparin|Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
1132084|NCT00480636|E1|Reported Event|Dalteparin|Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
1132085|NCT00482391|B1|Baseline|AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB|The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate.
1132086|NCT00482391|P1|Participant Flow|AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB|The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate.
1132087|NCT00482391|O1|Outcome|Dose-dense Adjuvant/ Neoadjuvant Chemotherapy Regimen|
1132088|NCT00482391|O1|Outcome|AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB|The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate.
1132089|NCT00482391|E1|Reported Event|AC, PACLITAXEL , TRASTUZUMAB & LAPATINIB|The regimen consists of AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 4 with pegfilgrastim, followed by weekly paclitaxel (80 mg/m2) x 12 + trastuzumab (H) + lapatinib (L). Pegfilgrastim 6mg is given subcutaneously (SQ) on day # 2 of each AC. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion. Trastuzumab will be administered weekly starting with paclitaxel treatment # 1. Near the completion of all chemotherapy, patients may receive trastuzumab on a q 3-weekly schedule, starting as early as with paclitaxel cycle # 12. The total duration of trastuzumab from beginning to end is 52 weeks. Lapatinib will be given orally at 1000 mg daily, starting with trastuzumab for a total duration of 52 weeks. Hormonal therapy such as tamoxifen or an aromatase inhibitor will be given to patients with hormone receptor positive disease at the physician's discretion. Radiation therapy to the breast or chest is recommended to patients as appropriate.
1132090|NCT00482274|B1|Baseline|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
1132091|NCT00482274|P1|Participant Flow|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
1132092|NCT00482274|O1|Outcome|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
1132093|NCT00482274|O1|Outcome|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
1132094|NCT00482274|O1|Outcome|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
1132095|NCT00482274|O1|Outcome|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
1132096|NCT00482274|O1|Outcome|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
1132097|NCT00482274|E1|Reported Event|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
1132098|NCT00482170|B3|Baseline|Total|Total of all reporting groups
1132099|NCT00482170|B2|Baseline|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132100|NCT00482170|B1|Baseline|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132101|NCT00482170|P2|Participant Flow|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg prefilled syringe (PFS) s.c. twice-weekly for 12 weeks.
1132102|NCT00482170|P1|Participant Flow|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 milligram (mg) auto-injector (AI) subcutaneously (s.c.) twice-weekly for 12 weeks.
1132103|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132104|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132105|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132106|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132107|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132108|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132109|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132110|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132111|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132112|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132113|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132114|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132115|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132116|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132117|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132118|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132119|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132120|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1140878|NCT00460239|O1|Outcome|Placebo 0 mg|
1132121|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132122|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132123|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132124|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132125|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132126|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132127|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132128|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132129|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132130|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132131|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132132|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132133|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132134|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132135|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132136|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132137|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132138|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132139|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132140|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132141|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132142|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132143|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132144|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132145|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132146|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132147|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132148|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132149|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132150|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132151|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132152|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132153|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132154|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132155|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132156|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132157|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132158|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132159|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132160|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132161|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132162|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132163|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132164|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132165|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132166|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132167|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132168|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132169|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132170|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132171|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132172|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132173|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1140879|NCT00460239|O8|Outcome|Buprenorphine 60 mg|
1132174|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132175|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132176|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132177|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132178|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132179|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132180|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132181|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132182|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132183|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132184|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132185|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132186|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132187|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132188|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132189|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132190|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132191|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132192|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132193|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132194|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132195|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132196|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132197|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132198|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132199|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132200|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132201|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132202|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132203|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132204|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132205|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132206|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132207|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132208|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132209|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132210|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132211|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132212|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132213|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132214|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132215|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132216|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132217|NCT00482170|E2|Reported Event|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
1132218|NCT00482170|E1|Reported Event|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
1132219|NCT00482014|B5|Baseline|Total|Total of all reporting groups
1132220|NCT00482014|B4|Baseline|Pemetrexed + Cisplatin (Study Phase 2)|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
1132221|NCT00482014|B3|Baseline|Pemetrexed + Carboplatin (Study Phase 2)|"500 mg/m² pemetrexed every 21 days for 3 cycles + Carboplatin dosed at AUC 5 mg/mL*min every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
1132435|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
1132436|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
1132222|NCT00482014|B2|Baseline|Pemetrexed + Cisplatin (Study Phase 1)|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 30 mg/m² or 75 mg/m² on Days 1, 8, 22, 29, 43 + radiation therapy 74 Gy total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
1132223|NCT00482014|B1|Baseline|Pemetrexed + Carboplatin (Study Phase 1)|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min) on Days 1, 8, 22, 29, 43 + radiation therapy (RT) 74 Grays (Gy) total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
1132224|NCT00482014|P4|Participant Flow|Pemetrexed + Cisplatin (Study Phase 2)|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
1132225|NCT00482014|P3|Participant Flow|Pemetrexed + Carboplatin (Study Phase 2)|"500 mg/m² pemetrexed every 21 days for 3 cycles + Carboplatin dosed at AUC 5 mg/mL*min every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
1132226|NCT00482014|P2|Participant Flow|Pemetrexed + Cisplatin (Study Phase 1)|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 30 mg/m² or 75 mg/m² on Days 1, 8, 22, 29, 43 + radiation therapy 74 Gy total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
1132227|NCT00482014|P1|Participant Flow|Pemetrexed + Carboplatin (Study Phase 1)|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min) on Days 1, 8, 22, 29, 43 + radiation therapy (RT) 74 Grays (Gy) total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
1132228|NCT00482014|O2|Outcome|Pemetrexed + Cisplatin Treatment Group|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
1132229|NCT00482014|O1|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 5 milligram/milliliter*minute (mg/mL*min) every 21 days for 3 cycles + radiation therapy (RT) 64-68 Gray (Gy) total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
1132230|NCT00482014|O2|Outcome|Pemetrexed + Cisplatin Treatment Group|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
1132231|NCT00482014|O1|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 5 milligram/milliliter*minute (mg/mL*min) every 21 days for 3 cycles + radiation therapy (RT) 64-68 (Gray) Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
1132232|NCT00482014|O2|Outcome|Pemetrexed + Cisplatin Treatment Group|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
1132233|NCT00482014|O1|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 5 milligram/milliliter*minute (mg/mL*min) every 21 days for 3 cycles + radiation therapy (RT) 64-68 Gray (Gy) total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
1132234|NCT00482014|O2|Outcome|Pemetrexed + Cisplatin Treatment Group|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
1132235|NCT00482014|O1|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 5 milligram/milliliter*minute (mg/mL*min) every 21 days for 3 cycles + radiation therapy (RT) 64-68 (Gray) Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
1132236|NCT00482014|O2|Outcome|Pemetrexed + Cisplatin Treatment Group|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
1132254|NCT00481988|O1|Outcome|Transcranial Direct Current Stimulation|one group of patients will receive active transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation, whereas the second group of patients will receive two weeks of sham transcranial direct current stimulation followed by two weeks of active transcranial direct current stimulation
1132237|NCT00482014|O1|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 5 milligram/milliliter*minute (mg/mL*min) every 21 days for 3 cycles + radiation therapy (RT) 64-68 (Gray) Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
1132238|NCT00482014|O2|Outcome|Pemetrexed + Cisplatin Treatment|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 30 mg/m² or 75 mg/m² on Days 1, 8, 22, 29, 43 + radiation therapy 74 Gy total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
1132239|NCT00482014|O1|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min) on Days 1, 8, 22, 29, 43 + radiation therapy (RT) 74 Grays (Gy) total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
1132240|NCT00482014|O2|Outcome|Pemetrexed + Cisplatin Treatment|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 30 mg/m² or 75 mg/m² on Days 1, 8, 22, 29, 43 + radiation therapy 74 Gy total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
1132241|NCT00482014|O1|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min) on Days 1, 8, 22, 29, 43 + radiation therapy (RT) 74 Grays (Gy) total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
1132242|NCT00482014|O1|Outcome|Pemetrexed + Cisplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 30 mg/m² or 75 mg/m² on Days 1, 8, 22, 29, 43 + radiation therapy 74 Gy total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
1132263|NCT00481871|B2|Baseline|Phase 1 - Group B|Phase 1 Treatment Group B had pralatrexate followed the next day by gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine. The starting dose was 10 mg/m2 of pralatrexate and 300 mg/m2 of gemcitabine.
1132243|NCT00482014|O1|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min) on Days 1, 8, 22, 29, 43 + radiation therapy (RT) 74 Grays (Gy) total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
1132244|NCT00482014|E4|Reported Event|Phase 2: Pemetrexed + Cisplatin|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
1132245|NCT00482014|E3|Reported Event|Phase 2: Pemetrexed + Carboplatin|"500 mg/m² pemetrexed every 21 days for 3 cycles + Carboplatin dosed at AUC 5 mg/mL*min every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
1132246|NCT00482014|E2|Reported Event|Phase 1: Pemetrexed + Cisplatin|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 30 mg/m² or 75 mg/m² on Days 1, 8, 22, 29, 43 + radiation therapy 74 Grays (Gy) total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
1132247|NCT00482014|E1|Reported Event|Phase 1: Pemetrexed + Carboplatin|"500 milligrams/meter squared (mg/m²) pemetrexed (pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min) on Days 1, 8, 22, 29, 43 + radiation therapy (RT) 74 Grays (Gy) total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
1132248|NCT00481988|B3|Baseline|Total|Total of all reporting groups
1132249|NCT00481988|B2|Baseline|Sham tDCS|the constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.
1132250|NCT00481988|B1|Baseline|Transcranial Direct Current Stimulation|one group of patients will receive active transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation, whereas the second group of patients will receive two weeks of sham transcranial direct current stimulation followed by two weeks of active transcranial direct current stimulation
1132251|NCT00481988|P2|Participant Flow|Sham Iomed II Phoresor Transcranial Direct Current Stimulation|The sham group receives sham stimulation for the first two weeks of the study followed by active treatment in the second two weeks. To mimic the sensation of active treatment and maintain the blind of the study, in the sham arm the Iomed II Phoresor constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.
1132252|NCT00481988|P1|Participant Flow|Iomed II Phoresor Transcranial Direct Current Stimulation|The active group of patients will receive active Iomed II Phoresor transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation.
1132253|NCT00481988|O2|Outcome|Sham tDCS|the constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.
1132428|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
1132429|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
1132255|NCT00481988|O2|Outcome|Sham tDCS|the constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.
1132256|NCT00481988|O1|Outcome|Transcranial Direct Current Stimulation|one group of patients will receive active transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation, whereas the second group of patients will receive two weeks of sham transcranial direct current stimulation followed by two weeks of active transcranial direct current stimulation
1132257|NCT00481988|E2|Reported Event|Sham tDCS|the constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.
1132258|NCT00481988|E1|Reported Event|Transcranial Direct Current Stimulation|one group of patients will receive active transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation, whereas the second group of patients will receive two weeks of sham transcranial direct current stimulation followed by two weeks of active transcranial direct current stimulation
1132259|NCT00481871|B6|Baseline|Total|Total of all reporting groups
1132260|NCT00481871|B5|Baseline|Phase 2 - Group C|Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
1132261|NCT00481871|B4|Baseline|Phase 2 - Group B|Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
1132262|NCT00481871|B3|Baseline|Phase 1 - Group C|Phase 1 Treatment Group C had pralatrexate followed 1 hour later by gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine. The starting dose was 10 mg/m2 of pralatrexate and 300 mg/m2 of gemcitabine.
1132350|NCT00481676|E1|Reported Event|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
1132264|NCT00481871|B1|Baseline|Phase 1 - Group A|Phase 1 Treatment Group A had pralatrexate and gemcitabine administered on sequential days every week for 3 weeks followed by 1 week of rest (a 4 week cycle). The starting dose was 15 mg/m2 of pralatrexate and 400 mg/m2 of gemcitabine.
1132265|NCT00481871|P5|Participant Flow|Phase 2 Group C|Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
1132266|NCT00481871|P4|Participant Flow|Phase 2 Group B|Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
1132267|NCT00481871|P3|Participant Flow|Phase 1 Group C - Dose Finding|Phase 1 Treatment Group C had pralatrexate followed 1 hour later by gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine. The starting dose was 10 mg/m2 of pralatrexate and 300 mg/m2 of gemcitabine.
1132268|NCT00481871|P2|Participant Flow|Phase 1 Group B - Dose Finding|Phase 1 Treatment Group B had pralatrexate followed the next day by gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine. The starting dose was 10 mg/m2 of pralatrexate and 300 mg/m2 of gemcitabine.
1132269|NCT00481871|P1|Participant Flow|Phase 1 Group A - Dose Finding|Phase 1 Treatment Group A had pralatrexate and gemcitabine administered on sequential days every week for 3 weeks followed by 1 week of rest (a 4 week cycle). The starting dose was 15 mg/m2 of pralatrexate and 400 mg/m2 of gemcitabine.
1132270|NCT00481871|O3|Outcome|Phase 2 - Group C|Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
1132271|NCT00481871|O2|Outcome|Phase 2 - Group B|Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
1132272|NCT00481871|O1|Outcome|Phase 1|Includes the Phase 1 dose-finding groups A, B, and C
1132273|NCT00481871|O3|Outcome|Phase 2 - Group C|Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
1132274|NCT00481871|O2|Outcome|Phase 2 - Group B|Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
1132275|NCT00481871|O1|Outcome|Phase 1|Includes the Phase 1 dose-finding groups A, B, and C
1132276|NCT00481871|O3|Outcome|Phase 2 - Group C|Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
1132277|NCT00481871|O2|Outcome|Phase 2 - Group B|Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
1132278|NCT00481871|O1|Outcome|Phase 1|Includes the Phase 1 dose-finding groups A, B, and C
1132430|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
1132431|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
1132279|NCT00481871|E3|Reported Event|Phase 2 - Group C|Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
1132280|NCT00481871|E2|Reported Event|Phase 2 - Group B|Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
1132281|NCT00481871|E1|Reported Event|Phase 1|Patients that received at least one dose of pralatrexate in the Phase 1 portion of the study
1132282|NCT00481845|B3|Baseline|Total|Total of all reporting groups
1132283|NCT00481845|B2|Baseline|Anastrozole|Anastrozole as neoadjuvant therapy
1132284|NCT00481845|B1|Baseline|Vandetanib + Anastrozole|Vandetanib and Anastrozole as neoadjuvant therapy
1132285|NCT00481845|P2|Participant Flow|Anastrozole|Anastrozole as neoadjuvant therapy
1132286|NCT00481845|P1|Participant Flow|Vandetanib + Anastrozole|Vandetanib and Anastrozole as neoadjuvant therapy
1132287|NCT00481845|O2|Outcome|Anastrozole|Anastrozole as neoadjuvant therapy
1132288|NCT00481845|O1|Outcome|Vandetanib + Anastrozole|Vandetanib and Anastrozole as neoadjuvant therapy
1132289|NCT00481845|O2|Outcome|Anastrozole|Anastrozole as neoadjuvant therapy
1132290|NCT00481845|O1|Outcome|Vandetanib + Anastrozole|Vandetanib and Anastrozole as neoadjuvant therapy
1132291|NCT00481845|E2|Reported Event|Anastrozole|Anastrozole as neoadjuvant therapy
1132292|NCT00481845|E1|Reported Event|Vandetanib + Anastrozole|Vandetanib and Anastrozole as neoadjuvant therapy
1132293|NCT00481767|B3|Baseline|Total|Total of all reporting groups
1132294|NCT00481767|B2|Baseline|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
1132295|NCT00481767|B1|Baseline|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
1132296|NCT00481767|P2|Participant Flow|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
1132297|NCT00481767|P1|Participant Flow|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
1132298|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
1132299|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
1132300|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
1132301|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
1132302|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
1132303|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
1132304|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
1132305|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
1132306|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
1132307|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
1132308|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
1132309|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
1132310|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
1132311|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
1132312|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
1132313|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
1132314|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
1132315|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
1132316|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
1132317|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
1132318|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
1132319|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
1132320|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
1132321|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
1132322|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
1132323|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
1132324|NCT00481767|E2|Reported Event|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
1132325|NCT00481767|E1|Reported Event|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
1132326|NCT00481676|B3|Baseline|Total|Total of all reporting groups
1132327|NCT00481676|B2|Baseline|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
1132328|NCT00481676|B1|Baseline|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
1132329|NCT00481676|P2|Participant Flow|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
1132330|NCT00481676|P1|Participant Flow|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
1132331|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
1132332|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
1132333|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
1132334|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
1132335|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
1132336|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
1132337|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
1132338|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
1132339|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
1132340|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
1132341|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
1132342|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
1132343|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
1132344|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
1132345|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
1132346|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
1132347|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
1132348|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
1132349|NCT00481676|E2|Reported Event|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
1132352|NCT00480532|B4|Baseline|Subantibmicrobial Dose Doxy|Doxycycline 40mg (sustained release) once daily for 84 days
1132353|NCT00480532|B3|Baseline|Placebo (Prevention)|Placebo for prevention portion of the study
1132354|NCT00480532|B2|Baseline|Doxy (7 Day Treatment Arm)|Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
1132355|NCT00480532|B1|Baseline|Placebo (Treatment)|Placebo (for treatment portion of the study)
1132356|NCT00480532|P4|Participant Flow|Subantibmicrobial Dose Doxy|Doxycycline 40mg (sustained release) once daily for 84 days
1132357|NCT00480532|P3|Participant Flow|Placebo (Prevention)|Placebo for prevention portion of the study
1132358|NCT00480532|P2|Participant Flow|Doxy (7 Day Treatment Arm)|Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
1132359|NCT00480532|P1|Participant Flow|Placebo (Treatment)|Placebo (for treatment portion of the study)
1132360|NCT00480532|O4|Outcome|Subantibmicrobial Dose Doxy|Doxycycline 40mg (sustained release) once daily for 84 days
1132361|NCT00480532|O3|Outcome|Placebo (Prevention)|Placebo for prevention portion of the study
1132362|NCT00480532|O2|Outcome|Doxy (7 Day Treatment Arm)|Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
1132363|NCT00480532|O1|Outcome|Placebo (Treatment)|Placebo (for treatment portion of the study)
1132364|NCT00480532|O4|Outcome|Subantibmicrobial Dose Doxy|Doxycycline 40mg (sustained release) once daily for 84 days
1132365|NCT00480532|O3|Outcome|Placebo (Prevention)|Placebo for prevention portion of the study
1132366|NCT00480532|O2|Outcome|Doxy (7 Day Treatment Arm)|Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
1132367|NCT00480532|O1|Outcome|Placebo (Treatment)|Placebo (for treatment portion of the study)
1132368|NCT00480532|O4|Outcome|Subantibmicrobial Dose Doxy|Doxycycline 40mg (sustained release) once daily for 84 days
1132369|NCT00480532|O3|Outcome|Placebo (Prevention)|Placebo for prevention portion of the study
1132370|NCT00480532|O2|Outcome|Doxy (7 Day Treatment Arm)|Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
1132371|NCT00480532|O1|Outcome|Placebo (Treatment)|Placebo (for treatment portion of the study)
1132372|NCT00480532|E4|Reported Event|Subantibmicrobial Dose Doxy|Doxycycline 40mg (sustained release) once daily for 84 days
1132373|NCT00480532|E3|Reported Event|Placebo (Prevention)|Placebo for prevention portion of the study
1132374|NCT00480532|E2|Reported Event|Doxy (7 Day Treatment Arm)|Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
1132375|NCT00480532|E1|Reported Event|Placebo (Treatment)|Placebo (for treatment portion of the study)
1132376|NCT00480493|B3|Baseline|Total|Total of all reporting groups
1132377|NCT00480493|B2|Baseline|Control Arm|Parent in this group receives parent contact phone number that they can call for parent support
1132378|NCT00480493|B1|Baseline|Parent Mentor Contact|Parent mentor provides face-to-face, phone and/or e-mail social support
1132379|NCT00480493|P2|Participant Flow|Control Arm|Parent in this group receives parent contact phone number that they can call for parent support
1132380|NCT00480493|P1|Participant Flow|Parent Mentor Contact|Parent mentor provides face-to-face, phone and/or e-mail social support
1132381|NCT00480493|O2|Outcome|Parent Mentor Experimental Arm|
1132382|NCT00480493|O1|Outcome|Parent Contact Control Arm|
1132383|NCT00480493|O2|Outcome|Parent Mentor Experimental Arm|
1132384|NCT00480493|O1|Outcome|Parent Contact Control Arm|
1132432|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
1132385|NCT00480493|O2|Outcome|Parent Mentor Experimental Arm|Parent mentor experimental arm had an assigned experienced parent raising a child with type 1 diabetes. The experienced parent mentor contacted the parent and negotiated the intervention dose, depending on need.
1132386|NCT00480493|O1|Outcome|Parent Contact Control Arm|Parent contact control arm had a phone number only to call an experienced parent raising a child with type 1 diabetes to discuss support. The experienced parent contact did not initiate the contact.
1132387|NCT00480493|E2|Reported Event|Control Arm|Parent in this group receives parent contact phone number that they can call for parent support
1132388|NCT00480493|E1|Reported Event|Parent Mentor Contact|Parent mentor provides face-to-face, phone and/or e-mail social support
1132389|NCT00481507|B3|Baseline|Total|Total of all reporting groups
1132390|NCT00481507|B2|Baseline|Kefir|150mL per day, administered orally for 10 consecutive days. Active kefir contained probiotics Lactococcus lactis, Lactococcus plantarum, Lactococcus rhamnosus, Lactococcus casei, Lactococcus lactis subspecies diacetylactis, Leuconostoc cremoris, Bifidobacterium longum, Bifidobacterium breve, Lactobacillus acidophilus, and 1 yeast, Saccharomyces florentinus.
1132391|NCT00481507|B1|Baseline|Placebo|150mL per day, administered orally for 10 consecutive days. Placebo was heat-treated to kill all cultures.
1132392|NCT00481507|P2|Participant Flow|Kefir|150mL per day, administered orally for 10 consecutive days. Active kefir contained probiotics Lactococcus lactis, Lactococcus plantarum, Lactococcus rhamnosus, Lactococcus casei, Lactococcus lactis subspecies diacetylactis, Leuconostoc cremoris, Bifidobacterium longum, Bifidobacterium breve, Lactobacillus acidophilus, and 1 yeast, Saccharomyces florentinus.
1132393|NCT00481507|P1|Participant Flow|Placebo|150mL per day, administered orally for 10 consecutive days. Placebo was heat-treated to kill all cultures.
1132394|NCT00481507|O2|Outcome|Kefir|150mL per day, administered orally for 10 consecutive days. Active kefir contained probiotics Lactococcus lactis, Lactococcus plantarum, Lactococcus rhamnosus, Lactococcus casei, Lactococcus lactis subspecies diacetylactis, Leuconostoc cremoris, Bifidobacterium longum, Bifidobacterium breve, Lactobacillus acidophilus, and 1 yeast, Saccharomyces florentinus.
1132395|NCT00481507|O1|Outcome|Placebo|150mL per day, administered orally for 10 consecutive days. Placebo was heat-treated to kill all cultures.
1132396|NCT00481507|E2|Reported Event|Kefir|150mL per day, administered orally for 10 consecutive days. Active kefir contained probiotics Lactococcus lactis, Lactococcus plantarum, Lactococcus rhamnosus, Lactococcus casei, Lactococcus lactis subspecies diacetylactis, Leuconostoc cremoris, Bifidobacterium longum, Bifidobacterium breve, Lactobacillus acidophilus, and 1 yeast, Saccharomyces florentinus.
1132397|NCT00481507|E1|Reported Event|Placebo|150mL per day, administered orally for 10 consecutive days. Placebo was heat-treated to kill all cultures.
1132398|NCT00481351|B3|Baseline|Total|Total of all reporting groups
1132399|NCT00481351|B2|Baseline|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
1132400|NCT00481351|B1|Baseline|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
1132401|NCT00481351|P2|Participant Flow|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
1132402|NCT00481351|P1|Participant Flow|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
1132403|NCT00481351|O2|Outcome|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
1132404|NCT00481351|O1|Outcome|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
1132405|NCT00481351|O2|Outcome|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
1132406|NCT00481351|O1|Outcome|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
1132407|NCT00481351|O2|Outcome|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
1132408|NCT00481351|O1|Outcome|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
1132409|NCT00481351|O2|Outcome|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
1132410|NCT00481351|O1|Outcome|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
1132411|NCT00481351|O2|Outcome|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
1132412|NCT00481351|O1|Outcome|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
1132413|NCT00481351|E2|Reported Event|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
1132414|NCT00481351|E1|Reported Event|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
1132415|NCT00481247|B3|Baseline|Total|Total of all reporting groups
1132416|NCT00481247|B2|Baseline|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
1132417|NCT00481247|B1|Baseline|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
1132418|NCT00481247|P2|Participant Flow|Imatinib|Tablets, oral, imatinib 400mg once daily (QD)
1132419|NCT00481247|P1|Participant Flow|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
1132420|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
1132421|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
1132422|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
1132423|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
1132424|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
1132425|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
1132426|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
1132427|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
1132437|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
1132438|NCT00481247|E2|Reported Event|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
1132439|NCT00481247|E1|Reported Event|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
1132440|NCT00481195|B3|Baseline|Total|Total of all reporting groups
1132441|NCT00481195|B2|Baseline|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132442|NCT00481195|B1|Baseline|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132443|NCT00481195|P2|Participant Flow|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132566|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132567|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132444|NCT00481195|P1|Participant Flow|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132445|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132446|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132447|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132448|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132449|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132450|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132451|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132452|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132568|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132569|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1133738|NCT00477269|O2|Outcome|Placebo|Placebo
1132453|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132454|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132455|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132456|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132457|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132458|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132543|NCT00481065|B6|Baseline|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132544|NCT00481065|B5|Baseline|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
1132764|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
1132459|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132460|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132470|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132461|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132462|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132463|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132464|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132465|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132466|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132467|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132545|NCT00481065|B4|Baseline|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132546|NCT00481065|B3|Baseline|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132468|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132469|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132471|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132472|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132473|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132474|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132475|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132476|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132547|NCT00481065|B2|Baseline|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132762|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
1132477|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132478|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132488|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132479|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132480|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132481|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132482|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132483|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132484|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132485|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132548|NCT00481065|B1|Baseline|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132848|NCT00479882|E8|Reported Event|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
1132486|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132487|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132489|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132490|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132491|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132492|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132493|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132494|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132549|NCT00481065|P8|Participant Flow|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132550|NCT00481065|P7|Participant Flow|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132992|NCT00479401|B3|Baseline|Placebo|Placebo to PPX ER once and to PPX IR three times a day
1132495|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132496|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132506|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132497|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132498|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132499|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132500|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132501|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132502|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132503|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132551|NCT00481065|P6|Participant Flow|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132552|NCT00481065|P5|Participant Flow|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
1132504|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132505|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132507|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132508|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132509|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132510|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132511|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132512|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132553|NCT00481065|P4|Participant Flow|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132554|NCT00481065|P3|Participant Flow|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132513|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132514|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132524|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132515|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132516|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132517|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132518|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132519|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132520|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132521|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132555|NCT00481065|P2|Participant Flow|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132993|NCT00479401|B2|Baseline|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
1132522|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132523|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132525|NCT00481195|E2|Reported Event|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
1132526|NCT00481195|E1|Reported Event|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
1132527|NCT00481078|B3|Baseline|Total|Total of all reporting groups
1132528|NCT00481078|B2|Baseline|Arm 2|Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
1132529|NCT00481078|B1|Baseline|Arm 1|Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.
1132530|NCT00481078|P2|Participant Flow|Arm II (Placebo, Paclitaxel, Carboplatin)|Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
1132531|NCT00481078|P1|Participant Flow|Arm I (Vorinostat, Paclitaxel, Carboplatin)|Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.
1132532|NCT00481078|O2|Outcome|Arm II (Placebo, Paclitaxel, Carboplatin)|Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
1132533|NCT00481078|O1|Outcome|Arm I (Vorinostat, Paclitaxel, Carboplatin)|Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.
1132534|NCT00481078|O2|Outcome|Arm II (Placebo, Paclitaxel, Carboplatin)|Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
1132535|NCT00481078|O1|Outcome|Arm I (Vorinostat, Paclitaxel, Carboplatin)|Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.
1132536|NCT00481078|O2|Outcome|Arm II (Placebo, Paclitaxel, Carboplatin)|Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
1132537|NCT00481078|O1|Outcome|Arm I (Vorinostat, Paclitaxel, Carboplatin)|Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.
1132538|NCT00481078|E2|Reported Event|Arm II (Placebo, Paclitaxel, Carboplatin)|Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
1132539|NCT00481078|E1|Reported Event|Arm I (Vorinostat, Paclitaxel, Carboplatin)|Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.
1132540|NCT00481065|B9|Baseline|Total|Total of all reporting groups
1132541|NCT00481065|B8|Baseline|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132542|NCT00481065|B7|Baseline|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1133210|NCT00478569|O2|Outcome|6 Months|
1132556|NCT00481065|P1|Participant Flow|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132557|NCT00481065|O2|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
1132558|NCT00481065|O1|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132559|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132560|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132561|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132562|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
1132563|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132564|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132565|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132570|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
1132571|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132572|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132573|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132574|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132575|NCT00481065|O2|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
1132576|NCT00481065|O1|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132577|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132578|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132579|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132580|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
1132581|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132582|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132583|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132584|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132585|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132586|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132587|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132588|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
1132589|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132590|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132591|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132592|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132593|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132594|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132595|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132596|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
1132597|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132598|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132599|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132600|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132601|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132602|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132603|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132604|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
1132605|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132606|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132607|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132608|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132609|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132610|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132611|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132612|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
1132613|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132614|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132615|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132616|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132617|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132618|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132619|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132620|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
1132621|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132622|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132623|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1133211|NCT00478569|O1|Outcome|3 Months|
1132624|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132625|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132626|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132627|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132628|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
1132629|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132630|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132631|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132632|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132633|NCT00481065|E8|Reported Event|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132634|NCT00481065|E7|Reported Event|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132635|NCT00481065|E6|Reported Event|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132636|NCT00481065|E5|Reported Event|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
1132637|NCT00481065|E4|Reported Event|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132677|NCT00480740|B4|Baseline|Total|Total of all reporting groups
1132638|NCT00481065|E3|Reported Event|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132639|NCT00481065|E2|Reported Event|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132640|NCT00481065|E1|Reported Event|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
1132641|NCT00480987|B1|Baseline|Oxaliplatin + Cytarabine + Fludarabine|Oxaliplatin 30 mg/m^2 intravenous (IV) days 1-4, Cytarabine 500 mg/m^2 by IV continuous infusion days 2-6, Fludarabine 30 mg/m^2 IV days 2-6
1132642|NCT00480987|P1|Participant Flow|Oxaliplatin + Cytarabine + Fludarabine|Oxaliplatin 30 mg/m^2 intravenous (IV) days 1-4, Cytarabine 500 mg/m^2 by IV continuous infusion days 2-6, Fludarabine 30 mg/m^2 IV days 2-6
1132643|NCT00480987|O1|Outcome|Oxaliplatin + Cytarabine + Fludarabine|Oxaliplatin 30 mg/m^2 intravenous (IV) days 1-4, Cytarabine 500 mg/m^2 by IV continuous infusion days 2-6, Fludarabine 30 mg/m^2 IV days 2-6
1132644|NCT00480987|E1|Reported Event|Oxaliplatin + Cytarabine + Fludarabine|Oxaliplatin 30 mg/m^2 intravenous (IV) days 1-4, Cytarabine 500 mg/m^2 by IV continuous infusion days 2-6, Fludarabine 30 mg/m^2 IV days 2-6
1132645|NCT00480857|B1|Baseline|Docetaxel|Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
1132646|NCT00480857|P1|Participant Flow|Docetaxel|Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
1132647|NCT00480857|O1|Outcome|Docetaxel|Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
1132648|NCT00480857|O1|Outcome|Docetaxel|Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
1132649|NCT00480857|E1|Reported Event|Docetaxel|Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
1132650|NCT00480779|B3|Baseline|Total|Total of all reporting groups
1132651|NCT00480779|B2|Baseline|GLB DVD|The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study chose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
1132652|NCT00480779|B1|Baseline|GLB Group|The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study chose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
1134618|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
1132653|NCT00480779|P2|Participant Flow|GLB DVD|The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study chose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
1132654|NCT00480779|P1|Participant Flow|GLB Group|The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study chose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
1132655|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
1132678|NCT00480740|B3|Baseline|Fontan Physiology|
1132679|NCT00480740|B2|Baseline|Cardiac Transplant|
1132680|NCT00480740|B1|Baseline|Normal Physiology|
1132681|NCT00480740|P3|Participant Flow|Fontan Physiology|diagnostic cardiac catheterization in children with a transplanted ventricle
1132682|NCT00480740|P2|Participant Flow|Cardiac Transplant|diagnostic cardiac catheterization in children with a transplanted heart
1132683|NCT00480740|P1|Participant Flow|Normal Physiology|diagnostic cardiac catheterization in children with normal cardiac physiology
1132656|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
1132657|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
1132658|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
1132659|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
1132660|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
1132717|NCT00480324|E2|Reported Event|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
1132718|NCT00480324|E1|Reported Event|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
1132719|NCT00479882|B5|Baseline|Total|Total of all reporting groups
1132661|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
1132662|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
1132684|NCT00480740|O3|Outcome|Fontan Physiology|diagnostic cardiac catheterization in children with a transplanted ventricle
1132685|NCT00480740|O2|Outcome|Cardiac Transplant|diagnostic cardiac catheterization in children with a transplanted heart
1132686|NCT00480740|O1|Outcome|Normal Physiology|diagnostic cardiac catheterization in children with normal cardiac physiology
1133739|NCT00477269|O1|Outcome|STI571|STI571
1132663|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
1132664|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
1132665|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
1132666|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
1132667|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
1132720|NCT00479882|B4|Baseline|Sequence 4: MK-0524A 2g+Simvastatin 40mg →MK-0524B 1.8g/40mg|After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 40 mg for 4 weeks, then co-administration MK-0524A 2g +simvastatin 40 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/40 mg combination tablet for 8 weeks.
1132721|NCT00479882|B3|Baseline|Sequence 3: MK-0524B 1.8g/40mg→MK-0524A 2g+Simvastatin 40mg|After a 2-week placebo run-in, participants will receive MK-0524B 0.9g/40 mg combination tablet for 4 weeks, then MK-0524B 1.8g /40 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 40 mg for 8 weeks.
1134619|NCT00474630|O2|Outcome|Placebo|Placebo
1132668|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
1132669|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
1132670|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
1132671|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
1132672|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
1132673|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
1132674|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
1132722|NCT00479882|B2|Baseline|Sequence 2: MK-0524A 2g+Simvastatin 20mg →MK-0524B 1.8g/20mg|After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 10 mg for 4 weeks, then co-administered MK-0524A 2g +simvastatin 20 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/20 mg combination tablet for 8 weeks.
1132723|NCT00479882|B1|Baseline|Sequence 1: MK-0524B 1.8g/20mg→MK-0524A 2g+Simvastatin 20mg|After a 2-week placebo run-in, participants will receive MK-0524B (0.9 g/simvastatin 10 mg) for 4 weeks, then MK-0524B 1.8g /20 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 20 mg for 8 weeks.
1132763|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
1132675|NCT00480779|E2|Reported Event|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD:The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
1132676|NCT00480779|E1|Reported Event|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
1132687|NCT00480740|E3|Reported Event|Normal Physiology|"control group~Dexmedetomidine: Dexmedetomidine load of 1 microgram/kilogram over 10 minutes, followed by a 1 microgram/kilogram/hour infusion during the time of catheterization"
1132688|NCT00480740|E2|Reported Event|Fontan Procedure|Dexmedetomidine: Dexmedetomidine load of 1 microgram/kilogram over 10 minutes, followed by a 1 microgram/kilogram/hour infusion during the time of catheterization
1132689|NCT00480740|E1|Reported Event|Cardiac Transplant|Dexmedetomidine: Dexmedetomidine load of 1 microgram/kilogram over 10 minutes, followed by a 1 microgram/kilogram/hour infusion during the time of catheterization
1132690|NCT00480324|B3|Baseline|Total|Total of all reporting groups
1132691|NCT00480324|B2|Baseline|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
1132692|NCT00480324|B1|Baseline|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
1132693|NCT00480324|P2|Participant Flow|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
1132694|NCT00480324|P1|Participant Flow|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
1132695|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
1132696|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
1132697|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
1132698|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
1132699|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
1132700|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
1132701|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
1132702|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
1132703|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
1132704|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
1132705|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
1132706|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
1132707|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
1132708|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
1132709|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
1132710|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
1132711|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
1132712|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
1132713|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
1132714|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
1132715|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
1132716|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
1140880|NCT00460239|O7|Outcome|Buprenorphine 48 mg|
1132724|NCT00479882|P4|Participant Flow|Sequence 4: MK-0524A 2g+Simvastatin 40mg →MK-0524B 1.8g/40mg|After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 40 mg for 4 weeks, then co-administration MK-0524A 2g +simvastatin 40 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/40 mg combination tablet for 8 weeks.
1132725|NCT00479882|P3|Participant Flow|Sequence 3: MK-0524B 1.8g/40mg→MK-0524A 2g+Simvastatin 40mg|After a 2-week placebo run-in, participants will receive MK-0524B 0.9g/40 mg combination tablet for 4 weeks, then MK-0524B 1.8g /40 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 40 mg for 8 weeks.
1132726|NCT00479882|P2|Participant Flow|Sequence 2: MK-0524A 2g+Simvastatin 20mg →MK-0524B 1.8g/20mg|After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 10 mg for 4 weeks, then co-administered MK-0524A 2g +simvastatin 20 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/20 mg combination tablet for 8 weeks.
1132727|NCT00479882|P1|Participant Flow|Sequence 1: MK-0524B 1.8g/20mg→MK-0524A 2g+Simvastatin 20mg|After a 2-week placebo run-in, participants will receive MK-0524B (0.9 g/simvastatin 10 mg) for 4 weeks, then MK-0524B 1.8g /20 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 20 mg for 8 weeks.
1132728|NCT00479882|O4|Outcome|MK-0524A 1 g + Simvastatin 40 mg|Participants who received MK-0524A 1g+Simvastatin 40mg for 4 weeks in Period I regardless of randomly assigned sequence.
1132729|NCT00479882|O3|Outcome|MK-0524B 0.9 g/40 mg|Participants who received MK-0524B 0.9g/40mg for 4 weeks in Period I regardless of randomly assigned sequence.
1132730|NCT00479882|O2|Outcome|MK-0524A 1g+Simvastatin 10mg|Participants who received MK-0524A 1g+Simvastatin 10mg for 4 weeks in Period I regardless of randomly assigned sequence.
1132731|NCT00479882|O1|Outcome|MK-0524B 0.9g/10mg|Participants who received MK-0524B 0.9g/10mg for 4 weeks in Period I regardless of randomly assigned sequence.
1132732|NCT00479882|O4|Outcome|MK-0524A 1 g + Simvastatin 40 mg|Participants who received MK-0524A 1g+Simvastatin 40mg for 4 weeks in Period I regardless of randomly assigned sequence.
1132733|NCT00479882|O3|Outcome|MK-0524B 0.9 g/40 mg|Participants who received MK-0524B 0.9g/40mg for 4 weeks in Period I regardless of randomly assigned sequence.
1132734|NCT00479882|O2|Outcome|MK-0524A 1g+Simvastatin 10mg|Participants who received MK-0524A 1g+Simvastatin 10mg for 4 weeks in Period I regardless of randomly assigned sequence.
1132735|NCT00479882|O1|Outcome|MK-0524B 0.9g/10mg|Participants who received MK-0524B 0.9g/10mg for 4 weeks in Period I regardless of randomly assigned sequence.
1132736|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
1132737|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
1132738|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
1132739|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
1132740|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
1132741|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
1132742|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
1132743|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
1132744|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
1132745|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
1132746|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
1132747|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
1132748|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
1132749|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
1132750|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
1132751|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
1132752|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
1132753|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
1132754|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
1132755|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
1132756|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
1132757|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
1132758|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
1132759|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
1132760|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
1132761|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
1132765|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
1132766|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
1132767|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
1132768|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
1132769|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
1132770|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
1132771|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
1132772|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
1132773|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
1132774|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
1132775|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
1132776|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
1132777|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
1132778|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
1132779|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
1132780|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
1132781|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
1133016|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
1132782|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
1132783|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
1132784|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
1132785|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
1132786|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
1132787|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
1132788|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
1132789|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
1132790|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
1132791|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
1132792|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
1132793|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
1132794|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
1132795|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
1132796|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
1132797|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
1132798|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
1132799|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
1132800|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
1132801|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
1132802|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
1132803|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
1132804|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
1132805|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
1132806|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
1134620|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
1132807|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
1132808|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
1132809|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
1132810|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
1132811|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
1132812|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
1132813|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
1132814|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
1132815|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
1132816|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
1132817|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
1132818|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
1132819|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
1132820|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
1132821|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
1132822|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
1132823|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
1132824|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
1132825|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
1132826|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
1132827|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
1132828|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
1132829|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
1132830|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
1132831|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
1132832|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
1132833|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
1132834|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
1132835|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
1132836|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
1132837|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
1132838|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
1132839|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
1132840|NCT00479882|O4|Outcome|MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
1132841|NCT00479882|O3|Outcome|MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg for 8 weeks in either Period II or Period III treatment period regardless of randomly assigned sequence.
1132842|NCT00479882|O2|Outcome|MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 2g+Simvastatin 20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
1132843|NCT00479882|O1|Outcome|MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
1132844|NCT00479882|O4|Outcome|MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
1132845|NCT00479882|O3|Outcome|MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg for 8 weeks in either Period II or Period III treatment period regardless of randomly assigned sequence.
1132846|NCT00479882|O2|Outcome|MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 2g+Simvastatin 20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
1132847|NCT00479882|O1|Outcome|MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
1132849|NCT00479882|E7|Reported Event|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
1132850|NCT00479882|E6|Reported Event|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II
1132851|NCT00479882|E5|Reported Event|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
1132852|NCT00479882|E4|Reported Event|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
1132853|NCT00479882|E3|Reported Event|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524B 1g + Simvastatin 20mg and MK-0524B 2g+ Simvastatin 20mg during Period III
1132854|NCT00479882|E2|Reported Event|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524B 1g + Simvastatin 20mg and MK-0524B 2g+ Simvastatin 20mg during Periods I/II
1132855|NCT00479882|E1|Reported Event|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
1132856|NCT00479856|B1|Baseline|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:~(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
1132857|NCT00479856|P1|Participant Flow|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:~(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
1132858|NCT00479856|O1|Outcome|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:~(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
1132888|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
1133017|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
1132859|NCT00479856|O1|Outcome|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:~(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
1132860|NCT00479856|O1|Outcome|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:~(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
1132861|NCT00479856|O1|Outcome|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:~(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
1132862|NCT00479856|O1|Outcome|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:~(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
1132863|NCT00479856|O1|Outcome|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:~(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
1132864|NCT00479856|E1|Reported Event|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:~(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
1132865|NCT00479765|B1|Baseline|OncoGel 5mL|"OncoGel 5 mL administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel~OncoGel (ReGel/Paclitaxel): OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection."
1132866|NCT00479765|P1|Participant Flow|OncoGel|"OncoGel administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel~OncoGel (ReGel/Paclitaxel): OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection."
1132867|NCT00479765|O1|Outcome|OncoGel 5mL|"OncoGel 5 mL administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel~OncoGel (ReGel/Paclitaxel): OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection."
1132868|NCT00479765|E1|Reported Event|OncoGel 5mL|"OncoGel 5 mL administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel~OncoGel (ReGel/Paclitaxel): OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection."
1132869|NCT00479713|B3|Baseline|Total|Total of all reporting groups
1132870|NCT00479713|B2|Baseline|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
1132871|NCT00479713|B1|Baseline|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
1134621|NCT00474630|O2|Outcome|Placebo|Placebo
1132872|NCT00479713|P2|Participant Flow|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
1132873|NCT00479713|P1|Participant Flow|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
1132874|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
1132875|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
1132876|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
1132877|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
1132878|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
1132879|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
1132880|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
1132881|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
1132882|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
1132883|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
1132884|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
1132885|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
1132886|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
1132887|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
1132889|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
1132890|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
1132891|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
1132892|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
1132893|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
1132894|NCT00479713|E2|Reported Event|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
1132895|NCT00479713|E1|Reported Event|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
1132896|NCT00479674|B1|Baseline|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15~Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..~Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.~Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
1132897|NCT00479674|P1|Participant Flow|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15~Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..~Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.~Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
1132898|NCT00479674|O1|Outcome|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15~Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..~Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.~Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
1132899|NCT00479674|O1|Outcome|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15~Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..~Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.~Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
1132926|NCT00479557|O7|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132927|NCT00479557|O6|Outcome|QS-21 Alone|Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1134622|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
1132900|NCT00479674|O1|Outcome|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15~Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..~Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.~Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
1132901|NCT00479674|O1|Outcome|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15~Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..~Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.~Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
1132902|NCT00479674|O1|Outcome|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15~Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..~Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.~Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
1132903|NCT00479674|E1|Reported Event|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15~Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..~Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.~Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
1132905|NCT00479557|B7|Baseline|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132906|NCT00479557|B6|Baseline|QS-21 Alone|Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132907|NCT00479557|B5|Baseline|ACC 30 µg|Participants received 30 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132908|NCT00479557|B4|Baseline|ACC 10 µg|Participants received 10 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132909|NCT00479557|B3|Baseline|ACC 30 µg+QS-21|Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132910|NCT00479557|B2|Baseline|ACC 10 µg+QS-21|Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132911|NCT00479557|B1|Baseline|ACC 3 µg+QS-21|Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132912|NCT00479557|P7|Participant Flow|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132913|NCT00479557|P6|Participant Flow|QS-21 Alone|Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132914|NCT00479557|P5|Participant Flow|ACC 30 µg|Participants received 30 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132915|NCT00479557|P4|Participant Flow|ACC 10 µg|Participants received 10 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132916|NCT00479557|P3|Participant Flow|ACC 30 µg+QS-21|Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132917|NCT00479557|P2|Participant Flow|ACC 10 µg+QS-21|Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132918|NCT00479557|P1|Participant Flow|ACC 3 µg+QS-21|Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132919|NCT00479557|O7|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132920|NCT00479557|O6|Outcome|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132921|NCT00479557|O5|Outcome|ACC 30 μg|Participants received 30 μg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132922|NCT00479557|O4|Outcome|ACC 10 μg|Participants received 10 μg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132923|NCT00479557|O3|Outcome|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132924|NCT00479557|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132925|NCT00479557|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132928|NCT00479557|O5|Outcome|ACC 30 µg|Participants received 30 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132929|NCT00479557|O4|Outcome|ACC 10 µg|Participants received 10 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132930|NCT00479557|O3|Outcome|ACC 30 µg+QS-21|Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132931|NCT00479557|O2|Outcome|ACC 10 µg+QS-21|Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132932|NCT00479557|O1|Outcome|ACC 3 µg+QS-21|Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132933|NCT00479557|O7|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132934|NCT00479557|O6|Outcome|QS-21 Alone|Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132935|NCT00479557|O5|Outcome|ACC 30 µg|Participants received 30 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132936|NCT00479557|O4|Outcome|ACC 10 µg|Participants received 10 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132937|NCT00479557|O3|Outcome|ACC 30 µg+QS-21|Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132938|NCT00479557|O2|Outcome|ACC 10 µg+QS-21|Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132939|NCT00479557|O1|Outcome|ACC 3 µg+QS-21|Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132940|NCT00479557|O7|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1133071|NCT00479336|O4|Outcome|OPC-41061 30 mg|30 mg, 1 tablet a day
1132941|NCT00479557|O6|Outcome|QS-21 Alone|Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132942|NCT00479557|O5|Outcome|ACC 30 µg|Participants received 30 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132943|NCT00479557|O4|Outcome|ACC 10 µg|Participants received 10 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132944|NCT00479557|O3|Outcome|ACC 30 µg+QS-21|Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132945|NCT00479557|O2|Outcome|ACC 10 µg+QS-21|Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132946|NCT00479557|O1|Outcome|ACC 3 µg+QS-21|Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132947|NCT00479557|E7|Reported Event|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132948|NCT00479557|E6|Reported Event|QS-21 Alone|Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132949|NCT00479557|E5|Reported Event|ACC 30 µg|Participants received 30 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132950|NCT00479557|E4|Reported Event|ACC 10 µg|Participants received 10 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132951|NCT00479557|E3|Reported Event|ACC 30 µg+QS-21|Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132952|NCT00479557|E2|Reported Event|ACC 10 µg+QS-21|Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132953|NCT00479557|E1|Reported Event|ACC 3 µg+QS-21|Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
1132954|NCT00479466|B7|Baseline|Total|Total of all reporting groups
1132955|NCT00479466|B6|Baseline|Metformin HCL|
1132956|NCT00479466|B5|Baseline|MK0893 80 mg|
1132957|NCT00479466|B4|Baseline|MK0893 60 mg|
1132958|NCT00479466|B3|Baseline|MK0893 40 mg|
1132959|NCT00479466|B2|Baseline|MK0893 20 mg|
1132960|NCT00479466|B1|Baseline|Placebo|
1132961|NCT00479466|P6|Participant Flow|Metformin HCL|
1132962|NCT00479466|P5|Participant Flow|MK0893 80 mg|
1132963|NCT00479466|P4|Participant Flow|MK0893 60 mg|
1132964|NCT00479466|P3|Participant Flow|MK0893 40 mg|
1132965|NCT00479466|P2|Participant Flow|MK0893 20 mg|
1132966|NCT00479466|P1|Participant Flow|Placebo|
1132967|NCT00479466|O6|Outcome|Metformin HCL|
1132968|NCT00479466|O5|Outcome|MK0893 80 mg|
1132969|NCT00479466|O4|Outcome|MK0893 60 mg|
1132970|NCT00479466|O3|Outcome|MK0893 40 mg|
1132971|NCT00479466|O2|Outcome|MK0893 20 mg|
1132972|NCT00479466|O1|Outcome|Placebo|
1132973|NCT00479466|O6|Outcome|Metformin HCL|
1132974|NCT00479466|O5|Outcome|MK0893 80 mg|
1132975|NCT00479466|O4|Outcome|MK0893 60 mg|
1132976|NCT00479466|O3|Outcome|MK0893 40 mg|
1132977|NCT00479466|O2|Outcome|MK0893 20 mg|
1132978|NCT00479466|O1|Outcome|Placebo|
1132979|NCT00479466|O6|Outcome|Metformin HCL|
1132994|NCT00479401|B1|Baseline|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
1132995|NCT00479401|P3|Participant Flow|Placebo|Placebo to PPX ER once and to PPX IR three times a day
1132996|NCT00479401|P2|Participant Flow|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
1132997|NCT00479401|P1|Participant Flow|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
1132998|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
1132999|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
1133000|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
1133001|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
1133002|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
1133003|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
1133004|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
1133005|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
1133006|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
1133007|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
1133008|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
1133009|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
1133010|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
1133011|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
1133012|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
1133013|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
1133014|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
1133015|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
1133072|NCT00479336|O3|Outcome|OPC-41061 15 mg|15 mg, 1 tablet a day
1133018|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
1133019|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
1133020|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
1133021|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
1133022|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
1133023|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
1133024|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
1133025|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
1133026|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
1133027|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
1133028|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
1133029|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
1133030|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
1133031|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
1133032|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
1133033|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
1133034|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
1133035|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
1133036|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
1133037|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
1133038|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
1133039|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
1133040|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
1133041|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
1133042|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
1133043|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
1133044|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
1133045|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
1133046|NCT00479401|E3|Reported Event|Placebo|Placebo to PPX ER once and to PPX IR three times a day
1133047|NCT00479401|E2|Reported Event|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
1133048|NCT00479401|E1|Reported Event|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
1133049|NCT00479388|B3|Baseline|Total|Total of all reporting groups
1133050|NCT00479388|B2|Baseline|Run-in Statin Dose Doubled|Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
1133051|NCT00479388|B1|Baseline|ER Niacin/Laropiprant + Run-in Statin|One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
1134623|NCT00474630|O2|Outcome|Placebo|Placebo
1133052|NCT00479388|P2|Participant Flow|Run-in Statin Dose Doubled|Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
1133053|NCT00479388|P1|Participant Flow|ER Niacin/Laropiprant + Run-in Statin|One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
1133054|NCT00479388|O2|Outcome|Run-in Statin Dose Doubled|Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
1133055|NCT00479388|O1|Outcome|ER Niacin/Laropiprant + Run-in Statin|One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
1133056|NCT00479388|O2|Outcome|Run-in Statin Dose Doubled|Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
1133057|NCT00479388|O1|Outcome|ER Niacin/Laropiprant + Run-in Statin|One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
1133058|NCT00479388|O2|Outcome|Run-in Statin Dose Doubled|Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
1133059|NCT00479388|O1|Outcome|ER Niacin/Laropiprant + Run-in Statin|One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
1133060|NCT00479388|E2|Reported Event|Run-in Statin Dose Doubled|Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
1133061|NCT00479388|E1|Reported Event|ER Niacin/Laropiprant + Run-in Statin|One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
1133062|NCT00479336|B5|Baseline|Total|Total of all reporting groups
1133063|NCT00479336|B4|Baseline|OPC-41061 30 mg|30 mg, 1 tablet a day
1133064|NCT00479336|B3|Baseline|OPC-41061 15 mg|15 mg, 1 tablet a day
1133065|NCT00479336|B2|Baseline|OPC-41061 7.5 mg|7.5 mg, 1 tablet a day
1133066|NCT00479336|B1|Baseline|Placebo|Placebo, 1 tablet a day
1133067|NCT00479336|P4|Participant Flow|OPC-41061 30 mg|30 mg, 1 tablet a day
1133068|NCT00479336|P3|Participant Flow|OPC-41061 15 mg|15 mg, 1 tablet a day
1133069|NCT00479336|P2|Participant Flow|OPC-41061 7.5 mg|7.5 mg, 1 tablet a day
1133070|NCT00479336|P1|Participant Flow|Placebo|Placebo, 1 tablet a day
1133081|NCT00479336|E2|Reported Event|OPC-41061 7.5 mg|7.5 mg, 1 tablet a day
1133082|NCT00479336|E1|Reported Event|Placebo|Placebo, 1 tablet a day
1133083|NCT00479258|B3|Baseline|Total|Total of all reporting groups
1133084|NCT00479258|B2|Baseline|Subcutaneous Insulin (Subject's Prescribed)|No subjects received study medication.
1133085|NCT00479258|B1|Baseline|Inhaled Insulin (Exubera)|No subjects received study medication.
1133086|NCT00479258|P2|Participant Flow|Subcutaneous Insulin (Subject's Prescribed)|No subjects received study medication.
1133087|NCT00479258|P1|Participant Flow|Inhaled Insulin (Exubera)|No subjects received study medication.
1133088|NCT00479258|O2|Outcome|Subcutaneous Insulin (Subject's Prescribed)|No subjects received study medication.
1133089|NCT00479258|O1|Outcome|Inhaled Insulin (Exubera)|No subjects received study medication.
1133090|NCT00479232|B3|Baseline|Total|Total of all reporting groups
1133091|NCT00479232|B2|Baseline|Vorinostat + Decitabine, Sequential|(sequential) Vorinostat 400 mg capsules once daily given 7, 10 or 14 days in 28 day cycles along with decitabine IV 20 mg/m^2 daily for 5 days in each 28 day cycle. Up to 24 months of treatment.
1133092|NCT00479232|B1|Baseline|Vorinostat + Decitabine, Concurrent|(concurrent) Vorinostat 400 mg capsules once daily given 7 days, 14 days with 8 day break after first 7 days or 14 days without break, out of 28 day cycles along with decitabine IV 20 mg/m^2 daily for 5 days in each 28 day cycle. Up to 24 months of treatment.
1133093|NCT00479232|P6|Participant Flow|Sequential, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)|(sequential) vorinostat 400 mg capsules given qd on Days 6 to 19 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
1133094|NCT00479232|P5|Participant Flow|Sequential, Vorinostat 400mg qd x 10d/4wk + Decitabine|(sequential) vorinostat 400 mg capsules given qd on Days 6 to 15 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
1133095|NCT00479232|P4|Participant Flow|Sequential, Vorinostat 400mg qd x 7d/4wk + Decitabine|(sequential) vorinostat 400 mg capsules given qd on Days 6 to 12 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
1133096|NCT00479232|P3|Participant Flow|Concurrent, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)|(concurrent) vorinostat 400 mg capsules given qd on Days 1 to 14 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
1133097|NCT00479232|P2|Participant Flow|Concurrent, Vorinostat 400mg qd x 7d/2wk + Decitabine|(concurrent) vorinostat 400 mg capsules given qd on Days 1 to 7 and Days 15 to 21 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
1133098|NCT00479232|P1|Participant Flow|Concurrent, Vorinostat 400mg qd x 7d/4wk + Decitabine|(concurrent) vorinostat 400 mg capsules given once daily (qd) on Days 1 to 7 in a 28 day cycle, along with decitabine intravenous (IV) 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
1140881|NCT00460239|O6|Outcome|Buprenorphine 32 mg|
1133099|NCT00479232|O2|Outcome|Untreated AML or Intermediate, Sequential|"Participants with Untreated AML or Intermediate-High~Risk MDS who were treated with vorinostat and Decitabine~sequentially."
1133100|NCT00479232|O1|Outcome|Untreated AML or Intermediate, Concurrent|"Participants with Untreated AML or Intermediate-High~Risk MDS who were treated with vorinostat and Decitabine~concurrently."
1133101|NCT00479232|O2|Outcome|Refractory or Relapsed AML, Sequential|Participants with Refractory or Relapsed AML who were treated with vorinostat and Decitabine sequentially.
1133102|NCT00479232|O1|Outcome|Refractory or Relapsed AML, Concurrent|Participants with Refractory or Relapsed AML who were treated with vorinostat and Decitabine concurrently.
1133103|NCT00479232|O6|Outcome|Sequential, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)|(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 19 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
1133104|NCT00479232|O5|Outcome|Sequential, Vorinostat 400mg qd x 10d/4wk + Decitabine|(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 15 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
1133105|NCT00479232|O4|Outcome|Sequential, Vorinostat 400mg qd x 7d/4wk + Decitabine|(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 12 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
1133106|NCT00479232|O3|Outcome|Concurrent, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)|(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 14 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
1133107|NCT00479232|O2|Outcome|Concurrent, Vorinostat 400mg qd x 7d/2wk + Decitabine|(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 7 and Days 15 to 21 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
1133108|NCT00479232|O1|Outcome|Concurrent, Vorinostat 400mg qd x 7d/4wk + Decitabine|(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 7 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
1133109|NCT00479232|E6|Reported Event|Sequential,Vorinostat 400 mg qd x 14d/4wk + Decitabine (MTD)|(sequential) orinostat 400 mg capsules given once daily on Days 6 to 19 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
1133110|NCT00479232|E5|Reported Event|Sequential, Vorinostat 400 mg qd x 10d/4wk + Decitabine|(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 15 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
1133111|NCT00479232|E4|Reported Event|Sequential, Vorinostat 400 mg qd x 7d/4wk + Decitabine|(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 12 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
1133112|NCT00479232|E3|Reported Event|Concurrent, Vorinostat 400 mg qd x 14d/4wk + Decitabine (MTD)|(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 14 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
1133318|NCT00478192|O2|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
1133740|NCT00477269|O2|Outcome|Placebo|Placebo
1133113|NCT00479232|E2|Reported Event|Concurrent, Vorinostat 400 mg qd x 7d/2wk + Decitabine|(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 7 and Days 15 to 21 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
1133114|NCT00479232|E1|Reported Event|Concurrent, Vorinostat 400 mg qd x 7d/4wk + Decitabine|(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 7 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
1133115|NCT00479154|B3|Baseline|Total|Total of all reporting groups
1133116|NCT00479154|B2|Baseline|Botulinum Toxin Then Placebo|Injection of Botulinum Toxin (90 mU per leg) followed by crossover to placebo at week 6.
1133117|NCT00479154|B1|Baseline|Placebo Then Botulinum Toxin|Injection into set of leg muscles with Placebo followed by crossover to Botulinum Toxin (90 mU per leg) at week 6.
1133118|NCT00479154|P2|Participant Flow|Botulinum Toxin Then Placebo|Injection of Botulinum Toxin (90 mU per leg) followed by crossover to placebo at week 6.
1133119|NCT00479154|P1|Participant Flow|Placebo Then Botulinum Toxin|Injection into set of leg muscles with Placebo followed by crossover to Botulinum Toxin (90 mU per leg) at week 6.
1133120|NCT00479154|O2|Outcome|Botulinum Toxin|Injection of Botulinum Toxin (90 mU per leg).
1133121|NCT00479154|O1|Outcome|Placebo|Injection into set of leg muscles with Placebo.
1133122|NCT00479154|E2|Reported Event|Botulinum Toxin Then Placebo|Injection of Botulinum Toxin (90 mU per leg) followed by crossover to placebo at week 6.
1133123|NCT00479154|E1|Reported Event|Placebo Then Botulinum Toxin|Injection into set of leg muscles with Placebo followed by crossover to Botulinum Toxin (90 mU per leg) at week 6.
1133124|NCT00479089|B3|Baseline|Total|Total of all reporting groups
1133125|NCT00479089|B2|Baseline|Weekly Docetaxel + ZD1839|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break.
1133126|NCT00479089|B1|Baseline|Weekly Docetaxel|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.
1133127|NCT00479089|P2|Participant Flow|Weekly Docetaxel + ZD1839|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break.
1133128|NCT00479089|P1|Participant Flow|Weekly Docetaxel|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.
1133129|NCT00479089|O2|Outcome|Weekly Docetaxel + ZD1839|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break.
1133130|NCT00479089|O1|Outcome|Weekly Docetaxel|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.
1133131|NCT00479089|O2|Outcome|Weekly Docetaxel + ZD1839|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break.
1133347|NCT00478036|E3|Reported Event|Refresh Tears|"Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days~Refresh Tears: Placebo"
1133132|NCT00479089|O1|Outcome|Weekly Docetaxel|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.
1133133|NCT00479089|O2|Outcome|Weekly Docetaxel + ZD1839|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break.
1133134|NCT00479089|O1|Outcome|Weekly Docetaxel|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.
1133135|NCT00479089|E2|Reported Event|Weekly Docetaxel + ZD1839|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break.
1133136|NCT00479089|E1|Reported Event|Weekly Docetaxel|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.
1133137|NCT00479037|B3|Baseline|Total|Total of all reporting groups
1133138|NCT00479037|B2|Baseline|Strontium Ranelate|One sachet (2 g) per day, suspended in water
1133139|NCT00479037|B1|Baseline|PTH(1-84)|Once daily subcutaneous injection
1133140|NCT00479037|P2|Participant Flow|Strontium Ranelate|One sachet (2 g) per day, suspended in water
1133141|NCT00479037|P1|Participant Flow|PTH(1-84)|Once daily subcutaneous injection
1133142|NCT00479037|O2|Outcome|Strontium Ranelate|One sachet (2 g) per day, suspended in water
1133143|NCT00479037|O1|Outcome|PTH(1-84)|Once daily subcutaneous injection
1133144|NCT00479037|O2|Outcome|Strontium Ranelate|One sachet (2 g) per day, suspended in water
1133145|NCT00479037|O1|Outcome|PTH(1-84)|Once daily subcutaneous injection
1133146|NCT00479037|O2|Outcome|Strontium Ranelate|One sachet (2 g) per day, suspended in water
1133147|NCT00479037|O1|Outcome|PTH(1-84)|Once daily subcutaneous injection
1133148|NCT00479037|E2|Reported Event|Strontium Ranelate|One sachet (2 g) per day, suspended in water
1133149|NCT00479037|E1|Reported Event|PTH(1-84)|Once daily subcutaneous injection
1133150|NCT00478881|B3|Baseline|Total|Total of all reporting groups
1133151|NCT00478881|B2|Baseline|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
1133152|NCT00478881|B1|Baseline|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
1133153|NCT00478881|P2|Participant Flow|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
1133154|NCT00478881|P1|Participant Flow|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
1133155|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
1133156|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
1133157|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
1133319|NCT00478192|O1|Outcome|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
1133158|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
1133159|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
1133160|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
1133161|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
1133162|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
1133163|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
1133164|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
1133165|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
1133166|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
1133167|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
1133168|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
1133169|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
1133170|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
1133171|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
1133172|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
1133173|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
1133174|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
1133175|NCT00478881|E2|Reported Event|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
1133176|NCT00478881|E1|Reported Event|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
1133177|NCT00478777|B1|Baseline|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
1133212|NCT00478569|O1|Outcome|Parathyroid Hormone (PTH) (1-84)|PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
1133213|NCT00478569|O4|Outcome|24 Months|
1133178|NCT00478777|P1|Participant Flow|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
1133179|NCT00478777|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
1133180|NCT00478777|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
1133181|NCT00478777|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
1133182|NCT00478777|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
1133183|NCT00478777|E1|Reported Event|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
1133184|NCT00478673|B1|Baseline|NexStent Carotid Stent System|Subjects in this arm had carotid artery disease treated with the NexStent Carotid Stent System used in conjunction with the FilterWire EZ Embolic Protection System. The NexStent Carotid Stent is a rolled metal mesh sheet constrained in a sheath. The stent is inserted through the groin and is opened in the blocked carotid artery. The FilterWire EZ Embolic Protection System is a temporary filtration system used to contain and remove embolic material that may be released during the stenting procedure.
1133239|NCT00478244|B1|Baseline|Epidermolysis Bullosa (EB) Patients|Epidermolysis bullosa patients enrolled for treatment with chemotherapy (Busulfan 0.8 or 1.1 mg/kg Days 6-9 before transplant; Fludarabine 25 mg/m^2 Days 3-5 before transplant; Cyclophosphamide 50 mg/kg Days 2-5 before transplant) and stem cell infusion (Day 0) followed by donor epidermal transplant .
1133320|NCT00478192|O3|Outcome|Regimen 3 Placebo|
1133185|NCT00478673|P1|Participant Flow|NexStent Carotid Stent System|Subjects in this arm had carotid artery disease treated with the NexStent Carotid Stent System used in conjunction with the FilterWire EZ Embolic Protection System. The NexStent Carotid Stent is a rolled metal mesh sheet constrained in a sheath. The stent is inserted through the groin and is opened in the blocked carotid artery. The FilterWire EZ Embolic Protection System is a temporary filtration system used to contain and remove embolic material that may be released during the stenting procedure.
1133186|NCT00478673|O1|Outcome|NexStent Carotid Stent System|Subjects in this arm had carotid artery disease treated with the NexStent Carotid Stent System used in conjunction with the FilterWire EZ Embolic Protection System. The NexStent Carotid Stent is a rolled metal mesh sheet constrained in a sheath. The stent is inserted through the groin and is opened in the blocked carotid artery. The FilterWire EZ Embolic Protection System is a temporary filtration system used to contain and remove embolic material that may be released during the stenting procedure.
1133187|NCT00478673|O1|Outcome|NexStent Carotid Stent System|Subjects in this arm had carotid artery disease treated with the NexStent Carotid Stent System used in conjunction with the FilterWire EZ Embolic Protection System. The NexStent Carotid Stent is a rolled metal mesh sheet constrained in a sheath. The stent is inserted through the groin and is opened in the blocked carotid artery. The FilterWire EZ Embolic Protection System is a temporary filtration system used to contain and remove embolic material that may be released during the stenting procedure.
1133188|NCT00478673|E1|Reported Event|NexStent Carotid Stent System|Subjects in this arm had carotid artery disease treated with the NexStent Carotid Stent System used in conjunction with the FilterWire EZ Embolic Protection System. The NexStent Carotid Stent is a rolled metal mesh sheet constrained in a sheath. The stent is inserted through the groin and is opened in the blocked carotid artery. The FilterWire EZ Embolic Protection System is a temporary filtration system used to contain and remove embolic material that may be released during the stenting procedure.
1133189|NCT00478647|B1|Baseline|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
1133190|NCT00478647|P1|Participant Flow|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
1133191|NCT00478647|O1|Outcome|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
1133192|NCT00478647|O1|Outcome|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
1133193|NCT00478647|O1|Outcome|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
1133194|NCT00478647|O1|Outcome|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
1133195|NCT00478647|O1|Outcome|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
1133196|NCT00478647|E1|Reported Event|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
1133197|NCT00478608|B1|Baseline|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.~On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.~CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.~Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
1133214|NCT00478569|O3|Outcome|18 Months|
1133215|NCT00478569|O2|Outcome|12 Months|
1133198|NCT00478608|P1|Participant Flow|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.~On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.~CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.~Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
1133199|NCT00478608|O1|Outcome|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.~On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.~CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.~Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
1133200|NCT00478608|O1|Outcome|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.~On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.~CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.~Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
1133310|NCT00478192|O1|Outcome|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
1133311|NCT00478192|O3|Outcome|Regimen 3 Placebo|
1133201|NCT00478608|O1|Outcome|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.~On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.~CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.~Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
1133202|NCT00478608|O1|Outcome|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.~On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.~CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.~Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
1133203|NCT00478608|O1|Outcome|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.~On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.~CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.~Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
1133204|NCT00478608|E1|Reported Event|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.~On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.~CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.~Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
1133205|NCT00478569|B1|Baseline|Parathyroid Hormone (PTH) (1-84)|PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
1133206|NCT00478569|P1|Participant Flow|Parathyroid Hormone (PTH) (1-84)|PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
1133207|NCT00478569|O5|Outcome|24 Months|
1133208|NCT00478569|O4|Outcome|18 Months|
1133209|NCT00478569|O3|Outcome|12 Months|
1133217|NCT00478569|O1|Outcome|Parathyroid Hormone (PTH) (1-84)|PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
1133218|NCT00478569|E1|Reported Event|Parathyroid Hormone (PTH) (1-84)|PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
1133219|NCT00478556|B3|Baseline|Total|Total of all reporting groups
1133220|NCT00478556|B2|Baseline|Omnipaque|Oral Omnipaque prior to CT
1133221|NCT00478556|B1|Baseline|Gastroview|Oral Gastroview prior to CT
1133222|NCT00478556|P2|Participant Flow|Omnipaque Group|Patients ill be given oral Omnipaque (contrast) prior to Computerized Tomography (CT).
1133223|NCT00478556|P1|Participant Flow|Gastroview Group|Patients will be given oral Gastroview (contrast) prior to Computerized Tomography (CT).
1133224|NCT00478556|O2|Outcome|Omnipaque|Oral Omnipaque prior to CT
1133225|NCT00478556|O1|Outcome|Gastroview|Oral Gastroview prior to CT
1133226|NCT00478556|O2|Outcome|Omnipaque|Oral Omnipaque prior to CT
1133227|NCT00478556|O1|Outcome|Gastroview|Oral Gastroview prior to CT
1133228|NCT00478556|E2|Reported Event|Omnipaque|Oral Omnipaque prior to CT
1133229|NCT00478556|E1|Reported Event|Gastroview|Oral Gastroview prior to CT
1133230|NCT00478257|B3|Baseline|Total|Total of all reporting groups
1133231|NCT00478257|B2|Baseline|Effect of Red Light|effect of red light on fatigue in women with breast cancer
1133232|NCT00478257|B1|Baseline|Effect of Bright Light|Effect of bright light on fatigue in women with breast cancer
1133233|NCT00478257|P2|Participant Flow|Effect of Red Light|effect of red light on fatigue in women with breast cancer
1133234|NCT00478257|P1|Participant Flow|Effect of Bright Light|Effect of bright light on fatigue in women with breast cancer
1133235|NCT00478257|O2|Outcome|Effect of Red Light|effect of red light on fatigue in women with breast cancer
1133236|NCT00478257|O1|Outcome|Effect of Bright Light|Effect of bright light on fatigue in women with breast cancer
1133237|NCT00478257|E2|Reported Event|Effect of Red Light|effect of red light on fatigue in women with breast cancer
1133238|NCT00478257|E1|Reported Event|Effect of Bright Light|Effect of bright light on fatigue in women with breast cancer
1133312|NCT00478192|O2|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
1133313|NCT00478192|O1|Outcome|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
1133314|NCT00478192|O3|Outcome|Regimen 3 Placebo|
1133240|NCT00478244|P1|Participant Flow|Epidermolysis Bullosa (EB) Patients|Epidermolysis bullosa patients enrolled for treatment with chemotherapy (Busulfan 0.8 or 1.1 mg/kg Days 6-9 before transplant; Fludarabine 25 mg/m^2 Days 3-5 before transplant; Cyclophosphamide 50 mg/kg Days 2-5 before transplant) and stem cell infusion (Day 0) followed by donor epidermal transplant .
1133241|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
1133242|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
1133243|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
1133244|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
1133245|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
1133246|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
1133247|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
1133248|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
1133249|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
1133250|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
1133251|NCT00478244|E1|Reported Event|Epidermolysis Bullosa (EB) Patients|Epidermolysis bullosa patients enrolled for treatment with chemotherapy (Busulfan 0.8 or 1.1 mg/kg Days 6-9 before transplant; Fludarabine 25 mg/m^2 Days 3-5 before transplant; Cyclophosphamide 50 mg/kg Days 2-5 before transplant) and stem cell infusion (Day 0) followed by donor epidermal transplant .
1133252|NCT00478231|B1|Baseline|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
1133253|NCT00478231|P1|Participant Flow|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
1133254|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
1133255|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
1133256|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
1133257|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
1133258|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
1133346|NCT00478036|O1|Outcome|Acular LS|"Acular LS - 1 drop in treated eye, 4 times a day, for 4 days~Acular LS: Details covered in arm description"
1133259|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
1133260|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
1133261|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
1133262|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
1133263|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
1133264|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
1133265|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
1133266|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
1133267|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
1133268|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
1133315|NCT00478192|O2|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
1133316|NCT00478192|O1|Outcome|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
1133269|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
1133270|NCT00478231|E1|Reported Event|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
1133271|NCT00478218|B3|Baseline|Total|Total of all reporting groups
1133272|NCT00478218|B2|Baseline|LCD (Cyclophosphamide 300 mg)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
1133273|NCT00478218|B1|Baseline|LCD (Cyclophosphamide 300 mg/m^2)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
1133274|NCT00478218|P2|Participant Flow|LCD (Cyclophosphamide 300 mg)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
1133275|NCT00478218|P1|Participant Flow|LCD (Cyclophosphamide 300 mg/m^2)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
1133276|NCT00478218|O2|Outcome|LCD (Cyclophosphamide 300 mg)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
1133277|NCT00478218|O1|Outcome|LCD (Cyclophosphamide 300 mg/m^2)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
1133278|NCT00478218|O2|Outcome|LCD (Cyclophosphamide 300 mg)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
1133279|NCT00478218|O1|Outcome|LCD (Cyclophosphamide 300 mg/m^2)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
1133280|NCT00478218|O2|Outcome|LCD (Cyclophosphamide 300 mg)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
1133281|NCT00478218|O1|Outcome|LCD (Cyclophosphamide 300 mg/m^2)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
1133282|NCT00478218|O2|Outcome|LCD (Cyclophosphamide 300 mg)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
1133283|NCT00478218|O1|Outcome|LCD (Cyclophosphamide 300 mg/m^2)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
1133284|NCT00478218|E2|Reported Event|LCD (Cyclophosphamide 300 mg)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
1133285|NCT00478218|E1|Reported Event|LCD (Cyclophosphamide 300 mg/m^2)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
1133286|NCT00478205|B3|Baseline|Total|Total of all reporting groups
1133287|NCT00478205|B2|Baseline|Donepezil IR 10 mg|Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.
1133288|NCT00478205|B1|Baseline|Donepezil SR 23 mg|Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
1133289|NCT00478205|P2|Participant Flow|Donepezil IR 10 mg|Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.
1133290|NCT00478205|P1|Participant Flow|Donepezil SR 23 mg|Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
1133291|NCT00478205|O2|Outcome|Donepezil IR 10 mg|Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.
1134624|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
1133292|NCT00478205|O1|Outcome|Donepezil SR 23 mg|Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
1133293|NCT00478205|O2|Outcome|Donepezil IR 10 mg|Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.
1133294|NCT00478205|O1|Outcome|Donepezil SR 23 mg|Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
1133295|NCT00478205|O2|Outcome|Donepezil IR 10 mg|Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.
1133296|NCT00478205|O1|Outcome|Donepezil SR 23 mg|Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
1133297|NCT00478205|O2|Outcome|Donepezil IR 10 mg|Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.
1133298|NCT00478205|O1|Outcome|Donepezil SR 23 mg|Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
1133299|NCT00478205|E2|Reported Event|Donepezil IR 10 mg|Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.
1133300|NCT00478205|E1|Reported Event|Donepezil SR 23 mg|Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
1133301|NCT00478192|B4|Baseline|Total|Total of all reporting groups
1133302|NCT00478192|B3|Baseline|Regimen 3 Placebo|
1133303|NCT00478192|B2|Baseline|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
1133304|NCT00478192|B1|Baseline|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
1133305|NCT00478192|P3|Participant Flow|Regimen 3 Placebo|
1133306|NCT00478192|P2|Participant Flow|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
1133307|NCT00478192|P1|Participant Flow|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
1133308|NCT00478192|O3|Outcome|Regimen 3 Placebo|
1133309|NCT00478192|O2|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
1133321|NCT00478192|O2|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
1133322|NCT00478192|O1|Outcome|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
1133323|NCT00478192|O1|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
1133324|NCT00478192|O3|Outcome|Regimen 3 Placebo|
1133325|NCT00478192|O2|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
1133326|NCT00478192|O1|Outcome|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
1133327|NCT00478192|O3|Outcome|Regimen 3 Placebo|
1133328|NCT00478192|O2|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
1133329|NCT00478192|O1|Outcome|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
1133330|NCT00478192|E3|Reported Event|Regimen 3 Placebo|
1133331|NCT00478192|E2|Reported Event|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
1133332|NCT00478192|E1|Reported Event|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
1133333|NCT00478140|B1|Baseline|Trastuzumab|Trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1133334|NCT00478140|P1|Participant Flow|Trastuzumab|Trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1133335|NCT00478140|O1|Outcome|Trastuzumab|Trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1133336|NCT00478140|E1|Reported Event|Trastuzumab|Trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1133337|NCT00478036|B4|Baseline|Total|Total of all reporting groups
1133338|NCT00478036|B3|Baseline|Predforte Group|Used predforte eye drops
1133339|NCT00478036|B2|Baseline|Acular Group|Used acular LS
1133340|NCT00478036|B1|Baseline|Placebo Group|Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days
1133341|NCT00478036|P3|Participant Flow|Refresh Tears|"Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days~Refresh Tears: Placebo"
1133342|NCT00478036|P2|Participant Flow|Pred Forte|"Pred Forte - 1 drop in treated eye, 4 times a day, for 4 days~Pred Forte: Details covered in arm description"
1133343|NCT00478036|P1|Participant Flow|Acular LS|"Acular LS - 1 drop in treated eye, 4 times a day, for 4 days~Acular LS: Details covered in arm description"
1133344|NCT00478036|O3|Outcome|Refresh Tears|"Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days~Refresh Tears: Placebo"
1133345|NCT00478036|O2|Outcome|Pred Forte|"Pred Forte - 1 drop in treated eye, 4 times a day, for 4 days~Pred Forte: Details covered in arm description"
1133348|NCT00478036|E2|Reported Event|Pred Forte|"Pred Forte - 1 drop in treated eye, 4 times a day, for 4 days~Pred Forte: Details covered in arm description"
1133349|NCT00478036|E1|Reported Event|Acular LS|"Acular LS - 1 drop in treated eye, 4 times a day, for 4 days~Acular LS: Details covered in arm description"
1133350|NCT00478023|B6|Baseline|Total|Total of all reporting groups
1133351|NCT00478023|B5|Baseline|Placebo|Matched Placebo 4 to 6 hourly
1133352|NCT00478023|B4|Baseline|CG5503 100mg|CG5503 IR 100mg 4 to 6 hourly
1133353|NCT00478023|B3|Baseline|CG5503 75mg|CG5503 IR 75mg 4 to 6 hourly
1133354|NCT00478023|B2|Baseline|CG5503 50mg|CG5503 IR 50mg 4 to 6 hourly
1133355|NCT00478023|B1|Baseline|Morphine|Morphine IR 20mg 4-6 hourly
1133356|NCT00478023|P5|Participant Flow|Placebo|Matched Placebo 4 to 6 hourly
1133357|NCT00478023|P4|Participant Flow|CG5503 100mg|CG5503 IR 100mg 4 to 6 hourly
1133358|NCT00478023|P3|Participant Flow|CG5503 75mg|CG5503 IR 75mg 4 to 6 hourly
1133359|NCT00478023|P2|Participant Flow|CG5503 50mg|CG5503 IR 50mg 4 to 6 hourly
1133360|NCT00478023|P1|Participant Flow|Morphine|Morphine IR 20mg 4-6 hourly
1133361|NCT00478023|O5|Outcome|Placebo|Matched Placebo 4 to 6 hourly
1133362|NCT00478023|O4|Outcome|CG5503 100mg|CG5503 IR 100mg 4 to 6 hourly
1133363|NCT00478023|O3|Outcome|CG5503 75mg|CG5503 IR 75mg 4 to 6 hourly
1133364|NCT00478023|O2|Outcome|CG5503 50mg|CG5503 IR 50mg 4 to 6 hourly
1133365|NCT00478023|O1|Outcome|Morphine|Morphine IR 20mg 4-6 hourly
1133366|NCT00478023|O5|Outcome|Placebo|Matched Placebo 4 to 6 hourly
1133367|NCT00478023|O4|Outcome|CG5503 100mg|CG5503 IR 100mg 4 to 6 hourly
1133368|NCT00478023|O3|Outcome|CG5503 75mg|CG5503 IR 75mg 4 to 6 hourly
1133369|NCT00478023|O2|Outcome|CG5503 50mg|CG5503 IR 50mg 4 to 6 hourly
1133370|NCT00478023|O1|Outcome|Morphine|Morphine IR 20mg 4-6 hourly
1133371|NCT00478023|E5|Reported Event|Placebo|Matched Placebo 4 to 6 hourly
1133372|NCT00478023|E4|Reported Event|CG5503 100mg|CG5503 IR 100mg 4 to 6 hourly
1133373|NCT00478023|E3|Reported Event|CG5503 75mg|CG5503 IR 75mg 4 to 6 hourly
1133374|NCT00478023|E2|Reported Event|CG5503 50mg|CG5503 IR 50mg 4 to 6 hourly
1133375|NCT00478023|E1|Reported Event|Morphine|Morphine IR 20mg 4-6 hourly
1133376|NCT00477971|B3|Baseline|Total|Total of all reporting groups
1133377|NCT00477971|B2|Baseline|High-Dose Melphalan + Autologous HSC|Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
1133378|NCT00477971|B1|Baseline|Low-Dose Melphalan|Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
1133406|NCT00477672|P1|Participant Flow|Placebo|Placebo tablet, once daily by mouth, 6 weeks
1133741|NCT00477269|O1|Outcome|STI571|STI571
1133379|NCT00477971|P2|Participant Flow|High-Dose Melphalan + Autologous HSC|Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
1133380|NCT00477971|P1|Participant Flow|Low-Dose Melphalan|Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
1133381|NCT00477971|O2|Outcome|High-Dose Melphalan + Autologous HSC|Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
1133382|NCT00477971|O1|Outcome|Low-Dose Melphalan|Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
1133383|NCT00477971|O2|Outcome|High-Dose Melphalan + Autologous HSC|Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
1133384|NCT00477971|O1|Outcome|Low-Dose Melphalan|Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
1133385|NCT00477971|O2|Outcome|High-Dose Melphalan + Autologous HSC|Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
1133386|NCT00477971|O1|Outcome|Low-Dose Melphalan|Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
1133387|NCT00477971|O2|Outcome|High-Dose Melphalan + Autologous HSC|Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
1133388|NCT00477971|O1|Outcome|Low-Dose Melphalan|Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
1133425|NCT00477607|P2|Participant Flow|Placebo|"Receiving placebo during cisplatin treatment~Placebo supplements (1200mg once a day) were administered to each patient prior to first cisplatin treatment and continued until 3 months after last treatment."
1133389|NCT00477971|E2|Reported Event|High-Dose Melphalan + Autologous HSC|Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
1133390|NCT00477971|E1|Reported Event|Low-Dose Melphalan|Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
1133391|NCT00477750|B1|Baseline|Treatment (Lenalidomide, Melphalan, Prednisone)|"Intervention: Drug: lenalidomide 10 mg orally days 1-21 every 28 days until progression~Intervention: Drug: melphalan 5mg/m^2 orally days 1-4 every 28 days until progression~Intervention: Drug: prednisone 60mg/m^2, orally days 1-4 every 28 days until progression"
1133392|NCT00477750|P1|Participant Flow|Treatment (Lenalidomide, Melphalan, Prednisone)|"Intervention: Drug: lenalidomide 10 mg orally days 1-21 every 28 days until progression~Intervention: Drug: melphalan 5mg/m^2 orally days 1-4 every 28 days until progression~Intervention: Drug: prednisone 60mg/m^2, orally days 1-4 every 28 days until progression"
1133393|NCT00477750|O1|Outcome|Treatment (Lenalidomide, Melphalan, Prednisone)|"Intervention: Drug: lenalidomide 10 mg orally days 1-21 every 28 days until progression > > Intervention: Drug: melphalan 5mg/m^2 orally days 1-4 every 28 days until progression >~> Intervention: Drug: prednisone 60mg/m^2, orally days 1-4 every 28 days until progression"
1133394|NCT00477750|E1|Reported Event|Treatment (Lenalidomide, Melphalan, Prednisone)|"Intervention: Drug: lenalidomide 10 mg orally days 1-21 every 28 days until progression~Intervention: Drug: melphalan 5mg/m^2 orally days 1-4 every 28 days until progression~Intervention: Drug: prednisone 60mg/m^2, orally days 1-4 every 28 days until progression"
1133395|NCT00477685|B1|Baseline|OculusGen Collagen Matrix|OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.
1133396|NCT00477685|P1|Participant Flow|OculusGen Collagen Matrix|OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.
1133397|NCT00477685|O1|Outcome|OculusGen Collagen Matrix|OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.
1133398|NCT00477685|O1|Outcome|OculusGen Collagen Matrix|OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.
1133399|NCT00477685|E1|Reported Event|OculusGen Collagen Matrix|OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.
1133400|NCT00477672|B4|Baseline|Total|Total of all reporting groups
1133401|NCT00477672|B3|Baseline|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103) 40 mg, tablet, once daily by mouth, 6 weeks
1133402|NCT00477672|B2|Baseline|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
1133403|NCT00477672|B1|Baseline|Placebo|Placebo tablet, once daily by mouth, 6 weeks
1133404|NCT00477672|P3|Participant Flow|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103) 40 mg, tablet, once daily by mouth, 6 weeks
1133405|NCT00477672|P2|Participant Flow|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
1133407|NCT00477672|O3|Outcome|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103) 40 mg, tablet, once daily by mouth, 6 weeks
1133408|NCT00477672|O2|Outcome|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
1133409|NCT00477672|O1|Outcome|Placebo|Placebo tablet, once daily by mouth, 6 weeks
1133410|NCT00477672|O3|Outcome|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103) 40 mg, tablet, once daily by mouth, 6 weeks
1133411|NCT00477672|O2|Outcome|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
1133412|NCT00477672|O1|Outcome|Placebo|Placebo tablet, once daily by mouth, 6 weeks
1133413|NCT00477672|E3|Reported Event|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103) 40 mg, tablet, once daily by mouth, 6 weeks
1133414|NCT00477672|E2|Reported Event|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
1133415|NCT00477672|E1|Reported Event|Placebo|Placebo tablet, once daily by mouth, 6 weeks
1133416|NCT00477633|B1|Baseline|Norethindrone/Ethinyl Estradiol Tablets|1 tablet daily 0.8mg norethindrone(NE)/ 0.025 mg ethinyl estradiol (EE) tablets for 24 days of 28 day cycle followed by 4 days of placebo
1133417|NCT00477633|P1|Participant Flow|Norethindrone/Ethinyl Estradiol Tablets|1 tablet daily 0.8mg norethindrone(NE)/ 0.025 mg ethinyl estradiol (EE) tablets for 24 days of 28 day cycle followed by 4 days of placebo
1133418|NCT00477633|O1|Outcome|Norethindrone/Ethinyl Estradiol Tablets|1 tablet daily 0.8mg norethindrone(NE)/ 0.025 mg ethinyl estradiol (EE) tablets for 24 days of 28 day cycle followed by 4 days of placebo
1133419|NCT00477633|O1|Outcome|Norethindrone/Ethinyl Estradiol Tablets|1 tablet daily 0.8mg norethindrone(NE)/ 0.025 mg ethinyl estradiol (EE) tablets for 24 days of 28 day cycle followed by 4 days of placebo
1133420|NCT00477633|O1|Outcome|Norethindrone/Ethinyl Estradiol Tablets|1 tablet daily 0.8mg norethindrone(NE)/ 0.025 mg ethinyl estradiol (EE) tablets for 24 days of 28 day cycle followed by 4 days of placebo
1133421|NCT00477633|E1|Reported Event|Norethindrone/Ethinyl Estradiol Tablets|1 tablet daily 0.8mg norethindrone(NE)/ 0.025 mg ethinyl estradiol (EE) tablets for 24 days of 28 day cycle followed by 4 days of placebo
1133422|NCT00477607|B3|Baseline|Total|Total of all reporting groups
1133423|NCT00477607|B2|Baseline|Arm 2|"Receiving placebo during cisplatin treatment~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress."
1133424|NCT00477607|B1|Baseline|Arm 1|"Receiving alpha-lipoic acid during cisplatin treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges."
1133426|NCT00477607|P1|Participant Flow|Alpha-lipoic Acid|"Receiving alpha-lipoic acid during cisplatin treatment.~alpha-lipoic acid : Supplements (1200mg once a day) was administered to each patient prior to first cisplatin treatment and continued until 3 months after last treatment."
1133427|NCT00477607|O2|Outcome|Arm 2|"Receiving placebo during cisplatin treatment~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress."
1133428|NCT00477607|O1|Outcome|Arm 1|"Receiving alpha-lipoic acid during cisplatin treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges."
1133429|NCT00477607|O2|Outcome|Arm 2|"Receiving placebo during cisplatin treatment~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress."
1133430|NCT00477607|O1|Outcome|Arm 1|"Receiving alpha-lipoic acid during cisplatin treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges."
1133431|NCT00477607|O2|Outcome|Arm 2|"Receiving placebo during cisplatin treatment~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress."
1133432|NCT00477607|O1|Outcome|Arm 1|"Receiving alpha-lipoic acid during cisplatin treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges."
1133590|NCT00477490|E1|Reported Event|Part I: Placebo|Participants took a placebo ‘melt’ for 28 days to complete Part I of the study.
1133433|NCT00477607|E2|Reported Event|Arm 2|"Receiving placebo during cisplatin treatment~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress."
1133434|NCT00477607|E1|Reported Event|Arm 1|"Receiving alpha-lipoic acid during cisplatin treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges."
1133435|NCT00477594|B3|Baseline|Total|Total of all reporting groups
1133436|NCT00477594|B2|Baseline|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
1133437|NCT00477594|B1|Baseline|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
1133438|NCT00477594|P2|Participant Flow|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
1133439|NCT00477594|P1|Participant Flow|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
1133440|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
1133441|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
1133442|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
1133443|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
1133444|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
1133445|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
1133446|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
1133447|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
1133448|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
1133449|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
1133450|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
1133451|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
1133452|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
1133453|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
1133454|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
1133455|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
1133456|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
1133457|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
1133458|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
1133459|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
1133460|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
1133461|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
1133462|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
1133463|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
1133464|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
1133465|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
1133466|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
1133467|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
1133468|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
1133469|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
1133470|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
1133471|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
1133472|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
1133473|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
1133474|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
1133475|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
1133476|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
1133477|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
1133763|NCT00477230|E2|Reported Event|Standard Anti-arrhythmic Drug Therapy|Medication as prescribed by physician.
1133478|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
1133479|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
1133480|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
1133481|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
1133482|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
1133483|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
1133484|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
1133485|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
1133486|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
1133487|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
1133488|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
1133489|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
1133490|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
1133491|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
1133742|NCT00477269|O2|Outcome|Placebo|Placebo
1133743|NCT00477269|O1|Outcome|STI571|STI571
1133744|NCT00477269|O2|Outcome|Placebo|Placebo
1133492|NCT00477594|E2|Reported Event|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
1133493|NCT00477594|E1|Reported Event|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
1133494|NCT00477490|B6|Baseline|Total|Total of all reporting groups
1133495|NCT00477490|B5|Baseline|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133496|NCT00477490|B4|Baseline|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133497|NCT00477490|B3|Baseline|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133498|NCT00477490|B2|Baseline|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133499|NCT00477490|B1|Baseline|Placebo|Participants took a placebo ‘melt’ for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
1133500|NCT00477490|P9|Participant Flow|Placebo to 100 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
1133501|NCT00477490|P8|Participant Flow|Placebo to 50 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
1133502|NCT00477490|P7|Participant Flow|Placebo to 25 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
1133503|NCT00477490|P6|Participant Flow|Placebo to 10 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 10 μg once daily about an hour before bedtime.
1133504|NCT00477490|P5|Participant Flow|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133505|NCT00477490|P4|Participant Flow|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133764|NCT00477230|E1|Reported Event|Single Ablation Procedure With Endoscopic Ablation System|Single ablation procedure with Endoscopic Ablation System
1133765|NCT00477204|B3|Baseline|Total|Total of all reporting groups
1133506|NCT00477490|P3|Participant Flow|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133507|NCT00477490|P2|Participant Flow|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133508|NCT00477490|P1|Participant Flow|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133509|NCT00477490|O8|Outcome|Placebo to 100 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
1133510|NCT00477490|O7|Outcome|Placebo to 50 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
1133511|NCT00477490|O6|Outcome|Placebo to 25 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
1133512|NCT00477490|O5|Outcome|Placebo to 10 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 10 μg once daily about an hour before bedtime.
1133513|NCT00477490|O4|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133514|NCT00477490|O3|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133515|NCT00477490|O2|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133516|NCT00477490|O1|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133745|NCT00477269|O1|Outcome|STI571|STI571
1133517|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133518|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133519|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133520|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133521|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
1133522|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133523|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133524|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133525|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133526|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
1133527|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133528|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133529|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133766|NCT00477204|B2|Baseline|Zocor|simvastatin, ezetimibe/simvastatin : simvastatin 20 mg daiy ezetimibe/simvastatin 10/20 mg daily placebo for each medication
1134625|NCT00474630|O2|Outcome|Placebo|Placebo
1133530|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133531|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
1133532|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133533|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133534|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133535|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133536|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
1133537|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133538|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133539|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133639|NCT00477386|O1|Outcome|Phase II Dose Treatment|Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
1133540|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133541|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
1133542|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133543|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133544|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133545|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133546|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
1133547|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133548|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133549|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133550|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133551|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
1133552|NCT00477490|O8|Outcome|Placebo to 100 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
1133553|NCT00477490|O7|Outcome|Placebo to 50 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
1133767|NCT00477204|B1|Baseline|Vytorin|simvastatin, ezetimibe/simvastatin : simvastatin 20 mg daiy ezetimibe/simvastatin 10/20 mg daily placebo for each medication
1133554|NCT00477490|O6|Outcome|Placebo to 25 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
1133555|NCT00477490|O5|Outcome|Placebo to 10 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 10 μg once daily about an hour before bedtime.
1133556|NCT00477490|O4|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133557|NCT00477490|O3|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133558|NCT00477490|O2|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133559|NCT00477490|O1|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133560|NCT00477490|O8|Outcome|Placebo to 100 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
1133561|NCT00477490|O7|Outcome|Placebo to 50 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
1133562|NCT00477490|O6|Outcome|Placebo to 25 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
1133563|NCT00477490|O5|Outcome|Placebo to 10 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 10 μg once daily about an hour before bedtime.
1133708|NCT00477269|O2|Outcome|Placebo|Placebo
1133709|NCT00477269|O1|Outcome|STI571|STI571
1133564|NCT00477490|O4|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133565|NCT00477490|O3|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133566|NCT00477490|O2|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133567|NCT00477490|O1|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133568|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133569|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133570|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133571|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133572|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
1133573|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133574|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133575|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133576|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133577|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
1133578|NCT00477490|E13|Reported Event|Part II: Placebo to Desmopressin Melt 100 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
1133579|NCT00477490|E12|Reported Event|Part II: Placebo to Desmopressin Melt 50 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
1133580|NCT00477490|E11|Reported Event|Part II: Placebo to Desmopressin Melt 25 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
1133581|NCT00477490|E10|Reported Event|Part II: Placebo to Desmopressin Melt 10 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 10 μg once daily about an hour before bedtime
1133582|NCT00477490|E9|Reported Event|Part II: Desmopressin Melt 100 μg|Participants who took desmopressin melt 100 μg in Part I of the study continued on this dose in Part II which ran between Months 1-6 (until the database for Part I was locked and treatment was unblinded).
1133583|NCT00477490|E8|Reported Event|Part II: Desmopressin Melt 50 μg|Participants who took desmopressin melt 50 μg in Part I of the study continued on this dose in Part II which ran between Months 1-6 (until the database for Part I was locked and treatment was unblinded).
1133584|NCT00477490|E7|Reported Event|Part II: Desmopressin Melt 25 μg|Participants who took desmopressin melt 25 μg in Part I of the study continued on this dose in Part II which ran between Months 1-6 (until the database for Part I was locked and treatment was unblinded).
1133585|NCT00477490|E6|Reported Event|Part II: Desmopressin Melt 10 μg|Participants who took desmopressin melt 10 μg in Part I of the study continued on this dose in Part II which ran between Months 1-6 (until the database for Part I was locked and treatment was unblinded).
1133586|NCT00477490|E5|Reported Event|Part I: Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
1133587|NCT00477490|E4|Reported Event|Part I: Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study.
1133588|NCT00477490|E3|Reported Event|Part I: Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study.
1133589|NCT00477490|E2|Reported Event|Part I: Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study.
1133591|NCT00477464|B1|Baseline|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 milligrams (mg) once daily. Capecitabine was orally administered at 1000 mg per square meter (mg/m^2) twice daily on the first day through the fourteenth day of each 21-day cycle.
1133592|NCT00477464|P1|Participant Flow|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 milligrams (mg) once daily. Capecitabine was orally administered at 1000 mg per square meter (mg/m^2) twice daily on the first day through the fourteenth day of each 21-day cycle.
1133593|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
1133594|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
1133595|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
1133596|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
1133597|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
1133598|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|
1133599|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
1133600|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
1133601|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
1133602|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
1133603|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
1133604|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
1133768|NCT00477204|P2|Participant Flow|Simvastatin|"simvastatin: simvastatin 20 mg daily~placebo for each medication"
1133605|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
1133606|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
1133607|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
1133608|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
1133609|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
1133610|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
1133611|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
1133612|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 milligrams (mg) once daily. Capecitabine was orally administered at 1000 mg per square meter (mg/m^2) twice daily on the first day through the fourteenth day of each 21-day cycle.
1133613|NCT00477464|E1|Reported Event|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 milligrams (mg) once daily. Capecitabine was orally administered at 1000 mg per square meter (mg/m^2) twice daily on the first day through the fourteenth day of each 21-day cycle.
1133614|NCT00477451|B5|Baseline|Total|Total of all reporting groups
1133710|NCT00477269|O2|Outcome|Placebo|Placebo
1133711|NCT00477269|O1|Outcome|STI571|STI571
1133615|NCT00477451|B4|Baseline|Initial Inhaled Alprazolam 2 mg|"Subjects received 2 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the initial open label dose assessment~Inhaled alprazolam 2 mg: Inhaled Staccato Alprazolam 2 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
1133616|NCT00477451|B3|Baseline|Open Label Inhaled Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the open label dose validation~Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
1133617|NCT00477451|B2|Baseline|RCT Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial~Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
1133618|NCT00477451|B1|Baseline|RCT Placebo|"Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial~Inhaled placebo: Inhaled Staccato Alprazolam Placebo~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
1133619|NCT00477451|P4|Participant Flow|Initial Inhaled Alprazolam 2 mg|"Subjects received 2 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the initial open label dose assessment~Inhaled alprazolam 2 mg: Inhaled Staccato Alprazolam 2 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
1133620|NCT00477451|P3|Participant Flow|Open Label Inhaled Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the open label dose validation~Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
1133621|NCT00477451|P2|Participant Flow|RCT Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial~Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
1133622|NCT00477451|P1|Participant Flow|RCT Placebo|"Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial~Inhaled placebo: Inhaled Staccato Alprazolam Placebo~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
1133623|NCT00477451|O2|Outcome|RCT Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial~Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
1133624|NCT00477451|O1|Outcome|RCT Placebo|"Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial~Inhaled placebo: Inhaled Staccato Alprazolam Placebo~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
1133625|NCT00477451|O2|Outcome|RCT Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial~Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
1133626|NCT00477451|O1|Outcome|RCT Placebo|"Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial~Inhaled placebo: Inhaled Staccato Alprazolam Placebo~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
1133627|NCT00477451|O2|Outcome|RCT Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial~Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
1133769|NCT00477204|P1|Participant Flow|Ezetimibe/Simvastatin|ezetimibe/simvastatin : ezetimibe/simvastatin 10/20 mg daily placebo for each medication
1134626|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
1133628|NCT00477451|O1|Outcome|RCT Placebo|"Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial~Inhaled placebo: Inhaled Staccato Alprazolam Placebo~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
1133629|NCT00477451|E4|Reported Event|Initial Inhaled Alprazolam 2 mg|"Subjects received 2 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the initial open label dose assessment~Inhaled alprazolam 2 mg: Inhaled Staccato Alprazolam 2 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
1133630|NCT00477451|E3|Reported Event|Open Label Inhaled Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the open label dose validation~Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
1133631|NCT00477451|E2|Reported Event|RCT Alprazolam 1 mg|"Subjects received 1 mg inhaled Staccato alprazolam 10 s after 0.5 mg/kg doxapram IV in the randomized controlled trial~Inhaled alprazolam 1 mg: Inhaled Staccato Alprazolam 1 mg~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
1133632|NCT00477451|E1|Reported Event|RCT Placebo|"Subjects received inhaled placebo after 0.5 mg/kg doxapram IV in the randomized controlled trial~Inhaled placebo: Inhaled Staccato Alprazolam Placebo~IV doxapram: 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo"
1133633|NCT00477386|B3|Baseline|Total|Total of all reporting groups
1133634|NCT00477386|B2|Baseline|Phase II|Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
1133635|NCT00477386|B1|Baseline|Phase I Dose Finding|Decitabine at escalating dose levels will be given IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
1133636|NCT00477386|P2|Participant Flow|Phase II|Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
1133637|NCT00477386|P1|Participant Flow|Phase I Dose Finding|Decitabine at escalating dose levels will be given IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
1133638|NCT00477386|O1|Outcome|Phase II Dose Treatment|Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
1133712|NCT00477269|O2|Outcome|Placebo|Placebo
1133640|NCT00477386|O1|Outcome|Phase II Dose Treatment|Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
1133641|NCT00477386|O1|Outcome|Phase I Dose Finding|Decitabine at escalating dose levels will be given IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
1133642|NCT00477386|E2|Reported Event|Phase II|Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
1133643|NCT00477386|E1|Reported Event|Phase I Dosing Finding|Decitabine at escalating dose levels will be given IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
1133644|NCT00477334|B3|Baseline|Total|Total of all reporting groups
1133645|NCT00477334|B2|Baseline|Placebo Comparator|Placebo twice a day for one day for treatment.
1133646|NCT00477334|B1|Baseline|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
1133647|NCT00477334|P2|Participant Flow|Placebo Comparator|Placebo twice a day for one day for treatment.
1133648|NCT00477334|P1|Participant Flow|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
1133649|NCT00477334|O4|Outcome|Grade 4 Toxicity|
1133650|NCT00477334|O3|Outcome|Grade 3 Toxicity|
1133651|NCT00477334|O2|Outcome|Grade 2 Toxicity|
1133652|NCT00477334|O1|Outcome|Grade 1 Toxicity|
1133653|NCT00477334|O4|Outcome|Grade 4 Toxicity|
1133654|NCT00477334|O3|Outcome|Grade 3 Toxicity|
1133655|NCT00477334|O2|Outcome|Grade 2 Toxicity|
1133656|NCT00477334|O1|Outcome|Grade 1 Toxicity|
1133657|NCT00477334|O2|Outcome|Placebo Comparator|Placebo twice a day for one day for treatment.
1133658|NCT00477334|O1|Outcome|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
1133659|NCT00477334|O2|Outcome|Placebo Comparator|Placebo twice a day for one day for treatment.
1133660|NCT00477334|O1|Outcome|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
1133661|NCT00477334|O2|Outcome|Placebo Comparator|Placebo twice a day for one day for treatment.
1133662|NCT00477334|O1|Outcome|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
1133663|NCT00477334|O2|Outcome|Placebo Comparator|Placebo twice a day for one day for treatment.
1133664|NCT00477334|O1|Outcome|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
1133665|NCT00477334|O2|Outcome|Placebo Comparator|Placebo twice a day for one day for treatment.
1133666|NCT00477334|O1|Outcome|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
1133667|NCT00477334|O2|Outcome|Placebo Comparator|Placebo twice a day for one day for treatment.
1133668|NCT00477334|O1|Outcome|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
1133669|NCT00477334|E2|Reported Event|Placebo Comparator|Placebo twice a day for one day for treatment.
1133670|NCT00477334|E1|Reported Event|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
1133671|NCT00477295|B3|Baseline|Total|Total of all reporting groups
1133770|NCT00477204|O2|Outcome|Zocor (Simvastatin)|"simvastatin: simvastatin 20 mg daily~placebo for each medication"
1133771|NCT00477204|O1|Outcome|Vytorin (Ezetimibe/Simvastatin)|ezetimibe/simvastatin : ezetimibe/simvastatin 10/20 mg daily placebo for each medication
1133772|NCT00477204|E2|Reported Event|Zocor [Simvastatin]|Zocor [simvastatin] 20 mg taken daily for 6 months to compare in a 2- arm design to Vytorin [simvastatin + ezetimibe].
1133672|NCT00477295|B2|Baseline|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
1133673|NCT00477295|B1|Baseline|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP(the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
1133674|NCT00477295|P2|Participant Flow|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
1133675|NCT00477295|P1|Participant Flow|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
1133676|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
1133713|NCT00477269|O1|Outcome|STI571|STI571
1133677|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
1133678|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
1133679|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
1133680|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
1133681|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
1133682|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
1133683|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
1133773|NCT00477204|E1|Reported Event|Vytorin (Simvastatin + Ezetimibe)|Vytorin [simvastatin + ezetimibe]20 mg taken daily for 6 months to compare in a 2- arm design to Zocor [simvastatin] .
1133684|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
1133685|NCT00477295|O1|Outcome|Zonisamide|"The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily.~During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP."
1133686|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
1133687|NCT00477295|O1|Outcome|Zonisamide|"The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily.~During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP."
1133688|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
1133689|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
1133690|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
1133691|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
1133692|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
1133693|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
1133694|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
1133695|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP(the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
1133774|NCT00477191|B1|Baseline|Etanercept|"Etanercept~Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and then 50 mg once a week for 3 months."
1134627|NCT00474630|O2|Outcome|Placebo|Placebo
1133696|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
1133697|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP(the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
1133698|NCT00477295|E2|Reported Event|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
1133699|NCT00477295|E1|Reported Event|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
1133700|NCT00477269|B3|Baseline|Total|Total of all reporting groups
1133701|NCT00477269|B2|Baseline|Placebo|Placebo
1133702|NCT00477269|B1|Baseline|STI571|STI571
1133703|NCT00477269|P3|Participant Flow|All Patients|Open label extension
1133704|NCT00477269|P2|Participant Flow|Placebo|Placebo
1133705|NCT00477269|P1|Participant Flow|STI571|STI571
1133706|NCT00477269|O2|Outcome|Placebo|Placebo
1133707|NCT00477269|O1|Outcome|STI571|STI571
1133746|NCT00477269|O2|Outcome|Placebo|Placebo
1133747|NCT00477269|O1|Outcome|STI571|STI571
1133748|NCT00477269|O2|Outcome|Placebo|Placebo
1133749|NCT00477269|O1|Outcome|STI571|STI571
1133750|NCT00477269|O1|Outcome|All Patients|Open label extension
1133751|NCT00477269|O2|Outcome|Placebo|Placebo
1133752|NCT00477269|O1|Outcome|STI571|STI571
1133753|NCT00477269|E3|Reported Event|Extension - STI571|Extension - STI571
1133754|NCT00477269|E2|Reported Event|Core - Placebo|Core - Placebo
1133755|NCT00477269|E1|Reported Event|Core - STI571|Core - STI571
1133756|NCT00477230|B3|Baseline|Total|Total of all reporting groups
1133757|NCT00477230|B2|Baseline|Standard Anti-arrhythmic Drug Therapy|Medication as prescribed by physician.
1133758|NCT00477230|B1|Baseline|Single Ablation Procedure With Endoscopic Ablation System|Single ablation procedure with Endoscopic Ablation System
1133759|NCT00477230|P2|Participant Flow|Standard Anti-arrhythmic Drug Therapy|Medication as prescribed by physician.
1133760|NCT00477230|P1|Participant Flow|Single Ablation Procedure With Endoscopic Ablation System|Single ablation procedure with Endoscopic Ablation System
1133761|NCT00477230|O2|Outcome|Standard Anti-arrhythmic Drug Therapy|Medication as prescribed by physician.
1133762|NCT00477230|O1|Outcome|Single Ablation Procedure With Endoscopic Ablation System|Single ablation procedure with Endoscopic Ablation System
1140882|NCT00460239|O5|Outcome|Buprenorphine 16 mg|
1133775|NCT00477191|P1|Participant Flow|Etanercept|"Etanercept~Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months."
1133776|NCT00477191|O1|Outcome|Etanercept|"Etanercept~Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months."
1133777|NCT00477191|O1|Outcome|Etanercept|"Etanercept~Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months."
1133778|NCT00477191|O1|Outcome|Etanercept|"Etanercept~Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months."
1133779|NCT00477191|O1|Outcome|Etanercept|"Etanercept~Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months."
1133780|NCT00477191|E1|Reported Event|Etanercept|"Etanercept~Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months."
1133781|NCT00477165|B3|Baseline|Total|Total of all reporting groups
1133782|NCT00477165|B2|Baseline|Placebo|Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
1133783|NCT00477165|B1|Baseline|Cialopram|One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks
1133784|NCT00477165|P2|Participant Flow|Placebo|Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
1133785|NCT00477165|P1|Participant Flow|Cialopram|One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks
1133786|NCT00477165|O2|Outcome|Placebo|Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
1133787|NCT00477165|O1|Outcome|Citalopram|One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks
1133788|NCT00477165|O2|Outcome|Placebo|Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
1133789|NCT00477165|O1|Outcome|Citalopram|One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks
1133790|NCT00477165|O2|Outcome|Placebo|Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
1133791|NCT00477165|O1|Outcome|Citalopram|One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks
1133792|NCT00477165|O2|Outcome|Placebo|Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
1133793|NCT00477165|O1|Outcome|Citalopram|One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks
1133794|NCT00477165|E2|Reported Event|Placebo|Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
1133795|NCT00477165|E1|Reported Event|Citalopram|One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks
1133796|NCT00477152|B1|Baseline|HYLENEX-augmented Subcutaneous (SC) Rehydration|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
1133797|NCT00477152|P1|Participant Flow|HYLENEX-augmented Subcutaneous (SC) Rehydration|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
1133798|NCT00477152|O1|Outcome|HYLENEX-augmented Subcutaneous (SC) Rehydration|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
1133799|NCT00477152|O1|Outcome|HYLENEX-augmented Subcutaneous (SC) Rehydration|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
1133800|NCT00477152|O1|Outcome|HYLENEX-augmented Subcutaneous (SC) Rehydration|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
1133801|NCT00477152|O1|Outcome|HYLENEX-augmented Subcutaneous (SC) Rehydration|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
1133802|NCT00477152|E1|Reported Event|HYLENEX-augmented Subcutaneous (SC) Rehydration|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
1133803|NCT00476957|B3|Baseline|Total|Total of all reporting groups
1133804|NCT00476957|B2|Baseline|C-SES|"Cordis Cypher® Sirolimus-eluting Coronary Stent~Stent : Stent implantation"
1133948|NCT00476008|O1|Outcome|Placebo|Placebo : Placebo BID for 12 months
1133805|NCT00476957|B1|Baseline|E-ZES|"Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System~Stent : Stent implantation"
1133806|NCT00476957|P2|Participant Flow|C-SES|"Cordis Cypher® Sirolimus-eluting Coronary Stent~Stent : Stent implantation"
1133807|NCT00476957|P1|Participant Flow|E-ZES|"Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System~Stent : Stent implantation"
1133808|NCT00476957|O2|Outcome|C-SES|"Cordis Cypher® Sirolimus-eluting Coronary Stent~Stent : Stent implantation"
1133809|NCT00476957|O1|Outcome|E-ZES|"Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System~Stent : Stent implantation"
1133810|NCT00476957|O2|Outcome|C-SES|"Cordis Cypher® Sirolimus-eluting Coronary Stent~Stent : Stent implantation"
1133811|NCT00476957|O1|Outcome|E-ZES|"Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System~Stent : Stent implantation"
1133812|NCT00476957|E2|Reported Event|C-SES|"Cordis Cypher® Sirolimus-eluting Coronary Stent~Stent : Stent implantation"
1133813|NCT00476957|E1|Reported Event|E-ZES|"Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System~Stent : Stent implantation"
1133814|NCT00476827|B7|Baseline|Total|Total of all reporting groups
1133815|NCT00476827|B6|Baseline|Bevacizumab / Gemcitabine|Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.
1133816|NCT00476827|B5|Baseline|Bevacizumab /Vinorelbine Tartrate|Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
1140883|NCT00460239|O4|Outcome|Buprenorphine 8 mg|
1133817|NCT00476827|B4|Baseline|Bevacizumab / Paclitaxel|Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
1133818|NCT00476827|B3|Baseline|Bevacizumab / CPT-11|CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
1133819|NCT00476827|B2|Baseline|Bevacizumab / Docetaxel|Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
1133820|NCT00476827|B1|Baseline|Bevacizumab / Capecitabine|Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle.
1133821|NCT00476827|P6|Participant Flow|Bevacizumab / Gemcitabine|Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.
1133822|NCT00476827|P5|Participant Flow|Bevacizumab /Vinorelbine Tartrate|Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
1133823|NCT00476827|P4|Participant Flow|Bevacizumab / Paclitaxel|Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
1133824|NCT00476827|P3|Participant Flow|Bevacizumab / Irinotecan (Camptosar®, CPT-11)|CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
1133825|NCT00476827|P2|Participant Flow|Bevacizumab / Docetaxel|Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
1133826|NCT00476827|P1|Participant Flow|Bevacizumab / Capecitabine|Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle.
1133827|NCT00476827|O6|Outcome|Bevacizumab / Gemcitabine|Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.
1133828|NCT00476827|O5|Outcome|Bevacizumab /Vinorelbine Tartrate|Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
1133829|NCT00476827|O4|Outcome|Bevacizumab / Paclitaxel|Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
1133830|NCT00476827|O3|Outcome|Bevacizumab / CPT-11|CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
1133831|NCT00476827|O2|Outcome|Bevacizumab / Docetaxel|Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
1133832|NCT00476827|O1|Outcome|Bevacizumab / Capecitabine|Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle.
1133833|NCT00476827|O6|Outcome|Bevacizumab / Gemcitabine|Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.
1133834|NCT00476827|O5|Outcome|Bevacizumab /Vinorelbine Tartrate|Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
1133835|NCT00476827|O4|Outcome|Bevacizumab / Paclitaxel|Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
1133836|NCT00476827|O3|Outcome|Bevacizumab / CPT-11|CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
1133837|NCT00476827|O2|Outcome|Bevacizumab / Docetaxel|Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
1133838|NCT00476827|O1|Outcome|Bevacizumab / Capecitabine|Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle.
1133839|NCT00476827|O6|Outcome|Bevacizumab / Gemcitabine|Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.
1133840|NCT00476827|O5|Outcome|Bevacizumab /Vinorelbine Tartrate|Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
1133841|NCT00476827|O4|Outcome|Bevacizumab / Paclitaxel|Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
1133842|NCT00476827|O3|Outcome|Bevacizumab / CPT-11|CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
1133843|NCT00476827|O2|Outcome|Bevacizumab / Docetaxel|Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
1133844|NCT00476827|O1|Outcome|Bevacizumab / Capecitabine|Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle.
1133845|NCT00476827|O6|Outcome|Bevacizumab / Gemcitabine|Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.
1133846|NCT00476827|O5|Outcome|Bevacizumab /Vinorelbine Tartrate|Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
1133847|NCT00476827|O4|Outcome|Bevacizumab / Paclitaxel|Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
1133884|NCT00476476|B2|Baseline|Erlotinib-Cohort 2|Patients rcvd oral erlotinib 150 mg/day. Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.
1133848|NCT00476827|O3|Outcome|Bevacizumab / CPT-11|CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
1133849|NCT00476827|O2|Outcome|Bevacizumab / Docetaxel|Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
1133850|NCT00476827|O1|Outcome|Bevacizumab / Capecitabine|Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle.
1133851|NCT00476827|E4|Reported Event|Avastin (Bevacizumab)/Navelbine (Vinorelbine Tartrate)|
1133852|NCT00476827|E3|Reported Event|Avastin (Bevacizumab)/Gemzar(Gemcitabine,Difluorodeoxycytidine|
1133853|NCT00476827|E2|Reported Event|Avastin (Bevacizumab) / Camptosar (CPT 11/ Irinotecan)|
1133854|NCT00476827|E1|Reported Event|Avastin (Bevacizumab)/ Capecitabine (Xeloda)|
1133855|NCT00476788|B1|Baseline|Omnipod Device|Patients will be placed on an Omnipod insulin pump
1133856|NCT00476788|P1|Participant Flow|Omnipod Device|Patients will be placed on an Omnipod insulin pump
1133857|NCT00476788|O1|Outcome|Omnipod Device|Patients will be placed on an Omnipod insulin pump
1133858|NCT00476788|O1|Outcome|Omnipod Device|Patients will be placed on an Omnipod insulin pump
1133859|NCT00476788|E1|Reported Event|Omnipod Device|Patients will be placed on an Omnipod insulin pump
1133860|NCT00476645|B1|Baseline|Fulvestrant 250 mg|IM fulvestrant (250 mg) day 1 & day 14 of 1st month, then monthly
1133861|NCT00476645|P1|Participant Flow|Fulvestrant 250 mg|IM fulvestrant (250 mg) day 1 & day 14 of 1st month, then monthly
1133862|NCT00476645|O1|Outcome|Fulvestrant 250 mg|IM fulvestrant (250 mg) day 1 & day 14 of 1st month, then monthly
1133863|NCT00476645|O1|Outcome|Fulvestrant 250 mg|IM fulvestrant (250 mg) day 1 & day 14 of 1st month, then monthly
1133864|NCT00476645|O1|Outcome|Fulvestrant 250 mg|IM fulvestrant (250 mg) day 1 & day 14 of 1st month, then monthly
1133865|NCT00476645|E1|Reported Event|Fulvestrant 250 mg|IM fulvestrant (250 mg) day 1 & day 14 of 1st month, then monthly
1133866|NCT00476593|B5|Baseline|Total|Total of all reporting groups
1133867|NCT00476593|B4|Baseline|Healthy Volunteers|Healthy volunteers recruited from students and staff at St Olavs University hospital and NTU went through an opthalmologic examination and OCT scans were taken of their both eyes. This groups was to serve as healthy controls and as matching normative data for patients
1133868|NCT00476593|B3|Baseline|Patients With Anterior Uveitis|Patients with anterior uveitis were recruited from the Department of Ophthalmology. They were treated for their uveitis and OCT scans of their both eyes were taken on follow up.
1133869|NCT00476593|B2|Baseline|B Dexamethasone|Benzalkonium-reserved Dexamethasone Sodium Phosphate 0.1% was applied in one consecutively assigned eye of healthy volunteers six times a day for three days, after which macular thickness was assessed in both subjects's eyes with the OCT.
1133870|NCT00476593|B1|Baseline|A Diclofenac|Preservative- free Diclofenac Na 0.1 % eye drops were applied in one consecutively assigned eye of healthy volunteers four times a day for three days, after which macular thichness was measured in both subjects' eyes with the OCT .
1133871|NCT00476593|P4|Participant Flow|Healthy Volunteers|Healthy volunteers recruited from students and staff at St Olavs University hospital and NTU went through an opthalmologic examination and OCT scans were taken of their both eyes. This groups was to serve as healthy controls and as matching normative data for patients
1133872|NCT00476593|P3|Participant Flow|Patients With Anterior Uveitis|Patients with anterior uveitis were recruited from the Department of Ophthalmology. They were treated for their uveitis and OCT scans of their both eyes were taken on follow up.
1133873|NCT00476593|P2|Participant Flow|B Dexamethasone|Benzalkonium-reserved Dexamethasone Sodium Phosphate 0.1% was applied in one consecutively assigned eye of healthy volunteers six times a day for three days, after which macular thickness was assessed in both subjects's eyes with the OCT.
1133874|NCT00476593|P1|Participant Flow|A Diclofenac|Preservative- free Diclofenac Na 0.1 % eye drops were applied in one consecutively assigned eye of healthy volunteers four times a day for three days, after which macular thichness was measured in both subjects' eyes with the OCT .
1133875|NCT00476593|O4|Outcome|Healthy Volunteers|Healthy volunteers recruited from students and staff at St Olavs University hospital and NTU went through an opthalmologic examination and OCT scans were taken of their both eyes. This groups was to serve as healthy controls and as matching normative data for patients
1133876|NCT00476593|O3|Outcome|Patients With Anterior Uveitis|Patients with anterior uveitis were recruited from the Department of Ophthalmology. They were treated for their uveitis and OCT scans of their both eyes were taken on follow up.
1133877|NCT00476593|O2|Outcome|B Dexamethasone|Benzalkonium-reserved Dexamethasone Sodium Phosphate 0.1% was applied in one consecutively assigned eye of healthy volunteers six times a day for three days, after which macular thickness was assessed in both subjects's eyes with the OCT.
1133878|NCT00476593|O1|Outcome|A Diclofenac|Preservative- free Diclofenac Na 0.1 % eye drops were applied in one consecutively assigned eye of healthy volunteers four times a day for three days, after which macular thichness was measured in both subjects' eyes with the OCT .
1133879|NCT00476593|E4|Reported Event|Healthy Volunteers|Healthy volunteers recruited from students and staff at St Olavs University hospital and NTU went through an opthalmologic examination and OCT scans were taken of their both eyes. This groups was to serve as healthy controls and as matching normative data for patients
1133880|NCT00476593|E3|Reported Event|Patients With Anterior Uveitis|Patients with anterior uveitis were recruited from the Department of Ophthalmology. They were treated for their uveitis and OCT scans of their both eyes were taken on follow up.
1133881|NCT00476593|E2|Reported Event|B Dexamethasone|Benzalkonium-reserved Dexamethasone Sodium Phosphate 0.1% was applied in one consecutively assigned eye of healthy volunteers six times a day for three days, after which macular thickness was assessed in both subjects's eyes with the OCT.
1133882|NCT00476593|E1|Reported Event|A Diclofenac|Preservative- free Diclofenac Na 0.1 % eye drops were applied in one consecutively assigned eye of healthy volunteers four times a day for three days, after which macular thichness was measured in both subjects' eyes with the OCT .
1133883|NCT00476476|B3|Baseline|Total|Total of all reporting groups
1134628|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
1133885|NCT00476476|B1|Baseline|Erlotinib-Cohort 1|Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Two potential dose reductions were prescribed to 100 and 50 mg/day.
1133886|NCT00476476|P2|Participant Flow|Erlotinib-Cohort 2|Patients rcvd oral erlotinib 150 mg/day. Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.
1133887|NCT00476476|P1|Participant Flow|Erlotinib-Cohort 1|Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Two potential dose reductions were prescribed to 100 and 50 mg/day.
1133888|NCT00476476|O2|Outcome|Erlotinib-Cohort 2|Patients rcvd oral erlotinib 150 mg/day. Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.
1133889|NCT00476476|O1|Outcome|Erlotinib-Cohort 1|Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Two potential dose reductions were prescribed to 100 and 50 mg/day.
1133890|NCT00476476|E1|Reported Event|Erlotinib|Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.
1133891|NCT00476242|B3|Baseline|Total|Total of all reporting groups
1133892|NCT00476242|B2|Baseline|Placebo and Vivitrol|"intramuscular injection of Vivitrol 380 mg and Placebo~Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)"
1133893|NCT00476242|B1|Baseline|Memantine and Vivitrol|"intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO)~Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)~memantine: Memantine will be given in two divided doses, starting with the second day of the naltrexone induction, with the target doses of 40 mg/day (or the maximum tolerated dose), for a total of twelve weeks of medication treatment."
1133894|NCT00476242|P2|Participant Flow|Memantine and Vivitrol|Participants treated with memantine 40 mg/d capsules and Vivitrol.
1133895|NCT00476242|P1|Participant Flow|Placebo and Vivitrol|Participants treated with placebo capsules and Vivitrol.
1133896|NCT00476242|O2|Outcome|Placebo and Vivitrol|"intramuscular injection of Vivitrol 380 mg and Placebo~Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)"
1133897|NCT00476242|O1|Outcome|Memantine and Vivitrol|"intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO)~Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)~memantine: Memantine will be given in two divided doses, starting with the second day of the naltrexone induction, with the target doses of 40 mg/day (or the maximum tolerated dose), for a total of twelve weeks of medication treatment."
1133898|NCT00476242|O2|Outcome|Placebo and Vivitrol|"intramuscular injection of Vivitrol 380 mg and Placebo~Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)"
1133899|NCT00476242|O1|Outcome|Memantine and Vivitrol|"intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO)~Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)~memantine: Memantine will be given in two divided doses, starting with the second day of the naltrexone induction, with the target doses of 40 mg/day (or the maximum tolerated dose), for a total of twelve weeks of medication treatment."
1133900|NCT00476242|E2|Reported Event|Placebo and Vivitrol|"intramuscular injection of Vivitrol 380 mg and Placebo~Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)"
1133901|NCT00476242|E1|Reported Event|Memantine and Vivitrol|"intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO)~Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)~memantine: Memantine will be given in two divided doses, starting with the second day of the naltrexone induction, with the target doses of 40 mg/day (or the maximum tolerated dose), for a total of twelve weeks of medication treatment."
1133902|NCT00476229|B1|Baseline|Radiation + Chemotherapy + BSCT|Total Lymphoid Irradiation (2 times) at 80 cGy daily for five days + Thymoglobulin 1.5 mg/kg intravenous 5 days + Rituximab 375 mg/m^2 intravenous on 4 different days + Blood stem cell transplant (BSCT)
1133903|NCT00476229|P1|Participant Flow|Radiation + Chemotherapy + BSCT|Total Lymphoid Irradiation (2 times) at 80 cGy daily for five days + Thymoglobulin 1.5 mg/kg intravenous 5 days + Rituximab 375 mg/m^2 intravenous on 4 different days + Blood stem cell transplant (BSCT)
1133904|NCT00476229|O1|Outcome|Radiation + Chemotherapy + BSCT|Total Lymphoid Irradiation (2 times) at 80 cGy daily for five days + Thymoglobulin 1.5 mg/kg intravenous 5 days + Rituximab 375 mg/m^2 intravenous on 4 different days + Blood stem cell transplant (BSCT)
1133905|NCT00476229|E1|Reported Event|Radiation + Chemotherapy + BSCT|Total Lymphoid Irradiation (2 times) at 80 cGy daily for five days + Thymoglobulin 1.5 mg/kg intravenous 5 days + Rituximab 375 mg/m^2 intravenous on 4 different days + Blood stem cell transplant (BSCT)
1133906|NCT00476151|B3|Baseline|Total|Total of all reporting groups
1133907|NCT00476151|B2|Baseline|Amitriptyline 4% Ketamine 2% Cream|active topical cream applied twice daily for 4 weeks
1133908|NCT00476151|B1|Baseline|Placebo Cream|vehicle cream applied twice daily for 4 weeks
1133909|NCT00476151|P2|Participant Flow|Amitriptyline 4% Ketamine 2% Cream|active topical cream applied twice daily for 4 weeks
1133910|NCT00476151|P1|Participant Flow|Placebo Cream|vehicle cream applied twice daily for 4 weeks
1133911|NCT00476151|O2|Outcome|Amitriptyline 4% Ketamine 2% Cream|active topical cream applied twice daily for 4 weeks
1133912|NCT00476151|O1|Outcome|Placebo Cream|vehicle cream applied twice daily for 4 weeks
1133913|NCT00476151|E2|Reported Event|Amitriptyline 4% Ketamine 2% Cream|active topical cream applied twice daily for 4 weeks
1133914|NCT00476151|E1|Reported Event|Placebo Cream|vehicle cream applied twice daily for 4 weeks
1133966|NCT00475904|B3|Baseline|Placebo Cream and Capsules|placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily
1133967|NCT00475904|B2|Baseline|Gabapentin Capsules, Placebo Cream|oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily
1133915|NCT00476086|B1|Baseline|Oxaliplatin/ Gemcitabine Then Radiation|"Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.~on"
1133916|NCT00476086|P1|Participant Flow|Oxaliplatin/ Gemcitabine Then Radiation|Patients received IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
1133917|NCT00476086|O1|Outcome|Oxaliplatin/ Gemcitabine Then Radiation|Patients received IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
1133918|NCT00476086|O1|Outcome|Oxaliplatin/ Gemcitabine Then Radiation|Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
1133919|NCT00476086|E2|Reported Event|Radiation|On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
1133920|NCT00476086|E1|Reported Event|Oxaliplatin/ Gemcitabine|Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted.
1133921|NCT00476021|B3|Baseline|Total|Total of all reporting groups
1133922|NCT00476021|B2|Baseline|Delayed IUD Insertion (6-8 Weeks After Delivery)|"delayed IUD insertion (6-8 weeks after delivery)~Levonorgestrel-releasing IUD (Mirena): levonorgestrel-releasing IUD containing 52 mg levonorgestrel, indicated for use for up to 5 years"
1133923|NCT00476021|B1|Baseline|Immediate Postplacental IUD Insertion|"immediate postplacental IUD insertion~Levonorgestrel-releasing IUD (Mirena): levonorgestrel-releasing IUD containing 52 mg levonorgestrel, indicated for use for up to 5 years"
1133924|NCT00476021|P2|Participant Flow|Delayed IUD Insertion|Delayed LNG-IUD insertion
1133925|NCT00476021|P1|Participant Flow|Postplacental IUD Insertion|Postplacental LNG-IUD insertion
1133926|NCT00476021|O2|Outcome|Follow-up for IUD Insertion for Ineligible Participants|Ineligible participants were followed for 6 months to evaluate whether they received an IUD from their ob/gyn
1133927|NCT00476021|O1|Outcome|Pregnancy Within 6 Months for Ineligible Participants|If a participant was found to be ineligible as a result of postenrollment criteria, she was instructed to follow up with her primary obstetrician or midwife for postpartum contraception and delayed IUD insertion
1133928|NCT00476021|O2|Outcome|Delayed IUD Insertion|Infection after delayed LNG-IUD insertion
1133929|NCT00476021|O1|Outcome|Postplacental IUD Insertion|Infection after postplacental LNG-IUD insertion
1133930|NCT00476021|O2|Outcome|Delayed IUD Insertion|Delayed LNG-IUD insertion
1133931|NCT00476021|O1|Outcome|Postplacental IUD Insertion|Postplacental LNG-IUD insertion
1133932|NCT00476021|O1|Outcome|Delayed IUD Insertion|Followed up for delayed IUD insertion
1133933|NCT00476021|O1|Outcome|Received Postplacental IUD|Received postplacental LNG-IUD
1133934|NCT00476021|O2|Outcome|Delayed IUD Insertion|Delayed LNG-IUD insertion
1133935|NCT00476021|O1|Outcome|Postplacental IUD Insertion|Postplacental LNG-IUD insertion
1133936|NCT00476021|E2|Reported Event|Delayed IUD Insertion|Delayed LNG-IUD insertion
1133937|NCT00476021|E1|Reported Event|Postplacental IUD Insertion|Postplacental LNG-IUD insertion
1133938|NCT00476008|B3|Baseline|Total|Total of all reporting groups
1133939|NCT00476008|B2|Baseline|Placebo|Placebo : Placebo BID for 12 months
1133940|NCT00476008|B1|Baseline|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
1133941|NCT00476008|P2|Participant Flow|Placebo|Placebo : Placebo BID for 12 months
1133942|NCT00476008|P1|Participant Flow|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
1133943|NCT00476008|O2|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
1133944|NCT00476008|O1|Outcome|Placebo|Placebo : Placebo BID for 12 months
1133945|NCT00476008|O2|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
1133946|NCT00476008|O1|Outcome|Placebo|Placebo : Placebo BID for 12 months
1133947|NCT00476008|O2|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
1133949|NCT00476008|O2|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
1133950|NCT00476008|O1|Outcome|Placebo|Placebo : Placebo BID for 12 months
1133951|NCT00476008|O2|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
1133952|NCT00476008|O1|Outcome|Placebo|Placebo : Placebo BID for 12 months
1133953|NCT00476008|O2|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
1133954|NCT00476008|O1|Outcome|Placebo|Placebo : Placebo BID for 12 months
1133955|NCT00476008|O2|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
1133956|NCT00476008|O1|Outcome|Placebo|Placebo : Placebo BID for 12 months
1133957|NCT00476008|O2|Outcome|Memantine|Memantine: One tablet memantine (Namenda)10mg morning and evening (BID) for 12 months
1133958|NCT00476008|O1|Outcome|Placebo|Placebo: One tablet placebo morning and evening (BID) for 12 months
1133959|NCT00476008|O2|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
1133960|NCT00476008|O1|Outcome|Placebo|Placebo : Placebo BID for 12 months
1133961|NCT00476008|O2|Outcome|Placebo|Placebo : Placebo BID for 12 months
1133962|NCT00476008|O1|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
1133963|NCT00476008|E2|Reported Event|Placebo|Placebo : Placebo BID for 12 months
1133964|NCT00476008|E1|Reported Event|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
1133965|NCT00475904|B4|Baseline|Total|Total of all reporting groups
1134629|NCT00474630|O2|Outcome|Placebo|Placebo
1133968|NCT00475904|B1|Baseline|Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules|amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily
1133969|NCT00475904|P3|Participant Flow|Placebo Cream and Capsules|placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily
1133970|NCT00475904|P2|Participant Flow|Gabapentin Capsules, Placebo Cream|oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily
1133971|NCT00475904|P1|Participant Flow|Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules|amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily
1133972|NCT00475904|O3|Outcome|Placebo Cream and Capsules|placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily
1133973|NCT00475904|O2|Outcome|Gabapentin Capsules, Placebo Cream|oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily
1133974|NCT00475904|O1|Outcome|Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules|amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily
1133975|NCT00475904|O3|Outcome|Placebo Cream and Capsules|placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily
1133976|NCT00475904|O2|Outcome|Gabapentin Capsules, Placebo Cream|oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily
1133977|NCT00475904|O1|Outcome|Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules|amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily
1133978|NCT00475904|E3|Reported Event|Placebo Cream and Capsules|placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily
1133979|NCT00475904|E2|Reported Event|Gabapentin Capsules, Placebo Cream|oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily
1133980|NCT00475904|E1|Reported Event|Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules|amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily
1133981|NCT00475878|B3|Baseline|Total|Total of all reporting groups
1133982|NCT00475878|B2|Baseline|10 mg Escitalopram|10 mg escitalopram pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
1133983|NCT00475878|B1|Baseline|Placebo|placebo pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
1133984|NCT00475878|P2|Participant Flow|10 mg Escitalopram|10 mg escitalopram pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
1133985|NCT00475878|P1|Participant Flow|Placebo|placebo pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
1133986|NCT00475878|O2|Outcome|Placebo|individuals were given a placebo study medication prior to buprenorphine induction
1133987|NCT00475878|O1|Outcome|10 mg Escitalopram|individuals were given 10mg escitalopram prior to buprenorphine induction
1133988|NCT00475878|O2|Outcome|Placebo|in a double-blind, randomized controlled trial, participants were given placebo prior to buprenorphine induction
1133989|NCT00475878|O1|Outcome|10 mg Escitalopram|in a double-blind, randomized controlled trial, participants were given 10mg escitalopram prior to buprenorphine induction
1133990|NCT00475878|E2|Reported Event|10 mg Escitalopram|10 mg escitalopram pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
1133991|NCT00475878|E1|Reported Event|Placebo|placebo pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
1133992|NCT00475865|B4|Baseline|Total|Total of all reporting groups
1133993|NCT00475865|B3|Baseline|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
1133994|NCT00475865|B2|Baseline|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
1133995|NCT00475865|B1|Baseline|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
1133996|NCT00475865|P3|Participant Flow|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA] for 24 weeks
1133997|NCT00475865|P2|Participant Flow|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA] for 24 weeks
1133998|NCT00475865|P1|Participant Flow|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA] for 24 weeks
1133999|NCT00475865|O2|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
1134000|NCT00475865|O1|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
1134001|NCT00475865|O3|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
1134002|NCT00475865|O2|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
1134003|NCT00475865|O1|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
1134004|NCT00475865|O3|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
1134005|NCT00475865|O2|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
1134006|NCT00475865|O1|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
1134007|NCT00475865|O3|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
1134008|NCT00475865|O2|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
1134009|NCT00475865|O1|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
1134010|NCT00475865|O3|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
1134011|NCT00475865|O2|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
1134012|NCT00475865|O1|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
1134013|NCT00475865|O3|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
1134014|NCT00475865|O2|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
1134015|NCT00475865|O1|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
1134016|NCT00475865|O3|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
1134017|NCT00475865|O2|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
1134018|NCT00475865|O1|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
1134019|NCT00475865|O3|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
1134020|NCT00475865|O2|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
1134021|NCT00475865|O1|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
1134022|NCT00475865|E3|Reported Event|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
1134023|NCT00475865|E2|Reported Event|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
1134024|NCT00475865|E1|Reported Event|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
1134025|NCT00475852|B3|Baseline|Total|Total of all reporting groups
1134026|NCT00475852|B2|Baseline|Placebo|Matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
1134027|NCT00475852|B1|Baseline|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
1134028|NCT00475852|P2|Participant Flow|Placebo|Matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
1134029|NCT00475852|P1|Participant Flow|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
1134030|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
1134031|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
1134032|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
1134033|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
1134034|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
1134035|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
1134036|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
1134037|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
1134038|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
1134039|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
1134040|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
1134041|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
1134042|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
1134043|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
1134044|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
1134045|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
1134046|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
1134047|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
1134048|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
1134049|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
1135042|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
1134050|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
1134051|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
1134052|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
1134053|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
1134054|NCT00475852|E2|Reported Event|Placebo|Matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
1134055|NCT00475852|E1|Reported Event|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
1134056|NCT00475787|B3|Baseline|Total|Total of all reporting groups
1134057|NCT00475787|B2|Baseline|Arm 2|"Detuned Ultrasound~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
1134058|NCT00475787|B1|Baseline|Arm 1|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
1134059|NCT00475787|P2|Participant Flow|Arm 2|"Detuned Ultrasound~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
1134060|NCT00475787|P1|Participant Flow|Arm 1|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
1134061|NCT00475787|O2|Outcome|Sham Group|"Detuned Ultrasound~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
1134062|NCT00475787|O1|Outcome|Spinal Manipulative Therapy|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
1134063|NCT00475787|O2|Outcome|Arm 2|"Detuned Ultrasound~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
1134064|NCT00475787|O1|Outcome|Arm 1|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
1134065|NCT00475787|O2|Outcome|Arm 2|"Detuned Ultrasound~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
1134066|NCT00475787|O1|Outcome|Arm 1|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
1134067|NCT00475787|O2|Outcome|Arm 2|"Detuned Ultrasound~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
1134068|NCT00475787|O1|Outcome|Arm 1|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
1134069|NCT00475787|O2|Outcome|Sham Group|"Detuned Ultrasound~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
1134070|NCT00475787|O1|Outcome|Spinal Manipulative Therapy|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
1134071|NCT00475787|E2|Reported Event|Sham Intervention|Detuned Ultrasound
1134072|NCT00475787|E1|Reported Event|Spinal Manipulative Therapy|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
1134073|NCT00475735|B7|Baseline|Total|Total of all reporting groups
1134074|NCT00475735|B6|Baseline|Placebo Then Concerta|These participants received placebo during Treatment Period 1 and Concerta during Treatment Period 2
1134075|NCT00475735|B5|Baseline|Concerta Then Placebo|These participants received Concerta during Treatment Period 1 and placebo during Treatment Period 2
1134076|NCT00475735|B4|Baseline|Concerta Then MK-0249|These participants received Concerta during Treatment Period 1 and MK-0249 during Treatment Period 2
1134077|NCT00475735|B3|Baseline|MK-0249 Then Concerta|These participants received MK-0249 during Treatment Period 1 and Concerta during Treatment Period 2
1134078|NCT00475735|B2|Baseline|Placebo Then MK-0249|These participants received placebo during Treatment Period 1 and MK-0249 during Treatment Period 2
1134079|NCT00475735|B1|Baseline|MK-0249 Then Placebo|These participants received MK-0249 during Treatment Period 1 and placebo during Treatment Period 2
1134080|NCT00475735|P6|Participant Flow|Placebo Then Concerta|These participants received placebo during Treatment Period 1 and Concerta during Treatment Period 2
1134081|NCT00475735|P5|Participant Flow|Concerta Then Placebo|These participants received Concerta during Treatment Period 1 and placebo during Treatment Period 2
1134082|NCT00475735|P4|Participant Flow|Concerta Then MK-0249|These participants received Concerta during Treatment Period 1 and MK-0249 during Treatment Period 2
1134083|NCT00475735|P3|Participant Flow|MK-0249 Then Concerta|These participants received MK-0249 during Treatment Period 1 and Concerta during Treatment Period 2
1134084|NCT00475735|P2|Participant Flow|Placebo Then MK-0249|These participants received placebo during Treatment Period 1 and MK-0249 during Treatment Period 2
1134085|NCT00475735|P1|Participant Flow|MK-0249 Then Placebo|These participants received MK-0249 during Treatment Period 1 and placebo during Treatment Period 2
1134128|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
1134235|NCT00475319|O3|Outcome|Placebo|0% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
1134086|NCT00475735|O3|Outcome|Placebo|For 4 of the 6 treatment sequences, patients had one 4-week treatment period with placebo of MK-0249 (tablets) and placebo of Concerta (capsules). For patients assigned to active treatments of MK-0249 or Concerta, in order to preserve the blind, placebo of the non-active component was provided, ie, if MK was assigned (tablets), then placebo of Concerta (capsules) was also provided. Each patient was to dose with tablets and capsules, either active or placebo. Placebo was taken orally once daily.
1134087|NCT00475735|O2|Outcome|Concerta|Titration of Concerta began with two 18-mg capsules (36 mg) for 3 consecutive days, followed by three 18-mg capsules (54 mg) for another 3 consecutive days, ending with four 18-mg capsules (72 mg) for the remainder of the treatment period. If patients were unable to tolerate 72 mg per day, they were allowed to titrate down to 54 mg per day. Concerta was taken orally once daily.
1134088|NCT00475735|O1|Outcome|MK-0249|MK-0249, 10 mg per day was taken orally daily. If patients were unable to tolerate 10 mg per day, they were allowed to titrate down to 5 mg per day.
1134089|NCT00475735|O3|Outcome|Placebo|For 4 of the 6 treatment sequences, patients had one 4-week treatment period with placebo of MK-0249 (tablets) and placebo of Concerta (capsules). For patients assigned to active treatments of MK-0249 or Concerta, in order to preserve the blind, placebo of the non-active component was provided, ie, if MK was assigned (tablets), then placebo of Concerta (capsules) was also provided. Each patient was to dose with tablets and capsules, either active or placebo. Placebo was taken orally once daily.
1134090|NCT00475735|O2|Outcome|Concerta|Titration of Concerta began with two 18-mg capsules (36 mg) for 3 consecutive days, followed by three 18-mg capsules (54 mg) for another 3 consecutive days, ending with four 18-mg capsules (72 mg) for the remainder of the treatment period. If patients were unable to tolerate 72 mg per day, they were allowed to titrate down to 54 mg per day. Concerta was taken orally once daily.
1134091|NCT00475735|O1|Outcome|MK-0249|MK-0249, 10 mg per day was taken orally daily. If patients were unable to tolerate 10 mg per day, they were allowed to titrate down to 5 mg per day.
1134249|NCT00475306|P4|Participant Flow|Metoclopramide 10+Diphenhydramine|Metoclopramide 10 mg co-administered with diphenhydramine 25 mg, intravenously
1134092|NCT00475735|E3|Reported Event|Placebo|For 4 of the 6 treatment sequences, patients had one 4-week treatment period with placebo of MK-0249 (tablets) and placebo of Concerta (capsules). For patients assigned to active treatments of MK-0249 or Concerta, in order to preserve the blind, placebo of the non-active component was provided, ie, if MK was assigned (tablets), then placebo of Concerta (capsules) was also provided. Each patient was to dose with tablets and capsules, either active or placebo. Placebo was taken orally once daily.
1134093|NCT00475735|E2|Reported Event|Concerta|Titration of Concerta began with two 18-mg capsules (36 mg) for 3 consecutive days, followed by three 18-mg capsules (54 mg) for another 3 consecutive days, ending with four 18-mg capsules (72 mg) for the remainder of the treatment period. If patients were unable to tolerate 72 mg per day, they were allowed to titrate down to 54 mg per day. Concerta was taken orally once daily.
1134094|NCT00475735|E1|Reported Event|MK-0249|MK-0249, 10 mg per day was taken orally daily. If patients were unable to tolerate 10 mg per day, they were allowed to titrate down to 5 mg per day.
1134095|NCT00475722|B3|Baseline|Total|Total of all reporting groups
1134096|NCT00475722|B2|Baseline|2 Mediterranean|"Mediterranean Diet using an exchange list~2 Mediterranean: 6 months telephone counseling"
1134097|NCT00475722|B1|Baseline|1 Healthy Eating|"Healthy People 2010 Diet using an exchange list~1 Healthy Eating: 6 months telephone counseling"
1134098|NCT00475722|P2|Participant Flow|2 Mediterranean|"Mediterranean Diet~Mediterranean Diet through dietary counseling: 6 months telephone counseling"
1134099|NCT00475722|P1|Participant Flow|1 Healthy Eating|"Healthy People 2010 Diet~Healthy People 2010 Diet through dietary counseling: 6 months telephone counseling"
1134100|NCT00475722|O2|Outcome|2 Mediterranean|"Mediterranean Diet~Mediterranean Diet through dietary counseling: 6 months telephone counseling"
1134101|NCT00475722|O1|Outcome|1 Healthy Eating|"Healthy People 2010 Diet~Healthy People 2010 Diet through dietary counseling: 6 months telephone counseling"
1134102|NCT00475722|E2|Reported Event|2 Mediterranean|"Mediterranean Diet~Mediterranean Diet through dietary counseling: 6 months telephone counseling"
1134103|NCT00475722|E1|Reported Event|1 Healthy Eating|"Healthy People 2010 Diet~Healthy People 2010 Diet through dietary counseling: 6 months telephone counseling"
1134104|NCT00475709|B1|Baseline|Trifecta Aortic Heart Valve|All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
1134105|NCT00475709|P1|Participant Flow|Subjects Implanted With Trifecta Valve|All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
1134106|NCT00475709|O1|Outcome|Trifecta Aortic Heart Valve|All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
1134107|NCT00475709|O1|Outcome|Trifecta Aortic Heart Valve|All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
1134108|NCT00475709|O1|Outcome|Trifecta Aortic Heart Valve|All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
1134109|NCT00475709|E1|Reported Event|Subjects Implanted With Trifecta Valve|
1134110|NCT00475670|B3|Baseline|Total|Total of all reporting groups
1134111|NCT00475670|B2|Baseline|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
1134112|NCT00475670|B1|Baseline|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
1134154|NCT00475501|O4|Outcome|Arm 4|"placebo~Life Satisfaction A"
1134155|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Life Satisfaction A"
1134156|NCT00475501|O2|Outcome|Arm 2|"finasteride~Finasteride : 5 mg, oral, once/day, for 52 weeks~Life Satisfaction A"
1135288|NCT00473655|O3|Outcome|Placebo|Placebo
1134113|NCT00475670|P2|Participant Flow|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/square meter (m^2), IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
1134114|NCT00475670|P1|Participant Flow|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
1134115|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
1134116|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
1134117|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
1134118|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
1134250|NCT00475306|P3|Participant Flow|Metoclopramide 10 + Placebo|Metoclopramide 10 mg co-administered with placebo, intravenously
1134119|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
1134120|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
1134121|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
1134122|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
1134123|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
1134124|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
1134125|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
1134126|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
1134127|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
1134157|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Life Satisfaction A"
1134129|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
1134130|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
1134131|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
1134132|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
1134133|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
1134134|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
1140884|NCT00460239|O3|Outcome|Morphine 30 mg|
1134135|NCT00475670|E2|Reported Event|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
1134136|NCT00475670|E1|Reported Event|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
1134137|NCT00475657|B1|Baseline|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
1134138|NCT00475657|P1|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
1134139|NCT00475657|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
1134140|NCT00475657|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
1134141|NCT00475657|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
1134142|NCT00475657|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
1134143|NCT00475657|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
1134144|NCT00475657|E1|Reported Event|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
1134145|NCT00475501|B5|Baseline|Total|Total of all reporting groups
1134146|NCT00475501|B4|Baseline|Vehicle Placebo|weekly vehicle injection daily placebo pill
1134147|NCT00475501|B3|Baseline|Testosterone Finasteride|125 mg testosterone enanthate/week i.m. 5 mg finasteride/day p.o.
1134148|NCT00475501|B2|Baseline|Vehicle Finasteride|weekly vehicle injection 5 mg finasteride/day p.o.
1134149|NCT00475501|B1|Baseline|Testosterone Vehicle|125 mg testosterone enanthate/week i.m. daily placebo pill
1134150|NCT00475501|P4|Participant Flow|Arm 4|"placebo~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
1134151|NCT00475501|P3|Participant Flow|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
1134152|NCT00475501|P2|Participant Flow|Arm 2|"finasteride~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed.~Finasteride : 5 mg, oral, once/day, for 52 weeks"
1134153|NCT00475501|P1|Participant Flow|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
1134158|NCT00475501|O4|Outcome|Arm 4|"placebo~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
1134159|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
1134160|NCT00475501|O2|Outcome|Arm 2|"finasteride~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed.~Finasteride : 5 mg, oral, once/day, for 52 weeks"
1134161|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
1134162|NCT00475501|O4|Outcome|Arm 4|"placebo~Daily dietary protein intake (gm/kg body weight) derived from 3-day food log"
1134163|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Daily dietary protein intake (gm/kg body weight) derived from 3-day food log"
1134164|NCT00475501|O2|Outcome|Arm 2|"finasteride~Finasteride : 5 mg, oral, once/day, for 52 weeks~Daily dietary protein intake (gm/kg body weight) derived from 3-day food log"
1134251|NCT00475306|P2|Participant Flow|Metoclopramide 20+Placebo|Metoclopramide 20 mg co-administered with placebo, intravenously
1134165|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Daily dietary protein intake (gm/kg body weight) derived from 3-day food log"
1134166|NCT00475501|O4|Outcome|Arm 4|"placebo~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
1134167|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
1134168|NCT00475501|O2|Outcome|Arm 2|"finasteride~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed.~Finasteride : 5 mg, oral, once/day, for 52 weeks"
1134169|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
1134170|NCT00475501|O4|Outcome|Arm 4|"placebo~Benton Test -Judgment of Line Orientation"
1134171|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Benton Test -Judgment of Line Orientation"
1134172|NCT00475501|O2|Outcome|Arm 2|"finasteride~Benton Test -Judgment of Line Orientation~Finasteride : 5 mg, oral, once/day, for 52 weeks"
1134173|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Benton Test -Judgment of Line Orientation"
1134174|NCT00475501|O4|Outcome|Arm 4|"placebo~Trail Making Test A"
1134175|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Trail Making Test A"
1134176|NCT00475501|O2|Outcome|Arm 2|"finasteride~Trail Making Test A Finasteride : 5 mg, oral, once/day, for 52 weeks"
1134177|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Trail Making Test A"
1134178|NCT00475501|O4|Outcome|Arm 4|"placebo~30 minute recall portion of Rey Osterrieth Complex Figure (ROCF) test"
1134179|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~30 minute recall portion of Rey Osterrieth Complex Figure (ROCF) test"
1134180|NCT00475501|O2|Outcome|Arm 2|"finasteride~30 minute recall portion of Rey Osterrieth Complex Figure (ROCF) test Finasteride : 5 mg, oral, once/day, for 52 weeks"
1134181|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~30 minute recall portion of Rey Osterrieth Complex Figure (ROCF) test"
1134182|NCT00475501|O4|Outcome|Vehicle Placebo|Geriatric Depression Scale (GDS): This 15-item, yes/no questionnaire will be administered at baseline, after 3, 6, 9 and 12 months of treatment and at follow-up.
1134183|NCT00475501|O3|Outcome|Testosterone Finasteride|Geriatric Depression Scale (GDS): This 15-item, yes/no questionnaire will be administered at baseline, after 3, 6, 9 and 12 months of treatment and at follow-up.
1134184|NCT00475501|O2|Outcome|Vehicle Finasteride|Geriatric Depression Scale (GDS): This 15-item, yes/no questionnaire will be administered at baseline, after 3, 6, 9 and 12 months of treatment and at follow-up.
1134185|NCT00475501|O1|Outcome|Testosterone Vehicle|Geriatric Depression Scale (GDS): This 15-item, yes/no questionnaire will be administered at baseline, after 3, 6, 9 and 12 months of treatment and at follow-up.
1134186|NCT00475501|O4|Outcome|Arm 4|"placebo~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
1134234|NCT00475319|P1|Participant Flow|1% OPC-12759 Groups|1% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
1135289|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
1134187|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
1134188|NCT00475501|O2|Outcome|Arm 2|"finasteride~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed.~Finasteride : 5 mg, oral, once/day, for 52 weeks"
1134189|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
1134190|NCT00475501|O4|Outcome|Vehicle Placebo|grip strength measure on a dynamometer
1134191|NCT00475501|O3|Outcome|Testosterone Finasteride|grip strength measure on a dynamometer
1134192|NCT00475501|O2|Outcome|Vehicle Finasteride|grip strength measure on a dynamometer
1134193|NCT00475501|O1|Outcome|Testosterone Vehicle|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~grip strength measure on a dynamometer"
1134194|NCT00475501|O4|Outcome|Arm 4|"placebo~Measurement of leg press strength, 1-RM"
1134195|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Measurement of leg press strength, 1-RM"
1134196|NCT00475501|O2|Outcome|Arm 2|"finasteride~Measurement of leg press strength, 1-RM Finasteride : 5 mg, oral, once/day, for 52 weeks"
1134197|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Measurement of leg press strength, 1-RM"
1134198|NCT00475501|E4|Reported Event|Arm 4|placebo
1134199|NCT00475501|E3|Reported Event|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks"
1134200|NCT00475501|E2|Reported Event|Arm 2|"finasteride~Finasteride : 5 mg, oral, once/day, for 52 weeks"
1134201|NCT00475501|E1|Reported Event|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks"
1134202|NCT00475423|B1|Baseline|Rituximab|Participants received rituximab 1000 mg IV on Days 1 and 15.
1134203|NCT00475423|P1|Participant Flow|Rituximab|Participants received rituximab 1000 milligrams (mg) intravenously (IV) on Days 1 and 15.
1134204|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
1134205|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
1134206|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
1134207|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
1134208|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
1134209|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
1134210|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
1134211|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
1134212|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
1134213|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
1134214|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
1134215|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
1134216|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
1134217|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
1134218|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
1134219|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
1134220|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
1134221|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
1134222|NCT00475423|E1|Reported Event|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
1134223|NCT00475332|B1|Baseline|Radiotherapy Followed by Bexxar|All patients enrolled received the same treatment: 20 Gray of radiation in 10 treatments followed by Bexxar.
1134224|NCT00475332|P1|Participant Flow|Radiotherapy Followed by Bexxar|All patients enrolled received the same treatment: 20 Gray of radiation in 10 treatments followed by Bexxar.
1134225|NCT00475332|O1|Outcome|Radiotherapy Followed by Bexxar|All patients enrolled received the same treatment: 20 Gray of radiation in 10 treatments followed by Bexxar.
1134226|NCT00475332|O1|Outcome|Radiation Followed by Bexxar|All patients enrolled received the same treatment: 20 Gray of radiation in 10 treatments followed by Bexxar.
1134227|NCT00475332|E1|Reported Event|Radiotherapy Followed by Bexxar|All patients enrolled received the same treatment: 20 Gray of radiation in 10 treatments followed by Bexxar.
1134228|NCT00475319|B4|Baseline|Total|Total of all reporting groups
1134229|NCT00475319|B3|Baseline|Placebo|0% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
1134230|NCT00475319|B2|Baseline|2% OPC-12759 Groups|2% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
1134231|NCT00475319|B1|Baseline|1% OPC-12759 Groups|1% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
1134232|NCT00475319|P3|Participant Flow|Placebo|0% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
1134233|NCT00475319|P2|Participant Flow|2% OPC-12759 Groups|2% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
1134236|NCT00475319|O2|Outcome|2% OPC-12759 Groups|2% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
1134237|NCT00475319|O1|Outcome|1% OPC-12759 Groups|1% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
1134238|NCT00475319|O3|Outcome|Placebo|0% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.
1134239|NCT00475319|O2|Outcome|2% OPC-12759 Ophthalmic Suspension|2% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.
1134240|NCT00475319|O1|Outcome|1% OPC-12759 Ophthalmic Suspension|1% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.
1134241|NCT00475319|E3|Reported Event|Placebo|0% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
1134242|NCT00475319|E2|Reported Event|2% OPC-12759 Groups|2% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
1134243|NCT00475319|E1|Reported Event|1% OPC-12759 Groups|1% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
1134244|NCT00475306|B5|Baseline|Total|Total of all reporting groups
1134245|NCT00475306|B4|Baseline|Metoclopramide 10+Diphenhydramine|Metoclopramide 10mg co-administered with diphenhydramine 25mg, intravenously
1134246|NCT00475306|B3|Baseline|Metoclopramide 10 + Placebo|Metoclopramide 10 mg co-administered with placebo, intravenously
1134247|NCT00475306|B2|Baseline|Metoclopramide 20+Placebo|Metoclopramide 20 mg co-administered with placebo, intravenously
1134248|NCT00475306|B1|Baseline|Metoclopramide 20mg+Diphenhydramine|Metoclopramide 20 mg co-administered with diphenhydramine 25mg, intravenously
1134630|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
1134252|NCT00475306|P1|Participant Flow|Metoclopramide 20 mg+Diphenhydramine|Metoclopramide 20mg co-administered with diphenhydramine 25 mg, intravenously
1134253|NCT00475306|O4|Outcome|Metoclopramide 10+Diphenhydramine|Metoclopramide 10mg co-administered with diphenhydramine 25mg, intravenously
1134254|NCT00475306|O3|Outcome|Metoclopramide 10 + Placebo|Metoclopramide 10 mg co-administered with placebo, intravenously
1134255|NCT00475306|O2|Outcome|Metoclopramide 20+Placebo|Metoclopramide 20 mg co-administered with placebo, intravenously
1134256|NCT00475306|O1|Outcome|Metoclopramide 20mg+Diphenhydramine|Metoclopramide 20 mg co-administered with diphenhydramine 25mg, intravenously
1134257|NCT00475306|O4|Outcome|Metoclopramide 10+Diphenhydramine|Metoclopramide 10mg co-administered with diphenhydramine 25mg, intravenously
1134258|NCT00475306|O3|Outcome|Metoclopramide 10 + Placebo|Metoclopramide 10 mg co-administered with placebo, intravenously
1134259|NCT00475306|O2|Outcome|Metoclopramide 20+Placebo|Metoclopramide 20 mg co-administered with placebo, intravenously
1134260|NCT00475306|O1|Outcome|Metoclopramide 20mg+Diphenhydramine|Metoclopramide 20 mg co-administered with diphenhydramine 25mg, intravenously
1134261|NCT00475306|E4|Reported Event|Metoclopramide 10+Diphenhydramine|Metoclopramide 10mg co-administered with diphenhydramine 25mg, intravenously
1134262|NCT00475306|E3|Reported Event|Metoclopramide 10 + Placebo|Metoclopramide 10 mg co-administered with placebo, intravenously
1134263|NCT00475306|E2|Reported Event|Metoclopramide 20+Placebo|Metoclopramide 20 mg co-administered with placebo, intravenously
1134264|NCT00475306|E1|Reported Event|Metoclopramide 20mg+Diphenhydramine|Metoclopramide 20 mg co-administered with diphenhydramine 25mg, intravenously
1134265|NCT00475241|B3|Baseline|Total|Total of all reporting groups
1134266|NCT00475241|B2|Baseline|Present Centered Therapy|"Present centered therapy for PTSD~Present centered therapy for PTSD: present focused coping and problem solving for PTSD"
1134267|NCT00475241|B1|Baseline|Prolonged Exposure|"Prolonged exposure therapy for PTSD~Prolonged Exposure therapy for PTSD: exposure-based treatment for PTSD"
1134268|NCT00475241|P2|Participant Flow|Present Centered Therapy|"Present centered therapy for PTSD~Present centered therapy for PTSD: present focused coping and problem solving for PTSD"
1134269|NCT00475241|P1|Participant Flow|Prolonged Exposure|"Prolonged exposure therapy for PTSD~Prolonged Exposure therapy for PTSD: exposure-based treatment for PTSD"
1134270|NCT00475241|O2|Outcome|Present Centered Therapy|"Present centered therapy for PTSD~Present centered therapy for PTSD: present focused coping and problem solving for PTSD"
1134271|NCT00475241|O1|Outcome|Prolonged Exposure|"Prolonged exposure therapy for PTSD~Prolonged Exposure therapy for PTSD: exposure-based treatment for PTSD"
1134272|NCT00475241|E2|Reported Event|Present Centered Therapy|"Present centered therapy for PTSD~Present centered therapy for PTSD: present focused coping and problem solving for PTSD"
1134273|NCT00475241|E1|Reported Event|Prolonged Exposure|"Prolonged exposure therapy for PTSD~Prolonged Exposure therapy for PTSD: exposure-based treatment for PTSD"
1134274|NCT00475228|B3|Baseline|Total|Total of all reporting groups
1134275|NCT00475228|B2|Baseline|Arm 2: Delayed LNG-IUD Insertion Group|Subjects randomized to Arm 2 had the Levonorgestrel IUD placed at 3 to 6 weeks post-procedure as per standard of care practice.
1134276|NCT00475228|B1|Baseline|Arm I: Immediate LNG-IUD Insertion Group|Subjects randomized to Arm I had the Levonorgestrel IUD placed using ultrasound guidance immediately after completion of D& E
1134277|NCT00475228|P2|Participant Flow|Arm 2: Delayed (3-6 Weeks) LNG-IUD Insertion Group|"Levonorgestrel IUD will be inserted at standard time post-procedure (3-6 weeks post D&E procedure)~Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem"
1134278|NCT00475228|P1|Participant Flow|Arm I: Immediate LNG-IUD Insertion Group|"Levonorgestrel IUD will be inserted immediately after completion of D&E~Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem"
1134279|NCT00475228|O2|Outcome|Arm 2: Delayed LNG-IUD Insertion Group|Subjects randomized to Arm 2 had the Levonorgestrel IUD placed at 3 to 6 weeks post-procedure as per standard of care practice.
1134280|NCT00475228|O1|Outcome|Arm I: Immediate LNG-IUD Insertion Group|Subjects randomized to Arm I had the Levonorgestrel IUD placed using ultrasound guidance immediately after completion of D& E
1134281|NCT00475228|O2|Outcome|Arm I: Immediate LNG-IUD Insertion Group|"Levonorgestrel IUD was inserted immediately after completion of D&E in all 44 participants~Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem"
1134282|NCT00475228|O1|Outcome|Arm 2: Delayed (3-6 Weeks) LNG-IUD Insertion Group|"Levonorgestrel IUD was inserted at standard time post-procedure (3-6 weeks post D&E procedure) in 20 participants. The remaining 24 women did not return 3-6 weeks after the D&E.~Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem"
1134283|NCT00475228|O2|Outcome|Arm 2: Delayed (3-6 Weeks) LNG-IUD Insertion Group|"Levonorgestrel IUD will be inserted at standard time post-procedure (3-6 weeks post D&E procedure)~Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem"
1134284|NCT00475228|O1|Outcome|Arm I: Immediate LNG-IUD Insertion Group|"Levonorgestrel IUD will be inserted immediately after completion of D&E~Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem"
1134285|NCT00475228|E2|Reported Event|Arm 2|"Levonorgestrel IUD will be inserted at standard time post-procedure (3-6 weeks post D&E procedure)~Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem"
1134286|NCT00475228|E1|Reported Event|Arm I|"Levonorgestrel IUD will be inserted immediately after completion of D&E~Levonorgestrel IUD: intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem"
1134287|NCT00475176|B1|Baseline|Hepatitis C Treated With Peginterferon and Ribavirin|Patients infected with hepatitis C virus (HCV) treated with peginterferon alpha-2a and ribavirin
1134314|NCT00475085|P3|Participant Flow|Arm 3 Aprepitant, Palonosetron, Dexamethasone|"Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.~placebo : Given orally~aprepitant : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
1134288|NCT00475176|P1|Participant Flow|Hepatitis C Treated With Peginterferon and Ribavirin|Patients infected with hepatitis C virus (HCV) treated with peginterferon alpha-2a and ribavirin. After screening evaluation, patients will receive a first course of 2 weeks of peginterferon alfa-2a (180 micrograms weekly) and ribavirin (1000-1200 mg daily) during which symptoms, routine laboratory tests, HCV RNA levels, natural killer (NK) cell activity, and lymphocyte interferon-signaling responses will be monitored. After a 4-week washout period, patients will start SAMe (800 mg twice daily) for 2 weeks and then begin a second course of peginterferon and ribavirin in the same doses with similar monitoring. Therapy will be continued for at least 12 weeks, and patients with an early viral response will continue for a full 48 weeks.
1134289|NCT00475176|O1|Outcome|Hepatitis C Treated With Peginterferon and Ribavirin|Patients infected with hepatitis C virus (HCV) treated with peginterferon alpha-2a and ribavirin
1134290|NCT00475176|O1|Outcome|Hepatitis C Treated With Peginterferon and Ribavirin|Patients infected with hepatitis C virus (HCV) treated with peginterferon alpha-2a and ribavirin
1134291|NCT00475176|E1|Reported Event|Hepatitis C Treated With Peginterferon and Ribavirin|Patients infected with hepatitis C virus (HCV) treated with peginterferon alpha-2a and ribavirin
1134292|NCT00475150|B3|Baseline|Total|Total of all reporting groups
1134293|NCT00475150|B2|Baseline|Myelodysplastic Syndrome (MDS)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
1134294|NCT00475150|B1|Baseline|Acute Myeloid Leukemia (AML)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
1134295|NCT00475150|P2|Participant Flow|Myelodysplastic Syndrome (MDS)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
1134296|NCT00475150|P1|Participant Flow|Acute Myeloid Leukemia (AML)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
1134297|NCT00475150|O2|Outcome|Myelodysplastic Syndrome (MDS)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
1134298|NCT00475150|O1|Outcome|Acute Myeloid Leukemia (AML)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
1134299|NCT00475150|O2|Outcome|Myelodysplastic Syndrome (MDS)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
1134300|NCT00475150|O1|Outcome|Acute Myeloid Leukemia (AML)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
1134301|NCT00475150|O2|Outcome|Myelodysplastic Syndrome (MDS)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
1134302|NCT00475150|O1|Outcome|Acute Myeloid Leukemia (AML)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
1134303|NCT00475150|O2|Outcome|Myelodysplastic Syndrome (MDS)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
1134304|NCT00475150|O1|Outcome|Acute Myeloid Leukemia (AML)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
1134305|NCT00475150|O2|Outcome|Myelodysplastic Syndrome (MDS)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
1134306|NCT00475150|O1|Outcome|Acute Myeloid Leukemia (AML)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
1134307|NCT00475150|E1|Reported Event|All Patients Receiving Cediranib Maleate|All patients receiving oral cediranib maleate, regardless of diagnosis were analyzed for toxicity.
1134308|NCT00475085|B5|Baseline|Total|Total of all reporting groups
1135290|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
1134309|NCT00475085|B4|Baseline|Arm IV|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
1134310|NCT00475085|B3|Baseline|Arm I|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
1134311|NCT00475085|B2|Baseline|Arm III|"Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.~placebo : Given orally~aprepitant : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
1134312|NCT00475085|B1|Baseline|Arm II|"Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~granisetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
1134313|NCT00475085|P4|Participant Flow|Arm 4 Palonosetron, Dexamethasone, Compazine, Dexamethasone|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
1134404|NCT00474929|B6|Baseline|Total|Total of all reporting groups
1134405|NCT00474929|B5|Baseline|Phase II|Phase II: Sorafenib 200 mg twice daily, RAD001 5mg every day;
1134631|NCT00474630|O2|Outcome|Placebo|Placebo
1134315|NCT00475085|P2|Participant Flow|Arm 2 Granisetron, Dexamethasone, Compazine|"Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~granisetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
1134316|NCT00475085|P1|Participant Flow|Arm 1 Palonosetron, Dexamethasone, Compazine|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
1134317|NCT00475085|O4|Outcome|Arm IV|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
1134318|NCT00475085|O3|Outcome|Arm I|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
1134319|NCT00475085|O2|Outcome|Arm III|"Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.~placebo : Given orally~aprepitant : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
1134320|NCT00475085|O1|Outcome|Arm II|"Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~granisetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
1134321|NCT00475085|E4|Reported Event|Arm IV|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
1134322|NCT00475085|E3|Reported Event|Arm I|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
1134323|NCT00475085|E2|Reported Event|Arm III|"Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.~placebo : Given orally~aprepitant : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
1134324|NCT00475085|E1|Reported Event|Arm II|"Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~granisetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
1134325|NCT00475033|B3|Baseline|Total|Total of all reporting groups
1134326|NCT00475033|B2|Baseline|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134366|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134327|NCT00475033|B1|Baseline|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134328|NCT00475033|P2|Participant Flow|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134329|NCT00475033|P1|Participant Flow|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134330|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134331|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134332|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134333|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134334|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134335|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134336|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134490|NCT00474760|B1|Baseline|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134337|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134338|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134339|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134340|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134406|NCT00474929|B4|Baseline|Phase I, Dose Level 3|Phase I: Dose level 3: Sorafenib 400 mg twice daily, RAD001 10mg every day
1134407|NCT00474929|B3|Baseline|Phase I, Dose Level 2|Phase I: Dose level 2: Sorafenib 400 mg twice daily, RAD001 5mg every day
1134341|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134342|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134343|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134344|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134345|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134346|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134347|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134348|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134349|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134350|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134408|NCT00474929|B2|Baseline|Phase I, Dose Level 1|Phase I: Dose level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day
1134409|NCT00474929|B1|Baseline|Phase I, Dose Level 0|Phase I: Dose level 0: Sorafenib 200 mg twice daily, RAD001 5mg every other day;
1134351|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134352|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134353|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134354|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). Co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134355|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). Co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134395|NCT00474955|O1|Outcome|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
1134491|NCT00474760|P7|Participant Flow|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D Ewing’s sarcoma family of tumors [ESFT] extension cohort.
1134356|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). Co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134357|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). Co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134358|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134359|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134360|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134410|NCT00474929|P5|Participant Flow|Phase II|Phase II: Sorafenib 200 mg twice daily, RAD001 5mg every day;
1134411|NCT00474929|P4|Participant Flow|Phase I, Dose Level 3|Phase I: Dose level 3: Sorafenib 400 mg twice daily, RAD001 10mg every day
1134361|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134362|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134363|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134364|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134365|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134367|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134368|NCT00475033|E8|Reported Event|7vPnC Toddler Dose 6-Month Follow-up|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age (toddler dose), co-administered with NeisVac-C® at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134369|NCT00475033|E7|Reported Event|13vPnC Toddler Dose 6-Month Follow-up|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12 months of age (toddler dose), co-administered NeisVac-C® at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
1134370|NCT00475033|E6|Reported Event|7vPnC Toddler Dose|"Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age (toddler dose), co-administered with NeisVac-C® at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.~Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=108; systematic (solicited) Any Local Reactions N=86; systematic (solicited) Any Systemic Events N=193."
1134371|NCT00475033|E5|Reported Event|13vPnC Toddler Dose|"Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12 months of age (toddler dose), co-administered NeisVac-C® at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.~Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=110; systematic (solicited) Any Local Reactions N=84; systematic (solicited) Any Systemic Events N=199."
1134372|NCT00475033|E4|Reported Event|7vPnC After the Infant Series|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series), co-administered with Pentacel at 2, 4, and 6 months of age; NeisVac-C® at 2 and 6 months of age (infant series).
1134612|NCT00474630|B3|Baseline|Total|Total of all reporting groups
1134373|NCT00475033|E3|Reported Event|13vPnC After the Infant Series|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series), co-administered with Pentacel® at 2, 4, and 6 months of age; NeisVac-C® at 2 and 6 months of age (infant series).
1134374|NCT00475033|E2|Reported Event|7vPnC Infant Series|"Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series), co-administered with Pentacel at 2, 4, and 6 months of age; NeisVac-C® at 2 and 6 months of age (infant series).~Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=230; systematic (solicited) Any Local Reactions N=148; systematic (solicited) Any Systemic Events N=279."
1134375|NCT00475033|E1|Reported Event|13vPnC Infant Series|"Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series), co-administered with Pentacel® at 2, 4, and 6 months of age; NeisVac-C® at 2 and 6 months of age (infant series).~Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=229; systematic (solicited) Any Local Reactions N=144; systematic (solicited) Any Systemic Events N=273."
1134376|NCT00474994|B1|Baseline|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
1134377|NCT00474994|P1|Participant Flow|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
1134378|NCT00474994|O1|Outcome|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
1134379|NCT00474994|E1|Reported Event|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
1134380|NCT00474968|B3|Baseline|Total|Total of all reporting groups
1134381|NCT00474968|B2|Baseline|Brush/Spatula|Samples collected using an endocervical brush and cervical spatula
1134382|NCT00474968|B1|Baseline|SoftPAP|Samples collected using the SoftPAP Collector
1134383|NCT00474968|P2|Participant Flow|Brush/Spatula|Samples collected using an endocervical brush and cervical spatula
1134384|NCT00474968|P1|Participant Flow|SoftPAP|Samples collected using the SoftPAP Collector
1134385|NCT00474968|O2|Outcome|Brush/Spatula|Samples collected using an endocervical brush and cervical spatula
1134386|NCT00474968|O1|Outcome|SoftPAP|Samples collected using the SoftPAP Collector
1134387|NCT00474968|O2|Outcome|Brush/Spatula|Samples collected using an endocervical brush and cervical spatula
1134388|NCT00474968|O1|Outcome|SoftPAP|Samples collected using the SoftPAP Collector
1134389|NCT00474968|O2|Outcome|Brush/Spatula|Samples collected using an endocervical brush and cervical spatula
1134390|NCT00474968|O1|Outcome|SoftPAP|Samples collected using the SoftPAP Collector
1134391|NCT00474968|E2|Reported Event|Brush/Spatula|Samples collected using an endocervical brush and cervical spatula
1134392|NCT00474968|E1|Reported Event|SoftPAP|Samples collected using the SoftPAP Collector
1134393|NCT00474955|B1|Baseline|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
1134394|NCT00474955|P1|Participant Flow|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a [Pegasys] [40 kilo Dalton (kDa)], 180 micrograms (mcg) as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated glomerular filtration rate (GFR) of <15 milliliter (mL)/minute (min) were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
1134396|NCT00474955|O1|Outcome|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
1134397|NCT00474955|O1|Outcome|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
1134398|NCT00474955|O1|Outcome|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
1134399|NCT00474955|O1|Outcome|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
1134400|NCT00474955|O1|Outcome|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
1134401|NCT00474955|O1|Outcome|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
1134402|NCT00474955|O1|Outcome|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
1134403|NCT00474955|E1|Reported Event|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
1134412|NCT00474929|P3|Participant Flow|Phase I, Dose Level 2|Phase I: Dose level 2: Sorafenib 400 mg twice daily, RAD001 5mg every day
1134413|NCT00474929|P2|Participant Flow|Phase I, Dose Level 1|Phase I: Dose level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day
1134414|NCT00474929|P1|Participant Flow|Phase I, Dose Level 0|Phase I: Dose level 0: Sorafenib 200 mg twice daily, RAD001 5mg every other day
1134415|NCT00474929|O1|Outcome|Sorafenib 200 mg Twice Daily, RAD001 5mg Every Day|This endpoint was analyzed using all patients treated at the MTD (Dose Level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day). This includes the eligible Phase I participants treated at Dose Level 1 (N=5) and it includes all participants treated in Phase II (N=77).
1134416|NCT00474929|O1|Outcome|Sorafenib 200 mg Twice Daily, RAD001 5mg Every Day|This endpoint was analyzed using all patients treated at the MTD (Dose Level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day). This includes the eligible Phase I participants treated at Dose Level 1 (N=5) and it includes all participants treated in Phase II (N=77).
1134417|NCT00474929|O1|Outcome|Sorafenib 200 mg Twice Daily, RAD001 5mg Every Day|"This endpoint was analyzed using all patients treated at the MTD (Dose Level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day). Due to concerns about adverse events and frequent dose reductions seen on later cycles at dose level 2, the PI felt it was in the best interest of the patients to choose dose level 1 as the MTD and the dose level for Phase II.~Therefore, the analysis of the Phase II endpoint includes the eligible Phase I participants treated at Dose Level 1 (N=5) and it includes all participants treated in Phase II (N=77)."
1134418|NCT00474929|O4|Outcome|Phase I, Dose Level 3|Dose level 3: Sorafenib 400 mg twice daily, RAD001 10mg every day
1134419|NCT00474929|O3|Outcome|Phase I, Dose Level 2|Dose level 2: Sorafenib 400 mg twice daily, RAD001 5mg every day
1134420|NCT00474929|O2|Outcome|Phase I, Dose Level 1|Dose level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day
1134421|NCT00474929|O1|Outcome|Phase I, Dose Level 0|Phase I: Dose level 0: Sorafenib 200 mg twice daily, RAD001 5mg every other day
1134422|NCT00474929|E5|Reported Event|Phase II|Phase II: Sorafenib 200 mg twice daily, RAD001 5mg every day;
1134423|NCT00474929|E4|Reported Event|Phase I, Dose Level 3|Phase I: Dose level 3: Sorafenib 400 mg twice daily, RAD001 10mg every day
1134424|NCT00474929|E3|Reported Event|Phase I, Dose Level 2|Phase I: Dose level 2: Sorafenib 400 mg twice daily, RAD001 5mg every day
1134425|NCT00474929|E2|Reported Event|Phase I, Dose Level 1|Phase I: Dose level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day
1134426|NCT00474929|E1|Reported Event|Phase I, Dose Level 0|Phase I: Dose level 0: Sorafenib 200 mg twice daily, RAD001 5mg every other day
1134427|NCT00474903|B4|Baseline|Total|Total of all reporting groups
1134428|NCT00474903|B3|Baseline|Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
1134429|NCT00474903|B2|Baseline|Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
1134430|NCT00474903|B1|Baseline|Arm I (Placebo, Esomeprazole Magnesium)|"Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).~esomeprazole magnesium: Given orally placebo: Given orally"
1134431|NCT00474903|P3|Participant Flow|Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
1134489|NCT00474760|B2|Baseline|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134432|NCT00474903|P2|Participant Flow|Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
1134433|NCT00474903|P1|Participant Flow|Arm I (Placebo, Esomeprazole Magnesium)|"Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).~esomeprazole magnesium: Given orally placebo: Given orally"
1134434|NCT00474903|O3|Outcome|Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
1134435|NCT00474903|O2|Outcome|Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
1134436|NCT00474903|O1|Outcome|Arm I (Placebo, Esomeprazole Magnesium)|"Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).~esomeprazole magnesium: Given orally placebo: Given orally"
1134437|NCT00474903|O3|Outcome|Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
1134438|NCT00474903|O2|Outcome|Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
1134439|NCT00474903|O1|Outcome|Arm I (Placebo, Esomeprazole Magnesium)|"Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).~esomeprazole magnesium: Given orally placebo: Given orally"
1134440|NCT00474903|E3|Reported Event|Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
1134441|NCT00474903|E2|Reported Event|Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
1134442|NCT00474903|E1|Reported Event|Arm I (Placebo, Esomeprazole Magnesium)|"Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).~esomeprazole magnesium: Given orally placebo: Given orally"
1134443|NCT00474851|B3|Baseline|Total|Total of all reporting groups
1134444|NCT00474851|B2|Baseline|Placebo Group|"Placebo: Placebo capsule 1 pill PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
1134445|NCT00474851|B1|Baseline|Intervention Group|"Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
1134446|NCT00474851|P2|Participant Flow|Placebo Group|"Placebo group~Placebo: Placebo capsule 1 pill PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
1134447|NCT00474851|P1|Participant Flow|Intervention Group|"Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
1134448|NCT00474851|O2|Outcome|Placebo Group|"Placebo: Placebo capsule 1 pill PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
1134449|NCT00474851|O1|Outcome|Intervention Group|"Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
1134450|NCT00474851|O2|Outcome|Placebo Group|"Placebo group~Placebo: Placebo capsule 1 pill PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
1134451|NCT00474851|O1|Outcome|Intervention Group|"Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
1134452|NCT00474851|E2|Reported Event|Placebo Group|"Placebo group~Placebo: Placebo capsule 1 pill PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
1134453|NCT00474851|E1|Reported Event|Intervention Group|"Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
1134454|NCT00474812|B1|Baseline|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
1134455|NCT00474812|P1|Participant Flow|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
1134456|NCT00474812|O1|Outcome|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
1134457|NCT00474812|O1|Outcome|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
1134458|NCT00474812|O1|Outcome|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
1134459|NCT00474812|O1|Outcome|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
1134460|NCT00474812|O1|Outcome|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
1134461|NCT00474812|E1|Reported Event|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
1134462|NCT00474786|B3|Baseline|Total|Total of all reporting groups
1134463|NCT00474786|B2|Baseline|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
1134464|NCT00474786|B1|Baseline|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
1134465|NCT00474786|P2|Participant Flow|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
1134694|NCT00474539|O8|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
1134466|NCT00474786|P1|Participant Flow|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
1134467|NCT00474786|O2|Outcome|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
1134468|NCT00474786|O1|Outcome|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
1134469|NCT00474786|O2|Outcome|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
1134470|NCT00474786|O1|Outcome|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
1134471|NCT00474786|O2|Outcome|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
1134472|NCT00474786|O1|Outcome|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
1134473|NCT00474786|O2|Outcome|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
1134474|NCT00474786|O1|Outcome|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
1134613|NCT00474630|B2|Baseline|Placebo|Placebo
1140885|NCT00460239|O2|Outcome|Morphine 15 mg|
1134475|NCT00474786|O2|Outcome|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
1134476|NCT00474786|O1|Outcome|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
1134477|NCT00474786|O2|Outcome|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
1134478|NCT00474786|O1|Outcome|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
1134479|NCT00474786|O2|Outcome|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
1134480|NCT00474786|O1|Outcome|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
1134481|NCT00474786|E2|Reported Event|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
1134482|NCT00474786|E1|Reported Event|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
1134483|NCT00474760|B8|Baseline|Total|Total of all reporting groups
1134484|NCT00474760|B7|Baseline|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
1134485|NCT00474760|B6|Baseline|Figitumumab 20 mg/kg RP2D ACC+Sarcoma|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D ACC and sarcoma extension cohort.
1134486|NCT00474760|B5|Baseline|Figitumumab 20 mg/kg RP2D|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D extension cohort.
1134487|NCT00474760|B4|Baseline|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134488|NCT00474760|B3|Baseline|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1135291|NCT00473655|O3|Outcome|Placebo|Placebo
1134492|NCT00474760|P6|Participant Flow|Figitumumab 20 mg/kg RP2D ACC+Sarcoma|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D adrenocortical carcinoma [ACC] and sarcoma extension cohort.
1134493|NCT00474760|P5|Participant Flow|Figitumumab 20 mg/kg RP2D|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for recommended Phase 2 dose [RP2D] extension cohort.
1134494|NCT00474760|P4|Participant Flow|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134495|NCT00474760|P3|Participant Flow|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134496|NCT00474760|P2|Participant Flow|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134497|NCT00474760|P1|Participant Flow|Figitumumab 3 mg/kg|Figitumumab 3 milligram/kilogram (mg/kg) was supplied as a liquid solution administered as an intravenous (IV) infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134498|NCT00474760|O1|Outcome|Figitumumab 3, 6, 10, 20 mg/kg|Figitumumab 3, 6, 10, or 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation and RP2D extension cohorts.
1134499|NCT00474760|O1|Outcome|Figitumumab 3, 6, 10, 20 mg/kg|Figitumumab 3, 6, 10, or 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation and RP2D extension cohorts.
1134614|NCT00474630|B1|Baseline|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
1134500|NCT00474760|O1|Outcome|Figitumumab 3, 6, 10, 20 mg/kg|Figitumumab 3, 6, 10, or 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration for dose escalation, RP2D extension, and RP2D ACC and sarcoma extension cohorts, 4 weeks in duration for RP2D ESFT extension cohort).
1134501|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
1134502|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
1134503|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
1134504|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
1134505|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134506|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134507|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134508|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134509|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
1134510|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
1134511|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134512|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134513|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134514|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134515|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
1134516|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
1134517|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
1134518|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
1134519|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134520|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134521|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134522|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134523|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
1134524|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
1134525|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
1134615|NCT00474630|P2|Participant Flow|Placebo|Placebo
1134616|NCT00474630|P1|Participant Flow|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
1134526|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
1134527|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134528|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134529|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134530|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134531|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
1134532|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
1134533|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
1134534|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
1134535|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134536|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134537|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134538|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134539|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
1134540|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
1134541|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
1134542|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
1134543|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1135292|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
1134544|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134545|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134546|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134547|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
1134548|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
1134549|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
1134550|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
1134551|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134552|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134553|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134554|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134555|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
1134556|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
1134557|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
1134558|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
1134559|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134560|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134561|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134562|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134563|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
1134564|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
1134565|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
1134566|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
1134567|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134568|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134569|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134570|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1135293|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
1134571|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
1134572|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
1134573|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
1134574|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
1134575|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134576|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134577|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134578|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134579|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
1134617|NCT00474630|O2|Outcome|Placebo|Placebo
1134580|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
1134581|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
1134582|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
1134583|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134584|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134585|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134586|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134587|NCT00474760|O7|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
1134588|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ACC+Sarcoma|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D ACC and sarcoma extension cohort.
1134589|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D extension cohort.
1134590|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134591|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134592|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134593|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134594|NCT00474760|E7|Reported Event|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
1134595|NCT00474760|E6|Reported Event|Figitumumab 20 mg/kg RP2D ACC+Sarcoma|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D ACC and sarcoma extension cohort.
1134596|NCT00474760|E5|Reported Event|Figitumumab 20 mg/kg RP2D|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D extension cohort.
1134597|NCT00474760|E4|Reported Event|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134598|NCT00474760|E3|Reported Event|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134599|NCT00474760|E2|Reported Event|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134600|NCT00474760|E1|Reported Event|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
1134601|NCT00474708|B3|Baseline|Total|Total of all reporting groups
1134602|NCT00474708|B2|Baseline|SSRI or Conventional Antidepressant Group|Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg.
1134603|NCT00474708|B1|Baseline|Venlafaxine XR|75-225 mg per day
1134604|NCT00474708|P2|Participant Flow|SSRI or Conventional Antidepressant Group|Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg.
1134605|NCT00474708|P1|Participant Flow|Venlafaxine XR|75-225 mg per day
1134606|NCT00474708|O2|Outcome|SSRI or Conventional Antidepressant Group|Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg.
1134607|NCT00474708|O1|Outcome|Venlafaxine XR|75-225 mg per day
1134608|NCT00474708|O2|Outcome|SSRI or Conventional Antidepressant Group|Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg.
1134609|NCT00474708|O1|Outcome|Venlafaxine XR|75-225 mg per day
1134610|NCT00474708|E2|Reported Event|SSRI or Conventional Antidepressant Group|Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg.
1134611|NCT00474708|E1|Reported Event|Venlafaxine XR|75-225 mg per day
1134632|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
1134633|NCT00474630|O2|Outcome|Placebo|Placebo
1134634|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
1134635|NCT00474630|O2|Outcome|Placebo|Placebo
1134636|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
1134637|NCT00474630|O2|Outcome|Placebo|Placebo
1134638|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
1134639|NCT00474630|O2|Outcome|Placebo|Placebo
1134640|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
1134641|NCT00474630|O2|Outcome|Placebo|Placebo
1134642|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
1134643|NCT00474630|O2|Outcome|Placebo|Placebo
1134644|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
1134645|NCT00474630|O2|Outcome|Placebo|Placebo
1134646|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
1134647|NCT00474630|O2|Outcome|Placebo|Placebo
1134648|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
1134649|NCT00474630|O2|Outcome|Placebo|Placebo
1134650|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
1134651|NCT00474630|O2|Outcome|Placebo|Placebo
1134652|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
1134653|NCT00474630|O2|Outcome|Placebo|Placebo
1134654|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
1134655|NCT00474630|O2|Outcome|Placebo|Placebo
1134656|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
1134657|NCT00474630|O2|Outcome|Placebo|Placebo
1134658|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
1134659|NCT00474630|O2|Outcome|Placebo|Placebo
1134660|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
1134661|NCT00474630|O2|Outcome|Placebo|Placebo
1134662|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
1134663|NCT00474630|O2|Outcome|Placebo|Placebo
1134664|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/ day
1134665|NCT00474630|O2|Outcome|Placebo|Placebo
1134666|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
1134667|NCT00474630|E2|Reported Event|Placebo|Placebo
1134668|NCT00474630|E1|Reported Event|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg daily
1134669|NCT00474539|B3|Baseline|Total|Total of all reporting groups
1134670|NCT00474539|B2|Baseline|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
1134671|NCT00474539|B1|Baseline|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
1134672|NCT00474539|P2|Participant Flow|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
1134673|NCT00474539|P1|Participant Flow|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
1134674|NCT00474539|O2|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
1134675|NCT00474539|O1|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
1134676|NCT00474539|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
1134677|NCT00474539|O2|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
1134678|NCT00474539|O1|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
1134679|NCT00474539|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
1134680|NCT00474539|O2|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
1134681|NCT00474539|O1|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
1134682|NCT00474539|O4|Outcome|7vPnC After Toddler Dose|SParticipants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
1134683|NCT00474539|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
1134684|NCT00474539|O2|Outcome|7vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
1134685|NCT00474539|O1|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
1134686|NCT00474539|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
1134687|NCT00474539|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
1134688|NCT00474539|O2|Outcome|7vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
1134689|NCT00474539|O1|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
1134690|NCT00474539|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit.
1134691|NCT00474539|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit.
1134692|NCT00474539|O2|Outcome|7vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2)
1134693|NCT00474539|O1|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
1134695|NCT00474539|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
1134696|NCT00474539|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa and at the 6-month visit.
1134697|NCT00474539|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa and at the 6-month visit.
1134698|NCT00474539|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
1134699|NCT00474539|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
1134700|NCT00474539|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2-month visit.
1134701|NCT00474539|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2-month visit.
1134702|NCT00474539|O8|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
1134703|NCT00474539|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
1134704|NCT00474539|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa and at the 6-month visit.
1134705|NCT00474539|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa and at the 6-month visit.
1134706|NCT00474539|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
1134707|NCT00474539|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
1134708|NCT00474539|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2-month visit.
1134709|NCT00474539|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2-month visit.
1134710|NCT00474539|O2|Outcome|7vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
1134711|NCT00474539|O1|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
1134712|NCT00474539|E8|Reported Event|7vPnC 6-Month Follow-up|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit. Adverse events were collected for approximately six months after last visit
1134713|NCT00474539|E7|Reported Event|13vPnC 6-Month Follow-up|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit. Adverse events were collected for approximately six months after last visit
1134714|NCT00474539|E6|Reported Event|7vPnC Toddler Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit. Adverse events were collected for approximately one month after toddler dose.
1134715|NCT00474539|E5|Reported Event|13vPnC Toddler Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit. Adverse events were collected for approximately one month after toddler dose.
1134716|NCT00474539|E4|Reported Event|7vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit. Adverse events were collected from approximately one month after dose 3 to toddler dose.
1134717|NCT00474539|E3|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit. Adverse events were collected from approximately one month after dose 3 to toddler dose.
1134718|NCT00474539|E2|Reported Event|7vPnC Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits. Adverse events were collected from dose 1 to approximately one month after dose 3.
1134719|NCT00474539|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits. Adverse events were collected from dose 1 to approximately one month after dose 3.
1134720|NCT00474526|B18|Baseline|TOTAL|Total of all reporting groups
1134721|NCT00474526|B17|Baseline|LA6C (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
1134722|NCT00474526|B16|Baseline|LA6B (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age.
1134723|NCT00474526|B15|Baseline|LA6A (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 12 and a second dose of MenACWY at 15 months of age.
1135041|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
1134724|NCT00474526|B14|Baseline|LA5 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
1134725|NCT00474526|B13|Baseline|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
1134726|NCT00474526|B12|Baseline|LA3B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY.
1134727|NCT00474526|B11|Baseline|LA3A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
1134728|NCT00474526|B10|Baseline|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
1134729|NCT00474526|B9|Baseline|LA1B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
1134730|NCT00474526|B8|Baseline|LA1A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
1134731|NCT00474526|B7|Baseline|US4C (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 18 months of age.
1134732|NCT00474526|B6|Baseline|US4B (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age.
1134733|NCT00474526|B5|Baseline|US4A (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
1134734|NCT00474526|B4|Baseline|US3 (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
1134735|NCT00474526|B3|Baseline|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
1134736|NCT00474526|B2|Baseline|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
1134737|NCT00474526|B1|Baseline|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
1134738|NCT00474526|P17|Participant Flow|LA6C (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
1134739|NCT00474526|P16|Participant Flow|LA6B (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age.
1134740|NCT00474526|P15|Participant Flow|LA6A (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 12 and a second dose of MenACWY at 15 months of age.
1134741|NCT00474526|P14|Participant Flow|LA5 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
1134918|NCT00474487|B1|Baseline|Novartis MenACWY Vaccine (19 to 55 Years)|One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution.
1135294|NCT00473655|O3|Outcome|Placebo|Placebo
1134742|NCT00474526|P13|Participant Flow|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
1134743|NCT00474526|P12|Participant Flow|LA3B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY.
1134744|NCT00474526|P11|Participant Flow|LA3A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
1134745|NCT00474526|P10|Participant Flow|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
1134746|NCT00474526|P9|Participant Flow|LA1B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
1134747|NCT00474526|P8|Participant Flow|LA1A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
1134937|NCT00474487|E4|Reported Event|Licensed Polysaccharide Vaccine (56 to 65 Years)|One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered intramuscularly (Ages 56 to 65 Years)
1134748|NCT00474526|P7|Participant Flow|US4C (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 18 months of age.
1134749|NCT00474526|P6|Participant Flow|US4B (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age.
1134750|NCT00474526|P5|Participant Flow|US4A (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
1134751|NCT00474526|P4|Participant Flow|US3 (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
1134752|NCT00474526|P3|Participant Flow|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
1134753|NCT00474526|P2|Participant Flow|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
1134754|NCT00474526|P1|Participant Flow|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
1134755|NCT00474526|O2|Outcome|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
1134756|NCT00474526|O1|Outcome|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
1134757|NCT00474526|O2|Outcome|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
1134758|NCT00474526|O1|Outcome|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
1134919|NCT00474487|P4|Participant Flow|Licensed Polysaccharide Vaccine (56 to 65 Years)|One 0.5 mL dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered subcutaneously(Ages 56 to 65 Years) after reconstitution.
1134759|NCT00474526|O2|Outcome|LA3B (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY.
1134760|NCT00474526|O1|Outcome|LA3A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
1134761|NCT00474526|O2|Outcome|LA3B (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY.
1134762|NCT00474526|O1|Outcome|LA3A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
1134763|NCT00474526|O2|Outcome|LA1B (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
1134764|NCT00474526|O1|Outcome|LA1A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
1134765|NCT00474526|O2|Outcome|LA1B (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
1134766|NCT00474526|O1|Outcome|LA1A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
1134767|NCT00474526|O3|Outcome|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
1134768|NCT00474526|O2|Outcome|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
1134769|NCT00474526|O1|Outcome|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
1134770|NCT00474526|O2|Outcome|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
1134771|NCT00474526|O1|Outcome|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
1134772|NCT00474526|O2|Outcome|LA3A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
1134773|NCT00474526|O1|Outcome|LA1A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
1134774|NCT00474526|O2|Outcome|LA3A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
1134775|NCT00474526|O1|Outcome|LA1A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
1134794|NCT00474526|O2|Outcome|LA2 (Infant Vaccines Only) (12m)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
1134776|NCT00474526|O2|Outcome|LA3A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
1134777|NCT00474526|O1|Outcome|LA1A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
1134778|NCT00474526|O2|Outcome|LA3A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
1134779|NCT00474526|O1|Outcome|LA1A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
1134780|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
1134781|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines )|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
1134782|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
1134783|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines )|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
1134976|NCT00474240|O2|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg taken orally once daily
1134784|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
1134785|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines )|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
1134786|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
1134787|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines )|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
1134788|NCT00474526|O4|Outcome|LA4 (Infant Vaccines Only) (12m)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
1134789|NCT00474526|O3|Outcome|LA3 (Men ACWY-CRM + Infant Vaccines) (16m)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
1134790|NCT00474526|O2|Outcome|LA2 (Infant Vaccines Only) (12m)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
1134791|NCT00474526|O1|Outcome|LA1 (Men ACWY-CRM + Infant Vaccines) (12m)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
1134792|NCT00474526|O4|Outcome|LA4 (Infant Vaccines Only) (12m)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
1134793|NCT00474526|O3|Outcome|LA3 (Men ACWY-CRM + Infant Vaccines) (16m)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
1134914|NCT00474487|B5|Baseline|Total|Total of all reporting groups
1134795|NCT00474526|O1|Outcome|LA1 (Men ACWY-CRM + Infant Vaccines) (12m)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
1134796|NCT00474526|O4|Outcome|LA4 (Infant Vaccines Only) (12m)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
1134797|NCT00474526|O3|Outcome|LA3 (Men ACWY-CRM + Infant Vaccines) (16m)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
1134798|NCT00474526|O2|Outcome|LA2 (Infant Vaccines Only) (12m)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
1134799|NCT00474526|O1|Outcome|LA1 (Men ACWY-CRM + Infant Vaccines) (12m)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
1134800|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
1134801|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines )|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
1134802|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
1134977|NCT00474240|O1|Outcome|Placebo|Placebo capsule taken orally once daily
1134803|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
1134804|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
1134805|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
1134806|NCT00474526|O4|Outcome|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
1134807|NCT00474526|O3|Outcome|LA3 (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
1134808|NCT00474526|O2|Outcome|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
1134809|NCT00474526|O1|Outcome|LA1 (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
1134810|NCT00474526|O4|Outcome|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
1134811|NCT00474526|O3|Outcome|LA3 (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
1134812|NCT00474526|O2|Outcome|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
1134813|NCT00474526|O1|Outcome|LA1 (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
1135036|NCT00474123|B3|Baseline|Total|Total of all reporting groups
1135295|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
1134814|NCT00474526|O2|Outcome|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
1134815|NCT00474526|O1|Outcome|US1 (Men ACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
1134816|NCT00474526|O2|Outcome|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
1134817|NCT00474526|O1|Outcome|US1 (Men ACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
1134818|NCT00474526|O2|Outcome|LA3 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
1134819|NCT00474526|O1|Outcome|LA1 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
1134820|NCT00474526|O2|Outcome|LA3 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
1134821|NCT00474526|O1|Outcome|LA1 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
1134822|NCT00474526|O2|Outcome|US2 (Infant Vaccines Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
1134978|NCT00474240|E6|Reported Event|AEGR-733 10 mg + Atorvastatin 20 mg|One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
1134823|NCT00474526|O1|Outcome|US1 (MenACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
1134824|NCT00474526|O2|Outcome|US2 (Infant Vaccines Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
1134825|NCT00474526|O1|Outcome|US1 (MenACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
1134826|NCT00474526|O2|Outcome|LA3 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
1134827|NCT00474526|O1|Outcome|LA1 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
1134828|NCT00474526|O2|Outcome|US2 (Infant Vaccines Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
1134829|NCT00474526|O1|Outcome|US1 (MenACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age and received,as part of routine infant vaccination schedule, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group US1 was randomized into subgroups US1A and US1B.
1134830|NCT00474526|O4|Outcome|LA4+LA6 (Infant Vaccines Only)|"Groups Infant Vaccines only (LA4 and LA6) pooled.~LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received either:~One dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age (LA4).~Concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either one dose each of MenACWY at 12 and 15 months of age (LA6A); or one dose each of MenACWY at 13 and 15 months of age (LA6B) or one dose of MenACWY at 18 months of age (LA6C)."
1134831|NCT00474526|O3|Outcome|LA3+LA5 (Men ACWY-CRM + Infant Vaccines)|"Groups Men ACWY-CRM + Infant Vaccines (LA3 and LA5) pooled~LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age these infants were:~Recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib (LA3A)~Received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY (LA3B).~Received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V (LA5)."
1135037|NCT00474123|B2|Baseline|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
1134832|NCT00474526|O2|Outcome|US2+US4 (Infant Vaccines Only)|Groups Infant Vaccines only (US2+US4) pooled US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received either one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age (US2 and US4A) or received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 13 and and a second dose of MenACWY at 15 months of age (US4B) or one dose of MenACWY at 18 months of age (US4C).
1134833|NCT00474526|O1|Outcome|US1+US3 (Men ACWY-CRM + Infant Vaccines)|Groups MenACWY-CRM + Infant Vaccines (US1 +US3) pooled. US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants either received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age (US1A and US3) or received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a fourth dose of MenACWY at 13 months of age( US1B).
1134834|NCT00474526|O4|Outcome|LA4+LA6 (Infant Vaccines Only)|"Groups Infant Vaccines only (LA4 and LA6) pooled.~LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received either:~One dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age (LA4).~Concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either one dose each of MenACWY at 12 and 15 months of age (LA6A); or one dose each of MenACWY at 13 and 15 months of age (LA6B) or one dose of MenACWY at 18 months of age (LA6C)."
1134835|NCT00474526|O3|Outcome|LA3+LA5 (Men ACWY-CRM + Infant Vaccines)|"LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age these infants were:~Recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib (LA3A)~Received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY (LA3B).~Received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V (LA5)."
1134836|NCT00474526|O2|Outcome|US2+US4 (Infant Vaccines Only)|Groups Infant Vaccines only (US2+US4) pooled US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received either one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age (US2 and US4A) or received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age (US4B) or one dose of MenACWY at 18 months of age (US4C).
1134979|NCT00474240|E5|Reported Event|AEGR-733 5 mg + Atorvastatin 20 mg|One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
1134837|NCT00474526|O1|Outcome|US1+US3 (Men ACWY-CRM + Infant Vaccines)|Groups MenACWY-CRM + Infant Vaccines (US1 +US3) pooled. US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants either received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age (US1A and US3) or received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a fourth dose of MenACWY at 13 months of age( US1B).
1134838|NCT00474526|O4|Outcome|LA4 + LA6 (Infant Vaccines Only)|"Groups Infant Vaccines only (LA4 and LA6) pooled.~LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received either:~One dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age (LA4).~Concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either one dose each of MenACWY at 12 and 15 months of age (LA6A); or one dose each of MenACWY at 13 and 15 months of age (LA6B) or one dose of MenACWY at 18 months of age (LA6C)."
1134839|NCT00474526|O3|Outcome|LA3 + LA5 (Men ACWY-CRM + Infant Vaccines)|"Groups Men ACWY-CRM + Infant Vaccines (LA3 and LA5) pooled.~LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age these infants were:~Recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib (LA3A)~Received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY (LA3B).~Received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V (LA5)."
1134840|NCT00474526|O2|Outcome|US2 + US4 (Infant Vaccines Only)|"Groups Infant Vaccines only (US2+US4) pooled~US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received:~either one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age (US2 and US4A); or received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 13 and one dose at 15 months of age (US4B); or one dose of MenACWY at 18 months of age (US4C)."
1134841|NCT00474526|O1|Outcome|US1 + US3 (Men ACWY-CRM + Infant Vaccines)|"Groups MenACWY-CRM + Infant Vaccines (US1 +US3) pooled.~US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants either received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age (US1A and US3) or received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a fourth dose of MenACWY at 13 months of age( US1B)."
1134842|NCT00474526|O4|Outcome|LA6B (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and one dose at 15 months of age.
1134915|NCT00474487|B4|Baseline|Licensed Polysaccharide Vaccine (56 to 65 Years)|One 0.5 mL dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered subcutaneously(Ages 56 to 65 Years) after reconstitution.
1135296|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
1134843|NCT00474526|O3|Outcome|LA2 + LA4 + LA6A (Infant Vaccines Only)|Groups Infant Vaccines only (LA2, LA4 and LA6A) pooled. In all groups LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
1134844|NCT00474526|O2|Outcome|US4B (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and one dose at 15 months of age.
1134845|NCT00474526|O1|Outcome|US2 + US4A (Infant Vaccines Only)|Groups Infant Vaccines only (US2 and US4A) pooled. In both groups US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
1134846|NCT00474526|O13|Outcome|LA6C (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
1134847|NCT00474526|O12|Outcome|LA6B (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and one dose at 15 months of age.
1134848|NCT00474526|O11|Outcome|LA5 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
1134849|NCT00474526|O10|Outcome|LA3B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY.
1134850|NCT00474526|O9|Outcome|LA3A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
1134851|NCT00474526|O8|Outcome|LA2 + LA4 + LA6A (Infant Vaccines Only)|Groups Infant Vaccines only (LA2, LA4 and LA6A) pooled. In all groups LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
1134852|NCT00474526|O7|Outcome|LA1B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
1134853|NCT00474526|O6|Outcome|LA1A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
1134854|NCT00474526|O5|Outcome|US4C (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 18 months of age.
1134855|NCT00474526|O4|Outcome|US4B (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and one dose at 15 months of age.
1134856|NCT00474526|O3|Outcome|US2 + US4A (Infant Vaccines Only)|Groups Infant Vaccines only (US2 and US4A) pooled. In both groups US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
1134857|NCT00474526|O2|Outcome|US1A + US3 (MenACWY-CRM + Infant Vaccines)|Groups MenACWY-CRM + infant vaccines (US1A and US3) Pooled.In both groups US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
1134858|NCT00474526|O1|Outcome|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
1134859|NCT00474526|O11|Outcome|LA6B + LA6C (Infant Vaccines Only)|"Groups Infant Vaccines only LA6B and LA6C pooled.~Infant Vaccines only (LA6B): LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age (LA6B) or one dose of MenACWY at 18 months of age (LA6C)."
1134916|NCT00474487|B3|Baseline|Licensed Conjugate Vaccine (19 to 55 Years)|One 0.5 mL dose of the licensed meningococcal ACWY conjugate vaccine was administered intramuscularly (Ages 19 to 55 years).
1135038|NCT00474123|B1|Baseline|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
1134860|NCT00474526|O10|Outcome|LA5 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
1134861|NCT00474526|O9|Outcome|LA2 + LA4 + LA6A (Infant Vaccines Only)|Groups Infant Vaccines only (LA2, LA4 and LA6A) pooled. In all groups LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
1134862|NCT00474526|O8|Outcome|LA1B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
1134863|NCT00474526|O7|Outcome|LA1A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
1134864|NCT00474526|O6|Outcome|US4B + US4C (Infant Vaccines Only)|"Groups Infant Vaccines only (US4B and US4C) pooled.~Infant Vaccines only (US4B): US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either received one dose of MenACWY at 13 and and a second dose of MenACWY at 15 months of age (US4B); or one dose at 18 months of age (US4C)."
1134865|NCT00474526|O5|Outcome|US3 (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
1134866|NCT00474526|O4|Outcome|US2 + US4A (Infant Vaccines Only)|"Groups Infant Vaccines only (US2 and US4A) pooled.~In both groups US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age."
1134867|NCT00474526|O3|Outcome|US1A + US3 (MenACWY-CRM + Infant Vaccines)|Groups MenACWY-CRM + infant vaccines (US1A and US3) Pooled. In both groups US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
1134868|NCT00474526|O2|Outcome|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
1134869|NCT00474526|O1|Outcome|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
1134870|NCT00474526|O12|Outcome|LA6 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.
1134871|NCT00474526|O11|Outcome|LA5 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
1134872|NCT00474526|O10|Outcome|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
1134873|NCT00474526|O9|Outcome|LA3 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
1134874|NCT00474526|O8|Outcome|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
1134875|NCT00474526|O7|Outcome|LA1 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
1134876|NCT00474526|O6|Outcome|US4 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.
1134877|NCT00474526|O5|Outcome|US3 (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
1134917|NCT00474487|B2|Baseline|Novartis MenACWY Vaccine (56 to 65 Years)|One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution.
1135297|NCT00473655|O3|Outcome|Placebo|Placebo
1134878|NCT00474526|O4|Outcome|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
1134879|NCT00474526|O3|Outcome|US1 (MenACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
1134880|NCT00474526|O2|Outcome|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
1134881|NCT00474526|O1|Outcome|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
1134882|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
1134883|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines )|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
1134884|NCT00474526|O10|Outcome|LA6 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.
1134885|NCT00474526|O9|Outcome|LA5 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
1134886|NCT00474526|O8|Outcome|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
1134887|NCT00474526|O7|Outcome|LA3 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
1134888|NCT00474526|O6|Outcome|US4 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.
1134889|NCT00474526|O5|Outcome|US3 (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
1134890|NCT00474526|O4|Outcome|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
1134891|NCT00474526|O3|Outcome|US1 (MenACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
1134892|NCT00474526|O2|Outcome|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
1134893|NCT00474526|O1|Outcome|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
1134894|NCT00474526|O12|Outcome|LA6 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.
1134895|NCT00474526|O11|Outcome|LA5 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
1134896|NCT00474526|O10|Outcome|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
1134897|NCT00474526|O9|Outcome|LA3 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
1134898|NCT00474526|O8|Outcome|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
1134899|NCT00474526|O7|Outcome|LA1 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
1134900|NCT00474526|O6|Outcome|US4 (Infant Vaccines Only )|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.
1134901|NCT00474526|O5|Outcome|US3 (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
1134902|NCT00474526|O4|Outcome|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
1134903|NCT00474526|O3|Outcome|US1 (MenACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
1134904|NCT00474526|O2|Outcome|US1B (MenACWY-CRM + Infant Vaccines )|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
1134905|NCT00474526|O1|Outcome|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
1134906|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
1134907|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
1134908|NCT00474526|E6|Reported Event|LA6C|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
1134938|NCT00474487|E3|Reported Event|Licensed Conjugate Vaccine (19 to 55 Years)|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly in ages 19 to 55 years.
1134939|NCT00474487|E2|Reported Event|Novartis MenACWY Vaccine (56 to 65 Years)|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
1134909|NCT00474526|E5|Reported Event|LA2+4+6AB|Groups Infant Vaccines only (LA2, LA4, LA6A and LA6B) pooled. In all groups LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants either received: one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY at 15 months of age (LA2 and LA4) or received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose each of MenACWY at 12 and 15 months of age (LA6A); or one dose each of MenACWY at 13 and 15 months of age (LA6B).
1134910|NCT00474526|E4|Reported Event|LA1+LA3+LA5|"Groups Men ACWY-CRM + Infant Vaccines (LA1, LA3 and LA5) pooled~LA infants received MenACWY at 2 and 6 months of age; and DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received at 12 months of age pneumococcal conjugate vaccine, HAV, and MMR-V and concomitant third dose of MenACWY (LA1A) or a third dose of MenACWY at 13 months of age (LA1B).~LA infants received MenACWY, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. At 12 months of age these infants received pneumococcal conjugate vaccine, HAV, and MMR-V and received:~Fourth dose of MenACWY concomitantly with DTaP and Hib at 16 months of age (LA3A)~DTaP and Hib at 16 months and fourth dose of MenACWY at 17 months of age (LA3B).~Concomitantly the fourth dose of MenACWY (LA5)."
1134911|NCT00474526|E3|Reported Event|US4C|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 18 months of age.
1134912|NCT00474526|E2|Reported Event|US2+US4A+US4B|"Groups Infant Vaccines only (US2, US4A, and US4B) pooled.~In both groups US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received:~One dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age ( US2 and US4A).~Concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age (US4B)"
1134913|NCT00474526|E1|Reported Event|US1+US3|Groups MenACWY-CRM + Infant Vaccines (US1 +US3) pooled. US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants either received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age (US1A and US3) or received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a fourth dose of MenACWY at 13 months of age( US1B).
1134920|NCT00474487|P3|Participant Flow|Licensed Conjugate Vaccine (19 to 55 Years)|One 0.5 mL dose of the licensed meningococcal ACWY conjugate vaccine was administered intramuscularly (Ages 19 to 55 years).
1134921|NCT00474487|P2|Participant Flow|Novartis MenACWY Vaccine (56 to 65 Years)|One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution.
1134922|NCT00474487|P1|Participant Flow|Novartis MenACWY Vaccine (19 to 55 Years)|One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution.
1134923|NCT00474487|O2|Outcome|Licensed Polysaccharide Vaccine|One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered intramuscularly.
1134924|NCT00474487|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
1134925|NCT00474487|O2|Outcome|Licensed Conjugate Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
1134926|NCT00474487|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
1134927|NCT00474487|O2|Outcome|Licensed Polysaccharide Vaccine|One dose of the licensed meningococcal ACWY polysaccharide vaccine administered subcutaneously.
1134928|NCT00474487|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
1134929|NCT00474487|O2|Outcome|Licensed Conjugate Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
1134930|NCT00474487|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
1134931|NCT00474487|O2|Outcome|Licensed Polysaccharide Vaccine|One dose of the licensed meningococcal ACWY polysaccharide vaccine administered subcutaneously.
1134932|NCT00474487|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
1134933|NCT00474487|O2|Outcome|Licensed Conjugate Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
1134934|NCT00474487|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
1134935|NCT00474487|O2|Outcome|Licensed Conjugate Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
1134936|NCT00474487|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
1140886|NCT00460239|O1|Outcome|Placebo 0 mg|
1134940|NCT00474487|E1|Reported Event|Novartis MenACWY Vaccine (19 to 55 Years)|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
1134941|NCT00474383|B1|Baseline|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
1134942|NCT00474383|P2|Participant Flow|Arbitarone Acetate (Extension)|Participants who received abiraterone acetate 1000 milligram (mg) capsule or tablet orally, once daily continuously in 28-day cycles up to 12 cycles, along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily in Main study, continued the same treatment until disease progression, death, or end of study (Week 148).
1134943|NCT00474383|P1|Participant Flow|Abiraterone Acetate (Main Study)|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycles up to 12 cycles, along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
1134944|NCT00474383|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
1134945|NCT00474383|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
1134946|NCT00474383|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
1134947|NCT00474383|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
1134948|NCT00474383|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
1134949|NCT00474383|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
1134950|NCT00474383|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
1134951|NCT00474383|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
1135039|NCT00474123|P2|Participant Flow|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
1134952|NCT00474383|E1|Reported Event|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
1134953|NCT00474240|B7|Baseline|Total|Total of all reporting groups
1134954|NCT00474240|B6|Baseline|AEGR-733 10 mg + Atorvastatin 20 mg|One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
1134955|NCT00474240|B5|Baseline|AEGR-733 5 mg + Atorvastatin 20 mg|One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
1134956|NCT00474240|B4|Baseline|AEGR-733 10 mg|AEGR-733 10 mg taken orally once daily
1134957|NCT00474240|B3|Baseline|AEGR-733 5 mg|AEGR-733 5 mg taken orally once daily
1134958|NCT00474240|B2|Baseline|Atorvastatin 20 mg|Atorvastatin 20 mg taken orally once daily
1134959|NCT00474240|B1|Baseline|Placebo|Placebo capsule taken orally once daily
1134960|NCT00474240|P6|Participant Flow|AEGR-733 10 mg + Atorvastatin 20 mg|One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
1134961|NCT00474240|P5|Participant Flow|AEGR-733 5 mg + Atorvastatin 20 mg|One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
1134962|NCT00474240|P4|Participant Flow|AEGR-733 10 mg|AEGR-733 10 mg taken orally once daily
1134963|NCT00474240|P3|Participant Flow|AEGR-733 5 mg|AEGR-733 5 mg taken orally once daily
1134964|NCT00474240|P2|Participant Flow|Atorvastatin 20 mg|Atorvastatin 20 mg taken orally once daily
1134965|NCT00474240|P1|Participant Flow|Placebo|Placebo capsule taken orally once daily
1134966|NCT00474240|O6|Outcome|AEGR-733 10 mg + Atorvastatin 20 mg|One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
1134967|NCT00474240|O5|Outcome|AEGR-733 5 mg + Atorvastatin 20 mg|One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
1134968|NCT00474240|O4|Outcome|AEGR-733 10 mg|AEGR-733 10 mg taken orally once daily
1134969|NCT00474240|O3|Outcome|AEGR-733 5 mg|AEGR-733 5 mg taken orally once daily
1134970|NCT00474240|O2|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg taken orally once daily
1134971|NCT00474240|O1|Outcome|Placebo|Placebo capsule taken orally once daily
1134972|NCT00474240|O6|Outcome|AEGR-733 10 mg + Atorvastatin 20 mg|One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
1134973|NCT00474240|O5|Outcome|AEGR-733 5 mg + Atorvastatin 20 mg|One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
1134974|NCT00474240|O4|Outcome|AEGR-733 10 mg|AEGR-733 10 mg taken orally once daily
1134975|NCT00474240|O3|Outcome|AEGR-733 5 mg|AEGR-733 5 mg taken orally once daily
1140887|NCT00460239|O8|Outcome|Buprenorphine 60 mg|
1134980|NCT00474240|E4|Reported Event|AEGR-733 10 mg|AEGR-733 10 mg taken orally once daily
1134981|NCT00474240|E3|Reported Event|AEGR-733 5 mg|AEGR-733 5 mg taken orally once daily
1134982|NCT00474240|E2|Reported Event|Atorvastatin 20 mg|Atorvastatin 20 mg taken orally once daily
1134983|NCT00474240|E1|Reported Event|Placebo|Placebo capsule taken orally once daily
1134984|NCT00474201|B1|Baseline|Gemfibrozil (GF) Alone Followed by GF + Lopinavir-ritonavir|Subjects received a single 600 mg dose of gemfibrozil before- and after receiving lopinavir-ritonar 400mg/100mg twice daily, for 14.5 days. After each gemfibrozil dose, blood samples were collected for the determination of gemfibrozil plasma concentrations. The plasma concentrations were then used to determine gemfibrozil pharmacokinetic (PK) parameters values such as area under the concentration vs. time curve (AUC). PK Parameter values were then compared pre- and post lopinavir-ritonavir administration.
1134985|NCT00474201|P1|Participant Flow|Gemfibrozil (GF) Alone Followed by GF+ Lopinavir-ritonavir|Subjects received a single 600 mg dose of gemfibrozil before and after receiving lopinavir-ritonar 400mg/100mg twice daily, for 14.5 days. After each gemfibrozil dose, blood samples were collected to determine gemfibrozil plasma concentrations. These plasma concentrations were then used to determine gemfibrozil pharmacokinetic (PK) parameter values such as area under the concentration vs. time curve (AUC). Gemfibrozil PK parameter values were then compared before- and after lopinavir-ritonavir administration.
1134986|NCT00474201|O2|Outcome|Gemfibrozil + Lopinavir-ritonavir|After receiving lopinavir-ritonavir (400mg/100mg twice daily) for 14.5 days, subjects received a single 600 mg dose of gemfibrozil and serial blood samples were collected over a 24 hr. post-dose period to determine pharmacokinetic parameter values. Area under the concentrations vs. time curve from time zero to infinity (i.e. total drug exposure) was the primary pharmacokinetic parameter of interest.
1134987|NCT00474201|O1|Outcome|Gemfibrozil Alone (Control Group)|"Subjects received a single 600 mg dose of gemfibrozil and serial blood samples were collected over a 24 hr. post-dose period to determine pharmacokinetic parameter values. Area under the concentrations vs. time curve from time zero to infinity (i.e. total drug exposure) was the primary pharmacokinetic parameter of interest. After completing participation in this control group, each subject crossed over to received lopinavir-ritonavir (400mg/100mg twice daily) for 14.5 days. Therefore, each subject served as their own control. Hence there were two groups of data analyzed, but each group consisted of the same subjects (tested under different conditions)."
1134988|NCT00474201|E1|Reported Event|Gemfibrozil (GF) Alone Followed by GF + Lopinavir-ritonavir|Subjects received a single 600 mg dose of gemfibrozil before- and after receiving lopinavir-ritonar 400mg/100mg twice daily, for 14.5 days. After each gemfibrozil dose, blood samples were collected for the determination of gemfibrozil plasma concentrations. The plasma concentrations were then used to determine gemfibrozil pharmacokinetic (PK) parameters values such as area under the concentration vs. time curve (AUC). PK Parameter values were then compared pre- and post lopinavir-ritonavir administration.
1134989|NCT00474188|B1|Baseline|Lenalidomide in Combination With Dexamethasone|Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
1134990|NCT00474188|P1|Participant Flow|Lenalidomide in Combination With Dexamethasone|Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
1135040|NCT00474123|P1|Participant Flow|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
1135298|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
1134991|NCT00474188|O1|Outcome|Lenalidomide in Combination With Dexamethasone|Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
1134992|NCT00474188|O1|Outcome|Lenalidomide in Combination With Dexamethasone|Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
1134993|NCT00474188|O1|Outcome|Lenalidomide in Combination With Dexamethasone|Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
1134994|NCT00474188|O1|Outcome|Lenalidomide in Combination With Dexamethasone|Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
1134995|NCT00474188|O1|Outcome|Lenalidomide in Combination With Dexamethasone|Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
1134996|NCT00474175|B4|Baseline|Total|Total of all reporting groups
1134997|NCT00474175|B3|Baseline|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
1134998|NCT00474175|B2|Baseline|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
1134999|NCT00474175|B1|Baseline|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
1135000|NCT00474175|P3|Participant Flow|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
1135001|NCT00474175|P2|Participant Flow|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
1135002|NCT00474175|P1|Participant Flow|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
1135003|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
1135004|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
1135005|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
1135006|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
1135007|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
1135008|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
1135009|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
1135010|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
1135011|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
1135012|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
1135013|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
1135014|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
1135015|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
1135016|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
1135017|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
1135018|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
1135019|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
1135020|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
1135021|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
1135022|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
1135023|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
1135024|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
1135025|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
1135026|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
1135027|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
1135028|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
1135029|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
1135030|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
1135031|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
1135032|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
1135033|NCT00474175|E3|Reported Event|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
1135034|NCT00474175|E2|Reported Event|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
1135035|NCT00474175|E1|Reported Event|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
1135043|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
1135044|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
1135045|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
1135046|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
1135047|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
1135048|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
1135049|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
1135050|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
1135051|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
1135052|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
1135053|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
1135054|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
1135055|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
1135056|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
1135057|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
1135058|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
1135059|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
1135060|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
1135061|NCT00474123|E2|Reported Event|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
1140888|NCT00460239|O7|Outcome|Buprenorphine 48 mg|
1135062|NCT00474123|E1|Reported Event|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
1135063|NCT00474058|B3|Baseline|Total|Total of all reporting groups
1135064|NCT00474058|B2|Baseline|Placebo|Placebo transdermal patch
1135065|NCT00474058|B1|Baseline|Rotigotine|Rotigotine transdermal patch
1135066|NCT00474058|P2|Participant Flow|Placebo|Placebo transdermal patch
1135067|NCT00474058|P1|Participant Flow|Rotigotine|Rotigotine transdermal patch
1135068|NCT00474058|O2|Outcome|Placebo|Placebo transdermal patch
1135069|NCT00474058|O1|Outcome|Rotigotine|Rotigotine transdermal patch
1135070|NCT00474058|O2|Outcome|Placebo|Placebo transdermal patch
1135071|NCT00474058|O1|Outcome|Rotigotine|Rotigotine transdermal patch
1135072|NCT00474058|O2|Outcome|Placebo|Placebo transdermal patch
1135073|NCT00474058|O1|Outcome|Rotigotine|Rotigotine transdermal patch
1135074|NCT00474058|O2|Outcome|Placebo|Placebo transdermal patch
1135075|NCT00474058|O1|Outcome|Rotigotine|Rotigotine transdermal patch
1135076|NCT00474058|E2|Reported Event|Placebo|Placebo transdermal patch
1135077|NCT00474058|E1|Reported Event|Rotigotine|Rotigotine transdermal patch
1135078|NCT00474045|B3|Baseline|Total|Total of all reporting groups
1135079|NCT00474045|B2|Baseline|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135080|NCT00474045|B1|Baseline|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135081|NCT00474045|P2|Participant Flow|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135082|NCT00474045|P1|Participant Flow|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135083|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135190|NCT00473889|E2|Reported Event|Placebo + Paclitaxel + Carboplatin|Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
1135084|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135085|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135086|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135087|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135088|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135246|NCT00473746|O2|Outcome|Phase I Dose Escalation (500mg)|The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
1135320|NCT00473642|O2|Outcome|50% Fluence PDT|Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
1135089|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135090|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135091|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135092|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135093|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135094|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135095|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135191|NCT00473889|E1|Reported Event|Vorinostat + Paclitaxel + Carboplatin|Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
1135096|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135097|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135098|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135099|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135100|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135101|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135247|NCT00473746|O1|Outcome|Phase I Dose Escalation (250mg)|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods.
1135102|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135103|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135104|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135105|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135106|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135107|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135108|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135109|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135110|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135111|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135112|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135113|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135114|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135248|NCT00473746|O4|Outcome|Phase I Dose Escalation (1000mg)|The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
1135115|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135116|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135117|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135118|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135119|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135120|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135121|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135122|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135123|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135124|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135125|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135126|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135127|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135249|NCT00473746|O3|Outcome|Phase I Dose Escalation (750mg)|The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
1135128|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135129|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135130|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135131|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135132|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135133|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135134|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135135|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135136|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135137|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135138|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135139|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135140|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135250|NCT00473746|O2|Outcome|Phase I Dose Escalation (500mg)|The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
1135141|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135142|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135143|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135144|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135145|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135146|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135147|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135148|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135149|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135150|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135151|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135152|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135153|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135251|NCT00473746|O1|Outcome|Phase I Dose Escalation (250mg)|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods.
1135154|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135155|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135156|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135157|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135158|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135159|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135160|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135161|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135162|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135163|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135164|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135165|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135166|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135252|NCT00473746|O4|Outcome|Phase I Dose Escalation (1000mg)|The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
1135167|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135168|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135169|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135170|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135171|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135172|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135173|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135174|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135175|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135176|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135177|NCT00474045|E2|Reported Event|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135178|NCT00474045|E1|Reported Event|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
1135179|NCT00473889|B3|Baseline|Total|Total of all reporting groups
1135180|NCT00473889|B2|Baseline|Placebo + Paclitaxel + Carboplatin|Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
1135253|NCT00473746|O3|Outcome|Phase I Dose Escalation (750mg)|The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
1140889|NCT00460239|O6|Outcome|Buprenorphine 32 mg|
1135181|NCT00473889|B1|Baseline|Vorinostat + Paclitaxel + Carboplatin|Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
1135182|NCT00473889|P2|Participant Flow|Placebo + Paclitaxel + Carboplatin|Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
1135183|NCT00473889|P1|Participant Flow|Vorinostat + Paclitaxel + Carboplatin|Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
1135184|NCT00473889|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
1135185|NCT00473889|O1|Outcome|Vorinostat + Paclitaxel + Carboplatin|Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
1135186|NCT00473889|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
1135187|NCT00473889|O1|Outcome|Vorinostat + Paclitaxel + Carboplatin|Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
1135188|NCT00473889|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
1135189|NCT00473889|O1|Outcome|Vorinostat + Paclitaxel + Carboplatin|Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
1135192|NCT00473876|B3|Baseline|Total|Total of all reporting groups
1135193|NCT00473876|B2|Baseline|Placebo|Matched Placebo for 4 months
1135194|NCT00473876|B1|Baseline|Metformin|Receiving Metformin for 4 months with a target dose of 1000mg twice a day
1135195|NCT00473876|P2|Participant Flow|Placebo|Matched Placebo for 4 months
1135196|NCT00473876|P1|Participant Flow|Metformin|Receiving Metformin for 4 months with a target dose of 1000mg twice a day
1135197|NCT00473876|O2|Outcome|Placebo|Impact of placebo on VE/VCO2 slope.
1135198|NCT00473876|O1|Outcome|Metformin Arm|Assess impact of metformin on submaximal exercise parameters- VE/VCO2 slope (pre-specified end point). The mean VE/VCO2 difference was compared between baseline and after 4 months of metformin.
1135199|NCT00473876|O2|Outcome|Placebo|Peak VO2 mean difference between baseline and after 4 months of placebo
1135200|NCT00473876|O1|Outcome|Metformin Arm|Peak VO2 mean difference between baseline and after 4 months of metformin was analysed
1135201|NCT00473876|E2|Reported Event|Placebo|Matched Placebo for 4 months
1135202|NCT00473876|E1|Reported Event|Metformin|Receiving Metformin for 4 months with a target dose of 1000mg twice a day
1135203|NCT00473837|B3|Baseline|Total|Total of all reporting groups
1135204|NCT00473837|B2|Baseline|Control|Subjects initially treated with Co-artemether or Chloroquine & Sulphadoxine/Pyrimathamine, and then continued on weekly placebo till day 90
1135205|NCT00473837|B1|Baseline|Treatment|Subjects initially treated with Co-artemether or Chloroquine &Sulphadoxine/Pyrimathamine, and then continued on weekly chloroquine till day 90
1135206|NCT00473837|P2|Participant Flow|Control|Subjects initially treated with Co-artemether or Cholroquine & Sulphadoxine/Pyrimethamine, and then continued on weekly placebo till day 90.
1135207|NCT00473837|P1|Participant Flow|Treatment|Subjects initially treated with Corartemether or Cholroquine & Sulphadoxine/Pyrimethamine, and then continued on weekly chloroquine till day 90.
1135208|NCT00473837|O2|Outcome|Control|"Subjects initially treated with Co-arthemeter, and then continued on weekly placebo till day 90~Placebo: The placebo is an orange syrup in a 60ml amber coloured glass bottle containing sucrose syrup base. The syrup was prepared by the Pharmacy department of the Royal Victorial Teaching Hospital and Atlantic Pharmaceuticals Limited, Banjul"
1135254|NCT00473746|O2|Outcome|Phase I Dose Escalation (500mg)|The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
1140890|NCT00460239|O5|Outcome|Buprenorphine 16 mg|
1135209|NCT00473837|O1|Outcome|Treatment|"Subjects initially treated with Co-arthemeter, and then continued on weekly chloroquine till day 90~Chloroquine: This is an orange syrup in a 60ml amber coloured glass bottle containing 50mg of chloroquine base per 5mls as the chloroquine phosphate. The syrup was manufactured by Medreich Sterilab Ltd, Avalahalli, Bangalore, India. Chloroquine: weekly treatment of 7.5mg/kg for 90 days"
1135210|NCT00473837|E2|Reported Event|Control|Subjects initially treated with Co-arthemeter, and then continued on weekly placebo till day 90
1135211|NCT00473837|E1|Reported Event|Treatment|Subjects initially treated with Co-arthemeter, and then continued on weekly chloroquine till day 90
1135212|NCT00473824|B3|Baseline|Total|Total of all reporting groups
1135213|NCT00473824|B2|Baseline|No Civacir (Control)|Observation on standard site specific routine post-transplant immunosuppressant therapy without infusions of Hepatitis C Immune Globulin Intravenous (Human) 5%.
1135214|NCT00473824|B1|Baseline|Civacir Treatment Arm|Subjects received standard site specific routine post-transplant immunosuppressant therapy with Hepatitis C Immune Globulin Intravenous (Human) 5% [Civacir], 18 infusions total, per schedule, of Civacir 300 or 400 mg/kg of body weight.
1135215|NCT00473824|P2|Participant Flow|No Civacir (Control)|Observation on standard site specific routine post-transplant immunosuppressant therapy without infusions of Hepatitis C Immune Globulin Intravenous (Human) 5%.
1135216|NCT00473824|P1|Participant Flow|Civacir Treatment Arm|Subjects received standard site specific routine post-transplant immunosuppressant therapy with Hepatitis C Immune Globulin Intravenous (Human) 5% [Civacir], 18 infusions total, per schedule, of Civacir 300 or 400 mg/kg of body weight.
1135217|NCT00473824|O2|Outcome|No Civacir (Control)|Observation on standard site specific routine post-tranplant immunosuppressant therapy without infusions of Hepatitis C Immune Globulin Intravenous (Human) 5%. Standard post-tranplant therapy includes immunosuppressive agents.
1135218|NCT00473824|O1|Outcome|Civacir Treatment Arm|Subjects received Hepatitis C Immune Globulin Intravenous (Human) 5% [Civacir], 18 infusions total, per schedule, of Civacir 300 or 400 mg/kg of body weight, in addition to their standard site specific routine post-tranplant immunosuppressant therapy.
1135219|NCT00473824|E2|Reported Event|No Civacir (Control)|Observation on standard site specific routine post-transplant immunosuppressant therapy without infusions of Hepatitis C Immune Globulin Intravenous (Human) 5%.
1135220|NCT00473824|E1|Reported Event|Civacir Treatment Arm|Subjects received standard site specific routine post-transplant immunosuppressant therapy with Hepatitis C Immune Globulin Intravenous (Human) 5% [Civacir], 18 infusions total, per schedule, of Civacir 300 or 400 mg/kg of body weight.
1135221|NCT00473746|B6|Baseline|Total|Total of all reporting groups
1135222|NCT00473746|B5|Baseline|Phase 2 1000 MG/DAY|Abiraterone acetate
1135223|NCT00473746|B4|Baseline|Phase 1 1000 MG/DAY|Abiraterone acetate
1135224|NCT00473746|B3|Baseline|Phase 1 750 MG/DAY|Abiraterone acetate
1135225|NCT00473746|B2|Baseline|Phase 1 500 MG/DAY|Abiraterone acetate
1135226|NCT00473746|B1|Baseline|Phase 1 250 MG/DAY|Abiraterone acetate
1135227|NCT00473746|P5|Participant Flow|Phase 2 1000 MG/DAY|Abiraterone acetate
1135228|NCT00473746|P4|Participant Flow|Phase 1 1000 MG/DAY|Abiraterone acetate
1135229|NCT00473746|P3|Participant Flow|Phase 1 750 MG/DAY|Abiraterone acetate
1135230|NCT00473746|P2|Participant Flow|Phase 1 500 MG/DAY|Abiraterone acetate
1135231|NCT00473746|P1|Participant Flow|Phase 1 250 MG/DAY|Abiraterone acetate
1135232|NCT00473746|O1|Outcome|Phase II Dose Treatment|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods , if no dose limiting toxicity (DLT) was documented at this dose, the dose will be escalated to next dose levels 500, 750, and 1000 mg/day. The dose escalation will continue to a maximum of 1000 mg/day until maximum tolerated dose (MTD) and a recommended Phase II dose was established.
1135233|NCT00473746|O1|Outcome|Phase II Dose Treatment|Abiraterone acetate 1000 mg daily and concurrent prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) under fasted conditions upto 10 cycles of therapy.
1135234|NCT00473746|O1|Outcome|Phase II Dose Treatment|Abiraterone acetate 1000 mg daily and concurrent prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) under fasted conditions upto 10 cycles of therapy.
1135235|NCT00473746|O1|Outcome|Phase II Dose Treatment|Abiraterone acetate 1000 mg daily and concurrent prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) under fasted conditions upto 10 cycles of therapy.
1135236|NCT00473746|O1|Outcome|Phase II Dose Treatment|Abiraterone acetate 1000 mg daily and concurrent prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) under fasted conditions upto 10 cycles of therapy.
1135237|NCT00473746|O1|Outcome|Phase II Dose Treatment|Abiraterone acetate 1000 mg daily and concurrent prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) under fasted conditions upto 10 cycles of therapy.
1135238|NCT00473746|O1|Outcome|Phase II Dose Treatment|Abiraterone acetate 1000 mg daily and concurrent prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) under fasted conditions upto 10 cycles of therapy.
1135239|NCT00473746|O1|Outcome|Phase II Dose Treatment|Abiraterone acetate 1000 mg daily and concurrent prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) under fasted conditions upto 10 cycles of therapy.
1135240|NCT00473746|O4|Outcome|Phase I Dose Escalation (1000mg)|The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
1135241|NCT00473746|O3|Outcome|Phase I Dose Escalation (750mg)|The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
1135242|NCT00473746|O2|Outcome|Phase I Dose Escalation (500mg)|The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
1135243|NCT00473746|O1|Outcome|Phase I Dose Escalation (250mg)|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods.
1135244|NCT00473746|O4|Outcome|Phase I Dose Escalation (1000mg)|The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
1135245|NCT00473746|O3|Outcome|Phase I Dose Escalation (750mg)|The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
1135318|NCT00473642|P1|Participant Flow|Standard Fluence PDT|Standard Fluence Photodynamic Therapy combined with ranibizumab
1135255|NCT00473746|O1|Outcome|Phase I Dose Escalation (250mg)|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods.
1135256|NCT00473746|O4|Outcome|Phase I Dose Escalation (1000mg)|The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
1135257|NCT00473746|O3|Outcome|Phase I Dose Escalation (750mg)|The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
1135258|NCT00473746|O2|Outcome|Phase I Dose Escalation (500mg)|The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
1135259|NCT00473746|O1|Outcome|Phase I Dose Escalation (250mg)|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods.
1135260|NCT00473746|O4|Outcome|Phase I Dose Escalation (1000mg)|The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
1135261|NCT00473746|O3|Outcome|Phase I Dose Escalation (750mg)|The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
1135262|NCT00473746|O2|Outcome|Phase I Dose Escalation (500mg)|The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
1135263|NCT00473746|O1|Outcome|Phase I Dose Escalation (250mg)|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods.
1135264|NCT00473746|O4|Outcome|Phase I Dose Escalation (1000mg)|The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
1135265|NCT00473746|O3|Outcome|Phase I Dose Escalation (750mg)|The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
1135266|NCT00473746|O2|Outcome|Phase I Dose Escalation (500mg)|The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
1135267|NCT00473746|O1|Outcome|Phase I Dose Escalation (250mg)|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods.
1135268|NCT00473746|O1|Outcome|Phase II Dose Treatment|Abiraterone acetate 1000 mg daily and concurrent prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) under fasted conditions upto 10 cycles of therapy.
1135269|NCT00473746|O1|Outcome|Phase I Dose Escalation|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods , if no dose limiting toxicity (DLT) was documented at this dose, the dose will be escalated to next dose levels 500, 750, and 1000 mg/day. The dose escalation will continue to a maximum of 1000 mg/day until maximum tolerated dose (MTD) and a recommended Phase II dose was established.
1135270|NCT00473746|E5|Reported Event|Phase 2 1000 MG/DAY|Abiraterone acetate
1135271|NCT00473746|E4|Reported Event|Phase 1 1000 MG/DAY|Abiraterone acetate
1135272|NCT00473746|E3|Reported Event|Phase 1 750 MG/DAY|Abiraterone acetate
1135273|NCT00473746|E2|Reported Event|Phase 1 500 MG/DAY|Abiraterone acetate
1135274|NCT00473746|E1|Reported Event|Phase 1 250 MG/DAY|Abiraterone acetate
1135275|NCT00473655|B4|Baseline|Total|Total of all reporting groups
1135276|NCT00473655|B3|Baseline|Placebo|Placebo
1135277|NCT00473655|B2|Baseline|Rosuvastatin 20 mg|Rosuvastatin 20 mg
1135278|NCT00473655|B1|Baseline|Rosuvastatin 10 mg|Rosuvastatin 10 mg
1135279|NCT00473655|P3|Participant Flow|Placebo|Placebo
1135280|NCT00473655|P2|Participant Flow|Rosuvastatin 20 mg|Rosuvastatin 20 mg
1135281|NCT00473655|P1|Participant Flow|Rosuvastatin 10 mg|Rosuvastatin 10 mg
1135282|NCT00473655|O3|Outcome|Placebo|Placebo
1135283|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
1135284|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
1135285|NCT00473655|O3|Outcome|Placebo|Placebo
1135286|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
1135287|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
1135299|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
1135300|NCT00473655|O3|Outcome|Placebo|Placebo
1135301|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
1135302|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
1135303|NCT00473655|O3|Outcome|Placebo|Placebo
1135304|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
1135305|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
1135306|NCT00473655|O3|Outcome|Placebo|Placebo
1135307|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
1135308|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
1135309|NCT00473655|E3|Reported Event|Placebo|Placebo
1135310|NCT00473655|E2|Reported Event|Rosuvastatin 20 mg|Rosuvastatin 20 mg
1135311|NCT00473655|E1|Reported Event|Rosuvastatin 10 mg|Rosuvastatin 10 mg
1135312|NCT00473642|B4|Baseline|Total|Total of all reporting groups
1135313|NCT00473642|B3|Baseline|Ranibizumab|Ranibizumab monotherapy
1135314|NCT00473642|B2|Baseline|50% Fluence PDT|Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
1135315|NCT00473642|B1|Baseline|Standard Fluence PDT|Standard Fluence Photodynamic Therapy combined with ranibizumab
1135316|NCT00473642|P3|Participant Flow|Ranibizumab|Ranibizumab monotherapy
1135317|NCT00473642|P2|Participant Flow|50% Fluence PDT|Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
1135321|NCT00473642|O1|Outcome|Standard Fluence PDT|Standard Fluence Photodynamic Therapy combined with ranibizumab
1135322|NCT00473642|E3|Reported Event|Ranibizumab|Ranibizumab monotherapy
1135323|NCT00473642|E2|Reported Event|50% Fluence PDT|Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
1135324|NCT00473642|E1|Reported Event|Standard Fluence PDT|Standard Fluence Photodynamic Therapy combined with ranibizumab
1135325|NCT00473590|B3|Baseline|Total|Total of all reporting groups
1135326|NCT00473590|B2|Baseline|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
1135327|NCT00473590|B1|Baseline|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
1135328|NCT00473590|P2|Participant Flow|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
1135329|NCT00473590|P1|Participant Flow|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
1135330|NCT00473590|O2|Outcome|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
1135331|NCT00473590|O1|Outcome|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
1135332|NCT00473590|O2|Outcome|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
1135333|NCT00473590|O1|Outcome|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
1135334|NCT00473590|O2|Outcome|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
1135335|NCT00473590|O1|Outcome|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
1135336|NCT00473590|O2|Outcome|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
1136335|NCT00469508|O2|Outcome|Placebo|Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
1135337|NCT00473590|O1|Outcome|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
1135338|NCT00473590|O2|Outcome|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
1135339|NCT00473590|O1|Outcome|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
1135340|NCT00473590|O2|Outcome|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
1140891|NCT00460239|O4|Outcome|Buprenorphine 8 mg|
1135341|NCT00473590|O1|Outcome|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
1135342|NCT00473590|E2|Reported Event|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
1135343|NCT00473590|E1|Reported Event|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
1135344|NCT00473564|B1|Baseline|TORS Candidates|Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
1135345|NCT00473564|P1|Participant Flow|TORS Candidates|Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
1135346|NCT00473564|O1|Outcome|TORS Candidates|Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
1135347|NCT00473564|O1|Outcome|TORS Candidates|Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
1135348|NCT00473564|E1|Reported Event|TORS Candidates|Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
1135349|NCT00473512|B6|Baseline|Total|Total of all reporting groups
1135350|NCT00473512|B5|Baseline|2000 mg/Day|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
1135351|NCT00473512|B4|Baseline|1000 mg/Day|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
1135352|NCT00473512|B3|Baseline|750 mg/Day|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
1135353|NCT00473512|B2|Baseline|500 mg/Day|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
1135354|NCT00473512|B1|Baseline|250 mg/Day|Abiraterone acetate 250 mg capsule administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
1135355|NCT00473512|P5|Participant Flow|2000 mg/Day|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
1135356|NCT00473512|P4|Participant Flow|1000 mg/Day|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
1135357|NCT00473512|P3|Participant Flow|750 mg/Day|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
1135358|NCT00473512|P2|Participant Flow|500 mg/Day|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
1135359|NCT00473512|P1|Participant Flow|250 mg/Day|Abiraterone acetate 250 milligram (mg) capsule administered orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. Participants received MTD (1000 mg) of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
1135360|NCT00473512|O5|Outcome|Abiraterone Acetate 2000 mg|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135361|NCT00473512|O4|Outcome|Abiraterone Acetate 1000 mg|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135362|NCT00473512|O3|Outcome|Abiraterone Acetate 750 mg|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135363|NCT00473512|O2|Outcome|Abiraterone Acetate 500 mg|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1140892|NCT00460239|O3|Outcome|Morphine 30 mg|
1135364|NCT00473512|O1|Outcome|Abiraterone Acetate 250 mg|Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135365|NCT00473512|O5|Outcome|Abiraterone Acetate 2000 mg|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135366|NCT00473512|O4|Outcome|Abiraterone Acetate 1000 mg|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135367|NCT00473512|O3|Outcome|Abiraterone Acetate 750 mg|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135368|NCT00473512|O2|Outcome|Abiraterone Acetate 500 mg|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135369|NCT00473512|O1|Outcome|Abiraterone Acetate 250 mg|Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135370|NCT00473512|O5|Outcome|Abiraterone Acetate 2000 mg|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135371|NCT00473512|O4|Outcome|Abiraterone Acetate 1000 mg|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135372|NCT00473512|O3|Outcome|Abiraterone Acetate 750 mg|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135373|NCT00473512|O2|Outcome|Abiraterone Acetate 500 mg|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135374|NCT00473512|O1|Outcome|Abiraterone Acetate 250 mg|Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135375|NCT00473512|O5|Outcome|Abiraterone Acetate 2000 mg|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135376|NCT00473512|O4|Outcome|Abiraterone Acetate 1000 mg|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135377|NCT00473512|O3|Outcome|Abiraterone Acetate 750 mg|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135378|NCT00473512|O2|Outcome|Abiraterone Acetate 500 mg|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135379|NCT00473512|O1|Outcome|Abiraterone Acetate 250 mg|Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135380|NCT00473512|O5|Outcome|Abiraterone Acetate 2000 mg|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135381|NCT00473512|O4|Outcome|Abiraterone Acetate 1000 mg|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135382|NCT00473512|O3|Outcome|Abiraterone Acetate 750 mg|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135383|NCT00473512|O2|Outcome|Abiraterone Acetate 500 mg|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135384|NCT00473512|O1|Outcome|Abiraterone Acetate 250 mg|Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135385|NCT00473512|O5|Outcome|Abiraterone Acetate 2000 mg|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135386|NCT00473512|O4|Outcome|Abiraterone Acetate 1000 mg|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135387|NCT00473512|O3|Outcome|Abiraterone Acetate 750 mg|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135388|NCT00473512|O2|Outcome|Abiraterone Acetate 500 mg|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135389|NCT00473512|O1|Outcome|Abiraterone Acetate 250 mg|Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135390|NCT00473512|O5|Outcome|Abiraterone Acetate 2000 mg|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135391|NCT00473512|O4|Outcome|Abiraterone Acetate 1000 mg|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135392|NCT00473512|O3|Outcome|Abiraterone Acetate 750 mg|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135393|NCT00473512|O2|Outcome|Abiraterone Acetate 500 mg|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135394|NCT00473512|O1|Outcome|Abiraterone Acetate 250 mg|Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
1135395|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
1135396|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
1135397|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
1135398|NCT00473512|O5|Outcome|2000 mg/Day|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
1135399|NCT00473512|O4|Outcome|1000 mg/Day|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
1135400|NCT00473512|O3|Outcome|750 mg/Day|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
1135401|NCT00473512|O2|Outcome|500 mg/Day|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
1135402|NCT00473512|O1|Outcome|250 mg/Day|Abiraterone acetate 250 mg capsule administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
1135403|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
1135404|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
1135405|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
1135406|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
1135407|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
1135408|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
1135409|NCT00473512|O2|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
1135410|NCT00473512|O1|Outcome|1000 mg AA Monotherapy|Participants received 1000 milligram (mg) abiraterone acetate (AA) without dexamethasone.
1135411|NCT00473512|E5|Reported Event|2000 mg/Day|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
1135412|NCT00473512|E4|Reported Event|1000 mg/Day|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
1135413|NCT00473512|E3|Reported Event|750 mg/Day|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
1135414|NCT00473512|E2|Reported Event|500 mg/Day|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
1135473|NCT00473434|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135474|NCT00473434|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135415|NCT00473512|E1|Reported Event|250 mg/Day|Abiraterone acetate 250 mg capsule administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
1135416|NCT00473434|B1|Baseline|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135417|NCT00473434|P1|Participant Flow|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135418|NCT00473434|O9|Outcome|Week 52|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135419|NCT00473434|O8|Outcome|Week 44|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135420|NCT00473434|O7|Outcome|Week 20|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135421|NCT00473434|O6|Outcome|Week 12|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135422|NCT00473434|O5|Outcome|Week 9|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135423|NCT00473434|O4|Outcome|Week 6|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135424|NCT00473434|O3|Outcome|Week 4|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135425|NCT00473434|O2|Outcome|Week 2|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135426|NCT00473434|O1|Outcome|Baseline|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135427|NCT00473434|O11|Outcome|Week 52|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135428|NCT00473434|O10|Outcome|Week 44|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135429|NCT00473434|O9|Outcome|Week 36|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135430|NCT00473434|O8|Outcome|Week 28|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135431|NCT00473434|O7|Outcome|Week 20|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135432|NCT00473434|O6|Outcome|Week 12|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135433|NCT00473434|O5|Outcome|Week 9|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135434|NCT00473434|O4|Outcome|Week 6|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135435|NCT00473434|O3|Outcome|Week 4|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135436|NCT00473434|O2|Outcome|Week 2|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135437|NCT00473434|O1|Outcome|Baseline|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135438|NCT00473434|O11|Outcome|Week 52|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135439|NCT00473434|O10|Outcome|Week 44|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135440|NCT00473434|O9|Outcome|Week 36|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135441|NCT00473434|O8|Outcome|Week 28|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135442|NCT00473434|O7|Outcome|Week 20|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135443|NCT00473434|O6|Outcome|Week 12|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135444|NCT00473434|O5|Outcome|Week 9|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135445|NCT00473434|O4|Outcome|Week 6|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135446|NCT00473434|O3|Outcome|Week 4|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135447|NCT00473434|O2|Outcome|Week 2|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135448|NCT00473434|O1|Outcome|Baseline|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135449|NCT00473434|O11|Outcome|Week 52|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135450|NCT00473434|O10|Outcome|Week 44|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135451|NCT00473434|O9|Outcome|Week 36|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135452|NCT00473434|O8|Outcome|Week 28|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135453|NCT00473434|O7|Outcome|Week 20|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135454|NCT00473434|O6|Outcome|Week 12|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135455|NCT00473434|O5|Outcome|Week 9|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135456|NCT00473434|O4|Outcome|Week 6|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135457|NCT00473434|O3|Outcome|Week 4|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135458|NCT00473434|O2|Outcome|Week 2|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135459|NCT00473434|O1|Outcome|Baseline|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135460|NCT00473434|O11|Outcome|Week 52|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135461|NCT00473434|O10|Outcome|Week 44|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135462|NCT00473434|O9|Outcome|Week 36|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135463|NCT00473434|O8|Outcome|Week 28|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135464|NCT00473434|O7|Outcome|Week 20|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135465|NCT00473434|O6|Outcome|Week 12|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135466|NCT00473434|O5|Outcome|Week 9|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135467|NCT00473434|O4|Outcome|Week 6|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135468|NCT00473434|O3|Outcome|Week 4|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135469|NCT00473434|O2|Outcome|Week 2|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135470|NCT00473434|O1|Outcome|Baseline|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135471|NCT00473434|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135472|NCT00473434|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135475|NCT00473434|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135476|NCT00473434|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135477|NCT00473434|E1|Reported Event|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
1135478|NCT00473382|B4|Baseline|Total|Total of all reporting groups
1135479|NCT00473382|B3|Baseline|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months.
1135480|NCT00473382|B2|Baseline|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 24 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
1135481|NCT00473382|B1|Baseline|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 24 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
1135482|NCT00473382|P3|Participant Flow|Ranibizumab 0.5 mg|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
1136091|NCT00471107|B3|Baseline|Sham TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) sham stimulation during verbal memory tasks.
1135483|NCT00473382|P2|Participant Flow|Ranibizumab 0.3 mg|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
1135484|NCT00473382|P1|Participant Flow|Sham Injection/Ranibizumab 0.5 mg|Patients received a sham intravitreal injection monthly for 24 months. Patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
1135485|NCT00473382|O3|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135486|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135487|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135488|NCT00473382|O3|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135489|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135490|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135491|NCT00473382|O3|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135492|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135558|NCT00473330|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
1136336|NCT00469508|O1|Outcome|Modafinil|Modafinil 400mg oral dose taken daily for 12 weeks
1135493|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135494|NCT00473382|O3|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135495|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135531|NCT00473382|E7|Reported Event|Ranibizumab 0.5 mg - Months 37-60|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
1135496|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135497|NCT00473382|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
1135498|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
1135499|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
1135500|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
1135501|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months.
1135502|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 24 months.
1135503|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 24 months.
1135504|NCT00473382|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
1135505|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
1135506|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
1135507|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
1135508|NCT00473382|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135509|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
1135559|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months.
1135560|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months.
1135561|NCT00473330|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months.
1135510|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive Ranibizumab 0.5 mg as needed (pro re nata. PRN) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135511|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135512|NCT00473382|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
1135513|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
1135514|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
1135515|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
1135656|NCT00472797|O2|Outcome|Titrated|New formulation of rebif
1135516|NCT00473382|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135517|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
1135518|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135519|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135520|NCT00473382|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135521|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
1135522|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135523|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135562|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months.
1135524|NCT00473382|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135525|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
1135526|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135527|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135528|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months.
1135529|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 24 months.
1135530|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 24 months.
1135657|NCT00472797|O1|Outcome|Non-Titrated|New formulation of rebif
1136142|NCT00470626|O1|Outcome|Celect Vena Cava Filter|
1135532|NCT00473382|E6|Reported Event|Ranibizumab 0.3 mg - Months 37-60|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
1135533|NCT00473382|E5|Reported Event|Sham Injection/Ranibizumab 0.5 mg - Months 37-60|Patients received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
1135534|NCT00473382|E4|Reported Event|Ranibizumab 0.5 mg - Months 0-36|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months.
1135535|NCT00473382|E3|Reported Event|Ranibizumab 0.3 mg - Months 0-36|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months.
1135536|NCT00473382|E2|Reported Event|Sham Injection/Ranibizumab 0.5 mg - Months 0-36|Patients received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Data in this column represent the safety data in the sham group during the entire 36 months of the trial; most patients crossed over to receive ranibizumab 0.5 mg monthly in the third year.
1135537|NCT00473382|E1|Reported Event|Sham Injection - Months 0-24|Patients received a sham intravitreal injection monthly for 24 months. Data in this column represent the safety data in the sham group during the first 24 months of the trial when patients were receiving only sham injections. Safety data shown here are also included in the Sham/Ranibizumab 0.5 mg - Months 0-36 column.
1135538|NCT00473330|B4|Baseline|Total|Total of all reporting groups
1135539|NCT00473330|B3|Baseline|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months.
1135540|NCT00473330|B2|Baseline|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 24 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
1135541|NCT00473330|B1|Baseline|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 24 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
1135542|NCT00473330|P3|Participant Flow|Sham Injection/Ranibizumab 0.5 mg|Patients received a sham intravitreal injection monthly for 24 months. Patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
1135543|NCT00473330|P2|Participant Flow|Ranibizumab 0.5 mg|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
1135544|NCT00473330|P1|Participant Flow|Ranibizumab 0.3 mg|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
1136337|NCT00469508|O2|Outcome|Placebo|Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
1135545|NCT00473330|O3|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135546|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata. PRN) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135547|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135548|NCT00473330|O3|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135549|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata. PRN) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135658|NCT00472797|O3|Outcome|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
1135659|NCT00472797|O2|Outcome|Titrated|New formulation of rebif
1135550|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135551|NCT00473330|O3|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135552|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata. PRN) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135553|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135554|NCT00473330|O3|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135555|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135556|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135557|NCT00473330|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
1136338|NCT00469508|O1|Outcome|Modafinil|Modafinil 400mg oral dose taken daily for 12 weeks
1135563|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months.
1135564|NCT00473330|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
1135565|NCT00473330|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
1135566|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months.
1135567|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months.
1135568|NCT00473330|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135569|NCT00473330|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
1135660|NCT00472797|O1|Outcome|Non-Titrated|New formulation of rebif
1135570|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135571|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135572|NCT00473330|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
1135573|NCT00473330|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
1135574|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months.
1135575|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months.
1135576|NCT00473330|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135577|NCT00473330|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
1135578|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135579|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135580|NCT00473330|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135581|NCT00473330|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
1135582|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135583|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135661|NCT00472797|O3|Outcome|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
1135662|NCT00472797|O2|Outcome|Titrated|New formulation of rebif
1135663|NCT00472797|O1|Outcome|Non-Titrated|New formulation of rebif
1135664|NCT00472797|O3|Outcome|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
1135665|NCT00472797|O2|Outcome|Titrated|New formulation of rebif
1135666|NCT00472797|O1|Outcome|Non-Titrated|New formulation of rebif
1135584|NCT00473330|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135585|NCT00473330|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
1135586|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135587|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
1135588|NCT00473330|O3|Outcome|Sham Injection|Patients received a sham intravitreal injection monthly for 24 months.
1135589|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 24 months.
1135590|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 24 months.
1135591|NCT00473330|E7|Reported Event|Ranibizumab 0.5 mg - Months 37-60|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
1135592|NCT00473330|E6|Reported Event|Ranibizumab 0.3 mg - Months 37-60|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
1135593|NCT00473330|E5|Reported Event|Sham Injection/Ranibizumab 0.5 mg - Months 37-60|Patients received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
1135594|NCT00473330|E4|Reported Event|Ranibizumab 0.5 mg - Months 0-36|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months.
1135595|NCT00473330|E3|Reported Event|Ranibizumab 0.3 mg - Months 0-36|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months.
1135596|NCT00473330|E2|Reported Event|Sham Injection/Ranibizumab 0.5 mg - Months 0-36|Patients received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Data in this column represent the safety data in the sham group during the entire 36 months of the trial; most patients crossed over to receive ranibizumab 0.5 mg monthly in the third year.
1135705|NCT00472056|B3|Baseline|Cohort 1 65 Years of Age or Less With Arm 1|Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
1135597|NCT00473330|E1|Reported Event|Sham Injection - Months 0-24|Patients received a sham intravitreal injection monthly for 24 months. Data in this column represent the safety data in the sham group during the first 24 months of the trial when patients were receiving only sham injections. Safety data shown here are also included in the Sham/Ranibizumab 0.5 mg - Months 0-36 column.
1135598|NCT00473265|B1|Baseline|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
1135599|NCT00473265|P1|Participant Flow|PTH1-84|participants received PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
1135600|NCT00473265|O1|Outcome|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
1135601|NCT00473265|O1|Outcome|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
1135602|NCT00473265|O1|Outcome|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
1135603|NCT00473265|O1|Outcome|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
1135604|NCT00473265|O1|Outcome|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
1135605|NCT00473265|O1|Outcome|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
1135606|NCT00473265|E1|Reported Event|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
1135607|NCT00473083|B4|Baseline|Total|Total of all reporting groups
1135667|NCT00472797|O3|Outcome|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
1135668|NCT00472797|O2|Outcome|Titrated|New formulation of rebif
1135608|NCT00473083|B3|Baseline|Arm 3: No Treatment Unless Severe (Grade 3)|"Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution~clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
1135609|NCT00473083|B2|Baseline|Arm 2: Reactive Treatmen|"Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.~minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
1135610|NCT00473083|B1|Baseline|Arm 1: Prophylactic Treatment|"Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented~minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
1135611|NCT00473083|P3|Participant Flow|Arm 3: No Treatment Unless Severe (Grade 3)|"Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution~clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
1135612|NCT00473083|P2|Participant Flow|Arm 2: Reactive Treatment|"Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.~minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
1135613|NCT00473083|P1|Participant Flow|Arm 1: Prophylactic Treatment|"Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented~minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
1135706|NCT00472056|B2|Baseline|Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 1|Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
1137883|NCT00467259|O1|Outcome|Placebo|Placebo patch
1135614|NCT00473083|O3|Outcome|Arm 3: No Treatment Unless Severe (Grade 3)|"Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution~clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
1135615|NCT00473083|O2|Outcome|Arm 2: Reactive Treatment|"Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.~minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
1135616|NCT00473083|O1|Outcome|Arm 1: Prophylactic Treatment|"Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented~minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
1135669|NCT00472797|O1|Outcome|Non-Titrated|New formulation of rebif
1135670|NCT00472797|O1|Outcome|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
1135617|NCT00473083|O3|Outcome|Arm 3: No Treatment Unless Severe (Grade 3)|"Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution~clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
1135618|NCT00473083|O2|Outcome|Arm 2: Reactive Treatment|"Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.~minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
1135619|NCT00473083|O1|Outcome|Arm 1: Prophylactic Treatment|"Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented~minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
1135620|NCT00473083|O3|Outcome|Arm 3: No Treatment Unless Severe (Grade 3)|"Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution~clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
1135621|NCT00473083|O2|Outcome|Arm 2: Reactive Treatment|"Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.~minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
1135622|NCT00473083|O1|Outcome|Arm 1: Prophylactic Treatment|"Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented~minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
1138303|NCT00465972|O1|Outcome|Placebo|1 sugar taken nightly at bedtime.
1135623|NCT00473083|O3|Outcome|Arm 3: No Treatment Unless Severe (Grade 3)|"Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution~clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
1135624|NCT00473083|O2|Outcome|Arm 2: Reactive Treatment|"Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.~minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
1135625|NCT00473083|O1|Outcome|Arm 1: Prophylactic Treatment|"Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented~minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
1135671|NCT00472797|E3|Reported Event|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
1135672|NCT00472797|E2|Reported Event|Titrated|New formulation of rebif
1135626|NCT00473083|O3|Outcome|Arm 3: No Treatment Unless Severe (Grade 3)|"Arm 3: Subjects that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution~clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
1135627|NCT00473083|O2|Outcome|Arm 2: Reactive Treatment|"Arm 2: Subjects will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.~minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
1135628|NCT00473083|O1|Outcome|Arm 1: Prophylactic Treatment|"Subjects will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented~minocycline: Arm 1: Subjects will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
1135629|NCT00473083|O3|Outcome|Arm 3: No Treatment Unless Severe (Grade 3)|"Arm 3: Subjects that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution~clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
1135630|NCT00473083|O2|Outcome|Arm 2: Reactive Treatment|"Arm 2: Subjects will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.~minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
1135631|NCT00473083|O1|Outcome|Arm 1: Prophylactic Treatment|"Subjects will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented~minocycline: Arm 1: Subjects will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
1135707|NCT00472056|B1|Baseline|Cohort 1 65 Years of Age or Less With Arm 2|Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
1136339|NCT00469508|O2|Outcome|Placebo|Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
1135632|NCT00473083|O3|Outcome|Arm 3: No Treatment Unless Severe (Grade 3)|"Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution~clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
1135633|NCT00473083|O2|Outcome|Arm 2: Reactive Treatment|"Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.~minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
1135634|NCT00473083|O1|Outcome|Arm 1: Prophylactic Treatment|"Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented~minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
1135673|NCT00472797|E1|Reported Event|Non-Titrated|New formulation of rebif
1135674|NCT00472732|B3|Baseline|Total|Total of all reporting groups
1135675|NCT00472732|B2|Baseline|Healthy Males or Females Without Known Medical or Metabolic di|Healthy males or females without known medical or metabolic disorder (control group)
1136143|NCT00470626|O1|Outcome|Celect Vena Cava Filter|
1136144|NCT00470626|O1|Outcome|Celect Vena Cava Filter|
1135635|NCT00473083|E3|Reported Event|Arm 3: Treat Only if Grade 3 Rash Occurs|"Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution~clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution."
1135636|NCT00473083|E2|Reported Event|Arm 2: Treat Only Upon Initiation of Rash|"Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.~minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution"
1135637|NCT00473083|E1|Reported Event|Arm 1: Rash Prevention|"Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented~minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks."
1135638|NCT00472849|B3|Baseline|Total|Total of all reporting groups
1135639|NCT00472849|B2|Baseline|OFAR MTD (Phase II)|Oxaliplatin 25 mg/m^2 IV per day MTD on days 1-4 before Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-4. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after fludarabine dose started, on days 2-4. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses). Pegfilgrastim 6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy.
1135640|NCT00472849|B1|Baseline|OFAR (Phase I)|Oxaliplatin 30 mg/m^2/day over 2 hours before on days 1-4 Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-3, 2-4, or 2-5 until maximum tolerated dose reached. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after first fludarabine dose started, on days 2-3, 2-4, or 2-5, until maximum tolerated dose reached. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses).
1135641|NCT00472849|P2|Participant Flow|OFAR (Phase II)|Oxaliplatin 25 mg/m^2 IV per day (Phase I MTD) on days 1-4 before Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-4. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after fludarabine dose started, on days 2-4. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses). Pegfilgrastim 6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy.
1135642|NCT00472849|P1|Participant Flow|OFAR (Phase I)|Oxaliplatin starting dose 30 mg/m^2/day over 2 hours on days 1-4 before Fludarabine. Fludarabine 30 mg/m^2 daily intravenous (IV) over 30 minutes on days 2-3, 2-4, or 2-5 until maximum tolerated dose reached. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after first fludarabine dose started, on days 2-3, 2-4, or 2-5, until maximum tolerated dose reached. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses). Pegfilgrastim 6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy.
1135643|NCT00472849|O1|Outcome|OFAR (Phase I)|Oxaliplatin 30 mg/m^2/day over 2 hours before on days 1-4 Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-3, 2-4, or 2-5 until maximum tolerated dose reached. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after first fludarabine dose started, on days 2-3, 2-4, or 2-5, until maximum tolerated dose reached. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses).
1135644|NCT00472849|O1|Outcome|OFAR MTD (Phase II)|Oxaliplatin 25 mg/m^2 IV per day MTD on days 1-4 before Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-4. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after fludarabine dose started, on days 2-4. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses). Pegfilgrastim 6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy.
1135645|NCT00472849|E2|Reported Event|OFAR MTD (Phase II)|Oxaliplatin 25 mg/m^2 IV per day MTD on days 1-4 before Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-4. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after fludarabine dose started, on days 2-4. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses). Pegfilgrastim 6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy.
1135646|NCT00472849|E1|Reported Event|OFAR (Phase I)|Oxaliplatin 30 mg/m^2/day over 2 hours before on days 1-4 Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-3, 2-4, or 2-5 until maximum tolerated dose reached. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after first fludarabine dose started, on days 2-3, 2-4, or 2-5, until maximum tolerated dose reached. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses).
1135647|NCT00472797|B3|Baseline|Total|Total of all reporting groups
1135648|NCT00472797|B2|Baseline|New Formulation of Rebif - Titrated|
1135649|NCT00472797|B1|Baseline|New Formulation of Rebif - Non-Titrated|
1135650|NCT00472797|P2|Participant Flow|New Formulation of Rebif - Titrated|The new frmulation of rebif is not approved and under investigation in the US
1135651|NCT00472797|P1|Participant Flow|New Formulation of Rebif - Non-Titrated|The new formulation of rebif is not approved and under investigation in the US
1135652|NCT00472797|O3|Outcome|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
1135653|NCT00472797|O2|Outcome|Titrated|New formulation of rebif
1135654|NCT00472797|O1|Outcome|Non-Titrated|New formulation of rebif
1135655|NCT00472797|O3|Outcome|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
1135676|NCT00472732|B1|Baseline|Female Carriers of Ornithine Transcarbamylase Deficiency (OTCD|Female carriers of ornithine transcarbamylase deficiency (OTCD) or males with late onset presentation of OTCD
1135677|NCT00472732|P2|Participant Flow|Healthy Males or Females Without Known Medical or Metabolic di|Healthy males or females without known medical or metabolic disorder (control group)
1135678|NCT00472732|P1|Participant Flow|Female Carriers of Ornithine Transcarbamylase Deficiency (OTCD|Female carriers of ornithine transcarbamylase deficiency (OTCD) or males with late onset presentation of OTCD
1135679|NCT00472732|O2|Outcome|Healthy Controls|Healthy males or females without known medical or metabolic disorder (control group)
1135680|NCT00472732|O1|Outcome|OTCD Patients|Female carriers of ornithine transcarbamylase deficiency (OTCD) or males with late onset presentation of OTCD
1135681|NCT00472732|O2|Outcome|Healthy Controls|Healthy males or females without known medical or metabolic disorder (control group)
1135682|NCT00472732|O1|Outcome|OTCD Patients|Female carriers of ornithine transcarbamylase deficiency (OTCD) or males with late onset presentation of OTCD
1135683|NCT00472732|O2|Outcome|Healthy Controls|Healthy males or females without known medical or metabolic disorder (control group)
1135684|NCT00472732|O1|Outcome|OTCD Patients|Female carriers of ornithine transcarbamylase deficiency (OTCD) or males with late onset presentation of OTCD
1135685|NCT00472732|E2|Reported Event|Healthy Controls|Healthy males or females without known medical or metabolic disorder (control group)
1135686|NCT00472732|E1|Reported Event|OTCD Patients|Female carriers of ornithine transcarbamylase deficiency (OTCD) or males with late onset presentation of OTCD
1135687|NCT00472641|B1|Baseline|Ziprasidone/Geodon|"Ziprasidone/Geodon up to 320 mg per day~Ziprasidone/Geodon: Ziprasidone/Geodon"
1135688|NCT00472641|P1|Participant Flow|Ziprasidone/Geodon|"Ziprasidone/Geodon up to 320 mg per day~Ziprasidone/Geodon: Ziprasidone/Geodon"
1135689|NCT00472641|O1|Outcome|Ziprasidone/Geodon|"Ziprasidone/Geodon up to 320 mg per day~Ziprasidone/Geodon: Ziprasidone/Geodon"
1135690|NCT00472641|O1|Outcome|Ziprasidone/Geodon|"Ziprasidone/Geodon up to 320 mg per day~Ziprasidone/Geodon: Ziprasidone/Geodon"
1135691|NCT00472641|E1|Reported Event|Ziprasidone/Geodon|"Ziprasidone/Geodon up to 320 mg per day~Ziprasidone/Geodon: Ziprasidone/Geodon"
1135692|NCT00472576|B3|Baseline|Total|Total of all reporting groups
1135693|NCT00472576|B2|Baseline|MK-0657 Then Placebo|Patients receive 4-8 mg of MK-0657 for 12 days, have no treatment for 14 days, then receive placebo for 12 days.
1135694|NCT00472576|B1|Baseline|Placebo Then MK-0657|Patients receive placebo for 12 days, have no treatment for 14 days, then receive 4-8 mg of MK-0657 for 12 days.
1135695|NCT00472576|P2|Participant Flow|MK-0657 Then Placebo|Patients receive 4-8 mg of MK-0657 for 12 days, have no treatment for 14 days, then receive placebo for 12 days.
1135696|NCT00472576|P1|Participant Flow|Placebo Then MK-0657|Patients receive placebo for 12 days, have no treatment for 14 days, then receive 4-8 mg of MK-0657 for 12 days.
1135697|NCT00472576|O2|Outcome|MK-0657|Patients receive 4 to 8 mg of MK-0657 for 12 days.
1135698|NCT00472576|O1|Outcome|Placebo|Patients receive 4 to 8 mg of an inactive equivalent of MK-0657 for 12 days.
1135699|NCT00472576|O2|Outcome|MK-0657|Patients receive 4 to 8 mg of MK-0657 for 12 days.
1135700|NCT00472576|O1|Outcome|Placebo|Patients receive 4 to 8 mg of an inactive equivalent of MK-0657 for 12 days.
1135701|NCT00472576|E2|Reported Event|MK-0657|Patients receive 4 to 8 mg of MK-0657 for 12 days.
1135702|NCT00472576|E1|Reported Event|Placebo|Patients receive 4 to 8 mg of an inactive equivalent of MK-0657 for 12 days.
1135703|NCT00472056|B5|Baseline|Total|Total of all reporting groups
1135704|NCT00472056|B4|Baseline|Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 2|Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
1138550|NCT00465101|O1|Outcome|Peri-Operative (0-14 Days)|
1135708|NCT00472056|P4|Participant Flow|Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 2|Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
1135709|NCT00472056|P3|Participant Flow|Cohort 1 65 Years of Age or Less With Arm 1|Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
1135710|NCT00472056|P2|Participant Flow|Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 1|Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
1135711|NCT00472056|P1|Participant Flow|Cohort 1 65 Years of Age or Less With Arm 2|Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
1135712|NCT00472056|O2|Outcome|High Dose Rituximab|High dose arm: Rituximab 1000mg/m^2 intravenous on days +1 and +8 after stem cell infusion
1135713|NCT00472056|O1|Outcome|Standard Dose Rituximab|Standard dose arm: Rituximab 375 mg/m^2 intravenous on days +1 and +8 after stem cell infusion.
1135714|NCT00472056|E4|Reported Event|Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 2|Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
1135715|NCT00472056|E3|Reported Event|Cohort 1 65 Years of Age or Less With Arm 1|Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
1135716|NCT00472056|E2|Reported Event|Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 1|Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
1135717|NCT00472056|E1|Reported Event|Cohort 1 65 Years of Age or Less With Arm 2|Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
1135718|NCT00472030|B3|Baseline|Total|Total of all reporting groups
1135719|NCT00472030|B2|Baseline|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 mg/kg/day.
1135720|NCT00472030|B1|Baseline|Omalizumab Treatment Arm|Patients with bullous pemphigoid will be treated with omalizumab for a total treatment period of 16 weeks.
1136145|NCT00470626|E1|Reported Event|Celect Vena Cava Filter|
1135721|NCT00472030|P2|Participant Flow|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 milligrams per kilogram per day (mg/kg/day).
1135722|NCT00472030|P1|Participant Flow|Omalizumab Treatment Arm|Patients with bullous pemphigoid will be treated with omalizumab for a total treatment period of 14 weeks.
1135723|NCT00472030|O2|Outcome|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 milligrams per kilogram per day (mg/kg/day).
1135724|NCT00472030|O1|Outcome|Omalizumab Treatment Arm|Patients with bullous pemphigoid will be treated with omalizumab for a total treatment period of 14 weeks.
1135725|NCT00472030|O2|Outcome|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 milligrams per kilogram per day (mg/kg/day).
1135726|NCT00472030|O1|Outcome|Omalizumab Treatment Arm|Patients with bullous pemphigoid will be treated with omalizumab for a total treatment period of 14 weeks.
1135727|NCT00472030|O2|Outcome|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 mg/kg/day.
1135728|NCT00472030|O1|Outcome|Omalizumab Treatment Arm|Omalizumab 150-375 milligrams (mg) will be administered subcutaneously at Day 1, Week 2,4,6,8,10,12, and 14.
1135729|NCT00472030|O1|Outcome|Omalizumab Treatment Arm|Research subjects enrolled to the Omalizumab treatment arm will be treated with Omalizumab on Day 1 and at Week 2,4,6,8,10,12,& 14.
1135730|NCT00472030|O2|Outcome|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 milligrams per kilogram per day (mg/kg/day).
1135731|NCT00472030|O1|Outcome|Omalizumab Treatment Arm|Patients with bullous pemphigoid will be treated with Omalizumab on Day 1, Week 2,4,6,8,10,12 and 14.
1135732|NCT00472030|O2|Outcome|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 mg/kg/day.
1135733|NCT00472030|O1|Outcome|Omalizumab Treatment Arm|Omalizumab 150-375 milligrams (mg) will be administered subcutaneously at Day 1, Week 2,4,6,8,10,12, and 14.
1135734|NCT00472030|O1|Outcome|Omalizumab Treatment Arm|Omalizumab 150-375 milligrams (mg) will be administered subcutaneously at Day 1, Week 2,4,6,8,10,12, and 14.
1135735|NCT00472030|E2|Reported Event|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 mg/kg/day.
1135736|NCT00472030|E1|Reported Event|Omalizumab Treatment Arm|Patients with bullous pemphigoid will be treated with omalizumab for a total treatment period of 16 weeks.
1135737|NCT00472446|B5|Baseline|Total|Total of all reporting groups
1135738|NCT00472446|B4|Baseline|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135739|NCT00472446|B3|Baseline|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135740|NCT00472446|B2|Baseline|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135954|NCT00471705|P1|Participant Flow|Miltefosine|Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
1135741|NCT00472446|B1|Baseline|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135742|NCT00472446|P4|Participant Flow|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135743|NCT00472446|P3|Participant Flow|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135744|NCT00472446|P2|Participant Flow|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135781|NCT00472303|B2|Baseline|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
1135745|NCT00472446|P1|Participant Flow|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135746|NCT00472446|O4|Outcome|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135747|NCT00472446|O3|Outcome|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135748|NCT00472446|O2|Outcome|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135749|NCT00472446|O1|Outcome|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135750|NCT00472446|O4|Outcome|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135751|NCT00472446|O3|Outcome|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135752|NCT00472446|O2|Outcome|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135819|NCT00472303|O5|Outcome|Morphine Controlled Release Maintenance Phase|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
1135753|NCT00472446|O1|Outcome|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135754|NCT00472446|O4|Outcome|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135755|NCT00472446|O3|Outcome|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135756|NCT00472446|O2|Outcome|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135757|NCT00472446|O1|Outcome|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135758|NCT00472446|O4|Outcome|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135759|NCT00472446|O3|Outcome|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135760|NCT00472446|O2|Outcome|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135761|NCT00472446|O1|Outcome|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135762|NCT00472446|O4|Outcome|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135763|NCT00472446|O3|Outcome|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135764|NCT00472446|O2|Outcome|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135765|NCT00472446|O1|Outcome|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1138551|NCT00465101|O8|Outcome|5 Years|
1135766|NCT00472446|O4|Outcome|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135767|NCT00472446|O3|Outcome|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135768|NCT00472446|O2|Outcome|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135769|NCT00472446|O1|Outcome|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135770|NCT00472446|E4|Reported Event|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135771|NCT00472446|E3|Reported Event|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135772|NCT00472446|E2|Reported Event|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135773|NCT00472446|E1|Reported Event|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
1135774|NCT00472420|B1|Baseline|Rituximab + Chemotherapy|"Participants received rituximab, 375 mg/m^2, IV, on Day 1 of Cycles 1-8 (21-day cycle). Participants also received 1 of the following chemotherapies:~CHOP, Cycles 1-8: cyclophosphamide, 750 mg/m^2, IV, doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, vincristine, 1.4 mg/m^2, IV, on Day 1 of Cycles 1-8, and methylprednisolone, 16 mg/d, IV or PO, on Days 1-5.~OR Hyper-CVAD/M-A, Cycles 1, 3, 5, and 7: cyclophosphamide, 300 mg/m^2, IV, q12h on Days 2-4; mesna, 600 mg/m^2, IV, 1 hour before the start of cyclophosphamide on Days 2-4; doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, on Day 5; vincristine, 1.4 mg/m^2, IV, on Days 5 and 12; and dexamethasone, IV or PO, 40 mg/day on Days 2-5 and Days 12-15.~Hyper-CVAD/M-A, Cycles 2, 4, 6, and 8: methotrexate, 200 mg/m^2, IV, followed by 800 mg/m^2, IV, on Day 2; cytarabine, 3000 mg/m^2, IV over 2 hours, q12h on Day 3 (2 doses) or Days 3-4 (4 doses)."
1135775|NCT00472420|P1|Participant Flow|Rituximab Plus (+) Chemotherapy|"Participants received rituximab, 375 milligrams per square meter (mg/m^2), intravenously (IV), on Day 1 of Cycles 1-8 (21-day cycle). Participants also received 1 of the following chemotherapies:~CHOP, Cycles 1-8: cyclophosphamide, 750 mg/m^2, IV, doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, vincristine, 1.4 mg/m^2, IV, on Day 1 of Cycles 1-8, and methylprednisolone, 16 mg/d, IV or orally (PO), on Days 1-5.~OR Hyper-CVAD/M-A, Cycles 1, 3, 5, and 7: cyclophosphamide, 300 mg/m^2, IV, every 12 hours (q12h) on Days 2-4; mesna, 600 mg/m^2, IV, 1 hour before the start of cyclophosphamide on Days 2-4; doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, on Day 5; vincristine, 1.4 mg/m^2, IV, on Days 5 and 12; and dexamethasone, IV or PO, 40 mg/day on Days 2-5 and Days 12-15.~Hyper-CVAD/M-A, Cycles 2, 4, 6, and 8: methotrexate, 200 mg/m^2, IV, followed by 800 mg/m^2, IV, on Day 2; cytarabine, 3000 mg/m^2, IV over 2 hours, q12h on Day 3 (2 doses) or Days 3-4 (4 doses)."
1135776|NCT00472420|O1|Outcome|Rituximab + Chemotherapy|"Participants received rituximab, 375 mg/m^2, IV, on Day 1 of Cycles 1-8 (21-day cycle). Participants also received 1 of the following chemotherapies:~CHOP, Cycles 1-8: cyclophosphamide, 750 mg/m^2, IV, doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, vincristine, 1.4 mg/m^2, IV, on Day 1 of Cycles 1-8, and methylprednisolone, 16 mg/d, IV or PO, on Days 1-5.~OR Hyper-CVAD/M-A, Cycles 1, 3, 5, and 7: cyclophosphamide, 300 mg/m^2, IV, q12h on Days 2-4; mesna, 600 mg/m^2, IV, 1 hour before the start of cyclophosphamide on Days 2-4; doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, on Day 5; vincristine, 1.4 mg/m^2, IV, on Days 5 and 12; and dexamethasone, IV or PO, 40 mg/day on Days 2-5 and Days 12-15.~Hyper-CVAD/M-A, Cycles 2, 4, 6, and 8: methotrexate, 200 mg/m^2, IV, followed by 800 mg/m^2, IV, on Day 2; cytarabine, 3000 mg/m^2, IV over 2 hours, q12h on Day 3 (2 doses) or Days 3-4 (4 doses)."
1135777|NCT00472420|O1|Outcome|Rituximab + Chemotherapy|"Participants received rituximab, 375 mg/m^2, IV, on Day 1 of Cycles 1-8 (21-day cycle). Participants also received 1 of the following chemotherapies:~CHOP, Cycles 1-8: cyclophosphamide, 750 mg/m^2, IV, doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, vincristine, 1.4 mg/m^2, IV, on Day 1 of Cycles 1-8, and methylprednisolone, 16 mg/d, IV or PO, on Days 1-5.~OR Hyper-CVAD/M-A, Cycles 1, 3, 5, and 7: cyclophosphamide, 300 mg/m^2, IV, q12h on Days 2-4; mesna, 600 mg/m^2, IV, 1 hour before the start of cyclophosphamide on Days 2-4; doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, on Day 5; vincristine, 1.4 mg/m^2, IV, on Days 5 and 12; and dexamethasone, IV or PO, 40 mg/day on Days 2-5 and Days 12-15.~Hyper-CVAD/M-A, Cycles 2, 4, 6, and 8: methotrexate, 200 mg/m^2, IV, followed by 800 mg/m^2, IV, on Day 2; cytarabine, 3000 mg/m^2, IV over 2 hours, q12h on Day 3 (2 doses) or Days 3-4 (4 doses)."
1135778|NCT00472420|O1|Outcome|Rituximab + Chemotherapy|"Participants received rituximab, 375 mg/m^2, IV, on Day 1 of Cycles 1-8 (21-day cycle). Participants also received 1 of the following chemotherapies:~CHOP, Cycles 1-8: cyclophosphamide, 750 mg/m^2, IV, doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, vincristine, 1.4 mg/m^2, IV, on Day 1 of Cycles 1-8, and methylprednisolone, 16 mg/d, IV or PO, on Days 1-5.~OR Hyper-CVAD/M-A, Cycles 1, 3, 5, and 7: cyclophosphamide, 300 mg/m^2, IV, q12h on Days 2-4; mesna, 600 mg/m^2, IV, 1 hour before the start of cyclophosphamide on Days 2-4; doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, on Day 5; vincristine, 1.4 mg/m^2, IV, on Days 5 and 12; and dexamethasone, IV or PO, 40 mg/day on Days 2-5 and Days 12-15.~Hyper-CVAD/M-A, Cycles 2, 4, 6, and 8: methotrexate, 200 mg/m^2, IV, followed by 800 mg/m^2, IV, on Day 2; cytarabine, 3000 mg/m^2, IV over 2 hours, q12h on Day 3 (2 doses) or Days 3-4 (4 doses)."
1135779|NCT00472420|E1|Reported Event|Rituximab + Chemotherapy|"Participants received rituximab, 375 mg/m^2, IV, on Day 1 of Cycles 1-8 (21-day cycle). Participants also received 1 of the following chemotherapies:~CHOP, Cycles 1-8: cyclophosphamide, 750 mg/m^2, IV, doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, vincristine, 1.4 mg/m^2, IV, on Day 1 of Cycles 1-8, and methylprednisolone, 16 mg/d, IV or PO, on Days 1-5.~OR Hyper-CVAD/M-A, Cycles 1, 3, 5, and 7: cyclophosphamide, 300 mg/m^2, IV, q12h on Days 2-4; mesna, 600 mg/m^2, IV, 1 hour before the start of cyclophosphamide on Days 2-4; doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, on Day 5; vincristine, 1.4 mg/m^2, IV, on Days 5 and 12; and dexamethasone, IV or PO, 40 mg/day on Days 2-5 and Days 12-15.~Hyper-CVAD/M-A, Cycles 2, 4, 6, and 8: methotrexate, 200 mg/m^2, IV, followed by 800 mg/m^2, IV, on Day 2; cytarabine, 3000 mg/m^2, IV over 2 hours, q12h on Day 3 (2 doses) or Days 3-4 (4 doses)."
1135780|NCT00472303|B3|Baseline|Total|Total of all reporting groups
1135782|NCT00472303|B1|Baseline|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
1135783|NCT00472303|P3|Participant Flow|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo received 100 mg tapentadol prolonged release (PR) twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
1135784|NCT00472303|P2|Participant Flow|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
1135785|NCT00472303|P1|Participant Flow|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
1135786|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
1135787|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
1135788|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
1135789|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
1135790|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
1135791|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
1135792|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
1135793|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
1135794|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Followed by matching placebo in the maintenance (i.e. randomized withdrawal phase).
1135795|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
1135796|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
1136340|NCT00469508|O1|Outcome|Modafinil|Modafinil 400mg oral dose taken daily for 12 weeks
1135797|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
1135798|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase
1135799|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
1135800|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
1135801|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
1135802|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
1135803|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
1135804|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
1135829|NCT00472303|O3|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
1135805|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in the Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
1135806|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
1135807|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
1135808|NCT00472303|O2|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
1135809|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
1135810|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
1135811|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
1135812|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
1135813|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
1135814|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
1135815|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
1135816|NCT00472303|O1|Outcome|Tapentadol Extended Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
1135817|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
1135818|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
1135952|NCT00471705|P3|Participant Flow|Thermotherapy|One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
1135820|NCT00472303|O4|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily in the titration phase. Followed by matching placebo in the maintenance (i.e. randomized withdrawal phase).
1135821|NCT00472303|O3|Outcome|Tapentadol Prolonged Release (Maintenance Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
1135822|NCT00472303|O2|Outcome|Morphine Controlled Release Titration Phase|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses
1135823|NCT00472303|O1|Outcome|Tapentadol Prolonged Release (Titration Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
1135824|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
1135825|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
1135826|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
1135827|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
1135828|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
1136146|NCT00470600|B3|Baseline|Total|Total of all reporting groups
1136189|NCT00470535|O1|Outcome|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
1135830|NCT00472303|O2|Outcome|Matching Placebo After Tapentadol in the Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
1135831|NCT00472303|O1|Outcome|Tapentadol Prolonged Release (Maintenance Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
1135832|NCT00472303|O1|Outcome|Morphine Controlled Release (Titration Phase)|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
1135833|NCT00472303|O1|Outcome|Tapentadol Prolonged Release (Titration Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
1135834|NCT00472303|O3|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
1135835|NCT00472303|O2|Outcome|Matching Placebo After Tapentadol in the Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
1135836|NCT00472303|O1|Outcome|Tapentadol Prolonged Release (Maintenance Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
1135837|NCT00472303|O1|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
1135838|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
1135839|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
1135840|NCT00472303|O2|Outcome|Morphine Controlled Release (Maintenance Phase)|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
1135841|NCT00472303|O1|Outcome|Tapentadol Prolonged Release (Maintenance Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
1135842|NCT00472303|E5|Reported Event|Morphine Controlled Release (Maintenance Phase)|Oral Morphine 40 mg to 100 mg twice daily. The dose that was effective at the end of the Titration Phase.
1135843|NCT00472303|E4|Reported Event|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
1135844|NCT00472303|E3|Reported Event|Tapentadol Prolonged Release (Maintenance Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. The participant continued at the dose that was effective at the end of the Titration Phase.
1135845|NCT00472303|E2|Reported Event|Morphine Controlled Release (Titration Phase)|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
1135846|NCT00472303|E1|Reported Event|Tapentadol Prolonged Release (Titration Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
1135847|NCT00472290|B1|Baseline|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
1135848|NCT00472290|P1|Participant Flow|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
1135849|NCT00472290|O1|Outcome|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
1135850|NCT00472290|O1|Outcome|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
1135851|NCT00472290|O1|Outcome|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
1135852|NCT00472290|O1|Outcome|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
1135853|NCT00472290|O1|Outcome|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
1135854|NCT00472290|O1|Outcome|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
1135855|NCT00472290|O1|Outcome|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
1135856|NCT00472290|E1|Reported Event|Romiplostim|
1135857|NCT00472199|B3|Baseline|Total|Total of all reporting groups
1135858|NCT00472199|B2|Baseline|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135859|NCT00472199|B1|Baseline|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135860|NCT00472199|P2|Participant Flow|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135861|NCT00472199|P1|Participant Flow|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135862|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135863|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135864|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135865|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135866|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135867|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135868|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135953|NCT00471705|P2|Participant Flow|Glucantime®|Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
1138552|NCT00465101|O7|Outcome|4 Years|
1135869|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135870|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135871|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135872|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135873|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135874|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135875|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135876|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1136147|NCT00470600|B2|Baseline|800mg IV Ibuprofen (Caldolor)|8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
1135877|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135878|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135879|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135880|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135881|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135882|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135883|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135884|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135885|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135886|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135887|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135888|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135910|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1138553|NCT00465101|O6|Outcome|3 Years|
1135889|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135890|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135891|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135892|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135893|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135894|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135895|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135896|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135897|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1136148|NCT00470600|B1|Baseline|Placebo|250 mL of normal saline.
1135898|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135899|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135900|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135901|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135902|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135903|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135904|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135905|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135906|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135907|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135908|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135909|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135911|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135912|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135913|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135914|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135915|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135916|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135917|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135918|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1136089|NCT00471146|E1|Reported Event|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1135919|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135920|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135921|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135922|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135923|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135924|NCT00472199|E2|Reported Event|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135925|NCT00472199|E1|Reported Event|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
1135926|NCT00472082|B1|Baseline|Efalizumab Conversion|"The study drug Efalizumab will be given as part of a triple drug regimen including mycophenolate mofetil and prednisone. A test dose of Efalizumab 0.7mg/kg will be given at the enrollment visit. Beginning with study visit 2, Efalizumab 1mg/kg will be administered subcutaneously by injection on a weekly basis for 1 year. Mycophenolate mofetil will be given at a dose of 2gm/day which is the same as the standard of care dose. If patient experiences drug toxicity with mycophenolate mofetil they may be reduced and resume a minimum of at least 1gram daily to continue in the study. Patients will be maintained at 10mg of prednisone daily, same as standard of care.~efalizumab : Administration of a test dose of efalizumab 0.7mg/kg will be administered at enrollment. Weekly subcutaneous injections of efalizumab 1mg/kg will begin with study visit 2 and continue for 1 year for this pilot study."
1135927|NCT00472082|P1|Participant Flow|Efalizumab Conversion|"The study drug Efalizumab will be given as part of a triple drug regimen including mycophenolate mofetil and prednisone. A test dose of Efalizumab 0.7mg/kg will be given at the enrollment visit. Beginning with study visit 2, Efalizumab 1mg/kg will be administered subcutaneously by injection on a weekly basis for 1 year. Mycophenolate mofetil will be given at a dose of 2gm/day which is the same as the standard of care dose. If patient experiences drug toxicity with mycophenolate mofetil they may be reduced and resume a minimum of at least 1gram daily to continue in the study. Patients will be maintained at 10mg of prednisone daily, same as standard of care.~efalizumab : Administration of a test dose of efalizumab 0.7mg/kg will be administered at enrollment. Weekly subcutaneous injections of efalizumab 1mg/kg will begin with study visit 2 and continue for 1 year for this pilot study."
1136341|NCT00469508|E2|Reported Event|Placebo|Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
1135928|NCT00472082|O1|Outcome|Efalizumab Conversion|"The study drug Efalizumab will be given as part of a triple drug regimen including mycophenolate mofetil and prednisone. A test dose of Efalizumab 0.7mg/kg will be given at the enrollment visit. Beginning with study visit 2, Efalizumab 1mg/kg will be administered subcutaneously by injection on a weekly basis for 1 year. Mycophenolate mofetil will be given at a dose of 2gm/day which is the same as the standard of care dose. If patient experiences drug toxicity with mycophenolate mofetil they may be reduced and resume a minimum of at least 1gram daily to continue in the study. Patients will be maintained at 10mg of prednisone daily, same as standard of care.~efalizumab : Administration of a test dose of efalizumab 0.7mg/kg will be administered at enrollment. Weekly subcutaneous injections of efalizumab 1mg/kg will begin with study visit 2 and continue for 1 year for this pilot study."
1135929|NCT00472082|O1|Outcome|Efalizumab Conversion|"The study drug Efalizumab will be given as part of a triple drug regimen including mycophenolate mofetil and prednisone. A test dose of Efalizumab 0.7mg/kg will be given at the enrollment visit. Beginning with study visit 2, Efalizumab 1mg/kg will be administered subcutaneously by injection on a weekly basis for 1 year. Mycophenolate mofetil will be given at a dose of 2gm/day which is the same as the standard of care dose. If patient experiences drug toxicity with mycophenolate mofetil they may be reduced and resume a minimum of at least 1gram daily to continue in the study. Patients will be maintained at 10mg of prednisone daily, same as standard of care.~efalizumab : Administration of a test dose of efalizumab 0.7mg/kg will be administered at enrollment. Weekly subcutaneous injections of efalizumab 1mg/kg will begin with study visit 2 and continue for 1 year for this pilot study."
1135930|NCT00472082|E1|Reported Event|Efalizumab Conversion|"The study drug Efalizumab will be given as part of a triple drug regimen including mycophenolate mofetil and prednisone. A test dose of Efalizumab 0.7mg/kg will be given at the enrollment visit. Beginning with study visit 2, Efalizumab 1mg/kg will be administered subcutaneously by injection on a weekly basis for 1 year. Mycophenolate mofetil will be given at a dose of 2gm/day which is the same as the standard of care dose. If patient experiences drug toxicity with mycophenolate mofetil they may be reduced and resume a minimum of at least 1gram daily to continue in the study. Patients will be maintained at 10mg of prednisone daily, same as standard of care.~efalizumab : Administration of a test dose of efalizumab 0.7mg/kg will be administered at enrollment. Weekly subcutaneous injections of efalizumab 1mg/kg will begin with study visit 2 and continue for 1 year for this pilot study."
1135931|NCT00471822|B1|Baseline|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
1136090|NCT00471107|B4|Baseline|Total|Total of all reporting groups
1140893|NCT00460239|O2|Outcome|Morphine 15 mg|
1135932|NCT00471822|P1|Participant Flow|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
1135933|NCT00471822|O1|Outcome|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
1135934|NCT00471822|O1|Outcome|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
1135935|NCT00471822|O1|Outcome|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
1135936|NCT00471822|O1|Outcome|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
1135937|NCT00471822|O1|Outcome|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
1135938|NCT00471822|E1|Reported Event|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
1135939|NCT00471718|B1|Baseline|Phase I/II: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle
1135940|NCT00471718|P1|Participant Flow|Phase I/II: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle
1135941|NCT00471718|O1|Outcome|Phase I/11: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle
1135942|NCT00471718|O1|Outcome|Phase I/II: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle.
1135943|NCT00471718|O1|Outcome|Phase I/II: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle.
1135944|NCT00471718|O1|Outcome|Phase I/II: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle
1135945|NCT00471718|O1|Outcome|Phase I/11: ABT-751|Duration of overall response from time measurements are met for CR or PR until date that recurrence or PD is objectively documented
1135946|NCT00471718|O1|Outcome|ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle
1135947|NCT00471718|E1|Reported Event|Phase I/II: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle
1135948|NCT00471705|B4|Baseline|Total|Total of all reporting groups
1135949|NCT00471705|B3|Baseline|Thermotherapy|One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
1135950|NCT00471705|B2|Baseline|Glucantime®|Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
1135951|NCT00471705|B1|Baseline|Miltefosine|Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
1138554|NCT00465101|O5|Outcome|2 Years|
1135955|NCT00471705|O3|Outcome|Thermotherapy|One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
1135956|NCT00471705|O2|Outcome|Glucantime®|Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
1135957|NCT00471705|O1|Outcome|Miltefosine|Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
1135958|NCT00471705|O3|Outcome|Thermotherapy|One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
1135959|NCT00471705|O2|Outcome|Glucantime®|Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
1135960|NCT00471705|O1|Outcome|Miltefosine|Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
1135961|NCT00471705|O3|Outcome|Thermotherapy|One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
1135962|NCT00471705|O2|Outcome|Glucantime®|Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
1135963|NCT00471705|O1|Outcome|Miltefosine|Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
1135964|NCT00471705|E3|Reported Event|Thermotherapy|One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
1135965|NCT00471705|E2|Reported Event|Glucantime®|Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
1135966|NCT00471705|E1|Reported Event|Miltefosine|Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
1135967|NCT00471536|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1135968|NCT00471536|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1135969|NCT00471536|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1135970|NCT00471536|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1136190|NCT00470535|E1|Reported Event|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
1135971|NCT00471536|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1135972|NCT00471536|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1135973|NCT00471536|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1135974|NCT00471536|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1135975|NCT00471536|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1135976|NCT00471497|B4|Baseline|Total|Total of all reporting groups
1135977|NCT00471497|B3|Baseline|Nilotinib 400 mg BID|Patients who were randomized to this arm were to receive nilotinib 400 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
1135978|NCT00471497|B2|Baseline|Nilotinb 300 mg BID|Patients who were randomized to this arm were to receive nilotinib 300 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
1135979|NCT00471497|B1|Baseline|Imatinib 400 mg QD|Patients randomized to this arm were to receive 400 mg imatinib once a day (QD). If the patient required a dose escalation from 400 mg/day, the patient was to receive 400 mg imatinib twice daily orally. Imatinib was taken with food and a large glass of water. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits during the study. In cases of vomiting doses were not to be repeated.
1135980|NCT00471497|P3|Participant Flow|Nilotinib 400 mg BID|Patients who were randomized to this arm were to receive nilotinib 400 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
1136342|NCT00469508|E1|Reported Event|Modafinil|Modafinil 400mg oral dose taken daily for 12 weeks
1135981|NCT00471497|P2|Participant Flow|Nilotinb 300 mg BID|Patients who were randomized to this arm were to receive nilotinib 300 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
1135982|NCT00471497|P1|Participant Flow|Imatinib 400 mg QD|Patients randomized to this arm were to receive 400 mg imatinib once a day (QD). If the patient required a dose escalation from 400 mg/day, the patient was to receive 400 mg imatinib twice daily orally. Imatinib was taken with food and a large glass of water. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits during the study. In cases of vomiting doses were not to be repeated.
1135983|NCT00471497|O3|Outcome|Nilotinib 400mg BID|Patients who were randomized to this arm were to receive nilotinib 400 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
1136027|NCT00471328|O1|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression and cross-overed to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
1135984|NCT00471497|O2|Outcome|Nilotinb 300 mg BID|Patients who were randomized to this arm were to receive nilotinib 300 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
1135985|NCT00471497|O1|Outcome|Imatinib 400 mg QD|Patients randomized to this arm were to receive 400 mg imatinib once a day (QD). If the patient required a dose escalation from 400 mg/day, the patient was to receive 400 mg imatinib twice daily orally. Imatinib was taken with food and a large glass of water. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits during the study. In cases of vomiting doses were not to be repeated.
1135986|NCT00471497|E3|Reported Event|Nilotinib 400 mg BID|Patients who were randomized to this arm were to receive nilotinib 400 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
1135987|NCT00471497|E2|Reported Event|Nilotinib 300 mg BID|Patients who were randomized to this arm were to receive nilotinib 300 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
1135988|NCT00471497|E1|Reported Event|Imatinib 400 mg QD|Patients randomized to this arm were to receive 400 mg imatinib once a day (QD). If the patient required a dose escalation from 400 mg/day, the patient was to receive 400 mg imatinib twice daily orally. Imatinib was taken with food and a large glass of water. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits during the study. In cases of vomiting doses were not to be repeated.
1135989|NCT00471445|B3|Baseline|Total|Total of all reporting groups
1135990|NCT00471445|B2|Baseline|Placebo Cream|"Patients apply a placebo cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~placebo: Applied topically"
1135991|NCT00471445|B1|Baseline|Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr|"Patients apply amitriptyline and ketamine hydrochloride topical analgesic cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~ketamine/amitriptyline NP-H cream: Applied topically"
1135992|NCT00471445|P2|Participant Flow|Placebo Cream|"Patients apply a placebo cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~placebo: Applied topically"
1135993|NCT00471445|P1|Participant Flow|Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr|"Patients apply amitriptyline and ketamine hydrochloride topical analgesic cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~ketamine/amitriptyline NP-H cream: Applied topically"
1135994|NCT00471445|O2|Outcome|Placebo Cream|"Patients apply a placebo cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~placebo: Applied topically"
1135995|NCT00471445|O1|Outcome|Ketamine/Amitriptyline NP-H Cream|"Patients apply amitriptyline and ketamine hydrochloride topical analgesic cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~ketamine/amitriptyline NP-H cream: Applied topically"
1135996|NCT00471445|E2|Reported Event|Placebo Cream|"Patients apply a placebo cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~placebo: Applied topically"
1135997|NCT00471445|E1|Reported Event|Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr|"Patients apply amitriptyline and ketamine hydrochloride topical analgesic cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~ketamine/amitriptyline NP-H cream: Applied topically"
1135998|NCT00471380|B1|Baseline|Overall Study Population|
1135999|NCT00471380|P2|Participant Flow|Crossover Group BAA|Participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 1 (8 weeks). Then participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks).
1136000|NCT00471380|P1|Participant Flow|Crossover Group ABB|Participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for period 1 for 8 weeks. Then participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks)
1136057|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
1136001|NCT00471380|O2|Outcome|Crossover Group BAA|Participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 1 (8 weeks). Then participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks).
1136002|NCT00471380|O1|Outcome|Crossover Group ABB|Participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for period 1 for 8 weeks. Then participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks)
1136003|NCT00471380|E2|Reported Event|Treatment B|Participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.).
1136004|NCT00471380|E1|Reported Event|Treatment A|Participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.).
1136005|NCT00471354|B1|Baseline|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
1136006|NCT00471354|P1|Participant Flow|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
1136007|NCT00471354|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
1136008|NCT00471354|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
1136009|NCT00471354|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
1136010|NCT00471354|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
1136011|NCT00471354|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
1136012|NCT00471354|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
1136013|NCT00471354|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
1136014|NCT00471354|E1|Reported Event|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
1136015|NCT00471328|B3|Baseline|Total|Total of all reporting groups
1136016|NCT00471328|B2|Baseline|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
1136017|NCT00471328|B1|Baseline|Nilotinib|400 mg was taken orally twice daily in core and extension phase of the study
1136045|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
1136018|NCT00471328|P2|Participant Flow|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
1136019|NCT00471328|P1|Participant Flow|Nilotinib|400 mg was taken orally twice daily in core and extension phase of the study
1136020|NCT00471328|O1|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression and cross-overed to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
1136021|NCT00471328|O2|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
1136022|NCT00471328|O1|Outcome|Nilotinib|400 mg was taken orally twice daily in core and extension phase of the study
1136023|NCT00471328|O1|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression and cross-overed to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
1136024|NCT00471328|O2|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
1136025|NCT00471328|O1|Outcome|Nilotinib|400 mg was taken orally twice daily in core and extension phase of the study
1136026|NCT00471328|O1|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression and cross-overed to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
1136028|NCT00471328|O2|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
1136029|NCT00471328|O1|Outcome|Nilotinib|400 mg was taken orally twice daily in core and extension phase of the study
1136030|NCT00471328|O2|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
1136031|NCT00471328|O1|Outcome|Nilotinib|400 mg was taken orally twice daily in core and extension phase of the study
1136032|NCT00471328|O2|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
1136033|NCT00471328|O1|Outcome|Nilotinib|400 mg was taken orally twice daily in core and extension phase of the study
1136034|NCT00471328|E3|Reported Event|Crossover Nilotinib Therapy|All patients who crossed over from control arm to nilotinib after completing the Core study or during the Extension study after disease progression were included in safety assessment.
1136035|NCT00471328|E2|Reported Event|Control(Core + Extension)|Patients randomized to control arm, Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose before the study or at the dose of the investigator’s choice. The safety is assessed using these patient’s data from both core and extension phase of the study.
1136036|NCT00471328|E1|Reported Event|Nilotinib(Core +Extension)|Patients randomized to 400 mg Nilotinib which was taken orally twice daily. The safety is assessed using these patient’s data from both core and extension phase of the study.
1136037|NCT00471315|B1|Baseline|Duloxetine|Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
1136038|NCT00471315|P1|Participant Flow|Duloxetine|Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
1136039|NCT00471315|O1|Outcome|Duloxetine|Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
1136040|NCT00471315|O1|Outcome|Duloxetine|Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
1136041|NCT00471315|E1|Reported Event|Duloxetine|Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
1136042|NCT00471276|B1|Baseline|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
1136043|NCT00471276|P1|Participant Flow|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
1136044|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
1136117|NCT00470847|O1|Outcome|Lapatinib,Whole Brain Radiation,Herceptin|Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly
1136046|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
1136047|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
1136048|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
1136049|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
1136050|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
1136051|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
1136052|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
1136053|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
1136054|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
1136055|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
1136056|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
1136263|NCT00470158|E4|Reported Event|Zinc Alone|zinc, alternating daily with placebo
1136058|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
1136059|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
1136060|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
1136061|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
1136062|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
1136063|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
1136064|NCT00471276|E1|Reported Event|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
1136065|NCT00471146|B3|Baseline|Total|Total of all reporting groups
1136066|NCT00471146|B2|Baseline|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1136067|NCT00471146|B1|Baseline|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1136068|NCT00471146|P2|Participant Flow|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1136069|NCT00471146|P1|Participant Flow|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) in cycles of 4 weeks. Gemcitabine 1000 mg per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1136070|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1136071|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1136072|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1136073|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1136074|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1136075|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1136118|NCT00470847|O1|Outcome|Lapatinib,Whole Brain Radiation,Herceptin|Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly
1136076|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1136077|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1136078|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1136079|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1136080|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1136081|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1136082|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1136083|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1136084|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1136085|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1136086|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1136087|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1136088|NCT00471146|E2|Reported Event|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1136149|NCT00470600|P2|Participant Flow|800mg IV Ibuprofen (Caldolor)|8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
1136092|NCT00471107|B2|Baseline|Cathodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) cathodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
1136093|NCT00471107|B1|Baseline|Anodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) anodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
1136094|NCT00471107|P3|Participant Flow|Sham TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) sham stimulation during verbal memory tasks.
1136095|NCT00471107|P2|Participant Flow|Cathodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) cathodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
1136096|NCT00471107|P1|Participant Flow|Anodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) anodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
1136097|NCT00471107|O3|Outcome|Sham TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) sham stimulation during verbal memory tasks.
1136098|NCT00471107|O2|Outcome|Left Prefrontal Cathodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) cathodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
1136099|NCT00471107|O1|Outcome|Left Prefrontal Anodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) anodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
1136100|NCT00471107|E3|Reported Event|Sham TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) sham stimulation during verbal memory tasks.
1136101|NCT00471107|E2|Reported Event|Cathodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) cathodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
1136102|NCT00471107|E1|Reported Event|Anodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) anodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
1136103|NCT00471068|B3|Baseline|Total|Total of all reporting groups
1136104|NCT00471068|B2|Baseline|Cosopt|
1136105|NCT00471068|B1|Baseline|Travatan|
1136106|NCT00471068|P2|Participant Flow|Cosopt|
1136107|NCT00471068|P1|Participant Flow|Travatan|
1136108|NCT00471068|O2|Outcome|Cosopt|
1136109|NCT00471068|O1|Outcome|Travatan|
1136110|NCT00471068|E2|Reported Event|Cosopt|
1136111|NCT00471068|E1|Reported Event|Travatan|
1136112|NCT00470847|B1|Baseline|Lapatinib,Whole Brain Radiation,Herceptin|Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly
1136113|NCT00470847|P1|Participant Flow|Lapatinib,Whole Brain Radiation,Herceptin|Participants received lapatinib, orally, 750mg twice on day one followed by 1000mg, 1250mg, or 1500mg once daily. Whole Brain Radiation therapy (WBRT) (37.5 Gy, 15 fractions) began 1-8 days after starting lapatinib. Lapatinib was continued through WBRT. Following WBRT, patients received trastuzumab intravenously 2mg/kg weekly and lapatinib 1000mg orally once daily.
1136114|NCT00470847|O1|Outcome|Lapatinib,Whole Brain Radiation,Herceptin|Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly
1136115|NCT00470847|O1|Outcome|Lapatinib,Whole Brain Radiation,Herceptin|Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly
1136116|NCT00470847|O1|Outcome|Lapatinib,Whole Brain Radiation,Herceptin|Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly
1136119|NCT00470847|O1|Outcome|Lapatinib,Whole Brain Radiation,Herceptin|Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly
1136120|NCT00470847|E3|Reported Event|Dose Level 3|n=5 participants 1500 mg lapatinib daily
1136121|NCT00470847|E2|Reported Event|Dose Level 1|n=3 participants 1000 mg lapatinib daily
1136122|NCT00470847|E1|Reported Event|Dose Level 2|n=27 participants Maximum Tolerated Dose 1250 mg lapatinib daily
1136123|NCT00470834|B3|Baseline|Total|Total of all reporting groups
1136124|NCT00470834|B2|Baseline|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
1136125|NCT00470834|B1|Baseline|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
1136126|NCT00470834|P2|Participant Flow|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
1136150|NCT00470600|P1|Participant Flow|Placebo|250 mL of normal saline.
1136151|NCT00470600|O2|Outcome|800mg IV Ibuprofen (Caldolor)|8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
1136152|NCT00470600|O1|Outcome|Placebo|250 mL of normal saline.
1136153|NCT00470600|O2|Outcome|800mg IV Ibuprofen (Caldolor)|8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
1136127|NCT00470834|P1|Participant Flow|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
1136128|NCT00470834|O2|Outcome|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
1136129|NCT00470834|O1|Outcome|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
1136130|NCT00470834|O2|Outcome|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
1136131|NCT00470834|O1|Outcome|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
1136132|NCT00470834|O2|Outcome|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
1136133|NCT00470834|O1|Outcome|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
1136134|NCT00470834|O2|Outcome|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
1136226|NCT00470275|O1|Outcome|Cytarabine|Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
1136135|NCT00470834|O1|Outcome|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
1136136|NCT00470834|O2|Outcome|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
1136137|NCT00470834|O1|Outcome|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
1136138|NCT00470834|E2|Reported Event|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
1136139|NCT00470834|E1|Reported Event|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
1136140|NCT00470626|B1|Baseline|Celect Vena Cava Filter|
1136141|NCT00470626|P1|Participant Flow|Celect Vena Cava Filter|
1136155|NCT00470600|O2|Outcome|800mg IV Ibuprofen (Caldolor)|8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
1136156|NCT00470600|O1|Outcome|Placebo|250 mL of normal saline.
1136157|NCT00470600|E2|Reported Event|800mg IV Ibuprofen (Caldolor)|8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
1136158|NCT00470600|E1|Reported Event|Placebo|250 mL of normal saline.
1136159|NCT00470548|B3|Baseline|Total|Total of all reporting groups
1136160|NCT00470548|B2|Baseline|Phase II: Abraxane and Pemetrexed|Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 260 mg/m2IV administration following pemetrexed on Day 1 of each cycle
1136161|NCT00470548|B1|Baseline|Phase I: Abraxane and Pemetrexed|A 3 + 3 dose escalation design was used to determine the maximum tolerated dose and the recommended phase II dose. Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 180 mg/m2, 220 mg/m2 and 260 mg/m2 IV administration following pemetrexed on Day 1 of each cycle .
1136162|NCT00470548|P4|Participant Flow|Phase II|Pemetrexed 500 mg/m2 plus Abraxane 260 mg/m2
1136163|NCT00470548|P3|Participant Flow|Phase I: Dose Level 3|Pemetrexed 500 mg/m2 plus Abraxane 260 mg/m2
1136164|NCT00470548|P2|Participant Flow|Phase I: Dose Level 2|Pemetrexed 500 mg/m2 plus Abraxane 220 mg/m2
1136165|NCT00470548|P1|Participant Flow|Phase I: Dose Level 1|Pemetrexed 500 mg/m2 plus Abraxane 180 mg/m2
1136166|NCT00470548|O2|Outcome|Phase II: Abraxane and Pemetrexed|Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 260 mg/m2IV administration following pemetrexed on Day 1 of each cycle
1136167|NCT00470548|O1|Outcome|Phase I: Abraxane and Pemetrexed|A 3 + 3 dose escalation design was used to determine the maximum tolerated dose and the recommended phase II dose. Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 180 mg/m2, 220 mg/m2 and 260 mg/m2 IV administration following pemetrexed on Day 1 of each cycle .
1136168|NCT00470548|O2|Outcome|Phase II: Abraxane and Pemetrexed|Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 260 mg/m2IV administration following pemetrexed on Day 1 of each cycle
1136169|NCT00470548|O1|Outcome|Phase I: Abraxane and Pemetrexed|A 3 + 3 dose escalation design was used to determine the maximum tolerated dose and the recommended phase II dose. Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 180 mg/m2, 220 mg/m2 and 260 mg/m2 IV administration following pemetrexed on Day 1 of each cycle .
1136170|NCT00470548|O2|Outcome|Phase II: Abraxane and Pemetrexed|Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 260 mg/m2IV administration following pemetrexed on Day 1 of each cycle
1136171|NCT00470548|O1|Outcome|Phase I: Abraxane and Pemetrexed|A 3 + 3 dose escalation design was used to determine the maximum tolerated dose and the recommended phase II dose. Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 180 mg/m2, 220 mg/m2 and 260 mg/m2 IV administration following pemetrexed on Day 1 of each cycle .
1136172|NCT00470548|O2|Outcome|Phase II: Abraxane and Pemetrexed|Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 260 mg/m2IV administration following pemetrexed on Day 1 of each cycle
1136173|NCT00470548|O1|Outcome|Phase I: Abraxane and Pemetrexed|A 3 + 3 dose escalation design was used to determine the maximum tolerated dose and the recommended phase II dose. Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 180 mg/m2, 220 mg/m2 and 260 mg/m2 IV administration following pemetrexed on Day 1 of each cycle .
1136174|NCT00470548|O2|Outcome|Phase II: Abraxane and Pemetrexed|Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 260 mg/m2IV administration following pemetrexed on Day 1 of each cycle
1136343|NCT00469456|B3|Baseline|Total|Total of all reporting groups
1136175|NCT00470548|O1|Outcome|Phase I: Abraxane and Pemetrexed|A 3 + 3 dose escalation design was used to determine the maximum tolerated dose and the recommended phase II dose. Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 180 mg/m2, 220 mg/m2 and 260 mg/m2 IV administration following pemetrexed on Day 1 of each cycle .
1136176|NCT00470548|O1|Outcome|Phase II: Pemetrexed and Abraxane|Pemetrexed 500 mg/m2 plus Abraxane 260 mg/m2
1136177|NCT00470548|O3|Outcome|Phase I: Dose Level 3|A 3 + 3 dose escalation design was used to determine the maximum tolerated dose and the recommended phase II dose. Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 260 mg/m2 IV administration following pemetrexed on Day 1 of each cycle .
1136178|NCT00470548|O2|Outcome|Phase I: Dose Level 2|A 3 + 3 dose escalation design was used to determine the maximum tolerated dose and the recommended phase II dose. Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 220 mg/m2 IV administration following pemetrexed on Day 1 of each cycle .
1136179|NCT00470548|O1|Outcome|Phase I: Dose Level 1|A 3 + 3 dose escalation design was used to determine the maximum tolerated dose and the recommended phase II dose. Alimta® (pemetrexed) 500 mg/m2 IV administration on Day 1 of each cycle with Abraxane® (ABI 007) 180 mg/m2 IV administration following pemetrexed on Day 1 of each cycle .
1136180|NCT00470548|E2|Reported Event|Phase II: Abraxane and Alimta|"Pemetrexed 500mg/m2 day 1 and nab-paclitaxel day 1 at 260 mg/m2 every 21 days.~Abraxane: ABI-007 IV administration following pemetrexed on Day 1 of each cycle (infused over 30 minutes)~Alimta: Pemetrexed IV administration on Day 1 of each cycle (infused over 10 minutes)"
1136181|NCT00470548|E1|Reported Event|Phase I: Abraxane and Alimta|"Three dose levels were tested. Pemetrexed 500mg/m2 day 1 and nab-paclitaxel day 1 at 180, 220, and 260 mg/m2 every 21 days.~Abraxane: ABI-007 IV administration following pemetrexed on Day 1 of each cycle (infused over 30 minutes)~Alimta: Pemetrexed IV administration on Day 1 of each cycle (infused over 10 minutes)"
1136182|NCT00470535|B1|Baseline|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
1136183|NCT00470535|P1|Participant Flow|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
1136184|NCT00470535|O1|Outcome|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
1136185|NCT00470535|O1|Outcome|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
1136186|NCT00470535|O1|Outcome|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
1136187|NCT00470535|O1|Outcome|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
1136188|NCT00470535|O1|Outcome|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
1136191|NCT00470470|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral imatinib mesylate 400 mg twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
1136192|NCT00470470|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral imatinib mesylate 400 mg twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
1136193|NCT00470470|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral imatinib mesylate 400 mg twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
1136194|NCT00470470|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral imatinib mesylate 400 mg twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
1136195|NCT00470470|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral imatinib mesylate 400 mg twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
1136196|NCT00470418|B3|Baseline|Total|Total of all reporting groups
1136197|NCT00470418|B2|Baseline|Placebo|"Subjects with Alzheimer's Disease~Placebo: placebo comparator"
1136198|NCT00470418|B1|Baseline|NIC5-15|"Subjects with Alzheimer's Disease~NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects"
1136199|NCT00470418|P2|Participant Flow|Placebo|"Placebo: placebo comparator identical in pill size, appearance and number~Subjects with Alzheimer's Disease"
1136200|NCT00470418|P1|Participant Flow|NIC5-15|"NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects. Subjects received escalating doses of 1500, 3000 and 5000 mg daily over the course of the study.~Subjects with Alzheimer's Disease"
1136201|NCT00470418|O2|Outcome|Placebo|"Subjects with Alzheimer's Disease~Placebo: placebo comparator"
1136202|NCT00470418|O1|Outcome|NIC5-15|"Subjects with Alzheimer's Disease~NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects"
1136203|NCT00470418|O2|Outcome|Placebo|"Subjects with Alzheimer's Disease~Placebo: placebo comparator"
1136204|NCT00470418|O1|Outcome|NIC5-15|"Subjects with Alzheimer's Disease~NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects"
1136205|NCT00470418|E2|Reported Event|Placebo|"Subjects with Alzheimer's Disease~Placebo: placebo comparator"
1136206|NCT00470418|E1|Reported Event|NIC5-15|"Subjects with Alzheimer's Disease~NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects"
1136207|NCT00470392|B3|Baseline|Total|Total of all reporting groups
1136208|NCT00470392|B2|Baseline|Clobetasol|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
1136209|NCT00470392|B1|Baseline|Imiquimod|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
1138555|NCT00465101|O4|Outcome|1 Year|
1136210|NCT00470392|P2|Participant Flow|Clobetasol|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
1136211|NCT00470392|P1|Participant Flow|Imiquimod|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
1136212|NCT00470392|O2|Outcome|Clobetasol|"Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.~No synchronized T cell reactivation was observed upon immunohistochemical analysis, nor upon analysis of T cell death associated gene (TDAG) mRNA by PCR, with Clobetasol treatment, so this arm was terminated."
1136213|NCT00470392|O1|Outcome|Imiquimod|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
1136214|NCT00470392|O2|Outcome|Clobetasol|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point. No synchronized T cell reactivation was observed upon immunohistochemical analysis, nor upon analysis of T cell death associated gene (TDAG) mRNA by PCR, with Clobetasol treatment, so this arm was terminated.
1136264|NCT00470158|E3|Reported Event|Iron Alone|iron, alternating daily with placebo
1136265|NCT00470158|E2|Reported Event|Separate Iron and Zinc|iron, alternating daily with zinc
1136215|NCT00470392|O1|Outcome|Imiquimod|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
1136216|NCT00470392|O2|Outcome|Clobetasol|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point. No synchronized T cell reactivation was observed upon immunohistochemical analysis, nor upon analysis of T cell death associated gene (TDAG) mRNA by PCR, with Clobetasol treatment, so this arm was terminated.
1136217|NCT00470392|O1|Outcome|Imiquimod|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
1136218|NCT00470392|E2|Reported Event|Clobetasol|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
1136219|NCT00470392|E1|Reported Event|Imiquimod|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
1136220|NCT00470301|B1|Baseline|Arm I|"See Detailed Description~tipifarnib: Given orally~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~pegfilgrastim: Given SC~conventional surgery: surgical procedures performed on patients~axillary lymph node dissection: correlative study"
1136221|NCT00470301|P1|Participant Flow|Arm I|"See Detailed Description~tipifarnib: Given orally~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~pegfilgrastim: Given SC~conventional surgery: surgical procedures performed on patients~axillary lymph node dissection: correlative study"
1136222|NCT00470301|O1|Outcome|Arm I|"See Detailed Description~tipifarnib: Given orally~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~pegfilgrastim: Given SC~conventional surgery: surgical procedures performed on patients~axillary lymph node dissection: correlative study"
1136223|NCT00470301|E1|Reported Event|Arm I|"See Detailed Description~tipifarnib: Given orally~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~pegfilgrastim: Given SC~conventional surgery: surgical procedures performed on patients~axillary lymph node dissection: correlative study"
1136224|NCT00470275|B1|Baseline|Cytarbine|Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
1136225|NCT00470275|P1|Participant Flow|Cytarbine|Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
1138556|NCT00465101|O3|Outcome|6 Months|
1136227|NCT00470275|E1|Reported Event|Cytarabine|Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
1136228|NCT00470262|B3|Baseline|Total|Total of all reporting groups
1136229|NCT00470262|B2|Baseline|Fenofibrate 145 mg PO QD and Pioglitazone 45mg PO QD|Treatment with Fenofibrate 145 mg PO QD and Pioglitazone 45mg PO QD in subjects with pre diabetes
1136230|NCT00470262|B1|Baseline|Fenofibrate 145 mg PO QD|Treatment fenofibrate 145 mg PO QD in subjects with pre diabetes
1136231|NCT00470262|P2|Participant Flow|Piolitazone 45 mg PO QD + Fenofibrate 145mg PO QD|Pioglitazone and Fenofibrate: Subjects will be randomized to a combination of both fenofibrate(145mg PO QD) and pioglitazone 45 mg PO QD
1136232|NCT00470262|P1|Participant Flow|Fenofibrate|Treatment with fenofibrate 145mg PO QD
1136233|NCT00470262|O2|Outcome|Fenofibrate 145mg PO QD + Pioglitazone 45mg PO BID|Treatment with pioglitazone and fenofibrate in subjects with pre diabetes
1136234|NCT00470262|O1|Outcome|Fenofibrate 145mg PO QD|Treatment with fenofibrate in subjects with pre diabetes
1136235|NCT00470262|O2|Outcome|Fenofibrate 145 mg PO QD + Pioglitazone|Treatment with fenofibrate and pioglitazone in subjects with pre diabetes
1136236|NCT00470262|O1|Outcome|Fenofibrate 145mg PO QD|Treatment with fenofibrate in subjects with pre diabetes
1136237|NCT00470262|E2|Reported Event|Fenofibrate 145 mg PO QD and Pioglitazone 45 mg PO QD|Treatment with fenofibrate 145 mg PO QD and Pioglitazone 45 mg PO QD in subjects with pre diabetes
1136238|NCT00470262|E1|Reported Event|Fenofibrate 145mg PO QD|Treatment with fenofibrate 145 mg PO QD in subjects with pre diabetes
1136239|NCT00470184|B1|Baseline|COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy|"Cycle 1:~Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3."
1136266|NCT00470158|E1|Reported Event|Combined Iron and Zinc|combined iron and zinc, alternating daily with placebo
1136267|NCT00470106|B5|Baseline|Total|Total of all reporting groups
1136240|NCT00470184|P1|Participant Flow|COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy|"Cycle 1:~Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3."
1136241|NCT00470184|O1|Outcome|COR (Capecitabine in Combination w/Oxaliplatin & Radiotherapy|"Cycle 1:~Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3."
1136242|NCT00470184|O1|Outcome|COR (Capecitabine in Combination w/Oxaliplatin & Radiotherapy|"Cycle 1:~Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3."
1136243|NCT00470184|O1|Outcome|COR (Capecitabine in Combination w/Oxaliplatin & Radiotherapy|"Cycle 1:~Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3."
1136289|NCT00470067|P1|Participant Flow|Doxorubicin and Carboplatin|"Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1~carboplatin: IV~pegylated liposomal doxorubicin hydrochloride: IV"
1136290|NCT00470067|O1|Outcome|Doxorubicin and Carboplatin|"Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1~carboplatin: IV~pegylated liposomal doxorubicin hydrochloride: IV"
1136344|NCT00469456|B2|Baseline|Memantine|Memantine 20mg (10mg twice daily), oral administration for 12 weeks
1136244|NCT00470184|O1|Outcome|COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy|"Cycle 1:~Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3."
1136245|NCT00470184|E1|Reported Event|COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy|"Cycle 1:~Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3."
1136246|NCT00470158|B6|Baseline|Total|Total of all reporting groups
1136247|NCT00470158|B5|Baseline|Placebo|placebo daily
1136248|NCT00470158|B4|Baseline|Zinc Alone|zinc, alternating daily with placebo
1136249|NCT00470158|B3|Baseline|Iron Alone|iron, alternating daily with placebo
1136250|NCT00470158|B2|Baseline|Separate Iron and Zinc|iron, alternating daily with zinc
1136251|NCT00470158|B1|Baseline|Combined Iron and Zinc|combined iron and zinc, alternating daily with placebo
1136252|NCT00470158|P5|Participant Flow|Placebo|placebo daily
1136253|NCT00470158|P4|Participant Flow|Zinc Alone|zinc, alternating daily with placebo
1136254|NCT00470158|P3|Participant Flow|Iron Alone|iron, alternating daily with placebo
1136255|NCT00470158|P2|Participant Flow|Separate Iron and Zinc|iron, alternating daily with zinc
1136256|NCT00470158|P1|Participant Flow|Combined Iron and Zinc|combined iron and zinc, alternating daily with placebo
1136257|NCT00470158|O5|Outcome|Placebo|placebo daily
1136258|NCT00470158|O4|Outcome|Zinc Alone|zinc, alternating daily with placebo
1136259|NCT00470158|O3|Outcome|Iron Alone|iron, alternating daily with placebo
1136260|NCT00470158|O2|Outcome|Separate Iron and Zinc|iron, alternating daily with zinc
1136261|NCT00470158|O1|Outcome|Combined Iron and Zinc|combined iron and zinc, alternating daily with placebo
1136262|NCT00470158|E5|Reported Event|Placebo|placebo daily
1136268|NCT00470106|B4|Baseline|Control - Social Skills Training|This group was a control for the amount of time in sessions. There was no social cognitive training.
1136269|NCT00470106|B3|Baseline|Hybrid Group|Half of the sessions were cognitive remediation and half were social cognitive training.
1136270|NCT00470106|B2|Baseline|Cognitive Remediation|Cognitive remediation: Computer exercises in attention, memory, and speed of processing.
1136271|NCT00470106|B1|Baseline|Social Cognition|Social Cognitive remediation: Group training on emotion perception, social perception, and understanding others' mental states.
1136272|NCT00470106|P4|Participant Flow|Control - Social Skills Training|This group was a control for the amount of time in sessions. There was no social cognitive training.
1136273|NCT00470106|P3|Participant Flow|Hybrid Group|Half of the sessions were cognitive remediation and half were social cognitive training.
1136274|NCT00470106|P2|Participant Flow|Cognitive Remediation|Cognitive remediation: Computer exercises in attention, memory, and speed of processing.
1136275|NCT00470106|P1|Participant Flow|Social Cognition|Social Cognitive remediation: Group training on emotion perception, social perception, and understanding others' mental states.
1136276|NCT00470106|O4|Outcome|Control - Social Skills Training|This group was a control for the amount of time in sessions. There was no social cognitive training.
1136277|NCT00470106|O3|Outcome|Hybrid Group|Half of the sessions were cognitive remediation and half were social cognitive training.
1136278|NCT00470106|O2|Outcome|Cognitive Remediation|Cognitive remediation: Computer exercises in attention, memory, and speed of processing.
1136279|NCT00470106|O1|Outcome|Social Cognition|Social Cognitive remediation: Group training on emotion perception, social perception, and understanding others' mental states.
1136280|NCT00470106|O4|Outcome|Skills Training|"control training~skills training: Skills training in how to identify symptoms of illness and medication side effects."
1136281|NCT00470106|O3|Outcome|Hybrid Intervention|"combined social cognitive and cognitive remediation training~hybrid intervention: A combination of the two groups listed above."
1136282|NCT00470106|O2|Outcome|Cognitive Remediation|"cognitive remediation~Cognitive remediation: Computer exercises in attention, memory, and speed of processing."
1136283|NCT00470106|O1|Outcome|Social Cognitive Skills Training|"social cognitive skills training~Social Cognitive skills training: Group training on emotion perception, social perception, and understanding others' mental states."
1136284|NCT00470106|E4|Reported Event|Control - Social Skills Training|This group was a control for the amount of time in sessions. There was no social cognitive training.
1136285|NCT00470106|E3|Reported Event|Hybrid Group|Half of the sessions were cognitive remediation and half were social cognitive training.
1136286|NCT00470106|E2|Reported Event|Cognitive Remediation|Cognitive remediation: Computer exercises in attention, memory, and speed of processing.
1136287|NCT00470106|E1|Reported Event|Social Cognition|Social Cognitive remediation: Group training on emotion perception, social perception, and understanding others' mental states.
1136288|NCT00470067|B1|Baseline|Doxorubicin and Carboplatin|"Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1~carboplatin: IV~pegylated liposomal doxorubicin hydrochloride: IV"
1136291|NCT00470067|E1|Reported Event|Doxorubicin and Carboplatin|"Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1~carboplatin: IV~pegylated liposomal doxorubicin hydrochloride: IV"
1136292|NCT00470054|B1|Baseline|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
1136293|NCT00470054|P1|Participant Flow|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
1136294|NCT00470054|O1|Outcome|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
1136295|NCT00470054|O1|Outcome|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
1136296|NCT00470054|O1|Outcome|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
1136297|NCT00470054|O1|Outcome|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
1136298|NCT00470054|O1|Outcome|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
1136299|NCT00470054|E1|Reported Event|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
1136300|NCT00469898|B1|Baseline|Therapeutic Intervention|
1136301|NCT00469898|P1|Participant Flow|Therapeutic Intervention|
1136302|NCT00469898|O1|Outcome|Therapeutic Intervention|
1136303|NCT00469898|O1|Outcome|Therapeutic Intervention|
1136304|NCT00469898|O1|Outcome|Therapeutic Intervention|
1136305|NCT00469898|O1|Outcome|Therapeutic Intervention|
1136306|NCT00469898|E1|Reported Event|Therapeutic Intervention|
1136307|NCT00469859|B3|Baseline|Total|Total of all reporting groups
1136308|NCT00469859|B2|Baseline|Group 2 (Lestaurtinib: Dose 62.5 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
1136361|NCT00469391|E2|Reported Event|Sham Control|3 subjects withdrew before the procedure. N=26 for the ITT population.
1136362|NCT00469391|E1|Reported Event|GI Sleeve|N=26 for attempted device implant procedures. There were 2 subjects who withdrew from the study before the procedure and 4 unsuccessful procedure. Thus, N=21 for ITT population ( subjects with implanted devices).
1136309|NCT00469859|B1|Baseline|Group 1 (Lestaurtinib Dose 50 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
1136310|NCT00469859|P2|Participant Flow|Group 2 (Lestaurtinib: Dose 62.5 mg/m2)|"COURSE 1: Cytarabine IV over 2 hours twice daily days 1-4, idarubicin IV over 15 minutes days 2-4, and oral lestaurtinib twice daily days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a safe, tolerable and biologically active dose (TBAD) is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)~cytarabine"
1136311|NCT00469859|P1|Participant Flow|Group 1 (Lestaurtinib Dose 50 mg/m2)|"COURSE 1: Cytarabine IV over 2 hours twice daily days 1-4, idarubicin IV over 15 minutes days 2-4, and oral lestaurtinib twice daily days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a safe, tolerable and biologically active dose (TBAD) is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
1136312|NCT00469859|O2|Outcome|Group 2 (Lestaurtinib: Dose 62.5 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
1136332|NCT00469508|P1|Participant Flow|Modafinil|Modafinil 400mg oral dose taken daily for 12 weeks
1136333|NCT00469508|O2|Outcome|Placebo|Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
1136334|NCT00469508|O1|Outcome|Modafinil|Modafinil 400mg oral dose taken daily for 12 weeks
1138557|NCT00465101|O2|Outcome|3 Months|
1136313|NCT00469859|O1|Outcome|Group 1 (Lestaurtinib Dose 50 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
1136314|NCT00469859|O2|Outcome|Group 2 (Lestaurtinib: Dose 62.5 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
1136315|NCT00469859|O1|Outcome|Group 1 (Lestaurtinib Dose 50 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
1136363|NCT00469274|B3|Baseline|Total|Total of all reporting groups
1136364|NCT00469274|B2|Baseline|Antibiotic PEP|Enrolled subjects involved in a pertussis exposure who received post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
1136413|NCT00469079|O1|Outcome|Medicinal Nicotine|4 mg nicotine gum or lozenge
1136414|NCT00469079|O3|Outcome|Camel Snus|Camel Snus - oral tobacco product
1136415|NCT00469079|O2|Outcome|Taboka|Taboka - oral tobacco product
1136316|NCT00469859|E2|Reported Event|Group 2 (Lestaurtinib: Dose 62.5 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
1136317|NCT00469859|E1|Reported Event|Group 1 (Lestaurtinib Dose 50 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
1136318|NCT00469833|B1|Baseline|Arm 1|"Within subjects comparison; before and after treatment.~Beta-cell function measured with OGTT/hyperglycemic clamp"
1136319|NCT00469833|P1|Participant Flow|Uncontrolled Type 2 Diabetic Subjects|Eligible subjects will have measures of insulin secretion measured using the OGTT/hyperglycemic clamp technique before and after 2 months of treatment to lower blood glucose.
1136320|NCT00469833|O1|Outcome|Uncontrolled Type 2 Diabetic Subjects|
1136321|NCT00469833|O2|Outcome|IV Glucose|IV glucose administered to uncontrolled Type 2 diabetic subjects.
1136322|NCT00469833|O1|Outcome|Oral Glucose|Oral glucose administered to uncontrolled Type 2 diabetic subjects.
1136323|NCT00469833|O2|Outcome|IV Glucose|IV glucose administered to uncontrolled type 2 diabetic subjects
1136324|NCT00469833|O1|Outcome|Oral Glucose|Oral glucose administered to uncontrolled Type 2 diabetic subjects
1136325|NCT00469833|O2|Outcome|IV Glucose|IV glucose administered to uncontrolled type 2 diabetic subjects.
1136326|NCT00469833|O1|Outcome|Oral Glucose|Oral glucose administered to uncontrolled type 2 diabetic subjects.
1136327|NCT00469833|E1|Reported Event|Arm 1|"Within subjects comparison; before and after treatment.~Beta-cell function measured with OGTT/hyperglycemic clamp"
1136328|NCT00469508|B3|Baseline|Total|Total of all reporting groups
1136329|NCT00469508|B2|Baseline|Placebo|Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
1136330|NCT00469508|B1|Baseline|Modafinil|Modafinil 400mg oral dose taken daily for 12 weeks
1136331|NCT00469508|P2|Participant Flow|Placebo|Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
1138558|NCT00465101|O1|Outcome|Baseline QoL Score|
1136345|NCT00469456|B1|Baseline|Placebo|Matching placebo, oral administration, twice daily for 12 weeks
1136346|NCT00469456|P2|Participant Flow|Memantine|Memantine 20mg (10mg twice daily), oral administration for 12 weeks
1136347|NCT00469456|P1|Participant Flow|Placebo|Matching placebo, oral administration, twice daily for 12 weeks
1136348|NCT00469456|O2|Outcome|Memantine|Memantine 20mg (10mg twice daily), oral administration for 12 weeks
1136349|NCT00469456|O1|Outcome|Placebo|Matching placebo, oral administration, twice daily for 12 weeks
1136350|NCT00469456|O2|Outcome|Memantine|Memantine 20mg (10mg twice daily), oral administration for 12 weeks
1136351|NCT00469456|O1|Outcome|Placebo|Matching placebo, oral administration, twice daily for 12 weeks
1136352|NCT00469456|E2|Reported Event|Memantine|Memantine 20mg (10mg twice daily), oral administration for 12 weeks
1136353|NCT00469456|E1|Reported Event|Placebo|Matching placebo, oral administration, twice daily for 12 weeks
1136354|NCT00469391|B3|Baseline|Total|Total of all reporting groups
1136355|NCT00469391|B2|Baseline|Sham Control|Sham Procedure: Weight loss
1136356|NCT00469391|B1|Baseline|GI Sleeve|"medical device that mimics gastric bypass mechanism for weight-loss~GI Sleeve Implantable weight loss device (EndoBarrier): device for weight loss"
1136357|NCT00469391|P2|Participant Flow|Sham Control|Sham Procedure followed by standard-of-care diet therapy
1136358|NCT00469391|P1|Participant Flow|GI Sleeve|GI Sleeve Implantable weight loss device (EndoBarrier): device for weight loss followed by standard-of-care diet therapy
1136359|NCT00469391|O2|Outcome|Sham Control|Sham Procedure: Weight loss
1136360|NCT00469391|O1|Outcome|GI Sleeve|"medical device that mimics gastric bypass mechanism for weight-loss~GI Sleeve Implantable weight loss device (EndoBarrier): device for weight loss"
1136365|NCT00469274|B1|Baseline|No PEP|Enrolled subjects involved in a pertussis exposure who received no antibiotic post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
1136366|NCT00469274|P2|Participant Flow|Antibiotic PEP|Enrolled subjects involved in a pertussis exposure who received post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
1136367|NCT00469274|P1|Participant Flow|No PEP|Enrolled subjects involved in a pertussis exposure who received no antibiotic post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
1136368|NCT00469274|O2|Outcome|Antibiotic PEP|Enrolled subjects involved in a pertussis exposure who received post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
1136369|NCT00469274|O1|Outcome|No PEP|Enrolled subjects involved in a pertussis exposure who received no antibiotic post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
1136370|NCT00469274|E2|Reported Event|Antibiotic PEP|Enrolled subjects involved in a pertussis exposure who received post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
1136371|NCT00469274|E1|Reported Event|No PEP|Enrolled subjects involved in a pertussis exposure who received no antibiotic post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
1136372|NCT00469209|B4|Baseline|Total|Total of all reporting groups
1136373|NCT00469209|B3|Baseline|Bortezomib 1.5 mg/m^2|Bortezomib (Level 2) 1.5 mg/m^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
1136374|NCT00469209|B2|Baseline|Bortezomib 1.0 mg/m^2|Bortezomib (Level 1) 1.0 mg/m^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
1136375|NCT00469209|B1|Baseline|No Bortezomib|Melphalan 100 mg/m^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
1136376|NCT00469209|P3|Participant Flow|Bortezomib 1.5 mg/m^2|Bortezomib (Level 2) 1.5 mg/m^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
1136377|NCT00469209|P2|Participant Flow|Bortezomib 1.0 mg/m^2|Bortezomib (Level 1) 1.0 mg/m^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
1136378|NCT00469209|P1|Participant Flow|No Bortezomib|Melphalan 100 mg/m^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
1136379|NCT00469209|O3|Outcome|Bortezomib 1.5 mg/m^2|Bortezomib (Level 2) 1.5 mg/m^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
1136380|NCT00469209|O2|Outcome|Bortezomib 1.0 mg/m^2|Bortezomib (Level 1) 1.0 mg/m^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
1136381|NCT00469209|O1|Outcome|No Bortezomib|Melphalan 100 mg/m^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
1136382|NCT00469209|E3|Reported Event|Bortezomib 1.5 mg/m^2|Bortezomib (Level 2) 1.5 mg/m^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
1136383|NCT00469209|E2|Reported Event|Bortezomib 1.0 mg/m^2|Bortezomib (Level 1) 1.0 mg/m^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
1136384|NCT00469209|E1|Reported Event|No Bortezomib|Melphalan 100 mg/m^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
1136385|NCT00469092|B3|Baseline|Total|Total of all reporting groups
1136386|NCT00469092|B2|Baseline|Glargine|Insulin glargine + metformin + glimepiride
1136387|NCT00469092|B1|Baseline|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
1136388|NCT00469092|P2|Participant Flow|Glargine|Insulin glargine + metformin + glimepiride
1136389|NCT00469092|P1|Participant Flow|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
1136390|NCT00469092|O2|Outcome|Glargine|Insulin glargine + metformin + glimepiride
1136391|NCT00469092|O1|Outcome|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
1136392|NCT00469092|O2|Outcome|Glargine|Insulin glargine + metformin + glimepiride
1136393|NCT00469092|O1|Outcome|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
1136394|NCT00469092|O2|Outcome|Glargine|Insulin glargine + metformin + glimepiride
1136395|NCT00469092|O1|Outcome|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
1136396|NCT00469092|O2|Outcome|Glargine|Insulin glargine + metformin + glimepiride
1136397|NCT00469092|O1|Outcome|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
1136398|NCT00469092|O2|Outcome|Glargine|Insulin glargine + metformin + glimepiride
1136399|NCT00469092|O1|Outcome|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
1136400|NCT00469092|O2|Outcome|Glargine|Insulin glargine + metformin + glimepiride
1136401|NCT00469092|O1|Outcome|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
1136402|NCT00469092|E2|Reported Event|Glargine|Insulin glargine + metformin + glimepiride
1136403|NCT00469092|E1|Reported Event|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
1136404|NCT00469079|B4|Baseline|Total|Total of all reporting groups
1136405|NCT00469079|B3|Baseline|Assigned to Camel Snus|Camel Snus - oral tobacco product
1136406|NCT00469079|B2|Baseline|Assigned to Taboka|Taboka - oral tobacco product
1136407|NCT00469079|B1|Baseline|Assigned to NRT|Nicotine gum or nicotine lozenge
1136408|NCT00469079|P3|Participant Flow|Assigned to Camel Snus|Camel Snus - oral tobacco product
1136409|NCT00469079|P2|Participant Flow|Assigned to Taboka|Taboka - oral tobacco product
1136410|NCT00469079|P1|Participant Flow|Assigned to NRT|Nicotine gum or nicotine lozenge
1136416|NCT00469079|O1|Outcome|Medicinal Nicotine|Nicotine gum or nicotine lozenge
1136417|NCT00469079|O3|Outcome|Snus|A spitless, oral tobacco pouch.
1136418|NCT00469079|O2|Outcome|Taboka|A spitless, oral tobacco pouch.
1136419|NCT00469079|O1|Outcome|Medicinal Nicotine|4 mg nicotine gum or lozenge
1136420|NCT00469079|O3|Outcome|Snus|Camel Snus, a spitless oral tobacco product currently marketed as a substitute for cigarettes. The product is pasteurized rather than fermented, leading to lower tobacco specific nitrosamine levels than conventional smokeless tobacco products.
1136421|NCT00469079|O2|Outcome|Taboka|Taboka, a spitless oral tobacco product that has been discontinued. The product is pasteurized rather than fermented, leading to lower tobacco specific nitrosamine levels than conventional smokeless tobacco products.
1136422|NCT00469079|O1|Outcome|Medicinal Nicotine|4 mg nicotine gum or nicotine lozenge
1136423|NCT00469079|E3|Reported Event|Assigned to Camel Snus|Camel Snus - oral tobacco product
1136424|NCT00469079|E2|Reported Event|Assigned to Taboka|Taboka - oral tobacco product
1136425|NCT00469079|E1|Reported Event|Assigned to NRT|Nicotine gum or nicotine lozenge
1136426|NCT00468910|B3|Baseline|Total|Total of all reporting groups
1136427|NCT00468910|B2|Baseline|Placebo|Patients receive oral placebo once daily.
1136428|NCT00468910|B1|Baseline|Acetylsalicylic Acid|Patients receive oral acetylsalicylic acid (aspirin) once daily.
1136429|NCT00468910|P2|Participant Flow|Placebo|Patients receive oral placebo once daily.
1136430|NCT00468910|P1|Participant Flow|Acetylsalicylic Acid|Patients receive oral acetylsalicylic acid (aspirin) once daily.
1136431|NCT00468910|O2|Outcome|Placebo|Patients receive oral placebo once daily.
1136432|NCT00468910|O1|Outcome|Acetylsalicylic Acid|Patients receive oral acetylsalicylic acid (aspirin) once daily.
1136433|NCT00468910|O2|Outcome|Placebo|Patients receive oral placebo once daily.
1136434|NCT00468910|O1|Outcome|Acetylsalicylic Acid|Patients receive oral acetylsalicylic acid (aspirin) once daily.
1136435|NCT00468910|O2|Outcome|Placebo|Patients receive oral placebo once daily.
1136436|NCT00468910|O1|Outcome|Acetylsalicylic Acid|Patients receive oral acetylsalicylic acid (aspirin) once daily.
1136437|NCT00468910|O2|Outcome|Placebo|Patients receive oral placebo once daily.
1136438|NCT00468910|O1|Outcome|Acetylsalicylic Acid|Patients receive oral acetylsalicylic acid (aspirin) once daily.
1136439|NCT00468910|O2|Outcome|Placebo|Patients receive oral placebo once daily.
1136440|NCT00468910|O1|Outcome|Acetylsalicylic Acid|Patients receive oral acetylsalicylic acid (aspirin) 325 mg once daily.
1136441|NCT00468910|O2|Outcome|Placebo|Patients receive oral placebo once daily.
1136442|NCT00468910|O1|Outcome|Acetylsalicylic Acid|Patients receive oral acetylsalicylic acid (aspirin) 325 mg once daily.
1136443|NCT00468910|E2|Reported Event|Placebo|"Patients receive oral placebo once daily.~placebo: Given orally~laboratory biomarker analysis: Correlative study"
1136444|NCT00468910|E1|Reported Event|Acetylsalicylic Acid|"Patients receive oral acetylsalicylic acid (aspirin) once daily.~acetylsalicylic acid: Given orally~laboratory biomarker analysis: Correlative study"
1136445|NCT00468858|B4|Baseline|Total|Total of all reporting groups
1136446|NCT00468858|B3|Baseline|Placebo|"Control~Placebo: Lyophilized, single dose vials and sterile water for~> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months"
1136447|NCT00468858|B2|Baseline|T-DEN-Post-Transfection F19|"Post-Transfection F19, full dose~T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
1136448|NCT00468858|B1|Baseline|T-DEN-Post-Transfection F17|"Post-Transfection F17, full dose~T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
1136449|NCT00468858|P3|Participant Flow|Placebo|"Control~Placebo: Lyophilized, single dose vials and sterile water for~> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months"
1136450|NCT00468858|P2|Participant Flow|T-DEN-Post-Transfection F19|"Post-Transfection F19, full dose~T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
1136451|NCT00468858|P1|Participant Flow|T-DEN-Post-Transfection F17|"Post-Transfection F17, full dose~T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
1136452|NCT00468858|O36|Outcome|DEN-4, Placebo, Total|Antibody DEN-4, Placebo group, Pre-vaccination status = Total
1136453|NCT00468858|O35|Outcome|DEN-4, Placebo, S+|Antibody DEN-4, Placebo group, Pre-vaccination status = S+
1136454|NCT00468858|O34|Outcome|DEN-4, Placebo, S-|Antibody DEN-4, Placebo group, Pre-vaccination status = S-
1136455|NCT00468858|O33|Outcome|DEN-4, F19, Total|Antibody DEN-4, Group F19, Pre-vaccination status = Total
1136456|NCT00468858|O32|Outcome|DEN-4, F19, S+|Antibody DEN-4, Group F19, Pre-vaccination status = S+
1136457|NCT00468858|O31|Outcome|DEN-4, F19, S-|Antibody DEN-4, Group F19, Pre-vaccination status = S-
1136458|NCT00468858|O30|Outcome|DEN-4, F17, Total|Antibody DEN-4, Group F17, Pre-vaccination status = Total
1136459|NCT00468858|O29|Outcome|DEN-4, F17, S+|Antibody DEN-4, Group F17, Pre-vaccination status = S+
1136460|NCT00468858|O28|Outcome|DEN-4, F17, S-|Antibody DEN-4, Group F17, Pre-vaccination status = S-
1136461|NCT00468858|O27|Outcome|DEN-3, Placebo, Total|Antibody DEN-3, Placebo group, Pre-vaccination status = Total
1136462|NCT00468858|O26|Outcome|DEN-3, Placebo, S+|Antibody DEN-3, Placebo group, Pre-vaccination status = S+
1136463|NCT00468858|O25|Outcome|DEN-3, Placebo, S-|Antibody DEN-3, Placebo group, Pre-vaccination status = S-
1136464|NCT00468858|O24|Outcome|DEN-3, F19, Total|Antibody DEN-3, Group F19, Pre-vaccination status = Total
1136465|NCT00468858|O23|Outcome|DEN-3, F19, S+|Antibody DEN-3, Group F19, Pre-vaccination status = S+
1136466|NCT00468858|O22|Outcome|DEN-3, F19, S-|Antibody DEN-3, Group F19, Pre-vaccination status = S-
1136467|NCT00468858|O21|Outcome|DEN-3, F17, Total|Antibody DEN-3, Group F17, Pre-vaccination status = Total
1136468|NCT00468858|O20|Outcome|DEN-3, F17, S+|Antibody DEN-3, Group F17, Pre-vaccination status = S+
1136469|NCT00468858|O19|Outcome|DEN-3, F17, S-|Antibody DEN-3, Group F17, Pre-vaccination status = S-
1136470|NCT00468858|O18|Outcome|DEN-2, Placebo, Total|Antibody DEN-2, Placebo group, Pre-vaccination status = Total
1136471|NCT00468858|O17|Outcome|DEN-2, Placebo, S+|Antibody DEN-2, Placebo group, Pre-vaccination status = S+
1136472|NCT00468858|O16|Outcome|DEN-2, Placebo, S-|Antibody DEN-2, Placebo group, Pre-vaccination status = S-
1136473|NCT00468858|O15|Outcome|DEN-2, F19, Total|Antibody DEN-2, Group F19, Pre-vaccination status = Total
1136474|NCT00468858|O14|Outcome|DEN-2, F19, S+|Antibody DEN-2, Group F19, Pre-vaccination status = S+
1136475|NCT00468858|O13|Outcome|DEN-2, F19, S-|Antibody DEN-2, Group F19, Pre-vaccination status = S-
1136476|NCT00468858|O12|Outcome|DEN-2, F17, Total|Antibody DEN-2,. Group F17, Pre-vaccination status = Total
1136477|NCT00468858|O11|Outcome|DEN-2, F17, S+|Antibody DEN-2, Group F17, Pre-vaccination status = S+
1136478|NCT00468858|O10|Outcome|DEN-2, F17, S-|Antibody DEN-2, Group F17, Pre-vaccination status = S-
1136479|NCT00468858|O9|Outcome|DEN-1, Placebo, Total|Antibody DEN-1, Placebo group, Pre-vaccination status = Total
1136480|NCT00468858|O8|Outcome|DEN-1, Placebo, S+|Antibody DEN-1, Placebo group, Pre-vaccination status = S+
1136481|NCT00468858|O7|Outcome|DEN-1, Placebo, S-|Antibody DEN-1, Placebo group, Pre-vaccination status = S-
1136482|NCT00468858|O6|Outcome|DEN-1, F19, Total|Antibody DEN-1, Group F19, Pre-vaccination status = Total
1136483|NCT00468858|O5|Outcome|DEN-1, F19, S+|Antibody DEN-1, Group F19, Pre-vaccination group = S+
1136484|NCT00468858|O4|Outcome|DEN-1, F19, S-|Antibody DEN-1, Group F19, Pre-vaccination status = S-
1136485|NCT00468858|O3|Outcome|DEN-1, F17, Total|Antibody DEN-1, Group F17, Pre-vaccination status = Total
1136486|NCT00468858|O2|Outcome|DEN-1, F17, S+|Antibody DEN-1, Group F17, Pre-vaccination status = S+
1136487|NCT00468858|O1|Outcome|DEN-1, F17, S-|Antibody DEN-1, Group F17, Pre-vaccination status = S-
1136488|NCT00468858|O36|Outcome|DEN-4, Placebo, Total|Antibody DEN-4, Placebo group, Pre-vaccination status = Total
1136489|NCT00468858|O35|Outcome|DEN-4, Placebo, S+|Antibody DEN-4, Placebo group, Pre-vaccination status = S+
1136490|NCT00468858|O34|Outcome|DEN-4, Placebo, S-|Antibody DEN-4, Placebo group, Pre-vaccination status = S-
1136491|NCT00468858|O33|Outcome|DEN-4, F19, Total|Antibody DEN-4, Group F19, Pre-vaccination status = Total
1136492|NCT00468858|O32|Outcome|DEN-4, F19, S+|Antibody DEN-4, Group F19, Pre-vaccination status = S+
1136493|NCT00468858|O31|Outcome|DEN-4, F19, S-|Antibody DEN-4, Group F19, Pre-vaccination status = S-
1136494|NCT00468858|O30|Outcome|DEN-4, F17, Total|Antibody DEN-4, Group F17, Pre-vaccination status = Total
1136495|NCT00468858|O29|Outcome|DEN-4, F17, S+|Antibody DEN-4, Group F17, Pre-vaccination status = S+
1136496|NCT00468858|O28|Outcome|DEN-4, F17, S-|Antibody DEN-4, Group F17, Pre-vaccination status = S-
1136497|NCT00468858|O27|Outcome|DEN-3, Placebo, Total|Antibody DEN-3, Placebo group, Pre-vaccination status = Total
1136498|NCT00468858|O26|Outcome|DEN-3, Placebo, S+|Antibody DEN-3, Placebo group, Pre-vaccination status = S+
1136499|NCT00468858|O25|Outcome|DEN-3, Placebo, S-|Antibody DEN-3, Placebo group, Pre-vaccination status = S-
1136500|NCT00468858|O24|Outcome|DEN-3, F19, Total|Antibody DEN-3, Group F19, Pre-vaccination status = Total
1136501|NCT00468858|O23|Outcome|DEN-3, F19, S+|Antibody DEN-3, Group F19, Pre-vaccination status = S+
1136502|NCT00468858|O22|Outcome|DEN-3, F19, S-|Antibody DEN-3, Group F19, Pre-vaccination status = S-
1136503|NCT00468858|O21|Outcome|DEN-3, F17, Total|Antibody DEN-3, Group F17, Pre-vaccination status = Total
1136504|NCT00468858|O20|Outcome|DEN-3, F17, S+|Antibody DEN-3, Group F17, Pre-vaccination status = S+
1136505|NCT00468858|O19|Outcome|DEN-3, F17, S-|Antibody DEN-3, Group F17, Pre-vaccination status = S-
1136506|NCT00468858|O18|Outcome|DEN-2, Placebo, Total|Antibody DEN-2, Placebo group, Pre-vaccination status = Total
1136507|NCT00468858|O17|Outcome|DEN-2, Placebo, S+|Antibody DEN-2, Placebo group, Pre-vaccination status = S+
1136508|NCT00468858|O16|Outcome|DEN-2, Placebo, S-|Antibody DEN-2, Placebo group, Pre-vaccination status = S-
1136509|NCT00468858|O15|Outcome|DEN-2, F19, Total|Antibody DEN-2, Group F19, Pre-vaccination status = Total
1136510|NCT00468858|O14|Outcome|DEN-2, F19, S+|Antibody DEN-2, Group F19, Pre-vaccination status = S+
1136511|NCT00468858|O13|Outcome|DEN-2, F19, S-|Antibody DEN-2, Group F19, Pre-vaccination status = S-
1136512|NCT00468858|O12|Outcome|DEN-2, F17, Total|Antibody DEN-2,. Group F17, Pre-vaccination status = Total
1136513|NCT00468858|O11|Outcome|DEN-2, F17, S+|Antibody DEN-2, Group F17, Pre-vaccination status = S+
1136514|NCT00468858|O10|Outcome|DEN-2, F17, S-|Antibody DEN-2, Group F17, Pre-vaccination status = S-
1136515|NCT00468858|O9|Outcome|DEN-1, Placebo, Total|Antibody DEN-1, Placebo group, Pre-vaccination status = Total
1136516|NCT00468858|O8|Outcome|DEN-1, Placebo, S+|Antibody DEN-1, Placebo group, Pre-vaccination status = S+
1136517|NCT00468858|O7|Outcome|DEN-1, Placebo, S-|Antibody DEN-1, Placebo group, Pre-vaccination status = S-
1136518|NCT00468858|O6|Outcome|DEN-1, F19, Total|Antibody DEN-1, Group F19, Pre-vaccination status = Total
1136519|NCT00468858|O5|Outcome|DEN-1, F19, S+|Antibody DEN-1, Group F19, Pre-vaccination group = S+
1136520|NCT00468858|O4|Outcome|DEN-1, F19, S-|Antibody DEN-1, Group F19, Pre-vaccination status = S-
1136521|NCT00468858|O3|Outcome|DEN-1, F17, Total|Antibody DEN-1, Group F17, Pre-vaccination status = Total
1136522|NCT00468858|O2|Outcome|DEN-1, F17, S+|Antibody DEN-1, Group F17, Pre-vaccination status = S+
1136523|NCT00468858|O1|Outcome|DEN-1, F17, S-|Antibody DEN-1, Group F17, Pre-vaccination status = S-
1136524|NCT00468858|O12|Outcome|Placebo: PII (M7)|Placebo control Post-dose 2, month 7
1136525|NCT00468858|O11|Outcome|Placebo: PI (M6)|Placebo control Post-dose 1, month 6
1136526|NCT00468858|O10|Outcome|Placebo: PI (M3)|Placebo control Post-dose 1, month 3
1136527|NCT00468858|O9|Outcome|Placebo: Pre-vaccination|Pre-vaccination (blood sample taken before dose 1)
1136528|NCT00468858|O8|Outcome|F19 PII (M7)|Post-Transfection F-19 Post-dose 2, month 7
1136529|NCT00468858|O7|Outcome|F19 PI (M6)|Post-Transfection F-19 Post-dose 1, month 6
1136530|NCT00468858|O6|Outcome|F19 PI (M3)|Post-Transfection F-19 Post-dose 1, month 3
1136531|NCT00468858|O5|Outcome|F19: Pre-vaccination|Pre-vaccination (blood sample taken before dose 1)
1136532|NCT00468858|O4|Outcome|F17 PII (M7)|Post-Transfection F-17 Post-dose 2, month 7
1136533|NCT00468858|O3|Outcome|F17 PI (M6)|Post-Transfection F-17 Post-dose 1, month 6
1136534|NCT00468858|O2|Outcome|F17 PI (M3)|Post-Transfection F-17 Post-dose 1, month 3
1136535|NCT00468858|O1|Outcome|F17: Pre-vaccination|Pre-vaccination (blood sample taken before dose 1)
1136536|NCT00468858|O12|Outcome|Placebo: PII (M7)|Placebo control Post-dose 2, month 7
1136537|NCT00468858|O11|Outcome|Placebo: PI (M6)|Placebo control Post-dose 1, month 6
1136538|NCT00468858|O10|Outcome|Placebo: PI (M3)|Placebo control Post-dose 1, month 3
1136539|NCT00468858|O9|Outcome|Placebo: Pre-vaccination|Pre-vaccination (blood sample taken before dose 1)
1136540|NCT00468858|O8|Outcome|F19 PII (M7)|Post-Transfection F-19 Post-dose 2, month 7
1136541|NCT00468858|O7|Outcome|F19 PI (M6)|Post-Transfection F-19 Post-dose 1, month 6
1136542|NCT00468858|O6|Outcome|F19 PI (M3)|Post-Transfection F-19 Post-dose 1, month 3
1136543|NCT00468858|O5|Outcome|F19: Pre-vaccination|Pre-vaccination (blood sample taken before dose 1)
1136544|NCT00468858|O4|Outcome|F17 PII (M7)|Post-Transfection F-17 Post-dose 2, month 7
1136545|NCT00468858|O3|Outcome|F17 PI (M6)|Post-Transfection F-17 Post-dose 1, month 6
1136546|NCT00468858|O2|Outcome|F17 PI (M3)|Post-Transfection F-17 Post-dose 1, month 3
1136547|NCT00468858|O1|Outcome|F17: Pre-vaccination|Pre-vaccination (blood sample taken before dose 1)
1136548|NCT00468858|O2|Outcome|T-DEN-Post-Transfection F19|"Post-Transfection F19, full dose~T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
1136549|NCT00468858|O1|Outcome|T-DEN-Post-Transfection F17|"Post-Transfection F17, full dose~T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
1136550|NCT00468858|O6|Outcome|After 31-Day Post-Vaccination Period: Placebo|"Control~Placebo: Lyophilized, single dose vials and sterile water for~> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months"
1136551|NCT00468858|O5|Outcome|After 31-Day Post Vaccination Period: F19|"Post-Transfection F19, full dose~T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
1136552|NCT00468858|O4|Outcome|After 31-Day Post Vaccination Period: F17|"Post-Transfection F17, full dose~T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
1136553|NCT00468858|O3|Outcome|During 31-Day Post Vaccination: Placebo|"Control~Placebo: Lyophilized, single dose vials and sterile water for~> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months"
1136554|NCT00468858|O2|Outcome|During 31-Day Post Vaccination: F19|"Post-Transfection F19, full dose~T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
1136555|NCT00468858|O1|Outcome|During 31-Day Post Vaccination: F17|"Post-Transfection F17, full dose~T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
1136556|NCT00468858|O3|Outcome|Placebo|"Control~Placebo: Lyophilized, single dose vials and sterile water for~> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months"
1136557|NCT00468858|O2|Outcome|T-DEN-Post-Transfection F19|"Post-Transfection F19, full dose~T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
1136558|NCT00468858|O1|Outcome|T-DEN-Post-Transfection F17|"Post-Transfection F17, full dose~T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
1136559|NCT00468858|O3|Outcome|Placebo|"Control~Placebo: Lyophilized, single dose vials and sterile water for~> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months"
1136560|NCT00468858|O2|Outcome|T-DEN-Post-Transfection F19|"Post-Transfection F19, full dose~T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
1136561|NCT00468858|O1|Outcome|T-DEN-Post-Transfection F17|"Post-Transfection F17, full dose~T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
1136562|NCT00468858|O3|Outcome|Placebo|"Control~Placebo: Lyophilized, single dose vials and sterile water for~> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months"
1136563|NCT00468858|O2|Outcome|T-DEN-Post-Transfection F19|"Post-Transfection F19, full dose~T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
1138674|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
1136564|NCT00468858|O1|Outcome|T-DEN-Post-Transfection F17|"Post-Transfection F17, full dose~T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
1136565|NCT00468858|E3|Reported Event|Placebo|"Control~Placebo: Lyophilized, single dose vials and sterile water for~> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months"
1136566|NCT00468858|E2|Reported Event|T-DEN-Post-Transfection F19|"Post-Transfection F19, full dose~T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
1136567|NCT00468858|E1|Reported Event|T-DEN-Post-Transfection F17|"Post-Transfection F17, full dose~T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months"
1136568|NCT00468845|B4|Baseline|Total|Total of all reporting groups
1136569|NCT00468845|B3|Baseline|Placebo|Matching placebo capsule
1136570|NCT00468845|B2|Baseline|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136571|NCT00468845|B1|Baseline|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136572|NCT00468845|P3|Participant Flow|Placebo|Matching placebo capsule
1136573|NCT00468845|P2|Participant Flow|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136574|NCT00468845|P1|Participant Flow|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136575|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136576|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136577|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136578|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136579|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1140894|NCT00460239|O1|Outcome|Placebo 0 mg|
1136580|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136581|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136582|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136583|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136584|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136585|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136586|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136587|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136588|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136589|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136590|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136591|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136592|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136593|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136594|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136595|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136596|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136597|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136598|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136599|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136600|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136601|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136602|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136603|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136604|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136605|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136606|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136607|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136608|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136609|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136610|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136611|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136612|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136613|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136614|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136615|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136616|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136617|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136618|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136619|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136620|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136621|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136622|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136623|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136624|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136625|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136626|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136627|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136628|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136629|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136630|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136631|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136632|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136633|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136634|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136635|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136636|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136637|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136638|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136639|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136640|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136641|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136642|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136643|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136644|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136645|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136646|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136647|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136648|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136649|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136650|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136651|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136652|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136653|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136654|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136655|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136656|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136657|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136658|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136659|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136660|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136661|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136662|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136663|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136664|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136665|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136666|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136667|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136668|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136669|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136670|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136671|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136672|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136673|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136674|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136675|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136676|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136677|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136678|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136679|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136680|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136681|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136682|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136683|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136684|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136685|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136686|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136687|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136688|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136689|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136690|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136691|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136692|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136693|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136694|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136695|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136696|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136697|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136698|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136699|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136700|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136701|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
1136702|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136703|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136704|NCT00468845|E3|Reported Event|Placebo|Matching placebo capsule
1136705|NCT00468845|E2|Reported Event|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
1136706|NCT00468845|E1|Reported Event|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
1136707|NCT00468819|B4|Baseline|Total|Total of all reporting groups
1136708|NCT00468819|B3|Baseline|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136709|NCT00468819|B2|Baseline|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136710|NCT00468819|B1|Baseline|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136711|NCT00468819|P3|Participant Flow|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136712|NCT00468819|P2|Participant Flow|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136713|NCT00468819|P1|Participant Flow|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136714|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1137130|NCT00468104|O1|Outcome|Alteplase|25mg of Alteplase in 100 cc of normal saline instilled intrapleurally
1136715|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136716|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136717|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136718|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136719|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136720|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136721|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136722|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136723|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136724|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136725|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136726|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136727|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136728|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136729|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136730|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136731|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136732|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136733|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136734|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136735|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136736|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136737|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136738|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136739|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1138675|NCT00464737|O1|Outcome|Placebo|Placebo
1136740|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136741|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136742|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136743|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136744|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136745|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136746|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136747|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136748|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136749|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1137131|NCT00468104|O2|Outcome|Placebo|100 cc of normal saline instilled intrapleurally
1136750|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136751|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136752|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136753|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136754|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136755|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136756|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136757|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136758|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136759|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136760|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136761|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136762|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136763|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136764|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136765|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136766|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136767|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136768|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136769|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136770|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136771|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136772|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136773|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136774|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136775|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136776|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136777|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136778|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136779|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136780|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136781|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136782|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136783|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136784|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1137132|NCT00468104|O1|Outcome|Alteplase|25mg of Alteplase in 100 cc of normal saline instilled intrapleurally
1136785|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136786|NCT00468819|E4|Reported Event|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136787|NCT00468819|E3|Reported Event|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136788|NCT00468819|E2|Reported Event|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136789|NCT00468819|E1|Reported Event|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
1136790|NCT00468728|B3|Baseline|Total|Total of all reporting groups
1136791|NCT00468728|B2|Baseline|PAR-101/OPT-80|200 mg administered twice daily (q12hr)
1136792|NCT00468728|B1|Baseline|Vancomycin|125 mg administered 4 times daily (q6hr)
1136793|NCT00468728|P2|Participant Flow|PAR-101/OPT-80|200 mg administered twice daily (q12hr)
1136794|NCT00468728|P1|Participant Flow|Vancomycin|125 mg administered 4 times daily (q6hr)
1136795|NCT00468728|O2|Outcome|PAR-101/OPT-80|200 mg administered twice daily (q12hr)
1136796|NCT00468728|O1|Outcome|Vancomycin|125 mg administered 4 times daily (q6hr)
1136797|NCT00468728|O2|Outcome|PAR-101/OPT-80|200 mg administered twice daily
1136798|NCT00468728|O1|Outcome|Vancomycin|125 mg administered 4 times daily
1136799|NCT00468728|O2|Outcome|PAR-101/OPT-80|200 mg administered twice daily (q12hr)
1136800|NCT00468728|O1|Outcome|Vancomycin|125 mg administered 4 times daily (q6hr)
1136801|NCT00468728|E2|Reported Event|PAR-101/OPT-80|200 mg administered twice daily (q12hr)
1136802|NCT00468728|E1|Reported Event|Vancomycin|125 mg administered 4 times daily (q6hr)
1136803|NCT00468676|B3|Baseline|Total|Total of all reporting groups
1136804|NCT00468676|B2|Baseline|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psychoeducation, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
1136805|NCT00468676|B1|Baseline|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
1136806|NCT00468676|P2|Participant Flow|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psychoeducation, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 (Patient Health Questionnaire 9) scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
1136807|NCT00468676|P1|Participant Flow|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 (Patient Health Questionnaire 9) score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
1136894|NCT00468559|O1|Outcome|Open Label Esomeprazole|Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight)
1136808|NCT00468676|O2|Outcome|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psycho-education, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 (Patient Health Questionnaire 9) scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
1136809|NCT00468676|O1|Outcome|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
1136810|NCT00468676|O2|Outcome|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psycho-education, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 (Patient Health Questionnaire 9) scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
1136825|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1140895|NCT00460239|O8|Outcome|Buprenorphine 60 mg|
1136811|NCT00468676|O1|Outcome|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
1136812|NCT00468676|O2|Outcome|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psycho-education, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 (Patient Health Questionnaire 9) scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
1136813|NCT00468676|O1|Outcome|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
1136814|NCT00468676|O2|Outcome|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psycho-education, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 (Patient Health Questionnaire 9) scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
1136815|NCT00468676|O1|Outcome|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
1136816|NCT00468676|O2|Outcome|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psychoeducation, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
1136817|NCT00468676|O1|Outcome|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
1136818|NCT00468676|O2|Outcome|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psychoeducation, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
1138676|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
1136819|NCT00468676|O1|Outcome|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
1136820|NCT00468676|O1|Outcome|Effect Size of Invervention Group to Standard Care|This was an intent to treat analysis calculating the intervention effect size of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes combined
1136821|NCT00468676|E2|Reported Event|Care Management Intervention|"Care management intervention~Nurse-led case management: The case management intervention will entail approximately 10 visits with a trained nurse at the clinic or by telephone. Participants in this group will receive educational materials about how to manage diabetes and/or heart disease and stress or depression. Nurses will also provide guidance and support in managing medications, phone calls to check participants' progress, and assistance in setting personal goals and in managing physical health problems and symptoms of depression or stress."
1136822|NCT00468676|E1|Reported Event|Usual Care|"Treatment as usual~Treatment as usual: Participants will attend 10 study visits and receive 4 follow-up phone calls over 24 months. During this time, participants will receive usual care."
1136823|NCT00468650|B1|Baseline|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136824|NCT00468650|P1|Participant Flow|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1137133|NCT00468104|O2|Outcome|Placebo|Placebo in 100 cc of normal saline given daily intrapleurally for 3 days either in the first or second arm
1136826|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136827|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136828|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136829|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136830|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136831|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136832|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136833|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136834|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136835|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136836|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136837|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136895|NCT00468559|O2|Outcome|Double Blind Placebo|Participants in this group received placebo during the double-blind treatment withdrawal phase.
1137072|NCT00468299|E2|Reported Event|Mifepristone and Misoprostol|Women in this group received mifepristone 200 mg orally followed by misoprostol 800 mcg buccally
1136838|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136839|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136840|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136841|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136842|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136843|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136844|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1137272|NCT00467844|B2|Baseline|GTx-024|3 mg
1137273|NCT00467844|B1|Baseline|GTx -024|1 mg
1136845|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136846|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136847|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136848|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136849|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136850|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136851|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136852|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136853|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136854|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136855|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136856|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136857|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136858|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136859|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136860|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136861|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136862|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136863|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1137274|NCT00467844|P3|Participant Flow|3 mg of Placebo|Placebo
1137275|NCT00467844|P2|Participant Flow|GTx-024|3 mg
1136864|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136865|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136866|NCT00468650|E1|Reported Event|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
1136867|NCT00468585|B5|Baseline|Total|Total of all reporting groups
1136868|NCT00468585|B4|Baseline|Group 3|Capecitabine - AM 2000 mg; PM 2500mg; total daily 4500 mg
1136869|NCT00468585|B3|Baseline|Group 2|Capecitabine - AM 2000 mg; PM 2000 mg; total daily 4000 mg
1136870|NCT00468585|B2|Baseline|Group 1|Capecitabine - AM 1500 mg; PM 2000 mg; total daily 3500 mg
1136871|NCT00468585|B1|Baseline|Group 0|Capecitabine - AM 1500mg; PM 1500 mg; total daily 3000 mg
1136872|NCT00468585|P4|Participant Flow|Group 3|Capecitabine - AM 2000 mg; PM 2500mg; total daily 4500 mg
1136873|NCT00468585|P3|Participant Flow|Group 2|Capecitabine - AM 2000 mg; PM 2000 mg; total daily 4000 mg
1136874|NCT00468585|P2|Participant Flow|Group 1|Capecitabine - AM 1500 mg; PM 2000 mg; total daily 3500 mg
1136875|NCT00468585|P1|Participant Flow|Group 0|Capecitabine - AM 1500mg; PM 1500 mg; total daily 3000 mg
1136876|NCT00468585|O4|Outcome|Group 3|Capecitabine - AM 2000 mg; PM 2500mg; total daily 4500 mg
1136877|NCT00468585|O3|Outcome|Group 2|Capecitabine - AM 2000 mg; PM 2000 mg; total daily 4000 mg
1136878|NCT00468585|O2|Outcome|Group 1|Capecitabine - AM 1500 mg; PM 2000 mg; total daily 3500 mg
1136879|NCT00468585|O1|Outcome|Group 0|Capecitabine - AM 1500mg; PM 1500 mg; total daily 3000 mg
1136880|NCT00468585|E4|Reported Event|Group 3|Capecitabine - AM 2000 mg; PM 2500mg; total daily 4500 mg
1136881|NCT00468585|E3|Reported Event|Group 2|Capecitabine - AM 2000 mg; PM 2000 mg; total daily 4000 mg
1136882|NCT00468585|E2|Reported Event|Group 1|Capecitabine - AM 1500 mg; PM 2000 mg; total daily 3500 mg
1136883|NCT00468585|E1|Reported Event|Group 0|Capecitabine - AM 1500mg; PM 1500 mg; total daily 3000 mg
1136884|NCT00468559|B3|Baseline|Total|Total of all reporting groups
1136885|NCT00468559|B2|Baseline|Double Blind Placebo|
1136886|NCT00468559|B1|Baseline|Double Blind Esomeprazole|
1136887|NCT00468559|P3|Participant Flow|Double Blind Placebo|
1136888|NCT00468559|P2|Participant Flow|Double Blind Esomeprazole|
1136889|NCT00468559|P1|Participant Flow|Open Label Esomeprazole|Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight). Eligible participants from the Open Label phase were randomized to the the double blind withdrawal phase.
1136890|NCT00468559|O1|Outcome|Open Label Esomeprazole|Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight)
1136891|NCT00468559|O1|Outcome|Open Label Esomeprazole|Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight)
1136892|NCT00468559|O1|Outcome|Open Label Esomeprazole|Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight)
1136893|NCT00468559|O1|Outcome|Open Label Esomeprazole|Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight)
1136896|NCT00468559|O1|Outcome|Double Blind Esomeprazole|In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.
1136897|NCT00468559|O2|Outcome|Double Blind Placebo|Participants in this group received placebo during the double-blind treatment withdrawal phase.
1136898|NCT00468559|O1|Outcome|Double Blind Esomeprazole|In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.
1136899|NCT00468559|O2|Outcome|Double Blind Placebo|Participants in this group received placebo during the double-blind treatment withdrawal phase.
1136900|NCT00468559|O1|Outcome|Double Blind Esomeprazole|In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.
1136901|NCT00468559|O2|Outcome|Double Blind Placebo|Participants in this group received placebo during the double-blind treatment withdrawal phase.
1136902|NCT00468559|O1|Outcome|Double Blind Esomeprazole|In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.
1136903|NCT00468559|O2|Outcome|Double Blind Placebo|Participants in this group received placebo during the double-blind treatment withdrawal phase.
1136904|NCT00468559|O1|Outcome|Double Blind Esomeprazole|In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.
1136905|NCT00468559|O2|Outcome|Double Blind Placebo|Participants in this group received placebo during the double-blind treatment withdrawal phase.
1136906|NCT00468559|O1|Outcome|Double Blind Esomeprazole|In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.
1136907|NCT00468559|O2|Outcome|Double Blind Placebo|Participants in this group received placebo during the double-blind treatment withdrawal phase.
1136908|NCT00468559|O1|Outcome|Double Blind Esomeprazole|In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.
1136909|NCT00468559|O2|Outcome|Double Blind Placebo|Participants in this group received placebo during the double-blind treatment withdrawal phase.
1136910|NCT00468559|O1|Outcome|Double Blind Esomeprazole|In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.
1136911|NCT00468559|E3|Reported Event|Double Blind Placebo|Eligible participants from the Open Label phase were randomized to the the double blind withdrawal phase.
1136912|NCT00468559|E2|Reported Event|Double Blind Esomeprazole|Eligible participants from the Open Label phase were randomized to the the double blind withdrawal phase.
1136913|NCT00468559|E1|Reported Event|Open-label Phase|Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight).
1136914|NCT00468546|B3|Baseline|Total|Total of all reporting groups
1136915|NCT00468546|B2|Baseline|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
1136916|NCT00468546|B1|Baseline|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
1136917|NCT00468546|P2|Participant Flow|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
1136918|NCT00468546|P1|Participant Flow|Placebo Plus Methotrexate|Eligible participants were administered the placebo by intravenous infusion on Days 1 and 15 along with methotrexate (MTX) 10-25 milligrams (mg) per os (p.o.) or parenterally once a week up to Week 24 and were followed up to Week 104.
1136919|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
1136920|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
1136921|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
1136922|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
1136923|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
1136924|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
1136925|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
1136926|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
1136927|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
1138304|NCT00465972|O2|Outcome|Temazepam|1 15 mg pill of temazepam taken orally at bedtime.
1136928|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
1136929|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
1136930|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
1136931|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
1136932|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
1136933|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
1136934|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
1136935|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
1136936|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
1136937|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
1136938|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
1136939|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
1136940|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
1136941|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
1136942|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
1136943|NCT00468546|E2|Reported Event|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
1136944|NCT00468546|E1|Reported Event|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
1136945|NCT00468481|B3|Baseline|Total|Total of all reporting groups
1136946|NCT00468481|B2|Baseline|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1136947|NCT00468481|B1|Baseline|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1136948|NCT00468481|P2|Participant Flow|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1136949|NCT00468481|P1|Participant Flow|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1136950|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1136951|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1136952|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1136953|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1136954|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1136955|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1138677|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
1136956|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1136957|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1136958|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1136959|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1136960|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1136961|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1136962|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1136963|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1136964|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1137084|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
1136965|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1136966|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1136967|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1136968|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1136969|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1136970|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1136971|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1136972|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1136973|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1136974|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1136975|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1136976|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1136977|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1136978|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1136979|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1136980|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1136981|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1136982|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1136983|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1136984|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1136985|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1136986|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1136987|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1136988|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1136989|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1136990|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1137085|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
1136991|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1136992|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1136993|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1136994|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1136995|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1136996|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1136997|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1136998|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1136999|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1137000|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1137001|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1137002|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1137003|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1137004|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1137005|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1137006|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1137007|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1137008|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1137009|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1137010|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1137011|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1137012|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1137013|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1137014|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1137015|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1137016|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1137086|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
1137017|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1137018|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1137019|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1137020|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1137021|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1137022|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1137023|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1137024|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1137025|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1137026|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1137027|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1137028|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1137029|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1137030|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1137031|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1137032|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1137033|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1137034|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1137035|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1137036|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1137037|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1137038|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1137039|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1137040|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1137041|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1137042|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1137087|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
1137043|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1137044|NCT00468481|E2|Reported Event|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
1137045|NCT00468481|E1|Reported Event|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
1137046|NCT00468312|B3|Baseline|Total|Total of all reporting groups
1137047|NCT00468312|B2|Baseline|Placebo|Two sprays in each nostril once daily
1137048|NCT00468312|B1|Baseline|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
1137049|NCT00468312|P2|Participant Flow|Placebo|Two sprays in each nostril once daily
1137050|NCT00468312|P1|Participant Flow|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
1137051|NCT00468312|O2|Outcome|Placebo|Two sprays in each nostril once daily
1137052|NCT00468312|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
1137053|NCT00468312|O2|Outcome|Placebo|Two sprays in each nostril once daily
1137054|NCT00468312|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
1137055|NCT00468312|O2|Outcome|Placebo|Two sprays in each nostril once daily
1137056|NCT00468312|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
1137057|NCT00468312|O2|Outcome|Placebo|Two sprays in each nostril once daily
1137058|NCT00468312|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
1137059|NCT00468312|O2|Outcome|Placebo|Two sprays in each nostril once daily
1137060|NCT00468312|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
1137061|NCT00468312|E2|Reported Event|Placebo|Two sprays in each nostril once daily
1137062|NCT00468312|E1|Reported Event|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
1137063|NCT00468299|B3|Baseline|Total|Total of all reporting groups
1137064|NCT00468299|B2|Baseline|Mifepristone and Misoprostol|Women in this group received mifepristone 200 mg orally followed by misoprostol 800 mcg buccally
1137065|NCT00468299|B1|Baseline|Misoprostol and Placebo|Women in this groups received misoprostol (800 mcg buccally) plus a placebo for treatment of early pregnancy failure.
1137066|NCT00468299|P2|Participant Flow|Mifepristone and Misoprostol|Women in this group received mifepristone 200 mg orally followed by misoprostol 800 mcg buccally
1137067|NCT00468299|P1|Participant Flow|Misoprostol and Placebo|Women in this groups received misoprostol (800 mcg buccally) plus a placebo for treatment of early pregnancy failure.
1137068|NCT00468299|O2|Outcome|Mifepristone and Misoprostol|Women received mifeppristone 200 mg orally followed ny misoprostol 800 mcg buccally
1137069|NCT00468299|O1|Outcome|Misoprostol and Placebo|Women received a placebo followed by misoprostol 800 mcg buccally
1137070|NCT00468299|O2|Outcome|Mifepristone and Misoprostol|Women in this group received mifepristone 200 mg orally followed by misoprostol 800 mcg buccally
1137071|NCT00468299|O1|Outcome|Misoprostol and Placebo|Women in this groups received misoprostol (800 mcg buccally) plus a placebo for treatment of early pregnancy failure.
1138678|NCT00464737|O1|Outcome|Placebo|Placebo
1137073|NCT00468299|E1|Reported Event|Misoprostol and Placebo|Women in this groups received misoprostol (800 mcg buccally) plus a placebo for treatment of early pregnancy failure.
1137074|NCT00468286|B3|Baseline|Total|Total of all reporting groups
1137075|NCT00468286|B2|Baseline|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
1137076|NCT00468286|B1|Baseline|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
1137077|NCT00468286|P2|Participant Flow|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
1137078|NCT00468286|P1|Participant Flow|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
1137079|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
1137080|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
1137081|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
1137082|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
1137083|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
1137129|NCT00468104|O2|Outcome|Placebo|100 cc of normal saline instilled intrapleurally
1137088|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
1137089|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
1137090|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
1137091|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
1137092|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
1137093|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
1137094|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
1137095|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
1137096|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
1137097|NCT00468286|E2|Reported Event|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
1137098|NCT00468286|E1|Reported Event|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
1137099|NCT00468208|B1|Baseline|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.~Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:~500 mg of abatacept for body weight less than 60 kg~750 mg of abatacept for body weight between 60 and 100 kg~1000 mg of abatacept for body weight greater than 100 kg~Abatacept was administered in a 30-minute intravenous infusion."
1137100|NCT00468208|P1|Participant Flow|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.~Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:~500 mg of abatacept for body weight less than 60 kg~750 mg of abatacept for body weight between 60 and 100 kg~1000 mg of abatacept for body weight greater than 100 kg~Abatacept was administered in a 30-minute intravenous infusion."
1137101|NCT00468208|O1|Outcome|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.~Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:~500 mg of abatacept for body weight less than 60 kg~750 mg of abatacept for body weight between 60 and 100 kg~1000 mg of abatacept for body weight greater than 100 kg~Abatacept was administered in a 30-minute intravenous infusion."
1137102|NCT00468208|O1|Outcome|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.~Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:~500 mg of abatacept for body weight less than 60 kg~750 mg of abatacept for body weight between 60 and 100 kg~1000 mg of abatacept for body weight greater than 100 kg~Abatacept was administered in a 30-minute intravenous infusion."
1138305|NCT00465972|O1|Outcome|Placebo|1 sugar pill taken orally at bedtime.
1137103|NCT00468208|O1|Outcome|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.~Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:~500 mg of abatacept for body weight less than 60 kg~750 mg of abatacept for body weight between 60 and 100 kg~1000 mg of abatacept for body weight greater than 100 kg~Abatacept was administered in a 30-minute intravenous infusion."
1137104|NCT00468208|O1|Outcome|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.~Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:~500 mg of abatacept for body weight less than 60 kg~750 mg of abatacept for body weight between 60 and 100 kg~1000 mg of abatacept for body weight greater than 100 kg~Abatacept was administered in a 30-minute intravenous infusion."
1137105|NCT00468208|O1|Outcome|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.~Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:~500 mg of abatacept for body weight less than 60 kg~750 mg of abatacept for body weight between 60 and 100 kg~1000 mg of abatacept for body weight greater than 100 kg~Abatacept was administered in a 30-minute intravenous infusion."
1137106|NCT00468208|E1|Reported Event|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.~Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:~500 mg of abatacept for body weight less than 60 kg~750 mg of abatacept for body weight between 60 and 100 kg~1000 mg of abatacept for body weight greater than 100 kg~Abatacept was administered in a 30-minute intravenous infusion."
1137107|NCT00468143|B1|Baseline|All Participants|This was a randomized, crossover study in which participants received 3 weeks of treatment with MAS IR (15, 30, or 45 mg TID) and 3 weeks of treatment with MAS XR (15, 30, or 45 mg qAM). The order of the treatments (TID-qAM or qAM-TID) was counterbalanced across participants, with a washout period of ≥ 7 days between epochs.
1137276|NCT00467844|P1|Participant Flow|GTx -024|1 mg
1137108|NCT00468143|P2|Participant Flow|Immediate Release First|This group received the immediate release medication during the first three weeks of treatment and then received the extended release medication during the last 3 weeks of treatment.
1137109|NCT00468143|P1|Participant Flow|Extended Release First|This group received the extended release medication during the first three weeks of treatment and then received the immediate release medication during the last 3 weeks of treatment.
1137110|NCT00468143|O2|Outcome|Adderall XR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (15 mg qAM for Adderall XR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
1137111|NCT00468143|O1|Outcome|Adderall IR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (5 mg TID for Adderall IR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
1137112|NCT00468143|O2|Outcome|Adderall XR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (15 mg qAM for Adderall XR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
1137113|NCT00468143|O1|Outcome|Adderall IR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (5 mg TID for Adderall IR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
1137114|NCT00468143|O2|Outcome|Adderall XR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (15 mg qAM for Adderall XR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
1137115|NCT00468143|O1|Outcome|Adderall IR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (5 mg TID for Adderall IR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
1137116|NCT00468143|O2|Outcome|Adderall XR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (15 mg qAM for Adderall XR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
1137117|NCT00468143|O1|Outcome|Adderall IR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (5 mg TID for Adderall IR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
1137118|NCT00468143|O2|Outcome|Adderall XR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (15 mg qAM for Adderall XR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
1137119|NCT00468143|O1|Outcome|Adderall IR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (5 mg TID for Adderall IR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
1137120|NCT00468143|E2|Reported Event|Immediate Release|This was a randomized, crossover study in which participants received 3 weeks of treatment with MAS IR (15, 30, or 45 mg TID) and 3 weeks of treatment with MAS XR (15, 30, or 45 mg qAM). The order of the treatments (TID-qAM or qAM-TID) was counterbalanced across participants, with a washout period of ≥ 7 days between epochs.
1137121|NCT00468143|E1|Reported Event|Extended Release|This was a randomized, crossover study in which participants received 3 weeks of treatment with MAS IR (15, 30, or 45 mg TID) and 3 weeks of treatment with MAS XR (15, 30, or 45 mg qAM). The order of the treatments (TID-qAM or qAM-TID) was counterbalanced across participants, with a washout period of ≥ 7 days between epochs.
1137122|NCT00468104|B1|Baseline|Alteplase; Placebo|25mg of Alteplase in 100 cc of normal saline instilled intrapleurally; 100 cc of normal saline instilled intrapleurally
1137123|NCT00468104|P2|Participant Flow|Placebo Then Alteplase|Placebo in 100 cc of normal saline was instilled intrapleurally daily for three days. Chest CT scans were performed on the fourth day . If less than a 50% reduction in the pleural effusion was determined, the patient was given the option to go to surgery or to the second intervention of the trial (with Alteplase)
1137124|NCT00468104|P1|Participant Flow|Alteplase Then Placebo|25 mg of Alteplase in 100 cc of normal saline was instilled intrapleurally daily for three days. Chest CT scans were performed on the fourth day . If less than a 50% reduction in the pleural effusion was determined, the patient was given the option to go to surgery or to the second intervention of the trial (with Placebo)
1137125|NCT00468104|O2|Outcome|Placebo|100 cc of normal saline instilled intrapleurally
1137126|NCT00468104|O1|Outcome|Alteplase|25mg of Alteplase in 100 cc of normal saline instilled intrapleurally
1137127|NCT00468104|O2|Outcome|Placebo|100 cc of normal saline instilled intrapleurally
1137128|NCT00468104|O1|Outcome|Alteplase|25mg of Alteplase in 100 cc of normal saline instilled intrapleurally
1137134|NCT00468104|O1|Outcome|Alteplase|25mg of Alteplase in 100 cc of normal saline given intrapleurally daily for 3 days either in the first or second arm
1137135|NCT00468104|E3|Reported Event|Received Both Alteplase and Placebo|These patients were crossed over and received both Alteplase and Placebo
1137136|NCT00468104|E2|Reported Event|Received Placebo Only|These patients received Placebo only and were not crossed over
1137137|NCT00468104|E1|Reported Event|Received Alteplase Only|These patients received only Alteplase and were not crossed over
1137138|NCT00468052|B3|Baseline|Total|Total of all reporting groups
1137139|NCT00468052|B2|Baseline|Dexmedetomidine|61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
1137140|NCT00468052|B1|Baseline|Fentanyl (F) Group|"61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established.~0"
1137141|NCT00468052|P2|Participant Flow|Dexmedetomidine|61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
1137142|NCT00468052|P1|Participant Flow|Fentanyl (F) Group|"61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established.~0"
1137143|NCT00468052|O2|Outcome|Dexmedetomidine|"dexmedetomidine 2ug.kg-1 over 10 min followed by 0.7ug.kg-1.h-1~dexmedetomidine: 2 micrograms/kilogram as a bolus then 0.7 micrograms/kilogram infusion"
1137144|NCT00468052|O1|Outcome|Fentanyl|"fentanyl bolus 1ug.kg-1~fentanyl: 1 microgram/kilogram as a bolus"
1137145|NCT00468052|O2|Outcome|Dexmedetomidine|"dexmedetomidine 2ug.kg-1 over 10 min followed by 0.7ug.kg-1.h-1~dexmedetomidine: 2 micrograms/kilogram as a bolus then 0.7 micrograms/kilogram infusion"
1137146|NCT00468052|O1|Outcome|Fentanyl|"fentanyl bolus 1ug.kg-1~fentanyl: 1 microgram/kilogram as a bolus"
1137147|NCT00468052|O2|Outcome|Dexmedetomidine|61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
1137148|NCT00468052|O1|Outcome|Fentanyl (F) Group|"61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established.~0"
1137149|NCT00468052|O2|Outcome|Dexmedetomidine|61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
1137150|NCT00468052|O1|Outcome|Fentanyl (F) Group|"61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established.~0"
1137151|NCT00468052|O2|Outcome|Dexmedetomidine|61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
1137152|NCT00468052|O1|Outcome|Fentanyl (F) Group|"61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established.~0"
1137153|NCT00468052|O2|Outcome|Dexmedetomidine|"dexmedetomidine 2ug.kg-1 over 10 min followed by 0.7ug.kg-1.h-1~dexmedetomidine: 2 micrograms/kilogram as a bolus then 0.7 micrograms/kilogram infusion"
1137154|NCT00468052|O1|Outcome|Fentanyl|"fentanyl bolus 1ug.kg-1~fentanyl: 1 microgram/kilogram as a bolus"
1137155|NCT00468052|O2|Outcome|Dexmedetomidine|61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
1137156|NCT00468052|O1|Outcome|Fentanyl (F) Group|"61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established.~0"
1137157|NCT00468052|E2|Reported Event|Dexmedetomidine|1 subjects Group D experienced an adverse event.
1137158|NCT00468052|E1|Reported Event|Fentanyl (F) Group|"No subjects in group F experienced an adverse event.~0"
1137159|NCT00467961|B1|Baseline|Selective T Cell Depletion Transplant Recipients|Subjects will receive a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation, followed by an infusion of a stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a lymphocyte product that has been selectively depleted using the photodepletion approach. Older subjects will receive a lower dose of irradiation to reduce the regimen intensity. To determine appropriate level of post transplant immunosuppression, a three sequential de-escalation stage design for timing of cyclosporine will be utilized.
1137193|NCT00467870|P3|Participant Flow|B-TU 750 mg|1000 mg TU in 4 mL oily solution, IM at baseline, and then 750 mg TU in 3 mL oily solution at week 8 and again every 10 weeks for up to 23 months in Part B
1137160|NCT00467961|P1|Participant Flow|Selective T Cell Depletion Transplant Recipients|Subjects will receive a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation, followed by an infusion of a stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a lymphocyte product that has been selectively depleted using the photodepletion approach. Older subjects will receive a lower dose of irradiation to reduce the regimen intensity. To determine appropriate level of post transplant immunosuppression, a three sequential de-escalation stage design for timing of cyclosporine will be utilized.
1137161|NCT00467961|O1|Outcome|Selective T Cell Depletion Transplant Recipients|"Subjects will receive a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation, followed by an infusion of a stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a lymphocyte product that has been selectively depleted using the photodepletion approach (Kiadis Pharma). Older subjects will receive a lower dose of irradiation to reduce the regimen intensity.~To determine appropriate level of post transplant immunosuppression."
1137162|NCT00467961|E1|Reported Event|Selective T Cell Depletion Transplant Recipients|Subjects will receive a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation, followed by an infusion of a stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a lymphocyte product that has been selectively depleted using the photodepletion approach. Older subjects will receive a lower dose of irradiation to reduce the regimen intensity. To determine appropriate level of post transplant immunosuppression, a three sequential de-escalation stage design for timing of cyclosporine will be utilized.
1137163|NCT00467896|B1|Baseline|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
1137164|NCT00467896|P1|Participant Flow|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
1137165|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) in Period I and Power Disc-15 (PD-15)in Period II.
1137166|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
1137167|NCT00467896|O1|Outcome|Iloprost PD-6|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
1137168|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
1137169|NCT00467896|O1|Outcome|Iloprost PD-6|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
1137170|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
1137171|NCT00467896|O1|Outcome|Iloprost PD-6|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
1137172|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
1137173|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
1137174|NCT00467896|O1|Outcome|Iloprost PD-6|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
1137175|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
1137176|NCT00467896|O1|Outcome|Iloprost PD-6|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
1137177|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
1137178|NCT00467896|O1|Outcome|Iloprost PD-6|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
1137179|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
1137180|NCT00467896|O1|Outcome|Iloprost PD-6|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
1137181|NCT00467896|O1|Outcome|Iloprost PD-6|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
1137182|NCT00467896|E1|Reported Event|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
1137183|NCT00467870|B7|Baseline|Total|Total of all reporting groups
1137184|NCT00467870|B6|Baseline|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
1137185|NCT00467870|B5|Baseline|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
1137186|NCT00467870|B4|Baseline|B-TU 1000 mg|1000 mg TU in 4 mL oily solution, IM at baseline, week 8, and then every 12 weeks for up to 24 months in Part B
1137187|NCT00467870|B3|Baseline|B-TU 750 mg|1000 mg TU in 4 mL oily solution, IM at baseline, and then 750 mg TU in 3 mL oily solution at week 8 and again every 10 weeks for up to 23 months in Part B
1137188|NCT00467870|B2|Baseline|A-TU 1000 mg|1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
1137189|NCT00467870|B1|Baseline|A-TU 750 mg|750 mg TU in 3 mL oily solution, IM every 12 weeks for up to 3 years in Part A
1137190|NCT00467870|P6|Participant Flow|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
1137191|NCT00467870|P5|Participant Flow|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
1137192|NCT00467870|P4|Participant Flow|B-TU 1000 mg|1000 mg TU in 4 mL oily solution, IM at baseline, week 8, and then every 12 weeks for up to 24 months in Part B
1137194|NCT00467870|P2|Participant Flow|A-TU 1000 mg|1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
1137195|NCT00467870|P1|Participant Flow|A-TU 750 mg|750 mg testosterone undecanoate (TU) in 3 mL oily solution, intramuscularly (IM) every 12 weeks for up to 3 years in Part A
1137196|NCT00467870|O1|Outcome|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
1137197|NCT00467870|O1|Outcome|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
1137198|NCT00467870|O1|Outcome|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
1137199|NCT00467870|O1|Outcome|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
1137200|NCT00467870|O1|Outcome|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
1137201|NCT00467870|O1|Outcome|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
1137202|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
1137203|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
1137204|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
1137205|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
1137206|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
1137207|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
1137208|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
1137209|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
1137210|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
1137211|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
1137212|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
1137213|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
1137214|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
1137215|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
1137216|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
1137217|NCT00467870|O2|Outcome|B-TU 1000 mg|1000 mg TU in 4 mL oily solution, IM at baseline, week 8, and then every 12 weeks for up to 24 months in Part B
1137218|NCT00467870|O1|Outcome|B-TU 750 mg|1000 mg TU in 4 mL oily solution, IM at baseline, and then 750 mg TU in 3 mL oily solution at week 8 and again every 10 weeks for up to 23 months in Part B
1137219|NCT00467870|O2|Outcome|A-TU 1000 mg|1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A
1137220|NCT00467870|O1|Outcome|A-TU 750 mg|750 mg TU in 3 mL oily solution, IM every 12 weeks for up to 3 years in Part A
1137221|NCT00467870|O1|Outcome|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
1137222|NCT00467870|O1|Outcome|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
1137223|NCT00467870|O1|Outcome|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
1137224|NCT00467870|O1|Outcome|C2-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2
1137225|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
1137226|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
1137227|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
1137228|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
1137229|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
1137230|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
1137231|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
1137232|NCT00467870|O1|Outcome|C-TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C
1137233|NCT00467870|E2|Reported Event|TU 1000 mg|1000 mg TU in 4 mL oily solution, IM at any time during the study in Part A or B (includes participants from A-1000 mg, B-750 mg, and B-1000 mg)
1137234|NCT00467870|E1|Reported Event|TU 750 mg|750 mg TU in 3 mL oily solution, IM at baseline and during the study in Part A, C, or C2 (includes participants from A-750 mg, C-750 mg, and C2-750 mg)
1137235|NCT00467857|B3|Baseline|Total|Total of all reporting groups
1137236|NCT00467857|B2|Baseline|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
1137514|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137515|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1138538|NCT00465101|O1|Outcome|Length of Catheterization|
1137237|NCT00467857|B1|Baseline|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
1137238|NCT00467857|P2|Participant Flow|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
1137239|NCT00467857|P1|Participant Flow|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
1137240|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
1137241|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
1137242|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
1137243|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
1137244|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
1137245|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
1137277|NCT00467844|O3|Outcome|3 mg of Placebo|Placebo
1137246|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
1137247|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
1137248|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
1137249|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
1137250|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
1137251|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
1137252|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
1137253|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
1137254|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
1137255|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
1137256|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
1137257|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
1137258|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
1137259|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
1137260|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
1137261|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
1137262|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
1137263|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
1137264|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
1137265|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
1137266|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
1137267|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
1137268|NCT00467857|E2|Reported Event|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
1137269|NCT00467857|E1|Reported Event|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
1137270|NCT00467844|B4|Baseline|Total|Total of all reporting groups
1137271|NCT00467844|B3|Baseline|3 mg of Placebo|Placebo
1137286|NCT00467831|B1|Baseline|Multi-Drug Regimen|"Losartan, 25 mg by mouth every night at bedtime; Zileuton, 1200 mg by mouth twice daily; N-acetylcysteine, 600 mg by mouth three times daily; Pravastatin, 20 mg by mouth every night at bedtime; Erythromycin, 333 mg by mouth three times daily.~Erythromycin : Erythromycin tablet, 333 mg by mouth three times daily.~Losartan : Losartan potassium tablet, 25 mg by mouth every night at bedtime.~Zileuton : Zileuton tablet, 1200 mg by mouth twice daily.~N-Acetylcysteine : N-acetylcysteine solution, 600 mg by mouth three times daily.~Pravastatin : Pravastatin sodium tablet, 20 mg by mouth every night at bedtime."
1137287|NCT00467831|P1|Participant Flow|Multi-Drug Regimen|"Losartan, 25 mg by mouth every night at bedtime; Zileuton, 1200 mg by mouth twice daily; N-acetylcysteine, 600 mg by mouth three times daily; Pravastatin, 20 mg by mouth every night at bedtime; Erythromycin, 333 mg by mouth three times daily.~Erythromycin : Erythromycin tablet, 333 mg by mouth three times daily.~Losartan : Losartan potassium tablet, 25 mg by mouth every night at bedtime.~Zileuton : Zileuton tablet, 1200 mg by mouth twice daily.~N-Acetylcysteine : N-acetylcysteine solution, 600 mg by mouth three times daily.~Pravastatin : Pravastatin sodium tablet, 20 mg by mouth every night at bedtime."
1137288|NCT00467831|O1|Outcome|Multi-Drug Regimen|"Losartan, 25 mg by mouth every night at bedtime; Zileuton, 1200 mg by mouth twice daily; N-acetylcysteine, 600 mg by mouth three times daily; Pravastatin, 20 mg by mouth every night at bedtime; Erythromycin, 333 mg by mouth three times daily.~Erythromycin : Erythromycin tablet, 333 mg by mouth three times daily.~Losartan : Losartan potassium tablet, 25 mg by mouth every night at bedtime.~Zileuton : Zileuton tablet, 1200 mg by mouth twice daily.~N-Acetylcysteine : N-acetylcysteine solution, 600 mg by mouth three times daily.~Pravastatin : Pravastatin sodium tablet, 20 mg by mouth every night at bedtime."
1137289|NCT00467831|E1|Reported Event|Multi-Drug Regimen|"Losartan, 25 mg by mouth every night at bedtime; Zileuton, 1200 mg by mouth twice daily; N-acetylcysteine, 600 mg by mouth three times daily; Pravastatin, 20 mg by mouth every night at bedtime; Erythromycin, 333 mg by mouth three times daily.~Erythromycin : Erythromycin tablet, 333 mg by mouth three times daily.~Losartan : Losartan potassium tablet, 25 mg by mouth every night at bedtime.~Zileuton : Zileuton tablet, 1200 mg by mouth twice daily.~N-Acetylcysteine : N-acetylcysteine solution, 600 mg by mouth three times daily.~Pravastatin : Pravastatin sodium tablet, 20 mg by mouth every night at bedtime."
1137290|NCT00467779|B16|Baseline|Total|Total of all reporting groups
1137291|NCT00467779|B15|Baseline|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. In Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
1137292|NCT00467779|B14|Baseline|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137293|NCT00467779|B13|Baseline|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137294|NCT00467779|B12|Baseline|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1138539|NCT00465101|O1|Outcome|Length of Hospital Stay (Hours)|
1137295|NCT00467779|B11|Baseline|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137296|NCT00467779|B10|Baseline|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137297|NCT00467779|B9|Baseline|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137298|NCT00467779|B8|Baseline|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137299|NCT00467779|B7|Baseline|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137300|NCT00467779|B6|Baseline|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137301|NCT00467779|B5|Baseline|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137302|NCT00467779|B4|Baseline|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137552|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137303|NCT00467779|B3|Baseline|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137304|NCT00467779|B2|Baseline|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137305|NCT00467779|B1|Baseline|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137306|NCT00467779|P15|Participant Flow|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. In Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
1137307|NCT00467779|P14|Participant Flow|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137308|NCT00467779|P13|Participant Flow|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137309|NCT00467779|P12|Participant Flow|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137310|NCT00467779|P11|Participant Flow|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137311|NCT00467779|P10|Participant Flow|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137312|NCT00467779|P9|Participant Flow|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137313|NCT00467779|P8|Participant Flow|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137314|NCT00467779|P7|Participant Flow|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137315|NCT00467779|P6|Participant Flow|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137316|NCT00467779|P5|Participant Flow|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137317|NCT00467779|P4|Participant Flow|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137318|NCT00467779|P3|Participant Flow|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137319|NCT00467779|P2|Participant Flow|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137320|NCT00467779|P1|Participant Flow|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 milligrams per kilograms (mg/kg) via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137337|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137321|NCT00467779|O1|Outcome|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. in Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
1137322|NCT00467779|O1|Outcome|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. in Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
1137323|NCT00467779|O1|Outcome|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. in Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
1137324|NCT00467779|O1|Outcome|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. in Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
1137325|NCT00467779|O1|Outcome|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. in Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
1137326|NCT00467779|O1|Outcome|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. in Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
1137327|NCT00467779|O1|Outcome|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137516|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1138540|NCT00465101|O1|Outcome|Return to Activity (Days)|
1137328|NCT00467779|O1|Outcome|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137329|NCT00467779|O1|Outcome|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137330|NCT00467779|O1|Outcome|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137331|NCT00467779|O1|Outcome|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137332|NCT00467779|O1|Outcome|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137333|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137334|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137335|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137336|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137338|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137339|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137340|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137341|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137342|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137343|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137344|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137345|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137346|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137347|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137348|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137517|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1138541|NCT00465101|O8|Outcome|5 Years|
1137349|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137350|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137351|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137352|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137353|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137354|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137355|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137356|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137357|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1140896|NCT00460239|O7|Outcome|Buprenorphine 48 mg|
1137358|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137359|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137360|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137361|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137362|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137363|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137364|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137365|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137366|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137367|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137368|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137369|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137370|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137371|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137372|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137373|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137374|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137375|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137376|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137377|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137378|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137379|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137380|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137381|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137382|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137383|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137384|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137385|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137386|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137387|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137388|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137518|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137389|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137390|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137391|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137392|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137393|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137394|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137395|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137396|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137397|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1138439|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1137398|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137399|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137400|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137401|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137402|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137403|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137404|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137405|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137406|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137407|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137519|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137520|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1138542|NCT00465101|O7|Outcome|4 Years|
1137408|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137409|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137410|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137411|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137412|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137413|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137414|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137415|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137416|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137417|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137547|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1140897|NCT00460239|O6|Outcome|Buprenorphine 32 mg|
1137418|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137419|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137420|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137421|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137422|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137423|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137424|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137425|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137426|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137427|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137428|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137429|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137430|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137431|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137432|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137433|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137434|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137435|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137436|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137437|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137438|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137439|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137440|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137441|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137442|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137443|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137444|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137445|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137446|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137447|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1138543|NCT00465101|O6|Outcome|3 Year|
1137448|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137449|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137450|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137451|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137452|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137453|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137454|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137455|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137456|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137457|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137548|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1140898|NCT00460239|O5|Outcome|Buprenorphine 16 mg|
1137458|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137459|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137460|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137461|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137462|NCT00467779|O1|Outcome|Stage 1A - All Cohorts (14/14)|Participants received cobimetinib via solution or capsule, once daily for Days 1-14 of each 28-day cycle and were on a 14-days-on and 14-days-off schedule. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137463|NCT00467779|O1|Outcome|Stage 1 All Cohorts (21/7)|Participants received cobimetinib via solution or capsule, once daily for Days 1-21 of each 28-day cycle and were on 21-days-on and 7-days-off schedule. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137464|NCT00467779|O12|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137465|NCT00467779|O11|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137466|NCT00467779|O10|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137521|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137522|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137467|NCT00467779|O9|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137468|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137469|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137470|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137471|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137472|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137473|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137474|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137475|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137476|NCT00467779|E15|Reported Event|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period. Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. in Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
1138440|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1137477|NCT00467779|E14|Reported Event|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137478|NCT00467779|E13|Reported Event|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137479|NCT00467779|E12|Reported Event|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137480|NCT00467779|E11|Reported Event|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137481|NCT00467779|E10|Reported Event|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137482|NCT00467779|E9|Reported Event|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137483|NCT00467779|E8|Reported Event|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137484|NCT00467779|E7|Reported Event|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137485|NCT00467779|E6|Reported Event|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137486|NCT00467779|E5|Reported Event|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137487|NCT00467779|E4|Reported Event|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137488|NCT00467779|E3|Reported Event|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137489|NCT00467779|E2|Reported Event|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137490|NCT00467779|E1|Reported Event|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
1137491|NCT00467753|B3|Baseline|Total|Total of all reporting groups
1137492|NCT00467753|B2|Baseline|Sugar Pill|Placebo : Dosage similar to active drug
1137493|NCT00467753|B1|Baseline|Oxcarbazepine|"Oxcarbazepine is the active drug to be given to subjects in the experimental arm~Oxcarbazepine : Oxcarbazepine is available in a 300mg/5ml solution. Dosage will start at 150 mg (2.5ml) at night for 3 days and will be increased to 150 mg in the am and pm. For children who are able to tolerate the 150 mg BID dose, the oxcarbazepine will be increased to 300 mg at night and 150 mg in the AM for 3 days and 300 mg BID for the next week. The children will remain on this dose until week 3, at which time if they are tolerating the medication and do not have a CGI of 1 (very much improved) they will be increased to 600 mg twice a day in a method similar to the above increases. After week 4, the child will remain on the same stable dose."
1137494|NCT00467753|P2|Participant Flow|Sugar Pill|Placebo : Dosage similar to active drug
1137495|NCT00467753|P1|Participant Flow|Oxcarbazepine|"Oxcarbazepine is the active drug to be given to subjects in the experimental arm~Oxcarbazepine : Oxcarbazepine is available in a 300mg/5ml solution. Dosage will start at 150 mg (2.5ml) at night for 3 days and will be increased to 150 mg in the am and pm. For children who are able to tolerate the 150 mg BID dose, the oxcarbazepine will be increased to 300 mg at night and 150 mg in the AM for 3 days and 300 mg BID for the next week. The children will remain on this dose until week 3, at which time if they are tolerating the medication and do not have a CGI of 1 (very much improved) they will be increased to 600 mg twice a day in a method similar to the above increases. After week 4, the child will remain on the same stable dose."
1137496|NCT00467753|O2|Outcome|Sugar Pill|Placebo : Dosage similar to active drug
1137549|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137550|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137551|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1140899|NCT00460239|O4|Outcome|Buprenorphine 8 mg|
1137497|NCT00467753|O1|Outcome|Oxcarbazepine|"Oxcarbazepine is the active drug to be given to subjects in the experimental arm~Oxcarbazepine : Oxcarbazepine is available in a 300mg/5ml solution. Dosage will start at 150 mg (2.5ml) at night for 3 days and will be increased to 150 mg in the am and pm. For children who are able to tolerate the 150 mg BID dose, the oxcarbazepine will be increased to 300 mg at night and 150 mg in the AM for 3 days and 300 mg BID for the next week. The children will remain on this dose until week 3, at which time if they are tolerating the medication and do not have a CGI of 1 (very much improved) they will be increased to 600 mg twice a day in a method similar to the above increases. After week 4, the child will remain on the same stable dose."
1137498|NCT00467753|E2|Reported Event|Sugar Pill|Placebo : Dosage similar to active drug
1137499|NCT00467753|E1|Reported Event|Oxcarbazepine|"Oxcarbazepine is the active drug to be given to subjects in the experimental arm~Oxcarbazepine : Oxcarbazepine is available in a 300mg/5ml solution. Dosage will start at 150 mg (2.5ml) at night for 3 days and will be increased to 150 mg in the am and pm. For children who are able to tolerate the 150 mg BID dose, the oxcarbazepine will be increased to 300 mg at night and 150 mg in the AM for 3 days and 300 mg BID for the next week. The children will remain on this dose until week 3, at which time if they are tolerating the medication and do not have a CGI of 1 (very much improved) they will be increased to 600 mg twice a day in a method similar to the above increases. After week 4, the child will remain on the same stable dose."
1137500|NCT00467740|B6|Baseline|Total|Total of all reporting groups
1137501|NCT00467740|B5|Baseline|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137502|NCT00467740|B4|Baseline|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137503|NCT00467740|B3|Baseline|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137504|NCT00467740|B2|Baseline|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137505|NCT00467740|B1|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137506|NCT00467740|P5|Participant Flow|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137507|NCT00467740|P4|Participant Flow|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137508|NCT00467740|P3|Participant Flow|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137509|NCT00467740|P2|Participant Flow|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137510|NCT00467740|P1|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137511|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137512|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137513|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137523|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137524|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137525|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137526|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137527|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137528|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137529|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137530|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137531|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137532|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137533|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137534|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137535|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137536|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137537|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137538|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137539|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137540|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137541|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137542|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137543|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137544|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137545|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137546|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137553|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137554|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137555|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137556|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137557|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137558|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137559|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137560|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137561|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137562|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137563|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137564|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137565|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137566|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137567|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137568|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137569|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137570|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137571|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137572|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137573|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137574|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137575|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137576|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137577|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137578|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137579|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137580|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137581|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137582|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137583|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137584|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137585|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137586|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137587|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137588|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137589|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137590|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137591|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137592|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137593|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137594|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137595|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137596|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137597|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137598|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137599|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137600|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137601|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137602|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137603|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137604|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137605|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137606|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137607|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137608|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137609|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137610|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137611|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137612|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137613|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137614|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137615|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137616|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137617|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137618|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137619|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137620|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137621|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137622|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137623|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137624|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137625|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137626|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137627|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137628|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137629|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137630|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137631|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137632|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137633|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137634|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137635|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137636|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137637|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137638|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137639|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137640|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137641|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137642|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137643|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137644|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137645|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137646|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137647|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137648|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137649|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137650|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137651|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137652|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137653|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137654|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137655|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137656|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137657|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137658|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137659|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137660|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137661|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137662|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137663|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137664|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137665|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137666|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137667|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137668|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137669|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137670|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137671|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137672|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137673|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137674|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137675|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137676|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137677|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137678|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137679|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137680|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137681|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137682|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137683|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137684|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137685|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137686|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137687|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137688|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137689|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137690|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137691|NCT00467740|E5|Reported Event|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1137692|NCT00467740|E4|Reported Event|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1137693|NCT00467740|E3|Reported Event|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1137694|NCT00467740|E2|Reported Event|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1137695|NCT00467740|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1137696|NCT00467649|B3|Baseline|Total|Total of all reporting groups
1137697|NCT00467649|B2|Baseline|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
1137698|NCT00467649|B1|Baseline|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
1137699|NCT00467649|P6|Participant Flow|Group F (Phase 2 RA Insulin + SYMLIN)|Patients from Group B, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated SYMLIN during Phase 2
1137700|NCT00467649|P5|Participant Flow|Group E (Phase 2 RA Insulin)|Patients from Group B, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
1137701|NCT00467649|P4|Participant Flow|Group D (Phase 2 SYMLIN+RA)|Patients from Group A, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated RA insulin during Phase 2
1137702|NCT00467649|P3|Participant Flow|Group C (Phase 2 SYMLIN)|Patients from Group A, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
1137703|NCT00467649|P2|Participant Flow|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
1138544|NCT00465101|O5|Outcome|2 Years|
1137704|NCT00467649|P1|Participant Flow|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
1137705|NCT00467649|O6|Outcome|Group F (Phase 2 RA Insulin + SYMLIN)|Patients from Group B, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated SYMLIN during Phase 2
1137706|NCT00467649|O5|Outcome|Group E (Phase 2 RA Insulin)|Patients from Group B, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
1137707|NCT00467649|O4|Outcome|Group D (Phase 2 SYMLIN+RA)|Patients from Group A, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated RA insulin during Phase 2
1137708|NCT00467649|O3|Outcome|Group C (Phase 2 SYMLIN)|Patients from Group A, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
1137709|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
1137710|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
1137711|NCT00467649|O4|Outcome|Group F (Phase 2 RA Insulin + SYMLIN)|Patients from Group B, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated SYMLIN during Phase 2
1137712|NCT00467649|O3|Outcome|Group E (Phase 2 RA Insulin)|Patients from Group B, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
1137713|NCT00467649|O2|Outcome|Group D (Phase 2 SYMLIN+RA)|Patients from Group A, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated RA insulin during Phase 2
1137714|NCT00467649|O1|Outcome|Group C (Phase 2 SYMLIN)|Patients from Group A, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
1137715|NCT00467649|O4|Outcome|Group F (Phase 2 RA Insulin + SYMLIN)|Patients from Group B, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated SYMLIN during Phase 2
1137716|NCT00467649|O3|Outcome|Group E (Phase 2 RA Insulin)|Patients from Group B, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
1137717|NCT00467649|O2|Outcome|Group D (Phase 2 SYMLIN+RA)|Patients from Group A, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated RA insulin during Phase 2
1137718|NCT00467649|O1|Outcome|Group C (Phase 2 SYMLIN)|Patients from Group A, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
1140900|NCT00460239|O3|Outcome|Morphine 30 mg|
1137719|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
1137720|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
1137721|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
1137722|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
1137723|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
1137724|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
1137725|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
1137726|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
1137727|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
1137728|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
1137729|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
1137730|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
1137731|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
1137732|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
1137733|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
1137734|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
1137735|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
1137736|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
1137737|NCT00467649|E6|Reported Event|Group F (Phase 2 RA Insulin + SYMLIN)|Patients from Group B, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated SYMLIN during Phase 2
1137738|NCT00467649|E5|Reported Event|Group E (Phase 2 RA Insulin)|Patients from Group B, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
1137882|NCT00467259|O2|Outcome|Testosterone|Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
1138545|NCT00465101|O4|Outcome|1 Year|
1137739|NCT00467649|E4|Reported Event|Group D (Phase 2 SYMLIN+RA)|Patients from Group A, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated RA insulin during Phase 2
1137740|NCT00467649|E3|Reported Event|Group C (Phase 2 SYMLIN)|Patients from Group A, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
1137741|NCT00467649|E2|Reported Event|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
1137742|NCT00467649|E1|Reported Event|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
1137743|NCT00467610|B1|Baseline|Group 1|Panhematin treatment arm
1137744|NCT00467610|P1|Participant Flow|Group 1|Panhematin treatment arm
1137745|NCT00467610|O1|Outcome|Group 1|Panhematin treatment arm
1137746|NCT00467610|O1|Outcome|Group 1|Panhematin treatment arm
1137747|NCT00467610|O1|Outcome|Group 1|Panhematin treatment arm
1137748|NCT00467610|O1|Outcome|Group 1|Panhematin treatment arm
1137749|NCT00467610|E1|Reported Event|Group 1|Panhematin treatment arm
1137750|NCT00467597|B5|Baseline|Total|Total of all reporting groups
1137751|NCT00467597|B4|Baseline|Controls - No PD|Controls with no Parkinson's disease
1137752|NCT00467597|B3|Baseline|PD - Mod LID|Parkinson's disease with moderate to severe levodopa-induced dyskinesia (mAIMS > 8)
1137753|NCT00467597|B2|Baseline|PD - Mild LID|Parkinson's disease with mild to moderate levodopa-induced dyskinesia (mAIMS <= 7)
1137754|NCT00467597|B1|Baseline|PD - No LID|Parkinson's disease without levodopa-induced dyskinesia
1137755|NCT00467597|P2|Participant Flow|Controls|Non-Parkinson's Disease Controls (no intervention).
1137756|NCT00467597|P1|Participant Flow|Parkinson's Disease|Parkinson's disease with and without Levodopa-Induced Dyskinesia (no intervention).
1137757|NCT00467597|O4|Outcome|Controls - No PD|Controls with no Parkinson's disease
1137758|NCT00467597|O3|Outcome|PD - Mod LID|Parkinson's disease with moderate to severe levodopa-induced dyskinesia (mAIMS > 8)
1137759|NCT00467597|O2|Outcome|PD - Mild LID|Parkinson's disease with mild to moderate levodopa-induced dyskinesia (mAIMS <= 7)
1137760|NCT00467597|O1|Outcome|PD - No LID|Parkinson's disease without levodopa-induced dyskinesia
1137761|NCT00467597|E4|Reported Event|Controls - No PD|Controls with no Parkinson's disease
1137762|NCT00467597|E3|Reported Event|PD - Mod LID|Parkinson's disease with moderate to severe levodopa-induced dyskinesia (mAIMS > 8)
1140901|NCT00460239|O2|Outcome|Morphine 15 mg|
1137763|NCT00467597|E2|Reported Event|PD - Mild LID|Parkinson's disease with mild to moderate levodopa-induced dyskinesia (mAIMS <= 7)
1137764|NCT00467597|E1|Reported Event|PD - No LID|Parkinson's disease without levodopa-induced dyskinesia
1137765|NCT00467584|B4|Baseline|Total|Total of all reporting groups
1137766|NCT00467584|B3|Baseline|Placebo|Placebo tablets, matching the active aspirin tablets in appearance, taken by mouth twice per day for 8 weeks
1137767|NCT00467584|B2|Baseline|Low Dose Aspirin|Low Dose Aspirin; 162 milligrams of aspirin per day taken by mouth as two tablets, twice per day for 8 weeks
1137768|NCT00467584|B1|Baseline|High Dose Aspirin|High Dose Aspirin; 1300 milligrams of aspirin per day, taken by mouth as two tablets, twice per day for 8 weeks
1137769|NCT00467584|P3|Participant Flow|Placebo|"Placebo tablets, matching the active aspirin tablets in appearance, taken by mouth twice per day for 8 weeks~Placebo: Placebo tablets matching the active aspirin tablets in appearance, taken as two tablets, twice per day for 8 weeks"
1137770|NCT00467584|P2|Participant Flow|Low Dose Aspirin|"Low Dose Aspirin; 162 milligrams of aspirin per day (the equivalent of 2 baby aspirin tablets) taken by mouth as two tablets, twice a day in the morning and at noon for 8 weeks~Low Dose Aspirin (162 mg/day): 162 milligrams per day (the equivalent of 2 baby aspirin tablets) taken by mouth as two tablets, twice a day in the morning and at noon for 8 weeks"
1137771|NCT00467584|P1|Participant Flow|High Dose Aspirin|"High Dose Aspirin; 1300 milligrams of aspirin per day, taken by mouth as two tablets, twice per day for 8 weeks~High Dose Aspirin (1300 mg/day): 1300 milligrams per day (the equivalent of 4 regular aspirin tablets) taken by mouth as two tablets, twice a day in the morning and at noon for 8 weeks"
1137772|NCT00467584|O3|Outcome|Placebo|Placebo tablets, matching the active aspirin tablets in appearance, taken by mouth twice per day for 8 weeks
1137773|NCT00467584|O2|Outcome|Low Dose Aspirin|Low Dose Aspirin; 162 milligrams of aspirin per day taken by mouth as two tablets, twice per day for 8 weeks
1137774|NCT00467584|O1|Outcome|High Dose Aspirin|High Dose Aspirin; 1300 milligrams of aspirin per day, taken by mouth as two tablets, twice per day for 8 weeks
1137775|NCT00467584|E3|Reported Event|Placebo|Placebo tablets, matching the active aspirin tablets in appearance, taken by mouth twice per day for 8 weeks
1137776|NCT00467584|E2|Reported Event|Low Dose Aspirin|Low Dose Aspirin; 162 milligrams of aspirin per day taken by mouth as two tablets, twice per day for 8 weeks
1137777|NCT00467584|E1|Reported Event|High Dose Aspirin|High Dose Aspirin; 1300 milligrams of aspirin per day, taken by mouth as two tablets, twice per day for 8 weeks
1137778|NCT00467558|B3|Baseline|Total|Total of all reporting groups
1137779|NCT00467558|B2|Baseline|Placebo|Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
1137780|NCT00467558|B1|Baseline|Naltrexone|Naltrexone 50mg-150mg by mouth per day.
1137781|NCT00467558|P2|Participant Flow|Placebo|Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
1137782|NCT00467558|P1|Participant Flow|Naltrexone|Naltrexone 50mg-150mg by mouth per day.
1137783|NCT00467558|O2|Outcome|Placebo|Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
1137784|NCT00467558|O1|Outcome|Naltrexone|Naltrexone 50mg-150mg by mouth per day.
1137785|NCT00467558|O2|Outcome|Placebo|Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
1137786|NCT00467558|O1|Outcome|Naltrexone|Naltrexone 50mg-150mg by mouth per day.
1137787|NCT00467558|E2|Reported Event|Placebo|Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
1137788|NCT00467558|E1|Reported Event|Naltrexone|Naltrexone 50mg-150mg by mouth per day.
1137789|NCT00467519|B3|Baseline|Total|Total of all reporting groups
1137790|NCT00467519|B2|Baseline|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
1137791|NCT00467519|B1|Baseline|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
1137792|NCT00467519|P2|Participant Flow|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
1137793|NCT00467519|P1|Participant Flow|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
1137794|NCT00467519|O2|Outcome|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
1137795|NCT00467519|O1|Outcome|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
1137796|NCT00467519|O2|Outcome|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
1137797|NCT00467519|O1|Outcome|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
1137798|NCT00467519|O2|Outcome|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
1137799|NCT00467519|O1|Outcome|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
1137800|NCT00467519|O2|Outcome|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
1137801|NCT00467519|O1|Outcome|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
1138441|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1137802|NCT00467519|O2|Outcome|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
1137803|NCT00467519|O1|Outcome|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
1137804|NCT00467519|O2|Outcome|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
1137805|NCT00467519|O1|Outcome|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
1137806|NCT00467519|E2|Reported Event|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
1137807|NCT00467519|E1|Reported Event|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
1137808|NCT00467389|B1|Baseline|All Participants|All recruited subjects
1137809|NCT00467389|P2|Participant Flow|Donepezil Treatment First|Participants initially treated with oral donepezil, and later treated with oral placebo
1137810|NCT00467389|P1|Participant Flow|Placebo Treatment First|Participants initially treated with oral placebo, and later treated with oral donepezil
1137811|NCT00467389|O2|Outcome|Donepezil Treatment Period|Active Treatment
1137812|NCT00467389|O1|Outcome|Placebo Treatment Period|Inactive Comparator
1137813|NCT00467389|O2|Outcome|Donepezil Treatment Period|Active Treatment
1137814|NCT00467389|O1|Outcome|Placebo Treatment Period|Inactive Comparator
1137815|NCT00467389|O2|Outcome|Donepezil Treatment Period|Active Treatment
1137816|NCT00467389|O1|Outcome|Placebo Treatment Period|Inactive Comparator
1137817|NCT00467389|E2|Reported Event|Donepezil Treatment Period|Active Treatment
1137818|NCT00467389|E1|Reported Event|Placebo Treatment Period|Inactive Comparator.
1137819|NCT00467363|B3|Baseline|Total|Total of all reporting groups
1137820|NCT00467363|B2|Baseline|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
1137821|NCT00467363|B1|Baseline|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
1137822|NCT00467363|P2|Participant Flow|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
1137823|NCT00467363|P1|Participant Flow|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
1137824|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
1137825|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
1137826|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
1137827|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
1137828|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
1138546|NCT00465101|O3|Outcome|6 Months|
1137829|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
1137830|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
1137831|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
1137832|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
1137833|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
1137834|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
1137835|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
1137836|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
1137837|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
1137838|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
1137839|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
1137840|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
1137841|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
1137842|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
1137843|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
1137844|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
1137845|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
1137846|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
1137847|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
1137848|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
1137849|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
1137850|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
1137851|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
1137852|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
1137853|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
1137854|NCT00467363|E2|Reported Event|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
1137855|NCT00467363|E1|Reported Event|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
1137856|NCT00467285|B3|Baseline|Total|Total of all reporting groups
1137857|NCT00467285|B2|Baseline|No Pioglitazone|64 subjects with type 2 diabetes not on pioglitazone, less than 55 years old.
1137858|NCT00467285|B1|Baseline|Pioglitazone|32 subjects with type 2 diabetes on pioglitazone.
1137859|NCT00467285|P2|Participant Flow|Group 2|64 subjects with type 2 diabetes not on pioglitazone, less than 55 years old.
1137860|NCT00467285|P1|Participant Flow|Group 1|32 subjects with type 2 diabetes on pioglitazone.
1137861|NCT00467285|O2|Outcome|No Pioglitazone|64 subjects with type 2 diabetes not on pioglitazone
1137862|NCT00467285|O1|Outcome|Piogliazone|32 Subjects with type 2 diabetes on Pioglitazone
1137863|NCT00467285|O2|Outcome|No Pioglitazone|64 subjects with type 2 diabetes not on pioglitazone
1137864|NCT00467285|O1|Outcome|Piogliazone|32 Subjects with type 2 diabetes on Pioglitazone
1137865|NCT00467285|O2|Outcome|No Pioglitazone|64 subjects with type 2 diabetes not on pioglitazone
1137866|NCT00467285|O1|Outcome|Piogliazone|32 Subjects with type 2 diabetes on Pioglitazone
1137867|NCT00467285|O2|Outcome|No Pioglitazone|64 subjects with type 2 diabetes not on pioglitazone
1137868|NCT00467285|O1|Outcome|Piogliazone|32 Subjects with type 2 diabetes on Pioglitazone
1137869|NCT00467285|O2|Outcome|No Pioglitazone|64 subjects with type 2 diabetes not on pioglitazone
1137870|NCT00467285|O1|Outcome|Piogliazone|32 Subjects with type 2 diabetes on Pioglitazone
1137871|NCT00467285|O2|Outcome|Baseline Characteristics: Group 2|Mean age of 49 with mean BMI 0f 35.2 ± 5; HbA1C of 7.45
1137872|NCT00467285|O1|Outcome|Baseline Characteristics: Group 1|Mean age of 49 with mean BMI 0f 33.6 ± 5; HbA1C of 7.54
1137873|NCT00467285|O2|Outcome|No Pioglitazone|64 subjects with type 2 diabetes not on pioglitazone
1137874|NCT00467285|O1|Outcome|Piogliazone|32 Subjects with type 2 diabetes on Pioglitazone
1137875|NCT00467285|E2|Reported Event|No Pioglitazone|Subjects not on pioglitazone
1137876|NCT00467285|E1|Reported Event|Pioglitazone|Subjects on pioglitazone
1137877|NCT00467259|B3|Baseline|Total|Total of all reporting groups
1137878|NCT00467259|B2|Baseline|Testosterone|Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
1137879|NCT00467259|B1|Baseline|Placebo|Placebo patch
1137880|NCT00467259|P2|Participant Flow|Testosterone|Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
1137881|NCT00467259|P1|Participant Flow|Placebo|Placebo patch
1138547|NCT00465101|O2|Outcome|3 Months|
1137884|NCT00467259|O2|Outcome|Testosterone|Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
1137885|NCT00467259|O1|Outcome|Placebo|Placebo patch
1137886|NCT00467259|O2|Outcome|Testosterone|Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
1137887|NCT00467259|O1|Outcome|Placebo|Placebo patch
1137888|NCT00467259|E2|Reported Event|Testosterone|Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
1137889|NCT00467259|E1|Reported Event|Placebo|Placebo patch
1137890|NCT00467077|B1|Baseline|Gefitinib and PEG-IFNa Treatment|Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
1137891|NCT00467077|P1|Participant Flow|Gefitinib and PEG-IFNa Treatment|Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
1137892|NCT00467077|O1|Outcome|Gefitinib and PEG-IFNa Treatment|Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
1137893|NCT00467077|O1|Outcome|Gefitinib and PEG-IFNa Treatment|Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
1137894|NCT00467077|O1|Outcome|Gefitinib and PEG-IFNa Treatment|Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
1137895|NCT00467077|O1|Outcome|Gefitinib and PEG-IFNa Treatment|Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
1137896|NCT00467077|E1|Reported Event|Arm 1|Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
1137916|NCT00466947|P1|Participant Flow|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1138442|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1137897|NCT00467051|B1|Baseline|Treatment (Chemotherapy, Biological Therapy)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV dosage 135 mg/m2/dose~carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x [(0.93 x GFR mL/min/m2) + 15]= 6.5 x [(0.93 x GFR mL/min/m2) + 15]. (BSA = body surface area in square meters). GFR is reported in institutions as uncorrected or raw (not normalized to BSA) or corrected. This number needs to be converted to GFR in mL/min/m2.~ifosfamide: Given IV dosage 1800 mg/m2/dose~filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2~laboratory biomarker analysis: Optional correlative studies"
1137898|NCT00467051|P1|Participant Flow|Treatment (Chemotherapy, Biological Therapy)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV dosage 135 mg/m2/dose~carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x [(0.93 x GFR mL/min/m2) + 15]= 6.5 x [(0.93 x GFR mL/min/m2) + 15]. (BSA = body surface area in square meters). GFR is reported in institutions as uncorrected or raw (not normalized to BSA) or corrected. This number needs to be converted to GFR in mL/min/m2.~ifosfamide: Given IV dosage 1800 mg/m2/dose~filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2~laboratory biomarker analysis: Optional correlative studies"
1137899|NCT00467051|O1|Outcome|Treatment (Chemotherapy, Biological Therapy)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV dosage 135 mg/m2/dose~carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x [(0.93 x GFR mL/min/m2) + 15]= 6.5 x [(0.93 x GFR mL/min/m2) + 15]. (BSA = body surface area in square meters). GFR is reported in institutions as uncorrected or raw (not normalized to BSA) or corrected. This number needs to be converted to GFR in mL/min/m2.~ifosfamide: Given IV dosage 1800 mg/m2/dose~filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2~laboratory biomarker analysis: Optional correlative studies"
1137900|NCT00467051|E1|Reported Event|Treatment (Chemotherapy, Biological Therapy)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV dosage 135 mg/m2/dose~carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x [(0.93 x GFR mL/min/m2) + 15]= 6.5 x [(0.93 x GFR mL/min/m2) + 15]. (BSA = body surface area in square meters). GFR is reported in institutions as uncorrected or raw (not normalized to BSA) or corrected. This number needs to be converted to GFR in mL/min/m2.~ifosfamide: Given IV dosage 1800 mg/m2/dose~filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2~laboratory biomarker analysis: Optional correlative studies"
1137901|NCT00467038|B3|Baseline|Total|Total of all reporting groups
1137902|NCT00467038|B2|Baseline|Healthy Controls|"Healthy controls~Age and gender matched healthy volunteers"
1137929|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137903|NCT00467038|B1|Baseline|Dialectical Behavior Therapy|"Dialectical Behavior Therapy~Dialectical Behavior: Dialectical Behavior Therapy is an empirically validated treatment approach emphasizing the role of emotion regulation in the treatment of suicidal and self-destructive behaviors in BPD~Event-related fMRI was obtained pre- and post-12-months of standard-DBT in unmedicatedBPD patients."
1137904|NCT00467038|P2|Participant Flow|Healthy Controls|Healthy controls- no intervention
1137905|NCT00467038|P1|Participant Flow|Dialectical Behavior Therapy|Participants receiving Dialectical Behavior Therapy
1137906|NCT00467038|O2|Outcome|Healthy Controls|Healthy controls age- and gender-matched to other group of participants
1137907|NCT00467038|O1|Outcome|Dialectical Behavior Therapy|Dialectical Behavior Therapy is an empirically validated treatment approach emphasizing the role of emotion regulation in the treatment of suicidal and self-destructive behaviors in BPD
1137908|NCT00467038|O2|Outcome|Healthy Controls|Healthy controls age- and gender-matched to other group of participants
1137909|NCT00467038|O1|Outcome|Dialectical Behavior Therapy|"Dialectical Behavior Therapy~Dialectical Behavior: Dialectical Behavior Therapy is an empirically validated treatment approach emphasizing the role of emotion regulation in the treatment of suicidal and self-destructive behaviors in BPD"
1137910|NCT00467038|E2|Reported Event|Arm 2|Healthy controls- no intervention
1137911|NCT00467038|E1|Reported Event|Arm 1|"Dialectical Behavior Therapy~Dialectical Behavior: Dialectical Behavior Therapy is an empirically validated treatment approach emphasizing the role of emotion regulation in the treatment of suicidal and self-destructive behaviors in BPD"
1137912|NCT00466947|B3|Baseline|Total|Total of all reporting groups
1137913|NCT00466947|B2|Baseline|Control Group|Subjects received 3 doses of Engerix at 2,4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccine were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137914|NCT00466947|B1|Baseline|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137915|NCT00466947|P2|Participant Flow|Control Group|Subjects received 3 doses of Engerix at 2,4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccine were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137917|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137918|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137919|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137920|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137921|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137922|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137923|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137924|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137925|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137926|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137927|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137928|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137930|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137931|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137932|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137933|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137934|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137935|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137936|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137937|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137938|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137939|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137940|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137941|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137942|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137943|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137944|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137945|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137946|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137947|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137948|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137949|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1138548|NCT00465101|O1|Outcome|Baseline|
1137950|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137951|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137952|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137953|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137954|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137955|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137956|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137957|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137958|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137959|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137960|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137961|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137962|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137963|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137964|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137965|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137966|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137967|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137968|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137969|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137970|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137971|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137972|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137973|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137974|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137975|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137976|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137977|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137978|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137979|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137980|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137981|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137982|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137983|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137984|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137985|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137986|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137987|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137988|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137989|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137990|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137991|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137992|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137993|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137994|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137995|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137996|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137997|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1137998|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1137999|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1138000|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1138001|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1138002|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1138003|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1138004|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1138005|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1138006|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1138007|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1138008|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1138009|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1138010|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1138011|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1138012|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1138013|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1138014|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1138015|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1138016|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1138017|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1138018|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1138019|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1138020|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1138021|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1138022|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1138023|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1138024|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1138025|NCT00466947|O1|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1138026|NCT00466947|O1|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1138027|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1138028|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1138029|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1138030|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1138031|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1138032|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1138033|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1138034|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1138035|NCT00466947|E2|Reported Event|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
1138036|NCT00466947|E1|Reported Event|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
1138037|NCT00466882|B1|Baseline|Group 1 Inamed Lap-Band System|The LAPBAND is positioned laparoscopically around the stomach and requires an overnight hospitalization and an upper GI swallow the next morning. The device can be gradually adjusted to increase stomach constriction by the physician in an office setting so that the patient loses approximately 1-2 pounds per week over two years.
1138038|NCT00466882|P1|Participant Flow|Group 1 Inamed Lap-Band System|The LAPBAND is positioned laparoscopically around the stomach and requires an overnight hospitalization and an upper GI swallow the next morning. The device can be gradually adjusted to increase stomach constriction by the physician in an office setting so that the patient loses approximately 1-2 pounds per week over two years.
1138039|NCT00466882|O1|Outcome|Group 1|The LAPBAND is positioned laparoscopically around the stomach and requires an overnight hospitalization and an upper GI swallow the next morning. The device can be gradually adjusted to increase stomach constriction by the physician in an office setting so that the patient loses approximately 1-2 pounds per week over two years.
1138040|NCT00466882|E1|Reported Event|Group 1 Inamed Lap-Band System|The LAPBAND is positioned laparoscopically around the stomach and requires an overnight hospitalization and an upper GI swallow the next morning. The device can be gradually adjusted to increase stomach constriction by the physician in an office setting so that the patient loses approximately 1-2 pounds per week over two years.
1138041|NCT00466817|B3|Baseline|Total|Total of all reporting groups
1138042|NCT00466817|B2|Baseline|Valganciclovir: 24 Wks of Valganciclovir|"Six months (6 weeks open label, 18 weeks blinded) of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
1138043|NCT00466817|B1|Baseline|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo (18 weeks) to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
1138044|NCT00466817|P2|Participant Flow|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
1138045|NCT00466817|P1|Participant Flow|Placebo: 6 Wks Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
1138046|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
1138047|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
1138048|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
1138173|NCT00466310|E1|Reported Event|First Episode Schizophrenics|These are subjects with no prior schizophrenic episodes
1138049|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
1138050|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
1138051|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
1138052|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Vlaganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
1138053|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
1138054|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
1138055|NCT00466817|O1|Outcome|Placebo: 6 Wks Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
1138199|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
1138443|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138056|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
1138057|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
1138058|NCT00466817|O2|Outcome|Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
1138059|NCT00466817|O1|Outcome|Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
1138060|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
1138061|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
1138062|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
1138063|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
1138064|NCT00466817|O2|Outcome|Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
1138065|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
1138301|NCT00465972|P1|Participant Flow|Placebo|One sugar pill taken orally at bedtime for duration of the participant's involvement.
1138066|NCT00466817|O2|Outcome|Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
1138067|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
1138068|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
1138069|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
1138070|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
1138071|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
1138072|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
1138073|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
1138074|NCT00466817|O2|Outcome|Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
1138075|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
1138076|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
1138077|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
1138078|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
1138079|NCT00466817|O1|Outcome|Placebo: 6 Wks of Vlaganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
1138080|NCT00466817|O2|Outcome|Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
1138081|NCT00466817|O1|Outcome|Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
1138082|NCT00466817|O2|Outcome|Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
1138083|NCT00466817|O1|Outcome|Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
1138084|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
1138085|NCT00466817|O1|Outcome|Placebo: 6 Wks Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
1138086|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
1138087|NCT00466817|O1|Outcome|Placebo: 6 Wks Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
1138088|NCT00466817|O2|Outcome|Valganciclovir: 24 Weeks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
1138089|NCT00466817|O1|Outcome|Placebo: 6 Wks Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
1138090|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
1138091|NCT00466817|O1|Outcome|Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
1138092|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
1138093|NCT00466817|O1|Outcome|Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
1138094|NCT00466817|E3|Reported Event|Placebo After 6 Weeks of Valganciclovir|6 weeks of open labeled vanganciclovir followed by 4 1/2 months of blinded placebo
1138095|NCT00466817|E2|Reported Event|Active|6 weeks of open labeled vanganciclovir followed by 4 1/2 months of blinded valganciclovir
1138096|NCT00466817|E1|Reported Event|Non Randomized|6 weeks of open label valganciclovir only
1138097|NCT00466687|B1|Baseline|Therapeutic Intervention|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
1138098|NCT00466687|P1|Participant Flow|Therapeutic Intervention|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
1138099|NCT00466687|O1|Outcome|Tarceva/Avastin|Study drugs are administered on a 28-day cycle: Tarceva 150 mg by mouth per day and Avastin 10 mg/kg of body weight intravenously (IV) on days 1 and 15.
1138100|NCT00466687|O1|Outcome|Therapeutic Intervention|Study drugs are administered on a 28-day cycle: Tarceva 150 mg by mouth per day and Avastin 10 mg/kg of body weight intravenously (IV) on days 1 and 15.
1138101|NCT00466687|O1|Outcome|Tarceva/Avastin|Study drugs are administered on a 28-day cycle for 6 cycles: Tarceva 150 mg by mouth per day and Avastin 10 mg/kg of body weight intravenously (IV) on days 1 and 15.
1138102|NCT00466687|O1|Outcome|Tarceva/Avastin|Study drugs are administered on a 28-day cycle for 6 cycles: Tarceva 150 mg by mouth per day and Avastin 10 mg/kg of body weight intravenously (IV) on days 1 and 15.
1138103|NCT00466687|E1|Reported Event|Therapeutic Intervention|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
1138104|NCT00465647|B5|Baseline|Total|Total of all reporting groups
1138105|NCT00465647|B4|Baseline|≥ 12 Years to < 17 Years|Adolescent - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
1138106|NCT00465647|B3|Baseline|≥ 5 Years to < 12 Years|Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
1138107|NCT00465647|B2|Baseline|≥ 13 Months to < 5 Years|Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
1138549|NCT00465101|O2|Outcome|Delayed (15-91 Days)|
1138108|NCT00465647|B1|Baseline|≥ 28 Days to < 13 Months|Infant and toddler - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
1138109|NCT00465647|P4|Participant Flow|≥ 12 Years to < 17 Years|Adolescent- received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
1138110|NCT00465647|P3|Participant Flow|≥ 5 Years to <12 Years|Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
1138111|NCT00465647|P2|Participant Flow|≥ 13 Months to < 5 Years|Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
1138112|NCT00465647|P1|Participant Flow|≥ 28 Days to < 13 Months|Infant and toddler - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
1138113|NCT00465647|O4|Outcome|Oral ≥ 12 Years to < 17 Years|Adolescent - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
1138114|NCT00465647|O3|Outcome|Oral ≥ 5 Years to <12 Years|Older child (Data for this group not collected. Test not appropriate for this age)
1138115|NCT00465647|O2|Outcome|Oral ≥ 13 Months to < 5 Years|Young child (Data for this group not collected. Test not appropriate for this age)
1138116|NCT00465647|O1|Outcome|Oral ≥ 28 Days to < 13 Months|Infant and toddler (Data for this group not collected. Test not appropriate for this age)
1138117|NCT00465647|O4|Outcome|Oral ≥ 12 Years to < 17 Years|Adolescent (Data for this group not collected. Test not appropriate for this age)
1138118|NCT00465647|O3|Outcome|Oral ≥ 5 Years to <12 Years|Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
1138119|NCT00465647|O2|Outcome|Oral ≥ 13 Months to < 5 Years|Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
1138120|NCT00465647|O1|Outcome|Oral ≥ 28 Days to < 13 Months|Infant and toddler (Data for this group not collected. Test not appropriate for this age)
1138121|NCT00465647|O4|Outcome|Oral ≥ 12 Years to < 17 Years|Adolescent (Data for this group not collected. Test not appropriate for this age)
1138122|NCT00465647|O3|Outcome|Oral ≥ 5 Years to < 12 Years|Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
1138444|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138123|NCT00465647|O2|Outcome|Oral ≥ 13 Months to < 5 Years|Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
1138124|NCT00465647|O1|Outcome|Oral ≥ 28 Days to < 13 Months|Infant and toddler - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
1138125|NCT00465647|O1|Outcome|All Patients|A total of all 4 age groups: infant and toddler, young child, older child, and adolescent.
1138126|NCT00465647|E8|Reported Event|Parenteral ≥ 12 Years to < 17 Years|Adolescent - received parenteral analgesia up to 48 hours postsurgery.
1138127|NCT00465647|E7|Reported Event|Parenteral ≥ 5 Years to < 12 Years|Older child - received parenteral analgesia up to 48 hours postsurgery.
1138128|NCT00465647|E6|Reported Event|Parenteral ≥ 13 Months to < 5 Years|Young child - received parenteral analgesia up to 48 hours postsurgery.
1138129|NCT00465647|E5|Reported Event|Parenteral ≥ 28 Days to < 13 Months|Infant and toddler - received parenteral analgesia up to 48 hours postsurgery.
1138130|NCT00465647|E4|Reported Event|Oral ≥ 12 Years to < 17 Years|Adolescent - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
1138131|NCT00465647|E3|Reported Event|Oral ≥ 5 Years to <12 Years|Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
1138132|NCT00465647|E2|Reported Event|Oral ≥ 13 Months to < 5 Years|Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
1138133|NCT00465647|E1|Reported Event|Oral ≥ 28 Days to < 13 Months|Infant and toddler - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
1138134|NCT00466505|B1|Baseline|Therapeutic Intervention|
1138135|NCT00466505|P1|Participant Flow|Therapeutic Intervention|
1138136|NCT00466505|O1|Outcome|Therapeutic Intervention|
1138137|NCT00466505|O1|Outcome|Therapeutic Intervention|
1138138|NCT00466505|O1|Outcome|Therapeutic Intervention|
1138139|NCT00466505|O1|Outcome|Therapeutic Intervention|
1138140|NCT00466505|O1|Outcome|Therapeutic Intervention|
1138141|NCT00466505|O1|Outcome|Therapeutic Intervention|
1138142|NCT00466505|O1|Outcome|Therapeutic Intervention|
1138143|NCT00466505|O1|Outcome|Therapeutic Intervention|
1138144|NCT00466505|O1|Outcome|Therapeutic Intervention|
1138145|NCT00466505|E1|Reported Event|Therapeutic Intervention|
1138146|NCT00466323|B3|Baseline|Total|Total of all reporting groups
1138147|NCT00466323|B2|Baseline|Enhanced Treatment as Usual (e-TAU)|"Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.~Enhanced treatment as usual (e-TAU): Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team."
1138174|NCT00466206|B1|Baseline|3MP Treatment Arm|Undergo active Magnetic Mini-Mover Procedure for treatment of pectus excavatum. Active treatment = 18 months
1138148|NCT00466323|B1|Baseline|FMPO Condition|"Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.~Family Member Provider Outreach: Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission."
1138149|NCT00466323|P2|Participant Flow|Enhanced Treatment as Usual (e-TAU)|"Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.~Enhanced treatment as usual (e-TAU): Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team."
1138150|NCT00466323|P1|Participant Flow|FMPO Condition|"Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.~Family Member Provider Outreach: Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission."
1138151|NCT00466323|O2|Outcome|Enhanced Treatment as Usual (e-TAU)|"Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.~Enhanced treatment as usual (e-TAU): Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team."
1138152|NCT00466323|O1|Outcome|FMPO Condition|"Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.~Family Member Provider Outreach: Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission."
1138153|NCT00466323|O2|Outcome|Enhanced Treatment as Usual (e-TAU)|"Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.~Enhanced treatment as usual (e-TAU): Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team."
1138154|NCT00466323|O1|Outcome|FMPO Condition|"Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.~Family Member Provider Outreach: Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission."
1138155|NCT00466323|O2|Outcome|Enhanced Treatment as Usual (e-TAU)|"Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.~Enhanced treatment as usual (e-TAU): Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team."
1138200|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
1138201|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
1138156|NCT00466323|O1|Outcome|FMPO Condition|"Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.~Family Member Provider Outreach: Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission."
1138157|NCT00466323|O2|Outcome|Enhanced Treatment as Usual (e-TAU)|"Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.~Enhanced treatment as usual (e-TAU): Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team."
1138158|NCT00466323|O1|Outcome|FMPO Condition|"Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.~Family Member Provider Outreach: Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission."
1138159|NCT00466323|E2|Reported Event|Enhanced Treatment as Usual (e-TAU)|"Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.~Enhanced treatment as usual (e-TAU): Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team."
1138160|NCT00466323|E1|Reported Event|FMPO Condition|"Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.~Family Member Provider Outreach: Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission."
1138161|NCT00466310|B4|Baseline|Total|Total of all reporting groups
1138162|NCT00466310|B3|Baseline|Healthy Volunteers|Fasting blood samples were drawn at baseline from 31 healthy matched controls.
1138163|NCT00466310|B2|Baseline|Recurrent Episode Schizophrenics|These subjects have had at least one prior schizophrenic episode.
1138164|NCT00466310|B1|Baseline|First Episode Schizophrenics|These are subjects with no prior schizophrenic episodes
1138165|NCT00466310|P3|Participant Flow|Healthy Volunteers|Fasting blood samples were drawn at baseline from 31 healthy matched controls.
1138166|NCT00466310|P2|Participant Flow|Recurrent Episode Schizophrenics|Schizophrenia subjects with at least one prior episode
1138167|NCT00466310|P1|Participant Flow|First Episode Schizophrenics|Schizophrenia subjects with no prior episodes
1138168|NCT00466310|O3|Outcome|Healthy Volunteers|Fasting blood samples were drawn at baseline from 31 healthy matched controls.
1138169|NCT00466310|O2|Outcome|Recurrent Episode Schizophrenics|Schizophrenia subjects with at least one prior episode
1138170|NCT00466310|O1|Outcome|First Episode Schizophrenics|Schizophrenia subjects with no prior episodes
1138171|NCT00466310|E3|Reported Event|Healthy Volunteers|Fasting blood samples were drawn at baseline from 31 healthy matched controls.
1138172|NCT00466310|E2|Reported Event|Recurrent Episode Schizophrenics|These subjects have had at least one prior schizophrenic episode.
1138175|NCT00466206|P1|Participant Flow|3MP Treatment Arm|Undergo active Magnetic Mini-Mover Procedure for treatment of pectus excavatum. Active treatment = 18 months
1138176|NCT00466206|O1|Outcome|Magnetic Mini-Mover Group|Treatment for pectus excavatum using Magnimplant and Magnatract
1138177|NCT00466206|O1|Outcome|3MP Treatment Arm|Pectus excavatum treated with Magnetic Mini-Mover Procedure. Active treatment = 18 months
1138178|NCT00466206|O1|Outcome|3MP Treatment Group|Treatment of pectus excavatum with the Magnetic Mini-Mover Procedure
1138179|NCT00466206|O1|Outcome|Treatment Arm|Magnetic Mini-Mover Procedure
1138180|NCT00466206|O1|Outcome|Magnetic Mini-Mover Group|Treatment for pectus excavatum using Magnimplant and Magnatract
1138181|NCT00466206|E1|Reported Event|Magnetic Mini-Mover Treatment|Use of the Magnimplant and Magnatract to treat pectus excavatum
1138182|NCT00466193|B3|Baseline|Total|Total of all reporting groups
1138183|NCT00466193|B2|Baseline|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
1138184|NCT00466193|B1|Baseline|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
1138185|NCT00466193|P2|Participant Flow|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
1138186|NCT00466193|P1|Participant Flow|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
1138187|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
1138188|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
1138189|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
1138190|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
1138191|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
1138192|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
1138193|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
1138194|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
1138195|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
1138196|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
1138197|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
1138198|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
1138202|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
1138203|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
1138204|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
1138205|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
1138206|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
1138207|NCT00466193|E2|Reported Event|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
1138208|NCT00466193|E1|Reported Event|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
1138209|NCT00466167|B4|Baseline|Total|Total of all reporting groups
1138210|NCT00466167|B3|Baseline|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
1138211|NCT00466167|B2|Baseline|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
1138212|NCT00466167|B1|Baseline|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
1138213|NCT00466167|P3|Participant Flow|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
1138214|NCT00466167|P2|Participant Flow|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
1138215|NCT00466167|P1|Participant Flow|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
1138216|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
1138217|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
1138300|NCT00465972|P2|Participant Flow|Temazepam|One 15 mg temazepam pill taken orally at bedtime for the duration of the participant's involvement.
1138218|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
1138219|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
1138220|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
1138221|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
1138222|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
1138223|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
1138224|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
1138225|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
1138226|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
1138227|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
1138273|NCT00465998|O1|Outcome|Successful Vaginal Delivery|"275 women with induced labors were included in the study, and the main outcome was vaginal delivery.~Variables associated to a successful vaginal delivery was examined."
1138228|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
1138229|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
1138230|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
1138231|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
1138232|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
1138233|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
1138234|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
1138235|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
1138236|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
1138237|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
1138238|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
1138302|NCT00465972|O2|Outcome|Temazepam|1 15 mg pill taken nightly at bedtime.
1138239|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
1138240|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
1138241|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
1138242|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
1138243|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
1138244|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
1138245|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
1138246|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
1138247|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
1138248|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
1138271|NCT00465998|P1|Participant Flow|Successful Vaginal Delivery|"275 women with induced labors were included in the study, and the main outcome was vaginal delivery.~Variables associated to a successful vaginal delivery was examined."
1138379|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
1138249|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
1138250|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
1138251|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
1138252|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
1138253|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
1138254|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
1138255|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
1138256|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
1138257|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
1138258|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
1138259|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
1138260|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
1138261|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
1138262|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
1138263|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
1138264|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
1138265|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
1138266|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
1138267|NCT00466167|E3|Reported Event|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
1138268|NCT00466167|E2|Reported Event|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
1138269|NCT00466167|E1|Reported Event|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
1138270|NCT00465998|B1|Baseline|Time From Induction to Delivery|Variables associated to time from induction to delivery were investigated.
1138272|NCT00465998|O1|Outcome|Time From Induction to Delivery|Variables associated to time from induction to delivery were investigated.
1138274|NCT00465998|E1|Reported Event|Successful Vaginal Delivery|"275 women with induced labors were included in the study, and the main outcome was vaginal delivery.~Variables associated to a successful vaginal delivery was examined."
1138275|NCT00465985|B1|Baseline|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
1138276|NCT00465985|P2|Participant Flow|Placebo|Placebo subcutaneous injection every 8 weeks.
1138277|NCT00465985|P1|Participant Flow|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
1138278|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
1138279|NCT00465985|O2|Outcome|Placebo|Placebo subcutaneous injection every 8 weeks.
1138280|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
1138281|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
1138282|NCT00465985|O2|Outcome|Placebo|Placebo subcutaneous injection every 8 weeks.
1138283|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
1138284|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
1138285|NCT00465985|O2|Outcome|Placebo|Placebo subcutaneous injection every 8 weeks.
1138286|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
1138287|NCT00465985|O2|Outcome|Placebo|Placebo subcutaneous injection every 8 weeks.
1138288|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
1138289|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
1138290|NCT00465985|O2|Outcome|Placebo|Placebo subcutaneous injection every 8 weeks.
1138291|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
1138292|NCT00465985|E5|Reported Event|Entire Study ACZ885|Entire study ACZ885. The SAE and AEs were collected and reported for all three periods.
1138293|NCT00465985|E4|Reported Event|Part III ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
1138294|NCT00465985|E3|Reported Event|Part II Placebo|Placebo subcutaneous injection every 8 weeks.
1138295|NCT00465985|E2|Reported Event|Part II ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
1138296|NCT00465985|E1|Reported Event|Part I ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
1138297|NCT00465972|B3|Baseline|Total|Total of all reporting groups
1138298|NCT00465972|B2|Baseline|Temazepam|1 15 mg pill taken nightly at bedtime.
1138299|NCT00465972|B1|Baseline|Placebo|1 sugar pill taken nightly at bedtime.
1138306|NCT00465972|E2|Reported Event|Temazepam|1 15 mg pill taken orally, nightly, at bedtime.
1138307|NCT00465972|E1|Reported Event|Placebo|1 sugar pill taken nightly at bedtime.
1138308|NCT00465894|B3|Baseline|Total|Total of all reporting groups
1138309|NCT00465894|B2|Baseline|Group 2: Intra Vaginal Estradiol Cream|0.5 grams of Intra vaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
1138310|NCT00465894|B1|Baseline|Group 1: Extended Release Tolterodine|4 mg Tolterodine po daily for 12 weeks
1138311|NCT00465894|P2|Participant Flow|Group 2: Intra Vaginal Estradiol Cream|0.5 grams of Intra vaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
1138312|NCT00465894|P1|Participant Flow|Group 1: Extended Release Tolterodine|4 mg Tolterodine po daily for 12 weeks
1138313|NCT00465894|O2|Outcome|Group 2: Intra Vaginal Estradiol Cream|0.5 grams of Intra vaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
1138314|NCT00465894|O1|Outcome|Group 1: Extended Release Tolterodine|4 mg Tolterodine po daily for 12 weeks
1138315|NCT00465894|E2|Reported Event|Group 2: Intra Vaginal Estradiol Cream|0.5 grams of Intra vaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
1138316|NCT00465894|E1|Reported Event|Group 1: Extended Release Tolterodine|4 mg Tolterodine po daily for 12-weeks
1138317|NCT00465816|B4|Baseline|Total|Total of all reporting groups
1138318|NCT00465816|B3|Baseline|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138319|NCT00465816|B2|Baseline|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
1138320|NCT00465816|B1|Baseline|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138321|NCT00465816|P3|Participant Flow|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138322|NCT00465816|P2|Participant Flow|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
1138323|NCT00465816|P1|Participant Flow|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138324|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138325|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
1138326|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138327|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138328|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
1138329|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138330|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138331|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
1138332|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138333|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138334|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
1138335|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138336|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138337|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
1138338|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138339|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138340|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
1138341|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138342|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138343|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
1138344|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138345|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138346|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
1138347|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138348|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138349|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
1138350|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138351|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138352|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
1138353|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138354|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138355|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
1138356|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138357|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138358|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
1138359|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138360|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138361|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
1138362|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138363|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138364|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
1138365|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138366|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138367|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
1138368|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138369|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138370|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
1138371|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138372|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138373|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
1138374|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138375|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138376|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
1138377|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138378|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138380|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138381|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138382|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
1138383|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138384|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138385|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
1138386|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138387|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138388|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
1138389|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138390|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138391|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
1138392|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138393|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138394|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
1138395|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138396|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138397|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
1138398|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138399|NCT00465816|E3|Reported Event|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138400|NCT00465816|E2|Reported Event|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
1138401|NCT00465816|E1|Reported Event|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
1138402|NCT00465738|B3|Baseline|Total|Total of all reporting groups
1138403|NCT00465738|B2|Baseline|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138404|NCT00465738|B1|Baseline|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138405|NCT00465738|P2|Participant Flow|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138406|NCT00465738|P1|Participant Flow|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138407|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138408|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138409|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138410|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138411|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138412|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138413|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138414|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138415|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138416|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138417|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138418|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138419|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138420|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138421|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138422|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138423|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138424|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138425|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138426|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138427|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138428|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138429|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138430|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138431|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138432|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138433|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138434|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138435|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138436|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138437|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138438|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1140902|NCT00460239|O1|Outcome|Placebo 0 mg|
1138445|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138446|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138447|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138448|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138449|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138450|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138451|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138452|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138453|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138454|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138455|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138456|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138457|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138458|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138459|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138460|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138461|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138462|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138463|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138464|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138465|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138466|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138467|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138468|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138469|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138470|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138471|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138472|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138473|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138474|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138475|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138476|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138477|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138478|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138479|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138480|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138481|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138482|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138483|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138484|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138485|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138486|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138487|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138488|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138489|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138490|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138491|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138492|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138493|NCT00465738|E2|Reported Event|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
1138494|NCT00465738|E1|Reported Event|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
1138495|NCT00465569|B3|Baseline|Total|Total of all reporting groups
1138496|NCT00465569|B2|Baseline|Placebo|Placebo
1138497|NCT00465569|B1|Baseline|Active Treatment|"Pre-measured doses of dry, nonfat powered milk prepared by the clinical research-registered dieticians~cow's milk powder: Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks"
1138498|NCT00465569|P2|Participant Flow|Placebo|Pre-measured doses of ProFree, a dry, milk free powder
1138499|NCT00465569|P1|Participant Flow|Active Treatment|"Pre-measured doses of dry, nonfat powered milk prepared by the clinical research-registered dieticians~cow's milk powder: Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks"
1138500|NCT00465569|O2|Outcome|Placebo|Placebo
1138501|NCT00465569|O1|Outcome|Active Treatment|"Pre-measured doses of dry, nonfat powered milk prepared by the clinical research-registered dieticians~cow's milk powder: Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks"
1138502|NCT00465569|O2|Outcome|Placebo|Placebo
1138503|NCT00465569|O1|Outcome|Active Treatment|"Pre-measured doses of dry, nonfat powered milk prepared by the clinical research-registered dieticians~cow's milk powder: Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks"
1138504|NCT00465569|O2|Outcome|Placebo|Placebo
1138569|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
1140903|NCT00460239|O8|Outcome|Buprenorphine 60 mg|
1138505|NCT00465569|O1|Outcome|Active Treatment|"Pre-measured doses of dry, nonfat powered milk prepared by the clinical research-registered dieticians~cow's milk powder: Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks"
1138506|NCT00465569|E2|Reported Event|Placebo|Adverse event information is based on percentages of doses. There were 1193 total doses in the placebo arm with a median of 171 and a range of 152-199 per participant. There was a total of 7 participants in the placebo arm who were analyzed for the Adverse Events data reported below.
1138507|NCT00465569|E1|Reported Event|Active Treatment|Adverse event information is based on percentages of doses. There were 2437 total doses in the active treatment arm with a median of 177 and a range of 155-242 per participant. There was a total of 13 participants in the active treatment arm who were analyzed for the Adverse Events data reported below.
1138508|NCT00465530|B3|Baseline|Total|Total of all reporting groups
1138509|NCT00465530|B2|Baseline|Saline (Once Daily, 40 mL to Each Nostril)|
1138510|NCT00465530|B1|Baseline|Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril)|
1138511|NCT00465530|P2|Participant Flow|Saline (Once Daily, 40 mL to Each Nostril)|
1138512|NCT00465530|P1|Participant Flow|Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril)|
1138513|NCT00465530|O2|Outcome|Saline Plus Gentamicin (Once Daily, 40 mL to Each Nostril)|
1138514|NCT00465530|O1|Outcome|Saline (Once Daily, 40 mL to Each Nostril)|
1138515|NCT00465530|O2|Outcome|Saline Plus Gentamicin (Once Daily, 40 mL to Each Nostril)|
1138516|NCT00465530|O1|Outcome|Saline (Once Daily, 40 mL to Each Nostril)|
1138517|NCT00465530|O2|Outcome|Saline Plus Gentamicin (Once Daily, 40 mL to Each Nostril)|
1138518|NCT00465530|O1|Outcome|Saline (Once Daily, 40 mL to Each Nostril)|
1138519|NCT00465530|E2|Reported Event|Saline (Once Daily, 40 mL to Each Nostril)|
1138520|NCT00465530|E1|Reported Event|Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril)|
1138521|NCT00465361|B1|Baseline|Intervention|Performance after receiving feedback and educational module
1138522|NCT00465361|P1|Participant Flow|Intervention|Performance after receiving feedback and educational module
1138523|NCT00465361|O1|Outcome|Intervention|Performance after receiving feedback and educational module
1138524|NCT00465361|E1|Reported Event|Intervention|Performance after receiving feedback and educational module
1138525|NCT00465179|B1|Baseline|Sunitinib Malate|Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
1138526|NCT00465179|P1|Participant Flow|Sunitinib Malate|Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
1138527|NCT00465179|O1|Outcome|Sunitinib Malate|Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
1138528|NCT00465179|O1|Outcome|Sunitinib Malate|Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
1138529|NCT00465179|O1|Outcome|Sunitinib Malate|Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
1138530|NCT00465179|E1|Reported Event|Sunitinib Malate|Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
1138531|NCT00465101|B1|Baseline|GreenLight HPS Laser System|GreenLight HPS Laser System therapy for patients with BPH.
1138532|NCT00465101|P1|Participant Flow|GreenLight HPS Laser System|GreenLight HPS Laser System therapy for patients with BPH.
1138533|NCT00465101|O1|Outcome|Retrograde Ejaculation Occurrence Rate|
1138534|NCT00465101|O1|Outcome|Total Energy Delivered|
1138535|NCT00465101|O1|Outcome|Number of Fibers Used|
1138536|NCT00465101|O1|Outcome|Length of Lasing Time|
1138537|NCT00465101|O1|Outcome|Length of Procedure (Min)|
1138559|NCT00465101|O1|Outcome|Number of Subjects With Baseline and 6 Month Values|The total number of patients that treated equals 136; the total number of patients with Baseline and 6 month values equals 117.
1138560|NCT00465101|O1|Outcome|Number of Subjects With Baseline and 6 Month Values|The total number of patients that treated equals 136; the total number of patients with Baseline and 6 month values equals 117.
1138561|NCT00465101|O1|Outcome|Treatment Related Complication at 3 Months|
1138562|NCT00465101|O1|Outcome|GreenLight HPS Laser System|GreenLight HPS Laser System therapy for patients with BPH.
1138563|NCT00465101|E1|Reported Event|GreenLight HPS Laser System|GreenLight HPS Laser System therapy for patients with BPH.
1138564|NCT00465088|B3|Baseline|Total|Total of all reporting groups
1138565|NCT00465088|B2|Baseline|Atorvastatin|40 mg atorvastatin once daily at bedtime
1138566|NCT00465088|B1|Baseline|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
1138567|NCT00465088|P2|Participant Flow|Atorvastatin|40 mg atorvastatin once daily at bedtime
1138568|NCT00465088|P1|Participant Flow|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
1138570|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
1138571|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
1138572|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
1138573|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
1138574|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
1138575|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
1138576|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
1138577|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
1138578|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
1138579|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
1138580|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
1138581|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
1138582|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
1138583|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
1138584|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
1138585|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
1138586|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
1138587|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
1138588|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
1138589|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
1138590|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
1138591|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
1138592|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
1138593|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
1138594|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
1138595|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
1138596|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
1138597|NCT00465088|E2|Reported Event|Atorvastatin|40 mg atorvastatin once daily at bedtime
1138598|NCT00465088|E1|Reported Event|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
1138599|NCT00464945|B3|Baseline|Total|Total of all reporting groups
1138600|NCT00464945|B2|Baseline|13vPnC Pilot|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
1138601|NCT00464945|B1|Baseline|13vPnC Manufacturing|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
1138679|NCT00464737|E3|Reported Event|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
1138680|NCT00464737|E2|Reported Event|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
1138681|NCT00464737|E1|Reported Event|Placebo|Placebo
1138682|NCT00464711|B1|Baseline|Escitalopram|40 subjects met inclusion/exclusion criteria and started study treatment
1138602|NCT00464945|P2|Participant Flow|13vPnC Pilot|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
1138603|NCT00464945|P1|Participant Flow|13vPnC Manufacturing|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
1138604|NCT00464945|O2|Outcome|13vPnC Pilot|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
1138605|NCT00464945|O1|Outcome|13vPnC Manufacturing|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
1138844|NCT00464334|B11|Baseline|V950 50 mcg/IMX 16 mcg|Participants receive V950 50 mcg/IMX 16 mcg
1138606|NCT00464945|O2|Outcome|13vPnC Pilot|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
1138607|NCT00464945|O1|Outcome|13vPnC Manufacturing|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
1138608|NCT00464945|O6|Outcome|13vPnC Pilot Dose 3|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
1138609|NCT00464945|O5|Outcome|13vPnC Manufacturing Dose 3|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
1138610|NCT00464945|O4|Outcome|13vPnC Pilot Dose 2|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
1138611|NCT00464945|O3|Outcome|13vPnC Manufacturing Dose 2|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
1138612|NCT00464945|O2|Outcome|13vPnC Pilot Dose 1|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1).
1138613|NCT00464945|O1|Outcome|13vPnC Manufacturing Dose 1|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1).
1138614|NCT00464945|O8|Outcome|13vPnC Pilot Toddler Dose|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
1138615|NCT00464945|O7|Outcome|13vPnC Manufacturing Toddler Dose|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
1138616|NCT00464945|O6|Outcome|13vPnC Pilot Dose 3|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
1138617|NCT00464945|O5|Outcome|13vPnC Manufacturing Dose 3|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
1138618|NCT00464945|O4|Outcome|13vPnC Pilot Dose 2|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
1138619|NCT00464945|O3|Outcome|13vPnC Manufacturing Dose 2|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
1138620|NCT00464945|O2|Outcome|13vPnC Pilot Dose 1|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1).
1138621|NCT00464945|O1|Outcome|13vPnC Manufacturing Dose 1|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1).
1138622|NCT00464945|O2|Outcome|13vPnC Pilot|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
1138683|NCT00464711|P1|Participant Flow|Escitalopram|40 subjects met inclusion/exclusion criteria and started treatment with escitalopram
1138684|NCT00464711|O1|Outcome|Open Label Escitalopram|All subjects were treated with open label escitalopram
1138685|NCT00464711|E1|Reported Event|Escitalopram|40 subjects met inclusion/exclusion criteria and started study treatment
1138686|NCT00464698|B1|Baseline|Duloxetine|Duloxetine: Week 1 dose: 30mg, Weeks 2-4 dose: 60mg, Weeks 5-17 dose: 120mg
1142206|NCT00455650|B3|Baseline|Total|Total of all reporting groups
1138623|NCT00464945|O1|Outcome|13vPnC Manufacturing|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
1138624|NCT00464945|E6|Reported Event|13vPnC Pilot Toddler Series|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
1138625|NCT00464945|E5|Reported Event|13vPnC Manufacturing Toddler Series|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
1138626|NCT00464945|E4|Reported Event|13vPnC Pilot Post-Infant Series|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Assessment done at 5 months of age, 1 month after infant series.
1138627|NCT00464945|E3|Reported Event|13vPnC Manufacturing Post-Infant Series|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Assessment done at 5 months of age, 1 month after infant series.
1138729|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Injection 2)|Injections of the investigational influenza virus vaccine were administered intramuscularly.
1138628|NCT00464945|E2|Reported Event|13vPnC Pilot Infant Series|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
1138629|NCT00464945|E1|Reported Event|13vPnC Manufacturing Infant Series|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
1138630|NCT00464737|B4|Baseline|Total|Total of all reporting groups
1138631|NCT00464737|B3|Baseline|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
1138632|NCT00464737|B2|Baseline|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
1138633|NCT00464737|B1|Baseline|Placebo|Placebo
1138634|NCT00464737|P3|Participant Flow|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
1138635|NCT00464737|P2|Participant Flow|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
1138636|NCT00464737|P1|Participant Flow|Placebo|Placebo
1138637|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
1138638|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
1138639|NCT00464737|O1|Outcome|Placebo|Placebo
1138640|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
1138641|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
1138642|NCT00464737|O1|Outcome|Placebo|Placebo
1138643|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
1138644|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
1138645|NCT00464737|O1|Outcome|Placebo|Placebo
1138646|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
1138647|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
1138648|NCT00464737|O1|Outcome|Placebo|Placebo
1138649|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
1138650|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
1138651|NCT00464737|O1|Outcome|Placebo|Placebo
1138652|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
1138653|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
1138654|NCT00464737|O1|Outcome|Placebo|Placebo
1138655|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
1138656|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
1138657|NCT00464737|O1|Outcome|Placebo|Placebo
1138658|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
1138659|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
1138660|NCT00464737|O1|Outcome|Placebo|Placebo
1138661|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
1138662|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
1138663|NCT00464737|O1|Outcome|Placebo|Placebo
1138664|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
1138665|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
1138666|NCT00464737|O1|Outcome|Placebo|Placebo
1138667|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
1138668|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
1138669|NCT00464737|O1|Outcome|Placebo|Placebo
1138670|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
1138671|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
1138672|NCT00464737|O1|Outcome|Placebo|Placebo
1138673|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
1138687|NCT00464698|P1|Participant Flow|All Study Participants|Duloxetine Week 1 dose: 30mg Duloxetine Weeks 2-4 dose: 60mg Duloxetine Weeks 5-17 dose: 120mg
1138688|NCT00464698|O1|Outcome|Duloxetine|Duloxetine: Week 1 dose: 30mg, Weeks 2-4 dose: 60mg, Weeks 5-17 dose: 120mg
1138689|NCT00464698|O1|Outcome|Duloxetine|Duloxetine: Week 1 dose: 30mg, Weeks 2-4 dose: 60mg, Weeks 5-17 dose: 120mg
1138690|NCT00464698|O1|Outcome|Duloxetine|Duloxetine: Week 1 dose: 30mg, Weeks 2-4 dose: 60mg, Weeks 5-17 dose: 120mg
1138691|NCT00464698|O1|Outcome|Duloxetine|Duloxetine: Week 1 dose: 30mg, Weeks 2-4 dose: 60mg, Weeks 5-17 dose: 120mg
1138692|NCT00464698|O1|Outcome|Duloxetine|Duloxetine: Week 1 dose: 30mg, Weeks 2-4 dose: 60mg, Weeks 5-17 dose: 120mg
1138693|NCT00464698|E3|Reported Event|Duloxetine Weeks 5-17 Dose: 120mg|
1138694|NCT00464698|E2|Reported Event|Duloxetine Weeks 2-4 Dose: 60mg|
1138695|NCT00464698|E1|Reported Event|Duloxetine: Week 1 Dose: 30mg|
1138696|NCT00464685|B3|Baseline|Total|Total of all reporting groups
1138697|NCT00464685|B2|Baseline|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
1138698|NCT00464685|B1|Baseline|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
1138699|NCT00464685|P2|Participant Flow|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
1138700|NCT00464685|P1|Participant Flow|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
1138701|NCT00464685|O2|Outcome|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
1138702|NCT00464685|O1|Outcome|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
1138703|NCT00464685|O2|Outcome|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
1138704|NCT00464685|O1|Outcome|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
1138705|NCT00464685|O2|Outcome|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
1138706|NCT00464685|O1|Outcome|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
1138707|NCT00464685|O2|Outcome|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
1138708|NCT00464685|O1|Outcome|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
1138709|NCT00464685|O2|Outcome|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
1138710|NCT00464685|O1|Outcome|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
1138711|NCT00464685|E2|Reported Event|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
1138712|NCT00464685|E1|Reported Event|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
1138713|NCT00464672|B3|Baseline|Total|Total of all reporting groups
1138714|NCT00464672|B2|Baseline|Comparator Influenza Vaccine|Injections of the comparator influenza vaccine were administered intramuscularly
1138715|NCT00464672|B1|Baseline|Influenza Virus Vaccine|Injections of the investigational influenza virus vaccine were administered intramuscularly
1138716|NCT00464672|P6|Participant Flow|Comparator Influenza Vaccine (3 to 8 Years)|Two injections of the comparator influenza vaccine were administered intramuscularly
1138717|NCT00464672|P5|Participant Flow|Influenza Virus Vaccine (3 to 8 Years)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
1138718|NCT00464672|P4|Participant Flow|Comparator Influenza Vaccine (9 to 17 Years)|One injection of the comparator influenza vaccine was administered intramuscularly
1138719|NCT00464672|P3|Participant Flow|Influenza Virus Vaccine (9 to 17 Years)|One injection of the investigational influenza virus vaccine was administered intramuscularly
1138720|NCT00464672|P2|Participant Flow|Comparator Influenza Vaccine (18 to 64 Years)|One injection of the comparator influenza vaccine was administered intramuscularly
1138721|NCT00464672|P1|Participant Flow|Influenza Virus Vaccine (18 to 64 Years)|One injection of the investigational influenza virus vaccine was administered intramuscularly
1145599|NCT00445679|B5|Baseline|Total|Total of all reporting groups
1138722|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|One injection of the comparator influenza vaccine was administered intramuscularly
1138723|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|One injection of the comparator influenza vaccine was administered intramuscularly
1138724|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|One injection of the comparator influenza vaccine was administered intramuscularly
1138725|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|One injection of the investigational influenza virus vaccine was administered intramuscularly
1138726|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|One injection of the investigational influenza virus vaccine was administered intramuscularly
1138727|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|One injection of the investigational influenza virus vaccine was administered intramuscularly
1138728|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (Injection 2)|Injections of the comparator influenza vaccine were administered intramuscularly.
1138813|NCT00464464|B3|Baseline|Total|Total of all reporting groups
1138730|NCT00464672|O2|Outcome|Comparator Influenza Vaccine (Injection 1)|Injections of the comparator influenza vaccine were administered intramuscularly.
1138731|NCT00464672|O1|Outcome|Influenza Virus Vaccine (Injection 1)|Injections of the investigational influenza virus vaccine were administered intramuscularly.
1138732|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|Two injections of the comparator influenza vaccine were administered intramuscularly
1138733|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|Two injections of the comparator influenza vaccine were administered intramuscularly
1138734|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|Two injections of the comparator influenza vaccine were administered intramuscularly
1138735|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
1138736|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
1138737|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
1138738|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|Two injections of the comparator influenza vaccine were administered intramuscularly
1138739|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|Two injections of the comparator influenza vaccine were administered intramuscularly
1138740|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|Two injections of the comparator influenza vaccine were administered intramuscularly
1138741|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
1138742|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
1138743|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
1138744|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|Two injections of the comparator influenza vaccine were administered intramuscularly
1138745|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|Two injections of the comparator influenza vaccine were administered intramuscularly
1138746|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|Two injections of the comparator influenza vaccine were administered intramuscularly
1138747|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
1138748|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
1138749|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
1138750|NCT00464672|O2|Outcome|Comparator Influenza Vaccine|Injection of the comparator influenza vaccine were administered intramuscularly
1138751|NCT00464672|O1|Outcome|Influenza Virus Vaccine|Injection of the investigational influenza virus vaccine were administered intramuscularly
1138752|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|One injection of the comparator influenza vaccine was administered intramuscularly
1138753|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|One injection of the comparator influenza vaccine was administered intramuscularly
1138754|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|One injection of the comparator influenza vaccine was administered intramuscularly
1138755|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|One injection of the investigational influenza virus vaccine was administered intramuscularly
1138756|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|One injection of the investigational influenza virus vaccine was administered intramuscularly
1138757|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|One injection of the investigational influenza virus vaccine was administered intramuscularly
1138758|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|One injection of the comparator influenza vaccine was administered intramuscularly
1138759|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|One injection of the comparator influenza vaccine was administered intramuscularly
1138760|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|One injection of the comparator influenza vaccine was administered intramuscularly
1138761|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|One injection of the investigational influenza virus vaccine was administered intramuscularly
1138762|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|One injection of the investigational influenza virus vaccine was administered intramuscularly
1138763|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|One injection of the investigational influenza virus vaccine was administered intramuscularly
1138764|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|One injection of the comparator influenza vaccine was administered intramuscularly
1138765|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|One injection of the comparator influenza vaccine was administered intramuscularly
1138766|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|One injection of the comparator influenza vaccine was administered intramuscularly
1138767|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|One injection of the investigational influenza virus vaccine was administered intramuscularly
1138768|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|One injection of the investigational influenza virus vaccine was administered intramuscularly
1138769|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|One injection of the investigational influenza virus vaccine was administered intramuscularly
1138770|NCT00464672|O2|Outcome|Comparator Influenza Vaccine|One injection of the comparator influenza vaccine was administered intramuscularly
1138771|NCT00464672|O1|Outcome|Influenza Virus Vaccine|One injection of the investigational influenza virus vaccine was administered intramuscularly
1138772|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|One injection of the comparator influenza vaccine was administered intramuscularly
1138773|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|One injection of the comparator influenza vaccine was administered intramuscularly
1138831|NCT00464438|P2|Participant Flow|Moxifloxacin 0.5%|
1138774|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|One injection of the comparator influenza vaccine was administered intramuscularly
1138775|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|One injection of the investigational influenza virus vaccine was administered intramuscularly
1138776|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|One injection of the investigational influenza virus vaccine was administered intramuscularly
1138777|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|One injection of the investigational influenza virus vaccine was administered intramuscularly
1138778|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|One injection of the comparator influenza vaccine was administered intramuscularly
1138779|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|One injection of the comparator influenza vaccine was administered intramuscularly
1138780|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|One injection of the comparator influenza vaccine was administered intramuscularly
1138781|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|One injection of the investigational influenza virus vaccine was administered intramuscularly
1138782|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|One injection of the investigational influenza virus vaccine was administered intramuscularly
1138783|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|One injection of the investigational influenza virus vaccine was administered intramuscularly
1138784|NCT00464672|E6|Reported Event|Comparator Influenza Vaccine (3 to 8 Years)|Two injections of the comparator influenza vaccine were administered intramuscularly
1138785|NCT00464672|E5|Reported Event|Influenza Virus Vaccine (3 to 8 Years)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
1138786|NCT00464672|E4|Reported Event|Comparator Influenza Vaccine (9 to 17 Years)|One injection of the comparator influenza vaccine was administered intramuscularly
1138787|NCT00464672|E3|Reported Event|Influenza Virus Vaccine (9 to 17 Years)|One injection of the investigational influenza virus vaccine was administered intramuscularly
1138788|NCT00464672|E2|Reported Event|Comparator Influenza Vaccine (18 to 64 Years)|One injection of the comparator influenza vaccine was administered intramuscularly
1138789|NCT00464672|E1|Reported Event|Influenza Virus Vaccine (18 to 64 Years)|One injection of the investigational influenza virus vaccine was administered intramuscularly
1138790|NCT00464646|B3|Baseline|Total|Total of all reporting groups
1138791|NCT00464646|B2|Baseline|Cohort B|• Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
1138792|NCT00464646|B1|Baseline|Cohort A|• Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
1138793|NCT00464646|P2|Participant Flow|Cohort B|• Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
1138794|NCT00464646|P1|Participant Flow|Cohort A|• Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
1138795|NCT00464646|O2|Outcome|Cohort B|• Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
1138796|NCT00464646|O1|Outcome|Cohort A|• Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
1138797|NCT00464646|E2|Reported Event|Cohort B|• Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
1138798|NCT00464646|E1|Reported Event|Cohort A|• Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
1138799|NCT00464542|B1|Baseline|MASH Cohort|This cohort consisted of women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and who had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment
1138800|NCT00464542|P1|Participant Flow|MASH Cohort|This cohort consisted of women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and who had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment
1138801|NCT00464542|O1|Outcome|Post-treatment MASH Cohort|Women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment and who provided daily vaginal smears for 30 days following cessation of metronidazole therapy
1138802|NCT00464542|O1|Outcome|Post-treatment MASH Cohort|Women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment and who provided daily vaginal smears for 30 days following cessation of metronidazole therapy
1138803|NCT00464542|E1|Reported Event|MASH Cohort|This cohort consisted of women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and who had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment
1138804|NCT00464490|B3|Baseline|Total|Total of all reporting groups
1138805|NCT00464490|B2|Baseline|Standard Hospital Protocol (CG)|Control. Standard hospital weaning protocol
1138806|NCT00464490|B1|Baseline|Dexmedetomidine for Extubation (DG)|"Dexmedomidine infusion to facilitate extubation~Dexmedetomidine: Dexmedetomidine .5mcg/kg/hr-.7mcg/kg/hr 1hour prior to extubation. Dexmedetomidine titrated according to blood pressure, RASS and heart rate response and the dose lowered only after sedation was discontinued or markedly reduced."
1138807|NCT00464490|P2|Participant Flow|Standard Hospital Protocol (CG)|Control. Standard hospital weaning protocol
1145600|NCT00445679|B4|Baseline|Paroxetine 20|Paroxetine 20 mg/day
1138808|NCT00464490|P1|Participant Flow|Dexmedetomidine for Extubation (DG)|"Dexmedomidine infusion to facilitate extubation~Dexmedetomidine: Dexmedetomidine .5mcg/kg/hr-.7mcg/kg/hr 1hour prior to extubation. Dexmedetomidine titrated according to blood pressure, RASS and heart rate response and the dose lowered only after sedation was discontinued or markedly reduced."
1138809|NCT00464490|O2|Outcome|Standard Hospital Protocol (CG)|Control. Standard hospital weaning protocol
1138810|NCT00464490|O1|Outcome|Dexmedetomidine for Extubation (DG)|"Dexmedomidine infusion to facilitate extubation~Dexmedetomidine: Dexmedetomidine .5mcg/kg/hr-.7mcg/kg/hr 1hour prior to extubation. Dexmedetomidine titrated according to blood pressure, RASS and heart rate response and the dose lowered only after sedation was discontinued or markedly reduced."
1138811|NCT00464490|E2|Reported Event|Standard Hospital Protocol (CG)|Control. Hospital weaning per standard protocol
1138812|NCT00464490|E1|Reported Event|Dexmedetomidine for Extubation (DG)|"Dexmedomidine infusion to facilitate extubation~Dexmedetomidine: Dexmedetomidine .5mcg/kg/hr-.7mcg/kg/hr 1hour prior to extubation. Dexmedetomidine titrated according to blood pressure, RASS and heart rate response and the dose lowered only after sedation was discontinued or markedly reduced."
1138814|NCT00464464|B2|Baseline|Standard Medical Care Condition|"Participants in the Standard Medical Care condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial."
1138815|NCT00464464|B1|Baseline|Cognitive-Behavioral Therapy Condition|"Participants in the Cognitive-Behavioral Therapy condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD.~These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial."
1138816|NCT00464464|P2|Participant Flow|Standard Medical Care Condition|"Participants in the Standard Medical Care condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial."
1138817|NCT00464464|P1|Participant Flow|Cognitive-Behavioral Therapy Condition|"Participants in the Cognitive-Behavioral Therapy condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD.~These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial."
1138818|NCT00464464|O2|Outcome|Standard Medical Care Condition|"Participants in the Standard Medical Care condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial."
1138819|NCT00464464|O1|Outcome|Cognitive-Behavioral Therapy Condition|"Participants in the Cognitive-Behavioral Therapy condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD.~These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial."
1138820|NCT00464464|O2|Outcome|Standard Medical Care Condition|"Participants in the Standard Medical Care condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial."
1138821|NCT00464464|O1|Outcome|Cognitive-Behavioral Therapy Condition|"Participants in the Cognitive-Behavioral Therapy condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD.~These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial."
1138822|NCT00464464|O2|Outcome|Standard Medical Care Condition|"Participants in the Standard Medical Care condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial."
1138823|NCT00464464|O1|Outcome|Cognitive-Behavioral Therapy Condition|"Participants in the Cognitive-Behavioral Therapy condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD.~These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial."
1138824|NCT00464464|O2|Outcome|Standard Medical Care Condition|"Participants in the Standard Medical Care condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial."
1138892|NCT00464334|O7|Outcome|V950 5 mcg / IMX 0 mcg|Participants receive V950 5 mcg/IMX 0 mcg
1138893|NCT00464334|O6|Outcome|V950 0.5 mcg / IMX 94 mcg|Participants receive V950 0.5 mcg/IMX 94 mcg
1138894|NCT00464334|O5|Outcome|V950 0.5 mcg / IMX 47 mcg|Participants receive V950 0.5 mcg/IMX 47 mcg
1138895|NCT00464334|O4|Outcome|V950 0.5 mcg / IMX 16 mcg|Participants receive V950 0.5 mcg/IMX 16 mcg
1138825|NCT00464464|O1|Outcome|Cognitive-Behavioral Therapy Condition|"Participants in the Cognitive-Behavioral Therapy condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD.~These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial."
1138826|NCT00464464|E2|Reported Event|Standard Medical Care Condition|"Participants in the Standard Medical Care condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial."
1138827|NCT00464464|E1|Reported Event|Cognitive-Behavioral Therapy Condition|"Participants in the Cognitive-Behavioral Therapy condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD.~These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial."
1138828|NCT00464438|B3|Baseline|Total|Total of all reporting groups
1138829|NCT00464438|B2|Baseline|Moxifloxacin 0.5%|
1138830|NCT00464438|B1|Baseline|Gatifloxacin 0.3%|
1138845|NCT00464334|B10|Baseline|V950 50 mcg/IMX 0 mcg|Participants receive V950 50 mcg/IMX 0 mcg
1138846|NCT00464334|B9|Baseline|V950 5 mcg/IMX 47 mcg|Participants receive V950 5 mcg/IMX 47 mcg
1138847|NCT00464334|B8|Baseline|V950 5 mcg/IMX 16 mcg|Participants receive V950 5 mcg/IMX 16 mcg
1138848|NCT00464334|B7|Baseline|V950 5 mcg/IMX 0 mcg|Participants receive V950 5 mcg/IMX 0 mcg
1138849|NCT00464334|B6|Baseline|V950 0.5 mcg/IMX 94 mcg|Participants receive V950 0.5 mcg/IMX 94 mcg
1138850|NCT00464334|B5|Baseline|V950 0.5 mcg/IMX 47 mcg|Participants receive V950 0.5 mcg/IMX 47 mcg
1138851|NCT00464334|B4|Baseline|V950 0.5 mcg/IMX 16 mcg|Participants receive V950 0.5 mcg/IMX 16 mcg
1138852|NCT00464334|B3|Baseline|V950 0.5 mcg/IMX 0 mcg|Participants receive V950 0.5 mcg/IMX 0 mcg
1138853|NCT00464334|B2|Baseline|Placebo to V950/IMX 16 mcg|Participants receive Placebo to V950/IMX 16 mcg
1138854|NCT00464334|B1|Baseline|Placebo to V950/IMX 0 mcg|Participants receive Placebo to V950/IMX 0 mcg
1138855|NCT00464334|P11|Participant Flow|V950 50 mcg/IMX 16 mcg|Participants receive V950 50 mcg/IMX 16 mcg
1138856|NCT00464334|P10|Participant Flow|V950 50 mcg/IMX 0 mcg|Participants receive V950 50 mcg/IMX 0 mcg
1138857|NCT00464334|P9|Participant Flow|V950 5 mcg/IMX 47 mcg|Participants receive V950 5 mcg/IMX 47 mcg
1138858|NCT00464334|P8|Participant Flow|V950 5 mcg/IMX 16 mcg|Participants receive V950 5 mcg/IMX 16 mcg
1138859|NCT00464334|P7|Participant Flow|V950 5 mcg/IMX 0 mcg|Participants receive V950 5 mcg/IMX 0 mcg
1138860|NCT00464334|P6|Participant Flow|V950 0.5 mcg/IMX 94 mcg|Participants receive V950 0.5 mcg/IMX 94 mcg
1138861|NCT00464334|P5|Participant Flow|V950 0.5 mcg/IMX 47 mcg|Participants receive V950 0.5 mcg/IMX 47 mcg
1138862|NCT00464334|P4|Participant Flow|V950 0.5 mcg/IMX 16 mcg|Participants receive V950 0.5 mcg/IMX 16 mcg
1138863|NCT00464334|P3|Participant Flow|V950 0.5 mcg/IMX 0 mcg|Participants receive V950 0.5 mcg/IMX 0 mcg
1138864|NCT00464334|P2|Participant Flow|Placebo to V950/IMX 16 mcg|Participants receive Placebo to V950/IMX 16 mcg
1138865|NCT00464334|P1|Participant Flow|Placebo to V950/IMX 0 mcg|Participants receive Placebo to V950/ISCOMATRIX™ (IMX) 0 mcg
1138866|NCT00464334|O11|Outcome|V950 50 mcg / IMX 16 mcg|Participants receive V950 50 mcg/IMX 16 mcg
1138867|NCT00464334|O10|Outcome|V950 50 mcg / IMX 0 mcg|Participants receive V950 50 mcg/IMX 0 mcg
1138868|NCT00464334|O9|Outcome|V950 5 mcg / IMX 47 mcg|Participants receive V950 5 mcg/IMX 47 mcg
1138869|NCT00464334|O8|Outcome|V950 5 mcg / IMX 16 mcg|Participants receive V950 5 mcg/IMX 16 mcg
1138870|NCT00464334|O7|Outcome|V950 5 mcg / IMX 0 mcg|Participants receive V950 5 mcg/IMX 0 mcg
1138871|NCT00464334|O6|Outcome|V950 0.5 mcg / IMX 94 mcg|Participants receive V950 0.5 mcg/IMX 94 mcg
1138872|NCT00464334|O5|Outcome|V950 0.5 mcg / IMX 47 mcg|Participants receive V950 0.5 mcg/IMX 47 mcg
1138873|NCT00464334|O4|Outcome|V950 0.5 mcg / IMX 16 mcg|Participants receive V950 0.5 mcg/IMX 16 mcg
1138874|NCT00464334|O3|Outcome|V950 0.5 mcg / IMX 0 mcg|Participants receive V950 0.5 mcg/IMX 0 mcg
1138875|NCT00464334|O2|Outcome|Placebo to V950/ IMX 16 mcg|Participants receive Placebo to V950/IMX 16 mcg
1138876|NCT00464334|O1|Outcome|Placebo to V950/ IMX 0 mcg|Participants receive Placebo to V950/IMX 0 mcg
1138877|NCT00464334|O11|Outcome|V950 50 mcg/IMX 16 mcg|Participants receive V950 50 mcg/IMX 16 mcg
1138878|NCT00464334|O10|Outcome|V950 50 mcg/IMX 0 mcg|Participants receive V950 50 mcg/IMX 0 mcg
1138879|NCT00464334|O9|Outcome|V950 5 mcg/IMX 47 mcg|Participants receive V950 5 mcg/IMX 47 mcg
1138880|NCT00464334|O8|Outcome|V950 5 mcg/IMX 16 mcg|Participants receive V950 5 mcg/IMX 16 mcg
1138881|NCT00464334|O7|Outcome|V950 5 mcg/IMX 0 mcg|Participants receive V950 5 mcg/IMX 0 mcg
1138882|NCT00464334|O6|Outcome|V950 0.5 mcg/IMX 94 mcg|Participants receive V950 0.5 mcg/IMX 94 mcg
1138883|NCT00464334|O5|Outcome|V950 0.5 mcg/IMX 47 mcg|Participants receive V950 0.5 mcg/IMX 47 mcg
1138884|NCT00464334|O4|Outcome|V950 0.5 mcg/IMX 16 mcg|Participants receive V950 0.5 mcg/IMX 16 mcg
1138885|NCT00464334|O3|Outcome|V950 0.5 mcg/IMX 0 mcg|Participants receive V950 0.5 mcg/IMX 0 mcg
1138886|NCT00464334|O2|Outcome|Placebo to V950/IMX 16 mcg|Participants receive Placebo to V950/IMX 16 mcg
1138887|NCT00464334|O1|Outcome|Placebo to V950/IMX 0 mcg|Participants receive Placebo to V950/IMX 0 mcg
1138888|NCT00464334|O11|Outcome|V950 50 mcg / IMX 16 mcg|Participants receive V950 50 mcg/IMX 16 mcg
1138889|NCT00464334|O10|Outcome|V950 50 mcg / IMX 0 mcg|Participants receive V950 50 mcg/IMX 0 mcg
1138890|NCT00464334|O9|Outcome|V950 5 mcg / IMX 47 mcg|Participants receive V950 5 mcg/IMX 47 mcg
1138891|NCT00464334|O8|Outcome|V950 5 mcg / IMX 16 mcg|Participants receive V950 5 mcg/IMX 16 mcg
1138896|NCT00464334|O3|Outcome|V950 0.5 mcg / IMX 0 mcg|Participants receive V950 0.5 mcg/IMX 0 mcg
1138897|NCT00464334|O2|Outcome|Placebo to V950/ IMX 16 mcg|Participants receive Placebo to V950/IMX 16 mcg
1138898|NCT00464334|O1|Outcome|Placebo to V950/ IMX 0 mcg|Participants receive Placebo to V950/IMX 0 mcg
1138899|NCT00464334|O11|Outcome|V950 50 mcg / IMX 16 mcg|Participants receive V950 50 mcg/IMX 16 mcg
1138900|NCT00464334|O10|Outcome|V950 50 mcg / IMX 0 mcg|Participants receive V950 50 mcg/IMX 0 mcg
1138901|NCT00464334|O9|Outcome|V950 5 mcg / IMX 47 mcg|Participants receive V950 5 mcg/IMX 47 mcg
1138902|NCT00464334|O8|Outcome|V950 5 mcg / IMX 16 mcg|Participants receive V950 5 mcg/IMX 16 mcg
1138903|NCT00464334|O7|Outcome|V950 5 mcg / IMX 0 mcg|Participants receive V950 5 mcg/IMX 0 mcg
1138904|NCT00464334|O6|Outcome|V950 0.5 mcg / IMX 94 mcg|Participants receive V950 0.5 mcg/IMX 94 mcg
1138905|NCT00464334|O5|Outcome|V950 0.5 mcg / IMX 47 mcg|Participants receive V950 0.5 mcg/IMX 47 mcg
1138906|NCT00464334|O4|Outcome|V950 0.5 mcg / IMX 16 mcg|Participants receive V950 0.5 mcg/IMX 16 mcg
1138907|NCT00464334|O3|Outcome|V950 0.5 mcg / IMX 0 mcg|Participants receive V950 0.5 mcg/IMX 0 mcg
1138908|NCT00464334|O2|Outcome|Placebo to V950/ IMX 16 mcg|Participants receive Placebo to V950/IMX 16 mcg
1138909|NCT00464334|O1|Outcome|Placebo to V950/ IMX 0 mcg|Participants receive Placebo to V950/IMX 0 mcg
1138910|NCT00464334|E11|Reported Event|V950 50 mcg / IMX 16 mcg|Participants receive V950 50 mcg/IMX 16 mcg
1138911|NCT00464334|E10|Reported Event|V950 50 mcg / IMX 0 mcg|Participants receive V950 50 mcg/IMX 0 mcg
1138912|NCT00464334|E9|Reported Event|V950 5 mcg / IMX 47 mcg|Participants receive V950 5 mcg/IMX 47 mcg
1138913|NCT00464334|E8|Reported Event|V950 5 mcg / IMX 16 mcg|Participants receive V950 5 mcg/IMX 16 mcg
1138914|NCT00464334|E7|Reported Event|V950 5 mcg / IMX 0 mcg|Participants receive V950 5 mcg/IMX 0 mcg
1138915|NCT00464334|E6|Reported Event|V950 0.5 mcg / IMX 94 mcg|Participants receive V950 0.5 mcg/IMX 94 mcg
1138916|NCT00464334|E5|Reported Event|V950 0.5 mcg / IMX 47 mcg|Participants receive V950 0.5 mcg/IMX 47 mcg
1138917|NCT00464334|E4|Reported Event|V950 0.5 mcg / IMX 16 mcg|Participants receive V950 0.5 mcg/IMX 16 mcg
1138918|NCT00464334|E3|Reported Event|V950 0.5 mcg / IMX 0 mcg|Participants receive V950 0.5 mcg/IMX 0 mcg
1138919|NCT00464334|E2|Reported Event|Placebo to V950/ IMX 16 mcg|Participants receive Placebo to V950/IMX 16 mcg
1138920|NCT00464334|E1|Reported Event|Placebo to V950/ IMX 0 mcg|Participants receive Placebo to V950/IMX 0 mcg
1138921|NCT00464308|B4|Baseline|Total|Total of all reporting groups
1138922|NCT00464308|B3|Baseline|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
1138923|NCT00464308|B2|Baseline|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
1138924|NCT00464308|B1|Baseline|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
1138925|NCT00464308|P3|Participant Flow|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
1138926|NCT00464308|P2|Participant Flow|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
1138927|NCT00464308|P1|Participant Flow|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
1138928|NCT00464308|O3|Outcome|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
1138929|NCT00464308|O2|Outcome|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
1138930|NCT00464308|O1|Outcome|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
1138931|NCT00464308|O3|Outcome|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
1138932|NCT00464308|O2|Outcome|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
1138933|NCT00464308|O1|Outcome|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
1138934|NCT00464308|O3|Outcome|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
1138935|NCT00464308|O2|Outcome|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
1138936|NCT00464308|O1|Outcome|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
1138937|NCT00464308|O3|Outcome|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
1138938|NCT00464308|O2|Outcome|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
1138939|NCT00464308|O1|Outcome|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
1138940|NCT00464308|O3|Outcome|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
1138941|NCT00464308|O2|Outcome|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
1138942|NCT00464308|O1|Outcome|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
1138943|NCT00464308|O3|Outcome|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
1138944|NCT00464308|O2|Outcome|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
1138945|NCT00464308|O1|Outcome|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
1138946|NCT00464308|O3|Outcome|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
1147681|NCT00441363|P1|Participant Flow|Cycloset|0.8 mg tablet
1138947|NCT00464308|O2|Outcome|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
1138948|NCT00464308|O1|Outcome|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
1138949|NCT00464308|E3|Reported Event|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
1138950|NCT00464308|E2|Reported Event|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
1138951|NCT00464308|E1|Reported Event|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
1138952|NCT00464269|B5|Baseline|Total Title|
1138953|NCT00464269|B4|Baseline|BRV 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
1138954|NCT00464269|B3|Baseline|BRV 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
1138955|NCT00464269|B2|Baseline|BRV 5 mg/Day|Brivaracetam 5 mg/day, 2.5 mg administered twice a day
1138956|NCT00464269|B1|Baseline|Placebo|Matching Placebo tablets administered twice a day
1140904|NCT00460239|O7|Outcome|Buprenorphine 48 mg|
1138957|NCT00464269|P4|Participant Flow|BRV 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
1138958|NCT00464269|P3|Participant Flow|BRV 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
1138959|NCT00464269|P2|Participant Flow|BRV 5 mg/Day|Brivaracetam 5 mg/day, 2.5 mg administered twice a day
1138960|NCT00464269|P1|Participant Flow|Placebo|Matching Placebo tablets administered twice a day
1138961|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138962|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138963|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138964|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138965|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138966|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138967|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138968|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138969|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138970|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138971|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139130|NCT00463866|O2|Outcome|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
1138972|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138973|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138974|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139085|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
1138975|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138976|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138977|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138978|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138979|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138980|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138981|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138982|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138983|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138984|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138985|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138986|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138987|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138988|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138989|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139086|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
1138990|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138991|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138992|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138993|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138994|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138995|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138996|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138997|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138998|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1138999|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139000|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139001|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139002|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139003|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139004|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139087|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
1139005|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139006|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139007|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139008|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139009|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139010|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139011|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139012|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139013|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139014|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139015|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139016|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139017|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139018|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139019|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139088|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
1139020|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139021|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139022|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139023|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139024|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139025|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139026|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139027|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139028|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139029|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139030|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139031|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139032|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139033|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139034|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139089|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
1139035|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139036|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139037|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139038|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139039|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139040|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139041|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139042|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139043|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139044|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139045|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139046|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139047|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139048|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139049|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139090|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
1139050|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139051|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam (BRV) 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139052|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant Good Clinical Practice (GCP) deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
1139053|NCT00464269|E4|Reported Event|BRV 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
1139054|NCT00464269|E3|Reported Event|BRV 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
1139055|NCT00464269|E2|Reported Event|BRV 5 mg/Day|Brivaracetam 5 mg/day, 2.5 mg administered twice a day
1139056|NCT00464269|E1|Reported Event|Placebo|Matching Placebo tablets administered twice a day
1139057|NCT00464204|B3|Baseline|Total|Total of all reporting groups
1139058|NCT00464204|B2|Baseline|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
1139059|NCT00464204|B1|Baseline|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
1139060|NCT00464204|P2|Participant Flow|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
1139061|NCT00464204|P1|Participant Flow|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
1139062|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
1139063|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
1139064|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
1139065|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
1139066|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
1139067|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
1139068|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 % NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
1139069|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4 Voluven® rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day.
1139070|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
1139071|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
1139072|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
1139073|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
1139074|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
1139075|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
1139076|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
1139077|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
1139078|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
1139079|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
1139080|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
1139081|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
1139082|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
1139083|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
1139084|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
1140905|NCT00460239|O6|Outcome|Buprenorphine 32 mg|
1139091|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
1139092|NCT00464204|E2|Reported Event|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
1139093|NCT00464204|E1|Reported Event|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
1139094|NCT00464087|B4|Baseline|Total|Total of all reporting groups
1139095|NCT00464087|B3|Baseline|Screen Failures|Screen Failures are patients who are enrolled and receive the study drug, but do not have enough disease to have percutaneous coronary intervention.
1139096|NCT00464087|B2|Baseline|Bivalirudin|bivalirudin during angioplasty
1139097|NCT00464087|B1|Baseline|Heparin|unfrationated heparin during angioplasty
1139098|NCT00464087|P3|Participant Flow|Screen Failures|These patients were enrolled because they received study drug, but did not have enough disease to require PCI.
1139099|NCT00464087|P2|Participant Flow|Bivalirudin|All patients received fondaparinux at a dose of 2.5 mg subcutaneously no more than 24 hours before angioplasty. They are randomized to Bivalirudin during angioplasty and receive a minimum dose of bolus 0.75 mg/kg IV followed by, infusion of 1.75 mg/kg/hr for the duration of the PCI.
1139100|NCT00464087|P1|Participant Flow|Heparin|All patients received fondaparinux at a dose of 2.5 mg subcutaneously no more than 24 hours before angioplasty. They are randomized to unfractionated heparin during angioplasty and receive a minimum dose of 60 U/kg IV.
1139101|NCT00464087|O3|Outcome|Screen Failures|Screen Failures are patients who are enrolled and receive the study drug, but do not have enough disease to have percutaneous coronary intervention.
1139102|NCT00464087|O2|Outcome|Bivalirudin|bivalirudin during angioplasty
1139103|NCT00464087|O1|Outcome|Heparin|unfractionated heparin during angioplasty
1139104|NCT00464087|O3|Outcome|Screen Failures|Screen Failures are patients who are enrolled and receive the study drug, but do not have enough disease to have percutaneous coronary intervention.
1139105|NCT00464087|O2|Outcome|Bivalirudin|bivalirudin during angioplasty
1139106|NCT00464087|O1|Outcome|Heparin|unfractionated heparin during angioplasty
1139107|NCT00464087|O2|Outcome|Bivalirudin|bivalirudin during angioplasty
1139108|NCT00464087|O1|Outcome|Heparin|unfractionated heparin during angioplasty
1139109|NCT00464087|O3|Outcome|Screen Failures|Screen Failures are patients who are enrolled and receive the study drug, but do not have enough disease to have percutaneous coronary intervention.
1139110|NCT00464087|O2|Outcome|Bivalirudin|bivalirudin during angioplasty
1139111|NCT00464087|O1|Outcome|Heparin|unfractionated heparin during angioplasty
1139112|NCT00464087|E3|Reported Event|Screen Failures|Screen Failures are patients who are enrolled and receive the study drug, but do not have enough disease to have percutaneous coronary intervention.
1139113|NCT00464087|E2|Reported Event|Bivalirudin|bivalirudin during angioplasty
1139114|NCT00464087|E1|Reported Event|Heparin|unfrationated heparin during angioplasty
1139115|NCT00463866|B3|Baseline|Total|Total of all reporting groups
1139116|NCT00463866|B2|Baseline|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
1139117|NCT00463866|B1|Baseline|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
1139118|NCT00463866|P2|Participant Flow|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
1139119|NCT00463866|P1|Participant Flow|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
1139120|NCT00463866|O2|Outcome|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
1139121|NCT00463866|O1|Outcome|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
1139122|NCT00463866|O2|Outcome|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
1139123|NCT00463866|O1|Outcome|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
1139124|NCT00463866|O2|Outcome|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
1139125|NCT00463866|O1|Outcome|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
1139126|NCT00463866|O2|Outcome|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
1139127|NCT00463866|O1|Outcome|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
1139128|NCT00463866|O2|Outcome|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
1139129|NCT00463866|O1|Outcome|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
1139131|NCT00463866|O1|Outcome|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
1139132|NCT00463866|O2|Outcome|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
1139133|NCT00463866|O1|Outcome|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
1139134|NCT00463866|O2|Outcome|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
1139135|NCT00463866|O1|Outcome|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
1139136|NCT00463866|E2|Reported Event|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
1139137|NCT00463866|E1|Reported Event|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
1139155|NCT00463788|O2|Outcome|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.
1139195|NCT00463580|P2|Participant Flow|Placebo|Participants in this arm receive normal saline at Baseline and at weeks 2 and 6 of a 12- week trial.
1139196|NCT00463580|P1|Participant Flow|Infliximab|Participants in this arm receive Infliximab(5mg/kg)at Baseline and at weeks 2 and 6 of a 12-week trial.
1139138|NCT00463840|B1|Baseline|Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6|"Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery:~Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal;~Combined with :~5FU 200 mg/m^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m^2 Oxaliplatin were tested).~Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable.~Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle):~Day 1 hour 0: Oxaliplatin 85 mg/m^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 IV over 46 hours."
1139139|NCT00463840|P1|Participant Flow|Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6|"Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery:~Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal;~Combined with :~5FU 200 mg/m^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m^2 Oxaliplatin were tested).~Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable.~Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle):~Day 1 hour 0: Oxaliplatin 85 mg/m^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 IV over 46 hours."
1139140|NCT00463840|O1|Outcome|Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6|"Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery:~Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal;~Combined with :~5FU 200 mg/m^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m^2 Oxaliplatin were tested).~Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable.~Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle):~Day 1 hour 0: Oxaliplatin 85 mg/m^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 IV over 46 hours."
1139141|NCT00463840|E1|Reported Event|Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6|"Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery:~Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal;~Combined with :~5FU 200 mg/m^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m^2 Oxaliplatin were tested).~Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable.~Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle):~Day 1 hour 0: Oxaliplatin 85 mg/m^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 IV over 46 hours."
1139142|NCT00463801|B1|Baseline|Daptomycin Intravenous|350 mg of Daptomycin was supplied as sterile lyophilized powder in glass vials. Each vial was to be reconstituted with 7 mL of normal saline or water for injection, to give a 50 mg/mL drug concentration. Daptomycin was to be administered as a 30-minute intravenous infusion, once daily for at least 7 days, at the dose of 4 mg/Kg, up to a maximum of 14 days.
1139143|NCT00463801|P1|Participant Flow|Daptomycin Intravenous|350 mg of Daptomycin was supplied as sterile lyophilized powder in glass vials. Each vial was to be reconstituted with 7 mL of normal saline or water for injection, to give a 50 mg/mL drug concentration. Daptomycin was to be administered as a 30-minute intravenous infusion, once daily for at least 7 days, at the dose of 4 mg/Kg, up to a maximum of 14 days.
1139144|NCT00463801|O1|Outcome|Daptomycin Intravenous|350 mg of Daptomycin was supplied as sterile lyophilized powder in glass vials. Each vial was to be reconstituted with 7 mL of normal saline or water for injection, to give a 50 mg/mL drug concentration. Daptomycin was to be administered as a 30-minute intravenous infusion, once daily for at least 7 days, at the dose of 4 mg/Kg, up to a maximum of 14 days.
1139145|NCT00463801|E1|Reported Event|All Patients|All patients
1139146|NCT00463788|B3|Baseline|Total|Total of all reporting groups
1139147|NCT00463788|B2|Baseline|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.
1139148|NCT00463788|B1|Baseline|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.
1139149|NCT00463788|P2|Participant Flow|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.
1139150|NCT00463788|P1|Participant Flow|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.
1139151|NCT00463788|O2|Outcome|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.
1139152|NCT00463788|O1|Outcome|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.
1139153|NCT00463788|O2|Outcome|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.
1139154|NCT00463788|O1|Outcome|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.
1139194|NCT00463580|B1|Baseline|Infliximab|Infliximab
1139156|NCT00463788|O1|Outcome|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.
1139157|NCT00463788|O2|Outcome|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.
1139158|NCT00463788|O1|Outcome|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.
1139159|NCT00463788|O2|Outcome|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.
1139160|NCT00463788|O1|Outcome|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.
1139161|NCT00463788|E3|Reported Event|Cisplatin Alone Switched to Cetuximab|On progression, participants in the cisplatin group had the option to switch to cisplatin (75 mg/m^2 IV infusion) plus cetuximab (initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion) if the progressive disease was reported during the 6 cisplatin cycles or to cetuximab alone (initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion) if the progression was reported after the 6 cisplatin cycles.
1139162|NCT00463788|E2|Reported Event|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of progressive disease (PD), unacceptable toxicity or withdrawal of consent.
1139163|NCT00463788|E1|Reported Event|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly.
1139164|NCT00463606|B4|Baseline|Total|Total of all reporting groups
1139165|NCT00463606|B3|Baseline|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
1139166|NCT00463606|B2|Baseline|ABT-335|ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks
1139167|NCT00463606|B1|Baseline|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
1139168|NCT00463606|P3|Participant Flow|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
1139169|NCT00463606|P2|Participant Flow|ABT-335|ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks
1139170|NCT00463606|P1|Participant Flow|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
1139171|NCT00463606|O2|Outcome|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
1139172|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
1139173|NCT00463606|O2|Outcome|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
1139174|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
1139175|NCT00463606|O2|Outcome|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
1139176|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
1139177|NCT00463606|O2|Outcome|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
1139178|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
1139179|NCT00463606|O2|Outcome|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
1139180|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
1139181|NCT00463606|O2|Outcome|ABT-335|ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks
1139182|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
1139183|NCT00463606|O2|Outcome|ABT-335|ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks
1139184|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
1139185|NCT00463606|O2|Outcome|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
1139186|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
1139187|NCT00463606|O2|Outcome|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
1139188|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
1139189|NCT00463606|E3|Reported Event|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
1139190|NCT00463606|E2|Reported Event|ABT-335|ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks
1139191|NCT00463606|E1|Reported Event|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
1139192|NCT00463580|B3|Baseline|Total|Total of all reporting groups
1139193|NCT00463580|B2|Baseline|Placebo|
1139197|NCT00463580|O2|Outcome|Placebo|Participants in this arm receive normal saline at Baseline and at weeks 2 and 6 of a 12- week trial.
1139198|NCT00463580|O1|Outcome|Infliximab|Participants in this arm receive Infliximab(5mg/kg)at Baseline and at weeks 2 and 6 of a 12-week trial.
1139199|NCT00463580|O2|Outcome|Placebo|Normal Saline
1139200|NCT00463580|O1|Outcome|Infliximab|Infliximab
1139201|NCT00463580|E2|Reported Event|Infliximab|Participants in this arm receive Infliximab(5mg/kg)at Baseline and at weeks 2 and 6 of a 12-week trial.
1139202|NCT00463580|E1|Reported Event|Placebo|Participants in this arm receive normal saline at Baseline and at weeks 2 and 6 of a 12- week trial.
1139203|NCT00463567|B8|Baseline|Total|Total of all reporting groups
1139204|NCT00463567|B7|Baseline|Formoterol 12 µg (Not Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139205|NCT00463567|B6|Baseline|Indacaterol 600 µg (Not Continued Into Stage 2)|"In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139206|NCT00463567|B5|Baseline|Indacaterol 75 µg (Not Continued Into Stage 2)|"In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139207|NCT00463567|B4|Baseline|Placebo (Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139208|NCT00463567|B3|Baseline|Tiotropium 18 µg (Continued Into Stage 2)|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139209|NCT00463567|B2|Baseline|Indacaterol 300 µg (Continued Into Stage 2)|"In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139210|NCT00463567|B1|Baseline|Indacaterol 150 µg (Continued Into Stage 2)|"In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139211|NCT00463567|P7|Participant Flow|Formoterol 12 µg (Not Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139212|NCT00463567|P6|Participant Flow|Indacaterol 600 µg (Not Continued Into Stage 2)|"In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139213|NCT00463567|P5|Participant Flow|Indacaterol 75 µg (Not Continued Into Stage 2)|"In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1147682|NCT00441363|O2|Outcome|Placebo|matching placebo
1139214|NCT00463567|P4|Participant Flow|Placebo (Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139215|NCT00463567|P3|Participant Flow|Tiotropium (Continued Into Stage 2)|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139216|NCT00463567|P2|Participant Flow|Indacaterol 300 µg (Continued Into Stage 2)|"In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139217|NCT00463567|P1|Participant Flow|Indacaterol 150 µg (Continued Into Stage 2)|"In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139218|NCT00463567|O7|Outcome|Formoterol 12 µg|"In the morning, Placebo to Indacaterol delivered via SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139219|NCT00463567|O6|Outcome|Indacaterol 600 µg|"In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139220|NCT00463567|O5|Outcome|Indacaterol 75 µg|"In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139221|NCT00463567|O4|Outcome|Placebo|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139222|NCT00463567|O3|Outcome|Tiotropium 18 µg|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®).~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139223|NCT00463567|O2|Outcome|Indacaterol 300 µg|"In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139224|NCT00463567|O1|Outcome|Indacaterol 150 µg|"In the morning, Indacaterol 150 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139225|NCT00463567|O7|Outcome|Formoterol 12 µg|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139226|NCT00463567|O6|Outcome|Indacaterol 600 µg|"In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139227|NCT00463567|O5|Outcome|Indacaterol 75 µg|"In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139228|NCT00463567|O4|Outcome|Placebo|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139229|NCT00463567|O3|Outcome|Tiotropium 18 µg|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®).~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139230|NCT00463567|O2|Outcome|Indacaterol 300 µg|"In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139231|NCT00463567|O1|Outcome|Indacaterol 150 µg|"In the morning, Indacaterol 150 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139232|NCT00463567|O4|Outcome|Placebo (Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139233|NCT00463567|O3|Outcome|Tiotropium (Continued Into Stage 2)|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139234|NCT00463567|O2|Outcome|Indacaterol 300 µg (Continued Into Stage 2)|"In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139235|NCT00463567|O1|Outcome|Indacaterol 150 µg (Continued Into Stage 2)|"In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139236|NCT00463567|O4|Outcome|Placebo (Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139237|NCT00463567|O3|Outcome|Tiotropium 18 µg (Continued Into Stage 2)|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139238|NCT00463567|O2|Outcome|Indacaterol 300 µg (Continued Into Stage 2)|"In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139239|NCT00463567|O1|Outcome|Indacaterol 150 µg (Continued Into Stage 2)|"In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139240|NCT00463567|E7|Reported Event|Formoterol 12 µg (Not Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139241|NCT00463567|E6|Reported Event|Indacaterol 600 µg (Not Continued Into Stage 2)|"In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139242|NCT00463567|E5|Reported Event|Indacaterol 75 µg (Not Continued Into Stage 2)|"In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139243|NCT00463567|E4|Reported Event|Placebo (Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139244|NCT00463567|E3|Reported Event|Tiotropium 18 µg (Continued Into Stage 2)|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139245|NCT00463567|E2|Reported Event|Indacaterol 300 µg (Continued Into Stage 2)|"In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1147683|NCT00441363|O1|Outcome|Cycloset|0.8 mg tablet
1139246|NCT00463567|E1|Reported Event|Indacaterol 150 µg (Continued Into Stage 2)|"In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
1139247|NCT00463437|B5|Baseline|Total|Total of all reporting groups
1139248|NCT00463437|B4|Baseline|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139249|NCT00463437|B3|Baseline|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139656|NCT00462709|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 7 days.
1139250|NCT00463437|B2|Baseline|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
1139251|NCT00463437|B1|Baseline|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
1139252|NCT00463437|P4|Participant Flow|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139253|NCT00463437|P3|Participant Flow|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139254|NCT00463437|P2|Participant Flow|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
1139255|NCT00463437|P1|Participant Flow|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
1139256|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139257|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139258|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
1139259|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
1139260|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139261|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139262|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
1139263|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
1139264|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139375|NCT00463346|B1|Baseline|Acamprosate|Acamprosate 1998 mg TID dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
1140853|NCT00460239|B1|Baseline|All Study Participants|All Study Participants
1139265|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139266|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
1139267|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
1139268|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139269|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139270|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
1139271|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
1139272|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139273|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139274|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
1139275|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
1139276|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139277|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139278|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
1139279|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
1139280|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139281|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139282|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
1139283|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
1139284|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139285|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139286|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
1139287|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
1139288|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139289|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139290|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
1139291|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
1139292|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139293|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139294|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
1139295|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
1139296|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139297|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139298|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
1139299|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
1139300|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139301|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139302|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
1139303|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
1139304|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139305|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139306|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
1139307|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
1139308|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139309|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139310|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
1139311|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
1139312|NCT00463437|E4|Reported Event|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139313|NCT00463437|E3|Reported Event|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
1139314|NCT00463437|E2|Reported Event|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
1139315|NCT00463437|E1|Reported Event|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
1139316|NCT00463385|B5|Baseline|Total|Total of all reporting groups
1139317|NCT00463385|B4|Baseline|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139318|NCT00463385|B3|Baseline|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139319|NCT00463385|B2|Baseline|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139320|NCT00463385|B1|Baseline|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
1139321|NCT00463385|P4|Participant Flow|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139376|NCT00463346|P2|Participant Flow|Placebo|dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
1139377|NCT00463346|P1|Participant Flow|Acamprosate|Acamprosate 1998 mg TID dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
1139322|NCT00463385|P3|Participant Flow|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139323|NCT00463385|P2|Participant Flow|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139324|NCT00463385|P1|Participant Flow|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
1139363|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139325|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139326|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139327|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139328|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
1139329|NCT00463385|O8|Outcome|Pomalidomide 0.5 mg + Prednisone, Negative JAK2|"Participants with a negative JAK2 result at Baseline received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139330|NCT00463385|O7|Outcome|Pomalidomide 2 mg + Prednisone, Negative JAK2|"Participants with a negative JAK2 result at Baseline received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139331|NCT00463385|O6|Outcome|Pomalidomide 2 mg, Negative JAK2|"Participants with a negative JAK2 result at Baseline received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139332|NCT00463385|O5|Outcome|Prednisone, Negative JAK2|"Participants with a negative JAK2 result at Baseline received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
1139372|NCT00463385|E1|Reported Event|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
1139373|NCT00463346|B3|Baseline|Total|Total of all reporting groups
1139333|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone, Positive JAK2|"Participants with a positive JAK2 result at Baseline received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139334|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone, Positive JAK2|"Participants with a positive JAK2 result at Baseline received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139335|NCT00463385|O2|Outcome|Pomalidomide 2 mg, PositiveJAK2|"Participants with a positive JAK2 result at Baseline received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139336|NCT00463385|O1|Outcome|Prednisone, Positive JAK2|"Participants with a positive JAK2 result at Baseline received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
1139657|NCT00462709|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 7 days.
1139658|NCT00462709|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 7 days.
1139337|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139338|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139339|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139340|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
1139341|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139342|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139343|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139344|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
1139374|NCT00463346|B2|Baseline|Placebo|Placebo dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
1147684|NCT00441363|O2|Outcome|Placebo|matching placebo
1139345|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139346|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139347|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139348|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
1139349|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139350|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139351|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139352|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
1139353|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139354|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139355|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139356|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
1139357|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139358|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139359|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139360|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
1139361|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139362|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139364|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
1139365|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139366|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139367|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139368|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
1139369|NCT00463385|E4|Reported Event|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139370|NCT00463385|E3|Reported Event|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139371|NCT00463385|E2|Reported Event|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
1139378|NCT00463346|O2|Outcome|Placebo|placebo Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
1139379|NCT00463346|O1|Outcome|Acamprosate|"Acamprosate~Acamprosate: Acamprosate 1998 mg tid. Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules."
1139380|NCT00463346|O2|Outcome|Placebo|Placebo Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
1139381|NCT00463346|O1|Outcome|Acamprosate|"Acamprosate~1998 mg TID Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules."
1139382|NCT00463346|E2|Reported Event|Placebo|placebo Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
1139383|NCT00463346|E1|Reported Event|Acamprosate|Acamprosate 1998 mg tid. Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
1139384|NCT00463229|B3|Baseline|Total|Total of all reporting groups
1139385|NCT00463229|B2|Baseline|Usual Home Care Services|Participants allocated to the control group received standard home care services arranged by the CCAC. These include routine follow-up by the CCAC case manager whose focus is on assessment and referral to community agencies, and ongoing monitoring and evaluating the plan of care through in-home assessment with clients.
1140906|NCT00460239|O5|Outcome|Buprenorphine 16 mg|
1139386|NCT00463229|B1|Baseline|Interprofessional Team Approach|Participants in the experimental group will receive home care services from a team of professional service providers (CCAC Care Coordinator, Registered Nurse, Occupational therapist, Physiotherapist, Speech language pathologist, Nutritionist) and non-professional service providers (personal support workers) with experience and training in stroke care. The team will provide a comprehensive, coordinated and evidence-based approach to stroke rehabilitation through weekly case conferencing, a written interdisciplinary care plan, and joint visits.
1139387|NCT00463229|P2|Participant Flow|Usual Home Care Services|Participants allocated to the control group received standard home care services arranged by the CCAC. These include routine follow-up by the CCAC case manager whose focus is on assessment and referral to community agencies, and ongoing monitoring and evaluating the plan of care through in-home assessment with clients.
1139388|NCT00463229|P1|Participant Flow|Interprofessional Team Approach|Participants in the experimental group will receive home care services from a team of professional service providers (CCAC Care Coordinator, Registered Nurse, Occupational therapist, Physiotherapist, Speech language pathologist, Nutritionist) and non-professional service providers (personal support workers) with experience and training in stroke care. The team will provide a comprehensive, coordinated and evidence-based approach to stroke rehabilitation through weekly case conferencing, a written interdisciplinary care plan, and joint visits.
1139389|NCT00463229|O2|Outcome|Usual Home Care Services|Participants allocated to the control group received standard home care services arranged by the CCAC. These include routine follow-up by the CCAC case manager whose focus is on assessment and referral to community agencies, and ongoing monitoring and evaluating the plan of care through in-home assessment with clients.
1139390|NCT00463229|O1|Outcome|Interprofessional Team Approach|Participants in the experimental group will receive home care services from a team of professional service providers (CCAC Care Coordinator, Registered Nurse, Occupational therapist, Physiotherapist, Speech language pathologist, Nutritionist) and non-professional service providers (personal support workers) with experience and training in stroke care. The team will provide a comprehensive, coordinated and evidence-based approach to stroke rehabilitation through weekly case conferencing, a written interdisciplinary care plan, and joint visits.
1139391|NCT00463229|E2|Reported Event|Usual Home Care Services|Participants allocated to the control group received standard home care services arranged by the CCAC. These include routine follow-up by the CCAC case manager whose focus is on assessment and referral to community agencies, and ongoing monitoring and evaluating the plan of care through in-home assessment with clients.
1139392|NCT00463229|E1|Reported Event|Interprofessional Team Approach|Participants in the experimental group will receive home care services from a team of professional service providers (CCAC Care Coordinator, Registered Nurse, Occupational therapist, Physiotherapist, Speech language pathologist, Nutritionist) and non-professional service providers (personal support workers) with experience and training in stroke care. The team will provide a comprehensive, coordinated and evidence-based approach to stroke rehabilitation through weekly case conferencing, a written interdisciplinary care plan, and joint visits.
1139393|NCT00463047|B1|Baseline|Total Number of Patients|Fentanyl Buccal Tablets (FBT) and Immediate-Release Oxycodone crossover. The total number of patients (323) reflect the number that were enrolled to participate in the study prior to the first titration period. Three subjects withdrew before receiving any study drug so they are not listed as being assigned to either dosing arm in the titration studies, leaving only 320 subjects who were evenly divided between the two groups.
1139394|NCT00463047|P2|Participant Flow|Immediate-Release Oxycodone First FBT Second|Patients were randomly assigned 1:1 to either titrate FBT during the first titration period and then titrated immediate-release oxycodone during the second period or the reverse. Titration began with either 200 mcg FBT or 15 mg oxycodone taken as needed for breakthrough pain. If after 30 minutes pain relief was unsuccessful, a second dose could be taken. If more than one dose was required for at least 1 of 3 breakthrough pain episodes in one day, the next day the dose was increased in 200 mcg increments for FBT and 15 mg increments for oxycodone. The maximum allowable dose was 800 mcg for FBT (4 tablets) and 60 mg (4 capsules) for oxycodone. If a dose was not tolerated the dose was lowered to the previous tolerated dose. Titration completed when successful analgesia was achieved with a tolerated dose or maximum dose was reached. If unsuccessful at maximum dose subject was discontinued from proceeding further in the study. Subjects who successfully titrated were randomized.
1139415|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139416|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1147685|NCT00441363|O1|Outcome|Cycloset|0.8 mg tablet
1139395|NCT00463047|P1|Participant Flow|FBT First Immediate Release Oxycodone Second|Patients were randomized 1:1 to titrate Fentanyl Buccal Tablet (FBT) during the first titration period and then titrated immediate-release oxycodone during the second period or the reverse. Titration began with either 200 mcg FBT or 15 mg oxycodone taken as needed for breakthrough pain. If after 30 minutes pain relief was unsuccessful, a second dose could be taken. If more than one dose was required for at least 1 of 3 breakthrough pain episodes in one day, the next day the dose was increased in 200 mcg increments for FBT and 15 mg increments for oxycodone. The maximum allowable dose was 800 mcg for FBT (4 tablets) and 60 mg (4 capsules) for oxycodone. If a dose was not tolerated the dose was lowered to the previous tolerated dose. Titration completed when successful analgesia was achieved with a tolerated dose or maximum dose was reached. If unsuccessful at maximum dose subject was discontinued from proceeding further in the study. Subjects who successfully titrated were randomized.
1139396|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139397|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139398|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139399|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1140171|NCT00461500|E2|Reported Event|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
1139400|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139401|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139402|NCT00463047|O1|Outcome|Total|Includes all patients who participated in the double-blind treatment period and completed treatment.
1139403|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139404|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139405|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139406|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139407|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139408|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139409|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139410|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139411|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139412|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139413|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139414|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139482|NCT00462982|E1|Reported Event|Sunitinib|Patients will be treated with 50 mg daily for four out of every six weeks.
1139483|NCT00462943|B4|Baseline|Total|Total of all reporting groups
1139417|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139418|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139419|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139420|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139421|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139422|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139423|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139424|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139425|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139426|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139427|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139428|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139429|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139430|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139431|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139432|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139433|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139434|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139435|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139436|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139437|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139438|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139702|NCT00462462|B1|Baseline|L0122 Gel Group|Patients who received one intralesional administration of L0122 gel
1147686|NCT00441363|E2|Reported Event|Placebo|matching placebo
1139439|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139440|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139441|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139442|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139443|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139444|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139659|NCT00462709|E1|Reported Event|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 7 days.
1139660|NCT00462670|B3|Baseline|Total|Total of all reporting groups
1139445|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139446|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139447|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139448|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139449|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139450|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139451|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139452|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139453|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139454|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139455|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139456|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139457|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139458|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139459|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139460|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139461|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139462|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139463|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139464|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139465|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139466|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139661|NCT00462670|B2|Baseline|OPC-41061|15mg of OPC-41061 per day for 7days p.o. administration
1139662|NCT00462670|B1|Baseline|Placebo|0 mg of OPC-41061 per day for 7days p.o. administration
1139467|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139468|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139469|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139470|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139471|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139472|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139473|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139474|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139475|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
1139476|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
1139477|NCT00463047|E2|Reported Event|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug. This arm represents all subjects who had exposure to at least one dose of immediate-release oxycodone either during the titration periods or double-blind periods. 320 subjects were randomized to titrate either FBT or oxycodone. 39 subjects received only oxycodone before discontinuing leaving 281 who received FBT during the study. 36 subjects received only FBT before discontinuing, leaving only 284 who received oxycodone.
1139478|NCT00463047|E1|Reported Event|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients. This group includes all subjects in this study who had taken at least one dose of FBT in the course of the study, including both titration periods and both double-blind treatment periods. 320 subjects were randomized to titrate either FBT or oxycodone. 39 subjects received only oxycodone before discontinuing leaving 281 who received FBT during the study. 36 subjects received only FBT before discontinuing, leaving only 284 who received oxycodone.
1139479|NCT00462982|B1|Baseline|Sunitinib|Patients will be treated with 50 mg daily for four out of every six weeks.
1139480|NCT00462982|P1|Participant Flow|Sunitinib|Patients will be treated with 50 mg daily for four out of every six weeks.
1139481|NCT00462982|O1|Outcome|Sunitinib|Patients will be treated with 50 mg daily for four out of every six weeks.
1147687|NCT00441363|E1|Reported Event|Cycloset|0.8 mg tablet
1139484|NCT00462943|B3|Baseline|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139485|NCT00462943|B2|Baseline|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139486|NCT00462943|B1|Baseline|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139515|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139487|NCT00462943|P3|Participant Flow|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139488|NCT00462943|P2|Participant Flow|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139489|NCT00462943|P1|Participant Flow|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139490|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139491|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139492|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139493|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139494|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139495|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139496|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139703|NCT00462462|P2|Participant Flow|Absolute Ethanol Group|Patients who received one intralesional administration of Absolute Ethanol
1139497|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139498|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139499|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139500|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139772|NCT00462306|B3|Baseline|Total|Total of all reporting groups
1139501|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139502|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139503|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139504|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139505|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139506|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139507|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139508|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139509|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139567|NCT00462917|O1|Outcome|Pleiotropic Info, In-person Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment~Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during an in-person disclosure session."
1139510|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139511|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139512|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139513|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139514|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139887|NCT00462072|E3|Reported Event|Rheumatoid Arthritis (RA)|RA subjects taking Infliximab as part of their standard of care.
1139516|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139517|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139518|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139519|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139520|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139521|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139522|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139523|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139524|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1141943|NCT00456014|E1|Reported Event|1 - SSRI|Participants will take escitalopram.
1139525|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139526|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139527|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139528|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139529|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139888|NCT00462072|E2|Reported Event|Psoriatic Arthritis (PsA)|PsA subjects taking Infliximab as part of their standard of care.
1139530|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139531|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139532|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139533|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139534|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139535|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139536|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139537|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139538|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1141944|NCT00455975|B3|Baseline|Total|Total of all reporting groups
1139539|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139540|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139541|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139542|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139543|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139593|NCT00462839|O2|Outcome|Noncalibrated Drapes Viewed First|No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
1139544|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139545|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139546|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139547|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139548|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139549|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139550|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139551|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139568|NCT00462917|O4|Outcome|AD-only Info, In-person Disclosure|"Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment~AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
1139552|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139553|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139554|NCT00462943|E1|Reported Event|Omacetaxine|Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1139555|NCT00462917|B5|Baseline|Total|Total of all reporting groups
1139556|NCT00462917|B4|Baseline|AD-only Info, In-person Disclosure|"Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment~AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
1139557|NCT00462917|B3|Baseline|Pleiotropic Info, Phone Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment~Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during a telephone disclosure session."
1139558|NCT00462917|B2|Baseline|AD-only Info, Phone Disclosure|"Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment~AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
1139594|NCT00462839|O1|Outcome|Calibrated Vaginal Delivery Drapes Viewed First|Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
1139559|NCT00462917|B1|Baseline|Pleiotropic Info, In-person Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment~Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during an in-person disclosure session."
1139560|NCT00462917|P4|Participant Flow|AD-only Info, In-person Disclosure|"Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment~AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
1139561|NCT00462917|P3|Participant Flow|Pleiotropic Info, Phone Disclosure|"Incidental pleiotropic risk information, in addition to Alzheimer's disease risk information, is disclosed via telephone during an APOE-based genetic risk assessment~Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during a telephone disclosure session."
1139562|NCT00462917|P2|Participant Flow|AD-only Info, Phone Disclosure|"Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment~AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
1139563|NCT00462917|P1|Participant Flow|Pleiotropic Info, In-person Disclosure|"Incidental pleiotropic risk information, in addition to Alzheimer's disease risk information, is disclosed in-person during an APOE-based genetic risk assessment~Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during an in-person disclosure session."
1139564|NCT00462917|O4|Outcome|AD-only Info, In-person Disclosure|"Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment~AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
1139565|NCT00462917|O3|Outcome|Pleiotropic Info, Phone Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment~Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during a telephone disclosure session."
1139566|NCT00462917|O2|Outcome|AD-only Info, Phone Disclosure|"Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment~AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
1139585|NCT00462839|B2|Baseline|Noncalibrated Drapes Viewed First|No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
1142247|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
1139569|NCT00462917|O3|Outcome|Pleiotropic Info, Phone Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment~Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during a telephone disclosure session."
1139570|NCT00462917|O2|Outcome|AD-only Info, Phone Disclosure|"Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment~AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
1139571|NCT00462917|O1|Outcome|Pleiotropic Info, In-person Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment~Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during an in-person disclosure session."
1139572|NCT00462917|O4|Outcome|AD-only Info, In-person Disclosure|"Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment~AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
1139573|NCT00462917|O3|Outcome|Pleiotropic Info, Phone Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment~Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during a telephone disclosure session."
1139574|NCT00462917|O2|Outcome|AD-only Info, Phone Disclosure|"Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment~AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
1140254|NCT00461292|O3|Outcome|Placebo|Normal saline (placebo)
1139575|NCT00462917|O1|Outcome|Pleiotropic Info, In-person Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment~Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during an in-person disclosure session."
1139576|NCT00462917|E4|Reported Event|AD-only Info, In-person Disclosure|"Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment~AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
1139577|NCT00462917|E3|Reported Event|Pleiotropic Info, Phone Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment~Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during a telephone disclosure session."
1139578|NCT00462917|E2|Reported Event|AD-only Info, Phone Disclosure|"Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment~AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
1139579|NCT00462917|E1|Reported Event|Pleiotropic Info, In-person Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment~Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during an in-person disclosure session."
1139580|NCT00462865|B1|Baseline|Treatment|"After completion of neoadjuvant as well as surgical therapy the combination of gemcitabine/ Capecitabine and Avastin will be given for a total of six cycles.~Doses to be administered:~Gemcitabine 2000 mg/m2 on D1 Capecitabine 650 mg/m2 BID on D1-14 Avastin 15 mg/kg on D1~Following six cycles, patients will proceed to comprehensive breast radiation (if indicated) and will continue to receive avastin every 3 weeks during and after radiotherapy to complete 1 year of treatment."
1139581|NCT00462865|P1|Participant Flow|Gemcitabine, Capectiabine, Avastin|"After completion of neoadjuvant as well as surgical therapy the combination of gemcitabine/ Capecitabine and Avastin will be given for a total of six cycles.~Doses to be administered:~Gemcitabine 2000 mg/m2 on D1 Capecitabine 650 mg/m2 BID on D1-14 Avastin 15 mg/kg on D1~Following six cycles, patients will proceed to comprehensive breast radiation (if indicated) and will continue to receive avastin every 3 weeks during and after radiotherapy to complete 1 year of treatment."
1139582|NCT00462865|O1|Outcome|Gemcitabine, Capectiabine, Avastin|"After completion of neoadjuvant as well as surgical therapy the combination of gemcitabine/ Capecitabine and Avastin will be given for a total of six cycles that lead to patients being taken off study.~Doses to be administered:~Gemcitabine 2000 mg/m2 on D1 Capecitabine 650 mg/m2 BID on D1-14 Avastin 15 mg/kg on D1~Following six cycles, patients will proceed to comprehensive breast radiation (if indicated) and will continue to receive avastin every 3 weeks during and after radiotherapy to complete 1 year of treatment."
1139583|NCT00462865|E1|Reported Event|Gemcitabine, Capectiabine, Avastin|"After completion of neoadjuvant as well as surgical therapy the combination of gemcitabine/ Capecitabine and Avastin will be given for a total of six cycles.~Doses to be administered:~Gemcitabine 2000 mg/m2 on D1 Capecitabine 650 mg/m2 BID on D1-14 Avastin 15 mg/kg on D1~Following six cycles, patients will proceed to comprehensive breast radiation (if indicated) and will continue to receive avastin every 3 weeks during and after radiotherapy to complete 1 year of treatment."
1139584|NCT00462839|B3|Baseline|Total|Total of all reporting groups
1139586|NCT00462839|B1|Baseline|Calibrated Vaginal Delivery Drapes Viewed First|Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
1139587|NCT00462839|P2|Participant Flow|Noncalibrated Drapes Viewed First|No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
1139588|NCT00462839|P1|Participant Flow|Calibrated Vaginal Delivery Drapes Viewed First|Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
1139589|NCT00462839|O2|Outcome|Noncalibrated Drapes Viewed First|No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
1139590|NCT00462839|O1|Outcome|Calibrated Vaginal Delivery Drapes Viewed First|Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
1139591|NCT00462839|O2|Outcome|Noncalibrated Drapes Viewed First|No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
1139592|NCT00462839|O1|Outcome|Calibrated Vaginal Delivery Drapes Viewed First|Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
1139595|NCT00462839|O2|Outcome|Noncalibrated Drapes Viewed First|No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
1139596|NCT00462839|O1|Outcome|Calibrated Vaginal Delivery Drapes Viewed First|Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
1139597|NCT00462839|E2|Reported Event|Noncalibrated Drapes Viewed First|No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
1139598|NCT00462839|E1|Reported Event|Calibrated Vaginal Delivery Drapes Viewed First|Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
1139599|NCT00462826|B1|Baseline|Treatment (Aflibercept)|Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1139600|NCT00462826|P1|Participant Flow|Treatment (Aflibercept)|Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1139601|NCT00462826|O1|Outcome|Treatment (Aflibercept)|Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1139602|NCT00462826|E1|Reported Event|Treatment (Aflibercept)|Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1139603|NCT00462748|B4|Baseline|Total|Total of all reporting groups
1139604|NCT00462748|B3|Baseline|Rosuvastatin|rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally
1139605|NCT00462748|B2|Baseline|Atorvostatin|atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally
1139606|NCT00462748|B1|Baseline|Ezetimibe/Simvastatin|ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally
1139607|NCT00462748|P3|Participant Flow|Rosuvastatin|rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally
1139608|NCT00462748|P2|Participant Flow|Atorvostatin|atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally
1139609|NCT00462748|P1|Participant Flow|Ezetimibe/Simvastatin|ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally
1139610|NCT00462748|O3|Outcome|Rosuvastatin|rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally
1139611|NCT00462748|O2|Outcome|Atorvostatin|atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally
1139612|NCT00462748|O1|Outcome|Ezetimibe/Simvastatin|ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally
1139613|NCT00462748|E3|Reported Event|Rosuvastatin|rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally
1139614|NCT00462748|E2|Reported Event|Atorvostatin|atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally
1139615|NCT00462748|E1|Reported Event|Ezetimibe/Simvastatin|ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally
1139616|NCT00462722|B4|Baseline|Total|Total of all reporting groups
1139617|NCT00462722|B3|Baseline|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139687|NCT00462644|O1|Outcome|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
1139618|NCT00462722|B2|Baseline|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139619|NCT00462722|B1|Baseline|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139620|NCT00462722|P3|Participant Flow|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139621|NCT00462722|P2|Participant Flow|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139622|NCT00462722|P1|Participant Flow|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139654|NCT00462709|P1|Participant Flow|Open-label C1INH-nf|1,000 Units (U) of C1 esterase inhibitor (C1INH-nf) administered intravenously (IV) every 3 to 7 days.
1139623|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139624|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139625|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139626|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139627|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139628|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139629|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139630|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139631|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139688|NCT00462644|O2|Outcome|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
1139689|NCT00462644|O1|Outcome|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
1147688|NCT00441337|B5|Baseline|Total|Total of all reporting groups
1139632|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139633|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139634|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139635|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139636|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139637|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139655|NCT00462709|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 7 days.
1139638|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139639|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139640|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139641|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139642|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139643|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139644|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139645|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139646|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139647|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139648|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139649|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139650|NCT00462722|E3|Reported Event|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139651|NCT00462722|E2|Reported Event|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139652|NCT00462722|E1|Reported Event|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
1139653|NCT00462709|B1|Baseline|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 7 days.
1139663|NCT00462670|P2|Participant Flow|OPC-41061 15mg|"15mg OPC-41061~OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration"
1139664|NCT00462670|P1|Participant Flow|Placebo|"0mg~OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration"
1139665|NCT00462670|O2|Outcome|OPC-41061 15mg|"15mg OPC-41061~OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration"
1139666|NCT00462670|O1|Outcome|Placebo|"0mg~OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration"
1139667|NCT00462670|O2|Outcome|OPC-41061 15mg|"15mg OPC-41061~OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration"
1139668|NCT00462670|O1|Outcome|Placebo|"0mg~OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration"
1139669|NCT00462670|E2|Reported Event|OPC-41061 15mg|15 mg of OPC-41061 per day for 7days p.o. administration
1139670|NCT00462670|E1|Reported Event|Placebo|0 mg of OPC-41061 per day for 7days p.o. administration
1139671|NCT00462644|B3|Baseline|Total|Total of all reporting groups
1139672|NCT00462644|B2|Baseline|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
1139673|NCT00462644|B1|Baseline|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
1139674|NCT00462644|P2|Participant Flow|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
1139675|NCT00462644|P1|Participant Flow|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
1139676|NCT00462644|O2|Outcome|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
1139677|NCT00462644|O1|Outcome|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
1139678|NCT00462644|O2|Outcome|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
1139679|NCT00462644|O1|Outcome|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
1139680|NCT00462644|O2|Outcome|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
1139681|NCT00462644|O1|Outcome|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
1139682|NCT00462644|O2|Outcome|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
1139683|NCT00462644|O1|Outcome|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
1139684|NCT00462644|O2|Outcome|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
1139685|NCT00462644|O1|Outcome|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
1139686|NCT00462644|O2|Outcome|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
1139701|NCT00462462|B2|Baseline|Absolute Ethanol Group|Patients who received one intralesional administration of Absolute Ethanol
1139690|NCT00462644|E2|Reported Event|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
1139691|NCT00462644|E1|Reported Event|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
1139692|NCT00462605|B1|Baseline|Arm I|"Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria.~entinostat: Given PO~sargramostim: Given SC"
1139693|NCT00462605|P1|Participant Flow|Arm I|"Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria.~entinostat: Given PO~sargramostim: Given SC"
1139694|NCT00462605|O1|Outcome|Arm I|"Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria.~entinostat: Given PO~sargramostim: Given SC"
1139695|NCT00462605|E1|Reported Event|Arm I|"Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria.~entinostat: Given PO~sargramostim: Given SC"
1139696|NCT00462501|B1|Baseline|Chemotherapy and Bevacizumab With or Without Radiation|FOLFOX/Bevacizumab will be given for 4 cycles over 8 weeks; FOLFOLX6 without Bevacizumab will be given for an additional 2 cycles over 4 weeks. Oxaliplatin will be given on Day 1 of each cycle over 2 hours at 85 mg/m2 IV. Leucovorin will be given Day 1 of each cycle over 2 hours at 400 mg/m2 IV. Fluorouracil will be given on Day 1 of each cycle at 400 mg/m2 IVP, then Fluorouracil will be given at 1200 mg/m2 IVCI over Day 1 and 2. Bevacizumab will be given at 5mg/kg over 10 minutes on day 1. Patients will undergo re-staging within 3 weeks of completing their 6th cycle of FOLFOX. If the reassessment reveals that there has been no disease progression as compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection. If the surgical oncologist’s reassessment is that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous infusional 5-fluorouracil.
1139697|NCT00462501|P1|Participant Flow|Chemotherapy and Bevacizumab With or Without Radiation|FOLFOX/Bevacizumab will be given for 4 cycles over 8 weeks; FOLFOLX6 without Bevacizumab will be given for an additional 2 cycles over 4 weeks. Oxaliplatin will be given on Day 1 of each cycle over 2 hours at 85 mg/m2 IV. Leucovorin will be given Day 1 of each cycle over 2 hours at 400 mg/m2 IV. Fluorouracil will be given on Day 1 of each cycle at 400 mg/m2 IVP, then Fluorouracil will be given at 1200 mg/m2 IVCI over Day 1 and 2. Bevacizumab will be given at 5mg/kg over 10 minutes on day 1. Patients will undergo re-staging within 3 weeks of completing their 6th cycle of FOLFOX. If the reassessment reveals that there has been no disease progression as compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection. If the surgical oncologist’s reassessment is that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous infusional 5-fluorouracil.
1139698|NCT00462501|O1|Outcome|Chemotherapy and Bevacizumab With or Without Radiation|FOLFOX/Bevacizumab will be given for 4 cycles over 8 weeks; FOLFOLX6 without Bevacizumab will be given for an additional 2 cycles over 4 weeks. Oxaliplatin will be given on Day 1 of each cycle over 2 hours at 85 mg/m2 IV. Leucovorin will be given Day 1 of each cycle over 2 hours at 400 mg/m2 IV. Fluorouracil will be given on Day 1 of each cycle at 400 mg/m2 IVP, then Fluorouracil will be given at 1200 mg/m2 IVCI over Day 1 and 2. Bevacizumab will be given at 5mg/kg over 10 minutes on day 1. Patients will undergo re-staging within 3 weeks of completing their 6th cycle of FOLFOX. If the reassessment reveals that there has been no disease progression as compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection. If the surgical oncologist’s reassessment is that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous infusional 5-fluorouracil.
1139699|NCT00462501|E1|Reported Event|Chemotherapy and Bevacizumab With or Without Radiation|FOLFOX/Bevacizumab will be given for 4 cycles over 8 weeks; FOLFOLX6 without Bevacizumab will be given for an additional 2 cycles over 4 weeks. Oxaliplatin will be given on Day 1 of each cycle over 2 hours at 85 mg/m2 IV. Leucovorin will be given Day 1 of each cycle over 2 hours at 400 mg/m2 IV. Fluorouracil will be given on Day 1 of each cycle at 400 mg/m2 IVP, then Fluorouracil will be given at 1200 mg/m2 IVCI over Day 1 and 2. Bevacizumab will be given at 5mg/kg over 10 minutes on day 1. Patients will undergo re-staging within 3 weeks of completing their 6th cycle of FOLFOX. If the reassessment reveals that there has been no disease progression as compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection. If the surgical oncologist’s reassessment is that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous infusional 5-fluorouracil.
1139700|NCT00462462|B3|Baseline|Total|Total of all reporting groups
1139704|NCT00462462|P1|Participant Flow|L0122 Gel Group|Patients who received one intralesional administration of L0122 gel
1139705|NCT00462462|O2|Outcome|Absolute Ethanol Group|Patients who received one intralesional administration of Absolute Ethanol and for whom lesional volume measurements were available at screening and at study end
1139706|NCT00462462|O1|Outcome|L0122 Gel Group|Patients who received one intralesional administration of L0122 gel and for whom lesional volume measurements were available at screening and at study end
1139707|NCT00462462|O2|Outcome|Absolute Ethanol Group|Patients who received one intralesional administration of Absolute Ethanol and who had blood samples just before and during infusion procedure (one patient who received Absolute Ethanol was not sampled during infusion procedure).
1139708|NCT00462462|O1|Outcome|L0122 Gel Group|Patients who received one intralesional administration of L0122 gel and who had blood samples just before and during infusion procedure.
1139709|NCT00462462|E2|Reported Event|Absolute Ethanol Group|Patients who received one intralesional administration of Absolute Ethanol
1139710|NCT00462462|E1|Reported Event|L0122 Gel Group|Patients who received one intralesional administration of L0122 gel
1139711|NCT00462449|B3|Baseline|Total|Total of all reporting groups
1139712|NCT00462449|B2|Baseline|Chedoke-McMaster Assessment Hand Impairment 4-6 RTP + FES|In addition to appropriate therapy, this group will receive the FES device and be given instruction on how to complete specialized exercises utilizing this device.
1139713|NCT00462449|B1|Baseline|Chedoke-McMaster Assessment Hand Impairment 2, 3 - RTP Alone|Individuals randomized into this group will only receive specialized therapy associated with this population.
1139714|NCT00462449|P2|Participant Flow|Chedoke-McMaster Assessment Hand Impairment 4-6 RTP + FES|In addition to appropriate therapy, this group will receive the FES device and be given instruction on how to complete specialized exercises utilizing this device.
1139715|NCT00462449|P1|Participant Flow|Chedoke-McMaster Assessment Hand Impairment 2, 3 - RTP Alone|Individuals randomized into this group will only receive specialized therapy associated with this population.
1139716|NCT00462449|O2|Outcome|Repetitive Task Practice Alone|Individuals randomized to receive Repetitive Task Practice alone.
1139717|NCT00462449|O1|Outcome|FES and Repetitive Task Practice (RTP)|Individuals who were randomized to receive Functional Electrical Stimulation together with Repetitive Task Practice
1139718|NCT00462449|O2|Outcome|Repetitive Task Practice Alone|Individuals randomized to receive Repetitive Task Practice alone.
1139719|NCT00462449|O1|Outcome|FES and Repetitive Task Practice (RTP)|Individuals who were randomized to receive Functional Electrical Stimulation together with Repetitive Task Practice
1139720|NCT00462449|O2|Outcome|Repetitive Task Practice Alone|Individuals randomized to receive Repetitive Task Practice alone.
1139721|NCT00462449|O1|Outcome|FES and Repetitive Task Practice (RTP)|Individuals who were randomized to receive Functional Electrical Stimulation together with Repetitive Task Practice
1139722|NCT00462449|E2|Reported Event|Chedoke-McMaster Assessment Hand Impairment 4-6 RTP + FES|In addition to appropriate therapy, this group will receive the FES device and be given instruction on how to complete specialized exercises utilizing this device.
1139723|NCT00462449|E1|Reported Event|Chedoke-McMaster Assessment Hand Impairment 2, 3 - RTP Alone|Individuals randomized into this group will only receive specialized therapy associated with this population.
1139724|NCT00462423|B1|Baseline|Single Arm, Open Label|"Single Arm, Open Label trial of Abraxane and Avastin~Abraxane and Avastin : Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle; Avastin 10 mg/kg IV every 2 weeks (without rest period)."
1139725|NCT00462423|P1|Participant Flow|Single Arm, Open Label|"Single Arm, Open Label trial of Abraxane and Avastin~Abraxane and Avastin : Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle; Avastin 10 mg/kg IV every 2 weeks (without rest period)."
1139726|NCT00462423|O1|Outcome|Single Arm, Open Label|"Single Arm, Open Label trial of Abraxane and Avastin~Avastin: Avastin 10 mg/kg IV every 2 weeks (without rest period).~Abraxane: Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle."
1139727|NCT00462423|O1|Outcome|Single Arm, Open Label|"Single Arm, Open Label trial of Abraxane and Avastin~Abraxane and Avastin : Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle; Avastin 10 mg/kg IV every 2 weeks (without rest period)."
1139728|NCT00462423|O1|Outcome|Single Arm, Open Label|"Single Arm, Open Label trial of Abraxane and Avastin~Avastin: Avastin 10 mg/kg IV every 2 weeks (without rest period).~Abraxane: Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle."
1139729|NCT00462423|O1|Outcome|Single Arm, Open Label|"Single Arm, Open Label trial of Abraxane and Avastin~Abraxane and Avastin : Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle; Avastin 10 mg/kg IV every 2 weeks (without rest period)."
1139730|NCT00462423|E1|Reported Event|Single Arm, Open Label|"Single Arm, Open Label trial of Abraxane and Avastin~Abraxane and Avastin : Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle; Avastin 10 mg/kg IV every 2 weeks (without rest period)."
1139731|NCT00462384|B1|Baseline|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
1139732|NCT00462384|P1|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 micrograms per kilogram (mcg/kg) body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
1139733|NCT00462384|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
1139734|NCT00462384|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
1139834|NCT00462280|O2|Outcome|Two Matched Nevi Group - Placebo|"Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139735|NCT00462384|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
1139736|NCT00462384|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
1139737|NCT00462384|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
1139738|NCT00462384|E1|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
1139739|NCT00462345|B1|Baseline|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
1139773|NCT00462306|B2|Baseline|Non-Pregnant Population|The study group consisted of non-pregnant females, presenting to Northwestern Memorial Hospital for ambulatory surgery
1139889|NCT00462072|E1|Reported Event|Psoriasis (Ps)|Ps subjects taking Infliximab as part of their standard of care.
1139890|NCT00462020|B3|Baseline|Total|Total of all reporting groups
1139740|NCT00462345|P1|Participant Flow|Rituximab, Methotrexate|Participants received rituximab 1000 milligrams (mg), intravenously (IV), on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received methotrexate (MTX) 10 to 25 milligrams per week (mg/week), orally (PO) or parenterally, and folate at a stable dose of greater than or equal to (≥) 5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone less than or equal to (≤) 10 milligrams per day (mg/day), PO, OR equivalent corticosteroid, OR non-steroidal anti-inflammatory drugs (NSAIDs), PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
1139741|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
1139742|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
1139743|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
1139744|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
1139745|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
1139746|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
1139793|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139865|NCT00462228|O1|Outcome|Memantine|All subject scores for memantine regardless of sequence in the crossover design.
1139747|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
1139748|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
1139749|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
1139750|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
1139774|NCT00462306|B1|Baseline|Pregnant Population|The study group consisted of pregnant women, presenting to Prentice Women's Hospital of Northwestern Memorial Hospital for spontaneous labor, induction of labor, and scheduled cesarean delivery.
1139775|NCT00462306|P2|Participant Flow|Non-Pregnant Population|The study group consisted of non-pregnant females, presenting to Northwestern Memorial Hospital for ambulatory surgery
1140255|NCT00461292|O2|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
1139751|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
1139752|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
1139753|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
1139754|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
1139755|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
1139756|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
1139757|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
1139866|NCT00462228|O2|Outcome|Placebo|All subject scores for placebo regardless of sequence in the crossover design.
1139758|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
1139759|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
1139760|NCT00462345|E1|Reported Event|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
1139761|NCT00462332|B3|Baseline|Total|Total of all reporting groups
1139762|NCT00462332|B2|Baseline|Low Risk Patients|Category of risk will be defined according to biological features.
1139763|NCT00462332|B1|Baseline|High Risk Patientes|Category of risk will be defined according to biological features.
1139764|NCT00462332|P2|Participant Flow|Low Risk Patients|Category of risk will be defined according to biological features.
1139765|NCT00462332|P1|Participant Flow|High Risk Patientes|Category of risk will be defined according to biological features.
1139766|NCT00462332|O2|Outcome|Low Risk Patients|Category of risk will be defined according to biological features.
1139767|NCT00462332|O1|Outcome|High Risk Patientes|Category of risk will be defined according to biological features.
1139768|NCT00462332|O2|Outcome|High Risk Patients|
1139769|NCT00462332|O1|Outcome|Low Risk Patients|
1139770|NCT00462332|E2|Reported Event|Low Risk Patients|Category of risk will be defined according to biological features.
1139771|NCT00462332|E1|Reported Event|High Risk Patientes|Category of risk will be defined according to biological features.
1139776|NCT00462306|P1|Participant Flow|Pregnant Population|The study group consisted of pregnant women, presenting to Prentice Women's Hospital of Northwestern Memorial Hospital for spontaneous labor, induction of labor, and scheduled cesarean delivery.
1139777|NCT00462306|O2|Outcome|Negative Berlin Questionnaires|Pregnant Women with Results of Berlin Questionnaire not Indicative of Sleep Disordered Breathing
1139778|NCT00462306|O1|Outcome|Positive Berlin Questionaires|Pregnant Women with Berlin Questionnaire Responses Indicative of Sleep Disordered Breathing
1139779|NCT00462306|O2|Outcome|Non-Pregnant Women|Non-pregnant women undergoing a surgical procedure
1139780|NCT00462306|O1|Outcome|Pregnant Women|
1139781|NCT00462306|E2|Reported Event|Non-Pregnant Population|The study group consisted of non-pregnant females, presenting to Northwestern Memorial Hospital for ambulatory surgery
1139782|NCT00462306|E1|Reported Event|Pregnant Population|The study group consisted of pregnant women, presenting to Prentice Women's Hospital of Northwestern Memorial Hospital for spontaneous labor, induction of labor, and scheduled cesarean delivery.
1139783|NCT00462280|B5|Baseline|Total|Total of all reporting groups
1139784|NCT00462280|B4|Baseline|One Large Nevi Group-Placebo|"Patients with one large nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139785|NCT00462280|B3|Baseline|One Large Nevi Group-Lovastatin|"Patients with one large nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139786|NCT00462280|B2|Baseline|Two Matched Nevi Group-Placebo|"Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139787|NCT00462280|B1|Baseline|Two Matched Nevi Group-Lovastatin|"Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139788|NCT00462280|P4|Participant Flow|One Large Nevi Group - Placebo|"Patients who have one large nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139789|NCT00462280|P3|Participant Flow|One Large Nevi Group - Lovastatin|"Patients who have one large nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139790|NCT00462280|P2|Participant Flow|Two Matched Nevi Group - Placebo|"Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139791|NCT00462280|P1|Participant Flow|Two Matched Nevi Group - Lovastatin|"Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139792|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139867|NCT00462228|O1|Outcome|Memantine|All subject scores for memantine regardless of sequence in the crossover design.
1139794|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139795|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139796|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139797|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139798|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139799|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139800|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139801|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139802|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139803|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139804|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139805|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139806|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139807|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139808|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139809|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139810|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139811|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139812|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139813|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139868|NCT00462228|E3|Reported Event|No Treatment (Washout)|All 11 subjects completed a 4 week washout between memantine and placebo arms and a 4 week washout at the end of the study.
1139814|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139815|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139816|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139817|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139818|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139819|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139820|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139821|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139884|NCT00462072|O1|Outcome|Psoriariatic Arthritis (PsA)|PsA subjects taking Infliximab as part of their standard of care.
1139822|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139823|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139824|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139825|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139826|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139827|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139828|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139829|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139830|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139831|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139832|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139833|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139835|NCT00462280|O1|Outcome|Two Matched Nevi Group - Lovastatin|"Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139836|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139837|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139838|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139839|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139840|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139841|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm.~Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139885|NCT00462072|O2|Outcome|Rheumatoid Arthritis (RA)|RA subjects starting Infliximab as part of their standard of care.
1139886|NCT00462072|O1|Outcome|Psoriatic Arthritis (PsA)|PsA subjects starting Infliximab as part of their standard of care.
1139842|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139843|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139844|NCT00462280|O2|Outcome|Two Matched Nevi Group - Placebo|"Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139845|NCT00462280|O1|Outcome|Two Matched Nevi Group - Lovastatin|"Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139846|NCT00462280|E4|Reported Event|One Large Nevi Group-Placebo|Patients who have one large nevi receive placebo PO QD for up to 6 months
1139847|NCT00462280|E3|Reported Event|One Large Nevi Group-Lovastatin|Patients who have one large nevi received lovastatin PO QD for up to 6 months
1139848|NCT00462280|E2|Reported Event|Two Matched Nevi Group-Placebo|"Patients receive placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139849|NCT00462280|E1|Reported Event|Two Matched Nevi Group-Lovastatin|"Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
1139850|NCT00462228|B1|Baseline|Overall Study|All 11 baseline subjects completed the three periods of the study: memantine treatment, placebo treatment, and no treatment (washout period) in this crossover design.
1139851|NCT00462228|P1|Participant Flow|Overall Study|All 11 baseline subjects completed the three periods of the study: memantine treatment, placebo treatment, and no treatment (washout period) in this crossover design. Five subjects were randomized to begin the study by taking memantine and crossover to placebo; seven subjects began with placebo and crossed over to memantine.
1139852|NCT00462228|O2|Outcome|Placebo|All subject scores for placebo regardless of sequence in the crossover design.
1139853|NCT00462228|O1|Outcome|Memantine|All subject scores for memantine regardless of sequence in the crossover design.
1139854|NCT00462228|O2|Outcome|Placebo|All subject scores for placebo regardless of sequence in the crossover design.
1139855|NCT00462228|O1|Outcome|Memantine|All subject scores for memantine regardless of sequence in the crossover design.
1139856|NCT00462228|O2|Outcome|Placebo|All subject scores for placebo regardless of sequence in the crossover design.
1139857|NCT00462228|O1|Outcome|Memantine|All subject scores for memantine regardless of sequence in the crossover design.
1139858|NCT00462228|O2|Outcome|Placebo|All subject scores for placebo regardless of sequence in the crossover design.
1139859|NCT00462228|O1|Outcome|Memantine|All subject scores for memantine regardless of sequence in the crossover design.
1139860|NCT00462228|O2|Outcome|Placebo|All subject scores for placebo regardless of sequence in the crossover design.
1139861|NCT00462228|O1|Outcome|Memantine|All subject scores for memantine regardless of sequence in the crossover design.
1139862|NCT00462228|O2|Outcome|Placebo|All subject scores for placebo regardless of sequence in the crossover design.
1139863|NCT00462228|O1|Outcome|Memantine|All subject scores for memantine regardless of sequence in the crossover design.
1139864|NCT00462228|O2|Outcome|Placebo|All subject scores for placebo regardless of sequence in the crossover design.
1149007|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
1139869|NCT00462228|E2|Reported Event|Memantine|All 11 subjects completed 12 weeks of memantine treatment. Subjects were given 5 mg per day for 7 days, then 5 mg twice per day for 7 days, then 10 mg AM, 5 mg PM for 7 days, then 10 mg twice daily, as tablet form.
1139870|NCT00462228|E1|Reported Event|Placebo|All 11 subjects completed 12 weeks of placebo treatment. Subjects were given 5 mg per day for 7 days, then 5 mg twice per day for 7 days, then 10 mg AM, 5 mg PM for 7 days, then 10 mg twice daily, as tablet form.
1139871|NCT00462072|B4|Baseline|Total|Total of all reporting groups
1139872|NCT00462072|B3|Baseline|Psoriasis (Ps)|Ps subjects starting Infliximab
1139873|NCT00462072|B2|Baseline|Psoriatic Arthritis (PsA)|PsA subjects starting Infliximab
1139874|NCT00462072|B1|Baseline|Rheumatoid Arthritis (RA)|RA subject starting Infliximab
1139875|NCT00462072|P3|Participant Flow|Rheumatoid Arthritis (RA)|RA subjects taking Infliximab as part of their standard of care.
1139876|NCT00462072|P2|Participant Flow|Psoriatic Arthritis (PsA)|PsA subjects taking Infliximab as part of their standard of care.
1139877|NCT00462072|P1|Participant Flow|Psoriasis (Ps)|Ps subjects taking Infliximab as part of their standard of care.
1139878|NCT00462072|O1|Outcome|Psoriasis (Ps)|Ps subjects taking Infliximab as part of their standard of care.
1139879|NCT00462072|O1|Outcome|Psoriasis (Ps)|Ps subjects taking Infliximab as part of their standard of care.
1139880|NCT00462072|O1|Outcome|Psoriasis (Ps)|Ps subjects taking Infliximab as part of their standard of care.
1139881|NCT00462072|O2|Outcome|Rheumatoid Arthritis|RA subjects taking Infliximab as part of their standard of care.
1139882|NCT00462072|O1|Outcome|Psoriatic Arthritis (PsA)|PsA subjects taking Infliximab as part of their standard of care.
1139883|NCT00462072|O2|Outcome|Rheumatoid Arthritis (RA)|RA subjects taking Infliximab as part of their standard of care.
1140256|NCT00461292|O1|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
1139891|NCT00462020|B2|Baseline|IV and Oral Abx|home on oral antibiotics to complete 7 days of treatment when tolerating PO's
1139892|NCT00462020|B1|Baseline|IV Only|5 days of IV antibiotics after appendectomy
1139893|NCT00462020|P2|Participant Flow|IV and Oral Abx|home on oral antibiotics to complete 7 days of treatment when tolerating PO's
1139894|NCT00462020|P1|Participant Flow|IV Only|5 days of IV antibiotics after appendectomy
1139895|NCT00462020|O2|Outcome|IV and Oral Abx|home on oral antibiotics to complete 7 days of treatment when tolerating PO's
1139896|NCT00462020|O1|Outcome|IV Only|5 days of IV antibiotics after appendectomy
1139897|NCT00462020|E2|Reported Event|IV and Oral Abx|home on oral antibiotics to complete 7 days of treatment when tolerating PO's
1139898|NCT00462020|E1|Reported Event|IV Only|5 days of IV antibiotics after appendectomy
1139899|NCT00461981|B3|Baseline|Total|Total of all reporting groups
1139900|NCT00461981|B2|Baseline|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139901|NCT00461981|B1|Baseline|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139902|NCT00461981|P2|Participant Flow|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139903|NCT00461981|P1|Participant Flow|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139904|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139905|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139906|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139907|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139908|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139909|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139910|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139911|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139912|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139913|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139914|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139915|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139916|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139917|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139918|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139919|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139920|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139921|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139922|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139923|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139924|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139925|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139926|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139927|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139928|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139929|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139930|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139931|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139932|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139933|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139934|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139935|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139936|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139937|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139938|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139939|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139940|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139941|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139942|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139943|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139944|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139945|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139946|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139947|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139948|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139949|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139950|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139951|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139952|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139953|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139954|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139955|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139956|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139957|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139958|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139959|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139960|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139961|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139962|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139963|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139964|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139965|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139966|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139967|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139968|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139969|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139970|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139971|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139972|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139973|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139974|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139975|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139976|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139977|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139978|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139979|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139980|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139981|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139982|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139983|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139984|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139985|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139986|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139987|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139988|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139989|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139990|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139991|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139992|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139993|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139994|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139995|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139996|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139997|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1139998|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1139999|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1140000|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1140001|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1140002|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1140003|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1140004|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1140005|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1140006|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1140007|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1140008|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1140009|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1140010|NCT00461981|E2|Reported Event|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
1140011|NCT00461981|E1|Reported Event|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
1140012|NCT00461851|B1|Baseline|Chemotherapy Plus Sorafenib|"Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone~Gemcitabine: Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8.~Carboplatin: Carboplatin will be given on day 1 to an AUC of 5.~Sorafenib: Sorafenib will be administered orally daily on days 2-19 at 400 mg bid"
1140013|NCT00461851|P1|Participant Flow|Chemotherapy Plus Sorafenib|"Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone~Gemcitabine: Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8.~Carboplatin: Carboplatin will be given on day 1 to an AUC of 5.~Sorafenib: Sorafenib will be administered orally daily on days 2-19 at 400 mg bid"
1140014|NCT00461851|O1|Outcome|Chemotherapy Plus Sorafenib|"Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone~Gemcitabine: Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8.~Carboplatin: Carboplatin will be given on day 1 to an AUC of 5.~Sorafenib: Sorafenib will be administered orally daily on days 2-19 at 400 mg bid"
1140015|NCT00461851|E1|Reported Event|Chemotherapy Plus Sorafenib|"Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone~Gemcitabine: Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8.~Carboplatin: Carboplatin will be given on day 1 to an AUC of 5.~Sorafenib: Sorafenib will be administered orally daily on days 2-19 at 400 mg bid"
1140016|NCT00461786|B1|Baseline|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
1140017|NCT00461786|P1|Participant Flow|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
1140018|NCT00461786|O1|Outcome|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
1140019|NCT00461786|O1|Outcome|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
1140020|NCT00461786|O1|Outcome|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
1149008|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
1140021|NCT00461786|O1|Outcome|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
1140022|NCT00461786|O1|Outcome|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
1140023|NCT00461786|E1|Reported Event|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
1140024|NCT00461734|B3|Baseline|Total|Total of all reporting groups
1140025|NCT00461734|B2|Baseline|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site
1140026|NCT00461734|B1|Baseline|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site
1140027|NCT00461734|P2|Participant Flow|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site
1140028|NCT00461734|P1|Participant Flow|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site
1140029|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients effectively had RV high septal lead placement site (Per protocol cohort)
1140030|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients effectively had RV apical lead placement site (Per protocol cohort)
1140031|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
1140032|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
1140033|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site
1140034|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site
1140035|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients effectively had RV high septal lead placement site (Per protocol cohort)
1140036|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients effectively had RV apical lead placement site (Per protocol cohort)
1140257|NCT00461292|O3|Outcome|Placebo|Normal saline (placebo)
1140037|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to trat cohort)
1140038|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
1140039|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site
1140040|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site
1140041|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site
1140042|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site
1140043|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site
1140044|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site
1140045|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients effectively had RV high septal lead placement site (Per protocol cohort)
1140046|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients effectively had RV apical lead placement site (Per protocol cohort)
1140047|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
1140048|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
1140049|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients effectively had RV high septal lead placement site (Per protocol cohort)
1140050|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients effectively had RV apical lead placement site (Per protocol cohort)
1140051|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
1140052|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
1140053|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients effectively had RV high septal lead placement site (Per protocol cohort)
1140054|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients effectively had RV apical lead placement site (Per protocol cohort)
1140055|NCT00461734|O2|Outcome|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
1140056|NCT00461734|O1|Outcome|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
1140057|NCT00461734|E2|Reported Event|RV High Septum|RV lead placement site: Patients randomised to RV high septal lead placement site
1140058|NCT00461734|E1|Reported Event|RV Apex|RV lead placement site: Patients randomised to RV apical lead placement site
1140059|NCT00461708|B3|Baseline|Total|Total of all reporting groups
1140060|NCT00461708|B2|Baseline|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
1140061|NCT00461708|B1|Baseline|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
1140074|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade 0|Participants with a rash Grade 0 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
1140062|NCT00461708|P2|Participant Flow|Erlotinib, Gemcitabine: Rash Grade Greater Than/Equal to (≥) 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
1140063|NCT00461708|P1|Participant Flow|Erlotinib, Gemcitabine: Rash Grade Less Than (<) 2|Participants with a rash Grade < 2 according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version (V) 3.0 received erlotinib, 100 milligrams (mg), orally (PO), once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 milligrams per square meter (mg/m^2), intravenously (IV), over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
1140064|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
1140065|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
1140097|NCT00461682|O1|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
1140098|NCT00461682|O2|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
1140066|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
1140067|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
1140068|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
1140069|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
1140070|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
1140071|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
1140072|NCT00461708|O3|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
1140073|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade 1|Participants with a rash Grade 1 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
1149009|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
1140075|NCT00461708|O3|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
1140076|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade 1|Participants with a rash Grade 1 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
1140077|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade 0|Participants with a rash Grade 0 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
1140078|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
1140099|NCT00461682|O1|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
1140079|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
1140080|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
1140081|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
1140082|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
1140083|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
1140084|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
1140085|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
1140086|NCT00461708|E2|Reported Event|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
1140117|NCT00461630|P2|Participant Flow|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
1140118|NCT00461630|P1|Participant Flow|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
1140087|NCT00461708|E1|Reported Event|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
1140088|NCT00461682|B1|Baseline|Overall Study Arm|
1140089|NCT00461682|P1|Participant Flow|Total Population|Eligible participants were planned to receive oral SB-705498 eight hundred (800) milligrams (mg) once daily or matching Placebo in a randomized manner over two treatment periods once in the study. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
1140090|NCT00461682|O2|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
1140091|NCT00461682|O1|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
1140092|NCT00461682|O2|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
1140093|NCT00461682|O1|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
1140094|NCT00461682|O2|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
1140095|NCT00461682|O1|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
1140096|NCT00461682|O2|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
1140907|NCT00460239|O4|Outcome|Buprenorphine 8 mg|
1140100|NCT00461682|O2|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
1140101|NCT00461682|O1|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
1140102|NCT00461682|O2|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
1140103|NCT00461682|O1|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
1140104|NCT00461682|O2|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
1140105|NCT00461682|O1|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
1140106|NCT00461682|O2|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
1140107|NCT00461682|O1|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
1140108|NCT00461682|O2|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
1140109|NCT00461682|O1|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
1140110|NCT00461682|O2|Outcome|SB-705498|Participants were planned to receive oral SB-705498 800 mg once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
1140111|NCT00461682|O1|Outcome|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
1140112|NCT00461682|E2|Reported Event|SB-705498|Participants were planned to receive oral SB-705498 800 milligrams (mg) once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
1140113|NCT00461682|E1|Reported Event|Placebo|Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.
1140114|NCT00461630|B3|Baseline|Total|Total of all reporting groups
1140115|NCT00461630|B2|Baseline|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
1140116|NCT00461630|B1|Baseline|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
1149010|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
1140119|NCT00461630|O2|Outcome|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
1140120|NCT00461630|O1|Outcome|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
1140121|NCT00461630|O2|Outcome|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
1140122|NCT00461630|O1|Outcome|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
1140123|NCT00461630|O2|Outcome|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
1140124|NCT00461630|O1|Outcome|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
1140125|NCT00461630|O2|Outcome|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
1140126|NCT00461630|O1|Outcome|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
1140127|NCT00461630|O2|Outcome|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
1140128|NCT00461630|O1|Outcome|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
1140170|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
1140129|NCT00461630|E2|Reported Event|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
1140130|NCT00461630|E1|Reported Event|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
1140131|NCT00461513|B3|Baseline|Total|Total of all reporting groups
1140132|NCT00461513|B2|Baseline|Usual Care Group|Baseline characteristics of patients who enrolled and were randomized to the Usual Care Group, and who had at least one follow-up Kansas City Cardiomyopathy Questionnaire (at 3, 6, or 12 months).Therefore the total number completed in the Usual Care Arm was 172, but we had at least one follow-up Kansas City Cardiomyopathy Questionnaire result on 197 patients.
1140133|NCT00461513|B1|Baseline|Intervention Group|Baseline characteristics of patients who enrolled and were randomized to the Intervention Group, and who had at least one follow-up Kansas City Cardiomyopathy Questionnaire (at 3, 6, or 12 months). Therefore the total number completed in the Intervention Arm was 165, but we had at least one follow-up Kansas City Cardiomyopathy Questionnaire result on 187 patients.
1140134|NCT00461513|P2|Participant Flow|Usual Care|Patients randomized to the usual care arm continued to receive care at the discretion of their regular VA providers (for a given patient, this could include cardiology specialty care in addition to PCP care, participation in site-specific CHF programs such as CHF patient education classes, etc.), in direct continuity with the care they were receiving prior to enrollment. Patients in the usual care group were given information sheets that outlined self-care for CHF, and provided with a scale if needed at the enrollment visit. Patients in the usual care group had the same amount of interaction with the study team as the intervention patients (i.e. complete questionnaires at the same frequency; have the same study visits). PCPs of usual care patients were notified of the results of all screening studies (patient survey results, lab tests).
1140135|NCT00461513|P1|Participant Flow|Intervention|The PCDM intervention included evaluation of CHF care by the collaborative care (CC) team with treatment recommendations based on current ACC/AHA clinical practice guidelines, telemonitoring, and screening and treatment for comorbid depression. The CC team at each site included a primary care provider, cardiologist and psychiatrist, as well as nurse and pharmacist. For each intervention patient, there was initial assessment of care following the enrollment visit. Each intervention patient was re-reviewed by the CC team a minimum of 2 additional times (at 6-weeks and 6 months). In addition, patients had daily telemonitoring, and their care was reviewed if the telemonitoring data suggested clinical deterioration.
1140136|NCT00461513|O2|Outcome|Usual Care|
1140137|NCT00461513|O1|Outcome|Intervention|
1140138|NCT00461513|E2|Reported Event|Usual Care|
1140139|NCT00461513|E1|Reported Event|Intervention|
1140140|NCT00461500|B3|Baseline|Total|Total of all reporting groups
1140141|NCT00461500|B2|Baseline|FP 100: Fluticasone Propionate.|Analysis population used in this arm is ITT population(Randomised subjects who received at least one dose of study drug and with evaluation for at least one efficacy criteria).
1140142|NCT00461500|B1|Baseline|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|Analysis population used in this arm is ITT (intent-to-treat) population (Randomised subjects who received at least one dose of study drug and with evaluation for at least one efficacy criteria).
1140143|NCT00461500|P2|Participant Flow|FP (Fluticasone Propionate)100|Analysis population are all randomized subjects in this arm. 100ug - one inhalation twice daily
1140144|NCT00461500|P1|Participant Flow|SFC (Salmeterol Xinafoate/Fluticasone Propionate Combination)|Analysis population are all randomized subjects in this arm. 50/100ug - one inhalation twice daily
1140145|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
1140146|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
1140147|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
1140148|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
1140149|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
1140150|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
1140151|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
1140152|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
1140153|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
1140154|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
1140155|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
1140156|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
1140157|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
1140158|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
1140159|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
1140160|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
1140161|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
1140162|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
1140163|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
1140164|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
1140165|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
1140166|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
1140167|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
1140168|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
1140169|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
1140172|NCT00461500|E1|Reported Event|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
1140173|NCT00461331|B1|Baseline|Entire Study Population|These are the characteristics of the entire study population.
1140174|NCT00461331|P2|Participant Flow|Lispro First, Washout, Then Aspart|Patients used Lispro Insulin for up to 100 hours, then entered a two week wash out period, then used Aspart insulin for up to 100 hours. Patients used the insulin at the same dose that they were using prior to entering the study.
1140175|NCT00461331|P1|Participant Flow|Aspart First, Washout, Then Lispro|Patients used Aspart Insulin for up to 100 hours, then entered a two week wash out period, then used Lispro insulin for up to 100 hours. Patients used the insulin at the same dose that they were using prior to entering the study.
1140176|NCT00461331|O2|Outcome|Insulin Lispro|Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Lispro.
1140177|NCT00461331|O1|Outcome|Insulin Aspart|Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Aspart.
1140178|NCT00461331|O2|Outcome|Insulin Lispro|Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Lispro.
1140179|NCT00461331|O1|Outcome|Insulin Aspart|Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Aspart.
1140180|NCT00461331|O2|Outcome|Insulin Lispro|Patients were randomized to either insulin aspart or lispro first in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Lispro.
1140181|NCT00461331|O1|Outcome|Insulin Aspart|Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Aspart.
1140209|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140332|NCT00461032|O2|Outcome|Montelukast 5 mg|Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
1140182|NCT00461331|E2|Reported Event|Insulin Lispro|Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Lispro.
1140183|NCT00461331|E1|Reported Event|Insulin Aspart|Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Aspart.
1140184|NCT00461305|B3|Baseline|Total|Total of all reporting groups
1140185|NCT00461305|B2|Baseline|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140186|NCT00461305|B1|Baseline|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
1140187|NCT00461305|P2|Participant Flow|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140188|NCT00461305|P1|Participant Flow|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
1140189|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
1140190|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140258|NCT00461292|O2|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
1140191|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140192|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
1140193|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140194|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140195|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
1140196|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140197|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140198|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
1140199|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140200|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140201|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
1140202|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140203|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140204|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
1140205|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140206|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140207|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
1140208|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140210|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
1140211|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140212|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140213|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
1140214|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140215|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140216|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
1140217|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140218|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140219|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
1140259|NCT00461292|O1|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
1140260|NCT00461292|O3|Outcome|Placebo|Normal saline (placebo)
1140220|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140221|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140222|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
1140223|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140224|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140225|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
1140226|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140227|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140228|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
1140229|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140230|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140231|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
1140232|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140233|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140234|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
1140235|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140236|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140237|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
1140238|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140239|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140240|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
1140241|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140242|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140243|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140244|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140245|NCT00461305|E2|Reported Event|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
1140246|NCT00461305|E1|Reported Event|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
1140247|NCT00461292|B4|Baseline|Total|Total of all reporting groups
1140248|NCT00461292|B3|Baseline|Placebo|Normal saline (placebo)
1140249|NCT00461292|B2|Baseline|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
1140250|NCT00461292|B1|Baseline|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
1140251|NCT00461292|P3|Participant Flow|Placebo|Normal saline (placebo)
1140252|NCT00461292|P2|Participant Flow|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
1140253|NCT00461292|P1|Participant Flow|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
1140261|NCT00461292|O2|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
1140262|NCT00461292|O1|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
1140263|NCT00461292|O3|Outcome|Placebo|Normal saline (placebo)
1140264|NCT00461292|O2|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
1140265|NCT00461292|O1|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
1140266|NCT00461292|E3|Reported Event|Placebo|Normal saline (placebo)
1140267|NCT00461292|E2|Reported Event|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
1140268|NCT00461292|E1|Reported Event|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
1140269|NCT00461253|B3|Baseline|Total|Total of all reporting groups
1140270|NCT00461253|B2|Baseline|Controls|Controls were selected randomly from the national population registry (Finland) or via neighborhood controls by a controlled random route method (Germany).
1140271|NCT00461253|B1|Baseline|Cases|Cases were defined as women who were diagnosed with breast cancer (invasive carcinoma or carcinoma in situ) between 1/2000 and 12/2007 and aged <50 years at diagnosis.
1140272|NCT00461253|P2|Participant Flow|Controls|Controls were selected randomly from the national population registry (Finland) or via neighborhood controls by a controlled random route method (Germany).
1140273|NCT00461253|P1|Participant Flow|Cases|Cases were defined as women who were diagnosed with breast cancer (invasive carcinoma or carcinoma in situ) between 1/2000 and 12/2007 and aged <50 years at diagnosis.
1140274|NCT00461253|O2|Outcome|Cu-IUD|Women who currently or ever used a copper IUDs at time of breast cancer diagnosis
1140275|NCT00461253|O1|Outcome|LNG IUD|Women who currently or ever used a LNG IUDs (Mirena) at time of breast cancer diagnosis
1140276|NCT00461253|E2|Reported Event|Cu-IUD|Users of copper IUDs
1140277|NCT00461253|E1|Reported Event|LNG IUD|Users of LNG IUDs (Mirena)
1140278|NCT00461175|B3|Baseline|Total|Total of all reporting groups
1140279|NCT00461175|B2|Baseline|Copper IUD|New users of Copper IUD
1140280|NCT00461175|B1|Baseline|LNG IUS|New users of Mirena® IUS
1140281|NCT00461175|P2|Participant Flow|Copper IUD|New users of Copper IUD
1140282|NCT00461175|P1|Participant Flow|LNG IUS|New users of Mirena® IUS
1140283|NCT00461175|O2|Outcome|Copper IUD|New users of Copper IUD
1140284|NCT00461175|O1|Outcome|LNG IUS|New users of Mirena® IUS
1140285|NCT00461175|O2|Outcome|Copper IUD|New users of Copper IUD
1140286|NCT00461175|O1|Outcome|LNG IUS|New users of Mirena® IUS
1140287|NCT00461175|E2|Reported Event|Copper IUD|New users of Copper IUD
1140288|NCT00461175|E1|Reported Event|LNG IUS|New users of Mirena® IUS
1140289|NCT00461123|B3|Baseline|Total|Total of all reporting groups
1140290|NCT00461123|B2|Baseline|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
1140291|NCT00461123|B1|Baseline|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
1140292|NCT00461123|P2|Participant Flow|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
1140293|NCT00461123|P1|Participant Flow|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
1140294|NCT00461123|O2|Outcome|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
1144212|NCT00450073|B3|Baseline|Sunlamp|Use of a sunlamp 5 times a week for 12 weeks
1140295|NCT00461123|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
1140296|NCT00461123|O2|Outcome|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
1140297|NCT00461123|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
1140298|NCT00461123|O2|Outcome|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
1140299|NCT00461123|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
1140300|NCT00461123|O2|Outcome|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
1140301|NCT00461123|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
1140302|NCT00461123|O2|Outcome|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
1140303|NCT00461123|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
1140304|NCT00461123|E2|Reported Event|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
1140305|NCT00461123|E1|Reported Event|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
1140306|NCT00461097|B3|Baseline|Total|Total of all reporting groups
1140307|NCT00461097|B2|Baseline|Placebo|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
1140308|NCT00461097|B1|Baseline|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
1140309|NCT00461097|P2|Participant Flow|Placebo|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
1140310|NCT00461097|P1|Participant Flow|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
1140327|NCT00461032|B1|Baseline|Placebo|Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
1140328|NCT00461032|P2|Participant Flow|Montelukast 5 mg|Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
1140329|NCT00461032|P1|Participant Flow|Placebo|Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
1140311|NCT00461097|O1|Outcome|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
1140312|NCT00461097|O2|Outcome|Placebo|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
1140313|NCT00461097|O1|Outcome|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
1140348|NCT00460993|E1|Reported Event|Group 1|Active drug given in phase 1, then placebo pill given in phase 2.
1140349|NCT00460811|B6|Baseline|Total|Total of all reporting groups
1140908|NCT00460239|O3|Outcome|Morphine 30 mg|
1140314|NCT00461097|O2|Outcome|Placebo|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
1140315|NCT00461097|O1|Outcome|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
1140316|NCT00461097|O2|Outcome|Placebo|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
1140317|NCT00461097|O1|Outcome|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
1140330|NCT00461032|O2|Outcome|Montelukast 5 mg|Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
1140331|NCT00461032|O1|Outcome|Placebo|Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
1144213|NCT00450073|B2|Baseline|Vitamin D2|vitamin D2 50,000 IU weekly
1140318|NCT00461097|O2|Outcome|Placebo|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
1140319|NCT00461097|O1|Outcome|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
1140320|NCT00461097|O2|Outcome|Placebo|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
1140350|NCT00460811|B5|Baseline|Matching Placebo|Dose-matched placebo, oral administration, once per day
1140351|NCT00460811|B4|Baseline|579 µg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
1140352|NCT00460811|B3|Baseline|290 µg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
1140353|NCT00460811|B2|Baseline|145 µg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
1140354|NCT00460811|B1|Baseline|72 µg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
1140321|NCT00461097|O1|Outcome|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
1140322|NCT00461097|E3|Reported Event|Egg Oral Immunotherapy (OIT), 2-4 Years|"Subjects who failed the 1st or 2nd 10 gm OFC at month 22 or year 2 continue on their egg OIT maintenance dose of 2 gm/day of egg white solid (EWS) or are allowed to attempt escalation up to 2 gm/day for the remainder of the study. Subjects who are not considered tolerant may have a 10 gm OFC at year 3 and year 4 to assess desensitization. Subjects who pass the 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.~Note: The total number of subjects assessed for non-systematic adverse events was 36 (subjects with post 2-year follow-up) and for systematic adverse events was 22 (subjects with post 2-year dosing)."
1140323|NCT00461097|E2|Reported Event|Placebo, 0-2 Years|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
1140324|NCT00461097|E1|Reported Event|Egg Oral Immunotherapy (OIT), 0-2 Years|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day. A 10 gm OFC to identify desensitized [1] subjects occurs at month 22. Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC at year 2. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
1140325|NCT00461032|B3|Baseline|Total|Total of all reporting groups
1140326|NCT00461032|B2|Baseline|Montelukast 5 mg|Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
1140333|NCT00461032|O1|Outcome|Placebo|Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
1140334|NCT00461032|O2|Outcome|Montelukast 5 mg|Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
1140335|NCT00461032|O1|Outcome|Placebo|Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
1140336|NCT00461032|O2|Outcome|Montelukast 5 mg|Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
1140337|NCT00461032|O1|Outcome|Placebo|Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
1140338|NCT00461032|E2|Reported Event|Montelukast 5 mg|Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
1140339|NCT00461032|E1|Reported Event|Placebo|Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
1140340|NCT00460993|B3|Baseline|Total|Total of all reporting groups
1140341|NCT00460993|B2|Baseline|Group 2|"Sugar pill packaged and supplied by Sepracor. One pill weeks one and two of intervention.~Weeks 3 and 4 this Placebo group crosses over to active drug. 1 mg week 3 increasing to 2mg week 4 if sleep efficiency does not improve."
1140342|NCT00460993|B1|Baseline|Group 1|Lunesta Active drug (eszopiclone) 1 mg during 1st week of active drug. If sleep efficiency does not improve does increases to 2 mg for 2nd week of active drug administration.
1140343|NCT00460993|P2|Participant Flow|Group 2|Placebo during phase 1, then active drug phase 2. One placebo for 6 days
1140344|NCT00460993|P1|Participant Flow|Group 1|Active drug during phase 1, then placebo during phase 2. Lunesta Active drug (eszopiclone) 1 mg for 3 days. If sleep efficiency does not improve in 3 three day, dose increases to 2 mg for the next three days of active drug administration.
1140345|NCT00460993|O2|Outcome|Group 2|Placebo pill in phase 1, then Active drug given in phase 2. One placebo pill for 6 days
1140346|NCT00460993|O1|Outcome|Group 1|Active drug given in phase 1, then Placebo pill in phase 2. Lunesta Active drug (eszopiclone) 1 mg during three days of active drug. If sleep efficiency does not improve doses increases to 2 mg for the next three days of active drug administration.
1140347|NCT00460993|E2|Reported Event|Group 2|Placebo pill given in phase 1, then active drug give in phase 2. One placebo pill for 6 days.
1140355|NCT00460811|P5|Participant Flow|Matching Placebo|Dose-matched placebo, oral administration, once per day
1140356|NCT00460811|P4|Participant Flow|579 μg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
1140357|NCT00460811|P3|Participant Flow|290 μg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
1140358|NCT00460811|P2|Participant Flow|145 μg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
1140359|NCT00460811|P1|Participant Flow|72 μg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
1140360|NCT00460811|O5|Outcome|Matching Placebo|Dose-matched placebo, oral administration, once per day
1140361|NCT00460811|O4|Outcome|579 μg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
1140362|NCT00460811|O3|Outcome|290 μg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
1140363|NCT00460811|O2|Outcome|145 μg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
1140364|NCT00460811|O1|Outcome|72 μg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
1140365|NCT00460811|O5|Outcome|Matching Placebo|Dose-matched placebo, oral administration, once per day
1140366|NCT00460811|O4|Outcome|579 μg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
1140367|NCT00460811|O3|Outcome|290 μg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
1140368|NCT00460811|O2|Outcome|145 μg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
1140369|NCT00460811|O1|Outcome|72 μg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
1140370|NCT00460811|O5|Outcome|Matching Placebo|Dose-matched placebo, oral administration, once per day
1140371|NCT00460811|O4|Outcome|579 μg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
1140372|NCT00460811|O3|Outcome|290 μg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
1140373|NCT00460811|O2|Outcome|145 μg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
1140374|NCT00460811|O1|Outcome|72 μg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
1140375|NCT00460811|O5|Outcome|Matching Placebo|Dose-matched placebo, oral administration, once per day
1140376|NCT00460811|O4|Outcome|579 μg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
1140377|NCT00460811|O3|Outcome|290 μg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
1140378|NCT00460811|O2|Outcome|145 μg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
1140379|NCT00460811|O1|Outcome|72 μg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
1140380|NCT00460811|O5|Outcome|Matching Placebo|Dose-matched placebo, oral administration, once per day.
1140381|NCT00460811|O4|Outcome|579 ug Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
1140382|NCT00460811|O3|Outcome|290 ug Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
1140383|NCT00460811|O2|Outcome|145 ug Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
1140384|NCT00460811|O1|Outcome|72 ug Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
1140385|NCT00460811|O5|Outcome|Matching Placebo|Dose-matched placebo, oral administration, once per day.
1140386|NCT00460811|O4|Outcome|579 μg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
1140387|NCT00460811|O3|Outcome|290 μg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
1140388|NCT00460811|O2|Outcome|145 μg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
1140389|NCT00460811|O1|Outcome|72 μg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
1140390|NCT00460811|O5|Outcome|Matching Placebo|Dose-matched placebo, oral administration, once per day.
1140391|NCT00460811|O4|Outcome|579 ug Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
1140392|NCT00460811|O3|Outcome|290 ug Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
1140393|NCT00460811|O2|Outcome|145 ug Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
1140394|NCT00460811|O1|Outcome|72 ug Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
1140395|NCT00460811|E5|Reported Event|Matching Placebo|Dose-matched placebo, oral administration, once per day
1140396|NCT00460811|E4|Reported Event|579 µg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
1140397|NCT00460811|E3|Reported Event|290 µg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
1140398|NCT00460811|E2|Reported Event|145 µg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
1140399|NCT00460811|E1|Reported Event|72 µg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
1140400|NCT00460798|B1|Baseline|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
1140401|NCT00460798|P1|Participant Flow|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
1140402|NCT00460798|O1|Outcome|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
1140449|NCT00460655|O1|Outcome|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
1140403|NCT00460798|O1|Outcome|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
1140404|NCT00460798|O1|Outcome|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
1140405|NCT00460798|O1|Outcome|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
1140406|NCT00460798|O1|Outcome|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
1140407|NCT00460798|E1|Reported Event|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
1140408|NCT00460746|B1|Baseline|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
1140409|NCT00460746|P1|Participant Flow|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
1140410|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
1140411|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
1140412|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
1140413|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
1140414|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
1140415|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
1144214|NCT00450073|B1|Baseline|Vitamin D3|vitamin D3 50,000 IU weekly
1140416|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
1140417|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
1140418|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
1140419|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
1140420|NCT00460746|E1|Reported Event|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
1140421|NCT00460655|B3|Baseline|Total|Total of all reporting groups
1140422|NCT00460655|B2|Baseline|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
1140423|NCT00460655|B1|Baseline|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
1140424|NCT00460655|P4|Participant Flow|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
1140450|NCT00460655|O2|Outcome|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
1140425|NCT00460655|P3|Participant Flow|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
1140426|NCT00460655|P2|Participant Flow|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
1140427|NCT00460655|P1|Participant Flow|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
1140428|NCT00460655|O2|Outcome|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
1140429|NCT00460655|O1|Outcome|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
1140430|NCT00460655|O2|Outcome|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
1140431|NCT00460655|O1|Outcome|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
1140432|NCT00460655|O2|Outcome|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
1140433|NCT00460655|O1|Outcome|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
1140434|NCT00460655|O2|Outcome|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
1140435|NCT00460655|O1|Outcome|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
1140436|NCT00460655|O2|Outcome|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
1140995|NCT00459732|O2|Outcome|Placebo|daily capsule similar in size/color to zn was taken daily by this group
1140437|NCT00460655|O1|Outcome|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
1140438|NCT00460655|O2|Outcome|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
1140439|NCT00460655|O1|Outcome|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
1140440|NCT00460655|O2|Outcome|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
1140441|NCT00460655|O1|Outcome|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
1140442|NCT00460655|O2|Outcome|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
1140443|NCT00460655|O1|Outcome|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
1140444|NCT00460655|O2|Outcome|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
1140445|NCT00460655|O1|Outcome|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
1140446|NCT00460655|O2|Outcome|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
1140447|NCT00460655|O1|Outcome|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
1140448|NCT00460655|O2|Outcome|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
1140909|NCT00460239|O2|Outcome|Morphine 15 mg|
1140451|NCT00460655|O1|Outcome|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
1140452|NCT00460655|O2|Outcome|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
1140453|NCT00460655|O1|Outcome|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
1140454|NCT00460655|E4|Reported Event|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
1140455|NCT00460655|E3|Reported Event|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
1140456|NCT00460655|E2|Reported Event|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
1140457|NCT00460655|E1|Reported Event|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
1140458|NCT00460603|B13|Baseline|Total|Total of all reporting groups
1140459|NCT00460603|B12|Baseline|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140460|NCT00460603|B11|Baseline|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140461|NCT00460603|B10|Baseline|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140600|NCT00460564|P3|Participant Flow|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
1140601|NCT00460564|P2|Participant Flow|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140996|NCT00459732|O1|Outcome|Zinc|25 mg of zinc as zn sulfate taken daily
1140462|NCT00460603|B9|Baseline|Phase 1: Axitinib + FOLFIRI (Cohort 9)|Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140463|NCT00460603|B8|Baseline|Phase 1: Axitinib + FOLFIRI (Cohort 8)|Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 7 mg to 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140464|NCT00460603|B7|Baseline|Phase 1: Axitinib + FOLFOX (Cohort 7)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140465|NCT00460603|B6|Baseline|Phase 1: Axitinib + FOLFIRI (Cohort 6)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140678|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140723|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
1140910|NCT00460239|O1|Outcome|Placebo 0 mg|
1140466|NCT00460603|B5|Baseline|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140467|NCT00460603|B4|Baseline|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140468|NCT00460603|B3|Baseline|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 3)|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140469|NCT00460603|B2|Baseline|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 2)|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140479|NCT00460603|P4|Participant Flow|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140470|NCT00460603|B1|Baseline|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1)|Bevacizumab 1 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140471|NCT00460603|P12|Participant Flow|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140472|NCT00460603|P11|Participant Flow|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140473|NCT00460603|P10|Participant Flow|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140474|NCT00460603|P9|Participant Flow|Phase 1: Axitinib + FOLFIRI (Cohort 9)|Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140595|NCT00460564|P8|Participant Flow|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140475|NCT00460603|P8|Participant Flow|Phase 1: Axitinib + FOLFIRI (Cohort 8)|Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 7 mg to 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140476|NCT00460603|P7|Participant Flow|Phase 1: Axitinib + FOLFOX (Cohort 7)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140477|NCT00460603|P6|Participant Flow|Phase 1: Axitinib + FOLFIRI (Cohort 6)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140478|NCT00460603|P5|Participant Flow|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140997|NCT00459732|E2|Reported Event|Placebo|daily capsule similar in size/color to zn was taken daily by this group
1140480|NCT00460603|P3|Participant Flow|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 3)|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140481|NCT00460603|P2|Participant Flow|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 2)|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140482|NCT00460603|P1|Participant Flow|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1)|Bevacizumab 1 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 milligram per square meter (mg/m^2) intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-fluorouracil (5-FU) 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140483|NCT00460603|O3|Outcome|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140666|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140484|NCT00460603|O2|Outcome|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140485|NCT00460603|O1|Outcome|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140486|NCT00460603|O3|Outcome|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140487|NCT00460603|O2|Outcome|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140488|NCT00460603|O1|Outcome|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140602|NCT00460564|P1|Participant Flow|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140998|NCT00459732|E1|Reported Event|Zinc|25 mg of zinc as zn sulfate taken daily
1140489|NCT00460603|O3|Outcome|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140490|NCT00460603|O2|Outcome|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140491|NCT00460603|O1|Outcome|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140492|NCT00460603|O3|Outcome|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140493|NCT00460603|O2|Outcome|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140667|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140679|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140494|NCT00460603|O1|Outcome|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140495|NCT00460603|O3|Outcome|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140496|NCT00460603|O2|Outcome|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140497|NCT00460603|O1|Outcome|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140603|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140999|NCT00459706|B3|Baseline|Total|Total of all reporting groups
1140498|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140499|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140500|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140501|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140502|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140668|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
1140718|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
1140503|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140504|NCT00460603|O1|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140505|NCT00460603|O1|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140604|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140506|NCT00460603|O1|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140507|NCT00460603|O1|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140508|NCT00460603|O1|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140509|NCT00460603|O1|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140510|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140511|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140530|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140512|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140513|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140514|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140515|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140516|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140517|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140518|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140519|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140520|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140593|NCT00460564|B2|Baseline|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140594|NCT00460564|B1|Baseline|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140521|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140522|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140523|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140524|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140525|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140526|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140527|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140528|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140529|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140669|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140719|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
1140531|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140532|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140560|NCT00460603|O1|Outcome|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1149011|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
1140533|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140534|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140535|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140536|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140537|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140538|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140539|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1,2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140670|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140540|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140541|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1141000|NCT00459706|B2|Baseline|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1140542|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1,2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140543|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140544|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140545|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140546|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140547|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140548|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140671|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140672|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
1140549|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140550|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140551|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140552|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140553|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140554|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140555|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140556|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140557|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140673|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140674|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140558|NCT00460603|O3|Outcome|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140559|NCT00460603|O2|Outcome|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140561|NCT00460603|E12|Reported Event|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140562|NCT00460603|E11|Reported Event|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140563|NCT00460603|E10|Reported Event|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140564|NCT00460603|E9|Reported Event|Phase 1: Axitinib + FOLFOX (Cohort 9)|Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140565|NCT00460603|E8|Reported Event|Phase 1: Axitinib + FOLFIRI (Cohort 8)|Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 7 mg to 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140566|NCT00460603|E7|Reported Event|Phase 1: Axitinib + FOLFOX (Cohort 7)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140567|NCT00460603|E6|Reported Event|Phase 1: Axitinib + FOLFIRI (Cohort 6)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140720|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
1140568|NCT00460603|E5|Reported Event|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140569|NCT00460603|E4|Reported Event|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140598|NCT00460564|P5|Participant Flow|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1149012|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
1140570|NCT00460603|E3|Reported Event|Phase 1: Axitinib + FOLFOX + Bevacizumab (Cohort 3)|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140571|NCT00460603|E2|Reported Event|Phase 1: Axitinib + FOLFOX + Bevacizumab (Cohort 2)|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140572|NCT00460603|E1|Reported Event|Phase 1: Axitinib + FOLFOX + Bevacizumab (Cohort 1)|Bevacizumab 1 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
1140573|NCT00460577|B3|Baseline|Total|Total of all reporting groups
1140574|NCT00460577|B2|Baseline|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
1140575|NCT00460577|B1|Baseline|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
1140576|NCT00460577|P2|Participant Flow|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
1140577|NCT00460577|P1|Participant Flow|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
1140578|NCT00460577|O2|Outcome|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
1140579|NCT00460577|O1|Outcome|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
1140580|NCT00460577|O2|Outcome|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
1140581|NCT00460577|O1|Outcome|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
1140582|NCT00460577|O2|Outcome|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
1140583|NCT00460577|O1|Outcome|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
1140584|NCT00460577|O2|Outcome|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
1140585|NCT00460577|O1|Outcome|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
1140586|NCT00460577|O2|Outcome|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
1140587|NCT00460577|O1|Outcome|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
1140588|NCT00460577|E2|Reported Event|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
1140589|NCT00460577|E1|Reported Event|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
1140590|NCT00460564|B5|Baseline|Total|Total of all reporting groups
1140591|NCT00460564|B4|Baseline|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140592|NCT00460564|B3|Baseline|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
1140724|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
1140596|NCT00460564|P7|Participant Flow|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140597|NCT00460564|P6|Participant Flow|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140599|NCT00460564|P4|Participant Flow|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140651|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140605|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140606|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140607|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140608|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140609|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140610|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140611|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140675|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140863|NCT00460239|O8|Outcome|Buprenorphine 60 mg|
1140612|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140613|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140614|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140615|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140616|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140617|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140618|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140851|NCT00460265|E2|Reported Event|Chemotherapy Alone|
1140619|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140620|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140621|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140622|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140623|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140624|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140625|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140676|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
1140864|NCT00460239|O7|Outcome|Buprenorphine 48 mg|
1140865|NCT00460239|O6|Outcome|Buprenorphine 32 mg|
1140626|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140627|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140628|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140629|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140630|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140631|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140649|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140650|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140632|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140633|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140634|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140635|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140636|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140637|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140638|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140639|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140677|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140721|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
1140640|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140641|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140642|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140643|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140644|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
1140645|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140646|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140647|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140648|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
1140652|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
1140653|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140654|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140655|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140656|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
1140657|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140658|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140659|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140660|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
1140661|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140662|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140663|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140664|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
1140665|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140722|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
1140680|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
1140681|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140682|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140683|NCT00460564|O2|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140684|NCT00460564|O1|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
1140685|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140686|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140687|NCT00460564|E8|Reported Event|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140688|NCT00460564|E7|Reported Event|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140689|NCT00460564|E6|Reported Event|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140690|NCT00460564|E5|Reported Event|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
1140691|NCT00460564|E4|Reported Event|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140692|NCT00460564|E3|Reported Event|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
1140693|NCT00460564|E2|Reported Event|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140694|NCT00460564|E1|Reported Event|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
1140695|NCT00460551|B1|Baseline|Zalutumumab 8 mg/kg|
1140696|NCT00460551|P1|Participant Flow|Zalutumumab 8 mg/kg|
1140697|NCT00460551|O1|Outcome|Zalatumumab 8 mg/kg|
1140698|NCT00460551|O1|Outcome|Zalatumumab 8 mg/kg|
1140699|NCT00460551|E1|Reported Event|Zalutumumab 8 mg/kg|
1140700|NCT00460525|B3|Baseline|Total|Total of all reporting groups
1140701|NCT00460525|B2|Baseline|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
1140702|NCT00460525|B1|Baseline|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
1140703|NCT00460525|P2|Participant Flow|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
1140704|NCT00460525|P1|Participant Flow|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
1140705|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
1140706|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
1140707|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
1140708|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
1140709|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
1140710|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
1140711|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
1140712|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
1140713|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
1140714|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
1140715|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
1140716|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
1140717|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
1140866|NCT00460239|O5|Outcome|Buprenorphine 16 mg|
1140725|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
1140726|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
1140727|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
1140728|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
1140729|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
1140730|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
1140731|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
1140732|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
1140733|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
1140734|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
1140735|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
1140736|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
1140737|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
1140738|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
1140739|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
1140740|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
1140741|NCT00460525|E2|Reported Event|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
1140742|NCT00460525|E1|Reported Event|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
1140743|NCT00460421|B4|Baseline|Total|Total of all reporting groups
1140744|NCT00460421|B3|Baseline|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140745|NCT00460421|B2|Baseline|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140746|NCT00460421|B1|Baseline|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140747|NCT00460421|P3|Participant Flow|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140748|NCT00460421|P2|Participant Flow|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140749|NCT00460421|P1|Participant Flow|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140750|NCT00460421|O4|Outcome|All Subjects|All subjects from each age group (1-2, 3-11, 12-16 years)
1140751|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140852|NCT00460265|E1|Reported Event|Panitumumab Plus Chemotherapy|
1140752|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140753|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140754|NCT00460421|O4|Outcome|All Subjects|All subjects from each age group (1-2, 3-11, 12-16 years)
1140755|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140756|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140757|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140758|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140759|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140760|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140761|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140762|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140763|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140764|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140765|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140766|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140767|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140768|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140769|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140770|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140771|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140772|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140773|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140774|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140775|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140776|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140777|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140778|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140779|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140780|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140781|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140782|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140783|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140784|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140785|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140786|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140787|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140788|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140789|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140790|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
1140791|NCT00460421|E1|Reported Event|All Subjects|All subjects from each age group (1-2, 3-11, 12-16 years)
1140792|NCT00460408|B5|Baseline|Total|Total of all reporting groups
1140793|NCT00460408|B4|Baseline|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
1140794|NCT00460408|B3|Baseline|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
1140795|NCT00460408|B2|Baseline|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
1140796|NCT00460408|B1|Baseline|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
1140797|NCT00460408|P4|Participant Flow|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
1140798|NCT00460408|P3|Participant Flow|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
1140799|NCT00460408|P2|Participant Flow|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
1140800|NCT00460408|P1|Participant Flow|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
1140801|NCT00460408|O4|Outcome|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
1140802|NCT00460408|O3|Outcome|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
1140803|NCT00460408|O2|Outcome|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
1140867|NCT00460239|O4|Outcome|Buprenorphine 8 mg|
1140868|NCT00460239|O3|Outcome|Morphine 30 mg|
1140804|NCT00460408|O1|Outcome|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
1140805|NCT00460408|O4|Outcome|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
1140806|NCT00460408|O3|Outcome|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
1140807|NCT00460408|O2|Outcome|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
1140808|NCT00460408|O1|Outcome|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
1140809|NCT00460408|O4|Outcome|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
1140810|NCT00460408|O3|Outcome|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
1140811|NCT00460408|O2|Outcome|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
1140812|NCT00460408|O1|Outcome|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
1140813|NCT00460408|O4|Outcome|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
1140814|NCT00460408|O3|Outcome|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
1140815|NCT00460408|O2|Outcome|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
1140816|NCT00460408|O1|Outcome|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
1140817|NCT00460408|O1|Outcome|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
1140818|NCT00460408|O4|Outcome|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
1140819|NCT00460408|O3|Outcome|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
1140820|NCT00460408|O2|Outcome|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
1140821|NCT00460408|O1|Outcome|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
1140822|NCT00460408|O4|Outcome|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
1140823|NCT00460408|O3|Outcome|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
1140824|NCT00460408|O2|Outcome|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
1140825|NCT00460408|O1|Outcome|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
1140826|NCT00460408|O4|Outcome|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
1140827|NCT00460408|O3|Outcome|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
1140828|NCT00460408|O2|Outcome|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
1140829|NCT00460408|O1|Outcome|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
1140830|NCT00460408|E4|Reported Event|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
1140831|NCT00460408|E3|Reported Event|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
1140832|NCT00460408|E2|Reported Event|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
1140833|NCT00460408|E1|Reported Event|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
1140834|NCT00460265|B3|Baseline|Total|Total of all reporting groups
1140835|NCT00460265|B2|Baseline|Chemotherapy Alone|Consists of Cisplatin and 5-FU
1140836|NCT00460265|B1|Baseline|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
1140837|NCT00460265|P2|Participant Flow|Chemotherapy Alone|Consists of Cisplatin and 5-FU
1140838|NCT00460265|P1|Participant Flow|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
1140839|NCT00460265|O2|Outcome|Chemotherapy Alone|Consists of Cisplatin and 5-FU
1140840|NCT00460265|O1|Outcome|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
1140841|NCT00460265|O2|Outcome|Chemotherapy Alone|Consists of Cisplatin and 5-FU
1140842|NCT00460265|O1|Outcome|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
1140843|NCT00460265|O2|Outcome|Chemotherapy Alone|Consists of Cisplatin and 5-FU
1140844|NCT00460265|O1|Outcome|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
1140845|NCT00460265|O2|Outcome|Chemotherapy Alone|Consists of Cisplatin and 5-FU
1140846|NCT00460265|O1|Outcome|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
1140847|NCT00460265|O2|Outcome|Chemotherapy Alone|Consists of Cisplatin and 5-FU
1140848|NCT00460265|O1|Outcome|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
1140849|NCT00460265|O2|Outcome|Chemotherapy Alone|Consists of Cisplatin and 5-FU
1140850|NCT00460265|O1|Outcome|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
1140854|NCT00460239|P9|Participant Flow|Condition 9|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): M15, B8, B16, B32, M30, P, B48, B60.
1140855|NCT00460239|P8|Participant Flow|Condition 8|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): P, M30, M15, B8, B16, B32, B48, B60.
1140856|NCT00460239|P7|Participant Flow|Condition 7|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): M30, B8, P, B16, M15, B32, B48, B60.
1140857|NCT00460239|P6|Participant Flow|Condition 6|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): M15, P, B8, M30, B16, B32, P, B48, B60.
1140858|NCT00460239|P5|Participant Flow|Condition 5|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): B8, B16, M30, B32, P, B48, M15, B60.
1140859|NCT00460239|P4|Participant Flow|Condition 4|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): B8, M15, B16, P, B32, M30, B48, B60.
1140860|NCT00460239|P3|Participant Flow|Condition 3|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): B8, B16, B32, B48, M30, B60, P, M15.
1140861|NCT00460239|P2|Participant Flow|Condition 2|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): B8, B16, B32, M15, B48, P, B60, M30.
1140862|NCT00460239|P1|Participant Flow|Condition 1|Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): B8, B16, B32, B48, B60, M15, M30, P.
1140911|NCT00460239|O8|Outcome|Buprenorphine 60 mg|
1140912|NCT00460239|O7|Outcome|Buprenorphine 48 mg|
1140913|NCT00460239|O6|Outcome|Buprenorphine 32 mg|
1140914|NCT00460239|O5|Outcome|Buprenorphine 16 mg|
1140915|NCT00460239|O4|Outcome|Buprenorphine 8 mg|
1140916|NCT00460239|O3|Outcome|Morphine 30 mg|
1140917|NCT00460239|O2|Outcome|Morphine 15 mg|
1140918|NCT00460239|O1|Outcome|Placebo 0 mg|
1140919|NCT00460239|O8|Outcome|Buprenorphine 60 mg|
1140920|NCT00460239|O7|Outcome|Buprenorphine 48 mg|
1140921|NCT00460239|O6|Outcome|Buprenorphine 32 mg|
1140922|NCT00460239|O5|Outcome|Buprenorphine 16 mg|
1140923|NCT00460239|O4|Outcome|Buprenorphine 8 mg|
1140924|NCT00460239|O3|Outcome|Morphine 30 mg|
1140925|NCT00460239|O2|Outcome|Morphine 15 mg|
1140926|NCT00460239|O1|Outcome|Placebo 0 mg|
1140927|NCT00460239|E3|Reported Event|Buprenorphine Intervention|
1140928|NCT00460239|E2|Reported Event|Morphine Intervention|
1140929|NCT00460239|E1|Reported Event|Placebo Intervention|
1140930|NCT00460109|B1|Baseline|Rituximab + Denileukin Diftitox|Patients receive 375 mg/m^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
1140931|NCT00460109|P1|Participant Flow|Rituximab + Denileukin Diftitox|Patients receive 375 mg/m^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
1140932|NCT00460109|O1|Outcome|Rituximab + Denileukin Diftitox|Patients receive 375 mg/m^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
1140933|NCT00460109|O1|Outcome|Rituximab + Denileukin Diftitox|Patients receive 375 mg/m^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
1140934|NCT00460109|O1|Outcome|Rituximab + Denileukin Diftitox|Patients receive 375 mg/m^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
1140935|NCT00460109|O1|Outcome|Rituximab + Denileukin Diftitox|Patients receive 375 mg/m^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
1140936|NCT00460109|O1|Outcome|Rituximab + Denileukin Diftitox|Patients receive 375 mg/m^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
1141001|NCT00459706|B1|Baseline|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1140937|NCT00460109|E1|Reported Event|Rituximab + Denileukin Diftitox|Patients receive 375 mg/m^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
1140938|NCT00460031|B1|Baseline|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
1140939|NCT00460031|P1|Participant Flow|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
1140940|NCT00460031|O1|Outcome|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
1140941|NCT00460031|O1|Outcome|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
1140942|NCT00460031|O1|Outcome|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
1140943|NCT00460031|O1|Outcome|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
1140944|NCT00460031|O1|Outcome|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
1140945|NCT00460031|E1|Reported Event|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
1140946|NCT00459979|B1|Baseline|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
1141273|NCT00459316|O2|Outcome|Group 1 (CD4%≥25)|Participants ≥11 to <25 years with CD4%≥25
1140947|NCT00459979|P1|Participant Flow|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
1140948|NCT00459979|O1|Outcome|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
1140949|NCT00459979|O1|Outcome|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
1140950|NCT00459979|O1|Outcome|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
1140951|NCT00459979|O1|Outcome|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
1140952|NCT00459979|O1|Outcome|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
1140953|NCT00459979|O1|Outcome|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
1140954|NCT00459979|O1|Outcome|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
1140955|NCT00459979|E1|Reported Event|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
1140956|NCT00459953|B3|Baseline|Total|Total of all reporting groups
1140957|NCT00459953|B2|Baseline|Control Group|All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The control group received monthly follow-up phone calls for assessment purposes and to control for potential therapeutic effects associated with continued contact
1140958|NCT00459953|B1|Baseline|Extended Treatment|"extended cognitive behavioral treatment for smoking cessation; Participants receive an additional 9 sessions of cognitive behavior therapy~Extended treatment: All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training."
1140959|NCT00459953|P2|Participant Flow|Control Group|All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The control group received monthly follow-up phone calls for assessment purposes and to control for potential therapeutic effects associated with continued contact
1140960|NCT00459953|P1|Participant Flow|Extended Treatment|"extended cognitive behavioral treatment for smoking cessation; Participants receive an additional 9 sessions of cognitive behavior therapy~Extended treatment: All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training."
1140961|NCT00459953|O2|Outcome|Control Group|Monthly follow-up phone calls for assessment purposes and to control for potential therapeutic effects associated with continued contact
1140962|NCT00459953|O1|Outcome|Extended Treatment|"extended cognitive behavioral treatment for smoking cessation; Participants receive an additional 9 sessions of cognitive behavior therapy~Extended treatment: All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training."
1141002|NCT00459706|P2|Participant Flow|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1140963|NCT00459953|E2|Reported Event|Control Group|All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The control group received monthly follow-up phone calls for assessment purposes and to control for potential therapeutic effects associated with continued contact
1140964|NCT00459953|E1|Reported Event|Extended Treatment|"extended cognitive behavioral treatment for smoking cessation; Participants receive an additional 9 sessions of cognitive behavior therapy~Extended treatment: All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training."
1140965|NCT00459875|B1|Baseline|Sunitinib|"The treatment will include Sunitinib malate 50 mg self-administered orally, once daily in the evening, without regard to meals, for 4 consecutive weeks (28 days) followed by 2 weeks (14 days) off, to comprise a complete cycle of 6 weeks.~sunitinib malate"
1140966|NCT00459875|P1|Participant Flow|Sunitinib|"The treatment will include Sunitinib malate 50 mg self-administered orally, once daily in the evening, without regard to meals, for 4 consecutive weeks (28 days) followed by 2 weeks (14 days) off, to comprise a complete cycle of 6 weeks.~sunitinib malate"
1140967|NCT00459875|O1|Outcome|Sunitinib|"The treatment will include Sunitinib malate 50 mg self-administered orally, once daily in the evening, without regard to meals, for 4 consecutive weeks (28 days) followed by 2 weeks (14 days) off, to comprise a complete cycle of 6 weeks.~sunitinib malate"
1140968|NCT00459875|E1|Reported Event|Sunitinib|"The treatment will include Sunitinib malate 50 mg self-administered orally, once daily in the evening, without regard to meals, for 4 consecutive weeks (28 days) followed by 2 weeks (14 days) off, to comprise a complete cycle of 6 weeks.~sunitinib malate"
1140969|NCT00459862|B1|Baseline|Arm I|Patients receive oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
1140970|NCT00459862|P1|Participant Flow|Arm I|Patients receive 800mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
1140971|NCT00459862|O1|Outcome|Arm I|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
1140972|NCT00459862|O1|Outcome|Arm I|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
1140973|NCT00459862|O1|Outcome|Arm I|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
1140974|NCT00459862|O1|Outcome|Arm I|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
1140975|NCT00459862|O1|Outcome|Arm I|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
1140976|NCT00459862|O1|Outcome|Arm I|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
1140977|NCT00459862|E1|Reported Event|Arm I|Patients receive oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
1140978|NCT00459810|B1|Baseline|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
1140979|NCT00459810|P1|Participant Flow|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
1140980|NCT00459810|O1|Outcome|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
1140981|NCT00459810|O1|Outcome|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
1140982|NCT00459810|O1|Outcome|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
1140983|NCT00459810|O1|Outcome|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
1140984|NCT00459810|O1|Outcome|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
1140985|NCT00459810|E1|Reported Event|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
1140986|NCT00459732|B3|Baseline|Total|Total of all reporting groups
1140987|NCT00459732|B2|Baseline|Placebo|daily capsule similar in size/color to zn was taken daily by this group
1140988|NCT00459732|B1|Baseline|Zinc|25 mg of zinc as zn sulfate taken daily
1140989|NCT00459732|P2|Participant Flow|Placebo|daily capsule similar in size/color to zn was taken daily by this group
1140990|NCT00459732|P1|Participant Flow|Zinc|25 mg of zinc as zn sulfate taken daily
1140991|NCT00459732|O2|Outcome|Placebo|daily capsule similar in size/color to zn was taken daily by this group
1140992|NCT00459732|O1|Outcome|Zinc|25 mg of zinc as zn sulfate taken daily
1140993|NCT00459732|O2|Outcome|Placebo|daily capsule similar in size/color to zn was taken daily by this group
1140994|NCT00459732|O1|Outcome|Zinc|25 mg of zinc as zn sulfate taken daily
1141003|NCT00459706|P1|Participant Flow|Enbrel 50 mg Autoinjector|Enbrel 50 milligram (mg) once weekly subcutaneously for 12 Weeks using autoinjector
1141004|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141005|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141006|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141007|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141008|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141009|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141010|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141011|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141012|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141013|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141014|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141015|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141016|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141017|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141018|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141019|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141020|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141907|NCT00456521|O2|Outcome|Placebo|Placebo
1141021|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141022|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141023|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141024|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141025|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141026|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141027|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141028|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141029|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141030|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141031|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141032|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141033|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141034|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141035|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141036|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141037|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141038|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141039|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141040|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141041|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141042|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141043|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141044|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141045|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141046|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141047|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141048|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141049|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141050|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141051|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141052|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141053|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141054|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141055|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141056|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141057|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141058|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141059|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141060|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141061|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141062|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141063|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141064|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141065|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141066|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141067|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141068|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141069|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141070|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141071|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141072|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141073|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141074|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141075|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141076|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141077|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141078|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141079|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141080|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141081|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141082|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141083|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141084|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141085|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141086|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141087|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141088|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141089|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141090|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141091|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141092|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141093|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141094|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141095|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141096|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141097|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141098|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141099|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141100|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141101|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141102|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141103|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141104|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141105|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141106|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141107|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141108|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141109|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141110|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141111|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141112|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141113|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141114|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141115|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141116|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141117|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141118|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141119|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141120|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141121|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141122|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141123|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141124|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141125|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141126|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141127|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141128|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141129|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141130|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141131|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141132|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141133|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141134|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141135|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141136|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141137|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141138|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141139|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141140|NCT00459706|E2|Reported Event|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
1141141|NCT00459706|E1|Reported Event|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
1141142|NCT00459667|B4|Baseline|Total|Total of all reporting groups
1141143|NCT00459667|B3|Baseline|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day~*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
1141144|NCT00459667|B2|Baseline|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
1141145|NCT00459667|B1|Baseline|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
1141146|NCT00459667|P3|Participant Flow|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day~*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
1141147|NCT00459667|P2|Participant Flow|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
1141148|NCT00459667|P1|Participant Flow|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
1141149|NCT00459667|O3|Outcome|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day~*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
1141150|NCT00459667|O2|Outcome|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
1141151|NCT00459667|O1|Outcome|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
1141152|NCT00459667|O3|Outcome|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day~*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
1141153|NCT00459667|O2|Outcome|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
1141154|NCT00459667|O1|Outcome|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
1141155|NCT00459667|O3|Outcome|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day~*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
1141156|NCT00459667|O2|Outcome|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
1141157|NCT00459667|O1|Outcome|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
1141158|NCT00459667|O3|Outcome|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day~*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
1141159|NCT00459667|O2|Outcome|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
1141160|NCT00459667|O1|Outcome|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
1141161|NCT00459667|O3|Outcome|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day~*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
1141162|NCT00459667|O2|Outcome|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
1141163|NCT00459667|O1|Outcome|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
1141164|NCT00459667|E3|Reported Event|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day~*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
1141165|NCT00459667|E2|Reported Event|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
1141274|NCT00459316|O1|Outcome|Group 1 (15<CD4%<25)|Participants ≥11 to <25 years with 15<CD4%≤25
1141166|NCT00459667|E1|Reported Event|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
1141167|NCT00459537|B3|Baseline|Total|Total of all reporting groups
1141168|NCT00459537|B2|Baseline|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
1141169|NCT00459537|B1|Baseline|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
1141170|NCT00459537|P2|Participant Flow|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
1141171|NCT00459537|P1|Participant Flow|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
1141172|NCT00459537|O2|Outcome|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
1141173|NCT00459537|O1|Outcome|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
1141174|NCT00459537|O2|Outcome|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
1141175|NCT00459537|O1|Outcome|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
1141176|NCT00459537|O2|Outcome|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
1141177|NCT00459537|O1|Outcome|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
1141178|NCT00459537|O2|Outcome|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
1141179|NCT00459537|O1|Outcome|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
1141180|NCT00459537|O2|Outcome|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
1141181|NCT00459537|O1|Outcome|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
1141182|NCT00459537|E2|Reported Event|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
1141183|NCT00459537|E1|Reported Event|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
1141184|NCT00459381|B1|Baseline|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~pazopanib hydrochloride: Given orally~laboratory biomarker analysis: Correlative studies"
1141185|NCT00459381|P1|Participant Flow|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~pazopanib hydrochloride: Given orally~laboratory biomarker analysis: Correlative studies"
1141245|NCT00459316|O2|Outcome|Week 28|Group 2 participants at Week 28 (4 weeks after second vaccination)
1141246|NCT00459316|O1|Outcome|Week 4|Group 2 participants at Week 4
1141186|NCT00459381|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~pazopanib hydrochloride: Given orally~laboratory biomarker analysis: Correlative studies"
1141187|NCT00459381|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~pazopanib hydrochloride: Given orally~laboratory biomarker analysis: Correlative studies"
1141188|NCT00459381|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~pazopanib hydrochloride: Given orally~laboratory biomarker analysis: Correlative studies"
1141189|NCT00459381|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~pazopanib hydrochloride: Given orally~laboratory biomarker analysis: Correlative studies"
1141190|NCT00459381|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~pazopanib hydrochloride: Given orally~laboratory biomarker analysis: Correlative studies"
1141191|NCT00459381|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~pazopanib hydrochloride: Given orally~laboratory biomarker analysis: Correlative studies"
1141192|NCT00459381|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~pazopanib hydrochloride: Given orally~laboratory biomarker analysis: Correlative studies"
1141193|NCT00459381|E1|Reported Event|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Other: laboratory biomarker analysis~pazopanib hydrochloride: Given orally~laboratory biomarker analysis: Correlative studies"
1141194|NCT00459368|B3|Baseline|Total|Total of all reporting groups
1141275|NCT00459316|O4|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
1141195|NCT00459368|B2|Baseline|Usual Care|Physician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software.
1141196|NCT00459368|B1|Baseline|Patient Medication Adherence Feedback|In this cluster-randomized trial physicians practicing at intervention clinic sites will receive adherence information on their patients with asthma who are currently taking an inhaled corticosteroid medication. This information will be available to them via our electronic prescribing software to discuss with patients at the time of the visit. Physicians at these sites also receive standardized training in how to interpret and intervene when poor adherence is identified.
1141197|NCT00459368|P2|Participant Flow|Usual Care|Physician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software.
1141198|NCT00459368|P1|Participant Flow|Patient Medication Adherence Feedback|In this cluster-randomized trial physicians practicing at intervention clinic sites will receive adherence information on their patients with asthma who are currently taking an inhaled corticosteroid medication. This information will be available to them via our electronic prescribing software to discuss with patients at the time of the visit. Physicians at these sites also receive standardized training in how to interpret and intervene when poor adherence is identified.
1141199|NCT00459368|O2|Outcome|Usual Care|Physician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software.
1141200|NCT00459368|O1|Outcome|Patient Medication Adherence Feedback|In this cluster-randomized trial physicians practicing at intervention clinic sites will receive adherence information on their patients with asthma who are currently taking an inhaled corticosteroid medication. This information will be available to them via our electronic prescribing software to discuss with patients at the time of the visit. Physicians at these sites also receive standardized training in how to interpret and intervene when poor adherence is identified.
1141201|NCT00459368|E2|Reported Event|Usual Care|Physician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software.
1141202|NCT00459368|E1|Reported Event|Patient Medication Adherence Feedback|In this cluster-randomized trial physicians practicing at intervention clinic sites will receive adherence information on their patients with asthma who are currently taking an inhaled corticosteroid medication. This information will be available to them via our electronic prescribing software to discuss with patients at the time of the visit. Physicians at these sites also receive standardized training in how to interpret and intervene when poor adherence is identified.
1141203|NCT00459355|B3|Baseline|Total|Total of all reporting groups
1141204|NCT00459355|B2|Baseline|Checklist|Received conventional home safety checklist
1141205|NCT00459355|B1|Baseline|Home Safety Toolkit|"Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.~Home Safety Toolkit: Health literacy-verified booklet and home safety items to promote competence to make home safety modifications."
1141206|NCT00459355|P2|Participant Flow|Checklist|Group receives conventional home safety checklist
1141207|NCT00459355|P1|Participant Flow|Home Safety Toolkit|"Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.~Home Safety Toolkit: Health literacy-verified booklet and home safety items to promote competence to make home safety modifications."
1141208|NCT00459355|O2|Outcome|Conventional Safety Checklist|Comparison group received a conventional home safety checklist
1141247|NCT00459316|O3|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
1141209|NCT00459355|O1|Outcome|Home Safety Toolkit|"Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.~Home Safety Toolkit: Health literacy-verified booklet and home safety items to promote competence to make home safety modifications."
1141210|NCT00459355|O2|Outcome|Checklist|Conventional home safety checklist
1141211|NCT00459355|O1|Outcome|Home Safety Toolkit|"Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.~Home Safety Toolkit: Health literacy-verified booklet and home safety items to promote competence to make home safety modifications."
1141212|NCT00459355|O2|Outcome|Checklist|non-intervention group received conventional home safety checklist
1141213|NCT00459355|O1|Outcome|Home Safety Toolkit|"Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.~Home Safety Toolkit: Health literacy-verified booklet and home safety items to promote competence to make home safety modifications."
1141214|NCT00459355|E4|Reported Event|Checklist:Caregivers|Control group receives conventional list of home safety recommendations
1141215|NCT00459355|E3|Reported Event|Home Safety Toolkit:Caregivers|Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.
1141216|NCT00459355|E2|Reported Event|Checklist:Care Recipients|Control group receives conventional list of home safety recommendations
1141217|NCT00459355|E1|Reported Event|Home Safety Toolkit:Care Recipients|"Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.~Home Safety Toolkit: Health literacy-verified booklet and home safety items to promote competence to make home safety modifications."
1141218|NCT00459342|B1|Baseline|Dasatinib|Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1141219|NCT00459342|P1|Participant Flow|Dasatinib|Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1141220|NCT00459342|O1|Outcome|Dasatinib|Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1141221|NCT00459342|O1|Outcome|Dasatinib|Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1141276|NCT00459316|O3|Outcome|Group 2|Participants ≥11 to <25 years with CD4%<15
1141277|NCT00459316|O2|Outcome|Group 1 (CD4%≥25)|Participants ≥11 to <25 years with CD4%≥25
1141222|NCT00459342|E1|Reported Event|Dasatinib|Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
1141223|NCT00459316|B5|Baseline|Total|Total of all reporting groups
1141224|NCT00459316|B4|Baseline|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
1141225|NCT00459316|B3|Baseline|Group 2|Participants ≥11 to <25 years with CD4%<15
1141226|NCT00459316|B2|Baseline|Group 1 (CD4%≥25)|Participants ≥11 to <25 years with CD4%≥25
1141227|NCT00459316|B1|Baseline|Group 1 (15<CD4%<25)|Participants ≥11 to <25 years with 15<CD4%<25
1141228|NCT00459316|P3|Participant Flow|Group 3: Age ≥2 to <11, CD4%≥25|"Participants ≥2 to <11 years of age with CD4% at screening ≥ 25%; All receiving Quadrivalent meningococcal conjugate vaccine at entry, those who were eligible receiving Quadrivalent meningococcal conjugate vaccine at week 24, and 3 years.~Quadrivalent meningococcal conjugate vaccine: MCV4 vaccine (4 µg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 µg of diphtheria toxoid protein carrier ) was given by injection intramuscularly at least once and no more than two times for each participant, depending on adverse reactions."
1141229|NCT00459316|P2|Participant Flow|Group 2: CD4%<15, Age ≤11 to <25|"Participants ≤11 to <25 years of age with CD4% at screening <15%; All receiving Quadrivalent meningococcal conjugate vaccine at entry, those who were eligible receiving Quadrivalent meningococcal conjugate vaccine at week 24.~Quadrivalent meningococcal conjugate vaccine: MCV4 vaccine (4 µg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 µg of diphtheria toxoid protein carrier ) was given by injection intramuscularly at least once and no more than two times for each participant, depending on adverse reactions."
1141230|NCT00459316|P1|Participant Flow|Group 1: CD4%≥15, Age ≤11 to <25|"Participants ≤11 to <25 years of age with CD4% at screening ≥15%; All receiving Quadrivalent meningococcal conjugate vaccine at entry, those who were eligible/randomized receiving Quadrivalent meningococcal conjugate vaccine at week 24, and 3 years.~Quadrivalent meningococcal conjugate vaccine: MCV4 vaccine (4 µg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 µg of diphtheria toxoid protein carrier ) was given by injection intramuscularly at least once and no more than two times for each participant, depending on adverse reactions."
1141231|NCT00459316|O3|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25, 2 doses MCV4 vaccine
1141232|NCT00459316|O2|Outcome|Group 1B|Participants ≥11 to <25 years with CD4%>15, 2 doses MCV4 vaccine
1141233|NCT00459316|O1|Outcome|Group 1A|Participants ≥11 to <25 years with CD4%>15, 1 dose MCV4 vaccine
1141234|NCT00459316|O2|Outcome|Group 3|Participants >=2 to <11 years of age with CD4% at screening ≥ 25%
1141235|NCT00459316|O1|Outcome|Group 1|Participants ≤11 to <25 years of age with CD4% at screening ≥15%
1141236|NCT00459316|O2|Outcome|Group 1B|Participants ≥11 to <25 years with CD4%>15, 2 doses MCV4 vaccine
1141237|NCT00459316|O1|Outcome|Group 1A|Participants ≥11 to <25 years with CD4%>15, 1 dose MCV4 vaccine
1141238|NCT00459316|O2|Outcome|Group 1B|Participants ≥11 to <25 years with CD4%>15, 2 doses MCV4 vaccine
1141239|NCT00459316|O1|Outcome|Group 1A|Participants ≥11 to <25 years with CD4%>15, 1 dose MCV4 vaccine
1141240|NCT00459316|O4|Outcome|Group 3: Age 6-<11|Participants 6 to <11 years with CD4%>=25
1141241|NCT00459316|O3|Outcome|Group 3: Age 2-<6|Participants 2 to <6 years with CD4%>=25
1141242|NCT00459316|O2|Outcome|Group 1B|Participants ≥11 to <25 years with CD4%>15, 2 doses MCV4 vaccine
1141243|NCT00459316|O1|Outcome|Group 1A|Participants ≥11 to <25 years with CD4%>15, 1 dose MCV4 vaccine
1141244|NCT00459316|O3|Outcome|Week 72|Group 2 participants at Week 72
1141248|NCT00459316|O2|Outcome|Group 1B|Participants aged 11 to 24 with a CD4 percentage of or greater than 15%, 2 doses MCV4 vaccine
1141249|NCT00459316|O1|Outcome|Group 1A|Participants ≥11 to <25 years with CD4%>15, 1 dose MCV4 vaccine
1141250|NCT00459316|O3|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
1141251|NCT00459316|O2|Outcome|Group 1B|Participants ≥11 to <25 years with CD4%>15, 2 doses MCV4 vaccine
1141252|NCT00459316|O1|Outcome|Group 1A|Participants ≥11 to <25 years with CD4%>15, 1 dose MCV4 vaccine
1141253|NCT00459316|O3|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
1141254|NCT00459316|O2|Outcome|Group 1B|Participants ≥11 to <25 years with CD4%>15, 2 doses MCV4 vaccine
1141255|NCT00459316|O1|Outcome|Group 1A|Participants ≥11 to <25 years with CD4%>15, 1 dose MCV4 vaccine
1141256|NCT00459316|O3|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
1141257|NCT00459316|O2|Outcome|Group 1B|Participants ≥11 to <25 years with CD4%>15, 2 doses MCV4 vaccine
1141258|NCT00459316|O1|Outcome|Group 1A|Participants ≥11 to <25 years with CD4%>15, 1 dose MCV4 vaccine
1141259|NCT00459316|O4|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
1141260|NCT00459316|O3|Outcome|Group 2|Participants ≥11 to <25 years with CD4%<15
1141261|NCT00459316|O2|Outcome|Group 1 (CD4%≥25)|Participants ≥11 to <25 years with CD4%≥25
1141262|NCT00459316|O1|Outcome|Group 1 (15<CD4%<25)|Participants ≥11 to <25 years with 15<CD4%≤25
1141263|NCT00459316|O4|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4%≥25
1141264|NCT00459316|O3|Outcome|Group 2|Participants ≥11 to <25 years with CD4%<15
1141265|NCT00459316|O2|Outcome|Group 1 (CD4%≥25)|Participants ≥11 to <25 years with CD4%≥25
1141266|NCT00459316|O1|Outcome|Group 1 (15<CD4%<25)|Participants ≥11 to <25 years with 15<CD4%≤25
1141267|NCT00459316|O4|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4%≥25
1141268|NCT00459316|O3|Outcome|Group 2|Participants ≥11 to <25 years with CD4%<15
1141269|NCT00459316|O2|Outcome|Group 1 (CD4%≥25)|Participants ≥11 to <25 years with CD4%≥25
1141270|NCT00459316|O1|Outcome|Group 1 (15<CD4%<25)|Participants ≥11 to <25 years with 15<CD4%≤25
1141271|NCT00459316|O4|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4%≥25
1141272|NCT00459316|O3|Outcome|Group 2|Participants ≥11 to <25 years with CD4%<15
1141278|NCT00459316|O1|Outcome|Group 1 (15<CD4%<25)|Participants ≥11 to <25 years with 15<CD4%≤25
1141279|NCT00459316|E4|Reported Event|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
1141280|NCT00459316|E3|Reported Event|Group 2|Participants ≥11 to <25 years with CD4%<15
1141281|NCT00459316|E2|Reported Event|Group 1 (CD4%≥25)|Participants ≥11 to <25 years with CD4%≥25
1141282|NCT00459316|E1|Reported Event|Group 1 (15<CD4%≤25)|Participants ≥11 to <25 years with 15<CD4%≤25
1141283|NCT00459303|B1|Baseline|Cataract Patients|Patients with clinically significant cataract received cataract surgery and implantation of aspherical IOL in one eye and spherical IOL in the contralateral eye
1141284|NCT00459303|P1|Participant Flow|Cataract Patients|Patients with clinically significant cataract received cataract surgery and implantation of aspherical IOL in one eye and spherical IOL in the contralateral eye.
1141285|NCT00459303|O2|Outcome|Aspheric Intraocular Lens|patients recieved cataract surgery and recived spherical intraocuar lens(Tecnis Z9000,AMO) in the other eye.
1141286|NCT00459303|O1|Outcome|Spherical Intraocular Lens|patients recieved cataract surgery and recived spherical intraocuar lens(SA60AT, Alcon) in one eye.
1141287|NCT00459303|O2|Outcome|Aspherical Intraocular Lens|patients recieved cataract surgery and recived spherical intraocuar lens(Tecnis Z9000, AMO) in the other eye.
1141288|NCT00459303|O1|Outcome|Spherical Intraocular Lens|patients recieved cataract surgery and recived spherical intraocuar lens(SA60AT, Alcon) in one eye.
1141289|NCT00459303|O2|Outcome|Aspherical Intraocular Lens|patients recieved cataract surgery and recived spherical intraocuar lens(Tecnis Z9000,AMO) in the other eye.
1141290|NCT00459303|O1|Outcome|Spherical Intraocular Lens|patients recieved cataract surgery and recived spherical intraocuar lens(SA60AT, Alcon) in one eye.
1141291|NCT00459303|O2|Outcome|Aspherical Intraocular Lens|patients recieved cataract surgery and recived aspherical intraocuar lens(Tecnis Z9000, AMO) in the other eye.
1141292|NCT00459303|O1|Outcome|Spherical Intraocular Lens|patients recieved cataract surgery and recived spherical intraocuar lens(SA60AT, Alcon) in one eye.
1141293|NCT00459303|E1|Reported Event|Cataract Patients|Patients with clinically significant cataract received cataract surgery and implantation of aspherical IOL in one eye and spherical IOL in the contralateral eye
1141294|NCT00459290|B1|Baseline|Mifepristone|Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
1141295|NCT00459290|P1|Participant Flow|Mifepristone|Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
1141296|NCT00459290|O3|Outcome|>=70|
1141297|NCT00459290|O2|Outcome|60 <70|
1141298|NCT00459290|O1|Outcome|< 60|
1141299|NCT00459290|O2|Outcome|GOG Performance Status 1|Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work.
1141300|NCT00459290|O1|Outcome|GOG Performance Status 0|Fully active, able to carry on all pre-disease performance without restriction.
1141301|NCT00459290|O2|Outcome|Platinum Sensitive|
1141302|NCT00459290|O1|Outcome|Not Platinum Sensitive|
1141303|NCT00459290|O1|Outcome|Mifepristone|Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
1141304|NCT00459290|O1|Outcome|Mifepristone|Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
1141305|NCT00459290|O1|Outcome|Mifepristone|Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
1149013|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
1141306|NCT00459290|O1|Outcome|Mifepristone|Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
1141307|NCT00459290|E1|Reported Event|Mifepristone|Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
1141308|NCT00459186|B1|Baseline|RAD001 Followed by RAD001 + Docetaxel|RAD001 10 mg daily for 2 weeks, followed by RAD001 + Docetaxel at one of three doses: 5 mg RAD001 and docetaxel at 60 mg/m2, 10 mg RAD001 and docetaxel at 60 mg/m2, and 10 mg RAD001 and docetaxel at 70 mg/m2. RAD001 was given daily. Docetaxel was given every 3 weeks by intravenous infusion. Patients also received prednisone 5 mg by mouth twice daily.
1141309|NCT00459186|P1|Participant Flow|RAD001 Followed by RAD001 + Docetaxel|RAD001 10 mg daily for 2 weeks, followed by RAD001 + Docetaxel at one of three doses: 5 mg RAD001 and docetaxel at 60 mg/m2, 10 mg RAD001 and docetaxel at 60 mg/m2, and 10 mg RAD001 and docetaxel at 70 mg/m2. RAD001 was given daily. Docetaxel was given every 3 weeks by intravenous infusion. Patients also received prednisone 5 mg by mouth twice daily.
1141310|NCT00459186|O1|Outcome|RAD001 Followed by RAD001 + Docetaxel|RAD001 10 mg daily for 2 weeks, followed by RAD001 + Docetaxel at one of three doses: 5 mg RAD001 and docetaxel at 60 mg/m2, 10 mg RAD001 and docetaxel at 60 mg/m2, and 10 mg RAD001 and docetaxel at 70 mg/m2. RAD001 was given daily. Docetaxel was given every 3 weeks by intravenous infusion. Patients also received prednisone 5 mg by mouth twice daily.
1141311|NCT00459186|O1|Outcome|RAD001 Followed by RAD001 + Docetaxel|RAD001 10 mg daily for 2 weeks, followed by RAD001 + Docetaxel at one of three doses: 5 mg RAD001 and docetaxel at 60 mg/m2, 10 mg RAD001 and docetaxel at 60 mg/m2, and 10 mg RAD001 and docetaxel at 70 mg/m2. RAD001 was given daily. Docetaxel was given every 3 weeks by intravenous infusion. Patients also received prednisone 5 mg by mouth twice daily.
1141312|NCT00459186|E1|Reported Event|RAD001 Followed by RAD001 + Docetaxel|RAD001 10 mg daily for 2 weeks, followed by RAD001 + Docetaxel at one of three doses: 5 mg RAD001 and docetaxel at 60 mg/m2, 10 mg RAD001 and docetaxel at 60 mg/m2, and 10 mg RAD001 and docetaxel at 70 mg/m2. RAD001 was given daily. Docetaxel was given every 3 weeks by intravenous infusion. Patients also received prednisone 5 mg by mouth twice daily.
1141313|NCT00459134|B3|Baseline|Total|Total of all reporting groups
1141314|NCT00459134|B2|Baseline|Arm II: Placebo|"Patients receive oral placebo 3 pills twice daily~Placebo: Given orally"
1141315|NCT00459134|B1|Baseline|Arm I: ArginMax|"ArginMax® 3 pills twice daily~ArginMax: Given orally"
1141316|NCT00459134|P2|Participant Flow|Arm II: Placebo|"Patients receive oral placebo 3 pills twice daily~Placebo: Given orally"
1141317|NCT00459134|P1|Participant Flow|Arm I: ArginMax|"ArginMax® 3 pills twice daily~ArginMax: Given orally"
1141318|NCT00459134|O2|Outcome|Arm II: Placebo|"Patients receive oral placebo 3 pills twice daily~Placebo: Given orally"
1141319|NCT00459134|O1|Outcome|Arm I: ArginMax|"ArginMax® 3 pills twice daily~ArginMax: Given orally"
1141320|NCT00459134|O2|Outcome|Arm II: Placebo|"Patients receive oral placebo 3 pills twice daily~Placebo: Given orally"
1141321|NCT00459134|O1|Outcome|Arm I: ArginMax|"ArginMax® 3 pills twice daily~ArginMax: Given orally"
1141322|NCT00459134|E2|Reported Event|Arm II: Placebo|"Patients receive oral placebo 3 pills twice daily~Placebo: Given orally"
1141323|NCT00459134|E1|Reported Event|Arm I: ArginMax|"ArginMax® 3 pills twice daily~ArginMax: Given orally"
1141324|NCT00459121|B1|Baseline|Zactima, Paclitaxel, Carboplatin|"Zactima- 100 mg orally daily, starting on day 1 of cycle 1. Paclitaxel- 200mg/m2 IV, every 3 weeks starting on day 1 of cycle 1. Carboplatin AUC6 IV, every 3 weeks starting on day 1 of cycle 1 Duration of each cycle: 21 days. The last dose of zactima will be on the first day of the last cycle.~Neoadjuvant Surgery: Surgical resection of the tumor will be performed after the resolution of all the adverse effects from the last cycle of treatment but no earlier than 3 weeks after the last cycle of treatment."
1141325|NCT00459121|P1|Participant Flow|Zactima, Paclitaxel, Carboplatin|"Zactima- 100 mg orally daily, starting on day 1 of cycle 1. Paclitaxel- 200mg/m2 IV, every 3 weeks starting on day 1 of cycle 1. Carboplatin AUC6 IV, every 3 weeks starting on day 1 of cycle 1 Duration of each cycle: 21 days. The last dose of zactima will be on the first day of the last cycle.~Neoadjuvant Surgery: Surgical resection of the tumor will be performed after the resolution of all the adverse effects from the last cycle of treatment but no earlier than 3 weeks after the last cycle of treatment."
1141326|NCT00459121|O1|Outcome|Zactima+Carboplatin & Paclitaxel-assess Feasibility & Safety|Study closed before an evaluable number of participants could be accrued. No summary of statistics will be collected for two participants, per the statistician.
1141327|NCT00459121|E1|Reported Event|Zactima+Carboplatin & Paclitaxel-assess Feasibility & Safety|Study closed before an evaluable number of participants could be accrued. No summary of statistics will be collected for two participants, per the statistician.
1141328|NCT00459108|B1|Baseline|Oral Dasatinib|"Patients receive oral dasatinib twice daily at 70 mg on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~dasatinib: Given orally"
1141329|NCT00459108|P1|Participant Flow|Oral Dasatinib|"Patients receive oral dasatinib twice daily at 70 mg on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~dasatinib: Given orally"
1141330|NCT00459108|O1|Outcome|Oral Dasatinib|"Patients receive oral dasatinib twice daily at 70 mg on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~dasatinib: Given orally"
1141331|NCT00459108|O1|Outcome|Oral Dasatinib|"Patients receive oral dasatinib at 70 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~dasatinib: Given orally"
1141332|NCT00459108|E1|Reported Event|Oral Dasatinib|"Patients receive oral dasatinib at 70 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~dasatinib: Given orally"
1141333|NCT00459056|B3|Baseline|Total|Total of all reporting groups
1141334|NCT00459056|B2|Baseline|Lisinopril + HCTZ, Then Carvedilol CR + Lisinopril|Participants were randomized to Lisinopril + HCTZ for the first three months, then had a washout period for one month, and then were given Carvedilol CR + Lisinopril for the final three months.
1141335|NCT00459056|B1|Baseline|Carvedilol CR + Lisinopril, Then Lisinopril + HCTZ|Participants were randomized to Carvedilol CR + Lisinopril for the first three months, then had a washout period for one month, and then were given Lisinopril + HCTZ for the final three months.
1141336|NCT00459056|P2|Participant Flow|Lisinopril + HCTZ, Then Carvedilol CR + Lisinopril|Participants were randomized to Lisinopril + HCT for three months, then had a one month wash-out period, and then were randomized to Carvedilol CR + Lisinopril for the remaining three months. Lisinopril was initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day after one week. HCT was initiated at a dose of 12.5mg, once per day, then titrated to 25mg, once per day, after one week. For the second phase, Lisinophil was again initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day after one week. Carvedilol CR was initiated at a dose of 20mg, once per day, then titrated to 40mg, once per day after one week.
1141337|NCT00459056|P1|Participant Flow|Carvedilol CR + Lisinopril, Then Lisinopril + HCTZ|Participants were randomized to Carvedilol CR + Lisinopril for three months, then had a one month wash-out period, and then were randomized to Lisinopril + HCT for the remaining three months. Carvedilol CR was initiated at a dose of 20mg, once per day, then titrated to 40mg, once per day after one week. Lisinopril was initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day after one week. For the second phase, lisinopril was again initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day, after one week. HCT was initiated at a dose of 12.5mg, once per day, then titrated to 25mg, once per day, after one week.
1141338|NCT00459056|O2|Outcome|Lisinopril + HCTZ, Then Carvedilol CR + Lisinopril|Participants were randomized to Lisionopril +HCTZ for the first three months, then had a one month washout period, then were given Carvedilol CR + Lisinopril for the final three months. Lisinopril was initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day after one week. HCT was initiated at a dose of 12.5mg, once per day, then titrated to 25mg, once per day, after one week. For the second phase, lisinopril was again initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day, after one week. Carvedilol CR was initiated at a dose of 20mg, once per day, then titrated to 40mg, once per day after one week.
1141339|NCT00459056|O1|Outcome|Carvedilol CR + Lisinopril, Then Lisinopril +HCTZ|Participants were randomized to Carvedilol CR + Lisinopril for the first three months, then had a one month washout period, then were given Lisinopril + HCTZ for the final three months. Carvedilol CR was initiated at a dose of 20mg, once per day, then titrated to 40mg, once per day after one week. Lisinopril was initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day after one week. For the second phase, lisinopril was again initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day, after one week. HCT was initiated at a dose of 12.5mg, once per day, then titrated to 25mg, once per day, after one week.
1141340|NCT00459056|E2|Reported Event|Lisinopril + HCTZ, Then Carvedilol CR + Lisinopril|Participants were randomized to Lisinopril + HCTZ for the first three months, then had a washout period for one month, and then were given Carvedilol CR + Lisinopril for the final three months.
1141341|NCT00459056|E1|Reported Event|Carvedilol CR + Lisinopril, Then Lisinopril + HCTZ|Participants were randomized to Carvedilol CR + Lisinopril for the first three months, then had a washout period for one month, and then were given Lisinopril + HCTZ for the final three months.
1141342|NCT00459043|B3|Baseline|Total|Total of all reporting groups
1141343|NCT00459043|B2|Baseline|Combination of Docetaxel and Zactima|
1141344|NCT00459043|B1|Baseline|Docetaxel Single Agent|
1141345|NCT00459043|P2|Participant Flow|2 Combination Docetaxel and ZD6474|"Docetaxel with ZD6474~Docetaxel 75 mg/m2 was administered every 21 days intravenously. ZD6474 (Vandetanib) at 100 mg was administered as a once daily tablet given orally."
1141346|NCT00459043|P1|Participant Flow|1Docetaxel Single Agent|Docetaxel 75 mg/m2 was administered every 21 days intravenously.
1141347|NCT00459043|O2|Outcome|2 Combination Docetaxel and ZD6474|Docetaxel with ZD6474
1141348|NCT00459043|O1|Outcome|1Docetaxel Single Agent|Docetaxel Alone
1141349|NCT00459043|O2|Outcome|2 Combination Docetaxel and ZD6474|Docetaxel with ZD6474
1141350|NCT00459043|O1|Outcome|1Docetaxel Single Agent|Docetaxel Alone
1141351|NCT00459043|O2|Outcome|2 Combination Docetaxel and ZD6474|Docetaxel with ZD6474
1141352|NCT00459043|O1|Outcome|1Docetaxel Single Agent|Docetaxel Alone
1141353|NCT00459043|E2|Reported Event|2 Combination Docetaxel and ZD6474|Docetaxel with ZD6474
1141354|NCT00459043|E1|Reported Event|1Docetaxel Single Agent|Docetaxel Alone
1141355|NCT00458952|B3|Baseline|Total|Total of all reporting groups
1141356|NCT00458952|B2|Baseline|>500 mCi|14 subjects received a mean dose of greater than 500 mCi of Ultratrace Iobenguane I 131
1141357|NCT00458952|B1|Baseline|=< 500 mCi Ultratrace Iobenguane I 131|7 subjects received a mean dose less than or equal to 500 mCi of Ultratrace Iobenguane I 131
1141358|NCT00458952|P2|Participant Flow|>500 mCi|14 subjects received a mean dose of greater than 500 mCi of Ultratrace Iobenguane I 131
1141359|NCT00458952|P1|Participant Flow|=< 500 mCi Ultratrace Iobenguane I 131|7 subjects received a mean dose less than or equal to 500 mCi of Ultratrace Iobenguane I 131
1141360|NCT00458952|O1|Outcome|Ultratrace Iobenguane I 131|Each patient was to first receive an imaging dose of 5 mCi of Ultratrace iobenguane I 131 to confirm tumor uptake of the test article. If at least one tumor on a baseline CT/MRI scan was also visualized on the Ultratrace iobenguane I 131 scan, the patient was administered a therapeutic dose of Ultratrace iobenguane I 131. Dosing began at 6 mCi/kg for an initial cohort of 3 patients, and escalated in 1.0 mCi/kg increments until the MTD was established.
1141361|NCT00458952|E1|Reported Event|Ultratrace Iobenguane I 131|Each patient was to first receive an imaging dose of 5 mCi of Ultratrace iobenguane I 131 to confirm tumor uptake of the test article. If at least one tumor on a baseline CT/MRI scan was also visualized on the Ultratrace iobenguane I 131 scan, the patient was administered a therapeutic dose of Ultratrace iobenguane I 131. Dosing began at 6 mCi/kg for an initial cohort of 3 patients, and escalated in 1.0 mCi/kg increments until the MTD was established.
1141362|NCT00458822|B1|Baseline|All Patients|All patients treated with Melphalan with Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients with Systemic Light-Chain (AL) Amyloidosis
1141363|NCT00458822|P1|Participant Flow|All Patients|All patients treated with Melphalan with Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients with Systemic Light-Chain (AL) Amyloidosis
1141364|NCT00458822|O1|Outcome|All Patients|All patients treated with Melphalan with Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients with Systemic Light-Chain (AL) Amyloidosis
1144215|NCT00450073|P3|Participant Flow|Sunlamp|Use of a sunlamp 5 times a week for 12 weeks.
1141365|NCT00458822|E1|Reported Event|All Patients|All patients treated with Melphalan with Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients with Systemic Light-Chain (AL) Amyloidosis
1141366|NCT00458705|B1|Baseline|Combination Therapy|Combination therapy with bortezomib, pegylated liposomal doxorubicin and dexamethasone (BDD) followed by either thalidomide and dexamethasone (TD) or bortezomib, thalidomide and dexamethasone in patients with symptomatic untreated high-risk or primary resistant multiple myeloma. Three cycles of BDD will be administered. Patients who respond after three cycles will receive two cycles of TD. Patients with stable or progressive disease after three cycles of BDD receive two cycles of bortezomib, thalidomide and dexamethasone. If at any point during the study a patient achieves a complete response (CR), the patient will be given the option to discontinue treatment on-study.
1141367|NCT00458705|P1|Participant Flow|Combination Therapy|Combination therapy with bortezomib, pegylated liposomal doxorubicin and dexamethasone (BDD) followed by either thalidomide and dexamethasone (TD) or bortezomib, thalidomide and dexamethasone in patients with symptomatic untreated high-risk or primary resistant multiple myeloma. Three cycles of BDD will be administered. Patients who respond after three cycles will receive two cycles of TD. Patients with stable or progressive disease after three cycles of BDD receive two cycles of bortezomib, thalidomide and dexamethasone. If at any point during the study a patient achieves a complete response (CR), the patient will be given the option to discontinue treatment on-study.
1141368|NCT00458705|O1|Outcome|Combination Therapy|Combination therapy with bortezomib, pegylated liposomal doxorubicin and dexamethasone (BDD) followed by either thalidomide and dexamethasone (TD) or bortezomib, thalidomide and dexamethasone in patients with symptomatic untreated high-risk or primary resistant multiple myeloma. Three cycles of BDD will be administered. Patients who respond after three cycles will receive two cycles of TD. Patients with stable or progressive disease after three cycles of BDD receive two cycles of bortezomib, thalidomide and dexamethasone. If at any point during the study a patient achieves a complete response (CR), the patient will be given the option to discontinue treatment on-study.
1141416|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
1141417|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
1141418|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
1141419|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
1141420|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
1141369|NCT00458705|E1|Reported Event|Combination Therapy|Combination therapy with bortezomib, pegylated liposomal doxorubicin and dexamethasone (BDD) followed by either thalidomide and dexamethasone (TD) or bortezomib, thalidomide and dexamethasone in patients with symptomatic untreated high-risk or primary resistant multiple myeloma. Three cycles of BDD will be administered. Patients who respond after three cycles will receive two cycles of TD. Patients with stable or progressive disease after three cycles of BDD receive two cycles of bortezomib, thalidomide and dexamethasone. If at any point during the study a patient achieves a complete response (CR), the patient will be given the option to discontinue treatment on-study.
1141370|NCT00458536|B1|Baseline|Patients Treated With Vaccine|Patients with renal cell carcinoma following debulking nephrectomy who receive at least 2 doses of DC/renal fusion vaccine.
1141371|NCT00458536|P1|Participant Flow|Patients Treated With Vaccine|Patients with renal cell carcinoma following debulking nephrectomy who receive at least 2 doses of DC/renal fusion vaccine.
1141372|NCT00458536|O1|Outcome|Patients Treated With Vaccine|Patients with renal cell carcinoma following debulking nephrectomy who receive at least 2 doses of DC/renal fusion vaccine.
1141373|NCT00458536|E1|Reported Event|Patients Treated With Vaccine|Patients with renal cell carcinoma following debulking nephrectomy who receive at least 2 doses of DC/renal fusion vaccine.
1141374|NCT00458406|B3|Baseline|Total|Total of all reporting groups
1141375|NCT00458406|B2|Baseline|CPAP|Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
1141376|NCT00458406|B1|Baseline|Bi-Flex|Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study.
1141377|NCT00458406|P2|Participant Flow|CPAP|"Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.~Subjects in this arm underwent standard continuous positive airway pressure (CPAP) therapy.~In this randomized, double-blinded clinical trial, patients with obstructive sleep apnea were randomized Bi-Flex or CPAP, and a repeat polysomnography was performed on pressure at 3 months.~Of the N=56 assessed subjects, N=13 were enrolled into the CPAP arm."
1141378|NCT00458406|P1|Participant Flow|Bi-Flex|"Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study. Subjects in this arm underwent bilevel positive airway pressure with pressure release technology (Bi-Flex) therapy. In this randomized, double-blinded clinical trial, patients with obstructive sleep apnea were randomized Bi-Flex or CPAP, and a repeat polysomnography was performed on pressure at 3 months.~Of the N=56 assessed subjects, N=43 were enrolled into the Bi-Flex arm."
1141379|NCT00458406|O2|Outcome|CPAP|Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
1141380|NCT00458406|O1|Outcome|Bi-Flex|Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study.
1141381|NCT00458406|O2|Outcome|CPAP|Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
1141382|NCT00458406|O1|Outcome|Bi-Flex|Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study.
1141383|NCT00458406|O2|Outcome|CPAP|Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
1141384|NCT00458406|O1|Outcome|Bi-Flex|Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study.
1141385|NCT00458406|O2|Outcome|CPAP|Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
1141386|NCT00458406|O1|Outcome|Bi-Flex|Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study.
1141387|NCT00458406|O2|Outcome|CPAP|Subjects in this arm underwent standard continuous positive airway pressure (CPAP) therapy.
1141388|NCT00458406|O1|Outcome|BiFlex|Subjects in this arm underwent bilevel positive airway pressure with pressure release technology (Bi-Flex) therapy.
1141389|NCT00458406|O2|Outcome|CPAP|Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
1141390|NCT00458406|O1|Outcome|Bi-Flex|Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study.
1144216|NCT00450073|P2|Participant Flow|Vitamin D2|vitamin D2 50,000 IU weekly
1141391|NCT00458406|O2|Outcome|CPAP|Subjects in this arm underwent standard continuous positive airway pressure (CPAP) therapy.
1141392|NCT00458406|O1|Outcome|Bi-Flex|Subjects in this arm underwent bilevel positive airway pressure with pressure release technology (Bi-Flex) therapy.
1141393|NCT00458406|E2|Reported Event|CPAP|Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
1141394|NCT00458406|E1|Reported Event|Bi-Flex|Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study.
1141395|NCT00458302|B3|Baseline|Total|Total of all reporting groups
1141396|NCT00458302|B2|Baseline|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
1141397|NCT00458302|B1|Baseline|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
1141398|NCT00458302|P2|Participant Flow|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
1141399|NCT00458302|P1|Participant Flow|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
1141400|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
1141401|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
1141402|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
1141403|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
1141404|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
1141405|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
1141406|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
1141407|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
1141408|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
1141409|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
1141410|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
1141411|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
1141412|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
1141413|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
1141414|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
1141415|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
1141421|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
1141422|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
1141423|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
1141424|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
1141425|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
1141426|NCT00458302|E3|Reported Event|Total|
1141427|NCT00458302|E2|Reported Event|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
1141428|NCT00458302|E1|Reported Event|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
1141429|NCT00458237|B4|Baseline|Total|Total of all reporting groups
1141430|NCT00458237|B3|Baseline|Phase II: Everolimus (Maximum Tolerated Dose) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus at the MTD (10 mg) by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
1141431|NCT00458237|B2|Baseline|Phase I: Everolimus (Dose Level 2) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 10 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
1141432|NCT00458237|B1|Baseline|Phase I: Everolimus (Dose Level 1) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 5 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
1141433|NCT00458237|P3|Participant Flow|Phase II: Everolimus (Maximum Tolerated Dose) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus at the MTD (10 mg) by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
1141434|NCT00458237|P2|Participant Flow|Phase I: Everolimus (Dose Level 2) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 10 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
1141435|NCT00458237|P1|Participant Flow|Phase I: Everolimus (Dose Level 1) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 5 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
1141436|NCT00458237|O2|Outcome|Phase II: Everolimus (Maximum Tolerated Dose) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus at the MTD (10 mg) by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
1141437|NCT00458237|O1|Outcome|Phase I: Everolimus (Dose Level 2) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 10 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
1141438|NCT00458237|O2|Outcome|Phase I: Everolimus (Dose Level 2) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 10 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
1141439|NCT00458237|O1|Outcome|Phase I: Everolimus (Dose Level 1) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 5 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
1144217|NCT00450073|P1|Participant Flow|Vitamin D3|vitamin D3 50,000 IU weekly
1141440|NCT00458237|E3|Reported Event|Phase II: Everolimus (Maximum Tolerated Dose) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus at the MTD (10 mg) by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
1141441|NCT00458237|E2|Reported Event|Phase I: Everolimus (Dose Level 2) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 10 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
1141442|NCT00458237|E1|Reported Event|Phase I: Everolimus (Dose Level 1) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 5 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
1141443|NCT00458211|B1|Baseline|Experimental|Open label change to ziprasidone
1141444|NCT00458211|P1|Participant Flow|Experimental|Open label change to ziprasidone up to 120mg twice a day with meals
1141445|NCT00458211|O1|Outcome|Experimental|Open label change to ziprasidone
1141446|NCT00458211|O1|Outcome|Experimental|Open label change to ziprasidone
1141447|NCT00458211|O1|Outcome|Experimental|All subjects, 17 at Buffalo and 19 at Bronx were given Ziprasidone.
1141448|NCT00458211|O1|Outcome|Experimental|
1141449|NCT00458211|O1|Outcome|Experimental|Open label change to ziprasidone
1141450|NCT00458211|O1|Outcome|Experimental|Open label change to ziprasidone
1141451|NCT00458211|O1|Outcome|Experimental|Open label change to ziprasidone
1141452|NCT00458211|O1|Outcome|Experimental|Open label change to ziprasidone
1141453|NCT00458211|E1|Reported Event|Experimental|Open label change to ziprasidone
1141454|NCT00457977|B3|Baseline|Total|Total of all reporting groups
1141455|NCT00457977|B2|Baseline|Prevnar (PCV7)|diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
1141456|NCT00457977|B1|Baseline|Pneumovax (PPSV23)|pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)
1141457|NCT00457977|P2|Participant Flow|Prevnar (PCV7)|diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
1141458|NCT00457977|P1|Participant Flow|Pneumovax (PPSV23)|pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)
1141459|NCT00457977|O2|Outcome|Prevnar (PCV7)|diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
1141460|NCT00457977|O1|Outcome|Pneumovax (PPSV23)|pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)
1141461|NCT00457977|O2|Outcome|Prevnar (PCV7)|diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
1141462|NCT00457977|O1|Outcome|Pneumovax (PPSV23)|pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)
1141463|NCT00457977|E2|Reported Event|Prevnar (PCV7)|diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
1141464|NCT00457977|E1|Reported Event|Pneumovax (PPSV23)|pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)
1141465|NCT00457951|B4|Baseline|Total|Total of all reporting groups
1141466|NCT00457951|B3|Baseline|ODSH Treatment Group|ODSH Treatment Group Administered as bolus; then continuous administration over 96 hours in hospitalized subjects with exacerbations of COPD
1141467|NCT00457951|B2|Baseline|Placebo Comparator: Placebo-Control: 0.9% Sodium Chloride|Placebo Comparator: Placebo-Control: 0.9% Sodium Chloride Administered as bolus; then continuous administration over 96 hours in hospitalized subjects with exacerbations of COPD
1141468|NCT00457951|B1|Baseline|Open-Label|Open-Label ODSH
1141469|NCT00457951|P3|Participant Flow|ODSH Treatment Group|Double-blind randomized phase: The subjects receiving ODSH in the randomized portion of the study received 0.375 mg/kg/hr continuous IV infusion of ODSH for 96 hours.
1141470|NCT00457951|P2|Participant Flow|Placebo Comparator: 0.9% Sodium Chloride|Double-blind randomized phase: Normal Saline infusion: Bolus infusion followed by a 4 day continuous infusion of placebo.
1141471|NCT00457951|P1|Participant Flow|Open Label|"Open Label~The original protocol called for 304 subjects with exacerbation of COPD to be enrolled into the study. Thirteen patients with exacerbation of COPD were enrolled in the initial open label portion of the study. Of these thirteen subjects, the initial seven subjects were treated with an IV bolus of ODSH at 8 mg/kg followed by a continuous infusion of ODSH at 0.5 mg/kg/hr for 72 hours.~After an ad hoc safety committee assessed the safety of the data from the first seven subjects, six more subjects were treated concomitantly treated with ODSH and enoxaparin, a low molecular weight heparin commonly used for seriously ill hospitalized patients as DVT prophylaxis."
1141472|NCT00457951|O2|Outcome|Randomized, Blinded, ODSH Arm|"Subjects will receive standard of care treatment. ODSH is administered in bolus doses estimated to inhibit inflammatory mediators randomized 1:1 to ODSH 8mg/kg or placebo. The continuous infusion dose will be 0.375 mg/kg/hr over 96 hours.~ODSH: Randomized, Blinded, ODSH Arm"
1141473|NCT00457951|O1|Outcome|0.9% Sodium Chloride|"Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride Solution bolus; dose of 0.375mg/kg/hr over 96 hours.~Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride: Placebo-Control Arm: Bolus infusion followed by a 96 hour continuous infusion of 0.9%Sodium Chloride"
1141474|NCT00457951|E3|Reported Event|ODSH Treatment Group|"Subjects will receive standard of care treatment. ODSH is administered in bolus doses estimated to inhibit inflammatory mediators randomized 1:1 to ODSH 8mg/kg or placebo. The continuous infusion dose will be 0.375 mg/kg/hr over 96 hours.~ODSH: Randomized, Blinded, ODSH Arm"
1141475|NCT00457951|E2|Reported Event|Placebo Comparator: 0.9% Sodium Chloride|"Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride Solution bolus; dose of 0.375mg/kg/hr over 96 hours.~Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride: Placebo-Control Arm: Bolus infusion followed by a 96 hour continuous infusion of 0.9%Sodium Chloride"
1141476|NCT00457951|E1|Reported Event|Open Label|"Initial six subjects treated with ODSH open-label to confirm safety in subjects with an acute exacerbation of COPD; six additional patients will be enrolled following safety review.~Open-Label: ODSH administered open-label"
1141477|NCT00457821|B9|Baseline|Total|Total of all reporting groups
1141478|NCT00457821|B8|Baseline|Part 2: Placebo|Part 2: placebo q12h; 28 days
1141479|NCT00457821|B7|Baseline|Part 2: 250 mg|Part 2: Ivacaftor (250 mg) q12h; 28 days
1141480|NCT00457821|B6|Baseline|Part 2: 150 mg|Part 2: Ivacaftor (150 mg) q12h; 28 days
1141481|NCT00457821|B5|Baseline|Part 1: 150 mg/75 mg|Part 1: Ivacaftor (150 mg/75 mg) every 12 hours (q12h); 14 days/14 days.
1141482|NCT00457821|B4|Baseline|Part 1: 75 mg/150 mg|Part 1: Ivacaftor (75 mg/150 mg) every 12 hours (q12h); 14 days/14 days.
1141483|NCT00457821|B3|Baseline|Part 1: 75 mg/25 mg|Part 1: Ivacaftor (75 mg/25 mg) every 12 hours (q12h); 14 days/14 days.
1141484|NCT00457821|B2|Baseline|Part 1: 25 mg/75 mg|Part 1: Ivacaftor (25 mg/75 mg) every 12 hours (q12h); 14 days/14 days.
1141485|NCT00457821|B1|Baseline|Part 1: Placebo|Part 1: placebo every 12 hours (q12h); 14 days/14 days.
1141486|NCT00457821|P8|Participant Flow|Part 2: Placebo|Part 2: placebo q12h; 28 days
1141487|NCT00457821|P7|Participant Flow|Part 2: 250 mg|Part 2: Ivacaftor (250 mg) q12h; 28 days
1141488|NCT00457821|P6|Participant Flow|Part 2: 150 mg|Part 2: Ivacaftor (150 mg) q12h; 28 days
1141489|NCT00457821|P5|Participant Flow|Part 1: 150 mg/75 mg|Part 1: Ivacaftor (150 mg/75 mg) every 12 hours (q12h); 14 days/14 days.
1141490|NCT00457821|P4|Participant Flow|Part 1: 75 mg/150 mg|Part 1: Ivacaftor (75 mg/150 mg) every 12 hours (q12h); 14 days/14 days.
1141491|NCT00457821|P3|Participant Flow|Part 1: 75 mg/25 mg|Part 1: Ivacaftor (75 mg/25 mg) every 12 hours (q12h); 14 days/14 days.
1141492|NCT00457821|P2|Participant Flow|Part 1: 25 mg/75 mg|Part 1: Ivacaftor (25 mg/75 mg) every 12 hours (q12h); 14 days/14 days.
1141493|NCT00457821|P1|Participant Flow|Part 1: Placebo|Part 1: placebo every 12 hours (q12h); 14 days/14 days.
1141494|NCT00457821|O2|Outcome|Ivacaftor|All subjects given Ivacaftor in Part 1 (n=16) and Part 2 (n=15)
1141495|NCT00457821|O1|Outcome|Placebo|All subjects given placebo in Part 1 (n=4) and Part 2 (n=4)
1141496|NCT00457821|O5|Outcome|250 mg Ivacaftor q12h|All subjects given the 250 mg dose q12h in Group C (n=7) in Part 2.
1141497|NCT00457821|O4|Outcome|150 mg Ivacaftor q12h|All subjects given the 150 mg dose q12h in Group B in Part 1 (n=4 x 2) and Group C in Part 2 (n=8).
1141498|NCT00457821|O3|Outcome|75 mg Ivacaftor q12h|All subjects given the 75 mg dose q12h in Group A (n=4 x 2) and Group B (n=4 x 2) in Part 1.
1141499|NCT00457821|O2|Outcome|25 mg Ivacaftor q12h|All subjects given the 25 mg dose q12h in Group A in Part 1 (n=4 x 2).
1141500|NCT00457821|O1|Outcome|Placebo|All subjects given placebo every 12 hours (q12h) in Part 1 (n=4) and Part 2 (n=4)
1141501|NCT00457821|O3|Outcome|250 mg Ivacaftor q12h|Subjects given 250 mg of ivacaftor q12h for 28 days.
1141502|NCT00457821|O2|Outcome|150 mg Ivacaftor q12h|Subjects given 150 mg of ivacaftor q12h for 28 days.
1141503|NCT00457821|O1|Outcome|Placebo|Subjects given placebo every 12 hours (q12h) for 28 days.
1144178|NCT00450216|O2|Outcome|Ibuprofen|Ibuprofen 800mg
1141504|NCT00457821|O5|Outcome|250 mg Ivacaftor q12h|All subjects given the 250 mg dose q12h in Group C (n=7) in Part 2.
1141505|NCT00457821|O4|Outcome|150 mg Ivacaftor q12h|All subjects given the 150 mg dose q12h in Group B in Part 1 (n=4 x 2) and Group C in Part 2 (n=8).
1141506|NCT00457821|O3|Outcome|75 mg Ivacaftor q12h|All subjects given the 75 mg dose q12h in Group A (n=4 x 2) and Group B (n=4 x 2) in Part 1.
1141507|NCT00457821|O2|Outcome|25 mg Ivacaftor q12h|All subjects given the 25 mg dose q12h in Group A in Part 1 (n=4 x 2).
1141508|NCT00457821|O1|Outcome|Placebo|All subjects given placebo every 12 hours (q12h) in Part 1 (n=4) and Part 2 (n=4)
1141509|NCT00457821|O5|Outcome|250 mg Ivacaftor q12h|All subjects given the 250 mg dose q12h in Group C (n=7) in Part 2.
1141510|NCT00457821|O4|Outcome|150 mg Ivacaftor q12h|All subjects given the 150 mg dose q12h in Group B in Part 1 (n=4 x 2) and Group C in Part 2 (n=8).
1141511|NCT00457821|O3|Outcome|75 mg Ivacaftor q12h|All subjects given the 75 mg dose q12h in Group A (n=4 x 2) and Group B (n=4 x 2) in Part 1.
1141512|NCT00457821|O2|Outcome|25 mg Ivacaftor q12h|All subjects given the 25 mg dose q12h in Group A in Part 1 (n=4 x 2).
1141513|NCT00457821|O1|Outcome|Placebo|All subjects given placebo every 12 hours (q12h) in Part 1 (n=4) and Part 2 (n=4)
1141514|NCT00457821|O2|Outcome|Ivacaftor|All subjects given Ivacaftor in Part 1 (n=16) and Part 2 (n=15)
1141515|NCT00457821|O1|Outcome|Placebo|All subjects given placebo in Part 1 (n=4) and Part 2 (n=4)
1141516|NCT00457821|E5|Reported Event|250 mg Ivacaftor q12h|All subjects given the 250 mg dose q12h in Group C (n=7) in Part 2.
1141517|NCT00457821|E4|Reported Event|150 mg Ivacaftor q12h|All subjects given the 150 mg dose q12h in Group B in Part 1 (n=4 x 2) and Group C in Part 2 (n=8).
1141518|NCT00457821|E3|Reported Event|75 mg Ivacaftor q12h|All subjects given the 75 mg dose q12h in Group A (n=4 x 2) and Group B (n=4 x 2) in Part 1.
1141519|NCT00457821|E2|Reported Event|25 mg Ivacaftor q12h|All subjects given the 25 mg dose q12h in Group A in Part 1 (n=4 x 2).
1141520|NCT00457821|E1|Reported Event|Placebo|All subjects given placebo every 12 hours (q12h) in Part 1 (n=4) and Part 2 (n=4)
1141521|NCT00457795|B1|Baseline|Brimonidine 0.1%|Brimonidine 0.1%
1141522|NCT00457795|P1|Participant Flow|Brimonidine 0.1%|Brimonidine 0.1%
1141523|NCT00457795|O1|Outcome|Brimonidine 0.1%|Brimonidine 0.1%
1141524|NCT00457795|O1|Outcome|Brimonidine 0.1%|Brimonidine 0.1%
1141525|NCT00457795|O1|Outcome|Brimonidine 0.1%|Brimonidine 0.1%
1141526|NCT00457795|O1|Outcome|Brimonidine 0.1%|Brimonidine 0.1%
1141527|NCT00457795|E1|Reported Event|Brimonidine 0.1%|Brimonidine 0.1%
1141528|NCT00457743|B4|Baseline|Total|Total of all reporting groups
1141529|NCT00457743|B3|Baseline|SU-011248 75-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
1141585|NCT00457730|O1|Outcome|Duloxetine|"subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg.~Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions.~Placebo: Subjects are randomized to either Duloxetine or Placebo"
1141530|NCT00457743|B2|Baseline|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
1141531|NCT00457743|B1|Baseline|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
1141532|NCT00457743|P3|Participant Flow|SU-011248 75-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
1141533|NCT00457743|P2|Participant Flow|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
1141534|NCT00457743|P1|Participant Flow|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
1141535|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
1141536|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
1141537|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
1141538|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
1141539|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
1141586|NCT00457730|E2|Reported Event|Placebo|Placebo: Matching placebo drug for 7 weeks total
1141708|NCT00457015|O2|Outcome|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
1141540|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
1141541|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
1141542|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
1141543|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
1141544|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
1141622|NCT00457392|B2|Baseline|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
1141545|NCT00457743|O3|Outcome|SU-011248 75-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
1141546|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
1141547|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
1141548|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
1141549|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
1144218|NCT00450073|O3|Outcome|Sunlamp|Weekly use of a sunlamp
1141550|NCT00457743|O3|Outcome|SU-011248 75-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
1141551|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
1141552|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
1141553|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
1141554|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
1141623|NCT00457392|B1|Baseline|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
1145169|NCT00446641|B3|Baseline|Total|Total of all reporting groups
1141555|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
1141556|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
1141557|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
1141558|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
1141587|NCT00457730|E1|Reported Event|Duloxetine|Study drug, Duloxetine, 30 mg for 1 week, titrate up to 60 mg for 5 weeks and titrate back down to 30 mg for 1 week.
1141588|NCT00457691|B3|Baseline|Total|Total of all reporting groups
1141641|NCT00457301|B2|Baseline|HUI2 and HUI3 Completion and Feedback to Clinicians|Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
1144219|NCT00450073|O2|Outcome|Vitamin D2|vitamin D2 50,000 IU weekly
1141559|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
1141560|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
1141561|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
1141562|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
1141563|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
1141564|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
1141662|NCT00457249|O2|Outcome|DECAVAC® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
1141565|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
1141566|NCT00457743|O3|Outcome|SU-011248 75-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
1141567|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
1141568|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
1141569|NCT00457743|O3|Outcome|SU-011248 75-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
1141570|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
1141571|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
1141572|NCT00457743|E3|Reported Event|SU-011248 75-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
1141573|NCT00457743|E2|Reported Event|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
1141574|NCT00457743|E1|Reported Event|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
1141575|NCT00457730|B3|Baseline|Total|Total of all reporting groups
1141624|NCT00457392|P2|Participant Flow|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
1141576|NCT00457730|B2|Baseline|Placebo|"subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg.~Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions.~Placebo: Subjects are randomized to either Duloxetine or Placebo"
1141577|NCT00457730|B1|Baseline|Duloxetine|"subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg.~Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions.~Placebo: Subjects are randomized to either Duloxetine or Placebo"
1141578|NCT00457730|P2|Participant Flow|Placebo|subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg.
1141579|NCT00457730|P1|Participant Flow|Duloxetine|"subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg.~Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions.~Placebo: Subjects are randomized to either Duloxetine or Placebo"
1141580|NCT00457730|O2|Outcome|Placebo|matched placebo medication with same periods
1141581|NCT00457730|O1|Outcome|Duloxetine|Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week
1141582|NCT00457730|O2|Outcome|Placebo|matched placebo medication throughout 6 week observation period
1141583|NCT00457730|O1|Outcome|Duloxetine|ubjects will take 30 mg daily for 1 week, then 60 mg daily for 5 weeks, then titrate back down to 30 mg daily for 1 week.
1141584|NCT00457730|O2|Outcome|Placebo|"subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg.~Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions.~Placebo: Subjects are randomized to either Duloxetine or Placebo"
1141639|NCT00457392|E1|Reported Event|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
1141640|NCT00457301|B3|Baseline|Total|Total of all reporting groups
1141589|NCT00457691|B2|Baseline|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
1141590|NCT00457691|B1|Baseline|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
1141591|NCT00457691|P2|Participant Flow|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
1141592|NCT00457691|P1|Participant Flow|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
1141593|NCT00457691|O2|Outcome|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
1141594|NCT00457691|O1|Outcome|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
1141595|NCT00457691|O2|Outcome|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
1141596|NCT00457691|O1|Outcome|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
1141597|NCT00457691|O2|Outcome|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
1141598|NCT00457691|O1|Outcome|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
1141599|NCT00457691|O2|Outcome|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
1141600|NCT00457691|O1|Outcome|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
1141601|NCT00457691|O2|Outcome|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
1141602|NCT00457691|O1|Outcome|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
1141603|NCT00457691|O2|Outcome|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
1141604|NCT00457691|O1|Outcome|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
1141642|NCT00457301|B1|Baseline|HUI2 and HUI3 Completion Without Feedback to Clinicians.|Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
1141605|NCT00457691|O2|Outcome|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
1141606|NCT00457691|O1|Outcome|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
1141607|NCT00457691|O2|Outcome|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
1141608|NCT00457691|O1|Outcome|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
1141609|NCT00457691|E2|Reported Event|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
1141610|NCT00457691|E1|Reported Event|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
1141611|NCT00457418|B1|Baseline|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
1141612|NCT00457418|P1|Participant Flow|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
1141613|NCT00457418|O1|Outcome|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
1141614|NCT00457418|O1|Outcome|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
1141615|NCT00457418|O1|Outcome|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
1141616|NCT00457418|O1|Outcome|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
1141617|NCT00457418|O1|Outcome|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
1141618|NCT00457418|O1|Outcome|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
1141619|NCT00457418|O1|Outcome|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
1141620|NCT00457418|E1|Reported Event|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
1141621|NCT00457392|B3|Baseline|Total|Total of all reporting groups
1141625|NCT00457392|P1|Participant Flow|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
1141626|NCT00457392|O2|Outcome|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
1141627|NCT00457392|O1|Outcome|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
1141628|NCT00457392|O2|Outcome|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
1141629|NCT00457392|O1|Outcome|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
1141630|NCT00457392|O2|Outcome|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
1141631|NCT00457392|O1|Outcome|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
1141632|NCT00457392|O2|Outcome|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
1141633|NCT00457392|O1|Outcome|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
1141634|NCT00457392|O2|Outcome|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
1141635|NCT00457392|O1|Outcome|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
1141636|NCT00457392|O2|Outcome|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
1141637|NCT00457392|O1|Outcome|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
1141638|NCT00457392|E2|Reported Event|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
1141707|NCT00457015|O1|Outcome|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
1141643|NCT00457301|P2|Participant Flow|HUI2 and HUI3 Completion and Feedback to Clinicians|Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
1141644|NCT00457301|P1|Participant Flow|HUI2 and HUI3 Completion Without Feedback to Clinicians.|Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
1141645|NCT00457301|O2|Outcome|HUI2 and HUI3 Completion and Feedback to Clinicians|Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
1141646|NCT00457301|O1|Outcome|HUI2 and HUI3 Completion Without Feedback to Clinicians.|Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
1141647|NCT00457301|O2|Outcome|HUI2 and HUI3 Completion and Feedback to Clinicians|Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
1141648|NCT00457301|O1|Outcome|HUI2 and HUI3 Completion Without Feedback to Clinicians.|Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
1141649|NCT00457301|O2|Outcome|HUI2 and HUI3 Completion and Feedback to Clinicians|Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
1141650|NCT00457301|O1|Outcome|HUI2 and HUI3 Completion Without Feedback to Clinicians.|Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
1141651|NCT00457301|O2|Outcome|HUI2 and HUI3 Completion and Feedback to Clinicians|Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
1141652|NCT00457301|O1|Outcome|HUI2 and HUI3 Completion Without Feedback to Clinicians.|Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
1141653|NCT00457301|E2|Reported Event|HUI2 and HUI3 Completion and Feedback to Clinicians|Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
1141654|NCT00457301|E1|Reported Event|HUI2 and HUI3 Completion Without Feedback to Clinicians.|Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
1141655|NCT00457249|B3|Baseline|Total|Total of all reporting groups
1141656|NCT00457249|B2|Baseline|DECAVAC® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
1141657|NCT00457249|B1|Baseline|ADACEL® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
1141658|NCT00457249|P2|Participant Flow|DECAVAC® Vaccine Group|Participants received a single dose of DECAVAC® vaccine.
1141659|NCT00457249|P1|Participant Flow|ADACEL® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
1141660|NCT00457249|O2|Outcome|DECAVAC® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
1141661|NCT00457249|O1|Outcome|ADACEL® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
1141663|NCT00457249|O1|Outcome|ADACEL® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
1141664|NCT00457249|O2|Outcome|DECAVAC® Vaccine Group|Participants received a single dose of DECAVAC® vaccine.
1141665|NCT00457249|O1|Outcome|Adacel® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
1141666|NCT00457249|O2|Outcome|DECAVAC® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
1141667|NCT00457249|O1|Outcome|ADACEL® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
1141668|NCT00457249|E2|Reported Event|DECAVAC® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
1141669|NCT00457249|E1|Reported Event|ADACEL® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
1141670|NCT00457197|B3|Baseline|Total|Total of all reporting groups
1141671|NCT00457197|B2|Baseline|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
1141672|NCT00457197|B1|Baseline|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
1141673|NCT00457197|P2|Participant Flow|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
1141674|NCT00457197|P1|Participant Flow|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
1141675|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
1141676|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
1141677|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
1141678|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
1144220|NCT00450073|O1|Outcome|Vitamin D3|vitamin D3 50,000 IU weekly
1141679|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
1141680|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
1141681|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
1141682|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
1141683|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
1141684|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
1141685|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
1141686|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
1141687|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
1141688|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
1141726|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1145170|NCT00446641|B2|Baseline|Placebo|matching placebo to cilostazol
1141689|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
1141690|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
1141691|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
1141692|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
1141693|NCT00457197|E2|Reported Event|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
1141694|NCT00457197|E1|Reported Event|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
1141695|NCT00457015|B3|Baseline|Total|Total of all reporting groups
1141696|NCT00457015|B2|Baseline|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
1141697|NCT00457015|B1|Baseline|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
1141698|NCT00457015|P2|Participant Flow|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
1141699|NCT00457015|P1|Participant Flow|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
1141700|NCT00457015|O2|Outcome|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
1141701|NCT00457015|O1|Outcome|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
1141702|NCT00457015|O2|Outcome|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
1141703|NCT00457015|O1|Outcome|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
1141704|NCT00457015|O2|Outcome|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
1141705|NCT00457015|O1|Outcome|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
1141706|NCT00457015|O2|Outcome|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
1141709|NCT00457015|O1|Outcome|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
1141710|NCT00457015|E2|Reported Event|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
1141711|NCT00457015|E1|Reported Event|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
1141712|NCT00457002|B3|Baseline|Total|Total of all reporting groups
1141713|NCT00457002|B2|Baseline|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141714|NCT00457002|B1|Baseline|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1141715|NCT00457002|P2|Participant Flow|Enoxaparin 40 mg Subcutaneous|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141716|NCT00457002|P1|Participant Flow|Apixaban 2.5 mg Oral|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1141717|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141718|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1141719|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141720|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1141721|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141722|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1141723|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141724|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1141725|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1145171|NCT00446641|B1|Baseline|Cilostazol|Cilostazol 100mg twice per day
1141727|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141728|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1141729|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141730|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1141731|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141732|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1141733|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141734|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1141735|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141736|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1141737|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141738|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1141739|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141740|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1141741|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141742|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1141743|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141744|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1144221|NCT00450073|E3|Reported Event|Sunlamp|Weekly use of a sunlamp
1141745|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141746|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1141747|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141748|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1141749|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141750|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1141751|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141752|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1141753|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141754|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1141755|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141756|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1141757|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141758|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1141759|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141760|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1141906|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
1141761|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141762|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1141763|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141764|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1141765|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141766|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1141767|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141768|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1141769|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141770|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1141771|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141772|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1141773|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141774|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1141775|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141776|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1141777|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141778|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1141779|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141780|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1141781|NCT00457002|E2|Reported Event|Enox 40mg QD|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
1141782|NCT00457002|E1|Reported Event|Apix 2.5mg BID|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
1141783|NCT00456989|B1|Baseline|Taxotere and Doxil|"Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.~Taxotere: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively.~Doxil: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively."
1141784|NCT00456989|P1|Participant Flow|Taxotere and Doxil|"Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.~Taxotere: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively.~Doxil: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively."
1141785|NCT00456989|O1|Outcome|Taxotere and Doxil|"Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.~Taxotere: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively.~Doxil: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively."
1141813|NCT00456807|P2|Participant Flow|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
1141786|NCT00456989|E1|Reported Event|Taxotere and Doxil|"Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.~Taxotere: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively.~Doxil: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively."
1141787|NCT00456846|B3|Baseline|Total|Total of all reporting groups
1141788|NCT00456846|B2|Baseline|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
1141789|NCT00456846|B1|Baseline|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
1141790|NCT00456846|P2|Participant Flow|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest. Therapy continued until disease progression or unacceptable toxicity.
1141791|NCT00456846|P1|Participant Flow|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest. Therapy continued until disease progression or unacceptable toxicity.
1141792|NCT00456846|O2|Outcome|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
1141793|NCT00456846|O1|Outcome|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
1141794|NCT00456846|O2|Outcome|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
1141795|NCT00456846|O1|Outcome|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
1141796|NCT00456846|O2|Outcome|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
1141797|NCT00456846|O1|Outcome|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
1149014|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
1141798|NCT00456846|O2|Outcome|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
1141799|NCT00456846|O1|Outcome|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
1141800|NCT00456846|O2|Outcome|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
1141801|NCT00456846|O1|Outcome|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
1141802|NCT00456846|O2|Outcome|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
1141803|NCT00456846|O1|Outcome|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
1141804|NCT00456846|O2|Outcome|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
1141805|NCT00456846|O1|Outcome|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
1141806|NCT00456846|O2|Outcome|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
1141807|NCT00456846|O1|Outcome|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
1141808|NCT00456846|E2|Reported Event|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
1141809|NCT00456846|E1|Reported Event|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
1141810|NCT00456807|B3|Baseline|Total|Total of all reporting groups
1141811|NCT00456807|B2|Baseline|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
1141812|NCT00456807|B1|Baseline|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
1141814|NCT00456807|P1|Participant Flow|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
1141815|NCT00456807|O2|Outcome|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
1141816|NCT00456807|O1|Outcome|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
1141817|NCT00456807|O2|Outcome|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
1141818|NCT00456807|O1|Outcome|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
1141819|NCT00456807|O2|Outcome|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
1141820|NCT00456807|O1|Outcome|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
1141821|NCT00456807|O2|Outcome|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
1141822|NCT00456807|O1|Outcome|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
1141823|NCT00456807|O2|Outcome|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
1141824|NCT00456807|O1|Outcome|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
1141825|NCT00456807|O2|Outcome|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
1141826|NCT00456807|O1|Outcome|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
1141827|NCT00456807|E2|Reported Event|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
1141828|NCT00456807|E1|Reported Event|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
1141829|NCT00456755|B3|Baseline|Total|Total of all reporting groups
1141830|NCT00456755|B2|Baseline|Placebo|The placebo contained brown colored starch resembling the SBL powder
1141831|NCT00456755|B1|Baseline|Shi-Bi-Lin|Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba).
1141832|NCT00456755|P2|Participant Flow|Placebo|The placebo contained brown colored starch resembling the SBL powder
1141833|NCT00456755|P1|Participant Flow|Shi-Bi-Lin|Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba).
1141834|NCT00456755|O2|Outcome|Placebo|The placebo contained brown colored starch resembling the SBL powder
1141866|NCT00456547|O2|Outcome|Cesarean Delivery Case Controls|Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
1141867|NCT00456547|O1|Outcome|Postpartum Hysterectomy|Women that require postpartum hysterectomy for post-delivery bleeding.
1141835|NCT00456755|O1|Outcome|Shi-Bi-Lin|Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba).
1141836|NCT00456755|O2|Outcome|Placebo|The placebo contained brown colored starch resembling the SBL powder
1141837|NCT00456755|O1|Outcome|Shi-Bi-Lin|Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba).
1141838|NCT00456755|E2|Reported Event|Placebo|The placebo contained brown colored starch resembling the SBL powder
1141839|NCT00456755|E1|Reported Event|Shi-Bi-Lin|Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba).
1141840|NCT00456625|B1|Baseline|Group Engerix™-B|Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
1141841|NCT00456625|P1|Participant Flow|Group Engerix™-B|Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
1141842|NCT00456625|O1|Outcome|Group Engerix™-B|Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
1141843|NCT00456625|O1|Outcome|Group Engerix™-B|Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
1141844|NCT00456625|O1|Outcome|Group Engerix™-B|Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
1141845|NCT00456625|E1|Reported Event|Group Engerix™-B|Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
1141846|NCT00456612|B1|Baseline|Single Arm|Single arm Phase II Study
1141847|NCT00456612|P1|Participant Flow|Cyberknife|Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses.
1141848|NCT00456612|O1|Outcome|Single Arm|Single arm Phase II Study
1141849|NCT00456612|O1|Outcome|Cyberknife|"Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses.~CyberKnife: Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses."
1141850|NCT00456612|E1|Reported Event|Single Arm Study|Single arm Phase II Study
1141851|NCT00456599|B1|Baseline|Oxaliplatin & Gemcitabine With Radiation|Protocol treatment consisted of four 28 day cycles of chemotherapy: 2 cycles before surgery and 2 cycles before surgery and 2 cycles after. Gemcitabine (1 g/m2 infused over 30 minutes) was administered on days 1, 8, and 15 of each cycle; oxaliplatin (85 mg/m2 infused over 90 minutes) was administered on days 1 and 15. Radiation therapy was delivered concurrently with the first cycle of chemotherapy in 2-Gray [Gy] fractions (total dose, 30 Gy).
1141852|NCT00456599|P1|Participant Flow|Gemcitabine and Oxaliplatin With Radiation Therapy|Gemcitabine and Oxaliplatin with radiation therapy in localized pancreatic cancer.
1141905|NCT00456521|O2|Outcome|Placebo|Placebo
1141853|NCT00456599|O1|Outcome|Oxaliplatin & Gemcitabine With Radiation|Protocol treatment consisted of four 28 day cycles of chemotherapy: 2 cycles before surgery and 2 cycles before surgery and 2 cycles after. Gemcitabine (1 g/m2 infused over 30 minutes) was administered on days 1, 8, and 15 of each cycle; oxaliplatin (85 mg/m2 infused over 90 minutes) was administered on days 1 and 15. Radiation therapy was delivered concurrently with the first cycle of chemotherapy in 2-Gray [Gy] fractions (total dose, 30 Gy).
1141854|NCT00456599|O1|Outcome|Oxaliplatin & Gemcitabine With Radiation|Protocol treatment consisted of four 28 day cycles of chemotherapy: 2 cycles before surgery and 2 cycles before surgery and 2 cycles after. Gemcitabine (1 g/m2 infused over 30 minutes) was administered on days 1, 8, and 15 of each cycle; oxaliplatin (85 mg/m2 infused over 90 minutes) was administered on days 1 and 15. Radiation therapy was delivered concurrently with the first cycle of chemotherapy in 2-Gray [Gy] fractions (total dose, 30 Gy).
1141855|NCT00456599|O1|Outcome|Oxaliplatin & Gemcitabine With Radiation|Protocol treatment consisted of four 28 day cycles of chemotherapy: 2 cycles before surgery and 2 cycles before surgery and 2 cycles after. Gemcitabine (1 g/m2 infused over 30 minutes) was administered on days 1, 8, and 15 of each cycle; oxaliplatin (85 mg/m2 infused over 90 minutes) was administered on days 1 and 15. Radiation therapy was delivered concurrently with the first cycle of chemotherapy in 2-Gray [Gy] fractions (total dose, 30 Gy).
1141856|NCT00456599|E1|Reported Event|Oxaliplatin & Gemcitabine With Radiation|Protocol treatment consisted of four 28 day cycles of chemotherapy: 2 cycles before surgery and 2 cycles before surgery and 2 cycles after. Gemcitabine (1 g/m2 infused over 30 minutes) was administered on days 1, 8, and 15 of each cycle; oxaliplatin (85 mg/m2 infused over 90 minutes) was administered on days 1 and 15. Radiation therapy was delivered concurrently with the first cycle of chemotherapy in 2-Gray [Gy] fractions (total dose, 30 Gy).
1141857|NCT00456547|B3|Baseline|Total|Total of all reporting groups
1141858|NCT00456547|B2|Baseline|Cesarean Delivery Case Controls|Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
1141859|NCT00456547|B1|Baseline|Postpartum Hysterectomy|Women that require postpartum hysterectomy for post-delivery bleeding.
1141860|NCT00456547|P2|Participant Flow|Cesarean Delivery Case Controls|Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
1141861|NCT00456547|P1|Participant Flow|Postpartum Hysterectomy|Women that require postpartum hysterectomy for post-delivery bleeding.
1141862|NCT00456547|O2|Outcome|Cesarean Delivery Case Controls|Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
1141863|NCT00456547|O1|Outcome|Postpartum Hysterectomy|Women that require postpartum hysterectomy for post-delivery bleeding.
1141864|NCT00456547|O2|Outcome|Cesarean Delivery Case Controls|Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
1141865|NCT00456547|O1|Outcome|Postpartum Hysterectomy|Women that require postpartum hysterectomy for post-delivery bleeding.
1141868|NCT00456547|O2|Outcome|Cesarean Delivery Case Controls|Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
1141869|NCT00456547|O1|Outcome|Postpartum Hysterectomy|Women that require postpartum hysterectomy for post-delivery bleeding.
1141870|NCT00456547|E2|Reported Event|Cesarean Delivery Case Controls|Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
1141871|NCT00456547|E1|Reported Event|Postpartum Hysterectomy|Women that require postpartum hysterectomy for post-delivery bleeding.
1141872|NCT00456521|B3|Baseline|Total|Total of all reporting groups
1141873|NCT00456521|B2|Baseline|Placebo|Placebo
1141874|NCT00456521|B1|Baseline|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
1141875|NCT00456521|P2|Participant Flow|Placebo|Placebo
1141876|NCT00456521|P1|Participant Flow|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
1141877|NCT00456521|O2|Outcome|Placebo|Placebo
1141878|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
1141879|NCT00456521|O2|Outcome|Placebo|Placebo
1141880|NCT00456521|O1|Outcome|NB32|"Naltrexone SR 32 mg/ bupropion SR 360 mg/ day with intensive group behavioral lifestyle modification counseling~naltrexone SR/bupropion SR combination~Intensive group lifestyle modification counseling: Group lifestyle modification counseling"
1141881|NCT00456521|O2|Outcome|Placebo|Placebo
1141882|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
1141883|NCT00456521|O2|Outcome|Placebo|Placebo
1141884|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
1141885|NCT00456521|O2|Outcome|Placebo|Placebo
1141886|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
1141887|NCT00456521|O2|Outcome|Placebo|Placebo
1141888|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
1141889|NCT00456521|O2|Outcome|Placebo|Placebo
1141890|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
1141891|NCT00456521|O2|Outcome|Placebo|Placebo
1141892|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
1141893|NCT00456521|O2|Outcome|Placebo|Placebo
1141894|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
1141895|NCT00456521|O2|Outcome|Placebo|Placebo
1141896|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
1141897|NCT00456521|O2|Outcome|Placebo|Placebo
1141898|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
1141899|NCT00456521|O2|Outcome|Placebo|Placebo
1141900|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
1141901|NCT00456521|O2|Outcome|Placebo|Placebo
1141902|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
1141903|NCT00456521|O2|Outcome|Placebo|Placebo
1141904|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
1141908|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
1141909|NCT00456521|O2|Outcome|Placebo|Placebo
1141910|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
1141911|NCT00456521|O2|Outcome|Placebo|Placebo
1141912|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
1141913|NCT00456521|E2|Reported Event|Placebo|Placebo
1141914|NCT00456521|E1|Reported Event|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
1141915|NCT00456508|B1|Baseline|Treatment|DX-88 (ecallantide)
1141916|NCT00456508|P1|Participant Flow|DX-88 (Ecallantide)|Patients were treated with DX-88 (ecallantide) when they experienced an HAE attack. 30 mg dose of ecallantide given via 3 SC injections; a second 30 mg dose can be administered if needed. Patients were to be assessed until 4 hrs post-dose. Patients were asked to return for 3 follow-up visits: 7 days, 28 days and 90 days post-dose.
1141917|NCT00456508|O1|Outcome|DX-88 (Ecallantide)|Patients were treated with DX-88 (ecallantide) when they experienced an HAE attack. 30 mg dose of ecallantide given via 3 SC injections; a second 30 mg dose can be administered if needed. Patients were to be assessed until 4 hrs post-dose. Patients were asked to return for 3 follow-up visits: 7 days, 28 days and 90 days post-dose.
1141918|NCT00456508|O1|Outcome|DX-88 (Ecallantide)|Patients were treated with DX-88 (ecallantide) when they experienced an HAE attack. 30 mg dose of ecallantide given via 3 SC injections; a second 30 mg dose can be administered if needed. Patients were to be assessed until 4 hrs post-dose. Patients were asked to return for 3 follow-up visits: 7 days, 28 days and 90 days post-dose.
1141919|NCT00456508|O1|Outcome|DX-88 (Ecallantide)|Patients were treated with DX-88 (ecallantide) when they experienced an HAE attack. 30 mg dose of ecallantide given via 3 SC injections; a second 30 mg dose can be administered if needed. Patients were to be assessed until 4 hrs post-dose. Patients were asked to return for 3 follow-up visits: 7 days, 28 days and 90 days post-dose.
1141920|NCT00456508|E1|Reported Event|Treatment|DX-88 (ecallantide)
1141921|NCT00456495|B1|Baseline|Squamous Carcinoma of Conjunctiva|Subconjunctival 0.5 mg ranibizumab
1141922|NCT00456495|P1|Participant Flow|Squamous Carcinoma of Conjunctiva|Subconjunctival 0.5 mg ranibizumab
1141923|NCT00456495|O1|Outcome|Open Label Treatment|Patients will receive treatment every 2-4 weeks
1141924|NCT00456495|E1|Reported Event|Squamous Carcinoma of Conjunctiva|Subconjunctival 0.5 mg ranibizumab
1141925|NCT00456261|B3|Baseline|Total|Total of all reporting groups
1141926|NCT00456261|B2|Baseline|Bevacizumab/Pemetrexed/Carboplatin|Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
1141941|NCT00456014|O1|Outcome|Tricyclic Group|7 participants who did not remit during the SSRI phase advanced to the tricyclic phase. 4 participants completed this phase.
1141942|NCT00456014|O1|Outcome|1 - SSRI|Participants will take escitalopram.
1149015|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
1141927|NCT00456261|B1|Baseline|Bevacizumab/Pemetrexed/Gemcitabine|Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
1141928|NCT00456261|P2|Participant Flow|Bevacizumab/Pemetrexed/Carboplatin|Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
1141929|NCT00456261|P1|Participant Flow|Bevacizumab/Pemetrexed/Gemcitabine|Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
1141930|NCT00456261|O2|Outcome|Bevacizumab/Pemetrexed/Carboplatin|Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
1141931|NCT00456261|O1|Outcome|Bevacizumab/Pemetrexed/Gemcitabine|Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
1141932|NCT00456261|O2|Outcome|Bevacizumab/Pemetrexed/Carboplatin|Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
1141933|NCT00456261|O1|Outcome|Bevacizumab/Pemetrexed/Gemcitabine|Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
1141934|NCT00456261|O2|Outcome|Bevacizumab/Pemetrexed/Carboplatin|Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
1141935|NCT00456261|O1|Outcome|Bevacizumab/Pemetrexed/Gemcitabine|Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
1141936|NCT00456261|E2|Reported Event|Bevacizumab/Pemetrexed/Carboplatin|Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
1141937|NCT00456261|E1|Reported Event|Bevacizumab/Pemetrexed/Gemcitabine|Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
1141938|NCT00456014|B1|Baseline|SSRI|The single arm of this study involves patients with current MDD who will all receive open standardized treatment with escitalopram. There are not multiple arms nor multiple patient groups.
1141939|NCT00456014|P1|Participant Flow|Open Standardized Treatment|"Participants will take escitalopram through standardized dosing over an 8 week trial. Non-remitters will be offered entry into a second open treatment phase with standardized treatment with desipramine.~In phase 1, participants will receive escitalopram beginning at 10mg daily for 4 weeks, increasing to 20mg if non-response at week 4 or 6. If participants experience intolerable side-effects, they will be switched to an alternative SSRI, sertraline. Non-remitters after 8 weeks may enter a second phase of standardized treatment, switching from escitalopram to desipramine, dosed by blood level according to a treatment protocol. Those with intolerable side-effects to desipramine will be switched to an alternative tricyclic antidepressant, nortriptyline."
1141940|NCT00456014|O1|Outcome|1 - SSRI|Participants will take escitalopram.
1141945|NCT00455975|B2|Baseline|Bi-weekly Avastin|"Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity~Bevacizumab: Bevacizumab"
1141946|NCT00455975|B1|Baseline|Weekly Avastin|"Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity~Bevacizumab: Bevacizumab"
1141947|NCT00455975|P2|Participant Flow|Bi-weekly Avastin|"Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity~Bevacizumab: Bevacizumab"
1141948|NCT00455975|P1|Participant Flow|Weekly Avastin|"Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity~Bevacizumab: Bevacizumab"
1141949|NCT00455975|O2|Outcome|Bi-weekly Avastin|"Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity~Bevacizumab: Bevacizumab"
1141950|NCT00455975|O1|Outcome|Weekly Avastin|"Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity~Bevacizumab: Bevacizumab"
1141951|NCT00455975|O2|Outcome|Bi-weekly Avastin|"Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity~Bevacizumab: Bevacizumab"
1141952|NCT00455975|O1|Outcome|Weekly Avastin|"Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity~Bevacizumab: Bevacizumab"
1141953|NCT00455975|O2|Outcome|Bi-weekly Avastin|"Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity~Bevacizumab: Bevacizumab"
1141954|NCT00455975|O1|Outcome|Weekly Avastin|"Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity~Bevacizumab: Bevacizumab"
1141955|NCT00455975|O2|Outcome|Bi-weekly Avastin|"Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity~Bevacizumab: Bevacizumab"
1141956|NCT00455975|O1|Outcome|Weekly Avastin|"Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity~Bevacizumab: Bevacizumab"
1141957|NCT00455975|E2|Reported Event|Bi-weekly Avastin|"Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity~Bevacizumab: Bevacizumab"
1141958|NCT00455975|E1|Reported Event|Weekly Avastin|"Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity~Bevacizumab: Bevacizumab"
1141959|NCT00455962|B3|Baseline|Total|Total of all reporting groups
1141960|NCT00455962|B2|Baseline|Caucasian Women|"Healthy Caucasian women 18-35 years old~Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr~Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr"
1141961|NCT00455962|B1|Baseline|African American Women|"Healthy African-American women 18-35 years old~Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr~Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr"
1141962|NCT00455962|P2|Participant Flow|Caucasian Women|"Healthy Caucasian women 18-35 years old~Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr~Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr"
1145184|NCT00446641|O2|Outcome|Placebo|matching placebo to cilostazol
1141963|NCT00455962|P1|Participant Flow|African American Women|"Healthy African-American women 18-35 years old~Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr~Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr"
1141964|NCT00455962|O2|Outcome|Caucasian Women|"Healthy Caucasian women 18-35 years old~Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr~Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr"
1141965|NCT00455962|O1|Outcome|African American Women|"Healthy African-American women 18-35 years old~Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr~Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr"
1141966|NCT00455962|E2|Reported Event|Caucasian Women|"Healthy Caucasian women 18-35 years old~Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr~Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr"
1141967|NCT00455962|E1|Reported Event|African American Women|"Healthy African-American women 18-35 years old~Estradiol steroid infusion: Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr~Progesterone steroid infusion: Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr"
1141968|NCT00454909|B4|Baseline|Total|Total of all reporting groups
1141969|NCT00454909|B3|Baseline|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1141970|NCT00454909|B2|Baseline|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1141971|NCT00454909|B1|Baseline|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1141972|NCT00454909|P3|Participant Flow|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1141973|NCT00454909|P2|Participant Flow|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1141974|NCT00454909|P1|Participant Flow|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1141975|NCT00454909|O3|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1144222|NCT00450073|E2|Reported Event|Vitamin D2|vitamin D2 50,000 IU weekly
1141976|NCT00454909|O2|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1141977|NCT00454909|O1|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1141978|NCT00454909|O3|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1141979|NCT00454909|O2|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1141980|NCT00454909|O1|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1141981|NCT00454909|O3|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1141982|NCT00454909|O2|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1141983|NCT00454909|O1|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1141984|NCT00454909|O3|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1141985|NCT00454909|O2|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1141986|NCT00454909|O1|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1141987|NCT00454909|O3|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1141988|NCT00454909|O2|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received on dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1141989|NCT00454909|O1|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1141990|NCT00454909|O3|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1141991|NCT00454909|O2|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1141992|NCT00454909|O1|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1141993|NCT00454909|O3|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1141994|NCT00454909|O2|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1141995|NCT00454909|O1|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1141996|NCT00454909|O3|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1141997|NCT00454909|O2|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1141998|NCT00454909|O1|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1141999|NCT00454909|O3|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1142000|NCT00454909|O2|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1142001|NCT00454909|O1|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1142002|NCT00454909|O3|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1142003|NCT00454909|O2|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received on dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1142004|NCT00454909|O1|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1142005|NCT00454909|O3|Outcome|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1142006|NCT00454909|O2|Outcome|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1142007|NCT00454909|O1|Outcome|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1149016|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
1142008|NCT00454909|E3|Reported Event|Nimenrix 10Y Group|Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1142009|NCT00454909|E2|Reported Event|Menactra Group|Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1142010|NCT00454909|E1|Reported Event|Nimenrix 11-25Y Group|Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
1142011|NCT00454857|B1|Baseline|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
1142012|NCT00454857|P1|Participant Flow|Patients With ITP|Patients diagnosed with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) were followed prospectively for a period of 12 months.
1142013|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
1142014|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
1142015|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
1142016|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
1142017|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
1142018|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
1142019|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
1142020|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
1142021|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
1142022|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
1142023|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
1142024|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
1142025|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
1142026|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
1142027|NCT00454857|E1|Reported Event|Overall Study|
1142028|NCT00454818|B9|Baseline|Total|Total of all reporting groups
1142029|NCT00454818|B8|Baseline|Phase 2: Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
1142030|NCT00454818|B7|Baseline|Phase 2: MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
1145185|NCT00446641|O1|Outcome|Cilostazol|Cilostazol 100mg twice per day
1142031|NCT00454818|B6|Baseline|Phase 2: MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
1142032|NCT00454818|B5|Baseline|Phase 2: MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
1142033|NCT00454818|B4|Baseline|Phase 1: MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
1142034|NCT00454818|B3|Baseline|Phase 1: MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
1142035|NCT00454818|B2|Baseline|Phase 1: MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
1142036|NCT00454818|B1|Baseline|Phase 1: MYDICAR® Very Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1.4E11 DRP administered by antegrade epicardial coronary artery infusion.
1142037|NCT00454818|P5|Participant Flow|Placebo|"Single dose of placebo administered by antegrade epicardial coronary artery infusion.~The placebo arm was included only in the Phase 2 randomized double-blind period."
1142038|NCT00454818|P4|Participant Flow|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DNAase resistant particles (DRP) administered by antegrade epicardial coronary artery infusion.
1142039|NCT00454818|P3|Participant Flow|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DNAase resistant particles (DRP) administered by antegrade epicardial coronary artery infusion.
1142040|NCT00454818|P2|Participant Flow|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DNAase resistant particles (DRP) administered by antegrade epicardial coronary artery infusion.
1142041|NCT00454818|P1|Participant Flow|MYDICAR® Very Low Dose|"Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1.4E11 DNAase resistant particles (DRP) administered by antegrade epicardial coronary artery infusion.~This arm was included only in the Phase I open-label dose-escalation period."
1149017|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
1142042|NCT00454818|O6|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
1142043|NCT00454818|O5|Outcome|All MYDICAR®|All participants who received a single infusion of MYDICAR® at any dose during the Phase 1 or Phase 2 studies.
1142044|NCT00454818|O4|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
1142045|NCT00454818|O3|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
1142046|NCT00454818|O2|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
1142047|NCT00454818|O1|Outcome|MYDICAR® Very Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1.4E11 DRP administered by antegrade epicardial coronary artery infusion.
1142048|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
1142049|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
1142050|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
1142051|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
1142052|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
1142053|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
1142054|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
1142055|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
1142056|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
1142057|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
1142058|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
1142059|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
1142060|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
1142061|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
1142062|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
1142063|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
1142064|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
1142065|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
1142066|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
1142067|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
1142068|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
1142069|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
1142070|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
1142071|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
1142072|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
1142073|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
1142074|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
1142075|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
1142076|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
1142077|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
1142078|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
1142079|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
1142080|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
1142081|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
1142082|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
1142083|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
1142084|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
1142085|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
1142086|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
1142087|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
1142088|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
1142089|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
1142090|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
1142091|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
1142092|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
1142093|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
1142094|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
1142095|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
1142096|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
1142160|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
1142161|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
1142097|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
1142098|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
1142099|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
1142100|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
1142101|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
1142102|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
1142103|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
1142104|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
1142105|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
1142106|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
1142107|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
1142108|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
1142109|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
1142110|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
1142185|NCT00455663|B3|Baseline|Treatment As Usual|Medication follow up and limited case management provided by local mental health authority
1145186|NCT00446641|O2|Outcome|Placebo|matching placebo to cilostazol
1142111|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
1142112|NCT00454818|E5|Reported Event|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
1142113|NCT00454818|E4|Reported Event|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
1142114|NCT00454818|E3|Reported Event|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
1142115|NCT00454818|E2|Reported Event|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11DRP administered by antegrade epicardial coronary artery infusion.
1142116|NCT00454818|E1|Reported Event|MYDICAR® Very Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1.4E11DRP administered by antegrade epicardial coronary artery infusion.
1142117|NCT00454805|B3|Baseline|Total|Total of all reporting groups
1142118|NCT00454805|B2|Baseline|Placebo|"Placebo+Fulvestrant 250 mg~Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: placebo to match cediranib (administered orally)"
1142119|NCT00454805|B1|Baseline|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg~Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: cediranib 45 mg (administered orally)"
1142120|NCT00454805|P2|Participant Flow|Placebo|"Placebo+Fulvestrant 250 mg~Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: placebo to match cediranib (administered orally)"
1142121|NCT00454805|P1|Participant Flow|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg~Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: cediranib 45 mg (administered orally)"
1142122|NCT00454805|O2|Outcome|Placebo|"Placebo+Fulvestrant 250 mg~Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: placebo to match cediranib (administered orally)"
1142123|NCT00454805|O1|Outcome|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg~Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: cediranib 45 mg (administered orally)"
1142124|NCT00454805|O2|Outcome|Placebo|"Placebo+Fulvestrant 250 mg~Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: placebo to match cediranib (administered orally)"
1142125|NCT00454805|O1|Outcome|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg~Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: cediranib 45 mg (administered orally)"
1142126|NCT00454805|O2|Outcome|Placebo|"Placebo+Fulvestrant 250 mg~Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: placebo to match cediranib (administered orally)"
1142127|NCT00454805|O1|Outcome|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg~Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: cediranib 45 mg (administered orally)"
1142128|NCT00454805|O2|Outcome|Placebo|"Placebo+Fulvestrant 250 mg~Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: placebo to match cediranib (administered orally)"
1142129|NCT00454805|O1|Outcome|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg~Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: cediranib 45 mg (administered orally)"
1142130|NCT00454805|O2|Outcome|Placebo|"Placebo+Fulvestrant 250 mg~Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: placebo to match cediranib (administered orally)"
1142131|NCT00454805|O1|Outcome|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg~Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: cediranib 45 mg (administered orally)"
1142132|NCT00454805|E2|Reported Event|Placebo|"Placebo+Fulvestrant 250 mg~Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: placebo to match cediranib (administered orally)"
1145187|NCT00446641|O1|Outcome|Cilostazol|Cilostazol 100mg twice per day
1142133|NCT00454805|E1|Reported Event|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg~Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: cediranib 45 mg (administered orally)"
1142134|NCT00454779|B3|Baseline|Total|Total of all reporting groups
1142135|NCT00454779|B2|Baseline|Chemotherapy Alone|Docetaxel + Cisplatin, control
1142136|NCT00454779|B1|Baseline|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
1142137|NCT00454779|P2|Participant Flow|Chemotherapy Alone|Docetaxel + Cisplatin, control
1142138|NCT00454779|P1|Participant Flow|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
1142139|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
1142140|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
1142141|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
1142142|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
1142143|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
1142144|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
1142145|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
1142146|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
1142147|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
1142148|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
1142149|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
1142150|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
1142151|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
1142152|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
1142153|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
1142154|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
1142155|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
1142156|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
1142157|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
1142158|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
1142159|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
1142162|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
1142163|NCT00454779|E2|Reported Event|Chemotherapy Alone|Docetaxel + Cisplatin, control
1142164|NCT00454779|E1|Reported Event|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
1142165|NCT00455858|B1|Baseline|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
1142166|NCT00455858|P1|Participant Flow|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
1142167|NCT00455858|O1|Outcome|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
1142168|NCT00455858|O1|Outcome|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
1142169|NCT00455858|O1|Outcome|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
1142170|NCT00455858|O1|Outcome|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
1142171|NCT00455858|O1|Outcome|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
1142172|NCT00455858|E1|Reported Event|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
1142173|NCT00455702|B3|Baseline|Total|Total of all reporting groups
1142174|NCT00455702|B2|Baseline|Placebo|50 mg placebo
1142175|NCT00455702|B1|Baseline|D-cycloserine|50 mg d-cycloserine
1142176|NCT00455702|P2|Participant Flow|Placebo|50 mg placebo
1142177|NCT00455702|P1|Participant Flow|D-cycloserine|50 mg d-cycloserine
1142178|NCT00455702|O2|Outcome|Placebo|"50 mg placebo~d-cycloserine: 50mg dose d-cycloserine v placebo"
1142179|NCT00455702|O1|Outcome|D-cycloserine|"50 mg d-cycloserine~d-cycloserine: 50mg dose d-cycloserine v placebo"
1142180|NCT00455702|O2|Outcome|Placebo|50 mg placebo
1142181|NCT00455702|O1|Outcome|D-cycloserine|50 mg d-cycloserine
1142182|NCT00455702|E2|Reported Event|Placebo|50 mg placebo
1142183|NCT00455702|E1|Reported Event|D-cycloserine|50 mg d-cycloserine
1142184|NCT00455663|B4|Baseline|Total|Total of all reporting groups
1142186|NCT00455663|B2|Baseline|Pharm-Cognitive Adaptation Training|Uses Supports from Cognitive Adaptation Training designed only to promote adherence to medication and treatment follow up.
1142187|NCT00455663|B1|Baseline|Cognitive Adaptation Training|In home treatment using environmental supports such as signs, labels, alarms, checklists and the organization of belongings to bypass cognitive impairment, cue and sequence adaptive behavior and improve a wide range of functional outcomes.
1142188|NCT00455663|P3|Participant Flow|Treatment As Usual|Medication follow up and limited case management provided by local mental health authority
1142189|NCT00455663|P2|Participant Flow|Pharm-Cognitive Adaptation Training|Uses Supports from Cognitive Adaptation Training designed only to promote adherence to medication and treatment follow up.
1142190|NCT00455663|P1|Participant Flow|Cognitive Adaptation Training|In home treatment using environmental supports such as signs, labels, alarms, checklists and the organization of belongings to bypass cognitive impairment, cue and sequence adaptive behavior and improve a wide range of functional outcomes.
1142191|NCT00455663|O3|Outcome|Treatment as Usual|Medication management and case management at a community mental health center
1142192|NCT00455663|O2|Outcome|Pharm-Cognitive Adaptation Training|Environmental supports for medication and appointment adherence
1142193|NCT00455663|O1|Outcome|Cognitive Adaptation Training|Environmental supports for all independent living skills
1142194|NCT00455663|O3|Outcome|Treatment as Usual|medication management and case management at a community mental health center
1142195|NCT00455663|O2|Outcome|Pharm-Cognitive Adaptation Training|Environmental supports for medication and appointment adherence
1142196|NCT00455663|O1|Outcome|Cognitive Adaptation Training|Environmental supports for all independent living skills
1142197|NCT00455663|O3|Outcome|Treatment as Usual|medication management and case management at a community mental health center
1142198|NCT00455663|O2|Outcome|Pharm-Cognitive Adaptation Training|Environmental supports for medication and appointment adherence
1142199|NCT00455663|O1|Outcome|Cognitive Adaptation Training|Environmental supports for all independent living skills
1142200|NCT00455663|O3|Outcome|Treatment as Usual|medication management and case management in the community mental health center
1142201|NCT00455663|O2|Outcome|Cognitive Adaptation Training|Environmental supports for all independent living skills
1142202|NCT00455663|O1|Outcome|Pharm-Cognitive Adaptation Training|Environmental supports to assist in medication and appointment adherence
1142203|NCT00455663|E3|Reported Event|Treatment As Usual|Medication follow up and limited case management provided by local mental health authority
1142204|NCT00455663|E2|Reported Event|Pharm-Cognitive Adaptation Training|Uses Supports from Cognitive Adaptation Training designed only to promote adherence to medication and treatment follow up.
1142205|NCT00455663|E1|Reported Event|Cognitive Adaptation Training|In home treatment using environmental supports such as signs, labels, alarms, checklists and the organization of belongings to bypass cognitive impairment, cue and sequence adaptive behavior and improve a wide range of functional outcomes.
1142207|NCT00455650|B2|Baseline|Control|Healthy volunteers were recruited through media advertisements in the greater Boston area and had no lifetime history of Axis I disorders by SCID interview and no firstdegree relatives with Axis I disorders by history
1142208|NCT00455650|B1|Baseline|Schizophrenia|Study participants in the schizophrenia group were clinically stable, outpatient, non-smokers with schizophrenia on a stable, clinically determined dose of antipsychotic medication for at least 4 weeks, which were recruited from an urban community mental health clinic in Boston. Diagnoses were confirmed by clinical interview and medical record review
1142209|NCT00455650|P6|Participant Flow|Control: Varenicline (Wk1), Placebo (Wk2), Mecamylamine (Wk3)|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
1142210|NCT00455650|P5|Participant Flow|Control: Placebo (Wk1), Mecamylamine (Wk2), Varenicline (Wk3)|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
1142211|NCT00455650|P4|Participant Flow|Control: Mecamylamine (Wk1),Varenicline (Wk2), Placebo (Wk3)|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
1142212|NCT00455650|P3|Participant Flow|Schizoph: Varenicline (Wk1), Placebo (Wk2), Mecamylamine (Wk3)|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
1142213|NCT00455650|P2|Participant Flow|Schizoph: Placebo (Wk1), Mecamylamine (Wk2), Varenicline (Wk3)|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
1142214|NCT00455650|P1|Participant Flow|Schizoph: Mecamylamine (Wk1),Varenicline (Wk2), Placebo (Wk3)|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
1142215|NCT00455650|O6|Outcome|Control: Placebo|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
1147569|NCT00441545|O2|Outcome|Sevelamer HCl|
1142216|NCT00455650|O5|Outcome|Control: Varenicline|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
1142217|NCT00455650|O4|Outcome|Control: Mecamylamine|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
1142218|NCT00455650|O3|Outcome|Schizophrenia: Placebo|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
1142219|NCT00455650|O2|Outcome|Schizophrenia: Varenicline|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
1142220|NCT00455650|O1|Outcome|Schizophrenia: Mecamylamine|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
1142221|NCT00455650|O6|Outcome|Control: Placebo|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
1142222|NCT00455650|O5|Outcome|Control: Varenicline|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
1142223|NCT00455650|O4|Outcome|Control: Mecamylamine|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
1142224|NCT00455650|O3|Outcome|Schizophrenia: Placebo|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
1142225|NCT00455650|O2|Outcome|Schizophrenia: Varenicline|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
1142226|NCT00455650|O1|Outcome|Schizophrenia: Mecamylamine|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
1142227|NCT00455650|O6|Outcome|Control: Placebo|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
1142228|NCT00455650|O5|Outcome|Control: Varenicline|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
1142229|NCT00455650|O4|Outcome|Control: Mecamylamine|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
1142230|NCT00455650|O3|Outcome|Schizophrenia: Placebo|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
1142231|NCT00455650|O2|Outcome|Schizophrenia: Varenicline|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
1142232|NCT00455650|O1|Outcome|Schizophrenia: Mecamylamine|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
1142233|NCT00455650|O6|Outcome|Control: Placebo|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
1142274|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
1142234|NCT00455650|O5|Outcome|Control: Varenicline|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
1142235|NCT00455650|O4|Outcome|Control: Mecamylamine|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
1142236|NCT00455650|O3|Outcome|Schizophrenia: Placebo|Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
1142237|NCT00455650|O2|Outcome|Schizophrenia: Varenicline|Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
1142238|NCT00455650|O1|Outcome|Schizophrenia: Mecamylamine|Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
1142239|NCT00455650|E2|Reported Event|Control|Healthy volunteers were recruited through media advertisements in the greater Boston area and had no lifetime history of Axis I disorders by SCID interview and no firstdegree relatives with Axis I disorders by history
1142240|NCT00455650|E1|Reported Event|Schizophrenia|Study participants in the schizophrenia group were clinically stable, outpatient, non-smokers with schizophrenia on a stable, clinically determined dose of antipsychotic medication for at least 4 weeks, which were recruited from an urban community mental health clinic in Boston. Diagnoses were confirmed by clinical interview and medical record review
1142241|NCT00455533|B3|Baseline|Total|Total of all reporting groups
1142242|NCT00455533|B2|Baseline|Paclitaxel (Randomized Population)|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
1142243|NCT00455533|B1|Baseline|Ixabepilone (Randomized Population)|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
1142244|NCT00455533|P3|Participant Flow|Paclitaxel|Paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
1142245|NCT00455533|P2|Participant Flow|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
1142246|NCT00455533|P1|Participant Flow|Doxorubicin / Cyclophosphamide (AC)|60 mg/m^2 doxorubicin and 600 mg/m^2 cyclophosphamide (AC) every 3 weeks for 4 cycles (12 weeks).
1149018|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
1142248|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
1142249|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
1142250|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
1142251|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
1142252|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
1142253|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
1142254|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
1142255|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
1142256|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
1142257|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
1142258|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
1142259|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
1142260|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
1142261|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
1142262|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
1142263|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
1142264|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
1142265|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
1142266|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
1142267|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
1142268|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
1142269|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
1142270|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
1142271|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
1142272|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
1142273|NCT00455533|O1|Outcome|Randomized Participants|Randomized Participants with non-missing pCR and biomarker expression
1142275|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
1142276|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
1142277|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
1142278|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
1142279|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
1142280|NCT00455533|O1|Outcome|Randomized Participants|
1142281|NCT00455533|O1|Outcome|Randomized Participants|
1142282|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
1142283|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
1142284|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
1142285|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
1142286|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
1142287|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
1142288|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
1142289|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
1142290|NCT00455533|E2|Reported Event|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
1142291|NCT00455533|E1|Reported Event|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
1142292|NCT00455520|B3|Baseline|Total|Total of all reporting groups
1142293|NCT00455520|B2|Baseline|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
1142294|NCT00455520|B1|Baseline|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
1142295|NCT00455520|P2|Participant Flow|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
1142296|NCT00455520|P1|Participant Flow|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
1142297|NCT00455520|O2|Outcome|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
1142298|NCT00455520|O1|Outcome|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
1142299|NCT00455520|O2|Outcome|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
1149019|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
1142300|NCT00455520|O1|Outcome|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
1142301|NCT00455520|O2|Outcome|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
1142302|NCT00455520|O1|Outcome|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
1142303|NCT00455520|O2|Outcome|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
1142304|NCT00455520|O1|Outcome|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
1142305|NCT00455520|O2|Outcome|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
1142306|NCT00455520|O1|Outcome|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
1142307|NCT00455520|O2|Outcome|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
1142308|NCT00455520|O1|Outcome|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
1142309|NCT00455520|E2|Reported Event|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
1142310|NCT00455520|E1|Reported Event|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
1142311|NCT00455455|B1|Baseline|Entire Study Group|includes groups randomized to use RepleniSH in the 1st period and ReNu in the 2nd period, and first use ReNu and use RepleniSH in the second period.
1142312|NCT00455455|P2|Participant Flow|ReNu First, Then RepleniSH|Following a washout period, use ReNu for lens care in first period and RepleniSH in second period (after the second washout period)
1142313|NCT00455455|P1|Participant Flow|RepleniSH First, Then ReNu|Following a washout period, use RepleniSH for lens care in first period and ReNu in second period (after the second washout period)
1142314|NCT00455455|O2|Outcome|ReNu|use ReNu for lens care in the first period or the second period
1142315|NCT00455455|O1|Outcome|RepleniSH|use RepleniSH for lens care in the first period and the second period
1142316|NCT00455455|O2|Outcome|ReNu|Use ReNu for lens care in either first period or second period
1142317|NCT00455455|O1|Outcome|RepleniSH|use RepleniSH for lens care in either first period or second period
1142318|NCT00455455|O2|Outcome|ReNu|use ReNu for lens care in either first period or second period
1142319|NCT00455455|O1|Outcome|RepleniSH|use RepleniSH for lens care in either first period or second period
1142320|NCT00455455|O2|Outcome|ReNu|use ReNu for lens care in either first period or second period
1142321|NCT00455455|O1|Outcome|RepleniSH|use RepleniSH for lens care in either first period or second period
1142322|NCT00455455|O2|Outcome|ReNu|use ReNu for lens care in either first period or second period
1147570|NCT00441545|O1|Outcome|Fosrenol|Lanthanum carbonate
1142323|NCT00455455|O1|Outcome|RepleniSH|use RepleniSH for lens care in either first period or second period
1142324|NCT00455455|O2|Outcome|ReNu|Use ReNu for lens care in either first period or second period
1142325|NCT00455455|O1|Outcome|RepleniSH|use RepleniSH for lens care in either first period or second period
1142326|NCT00455455|E2|Reported Event|ReNu|use ReNu for lens care in either first period or second period
1142327|NCT00455455|E1|Reported Event|RepleniSH|use RepleniSH for lens care in either first period or second period
1142328|NCT00455429|B5|Baseline|Total|Total of all reporting groups
1142329|NCT00455429|B4|Baseline|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
1142330|NCT00455429|B3|Baseline|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
1142331|NCT00455429|B2|Baseline|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
1142332|NCT00455429|B1|Baseline|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
1142333|NCT00455429|P4|Participant Flow|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
1142334|NCT00455429|P3|Participant Flow|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
1142335|NCT00455429|P2|Participant Flow|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
1142336|NCT00455429|P1|Participant Flow|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
1142337|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
1142338|NCT00455429|O2|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
1142339|NCT00455429|O1|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
1142340|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
1142341|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
1142342|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
1142343|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
1142344|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
1142345|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
1142346|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
1142347|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
1142348|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
1142349|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
1142350|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
1142351|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
1142352|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
1142353|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
1142354|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
1142355|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
1142356|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
1142357|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
1142358|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
1142359|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
1142360|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
1142361|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
1142362|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
1142363|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
1142364|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
1142365|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
1142366|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
1142367|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
1142368|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
1142369|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
1142370|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
1142371|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
1142372|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
1142373|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
1142374|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
1142375|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
1142376|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
1142377|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
1142378|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
1142379|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
1142380|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
1142381|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
1142382|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
1142383|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
1142384|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
1142385|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
1142386|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
1142387|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
1142388|NCT00455429|E4|Reported Event|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
1142389|NCT00455429|E3|Reported Event|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
1142390|NCT00455429|E2|Reported Event|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
1142391|NCT00455429|E1|Reported Event|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
1142392|NCT00455312|B3|Baseline|Total|Total of all reporting groups
1142422|NCT00455195|P2|Participant Flow|Placebo/Alglucosidase Alfa|Participants who received placebo during the double-blind study AGLU02704 (NCT00158600), completed the double-blind study, and started alglucosidase alfa in the extension study. Only participants' experience on alglucosidase alfa in the extension study is represented.
1142832|NCT00454363|O2|Outcome|Pazopanib + pNET|Pancreatic Neuroendocrine (pNET) tumor type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
1142393|NCT00455312|B2|Baseline|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0.~antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.~Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
1142394|NCT00455312|B1|Baseline|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.~Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0."
1142395|NCT00455312|P2|Participant Flow|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin (ATG), total body irradiation and stem cell transplantation.~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0.~antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.~Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
1142396|NCT00455312|P1|Participant Flow|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.~Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0."
1142397|NCT00455312|O2|Outcome|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0.~antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.~Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
1142435|NCT00455195|E1|Reported Event|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
1142436|NCT00455013|B4|Baseline|Total|Total of all reporting groups
1142398|NCT00455312|O1|Outcome|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.~Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0."
1142399|NCT00455312|O2|Outcome|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0.~antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.~Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
1142400|NCT00455312|O1|Outcome|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.~Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0."
1142401|NCT00455312|O2|Outcome|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0.~antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.~Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
1142833|NCT00454363|O1|Outcome|Pazopanib + Carcinoid|Carcinoid Tumor Type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
1142402|NCT00455312|O1|Outcome|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.~Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0."
1142403|NCT00455312|O2|Outcome|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0.~antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.~Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
1142404|NCT00455312|O1|Outcome|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.~Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0."
1142405|NCT00455312|O2|Outcome|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0.~antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.~Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
1142406|NCT00455312|O1|Outcome|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.~Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0."
1142437|NCT00455013|B3|Baseline|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
1142524|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142407|NCT00455312|O2|Outcome|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0.~antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.~Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
1142408|NCT00455312|O1|Outcome|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.~Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0."
1142409|NCT00455312|O2|Outcome|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0.~antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.~Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
1142410|NCT00455312|O1|Outcome|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.~Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0."
1142411|NCT00455312|O2|Outcome|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0.~antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.~Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
1142412|NCT00455312|O1|Outcome|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.~Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0."
1142413|NCT00455312|O2|Outcome|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0.~antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.~Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
1142414|NCT00455312|O1|Outcome|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.~Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0."
1142415|NCT00455312|O2|Outcome|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0.~antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.~Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
1142438|NCT00455013|B2|Baseline|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
1142416|NCT00455312|O1|Outcome|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.~Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0."
1142417|NCT00455312|E2|Reported Event|Patients With SAA|"Patients with severe aplastic anemia (SAA). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, antithymocyte globulin, total body irradiation and stem cell transplantation.~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0.~antithymocyte globulin: ATG (rabbit) 3 mg/kg for 3 days.~Methylprednisolone: 2mg/kg IV is given before each dose of ATG."
1142418|NCT00455312|E1|Reported Event|Patients With DC|"Patients with dyskeratosis congenita (DC). Patients are treated with alemtuzumab (Campath 1H), Cyclophosphamide, Fludarabine, total body irradiation and stem cell transplantation.~Campath 1H: 10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).~Cyclophosphamide: 7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).~Fludarabine: 6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)~Total Body Irradiation: 1 day before the transplant one dose (200 cGy) of total body irradiation is given~Stem Cell Transplantation: Infusion of stem cells on Day 0."
1142419|NCT00455195|B3|Baseline|Total|Total of all reporting groups
1142420|NCT00455195|B2|Baseline|Placebo/Alglucosidase Alfa|Participants who received placebo during the double-blind study AGLU02704 (NCT00158600), completed the double-blind study, and started alglucosidase alfa in the extension study. Only participants' experience on alglucosidase alfa in the extension study is represented.
1142421|NCT00455195|B1|Baseline|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
1142423|NCT00455195|P1|Participant Flow|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
1142424|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
1142425|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
1142426|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
1142427|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
1142428|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
1142429|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
1142430|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
1142431|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
1142432|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
1142433|NCT00455195|E3|Reported Event|Overall|The combined alglucosidase alfa treatment experience from the two treatment groups.
1142434|NCT00455195|E2|Reported Event|Placebo/Alglucosidase Alfa|Participants who received placebo during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double-blind study, started alglucosidase alfa in the extension study. Only participants' experience on alglucosidase alfa in the extension study is represented.
1143516|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1142439|NCT00455013|B1|Baseline|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
1142440|NCT00455013|P3|Participant Flow|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF 1g BID. Background immunosuppressive medications: methylprednisolone administered as 500, 250, 125, and 60 mg IV on Days 1, 2, 3, 4; thymoglobulin 1.5 mg/kg IV infusion on Days 1, 2, 3, 4 up to maximum dose of 6 mg/kg.
1142441|NCT00455013|P2|Participant Flow|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 nanograms per milliliter (ng/mL) for first 6 months, followed by 5 - 10 ng/mL until 12 months. Participants were allowed to switch from sirolimus to MMF. Background immunosuppressive medications: methylprednisolone was administered as 500, 250, 125, and 60 mg IV on Days 1, 2, 3, 4, up to maximum dose of 6 mg/kg.
1142442|NCT00455013|P1|Participant Flow|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; intravenous infusion (IV) belatacept: 10 milligram per kilogram of weight (mg/kg) Day 1 (day of transplant) and Day 5, then every other week through Month 3 (Weeks 2,4,6,8,10,12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until 12 months; MMF (mycophenolate mofetil) 1g twice daily(BID). Participants were allowed to switch from MMF to sirolimus. Background immunosuppressive medications: methylprednisolone administered as 500, 250, 125, and 60 mg IV on Days 1, 2, 3, 4; thymoglobulin 1.5 mg/kg IV infusion on Days 1 (day of transplant), 2, 3, 4, up to maximum dose of 6 mg/kg.
1142443|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
1142507|NCT00454987|B3|Baseline|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142444|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
1142445|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
1142446|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
1142447|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
1142448|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
1142449|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
1142450|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
1142451|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
1142452|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
1142629|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
1143934|NCT00451282|O1|Outcome|Intervention|Injured children receiving Stepped Preventive Care intervention
1142453|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
1142454|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
1142455|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
1142456|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
1142457|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
1142458|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
1142459|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
1142460|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
1142461|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
1142462|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
1142463|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
1142464|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
1142465|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
1142466|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
1142467|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
1142521|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142468|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
1142469|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
1142470|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
1142471|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
1142472|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
1142473|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
1142474|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
1142475|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
1142476|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
1142477|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
1142478|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
1142479|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
1142480|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
1142481|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
1142482|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
1142522|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142483|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
1142484|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
1142485|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
1142486|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
1142487|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
1142488|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
1142489|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
1142490|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
1142491|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
1142492|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
1142493|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
1142494|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
1142495|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
1142496|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
1142497|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
1142523|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142498|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
1142499|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
1142500|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
1142501|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
1142502|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
1142503|NCT00455013|E3|Reported Event|Tacrolimus - MMF|
1142504|NCT00455013|E2|Reported Event|Belatacept - SIRO|
1142505|NCT00455013|E1|Reported Event|Belatacept - MMF|
1142506|NCT00454987|B4|Baseline|Total|Total of all reporting groups
1142817|NCT00454532|O2|Outcome|Level 2|20g/day
1142508|NCT00454987|B2|Baseline|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142509|NCT00454987|B1|Baseline|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142510|NCT00454987|P3|Participant Flow|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142511|NCT00454987|P2|Participant Flow|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142512|NCT00454987|P1|Participant Flow|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142513|NCT00454987|O3|Outcome|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142514|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142515|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142516|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142517|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142518|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142519|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142520|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142525|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142526|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142527|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142528|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142529|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142530|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142531|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142532|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142533|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142534|NCT00454987|O1|Outcome|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142818|NCT00454532|O1|Outcome|Level 1|10g/day
1142819|NCT00454532|O4|Outcome|Level 4|40g/day
1142535|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142536|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142537|NCT00454987|O1|Outcome|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142538|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142539|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142540|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142541|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142542|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142543|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142544|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142545|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142546|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142547|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142630|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
1143935|NCT00451282|O2|Outcome|Usual Care|Injured children receiving usual care
1142548|NCT00454987|O1|Outcome|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142549|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142550|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142551|NCT00454987|O1|Outcome|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142552|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142553|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142554|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142555|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142556|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142820|NCT00454532|O3|Outcome|Level 3|30g/day
1142821|NCT00454532|O2|Outcome|Level 2|20g/day
1142822|NCT00454532|O1|Outcome|Level 1|10g/day
1142557|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142558|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142559|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142560|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142561|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142562|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142563|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142564|NCT00454987|O1|Outcome|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142565|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142566|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142567|NCT00454987|O1|Outcome|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142568|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142569|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142608|NCT00454649|O4|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
1142570|NCT00454987|O1|Outcome|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142571|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142572|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142573|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142574|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142575|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142576|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142577|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142578|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142823|NCT00454532|E4|Reported Event|Level 4|40g/day
1142824|NCT00454532|E3|Reported Event|Level 3|30g/day
1142579|NCT00454987|E3|Reported Event|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142580|NCT00454987|E2|Reported Event|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142581|NCT00454987|E1|Reported Event|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
1142582|NCT00454649|B11|Baseline|Total|Total of all reporting groups
1142583|NCT00454649|B10|Baseline|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
1142584|NCT00454649|B9|Baseline|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
1142585|NCT00454649|B8|Baseline|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
1142586|NCT00454649|B7|Baseline|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
1142587|NCT00454649|B6|Baseline|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
1142588|NCT00454649|B5|Baseline|Axitinib + Docetaxel + Carboplatin (Cohort 4a)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Docetaxel (75 mg/m^2) 60-minute infusion on Day 1 of every cycle. Carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
1142589|NCT00454649|B4|Baseline|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
1142590|NCT00454649|B3|Baseline|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
1142627|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
1142628|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
1142591|NCT00454649|B2|Baseline|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
1142592|NCT00454649|B1|Baseline|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
1142593|NCT00454649|P10|Participant Flow|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
1142594|NCT00454649|P9|Participant Flow|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
1142595|NCT00454649|P8|Participant Flow|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
1142596|NCT00454649|P7|Participant Flow|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
1142825|NCT00454532|E2|Reported Event|Level 2|20g/day
1142826|NCT00454532|E1|Reported Event|Level 1|10g/day
1142827|NCT00454363|B3|Baseline|Total|Total of all reporting groups
1142597|NCT00454649|P6|Participant Flow|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
1142598|NCT00454649|P5|Participant Flow|Axitinib + Docetaxel + Carboplatin (Cohort 4a)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Docetaxel (75 mg/m^2) 60-minute infusion on Day 1 of every cycle. Carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
1142599|NCT00454649|P4|Participant Flow|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
1142600|NCT00454649|P3|Participant Flow|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
1142601|NCT00454649|P2|Participant Flow|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
1142602|NCT00454649|P1|Participant Flow|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
1142603|NCT00454649|O9|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
1142604|NCT00454649|O8|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 18 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
1142605|NCT00454649|O7|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
1142606|NCT00454649|O6|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
1142607|NCT00454649|O5|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
1143517|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1142609|NCT00454649|O3|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
1142610|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
1142611|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/meter square (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
1142612|NCT00454649|O1|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
1142613|NCT00454649|O1|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
1142828|NCT00454363|B2|Baseline|Pazopanib + pNET|Pancreatic Neuroendocrine (pNET) tumor type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
1142614|NCT00454649|O1|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
1142615|NCT00454649|O1|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
1142616|NCT00454649|O1|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
1142617|NCT00454649|O2|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
1142618|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
1142619|NCT00454649|O2|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
1142620|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
1142621|NCT00454649|O2|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
1142622|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
1142623|NCT00454649|O2|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
1142624|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
1142625|NCT00454649|O2|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
1142626|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
1143518|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1142631|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
1142632|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
1142633|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
1142634|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
1142635|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
1142636|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
1142829|NCT00454363|B1|Baseline|Pazopanib + Carcinoid|Carcinoid Tumor Type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
1142637|NCT00454649|O2|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
1142638|NCT00454649|O1|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
1142639|NCT00454649|O2|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
1142640|NCT00454649|O1|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
1142641|NCT00454649|O2|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
1142642|NCT00454649|O1|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
1142643|NCT00454649|O2|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
1142644|NCT00454649|O1|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
1142645|NCT00454649|O2|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
1142646|NCT00454649|O1|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
1142647|NCT00454649|O1|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
1142648|NCT00454649|O1|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
1142649|NCT00454649|O1|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
1142650|NCT00454649|O1|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
1142651|NCT00454649|O1|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
1147571|NCT00441545|O2|Outcome|Sevelamer HCl|
1142652|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
1142653|NCT00454649|O1|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
1142654|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
1142655|NCT00454649|O1|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
1142656|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
1142657|NCT00454649|O1|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
1142658|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
1142659|NCT00454649|O1|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
1142660|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
1144223|NCT00450073|E1|Reported Event|Vitamin D3|vitamin D3 50,000 IU weekly
1142661|NCT00454649|O1|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
1142662|NCT00454649|O9|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
1142663|NCT00454649|O8|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
1142664|NCT00454649|O7|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
1142665|NCT00454649|O6|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
1142666|NCT00454649|O5|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
1142667|NCT00454649|O4|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
1142668|NCT00454649|O3|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
1142669|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
1142670|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
1142671|NCT00454649|O9|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
1142672|NCT00454649|O8|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
1142673|NCT00454649|O7|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
1143519|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1142674|NCT00454649|O6|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
1142675|NCT00454649|O5|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
1142676|NCT00454649|O4|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
1142677|NCT00454649|O3|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
1142678|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
1144224|NCT00449956|B4|Baseline|Total|Total of all reporting groups
1142679|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
1142680|NCT00454649|O9|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
1142681|NCT00454649|O8|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
1142682|NCT00454649|O7|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
1142683|NCT00454649|O6|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
1142684|NCT00454649|O5|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
1142685|NCT00454649|O4|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
1142686|NCT00454649|O3|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
1142687|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
1142688|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
1142689|NCT00454649|O9|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
1142690|NCT00454649|O8|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
1142999|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
1142691|NCT00454649|O7|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
1142692|NCT00454649|O6|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
1142693|NCT00454649|O5|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
1142694|NCT00454649|O4|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
1142695|NCT00454649|O3|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
1142830|NCT00454363|P2|Participant Flow|Pazopanib + pNET|Pancreatic Neuroendocrine (pNET) tumor type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
1142696|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
1142697|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
1142698|NCT00454649|O9|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|AG-013736 oral tablet of 5 mg administered BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (cycle length 21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval between two cycles. Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 administered as infusion on Day 1 Cycle 1 and all subsequent cycles.
1142699|NCT00454649|O8|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|AG-013736 oral tablet of 5 mg administered BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (cycle length 21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval. Cisplatin 80 mg/m^2 administered as infusion on Day 1 of Cycle 1 and all subsequent cycles. Gemcitabine 1250 mg/m^2 administered as infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles.
1142700|NCT00454649|O7|Outcome|Axitinib + Capecitabine (Cohort 7)|AG-013736 oral tablet of 5 mg administered BID from Day 1 to Day 18 of Cycle 1 (cycle length 21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval between two cycles. Capecitabine (1250 mg/m^2) administered orally BID from Day 1 to Day 14 of every cycle.
1142701|NCT00454649|O6|Outcome|Axitinib + Capecitabine (Cohort 6)|AG-013736 oral tablet of 5 mg administered BID from Day 1 to Day 18 of Cycle 1 (cycle length 21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval between two cycles. Capecitabine (1000 mg/m^2) administered orally BID from Day 1 to Day 14 of every cycle.
1142702|NCT00454649|O5|Outcome|Axitinib + Docetaxel (Cohort 5)|AG-013736 oral tablet of 5 mg administered BID as lead in dose from Day -5, -4 or -3 to Day 2 of Cycle 1. AG-013736 standard dose of 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (cycle length 21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval between two cycles. Docetaxel 100 mg/m^2 administered as 60-minute infusion on Day 1 of every cycle.
1142703|NCT00454649|O4|Outcome|Axitinib + Paclitaxel (Cohort 4)|AG-013736 oral tablet of 5 mg administered BID from Day 1 to Day 25 of Cycle 1 (cycle length 28 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval between two cycles. Paclitaxel 90 mg/m^2 administered as 60-minute infusion on Day 1, 8, and 15 of every cycle.
1142704|NCT00454649|O3|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|AG-013736 oral tablet of 5 mg administered BID as lead in dose from Day -5, -4 or -3 to Day 2 of Cycle 1 (cycle length 21 days). AG-013736 standard dose of 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 and all subsequent cycles with no interval between two cycles. Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin at a dose to target AUC of 6.0 mg*min/mL as 30-minute infusion administered once weekly from Day 1 of Cycle 1 and all subsequent cycles.
1142705|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|AG-013736 3 oral tablets of 1 mg administered BID as lead in dose from Day -5, -4 or -3 to Day 2 of Cycle 1 (cycle length 21 days). AG-013736 standard dose of 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 and all subsequent cycles with no interval between two cycles. Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin at a dose to target AUC of 6.0 mg*min/mL as 30-minute infusion administered once weekly from Day 1 of Cycle 1 and all subsequent cycles.
1142706|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) oral tablet of 1 mg (milligram) administered twice daily (BID) as lead in dose from Day -5, -4 or -3 to Day 2 of Cycle 1 (cycle length 21 days). AG-013736 standard dose of 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 and all subsequent cycles with no interval between two cycles. Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) as 30-minute infusion administered once weekly from Day 1 of Cycle 1 and all subsequent cycles.
1143000|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
1142707|NCT00454649|O9|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
1142708|NCT00454649|O8|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
1142709|NCT00454649|O7|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
1142710|NCT00454649|O6|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
1142711|NCT00454649|O5|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
1142712|NCT00454649|O4|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
1142713|NCT00454649|O3|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
1142714|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
1142715|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
1142716|NCT00454649|E10|Reported Event|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
1142717|NCT00454649|E9|Reported Event|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
1142718|NCT00454649|E8|Reported Event|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
1142719|NCT00454649|E7|Reported Event|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
1142720|NCT00454649|E6|Reported Event|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
1142721|NCT00454649|E5|Reported Event|Axitinib + Docetaxel + Carboplatin (Cohort 4a)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Docetaxel (75 mg/m^2) 60-minute infusion on Day 1 of every cycle. Carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
1142722|NCT00454649|E4|Reported Event|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
1142723|NCT00454649|E3|Reported Event|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
1142748|NCT00454636|O3|Outcome|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
1143520|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1142724|NCT00454649|E2|Reported Event|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
1142725|NCT00454649|E1|Reported Event|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
1142726|NCT00454636|B5|Baseline|Total|Total of all reporting groups
1142727|NCT00454636|B4|Baseline|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
1142728|NCT00454636|B3|Baseline|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
1142729|NCT00454636|B2|Baseline|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
1142730|NCT00454636|B1|Baseline|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
1142731|NCT00454636|P4|Participant Flow|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
1142732|NCT00454636|P3|Participant Flow|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
1142733|NCT00454636|P2|Participant Flow|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
1142734|NCT00454636|P1|Participant Flow|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
1142735|NCT00454636|O4|Outcome|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
1142736|NCT00454636|O3|Outcome|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
1142737|NCT00454636|O2|Outcome|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
1142738|NCT00454636|O1|Outcome|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
1142739|NCT00454636|O4|Outcome|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
1142740|NCT00454636|O3|Outcome|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
1142741|NCT00454636|O2|Outcome|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
1142742|NCT00454636|O1|Outcome|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
1142743|NCT00454636|O4|Outcome|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
1142744|NCT00454636|O3|Outcome|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
1142745|NCT00454636|O2|Outcome|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
1142746|NCT00454636|O1|Outcome|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
1142747|NCT00454636|O4|Outcome|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
1142994|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
1142749|NCT00454636|O2|Outcome|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
1142750|NCT00454636|O1|Outcome|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
1142751|NCT00454636|O4|Outcome|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
1142752|NCT00454636|O3|Outcome|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
1142753|NCT00454636|O2|Outcome|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
1142754|NCT00454636|O1|Outcome|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
1144340|NCT00449540|P2|Participant Flow|Active TMS|Active Transcranial Magnetic Stimulation Device
1142755|NCT00454636|O4|Outcome|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
1142756|NCT00454636|O3|Outcome|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
1142757|NCT00454636|O2|Outcome|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
1142758|NCT00454636|O1|Outcome|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
1142759|NCT00454636|E4|Reported Event|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
1142760|NCT00454636|E3|Reported Event|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
1142761|NCT00454636|E2|Reported Event|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
1142762|NCT00454636|E1|Reported Event|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
1142763|NCT00454584|B4|Baseline|Total|Total of all reporting groups
1142764|NCT00454584|B3|Baseline|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
1142765|NCT00454584|B2|Baseline|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 45 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 45 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
1142766|NCT00454584|B1|Baseline|Group I: Etanercept|Participants received Etanercept 50 mg twice weekly through Week 12. Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16 and 20. Participants with PGA leeser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
1142767|NCT00454584|P6|Participant Flow|Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-64) – receiving ustekinumab 90 mg at Weeks 0 -> retreated with ustekinumab 90 mg if becoming a nonresponder during Week 12 and Week 40.
1142768|NCT00454584|P5|Participant Flow|Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-64) – receiving ustekinumab 45 mg at Weeks 0 -> retreated with ustekinumab 45 mg if becoming a nonresponder during Week 12 and Week 40.
1142769|NCT00454584|P4|Participant Flow|Etanercept (After CP)|After Controlled period (Week 12- 64) – receiving etanercept at Weeks 0 -> receiving ustekinumab 90 mg if becoming a nonresponder during Week 12 and Week 40
1142770|NCT00454584|P3|Participant Flow|Ustekinumab 90 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 90 mg group
1142771|NCT00454584|P2|Participant Flow|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg group
1142772|NCT00454584|P1|Participant Flow|Etanercept (CP)|Controlled period (Week 0-12) - Etanercept group
1142773|NCT00454584|O2|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
1142774|NCT00454584|O1|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 45 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 45 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
1142995|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
1147572|NCT00441545|O1|Outcome|Fosrenol|Lanthanum carbonate
1142775|NCT00454584|O3|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
1142776|NCT00454584|O2|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 45 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 45 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
1142777|NCT00454584|O1|Outcome|Group I: Etanercept|Participants received Etanercept 50 mg twice weekly through Week 12. Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16 and 20. Participants with PGA leeser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
1142778|NCT00454584|O3|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
1142831|NCT00454363|P1|Participant Flow|Pazopanib + Carcinoid|Carcinoid Tumor Type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
1142779|NCT00454584|O2|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 45 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 45 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
1142780|NCT00454584|O1|Outcome|Group I: Etanercept|Participants received Etanercept 50 mg twice weekly through Week 12. Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16 and 20. Participants with PGA leeser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
1142781|NCT00454584|O3|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
1142782|NCT00454584|O2|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 45 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 45 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
1142783|NCT00454584|O1|Outcome|Group I: Etanercept|Participants received Etanercept 50 mg twice weekly through Week 12. Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16 and 20. Participants with PGA leeser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
1142784|NCT00454584|E7|Reported Event|Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-64) – receiving ustekinumab 90 mg at Weeks 0 -> retreated with ustekinumab 90 mg if becoming a nonresponder during Week 12 and Week 40.
1142785|NCT00454584|E6|Reported Event|Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-64) – receiving ustekinumab 45 mg at Weeks 0 -> retreated with ustekinumab 45 mg if becoming a nonresponder during Week 12 and Week 40.
1142786|NCT00454584|E5|Reported Event|Etanercept -> Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-64) – receiving etanercept at Weeks 0 -> receiving ustekinumab 90 mg upon becoming a nonresponder during Week 12 and Week 40. This group is a subpopulation of Etanercept (after CP).
1142787|NCT00454584|E4|Reported Event|Etanercept (After CP)|After Controlled period (Week 12-64) – receiving etanercept at Weeks 0 -> prior to being treated with ustekinumab
1142788|NCT00454584|E3|Reported Event|Ustekinumab 90 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 90 mg group
1142789|NCT00454584|E2|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg group
1142790|NCT00454584|E1|Reported Event|Etanercept (CP)|Controlled period (Week 0-12) - Etanercept group
1142791|NCT00454571|B3|Baseline|Total|Total of all reporting groups
1142792|NCT00454571|B2|Baseline|Leuprolide Acetate and Goserelin Acetate Only|"Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.~leuprolide acetate~goserelin acetate"
1142793|NCT00454571|B1|Baseline|Pazopanib, Leuprolide Acetate, and Goserelin Acetate|"Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~leuprolide acetate~goserelin acetate"
1142794|NCT00454571|P2|Participant Flow|Leuprolide Acetate and Goserelin Acetate Only|"Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.~leuprolide acetate~goserelin acetate"
1142795|NCT00454571|P1|Participant Flow|Pazopanib, Leuprolide Acetate, and Goserelin Acetate|"Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~leuprolide acetate~goserelin acetate"
1142796|NCT00454571|O2|Outcome|Leuprolide Acetate and Goserelin Acetate Only|"Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.~leuprolide acetate~goserelin acetate"
1142797|NCT00454571|O1|Outcome|Pazopanib, Leuprolide Acetate, and Goserelin Acetate|"Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~leuprolide acetate~goserelin acetate"
1142798|NCT00454571|O2|Outcome|Leuprolide Acetate and Goserelin Acetate Only|"Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.~leuprolide acetate~goserelin acetate"
1142799|NCT00454571|O1|Outcome|Pazopanib, Leuprolide Acetate, and Goserelin Acetate|"Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~leuprolide acetate~goserelin acetate"
1142800|NCT00454571|E2|Reported Event|Leuprolide Acetate and Goserelin Acetate Only|"Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.~leuprolide acetate~goserelin acetate"
1142801|NCT00454571|E1|Reported Event|Pazopanib, Leuprolide Acetate, and Goserelin Acetate|"Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~leuprolide acetate~goserelin acetate"
1142802|NCT00454532|B5|Baseline|Total|Total of all reporting groups
1142803|NCT00454532|B4|Baseline|Level 4|40g/day
1142804|NCT00454532|B3|Baseline|Level 3|30g/day
1142805|NCT00454532|B2|Baseline|Level 2|20g/day
1142806|NCT00454532|B1|Baseline|Level 1|10g/day
1142807|NCT00454532|P4|Participant Flow|Level 4|40g/day
1142808|NCT00454532|P3|Participant Flow|Level 3|30g/day
1142809|NCT00454532|P2|Participant Flow|Level 2|20g/day
1142810|NCT00454532|P1|Participant Flow|Level 1|10g/day
1142811|NCT00454532|O4|Outcome|Level 4|40g/day
1142812|NCT00454532|O3|Outcome|Level 3|30g/day
1142813|NCT00454532|O2|Outcome|Level 2|20g/day
1142814|NCT00454532|O1|Outcome|Level 1|10g/day
1142815|NCT00454532|O4|Outcome|Level 4|40g/day
1142816|NCT00454532|O3|Outcome|Level 3|30g/day
1142834|NCT00454363|O2|Outcome|Pazopanib + pNET|Pancreatic Neuroendocrine (pNET) tumor type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
1142835|NCT00454363|O1|Outcome|Pazopanib + Carcinoid|Carcinoid Tumor Type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
1142836|NCT00454363|E1|Reported Event|Pazopanib|Oral pazopanib hydrochloride once daily on days 1-28.
1142837|NCT00454324|B3|Baseline|Total|Total of all reporting groups
1142838|NCT00454324|B2|Baseline|Arm B|"Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
1142839|NCT00454324|B1|Baseline|Arm A|"Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
1142840|NCT00454324|P2|Participant Flow|Arm B|"Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
1142841|NCT00454324|P1|Participant Flow|Arm A|"Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of Area Under the Curve (AUC)=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
1142842|NCT00454324|O2|Outcome|Arm B|"Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
1142843|NCT00454324|O1|Outcome|Arm A|"Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
1142844|NCT00454324|O2|Outcome|Arm B|"Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
1142845|NCT00454324|O1|Outcome|Arm A|"Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
1142846|NCT00454324|O2|Outcome|Arm B|"Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
1142996|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
1142847|NCT00454324|O1|Outcome|Arm A|"Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
1142848|NCT00454324|O2|Outcome|Arm B|"Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
1142849|NCT00454324|O1|Outcome|Arm A|"Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
1142850|NCT00454324|E2|Reported Event|Arm B|"Carboplatin + Abraxane (80mg/m2)given on Days 1, 8 and 15 of a 21 Day Cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
1142851|NCT00454324|E1|Reported Event|Arm A|"Carboplatin + Abraxane (240mg/m2) on Day 1 of a 21 Day cycle, up to 6 cycles~Carboplatin: Carboplatin will be given at a dose of AUC=6, on Day 1 of a 21 Day Cycle~Abraxane: Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)~Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)"
1142852|NCT00454246|B4|Baseline|Total|Total of all reporting groups
1142853|NCT00454246|B3|Baseline|Darbepoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
1142854|NCT00454246|B2|Baseline|Epoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
1142855|NCT00454246|B1|Baseline|Methoxy Polyethylene Glycol-epoetin Beta|"120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
1142856|NCT00454246|P3|Participant Flow|Darbepoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
1142857|NCT00454246|P2|Participant Flow|Epoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
1142858|NCT00454246|P1|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta|"120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
1142859|NCT00454246|O3|Outcome|Darbepoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
1142860|NCT00454246|O2|Outcome|Epoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
1142861|NCT00454246|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|"120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
1142862|NCT00454246|O3|Outcome|Darbepoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
1142863|NCT00454246|O2|Outcome|Epoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
1142864|NCT00454246|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|"120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
1142865|NCT00454246|O3|Outcome|Darbepoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
1148346|NCT00440180|O2|Outcome|Anastrozole|1 milligram daily
1142866|NCT00454246|O2|Outcome|Epoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
1142867|NCT00454246|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|"120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
1142868|NCT00454246|E3|Reported Event|Darbepoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
1142869|NCT00454246|E2|Reported Event|Epoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
1142870|NCT00454246|E1|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta|"120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
1142871|NCT00454207|B3|Baseline|Total|Total of all reporting groups
1142872|NCT00454207|B2|Baseline|Sildenafil: Participants Who Entered the Study From Part II|Consists of participants who newly entered the study from Part II period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to subjects after approval for the indication of pulmonary arterial hypertension).
1142873|NCT00454207|B1|Baseline|Sildenafil: Participant Who Entered the Study From Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142926|NCT00454194|O2|Outcome|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
1143540|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1142874|NCT00454207|P2|Participant Flow|Sildenafil: Participants Who Entered the Study From Part II|Consists of participants who newly entered the study from Part II period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to subjects after approval for the indication of pulmonary arterial hypertension).
1142875|NCT00454207|P1|Participant Flow|Sildenafil: Participant Who Entered the Study From Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142876|NCT00454207|O1|Outcome|Sildenafil: Part I and Part II|Consists of participants who entered the study from Part I period plus participants who entered the study from Part II period.
1142877|NCT00454207|O1|Outcome|Sildenafil:Pharmacokinetic Analysis Participant|Consists of participants who received sildenafil monotherapy, without administration of other treatment drugs for pulmonary arterial hypertension, in Part I or II, and satisfied the inclusion criteria for pharmacokinetics evaluation without violating the exclusion criteria. The participants were treated with sildenafil 20 mg three times a day orally in Part I period(12 weeks) and Part II period (longterm treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142878|NCT00454207|O1|Outcome|Sildenafil:Pharmacokinetic Analysis Participant|Consists of participants who received sildenafil monotherapy, without administration of other treatment drugs for pulmonary arterial hypertension, in Part I or II, and satisfied the inclusion criteria for pharmacokinetics evaluation without violating the exclusion criteria. The participants were treated with sildenafil 20 mg three times a day orally in Part I period(12 weeks) and Part II period (longterm treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142879|NCT00454207|O1|Outcome|Sildenafil:Pharmacokinetic Analysis Participant|Consists of participants who received sildenafil monotherapy, without administration of other treatment drugs for pulmonary arterial hypertension, in Part I or II, and satisfied the inclusion criteria for pharmacokinetics evaluation without violating the exclusion criteria. The participants were treated with sildenafil 20 mg three times a day orally in Part I period(12 weeks) and Part II period (longterm treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142880|NCT00454207|O1|Outcome|Sildenafil:Pharmacokinetic Analysis Participant|Consists of participants who received sildenafil monotherapy, without administration of other treatment drugs for pulmonary arterial hypertension, in Part I or II, and satisfied the inclusion criteria for pharmacokinetics evaluation without violating the exclusion criteria. The participants were treated with sildenafil 20 mg three times a day orally in Part I period(12 weeks) and Part II period (longterm treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142881|NCT00454207|O1|Outcome|Sildenafil:Pharmacokinetic Analysis Participant|Consists of participants who received sildenafil monotherapy, without administration of other treatment drugs for pulmonary arterial hypertension, in Part I or II, and satisfied the inclusion criteria for pharmacokinetics evaluation without violating the exclusion criteria. The participants were treated with sildenafil 20 mg three times a day orally in Part I period(12 weeks) and Part II period (longterm treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142997|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
1142882|NCT00454207|O1|Outcome|Sildenafil:Part II|Consists of participants who newly entered the study from Part II period in Week 0 and had been receiving sildenafil at doses higher than 60 mg/day before the start of this study.The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142883|NCT00454207|O1|Outcome|Sildenafil: Part II|Consists of participants who newly entered the study from Part II period in Week 0 and had been receiving sildenafil at doses higher than 60 mg/day before the start of this study.The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142884|NCT00454207|O4|Outcome|Sildenafil: Part II, Functional Class at Baseline: IV|Consists of participants who newly entered the study from Part II period in Week 0, and whose WHO functional class at baseline were IV. The participants had been receiving sildenafil at doses higher than 60 mg/day before the start of this study.The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142885|NCT00454207|O3|Outcome|Sildenafil: Part II, Functional Class at Baseline: III|Consists of participants who newly entered the study from Part II period in Week 0, and whose WHO functional class at baseline were III. The participants had been receiving sildenafil at doses higher than 60 mg/day before the start of this study.The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142886|NCT00454207|O2|Outcome|Sildenafil:Part II, Functional Class at Baseline: II|Consists of participants who newly entered the study from Part II period in Week 0, and whose who functional class at baseline were II. The participants had been receiving sildenafil at doses higher than 60 mg/day before the start of this study.The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142927|NCT00454194|O1|Outcome|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
1149020|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
1142887|NCT00454207|O1|Outcome|Sildenafil:Part II, Functional Class at Baseline: I|Consists of participants who newly entered the study from Part II period in Week 0, and whose WHO functional class at baseline were I. The participants had been receiving sildenafil at doses higher than 60 mg/day before the start of this study.The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142888|NCT00454207|O1|Outcome|Sildenafil:Part II|Consists of participants who newly entered the study from Part II period in Week 0 and had been receiving sildenafil at doses higher than 60 mg/day before the start of this study. The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142889|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142890|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142891|NCT00454207|O4|Outcome|Sildenafil, Part I, Functional Class at Baseline:IV|Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142892|NCT00454207|O3|Outcome|Sildenafil, Part I, Functional Class at Baseline: III|Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142893|NCT00454207|O2|Outcome|Sildenafil:Part I, Functional Class at Baseline: II|Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142894|NCT00454207|O1|Outcome|Sildenafil:Part I , Functional Class at Baseline: I|Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were I. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142895|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142896|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142897|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142898|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142899|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142900|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142901|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142902|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142928|NCT00454194|O2|Outcome|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
1142903|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142904|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142905|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142906|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142907|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142908|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142909|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142910|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142911|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142912|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142913|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142998|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
1143521|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1142914|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142915|NCT00454207|O1|Outcome|Sildenafil: Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
1142916|NCT00454207|E1|Reported Event|Sildenafil: Part I and Part II|Consists of participants who entered the study from Part I period plus participants who entered the study from Part II period.
1142917|NCT00454194|B3|Baseline|Total|Total of all reporting groups
1142918|NCT00454194|B2|Baseline|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
1142919|NCT00454194|B1|Baseline|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
1142920|NCT00454194|P2|Participant Flow|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
1142921|NCT00454194|P1|Participant Flow|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
1142922|NCT00454194|O2|Outcome|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
1142923|NCT00454194|O1|Outcome|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
1142924|NCT00454194|O2|Outcome|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
1142925|NCT00454194|O1|Outcome|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
1145601|NCT00445679|B3|Baseline|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
1142929|NCT00454194|O1|Outcome|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
1142930|NCT00454194|O2|Outcome|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
1142931|NCT00454194|O1|Outcome|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
1142932|NCT00454194|O2|Outcome|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
1142933|NCT00454194|O1|Outcome|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
1142934|NCT00454194|E2|Reported Event|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
1142935|NCT00454194|E1|Reported Event|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
1142936|NCT00454181|B3|Baseline|Total|Total of all reporting groups
1142937|NCT00454181|B2|Baseline|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
1142938|NCT00454181|B1|Baseline|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
1142939|NCT00454181|P2|Participant Flow|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
1142940|NCT00454181|P1|Participant Flow|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
1142941|NCT00454181|O2|Outcome|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
1142942|NCT00454181|O1|Outcome|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
1142943|NCT00454181|O2|Outcome|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
1142944|NCT00454181|O1|Outcome|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
1142945|NCT00454181|O2|Outcome|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
1142946|NCT00454181|O1|Outcome|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
1142947|NCT00454181|O2|Outcome|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
1142948|NCT00454181|O1|Outcome|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
1142949|NCT00454181|O2|Outcome|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
1142950|NCT00454181|O1|Outcome|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
1142951|NCT00454181|O2|Outcome|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
1142952|NCT00454181|O1|Outcome|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
1142953|NCT00454181|E2|Reported Event|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
1142954|NCT00454181|E1|Reported Event|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
1142955|NCT00454142|B1|Baseline|Treatment (Tyrosine Kinase Inhibitor)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~computed tomography : Correlative studies~pharmacological study : Correlative studies~pazopanib hydrochloride : Given PO"
1142956|NCT00454142|P1|Participant Flow|Treatment (Tyrosine Kinase Inhibitor)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~computed tomography : Correlative studies~pharmacological study : Correlative studies~pazopanib hydrochloride : Given PO"
1142957|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~pharmacological study: Correlative studies~computed tomography: Correlative studies"
1148347|NCT00440180|O1|Outcome|Placebo|Placebo once daily
1142958|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~pharmacological study: Correlative studies~computed tomography: Correlative studies"
1142959|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~pharmacological study: Correlative studies~computed tomography: Correlative studies"
1142960|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~pharmacological study: Correlative studies~computed tomography: Correlative studies"
1142961|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~pharmacological study: Correlative studies~computed tomography: Correlative studies"
1142962|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~pharmacological study: Correlative studies~computed tomography: Correlative studies"
1142963|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~pharmacological study: Correlative studies~computed tomography: Correlative studies"
1142964|NCT00454142|O1|Outcome|Treatment (Tyrosine Kinase Inhibitor)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~computed tomography : Correlative studies~pharmacological study : Correlative studies~pazopanib hydrochloride : Given PO"
1142965|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~pharmacological study: Correlative studies~computed tomography: Correlative studies"
1143303|NCT00453063|B1|Baseline|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
1142966|NCT00454142|O1|Outcome|Treatment (Tyrosine Kinase Inhibitor)|"Patients receive pazopanib hydrochloride PO daily (QD) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~computed tomography : Correlative studies~pharmacological study : Correlative studies~pazopanib hydrochloride : Given PO"
1142967|NCT00454142|O1|Outcome|Treatment (Tyrosine Kinase Inhibitor)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~computed tomography : Correlative studies~pharmacological study : Correlative studies~pazopanib hydrochloride : Given PO"
1142968|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~pharmacological study: Correlative studies~computed tomography: Correlative studies"
1142969|NCT00454142|E1|Reported Event|Treatment (Tyrosine Kinase Inhibitor)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~computed tomography : Correlative studies~pharmacological study : Correlative studies~pazopanib hydrochloride : Given PO"
1142970|NCT00454116|B4|Baseline|Total|Total of all reporting groups
1142971|NCT00454116|B3|Baseline|Placebo Plus FOLFIRI|placebo plus FOLFIRI
1142972|NCT00454116|B2|Baseline|Vandetanib 300 mg Plus FOLFIRI|vandetanib 300 mg plus FOLFIRI
1142973|NCT00454116|B1|Baseline|Vandetanib 100 mg Plus FOLFIRI|vandetanib 100 mg plus FOLFIRI
1142974|NCT00454116|P3|Participant Flow|Placebo Plus FOLFIRI|placebo plus FOLFIRI
1142975|NCT00454116|P2|Participant Flow|Vandetanib 300 mg Plus FOLFIRI|vandetanib 300 mg plus FOLFIRI
1142976|NCT00454116|P1|Participant Flow|Vandetanib 100 mg Plus FOLFIRI|vandetanib 100 mg plus FOLFIRI
1142977|NCT00454116|O3|Outcome|Placebo Plus FOLFIRI|placebo plus FOLFIRI
1142978|NCT00454116|O2|Outcome|Vandetanib 300 mg Plus FOLFIRI|vandetanib 300 mg plus FOLFIRI
1142979|NCT00454116|O1|Outcome|Vandetanib 100 mg Plus FOLFIRI|vandetanib 100 mg plus FOLFIRI
1142980|NCT00454116|E3|Reported Event|Placebo Plus FOLFIRI|placebo plus FOLFIRI
1142981|NCT00454116|E2|Reported Event|Vandetanib 300 mg Plus FOLFIRI|vandetanib 300 mg plus FOLFIRI
1142982|NCT00454116|E1|Reported Event|Vandetanib 100 mg Plus FOLFIRI|vandetanib 100 mg plus FOLFIRI
1142983|NCT00454051|B3|Baseline|Total|Total of all reporting groups
1142984|NCT00454051|B2|Baseline|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
1142985|NCT00454051|B1|Baseline|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
1142986|NCT00454051|P2|Participant Flow|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
1142987|NCT00454051|P1|Participant Flow|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
1142988|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
1142989|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
1142990|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
1142991|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
1142992|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
1142993|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
1143001|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
1143002|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
1143003|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
1143004|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
1143005|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
1143006|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
1143007|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
1143008|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
1143009|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
1143010|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
1143011|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
1143012|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
1143013|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
1143014|NCT00454051|E2|Reported Event|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
1149021|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
1143015|NCT00454051|E1|Reported Event|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
1143016|NCT00453999|B4|Baseline|Total|Total of all reporting groups
1143017|NCT00453999|B3|Baseline|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
1143018|NCT00453999|B2|Baseline|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
1143019|NCT00453999|B1|Baseline|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
1143020|NCT00453999|P3|Participant Flow|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
1143021|NCT00453999|P2|Participant Flow|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
1143022|NCT00453999|P1|Participant Flow|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
1143023|NCT00453999|O3|Outcome|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
1143024|NCT00453999|O2|Outcome|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
1143025|NCT00453999|O1|Outcome|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
1143026|NCT00453999|O3|Outcome|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
1143027|NCT00453999|O2|Outcome|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
1143028|NCT00453999|O1|Outcome|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
1143029|NCT00453999|O3|Outcome|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
1143030|NCT00453999|O2|Outcome|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
1143031|NCT00453999|O1|Outcome|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
1143032|NCT00453999|O3|Outcome|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
1143033|NCT00453999|O2|Outcome|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
1143034|NCT00453999|O1|Outcome|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
1143035|NCT00453999|O3|Outcome|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
1143036|NCT00453999|O2|Outcome|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
1143037|NCT00453999|O1|Outcome|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
1143038|NCT00453999|O3|Outcome|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
1143039|NCT00453999|O2|Outcome|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution ) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
1143040|NCT00453999|O1|Outcome|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
1143041|NCT00453999|E3|Reported Event|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
1143042|NCT00453999|E2|Reported Event|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
1143043|NCT00453999|E1|Reported Event|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
1143044|NCT00453986|B6|Baseline|Total|Total of all reporting groups
1143045|NCT00453986|B5|Baseline|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
1143046|NCT00453986|B4|Baseline|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
1143047|NCT00453986|B3|Baseline|Nimenrix C Group|subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143048|NCT00453986|B2|Baseline|Nimenrix B Group|subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143049|NCT00453986|B1|Baseline|Nimenrix A Group|subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143050|NCT00453986|P5|Participant Flow|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
1149022|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
1143051|NCT00453986|P4|Participant Flow|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
1143052|NCT00453986|P3|Participant Flow|Nimenrix C Group|subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143053|NCT00453986|P2|Participant Flow|Nimenrix B Group|subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143054|NCT00453986|P1|Participant Flow|Nimenrix A Group|subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143055|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
1143056|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Group Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143057|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
1143058|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
1143059|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143060|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
1143061|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
1143062|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143063|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
1143064|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143065|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
1143066|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143067|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
1143068|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
1143936|NCT00451282|O1|Outcome|Intervention|Injured children receiving Stepped Preventive Care intervention
1143069|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143070|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
1143071|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
1143072|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143073|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
1143074|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
1143075|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143076|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
1143077|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143078|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
1143079|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143080|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
1143081|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143082|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
1143083|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
1143084|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143085|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
1143086|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
1143087|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143088|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
1143089|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
1143090|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143091|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
1143092|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143093|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
1143094|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
1143095|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143096|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
1143097|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
1143098|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143099|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
1143100|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143101|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
1143102|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143103|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
1143104|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
1143105|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143106|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
1143107|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
1143108|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143109|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
1143110|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143111|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
1143112|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143113|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
1143114|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
1143115|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143116|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
1143117|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143118|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
1143119|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143120|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
1143121|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
1143122|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143522|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143123|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
1143124|NCT00453986|O3|Outcome|Nimenrix C Group|subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143125|NCT00453986|O2|Outcome|Nimenrix B Group|subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143126|NCT00453986|O1|Outcome|Nimenrix A Group|subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143127|NCT00453986|O3|Outcome|Nimenrix C Group|subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143128|NCT00453986|O2|Outcome|Nimenrix B Group|subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143129|NCT00453986|O1|Outcome|Nimenrix A Group|subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143130|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
1143131|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
1143132|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
1143133|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
1143134|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143135|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
1143136|NCT00453986|O2|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of Fluarix vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143137|NCT00453986|O1|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
1143138|NCT00453986|O3|Outcome|Nimenrix C Group|subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143139|NCT00453986|O2|Outcome|Nimenrix B Group|subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143140|NCT00453986|O1|Outcome|Nimenrix A Group|subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143141|NCT00453986|E5|Reported Event|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
1143142|NCT00453986|E4|Reported Event|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143143|NCT00453986|E3|Reported Event|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
1143144|NCT00453986|E2|Reported Event|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
1143145|NCT00453986|E1|Reported Event|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
1143146|NCT00453973|B3|Baseline|Pooled AF37702 Inj.|
1143147|NCT00453973|B2|Baseline|Treatment Initiation in Non-Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were not on dialysis and not on erythropoiesis stimulating agents (ESAs), and who received peginesatide (NCT00228436). The median first dose at study start was 0.024 mg/kg with an interquartile range of 0.017 to 0.035 mg/kg. This group is categorized as Initiation of Treatment in Non-Dialysis Participants regardless of dialysis status at the start of or during this study."
1143204|NCT00453362|O1|Outcome|Erlotinib|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi."
1143148|NCT00453973|B1|Baseline|Maintenance Switch in Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were on dialysis and had been on Epoetin at study entry, and who were switched to peginesatide (NCT00434330). The median first dose at study start was 0.044 milligram per kilogram (mg/kg) with an interquartile range of 0.028 to 0.076 mg/kg. This group is categorized as Maintenance Switch in Dialysis Participants regardless of dialysis status at the start of or during this study."
1143149|NCT00453973|P2|Participant Flow|Treatment Initiation in Non-Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were not on dialysis and not on erythropoiesis stimulating agents (ESAs), and who received peginesatide (NCT00228436). The median first dose at study start was 0.024 mg/kg with an interquartile range of 0.017 to 0.035 mg/kg. This group is categorized as Initiation of Treatment in Non-Dialysis Participants regardless of dialysis status at the start of or during this study."
1143150|NCT00453973|P1|Participant Flow|Maintenance Switch in Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were on dialysis and had been on Epoetin at study entry, and who were switched to peginesatide (NCT00434330). The median first dose at study start was 0.044 milligram per kilogram (mg/kg) with an interquartile range of 0.028 to 0.076 mg/kg. This group is categorized as Maintenance Switch in Dialysis Participants regardless of dialysis status at the start of or during this study."
1143151|NCT00453973|O2|Outcome|Treatment Initiation in Non-Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were not on dialysis and not on erythropoiesis stimulating agents (ESAs), and who received peginesatide (NCT00228436). The median first dose at study start was 0.024 mg/kg with an interquartile range of 0.017 to 0.035 mg/kg. This group is categorized as Initiation of Treatment in Non-Dialysis Participants regardless of dialysis status at the start of or during this study."
1143242|NCT00453310|B1|Baseline|Sunitinib Malate|"The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks)~sunitinib malate"
1149023|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
1143152|NCT00453973|O1|Outcome|Maintenance Switch in Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were on dialysis and had been on Epoetin at study entry, and who were switched to peginesatide (NCT00434330). The median first dose at study start was 0.044 milligram per kilogram (mg/kg) with an interquartile range of 0.028 to 0.076 mg/kg. This group is categorized as Maintenance Switch in Dialysis Participants regardless of dialysis status at the start of or during this study."
1143153|NCT00453973|E2|Reported Event|Treatment Initiation in Non-Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were not on dialysis and not on erythropoiesis stimulating agents (ESAs), and who received peginesatide (NCT00228436). The median first dose at study start was 0.024 mg/kg with an interquartile range of 0.017 to 0.035 mg/kg. This group is categorized as Initiation of Treatment in Non-Dialysis Participants regardless of dialysis status at the start of or during this study."
1143154|NCT00453973|E1|Reported Event|Maintenance Switch in Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were on dialysis and had been on Epoetin at study entry, and who were switched to peginesatide (NCT00434330). The median first dose at study start was 0.044 milligram per kilogram (mg/kg) with an interquartile range of 0.028 to 0.076 mg/kg. This group is categorized as Maintenance Switch in Dialysis Participants regardless of dialysis status at the start of or during this study."
1143155|NCT00453388|B5|Baseline|Total|Total of all reporting groups
1143156|NCT00453388|B4|Baseline|Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
1143157|NCT00453388|B3|Baseline|Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with history of hematologic malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
1143158|NCT00453388|B2|Baseline|Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-haploidentical donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
1143159|NCT00453388|B1|Baseline|Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with a history of hematologic malignancy and HLA-haploidentical donor receive fludarabine phosphate (FLU) intravenously (IV) over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF orally (PO) thrice daily (TID) on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
1143263|NCT00453180|O2|Outcome|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.~Placebo: Subjects randomized to placebo arm will receive placebo pill for duration of study."
1143160|NCT00453388|P4|Participant Flow|Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
1143161|NCT00453388|P3|Participant Flow|Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with history of hematologic malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
1143190|NCT00453362|O1|Outcome|Erlotinib_FLT Responders|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who had CR/PR on FLT-PET scans at Day 56 were included in this group."
1149024|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
1143162|NCT00453388|P2|Participant Flow|Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-haploidentical donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
1143163|NCT00453388|P1|Participant Flow|Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with a history of hematologic malignancy and HLA-haploidentical donor receive fludarabine phosphate (FLU) intravenously (IV) over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF orally (PO) thrice daily (TID) on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
1143164|NCT00453388|O4|Outcome|Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
1143165|NCT00453388|O3|Outcome|Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with history of hematologic malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
1143166|NCT00453388|O2|Outcome|Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-haploidentical donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
1143167|NCT00453388|O1|Outcome|Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with a history of hematologic malignancy and HLA-haploidentical donor receive fludarabine phosphate (FLU) intravenously (IV) over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF orally (PO) thrice daily (TID) on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
1143168|NCT00453388|O4|Outcome|Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
1148348|NCT00440180|E2|Reported Event|Anastrozole|1 milligram daily
1143169|NCT00453388|O3|Outcome|Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with history of hematologic malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
1143170|NCT00453388|O2|Outcome|Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-haploidentical donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
1143171|NCT00453388|O1|Outcome|Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with a history of hematologic malignancy and HLA-haploidentical donor receive fludarabine phosphate (FLU) intravenously (IV) over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF orally (PO) thrice daily (TID) on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
1143172|NCT00453388|O4|Outcome|Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
1143173|NCT00453388|O3|Outcome|Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with history of hematologic malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
1143174|NCT00453388|O2|Outcome|Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-haploidentical donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
1143175|NCT00453388|O1|Outcome|Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with a history of hematologic malignancy and HLA-haploidentical donor receive fludarabine phosphate (FLU) intravenously (IV) over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF orally (PO) thrice daily (TID) on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
1143176|NCT00453388|O4|Outcome|Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
1143177|NCT00453388|O3|Outcome|Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with history of hematologic malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
1143523|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143178|NCT00453388|O2|Outcome|Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-haploidentical donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
1143191|NCT00453362|O2|Outcome|Erlotinib_FDG Progressive Disease With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had Progressive disease on FDG-PET scans at Day 56 were included in this group."
1143243|NCT00453310|P1|Participant Flow|Sunitinib Malate|"The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks)~sunitinib malate"
1143179|NCT00453388|O1|Outcome|Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with a history of hematologic malignancy and HLA-haploidentical donor receive fludarabine phosphate (FLU) intravenously (IV) over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF orally (PO) thrice daily (TID) on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
1143180|NCT00453388|E4|Reported Event|Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
1143181|NCT00453388|E3|Reported Event|Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with history of hematologic malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
1143182|NCT00453388|E2|Reported Event|Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)|"Patients with no history of hematological malignancy and HLA-haploidentical donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
1143183|NCT00453388|E1|Reported Event|Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation)|"Patients with a history of hematologic malignancy and HLA-haploidentical donor receive fludarabine phosphate (FLU) intravenously (IV) over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF orally (PO) thrice daily (TID) on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD.~Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant~Cyclophosphamide: Given IV~Cyclosporine: Given IV or PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Total-Body Irradiation: Undergo TBI"
1143184|NCT00453362|B1|Baseline|Erlotinib|Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
1143185|NCT00453362|P1|Participant Flow|Erlotinib|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~After 14 days and after 56 days of treatment with Erlotinib participants underwent FDG-PET (2-deoxy-2-[18F]fluoro-D-glucose-Positron Emission Tomogrpahy)and FLT-PET (3'-deoxy-3'-[18F]fluorothymidine-Positron Emission Tomogrpahy) scans.~FDG-PET intravenous injection dosage was based on participant's weight not to exceed 15 mCi and FLT-PET intravenous dose was 7 mCi."
1143186|NCT00453362|O1|Outcome|Overall Study Participants|"All Participants who underwent any FLT-PET scan during the study (including screening) were included in the analysis.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi."
1143187|NCT00453362|O2|Outcome|Erlotinib_FLT Progressive Disease With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who had Progressive disease on FLT-PET scans at Day 56 were included in this group."
1143188|NCT00453362|O1|Outcome|Erlotinib_FLT Responders With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who had CR/PR on FLT-PET scans at Day 56 were included in this group."
1143361|NCT00452699|B1|Baseline|FSC DISKUS 250/50 mcg BID for 52 Weeks|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
1143937|NCT00451282|O2|Outcome|Usual Care|Injured children receiving usual care
1143189|NCT00453362|O2|Outcome|Erlotinib_ FLT Non-Responders|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who did not have CR/PR on FLT-PET scans at Day 56 were included in this group."
1143244|NCT00453310|O1|Outcome|Sunitinib Malate|"The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks)~sunitinib malate"
1143304|NCT00453063|P2|Participant Flow|Placebo|Two sprays in each nostril once daily
1143192|NCT00453362|O1|Outcome|Erlotinib_FDG Responders With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had CR/PR on FDG-PET scans at Day 56 were included in this group."
1143193|NCT00453362|O1|Outcome|Erlotinib|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi."
1143194|NCT00453362|O1|Outcome|Erlotinib|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight no to exceed 15 mCi."
1143195|NCT00453362|O2|Outcome|Erlotinib_ FDG Non-Responder|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who did not have CR/PR on FDG-PET scans at Day 56 were included in this group."
1143196|NCT00453362|O1|Outcome|Erlotinib_FDG Responders|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had CR/PR on FDG-PET scans at Day 56 were included in this group."
1143197|NCT00453362|O2|Outcome|Erlotinib_FLT Progressive Disease With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who had Progressive disease on FLT-PET scans at Day 56 were included in this group."
1143198|NCT00453362|O1|Outcome|Erlotinib_FLT Responders With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who had CR/PR on FLT-PET scans at Day 56 were included in this group."
1143199|NCT00453362|O2|Outcome|Erlotinib_ FLT Non-Responders|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who did not have CR/PR on FLT-PET scans at Day 56 were included in this group."
1143200|NCT00453362|O1|Outcome|Erlotinib_FLT Responders|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who had CR/PR on FLT-PET scans at Day 56 were included in this group."
1143201|NCT00453362|O1|Outcome|Erlotinib|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi."
1143202|NCT00453362|O2|Outcome|Erlotinib_FDG Progressive Disease With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had Progressive disease on FDG-PET scans at Day 56 were included in this group."
1143203|NCT00453362|O1|Outcome|Erlotinib_FDG Responders With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had CR/PR on FDG-PET scans at Day 56 were included in this group."
1143362|NCT00452699|P2|Participant Flow|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
1143524|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143205|NCT00453362|O2|Outcome|Erlotinib_ FDG Non-Responders|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who did not have CR/PR on FDG-PET scans at Day 56 were included in this group."
1143206|NCT00453362|O1|Outcome|Erlotinib_FDG Responders|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had CR/PR on FDG-PET scans at Day 56 were included in this group."
1143241|NCT00453336|E1|Reported Event|Single Arm|"Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.~Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home."
1143207|NCT00453362|E1|Reported Event|Erlotinib|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~After 14 days and after 56 days of treatment with Erlotinib, participants underwent FDG-PET and FLT-PET scans. FDG-PET intravenous injection-dosage based on participant's weight not to exceed 15 mCi and FLT-PET intravenous dose of 7 mCi."
1143208|NCT00453349|B3|Baseline|Total|Total of all reporting groups
1143209|NCT00453349|B2|Baseline|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
1143210|NCT00453349|B1|Baseline|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
1143211|NCT00453349|P2|Participant Flow|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
1143212|NCT00453349|P1|Participant Flow|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
1143213|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
1143214|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
1143215|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
1143216|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
1143217|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
1143218|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
1143219|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
1143220|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
1143221|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
1143222|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
1143223|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
1143224|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
1143225|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
1143226|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
1143227|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
1143228|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
1143229|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
1143230|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
1143231|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
1143232|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
1143233|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
1143234|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
1143235|NCT00453349|E2|Reported Event|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
1143236|NCT00453349|E1|Reported Event|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
1143237|NCT00453336|B1|Baseline|Single Arm|"Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.~Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home."
1143238|NCT00453336|P1|Participant Flow|Single Arm|"Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.~Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home."
1143363|NCT00452699|P1|Participant Flow|FSC DISKUS 250/50 mcg BID for 52 Weeks|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
1143938|NCT00451282|O1|Outcome|Intervention|Injured children receiving Stepped Preventive Care intervention
1143239|NCT00453336|O1|Outcome|Single Arm|"Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.~Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home."
1143240|NCT00453336|O1|Outcome|Single Arm|"Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.~Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home."
1143245|NCT00453310|E1|Reported Event|Sunitinib Malate|"The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks)~sunitinib malate"
1143246|NCT00453206|B1|Baseline|Reduced Intensity Allogeneic Cell Transplantation|reduced intensisty transplant are those that do not completely eliminate the patient's stem cells prior to recieving the bone marrow transplant
1143247|NCT00453206|P1|Participant Flow|Reduced Intensity Allogeneic Cell Transplantation|reduced intensisty transplant are those that do not completely eliminate the patient's stem cells prior to recieving the bone marrow transplant
1143248|NCT00453206|O1|Outcome|Reduced Intensity Allogeneic Cell Transplantation|reduced intensisty transplant are those that do not completely eliminate the patient's stem cells prior to recieving the bone marrow transplant
1143249|NCT00453206|E1|Reported Event|Reduced Intensity Allogeneic Cell Transplantation|reduced intensisty transplant are those that do not completely eliminate the patient's stem cells prior to recieving the bone marrow transplant
1143250|NCT00453193|B1|Baseline|Alemtuzumab + Pentostatin|Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m^2 IV weekly for 4 weeks then every 2 weeks
1143251|NCT00453193|P1|Participant Flow|Alemtuzumab + Pentostatin|Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m^2 IV weekly for 4 weeks then every 2 weeks
1143252|NCT00453193|O1|Outcome|Alemtuzumab + Pentostatin|Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m^2 IV weekly for 4 weeks then every 2 weeks
1143253|NCT00453193|E1|Reported Event|Alemtuzumab + Pentostatin|Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m^2 IV weekly for 4 weeks then every 2 weeks
1143254|NCT00453180|B3|Baseline|Total|Total of all reporting groups
1143255|NCT00453180|B2|Baseline|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.~Placebo: Subjects randomized to placebo arm will receive placebo pill for duration of study."
1143256|NCT00453180|B1|Baseline|N-acetylcysteine|"Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.~N-acetylcysteine: Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day."
1143257|NCT00453180|P2|Participant Flow|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.~Placebo: Subjects randomized to placebo arm will receive placebo pill for duration of study."
1143258|NCT00453180|P1|Participant Flow|N-acetylcysteine|"Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.~N-acetylcysteine: Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day."
1143259|NCT00453180|O2|Outcome|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.~Placebo: Subjects randomized to placebo arm will receive placebo pill for duration of study."
1143260|NCT00453180|O1|Outcome|N-acetylcysteine|"Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.~N-acetylcysteine: Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day."
1143261|NCT00453180|O2|Outcome|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.~Placebo: Subjects randomized to placebo arm will receive placebo pill for duration of study."
1143262|NCT00453180|O1|Outcome|N-acetylcysteine|"Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.~N-acetylcysteine: Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day."
1148349|NCT00440180|E1|Reported Event|Placebo|Placebo once daily
1143264|NCT00453180|O1|Outcome|N-acetylcysteine|"Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.~N-acetylcysteine: Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day."
1143265|NCT00453180|O2|Outcome|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.~Placebo: Subjects randomized to placebo arm will receive placebo pill for duration of study."
1143266|NCT00453180|O1|Outcome|N-acetylcysteine|"Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.~N-acetylcysteine: Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day."
1143267|NCT00453180|O2|Outcome|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.~Placebo: Subjects randomized to placebo arm will receive placebo pill for duration of study."
1143268|NCT00453180|O1|Outcome|N-acetylcysteine|"Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.~N-acetylcysteine: Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day."
1143301|NCT00453063|B3|Baseline|Total|Total of all reporting groups
1143269|NCT00453180|O2|Outcome|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.~Placebo: Subjects randomized to placebo arm will receive placebo pill for duration of study."
1143270|NCT00453180|O1|Outcome|N-acetylcysteine|"Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.~N-acetylcysteine: Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day."
1143271|NCT00453180|E2|Reported Event|Placebo|"Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain in active ingredients.~Placebo: Subjects randomized to placebo arm will receive placebo pill for duration of study."
1143272|NCT00453180|E1|Reported Event|N-acetylcysteine|"Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.~N-acetylcysteine: Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day."
1143273|NCT00453154|B4|Baseline|Total|Total of all reporting groups
1143274|NCT00453154|B3|Baseline|Arm II (Combination Chemotherapy + Placebo Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m2 by IV over 1 hour on days 1, 2, and 3 every cycle~Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression."
1143275|NCT00453154|B2|Baseline|Arm I (Combination Chemotherapy + Sunitinib Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle~Maintenance: Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
1143276|NCT00453154|B1|Baseline|Phase I|"Participants will receive the following combination chemotherapy for 6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle Sunitinib 25 mg oral, daily days 1-14 every cycle~Maintenance: Following 6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
1143277|NCT00453154|P4|Participant Flow|Double Blind Sunitinib Maintenance|Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression.
1143278|NCT00453154|P3|Participant Flow|Double Blind Placebo Maintenance With Optional Crossover|"Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression.~At progression, participants receiving placebo could cross over to receive open label sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
1143279|NCT00453154|P2|Participant Flow|Phase II Combination Chemotherapy|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m^2 by IVover 1 hour on days 1, 2, and 3 every cycle"
1143280|NCT00453154|P1|Participant Flow|Phase 1B|"Participants will receive the following combination chemotherapy for 6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle Sunitinib 25 mg oral, daily days 1-14 every cycle~Maintenance: Following 6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
1143281|NCT00453154|O2|Outcome|Arm II (Combination Chemotherapy + Placebo Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m2 by IV over 1 hour on days 1, 2, and 3 every cycle~Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression."
1143282|NCT00453154|O1|Outcome|Arm I (Combination Chemotherapy + Sunitinib Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle~Maintenance: Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
1143283|NCT00453154|O2|Outcome|Arm II (Combination Chemotherapy + Placebo Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m2 by IV over 1 hour on days 1, 2, and 3 every cycle~Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression."
1143284|NCT00453154|O1|Outcome|Arm I (Combination Chemotherapy + Sunitinib Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle~Maintenance: Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
1143285|NCT00453154|O2|Outcome|Arm II (Combination Chemotherapy + Placebo Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m2 by IV over 1 hour on days 1, 2, and 3 every cycle~Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression."
1143286|NCT00453154|O1|Outcome|Arm I (Combination Chemotherapy + Sunitinib Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle~Maintenance: Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
1143302|NCT00453063|B2|Baseline|Placebo|Two sprays in each nostril once daily
1143541|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1143287|NCT00453154|O3|Outcome|Cohort 3|"Participants will receive the following combination chemotherapy for 6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle Sunitinib 50 mg oral, daily days 1-14 every cycle~Maintenance: Following 6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
1143288|NCT00453154|O2|Outcome|Cohort 2|"Participants will receive the following combination chemotherapy for 6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle Sunitinib 37.5 mg oral, daily days 1-14 every cycle~Maintenance: Following 6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
1143289|NCT00453154|O1|Outcome|Cohort 1|"Participants will receive the following combination chemotherapy for 6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle Sunitinib 25 mg oral, daily days 1-14 every cycle~Maintenance: Following 6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
1143290|NCT00453154|E2|Reported Event|Arm II (Combination Chemotherapy + Placebo Maintenance)|Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression.
1143291|NCT00453154|E1|Reported Event|Arm I (Combination Chemotherapy + Sunitinib Maintenance)|Maintenance: Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression.
1143292|NCT00453102|B1|Baseline|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab~Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³~Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:~0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
1143293|NCT00453102|P1|Participant Flow|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab~Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³~Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:~0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
1143294|NCT00453102|O1|Outcome|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab~Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³~Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:~0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
1143295|NCT00453102|O1|Outcome|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab~Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³~Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:~0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
1143296|NCT00453102|O1|Outcome|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab~Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³~Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:~0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
1143297|NCT00453102|O1|Outcome|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab~Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³~Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:~0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
1143364|NCT00452699|O2|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
1143298|NCT00453102|O1|Outcome|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab~Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³~Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:~0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
1143299|NCT00453102|O1|Outcome|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab~Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³~Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:~0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
1143300|NCT00453102|E1|Reported Event|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab~Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³~Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:~0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
1143305|NCT00453063|P1|Participant Flow|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
1143306|NCT00453063|O2|Outcome|Placebo|Two sprays in each nostril once daily
1143307|NCT00453063|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
1143308|NCT00453063|O2|Outcome|Placebo|Two sprays in each nostril once daily
1143309|NCT00453063|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
1143310|NCT00453063|O2|Outcome|Placebo|Two sprays in each nostril once daily
1143311|NCT00453063|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
1143312|NCT00453063|O2|Outcome|Placebo|Two sprays in each nostril once daily
1143313|NCT00453063|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
1143314|NCT00453063|O2|Outcome|Placebo|Two sprays in each nostril once daily
1143315|NCT00453063|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
1143316|NCT00453063|E2|Reported Event|Placebo|Two sprays in each nostril once daily
1143317|NCT00453063|E1|Reported Event|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
1143318|NCT00452868|B1|Baseline|Donepezil|
1143319|NCT00452868|P1|Participant Flow|Donepezil|Patients less than 35 kilograms(kg): Donepezil 5 milligrams (mg) orally once every alternate day. Patients greater than 35 kg Donepezil 5 mg orally once per day. If there are no adverse effects noted on review of symptoms, the dose will be increased to 5 mg daily for patients < 35 kg. And to 10 mg/day for patients > 35 kg. This evaluation and dose escalation may be done as early as week 4. For all, donepezil will be administered 24 weeks.
1143320|NCT00452868|O1|Outcome|Donepezil|
1143321|NCT00452868|E1|Reported Event|Donepezil|
1143322|NCT00452790|B3|Baseline|Total|Total of all reporting groups
1143323|NCT00452790|B2|Baseline|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
1143324|NCT00452790|B1|Baseline|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
1143325|NCT00452790|P2|Participant Flow|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
1143326|NCT00452790|P1|Participant Flow|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
1143327|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
1148350|NCT00440115|B4|Baseline|Total|Total of all reporting groups
1143328|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
1143329|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
1143330|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
1143331|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
1143377|NCT00452673|B2|Baseline|70 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
1143542|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143332|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
1143333|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
1143334|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
1143335|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
1143336|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
1143337|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
1143338|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
1143339|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
1143340|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
1143341|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
1143342|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
1143365|NCT00452699|O1|Outcome|FSC DISKUS 250/50 mcg BID for 52 Weeks|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
1143343|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
1143344|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
1143345|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
1143346|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
1143347|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
1143348|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
1143349|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
1143350|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
1143351|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
1143352|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
1143353|NCT00452790|E6|Reported Event|Toddler Dose 7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 12 months of age (toddler dose).
1143354|NCT00452790|E5|Reported Event|Toddler Dose 13vPnC|Participants received 1 single 0.5 mL dose of 13vPnC, administered intramuscularly, at 12 months of age (toddler dose).
1143355|NCT00452790|E4|Reported Event|After the Infant Series 7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series), co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV). AEs were collected from approximately 1 month after Dose 3 to the Toddler dose.
1143356|NCT00452790|E3|Reported Event|After the Infant Series 13vPnC|Participants received 1 single 0.5 mL dose of 13vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series), co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV). AEs were collected from approximately 1 month after Dose 3 to the Toddler dose.
1143357|NCT00452790|E2|Reported Event|Infant Series 7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series), co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
1143358|NCT00452790|E1|Reported Event|Infant Series 13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series), co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
1143359|NCT00452699|B3|Baseline|Total|Total of all reporting groups
1143360|NCT00452699|B2|Baseline|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
1143366|NCT00452699|O2|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
1143367|NCT00452699|O1|Outcome|FSC DISKUS 250/50 mcg BID for 52 Weeks|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
1143368|NCT00452699|O2|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
1143369|NCT00452699|O1|Outcome|FSC DISKUS 250/50 mcg BID for 52 Weeks|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
1143370|NCT00452699|O2|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
1143371|NCT00452699|O1|Outcome|FSC DISKUS 250/50 mcg BID for 52 Weeks|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
1143372|NCT00452699|E2|Reported Event|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
1143373|NCT00452699|E1|Reported Event|FSC DISKUS 250/50 mcg BID for 52 Weeks|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
1143374|NCT00452673|B5|Baseline|Total|Total of all reporting groups
1143375|NCT00452673|B4|Baseline|100 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3A: 100 mg dasatinib oral tablet QD plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
1143376|NCT00452673|B3|Baseline|70 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
1143378|NCT00452673|B1|Baseline|50 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
1143379|NCT00452673|P5|Participant Flow|100 mg Dasatinib + 1000 mg/m^2Capecitabine (Dose Expansion)|No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for the dose expansion period in order to provide additional information regarding good tolerance of extended treatment. An additional 21 participants were treated in this arm in the Dose Expansion Period.
1143380|NCT00452673|P4|Participant Flow|100 mg Dasatinib + 1000 mg/m^2Capecitabine (Dose Escalation)|Dose Level 3A: 100 mg dasatinib oral tablet once daily (QD) plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
1143381|NCT00452673|P3|Participant Flow|70 mg Dasatinib + 1000 mg/m^2Capecitabine (Dose Escalation)|Dose Level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
1143382|NCT00452673|P2|Participant Flow|70 mg Dasatinib + 825 mg/m^2Capecitabine (Dose Escalation)|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
1143383|NCT00452673|P1|Participant Flow|50 mg Dasatinib + 825 mg/m^2Capecitabine (Dose Escalation)|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
1143384|NCT00452673|O4|Outcome|100 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3A: 100 mg dasatinib oral tablet QD plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
1143385|NCT00452673|O3|Outcome|70 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose Level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
1143386|NCT00452673|O2|Outcome|70 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
1143387|NCT00452673|O1|Outcome|50 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
1143435|NCT00452530|O1|Outcome|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
1143388|NCT00452673|O4|Outcome|100 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3A: 100 mg dasatinib oral tablet QD plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
1143389|NCT00452673|O3|Outcome|70 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose Level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
1143390|NCT00452673|O2|Outcome|70 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
1143391|NCT00452673|O1|Outcome|50 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
1143446|NCT00452530|E2|Reported Event|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
1143543|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143392|NCT00452673|O4|Outcome|100 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3A: 100 mg dasatinib oral tablet QD plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
1143393|NCT00452673|O3|Outcome|70 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
1143394|NCT00452673|O2|Outcome|70 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
1143395|NCT00452673|O1|Outcome|50 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
1143396|NCT00452673|O4|Outcome|100 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3A: 100 mg dasatinib oral tablet QD plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
1143397|NCT00452673|O3|Outcome|70 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
1143398|NCT00452673|O2|Outcome|70 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
1143399|NCT00452673|O1|Outcome|50 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
1143400|NCT00452673|O4|Outcome|100 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3A: 100 mg dasatinib oral tablet QD plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
1143401|NCT00452673|O3|Outcome|70 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
1143402|NCT00452673|O2|Outcome|70 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
1143403|NCT00452673|O1|Outcome|50 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
1143436|NCT00452530|O2|Outcome|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
1143525|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143404|NCT00452673|O4|Outcome|100 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3A: 100 mg dasatinib oral tablet QD plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
1143405|NCT00452673|O3|Outcome|70 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
1143406|NCT00452673|O2|Outcome|70 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
1143407|NCT00452673|O1|Outcome|50 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
1143408|NCT00452673|E4|Reported Event|100 mg Dasatinib + 1000 mg/m^2 Capecitabine|Dose Level 3A: 100 mg dasatinib oral tablet once daily (QD) plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
1143409|NCT00452673|E3|Reported Event|70 mg Dasatinib + 1000 mg/m^2 Capecitabine|Dose Level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
1143410|NCT00452673|E2|Reported Event|70 mg Dasatinib + 825 mg/m^2 Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
1143411|NCT00452673|E1|Reported Event|50 mg Dasatinib + 825 mg/m^2 Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
1143412|NCT00452543|B3|Baseline|Total|Total of all reporting groups
1143413|NCT00452543|B2|Baseline|Escitalopram Plus Placebo|Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
1143414|NCT00452543|B1|Baseline|Escitalopram Plus Acamprosate|Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
1143415|NCT00452543|P2|Participant Flow|Escitalopram Plus Placebo|Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
1143416|NCT00452543|P1|Participant Flow|Escitalopram Plus Acamprosate|Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
1143417|NCT00452543|O2|Outcome|Escitalopram Plus Placebo|Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
1143418|NCT00452543|O1|Outcome|Escitalopram Plus Acamprosate|Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
1143419|NCT00452543|O2|Outcome|Escitalopram Plus Placebo|Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
1143420|NCT00452543|O1|Outcome|Escitalopram Plus Acamprosate|Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
1143421|NCT00452543|O2|Outcome|Escitalopram Plus Placebo|Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
1143422|NCT00452543|O1|Outcome|Escitalopram Plus Acamprosate|Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
1143423|NCT00452543|O2|Outcome|Escitalopram Plus Placebo|Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
1143424|NCT00452543|O1|Outcome|Escitalopram Plus Acamprosate|Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
1143425|NCT00452543|E2|Reported Event|Escitalopram Plus Placebo|Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
1143426|NCT00452543|E1|Reported Event|Escitalopram Plus Acamprosate|Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
1143427|NCT00452530|B3|Baseline|Total|Total of all reporting groups
1143428|NCT00452530|B2|Baseline|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
1143429|NCT00452530|B1|Baseline|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
1143430|NCT00452530|P2|Participant Flow|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
1143431|NCT00452530|P1|Participant Flow|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
1143432|NCT00452530|O2|Outcome|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40-mg subcutaneous injection once daily (QD), plus a matching apixaban-placebo tablet 12 (±3) hours prior to hip-replacement surgery through 11 (±2) days after the day of surgery.
1143433|NCT00452530|O1|Outcome|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5-mg tablets twice daily (BID), plus a matching enoxaparin-placebo injection 12 (±3) hours prior to hip-replacement surgery through 11 (±2) days after the day of surgery.
1143434|NCT00452530|O2|Outcome|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
1143515|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143437|NCT00452530|O1|Outcome|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
1143438|NCT00452530|O2|Outcome|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
1143439|NCT00452530|O1|Outcome|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
1143440|NCT00452530|O2|Outcome|Enoxaparin, 40 mg QD|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
1143441|NCT00452530|O1|Outcome|Apixaban, 2.5 mg BID|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
1143442|NCT00452530|O2|Outcome|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
1143443|NCT00452530|O1|Outcome|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
1143444|NCT00452530|O2|Outcome|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
1143445|NCT00452530|O1|Outcome|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
1145602|NCT00445679|B2|Baseline|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
1143447|NCT00452530|E1|Reported Event|Apixiban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
1143448|NCT00452452|B4|Baseline|Total|Total of all reporting groups
1143449|NCT00452452|B3|Baseline|13vPnC 24 to < 72 Months of Age|Participants 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC.
1143450|NCT00452452|B2|Baseline|13vPnC 12 to <24 Months of Age|Participants 12 to < 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart.
1143451|NCT00452452|B1|Baseline|13vPnC 7 to <12 Months of Age|Participants 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
1143452|NCT00452452|P3|Participant Flow|13vPnC 24 to < 72 Months of Age|Participants 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC.
1143453|NCT00452452|P2|Participant Flow|13vPnC 12 to <24 Months of Age|Participants 12 to < 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart.
1143454|NCT00452452|P1|Participant Flow|13vPnC 7 to <12 Months of Age|Participants 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
1143455|NCT00452452|O3|Outcome|13vPnC 24 to < 72 Months of Age|Participants 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC.
1143456|NCT00452452|O2|Outcome|13vPnC 12 to <24 Months of Age|Participants 12 to < 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart.
1143457|NCT00452452|O1|Outcome|13vPnC 7 to <12 Months of Age|Participants 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
1143458|NCT00452452|O6|Outcome|13vPnC Group 1 - Dose 3|Participants received a third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
1143459|NCT00452452|O5|Outcome|13vPnC Group 2 - Dose 2|Participants 12 to < 24 months of age received a second single IM 0.5 mL doses of 13vPnC at least 56 days from the first (infant series).
1143460|NCT00452452|O4|Outcome|13vPnC Group 1 - Dose 2|Participants 7 to less than (<) 12 months of age received a second single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days after the first (infant series).
1143461|NCT00452452|O3|Outcome|13vPnC Group 3 - Dose 1|Participants 24 to < 72 months of age with 0 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series).
1143462|NCT00452452|O2|Outcome|13vPnC Group 2 - Dose 1|Participants 12 to < 24 months of age with 0 prior doses of Prevnar received a single IM 0.5 mL doses of 13vPnC (infant series).
1143463|NCT00452452|O1|Outcome|13vPnC Group 1 - Dose 1|Participants 7 to less than (<) 12 months of age with 0 prior doses of Prevnar received a single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC)(infant series).
1143464|NCT00452452|O6|Outcome|13vPnC Group 1 - Dose 3|Participants received a third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
1143465|NCT00452452|O5|Outcome|13vPnC Group 2 - Dose 2|Participants 12 to < 24 months of age received a second single IM 0.5 mL doses of 13vPnC at least 56 days from the first (infant series).
1143466|NCT00452452|O4|Outcome|13vPnC Group 1 - Dose 2|Participants 7 to less than (<) 12 months of age received a second single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days after the first (infant series).
1143467|NCT00452452|O3|Outcome|13vPnC Group 3 - Dose 1|Participants 24 to < 72 months of age with 0 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series).
1152959|NCT00428246|P1|Participant Flow|1|1 mcg paricalcitol
1143468|NCT00452452|O2|Outcome|13vPnC Group 2 - Dose 1|Participants 12 to < 24 months of age with 0 prior doses of Prevnar received a single IM 0.5 mL doses of 13vPnC (infant series).
1143469|NCT00452452|O1|Outcome|13vPnC Group 1 - Dose 1|Participants 7 to less than (<) 12 months of age with 0 prior doses of Prevnar received a single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC)(infant series).
1143470|NCT00452452|O3|Outcome|13vPnC 24 to < 72 Months of Age|Participants 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC.
1143471|NCT00452452|O2|Outcome|13vPnC 12 to <24 Months of Age|Participants 12 to < 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart.
1143472|NCT00452452|O1|Outcome|13vPnC 7 to <12 Months of Age|Participants 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
1143473|NCT00452452|E3|Reported Event|13vPnC 24 to < 72 Months of Age|Participants 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC.
1143539|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1149025|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
1143474|NCT00452452|E2|Reported Event|13vPnC 12 to <24 Months of Age|Participants 12 to < 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart.
1143475|NCT00452452|E1|Reported Event|13vPnC 7 to <12 Months of Age|Participants 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
1143476|NCT00452426|B3|Baseline|Total|Total of all reporting groups
1143477|NCT00452426|B2|Baseline|Current Standard of Care|Site's current standard used for delivery of sedation
1143478|NCT00452426|B1|Baseline|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
1143479|NCT00452426|P2|Participant Flow|Current Standard of Care|Site's current standard used for delivery of sedation
1143480|NCT00452426|P1|Participant Flow|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
1143481|NCT00452426|O2|Outcome|Current Standard of Care|Site's current standard used for delivery of sedation
1143482|NCT00452426|O1|Outcome|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
1143483|NCT00452426|O2|Outcome|Current Standard of Care|Site's current standard used for delivery of sedation
1143484|NCT00452426|O1|Outcome|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
1143485|NCT00452426|O2|Outcome|Current Standard of Care|Site's current standard used for delivery of sedation
1143486|NCT00452426|O1|Outcome|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
1143487|NCT00452426|O2|Outcome|Current Standard of Care|Site's current standard used for delivery of sedation
1143488|NCT00452426|O1|Outcome|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
1143489|NCT00452426|O2|Outcome|Current Standard of Care|Site's current standard used for delivery of sedation
1143490|NCT00452426|O1|Outcome|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
1143491|NCT00452426|E2|Reported Event|Current Standard of Care|Site's current standard used for delivery of sedation
1143492|NCT00452426|E1|Reported Event|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
1143493|NCT00452400|B6|Baseline|Total|Total of all reporting groups
1143494|NCT00452400|B5|Baseline|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143495|NCT00452400|B4|Baseline|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143496|NCT00452400|B3|Baseline|Olo 5 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143497|NCT00452400|B2|Baseline|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143498|NCT00452400|B1|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143499|NCT00452400|P5|Participant Flow|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143500|NCT00452400|P4|Participant Flow|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143501|NCT00452400|P3|Participant Flow|Olo 5 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143502|NCT00452400|P2|Participant Flow|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143503|NCT00452400|P1|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143504|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143505|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143506|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1143507|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143508|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143509|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143510|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143511|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1143512|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143513|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143514|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143526|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1143527|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143528|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143529|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143530|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143531|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1143532|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143533|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143534|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143535|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143536|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1143537|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143538|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1149026|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
1143544|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143545|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143546|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1143547|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143548|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143549|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143550|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143551|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1143552|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143553|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143554|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143555|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143556|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1143557|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143558|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143559|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143560|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143561|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1143562|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143563|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143564|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143565|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143566|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1143567|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143568|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143569|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143570|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143571|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1143572|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143573|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143574|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143575|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143576|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1143577|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143578|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143579|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143580|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143581|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1143582|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143583|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143584|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143585|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143586|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1143587|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143588|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143589|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143590|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143591|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1143592|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143593|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143594|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143595|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143596|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1143597|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143598|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143599|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143600|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143601|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1143602|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143603|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143604|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143605|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143606|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1143607|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143608|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143609|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143610|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143611|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1143612|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143613|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143614|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143615|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143616|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1143617|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143618|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143619|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143620|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143621|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1143622|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143623|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143624|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143625|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143626|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1143627|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143628|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143629|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143630|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143631|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1143632|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143633|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143634|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143635|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143636|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1143637|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143638|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143639|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143640|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143641|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1143642|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143643|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143644|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143645|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143646|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1143647|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143648|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143649|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143650|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143651|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1143652|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143653|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143654|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143655|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143656|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1143657|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143658|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143659|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143660|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143661|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1143662|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143663|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143664|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143665|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143666|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1143667|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143668|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143669|NCT00452400|E5|Reported Event|Olo 20 mcg|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
1143670|NCT00452400|E4|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1143671|NCT00452400|E3|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1143672|NCT00452400|E2|Reported Event|Olo 2 mcg|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
1143673|NCT00452400|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1143674|NCT00452387|B1|Baseline|Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib|The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
1143675|NCT00452387|P1|Participant Flow|Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib|The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
1143676|NCT00452387|O1|Outcome|Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib|The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
1143677|NCT00452387|O1|Outcome|Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib|The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
1143678|NCT00452387|O2|Outcome|Imaging Response (Unfavorable)|
1143679|NCT00452387|O1|Outcome|Imaging Response (Favorable)|
1143680|NCT00452387|O1|Outcome|Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib|The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
1143681|NCT00452387|E1|Reported Event|Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib|The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
1143682|NCT00452374|B1|Baseline|Oxaliplatin, Fludarabine, Cytarabine + Rituximab|Starting dose oxaliplatin 17.5mg/m^2/day intravenous (IV) for 4 days; Fludarabine 30 mg/m^2 IV and Cytarabine 1 g/m^2 IV for two days, + Rituximab 375 mg/m^2 IV on Day 3, Cycle 1 then Day 1 following cycles.
1143683|NCT00452374|P1|Participant Flow|Oxaliplatin, Fludarabine, Cytarabine + Rituximab|Starting dose oxaliplatin 17.5mg/m^2/day intravenous (IV) for 4 days; Fludarabine 30 mg/m^2 IV and Cytarabine 1 g/m^2 IV for two days, + Rituximab 375 mg/m^2 IV on Day 3, Cycle 1 then Day 1 following cycles.
1143684|NCT00452374|O1|Outcome|Oxaliplatin, Fludarabine, Cytarabine + Rituximab|Starting dose oxaliplatin 17.5mg/m^2/day intravenous (IV) for 4 days; Fludarabine 30 mg/m^2 IV and Cytarabine 1 g/m^2 IV for two days, + Rituximab 375 mg/m^2 IV on Day 3, Cycle 1 then Day 1 following cycles.
1143685|NCT00452374|O1|Outcome|Oxaliplatin, Fludarabine, Cytarabine + Rituximab|Starting dose oxaliplatin 17.5mg/m^2/day intravenous (IV) for 4 days; Fludarabine 30 mg/m^2 IV and Cytarabine 1 g/m^2 IV for two days, + Rituximab 375 mg/m^2 IV on Day 3, Cycle 1 then Day 1 following cycles.
1143686|NCT00452374|E1|Reported Event|Oxaliplatin, Fludarabine, Cytarabine + Rituximab|Starting dose oxaliplatin 17.5mg/m^2/day intravenous (IV) for 4 days; Fludarabine 30 mg/m^2 IV and Cytarabine 1 g/m^2 IV for two days, + Rituximab 375 mg/m^2 IV on Day 3, Cycle 1 then Day 1 following cycles.
1143687|NCT00452361|B3|Baseline|Total|Total of all reporting groups
1143688|NCT00452361|B2|Baseline|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
1143930|NCT00451282|B1|Baseline|Intervention|Injured children receiving Stepped Preventive Care intervention
1143689|NCT00452361|B1|Baseline|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
1143690|NCT00452361|P2|Participant Flow|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
1143691|NCT00452361|P1|Participant Flow|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
1145603|NCT00445679|B1|Baseline|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
1143692|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
1143693|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
1143694|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
1143695|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
1143696|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
1143697|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
1143698|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
1143762|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
1143763|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
1143931|NCT00451282|P2|Participant Flow|Usual Care|Injured children receiving usual care
1152960|NCT00428246|O3|Outcome|3|Placebo
1143699|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
1143700|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
1143701|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
1143702|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
1143703|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
1143704|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
1143705|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
1143706|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
1143707|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
1143708|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
1143764|NCT00452335|O2|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
1143765|NCT00452335|O1|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
1143766|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
1143709|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
1143710|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
1143711|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
1143712|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
1143713|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
1143714|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
1143715|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
1143716|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
1143717|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
1143718|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
1143767|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
1143768|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
1143769|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
1143719|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
1143720|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
1143721|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
1143722|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
1143723|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
1143724|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
1143725|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
1143726|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
1143727|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
1143728|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
1143770|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
1143771|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
1143772|NCT00452335|O3|Outcome|24 Mch BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
1143729|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
1143730|NCT00452361|E2|Reported Event|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
1143780|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
1143781|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
1143782|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
1144589|NCT00448708|P2|Participant Flow|Lifespan® ePTFE Vascular Graft|Lifespan® ePTFE Vascular Graft Only
1143731|NCT00452361|E1|Reported Event|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
1143732|NCT00452348|B3|Baseline|Total|Total of all reporting groups
1143733|NCT00452348|B2|Baseline|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
1143734|NCT00452348|B1|Baseline|FSC DISKUS 250/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
1143735|NCT00452348|P2|Participant Flow|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
1143736|NCT00452348|P1|Participant Flow|FSC DISKUS 250/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
1143737|NCT00452348|O2|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
1143738|NCT00452348|O1|Outcome|FSC DISKUS 250/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
1143739|NCT00452348|O2|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
1143740|NCT00452348|O1|Outcome|FSC DISKUS 250/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
1143741|NCT00452348|O2|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
1143742|NCT00452348|O1|Outcome|FSC DISKUS 250/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
1143743|NCT00452348|O2|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
1143744|NCT00452348|O1|Outcome|FSC DISKUS 250/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
1143745|NCT00452348|E2|Reported Event|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
1143746|NCT00452348|E1|Reported Event|FSC DISKUS 250/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
1143747|NCT00452335|B4|Baseline|Total|Total of all reporting groups
1143748|NCT00452335|B3|Baseline|24 mcg BID|Adolescents (12–17 years of age)and children (6–11 years of age) who are ≥36 kg body weight
1143749|NCT00452335|B2|Baseline|12 mcg BID|Up to 24 adolescents (12–17 years of age) and all children (6–11 years of age) who are at least 24 kg, but less than 36 kg, body weight
1143750|NCT00452335|B1|Baseline|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
1143751|NCT00452335|P3|Participant Flow|24 mcg BID|Adolescents (12–17 years of age)and children (6–11 years of age) who are ≥36 kg body weight
1143752|NCT00452335|P2|Participant Flow|12 mcg BID|Up to 24 adolescents (12–17 years of age) and all children (6–11 years of age) who are at least 24 kg, but less than 36 kg, body weight
1143753|NCT00452335|P1|Participant Flow|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
1143754|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
1143755|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
1143756|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
1143757|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
1143758|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
1143759|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
1143760|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
1143761|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
1143939|NCT00451282|O2|Outcome|Usual Care|Injured children receiving usual care
1143773|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
1143774|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
1143775|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
1143776|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
1143777|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
1143778|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
1143779|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
1143783|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
1143784|NCT00452335|E3|Reported Event|24 mcg BID|Adolescents (12–17 years of age)and children (6–11 years of age) who are ≥36 kg body weight
1143785|NCT00452335|E2|Reported Event|12 mcg BID|Up to 24 adolescents (12–17 years of age) and all children (6–11 years of age) who are at least 24 kg, but less than 36 kg, body weight
1143786|NCT00452335|E1|Reported Event|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
1143787|NCT00452114|B3|Baseline|Total|Total of all reporting groups
1143788|NCT00452114|B2|Baseline|Flutter Valve Device|flutter valve device delivers expiratory low-pressure vibratory pulse to the patient's airway when used daily
1143789|NCT00452114|B1|Baseline|In-Exsufflator Cough Assist Device|In-Exsufflator Cough Assist Device augments the expiratory flow and force of the patient's cough with the addition of a cycle of positive and negative inspiratory pressure when used daily
1143790|NCT00452114|P2|Participant Flow|Flutter Valve Device|flutter valve device delivers expiratory low-pressure vibratory pulse to the patient's airway when used daily
1143791|NCT00452114|P1|Participant Flow|In-Exsufflator Cough Assist Device|In-Exsufflator Cough Assist Device augments the expiratory flow and force of the patient's cough with the addition of a cycle of positive and negative inspiratory pressure when used daily
1143792|NCT00452114|O2|Outcome|Particpants in the Control Group (Flutter Device)|
1143793|NCT00452114|O1|Outcome|Participants in the Intervention Group (Cough In-exsufflator)|
1143794|NCT00452114|E2|Reported Event|Flutter Valve Device|flutter valve device delivers expiratory low-pressure vibratory pulse to the patient's airway when used daily
1143795|NCT00452114|E1|Reported Event|In-Exsufflator Cough Assist Device|In-Exsufflator Cough Assist Device augments the expiratory flow and force of the patient's cough with the addition of a cycle of positive and negative inspiratory pressure when used daily
1143796|NCT00451958|B5|Baseline|Total|Total of all reporting groups
1143797|NCT00451958|B4|Baseline|Leuprolide 7.5 mg / Degarelix 160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
1143798|NCT00451958|B3|Baseline|Leuprolide 7.5 mg / Degarelix 80 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
1143799|NCT00451958|B2|Baseline|Degarelix 160 mg / Degarelix 160 mg|"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
1143800|NCT00451958|B1|Baseline|Degarelix 80 mg / Degarelix 80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
1143801|NCT00451958|P5|Participant Flow|Leuprolide 7.5 mg|"During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~When the main CS21 study was completed these patients were switched to treatment with degarelix 80 mg or 160 mg in the CS21A study."
1143932|NCT00451282|P1|Participant Flow|Intervention|Injured children receiving Stepped Preventive Care intervention
1143933|NCT00451282|O2|Outcome|Usual Care|Injured children receiving usual care
1143802|NCT00451958|P4|Participant Flow|Leuprolide 7.5 mg / Degarelix 160 mg|"During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
1143803|NCT00451958|P3|Participant Flow|Leuprolide 7.5 mg / Degarelix 80 mg|"During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
1143825|NCT00451958|O1|Outcome|Degarelix 80 mg / Degarelix 80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
1143804|NCT00451958|P2|Participant Flow|Degarelix 160 mg / Degarelix 160 mg|"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 of the CS21 study (NCT00295750) as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the CS21 study and the current CS21A study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
1143805|NCT00451958|P1|Participant Flow|Degarelix 80 mg / Degarelix 80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 of the CS21 study (NCT00295750) as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the CS21 study and the current CS21A study.
1143806|NCT00451958|O2|Outcome|Leuprolide 7.5 mg/ Degarelix 240/160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
1143807|NCT00451958|O1|Outcome|Leuprolide 7.5 mg/ Degarelix 240/80 mg|"During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
1143808|NCT00451958|O2|Outcome|Leuprolide 7.5 mg/ Degarelix 240/160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
1143809|NCT00451958|O1|Outcome|Leuprolide 7.5 mg/ Degarelix 240/80 mg|"During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
1143810|NCT00451958|O2|Outcome|Leuprolide 7.5 mg/ Degarelix 240/160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
1143811|NCT00451958|O1|Outcome|Leuprolide 7.5 mg/ Degarelix 240/80 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
1143836|NCT00450866|P1|Participant Flow|Epothilone B (Group A)|Group A: Patients with progressive, radiographically measurable parenchymal brain metastases after whole brain radiation therapy (WBRT). Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
1143812|NCT00451958|O2|Outcome|Leuprolide 7.5 mg/ Degarelix 240/160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
1143813|NCT00451958|O1|Outcome|Leuprolide 7.5 mg/ Degarelix 240/80 mg|"During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
1143814|NCT00451958|O4|Outcome|Leuprolide 7.5 mg / Degarelix 160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Leuprolide participants who dropped out during the first year (i.e. during CS21) were all attributed to what became the leuprolide 7.5 mg / degarelix 160 mg arm.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
1143815|NCT00451958|O3|Outcome|Leuprolide 7.5 mg / Degarelix 80 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
1143816|NCT00451958|O2|Outcome|Degarelix 160 mg / Degarelix 160 mg|"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
1143817|NCT00451958|O1|Outcome|Degarelix 80 mg / Degarelix 80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
1143818|NCT00451958|O4|Outcome|Leuprolide 7.5 mg / Degarelix 160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
1143819|NCT00451958|O3|Outcome|Leuprolide 7.5 mg / Degarelix 80 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
1143820|NCT00451958|O2|Outcome|Degarelix 160 mg / Degarelix 160 mg|"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
1143821|NCT00451958|O1|Outcome|Degarelix 80 mg / Degarelix 80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
1143822|NCT00451958|O4|Outcome|Leuprolide 7.5 mg / Degarelix 160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
1143837|NCT00450866|O1|Outcome|Epothilone B (Groups A and B)|Epothilone B : Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
1143823|NCT00451958|O3|Outcome|Leuprolide 7.5 mg / Degarelix 80 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
1143824|NCT00451958|O2|Outcome|Degarelix 160 mg / Degarelix 160 mg|"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
1143883|NCT00451698|B3|Baseline|Total|Total of all reporting groups
1144590|NCT00448708|P1|Participant Flow|Vascular Wrap and Graft|Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
1143826|NCT00451958|O4|Outcome|Leuprolide 7.5 mg / Degarelix 160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
1143827|NCT00451958|O3|Outcome|Leuprolide 7.5 mg / Degarelix 80 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
1143828|NCT00451958|O2|Outcome|Degarelix 160 mg / Degarelix 160 mg|"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
1143829|NCT00451958|O1|Outcome|Degarelix 80 mg / Degarelix 80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
1143830|NCT00451958|E4|Reported Event|Leuprolide 7.5 mg / Degarelix 160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
1143831|NCT00451958|E3|Reported Event|Leuprolide 7.5 mg / Degarelix 80 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
1143832|NCT00451958|E2|Reported Event|Degarelix 160 mg / Degarelix 160 mg|"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
1143833|NCT00451958|E1|Reported Event|Degarelix 80 mg / Degarelix 80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
1143834|NCT00450866|B1|Baseline|Epothilone B (Groups A and B)|Epothilone B : Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
1143835|NCT00450866|P2|Participant Flow|Epothilone B (Group B)|Group B: an exploratory cohort of patients, with either leptomeningeal metastases (LMD) or unirradiated, asymptomatic brain metastasis from breast cancer (BCBM).Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
1143838|NCT00450866|O1|Outcome|Epothilone B (Groups A and B)|Epothilone B : Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
1143839|NCT00450866|O2|Outcome|Epothilone B: Group B|Group B: an exploratory cohort of patients, with either leptomeningeal metastases (LMD) or unirradiated, asymptomatic brain metastasis from breast cancer (BCBM).Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
1143840|NCT00450866|O1|Outcome|Epothilone B: Group A|Group A: Patients with progressive, radiographically measurable parenchymal brain metastases after whole brain radiation therapy (WBRT). Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
1143841|NCT00450866|O1|Outcome|Epothilone B (Groups A and B)|Epothilone B : Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
1143842|NCT00450866|O2|Outcome|Epothilone B: Group B|Group B: an exploratory cohort of patients, with either leptomeningeal metastases (LMD) or unirradiated, asymptomatic brain metastasis from breast cancer (BCBM).Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
1143884|NCT00451698|B2|Baseline|Acyanotic Study Drug|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug
1143843|NCT00450866|O1|Outcome|Epothilone B: Group A|Group A: Patients with progressive, radiographically measurable parenchymal brain metastases after whole brain radiation therapy (WBRT). Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
1143844|NCT00450866|E1|Reported Event|Epothilone B (Groups A and B)|Epothilone B : Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
1143845|NCT00450801|B1|Baseline|R-MACLO-IVAM-T|Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (cycle 1), followed by Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (cycle 2). These two cycles are repeated once, and patients achieving complete repose receive maintenance Thalidomide.
1143846|NCT00450801|P1|Participant Flow|R-MACLO-IVAM-T|Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (cycle 1), followed by Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (cycle 2). These two cycles are repeated once, and patients achieving complete repose receive maintenance Thalidomide.
1143847|NCT00450801|O3|Outcome|Thalidomide Therapy|Number of patients experiencing adverse events during Thalidomide maintenance therapy.
1143848|NCT00450801|O2|Outcome|R-IVAM Cycles|Number of patients experiencing adverse events during the Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (R-IVAM) treatment cycles.
1143849|NCT00450801|O1|Outcome|R-MACLO Cycles|Number of patients experiencing adverse events during the combination Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (R-MACLO) treatment cycles.
1143850|NCT00450801|O1|Outcome|R-MACLO-IVAM-T|Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (cycle 1), followed by Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (cycle 2). These two cycles are repeated once, and patients achieving complete repose receive maintenance Thalidomide.
1143851|NCT00450801|O1|Outcome|R-MACLO-IVAM-T|Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (cycle 1), followed by Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (cycle 2). These two cycles are repeated once, and patients achieving complete repose receive maintenance Thalidomide.
1143852|NCT00450801|O1|Outcome|R-MACLO-IVAM-T|Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (cycle 1), followed by Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (cycle 2). These two cycles are repeated once, and patients achieving complete repose receive maintenance Thalidomide.
1143853|NCT00450801|E3|Reported Event|Thalidomide Therapy|Adverse Events occurring during Thalidomide maintenance therapy.
1143854|NCT00450801|E2|Reported Event|R-IVAM Cycles|Adverse Events occurring during the Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (R-IVAM) treatment cycles.
1143855|NCT00450801|E1|Reported Event|R-MACLO Cycles|Adverse Events occurring during the combination Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (R-MACLO) treatment cycles.
1143856|NCT00450749|B4|Baseline|Total|Total of all reporting groups
1143857|NCT00450749|B3|Baseline|Arm III High-Dose Lycopene|60 mg/day oral Lycopene for 4-7 weeks.
1143858|NCT00450749|B2|Baseline|Arm II Low Dose Lycopene|30 mg/day oral Lycopene for 4-7 weeks.
1143859|NCT00450749|B1|Baseline|Arm I Placebo|Placebo once daily for 4-7 weeks.
1143860|NCT00450749|P3|Participant Flow|Arm III High-Dose Lycopene|60 mg/day oral Lycopene for 4-7 weeks.
1143861|NCT00450749|P2|Participant Flow|Arm II Low Dose Lycopene|30 mg/day oral Lycopene for 4-7 weeks.
1143862|NCT00450749|P1|Participant Flow|Arm I Placebo|Placebo once daily for 4-7 weeks.
1143863|NCT00450749|O3|Outcome|Arm III High-Dose Lycopene|60 mg/day oral Lycopene for 4-7 weeks.
1143864|NCT00450749|O2|Outcome|Arm II Low Dose Lycopene|30 mg/day oral Lycopene for 4-7 weeks.
1143865|NCT00450749|O1|Outcome|Arm I Placebo|Placebo once daily for 4-7 weeks.
1143866|NCT00450749|E3|Reported Event|Arm III High-Dose Lycopene|60 mg/day oral Lycopene for 4-7 weeks.
1143867|NCT00450749|E2|Reported Event|Arm II Low Dose Lycopene|30 mg/day oral Lycopene for 4-7 weeks.
1143868|NCT00450749|E1|Reported Event|Arm I Placebo|Placebo once daily for 4-7 weeks.
1143869|NCT00450723|B1|Baseline|Single Arm|
1143870|NCT00450723|P1|Participant Flow|Sentinel Lymph Node Biopsy|
1143871|NCT00450723|O1|Outcome|Sentinel Lymph Node BIopsy|
1143872|NCT00450723|O1|Outcome|Sentinel Lymph Node Biopsy|
1143873|NCT00450723|O1|Outcome|Sentinel Lymph Node Biopsy|
1143874|NCT00450723|E1|Reported Event|Single Arm|
1143921|NCT00451451|O2|Outcome|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
1143922|NCT00451451|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
1143923|NCT00451451|E5|Reported Event|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
1143924|NCT00451451|E4|Reported Event|Total BG00012|Combined BG00012 240 mg twice daily (BID) dose group and BG00012 240 mg 3 times daily (TID) dose group
1152961|NCT00428246|O2|Outcome|2|2 mcg paricalcitol
1143875|NCT00451906|B1|Baseline|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator’s choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
1143885|NCT00451698|B1|Baseline|Acyanotic Placebo|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% _ Received placebo
1143886|NCT00451698|P2|Participant Flow|Acyanotic Study Drug|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug
1144591|NCT00448708|O2|Outcome|Lifespan® ePTFE Vascular Graft|Lifespan® ePTFE Vascular Graft Only
1143876|NCT00451906|P1|Participant Flow|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator’s choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
1143877|NCT00451906|O1|Outcome|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator’s choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
1143878|NCT00451906|O1|Outcome|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator’s choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
1143879|NCT00451906|O1|Outcome|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator’s choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
1143880|NCT00451906|O1|Outcome|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator’s choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
1143881|NCT00451906|O1|Outcome|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator’s choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
1143925|NCT00451451|E3|Reported Event|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
1143926|NCT00451451|E2|Reported Event|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
1143927|NCT00451451|E1|Reported Event|Placebo|Participants received two placebo capsules orally three times daily (TID)
1143928|NCT00451282|B3|Baseline|Total|Total of all reporting groups
1143929|NCT00451282|B2|Baseline|Usual Care|Injured children receiving usual care
1152962|NCT00428246|O1|Outcome|1|1 mcg paricalcitol
1143882|NCT00451906|E1|Reported Event|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator’s choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
1143887|NCT00451698|P1|Participant Flow|Acyanotic Placebo|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% _ Received placebo
1143888|NCT00451698|O2|Outcome|Acyanotic Study Drug|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug
1143889|NCT00451698|O1|Outcome|Acyanotic Placebo|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% _ Received placebo
1143890|NCT00451698|O2|Outcome|Acyanotic Study Drug|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug
1143891|NCT00451698|O1|Outcome|Acyanotic Placebo|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% _ Received placebo
1143892|NCT00451698|E2|Reported Event|Acyanotic Study Drug|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug
1143893|NCT00451698|E1|Reported Event|Acyanotic Placebo|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% _ Received placebo
1143894|NCT00451451|B5|Baseline|Total|Total of all reporting groups
1143895|NCT00451451|B4|Baseline|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
1143896|NCT00451451|B3|Baseline|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
1143897|NCT00451451|B2|Baseline|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
1143898|NCT00451451|B1|Baseline|Placebo|Participants received two placebo capsules orally three times daily (TID)
1143899|NCT00451451|P4|Participant Flow|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
1143900|NCT00451451|P3|Participant Flow|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
1143901|NCT00451451|P2|Participant Flow|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
1143902|NCT00451451|P1|Participant Flow|Placebo|Participants received two placebo capsules orally three times daily (TID)
1143903|NCT00451451|O4|Outcome|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
1143904|NCT00451451|O3|Outcome|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
1143905|NCT00451451|O2|Outcome|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
1143906|NCT00451451|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
1143907|NCT00451451|O4|Outcome|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
1143908|NCT00451451|O3|Outcome|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
1143909|NCT00451451|O2|Outcome|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
1143910|NCT00451451|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
1143911|NCT00451451|O4|Outcome|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
1143912|NCT00451451|O3|Outcome|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
1143913|NCT00451451|O2|Outcome|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
1143914|NCT00451451|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
1143915|NCT00451451|O4|Outcome|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
1143916|NCT00451451|O3|Outcome|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
1143917|NCT00451451|O2|Outcome|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
1143918|NCT00451451|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
1143919|NCT00451451|O4|Outcome|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received Glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
1143920|NCT00451451|O3|Outcome|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
1143940|NCT00451282|O1|Outcome|Intervention|Injured children receiving Stepped Preventive Care intervention
1143941|NCT00451282|E2|Reported Event|Usual Care|Injured children receiving usual care
1143942|NCT00451282|E1|Reported Event|Intervention|Injured children receiving Stepped Preventive Care intervention
1143943|NCT00451204|B3|Baseline|Total|Total of all reporting groups
1143944|NCT00451204|B2|Baseline|Placebo Capsules Plus Copaxone Injections|Placebo: Placebo capsule, once a day, treatment duration is 2 years
1143945|NCT00451204|B1|Baseline|Estriol Capsules Plus Copaxone Injections|Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
1143946|NCT00451204|P2|Participant Flow|Placebo Capsules Plus Copaxone Injections|Placebo: Placebo capsule, once per day, treatment duration is 2 years
1143947|NCT00451204|P1|Participant Flow|Estriol Capsules Plus Copaxone Injections|Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
1143948|NCT00451204|O2|Outcome|Placebo Capsules Plus Copaxone Injections|Placebo capsule, once a day, treatment duration is 2 years
1143949|NCT00451204|O1|Outcome|Estriol Capsules Plus Copaxone Injections|Estriol 8 mg capsule, once per day, duration of treatment is 2 years
1143950|NCT00451204|O2|Outcome|Placebo Capsules Plus Copaxone Injections|Placebo capsule, once a day, treatment duration is 2 years
1145604|NCT00445679|P4|Participant Flow|Paroxetine 20|Paroxetine 20 mg/day
1143951|NCT00451204|O1|Outcome|Estriol Capsules Plus Copaxone Injections|Estriol 8 mg capsule, once per day, duration of treatment is 2 years
1143952|NCT00451204|O2|Outcome|Placebo Capsules Plus Copaxone Injections|Placebo: Placebo capsule, once per day, treatment duration is 2 years
1143953|NCT00451204|O1|Outcome|Estriol Capsules Plus Copaxone Injections|Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
1143954|NCT00451204|O2|Outcome|Placebo Capsules Plus Copaxone Injections|Placebo: Placebo capsule, once per day, treatment duration is 2 years
1143955|NCT00451204|O1|Outcome|Estriol Capsules Plus Copaxone Injections|Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
1143956|NCT00451204|O2|Outcome|Placebo Capsules Plus Copaxone Injections|Placebo: Placebo capsule, once per day, treatment duration is 2 years
1143957|NCT00451204|O1|Outcome|Estriol Capsules Plus Copaxone Injections|Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
1143958|NCT00451204|O2|Outcome|Placebo Capsules Plus Copaxone Injections|Placebo: Placebo capsule, once a day, treatment duration is 2 years
1143959|NCT00451204|O1|Outcome|Estriol Capsules Plus Copaxone Injections|Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
1143960|NCT00451204|E2|Reported Event|Placebo Capsules Plus Copaxone Injections|Placebo: Placebo capsule, once a day, treatment duration is 2 years
1143961|NCT00451204|E1|Reported Event|Estriol Capsules Plus Copaxone Injections|Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
1143962|NCT00451191|B3|Baseline|Total|Total of all reporting groups
1143963|NCT00451191|B2|Baseline|300 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
1143964|NCT00451191|B1|Baseline|100 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
1143965|NCT00451191|P2|Participant Flow|300 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
1143966|NCT00451191|P1|Participant Flow|100 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
1143967|NCT00451191|O2|Outcome|300 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
1143968|NCT00451191|O1|Outcome|100 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
1143969|NCT00451191|E2|Reported Event|300 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
1143970|NCT00451191|E1|Reported Event|100 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
1143971|NCT00451048|B1|Baseline|Arm I|"Patients will receive sunitinib by mouth once a day. Treatment may continue for as long as benefit is shown.~sunitinib malate: Given orally"
1143972|NCT00451048|P1|Participant Flow|Arm I|"Patients will receive sunitinib by mouth once a day. Treatment may continue for as long as benefit is shown.~sunitinib malate: Given orally"
1143973|NCT00451048|O1|Outcome|Arm I|"Patients will receive sunitinib by mouth once a day. Treatment may continue for as long as benefit is shown.~sunitinib malate: Given orally"
1143974|NCT00451048|E1|Reported Event|Arm I|"Patients will receive sunitinib by mouth once a day. Treatment may continue for as long as benefit is shown.~sunitinib malate: Given orally"
1143975|NCT00450983|B1|Baseline|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
1143976|NCT00450983|P1|Participant Flow|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
1143977|NCT00450983|O1|Outcome|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
1143978|NCT00450983|O1|Outcome|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
1143979|NCT00450983|O1|Outcome|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
1143980|NCT00450983|O1|Outcome|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
1143981|NCT00450983|O1|Outcome|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
1143982|NCT00450983|O1|Outcome|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
1143983|NCT00450983|O1|Outcome|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
1143984|NCT00450983|O1|Outcome|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
1143985|NCT00450983|O1|Outcome|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
1143986|NCT00450983|E1|Reported Event|Treatment|Following total-body irradiation, thiotepa, fludarabine, and muromonab-CD3, participants are given a donor peripheral stem cell transplant and a donor natural killer cell transplant.
1143987|NCT00450658|B3|Baseline|Total|Total of all reporting groups
1143988|NCT00450658|B2|Baseline|Ibuprofen|Ibuprofen 800mg
1143989|NCT00450658|B1|Baseline|HZT-501|HZT-501: Ibuprofen 800mg/Famotidine 26.6mg
1143990|NCT00450658|P2|Participant Flow|Ibuprofen|Ibuprofen 800mg tablets t.i.d.
1143991|NCT00450658|P1|Participant Flow|HZT-501|HZT-501: Ibuprofen 800mg/Famotidine 26.6mg tablets t.i.d.
1143992|NCT00450658|O2|Outcome|Ibuprofen|Ibuprofen 800mg
1143993|NCT00450658|O1|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/Famotidine 26.6mg
1143994|NCT00450658|O2|Outcome|Ibuprofen|Ibuprofen 800mg
1143995|NCT00450658|O1|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/Famotidine 26.6mg
1143996|NCT00450658|O2|Outcome|Ibuprofen|Ibuprofen 800mg
1143997|NCT00450658|O1|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/Famotidine 26.6mg
1143998|NCT00450658|O2|Outcome|Ibuprofen|Ibuprofen 800mg
1143999|NCT00450658|O1|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/Famotidine 26.6mg
1144000|NCT00450658|E2|Reported Event|Ibuprofen|Ibuprofen 800mg
1144001|NCT00450658|E1|Reported Event|HZT-501|HZT-501: Ibuprofen 800mg/Famotidine 26.6mg
1144002|NCT00450619|B3|Baseline|Total|Total of all reporting groups
1144003|NCT00450619|B2|Baseline|Arm B - 153SmEDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
1144004|NCT00450619|B1|Baseline|Arm A -EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
1144005|NCT00450619|P2|Participant Flow|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
1144006|NCT00450619|P1|Participant Flow|Arm A- EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
1144007|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
1144008|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
1144009|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
1144010|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
1144011|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
1144592|NCT00448708|O1|Outcome|Vascular Wrap and Graft|Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
1144012|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
1144013|NCT00450619|O1|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
1144014|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
1144015|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
1144016|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
1144017|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
1144018|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
1144019|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
1144020|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
1144021|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
1144022|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
1144023|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
1144024|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
1144025|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
1144026|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
1144069|NCT00450450|O2|Outcome|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
1144070|NCT00450450|O1|Outcome|Control BM Arm|Conventional bone marrow transplant (BM)
1144071|NCT00450450|O2|Outcome|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
1144027|NCT00450619|E2|Reported Event|Arm B - 153SmEDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
1144028|NCT00450619|E1|Reported Event|Arm A -EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
1144029|NCT00450580|B3|Baseline|Total|Total of all reporting groups
1144030|NCT00450580|B2|Baseline|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
1144031|NCT00450580|B1|Baseline|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
1144032|NCT00450580|P2|Participant Flow|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
1144033|NCT00450580|P1|Participant Flow|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
1144034|NCT00450580|O2|Outcome|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
1144035|NCT00450580|O1|Outcome|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
1144036|NCT00450580|O2|Outcome|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
1144037|NCT00450580|O1|Outcome|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
1144038|NCT00450580|O2|Outcome|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
1144039|NCT00450580|O1|Outcome|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
1144040|NCT00450580|O2|Outcome|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
1144041|NCT00450580|O1|Outcome|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
1144042|NCT00450580|O2|Outcome|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
1144043|NCT00450580|O1|Outcome|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
1144044|NCT00450580|O2|Outcome|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
1144045|NCT00450580|O1|Outcome|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
1144046|NCT00450580|O2|Outcome|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
1144047|NCT00450580|O1|Outcome|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
1144048|NCT00450580|E2|Reported Event|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
1144049|NCT00450580|E1|Reported Event|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
1144050|NCT00450450|B3|Baseline|Total|Total of all reporting groups
1144051|NCT00450450|B2|Baseline|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
1144052|NCT00450450|B1|Baseline|Control BM Arm|Conventional bone marrow transplant (BM)
1144053|NCT00450450|P2|Participant Flow|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
1144054|NCT00450450|P1|Participant Flow|Control BM Arm|Conventional bone marrow transplant (BM)
1144055|NCT00450450|O2|Outcome|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
1144056|NCT00450450|O1|Outcome|Control BM Arm|Conventional bone marrow transplant (BM)
1144057|NCT00450450|O2|Outcome|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
1144058|NCT00450450|O1|Outcome|Control BM Arm|Conventional bone marrow transplant (BM)
1144059|NCT00450450|O2|Outcome|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
1144060|NCT00450450|O1|Outcome|Control BM Arm|Conventional bone marrow transplant (BM)
1144061|NCT00450450|O2|Outcome|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
1144062|NCT00450450|O1|Outcome|Control BM Arm|Conventional bone marrow transplant (BM)
1144063|NCT00450450|O2|Outcome|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
1144064|NCT00450450|O1|Outcome|Control BM Arm|Conventional bone marrow transplant (BM)
1144065|NCT00450450|O2|Outcome|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
1144066|NCT00450450|O1|Outcome|Control BM Arm|Conventional bone marrow transplant (BM)
1144067|NCT00450450|O2|Outcome|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
1144068|NCT00450450|O1|Outcome|Control BM Arm|Conventional bone marrow transplant (BM)
1144072|NCT00450450|O1|Outcome|Control BM Arm|Conventional bone marrow transplant (BM)
1144073|NCT00450450|E2|Reported Event|Experimental G-BM Arm|G-CSF (filgrastim) stimulated bone marrow (G-BM)
1144074|NCT00450450|E1|Reported Event|Control BM Arm|Conventional bone marrow transplant (BM)
1144075|NCT00450437|B3|Baseline|Total|Total of all reporting groups
1144076|NCT00450437|B2|Baseline|Licensed Meningococcal Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
1144077|NCT00450437|B1|Baseline|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY (three lots combined) conjugate vaccine was administered intramuscularly.
1144078|NCT00450437|P4|Participant Flow|Licensed Meningococcal Vaccine (19 to 55 Years)|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine (supplied as a single 0.5 mL injection) was administered intramuscularly.
1144079|NCT00450437|P3|Participant Flow|Novartis MenACWY Vaccine (19 to 55 Years)|One dose of the Novartis meningococcal ACWY conjugate vaccine (obtained by extemporaneous mixing of components before injection) was administered intramuscularly.
1144080|NCT00450437|P2|Participant Flow|Licensed Meningococcal Vaccine (11 to 18 Years)|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine (supplied as a single 0.5 mL injection) was administered intramuscularly.
1144081|NCT00450437|P1|Participant Flow|Novartis MenACWY Vaccine (11 to 18 Years)|One dose of the Novartis meningococcal ACWY conjugate vaccine (obtained by extemporaneous mixing of components before injection) was administered intramuscularly.
1144082|NCT00450437|O2|Outcome|Licensed Meningococcal Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
1144083|NCT00450437|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly.
1144084|NCT00450437|O2|Outcome|Licensed Meningococcal Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
1144085|NCT00450437|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly.
1144086|NCT00450437|O2|Outcome|Licensed Meningococcal Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
1144087|NCT00450437|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly.
1144088|NCT00450437|O2|Outcome|Licensed Meningococcal Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
1144089|NCT00450437|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly.
1144090|NCT00450437|O3|Outcome|Novartis MenACWY Lot 3|One dose of the meningococcal ACWY Lot 3 conjugate vaccine was administered intramuscularly.
1144091|NCT00450437|O2|Outcome|Novartis MenACWY Lot 2|One dose of the meningococcal ACWY Lot 2 conjugate vaccine was administered intramuscularly.
1144092|NCT00450437|O1|Outcome|Novartis MenACWY Lot 1|One dose of the meningococcal ACWY Lot 1 conjugate vaccine was administered intramuscularly.
1144093|NCT00450437|O2|Outcome|Licensed Meningococcal Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
1144094|NCT00450437|O1|Outcome|Novartis MenACWY Vaccine|One dose of the meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly.
1144095|NCT00450437|O2|Outcome|Licensed Meninogcoccal Vaccine|One vaccination of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
1144096|NCT00450437|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly.
1144097|NCT00450437|O3|Outcome|Novartis MenACWY Lot 3|One dose of the Novartis meningococcal ACWY Lot 3 vaccine was administered intramuscularly.
1144098|NCT00450437|O2|Outcome|Novartis MenACWY Lot 2|One dose of the Novartis meningococcal ACWY Lot 2 vaccine was administered intramuscularly.
1144099|NCT00450437|O1|Outcome|Novartis MenACWY Lot 1|One dose of the Novartis meningococcal ACWY conjugate Lot 1 vaccine was administered intramuscularly.
1144100|NCT00450437|E2|Reported Event|Licensed Meningococcal Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly, 11 to 55 years of age.
1144101|NCT00450437|E1|Reported Event|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine (three lots combined) was administered intramuscularly, 11 to 55 years of age.
1144102|NCT00450424|B3|Baseline|Total|Total of all reporting groups
1144103|NCT00450424|B2|Baseline|CD-ROM Condition|Participants who are randomized to the CD-ROM condition will complete the baseline interview and then meet with the health educator who will provide the participant with the standard MSI consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. Next, the participant will be provided with the CD-ROM to view on a laptop computer in the clinic. Participants will also be given a copy of the CD-ROM to take home and keep for future reference. The CD-ROM patients will sign (or not sign, if they do not consent or wish to think further about the decision) the consent form after this discussion.
1144104|NCT00450424|B1|Baseline|Standard Consent Condition|Participants in the Standard consent condition will complete the baseline interview and then meet with the study health educator who will provide the participant with the standard MSI informed consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. The patients will either sign (or not sign, if they do not consent to have the test, or wish to think further about the decision) after this discussion. Participants who have further questions will be referred to either the attending physician or the genetics counselor at each hospital site.
1144135|NCT00450333|O2|Outcome|Dynepo-naive Twice-weekly (BIW)|EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
1144136|NCT00450333|O1|Outcome|Dynepo (Epoetin Delta)-Naive Once-weekly (QW)|Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
1144137|NCT00450333|O4|Outcome|Dynepo QW|EPO stable subjects receiving Epoetin delta once weekly (QW)
1152963|NCT00428246|E3|Reported Event|3|Placebo
1144105|NCT00450424|P2|Participant Flow|Standard Consent Condition|Participants in the Standard consent condition will complete the baseline interview and then meet with the study health educator who will provide the participant with the standard MSI informed consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. The patients will either sign (or not sign, if they do not consent to have the test, or wish to think further about the decision) after this discussion. Participants who have further questions will be referred to either the attending physician or the genetics counselor.
1144106|NCT00450424|P1|Participant Flow|CD-ROM Condition|Participants who are randomized to the CD-ROM condition will complete the baseline interview and then meet with the health educator who will provide the participant with the standard MSI consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. Next, the participant will be provided with the CD-ROM to view on a laptop computer in the clinic. Participants will also be given a copy of the CD-ROM to take home and keep for future reference. The CD-ROM patients will sign (or not sign, if they do not consent or wish to think further about the decision) the consent form after this discussion.
1144107|NCT00450424|O2|Outcome|CD-ROM Condition|Participants who are randomized to the CD-ROM condition will complete the baseline interview and then meet with the health educator who will provide the participant with the standard MSI consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. Next, the participant will be provided with the CD-ROM to view on a laptop computer in the clinic. Participants will also be given a copy of the CD-ROM to take home and keep for future reference. The CD-ROM patients will sign (or not sign, if they do not consent or wish to think further about the decision) the consent form after this discussion.
1144108|NCT00450424|O1|Outcome|Standard Consent Condition|Participants in the Standard consent condition will complete the baseline interview and then meet with the study health educator who will provide the participant with the standard MSI informed consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. The patients will either sign (or not sign, if they do not consent to have the test, or wish to think further about the decision) after this discussion. Participants who have further questions will be referred to either the attending physician or the genetics counselor at each hospital site.
1144109|NCT00450424|E2|Reported Event|CD-ROM Condition|Participants who are randomized to the CD-ROM condition will complete the baseline interview and then meet with the health educator who will provide the participant with the standard MSI consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. Next, the participant will be provided with the CD-ROM to view on a laptop computer in the clinic. Participants will also be given a copy of the CD-ROM to take home and keep for future reference. The CD-ROM patients will sign (or not sign, if they do not consent or wish to think further about the decision) the consent form after this discussion.
1144110|NCT00450424|E1|Reported Event|Standard Consent Condition|Participants in the Standard consent condition will complete the baseline interview and then meet with the study health educator who will provide the participant with the standard MSI informed consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. The patients will either sign (or not sign, if they do not consent to have the test, or wish to think further about the decision) after this discussion. Participants who have further questions will be referred to either the attending physician or the genetics counselor at each hospital site.
1144111|NCT00450372|B1|Baseline|Single Arm|
1144112|NCT00450372|P1|Participant Flow|Single Arm|
1144113|NCT00450372|O2|Outcome|ADI-PEG 20: Argininosuccinate Synthetase Negative (ASS-)|Patients without ASS expression in tumor
1144114|NCT00450372|O1|Outcome|ADI-PEG 20: Argininosuccinate Synthetase Positive (ASS+)|Patients with ASS expression present in tumor
1144115|NCT00450372|O2|Outcome|ADI-PEG 20: Argininosuccinate Synthetase Negative (ASS-)|Patients without ASS expression in tumor
1144116|NCT00450372|O1|Outcome|ADI-PEG 20: Argininosuccinate Synthetase Positive (ASS+)|Patients with ASS expression present in tumor
1144117|NCT00450372|O2|Outcome|ADI-PEG 20: Argininosuccinate Synthetase Negative (ASS-)|Patients without Argininosuccinate Synthetase (ASS) expression present in tumor
1144118|NCT00450372|O1|Outcome|ADI-PED 20: Argininosuccinate Synthetase Positive (ASS+)|Patients with Argininosuccinate Synthetase (ASS) expression present in tumor
1144119|NCT00450372|E1|Reported Event|Single Arm|
1144120|NCT00450333|B5|Baseline|Total|Total of all reporting groups
1144121|NCT00450333|B4|Baseline|Dynepo QW|EPO stable subjects receiving Epoetin delta once weekly (QW)
1144122|NCT00450333|B3|Baseline|Dynepo Once Every 2 Weeks (Q2W)|EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
1144123|NCT00450333|B2|Baseline|Dynepo-naive Twice-weekly (BIW)|EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
1144124|NCT00450333|B1|Baseline|Dynepo (Epoetin Delta)-Naive Once-weekly (QW)|Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
1144125|NCT00450333|P4|Participant Flow|Dynepo QW|EPO stable subjects receiving Epoetin delta once weekly (QW)
1144126|NCT00450333|P3|Participant Flow|Dynepo Once Every 2 Weeks (Q2W)|EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
1144127|NCT00450333|P2|Participant Flow|Dynepo-naive Twice-weekly (BIW)|EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
1144128|NCT00450333|P1|Participant Flow|Dynepo (Epoetin Delta)-Naive Once-weekly (QW)|Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
1144129|NCT00450333|O4|Outcome|Dynepo QW|EPO stable subjects receiving Epoetin delta once weekly (QW)
1144130|NCT00450333|O3|Outcome|Dynepo Once Every 2 Weeks (Q2W)|EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
1144131|NCT00450333|O2|Outcome|Dynepo-naive Twice-weekly (BIW)|EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
1144132|NCT00450333|O1|Outcome|Dynepo (Epoetin Delta)-Naive Once-weekly (QW)|Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
1144133|NCT00450333|O4|Outcome|Dynepo QW|EPO stable subjects receiving Epoetin delta once weekly (QW)
1144134|NCT00450333|O3|Outcome|Dynepo Once Every 2 Weeks (Q2W)|EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
1144177|NCT00450216|O1|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg
1144138|NCT00450333|O3|Outcome|Dynepo Once Every 2 Weeks (Q2W)|EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
1144139|NCT00450333|O2|Outcome|Dynepo-naive Twice-weekly (BIW)|EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
1144140|NCT00450333|O1|Outcome|Dynepo (Epoetin Delta)-Naive Once-weekly (QW)|Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
1144141|NCT00450333|E4|Reported Event|Dynepo QW|EPO stable subjects receiving Epoetin delta once weekly (QW)
1144142|NCT00450333|E3|Reported Event|Dynepo Once Every 2 Weeks (Q2W)|EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
1144143|NCT00450333|E2|Reported Event|Dynepo-naive Twice-weekly (BIW)|EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
1144144|NCT00450333|E1|Reported Event|Dynepo (Epoetin Delta)-Naive Once-weekly (QW)|Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
1144188|NCT00450112|B1|Baseline|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
1144145|NCT00450294|B1|Baseline|Longitudinal Group|This study is an observational longitudinal design. Ten patients were enrolled to determine what happens to eye pressure during surgery for abdominal aortic aneurysm repair. Therefore, all ten patients had intraocular pressure measurements made at different event intervals to determine if there was a change in intraocular pressure compared to their baseline intraocular pressure that was taken before surgery. No active intervention was performed to the patients based on intraocular pressure as clinicians were blinded to the intraocular pressure values.
1144146|NCT00450294|P1|Participant Flow|Longitudinal Study Group|This study is an OBSERVATIONAL STUDY. Ten patients were enrolled to determine what happens to eye pressure during surgery for abdominal aortic aneurysm repair. Therefore, all ten patients had intraocular pressure measurements made at different event intervals to determine if there was a change in intraocular pressure compared to their baseline intraocular pressure that was taken before surgery. No active intervention was performed to the patients based on intraocular pressure as clinicians were blinded to the intraocular pressure values.Measurement of Central venous pressure at event intervals during abdominal aortic aneurysm repair. Data are presented as mean +/- standard error.
1144147|NCT00450294|O1|Outcome|Longitudinal Study Group|This study is an observational longitudinal design. Ten patients were enrolled to determine what happens to eye pressure during surgery for abdominal aortic aneurysm repair.
1144148|NCT00450294|O1|Outcome|Longitudinal Group|This study is an OBSERVATIONAL STUDY. Ten patients were enrolled to determine what happens to eye pressure during surgery for abdominal aortic aneurysm repair. Therefore, all ten patients had intraocular pressure measurements made at different event intervals to determine if there was a change in intraocular pressure compared to their baseline intraocular pressure that was taken before surgery. No active intervention was performed to the patients based on intraocular pressure as clinicians were blinded to the intraocular pressure values.
1144149|NCT00450294|E1|Reported Event|Longitudinal Group|This study is an OBSERVATIONAL STUDY. Ten patients were enrolled to determine what happens to eye pressure during surgery for abdominal aortic aneurysm repair. Therefore, all ten patients had intraocular pressure measurements made at different event intervals to determine if there was a change in intraocular pressure compared to their baseline intraocular pressure that was taken before surgery. No active intervention was performed to the patients based on intraocular pressure as clinicians were blinded to the intraocular pressure values.
1144150|NCT00450255|B1|Baseline|Arm I|"Patients receive Aflibercept IV at 4 mg/kg over 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
1144151|NCT00450255|P1|Participant Flow|Arm I|"Patients receive Aflibercept IV at 4 mg/kg over 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
1144152|NCT00450255|O1|Outcome|Arm I|"Patients receive Aflibercept IV at 4 mg/kg 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
1144153|NCT00450255|O1|Outcome|Arm I|"Patients receive Aflibercept IV at 4 mg/kg over 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
1144154|NCT00450255|O1|Outcome|Arm I|"Patients receive Aflibercept IV at 4 mg/kg 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
1144155|NCT00450255|E1|Reported Event|Arm I|"Patients receive Aflibercept IV at 4 mg/kg over 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
1144156|NCT00450242|B3|Baseline|Total|Total of all reporting groups
1144157|NCT00450242|B2|Baseline|Placebo Cream|
1144158|NCT00450242|B1|Baseline|5% Lidocaine Cream|5% topical lidocaine cream.
1144159|NCT00450242|P2|Participant Flow|Placebo Cream|
1144160|NCT00450242|P1|Participant Flow|5% Lidocaine Cream|5% topical lidocaine cream.
1144161|NCT00450242|O2|Outcome|Placebo Cream|Topical cream vehicle.
1144162|NCT00450242|O1|Outcome|5% Lidocaine Cream|5% topical lidocaine cream.
1144163|NCT00450242|O2|Outcome|Placebo Cream|topical cream vehicle.
1144164|NCT00450242|O1|Outcome|5% Lidocaine Cream|5% topical lidocaine cream.
1144165|NCT00450242|O2|Outcome|Placebo Cream|
1144166|NCT00450242|O1|Outcome|5% Lidocaine Cream|5% topical lidocaine cream.
1144167|NCT00450242|O2|Outcome|Placebo Cream|Topical cream vehicle.
1144168|NCT00450242|O1|Outcome|5% Lidocaine Cream|5% topical lidocaine cream.
1144169|NCT00450242|E2|Reported Event|Placebo Cream|
1144170|NCT00450242|E1|Reported Event|5% Lidocaine Cream|5% topical lidocaine cream.
1144171|NCT00450216|B3|Baseline|Total|Total of all reporting groups
1144172|NCT00450216|B2|Baseline|Ibuprofen|Ibuprofen 800mg
1144173|NCT00450216|B1|Baseline|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg
1144174|NCT00450216|P2|Participant Flow|Ibuprofen|Ibuprofen 800mg tablets t.i.d.
1144175|NCT00450216|P1|Participant Flow|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg tablets t.i.d.
1144176|NCT00450216|O2|Outcome|Ibuprofen|Ibuprofen 800mg
1144179|NCT00450216|O1|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg
1144180|NCT00450216|O2|Outcome|Ibuprofen|Ibuprofen 800mg
1144181|NCT00450216|O1|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg
1144182|NCT00450216|O2|Outcome|Ibuprofen|Ibuprofen 800mg
1144183|NCT00450216|O1|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg
1144184|NCT00450216|E2|Reported Event|Ibuprofen|Ibuprofen 800mg
1144185|NCT00450216|E1|Reported Event|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg
1144186|NCT00450112|B3|Baseline|Total|Total of all reporting groups
1144187|NCT00450112|B2|Baseline|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
1144189|NCT00450112|P2|Participant Flow|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
1144190|NCT00450112|P1|Participant Flow|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
1144191|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
1144192|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
1144193|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
1144194|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
1144195|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
1144196|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
1144197|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
1144198|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
1144199|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
1144200|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
1144201|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
1144202|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
1144203|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
1144204|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
1144205|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
1144206|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
1144207|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
1144208|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
1144209|NCT00450112|E2|Reported Event|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
1144210|NCT00450112|E1|Reported Event|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
1144211|NCT00450073|B4|Baseline|Total|Total of all reporting groups
1144225|NCT00449956|B3|Baseline|Concomitant (Dorzolamide 1.0% / Timolol 0.5%)|Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
1144226|NCT00449956|B2|Baseline|Timolol 0.5%|Timolol 0.5%, one drop per dose twice daily to the study eye.
1144227|NCT00449956|B1|Baseline|MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)|MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
1144228|NCT00449956|P3|Participant Flow|Concomitant (Dorzolamide 1.0% / Timolol 0.5%)|Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
1144229|NCT00449956|P2|Participant Flow|Timolol 0.5%|Timolol 0.5%, one drop per dose twice daily to the study eye.
1144230|NCT00449956|P1|Participant Flow|MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)|MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
1144231|NCT00449956|O3|Outcome|Concomitant (Dorzolamide 1.0% / Timolol 0.5%)|Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
1144232|NCT00449956|O2|Outcome|Timolol 0.5%|Timolol 0.5%, one drop per dose twice daily to the study eye.
1144233|NCT00449956|O1|Outcome|MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)|MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
1144234|NCT00449956|O3|Outcome|Concomitant (Dorzolamide 1.0% / Timolol 0.5%)|Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
1144235|NCT00449956|O2|Outcome|Timolol 0.5%|Timolol 0.5%, one drop per dose twice daily to the study eye.
1144236|NCT00449956|O1|Outcome|MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)|MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
1144237|NCT00449956|O3|Outcome|Concomitant (Dorzolamide 1.0% / Timolol 0.5%)|Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
1144238|NCT00449956|O2|Outcome|Timolol 0.5%|Timolol 0.5%, one drop per dose twice daily to the study eye.
1144239|NCT00449956|O1|Outcome|MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)|MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
1144240|NCT00449956|E3|Reported Event|Concomitant (Dorzolamide 1.0% / Timolol 0.5%)|Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
1144241|NCT00449956|E2|Reported Event|Timolol 0.5%|Timolol 0.5%, one drop per dose twice daily to the study eye.
1144242|NCT00449956|E1|Reported Event|MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)|MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
1144243|NCT00449930|B3|Baseline|Total|Total of all reporting groups
1144244|NCT00449930|B2|Baseline|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
1144245|NCT00449930|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
1144246|NCT00449930|P2|Participant Flow|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
1144247|NCT00449930|P1|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
1144298|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
1144382|NCT00449176|E3|Reported Event|Placebo|Matching Placebo twice daily(BID)
1144248|NCT00449930|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
1144249|NCT00449930|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
1144250|NCT00449930|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
1144251|NCT00449930|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
1144252|NCT00449930|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
1144253|NCT00449930|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
1144254|NCT00449930|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
1144255|NCT00449930|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
1144256|NCT00449930|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
1144257|NCT00449930|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
1144593|NCT00448708|O2|Outcome|Lifespan® ePTFE Vascular Graft|Lifespan® ePTFE Vascular Graft Only
1144258|NCT00449930|E2|Reported Event|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
1144259|NCT00449930|E1|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
1144260|NCT00449865|B3|Baseline|Total|Total of all reporting groups
1144261|NCT00449865|B2|Baseline|Creatine|creatine 5 grams twice daily
1144262|NCT00449865|B1|Baseline|Placebo|placebo: an inactive substance
1144263|NCT00449865|P2|Participant Flow|Creatine|creatine monohydrate (10 gram /day)
1144264|NCT00449865|P1|Participant Flow|Placebo|placebo: an inactive substance
1144265|NCT00449865|O2|Outcome|Creatine|creatine monohydrate (10 grams/day)
1144266|NCT00449865|O1|Outcome|Placebo|placebo: an inactive substance
1144267|NCT00449865|E2|Reported Event|Creatine|creatine 5 grams twice daily
1144268|NCT00449865|E1|Reported Event|Placebo|placebo: an inactive substance
1144269|NCT00449787|B3|Baseline|Total|Total of all reporting groups
1144270|NCT00449787|B2|Baseline|Naproxen|Naproxen 500 mg tablet
1144271|NCT00449787|B1|Baseline|Sumatriptan|Sumatriptan 100 mg tablet
1144272|NCT00449787|P2|Participant Flow|Naproxen|Naproxen 500 mg tablet
1144273|NCT00449787|P1|Participant Flow|Sumatriptan|Sumatriptan 100 mg tablet
1144274|NCT00449787|O2|Outcome|Naproxen|Naproxen 500 mg tablet
1144275|NCT00449787|O1|Outcome|Sumatriptan|Sumatriptan 100 mg tablet
1144276|NCT00449787|O2|Outcome|Naproxen|Naproxen 500mg tablet
1144277|NCT00449787|O1|Outcome|Sumatriptan|Sumatriptan 100mg tablet
1144278|NCT00449787|O2|Outcome|Naproxen|Naproxen 500mg tablet
1144279|NCT00449787|O1|Outcome|Sumatriptan|Sumatriptan 100mg tablet
1144280|NCT00449787|E2|Reported Event|Naproxen|Naproxen 500 mg tablet
1144281|NCT00449787|E1|Reported Event|Sumatriptan|Sumatriptan 100 mg tablet
1144282|NCT00449748|B1|Baseline|RAD001|Oral RAD001 10 mg daily for 30 days
1144283|NCT00449748|P1|Participant Flow|RAD001|Oral RAD001 10 mg daily for 30 days
1144284|NCT00449748|O1|Outcome|RAD001|Oral RAD001 10 mg daily for 30 days
1144285|NCT00449748|E1|Reported Event|RAD001|Oral RAD001 10 mg daily for 30 days
1144286|NCT00449696|B3|Baseline|Total|Total of all reporting groups
1144287|NCT00449696|B2|Baseline|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
1144288|NCT00449696|B1|Baseline|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
1144289|NCT00449696|P2|Participant Flow|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
1144290|NCT00449696|P1|Participant Flow|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
1144291|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
1144292|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
1144293|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
1144294|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
1144295|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
1144296|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
1144297|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
1144299|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
1144300|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
1144301|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
1144302|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
1144303|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
1144304|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
1144305|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
1144306|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
1144307|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
1144308|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
1144309|NCT00449696|E2|Reported Event|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
1144310|NCT00449696|E1|Reported Event|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
1144311|NCT00449644|B5|Baseline|Total|Total of all reporting groups
1144312|NCT00449644|B4|Baseline|Placebo / BR (Stage 2)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 24.
1144313|NCT00449644|B3|Baseline|TMC207 / BR (Stage 2)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
1144314|NCT00449644|B2|Baseline|Placebo / BR (Stage 1)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
1144315|NCT00449644|B1|Baseline|TMC207 / BR (Stage 1)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 8.
1144316|NCT00449644|P4|Participant Flow|Placebo / BR (Stage 2)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 24.
1144317|NCT00449644|P3|Participant Flow|TMC207 / BR (Stage 2)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
1144318|NCT00449644|P2|Participant Flow|Placebo / BR (Stage 1)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
1144319|NCT00449644|P1|Participant Flow|TMC207 / BR (Stage 1)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 8.
1144320|NCT00449644|O2|Outcome|Placebo / BR (Stage 2)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
1144321|NCT00449644|O1|Outcome|TMC207 / BR (Stage 2)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times a week administered as 2 tablets, and BR. Only BR after Week 8.
1144322|NCT00449644|O2|Outcome|Placebo / BR (Stage 1)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week.
1144323|NCT00449644|O1|Outcome|TMC207 / BR (Stage 1)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times a week administered as 2 tablets, and BR. Only BR after Week 8.
1144324|NCT00449644|O2|Outcome|Placebo / BR (Stage 2)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
1144325|NCT00449644|O1|Outcome|TMC207 / BR (Stage 2)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
1144326|NCT00449644|O2|Outcome|Placebo / BR (Stage 1)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
1144327|NCT00449644|O1|Outcome|TMC207 / BR (Stage 1)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times a week administered as 2 tablets, and BR. Only BR after Week 8.
1144328|NCT00449644|O2|Outcome|Placebo / BR (Stage 2)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
1144380|NCT00449176|O2|Outcome|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
1144381|NCT00449176|O1|Outcome|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
1144329|NCT00449644|O1|Outcome|TMC207 / BR (Stage 2)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
1144330|NCT00449644|O2|Outcome|Placebo / BR (Stage 1)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
1144331|NCT00449644|O1|Outcome|TMC207 / BR (Stage 1)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times a week administered as 2 tablets, and BR. Only BR after Week 8.
1144332|NCT00449644|E4|Reported Event|Placebo / BR (Stage 2)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 24.
1144333|NCT00449644|E3|Reported Event|TMC207 / BR (Stage 2)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
1144334|NCT00449644|E2|Reported Event|Placebo / BR (Stage 1)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
1144335|NCT00449644|E1|Reported Event|TMC207 / BR (Stage 1)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 8.
1144336|NCT00449540|B3|Baseline|Total|Total of all reporting groups
1144337|NCT00449540|B2|Baseline|Sham TMS Device|Simulated Sham treatment without TMS
1144338|NCT00449540|B1|Baseline|Active Transcranial Magnetic Stimulation (TMS) Device|Active Transcranial Magnetic Stimulation Device Treatment
1144339|NCT00449540|P3|Participant Flow|Sham TMS Device|Device which does not deliver TMS pulse
1144341|NCT00449540|P1|Participant Flow|30 Day Lead in Phase|some particpants did not experience migrain in the 30 days allotted and therefore were not moved to the treatment phase
1144342|NCT00449540|O2|Outcome|Sham TMS Device|Simulated Sham treatment without TMS
1144343|NCT00449540|O1|Outcome|Active Transcranial Magnetic Stimulation (TMS) Device|Active Transcranial Magnetic Stimulation Device Treatment
1144344|NCT00449540|O2|Outcome|Sham TMS Device|Simulated Sham treatment without TMS
1144345|NCT00449540|O1|Outcome|Active Transcranial Magnetic Stimulation (TMS) Device|Active Transcranial Magnetic Stimulation Device Treatment
1144346|NCT00449540|O2|Outcome|Sham TMS Device|Simulated Sham treatment without TMS
1144347|NCT00449540|O1|Outcome|Active Transcranial Magnetic Stimulation (TMS) Device|Active Transcranial Magnetic Stimulation Device Treatment
1144348|NCT00449540|O2|Outcome|Sham TMS Device|Simulated Sham treatment without TMS
1144349|NCT00449540|O1|Outcome|Active Transcranial Magnetic Stimulation (TMS) Device|Active Transcranial Magnetic Stimulation Device Treatment
1144350|NCT00449540|E4|Reported Event|Sham TMS Device - Not Treatment Related|Sham TMS Device - events that are not treatment related
1144351|NCT00449540|E3|Reported Event|Active TMS - Not Treatment Related|Active Transcranial Magnetic Stimulation Device Treatment - Not treatment related
1144352|NCT00449540|E2|Reported Event|Sham TMS Device - Treatment Related|Simulated Sham treatment without TMS
1144353|NCT00449540|E1|Reported Event|Active TMS Device - Treatment Related|Active Transcranial Magnetic Stimulation Device Treatment - Treatment related
1144354|NCT00449176|B4|Baseline|Total|Total of all reporting groups
1144355|NCT00449176|B3|Baseline|Placebo|Matching Placebo twice daily(BID)
1144356|NCT00449176|B2|Baseline|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
1144357|NCT00449176|B1|Baseline|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
1144358|NCT00449176|P3|Participant Flow|Placebo|Matching Placebo twice daily(BID)
1144359|NCT00449176|P2|Participant Flow|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
1144360|NCT00449176|P1|Participant Flow|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
1144361|NCT00449176|O3|Outcome|Placebo|Matching Placebo twice daily(BID)
1144362|NCT00449176|O2|Outcome|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
1144363|NCT00449176|O1|Outcome|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
1144364|NCT00449176|O3|Outcome|Placebo|Matching Placebo twice daily(BID)
1144365|NCT00449176|O2|Outcome|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
1144366|NCT00449176|O1|Outcome|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
1144367|NCT00449176|O3|Outcome|Placebo|Matching Placebo twice daily(BID)
1144368|NCT00449176|O2|Outcome|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
1144369|NCT00449176|O1|Outcome|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
1144370|NCT00449176|O3|Outcome|Placebo|Matching Placebo twice daily(BID)
1144371|NCT00449176|O2|Outcome|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
1144372|NCT00449176|O1|Outcome|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
1144373|NCT00449176|O3|Outcome|Placebo|Matching Placebo twice daily(BID)
1144374|NCT00449176|O2|Outcome|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
1144375|NCT00449176|O1|Outcome|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
1144376|NCT00449176|O3|Outcome|Placebo|Matching Placebo twice daily(BID)
1144377|NCT00449176|O2|Outcome|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
1144378|NCT00449176|O1|Outcome|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
1144379|NCT00449176|O3|Outcome|Placebo|Matching Placebo twice daily(BID)
1144383|NCT00449176|E2|Reported Event|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
1144384|NCT00449176|E1|Reported Event|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
1144385|NCT00449163|B1|Baseline|Combination Chemotherapy and Bevacizumab|"Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:~Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;~Irinotecan: 110 mg/m^2 via IV infusion on Days 1, 8, 22, 29;~Leucovorin: 500 mg/m^2 via IV infusion on Days 1, 8, 22 and 29;~Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29."
1144386|NCT00449163|P1|Participant Flow|Combination Chemotherapy and Bevacizumab|"Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:~Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;~Irinotecan: 110 mg/m^2 via IV infusion on Days 1, 8, 22, 29;~Leucovorin: 500 mg/m^2 via IV infusion on Days 1, 8, 22 and 29;~Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29."
1144387|NCT00449163|O1|Outcome|Combination Chemotherapy and Bevacizumab|"Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:~Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;~Irinotecan: 110 mg/m^2 via IV infusion on Days 1, 8, 22, 29;~Leucovorin: 500 mg/m^2 via IV infusion on Days 1, 8, 22 and 29;~Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29."
1144388|NCT00449163|O1|Outcome|Combination Chemotherapy and Bevacizumab|"Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:~Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;~Irinotecan: 110 mg/m^2 via IV infusion on Days 1, 8, 22, 29;~Leucovorin: 500 mg/m^2 via IV infusion on Days 1, 8, 22 and 29;~Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29."
1144487|NCT00448916|P2|Participant Flow|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
1144389|NCT00449163|O1|Outcome|Combination Chemotherapy and Bevacizumab|"Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:~Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;~Irinotecan: 110 mg/m^2 via IV infusion on Days 1, 8, 22, 29;~Leucovorin: 500 mg/m^2 via IV infusion on Days 1, 8, 22 and 29;~Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29."
1144390|NCT00449163|O1|Outcome|Combination Chemotherapy and Bevacizumab|"Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:~Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;~Irinotecan: 110 mg/m^2 via IV infusion on Days 1, 8, 22, 29;~Leucovorin: 500 mg/m^2 via IV infusion on Days 1, 8, 22 and 29;~Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29."
1144391|NCT00449163|E1|Reported Event|Combination Chemotherapy and Bevacizumab|"Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:~Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;~Irinotecan: 110 mg/m^2 via IV infusion on Days 1, 8, 22, 29;~Leucovorin: 500 mg/m^2 via IV infusion on Days 1, 8, 22 and 29;~Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29."
1144392|NCT00449150|B4|Baseline|Total|Total of all reporting groups
1144393|NCT00449150|B3|Baseline|Placebo|Placebo on Week 0, 2 26 and 28
1144394|NCT00449150|B2|Baseline|Cetrorelix 78+52|78+52 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 52 mg combining Week 26 (52 mg) and Week 28 (0 mg)
1144395|NCT00449150|B1|Baseline|Cetrorelix 78+78|78+78 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
1144396|NCT00449150|P3|Participant Flow|Placebo|Placebo on Week 0, 2 26 and 28
1144397|NCT00449150|P2|Participant Flow|Cetrorelix 78+52|78+52 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 52 mg combining Week 26 (52 mg) and Week 28 (0 mg)
1144398|NCT00449150|P1|Participant Flow|Cetrorelix 78+78|78+78 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
1144399|NCT00449150|O3|Outcome|Placebo|Placebo on Week 0, 2 26 and 28
1144400|NCT00449150|O2|Outcome|Cetrorelix 78+52|78+52 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 52 mg combining Week 26 (52 mg) and Week 28 (0 mg)
1144401|NCT00449150|O1|Outcome|Cetrorelix 78+78|78+78 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
1144402|NCT00449150|E3|Reported Event|Placebo|Placebo on Week 0, 2 26 and 28
1144403|NCT00449150|E2|Reported Event|Cetrorelix 78+52|78+52 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 52 mg combining Week 26 (52 mg) and Week 28 (0 mg)
1144404|NCT00449150|E1|Reported Event|Cetrorelix 78+78|78+78 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
1144405|NCT00449072|B3|Baseline|Total|Total of all reporting groups
1144406|NCT00449072|B2|Baseline|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication"
1144407|NCT00449072|B1|Baseline|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication"
1144408|NCT00449072|P2|Participant Flow|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication"
1144409|NCT00449072|P1|Participant Flow|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication"
1144642|NCT00448630|E6|Reported Event|Amisulpride|amisulpride as prescribed by subject's physician
1144410|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
1144411|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
1144412|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
1144413|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
1144414|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
1144415|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
1144416|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
1144417|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
1144418|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
1144419|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
1144420|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
1144421|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
1144422|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
1144423|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
1144424|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
1144425|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
1144426|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
1144427|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
1144428|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
1144429|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
1144430|NCT00449072|E2|Reported Event|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication"
1144431|NCT00449072|E1|Reported Event|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication"
1144432|NCT00449046|B1|Baseline|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
1144433|NCT00449046|P1|Participant Flow|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
1144434|NCT00449046|O1|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
1144435|NCT00449046|O1|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
1144436|NCT00449046|O1|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
1144437|NCT00449046|O1|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
1144438|NCT00449046|O1|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
1144439|NCT00449046|O1|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
1144440|NCT00449046|O1|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
1144441|NCT00449046|O1|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
1144442|NCT00449046|E1|Reported Event|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
1144443|NCT00449033|B3|Baseline|Total|Total of all reporting groups
1144444|NCT00449033|B2|Baseline|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
1144445|NCT00449033|B1|Baseline|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
1144446|NCT00449033|P2|Participant Flow|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
1144447|NCT00449033|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
1144448|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
1144449|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
1144450|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
1144451|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
1144452|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
1144508|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
1144509|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
1144453|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
1144454|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
1144455|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
1144456|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
1144488|NCT00448916|P1|Participant Flow|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
1144457|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
1144458|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
1144459|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
1144460|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
1144461|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
1144462|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
1144463|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
1144464|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
1144465|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
1152964|NCT00428246|E2|Reported Event|2|2 mcg paricalcitol
1144466|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
1144467|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
1144468|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
1144469|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
1144470|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
1144471|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
1144472|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
1144473|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
1144474|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
1144475|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
1144476|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
1144477|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
1144478|NCT00449033|E2|Reported Event|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
1144636|NCT00448630|O4|Outcome|Olanzipine|olanzipine as prescribed by subject's physician
1144479|NCT00449033|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
1144480|NCT00448916|B5|Baseline|Total|Total of all reporting groups
1144481|NCT00448916|B4|Baseline|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
1144482|NCT00448916|B3|Baseline|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
1144483|NCT00448916|B2|Baseline|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
1144484|NCT00448916|B1|Baseline|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
1144485|NCT00448916|P4|Participant Flow|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
1144486|NCT00448916|P3|Participant Flow|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
1144489|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
1144490|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
1144491|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
1144492|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
1144493|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
1144494|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
1144495|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
1144496|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
1144497|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
1144498|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
1144499|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
1144500|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
1144501|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
1144502|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
1144503|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
1144504|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
1144505|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
1144506|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
1144507|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
1144637|NCT00448630|O3|Outcome|Quetiapine|quetiapine as prescribed by subject's physician
1144510|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
1144511|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
1144512|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
1144513|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
1144514|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
1144515|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
1144516|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
1144517|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
1144518|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
1144519|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
1144520|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
1144521|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
1144522|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
1144523|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
1144524|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
1144525|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
1144526|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
1144527|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
1144528|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
1144529|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
1144530|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
1144531|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
1144532|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
1144533|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
1144534|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
1144535|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
1144536|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
1144537|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
1144538|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
1144539|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
1144540|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
1144638|NCT00448630|O2|Outcome|Risperidone|risperidone as prescribed by subject's physician
1144541|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
1144542|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
1144543|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
1144544|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
1144545|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
1144546|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
1144547|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
1144548|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
1144549|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
1144550|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
1144551|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
1146352|NCT00444275|E4|Reported Event|Esomeprazole 20 mg on Demand (Maintenance Phase)|
1144552|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
1144553|NCT00448916|E5|Reported Event|Overall|This arm summarizes the AE data from all the treatment groups.
1144554|NCT00448916|E4|Reported Event|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
1144555|NCT00448916|E3|Reported Event|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
1144556|NCT00448916|E2|Reported Event|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
1144557|NCT00448916|E1|Reported Event|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
1144558|NCT00448864|B4|Baseline|Total|Total of all reporting groups
1144559|NCT00448864|B3|Baseline|Placebo|Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
1144560|NCT00448864|B2|Baseline|Ecallantide - High Dose Regimen|Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
1144561|NCT00448864|B1|Baseline|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
1144562|NCT00448864|P3|Participant Flow|Placebo|Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
1144563|NCT00448864|P2|Participant Flow|Ecallantide - High Dose Regimen|Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
1144564|NCT00448864|P1|Participant Flow|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 milligrams (mg) ecallantide in stages. Intravenous (IV) infusion of 0.6 milligrams per milliliter (mg/mL) ecallantide was administered at 2.92 milliliters per minute (mL/min) for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of cardiopulmonary bypass (CPB), whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 milliliters per hour (mL/hr) for 4 hours.
1144565|NCT00448864|O2|Outcome|Ecallantide - High Dose Regimen|Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
1144639|NCT00448630|O1|Outcome|Ziprasidone|ziprasidone as prescribed by subject's physician
1144566|NCT00448864|O1|Outcome|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 milligrams (mg) ecallantide in stages. Intravenous (IV) infusion of 0.6 milligrams per milliliter (mg/mL) ecallantide was administered at 2.92 milliliters per minute (mL/min) for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of cardiopulmonary bypass (CPB), whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
1144567|NCT00448864|O3|Outcome|Placebo|Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
1144568|NCT00448864|O2|Outcome|Ecallantide - High Dose Regimen|Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
1144569|NCT00448864|O1|Outcome|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
1144570|NCT00448864|O3|Outcome|Placebo|Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
1144571|NCT00448864|O2|Outcome|Ecallantide - High Dose Regimen|Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
1144588|NCT00448708|B1|Baseline|Vascular Wrap and Graft|Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
1146353|NCT00444275|E3|Reported Event|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
1144572|NCT00448864|O1|Outcome|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
1144573|NCT00448864|O3|Outcome|Placebo|Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
1144574|NCT00448864|O2|Outcome|Ecallantide - High Dose Regimen|Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
1144575|NCT00448864|O1|Outcome|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 mg ecallantide in stages. Intravenous (IV) infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
1144576|NCT00448864|E3|Reported Event|Placebo|Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
1144577|NCT00448864|E2|Reported Event|Ecallantide - High Dose Regimen|Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
1144578|NCT00448864|E1|Reported Event|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 milligrams (mg) ecallantide in stages. Intravenous (IV) infusion of 0.6 milligrams per milliliter (mg/mL) ecallantide was administered at 2.92 milliliters per minute (mL/min) for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of cardiopulmonary bypass (CPB), whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
1144579|NCT00448760|B1|Baseline|Single Arm|5-Fluorodeoxyuridine, Leucovorin, Oxaliplatin and Docetaxel
1144580|NCT00448760|P1|Participant Flow|Neoadjuvant + Adjuvant Chemotherapy|"Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles~Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles~Conventional surgery : Surgical removal of tumor for correlative studies~reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy~Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles~Microarray analysis : Analysis of tumor for pathologic response to protocol therapy~Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles"
1144581|NCT00448760|O1|Outcome|Single Arm|"Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles~Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles~Conventional surgery : Surgical removal of tumor for correlative studies~reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy~Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles~Microarray analysis : Analysis of tumor for pathologic response to protocol therapy~Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles"
1144640|NCT00448630|O1|Outcome|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
1144643|NCT00448630|E5|Reported Event|Aripiprazole|aripiprazole as prescribed by subject's physician
1144582|NCT00448760|O1|Outcome|Single Arm|"Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles~Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles~Conventional surgery : Surgical removal of tumor for correlative studies~reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy~Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles~Microarray analysis : Analysis of tumor for pathologic response to protocol therapy~Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles"
1144583|NCT00448760|O1|Outcome|Single Arm|"Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles~Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles~Conventional surgery : Surgical removal of tumor for correlative studies~reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy~Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles~Microarray analysis : Analysis of tumor for pathologic response to protocol therapy~Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles"
1144584|NCT00448760|O1|Outcome|Single Arm|"Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles~Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles~Conventional surgery : Surgical removal of tumor for correlative studies~reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy~Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles~Microarray analysis : Analysis of tumor for pathologic response to protocol therapy~Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles"
1144585|NCT00448760|E1|Reported Event|Single Arm|"Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles~Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles~Conventional surgery : Surgical removal of tumor for correlative studies~reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy~Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles~Microarray analysis : Analysis of tumor for pathologic response to protocol therapy~Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles"
1144586|NCT00448708|B3|Baseline|Total|Total of all reporting groups
1144587|NCT00448708|B2|Baseline|Lifespan® ePTFE Vascular Graft|Lifespan® ePTFE Vascular Graft Only
1144594|NCT00448708|O1|Outcome|Vascular Wrap and Graft|Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
1144595|NCT00448708|E2|Reported Event|Lifespan® ePTFE Vascular Graft|Lifespan® ePTFE Vascular Graft Only
1144596|NCT00448708|E1|Reported Event|Vascular Wrap and Graft|Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
1144597|NCT00448682|B1|Baseline|FUdR + Leucovorin + Oxaliplatin + Docetaxel|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered weekly, 3 out of 4 weeks, on days 1, 8 and 15:~Day 1 and Day 15 Chemotherapy Administration: Patients will be administered oxaliplatin (85 mg/m2) and docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110 mg/kg//500 mg/m2) on Day 1 and Day 15 of each cycle.~Day 8 Chemotherapy Administration On Day 8, treatment will consist of docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110mg/kg//500mg/m2).~There will be no treatment delivered week 4 (Day 22). For the purpose of this study, one cycle equals four weeks. There will be a maximum of 6 cycles."
1144598|NCT00448682|P1|Participant Flow|FUdR + Leucovorin + Oxaliplatin + Docetaxel|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered weekly, 3 out of 4 weeks, on days 1, 8 and 15:~Day 1 and Day 15 Chemotherapy Administration: Patients will be administered oxaliplatin (85 mg/m2) and docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110 mg/kg//500 mg/m2) on Day 1 and Day 15 of each cycle.~Day 8 Chemotherapy Administration On Day 8, treatment will consist of docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110mg/kg//500mg/m2).~There will be no treatment delivered week 4 (Day 22). For the purpose of this study, one cycle equals four weeks. There will be a maximum of 6 cycles."
1144599|NCT00448682|O1|Outcome|FUdR + Leucovorin + Oxaliplatin + Docetaxel|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered weekly, 3 out of 4 weeks, on days 1, 8 and 15:~Day 1 and Day 15 Chemotherapy Administration: Patients will be administered oxaliplatin (85 mg/m2) and docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110 mg/kg//500 mg/m2) on Day 1 and Day 15 of each cycle.~Day 8 Chemotherapy Administration On Day 8, treatment will consist of docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110mg/kg//500mg/m2).~There will be no treatment delivered week 4 (Day 22). For the purpose of this study, one cycle equals four weeks. There will be a maximum of 6 cycles."
1144600|NCT00448682|O1|Outcome|FUdR + Leucovorin + Oxaliplatin + Docetaxel|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered weekly, 3 out of 4 weeks, on days 1, 8 and 15:~Day 1 and Day 15 Chemotherapy Administration: Patients will be administered oxaliplatin (85 mg/m2) and docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110 mg/kg//500 mg/m2) on Day 1 and Day 15 of each cycle.~Day 8 Chemotherapy Administration On Day 8, treatment will consist of docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110mg/kg//500mg/m2).~There will be no treatment delivered week 4 (Day 22). For the purpose of this study, one cycle equals four weeks. There will be a maximum of 6 cycles."
1144601|NCT00448682|O1|Outcome|FUdR + Leucovorin + Oxaliplatin + Docetaxel|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered weekly, 3 out of 4 weeks, on days 1, 8 and 15:~Day 1 and Day 15 Chemotherapy Administration: Patients will be administered oxaliplatin (85 mg/m2) and docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110 mg/kg//500 mg/m2) on Day 1 and Day 15 of each cycle.~Day 8 Chemotherapy Administration On Day 8, treatment will consist of docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110mg/kg//500mg/m2).~There will be no treatment delivered week 4 (Day 22). For the purpose of this study, one cycle equals four weeks. There will be a maximum of 6 cycles."
1144641|NCT00448630|E7|Reported Event|Other|other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
1144602|NCT00448682|E1|Reported Event|FUdR + Leucovorin + Oxaliplatin + Docetaxel|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered weekly, 3 out of 4 weeks, on days 1, 8 and 15:~Day 1 and Day 15 Chemotherapy Administration: Patients will be administered oxaliplatin (85 mg/m2) and docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110 mg/kg//500 mg/m2) on Day 1 and Day 15 of each cycle.~Day 8 Chemotherapy Administration On Day 8, treatment will consist of docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110mg/kg//500mg/m2).~There will be no treatment delivered week 4 (Day 22). For the purpose of this study, one cycle equals four weeks. There will be a maximum of 6 cycles."
1144603|NCT00448630|B1|Baseline|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
1144604|NCT00448630|P1|Participant Flow|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
1144605|NCT00448630|O7|Outcome|Other|other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
1144606|NCT00448630|O6|Outcome|Amisulpride|amisulpride as prescribed by subject's physician
1144607|NCT00448630|O5|Outcome|Aripiprazole|aripiprazole as prescribed by subject's physician
1144608|NCT00448630|O4|Outcome|Olanzipine|olanzipine as prescribed by subject's physician
1144609|NCT00448630|O3|Outcome|Quetiapine|quetiapine as prescribed by subject's physician
1144610|NCT00448630|O2|Outcome|Risperidone|risperidone as prescribed by subject's physician
1144611|NCT00448630|O1|Outcome|Ziprasidone|ziprasidone as prescribed by subject's physician
1144612|NCT00448630|O7|Outcome|Other|other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
1144613|NCT00448630|O6|Outcome|Amisulpride|amisulpride as prescribed by subject's physician
1144614|NCT00448630|O5|Outcome|Aripiprazole|aripiprazole as prescribed by subject's physician
1144615|NCT00448630|O4|Outcome|Olanzipine|olanzipine as prescribed by subject's physician
1144616|NCT00448630|O3|Outcome|Quetiapine|quetiapine as prescribed by subject's physician
1144617|NCT00448630|O2|Outcome|Risperidone|risperidone as prescribed by subject's physician
1144618|NCT00448630|O1|Outcome|Ziprasidone|ziprasidone as prescribed by subject's physician
1144619|NCT00448630|O7|Outcome|Other|other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
1144620|NCT00448630|O6|Outcome|Amisulpride|amisulpride as prescribed by subject's physician
1144621|NCT00448630|O5|Outcome|Aripiprazole|aripiprazole as prescribed by subject's physician
1144622|NCT00448630|O4|Outcome|Olanzipine|olanzipine as prescribed by subject's physician
1144623|NCT00448630|O3|Outcome|Quetiapine|quetiapine as prescribed by subject's physician
1144624|NCT00448630|O2|Outcome|Risperidone|risperidone as prescribed by subject's physician
1144625|NCT00448630|O1|Outcome|Ziprasidone|ziprasidone as prescribed by subject's physician
1144626|NCT00448630|O1|Outcome|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
1144627|NCT00448630|O1|Outcome|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
1144628|NCT00448630|O1|Outcome|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
1144629|NCT00448630|O1|Outcome|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
1144630|NCT00448630|O1|Outcome|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
1144631|NCT00448630|O1|Outcome|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
1144632|NCT00448630|O1|Outcome|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
1144633|NCT00448630|O7|Outcome|Other|other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
1144634|NCT00448630|O6|Outcome|Amisulpride|amisulpride as prescribed by subject's physician
1144635|NCT00448630|O5|Outcome|Aripiprazole|aripiprazole as prescribed by subject's physician
1144644|NCT00448630|E4|Reported Event|Olanzipine|olanzipine as prescribed by subject's physician
1144645|NCT00448630|E3|Reported Event|Quetiapine|quetiapine as prescribed by subject's physician
1144646|NCT00448630|E2|Reported Event|Risperidone|risperidone as prescribed by subject's physician
1144647|NCT00448630|E1|Reported Event|Ziprasidone|ziprasidone as prescribed by subject's physician
1144648|NCT00448591|B1|Baseline|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on day 1 of each 3 week cycle, or 10 mg/kg iv on day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) until disease progression, unacceptable toxicity or withdrawal, along with Taxane-based chemotherapy as prescribed
1144649|NCT00448591|P1|Participant Flow|Bevacizumab|Participants received bevacizumab 15 milligrams per kilogram (mg/kg) intravenously (iv) on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) until disease progression, unacceptable toxicity or withdrawal, along with Taxane-based chemotherapy or in combination with other chemotherapy as prescribed.
1144650|NCT00448591|O1|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) along with Taxane-based chemotherapy as prescribed
1144651|NCT00448591|O1|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) along with Taxane-based chemotherapy as prescribed
1144652|NCT00448591|O1|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) until disease progression, unacceptable toxicity or withdrawal, along with Taxane-based chemotherapy as prescribed
1144653|NCT00448591|O1|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) along with Taxane-based chemotherapy as prescribed
1144654|NCT00448591|O1|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on day 1 of each 3 week cycle, or 10 mg/kg iv on day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) until disease progression, unacceptable toxicity or withdrawal, along with Taxane-based chemotherapy as prescribed
1144655|NCT00448591|O1|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) along with Taxane-based chemotherapy as prescribed
1144656|NCT00448591|E1|Reported Event|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) until disease progression, unacceptable toxicity or withdrawal, along with Taxane-based chemotherapy as prescribed
1144657|NCT00448539|B3|Baseline|Total|Total of all reporting groups
1144658|NCT00448539|B2|Baseline|Rufinamide (Placebo During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received placebo in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they transitioned from placebo to 3200 mg/day, beginning at 800mg/day. Upon starting the extension study, during the 12-18 day open-label Titration Phase, subjects receiving 2400–3200mg/day from the double-blind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800mg/day to 2400–3200mg/day. During the open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all participants; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
1144659|NCT00448539|B1|Baseline|Rufinamide (Rufinamide During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received rufinamide in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they maintained their 2400-3200mg/day dose. Upon starting the extension study, during the 12-18 day open-label Titration Phase, subjects receiving 2400–3200mg/day from the doubleblind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800mg/day to 2400–3200mg/day. During the open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all participants; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
1144660|NCT00448539|P2|Participant Flow|Rufinamide (Placebo During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received placebo in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they transitioned from placebo to 3200 mg/day, beginning at 800mg/day. Upon starting the extension study,during the 12-18 day open-label Titration Phase, subjects receiving 2400-3200mg/day from the double-blind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800mg/day to 2400-3200mg/day. During the open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all participants; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
1144661|NCT00448539|P1|Participant Flow|Rufinamide (Rufinamide During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received rufinamide in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they maintained their 2400-3200mg/day dose. Upon starting the extension study, during the 12-18 day open-label Titration Phase, subjects receiving 2400-3200mg/day from the doubleblind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800mg/day to 2400-3200mg/day. During the open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all participants; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
1144678|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
1144679|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
1145172|NCT00446641|P2|Participant Flow|Placebo|matching placebo to cilostazol
1144662|NCT00448539|O2|Outcome|Rufinamide (Placebo During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received placebo in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they transitioned from placebo to 3200 mg/day, beginning at 800mg/day. Upon starting the extension study, during the 12-18 day open-label Titration Phase, subjects receiving 2400–3200mg/day from the double-blind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800mg/day to 2400–3200mg/day. During the open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all participants; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
1144663|NCT00448539|O1|Outcome|Rufinamide (Rufinamide During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received rufinamide in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they maintained their 2400-3200mg/day dose. Upon starting the extension study, during the 12-18 day open-label Titration Phase, subjects receiving 2400–3200mg/day from the doubleblind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800mg/day to 2400–3200mg/day. During the open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all participants; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
1144664|NCT00448539|E2|Reported Event|Rufinamide (Placebo During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received placebo in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they transitioned from placebo to 3200 mg/day, beginning at 800mg/day. Upon starting the extension study,during the 12-18 day open-label Titration Phase, subjects receiving 2400–3200mg/day from the double-blind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800mg/day to 2400–3200mg/day. During the open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all participants; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
1144692|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
1144693|NCT00448435|O2|Outcome|SLM 50mcg + FP 100 Mcg/Day|Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg + FP (Fluticasone Propionate) DPI 50 mcg twice daily
1144694|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
1144665|NCT00448539|E1|Reported Event|Rufinamide (Rufinamide During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received rufinamide in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they maintained their 2400-3200mg/day dose. Upon starting the extension study, during the 12-18 day open-label Titration Phase, subjects receiving 2400–3200mg/day from the doubleblind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800mg/day to 2400–3200mg/day. During the open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all participants; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
1144666|NCT00448448|B3|Baseline|Total|Total of all reporting groups
1144667|NCT00448448|B2|Baseline|Observation|Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.
1144668|NCT00448448|B1|Baseline|Brace|"This study involves full-time, rigid TLSO's only. Braced subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.~Brace: Brace (TLSO) prescribed for at least 18 hours per day. Wear time measured using a temperature monitor. Orthotic evaluations are conducted every 6 months and as necessary to maintain brace fit and function."
1144669|NCT00448448|P2|Participant Flow|Observation|"Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.~Observation: Clinical, radiographic, and self-report follow-up every 6 months."
1144670|NCT00448448|P1|Participant Flow|Brace|"This study involves full-time, rigid TLSO's only. Braced subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning. Orthotic evaluations are conducted every 6 months as as necessary to maintain brace fit and function.~Brace: Brace (TLSO) applied for at least 18 hours per day. Wear time measured using a temperature monitor. Clinical, radiographic, and self-report follow-up every 6 months."
1144671|NCT00448448|O2|Outcome|Observation|"Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.~Observation: Clinical, radiographic, and self-report follow-up every 6 months."
1144672|NCT00448448|O1|Outcome|Brace|"This study involves full-time, rigid TLSO's only. Braced subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning. Orthotic evaluations are conducted every 6 months as as necessary to maintain brace fit and function.~Brace: Brace (TLSO) applied for at least 18 hours per day. Wear time measured using a temperature monitor. Clinical, radiographic, and self-report follow-up every 6 months."
1144673|NCT00448448|E2|Reported Event|Observation|"Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.~Observation: Clinical, radiographic, and self-report follow-up every 6 months."
1144674|NCT00448448|E1|Reported Event|Brace|"This study involves full-time, rigid TLSO's only. Braced subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning. Orthotic evaluations are conducted every 6 months as as necessary to maintain brace fit and function.~Brace: Brace (TLSO) applied for at least 18 hours per day. Wear time measured using a temperature monitor. Clinical, radiographic, and self-report follow-up every 6 months."
1144675|NCT00448435|B1|Baseline|Overall Study Population|Randomized Population
1144676|NCT00448435|P2|Participant Flow|SLM 50 Mcg + FP 100 Mcg/Day First|SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg + FP (Fluticasone Propionate) DPI 50 mcg twice daily in first intervention period and GW815SF (SFC; Salmeterol/Fluticasone Propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily in second intervention period (after washout period).
1144677|NCT00448435|P1|Participant Flow|SFC 50/100 Mcg/Day First|GW815SF (SFC; Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily in first intervention period and SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg + FP (Fluticasone Propionate) DPI 50 mcg twice daily in second intervention period (after washout period).
1144680|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
1144681|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
1144682|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
1144683|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
1144684|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
1144685|NCT00448435|O2|Outcome|SLM 50 Mcg + FP 100 Mcg/Day|Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
1144686|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
1144687|NCT00448435|O2|Outcome|SLM 50 Mcg + FP 100 Mcg/Day|Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
1144688|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
1144689|NCT00448435|O2|Outcome|SLM 50 Mcg + FP 100 Mcg/Day|Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
1144690|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
1144691|NCT00448435|O2|Outcome|SLM 50 Mcg + FP 100 Mcg/Day|Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
1144695|NCT00448435|O2|Outcome|SLM 50 Mcg + FP 100 Mcg/Day|Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
1144696|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
1144697|NCT00448435|O2|Outcome|SLM 50 Mcg + FP 100 Mcg/Day|Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
1144698|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
1144699|NCT00448435|E3|Reported Event|SFC 50/100mcg/Day (Extension Period)|Safety Population who switched to Extension Period and received GW815SF HFA MDI 25/50mcg twice daily during the Extension period
1144700|NCT00448435|E2|Reported Event|SLM 50 + FP 100 Mcg/Day|Safety Population who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily in Crossover Period Weeks 1-4 and 7-10
1144701|NCT00448435|E1|Reported Event|SFC 50/100 Mcg/Day|Safety Population who received GW815SF (SFC, Salmeterol/Fluticasone Propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily in Crossover Period Weeks 1-4 and 7-10
1144702|NCT00448344|B3|Baseline|Total|Total of all reporting groups
1144703|NCT00448344|B2|Baseline|Arm 2|"Standard smoking cessation~Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions"
1144704|NCT00448344|B1|Baseline|Arm 1|"Family-supported smoking cessation~Family-supported: Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking"
1144705|NCT00448344|P2|Participant Flow|Standard Smoking Cessation|"Standard smoking cessation~Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions"
1144706|NCT00448344|P1|Participant Flow|Family-supported Smoking Cessation|"Family-supported smoking cessation~Family-supported: Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking"
1144707|NCT00448344|O2|Outcome|Arm 2|"Standard smoking cessation~Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions"
1144708|NCT00448344|O1|Outcome|Arm 1|"Family-supported smoking cessation~Family-supported: Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking"
1144709|NCT00448344|O2|Outcome|Arm 2|"Standard smoking cessation~Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions"
1144710|NCT00448344|O1|Outcome|Arm 1|"Family-supported smoking cessation~Family-supported: Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking"
1144711|NCT00448344|E2|Reported Event|Arm 2|"Standard smoking cessation~Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions"
1152965|NCT00428246|E1|Reported Event|1|1 mcg paricalcitol
1144712|NCT00448344|E1|Reported Event|Arm 1|"Family-supported smoking cessation~Family-supported: Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking"
1144713|NCT00448279|B3|Baseline|Total|Total of all reporting groups
1144714|NCT00448279|B2|Baseline|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
1144715|NCT00448279|B1|Baseline|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
1144716|NCT00448279|P2|Participant Flow|Chemotherapy Plus (+) Trastuzumab|Participants received trastuzumab at either 2 milligrams per kilogram (mg/kg), intravenously (IV), every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
1144717|NCT00448279|P1|Participant Flow|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
1144718|NCT00448279|O2|Outcome|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
1144719|NCT00448279|O1|Outcome|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
1144720|NCT00448279|O2|Outcome|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
1144721|NCT00448279|O1|Outcome|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
1144722|NCT00448279|O2|Outcome|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
1144723|NCT00448279|O1|Outcome|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
1144724|NCT00448279|O2|Outcome|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
1144725|NCT00448279|O1|Outcome|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
1144726|NCT00448279|O2|Outcome|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
1144727|NCT00448279|O1|Outcome|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
1144755|NCT00448227|O3|Outcome|Famciclovir: Infants 6 to 12 Months|Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
1145173|NCT00446641|P1|Participant Flow|Cilostazol|Cilostazol 100mg twice per day
1144728|NCT00448279|O2|Outcome|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
1144729|NCT00448279|O1|Outcome|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
1144730|NCT00448279|E2|Reported Event|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
1144731|NCT00448279|E1|Reported Event|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
1144732|NCT00448227|B1|Baseline|Famciclovir|Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
1144733|NCT00448227|P1|Participant Flow|Famciclovir|Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
1144734|NCT00448227|O4|Outcome|Total|
1144735|NCT00448227|O3|Outcome|Famciclovir: Infants 6 to 12 Months|Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
1144736|NCT00448227|O2|Outcome|Famciclovir: Infants 3 to <6 Months|Infants 3 to <6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
1144737|NCT00448227|O1|Outcome|Famciclovir: Infants 1 to <3 Months|Infants 1 to <3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
1149027|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
1144738|NCT00448227|O3|Outcome|Famciclovir: Infants 6 to 12 Months|Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
1144739|NCT00448227|O2|Outcome|Famciclovir: Infants 3 to <6 Months|Infants 3 to <6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
1144740|NCT00448227|O1|Outcome|Famciclovir: Infants 1 to <3 Months|Infants 1 to <3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
1144741|NCT00448227|O3|Outcome|Famciclovir: Infants 6 to 12 Months|Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
1144742|NCT00448227|O2|Outcome|Famciclovir: Infants 3 to <6 Months|Infants 3 to <6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
1144743|NCT00448227|O1|Outcome|Famciclovir: Infants 1 to <3 Months|Infants 1 to <3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
1144744|NCT00448227|O3|Outcome|Famciclovir: Infants 6 to 12 Months|Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
1144745|NCT00448227|O2|Outcome|Famciclovir: Infants 3 to <6 Months|Infants 3 to <6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
1144746|NCT00448227|O1|Outcome|Famciclovir: Infants 1 to <3 Months|Infants 1 to <3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
1144747|NCT00448227|O4|Outcome|Total|
1144748|NCT00448227|O3|Outcome|Famciclovir: Infants 6 to 12 Months|Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
1144749|NCT00448227|O2|Outcome|Famciclovir: Infants 3 to <6 Months|Infants 3 to <6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
1144750|NCT00448227|O1|Outcome|Famciclovir: Infants 1 to <3 Months|Infants 1 to <3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
1144751|NCT00448227|O4|Outcome|Total|
1144752|NCT00448227|O3|Outcome|Famciclovir: Infants 6 to 12 Months|Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
1144753|NCT00448227|O2|Outcome|Famciclovir: Infants 3 to <6 Months|Infants 3 to <6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
1144754|NCT00448227|O1|Outcome|Famciclovir: Infants 1 to <3 Months|Infants 1 to <3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
1144871|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
1145174|NCT00446641|O2|Outcome|Placebo|matching placebo to cilostazol
1144756|NCT00448227|O2|Outcome|Famciclovir: Infants 3 to <6 Months|Infants 3 to <6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
1144757|NCT00448227|O1|Outcome|Famciclovir: Infants 1 to <3 Months|Infants 1 to <3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
1144758|NCT00448227|E1|Reported Event|Famciclovir|Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
1144759|NCT00448201|B1|Baseline|All Trial Participants|All patients received IV fludarabine 30 mg/m2/day on days -7 through -3; busulfan 6.4 mg/kg by continuous infusion over 48 hours on days -6 through -5 and tacrolimus from day -1. Throughout the study duration, 8 different GVHD regimens were investigated. In addition to tacrolimus, patients received combinations of 3 agents: methotrexate (5 mg/m2 D1, 3, 6), rabbit antithymocyte globulin (ATG, 3 mg/kg to- 6 mg/kg) or alemtuzumab (Campath, 30 mg to- 90 mg).
1144760|NCT00448201|P1|Participant Flow|All Trial Participants|All patients received IV fludarabine 30 mg/m2/day on days -7 through -3; busulfan 6.4 mg/kg by continuous infusion over 48 hours on days -6 through -5 and tacrolimus from day -1. Throughout the study duration, 8 different GVHD regimens were investigated. In addition to tacrolimus, patients received combinations of 3 agents: methotrexate (5 mg/m2 D1, 3, 6), rabbit antithymocyte globulin (ATG, 3 mg/kg to- 6 mg/kg) or alemtuzumab (Campath, 30 mg to- 90 mg).
1144761|NCT00448201|O1|Outcome|All Trial Participants|All patients received IV fludarabine 30 mg/m2/day on days -7 through -3; busulfan 6.4 mg/kg by continuous infusion over 48 hours on days -6 through -5 and tacrolimus from day -1. Throughout the study duration, 8 different GVHD regimens were investigated. In addition to tacrolimus, patients received combinations of 3 agents: methotrexate (5 mg/m2 D1, 3, 6), rabbit antithymocyte globulin (ATG, 3 mg/kg to- 6 mg/kg) or alemtuzumab (Campath, 30 mg to- 90 mg).
1144762|NCT00448201|O1|Outcome|All Trial Participants|All patients received IV fludarabine 30 mg/m2/day on days -7 through -3; busulfan 6.4 mg/kg by continuous infusion over 48 hours on days -6 through -5 and tacrolimus from day -1. Throughout the study duration, 8 different GVHD regimens were investigated. In addition to tacrolimus, patients received combinations of 3 agents: methotrexate (5 mg/m2 D1, 3, 6), rabbit antithymocyte globulin (ATG, 3 mg/kg to- 6 mg/kg) or alemtuzumab (Campath, 30 mg to- 90 mg).
1144763|NCT00448201|O2|Outcome|Day 90|90 days post-transplant
1144764|NCT00448201|O1|Outcome|Day 60|60 days post-transplant
1144788|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
1144765|NCT00448201|O1|Outcome|All Trial Participants|All patients received IV fludarabine 30 mg/m2/day on days -7 through -3; busulfan 6.4 mg/kg by continuous infusion over 48 hours on days -6 through -5 and tacrolimus from day -1. Throughout the study duration, 8 different GVHD regimens were investigated. In addition to tacrolimus, patients received combinations of 3 agents: methotrexate (5 mg/m2 D1, 3, 6), rabbit antithymocyte globulin (ATG, 3 mg/kg to- 6 mg/kg) or alemtuzumab (Campath, 30 mg to- 90 mg).
1144766|NCT00448201|O1|Outcome|All Trial Participants|All patients received IV fludarabine 30 mg/m2/day on days -7 through -3; busulfan 6.4 mg/kg by continuous infusion over 48 hours on days -6 through -5 and tacrolimus from day -1. Throughout the study duration, 8 different GVHD regimens were investigated. In addition to tacrolimus, patients received combinations of 3 agents: methotrexate (5 mg/m2 D1, 3, 6), rabbit antithymocyte globulin (ATG, 3 mg/kg to- 6 mg/kg) or alemtuzumab (Campath, 30 mg to- 90 mg).
1144767|NCT00448201|E1|Reported Event|All Trial Participants|All patients received IV fludarabine 30 mg/m2/day on days -7 through -3; busulfan 6.4 mg/kg by continuous infusion over 48 hours on days -6 through -5 and tacrolimus from day -1. Throughout the study duration, 8 different GVHD regimens were investigated. In addition to tacrolimus, patients received combinations of 3 agents: methotrexate (5 mg/m2 D1, 3, 6), rabbit antithymocyte globulin (ATG, 3 mg/kg to- 6 mg/kg) or alemtuzumab (Campath, 30 mg to- 90 mg).
1144768|NCT00448175|B3|Baseline|Total|Total of all reporting groups
1144769|NCT00448175|B2|Baseline|4mg Daily Tolterodine|90 day prescription for 4mg daily extended-release tolterodine tartrate (Detrol LA)
1144770|NCT00448175|B1|Baseline|Urgent PC Treatment Arm|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
1144771|NCT00448175|P2|Participant Flow|4mg Daily Tolterodine|90 day prescription for 4mg daily extended-release tolterodine tartrate (Detrol LA)
1144772|NCT00448175|P1|Participant Flow|Urgent PC Treatment Arm|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
1144773|NCT00448175|O2|Outcome|4mg Daily Tolterodine|90 day prescription for 4mg daily extended-release tolterodine tartrate (Detrol LA)
1144774|NCT00448175|O1|Outcome|Urgent PC Treatment Arm|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
1144775|NCT00448175|E2|Reported Event|4mg Daily Tolterodine|90 day prescription for 4mg daily extended-release tolterodine tartrate (Detrol LA)
1144776|NCT00448175|E1|Reported Event|Urgent PC Treatment Arm|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
1144777|NCT00448136|B3|Baseline|Total|Total of all reporting groups
1144778|NCT00448136|B2|Baseline|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
1144779|NCT00448136|B1|Baseline|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
1145175|NCT00446641|O1|Outcome|Cilostazol|Cilostazol 100mg twice per day
1145176|NCT00446641|O2|Outcome|Placebo|matching placebo to cilostazol
1144780|NCT00448136|P2|Participant Flow|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, orally (PO), twice daily (BID) on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
1144781|NCT00448136|P1|Participant Flow|Bevacizumab + 5-fluorouracil (5-FU) + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenously (IV) on Days 1 and 22; 5-FU 400 mg per square meter per day (mg/m^2/day) IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
1144782|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
1144783|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
1144784|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
1144785|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
1144786|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
1144787|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
1145032|NCT00447226|O1|Outcome|All Screened Participants|All screened participants
1145033|NCT00447226|O1|Outcome|Screened Participants With Gastric Cancer|Screened participants with gastric cancer
1144789|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
1144790|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
1144791|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
1144792|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
1144793|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
1144794|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
1144795|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
1144796|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
1144797|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
1144798|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
1144799|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
1144800|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
1144801|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
1144872|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
1144802|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
1144803|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
1144804|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
1144805|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
1144806|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
1144807|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
1144808|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
1144809|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
1144810|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
1146354|NCT00444275|E2|Reported Event|Esomeprazole 40 mg Once Daily (Initial Phase)|
1144811|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
1144812|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
1144813|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
1144814|NCT00448136|E2|Reported Event|Bevacizumab + Capecitabine|Cycles 1-9 (21-Day cycle): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 2000 mg/m^2 tablets PO in a divided dose every 12 hours within 30 minutes following a meal, on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
1144815|NCT00448136|E1|Reported Event|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
1144816|NCT00448123|B3|Baseline|Total|Total of all reporting groups
1144817|NCT00448123|B2|Baseline|Tamsulosin|"Intervention - Tamsulosin~Tamsulosin: Study Drug"
1144818|NCT00448123|B1|Baseline|Placebo|Placebo Group
1144819|NCT00448123|P2|Participant Flow|Tamsulosin|Tamsulosin orally 0.4 mg/daily for up to 10 days.
1144820|NCT00448123|P1|Participant Flow|Placebo|None active placebo orally per day for up to 10 days.
1144821|NCT00448123|O2|Outcome|Tamsulosin|"Intervention - Tamsulosin~Tamsulosin: Study Drug"
1144822|NCT00448123|O1|Outcome|Placebo|"Placebo~Placebo: Placebo"
1144823|NCT00448123|O2|Outcome|Tamsulosin|Tamsulosin orally 0.4 mg/daily for up to 10 days.
1144824|NCT00448123|O1|Outcome|Placebo|Active placebo orally per day for up to 10 days.
1144825|NCT00448123|O2|Outcome|Tamsulosin|"Intervention - Tamsulosin~Tamsulosin: Study Drug"
1144826|NCT00448123|O1|Outcome|Placebo|Placebo Group
1144827|NCT00448123|E2|Reported Event|Tamsulosin|"Intervention - Tamsulosin~Tamsulosin: Study Drug"
1144828|NCT00448123|E1|Reported Event|Placebo|Placebo Group
1144829|NCT00448019|B1|Baseline|FCR + Bevacizumab|FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
1144830|NCT00448019|P1|Participant Flow|FCR + Bevacizumab|FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
1144831|NCT00448019|O1|Outcome|FCR + Bevacizumab|FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
1144832|NCT00448019|O1|Outcome|FCR + Bevacizumab|FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
1144833|NCT00448019|O1|Outcome|FCR + Bevacizumab|FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
1144873|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
1145177|NCT00446641|O1|Outcome|Cilostazol|Cilostazol 100mg twice per day
1144834|NCT00448019|E1|Reported Event|FCR + Bevacizumab|FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
1144835|NCT00447902|B3|Baseline|Total|Total of all reporting groups
1144836|NCT00447902|B2|Baseline|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
1144837|NCT00447902|B1|Baseline|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
1144838|NCT00447902|P2|Participant Flow|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
1144839|NCT00447902|P1|Participant Flow|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
1144840|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
1144841|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
1144842|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
1144843|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
1144844|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
1144845|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
1144846|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
1144847|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
1146355|NCT00444275|E1|Reported Event|Esomeprazole 20 mg Once Daily (Initial Phase)|
1144848|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
1144849|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
1144850|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
1144851|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
1144852|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
1144853|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
1144854|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
1144855|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
1144856|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
1144857|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
1144858|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
1144859|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
1144860|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
1144861|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
1144862|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
1144863|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
1144864|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
1144865|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
1144866|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
1144867|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
1144868|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
1144869|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
1144870|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
1145178|NCT00446641|O2|Outcome|Placebo|matching placebo to cilostazol
1144874|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
1144875|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
1144876|NCT00447902|E2|Reported Event|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
1144877|NCT00447902|E1|Reported Event|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
1144878|NCT00447603|B1|Baseline|All Enrolled|Participants who met initial screening criteria for inclusion in study and were enrolled in the study.
1144879|NCT00447603|P3|Participant Flow|Losartan 50 Mg-100 mg (Filter Period)|Participants >=50 kg; Administered Losartan 50mg, oral, once daily for 3 weeks, then Losartan 100 mg for 3 weeks
1144880|NCT00447603|P2|Participant Flow|Losartan 25 Mg-50 mg (Filter Period)|Participants <50 kg; Administered Losartan 25 mg, oral, once daily for 3 weeks, then Losartan 50 mg for 3 weeks
1144881|NCT00447603|P1|Participant Flow|All Enrolled|Participants who met initial screening criteria for inclusion in study and were enrolled in the study.
1144882|NCT00447603|O4|Outcome|Losartan 100 mg/HCTZ 12.5 mg|Losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg once daily for 4 weeks
1144883|NCT00447603|O3|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg once daily for 4 weeks
1144884|NCT00447603|O2|Outcome|Losartan 100 mg|Losartan 100 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
1144885|NCT00447603|O1|Outcome|Losartan 50 mg|Losartan 50 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
1144886|NCT00447603|O4|Outcome|Losartan 100 mg/HCTZ 12.5 mg|Losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg once daily for 4 weeks
1144887|NCT00447603|O3|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg once daily for 4 weeks
1144888|NCT00447603|O2|Outcome|Losartan 100 mg|Losartan 100 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
1144889|NCT00447603|O1|Outcome|Losartan 50 mg|Losartan 50 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
1144890|NCT00447603|O4|Outcome|Losartan 100 mg/HCTZ 12.5 mg|Losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg once daily for 4 weeks
1144891|NCT00447603|O3|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg once daily for 4 weeks
1144892|NCT00447603|O2|Outcome|Losartan 100 mg|Losartan 100 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
1144893|NCT00447603|O1|Outcome|Losartan 50 mg|Losartan 50 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
1144894|NCT00447603|O4|Outcome|Losartan 100 mg/HCTZ 12.5 mg|Losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg once daily for 4 weeks
1144895|NCT00447603|O3|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg once daily for 4 weeks
1144896|NCT00447603|O2|Outcome|Losartan 100 mg|Losartan 100 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
1144897|NCT00447603|O1|Outcome|Losartan 50 mg|Losartan 50 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
1144898|NCT00447603|E2|Reported Event|Losartan 50 Mg-100 mg (Filter Period)|Participants >=50 kg; Administered Losartan 50mg, oral, once daily for 3 weeks, then Losartan 100 mg for 3 weeks
1144899|NCT00447603|E1|Reported Event|Losartan 25 Mg-50 mg (Filter Period)|Participants <50 kg; Administered Losartan 25 mg, oral, once daily for 3 weeks, then Losartan 50 mg for 3 weeks
1144900|NCT00447590|B1|Baseline|LAP-BAND|All subjects who received the LAP-BAND System.
1144901|NCT00447590|P1|Participant Flow|LAP-BAND|All subjects who received the LAP-BAND System.
1144902|NCT00447590|O1|Outcome|LAP-BAND|All subjects who received the LAP-BAND System.
1144903|NCT00447590|O1|Outcome|LAP-BAND|All subjects who received the LAP-BAND System.
1144904|NCT00447590|O1|Outcome|LAP-BAND|All subjects who received the LAP-BAND System.
1144905|NCT00447590|O1|Outcome|LAP-BAND|All subjects who received the LAP-BAND System.
1144906|NCT00447590|O1|Outcome|LAP-BAND|All subjects who received the LAP-BAND System.
1144907|NCT00447590|O1|Outcome|LAP-BAND|All subjects who received the LAP-BAND System.
1144908|NCT00447590|E1|Reported Event|LAP-BAND|All subjects who received the LAP-BAND System.
1144909|NCT00447499|B1|Baseline|Somatuline Autogel (Lanreotide Acetate) Injection|Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
1144910|NCT00447499|P1|Participant Flow|Somatuline Autogel (Lanreotide Acetate) Injection|Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
1144911|NCT00447499|O1|Outcome|Somatuline Autogel (Lanreotide Acetate) Injection|Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
1145179|NCT00446641|O1|Outcome|Cilostazol|Cilostazol 100mg twice per day
1144912|NCT00447499|O1|Outcome|Somatuline Autogel (Lanreotide Acetate) Injection|Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
1144913|NCT00447499|O1|Outcome|Somatuline Autogel (Lanreotide Acetate) Injection|Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
1144914|NCT00447499|O1|Outcome|Somatuline Autogel (Lanreotide Acetate)|Somatuline Autogel (lanreotide acetate) Injection/Switch Patient
1144915|NCT00447499|O1|Outcome|Somatuline Autogel (Lanreotide Acetate)/Switch Patient|
1144916|NCT00447499|O1|Outcome|Somatuline Autogel (Lanreotide Acetate)/Switch Patient|
1144917|NCT00447499|O1|Outcome|Somatuline Autogel (Lanreotide Acetate) Injection|Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
1144918|NCT00447499|E1|Reported Event|Somatuline Autogel (Lanreotide Acetate) Injection|Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
1144919|NCT00447421|B1|Baseline|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
1144920|NCT00447421|P1|Participant Flow|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
1144921|NCT00447421|O1|Outcome|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
1144922|NCT00447421|O1|Outcome|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
1144923|NCT00447421|O1|Outcome|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
1144924|NCT00447421|O1|Outcome|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
1144925|NCT00447421|O1|Outcome|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
1144926|NCT00447421|O1|Outcome|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
1144927|NCT00447421|O1|Outcome|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
1144928|NCT00447421|E1|Reported Event|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
1144929|NCT00447382|B3|Baseline|Total|Total of all reporting groups
1144930|NCT00447382|B2|Baseline|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144931|NCT00447382|B1|Baseline|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144932|NCT00447382|P2|Participant Flow|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144933|NCT00447382|P1|Participant Flow|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144934|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144935|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144936|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1145013|NCT00447278|E2|Reported Event|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
1144937|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144938|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144939|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144940|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144941|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144942|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144943|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144944|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144945|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1145337|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
1144946|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144947|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144948|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144949|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144950|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144951|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144952|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144953|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144954|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144955|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144956|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144957|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144958|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144959|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144960|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144961|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144962|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1145180|NCT00446641|O2|Outcome|Placebo|matching placebo to cilostazol
1144963|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144964|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144965|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144966|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144967|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144968|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144969|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144970|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144971|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144972|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144973|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144974|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144975|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144976|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144977|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144978|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144979|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144980|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144981|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144982|NCT00447382|E2|Reported Event|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144983|NCT00447382|E1|Reported Event|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
1144984|NCT00447330|B1|Baseline|1- Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avastin|"capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.~Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.~Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
1144985|NCT00447330|P1|Participant Flow|1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti|"capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.~Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.~Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
1145014|NCT00447278|E1|Reported Event|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
1145181|NCT00446641|O1|Outcome|Cilostazol|Cilostazol 100mg twice per day
1144986|NCT00447330|O1|Outcome|1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti|"capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.~Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.~Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
1144987|NCT00447330|O1|Outcome|1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti|"capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.~Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.~Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
1144988|NCT00447330|O1|Outcome|1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti|"capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.~Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.~Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
1144989|NCT00447330|O1|Outcome|1- Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avastin|"capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.~Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.~Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
1146436|NCT00443820|B4|Baseline|Vehicle 48 Weeks|Vehicle (placebo) for 48 weeks
1144990|NCT00447330|E1|Reported Event|1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti|"capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.~Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.~Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
1144991|NCT00447278|B3|Baseline|Total|Total of all reporting groups
1144992|NCT00447278|B2|Baseline|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
1144993|NCT00447278|B1|Baseline|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
1144994|NCT00447278|P2|Participant Flow|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
1144995|NCT00447278|P1|Participant Flow|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
1144996|NCT00447278|O1|Outcome|Pearson Correlation Coefficient|Correlation Coefficient between parent-rated and patient-rated CHIP T-score domains.
1144997|NCT00447278|O2|Outcome|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
1144998|NCT00447278|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
1144999|NCT00447278|O2|Outcome|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
1145000|NCT00447278|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
1145001|NCT00447278|O2|Outcome|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
1145002|NCT00447278|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
1145003|NCT00447278|O2|Outcome|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
1145004|NCT00447278|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
1145005|NCT00447278|O2|Outcome|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
1145006|NCT00447278|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
1145007|NCT00447278|O2|Outcome|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
1145008|NCT00447278|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
1145009|NCT00447278|O2|Outcome|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
1145010|NCT00447278|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
1145011|NCT00447278|O2|Outcome|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
1145012|NCT00447278|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
1145113|NCT00446797|B3|Baseline|Total|Total of all reporting groups
1145015|NCT00447265|B1|Baseline|Etanercept|Participant self-administered 50 mg etanercept subcutaneous injections once weekly for 24 weeks. She continued receiving her usual treatment with corticosteroids and mycophenolate mofetil.
1145016|NCT00447265|P2|Participant Flow|Placebo|Participants (or their caretaker) would administer 50 mg placebo subcutaneous injections once weekly for 24 weeks. They would continue receiving their usual treatment with corticosteroids and either mycophenolate mofetil or azathioprine.
1145017|NCT00447265|P1|Participant Flow|Etanercept|Participants (or their caretaker) would administer 50 mg etanercept subcutaneous injections once weekly for 24 weeks. They would continue receiving their usual treatment with corticosteroids and either mycophenolate mofetil or azathioprine.
1145018|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
1145019|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
1145020|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
1145021|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
1145022|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
1145023|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
1145024|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
1145025|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
1145026|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
1145027|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
1145028|NCT00447265|E1|Reported Event|Etanercept|Participant received self-administered 50 mg etanercept subcutaneous injections once weekly for 24 weeks while continuing to receive her usual lupus treatment of corticosteroids and mycophenolate mofetil.
1145029|NCT00447226|B1|Baseline|All Participants|All participants treated in the open-label phase (1500 milligrams [mg] lapatinib, orally once a day), including those subsequently randomized to lapatinib (1500 mg, orally once a day) or matching placebo
1145030|NCT00447226|P2|Participant Flow|Lapatinib 1500 Milligrams (mg)|Lapatinib 1500 mg orally, once a day
1145031|NCT00447226|P1|Participant Flow|Placebo|Identical matching placebo orally, once a day
1145034|NCT00447226|O1|Outcome|All Participants With Ovarian Cancer|All participants with ovarian cancer treated in the open-label phase (1500 mg lapatinib, orally once a day), including those subsequently randomized to lapatinib (1500 mg, orally once a day) or matching placebo
1145035|NCT00447226|O3|Outcome|Placebo|Identical matching placebo orally, once a day: up to end of Stage 2
1145036|NCT00447226|O2|Outcome|Double-blind Lapatinib 1500 mg|Double-blind lapatinib 1500 mg orally, once a day: up to end of Stage 2
1145037|NCT00447226|O1|Outcome|Open-label Lapatinib 1500 mg|Open-label lapatinib 1500 mg orally, once a day: up to end of Stage 1
1145038|NCT00447226|O3|Outcome|Placebo|Identical matching placebo orally, once a day
1145039|NCT00447226|O2|Outcome|Double-blind Lapatinib 1500 mg|Double-blind lapatinib 1500 mg orally, once a day
1145040|NCT00447226|O1|Outcome|Open-label Lapatinib 1500 mg|Open-label lapatinib 1500 mg orally, once a day
1145041|NCT00447226|O3|Outcome|Placebo|Identical matching placebo orally, once a day
1145042|NCT00447226|O2|Outcome|Double-blind Lapatinib 1500 mg|Double-blind lapatinib 1500 mg orally, once a day
1145043|NCT00447226|O1|Outcome|Open-label Lapatinib 1500 mg|Open-label lapatinib 1500 mg orally, once a day
1145044|NCT00447226|O2|Outcome|Placebo|Identical matching placebo orally, once a day
1145045|NCT00447226|O1|Outcome|Double-blind Lapatinib 1500 mg|Double-blind lapatinib 1500 mg orally, once a day
1145046|NCT00447226|O1|Outcome|Open-label Lapatinib 1500 Milligrams (mg)|Open-label lapatinib 1500 mg orally, once a day
1145047|NCT00447226|E1|Reported Event|All Participants|All participants treated in the open-label phase (1500 mg lapatinib, orally once a day), including those subsequently randomized to lapatinib (1500 mg, orally once a day) or matching placebo
1145048|NCT00447122|B1|Baseline|Treatment|lapatinib, 1,500 mg/day, and Gemcitabine, 1 gm/m2/week for 3 weeks followed by 1 week off, until disease progression
1145049|NCT00447122|P1|Participant Flow|Lapatinib and Gemcitabine|lapatinib, 1,500 mg/day, and Gemcitabine, 1 gm/m2/week for 3 weeks followed by 1 week off, until disease progression
1145050|NCT00447122|O1|Outcome|Lapatinib and Gemcitabine|lapatinib, 1,500 mg/day, and Gemcitabine, 1 gm/m2/week for 3 weeks followed by 1 week off, until disease progression
1145051|NCT00447122|E1|Reported Event|Treatment|lapatinib, 1,500 mg/day, and Gemcitabine, 1 gm/m2/week for 3 weeks followed by 1 week off, until disease progression
1145052|NCT00447057|B5|Baseline|Total|Total of all reporting groups
1145053|NCT00447057|B4|Baseline|Pemetrexed + Erlotinib (Squamous)|"Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity~Erlotinib: 150 mg given po, QD, starting on the first day of the first cycle"
1145054|NCT00447057|B3|Baseline|Pemetrexed (Squamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
1145055|NCT00447057|B2|Baseline|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity~Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
1145056|NCT00447057|B1|Baseline|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity
1145057|NCT00447057|P4|Participant Flow|Pemetrexed + Erlotinib (Squamous)|"Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given po, QD, starting on the first day of the first cycle"
1145058|NCT00447057|P3|Participant Flow|Pemetrexed (Squamous)|Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
1145059|NCT00447057|P2|Participant Flow|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given orally (po), daily (QD), starting on the first day of the first cycle"
1145182|NCT00446641|O2|Outcome|Placebo|matching placebo to cilostazol
1145060|NCT00447057|P1|Participant Flow|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21-day cycle until disease progression or unacceptable toxicity
1145061|NCT00447057|O2|Outcome|Pemetrexed + Erlotinib (Nonsquamous and Squamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
1145062|NCT00447057|O1|Outcome|Pemetrexed (Nonsquamous and Squamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
1145063|NCT00447057|O2|Outcome|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
1145064|NCT00447057|O1|Outcome|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
1145065|NCT00447057|O2|Outcome|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
1145066|NCT00447057|O1|Outcome|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
1145067|NCT00447057|O2|Outcome|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
1145068|NCT00447057|O1|Outcome|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
1145069|NCT00447057|O2|Outcome|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
1145070|NCT00447057|O1|Outcome|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
1145071|NCT00447057|O2|Outcome|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
1145072|NCT00447057|O1|Outcome|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
1145073|NCT00447057|O2|Outcome|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
1145074|NCT00447057|O1|Outcome|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
1145075|NCT00447057|E2|Reported Event|Pemetrexed + Erlotinib (Nonsquamous and Squamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
1145076|NCT00447057|E1|Reported Event|Pemetrexed (Nonsquamous and Squamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
1145077|NCT00447005|B1|Baseline|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
1145078|NCT00447005|P1|Participant Flow|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
1145079|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
1145080|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
1145081|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
1145114|NCT00446797|B2|Baseline|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
1145183|NCT00446641|O1|Outcome|Cilostazol|Cilostazol 100mg twice per day
1145082|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
1145083|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
1145084|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
1145085|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
1145086|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
1145087|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
1145088|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
1145089|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
1145090|NCT00447005|E1|Reported Event|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
1145091|NCT00446992|B1|Baseline|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
1145092|NCT00446992|P1|Participant Flow|Antipsychotic-Naive Patients|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
1145093|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
1145094|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
1145095|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
1145115|NCT00446797|B1|Baseline|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
1145096|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
1145097|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
1145098|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
1145099|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
1145100|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
1145101|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
1145338|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
1145102|NCT00446992|E1|Reported Event|Open Follow Up Group|"The patients were newly diagnosed with psychosis and this is their first exposure to an antipsychotic.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
1145103|NCT00446849|B1|Baseline|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed orally QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase. A total of 208 subjects entered the maintenance phase (152 whose UC was quiescent at screening + 56 whose UC was quiescent after the acute phase).
1145104|NCT00446849|P1|Participant Flow|Multi-Matrix System (MMX) Mesalamine|Subjects whose ulcerative colitis (UC) was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed orally once-daily [QD] at 2.4-4.8 g/day), while those whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed orally QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
1145105|NCT00446849|O1|Outcome|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed QD at 2.4-4.8 g/day), while those whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
1145106|NCT00446849|O1|Outcome|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed QD at 2.4-4.8 g/day), while those whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
1145107|NCT00446849|O1|Outcome|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed QD at 2.4-4.8 g/day), while those whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
1145108|NCT00446849|O1|Outcome|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed QD at 2.4-4.8 g/day), while those whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
1145109|NCT00446849|O1|Outcome|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed QD at 2.4-4.8 g/day), while those whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
1145110|NCT00446849|O1|Outcome|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed QD at 2.4-4.8 g/day), while those whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
1145111|NCT00446849|E2|Reported Event|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
1145112|NCT00446849|E1|Reported Event|MMX Mesalamine (Acute Phase)|Subjects whose ulcerative colitis was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed QD at 2.4-4.8 g/day).
1145116|NCT00446797|P2|Participant Flow|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
1145117|NCT00446797|P1|Participant Flow|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
1145118|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
1145119|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
1145120|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
1145121|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
1145122|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
1145123|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
1145605|NCT00445679|P3|Participant Flow|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
1145124|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
1145125|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
1145126|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
1145127|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
1145128|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
1145129|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
1145130|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
1145131|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
1145132|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
1145133|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
1145134|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
1145135|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
1145136|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
1145137|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
1145138|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
1145139|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
1145140|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
1145141|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
1145142|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
1145143|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
1145144|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
1145145|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
1145146|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
1145147|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
1146503|NCT00443729|B3|Baseline|Total|Total of all reporting groups
1145148|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
1145149|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
1145150|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
1145151|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
1145152|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
1145153|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
1145154|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
1145155|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
1145156|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
1145157|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
1145158|NCT00446797|E2|Reported Event|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
1145159|NCT00446797|E1|Reported Event|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
1145160|NCT00446654|B3|Baseline|Total|Total of all reporting groups
1145161|NCT00446654|B2|Baseline|CGC-11047 Once Every Four Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every four weeks.
1145162|NCT00446654|B1|Baseline|CGC-11047 Once Every 2 Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every two weeks.
1145163|NCT00446654|P2|Participant Flow|CGC-11047 Once Every Four Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every four weeks.
1145164|NCT00446654|P1|Participant Flow|CGC-11047 Once Every 2 Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every two weeks.
1145165|NCT00446654|O2|Outcome|CGC-11047 Once Every Four Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every four weeks.
1145166|NCT00446654|O1|Outcome|CGC-11047 Once Every 2 Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every two weeks.
1145167|NCT00446654|E2|Reported Event|CGC-11047 Once Every Four Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every four weeks.
1145168|NCT00446654|E1|Reported Event|CGC-11047 Once Every 2 Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every two weeks.
1145188|NCT00446641|E2|Reported Event|Placebo|matching placebo to cilostazol
1145189|NCT00446641|E1|Reported Event|Cilostazol|Cilostazol 100mg twice per day
1145190|NCT00446563|B3|Baseline|Total|Total of all reporting groups
1145191|NCT00446563|B2|Baseline|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145192|NCT00446563|B1|Baseline|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145193|NCT00446563|P2|Participant Flow|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145194|NCT00446563|P1|Participant Flow|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145195|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145293|NCT00446251|O1|Outcome|Rituximab Infusion and Mycophenolate Mofetil Group|Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
1145196|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145197|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145198|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145199|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145200|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145201|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145202|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145203|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145204|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145205|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145206|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145207|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145208|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145209|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145210|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145211|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145212|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145213|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145214|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145215|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145216|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145217|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145218|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145219|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145220|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145221|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145222|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145223|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145224|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145225|NCT00446563|E2|Reported Event|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145226|NCT00446563|E1|Reported Event|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
1145227|NCT00446511|B5|Baseline|Total|Total of all reporting groups
1145228|NCT00446511|B4|Baseline|Non-CKD Patients: Enalapril|Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
1145229|NCT00446511|B3|Baseline|Non-CKD Patients: Valsartan|Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
1145276|NCT00446446|E1|Reported Event|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
1145230|NCT00446511|B2|Baseline|CKD Patients: Enalapril|Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
1145231|NCT00446511|B1|Baseline|CKD Patients: Valsartan+Enalapril|Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
1145232|NCT00446511|P4|Participant Flow|Non-CKD Patients: Enalapril|Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
1145233|NCT00446511|P3|Participant Flow|Non-CKD Patients: Valsartan|Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
1145234|NCT00446511|P2|Participant Flow|CKD Patients: Enalapril|Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
1145294|NCT00446251|O1|Outcome|Rituximab Infusion and Mycophenolate Mofetil Group|Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
1145235|NCT00446511|P1|Participant Flow|CKD Patients: Valsartan+Enalapril|Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
1145236|NCT00446511|O4|Outcome|Non-CKD Patients: Enalapril|Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
1145237|NCT00446511|O3|Outcome|Non-CKD Patients: Valsartan|Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
1145238|NCT00446511|O2|Outcome|CKD Patients: Enalapril|Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
1145239|NCT00446511|O1|Outcome|CKD Patients: Valsartan+Enalapril|Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
1145240|NCT00446511|O4|Outcome|Non-CKD Patients: Enalapril|Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
1145241|NCT00446511|O3|Outcome|Non-CKD Patients: Valsartan|Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
1145242|NCT00446511|O2|Outcome|CKD Patients: Enalapril|Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
1145243|NCT00446511|O1|Outcome|CKD Patients: Valsartan+Enalapril|Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
1145244|NCT00446511|O2|Outcome|Non-CKD Patients: Enalapril|All non-CKD patients assigned to enalapril in the core study (CVAL489K2302) continued their monotherapy treatment of enalapril 10/20/40 mg stratified by weight.
1145245|NCT00446511|O1|Outcome|Non-CKD Patients: Valsartan|All non-CKD patients assigned to valsartan in the core study (CVAL489K2302) continued their monotherapy treatment of valsartan 80/160/320 mg stratified by weight.
1145246|NCT00446511|O4|Outcome|Non-CKD Patients: Enalapril|Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
1145247|NCT00446511|O3|Outcome|Non-CKD Patients: Valsartan|Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
1145248|NCT00446511|O2|Outcome|CKD Patients: Enalapril|Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
1145277|NCT00446290|B1|Baseline|DXP Arm|Docetaxel, capecitabine and oxaliplatin
1145278|NCT00446290|P1|Participant Flow|DXO Arm|"Docetaxel, capecitabine and oxaliplatin~Dose level Docetaxel(mg/m2) Capecitabine(mg/m2, twice daily) Oxaliplatin(mg/m2)~45 800 100~60 800 100~60 1,000 100~60 800 130~60 1,000 130"
1145249|NCT00446511|O1|Outcome|CKD Patients: Valsartan+Enalapril|Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
1145250|NCT00446511|O4|Outcome|Non-CKD Patients: Enalapril|Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
1145251|NCT00446511|O3|Outcome|Non-CKD Patients: Valsartan|Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
1145252|NCT00446511|O2|Outcome|CKD Patients: Enalapril|Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
1145253|NCT00446511|O1|Outcome|CKD Patients: Valsartan+Enalapril|Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
1145254|NCT00446511|E4|Reported Event|Non-CKD Patients: Enalapril|Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
1145255|NCT00446511|E3|Reported Event|CKD Patients: Enalapril|Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
1145256|NCT00446511|E2|Reported Event|Non-CKD Patients: Valsartan|Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
1145257|NCT00446511|E1|Reported Event|CKD Patients: Valsartan+Enalapril|Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
1145258|NCT00446459|B1|Baseline|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
1145259|NCT00446459|P1|Participant Flow|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
1145260|NCT00446459|O1|Outcome|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
1145261|NCT00446459|O1|Outcome|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
1145262|NCT00446459|O1|Outcome|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
1145263|NCT00446459|O1|Outcome|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
1145264|NCT00446459|O1|Outcome|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
1145265|NCT00446459|E1|Reported Event|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
1145266|NCT00446446|B1|Baseline|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
1145267|NCT00446446|P1|Participant Flow|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
1145268|NCT00446446|O1|Outcome|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
1145269|NCT00446446|O1|Outcome|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
1145270|NCT00446446|O1|Outcome|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
1145271|NCT00446446|O1|Outcome|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
1145272|NCT00446446|O1|Outcome|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
1145273|NCT00446446|O1|Outcome|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
1145274|NCT00446446|O1|Outcome|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
1145275|NCT00446446|O1|Outcome|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
1145279|NCT00446290|O1|Outcome|DXO Arm|Docetaxel, capecitabine and oxaliplatin
1145280|NCT00446290|E1|Reported Event|DXO Arm|Docetaxel, capecitabine and oxaliplatin
1145281|NCT00446264|B1|Baseline|Single Arm Group|Islet Allotransplantation Group
1145282|NCT00446264|P1|Participant Flow|Single Arm Group|Islet Allotransplantation Group
1145283|NCT00446264|O1|Outcome|Single Arm Group|Islet Allotransplantation Group
1145284|NCT00446264|O1|Outcome|Single Arm Group|Islet Allotransplantation Group
1145285|NCT00446264|O1|Outcome|Single Arm Group|Islet Allotransplantation Group
1145286|NCT00446264|O1|Outcome|Single Arm Group|Islet Allotransplantation Group
1145287|NCT00446264|O1|Outcome|Single Arm Group|Islet Allotransplantation Group
1145288|NCT00446264|O1|Outcome|Single Arm Group|Islet Allotransplantation Group
1145289|NCT00446264|E1|Reported Event|Single Arm Group|Islet Allotransplantation Group
1145290|NCT00446251|B1|Baseline|Rituximab Infusion and Mycophenolate Mofetil Group|Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
1145291|NCT00446251|P1|Participant Flow|Rituximab Infusion and Mycophenolate Mofetil Group|Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
1145292|NCT00446251|O1|Outcome|Rituximab Infusion and Mycophenolate Mofetil Group|Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
1149028|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
1145295|NCT00446251|E1|Reported Event|Rituximab Infusion and Mycophenolate Mofetil Group|Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
1145296|NCT00446199|B5|Baseline|Total|Total of all reporting groups
1145297|NCT00446199|B4|Baseline|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
1145298|NCT00446199|B3|Baseline|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
1145299|NCT00446199|B2|Baseline|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145300|NCT00446199|B1|Baseline|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145301|NCT00446199|P4|Participant Flow|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
1145302|NCT00446199|P3|Participant Flow|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
1145303|NCT00446199|P2|Participant Flow|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145304|NCT00446199|P1|Participant Flow|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145305|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
1145306|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
1145307|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145308|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145309|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
1145310|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
1145311|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145312|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145313|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
1145314|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
1145315|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145316|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145317|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
1145318|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
1145319|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145320|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145321|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
1145322|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
1145366|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
1145323|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145324|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145325|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
1145326|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
1145327|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145328|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145329|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
1145330|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
1145331|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145332|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145333|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
1145334|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
1145335|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145336|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1149029|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
1145339|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145340|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145341|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
1145342|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
1145343|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145344|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145345|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
1145346|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
1145347|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145348|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145349|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
1145350|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
1145351|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145352|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145353|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
1145354|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
1145355|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145356|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145357|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
1145358|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
1145359|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145360|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145361|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
1145362|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
1145363|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145364|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145365|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
1145932|NCT00445003|O1|Outcome|Sham Injection|Sham injection at baseline and 4 weeks
1145367|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145368|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145369|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
1145370|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
1145371|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145372|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145373|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
1145374|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
1145375|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145376|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145377|NCT00446199|E4|Reported Event|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
1145378|NCT00446199|E3|Reported Event|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle)
1145379|NCT00446199|E2|Reported Event|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145380|NCT00446199|E1|Reported Event|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
1145381|NCT00446147|B3|Baseline|Total|Total of all reporting groups
1145382|NCT00446147|B2|Baseline|Pyridoxine|"100 mg twice per day~Pyridoxine: 100mg BID/daily, Per oral"
1149030|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
1145383|NCT00446147|B1|Baseline|Placebo|"one tablet twice per day, which is identical to pyridoxine~Placebo: placebo 100mg BID/daily, Per oral"
1145384|NCT00446147|P2|Participant Flow|Pyridoxine|"100 mg twice per day~Pyridoxine: 100mg BID/daily, Per oral"
1145385|NCT00446147|P1|Participant Flow|Placebo|"one tablet twice per day, which is identical to pyridoxine~Placebo: placebo 100mg BID/daily, Per oral"
1145386|NCT00446147|O2|Outcome|Pyridoxine|"100 mg twice per day~Pyridoxine: 100mg BID/daily, Per oral"
1145387|NCT00446147|O1|Outcome|Placebo|"one tablet twice per day, which is identical to pyridoxine~Placebo: placebo 100mg BID/daily, Per oral"
1145388|NCT00446147|O2|Outcome|Pyridoxine|"100 mg twice per day~Pyridoxine: 100mg BID/daily, Per oral"
1145389|NCT00446147|O1|Outcome|Placebo|"one tablet twice per day, which is identical to pyridoxine~Placebo: placebo 100mg BID/daily, Per oral"
1145390|NCT00446147|E2|Reported Event|Pyridoxine|"100 mg twice per day~Pyridoxine: 100mg BID/daily, Per oral"
1145391|NCT00446147|E1|Reported Event|Placebo|"one tablet twice per day, which is identical to pyridoxine~Placebo: placebo 100mg BID/daily, Per oral"
1145392|NCT00446134|B5|Baseline|Total|Total of all reporting groups
1145393|NCT00446134|B4|Baseline|Ribavirin 800 mg/Day|Oral ribavirin 800 mg/day (body weight <65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
1145394|NCT00446134|B3|Baseline|Taribavirin 30 mg/kg/Day|Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
1145395|NCT00446134|B2|Baseline|Taribavirin 25 mg/kg/Day|Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
1145396|NCT00446134|B1|Baseline|Taribavirin 20 mg/kg/Day|Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
1145397|NCT00446134|P4|Participant Flow|Ribavirin 800 mg/Day|Oral ribavirin 800 mg/day (body weight <65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
1145398|NCT00446134|P3|Participant Flow|Taribavirin 30 mg/kg/Day|Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
1145399|NCT00446134|P2|Participant Flow|Taribavirin 25 mg/kg/Day|Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
1145400|NCT00446134|P1|Participant Flow|Taribavirin 20 mg/kg/Day|Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
1145401|NCT00446134|O4|Outcome|Ribavirin 800 mg/Day|Oral ribavirin 800 mg/day (body weight <65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
1145402|NCT00446134|O3|Outcome|Taribavirin 30 mg/kg/Day|Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
1145403|NCT00446134|O2|Outcome|Taribavirin 25 mg/kg/Day|Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
1145404|NCT00446134|O1|Outcome|Taribavirin 20 mg/kg/Day|Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
1145405|NCT00446134|O4|Outcome|Ribavirin 800 mg/Day|Oral ribavirin 800 mg/day (body weight <65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
1145444|NCT00446095|O2|Outcome|Phase II: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
1145406|NCT00446134|O3|Outcome|Taribavirin 30 mg/kg/Day|Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
1145407|NCT00446134|O2|Outcome|Taribavirin 25 mg/kg/Day|Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
1145408|NCT00446134|O1|Outcome|Taribavirin 20 mg/kg/Day|Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
1145409|NCT00446134|O4|Outcome|Ribavirin 800 mg/Day|Oral ribavirin 800 mg/day (body weight <65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
1145410|NCT00446134|O3|Outcome|Taribavirin 30 mg/kg/Day|Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
1145411|NCT00446134|O2|Outcome|Taribavirin 25 mg/kg/Day|Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
1145412|NCT00446134|O1|Outcome|Taribavirin 20 mg/kg/Day|Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
1145413|NCT00446134|O4|Outcome|Ribavirin 800 mg/Day|Oral ribavirin 800 mg/day (body weight <65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
1145414|NCT00446134|O3|Outcome|Taribavirin 30 mg/kg/Day|Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
1145415|NCT00446134|O2|Outcome|Taribavirin 25 mg/kg/Day|Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
1145416|NCT00446134|O1|Outcome|Taribavirin 20 mg/kg/Day|Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
1145503|NCT00445770|P2|Participant Flow|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
1145417|NCT00446134|E4|Reported Event|Ribavirin 800 mg/Day|Oral ribavirin 800 mg/day (body weight <65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
1145418|NCT00446134|E3|Reported Event|Taribavirin 30 mg/kg/Day|Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
1145419|NCT00446134|E2|Reported Event|Taribavirin 25 mg/kg/Day|Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
1145420|NCT00446134|E1|Reported Event|Taribavirin 20 mg/kg/Day|Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
1145421|NCT00446095|B6|Baseline|Total|Total of all reporting groups
1145422|NCT00446095|B5|Baseline|Phase I: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase I
1145423|NCT00446095|B4|Baseline|Phase I: 200mg R788 BID|Patients who received 200mg R788 orally twice daily (PO BID) in Phase I
1145424|NCT00446095|B3|Baseline|Phase II: Other Lymphomas|Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
1145425|NCT00446095|B2|Baseline|Phase II: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
1145426|NCT00446095|B1|Baseline|Phase II: DLBCL|Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
1145427|NCT00446095|P5|Participant Flow|Phase I: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase I
1145428|NCT00446095|P4|Participant Flow|Phase I: 200mg R788 BID|Patients who received 200mg R788 orally twice daily (PO BID) in Phase I
1145429|NCT00446095|P3|Participant Flow|Phase II: Other Lymphomas|Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
1145430|NCT00446095|P2|Participant Flow|Phase II: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
1145431|NCT00446095|P1|Participant Flow|Phase II: DLBCL|Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
1145432|NCT00446095|O3|Outcome|Phase II: Other Lymphomas|Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
1145433|NCT00446095|O2|Outcome|Phase II: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
1145434|NCT00446095|O1|Outcome|Phase II: DLBCL|Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
1145435|NCT00446095|O3|Outcome|Phase II: Other Lymphomas|Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
1145436|NCT00446095|O2|Outcome|Phase II: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
1145437|NCT00446095|O1|Outcome|Phase II: DLBCL|Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
1145438|NCT00446095|O4|Outcome|Phase 1: 200mg and 250mg R788 BID|Patients who received 200mg or 250mg R788 orally twice daily (PO BID) in Phase I
1145439|NCT00446095|O3|Outcome|Phase II: Other Lymphomas|Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
1145440|NCT00446095|O2|Outcome|Phase II: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
1145441|NCT00446095|O1|Outcome|Phase II: DLBCL|Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
1145442|NCT00446095|O4|Outcome|Phase 1: 200mg and 250mg R788 BID|Patients who received 200mg or 250mg R788 orally twice daily (PO BID) in Phase I
1145443|NCT00446095|O3|Outcome|Phase II: Other Lymphomas|Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
1145445|NCT00446095|O1|Outcome|Phase II: DLBCL|Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
1145446|NCT00446095|E5|Reported Event|Phase I: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase I
1145447|NCT00446095|E4|Reported Event|Phase I: 200mg R788 BID|Patients who received 200mg R788 orally twice daily (PO BID) in Phase I
1145448|NCT00446095|E3|Reported Event|Phase II: Other Lymphomas|Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
1145449|NCT00446095|E2|Reported Event|Phase II: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
1145450|NCT00446095|E1|Reported Event|Phase II: DLBCL|Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
1145451|NCT00446030|B3|Baseline|Total|Total of all reporting groups
1145452|NCT00446030|B2|Baseline|Stratum 2: TCH + Bevacizumab|HER2 positive participants were administered chemotherapy with docetaxel, carboplatin and trastuzumab (TCH) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab and trastuzumab every 3 weeks for a total of 52 weeks.
1145453|NCT00446030|B1|Baseline|Stratum 1: TAC + Bevacizumab|HER2 negative participants were administered chemotherapy with docetaxel, doxorubicin and cyclosphosphamide (TAC) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.
1145454|NCT00446030|P2|Participant Flow|Stratum 2: TCH + Bevacizumab|HER2 positive participants were administered chemotherapy with docetaxel, carboplatin and trastuzumab (TCH) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab and trastuzumab every 3 weeks for a total of 52 weeks.
1145455|NCT00446030|P1|Participant Flow|Stratum 1: TAC + Bevacizumab|HER2 negative participants were administered chemotherapy with docetaxel, doxorubicin and cyclosphosphamide (TAC) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.
1145501|NCT00445770|B1|Baseline|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
1145456|NCT00446030|O2|Outcome|Stratum 2: TCH + Bevacizumab|HER2 positive participants were administered chemotherapy with docetaxel, carboplatin and trastuzumab (TCH) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab and trastuzumab every 3 weeks for a total of 52 weeks.
1145457|NCT00446030|O1|Outcome|Stratum 1: TAC + Bevacizumab|HER2 negative participants were administered chemotherapy with docetaxel, doxorubicin and cyclosphosphamide (TAC) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.
1145458|NCT00446030|O2|Outcome|Stratum 2: TCH + Bevacizumab|HER2 positive participants were administered chemotherapy with docetaxel, carboplatin and trastuzumab (TCH) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab and trastuzumab every 3 weeks for a total of 52 weeks.
1145459|NCT00446030|O1|Outcome|Stratum 1: TAC + Bevacizumab|HER2 negative participants were administered chemotherapy with docetaxel, doxorubicin and cyclosphosphamide (TAC) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.
1145460|NCT00446030|E2|Reported Event|Stratum 2: TCH + Bevacizumab|HER2 positive participants were administered chemotherapy with docetaxel, carboplatin and trastuzumab (TCH) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab and trastuzumab every 3 weeks for a total of 52 weeks.
1145461|NCT00446030|E1|Reported Event|Stratum 1: TAC + Bevacizumab|HER2 negative participants were administered chemotherapy with docetaxel, doxorubicin and cyclosphosphamide (TAC) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.
1145462|NCT00445939|B4|Baseline|Total|Total of all reporting groups
1145463|NCT00445939|B3|Baseline|Placebo|Placebo at Week 0, placebo Week 2
1145464|NCT00445939|B2|Baseline|Adalimumab 80 mg/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2
1145465|NCT00445939|B1|Baseline|Adalimumab 160 mg/80 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2
1145466|NCT00445939|P4|Participant Flow|Adalimumab 40mg /40 mg|Non-responders continued after 4 weeks, Adalimumab 160 at Week 0, 80 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6; Adalimumab 80 mg at Week 0, 40 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6.
1145467|NCT00445939|P3|Participant Flow|Placebo|Placebo at Week 0, placebo at Week 2
1145468|NCT00445939|P2|Participant Flow|Adalimumab 80 mg/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2
1145469|NCT00445939|P1|Participant Flow|Adalimumab 160 mg/80 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2
1145470|NCT00445939|O3|Outcome|Placebo + Adalimumab 160/80 mg|Placebo at Week 0, placebo at Week 2, 160 mg at Week 4, 80 mg at Week 6
1145471|NCT00445939|O2|Outcome|Adalimumab 80 mg/40 mg + 40/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6
1145472|NCT00445939|O1|Outcome|Adaliumab 160 mg/80 mg + 40/40 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6
1145473|NCT00445939|O3|Outcome|Placebo + Adalimumab 160/80 mg|Placebo at Week 0, placebo at Week 2, adalimumab 160 mg at Week 4, and adalimumab 80 mg at Week 6
1145474|NCT00445939|O2|Outcome|Adalimumab 80 mg/40 mg + 40/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6
1145475|NCT00445939|O1|Outcome|Adaliumab 160 mg/80 mg + 40/40 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6
1145476|NCT00445939|O3|Outcome|Placebo|Placebo at Week 0, placebo at Week 2,
1145477|NCT00445939|O2|Outcome|Adalimumab 80 mg/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2
1145478|NCT00445939|O1|Outcome|Adaliumab 160 mg/80 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2
1145479|NCT00445939|O3|Outcome|Placebo + 160/80 mg|Placebo at Week 0, placebo at Week 2
1145480|NCT00445939|O2|Outcome|Adalimumab 80 mg/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2
1145481|NCT00445939|O1|Outcome|Adaliumab 160 mg/80 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2
1145482|NCT00445939|O3|Outcome|Placebo|Placebo at Week 0, placebo at Week 2
1145483|NCT00445939|O2|Outcome|Adalimumab 80 mg/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2
1145484|NCT00445939|O1|Outcome|Adalimumab 160 mg/80 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2
1145485|NCT00445939|E6|Reported Event|Placebo + Adalimumab 160/80 mg|Placebo at Week 0, Placebo at Week 2, 160 mg at Week 4, 80 mg at Week 6
1145486|NCT00445939|E5|Reported Event|80/40 mg + 40/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6
1145487|NCT00445939|E4|Reported Event|Adalimumab 160 mg/80 mg + 40/40 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6
1145488|NCT00445939|E3|Reported Event|Placebo|Placebo at Week 0, placebo at Week 2
1145489|NCT00445939|E2|Reported Event|Adalimumab 80 mg/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2
1145490|NCT00445939|E1|Reported Event|Adaliumab 160 mg/80 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2
1145491|NCT00445848|B1|Baseline|Erlotinib and Bevacizumab|Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
1145492|NCT00445848|P1|Participant Flow|Erlotinib and Bevacizumab|Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
1145493|NCT00445848|O1|Outcome|Erlotinib and Bevacizumab|Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
1145494|NCT00445848|O1|Outcome|Erlotinib and Bevacizumab|Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
1145495|NCT00445848|O1|Outcome|Erlotinib and Bevacizumab|Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
1145496|NCT00445848|O1|Outcome|Erlotinib and Bevacizumab|Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
1145497|NCT00445848|E1|Reported Event|Erlotinib and Bevacizumab|Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
1145498|NCT00445770|B4|Baseline|Total|Total of all reporting groups
1145499|NCT00445770|B3|Baseline|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
1145500|NCT00445770|B2|Baseline|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
1145502|NCT00445770|P3|Participant Flow|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
1145504|NCT00445770|P1|Participant Flow|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
1145505|NCT00445770|O2|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
1145506|NCT00445770|O1|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
1145507|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
1145508|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
1145509|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
1145510|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
1145511|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
1145512|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
1145513|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
1145514|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
1145515|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
1145516|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
1145517|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
1145518|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
1145519|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
1145520|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
1145521|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
1145522|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
1145523|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
1145524|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
1145525|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
1145526|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
1145527|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
1145528|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
1145529|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
1145530|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
1145531|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
1145532|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
1145533|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
1145534|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
1145535|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
1145536|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
1145537|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
1145538|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
1145539|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
1145540|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
1145541|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
1145542|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
1145543|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
1145544|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
1145545|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
1145598|NCT00445705|E1|Reported Event|Placebo|Part A: Placebo every 12 hours for 4 weeks
1145546|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
1145547|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
1145548|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
1145549|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
1145550|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
1145551|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
1145552|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
1145553|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
1145554|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
1145555|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
1145556|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
1145557|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
1145558|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
1145559|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
1145560|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
1145561|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
1145562|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
1145563|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
1145564|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
1145565|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
1145566|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
1145567|NCT00445770|E3|Reported Event|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
1145568|NCT00445770|E2|Reported Event|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
1145569|NCT00445770|E1|Reported Event|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
1145570|NCT00445705|B5|Baseline|Total|Total of all reporting groups
1145571|NCT00445705|B4|Baseline|AGN 203818 60 mg|Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
1145572|NCT00445705|B3|Baseline|AGN 203818 20 mg|Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
1145573|NCT00445705|B2|Baseline|AGN 203818 3 mg|Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
1145574|NCT00445705|B1|Baseline|Placebo|Part A: Placebo every 12 hours for 4 weeks
1156282|NCT00421993|O4|Outcome|Gel Vehicle|Topical Gel Vehicle
1145575|NCT00445705|P4|Participant Flow|AGN 203818 60 mg|Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
1145576|NCT00445705|P3|Participant Flow|AGN 203818 20 mg|Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
1145577|NCT00445705|P2|Participant Flow|AGN 203818 3 mg|Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
1145578|NCT00445705|P1|Participant Flow|Placebo|Part A: Placebo every 12 hours for 4 weeks
1145579|NCT00445705|O4|Outcome|AGN 203818 60 mg|Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
1145580|NCT00445705|O3|Outcome|AGN 203818 20 mg|Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
1145581|NCT00445705|O2|Outcome|AGN 203818 3 mg|Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
1145582|NCT00445705|O1|Outcome|Placebo|Part A: Placebo every 12 hours for 4 weeks
1145583|NCT00445705|O4|Outcome|AGN 203818 60 mg|Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
1145584|NCT00445705|O3|Outcome|AGN 203818 20 mg|Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
1145585|NCT00445705|O2|Outcome|AGN 203818 3 mg|Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
1145586|NCT00445705|O1|Outcome|Placebo|Part A: Placebo every 12 hours for 4 weeks
1145587|NCT00445705|O4|Outcome|AGN 203818 60 mg|Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
1145588|NCT00445705|O3|Outcome|AGN 203818 20 mg|Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
1145589|NCT00445705|O2|Outcome|AGN 203818 3 mg|Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
1145590|NCT00445705|O1|Outcome|Placebo|Part A: Placebo every 12 hours for 4 weeks
1145591|NCT00445705|O4|Outcome|AGN 203818 60 mg|Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
1145592|NCT00445705|O3|Outcome|AGN 203818 20 mg|Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
1145593|NCT00445705|O2|Outcome|AGN 203818 3 mg|Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
1145594|NCT00445705|O1|Outcome|Placebo|Part A: Placebo every 12 hours for 4 weeks
1145595|NCT00445705|E4|Reported Event|AGN 203818 60 mg|Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
1145596|NCT00445705|E3|Reported Event|AGN 203818 20 mg|Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
1145597|NCT00445705|E2|Reported Event|AGN 203818 3 mg|Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
1145606|NCT00445679|P2|Participant Flow|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
1145607|NCT00445679|P1|Participant Flow|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
1145608|NCT00445679|O4|Outcome|Paroxetine 20|Paroxetine 20 mg/day
1145609|NCT00445679|O3|Outcome|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
1145610|NCT00445679|O2|Outcome|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
1145611|NCT00445679|O1|Outcome|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
1145612|NCT00445679|O4|Outcome|Paroxetine 20|Paroxetine 20 mg/day
1145613|NCT00445679|O3|Outcome|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
1145614|NCT00445679|O2|Outcome|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
1145615|NCT00445679|O1|Outcome|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
1145616|NCT00445679|O4|Outcome|Paroxetine 20|Paroxetine 20 mg/day
1145617|NCT00445679|O3|Outcome|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
1145618|NCT00445679|O2|Outcome|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
1145619|NCT00445679|O1|Outcome|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
1145620|NCT00445679|O4|Outcome|Paroxetine 20|Paroxetine 20 mg/day
1145621|NCT00445679|O3|Outcome|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
1145622|NCT00445679|O2|Outcome|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
1145623|NCT00445679|O1|Outcome|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
1145624|NCT00445679|O4|Outcome|Paroxetine 20|Paroxetine 20 mg/day
1145625|NCT00445679|O3|Outcome|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
1145626|NCT00445679|O2|Outcome|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
1145627|NCT00445679|O1|Outcome|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
1145628|NCT00445679|O4|Outcome|Paroxetine 20|Paroxetine 20 mg/day
1145629|NCT00445679|O3|Outcome|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
1145630|NCT00445679|O2|Outcome|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
1145631|NCT00445679|O1|Outcome|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
1145632|NCT00445679|O4|Outcome|Paroxetine 20|Paroxetine 20 mg/day
1145633|NCT00445679|O3|Outcome|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
1145634|NCT00445679|O2|Outcome|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
1145635|NCT00445679|O1|Outcome|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
1145636|NCT00445679|E4|Reported Event|Paroxetine 20|Paroxetine 20 mg/day
1145637|NCT00445679|E3|Reported Event|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
1145638|NCT00445679|E2|Reported Event|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
1145639|NCT00445679|E1|Reported Event|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
1145933|NCT00445003|O3|Outcome|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
1145640|NCT00445588|B1|Baseline|Treatment|"Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study~erlotinib hydrochloride: 150mg Given orally once daily~sorafenib tosylate: 400mg Given orally twice daily~pharmacological study: Correlative studies"
1145641|NCT00445588|P1|Participant Flow|Treatment|"Patients receive oral erlotinib hydrochloride 150 mg once daily and oral sorafenib tosylate 400 mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study~erlotinib hydrochloride 150mg: Given orally once daily~sorafenib tosylate 400mg: Given orally twice daily~pharmacological study: Correlative studies"
1145642|NCT00445588|O1|Outcome|Treatment|"Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study~erlotinib hydrochloride: 150mg Given orally once daily~sorafenib tosylate: 400mg Given orally twice daily~pharmacological study: Correlative studies"
1145643|NCT00445588|O1|Outcome|Treatment|"Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study~erlotinib hydrochloride 150mg: Given orally once daily~sorafenib tosylate 400mg: Given orally twice daily~pharmacological study: Correlative studies"
1145644|NCT00445588|E1|Reported Event|Treatment|"Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study~erlotinib hydrochloride: 150mg Given orally once daily~sorafenib tosylate: 400mg Given orally twice daily~pharmacological study: Correlative studies"
1145645|NCT00445549|B1|Baseline|Vandetanib Treatment|300 mg daily oral dose, 28 day cycle
1145646|NCT00445549|P1|Participant Flow|Vandetanib Treatment|300 mg daily oral dose, 28 day cycle
1145647|NCT00445549|O1|Outcome|Vandetanib Treatment|300 mg daily oral dose, 28 day cycle
1145648|NCT00445549|O1|Outcome|Vandetanib Treatment|300 mg daily oral dose, 28 day cycle
1145649|NCT00445549|E1|Reported Event|Vandetanib Treatment|300 mg daily oral dose, 28 day cycle
1145650|NCT00445484|B3|Baseline|Total|Total of all reporting groups
1145651|NCT00445484|B2|Baseline|Group 2|"Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
1145677|NCT00445432|O1|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
1146798|NCT00443118|E3|Reported Event|SIB Without PEEP|Subjects allocated to be ventilated with Self Inflating Bag without PEEP valve
1145652|NCT00445484|B1|Baseline|Group 1|"Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
1145653|NCT00445484|P2|Participant Flow|Group 1|"Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
1145654|NCT00445484|P1|Participant Flow|Group 2|"Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
1145655|NCT00445484|O2|Outcome|Vaccine Started 45 Days After Lenalidomide|"Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
1145656|NCT00445484|O1|Outcome|Vaccine Started 14 Days Prior to Lenalidomide|"Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
1145657|NCT00445484|O2|Outcome|Vaccine Started 45 Days After Lenalidomide|"Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
1145658|NCT00445484|O1|Outcome|Vaccine Started 14 Days Prior to Lenalidomide|"Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
1145659|NCT00445484|O2|Outcome|Vaccine Started 45 Days After Lenalidomide|"Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
1145660|NCT00445484|O1|Outcome|Vaccine Started 14 Days Prior to Lenalidomide|"Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
1145661|NCT00445484|O2|Outcome|Vaccine Started 45 Days After Lenalidomide|"Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
1145662|NCT00445484|O1|Outcome|Vaccine Started 14 Days Prior to Lenalidomide|"Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
1145663|NCT00445484|E2|Reported Event|Group 2|"Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
1145664|NCT00445484|E1|Reported Event|Group 1|"Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
1145665|NCT00445432|B4|Baseline|Total|Total of all reporting groups
1145666|NCT00445432|B3|Baseline|OL Adalimumab 40 mg Eow|Open-label adalimumab 40 mg every other week
1145667|NCT00445432|B2|Baseline|Placebo Eow|Double-blind adalimumab placebo every other week
1145668|NCT00445432|B1|Baseline|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
1145669|NCT00445432|P4|Participant Flow|Any Adalimumab|All participants in NCT00445432 (Study M06-837) who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
1145670|NCT00445432|P3|Participant Flow|OL Adalimumab 40 mg Eow|Open-label adalimumab 40 mg every other week
1145671|NCT00445432|P2|Participant Flow|Placebo Eow|Double-blind adalimumab placebo every other week
1145672|NCT00445432|P1|Participant Flow|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
1145673|NCT00445432|O1|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
1145674|NCT00445432|O1|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
1145675|NCT00445432|O1|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
1145676|NCT00445432|O1|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
1147595|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
1145678|NCT00445432|O1|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
1145679|NCT00445432|O1|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
1145680|NCT00445432|O1|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
1145681|NCT00445432|O2|Outcome|Placebo Eow|Double-blind adalimumab placebo every other week
1145682|NCT00445432|O1|Outcome|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
1145683|NCT00445432|O2|Outcome|Placebo Eow|Double-blind adalimumab placebo every other week
1145684|NCT00445432|O1|Outcome|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
1145685|NCT00445432|O2|Outcome|Placebo Eow|Double-blind adalimumab placebo every other week
1145686|NCT00445432|O1|Outcome|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
1145687|NCT00445432|O2|Outcome|Placebo Eow|Double-blind adalimumab placebo every other week
1145688|NCT00445432|O1|Outcome|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
1145689|NCT00445432|O1|Outcome|OL Adalimumab 40 mg Eow|Open-label adalimumab 40 mg every other week
1145690|NCT00445432|O2|Outcome|Placebo Eow|Double-blind adalimumab placebo every other week
1145691|NCT00445432|O1|Outcome|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
1145692|NCT00445432|O3|Outcome|OL Adalimumab 40 mg Eow|Open-label adalimumab 40 mg every other week
1145693|NCT00445432|O2|Outcome|Placebo Eow|Double-blind adalimumab placebo every other week
1145694|NCT00445432|O1|Outcome|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
1145695|NCT00445432|O3|Outcome|OL Adalimumab 40 mg Eow|Open-label adalimumab 40 mg every other week
1145696|NCT00445432|O2|Outcome|Placebo Eow|Double-blind adalimumab placebo every other week
1145697|NCT00445432|O1|Outcome|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
1145698|NCT00445432|O2|Outcome|Placebo Eow|Double-blind adalimumab placebo every other week
1145699|NCT00445432|O1|Outcome|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
1145700|NCT00445432|E4|Reported Event|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
1145701|NCT00445432|E3|Reported Event|OL Adalimumab 40 mg Eow|Open-label adalimumab 40 mg every other week
1145702|NCT00445432|E2|Reported Event|Placebo Eow|Double-blind adalimumab placebo every other week
1145703|NCT00445432|E1|Reported Event|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
1145704|NCT00445341|B1|Baseline|Flavopiridol in Lymphoma Patients|Flavopiridol 30 mg/m^2 is given weekly for 4 weeks followed by a 2 week break for up to 6 cycles. It is given through a vein as a 30 minute infusion followed by a 4 hour infusion.
1145705|NCT00445341|P1|Participant Flow|Flavopiridol in Lymphoma Patients|Flavopiridol 30 mg/m^2 is given weekly for 4 weeks followed by a 2 week break for up to 6 cycles. It is given through a vein as a 30 minute infusion followed by a 4 hour infusion.
1145706|NCT00445341|O1|Outcome|Flavopiridol in Lymphoma Patients|Flavopiridol 30 mg/m^2 is given weekly for 4 weeks followed by a 2 week break for up to 6 cycles. It is given through a vein as a 30 minute infusion followed by a 4 hour infusion.
1145934|NCT00445003|O2|Outcome|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
1145707|NCT00445341|O1|Outcome|Flavopiridol in Lymphoma Patients|Flavopiridol 30 mg/m^2 is given weekly for 4 weeks followed by a 2 week break for up to 6 cycles. It is given through a vein as a 30 minute infusion followed by a 4 hour infusion.
1145708|NCT00445341|E1|Reported Event|Flavopiridol in Lymphoma Patients|Flavopiridol 30 mg/m^2 is given weekly for 4 weeks followed by a 2 week break for up to 6 cycles. It is given through a vein as a 30 minute infusion followed by a 4 hour infusion.
1145709|NCT00445328|B3|Baseline|Total|Total of all reporting groups
1145710|NCT00445328|B2|Baseline|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
1145711|NCT00445328|B1|Baseline|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
1145712|NCT00445328|P2|Participant Flow|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
1145713|NCT00445328|P1|Participant Flow|Dalteparin|5000 IU (International Units) dalteparin in 0.2 mL (milliliters) subcutaneously once a day (Arm A)
1145714|NCT00445328|O2|Outcome|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
1145715|NCT00445328|O1|Outcome|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
1145716|NCT00445328|O2|Outcome|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
1145717|NCT00445328|O1|Outcome|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
1145718|NCT00445328|O2|Outcome|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
1145719|NCT00445328|O1|Outcome|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
1145720|NCT00445328|O2|Outcome|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
1145721|NCT00445328|O1|Outcome|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
1145722|NCT00445328|O2|Outcome|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
1145723|NCT00445328|O1|Outcome|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
1145724|NCT00445328|O2|Outcome|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
1145725|NCT00445328|O1|Outcome|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
1145726|NCT00445328|O2|Outcome|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
1145727|NCT00445328|O1|Outcome|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
1147596|NCT00441480|O2|Outcome|Control|Corn oil
1145728|NCT00445328|E2|Reported Event|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
1145729|NCT00445328|E1|Reported Event|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
1145730|NCT00445315|B6|Baseline|Total|Total of all reporting groups
1145731|NCT00445315|B5|Baseline|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
1145732|NCT00445315|B4|Baseline|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145733|NCT00445315|B3|Baseline|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
1145734|NCT00445315|B2|Baseline|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145735|NCT00445315|B1|Baseline|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145736|NCT00445315|P5|Participant Flow|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
1145737|NCT00445315|P4|Participant Flow|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145738|NCT00445315|P3|Participant Flow|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
1145739|NCT00445315|P2|Participant Flow|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145740|NCT00445315|P1|Participant Flow|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145741|NCT00445315|O5|Outcome|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
1145742|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145743|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
1145744|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145745|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145746|NCT00445315|O5|Outcome|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
1145747|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145748|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
1145749|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145750|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145751|NCT00445315|O5|Outcome|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
1145752|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145753|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
1145754|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145755|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145756|NCT00445315|O5|Outcome|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
1145757|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145758|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
1145759|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145760|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145761|NCT00445315|O5|Outcome|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
1145762|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145763|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
1145764|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145765|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145766|NCT00445315|O3|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145767|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145768|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145769|NCT00445315|O3|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145770|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145771|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145772|NCT00445315|O3|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145773|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145774|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145775|NCT00445315|O3|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145776|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145777|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145778|NCT00445315|O3|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145779|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145780|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145781|NCT00445315|O3|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145782|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145783|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145784|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145785|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
1145786|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145787|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145788|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145789|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
1145790|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145791|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145792|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145793|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
1145794|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145795|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145796|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145797|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
1145798|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145799|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145800|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145801|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
1145802|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145803|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145804|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145805|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
1145806|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145807|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145808|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145809|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
1145810|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145811|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145812|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145813|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
1145814|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145815|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145816|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145817|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
1145818|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145819|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145820|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145821|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
1145822|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145823|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145824|NCT00445315|E5|Reported Event|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
1145825|NCT00445315|E4|Reported Event|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145826|NCT00445315|E3|Reported Event|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
1145827|NCT00445315|E2|Reported Event|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145828|NCT00445315|E1|Reported Event|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
1145829|NCT00445302|B5|Baseline|Total|Total of all reporting groups
1145898|NCT00445211|O1|Outcome|Intra-Aortic Balloon Pump With Heparin|"Intra-Aortic Balloon Pump (IABP) with Heparin~Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP)."
1145830|NCT00445302|B4|Baseline|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
1145831|NCT00445302|B3|Baseline|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
1145832|NCT00445302|B2|Baseline|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
1145833|NCT00445302|B1|Baseline|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
1145834|NCT00445302|P4|Participant Flow|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
1145835|NCT00445302|P3|Participant Flow|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
1145836|NCT00445302|P2|Participant Flow|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
1145837|NCT00445302|P1|Participant Flow|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
1145838|NCT00445302|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
1145839|NCT00445302|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
1145840|NCT00445302|O2|Outcome|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
1145841|NCT00445302|O1|Outcome|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
1145986|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
1145842|NCT00445302|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
1145843|NCT00445302|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
1145844|NCT00445302|O2|Outcome|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
1145845|NCT00445302|O1|Outcome|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
1145846|NCT00445302|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
1145847|NCT00445302|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
1145848|NCT00445302|O2|Outcome|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
1145849|NCT00445302|O1|Outcome|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
1145850|NCT00445302|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
1145851|NCT00445302|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
1145852|NCT00445302|O2|Outcome|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
1145853|NCT00445302|O1|Outcome|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
1145854|NCT00445302|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
1145855|NCT00445302|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
1145856|NCT00445302|O2|Outcome|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
1145857|NCT00445302|O1|Outcome|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
1145858|NCT00445302|E4|Reported Event|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
1145930|NCT00445003|O3|Outcome|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
1145859|NCT00445302|E3|Reported Event|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
1145860|NCT00445302|E2|Reported Event|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
1145861|NCT00445302|E1|Reported Event|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
1145862|NCT00445263|B3|Baseline|Total|Total of all reporting groups
1145863|NCT00445263|B2|Baseline|Delayed Invasive Strategy|Coronarography after six hours
1145864|NCT00445263|B1|Baseline|Early Invasive Strategy|Tirofiban and coronarography within six hours
1145865|NCT00445263|P2|Participant Flow|Delayed Invasive Strategy|Coronarography after six hours
1145866|NCT00445263|P1|Participant Flow|Early Invasive Strategy|Tirofiban and coronarography within six hours
1145867|NCT00445263|O2|Outcome|Delayed Invasive Strategy|Coronarography after six hours
1145868|NCT00445263|O1|Outcome|Early Invasive Strategy|Tirofiban and coronarography within six hours
1145869|NCT00445263|E2|Reported Event|Delayed Invasive Strategy|Coronarography after six hours
1145870|NCT00445263|E1|Reported Event|Early Invasive Strategy|Tirofiban and coronarography within six hours
1145871|NCT00445224|B3|Baseline|Total|Total of all reporting groups
1145872|NCT00445224|B2|Baseline|Quadricep Group Then Combined Exercises|Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
1145873|NCT00445224|B1|Baseline|Hip Strengthening Then Combined Exercises|Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
1145874|NCT00445224|P2|Participant Flow|Quadricep Group Then Combined Exercises|Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
1145875|NCT00445224|P1|Participant Flow|Hip Strengthening Then Combined Exercises|Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
1145876|NCT00445224|O2|Outcome|Quadricep Group Then Combined Exercises|Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
1149031|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
1145877|NCT00445224|O1|Outcome|Hip Strengthening Then Combined Exercises|Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
1145878|NCT00445224|O2|Outcome|Quadricep Group Then Combined Exercises|Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
1145879|NCT00445224|O1|Outcome|Hip Strengthening Then Combined Exercises|Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
1145880|NCT00445224|O2|Outcome|Quadricep Group Then Combined Exercises|Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
1145881|NCT00445224|O1|Outcome|Hip Strengthening Then Combined Exercises|Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
1145882|NCT00445224|E2|Reported Event|Quadricep Group Then Combined Exercises|Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
1145883|NCT00445224|E1|Reported Event|Hip Strengthening Then Combined Exercises|Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
1145884|NCT00445211|B3|Baseline|Total|Total of all reporting groups
1145885|NCT00445211|B2|Baseline|Intra-Aortic Balloon Pump Without Heparin|"Intra-Aortic balloon Pump (IABP) without Heparin~Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin."
1145886|NCT00445211|B1|Baseline|Intra-Aortic Balloon Pump With Heparin|"Intra-Aortic Balloon Pump (IABP) with Heparin~Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP)."
1145887|NCT00445211|P2|Participant Flow|Intra-Aortic Balloon Pump Without Heparin|"Intra-Aortic balloon Pump (IABP) without Heparin~Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin."
1145888|NCT00445211|P1|Participant Flow|Intra-Aortic Balloon Pump With Heparin|"Intra-Aortic Balloon Pump (IABP) with Heparin~Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP)."
1145889|NCT00445211|O2|Outcome|Intra-Aortic Balloon Pump Without Heparin|"Intra-Aortic balloon Pump (IABP) without Heparin~Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin."
1145890|NCT00445211|O1|Outcome|Intra-Aortic Balloon Pump With Heparin|"Intra-Aortic Balloon Pump (IABP) with Heparin~Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP)."
1145891|NCT00445211|O2|Outcome|Intra-Aortic Balloon Pump Without Heparin|"Intra-Aortic balloon Pump (IABP) without Heparin~Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin."
1145892|NCT00445211|O1|Outcome|Intra-Aortic Balloon Pump With Heparin|"Intra-Aortic Balloon Pump (IABP) with Heparin~Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP)."
1145893|NCT00445211|O2|Outcome|Intra-Aortic Balloon Pump Without Heparin|"Intra-Aortic balloon Pump (IABP) without Heparin~Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin."
1145894|NCT00445211|O1|Outcome|Intra-Aortic Balloon Pump With Heparin|"Intra-Aortic Balloon Pump (IABP) with Heparin~Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP)."
1145895|NCT00445211|O2|Outcome|Intra-Aortic Balloon Pump Without Heparin|"Intra-Aortic balloon Pump (IABP) without Heparin~Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin."
1145896|NCT00445211|O1|Outcome|Intra-Aortic Balloon Pump With Heparin|"Intra-Aortic Balloon Pump (IABP) with Heparin~Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP)."
1145897|NCT00445211|O2|Outcome|Intra-Aortic Balloon Pump Without Heparin|"Intra-Aortic balloon Pump (IABP) without Heparin~Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin."
1145931|NCT00445003|O2|Outcome|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
1145899|NCT00445211|E2|Reported Event|Intra-Aortic Balloon Pump Without Heparin|"Intra-Aortic balloon Pump (IABP) without Heparin~Without Heparin: Intra-Aortic balloon Pump (IABP) without Heparin."
1145900|NCT00445211|E1|Reported Event|Intra-Aortic Balloon Pump With Heparin|"Intra-Aortic Balloon Pump (IABP) with Heparin~Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP)."
1145901|NCT00445146|B1|Baseline|EVG+RTV|EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study. Some participants may have received EVG 300 mg during the course of protocol amendment 2.
1145902|NCT00445146|P1|Participant Flow|EVG+RTV|"Elvitegravir (EVG) 85 or 150 mg tablet boosted with ritonavir (RTV; r/) 100 mg capsule once daily with food in combination with an investigator-selected antiretroviral (ARV) regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
1145903|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
1145904|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
1145905|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
1145906|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
1145907|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
1145908|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
1145987|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
1145909|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
1145910|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
1145911|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
1145912|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
1145913|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
1145914|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
1145915|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
1145916|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
1145917|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
1145918|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
1145919|NCT00445146|E1|Reported Event|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule administered orally once daily with food in combination with an investigator-selected antiretroviral (ARV) regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
1145920|NCT00445003|B4|Baseline|Total|Total of all reporting groups
1145921|NCT00445003|B3|Baseline|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
1145922|NCT00445003|B2|Baseline|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
1145923|NCT00445003|B1|Baseline|Sham Injection|Sham injection at baseline and 4 weeks
1145924|NCT00445003|P3|Participant Flow|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
1145925|NCT00445003|P2|Participant Flow|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
1145926|NCT00445003|P1|Participant Flow|Sham Injection|Sham injection at baseline and 4 weeks
1145927|NCT00445003|O3|Outcome|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
1145928|NCT00445003|O2|Outcome|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
1145929|NCT00445003|O1|Outcome|Sham Injection|Sham injection at baseline and 4 weeks
1145935|NCT00445003|O1|Outcome|Sham Injection|Sham injection at baseline and 4 weeks
1145936|NCT00445003|O3|Outcome|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
1145937|NCT00445003|O2|Outcome|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
1145938|NCT00445003|O1|Outcome|Sham Injection|Sham injection at baseline and 4 weeks
1145939|NCT00445003|O3|Outcome|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
1145940|NCT00445003|O2|Outcome|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
1145941|NCT00445003|O1|Outcome|Sham Injection|Sham injection at baseline and 4 weeks
1145942|NCT00445003|O3|Outcome|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
1145943|NCT00445003|O2|Outcome|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
1145944|NCT00445003|O1|Outcome|Sham Injection|Sham injection at baseline and 4 weeks
1145945|NCT00445003|O3|Outcome|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
1145946|NCT00445003|O2|Outcome|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
1145947|NCT00445003|O1|Outcome|Sham Injection|Sham injection at baseline and 4 weeks
1145948|NCT00445003|O3|Outcome|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
1145949|NCT00445003|O2|Outcome|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
1145950|NCT00445003|O1|Outcome|Sham Injection|Sham injection at baseline and 4 weeks
1145951|NCT00445003|E3|Reported Event|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
1145952|NCT00445003|E2|Reported Event|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
1145953|NCT00445003|E1|Reported Event|Sham Injection|Sham injection at baseline and 4 weeks
1145954|NCT00444951|B4|Baseline|Total|Total of all reporting groups
1145955|NCT00444951|B3|Baseline|Control Group|Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
1147597|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
1145956|NCT00444951|B2|Baseline|Mencevax® Group|Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
1145957|NCT00444951|B1|Baseline|Menactra® Group|Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine.
1145958|NCT00444951|P3|Participant Flow|Control Group|Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
1145959|NCT00444951|P2|Participant Flow|Mencevax® Group|Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
1145960|NCT00444951|P1|Participant Flow|Menactra® Group|Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine.
1145961|NCT00444951|O3|Outcome|Control Group|Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
1145962|NCT00444951|O2|Outcome|Mencevax® Group|Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
1145963|NCT00444951|O1|Outcome|Menactra® Group|Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine.
1145964|NCT00444951|O3|Outcome|Control Group|Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
1145965|NCT00444951|O2|Outcome|Mencevax® Group|Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
1145966|NCT00444951|O1|Outcome|Menactra® Group|Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine.
1145967|NCT00444951|O3|Outcome|Control Group|Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
1145968|NCT00444951|O2|Outcome|Mencevax® Group|Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
1145969|NCT00444951|O1|Outcome|Menactra® Group|Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine.
1145970|NCT00444951|E3|Reported Event|Control Group|Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
1146014|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
1145971|NCT00444951|E2|Reported Event|Mencevax® Group|Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
1145972|NCT00444951|E1|Reported Event|Menactra® Group|Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine.
1145973|NCT00444925|B4|Baseline|Total|Total of all reporting groups
1145974|NCT00444925|B3|Baseline|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
1145975|NCT00444925|B2|Baseline|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
1145976|NCT00444925|B1|Baseline|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
1145977|NCT00444925|P3|Participant Flow|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
1145978|NCT00444925|P2|Participant Flow|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
1145979|NCT00444925|P1|Participant Flow|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
1145980|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
1145981|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
1145982|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
1145983|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
1145984|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
1145985|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
1145988|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
1145989|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
1145990|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
1145991|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
1145992|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
1145993|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
1145994|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
1145995|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
1145996|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
1145997|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
1145998|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
1145999|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
1146000|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
1146001|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
1146002|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
1146003|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
1146004|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
1146005|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
1146006|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
1146007|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
1146008|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
1146009|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
1146010|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
1146011|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
1146012|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
1146013|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
1156460|NCT00420992|E3|Reported Event|Titration ALO-01|Open-label ALO-01
1146015|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
1146016|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
1146017|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
1146018|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
1146019|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
1146020|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
1146021|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
1146022|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
1146023|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
1146024|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
1146025|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
1146026|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
1146027|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
1146028|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
1146029|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
1146030|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
1146031|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
1146032|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
1147598|NCT00441480|O2|Outcome|Control|Corn oil
1146033|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
1146034|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
1146035|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
1146036|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
1146037|NCT00444925|E3|Reported Event|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
1146038|NCT00444925|E2|Reported Event|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
1146039|NCT00444925|E1|Reported Event|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
1146040|NCT00444912|B3|Baseline|Total|Total of all reporting groups
1146041|NCT00444912|B2|Baseline|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
1146042|NCT00444912|B1|Baseline|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
1146043|NCT00444912|P2|Participant Flow|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
1146044|NCT00444912|P1|Participant Flow|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
1146045|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
1146046|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
1146047|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
1146048|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
1146049|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
1146050|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
1146051|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
1146052|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
1146053|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
1146054|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
1146055|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
1146056|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
1146057|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
1146058|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
1146059|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
1146060|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
1146061|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
1146062|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
1146063|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
1146064|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
1146065|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
1146066|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
1146067|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
1146068|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
1146069|NCT00444912|E2|Reported Event|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
1146070|NCT00444912|E1|Reported Event|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
1146071|NCT00444795|B1|Baseline|Sutene|Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
1146072|NCT00444795|P1|Participant Flow|Sutene|Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
1146073|NCT00444795|O1|Outcome|Sutene|Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
1146074|NCT00444795|O1|Outcome|Sutene|Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
1146200|NCT00444587|B2|Baseline|Only Chemotherapy|Eligible participants were administered second line chemotherapy according to the investigator’s decision.
1146075|NCT00444795|E1|Reported Event|Sutene|Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
1146076|NCT00444626|B1|Baseline|Combined Arms|Participants received DGE in one nasolabial fold (NLF) on one side of their face and Restylane in one NLF on the other side of their face (blinded, split-face study design) in the Initial Treatment. For participants who continued into the Repeat Treatment Period, they received DGE in both NLFs as an open-label treatment.
1146077|NCT00444626|P1|Participant Flow|Combined Arm|Participants received DGE in one nasolabial fold (NLF) on one side of their face and Restylane in one NLF on the other side of their face (blinded, split-face study design) in the Initial Treatment. For participants who continued into the Repeat Treatment Period, they received DGE in both NLFs as an open-label treatment.
1146078|NCT00444626|O3|Outcome|Non-NLF|Adverse events that did not occur at the nasolabial folds
1146079|NCT00444626|O2|Outcome|Restylane - Dermal Gel Extra (DGE)|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. In the Repeat Treatment Period, participants received DGE on both sides of their face. This represents the experience with DGE for the side of the face that was originally treated with Restylane.
1146080|NCT00444626|O1|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period, they received DGE in all NLFs as an open-label treatment.
1146081|NCT00444626|O3|Outcome|Non-NLF|Adverse events that did not occur at the nasolabial folds
1146082|NCT00444626|O2|Outcome|Restylane|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
1146083|NCT00444626|O1|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period, they received DGE in all NLFs as an open-label treatment.
1146084|NCT00444626|O2|Outcome|Restylane|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
1146085|NCT00444626|O1|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.
1146086|NCT00444626|O2|Outcome|Restylane|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
1146087|NCT00444626|O1|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.
1146088|NCT00444626|O2|Outcome|Restylane|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
1146089|NCT00444626|O1|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.
1146090|NCT00444626|O2|Outcome|Restylane|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
1146091|NCT00444626|O1|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.
1146092|NCT00444626|O2|Outcome|Restylane|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
1146093|NCT00444626|O1|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.
1146094|NCT00444626|O2|Outcome|Restylane|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
1146095|NCT00444626|O1|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.
1146096|NCT00444626|E6|Reported Event|Non-NLF: Repeat Treatment Period|Adverse events that did not occur at the nasolabial folds, and occurred during the Repeat Treatment Period regardless to relationship to DGE treatment.
1146097|NCT00444626|E5|Reported Event|Restylane - Dermal Gel Extra (DGE) - Repeat Treatment Period|Adverse events that occurred at the nasolabial fold that was treated with Restylane in the Initial Treatment Period, and occurred during the Repeat Treatment Period regardless of relationship to DGE treatment.
1146098|NCT00444626|E4|Reported Event|Dermal Gel Extra (DGE) - Repeat Treatment Period|Adverse events that occurred at the nasolabial fold that was treated with DGE in the Initial Treatment Period, and occurred during the Repeat Treatment Period regardless of relationship to DGE treatment.
1146099|NCT00444626|E3|Reported Event|Non-NLF: Initial Treatment Period|Adverse events that did not occur at the nasolabial folds, and occurred during the Initial Treatment Period regardless to relationship to either DGE or Restylane treatment.
1146100|NCT00444626|E2|Reported Event|Restylane: Initial Treatment Period|Adverse events that occurred at the nasolabial fold treated with Restylane, and occurred during the Initial Treatment Period regardless of relationship to Restylane treatment.
1146101|NCT00444626|E1|Reported Event|Dermal Gel Extra (DGE): Initial Treatment Period|Adverse events that occurred at the nasolabial fold treated with DGE, and occurred during the Initial Treatment Period regardless of relationship to DGE treatment.
1146102|NCT00444600|B5|Baseline|Total|Total of all reporting groups
1146103|NCT00444600|B4|Baseline|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146104|NCT00444600|B3|Baseline|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
1146105|NCT00444600|B2|Baseline|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146106|NCT00444600|B1|Baseline|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146107|NCT00444600|P4|Participant Flow|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146108|NCT00444600|P3|Participant Flow|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
1146109|NCT00444600|P2|Participant Flow|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146110|NCT00444600|P1|Participant Flow|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146111|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146112|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
1146113|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146114|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146115|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146116|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
1146318|NCT00444275|O5|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
1146319|NCT00444275|O4|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
1146117|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146118|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146119|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146120|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
1146121|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146122|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146123|NCT00444600|O3|Outcome|Triamcinolone|
1146124|NCT00444600|O2|Outcome|Ranibizumab|
1146125|NCT00444600|O1|Outcome|Sham|
1146126|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146127|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
1146128|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146129|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146130|NCT00444600|O3|Outcome|Triamcinolone|
1146131|NCT00444600|O2|Outcome|Ranibizumab|
1146132|NCT00444600|O1|Outcome|Sham|
1146133|NCT00444600|O3|Outcome|Triamcinolone|
1146134|NCT00444600|O2|Outcome|Ranibizumab|
1146135|NCT00444600|O1|Outcome|Sham|
1146136|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146137|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
1146138|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146139|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146140|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146141|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
1146142|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146143|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146144|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146145|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
1146146|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146320|NCT00444275|O3|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
1146321|NCT00444275|O2|Outcome|Esomeprazole 40 mg Once Daily (Initial Phase)|
1146147|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146148|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146149|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
1146150|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146151|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146152|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146153|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
1146154|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146228|NCT00444535|O1|Outcome|Lapatinib + Bevacizumab|Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
1146155|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146156|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146157|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
1146158|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146159|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146160|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146161|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
1146162|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146163|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146164|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146165|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
1146166|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146167|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146168|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146169|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
1146322|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Initial Phase)|
1146325|NCT00444275|O3|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
1146170|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146171|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146172|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146173|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
1146174|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146175|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146176|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146177|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
1146178|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146179|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146180|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146181|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
1146182|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146183|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146184|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146185|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
1146186|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146187|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146188|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146189|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
1146190|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146191|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
1146216|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
1146323|NCT00444275|O5|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
1146192|NCT00444600|E7|Reported Event|Sham + Triamcinolone + Laser|Participants in this group had 2 study eyes, the right eye was assigned randomly with equal probability to one of the four groups (Sham + prompt laser, ranibizumab + prompt laser, ranibizumab + deferred laser, triamcinolone + prompt laser). If the right eye was assigned to a treatment group other than the sham + prompt laser group, then the left eye was assigned to the sham + prompt laser group. If the right eye was assigned to the sham prompt + prompt laser group, then the left eye was assigned randomly to one of the other three groups.
1146193|NCT00444600|E6|Reported Event|Sham + Ranibizumab + Deferred Laser|Participants in this group had 2 study eyes, the right eye was assigned randomly with equal probability to one of the four groups (Sham + prompt laser, ranibizumab + prompt laser, ranibizumab + deferred laser, triamcinolone + prompt laser). If the right eye was assigned to a treatment group other than the sham + prompt laser group, then the left eye was assigned to the sham + prompt laser group. If the right eye was assigned to the sham prompt + prompt laser group, then the left eye was assigned randomly to one of the other three groups.
1146194|NCT00444600|E5|Reported Event|Sham + Ranibizumab + Laser|Participants in this group had 2 study eyes, the right eye was assigned randomly with equal probability to one of the four groups (Sham + prompt laser, ranibizumab + prompt laser, ranibizumab + deferred laser, triamcinolone + prompt laser). If the right eye was assigned to a treatment group other than the sham + prompt laser group, then the left eye was assigned to the sham + prompt laser group. If the right eye was assigned to the sham prompt + prompt laser group, then the left eye was assigned randomly to one of the other three groups.
1146195|NCT00444600|E4|Reported Event|Triamcinolone + Prompt Laser|4 mg intravitreal triamcinolone plus prompt (within 3–10 days after injection) focal/grid photocoagulation
1146196|NCT00444600|E3|Reported Event|Ranibizumab + Deferred Laser|0.5 mg intravitreal ranibizumab with deferred (24 weeks) focal/grid photocoagulation
1146197|NCT00444600|E2|Reported Event|Ranibizumab + Prompt Laser|0.5 mg intravitreal ranibizumab plus prompt (within 3–10 days after injection) focal/grid photocoagulation
1146198|NCT00444600|E1|Reported Event|Sham + Prompt Laser|Laser was given within 3 to 10 days after sham injections, Laser = Focal/grid photocoagulation
1146199|NCT00444587|B3|Baseline|Total|Total of all reporting groups
1146201|NCT00444587|B1|Baseline|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), IV infusion, every three weeks until disease progression, unacceptable toxicities, or withdrawal from study in combination with second line chemotherapy.
1146202|NCT00444587|P2|Participant Flow|Only Chemotherapy|Eligible participants were administered second line chemotherapy according to the investigator’s decision.
1146203|NCT00444587|P1|Participant Flow|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab (Herceptin) 6 milligrams per kilograms (mg/kg) of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous (IV) infusion every three weeks until disease progression, unacceptable toxicities, or withdrawal from study, in combination with second line chemotherapy.
1146204|NCT00444587|O2|Outcome|Only Chemotherapy|Eligible participants received second line chemotherapy according to the investigator's decision.
1146205|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
1146206|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
1146207|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
1146208|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
1146209|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
1146210|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
1146211|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
1146212|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
1146213|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
1146214|NCT00444587|O2|Outcome|Only Chemotherapy|Eligible participants were administered second line chemotherapy according to the investigator’s decision.
1146215|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
1146304|NCT00444275|P4|Participant Flow|Esomeprazole 20 mg on Demand (Maintenance Phase)|
1156461|NCT00420992|E2|Reported Event|Placebo|
1146217|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
1146218|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
1146219|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
1146220|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), IV infusion, every three weeks until disease progression, unacceptable toxicities, or withdrawal from study in combination with second line chemotherapy.
1146221|NCT00444587|E2|Reported Event|Only Chemotherapy|Eligible participants were administered second line chemotherapy according to the investigator’s decision.
1146222|NCT00444587|E1|Reported Event|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), IV infusion, every three weeks until disease progression, unacceptable toxicities, or withdrawal from study in combination with second line chemotherapy.
1146223|NCT00444535|B1|Baseline|Lapatinib + Bevacizumab|Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
1146224|NCT00444535|P1|Participant Flow|Lapatinib + Bevacizumab|Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
1146225|NCT00444535|O1|Outcome|Lapatinib + Bevacizumab|Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
1146226|NCT00444535|O1|Outcome|Lapatinib + Bevacizumab|Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
1146227|NCT00444535|O1|Outcome|Lapatinib + Bevacizumab|Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
1146229|NCT00444535|E1|Reported Event|Lapatinib + Bevacizumab|Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
1146230|NCT00444457|B5|Baseline|Total|Total of all reporting groups
1146231|NCT00444457|B4|Baseline|7vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146232|NCT00444457|B3|Baseline|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146233|NCT00444457|B2|Baseline|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146234|NCT00444457|B1|Baseline|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146235|NCT00444457|P4|Participant Flow|7vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146305|NCT00444275|P3|Participant Flow|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
1146306|NCT00444275|P2|Participant Flow|Esomeprazole 40 mg Once Daily (Initial Phase)|
1156462|NCT00420992|E1|Reported Event|ALO-01|
1146236|NCT00444457|P3|Participant Flow|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146237|NCT00444457|P2|Participant Flow|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146238|NCT00444457|P1|Participant Flow|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146338|NCT00444275|O5|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
1146339|NCT00444275|O4|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
1146340|NCT00444275|O3|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
1146341|NCT00444275|O2|Outcome|Esomeprazole 40 mg Once Daily (Initial Phase)|
1146239|NCT00444457|O2|Outcome|7vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146240|NCT00444457|O1|Outcome|Combined 13vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146241|NCT00444457|O4|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
1146242|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
1146243|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
1146244|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
1146245|NCT00444457|O4|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
1146246|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
1146307|NCT00444275|P1|Participant Flow|Esomeprazole 20 mg Once Daily (Initial Phase)|
1146308|NCT00444275|O5|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
1146247|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
1146248|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
1146249|NCT00444457|O4|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
1146250|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
1146342|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Initial Phase)|
1146343|NCT00444275|O5|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
1146344|NCT00444275|O4|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
1146345|NCT00444275|O3|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
1146251|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
1146252|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
1146253|NCT00444457|O2|Outcome|7vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146254|NCT00444457|O1|Outcome|Combined 13vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146255|NCT00444457|O4|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
1146256|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
1146257|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
1146258|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
1146259|NCT00444457|O4|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
1146309|NCT00444275|O4|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
1146310|NCT00444275|O3|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
1146260|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
1146261|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
1146262|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
1146263|NCT00444457|O4|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
1146264|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
1146265|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
1146266|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
1146267|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146268|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146269|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146270|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146311|NCT00444275|O2|Outcome|Esomeprazole 40 mg Once Daily (Initial Phase)|
1146312|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Initial Phase)|
1146313|NCT00444275|O5|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
1146314|NCT00444275|O4|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
1146315|NCT00444275|O3|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
1146271|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146272|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146346|NCT00444275|O2|Outcome|Esomeprazole 40 mg Once Daily (Initial Phase)|
1146347|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Initial Phase)|
1146348|NCT00444275|O3|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
1146349|NCT00444275|O2|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
1146273|NCT00444457|O1|Outcome|Combined 13vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146274|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146275|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146276|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146277|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146278|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146279|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146316|NCT00444275|O2|Outcome|Esomeprazole 40 mg Once Daily (Initial Phase)|
1156463|NCT00420927|B8|Baseline|Total|Total of all reporting groups
1146280|NCT00444457|O2|Outcome|7vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146281|NCT00444457|O1|Outcome|Combined 13vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146282|NCT00444457|O2|Outcome|7vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146283|NCT00444457|O1|Outcome|Combined 13vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146284|NCT00444457|O2|Outcome|7vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146285|NCT00444457|O1|Outcome|Combined 13vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146286|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146287|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146288|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
1146317|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Initial Phase)|
1146324|NCT00444275|O4|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
1146289|NCT00444457|E10|Reported Event|Post Toddler Dose 6-Month Follow-up 7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose) ; co-administered with a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose).
1146290|NCT00444457|E9|Reported Event|Post Toddler Dose 6-Month Follow-up Combined 13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1, 2, or manufacturing lot at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose) ; co-administered with a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose).
1146350|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
1146351|NCT00444275|E5|Reported Event|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
1146291|NCT00444457|E8|Reported Event|Toddler Dose 7vPnC|"Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age; co-administered with a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=75; systematic (solicited) Local Reactions N=83; systematic (solicited) Systemic Events N=128."
1146292|NCT00444457|E7|Reported Event|Toddler Dose Combined 13vPnC|"Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1, 2, or manufacturing lot at 12 months of age; co-administered with a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=434; systematic (solicited) Local Reactions N=473; systematic (solicited) Systemic Events N=771."
1146293|NCT00444457|E6|Reported Event|After the Infant Series 7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (assessment at 7 months of age; 1 month after the infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age(assessment at 7 months of age; 1 month after the infant series).
1146294|NCT00444457|E5|Reported Event|After the Infant Series Combined 13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1, 2, or manufacturing lot at 2, 4, and 6 months of age (assessment at 7 months of age; 1 month after the infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age(assessment at 7 months of age; 1 month after the infant series).
1146295|NCT00444457|E4|Reported Event|Infant Series 7vPnC|"Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=207; systematic (solicited) Local Reactions N=142; systematic (solicited) Systemic Events N=198."
1146296|NCT00444457|E3|Reported Event|Infant Series 13vPnC (Manufacturing Lot)|"Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=402; systematic (solicited) Local Reactions N=250; systematic (solicited) Systemic Events N=386."
1146297|NCT00444457|E2|Reported Event|Infant Series 13vPnC (Pilot Lot 2)|"Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=394; systematic (solicited) Local Reactions N=262; systematic (solicited) Systemic Events N=364."
1146298|NCT00444457|E1|Reported Event|Infant Series 13vPnC (Pilot Lot 1)|"Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=407; systematic (solicited) Local Reactions N=262; systematic (solicited) Systemic Events N=373."
1146299|NCT00444275|B4|Baseline|Total|Total of all reporting groups
1146300|NCT00444275|B3|Baseline|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
1146301|NCT00444275|B2|Baseline|Esomeprazole 20 mg on Demand (Maintenance Phase)|
1146302|NCT00444275|B1|Baseline|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
1146303|NCT00444275|P5|Participant Flow|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
1146326|NCT00444275|O2|Outcome|Esomeprazole 40 mg Once Daily (Initial Phase)|
1146327|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Initial Phase)|
1146328|NCT00444275|O5|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
1146329|NCT00444275|O4|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
1146330|NCT00444275|O3|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
1146331|NCT00444275|O2|Outcome|Esomeprazole 40 mg Once Daily (Initial Phase)|
1146332|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Initial Phase)|
1146333|NCT00444275|O5|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
1146334|NCT00444275|O4|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
1146335|NCT00444275|O3|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
1146336|NCT00444275|O2|Outcome|Esomeprazole 40 mg Once Daily (Initial Phase)|
1146337|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Initial Phase)|
1146356|NCT00444145|B1|Baseline|Patients Receiving Prevacid|"Patients who have documented GERD as evidenced by erosive esophagitis or those patients who have newly diagnosed laryngopharyngeal reflux as diagnosed by endoscopy.~Prevacid: 30 mg bid for 3 months~Esophageal and Laryngeal Biopsies: repeat egd with biopsy"
1146357|NCT00444145|P1|Participant Flow|Patients Receiving Prevacid|"Patients who have documented GERD as evidenced by erosive esophagitis or those patients who have newly diagnosed laryngopharyngeal reflux as diagnosed by endoscopy.~Prevacid: 30 mg bid for 3 months~Esophageal and Laryngeal Biopsies: repeat egd with biopsy"
1146358|NCT00444145|O1|Outcome|Patients Receiving Prevacid|"Patients who have documented GERD as evidenced by erosive esophagitis or those patients who have newly diagnosed laryngopharyngeal reflux as diagnosed by endoscopy.~Prevacid: 30 mg bid for 3 months~Esophageal and Laryngeal Biopsies: repeat egd with biopsy"
1146359|NCT00444145|E1|Reported Event|Patients Receiving Prevacid|"Patients who have documented GERD as evidenced by erosive esophagitis or those patients who have newly diagnosed laryngopharyngeal reflux as diagnosed by endoscopy.~Prevacid: 30 mg bid for 3 months~Esophageal and Laryngeal Biopsies: repeat egd with biopsy"
1146360|NCT00444106|B4|Baseline|Total|Total of all reporting groups
1146361|NCT00444106|B3|Baseline|Artesunate-mefloquine|Artesunate (Plasmotrim) 50 mg tablet; based on body weight for a dosage of 4 mg/kg/day for 3 days- mefloquine (Mephaquin) 250 mg tablets; based on body weight for a total dosage of 25 mg/kg once daily on days 2 and 3.
1146362|NCT00444106|B2|Baseline|Atovaquone-proguanil (Malarone)|Atovaquone-proguanil (Malarone) tablets containing 250 mg atovaquone and 100 mg proguanil hydrochloride once daily for 3 days dosage dependent on body weight.
1146363|NCT00444106|B1|Baseline|Artemether-lumefantrine (Coartem)|Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.
1146364|NCT00444106|P3|Participant Flow|Artesunate-mefloquine|Artesunate (Plasmotrim) 50 mg tablet; based on body weight for a dosage of 4 mg/kg/day for 3 days- mefloquine (Mephaquin) 250 mg tablets; based on body weight for a total dosage of 25 mg/kg once daily on days 2 and 3.
1146365|NCT00444106|P2|Participant Flow|Atovaquone-proguanil (Malarone)|Atovaquone-proguanil (Malarone) tablets containing 250 mg atovaquone and 100 mg proguanil hydrochloride once daily for 3 days dosage dependent on body weight.
1146366|NCT00444106|P1|Participant Flow|Artemether-lumefantrine (Coartem)|Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.
1146367|NCT00444106|O3|Outcome|Artesunate-mefloquine|Artesunate (Plasmotrim) 50 mg tablet; based on body weight for a dosage of 4 mg/kg/day for 3 days- mefloquine (Mephaquin)250 mg tablets; based on body weight for a total dosage of 25 mg/kg once daily on days 2 and 3.
1146368|NCT00444106|O2|Outcome|Atovaquone-proguanil (Malarone)|Atovaquone-proguanil (Malarone) 250mg tablets once daily for 3 days dosage dependent on body weight.
1146369|NCT00444106|O1|Outcome|Artemether-lumefantrine (Coartem)|Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.
1146370|NCT00444106|O3|Outcome|Artesunate-mefloquine|Artesunate (Plasmotrim) 50 mg tablet; based on body weight for a dosage of 4 mg/kg/day for 3 days- mefloquine (Mephaquin) 250 mg tablets; based on body weight for a total dosage of 25 mg/kg once daily on days 2 and 3.
1146371|NCT00444106|O2|Outcome|Atovaquone-proguanil (Malarone)|Atovaquone-proguanil (Malarone) tablets containing 250 mg atovaquone and 100 mg proguanil hydrochloride once daily for 3 days dosage dependent on body weight.
1146372|NCT00444106|O1|Outcome|Artemether-lumefantrine (Coartem)|Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.
1146373|NCT00444106|O3|Outcome|Artesunate-mefloquine|Artesunate (Plasmotrim) 50 mg tablet; based on body weight for a dosage of 4 mg/kg/day for 3 days- mefloquine (Mephaquin)250 mg tablets; based on body weight for a total dosage of 25 mg/kg once daily on days 2 and 3.
1146374|NCT00444106|O2|Outcome|Atovaquone-proguanil (Malarone)|Atovaquone-proguanil (Malarone) 250mg tablets once daily for 3 days dosage dependent on body weight.
1146375|NCT00444106|O1|Outcome|Artemether-lumefantrine|Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.
1146376|NCT00444106|O1|Outcome|Artemether-lumefantrine (Coartem)|Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.
1146377|NCT00444106|E3|Reported Event|Artesunate-Mefloquine|Artesunate-Mefloquine
1146378|NCT00444106|E2|Reported Event|Atovaquone-proguanil|Atovaquone-proguanil
1146379|NCT00444106|E1|Reported Event|Artemether-lumefantrine|Artemether-lumefantrine
1146380|NCT00444067|B3|Baseline|Total|Total of all reporting groups
1146381|NCT00444067|B2|Baseline|Control|Standard of care methods used as an adjunct to sutured dural repair.
1146382|NCT00444067|B1|Baseline|Spinal Sealant|DuraSeal Spinal Sealant System
1146383|NCT00444067|P2|Participant Flow|Control|Standard of care methods used as an adjunct to sutured dural repair.
1146384|NCT00444067|P1|Participant Flow|Spinal Sealant|DuraSeal Spinal Sealant System
1146385|NCT00444067|O2|Outcome|Control|Standard of care methods used as an adjunct to sutured dural repair.
1146386|NCT00444067|O1|Outcome|Spinal Sealant|DuraSeal Spinal Sealant System
1146387|NCT00444067|O2|Outcome|Control|Standard of care methods used as an adjunct to sutured dural repair.
1146388|NCT00444067|O1|Outcome|Spinal Sealant|DuraSeal Spinal Sealant System
1146389|NCT00444067|O2|Outcome|Control|Standard of care methods used as an adjunct to sutured dural repair.
1146390|NCT00444067|O1|Outcome|Spinal Sealant|DuraSeal Spinal Sealant System
1146391|NCT00444067|E2|Reported Event|Control|Standard of care methods used as an adjunct to sutured dural repair.
1146392|NCT00444067|E1|Reported Event|Spinal Sealant|DuraSeal Spinal Sealant System
1146393|NCT00443898|B5|Baseline|Total|Total of all reporting groups
1146394|NCT00443898|B4|Baseline|Vehicle 48 w|vehicle (placebo) applied once daily for 48 weeks
1146395|NCT00443898|B3|Baseline|Terbinafine 48 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
1146396|NCT00443898|B2|Baseline|Vehicle 24 w|vehicle (placebo) applied once daily for 24 weeks
1146397|NCT00443898|B1|Baseline|Terbinafine 24 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
1146398|NCT00443898|P4|Participant Flow|Vehicle 48 w|vehicle (placebo) applied once daily for 48 weeks
1146399|NCT00443898|P3|Participant Flow|Terbinafine 48 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
1146400|NCT00443898|P2|Participant Flow|Vehicle 24 w|vehicle (placebo) applied once daily for 24 weeks
1146401|NCT00443898|P1|Participant Flow|Terbinafine 24 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
1146402|NCT00443898|O4|Outcome|Vehicle 48 w|vehicle (placebo) applied once daily for 48 weeks
1146403|NCT00443898|O3|Outcome|Terbinafine 48 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
1146404|NCT00443898|O2|Outcome|Vehicle 24 w|vehicle (placebo) applied once daily for 24 weeks
1146405|NCT00443898|O1|Outcome|Terbinafine 24 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
1146406|NCT00443898|O4|Outcome|Vehicle 48 w|vehicle (placebo) applied once daily for 48 weeks
1146407|NCT00443898|O3|Outcome|Terbinafine 48 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
1146408|NCT00443898|O2|Outcome|Vehicle 24 w|vehicle (placebo) applied once daily for 24 weeks
1146409|NCT00443898|O1|Outcome|Terbinafine 24 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
1146410|NCT00443898|O4|Outcome|Vehicle 48 w|vehicle (placebo) applied once daily for 48 weeks
1146411|NCT00443898|O3|Outcome|Terbinafine 48 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
1146412|NCT00443898|O2|Outcome|Vehicle 24 w|vehicle (placebo) applied once daily for 24 weeks
1146413|NCT00443898|O1|Outcome|Terbinafine 24 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
1146414|NCT00443898|O4|Outcome|Vehicle 48 w|vehicle (placebo) applied once daily for 48 weeks
1146415|NCT00443898|O3|Outcome|Terbinafine 48 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
1146416|NCT00443898|O2|Outcome|Vehicle 24 w|vehicle (placebo) applied once daily for 24 weeks
1146417|NCT00443898|O1|Outcome|Terbinafine 24 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
1146418|NCT00443898|E4|Reported Event|Vehicle 48 w|vehicle (placebo) applied once daily for 48 weeks
1146419|NCT00443898|E3|Reported Event|Terbinafine 48 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
1146420|NCT00443898|E2|Reported Event|Vehicle 24 w|vehicle (placebo) applied once daily for 24 weeks
1146421|NCT00443898|E1|Reported Event|Terbinafine 24 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
1146422|NCT00443872|B1|Baseline|PD Patients With DA Related AE|This is a one arm open label study of PD patients with a DA related AE
1146423|NCT00443872|P1|Participant Flow|PD Patients With DA Related AE|This is a one arm open label study of PD patients with a DA related AE
1146764|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
1146424|NCT00443872|O1|Outcome|All PD Patients With DA Related AEs (MMSE)|All patients had a DA related AE and received 1.25 mg once daily orally disintegrating selegiline which was increased after 6 weeks to 2.5mg once daily if tolerated.
1146425|NCT00443872|O1|Outcome|All PD Patients With DA Related AEs (BAI)|All patients had a DA related AE and received 1.25 mg once daily orally disintegrating selegiline which was increased after 6 weeks to 2.5mg once daily if tolerated.
1146426|NCT00443872|O1|Outcome|All PD Patients With DA Related AEs (BDI)|All patients had a DA related AE and received 1.25 mg once daily orally disintegrating selegiline which was increased after 6 weeks to 2.5mg once daily if tolerated.
1146427|NCT00443872|O1|Outcome|All Subjects PDQ-39|This includes all patients in the study. They all received 1.25 mg once daily of orally disintegrating selegiline for 6 weeks which was increased to 2.5 mg once daily if tolerated.
1146428|NCT00443872|O1|Outcome|All Subjects With DA Related AEs (UPDRS Data)|For all completed subjects (60) UPDRS activities of daily living scores and motor scores were collected. All patients received 1.25 mg once daily orally disintegrating selegiline for 6 weeks which was increased to 2.5mg once daily at 12 weeks if tolerated.
1146429|NCT00443872|O1|Outcome|PD Patients With DA Related AE (Impulse Control Disorder)|Patients who are experiencing dopamine agonist (DA) related adverse effect (AE) of impulse control disorder (ICD) received 1.25 mg once daily of orally disintegrating selegiline for 6 weeks after which it was increased to 2.5mg once daily if tolerated.
1146430|NCT00443872|O1|Outcome|PD Patiens With DA Related AE (Pedal Edema)|Patients who are experiencing a dopamine agonist (DA) related AE of pedal edema received 1.25mg once daily of orally disintegrating selegiline for 6 weeks after which there was an increase to 2.5 mg once daily if tolerated.
1146431|NCT00443872|O1|Outcome|PD Patients With DA Related AE (Hallucinations)|Patients who are experiencing the dopamine agonist (DA) related adverse effect of hallucinations. The participants received 1.25 mg once daily of orally disintegrating selegiline for 6 weeks after which it was increased to 2.5 mg once daily if tolerated.
1146432|NCT00443872|O1|Outcome|PD Patients With DA Related AE (Daytime Sleepiness)|Patients who are experiencing a dopamine agonist (DA) related adverse effect (AE) of daytime sleepiness received 1.25 mg once daily of orally disintegrating selegiline for 6 weeks with an increase to 2.5 mg once daily orally disintegrating selegiline for the remaining 6 weeks if tolerated.
1146433|NCT00443872|O1|Outcome|PD Patients With DA Related AE|Patients who are experiencing a dopamine agonist (DA) related adverse effect (AE) of either one or more of the following: excessive daytime sleepiness, hallucinations, pedal edema, impulse control disorder, received 1.25 mg once daily orally disintegrating selegiline for 6 weeks with an increase to 2.5 mg once daily orally disintegrating selegiline for remaining 6 weeks if tolerated.
1146434|NCT00443872|E1|Reported Event|PD Patients With DA Related AE|This is a one arm open label study of PD patients with a DA related AE
1146435|NCT00443820|B5|Baseline|Total|Total of all reporting groups
1146437|NCT00443820|B3|Baseline|Terbinafine 48 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
1146438|NCT00443820|B2|Baseline|Vehicle 24 Weeks|Vehicle (placebo) for 24 weeks
1146439|NCT00443820|B1|Baseline|Terbinafine 24 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
1146440|NCT00443820|P4|Participant Flow|Vehicle 48 Weeks|Vehicle (placebo) for 48 weeks
1146441|NCT00443820|P3|Participant Flow|Terbinafine 48 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
1146442|NCT00443820|P2|Participant Flow|Vehicle 24 Weeks|Vehicle (placebo) for 24 weeks
1146443|NCT00443820|P1|Participant Flow|Terbinafine 24 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
1146444|NCT00443820|O4|Outcome|Vehicle 48 Weeks|Vehicle (placebo) for 48 weeks
1146445|NCT00443820|O3|Outcome|Terbinafine 48 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
1146446|NCT00443820|O2|Outcome|Vehicle 24 Weeks|Vehicle (placebo) for 24 weeks
1146447|NCT00443820|O1|Outcome|Terbinafine 24 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
1146448|NCT00443820|O4|Outcome|Vehicle 48 Weeks|Vehicle (placebo) for 48 weeks
1146449|NCT00443820|O3|Outcome|Terbinafine 48 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
1146450|NCT00443820|O2|Outcome|Vehicle 24 Weeks|Vehicle (placebo) for 24 weeks
1146451|NCT00443820|O1|Outcome|Terbinafine 24 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
1146452|NCT00443820|O4|Outcome|Vehicle 48 Weeks|Vehicle (placebo) for 48 weeks
1146453|NCT00443820|O3|Outcome|Terbinafine 48 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
1146454|NCT00443820|O2|Outcome|Vehicle 24 Weeks|Vehicle (placebo) for 24 weeks
1146455|NCT00443820|O1|Outcome|Terbinafine 24 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
1146456|NCT00443820|O4|Outcome|Vehicle 48 Weeks|Vehicle (placebo) for 48 weeks
1146457|NCT00443820|O3|Outcome|Terbinafine 48 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
1146458|NCT00443820|O2|Outcome|Vehicle 24 Weeks|Vehicle (placebo) for 24 weeks
1146459|NCT00443820|O1|Outcome|Terbinafine 24 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
1146460|NCT00443820|E4|Reported Event|Vehicle 48 Weeks|Vehicle (placebo) for 48 weeks
1146461|NCT00443820|E3|Reported Event|Terbinafine 48 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
1146462|NCT00443820|E2|Reported Event|Vehicle 24 Weeks|Vehicle (placebo) for 24 weeks
1146463|NCT00443820|E1|Reported Event|Terbinafine 24 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
1146464|NCT00443781|B1|Baseline|PD and F.A.D. Diagnostic Testing|Subjects with chronic axial low back pain with suspected degenerative disc disease underwent provocative discography(PD)followed by Functional Anaesthetic Discography (F.A.D.)as part of a pilot, multicenter, prospective, single-arm diagnostic study.
1146765|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|subjects allocate to SIB Without PEEP valve
1156700|NCT00420017|B1|Baseline|Amiodarone|Intravenous amiodarone
1146465|NCT00443781|P1|Participant Flow|PD and F.A.D. Diagnostic Testing|Subjects with chronic axial low back pain with suspected degenerative disc disease underwent provocative discography(PD)followed by Functional Anaesthetic Discography (F.A.D.)as part of a pilot, multicenter, prospective, single-arm diagnostic study.
1146466|NCT00443781|O1|Outcome|PD and F.A.D. Diagnostic Testing|Subjects with chronic axial low back pain with suspected degenerative disc disease underwent provocative discography(PD)followed by Functional Anaesthetic Discography (F.A.D.)as part of a pilot, multicenter, prospective, single-arm diagnostic study.
1146467|NCT00443781|E1|Reported Event|PD and F.A.D. Diagnostic Testing|Subjects with chronic axial low back pain with suspected degenerative disc disease underwent provocative discography(PD)followed by Functional Anaesthetic Discography (F.A.D.)as part of a pilot, multicenter, prospective, single-arm diagnostic study.
1146468|NCT00443755|B3|Baseline|Total|Total of all reporting groups
1146469|NCT00443755|B2|Baseline|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
1146470|NCT00443755|B1|Baseline|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
1146471|NCT00443755|P2|Participant Flow|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
1146472|NCT00443755|P1|Participant Flow|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
1146473|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
1146474|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
1146475|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
1146476|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
1147599|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
1146477|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
1146478|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
1146479|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
1146480|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
1146481|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
1146482|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
1146483|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
1146484|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
1146485|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
1146486|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
1146487|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
1146488|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
1146489|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
1146490|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
1146766|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to SIB with PEEP valve
1146491|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
1146492|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
1146493|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
1146494|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
1146495|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
1146496|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
1146497|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
1146498|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
1146499|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
1146500|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
1146501|NCT00443755|E2|Reported Event|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
1146502|NCT00443755|E1|Reported Event|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
1146504|NCT00443729|B2|Baseline|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146505|NCT00443729|B1|Baseline|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146506|NCT00443729|P2|Participant Flow|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146507|NCT00443729|P1|Participant Flow|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146508|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146509|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146510|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146511|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146512|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146513|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146514|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146767|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
1146515|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146516|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146517|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146518|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146519|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146520|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146521|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146522|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146523|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146524|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146525|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146526|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146527|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146528|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146529|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146530|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146531|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146532|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146533|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146534|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146535|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146768|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|subjects allocated to SIB-Without PEEP valve
1146536|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146537|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146538|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146539|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146540|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146541|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146542|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146543|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146544|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146545|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146546|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146547|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146548|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146549|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146550|NCT00443729|E2|Reported Event|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146551|NCT00443729|E1|Reported Event|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146552|NCT00443703|B3|Baseline|Total|Total of all reporting groups
1146553|NCT00443703|B2|Baseline|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146554|NCT00443703|B1|Baseline|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146555|NCT00443703|P2|Participant Flow|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146556|NCT00443703|P1|Participant Flow|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146557|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146558|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146559|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146560|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146561|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146562|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146563|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146564|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146565|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146566|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146567|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146568|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146569|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146570|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146571|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146572|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146573|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146574|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146575|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146576|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146577|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146578|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146769|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with PEEP valve
1146579|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146580|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146581|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146582|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146583|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146584|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146585|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146586|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146587|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146588|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146589|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146590|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146591|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146592|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146593|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146594|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146595|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146596|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146597|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146598|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146599|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146770|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
1146600|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146601|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146602|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146603|NCT00443703|E2|Reported Event|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146604|NCT00443703|E1|Reported Event|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
1146605|NCT00443651|B3|Baseline|Total|Total of all reporting groups
1146606|NCT00443651|B2|Baseline|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
1146607|NCT00443651|B1|Baseline|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
1146640|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.~Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
1147600|NCT00441480|O2|Outcome|Control|Corn oil
1146608|NCT00443651|P2|Participant Flow|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
1146609|NCT00443651|P1|Participant Flow|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
1146610|NCT00443651|O2|Outcome|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
1146611|NCT00443651|O1|Outcome|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
1146612|NCT00443651|O2|Outcome|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
1146613|NCT00443651|O1|Outcome|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
1146614|NCT00443651|O2|Outcome|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
1146630|NCT00443599|P1|Participant Flow|Tight Glycemic Control|Insulin : Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter.
1146615|NCT00443651|O1|Outcome|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
1146616|NCT00443651|O2|Outcome|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
1146617|NCT00443651|O1|Outcome|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
1146618|NCT00443651|O2|Outcome|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
1146619|NCT00443651|O1|Outcome|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
1146794|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
1146620|NCT00443651|O2|Outcome|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
1146621|NCT00443651|O1|Outcome|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
1146622|NCT00443651|O2|Outcome|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
1146623|NCT00443651|O1|Outcome|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
1146624|NCT00443651|E2|Reported Event|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
1146625|NCT00443651|E1|Reported Event|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
1146626|NCT00443599|B3|Baseline|Total|Total of all reporting groups
1146627|NCT00443599|B2|Baseline|Standard Care|Usual Care : Participants receive standard Cardiac ICU care without tight blood glucose control.
1146628|NCT00443599|B1|Baseline|Tight Glycemic Control|Insulin : Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter.
1146629|NCT00443599|P2|Participant Flow|Standard Care|Usual Care : Participants receive standard Cardiac ICU care without tight blood glucose control.
1146631|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.~Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
1156701|NCT00420017|P2|Participant Flow|Control|Control usual care
1146632|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.~Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
1146633|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.~Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
1146634|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.~Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
1146635|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.~Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
1146636|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.~Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
1146637|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.~Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
1146638|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.~Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
1146639|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.~Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
1149032|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
1146641|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.~Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
1146642|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.~Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
1146643|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.~Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
1146644|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.~Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
1146645|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.~Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
1146646|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.~Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
1146647|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.~Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
1146648|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.~Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
1146649|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.~Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
1146650|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.~Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
1146651|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.~Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
1146652|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.~Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
1146653|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.~Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
1146654|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.~Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
1146655|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.~Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
1146656|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.~Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
1146657|NCT00443599|O2|Outcome|Standard Care|"Insulin was infused according to the discretion of the treating clinical team.~Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control."
1146658|NCT00443599|O1|Outcome|Tight Glycemic Control|"Insulin was infused to target a blood glucose concentration of 80-110 mg/dL.~Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter."
1146659|NCT00443599|E2|Reported Event|Usual Care|Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control.
1146660|NCT00443599|E1|Reported Event|Insulin|Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter.
1146661|NCT00443560|B3|Baseline|Total|Total of all reporting groups
1146662|NCT00443560|B2|Baseline|Spontaneous Vaginal Delivery (SVD)|The control group consisted of parturients who had a spontaneous vaginal delivery (SVD)in the same 24 hour period who were case-matched for gravidity and parity.
1146663|NCT00443560|B1|Baseline|Instrumental Vaginal Delivery (IVD)|Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
1149033|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
1146664|NCT00443560|P2|Participant Flow|Spontaneous Vaginal Delivery (SVD)|The control group consisted of parturients who had a spontaneous vaginal delivery (SVD)in the same 24 hour period who were case-matched for gravidity and parity.
1146665|NCT00443560|P1|Participant Flow|Instrumental Vaginal Delivery (IVD)|Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
1146666|NCT00443560|O2|Outcome|Spontaneous Vaginal Delivery (SVD)|The control group consisted of parturients who had a spontaneous vaginal delivery (SVD)in the same 24 hour period who were case-matched for gravidity and parity.
1146667|NCT00443560|O1|Outcome|Instrumental Vaginal Delivery (IVD)|Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
1146668|NCT00443560|O2|Outcome|Spontaneous Vaginal Delivery (SVD)|The control group consisted of parturients who had a spontaneous vaginal delivery (SVD)in the same 24 hour period who were case-matched for gravidity and parity.
1146669|NCT00443560|O1|Outcome|Instrumental Vaginal Delivery (IVD)|Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
1146670|NCT00443560|O2|Outcome|Spontaneous Vaginal Delivery (SVD)|The control group consisted of parturients who had a spontaneous vaginal delivery (SVD)in the same 24 hour period who were case-matched for gravidity and parity.
1146671|NCT00443560|O1|Outcome|Instrumental Vaginal Delivery (IVD)|Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
1146672|NCT00443560|E2|Reported Event|Spontaneous Vaginal Delivery (SVD)|The control group consisted of parturients who had a spontaneous vaginal delivery (SVD)in the same 24 hour period who were case-matched for gravidity and parity.
1146673|NCT00443560|E1|Reported Event|Instrumental Vaginal Delivery (IVD)|Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
1146674|NCT00443534|B1|Baseline|Sunitinib|Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
1146675|NCT00443534|P1|Participant Flow|Sunitinib|Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
1146676|NCT00443534|O1|Outcome|Sunitinib|Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
1146705|NCT00443456|O2|Outcome|The Preceding Study 5 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
1146771|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|subjects allocated to SIB-Without PEEP valve
1146677|NCT00443534|O1|Outcome|Sunitinib|Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
1146678|NCT00443534|O1|Outcome|Sunitinib|Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
1146679|NCT00443534|O1|Outcome|Sunitinib|Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
1146680|NCT00443534|E1|Reported Event|Sunitinib|Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
1146681|NCT00443456|B1|Baseline|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study.
1146682|NCT00443456|P1|Participant Flow|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study.
1146683|NCT00443456|O2|Outcome|Subjects Without Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who did not use concomitant antihypertensive agent during this long-term study (A0531086: NCT00443456).
1146684|NCT00443456|O1|Outcome|Subjects With Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who were treated with concomitant antihypertensive agent at Week 12 or later.
1146685|NCT00443456|O2|Outcome|Subjects Without Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who did not use concomitant antihypertensive agent during this long-term study (A0531086: NCT00443456).
1146686|NCT00443456|O1|Outcome|Subjects With Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who were treated with concomitant antihypertensive agent at Week 12 or later.
1149034|NCT00438451|E3|Reported Event|Lamotrigine|Lamotrigine 25mg
1146687|NCT00443456|O3|Outcome|The Preceding Study 10 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
1146688|NCT00443456|O2|Outcome|The Preceding Study 5 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
1146689|NCT00443456|O1|Outcome|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
1146690|NCT00443456|O3|Outcome|The Preceding Study 10 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
1146691|NCT00443456|O2|Outcome|The Preceding Study 5 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
1146692|NCT00443456|O1|Outcome|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
1146693|NCT00443456|O2|Outcome|Subjects Without Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who did not use concomitant antihypertensive agent during this long-term study (A0531086: NCT00443456).
1146694|NCT00443456|O1|Outcome|Subjects With Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who were treated with concomitant antihypertensive agent at Week 12 or later.
1146695|NCT00443456|O2|Outcome|Subjects Without Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who did not use concomitant antihypertensive agent during this long-term study (A0531086: NCT00443456).
1146696|NCT00443456|O1|Outcome|Subjects With Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who were treated with concomitant antihypertensive agent at Week 12 or later.
1146697|NCT00443456|O2|Outcome|Subjects Without Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who did not use concomitant antihypertensive agent during this long-term study (A0531086: NCT00443456).
1146698|NCT00443456|O1|Outcome|Subjects With Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who were treated with concomitant antihypertensive agent at Week 12 or later.
1146699|NCT00443456|O2|Outcome|Subjects Without Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who did not use concomitant antihypertensive agent during this long-term study (A0531086: NCT00443456).
1146700|NCT00443456|O1|Outcome|Subjects With Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who were treated with concomitant antihypertensive agent at Week 12 or later.
1146701|NCT00443456|O3|Outcome|The Preceding Study 10 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
1146702|NCT00443456|O2|Outcome|The Preceding Study 5 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
1146703|NCT00443456|O1|Outcome|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
1146704|NCT00443456|O3|Outcome|The Preceding Study 10 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
1146706|NCT00443456|O1|Outcome|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
1146707|NCT00443456|O3|Outcome|The Preceding Study 10 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
1146708|NCT00443456|O2|Outcome|The Preceding Study 5 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
1146709|NCT00443456|O1|Outcome|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
1146710|NCT00443456|O3|Outcome|The Preceding Study 10 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
1146711|NCT00443456|O2|Outcome|The Preceding Study 5 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
1146712|NCT00443456|O1|Outcome|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
1146713|NCT00443456|E1|Reported Event|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study
1146714|NCT00443430|B3|Baseline|Total|Total of all reporting groups
1146715|NCT00443430|B2|Baseline|Methotrexate-Prednisolone-Etanercept Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks
1146716|NCT00443430|B1|Baseline|Methotrexate Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
1146717|NCT00443430|P2|Participant Flow|Methotrexate-Prednisolone-Etanercept Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks
1146718|NCT00443430|P1|Participant Flow|Methotrexate Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
1146719|NCT00443430|O2|Outcome|Methotrexate-Prednisolone-Etanercept Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks
1146720|NCT00443430|O1|Outcome|Methotrexate Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
1146721|NCT00443430|O2|Outcome|Methotrexate-Prednisolone-Etanercept Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks
1146722|NCT00443430|O1|Outcome|Methotrexate Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
1146723|NCT00443430|O2|Outcome|Methotrexate-Prednisolone-Etanercept Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks
1146724|NCT00443430|O1|Outcome|Methotrexate Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
1146725|NCT00443430|E2|Reported Event|Methotrexate-Prednisolone-Etanercept Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks
1146726|NCT00443430|E1|Reported Event|Methotrexate Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
1146727|NCT00443352|B1|Baseline|Duloxetine Completers|duloxetine: Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
1146728|NCT00443352|P1|Participant Flow|Duloxetine|Duloxetine: Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
1146729|NCT00443352|O1|Outcome|Duloxetine|duloxetine: Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
1146730|NCT00443352|E1|Reported Event|Duloxetine|duloxetine: Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
1146731|NCT00443261|B1|Baseline|1: SCCHN|"Azacitidine and cisplatin~Azacitidine: SC azacitidine~Cisplatin: cisplatin 75 mg/m2 day 8 every 28 days"
1146732|NCT00443261|P1|Participant Flow|Arm 1: SCCHN|"Intervention:~Azacitidine: SC daily X 5 every 28 days azacitidine at assigned dose ranging from 37 to 110 mg/M^2/day.~Cisplatin: cisplatin 75 mg/m^2 day 8 every 28 days"
1146733|NCT00443261|O1|Outcome|Arm 1: SCCHN|"Azacitidine and cisplatin~Azacitidine: SC azacitidine~Cisplatin: cisplatin 75 mg/m^2 day 8 every 28 days"
1146734|NCT00443261|E1|Reported Event|1: SCCHN|"Azacitidine and cisplatin~Azacitidine: SC azacitidine~Cisplatin: cisplatin 75 mg/m2 day 8 every 28 days"
1146735|NCT00443209|B3|Baseline|Total|Total of all reporting groups
1146736|NCT00443209|B2|Baseline|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
1146737|NCT00443209|B1|Baseline|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
1146738|NCT00443209|P2|Participant Flow|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
1146763|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Without PEEP valve
1146739|NCT00443209|P1|Participant Flow|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
1146740|NCT00443209|O2|Outcome|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
1146741|NCT00443209|O1|Outcome|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
1146742|NCT00443209|O2|Outcome|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
1146743|NCT00443209|O1|Outcome|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
1146744|NCT00443209|O2|Outcome|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
1146795|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Subjects allocated to SIB-Without PEEP valve attached
1146796|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to SIB with PEEP valve attached
1146797|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
1146745|NCT00443209|O1|Outcome|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
1146746|NCT00443209|O2|Outcome|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
1146747|NCT00443209|O1|Outcome|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
1146748|NCT00443209|O2|Outcome|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
1146749|NCT00443209|O1|Outcome|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
1146750|NCT00443209|E2|Reported Event|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
1146751|NCT00443209|E1|Reported Event|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
1146752|NCT00443118|B4|Baseline|Total|Total of all reporting groups
1146753|NCT00443118|B3|Baseline|Self Inflating Bag Without PEEP|Subjects allocated to Self Inflating Bag without PEEP
1146754|NCT00443118|B2|Baseline|Self Inflating Bag With PEEP|Subjects allocated to Self Inflating Bag with PEEP
1146755|NCT00443118|B1|Baseline|T-Piece|Subjects assigned to be resuscitated with T-Piece
1146756|NCT00443118|P3|Participant Flow|SIB-Without PEEP Valve|Self inflating bag without PEEP valve
1146757|NCT00443118|P2|Participant Flow|SIB - With PEEP Valve|Subjects allocated to SIB with a PEEP valve attached
1146758|NCT00443118|P1|Participant Flow|T-Piece|Subjects assigned to be resuscitated with T-Piece
1146759|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Subjects allocated to be resuscitated with Self Inflating Bag Without PEEP valve
1146760|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with PEEP valve
1146761|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
1146762|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Subjects allocated to SIB-Without PEEP valve
1156702|NCT00420017|P1|Participant Flow|Amiodarone|Intravenous amiodarone
1146772|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with PEEP valve
1146773|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
1146774|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Subjects allocated to SIB-Without PEEP valve
1146775|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with PEEP valve
1146776|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
1146777|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Self Inflating Bag without PEEP valve
1146778|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with PEEP valve
1146779|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
1146780|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Subjects allocated to Self Inflating Bag Without PEEP valve
1146781|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with PEEP valve
1146782|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
1146783|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Subjects Allocated to SIB without PEEP valve
1146784|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to SIB with PEEP valve
1146785|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
1146786|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Subjects allocated to Self Inflating Bag without PEEP valve
1146787|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with a PEEP valve attached
1146788|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
1146789|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Sujects allocated to be ventilated with Self Inflating Bag Without PEEP valve
1146790|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to be ventilated using a Self Inlfating Bag with PEEP valve
1146791|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
1146792|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Subjects allocated to Self Inflating Bag withouth a PEEP valve
1146793|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with PEEP valve
1146799|NCT00443118|E2|Reported Event|SIB - Self Inflating Bag With PEEP|Subjects allocated to be ventilated with Self Inflating Bag with PEEP valve
1146800|NCT00443118|E1|Reported Event|T-Piece|Subjects assigned to be resuscitated with T-Piece
1146801|NCT00443053|B3|Baseline|Total|Total of all reporting groups
1146802|NCT00443053|B2|Baseline|Placebo|Matching placebo
1146803|NCT00443053|B1|Baseline|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
1146804|NCT00443053|P2|Participant Flow|Placebo|Matching placebo
1146805|NCT00443053|P1|Participant Flow|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
1146806|NCT00443053|O2|Outcome|Placebo|Matching placebo
1146807|NCT00443053|O1|Outcome|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
1146808|NCT00443053|O2|Outcome|Placebo|Matching placebo
1146809|NCT00443053|O1|Outcome|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
1146810|NCT00443053|O2|Outcome|Placebo|Matching placebo
1146811|NCT00443053|O1|Outcome|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
1146812|NCT00443053|O2|Outcome|Placebo|Matching placebo
1146813|NCT00443053|O1|Outcome|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
1146814|NCT00443053|O2|Outcome|Placebo|Matching placebo
1146815|NCT00443053|O1|Outcome|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
1146816|NCT00443053|O2|Outcome|Placebo|Matching placebo
1146817|NCT00443053|O1|Outcome|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
1146818|NCT00443053|O2|Outcome|Placebo|Matching placebo
1146819|NCT00443053|O1|Outcome|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
1146820|NCT00443053|E2|Reported Event|Placebo|Matching placebo
1146821|NCT00443053|E1|Reported Event|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
1146822|NCT00443040|B4|Baseline|Total|Total of all reporting groups
1146823|NCT00443040|B3|Baseline|Placebo|Matching Placebo
1146824|NCT00443040|B2|Baseline|Asimadoline 3.0 mg|Asimadoline 3.0 mg b.i.d.
1146825|NCT00443040|B1|Baseline|Asimadoline 1.0 mg|Asimadoline 1.0 mg b.i.d.
1146826|NCT00443040|P3|Participant Flow|Placebo|Matching Placebo
1146827|NCT00443040|P2|Participant Flow|Asimadoline 3.0 mg|Asimadoline 3.0 mg b.i.d.
1146828|NCT00443040|P1|Participant Flow|Asimadoline 1.0 mg|Asimadoline 1.0 mg b.i.d.
1146829|NCT00443040|O3|Outcome|Placebo|Matching Placebo
1146830|NCT00443040|O2|Outcome|Asimadoline 3.0 mg|Asimadoline 3.0 mg b.i.d.
1146831|NCT00443040|O1|Outcome|Asimadoline 1.0 mg|Asimadoline 1.0 mg b.i.d.
1146832|NCT00443040|E3|Reported Event|Placebo|Matching Placebo
1146833|NCT00443040|E2|Reported Event|Asimadoline 3.0 mg|Asimadoline 3.0 mg b.i.d.
1146834|NCT00443040|E1|Reported Event|Asimadoline 1.0 mg|Asimadoline 1.0 mg b.i.d.
1146835|NCT00442962|B1|Baseline|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
1146836|NCT00442962|P1|Participant Flow|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
1146837|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
1146838|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
1146839|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
1146840|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
1146841|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
1146842|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
1146843|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
1146844|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
1146845|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
1146846|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
1146847|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
1146848|NCT00442962|E1|Reported Event|EFV+FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
1146849|NCT00442936|B5|Baseline|Total|Total of all reporting groups
1146850|NCT00442936|B4|Baseline|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
1146851|NCT00442936|B3|Baseline|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
1146966|NCT00442611|O2|Outcome|IV Fluid|"The placebo arm will receive matched intravenous fluids.~Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
1146852|NCT00442936|B2|Baseline|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
1146853|NCT00442936|B1|Baseline|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
1146854|NCT00442936|P4|Participant Flow|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
1146855|NCT00442936|P3|Participant Flow|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
1146856|NCT00442936|P2|Participant Flow|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
1146857|NCT00442936|P1|Participant Flow|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
1146858|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
1146859|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
1146860|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
1146861|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
1156703|NCT00420017|O2|Outcome|Control|Control usual care
1146862|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
1146863|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
1146864|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
1146865|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
1146866|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
1146867|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
1146868|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
1147247|NCT00442364|B1|Baseline|Safety Evaluable|patients treated with polidocanol 1% injectable foam with circulating bubbles present on MRI
1149035|NCT00438451|E2|Reported Event|Carbamazepine|Carbamazepine 100mg
1146869|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
1146870|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
1146871|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
1146872|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
1146873|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
1146874|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
1146875|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
1146876|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
1146877|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
1146878|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
1146952|NCT00442689|O1|Outcome|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
1146953|NCT00442689|O3|Outcome|Placebo - 3|Placebo
1146954|NCT00442689|O2|Outcome|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
1146879|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
1146880|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
1146881|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
1146882|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
1146883|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
1146884|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
1146885|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
1146886|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
1146887|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
1146888|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
1146889|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
1146890|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
1146891|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
1146892|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
1146893|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
1146894|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
1146895|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
1146955|NCT00442689|O1|Outcome|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
1146956|NCT00442689|E3|Reported Event|Placebo - 3|Placebo only
1146957|NCT00442689|E2|Reported Event|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
1146896|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
1146897|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
1146898|NCT00442936|E4|Reported Event|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
1146899|NCT00442936|E3|Reported Event|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
1146900|NCT00442936|E2|Reported Event|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
1146901|NCT00442936|E1|Reported Event|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
1146902|NCT00442897|B3|Baseline|Total|Total of all reporting groups
1146903|NCT00442897|B2|Baseline|Atorvastatin|Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.
1147248|NCT00442364|P1|Participant Flow|Polidocanol 1% Injectable Microfoam|polidocanol injectable microfoam 1%
1146904|NCT00442897|B1|Baseline|Vytorin|Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C < 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.
1146905|NCT00442897|P2|Participant Flow|Atorvastatin|Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.
1146906|NCT00442897|P1|Participant Flow|Vytorin|Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C < 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.
1146907|NCT00442897|O2|Outcome|Atorvastatin|Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.
1146908|NCT00442897|O1|Outcome|Vytorin|Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C < 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.
1146909|NCT00442897|O2|Outcome|Atorvastatin|Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.
1146910|NCT00442897|O1|Outcome|Vytorin|Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C < 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.
1146911|NCT00442897|E2|Reported Event|Atorvastatin|Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.
1146912|NCT00442897|E1|Reported Event|Vytorin|Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C < 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.
1146913|NCT00442702|B3|Baseline|Total|Total of all reporting groups
1146914|NCT00442702|B2|Baseline|Darbepoetin Alfa|Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
1146915|NCT00442702|B1|Baseline|Mircera|Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
1146916|NCT00442702|P2|Participant Flow|Darbepoetin Alfa|Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
1146917|NCT00442702|P1|Participant Flow|Mircera|Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
1146918|NCT00442702|O2|Outcome|Darbepoetin Alfa|Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
1146919|NCT00442702|O1|Outcome|Mircera|Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
1146920|NCT00442702|O2|Outcome|Darbepoetin Alfa|Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
1146921|NCT00442702|O1|Outcome|Mircera|Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
1146922|NCT00442702|O2|Outcome|Darbepoetin Alfa|Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
1147053|NCT00442546|P3|Participant Flow|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1146923|NCT00442702|O1|Outcome|Mircera|Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
1146924|NCT00442702|O2|Outcome|Darbepoetin Alfa|Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
1146925|NCT00442702|O1|Outcome|Mircera|Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
1146926|NCT00442702|E2|Reported Event|Darbepoetin Alfa|Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
1146927|NCT00442702|E1|Reported Event|Mircera|Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
1146928|NCT00442689|B4|Baseline|Total|Total of all reporting groups
1146929|NCT00442689|B3|Baseline|Placebo - 3|Placebo
1146930|NCT00442689|B2|Baseline|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
1146931|NCT00442689|B1|Baseline|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
1146932|NCT00442689|P3|Participant Flow|Placebo - 3|Placebo only
1146933|NCT00442689|P2|Participant Flow|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
1146934|NCT00442689|P1|Participant Flow|Oral Contraceptive - 1|"Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)~Oral contraceptive: one active pill per day for three weeks and then 1 sugar pill per day for one week"
1146935|NCT00442689|O3|Outcome|Placebo - 3|Placebo
1146936|NCT00442689|O2|Outcome|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
1146937|NCT00442689|O1|Outcome|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
1146938|NCT00442689|O3|Outcome|Placebo - 3|Placebo
1146939|NCT00442689|O2|Outcome|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
1146940|NCT00442689|O1|Outcome|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
1146941|NCT00442689|O3|Outcome|Placebo - 3|Placebo
1146942|NCT00442689|O2|Outcome|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
1146943|NCT00442689|O1|Outcome|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
1146944|NCT00442689|O3|Outcome|Placebo - 3|Placebo
1146945|NCT00442689|O2|Outcome|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
1146946|NCT00442689|O1|Outcome|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
1146947|NCT00442689|O3|Outcome|Placebo - 3|Placebo
1146948|NCT00442689|O2|Outcome|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
1146949|NCT00442689|O1|Outcome|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
1146950|NCT00442689|O3|Outcome|Placebo - 3|Placebo
1146951|NCT00442689|O2|Outcome|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
1146958|NCT00442689|E1|Reported Event|Oral Contraceptive - 1|"Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)~Oral contraceptive: one active pill per day for three weeks and then 1 sugar pill per day for one week"
1146959|NCT00442611|B3|Baseline|Total|Total of all reporting groups
1146960|NCT00442611|B2|Baseline|IV Fluid|"The placebo arm will receive matched intravenous fluids.~Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
1146961|NCT00442611|B1|Baseline|Abatacept|"Study drug, Abatacept, will be administered in a double-blind fashion to the active arm of the study. It will be administered intravenously.~Abatacept: Active drug, abatacept, will be administered intravenously in a blinded fashion~Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
1146962|NCT00442611|P2|Participant Flow|IV Fluid|"The placebo arm will receive matched intravenous fluids.~Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
1146963|NCT00442611|P1|Participant Flow|Abatacept|"Study drug, Abatacept, will be administered in a double-blind fashion to the active arm of the study. It will be administered intravenously.~Abatacept: Active drug, abatacept, will be administered intravenously in a blinded fashion~Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
1146964|NCT00442611|O2|Outcome|IV Fluid|"The placebo arm will receive matched intravenous fluids.~Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
1146965|NCT00442611|O1|Outcome|Abatacept|"Study drug, Abatacept, will be administered in a double-blind fashion to the active arm of the study. It will be administered intravenously.~Abatacept: Active drug, abatacept, will be administered intravenously in a blinded fashion~Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
1147249|NCT00442364|O1|Outcome|Safety Evaluable Population|polidocanol injectable foam 1% with circulating MCA bubbles present at MRI
1146967|NCT00442611|O1|Outcome|Abatacept|"Study drug, Abatacept, will be administered in a double-blind fashion to the active arm of the study. It will be administered intravenously.~Abatacept: Active drug, abatacept, will be administered intravenously in a blinded fashion~Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
1146968|NCT00442611|O2|Outcome|IV Fluid|"The placebo arm will receive matched intravenous fluids.~Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
1146969|NCT00442611|O1|Outcome|Abatacept|"Study drug, Abatacept, will be administered in a double-blind fashion to the active arm of the study. It will be administered intravenously.~Abatacept: Active drug, abatacept, will be administered intravenously in a blinded fashion~Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
1146970|NCT00442611|E2|Reported Event|IV Fluid|"The placebo arm will receive matched intravenous fluids.~Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
1146971|NCT00442611|E1|Reported Event|Abatacept|"Study drug, Abatacept, will be administered in a double-blind fashion to the active arm of the study. It will be administered intravenously.~Abatacept: Active drug, abatacept, will be administered intravenously in a blinded fashion~Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
1146972|NCT00442598|B4|Baseline|Total|Total of all reporting groups
1146973|NCT00442598|B3|Baseline|Glufosfamide q7 Days High|"1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
1146974|NCT00442598|B2|Baseline|Glufosfamide q7 Days Low|"1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
1146975|NCT00442598|B1|Baseline|Glufosfamide q21 Days|"1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle~Glufosfamide"
1146976|NCT00442598|P3|Participant Flow|Glufosfamide q7 Days High|"1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
1146977|NCT00442598|P2|Participant Flow|Glufosfamide q7 Days Low|"1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
1146978|NCT00442598|P1|Participant Flow|Glufosfamide q21 Days|"1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle~Glufosfamide"
1146979|NCT00442598|O3|Outcome|Glufosfamide q7 Days High|"1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
1146980|NCT00442598|O2|Outcome|Glufosfamide q7 Days Low|"1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
1146981|NCT00442598|O1|Outcome|Glufosfamide q21 Days|"1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle~Glufosfamide"
1146982|NCT00442598|O3|Outcome|Glufosfamide q7 Days High|"1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
1146983|NCT00442598|O2|Outcome|Glufosfamide q7 Days Low|"1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
1146984|NCT00442598|O1|Outcome|Glufosfamide q21 Days|"1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle~Glufosfamide"
1146985|NCT00442598|O3|Outcome|Glufosfamide q7 Days High|"1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
1146986|NCT00442598|O2|Outcome|Glufosfamide q7 Days Low|"1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
1146987|NCT00442598|O1|Outcome|Glufosfamide q21 Days|"1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle~Glufosfamide"
1146988|NCT00442598|O3|Outcome|Glufosfamide q7 Days High|"1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
1146989|NCT00442598|O2|Outcome|Glufosfamide q7 Days Low|"1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
1146990|NCT00442598|O1|Outcome|Glufosfamide q21 Days|"1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle~Glufosfamide"
1146991|NCT00442598|E2|Reported Event|Glufosfamide q7 Days Low|"1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
1146992|NCT00442598|E1|Reported Event|Glufosfamide q21 Days|"1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle~Glufosfamide"
1146993|NCT00442572|B3|Baseline|Total|Total of all reporting groups
1146994|NCT00442572|B2|Baseline|No Intervention|Participants were on non- specific anti-viral treatment.
1146995|NCT00442572|B1|Baseline|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
1146996|NCT00442572|P2|Participant Flow|No Intervention|Participants were on non- specific anti-viral treatment.
1146997|NCT00442572|P1|Participant Flow|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a (PEGASYS®). Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 micrograms (µg) in 0.5 ml solution in prefilled syringes, applied once weekly subcutaneously (SC) and followed by 12 weeks period without treatment.
1146998|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
1146999|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
1147000|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
1147001|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
1147002|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
1147003|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
1147004|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
1147005|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
1147006|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
1147007|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
1147008|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
1147009|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
1147010|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
1147011|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
1147012|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
1147013|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
1147014|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
1147015|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
1147016|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
1147017|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
1147018|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
1147019|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
1147020|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
1147021|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
1147022|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
1148122|NCT00440531|P3|Participant Flow|ENGERIX-B™|ENGERIX-B™, 20 µg (micrograms)
1147023|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
1147024|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
1147025|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
1147026|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
1147027|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
1147028|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
1147029|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
1147030|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
1147031|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment..
1147032|NCT00442572|E2|Reported Event|No Intervention|Participants were on non- specific anti-viral treatment.
1147054|NCT00442546|P2|Participant Flow|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147033|NCT00442572|E1|Reported Event|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 micrograms in 0.5 ml solution in prefilled syringes, applied once weekly subcutaneously and followed by 12 weeks period without treatment.
1147034|NCT00442559|B3|Baseline|Total|Total of all reporting groups
1147035|NCT00442559|B2|Baseline|Inhaled Corticosteroids (ICS)|Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
1147036|NCT00442559|B1|Baseline|Montelukast|Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
1147037|NCT00442559|P2|Participant Flow|Inhaled Corticosteroids (ICS)|Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
1147038|NCT00442559|P1|Participant Flow|Montelukast|Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
1147039|NCT00442559|O4|Outcome|Daily Allergic Rhinitis Symptom Score 12 Weeks - ICS|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
1147040|NCT00442559|O3|Outcome|Daily Allergic Rhinitis Symptom Score at Baseline - ICS|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
1147041|NCT00442559|O2|Outcome|Daily Allergic Rhinitis Symptom Score at 12 Weeks- Montelukast|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
1147042|NCT00442559|O1|Outcome|Daily Allergic Rhinitis Symptom Score at Baseline- Montelukast|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
1147043|NCT00442559|O4|Outcome|Daytime Asthma Symptom Score at 12 Weeks - ICS|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
1147044|NCT00442559|O3|Outcome|Daytime Asthma Symptom Score at Baseline - ICS|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
1147045|NCT00442559|O2|Outcome|Daytime Asthma Symptom Score at 12 Weeks - Montelukast|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
1147046|NCT00442559|O1|Outcome|Daytime Asthma Symptom Score at Baseline - Montelukast|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
1147047|NCT00442559|E2|Reported Event|Inhaled Corticosteroids (ICS)|Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
1147048|NCT00442559|E1|Reported Event|Montelukast|Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
1147049|NCT00442546|B4|Baseline|Total|Total of all reporting groups
1147050|NCT00442546|B3|Baseline|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147051|NCT00442546|B2|Baseline|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147052|NCT00442546|B1|Baseline|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1149036|NCT00438451|E1|Reported Event|Levetiracetam|Levetiracetam 250mg
1147055|NCT00442546|P1|Participant Flow|Pregabalin (150 Milligrams [mg])|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on Post-Operative Day 1 (POD 1).
1147056|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147057|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147058|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147059|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147060|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147061|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147062|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147063|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147064|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147065|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147066|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147067|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147068|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147069|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1148123|NCT00440531|P2|Participant Flow|RECOMBIVAX-HB™|RECOMBIVAX-HB™, 10 µg (micrograms)
1147070|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147071|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147072|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147073|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147074|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147075|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147076|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147077|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147078|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147250|NCT00442364|E1|Reported Event|Safety Evaluable|patients treated with polidocanol 1% injectable foam with circulating bubbles present on MRI
1147079|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147080|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147081|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147082|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147083|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147084|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147085|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147086|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147087|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147088|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147089|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147090|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147091|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147092|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147093|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147094|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147095|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147096|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147097|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147098|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147099|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147100|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147101|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147102|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147103|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147104|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147105|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147106|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147107|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147108|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147109|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147110|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147111|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147112|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147113|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147114|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147115|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147116|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147117|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147118|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147119|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147120|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147121|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147122|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147123|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147124|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147125|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147126|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147127|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147128|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147129|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147130|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147131|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147132|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147133|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147134|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147135|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147136|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147137|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147138|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147139|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147140|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147141|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147142|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147143|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147144|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147145|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147146|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147147|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147148|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147149|NCT00442546|O2|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147150|NCT00442546|O1|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147151|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147152|NCT00442546|O1|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147153|NCT00442546|O2|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147154|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147155|NCT00442546|O1|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147156|NCT00442546|O2|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147157|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147158|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147159|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147160|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147161|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147162|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147163|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147164|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147165|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147166|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147167|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147168|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147169|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147170|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147171|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147172|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147173|NCT00442546|E3|Reported Event|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
1147174|NCT00442546|E2|Reported Event|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147175|NCT00442546|E1|Reported Event|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
1147176|NCT00442507|B1|Baseline|Erlotinib and Avastin|Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
1147201|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
1147251|NCT00442351|B3|Baseline|Total|Total of all reporting groups
1147601|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
1147177|NCT00442507|P1|Participant Flow|Erlotinib and Avastin|Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
1147178|NCT00442507|O1|Outcome|Erlotinib and Avastin|Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
1147179|NCT00442507|O1|Outcome|Erlotinib and Avastin|Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
1147180|NCT00442507|O1|Outcome|Erlotinib and Avastin|Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
1147181|NCT00442507|O1|Outcome|Erlotinib and Avastin|Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
1147182|NCT00442507|E1|Reported Event|Erlotinib and Avastin|Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
1147183|NCT00442468|B1|Baseline|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
1147184|NCT00442468|P1|Participant Flow|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
1147185|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
1147186|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
1147187|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
1147188|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
1147189|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
1147190|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
1147191|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
1147312|NCT00442169|O1|Outcome|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
1147192|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
1147193|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
1147194|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
1147195|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
1147196|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
1147197|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
1147198|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
1147199|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
1147200|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
1147602|NCT00441480|O2|Outcome|Control|Corn oil
1147202|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
1147203|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
1147204|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
1147205|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
1147206|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
1147207|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
1147208|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
1147209|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
1147210|NCT00442468|E1|Reported Event|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
1147211|NCT00442416|B3|Baseline|Total|Total of all reporting groups
1147212|NCT00442416|B2|Baseline|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
1147213|NCT00442416|B1|Baseline|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
1147214|NCT00442416|P2|Participant Flow|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
1147215|NCT00442416|P1|Participant Flow|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
1147216|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
1147430|NCT00441727|P2|Participant Flow|Esomeproazole 20|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
1147217|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
1147218|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
1147219|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
1147233|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
1147252|NCT00442351|B2|Baseline|Placebo Inhaler|Placebo for Asmanex Twisthaler 220 mcg, provided once daily in the evening for 12 weeks
1147253|NCT00442351|B1|Baseline|Asmanex Twisthaler|Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
1147220|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
1147221|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
1147222|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
1147223|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
1147224|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
1147225|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
1147226|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
1147227|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
1147228|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
1147229|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
1147310|NCT00442169|O3|Outcome|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
1147230|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
1147231|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
1147232|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
1147234|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
1147235|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
1147236|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
1147237|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
1147238|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
1147239|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
1147240|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
1147241|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
1147242|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
1147311|NCT00442169|O2|Outcome|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
1147243|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
1147244|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
1147245|NCT00442416|E2|Reported Event|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
1147246|NCT00442416|E1|Reported Event|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
1147254|NCT00442351|P2|Participant Flow|Placebo Inhaler|Placebo for Asmanex Twisthaler 220 mcg, provided once daily in the evening for 12 weeks
1147255|NCT00442351|P1|Participant Flow|Asmanex Twisthaler|Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
1147256|NCT00442351|O2|Outcome|Placebo Inhaler|Placebo for Asmanex Twisthaler 220 mcg, provided once daily in the evening for 12 weeks
1147257|NCT00442351|O1|Outcome|Asmanex Twisthaler|Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
1147258|NCT00442351|E2|Reported Event|Placebo Inhaler|Placebo for Asmanex Twisthaler 220 mcg, provided once daily in the evening for 12 weeks
1147259|NCT00442351|E1|Reported Event|Asmanex Twisthaler|Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
1147260|NCT00442338|B4|Baseline|Total|Total of all reporting groups
1147261|NCT00442338|B3|Baseline|Aminophylline 250 mg|Aminophylline 250 mg IV drip administration
1147262|NCT00442338|B2|Baseline|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
1147263|NCT00442338|B1|Baseline|Montelukast 7 mg|Montelukast 7 mg IV Administration
1147264|NCT00442338|P3|Participant Flow|Aminophylline 250 mg|Aminophylline 250 mg IV drip administration
1147265|NCT00442338|P2|Participant Flow|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
1147266|NCT00442338|P1|Participant Flow|Montelukast 7 mg|Montelukast 7 mg IV Administration
1147267|NCT00442338|O3|Outcome|Aminophylline 250 mg|Aminophylline 250 mg IV drip administration
1147268|NCT00442338|O2|Outcome|Montelukast 14 mg|Montelukast 14 mg IV Administration
1147269|NCT00442338|O1|Outcome|Montelukast 7 mg|Montelukast 7 mg IV Administration
1147270|NCT00442338|E3|Reported Event|Aminophylline 250 mg|Aminophylline 250 mg IV drip administration
1147271|NCT00442338|E2|Reported Event|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
1147272|NCT00442338|E1|Reported Event|Montelukast 7 mg|Montelukast 7 mg IV Administration
1147273|NCT00442286|B4|Baseline|Total|Total of all reporting groups
1147274|NCT00442286|B3|Baseline|Rheos® Device Off|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.~Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
1147275|NCT00442286|B2|Baseline|Rheos® Device On|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.~Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
1147276|NCT00442286|B1|Baseline|Roll-In|Subjects that were not included in endpoint analyses
1147277|NCT00442286|P2|Participant Flow|Rheos® Device Off|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.~Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
1147278|NCT00442286|P1|Participant Flow|Rheos® Device On|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.~Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
1147279|NCT00442286|O2|Outcome|Rheos® Device Off|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.~Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
1147280|NCT00442286|O1|Outcome|Rheos® Device On|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.~Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
1147281|NCT00442286|O1|Outcome|All Implanted or Attempted Patients|All Implanted or Attempted patients active at 30 days post-implant. Excludes roll-in patients.
1147282|NCT00442286|O1|Outcome|All Implanted or Attempted Patients|All Implanted or Attempted patients enrolled in the study. Roll-ins were excluded.
1147283|NCT00442286|O1|Outcome|Rheos® Device On|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.~Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
1147284|NCT00442286|O2|Outcome|Rheos® Device Off|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.~Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
1147285|NCT00442286|O1|Outcome|Rheos® Device On|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.~Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
1147286|NCT00442286|E2|Reported Event|Rheos® Device Off|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.~Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
1147377|NCT00441974|O2|Outcome|HBeAg- at Baseline|Participants who had undetectable HBeAg as measured by a local laboratory
1147287|NCT00442286|E1|Reported Event|Rheos® Device On|"Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.~Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex"
1147288|NCT00442169|B7|Baseline|Total|Total of all reporting groups
1147289|NCT00442169|B6|Baseline|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
1147290|NCT00442169|B5|Baseline|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
1147291|NCT00442169|B4|Baseline|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
1147292|NCT00442169|B3|Baseline|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
1147293|NCT00442169|B2|Baseline|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
1147294|NCT00442169|B1|Baseline|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
1147295|NCT00442169|P6|Participant Flow|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
1147296|NCT00442169|P5|Participant Flow|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
1147297|NCT00442169|P4|Participant Flow|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
1147298|NCT00442169|P3|Participant Flow|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
1147299|NCT00442169|P2|Participant Flow|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
1147300|NCT00442169|P1|Participant Flow|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
1147301|NCT00442169|O6|Outcome|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
1147302|NCT00442169|O5|Outcome|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
1147303|NCT00442169|O4|Outcome|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
1147304|NCT00442169|O3|Outcome|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
1147305|NCT00442169|O2|Outcome|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
1147306|NCT00442169|O1|Outcome|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
1147307|NCT00442169|O6|Outcome|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
1147308|NCT00442169|O5|Outcome|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
1147309|NCT00442169|O4|Outcome|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
1156704|NCT00420017|O1|Outcome|Amiodarone|Intravenous amiodarone
1147313|NCT00442169|O6|Outcome|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
1147314|NCT00442169|O5|Outcome|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
1147315|NCT00442169|O4|Outcome|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
1147316|NCT00442169|O3|Outcome|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
1147317|NCT00442169|O2|Outcome|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
1147318|NCT00442169|O1|Outcome|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
1147319|NCT00442169|O6|Outcome|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
1147320|NCT00442169|O5|Outcome|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
1147321|NCT00442169|O4|Outcome|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
1147322|NCT00442169|O3|Outcome|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
1147323|NCT00442169|O2|Outcome|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
1147324|NCT00442169|O1|Outcome|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
1147325|NCT00442169|O6|Outcome|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
1147326|NCT00442169|O5|Outcome|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
1147327|NCT00442169|O4|Outcome|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
1147328|NCT00442169|O3|Outcome|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
1147677|NCT00441363|B3|Baseline|Total|Total of all reporting groups
1147329|NCT00442169|O2|Outcome|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
1147330|NCT00442169|O1|Outcome|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
1147331|NCT00442169|E6|Reported Event|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
1147332|NCT00442169|E5|Reported Event|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
1147333|NCT00442169|E4|Reported Event|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
1147334|NCT00442169|E3|Reported Event|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
1147335|NCT00442169|E2|Reported Event|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
1147336|NCT00442169|E1|Reported Event|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
1147337|NCT00442117|B3|Baseline|Total|Total of all reporting groups
1147338|NCT00442117|B2|Baseline|BUD-DPI|Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
1147339|NCT00442117|B1|Baseline|MF-DPI|Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
1147340|NCT00442117|P2|Participant Flow|BUD-DPI|Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
1147341|NCT00442117|P1|Participant Flow|MF-DPI|Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
1147342|NCT00442117|O2|Outcome|BUD-DPI|Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
1147343|NCT00442117|O1|Outcome|MF-DPI|Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
1147344|NCT00442117|O2|Outcome|BUD-DPI|Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
1147345|NCT00442117|O1|Outcome|MF-DPI|Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
1147346|NCT00442117|O2|Outcome|BUD-DPI|Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
1147347|NCT00442117|O1|Outcome|MF-DPI|Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
1147348|NCT00442117|O2|Outcome|BUD-DPI|Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
1147349|NCT00442117|O1|Outcome|MF-DPI|Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
1147350|NCT00442117|E2|Reported Event|BUD-DPI|Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
1147351|NCT00442117|E1|Reported Event|MF-DPI|Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
1147352|NCT00442013|B3|Baseline|Total|Total of all reporting groups
1147353|NCT00442013|B2|Baseline|Placebo Group|Matching placebo
1147354|NCT00442013|B1|Baseline|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
1147355|NCT00442013|P2|Participant Flow|Placebo Group|Matching placebo with no active ingredients. Either 1 or 2 tablets per day, depending on weight, in the evening before a meal
1147431|NCT00441727|P1|Participant Flow|Esomeprazole 40|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
1147356|NCT00442013|P1|Participant Flow|Lansoprazole Group|15 mg/day by mouth for children weighing less than 30kg, one tablet per day in the evening before a meal 30 mg/day by mouth for children weighing 30 kg or more, two tablets per day in the evening before a meal
1147357|NCT00442013|O2|Outcome|Placebo Group|matching placebo
1147358|NCT00442013|O1|Outcome|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
1147359|NCT00442013|O2|Outcome|Placebo Group|Matching placebo
1147360|NCT00442013|O1|Outcome|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
1147361|NCT00442013|O2|Outcome|Placebo Group|Matching placebo
1147362|NCT00442013|O1|Outcome|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
1147363|NCT00442013|O2|Outcome|Placebo Group|Matching placebo
1147364|NCT00442013|O1|Outcome|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
1147365|NCT00442013|O2|Outcome|Placebo Group|Matching placebo
1147366|NCT00442013|O1|Outcome|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
1147367|NCT00442013|O2|Outcome|Placebo Group|matching placebo
1147368|NCT00442013|O1|Outcome|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
1147369|NCT00442013|E2|Reported Event|Placebo Group|Matching placebo
1147370|NCT00442013|E1|Reported Event|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
1147371|NCT00441974|B1|Baseline|10 mg Adefovir Dipivoxil|Adefovir Dipivoxil (ADV) 10 mg tablets once daily for 48 weeks
1147372|NCT00441974|P1|Participant Flow|10 mg Adefovir Dipivoxil|Adefovir Dipivoxil (ADV) 10 mg tablets once daily for 48 weeks
1147373|NCT00441974|O1|Outcome|10 mg Adefovir Dipivoxil|Adefovir Dipivoxil (ADV) 10 mg tablets once daily for 48 weeks
1147374|NCT00441974|O1|Outcome|HBeAg+ at Baseline|Participants who had detectable HBeAg (Hepatitis B e Antigens) as measured by a local laboratory
1147375|NCT00441974|O2|Outcome|HBeAg- at Baseline|Participants who had undetectable HBeAg as measured by a local laboratory
1147376|NCT00441974|O1|Outcome|HBeAg+ at Baseline|Participants who had detectable HBeAg (Hepatitis B e Antigens) as measured by a local laboratory
1147678|NCT00441363|B2|Baseline|Placebo|matching placebo
1147378|NCT00441974|O1|Outcome|HBeAg+ at Baseline|Participants who had detectable HBeAg (Hepatitis B e Antigens) as measured by a local laboratory
1147379|NCT00441974|O1|Outcome|HBeAg+ at Baseline|Participants who had detectable HBeAg (Hepatitis B e Antigens) as measured by a local laboratory
1147380|NCT00441974|O1|Outcome|HBeAg+ at Baseline|Participants who had detectable HBeAg (Hepatitis B e Antigens) as measured by a local laboratory
1147381|NCT00441974|O3|Outcome|Total|Total of HBeAg+ and HBeAg- participants
1147382|NCT00441974|O2|Outcome|HBeAg- at Baseline|Participants who had undetectable HBeAg as measured by a local laboratory
1147383|NCT00441974|O1|Outcome|HBeAg+ at Baseline|Participants who had detectable HBeAg (Hepatitis B e Antigens) as measured by a local laboratory
1147384|NCT00441974|E1|Reported Event|10 mg Adefovir Dipivoxil|Adefovir Dipivoxil (ADV) 10 mg tablets once daily for 48 weeks
1147385|NCT00441792|B3|Baseline|Total|Total of all reporting groups
1147386|NCT00441792|B2|Baseline|Etomidate|Patients received either etomidate (0.3 mg/kg) or midazolam (0.1 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients’ care, both in the ED and in the ICU, was directed according to the treating physician.
1147387|NCT00441792|B1|Baseline|Midazolam|Patients received either etomidate or midazolam.
1147388|NCT00441792|P2|Participant Flow|Etomidate|Patients received either etomidate (0.3 mg/kg) or midazolam (0.1 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients’ care, both in the ED and in the ICU, was directed according to the treating physician.
1147389|NCT00441792|P1|Participant Flow|Midazolam|Patients received either etomidate or midazolam.
1147390|NCT00441792|O2|Outcome|Etomidate|Patients received etomidate (0.3 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients' care, both in the emergency department and in the intensive care unit, was directed according to the treating physician.
1147432|NCT00441727|O3|Outcome|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
1147433|NCT00441727|O2|Outcome|Esomeproazole 20|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
1147434|NCT00441727|O1|Outcome|Esomeprazole 40|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
1147435|NCT00441727|O3|Outcome|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
1147787|NCT00441285|O3|Outcome|Phase III Trial - Standard ABZ|Main Trial, Arm receiving standard ABZ doses, no PZQ
1147391|NCT00441792|O1|Outcome|Midazolam|Patients received midazolam (0.1 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients' care, both in the emergency department and in the intensive care unit, was directed according to the treating physician.
1147392|NCT00441792|O2|Outcome|Etomidate|Patients received etomidate (0.3 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients' care, both in the emergency department and in the intensive care unit, was directed according to the treating physician.
1147393|NCT00441792|O1|Outcome|Midazolam|Patients received midazolam (0.1 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients' care, both in the emergency department and in the intensive care unit, was directed according to the treating physician.
1147451|NCT00441727|E2|Reported Event|Esomeproazole 20|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
1147452|NCT00441727|E1|Reported Event|Esomeprazole 40|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
1147453|NCT00441701|B11|Baseline|Total|Total of all reporting groups
1147454|NCT00441701|B10|Baseline|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
1147394|NCT00441792|E2|Reported Event|Etomidate|Patients received either etomidate (0.3 mg/kg) or midazolam (0.1 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients’ care, both in the ED and in the ICU, was directed according to the treating physician.
1147395|NCT00441792|E1|Reported Event|Midazolam|Patients received either etomidate or midazolam.
1147396|NCT00441766|B5|Baseline|Total|Total of all reporting groups
1147397|NCT00441766|B4|Baseline|Placebo|Part A: Placebo capsule every 12 hours for 4 weeks
1147398|NCT00441766|B3|Baseline|AGN 203818 3 mg|Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
1147399|NCT00441766|B2|Baseline|AGN 203818 20 mg|Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
1147400|NCT00441766|B1|Baseline|AGN 203818 60 mg|Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
1147401|NCT00441766|P4|Participant Flow|Placebo|Part A: Placebo capsule every 12 hours for 4 weeks
1147402|NCT00441766|P3|Participant Flow|AGN 203818 3 mg|Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
1147403|NCT00441766|P2|Participant Flow|AGN 203818 20 mg|Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
1147404|NCT00441766|P1|Participant Flow|AGN 203818 60 mg|Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
1147405|NCT00441766|O4|Outcome|Placebo|Part A: Placebo capsule every 12 hours for 4 weeks
1147406|NCT00441766|O3|Outcome|AGN 203818 3 mg|Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
1147407|NCT00441766|O2|Outcome|AGN 203818 20 mg|Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
1147408|NCT00441766|O1|Outcome|AGN 203818 60 mg|Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
1147409|NCT00441766|O4|Outcome|Placebo|Part A: Placebo capsule every 12 hours for 4 weeks
1147410|NCT00441766|O3|Outcome|AGN 203818 3 mg|Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
1147411|NCT00441766|O2|Outcome|AGN 203818 20 mg|Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
1147412|NCT00441766|O1|Outcome|AGN 203818 60 mg|Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
1147413|NCT00441766|O4|Outcome|Placebo|Part A: Placebo capsule every 12 hours for 4 weeks
1147414|NCT00441766|O3|Outcome|AGN 203818 3 mg|Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
1147415|NCT00441766|O2|Outcome|AGN 203818 20 mg|Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
1147416|NCT00441766|O1|Outcome|AGN 203818 60 mg|Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
1147417|NCT00441766|O4|Outcome|Placebo|Part A: Placebo capsule every 12 hours for 4 weeks
1147418|NCT00441766|O3|Outcome|AGN 203818 3 mg|Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
1147419|NCT00441766|O2|Outcome|AGN 203818 20 mg|Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
1147420|NCT00441766|O1|Outcome|AGN 203818 60 mg|Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
1147421|NCT00441766|E4|Reported Event|Placebo|Part A: Placebo capsule every 12 hours for 4 weeks
1147422|NCT00441766|E3|Reported Event|AGN 203818 3 mg|Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
1147423|NCT00441766|E2|Reported Event|AGN 203818 20 mg|Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
1147424|NCT00441766|E1|Reported Event|AGN 203818 60 mg|Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
1147425|NCT00441727|B4|Baseline|Total|Total of all reporting groups
1147426|NCT00441727|B3|Baseline|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
1147427|NCT00441727|B2|Baseline|Esomeproazole 20|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
1147428|NCT00441727|B1|Baseline|Esomeprazole 40|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
1147429|NCT00441727|P3|Participant Flow|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
1147436|NCT00441727|O2|Outcome|Esomeproazole 20 mg|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (acetylsalicyclic acid) (75-325 mg)
1147437|NCT00441727|O1|Outcome|Esomeprazole 40 mg|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
1147438|NCT00441727|O3|Outcome|Placbo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
1147439|NCT00441727|O2|Outcome|Esomeprazole 20 mg|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
1147440|NCT00441727|O1|Outcome|Esomeprazole 40 mg|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
1147441|NCT00441727|O3|Outcome|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
1147442|NCT00441727|O2|Outcome|Esomeproazole 20|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
1147443|NCT00441727|O1|Outcome|Esomeprazole 40|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
1147444|NCT00441727|O3|Outcome|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
1147445|NCT00441727|O2|Outcome|Esomeproazole 20|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
1147446|NCT00441727|O1|Outcome|Esomeprazole 40|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
1147447|NCT00441727|O3|Outcome|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
1147448|NCT00441727|O2|Outcome|Esomeproazole 20|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
1147449|NCT00441727|O1|Outcome|Esomeprazole 40|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
1147450|NCT00441727|E3|Reported Event|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
1147455|NCT00441701|B9|Baseline|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
1147456|NCT00441701|B8|Baseline|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
1147457|NCT00441701|B7|Baseline|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
1147458|NCT00441701|B6|Baseline|Part 1: Placebo to Navarixin 30 mg|Cohort 3: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
1147459|NCT00441701|B5|Baseline|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
1147460|NCT00441701|B4|Baseline|Part 1: Placebo to Navarixin 10 mg|Cohort 2: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
1147461|NCT00441701|B3|Baseline|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
1147462|NCT00441701|B2|Baseline|Part 1: Placebo to Navarixin 3 mg|Cohort 1: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
1147463|NCT00441701|B1|Baseline|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
1147464|NCT00441701|P10|Participant Flow|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
1147465|NCT00441701|P9|Participant Flow|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
1147466|NCT00441701|P8|Participant Flow|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
1147467|NCT00441701|P7|Participant Flow|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
1147468|NCT00441701|P6|Participant Flow|Part 1: Placebo to Navarixin 30 mg|Cohort 3: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
1147469|NCT00441701|P5|Participant Flow|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
1147470|NCT00441701|P4|Participant Flow|Part 1: Placebo to Navarixin 10 mg|Cohort 2: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
1147471|NCT00441701|P3|Participant Flow|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
1147472|NCT00441701|P2|Participant Flow|Part 1: Placebo to Navarixin 3 mg|Cohort 1: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
1147473|NCT00441701|P1|Participant Flow|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) once daily (QD) for up to 12 weeks
1147474|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
1147475|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
1147476|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
1147477|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
1147478|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
1147479|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
1147480|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
1147481|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
1147482|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
1147483|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
1147484|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
1147485|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
1147486|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
1147487|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
1147488|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
1147489|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
1147490|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
1147491|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
1147492|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
1147493|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
1147494|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
1147495|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
1147496|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
1147497|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
1147498|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
1147679|NCT00441363|B1|Baseline|Cycloset|0.8 mg tablet
1147499|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
1147500|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
1147501|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
1147502|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
1147503|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
1147504|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
1147505|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
1147506|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
1147507|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
1147508|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
1147509|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
1147510|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
1147511|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
1147512|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
1147513|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
1147514|NCT00441701|O4|Outcome|Part 1: Placebo to Navarixin (Pooled)|Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
1147515|NCT00441701|O3|Outcome|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
1147516|NCT00441701|O2|Outcome|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
1147517|NCT00441701|O1|Outcome|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
1147518|NCT00441701|O4|Outcome|Part 1: Placebo to Navarixin (Pooled)|Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
1147519|NCT00441701|O3|Outcome|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
1147520|NCT00441701|O2|Outcome|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
1147521|NCT00441701|O1|Outcome|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
1147522|NCT00441701|O4|Outcome|Part 1: Placebo to Navarixin (Pooled)|Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
1147523|NCT00441701|O3|Outcome|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
1147524|NCT00441701|O2|Outcome|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
1147525|NCT00441701|O1|Outcome|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
1147526|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
1147527|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
1147528|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
1147529|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
1147530|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
1147531|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
1147532|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
1147533|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
1147534|NCT00441701|O4|Outcome|Part 1: Placebo to Navarixin (Pooled)|Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
1147535|NCT00441701|O3|Outcome|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
1147536|NCT00441701|O2|Outcome|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
1147537|NCT00441701|O1|Outcome|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
1147538|NCT00441701|O4|Outcome|Part 1: Placebo to Navarixin (Pooled)|Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
1147539|NCT00441701|O3|Outcome|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
1147540|NCT00441701|O2|Outcome|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
1147541|NCT00441701|O1|Outcome|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
1147542|NCT00441701|O4|Outcome|Part 1: Placebo to Navarixin (Pooled)|Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
1147680|NCT00441363|P2|Participant Flow|Placebo|matching placebo
1147543|NCT00441701|O3|Outcome|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
1147544|NCT00441701|O2|Outcome|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
1147545|NCT00441701|O1|Outcome|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
1147546|NCT00441701|E8|Reported Event|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
1147547|NCT00441701|E7|Reported Event|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
1147548|NCT00441701|E6|Reported Event|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
1147549|NCT00441701|E5|Reported Event|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
1147550|NCT00441701|E4|Reported Event|Part 1: Placebo to Navarixin (Pooled)|Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
1147551|NCT00441701|E3|Reported Event|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
1147552|NCT00441701|E2|Reported Event|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
1147553|NCT00441701|E1|Reported Event|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
1147554|NCT00441584|B1|Baseline|PegIntron Plus Rebetol|PegIntron 1.5 μg/kg/week plus Rebetol 800-1400 mg/day administered for 48 weeks
1147555|NCT00441584|P1|Participant Flow|PegIntron Plus Rebetol|PegIntron 1.5 μg/kg/week plus Rebetol 800-1400 mg/day administered for 48 weeks
1147556|NCT00441584|O1|Outcome|PegIntron Plus Rebetol|PegIntron 1.5 μg/kg/week plus Rebetol 800-1400 mg/day administered for 48 weeks
1147557|NCT00441584|E1|Reported Event|PegIntron Plus REBETOL|
1147558|NCT00441558|B1|Baseline|Flibanserin|Flibanserin: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
1147559|NCT00441558|P1|Participant Flow|Flibanserin|Flibanserin: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
1147560|NCT00441558|O1|Outcome|Flibanserin|Flibanserin: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
1147561|NCT00441558|E1|Reported Event|Flibanserin|Flibanserin: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
1147562|NCT00441545|B1|Baseline|Entire Study Population|
1147563|NCT00441545|P2|Participant Flow|Sevelamer HCl First|Sevelamer HCl dosing began at 4800mg/day, administered orally as two 800mg tablets taken three times per day with meals for 1 week. After receiving this dose for 1 week, subjects received the final dose of 6400mg/day, administered orally as three 800mg tablets taken two times per day with meals and two 800mg tablets taken once per day with the lighter meal (i.e., a total of eight 800mg tablets per day). Subjects were to remain on the final sevelamer HCl dose of 6400mg/day for 3 weeks. After washout, patients then crossover to receive Fosrenol for 4 weeks (see above).
1147564|NCT00441545|P1|Participant Flow|Fosrenol First|Fosrenol (Lanthanum carbonate) dosing began at 2250mg/day, administered orally as one 750mg tablet taken three times per day with meals for 1 week. After receiving this dose for 1 week, subjects received the final dose of 3000mg/day, administered orally as one 1000mg tablet three times per day with meals. Subjects were to remain on the final Fosrenol dose of 3000mg/day for 3 weeks. After washout, patients then crossover to receive Sevelamer HCl for 4 weeks (see below).
1147565|NCT00441545|O2|Outcome|Sevelamer HCl|
1147566|NCT00441545|O1|Outcome|Fosrenol|Lanthanum carbonate
1147567|NCT00441545|O2|Outcome|Sevelamer HCl|
1147568|NCT00441545|O1|Outcome|Fosrenol|Lanthanum carbonate
1147573|NCT00441545|E2|Reported Event|Sevelamer HCl|Sevelamer HCl dosing began at 4800mg/day, administered orally as two 800mg tablets taken three times per day with meals for 1 week. After receiving this dose for 1 week, subjects received the final dose of 6400mg/day, administered orally as three 800mg tablets taken two times per day with meals and two 800mg tablets taken once per day with the lighter meal (i.e., a total of eight 800mg tablets per day). Subjects were to remain on the final sevelamer HCl dose of 6400mg/day for 3 weeks. After washout, patients then crossover to receive Fosrenol for 4 weeks (see above).
1147574|NCT00441545|E1|Reported Event|Fosrenol|Fosrenol (Lanthanum carbonate) dosing began at 2250mg/day, administered orally as one 750mg tablet taken three times per day with meals for 1 week. After receiving this dose for 1 week, subjects received the final dose of 3000mg/day, administered orally as one 1000mg tablet three times per day with meals. Subjects were to remain on the final Fosrenol dose of 3000mg/day for 3 weeks. After washout, patients then crossover to receive Sevelamer HCl for 4 weeks (see below).
1147575|NCT00441480|B3|Baseline|Total|Total of all reporting groups
1147576|NCT00441480|B2|Baseline|Control|Corn oil
1147577|NCT00441480|B1|Baseline|PS-FO|plant sterols esterified to fish oil fatty acids
1147578|NCT00441480|P2|Participant Flow|Control|Corn oil
1147579|NCT00441480|P1|Participant Flow|PS-FO|plant sterols esterified to fish oil fatty acids
1147580|NCT00441480|O2|Outcome|Control|Corn oil
1147581|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
1147582|NCT00441480|O2|Outcome|Control|Corn oil
1147583|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
1147584|NCT00441480|O2|Outcome|Control|Corn oil
1147585|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
1147586|NCT00441480|O2|Outcome|Control|Corn oil
1147587|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
1147588|NCT00441480|O2|Outcome|Control|Corn oil
1147589|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
1147590|NCT00441480|O2|Outcome|Control|Corn oil
1147591|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
1147592|NCT00441480|O2|Outcome|Control|Corn oil
1147593|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
1147594|NCT00441480|O2|Outcome|Control|Corn oil
1147603|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
1147604|NCT00441480|O2|Outcome|Control|Corn oil
1147605|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
1147606|NCT00441480|O2|Outcome|Control|Corn oil
1147607|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
1147608|NCT00441480|E2|Reported Event|Control|Corn oil
1147609|NCT00441480|E1|Reported Event|PS-FO|plant sterols esterified to fish oil fatty acids
1147610|NCT00441467|B1|Baseline|Glufosfamide|"Glufosfamide~Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles."
1147611|NCT00441467|P1|Participant Flow|Glufosfamide|"Glufosfamide~Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles."
1147612|NCT00441467|O1|Outcome|Glufosfamide|"Glufosfamide~Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles."
1147613|NCT00441467|O1|Outcome|Glufosfamide|"Glufosfamide~Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles."
1147614|NCT00441467|O1|Outcome|Glufosfamide|"Glufosfamide~Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles."
1147615|NCT00441467|E1|Reported Event|Glufosfamide|"Glufosfamide~Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles."
1147616|NCT00441441|B3|Baseline|Total|Total of all reporting groups
1147617|NCT00441441|B2|Baseline|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
1147618|NCT00441441|B1|Baseline|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
1147619|NCT00441441|P2|Participant Flow|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
1147620|NCT00441441|P1|Participant Flow|Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA)|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
1147621|NCT00441441|O2|Outcome|No Spacer|Participants who required a spacer and were in either treatment group
1147622|NCT00441441|O1|Outcome|Spacer|Participants who did not use spacer and were in either treatment group
1147623|NCT00441441|O2|Outcome|Spacer|Participants who required a spacer and were in either treatment group
1147624|NCT00441441|O1|Outcome|No Spacer|Participants who did not use spacer and were in either treatment group
1147625|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Samples provided by participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
1147626|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Samples provided by participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
1147627|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Samples provided by participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
1147628|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Samples provided by participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
1147629|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
1147630|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
1147631|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
1147632|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
1147633|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
1147634|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
1147635|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
1147636|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
1147637|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
1147638|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
1147639|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
1147640|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
1147641|NCT00441441|O4|Outcome|Fluticasone Propionate HFA - No Spacer|Fluticasone Propionate 100 µg HFA (2 inhalation of 50 µg) twice daily in participants 4-11 years of age for 12 weeks
1147642|NCT00441441|O3|Outcome|Fluticasone Propionate HFA - Spacer|Fluticasone Propionate 100 µg HFA (2 inhalation of 50 µg) twice daily in participants 4-11 years of age for 12 weeks. Participants who also used Spacers
1147643|NCT00441441|O2|Outcome|Fluticasone Propionate/Salmeterol HFA - No Spacer|Fluticasone propionate/salmeterol 100/50 µg HFA (2 inhalations of 50/25 µg) twice daily in participants 4-11 years of age for 12 weeks
1147644|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA - Spacer|Fluticasone propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg) twice daily in participants 4-11 years of age for 12 weeks - Participants who also used Spacers
1147645|NCT00441441|O4|Outcome|Fluticasone Propionate HFA - No Spacer|Fluticasone Propionate 100 µg HFA (2 inhalation of 50 µg) twice daily in participants 4-11 years of age for 12 weeks
1147646|NCT00441441|O3|Outcome|Fluticasone Propionate HFA - Spacer|Fluticasone Propionate 100 µg HFA (2 inhalation of 50 µg) twice daily in participants 4-11 years of age for 12 weeks. Participants who also used Spacers
1147647|NCT00441441|O2|Outcome|Fluticasone Propionate/Salmeterol HFA - No Spacer|Fluticasone propionate/salmeterol 100/50 µg HFA (2 inhalations of 50/25 µg) twice daily in participants 4-11 years of age for 12 weeks
1147648|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA - Spacer|Fluticasone propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg) twice daily in participants 4-11 years of age for 12 weeks - Participants who also used Spacers
1147649|NCT00441441|O4|Outcome|Fluticasone Propionate HFA - No Spacer|Fluticasone Propionate 100 µg HFA (2 inhalation of 50 µg) twice daily in participants 4-11 years of age for 12 weeks
1147650|NCT00441441|O3|Outcome|Fluticasone Propionate HFA - Spacer|Fluticasone Propionate 100 µg HFA (2 inhalation of 50 µg) twice daily in participants 4-11 years of age for 12 weeks. Participants who also used Spacers
1147651|NCT00441441|O2|Outcome|Fluticasone Propionate/Salmeterol HFA - No Spacer|Fluticasone propionate/salmeterol 100/50 µg HFA (2 inhalations of 50/25 µg) twice daily in participants 4-11 years of age for 12 weeks
1147652|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA - Spacer|Fluticasone propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25µg) twice daily in participants 4-11 years of age for 12 weeks - Participants who also used Spacers
1147653|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
1147654|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
1147655|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
1147656|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
1147657|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
1147658|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
1147659|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
1147660|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
1147661|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
1147662|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 µg HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
1147663|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
1147664|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
1147665|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone propionate 100 µg HFA (2inhalations of 50 µg), twice daily for 12 weeks.
1147666|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25µg), twice daily for 12 weeks.
1147667|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
1147668|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25µg), twice daily for 12 weeks.
1147669|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
1147670|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
1147671|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
1147672|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
1147673|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
1147674|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
1147675|NCT00441441|E2|Reported Event|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
1147676|NCT00441441|E1|Reported Event|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
1147689|NCT00441337|B4|Baseline|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
1147690|NCT00441337|B3|Baseline|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
1147691|NCT00441337|B2|Baseline|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
1147692|NCT00441337|B1|Baseline|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
1147782|NCT00441285|P2|Participant Flow|PK Substudy ABZ+Placebo|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days."
1156705|NCT00420017|O2|Outcome|Control|Control usual care
1147693|NCT00441337|P4|Participant Flow|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
1147694|NCT00441337|P3|Participant Flow|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
1147695|NCT00441337|P2|Participant Flow|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
1147696|NCT00441337|P1|Participant Flow|0.3 mg/kg Nivolumab|0.3 milligrams (mg) of nivolumab per kilogram (kg) of body weight (mg/kg) was administered in a single intravenous (IV) infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
1147697|NCT00441337|O3|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147698|NCT00441337|O2|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147699|NCT00441337|O1|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147836|NCT00441168|B1|Baseline|VAD Treatment|vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
1147700|NCT00441337|O3|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147701|NCT00441337|O2|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147702|NCT00441337|O1|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147703|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147704|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147788|NCT00441285|O2|Outcome|Phase III Trial - Increased ABZ|Main Trial, Arm receiving increased ABZ doses, no PZQ
1147789|NCT00441285|O1|Outcome|Phase III Trial - ABZ+PZQ|Main Trial, Arm receiving standard ABZ doses plus active PZQ
1147705|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147706|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147707|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147708|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147709|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147710|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147711|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147837|NCT00441168|P2|Participant Flow|PAD Treatment|bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
1147712|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147713|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147714|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147715|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147716|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147717|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147718|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147719|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147720|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147721|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147722|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147723|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147796|NCT00441285|O1|Outcome|Albendazole + Praziquantel|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
1147724|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147725|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147726|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147727|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147728|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147729|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147730|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147731|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147732|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147733|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147734|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147735|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147797|NCT00441285|O2|Outcome|Phenytoin|Area Under the Curve of Praziquantel in Patients Receiving Phenytoin
1147798|NCT00441285|O1|Outcome|Carbamazepine|Area Under the Curve of Praziquantel in Patients Receiving Carbamazepine
1147838|NCT00441168|P1|Participant Flow|VAD Treatment|vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
1147736|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147737|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147738|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147739|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147740|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147741|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147742|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147743|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147744|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147745|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147746|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147747|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147799|NCT00441285|O1|Outcome|Albendazole + Praziquantel|"Albendazole was given at 15 mg/kg/day, divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg/day, for 10 days.~Praziquantel was given at 50 mg/kg/day, divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g/day,for 9 1/2 days."
1147748|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147749|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147750|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147751|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147752|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147753|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147754|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147755|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147783|NCT00441285|P1|Participant Flow|PK Substudy ABZ+PZQ|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
1147756|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147757|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147758|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147759|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147760|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147761|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147762|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147763|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147764|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1147765|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
1147766|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
1147767|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
1147784|NCT00441285|O3|Outcome|Phase III Trial - Standard ABZ|Main Trial, Arm receiving standard ABZ doses, no PZQ
1147785|NCT00441285|O2|Outcome|Phase III Trial - Increased ABZ|Main Trial, Arm receiving increased ABZ doses, no PZQ
1148125|NCT00440531|O3|Outcome|ENGERIX-B™|ENGERIX-B™, 20 µg (micrograms)
1147768|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
1147769|NCT00441337|E4|Reported Event|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
1147770|NCT00441337|E3|Reported Event|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
1147800|NCT00441285|O2|Outcome|Albendazole + Placebo|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days."
1147771|NCT00441337|E2|Reported Event|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
1147772|NCT00441337|E1|Reported Event|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
1147773|NCT00441285|B6|Baseline|Total|Total of all reporting groups
1147774|NCT00441285|B5|Baseline|Phase III Trial Standard ABZ|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~A placebo of ABZ was added to complete the doses to the dosage in the Increased ABZ arm~Praziquantel placebo was given in two daily doses, morning and evening,for 10 days."
1147775|NCT00441285|B4|Baseline|Phase III Trial Increased ABZ|"Albendazole was given at 22.5 mg / kg / d , divided in two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum of 1200 mg / d , for 10 days.~Praziquantel placebo was given in two daily doses, morning and evening,for 10 days."
1147776|NCT00441285|B3|Baseline|Phase III Trial ABZ+PZQ|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~A placebo of ABZ was added to complete to the doses in the Increased ABZ arm~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 10 days."
1147777|NCT00441285|B2|Baseline|Albendazole + Placebo|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days."
1147778|NCT00441285|B1|Baseline|Albendazole + Praziquantel|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
1147779|NCT00441285|P5|Participant Flow|Phase III Trial - Standard ABZ|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Placebo of ABZ was added to mask the dose of ABZ (see Increased ABZ arm)~Placebo of Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
1147780|NCT00441285|P4|Participant Flow|Phase III Trial - Increased ABZ|"Albendazole was given at 22.5 mg / kg / d , divided in two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum of 1200 mg / d, for 10 days.~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening. It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
1147781|NCT00441285|P3|Participant Flow|Phase III Trial - ABZ+PZQ|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Placebo of ABZ was added to mask the dose of ABZ (see Increased ABZ arm)~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
1147786|NCT00441285|O1|Outcome|Phase III Trial - ABZ+PZQ|Main Trial, Arm receiving standard ABZ doses plus active PZQ
1147790|NCT00441285|O3|Outcome|Phase III Trial - Standard ABZ|Main Trial, Arm receiving standard ABZ doses, no PZQ
1147791|NCT00441285|O2|Outcome|Phase III Trial - Increased ABZ|Main Trial, Arm receiving increased ABZ doses, no PZQ
1147792|NCT00441285|O1|Outcome|Phase III Trial - ABZ+PZQ|Main Trial, Arm receiving standard ABZ doses plus active PZQ
1147793|NCT00441285|O2|Outcome|Albendazole + Placebo|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days."
1147794|NCT00441285|O1|Outcome|Albendazole + Praziquantel|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
1147795|NCT00441285|O2|Outcome|Albendazole + Placebo|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days."
1147834|NCT00441168|B3|Baseline|Total|Total of all reporting groups
1147835|NCT00441168|B2|Baseline|PAD Treatment|bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
1147801|NCT00441285|O1|Outcome|Albendazole + Praziquantel|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
1147802|NCT00441285|O2|Outcome|Albendazole + Placebo|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days."
1147803|NCT00441285|O1|Outcome|Albendazole + Praziquantel|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
1147804|NCT00441285|E2|Reported Event|Albendazole + Placebo|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days."
1147805|NCT00441285|E1|Reported Event|Albendazole + Praziquantel|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
1147806|NCT00441272|B3|Baseline|Total|Total of all reporting groups
1147807|NCT00441272|B2|Baseline|Pioglitazone 45mg/Day|Those participants receiveing Pioglitazone 45mg/day for 48 weeks.
1147808|NCT00441272|B1|Baseline|Placebo|Those participants receiving placebo for 48 weeks
1147809|NCT00441272|P2|Participant Flow|Pioglitazone 45mg/Day|Those participants receiveing Pioglitazone 45mg/day for 48 weeks.
1147810|NCT00441272|P1|Participant Flow|Placebo|Those participants receiving placebo for 48 weeks
1147811|NCT00441272|O2|Outcome|Pioglitazone 45mg/Day|Those participants receiveing Pioglitazone 45mg/day for 48 weeks.
1147812|NCT00441272|O1|Outcome|Placebo|Those participants receiving placebo for 48 weeks
1147813|NCT00441272|E2|Reported Event|Pioglitazone 45mg/Day|Those participants receiveing Pioglitazone 45mg/day for 48 weeks.
1147814|NCT00441272|E1|Reported Event|Placebo|Those participants receiving placebo for 48 weeks
1147815|NCT00441259|B3|Baseline|Total|Total of all reporting groups
1147816|NCT00441259|B2|Baseline|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
1147817|NCT00441259|B1|Baseline|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
1147818|NCT00441259|P2|Participant Flow|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
1148007|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
1147819|NCT00441259|P1|Participant Flow|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
1147820|NCT00441259|O2|Outcome|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
1147821|NCT00441259|O1|Outcome|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
1147822|NCT00441259|O2|Outcome|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
1147823|NCT00441259|O1|Outcome|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
1147824|NCT00441259|O2|Outcome|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
1147825|NCT00441259|O1|Outcome|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
1147826|NCT00441259|O2|Outcome|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
1147827|NCT00441259|O1|Outcome|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
1147828|NCT00441259|O2|Outcome|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
1147829|NCT00441259|O1|Outcome|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
1147830|NCT00441259|O2|Outcome|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
1147831|NCT00441259|O1|Outcome|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
1147832|NCT00441259|E2|Reported Event|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
1147833|NCT00441259|E1|Reported Event|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
1147839|NCT00441168|O2|Outcome|PAD Treatment|bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
1147840|NCT00441168|O1|Outcome|VAD Treatment|vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
1147841|NCT00441168|O2|Outcome|PAD Treatment|bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
1147842|NCT00441168|O1|Outcome|VAD Treatment|vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
1147843|NCT00441168|O2|Outcome|PAD Treatment|bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
1147844|NCT00441168|O1|Outcome|VAD Treatment|vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
1147845|NCT00441168|E2|Reported Event|PAD Treatment|bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
1147846|NCT00441168|E1|Reported Event|VAD Treatment|vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
1147847|NCT00441142|B5|Baseline|Total|Total of all reporting groups
1147848|NCT00441142|B4|Baseline|Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib)|"The Induction Phase:~ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant’s RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
1148124|NCT00440531|P1|Participant Flow|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
1147849|NCT00441142|B3|Baseline|Phase II: Arm A (Control Group: RT + TMZ)|"The Induction Phase:~Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given]."
1147850|NCT00441142|B2|Baseline|Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
1147851|NCT00441142|B1|Baseline|Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
1147852|NCT00441142|P4|Participant Flow|Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib)|"The Induction Phase:~ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant’s RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
1147904|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147905|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
1147906|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147853|NCT00441142|P3|Participant Flow|Phase II: Arm A (Control Group: RT + TMZ)|"The Induction Phase:~Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given]."
1147854|NCT00441142|P2|Participant Flow|Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
1147855|NCT00441142|P1|Participant Flow|Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
1147856|NCT00441142|O4|Outcome|Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib)|"The Induction Phase:~ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant’s RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
1148008|NCT00440947|O1|Outcome|ABC/3TC + ATV/r: Induction Phase|Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
1147857|NCT00441142|O3|Outcome|Phase II: Arm A (Control Group: RT + TMZ)|"The Induction Phase:~Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given]."
1147858|NCT00441142|O2|Outcome|Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
1147859|NCT00441142|O1|Outcome|Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
1147860|NCT00441142|O4|Outcome|Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib)|"The Induction Phase:~ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant’s RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
1147861|NCT00441142|O3|Outcome|Phase II: Arm A (Control Group: RT + TMZ)|"The Induction Phase:~Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given]."
1147862|NCT00441142|O2|Outcome|Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
1147863|NCT00441142|O1|Outcome|Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
1147864|NCT00441142|O4|Outcome|Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib)|"The Induction Phase:~ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant’s RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
1147886|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147865|NCT00441142|O3|Outcome|Phase II: Arm A (Control Group: RT + TMZ)|"The Induction Phase:~Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given]."
1147866|NCT00441142|O2|Outcome|Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
1147867|NCT00441142|O1|Outcome|Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
1147868|NCT00441142|E2|Reported Event|Phase II-Arm A Pts (Control Group): RT + TMZ|"The Induction Phase:~Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given]."
1147907|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
1147947|NCT00441103|O1|Outcome|Rebif® New Formulation (IFN-beta-1a, RNF)|RNF 44 mcg administered subcutaneously three times a week for 40 weeks.
1147869|NCT00441142|E1|Reported Event|Phase I & Phase II-Arm B Pts: RT + TMZ + Vandetanib|"The Induction Phase:~ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant’s RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
1147870|NCT00441116|B3|Baseline|Total|Total of all reporting groups
1147871|NCT00441116|B2|Baseline|Placebo|Subjects who were given no Investigational product.
1147872|NCT00441116|B1|Baseline|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147873|NCT00441116|P2|Participant Flow|Placebo|Subjects who were given no Investigational product.
1147874|NCT00441116|P1|Participant Flow|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147875|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
1147876|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147877|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
1147878|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147879|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
1147880|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147881|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
1147882|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147883|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
1147884|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147885|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
1147887|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
1148120|NCT00440531|B2|Baseline|RECOMBIVAX-HB™|RECOMBIVAX-HB™, 10 µg (micrograms)
1147888|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147889|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
1147890|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147891|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
1147892|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147893|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
1147894|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147895|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
1147896|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147897|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
1147898|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147899|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
1147900|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147901|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
1147902|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147903|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
1147946|NCT00441103|O2|Outcome|Placebo/RNF|Matching placebo administered subcutaneously three times a week for 16 weeks, followed by RNF 44 mcg administered subcutaneously three times a week for subsequent 24 weeks.
1147908|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147909|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
1147910|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147911|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
1147912|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147913|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
1147914|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147915|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
1147916|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147917|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
1147918|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147919|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
1147920|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147921|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
1147922|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147923|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
1147924|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147925|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
1148222|NCT00440401|B2|Baseline|Standard Treatment|
1147926|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147927|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
1147928|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147929|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
1147930|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147931|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
1147932|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147933|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
1147934|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147935|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
1147936|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147937|NCT00441116|E2|Reported Event|Placebo|Subjects who were given no Investigational product.
1147938|NCT00441116|E1|Reported Event|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
1147939|NCT00441103|B3|Baseline|Total|Total of all reporting groups
1147940|NCT00441103|B2|Baseline|Placebo/RNF|Matching placebo administered subcutaneously three times a week for 16 weeks, followed by RNF 44 mcg administered subcutaneously three times a week for subsequent 24 weeks.
1147941|NCT00441103|B1|Baseline|Rebif® New Formulation (IFN-beta-1a, RNF)|RNF 44 mcg administered subcutaneously three times a week for 40 weeks.
1147942|NCT00441103|P2|Participant Flow|Placebo/RNF|Matching placebo administered subcutaneously three times a week for 16 weeks, followed by RNF 44 mcg administered subcutaneously three times a week for subsequent 24 weeks.
1147943|NCT00441103|P1|Participant Flow|Rebif® New Formulation (IFN-beta-1a, RNF)|RNF 44 microgram (mcg) administered subcutaneously three times a week for 40 weeks.
1147944|NCT00441103|O2|Outcome|Placebo/RNF|Matching placebo administered subcutaneously three times a week for 16 weeks, followed by RNF 44 mcg administered subcutaneously three times a week for subsequent 24 weeks.
1147945|NCT00441103|O1|Outcome|Rebif® New Formulation (IFN-beta-1a, RNF)|RNF 44 mcg administered subcutaneously three times a week for 40 weeks.
1147948|NCT00441103|O1|Outcome|Placebo/RNF|Matching placebo administered subcutaneously three times a week for 16 weeks, followed by RNF 44 mcg administered subcutaneously three times a week for subsequent 24 weeks.
1147949|NCT00441103|O2|Outcome|Placebo/RNF|Matching placebo administered subcutaneously three times a week for 16 weeks, followed by RNF 44 mcg administered subcutaneously three times a week for subsequent 24 weeks.
1147950|NCT00441103|O1|Outcome|Rebif® New Formulation (IFN-beta-1a, RNF)|RNF 44 mcg administered subcutaneously three times a week for 40 weeks.
1147951|NCT00441103|E2|Reported Event|Placebo/RNF|Matching placebo administered subcutaneously three times a week for 16 weeks, followed by RNF 44 mcg administered subcutaneously three times a week for subsequent 24 weeks.
1147952|NCT00441103|E1|Reported Event|Rebif® New Formulation (IFN-beta-1a, RNF)|RNF 44 mcg administered subcutaneously three times a week for 40 weeks.
1147953|NCT00441064|B3|Baseline|Total|Total of all reporting groups
1147954|NCT00441064|B2|Baseline|Diet Sequence High/Low Sodium|Patients on high sodium (>= 200 mmol/day) diet for the first 4 weeks and on low sodium diet ( <= 100 mmol/day) for the next 4 weeks. [with Aliskiren 300 mg]
1147955|NCT00441064|B1|Baseline|Diet Sequence Low/High Sodium|Patients on low sodium diet ( <= 100 mmol/day) for the first 4 weeks and high sodium (>= 200 mmol/day) diet for the next 4 weeks. [with Aliskiren 300 mg]
1147956|NCT00441064|P2|Participant Flow|Diet Sequence High/Low Sodium|Patients on high sodium (>= 200 mmol/day) diet for the first 4 weeks and crossed over to the low sodium diet ( <= 100 mmol/day) for the next 4 weeks. [with Aliskiren 300 mg]
1147957|NCT00441064|P1|Participant Flow|Diet Sequence Low/High Sodium|Patients on low sodium diet ( <= 100 mmol/day) for the first 4 weeks who crossed over to the high sodium (>= 200 mmol/day) diet for the next 4 weeks. [with Aliskiren 300 mg]
1147958|NCT00441064|O2|Outcome|High Sodium Diet|All patients who were on high sodium (>= 200 mmol/day) diet
1147959|NCT00441064|O1|Outcome|Low Sodium Diet|All patients who were on low sodium (<= 100 mmol/day) diet
1147960|NCT00441064|O2|Outcome|High Sodium Diet|All patients who were on high sodium (>= 200 mmol/day) diet
1147961|NCT00441064|O1|Outcome|Low Sodium Diet|All patients who were on low sodium (<= 100 mmol/day) diet
1147962|NCT00441064|O2|Outcome|High Sodium Diet|All patients who were on high sodium (>= 200 mmol/day) diet
1147963|NCT00441064|O1|Outcome|Low Sodium Diet|All patients who were on low sodium (<= 100 mmol/day) diet
1147964|NCT00441064|E2|Reported Event|High Sodium Diet|All patients who were on high sodium (>= 200 mmol/day) diet.
1147965|NCT00441064|E1|Reported Event|Low Sodium Diet|All patients who were on low sodium (<= 100 mmol/day) diet.
1147966|NCT00441012|B3|Baseline|Total|Total of all reporting groups
1148223|NCT00440401|B1|Baseline|TachoSil®|
1147967|NCT00441012|B2|Baseline|COMVAX™|"COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)~3 participants in the COMVAX™ group vaccinated but not randomized; overall N is 276, not 273 - due to issues randomizing via IVRS, in violation, all 3 participants were vaccinated as randomly assigned by the Investigator."
1147968|NCT00441012|B1|Baseline|Modified Process Vaccine|"Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)~1 participant randomized but not vaccinated in the Modified Process Vaccine group; overall N is 269, not 270."
1147969|NCT00441012|P2|Participant Flow|COMVAX™|COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
1147970|NCT00441012|P1|Participant Flow|Modified Process Vaccine|Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
1147971|NCT00441012|O2|Outcome|COMVAX™|COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
1147972|NCT00441012|O1|Outcome|Modified Process Vaccine|Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
1147973|NCT00441012|O2|Outcome|COMVAX™|COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
1147974|NCT00441012|O1|Outcome|Modified Process Vaccine|Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
1147975|NCT00441012|O2|Outcome|COMVAX™|COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
1147976|NCT00441012|O1|Outcome|Modified Process Vaccine|Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
1147977|NCT00441012|O2|Outcome|COMVAX™|COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
1147978|NCT00441012|O1|Outcome|Modified Process Vaccine|Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
1147979|NCT00441012|O2|Outcome|COMVAX™|COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
1147980|NCT00441012|O1|Outcome|Modified Process Vaccine|Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
1147981|NCT00441012|E2|Reported Event|COMVAX™|COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
1147982|NCT00441012|E1|Reported Event|Modified Process Vaccine|Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
1147983|NCT00440947|B1|Baseline|ABC/3TC + ATV/r|All participants starting the Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
1147984|NCT00440947|P5|Participant Flow|ABC/3TC + ATV/r: Extension Phase|Continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
1147985|NCT00440947|P4|Participant Flow|ABC/3TC + ATV: Extension Phase|Simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
1147986|NCT00440947|P3|Participant Flow|ABC/3TC + ATV/r: Randomization Phase|Continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
1147987|NCT00440947|P2|Participant Flow|ABC/3TC + ATV: Randomization Phase|Simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with 400 mg ATV QD
1147988|NCT00440947|P1|Participant Flow|ABC/3TC + ATV/r: Induction Phase|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 300 mg QD + ritonavir (/r) 100 mg QD during the first 36 weeks of the study (planned interim analysis)
1147989|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Extension Phase|Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
1147990|NCT00440947|O1|Outcome|ABC/3TC + ATV: Extension Phase|Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
1148101|NCT00440557|O2|Outcome|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
1147991|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
1147992|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
1147993|NCT00440947|O1|Outcome|ABC/3TC + ATV/r: Induction Phase|Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
1147994|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Extension Phase|Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
1147995|NCT00440947|O1|Outcome|ABC/3TC + ATV: Extension Phase|Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
1147996|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
1147997|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
1147998|NCT00440947|O1|Outcome|ABC/3TC + ATV/r: Induction Phase|Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
1147999|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Extension Phase|Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
1148000|NCT00440947|O1|Outcome|ABC/3TC + ATV: Extension Phase|Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
1148001|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
1148002|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
1148003|NCT00440947|O1|Outcome|ABC/3TC + ATV/r: Induction Phase|Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
1148004|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Extension Phase|Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
1148005|NCT00440947|O1|Outcome|ABC/3TC + ATV: Extension Phase|Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
1148006|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
1148009|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Extension Phase|Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
1148010|NCT00440947|O1|Outcome|ABC/3TC + ATV: Extension Phase|Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
1148011|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
1148012|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
1148013|NCT00440947|O1|Outcome|ABC/3TC + ATV/r: Induction Phase|Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
1148014|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Extension Phase|Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
1148015|NCT00440947|O1|Outcome|ABC/3TC + ATV: Extension Phase|Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
1148016|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
1148017|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
1148018|NCT00440947|O1|Outcome|ABC/3TC + ATV/r: Induction Phase|Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
1148019|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Extension Phase|Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
1148020|NCT00440947|O1|Outcome|ABC/3TC + ATV: Extension Phase|Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
1148021|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
1148022|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
1148023|NCT00440947|O1|Outcome|ABC/3TC + ATV/r: Induction Phase|Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
1148024|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Extension Phase|Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
1148025|NCT00440947|O1|Outcome|ABC/3TC + ATV: Extension Phase|Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
1148026|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
1148027|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
1148028|NCT00440947|O1|Outcome|ABC/3TC + ATV/r: Induction Phase|Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
1148029|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
1148030|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
1148031|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
1148032|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
1148033|NCT00440947|E5|Reported Event|ABC/3TC + ATV/r: Extension Phase|participants in the Safety Population receiving continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
1148034|NCT00440947|E4|Reported Event|ABC/3TC + ATV: Extension Phase|Extension Phase: participants in the Safety Population receiving a simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
1148035|NCT00440947|E3|Reported Event|ABC/3TC + ATV/r: Randomization Phase|Randomization Phase: participants in the Safety Population receiving continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD; includes SAEs that occurred during induction phase
1148036|NCT00440947|E2|Reported Event|ABC/3TC + ATV: Randomization Phase|Randomization Phase: participants in the Safety Population receiving a simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD; includes serious adverse events (SAEs) that occurred during induction phase
1148037|NCT00440947|E1|Reported Event|ABC/3TC + ATV/r: Induction Phase|Induction Phase: participants in the Safety Population (participants exposed to at least one dose of investigational product) receiving abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 300 mg QD + ritonavir (/r) 100 mg QD during the first 36 weeks of the study (planned interim analysis)
1148038|NCT00440830|B5|Baseline|Total|Total of all reporting groups
1148039|NCT00440830|B4|Baseline|Non-smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
1148040|NCT00440830|B3|Baseline|Non-smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
1148041|NCT00440830|B2|Baseline|Smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
1148042|NCT00440830|B1|Baseline|Smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
1148043|NCT00440830|P4|Participant Flow|Non-smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
1148044|NCT00440830|P3|Participant Flow|Non-smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
1148045|NCT00440830|P2|Participant Flow|Smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
1148046|NCT00440830|P1|Participant Flow|Smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
1148047|NCT00440830|O4|Outcome|Non-smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
1148048|NCT00440830|O3|Outcome|Non-smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
1148049|NCT00440830|O2|Outcome|Smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
1148050|NCT00440830|O1|Outcome|Smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
1148051|NCT00440830|O4|Outcome|Non-smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
1148052|NCT00440830|O3|Outcome|Non-smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
1148053|NCT00440830|O2|Outcome|Smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
1148054|NCT00440830|O1|Outcome|Smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
1148055|NCT00440830|E4|Reported Event|Non-smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
1148056|NCT00440830|E3|Reported Event|Non-smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
1148057|NCT00440830|E2|Reported Event|Smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
1148058|NCT00440830|E1|Reported Event|Smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
1148059|NCT00440700|B4|Baseline|Total|Total of all reporting groups
1148060|NCT00440700|B3|Baseline|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
1148061|NCT00440700|B2|Baseline|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
1148062|NCT00440700|B1|Baseline|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
1148063|NCT00440700|P3|Participant Flow|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
1148064|NCT00440700|P2|Participant Flow|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
1148065|NCT00440700|P1|Participant Flow|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
1148066|NCT00440700|O3|Outcome|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
1148067|NCT00440700|O2|Outcome|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
1148068|NCT00440700|O1|Outcome|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
1148069|NCT00440700|O3|Outcome|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
1148070|NCT00440700|O2|Outcome|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
1148071|NCT00440700|O1|Outcome|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
1148072|NCT00440700|O3|Outcome|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
1148073|NCT00440700|O2|Outcome|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
1148074|NCT00440700|O1|Outcome|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
1148075|NCT00440700|O3|Outcome|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
1148076|NCT00440700|O2|Outcome|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
1148077|NCT00440700|O1|Outcome|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
1148078|NCT00440700|O3|Outcome|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
1148079|NCT00440700|O2|Outcome|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
1148121|NCT00440531|B1|Baseline|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
1148080|NCT00440700|O1|Outcome|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
1148081|NCT00440700|E3|Reported Event|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
1148082|NCT00440700|E2|Reported Event|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
1148083|NCT00440700|E1|Reported Event|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
1148084|NCT00440557|B4|Baseline|Total|Total of all reporting groups
1148085|NCT00440557|B3|Baseline|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
1148086|NCT00440557|B2|Baseline|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
1148087|NCT00440557|B1|Baseline|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
1148088|NCT00440557|P3|Participant Flow|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
1148089|NCT00440557|P2|Participant Flow|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
1148090|NCT00440557|P1|Participant Flow|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
1148091|NCT00440557|O3|Outcome|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
1148092|NCT00440557|O2|Outcome|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
1148093|NCT00440557|O1|Outcome|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
1148094|NCT00440557|O3|Outcome|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
1148095|NCT00440557|O2|Outcome|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
1148096|NCT00440557|O1|Outcome|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
1148097|NCT00440557|O3|Outcome|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
1148098|NCT00440557|O2|Outcome|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
1148099|NCT00440557|O1|Outcome|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
1148100|NCT00440557|O3|Outcome|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
1148497|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
1148102|NCT00440557|O1|Outcome|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
1148103|NCT00440557|O3|Outcome|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
1148104|NCT00440557|O2|Outcome|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
1148105|NCT00440557|O1|Outcome|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
1148106|NCT00440557|O3|Outcome|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
1148107|NCT00440557|O2|Outcome|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
1148108|NCT00440557|O1|Outcome|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
1148109|NCT00440557|O3|Outcome|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
1148110|NCT00440557|O2|Outcome|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
1148111|NCT00440557|O1|Outcome|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
1148112|NCT00440557|O3|Outcome|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
1148113|NCT00440557|O2|Outcome|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
1148114|NCT00440557|O1|Outcome|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
1148115|NCT00440557|E3|Reported Event|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
1148116|NCT00440557|E2|Reported Event|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
1148117|NCT00440557|E1|Reported Event|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
1148118|NCT00440531|B4|Baseline|Total|Total of all reporting groups
1148119|NCT00440531|B3|Baseline|ENGERIX-B™|ENGERIX-B™, 20 µg (micrograms)
1148126|NCT00440531|O2|Outcome|RECOMBIVAX-HB™|RECOMBIVAX-HB™, 10 µg (micrograms)
1148127|NCT00440531|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
1148128|NCT00440531|O3|Outcome|ENGERIX-B™|ENGERIX-B™, 20 µg (micrograms)
1148129|NCT00440531|O2|Outcome|RECOMBIVAX-HB™|RECOMBIVAX-HB™, 10 µg (micrograms)
1148130|NCT00440531|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
1148131|NCT00440531|O3|Outcome|ENGERIX-B™|ENGERIX-B™, 20 µg (micrograms)
1148132|NCT00440531|O2|Outcome|RECOMBIVAX-HB™|RECOMBIVAX-HB™, 10 µg (micrograms)
1148133|NCT00440531|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
1148134|NCT00440531|O1|Outcome|ENGERIX-B™|ENGERIX-B™, 20 µg (micrograms)
1148135|NCT00440531|O2|Outcome|RECOMBIVAX-HB™|RECOMBIVAX-HB™, 10 µg (micrograms)
1148136|NCT00440531|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
1148137|NCT00440518|B4|Baseline|Total|Total of all reporting groups
1148138|NCT00440518|B3|Baseline|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
1148139|NCT00440518|B2|Baseline|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
1148140|NCT00440518|B1|Baseline|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
1148141|NCT00440518|P3|Participant Flow|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
1148142|NCT00440518|P2|Participant Flow|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
1148143|NCT00440518|P1|Participant Flow|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
1148144|NCT00440518|O3|Outcome|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
1148145|NCT00440518|O2|Outcome|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
1148146|NCT00440518|O1|Outcome|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
1148147|NCT00440518|O3|Outcome|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
1148148|NCT00440518|O2|Outcome|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
1148149|NCT00440518|O1|Outcome|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
1148150|NCT00440518|O3|Outcome|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
1148151|NCT00440518|O2|Outcome|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
1148152|NCT00440518|O1|Outcome|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
1148153|NCT00440518|O3|Outcome|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
1148154|NCT00440518|O2|Outcome|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
1148760|NCT00439179|E2|Reported Event|Cohort 2|Cohort 2: Weekly gem + GW572016, 1500 mg/day.
1148155|NCT00440518|O1|Outcome|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
1148156|NCT00440518|O3|Outcome|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
1148157|NCT00440518|O2|Outcome|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
1148158|NCT00440518|O1|Outcome|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
1148159|NCT00440518|E3|Reported Event|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
1148160|NCT00440518|E2|Reported Event|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
1148161|NCT00440518|E1|Reported Event|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
1148162|NCT00440505|B1|Baseline|Entire Study Population|
1148163|NCT00440505|P6|Participant Flow|Nicotine 10 mg First, Then Placebo, Then Nicotine 5 mg|Nicotine 10 mg patch for one day in first intervention period, placebo patch for one day in second intervention period and nicotine 5 mg patch for one day in the third intervention period.
1148164|NCT00440505|P5|Participant Flow|Nicotine 10 mg First, Then Nicotine 5 mg, Then Placebo|Nicotine 10 mg patch for one day in first intervention period, nicotine 5 mg patch for one day in second intervention period and placebo patch for one day in the third intervention period.
1148165|NCT00440505|P4|Participant Flow|Nicotine 5 mg First, Then Placebo, Then Nicotine 10 mg|Nicotine 5 mg patch for one day in first intervention period, placebo patch for one day in second intervention period and nicotine 10 mg patch for one day in the third intervention period.
1148166|NCT00440505|P3|Participant Flow|Nicotine 5 mg First, Then Nicotine 10 mg, Then Placebo|Nicotine 5 mg patch for one day in first intervention period, nicotine 10 mg patch for one day in second intervention period and placebo patch for one day in the third intervention period.
1148167|NCT00440505|P2|Participant Flow|Placebo First, Then Nicotine 10 mg, Then Nicotine 5 mg|Placebo patch for one day in first intervention period, nicotine 10 mg patch for one day in second intervention period and nicotine 5 mg patch for one day in the third intervention period.
1148168|NCT00440505|P1|Participant Flow|Placebo First, Then Nicotine 5 mg, Then Nicotine 10 mg|Placebo patch for one day in first intervention period, nicotine 5 mg patch for one day in second intervention period and nicotine 10 mg patch for one day in the third intervention period.
1148169|NCT00440505|O3|Outcome|Nicotine 10 mg|Nicotine 10 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
1148170|NCT00440505|O2|Outcome|Nicotine 5 mg|Nicotine 5 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
1148171|NCT00440505|O1|Outcome|Placebo|Placebo patch administered for one day in either first intervention period, second intervention period or third intervention period.
1148172|NCT00440505|O3|Outcome|Nicotine 10 mg|Nicotine 10 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
1148173|NCT00440505|O2|Outcome|Nicotine 5 mg|Nicotine 5 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
1148174|NCT00440505|O1|Outcome|Placebo|Placebo patch administered for one day in either first intervention period, second intervention period or third intervention period.
1148175|NCT00440505|O3|Outcome|Nicotine 10 mg|Nicotine 10 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
1148176|NCT00440505|O2|Outcome|Nicotine 5 mg|Nicotine 5 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
1148177|NCT00440505|O1|Outcome|Placebo|Placebo patch administered for one day in either first intervention period, second intervention period or third intervention period.
1148178|NCT00440505|O3|Outcome|Nicotine 10 mg|Nicotine 10 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
1148179|NCT00440505|O2|Outcome|Nicotine 5 mg|Nicotine 5 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
1148180|NCT00440505|O1|Outcome|Placebo|Placebo patch administered for one day in either first intervention period, second intervention period or third intervention period.
1148181|NCT00440505|E3|Reported Event|Nicotine 10mg|Non-smokers with the Nicotine 10mg patch
1148182|NCT00440505|E2|Reported Event|Nicotine 5mg|Non-smokers with the Nicotine 5mg patch
1148183|NCT00440505|E1|Reported Event|Placebo|Non-smokers with the placebo patch
1148184|NCT00440466|B4|Baseline|Total|Total of all reporting groups
1148185|NCT00440466|B3|Baseline|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
1148186|NCT00440466|B2|Baseline|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
1148187|NCT00440466|B1|Baseline|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
1148188|NCT00440466|P3|Participant Flow|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
1148189|NCT00440466|P2|Participant Flow|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
1148190|NCT00440466|P1|Participant Flow|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
1148191|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
1148192|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
1148193|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
1148194|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
1148195|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
1148196|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
1149037|NCT00438399|B4|Baseline|Total|Total of all reporting groups
1148197|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
1148198|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
1148199|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
1148200|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
1148201|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
1148202|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
1148203|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
1148204|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
1148205|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
1148206|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
1148207|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
1148208|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
1148209|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
1148210|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
1148211|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
1148212|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
1148213|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
1148214|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
1148215|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
1148216|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
1148217|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
1148218|NCT00440466|E3|Reported Event|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
1148219|NCT00440466|E2|Reported Event|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
1148220|NCT00440466|E1|Reported Event|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
1148221|NCT00440401|B3|Baseline|Total|Total of all reporting groups
1148224|NCT00440401|P2|Participant Flow|Comparator|Standard haemostatic treatment in cardiovascular surgery
1148225|NCT00440401|P1|Participant Flow|TachoSil®|Absorbable sponge for intra-operative topical application
1148226|NCT00440401|O2|Outcome|Standard Treatment|
1148227|NCT00440401|O1|Outcome|TachoSil®|
1148228|NCT00440401|O2|Outcome|Standard Treatment|
1148229|NCT00440401|O1|Outcome|TachoSil®|
1148230|NCT00440401|E2|Reported Event|Standard Treatment|
1148231|NCT00440401|E1|Reported Event|TachoSil®|
1148232|NCT00440310|B3|Baseline|Total|Total of all reporting groups
1148233|NCT00440310|B2|Baseline|Chemotherapy Alone|"FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin~FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
1148234|NCT00440310|B1|Baseline|Litx + Chemotherapy|"Talaporfin sodium: LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).~Percutaneous placement of device in liver metastases: Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions.~Interstitial light emitting diodes: 200 J/cm per Light Source at 20 mW/cm light energy~FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin~FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
1148235|NCT00440310|P2|Participant Flow|Chemotherapy Alone|"FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin~FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
1148236|NCT00440310|P1|Participant Flow|Litx + Chemotherapy|"Talaporfin sodium: LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).~Percutaneous placement of device in liver metastases: Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions.~Interstitial light emitting diodes: 200 J/cm per Light Source at 20 mW/cm light energy~FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin~FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
1148237|NCT00440310|O2|Outcome|Chemotherapy Alone|"FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin~FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
1148238|NCT00440310|O1|Outcome|Litx + Chemotherapy|"Talaporfin sodium: LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).~Percutaneous placement of device in liver metastases: Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions.~Interstitial light emitting diodes: 200 J/cm per Light Source at 20 mW/cm light energy~FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin~FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
1148239|NCT00440310|E2|Reported Event|Chemotherapy Alone|"FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin~FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
1148761|NCT00439179|E1|Reported Event|Cohort 1|Cohort 1: Weekly gem + GW572016, 1000mg/day.
1148240|NCT00440310|E1|Reported Event|Litx + Chemotherapy|"Talaporfin sodium: LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).~Percutaneous placement of device in liver metastases: Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions.~Interstitial light emitting diodes: 200 J/cm per Light Source at 20 mW/cm light energy~FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin~FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
1148241|NCT00440297|B3|Baseline|Total|Total of all reporting groups
1148242|NCT00440297|B2|Baseline|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
1148243|NCT00440297|B1|Baseline|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
1148244|NCT00440297|P2|Participant Flow|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
1148245|NCT00440297|P1|Participant Flow|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
1148246|NCT00440297|O2|Outcome|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
1148247|NCT00440297|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
1148248|NCT00440297|O2|Outcome|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
1148249|NCT00440297|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
1148250|NCT00440297|O2|Outcome|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
1148251|NCT00440297|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
1148252|NCT00440297|O2|Outcome|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
1148253|NCT00440297|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
1148254|NCT00440297|O2|Outcome|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
1148255|NCT00440297|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
1148256|NCT00440297|E2|Reported Event|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
1148257|NCT00440297|E1|Reported Event|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
1148258|NCT00440271|B3|Baseline|Total|Total of all reporting groups
1148259|NCT00440271|B2|Baseline|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
1148342|NCT00440180|B2|Baseline|Anastrozole|1 milligram daily
1148343|NCT00440180|B1|Baseline|Placebo|Placebo once daily
1148260|NCT00440271|B1|Baseline|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
1148261|NCT00440271|P2|Participant Flow|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
1148262|NCT00440271|P1|Participant Flow|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
1148263|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
1148264|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
1148265|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
1148266|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
1148267|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
1148268|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
1148269|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
1148270|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
1148271|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
1148272|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
1148273|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
1148274|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
1148275|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
1148276|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
1148277|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
1148278|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
1148279|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
1148280|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
1148281|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
1148282|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
1148283|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
1148284|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
1148285|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
1148286|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
1148287|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
1148288|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
1148289|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
1148290|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
1148291|NCT00440271|E2|Reported Event|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
1148292|NCT00440271|E1|Reported Event|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
1148293|NCT00440232|B3|Baseline|Total|Total of all reporting groups
1148294|NCT00440232|B2|Baseline|Placebo|
1148295|NCT00440232|B1|Baseline|Frovatriptan|5.0 mg of Frovatriptan given as single dose
1148296|NCT00440232|P2|Participant Flow|Placebo|
1148297|NCT00440232|P1|Participant Flow|Frovatriptan|5.0 mg of Frovatriptan given as single dose
1148298|NCT00440232|O2|Outcome|Placebo|
1148299|NCT00440232|O1|Outcome|Frovatriptan|5.0 mg of Frovatriptan given as single dose
1148300|NCT00440232|O2|Outcome|Placebo|
1148301|NCT00440232|O1|Outcome|Frovatriptan|5.0 mg of Frovatriptan given as single dose
1148302|NCT00440232|E2|Reported Event|Placebo|
1148303|NCT00440232|E1|Reported Event|Frovatriptan|5.0 mg of Frovatriptan given as single dose
1148304|NCT00440193|B3|Baseline|Total|Total of all reporting groups
1148305|NCT00440193|B2|Baseline|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
1148306|NCT00440193|B1|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
1148307|NCT00440193|P2|Participant Flow|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
1148308|NCT00440193|P1|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
1148309|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
1148310|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
1148344|NCT00440180|P2|Participant Flow|Anastrozole|1 milligram daily
1148345|NCT00440180|P1|Participant Flow|Placebo|Placebo once daily
1148311|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
1148312|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
1148313|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
1148314|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
1148315|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
1148316|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
1148317|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
1148318|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
1148319|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
1148320|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
1148321|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
1148322|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
1148323|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
1148324|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
1148325|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
1148326|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
1148762|NCT00439140|B4|Baseline|Total|Total of all reporting groups
1148327|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
1148328|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
1148329|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
1148330|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
1148331|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
1148332|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
1148333|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
1148334|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
1148335|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
1148336|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
1148337|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
1148338|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
1148339|NCT00440193|E2|Reported Event|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
1148340|NCT00440193|E1|Reported Event|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
1148341|NCT00440180|B3|Baseline|Total|Total of all reporting groups
1148351|NCT00440115|B3|Baseline|Pharmacotherapy Management (Comparison Group)|Health education mailings, free nicotine replacement therapy or bupropion
1148352|NCT00440115|B2|Baseline|Moderate-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions
1148353|NCT00440115|B1|Baseline|High-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions
1148354|NCT00440115|P3|Participant Flow|Pharmacotherapy Management (Comparison Group)|Health education mailings, free nicotine replacement therapy or bupropion
1148355|NCT00440115|P2|Participant Flow|Moderate-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions
1148356|NCT00440115|P1|Participant Flow|High-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions
1148357|NCT00440115|O3|Outcome|Pharmacotherapy Management (Comparison Group)|Health education mailings, free nicotine replacement therapy or bupropion
1148358|NCT00440115|O2|Outcome|Moderate-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions
1148359|NCT00440115|O1|Outcome|High-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions
1148360|NCT00440115|O3|Outcome|Pharmacotherapy Management (Comparison Group)|Health education mailings, free nicotine replacement therapy or bupropion
1148361|NCT00440115|O2|Outcome|Moderate-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions
1148362|NCT00440115|O1|Outcome|High-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions
1148363|NCT00440115|O3|Outcome|Pharmacotherapy Management (Comparison Group)|Health education mailings, free nicotine replacement therapy or bupropion
1148364|NCT00440115|O2|Outcome|Moderate-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions
1148365|NCT00440115|O1|Outcome|High-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions
1148366|NCT00440115|E3|Reported Event|Pharmacotherapy Management (Comparison Group)|Health education mailings, free nicotine replacement therapy or bupropion
1148367|NCT00440115|E2|Reported Event|Moderate-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions
1148368|NCT00440115|E1|Reported Event|High-intensity Disease Management|Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions
1148369|NCT00440050|B3|Baseline|Total|Total of all reporting groups
1148370|NCT00440050|B2|Baseline|Docosahexaenoic Acid (DHA)|Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
1148371|NCT00440050|B1|Baseline|Placebo|Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
1148498|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
1148372|NCT00440050|P2|Participant Flow|Docosahexaenoic Acid (DHA)|Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
1148373|NCT00440050|P1|Participant Flow|Placebo|Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
1148374|NCT00440050|O2|Outcome|Docosahexaenoic Acid (DHA)|Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
1148375|NCT00440050|O1|Outcome|Placebo|Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
1148376|NCT00440050|O2|Outcome|Docosahexaenoic Acid (DHA)|Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
1148377|NCT00440050|O1|Outcome|Placebo|Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
1148378|NCT00440050|O2|Outcome|Docosahexaenoic Acid (DHA)|Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
1148379|NCT00440050|O1|Outcome|Placebo|Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
1148380|NCT00440050|O2|Outcome|Docosahexaenoic Acid (DHA)|Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
1148381|NCT00440050|O1|Outcome|Placebo|Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
1148382|NCT00440050|E2|Reported Event|Docosahexaenoic Acid (DHA)|Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
1148383|NCT00440050|E1|Reported Event|Placebo|Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
1148384|NCT00440011|B3|Baseline|Total|Total of all reporting groups
1148385|NCT00440011|B2|Baseline|Travoprost|travoprost 0.004% 1 drop nightly for 3 months
1148386|NCT00440011|B1|Baseline|Bimatoprost|bimatoprost 0.03% 1 drop nightly for 3 months
1148387|NCT00440011|P2|Participant Flow|Travoprost|travoprost 0.004% 1 drop nightly for 3 months
1148388|NCT00440011|P1|Participant Flow|Bimatoprost|bimatoprost 0.03% 1 drop nightly for 3 months
1148389|NCT00440011|O2|Outcome|Travoprost|travoprost 0.004% 1 drop nightly for 3 months
1148390|NCT00440011|O1|Outcome|Bimatoprost|bimatoprost 0.03% 1 drop nightly for 3 months
1148391|NCT00440011|O2|Outcome|Travoprost|travoprost 0.004% 1 drop nightly for 3 months
1148392|NCT00440011|O1|Outcome|Bimatoprost|bimatoprost 0.03% 1 drop nightly for 3 months
1148393|NCT00440011|E2|Reported Event|Travoprost|travoprost 0.004% 1 drop nightly for 3 months
1148394|NCT00440011|E1|Reported Event|Bimatoprost|bimatoprost 0.03% 1 drop nightly for 3 months
1148395|NCT00439946|B1|Baseline|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
1148425|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
1148426|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
1148396|NCT00439946|P1|Participant Flow|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil initiated to deliver a dose 20% higher than the epoprostenol dose on a ng/kg/min basis. IV treprostinil dosing was titrated without restriction during the eight week follow-up period per the investigator's judgment to optimize the dose for symptomatic benefit based on clinical signs / symptoms, exercise capacity and tolerability.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
1148397|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
1148398|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
1148399|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
1148400|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
1148401|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
1148402|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
1148403|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
1148404|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
1148405|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
1148406|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
1148407|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
1148408|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
1148499|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
1148409|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
1148410|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
1148411|NCT00439946|E1|Reported Event|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
1148412|NCT00439777|B3|Baseline|Total|Total of all reporting groups
1148413|NCT00439777|B2|Baseline|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
1148414|NCT00439777|B1|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
1148415|NCT00439777|P2|Participant Flow|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
1148416|NCT00439777|P1|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
1148417|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
1148418|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
1148419|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
1148420|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
1148421|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
1148422|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
1148423|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
1148424|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
1148427|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
1148428|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
1148429|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
1148430|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
1148431|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
1148432|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
1148433|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
1148434|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
1148435|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
1148436|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
1148437|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
1148438|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
1148439|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
1148440|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
1148441|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
1151084|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
1148442|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
1148443|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
1148444|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
1148445|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
1148446|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
1148447|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
1148448|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
1148449|NCT00439777|E2|Reported Event|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
1148450|NCT00439777|E1|Reported Event|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
1148451|NCT00439738|B3|Baseline|Total|Total of all reporting groups
1148452|NCT00439738|B2|Baseline|HCTZ +Amlodipine|
1148453|NCT00439738|B1|Baseline|Valsartan/HCTZ (Hydrochlorothiazide)|
1148454|NCT00439738|P2|Participant Flow|HCTZ +Amlodipine|
1148455|NCT00439738|P1|Participant Flow|Valsartan/HCTZ (Hydrochlorothiazide)|
1148456|NCT00439738|O2|Outcome|HCTZ +Amlodipine|
1148457|NCT00439738|O1|Outcome|Valsartan/HCTZ (Hydrochlorothiazide)|
1148458|NCT00439738|O2|Outcome|HCTZ +Amlodipine|
1148459|NCT00439738|O1|Outcome|Valsartan/HCTZ (Hydrochlorothiazide)|
1148460|NCT00439738|O2|Outcome|HCTZ +Amlodipine|
1148461|NCT00439738|O1|Outcome|Valsartan/HCTZ (Hydrochlorothiazide)|
1148462|NCT00439738|O2|Outcome|HCTZ +Amlodipine|
1148463|NCT00439738|O1|Outcome|Valsartan/HCTZ (Hydrochlorothiazide)|
1148464|NCT00439738|O2|Outcome|HCTZ +Amlodipine|
1148465|NCT00439738|O1|Outcome|Valsartan/HCTZ (Hydrochlorothiazide)|
1148466|NCT00439738|O2|Outcome|HCTZ +Amlodipine|
1148467|NCT00439738|O1|Outcome|Valsartan/HCTZ (Hydrochlorothiazide)|
1148468|NCT00439738|O2|Outcome|HCTZ +Amlodipine|
1148469|NCT00439738|O1|Outcome|Valsartan/HCTZ (Hydrochlorothiazide)|
1148470|NCT00439725|B3|Baseline|Total|Total of all reporting groups
1156706|NCT00420017|O1|Outcome|Amiodarone|Intravenous amiodarone
1148471|NCT00439725|B2|Baseline|Placebo|Participants were to receive matching placebo oral tablet once daily
1148472|NCT00439725|B1|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
1148473|NCT00439725|P2|Participant Flow|Placebo|Participants were to receive matching placebo oral tablet once daily
1148474|NCT00439725|P1|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
1148475|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
1148476|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
1148477|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
1148478|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
1148479|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
1148480|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
1148481|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
1148482|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
1148483|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
1148484|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
1148485|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
1148486|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
1148487|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
1148488|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
1148489|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
1148490|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
1148491|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
1148492|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
1148493|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
1148494|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
1148495|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
1148496|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
1151465|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
1148500|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
1148501|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
1148502|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
1148503|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
1148504|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
1148505|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
1148506|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
1148507|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
1148508|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
1148509|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
1148510|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
1148511|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
1148512|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
1148513|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
1148514|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
1148515|NCT00439725|E2|Reported Event|Placebo|Participants were to receive matching placebo oral tablet once daily
1148516|NCT00439725|E1|Reported Event|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
1148517|NCT00439647|B3|Baseline|Total|Total of all reporting groups
1148518|NCT00439647|B2|Baseline|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
1148519|NCT00439647|B1|Baseline|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
1148615|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
1150302|NCT00435162|P1|Participant Flow|Low Dose in Both Periods|Valsartan 0.25 mg/kg in both periods
1148520|NCT00439647|P2|Participant Flow|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
1148521|NCT00439647|P1|Participant Flow|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
1148522|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
1148523|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
1148524|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
1148525|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
1148526|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
1148527|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
1148528|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
1148529|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
1148530|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
1148531|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
1148532|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
1148533|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
1148534|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
1148535|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
1148536|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
1148537|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
1148538|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
1148539|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
1148540|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
1148541|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
1148542|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
1148543|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
1148544|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
1148545|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
1148546|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
1148547|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
1148548|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
1148549|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
1148550|NCT00439647|E2|Reported Event|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The i.v. infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year
1148551|NCT00439647|E1|Reported Event|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The i.v. infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year
1148552|NCT00439608|B1|Baseline|Treatment|
1148553|NCT00439608|P1|Participant Flow|Treatment|"Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer~Patients received cetuximab, 400 mg/mg2 over 2 h on Day 1 then 250 mg/m2/week over 1 h, for 5 additional weeks. Patients also received paclitaxel, 50 mg/m2/week, over 1 h and carboplatin AUC (area under the curve) = 2/week, over 30 min, for 6 weeks. Cetuximab was administered first. Patients were then monitored for 1 h. Paclitaxel was then administered followed by carboplatin. Radiation was generally administered after chemotherapy. Dexamethasone 20 mg intravenously (IV), diphenhydramine 50 mg IV, and ranitidine 50 mg IV were given 30 min before treatment. Dosages of dexamethasone and diphenhydramine could be reduced in subsequent weeks if no hypersensitivity reactions were observed."
1148554|NCT00439608|O1|Outcome|Treatment|Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer
1148555|NCT00439608|E1|Reported Event|Treatment|Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer
1148556|NCT00439569|B1|Baseline|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
1148571|NCT00439517|P1|Participant Flow|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
1150303|NCT00435162|O2|Outcome|Placebo|
1148557|NCT00439569|P1|Participant Flow|Subjects Enrolled|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1. Two new subjects were then enrolled in Cohort 2.
1148558|NCT00439569|O1|Outcome|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
1148559|NCT00439569|O1|Outcome|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
1148560|NCT00439569|O1|Outcome|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
1148561|NCT00439569|O1|Outcome|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
1148562|NCT00439569|O1|Outcome|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
1148597|NCT00439413|O2|Outcome|Placebo|Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm placebo patch applied daily for 10 weeks
1151466|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
1148563|NCT00439569|O1|Outcome|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
1148564|NCT00439569|O1|Outcome|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
1148565|NCT00439569|O1|Outcome|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
1148566|NCT00439569|E1|Reported Event|Cohorts 1 & 2 (500 mg/kg/Day)|Cohort 1 was assigned a dosage of 500 mg/kg/day. One subject was replaced due to an allergic reaction and four subjects due to less than 80 percent study drug compliance. Due to these replacements, more than 3 subjects were enrolled in the first cohort. Cohort 2 was assigned a dosage of 500 mg/kg/day by the MCRM and approved by the SMC due to dose-limiting toxicities experienced in Cohort 1. For the purpose of reporting adverse events, these two cohorts were combined for a total of 9 enrolled subjects.
1148567|NCT00439517|B3|Baseline|Total|Total of all reporting groups
1148568|NCT00439517|B2|Baseline|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
1148569|NCT00439517|B1|Baseline|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
1148570|NCT00439517|P2|Participant Flow|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
1148572|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
1148573|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
1148574|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
1148575|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
1148576|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
1148577|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
1148578|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
1148598|NCT00439413|O1|Outcome|Selegiline Transdermal System|Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm patch applied daily for 10 weeks
1148955|NCT00438464|O2|Outcome|Placebo Arm Within GG3|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
1148579|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
1148580|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
1148581|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
1148582|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
1148583|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
1148584|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
1148585|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
1148586|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
1148614|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
1148781|NCT00439140|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1.
1148587|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
1148588|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
1148589|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
1148590|NCT00439517|E2|Reported Event|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
1148591|NCT00439517|E1|Reported Event|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
1148592|NCT00439413|B3|Baseline|Total|Total of all reporting groups
1148593|NCT00439413|B2|Baseline|Placebo|Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm placebo patch applied daily for 10 weeks
1148594|NCT00439413|B1|Baseline|Selegiline Transdermal System|Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm patch applied daily for 10 weeks
1148595|NCT00439413|P2|Participant Flow|Placebo|Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm placebo patch applied daily for 10 weeks
1148596|NCT00439413|P1|Participant Flow|Selegiline Transdermal System|Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm patch applied daily for 10 weeks
1149005|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
1148599|NCT00439413|O2|Outcome|Matching Placebo|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during -2 to -1 week Screening/Baseline Phase.~During treatment, subjects received 20mg x 20cm Selegiline Transdermal System placebo patch, once daily for 10 weeks.~Subjects were provided on-site brief counseling sessions 1x per week for 9 weeks."
1148600|NCT00439413|O1|Outcome|Selegiline Transdermal System|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during -2 to -1 week Screening/Baseline Phase.~During treatment, subjects received 20mg x 20cm Selegiline Transdermal System patch, once daily for 10 weeks.~Subjects were provided on-site brief counseling sessions 1x per week for 9 weeks."
1148601|NCT00439413|E2|Reported Event|Matching Placebo|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during -2 to -1 week Screening/Baseline Phase.~During treatment, subjects received 20mg x 20cm Selegiline Transdermal System placebo patch, once daily for 10 weeks.~Subjects were provided on-site brief counseling sessions 1x per week for 9 weeks."
1148602|NCT00439413|E1|Reported Event|Selegiline Transdermal System|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during -2 to -1 week Screening/Baseline Phase.~During treatment, subjects received 20mg x 20cm Selegiline Transdermal System patch, once daily for 10 weeks.~Subjects were provided on-site brief counseling sessions 1x per week for 9 weeks."
1148603|NCT00439335|B3|Baseline|Total|Total of all reporting groups
1148604|NCT00439335|B2|Baseline|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
1148605|NCT00439335|B1|Baseline|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
1148606|NCT00439335|P2|Participant Flow|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
1148607|NCT00439335|P1|Participant Flow|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
1148608|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
1148609|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
1148610|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
1148611|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
1148612|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
1148613|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
1148878|NCT00438750|O1|Outcome|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
1148616|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
1148617|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
1148618|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
1148619|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
1148620|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
1148621|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
1148622|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
1148623|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
1148624|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
1148625|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
1148626|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
1148627|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
1148628|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
1148629|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
1148630|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
1148631|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
1148632|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
1148633|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
1148634|NCT00439335|E2|Reported Event|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
1148635|NCT00439335|E1|Reported Event|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
1148636|NCT00439309|B3|Baseline|Total|Total of all reporting groups
1148637|NCT00439309|B2|Baseline|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
1148638|NCT00439309|B1|Baseline|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
1148639|NCT00439309|P2|Participant Flow|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
1148640|NCT00439309|P1|Participant Flow|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
1148641|NCT00439309|O2|Outcome|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
1148642|NCT00439309|O1|Outcome|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
1150304|NCT00435162|O1|Outcome|Valsartan|pooled across all dosage levels
1148643|NCT00439309|O2|Outcome|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
1148644|NCT00439309|O1|Outcome|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
1148645|NCT00439309|O2|Outcome|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
1148646|NCT00439309|O1|Outcome|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
1148647|NCT00439309|O2|Outcome|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
1148648|NCT00439309|O1|Outcome|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
1148672|NCT00439270|O2|Outcome|Dasatinib, 50 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
1148905|NCT00438659|P2|Participant Flow|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
1148649|NCT00439309|O2|Outcome|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
1148650|NCT00439309|O1|Outcome|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
1148651|NCT00439309|E2|Reported Event|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
1148652|NCT00439309|E1|Reported Event|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
1148653|NCT00439270|B6|Baseline|Total|Total of all reporting groups
1148654|NCT00439270|B5|Baseline|Dasatinib, 120 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
1148655|NCT00439270|B4|Baseline|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
1148656|NCT00439270|B3|Baseline|Dasatinib, 70 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
1148657|NCT00439270|B2|Baseline|Dasatinib, 50 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
1148658|NCT00439270|B1|Baseline|Dasatinib, 50 mg + Docetaxel, 60 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
1148659|NCT00439270|P5|Participant Flow|Dasatinib, 120 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
1148660|NCT00439270|P4|Participant Flow|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
1148879|NCT00438750|O2|Outcome|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
1148661|NCT00439270|P3|Participant Flow|Dasatinib, 70 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
1148662|NCT00439270|P2|Participant Flow|Dasatinib, 50 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 50 mg administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
1148663|NCT00439270|P1|Participant Flow|Dasatinib, 50 mg + Docetaxel, 60 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2.
1148664|NCT00439270|O5|Outcome|Dasatinib, 120 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
1148665|NCT00439270|O4|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
1148666|NCT00439270|O3|Outcome|Dasatinib, 70 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
1148667|NCT00439270|O2|Outcome|Dasatinib, 50 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
1148668|NCT00439270|O1|Outcome|Dasatinib, 50 mg + Docetaxel, 60 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
1148669|NCT00439270|O5|Outcome|Dasatinib, 120 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
1148670|NCT00439270|O4|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
1148671|NCT00439270|O3|Outcome|Dasatinib, 70 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
1148673|NCT00439270|O1|Outcome|Dasatinib, 50 mg + Docetaxel, 60 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
1148674|NCT00439270|O5|Outcome|Dasatinib, 120 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
1148675|NCT00439270|O4|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
1148676|NCT00439270|O3|Outcome|Dasatinib, 70 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
1148677|NCT00439270|O2|Outcome|Dasatinib, 50 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
1148678|NCT00439270|O1|Outcome|Dasatinib, 50 mg + Docetaxel, 60 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
1148679|NCT00439270|O5|Outcome|Dasatinib, 120 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
1148680|NCT00439270|O4|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
1148681|NCT00439270|O3|Outcome|Dasatinib, 70 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
1148682|NCT00439270|O2|Outcome|Dasatinib, 50 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
1148683|NCT00439270|O1|Outcome|Dasatinib, 50 mg + Docetaxel, 60 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
1148684|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
1148685|NCT00439270|O1|Outcome|All Treated|Participants received dasatinib, 50, 70, 100, or 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 or 75 mg/m^2.
1148686|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2 (Phase 2 )|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
1150305|NCT00435162|O2|Outcome|Placebo|
1148687|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
1148688|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
1148689|NCT00439270|O1|Outcome|All Treated (Phase 1)|Participants received dasatinib as 50, 70, 100, or 120 mg administered orally once daily with docetaxel, administered every 3 weeks as an infusion at 60 or 75 mg/m^2. A standard 3+3 design was used, in which 3-6 patients were exposed to a dose level combination. Using a dose escalation scheme, the first 3-6 patients received the lower dose level combination. Escalation to the next dose level combination for another set of 3-6 patients was initiated if no dose-limiting toxicities (DLTs) were observed. If, for a dose level combination, 2 or more DLTs were observed, the maximum tolerated dose was defined as the previous dose level combination.
1148690|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
1148691|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
1148692|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
1148693|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
1148694|NCT00439270|O1|Outcome|All Treated (Phase 1)|Participants received dasatinib as 50, 70, 100, or 120 mg administered orally once daily with docetaxel, administered every 3 weeks as an infusion at 60 or 75 mg/m^2. A standard 3+3 design was used, in which 3-6 patients were exposed to a dose level combination. Using a dose escalation scheme, the first 3-6 patients received the lower dose level combination. Escalation to the next dose level combination for another set of 3-6 patients was initiated if no dose-limiting toxicities (DLTs) were observed. If 2 or more DLTs were observed for a dose level combination, the MTD was defined as the previous dose level combination.
1148695|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
1148696|NCT00439270|E5|Reported Event|Dasatinib, 70 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
1148697|NCT00439270|E4|Reported Event|Dasatinib, 50 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 50 mg administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
1148698|NCT00439270|E3|Reported Event|Dasatinib, 50 mg + Docetaxel, 60 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2.
1148699|NCT00439270|E2|Reported Event|Dasatinib, 120 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
1148700|NCT00439270|E1|Reported Event|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
1148701|NCT00439244|B4|Baseline|Total|Total of all reporting groups
1148702|NCT00439244|B3|Baseline|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
1148703|NCT00439244|B2|Baseline|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
1148704|NCT00439244|B1|Baseline|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
1148705|NCT00439244|P3|Participant Flow|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
1148706|NCT00439244|P2|Participant Flow|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
1148707|NCT00439244|P1|Participant Flow|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
1148708|NCT00439244|O3|Outcome|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
1148709|NCT00439244|O2|Outcome|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
1148880|NCT00438750|O1|Outcome|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
1148710|NCT00439244|O1|Outcome|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
1148711|NCT00439244|O3|Outcome|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
1148712|NCT00439244|O2|Outcome|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
1148713|NCT00439244|O1|Outcome|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
1148714|NCT00439244|O3|Outcome|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
1148715|NCT00439244|O2|Outcome|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
1148716|NCT00439244|O1|Outcome|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
1148752|NCT00439179|O2|Outcome|Cohort 2|Cohort 2: Weekly gem + GW572016, 1500 mg/day.
1148753|NCT00439179|O1|Outcome|Cohorts 1|Cohort 1: Weekly gem + GW572016, 1000mg/day.
1148754|NCT00439179|O4|Outcome|Cohort 4|GEMOX+ GW572016 1500mg/day
1148755|NCT00439179|O3|Outcome|Cohort 3|GEMOX+ GW572016 1000mg day
1148756|NCT00439179|O2|Outcome|Cohort 2|weekly gem+ GW572016, 1500mg/day
1148717|NCT00439244|O3|Outcome|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
1148718|NCT00439244|O2|Outcome|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
1148719|NCT00439244|O1|Outcome|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
1148720|NCT00439244|O3|Outcome|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
1148721|NCT00439244|O2|Outcome|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
1148722|NCT00439244|O1|Outcome|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
1148723|NCT00439244|E3|Reported Event|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
1148724|NCT00439244|E2|Reported Event|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
1148725|NCT00439244|E1|Reported Event|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
1148726|NCT00439231|B1|Baseline|CLL Subjects Response to Lenalidomide (Revlimid)|To establish a response rate to lenalidomide (Revlimid) in subjects with chronic lymphocytic leukemia (CLL)/ small lymphocytic leukemia (SLL) using a 3 week on, 3 week off dosing regimen. The responses will be categorized using the revised 1996 National Cancer Institute - sponsored working guidelines. The response rate will be based on changes in peripheral blood measures (ANC, platelets and/or hemoglobin), lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; and bone marrow biopsy measured at 24 weeks after the first dose of lenalidomide using the protocol dosing regimen. Complete responders will respond to treatment after 2 cycles. Partial responders will respond to treatment after 4 cycles.
1148881|NCT00438750|O2|Outcome|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
1148727|NCT00439231|P1|Participant Flow|CLL Subjects Response to Lenalidomide (Revlimid)|To establish a response rate to lenalidomide (Revlimid) in subjects with CLL/SLL using a 3 week on, 3 week off dosing regimen. The responses will be categorized using the revised 1996 National Cancer Institute - sponsored working guidelines. The response rate will be based on changes in peripheral blood measures (ANC, platelets and/or hemoglobin), lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; and bone marrow biopsy measured at 24 weeks after the first dose of lenalidomide using the protocol dosing regimen. Complete responders will respond to treatment after 2 cycles. Partial responders will respond to treatment after 4 cycles.
1148728|NCT00439231|O1|Outcome|CLL Subject Response Rate After Lenalidomide Therapy|To establish a response rate to lenalidomide (Revlimid) in subjects with chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) using a 3 week on, 3 week off dosing regimen. Complete responders will respond to treatment after 2 cycles. Partial responders will respond to treatment after 4 cycles.
1148729|NCT00439231|E1|Reported Event|CLL Subjects Treated With Lenalidomide (Revlimid)|
1148730|NCT00439218|B1|Baseline|Subject Enrollments (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
1148731|NCT00439218|P1|Participant Flow|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
1148757|NCT00439179|O1|Outcome|Cohorts 1|Cohort 1: Weekly gem + GW572016, 1000mg/day.
1148758|NCT00439179|E4|Reported Event|Cohort 4|Cohort 4: GEMOX + GW572016 1500 mg/day
1148759|NCT00439179|E3|Reported Event|Cohort 3|Cohort 3: GEMOX + GW572016 1000 mg/day.
1149006|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
1148732|NCT00439218|O1|Outcome|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
1148733|NCT00439218|O1|Outcome|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
1148734|NCT00439218|O1|Outcome|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
1148735|NCT00439218|O1|Outcome|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
1148736|NCT00439218|O1|Outcome|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
1148737|NCT00439218|O1|Outcome|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
1148738|NCT00439218|O1|Outcome|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
1148782|NCT00439140|O2|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
1148783|NCT00439140|O1|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
1148784|NCT00439140|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1.
1148739|NCT00439218|O1|Outcome|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
1148740|NCT00439218|E1|Reported Event|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
1148741|NCT00439179|B5|Baseline|Total|Total of all reporting groups
1148742|NCT00439179|B4|Baseline|Cohort 4|Cohort 4: GEMOX + GW572016 1500 mg/day
1148743|NCT00439179|B3|Baseline|Cohort 3|Cohort 3: GEMOX + GW572016 1000 mg/day.
1148744|NCT00439179|B2|Baseline|Cohort 2|Cohort 2: Weekly gem + GW572016, 1500 mg/day.
1148745|NCT00439179|B1|Baseline|Cohort 1|Cohort 1: Weekly gem + GW572016, 1000mg/day.
1148746|NCT00439179|P4|Participant Flow|Cohort 4|Cohort 4: GEMOX + GW572016 1500 mg/day.(combination)
1148747|NCT00439179|P3|Participant Flow|Cohort 3|Cohort 3: GEMOX + GW572016 1000 mg/day. (combination)
1148748|NCT00439179|P2|Participant Flow|Cohort 2|Cohort 2: Weekly gem + GW572016, 1500 mg/day. (combination)
1148749|NCT00439179|P1|Participant Flow|Cohort 1|Cohort 1: Weekly gem + GW572016, 1000mg/day. (combination)
1148750|NCT00439179|O4|Outcome|Cohort 4|Cohort 4: GEMOX + GW572016 1500 mg/day
1148751|NCT00439179|O3|Outcome|Cohort 3|Cohort 3: GEMOX + GW572016 1000 mg/day.
1148763|NCT00439140|B3|Baseline|Placebo/Botulinum Toxin Type A|Placebo (Normal Saline) injection into the detrusor on Day 1 followed by a botulinum toxin Type A 200U or 300U injection after a minimum of 12 weeks (if applicable).
1148764|NCT00439140|B2|Baseline|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
1148765|NCT00439140|B1|Baseline|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
1148766|NCT00439140|P3|Participant Flow|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1. (If applicable after 12 weeks, participants received either botulinum toxin Type A 200U or 300U in Treatment Cycle 2.)
1148767|NCT00439140|P2|Participant Flow|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
1148768|NCT00439140|P1|Participant Flow|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
1148769|NCT00439140|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1.
1148770|NCT00439140|O2|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
1148771|NCT00439140|O1|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
1148772|NCT00439140|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1.
1148773|NCT00439140|O2|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
1148774|NCT00439140|O1|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
1148775|NCT00439140|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1.
1148776|NCT00439140|O2|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
1148777|NCT00439140|O1|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
1148778|NCT00439140|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1.
1148779|NCT00439140|O2|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
1148780|NCT00439140|O1|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
1148927|NCT00438490|B3|Baseline|Total|Total of all reporting groups
1148785|NCT00439140|O2|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
1148786|NCT00439140|O1|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
1148787|NCT00439140|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1.
1148788|NCT00439140|O2|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
1148789|NCT00439140|O1|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
1148790|NCT00439140|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1.
1148791|NCT00439140|O2|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
1148792|NCT00439140|O1|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
1148793|NCT00439140|E3|Reported Event|Placebo/Botulinum Toxin Type A|Placebo (Normal Saline) injection into the detrusor on Day 1 followed by a botulinum toxin Type A 200U or 300U injection after a minimum of 12 weeks (if applicable).
1148794|NCT00439140|E2|Reported Event|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
1148795|NCT00439140|E1|Reported Event|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
1148796|NCT00438971|B1|Baseline|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
1148797|NCT00438971|P1|Participant Flow|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
1148798|NCT00438971|O1|Outcome|Duloxetine|
1148799|NCT00438971|O1|Outcome|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
1148800|NCT00438971|O1|Outcome|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
1148801|NCT00438971|O1|Outcome|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
1148802|NCT00438971|O1|Outcome|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
1148803|NCT00438971|O1|Outcome|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
1148804|NCT00438971|O1|Outcome|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
1148805|NCT00438971|O1|Outcome|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
1148806|NCT00438971|E1|Reported Event|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
1148807|NCT00438932|B5|Baseline|Total|Total of all reporting groups
1148808|NCT00438932|B4|Baseline|Placebo & Unrestricted Phosphorous Diet|Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
1148809|NCT00438932|B3|Baseline|Placebo & Low Phosphorous Diet|Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.
1148810|NCT00438932|B2|Baseline|Lanthanum Carbonate & Unrestricted Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
1148811|NCT00438932|B1|Baseline|Lanthanum Carbonate & Low Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.
1148812|NCT00438932|P4|Participant Flow|Placebo & Unrestricted Phosphorous Diet|Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
1148813|NCT00438932|P3|Participant Flow|Placebo & Low Phosphorous Diet|Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.
1150306|NCT00435162|O1|Outcome|Valsartan|pooled across all dosage levels
1148814|NCT00438932|P2|Participant Flow|Lanthanum Carbonate & Unrestricted Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
1148815|NCT00438932|P1|Participant Flow|Lanthanum Carbonate & Low Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.
1148816|NCT00438932|O4|Outcome|Placebo & Unrestricted Phosphorous Diet|Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
1148817|NCT00438932|O3|Outcome|Placebo & Low Phosphorous Diet|Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.
1148818|NCT00438932|O2|Outcome|Lanthanum Carbonate & Unrestricted Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
1148819|NCT00438932|O1|Outcome|Lanthanum Carbonate & Low Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.
1148820|NCT00438932|O4|Outcome|Placebo & Unrestricted Phosphorous Diet|Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
1148821|NCT00438932|O3|Outcome|Placebo & Low Phosphorous Diet|Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.
1148822|NCT00438932|O2|Outcome|Lanthanum Carbonate & Unrestricted Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
1148823|NCT00438932|O1|Outcome|Lanthanum Carbonate & Low Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.
1148824|NCT00438932|E4|Reported Event|Placebo & Unrestricted Phosphorous Diet|Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
1148825|NCT00438932|E3|Reported Event|Placebo & Low Phosphorous Diet|Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.
1148826|NCT00438932|E2|Reported Event|Lanthanum Carbonate & Unrestricted Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
1148827|NCT00438932|E1|Reported Event|Lanthanum Carbonate & Low Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.
1148828|NCT00438880|B3|Baseline|Total|Total of all reporting groups
1148829|NCT00438880|B2|Baseline|Phase II|"Phase II patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
1148830|NCT00438880|B1|Baseline|Phase I|"Phase I patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1~10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
1148831|NCT00438880|P2|Participant Flow|Phase II|"Phase II patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
1148832|NCT00438880|P1|Participant Flow|Phase I|"Phase I patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1~10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
1148833|NCT00438880|O2|Outcome|Phase II|"Phase II patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
1148834|NCT00438880|O1|Outcome|Phase I|"Phase I patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1~10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
1148835|NCT00438880|O2|Outcome|Phase II|"Phase II patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
1148836|NCT00438880|O1|Outcome|Phase I|"Phase I patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1~10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
1148837|NCT00438880|O2|Outcome|Phase II|"Phase II patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
1148877|NCT00438750|O2|Outcome|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
1148838|NCT00438880|O1|Outcome|Phase I|"Phase I patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1~10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
1148839|NCT00438880|O2|Outcome|Phase II|"Phase II patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
1148840|NCT00438880|O1|Outcome|Phase I|"Phase I patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1~10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
1148841|NCT00438880|E2|Reported Event|Phase II|"Phase II patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
1148842|NCT00438880|E1|Reported Event|Phase I|"Phase I patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1~10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
1148843|NCT00438854|B1|Baseline|Group 1|
1148844|NCT00438854|P1|Participant Flow|Group 1|
1148845|NCT00438854|O1|Outcome|Dasatinib|Treatment arm/dasatinib pill
1148846|NCT00438854|E1|Reported Event|Group 1|
1148847|NCT00438815|B1|Baseline|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
1148848|NCT00438815|P1|Participant Flow|Open-label C1INH-nf|1,000 Units (U) of C1 esterase inhibitor (C1INH-nf) administered intravenously (IV). If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
1148849|NCT00438815|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
1148850|NCT00438815|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
1148851|NCT00438815|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
1148852|NCT00438815|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
1148853|NCT00438815|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
1148854|NCT00438815|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
1148855|NCT00438815|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
1148856|NCT00438815|E1|Reported Event|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
1148857|NCT00437983|B3|Baseline|Total|Total of all reporting groups
1148858|NCT00437983|B2|Baseline|Placebo|Cellulose tainted with fishy odor
1148859|NCT00437983|B1|Baseline|PS-Omega3|Phosphatidylserine-Omega3, 300mg/day 15 wk
1148860|NCT00437983|P2|Participant Flow|Placebo|Cellulose tainted with fishy odor
1148861|NCT00437983|P1|Participant Flow|PS-Omega3|Phosphatidylserine-Omega3, 300mg/day 15 wk
1148862|NCT00437983|O2|Outcome|Placebo|Cellulose tainted with fishy odor
1148863|NCT00437983|O1|Outcome|PS-Omega3|Phosphatidylserine-Omega3, 300mg/day 15 wk
1148864|NCT00437983|O2|Outcome|Placebo|Cellulose tainted with fishy odor
1148865|NCT00437983|O1|Outcome|PS-Omega3|Phosphatidylserine-Omega3, 300mg/day 15 wk
1148866|NCT00437983|O2|Outcome|Placebo|Cellulose tainted with fishy odor
1148867|NCT00437983|O1|Outcome|PS-Omega3|Phosphatidylserine-Omega3, 300mg/day 15 wk
1148868|NCT00437983|E2|Reported Event|Placebo|Cellulose tainted with fishy odor
1148869|NCT00437983|E1|Reported Event|PS-Omega3|Phosphatidylserine-Omega3, 300mg/day 15 wk
1148870|NCT00438750|B3|Baseline|Total|Total of all reporting groups
1148871|NCT00438750|B2|Baseline|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
1148872|NCT00438750|B1|Baseline|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
1148873|NCT00438750|P2|Participant Flow|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
1148874|NCT00438750|P1|Participant Flow|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
1148875|NCT00438750|O2|Outcome|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
1148876|NCT00438750|O1|Outcome|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
1148882|NCT00438750|O1|Outcome|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
1148883|NCT00438750|O2|Outcome|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
1148884|NCT00438750|O1|Outcome|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
1148885|NCT00438750|O2|Outcome|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
1148886|NCT00438750|O1|Outcome|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
1148887|NCT00438750|O2|Outcome|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
1148888|NCT00438750|O1|Outcome|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
1148889|NCT00438750|E2|Reported Event|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
1148890|NCT00438750|E1|Reported Event|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
1148891|NCT00438672|B3|Baseline|Total|Total of all reporting groups
1148892|NCT00438672|B2|Baseline|Placebo (Lidocaine Only) Cohort|Single injection of 2 mL 1% lidocaine
1148893|NCT00438672|B1|Baseline|Dexamethasone Cohort|Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine
1148894|NCT00438672|P2|Participant Flow|Placebo (Lidocaine Only) Cohort|Single injection of 2 mL 1% lidocaine
1148895|NCT00438672|P1|Participant Flow|Dexamethasone Cohort|Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine
1148896|NCT00438672|O2|Outcome|Placebo (Lidocaine Only) Cohort|Single injection of 2 mL 1% lidocaine
1148897|NCT00438672|O1|Outcome|Dexamethasone Cohort|Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine
1148898|NCT00438672|O2|Outcome|Placebo (Lidocaine Only) Cohort|Single injection of 2 mL 1% lidocaine
1148899|NCT00438672|O1|Outcome|Dexamethasone Cohort|Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine
1148900|NCT00438672|E2|Reported Event|Placebo (Lidocaine Only) Cohort|Single injection of 2 mL 1% lidocaine
1148901|NCT00438672|E1|Reported Event|Dexamethasone Cohort|Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine
1148902|NCT00438659|B3|Baseline|Total|Total of all reporting groups
1148903|NCT00438659|B2|Baseline|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.
1148904|NCT00438659|B1|Baseline|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
1148906|NCT00438659|P1|Participant Flow|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
1148907|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.
1148908|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
1148909|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
1148910|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
1148911|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.
1148912|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
1148913|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.
1148914|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
1148915|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
1148916|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
1148917|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
1148918|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
1148919|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
1148920|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
1148921|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
1148922|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
1148923|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
1148924|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
1148925|NCT00438659|E2|Reported Event|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.
1148926|NCT00438659|E1|Reported Event|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
1148928|NCT00438490|B2|Baseline|Recombinant Human Prolactin|"RhProlactin once daily~Recombinant Human Prolactin :"
1148929|NCT00438490|B1|Baseline|Placebo|
1148930|NCT00438490|P2|Participant Flow|Recombinant Human Prolactin|Recombinant Human Prolactin 60 mcg/kg once daily
1148931|NCT00438490|P1|Participant Flow|Placebo|Normal Saline Placebo once daily
1148932|NCT00438490|O2|Outcome|Recombinant Human Prolactin|"RhProlactin once daily~Recombinant Human Prolactin :"
1148933|NCT00438490|O1|Outcome|Placebo|
1148934|NCT00438490|E2|Reported Event|Recombinant Human Prolactin|"RhProlactin once daily~Recombinant Human Prolactin :"
1148935|NCT00438490|E1|Reported Event|Placebo|
1148936|NCT00438464|B3|Baseline|Total|Total of all reporting groups
1148937|NCT00438464|B2|Baseline|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
1148938|NCT00438464|B1|Baseline|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
1148939|NCT00438464|P2|Participant Flow|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
1148940|NCT00438464|P1|Participant Flow|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
1148941|NCT00438464|O2|Outcome|Within GG4, Placebo Arm|Participants with GG4 score in Plaebo Arm, receiving placebo daily for 4-6 weeks, then receive prostatectomy.
1148942|NCT00438464|O1|Outcome|Within GG3, Placebo Arm|Participants with GG3 score in Placebo Arm, receiving placebo daily for 4-6 weeks, then receive prostatectomy.
1148943|NCT00438464|O2|Outcome|Within GG4, Finasteride Arm|Participants with GG4 score in Finasteride Arm, receiving 5 mg daily for 4-6 weeks, then receive prostatectomy.
1148944|NCT00438464|O1|Outcome|Within GG3, Finasteride Arm|Participants with GG3 score in Finasteride Arm, receiving 5 mg daily for 4-6 weeks, then receive prostatectomy.
1148945|NCT00438464|O2|Outcome|GG4, Within Placebo Arm|Participants with GG4 score in Plaebo Arm, receiving placebo daily for 4-6 weeks, then receive prostatectomy.
1148946|NCT00438464|O1|Outcome|GG3, Within Placebo Arm|Participants with GG3 score in Placebo Arm, receiving placebo daily for 4-6 weeks, then receive prostatectomy.
1148947|NCT00438464|O2|Outcome|GG4, Within Finasteride Arm|Participants with GG4 score receiving 5 mg daily for 4-6 weeks, then receive prostatectomy.
1148948|NCT00438464|O1|Outcome|GG3, Within Finasteride Arm|Participants with GG3 score receiving 5 mg daily for 4-6 weeks, then receive prostatectomy.
1148949|NCT00438464|O2|Outcome|Placebo Arm Within GG4|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
1148950|NCT00438464|O1|Outcome|Finasteride Arm Within GG4|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
1148951|NCT00438464|O2|Outcome|Placebo Arm Within GG3|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
1148952|NCT00438464|O1|Outcome|Finasteride Arm Within GG3|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
1148953|NCT00438464|O2|Outcome|Placebo Arm Within GG4|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
1148954|NCT00438464|O1|Outcome|Finasteride Arm Within GG4|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
1148956|NCT00438464|O1|Outcome|Finasteride Arm Within GG3|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
1148957|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
1148958|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
1148959|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
1148960|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
1148961|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
1148962|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
1148963|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
1148964|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
1148965|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
1148966|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
1148967|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
1148968|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
1148969|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
1148970|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
1148971|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
1148972|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
1148973|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
1148974|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
1148975|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
1148976|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
1148977|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
1148978|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
1148979|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
1148980|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
1148981|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
1148982|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
1156707|NCT00420017|O2|Outcome|Control|Control usual care
1148983|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
1148984|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
1148985|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
1148986|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
1148987|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
1148988|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
1148989|NCT00438464|E2|Reported Event|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
1148990|NCT00438464|E1|Reported Event|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
1148991|NCT00438451|B4|Baseline|Total|Total of all reporting groups
1148992|NCT00438451|B3|Baseline|Lamotrigine|Lamotrigine 25mg
1148993|NCT00438451|B2|Baseline|Carbamazepine|Carbamazepine 100mg
1148994|NCT00438451|B1|Baseline|Levetiracetam|Levetiracetam 250mg
1148995|NCT00438451|P3|Participant Flow|Lamotrigine|Lamotrigine 25mg: capsules, each containing one Lamotrigine 25mg tablet. During titration phase, subjects received 1 capsule in the evening in the first 14 days, 2 capsules (1 in the morning and 1 in the evening) in week 3 and 4, 3 capsules in week 5 (1 in the morning and 2 in the evening) and 4 capsules from week 6 onwards (2 in the morning and 2 in the evening). During maintenance phase, dose adjustments could be made according to tolerability and seizure control in steps of 1 capsule per week. Dosages between 2 to 12 capsules per day were allowed.
1148996|NCT00438451|P2|Participant Flow|Carbamazepine|"Carbamazepine 100mg: capsules, each containing half of one Carbamazepine 200mg slow release tablet.~During titration phase, subjects received 1 capsule in the evening in the first 14 days, 2 capsules (1 in the morning and 1 in the evening) in week 3 and 4, 3 capsules in week 5 (1 in the morning and 2 in the evening) and 4 capsules from week 6 onwards (2 in the morning and 2 in the evening). During maintenance phase, dose adjustments could be made according to tolerability and seizure control in steps of 1 capsule per week. Dosages between 2 to 12 capsules per day were allowed."
1148997|NCT00438451|P1|Participant Flow|Levetiracetam|"Levetiracetam 250mg: capsules, each containing one Levetiracetam 250mg film-coated tablet.~During titration phase, subjects received 1 capsule in the evening in the first 14 days, 2 capsules (1 in the morning and 1 in the evening) in week 3 and 4, 3 capsules in week 5 (1 in the morning and 2 in the evening) and 4 capsules from week 6 onwards (2 in the morning and 2 in the evening). During maintenance phase, dose adjustments could be made according to tolerability and seizure control in steps of 1 capsule per week. Dosages between 2 to 12 capsules per day were allowed."
1148998|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
1148999|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
1149000|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
1149001|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
1149002|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
1149003|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
1149004|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
1149038|NCT00438399|B3|Baseline|C. Propionate Compared to Corticosteroid 3|C. propionate shampoo: once daily Corticosteroid 3 scalp application: twice daily
1149039|NCT00438399|B2|Baseline|C. Propionate Compared to Corticosteroid 2|C. propionate shampoo: once daily Corticosteroid 2 lotion: twice daily
1149040|NCT00438399|B1|Baseline|C. Propionate Compared to Corticosteroid 1|C. propionate shampoo: once daily Corticosteroid 1 foam:twice daily
1149041|NCT00438399|P6|Participant Flow|Corticosteroid 3-Wash Out-C. Propionate|Corticosteroid 3 first, then Clobetasol propionate
1149042|NCT00438399|P5|Participant Flow|C. Propionate -Wash Out-Corticosteroid 3|Clobetasol propionate shampoo first then Corticosteroid 3
1149043|NCT00438399|P4|Participant Flow|Corticosteroid 2-Wash Out-C. Propionate|Corticosteroid 2 first, then Clobetasol propionate shampoo
1149044|NCT00438399|P3|Participant Flow|C. Propionate-Wash Out-Corticosteroid 2|Clobetasol propionate Shampoo first, then Corticosteroid 2
1149045|NCT00438399|P2|Participant Flow|Corticosteroid 1-Wash Out-C. Propionate|Corticosteroid 1 first then Clobetasol propionate Shampoo
1149046|NCT00438399|P1|Participant Flow|C. Propionate-Wash Out-Corticosteroid 1|Clobetasol propionate Shampoo first, then Corticosteroid 1
1149047|NCT00438399|O3|Outcome|C. Propionate Compared to Corticosteroid 3|C. propionate shampoo: once daily Corticosteroid 3 scalp application: twice daily
1149048|NCT00438399|O2|Outcome|C. Propionate Compared to Corticosteroid 2|C. propionate shampoo: once daily Corticosteroid 2 lotion: twice daily
1149049|NCT00438399|O1|Outcome|C. Propionate Compared to Corticosteroid 1|C. propionate shampoo: once daily Corticosteroid 1 foam:twice daily
1149050|NCT00438399|E4|Reported Event|Clobetasol Propionate Shampoo|All subjects having used Clobetasol propionate shampoo
1149051|NCT00438399|E3|Reported Event|Corticosteroid 3|All subjects having used Corticosteroid 3
1149052|NCT00438399|E2|Reported Event|Corticosteroid 2|All subjects having used Corticosteroid 2
1149053|NCT00438399|E1|Reported Event|Corticosteroid 1|All subjects having used Corticosteroid 1
1149054|NCT00438360|B3|Baseline|Total|Total of all reporting groups
1149055|NCT00438360|B2|Baseline|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
1149056|NCT00438360|B1|Baseline|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
1149057|NCT00438360|P2|Participant Flow|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
1149058|NCT00438360|P1|Participant Flow|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
1149059|NCT00438360|O2|Outcome|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
1149060|NCT00438360|O1|Outcome|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
1149061|NCT00438360|O2|Outcome|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
1149062|NCT00438360|O1|Outcome|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
1149063|NCT00438360|O2|Outcome|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
1149064|NCT00438360|O1|Outcome|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
1149065|NCT00438360|O2|Outcome|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
1149066|NCT00438360|O1|Outcome|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
1149067|NCT00438360|O2|Outcome|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
1149068|NCT00438360|O1|Outcome|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
1149069|NCT00438360|E2|Reported Event|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
1149070|NCT00438360|E1|Reported Event|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
1149071|NCT00438204|B1|Baseline|Bevacizumab, Gemcitabine Hydrochloride|"Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days~Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.~bevacizumab: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~gemcitabine hydrochloride: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days~pemetrexed disodium: Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days."
1149072|NCT00438204|P1|Participant Flow|Bevacizumab, Gemcitabine Hydrochloride|"Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days~Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.~bevacizumab: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~gemcitabine hydrochloride: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days~pemetrexed disodium: Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days."
1149073|NCT00438204|O1|Outcome|Bevacizumab, Gemcitabine Hydrochloride|"Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days~Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.~bevacizumab: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~gemcitabine hydrochloride: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days~pemetrexed disodium: Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days."
1151467|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
1149074|NCT00438204|E1|Reported Event|Bevacizumab, Gemcitabine Hydrochloride|"Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days~Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.~bevacizumab: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~gemcitabine hydrochloride: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days~pemetrexed disodium: Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days."
1149075|NCT00438100|B3|Baseline|Total|Total of all reporting groups
1149076|NCT00438100|B2|Baseline|S-1 Arm|"S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course.~S-1: 80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course."
1150307|NCT00435162|O3|Outcome|High Dose|Extemporaneous suspension of valsartan 4.0 mg/kg, taken once daily
1149077|NCT00438100|B1|Baseline|Capecitabine Arm|"Capecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.~Capecitabine: 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course."
1149078|NCT00438100|P2|Participant Flow|S-1 Arm|"S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course.~S-1: 80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course."
1149079|NCT00438100|P1|Participant Flow|Capecitabine Arm|"Capecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.~Capecitabine: 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course."
1149080|NCT00438100|O2|Outcome|S-1 Arm|"S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course.~S-1: 80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course."
1149081|NCT00438100|O1|Outcome|Capecitabine Arm|"Capecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.~Capecitabine: 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course."
1149082|NCT00438100|E2|Reported Event|S-1 Arm|"S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course.~S-1: 80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course."
1149083|NCT00438100|E1|Reported Event|Capecitabine Arm|"Capecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.~Capecitabine: 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course."
1149084|NCT00437645|B3|Baseline|Total|Total of all reporting groups
1149085|NCT00437645|B2|Baseline|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
1149086|NCT00437645|B1|Baseline|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
1149087|NCT00437645|P2|Participant Flow|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
1149088|NCT00437645|P1|Participant Flow|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
1149089|NCT00437645|O2|Outcome|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
1149090|NCT00437645|O1|Outcome|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
1149106|NCT00437489|O2|Outcome|Exubera Dose (mg) as Per Weight Based Formula TID|Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
1149107|NCT00437489|O1|Outcome|Exubera Dose of 1mg Three Times Daily (TID)|Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
1149108|NCT00437489|O2|Outcome|Exubera Dose (mg) as Per Weight Based Formula TID|Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
1149091|NCT00437645|O2|Outcome|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
1149092|NCT00437645|O1|Outcome|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
1149114|NCT00437489|E2|Reported Event|Exubera Dose (mg) as Per Weight Based Formula TID|Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
1149115|NCT00437489|E1|Reported Event|Exubera Dose of 1mg Three Times Daily (TID)|Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
1149093|NCT00437645|O2|Outcome|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
1149094|NCT00437645|O1|Outcome|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
1149095|NCT00437645|O2|Outcome|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
1149096|NCT00437645|O1|Outcome|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
1149097|NCT00437645|O2|Outcome|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
1149098|NCT00437645|O1|Outcome|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
1149099|NCT00437645|E2|Reported Event|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
1149100|NCT00437645|E1|Reported Event|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
1149101|NCT00437489|B3|Baseline|Total|Total of all reporting groups
1149102|NCT00437489|B2|Baseline|Exubera Dose (mg) as Per Weight Based Formula TID|Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
1149103|NCT00437489|B1|Baseline|Exubera Dose of 1mg Three Times Daily (TID)|Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
1149104|NCT00437489|P2|Participant Flow|Exubera Dose (mg) as Per Weight Based Formula TID|Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
1149105|NCT00437489|P1|Participant Flow|Exubera Dose of 1mg Three Times Daily (TID)|Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
1149109|NCT00437489|O1|Outcome|Exubera Dose of 1mg Three Times Daily (TID)|Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
1149110|NCT00437489|O2|Outcome|Exubera Dose (mg) as Per Weight Based Formula TID|Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
1149111|NCT00437489|O1|Outcome|Exubera Dose of 1mg Three Times Daily (TID)|Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
1149112|NCT00437489|O2|Outcome|Exubera Dose (mg) as Per Weight Based Formula TID|Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
1149113|NCT00437489|O1|Outcome|Exubera Dose of 1mg Three Times Daily (TID)|Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
1149116|NCT00437398|B1|Baseline|Islet Transplant|Subjects will receive standard intraportal transplantation or portal venous system infusion via laparotomy of purified pancreatic islets.
1149117|NCT00437398|P1|Participant Flow|Islet Transplant|Subjects will receive standard intraportal transplantation or portal venous system infusion via laparotomy of purified pancreatic islets.
1149118|NCT00437398|O1|Outcome|Islet Transplant|Subjects will receive standard intraportal transplantation or portal venous system infusion via laparotomy of purified pancreatic islets.
1149119|NCT00437398|O1|Outcome|Islet Transplant|Subjects will receive standard intraportal transplantation or portal venous system infusion via laparotomy of purified pancreatic islets.
1149120|NCT00437398|E1|Reported Event|Islet Transplant|Subjects will receive standard intraportal transplantation or portal venous system infusion via laparotomy of purified pancreatic islets.
1149121|NCT00437281|B21|Baseline|Total|Total of all reporting groups
1149122|NCT00437281|B20|Baseline|Placebo (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149123|NCT00437281|B19|Baseline|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149124|NCT00437281|B18|Baseline|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149125|NCT00437281|B17|Baseline|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149126|NCT00437281|B16|Baseline|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149127|NCT00437281|B15|Baseline|Placebo (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149128|NCT00437281|B14|Baseline|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149129|NCT00437281|B13|Baseline|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149130|NCT00437281|B12|Baseline|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149131|NCT00437281|B11|Baseline|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149132|NCT00437281|B10|Baseline|Placebo (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149472|NCT00437203|P3|Participant Flow|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149133|NCT00437281|B9|Baseline|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149134|NCT00437281|B8|Baseline|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149135|NCT00437281|B7|Baseline|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149136|NCT00437281|B6|Baseline|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149137|NCT00437281|B5|Baseline|Placebo (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149138|NCT00437281|B4|Baseline|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149139|NCT00437281|B3|Baseline|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149140|NCT00437281|B2|Baseline|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149141|NCT00437281|B1|Baseline|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149142|NCT00437281|P20|Participant Flow|Placebo (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149143|NCT00437281|P19|Participant Flow|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149144|NCT00437281|P18|Participant Flow|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149145|NCT00437281|P17|Participant Flow|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149146|NCT00437281|P16|Participant Flow|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149147|NCT00437281|P15|Participant Flow|Placebo (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149148|NCT00437281|P14|Participant Flow|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1151468|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
1149149|NCT00437281|P13|Participant Flow|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149150|NCT00437281|P12|Participant Flow|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149151|NCT00437281|P11|Participant Flow|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1156708|NCT00420017|O1|Outcome|Amiodarone|Intravenous amiodarone
1149152|NCT00437281|P10|Participant Flow|Placebo (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149153|NCT00437281|P9|Participant Flow|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149154|NCT00437281|P8|Participant Flow|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149155|NCT00437281|P7|Participant Flow|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149156|NCT00437281|P6|Participant Flow|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149157|NCT00437281|P5|Participant Flow|Placebo (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149158|NCT00437281|P4|Participant Flow|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149159|NCT00437281|P3|Participant Flow|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149160|NCT00437281|P2|Participant Flow|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149161|NCT00437281|P1|Participant Flow|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149162|NCT00437281|O20|Outcome|Placebo (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149163|NCT00437281|O19|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149164|NCT00437281|O18|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149165|NCT00437281|O17|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149166|NCT00437281|O16|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149167|NCT00437281|O15|Outcome|Placebo (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1156709|NCT00420017|O2|Outcome|Control|Control usual care
1149168|NCT00437281|O14|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149169|NCT00437281|O13|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149170|NCT00437281|O12|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149171|NCT00437281|O11|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149172|NCT00437281|O10|Outcome|Placebo (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149173|NCT00437281|O9|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149174|NCT00437281|O8|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149175|NCT00437281|O7|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149176|NCT00437281|O6|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149177|NCT00437281|O5|Outcome|Placebo (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149178|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149179|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149180|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149645|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
1149181|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149182|NCT00437281|O16|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149183|NCT00437281|O15|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149627|NCT00437034|B1|Baseline|Treatment (Antiangiogenesis Therapy)|"Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~aflibercept: Given IV"
1149184|NCT00437281|O14|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149185|NCT00437281|O13|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149186|NCT00437281|O12|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149187|NCT00437281|O11|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149188|NCT00437281|O10|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149189|NCT00437281|O9|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149190|NCT00437281|O8|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149191|NCT00437281|O7|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149192|NCT00437281|O6|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149193|NCT00437281|O5|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149194|NCT00437281|O4|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149195|NCT00437281|O3|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149196|NCT00437281|O2|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149646|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
1149197|NCT00437281|O1|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149198|NCT00437281|O16|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149199|NCT00437281|O15|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149200|NCT00437281|O14|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149201|NCT00437281|O13|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149202|NCT00437281|O12|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149203|NCT00437281|O11|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149204|NCT00437281|O10|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149205|NCT00437281|O9|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149206|NCT00437281|O8|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149207|NCT00437281|O7|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149208|NCT00437281|O6|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149209|NCT00437281|O5|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149210|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149211|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149212|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149647|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
1149648|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
1149213|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149214|NCT00437281|O16|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149215|NCT00437281|O15|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149216|NCT00437281|O14|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149482|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149217|NCT00437281|O13|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149218|NCT00437281|O12|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149219|NCT00437281|O11|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149220|NCT00437281|O10|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149221|NCT00437281|O9|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149222|NCT00437281|O8|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149223|NCT00437281|O7|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149224|NCT00437281|O6|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149225|NCT00437281|O5|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149226|NCT00437281|O4|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149227|NCT00437281|O3|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149228|NCT00437281|O2|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149649|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
1149229|NCT00437281|O1|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149230|NCT00437281|O16|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149231|NCT00437281|O15|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149232|NCT00437281|O14|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149233|NCT00437281|O13|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149234|NCT00437281|O12|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149235|NCT00437281|O11|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149236|NCT00437281|O10|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149237|NCT00437281|O9|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149238|NCT00437281|O8|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149239|NCT00437281|O7|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149240|NCT00437281|O6|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149241|NCT00437281|O5|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149242|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149243|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149244|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149650|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
1149651|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
1149245|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149246|NCT00437281|O16|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149247|NCT00437281|O15|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149248|NCT00437281|O14|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149249|NCT00437281|O13|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149502|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149250|NCT00437281|O12|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149251|NCT00437281|O11|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149252|NCT00437281|O10|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149253|NCT00437281|O9|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149254|NCT00437281|O8|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149255|NCT00437281|O7|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149256|NCT00437281|O6|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149257|NCT00437281|O5|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149258|NCT00437281|O4|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149259|NCT00437281|O3|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149260|NCT00437281|O2|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149652|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
1149261|NCT00437281|O1|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149262|NCT00437281|O16|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149263|NCT00437281|O15|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149264|NCT00437281|O14|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149265|NCT00437281|O13|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149266|NCT00437281|O12|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149267|NCT00437281|O11|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149268|NCT00437281|O10|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149269|NCT00437281|O9|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149270|NCT00437281|O8|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149271|NCT00437281|O7|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149272|NCT00437281|O6|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149273|NCT00437281|O5|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149274|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149275|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149276|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149653|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
1149654|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
1149277|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149278|NCT00437281|O16|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149279|NCT00437281|O15|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149280|NCT00437281|O14|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149281|NCT00437281|O13|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149282|NCT00437281|O12|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149522|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149283|NCT00437281|O11|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149284|NCT00437281|O10|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149285|NCT00437281|O9|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149286|NCT00437281|O8|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149287|NCT00437281|O7|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149288|NCT00437281|O6|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149289|NCT00437281|O5|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149290|NCT00437281|O4|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149291|NCT00437281|O3|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149292|NCT00437281|O2|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149655|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
1149293|NCT00437281|O1|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149294|NCT00437281|O16|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149295|NCT00437281|O15|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149296|NCT00437281|O14|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149297|NCT00437281|O13|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149298|NCT00437281|O12|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149299|NCT00437281|O11|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149300|NCT00437281|O10|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149301|NCT00437281|O9|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149302|NCT00437281|O8|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149303|NCT00437281|O7|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149304|NCT00437281|O6|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149305|NCT00437281|O5|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149306|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149307|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149308|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149656|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
1149657|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
1149309|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149310|NCT00437281|O16|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149311|NCT00437281|O15|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149312|NCT00437281|O14|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149313|NCT00437281|O13|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149314|NCT00437281|O12|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149315|NCT00437281|O11|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149542|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149316|NCT00437281|O10|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149317|NCT00437281|O9|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149318|NCT00437281|O8|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149319|NCT00437281|O7|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149320|NCT00437281|O6|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149321|NCT00437281|O5|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149322|NCT00437281|O4|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149323|NCT00437281|O3|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149324|NCT00437281|O2|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149658|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
1149325|NCT00437281|O1|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149326|NCT00437281|O16|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149327|NCT00437281|O15|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149328|NCT00437281|O14|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149329|NCT00437281|O13|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149330|NCT00437281|O12|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149331|NCT00437281|O11|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149332|NCT00437281|O10|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149333|NCT00437281|O9|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149334|NCT00437281|O8|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149335|NCT00437281|O7|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149336|NCT00437281|O6|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149337|NCT00437281|O5|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149338|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149339|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149340|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149659|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
1149660|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
1149341|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149342|NCT00437281|O16|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149343|NCT00437281|O15|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149344|NCT00437281|O14|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149345|NCT00437281|O13|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149346|NCT00437281|O12|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149347|NCT00437281|O11|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149348|NCT00437281|O10|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149562|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149349|NCT00437281|O9|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149350|NCT00437281|O8|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149351|NCT00437281|O7|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149352|NCT00437281|O6|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149353|NCT00437281|O5|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149354|NCT00437281|O4|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149355|NCT00437281|O3|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149356|NCT00437281|O2|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149661|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
1149357|NCT00437281|O1|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149358|NCT00437281|O16|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149359|NCT00437281|O15|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149360|NCT00437281|O14|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149361|NCT00437281|O13|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149362|NCT00437281|O12|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149363|NCT00437281|O11|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149364|NCT00437281|O10|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149586|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
1149587|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
1149365|NCT00437281|O9|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149366|NCT00437281|O8|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149367|NCT00437281|O7|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149368|NCT00437281|O6|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149369|NCT00437281|O5|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149370|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149371|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149471|NCT00437203|P4|Participant Flow|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149372|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149373|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149374|NCT00437281|O20|Outcome|Placebo (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149375|NCT00437281|O19|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149376|NCT00437281|O18|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149377|NCT00437281|O17|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149378|NCT00437281|O16|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149379|NCT00437281|O15|Outcome|Placebo (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149380|NCT00437281|O14|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149588|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
1149381|NCT00437281|O13|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149382|NCT00437281|O12|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149383|NCT00437281|O11|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149384|NCT00437281|O10|Outcome|Placebo (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149385|NCT00437281|O9|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149386|NCT00437281|O8|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149387|NCT00437281|O7|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149388|NCT00437281|O6|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149389|NCT00437281|O5|Outcome|Placebo (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149390|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149391|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149392|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149393|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149394|NCT00437281|O20|Outcome|Placebo (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149395|NCT00437281|O19|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149396|NCT00437281|O18|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149589|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
1149397|NCT00437281|O17|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149398|NCT00437281|O16|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149399|NCT00437281|O15|Outcome|Placebo (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149400|NCT00437281|O14|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149401|NCT00437281|O13|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149402|NCT00437281|O12|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149403|NCT00437281|O11|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149404|NCT00437281|O10|Outcome|Placebo (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149405|NCT00437281|O9|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149406|NCT00437281|O8|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149407|NCT00437281|O7|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149408|NCT00437281|O6|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149409|NCT00437281|O5|Outcome|Placebo (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149410|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149411|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149412|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149590|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
1149413|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149414|NCT00437281|O20|Outcome|Placebo (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149415|NCT00437281|O19|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149416|NCT00437281|O18|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149417|NCT00437281|O17|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149418|NCT00437281|O16|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149435|NCT00437281|E19|Reported Event|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149419|NCT00437281|O15|Outcome|Placebo (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149420|NCT00437281|O14|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149421|NCT00437281|O13|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149422|NCT00437281|O12|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149423|NCT00437281|O11|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149424|NCT00437281|O10|Outcome|Placebo (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149425|NCT00437281|O9|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149426|NCT00437281|O8|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149427|NCT00437281|O7|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149428|NCT00437281|O6|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149591|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
1149429|NCT00437281|O5|Outcome|Placebo (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149430|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149431|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149432|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149433|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149434|NCT00437281|E20|Reported Event|Placebo (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149436|NCT00437281|E18|Reported Event|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149437|NCT00437281|E17|Reported Event|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149438|NCT00437281|E16|Reported Event|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149439|NCT00437281|E15|Reported Event|Placebo (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149440|NCT00437281|E14|Reported Event|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149441|NCT00437281|E13|Reported Event|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149442|NCT00437281|E12|Reported Event|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149443|NCT00437281|E11|Reported Event|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149444|NCT00437281|E10|Reported Event|Placebo (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1150151|NCT00435591|O4|Outcome|Dose Regimen 4|Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
1149445|NCT00437281|E9|Reported Event|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149446|NCT00437281|E8|Reported Event|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149447|NCT00437281|E7|Reported Event|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149448|NCT00437281|E6|Reported Event|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149449|NCT00437281|E5|Reported Event|Placebo (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149450|NCT00437281|E4|Reported Event|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149451|NCT00437281|E3|Reported Event|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149452|NCT00437281|E2|Reported Event|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149453|NCT00437281|E1|Reported Event|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
1149454|NCT00437203|B11|Baseline|Total|Total of all reporting groups
1149455|NCT00437203|B10|Baseline|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
1149456|NCT00437203|B9|Baseline|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
1149457|NCT00437203|B8|Baseline|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149458|NCT00437203|B7|Baseline|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149459|NCT00437203|B6|Baseline|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149460|NCT00437203|B5|Baseline|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149461|NCT00437203|B4|Baseline|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149462|NCT00437203|B3|Baseline|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149592|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
1149593|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
1149463|NCT00437203|B2|Baseline|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149464|NCT00437203|B1|Baseline|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149465|NCT00437203|P10|Participant Flow|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
1149466|NCT00437203|P9|Participant Flow|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
1149467|NCT00437203|P8|Participant Flow|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149468|NCT00437203|P7|Participant Flow|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149469|NCT00437203|P6|Participant Flow|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149470|NCT00437203|P5|Participant Flow|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149473|NCT00437203|P2|Participant Flow|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149474|NCT00437203|P1|Participant Flow|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 milligram (mg) 3 hours (hrs) infusion intravenously (IV) on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg per square meter (mg/m^2) 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149475|NCT00437203|O10|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
1149476|NCT00437203|O9|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
1149477|NCT00437203|O8|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149478|NCT00437203|O7|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149479|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149480|NCT00437203|O5|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149481|NCT00437203|O4|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1156710|NCT00420017|O1|Outcome|Amiodarone|Intravenous amiodarone
1149483|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149484|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149485|NCT00437203|O10|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
1149486|NCT00437203|O9|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
1149487|NCT00437203|O8|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149488|NCT00437203|O7|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149489|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149490|NCT00437203|O5|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149491|NCT00437203|O4|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149492|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149493|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149494|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149495|NCT00437203|O10|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
1149496|NCT00437203|O9|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
1149497|NCT00437203|O8|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149498|NCT00437203|O7|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149499|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149500|NCT00437203|O5|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149501|NCT00437203|O4|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149594|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
1149503|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149504|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149505|NCT00437203|O10|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
1149506|NCT00437203|O9|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
1149507|NCT00437203|O8|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149508|NCT00437203|O7|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149509|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149510|NCT00437203|O5|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149511|NCT00437203|O4|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149512|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149513|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149514|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149515|NCT00437203|O7|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
1149516|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
1149517|NCT00437203|O5|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149518|NCT00437203|O4|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149519|NCT00437203|O3|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149520|NCT00437203|O2|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149521|NCT00437203|O1|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149595|NCT00437125|E1|Reported Event|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
1149523|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149524|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149525|NCT00437203|O10|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
1149526|NCT00437203|O9|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
1149527|NCT00437203|O8|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149528|NCT00437203|O7|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149529|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149530|NCT00437203|O5|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149531|NCT00437203|O4|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149532|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149533|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149534|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149535|NCT00437203|O10|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
1149536|NCT00437203|O9|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
1149537|NCT00437203|O8|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149538|NCT00437203|O7|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149539|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149540|NCT00437203|O5|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149541|NCT00437203|O4|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149596|NCT00437073|B3|Baseline|Total|Total of all reporting groups
1150152|NCT00435591|O3|Outcome|Dose Regimen 3|Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
1149543|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149544|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149545|NCT00437203|O10|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
1149546|NCT00437203|O9|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
1149547|NCT00437203|O8|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149548|NCT00437203|O7|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149549|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149550|NCT00437203|O5|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149551|NCT00437203|O4|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149552|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149553|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149554|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149555|NCT00437203|O10|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
1149556|NCT00437203|O9|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
1149557|NCT00437203|O8|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149558|NCT00437203|O7|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149559|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149560|NCT00437203|O5|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149561|NCT00437203|O4|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149672|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
1149563|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149564|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149565|NCT00437203|O2|Outcome|PF-00477736 + Gemcitabine 1000 mg/m^2|PF-00477736 infusion 180 mg or 225 mg IV administered over 24 hrs on Days 2 and 9 of each cycle (21 days cycle) along with gemcitabine infusion 1000 mg/m^2 IV administered over 30 minutes on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149566|NCT00437203|O1|Outcome|PF-00477736 + Gemcitabine 750 mg/m^2|PF-00477736 infusion 50 mg, 65 mg or 80 mg IV administered over 3 hrs on Days 1 and 8 of Cycle 0 (21 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle), or PF-00477736 infusion 80 mg, 120 mg, 180 mg, 270 mg or 340 mg IV administered over 24 hrs on Days 1 and 8 of Cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 750 mg/m^2 IV administered over 30 minutes on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149567|NCT00437203|E10|Reported Event|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
1149568|NCT00437203|E9|Reported Event|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
1149569|NCT00437203|E8|Reported Event|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149570|NCT00437203|E7|Reported Event|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149571|NCT00437203|E6|Reported Event|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149662|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
1149572|NCT00437203|E5|Reported Event|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149573|NCT00437203|E4|Reported Event|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149574|NCT00437203|E3|Reported Event|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149575|NCT00437203|E2|Reported Event|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149576|NCT00437203|E1|Reported Event|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
1149577|NCT00437125|B1|Baseline|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
1149578|NCT00437125|P1|Participant Flow|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
1149579|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
1149580|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
1149581|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
1149582|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
1149583|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
1149584|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
1149585|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
1149597|NCT00437073|B2|Baseline|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
1149598|NCT00437073|B1|Baseline|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
1149599|NCT00437073|P2|Participant Flow|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
1149600|NCT00437073|P1|Participant Flow|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
1149601|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
1149602|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
1149603|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
1149663|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
1150196|NCT00435539|E2|Reported Event|Ocriplasmin 125µg Single Injection|Ocriplasmin 125µg single injection versus sham injection
1149604|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
1149605|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
1149606|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
1149607|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
1149608|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
1149609|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
1149610|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
1149611|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
1149673|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
1149612|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
1149613|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
1149614|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
1149615|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
1149616|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
1149617|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
1149664|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
1149665|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
1151469|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
1149618|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
1149619|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
1149620|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
1149621|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
1149622|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
1149623|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
1149624|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
1149625|NCT00437073|E2|Reported Event|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
1149626|NCT00437073|E1|Reported Event|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
1149628|NCT00437034|P1|Participant Flow|Treatment (Antiangiogenesis Therapy)|"Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~aflibercept: Given IV"
1149629|NCT00437034|O1|Outcome|Treatment (Antiangiogenesis Therapy)|"Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~aflibercept: Given IV"
1149630|NCT00437034|E1|Reported Event|Treatment (Antiangiogenesis Therapy)|"Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~aflibercept: Given IV"
1149631|NCT00436982|B3|Baseline|Total|Total of all reporting groups
1149632|NCT00436982|B2|Baseline|Duracon|30 patients randomized into the Duracon arm
1149633|NCT00436982|B1|Baseline|Triathlon|30 patients randomized into the Triathlon arm
1149634|NCT00436982|P2|Participant Flow|Duracon Total Knee System|"30 patients were randomized into the Duracon total knee system arm. The Duracon total knee system is the predecessor of the Triathlon total knee system and was observed in a prospective randomised, parallel, double-blind study.~Duracon total knee system: Orthopaedic implant"
1149635|NCT00436982|P1|Participant Flow|Cemented Triathlon Total Knee System|"30 patients were randomized into the Triathlon total knee system arm. TheTriathlon total knee system is the successor of the Duracon total knee system and was observed in a prospective randomised, parallel, double-blind study.~Cemented Triathlon total knee system: Orthopaedic implant"
1149636|NCT00436982|O2|Outcome|Duracon|30 patients randomized into the Duracon arm
1149637|NCT00436982|O1|Outcome|Triathlon|30 patients randomized into the Triathlon arm
1149638|NCT00436982|E2|Reported Event|Duracon|30 patients randomized into the Duracon arm
1149639|NCT00436982|E1|Reported Event|Triathlon|30 patients randomized into the Triathlon arm
1149640|NCT00436969|B3|Baseline|Total|Total of all reporting groups
1149641|NCT00436969|B2|Baseline|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
1149642|NCT00436969|B1|Baseline|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
1149643|NCT00436969|P2|Participant Flow|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
1149644|NCT00436969|P1|Participant Flow|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
1149666|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
1149667|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
1149668|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
1149669|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
1149670|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
1149671|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
1150153|NCT00435591|O2|Outcome|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
1149674|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
1149675|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
1149676|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
1149677|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
1149678|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
1149679|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
1149680|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
1149681|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
1149682|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
1149683|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
1149684|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
1149685|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
1149686|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
1149687|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
1149688|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
1149689|NCT00436969|E2|Reported Event|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
1149690|NCT00436969|E1|Reported Event|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine)and 2 mL of corticosteroid (Celestone).
1149691|NCT00436956|B1|Baseline|All Participants - AZD2171 & Prednisone|This group combines participants who received 20 mg AZD2171 (Cediranib) orally daily (n=35), in addition to participants who received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone (n=23). One pt was not evaluable due to a cord compression on day 2 of therapy; was removed from the trial (n=1).
1149692|NCT00436956|P2|Participant Flow|20 mg AZD2171 + 10mg Prednisone Daily|Participants received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone.
1149693|NCT00436956|P1|Participant Flow|20 mg AZD2171 Daily|Participants received 20 mg AZD2171 (Cediranib) orally daily.
1149694|NCT00436956|O2|Outcome|20 mg AZD2171 + 10mg Prednisone Daily|Participants received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone.
1149695|NCT00436956|O1|Outcome|20 mg AZD2171 Daily|Participants received 20 mg AZD2171 (Cediranib) orally daily.
1149696|NCT00436956|O2|Outcome|20 mg AZD2171 + 10mg Prednisone Daily|Participants received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone.
1149697|NCT00436956|O1|Outcome|20 mg AZD2171 Daily|Participants received 20 mg AZD2171 (Cediranib) orally daily.
1149698|NCT00436956|O1|Outcome|All Participants- AZD2171 & Prednisone|This group combines participants who received 20 mg AZD2171 (Cediranib) orally daily (n=35), in addition to participants who received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone (n=23). One pt was not evaluable due to a cord compression on day 2 of therapy; was removed from the trial (n=1).
1149699|NCT00436956|O1|Outcome|All Participants - AZD2171 & Prednisone|This group combines participants who received 20 mg AZD2171 (Cediranib) orally daily (n=35), in addition to participants who received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone (n=23). One pt was not evaluable due to a cord compression on day 2 of therapy; was removed from the trial (n=1).
1149700|NCT00436956|E1|Reported Event|All Participants - AZD2171 & Prednisone|This group combines participants who received 20 mg AZD2171 (Cediranib) orally daily (n=35), in addition to participants who received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone (n=23). One pt was not evaluable due to a cord compression on day 2 of therapy; was removed from the trial (n=1).
1149701|NCT00436917|B1|Baseline|Zoledronic Acid|4 mg intravenously over 15 minutes every 6 months (until disease progression or for 5 years)
1149702|NCT00436917|P1|Participant Flow|Zoledronic Acid|4 mg intravenously over 15 minutes every 6 months (until disease progression or for 5 years)
1149703|NCT00436917|O1|Outcome|Zoledronic Acid|4 mg intravenously over 15 minutes every 6 months (until disease progression or for 5 years)
1149704|NCT00436917|E1|Reported Event|Zoledronic Acid|4 mg intravenously over 15 minutes every 6 months (until disease progression or for 5 years)
1149705|NCT00436904|B1|Baseline|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
1149706|NCT00436904|P1|Participant Flow|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
1149947|NCT00436163|O1|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
1149707|NCT00436904|O1|Outcome|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
1149708|NCT00436904|O1|Outcome|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
1149709|NCT00436904|O1|Outcome|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
1149710|NCT00436904|O1|Outcome|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
1149711|NCT00436904|O1|Outcome|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
1149712|NCT00436904|O1|Outcome|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
1150154|NCT00435591|O1|Outcome|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
1149713|NCT00436904|E1|Reported Event|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
1149714|NCT00436852|B3|Baseline|Total|Total of all reporting groups
1149715|NCT00436852|B2|Baseline|Measurable Disease by CT or MRI Scan (ABT-751)|Patients receive oral ABT-751 (200 mg/m2) once daily on days 1-7. Treatment repeats every 21 days for 52 courses in the absence of disease progression or unacceptable toxicity. Quality-of-life assessment at baseline and prior to each course of treatment. A pharmacological study (pharmacokinetic profile of ABT-751) will be determined.
1149716|NCT00436852|B1|Baseline|Disease Evaluable by I-MIBG Scintigraphy (ABT-751)|Patients receive oral ABT-751 (200 mg/m2) once daily on days 1-7. Treatment repeats every 21 days for 52 courses in the absence of disease progression or unacceptable toxicity. Quality-of-life assessment at baseline and prior to each course of treatment. A pharmacological study (pharmacokinetic profile of ABT-751) will be determined.
1149717|NCT00436852|P2|Participant Flow|Measurable Disease by CT or MRI Scan (ABT-751)|Patients receive oral ABT-751 (200 mg/m2) once daily on days 1-7. Treatment repeats every 21 days for 52 courses in the absence of disease progression or unacceptable toxicity. Quality-of-life assessment at baseline and prior to each course of treatment. A pharmacological study (pharmacokinetic profile of ABT-751) will be determined.
1149718|NCT00436852|P1|Participant Flow|Disease Evaluable by I-MIBG Scintigraphy (ABT-751)|Patients receive oral ABT-751 (200 mg/m2) once daily on days 1-7. Treatment repeats every 21 days for 52 courses in the absence of disease progression or unacceptable toxicity. Quality-of-life assessment at baseline and prior to each course of treatment. A pharmacological study (pharmacokinetic profile of ABT-751) will be determined.
1149719|NCT00436852|O2|Outcome|Measurable Disease by CT or MRI Scan (ABT-751)|Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
1149720|NCT00436852|O1|Outcome|Disease Evaluable by I-MIBG Scintigraphy (ABT-751)|Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
1149721|NCT00436852|O2|Outcome|Measurable Disease by CT or MRI Scan (ABT-751)|Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
1149722|NCT00436852|O1|Outcome|Disease Evaluable by I-MIBG Scintigraphy (ABT-751)|Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
1149723|NCT00436852|E2|Reported Event|Measurable Disease by CT or MRI Scan (ABT-751)|Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
1149724|NCT00436852|E1|Reported Event|Disease Evaluable by I-MIBG Scintigraphy (ABT-751)|Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
1149725|NCT00436826|B3|Baseline|Total|Total of all reporting groups
1149726|NCT00436826|B2|Baseline|Placebo, IFN-beta|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the double blind (DB) period of 96 weeks. After completing DB period, participants entered in OL extension period. In OL extension period, participant who met eligibility criteria received OL oral cladribine 3.5 mg/kg and participants participants who did not meet the eligibility criteria received IFN-beta only and were followed for safety only.
1149727|NCT00436826|B1|Baseline|Cladribine 3.5 mg/kg, IFN-beta|Participants received cladribine tablets orally as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (Rebif® new formulation [RNF] 44 microgram [mcg] three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the double blind (DB) period of 96 weeks. After completing DB period, participants entered in OL extension period. In OL extension period, participant who met eligibility criteria received OL oral cladribine 3.5 mg/kg and participants who did not meet the eligibility criteria received IFN-beta only and were followed for safety only.
1149728|NCT00436826|P6|Participant Flow|Placebo, IFN-beta (Safety Follow up)|Participants who received placebo initially and completed DB period entered in the OL ext. safety follow up period. In this period, participants who did not meet eligibility criteria received only IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
1149729|NCT00436826|P5|Participant Flow|Cladribine 3.5 mg/kg, IFN-beta (Safety Follow up)|Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the OL ext. safety follow up period. In this period, participants who did not meet eligibility criteria received only IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
1149902|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
1149730|NCT00436826|P4|Participant Flow|Placebo, IFN-beta, Cladribine 3.5 mg/kg (OL Ext)|Participants who received placebo initially and completed DB period entered in the OL Ext. period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
1149731|NCT00436826|P3|Participant Flow|Cladribine 3.5 mg/kg, IFN-beta, Cladribine 3.5 mg/kg (OL Ext)|Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the open label (OL) extension (Ext.) period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
1149732|NCT00436826|P2|Participant Flow|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
1151168|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
1149733|NCT00436826|P1|Participant Flow|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (Rebif® new formulation [RNF] 44 microgram [mcg] three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the double blind (DB) period of 96 weeks.
1149734|NCT00436826|O2|Outcome|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
1149735|NCT00436826|O1|Outcome|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
1149736|NCT00436826|O2|Outcome|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
1149737|NCT00436826|O1|Outcome|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
1149738|NCT00436826|O2|Outcome|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
1149739|NCT00436826|O1|Outcome|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
1149740|NCT00436826|O2|Outcome|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
1149741|NCT00436826|O1|Outcome|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
1149742|NCT00436826|O2|Outcome|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
1149743|NCT00436826|O1|Outcome|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
1149744|NCT00436826|O2|Outcome|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
1149946|NCT00436163|O1|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
1149745|NCT00436826|O1|Outcome|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
1149746|NCT00436826|E6|Reported Event|Placebo, IFN-beta (Safety Follow up)|Participants who received placebo initially and completed DB period entered in the OL ext. safety follow up period. In this period, participants who did not meet eligibility criteria received only IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
1149747|NCT00436826|E5|Reported Event|Cladribine 3.5 mg/kg, IFN-beta (Safety Follow up)|Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the OL ext. safety follow up period. In this period, participants who did not meet eligibility criteria received only IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
1149795|NCT00436644|E1|Reported Event|Lapatinib + Topotecan|Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
1149796|NCT00436618|B4|Baseline|Total|Total of all reporting groups
1150155|NCT00435591|O4|Outcome|Dose Regimen 4|Conivaptan loading dose (20mg)+20mg/day continuous infusion conivaptan per premix bag
1149748|NCT00436826|E4|Reported Event|Placebo, IFN-beta, Cladribine 3.5 mg/kg (OL Ext)|Participants who received placebo initially and completed DB period entered in the OL Ext. period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
1149749|NCT00436826|E3|Reported Event|Cladribine 3.5 mg/kg, IFN-beta, Cladribine 3.5 mg/kg (OL Ext)|Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the open label (OL) extension (Ext.) period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
1149750|NCT00436826|E2|Reported Event|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
1149751|NCT00436826|E1|Reported Event|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
1149752|NCT00436748|B3|Baseline|Total|Total of all reporting groups
1149753|NCT00436748|B2|Baseline|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149754|NCT00436748|B1|Baseline|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149755|NCT00436748|P2|Participant Flow|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149756|NCT00436748|P1|Participant Flow|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149757|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149758|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149810|NCT00436618|O2|Outcome|Relapsed Indolent Non-Hodgkin Lymphoma|"Study 2.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
1151470|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
1149759|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149760|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149761|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149762|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149964|NCT00436046|O3|Outcome|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
1149763|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149764|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149765|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149766|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149767|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149768|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149769|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149770|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149771|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149772|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1151471|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
1149773|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149774|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149775|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149776|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149965|NCT00436046|O2|Outcome|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
1150156|NCT00435591|O3|Outcome|Dose Regimen 3|Placebo loading dose + 20mg/day continuous infusion conivaptan per premix bag
1149777|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149778|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149779|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149780|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149781|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149782|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149783|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149784|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149785|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149786|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149787|NCT00436748|E2|Reported Event|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149788|NCT00436748|E1|Reported Event|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
1149789|NCT00436644|B1|Baseline|Lapatinib + Topotecan|Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
1149790|NCT00436644|P1|Participant Flow|Lapatinib + Topotecan|Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
1149791|NCT00436644|O1|Outcome|Lapatinib + Topotecan|Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
1149792|NCT00436644|O1|Outcome|Lapatinib + Topotecan|Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
1149793|NCT00436644|O1|Outcome|Lapatinib + Topotecan|Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
1149794|NCT00436644|O1|Outcome|Lapatinib + Topotecan|Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
1156711|NCT00420017|E2|Reported Event|Control|Control usual care
1149797|NCT00436618|B3|Baseline|Uncommon Lymphomas|"Study 3. Includes Hodgkin's lymphomas.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
1149798|NCT00436618|B2|Baseline|Relapsed Indolent Non-Hodgkin Lymphoma|"Study 2.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
1149799|NCT00436618|B1|Baseline|Relapsed Aggressive Non-Hodgkin Lymphoma|"Study 1.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
1149800|NCT00436618|P3|Participant Flow|Uncommon Lymphomas|"Study 3. Includes Hodgkin's lymphomas.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
1149801|NCT00436618|P2|Participant Flow|Relapsed Indolent Non-Hodgkin Lymphoma|"Study 2.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
1149802|NCT00436618|P1|Participant Flow|Relapsed Aggressive Non-Hodgkin Lymphoma|"Study 1.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
1149803|NCT00436618|O3|Outcome|Uncommon Lymphomas|"Study 3. Includes Hodgkin's lymphomas.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
1149804|NCT00436618|O2|Outcome|Relapsed Indolent Non-Hodgkin Lymphoma|"Study 2.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
1149805|NCT00436618|O1|Outcome|Relapsed Aggressive Non-Hodgkin Lymphoma|"Study 1.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
1149806|NCT00436618|O3|Outcome|Uncommon Lymphomas|"Study 3. Includes Hodgkin's lymphomas.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
1149807|NCT00436618|O2|Outcome|Relapsed Indolent Non-Hodgkin Lymphoma|"Study 2.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
1149808|NCT00436618|O1|Outcome|Relapsed Aggressive Non-Hodgkin Lymphoma|"Study 1.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
1149809|NCT00436618|O3|Outcome|Uncommon Lymphomas|"Study 3. Includes Hodgkin's lymphomas.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
1150197|NCT00435539|E1|Reported Event|Ocriplasmin 75µg|Ocriplasmin 75µg single injection versus sham injection
1149811|NCT00436618|O1|Outcome|Relapsed Aggressive Non-Hodgkin Lymphoma|"Study 1.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
1149812|NCT00436618|O3|Outcome|Uncommon Lymphomas|"Study 3. Includes Hodgkin's lymphomas.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
1149813|NCT00436618|O2|Outcome|Relapsed Indolent Non-Hodgkin Lymphoma|"Study 2.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
1149814|NCT00436618|O1|Outcome|Relapsed Aggressive Non-Hodgkin Lymphoma|"Study 1.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
1149815|NCT00436618|E3|Reported Event|Uncommon Lymphomas|"Study 3. Includes Hodgkin's lymphomas.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
1150059|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
1149816|NCT00436618|E2|Reported Event|Relapsed Indolent Non-Hodgkin Lymphoma|"Study 2.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
1149817|NCT00436618|E1|Reported Event|Relapsed Aggressive Non-Hodgkin Lymphoma|"Study 1.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
1149818|NCT00436605|B1|Baseline|Treatment (Kinase Inhibitor Therapy)|Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
1149819|NCT00436605|P1|Participant Flow|Treatment (Kinase Inhibitor Therapy)|Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1149820|NCT00436605|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1149821|NCT00436605|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1149822|NCT00436605|E1|Reported Event|Treatment (Kinase Inhibitor Therapy)|Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1149823|NCT00436566|B1|Baseline|AC/PTL|Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
1149824|NCT00436566|P1|Participant Flow|AC/PTL|Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
1149825|NCT00436566|O1|Outcome|AC/PTL|Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
1149826|NCT00436566|E1|Reported Event|AC/PTL|Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
1149827|NCT00436553|B4|Baseline|Total|Total of all reporting groups
1149828|NCT00436553|B3|Baseline|Ranibizumab Monotherapy|Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
1149829|NCT00436553|B2|Baseline|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
1149830|NCT00436553|B1|Baseline|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
1149831|NCT00436553|P3|Participant Flow|Ranibizumab Monotherapy|Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
1149868|NCT00436436|O1|Outcome|O6-benzylguanine & Temozolomide in Glioblastoma|"Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine~temozolomide"
1152775|NCT00428974|O2|Outcome|CF101 2 mg BID|Oral tablets given every 12 hours for 12 weeks
1149832|NCT00436553|P2|Participant Flow|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
1149833|NCT00436553|P1|Participant Flow|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
1149834|NCT00436553|O2|Outcome|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
1149835|NCT00436553|O1|Outcome|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
1149836|NCT00436553|O3|Outcome|Ranibizumab Monotherapy|Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
1149845|NCT00436553|O3|Outcome|Ranibizumab Monotherapy|Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
1149837|NCT00436553|O2|Outcome|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
1149838|NCT00436553|O1|Outcome|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
1149839|NCT00436553|O3|Outcome|Ranibizumab Monotherapy|Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
1149958|NCT00436046|P3|Participant Flow|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
1149840|NCT00436553|O2|Outcome|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
1149841|NCT00436553|O1|Outcome|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
1149842|NCT00436553|O3|Outcome|Ranibizumab Monotherapy|Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
1149843|NCT00436553|O2|Outcome|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
1149844|NCT00436553|O1|Outcome|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
1149846|NCT00436553|O2|Outcome|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
1149847|NCT00436553|O1|Outcome|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
1149959|NCT00436046|P2|Participant Flow|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
1152776|NCT00428974|O1|Outcome|CF101 1 mg BID|Oral tablets given every 12 hours for 12 weeks
1149848|NCT00436553|E3|Reported Event|Ranibizumab Monotherapy|Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
1149849|NCT00436553|E2|Reported Event|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
1149850|NCT00436553|E1|Reported Event|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
1149851|NCT00436501|B3|Baseline|Total|Total of all reporting groups
1149852|NCT00436501|B2|Baseline|Phase II VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
1149853|NCT00436501|B1|Baseline|Phase I VEGF Trap, Docetaxel|Phase I VEGF Trap starting dose 2 mg/kg intravenous (IV) over 1 hour on day 1 of course 1, then VEGF Trap IV and Docetaxel 75 mg/m^2 IV over 1 hour on day 1 in all subsequent courses. Courses repeat every 21 days. Escalating doses of VEGF Trap (2, 4, or 6 mg/kg) until maximum tolerated dose (MTD) determined.
1149854|NCT00436501|P2|Participant Flow|Phase II: VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
1149855|NCT00436501|P1|Participant Flow|Phase I VEGF Trap, Docetaxel|Phase I VEGF Trap starting dose 2 mg/kg intravenous (IV) over 1 hour on day 1 of course 1, then VEGF Trap IV and Docetaxel 75 mg/m^2 IV over 1 hour on day 1 in all subsequent courses. Courses repeat every 21 days. Escalating doses of VEGF Trap (2, 4, or 6 mg/kg) until maximum tolerated dose (MTD) determined.
1149856|NCT00436501|O1|Outcome|Phase II: VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
1149857|NCT00436501|O1|Outcome|Phase II: VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
1149858|NCT00436501|O1|Outcome|Phase II: VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
1149859|NCT00436501|O1|Outcome|Phase II: VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
1149860|NCT00436501|O2|Outcome|Phase II: VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
1149861|NCT00436501|O1|Outcome|Phase I VEGF Trap, Docetaxel|Phase I VEGF Trap starting dose 2 mg/kg intravenous (IV) over 1 hour on day 1 of course 1, then VEGF Trap IV and Docetaxel 75 mg/m^2 IV over 1 hour on day 1 in all subsequent courses. Courses repeat every 21 days. Escalating doses of VEGF Trap (2, 4, or 6 mg/kg) until maximum tolerated dose (MTD) determined.
1149862|NCT00436501|O1|Outcome|Phase I VEGF Trap, Docetaxel|Phase I VEGF Trap starting dose 2 mg/kg intravenous (IV) over 1 hour on day 1 of course 1, then VEGF Trap IV and Docetaxel 75 mg/m^2 IV over 1 hour on day 1 in all subsequent courses. Courses repeat every 21 days. Escalating doses of VEGF Trap (2, 4, or 6 mg/kg) until maximum tolerated dose (MTD) determined.
1149863|NCT00436501|E2|Reported Event|Phase II: VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
1149864|NCT00436501|E1|Reported Event|Phase I VEGF Trap, Docetaxel|Phase I VEGF Trap starting dose 2 mg/kg intravenous (IV) over 1 hour on day 1 of course 1, then VEGF Trap IV and Docetaxel 75 mg/m^2 IV over 1 hour on day 1 in all subsequent courses. Courses repeat every 21 days. Escalating doses of VEGF Trap (2, 4, or 6 mg/kg) until maximum tolerated dose (MTD) determined.
1149865|NCT00436436|B1|Baseline|O6-benzylguanine & Temozolomide in Glioblastoma|"Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine~temozolomide"
1149866|NCT00436436|P1|Participant Flow|O6-benzylguanine & Temozolomide in Glioblastoma|"Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine~temozolomide"
1149867|NCT00436436|O1|Outcome|O6-benzylguanine & Temozolomide in Glioblastoma|"Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine~temozolomide"
1149960|NCT00436046|P1|Participant Flow|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
1149869|NCT00436436|O1|Outcome|O6-benzylguanine & Temozolomide in Glioblastoma|"Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine~temozolomide"
1149870|NCT00436436|O1|Outcome|O6-benzylguanine & Temozolomide in Glioblastoma|"Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine~temozolomide"
1149871|NCT00436436|O1|Outcome|O6-benzylguanine & Temozolomide in Glioblastoma|"Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine~temozolomide"
1149872|NCT00436436|O1|Outcome|O6-benzylguanine & Temozolomide in Glioblastoma|"Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine~temozolomide"
1149873|NCT00436436|E1|Reported Event|O6-benzylguanine & Temozolomide in Glioblastoma|"Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine~temozolomide"
1149874|NCT00436345|B3|Baseline|Total|Total of all reporting groups
1149875|NCT00436345|B2|Baseline|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
1149876|NCT00436345|B1|Baseline|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
1149877|NCT00436345|P2|Participant Flow|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
1149878|NCT00436345|P1|Participant Flow|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
1149879|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
1149880|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
1149881|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
1149882|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
1149883|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
1150198|NCT00435487|B3|Baseline|Total|Total of all reporting groups
1149884|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
1149885|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
1149886|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
1149887|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per killograms per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
1149888|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
1149961|NCT00436046|O3|Outcome|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
1149889|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
1149890|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
1149891|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
1149892|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
1149893|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
1149894|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
1149895|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
1149896|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
1149897|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
1149898|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
1149899|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
1149900|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
1149901|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
1149903|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
1149904|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
1149905|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
1149906|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
1149962|NCT00436046|O2|Outcome|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
1150065|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
1149907|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
1149908|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
1149909|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
1149910|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
1149911|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
1149912|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
1149913|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
1149914|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
1149915|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
1149916|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
1149917|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
1149918|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
1149919|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
1149920|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
1149921|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
1149922|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
1149923|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
1149924|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
1149963|NCT00436046|O1|Outcome|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
1152777|NCT00428974|O4|Outcome|Placebo|Oral tablets given every 12 hours for 12 weeks
1149925|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
1149926|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
1149927|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
1149928|NCT00436345|E2|Reported Event|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
1149929|NCT00436345|E1|Reported Event|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
1149930|NCT00436332|B1|Baseline|Erlotinib and Bevacizumab|Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
1149931|NCT00436332|P1|Participant Flow|Erlotinib and Bevacizumab|Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
1149932|NCT00436332|O1|Outcome|Erlotinib and Bevacizumab|Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
1149933|NCT00436332|O1|Outcome|Erlotinib and Bevacizumab|Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
1149934|NCT00436332|O1|Outcome|Erlotinib and Bevacizumab|Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
1149935|NCT00436332|O1|Outcome|Erlotinib and Bevacizumab|Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
1149936|NCT00436332|E1|Reported Event|Erlotinib and Bevacizumab|Patients receive oral erlotinib hydrochloride once daily on days 1-21 and bevacizumab IV over 30-90 minutes on day 1.
1149937|NCT00436215|B1|Baseline|BAY 43-9006 + Bevacizumab|"BAY 43-9006 (sorafenib) + Bevacizumab~Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks~BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)"
1149938|NCT00436215|P1|Participant Flow|BAY 43-9006 + Bevacizumab|"BAY 43-9006 (sorafenib) + Bevacizumab~Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks~BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)"
1149939|NCT00436215|O1|Outcome|BAY 43-9006 + Bevacizumab|"BAY 43-9006 (sorafenib) + Bevacizumab~Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks~BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)"
1149940|NCT00436215|O1|Outcome|BAY 43-9006 + Bevacizumab|"BAY 43-9006 (sorafenib) + Bevacizumab~Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks~BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)"
1149941|NCT00436215|O1|Outcome|BAY 43-9006 + Bevacizumab|"BAY 43-9006 (sorafenib) + Bevacizumab~Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks~BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)"
1149942|NCT00436215|E1|Reported Event|BAY 43-9006 + Bevacizumab|"BAY 43-9006 (sorafenib) + Bevacizumab~Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks~BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)"
1149943|NCT00436163|B1|Baseline|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
1149944|NCT00436163|P1|Participant Flow|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys®) 180 micrograms (mcg) subcutaneously once per week for 48 weeks.
1149945|NCT00436163|O1|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
1150250|NCT00435188|B3|Baseline|Total|Total of all reporting groups
1149948|NCT00436163|O1|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys)180 mcg subcutaneously once per week for 48 weeks.
1149949|NCT00436163|O1|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys)180 mcg subcutaneously once per week for 48 weeks.
1149950|NCT00436163|O1|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
1149951|NCT00436163|O1|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
1149952|NCT00436163|O1|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
1149953|NCT00436163|E1|Reported Event|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
1149954|NCT00436046|B4|Baseline|Total|Total of all reporting groups
1149955|NCT00436046|B3|Baseline|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
1149956|NCT00436046|B2|Baseline|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
1149957|NCT00436046|B1|Baseline|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
1149966|NCT00436046|O1|Outcome|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
1149967|NCT00436046|O3|Outcome|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
1149968|NCT00436046|O2|Outcome|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
1149969|NCT00436046|O1|Outcome|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
1149970|NCT00436046|O3|Outcome|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
1149971|NCT00436046|O2|Outcome|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
1149972|NCT00436046|O1|Outcome|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
1149973|NCT00436046|O3|Outcome|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
1149974|NCT00436046|O2|Outcome|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
1149975|NCT00436046|O1|Outcome|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
1149976|NCT00436046|O3|Outcome|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
1149977|NCT00436046|O2|Outcome|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
1149978|NCT00436046|O1|Outcome|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
1149979|NCT00436046|O3|Outcome|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
1149980|NCT00436046|O2|Outcome|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
1149981|NCT00436046|O1|Outcome|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
1149982|NCT00436046|O3|Outcome|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
1149983|NCT00436046|O2|Outcome|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
1149984|NCT00436046|O1|Outcome|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
1149985|NCT00436046|E3|Reported Event|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
1149986|NCT00436046|E2|Reported Event|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
1149987|NCT00436046|E1|Reported Event|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
1149988|NCT00436007|B4|Baseline|Total|Total of all reporting groups
1149989|NCT00436007|B3|Baseline|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1149990|NCT00436007|B2|Baseline|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1150093|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
1149991|NCT00436007|B1|Baseline|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
1149992|NCT00436007|P3|Participant Flow|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1150060|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
1150104|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
1149993|NCT00436007|P2|Participant Flow|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1149994|NCT00436007|P1|Participant Flow|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
1149995|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1149996|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1149997|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
1149998|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1149999|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1150045|NCT00435994|O2|Outcome|Bronchiolitis and Respiratory Syncytial Virus-Nasal Wash Only|Infants 2 months to 24 months who were diagnosed with bronchiolitis and respiratory syncytial virus received nasal wash only.
1150046|NCT00435994|O1|Outcome|Healthy Control|Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity
1150047|NCT00435994|O2|Outcome|Respiratory Syncytial Virus|Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by a URI
1150000|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
1150001|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1150002|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1150061|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
1150157|NCT00435591|O2|Outcome|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
1150003|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
1150004|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1150005|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1150006|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
1150007|NCT00436007|O1|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1150008|NCT00436007|O1|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1150009|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
1150010|NCT00436007|O2|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1150011|NCT00436007|O1|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1150012|NCT00436007|O2|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1150062|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
1152778|NCT00428974|O3|Outcome|CF101 4 mg BID|Oral tablets given every 12 hours for 12 weeks
1150013|NCT00436007|O1|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1150014|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1150015|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1150016|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
1150017|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1150018|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1150019|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
1150020|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1150021|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1150022|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
1150063|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
1150105|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
1150023|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1150024|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1150025|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
1150026|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania
1150027|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1150028|NCT00436007|O1|Outcome|GSK 257049 1 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1150029|NCT00436007|O1|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1150030|NCT00436007|O1|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1150031|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
1150032|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1150064|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
1152779|NCT00428974|O2|Outcome|CF101 2 mg BID|Oral tablets given every 12 hours for 12 weeks
1150033|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1150034|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
1150035|NCT00436007|E3|Reported Event|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1150036|NCT00436007|E2|Reported Event|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
1150037|NCT00436007|E1|Reported Event|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
1150038|NCT00435994|B4|Baseline|Total|Total of all reporting groups
1150039|NCT00435994|B3|Baseline|Bronchiolitis|Infants 2 months to 24 months who were diagnosed with bronchiolitis received nasal wash only.
1150040|NCT00435994|B2|Baseline|Respiratory Syncytial Virus|Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by a URI
1150041|NCT00435994|B1|Baseline|Healthy Control|Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity
1150042|NCT00435994|P3|Participant Flow|Bronchiolitis-Nasal Wash Only|Infants 2 months to 24 months who were diagnosed with bronchiolitis received nasal wash only.
1150043|NCT00435994|P2|Participant Flow|Respiratory Syncytial Virus|Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by a URI
1150044|NCT00435994|P1|Participant Flow|Healthy Control|Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity
1150092|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
1150048|NCT00435994|O1|Outcome|Healthy Control|Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity had spirometry performed under sedation.
1150049|NCT00435994|E3|Reported Event|Bronchiolitis|
1150050|NCT00435994|E2|Reported Event|Respiratory Syncytial Virus|
1150051|NCT00435994|E1|Reported Event|Healthy Control|
1150052|NCT00435929|B3|Baseline|Total|Total of all reporting groups
1150053|NCT00435929|B2|Baseline|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
1150054|NCT00435929|B1|Baseline|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
1150055|NCT00435929|P2|Participant Flow|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
1150056|NCT00435929|P1|Participant Flow|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
1150057|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
1150058|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
1150106|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
1150066|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
1150067|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
1150068|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
1150069|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
1150070|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
1150071|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
1150072|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
1150073|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
1150074|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
1150075|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
1150076|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
1150077|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
1150078|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
1150079|NCT00435929|E2|Reported Event|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
1150080|NCT00435929|E1|Reported Event|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
1150081|NCT00435825|B5|Baseline|Total|Total of all reporting groups
1150082|NCT00435825|B4|Baseline|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
1150083|NCT00435825|B3|Baseline|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
1150084|NCT00435825|B2|Baseline|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
1150085|NCT00435825|B1|Baseline|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
1150086|NCT00435825|P4|Participant Flow|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
1150087|NCT00435825|P3|Participant Flow|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
1150088|NCT00435825|P2|Participant Flow|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
1150089|NCT00435825|P1|Participant Flow|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
1150090|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
1150091|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
1150195|NCT00435539|E3|Reported Event|Ocriplasmin 175µg Single Injection|Ocriplasmin 175µg single injection versus sham injection
1150094|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
1150095|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
1150096|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
1150097|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
1150098|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
1150099|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
1150100|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
1150101|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
1150102|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
1150103|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
1152780|NCT00428974|O1|Outcome|CF101 1 mg Twice Daily (BID)|Oral tablets given every 12 hours for 12 weeks
1150107|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
1150108|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
1150109|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
1150110|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
1150111|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
1150112|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
1150113|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
1150114|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
1150115|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
1150116|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
1150117|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
1150118|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
1150119|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
1150120|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
1150121|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
1150122|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
1150123|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
1150124|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
1150125|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
1150126|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
1150127|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
1150128|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
1150129|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
1150130|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
1150131|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
1150132|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
1150133|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
1150134|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
1150135|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
1150136|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
1150137|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
1150138|NCT00435825|E4|Reported Event|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
1150139|NCT00435825|E3|Reported Event|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
1150140|NCT00435825|E2|Reported Event|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
1150141|NCT00435825|E1|Reported Event|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
1150142|NCT00435591|B5|Baseline|Total|Total of all reporting groups
1150143|NCT00435591|B4|Baseline|Dose Regimen 4|Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
1150144|NCT00435591|B3|Baseline|Dose Regimen 3|Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
1150145|NCT00435591|B2|Baseline|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
1150146|NCT00435591|B1|Baseline|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
1150147|NCT00435591|P4|Participant Flow|Dose Regimen 4|Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
1150148|NCT00435591|P3|Participant Flow|Dose Regimen 3|Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
1150149|NCT00435591|P2|Participant Flow|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
1150150|NCT00435591|P1|Participant Flow|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
1156712|NCT00420017|E1|Reported Event|Amiodarone|Intravenous amiodarone
1150158|NCT00435591|O1|Outcome|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
1150159|NCT00435591|O1|Outcome|Dose Regimen 3|Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
1150160|NCT00435591|O4|Outcome|Dose Regimen 4|Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
1150161|NCT00435591|O3|Outcome|Dose Regimen 3|Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
1150162|NCT00435591|O2|Outcome|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
1150163|NCT00435591|O1|Outcome|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
1150164|NCT00435591|O4|Outcome|Dose Regimen 4|Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
1150165|NCT00435591|O3|Outcome|Dose Regimen 3|Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
1150166|NCT00435591|O2|Outcome|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
1150167|NCT00435591|O1|Outcome|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
1150168|NCT00435591|O2|Outcome|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
1150169|NCT00435591|O1|Outcome|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
1150170|NCT00435591|E4|Reported Event|Dose Regimen 4|Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
1150171|NCT00435591|E3|Reported Event|Dose Regimen 3|Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
1150172|NCT00435591|E2|Reported Event|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
1150173|NCT00435591|E1|Reported Event|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
1150174|NCT00435539|B6|Baseline|Total|Total of all reporting groups
1150175|NCT00435539|B5|Baseline|Sham Injection|sham injection
1150176|NCT00435539|B4|Baseline|Ocriplasmin 125µg Multiple Injections|ocriplasmin 125µg multiple injections Subjects who did not achieve resolution of VMT by the day 28 visit (i.e. non-responders) were given an open-label injection of ocriplasmin 125 μg. Subjects who still did not achieve resolution of VMT by the day 56 visit were given a second open-label injection of ocriplasmin 125 μg.
1150177|NCT00435539|B3|Baseline|Ocriplasmin 175µg Single Injection|ocriplasmin 175µg single injection versus sham injection
1150178|NCT00435539|B2|Baseline|Ocriplasmin 125µg Single Injection|ocriplasmin 125µg single injection versus sham injection
1150179|NCT00435539|B1|Baseline|Ocriplasmin 75µg Single Injection|ocriplasmin 75µg single injection versus sham injection
1150180|NCT00435539|P5|Participant Flow|Sham Injection|sham injection
1150181|NCT00435539|P4|Participant Flow|Ocriplasmin 125µg Multiple Injections|ocriplasmin 125µg multiple injections. Subjects who did not achieve resolution of VMT by the day 28 visit (i.e. non-responders) were given an open-label injection of ocriplasmin 125 μg. Subjects who still did not achieve resolution of VMT by the day 56 visit were given a second open-label injection of ocriplasmin 125 μg.
1150182|NCT00435539|P3|Participant Flow|Ocriplasmin 175µg Single Injection|ocriplasmin 175µg single injection versus sham injection
1150183|NCT00435539|P2|Participant Flow|Ocriplasmin 125µg Single Injection|ocriplasmin 125µg single injection versus sham injection
1150184|NCT00435539|P1|Participant Flow|Ocriplasmin 75µg Single Injection|Ocriplasmin 75µg single injection versus sham injection
1150185|NCT00435539|O4|Outcome|Sham Injection|sham injection
1150186|NCT00435539|O3|Outcome|Ocriplasmin 125µg Pooled|Pooled data for ocriplasmin 125µg and ocriplasmin 125µg multiple injections versus sham injection
1150187|NCT00435539|O2|Outcome|Ocriplasmin 175µg Single Injection|Ocriplasmin 175µg single injection versus sham injection
1150188|NCT00435539|O1|Outcome|Ocriplasmin 75µg Single Injection|Ocriplasmin 75µg single injection versus sham injection
1150189|NCT00435539|O4|Outcome|Sham Injection|sham injection
1150190|NCT00435539|O3|Outcome|Ocriplasmin 125µg Pooled|Pooled data for ocriplasmin 125µg and ocriplasmin 125µg multiple injections versus sham injection
1150191|NCT00435539|O2|Outcome|Ocriplasmin 175µg Single Injection|Ocriplasmin 175µg single injection versus sham injection
1150192|NCT00435539|O1|Outcome|Ocriplasmin 75µg Single Injection|Ocriplasmin 75µg single injection versus sham injection
1150193|NCT00435539|E5|Reported Event|Sham Injection|Sham injection
1150194|NCT00435539|E4|Reported Event|Ocriplasmin 125µg Multiple Injection|Ocriplasmin 125µg multiple injection versus sham injection
1150199|NCT00435487|B2|Baseline|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
1150200|NCT00435487|B1|Baseline|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
1150201|NCT00435487|P2|Participant Flow|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
1150224|NCT00435409|O1|Outcome|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
1150202|NCT00435487|P1|Participant Flow|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
1150203|NCT00435487|O2|Outcome|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
1150204|NCT00435487|O1|Outcome|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
1150205|NCT00435487|O2|Outcome|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
1150206|NCT00435487|O1|Outcome|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
1150207|NCT00435487|O2|Outcome|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
1150208|NCT00435487|O1|Outcome|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
1150209|NCT00435487|O2|Outcome|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
1150210|NCT00435487|O1|Outcome|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
1150211|NCT00435487|O2|Outcome|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
1150212|NCT00435487|O1|Outcome|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
1150213|NCT00435487|O2|Outcome|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
1150214|NCT00435487|O1|Outcome|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
1150215|NCT00435487|E2|Reported Event|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
1150216|NCT00435487|E1|Reported Event|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
1150217|NCT00435409|B3|Baseline|Total|Total of all reporting groups
1150218|NCT00435409|B2|Baseline|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
1150251|NCT00435188|B2|Baseline|Arm 2|Usual care
1150219|NCT00435409|B1|Baseline|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
1150220|NCT00435409|P3|Participant Flow|Capecitabine, Crossover to Sunitinib|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
1150221|NCT00435409|P2|Participant Flow|Capecitabine, no Crossover|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks.
1150222|NCT00435409|P1|Participant Flow|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 milligrams (mg) once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 milligrams per square meter (mg/m^2) per day (1000 mg/m^2 twice daily [BID]) from Days 1-14 every 3 weeks.
1150223|NCT00435409|O2|Outcome|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
1150225|NCT00435409|O2|Outcome|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
1150226|NCT00435409|O1|Outcome|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
1150227|NCT00435409|O2|Outcome|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
1150228|NCT00435409|O1|Outcome|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
1150229|NCT00435409|O2|Outcome|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
1150230|NCT00435409|O1|Outcome|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
1150231|NCT00435409|O2|Outcome|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
1150232|NCT00435409|O1|Outcome|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
1150233|NCT00435409|O2|Outcome|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
1150234|NCT00435409|O1|Outcome|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
1150235|NCT00435409|O2|Outcome|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
1150236|NCT00435409|O1|Outcome|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
1150237|NCT00435409|O2|Outcome|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
1150238|NCT00435409|O1|Outcome|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
1150239|NCT00435409|E2|Reported Event|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
1150240|NCT00435409|E1|Reported Event|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
1150241|NCT00435370|B3|Baseline|Total|Total of all reporting groups
1150242|NCT00435370|B2|Baseline|Placebo|Placebo + risperidone (6mg/day)
1150243|NCT00435370|B1|Baseline|Tropisetron|Tropisetron (10mg/day) + risperidone(6mg/day)
1150244|NCT00435370|P2|Participant Flow|Placebo|Placebo + risperidone (6mg/day)
1150245|NCT00435370|P1|Participant Flow|Tropisetron|Tropisetron (10mg/day) + risperidone(6mg/day)
1150246|NCT00435370|O2|Outcome|Placebo|Placebo + risperidone (6mg/day)
1150247|NCT00435370|O1|Outcome|Tropisetron|Tropisetron (10mg/day) + risperidone(6mg/day)
1150248|NCT00435370|E2|Reported Event|Placebo|Placebo + risperidone (6mg/day)
1150249|NCT00435370|E1|Reported Event|Tropisetron|Tropisetron (10mg/day) + risperidone(6mg/day)
1150252|NCT00435188|B1|Baseline|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic vis
1150253|NCT00435188|P2|Participant Flow|Arm 2, Usual Care|Usual care participants were asked to continue their normal activities and offered a 3-month physical activity counseling program upon completion of the trial
1150254|NCT00435188|P1|Participant Flow|Arm 1, Physical Activity Counseling|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
1150255|NCT00435188|O2|Outcome|Arm 2|Usual care
1150256|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
1150257|NCT00435188|O2|Outcome|Arm 2|Usual care
1150258|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
1150259|NCT00435188|O2|Outcome|Arm 2|Usual care
1150260|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
1150261|NCT00435188|O2|Outcome|Arm 2|Usual care
1150262|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
1150263|NCT00435188|O2|Outcome|Arm 2|Usual care
1150264|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
1150265|NCT00435188|O2|Outcome|Arm 2|Usual care
1150266|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
1150267|NCT00435188|O2|Outcome|Arm 2|Usual care
1150268|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
1150269|NCT00435188|O2|Outcome|Arm 2|Usual care
1150270|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
1150271|NCT00435188|O2|Outcome|Arm 2|Usual care
1150331|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
1150535|NCT00434434|B1|Baseline|Liquid Omalizumab|Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
1150272|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
1150273|NCT00435188|O2|Outcome|Arm 2, Usual Care|Usual care participants were asked to continue their normal activities and offered a 3-month physical activity counseling program upon completion of the trial
1150274|NCT00435188|O1|Outcome|Arm 1, Physical Activity Counseling|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
1150275|NCT00435188|O2|Outcome|Arm 2|Usual care
1150299|NCT00435162|P4|Participant Flow|Medium Dose, Then Placebo|Valsartan 1.0 mg/kg, then placebo
1150300|NCT00435162|P3|Participant Flow|Medium Dose in Both Periods|Valsartan 1.0 mg/kg in both periods
1150301|NCT00435162|P2|Participant Flow|Low Dose, Then Placebo|Valsartan 0.25 mg/kg, then placebo
1150276|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
1150277|NCT00435188|O2|Outcome|Arm 2|Usual care
1150278|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
1150279|NCT00435188|O2|Outcome|Arm 2|Usual care
1150280|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
1150281|NCT00435188|O2|Outcome|Arm 2|Usual care
1150282|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
1150283|NCT00435188|O2|Outcome|Arm 2|Usual care
1150284|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
1150285|NCT00435188|O2|Outcome|Arm 2, Usual Care|Usual care participants were asked to continue their normal activities and offered a 3-month physical activity counseling program upon completion of the trial
1150286|NCT00435188|O1|Outcome|Arm 1, Physical Activity Counseling|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
1150287|NCT00435188|O2|Outcome|Arm 2, Usual Care|Usual care participants were asked to continue their normal activities and offered a 3-month physical activity counseling program upon completion of the trial
1150288|NCT00435188|O1|Outcome|Arm 1, Physical Activity Counseling|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
1150289|NCT00435188|O2|Outcome|Arm 2|Usual care
1150332|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
1150290|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
1150291|NCT00435188|E2|Reported Event|Arm 2, Usual Care|Usual care participants were asked to continue their normal activities and offered a 3-month physical activity counseling program upon completion of the trial
1150292|NCT00435188|E1|Reported Event|Arm 1, Physical Activity Counseling|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
1150293|NCT00435162|B4|Baseline|Total|Total of all reporting groups
1150294|NCT00435162|B3|Baseline|High Dose|Extemporaneous suspension of valsartan 4.0 mg/kg, taken once daily
1150295|NCT00435162|B2|Baseline|Medium Dose|Extemporaneous suspension of valsartan 1.0 mg/kg, taken once daily
1150296|NCT00435162|B1|Baseline|Low Dose|Extemporaneous suspension of valsartan 0.25 mg/kg, taken once daily
1150297|NCT00435162|P6|Participant Flow|High Dose, Then Placebo|Valsartan 4.0 mg/kg, then placebo
1150298|NCT00435162|P5|Participant Flow|High Dose in Both Periods|Valsartan 1.0 mg/kg, then placebo
1156713|NCT00420628|B3|Baseline|Total|Total of all reporting groups
1150308|NCT00435162|O2|Outcome|Medium Dose|Extemporaneous suspension of valsartan 1.0 mg/kg, taken once daily
1150309|NCT00435162|O1|Outcome|Low Dose|Extemporaneous suspension of valsartan 0.25 mg/kg, taken once daily
1150310|NCT00435162|O3|Outcome|High Dose|Extemporaneous suspension of valsartan 4.0 mg/kg, taken once daily
1150311|NCT00435162|O2|Outcome|Medium Dose|Extemporaneous suspension of valsartan 1.0 mg/kg, taken once daily
1150312|NCT00435162|O1|Outcome|Low Dose|Extemporaneous suspension of valsartan 0.25 mg/kg, taken once daily
1150313|NCT00435162|E6|Reported Event|High Dose, Then Placebo|Valsartan 4.0 mg/kg, then Placebo
1150314|NCT00435162|E5|Reported Event|High Dose in Both Periods|Valsartan 4.0 mg/kg in both periods
1150315|NCT00435162|E4|Reported Event|Medium Dose, Then Placebo|Valsartan 1.0 mg/kg, then Placebo
1150316|NCT00435162|E3|Reported Event|Medium Dose in Both Periods|Valsartan 1.0 mg/kg in both periods
1150317|NCT00435162|E2|Reported Event|Low Dose, Then Placebo|Valsartan 0.25 mg/kg, then Placebo
1150318|NCT00435162|E1|Reported Event|Low Dose in Both Periods|Valsartan 0.25 mg/kg in both periods
1150319|NCT00435045|B3|Baseline|Total|Total of all reporting groups
1150320|NCT00435045|B2|Baseline|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
1150321|NCT00435045|B1|Baseline|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
1150322|NCT00435045|P2|Participant Flow|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
1150323|NCT00435045|P1|Participant Flow|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
1150324|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
1150325|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
1150326|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
1150327|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
1150328|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
1150329|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
1150330|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
1150532|NCT00434434|B4|Baseline|Total|Total of all reporting groups
1151472|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
1150333|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
1150334|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
1150335|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
1150336|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
1150337|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
1152781|NCT00428974|E4|Reported Event|Placebo|Oral tablets given every 12 hours for 12 weeks
1150338|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
1150339|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
1150340|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
1150341|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
1150342|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
1150343|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
1150344|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
1150345|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
1150346|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
1150347|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
1150348|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
1150349|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
1150350|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
1150351|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
1150352|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
1150353|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
1150354|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
1151473|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
1150355|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
1150356|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
1150357|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
1150358|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
1150359|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
1150547|NCT00434434|E1|Reported Event|Liquid Omalizumab|Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
1150360|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
1150361|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
1150362|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
1150363|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
1150364|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
1150365|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
1150366|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
1150367|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
1150368|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
1150369|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
1150370|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
1150371|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
1150372|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
1150373|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
1150374|NCT00435045|E2|Reported Event|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
1150375|NCT00435045|E1|Reported Event|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
1150376|NCT00435019|B3|Baseline|Total|Total of all reporting groups
1150377|NCT00435019|B2|Baseline|NPH Insulin|Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
1150378|NCT00435019|B1|Baseline|Insulin Detemir|Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
1150379|NCT00435019|P2|Participant Flow|NPH Insulin|Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
1150380|NCT00435019|P1|Participant Flow|Insulin Detemir|Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
1150381|NCT00435019|O2|Outcome|NPH Insulin|Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
1150382|NCT00435019|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
1150383|NCT00435019|O2|Outcome|NPH Insulin|Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
1150384|NCT00435019|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
1150385|NCT00435019|O2|Outcome|NPH Insulin|Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
1150722|NCT00434161|O2|Outcome|Palifermin|Subjects to receive Before- and After chemotherapy, and Before chemotherapy only.
1150386|NCT00435019|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
1150387|NCT00435019|E2|Reported Event|NPH Insulin|Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
1150388|NCT00435019|E1|Reported Event|Insulin Detemir|Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
1150389|NCT00434993|B3|Baseline|Total|Total of all reporting groups
1150390|NCT00434993|B2|Baseline|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
1150391|NCT00434993|B1|Baseline|Albuterol Sulfate|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
1150392|NCT00434993|P2|Participant Flow|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
1150393|NCT00434993|P1|Participant Flow|Albuterol Sulfate|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
1150394|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
1150395|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
1150396|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
1150397|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
1150398|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
1150399|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
1150400|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
1150401|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
1150402|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
1150403|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
1150404|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
1150405|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
1150406|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
1150407|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
1150408|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
1150409|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
1150410|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
1150411|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
1150412|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
1150413|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
1150414|NCT00434993|E2|Reported Event|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
1150415|NCT00434993|E1|Reported Event|Albuterol Sulfate|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
1150416|NCT00434967|B5|Baseline|Total|Total of all reporting groups
1150417|NCT00434967|B4|Baseline|Candesartan/HCT 32/25 mg|candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
1150418|NCT00434967|B3|Baseline|HCT 25 mg|HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)
1150419|NCT00434967|B2|Baseline|Candesartan 32 mg|candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
1150420|NCT00434967|B1|Baseline|Placebo|given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)
1150421|NCT00434967|P4|Participant Flow|Candesartan/HCT 32/25 mg|candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
1151474|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
1150422|NCT00434967|P3|Participant Flow|HCT 25 mg|HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)
1150423|NCT00434967|P2|Participant Flow|Candesartan 32 mg|candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
1150424|NCT00434967|P1|Participant Flow|Placebo|given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)
1150425|NCT00434967|O4|Outcome|Candesartan/HCT 32/25 mg|candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
1150426|NCT00434967|O3|Outcome|HCT 25 mg|HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)
1150427|NCT00434967|O2|Outcome|Candesartan 32 mg|candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
1150460|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
1150428|NCT00434967|O1|Outcome|Placebo|given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)
1150429|NCT00434967|O4|Outcome|Candesartan/HCT 32/25 mg|candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
1150430|NCT00434967|O3|Outcome|HCT 25 mg|HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)
1150431|NCT00434967|O2|Outcome|Candesartan 32 mg|candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
1150432|NCT00434967|O1|Outcome|Placebo|given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)
1150433|NCT00434967|O4|Outcome|Candesartan/HCT 32/25 mg|candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
1150434|NCT00434967|O3|Outcome|HCT 25 mg|HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)
1150435|NCT00434967|O2|Outcome|Candesartan 32 mg|candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
1150436|NCT00434967|O1|Outcome|Placebo|given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)
1150437|NCT00434967|E4|Reported Event|Candesartan/HCT 32/25 mg|candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
1150438|NCT00434967|E3|Reported Event|HCT 25 mg|HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)
1150439|NCT00434967|E2|Reported Event|Candesartan 32 mg|candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
1150440|NCT00434967|E1|Reported Event|Placebo|given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)
1150441|NCT00434954|B3|Baseline|Total|Total of all reporting groups
1150442|NCT00434954|B2|Baseline|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
1150443|NCT00434954|B1|Baseline|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
1150444|NCT00434954|P2|Participant Flow|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
1150445|NCT00434954|P1|Participant Flow|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
1150446|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
1150447|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
1150448|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
1150449|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
1150709|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
1150450|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
1150451|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
1150452|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
1150453|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
1150454|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
1150455|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
1150456|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
1150457|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
1150458|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
1150459|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
1150461|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
1150462|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
1150463|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
1150464|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
1150465|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
1150466|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
1150467|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
1150468|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
1150469|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
1150470|NCT00434954|E2|Reported Event|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
1150471|NCT00434954|E1|Reported Event|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
1150472|NCT00434876|B3|Baseline|Total|Total of all reporting groups
1150473|NCT00434876|B2|Baseline|Placebo|Placebo
1150474|NCT00434876|B1|Baseline|Quetiapine|Quetiapine XR
1150475|NCT00434876|P2|Participant Flow|Placebo|The matching placebo pills were similarly taken at bedtime and the dose was titrated flexibly in the following fashion over the first week: 50 mg dose for 2 nights, followed by 200 mg a night for 2 nights, and then 300 mg a night for 2 nights and to a final dose of 400 mg daily starting on night # 7. Medication taper commenced at week 8 in the reverse stepwise fashion after the second set of two polysomnograms.
1150476|NCT00434876|P1|Participant Flow|Quetiapine XR|The pills were taken at bedtime and the dose was titrated flexibly in the following fashion over the first week: 50 mg dose for 2 nights, followed by 200 mg a night for 2 nights, and then 300 mg a night for 2 nights and to a final dose of 400 mg daily starting on night # 7. Medication taper commenced at week 8 in the reverse stepwise fashion after the second set of two polysomnograms.
1150477|NCT00434876|O2|Outcome|Placebo|Placebo
1150478|NCT00434876|O1|Outcome|Quetiapine XR|Quetiapine XR
1150479|NCT00434876|O2|Outcome|Placebo|Placebo
1150480|NCT00434876|O1|Outcome|Quetiapine XR|Quetiapine XR
1150481|NCT00434876|O2|Outcome|Placebo|Placebo
1150482|NCT00434876|O1|Outcome|Quetiapine XR|Quetiapine XR
1150483|NCT00434876|O2|Outcome|Placebo|Placebo
1150484|NCT00434876|O1|Outcome|Quetiapine XR|Quetiapine XR
1150485|NCT00434876|E2|Reported Event|Placebo|Placebo
1150486|NCT00434876|E1|Reported Event|Quetiapine|Quetiapine XR
1150487|NCT00434759|B3|Baseline|Total|Total of all reporting groups
1150488|NCT00434759|B2|Baseline|Standardtherapy|standard therapy (therapist-guided intervention only)
1150489|NCT00434759|B1|Baseline|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
1150490|NCT00434759|P2|Participant Flow|Standardtherapy|standard therapy (therapist-guided intervention only)
1150491|NCT00434759|P1|Participant Flow|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
1150492|NCT00434759|O2|Outcome|Standardtherapy|standard therapy (therapist-guided intervention only)
1150493|NCT00434759|O1|Outcome|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
1150494|NCT00434759|O2|Outcome|Standardtherapy|standard therapy (therapist-guided intervention only)
1150495|NCT00434759|O1|Outcome|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
1150496|NCT00434759|O2|Outcome|Standardtherapy|standard therapy (therapist-guided intervention only)
1150497|NCT00434759|O1|Outcome|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
1150498|NCT00434759|O2|Outcome|Standardtherapy|standard therapy (therapist-guided intervention only)
1150499|NCT00434759|O1|Outcome|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
1150500|NCT00434759|O2|Outcome|Standardtherapy|standard therapy (therapist-guided intervention only; 16 sessions)
1150501|NCT00434759|O1|Outcome|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission (8 sessions up to 24 sessions)
1150502|NCT00434759|E2|Reported Event|Standardtherapy|standard therapy (therapist-guided intervention only)
1150503|NCT00434759|E1|Reported Event|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
1150504|NCT00434642|B3|Baseline|Total|Total of all reporting groups
1150505|NCT00434642|B2|Baseline|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient’s weight at baseline and remained the same throughout the study.
1150506|NCT00434642|B1|Baseline|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
1150507|NCT00434642|P2|Participant Flow|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient’s weight at baseline and remained the same throughout the study.
1150508|NCT00434642|P1|Participant Flow|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
1150509|NCT00434642|O2|Outcome|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
1150510|NCT00434642|O1|Outcome|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
1150511|NCT00434642|O2|Outcome|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
1150512|NCT00434642|O1|Outcome|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
1150513|NCT00434642|O2|Outcome|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
1150514|NCT00434642|O1|Outcome|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
1150533|NCT00434434|B3|Baseline|Placebo|Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
1150534|NCT00434434|B2|Baseline|Lyopholized Omalizumab|Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
1151475|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
1150515|NCT00434642|O2|Outcome|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
1150516|NCT00434642|O1|Outcome|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
1150517|NCT00434642|O2|Outcome|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
1150518|NCT00434642|O1|Outcome|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
1150546|NCT00434434|E2|Reported Event|Lyopholized Omalizumab|Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
1150519|NCT00434642|O2|Outcome|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
1150520|NCT00434642|O1|Outcome|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
1150521|NCT00434642|E2|Reported Event|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
1150522|NCT00434642|E1|Reported Event|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient’s weight at baseline and remained the same throughout the study.
1150523|NCT00434590|B3|Baseline|Total|Total of all reporting groups
1150524|NCT00434590|B2|Baseline|Standard Dose of Myfortic® and Standard Dose of CsA-ME|Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.
1150525|NCT00434590|B1|Baseline|Full Dose Myfortic® and Reduced Dose Neoral®|The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME
1150526|NCT00434590|P2|Participant Flow|Standard Dose of Myfortic® and Standard Dose of CsA-ME|Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.
1150527|NCT00434590|P1|Participant Flow|Full Dose Myfortic® and Reduced Dose Neoral®|The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME
1150528|NCT00434590|O2|Outcome|Standard Dose of Myfortic® and Standard Dose of CsA-ME|Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.
1150529|NCT00434590|O1|Outcome|Full Dose Myfortic® and Reduced Dose Neoral®|The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME
1150530|NCT00434590|E2|Reported Event|Standard Dose of Myfortic® and Standard Dose of CsA-ME|Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.
1150531|NCT00434590|E1|Reported Event|Full Dose Myfortic® and Reduced Dose Neoral®|The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME
1150536|NCT00434434|P3|Participant Flow|Placebo|Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
1150537|NCT00434434|P2|Participant Flow|Lyopholized Omalizumab|Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
1150538|NCT00434434|P1|Participant Flow|Liquid Omalizumab|Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
1150539|NCT00434434|O3|Outcome|Placebo|Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
1150540|NCT00434434|O2|Outcome|Lyopholized Omalizumab|Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
1150541|NCT00434434|O1|Outcome|Liquid Omalizumab|Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
1150542|NCT00434434|O3|Outcome|Placebo|Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
1150543|NCT00434434|O2|Outcome|Lyopholized Omalizumab|Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
1150544|NCT00434434|O1|Outcome|Liquid Omalizumab|Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
1150545|NCT00434434|E3|Reported Event|Placebo|Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
1150548|NCT00434421|B1|Baseline|German Cockroach Allergen Dosing Group|Initially each subject underwent a 1-day, 8-dose escalation (e.g., one dose of placebo, 0.14 milliliters [mL], followed by 7 escalating doses of Glycerinated German Cockroach Allergenic Extract until the Maximum Study Dose [0.42 mL, 1:10 wt/vol] or Maximum Tolerated Dose was achieved). This maximum dose became the daily dose - maintenance dose- of Glycerinated German Cockroach Allergenic Extract for the following 14 days.The maintenance dose of 0.42 mL was calculated to contain 3685 bioequivalent allergy units (BAU), with approximately 4.2 mg of German cockroach allergen Bla g 2 and 50 mg of Bla g 1 per dose. Route of administration: sublingual-oral route.
1150549|NCT00434421|P1|Participant Flow|German Cockroach Allergen Dosing Group|Initially each subject underwent a 1-day, 8-dose escalation (e.g., one dose of placebo, 0.14 milliliters [mL], followed by 7 escalating doses of Glycerinated German Cockroach Allergenic Extract until the Maximum Study Dose [0.42 mL, 1:10 wt/vol] or Maximum Tolerated Dose was achieved). This maximum dose became the daily dose - maintenance dose- of Glycerinated German Cockroach Allergenic Extract for the following 14 days.The maintenance dose of 0.42 mL was calculated to contain 3685 bioequivalent allergy units (BAU), with approximately 4.2 mg of German cockroach allergen Bla g 2 and 50 mg of Bla g 1 per dose. Route of administration: sublingual-oral route.
1150550|NCT00434421|O1|Outcome|German Cockroach Allergen Dosing Group|Initially each subject underwent a 1-day, 8-dose escalation (e.g., one dose of placebo, 0.14 milliliters [mL], followed by 7 escalating doses of Glycerinated German Cockroach Allergenic Extract until the Maximum Study Dose [0.42 mL, 1:10 wt/vol] or Maximum Tolerated Dose was achieved). This maximum dose became the daily dose - maintenance dose- of Glycerinated German Cockroach Allergenic Extract for the following 14 days.The maintenance dose of 0.42 mL was calculated to contain 3685 bioequivalent allergy units (BAU), with approximately 4.2 mg of German cockroach allergen Bla g 2 and 50 mg of Bla g 1 per dose. Route of administration: sublingual-oral route.
1150551|NCT00434421|E1|Reported Event|German Cockroach Allergen Dosing Group|Initially each subject underwent a 1-day, 8-dose escalation (e.g., one dose of placebo, 0.14 milliliters [mL], followed by 7 escalating doses of Glycerinated German Cockroach Allergenic Extract until the Maximum Study Dose [0.42 mL, 1:10 wt/vol] or Maximum Tolerated Dose was achieved). This maximum dose became the daily dose - maintenance dose- of Glycerinated German Cockroach Allergenic Extract for the following 14 days.The maintenance dose of 0.42 mL was calculated to contain 3685 bioequivalent allergy units (BAU), with approximately 4.2 mg of German cockroach allergen Bla g 2 and 50 mg of Bla g 1 per dose. Route of administration: sublingual-oral route.
1150552|NCT00434356|B3|Baseline|Total|Total of all reporting groups
1150553|NCT00434356|B2|Baseline|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
1150554|NCT00434356|B1|Baseline|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
1150555|NCT00434356|P2|Participant Flow|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
1150556|NCT00434356|P1|Participant Flow|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
1150557|NCT00434356|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
1150558|NCT00434356|O1|Outcome|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
1150559|NCT00434356|O1|Outcome|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
1150560|NCT00434356|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
1150843|NCT00433914|O2|Outcome|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
1150561|NCT00434356|O1|Outcome|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
1150562|NCT00434356|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
1150563|NCT00434356|O1|Outcome|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
1150564|NCT00434356|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
1150565|NCT00434356|O1|Outcome|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
1150566|NCT00434356|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
1150723|NCT00434161|O1|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy.
1150567|NCT00434356|O1|Outcome|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
1150568|NCT00434356|E2|Reported Event|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
1150569|NCT00434356|E1|Reported Event|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
1150570|NCT00434330|B7|Baseline|Total|Total of all reporting groups
1150571|NCT00434330|B6|Baseline|Cohort 6, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
1150572|NCT00434330|B5|Baseline|Cohort 5, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
1150573|NCT00434330|B4|Baseline|Cohort 4, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
1150574|NCT00434330|B3|Baseline|Cohort 3, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
1150575|NCT00434330|B2|Baseline|Cohort 2, Q4W, IV, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
1150576|NCT00434330|B1|Baseline|Cohort 1, Q4W, SC, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
1150577|NCT00434330|P6|Participant Flow|Cohort 6, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
1150578|NCT00434330|P5|Participant Flow|Cohort 5, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
1150579|NCT00434330|P4|Participant Flow|Cohort 4, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
1150580|NCT00434330|P3|Participant Flow|Cohort 3, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
1151476|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
1150581|NCT00434330|P2|Participant Flow|Cohort 2, Q4W, IV, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
1150582|NCT00434330|P1|Participant Flow|Cohort 1, Q4W, SC, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
1150583|NCT00434330|O6|Outcome|Cohort 6, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
1150584|NCT00434330|O5|Outcome|Cohort 5, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
1150661|NCT00434252|B2|Baseline|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
1150585|NCT00434330|O4|Outcome|Cohort 4, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
1150586|NCT00434330|O3|Outcome|Cohort 3, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
1150587|NCT00434330|O2|Outcome|Cohort 2, Q4W, IV, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
1150588|NCT00434330|O1|Outcome|Cohort 1, Q4W, SC, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
1150589|NCT00434330|O6|Outcome|Cohort 6, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
1150590|NCT00434330|O5|Outcome|Cohort 5, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
1150591|NCT00434330|O4|Outcome|Cohort 4, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
1150592|NCT00434330|O3|Outcome|Cohort 3, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
1150593|NCT00434330|O2|Outcome|Cohort 2, Q4W, IV, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
1150594|NCT00434330|O1|Outcome|Cohort 1, Q4W, SC, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
1150595|NCT00434330|O6|Outcome|Cohort 6, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
1150596|NCT00434330|O5|Outcome|Cohort 5, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
1150844|NCT00433914|O1|Outcome|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
1151477|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
1150597|NCT00434330|O4|Outcome|Cohort 4, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
1150598|NCT00434330|O3|Outcome|Cohort 3, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
1150599|NCT00434330|O2|Outcome|Cohort 2, Q4W, IV, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
1150600|NCT00434330|O1|Outcome|Cohort 1, Q4W, SC, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
1150601|NCT00434330|O6|Outcome|Cohort 6, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
1150724|NCT00434161|O2|Outcome|Palifermin|Subjects to receive Before- and After chemotherapy, and Before chemotherapy only.
1150602|NCT00434330|O5|Outcome|Cohort 5, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
1150603|NCT00434330|O4|Outcome|Cohort 4, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
1150604|NCT00434330|O3|Outcome|Cohort 3, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
1150605|NCT00434330|O2|Outcome|Cohort 2, Q4W, IV, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
1150606|NCT00434330|O1|Outcome|Cohort 1, Q4W, SC, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
1150607|NCT00434330|E6|Reported Event|Cohort 6, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
1150608|NCT00434330|E5|Reported Event|Cohort 5, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
1150609|NCT00434330|E4|Reported Event|Cohort 4, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
1150610|NCT00434330|E3|Reported Event|Cohort 3, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
1150611|NCT00434330|E2|Reported Event|Cohort 2, Q4W, IV, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
1150612|NCT00434330|E1|Reported Event|Cohort 1, Q4W, SC, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
1150676|NCT00434252|O1|Outcome|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
1152002|NCT00430781|B4|Baseline|Total|Total of all reporting groups
1150613|NCT00434304|B1|Baseline|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150614|NCT00434304|P1|Participant Flow|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150615|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150616|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150725|NCT00434161|O1|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy.
1158350|NCT00415493|B3|Baseline|Total|Total of all reporting groups
1150617|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150618|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150619|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150620|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150621|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150622|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150623|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150677|NCT00434252|O2|Outcome|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
1150624|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150625|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150626|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150627|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150662|NCT00434252|B1|Baseline|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
1150726|NCT00434161|O2|Outcome|Palifermin|Subjects to receive Before- and After chemotherapy, and Before chemotherapy only.
1158351|NCT00415493|B2|Baseline|Controls|normal subjects
1150628|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150629|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150630|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150631|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150632|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150633|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150634|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150635|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150636|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150637|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150638|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150663|NCT00434252|P2|Participant Flow|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
1150727|NCT00434161|O1|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy.
1158352|NCT00415493|B1|Baseline|Cases|non-allergic rhinitis subjects
1150639|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150640|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150641|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150642|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150643|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150644|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150645|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150646|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150647|NCT00434304|E2|Reported Event|Ropinirole PR/XR (Taper Phase)|The dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
1150648|NCT00434304|E1|Reported Event|Ropinirole PR/XR (Treatment Phase)|Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 mg as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52.
1150649|NCT00434278|B3|Baseline|Total|Total of all reporting groups
1150650|NCT00434278|B2|Baseline|Dornase Alfa|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
1150651|NCT00434278|B1|Baseline|Placebo|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
1150652|NCT00434278|P2|Participant Flow|Dornase Alfa|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
1150653|NCT00434278|P1|Participant Flow|Placebo|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
1150654|NCT00434278|O2|Outcome|Dornase Alfa|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
1150655|NCT00434278|O1|Outcome|Placebo|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
1150656|NCT00434278|O2|Outcome|Dornase Alfa|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
1150657|NCT00434278|O1|Outcome|Placebo|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
1150658|NCT00434278|E2|Reported Event|Dornase Alfa|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
1150659|NCT00434278|E1|Reported Event|Placebo|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
1150660|NCT00434252|B3|Baseline|Total|Total of all reporting groups
1150686|NCT00434226|P2|Participant Flow|Bevacizumab + Carboplatin/Paclitaxel|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
1150664|NCT00434252|P1|Participant Flow|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
1150665|NCT00434252|O2|Outcome|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
1150666|NCT00434252|O1|Outcome|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
1150667|NCT00434252|O2|Outcome|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
1150668|NCT00434252|O1|Outcome|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
1150669|NCT00434252|O2|Outcome|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
1150670|NCT00434252|O1|Outcome|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
1150671|NCT00434252|O2|Outcome|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
1150672|NCT00434252|O1|Outcome|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
1150673|NCT00434252|O2|Outcome|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
1150674|NCT00434252|O1|Outcome|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
1150675|NCT00434252|O2|Outcome|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
1153171|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
1150678|NCT00434252|O1|Outcome|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
1150679|NCT00434252|O2|Outcome|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
1150680|NCT00434252|O1|Outcome|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
1150681|NCT00434252|E2|Reported Event|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
1150682|NCT00434252|E1|Reported Event|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
1150683|NCT00434226|B3|Baseline|Total|Total of all reporting groups
1150684|NCT00434226|B2|Baseline|Bevacizumab + Carboplatin/Paclitaxel|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
1150685|NCT00434226|B1|Baseline|Bevacizumab + Carboplatin/Paclitaxel + Sunitinib|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
1150687|NCT00434226|P1|Participant Flow|Bevacizumab + Carboplatin/Paclitaxel + Sunitinib|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
1150688|NCT00434226|O2|Outcome|Bevacizumab + Carboplatin/Paclitaxel|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
1150689|NCT00434226|O1|Outcome|Bevacizumab + Carboplatin/Paclitaxel + Sunitinib|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
1150690|NCT00434226|O1|Outcome|Bevacizumab + Carboplatin/Paclitaxel + Sunitinib|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
1150691|NCT00434226|O2|Outcome|Bevacizumab + Carboplatin/Paclitaxel|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
1150692|NCT00434226|O1|Outcome|Bevacizumab + Carboplatin/Paclitaxel + Sunitinib|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
1150693|NCT00434226|O2|Outcome|Bevacizumab + Carboplatin/Paclitaxel|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
1150694|NCT00434226|O1|Outcome|Bevacizumab + Carboplatin/Paclitaxel + Sunitinib|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
1150695|NCT00434226|O2|Outcome|Bevacizumab + Carboplatin/Paclitaxel|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
1150696|NCT00434226|O1|Outcome|Bevacizumab + Carboplatin/Paclitaxel + Sunitinib|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
1150697|NCT00434213|B1|Baseline|Daytrana|Methylphenidate Transdermal System (MTS)
1150698|NCT00434213|P1|Participant Flow|Daytrana|Methylphenidate Transdermal System (MTS)
1150699|NCT00434213|O1|Outcome|Daytrana|Methylphenidate Transdermal System (MTS)
1150700|NCT00434213|O1|Outcome|Daytrana|Methylphenidate Transdermal System (MTS)
1150701|NCT00434213|E1|Reported Event|Daytrana|Methylphenidate Transdermal System (MTS)
1150702|NCT00434161|B4|Baseline|Total|Total of all reporting groups
1150703|NCT00434161|B3|Baseline|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
1150704|NCT00434161|B2|Baseline|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
1150705|NCT00434161|B1|Baseline|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses)
1150706|NCT00434161|P3|Participant Flow|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses). Daily dose of intravenous (IV) 60 µg/kg/day of palifermin as 1 bolus IV injection on Days -6, 5 and -4 before high dose chemotherapy and on Days 0, 1 and 2 after high dose chemotherapy
1150707|NCT00434161|P2|Participant Flow|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy (total of 6 doses). Daily dose of intravenous (IV) 60 µg/kg/day of placebo as 1 bolus IV injection on Days -6, 5 and -4 before high dose chemotherapy and on Days 0, 1 and 2 after high dose chemotherapy.
1150708|NCT00434161|P1|Participant Flow|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses). Daily dose of intravenous (IV) 60 µg/kg/day of palifermin as 1 bolus IV injection on Days -6, 5 and -4 before high dose chemotherapy and placebo on Days 0, 1 and 2 after high dose chemotherapy.
1153172|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
1150710|NCT00434161|O1|Outcome|Palifermin (Palifermin Before Only and, Before and After)|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses) AND Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
1150711|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
1150712|NCT00434161|O1|Outcome|Palifermin (Palifermin Before Only and, Before and After)|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses) AND Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
1150713|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
1150714|NCT00434161|O1|Outcome|Palifermin (Palifermin Before Only and, Before and After)|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses) AND Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
1150715|NCT00434161|O2|Outcome|Palifermin|Subjects to receive Before- and After chemotherapy, and Before chemotherapy only
1150716|NCT00434161|O1|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
1150717|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
1150718|NCT00434161|O1|Outcome|Palifermin (Palifermin Before Only and, Before and After)|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses) AND Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
1150719|NCT00434161|O3|Outcome|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy
1150720|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
1150721|NCT00434161|O1|Outcome|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy and matched placebo after-high dose chemotherapy
1150728|NCT00434161|O2|Outcome|Palifermin|Subjects to receive Before- and After chemotherapy, and Before chemotherapy only.
1150729|NCT00434161|O1|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy.
1150730|NCT00434161|O2|Outcome|Palifermin|Subjects to receive Before- and After chemotherapy, and Before chemotherapy only
1150731|NCT00434161|O1|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
1150732|NCT00434161|O2|Outcome|Palifermin|Subjects to receive Before- and After chemotherapy, and Before chemotherapy only
1150733|NCT00434161|O1|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
1150734|NCT00434161|O3|Outcome|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
1150735|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
1150736|NCT00434161|O1|Outcome|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses)
1150737|NCT00434161|O3|Outcome|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
1150738|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
1150739|NCT00434161|O1|Outcome|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses)
1150740|NCT00434161|O3|Outcome|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
1150741|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
1150742|NCT00434161|O1|Outcome|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses)
1150743|NCT00434161|O3|Outcome|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy
1150744|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
1150745|NCT00434161|O1|Outcome|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy and matched placebo after-high dose chemotherapy
1150746|NCT00434161|E3|Reported Event|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses). A total of 115 subjects were randomized to treatment and 113 received at least one dose of study treatment. Due to protocol deviations additional 4 patients randomized to Palifermin Before and After group were included Palifermin Before Only group and therefore a total of 109 subjects were included in this safety analysis set.
1150747|NCT00434161|E2|Reported Event|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
1150748|NCT00434161|E1|Reported Event|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses). A total of 109 subjects were randomized to treatment and 107 received at least one dose of study treatment. Due to protocol deviations 4 patients randomized to Palifermin Before and After group were included Palifermin Before Only group and therefore a total of 111 subjects were included in this safety analysis set.
1150749|NCT00434148|B3|Baseline|Total|Total of all reporting groups
1150750|NCT00434148|B2|Baseline|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
1150813|NCT00434018|B1|Baseline|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
1151478|NCT00432341|E2|Reported Event|Dysport®|Botulinum toxin type A (Dysport®)
1150751|NCT00434148|B1|Baseline|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
1150752|NCT00434148|P2|Participant Flow|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
1150753|NCT00434148|P1|Participant Flow|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
1150754|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
1150792|NCT00434122|O2|Outcome|Degarelix Follicular, 2.5 mg|Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6
1150755|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
1150756|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
1150757|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
1150758|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
1150759|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
1150760|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
1150761|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
1150891|NCT00433654|P1|Participant Flow|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
1150762|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
1150763|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
1150764|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
1150765|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
1150793|NCT00434122|O1|Outcome|Degarelix Mid-luteal, 2.5 mg|Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.
1150861|NCT00433836|O1|Outcome|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
1150766|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
1150767|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
1150768|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
1150769|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
1150770|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
1150771|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
1150772|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
1150773|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
1150774|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
1150775|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
1150776|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
1150794|NCT00434122|O2|Outcome|Placebo|"Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6.~or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day."
1150777|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
1150778|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
1150779|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
1150780|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
1150781|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
1150782|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
1150783|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
1150784|NCT00434148|E2|Reported Event|Pasireotide 900 ug|At randomization, participants received 900 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
1150785|NCT00434148|E1|Reported Event|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
1150786|NCT00434122|B3|Baseline|Total|Total of all reporting groups
1150787|NCT00434122|B2|Baseline|Placebo|"Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6.~or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day."
1150788|NCT00434122|B1|Baseline|Degarelix Mid-luteal, 2.5 mg|Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.
1150789|NCT00434122|P2|Participant Flow|Placebo|"Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6.~or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day."
1150790|NCT00434122|P1|Participant Flow|Degarelix Mid-luteal, 2.5 mg|Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.
1150791|NCT00434122|O3|Outcome|Ganirelix, 0.25 mg|Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day.
1150795|NCT00434122|O1|Outcome|Degarelix Mid-luteal, 2.5 mg|Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.
1150796|NCT00434122|E2|Reported Event|Ganirelix, 0.25 mg|Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day.
1150797|NCT00434122|E1|Reported Event|Degarelix, 2.5 mg|"Combination of these two groups: Degarelix Mid-luteal 2.5 mg and Degarelix Follicular 2.5 mg.~Degarelix Mid-luteal, 2.5 mg: Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.~Degarelix Follicular, 2.5 mg: Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6."
1150798|NCT00434109|B1|Baseline|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
1150799|NCT00434109|P1|Participant Flow|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
1150800|NCT00434109|O1|Outcome|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
1150801|NCT00434109|O1|Outcome|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
1150802|NCT00434109|O1|Outcome|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
1150803|NCT00434109|O1|Outcome|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
1150804|NCT00434109|O1|Outcome|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
1150805|NCT00434109|O1|Outcome|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
1150806|NCT00434109|E1|Reported Event|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
1150807|NCT00434057|B1|Baseline|Biopsied Pigmented Skin Lesions|Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
1150808|NCT00434057|P1|Participant Flow|Biopsied Pigmented Skin Lesions|Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
1150809|NCT00434057|O1|Outcome|Biopsied Pigmented Skin Lesions|Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
1150810|NCT00434057|E1|Reported Event|Biopsied Pigmented Skin Lesions|Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
1150811|NCT00434018|B3|Baseline|Total|Total of all reporting groups
1150812|NCT00434018|B2|Baseline|Basic Health Education|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
1150842|NCT00433914|O1|Outcome|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
1150814|NCT00434018|P2|Participant Flow|Basic Health Education|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
1150815|NCT00434018|P1|Participant Flow|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
1150816|NCT00434018|O2|Outcome|Basic Health Training|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
1150817|NCT00434018|O1|Outcome|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
1150818|NCT00434018|O2|Outcome|Basic Health Training|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
1150819|NCT00434018|O1|Outcome|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
1150820|NCT00434018|O2|Outcome|Basic Health Training|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
1150821|NCT00434018|O1|Outcome|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
1150860|NCT00433836|O2|Outcome|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
1161116|NCT00409344|O1|Outcome|Saline|This group will recive saline
1150822|NCT00434018|O2|Outcome|Basic Health Training|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
1150823|NCT00434018|O1|Outcome|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
1150824|NCT00434018|O2|Outcome|Basic Health Training|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
1150825|NCT00434018|O1|Outcome|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
1150826|NCT00434018|O2|Outcome|Basic Health Education|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
1150827|NCT00434018|O1|Outcome|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
1150828|NCT00434018|E2|Reported Event|Basic Health Education|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
1150829|NCT00434018|E1|Reported Event|Wheelchair Skills Training|Wheelchair Skills Training: Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs.
1150830|NCT00433914|B3|Baseline|Total|Total of all reporting groups
1150831|NCT00433914|B2|Baseline|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
1150832|NCT00433914|B1|Baseline|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
1150833|NCT00433914|P2|Participant Flow|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
1150834|NCT00433914|P1|Participant Flow|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
1150835|NCT00433914|O2|Outcome|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
1150836|NCT00433914|O1|Outcome|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
1150837|NCT00433914|O2|Outcome|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
1150838|NCT00433914|O1|Outcome|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
1150839|NCT00433914|O2|Outcome|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
1150840|NCT00433914|O1|Outcome|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
1150841|NCT00433914|O2|Outcome|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
1150892|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI scan) at 9-12 weeks post-implant
1150845|NCT00433914|O2|Outcome|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
1150846|NCT00433914|O1|Outcome|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
1150847|NCT00433914|O2|Outcome|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
1150848|NCT00433914|O1|Outcome|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
1150849|NCT00433914|E2|Reported Event|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
1150850|NCT00433914|E1|Reported Event|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
1150851|NCT00433836|B3|Baseline|Total|Total of all reporting groups
1150852|NCT00433836|B2|Baseline|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
1150853|NCT00433836|B1|Baseline|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
1150854|NCT00433836|P2|Participant Flow|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
1150855|NCT00433836|P1|Participant Flow|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
1150856|NCT00433836|O2|Outcome|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
1150857|NCT00433836|O1|Outcome|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
1150858|NCT00433836|O2|Outcome|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
1150859|NCT00433836|O1|Outcome|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
1150862|NCT00433836|O2|Outcome|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
1150863|NCT00433836|O1|Outcome|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
1150864|NCT00433836|E2|Reported Event|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
1150865|NCT00433836|E1|Reported Event|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
1150866|NCT00433771|B1|Baseline|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
1150867|NCT00433771|P1|Participant Flow|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
1150868|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
1150869|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
1150870|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
1150871|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
1150872|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
1150873|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
1150874|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
1150875|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
1150876|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
1150877|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
1150878|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
1150879|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
1150880|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
1150881|NCT00433771|E1|Reported Event|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
1150882|NCT00433745|B1|Baseline|WT1 Peptide Vaccine|Subjects with hematologic malignancies will receive WT1 peptide vaccine to evaluate if the intervention will stimulate a protective immune response.
1150883|NCT00433745|P1|Participant Flow|WT1 Peptide Vaccine|Subjects with hematologic malignancies will receive WT1 peptide vaccine to evaluate if the intervention will stimulate a protective immune response.
1150884|NCT00433745|O1|Outcome|WT1 Peptide Vaccine|"All 4 patients who were accrued went on to receive the vaccine.~Complete Response (CR): defined as an absolute neutrophil count of ≥500/µL, platelet count of ≥75,000/µL, no leukemic blasts in the blood nor evidence of extramedullary leukemia, bone marrow (BM) with a cellularity of more than 20%, maturation of all three cell lineages, no Auer rods, and less than 5% bone marrow blast cells.~Partial response (PR): 50% reduction in marrow blasts, with an absolute neutrophil count (ANC) greater than 500/µL, and platelet count greater than 75000/µL.~No response: subjects who did not meet the above response criteria were defined as non-responders."
1150885|NCT00433745|O1|Outcome|WT1 Peptide Vaccine|Subjects with hematologic malignancies will receive WT1 peptide vaccine to evaluate if the intervention will stimulate a protective immune response.
1150886|NCT00433745|E1|Reported Event|WT1 Peptide Vaccine|All 4 patients who were accrued went on to receive the vaccine
1150887|NCT00433654|B3|Baseline|Total|Total of all reporting groups
1150888|NCT00433654|B2|Baseline|Control Group|The control group waited for one hour (did not have an MRI scan) at 9-12 weeks post-implant.
1150889|NCT00433654|B1|Baseline|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
1150890|NCT00433654|P2|Participant Flow|Control Group|The control group waited for one hour (no MRI scan) at 9-12 weeks post-implant
1151479|NCT00432341|E1|Reported Event|BOTOX®|Botulinum toxin type A (BOTOX®)
1150893|NCT00433654|O1|Outcome|5086 MRI Lead|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
1150894|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI scan) at the 9-12 week follow-up.
1150895|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
1150896|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI) at the 9-12 week follow-up.
1150897|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
1150898|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI scan) at the 9-12 week follow-up.
1150899|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
1150900|NCT00433654|O1|Outcome|5086 MRI Lead|The 5086 MRI lead was used by all subjects in this study
1150901|NCT00433654|O1|Outcome|5086 MRI Lead|The 5086 MRI lead was used by all subjects in this study
1150902|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI scan) at 9-12 weeks post-implant
1150903|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
1150904|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI) at the 9-12 week follow-up.
1150905|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
1150906|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
1150907|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
1150908|NCT00433654|O1|Outcome|Implanted Subjects|All subjects undergoing an implant attempt
1150909|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI) at the 9-12 week follow-up.
1150910|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
1150911|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI scan) at the 9-12 week follow-up.
1150912|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
1150913|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI scan) at 9-12 weeks post-implant
1150914|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
1150915|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI) at the 9-12 week follow-up.
1150916|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
1150917|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
1150918|NCT00433654|E3|Reported Event|Non-randomized|Some subjects were enrolled, but either did not receive a system, or received only a partial system, and were not randomized. Their adverse events were collected until they exited the study.
1150919|NCT00433654|E2|Reported Event|Control Group|The control group waited for one hour (no MRI scan) at 9-12 weeks post-implant
1150920|NCT00433654|E1|Reported Event|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
1150921|NCT00433537|B1|Baseline|Step 1 - VcR-CVAD Induction|All eligible patients who received VcR-CVAD induction.
1150922|NCT00433537|P3|Participant Flow|VcR-CVAD Induction Then Off Study|Patients received VcR-CVAD induction but did not proceed to step 2 treatment for various reasons.
1150923|NCT00433537|P2|Participant Flow|VcR-CVAD Induction Followed by ASCT|"VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) SC or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ASCT: After completion of induction therapy, patients who are eligible may have the option to receive consolidation therapy for autologous stem cell transplantation (off-study). These patients undergo stem cell harvest during courses 4, 5, or 6 of induction therapy."
1150924|NCT00433537|P1|Participant Flow|VcR-CVAD Induction Followed by Maintenance Rituximab|"VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) subcutaneous (SC) or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Maintenance rituximab: Beginning 4-8 weeks after completion of induction therapy, patients receive rituximab IV over 3-4 hours once weekly for 4 weeks. Treatment repeats every 6 months for up to 4 courses in the absence of disease progression or unacceptable toxicity."
1150925|NCT00433537|O2|Outcome|VcR-CVAD Induction Followed by ASCT|"VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) SC or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ASCT: After completion of induction therapy, patients who are eligible may have the option to receive consolidation therapy for autologous stem cell transplantation (off-study). These patients undergo stem cell harvest during courses 4, 5, or 6 of induction therapy."
1150947|NCT00433381|E2|Reported Event|Arm II (Bevacizumab and Irinotecan Hydrochloride)|Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor. Data is reported for eligible patients with adverse event data who started study treatment, which is 57 patients.
1151480|NCT00432276|B3|Baseline|Total|Total of all reporting groups
1150926|NCT00433537|O1|Outcome|VcR-CVAD Induction Followed by Maintenance Rituximab|"VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) SC or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Maintenance rituximab: Beginning 4-8 weeks after completion of induction therapy, patients receive rituximab IV over 3-4 hours once weekly for 4 weeks. Treatment repeats every 6 months for up to 4 courses in the absence of disease progression or unacceptable toxicity."
1150927|NCT00433537|O2|Outcome|VcR-CVAD Induction Followed by ASCT|"VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) SC or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ASCT: After completion of induction therapy, patients who are eligible may have the option to receive consolidation therapy for autologous stem cell transplantation (off-study). These patients undergo stem cell harvest during courses 4, 5, or 6 of induction therapy."
1150958|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1150959|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1151042|NCT00433199|E2|Reported Event|T-Gel 1.62%|Testosterone (T): daily dose of 2.50 g testosterone gel 1.62% administered during the Double-Blind period and the Open-Label period.
1150928|NCT00433537|O1|Outcome|VcR-CVAD Induction Followed by Maintenance Rituximab|"VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) SC or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Maintenance rituximab: Beginning 4-8 weeks after completion of induction therapy, patients receive rituximab IV over 3-4 hours once weekly for 4 weeks. Treatment repeats every 6 months for up to 4 courses in the absence of disease progression or unacceptable toxicity."
1150929|NCT00433537|O1|Outcome|VcR-CVAD Induction|All eligible patients who received VcR-CVAD induction.
1150930|NCT00433537|E2|Reported Event|Step 2 - Maintenance Rituximab|All patients who received maintenance rituximab.
1150931|NCT00433537|E1|Reported Event|Step 1 - VcR-CVAD Induction|All patients who received VcR-CVAD induction.
1150932|NCT00433446|B1|Baseline|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
1150933|NCT00433446|P1|Participant Flow|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
1150934|NCT00433446|O1|Outcome|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
1150935|NCT00433446|O1|Outcome|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
1150936|NCT00433446|O1|Outcome|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
1150937|NCT00433446|O1|Outcome|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
1150938|NCT00433446|O1|Outcome|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
1150939|NCT00433446|E1|Reported Event|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
1150940|NCT00433381|B3|Baseline|Total|Total of all reporting groups
1150941|NCT00433381|B2|Baseline|Arm II (Bevacizumab and Irinotecan Hydrochloride)|Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
1150942|NCT00433381|B1|Baseline|Arm I (Bevacizumab and Temozolomide)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral temozolomide once daily on days 1-21 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
1150943|NCT00433381|P2|Participant Flow|Arm II (Bevacizumab and Irinotecan Hydrochloride)|Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
1150944|NCT00433381|P1|Participant Flow|Arm I (Bevacizumab and Temozolomide)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral temozolomide once daily on days 1-21 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
1150945|NCT00433381|O1|Outcome|Arm I (Bevacizumab and Temozolomide)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral temozolomide once daily on days 1-21 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
1150946|NCT00433381|O1|Outcome|Arm II (Bevacizumab and Irinotecan Hydrochloride)|Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as definted by stable or responding tumor.
1151024|NCT00433199|B2|Baseline|T-Gel 1.62%|Testosterone (T): daily dose of 2.50 g testosterone gel 1.62% administered during the Double-Blind period and the Open-Label period.
1153173|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
1150948|NCT00433381|E1|Reported Event|Arm I (Bevacizumab and Temozolomide)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral temozolomide once daily on days 1-21 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor. Data is reported for eligible patients with adverse event data who started study treatment, which is 60.
1150949|NCT00433329|B1|Baseline|Bosentan/Sildenafil|Oral bosentan 62.5 mg twice daily (BID) for 4 week followed by 24 weeks of 125 mg BID with the addition of sildenafil 20 mg thrice daily (TID) in patients who do not reach the 6-MWT distance threshold at Week 16
1150950|NCT00433329|P1|Participant Flow|Bosentan/Sildenafil|Oral bosentan 62.5 mg twice daily (BID) for 4 week followed by 24 weeks of 125 mg BID with the addition of sildenafil 20 mg thrice daily (TID) in patients who do not reach the 6-MWT distance threshold at Week 16
1150951|NCT00433329|O1|Outcome|Bosentan/Sildenafil|Oral bosentan 62.5 mg twice daily (BID) for 4 week followed by 24 weeks of 125 mg BID with the addition of sildenafil 20 mg thrice daily (TID) in patients who do not reach the 6-MWT distance threshold at Week 16
1150952|NCT00433329|E1|Reported Event|Bosentan/Sildenafil|Oral bosentan 62.5 mg twice daily (BID) for 4 week followed by 24 weeks of 125 mg BID with the addition of sildenafil 20 mg thrice daily (TID) in patients who do not reach the 6-MWT distance threshold at Week 16
1150953|NCT00433290|B3|Baseline|Total|Total of all reporting groups
1150954|NCT00433290|B2|Baseline|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
1150955|NCT00433290|B1|Baseline|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1150956|NCT00433290|P2|Participant Flow|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
1150957|NCT00433290|P1|Participant Flow|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1150960|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1150961|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
1150962|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1150963|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
1150964|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1150965|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
1150966|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1150967|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
1150968|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1150969|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
1150970|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1150971|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
1150972|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1150973|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
1150974|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1150975|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
1150976|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1150977|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
1150978|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1150979|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
1150980|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1150981|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
1150982|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1150983|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
1150984|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1150985|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
1151025|NCT00433199|B1|Baseline|Placebo|Placebo comparator administered during the Double-Blind period only
1150986|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1150987|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
1150988|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1150989|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
1150990|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1150991|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
1150992|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1150993|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
1150994|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1150995|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
1150996|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1150997|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
1151041|NCT00433199|O1|Outcome|T-Gel 1.62%|Testosterone gel 1.62% given during the double-blind period.
1152782|NCT00428974|E3|Reported Event|CF101 4 mg BID|Oral tablets given every 12 hours for 12 weeks
1150998|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1150999|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
1151000|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1151001|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
1151002|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1151003|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
1151004|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1151005|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
1151006|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1151007|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
1151008|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1151009|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
1151010|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1151011|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
1151012|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1151013|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
1151014|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1151015|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
1151016|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1151017|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
1151018|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1151019|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
1151020|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1151021|NCT00433290|E2|Reported Event|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
1151022|NCT00433290|E1|Reported Event|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
1151023|NCT00433199|B3|Baseline|Total|Total of all reporting groups
1151026|NCT00433199|P2|Participant Flow|T-Gel 1.62%|Testosterone (T): daily dose of 2.50 g testosterone gel 1.62% administered during the Double-Blind period and the Open-Label period.
1151027|NCT00433199|P1|Participant Flow|Placebo|Placebo comparator administered during the Double-Blind period only
1151028|NCT00433199|O3|Outcome|Combined (CA and FP)|Testosterone gel 1.62% is given to all the subjects entering the Open-label period.
1151029|NCT00433199|O2|Outcome|Formerly Placebo (FP)|Placebo given during the Double-blind period and Testosterone gel 1.62% given during the Open-label period.
1151030|NCT00433199|O1|Outcome|Continuing Active T-Gel 1.62% (CA)|Testosterone gel 1.62% given during the Double-blind period and Testosterone gel 1.62% given during the Open-label period.
1151031|NCT00433199|O3|Outcome|Combined (CA and FP)|Testosterone gel 1.62% is given to all the subjects entering the Open-label period.
1151032|NCT00433199|O2|Outcome|Formerly Placebo (FP)|Placebo group given during the Double-Blind period and Testosterone gel 1.62% given during the Open-label period.
1151033|NCT00433199|O1|Outcome|Continuing Active T-Gel 1.62% (CA)|Testosterone gel 1.62% given during the Double-Blind period and Testosterone gel 1.62% given during the Open-label period.
1151034|NCT00433199|O2|Outcome|Placebo|Placebo Comparator given during the double-blind period.
1151035|NCT00433199|O1|Outcome|T-Gel 1.62%|Testosterone gel 1.62% given during the double-blind period.
1151036|NCT00433199|O2|Outcome|Placebo|Placebo Comparator given during the double-blind period.
1151037|NCT00433199|O1|Outcome|T-Gel 1.62%|Testosterone gel 1.62% given during the double-blind period.
1151038|NCT00433199|O2|Outcome|Placebo|Placebo Comparator given during the double-blind period.
1151039|NCT00433199|O1|Outcome|T-Gel 1.62%|Testosterone gel 1.62% given during the double-blind period.
1151040|NCT00433199|O2|Outcome|Placebo|Placebo Comparator given during the double-blind period.
1151043|NCT00433199|E1|Reported Event|Placebo|Placebo comparator administered during the Double-Blind period only
1151044|NCT00433160|B3|Baseline|Total|Total of all reporting groups
1151045|NCT00433160|B2|Baseline|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
1151046|NCT00433160|B1|Baseline|Teriparatide|20 micrograms for 104 weeks
1151047|NCT00433160|P2|Participant Flow|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
1151048|NCT00433160|P1|Participant Flow|Teriparatide|20 micrograms for 104 weeks
1151049|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
1151050|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
1151051|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
1151052|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
1151053|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
1151054|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
1151055|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
1151056|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
1151057|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
1151058|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
1151059|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
1151060|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
1151061|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
1151062|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
1151063|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
1151064|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
1151065|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
1151066|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
1151067|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
1151068|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
1151069|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
1151070|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
1151071|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
1151072|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
1151073|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
1151074|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
1151075|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
1151076|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
1151077|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
1151078|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
1151079|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
1151080|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
1151081|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
1151082|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
1151083|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
1151085|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
1151086|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
1151087|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
1151088|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
1151089|NCT00433160|E6|Reported Event|Placebo (During 104 Weeks)|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
1151090|NCT00433160|E5|Reported Event|Teriparatide (During 104 Weeks)|20 micrograms for 104 weeks
1151091|NCT00433160|E4|Reported Event|Placebo (During 76 Weeks)|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
1151092|NCT00433160|E3|Reported Event|Teriparatide (During 76 Weeks)|20 micrograms for 104 weeks
1151093|NCT00433160|E2|Reported Event|Placebo (During 52 Weeks)|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
1151094|NCT00433160|E1|Reported Event|Teriparatide (During 52 Weeks)|20 micrograms for 104 weeks
1151095|NCT00433017|B3|Baseline|Total|Total of all reporting groups
1151128|NCT00432835|P2|Participant Flow|Gastric StimulationNotActivated Days1-4/Activated Days5-8|The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal EGG, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours.
1151169|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
1151096|NCT00433017|B2|Baseline|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
1151097|NCT00433017|B1|Baseline|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
1151098|NCT00433017|P2|Participant Flow|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
1151099|NCT00433017|P1|Participant Flow|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
1151100|NCT00433017|O2|Outcome|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
1151101|NCT00433017|O1|Outcome|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
1151102|NCT00433017|O2|Outcome|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
1151117|NCT00432991|O2|Outcome|IM Ephedrine|"IM Ephedrine~Ephedrine [Synonyms: Ephedra, Ephedrinum]: 25 mg, IM (in the muscle), one time"
1151103|NCT00433017|O1|Outcome|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
1151104|NCT00433017|O2|Outcome|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
1151105|NCT00433017|O1|Outcome|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
1162431|NCT00406107|B3|Baseline|Total|Total of all reporting groups
1151106|NCT00433017|O2|Outcome|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
1151107|NCT00433017|O1|Outcome|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
1151108|NCT00433017|O2|Outcome|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
1151109|NCT00433017|O1|Outcome|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
1151110|NCT00433017|E2|Reported Event|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
1151111|NCT00433017|E1|Reported Event|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
1151112|NCT00432991|B3|Baseline|Total|Total of all reporting groups
1151113|NCT00432991|B2|Baseline|IM Ephedrine|"IM Ephedrine~Ephedrine [Synonyms: Ephedra, Ephedrinum]: 25 mg, IM (in the muscle), one time"
1151114|NCT00432991|B1|Baseline|Saline Placebo|Saline Placebo: 0.5 mL, IM (in the muscle), one time
1151115|NCT00432991|P2|Participant Flow|IM Ephedrine|"IM Ephedrine~Ephedrine [Synonyms: Ephedra, Ephedrinum]: 25 mg, IM (in the muscle), one time"
1151116|NCT00432991|P1|Participant Flow|Saline Placebo|Saline Placebo: 0.5 mL, IM (in the muscle), one time
1151118|NCT00432991|O1|Outcome|Saline Placebo|Saline Placebo: 0.5 mL, IM (in the muscle), one time
1151119|NCT00432991|O2|Outcome|IM Ephedrine|"IM Ephedrine~Ephedrine [Synonyms: Ephedra, Ephedrinum]: 25 mg, IM (in the muscle), one time"
1151120|NCT00432991|O1|Outcome|Saline Placebo|Saline Placebo: 0.5 mL, IM (in the muscle), one time
1151121|NCT00432991|O2|Outcome|IM Ephedrine|"IM Ephedrine~Ephedrine [Synonyms: Ephedra, Ephedrinum]: 25 mg, IM (in the muscle), one time"
1151122|NCT00432991|O1|Outcome|Saline Placebo|Saline Placebo: 0.5 mL, IM (in the muscle), one time
1151123|NCT00432991|E2|Reported Event|IM Ephedrine|"IM Ephedrine~Ephedrine [Synonyms: Ephedra, Ephedrinum]: 25 mg, IM (in the muscle), one time"
1151124|NCT00432991|E1|Reported Event|Saline Placebo|Saline Placebo: 0.5 mL, IM (in the muscle), one time
1151125|NCT00432835|B3|Baseline|Total|Total of all reporting groups
1151126|NCT00432835|B2|Baseline|Gastric StimulationNotActivated Days1-4/Activated Days5-8|The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal EGG, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours.
1151127|NCT00432835|B1|Baseline|Gastric Stimactivated Days1-4/Not Activated Days5-8|The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal Electrogastrogram, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days
1151166|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
1151167|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
1151129|NCT00432835|P1|Participant Flow|Gastric Stimactivated Days1-4/Not Activated Days5-8|The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal Electrogastrogram, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days
1151130|NCT00432835|O2|Outcome|Gastric StimulationNotActivated Days1-4/Activated Days5-8|The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal electrogastrogram, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours.
1151131|NCT00432835|O1|Outcome|Gastric Stimactivated Days1-4/Not Activated Days5-8|The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal Electrogastrogram, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days
1151132|NCT00432835|O2|Outcome|Gastric StimulationNotActivated Days1-4/Activated Days5-8|The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal electrogastrogram, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours.
1151133|NCT00432835|O1|Outcome|Gastric Stimactivated Days1-4/Not Activated Days5-8|The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal Electrogastrogram, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days
1151134|NCT00432835|O2|Outcome|Gastric StimulationNotActivated Days1-4/Activated Days5-8|The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal electrogastrogram, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours.
1151135|NCT00432835|O1|Outcome|Gastric Stimactivated Days1-4/Not Activated Days5-8|The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal Electrogastrogram, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days
1151136|NCT00432835|E2|Reported Event|Gastric StimulationNotActivated|Sham stimulation
1151137|NCT00432835|E1|Reported Event|Gastric Stimactivated|Gastric Electrical Stimulation
1151138|NCT00432809|B4|Baseline|Total|Total of all reporting groups
1151139|NCT00432809|B3|Baseline|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
1151140|NCT00432809|B2|Baseline|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
1151141|NCT00432809|B1|Baseline|Medical Therapy|Intensive medical therapy for diabetes
1151142|NCT00432809|P3|Participant Flow|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
1151143|NCT00432809|P2|Participant Flow|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
1151144|NCT00432809|P1|Participant Flow|Medical Therapy|Intensive medical therapy for diabetes
1151145|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
1151146|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
1151147|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
1151148|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
1151149|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
1151150|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
1151151|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
1151152|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
1151153|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
1151154|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
1151155|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
1151156|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
1151157|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
1151158|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
1151159|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
1151160|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
1151161|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
1151162|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
1151163|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
1151164|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
1151165|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
1151170|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
1151171|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
1151172|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
1151173|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
1151174|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
1151175|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
1151176|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
1151177|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
1151178|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
1151179|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
1151180|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
1151181|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
1151182|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
1151183|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
1151184|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
1151185|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
1151186|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
1151187|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
1151188|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
1151189|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
1151190|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
1151191|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
1151192|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
1151193|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
1151194|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
1151195|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
1151196|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
1151197|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
1151198|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
1151199|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
1151200|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
1151201|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
1151202|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
1151203|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
1151204|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
1151205|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
1153174|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
1151206|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
1151207|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
1151208|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
1151209|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
1151210|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
1151211|NCT00432809|E3|Reported Event|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
1151212|NCT00432809|E2|Reported Event|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
1151213|NCT00432809|E1|Reported Event|Medical Therapy|Intensive medical therapy for diabetes
1151214|NCT00432744|B3|Baseline|Total|Total of all reporting groups
1151215|NCT00432744|B2|Baseline|CoenzymeQ10 Frist|"Patients will be randomized to receive CoenzymeQ10 in Period #1 (Months 0-6) and Placebo given in Period #2( Months 7-12.)~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed.~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group."
1151237|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151786|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
1151216|NCT00432744|B1|Baseline|Placebo First|"Patients will be randomized to receive Placebo in Period #1 (Months 0-6) and CoenzymeQ10 given in Period #2( Months 7-12.)~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group.~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed."
1151217|NCT00432744|P2|Participant Flow|CoenzymeQ10 Frist|"Patients will be randomized to receive CoenzymeQ10 in Period #1 (Months 0-6) and Placebo given in Period #2( Months 7-12.)~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed.~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group."
1151218|NCT00432744|P1|Participant Flow|Placebo First|"Patients will be randomized to receive Placebo in Period #1 (Months 0-6) and CoenzymeQ10 given in Period #2( Months 7-12.)~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group.~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed."
1151219|NCT00432744|O2|Outcome|CoenzymeQ10 Frist|"Patients will be randomized to receive CoenzymeQ10 in Period #1 (Months 0-6) and Placebo given in Period #2( Months 7-12.)~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed.~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group."
1151220|NCT00432744|O1|Outcome|Placebo First|"Patients will be randomized to receive Placebo in Period #1 (Months 0-6) and CoenzymeQ10 given in Period #2( Months 7-12.)~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group.~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed."
1151221|NCT00432744|O2|Outcome|CoenzymeQ10 Frist|"Patients will be randomized to receive CoenzymeQ10 in Period #1 (Months 0-6) and Placebo given in Period #2( Months 7-12.)~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed.~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group."
1151222|NCT00432744|O1|Outcome|Placebo First|"Patients will be randomized to receive Placebo in Period #1 (Months 0-6) and CoenzymeQ10 given in Period #2( Months 7-12.)~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group.~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed."
1151223|NCT00432744|O2|Outcome|CoenzymeQ10 Frist|"Patients will be randomized to receive CoenzymeQ10 in Period #1 (Months 0-6) and Placebo given in Period #2( Months 7-12.)~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed.~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group."
1151224|NCT00432744|O1|Outcome|Placebo First|"Patients will be randomized to receive Placebo in Period #1 (Months 0-6) and CoenzymeQ10 given in Period #2( Months 7-12.)~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group.~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed."
1151225|NCT00432744|E2|Reported Event|Placebo|Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group. (Either in Period 1 or Period 2)
1151226|NCT00432744|E1|Reported Event|CoenzymeQ10|CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed. (Either in Period 1 or Period 2)
1151227|NCT00432666|B3|Baseline|Total|Total of all reporting groups
1151228|NCT00432666|B2|Baseline|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1153175|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
1151229|NCT00432666|B1|Baseline|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151230|NCT00432666|P2|Participant Flow|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151231|NCT00432666|P1|Participant Flow|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151232|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151233|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151234|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151235|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151236|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151787|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
1151238|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151239|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151240|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151241|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151242|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151243|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151244|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151245|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151246|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151247|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151248|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151249|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151250|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151251|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151252|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151253|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151254|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151255|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151256|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151257|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151287|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151258|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151259|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151260|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151261|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151262|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151263|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151264|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151265|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151266|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1152783|NCT00428974|E2|Reported Event|CF101 2 mg BID|Oral tablets given every 12 hours for 12 weeks
1151267|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151268|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151269|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151270|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151271|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151272|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151273|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151274|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151275|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151276|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151277|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151278|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151279|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151280|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151281|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151282|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151283|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151284|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151285|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151286|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151288|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151289|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151290|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151291|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151292|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151293|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151294|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151295|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151788|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
1151296|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151297|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151298|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151299|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151300|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151301|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151302|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151303|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151304|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151305|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151306|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151307|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151308|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151309|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151310|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151311|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151312|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151313|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151314|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151315|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151345|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151316|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151317|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151318|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151319|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151320|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151321|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151322|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151323|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151324|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1154189|NCT00424645|P2|Participant Flow|Placebo|Placebo administered IV following Voraxaze arm.
1151325|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151326|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151327|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151328|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151329|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151330|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151331|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151332|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151333|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151334|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151335|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151336|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151337|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151338|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151339|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151340|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151341|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151342|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151343|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151344|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151346|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151347|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151348|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151349|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151350|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151351|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151352|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151353|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151919|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
1151354|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151355|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151356|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151357|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151358|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151359|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151360|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151361|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151362|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151363|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151364|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151365|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151366|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151367|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151368|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151369|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151370|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151371|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151372|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151373|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151462|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
1151463|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
1151374|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151375|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151376|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151377|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151378|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151379|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151380|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151381|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151382|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1154337|NCT00424619|B4|Baseline|Total|Total of all reporting groups
1151383|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151384|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151385|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151386|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151387|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151388|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151389|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151390|NCT00432666|E2|Reported Event|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1151391|NCT00432666|E1|Reported Event|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1151392|NCT00432601|B3|Baseline|Total|Total of all reporting groups
1151393|NCT00432601|B2|Baseline|Arm 2|"Patients will receive National Comprehensive Cancer Network decision aid.~type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
1151394|NCT00432601|B1|Baseline|Arm 1|"Patients will receive Michigan Cancer Consortium decision aid.~type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
1151395|NCT00432601|P2|Participant Flow|Arm 2 - NCCN|"Patients will receive National Comprehensive Cancer Network decision aid.~type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
1151396|NCT00432601|P1|Participant Flow|Arm 1 - MCC|"Patients will receive Michigan Cancer Consortium decision aid.~type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
1151397|NCT00432601|O2|Outcome|Arm 2 - NCCN|"Patients will receive National Comprehensive Cancer Network decision aid.~type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
1151398|NCT00432601|O1|Outcome|Arm 1 - MCC|"Patients will receive Michigan Cancer Consortium decision aid.~type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
1151399|NCT00432601|E2|Reported Event|Arm 2 - NCCN|"Patients will receive National Comprehensive Cancer Network decision aid.~type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
1151400|NCT00432601|E1|Reported Event|Arm 1 - MCC|"Patients will receive Michigan Cancer Consortium decision aid.~type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
1151401|NCT00432562|B3|Baseline|Total|Total of all reporting groups
1151402|NCT00432562|B2|Baseline|Navelbine/ANX-530|Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of Navelbine in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of ANX-530 in the second study period.
1151464|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
1151403|NCT00432562|B1|Baseline|ANX-530/Navelbine|Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of ANX 530 in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of Navelbine in the second study period.
1151404|NCT00432562|P2|Participant Flow|Navelbine/ANX-530|Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of Navelbine in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of ANX-530 in the second study period.
1151405|NCT00432562|P1|Participant Flow|ANX-530/Navelbine|Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of ANX 530 in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of Navelbine in the second study period.
1151406|NCT00432562|O2|Outcome|Navelbine|
1151407|NCT00432562|O1|Outcome|ANX-530|
1151408|NCT00432562|O2|Outcome|Navelbine|
1151409|NCT00432562|O1|Outcome|ANX-530|
1151410|NCT00432562|O2|Outcome|Navelbine|
1151411|NCT00432562|O1|Outcome|ANX-530|
1151412|NCT00432562|O2|Outcome|Navelbine|
1151413|NCT00432562|O1|Outcome|ANX-530|
1151414|NCT00432562|O2|Outcome|Navelbine|
1151415|NCT00432562|O1|Outcome|ANX-530|
1151416|NCT00432562|O2|Outcome|Navelbine|
1151417|NCT00432562|O1|Outcome|ANX-530|
1151418|NCT00432562|O2|Outcome|Navelbine|
1151419|NCT00432562|O1|Outcome|ANX-530|
1151420|NCT00432562|O2|Outcome|Navelbine|
1151421|NCT00432562|O1|Outcome|ANX-530|
1151422|NCT00432562|O2|Outcome|Navelbine|
1151423|NCT00432562|O1|Outcome|ANX-530|
1151424|NCT00432562|O2|Outcome|Navelbine|
1151425|NCT00432562|O1|Outcome|ANX-530|
1151483|NCT00432276|P2|Participant Flow|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151426|NCT00432562|E2|Reported Event|Navelbine/ANX-530|Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of Navelbine in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of ANX-530. Serious Adverse Events are reported by treatment-sequence group and not by study therapy group.
1151427|NCT00432562|E1|Reported Event|ANX-530/Navelbine|Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of ANX 530 in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of Navelbine. Serious Adverse Events are reported by treatment-sequence group and not by study therapy group.
1151428|NCT00432458|B3|Baseline|Total|Total of all reporting groups
1151429|NCT00432458|B2|Baseline|Arm II: ZLD|Zoledronic acid (ZLD)
1151430|NCT00432458|B1|Baseline|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
1151431|NCT00432458|P2|Participant Flow|Arm II: ZLD|Zoledronic acid (ZLD)
1151432|NCT00432458|P1|Participant Flow|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
1151433|NCT00432458|O2|Outcome|Arm II: ZLD|Zoledronic acid (ZLD)
1151434|NCT00432458|O1|Outcome|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
1151435|NCT00432458|O2|Outcome|Arm II: ZLD|Zoledronic acid (ZLD)
1151436|NCT00432458|O1|Outcome|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
1151437|NCT00432458|O2|Outcome|Arm II: ZLD|Zoledronic acid (ZLD)
1151438|NCT00432458|O1|Outcome|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
1151439|NCT00432458|O2|Outcome|Arm II: ZLD|Zoledronic acid (ZLD)
1151440|NCT00432458|O1|Outcome|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
1151441|NCT00432458|O2|Outcome|Arm II: ZLD|Zoledronic acid (ZLD)
1151442|NCT00432458|O1|Outcome|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
1151443|NCT00432458|O2|Outcome|Arm II: ZLD|Zoledronic acid (ZLD)
1151444|NCT00432458|O1|Outcome|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
1151445|NCT00432458|O2|Outcome|Arm II: ZLD|Zoledronic acid (ZLD)
1151446|NCT00432458|O1|Outcome|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
1151447|NCT00432458|E2|Reported Event|Arm II: ZLD|Zoledronic acid (ZLD)
1151448|NCT00432458|E1|Reported Event|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
1151449|NCT00432445|B1|Baseline|Proton Beam Radiation Therapy|Proton Beam Radiation Therapy given daily for 5 days in a row each week where whole treatment takes about 4-6 weeks. Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary).
1151450|NCT00432445|P1|Participant Flow|Proton Beam Radiation Therapy|Proton Beam Radiation Therapy given daily for 5 days in a row each week where whole treatment takes about 4-6 weeks. Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary).
1151451|NCT00432445|O1|Outcome|Proton Beam Radiation Therapy|Proton Beam Radiation Therapy given daily for 5 days in a row each week where whole treatment takes about 4-6 weeks. Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary).
1151452|NCT00432445|E1|Reported Event|Proton Beam Radiation Therapy|Proton Beam Radiation Therapy given daily for 5 days in a row each week where whole treatment takes about 4-6 weeks. Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary).
1151453|NCT00432341|B3|Baseline|Total|Total of all reporting groups
1151454|NCT00432341|B2|Baseline|Dysport®|Botulinum toxin type A (Dysport®)
1151455|NCT00432341|B1|Baseline|BOTOX®|Botulinum toxin type A (BOTOX®)
1151456|NCT00432341|P2|Participant Flow|Dysport®|Botulinum toxin type A (Dysport®)
1151457|NCT00432341|P1|Participant Flow|BOTOX®|Botulinum toxin type A (BOTOX®)
1151458|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
1151459|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
1151460|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
1151461|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
1151481|NCT00432276|B2|Baseline|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151482|NCT00432276|B1|Baseline|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1152784|NCT00428974|E1|Reported Event|CF101 1 mg Twice Daily (BID)|Oral tablets given every 12 hours for 12 weeks
1151484|NCT00432276|P1|Participant Flow|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151485|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151486|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151487|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151488|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151489|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151490|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151491|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151492|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151493|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151494|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151495|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151496|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151497|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151498|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151499|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151500|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151501|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151502|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151503|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151504|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151505|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151506|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151507|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151508|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151780|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
1151509|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151510|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151511|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151512|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151513|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151514|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151515|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151516|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151517|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151518|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151519|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151520|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151521|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151522|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151523|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151524|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151525|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151526|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151527|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151528|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151529|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151530|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151531|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151532|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151533|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151534|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151535|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151536|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1153176|NCT00427960|E2|Reported Event|Atorvastatin|atorvastatin 10 mg
1151537|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151538|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151539|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1163340|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1151540|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151541|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151542|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151543|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151544|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151545|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151546|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151547|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151548|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151549|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151550|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151551|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151552|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151553|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151554|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151555|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151556|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151557|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151558|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151559|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151560|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151561|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151562|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151563|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151564|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151565|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151566|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151567|NCT00432276|E2|Reported Event|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1163341|NCT00402987|O4|Outcome|Placebo|
1151568|NCT00432276|E1|Reported Event|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
1151569|NCT00432237|B5|Baseline|Total|Total of all reporting groups
1151570|NCT00432237|B4|Baseline|Placebo|"Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack~The reported number of participants are all patients randomized who received study drug and completed the study."
1151571|NCT00432237|B3|Baseline|MK0974 300 mg|"MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack~The reported number of participants are all patients randomized who received study drug and completed the study."
1151572|NCT00432237|B2|Baseline|MK0974 150 mg|"MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack~The reported number of participants are all patients randomized who received study drug and completed the study."
1151573|NCT00432237|B1|Baseline|MK0974 50 mg|"MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack~The reported number of participants are all patients randomized who received study drug and completed the study."
1151574|NCT00432237|P4|Participant Flow|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
1151575|NCT00432237|P3|Participant Flow|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
1151576|NCT00432237|P2|Participant Flow|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
1151577|NCT00432237|P1|Participant Flow|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
1151578|NCT00432237|O4|Outcome|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
1151579|NCT00432237|O3|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
1151580|NCT00432237|O2|Outcome|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
1151581|NCT00432237|O1|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
1151582|NCT00432237|O4|Outcome|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
1151583|NCT00432237|O3|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
1151584|NCT00432237|O2|Outcome|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
1151585|NCT00432237|O1|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
1151586|NCT00432237|O4|Outcome|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
1151587|NCT00432237|O3|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
1151588|NCT00432237|O2|Outcome|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
1151589|NCT00432237|O1|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
1151590|NCT00432237|O4|Outcome|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
1151591|NCT00432237|O3|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
1151592|NCT00432237|O2|Outcome|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
1151593|NCT00432237|O1|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
1151594|NCT00432237|O4|Outcome|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
1151595|NCT00432237|O3|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
1151596|NCT00432237|O2|Outcome|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
1151597|NCT00432237|O1|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
1151598|NCT00432237|O4|Outcome|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
1151599|NCT00432237|O3|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
1151600|NCT00432237|O2|Outcome|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
1151601|NCT00432237|O1|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
1151602|NCT00432237|O4|Outcome|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
1163342|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
1151603|NCT00432237|O3|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
1151604|NCT00432237|O2|Outcome|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
1151605|NCT00432237|O1|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
1151606|NCT00432237|O4|Outcome|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
1151607|NCT00432237|O3|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
1151608|NCT00432237|O2|Outcome|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
1151609|NCT00432237|O1|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
1151610|NCT00432237|E4|Reported Event|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
1151611|NCT00432237|E3|Reported Event|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
1151612|NCT00432237|E2|Reported Event|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
1151613|NCT00432237|E1|Reported Event|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
1151614|NCT00432159|B6|Baseline|Total|Total of all reporting groups
1151615|NCT00432159|B5|Baseline|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151616|NCT00432159|B4|Baseline|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151617|NCT00432159|B3|Baseline|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151618|NCT00432159|B2|Baseline|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151619|NCT00432159|B1|Baseline|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151620|NCT00432159|P5|Participant Flow|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151621|NCT00432159|P4|Participant Flow|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151622|NCT00432159|P3|Participant Flow|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151623|NCT00432159|P2|Participant Flow|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151624|NCT00432159|P1|Participant Flow|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151625|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151626|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151627|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151628|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151738|NCT00431951|B3|Baseline|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
1151629|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151630|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151631|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151632|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151633|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151634|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151635|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151636|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151637|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151638|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151639|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151640|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151641|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151642|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151643|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151644|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151645|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151646|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151647|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151648|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151649|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151739|NCT00431951|B2|Baseline|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
1151650|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151651|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151652|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151653|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151654|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151655|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151656|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151657|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151658|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151659|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151660|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151661|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151662|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151663|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151664|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151665|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151666|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151667|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151668|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151669|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151670|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151740|NCT00431951|B1|Baseline|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
1151671|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151672|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151673|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151674|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151675|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151676|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151677|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151678|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151679|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151680|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151681|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151682|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151683|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151684|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151685|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151686|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151687|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151688|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151689|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1152003|NCT00430781|B3|Baseline|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
1151690|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151691|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151741|NCT00431951|P4|Participant Flow|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
1151692|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151693|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151694|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151695|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151696|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151697|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151698|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151699|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151700|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151701|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151702|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151703|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151704|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151705|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151706|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151707|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151708|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151709|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151732|NCT00431964|O2|Outcome|Placebo|"placebo tablets (matched to active drug in appearance)~placebo tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs~*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
1151710|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151711|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151712|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151742|NCT00431951|P3|Participant Flow|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
1151713|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151714|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151715|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151716|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151717|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151718|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151719|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151720|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151721|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151722|NCT00432159|E5|Reported Event|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151723|NCT00432159|E4|Reported Event|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151724|NCT00432159|E3|Reported Event|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151725|NCT00432159|E2|Reported Event|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
1151726|NCT00432159|E1|Reported Event|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
1151727|NCT00431964|B3|Baseline|Total|Total of all reporting groups
1151728|NCT00431964|B2|Baseline|Placebo|"placebo tablets (matched to active drug in appearance)~placebo tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs~*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
1151729|NCT00431964|B1|Baseline|Active|"azithromycin 250 mg tablets~azithromycin 250 mg tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs~*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
1151730|NCT00431964|P2|Participant Flow|Placebo|"placebo tablets (matched to active drug in appearance)~placebo tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs~*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
1151731|NCT00431964|P1|Participant Flow|Active|"azithromycin 250 mg tablets~azithromycin 250 mg tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs~*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
1151779|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
1151733|NCT00431964|O1|Outcome|Active|"azithromycin 250 mg tablets~azithromycin 250 mg tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs~*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
1151734|NCT00431964|E2|Reported Event|Placebo|"placebo tablets (matched to active drug in appearance)~placebo tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs~*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
1151735|NCT00431964|E1|Reported Event|Active|"azithromycin 250 mg tablets~azithromycin 250 mg tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs~*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
1151736|NCT00431951|B5|Baseline|Total|Total of all reporting groups
1151737|NCT00431951|B4|Baseline|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
1151743|NCT00431951|P2|Participant Flow|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
1151744|NCT00431951|P1|Participant Flow|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
1151745|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent).
1151746|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
1151747|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
1151748|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
1151749|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose to 6 subjects for 21 days, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
1151750|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
1151751|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
1151752|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
1151753|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent).
1151754|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
1151755|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
1151756|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
1151757|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent).
1151758|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
1151759|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
1151760|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
1151761|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose to 6 subjects for 21 days, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
1151762|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
1151763|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
1151764|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
1151765|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose to 6 subjects for 21 days, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
1151766|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
1151767|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
1151768|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
1151769|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent).
1151770|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
1151771|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
1151772|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
1151773|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent).
1151774|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
1151775|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
1151776|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
1151777|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose to 6 subjects for 21 days, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
1151778|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
1152004|NCT00430781|B2|Baseline|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
1151781|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent).
1151782|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
1151783|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
1151784|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
1151785|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent).
1163343|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
1151789|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose to 6 subjects for 21 days, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
1151790|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
1151791|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
1151792|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
1151793|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent).
1151794|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
1151795|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
1151796|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
1151797|NCT00431951|E4|Reported Event|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
1151798|NCT00431951|E3|Reported Event|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
1151799|NCT00431951|E2|Reported Event|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
1151800|NCT00431951|E1|Reported Event|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
1151801|NCT00431847|B5|Baseline|Total|Total of all reporting groups
1151802|NCT00431847|B4|Baseline|No Regional Anesthesia (RA)|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
1151803|NCT00431847|B3|Baseline|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
1151804|NCT00431847|B2|Baseline|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
1151805|NCT00431847|B1|Baseline|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
1151806|NCT00431847|P5|Participant Flow|Unknown Treatment Status|No patient data on exposure to Regional Anesthesia
1151807|NCT00431847|P4|Participant Flow|No Regional Anesthesia (RA)|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
1151808|NCT00431847|P3|Participant Flow|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
1151809|NCT00431847|P2|Participant Flow|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
1151810|NCT00431847|P1|Participant Flow|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
1151811|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
1151812|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
1151813|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
1151814|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
1151815|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
1151816|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
1151817|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
1151912|NCT00431444|P1|Participant Flow|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
1151818|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
1151819|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
1151820|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
1151821|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
1151822|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
1151823|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
1151824|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
1151825|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
1151826|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
1151827|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
1151828|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
1151829|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
1151830|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
1151831|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
1151832|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
1151833|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
1151834|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
1151835|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
1151836|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
1151837|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
1151838|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
1151839|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
1151840|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
1151841|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
1151842|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
1151843|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
1151844|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
1151845|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
1151913|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
1151846|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
1151847|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
1151848|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
1151849|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
1151920|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
1151850|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
1151851|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
1151852|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
1151853|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
1151854|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
1151855|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
1151856|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
1151857|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
1151858|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
1151859|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
1151860|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
1151861|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
1151862|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
1151863|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
1151864|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
1151865|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
1151866|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
1151867|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
1151868|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
1151869|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
1151870|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
1151871|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
1151872|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
1151873|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
1151874|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
1151875|NCT00431847|O4|Outcome|No RA|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
1151876|NCT00431847|O3|Outcome|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
1151877|NCT00431847|O2|Outcome|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
1151921|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
1151878|NCT00431847|O1|Outcome|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
1151879|NCT00431847|E4|Reported Event|No Regional Anesthesia (RA)|During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
1151880|NCT00431847|E3|Reported Event|RA > 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury.
1151881|NCT00431847|E2|Reported Event|RA 8 - 14 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury.
1151882|NCT00431847|E1|Reported Event|RA Within 7 Days From Injury|During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury.
1151883|NCT00431834|B1|Baseline|Entire Cohort|All subjects enrolled and treated with the Cardioblate Surgical Ablation System
1151884|NCT00431834|P1|Participant Flow|Cardioblate Surgical Ablation System|75 subjects were enrolled and treated. 62 subjects completed the study through 6 month follow-up. 3 subjects died, 7 subjects withdrew from the study, 2 subjects missed the endpoint visit, and 1 subject was lost to follow-up.
1151885|NCT00431834|O1|Outcome|Cardioblate Surgical Ablation System|
1151886|NCT00431834|O1|Outcome|Cardioblate Surgical Ablation System|All subjects who were enrolled and were treated with the Cardioblate surgical ablation system with at least 6-month post-operative follow-up or an MAE prior to the end of the 6th month window were included in the analysis.
1151887|NCT00431834|O1|Outcome|Cardioblate Surgical Ablation System|All subjects enrolled who completed 6 month follow-up and had a 24-hour Holter assessment.
1151888|NCT00431834|O1|Outcome|Cardioblate Surgical Ablation System|All subjects enrolled who completed a Holter assessment at 6 month follow-up.
1151889|NCT00431834|E1|Reported Event|Study Completion Cohort|75 subjects were enrolled and treated. 62 subjects completed the study through 6 month follow-up. 4 subjects died, 8 subjects withdrew from the study, and 1 subject was lost to follow-up.
1151890|NCT00431626|B3|Baseline|Total|Total of all reporting groups
1151891|NCT00431626|B2|Baseline|Laser TURP With Placebo|Prior to and after standard treatment with laser TURP, placebo is applied to each patient
1151892|NCT00431626|B1|Baseline|Laser TURP With Dutasteride|"Prior to and after standard treatment with laser TURP, dutasteride is applied to each patient~Dutasteride (Avodart)"
1151893|NCT00431626|P2|Participant Flow|Placebo|
1151894|NCT00431626|P1|Participant Flow|Treatment|
1151895|NCT00431626|O2|Outcome|Laser TURP With Placebo|Prior to and after standard treatment with laser TURP, placebo is applied to each patient
1151896|NCT00431626|O1|Outcome|Laser TURP With Dutasteride|"Prior to and after standard treatment with laser TURP, dutasteride is applied to each patient~Dutasteride (Avodart)"
1151897|NCT00431626|E2|Reported Event|Laser TURP With Placebo|Prior to and after standard treatment with laser TURP, placebo is applied to each patient
1151898|NCT00431626|E1|Reported Event|Laser TURP With Dutasteride|"Prior to and after standard treatment with laser TURP, dutasteride is applied to each patient~Dutasteride (Avodart)"
1151899|NCT00431496|B1|Baseline|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
1151900|NCT00431496|P1|Participant Flow|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks. Possible sequential doses during the study were 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet occurred if the intact parathyroid hormone (iPTH) level from the previous study visit was > 31.8 pmol/L (300 pg/mL), unless the participant had either reached the maximum dose (180 mg/day), the serum corrected total calcium was < 2.1 mmol/L (8.4 mg/dL), or the participant experienced an adverse event that precluded a dose increase.
1151901|NCT00431496|O1|Outcome|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
1151902|NCT00431496|O1|Outcome|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
1151903|NCT00431496|O1|Outcome|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
1151904|NCT00431496|O1|Outcome|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
1151905|NCT00431496|O1|Outcome|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
1151906|NCT00431496|O1|Outcome|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
1151907|NCT00431496|E1|Reported Event|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
1151908|NCT00431444|B3|Baseline|Total|Total of all reporting groups
1151909|NCT00431444|B2|Baseline|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
1151910|NCT00431444|B1|Baseline|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
1151911|NCT00431444|P2|Participant Flow|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
1151914|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
1151915|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
1151916|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
1151917|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
1151918|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
1151922|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
1151923|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
1151924|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
1151925|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
1151926|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
1151927|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
1151928|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
1151929|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
1151930|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
1151931|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
1151932|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
1151933|NCT00431444|E2|Reported Event|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
1151934|NCT00431444|E1|Reported Event|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
1151935|NCT00431184|B3|Baseline|Total|Total of all reporting groups
1151936|NCT00431184|B2|Baseline|Lorazepam Then Pentazocine|In the first leg of the study, lorazepam will be given to subjects randomly assigned to this group. On Day 3, subjects in this group will be given 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later. On Day 2, subjects will receive 50mg of pentazocine followed by a second dose of 50mg two hours later.
1151937|NCT00431184|B1|Baseline|Pentazocine Then Lorazepam|In the first leg of the study, pentazocine will be given to subjects randomly assigned to this group. On Day 1, subjects will receive 50mg of pentazocine followed by a second dose of 50mg two hours later. On Day 2, subjects in this group will be given 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later.
1151938|NCT00431184|P2|Participant Flow|Lorazepam Then Pentazocine|In the first leg of the study, lorazepam will be given to subjects randomly assigned to this group. On Day 3, subjects in this group will be given 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later. On Day 2, subjects will receive 50mg of pentazocine followed by a second dose of 50mg two hours later.
1151939|NCT00431184|P1|Participant Flow|Pentazocine Then Lorazepam|In the first leg of the study, pentazocine will be given to subjects randomly assigned to this group. On Day 1, subjects will receive 50mg of pentazocine followed by a second dose of 50mg two hours later. On Day 2, subjects in this group will be given 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later.
1151940|NCT00431184|O2|Outcome|Lorazepam|The results below represent the mean change in YMRS scores for all 19 subjects following administration of Lorazepam.
1151941|NCT00431184|O1|Outcome|Pentazocine|The results below represent the mean change in YMRS scores for all 19 subjects following administration of Pentazocine.
1151942|NCT00431184|O2|Outcome|Lorazepam|Subjects received 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later
1151943|NCT00431184|O1|Outcome|Pentazocine|Subjects received 50mg of pentazocine
1151944|NCT00431184|E2|Reported Event|Lorazepam|All subjects receive 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later on either Day 1 or Day 2.
1151945|NCT00431184|E1|Reported Event|Pentazocine|All subjects receive 50mg of pentazocine followed by a second dose of 50mg two hours later on either Day 1 or Day 2.
1151946|NCT00431132|B1|Baseline|Vagifem® 10 mcg|One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks
1151947|NCT00431132|P1|Participant Flow|Vagifem® 10 mcg|One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks
1151948|NCT00431132|O1|Outcome|Vagifem® 10 mcg|One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks
1151949|NCT00431132|O1|Outcome|Vagifem® 10 mcg|One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks
1151950|NCT00431132|E1|Reported Event|Vagifem® 10 mcg|One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks
1151951|NCT00431067|B1|Baseline|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
1151952|NCT00431067|P1|Participant Flow|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
1151953|NCT00431067|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
1151954|NCT00431067|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
1151955|NCT00431067|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
1151956|NCT00431067|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
1151957|NCT00431067|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
1152007|NCT00430781|P2|Participant Flow|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
1151958|NCT00431067|E1|Reported Event|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
1151959|NCT00431041|B3|Baseline|Total|Total of all reporting groups
1151960|NCT00431041|B2|Baseline|Oxybutynin IR|Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
1151961|NCT00431041|B1|Baseline|Solifenacin|Solifenacin succinate: 5 mg tablets, taken orally, once daily
1151962|NCT00431041|P2|Participant Flow|Oxybutynin IR|Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
1151963|NCT00431041|P1|Participant Flow|Solifenacin|Solifenacin succinate: 5 mg tablets, taken orally, once daily
1151964|NCT00431041|O2|Outcome|Oxybutynin IR|Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
1151965|NCT00431041|O1|Outcome|Solifenacin|Solifenacin succinate: 5 mg tablets, taken orally, once daily
1151966|NCT00431041|O2|Outcome|Oxybutynin IR|Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
1151967|NCT00431041|O1|Outcome|Solifenacin|Solifenacin succinate: 5 mg tablets, taken orally, once daily
1151968|NCT00431041|O2|Outcome|Oxybutynin IR|Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
1151969|NCT00431041|O1|Outcome|Solifenacin|Solifenacin succinate: 5 mg tablets, taken orally, once daily
1151970|NCT00431041|O2|Outcome|Oxybutynin IR|Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
1151971|NCT00431041|O1|Outcome|Solifenacin|Solifenacin succinate: 5 mg tablets, taken orally, once daily
1151972|NCT00431041|E2|Reported Event|Oxybutynin IR|Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
1151973|NCT00431041|E1|Reported Event|Solifenacin|Solifenacin succinate: 5 mg tablets, taken orally, once daily
1151974|NCT00430950|B3|Baseline|Total|Total of all reporting groups
1151975|NCT00430950|B2|Baseline|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
1151976|NCT00430950|B1|Baseline|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
1151977|NCT00430950|P2|Participant Flow|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
1151978|NCT00430950|P1|Participant Flow|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
1151979|NCT00430950|O2|Outcome|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
1151980|NCT00430950|O1|Outcome|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
1151981|NCT00430950|O2|Outcome|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
1151982|NCT00430950|O1|Outcome|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
1151983|NCT00430950|O2|Outcome|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
1151984|NCT00430950|O1|Outcome|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
1151985|NCT00430950|O2|Outcome|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
1151986|NCT00430950|O1|Outcome|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
1151987|NCT00430950|O2|Outcome|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
1151988|NCT00430950|O1|Outcome|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
1151989|NCT00430950|E2|Reported Event|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
1151990|NCT00430950|E1|Reported Event|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
1151991|NCT00430937|B3|Baseline|Total|Total of all reporting groups
1151992|NCT00430937|B2|Baseline|Pooled Comparator|Vancomycin 1 g intravenous (i.v.) twice daily or Teicoplanin 400 mg i.v. once daily following a loading dose of 400 mg administered at 0, 12 and 24 hours on day one.
1151993|NCT00430937|B1|Baseline|Daptomycin|Daptomycin 4 mg/kg intravenous (i.v.) once daily
1151994|NCT00430937|P2|Participant Flow|Pooled Comparator|Vancomycin 1 g intravenous (i.v.) twice daily or Teicoplanin 400 mg i.v. once daily following a loading dose of 400 mg administered at 0, 12 and 24 hours on day one.
1151995|NCT00430937|P1|Participant Flow|Daptomycin|Daptomycin 4 mg/kg intravenous (i.v.) once daily
1151996|NCT00430937|O2|Outcome|Pooled Comparator|Vancomycin 1 g intravenous (i.v.) twice daily or Teicoplanin 400 mg i.v. once daily following a loading dose of 400 mg administered at 0, 12 and 24 hours on day one.
1151997|NCT00430937|O1|Outcome|Daptomycin|Daptomycin 4 mg/kg intravenous (i.v.) once daily
1151998|NCT00430937|O2|Outcome|Pooled Comparator|Vancomycin 1 g intravenous (i.v.) twice daily or Teicoplanin 400 mg i.v. once daily following a loading dose of 400 mg administered at 0, 12 and 24 hours on day one.
1151999|NCT00430937|O1|Outcome|Daptomycin|Daptomycin 4 mg/kg intravenous (i.v.) once daily
1152000|NCT00430937|E2|Reported Event|Pooled Comparator|Vancomycin 1 g intravenous (i.v.) twice daily or Teicoplanin 400 mg i.v. once daily following a loading dose of 400 mg administered at 0, 12 and 24 hours on day one.
1152001|NCT00430937|E1|Reported Event|Daptomycin|Daptomycin 4 mg/kg intravenous (i.v.) once daily
1152005|NCT00430781|B1|Baseline|Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg|Lapatinib 1500 mg (6 x 250 mg tablets) and pazopanib 800 mg (2 x 400 mg tablets) daily
1152006|NCT00430781|P3|Participant Flow|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
1154338|NCT00424619|B3|Baseline|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
1152008|NCT00430781|P1|Participant Flow|Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg|Lapatinib 1500 mg (6 x 250 mg tablets) and pazopanib 800 mg (2 x 400 mg tablets) daily
1152009|NCT00430781|O2|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
1152010|NCT00430781|O1|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
1152011|NCT00430781|O3|Outcome|Combination Therapy: Lapatinib 1500 mg and Pazopanib 800|Lapatinib 1500 mg (6 x 250 mg tablets) and pazopanib 800 mg (2 x 400 mg tablets) daily
1152012|NCT00430781|O2|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
1152013|NCT00430781|O1|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
1152014|NCT00430781|O2|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
1152015|NCT00430781|O1|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
1152016|NCT00430781|O2|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
1152017|NCT00430781|O1|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
1152018|NCT00430781|O2|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
1152019|NCT00430781|O1|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
1152020|NCT00430781|O2|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
1152021|NCT00430781|O1|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
1152022|NCT00430781|O2|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
1152023|NCT00430781|O1|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
1152024|NCT00430781|O3|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
1152025|NCT00430781|O2|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
1152026|NCT00430781|O1|Outcome|Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg|Lapatinib 1500 mg (6 x 250 mg tablets) and pazopanib 800 mg (2 x 400 mg tablets) daily
1152027|NCT00430781|E3|Reported Event|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
1152028|NCT00430781|E2|Reported Event|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
1152029|NCT00430781|E1|Reported Event|Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg|Lapatinib 1500 mg (6 x 250 mg tablets) and pazopanib 800 mg (2 x 400 mg tablets) daily
1152030|NCT00430768|B4|Baseline|Total|Total of all reporting groups
1152031|NCT00430768|B3|Baseline|Group 3 High Dose|"rAAV1-CB-hAAT 6.0 x10e13 vg~Group 2 receives rAAV1-CB-hAAT 2.1 x1013 vg"
1152032|NCT00430768|B2|Baseline|Group 2 Middle Dose|"2.1 x 10e13 vector genomes~Group 2 receives rAAV1-CB-hAAT 2.1 x1013 vg"
1152033|NCT00430768|B1|Baseline|Group 1 Low Dose|"6.9 x10e12 vector genomes~Group 1 receives rAAV1-CB-hAAT 6.9 x1012 vg (vector genomes), e"
1152034|NCT00430768|P3|Participant Flow|Group 3 High Dose|"rAAV1-CB-hAAT 6.0 x10e13 vg~Group 3 receives rAAV1-CB-hAAT 6.0 x10e13 vg"
1152035|NCT00430768|P2|Participant Flow|Group 2 Middle Dose|"2.1 x 10e13 vector genomes; 2.2 x 10e13 vector genomes~Group 2, 1 subject received rAAV1-CB-hAAT 2.1 x10e13 vg; 202 and 203 received rAAV1-CB-hAAT 2.2 x10e13 vg"
1152036|NCT00430768|P1|Participant Flow|Group 1 Low Dose|"6.9 x10e12 vector genomes (vg)~Group 1 receives rAAV1-CB-hAAT 6.9 x10e12 vg."
1152037|NCT00430768|O6|Outcome|303 (High Dose)|Subject 303 M-specific AAT Level
1152038|NCT00430768|O5|Outcome|302 (High Dose)|Subject 302 M-specific AAT Level
1152039|NCT00430768|O4|Outcome|301 (High Dose)|Subject 301M-specific AAT Level
1152040|NCT00430768|O3|Outcome|203 (Medium Dose)|Subject 203 M-specific AAT Level
1152041|NCT00430768|O2|Outcome|202 (Medium Dose)|Subject 202 M-specific AAT Level
1152042|NCT00430768|O1|Outcome|201 (Medium Dose)|Subject 201 M-specific AAT Level
1152043|NCT00430768|O3|Outcome|Group 3 High Dose|
1152044|NCT00430768|O2|Outcome|Group 2 Middle Dose|
1152045|NCT00430768|O1|Outcome|Group 1 Low Dose|
1152046|NCT00430768|E3|Reported Event|Group 3 High Dose|"rAAV1-CB-hAAT 6.0 x10e13 vg~Group 3 receives rAAV1-CB-hAAT 6.0 x10e13 vg"
1152047|NCT00430768|E2|Reported Event|Group 2 Middle Dose|"2.2 x 10e13 vector genomes~Group 2 receives rAAV1-CB-hAAT 2.1 x10e13 vg"
1152048|NCT00430768|E1|Reported Event|Group 1 Low Dose|"6.9 x10e12 vector genomes~e. Group 1 receives rAAV1-CB-hAAT 6.9 x10e12 vg (vector genomes)"
1152049|NCT00430755|B1|Baseline|Inpatients With the Need for History Taking|Every patient, who needs to get a medical history taken
1152050|NCT00430755|P1|Participant Flow|Inpatients With the Need for History Taking|Every patient, who needs to get a medical history taken
1152051|NCT00430755|O1|Outcome|Inpatients With the Need for History Taking|Every patient, who needs to get a medical history taken
1152052|NCT00430755|E1|Reported Event|Inpatients With the Need for History Taking|Every patient, who needs to get a medical history taken
1152053|NCT00430716|B4|Baseline|Total|Total of all reporting groups
1152054|NCT00430716|B3|Baseline|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
1152055|NCT00430716|B2|Baseline|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
1152056|NCT00430716|B1|Baseline|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
1152057|NCT00430716|P3|Participant Flow|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
1153177|NCT00427960|E1|Reported Event|Rosuvastatin|rosuvastatin 5 mg
1152058|NCT00430716|P2|Participant Flow|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
1152228|NCT00430638|O2|Outcome|Olmesartan Group|Participants received olmesatan medoxomil plus hydrochlorothiazide, if necessary.
1152059|NCT00430716|P1|Participant Flow|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
1152060|NCT00430716|O3|Outcome|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
1152061|NCT00430716|O2|Outcome|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
1152062|NCT00430716|O1|Outcome|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
1152063|NCT00430716|O3|Outcome|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
1152064|NCT00430716|O2|Outcome|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
1152065|NCT00430716|O1|Outcome|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
1152066|NCT00430716|O3|Outcome|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
1152067|NCT00430716|O2|Outcome|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
1152068|NCT00430716|O1|Outcome|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
1152069|NCT00430716|O3|Outcome|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
1152070|NCT00430716|O2|Outcome|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
1152071|NCT00430716|O1|Outcome|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
1152072|NCT00430716|O3|Outcome|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
1152073|NCT00430716|O2|Outcome|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
1152074|NCT00430716|O1|Outcome|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
1152075|NCT00430716|O3|Outcome|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
1152076|NCT00430716|O2|Outcome|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
1152077|NCT00430716|O1|Outcome|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
1152078|NCT00430716|O3|Outcome|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
1152079|NCT00430716|O2|Outcome|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
1152080|NCT00430716|O1|Outcome|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
1152081|NCT00430716|O3|Outcome|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
1152082|NCT00430716|O2|Outcome|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
1152083|NCT00430716|O1|Outcome|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
1153178|NCT00427934|B5|Baseline|Total|Total of all reporting groups
1152084|NCT00430716|E3|Reported Event|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
1152085|NCT00430716|E2|Reported Event|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
1152086|NCT00430716|E1|Reported Event|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
1152087|NCT00430677|B4|Baseline|Total|Total of all reporting groups
1152088|NCT00430677|B3|Baseline|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152089|NCT00430677|B2|Baseline|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152090|NCT00430677|B1|Baseline|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152091|NCT00430677|P3|Participant Flow|Placebo|Short-term period: Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
1152092|NCT00430677|P2|Participant Flow|Abatacept 10/10 mg/kg|Short-term period: Abatacept 10/10 mg/kg regimen by IV infusion: abatacept (fixed dose) approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
1152093|NCT00430677|P1|Participant Flow|Abatacept 30/10 mg/kg|Short-term period: Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept (fixed dose) approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral Mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
1152094|NCT00430677|O1|Outcome|Abatacept 10 mg/kg|Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
1152095|NCT00430677|O1|Outcome|Abatacept 10 mg/kg|Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
1152096|NCT00430677|O1|Outcome|Abatacept 10 mg/kg|Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
1152097|NCT00430677|O3|Outcome|Placebo|Short-term period: Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
1152098|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Short-term period: Abatacept 10/10 mg/kg regimen by IV infusion: abatacept (fixed dose) approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
1152099|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Short-term period: Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept (fixed dose) approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral Mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
1152100|NCT00430677|O1|Outcome|Abatacept 10 mg/kg|Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
1152101|NCT00430677|O1|Outcome|Abatacept 10 mg/kg|Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
1152102|NCT00430677|O3|Outcome|Placebo|Short-term period: Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
1152262|NCT00430508|O2|Outcome|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
1152103|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Short-term period: Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
1152229|NCT00430638|O1|Outcome|Placebo|Patient received placebo tablets.
1152882|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
1152104|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Short-term period: Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
1152105|NCT00430677|O3|Outcome|Placebo|Short-term period: Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) Short-term period: by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
1152106|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Short-term period: Abatacept 10/10 mg/kg regimen by IV infusion: abatacept (fixed dose) approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
1152107|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Short-term period: Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept (fixed dose) approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral Mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
1152108|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
1152109|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
1152110|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Short-term period: Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
1152111|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152112|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152113|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152114|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152115|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152116|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152117|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152118|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152119|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152120|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152121|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152122|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152270|NCT00430508|O2|Outcome|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
1152123|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152124|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152125|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152126|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152127|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152128|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152129|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152130|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152131|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152132|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152133|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152134|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152135|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152136|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152137|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152138|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152139|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152140|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152141|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152142|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152143|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152144|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152263|NCT00430508|O1|Outcome|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
1152145|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152146|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152147|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152472|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
1152148|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152149|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152150|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152151|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152152|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152153|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152154|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152155|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152156|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152157|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152158|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152159|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152160|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152161|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152162|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152163|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152164|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152165|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152166|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152167|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152168|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152169|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152170|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152171|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152172|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152513|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
1152173|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152174|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152175|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152176|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152177|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152178|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152179|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152180|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152181|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152182|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152183|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152184|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152185|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152186|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152187|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152188|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152189|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152190|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152191|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152192|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152193|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152264|NCT00430508|O4|Outcome|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
1155161|NCT00423683|O2|Outcome|Arixtra and Filter|
1152194|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152195|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152196|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152197|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1163344|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1152198|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152199|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152200|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152201|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152202|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152203|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152204|NCT00430677|O3|Outcome|Placebo|Placebo (dextrose 5% in water) or normal saline by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152205|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral mycofenolate mofetil (MMF) and oral prednisone or prednisone-equivalent
1152206|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152207|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152208|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept (fixed dose) approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152209|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept (fixed dose) approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent
1152210|NCT00430677|E3|Reported Event|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
1152211|NCT00430677|E2|Reported Event|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: Participants received abatacept (fixed dose) approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent.
1152212|NCT00430677|E1|Reported Event|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: In the double-blind period, participants received abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57. In the open-label period, participants received abatacept (fixed dose) approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral Mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent
1152213|NCT00430638|B3|Baseline|Total|Total of all reporting groups
1152214|NCT00430638|B2|Baseline|Placebo Group|Participants were randomized to a placebo (Pbo) group. The Pbo participants remained in the pbo group for the entire 12 weeks of treatment.
1152215|NCT00430638|B1|Baseline|Olmesartan Group|Participants were randomized to an olmesartan (Olm) based active treatment group. After 3,6,and 9 weeks of treatment participants were titrated to the next regiment if their blood pressure was greater than 120/80 mmHg. The active treatment group received olm 20 mg (weeks 1-3), olm 40 mg (weeks 4-6), olm 40 mg + 12.5 mg hydrchlorothiazide (HCTZ) (weeks 7-9), and olm 40 mg + 25 mg HCTZ (weeks 10-12).
1152216|NCT00430638|P2|Participant Flow|Olmesartan Group|140 participants were randomized to the olmesartan group. These participants remained in this group for the entire study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on olmesartan 20 mg; after 3 weeks, if necessary, olmesartan 40 mg; after 6 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 25 mg.
1152265|NCT00430508|O3|Outcome|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
1155162|NCT00423683|O1|Outcome|Arixtra|
1152217|NCT00430638|P1|Participant Flow|Placebo (Pbo) Group|138 were randomized to placebo. Participants remained in the placebo group for the duration of the study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on placebo matching olmesartan 20 mg; after 3 weeks, if necessary, placebo matching olmesartan 40 mg; after 6 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 25 mg.
1152218|NCT00430638|O1|Outcome|Olmesartan vs. Placebo|
1152219|NCT00430638|O1|Outcome|Olmesartan vs. Placebo|
1152220|NCT00430638|O1|Outcome|Olmesartan vs. Placebo|
1152221|NCT00430638|O1|Outcome|Olmesartan vs. Placebo|
1152222|NCT00430638|O1|Outcome|Olmesartan vs. Placebo|
1152223|NCT00430638|O1|Outcome|Olmesartan vs. Placebo|
1152224|NCT00430638|O1|Outcome|Olmesartan vs. Placebo|145 females participants were analyzed.
1152225|NCT00430638|O1|Outcome|Olmesartan vs. Placebo|
1152226|NCT00430638|O2|Outcome|Olmesartan Group|Participants received olmesartan medoxomil tablets + hydrochlorothiazide tablets, if necessary, once daily for the duration of the 12-week active treatment period.
1152227|NCT00430638|O1|Outcome|Placebo Group|Patient received placebo tablets throughout the 12-week active treatment period.
1152230|NCT00430638|E2|Reported Event|Olmesartan Group|140 participants were randomized to the olmesartan group. These participants remained in this group for the entire study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on olmesartan 20 mg; after 3 weeks, if necessary, olmesartan 40 mg; after 6 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 25 mg.
1152231|NCT00430638|E1|Reported Event|Placebo (Pbo) Group|138 were randomized to placebo. Participants remained in the placebo group for the duration of the study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on placebo matching olmesartan 20 mg; after 3 weeks, if necessary, placebo matching olmesartan 40 mg; after 6 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 25 mg.
1152232|NCT00430625|B3|Baseline|Total|Total of all reporting groups
1152233|NCT00430625|B2|Baseline|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
1152234|NCT00430625|B1|Baseline|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
1152235|NCT00430625|P2|Participant Flow|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
1152236|NCT00430625|P1|Participant Flow|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
1152237|NCT00430625|O2|Outcome|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
1152238|NCT00430625|O1|Outcome|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
1152239|NCT00430625|O2|Outcome|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
1152240|NCT00430625|O1|Outcome|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
1152241|NCT00430625|O2|Outcome|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
1152242|NCT00430625|O1|Outcome|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
1152243|NCT00430625|O2|Outcome|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
1152244|NCT00430625|O1|Outcome|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
1152245|NCT00430625|O2|Outcome|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
1152246|NCT00430625|O1|Outcome|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
1152247|NCT00430625|O1|Outcome|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
1152248|NCT00430625|O1|Outcome|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
1152249|NCT00430625|E2|Reported Event|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
1152250|NCT00430625|E1|Reported Event|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
1152251|NCT00430508|B5|Baseline|Total|Total of all reporting groups
1152252|NCT00430508|B4|Baseline|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 40/0mg tablets, once daily for 8 weeks
1152253|NCT00430508|B3|Baseline|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 20/12.5mg tablets, once daily for 8 weeks
1152254|NCT00430508|B2|Baseline|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 40/12.5mg tablets, once daily for 8 weeks
1152255|NCT00430508|B1|Baseline|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 40/25mg tablets, once daily for 8 weeks
1152256|NCT00430508|P4|Participant Flow|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 40/0mg tablets, once daily for 8 weeks
1152257|NCT00430508|P3|Participant Flow|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 20/12.5mg tablets, once daily for 8 weeks
1152258|NCT00430508|P2|Participant Flow|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 40/12.5mg tablets, once daily for 8 weeks
1152259|NCT00430508|P1|Participant Flow|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 40/25mg tablets, once daily for 8 weeks
1152260|NCT00430508|O4|Outcome|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
1152261|NCT00430508|O3|Outcome|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
1152266|NCT00430508|O2|Outcome|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
1152267|NCT00430508|O1|Outcome|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
1152268|NCT00430508|O4|Outcome|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
1152269|NCT00430508|O3|Outcome|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
1152271|NCT00430508|O1|Outcome|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
1152272|NCT00430508|O4|Outcome|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
1152273|NCT00430508|O3|Outcome|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
1152274|NCT00430508|O2|Outcome|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
1152275|NCT00430508|O1|Outcome|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
1152276|NCT00430508|O4|Outcome|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
1152277|NCT00430508|O3|Outcome|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
1152278|NCT00430508|O2|Outcome|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
1152279|NCT00430508|O1|Outcome|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
1152280|NCT00430508|O4|Outcome|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
1152281|NCT00430508|O3|Outcome|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
1152282|NCT00430508|O2|Outcome|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
1152283|NCT00430508|O1|Outcome|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
1152284|NCT00430508|O4|Outcome|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
1152285|NCT00430508|O3|Outcome|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
1152286|NCT00430508|O2|Outcome|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
1152287|NCT00430508|O1|Outcome|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
1152288|NCT00430508|O4|Outcome|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
1152289|NCT00430508|O3|Outcome|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
1152290|NCT00430508|O2|Outcome|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
1152291|NCT00430508|O1|Outcome|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
1152292|NCT00430495|B5|Baseline|Total|Total of all reporting groups
1152293|NCT00430495|B4|Baseline|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
1152294|NCT00430495|B3|Baseline|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
1152295|NCT00430495|B2|Baseline|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
1152296|NCT00430495|B1|Baseline|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
1152297|NCT00430495|P4|Participant Flow|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
1152298|NCT00430495|P3|Participant Flow|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
1152299|NCT00430495|P2|Participant Flow|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
1152300|NCT00430495|P1|Participant Flow|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
1152301|NCT00430495|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
1152302|NCT00430495|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
1152505|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
1152303|NCT00430495|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
1152304|NCT00430495|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
1152305|NCT00430495|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
1152306|NCT00430495|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
1163345|NCT00402987|O3|Outcome|Placebo|
1152307|NCT00430495|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
1152308|NCT00430495|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
1152309|NCT00430495|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
1152310|NCT00430495|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
1152311|NCT00430495|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
1152312|NCT00430495|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
1152313|NCT00430495|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
1152314|NCT00430495|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
1152315|NCT00430495|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
1152316|NCT00430495|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
1152317|NCT00430495|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
1152318|NCT00430495|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
1152319|NCT00430495|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
1152320|NCT00430495|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
1152321|NCT00430495|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
1152322|NCT00430495|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
1152323|NCT00430495|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
1152324|NCT00430495|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
1152325|NCT00430495|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
1152326|NCT00430495|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
1152327|NCT00430495|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
1152328|NCT00430495|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
1152329|NCT00430495|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
1152330|NCT00430495|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
1152331|NCT00430495|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
1152332|NCT00430495|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
1152333|NCT00430495|E4|Reported Event|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
1152334|NCT00430495|E3|Reported Event|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
1152335|NCT00430495|E2|Reported Event|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
1152336|NCT00430495|E1|Reported Event|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
1152337|NCT00430352|B1|Baseline|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
1152338|NCT00430352|P1|Participant Flow|Rituximab 375 Milligrams Per Square Meter (mg/m^2)|Participants received rituximab 375 mg/m^2 intravenously (IV) once every 8 weeks for a total 12 infusions until progression, relapse, start of a new treatment, death, or toxicity.
1152339|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
1152340|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
1152341|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
1152342|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
1152343|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
1152344|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
1152345|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
1152346|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
1152347|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
1152348|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
1152349|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
1152350|NCT00430352|E1|Reported Event|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
1152351|NCT00430300|B5|Baseline|Total|Total of all reporting groups
1152352|NCT00430300|B4|Baseline|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152353|NCT00430300|B3|Baseline|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152354|NCT00430300|B2|Baseline|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152355|NCT00430300|B1|Baseline|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152356|NCT00430300|P4|Participant Flow|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152357|NCT00430300|P3|Participant Flow|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152358|NCT00430300|P2|Participant Flow|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152359|NCT00430300|P1|Participant Flow|UK-432,097 150 Mcg|UK-432,097 150 microgram (mcg) capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide metered dose inhaler (MDI) 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152360|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152760|NCT00429026|B1|Baseline|Conditioning Regimen|Chemotherapy including combinations of Fludarabine, Melphalan, Cyclophosphamide
1152361|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152362|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152514|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
1156283|NCT00421993|O3|Outcome|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
1152363|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152364|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152365|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152366|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152367|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152368|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152369|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152370|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152371|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152372|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152373|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152374|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152375|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152376|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152542|NCT00429949|O2|Outcome|Dasatinib 100 mg BID|In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle.
1155685|NCT00422695|B2|Baseline|Healthy Controls|HIV -ve subjects
1152377|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152378|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152379|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1156284|NCT00421993|O2|Outcome|Adapalene Gel|Adapalene Topical Gel
1152380|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152381|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152382|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152383|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152384|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152385|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152386|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152387|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152388|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152389|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152390|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152391|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152392|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152393|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152394|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152395|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152396|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1163346|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
1152397|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152398|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152399|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152400|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152401|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152402|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152403|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152404|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152405|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152406|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152407|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152408|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152409|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152410|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152411|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152412|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152413|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1163347|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1152414|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152415|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152416|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152417|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152418|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152419|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152420|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152421|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152422|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152423|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152424|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152425|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152426|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152427|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152428|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152429|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152430|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1163348|NCT00402987|O3|Outcome|Placebo|
1152431|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152432|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152433|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152434|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152435|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152436|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152437|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152438|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152439|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152440|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152441|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152442|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152443|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152444|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152445|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152446|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152447|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1163349|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
1152448|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152449|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152450|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152451|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152452|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152453|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152454|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152455|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152456|NCT00430300|E4|Reported Event|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152457|NCT00430300|E3|Reported Event|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152458|NCT00430300|E2|Reported Event|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152459|NCT00430300|E1|Reported Event|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
1152460|NCT00430248|B4|Baseline|Total|Total of all reporting groups
1152461|NCT00430248|B3|Baseline|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
1152462|NCT00430248|B2|Baseline|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
1152463|NCT00430248|B1|Baseline|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
1152543|NCT00429949|O1|Outcome|Dasatinib 70 mg BID|Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.
1152464|NCT00430248|P3|Participant Flow|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
1152465|NCT00430248|P2|Participant Flow|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
1152466|NCT00430248|P1|Participant Flow|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
1152467|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
1152468|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
1152469|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
1152470|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
1152471|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
1152473|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
1152474|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
1152475|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
1152476|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
1152477|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
1152478|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
1152479|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
1152480|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
1152481|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
1152482|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
1152483|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
1152484|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
1152485|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
1152486|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
1152487|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
1152488|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
1152489|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
1152490|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
1152491|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
1152492|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
1152493|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
1152494|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
1152495|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
1152496|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
1152497|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
1152498|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
1152499|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
1152500|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
1152501|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
1152502|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
1152503|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
1152504|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
1152506|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
1152507|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
1152508|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
1152509|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
1152510|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
1152511|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
1152512|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
1152515|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
1152516|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
1152517|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
1152518|NCT00430248|E3|Reported Event|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
1152519|NCT00430248|E2|Reported Event|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
1152520|NCT00430248|E1|Reported Event|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
1152521|NCT00430092|B4|Baseline|Total|Total of all reporting groups
1152522|NCT00430092|B3|Baseline|Placebo|Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
1152523|NCT00430092|B2|Baseline|Difluprednate 0.05% QID|Difluprednate 0.05% 1 drop QID for 14 days
1152524|NCT00430092|B1|Baseline|Difluprednate 0.05% BID|Difluprednate 0.05% 1 drop BID for 14 days
1152525|NCT00430092|P3|Participant Flow|Placebo|Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
1152526|NCT00430092|P2|Participant Flow|Difluprednate 0.05% QID|Difluprednate 0.05% 1 drop QID for 14 days
1152527|NCT00430092|P1|Participant Flow|Difluprednate 0.05% BID|Difluprednate 0.05% 1 drop BID for 14 days
1152528|NCT00430092|O3|Outcome|Placebo|Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
1152529|NCT00430092|O2|Outcome|Difluprednate 0.05% QID|Difluprednate 0.05% 1 drop QID for 14 days
1152530|NCT00430092|O1|Outcome|Difluprednate 0.05% BID|Difluprednate 0.05% 1 drop BID for 14 days
1152531|NCT00430027|B1|Baseline|Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy|Patients enrolled on the trial received neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This was followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab
1152532|NCT00430027|P1|Participant Flow|Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy|Patients enrolled on the trial received neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This was followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab
1152533|NCT00430027|O1|Outcome|Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy|Patients enrolled on the trial received neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This was followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab
1152534|NCT00430027|E1|Reported Event|Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy|Patients enrolled on the trial received neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This was followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab
1152535|NCT00429949|B1|Baseline|Dasatinib|Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.
1152536|NCT00429949|P1|Participant Flow|Dasatinib|Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.
1152537|NCT00429949|O1|Outcome|Dasatinib|"Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.~In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle."
1152538|NCT00429949|O1|Outcome|Dasatinib|"Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.~In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle."
1152539|NCT00429949|O1|Outcome|Dasatinib|"Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.~In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle."
1152540|NCT00429949|O1|Outcome|Dasatinib|"Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.~In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle."
1152541|NCT00429949|O1|Outcome|Dasatinib|"Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.~In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle."
1152762|NCT00429026|O1|Outcome|Conditioning Regimen|Chemotherapy including combinations of Fludarabine, Melphalan, Cyclophosphamide
1152544|NCT00429949|E1|Reported Event|Dasatinib|"Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.~In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle."
1152545|NCT00429923|B4|Baseline|Total|Total of all reporting groups
1152546|NCT00429923|B3|Baseline|Placebo|Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
1152547|NCT00429923|B2|Baseline|Difluprednate 0.05% QID|Difluprednate 0.05% 1 drop QID for 14 days.
1152548|NCT00429923|B1|Baseline|Difluprednate 0.05% BID|Difluprednate 0.05% 1 drop BID for 14 days.
1152578|NCT00429663|O2|Outcome|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment~locking periarticular plate: Standard of care device for femur fractures"
1163350|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1152549|NCT00429923|P3|Participant Flow|Placebo|Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
1152550|NCT00429923|P2|Participant Flow|Difluprednate 0.05% QID|Difluprednate 0.05% 1 drop QID for 14 days.
1152551|NCT00429923|P1|Participant Flow|Difluprednate 0.05% BID|Difluprednate 0.05% 1 drop BID for 14 days.
1152552|NCT00429923|O3|Outcome|Placebo|Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
1152553|NCT00429923|O2|Outcome|Difluprednate 0.05% QID|Difluprednate 0.05% 1 drop QID for 14 days.
1152554|NCT00429923|O1|Outcome|Difluprednate 0.05% BID|Difluprednate 0.05% 1 drop BID for 14 days.
1152555|NCT00429793|B1|Baseline|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1152556|NCT00429793|P1|Participant Flow|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1152557|NCT00429793|O1|Outcome|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1152558|NCT00429793|O1|Outcome|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1152559|NCT00429793|O1|Outcome|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1152560|NCT00429793|O1|Outcome|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1152561|NCT00429793|E1|Reported Event|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1152562|NCT00429702|B3|Baseline|Total|Total of all reporting groups
1152563|NCT00429702|B2|Baseline|Control Arm Saline|"Patients receive ondansetron hydrochloride IV twice daily and dexamethasone IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive saline by continuous infusion pump.~Decadron®: Given IV~ondansetron hydrochloride: Given IV"
1152564|NCT00429702|B1|Baseline|Benadryl® Ativan® Decadron® (BAD) Pump|"Patients receive ondansetron hydrochloride IV twice daily and saline IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive diphenhydramine hydrochloride, lorazepam, and dexamethasone by continuous infusion pump.~Decadron®: Given IV~Benadryl®: Given IV~Ativan®: Given IV~ondansetron hydrochloride: Given IV"
1152565|NCT00429702|P2|Participant Flow|Control Arm Saline|"Patients receive ondansetron hydrochloride IV twice daily and dexamethasone IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive saline by continuous infusion pump.~Decadron®: Given IV~ondansetron hydrochloride: Given IV"
1152566|NCT00429702|P1|Participant Flow|Benadryl® Ativan® Decadron® (BAD) Pump|"Patients receive ondansetron hydrochloride IV twice daily and saline IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive diphenhydramine hydrochloride, lorazepam, and dexamethasone by continuous infusion pump.~Decadron®: Given IV~Benadryl®: Given IV~Ativan®: Given IV~ondansetron hydrochloride: Given IV"
1152567|NCT00429702|O2|Outcome|Control Arm Saline|"Patients receive ondansetron hydrochloride IV twice daily and dexamethasone IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive saline by continuous infusion pump.~Decadron®: Given IV~ondansetron hydrochloride: Given IV"
1152568|NCT00429702|O1|Outcome|Benadryl® Ativan® Decadron® (BAD) Pump|"Patients receive ondansetron hydrochloride IV twice daily and saline IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive diphenhydramine hydrochloride, lorazepam, and dexamethasone by continuous infusion pump.~Decadron®: Given IV~Benadryl®: Given IV~Ativan®: Given IV~ondansetron hydrochloride: Given IV"
1152569|NCT00429702|O2|Outcome|Control Arm Saline|"Patients receive ondansetron hydrochloride IV twice daily and dexamethasone IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive saline by continuous infusion pump.~Decadron®: Given IV~ondansetron hydrochloride: Given IV"
1152570|NCT00429702|O1|Outcome|Benadryl® Ativan® Decadron® (BAD) Pump|"Patients receive ondansetron hydrochloride IV twice daily and saline IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive diphenhydramine hydrochloride, lorazepam, and dexamethasone by continuous infusion pump.~Decadron®: Given IV~Benadryl®: Given IV~Ativan®: Given IV~ondansetron hydrochloride: Given IV"
1152571|NCT00429702|E2|Reported Event|Control Arm Saline|"Patients receive ondansetron hydrochloride IV twice daily and dexamethasone IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive saline by continuous infusion pump.~Decadron®: Given IV~ondansetron hydrochloride: Given IV"
1152761|NCT00429026|P1|Participant Flow|Conditioning Regimen|Chemotherapy including combinations of Fludarabine, Melphalan, Cyclophosphamide
1152572|NCT00429702|E1|Reported Event|Benadryl® Ativan® Decadron® (BAD) Pump|"Patients receive ondansetron hydrochloride IV twice daily and saline IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive diphenhydramine hydrochloride, lorazepam, and dexamethasone by continuous infusion pump.~Decadron®: Given IV~Benadryl®: Given IV~Ativan®: Given IV~ondansetron hydrochloride: Given IV"
1152573|NCT00429663|B3|Baseline|Total|Total of all reporting groups
1152574|NCT00429663|B2|Baseline|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment~locking periarticular plate: Standard of care device for femur fractures"
1152575|NCT00429663|B1|Baseline|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment~reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
1152576|NCT00429663|P2|Participant Flow|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment~locking periarticular plate: Standard of care device for femur fractures"
1152577|NCT00429663|P1|Participant Flow|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment~reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
1152579|NCT00429663|O1|Outcome|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment~reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
1152580|NCT00429663|O2|Outcome|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment~locking periarticular plate: Standard of care device for femur fractures"
1152581|NCT00429663|O1|Outcome|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment~reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
1152582|NCT00429663|O2|Outcome|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment~locking periarticular plate: Standard of care device for femur fractures"
1152583|NCT00429663|O1|Outcome|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment~reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
1152584|NCT00429663|O2|Outcome|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment~locking periarticular plate: Standard of care device for femur fractures"
1152585|NCT00429663|O1|Outcome|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment~reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
1152586|NCT00429663|O2|Outcome|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment~locking periarticular plate: Standard of care device for femur fractures"
1152587|NCT00429663|O1|Outcome|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment~reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
1152588|NCT00429663|E2|Reported Event|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment~locking periarticular plate: Standard of care device for femur fractures"
1152589|NCT00429663|E1|Reported Event|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment~reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
1152590|NCT00429572|B1|Baseline|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
1152591|NCT00429572|P1|Participant Flow|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
1152592|NCT00429572|O1|Outcome|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
1152593|NCT00429572|O1|Outcome|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
1152594|NCT00429572|O1|Outcome|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
1152595|NCT00429572|O1|Outcome|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
1152596|NCT00429572|O1|Outcome|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
1152597|NCT00429572|E1|Reported Event|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
1152598|NCT00429507|B1|Baseline|Samarium 153-EDTMP + Stem Cell Transplant|Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.
1152599|NCT00429507|P1|Participant Flow|Samarium 153-EDTMP + Stem Cell Transplant|Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.
1152600|NCT00429507|O1|Outcome|Samarium 153-EDTMP + Stem Cell Transplant|Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.
1152601|NCT00429507|E1|Reported Event|Samarium 153-EDTMP + Stem Cell Transplant|Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.
1152602|NCT00429494|B1|Baseline|Leuprolide Acetate|Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before HSCT transplant and 3 months post-transplant.
1152603|NCT00429494|P1|Participant Flow|Leuprolide Acetate|Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before hematopoietic stem cell transplantation (HSCT) transplant and 3 months post-transplant.
1152604|NCT00429494|O1|Outcome|Leuprolide Acetate|Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before HSCT transplant and 3 months post-transplant.
1152605|NCT00429494|E1|Reported Event|Leuprolide Acetate|Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before HSCT transplant and 3 months post-transplant.
1152670|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
1152606|NCT00429416|B1|Baseline|LLME to Decrease GVHD Following HSC T|To determine if an experimental agent, LLME, can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).
1152607|NCT00429416|P1|Participant Flow|LLME to Decrease GVHD Following HSC T|"To determine if an experimental agent, L-leucyl-L-leucine Methyl Ester (LLME), can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).~Treatment Outline:~Day -6: Fludarabine 30 mg/m2 IV, Cytarabine 2 gm/m2 IV Day -5: Fludarabine 30 mg/m2 IV, Cyclophosphamide 1 gm/m2 IV, Mesna 1 gm/m2 IV Day -4: Fludarabine 30 mg/m2 IV, Cytarabine 2 gm/m2 IV, Mesna 1 gm/m2 IV Day -3: Fludarabine 30 mg/m2 IV, Cyclophosphamide 1 gm/m2 IV, Mesna 1 gm/m2 IV Day -2: Fludarabine 30 mg/m2 IV, Cytarabine 2 gm/m2 IV, Mesna 1 gm/m2 IV Day -1: Rest day Day 0: CD34 selected allogeneic stem cell infusion with 5x104/kg untreated T cells Day 1: Infusion of LLME treated donor CD34 – cells"
1152608|NCT00429416|O1|Outcome|LLME to Decrease GVHD Following HSC T|To determine if an experimental agent, LLME, can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).
1152785|NCT00428922|B1|Baseline|Trastuzumab, Bevacizumab, and Docetaxel|Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]
1152609|NCT00429416|O1|Outcome|LLME to Decrease GVHD Following HSC T|To determine if an experimental agent, LLME, can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).
1152610|NCT00429416|O1|Outcome|LLME to Decrease GVHD Following HSC T|To determine if an experimental agent, LLME, can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).
1152611|NCT00429416|O1|Outcome|LLME to Decrease GVHD Following HSC T|To determine if an experimental agent, LLME, can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).
1152612|NCT00429416|O1|Outcome|LLME to Decrease GVHD Following HSC T|To determine if an experimental agent, LLME, can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).
1152613|NCT00429416|E1|Reported Event|LLME to Decrease GVHD Following HSC T|To determine if an experimental agent, LLME, can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).
1152614|NCT00429403|B3|Baseline|Total|Total of all reporting groups
1152615|NCT00429403|B2|Baseline|No Goserelin|
1152616|NCT00429403|B1|Baseline|Goserelin|3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy.
1152617|NCT00429403|P2|Participant Flow|No Goserelin|
1152618|NCT00429403|P1|Participant Flow|Goserelin|3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy.
1152619|NCT00429403|O2|Outcome|No Goserelin|
1152620|NCT00429403|O1|Outcome|Goserelin|3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy.
1152621|NCT00429403|E2|Reported Event|No Goserelin|
1152622|NCT00429403|E1|Reported Event|Goserelin|3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy.
1152623|NCT00429364|B3|Baseline|Total|Total of all reporting groups
1152624|NCT00429364|B2|Baseline|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
1152625|NCT00429364|B1|Baseline|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
1152626|NCT00429364|P2|Participant Flow|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
1152627|NCT00429364|P1|Participant Flow|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
1152628|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
1152629|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
1152630|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
1152631|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
1152632|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
1152633|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
1152634|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
1152635|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
1152636|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
1152637|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
1152638|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
1156436|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
1152639|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
1152640|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
1152641|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
1152642|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
1152643|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
1152644|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
1152883|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
1152645|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
1152646|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
1152647|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
1152648|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
1152649|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
1152650|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
1152651|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
1152652|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
1152653|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
1152654|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
1152655|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
1152656|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
1152657|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
1152658|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
1152659|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
1152660|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
1152661|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
1152662|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
1152663|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
1152664|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
1152665|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
1152666|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
1152667|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
1152668|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
1152669|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
1152671|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
1152672|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
1152673|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
1152674|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
1152675|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
1152786|NCT00428922|P1|Participant Flow|Trastuzumab, Bevacizumab, and Docetaxel|Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]
1152676|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
1152677|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
1152678|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
1152679|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
1152680|NCT00429364|E2|Reported Event|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
1152681|NCT00429364|E1|Reported Event|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
1152682|NCT00429299|B4|Baseline|Total|Total of all reporting groups
1152683|NCT00429299|B3|Baseline|CT Plus Trastuzumab and Lapatinib 1000 mg|Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach.
1152684|NCT00429299|B2|Baseline|CT Plus Lapatinib 1500 mg|Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach.
1152685|NCT00429299|B1|Baseline|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
1152686|NCT00429299|P3|Participant Flow|CT Plus Trastuzumab and Lapatinib 1000 mg|Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach.
1152687|NCT00429299|P2|Participant Flow|CT Plus Lapatinib 1500 mg|Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach.
1152688|NCT00429299|P1|Participant Flow|Chemotherapy (CT) Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
1153636|NCT00426283|E1|Reported Event|Flovent 1760 mcg|"Drug~Flovent : 1760 mcg daily"
1152689|NCT00429299|O3|Outcome|CT Plus Trastuzumab and Lapatinib 1000 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach."
1152729|NCT00429182|B1|Baseline|High-dose Chemotherapy|"Carboplatin + Cyclophosphamide + Thiotepa~Carboplatin : Target AUC of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.~Thiotepa : 120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.~Stem Cell Transplant : Stem Cell Transplant on Day 0.~Cyclophosphamide : 1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion."
1152875|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
1152690|NCT00429299|O2|Outcome|CT Plus Lapatinib 1500 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach."
1152691|NCT00429299|O1|Outcome|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
1152692|NCT00429299|O3|Outcome|CT Plus Trastuzumab and Lapatinib 1000 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach."
1152693|NCT00429299|O2|Outcome|CT Plus Lapatinib 1500 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach."
1152694|NCT00429299|O1|Outcome|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
1152695|NCT00429299|O3|Outcome|CT Plus Trastuzumab and Lapatinib 1000 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach."
1152696|NCT00429299|O2|Outcome|CT Plus Lapatinib 1500 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach."
1152697|NCT00429299|O1|Outcome|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
1152721|NCT00429273|P2|Participant Flow|Group 2: Placebo-Placebo+DMPH|weeks 1-4: Placebo weeks 5-8: Placebo+DMPH
1156437|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
1152698|NCT00429299|O3|Outcome|CT Plus Trastuzumab and Lapatinib 1000 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach."
1152699|NCT00429299|O2|Outcome|CT Plus Lapatinib 1500 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach."
1152774|NCT00428974|O3|Outcome|CF101 4 mg BID|Oral tablets given every 12 hours for 12 weeks
1163351|NCT00402987|O4|Outcome|Placebo|
1152700|NCT00429299|O1|Outcome|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
1152701|NCT00429299|O3|Outcome|CT Plus Trastuzumab and Lapatinib 1000 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach."
1152702|NCT00429299|O2|Outcome|CT Plus Lapatinib 1500 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach."
1152703|NCT00429299|O1|Outcome|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
1152704|NCT00429299|O3|Outcome|CT Plus Trastuzumab and Lapatinib 1000 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach."
1152705|NCT00429299|O2|Outcome|CT Plus Lapatinib 1500 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach."
1152706|NCT00429299|O1|Outcome|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
1152722|NCT00429273|P1|Participant Flow|Group 1: Guan-Guan+Placebo|weeks 1-4: Guanfacine weeks 5-8: Guanfacine+Placebo
1152758|NCT00429104|O1|Outcome|HER2+ Metastatic Breast Cancer|Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m^2 subcutaneously
1152759|NCT00429104|E1|Reported Event|HER2+ Metastatic Breast Cancer|Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m^2 subcutaneously
1152707|NCT00429299|O3|Outcome|CT Plus Trastuzumab and Lapatinib 1000 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach."
1152708|NCT00429299|O2|Outcome|CT Plus Lapatinib 1500 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach."
1152709|NCT00429299|O1|Outcome|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
1152876|NCT00428597|O2|Outcome|Placebo|Matching placebo.
1152710|NCT00429299|O3|Outcome|CT Plus Trastuzumab and Lapatinib 1000 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach."
1152711|NCT00429299|O2|Outcome|CT Plus Lapatinib 1500 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach."
1152712|NCT00429299|O1|Outcome|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
1152713|NCT00429299|E3|Reported Event|CT Plus Trastuzumab and Lapatinib 1000 mg|Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach.
1152714|NCT00429299|E2|Reported Event|CT Plus Lapatinib 1500 mg|Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach.
1152715|NCT00429299|E1|Reported Event|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
1152716|NCT00429273|B4|Baseline|Total|Total of all reporting groups
1152717|NCT00429273|B3|Baseline|Group 3: Guan-Guan+DMPH (Comb)|weeks 1-4: Guanfacine weeks 5-8: Guanfacine+DMPH (comb)
1152718|NCT00429273|B2|Baseline|Group 2: Placebo-Placebo+DMPH|weeks 1-4: Placebo weeks 5-8: Placebo+DMPH
1152719|NCT00429273|B1|Baseline|Group 1: Guan-Guan+Placebo|weeks 1-4: Guanfacine weeks 5-8: Guanfacine +Placebo
1152720|NCT00429273|P3|Participant Flow|Group 3: Guan-Guan+DMPH|weeks 1-4: Guanfacine weeks 5-8: Guanfacine+DMPH (comb)
1156438|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
1152723|NCT00429273|O3|Outcome|Estimated Difference Between Placebo and Combo|Contrasts based on all observations of patients treated with combo and all patients on placebo controlling for time effects. For placebo this included patients in the guan-guan arm at baseline, the guan-combo arm at baseline, and the placebo-DMPH arm at baseline and 4 weeks, while the estimates for DMPH are based on the guan-combo arm at 8 weeks. Participant specific effects and time effects are controlled for based on estimates from all participants and all time points.
1152724|NCT00429273|O2|Outcome|Estimated Difference Between DMPH and Placebo|Contrasts based on all observations of patients treated with dmph and all patients on placebo controlling for time effects. For placebo this included patients in the guan-guan arm at baseline, the guan-combo arm at baseline, and the placebo-DMPH arm at baseline and 4 weeks, while the estimates for DMPH are based on the placebo-guan arm at 8 weeks. Participant specific effects and time effects are controlled for based on estimates from all participants and all time points.
1152725|NCT00429273|O1|Outcome|Estimated Difference Between Guan and Placebo|Contrasts based on all observations of patients treated with guam and all patients on placebo controlling for time effects. For placebo this included patients in the guan-guan arm at baseline, the guan-combo arm at baseline, and the placebo-DMPH arm at baseline and 4 weeks, while the estimates for guan are based on the guan-guan arm both at 4 weeks and 8 weeks, and the guan-combo arm at 4 weeks only. Participant specific effects and time effects are controlled for based on estimates from all participants and all time points.
1152726|NCT00429273|E3|Reported Event|Group 3: Guan-Guan+DMPH|week 1-4: Guanfacine week 5-8: Guanfacine+DMPH (comb)
1152727|NCT00429273|E2|Reported Event|Group 2: Placebo-Placebo+DMPH|week 1-4: Placebo week 5-8: Placebo+DMPH
1152728|NCT00429273|E1|Reported Event|Group 1: Guan-Guan+Placebo|week 1-4: Guanfacine weeks 5-8: Guanfacine+Placebo
1152884|NCT00428597|O2|Outcome|Placebo|Matching placebo.
1152730|NCT00429182|P1|Participant Flow|High-dose Chemotherapy|"Carboplatin + Cyclophosphamide + Thiotepa~Carboplatin : Target area under the curve (AUC) of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.~Thiotepa : 120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.~Stem Cell Transplant : Stem Cell Transplant on Day 0.~Cyclophosphamide : 1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion."
1152731|NCT00429182|O1|Outcome|High-dose Chemotherapy|"Carboplatin + Cyclophosphamide + Thiotepa~Carboplatin : Target AUC of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.~Thiotepa : 120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.~Stem Cell Transplant : Stem Cell Transplant on Day 0.~Cyclophosphamide : 1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion."
1152732|NCT00429182|O1|Outcome|High-dose Chemotherapy|"Carboplatin + Cyclophosphamide + Thiotepa~Carboplatin : Target AUC of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.~Thiotepa : 120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.~Stem Cell Transplant : Stem Cell Transplant on Day 0.~Cyclophosphamide : 1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion."
1152733|NCT00429182|E1|Reported Event|High-dose Chemotherapy|"Carboplatin + Cyclophosphamide + Thiotepa~Carboplatin : Target AUC of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.~Thiotepa : 120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.~Stem Cell Transplant : Stem Cell Transplant on Day 0.~Cyclophosphamide : 1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion."
1152734|NCT00429169|B3|Baseline|Total|Total of all reporting groups
1152735|NCT00429169|B2|Baseline|Bupropion|Participants will receive bupropion for 8 weeks
1152736|NCT00429169|B1|Baseline|Paroxetine|Participants will receive paroxetine for 8 weeks
1152737|NCT00429169|P2|Participant Flow|Bupropion|Participants will receive bupropion for 8 weeks
1152738|NCT00429169|P1|Participant Flow|Paroxetine|Participants will receive paroxetine for 8 weeks
1152739|NCT00429169|O2|Outcome|Bupropion|Participants will receive bupropion for 8 weeks
1152740|NCT00429169|O1|Outcome|Paroxetine|Participants will receive paroxetine for 8 weeks
1152741|NCT00429169|O2|Outcome|Bupropion|Bupropion acute treatment for 8 weeks.
1152742|NCT00429169|O1|Outcome|Paroxetine|Paroxetine acute treatment for 8 weeks.
1152743|NCT00429169|O2|Outcome|Bupropion|Participants will receive bupropion for 8 weeks
1152744|NCT00429169|O1|Outcome|Paroxetine|Participants will receive paroxetine for 8 weeks
1152745|NCT00429169|E2|Reported Event|Bupropion|Participants will receive bupropion for 8 weeks
1152746|NCT00429169|E1|Reported Event|Paroxetine|Participants will receive paroxetine for 8 weeks
1152747|NCT00429143|B1|Baseline|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
1152748|NCT00429143|P1|Participant Flow|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
1152749|NCT00429143|O1|Outcome|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
1152750|NCT00429143|O1|Outcome|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
1152751|NCT00429143|O1|Outcome|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
1152752|NCT00429143|O1|Outcome|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
1152753|NCT00429143|O1|Outcome|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
1152754|NCT00429143|E1|Reported Event|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
1152755|NCT00429104|B1|Baseline|HER2+ Metastatic Breast Cancer|Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m^2 subcutaneously
1152756|NCT00429104|P1|Participant Flow|HER2+ Metastatic Breast Cancer|Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m^2 subcutaneously
1152757|NCT00429104|O1|Outcome|HER2+ Metastatic Breast Cancer|Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m^2 subcutaneously
1156439|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
1152763|NCT00429026|E1|Reported Event|Conditioning Regimen|Chemotherapy including combinations of Fludarabine, Melphalan, Cyclophosphamide
1152764|NCT00428974|B5|Baseline|Total|Total of all reporting groups
1152765|NCT00428974|B4|Baseline|Placebo|Oral tablets given every 12 hours for 12 weeks
1152766|NCT00428974|B3|Baseline|CF101 4 mg BID|Oral tablets given every 12 hours for 12 weeks
1152767|NCT00428974|B2|Baseline|CF101 2 mg BID|Oral tablets given every 12 hours for 12 weeks
1152768|NCT00428974|B1|Baseline|CF101 1 mg Twice Daily (BID)|Oral tablets given every 12 hours for 12 weeks
1152769|NCT00428974|P4|Participant Flow|Placebo|Oral tablets given every 12 hours for 12 weeks
1152770|NCT00428974|P3|Participant Flow|CF101 4 mg BID|Oral tablets given every 12 hours for 12 weeks
1152771|NCT00428974|P2|Participant Flow|CF101 2 mg BID|Oral tablets given every 12 hours for 12 weeks
1152772|NCT00428974|P1|Participant Flow|CF101 1 mg Twice Daily (BID)|Oral tablets given every 12 hours for 12 weeks
1152773|NCT00428974|O4|Outcome|Placebo|Oral tablets given every 12 hours for 12 weeks
1152787|NCT00428922|O1|Outcome|Trastuzumab, Bevacizumab, and Docetaxel|Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]
1152788|NCT00428922|O1|Outcome|Trastuzumab, Bevacizumab, and Docetaxel|Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]
1152789|NCT00428922|O1|Outcome|Trastuzumab, Bevacizumab, and Docetaxel|Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]
1152790|NCT00428922|O1|Outcome|Trastuzumab, Bevacizumab, and Docetaxel|Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]
1152791|NCT00428922|E1|Reported Event|Trastuzumab, Bevacizumab, and Docetaxel|Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]
1152792|NCT00428844|B4|Baseline|Total|Total of all reporting groups
1152793|NCT00428844|B3|Baseline|Comparator|Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
1152794|NCT00428844|B2|Baseline|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
1152795|NCT00428844|B1|Baseline|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
1152796|NCT00428844|P3|Participant Flow|Comparator|Vancomycin was administered at 1 gram (gm)every 12 hours (q12h) as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
1152797|NCT00428844|P2|Participant Flow|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30 minute IV infusion for 6 weeks (± one week).
1152798|NCT00428844|P1|Participant Flow|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg every 24 hours [q24h]) as a 30 minute intravenous (IV) infusion for 6 weeks (± one week).
1152799|NCT00428844|O2|Outcome|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
1152800|NCT00428844|O1|Outcome|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
1152801|NCT00428844|O2|Outcome|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
1152802|NCT00428844|O1|Outcome|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
1152803|NCT00428844|O3|Outcome|Comparator|Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
1152804|NCT00428844|O2|Outcome|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
1152805|NCT00428844|O1|Outcome|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
1152806|NCT00428844|O3|Outcome|Comparator|Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
1152807|NCT00428844|O2|Outcome|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
1152808|NCT00428844|O1|Outcome|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
1152809|NCT00428844|O3|Outcome|Comparator|Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
1152810|NCT00428844|O2|Outcome|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
1152811|NCT00428844|O1|Outcome|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
1152812|NCT00428844|O3|Outcome|Comparator|Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
1152813|NCT00428844|O2|Outcome|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
1152814|NCT00428844|O1|Outcome|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
1152815|NCT00428844|E3|Reported Event|Comparator|Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
1152816|NCT00428844|E2|Reported Event|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
1152817|NCT00428844|E1|Reported Event|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
1152818|NCT00428792|B3|Baseline|Total|Total of all reporting groups
1155163|NCT00423683|E2|Reported Event|Arixtra Alone|Arixtra anti coagulation alone
1152819|NCT00428792|B2|Baseline|Standard Breakfast (SB) Then Very Light Breakfast (VLB)|Standard breakfast (SB) for one week then crossover to very light breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
1152820|NCT00428792|B1|Baseline|Very Light Breakfast (VLB) Then Standard Breakfast (SB)|Very light breakfast (VLB) for one week then crossover to standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
1152877|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
1152878|NCT00428597|O2|Outcome|Placebo|Matching placebo.
1152879|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
1152821|NCT00428792|P2|Participant Flow|Standard Breakfast (SB) Then Very Light Breakfast (VLB)|Standard breakfast (SB) for one week then crossover to very light breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
1152822|NCT00428792|P1|Participant Flow|Very Light Breakfast (VLB) Then Standard Breakfast (SB)|Very light breakfast (VLB) for one week then crossover to standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
1152823|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
1152824|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
1152825|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
1152826|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
1152827|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
1152828|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
1152829|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
1152830|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
1152831|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
1152832|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
1152859|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
1152860|NCT00428597|O2|Outcome|Placebo|Matching placebo.
1156440|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
1152833|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
1152834|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
1152835|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
1152880|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
1152881|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
1152836|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
1152837|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
1152838|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
1152839|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
1152840|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
1152841|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
1152842|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
1152843|NCT00428792|E2|Reported Event|Standard Breakfast (SB) Then Very Light Breakfast (VLB)|Standard breakfast (SB) for one week then crossover to very light breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
1152844|NCT00428792|E1|Reported Event|Very Light Breakfast (VLB) Then Standard Breakfast (SB)|Very light breakfast (VLB) for one week then crossover to standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
1152845|NCT00428597|B3|Baseline|Total|Total of all reporting groups
1152846|NCT00428597|B2|Baseline|Placebo|Matching placebo.
1152847|NCT00428597|B1|Baseline|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
1152848|NCT00428597|P2|Participant Flow|Placebo|Matching placebo.
1152849|NCT00428597|P1|Participant Flow|Sunitinib|Oral sunitinib 37.5 milligrams (mg) once daily on a continuous daily dosing schedule.
1152850|NCT00428597|O2|Outcome|Placebo|Matching placebo.
1152851|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
1152852|NCT00428597|O2|Outcome|Placebo|Matching placebo.
1152853|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
1152854|NCT00428597|O2|Outcome|Placebo|Matching placebo.
1152855|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
1152856|NCT00428597|O2|Outcome|Placebo|Matching placebo.
1152857|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
1152858|NCT00428597|O2|Outcome|Placebo|Matching placebo.
1152861|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
1152862|NCT00428597|O2|Outcome|Placebo|Matching placebo.
1152863|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
1152864|NCT00428597|O2|Outcome|Placebo|Matching placebo.
1152865|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
1152866|NCT00428597|O2|Outcome|Placebo|Matching placebo.
1152867|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
1152868|NCT00428597|O2|Outcome|Placebo|Matching placebo.
1152869|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
1152870|NCT00428597|O2|Outcome|Placebo|Matching placebo.
1152871|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
1152872|NCT00428597|O2|Outcome|Placebo|Matching placebo.
1152873|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
1152874|NCT00428597|O2|Outcome|Placebo|Matching placebo.
1152885|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
1152886|NCT00428597|E2|Reported Event|Placebo|Matching placebo.
1152887|NCT00428597|E1|Reported Event|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
1152888|NCT00428584|B3|Baseline|Total|Total of all reporting groups
1152889|NCT00428584|B2|Baseline|Betaseron|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
1152890|NCT00428584|B1|Baseline|New Formulation of Rebif|Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
1152891|NCT00428584|P2|Participant Flow|Betaseron|
1152892|NCT00428584|P1|Participant Flow|New Formulation of Rebif|The new formulation of rebif is not approved and under investigation in the US
1152893|NCT00428584|O2|Outcome|Betaseron to the New Formulation of Rebif|
1152894|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, Rebif (New Formulation) 44 mcg, subcutaneous injection, three times a week
1152895|NCT00428584|O2|Outcome|Betaseron to the New Formulation of Rebif|
1152896|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, Rebif (New Formulation) 44 mcg, subcutaneous injection, three times a week
1152897|NCT00428584|O2|Outcome|Betaseron to the New Formulation of Rebif|
1152898|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, Rebif (New Formulation) 44 mcg, subcutaneous injection, three times a week
1152899|NCT00428584|O2|Outcome|Betaseron to the New Formulation of Rebif|
1152900|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, Rebif (New Formulation) 44 mcg, subcutaneous injection, three times a week
1152901|NCT00428584|O2|Outcome|Betaseron to New Formulation of Rebif|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
1152902|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, new formualation of rebif- 44 mcg, subcutaneous injection, three times a week
1152903|NCT00428584|O2|Outcome|Betaseron|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
1152904|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
1152905|NCT00428584|O2|Outcome|Betaseron|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
1152906|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
1152907|NCT00428584|O2|Outcome|Betaseron|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
1152908|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
1152909|NCT00428584|O2|Outcome|Betaseron|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
1152910|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
1152911|NCT00428584|O2|Outcome|Betaseron|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
1152912|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
1152913|NCT00428584|E2|Reported Event|Betaseron|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
1152914|NCT00428584|E1|Reported Event|New Formulation of Rebif|Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
1152915|NCT00428441|B1|Baseline|D-dimer Negative|patients with recurrent venous thrombosis and negative D-dimer at the time of enrolment
1152916|NCT00428441|P1|Participant Flow|D-dimer Negative|patients with recurrent venous thrombosis and negative D-dimer at the time of enrolment
1152917|NCT00428441|O1|Outcome|D-dimer Negative|patients with recurrent venous thrombosis and negative D-dimer at the time of enrolment
1152918|NCT00428441|E1|Reported Event|D-dimer Negative|patients with recurrent venous thrombosis and negative D-dimer at the time of enrolment
1152919|NCT00428389|B3|Baseline|Total|Total of all reporting groups
1152920|NCT00428389|B2|Baseline|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
1152940|NCT00428298|B3|Baseline|Total|Total of all reporting groups
1152941|NCT00428298|B2|Baseline|Placebo Treatment|Placebo: Subjects take two 500 mg capsules twice daily for 16 weeks.
1155164|NCT00423683|E1|Reported Event|2 Arixtra+ Filter|Arixtra subq injection + IVC filter
1152921|NCT00428389|B1|Baseline|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
1152922|NCT00428389|P2|Participant Flow|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
1152956|NCT00428246|B1|Baseline|1|1 mcg paricalcitol
1152957|NCT00428246|P3|Participant Flow|3|Placebo
1152958|NCT00428246|P2|Participant Flow|2|2 mcg paricalcitol
1152923|NCT00428389|P1|Participant Flow|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
1152924|NCT00428389|O2|Outcome|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
1152925|NCT00428389|O1|Outcome|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
1152926|NCT00428389|O2|Outcome|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
1152927|NCT00428389|O1|Outcome|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
1152928|NCT00428389|O2|Outcome|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
1152929|NCT00428389|O1|Outcome|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
1152942|NCT00428298|B1|Baseline|Active Treatment Valacyclovir|Valacyclovir: Subjects take two 500 mg capsules twice daily for 16 weeks.
1152943|NCT00428298|P2|Participant Flow|Placebo Treatment|Placebo: Subjects take two 500 mg capsules twice daily for 16 weeks.
1152944|NCT00428298|P1|Participant Flow|Active Treatment Valacyclovir|Valacyclovir: Subjects take two 500 mg capsules twice daily for 16 weeks.
1152930|NCT00428389|O2|Outcome|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
1152931|NCT00428389|O1|Outcome|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
1152932|NCT00428389|O2|Outcome|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
1152933|NCT00428389|O1|Outcome|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
1152934|NCT00428389|O2|Outcome|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
1152935|NCT00428389|O1|Outcome|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
1152936|NCT00428389|O2|Outcome|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
1152937|NCT00428389|O1|Outcome|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
1152938|NCT00428389|E2|Reported Event|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
1152939|NCT00428389|E1|Reported Event|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
1152945|NCT00428298|O2|Outcome|Inactive Treatment Group - Placebo|Subjects dispensed 500 mg capsules. Subjects take two 500 mg capsules twice daily for 16 weeks.
1152946|NCT00428298|O1|Outcome|Active Treatment Group - Valcyclovir|Subjects dispensed 500 mg capsules. Subjects take two 500 mg capsules twice daily for 16 weeks.
1152947|NCT00428298|O2|Outcome|Inactive Treatment Group - Placebo|Subjects dispensed 500 mg capsules. Subjects take two 500 mg capsules twice daily for 16 weeks.
1152948|NCT00428298|O1|Outcome|Active Treatment Group - Valcyclovir|Subjects dispensed 500 mg capsules. Subjects take two 500 mg capsules twice daily for 16 weeks.
1152949|NCT00428298|O2|Outcome|Placebo Treatment|Placebo: Subjects take two 500 mg capsules twice daily for 16 weeks.
1152950|NCT00428298|O1|Outcome|Active Treatment Valacyclovir|Valacyclovir: Subjects take two 500 mg capsules twice daily for 16 weeks.
1152951|NCT00428298|E2|Reported Event|Placebo Treatment|Placebo: Subjects take two 500 mg capsules twice daily for 16 weeks.
1152952|NCT00428298|E1|Reported Event|Active Treatment Valacyclovir|Valacyclovir: Subjects take two 500 mg capsules twice daily for 16 weeks.
1152953|NCT00428246|B4|Baseline|Total|Total of all reporting groups
1152954|NCT00428246|B3|Baseline|3|Placebo
1152955|NCT00428246|B2|Baseline|2|2 mcg paricalcitol
1152966|NCT00428220|B1|Baseline|Sunitinib|Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
1152967|NCT00428220|P1|Participant Flow|Sunitinib|Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
1152968|NCT00428220|O11|Outcome|Sunitinib 11|Parent Study: A6181170
1152969|NCT00428220|O10|Outcome|Sunitinib 10|Parent Study: A6181126
1152970|NCT00428220|O9|Outcome|Sunitinib 9|Parent Study: A6181120
1152971|NCT00428220|O8|Outcome|Sunitinib 8|Parent Study: A6181113
1152972|NCT00428220|O7|Outcome|Sunitinib 7|Parent Study: A6181112
1152973|NCT00428220|O6|Outcome|Sunitinib 6|Parent Study: A6181111
1152974|NCT00428220|O5|Outcome|Sunitinib 5|Parent Study: A6181110
1152975|NCT00428220|O4|Outcome|Sunitinib 4|Parent Study: A6181107
1152976|NCT00428220|O3|Outcome|Sunitinib 3|Parent Study: A6181094
1152977|NCT00428220|O2|Outcome|Sunitinib 2|Parent Study: A6181087
1152978|NCT00428220|O1|Outcome|Sunitinib 1|Parent Study: A6181078
1152979|NCT00428220|O1|Outcome|Sunitinib|Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
1152980|NCT00428220|O1|Outcome|Sunitinib|Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
1152981|NCT00428220|E1|Reported Event|Sunitinib|Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
1152982|NCT00428207|B1|Baseline|Insulin Aspart Versus Insulin Lispro|"insulin Aspart versus insulin Lispro : Subjects will be randomly assigned to one of the two insulins by the statistician working in the study via random number generation. Half of the patients will begin with insulin aspart, and then will be crossed over to insulin lispro. The insulin sequence will be reversed for the other half of the patients.~Period 1: four weeks using insulin aspart in the pump, followed by Period 2: four weeks using insulin lispro in the pump, or vice versa depending on randomization.~insulin pump :"
1152983|NCT00428207|P2|Participant Flow|Insulin Aspart|"Subjects will be randomly assigned to one of the two insulins (insulin Aspart) by the statistician working in the study via random number generation.~First Intervention- four weeks using insulin Aspart in the pump. Subjects will use their current basal rates, insulin to carb ratios and correction factors to dose insulin.~After the four weeks of the first intervention have been completed subjects will be switched to insulin lispro, for the second intervention period.~The sequence of interventions may be reversed due to random assignment of treatment."
1152984|NCT00428207|P1|Participant Flow|Insulin Lispro|"Subjects will be randomly assigned to one of the two insulins (insulin Lispro) by the statistician working in the study via random number generation.~First Intervention- four weeks using insulin Aspart in the pump. Subjects will use their current basal rates, insulin to carb ratios and correction factors to dose insulin.~After the four weeks of the first intervention have been completed subjects will be switched to insulin lispro, for the second intervention period.~The sequence of interventions may be reversed due to random assignment of treatment."
1152985|NCT00428207|O1|Outcome|Insulin Aspart Versus Insulin Lispro|"insulin Aspart versus insulin Lispro : Subjects will be randomly assigned to one of the two insulins by the statistician working in the study via random number generation. Half of the patients will begin with insulin aspart, and then will be crossed over to insulin lispro. The insulin sequence will be reversed for the other half of the patients.~Period 1: four weeks using insulin aspart in the pump, followed by Period 2: four weeks using insulin lispro in the pump, or vice versa depending on randomization.~insulin pump :"
1153179|NCT00427934|B4|Baseline|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1152986|NCT00428207|O2|Outcome|Insulin Lispro Versus Insulin Aspart|"Insulin lispro will be used for diabetes management, and will be delivered continuously, subcutaneously using a pump for a four week period. Dose will be adjusted as needed to maintain glycemic control. Insulin dose adjustments will vary from patient to patient based on the carbohydrate consumption, level of physical activity, and fingerstick monitoring results SMBG (7 times per day). SMBG results collected during this four week period will be compared to the SMBG results collected while participant uses alternative treatment (insulin Aspart).~Insulin Lispro versus Insulin Aspart: Subjects will be randomly assigned to insulin lispro versus insulin aspart via random number generation. Half of the patients will begin with insulin lispro, and then will be crossed over to insulin aspart. The insulin sequence will be reversed for the other half of the patients."
1153011|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153012|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153195|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1152987|NCT00428207|O1|Outcome|Insulin Aspart Versus Insulin Lispro|"Insulin aspart will be used for diabetes management, and will be delivered continuously, subcutaneously using a pump for a four week period. Insulin aspart doses will be adjusted by the principal investigator as needed to maintain glycemic control. Insulin dose adjustments will vary from patient to patient based on the carbohydrate consumption, level of physical activity, and fingerstick monitoring results SMBG (7 times per day). SMBG results collected during this four week period will be compared to the SMBG results collected while participant uses alternative treatment (insulin Lispro).~Insulin Aspart versus Insulin Lispro: Subjects will be randomly assigned to insulin aspart versus insulin lispro via random number generation. Half of the patients will begin with insulin aspart, and then will be crossed over to insulin lispro. The insulin sequence will be reversed for the other half of the patients."
1152988|NCT00428207|E1|Reported Event|Insulin Aspart Versus Insulin Lispro|"insulin Aspart versus insulin Lispro : Subjects will be randomly assigned to one of the two insulins by the statistician working in the study via random number generation. Half of the patients will begin with insulin aspart, and then will be crossed over to insulin lispro. The insulin sequence will be reversed for the other half of the patients.~Period 1: four weeks using insulin aspart in the pump, followed by Period 2: four weeks using insulin lispro in the pump, or vice versa depending on randomization."
1152989|NCT00428116|B3|Baseline|Total|Total of all reporting groups
1152990|NCT00428116|B2|Baseline|Interrupted HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
1152991|NCT00428116|B1|Baseline|Continued HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to continued treatment with HAART for 18 months.
1152992|NCT00428116|P2|Participant Flow|Interrupted HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
1152993|NCT00428116|P1|Participant Flow|Continued HAART|After 24 months of HAART, infants were continued on HAART.
1152994|NCT00428116|O2|Outcome|Interrupted HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
1152995|NCT00428116|O1|Outcome|Continue HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to continued treatment with HAART for 18 months.
1152996|NCT00428116|O2|Outcome|Interrupted HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
1152997|NCT00428116|O1|Outcome|Continued HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to continued treatment with HAART for 18 months.
1152998|NCT00428116|E2|Reported Event|Interrupted HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
1152999|NCT00428116|E1|Reported Event|Continued HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to continued treatment with HAART for 18 months.
1153000|NCT00428090|B5|Baseline|Total|Total of all reporting groups
1153001|NCT00428090|B4|Baseline|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153002|NCT00428090|B3|Baseline|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153003|NCT00428090|B2|Baseline|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153004|NCT00428090|B1|Baseline|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153005|NCT00428090|P4|Participant Flow|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153006|NCT00428090|P3|Participant Flow|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153007|NCT00428090|P2|Participant Flow|RSG XR 2 mg|Par. in this arm received rosiglitazone extended release (RSGXR) 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153008|NCT00428090|P1|Participant Flow|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153009|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153010|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153186|NCT00427934|P1|Participant Flow|Maraviroc 150 mg BID (Pharmacokinetic [PK])|150 mg tablet was administered by mouth twice a day (BID) for 4 weeks with stable weekly doses of methotrexate (MTX).
1153454|NCT00426842|O1|Outcome|No-drug|
1153013|NCT00428090|O4|Outcome|Donepezil 10 mg|Par.in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153014|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153015|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153016|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153017|NCT00428090|O4|Outcome|Donepezil 10 mg|Par.in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153018|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153019|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153020|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153021|NCT00428090|O4|Outcome|Donepezil 10 mg|Par.in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153022|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153023|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153024|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153025|NCT00428090|O4|Outcome|Donepezil 10 mg|Par.in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153026|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153027|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153028|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153180|NCT00427934|B3|Baseline|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1155165|NCT00423670|B8|Baseline|Total|Total of all reporting groups
1153029|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153030|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153031|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153032|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153033|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153187|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
1153034|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153035|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153036|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153037|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153038|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153039|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153040|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153041|NCT00428090|O4|Outcome|Donepezil 10 mg|Par.in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153042|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153043|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153044|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153045|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153046|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153047|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153048|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153049|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4Wof treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153050|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153051|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153052|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153053|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153054|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153188|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
1153055|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153056|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153057|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153058|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153059|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153060|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153061|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153062|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153063|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153064|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153065|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153066|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153067|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153068|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153069|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153133|NCT00427999|E1|Reported Event|STI571+Pioglitazone+Etoricoxib+Dexamethasone+Treosulfane(Core)|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks (Core)
1156441|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
1153070|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153071|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153072|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153073|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153074|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153075|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153189|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
1153076|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153077|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153078|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153079|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153080|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153081|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153082|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153083|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153084|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153085|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153086|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153087|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153088|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153089|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153165|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
1153166|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
1153167|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
1153168|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
1153090|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4W of treatment. From Visit 4 (W4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153091|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153092|NCT00428090|O1|Outcome|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153093|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. randomized to this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153094|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. randomized to this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153095|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. randomized to this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153096|NCT00428090|O1|Outcome|Placebo|Par. randomized to this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153190|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
1153097|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. randomized to this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153098|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. randomized to this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153099|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. randomized to this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153100|NCT00428090|O1|Outcome|Placebo|Par. randomized to this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153101|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. randomized to this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153102|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. randomized to this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153103|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. randomized to this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153104|NCT00428090|O1|Outcome|Placebo|Par. randomized to this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153105|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. randomized to this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153106|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. randomized to this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153107|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. randomized to this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153108|NCT00428090|O1|Outcome|Placebo|Par. randomized to this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153109|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. randomized to this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153169|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
1153170|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
1153110|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. randomized to this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153111|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. randomized to this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153112|NCT00428090|O1|Outcome|Placebo|Par. randomized to this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153113|NCT00428090|O4|Outcome|Donepezil 10 mg|Par. randomized to this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153114|NCT00428090|O3|Outcome|RSG XR 8 mg|Par. randomized to this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153115|NCT00428090|O2|Outcome|RSG XR 2 mg|Par. randomized to this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153116|NCT00428090|O1|Outcome|Placebo|Par. randomized to this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153191|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
1156285|NCT00421993|O1|Outcome|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
1153117|NCT00428090|E4|Reported Event|Donepezil 10 mg|Par. in this arm received donepezil 5 mg capsule along with dummy RSGXR tablet once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received donepezil 10 mg capsule along with dummy RSGXR tablet once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153118|NCT00428090|E3|Reported Event|RSG XR 8 mg|Par. in this arm received RSGXR 4 mg tablet along with dummy donepezil capsule once daily for the first 4 weeks of treatment. From Visit 4 (Week 4) onwards, these par. received 8 mg RSGXR tablet along with dummy donepezil capsule once daily for the remaining 20W of double-blind treatment. Study treatment were taken in the evening with or without food.
1153119|NCT00428090|E2|Reported Event|RSG XR 2 mg|Par. in this arm received RSGXR 2 milligram (mg) tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153120|NCT00428090|E1|Reported Event|Placebo|Par. in this arm received RSG placebo tablet along with dummy donepezil capsule once daily for 24W. For par. in this arm, the dosage were remain constant throughout the 24W treatment period. Study treatment were taken in the evening with or without food.
1153121|NCT00428077|B1|Baseline|Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL)|Patients will be vaccinated 15 times over 12 months with a vaccine comprised of native and synthetic BCR-ABL (break-point cluster region-Abelson murine leukemia) specific peptides and the immunologic adjuvants, Montanide ISA 51-VG.
1153122|NCT00428077|P1|Participant Flow|Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL)|Patients will be vaccinated 15 times over 12 months with a vaccine comprised of native and synthetic BCR-ABL (break-point cluster region-Abelson murine leukemia) specific peptides and the immunologic adjuvants, Montanide ISA 51-VG.
1153123|NCT00428077|O1|Outcome|Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL)|Patients with Philadelphia Chromosome (Ph+) or Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL),positive Chronic Myeloid Leukemia(CML), in cytogenetic remission, with minimal residual disease.
1153124|NCT00428077|E1|Reported Event|Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL)|Patients will be vaccinated 15 times over 12 months with a vaccine comprised of native and synthetic BCR-ABL (break-point cluster region-Abelson murine leukemia) specific peptides and the immunologic adjuvants, Montanide ISA 51-VG.
1153125|NCT00427999|B1|Baseline|STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
1153126|NCT00427999|P1|Participant Flow|STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
1153127|NCT00427999|O1|Outcome|STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
1153128|NCT00427999|O1|Outcome|STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
1153129|NCT00427999|O1|Outcome|STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
1153130|NCT00427999|O1|Outcome|STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
1153131|NCT00427999|O1|Outcome|STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
1153132|NCT00427999|E2|Reported Event|STI571+Pioglitazone+Etoricoxib+Dexamethasone+Treosulfane(Ext)|Extension follow-up
1153134|NCT00427973|B1|Baseline|Singe Arm Open Label Study With AZD2171 at 30 mg Daily|"Patients will receive AZD2171 (cediranib maleate) by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.~cediranib maleate: Given orally~laboratory biomarker analysis~computed tomography~dynamic contrast-enhanced magnetic resonance imaging~pharmacological study"
1153135|NCT00427973|P1|Participant Flow|Singe Arm Open Label Study With AZD2171 at 30 mg Daily.|Patients will receive AZD2171 by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies.
1153136|NCT00427973|O1|Outcome|Singe Arm Open Label Study With AZD2171 at 30 mg Daily|"Patients will receive AZD2171 (cediranib maleate) by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.~cediranib maleate: Given orally~laboratory biomarker analysis~computed tomography~dynamic contrast-enhanced magnetic resonance imaging~pharmacological study"
1153192|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
1153193|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153194|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1156286|NCT00421993|O4|Outcome|Gel Vehicle|Topical Gel Vehicle
1153137|NCT00427973|O1|Outcome|Singe Arm Open Label Study With AZD2171 at 30 mg Daily|"Patients will receive AZD2171 (cediranib maleate) by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.~cediranib maleate: Given orally~laboratory biomarker analysis~computed tomography~dynamic contrast-enhanced magnetic resonance imaging~pharmacological study"
1153138|NCT00427973|O1|Outcome|Singe Arm Open Label Study With AZD2171 at 30 mg Daily|"Patients will receive AZD2171 (cediranib maleate) by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.~cediranib maleate: Given orally~laboratory biomarker analysis~computed tomography~dynamic contrast-enhanced magnetic resonance imaging~pharmacological study"
1153139|NCT00427973|O1|Outcome|Singe Arm Open Label Study With AZD2171 at 30 mg Daily|"Patients will receive AZD2171 (cediranib maleate) by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.~cediranib maleate: Given orally~laboratory biomarker analysis~computed tomography~dynamic contrast-enhanced magnetic resonance imaging~pharmacological study"
1153140|NCT00427973|E1|Reported Event|Singe Arm Open Label Study With AZD2171 at 30 mg Daily|"Patients will receive AZD2171 (cediranib maleate) at 30 mg by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.~cediranib maleate: Given orally~laboratory biomarker analysis~computed tomography~dynamic contrast-enhanced magnetic resonance imaging~pharmacological study"
1153141|NCT00427960|B3|Baseline|Total|Total of all reporting groups
1153142|NCT00427960|B2|Baseline|Atorvastatin|atorvastatin 10 mg
1153143|NCT00427960|B1|Baseline|Rosuvastatin|rosuvastatin 5 mg
1153144|NCT00427960|P2|Participant Flow|Atorvastatin|atorvastatin 10 mg
1153145|NCT00427960|P1|Participant Flow|Rosuvastatin|rosuvastatin 5 mg
1153146|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
1153147|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
1153148|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
1153149|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
1153150|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
1153151|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
1153152|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
1153153|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
1153154|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
1153155|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
1153156|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
1153157|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
1153158|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
1153159|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
1153160|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
1153161|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
1153162|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
1153163|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
1153164|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
1153181|NCT00427934|B2|Baseline|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
1153182|NCT00427934|B1|Baseline|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
1153183|NCT00427934|P4|Participant Flow|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153184|NCT00427934|P3|Participant Flow|Maraviroc 300 mg BID (Proof-of-Concept [POC])|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153185|NCT00427934|P2|Participant Flow|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
1153196|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153197|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153198|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153199|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153200|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153201|NCT00427934|O4|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153202|NCT00427934|O3|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153203|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
1153204|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
1153205|NCT00427934|O4|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153206|NCT00427934|O3|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153207|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
1153208|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
1153209|NCT00427934|O4|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153210|NCT00427934|O3|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153211|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
1153212|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
1153213|NCT00427934|O4|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153214|NCT00427934|O3|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153215|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
1153216|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
1153217|NCT00427934|O4|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153218|NCT00427934|O3|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153219|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
1153220|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
1153221|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153222|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153223|NCT00427934|O4|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153224|NCT00427934|O3|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153225|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
1153226|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
1153227|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153228|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153229|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153230|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153231|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153232|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153233|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153234|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153235|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153236|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153237|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153238|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153239|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153240|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153241|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153242|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153243|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153244|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153245|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153246|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153247|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153248|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153249|NCT00427934|E4|Reported Event|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153250|NCT00427934|E3|Reported Event|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
1153251|NCT00427934|E2|Reported Event|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
1153252|NCT00427934|E1|Reported Event|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
1153253|NCT00427921|B1|Baseline|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
1153254|NCT00427921|P1|Participant Flow|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
1153255|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
1153256|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
1153257|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
1153258|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
1153259|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
1153260|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
1153261|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
1153262|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
1153263|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
1153264|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
1153265|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
1153266|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
1153267|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
1153268|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
1153269|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
1153270|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
1153271|NCT00427921|E1|Reported Event|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
1153272|NCT00427895|B5|Baseline|Total|Total of all reporting groups
1163352|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
1153273|NCT00427895|B4|Baseline|13vPnC, Cohort 3|Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
1153274|NCT00427895|B3|Baseline|13vPnC, Cohort 2|Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
1153275|NCT00427895|B2|Baseline|23vPS, Cohort 1|Participants aged 60-64 years old received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
1153276|NCT00427895|B1|Baseline|13vPnC, Cohort 1|Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]).
1153277|NCT00427895|P8|Participant Flow|13vPnC/13vPnC, Cohort 2|Participants 50-59 years of age who received 13vPnC at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 13vPnC (Vaccination 2) at Year 3 to 4.
1153278|NCT00427895|P7|Participant Flow|23vPS/23vPS, Cohort 1|Participants 60-64 years of age who received 23vPS at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 23vPS (Vaccination 2) at Year 3 to 4.
1153279|NCT00427895|P6|Participant Flow|13vPnC/23vPS, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 23vPS (Vaccination 2) at Year 3 to 4.
1153280|NCT00427895|P5|Participant Flow|13vPnC/13vPnC, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 13vPnC (Vaccination 2) at Year 3 to 4.
1153281|NCT00427895|P4|Participant Flow|13vPnC, Cohort 3|Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1) at baseline.
1153282|NCT00427895|P3|Participant Flow|13vPnC, Cohort 2|Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly at (Vaccination 1) at baseline.
1153283|NCT00427895|P2|Participant Flow|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1) at baseline.
1153284|NCT00427895|P1|Participant Flow|13vPnC, Cohort 1|Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]) at baseline.
1153285|NCT00427895|O4|Outcome|13vPnC/13vPnC, Cohort 2|Participants 50-59 years of age who received 13vPnC at vaccination 1 received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.
1153286|NCT00427895|O3|Outcome|13vPnC/23vPS, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose of open-label 23vPS (Vaccination 2) at Year 3 to 4.
1153287|NCT00427895|O2|Outcome|23vPS/23vPS, Cohort 1|Participants 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
1153288|NCT00427895|O1|Outcome|13vPnC/13vPnC, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2 [Vax2]) at Year 3 to 4.
1153289|NCT00427895|O4|Outcome|13vPnC, Cohort 3|Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
1153290|NCT00427895|O3|Outcome|13vPnC, Cohort 2|Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose at (Vaccination 1) Year 0.
1153291|NCT00427895|O2|Outcome|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose (Vaccination 1) at Year 0.
1153292|NCT00427895|O1|Outcome|13vPnC, Cohort 1|Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]) at Year 0.
1153293|NCT00427895|O4|Outcome|13vPnC/13vPnC, Cohort 2|Participants 50-59 years of age who received 13vPnC at vaccination 1 received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.
1153294|NCT00427895|O3|Outcome|13vPnC/23vPS, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
1153295|NCT00427895|O2|Outcome|23vPS/23vPS, Cohort 1|Participants aged 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
1153296|NCT00427895|O1|Outcome|13vPnC/13vPnC, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2 [Vax2]) at Year 3 to 4.
1153297|NCT00427895|O4|Outcome|13vPnC, Cohort 3|Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
1153298|NCT00427895|O3|Outcome|13vPnC, Cohort 2|Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose at (Vaccination 1).
1153299|NCT00427895|O2|Outcome|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose (Vaccination 1).
1153300|NCT00427895|O1|Outcome|13vPnC, Cohort 1|Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]).
1153301|NCT00427895|O4|Outcome|13vPnC/13vPnC, Cohort 2|Participants 50-59 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.
1153591|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
1153302|NCT00427895|O3|Outcome|23vPs/23vPS, Cohort 1|Participants 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
1153303|NCT00427895|O2|Outcome|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
1153304|NCT00427895|O1|Outcome|13vPnC/23vPS, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
1153305|NCT00427895|O4|Outcome|13vPnC/13vPnC, Cohort 2|Participants 50-59 years of age who received 13vPnC at vaccination 1 received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.
1153455|NCT00426842|E1|Reported Event|All Participants|Blood pressure response during HUT following administration of Midodrine Hydrochloride compared with no drug.
1153306|NCT00427895|O3|Outcome|23vPS/23vPS, Cohort 1|Participants 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
1153307|NCT00427895|O2|Outcome|13vPnC/23vPS, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
1153308|NCT00427895|O1|Outcome|13vPnC/13vPnC, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2 [Vax2]) at Year 3 to 4.
1153309|NCT00427895|O4|Outcome|13vPnC, Cohort 3|Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
1153310|NCT00427895|O3|Outcome|13vPnC, Cohort 2|Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
1153311|NCT00427895|O2|Outcome|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
1153312|NCT00427895|O1|Outcome|13vPnC, Cohort 1|Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]).
1153313|NCT00427895|O3|Outcome|23vPs/23vPS, Cohort 1|Participants 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
1153314|NCT00427895|O2|Outcome|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
1153315|NCT00427895|O1|Outcome|13vPnC/23vPS, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
1153316|NCT00427895|O2|Outcome|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
1153317|NCT00427895|O1|Outcome|13vPnC, Cohort 1|Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]).
1153318|NCT00427895|O4|Outcome|13vPnC, Cohort 3|Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
1153319|NCT00427895|O3|Outcome|13vPnC, Cohort 2|Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly at (Vaccination 1).
1153320|NCT00427895|O2|Outcome|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
1153321|NCT00427895|O1|Outcome|13vPnC, Cohort 1|Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]).
1153322|NCT00427895|E16|Reported Event|13vPnC: 6 Month Follow-up After Vax 1, Cohort 3|Participants aged 18-49 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up.
1153323|NCT00427895|E15|Reported Event|13vPnC, Cohort 3|Participants aged 18-49 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported after vaccination 1.
1153324|NCT00427895|E14|Reported Event|13vPnC/13vPnC: 6 Month Follow-up After Vax 2, Cohort 2|Participants aged 50-59 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.
1153325|NCT00427895|E13|Reported Event|13vPnC/13vPnC, Cohort 2|Participants aged 50-59 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported after vaccination 2.
1153326|NCT00427895|E12|Reported Event|23vPS/23vPS: 6 Month Follow-up After Vax 2, Cohort 1|Participants aged 60-64 years old who received 23vPS at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.
1153327|NCT00427895|E11|Reported Event|23vPS/23vPS, Cohort 1|Participants aged 60-64 years old who received 23vPS at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported after vaccination 2.
1153328|NCT00427895|E10|Reported Event|13vPnC/23vPS: 6 Month Follow-up After Vax 2, Cohort 1|Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.
1153329|NCT00427895|E9|Reported Event|13vPnC/23vPS, Cohort 1|Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported after vaccination 2.
1153330|NCT00427895|E8|Reported Event|13vPnC/13vPnC: 6 Month Follow-up After Vax 2, Cohort 1|Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.
1153331|NCT00427895|E7|Reported Event|13vPnC/13vPnC, Cohort 1|Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported after vaccination 2.
1153373|NCT00427661|B1|Baseline|AHSC in Severe SCD|The patient population for this study included severe SCD patients, both pediatric and adult, who did not have end-organ failure, and met all of the eligibility criteria.
1153332|NCT00427895|E6|Reported Event|13vPnC: 6 Month Follow-up After Vax 1, Cohort 2|Participants aged 50-59 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up. Out of 404 participants vaccinated, 1 participant randomized and vaccinated in error without a consent form, and hence safety data is available for 403 participant.
1153333|NCT00427895|E5|Reported Event|13vPnC, Cohort 2|Participants aged 50-59 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported after vaccination 1. Out of 404 participants vaccinated, 1 participant randomized and vaccinated in error without a consent form, and hence safety data is available for 403 participant.
1153334|NCT00427895|E4|Reported Event|23vPS: 6 Month Follow-up After Vax 1, Cohort 1|Participants aged 60-64 years old received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up.
1153335|NCT00427895|E3|Reported Event|23vPS, Cohort 1|Participants aged 60-64 years old received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL (Vaccination 1), reported after vaccination 1.
1153336|NCT00427895|E2|Reported Event|13vPnC: 6 Month Follow-up After Vax 1, Cohort 1|Participants aged 60-64 years old received 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up.
1153337|NCT00427895|E1|Reported Event|13vPnC, Cohort 1|Participants aged 60-64 years old received 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 mL (Vaccination 1 [Vax1]), reported after vaccination.
1153338|NCT00427804|B3|Baseline|Total|Total of all reporting groups
1153339|NCT00427804|B2|Baseline|Crohn's Disease|Subjects with stable Crohn's disease
1153340|NCT00427804|B1|Baseline|Healthy Control|
1153341|NCT00427804|P2|Participant Flow|Crohn's Disease|Subjects with stable Crohn's disease
1153342|NCT00427804|P1|Participant Flow|Healthy Control|
1153343|NCT00427804|O2|Outcome|Crohn's Disease|Subjects with stable Crohn's disease
1153344|NCT00427804|O1|Outcome|Healthy Control|
1153345|NCT00427804|E2|Reported Event|Crohn's Disease|Subjects with stable Crohn's disease
1153346|NCT00427804|E1|Reported Event|Healthy Control|
1153347|NCT00427791|B3|Baseline|Total|Total of all reporting groups
1153348|NCT00427791|B2|Baseline|Etoposide + Total Body Irradiation|Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days
1153349|NCT00427791|B1|Baseline|Etoposide + Total Body Irradiation + Rituximab|Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m^2 IV Weekly Over 4-8 Hours for 4 Weeks
1153350|NCT00427791|P2|Participant Flow|Etoposide + Total Body Irradiation|Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days
1153351|NCT00427791|P1|Participant Flow|Etoposide + Total Body Irradiation + Rituximab|Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m^2 IV Weekly Over 4-8 Hours for 4 Weeks
1153352|NCT00427791|O2|Outcome|Etoposide + Total Body Irradiation|Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days
1153353|NCT00427791|O1|Outcome|Etoposide + Total Body Irradiation + Rituximab|Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m^2 IV Weekly Over 4-8 Hours for 4 Weeks
1153354|NCT00427791|O2|Outcome|Etoposide + Total Body Irradiation|Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days
1153355|NCT00427791|O1|Outcome|Etoposide + Total Body Irradiation + Rituximab|Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m^2 IV Weekly Over 4-8 Hours for 4 Weeks
1153356|NCT00427791|E2|Reported Event|Etoposide + Total Body Irradiation|Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days
1153357|NCT00427791|E1|Reported Event|Etoposide + Total Body Irradiation + Rituximab|Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m^2 IV Weekly Over 4-8 Hours for 4 Weeks
1153358|NCT00427765|B1|Baseline|Busulfan + Melphalan|Busulfan 32 mg/m^2 intravenous (IV) for 1 Day then 130 mg/m^2 IV for 4 Days; and Melphalan 70 mg/m^2 IV for 2 Days
1153359|NCT00427765|P1|Participant Flow|Busulfan + Melphalan|Busulfan 32 mg/m^2 intravenous (IV) for 1 Day then 130 mg/m^2 IV for 4 Days; and Melphalan 70 mg/m^2 IV for 2 Days
1153360|NCT00427765|O1|Outcome|Busulfan + Melphalan|Busulfan 32 mg/m^2 intravenous (IV) for 1 Day then 130 mg/m^2 IV for 4 Days; and Melphalan 70 mg/m^2 IV for 2 Days
1153361|NCT00427765|E1|Reported Event|Busulfan + Melphalan|Busulfan 32 mg/m^2 intravenous (IV) for 1 Day then 130 mg/m^2 IV for 4 Days; and Melphalan 70 mg/m^2 IV for 2 Days
1153362|NCT00427700|B3|Baseline|Total|Total of all reporting groups
1153363|NCT00427700|B2|Baseline|Clomiphene|"Uso of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle~clomiphene citrate: 100mg PO on days 5-9 of the menstrual cycle"
1153364|NCT00427700|B1|Baseline|Raloxifene|"Use of 100mg of raloxifene during days 5-9 of the menstrual cycle~raloxifene: 100mg PO on days 5-9 of the menstrual cycle"
1153365|NCT00427700|P2|Participant Flow|Raloxiphene|Use of 100mg of raloxifene during days 5-9 of the menstrual cycle
1153366|NCT00427700|P1|Participant Flow|Clomiphene|Uso of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle
1153367|NCT00427700|O2|Outcome|Raloxiphene|Use of 100mg of raloxifene during days 5-9 of the menstrual cycle
1153368|NCT00427700|O1|Outcome|Clomiphene|Uso of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle
1153369|NCT00427700|O2|Outcome|Raloxifene|Use of 100mg of raloxifene during days 5-9 of the menstrual cycle
1153370|NCT00427700|O1|Outcome|Clomiphene|Uso of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle
1153371|NCT00427700|E2|Reported Event|Raloxifene|"Use of 100mg of raloxifene during days 5-9 of the menstrual cycle~raloxifene: 100mg PO on days 5-9 of the menstrual cycle~Two cases: one woman had nausea, and the other woman had nausea, headache, and pelvic pain. All mild"
1153372|NCT00427700|E1|Reported Event|Clomiphene Citrate|"Use of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle~clomiphene citrate: 100mg PO on days 5-9 of the menstrual cycle~One woman in the CC group had nausea, headache, and abdominal bloating."
1153632|NCT00426283|P1|Participant Flow|Flovent 1760 mcg|"Drug~Flovent : 1760 mcg daily"
1153374|NCT00427661|P1|Participant Flow|AHSC in Severe SCD|The patient population for this study included severe SCD patients, both pediatric and adult, who did not have end-organ failure, and met all of the eligibility criteria.
1153375|NCT00427661|O1|Outcome|Experimental|Busulfan, Fludarabine, Cyclosporine, MMF
1153376|NCT00427661|O1|Outcome|AHSC in Severe SCD|The patient population for this study included severe SCD patients, both pediatric and adult, who did not have end-organ failure, and met all of the eligibility criteria.
1153377|NCT00427661|O1|Outcome|AHSC in Severe SCD|The patient population for this study included severe SCD patients, both pediatric and adult, who did not have end-organ failure, and met all of the eligibility criteria.
1153378|NCT00427661|E1|Reported Event|AHSC in Severe SCD|The patient population for this study included severe SCD patients, both pediatric and adult, who did not have end-organ failure, and met all of the eligibility criteria.
1153379|NCT00427635|B3|Baseline|Total|Total of all reporting groups
1153380|NCT00427635|B2|Baseline|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
1153381|NCT00427635|B1|Baseline|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
1153382|NCT00427635|P2|Participant Flow|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
1153383|NCT00427635|P1|Participant Flow|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
1153384|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
1153385|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
1153386|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
1153387|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
1153388|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
1153389|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
1153390|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
1153391|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
1153392|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
1153393|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
1153394|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
1153395|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
1153396|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
1153397|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
1153398|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
1153399|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
1153400|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
1153401|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
1153402|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
1153403|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
1153404|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
1153405|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
1153406|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
1153407|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
1153408|NCT00427635|E2|Reported Event|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
1153409|NCT00427635|E1|Reported Event|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
1153633|NCT00426283|O2|Outcome|Placebo 1760 mcg|Placebo : 1760 mcg daily
1153410|NCT00427557|B1|Baseline|Cellular Therapy With Cord Blood Cells|Fludarabine 30 mg/m^2 intravenous (IV) for 4 Days + Melphalan 140 mg/m^2 IV for 1 Day + Rituximab 375 mg/m^2 IV once weekly + Cord Blood Transplantation + Stem Cell Transplantation Infusion
1153411|NCT00427557|P1|Participant Flow|Cellular Therapy With Cord Blood Cells|Fludarabine 30 mg/m^2 intravenous (IV) for 4 Days + Melphalan 140 mg/m^2 IV for 1 Day + Rituximab 375 mg/m^2 IV once weekly + Cord Blood Transplantation + Stem Cell Transplantation Infusion
1153412|NCT00427557|O1|Outcome|Fludarabine + Melphalan + Umbilical Cord Blood Unit|Fludarabine 30 mg/m^2 given daily for four days. Melphalan 140 mg/m^2 given for one day. Umbilical Cord Blood Unit given on one day.
1153413|NCT00427557|E1|Reported Event|Cellular Therapy With Cord Blood Cells|Fludarabine 30 mg/m^2 intravenous (IV) for 4 Days + Melphalan 140 mg/m^2 IV for 1 Day + Rituximab 375 mg/m^2 IV once weekly + Cord Blood Transplantation + Stem Cell Transplantation Infusion
1153499|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
1153414|NCT00427349|B1|Baseline|AMG 706+Octreotide|"Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~AMG 706: AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment.~octreotide: One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles."
1153415|NCT00427349|P1|Participant Flow|AMG 706+Octreotide|"Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~AMG 706: AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment.~octreotide: One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles."
1153416|NCT00427349|O1|Outcome|AMG 706+Octreotide|"Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~AMG 706: AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment.~octreotide: One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles."
1153417|NCT00427349|O1|Outcome|AMG 706+Octreotide|"Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~AMG 706: AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment.~octreotide: One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles."
1153418|NCT00427349|O1|Outcome|AMG 706+Octreotide|"Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~AMG 706: AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment.~octreotide: One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles."
1153419|NCT00427349|E1|Reported Event|MG 706+Octreotide|AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment. Each cycle was defined as 28 days. AMG 706 was started within 7 working days of registration, given on the same day as the octreotide-LAR.
1153420|NCT00427336|B1|Baseline|Fludarabine + Cyclophosphamide + ATG|Fludarabine 30 mg/m^2/day by vein (IV), Cyclophosphamide IV 300 mg/m^2/day, ATG (Antithymocyte Globulin) IV 3.75 mg/kg/day
1153421|NCT00427336|P1|Participant Flow|Fludarabine + Cyclophosphamide + ATG|Fludarabine 30 mg/m^2/day by vein (IV), Cyclophosphamide IV 300 mg/m^2/day, ATG (Antithymocyte Globulin) IV 3.75 mg/kg/day
1153422|NCT00427336|O1|Outcome|Fludarabine + Cyclophosphamide + ATG|Fludarabine 30 mg/m^2/day by vein (IV), Cyclophosphamide IV 300 mg/m^2/day, ATG (Antithymocyte Globulin) IV 3.75 mg/kg/day
1153423|NCT00427336|E1|Reported Event|Fludarabine + Cyclophosphamide + ATG|Fludarabine 30 mg/m^2/day by vein (IV), Cyclophosphamide IV 300 mg/m^2/day, ATG (Antithymocyte Globulin) IV 3.75 mg/kg/day
1153424|NCT00427037|B3|Baseline|Total|Total of all reporting groups
1153425|NCT00427037|B2|Baseline|Cholecalciferol|This is vitamin D3 or Cholecalciferol
1153426|NCT00427037|B1|Baseline|Placebo|This is a matching placebo
1153427|NCT00427037|P2|Participant Flow|Cholecalciferol|This is vitamin D3 or Cholecalciferol
1153428|NCT00427037|P1|Participant Flow|Placebo|This is a matching placebo
1153429|NCT00427037|O2|Outcome|Cholecalciferol|This is vitamin D3 or Cholecalciferol
1153430|NCT00427037|O1|Outcome|Placebo|This is a matching placebo
1153431|NCT00427037|O2|Outcome|Cholecalciferol|"D3~Cholecalciferol: 50,000 IU weekly by mouth"
1153432|NCT00427037|O1|Outcome|Placebo|"Placebo~Placebo: identical placebo pill orally by mouth"
1153433|NCT00427037|E2|Reported Event|Cholecalciferol|This is vitamin D3 or Cholecalciferol
1153434|NCT00427037|E1|Reported Event|Placebo|This is a matching placebo
1153492|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
1153435|NCT00427011|B1|Baseline|Perampanel|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
1153436|NCT00427011|P1|Participant Flow|Perampanel|Subjects entered this open-label extension study from the double-blind core study E2007-A001-214 (NCT00165789), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
1153559|NCT00426556|O2|Outcome|Phase I - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
1153437|NCT00427011|O2|Outcome|Perampanel (Perampanel During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
1153438|NCT00427011|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
1153439|NCT00427011|O2|Outcome|Perampanel (Perampanel During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
1153440|NCT00427011|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
1153441|NCT00427011|O2|Outcome|Perampanel (Perampanel During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
1153442|NCT00427011|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
1153443|NCT00427011|O2|Outcome|Perampanel (Perampanel During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
1153444|NCT00427011|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
1153493|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
1153445|NCT00427011|E1|Reported Event|Perampanel|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
1153446|NCT00426855|B1|Baseline|Group 1|Bortezomib, Bendamustin, combination chemotherapy in nhl
1153447|NCT00426855|P1|Participant Flow|Group 1|Bortezomib, Bendamustine, NHL, combination chemotherapy
1153448|NCT00426855|O1|Outcome|Group 1|NHL treated with combination chemotherapy of bendamustin and bortezomib
1153449|NCT00426855|E1|Reported Event|Group 1|NHL Patients treated with combination of bendamustine and bortezomib
1153450|NCT00426842|B1|Baseline|Arm 1|Blood pressure response during HUT following administration of Midodrine Hydrochloride compared with no drug.
1153451|NCT00426842|P1|Participant Flow|All Participants|All participants underwent a head-up tilt maneuver following no-drug, midodrine 5 mg and midodrine 10 mg, in that order, on seperate study visits. Blood pressure response during HUT following administration of Midodrine Hydrochloride compared with no drug.
1153452|NCT00426842|O3|Outcome|Midodrine 10 mg|
1153453|NCT00426842|O2|Outcome|Midodrine 5 mg|
1153456|NCT00426764|B1|Baseline|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
1153457|NCT00426764|P1|Participant Flow|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
1153458|NCT00426764|O6|Outcome|Best ECOG = 4|Participants with a best on study ECOG performance score of 4, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
1153459|NCT00426764|O5|Outcome|Best ECOG = 3|Participants with a best on study ECOG performance score of 3, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
1153460|NCT00426764|O4|Outcome|Best ECOG = 2|Participants with a best on study ECOG performance score of 2, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
1153461|NCT00426764|O3|Outcome|Best ECOG = 1|Participants with a best on study ECOG performance score of 1, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
1153462|NCT00426764|O2|Outcome|Best ECOG = 0|Participants with a best on study ECOG performance score of 0, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
1153463|NCT00426764|O1|Outcome|Missing|Participants with a missing best on study ECOG performance score, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
1153464|NCT00426764|O1|Outcome|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
1153465|NCT00426764|O1|Outcome|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
1153466|NCT00426764|O1|Outcome|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
1153467|NCT00426764|O1|Outcome|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
1153468|NCT00426764|O1|Outcome|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
1153469|NCT00426764|E1|Reported Event|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
1153470|NCT00426751|B3|Baseline|Total|Total of all reporting groups
1153471|NCT00426751|B2|Baseline|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
1163353|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
1153472|NCT00426751|B1|Baseline|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
1153473|NCT00426751|P2|Participant Flow|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
1153474|NCT00426751|P1|Participant Flow|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
1153475|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
1153476|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
1153477|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
1153478|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
1153479|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
1153480|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
1153481|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
1153482|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
1153483|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
1153484|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
1153485|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
1153486|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
1153487|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
1153488|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
1153489|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
1153490|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
1153491|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
1153550|NCT00426556|P3|Participant Flow|Phase I - RAD001 30mg + PT, Weekly|Weekly dosing schedule of Everolimus 30mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab.
1153494|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
1153495|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
1153496|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
1153497|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
1153498|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
1153500|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
1153501|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
1153502|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
1153503|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
1153504|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
1153505|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
1153506|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
1153507|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
1153508|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
1153509|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
1153510|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
1153511|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
1153512|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
1153513|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
1153514|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
1153515|NCT00426751|E2|Reported Event|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
1153516|NCT00426751|E1|Reported Event|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
1153517|NCT00426660|B1|Baseline|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
1153518|NCT00426660|P1|Participant Flow|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
1153519|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
1153520|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
1153551|NCT00426556|P2|Participant Flow|Phase I - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
1153521|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
1153522|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
1153523|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
1153524|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
1153525|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
1153526|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
1153527|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
1153528|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
1153529|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
1153530|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
1153531|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
1153532|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
1153533|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
1153534|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
1153535|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
1153536|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
1153537|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
1153538|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
1153539|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
1153540|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
1153541|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
1153542|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
1153543|NCT00426660|E1|Reported Event|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
1153544|NCT00426556|B5|Baseline|Total|Total of all reporting groups
1153545|NCT00426556|B4|Baseline|Phase II - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
1153546|NCT00426556|B3|Baseline|Phase I - RAD001 30mg + PT, Weekly|Weekly dosing schedule of Everolimus 30mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab.
1153547|NCT00426556|B2|Baseline|Phase I - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
1153548|NCT00426556|B1|Baseline|Phase I - RAD001 5mg + PT, Daily|Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
1153549|NCT00426556|P4|Participant Flow|Phase II - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
1153634|NCT00426283|O1|Outcome|Flovent 1760 mcg|"Drug~Flovent : 1760 mcg daily"
1153552|NCT00426556|P1|Participant Flow|Phase I - RAD001 5mg + PT, Daily|Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
1153553|NCT00426556|O4|Outcome|Phase II - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
1153554|NCT00426556|O3|Outcome|Phase I - RAD001 30mg + PT, Weekly|Weekly dosing schedule of Everolimus 30mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab.
1153555|NCT00426556|O2|Outcome|Phase I - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
1153556|NCT00426556|O1|Outcome|Phase I - RAD001 5mg + PT, Daily|Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
1153557|NCT00426556|O4|Outcome|Phase II - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
1153558|NCT00426556|O3|Outcome|Phase I - RAD001 30mg + PT, Weekly|Weekly dosing schedule of Everolimus 30mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab.
1153989|NCT00425373|O7|Outcome|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
1153560|NCT00426556|O1|Outcome|Phase I - RAD001 5mg + PT, Daily|Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
1153561|NCT00426556|O4|Outcome|Phase II - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
1153562|NCT00426556|O3|Outcome|Phase I - RAD001 30mg + PT, Weekly|Weekly dosing schedule of Everolimus 30mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab.
1153563|NCT00426556|O2|Outcome|Phase I - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
1153564|NCT00426556|O1|Outcome|Phase I - RAD001 5mg + PT, Daily|Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
1153565|NCT00426556|O4|Outcome|Phase II - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
1153566|NCT00426556|O3|Outcome|Phase I - RAD001 30mg + PT, Weekly|Weekly dosing schedule of Everolimus 30mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab.
1153567|NCT00426556|O2|Outcome|Phase I - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
1153568|NCT00426556|O1|Outcome|Phase I - RAD001 5mg + PT, Daily|Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
1153569|NCT00426556|E4|Reported Event|Phase II - Everolimus 10mg Daily + PT|Phase II - Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
1153570|NCT00426556|E3|Reported Event|Phase I - Everolimus 30mg Weekly + PT|Phase I - Weekly dosing schedule of Everolimus 30mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
1153571|NCT00426556|E2|Reported Event|Phase I - Everolimus 10mg Daily + PT|Phase I - Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
1153572|NCT00426556|E1|Reported Event|Phase I - Everolimus 5mg Daily + PT|Phase I - Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
1153573|NCT00426361|B4|Baseline|Total|Total of all reporting groups
1153574|NCT00426361|B3|Baseline|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
1153575|NCT00426361|B2|Baseline|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
1153576|NCT00426361|B1|Baseline|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
1153577|NCT00426361|P3|Participant Flow|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
1153578|NCT00426361|P2|Participant Flow|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
1153579|NCT00426361|P1|Participant Flow|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
1153580|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
1153581|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
1153582|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
1153583|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
1153584|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
1153585|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
1153586|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
1153587|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
1153588|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
1153589|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
1153590|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
1153635|NCT00426283|E2|Reported Event|Placebo 1760 mcg|Placebo : 1760 mcg daily
1153592|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
1153593|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
1153594|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
1153595|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
1153596|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
1153597|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
1153598|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
1153599|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
1153600|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
1153601|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
1153602|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
1153603|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
1153604|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
1153605|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
1153606|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
1153607|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
1153608|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
1153609|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
1153610|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
1153611|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
1153612|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
1153613|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
1153614|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
1153615|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
1153616|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
1153617|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
1153618|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
1153619|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
1153620|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
1153621|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
1153622|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
1153623|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
1153624|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
1153625|NCT00426361|E3|Reported Event|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
1153626|NCT00426361|E2|Reported Event|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
1153627|NCT00426361|E1|Reported Event|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
1153628|NCT00426283|B3|Baseline|Total|Total of all reporting groups
1153629|NCT00426283|B2|Baseline|Placebo 1760 mcg|Placebo : 1760 mcg daily
1153630|NCT00426283|B1|Baseline|Flovent 1760 mcg|"Drug~Flovent : 1760 mcg daily"
1153631|NCT00426283|P2|Participant Flow|Placebo 1760 mcg|Placebo : 1760 mcg daily
1153637|NCT00426270|B1|Baseline|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
1153638|NCT00426270|P1|Participant Flow|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
1153639|NCT00426270|O1|Outcome|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
1153640|NCT00426270|O1|Outcome|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
1153641|NCT00426270|O1|Outcome|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
1153642|NCT00426270|O1|Outcome|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
1153643|NCT00426270|O1|Outcome|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
1153644|NCT00426270|E1|Reported Event|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
1153645|NCT00426231|B3|Baseline|Total|Total of all reporting groups
1153646|NCT00426231|B2|Baseline|Information Control|"Information control~Information control : Information about medication access programs provided to the participant and their healthcare provider"
1153647|NCT00426231|B1|Baseline|Patient Navigator Intervention|"Patient Navigator intervention~Navigation by a health worker : Help provided by health worker to navigate medication access programs"
1153648|NCT00426231|P2|Participant Flow|Information Control|"Information control~Information control : Information about medication access programs provided to the participant and their healthcare provider"
1153649|NCT00426231|P1|Participant Flow|Patient Navigator Intervention|"Patient Navigator intervention~Navigation by a health worker : Help provided by health worker to navigate medication access programs"
1153650|NCT00426231|O2|Outcome|Information Control|"Information control~Information control : Information about medication access programs provided to the participant and their healthcare provider"
1153651|NCT00426231|O1|Outcome|Patient Navigator Intervention|"Patient Navigator intervention~Navigation by a health worker : Help provided by health worker to navigate medication access programs"
1153652|NCT00426231|O2|Outcome|Information Control|"Information control~Information control : Information about medication access programs provided to the participant and their healthcare provider"
1153653|NCT00426231|O1|Outcome|Patient Navigator Intervention|"Patient Navigator intervention~Navigation by a health worker : Help provided by health worker to navigate medication access programs"
1153654|NCT00426231|E2|Reported Event|Information Control|"Information control~Information control : Information about medication access programs provided to the participant and their healthcare provider"
1153655|NCT00426231|E1|Reported Event|Patient Navigator Intervention|"Patient Navigator intervention~Navigation by a health worker : Help provided by health worker to navigate medication access programs"
1153656|NCT00426153|B3|Baseline|Total|Total of all reporting groups
1153657|NCT00426153|B2|Baseline|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
1153658|NCT00426153|B1|Baseline|Octreotide|Participants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year
1153659|NCT00426153|P2|Participant Flow|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
1153660|NCT00426153|P1|Participant Flow|Octreotide|Participants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year
1153661|NCT00426153|O2|Outcome|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
1153662|NCT00426153|O1|Outcome|Octreotide|Participants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year
1153663|NCT00426153|O2|Outcome|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
1153664|NCT00426153|O1|Outcome|Octreotide|Participants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year
1153665|NCT00426153|O2|Outcome|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
1153666|NCT00426153|O1|Outcome|Octreotide|Participants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year
1153667|NCT00426153|O2|Outcome|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
1153668|NCT00426153|O1|Outcome|Octreotide|Participants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year
1153669|NCT00426153|E2|Reported Event|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
1153670|NCT00426153|E1|Reported Event|Octreotide|Participants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year
1153671|NCT00426127|B1|Baseline|Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin|"Docetaxel 75 mg/m^2 + Doxil 30 mg/m^2 + Enoxaparin 1.5 mg/kg~Docetaxel~Liposomal Doxorubicin~Enoxaparin"
1153672|NCT00426127|P1|Participant Flow|Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin|"Docetaxel 75 mg/m^2 + Doxil 30 mg/m^2 + Enoxaparin 1.5 mg/kg~Docetaxel~Liposomal Doxorubicin~Enoxaparin"
1153673|NCT00426127|O1|Outcome|Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin|"Docetaxel 75 mg/m^2 + Doxil 30 mg/m^2 + Enoxaparin 1.5 mg/kg~Docetaxel~Liposomal Doxorubicin~Enoxaparin"
1153674|NCT00426127|O1|Outcome|Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin|"Docetaxel 75 mg/m^2 + Doxil 30 mg/m^2 + Enoxaparin 1.5 mg/kg~Docetaxel~Liposomal Doxorubicin~Enoxaparin"
1153675|NCT00426127|O1|Outcome|Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin|"Docetaxel 75 mg/m^2 + Doxil 30 mg/m^2 + Enoxaparin 1.5 mg/kg~Docetaxel~Liposomal Doxorubicin~Enoxaparin"
1153676|NCT00426127|E1|Reported Event|Docetaxel and Liposomal Doxorubicin Combined With Enoxaparin|"Docetaxel 75 mg/m^2 + Doxil 30 mg/m^2 + Enoxaparin 1.5 mg/kg~Docetaxel~Liposomal Doxorubicin~Enoxaparin"
1153677|NCT00425113|B3|Baseline|Total|Total of all reporting groups
1153678|NCT00425113|B2|Baseline|Placebo|
1153679|NCT00425113|B1|Baseline|Metronidazole|Subjects were randomized to receive metronidazole 500 mg TID or placebo for 8 weeks, in addition to an individualized background TB treatment regimen. Total duration of treatment was about 18 months following sputum culture conversion.
1153680|NCT00425113|P2|Participant Flow|Placebo|
1153681|NCT00425113|P1|Participant Flow|Metronidazole|Subjects were randomized to receive metronidazole 500 mg TID or placebo for 8 weeks, in addition to an individualized background TB treatment regimen. Total duration of treatment was about 18 months following sputum culture conversion.
1153682|NCT00425113|O2|Outcome|Placebo|
1153746|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153683|NCT00425113|O1|Outcome|Metronidazole|Subjects were randomized to receive metronidazole 500 mg TID or placebo for 8 weeks, in addition to an individualized background TB treatment regimen. Total duration of treatment was about 18 months following sputum culture conversion.
1153684|NCT00425113|O2|Outcome|Placebo|
1153685|NCT00425113|O1|Outcome|Metronidazole|Subjects were randomized to receive metronidazole 500 mg three times daily or placebo for 8 weeks, in addition to an individualized background TB treatment regimen. Total duration of treatment was about 18 months following sputum culture conversion.
1153686|NCT00425113|E2|Reported Event|Placebo|
1153687|NCT00425113|E1|Reported Event|Metronidazole|Subjects were randomized to receive metronidazole 500 mg TID or placebo for 8 weeks, in addition to an individualized background TB treatment regimen. Total duration of treatment was about 18 months following sputum culture conversion.
1153688|NCT00425100|B1|Baseline|Open Label-fesoterodine|All enrolled subjects were treated with fesoterodine 4 mg once daily (QD) for 4 weeks followed by either 4 mg QD or 8 mg QD for the remaining 8 weeks of the study.
1153689|NCT00425100|P1|Participant Flow|Open Label-fesoterodine|All enrolled subjects were treated with fesoterodine 4 mg once daily (QD) for 4 weeks followed by either 4 mg QD or 8 mg QD for the remaining 8 weeks of the study.
1153690|NCT00425100|O1|Outcome|Open Label Week 12|
1153691|NCT00425100|O2|Outcome|Open Label Week 12|
1153692|NCT00425100|O1|Outcome|Open Label Baseline|
1153693|NCT00425100|O1|Outcome|Open Label Week 12|
1153694|NCT00425100|O2|Outcome|Open Label Week 12|
1153695|NCT00425100|O1|Outcome|Open Label Baseline|
1153696|NCT00425100|O2|Outcome|Open Label Week 12|
1153697|NCT00425100|O1|Outcome|Open Label Baseline|
1153698|NCT00425100|O2|Outcome|Open Label Week 12|
1153699|NCT00425100|O1|Outcome|Open Label Baseline|
1153700|NCT00425100|O2|Outcome|Open Label Week 12|
1153701|NCT00425100|O1|Outcome|Open Label Baseline|
1153702|NCT00425100|O2|Outcome|Open Label Week 12|
1153703|NCT00425100|O1|Outcome|Open Label Baseline|
1153704|NCT00425100|O2|Outcome|Open Label Week 12|
1153705|NCT00425100|O1|Outcome|Open Label Baseline|
1153706|NCT00425100|O1|Outcome|Open Label Week 12|
1153707|NCT00425100|O2|Outcome|Open Label Week 12|
1153708|NCT00425100|O1|Outcome|Open Label Baseline|
1153709|NCT00425100|O1|Outcome|Open Label Week 12|
1153710|NCT00425100|O2|Outcome|Open Label Week 12|
1153711|NCT00425100|O1|Outcome|Open Label Baseline|
1153712|NCT00425100|O2|Outcome|Open Label Week 12|
1153713|NCT00425100|O1|Outcome|Open Label Baseline|
1153714|NCT00425100|O2|Outcome|Open Label Week 12|
1153715|NCT00425100|O1|Outcome|Open Label Baseline|
1153716|NCT00425100|O2|Outcome|Open Label Week 12|
1153717|NCT00425100|O1|Outcome|Open Label Baseline|
1153718|NCT00425100|O1|Outcome|Open Label Week 12|
1153719|NCT00425100|O2|Outcome|Open Label Week 12|
1153720|NCT00425100|O1|Outcome|Open Label Baseline|
1153721|NCT00425100|O2|Outcome|Open Label Week 12|
1153722|NCT00425100|O1|Outcome|Open Label Baseline|
1153723|NCT00425100|O2|Outcome|Open Label Week 12|
1153724|NCT00425100|O1|Outcome|Open Label Baseline|
1153725|NCT00425061|B8|Baseline|Total|Total of all reporting groups
1153726|NCT00425061|B7|Baseline|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153727|NCT00425061|B6|Baseline|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
1153728|NCT00425061|B5|Baseline|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153729|NCT00425061|B4|Baseline|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153730|NCT00425061|B3|Baseline|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153731|NCT00425061|B2|Baseline|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153732|NCT00425061|B1|Baseline|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153733|NCT00425061|P7|Participant Flow|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153734|NCT00425061|P6|Participant Flow|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
1153735|NCT00425061|P5|Participant Flow|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153736|NCT00425061|P4|Participant Flow|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153737|NCT00425061|P3|Participant Flow|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153738|NCT00425061|P2|Participant Flow|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153739|NCT00425061|P1|Participant Flow|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153740|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153741|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
1153742|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153743|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153744|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153745|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153837|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153747|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153748|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
1153749|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153750|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153751|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153752|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153753|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153754|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153755|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
1153756|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153757|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153758|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153759|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153760|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153761|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153762|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
1153763|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153764|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153765|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153766|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153767|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153768|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153769|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
1153770|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153771|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153772|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153773|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153774|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153775|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153776|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
1153777|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153778|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153779|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153780|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153781|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153782|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153783|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
1153784|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153785|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1155686|NCT00422695|B1|Baseline|HIV +|Groups divided according to CD4 counts
1153786|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153787|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153788|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153789|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153790|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
1153791|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1163354|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1153792|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153793|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153794|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153795|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153796|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153797|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
1153798|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153799|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153800|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153801|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153802|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153803|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153804|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
1153805|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153806|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153807|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153808|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153809|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153810|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153811|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
1153812|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153813|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153814|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153815|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153816|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153817|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153818|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
1153819|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153820|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153821|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153822|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153823|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153824|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153825|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
1153826|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153827|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153828|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153829|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153830|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153831|NCT00425061|O2|Outcome|Placebo|Included all participants who received placebo matched to IMA-638 subcutaneous injection during Stage 1, 2 or 3.
1153832|NCT00425061|O1|Outcome|IMA-638|Included participants who received any dose of IMA-638 subcutaneous injection during Stage 1, 2 or 3.
1153833|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153834|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
1153835|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153836|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1156287|NCT00421993|O3|Outcome|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
1153838|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153839|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153840|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153841|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
1153842|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153843|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153844|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153845|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153846|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153847|NCT00425061|E7|Reported Event|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153848|NCT00425061|E6|Reported Event|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
1153849|NCT00425061|E5|Reported Event|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
1153850|NCT00425061|E4|Reported Event|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153851|NCT00425061|E3|Reported Event|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153852|NCT00425061|E2|Reported Event|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153853|NCT00425061|E1|Reported Event|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
1153854|NCT00425945|B3|Baseline|Total|Total of all reporting groups
1153855|NCT00425945|B2|Baseline|Placebo|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
1153856|NCT00425945|B1|Baseline|Pine Bark Extract|200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily. Pine Bark Extract (Flavangenol�) : Flavangenol 200 mg per day. Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks.
1153857|NCT00425945|P2|Participant Flow|Placebo|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
1153858|NCT00425945|P1|Participant Flow|Pine Bark Extract|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
1153859|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
1153860|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
1153861|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
1153862|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
1153863|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
1153864|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
1153865|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
1153887|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
1153866|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
1153867|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
1153868|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
1156288|NCT00421993|O2|Outcome|Adapalene Gel|Adapalene Topical Gel
1153869|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
1153870|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
1153871|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
1153872|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
1153873|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
1153874|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
1153875|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
1153876|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
1153877|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
1153878|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
1153879|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
1153880|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
1153881|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
1153882|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
1153883|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
1153884|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
1153885|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
1153886|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
1153968|NCT00425373|B10|Baseline|Total|Total of all reporting groups
1153888|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
1153889|NCT00425945|O2|Outcome|Placebo|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
1153890|NCT00425945|O1|Outcome|Pine Bark Extract|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
1163355|NCT00402987|O3|Outcome|Placebo|
1153891|NCT00425945|E2|Reported Event|Placebo|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
1153892|NCT00425945|E1|Reported Event|Pine Bark Extract|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
1153893|NCT00425854|B3|Baseline|Total|Total of all reporting groups
1153894|NCT00425854|B2|Baseline|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
1153895|NCT00425854|B1|Baseline|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
1153896|NCT00425854|P2|Participant Flow|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
1153897|NCT00425854|P1|Participant Flow|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
1153898|NCT00425854|O2|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
1153899|NCT00425854|O1|Outcome|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
1153900|NCT00425854|O2|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
1153901|NCT00425854|O1|Outcome|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
1153902|NCT00425854|O2|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
1153903|NCT00425854|O1|Outcome|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
1153904|NCT00425854|O2|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
1153905|NCT00425854|O1|Outcome|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
1153906|NCT00425854|O1|Outcome|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
1153907|NCT00425854|O1|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
1153908|NCT00425854|O2|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
1153909|NCT00425854|O1|Outcome|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
1153910|NCT00425854|O2|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
1153911|NCT00425854|O1|Outcome|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
1153912|NCT00425854|O2|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
1153913|NCT00425854|O1|Outcome|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
1153914|NCT00425854|O1|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
1153915|NCT00425854|E2|Reported Event|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
1153916|NCT00425854|E1|Reported Event|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
1153917|NCT00425750|B1|Baseline|Bortezomib; Docetaxel|Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
1153969|NCT00425373|B9|Baseline|Placebo|4 tablet and 2 capsule placebos taken once daily
1153918|NCT00425750|P1|Participant Flow|Bortezomib; Docetaxel|Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
1153919|NCT00425750|O1|Outcome|Bortezomib; Docetaxel|Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
1153920|NCT00425750|O1|Outcome|Bortezomib; Docetaxel|Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
1153983|NCT00425373|P4|Participant Flow|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1153984|NCT00425373|P3|Participant Flow|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1153921|NCT00425750|O1|Outcome|Bortezomib; Docetaxel|Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
1153922|NCT00425750|E1|Reported Event|Bortezomib; Docetaxel|Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
1153923|NCT00425698|B3|Baseline|Total|Total of all reporting groups
1153924|NCT00425698|B2|Baseline|Placebo|
1153925|NCT00425698|B1|Baseline|Erythropoietin|
1153926|NCT00425698|P2|Participant Flow|Placebo|
1153927|NCT00425698|P1|Participant Flow|Erythropoietin|
1153928|NCT00425698|O2|Outcome|Placebo|
1153929|NCT00425698|O1|Outcome|Erythropoietin|
1153930|NCT00425698|E2|Reported Event|Placebo|
1153931|NCT00425698|E1|Reported Event|Erythropoietin|
1153932|NCT00425607|B1|Baseline|Lonafarnib|Lonafarnib (Merck & Co., Inc.) dosing was initiated at 115 mg/m2 and was increased to 150 mg/m2 after an adjustment period of at least 4 mo. Dosage was reduced back to 115 mg/m2 fo patients experiencing drug-related grade 3 or 4 toxicity and also not responding to supportive care. Once dosage was reduced, patients were permitted to increase the dose of lonafarnib. Patients received oral lonafarnib either by capsule or liquid suspension dispersed in Ora-Blend SF or Ora-Plus (Paddock Laboratories, Inc.) every 12 ± 2 h for a period of 24–29 mo.
1153933|NCT00425607|P1|Participant Flow|Lonafarnib|Lonafarnib (Merck & Co., Inc.) dosing was initiated at 115 mg/m2 and was increased to 150 mg/m2 after an adjustment period of at least 4 mo. Dosage was reduced back to 115 mg/m2 for patients experiencing drug-related grade 3 or 4 toxicity and also not responding to supportive care. Once dosage was reduced, patients were permitted to increase the dose of lonafarnib. Patients received oral lonafarnib either by capsule or liquid suspension dispersed in Ora-Blend SF or Ora-Plus (Paddock Laboratories, Inc.) every 12 ± 2 h for a period of 24–29 mo.
1153934|NCT00425607|O1|Outcome|Lonafarnib|Lonafarnib (Merck & Co., Inc.) dosing was initiated at 115 mg/m2 and was increased to 150 mg/m2 after an adjustment period of at least 4 mo. Dosage was reduced back to 115 mg/m2 for patients experiencing drug-related grade 3 or 4 toxicity and also not responding to supportive care. Once dosage was reduced, patients were permitted to increase the dose of lonafarnib. Patients received oral lonafarnib either by capsule or liquid suspension dispersed in Ora-Blend SF or Ora-Plus (Paddock Laboratories, Inc.) every 12 ± 2 h for a period of 24–29 mo.
1153935|NCT00425607|E1|Reported Event|Lonafarnib|Lonafarnib (Merck & Co., Inc.) dosing was initiated at 115 mg/m2 and was increased to 150 mg/m2 after an adjustment period of at least 4 mo. Dosage was reduced back to 115 mg/m2 fo patients experiencing drug-related grade 3 or 4 toxicity and also not responding to supportive care. Once dosage was reduced, patients were permitted to increase the dose of lonafarnib. Patients received oral lonafarnib either by capsule or liquid suspension dispersed in Ora-Blend SF or Ora-Plus (Paddock Laboratories, Inc.) every 12 ± 2 h for a period of 24–29 mo. Patients were monitored for liver, kidney, and hematological toxicity each month for the first 3 mo by their local physicians and every 4 mo in Boston for the duration of the study. Adverse events were monitored and recorded throughout the study.
1153936|NCT00425503|B1|Baseline|PS-341|Patients will receive one (1) four (4) week cycle of weekly IV PS-341 followed by a standard of care radical prostatectomy 24 to 72 hours later.
1153937|NCT00425503|P1|Participant Flow|PS-341|Patients will receive one (1) four (4) week cycle of weekly IV PS-341 followed by a standard of care radical prostatectomy 24 to 72 hours later.
1153938|NCT00425503|O1|Outcome|PS-341|Patients will receive one (1) four (4) week cycle of weekly IV PS-341 followed by a standard of care radical prostatectomy 24 to 72 hours later.
1153939|NCT00425503|E1|Reported Event|PS-341|Patients will receive one (1) four (4) week cycle of weekly IV PS-341 followed by a standard of care radical prostatectomy 24 to 72 hours later.
1153940|NCT00425438|B3|Baseline|Total|Total of all reporting groups
1153941|NCT00425438|B2|Baseline|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
1153970|NCT00425373|B8|Baseline|Amlodipine 5 mg|Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
1153971|NCT00425373|B7|Baseline|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
1153972|NCT00425373|B6|Baseline|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1156442|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
1153942|NCT00425438|B1|Baseline|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
1153943|NCT00425438|P2|Participant Flow|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 grams per square meter (g/m^2), intravenously (IV), every 4 weeks from Weeks 1 through 4, and 0.5 to (-) 1.0 g/m^2, IV, to maintain a minimum white blood cell (WBC) count of greater than or equal to (≥) 2500 per cubic millimeter (/mm^3) every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
1153985|NCT00425373|P2|Participant Flow|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1153986|NCT00425373|P1|Participant Flow|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1153987|NCT00425373|O9|Outcome|Placebo|4 tablet and 2 capsule placebos taken once daily
1153944|NCT00425438|P1|Participant Flow|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
1153945|NCT00425438|O2|Outcome|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
1153946|NCT00425438|O1|Outcome|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
1153947|NCT00425438|O2|Outcome|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
1153948|NCT00425438|O1|Outcome|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
1153949|NCT00425438|O2|Outcome|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
1153950|NCT00425438|O1|Outcome|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
1153951|NCT00425438|O2|Outcome|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
1153973|NCT00425373|B5|Baseline|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1156443|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
1153952|NCT00425438|O1|Outcome|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
1153953|NCT00425438|O2|Outcome|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
1153954|NCT00425438|O1|Outcome|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
1153988|NCT00425373|O8|Outcome|Amlodipine 5 mg|Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
1163356|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
1153955|NCT00425438|O2|Outcome|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
1153956|NCT00425438|O1|Outcome|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
1153957|NCT00425438|E2|Reported Event|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
1153958|NCT00425438|E1|Reported Event|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
1153959|NCT00425386|B1|Baseline|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;~100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;~150 mg/day, continuous daily~Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
1153960|NCT00425386|P1|Participant Flow|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;~100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;~150 mg/day, continuous daily~Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
1153961|NCT00425386|O1|Outcome|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;~100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;~150 mg/day, continuous daily~Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
1153962|NCT00425386|O1|Outcome|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;~100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;~150 mg/day, continuous daily~Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
1153963|NCT00425386|O1|Outcome|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;~100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;~150 mg/day, continuous daily~Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
1153964|NCT00425386|O1|Outcome|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;~100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;~150 mg/day, continuous daily~Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
1153965|NCT00425386|O1|Outcome|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;~100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;~150 mg/day, continuous daily~Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
1153966|NCT00425386|O1|Outcome|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;~100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;~150 mg/day, continuous daily~Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
1153967|NCT00425386|E1|Reported Event|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;~100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;~150 mg/day, continuous daily~Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
1153974|NCT00425373|B4|Baseline|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1153975|NCT00425373|B3|Baseline|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1153976|NCT00425373|B2|Baseline|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1153977|NCT00425373|B1|Baseline|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1153978|NCT00425373|P9|Participant Flow|Placebo|4 tablet and 2 capsule placebos taken once daily
1153979|NCT00425373|P8|Participant Flow|Amlodipine 5 mg|Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
1153980|NCT00425373|P7|Participant Flow|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
1153981|NCT00425373|P6|Participant Flow|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1153982|NCT00425373|P5|Participant Flow|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1153990|NCT00425373|O6|Outcome|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1153991|NCT00425373|O5|Outcome|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1153992|NCT00425373|O4|Outcome|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1153993|NCT00425373|O3|Outcome|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1153994|NCT00425373|O2|Outcome|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1153995|NCT00425373|O1|Outcome|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1153996|NCT00425373|O9|Outcome|Placebo|4 tablet and 2 capsule placebos taken once daily
1153997|NCT00425373|O8|Outcome|Amlodipine 5 mg|Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
1153998|NCT00425373|O7|Outcome|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
1153999|NCT00425373|O6|Outcome|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1154000|NCT00425373|O5|Outcome|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1154001|NCT00425373|O4|Outcome|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1154002|NCT00425373|O3|Outcome|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1154003|NCT00425373|O2|Outcome|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1154004|NCT00425373|O1|Outcome|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1154005|NCT00425373|O9|Outcome|Placebo|4 tablet and 2 capsule placebos taken once daily
1154006|NCT00425373|O8|Outcome|Amlodipine 5 mg|Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
1154007|NCT00425373|O7|Outcome|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
1154008|NCT00425373|O6|Outcome|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1154009|NCT00425373|O5|Outcome|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1154010|NCT00425373|O4|Outcome|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1154011|NCT00425373|O3|Outcome|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1154012|NCT00425373|O2|Outcome|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1154013|NCT00425373|O1|Outcome|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1154014|NCT00425373|O9|Outcome|Placebo|4 tablet and 2 capsule placebos taken once daily
1154015|NCT00425373|O8|Outcome|Amlodipine 5 mg|Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
1154016|NCT00425373|O7|Outcome|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
1154017|NCT00425373|O6|Outcome|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1154018|NCT00425373|O5|Outcome|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1154019|NCT00425373|O4|Outcome|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1154020|NCT00425373|O3|Outcome|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1154021|NCT00425373|O2|Outcome|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1154022|NCT00425373|O1|Outcome|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1154023|NCT00425373|O9|Outcome|Placebo|4 tablet and 2 capsule placebos taken once daily
1154024|NCT00425373|O8|Outcome|Amlodipine 5 mg|Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
1154025|NCT00425373|O7|Outcome|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
1154026|NCT00425373|O6|Outcome|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1154027|NCT00425373|O5|Outcome|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1154028|NCT00425373|O4|Outcome|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1154029|NCT00425373|O3|Outcome|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1155687|NCT00422695|P2|Participant Flow|Healthy Controls|HIV -free subjects 38 Healthy Controls
1154030|NCT00425373|O2|Outcome|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1154031|NCT00425373|O1|Outcome|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1154032|NCT00425373|E9|Reported Event|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1154033|NCT00425373|E8|Reported Event|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1154034|NCT00425373|E7|Reported Event|Amlodipine 5 mg|Amlodipine 2.5 mg 2 capsules plus 4 tablet placebos taken once daily
1154035|NCT00425373|E6|Reported Event|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1154036|NCT00425373|E5|Reported Event|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1154037|NCT00425373|E4|Reported Event|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
1154038|NCT00425373|E3|Reported Event|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1154039|NCT00425373|E2|Reported Event|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
1154040|NCT00425373|E1|Reported Event|Placebo|4 tablet and 2 capsule placebos taken once daily
1154041|NCT00425308|B3|Baseline|Total|Total of all reporting groups
1154042|NCT00425308|B2|Baseline|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
1154043|NCT00425308|B1|Baseline|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
1154044|NCT00425308|P2|Participant Flow|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
1154045|NCT00425308|P1|Participant Flow|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
1154046|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
1154047|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
1154048|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
1154049|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
1154050|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
1154051|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
1154052|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
1154053|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
1154054|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
1154055|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
1154056|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
1154057|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
1154079|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1155688|NCT00422695|P1|Participant Flow|HIV +|Groups divided according to CD4 counts 105 HIV subjects
1154058|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
1154059|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
1154060|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
1154061|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
1154062|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
1156289|NCT00421993|O1|Outcome|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
1154063|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
1154064|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
1154065|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
1154066|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
1154067|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
1154068|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
1154069|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
1154070|NCT00425308|E2|Reported Event|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
1154071|NCT00425308|E1|Reported Event|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
1154072|NCT00425269|B3|Baseline|Total|Total of all reporting groups
1154073|NCT00425269|B2|Baseline|Control|Control Group (n 97) The women in the control group received one group teaching with the main points after the follow-up tests.
1154074|NCT00425269|B1|Baseline|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154075|NCT00425269|P2|Participant Flow|Control|Control Group (n 97) The women in the control group received one group teaching with the main points after the follow-up tests.
1154076|NCT00425269|P1|Participant Flow|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154077|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154078|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154080|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154081|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154082|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154083|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154084|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154085|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154086|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154087|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154088|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154089|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154090|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154091|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154092|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154093|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154094|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154095|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154096|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154097|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154098|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154099|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154117|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154135|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1156290|NCT00421993|E4|Reported Event|Gel Vehicle|Topical Gel Vehicle
1154100|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154101|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154102|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154103|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154104|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154105|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154106|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154107|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154108|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154109|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154110|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154111|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154112|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154113|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154114|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154115|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154116|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154118|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154119|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154120|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154121|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154122|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154123|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154124|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154125|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154126|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154127|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154128|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154129|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154130|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154131|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154132|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154133|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154134|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154136|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154137|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154138|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154139|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154140|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154141|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154142|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154143|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154144|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154145|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154146|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154147|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154148|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154149|NCT00425269|E2|Reported Event|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
1154150|NCT00425269|E1|Reported Event|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
1154184|NCT00424749|O1|Outcome|Rituximab|The remission induction regimen included oral prednisone and rituximab. Prednisone was started at 1 mg/kg/day for 4 weeks followed by a taper to 0 mg by 6 months. Rituximab 375 mg/m2 intravenously, once a week for 4 weeks was given within 2 weeks of starting steroid therapy.
1154185|NCT00424749|E1|Reported Event|Rituximab|375 mg/m^2/week for 4 weeks
1154186|NCT00424645|B3|Baseline|Total|Total of all reporting groups
1154187|NCT00424645|B2|Baseline|Placebo|Placebo administered IV following Voraxaze arm.
1154188|NCT00424645|B1|Baseline|Voraxaze|Voraxaze administered 50 units/kg intravenously (IV) repeated a maximum of 2 times in a given cycle of chemotherapy.
1154151|NCT00424827|B1|Baseline|This Was a Prospective, Single Arm, Open Label Pilot Phase II|"A Phase II Trial of Cetuximab, Gemcitabine, 5-Fluorouracil, and Radiation Therapy in Locally Advanced Nonmetastatic Pancreatic Adenocarcinoma~This protocol will assess the antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma.~Locally advanced pancreatic cancer is defined as surgically unresectable, but has no evidence of distant metastases. The purpose of this study is to evaluate the efficacy and safety of cetuximab in combination with gemcitabine and 5-FU along with radiation therapy in locally advanced non-resectable, pancreatic adenocarcinoma, using progression free survival as the primary end point."
1154152|NCT00424827|P1|Participant Flow|Single Arm|"This protocol will assess the antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma.~Gemcitabine/Fluorouracil with External Beam Radiation: This protocol will assess the antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma."
1154153|NCT00424827|O1|Outcome|Gemcitabine/Fluorouracil With External Beam Radiation:|
1154154|NCT00424827|O1|Outcome|Gemcitabine/Fluorouracil With External Beam Radiation:|
1154155|NCT00424827|O1|Outcome|Gemcitabine/Fluorouracil With External Beam Radiation:|
1154156|NCT00424827|O1|Outcome|Gemcitabine/Fluorouracil With External Beam Radiation:|
1154157|NCT00424827|O1|Outcome|Gemcitabine/Fluorouracil With External Beam Radiation:|Progression-free survival
1154158|NCT00424827|E1|Reported Event|Gemcitabine/Fluorouracil With External Beam Radiation|antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma.
1154159|NCT00424775|B1|Baseline|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
1154160|NCT00424775|P2|Participant Flow|Vorinostat (400 mg)|This group includes data from all participants who are treated with vorinostat 400 mg once daily consecutive days (14 days) followed by 11 days of rest in the first cycle or 7 days of rest in the second or later cycle. However, no participants received vorinostat 400 mg once daily due to early discontinuation of the study based on the dose limited toxicity on vorinostat 300 mg once daily.
1154161|NCT00424775|P1|Participant Flow|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest in the first cycle or 7 days of rest in the second or later cycle.
1154162|NCT00424775|O1|Outcome|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
1154163|NCT00424775|O1|Outcome|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
1154164|NCT00424775|O1|Outcome|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
1154165|NCT00424775|O1|Outcome|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
1154166|NCT00424775|O1|Outcome|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
1154167|NCT00424775|E1|Reported Event|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
1154168|NCT00424762|B3|Baseline|Total|Total of all reporting groups
1154169|NCT00424762|B2|Baseline|Placebo|blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
1154170|NCT00424762|B1|Baseline|Rosiglitazone|4mg oral tablet once daily titrated to 8mg oral tablet once daily
1154171|NCT00424762|P2|Participant Flow|Placebo|blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
1154172|NCT00424762|P1|Participant Flow|Rosiglitazone|4mg oral tablet once daily titrated to 8mg oral tablet once daily
1154173|NCT00424762|O2|Outcome|Placebo|blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
1154174|NCT00424762|O1|Outcome|Rosiglitazone|4mg oral tablet once daily titrated to 8mg oral tablet once daily
1154175|NCT00424762|O2|Outcome|Placebo|blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
1154176|NCT00424762|O1|Outcome|Rosiglitazone|4mg oral tablet once daily titrated to 8mg oral tablet once daily
1154177|NCT00424762|O2|Outcome|Placebo|blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
1154178|NCT00424762|O1|Outcome|Rosiglitazone|4mg oral tablet once daily titrated to 8mg oral tablet once daily
1154179|NCT00424762|E2|Reported Event|Placebo|blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
1154180|NCT00424762|E1|Reported Event|Rosiglitazone|4mg oral tablet once daily titrated to 8mg oral tablet once daily
1154181|NCT00424749|B1|Baseline|Rituximab|375 mg/m^2/week for 4 weeks
1154182|NCT00424749|P1|Participant Flow|Rituximab|375 mg/m^2/week for 4 weeks
1154183|NCT00424749|O1|Outcome|Rituximab|The remission induction regimen included oral prednisone and rituximab. Prednisone was started at 1 mg/kg/day for 4 weeks followed by a taper to 0 mg by 6 months. Rituximab 375 mg/m2 intravenously, once a week for 4 weeks was given within 2 weeks of starting steroid therapy.
1154190|NCT00424645|P1|Participant Flow|Voraxaze|Voraxaze administered 50 units/kg intravenously (IV) repeated a maximum of 2 times in a given cycle of chemotherapy.
1154191|NCT00424645|O2|Outcome|Placebo|Placebo administered IV following Voraxaze arm.
1154192|NCT00424645|O1|Outcome|Voraxaze|Voraxaze administered 50 units/kg intravenously (IV) repeated a maximum of 2 times in a given cycle of chemotherapy.
1154193|NCT00424645|E2|Reported Event|Placebo|Placebo administered IV following Voraxaze arm.
1154194|NCT00424645|E1|Reported Event|Voraxaze|Voraxaze administered 50 units/kg intravenously (IV) repeated a maximum of 2 times in a given cycle of chemotherapy.
1154195|NCT00424632|B3|Baseline|Total|Total of all reporting groups
1154196|NCT00424632|B2|Baseline|PF-03814735 (Schedule B)|Participants received daily dosing of PF-03814735 of 40, 50, or 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154197|NCT00424632|B1|Baseline|PF-03814735 (Schedule A)|Participants received daily dosing of PF-03814735 of 5, 10, 20, 40, 60, 80, or 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154198|NCT00424632|P10|Participant Flow|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154199|NCT00424632|P9|Participant Flow|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154200|NCT00424632|P8|Participant Flow|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154201|NCT00424632|P7|Participant Flow|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154202|NCT00424632|P6|Participant Flow|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154203|NCT00424632|P5|Participant Flow|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154204|NCT00424632|P4|Participant Flow|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154205|NCT00424632|P3|Participant Flow|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154206|NCT00424632|P2|Participant Flow|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154207|NCT00424632|P1|Participant Flow|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154208|NCT00424632|O2|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154209|NCT00424632|O1|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154210|NCT00424632|O2|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154211|NCT00424632|O1|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154212|NCT00424632|O10|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154213|NCT00424632|O9|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154214|NCT00424632|O8|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154215|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1156444|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
1154216|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154217|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154218|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154219|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154220|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154221|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154222|NCT00424632|O10|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154223|NCT00424632|O9|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154224|NCT00424632|O8|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154225|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154226|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154227|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154228|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154229|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154230|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154231|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154232|NCT00424632|O10|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154233|NCT00424632|O9|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154234|NCT00424632|O8|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154235|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154236|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154237|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154238|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154239|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154240|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154241|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154242|NCT00424632|O2|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154243|NCT00424632|O1|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154244|NCT00424632|O2|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154459|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
1154245|NCT00424632|O1|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154246|NCT00424632|O2|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154247|NCT00424632|O1|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154248|NCT00424632|O11|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154249|NCT00424632|O10|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154250|NCT00424632|O9|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154339|NCT00424619|B2|Baseline|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
1154251|NCT00424632|O8|Outcome|PF-03814735 25 mg (Schedule B)|Participant was randomized to receive daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis. However, participant had reduced dose of 25 mg beginning on Cycle 1 Day 1 of treatment.
1154252|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154253|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154254|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154255|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154256|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154257|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154258|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154259|NCT00424632|O3|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154260|NCT00424632|O2|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154261|NCT00424632|O1|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154262|NCT00424632|O11|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154263|NCT00424632|O10|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154264|NCT00424632|O9|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154265|NCT00424632|O8|Outcome|PF-03814735 25 mg (Schedule B)|Participant was randomized to receive daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis. However, participant had reduced dose of 25 mg beginning on Cycle 1 Day 1 of treatment.
1154266|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154267|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154268|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154269|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154270|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154271|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154272|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1155689|NCT00422695|O2|Outcome|Healthy Controls|HIV -free subjects 38 Healthy Controls
1154273|NCT00424632|O11|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154274|NCT00424632|O10|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154275|NCT00424632|O9|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154276|NCT00424632|O8|Outcome|PF-03814735 25 mg (Schedule B)|Participant was randomized to receive daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis. However, participant had reduced dose of 25 mg beginning on Cycle 1 Day 1 of treatment.
1154277|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154278|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154340|NCT00424619|B1|Baseline|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
1154279|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154280|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154281|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154282|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154283|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154284|NCT00424632|O11|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154285|NCT00424632|O10|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154286|NCT00424632|O9|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154287|NCT00424632|O8|Outcome|PF-03814735 25 mg (Schedule B)|Participant was randomized to receive daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis. However, participant had reduced dose of 25 mg beginning on Cycle 1 Day 1 of treatment.
1154288|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154289|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154290|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154291|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154292|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154293|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154294|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154295|NCT00424632|O11|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154296|NCT00424632|O10|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154297|NCT00424632|O9|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154298|NCT00424632|O8|Outcome|PF-03814735 25 mg (Schedule B)|Participant was randomized to receive daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis. However, participant had reduced dose of 25 mg beginning on Cycle 1 Day 1 of treatment.
1154299|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154300|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154301|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154302|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154303|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154304|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154305|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154306|NCT00424632|O11|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154307|NCT00424632|O10|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154308|NCT00424632|O9|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154309|NCT00424632|O8|Outcome|PF-03814735 25 mg (Schedule B)|Participant was randomized to receive daily dosing of PF-03814735 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis. However, participant had reduced dose of 25 mg beginning on Cycle 1 Day 1 of treatment.
1154310|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154311|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154312|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154313|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154314|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154315|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154316|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154317|NCT00424632|O10|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154318|NCT00424632|O9|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154319|NCT00424632|O8|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154320|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154321|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154322|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154323|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154324|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154325|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154326|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154327|NCT00424632|E10|Reported Event|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154328|NCT00424632|E9|Reported Event|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1154329|NCT00424632|E8|Reported Event|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
1156445|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
1154330|NCT00424632|E7|Reported Event|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154331|NCT00424632|E6|Reported Event|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154332|NCT00424632|E5|Reported Event|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154333|NCT00424632|E4|Reported Event|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154334|NCT00424632|E3|Reported Event|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154335|NCT00424632|E2|Reported Event|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154336|NCT00424632|E1|Reported Event|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
1154341|NCT00424619|P3|Participant Flow|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
1154342|NCT00424619|P2|Participant Flow|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
1154343|NCT00424619|P1|Participant Flow|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
1154344|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
1154345|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
1154346|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
1154347|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
1154348|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
1154349|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
1154350|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
1154351|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
1154352|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
1154353|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
1154354|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
1154355|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
1154356|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
1154357|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
1154358|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
1154359|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
1154360|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
1154361|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
1154362|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
1154363|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
1154364|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
1154365|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
1154366|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
1154367|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
1154368|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
1154369|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
1154370|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
1154371|NCT00424619|E3|Reported Event|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
1154372|NCT00424619|E2|Reported Event|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
1154373|NCT00424619|E1|Reported Event|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
1154374|NCT00424593|B3|Baseline|Total|Total of all reporting groups
1154375|NCT00424593|B2|Baseline|Placebo|every day (QD), by mouth (PO), 13 weeks
1154376|NCT00424593|B1|Baseline|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
1154377|NCT00424593|P2|Participant Flow|Placebo|every day (QD), by mouth (PO), 13 weeks
1154378|NCT00424593|P1|Participant Flow|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
1154460|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
1155690|NCT00422695|O1|Outcome|HIV +|Groups divided according to CD4 counts 105 HIV subjects
1154379|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
1154380|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
1154381|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
1154382|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
1154383|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
1154384|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
1154385|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
1154386|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
1154387|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
1156291|NCT00421993|E3|Reported Event|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
1154388|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
1154389|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
1154390|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
1154391|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
1154392|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
1154393|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
1154394|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
1154395|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
1154396|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
1154397|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
1154398|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
1154399|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
1154400|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
1154401|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
1154402|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
1154403|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
1154404|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
1154405|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
1154406|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
1154407|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
1154408|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
1154409|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
1154410|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
1154411|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
1154412|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
1154413|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
1154461|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
1154414|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
1154415|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
1154416|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
1154417|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
1154418|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
1154419|NCT00424593|E2|Reported Event|Placebo|every day (QD), by mouth (PO), 13 weeks
1154420|NCT00424593|E1|Reported Event|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
1154421|NCT00424554|B3|Baseline|Total|Total of all reporting groups
1154422|NCT00424554|B2|Baseline|No Intervention|No pre-surgery treatment with temozolomide
1154423|NCT00424554|B1|Baseline|Temozolomide (TMZ)|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.~As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
1154424|NCT00424554|P2|Participant Flow|No Intervention|No pre-surgery treatment with temozolomide
1154475|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
1154425|NCT00424554|P1|Participant Flow|Temozolomide (TMZ)|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.~As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
1154426|NCT00424554|O2|Outcome|No Intervention|No pre-surgery treatment with temozolomide
1154427|NCT00424554|O1|Outcome|Temozolomide (TMZ)|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.~As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
1154428|NCT00424554|O2|Outcome|No Intervention|No pre-surgery treatment with temozolomide
1154429|NCT00424554|O1|Outcome|Temozolomide (TMZ)|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.~As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
1154430|NCT00424554|O2|Outcome|No Intervention|No pre-surgery treatment with temozolomide
1154431|NCT00424554|O1|Outcome|Temozolomide (TMZ)|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.~As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
1154432|NCT00424554|O2|Outcome|No Intervention|No pre-surgery treatment with temozolomide
1154433|NCT00424554|O1|Outcome|Temozolomide (TMZ)|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.~As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
1154434|NCT00424554|O2|Outcome|No Intervention|No pre-surgery treatment with temozolomide
1154435|NCT00424554|O1|Outcome|Temozolomide (TMZ)|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.~As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
1154436|NCT00424554|E2|Reported Event|No Intervention|No pre-surgery treatment with temozolomide
1154437|NCT00424554|E1|Reported Event|Temozolomide|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.~As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
1154438|NCT00424528|B4|Baseline|Total|Total of all reporting groups
1154439|NCT00424528|B3|Baseline|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
1154440|NCT00424528|B2|Baseline|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
1154441|NCT00424528|B1|Baseline|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
1154442|NCT00424528|P3|Participant Flow|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
1154443|NCT00424528|P2|Participant Flow|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
1154444|NCT00424528|P1|Participant Flow|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
1154445|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
1154446|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
1154447|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
1154448|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
1154449|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
1154450|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
1154451|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
1154452|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
1154453|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
1154454|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
1154455|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
1154456|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
1154457|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
1154458|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
1154462|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
1154463|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
1154464|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
1154465|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
1154466|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
1154467|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
1154468|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
1154469|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
1154470|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
1154471|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
1154472|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
1154473|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
1154474|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
1156292|NCT00421993|E2|Reported Event|Adapalene Gel|Adapalene Topical Gel
1154476|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
1154477|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
1154478|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
1154479|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
1154480|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
1154481|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
1154482|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
1154483|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
1154484|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
1154485|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
1154486|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
1154487|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
1154488|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
1154489|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
1154490|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
1154491|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
1154492|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
1154493|NCT00424528|E3|Reported Event|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
1154494|NCT00424528|E2|Reported Event|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
1154495|NCT00424528|E1|Reported Event|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
1154496|NCT00424515|B3|Baseline|Total|Total of all reporting groups
1154497|NCT00424515|B2|Baseline|Mutated KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
1154498|NCT00424515|B1|Baseline|Amplified KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
1154499|NCT00424515|P2|Participant Flow|Mutated KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
1154500|NCT00424515|P1|Participant Flow|Amplified KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
1154501|NCT00424515|O2|Outcome|Mutated KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
1154502|NCT00424515|O1|Outcome|Amplified KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
1154503|NCT00424515|O2|Outcome|Mutated KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
1154504|NCT00424515|O1|Outcome|Amplified KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
1154505|NCT00424515|O2|Outcome|Mutated KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
1154506|NCT00424515|O1|Outcome|Amplified KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
1154507|NCT00424515|E2|Reported Event|Mutated KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
1154547|NCT00424398|B3|Baseline|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154508|NCT00424515|E1|Reported Event|Amplified KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
1154509|NCT00424502|B1|Baseline|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
1154510|NCT00424502|P1|Participant Flow|Rituximab 1000 Milligrams (mg)|Participants received rituximab 1000 mg intravenously (IV) and methylprednisolone 100 mg IV on Days 0 and 14.
1154511|NCT00424502|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
1154512|NCT00424502|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
1154513|NCT00424502|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
1154514|NCT00424502|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
1154515|NCT00424502|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
1154516|NCT00424502|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
1154517|NCT00424502|E1|Reported Event|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
1154518|NCT00424476|B4|Baseline|Total|Total of all reporting groups
1154519|NCT00424476|B3|Baseline|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
1154520|NCT00424476|B2|Baseline|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
1154521|NCT00424476|B1|Baseline|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
1154522|NCT00424476|P3|Participant Flow|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
1154523|NCT00424476|P2|Participant Flow|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
1154524|NCT00424476|P1|Participant Flow|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
1154525|NCT00424476|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
1154526|NCT00424476|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
1154527|NCT00424476|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
1154528|NCT00424476|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
1154529|NCT00424476|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
1154530|NCT00424476|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
1154531|NCT00424476|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
1154532|NCT00424476|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
1154533|NCT00424476|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
1154534|NCT00424476|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
1154535|NCT00424476|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
1154536|NCT00424476|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
1154793|NCT00424268|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
1154537|NCT00424476|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
1154538|NCT00424476|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
1154539|NCT00424476|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
1154540|NCT00424476|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
1154541|NCT00424476|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
1154542|NCT00424476|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
1154543|NCT00424476|E3|Reported Event|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
1154544|NCT00424476|E2|Reported Event|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
1154545|NCT00424476|E1|Reported Event|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
1154546|NCT00424398|B4|Baseline|Total|Total of all reporting groups
1155635|NCT00421733|O1|Outcome|Paricalcitol 1 Mcg|One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
1154548|NCT00424398|B2|Baseline|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154549|NCT00424398|B1|Baseline|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154550|NCT00424398|P3|Participant Flow|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154551|NCT00424398|P2|Participant Flow|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154552|NCT00424398|P1|Participant Flow|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154553|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154554|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154555|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154556|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154557|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154558|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154559|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154560|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154561|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154562|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154563|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154564|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154565|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154566|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154567|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154568|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154569|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154570|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154571|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154572|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154794|NCT00424268|O2|Outcome|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
1154573|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154574|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154575|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154576|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154577|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154578|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154579|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154580|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154581|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1155096|NCT00423800|O2|Outcome|Pegetron® - 48 Weeks|Participants are treated for 8 weeks and then randomized to an additional 40 weeks of treatment
1154582|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154583|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154584|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154585|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154586|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154587|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154588|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154589|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154590|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154591|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154592|NCT00424398|E3|Reported Event|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154593|NCT00424398|E2|Reported Event|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154594|NCT00424398|E1|Reported Event|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
1154595|NCT00424385|B1|Baseline|Arm 1|Only 1 arm for the study - this arm gets both drugs, gleevec and sorafenib
1154596|NCT00424385|P1|Participant Flow|Imatinib + Sorafenib|"Both drugs, Gleevec + Sorafenib are given to all patients on study. There are 4 potential cohorts. Each will enroll 3 evaluable (patients that complete 2 cycles of treatment) patients. If a Dose Limiting Toxicity is demonstrated in a cohort, an additional 3 evaluable patients can be enrolled in that cohort.~Cohort 0 was 400mg Sorafenib every day (QD)and 300mg of Imatinib QD. Cohort 1 was 400mg Sorafenib two times a day and 300mg QD Imatinib."
1154597|NCT00424385|O1|Outcome|Imatinib + Sorafenib Cohort 0 & 1|Only 1 arm for the study - this arm gets both drugs, gleevec and sorafenib
1154598|NCT00424385|O1|Outcome|Imatinib + Sorafenib Cohort 0 & 1|Only 1 arm for the study - this arm gets both drugs, gleevec and sorafenib
1154599|NCT00424385|O2|Outcome|Imatinib + Sorafenib Cohort 1|300mg every day (QD) Imatinib + 400mg twice daily (BID)Sorafenib, by mouth
1154600|NCT00424385|O1|Outcome|Imatinib + Sorafenib Cohort 0|300mg every day (QD)Imatinib + 400mg every day (QD) Sorafenib, by mouth
1154601|NCT00424385|E1|Reported Event|Arm 1|Only 1 arm for the study - this arm gets both drugs, gleevec and sorafenib
1154602|NCT00424372|B1|Baseline|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
1154603|NCT00424372|P1|Participant Flow|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
1154739|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
1154604|NCT00424372|O1|Outcome|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
1154605|NCT00424372|O1|Outcome|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
1154606|NCT00424372|O1|Outcome|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
1154607|NCT00424372|O1|Outcome|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
1154608|NCT00424372|O1|Outcome|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
1155097|NCT00423800|O1|Outcome|Pegetron® - 24 Weeks|Participants are treated for 8 weeks and then randomized to an additional 16 weeks of treatment
1154609|NCT00424372|O1|Outcome|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
1154610|NCT00424346|B5|Baseline|Total|Total of all reporting groups
1154611|NCT00424346|B4|Baseline|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154612|NCT00424346|B3|Baseline|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154613|NCT00424346|B2|Baseline|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154614|NCT00424346|B1|Baseline|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
1154615|NCT00424346|P4|Participant Flow|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154616|NCT00424346|P3|Participant Flow|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154617|NCT00424346|P2|Participant Flow|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154618|NCT00424346|P1|Participant Flow|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks. Participants in this treatment group who participated in the Extension Phase are represented in the 'Canakinumab 300 mg q2wk' treatment group in the Extension Phase table below.
1154619|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154620|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154621|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
1154786|NCT00424268|O2|Outcome|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
1154622|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154623|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154624|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
1154625|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154626|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154627|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
1155371|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
1154628|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154629|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154630|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
1154631|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154632|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154633|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
1154634|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154635|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154636|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
1154637|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154638|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154639|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
1154787|NCT00424268|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
1154640|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154641|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154642|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
1154643|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154644|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154645|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
1154646|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154647|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154648|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
1154649|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154650|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154651|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
1154652|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154653|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154654|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
1154655|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154656|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154657|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
1154658|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154659|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154660|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154661|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
1154662|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154663|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154664|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154665|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
1154666|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154667|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154668|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154669|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
1154670|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154671|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154672|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154673|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
1154674|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154675|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154676|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154677|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
1154788|NCT00424268|O2|Outcome|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
1154789|NCT00424268|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
1154678|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154679|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154680|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154681|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
1154682|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154683|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154684|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154769|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
1154685|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
1154686|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154687|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154688|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154689|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
1154690|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154691|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154692|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154693|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
1154694|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154695|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154696|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154697|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
1154698|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154699|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154700|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154701|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
1154702|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154703|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154881|NCT00424177|E2|Reported Event|Cycle 2|Participants received once-daily treatment for up to 6 weeks, followed by up to 4 weeks off-therapy
1155636|NCT00421733|O3|Outcome|Placebo|Two placebo capsules per dose
1154704|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154705|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
1154706|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154707|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154708|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154709|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
1154710|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154711|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154712|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154713|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
1154714|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154715|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154716|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154717|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
1154718|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154719|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154720|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154721|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
1154722|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154882|NCT00424177|E1|Reported Event|Cycle 1|Participants received once-daily treatment for up to 6 weeks, followed by up to 4 weeks off-therapy
1154883|NCT00424047|B3|Baseline|Total|Total of all reporting groups
1154723|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154724|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
1154725|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
1154726|NCT00424346|E4|Reported Event|Placebo|Placebo
1154727|NCT00424346|E3|Reported Event|ACZ885 150mg sc q4wk|ACZ885 150mg sc q4wk
1154728|NCT00424346|E2|Reported Event|ACZ885 300mg sc q2wk|ACZ885 300mg sc q2wk
1154729|NCT00424346|E1|Reported Event|ACZ885 600mg iv + 300mg sc q2wk|ACZ885 600mg iv + 300mg sc q2wk
1154730|NCT00424294|B3|Baseline|Total|Total of all reporting groups
1154731|NCT00424294|B2|Baseline|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
1154732|NCT00424294|B1|Baseline|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
1154733|NCT00424294|P2|Participant Flow|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
1154734|NCT00424294|P1|Participant Flow|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
1154735|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
1154736|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
1154737|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
1154738|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
1154790|NCT00424268|O2|Outcome|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
1154740|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
1154741|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
1154742|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
1154743|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
1154744|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
1154745|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
1154746|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
1154747|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
1154748|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
1154749|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
1154750|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
1154751|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
1154752|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
1154753|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
1154754|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
1154755|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
1154756|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
1154757|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
1154758|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
1154759|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
1154760|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
1154791|NCT00424268|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
1154792|NCT00424268|O2|Outcome|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
1154761|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
1154762|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
1154763|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
1154764|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
1154765|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
1154766|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
1154767|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
1154768|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
1155098|NCT00423800|E3|Reported Event|Pegetron® - 48 Weeks|Participants are treated for 8 weeks with Pegetron® and then randomized to an additional 40 weeks of treatment.
1163357|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1154770|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
1154771|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
1154772|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
1154773|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
1154774|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
1154775|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
1154776|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
1154777|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
1154778|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
1154779|NCT00424294|E2|Reported Event|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
1154780|NCT00424294|E1|Reported Event|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
1154781|NCT00424268|B3|Baseline|Total|Total of all reporting groups
1154782|NCT00424268|B2|Baseline|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
1154783|NCT00424268|B1|Baseline|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
1154784|NCT00424268|P2|Participant Flow|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
1154785|NCT00424268|P1|Participant Flow|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
1154795|NCT00424268|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
1154796|NCT00424268|E2|Reported Event|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
1154797|NCT00424268|E1|Reported Event|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
1154798|NCT00424255|B3|Baseline|Total|Total of all reporting groups
1154799|NCT00424255|B2|Baseline|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154800|NCT00424255|B1|Baseline|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1163358|NCT00402987|O4|Outcome|Placebo|
1154801|NCT00424255|P2|Participant Flow|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154802|NCT00424255|P1|Participant Flow|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154803|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154804|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154805|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154806|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154807|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154808|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154867|NCT00424177|O1|Outcome|Cycle 1|Eltrombopag 50 mg starting dose. Participants whose platelet count was below 50 Gi/L were permitted to increase to eltrombopag 75 mg on or after Day 22.
1154868|NCT00424177|O3|Outcome|Cycle 3|Same dose of eltrombopag at which participants completed Cycle 2 (eltrombopag 50 or 75 mg)
1154809|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154810|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154811|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154884|NCT00424047|B2|Baseline|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
1154812|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154813|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154814|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154815|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154816|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154817|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154818|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154819|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154820|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154821|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154822|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154918|NCT00424021|B1|Baseline|1 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion.
1163359|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
1154823|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154824|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154825|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154826|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154827|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154828|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154829|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154830|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154831|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154832|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154833|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1155099|NCT00423800|E2|Reported Event|Pegetron® - 24 Weeks|Participants are treated for 8 weeks with Pegetron® and then randomized to an additional 16 weeks of treatment.
1155637|NCT00421733|O2|Outcome|Paricalcitol 2 Mcg|Two paricalcitol 1 mcg capsules per dose
1154834|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154835|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154836|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154837|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154838|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154839|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154840|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154841|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154842|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154843|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154844|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1155100|NCT00423800|E1|Reported Event|Screen Failures|Two participants on commercial Pegetron® who were screen fails and were never randomized had SAEs. Both SAEs were are reported here.
1155101|NCT00423735|B4|Baseline|Total|Total of all reporting groups
1154845|NCT00424255|E2|Reported Event|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154846|NCT00424255|E1|Reported Event|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
1154847|NCT00424190|B3|Baseline|Total|Total of all reporting groups
1154848|NCT00424190|B2|Baseline|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours
1154849|NCT00424190|B1|Baseline|Ceftaroline Fosamil for Injection|Ceftaroline fosamil 600 mg administered IV over 60 minutes every 12 hours followed by placebo administered over 60 minutes every 12 hours
1154850|NCT00424190|P2|Participant Flow|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours
1154851|NCT00424190|P1|Participant Flow|Ceftaroline Fosamil for Injection|Ceftaroline fosamil 600 mg administered IV over 60 minutes every 12 hours followed by placebo administered over 60 minutes every 12 hours
1154852|NCT00424190|O2|Outcome|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours
1154853|NCT00424190|O1|Outcome|Ceftaroline Fosamil for Injection|Ceftaroline fosamil 600 mg administered IV over 60 minutes every 12 hours followed by placebo administered over 60 minutes every 12 hours
1154854|NCT00424190|E2|Reported Event|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours
1154855|NCT00424190|E1|Reported Event|Ceftaroline Fosamil for Injection|Ceftaroline fosamil 600 mg administered IV over 60 minutes every 12 hours followed by placebo administered over 60 minutes every 12 hours
1154856|NCT00424177|B1|Baseline|Overall Study Population|Male and female participants greater than or equal to 18 years of age with previously treated chronic ITP, as defined according to the American Society of Hematology/British Committee for Standards in Hematology guidelines, who had platelet counts between greater than or equal to 20 gi/L and less than or equal to 50 Gi/L, on the Day 1 visit (or within 24 hours prior to dosing on Day 1).
1154857|NCT00424177|P1|Participant Flow|Treatment Period|Three cycles of treatment. A cycle is defined as an on-therapy period of up to 6 weeks and an off-therapy period of up to 4 weeks.
1154858|NCT00424177|O3|Outcome|Cycle 3|Same dose of eltrombopag at which participants completed Cycle 2 (eltrombopag 50 or 75 mg)
1154859|NCT00424177|O2|Outcome|Cycle 2|Same dose of eltrombopag at which participants completed Cycle 1 (eltrombopag 50 or 75 mg)
1154860|NCT00424177|O1|Outcome|Cycle 1|Eltrombopag 50 mg starting dose. Participants whose platelet count was below 50 Gi/L were permitted to increase to eltrombopag 75 mg on or after Day 22.
1154861|NCT00424177|O3|Outcome|Cycle 3|Same dose of eltrombopag at which participants completed Cycle 2 (eltrombopag 50 or 75 mg)
1154862|NCT00424177|O2|Outcome|Cycle 2|Same dose of eltrombopag at which participants completed Cycle 1 (eltrombopag 50 or 75 mg)
1154863|NCT00424177|O1|Outcome|Cycle 1|Eltrombopag 50 mg starting dose. Participants whose platelet count was below 50 Gi/L were permitted to increase to eltrombopag 75 mg on or after Day 22.
1154864|NCT00424177|O1|Outcome|Overall Study|
1154865|NCT00424177|O3|Outcome|Cycle 3|Same dose of eltrombopag at which participants completed Cycle 2 (eltrombopag 50 or 75 mg)
1154866|NCT00424177|O2|Outcome|Cycle 2|Same dose of eltrombopag at which participants completed Cycle 1 (eltrombopag 50 or 75 mg)
1154869|NCT00424177|O2|Outcome|Cycle 2|Same dose of eltrombopag at which participants completed Cycle 1 (eltrombopag 50 or 75 mg)
1154870|NCT00424177|O1|Outcome|Cycle 1|Eltrombopag 50 mg starting dose. Participants whose platelet count was below 50 Gi/L were permitted to increase to eltrombopag 75 mg on or after Day 22.
1154871|NCT00424177|O3|Outcome|Cycle 3|Same dose of eltrombopag at which participants completed Cycle 2 (eltrombopag 50 or 75 mg)
1154872|NCT00424177|O2|Outcome|Cycle 2|Same dose of eltrombopag at which participants completed Cycle 1 (eltrombopag 50 or 75 mg)
1154873|NCT00424177|O1|Outcome|Cycle 1|Eltrombopag 50 mg starting dose. Participants whose platelet count was below 50 Gi/L were permitted to increase to eltrombopag 75 mg on or after Day 22.
1154874|NCT00424177|O3|Outcome|Cycle 3|Same dose of eltrombopag at which participants completed Cycle 2 (eltrombopag 50 or 75 mg)
1154875|NCT00424177|O2|Outcome|Cycle 2|Same dose of eltrombopag at which participants completed Cycle 1 (eltrombopag 50 or 75 mg)
1154876|NCT00424177|O1|Outcome|Cycle 1|Eltrombopag 50 mg starting dose. Participants whose platelet count was below 50 Gi/L were permitted to increase to eltrombopag 75 mg on or after Day 22.
1154877|NCT00424177|E6|Reported Event|All Cycles|Participants who reported an AE anytime during 3 cycles of treatment. A cycle consisted of once-daily treatment for up to 6 weeks, followed by up to 4 weeks off-therapy.
1154878|NCT00424177|E5|Reported Event|More Than 30 Days After Last Dose|Adverse events >30 days after last dose (Post-therapy)
1154879|NCT00424177|E4|Reported Event|More Than 1 to 30 Days After Last Dose|Adverse events >1 to 30 days after last dose (Post-therapy)
1154880|NCT00424177|E3|Reported Event|Cycle 3|Participants received once-daily treatment for up to 6 weeks, followed by up to 4 weeks off-therapy
1154885|NCT00424047|B1|Baseline|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
1154886|NCT00424047|P2|Participant Flow|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.~Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.~After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression."
1154887|NCT00424047|P1|Participant Flow|Lenalidomide Plus Dexamethasone (Len/Dex)|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
1154888|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days. Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.~After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression."
1154889|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
1154890|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days. Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.~After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression."
1154891|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
1154892|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
1154893|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
1154894|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days.~Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned. After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression."
1154895|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
1154896|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
1154897|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
1154898|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
1154899|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
1154919|NCT00424021|P4|Participant Flow|10 mg|The optimized final dose from the open-label period of AMB 220 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
1154900|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days. Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.~After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression."
1154901|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
1154902|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days.~Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.~After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression."
1154903|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
1154904|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
1154905|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
1154906|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days.~Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.~After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression."
1154907|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
1154908|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
1154909|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
1154910|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
1154911|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
1154912|NCT00424047|E2|Reported Event|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
1154913|NCT00424047|E1|Reported Event|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
1154914|NCT00424021|B5|Baseline|Total|Total of all reporting groups
1154915|NCT00424021|B4|Baseline|10 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
1154916|NCT00424021|B3|Baseline|5 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
1154917|NCT00424021|B2|Baseline|2.5 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion.
1163360|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
1154920|NCT00424021|P3|Participant Flow|5 mg|The optimized final dose from the open-label period of AMB 220 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
1154921|NCT00424021|P2|Participant Flow|2.5 mg|The optimized final dose from the open-label period of AMB 220 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion.
1154922|NCT00424021|P1|Participant Flow|1 mg|The optimized final dose from the open-label period of AMB 220 (given once daily [QD] by oral administration) was used in this study, with further dose refinement at the investigator’s discretion.
1154923|NCT00424021|O4|Outcome|10 mg|The optimized final dose from the open-label period of AMB 220 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
1154924|NCT00424021|O3|Outcome|5 mg|The optimized final dose from the open-label period of AMB 220 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
1154925|NCT00424021|O2|Outcome|2.5 mg|The optimized final dose from the open-label period of AMB 220 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
1154926|NCT00424021|O1|Outcome|1 mg|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
1154927|NCT00424021|O4|Outcome|10 mg|The optimized final dose from the open-label period of AMB 220 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
1154928|NCT00424021|O3|Outcome|5 mg|The optimized final dose from the open-label period of AMB 220 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
1154929|NCT00424021|O2|Outcome|2.5 mg|The optimized final dose from the open-label period of AMB 220 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
1154930|NCT00424021|O1|Outcome|1 mg|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
1154931|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg once daily by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
1154932|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg once daily by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
1154933|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg once daily by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
1154934|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
1154974|NCT00424008|O1|Outcome|MF/F MDI 200/10 mcg BID|Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
1154935|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
1154936|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
1154937|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
1154938|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg once daily by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group. Results are presented using the LOCF imputation.
1156293|NCT00421993|E1|Reported Event|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
1154939|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
1154940|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
1154941|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
1154942|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
1154943|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg once daily by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group. Results are presented using the LOCF imputation.
1154944|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
1154945|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
1154946|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
1154947|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
1154948|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg once daily by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group. Results are presented using the LOCF imputation.
1154975|NCT00424008|E3|Reported Event|F/SC DPI * 250/50 MCG BID|Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID
1155691|NCT00422695|O2|Outcome|Healthy Controls|HIV -free subjects 38 Healthy Controls
1154949|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
1154950|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
1154951|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
1154952|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
1155080|NCT00423813|P3|Participant Flow|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as 2 equally divided nightly doses
1155081|NCT00423813|P2|Participant Flow|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as 2 equally divided nightly doses
1155082|NCT00423813|P1|Participant Flow|Placebo|Placebo taken as two equally divided nightly doses
1154953|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg once daily by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group. Results are presented using the LOCF imputation.
1154954|NCT00424021|O4|Outcome|10 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
1154955|NCT00424021|O3|Outcome|5 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
1154956|NCT00424021|O2|Outcome|2.5 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
1154957|NCT00424021|O1|Outcome|1 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
1154958|NCT00424021|E4|Reported Event|10 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
1154959|NCT00424021|E3|Reported Event|5 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
1154960|NCT00424021|E2|Reported Event|2.5 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion.
1154961|NCT00424021|E1|Reported Event|1 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion.
1154962|NCT00424008|B3|Baseline|Total|Total of all reporting groups
1154963|NCT00424008|B2|Baseline|F/SC DPI 250/50 mcg BID|Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID
1154964|NCT00424008|B1|Baseline|MF/F MDI 200/10 mcg BID|Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
1154965|NCT00424008|P2|Participant Flow|F/SC DPI 250/50 mcg BID|Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID
1154966|NCT00424008|P1|Participant Flow|MF/F MDI 200/10 mcg BID|Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
1154967|NCT00424008|O2|Outcome|F/SC DPI 250/50 mcg BID|Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID
1154968|NCT00424008|O1|Outcome|MF/F MDI 200/10 mcg BID|Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
1154969|NCT00424008|O2|Outcome|F/SC DPI 250/50 mcg BID|Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID
1154970|NCT00424008|O1|Outcome|MF/F MDI 200/10 mcg BID|Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
1154971|NCT00424008|O2|Outcome|F/SC DPI 250/50 mcg BID|Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID
1154972|NCT00424008|O1|Outcome|MF/F MDI 200/10 mcg BID|Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
1154973|NCT00424008|O2|Outcome|F/SC DPI 250/50 mcg BID|Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID
1155147|NCT00423722|O1|Outcome|Hydration|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
1154976|NCT00424008|E2|Reported Event|MF/F MDI * 200/10 MCG * BID|Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
1154977|NCT00424008|E1|Reported Event|Open-label (OL) MF MDI * 200 MCG BID|Mometasone furoate 200 mcg taken twice daily (BID) via a metered-dose inhaler (MDI).
1154978|NCT00423917|B1|Baseline|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
1154979|NCT00423917|P1|Participant Flow|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
1155083|NCT00423813|O3|Outcome|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as 2 equally divided nightly doses
1155084|NCT00423813|O2|Outcome|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as 2 equally divided nightly doses
1154980|NCT00423917|O1|Outcome|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
1154981|NCT00423917|O1|Outcome|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
1154982|NCT00423917|O1|Outcome|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
1154983|NCT00423917|O1|Outcome|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
1154984|NCT00423917|O1|Outcome|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
1154985|NCT00423917|O1|Outcome|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
1154986|NCT00423917|O1|Outcome|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
1155148|NCT00423722|E2|Reported Event|Placebo|Change Between Day 4 and Baseline
1155149|NCT00423722|E1|Reported Event|Hydration|Change Between Day 4 and Baseline
1155150|NCT00423683|B3|Baseline|Total|Total of all reporting groups
1154987|NCT00423917|E1|Reported Event|Fulvestrant + Bevacizumab|Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
1154988|NCT00423891|B4|Baseline|Total|Total of all reporting groups
1154989|NCT00423891|B3|Baseline|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
1154990|NCT00423891|B2|Baseline|Lamivudine (LVD)-Experienced (Group B)|Participants with greater than (>) 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155085|NCT00423813|O1|Outcome|Placebo|Placebo taken as two equally divided nightly doses
1155086|NCT00423813|E3|Reported Event|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as 2 equally divided nightly doses
1156294|NCT00421954|B1|Baseline|Ziprasidone|Ziprasidone: subjects will use ziprasidone
1154991|NCT00423891|B1|Baseline|Lamivudine (LVD)-Naive (Group A)|Participants with less than (<) 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to Pharmacokinetic (PK) assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1154992|NCT00423891|P3|Participant Flow|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
1154993|NCT00423891|P2|Participant Flow|Lamivudine (LVD)-Experienced (Group B)|Participants with greater than (>) 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1154994|NCT00423891|P1|Participant Flow|Lamivudine (LVD)-Naive (Group A)|Participants with less than (<) 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to Pharmacokinetic (PK) assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1154995|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
1154996|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1154997|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155151|NCT00423683|B2|Baseline|1- Arixtra Alone|Arixtra treatment without inferior vena cava filter
1155152|NCT00423683|B1|Baseline|2 Arixtra+ Filter|Arixtra subq injection + IVC filter
1155153|NCT00423683|P2|Participant Flow|1-Arixtra Alone|Arixtra treatment without inferior vena cava filter
1154998|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
1154999|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155000|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155001|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
1155087|NCT00423813|E2|Reported Event|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as 2 equally divided nightly doses
1155088|NCT00423813|E1|Reported Event|Placebo|Placebo taken as two equally divided nightly doses
1155002|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155003|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155004|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
1155005|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155006|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155007|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
1155008|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155154|NCT00423683|P1|Participant Flow|2 Arixtra+ Filter|Arixtra subq injection + IVC filter
1155009|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155010|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
1155011|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155012|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155089|NCT00423800|B3|Baseline|Total|Total of all reporting groups
1155090|NCT00423800|B2|Baseline|Pegetron® - 48 Weeks|Participants are treated for 8 weeks and then randomized to an additional 40 weeks of treatment
1155013|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
1155014|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155015|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155016|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
1155017|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155018|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155019|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
1155155|NCT00423683|O2|Outcome|Arm 2 Arixtra + IVC Filter|
1155020|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155021|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155022|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
1155023|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155091|NCT00423800|B1|Baseline|Pegetron® - 24 Weeks|Participants are treated for 8 weeks and then randomized to an additional 16 weeks of treatment
1155092|NCT00423800|P2|Participant Flow|Pegetron® - 48 Weeks|Participants are treated for 8 weeks and then randomized to an additional 40 weeks of treatment
1155024|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155025|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
1155026|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155027|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155028|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
1155029|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155041|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155030|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155031|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
1155032|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155033|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155034|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
1155093|NCT00423800|P1|Participant Flow|Pegetron® - 24 Weeks|Participants are treated for 8 weeks and then randomized to an additional 16 weeks of treatment
1155094|NCT00423800|O2|Outcome|Pegetron® - 48 Weeks|Participants are treated for 8 weeks and then randomized to an additional 40 weeks of treatment
1155035|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155036|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155037|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
1155038|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155039|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155040|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
1155042|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155043|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
1155044|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155045|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155095|NCT00423800|O1|Outcome|Pegetron® - 24 Weeks|Participants are treated for 8 weeks and then randomized to an additional 16 weeks of treatment
1156295|NCT00421954|P1|Participant Flow|Ziprasidone|Ziprasidone: subjects will use ziprasidone
1155046|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
1155047|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155048|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155049|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155050|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155051|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with greater than (>) 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155112|NCT00423735|O2|Outcome|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
1155156|NCT00423683|O1|Outcome|Arm 1 Arixtra|
1155157|NCT00423683|O2|Outcome|Arm 2 Arixtra + IVC Filter|
1155052|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155053|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with greater than (>) 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155054|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with less than (<) 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to Pharmacokinetic (PK) assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155055|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with greater than (>) 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155056|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with less than (<) 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to Pharmacokinetic (PK) assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155057|NCT00423891|E3|Reported Event|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
1155058|NCT00423891|E2|Reported Event|Lamivudine (LVD)-Experienced (Group B)|Participants with greater than (>) 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155059|NCT00423891|E1|Reported Event|Lamivudine (LVD)-Naive (Group A)|Participants with less than (<) 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to Pharmacokinetic (PK) assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
1155060|NCT00423878|B3|Baseline|Total|Total of all reporting groups
1155061|NCT00423878|B2|Baseline|Stay Group|Participants will continue treatment with olanzapine, quetiapine, or risperidone.
1155062|NCT00423878|B1|Baseline|Switch Group|Participants will switch to aripiprazole.
1155063|NCT00423878|P2|Participant Flow|Stay Group|Participants will continue with their current antipsychotic treatment, either olanzapine 5-20 mg/day, quetiapine 200-1200 mg/day, or risperidone 1-16 mg/day.
1155064|NCT00423878|P1|Participant Flow|Switch Group|Participants will switch to aripiprazole with a cross-titration from the current antipsychotic over 3-4 weeks. Allowed final dosage range for aripiprazole was 5-30 mg/day.
1155065|NCT00423878|O2|Outcome|Stay Group|Participants will continue treatment with olanzapine, quetiapine, or risperidone.
1155066|NCT00423878|O1|Outcome|Switch Group|Participants will switch to aripiprazole.
1155067|NCT00423878|O2|Outcome|Stay Group|Participants will continue treatment with olanzapine, quetiapine, or risperidone.
1155068|NCT00423878|O1|Outcome|Switch Group|Participants will switch to aripiprazole.
1155069|NCT00423878|E2|Reported Event|Stay Group|Participants will continue treatment with olanzapine, quetiapine, or risperidone.
1155070|NCT00423878|E1|Reported Event|Switch Group|Participants will switch to aripiprazole.
1155113|NCT00423735|O1|Outcome|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.
1155158|NCT00423683|O1|Outcome|Arm 1 Arixtra|
1155159|NCT00423683|O2|Outcome|Arm 2 Arixtra + IVC Filter|
1155160|NCT00423683|O1|Outcome|Arm 1 Arixtra|
1155071|NCT00423852|B1|Baseline|Chemotherapy With Stem Cell Support|"This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.~filgrastim~carboplatin~ifosfamide~paclitaxel~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
1155072|NCT00423852|P1|Participant Flow|Chemotherapy With Stem Cell Support|"This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.~filgrastim~carboplatin~ifosfamide~paclitaxel~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
1155073|NCT00423852|O1|Outcome|Chemotherapy With Stem Cell Support|"This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.~filgrastim~carboplatin~ifosfamide~paclitaxel~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
1155074|NCT00423852|O1|Outcome|Chemotherapy With Stem Cell Support|"This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.~filgrastim~carboplatin~ifosfamide~paclitaxel~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
1155075|NCT00423852|E1|Reported Event|Chemotherapy With Stem Cell Support|"This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.~filgrastim~carboplatin~ifosfamide~paclitaxel~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
1155076|NCT00423813|B4|Baseline|Total|Total of all reporting groups
1155077|NCT00423813|B3|Baseline|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as 2 equally divided nightly doses
1155078|NCT00423813|B2|Baseline|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as 2 equally divided nightly doses
1155079|NCT00423813|B1|Baseline|Placebo|Placebo taken as two equally divided nightly doses
1163361|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1155102|NCT00423735|B3|Baseline|Stage 2: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
1155103|NCT00423735|B2|Baseline|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
1155104|NCT00423735|B1|Baseline|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.
1155105|NCT00423735|P3|Participant Flow|Stage 2: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
1155106|NCT00423735|P2|Participant Flow|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
1155107|NCT00423735|P1|Participant Flow|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity
1155108|NCT00423735|O2|Outcome|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
1155109|NCT00423735|O1|Outcome|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.
1155110|NCT00423735|O2|Outcome|Progressive Disease|"Patients with best tumor response of progressive disease by six months. Progressive disease (PD): ≥ 25% increase in the size of enhancing tumor or any new tumor, neurologically worse, or steroids stable/increased."
1155111|NCT00423735|O1|Outcome|Stable Disease|"Patients with best response of stable disease by six months. Stable disease (SD): Does not qualify for CR, PR, or PD. Progressive disease (PD): ≥ 25% increase in the size of enhancing tumor or any new tumor, neurologically worse, or steroids stable/increased."
1155145|NCT00423722|O1|Outcome|Hydration (Baseline and Day 4)|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
1155146|NCT00423722|O2|Outcome|Placebo|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
1155114|NCT00423735|O2|Outcome|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
1155115|NCT00423735|O1|Outcome|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity
1155116|NCT00423735|O2|Outcome|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
1155117|NCT00423735|O1|Outcome|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity
1155118|NCT00423735|O2|Outcome|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
1155119|NCT00423735|O1|Outcome|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity
1155120|NCT00423735|O2|Outcome|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
1155121|NCT00423735|O1|Outcome|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity
1155122|NCT00423735|O3|Outcome|Stage 2:|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity
1155123|NCT00423735|O2|Outcome|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
1155124|NCT00423735|O1|Outcome|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.
1155200|NCT00423670|O2|Outcome|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
1156296|NCT00421954|O1|Outcome|Ziprasidone|Ziprasidone: subjects will use ziprasidone
1155125|NCT00423735|E2|Reported Event|Stage 1B: Dasatinib up to 400mg/Day|"Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.~dasatinib: Given orally"
1155126|NCT00423735|E1|Reported Event|Stage 1: Dasatinib 200mg/Day|"Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity~dasatinib: Given orally"
1155127|NCT00423722|B3|Baseline|Total|Total of all reporting groups
1155128|NCT00423722|B2|Baseline|Placebo: Lower Saline|Group 2: Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
1155129|NCT00423722|B1|Baseline|Hydration: Normal Saline (Salt Water)|Group 1: 1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
1155130|NCT00423722|P2|Participant Flow|Placebo: Lower Saline|Group 2: Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
1155131|NCT00423722|P1|Participant Flow|Hydration: Normal Saline (Salt Water)|Group 1: 1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
1155132|NCT00423722|O4|Outcome|Placebo (Baseline and Day 7)|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
1155133|NCT00423722|O3|Outcome|Hydration (Baseline and Day 7)|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
1155134|NCT00423722|O2|Outcome|Placebo (Baseline and Day 4)|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
1155135|NCT00423722|O1|Outcome|Hydration (Baseline and Day 4)|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
1155136|NCT00423722|O4|Outcome|Placebo (Baseline and Day 7)|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
1155137|NCT00423722|O3|Outcome|Hydration (Baseline and Day 7)|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
1155138|NCT00423722|O2|Outcome|Placebo (Baseline and Day 4)|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
1155139|NCT00423722|O1|Outcome|Hydration (Baseline and Day 4)|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
1155140|NCT00423722|O2|Outcome|Placebo (Baseline and Day 7)|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
1155141|NCT00423722|O1|Outcome|Hydration (Baseline and Day 7)|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
1155142|NCT00423722|O4|Outcome|Placebo (Baseline and Day 7)|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
1155143|NCT00423722|O3|Outcome|Hydration (Baseline and Day 7)|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
1155144|NCT00423722|O2|Outcome|Placebo (Baseline and Day 4)|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
1155166|NCT00423670|B7|Baseline|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
1155167|NCT00423670|B6|Baseline|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
1155168|NCT00423670|B5|Baseline|Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
1155169|NCT00423670|B4|Baseline|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
1155170|NCT00423670|B3|Baseline|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
1155171|NCT00423670|B2|Baseline|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
1155372|NCT00423319|O1|Outcome|Apixiban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
1155172|NCT00423670|B1|Baseline|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.~• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks."
1155173|NCT00423670|P8|Participant Flow|Arm 8. PEG + RBV + BOC (From Wk 24) for 48 Wks (Part I)|Participants that started in Arm 1 and had detectable HCV-RNA levels after 24 weeks of treatment had the option of receiving boceprevir (800 mg TID) with PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day). Participants that took the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg TID) for 24 additional weeks constitute Arm 8. The total treatment duration was up to 54 weeks.
1155174|NCT00423670|P7|Participant Flow|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
1155175|NCT00423670|P6|Participant Flow|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
1155176|NCT00423670|P5|Participant Flow|Arm 5. PEG + RBV + BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
1155177|NCT00423670|P4|Participant Flow|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
1155178|NCT00423670|P3|Participant Flow|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
1155179|NCT00423670|P2|Participant Flow|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
1155180|NCT00423670|P1|Participant Flow|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg, once weekly [QW]) plus ribavirin (800 to 1400 mg/day) for 48 weeks.~• Participants with detectable HCV-RNA levels after 24 weeks of treatment had the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg, thrice a day [TID]) for 24 additional weeks. Total treatment duration was up to 54 weeks."
1155181|NCT00423670|O7|Outcome|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
1155182|NCT00423670|O6|Outcome|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
1155183|NCT00423670|O5|Outcome|Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
1155184|NCT00423670|O4|Outcome|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
1155185|NCT00423670|O3|Outcome|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
1155186|NCT00423670|O2|Outcome|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
1155187|NCT00423670|O1|Outcome|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.~• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks."
1155188|NCT00423670|O7|Outcome|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
1155189|NCT00423670|O6|Outcome|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
1155190|NCT00423670|O5|Outcome|Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
1155191|NCT00423670|O4|Outcome|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
1155192|NCT00423670|O3|Outcome|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
1155193|NCT00423670|O2|Outcome|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
1155194|NCT00423670|O1|Outcome|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.~• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks."
1155195|NCT00423670|O7|Outcome|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
1155196|NCT00423670|O6|Outcome|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
1155197|NCT00423670|O5|Outcome|Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
1155198|NCT00423670|O4|Outcome|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
1155199|NCT00423670|O3|Outcome|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
1163362|NCT00402987|O3|Outcome|Placebo|
1155201|NCT00423670|O1|Outcome|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.~• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks."
1155202|NCT00423670|O7|Outcome|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
1155203|NCT00423670|O6|Outcome|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
1155204|NCT00423670|O5|Outcome|Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
1155205|NCT00423670|O4|Outcome|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
1155206|NCT00423670|O3|Outcome|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
1155207|NCT00423670|O2|Outcome|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
1155208|NCT00423670|O1|Outcome|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.~• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks."
1155209|NCT00423670|O7|Outcome|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
1155210|NCT00423670|O6|Outcome|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
1155211|NCT00423670|O5|Outcome|Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
1155212|NCT00423670|O4|Outcome|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
1155213|NCT00423670|O3|Outcome|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
1155214|NCT00423670|O2|Outcome|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
1155215|NCT00423670|O1|Outcome|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.~• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks."
1155216|NCT00423670|O2|Outcome|Arm 2 and Arm 3. PEG + RBV + BOC (28 Weeks)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) with or without a 4 weeks lead with boceprevir (800 mg TID) for 28 weeks.
1155217|NCT00423670|O1|Outcome|Arm 4 and Arm 5. PEG + RBV + BOC (48 Weeks)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) with or without a 4 weeks lead with boceprevir (800 mg TID) for 48 weeks.
1155218|NCT00423670|O2|Outcome|Arm 2 and Arm 4. PEG + RBV + BOC|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
1155219|NCT00423670|O1|Outcome|Arm 3 and Arm 5. PEG + RBV + BOC (From Wk 4)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
1155220|NCT00423670|O7|Outcome|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
1155221|NCT00423670|O6|Outcome|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
1155222|NCT00423670|O5|Outcome|Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
1155223|NCT00423670|O4|Outcome|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
1155361|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
1155224|NCT00423670|O3|Outcome|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
1155225|NCT00423670|O2|Outcome|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
1155226|NCT00423670|O1|Outcome|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.~• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks."
1155227|NCT00423670|E8|Reported Event|PEG + RBV + BOC (From Wk 24) for 48 Wks (Part I)|Arm 8. Participants that started in Arm 1 and had detectable HCV-RNA levels after 24 weeks of treatment had the option of receiving boceprevir (800 mg TID) with PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day). Participants that took the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg TID) for 24 additional weeks constitute Arm 8. The total treatment duration was up to 54 weeks.
1155228|NCT00423670|E7|Reported Event|PEG +Low-dose RBV + BOC for 48 Wks (Part II)|Arm 7. PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
1155229|NCT00423670|E6|Reported Event|PEG + RBV + BOC for 48 Wks (Part II)|Arm 6. PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
1155230|NCT00423670|E5|Reported Event|PEG + RBV + BOC (From Wk 4) for 44 Wks (Part I)|Arm 5. PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
1155231|NCT00423670|E4|Reported Event|PEG +RBV + BOC for 48 Wks (Part I)|Arm 4. Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
1155232|NCT00423670|E3|Reported Event|PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|Arm 3. PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
1155233|NCT00423670|E2|Reported Event|PEG + RBV + BOC for 28 Wks (Part I)|Arm 2. Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
1155234|NCT00423670|E1|Reported Event|PEG +RBV for 48 Wks (Part I)|"Arm 1. PegIntron (1.5 μg/kg, once weekly [QW]) plus ribavirin (800 to 1400 mg/day) for 48 weeks.~• Participants with detectable HCV-RNA levels after 24 weeks of treatment had the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg, thrice a day [TID]) for 24 additional weeks. Total treatment duration was up to 54 weeks.~Adverse events for 36 participants after they crossed over to Arm 8 are not included."
1155235|NCT00423657|B3|Baseline|Total|Total of all reporting groups
1155236|NCT00423657|B2|Baseline|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.
1155237|NCT00423657|B1|Baseline|Ceftaroline for Injection|Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
1155238|NCT00423657|P2|Participant Flow|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.
1155239|NCT00423657|P1|Participant Flow|Ceftaroline for Injection|Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
1155240|NCT00423657|O2|Outcome|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.
1155241|NCT00423657|O1|Outcome|Ceftaroline for Injection|Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
1155242|NCT00423657|E2|Reported Event|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.
1155243|NCT00423657|E1|Reported Event|Ceftaroline for Injection|Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
1155244|NCT00423605|B1|Baseline|Xyrem 4.5 g to 9.0 g|Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses
1155245|NCT00423605|P1|Participant Flow|Xyrem 4.5 g to 9.0 g|Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses
1155246|NCT00423605|O1|Outcome|Xyrem 4.5 g to 9.0 g|Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses
1155247|NCT00423605|E1|Reported Event|Xyrem 4.5 g to 9.0 g|Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses
1155248|NCT00423592|B1|Baseline|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
1155249|NCT00423592|P1|Participant Flow|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
1155250|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
1155251|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
1155252|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
1156446|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
1155253|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
1155254|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
1155255|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
1155256|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
1155257|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
1155316|NCT00423436|P1|Participant Flow|IVR Assessment Plus Triage|Interactive Voice Response Telephone System (IVR) Plus Triage (Participants report symptoms to telephone system and doctor/nurse notified when symptom is severe) + Questionnaire
1155258|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
1155259|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
1155260|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
1155261|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
1155262|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
1155263|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
1155264|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
1155265|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
1155266|NCT00423592|E1|Reported Event|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
1155267|NCT00423579|B3|Baseline|Total|Total of all reporting groups
1155268|NCT00423579|B2|Baseline|Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg|Subjects in the Intent-to-Treat population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment.
1155269|NCT00423579|B1|Baseline|Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo|Subjects in the Intent-to-Treat Population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment
1155270|NCT00423579|P2|Participant Flow|Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg|Subjects in the Intent-to-Treat population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment.
1155271|NCT00423579|P1|Participant Flow|Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo|Subjects in the Intent-to-Treat Population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment
1155272|NCT00423579|O2|Outcome|Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg|Subjects in the Intent-to-Treat population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment.
1155273|NCT00423579|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo|Subjects in the Intent-to-Treat Population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment
1155274|NCT00423579|E2|Reported Event|Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg|Subjects in the Intent-to-Treat population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment.
1155275|NCT00423579|E1|Reported Event|Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo|Subjects in the Intent-to-Treat Population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment
1155276|NCT00423488|B3|Baseline|Total|Total of all reporting groups
1155277|NCT00423488|B2|Baseline|Ezetimibe Placebo + Simvastatin 40 mg|Participants were instructed to take one ezetimibe placebo tablet and one simvastatin 20-mg tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
1155278|NCT00423488|B1|Baseline|Ezetimibe 10 mg + Simvastatin Placebo + Simvastatin 20 mg|Participants were instructed to take one 10-mg ezetimibe tablet and one simvastatin placebo tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
1155279|NCT00423488|P2|Participant Flow|Ezetimibe Placebo + Simvastatin 40 mg|Participants were instructed to take one ezetimibe placebo tablet and one simvastatin 20-mg tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
1155280|NCT00423488|P1|Participant Flow|Ezetimibe 10 mg + Simvastatin Placebo + Simvastatin 20 mg|Participants were instructed to take one 10-mg ezetimibe tablet and one simvastatin placebo tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
1155281|NCT00423488|O2|Outcome|Ezetimibe Placebo + Simvastatin 40 mg|Participants were instructed to take one ezetimibe placebo tablet and one simvastatin 20-mg tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
1155282|NCT00423488|O1|Outcome|Ezetimibe 10 mg + Simvastatin Placebo + Simvastatin 20 mg|Participants were instructed to take one 10-mg ezetimibe tablet and one simvastatin placebo tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
1155317|NCT00423436|O2|Outcome|IVR Assessment Only|IVR (Phone calls twice weekly) + Questionnaire
1155283|NCT00423488|E2|Reported Event|Ezetimibe Placebo + Simvastatin 40 mg|Participants were instructed to take one ezetimibe placebo tablet and one simvastatin 20-mg tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
1155284|NCT00423488|E1|Reported Event|Ezetimibe 10 mg + Simvastatin Placebo + Simvastatin 20 mg|Participants were instructed to take one 10-mg ezetimibe tablet and one simvastatin placebo tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
1155285|NCT00423449|B1|Baseline|All Participants|Vorinostat + Gemcitabine + Cisplatin
1155286|NCT00423449|P5|Participant Flow|Vorinostat 400 14/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 14 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
1155287|NCT00423449|P4|Participant Flow|Vorinostat 400 10/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 10 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
1155288|NCT00423449|P3|Participant Flow|Vorinostat 400 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
1155289|NCT00423449|P2|Participant Flow|Vorinostat 300 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
1155290|NCT00423449|P1|Participant Flow|Vorinostat 300 7/21+ Gemcitabine 1000 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1000 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
1155291|NCT00423449|O1|Outcome|All Participants|Vorinostat + Gemcitabine + Cisplatin
1155292|NCT00423449|O5|Outcome|Vorinostat 400 14/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 14 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
1155293|NCT00423449|O4|Outcome|Vorinostat 400 10/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 10 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
1155294|NCT00423449|O3|Outcome|Vorinostat 400 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
1155295|NCT00423449|O2|Outcome|Vorinostat 300 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
1155296|NCT00423449|O1|Outcome|Vorinostat 300 7/21+ Gemcitabine 1000 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1000 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
1155297|NCT00423449|O5|Outcome|Vorinostat 400 14/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 14 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
1155298|NCT00423449|O4|Outcome|Vorinostat 400 10/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 10 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
1155299|NCT00423449|O3|Outcome|Vorinostat 400 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
1155300|NCT00423449|O2|Outcome|Vorinostat 300 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
1155301|NCT00423449|O1|Outcome|Vorinostat 300 7/21+ Gemcitabine 1000 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1000 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
1155302|NCT00423449|O5|Outcome|Vorinostat 400 14/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 14 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
1155303|NCT00423449|O4|Outcome|Vorinostat 400 10/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 10 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
1156447|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
1155304|NCT00423449|O3|Outcome|Vorinostat 400 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
1155305|NCT00423449|O2|Outcome|Vorinostat 300 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
1155306|NCT00423449|O1|Outcome|Vorinostat 300 7/21+ Gemcitabine 1000 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1000 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
1155307|NCT00423449|E5|Reported Event|MK-0683 400 mg 14d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin|
1155308|NCT00423449|E4|Reported Event|MK-0683 400 mg 10d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin|
1155309|NCT00423449|E3|Reported Event|MK-0683 400 mg 7d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin|
1155310|NCT00423449|E2|Reported Event|MK-0683 300 mg 7d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin|
1155311|NCT00423449|E1|Reported Event|MK-0683 300 mg x 7d/21d + Gemcitabine 1000 mg/m^2 + Cisplatin|
1155312|NCT00423436|B3|Baseline|Total|Total of all reporting groups
1155313|NCT00423436|B2|Baseline|IVR Assessment Only|IVR (Phone calls twice weekly) + Questionnaire
1155314|NCT00423436|B1|Baseline|IVR Assessment Plus Triage|Interactive Voice Response Telephone System (IVR) Plus Triage (Participants report symptoms to telephone system and doctor/nurse notified when symptom is severe) + Questionnaire
1155315|NCT00423436|P2|Participant Flow|IVR Assessment Only|IVR (Phone calls twice weekly) + Questionnaire
1155318|NCT00423436|O1|Outcome|IVR Assessment Plus Triage|Interactive Voice Response Telephone System (IVR) Plus Triage (Participants report symptoms to telephone system and doctor/nurse notified when symptom is severe) + Questionnaire
1155319|NCT00423436|E2|Reported Event|IVR Assessment Only|IVR (Phone calls twice weekly) + Questionnaire
1155320|NCT00423436|E1|Reported Event|IVR Assessment Plus Triage|Interactive Voice Response Telephone System (IVR) Plus Triage (Participants report symptoms to telephone system and doctor/nurse notified when symptom is severe) + Questionnaire
1155321|NCT00423358|B3|Baseline|Total|Total of all reporting groups
1155322|NCT00423358|B2|Baseline|Placebo|"matching placebo tablet~placebo: matching placebo"
1155323|NCT00423358|B1|Baseline|Vitamin D|"ergocalciferol 50,000 IU Twice monthly~Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year"
1155324|NCT00423358|P2|Participant Flow|Placebo|"matching placebo tablet~placebo: matching placebo"
1155325|NCT00423358|P1|Participant Flow|Vitamin D|"ergocalciferol 50,000 IU Twice monthly~Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year"
1155326|NCT00423358|O2|Outcome|Placebo, n=11|"matching placebo tablet~placebo: matching placebo"
1155327|NCT00423358|O1|Outcome|Vitamin D, n=11|"ergocalciferol 50,000 IU Twice monthly~Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year"
1155328|NCT00423358|O2|Outcome|Placebo, n=11|"matching placebo tablet~placebo: matching placebo"
1155329|NCT00423358|O1|Outcome|Vitamin D, n=11|"ergocalciferol 50,000 IU Twice monthly~Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year"
1155330|NCT00423358|O2|Outcome|Placebo, n=11|"matching placebo tablet~placebo: matching placebo"
1155331|NCT00423358|O1|Outcome|Vitamin D, n=11|"ergocalciferol 50,000 IU Twice monthly~Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year"
1155332|NCT00423358|E2|Reported Event|Placebo, n=11|"matching placebo tablet~placebo: matching placebo"
1155333|NCT00423358|E1|Reported Event|Vitamin D, n=11|"ergocalciferol 50,000 IU Twice monthly~Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year"
1155334|NCT00423332|B3|Baseline|Total|Total of all reporting groups
1155335|NCT00423332|B2|Baseline|Placebo|Placebo/Day
1155336|NCT00423332|B1|Baseline|AZD2171 45 mg|AZD2171 45mg/Day
1155337|NCT00423332|P2|Participant Flow|Placebo|Placebo / Day: 18 patients randomised
1155338|NCT00423332|P1|Participant Flow|AZD2171 45 mg|AZD2171 45mg/Day: 53 patients randomised
1155339|NCT00423332|O2|Outcome|Placebo|Placebo/Day
1155340|NCT00423332|O1|Outcome|AZD2171 45 mg|AZD2171 45mg/Day
1155341|NCT00423332|O2|Outcome|Placebo|Placebo/Day
1155342|NCT00423332|O1|Outcome|AZD2171 45 mg|AZD2171 45mg/Day
1155343|NCT00423332|O2|Outcome|Placebo|Placebo/Day
1155344|NCT00423332|O1|Outcome|AZD2171 45 mg|AZD2171 45mg/Day
1155345|NCT00423332|O2|Outcome|Placebo|Placebo/Day
1155346|NCT00423332|O1|Outcome|AZD2171 45 mg|AZD2171 45mg/Day
1155347|NCT00423332|O2|Outcome|Placebo|Placebo/Day
1155348|NCT00423332|O1|Outcome|AZD2171 45 mg|AZD2171 45mg/Day
1155349|NCT00423332|O2|Outcome|Placebo|Placebo/Day
1155350|NCT00423332|O1|Outcome|AZD2171 45 mg|AZD2171 45mg/Day
1155351|NCT00423332|E3|Reported Event|Cediranib OL|Open Label part
1155352|NCT00423332|E2|Reported Event|Placebo DB|Double Blind part
1155353|NCT00423332|E1|Reported Event|Cediranib DB|Double Blind part
1155354|NCT00423319|B3|Baseline|Total|Total of all reporting groups
1155355|NCT00423319|B2|Baseline|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
1155356|NCT00423319|B1|Baseline|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
1155357|NCT00423319|P2|Participant Flow|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
1155358|NCT00423319|P1|Participant Flow|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
1155359|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
1155360|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
1155692|NCT00422695|O1|Outcome|HIV +|Groups divided according to CD4 counts 105 HIV subjects
1155362|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
1155363|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
1155364|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
1155365|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
1155366|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
1155367|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
1155368|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
1155369|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
1155370|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
1155638|NCT00421733|O1|Outcome|Paricalcitol 1 Mcg|One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
1155373|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
1155374|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
1155375|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
1155376|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
1155377|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
1155378|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
1155379|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
1155380|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
1155381|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
1155382|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
1155383|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
1155384|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
1155385|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
1155386|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
1155387|NCT00423319|E2|Reported Event|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
1155388|NCT00423319|E1|Reported Event|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
1155389|NCT00423293|B1|Baseline|5-FU + Mitomycin + IMRT|5-FU + Mitomycin + IMRT
1155390|NCT00423293|P1|Participant Flow|5-FU + Mitomycin + IMRT|5-FU + Mitomycin + IMRT
1155391|NCT00423293|O1|Outcome|5-FU + Mitomycin + IMRT|5-FU + Mitomycin + IMRT
1155392|NCT00423293|E1|Reported Event|5-FU + Mitomycin + IMRT|5-FU + Mitomycin + IMRT
1155393|NCT00423267|B3|Baseline|Total|Total of all reporting groups
1155394|NCT00423267|B2|Baseline|Fluconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A. Participants in this arm were given posaconazole in Period B.
1155395|NCT00423267|B1|Baseline|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
1155396|NCT00423267|P2|Participant Flow|Fluconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A. Participants in this arm were given posaconazole in Period B.
1155397|NCT00423267|P1|Participant Flow|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months. One subject from period A declined to participate in the amended protocol and discontinued study treatment after 12 months of study drug administration.
1156448|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
1155398|NCT00423267|O1|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg PO (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
1155399|NCT00423267|O2|Outcome|Fluconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A. Participants in this arm were given posaconazole in Period B.
1155400|NCT00423267|O1|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
1155401|NCT00423267|O1|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg PO (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
1155440|NCT00423176|B1|Baseline|Mometasone Furoate Nasal Spray (MFNS)|Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).
1155402|NCT00423267|O1|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg PO (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
1155403|NCT00423267|O2|Outcome|Fluconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A. Participants in this arm were given posaconazole in Period B.
1155404|NCT00423267|O1|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
1155405|NCT00423267|O1|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg PO (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
1155406|NCT00423267|O2|Outcome|Fluconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A. Participants in this arm were given posaconazole in Period B.
1155407|NCT00423267|O1|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
1155408|NCT00423267|O2|Outcome|Fluconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A. Participants in this arm were given posaconazole in Period B.
1155409|NCT00423267|O1|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
1155410|NCT00423267|E3|Reported Event|Posaconazole Period B|
1155411|NCT00423267|E2|Reported Event|Fluconazole Period A|
1155412|NCT00423267|E1|Reported Event|Posaconazole Period A|
1155413|NCT00423189|B4|Baseline|Total|Total of all reporting groups
1155414|NCT00423189|B3|Baseline|Arm 3|20% fluence photodynamic therapy - procedure
1155415|NCT00423189|B2|Baseline|Arm 2|40% fluence photodynamic therapy - procedure
1155416|NCT00423189|B1|Baseline|Arm 1|drug - intravitreal ranibizumab
1155417|NCT00423189|P3|Participant Flow|Ranibizumab and 20% Fluence PDT(Procedure)|20% fluence photodynamic therapy - procedure
1155418|NCT00423189|P2|Participant Flow|Ranibizumab and 40% Fluence PDT(Procedure)|40% fluence photodynamic therapy - procedure
1155419|NCT00423189|P1|Participant Flow|Ranibizumab Only|drug - intravitreal ranibizumab
1155420|NCT00423189|O3|Outcome|20% Fluence Photodynamic Therapy Combined With Ranibizumab|20% fluence photodynamic therapy combined with ranibizumab - procedure
1155421|NCT00423189|O2|Outcome|40% Fluence Photodynamic Therapy Combined With Ranibizumab|40% fluence photodynamic therapy/combined with ranibizumab - procedure
1155422|NCT00423189|O1|Outcome|Ranibizumab Only|drug - intravitreal ranibizumab
1155423|NCT00423189|O3|Outcome|20% Fluence Photodynamic Therapy Combined With Ranibizumab|20% fluence photodynamic therapy combined with ranibizumab- procedure
1155424|NCT00423189|O2|Outcome|40% Fluence Photodynamic Therapy Combined With Ranibizumab|40% fluence photodynamic therapy combined with ranibizumab- procedure
1155425|NCT00423189|O1|Outcome|Ranibizumab Only|drug - intravitreal ranibizumab
1155426|NCT00423189|O3|Outcome|20% Fluence Photodynamic Therapy Combined With Ranibizumab|20% fluence photodynamic therapy combined with ranibizumab- procedure
1155427|NCT00423189|O2|Outcome|40% Fluence Photodynamic Therapy Combined With Ranibizumab|40% fluence photodynamic therapy combined with ranibizumab- procedure
1155428|NCT00423189|O1|Outcome|Ranibizumab Only|drug - intravitreal ranibizumab
1155429|NCT00423189|O3|Outcome|20% Fluence Photodynamic Therapy Combined With Ranibizumab|20% fluence photodynamic therapy combined with ranibizumab- procedure
1155430|NCT00423189|O2|Outcome|40% Fluence Photodynamic Therapy Combined With Ranibizumab|40% fluence photodynamic therapy combined with ranibizumab- procedure
1155431|NCT00423189|O1|Outcome|Ranibizumab Only|drug - intravitreal ranibizumab
1155432|NCT00423189|O3|Outcome|20% Fluence PDT/Ranibizumab|20% Fluence PDT with IVT Ranibizumab
1155433|NCT00423189|O2|Outcome|40% Fluence PDT/Ranibizumab|40% Fluence PDT WITH ivt Ranibizumab
1155434|NCT00423189|O1|Outcome|Ranibizumab Only|IVT Ranibizumab only
1155435|NCT00423189|E3|Reported Event|20% PDT Fluence Combined With Ranibizumab|Subjects who received 20% with as needed ranibizumab
1155436|NCT00423189|E2|Reported Event|40% Fluence PDT Combined With Ranibizumab|Subjects who have received 40% fluence PDT combined with as needed dosing with ranibizumab
1155437|NCT00423189|E1|Reported Event|Ranibizumab Only|subject only received ranibizumab
1155438|NCT00423176|B3|Baseline|Total|Total of all reporting groups
1155439|NCT00423176|B2|Baseline|Placebo|Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
1155639|NCT00421733|O3|Outcome|Placebo|Two placebo capsules per dose
1155640|NCT00421733|O2|Outcome|Paricalcitol 2 Mcg|Two paricalcitol 1 mcg capsules per dose
1155441|NCT00423176|P2|Participant Flow|Placebo|Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
1155442|NCT00423176|P1|Participant Flow|Mometasone Furoate Nasal Spray (MFNS)|Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).
1155443|NCT00423176|O2|Outcome|Placebo|Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
1155444|NCT00423176|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).
1155445|NCT00423176|O2|Outcome|Placebo|Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
1155446|NCT00423176|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).
1155447|NCT00423176|E2|Reported Event|Placebo|Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
1155448|NCT00423176|E1|Reported Event|Mometasone Furoate Nasal Spray (MFNS)|Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).
1155449|NCT00423150|B1|Baseline|Temozolomide|Temozolomide capsules 150 mg/m^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.
1155450|NCT00423150|P1|Participant Flow|Temozolomide|Temozolomide capsules 150 mg/m^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.
1155451|NCT00423150|O1|Outcome|Temozolomide|Temozolomide capsules 150 mg/m^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.
1155452|NCT00423150|E1|Reported Event|Temozolomide|Temozolomide capsules 150 mg/m^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.
1155453|NCT00423098|B3|Baseline|Total|Total of all reporting groups
1155454|NCT00423098|B2|Baseline|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
1155455|NCT00423098|B1|Baseline|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
1155456|NCT00423098|P2|Participant Flow|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
1155521|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155693|NCT00422695|E2|Reported Event|Healthy Controls|HIV -free subjects 38 Healthy Controls
1155457|NCT00423098|P1|Participant Flow|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
1155458|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
1155459|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
1155460|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
1155532|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155461|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
1155462|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
1155463|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
1155464|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
1155465|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
1155466|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
1155467|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
1155468|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
1155469|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
1155522|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155694|NCT00422695|E1|Reported Event|HIV +|Groups divided according to CD4 counts 105 HIV subjects
1155470|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
1155471|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
1155472|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
1155473|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
1155474|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
1155641|NCT00421733|O1|Outcome|Paricalcitol 1 Mcg|One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
1155475|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
1155476|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
1155477|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
1155478|NCT00423098|E2|Reported Event|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
1155479|NCT00423098|E1|Reported Event|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
1155480|NCT00423085|B4|Baseline|Total|Total of all reporting groups
1155481|NCT00423085|B3|Baseline|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
1155482|NCT00423085|B2|Baseline|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
1155483|NCT00423085|B1|Baseline|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
1155484|NCT00423085|P4|Participant Flow|Open-label Extension|"All participants started treatment with daily rivastigmine 2.5 cm^2 patch. The dose was increased to 5, 7.5, and 10 cm^2 after 4 weeks of treatment at each dose level. One patch was applied once daily. The dose level reached by each individual patient at the end of this 16 weeks was maintained for the rest of the study duration (Maintenance Period). A predetermined allowed adjustment scheme was followed in patients who required dose adjustment due to low tolerability."
1155523|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155485|NCT00423085|P3|Participant Flow|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
1155486|NCT00423085|P2|Participant Flow|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
1155487|NCT00423085|P1|Participant Flow|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
1155488|NCT00423085|O1|Outcome|Open-label Extension Arm|"All participants started treatment with a daily rivastigmine 2.5 cm^2 patch. The dose was increased to 5, 7.5, and then 10 cm^2 after 4 weeks of treatment at each dose level. One patch was applied once daily. The dose level reached by each individual patient at the end of this 16 weeks was maintained for the rest of the study duration (Maintenance Period) for a total of 52 weeks. A predetermined allowed adjustment scheme was followed in participants who required dose adjustment due to low tolerability."
1155489|NCT00423085|O1|Outcome|Open-label Extension Arm|"All participants started treatment with a daily rivastigmine 2.5 cm^2 patch. The dose was increased to 5, 7.5, and then 10 cm^2 after 4 weeks of treatment at each dose level. One patch was applied once daily. The dose level reached by each individual patient at the end of this 16 weeks was maintained for the rest of the study duration (Maintenance Period) for a total of 52 weeks. A predetermined allowed adjustment scheme was followed in participants who required dose adjustment due to low tolerability."
1155490|NCT00423085|O1|Outcome|Open-label Extension Arm|"All participants started treatment with a daily rivastigmine 2.5 cm^2 patch. The dose was increased to 5, 7.5, and then 10 cm^2 after 4 weeks of treatment at each dose level. One patch was applied once daily. The dose level reached by each individual patient at the end of this 16 weeks was maintained for the rest of the study duration (Maintenance Period) for a total of 52 weeks. A predetermined allowed adjustment scheme was followed in participants who required dose adjustment due to low tolerability."
1155642|NCT00421733|O4|Outcome|Paricalcitol 2 Mcg|Two paricalcitol 1 mcg capsules per dose
1163363|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
1155491|NCT00423085|O3|Outcome|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
1155492|NCT00423085|O2|Outcome|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
1155493|NCT00423085|O1|Outcome|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
1155494|NCT00423085|O3|Outcome|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
1155495|NCT00423085|O2|Outcome|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
1155496|NCT00423085|O1|Outcome|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
1155497|NCT00423085|O3|Outcome|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
1155498|NCT00423085|O2|Outcome|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
1155499|NCT00423085|O1|Outcome|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
1155500|NCT00423085|O3|Outcome|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
1155524|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155501|NCT00423085|O2|Outcome|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
1155502|NCT00423085|O1|Outcome|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
1155503|NCT00423085|O3|Outcome|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
1155504|NCT00423085|O2|Outcome|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
1155505|NCT00423085|O1|Outcome|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
1155506|NCT00423085|O3|Outcome|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
1155507|NCT00423085|O2|Outcome|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
1155508|NCT00423085|O1|Outcome|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
1155533|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155509|NCT00423085|E4|Reported Event|Open-Label Extension (52 Weeks)|"All participants started treatment with daily rivastigmine 2.5 cm^2 patch. The dose was increased to 5, 7.5, and 10 cm^2 after 4 weeks of treatment at each dose level. One patch was applied once daily. The dose level reached by each individual patient at the end of this 16 weeks was maintained for the rest of the study duration (Maintenance Period). A predetermined allowed adjustment scheme was followed in patients who required dose adjustment due to low tolerability."
1155510|NCT00423085|E3|Reported Event|Rivastigmine 10 cm^2 (24 Weeks)|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 patch for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
1155511|NCT00423085|E2|Reported Event|Rivastigmine 5 cm^2 (24 Weeks)|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and thereafter daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
1155512|NCT00423085|E1|Reported Event|Placebo (24 Weeks)|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
1155513|NCT00423046|B3|Baseline|Total|Total of all reporting groups
1155514|NCT00423046|B2|Baseline|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155515|NCT00423046|B1|Baseline|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155516|NCT00423046|P2|Participant Flow|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155517|NCT00423046|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155518|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155519|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155520|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155695|NCT00422669|B4|Baseline|Total|Total of all reporting groups
1156449|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
1155525|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155526|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155527|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155528|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155529|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155530|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155531|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155631|NCT00421733|P2|Participant Flow|Paricalcitol 2 Mcg|Two paricalcitol 1 mcg capsules per dose
1155632|NCT00421733|P1|Participant Flow|Paricalcitol 1 Mcg|One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
1155534|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155535|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155536|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155537|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155538|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155539|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155540|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155541|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155542|NCT00423046|O2|Outcome|Gardasil Group|Gardasil Group Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155543|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155544|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155545|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155546|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155547|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155548|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155549|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155550|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155551|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155552|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155553|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155554|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155555|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155556|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155557|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155558|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155559|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155560|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155561|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155562|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155563|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155564|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155565|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155566|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155567|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155568|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155569|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155570|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155571|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155572|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155573|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155574|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155575|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155576|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155577|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155578|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155579|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155580|NCT00423046|E2|Reported Event|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155581|NCT00423046|E1|Reported Event|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
1155582|NCT00422942|B1|Baseline|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
1155633|NCT00421733|O3|Outcome|Placebo|Two placebo capsules per dose
1155583|NCT00422942|P1|Participant Flow|Rituximab + Methotrexate (MTX)|Participants received rituximab 1000 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or as needed (PRN) if retreatment criteria were not met; premedication with methylprednisolone (MP) 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg per week (mg/week; oral or parenteral) for up to 48 weeks and folate (greater than or equal to [≥]5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
1155584|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
1155585|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
1155586|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
1155587|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
1155588|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
1155589|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
1155590|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
1155591|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
1155616|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
1156450|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
1155592|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
1155593|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
1155594|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
1155595|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
1155596|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
1155634|NCT00421733|O2|Outcome|Paricalcitol 2 Mcg|Two paricalcitol 1 mcg capsules per dose
1156297|NCT00421954|E1|Reported Event|Ziprasidone|Ziprasidone: subjects will use ziprasidone
1155597|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
1155598|NCT00422942|E1|Reported Event|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
1155599|NCT00422903|B3|Baseline|Total|Total of all reporting groups
1155600|NCT00422903|B2|Baseline|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery
1155601|NCT00422903|B1|Baseline|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
1155602|NCT00422903|P2|Participant Flow|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
1155603|NCT00422903|P1|Participant Flow|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
1155604|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
1155605|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
1155606|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
1155607|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
1155608|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
1155609|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
1155610|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
1155611|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
1155612|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
1155613|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
1155614|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
1155615|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
1155617|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
1155618|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
1155619|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
1155620|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
1155621|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
1155622|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
1155623|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
1155624|NCT00422903|E2|Reported Event|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
1155625|NCT00422903|E1|Reported Event|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
1155626|NCT00421733|B4|Baseline|Total|Total of all reporting groups
1155627|NCT00421733|B3|Baseline|Placebo|Two placebo capsules per dose
1155628|NCT00421733|B2|Baseline|Paricalcitol 2 Mcg|Two paricalcitol 1 mcg capsules per dose
1155629|NCT00421733|B1|Baseline|Paricalcitol 1 Mcg|One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
1155630|NCT00421733|P3|Participant Flow|Placebo|Two placebo capsules per dose
1155643|NCT00421733|O3|Outcome|Paricalcitol 1 Mcg|One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
1155644|NCT00421733|O2|Outcome|Combined Paricalcitol 1 Mcg and 2 Mcg|Combined participants in the 1 mcg and 2 mcg paricalcitol groups (N=92+92=184).
1155645|NCT00421733|O1|Outcome|Placebo|Two placebo capsules per dose (N=88)
1155646|NCT00421733|E3|Reported Event|Placebo|Two placebo capsules per dose
1155647|NCT00421733|E2|Reported Event|Paricalcitol 2 Mcg|Two paricalcitol 1 mcg capsules per dose
1155648|NCT00421733|E1|Reported Event|Paricalcitol 1 Mcg|One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
1155649|NCT00422734|B3|Baseline|Total|Total of all reporting groups
1155650|NCT00422734|B2|Baseline|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
1155651|NCT00422734|B1|Baseline|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
1155652|NCT00422734|P2|Participant Flow|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
1155653|NCT00422734|P1|Participant Flow|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
1155654|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
1155655|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
1155656|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
1155657|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
1155658|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
1155659|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
1155660|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
1155661|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
1155662|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
1155663|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
1155664|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
1155665|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
1155666|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
1155667|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
1155668|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
1155669|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
1155670|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
1155671|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
1155672|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
1155673|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
1155674|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
1155675|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
1155676|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
1155677|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
1155678|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
1155679|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
1155680|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
1155681|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
1155682|NCT00422734|E2|Reported Event|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
1155683|NCT00422734|E1|Reported Event|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
1155684|NCT00422695|B3|Baseline|Total|Total of all reporting groups
1155696|NCT00422669|B3|Baseline|Not Randomized|7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
1155697|NCT00422669|B2|Baseline|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
1155698|NCT00422669|B1|Baseline|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
1155699|NCT00422669|P3|Participant Flow|Not Randomized|7 of the 205 subjects did not meet inclusion/exclusion criteria.
1155700|NCT00422669|P2|Participant Flow|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
1155701|NCT00422669|P1|Participant Flow|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
1155702|NCT00422669|O3|Outcome|Not Randomized|7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
1155703|NCT00422669|O2|Outcome|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
1155704|NCT00422669|O1|Outcome|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
1155705|NCT00422669|O3|Outcome|Not Randomized|7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
1155706|NCT00422669|O2|Outcome|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
1155707|NCT00422669|O1|Outcome|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
1155708|NCT00422669|O3|Outcome|Not Randomized|7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
1155709|NCT00422669|O2|Outcome|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
1155710|NCT00422669|O1|Outcome|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
1155711|NCT00422669|O3|Outcome|Not Randomized|7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
1155712|NCT00422669|O2|Outcome|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
1155713|NCT00422669|O1|Outcome|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
1155714|NCT00422669|O3|Outcome|Not Randomized|7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
1155715|NCT00422669|O2|Outcome|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
1155716|NCT00422669|O1|Outcome|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
1155717|NCT00422669|O3|Outcome|Not Randomized|7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
1155718|NCT00422669|O2|Outcome|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
1155719|NCT00422669|O1|Outcome|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
1155720|NCT00422669|E1|Reported Event|Subjects With Implant|All 198 subjects with implant were included in this group.
1155721|NCT00422656|B1|Baseline|Perifosine|This is a one armed study, all participants receive daily perifosine at 150mg orally.
1155722|NCT00422656|P1|Participant Flow|Perifosine|This is a one armed study, all participants receive daily perifosine at 150mg orally.
1155723|NCT00422656|O1|Outcome|Perifosine Single Arm Study|Daily perifosine at 150mg orally
1155724|NCT00422656|E1|Reported Event|Perifosine|This is a one armed study, all participants receive daily perifosine at 150mg orally.
1155725|NCT00422513|B3|Baseline|Total|Total of all reporting groups
1155726|NCT00422513|B2|Baseline|Epoetin Alfa|As prescribed, (iv), 3 times weekly
1155727|NCT00422513|B1|Baseline|Methoxy Polyethylene Glycol-epoetin Beta|120-360 micrograms (iv) monthly, starting dose
1155728|NCT00422513|P2|Participant Flow|Epoetin Alfa|As prescribed, (iv), 3 times weekly
1155729|NCT00422513|P1|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta|120-360 micrograms intravenous (iv) monthly, starting dose
1155730|NCT00422513|O2|Outcome|Epoetin Alfa|As prescribed, (iv), 3 times weekly
1155731|NCT00422513|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|120-360 micrograms (iv) monthly, starting dose
1155732|NCT00422513|O2|Outcome|Epoetin Alfa|As prescribed, (iv), 3 times weekly
1155733|NCT00422513|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|120-360 micrograms (iv) monthly, starting dose
1155734|NCT00422513|O2|Outcome|Epoetin Alfa|As prescribed, (iv), 3 times weekly
1155735|NCT00422513|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|120-360 micrograms (iv) monthly, starting dose
1155736|NCT00422513|O2|Outcome|Epoetin Alfa|As prescribed, (iv), 3 times weekly
1155737|NCT00422513|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|120-360 micrograms (iv) monthly, starting dose
1155738|NCT00422513|E2|Reported Event|Epoetin Alfa|As prescribed, (iv), 3 times weekly
1155739|NCT00422513|E1|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta|120-360 micrograms (iv) monthly, starting dose
1155740|NCT00422448|B1|Baseline|Nevi|with or without BRAF and NRAS
1155741|NCT00422448|P1|Participant Flow|Nevi|with or without BRAF and NRAS
1155742|NCT00422448|O1|Outcome|Nevi|with or without BRAF and NRAS
1155743|NCT00422448|O1|Outcome|Nevi|with or without BRAF and NRAS
1155744|NCT00422448|E1|Reported Event|Nevi|with or without BRAF and NRAS
1155745|NCT00422422|B1|Baseline|Brivaracetam (ES)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
1155746|NCT00422422|P1|Participant Flow|Brivaracetam (ES)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
1155747|NCT00422422|O1|Outcome|Brivaracetam (SS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
1155930|NCT00422292|O4|Outcome|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
1155748|NCT00422422|O1|Outcome|Brivaracetam (FAS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
1155749|NCT00422422|O1|Outcome|Brivaracetam (SS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
1155750|NCT00422422|O1|Outcome|Brivaracetam (PPS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
1155751|NCT00422422|O1|Outcome|Brivaracetam (PPS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
1155752|NCT00422422|O1|Outcome|Brivaracetam (PPS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
1155753|NCT00422422|O1|Outcome|Brivaracetam (PPS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
1155754|NCT00422422|O1|Outcome|Brivaracetam (PPS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
1155755|NCT00422422|O1|Outcome|Brivaracetam (PPS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
1155756|NCT00422422|E1|Reported Event|Brivaracetam (SS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
1155757|NCT00422383|B6|Baseline|Total|Total of all reporting groups
1155758|NCT00422383|B5|Baseline|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
1155915|NCT00422292|O3|Outcome|Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
1155994|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
1155759|NCT00422383|B4|Baseline|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
1155760|NCT00422383|B3|Baseline|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155931|NCT00422292|O3|Outcome|Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
1156010|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
1155761|NCT00422383|B2|Baseline|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155762|NCT00422383|B1|Baseline|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155763|NCT00422383|P5|Participant Flow|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
1155764|NCT00422383|P4|Participant Flow|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
1155765|NCT00422383|P3|Participant Flow|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155766|NCT00422383|P2|Participant Flow|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155767|NCT00422383|P1|Participant Flow|Rituximab Low Dose Plus (+) Methotrexate|Participants received rituximab, 0.5 grams (g), intravenously (IV), on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 milligrams (mg), IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 milligrams per milliliter (mg/mL), orally (PO) or parenterally, as prescribed. Participants also received a stable dose of folate greater than or equal to (≥) 5 milligrams per week (mg/week) given either as a single dose or as a divided weekly dose.
1155768|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parentally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
1155916|NCT00422292|O2|Outcome|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
1155917|NCT00422292|O1|Outcome|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
1155769|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parentally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
1155770|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parentally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155771|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parentally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155932|NCT00422292|O2|Outcome|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
1155772|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parentally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155773|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
1155774|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
1155775|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155776|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155777|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155778|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
1155779|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
1155780|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155781|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155782|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155933|NCT00422292|O1|Outcome|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
1155934|NCT00422292|E4|Reported Event|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
1155783|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155784|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155785|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155786|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155787|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155788|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155789|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155790|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155791|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155792|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155793|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155794|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155935|NCT00422292|E3|Reported Event|Group 3: Menactra® at 12 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
1156011|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
1156298|NCT00421928|B4|Baseline|Total|Total of all reporting groups
1155795|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155796|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155797|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155798|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155799|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155800|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155801|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
1155802|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
1155918|NCT00422292|O4|Outcome|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
1155803|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155804|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155805|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155806|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
1155807|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
1155808|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155809|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155810|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155811|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155812|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155813|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155814|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
1155815|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
1155816|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155817|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155818|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155819|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155820|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155821|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155822|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155823|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155824|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155825|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155826|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155919|NCT00422292|O3|Outcome|Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
1156451|NCT00421174|E2|Reported Event|Placebo|Placebo plus Corticosteroids
1155827|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155828|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155829|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155830|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155936|NCT00422292|E2|Reported Event|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Month|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
1155937|NCT00422292|E1|Reported Event|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
1155831|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155832|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155833|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155834|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155835|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155836|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155837|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155838|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155839|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155840|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155841|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155842|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155938|NCT00422279|B3|Baseline|Total|Total of all reporting groups
1155939|NCT00422279|B2|Baseline|Extraction Sites|bone inductive implants placed in tooth extraction sites
1155940|NCT00422279|B1|Baseline|Supralveolar Position|bone inductive implants placed in supraalveolar position
1155941|NCT00422279|P2|Participant Flow|Extraction Sites|bone inductive implants (Nobel Replace Tapered Groovy) placed in tooth extraction sockets
1155843|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155844|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155845|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155846|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155847|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155848|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155849|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155850|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155851|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155852|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155853|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155854|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155942|NCT00422279|P1|Participant Flow|Supraalveolar Position|bone inductive implants (Nobel Replace Tapered Groovy) placed in supraalveolar position
1155943|NCT00422279|O2|Outcome|Extraction Sites|bone inductive implants placed in tooth extraction sockets with a total of 2 patients with 4 implants ( two implants in each patient)
1156299|NCT00421928|B3|Baseline|Placebo|Matching Placebo twice daily (BID)
1155855|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
1155856|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
1155857|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155858|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155859|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155860|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
1155861|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
1155862|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155863|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155864|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155865|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155944|NCT00422279|O1|Outcome|Supraalveloar Postion|bone inductive implants placed in supraalveolar position a total of 2 patients with 4 implants ( two implants in each patient)
1155945|NCT00422279|O2|Outcome|Extraction Sites|bone inductive implants (Nobel Replace Tapered Groovy) placed in tooth extraction sockets
1163364|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1155866|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155867|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155868|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155869|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155870|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155871|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155872|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155873|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155874|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155875|NCT00422383|O2|Outcome|Rituximab Escalated Dose Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155876|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155877|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155946|NCT00422279|O1|Outcome|Supra Aleveolar Position|bone inductive implants (Nobel Replace Tapered Groovy) placed in supraalveolar position
1155947|NCT00422279|E2|Reported Event|Extraction Sites|bone inductive implants (Nobel Replace Tapered Groovy) placed in tooth extraction sites
1155948|NCT00422279|E1|Reported Event|Supralveolar Position|bone inductive implants (Nobel Replace Tapered Groovy) placed in supraalveolar position
1155878|NCT00422383|O2|Outcome|Rituximab Escalated Dose Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155879|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155880|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
1155881|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
1155882|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155883|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155884|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155920|NCT00422292|O2|Outcome|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
1155885|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155886|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155887|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155888|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155889|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155949|NCT00422227|B3|Baseline|Total|Total of all reporting groups
1163365|NCT00402987|O3|Outcome|Placebo|
1155890|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155891|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155892|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155893|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155894|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155895|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155896|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155921|NCT00422292|O1|Outcome|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
1155995|NCT00422162|O6|Outcome|Duloxetine 120 mg (All)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
1155897|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155898|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155899|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155900|NCT00422383|E5|Reported Event|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
1155901|NCT00422383|E4|Reported Event|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
1156008|NCT00422162|O1|Outcome|Duloxetine 60 mg Responders|60mg QD for 8 weeks
1155902|NCT00422383|E3|Reported Event|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155903|NCT00422383|E2|Reported Event|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155904|NCT00422383|E1|Reported Event|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
1155905|NCT00422292|B5|Baseline|Total|Total of all reporting groups
1155906|NCT00422292|B4|Baseline|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
1155907|NCT00422292|B3|Baseline|Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
1155908|NCT00422292|B2|Baseline|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
1155909|NCT00422292|B1|Baseline|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
1155910|NCT00422292|P4|Participant Flow|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
1155911|NCT00422292|P3|Participant Flow|Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
1155912|NCT00422292|P2|Participant Flow|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
1155913|NCT00422292|P1|Participant Flow|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
1155914|NCT00422292|O4|Outcome|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
1155993|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
1155922|NCT00422292|O4|Outcome|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
1155923|NCT00422292|O3|Outcome|Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
1155924|NCT00422292|O2|Outcome|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
1155925|NCT00422292|O1|Outcome|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
1155926|NCT00422292|O4|Outcome|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
1155927|NCT00422292|O3|Outcome|Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
1155928|NCT00422292|O2|Outcome|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
1155929|NCT00422292|O1|Outcome|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
1156300|NCT00421928|B2|Baseline|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
1155950|NCT00422227|B2|Baseline|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
1155951|NCT00422227|B1|Baseline|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
1155952|NCT00422227|P2|Participant Flow|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
1155953|NCT00422227|P1|Participant Flow|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
1155954|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
1155955|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
1155956|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
1155957|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
1155958|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
1155959|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
1155960|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
1155961|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
1155962|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
1155963|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
1155964|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
1155965|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
1155966|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
1155967|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
1155968|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
1155969|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
1155970|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
1156009|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
1155971|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
1155972|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
1155973|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
1155974|NCT00422227|E2|Reported Event|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
1155975|NCT00422227|E1|Reported Event|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
1155976|NCT00422201|B1|Baseline|Mifepristone|"Single arm. Study medication was to be administered at a total daily dose of 600 mg (given as one 200 mg tablet tid, per os) starting on the day of inclusion.~This dose was to be maintained during the whole study except in case of suspicion of adrenal insufficiency, in which case the dose was temporally stopped for 2 to 3 days and restarted at a lower dose of 400 mg daily until the end of the study."
1155977|NCT00422201|P1|Participant Flow|Single Arm Mifepristone|"Study medication was to be administered at a total daily dose of 600 mg (given as one 200 mg tablet tid, per os) starting on the day of inclusion.~This dose was to be maintained during the whole study except in case of suspicion of adrenal insufficiency, in which case the dose was temporally stopped for 2 to 3 days and restarted at a lower dose of 400 mg daily until the end of the study."
1155978|NCT00422201|O1|Outcome|Mifepristone|"Single arm. Study medication was administered at a total daily dose of 600 mg (given as one 200 mg tablet tid, per os) starting on the day of inclusion.~This dose was to be maintained during the whole study except in case of suspicion of adrenal insufficiency, in which case the dose was temporally stopped for 2 to 3 days and restarted at a lower dose of 400 mg daily until the end of the study."
1155979|NCT00422201|E1|Reported Event|Mifepristone|"Single arm. Study medication was to be administered at a total daily dose of 600 mg (given as one 200 mg tablet tid, per os) starting on the day of inclusion.~This dose was to be maintained during the whole study except in case of suspicion of adrenal insufficiency, in which case the dose was temporally stopped for 2 to 3 days and restarted at a lower dose of 400 mg daily until the end of the study."
1155980|NCT00422162|B3|Baseline|Total|Total of all reporting groups
1155981|NCT00422162|B2|Baseline|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
1155982|NCT00422162|B1|Baseline|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
1155983|NCT00422162|P2|Participant Flow|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
1155984|NCT00422162|P1|Participant Flow|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
1155985|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
1155986|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
1155987|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
1155988|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
1155989|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
1155990|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
1155991|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
1155992|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
1155996|NCT00422162|O5|Outcome|Duloxetine 60 mg (All)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
1155997|NCT00422162|O4|Outcome|Duloxetine 120 mg Non-Responder|60mg BID for 8 weeks (placebo added at Week 4)
1155998|NCT00422162|O3|Outcome|Duloxetine 120 mg Responder|60mg BID for 8 weeks
1155999|NCT00422162|O2|Outcome|Duloxetine 60 mg Non-Responder|60mg QD for 4 weeks then 60mg BID for 4 weeks
1156000|NCT00422162|O1|Outcome|Duloxetine 60 mg Responder|60mg QD for 8 weeks
1156001|NCT00422162|O4|Outcome|Duloxetine 120 mg Non-Responders|60mg BID for 8 weeks (placebo added at Week 4)
1156002|NCT00422162|O3|Outcome|Duloxetine 120 mg Responders|60mg BID for 8 weeks
1156003|NCT00422162|O2|Outcome|Duloxetine 60 mg Non-Responders|60mg QD for 4 weeks then 60mg BID for 4 weeks
1156004|NCT00422162|O1|Outcome|Duloxetine 60 mg Responders|60mg QD for 8 weeks
1156005|NCT00422162|O4|Outcome|Duloxetine 120 mg Non-Responders|60mg BID for 8 weeks (placebo added at Week 4)
1156006|NCT00422162|O3|Outcome|Duloxetine 120 mg Responders|60mg BID for 8 weeks
1156007|NCT00422162|O2|Outcome|Duloxetine 60 mg Non-Responders|60mg QD for 4 weeks then 60mg BID for 4 weeks
1156012|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
1156013|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
1156014|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
1156015|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
1156016|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
1156017|NCT00422162|O4|Outcome|Duloxetine 120 mg Non-Responder|60mg BID for 8 weeks (placebo added at Week 4)
1156018|NCT00422162|O3|Outcome|Duloxetine 120 mg Responder|60mg BID for 8 weeks
1156019|NCT00422162|O2|Outcome|Duloxetine 60 mg Non-Responder|60mg QD for 4 weeks then 60mg BID for 4 weeks
1156020|NCT00422162|O1|Outcome|Duloxetine 60 mg Responder|60mg QD for 8 weeks
1156021|NCT00422162|O6|Outcome|Duloxetine 120 mg (All)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
1156022|NCT00422162|O5|Outcome|Duloxetine 60 mg (All)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
1156023|NCT00422162|O4|Outcome|Duloxetine 120 mg Non-Responder|60mg BID for 8 weeks (placebo added at Week 4)
1156024|NCT00422162|O3|Outcome|Duloxetine 120 mg Responder|60mg BID for 8 weeks
1156025|NCT00422162|O2|Outcome|Duloxetine 60 mg Non-Responder|60mg QD for 4 weeks then 60mg BID for 4 weeks
1156026|NCT00422162|O1|Outcome|Duloxetine 60 mg Responder|60mg QD for 8 weeks
1156027|NCT00422162|O6|Outcome|Duloxetine 120 mg (All)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
1156028|NCT00422162|O5|Outcome|Duloxetine 60 mg (All)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
1156029|NCT00422162|O4|Outcome|Duloxetine 120 mg Non-Responder|60mg BID for 8 weeks (placebo added at Week 4)
1156030|NCT00422162|O3|Outcome|Duloxetine 120 mg Responder|60mg BID for 8 weeks
1156031|NCT00422162|O2|Outcome|Duloxetine 60 mg Non-Responder|60mg QD for 4 weeks then 60mg BID for 4 weeks
1156032|NCT00422162|O1|Outcome|Duloxetine 60 mg Responder|60mg QD for 8 weeks
1156033|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
1156034|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
1156035|NCT00422162|E2|Reported Event|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
1156036|NCT00422162|E1|Reported Event|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
1156037|NCT00422097|B7|Baseline|Total|Total of all reporting groups
1156038|NCT00422097|B6|Baseline|Ixabepilone, 30 mg/d|Participants with advanced cancer received daily oral doses of ixabepilone, 30 mg, on Days 1 through 5 every 21 days.
1156039|NCT00422097|B5|Baseline|Ixabepilone, 25 mg/d|Participants with advanced cancer received daily oral doses of ixabepilone, 25 mg, on Days 1 through 5 every 21 days.
1156040|NCT00422097|B4|Baseline|Ixabepilone, 20 mg/d|Participants with advanced cancer received daily oral doses of ixabepilone, 20 mg, on Days 1 through 5 every 21 days.
1156041|NCT00422097|B3|Baseline|Ixabepilone, 15 mg/d|Participants with advanced cancer received daily oral doses of ixabepilone, 15 mg, on Days 1 through 5 every 21 days.
1156042|NCT00422097|B2|Baseline|Ixabepilone, 10 mg/d|Participants with advanced cancer received daily oral doses of ixabepilone, 10 mg, on Days 1 through 5 every 21 days.
1156043|NCT00422097|B1|Baseline|Ixabepilone, 5 mg/d|Participants with advanced cancer received daily oral doses of ixabepilone, 5 mg, on Days 1 through 5 every 21 days.
1156044|NCT00422097|P8|Participant Flow|Ixabepilone, MTD (25 mg), With Food|Cohort opened for Cycle 2, after ixabepilone MTD (25 mg) determined. In Cycle 1, participants received ixabepilone, 25 mg, once daily in an oral dose on Days 1 through 5. On all dosing days in Cycle 1, participants fasted at least 4 hours before and 4 hours after dosing. Then participants crossed over to Cycle 2. On Day 1 of Cycle 2, participants allowed a low-fat meal. Participants ingest the specified meal within a 30-minute period and receive ixabepilone, 25 mg, 30 minutes after start of the meal. For the duration of Cycle 2, participants fast 1 hour before and 2 hours after ixabepilone dose.
1156045|NCT00422097|P7|Participant Flow|Ixabepilone, MTD (25 mg), With Famotidine|Cohort opened for Cycle 2, once ixabepilone MTD (25 mg) determined. In Cycle 1, participants received ixabepilone, 25 mg, alone, orally once per day on Days 1 through 21. Then participants crossed over to receive famotidine wirh ixabepilone in Cycle 2. Prior to dosing on Day 1 of Cycle 2, famotidine, 40 mg, administered in an oral dose 2 hours before ixabepilone 25-mg dose.
1156452|NCT00421174|E1|Reported Event|Etanercept|Etanercept plus corticosteroids
1156046|NCT00422097|P6|Participant Flow|Ixabepilone, 30 mg/d|Ixabepilone, 30 mg, given daily orally on Days 1 through 5 every 21 days. If 2 or more of the first 3 participants experience a DLT within the first 21-day course, this dose level will be considered above the MTD. If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants. If 2 or more of the 6 participants (or 1/3 or more of a cohort with more than 6 participants) experience a DLT, this dose level will be considered above the MTD (the maximum dose that can be given to 6 participants without producing a DLT in more than 1 [or fewer than 1/3 if more than 6 participants in cohort)]. On all dosing days in Cycle 1, participants to fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
1156067|NCT00422097|O4|Outcome|Ixabepilone, 20 mg/d|Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156068|NCT00422097|O3|Outcome|Ixabepilone, 15 mg/d|Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156047|NCT00422097|P5|Participant Flow|Ixabepilone, 25 mg/d|Ixabepilone, 25 mg/d, given once daily in an oral dose on Days 1 through 5 every 21 days. If none of the first 3 participants experiences a DLT in the first 21-day course, a new cohort is opened at the next dose level (30 mg/d). If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants. If 2 or more of the 6 participants (or 1/3 or more of a cohort with more than 6 participants) experience a DLT, this dose level will be considered above the MTD. The MTD is the maximum dose that can be given to 6 participants without producing a DLT in more than 1 participant (or fewer than 1/3 if the cohort has more than 6 participants). More participants may be enrolled at any level to provide additional safety data. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
1156048|NCT00422097|P4|Participant Flow|Ixabepilone, 20 mg/d|Ixabepilone, 20 mg, given daily in oral doses on Days 1 through 5 every 21 days. If none of the first 3 participants experiences a DLT during the first 21-day course, a new cohort is opened at the next dose level (25 mg/d). On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
1156049|NCT00422097|P3|Participant Flow|Ixabepilone, 15 mg/d|Ixabepilone, 15 mg, given once daily in an oral dose on Days 1 through 5 every 21 days. If none of the first 3 participants experiences a DLT during the first 21-day course, a new cohort is opened at the next dose level (20 mg/d). If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
1156050|NCT00422097|P2|Participant Flow|Ixabepilone, 10 mg/d|Ixabepilone, 10 mg, given once daily in an oral dose on Days 1 through 5 every 21 days. If none of the first 3 participants experiences a DLT during the first 21-day course, a new cohort is opened at the next dose level (15 mg/d). If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
1156051|NCT00422097|P1|Participant Flow|Ixabepilone, 5 mg/d|Ixabepilone, 5 mg, given once daily in an oral dose on Days 1 through 5 every 21 days. If none of the first 3 participants experiences a dose-limiting toxicity (DLT) in the first 21-day course, a new cohort is opened at the next dose level (10 mg/d). On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
1156052|NCT00422097|O1|Outcome|All Treated Participants|Participants received daily oral doses of ixabepilone on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156053|NCT00422097|O6|Outcome|Ixabepilone, 30 mg/d|Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156054|NCT00422097|O5|Outcome|Ixabepilone, 25 mg/d|Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156055|NCT00422097|O4|Outcome|Ixabepilone, 20 mg/d|Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156056|NCT00422097|O3|Outcome|Ixabepilone, 15 mg/d|Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156057|NCT00422097|O2|Outcome|Ixabepilone, 10 mg/d|Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156058|NCT00422097|O1|Outcome|Ixabepilone, 5 mg/d|Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156087|NCT00422097|O2|Outcome|Ixabepilone, 10 mg/d|All participants who received ixabepilone and who had adequate concentration profiles were included.
1156453|NCT00420992|B3|Baseline|Total|Total of all reporting groups
1156059|NCT00422097|O1|Outcome|Ixabepilone, 25 mg/d|Participants who received MTD (25 mg) ixabepilone without famotidine and then were crossed over to a cycle in which they received MTD (25 mg) ixabepilone with famotidine. Fasted/Fed criteria: Cycle 1: Dose 1 administered after a minimum of a 4-hour fast. Cycle 2: Dose 1 administered with a low-fat meal to crossover cohort.
1156060|NCT00422097|O1|Outcome|Ixabepilone, 25 mg/d|Participants received MTD (25 mg) ixabepilone without famotidine (Cycle 1) and then were crossed over to a cycle in which they received MTD (25 mg) ixabepilone (with famotidine (Cycle 2). On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after ixabepilone treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
1156061|NCT00422097|O1|Outcome|Ixabepilone, 25 mg/d|
1156062|NCT00422097|O1|Outcome|Ixabepilone, 25 mg/d|
1156063|NCT00422097|O1|Outcome|Ixabepilone, 25 mg/d|
1156064|NCT00422097|O1|Outcome|Ixabepilone, 25 mg/d|
1156065|NCT00422097|O6|Outcome|Ixabepilone, 30 mg/d|Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156066|NCT00422097|O5|Outcome|Ixabepilone, 25 mg/d|Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156069|NCT00422097|O2|Outcome|Ixabepilone, 10 mg/d|Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156070|NCT00422097|O1|Outcome|Ixabepilone, 5 mg/d|Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156071|NCT00422097|O6|Outcome|Ixabepilone, 30 mg/d|Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156072|NCT00422097|O5|Outcome|Ixabepilone, 25 mg/d|Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156073|NCT00422097|O4|Outcome|Ixabepilone, 20 mg/d|Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156074|NCT00422097|O3|Outcome|Ixabepilone, 15 mg/d|Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156075|NCT00422097|O2|Outcome|Ixabepilone, 10 mg/d|Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156076|NCT00422097|O1|Outcome|Ixabepilone, 5 mg/d|Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156077|NCT00422097|O6|Outcome|Ixabepilone, 30 mg/d|Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156078|NCT00422097|O5|Outcome|Ixabepilone, 25 mg/d|Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156079|NCT00422097|O4|Outcome|Ixabepilone, 20 mg/d|Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156080|NCT00422097|O3|Outcome|Ixabepilone, 15 mg/d|Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156081|NCT00422097|O2|Outcome|Ixabepilone, 10 mg/d|Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156082|NCT00422097|O1|Outcome|Ixabepilone, 5 mg/d|Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156083|NCT00422097|O6|Outcome|Ixabepilone, 30 mg/d|All participants who received ixabepilone and who had adequate concentration profiles were included.
1156084|NCT00422097|O5|Outcome|Ixabepilone, 25 mg/d|All participants who received ixabepilone and who had adequate concentration profiles were included.
1156085|NCT00422097|O4|Outcome|Ixabepilone, 20 mg/d|All participants who received ixabepilone and who had adequate concentration profiles were included.
1156086|NCT00422097|O3|Outcome|Ixabepilone, 15 mg/d|All participants who received ixabepilone and who had adequate concentration profiles were included.
1156454|NCT00420992|B2|Baseline|Placebo|
1156455|NCT00420992|B1|Baseline|ALO-01|
1156088|NCT00422097|O1|Outcome|Ixabepilone, 5 mg/d|All participants who received ixabepilone and who had adequate concentration profiles were included.
1156089|NCT00422097|O6|Outcome|Ixabepilone, 30 mg/d|Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156090|NCT00422097|O5|Outcome|Ixabepilone, 25 mg/d|Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156091|NCT00422097|O4|Outcome|Ixabepilone, 20 mg/d|Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156092|NCT00422097|O3|Outcome|Ixabepilone, 15 mg/d|Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156274|NCT00421993|O4|Outcome|Gel Vehicle|Topical Gel Vehicle
1156275|NCT00421993|O3|Outcome|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
1156093|NCT00422097|O2|Outcome|Ixabepilone, 10 mg/d|Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156094|NCT00422097|O1|Outcome|Ixabepilone, 5 mg/d|Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156095|NCT00422097|O1|Outcome|All Treated Participants|Participants received daily oral doses of ixabepilone on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156096|NCT00422097|O1|Outcome|All Treated Participants|Participants received daily oral doses of ixabepilone on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156097|NCT00422097|O6|Outcome|Ixabepilone, 30 mg/d|Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156098|NCT00422097|O5|Outcome|Ixabepilone, 25 mg/d|Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156099|NCT00422097|O4|Outcome|Ixabepilone, 20 mg/d|Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156100|NCT00422097|O3|Outcome|Ixabepilone, 15 mg/d|Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156101|NCT00422097|O2|Outcome|Ixabepilone, 10 mg/d|Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156102|NCT00422097|O1|Outcome|Ixabepilone, 5 mg/d|Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
1156103|NCT00422097|E6|Reported Event|Ixabepilone, 30 mg|Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days
1156104|NCT00422097|E5|Reported Event|Ixabepilone, 25 mg|Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days
1156105|NCT00422097|E4|Reported Event|Ixabepilone, 20 mg|Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days
1156106|NCT00422097|E3|Reported Event|Ixabepilone, 15 mg|Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days
1156107|NCT00422097|E2|Reported Event|Ixabepilone, 10 mg|Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days
1156108|NCT00422097|E1|Reported Event|Ixabepilone, 5 mg|Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days
1156109|NCT00422058|B7|Baseline|Total|Total of all reporting groups
1156110|NCT00422058|B6|Baseline|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
1156111|NCT00422058|B5|Baseline|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156112|NCT00422058|B4|Baseline|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156254|NCT00422032|O1|Outcome|15 mg/m^2 Clofarabine|Lower Dose Clofarabine Group A: 15 mg/m^2 intravenous (IV) over 1 hour daily for 5 days
1156255|NCT00422032|E2|Reported Event|30 mg/m^2 Clofarabine|Higher Dose Clofarabine Group B: 30 mg/m^2 IV over 1 hour daily for 5 days
1156113|NCT00422058|B3|Baseline|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156114|NCT00422058|B2|Baseline|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156115|NCT00422058|B1|Baseline|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156116|NCT00422058|P6|Participant Flow|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
1156117|NCT00422058|P5|Participant Flow|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156118|NCT00422058|P4|Participant Flow|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156276|NCT00421993|O2|Outcome|Adapalene Gel|Adapalene Topical Gel
1156119|NCT00422058|P3|Participant Flow|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156120|NCT00422058|P2|Participant Flow|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156121|NCT00422058|P1|Participant Flow|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156122|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
1156123|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156124|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156125|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156126|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156127|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156128|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
1156129|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156130|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156131|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156132|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156133|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156134|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
1156135|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156136|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156137|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156138|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156139|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156140|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
1156141|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156277|NCT00421993|O1|Outcome|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
1156142|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156143|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156144|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156145|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156146|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
1156147|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156148|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156149|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156150|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156151|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156152|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
1156153|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156154|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156155|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156156|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156157|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156158|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
1156159|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156160|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156161|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156162|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156163|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156164|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
1156278|NCT00421993|O4|Outcome|Gel Vehicle|Topical Gel Vehicle
1163366|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
1156165|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156166|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156167|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156168|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156169|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156170|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
1156171|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156172|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156173|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156174|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156175|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156176|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
1156177|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156178|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156179|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156180|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156204|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156181|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156182|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
1156183|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156184|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156185|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156186|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156187|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156279|NCT00421993|O3|Outcome|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
1156188|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
1156189|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156190|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156191|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156192|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156193|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156194|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
1156195|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156196|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156197|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156198|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156199|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156200|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
1156201|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156202|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156203|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156205|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156206|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
1156207|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156208|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156209|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156210|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156280|NCT00421993|O2|Outcome|Adapalene Gel|Adapalene Topical Gel
1163367|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1156211|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156212|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
1156213|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156214|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156215|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156216|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156217|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156218|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
1156219|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156220|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156221|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156222|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156223|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156224|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
1156225|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156226|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156227|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156228|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156229|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156230|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
1156231|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156232|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156233|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156281|NCT00421993|O1|Outcome|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
1156234|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156235|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156236|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
1156237|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156238|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156239|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156240|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156241|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156242|NCT00422058|E6|Reported Event|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
1156243|NCT00422058|E5|Reported Event|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156244|NCT00422058|E4|Reported Event|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156245|NCT00422058|E3|Reported Event|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156246|NCT00422058|E2|Reported Event|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156247|NCT00422058|E1|Reported Event|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
1156248|NCT00422032|B3|Baseline|Total|Total of all reporting groups
1156249|NCT00422032|B2|Baseline|30 mg/m^2 Clofarabine|Higher Dose Clofarabine Group B: 30 mg/m^2 IV over 1 hour daily for 5 days
1156250|NCT00422032|B1|Baseline|15 mg/m^2 Clofarabine|Lower Dose Clofarabine Group A: 15 mg/m^2 intravenous (IV) over 1 hour daily for 5 days
1156251|NCT00422032|P2|Participant Flow|30 mg/m^2 Clofarabine|Higher Dose Clofarabine Group B: 30 mg/m^2 IV over 1 hour daily for 5 days
1156252|NCT00422032|P1|Participant Flow|15 mg/m^2 Clofarabine|Lower Dose Clofarabine Group A: 15 mg/m^2 intravenous (IV) over 1 hour daily for 5 days
1156253|NCT00422032|O2|Outcome|30 mg/m^2 Clofarabine|Higher Dose Clofarabine Group B: 30 mg/m^2 IV over 1 hour daily for 5 days
1156431|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
1156256|NCT00422032|E1|Reported Event|15 mg/m^2 Clofarabine|Lower Dose Clofarabine Group A: 15 mg/m^2 intravenous (IV) over 1 hour daily for 5 days
1156257|NCT00421993|B5|Baseline|Total|Total of all reporting groups
1156258|NCT00421993|B4|Baseline|Gel Vehicle|Topical Gel Vehicle
1156259|NCT00421993|B3|Baseline|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
1156260|NCT00421993|B2|Baseline|Adapalene Gel|Adapalene Topical Gel
1156261|NCT00421993|B1|Baseline|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
1156262|NCT00421993|P4|Participant Flow|Gel Vehicle|Topical Gel Vehicle
1156263|NCT00421993|P3|Participant Flow|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
1156264|NCT00421993|P2|Participant Flow|Adapalene Gel|Adapalene Topical Gel
1156265|NCT00421993|P1|Participant Flow|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
1156266|NCT00421993|O4|Outcome|Gel Vehicle|Topical Gel Vehicle
1156267|NCT00421993|O3|Outcome|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
1156268|NCT00421993|O2|Outcome|Adapalene Gel|Adapalene Topical Gel
1156269|NCT00421993|O1|Outcome|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
1156270|NCT00421993|O4|Outcome|Gel Vehicle|Topical Gel Vehicle
1156271|NCT00421993|O3|Outcome|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
1156272|NCT00421993|O2|Outcome|Adapalene Gel|Adapalene Topical Gel
1156273|NCT00421993|O1|Outcome|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
1156301|NCT00421928|B1|Baseline|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
1156302|NCT00421928|P3|Participant Flow|Placebo|Matching Placebo twice daily (BID)
1156303|NCT00421928|P2|Participant Flow|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
1156304|NCT00421928|P1|Participant Flow|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
1156305|NCT00421928|O3|Outcome|Placebo|Matching Placebo twice daily (BID)
1156306|NCT00421928|O2|Outcome|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
1156307|NCT00421928|O1|Outcome|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
1156308|NCT00421928|O3|Outcome|Placebo|Matching Placebo twice daily (BID)
1156309|NCT00421928|O2|Outcome|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
1156310|NCT00421928|O1|Outcome|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
1156311|NCT00421928|O3|Outcome|Placebo|Matching Placebo twice daily (BID)
1156312|NCT00421928|O2|Outcome|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
1156313|NCT00421928|O1|Outcome|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
1156314|NCT00421928|O3|Outcome|Placebo|Matching Placebo twice daily (BID)
1156315|NCT00421928|O2|Outcome|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
1156316|NCT00421928|O1|Outcome|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
1156317|NCT00421928|O3|Outcome|Placebo|Matching Placebo twice daily (BID)
1156318|NCT00421928|O2|Outcome|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
1156319|NCT00421928|O1|Outcome|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
1156320|NCT00421928|O3|Outcome|Placebo|Matching Placebo twice daily (BID)
1156321|NCT00421928|O2|Outcome|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
1156322|NCT00421928|O1|Outcome|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
1156323|NCT00421928|O3|Outcome|Placebo|Matching Placebo twice daily (BID)
1156324|NCT00421928|O2|Outcome|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
1156325|NCT00421928|O1|Outcome|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
1156326|NCT00421928|E3|Reported Event|Placebo|Matching Placebo twice daily (BID)
1156327|NCT00421928|E2|Reported Event|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
1156328|NCT00421928|E1|Reported Event|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
1156329|NCT00421889|B10|Baseline|Total|Total of all reporting groups
1156330|NCT00421889|B9|Baseline|Part D: Bladder Cancer MTD|PXD101: 1000 mg/m² 30-minute IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Carboplatin: AUC 5 IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m² IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3
1156331|NCT00421889|B8|Baseline|Part C: 6 Hours Infusion Solid Tumors, Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 6-hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
1156332|NCT00421889|B7|Baseline|Part C: 3 Hours Infusion, Solid Tumors Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 3 hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
1156333|NCT00421889|B6|Baseline|Part B: Ovarian Cancer MTD|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
1156334|NCT00421889|B5|Baseline|Part A: Dose Escalation 1000/5/175|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
1156335|NCT00421889|B4|Baseline|Part A: Dose Escalation 800/5/175|PXD101: 800 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
1156432|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
1156433|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
1156336|NCT00421889|B3|Baseline|Part A: Dose Escalation 600/5/175|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
1156337|NCT00421889|B2|Baseline|Part A: Dose Escalation 600/NA/175|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: None administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
1156338|NCT00421889|B1|Baseline|Part A: Dose Escalation 600/5/NA|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 0 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
1156339|NCT00421889|P9|Participant Flow|Part D: Bladder Cancer MTD|PXD101: 1000 mg/m² 30-minute IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Carboplatin: AUC 5 IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m² IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3
1156340|NCT00421889|P8|Participant Flow|Part C: 6 Hours Infusion Solid Tumors, Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 6-hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
1156398|NCT00421408|B2|Baseline|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).~Whey protein supplement : 40-g whey protein supplement daily for 18 months"
1156341|NCT00421889|P7|Participant Flow|Part C: 3 Hours Infusion, Solid Tumors Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 3 hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
1156342|NCT00421889|P6|Participant Flow|Part B: Ovarian Cancer MTD|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
1156343|NCT00421889|P5|Participant Flow|Part A: Dose Escalation 1000/5/175|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
1156344|NCT00421889|P4|Participant Flow|Part A: Dose Escalation 800/5/175|PXD101: 800 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
1156345|NCT00421889|P3|Participant Flow|Part A: Dose Escalation 600/5/175|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
1156346|NCT00421889|P2|Participant Flow|Part A: Dose Escalation 600/NA/175|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: None administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
1156347|NCT00421889|P1|Participant Flow|Part A: Dose Escalation 600/5/NA|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 (area under the curve) administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 0 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
1156348|NCT00421889|O1|Outcome|Part A|Belinostat: Dose escalating up to 1000 mg/m2 days 1-5 in a 21 day cycle; IV Paclitaxel: administered in an intravenous infusion 2-3 hours after PXD101 infusion on day 3 of a 21 day cycle Carboplatin: administered in an intravenous infusion after paclitaxel on day 3 of a 21 day cycle
1156349|NCT00421889|O5|Outcome|Belinostat 1000 mg/6-hours|Belinostat 1000 mg/m² was administered as a 6-hour IV infusion every 24 hours
1156350|NCT00421889|O4|Outcome|Belinostat 1000 mg/3-hours|Belinostat: 1000 mg/m² was administered as a 3 hour IV infusion every 24 hours
1156351|NCT00421889|O3|Outcome|Belinostat 1000 mg/30 Min|Belinostat 1000 mg/m2 30-minute IV infusion
1156352|NCT00421889|O2|Outcome|Belinostat 800 mg/30 Min|PXD101: 800 mg/m2 30-minute IV infusion
1156353|NCT00421889|O1|Outcome|Belinostat 600 mg/30 Minutes|PXD101: 600 mg/m2 30-minute IV infusion
1156354|NCT00421889|O5|Outcome|Belinostat 1000 mg/6-hours|Belinostat 1000 mg/m² was administered as a 6-hour IV infusion every 24 hours
1156355|NCT00421889|O4|Outcome|Belinostat 1000 mg/3-hours|Belinostat: 1000 mg/m² was administered as a 3 hour IV infusion every 24 hours
1156356|NCT00421889|O3|Outcome|Belinostat 1000 mg/30 Min|Belinostat 1000 mg/m2 30-minute IV infusion
1156357|NCT00421889|O2|Outcome|Belinostat 800 mg/30 Min|PXD101: 800 mg/m2 30-minute IV infusion
1156358|NCT00421889|O1|Outcome|Belinostat 600 mg/30 Minutes|PXD101: 600 mg/m2 30-minute IV infusion
1156359|NCT00421889|O5|Outcome|Belinostat 1000 mg/6-hours|Belinostat 1000 mg/m² was administered as a 6-hour IV infusion every 24 hours
1156360|NCT00421889|O4|Outcome|Belinostat 1000 mg/3-hours|Belinostat: 1000 mg/m² was administered as a 3 hour IV infusion every 24 hours
1156361|NCT00421889|O3|Outcome|Belinostat 1000 mg/30 Min|Belinostat 1000 mg/m2 30-minute IV infusion
1156362|NCT00421889|O2|Outcome|Belinostat 800 mg/30 Min|PXD101: 800 mg/m2 30-minute IV infusion
1156363|NCT00421889|O1|Outcome|Belinostat 600 mg/30 Minutes|PXD101: 600 mg/m2 30-minute IV infusion
1156364|NCT00421889|O3|Outcome|Part D: Bladder Cancer MTD|PXD101: 1000 mg/m² 30-minute IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Carboplatin: AUC 5 IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m² IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3
1156365|NCT00421889|O2|Outcome|Part C: 3-6 Hours Infusion, Solid Tumors Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 3-6 hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
1156366|NCT00421889|O1|Outcome|Part B: Ovarian Cancer MTD|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
1156367|NCT00421889|O3|Outcome|Part D: Bladder Cancer MTD|PXD101: 1000 mg/m² 30-minute IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Carboplatin: AUC 5 IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m² IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3
1156368|NCT00421889|O2|Outcome|Part C: 3-6 Hours Infusion, Solid Tumors Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 3-6 hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
1156369|NCT00421889|O1|Outcome|Part B: Ovarian Cancer MTD|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
1156370|NCT00421889|O3|Outcome|Part D: Bladder Cancer MTD|PXD101: 1000 mg/m² 30-minute IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Carboplatin: AUC 5 IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m² IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3
1156399|NCT00421408|B1|Baseline|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).~Placebo : Placebo supplement daily for 18 months"
1157175|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
1156371|NCT00421889|O2|Outcome|Part C: 3-6 Hours Infusion, Solid Tumors Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 3-6 hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
1156372|NCT00421889|O1|Outcome|Part B: Ovarian Cancer MTD|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
1156373|NCT00421889|O1|Outcome|Part A|Belinostat: Dose escalating up to 1000 mg/m2 days 1-5 in a 21 day cycle; IV Paclitaxel: administered in an intravenous infusion 2-3 hours after PXD101 infusion on day 3 of a 21 day cycle Carboplatin: administered in an intravenous infusion after paclitaxel on day 3 of a 21 day cycle
1156374|NCT00421889|O9|Outcome|Part D: Bladder Cancer MTD|PXD101: 1000 mg/m² 30-minute IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Carboplatin: AUC 5 IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m² IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3
1156375|NCT00421889|O8|Outcome|Part C: 6 Hours Infusion Solid Tumors, Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 6-hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
1156376|NCT00421889|O7|Outcome|Part C: 3 Hours Infusion, Solid Tumors Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 3 hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
1156377|NCT00421889|O6|Outcome|Part B: Ovarian Cancer MTD|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
1156378|NCT00421889|O5|Outcome|Part A: Dose Escalation 1000/5/175|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
1156379|NCT00421889|O4|Outcome|Part A: Dose Escalation 800/5/175|PXD101: 800 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
1156380|NCT00421889|O3|Outcome|Part A: Dose Escalation 600/5/175|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
1156381|NCT00421889|O2|Outcome|Part A: Dose Escalation 600/NA/175|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: None administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
1156382|NCT00421889|O1|Outcome|Part A: Dose Escalation 600/5/NA|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 0 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
1156383|NCT00421889|O1|Outcome|Part A|Belinostat: Dose escalating up to 1000 mg/m2 days 1-5 in a 21 day cycle; IV Paclitaxel: administered in an intravenous infusion 2-3 hours after PXD101 infusion on day 3 of a 21 day cycle Carboplatin: administered in an intravenous infusion after paclitaxel on day 3 of a 21 day cycle
1156384|NCT00421889|E4|Reported Event|Part D: Bladder Cancer MTD (N=15)|PXD101: 1000 mg/m² 30-minute IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Carboplatin: AUC 5 IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m² IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3
1156385|NCT00421889|E3|Reported Event|Part C: 3-6 Hours Infusion (N=7)|PXD: 1000 mg/m² was administered as a 3 or 6 hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
1156434|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
1156435|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
1156386|NCT00421889|E2|Reported Event|Part B: Ovarian Cancer MTD (N=35)|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
1156387|NCT00421889|E1|Reported Event|Part A: Dose Escalation (N=23)|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
1156388|NCT00421603|B3|Baseline|Total|Total of all reporting groups
1156389|NCT00421603|B2|Baseline|Placebo|Placebo daily dose
1156390|NCT00421603|B1|Baseline|Adderall-XR and Topiramate|Adderall-XR doses were titrated over two weeks to a maximum dose of 60 mg daily and topiramate doses were titrated over six weeks to a maximum dose of 150 mg twice daily.
1156391|NCT00421603|P2|Participant Flow|Placebo|Placebo daily dose
1156392|NCT00421603|P1|Participant Flow|Adderall-XR and Topiramate|Adderall-XR doses were titrated over two weeks to a maximum dose of 60 mg daily and topiramate doses were titrated over six weeks to a maximum dose of 150 mg twice daily.
1156393|NCT00421603|O2|Outcome|Placebo|Placebo daily dose
1156394|NCT00421603|O1|Outcome|Adderall-XR and Topiramate|Adderall-XR doses were titrated over two weeks to a maximum dose of 60 mg daily and topiramate doses were titrated over six weeks to a maximum dose of 150 mg twice daily.
1156395|NCT00421603|E2|Reported Event|Placebo|Placebo daily dose
1156396|NCT00421603|E1|Reported Event|Adderall-XR and Topiramate|Adderall-XR doses were titrated over two weeks to a maximum dose of 60 mg daily and topiramate doses were titrated over six weeks to a maximum dose of 150 mg twice daily.
1156397|NCT00421408|B3|Baseline|Total|Total of all reporting groups
1156457|NCT00420992|P1|Participant Flow|ALO-01|
1156458|NCT00420992|O2|Outcome|Placebo|
1156400|NCT00421408|P2|Participant Flow|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).~Whey protein supplement : 40-g whey protein supplement daily for 18 months"
1156401|NCT00421408|P1|Participant Flow|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).~Placebo : Placebo supplement daily for 18 months"
1156402|NCT00421408|O2|Outcome|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).~Whey protein supplement : 40-g whey protein supplement daily for 18 months"
1156403|NCT00421408|O1|Outcome|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).~Placebo : Placebo supplement daily for 18 months"
1156404|NCT00421408|O2|Outcome|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).~Whey protein supplement : 40-g whey protein supplement daily for 18 months"
1156405|NCT00421408|O1|Outcome|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).~Placebo : Placebo supplement daily for 18 months"
1156406|NCT00421408|O2|Outcome|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).~Whey protein supplement : 40-g whey protein supplement daily for 18 months"
1156407|NCT00421408|O1|Outcome|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).~Placebo : Placebo supplement daily for 18 months"
1156408|NCT00421408|O2|Outcome|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).~Whey protein supplement : 40-g whey protein supplement daily for 18 months"
1156409|NCT00421408|O1|Outcome|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).~Placebo : Placebo supplement daily for 18 months"
1156410|NCT00421408|O2|Outcome|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).~Whey protein supplement : 40-g whey protein supplement daily for 18 months"
1156411|NCT00421408|O1|Outcome|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).~Placebo : Placebo supplement daily for 18 months"
1156412|NCT00421408|O2|Outcome|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).~Whey protein supplement : 40-g whey protein supplement daily for 18 months"
1156413|NCT00421408|O1|Outcome|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).~Placebo : Placebo supplement daily for 18 months"
1156414|NCT00421408|O2|Outcome|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).~Whey protein supplement : 40-g whey protein supplement daily for 18 months"
1156415|NCT00421408|O1|Outcome|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).~Placebo : Placebo supplement daily for 18 months"
1156416|NCT00421408|E2|Reported Event|Protein Powder 40 g Daily|
1156417|NCT00421408|E1|Reported Event|Placebo Carbohydrate Powder 40 g Daily|
1156418|NCT00421343|B1|Baseline|Osteoporosis Medication|Everyone received 1000 mg calcium per day plus vitamin D and alendronate 70mg per week.
1156419|NCT00421343|P1|Participant Flow|Osteoporosis Medication|Everyone received 1000 mg calcium per day plus vitamin D and alendronate 70mg per week.
1156420|NCT00421343|O1|Outcome|Osteoporosis Medication|Everyone received 1000 mg calcium per day plus vitamin D and alendronate 70mg per week.
1156421|NCT00421343|E1|Reported Event|Osteoporosis Medication|Everyone received 1000 mg calcium per day plus vitamin D and alendronate 70mg per week.
1156422|NCT00421174|B3|Baseline|Total|Total of all reporting groups
1156423|NCT00421174|B2|Baseline|Placebo|Placebo plus Corticosteroids
1156424|NCT00421174|B1|Baseline|Etanercept|Etanercept plus corticosteroids
1156425|NCT00421174|P2|Participant Flow|Placebo|Placebo plus Corticosteroids
1156426|NCT00421174|P1|Participant Flow|Etanercept|Etanercept plus corticosteroids
1156427|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
1156428|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
1156429|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
1156430|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
1156456|NCT00420992|P2|Participant Flow|Placebo|
1156464|NCT00420927|B7|Baseline|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
1156465|NCT00420927|B6|Baseline|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
1156466|NCT00420927|B5|Baseline|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
1156467|NCT00420927|B4|Baseline|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
1156468|NCT00420927|B3|Baseline|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
1156469|NCT00420927|B2|Baseline|PBO+MTX|Methotrexate (MTX) monotherapy plus blinded placebo(PBO) during Period 1
1156470|NCT00420927|B1|Baseline|ADA+MTX|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1
1156471|NCT00420927|P7|Participant Flow|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
1156472|NCT00420927|P6|Participant Flow|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
1156473|NCT00420927|P5|Participant Flow|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
1156474|NCT00420927|P4|Participant Flow|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
1156475|NCT00420927|P3|Participant Flow|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
1156476|NCT00420927|P2|Participant Flow|PBO+MTX|Methotrexate (MTX) monotherapy plus blinded placebo during Period 1
1156477|NCT00420927|P1|Participant Flow|ADA+MTX|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1
1156478|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
1156479|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
1156480|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
1156481|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
1156482|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
1156483|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
1156484|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
1156485|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
1156486|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
1156487|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
1156488|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
1156489|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
1156490|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
1156491|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
1156492|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
1156493|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
1156494|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
1156495|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
1156496|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
1156497|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
1156498|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
1156499|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
1156500|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
1156501|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
1156974|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156714|NCT00420628|B2|Baseline|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
1156502|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
1156503|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
1156504|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
1156505|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
1156506|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
1156507|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
1156508|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
1156509|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
1156510|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
1156511|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
1156512|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
1156513|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
1156514|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
1156515|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
1156516|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
1156517|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
1156518|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
1156519|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
1156520|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
1156521|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
1156522|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
1156523|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
1156524|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
1156525|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
1156526|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
1156527|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
1156528|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
1156529|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
1156530|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
1156531|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
1156532|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
1156533|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
1156534|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
1156535|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
1156536|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
1156537|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
1156575|NCT00420927|E5|Reported Event|PBO+MTX/OL ADA+MTX (Arm 5)|Blinded MTX monotherapy during Period 1, open-label combination therapy during Period 2
1156538|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
1163368|NCT00402987|O4|Outcome|Placebo|
1156539|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
1156540|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
1156541|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
1156542|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
1156543|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
1156544|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
1156545|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
1156546|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
1156547|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
1156548|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
1156549|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
1156550|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
1156551|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
1156552|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
1156553|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
1156554|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
1156555|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
1156556|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
1156557|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
1156558|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
1156559|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
1156560|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
1156561|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
1156562|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
1156563|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
1156564|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
1156565|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
1156566|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
1156567|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
1156568|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
1156569|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
1156570|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
1156571|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
1156572|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
1156573|NCT00420927|E7|Reported Event|Period 1 PBO+MTX|Combination therapy with methotrexate (MTX) and blinded placebo (PBO) during Period 1
1156574|NCT00420927|E6|Reported Event|Period 1 ADA+MTX|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1
1156576|NCT00420927|E4|Reported Event|PBO+MTX/PBO+MTX (Arm 4)|Blinded MTX monotherapy during Period 1 and Period 2
1157176|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
1156577|NCT00420927|E3|Reported Event|ADA+MTX/OL ADA+MTX (Arm 3)|Blinded combination therapy during Period 1, open-label combination therapy during Period 2
1156578|NCT00420927|E2|Reported Event|ADA+MTX/ADA+MTX (Arm 2)|Blinded combination ADA+MTX therapy during Period 1 and Period 2
1156579|NCT00420927|E1|Reported Event|ADA+MTX/PBO+MTX (Arm 1)|Blinded combination ADA+MTX therapy during Period 1 and blinded MTX monotherapy during Period 2
1156580|NCT00420849|B1|Baseline|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
1156581|NCT00420849|P1|Participant Flow|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
1156582|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
1156583|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
1156584|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
1156585|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
1156586|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
1156587|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
1156588|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
1156589|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
1156590|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
1156591|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
1156592|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
1156715|NCT00420628|B1|Baseline|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
1156593|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
1156594|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
1156595|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
1156596|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
1156597|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
1156598|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
1156599|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
1156600|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
1156601|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
1156602|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
1156603|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
1156604|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
1156605|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
1156668|NCT00420784|O3|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
1156648|NCT00420784|B2|Baseline|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
1163369|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
1156606|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
1156607|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
1156608|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
1156609|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
1156610|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
1156611|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
1156612|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
1156613|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
1156614|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
1156615|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
1156616|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
1156617|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
1156631|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
1156618|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
1156667|NCT00420784|O4|Outcome|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
1157177|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
1156619|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
1156620|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
1156621|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
1156622|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
1156623|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
1156624|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
1156625|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
1156626|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
1156627|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
1156628|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
1156629|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
1156630|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
1156716|NCT00420628|P2|Participant Flow|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
1157357|NCT00419263|B4|Baseline|Total|Total of all reporting groups
1156632|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
1156633|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
1156634|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
1156635|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
1156636|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
1156637|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
1156638|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
1156639|NCT00420849|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
1156640|NCT00420849|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
1156641|NCT00420849|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
1156642|NCT00420849|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
1156643|NCT00420849|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
1156644|NCT00420849|E1|Reported Event|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
1156645|NCT00420784|B5|Baseline|Total|Total of all reporting groups
1156646|NCT00420784|B4|Baseline|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
1156647|NCT00420784|B3|Baseline|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
1156697|NCT00420745|E1|Reported Event|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
1156698|NCT00420017|B3|Baseline|Total|Total of all reporting groups
1156649|NCT00420784|B1|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
1156650|NCT00420784|P4|Participant Flow|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
1156651|NCT00420784|P3|Participant Flow|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
1156652|NCT00420784|P2|Participant Flow|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
1156653|NCT00420784|P1|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
1156654|NCT00420784|O1|Outcome|Telaprevir|"All subjects who received single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week reporting group and for 24 weeks in Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week and Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week reporting groups."
1156655|NCT00420784|O4|Outcome|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
1156656|NCT00420784|O3|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
1156657|NCT00420784|O2|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
1156658|NCT00420784|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
1156659|NCT00420784|O4|Outcome|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
1156660|NCT00420784|O3|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
1156661|NCT00420784|O2|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
1156662|NCT00420784|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
1156663|NCT00420784|O4|Outcome|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
1156664|NCT00420784|O3|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
1156665|NCT00420784|O2|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
1156694|NCT00420745|O2|Outcome|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
1156975|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156666|NCT00420784|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
1156669|NCT00420784|O2|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
1156670|NCT00420784|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
1156671|NCT00420784|O4|Outcome|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
1156672|NCT00420784|O3|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
1156673|NCT00420784|O2|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
1156674|NCT00420784|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
1156675|NCT00420784|E4|Reported Event|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
1156676|NCT00420784|E3|Reported Event|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
1156677|NCT00420784|E2|Reported Event|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
1156678|NCT00420784|E1|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
1156679|NCT00420745|B3|Baseline|Total|Total of all reporting groups
1156680|NCT00420745|B2|Baseline|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
1156681|NCT00420745|B1|Baseline|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
1156682|NCT00420745|P2|Participant Flow|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
1156683|NCT00420745|P1|Participant Flow|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
1156684|NCT00420745|O2|Outcome|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
1156685|NCT00420745|O1|Outcome|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
1156686|NCT00420745|O2|Outcome|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
1156687|NCT00420745|O1|Outcome|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
1156688|NCT00420745|O2|Outcome|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
1156689|NCT00420745|O1|Outcome|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
1156690|NCT00420745|O2|Outcome|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
1156691|NCT00420745|O1|Outcome|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
1156692|NCT00420745|O2|Outcome|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
1156693|NCT00420745|O1|Outcome|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
1156976|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156695|NCT00420745|O1|Outcome|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
1156696|NCT00420745|E2|Reported Event|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
1156699|NCT00420017|B2|Baseline|Control|Control usual care
1156717|NCT00420628|P1|Participant Flow|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
1156718|NCT00420628|O2|Outcome|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
1156719|NCT00420628|O1|Outcome|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
1156720|NCT00420628|O2|Outcome|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
1156721|NCT00420628|O1|Outcome|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
1156722|NCT00420628|O2|Outcome|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
1156723|NCT00420628|O1|Outcome|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
1156724|NCT00420628|O2|Outcome|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
1156725|NCT00420628|O1|Outcome|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
1156726|NCT00420628|O2|Outcome|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
1156727|NCT00420628|O1|Outcome|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
1156728|NCT00420628|E2|Reported Event|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
1156729|NCT00420628|E1|Reported Event|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
1156730|NCT00420511|B3|Baseline|Total|Total of all reporting groups
1156731|NCT00420511|B2|Baseline|Placebo|Matching placebo once daily and metformin 1000 mg twice a day (bid) by mouth (po)
1156732|NCT00420511|B1|Baseline|Sitagliptin|Sitagliptin 100 mg once daily and metformin 1000 mg twice a day (bid) by mouth po
1156733|NCT00420511|P2|Participant Flow|Placebo|Matching placebo once daily and metformin 1000 mg twice a day (bid) by mouth (po)
1156734|NCT00420511|P1|Participant Flow|Sitagliptin|Sitagliptin 100 mg once daily and metformin 1000 mg twice a day (bid) by mouth po
1156735|NCT00420511|O2|Outcome|Placebo|Matching placebo once daily and metformin 1000 mg twice a day (bid) by mouth (po)
1156736|NCT00420511|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily and metformin 1000 mg twice a day (bid) by mouth po
1156737|NCT00420511|O2|Outcome|Placebo|Matching placebo once daily and metformin 1000 mg twice a day (bid) by mouth (po)
1156738|NCT00420511|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily and metformin 1000 mg twice a day (bid) by mouth po
1156739|NCT00420511|O2|Outcome|Placebo|Matching placebo once daily and metformin 1000 mg twice a day (orally administered)
1156740|NCT00420511|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily and metformin 1000 mg twice a day (orally administered)
1156741|NCT00420511|E2|Reported Event|Placebo|Matching placebo once daily and metformin 1000 mg twice a day (bid) by mouth (po)
1156742|NCT00420511|E1|Reported Event|Sitagliptin|Sitagliptin 100 mg once daily and metformin 1000 mg twice a day (bid) by mouth po
1156743|NCT00420459|B1|Baseline|Open-label Aripiprazole|Twelve subjects received open-label aripiprazole for 12 weeks. Mean dose, 9.8 mg/day
1156744|NCT00420459|P1|Participant Flow|Open-label Aripiprazole|Twelve subjects received open-label aripiprazole, mean final dose was 9.8 mg /day.
1156745|NCT00420459|O1|Outcome|Open-label Aripiprazole|Twelve subjects received open-label aripiprazole for 12 weeks. Mean dose, 9.8 mg/day
1156746|NCT00420459|O1|Outcome|Open-label Aripiprazole|Twelve subjects received open-label aripiprazole for 12 weeks. Mean dose, 9.8 mg/day
1156747|NCT00420459|O1|Outcome|Open-label Aripiprazole|Twelve subjects received open-label aripiprazole for 12 weeks. Mean dose, 9.8 mg/day
1156748|NCT00420459|O1|Outcome|Open-label Aripiprazole|Twelve subjects received open-label aripiprazole for 12 weeks. Mean dose, 9.8 mg/day
1156749|NCT00420459|O1|Outcome|Open-label Aripiprazole|Twelve subjects received open-label aripiprazole, mean final dose was 9.8 mg /day.
1156750|NCT00420459|O1|Outcome|Open-label Aripiprazole|Twelve subjects received open-label aripiprazole. Mean final dose was 9.8 mg/day
1156751|NCT00420459|E1|Reported Event|Aripiprazole|
1156752|NCT00420420|B3|Baseline|Total|Total of all reporting groups
1156753|NCT00420420|B2|Baseline|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
1156754|NCT00420420|B1|Baseline|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
1156755|NCT00420420|P2|Participant Flow|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
1156756|NCT00420420|P1|Participant Flow|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
1156757|NCT00420420|O2|Outcome|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
1156758|NCT00420420|O1|Outcome|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
1156759|NCT00420420|O2|Outcome|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
1156760|NCT00420420|O1|Outcome|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
1156761|NCT00420420|O2|Outcome|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
1156762|NCT00420420|O1|Outcome|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
1156763|NCT00420420|O2|Outcome|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
1158713|NCT00414167|B3|Baseline|Total|Total of all reporting groups
1156764|NCT00420420|O1|Outcome|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
1156765|NCT00420420|O2|Outcome|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
1156766|NCT00420420|O1|Outcome|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
1156767|NCT00420420|O2|Outcome|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
1156768|NCT00420420|O1|Outcome|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
1156769|NCT00420420|E2|Reported Event|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
1156770|NCT00420420|E1|Reported Event|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
1156771|NCT00420407|B3|Baseline|Total|Total of all reporting groups
1156772|NCT00420407|B2|Baseline|Vasopressin|"Vasopressin~vasopressin : vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours"
1156773|NCT00420407|B1|Baseline|Normal Saline|"bolus of NS followed by continuous infusion of NS, no vasopressin added~normal saline control : no vasopressin added to bolus or 5 hour continuous infusion"
1156774|NCT00420407|P2|Participant Flow|Vasopressin|"Vasopressin~vasopressin : vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours"
1156775|NCT00420407|P1|Participant Flow|Normal Saline|"bolus of NS followed by continuous infusion of NS, no vasopressin added~normal saline control : no vasopressin added to bolus or 5 hour continuous infusion"
1156776|NCT00420407|O2|Outcome|Vasopressin|
1156777|NCT00420407|O1|Outcome|Normal Saline|
1156778|NCT00420407|E2|Reported Event|Vasopressin|"Vasopressin~vasopressin : vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours"
1156779|NCT00420407|E1|Reported Event|Normal Saline|"bolus of NS followed by continuous infusion of NS, no vasopressin added~normal saline control : no vasopressin added to bolus or 5 hour continuous infusion"
1156780|NCT00420342|B4|Baseline|Total|Total of all reporting groups
1156781|NCT00420342|B3|Baseline|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156782|NCT00420342|B2|Baseline|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156783|NCT00420342|B1|Baseline|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156784|NCT00420342|P3|Participant Flow|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156785|NCT00420342|P2|Participant Flow|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156786|NCT00420342|P1|Participant Flow|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156787|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156788|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156789|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156790|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156791|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156792|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156793|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156794|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156795|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156796|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156797|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156798|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156799|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156800|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156801|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156802|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156803|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156804|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156805|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156806|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1163370|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
1156807|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156808|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156809|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156810|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156811|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156812|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156813|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156814|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156815|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156816|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156817|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156818|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156819|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156820|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156821|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156822|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156823|NCT00420342|E3|Reported Event|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156824|NCT00420342|E2|Reported Event|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156825|NCT00420342|E1|Reported Event|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
1156826|NCT00420316|B3|Baseline|Total|Total of all reporting groups
1156827|NCT00420316|B2|Baseline|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
1156828|NCT00420316|B1|Baseline|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
1156829|NCT00420316|P2|Participant Flow|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
1156830|NCT00420316|P1|Participant Flow|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
1156831|NCT00420316|O2|Outcome|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
1156832|NCT00420316|O1|Outcome|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
1156833|NCT00420316|O2|Outcome|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
1156834|NCT00420316|O1|Outcome|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
1156868|NCT00420290|P1|Participant Flow|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
1156835|NCT00420316|O2|Outcome|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
1156836|NCT00420316|O1|Outcome|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
1156837|NCT00420316|O2|Outcome|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
1156838|NCT00420316|O1|Outcome|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
1156839|NCT00420316|O2|Outcome|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
1156840|NCT00420316|O1|Outcome|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
1156841|NCT00420316|O2|Outcome|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
1156842|NCT00420316|O1|Outcome|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
1156843|NCT00420316|O2|Outcome|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
1156844|NCT00420316|O1|Outcome|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
1156845|NCT00420316|O2|Outcome|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
1156846|NCT00420316|O1|Outcome|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
1156847|NCT00420316|O2|Outcome|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
1156848|NCT00420316|O1|Outcome|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
1156849|NCT00420316|E2|Reported Event|Placebo Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
1156850|NCT00420316|E1|Reported Event|Rotarix Group|Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
1156851|NCT00420303|B3|Baseline|Total|Total of all reporting groups
1156852|NCT00420303|B2|Baseline|Placebo|Subcutaneously once weekly
1156853|NCT00420303|B1|Baseline|Etanercept|50mg subcutaneously once weekly
1156854|NCT00420303|P2|Participant Flow|Placebo|Subcutaneously once weekly
1156855|NCT00420303|P1|Participant Flow|Etanercept|50mg subcutaneously once weekly
1156856|NCT00420303|O2|Outcome|Placebo|Subcutaneously once weekly
1156857|NCT00420303|O1|Outcome|Etanercept|50mg subcutaneously once weekly
1156858|NCT00420303|O2|Outcome|Placebo|Subcutaneously once weekly
1156859|NCT00420303|O1|Outcome|Etanercept|50mg subcutaneously once weekly
1156860|NCT00420303|O2|Outcome|Placebo|Subcutaneously once weekly
1156861|NCT00420303|O1|Outcome|Etanercept|50mg subcutaneously once weekly
1156862|NCT00420303|E2|Reported Event|Placebo|Subcutaneously once weekly
1156863|NCT00420303|E1|Reported Event|Etanercept|50mg subcutaneously once weekly
1156864|NCT00420290|B3|Baseline|Total|Total of all reporting groups
1156865|NCT00420290|B2|Baseline|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
1156866|NCT00420290|B1|Baseline|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
1156867|NCT00420290|P2|Participant Flow|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
1156869|NCT00420290|O2|Outcome|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
1156870|NCT00420290|O1|Outcome|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
1156871|NCT00420290|O2|Outcome|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
1163371|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1156872|NCT00420290|O1|Outcome|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
1156873|NCT00420290|O2|Outcome|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
1156874|NCT00420290|O1|Outcome|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
1156875|NCT00420290|O2|Outcome|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
1156876|NCT00420290|O1|Outcome|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
1156877|NCT00420290|O2|Outcome|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
1156878|NCT00420290|O1|Outcome|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
1156879|NCT00420290|E2|Reported Event|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
1156880|NCT00420290|E1|Reported Event|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
1156881|NCT00420238|B3|Baseline|Total|Total of all reporting groups
1156882|NCT00420238|B2|Baseline|Placebo|Subcutaneously (SC), once weekly
1156883|NCT00420238|B1|Baseline|Etanercept|50 mg subcutaneously (SC), once weekly
1156884|NCT00420238|P2|Participant Flow|Placebo/Etanercept|Placebo subcutaneously (SC), once weekly; Etanercept 50 mg SC, once weekly
1156885|NCT00420238|P1|Participant Flow|Etanercept/Etanercept|Etanercept 50 mg subcutaneously (SC) once weekly
1156886|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
1156887|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
1156888|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156889|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156890|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
1156891|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
1156892|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156893|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156894|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
1156895|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
1156896|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
1156897|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
1156898|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156899|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156900|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156901|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156902|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
1156903|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
1156904|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156905|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156906|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156907|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156908|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
1156909|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
1156910|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156911|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156912|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
1156913|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
1156914|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156915|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156916|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156917|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156918|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
1156919|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
1156920|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156921|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156922|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
1156923|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
1156924|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156925|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156926|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
1156927|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
1156928|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156929|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156930|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
1156931|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
1156932|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156933|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156934|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
1156935|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
1156936|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156937|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156938|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
1156939|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
1156940|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156941|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156942|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156943|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156944|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156945|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156946|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156947|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156948|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156949|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156950|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
1156951|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
1156952|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156953|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156954|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156955|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156956|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: placebo subcutaneously (SC), once weekly; Open-label Period 2: etanercept subcutaneously (SC), once weekly
1156957|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
1156958|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156959|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156960|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
1156961|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
1156962|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156963|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156964|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
1156965|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
1156966|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156967|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156968|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156969|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156970|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156971|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156972|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
1156973|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
1156977|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156978|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
1156979|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
1156980|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156981|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156982|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156983|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156984|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
1156985|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
1156986|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156987|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156988|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156989|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156990|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
1156991|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
1156992|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156993|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156994|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156995|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1156996|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: placebo subcutaneously (SC), once weekly; Open-label Period 2: etanercept subcutaneously (SC), once weekly
1156997|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
1156998|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1156999|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1157000|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: placebo subcutaneously (SC), once weekly; Open-label Period 2: etanercept subcutaneously (SC), once weekly
1157001|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
1157002|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1157003|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1157004|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: placebo subcutaneously (SC), once weekly; Open-label Period 2: etanercept subcutaneously (SC), once weekly
1157005|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
1157006|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1157007|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1157008|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: placebo subcutaneously (SC), once weekly; Open-label Period 2: etanercept subcutaneously (SC), once weekly
1157009|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: etanercept 50 mg subcutaneously (SC), once weekly
1157010|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1157011|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1157012|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1157013|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1157014|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
1157015|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
1157016|NCT00420238|E4|Reported Event|Placebo/Etanercept|Double-blind Period 1: placebo subcutaneously (SC), once weekly; Open-label Period 2: etanercept subcutaneously (SC), once weekly
1157017|NCT00420238|E3|Reported Event|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
1157018|NCT00420238|E2|Reported Event|Placebo|Double-blind Period 1: placebo subcutaneously (SC), once weekly
1157019|NCT00420238|E1|Reported Event|Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly
1157020|NCT00420212|B4|Baseline|Total|Total of all reporting groups
1157021|NCT00420212|B3|Baseline|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
1157022|NCT00420212|B2|Baseline|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
1157023|NCT00420212|B1|Baseline|Placebo|Participants received two placebo capsules orally three times daily (TID)
1157024|NCT00420212|P3|Participant Flow|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
1157025|NCT00420212|P2|Participant Flow|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
1157026|NCT00420212|P1|Participant Flow|Placebo|Participants received two placebo capsules orally three times daily (TID)
1157027|NCT00420212|O3|Outcome|BG00012 240 mg TID|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
1157028|NCT00420212|O2|Outcome|BG00012 240 mg BID|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
1157029|NCT00420212|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
1157030|NCT00420212|O3|Outcome|BG00012 240 mg TID|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
1157031|NCT00420212|O2|Outcome|BG00012 240 mg BID|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
1157032|NCT00420212|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
1157033|NCT00420212|O3|Outcome|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
1157034|NCT00420212|O2|Outcome|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
1157035|NCT00420212|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
1157036|NCT00420212|O3|Outcome|BG00012 240 mg TID|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
1157037|NCT00420212|O2|Outcome|BG00012 240 mg BID|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
1157038|NCT00420212|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
1157039|NCT00420212|O3|Outcome|BG00012 240 mg TID|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
1157040|NCT00420212|O2|Outcome|BG00012 240 mg BID|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
1157041|NCT00420212|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
1157042|NCT00420212|O3|Outcome|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
1157043|NCT00420212|O2|Outcome|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
1157044|NCT00420212|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
1157045|NCT00420212|E4|Reported Event|Total BG00012|Combined BG00012 240 mg twice daily (BID) dose group and BG00012 240 mg 3 times daily (TID) dose group
1157046|NCT00420212|E3|Reported Event|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
1157047|NCT00420212|E2|Reported Event|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
1157048|NCT00420212|E1|Reported Event|Placebo|Participants received two placebo capsules orally three times daily (TID)
1157049|NCT00420199|B3|Baseline|Total|Total of all reporting groups
1157050|NCT00420199|B2|Baseline|Placebo (PLA) + MTX|PLA was administered IV on Day 1, 15, 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of MTX of at least 15 mg or a maximum tolerated dose (ie, 10 mg weekly)
1157051|NCT00420199|B1|Baseline|Abatacept (ABA) + Methotrexate (MTX)|Abatacept was administered IV on Day 1, 15, 29 and every 28 days up to and including Day 113.Abatacept was given as a dose based on body weight: 500 mg for participants weighing < 60 kg, 750 mg for participants weighing 60 to 100 kg and 1 gram for participants weighing > 100 kg.
1157052|NCT00420199|P2|Participant Flow|Placebo (PLA) + MTX|PLA was administered IV on Day 1, 15, 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of MTX of at least 15 mg or a maximum tolerated dose (ie, 10 mg weekly)
1157053|NCT00420199|P1|Participant Flow|Abatacept (ABA) + Methotrexate (MTX)|Abatacept was administered intravenously (IV) on Day 1, 15, 29 and every 28 days up to and including Day 113.Abatacept was given as a dose based on body weight: 500 mg for participants weighing < 60 kg, 750 mg for participants weighing 60 to 100 kg and 1 gram for participants weighing > 100 kg.
1157054|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
1157055|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
1157056|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
1157057|NCT00420199|O2|Outcome|Placebo (PLA) + MTX|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate).
1157058|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
1157059|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
1157060|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
1157061|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
1157062|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
1157063|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
1157064|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
1157065|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
1157066|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
1157067|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
1157068|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
1157069|NCT00420199|O2|Outcome|Placebo (PLA) + MTX|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
1157070|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
1157071|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
1157072|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
1157073|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
1157074|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
1157075|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
1157076|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
1157077|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
1157078|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
1157079|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
1157080|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
1157081|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
1157082|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
1157083|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
1157084|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
1157085|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
1157086|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
1157087|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
1157088|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
1157089|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
1157090|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
1157091|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
1157092|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
1157093|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
1157094|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
1157095|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate).
1157096|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered intravenously on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
1157097|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
1157098|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
1157099|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
1157100|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered intravenously on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
1157101|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate).
1157102|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered intravenously on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
1157103|NCT00420199|E2|Reported Event|PLA + MTX|PLA was administered IV on Day 1, 15, 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of MTX of at least 15 mg or a maximum tolerated dose (ie, 10 mg weekly)
1157104|NCT00420199|E1|Reported Event|ABA + MTX|Abatacept was administered IV on Day 1, 15, 29 and every 28 days up to and including Day 113.Abatacept was given as a dose based on body weight: 500 mg for participants weighing < 60 kg, 750 mg for participants weighing 60 to 100 kg and 1 gram for participants weighing > 100 kg. In addition, participants received a weekly dose of MTX of at least 15 mg or a maximum tolerated dose (ie, 10 mg weekly)
1157105|NCT00420147|B3|Baseline|Total|Total of all reporting groups
1157106|NCT00420147|B2|Baseline|Medial Knee OA - Treatment|These subjects have tibio-femoral medial knee compartment osteoarthritis and wore a wedged in-shoe orthosis as their treatment.
1157107|NCT00420147|B1|Baseline|Medial Knee OA - Control|These subjects have tibio-femoral medial knee compartment osteoarthritis and wore a neutral (non-wedged) in-shoe orthosis as their treatment.
1157108|NCT00420147|P2|Participant Flow|Medial Knee OA - Treatment|These subjects have tibio-femoral medial knee compartment osteoarthritis and were prescribed a laterally wedged in shoe orthosis
1157109|NCT00420147|P1|Participant Flow|Medial Knee OA - Control|These subjects have tibio-femoral medial knee compartment osteoarthritis and were prescribed a neutral in shoe orthosis
1157110|NCT00420147|O2|Outcome|Medial Knee OA - Treatment|These subjects have tibio-femoral medial knee compartment osteoarthritis
1157111|NCT00420147|O1|Outcome|Medial Knee OA - Control|These subjects have tibio-femoral medial knee compartment osteoarthritis
1157112|NCT00420147|O2|Outcome|Medial Knee OA - Treatment|These subjects have tibio-femoral medial knee compartment osteoarthritis
1157113|NCT00420147|O1|Outcome|Medial Knee OA - Control|These subjects have tibio-femoral medial knee compartment osteoarthritis
1157114|NCT00420147|E2|Reported Event|Medial Knee OA - Treatment|These subjects have tibio-femoral medial knee compartment osteoarthritis. They were prescribed and wore a laterally wedged in-shoe orthosis.
1157115|NCT00420147|E1|Reported Event|Medial Knee OA - Control|These subjects have tibio-femoral medial knee compartment osteoarthritis. They were prescribed and wore a neutral in-shoe orthosis.
1157116|NCT00420095|B3|Baseline|Total|Total of all reporting groups
1158714|NCT00414167|B2|Baseline|Placebo|"Placebo~Placebo : Placebo"
1157117|NCT00420095|B2|Baseline|Insulin Lispro Low Mix First, Then Human Insulin Mix 30/70|Insulin lispro low mix for 12 weeks followed by human insulin mix 30/70 for 12 weeks
1157118|NCT00420095|B1|Baseline|Human Insulin Mix 30/70 First, Then Insulin Lispro Low Mix|Human insulin mix 30/70 for 12 weeks followed by insulin lispro low mix for 12 weeks
1163372|NCT00402987|O3|Outcome|Placebo|
1157119|NCT00420095|P2|Participant Flow|Insulin Lispro Low Mix First, Then Human Insulin Mix 30/70|Insulin lispro low mix for 12 weeks followed by human insulin mix 30/70 for 12 weeks
1157120|NCT00420095|P1|Participant Flow|Human Insulin Mix 30/70 First, Then Insulin Lispro Low Mix|Human insulin mix 30/70 for 12 weeks followed by insulin lispro low mix for 12 weeks
1157121|NCT00420095|O2|Outcome|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
1157122|NCT00420095|O1|Outcome|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
1157123|NCT00420095|O2|Outcome|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
1157124|NCT00420095|O1|Outcome|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
1157125|NCT00420095|O2|Outcome|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
1157126|NCT00420095|O1|Outcome|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
1157127|NCT00420095|O2|Outcome|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
1157128|NCT00420095|O1|Outcome|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
1157129|NCT00420095|O2|Outcome|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
1157130|NCT00420095|O1|Outcome|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
1157131|NCT00420095|O2|Outcome|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
1157132|NCT00420095|O1|Outcome|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
1157133|NCT00420095|O2|Outcome|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
1157134|NCT00420095|O1|Outcome|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
1157135|NCT00420095|E2|Reported Event|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
1157136|NCT00420095|E1|Reported Event|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
1157137|NCT00420056|B1|Baseline|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
1157138|NCT00420056|P1|Participant Flow|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
1157139|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
1157140|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
1157141|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
1157142|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
1157143|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
1157144|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
1157145|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
1163300|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
1157146|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
1157147|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
1157148|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
1157149|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
1157150|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
1157151|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
1157152|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
1157153|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
1157154|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
1157155|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
1157156|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
1157157|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
1157158|NCT00420056|E1|Reported Event|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
1157159|NCT00419952|B3|Baseline|Total|Total of all reporting groups
1157160|NCT00419952|B2|Baseline|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
1157161|NCT00419952|B1|Baseline|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
1157162|NCT00419952|P2|Participant Flow|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
1157163|NCT00419952|P1|Participant Flow|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
1157164|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
1157165|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
1157166|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
1157167|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
1157168|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
1157169|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
1157170|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
1157171|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
1157172|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
1157173|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
1157174|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
1163373|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
1157178|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
1157179|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
1157180|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
1157181|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
1157182|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
1157183|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
1157184|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
1157185|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
1157186|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
1157187|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
1157188|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
1157189|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
1157190|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
1157191|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
1157192|NCT00419952|E2|Reported Event|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
1157193|NCT00419952|E1|Reported Event|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
1157194|NCT00419926|B3|Baseline|Total|Total of all reporting groups
1157195|NCT00419926|B2|Baseline|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
1157196|NCT00419926|B1|Baseline|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
1157197|NCT00419926|P2|Participant Flow|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
1157198|NCT00419926|P1|Participant Flow|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
1157199|NCT00419926|O2|Outcome|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
1157200|NCT00419926|O1|Outcome|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
1157201|NCT00419926|O2|Outcome|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
1157202|NCT00419926|O1|Outcome|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
1157203|NCT00419926|O2|Outcome|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
1157204|NCT00419926|O1|Outcome|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
1157205|NCT00419926|O2|Outcome|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
1157206|NCT00419926|O1|Outcome|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
1157207|NCT00419926|O2|Outcome|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
1157208|NCT00419926|O1|Outcome|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
1157209|NCT00419926|E2|Reported Event|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
1157210|NCT00419926|E1|Reported Event|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
1157211|NCT00419770|B3|Baseline|Total|Total of all reporting groups
1157212|NCT00419770|B2|Baseline|Placebo|Placebo control plus background liposomal amphotericin
1157213|NCT00419770|B1|Baseline|Deferasirox|Deferasirox plus liposomal amphotericin
1157214|NCT00419770|P2|Participant Flow|Placebo|Placebo control plus background liposomal amphotericin
1157215|NCT00419770|P1|Participant Flow|Deferasirox|Deferasirox plus liposomal amphotericin
1157216|NCT00419770|O2|Outcome|Placebo|Placebo control plus background liposomal amphotericin
1157217|NCT00419770|O1|Outcome|Deferasirox|Deferasirox plus liposomal amphotericin
1157218|NCT00419770|E2|Reported Event|Placebo|Placebo control plus background liposomal amphotericin
1157219|NCT00419770|E1|Reported Event|Deferasirox|Deferasirox plus liposomal amphotericin
1157220|NCT00419757|B3|Baseline|Total|Total of all reporting groups
1157221|NCT00419757|B2|Baseline|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
1157222|NCT00419757|B1|Baseline|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
1157223|NCT00419757|P2|Participant Flow|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
1157224|NCT00419757|P1|Participant Flow|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
1157225|NCT00419757|O2|Outcome|Budesonide|budesonide HFA pMDI 160 μg x 2 actuations twice daily
1157226|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily
1157227|NCT00419757|O2|Outcome|Budesonide|budesonide HFA pMDI 160 μg x 2 actuations twice daily
1157228|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily
1157229|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
1157230|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
1157231|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
1157232|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
1157233|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
1157234|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
1157235|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
1157236|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
1157237|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
1157238|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
1157239|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
1157240|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
1157241|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
1157242|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
1157243|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
1157244|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
1157245|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
1157246|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
1157247|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
1157248|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
1157249|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
1157250|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
1157251|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
1157252|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
1157253|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
1157254|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
1157255|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
1157256|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
1157257|NCT00419757|E2|Reported Event|Budesonide|budesonide HFA pMDI 160 μg x 2 actuations twice daily
1157258|NCT00419757|E1|Reported Event|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily
1157259|NCT00419744|B4|Baseline|Total|Total of all reporting groups
1157260|NCT00419744|B3|Baseline|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
1157261|NCT00419744|B2|Baseline|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
1157262|NCT00419744|B1|Baseline|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
1157263|NCT00419744|P3|Participant Flow|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
1157264|NCT00419744|P2|Participant Flow|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
1157265|NCT00419744|P1|Participant Flow|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
1157266|NCT00419744|O3|Outcome|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
1157267|NCT00419744|O2|Outcome|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
1157268|NCT00419744|O1|Outcome|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
1157269|NCT00419744|O3|Outcome|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
1157557|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
1157270|NCT00419744|O2|Outcome|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
1157271|NCT00419744|O1|Outcome|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
1157272|NCT00419744|O3|Outcome|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
1157273|NCT00419744|O2|Outcome|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
1157274|NCT00419744|O1|Outcome|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
1157275|NCT00419744|O3|Outcome|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
1157276|NCT00419744|O2|Outcome|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
1157277|NCT00419744|O1|Outcome|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
1157278|NCT00419744|O3|Outcome|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
1157279|NCT00419744|O2|Outcome|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
1157280|NCT00419744|O1|Outcome|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
1157281|NCT00419744|O3|Outcome|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
1157282|NCT00419744|O2|Outcome|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
1157283|NCT00419744|O1|Outcome|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
1157284|NCT00419744|O3|Outcome|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
1157285|NCT00419744|O2|Outcome|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
1157286|NCT00419744|O1|Outcome|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
1157287|NCT00419744|O3|Outcome|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
1157288|NCT00419744|O2|Outcome|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
1157289|NCT00419744|O1|Outcome|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
1157290|NCT00419744|E3|Reported Event|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
1157291|NCT00419744|E2|Reported Event|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
1157292|NCT00419744|E1|Reported Event|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
1157293|NCT00419445|B4|Baseline|Total|Total of all reporting groups
1157294|NCT00419445|B3|Baseline|150 mg Tid|
1157295|NCT00419445|B2|Baseline|75 mg Tid|
1157296|NCT00419445|B1|Baseline|25 mg Tid|
1157297|NCT00419445|P3|Participant Flow|150 mg Tid|
1157298|NCT00419445|P2|Participant Flow|75 mg Tid|
1157299|NCT00419445|P1|Participant Flow|25 mg Tid|
1157300|NCT00419445|O3|Outcome|150 mg Tid|
1157301|NCT00419445|O2|Outcome|75 mg Tid|
1157302|NCT00419445|O1|Outcome|25 mg Tid|
1157303|NCT00419445|E3|Reported Event|150 mg Tid|
1157304|NCT00419445|E2|Reported Event|75 mg Tid|
1157305|NCT00419445|E1|Reported Event|25 mg Tid|
1157306|NCT00419393|B1|Baseline|Keppra XR (Levetiracetam XR)|1000 – 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
1157307|NCT00419393|P1|Participant Flow|Keppra XR (Levetiracetam XR)|1000 – 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
1157308|NCT00419393|O1|Outcome|Keppra XR|1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
1157309|NCT00419393|O1|Outcome|Keppra XR|1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
1157310|NCT00419393|O1|Outcome|Keppra XR|1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
1157311|NCT00419393|O1|Outcome|Keppra XR|1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
1157312|NCT00419393|O1|Outcome|Keppra XR|1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
1157313|NCT00419393|E1|Reported Event|Keppra XR (Levetiracetam XR)|1000 – 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
1157314|NCT00419380|B3|Baseline|Total|Total of all reporting groups
1157315|NCT00419380|B2|Baseline|Ofloxin|dornase alfa (Pulmozyme®): This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
1157316|NCT00419380|B1|Baseline|Dornase Alfa (Pulmozyme®)|dornase alfa (Pulmozyme®): This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
1157317|NCT00419380|P2|Participant Flow|Ofloxin|dornase alfa (Pulmozyme®): This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
1158391|NCT00415051|O1|Outcome|Single Group Assignment|"RVF MP-12~RVF MP-12: Administer 1 ml SQ"
1157318|NCT00419380|P1|Participant Flow|Dornase Alfa (Pulmozyme®)|dornase alfa (Pulmozyme®): This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
1157319|NCT00419380|O2|Outcome|Ofloxin|Ofloxin: 5 drops twice daily for 7 days to the affected ear. Right ear n=11; Left ear n=12
1157320|NCT00419380|O1|Outcome|Dornase Alfa (Pulmozyme®)|dornase alfa (Pulmozyme®): 5 drops twice daily for 7 days to the affected ear. Right ear n=8; Left ear n= 15
1157321|NCT00419380|O2|Outcome|Ofloxin|Ofloxin: 5 drops twice daily for 7 days to the affected ear. Right ear n=11; Left ear n=12
1157322|NCT00419380|O1|Outcome|Dornase Alfa (Pulmozyme®)|dornase alfa (Pulmozyme®): 5 drops twice daily for 7 days to the affected ear. Right ear n=8; Left ear n= 15
1157323|NCT00419380|E2|Reported Event|Ofloxin|dornase alfa (Pulmozyme®): This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
1157324|NCT00419380|E1|Reported Event|Dornase Alfa (Pulmozyme®)|dornase alfa (Pulmozyme®): This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
1157325|NCT00419341|B1|Baseline|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
1157326|NCT00419341|P1|Participant Flow|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
1157327|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
1157328|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
1157329|NCT00419341|O1|Outcome|IgPro20 (PK Substudy)|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
1157330|NCT00419341|O1|Outcome|IgPro20 (PK Substudy)|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
1157331|NCT00419341|O1|Outcome|IgPro20 (PK Substudy)|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
1157332|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
1157333|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
1157334|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
1157335|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
1157336|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
1157337|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
1157338|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
1157339|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
1157340|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
1157341|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
1157342|NCT00419341|O2|Outcome|IVIG (Privigen; Previous Study)|Privigen is a liquid formulation of normal human IgG at a concentration of 10% administered as an intravenous infusion every 3 or 4 weeks.
1157343|NCT00419341|O1|Outcome|IgPro20 (PK Substudy)|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
1157344|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
1157345|NCT00419341|E1|Reported Event|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
1157346|NCT00419315|B3|Baseline|Total|Total of all reporting groups
1157347|NCT00419315|B2|Baseline|Arm 2|"Usual care~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
1157348|NCT00419315|B1|Baseline|Arm 1|"Care management for alcohol dependence~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
1157349|NCT00419315|P2|Participant Flow|Arm 2|"Usual care~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
1157350|NCT00419315|P1|Participant Flow|Arm 1|"Care management for alcohol dependence~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
1157351|NCT00419315|O2|Outcome|Arm 2|"Usual care~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
1157352|NCT00419315|O1|Outcome|Arm 1|"Care management for alcohol dependence~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
1157353|NCT00419315|O2|Outcome|Arm 2|"Usual care~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
1157553|NCT00418834|B1|Baseline|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
1157354|NCT00419315|O1|Outcome|Arm 1|"Care management for alcohol dependence~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
1157355|NCT00419315|E2|Reported Event|Arm 2|"Usual care~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
1157356|NCT00419315|E1|Reported Event|Arm 1|"Care management for alcohol dependence~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
1157358|NCT00419263|B3|Baseline|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
1157359|NCT00419263|B2|Baseline|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
1157360|NCT00419263|B1|Baseline|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
1157361|NCT00419263|P3|Participant Flow|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
1157362|NCT00419263|P2|Participant Flow|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
1157363|NCT00419263|P1|Participant Flow|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
1157364|NCT00419263|O3|Outcome|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
1157365|NCT00419263|O2|Outcome|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
1157366|NCT00419263|O1|Outcome|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
1157367|NCT00419263|O3|Outcome|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
1157368|NCT00419263|O2|Outcome|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
1157369|NCT00419263|O1|Outcome|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
1157370|NCT00419263|O3|Outcome|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
1157371|NCT00419263|O2|Outcome|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
1157372|NCT00419263|O1|Outcome|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
1157373|NCT00419263|O3|Outcome|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
1157374|NCT00419263|O2|Outcome|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
1157375|NCT00419263|O1|Outcome|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
1157376|NCT00419263|O3|Outcome|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
1157377|NCT00419263|O2|Outcome|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
1157378|NCT00419263|O1|Outcome|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
1157379|NCT00419263|O3|Outcome|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
1157380|NCT00419263|O2|Outcome|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
1157381|NCT00419263|O1|Outcome|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
1157382|NCT00419263|O3|Outcome|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
1157383|NCT00419263|O2|Outcome|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
1157384|NCT00419263|O1|Outcome|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
1157385|NCT00419263|E4|Reported Event|Total|Total number of subjects who received at least 1 dose of study drug
1157386|NCT00419263|E3|Reported Event|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
1157387|NCT00419263|E2|Reported Event|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
1157388|NCT00419263|E1|Reported Event|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
1157389|NCT00419159|B3|Baseline|Total|Total of all reporting groups
1157390|NCT00419159|B2|Baseline|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
1157391|NCT00419159|B1|Baseline|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
1157392|NCT00419159|P2|Participant Flow|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
1157393|NCT00419159|P1|Participant Flow|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
1158715|NCT00414167|B1|Baseline|Bupropion|"Bupropion~bupropion : 300 mg per day for 8 weeks"
1157394|NCT00419159|O2|Outcome|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
1157395|NCT00419159|O1|Outcome|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
1157396|NCT00419159|O2|Outcome|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
1158392|NCT00415051|O1|Outcome|Single Group Assignment|"RVF MP-12~RVF MP-12: Administer 1 ml SQ"
1157397|NCT00419159|O1|Outcome|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
1157398|NCT00419159|O2|Outcome|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
1157399|NCT00419159|O1|Outcome|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
1157400|NCT00419159|O2|Outcome|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
1157401|NCT00419159|O1|Outcome|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
1157402|NCT00419159|O2|Outcome|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
1157403|NCT00419159|O1|Outcome|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
1157404|NCT00419159|E2|Reported Event|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
1157405|NCT00419159|E1|Reported Event|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
1157406|NCT00419120|B1|Baseline|Implanted Patients|Patients implanted with Tengion Neo-Bladder Augment
1157407|NCT00419120|P1|Participant Flow|Implanted Patients|Patients implanted with Tengion Neo-Bladder Augment
1157408|NCT00419120|O1|Outcome|Implanted Patients|Patients implanted with Tengion Neo-Bladder Augment
1157409|NCT00419120|O1|Outcome|Implanted Patients|Patients implanted with Tengion Neo-Bladder Augment
1157410|NCT00419120|E1|Reported Event|Safety Population|All patients undergoing screeing and meeting inclusion/exclusion criteria
1157411|NCT00419094|B3|Baseline|Total|Total of all reporting groups
1157412|NCT00419094|B2|Baseline|Keppra XR 2000 mg/Day|2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
1157413|NCT00419094|B1|Baseline|Keppra XR 1000 mg/Day|1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
1157414|NCT00419094|P2|Participant Flow|Keppra XR 2000 mg/Day|2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
1157415|NCT00419094|P1|Participant Flow|Keppra XR 1000 mg/Day|1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
1157416|NCT00419094|O2|Outcome|Keppra XR 2000 mg/Day|2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
1157417|NCT00419094|O1|Outcome|Keppra XR 1000 mg/Day|1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
1157418|NCT00419094|O2|Outcome|Keppra XR 2000 mg/Day|2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
1157419|NCT00419094|O1|Outcome|Keppra XR 1000 mg/Day|1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
1157420|NCT00419094|O2|Outcome|Keppra XR 2000 mg/Day|2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
1157421|NCT00419094|O1|Outcome|Keppra XR 1000 mg/Day|1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
1157422|NCT00419094|O2|Outcome|Keppra XR 2000 mg/Day|2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
1157423|NCT00419094|O1|Outcome|Keppra XR 1000 mg/Day|1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
1157424|NCT00419094|E2|Reported Event|Keppra XR 2000 mg/Day|2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
1157425|NCT00419094|E1|Reported Event|Keppra XR 1000 mg/Day|1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
1157426|NCT00417976|B1|Baseline|Bevacizumab|"Gemcitabine : 1000 mg/m2 over 100 minutes every 2 weeks.~Bevacizumab : 10 mg/kg every 2 weeks.~Infusional 5-Fluorouracil : 2400 mg/m2 over 48 hours every 2 weeks."
1157427|NCT00417976|P1|Participant Flow|Bevacizumab|"Gemcitabine : 1000 mg/m2 over 100 minutes every 2 weeks.~Bevacizumab : 10 mg/kg every 2 weeks.~Infusional 5-Fluorouracil : 2400 mg/m2 over 48 hours every 2 weeks."
1157428|NCT00417976|O1|Outcome|Bevacizumab|"Gemcitabine: 1000 mg/m2 over 100 minutes every 2 weeks.~Bevacizumab: 10 mg/kg every 2 weeks.~Infusional 5-Fluorouracil: 2400 mg/m2 over 48 hours every 2 weeks."
1157429|NCT00417976|O1|Outcome|Bevacizumab|"Gemcitabine : 1000 mg/m2 over 100 minutes every 2 weeks.~Bevacizumab : 10 mg/kg every 2 weeks.~Infusional 5-Fluorouracil : 2400 mg/m2 over 48 hours every 2 weeks."
1157430|NCT00417976|E1|Reported Event|Bevacizumab|"Gemcitabine: 1000 mg/m2 over 100 minutes every 2 weeks.~Bevacizumab: 10 mg/kg every 2 weeks.~Infusional 5-Fluorouracil: 2400 mg/m2 over 48 hours every 2 weeks."
1157431|NCT00417963|B1|Baseline|ViVexx Carotid Stent Group|placement of a bare metal stent for treatment of carotid artery stenosis
1157432|NCT00417963|P1|Participant Flow|ViVexx Carotid Stent Group|placement of a bare metal stent for treatment of carotid artery stenosis
1157433|NCT00417963|O2|Outcome|6 Month Restenosis|Number of participants with restenosis at 6 months from implantation.
1157434|NCT00417963|O1|Outcome|Stent Placement in the Carotid Artery|placement of a bare metal stent for treatment of carotid artery stenosis
1157435|NCT00417963|O1|Outcome|ViVexx Carotid Stent Group|placement of a bare metal stent for treatment of carotid artery stenosis
1157436|NCT00417963|O1|Outcome|Stent Placement in the Carotid Artery|placement of a bare metal stent for treatment of carotid artery stenosis
1157437|NCT00417963|O3|Outcome|Pivotal Cohort|Participants who were enrolled in the Pivotal cohort. All Pivotal subjects were included in the intention to treat analysis.
1157438|NCT00417963|O2|Outcome|Roll-in Cohort|Participants enrolled in the roll-in cohort of the study. Roll-in patients were not included in the intention to treat analysis.
1157439|NCT00417963|O1|Outcome|Stent Placement in the Carotid Artery|All subjects who received the ViVexx Carotid Stent.
1157440|NCT00417963|O3|Outcome|Pivotal Cohort|Participants who were enrolled in the Pivotal cohort. All Pivotal subjects were included in the intention to treat analysis.
1157441|NCT00417963|O2|Outcome|Roll-in Cohort|Participants enrolled in the roll-in cohort of the study. Roll-in patients were not included in the intention to treat analysis.
1157442|NCT00417963|O1|Outcome|Stent Placement in the Carotid Artery|All subjects who received the ViVexx Carotid Stent.
1157443|NCT00417963|O3|Outcome|Pivotal Cohort|Participants who were enrolled in the Pivotal cohort. All Pivotal subjects were included in the intention to treat analysis.
1157444|NCT00417963|O2|Outcome|Roll-in Cohort|Participants enrolled in the roll-in cohort of the study. Roll-in patients were not included in the intention to treat analysis.
1157445|NCT00417963|O1|Outcome|Stent Placement in the Carotid Artery|All subjects who received the ViVexx Carotid Stent.
1157446|NCT00417963|O1|Outcome|ViVexx Carotid Stent Group|placement of a bare metal stent for treatment of carotid artery stenosis
1157447|NCT00417963|E1|Reported Event|ViVexx Carotid Stent Group|placement of a bare metal stent for treatment of carotid artery stenosis
1157448|NCT00419003|B3|Baseline|Total|Total of all reporting groups
1157449|NCT00419003|B2|Baseline|Placebo Pre-Treatment|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth.
1157450|NCT00419003|B1|Baseline|Lamotrigine Pre-Treatment|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth.
1157451|NCT00419003|P2|Participant Flow|Placebo Pre-Treatment (Phase I)/Placebo (Phase II)|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth. All non responders were exited from the study. All responders (in both the lamotrigine and placebo pre-treatment groups were treated as one group and randomized into either treatment with riluzole or placebo for Phase II)
1157452|NCT00419003|P1|Participant Flow|Lamotrigine Pre-Treatment (Phase I)/Riluzole (Phase II)|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth. All non responders were exited from the study. All responders (in both the lamotrigine and placebo pre-treatment groups were treated as one group and randomized into either treatment with riluzole or placebo for Phase II)
1157453|NCT00419003|O2|Outcome|Placebo|Patients who responded (n=14) to the ketamine infusion (in either the lamotrigine or placebo pre-treatment groups) were randomized into phase II for treatment with either riluzole or placebo.
1157454|NCT00419003|O1|Outcome|Riluzole Group|Patients who responded (n=14) to the ketamine infusion (in either the lamotrigine or placebo pre-treatment groups) were randomized into phase II for treatment with either riluzole or placebo. One patient in the riluzole group was discontinued/withdrew consent before completing the study.
1157455|NCT00419003|E5|Reported Event|Placebo Pre-Treatment|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth.
1157456|NCT00419003|E4|Reported Event|Lamotrigine Pre-Treatment|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth.
1157457|NCT00419003|E3|Reported Event|Ketamine|IV infusion of 0.5 mg/kg of Ketamine Hydrochloride
1157458|NCT00419003|E2|Reported Event|Placebo|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth.
1157459|NCT00419003|E1|Reported Event|Riluzole Group|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth.
1157460|NCT00418977|B3|Baseline|Total|Total of all reporting groups
1157461|NCT00418977|B2|Baseline|Individual Supportive Psychotherapy|Participants received individual supportive psychotherapy (ISP)
1157462|NCT00418977|B1|Baseline|Family Based Therapy|Participants received family based therapy (FBT)
1157505|NCT00418938|B1|Baseline|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
1157506|NCT00418938|P2|Participant Flow|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
1157507|NCT00418938|P1|Participant Flow|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
1157463|NCT00418977|P2|Participant Flow|Individual Supportive Psychotherapy|"Participants received individual supportive psychotherapy (ISP)~Individual Supportive Psychotherapy: The goal of ISP is for the patient to understand and address the psychological issues underlying the origin and maintenance of the eating disorder. This work is done directly with the child/adolescent. In this treatment, eating disorders are seen as complicated (e.g., they tend to mask other underlying difficulties). In Phase I, the aims are to establish a sound therapeutic relationship, obtain a comprehensive description of the eating problem and its development, identify underlying problems that might be responsible for the disordered eating, and inform the patient about the dangers of eating disorders. Phase II encourages participants to explore underlying emotional problems, facilitates self-disclosure and expression of feelings, and fosters independence. Phase III focuses on how other underlying issues might affect future adjustment."
1157511|NCT00418938|O1|Outcome|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
1157558|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
1157464|NCT00418977|P1|Participant Flow|Family Based Therapy|"Participants received family based therapy (FBT)~Family-Based Therapy (Maudsley Method): The goal of FBT is to resolve the eating disorder and return the patient to healthy psychosocial and physiological development through active family involvement across three treatment phases. In Phase I, therapy is focused on the disordered eating. The therapist primarily makes careful, persistent requests for united parental action toward re-feeding and/or regulating eating habits and directs the discussion so as to create and reinforce a strong parental alliance around their efforts at feeding their child. In Phase II, the goal is to gradually transfer control over eating back to the participant, with the parents still maintaining general oversight and responsibility for continued progression toward healthy habits. In Phase III, the central goal is establishment of a healthy child or adolescent relationship with the parents where disordered eating is not the basis of interaction."
1157465|NCT00418977|O2|Outcome|Individual Supportive Psychotherapy|Participants received individual supportive psychotherapy (ISP)
1157466|NCT00418977|O1|Outcome|Family Based Therapy|Participants received family based therapy (FBT)
1157467|NCT00418977|O2|Outcome|Individual Supportive Psychotherapy|Participants received individual supportive psychotherapy (ISP)
1157468|NCT00418977|O1|Outcome|Family Based Therapy|Participants received family based therapy (FBT)
1157469|NCT00418977|O2|Outcome|Individual Supportive Psychotherapy|Participants received individual supportive psychotherapy (ISP)
1157470|NCT00418977|O1|Outcome|Family Based Therapy|Participants received family based therapy (FBT)
1157471|NCT00418977|O2|Outcome|Individual Supportive Psychotherapy|Participants received individual supportive psychotherapy (ISP)
1157472|NCT00418977|O1|Outcome|Family Based Therapy|Participants received family based therapy (FBT)
1157473|NCT00418977|O2|Outcome|Individual Supportive Psychotherapy|Participants received individual supportive psychotherapy (ISP)
1157474|NCT00418977|O1|Outcome|Family Based Therapy|Participants received family based therapy (FBT)
1157475|NCT00418977|E2|Reported Event|Individual Supportive Psychotherapy|Participants received individual supportive psychotherapy (ISP)
1157476|NCT00418977|E1|Reported Event|Family Based Therapy|Participants received family based therapy (FBT)
1157477|NCT00418964|B4|Baseline|Total|Total of all reporting groups
1157478|NCT00418964|B3|Baseline|BPTB|Bone Patellar Tendon Bone (Bone patellar tendon bone autograft in a single bone tunnel)
1157479|NCT00418964|B2|Baseline|HT-DB|Double bundle hamstring (hamstring autograft in two bone tunnels)
1157480|NCT00418964|B1|Baseline|HT-SB|Single bundle hamstring (hamstring autograft in a single bone tunnel)
1157481|NCT00418964|P3|Participant Flow|BPTB|Bone Patellar Tendon Bone (Bone patellar tendon bone autograft in a single bone tunnel)
1157482|NCT00418964|P2|Participant Flow|HT-DB|Double bundle hamstring (hamstring autograft in two bone tunnels)
1157483|NCT00418964|P1|Participant Flow|HT-SB|Single bundle hamstring (hamstring autograft in a single bone tunnel)
1157484|NCT00418964|O3|Outcome|BPTB|Bone Patellar Tendon Bone (Bone patellar tendon bone autograft in a single bone tunnel)
1157485|NCT00418964|O2|Outcome|HT-DB|Double bundle hamstring (hamstring autograft in two bone tunnels)
1157486|NCT00418964|O1|Outcome|HT-SB|Single bundle hamstring (hamstring autograft in a single bone tunnel)
1157487|NCT00418964|E3|Reported Event|BPTB|Bone Patellar Tendon Bone (Bone patellar tendon bone autograft in a single bone tunnel)
1157488|NCT00418964|E2|Reported Event|HT-DB|Double bundle hamstring (hamstring autograft in two bone tunnels)
1157489|NCT00418964|E1|Reported Event|HT-SB|Single bundle hamstring (hamstring autograft in a single bone tunnel)
1157490|NCT00418951|B4|Baseline|Total|Total of all reporting groups
1157491|NCT00418951|B3|Baseline|Voriconazole: 400 mg|400 mg oral twice daily day 1 followed by 200 mg twice daily
1157492|NCT00418951|B2|Baseline|Liposomal Amphotericin B: 9 mg/kg|9 mg/kg IV once per week
1157493|NCT00418951|B1|Baseline|Liposomal Amphotericin B: 3 mg/kg|3 mg/kg intravenously (IV) three times per week
1157494|NCT00418951|P3|Participant Flow|Voriconazole: 400 mg|400 mg oral twice daily day 1 followed by 200 mg twice daily
1157495|NCT00418951|P2|Participant Flow|Liposomal Amphotericin B: 9 mg/kg|9 mg/kg IV once per week
1157496|NCT00418951|P1|Participant Flow|Liposomal Amphotericin B: 3 mg/kg|3 mg/kg intravenously (IV) three times per week
1157497|NCT00418951|O3|Outcome|Voriconazole: 400 mg|400 mg oral twice daily day 1 followed by 200 mg twice daily
1157498|NCT00418951|O2|Outcome|Liposomal Amphotericin B: 9 mg/kg|9 mg/kg IV once per week
1157499|NCT00418951|O1|Outcome|Liposomal Amphotericin B: 3 mg/kg|3 mg/kg intravenously (IV) three times per week
1157500|NCT00418951|E3|Reported Event|Voriconazole: 400 mg|400 mg oral twice daily day 1 followed by 200 mg twice daily
1157501|NCT00418951|E2|Reported Event|Liposomal Amphotericin B: 9 mg/kg|9 mg/kg IV once per week
1157502|NCT00418951|E1|Reported Event|Liposomal Amphotericin B: 3 mg/kg|3 mg/kg intravenously (IV) three times per week
1157503|NCT00418938|B3|Baseline|Total|Total of all reporting groups
1157504|NCT00418938|B2|Baseline|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
1157508|NCT00418938|O2|Outcome|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
1157509|NCT00418938|O1|Outcome|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
1157510|NCT00418938|O2|Outcome|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
1157512|NCT00418938|O2|Outcome|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
1157513|NCT00418938|O1|Outcome|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
1157514|NCT00418938|O2|Outcome|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
1157515|NCT00418938|O1|Outcome|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
1157516|NCT00418938|O2|Outcome|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
1157517|NCT00418938|O1|Outcome|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
1157518|NCT00418938|O2|Outcome|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
1157519|NCT00418938|O1|Outcome|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
1157520|NCT00418938|O2|Outcome|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
1157521|NCT00418938|O1|Outcome|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
1157522|NCT00418938|E2|Reported Event|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
1157523|NCT00418938|E1|Reported Event|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
1157524|NCT00418886|B3|Baseline|Total|Total of all reporting groups
1157525|NCT00418886|B2|Baseline|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
1157526|NCT00418886|B1|Baseline|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
1157527|NCT00418886|P2|Participant Flow|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
1157528|NCT00418886|P1|Participant Flow|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
1157529|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
1157530|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
1157531|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
1157532|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
1157533|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
1157534|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
1157535|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
1157536|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
1157537|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
1157538|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
1157539|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
1157540|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
1157541|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
1157542|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
1157543|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
1157544|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
1157545|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
1157546|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
1157547|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
1157548|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
1157549|NCT00418886|E2|Reported Event|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
1157550|NCT00418886|E1|Reported Event|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
1157551|NCT00418834|B3|Baseline|Total|Total of all reporting groups
1157552|NCT00418834|B2|Baseline|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
1157554|NCT00418834|P2|Participant Flow|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
1157555|NCT00418834|P1|Participant Flow|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
1157556|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
1157559|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
1157560|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
1157561|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
1157562|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
1157563|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
1157564|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
1157565|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
1157566|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
1157567|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
1157568|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
1157569|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
1157570|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
1157571|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
1157572|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
1157573|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
1157574|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
1157575|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
1157576|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
1157577|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
1157578|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
1157579|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
1157580|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
1157581|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
1157582|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
1157583|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
1157584|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
1157585|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
1157586|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
1157587|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
1157588|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
1157589|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
1157590|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
1157591|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
1157592|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
1157593|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
1157594|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
1157595|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
1157596|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
1157597|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
1157598|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
1157599|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
1157600|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
1157601|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
1157602|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
1157603|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
1157604|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
1157605|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
1163374|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1157606|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
1157607|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
1157608|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
1157609|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
1157610|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
1157611|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
1157612|NCT00418834|E2|Reported Event|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
1157613|NCT00418834|E1|Reported Event|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
1157614|NCT00418717|B1|Baseline|Etanercept (ETN)|"Weeks 1-4 (Treatment period A): Etanercept 25 mg bi-weekly (BW)~Weeks 5-12 (Treatment period B): Etanercept 50mg once weekly (QW)"
1157615|NCT00418717|P1|Participant Flow|Etanercept (ETN)|"Weeks 1-4 (Treatment period A): Etanercept 25 mg bi-weekly (BW)~Weeks 5-12 (Treatment period B): Etanercept 50mg once weekly (QW)"
1157616|NCT00418717|O1|Outcome|Etanercept (ETN)|"Weeks 1-4 (Treatment period A): Etanercept 25 mg bi-weekly (BW)~Weeks 5-12 (Treatment period B): Etanercept 50mg once weekly (QW)"
1157617|NCT00418717|O1|Outcome|Etanercept (ETN)|"Weeks 1-4 (Treatment period A): Etanercept 25 mg bi-weekly (BW)~Weeks 5-12 (Treatment period B): Etanercept 50mg once weekly (QW)"
1157618|NCT00418717|E1|Reported Event|Etanercept (ETN)|"Weeks 1-4 (Treatment period A): Etanercept 25 mg bi-weekly (BW)~Weeks 5-12 (Treatment period B): Etanercept 50mg once weekly (QW)"
1157619|NCT00418691|B4|Baseline|Total|Total of all reporting groups
1157620|NCT00418691|B3|Baseline|Modafinil|18 mg PO once daily for 4 weeks
1157621|NCT00418691|B2|Baseline|SR Methylphenidate|Sustained Release (SR) Methylphenidate 200 mg PO once daily for 4 weeks
1157622|NCT00418691|B1|Baseline|IR Methylphenidate|Immediate Release (IR) Methylphenidate 10 mg by mouth (PO) twice daily for 4 weeks
1157623|NCT00418691|P3|Participant Flow|Modafinil|18 mg PO once daily for 4 weeks
1157624|NCT00418691|P2|Participant Flow|SR Methylphenidate|Sustained Release (SR) Methylphenidate 200 mg PO once daily for 4 weeks
1157625|NCT00418691|P1|Participant Flow|IR Methylphenidate|Immediate Release (IR) Methylphenidate 10 mg by mouth (PO) twice daily for 4 weeks
1157626|NCT00418691|O3|Outcome|Modafinil|18 mg PO once daily for 4 weeks
1157627|NCT00418691|O2|Outcome|SR Methylphenidate|Sustained Release (SR) Methylphenidate 200 mg PO once daily for 4 weeks
1157628|NCT00418691|O1|Outcome|IR Methylphenidate|Immediate Release (IR) Methylphenidate 10 mg by mouth (PO) twice daily for 4 weeks
1157629|NCT00418691|E3|Reported Event|Modafinil|18 mg PO once daily for 4 weeks
1157630|NCT00418691|E2|Reported Event|SR Methylphenidate|Sustained Release (SR) Methylphenidate 200 mg PO once daily for 4 weeks
1157631|NCT00418691|E1|Reported Event|IR Methylphenidate|Immediate Release (IR) Methylphenidate 10 mg by mouth (PO) twice daily for 4 weeks
1157632|NCT00418665|B4|Baseline|Total|Total of all reporting groups
1157633|NCT00418665|B3|Baseline|Romiplostim 750 μg|Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
1157634|NCT00418665|B2|Baseline|Romiplostim 500 μg|Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
1157635|NCT00418665|B1|Baseline|Placebo|Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
1157636|NCT00418665|P3|Participant Flow|Romiplostim (AMG 531) 750 μg|Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
1157637|NCT00418665|P2|Participant Flow|Romiplostim (AMG 531) 500 μg|Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
1157638|NCT00418665|P1|Participant Flow|Placebo|Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
1157639|NCT00418665|O3|Outcome|Romiplostim 750 μg|Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
1157640|NCT00418665|O2|Outcome|Romiplostim 500 μg|Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
1157641|NCT00418665|O1|Outcome|Placebo|Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
1157642|NCT00418665|O3|Outcome|Romiplostim 750 μg|Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
1157643|NCT00418665|O2|Outcome|Romiplostim 500 μg|Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
1157644|NCT00418665|O1|Outcome|Placebo|Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
1157645|NCT00418665|O3|Outcome|Romiplostim 750 μg|Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
1157646|NCT00418665|O2|Outcome|Romiplostim 500 μg|Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
1157647|NCT00418665|O1|Outcome|Placebo|Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
1157648|NCT00418665|O3|Outcome|Romiplostim 750 μg|Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
1157649|NCT00418665|O2|Outcome|Romiplostim 500 μg|Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
1157650|NCT00418665|O1|Outcome|Placebo|Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
1157651|NCT00418665|E3|Reported Event|Romiplostim 750 µg|
1157652|NCT00418665|E2|Reported Event|Romiplostim 500 µg|
1157653|NCT00418665|E1|Reported Event|Placebo|
1157654|NCT00418574|B3|Baseline|Total|Total of all reporting groups
1163375|NCT00402987|O4|Outcome|Placebo|
1157655|NCT00418574|B2|Baseline|Placebo|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
1157656|NCT00418574|B1|Baseline|Abagovomab|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
1157657|NCT00418574|P2|Participant Flow|Placebo|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
1157658|NCT00418574|P1|Participant Flow|Abagovomab|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
1157659|NCT00418574|O1|Outcome|Abagovomab|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
1157660|NCT00418574|O2|Outcome|Placebo|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
1157661|NCT00418574|O1|Outcome|Abagovomab|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
1157662|NCT00418574|O2|Outcome|Placebo|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
1157663|NCT00418574|O1|Outcome|Abagovomab|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
1157664|NCT00418574|O2|Outcome|Placebo|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
1157665|NCT00418574|O1|Outcome|Abagovomab|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
1157666|NCT00418574|E2|Reported Event|Placebo|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
1157667|NCT00418574|E1|Reported Event|Abagovomab|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
1157668|NCT00418561|B4|Baseline|Total|Total of all reporting groups
1157669|NCT00418561|B3|Baseline|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157670|NCT00418561|B2|Baseline|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157671|NCT00418561|B1|Baseline|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157672|NCT00418561|P3|Participant Flow|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157673|NCT00418561|P2|Participant Flow|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157674|NCT00418561|P1|Participant Flow|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157675|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157676|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157677|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157678|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157679|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157680|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157681|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157682|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157683|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157684|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157762|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
1157685|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157686|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157687|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157688|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157689|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157690|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157691|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157692|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157693|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157694|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157695|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157696|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157697|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157698|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157699|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157700|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157701|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157702|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157703|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157704|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157705|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157706|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1158716|NCT00414167|P2|Participant Flow|Placebo|"Placebo~Placebo : Placebo"
1157707|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157708|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157709|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157710|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157711|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157712|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157713|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157714|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157715|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157716|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157717|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157718|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157719|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157720|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157721|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157722|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157723|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157724|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157725|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157726|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157727|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157728|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157729|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157730|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157731|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157732|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157733|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157734|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157735|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157736|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157737|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157738|NCT00418561|E3|Reported Event|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157739|NCT00418561|E2|Reported Event|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157740|NCT00418561|E1|Reported Event|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
1157741|NCT00418522|B3|Baseline|Total|Total of all reporting groups
1157742|NCT00418522|B2|Baseline|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
1157743|NCT00418522|B1|Baseline|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
1157744|NCT00418522|P2|Participant Flow|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
1157745|NCT00418522|P1|Participant Flow|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
1157746|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
1157747|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
1157748|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
1157749|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
1157750|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
1157751|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
1157752|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
1157753|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
1157754|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
1157755|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
1157756|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
1157757|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
1157758|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
1157759|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
1157760|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
1157761|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
1157801|NCT00418314|B3|Baseline|Total|Total of all reporting groups
1157802|NCT00418314|B2|Baseline|Control|Empiric programming or one-time optimization using a non-IEGM method.
1157763|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
1157764|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
1157765|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
1157766|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
1157767|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
1157768|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
1157769|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
1157770|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
1157771|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
1157772|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
1157773|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
1157774|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
1157775|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
1157776|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
1157777|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
1157778|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
1157779|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
1157780|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
1157781|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
1157782|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
1157783|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
1157784|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
1157785|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
1157786|NCT00418522|E2|Reported Event|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
1157787|NCT00418522|E1|Reported Event|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
1157788|NCT00418379|B4|Baseline|Total|Total of all reporting groups
1157789|NCT00418379|B3|Baseline|Placebo|Placebo tablet
1157790|NCT00418379|B2|Baseline|300 IR (2M)|300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season
1157791|NCT00418379|B1|Baseline|300 IR (4M)|300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season
1157792|NCT00418379|P3|Participant Flow|Placebo|Placebo tablet
1157793|NCT00418379|P2|Participant Flow|300 IR (2M)|300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season
1157794|NCT00418379|P1|Participant Flow|300 IR (4M)|300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season
1157795|NCT00418379|O3|Outcome|Placebo|Placebo tablet
1157796|NCT00418379|O2|Outcome|300 IR (2M)|300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season
1157797|NCT00418379|O1|Outcome|300 IR (4M)|300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season
1157798|NCT00418379|E3|Reported Event|Placebo|Placebo tablet
1157799|NCT00418379|E2|Reported Event|300 IR (2M)|300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season
1157800|NCT00418379|E1|Reported Event|300 IR (4M)|300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season
1157803|NCT00418314|B1|Baseline|QuickOpt (Treatment)|Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
1157804|NCT00418314|P2|Participant Flow|Control|Empiric programming or one-time optimization using a non-IEGM method.
1157805|NCT00418314|P1|Participant Flow|QuickOpt (Treatment)|Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
1157806|NCT00418314|O2|Outcome|Control|Empiric programming or one-time optimization using a non-IEGM method.
1157807|NCT00418314|O1|Outcome|QuickOpt (Treatment)|Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
1157808|NCT00418314|O2|Outcome|Control|Empiric programming or one-time optimization using a non-IEGM method.
1157809|NCT00418314|O1|Outcome|QuickOpt (Treatment)|Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
1157810|NCT00418314|O2|Outcome|Control|Empiric programming or one-time optimization using a non-IEGM method.
1157811|NCT00418314|O1|Outcome|QuickOpt (Treatment)|Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
1157812|NCT00418314|E2|Reported Event|Control|Empiric programming or one-time optimization using a non-IEGM method.
1157813|NCT00418314|E1|Reported Event|QuickOpt (Treatment)|Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
1157814|NCT00418184|B3|Baseline|Total|Total of all reporting groups
1157815|NCT00418184|B2|Baseline|Placebo|Double-blind: Cellulose (4 capsules per day). Open-label: PS-omega3
1157816|NCT00418184|B1|Baseline|PS Omega 3 Conjugate|The daily dosage consisted of 4 capsules of PS-Omega3, providing 300 mg Phosphatidylserine per day.
1157817|NCT00418184|P2|Participant Flow|Placebo|Double-blind: Cellulose (4 capsules per day). Open-label: PS-omega3
1157818|NCT00418184|P1|Participant Flow|PS Omega 3 Conjugate|The daily dosage consisted of 4 capsules of PS-Omega3, providing 300 mg Phosphatidylserine per day.
1157819|NCT00418184|O2|Outcome|Placebo|Double-blind: Cellulose (4 capsules per day). Open-label: PS-omega3
1157820|NCT00418184|O1|Outcome|PS Omega 3 Conjugate|The daily dosage consisted of 4 capsules of PS-Omega3, providing 300 mg Phosphatidylserine per day.
1157821|NCT00418184|O2|Outcome|Placebo|Double-blind: Cellulose (4 capsules per day). Open-label: PS-omega3
1157822|NCT00418184|O1|Outcome|PS Omega 3 Conjugate|The daily dosage consisted of 4 capsules of PS-Omega3, providing 300 mg Phosphatidylserine per day.
1157823|NCT00418184|E2|Reported Event|Placebo|Double-blind: Cellulose (4 capsules per day). Open-label: PS-omega3
1157824|NCT00418184|E1|Reported Event|PS Omega 3 Conjugate|The daily dosage consisted of 4 capsules of PS-Omega3, providing 300 mg Phosphatidylserine per day.
1157825|NCT00418145|B1|Baseline|Total Study Participants|Overall study participants - Data not available separated by arm. Data is also no longer accessible. Data was with biostatistician who no longer has data.
1157826|NCT00418145|P1|Participant Flow|Total Study Participants|Overall study participants. Data not available separated by arm. Data is also no longer accessible. Data was with biostatistician who no longer has data.
1157827|NCT00418145|O2|Outcome|IV Methylprednisolone|"1000 mg/qd/5 days~IV methylprednisolone: 1000 mg/qd/5 days"
1157828|NCT00418145|O1|Outcome|Megadose Oral Methylprednisolone|"1400 mg qd/5 days~megadose oral methylprednisolone: 1400 mg qd/5 days"
1157829|NCT00418145|O2|Outcome|IV Methylprednisolone|"1000 mg/qd/5 days~IV methylprednisolone: 1000 mg/qd/5 days"
1157830|NCT00418145|O1|Outcome|Megadose Oral Methylprednisolone|"1400 mg qd/5 days~megadose oral methylprednisolone: 1400 mg qd/5 days"
1157831|NCT00418145|O2|Outcome|IV Methylprednisolone|"1000 mg/qd/5 days~IV methylprednisolone: 1000 mg/qd/5 days"
1157832|NCT00418145|O1|Outcome|Megadose Oral Methylprednisolone|"1400 mg qd/5 days~megadose oral methylprednisolone: 1400 mg qd/5 days"
1157833|NCT00418145|O2|Outcome|IV Methylprednisolone|"1000 mg/qd/5 days~IV methylprednisolone: 1000 mg/qd/5 days"
1157834|NCT00418145|O1|Outcome|Megadose Oral Methylprednisolone|"1400 mg qd/5 days~megadose oral methylprednisolone: 1400 mg qd/5 days"
1157835|NCT00418145|E2|Reported Event|IV Methylprednisolone|"1000 mg/qd/5 days~IV methylprednisolone: 1000 mg/qd/5 days"
1157836|NCT00418145|E1|Reported Event|Megadose Oral Methylprednisolone|"1400 mg qd/5 days~megadose oral methylprednisolone: 1400 mg qd/5 days"
1157837|NCT00418093|B1|Baseline|Group 1|
1157838|NCT00418093|P1|Participant Flow|Chemotherapy Group|Oxaliplatin plus Gemcitabine plus Bevacizumab
1157839|NCT00418093|O1|Outcome|Chemotherapy Group|Oxaliplatin, Gemcitabine, Bevacizumab
1157840|NCT00418093|O1|Outcome|Chemotherapy Group|Oxaliplatin, Gemcitabine, Bevacizumab
1157841|NCT00418093|O1|Outcome|Chemotherapy Group|Oxaliplatin, Gemcitabine, Bevacizumab
1157842|NCT00418093|O1|Outcome|Chemotherapy Group|Oxaliplatin, Gemcitabine, Bevacizumab
1157843|NCT00418093|E1|Reported Event|Group 1|
1157844|NCT00418015|B5|Baseline|Total|Total of all reporting groups
1157845|NCT00418015|B4|Baseline|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
1157846|NCT00418015|B3|Baseline|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
1157847|NCT00418015|B2|Baseline|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
1157848|NCT00418015|B1|Baseline|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
1157885|NCT00417989|O1|Outcome|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
1157849|NCT00418015|P4|Participant Flow|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
1157850|NCT00418015|P3|Participant Flow|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
1157851|NCT00418015|P2|Participant Flow|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
1157852|NCT00418015|P1|Participant Flow|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
1157853|NCT00418015|O4|Outcome|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
1157854|NCT00418015|O3|Outcome|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
1157855|NCT00418015|O2|Outcome|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
1157856|NCT00418015|O1|Outcome|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
1157857|NCT00418015|O4|Outcome|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
1157858|NCT00418015|O3|Outcome|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
1157859|NCT00418015|O2|Outcome|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
1157860|NCT00418015|O1|Outcome|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
1157861|NCT00418015|O4|Outcome|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
1157862|NCT00418015|O3|Outcome|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
1157863|NCT00418015|O2|Outcome|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
1157864|NCT00418015|O1|Outcome|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
1157865|NCT00418015|O4|Outcome|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
1157866|NCT00418015|O3|Outcome|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
1157867|NCT00418015|O2|Outcome|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
1157868|NCT00418015|O1|Outcome|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
1157869|NCT00418015|O4|Outcome|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
1157870|NCT00418015|O3|Outcome|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
1157871|NCT00418015|O2|Outcome|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
1157872|NCT00418015|O1|Outcome|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
1157873|NCT00418015|E4|Reported Event|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
1157874|NCT00418015|E3|Reported Event|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
1157875|NCT00418015|E2|Reported Event|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
1157876|NCT00418015|E1|Reported Event|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
1157877|NCT00417989|B3|Baseline|Total|Total of all reporting groups
1157878|NCT00417989|B2|Baseline|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
1157879|NCT00417989|B1|Baseline|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
1157880|NCT00417989|P2|Participant Flow|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
1157881|NCT00417989|P1|Participant Flow|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
1157882|NCT00417989|O2|Outcome|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
1157883|NCT00417989|O1|Outcome|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
1157884|NCT00417989|O2|Outcome|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
1158828|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
1157886|NCT00417989|O2|Outcome|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
1157887|NCT00417989|O1|Outcome|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
1157888|NCT00417989|O2|Outcome|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
1157889|NCT00417989|O1|Outcome|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
1157890|NCT00417989|O2|Outcome|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
1158393|NCT00415051|O1|Outcome|Single Group Assignment|"RVF MP-12~RVF MP-12: Administer 1 ml SQ"
1157891|NCT00417989|O1|Outcome|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
1157892|NCT00417989|O2|Outcome|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
1157893|NCT00417989|O1|Outcome|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
1157894|NCT00417989|O2|Outcome|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
1157895|NCT00417989|O1|Outcome|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
1157896|NCT00417989|O2|Outcome|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
1157897|NCT00417989|O1|Outcome|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
1157898|NCT00417989|E2|Reported Event|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
1157899|NCT00417989|E1|Reported Event|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
1157900|NCT00417885|B1|Baseline|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
1157901|NCT00417885|P1|Participant Flow|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
1157902|NCT00417885|O1|Outcome|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
1157903|NCT00417885|O1|Outcome|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
1157904|NCT00417885|O1|Outcome|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
1157905|NCT00417885|O1|Outcome|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
1157906|NCT00417885|O1|Outcome|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
1157907|NCT00417885|O1|Outcome|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
1157908|NCT00417885|E1|Reported Event|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
1157909|NCT00417612|B3|Baseline|Total|Total of all reporting groups
1157910|NCT00417612|B2|Baseline|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
1157911|NCT00417612|B1|Baseline|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
1157912|NCT00417612|P2|Participant Flow|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
1157913|NCT00417612|P1|Participant Flow|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce Parathyroid Hormone (PTH) level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
1157914|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
1157915|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
1157916|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
1157917|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce parathyroid hormone (PTH) level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
1157918|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
1157919|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
1157920|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
1157921|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
1157922|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
1157923|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
1158829|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
1157924|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
1157925|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
1157926|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
1157927|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
1158394|NCT00415051|E1|Reported Event|Single Group Assignment|"RVF MP-12~RVF MP-12: Administer 1 ml SQ"
1157928|NCT00417612|O3|Outcome|Paricalcitol (Children Ages 9-17)|Pediatric patients ages 9-17 given paricalcitol
1157929|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
1157930|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
1157931|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
1157932|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
1157933|NCT00417612|E2|Reported Event|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
1157934|NCT00417612|E1|Reported Event|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
1157935|NCT00417482|B4|Baseline|Total|Total of all reporting groups
1157936|NCT00417482|B3|Baseline|Phase B Arm 3: Placebo-Placebo|Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3). For patients receiving risperidone ≥ 2 mg daily at end-Phase A, assignment to placebo in Phase B required an initial one-week taper with sequential double-blind placebo substitution (e.g., one 2 mg tablet switched to one 1 mg tablet and then to one placebo tablet) to reduce antipsychotic physical withdrawal effects.
1157937|NCT00417482|B2|Baseline|Phase B Arm 2: Risperidone -Placebo|Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3). For patients receiving risperidone ≥ 2 mg daily at end-Phase A, assignment to placebo in Phase B required an initial one-week taper with sequential double-blind placebo substitution (e.g., one 2 mg tablet switched to one 1 mg tablet and then to one placebo tablet) to reduce antipsychotic physical withdrawal effects.
1157938|NCT00417482|B1|Baseline|Phase B Arm 1: Risperidone-Risperidone|Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3). For patients receiving risperidone ≥ 2 mg daily at end-Phase A, assignment to placebo in Phase B required an initial one-week taper with sequential double-blind placebo substitution (e.g., one 2 mg tablet switched to one 1 mg tablet and then to one placebo tablet) to reduce antipsychotic physical withdrawal effects.
1157939|NCT00417482|P3|Participant Flow|Phase B Arm 3: Placebo-Placebo|"Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3).~Phase B Arm 3: Patients were randomized to placebo for 32 weeks."
1157940|NCT00417482|P2|Participant Flow|Phase B Arm 2: Risperidone-Placebo|"Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3).~Phase B Arm 2: Risperidone for 16 weeks followed by placebo for 16 weeks;"
1157941|NCT00417482|P1|Participant Flow|Arm 1: Risperidone-Risperidone|"Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3).~Phase B Arm 1: Risperidone for 16 weeks followed by risperidone for 16 weeks; Risperidone open label flexible dose was administered at a dose of 0.25 to 3 mg daily for first 16 weeks; dose at 16 weeks then fixed for the randomized trial"
1157942|NCT00417482|O2|Outcome|Risperidone|Subjects in Arm 1 and Arm 2, as described above. Subjects in these two arms received risperidone for the first 16 weeks of Phase B, and were combined for purposes of this secondary analysis.
1157943|NCT00417482|O1|Outcome|Placebo|Subjects assigned to Arm 3, as described above
1157944|NCT00417482|O2|Outcome|Risperidone|Subjects in Arm 1 and Arm 2, as described above. Subjects in these two arms received risperidone for the first 16 weeks of Phase B, and were combined for purposes of this secondary analysis.
1157945|NCT00417482|O1|Outcome|Placebo|Subjects assigned to Arm 3, as described above
1157946|NCT00417482|O2|Outcome|Risperidone|Subjects in Arm 1 and Arm 2, as described above. Subjects in these two arms received risperidone for the first 16 weeks of Phase B, and were combined for purposes of this secondary analysis.
1157947|NCT00417482|O1|Outcome|Placebo|Subjects assigned to Arm 3, as described above
1158021|NCT00417079|O1|Outcome|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
1157948|NCT00417482|O2|Outcome|Risperidone|Subjects in Arm 1 and Arm 2, as described above. Subjects in these two arms received risperidone for the first 16 weeks of Phase B, and were combined for purposes of this secondary analysis.
1157949|NCT00417482|O1|Outcome|Placebo|Subjects assigned to Arm 3, as described above
1157950|NCT00417482|O2|Outcome|Risperidone|Subjects in Arm 1 and Arm 2, as described above. Subjects in these two arms received risperidone for the first 16 weeks of Phase B, and were combined for purposes of this secondary analysis.
1157951|NCT00417482|O1|Outcome|Placebo|Subjects assigned to Arm 3, as described above
1157952|NCT00417482|O2|Outcome|Risperidone|Subjects in Arm 1 and Arm 2, as described above. Subjects in these two arms received risperidone for the first 16 weeks of Phase B, and were combined for purposes of this secondary analysis.
1157953|NCT00417482|O1|Outcome|Placebo|Subjects assigned to Arm 3, as described above
1158395|NCT00414973|B5|Baseline|Total|Total of all reporting groups
1157954|NCT00417482|O2|Outcome|Arm 2: Risperidone - Placebo|Subjects in Arm 2 who did not relapse or terminate from the study in the first 16 weeks of Phase B received placebo in the second 16 weeks of Phase B.
1157955|NCT00417482|O1|Outcome|Arm 1: Risperidone - Risperidone|Subjects in Arm 1 who did not relapse or terminate from the study in the first 16 weeks of Phase B continued to receive risperidone in the second 16 weeks of Phase B.
1157956|NCT00417482|O3|Outcome|Phase B Arm 3: Placebo-Placebo|"40 patients randomized to Phase B Arm 3 received placebo for 32 weeks. For patients receiving risperidone ≥ 2 mg daily at end-Phase A, assignment to placebo in Phase B required an initial one-week taper with sequential double-blind placebo substitution (e.g., one 2 mg tablet switched to one 1 mg tablet and then to one placebo tablet) to reduce antipsychotic physical withdrawal effects.~In Phase B, relapse required ≥ 30% increase or 5-point increase in NPI core scores from end-Phase A and a score of 6 (much worse) or 7 (very much worse) on the CGI-C."
1157957|NCT00417482|O2|Outcome|Phase B Arm 2: Risperidone -Placebo|"38 patients randomized to Phase B Arm 2 received risperidone therapy for 16 weeks followed by placebo for 16 weeks.~In Phase B, relapse required ≥ 30% increase or 5-point increase in NPI core scores from end-Phase A and a score of 6 (much worse) or 7 (very much worse) on the CGI-C."
1157958|NCT00417482|O1|Outcome|Phase B Arm 1: Risperidone-Risperidone|32 patients randomized to Phase B Arm 1 received continuation risperidone for another 32 weeks.
1157959|NCT00417482|E5|Reported Event|Wek 17-32 Phase B Arm 3: Placebo -Placebo|13 patients completed Week 0-16 of Phase B Arm 3 and entered Week 17-32 were they were given placebo for another 16 weeks.
1157960|NCT00417482|E4|Reported Event|Wk 17-32 Phase B Arm 2: Risperdone-Placebo|27 patients completed Wk 0-16 of Phase B Arm 2 and entered Week 17-32 of Phase B Arm 2 where they receive placebo for 16 weeks.
1157961|NCT00417482|E3|Reported Event|Wk 17-32 Phase B Arm 1: Risperdone-Risperdone|13 patients completed Wk 0-16 of Phase 2 Arm 1 and entered Wk 17-32 where they received risperidone for another 16 weeks.
1157962|NCT00417482|E2|Reported Event|Wk 0-16 Phase B Arm 3: Placebo -Placebo|40 patients randomized to Phase B Arm 3 received placebo for 32 weeks.
1157963|NCT00417482|E1|Reported Event|Wk0-16 Phase B Arm 1 (Risp-Risp) & Arm 2 (Risp-Pla)|32 patients randomized to Phase B Arm 1 received continuation risperidone for another 32 weeks; 38 patients randomized to Phase B Arm 2 received risperidone for 16 weeks followed by placebo for 16 weeks. Therefore there were a total of 70 patients in this group.
1157964|NCT00417417|B3|Baseline|Total|Total of all reporting groups
1157965|NCT00417417|B2|Baseline|Placebo|placebo injected every two weeks for two months
1157966|NCT00417417|B1|Baseline|Rilonacept|rilonacept 320 mg injected every 2 weeks x4 administrations.
1157967|NCT00417417|P2|Participant Flow|Placebo|placebo injected every two weeks x 4 administrations
1157968|NCT00417417|P1|Participant Flow|Rilonacept|rilonacept 320 mg injected every 2 weeks x4 administrations.
1157969|NCT00417417|O2|Outcome|Placebo|Placebo subcutaneous injection x 4 over 8 weeks
1157970|NCT00417417|O1|Outcome|Rilonacept|Rilonacept 320 mg subcutaneously x4 over 8 weeks
1157971|NCT00417417|O2|Outcome|Placebo|Placebo x 4 injections over 8 weeks
1157972|NCT00417417|O1|Outcome|Rilonacept|rilonacept 320 mg x 4 administrations over 8 weeks.
1157973|NCT00417417|E2|Reported Event|Placebo|placebo injected every two weeks for two months
1157974|NCT00417417|E1|Reported Event|Rilonacept|rilonacept 320 mg injected every 2 weeks x4 administrations.
1157975|NCT00417274|B1|Baseline|Quinacrine Treatment|Uncontrolled treatment arm
1157976|NCT00417274|P1|Participant Flow|Quinacrine Treatment|100 mg once a day
1157977|NCT00417274|O1|Outcome|Quinacrine Treatment|100 mg once a day
1157978|NCT00417274|E1|Reported Event|Quinacrine Treatment|Uncontrolled treatment arm
1157979|NCT00417248|B1|Baseline|Cisplatin/Etoposide/Radiotherapy Followed by Sorafenib|"Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer~Cisplatin: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle~Etoposide: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle~Radiotherapy: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)~Sorafenib: Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months"
1157980|NCT00417248|P1|Participant Flow|Cisplatin/Etoposide/Radiotherapy Followed by Sorafenib|"Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer~Cisplatin: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle~Etoposide: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle~Radiotherapy: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)~Sorafenib: Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months"
1157981|NCT00417248|O1|Outcome|Investigational Treatment|"Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer~Cisplatin: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle~Etoposide: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle~Radiotherapy: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)~Sorafenib: Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months"
1157982|NCT00417248|O1|Outcome|Cisplatin/Etoposide/Radiotherapy Followed by Sorafenib|"Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer~Cisplatin: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle~Etoposide: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle~Radiotherapy: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)~Sorafenib: Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months"
1158026|NCT00417027|B2|Baseline|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
1158396|NCT00414973|B4|Baseline|Calcitonin - Males|Intranasal, 200 IU/day, 24 weeks
1163376|NCT00402987|O3|Outcome|Celecoxib 100mg / 50mg|
1157983|NCT00417248|E1|Reported Event|Cisplatin/Etoposide/Radiotherapy Followed by Sorafenib|"Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer~Cisplatin: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle~Etoposide: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle~Radiotherapy: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)~Sorafenib: Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months"
1157984|NCT00417170|B3|Baseline|Total|Total of all reporting groups
1157985|NCT00417170|B2|Baseline|Amlodipine 5 mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
1157986|NCT00417170|B1|Baseline|Aliskiren 300 mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
1157987|NCT00417170|P2|Participant Flow|Amlodipine 5 mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
1157988|NCT00417170|P1|Participant Flow|Aliskiren 300 mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
1157989|NCT00417170|O2|Outcome|Amlodipine 5 mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
1157990|NCT00417170|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
1157991|NCT00417170|O2|Outcome|Amlodipine 5 mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
1157992|NCT00417170|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
1157993|NCT00417170|O2|Outcome|Amlodipine 5 mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
1157994|NCT00417170|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
1157995|NCT00417170|O2|Outcome|Amlodipine 5 mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
1157996|NCT00417170|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
1157997|NCT00417170|O2|Outcome|Amlodipine 5 mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
1157998|NCT00417170|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
1157999|NCT00417170|E2|Reported Event|Amlodipine 5mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
1158000|NCT00417170|E1|Reported Event|Aliskiren 300mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
1158001|NCT00417079|B3|Baseline|Total|Total of all reporting groups
1158002|NCT00417079|B2|Baseline|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
1158003|NCT00417079|B1|Baseline|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
1158004|NCT00417079|P2|Participant Flow|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
1158005|NCT00417079|P1|Participant Flow|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
1158006|NCT00417079|O2|Outcome|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
1158007|NCT00417079|O1|Outcome|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
1158008|NCT00417079|O2|Outcome|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
1158009|NCT00417079|O1|Outcome|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
1158010|NCT00417079|O2|Outcome|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
1158011|NCT00417079|O1|Outcome|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
1158012|NCT00417079|O2|Outcome|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
1158013|NCT00417079|O1|Outcome|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
1158014|NCT00417079|O2|Outcome|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
1158015|NCT00417079|O1|Outcome|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
1158016|NCT00417079|O2|Outcome|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
1158017|NCT00417079|O1|Outcome|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
1158018|NCT00417079|O2|Outcome|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
1158019|NCT00417079|O1|Outcome|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
1158020|NCT00417079|O2|Outcome|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
1158022|NCT00417079|E2|Reported Event|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
1158023|NCT00417079|E1|Reported Event|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
1158024|NCT00417027|B4|Baseline|Total|Total of all reporting groups
1158025|NCT00417027|B3|Baseline|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
1158083|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
1158397|NCT00414973|B3|Baseline|Teriparatide - Males|Subcutaneous, 20 micrograms/day, 24 weeks
1158027|NCT00417027|B1|Baseline|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
1158028|NCT00417027|P3|Participant Flow|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
1158029|NCT00417027|P2|Participant Flow|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
1158030|NCT00417027|P1|Participant Flow|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
1158031|NCT00417027|O3|Outcome|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
1158032|NCT00417027|O2|Outcome|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
1158033|NCT00417027|O1|Outcome|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
1158034|NCT00417027|O3|Outcome|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
1158035|NCT00417027|O2|Outcome|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
1158036|NCT00417027|O1|Outcome|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
1158037|NCT00417027|O3|Outcome|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
1158038|NCT00417027|O2|Outcome|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
1158039|NCT00417027|O1|Outcome|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
1158040|NCT00417027|O3|Outcome|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
1158041|NCT00417027|O2|Outcome|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
1158042|NCT00417027|O1|Outcome|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
1158043|NCT00417027|O3|Outcome|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
1158044|NCT00417027|O2|Outcome|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
1158045|NCT00417027|O1|Outcome|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
1158046|NCT00417027|O3|Outcome|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
1158047|NCT00417027|O2|Outcome|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
1158048|NCT00417027|O1|Outcome|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
1158049|NCT00417027|O3|Outcome|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
1158050|NCT00417027|O2|Outcome|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
1158051|NCT00417027|O1|Outcome|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
1158052|NCT00417027|E3|Reported Event|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
1158053|NCT00417027|E2|Reported Event|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
1158054|NCT00417027|E1|Reported Event|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
1158055|NCT00416884|B1|Baseline|TBI, Campath, Fludarabine T-cell Deplete|(Campath) 30 mg on day -8 over 5-6 hours, Fludarabine 30 mg/m2 on day -4 through day -2, Total body irradiation single fraction 200 cGy at 7 cGy per minute on day 0., Stem cells will be T-cell depleted and given on day 0
1158056|NCT00416884|P1|Participant Flow|TBI, Campath, Fludarabine T-cell Deplete|(Campath) 30 mg on day -8 over 5-6 hours, Fludarabine 30 mg/m2 on day -4 through day -2, Total body irradiation single fraction 200 cGy at 7 cGy per minute on day 0., Stem cells will be T-cell depleted and given on day 0
1158057|NCT00416884|O1|Outcome|TBI, Campath, Fludarabine T-cell Deplete|(Campath) 30 mg on day -8 over 5-6 hours, Fludarabine 30 mg/m2 on day -4 through day -2, Total body irradiation single fraction 200 cGy at 7 cGy per minute on day 0., Stem cells will be T-cell depleted and given on day 0
1158058|NCT00416884|E1|Reported Event|TBI, Campath, Fludarabine T-cell Deplete|(Campath) 30 mg on day -8 over 5-6 hours, Fludarabine 30 mg/m2 on day -4 through day -2, Total body irradiation single fraction 200 cGy at 7 cGy per minute on day 0., Stem cells will be T-cell depleted and given on day 0
1158059|NCT00416793|B1|Baseline|Bortezomib + Carboplatin|Bortezomib 1.3 mg/m2 by vein (IV) on days 1, 4, 8 + 11; Carboplatin Area Under the Curve (AUC) of 5 IV over 30 minutes
1158060|NCT00416793|P1|Participant Flow|Bortezomib + Carboplatin|Bortezomib 1.3 mg/m2 by vein (IV) on days 1, 4, 8 + 11; Carboplatin Area Under the Curve (AUC) of 5 IV over 30 minutes
1158061|NCT00416793|O1|Outcome|Bortezomib + Carboplatin|Bortezomib 1.3 mg/m2 by vein (IV) on days 1, 4, 8 + 11; Carboplatin Area Under the Curve (AUC) of 5 IV over 30 minutes
1158062|NCT00416793|E1|Reported Event|Bortezomib + Carboplatin|Bortezomib 1.3 mg/m2 by vein (IV) on days 1, 4, 8 + 11; Carboplatin Area Under the Curve (AUC) of 5 IV over 30 minutes
1158063|NCT00416624|B5|Baseline|Total|Total of all reporting groups
1158064|NCT00416624|B4|Baseline|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
1158065|NCT00416624|B3|Baseline|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
1158066|NCT00416624|B2|Baseline|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
1158067|NCT00416624|B1|Baseline|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
1158068|NCT00416624|P4|Participant Flow|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
1158069|NCT00416624|P3|Participant Flow|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
1158070|NCT00416624|P2|Participant Flow|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
1158071|NCT00416624|P1|Participant Flow|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
1158072|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
1158073|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
1158074|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
1158075|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
1158076|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
1163301|NCT00402987|O2|Outcome|Celecoxib 100mg /Placebo|
1158077|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
1158078|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
1158079|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
1158080|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
1158081|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
1158082|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
1158084|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
1158085|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
1158086|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
1158087|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
1158088|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
1158089|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
1158090|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
1158091|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
1158092|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
1158093|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
1158094|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
1158095|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
1158096|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
1158097|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
1158098|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
1158099|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
1158100|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
1158101|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
1158102|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
1158103|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
1158104|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
1158105|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
1158106|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
1158107|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
1158108|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
1158109|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
1158110|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
1158111|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
1158112|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
1158113|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
1158114|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
1158115|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
1158116|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
1158117|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
1158118|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
1158119|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
1158274|NCT00415623|O1|Outcome|Baseline|After once daily administration of amlodipine 5 mg for 8 weeks in the screening period
1158120|NCT00416624|E4|Reported Event|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
1158121|NCT00416624|E3|Reported Event|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
1158122|NCT00416624|E2|Reported Event|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
1158123|NCT00416624|E1|Reported Event|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
1158124|NCT00416598|B1|Baseline|Decatibine Maintenance|Within 60-90 days after completion of intensification therapy, patients receive 20 mg/m^2 decitabine IV over 1 hour on days 1-5. Treatment repeats every 6 weeks for up to 8 courses.
1158245|NCT00415870|B2|Baseline|PACE: Intervention - SMS Messages and Lifestyle Counseling|
1158246|NCT00415870|B1|Baseline|Control: Enhanced Usual Care|
1158125|NCT00416598|P1|Participant Flow|Treatment (Chemotherapy, PBSC or Bone Marrow Transplantation)|"See Detailed Description:~Patients undergo induction therapy comprising cytarabine and daunorubicin hydrochloride. Patient with RD undergo second induction therapy comprising cytarabine, daunorubicin hydrochloride, and etoposide. Patients with CR and favorable cytogenetics who achieve CR receive intensification therapy comprising high-dose cytarabine. Patients with UC receive etoposide, high-dose cytarabine, G-CSF., and busulfan and proceed to PBSC or bone marrow transplantation. Patients with UC and unable to undergo transplantation receive etoposide, high-dose cytarabine, and G-CSF. Patients then receive decitabine as maintenance therapy."
1158126|NCT00416598|O1|Outcome|Decatibine Maintenance|Within 60-90 days after completion of intensification therapy, patients receive 20 mg/m^2 decitabine IV over 1 hour on days 1-5. Treatment repeats every 6 weeks for up to 8 courses.
1158127|NCT00416598|O1|Outcome|Decatibine Maintenance|Within 60-90 days after completion of intensification therapy, patients receive 20 mg/m^2 decitabine IV over 1 hour on days 1-5. Treatment repeats every 6 weeks for up to 8 courses.
1158128|NCT00416598|E1|Reported Event|Decatibine Maintenance|Within 60-90 days after completion of intensification therapy, patients receive 20 mg/m^2 decitabine IV over 1 hour on days 1-5. Treatment repeats every 6 weeks for up to 8 courses.
1158129|NCT00416572|B4|Baseline|Total|Total of all reporting groups
1158130|NCT00416572|B3|Baseline|Control Condition|Participants received care as usual.
1158131|NCT00416572|B2|Baseline|Nutrition Education Intervention|Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.
1158132|NCT00416572|B1|Baseline|Education Intervention|Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants’ uncertainty about their illness/treatment, to enhance coping in productive ways.
1158133|NCT00416572|P3|Participant Flow|Control Condition|Participants received care as usual.
1158134|NCT00416572|P2|Participant Flow|Nutrition Education Intervention|"Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.~The nutrition sessions were presented by a professional trained in nutritional science. Sessions included the presentation of information and guided discussion of related topics. The first session discussed information on choosing fruits, vegetables, and low-fat foods and incorporating them into a diet; the second session involved a demonstration of low-fat cooking methods; the third session provided information on the nutritional make-up of a healthy diet and how to shop for it; the last session included information on how to maintain a healthy, low-fat diet while eating out. Women were also asked to keep a four-day food diary, to focus them on their dietary intake and control over it."
1158135|NCT00416572|P1|Participant Flow|Education Intervention|"Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants’ uncertainty about their illness/treatment, to enhance coping in productive ways.~Sessions were led by two professionals with expertise in the topic. The sessions began a with presentation of informational material followed by guided discussion of related topics. The first session discussed what to say and not say to children about cancer; the second session discussed carrying on with life after the diagnosis of breast cancer, including strategies for managing stress and anxiety and developing meaning in life; the third session talked about how to maintain closeness with a partner and ways to talk about breast cancer; the last session focused on the effects of treatment on reproductive status, and the genetic bases of breast cancer. Participants were also given related booklets and brochures to take home to read."
1158136|NCT00416572|O3|Outcome|Control Condition|Participants received care as usual
1158137|NCT00416572|O2|Outcome|Nutrition Education Intervention|Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.
1158138|NCT00416572|O1|Outcome|Education Intervention|Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants’ uncertainty about their illness/treatment, to enhance coping in productive ways.
1158139|NCT00416572|O3|Outcome|Control Condition|Participants received care as usual
1158140|NCT00416572|O2|Outcome|Nutrition Education Intervention|Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.
1158141|NCT00416572|O1|Outcome|Education Intervention|Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants’ uncertainty about their illness/treatment, to enhance coping in productive ways.
1158142|NCT00416572|O3|Outcome|Control Condition|Participants received care as usual
1158267|NCT00415623|P2|Participant Flow|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
1158143|NCT00416572|O2|Outcome|Nutrition Education Intervention|Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.
1158144|NCT00416572|O1|Outcome|Education Intervention|Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants’ uncertainty about their illness/treatment, to enhance coping in productive ways.
1158145|NCT00416572|E3|Reported Event|Control Condition|Participants received care as usual.
1158146|NCT00416572|E2|Reported Event|Nutrition Education Intervention|Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.
1158281|NCT00415623|O2|Outcome|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
1158398|NCT00414973|B2|Baseline|Calcitonin - Females|Intranasal, 200 International Units (IU)/day, 24 weeks
1158147|NCT00416572|E1|Reported Event|Education Intervention|Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants’ uncertainty about their illness/treatment, to enhance coping in productive ways.
1158148|NCT00416520|B3|Baseline|Total|Total of all reporting groups
1158149|NCT00416520|B2|Baseline|Sevelamer (Open-label Period)|
1158150|NCT00416520|B1|Baseline|MCI-196 (Open-label Period)|
1158151|NCT00416520|P4|Participant Flow|Placebo (Placebo-controlled Withdrawal Period)|"dose level at the end of dose titration in the flexible dose period~There was a gap of 1 subject between STARTED and Overall Number of Baseline Participants One subject did not take any study medication and excluded from Baseline Participants."
1158152|NCT00416520|P3|Participant Flow|MCI-196 (Placebo-controlled Withdrawal Period)|dose level at the end of dose titration in the flexible dose period
1158153|NCT00416520|P2|Participant Flow|Sevelamer (Open-label Period)|"2.4, 4.8, 7.2, 9.6, or 12.0g/day as titrated~There was a gap of 2 subjects between STARTED and Overall Number of Baseline Participants.~Three subjects in Sevelamer group were randomised in error and did not take any study medication. These 3 subjects were excluded from Baseline Participants of Sevelamer group.~However, one subject (A) was randomised to receive MCI-196, but took sevelamer instead. This subject was counted as MCI-196 group for STARTED but counted as Sevelamer group for Baseline Participants."
1158154|NCT00416520|P1|Participant Flow|MCI-196 (Open-label Period)|"3, 6, 9, 12, or 15g/day as titrated~There was a gap of 3 subjects between STARTED and Overall Number of Baseline Participants.~Two subjects were randomised to receive MCI-196, but did not take study medication. These 2 subjects were excluded from Baseline Participants of MCI-196 group.~In addition, one subject (A) was randomised to receive MCI-196, but took sevelamer instead. This subject was counted as MCI-196 group for STARTED but counted as Sevelamer group for Baseline Participants."
1158155|NCT00416520|O2|Outcome|Sevelamer (Open-label Period)|2.4, 4.8, 7.2, 9.6, or 12.0g/day as titrated
1158156|NCT00416520|O1|Outcome|MCI-196 (Open-label Period)|3, 6, 9, 12, or 15g/day as titrated
1158157|NCT00416520|O2|Outcome|Placebo (Placebo-controlled Withdrawal Period)|dose level at the end of dose titration in the flexible dose period
1158158|NCT00416520|O1|Outcome|MCI-196 (Placebo-controlled Withdrawal Period)|dose level at the end of dose titration in the flexible dose period
1158159|NCT00416520|E4|Reported Event|Placebo (Placebo-Controlled Period)|dose level at the end of dose titration in the flexible dose period
1158160|NCT00416520|E3|Reported Event|MCI-196 (Placebo-Controlled Period)|dose level at the end of dose titration in the flexible dose period
1158161|NCT00416520|E2|Reported Event|Sevelamer (Open-label Period)|2.4, 4.8, 7.2, 9.6, or 12.0g/day as titrated
1158162|NCT00416520|E1|Reported Event|MCI-196 (Open-label Period)|3, 6, 9, 12, or 15g/day as titrated
1158163|NCT00416494|B3|Baseline|Total|Total of all reporting groups
1158164|NCT00416494|B2|Baseline|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
1158165|NCT00416494|B1|Baseline|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
1158166|NCT00416494|P2|Participant Flow|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
1158167|NCT00416494|P1|Participant Flow|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
1158168|NCT00416494|O2|Outcome|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
1158169|NCT00416494|O1|Outcome|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
1158170|NCT00416494|O2|Outcome|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
1158171|NCT00416494|O1|Outcome|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
1158172|NCT00416494|O2|Outcome|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
1158275|NCT00415623|O2|Outcome|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
1158173|NCT00416494|O1|Outcome|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
1158174|NCT00416494|O2|Outcome|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
1158175|NCT00416494|O1|Outcome|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
1158176|NCT00416494|O2|Outcome|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
1158177|NCT00416494|O1|Outcome|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
1158282|NCT00415623|O1|Outcome|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
1158178|NCT00416494|E2|Reported Event|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
1158179|NCT00416494|E1|Reported Event|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
1158180|NCT00416455|B3|Baseline|Total|Total of all reporting groups
1158181|NCT00416455|B2|Baseline|Endometrial Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
1158182|NCT00416455|B1|Baseline|Cervical Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
1158183|NCT00416455|P2|Participant Flow|Endometrial Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
1158184|NCT00416455|P1|Participant Flow|Cervical Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
1158185|NCT00416455|O2|Outcome|Endometrial Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
1158186|NCT00416455|O1|Outcome|Cervical Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
1158187|NCT00416455|O2|Outcome|Endometrial Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
1158188|NCT00416455|O1|Outcome|Cervical Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
1158189|NCT00416455|O2|Outcome|Endometrial Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
1158190|NCT00416455|O1|Outcome|Cervical Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
1158191|NCT00416455|O2|Outcome|Endometrial Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
1158192|NCT00416455|O1|Outcome|Cervical Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
1158193|NCT00416455|E2|Reported Event|Endometrial Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
1158194|NCT00416455|E1|Reported Event|Cervical Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
1158195|NCT00416195|B3|Baseline|Total|Total of all reporting groups
1158196|NCT00416195|B2|Baseline|Perampanel|2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase [Days 71 to 84] and a 4-week Maintenance Phase [Days 85 to 112])
1158197|NCT00416195|B1|Baseline|Placebo|Matching placebo once daily for 16 weeks (Days 1 to 112)
1158268|NCT00415623|P1|Participant Flow|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
1158269|NCT00415623|O3|Outcome|Week 8|
1158270|NCT00415623|O2|Outcome|Week 4|
1158271|NCT00415623|O1|Outcome|Baseline|After once daily administration of amlodipine 5 mg for 8 weeks in the screening period
1158198|NCT00416195|P2|Participant Flow|Perampanel|2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase [Days 71 to 84] and a 4-week Maintenance Phase [Days 85 to 112])
1158199|NCT00416195|P1|Participant Flow|Placebo|Matching placebo once daily for 16 weeks (Days 1 to 112)
1158200|NCT00416195|O2|Outcome|Perampanel|2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase [Days 71 to 84] and a 4-week Maintenance Phase [Days 85 to 112])
1158201|NCT00416195|O1|Outcome|Placebo|Matching placebo once daily for 16 weeks (Days 1 to 112)
1158202|NCT00416195|O2|Outcome|Perampanel|2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase [Days 71 to 84] and a 4-week Maintenance Phase [Days 85 to 112])
1158203|NCT00416195|O1|Outcome|Placebo|Matching placebo once daily for 16 weeks (Days 1 to 112)
1158283|NCT00415623|O2|Outcome|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
1163377|NCT00402987|O2|Outcome|Celecoxib 100 mg / Placebo|
1158204|NCT00416195|E2|Reported Event|Perampanel|2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase [Days 71 to 84] and a 4-week Maintenance Phase [Days 85 to 112])
1158205|NCT00416195|E1|Reported Event|Placebo|Matching placebo once daily for 16 weeks (Days 1 to 112)
1158206|NCT00416182|B3|Baseline|Total|Total of all reporting groups
1158207|NCT00416182|B2|Baseline|Placebo|2.5 mL of placebo comparator
1158208|NCT00416182|B1|Baseline|Pulmozyme (Dornase Alfa)|2.5 mg/2.5 mL of intranasal Pulmozyme
1158209|NCT00416182|P2|Participant Flow|Placebo|2.5mg/2.5mL placebo administered intranasally once daily
1158210|NCT00416182|P1|Participant Flow|Pulmozyme (Dornase Alfa)|2.5 mg/2.5mL of Pulmozyme administered intranasally once daily
1158211|NCT00416182|O2|Outcome|Placebo|Percent predicted forced expiratory volume in 1 second recorded
1158212|NCT00416182|O1|Outcome|Pulmozyme|Percent predicted for forced expiratory volume in 1 second recorded
1158213|NCT00416182|O2|Outcome|Placebo|Scores from the Chronic Sinusitis Survey recorded
1158214|NCT00416182|O1|Outcome|Pulmozyme|Scores from the Chronic Sinusitis Survey
1158215|NCT00416182|O2|Outcome|Placebo|endoscopic photos of sinuses by ENT surgeon, independently and blindly scored by two surgeons. Scores of 0,1,2 based on disease severity.
1158216|NCT00416182|O1|Outcome|Pulmozyme|endoscopic photos of sinuses by ENT surgeon independently and blindly scored by two surgeons with scale of 0,1,2 to indicate severity of disease
1158217|NCT00416182|O2|Outcome|Placebo|Patients receiving intranasal placebo once daily
1158218|NCT00416182|O1|Outcome|Pulmozyme|Patients receiving 2.5 mg intranasal Pulmozyme once daily
1158219|NCT00416182|E2|Reported Event|Placebo|patients receiving once daily intranasal placebo
1158220|NCT00416182|E1|Reported Event|Pulmozyme|patients receiving once daily intranasal Pulmozyme
1158221|NCT00416078|B3|Baseline|Total|Total of all reporting groups
1158222|NCT00416078|B2|Baseline|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year customary care
1158223|NCT00416078|B1|Baseline|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
1158224|NCT00416078|P2|Participant Flow|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year of customary care
1158225|NCT00416078|P1|Participant Flow|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
1158226|NCT00416078|O2|Outcome|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year of customary care
1158227|NCT00416078|O1|Outcome|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
1158228|NCT00416078|O2|Outcome|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year of customary care
1158229|NCT00416078|O1|Outcome|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
1158230|NCT00416078|O2|Outcome|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year of customary care
1158231|NCT00416078|O1|Outcome|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
1158232|NCT00416078|O2|Outcome|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year of customary care
1158233|NCT00416078|O1|Outcome|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
1158234|NCT00416078|O2|Outcome|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year of customary care
1158235|NCT00416078|O1|Outcome|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
1158236|NCT00416078|O2|Outcome|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year of customary care
1158237|NCT00416078|O1|Outcome|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
1158238|NCT00416078|E2|Reported Event|Caregiver Brief Supportive Phone Calls|caregiver brief supportive telephone calls for 6 months embedded in one year of customary care
1158239|NCT00416078|E1|Reported Event|Caregiver Website Support|caregiver access to website support for 6 months embedded in one year of customary care
1158272|NCT00415623|O3|Outcome|Week 8|
1158240|NCT00415909|B1|Baseline|TALL-104 + IM|"TALL-104 cells and imatinib mesylate (IM) therapy~Imatinib Mesylate (IM): IM Therapy of (100 mg or 400 mg) tablets by mouth, same dose each day.~TALL-104 cells: TALL-104 cells will be given intravenously over 1 hour at the dose of 109 cells daily for 4 days, on days 1 to 4 of the cycle, and then again on days 7, 10, 14, 17 and 21 of the cycle. One cycle is equal to 28 days. Patients will receive only one cycle of therapy with TALL-104 cells"
1158241|NCT00415909|P1|Participant Flow|TALL-104 + IM|"TALL-104 cells and imatinib mesylate (IM) therapy. Imatinib Mesylate (IM): IM Therapy of (100 mg or 400 mg) tablets by mouth, same dose each day.~T Acute Lymphoblastic Leukemia/Lymphoma (TALL)-104 cells: TALL-104 cells will be given intravenously over 1 hour at the dose of 109 cells daily for 4 days, on days 1 to 4 of the cycle, and then again on days 7, 10, 14, 17 and 21 of the cycle. One cycle is equal to 28 days. Patients will receive only one cycle of therapy with TALL-104 cells"
1158242|NCT00415909|O1|Outcome|TALL-104 + IM|"TALL-104 cells and imatinib mesylate (IM) therapy~Imatinib Mesylate (IM): IM Therapy of (100 mg or 400 mg) tablets by mouth, same dose each day.~TALL-104 cells: TALL-104 cells will be given intravenously over 1 hour at the dose of 109 cells daily for 4 days, on days 1 to 4 of the cycle, and then again on days 7, 10, 14, 17 and 21 of the cycle. One cycle is equal to 28 days. Patients will receive only one cycle of therapy with TALL-104 cells"
1158243|NCT00415909|E1|Reported Event|TALL-104 + IM|"TALL-104 cells and imatinib mesylate (IM) therapy~Imatinib Mesylate (IM): IM Therapy of (100 mg or 400 mg) tablets by mouth, same dose each day.~TALL-104 cells: TALL-104 cells will be given intravenously over 1 hour at the dose of 109 cells daily for 4 days, on days 1 to 4 of the cycle, and then again on days 7, 10, 14, 17 and 21 of the cycle. One cycle is equal to 28 days. Patients will receive only one cycle of therapy with TALL-104 cells"
1158244|NCT00415870|B3|Baseline|Total|Total of all reporting groups
1158247|NCT00415870|P2|Participant Flow|PACE|"Received text messages and counseling calls~Food Monitoring : Food Monitoring~Text Message : Text Message~Cell phone will serve as a self monitoring device : Cell phone will serve as a self monitoring device~Diet Goals via Cell Phone : Diet Goals via Cell Phone~Weekly Weighing : Weekly Weighing~Printed Material : Printed Material"
1158248|NCT00415870|P1|Participant Flow|Control|
1158249|NCT00415870|O2|Outcome|PACE: Intervention - SMS Messages|
1158250|NCT00415870|O1|Outcome|Control:Enhanced Usual Care|
1158251|NCT00415870|E2|Reported Event|PACE|"Received text messages and counseling calls~Food Monitoring : Food Monitoring~Text Message : Text Message~Cell phone will serve as a self monitoring device : Cell phone will serve as a self monitoring device~Diet Goals via Cell Phone : Diet Goals via Cell Phone~Weekly Weighing : Weekly Weighing~Printed Material : Printed Material"
1158252|NCT00415870|E1|Reported Event|Control|
1158253|NCT00415857|B3|Baseline|Total|Total of all reporting groups
1158254|NCT00415857|B2|Baseline|PR1 + Imatinib + Interferon|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination, and Peginterferon alfa-2b 0.5 microg/kg subcutaneous injection with each PR1 vaccination.
1158255|NCT00415857|B1|Baseline|PR1 + Imatinib|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination.
1158256|NCT00415857|P2|Participant Flow|PR1 + Imatinib + Interferon|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination, and Peginterferon alfa-2b 0.5 microg/kg subcutaneous injection with each PR1 vaccination.
1158257|NCT00415857|P1|Participant Flow|PR1 + Imatinib|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination.
1158258|NCT00415857|O2|Outcome|PR1 + Imatinib + Interferon|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination, and Peginterferon alfa-2b 0.5 microg/kg subcutaneous injection with each PR1 vaccination.
1158259|NCT00415857|O1|Outcome|PR1 + Imatinib|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination.
1158260|NCT00415857|O2|Outcome|PR1 + Imatinib + Interferon|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination, and Peginterferon alfa-2b 0.5 microg/kg subcutaneous injection with each PR1 vaccination.
1158261|NCT00415857|O1|Outcome|PR1 + Imatinib|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination.
1158262|NCT00415857|E2|Reported Event|PR1 + Imatinib + Interferon|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination, and Peginterferon alfa-2b 0.5 microg/kg subcutaneous injection with each PR1 vaccination.
1158263|NCT00415857|E1|Reported Event|PR1 + Imatinib|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination.
1158264|NCT00415623|B3|Baseline|Total|Total of all reporting groups
1158265|NCT00415623|B2|Baseline|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
1158266|NCT00415623|B1|Baseline|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
1158273|NCT00415623|O2|Outcome|Week 4|
1158276|NCT00415623|O1|Outcome|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
1158277|NCT00415623|O2|Outcome|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
1158278|NCT00415623|O1|Outcome|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
1158279|NCT00415623|O2|Outcome|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
1158280|NCT00415623|O1|Outcome|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
1158399|NCT00414973|B1|Baseline|Teriparatide - Females|Subcutaneous, 20 micrograms/day, 24 weeks
1158284|NCT00415623|O1|Outcome|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
1158285|NCT00415623|O2|Outcome|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
1158286|NCT00415623|O1|Outcome|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
1158287|NCT00415623|O2|Outcome|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
1158288|NCT00415623|O1|Outcome|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
1158289|NCT00415623|O2|Outcome|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
1158290|NCT00415623|O1|Outcome|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
1158291|NCT00415610|B4|Baseline|Total|Total of all reporting groups
1158292|NCT00415610|B3|Baseline|Tier 3|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine to a range between 110 to 140 mmHg. Treatment with nicardipine must begin within 6 hours of symptom onset and will continue for an estimated 18 - 24 hours, until SBP is stabilized. The assigned SBP range will be maintained for 24 hours. After 24 hours, management of blood pressure is at the discretion of the primary physician.~nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
1158293|NCT00415610|B2|Baseline|Tier 2|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine to a range between 140 to 170 mmHg. Treatment with nicardipine must begin within 6 hours of symptom onset and will continue for an estimated 18 - 24 hours, until SBP is stabilized. The assigned SBP range will be maintained for 24 hours. After 24 hours, management of blood pressure is at the discretion of the primary physician.~nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
1158294|NCT00415610|B1|Baseline|Tier 1|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine to a range between 170 to 200 mmHg. Treatment with nicardipine must begin within 6 hours of symptom onset and will continue for an estimated 18 - 24 hours, until SBP is stabilized. The assigned SBP range will be maintained for 24 hours. After 24 hours, management of blood pressure is at the discretion of the primary physician.~nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
1158295|NCT00415610|P3|Participant Flow|Tier 3|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 110 to 140 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
1158296|NCT00415610|P2|Participant Flow|Tier 2|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 140 to 170 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
1158297|NCT00415610|P1|Participant Flow|Tier 1|"Dose escalation: Initial range~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 170 to 200 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
1158443|NCT00414908|E2|Reported Event|Placebo (DB)|Placebo group meaning the treatment received during the 7-days double-blind period
1158298|NCT00415610|O3|Outcome|Tier 3|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 110 to 140 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
1158343|NCT00415506|P1|Participant Flow|Scleritis|Patients with non-infectious scleritis and is a phase II, randomized, double-blinded, prospective clinical trial of two different doses of rituximab to compare the safety and efficacy of these 2 doses. Patients will be randomized to either 500 mg or 1000 mg of rituximab administered intravenously two weeks apart.
1158344|NCT00415506|O2|Outcome|Orbital Inflammation|Subjects with Orbital Inflammation
1158345|NCT00415506|O1|Outcome|Scleritis|Subjects with Scleritis
1158299|NCT00415610|O2|Outcome|Tier 2|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 140 to 170 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
1158300|NCT00415610|O1|Outcome|Tier 1|"Dose escalation: Initial range~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 170 to 200 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
1158301|NCT00415610|O3|Outcome|Tier 3|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 110 to 140 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
1158302|NCT00415610|O2|Outcome|Tier 2|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 140 to 170 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
1158303|NCT00415610|O1|Outcome|Tier 1|"Dose escalation: Initial range~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 170 to 200 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
1158304|NCT00415610|O3|Outcome|Tier 3|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 110 to 140 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
1158305|NCT00415610|O2|Outcome|Tier 2|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 140 to 170 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
1158306|NCT00415610|O1|Outcome|Tier 1|"Dose escalation: Initial range~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 170 to 200 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
1158307|NCT00415610|E3|Reported Event|Tier 3|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 110 to 140 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
1158308|NCT00415610|E2|Reported Event|Tier 2|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 140 to 170 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
1158346|NCT00415506|O2|Outcome|Orbital Inflammation|Subjects with Orbital Inflammation
1158347|NCT00415506|O1|Outcome|Scleritis|Subjects with Scleritis
1158348|NCT00415506|E2|Reported Event|Scleritis|Subjects with Scleritis
1158349|NCT00415506|E1|Reported Event|Orbital Inflammation|Subjects with Orbital Inflammation
1158309|NCT00415610|E1|Reported Event|Tier 1|"Dose escalation: Initial range~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 170 to 200 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
1158310|NCT00415597|B1|Baseline|ALO-01|
1158311|NCT00415597|P1|Participant Flow|ALO-01|
1158312|NCT00415597|O1|Outcome|ALO-01|
1158313|NCT00415597|O1|Outcome|ALO-01|
1158314|NCT00415597|O1|Outcome|ALO-01|
1158315|NCT00415597|E1|Reported Event|ALO-01|
1158316|NCT00415532|B3|Baseline|Total|Total of all reporting groups
1158317|NCT00415532|B2|Baseline|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
1158318|NCT00415532|B1|Baseline|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
1158319|NCT00415532|P2|Participant Flow|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
1158320|NCT00415532|P1|Participant Flow|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
1158321|NCT00415532|O2|Outcome|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
1158322|NCT00415532|O1|Outcome|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
1158323|NCT00415532|O2|Outcome|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
1158324|NCT00415532|O1|Outcome|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
1158325|NCT00415532|O2|Outcome|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
1158326|NCT00415532|O1|Outcome|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
1158327|NCT00415532|O2|Outcome|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
1158328|NCT00415532|O1|Outcome|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
1158329|NCT00415532|O2|Outcome|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
1158330|NCT00415532|O1|Outcome|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
1158331|NCT00415532|O2|Outcome|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
1158332|NCT00415532|O1|Outcome|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
1158333|NCT00415532|O2|Outcome|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
1158334|NCT00415532|O1|Outcome|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
1158335|NCT00415532|O2|Outcome|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
1158444|NCT00414908|E1|Reported Event|Pancrelipase (DB)|Pancrelipase delayed release capsules meaning the treatment received during the 7-days double-blind period
1158336|NCT00415532|O1|Outcome|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
1158337|NCT00415532|E2|Reported Event|AMG 531|
1158338|NCT00415532|E1|Reported Event|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
1158339|NCT00415506|B3|Baseline|Total|Total of all reporting groups
1158340|NCT00415506|B2|Baseline|Orbital Inflammation|Subjects with Orbital Inflammation
1158341|NCT00415506|B1|Baseline|Scleritis|Subjects with Scleritis
1158342|NCT00415506|P2|Participant Flow|Orbital Inflammation|Patients with non-infectious orbital inflammatory disease, and is a phase I, prospective clinical trial to examine the safety of the 2 infusions of rituximab intravenously, 2 weeks apart, in the treatment of non-infectious orbital inflammation. The first 5 patients will receive 1000 mg of rituximab at each infusion, any additional patients will be randomized to receive either 500 mg or 1000 mg of rituximab.
1158353|NCT00415493|P2|Participant Flow|Warm-moist Air Followed by Cold-dry Air|To control for possible stimulus-order effects, half of the subjects were evaluated pre- and post-exposure to Warm-moist air followed (on a separate day) by Cold-dry air. Exposures lasted 15 minutes, with a one-hour follow-up period.
1158354|NCT00415493|P1|Participant Flow|Cold-dry Air Followed by Warm-moist Air|To control for possible stimulus-order effects, half of the subjects were evaluated pre- and post-exposure to Cold-dry air followed (on a separate day) by Warm-moist air. Exposures lasted 15 minutes, with a one-hour follow-up period.
1158355|NCT00415493|O2|Outcome|Controls|normal subjects
1158356|NCT00415493|O1|Outcome|Cases|non-allergic rhinitis subjects
1158357|NCT00415493|E2|Reported Event|Controls|normal subjects
1158358|NCT00415493|E1|Reported Event|Cases|non-allergic rhinitis subjects
1158359|NCT00415194|B3|Baseline|Total|Total of all reporting groups
1158360|NCT00415194|B2|Baseline|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
1158361|NCT00415194|B1|Baseline|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
1158362|NCT00415194|P2|Participant Flow|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
1158363|NCT00415194|P1|Participant Flow|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
1158364|NCT00415194|O2|Outcome|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
1158365|NCT00415194|O1|Outcome|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
1158366|NCT00415194|O2|Outcome|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
1158445|NCT00414817|B3|Baseline|Total|Total of all reporting groups
1158446|NCT00414817|B2|Baseline|Usual Care|usual care participants who were included in the primary outcome analysis. This consists of existing users of inhaled corticosteroids at the outset of the study, qualified (or for UC would have qualified) for an intervention call at some point during the study, had at least 3 months of follow-up, and were not subsequently determined to be daily oral steroid users.
1163302|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1158367|NCT00415194|O1|Outcome|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
1158368|NCT00415194|O2|Outcome|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
1158386|NCT00415168|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
1158387|NCT00415168|E1|Reported Event|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
1158388|NCT00415051|B1|Baseline|Single Group Assignment|"RVF MP-12~RVF MP-12: Administer 1 ml SQ"
1158389|NCT00415051|P1|Participant Flow|Single Group Assignment|"RVF MP-12~RVF MP-12: Administer 1 ml SQ"
1158369|NCT00415194|O1|Outcome|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
1158370|NCT00415194|O2|Outcome|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
1158371|NCT00415194|O1|Outcome|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
1158372|NCT00415194|O2|Outcome|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
1158373|NCT00415194|O1|Outcome|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
1158374|NCT00415194|O2|Outcome|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
1158375|NCT00415194|O1|Outcome|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
1158376|NCT00415194|E2|Reported Event|Placebo/Cisplatin|Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m2 on Day 1 every 21 days. Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.
1158473|NCT00414700|P1|Participant Flow|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
1158505|NCT00414661|O4|Outcome|Adalimumab|Participants who had received 1 dose of adalimumab in any of the previous studies.
1158377|NCT00415194|E1|Reported Event|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meter square (mg/m2) administered intravenously (IV) plus cisplatin 75 mg/m2 IV on Day 1 every 21 days. Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.
1158378|NCT00415168|B1|Baseline|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
1158379|NCT00415168|P1|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
1158380|NCT00415168|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
1158381|NCT00415168|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
1158382|NCT00415168|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
1158383|NCT00415168|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
1158384|NCT00415168|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
1158385|NCT00415168|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
1158390|NCT00415051|O1|Outcome|Single Group Assignment|"RVF MP-12~RVF MP-12: Administer 1 ml SQ"
1158400|NCT00414973|P4|Participant Flow|Calcitonin - Males|Intranasal, 200 IU/day, 24 weeks
1158401|NCT00414973|P3|Participant Flow|Teriparatide - Males|Subcutaneous, 20 micrograms/day, 24 weeks
1158402|NCT00414973|P2|Participant Flow|Calcitonin - Females|Intranasal, 200 International Units (IU)/day, 24 weeks
1158403|NCT00414973|P1|Participant Flow|Teriparatide - Females|Subcutaneous, 20 micrograms/day, 24 weeks
1158404|NCT00414973|O2|Outcome|Calcitonin - Males|Intranasal, 200 IU/day, 24 weeks
1158405|NCT00414973|O1|Outcome|Teriparatide - Males|Subcutaneous, 20 micrograms/day, 24 weeks
1158406|NCT00414973|O2|Outcome|Calcitonin - Males|Intranasal, 200 IU/day, 24 weeks
1158407|NCT00414973|O1|Outcome|Teriparatide - Males|Subcutaneous, 20 micrograms/day, 24 weeks
1158408|NCT00414973|O2|Outcome|Calcitonin - Males|Intranasal, 200 IU/day, 24 weeks
1158409|NCT00414973|O1|Outcome|Teriparatide - Males|Subcutaneous, 20 micrograms/day, 24 weeks
1158410|NCT00414973|O2|Outcome|Calcitonin - Females|Intranasal, 200 IU/day, 24 weeks
1158411|NCT00414973|O1|Outcome|Teriparatide - Females|Subcutaneous, 20 micrograms/day, 24 weeks
1158412|NCT00414973|O2|Outcome|Calcitonin - Females|Intranasal, 200 IU/day, 24 weeks
1158413|NCT00414973|O1|Outcome|Teriparatide - Females|Subcutaneous, 20 micrograms/day, 24 weeks
1158414|NCT00414973|O2|Outcome|Calcitonin - Females|Intranasal, 200 IU/day, 24 weeks
1158415|NCT00414973|O1|Outcome|Teriparatide - Females|Subcutaneous, 20 micrograms/day, 24 weeks
1158416|NCT00414973|E4|Reported Event|Calcitonin - Males|Intranasal, 200 IU/day, 24 weeks
1158417|NCT00414973|E3|Reported Event|Teriparatide - Males|Subcutaneous, 20 micrograms/day, 24 weeks
1158418|NCT00414973|E2|Reported Event|Calcitonin - Females|Intranasal, 200 International Units (IU)/day, 24 weeks
1158419|NCT00414973|E1|Reported Event|Teriparatide - Females|Subcutaneous, 20 micrograms/day, 24 weeks
1158420|NCT00414908|B3|Baseline|Total|Total of all reporting groups
1158421|NCT00414908|B2|Baseline|Placebo (DB)|Placebo group given during the Double-Blind period
1158422|NCT00414908|B1|Baseline|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
1158423|NCT00414908|P2|Participant Flow|Placebo (DB)|Placebo group given during the Double-Blind period
1158424|NCT00414908|P1|Participant Flow|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
1158425|NCT00414908|O1|Outcome|Pancrelipase (OL)|Pancrelipase delayed during Open-label. Dosing is directed by the investigator.
1158426|NCT00414908|O2|Outcome|Placebo (DB)|Placebo group given during the Double-Blind period
1158427|NCT00414908|O1|Outcome|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
1158428|NCT00414908|O2|Outcome|Placebo (DB)|Placebo group given during the Double-Blind period
1158429|NCT00414908|O1|Outcome|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
1158430|NCT00414908|O2|Outcome|Placebo (DB)|Placebo group given during the Double-Blind period
1158431|NCT00414908|O1|Outcome|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
1158432|NCT00414908|O2|Outcome|Placebo (DB)|Placebo group given during the Double-Blind period
1158433|NCT00414908|O1|Outcome|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
1158434|NCT00414908|O2|Outcome|Placebo (DB)|Placebo group given during the Double-Blind period
1158435|NCT00414908|O1|Outcome|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
1158436|NCT00414908|O2|Outcome|Placebo (DB)|Placebo group given during the Double-Blind period
1158437|NCT00414908|O1|Outcome|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
1158438|NCT00414908|O2|Outcome|Placebo (DB)|Placebo group given during the Double-Blind period
1158439|NCT00414908|O1|Outcome|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
1158440|NCT00414908|O2|Outcome|Placebo (DB)|Placebo group given during the Double-Blind period
1158441|NCT00414908|O1|Outcome|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
1158442|NCT00414908|E3|Reported Event|Pancrelipase (OL)|Pancrelipase delayed capsules received by the patients during the 6-month Open Label. The dosing was directed by the investigator.
1158447|NCT00414817|B1|Baseline|Automated Phone-Based Refill Reminders|Intervention arm participants who were included in the primary outcome analysis. This consists of existing users of inhaled corticosteroids at the outset of the study, qualified (or for UC would have qualified) for an intervention call at some point during the study, had at least 3 months of follow-up, and were not subsequently determined to be daily oral steroid users.
1158448|NCT00414817|P2|Participant Flow|Usual Care|"Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the usual care study arm, and therefore, receive no intervention."
1158449|NCT00414817|P1|Participant Flow|Automated Phone-Based Refill Reminders|"Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period.~Automated Phone-Based Refill Reminders : The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions."
1163378|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1158450|NCT00414817|O2|Outcome|Usual Care|"Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the usual care study arm, and therefore, receive no intervention."
1158451|NCT00414817|O1|Outcome|Automated Phone-Based Refill Reminders|"Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period.~Automated Phone-Based Refill Reminders : The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions."
1158452|NCT00414817|O2|Outcome|Usual Care|"Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the usual care study arm, and therefore, receive no intervention."
1158453|NCT00414817|O1|Outcome|Automated Phone-Based Refill Reminders|"Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period.~Automated Phone-Based Refill Reminders : The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions."
1158454|NCT00414817|O2|Outcome|Usual Care|"Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the usual care study arm, and therefore, receive no intervention."
1158455|NCT00414817|O1|Outcome|Automated Phone-Based Refill Reminders|"Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period.~Automated Phone-Based Refill Reminders : The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions."
1158456|NCT00414817|E2|Reported Event|Usual Care|"Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the usual care study arm, and therefore, receive no intervention."
1158457|NCT00414817|E1|Reported Event|Automated Phone-Based Refill Reminders|"Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period.~Automated Phone-Based Refill Reminders : The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions."
1158458|NCT00414726|B3|Baseline|Total|Total of all reporting groups
1158459|NCT00414726|B2|Baseline|Room Air|Room Air, inhaled at 30-45L/min via a facemask for 8 hours
1158460|NCT00414726|B1|Baseline|Normobaric Oxygen|Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
1158461|NCT00414726|P2|Participant Flow|Room Air|Room Air, inhaled at 30-45L/min via a facemask for 8 hours
1158462|NCT00414726|P1|Participant Flow|Normobaric Oxygen|Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
1158463|NCT00414726|O2|Outcome|Room Air|Room Air, inhaled at 30-45L/min via a facemask for 8 hours
1158464|NCT00414726|O1|Outcome|Normobaric Oxygen|Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
1158465|NCT00414726|O2|Outcome|Room Air|Room Air, inhaled at 30-45L/min via a facemask for 8 hours
1158466|NCT00414726|O1|Outcome|Normobaric Oxygen|Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
1158467|NCT00414726|E2|Reported Event|Room Air|Room Air, inhaled at 30-45L/min via a facemask for 8 hours
1158468|NCT00414726|E1|Reported Event|Normobaric Oxygen|Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
1158469|NCT00414700|B3|Baseline|Total|Total of all reporting groups
1158470|NCT00414700|B2|Baseline|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
1158471|NCT00414700|B1|Baseline|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
1158472|NCT00414700|P2|Participant Flow|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
1158474|NCT00414700|O2|Outcome|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
1158475|NCT00414700|O1|Outcome|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
1158476|NCT00414700|O2|Outcome|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
1158477|NCT00414700|O1|Outcome|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
1158478|NCT00414700|O2|Outcome|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
1158479|NCT00414700|O1|Outcome|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
1158480|NCT00414700|O2|Outcome|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
1158481|NCT00414700|O1|Outcome|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
1158482|NCT00414700|O2|Outcome|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
1158483|NCT00414700|O1|Outcome|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
1158484|NCT00414700|O2|Outcome|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
1158485|NCT00414700|O1|Outcome|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
1158486|NCT00414700|O2|Outcome|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
1158487|NCT00414700|O1|Outcome|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
1158488|NCT00414700|O2|Outcome|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
1158489|NCT00414700|O1|Outcome|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
1158490|NCT00414700|E2|Reported Event|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
1158491|NCT00414700|E1|Reported Event|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
1158492|NCT00414661|B5|Baseline|Total|Total of all reporting groups
1158493|NCT00414661|B4|Baseline|Adalimumab|Participants who had received 1 dose of adalimumab in any of the previous studies.
1158494|NCT00414661|B3|Baseline|Placebo|Participants who had received 1 dose of matching-placebo in any of the previous studies.
1158495|NCT00414661|B2|Baseline|CP-690,550 <10 mg|Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.
1158496|NCT00414661|B1|Baseline|CP-690,550 >=10 mg|Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.
1158497|NCT00414661|P4|Participant Flow|Adalimumab|Participants who had received 1 dose of adalimumab in any of the previous studies.
1158498|NCT00414661|P3|Participant Flow|Placebo|Participants who had received 1 dose of matching-placebo in any of the previous studies.
1158499|NCT00414661|P2|Participant Flow|CP-690,550 <10 mg|Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.
1158500|NCT00414661|P1|Participant Flow|CP-690,550 >=10 mg|Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.
1158501|NCT00414661|O4|Outcome|Adalimumab|Participants who had received 1 dose of adalimumab in any of the previous studies.
1158502|NCT00414661|O3|Outcome|Placebo|Participants who had received 1 dose of matching-placebo in any of the previous studies.
1158503|NCT00414661|O2|Outcome|CP-690,550 <10 mg|Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.
1158504|NCT00414661|O1|Outcome|CP-690,550 >=10 mg|Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.
1158506|NCT00414661|O3|Outcome|Placebo|Participants who had received 1 dose of matching-placebo in any of the previous studies.
1158507|NCT00414661|O2|Outcome|CP-690,550 <10 mg|Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.
1158508|NCT00414661|O1|Outcome|CP-690,550 >=10 mg|Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.
1158509|NCT00414661|O4|Outcome|Adalimumab|Participants who had received 1 dose of adalimumab in any of the previous studies.
1158510|NCT00414661|O3|Outcome|Placebo|Participants who had received 1 dose of matching-placebo in any of the previous studies.
1158511|NCT00414661|O2|Outcome|CP-690,550 <10 mg|Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.
1158512|NCT00414661|O1|Outcome|CP-690,550 >=10 mg|Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.
1158513|NCT00414661|O4|Outcome|Adalimumab|Participants who had received 1 dose of adalimumab in any of the previous studies.
1158514|NCT00414661|O3|Outcome|Placebo|Participants who had received 1 dose of matching-placebo in any of the previous studies.
1158515|NCT00414661|O2|Outcome|CP-690,550 <10 mg|Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.
1158516|NCT00414661|O1|Outcome|CP-690,550 >=10 mg|Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.
1158517|NCT00414661|E4|Reported Event|Adalimumab|Participants who had received 1 dose of adalimumab in any of the previous studies.
1158518|NCT00414661|E3|Reported Event|Placebo|Participants who had received 1 dose of matching-placebo in any of the previous studies.
1158519|NCT00414661|E2|Reported Event|CP-690,550 <10 mg|Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.
1158520|NCT00414661|E1|Reported Event|CP-690,550 >=10 mg|Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.
1158521|NCT00414635|B3|Baseline|Total|Total of all reporting groups
1158522|NCT00414635|B2|Baseline|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
1158523|NCT00414635|B1|Baseline|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
1158524|NCT00414635|P2|Participant Flow|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
1158525|NCT00414635|P1|Participant Flow|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
1158526|NCT00414635|O2|Outcome|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
1158527|NCT00414635|O1|Outcome|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
1158528|NCT00414635|O2|Outcome|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
1158529|NCT00414635|O1|Outcome|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
1158530|NCT00414635|O2|Outcome|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
1158531|NCT00414635|O1|Outcome|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
1158532|NCT00414635|O2|Outcome|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
1158533|NCT00414635|O1|Outcome|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
1158534|NCT00414635|O2|Outcome|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
1158535|NCT00414635|O1|Outcome|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
1158536|NCT00414635|O2|Outcome|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
1158703|NCT00414206|B1|Baseline|1% Mecamylamine|
1158704|NCT00414206|P3|Participant Flow|Placebo|
1158537|NCT00414635|O1|Outcome|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
1158538|NCT00414635|O2|Outcome|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
1158539|NCT00414635|O1|Outcome|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
1158574|NCT00414596|O1|Outcome|DRX Group|Patients using the device DRX9000™.
1158575|NCT00414596|O1|Outcome|DRX Group|Patients using the device DRX9000™.
1163379|NCT00402987|O3|Outcome|Placebo|
1158540|NCT00414635|E2|Reported Event|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
1158541|NCT00414635|E1|Reported Event|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
1158542|NCT00414609|B3|Baseline|Total|Total of all reporting groups
1158543|NCT00414609|B2|Baseline|Aliskiren|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
1158544|NCT00414609|B1|Baseline|Placebo|Placebo for 36 weeks once daily in the morning
1158545|NCT00414609|P3|Participant Flow|Aliskiren_Extension|"Patients from both the arms of the core study who completed core study and signed informed consent form were included in this arm of extension study.~Patients received 150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study."
1158546|NCT00414609|P2|Participant Flow|Aliskiren_Core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
1158547|NCT00414609|P1|Participant Flow|Placebo_Core|Placebo for 36 weeks once daily in the morning
1158548|NCT00414609|O1|Outcome|Aliskiren_Extension|"Patients from both the arms of the core study who completed core study and signed informed consent form were included in this arm of extension study.~Patients received 150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study."
1158549|NCT00414609|O1|Outcome|Aliskiren_Extension|"Patients from both the arms of the core study who completed core study and signed informed consent form were included in this arm of extension study.~Patients received 150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study."
1158550|NCT00414609|O1|Outcome|Aliskiren_Extension|"Patients from both the arms of the core study who completed core study and signed informed consent form were included in this arm of extension study.~Patients received 150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study."
1158551|NCT00414609|O1|Outcome|Aliskiren_Extension|150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study.
1158552|NCT00414609|O1|Outcome|Aliskiren_Extension|"Patients from both the arms of the core study who completed core study and signed informed consent form were included in this arm of extension study.~Patients received 150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study."
1158553|NCT00414609|O1|Outcome|Aliskiren_Extension|"Patients from both the arms of the core study who completed core study and signed informed consent form were included in this arm of extension study.~Patients received 150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study."
1158554|NCT00414609|O2|Outcome|Aliskiren_Core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
1158555|NCT00414609|O1|Outcome|Placebo_Core|Placebo for 36 weeks once daily in the morning
1158556|NCT00414609|O2|Outcome|Aliskiren_Core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
1158557|NCT00414609|O1|Outcome|Placebo_Core|Placebo for 36 weeks once daily in the morning
1158558|NCT00414609|O2|Outcome|Aliskiren_Core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
1158559|NCT00414609|O1|Outcome|Placebo_Core|Placebo for 36 weeks once daily in the morning
1158560|NCT00414609|O2|Outcome|Aliskiren_Core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
1158561|NCT00414609|O1|Outcome|Placebo_Core|Placebo for 36 weeks once daily in the morning
1158562|NCT00414609|O2|Outcome|Aliskiren_Core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
1158563|NCT00414609|O1|Outcome|Placebo_Core|Placebo for 36 weeks once daily in the morning
1158564|NCT00414609|O2|Outcome|Aliskiren_Core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
1158565|NCT00414609|O1|Outcome|Placebo_Core|Placebo for 36 weeks once daily in the morning
1158705|NCT00414206|P2|Participant Flow|0.3% Mecamylamine|
1158566|NCT00414609|E3|Reported Event|Aliskiren_extension|"Patients from both the arms of the core study who completed core study and signed informed consent form were included in this arm of extension study.~Patients received 150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study."
1158567|NCT00414609|E2|Reported Event|Aliskiren_core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
1158568|NCT00414609|E1|Reported Event|Placebo_core|Placebo for 36 weeks once daily in the morning
1158569|NCT00414596|B1|Baseline|DRX Group|Patients using the device DRX9000™.
1158570|NCT00414596|P1|Participant Flow|DRX Group|Patients using the device DRX9000™.
1158571|NCT00414596|O1|Outcome|DRX Group|Patients using the device DRX9000™.
1158572|NCT00414596|O1|Outcome|DRX Group|Patients using the device DRX9000™.
1158573|NCT00414596|O1|Outcome|DRX Group|Patients using the device DRX9000™.
1158576|NCT00414596|O1|Outcome|DRX Group|Patients using the device DRX9000™.
1158577|NCT00414596|E1|Reported Event|DRX Group|Patients using the device DRX9000™.
1158578|NCT00414544|B1|Baseline|CosmetaLife vs Restylane|Split-face double blind study design used so each subject received each treatment followed by a two week touch up treatment, where no subject received more than 2cc of either CosmetaLife or Restylane treatment.
1158579|NCT00414544|P1|Participant Flow|CosmetaLife vs Restylane|Split-face double blind study design used so each subject received each treatment followed by a two week touch up treatment, where no subject received more than 2cc of either CosmetaLife or Restylane treatment.
1158580|NCT00414544|O2|Outcome|Restylane (Control)|Restylane (Control) injected nasolabial fold contralateral side
1158581|NCT00414544|O1|Outcome|CosmetaLife|CosmetaLife injected nasolabial fold side
1158582|NCT00414544|E2|Reported Event|Restylane (Control)|
1158583|NCT00414544|E1|Reported Event|CosmetaLife|
1158584|NCT00414518|B3|Baseline|Total|Total of all reporting groups
1158585|NCT00414518|B2|Baseline|Arm B|Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements
1158586|NCT00414518|B1|Baseline|Arm A|Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
1158587|NCT00414518|P2|Participant Flow|CD4 T Cell Guided Therapy|Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements
1158588|NCT00414518|P1|Participant Flow|Treatment Interruption|Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
1158589|NCT00414518|O2|Outcome|CD4 T Cell Guided Therapy|Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements
1158590|NCT00414518|O1|Outcome|12 Week Treatment Folllowed by Treatment Interruption|Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
1158591|NCT00414518|O2|Outcome|Arm B|Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements
1158592|NCT00414518|O1|Outcome|Arm A|Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
1158593|NCT00414518|O2|Outcome|CD4 T Cell Guided Therapyh|Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements
1158594|NCT00414518|O1|Outcome|12 Week Treatment Arm Followed by Treatment Interruption|Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
1158595|NCT00414518|E2|Reported Event|Arm B|Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements
1158596|NCT00414518|E1|Reported Event|Arm A|Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
1158597|NCT00414466|B5|Baseline|Total|Total of all reporting groups
1158598|NCT00414466|B4|Baseline|4 Gabapentin High|Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
1158599|NCT00414466|B3|Baseline|3 Gabapentin Medium|Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
1158600|NCT00414466|B2|Baseline|2 Gabapentin Low|Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
1158601|NCT00414466|B1|Baseline|1 Placebo|Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
1158602|NCT00414466|P4|Participant Flow|4 Gabapentin High (30mg/Day)|Intraspinal Gabapentin High (30mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
1158603|NCT00414466|P3|Participant Flow|3 Gabapentin Medium (6mg/Day)|Intraspinal Gabapentin Medium (6mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
1158706|NCT00414206|P1|Participant Flow|1% Mecamylamine|
1158707|NCT00414206|O3|Outcome|Placebo|
1158604|NCT00414466|P2|Participant Flow|2 Gabapentin Low (1mg/Day)|Intraspinal Gabapentin Low (1mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
1158605|NCT00414466|P1|Participant Flow|1 Placebo (0mg/Day)|Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
1158606|NCT00414466|O4|Outcome|4 Gabapentin High|Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
1158607|NCT00414466|O3|Outcome|3 Gabapentin Medium|Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
1158608|NCT00414466|O2|Outcome|2 Gabapentin Low|Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
1158609|NCT00414466|O1|Outcome|1 Placebo|Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
1158610|NCT00414466|O4|Outcome|4 Gabapentin High|Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
1163380|NCT00402987|O2|Outcome|Celecoxib 100 mg (Pooled)|
1158611|NCT00414466|O3|Outcome|3 Gabapentin Medium|Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
1158612|NCT00414466|O2|Outcome|2 Gabapentin Low|Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
1158613|NCT00414466|O1|Outcome|1 Placebo|Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
1158614|NCT00414466|O4|Outcome|4 Gabapentin High|Intraspinal Gabapentin High (30mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
1158615|NCT00414466|O3|Outcome|3 Gabapentin Medium|Intraspinal Gabapentin Medium (6mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
1158616|NCT00414466|O2|Outcome|2 Gabapentin Low|Intraspinal Gabapentin Low (1mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
1158617|NCT00414466|O1|Outcome|1 Placebo|Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
1158618|NCT00414466|E4|Reported Event|4 Gabapentin High|Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
1158619|NCT00414466|E3|Reported Event|3 Gabapentin Medium|Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
1158620|NCT00414466|E2|Reported Event|2 Gabapentin Low|Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
1158621|NCT00414466|E1|Reported Event|1 Placebo|Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
1158622|NCT00414453|B1|Baseline|Lidocaine 5% + Placebo Patch, ER + Placebo Pills|"5% lidocaine patch used as intervention Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off~placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm Placebo lidocaine patches: used with extended release oxycodone group; used with placebo prandomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating scheduleills/placebo patches~placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
1158623|NCT00414453|P1|Participant Flow|Lidocaine 5% + Placebo Patch, ER + Placebo Pills|"5% lidocaine patch used as intervention Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off~placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm Placebo lidocaine patches: used with extended release oxycodone group; used with placebo prandomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating scheduleills/placebo patches~placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
1158624|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
1158625|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
1158626|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
1158627|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
1158628|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
1158629|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
1158630|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
1158631|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
1158632|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
1158633|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
1158708|NCT00414206|O2|Outcome|0.3% Mecamylamine|
1158709|NCT00414206|O1|Outcome|1% Mecamylamine|
1158710|NCT00414206|E3|Reported Event|Placebo|
1158634|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
1158635|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
1158636|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
1158637|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
1158638|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
1158639|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
1158640|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
1163381|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1158641|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
1158642|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
1158643|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
1158644|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
1158645|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
1158646|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
1158647|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
1158648|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
1158649|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
1158650|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
1158651|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
1158652|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
1158653|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
1158654|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
1158655|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
1158656|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
1158657|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
1158658|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
1158659|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
1158660|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
1158661|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
1158662|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
1158663|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
1158664|NCT00414453|E4|Reported Event|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
1158665|NCT00414453|E3|Reported Event|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
1158711|NCT00414206|E2|Reported Event|0.3% Mecamylamine|
1158712|NCT00414206|E1|Reported Event|1% Mecamylamine|
1158666|NCT00414453|E2|Reported Event|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
1158667|NCT00414453|E1|Reported Event|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
1158668|NCT00414440|B3|Baseline|Total|Total of all reporting groups
1158669|NCT00414440|B2|Baseline|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses.
1158670|NCT00414440|B1|Baseline|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
1158671|NCT00414440|P2|Participant Flow|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses.
1158672|NCT00414440|P1|Participant Flow|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
1158673|NCT00414440|O2|Outcome|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses.
1158725|NCT00414050|B4|Baseline|ENGERIX-B®|Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.
1163382|NCT00402987|O3|Outcome|Placebo|
1158674|NCT00414440|O1|Outcome|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
1158675|NCT00414440|O2|Outcome|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses.
1158676|NCT00414440|O1|Outcome|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
1158677|NCT00414440|O2|Outcome|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses.
1158678|NCT00414440|O1|Outcome|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
1158679|NCT00414440|O2|Outcome|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses.
1158680|NCT00414440|O1|Outcome|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
1158681|NCT00414440|O2|Outcome|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses.
1158682|NCT00414440|O1|Outcome|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
1158683|NCT00414440|E2|Reported Event|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses
1158684|NCT00414440|E1|Reported Event|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
1158685|NCT00414388|B1|Baseline|Single Agent Sorafenib|Oral Single agent Sorafenib 400mg twice daily
1158686|NCT00414388|P1|Participant Flow|Single Agent Sorafenib|Eligible patients were continued on the same chemotherapeutic regimen they had progressed on prior on entry into the study (docetaxel or mitoxantrone) with the addition of Sorafenib at 400mg twice daily. Docetaxel was given at 75 mg/m^2 and mitoxantrone was given at 12 mg/m^2, both once every 21 days and both combined with prednisone at 5mg twice daily. A maximum of 6 cycles of sorafenib plus chemotherapy were allowed. Patients without objective disease progression after combination therapy was complete were allowed to receive sorafenib monotherapy until disease progression.
1158687|NCT00414388|O1|Outcome|Sorafenib|Eligible patients were continued on the same chemotherapeutic regimen they had progressed on prior on entry into the study (Docetaxel or Mitoxantrone) with the addition of Sorafenib at 400mg twice daily. Docetaxel was given at 75 mg/m2 and Mitoxantrone was given at 12 mg/m2, both once every 21 days and both combined with Prednisone at 5mg twice daily. A maximum of 6 cycles of Sorafenib plus chemotherapy were allowed. Patients without objective disease progression after combination therapy was complete were allowed to receive Sorafenib monotherapy until disease progression.
1158688|NCT00414388|O1|Outcome|Single Agent Sorafenib|Oral Single agent Sorafenib 400mg twice daily
1158689|NCT00414388|O1|Outcome|Single Agent Sorafenib|Oral Single agent Sorafenib 400mg twice daily
1158690|NCT00414388|E1|Reported Event|Single Agent Sorafenib|Oral Single agent Sorafenib 400mg twice daily
1158691|NCT00414310|B3|Baseline|Total|Total of all reporting groups
1158692|NCT00414310|B2|Baseline|Decitabine + Valproic Acid|Decitabine 20 mg/m^2 IV over 1 hour daily for 5 days. Valproic Acid 50 mg/kg orally daily for 7 days.
1158693|NCT00414310|B1|Baseline|Decitabine|Decitabine 20 mg/m^2 intravenous (IV) over 1 hour daily for 5 days.
1158694|NCT00414310|P2|Participant Flow|Decitabine + Valproic Acid|Decitabine 20 mg/m^2 IV over 1 hour daily for 5 days. Valproic Acid 50 mg/kg orally daily for 7 days.
1158695|NCT00414310|P1|Participant Flow|Decitabine|Decitabine 20 mg/m^2 intravenous (IV) over 1 hour daily for 5 days.
1158696|NCT00414310|O2|Outcome|Decitabine + Valproic Acid|Decitabine 20 mg/m^2 IV over 1 hour daily for 5 days. Valproic Acid 50 mg/kg orally daily for 7 days.
1158697|NCT00414310|O1|Outcome|Decitabine|Decitabine 20 mg/m^2 intravenous (IV) over 1 hour daily for 5 days.
1158698|NCT00414310|E2|Reported Event|Decitabine + Valproic Acid|Decitabine 20 mg/m^2 IV over 1 hour daily for 5 days. Valproic Acid 50 mg/kg orally daily for 7 days.
1158699|NCT00414310|E1|Reported Event|Decitabine|Decitabine 20 mg/m^2 intravenous (IV) over 1 hour daily for 5 days.
1158700|NCT00414206|B4|Baseline|Total|Total of all reporting groups
1158701|NCT00414206|B3|Baseline|Placebo|
1158702|NCT00414206|B2|Baseline|0.3% Mecamylamine|
1158717|NCT00414167|P1|Participant Flow|Bupropion (300 mg/d)|"Bupropion~bupropion : 300 mg per day for 8 weeks"
1158718|NCT00414167|O2|Outcome|Placebo|"Placebo~Placebo : Placebo"
1158719|NCT00414167|O1|Outcome|Bupropion|"Bupropion~bupropion : 300 mg per day for 8 weeks"
1158720|NCT00414167|O2|Outcome|Placebo|
1158721|NCT00414167|O1|Outcome|Bupropion|
1158722|NCT00414167|E2|Reported Event|Placebo|
1158723|NCT00414167|E1|Reported Event|Bupropion|
1158724|NCT00414050|B5|Baseline|Total|Total of all reporting groups
1158726|NCT00414050|B3|Baseline|Modified Process Hepatitis B Vaccine 10 µg|Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.
1158727|NCT00414050|B2|Baseline|RECOMBIVAX™ Hepatitis B Vaccine|Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.
1158728|NCT00414050|B1|Baseline|Modified Process Hepatitis B Vaccine 5 µg (Micrograms)|Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.
1158729|NCT00414050|P4|Participant Flow|ENGERIX-B®|Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.
1158730|NCT00414050|P3|Participant Flow|Modified Process Hepatitis B Vaccine 10 µg|Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.
1158731|NCT00414050|P2|Participant Flow|RECOMBIVAX™ Hepatitis B Vaccine|Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.
1158732|NCT00414050|P1|Participant Flow|Modified Process Hepatitis B Vaccine 5 µg (Micrograms)|Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.
1158733|NCT00414050|O4|Outcome|ENGERIX-B®|Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.
1158734|NCT00414050|O3|Outcome|Modified Process Hepatitis B Vaccine 10 µg|Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.
1158735|NCT00414050|O2|Outcome|RECOMBIVAX™ Hepatitis B Vaccine|Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.
1158736|NCT00414050|O1|Outcome|Modified Process Hepatitis B Vaccine 5 µg (Micrograms)|Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.
1158737|NCT00414050|O4|Outcome|ENGERIX-B®|Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.
1158738|NCT00414050|O3|Outcome|Modified Process Hepatitis B Vaccine 10 µg|Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.
1158739|NCT00414050|O2|Outcome|RECOMBIVAX™ Hepatitis B Vaccine|Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.
1158740|NCT00414050|O1|Outcome|Modified Process Hepatitis B Vaccine 5 µg (Micrograms)|Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.
1158741|NCT00414050|E4|Reported Event|ENGERIX-B®|Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.
1158742|NCT00414050|E3|Reported Event|Modified Process Hepatitis B Vaccine 10 µg|Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.
1158743|NCT00414050|E2|Reported Event|RECOMBIVAX™ Hepatitis B Vaccine|Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.
1158744|NCT00414050|E1|Reported Event|Modified Process Hepatitis B Vaccine 5 µg (Micrograms)|Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.
1158745|NCT00414011|B1|Baseline|Moxifloxacin/Gatifloxacin Treatment|"Both eyes were treated. Each participant was randomly assigned to either:~Group A: Moxifloxacin eyedrops on right eye; Gatifloxacin eyedrops on left eye~Group B: Gatifloxacin eyedrops on right eye; Moxifloxacin eyedrops on left eye~Eyedrops were given as 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery"
1158746|NCT00414011|P1|Participant Flow|Moxifloxacin/Gatifloxacin Treatment|"Both eyes were treated. Each participant was randomly assigned to either:~Group A: Moxifloxacin eyedrops on right eye; Gatifloxacin eyedrops on left eye~Group B: Gatifloxacin eyedrops on right eye; Moxifloxacin eyedrops on left eye~Eyedrops were given as 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery"
1158747|NCT00414011|O2|Outcome|Gatifloxacin|Gatifloxacin eye drops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
1158748|NCT00414011|O1|Outcome|Moxifloxacin|Moxifloxacin eyedrops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
1158749|NCT00414011|E1|Reported Event|Adverse Events Not Collected|Adverse Events Not Collected
1158750|NCT00413972|B5|Baseline|Total|Total of all reporting groups
1158751|NCT00413972|B4|Baseline|Placebo|
1158752|NCT00413972|B3|Baseline|Vytorin 10/40|Ezetimibe 10 mg with Simvastatin 40 mg
1158753|NCT00413972|B2|Baseline|Vytorin 10/20|Ezetimibe 10 mg with Simvastatin 20 mg
1158754|NCT00413972|B1|Baseline|Vytorin 10/10|Ezetimibe 10 mg with Simvastatin 10 mg
1158755|NCT00413972|P4|Participant Flow|Placebo|
1158756|NCT00413972|P3|Participant Flow|Vytorin 10/40|Ezetimibe 10 mg with Simvastatin 40 mg
1158757|NCT00413972|P2|Participant Flow|Vytorin 10/20|Ezetimibe 10 mg with Simvastatin 20 mg
1158758|NCT00413972|P1|Participant Flow|Vytorin 10/10|Ezetimibe 10 mg with Simvastatin 10 mg
1158759|NCT00413972|O4|Outcome|Placebo|
1158760|NCT00413972|O3|Outcome|Vytorin 10/40|Ezetimibe 10 mg with Simvastatin 40 mg
1158761|NCT00413972|O2|Outcome|Vytorin 10/20|Ezetimibe 10 mg with Simvastatin 20 mg
1158762|NCT00413972|O1|Outcome|Vytorin 10/10|Ezetimibe 10 mg with Simvastatin 10 mg
1158763|NCT00413972|E4|Reported Event|Placebo|
1158764|NCT00413972|E3|Reported Event|Vytorin 10/40|Ezetimibe 10 mg with Simvastatin 40 mg
1158765|NCT00413972|E2|Reported Event|Vytorin 10/20|Ezetimibe 10 mg with Simvastatin 20 mg
1158766|NCT00413972|E1|Reported Event|Vytorin 10/10|Ezetimibe 10 mg with Simvastatin 10 mg
1163303|NCT00402987|O3|Outcome|Placebo|
1158767|NCT00413959|B1|Baseline|Velcade, Rituximab,Cyclophosphamide & Decadron|Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
1158768|NCT00413959|P1|Participant Flow|Velcade, Rituximab,Cyclophosphamide & Decadron|Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
1158769|NCT00413959|O1|Outcome|Velcade, Rituximab,Cyclophosphamide & Decadron|Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
1163383|NCT00402987|O2|Outcome|Celecoxib 100 mg (Pooled)|
1158770|NCT00413959|O1|Outcome|Velcade, Rituximab,Cyclophosphamide & Decadron|Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
1158771|NCT00413959|E1|Reported Event|Velcade, Rituximab,Cyclophosphamide & Decadron|Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
1158772|NCT00413920|B3|Baseline|Total|Total of all reporting groups
1158773|NCT00413920|B2|Baseline|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
1158774|NCT00413920|B1|Baseline|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
1158775|NCT00413920|P2|Participant Flow|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
1158776|NCT00413920|P1|Participant Flow|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
1158777|NCT00413920|O1|Outcome|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
1158778|NCT00413920|O2|Outcome|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
1158779|NCT00413920|O1|Outcome|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
1158780|NCT00413920|O2|Outcome|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
1158781|NCT00413920|O1|Outcome|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
1158782|NCT00413920|O2|Outcome|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
1158783|NCT00413920|O1|Outcome|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
1158784|NCT00413920|O2|Outcome|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
1158785|NCT00413920|O1|Outcome|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
1158786|NCT00413920|O2|Outcome|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
1158787|NCT00413920|O1|Outcome|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
1158788|NCT00413920|E2|Reported Event|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
1158789|NCT00413920|E1|Reported Event|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
1158826|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158830|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
1163304|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
1158790|NCT00413894|B1|Baseline|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
1158803|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
1158791|NCT00413894|P1|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta (C.E.R.A)|During screening (Month -2 to -1), participants received their previous ESA (Erythropoiesis Stimulating Agent) (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 micrograms per month (μg/month) administered once monthly intravenously (IV). Doses were subsequently adjusted by investigator according to participant’s hemoglobin (Hb) values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
1158792|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
1158793|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
1158794|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received methoxy polyethylene glycol-epoetin beta once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
1158795|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
1158796|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
1158797|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A monthly administered IV at a dose decided by investigator according to participant’s Hb values.
1158798|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
1158799|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
1158800|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
1158827|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
1158801|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received methoxy C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
1158802|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received methoxy C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
1158832|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1158804|NCT00413894|E1|Reported Event|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received methoxy polyethylene glycol-epoetin beta once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
1158805|NCT00413660|B8|Baseline|Total|Total of all reporting groups
1158806|NCT00413660|B7|Baseline|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
1158807|NCT00413660|B6|Baseline|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
1158808|NCT00413660|B5|Baseline|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
1158809|NCT00413660|B4|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
1158810|NCT00413660|B3|Baseline|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
1158811|NCT00413660|B2|Baseline|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1158812|NCT00413660|B1|Baseline|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1158813|NCT00413660|P11|Participant Flow|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158814|NCT00413660|P10|Participant Flow|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158815|NCT00413660|P9|Participant Flow|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158816|NCT00413660|P8|Participant Flow|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158817|NCT00413660|P7|Participant Flow|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
1158818|NCT00413660|P6|Participant Flow|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
1158819|NCT00413660|P5|Participant Flow|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
1158820|NCT00413660|P4|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
1158821|NCT00413660|P3|Participant Flow|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
1158822|NCT00413660|P2|Participant Flow|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1158823|NCT00413660|P1|Participant Flow|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1158824|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158825|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
1158831|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158861|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
1158862|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
1158833|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158834|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1158835|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158836|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
1158837|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158838|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
1158839|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
1158840|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
1158841|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
1158842|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158843|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1158844|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158845|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1158846|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158847|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
1158848|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158849|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
1158850|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
1158851|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
1158852|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
1158853|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158854|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1158855|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158856|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1158857|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158858|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
1158859|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158860|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
1163384|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1158863|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
1158864|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158865|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1158866|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158867|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1158868|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158869|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
1158870|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158871|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
1158872|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
1158873|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
1158874|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
1158875|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158876|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1158877|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158878|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1158879|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158880|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
1158881|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158882|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
1158883|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
1158884|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
1158885|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
1158886|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158887|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1158888|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158889|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1159006|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
1158890|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158891|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
1158892|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158893|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
1158894|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
1158895|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
1158896|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
1158897|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158898|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1158899|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158900|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1158901|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158902|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
1158903|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158904|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
1158905|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
1158906|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
1158907|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
1158908|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158909|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1158910|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158911|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1158912|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158913|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
1158914|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158915|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
1158916|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
1158917|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
1158918|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
1158919|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158920|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1158921|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158922|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1158923|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158924|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
1158925|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158926|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
1158927|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
1158928|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
1158929|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
1158930|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158931|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1158932|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158933|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1158934|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158935|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
1158936|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158937|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
1158938|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
1158939|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
1158940|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
1158941|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158942|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1158943|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158944|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1158945|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158946|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
1158947|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159092|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
1158948|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
1158949|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
1158950|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
1163385|NCT00402987|O3|Outcome|Placebo|
1158951|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
1158952|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158953|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1158954|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158955|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1158956|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158957|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
1158958|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158959|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
1158960|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
1158961|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
1158962|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
1158963|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158964|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1158965|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158966|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1158967|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158968|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
1158969|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158970|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
1158971|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
1158972|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
1158973|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
1158974|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158975|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1158976|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159093|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
1159094|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
1158977|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1158978|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158979|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
1158980|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158981|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
1158982|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
1158983|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
1158984|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
1158985|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158986|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1158987|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158988|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1158989|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158990|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
1158991|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158992|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
1158993|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
1158994|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
1158995|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
1158996|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158997|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1158998|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1158999|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1159000|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159001|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
1159002|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159003|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
1159004|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
1159005|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
1163305|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1159007|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159008|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1159009|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159010|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1159011|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159012|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
1159013|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159014|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
1159015|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
1159016|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
1159017|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
1159018|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159019|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1159020|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159021|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1159022|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159023|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
1159024|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159025|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
1159026|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
1159027|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
1159028|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
1159029|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159030|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1159031|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159032|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1159033|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159034|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
1159203|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
1159035|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159036|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
1159037|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
1159038|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
1163386|NCT00402987|O2|Outcome|Celecoxib 100 mg (Pooled)|
1159039|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
1159040|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159041|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1159042|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159043|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1159044|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159045|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
1159046|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159047|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
1159048|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
1159049|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
1159050|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
1159051|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159052|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1159053|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159054|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1159055|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159056|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
1159057|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159058|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
1159059|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
1159060|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
1159061|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
1159062|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159063|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1159204|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
1159205|NCT00413634|E2|Reported Event|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
1159064|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159065|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1159066|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159067|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
1159068|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159069|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
1159070|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
1159071|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
1159072|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
1159073|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159074|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1159075|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159076|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1159077|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159078|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
1159079|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159080|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
1159081|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
1159082|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
1159083|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
1159084|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159085|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1159086|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159087|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1159088|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159089|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
1159090|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159091|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
1163306|NCT00402987|O4|Outcome|Placebo|
1159095|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159096|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1159097|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159098|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1159099|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159100|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
1159101|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159102|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
1159103|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
1159104|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
1159105|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
1159106|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159107|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1159108|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159109|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1159110|NCT00413660|O7|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
1159111|NCT00413660|O6|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
1159112|NCT00413660|O5|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
1159113|NCT00413660|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
1159114|NCT00413660|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
1159115|NCT00413660|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1159116|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1159117|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159118|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
1159119|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159120|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
1159121|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
1159122|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
1159123|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
1159206|NCT00413634|E1|Reported Event|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
1159124|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159125|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1159126|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159215|NCT00413582|O1|Outcome|Epidural Group|Epidural analgesia arm of study
1159127|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1159128|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159129|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
1159130|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159131|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
1159132|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
1159133|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
1159134|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
1159135|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159136|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1159137|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159138|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1159139|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159140|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
1159141|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159142|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
1159143|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
1159144|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
1159145|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
1159146|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159147|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1159148|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159149|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1159150|NCT00413660|O7|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
1159207|NCT00413582|B3|Baseline|Total|Total of all reporting groups
1159208|NCT00413582|B2|Baseline|PCA Group|IV narcotic analgesia arm of study
1159209|NCT00413582|B1|Baseline|Epidural Group|Epidural analgesia arm of study
1159151|NCT00413660|O6|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
1159152|NCT00413660|O5|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
1159153|NCT00413660|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
1159154|NCT00413660|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
1159155|NCT00413660|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
1159216|NCT00413582|E2|Reported Event|PCA Group|IV narcotic analgesia arm of study
1159156|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
1159157|NCT00413660|E11|Reported Event|Placebo to CP-690,550 5 mg (R)|Matching placebo tablet orally twice daily up to Week 12 followed by CP-690,550 5 mg tablet orally twice up to Week 24.
1159158|NCT00413660|E10|Reported Event|Placebo|Matching placebo tablet orally twice daily up to Week 24.
1159159|NCT00413660|E9|Reported Event|CP-690,550 20 mg to CP-690,550 5 mg (R)|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose up to Week 12 followed by CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159160|NCT00413660|E8|Reported Event|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose up to Week 24.
1159161|NCT00413660|E7|Reported Event|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24.
1159162|NCT00413660|E6|Reported Event|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24.
1159163|NCT00413660|E5|Reported Event|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24.
1159164|NCT00413660|E4|Reported Event|CP-690,550 3 mg to CP-690,550 5 mg (R)|CP-690,550 3 mg tablet orally twice daily up to Week 12 followed by CP-690,550 5 mg tablet orally twice up to Week 24.
1159165|NCT00413660|E3|Reported Event|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24.
1159166|NCT00413660|E2|Reported Event|CP-690,550 1 mg to CP-690,550 5 mg (R)|CP-690,550 1 mg tablet orally twice daily up to Week 12 followed by CP-690,550 5 mg tablet orally twice up to Week 24.
1159167|NCT00413660|E1|Reported Event|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24.
1159168|NCT00413634|B3|Baseline|Total|Total of all reporting groups
1159169|NCT00413634|B2|Baseline|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
1159170|NCT00413634|B1|Baseline|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
1159171|NCT00413634|P2|Participant Flow|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
1159172|NCT00413634|P1|Participant Flow|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
1159173|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
1159174|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
1159175|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
1159176|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
1159177|NCT00413634|O2|Outcome|Agrylin (Elderly)|Active metabolite of Agrylin (BCH24426) in ages 65 and older
1159178|NCT00413634|O1|Outcome|Agrylin (Young)|Active metabolite of Agrylin (BCH24426) in ages 18-50
1159179|NCT00413634|O2|Outcome|Agrylin (Elderly)|Active metabolite of Agrylin (BCH24426) in ages 65 and older
1159180|NCT00413634|O1|Outcome|Agrylin (Young)|Active metabolite of Agrylin (BCH24426) in ages 18-50
1159181|NCT00413634|O2|Outcome|Agrylin (Elderly)|Active metabolite of Agrylin (BCH24426) in ages 65 and older
1159182|NCT00413634|O1|Outcome|Agrylin (Young)|Active metabolite of Agrylin (BCH24426) in ages 18-50
1159183|NCT00413634|O2|Outcome|Agrylin (Elderly)|Active metabolite of Agrylin (BCH24426) in ages 65 and older
1159184|NCT00413634|O1|Outcome|Agrylin (Young)|Active metabolite of Agrylin (BCH24426) in ages 18-50
1159185|NCT00413634|O2|Outcome|Agrylin (Elderly)|Active metabolite of Agrylin (BCH24426) in ages 65 and older
1159186|NCT00413634|O1|Outcome|Agrylin (Young)|Active metabolite of Agrylin (BCH24426) in ages 18-50
1159187|NCT00413634|O2|Outcome|Agrylin (Elderly)|Active metabolite of Agrylin (BCH24426) in ages 65 and older
1159188|NCT00413634|O1|Outcome|Agrylin (Young)|Active metabolite of Agrylin (BCH24426) in ages 18-50
1159189|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
1159190|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
1159191|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
1159192|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
1159193|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
1159194|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
1159195|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
1159196|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
1159197|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
1159198|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
1159199|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
1159200|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
1159201|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
1159202|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
1159210|NCT00413582|P2|Participant Flow|PCA Group|IV narcotic analgesia arm of study
1159211|NCT00413582|P1|Participant Flow|Epidural Group|Epidural analgesia arm of study
1159212|NCT00413582|O2|Outcome|PCA Group|IV narcotic analgesia arm of study
1159213|NCT00413582|O1|Outcome|Epidural Group|Epidural analgesia arm of study
1159214|NCT00413582|O2|Outcome|PCA Group|IV narcotic analgesia arm of study
1159217|NCT00413582|E1|Reported Event|Epidural Group|Epidural analgesia arm of study
1159218|NCT00413478|B1|Baseline|5-Azacytidine|5-Azacytidine 75 mg/m^2 subcutaneously daily for 7 days, cycle repeated every 3-8 weeks.
1159219|NCT00413478|P1|Participant Flow|5-Azacytidine|5-Azacytidine 75 mg/m^2 subcutaneously daily for 7 days, cycle repeated every 3-8 weeks.
1159220|NCT00413478|O1|Outcome|5-Azacytidine|5-Azacytidine 75 mg/m^2 subcutaneously daily for 7 days, cycle repeated every 3-8 weeks.
1159221|NCT00413478|E1|Reported Event|5-Azacytidine|5-Azacytidine 75 mg/m^2 subcutaneously daily for 7 days, cycle repeated every 3-8 weeks.
1159222|NCT00413413|B4|Baseline|Total|Total of all reporting groups
1159223|NCT00413413|B3|Baseline|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
1159224|NCT00413413|B2|Baseline|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
1159225|NCT00413413|B1|Baseline|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
1159226|NCT00413413|P3|Participant Flow|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
1159227|NCT00413413|P2|Participant Flow|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
1159228|NCT00413413|P1|Participant Flow|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
1159229|NCT00413413|O3|Outcome|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
1159230|NCT00413413|O2|Outcome|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
1159231|NCT00413413|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
1159232|NCT00413413|O3|Outcome|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
1159233|NCT00413413|O2|Outcome|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
1159234|NCT00413413|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
1159235|NCT00413413|O3|Outcome|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
1159236|NCT00413413|O2|Outcome|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
1159237|NCT00413413|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
1159238|NCT00413413|O3|Outcome|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
1159239|NCT00413413|O2|Outcome|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
1159240|NCT00413413|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
1159241|NCT00413413|O3|Outcome|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
1159242|NCT00413413|O2|Outcome|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
1159243|NCT00413413|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
1159244|NCT00413413|E3|Reported Event|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
1159245|NCT00413413|E2|Reported Event|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
1159246|NCT00413413|E1|Reported Event|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
1159247|NCT00413400|B3|Baseline|Total|Total of all reporting groups
1159248|NCT00413400|B2|Baseline|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
1159249|NCT00413400|B1|Baseline|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
1159250|NCT00413400|P2|Participant Flow|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
1159251|NCT00413400|P1|Participant Flow|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
1159252|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
1159253|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
1159254|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
1159255|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
1159256|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
1159257|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
1159258|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
1159259|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
1159260|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
1159261|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
1159262|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
1159263|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
1159264|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
1159265|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
1159266|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
1159267|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
1159268|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
1159269|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
1159270|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
1159271|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
1159272|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
1159273|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
1159274|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
1159275|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
1159276|NCT00413400|E2|Reported Event|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
1159277|NCT00413400|E1|Reported Event|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
1159278|NCT00413374|B1|Baseline|Enoxaparin|"Recieved low molecular weight heparin (LMWH) as a bridge to warfarin"
1159279|NCT00413374|P1|Participant Flow|Enoxaparin|"Recieved low molecular weight heparin (LMWH) as a bridge to warfarin"
1159280|NCT00413374|O1|Outcome|Recurrent Venous Thromboembolism|Participants receiving Enoxaparin once daily who developed a VTE (either a DVT or PE) within 30 days.
1159281|NCT00413374|O1|Outcome|Major Bleeding Complication|Study participants receiving Enoxaparin once daily who developed a major bleeding complication within 30 days.
1159282|NCT00413374|E1|Reported Event|Enoxaparin|"Recieved low molecular weight heparin (LMWH) as a bridge to warfarin"
1159283|NCT00413335|B3|Baseline|Total|Total of all reporting groups
1159284|NCT00413335|B2|Baseline|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.~Placebo : Subject receives placebo."
1159285|NCT00413335|B1|Baseline|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.~Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
1159286|NCT00413335|P2|Participant Flow|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.~Placebo : Subject receives placebo."
1159287|NCT00413335|P1|Participant Flow|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.~Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
1159288|NCT00413335|O2|Outcome|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.~Placebo : Subject receives placebo."
1159289|NCT00413335|O1|Outcome|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.~Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
1159290|NCT00413335|O2|Outcome|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.~Placebo : Subject receives placebo."
1159291|NCT00413335|O1|Outcome|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.~Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
1159292|NCT00413335|O2|Outcome|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.~Placebo : Subject receives placebo."
1159293|NCT00413335|O1|Outcome|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.~Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
1159294|NCT00413335|O2|Outcome|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.~Placebo : Subject receives placebo."
1159295|NCT00413335|O1|Outcome|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.~Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
1159521|NCT00413036|E1|Reported Event|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
1159296|NCT00413335|O2|Outcome|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.~Placebo : Subject receives placebo."
1159374|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
1159297|NCT00413335|O1|Outcome|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.~Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
1159298|NCT00413335|E2|Reported Event|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.~Placebo : Subject receives placebo."
1159299|NCT00413335|E1|Reported Event|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.~Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
1159300|NCT00413283|B5|Baseline|Total|Total of all reporting groups
1159301|NCT00413283|B4|Baseline|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159302|NCT00413283|B3|Baseline|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159303|NCT00413283|B2|Baseline|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159304|NCT00413283|B1|Baseline|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159305|NCT00413283|P4|Participant Flow|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159306|NCT00413283|P3|Participant Flow|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159307|NCT00413283|P2|Participant Flow|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159308|NCT00413283|P1|Participant Flow|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159309|NCT00413283|O4|Outcome|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159310|NCT00413283|O3|Outcome|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159311|NCT00413283|O2|Outcome|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159312|NCT00413283|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159313|NCT00413283|O4|Outcome|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159314|NCT00413283|O3|Outcome|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159315|NCT00413283|O2|Outcome|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159316|NCT00413283|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159317|NCT00413283|O4|Outcome|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159318|NCT00413283|O3|Outcome|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159319|NCT00413283|O2|Outcome|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159320|NCT00413283|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159321|NCT00413283|O4|Outcome|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159322|NCT00413283|O3|Outcome|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159323|NCT00413283|O2|Outcome|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159324|NCT00413283|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159325|NCT00413283|O4|Outcome|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159326|NCT00413283|O3|Outcome|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159327|NCT00413283|O2|Outcome|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159370|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
1159522|NCT00413010|B3|Baseline|Total|Total of all reporting groups
1159328|NCT00413283|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159375|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
1159376|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
1159329|NCT00413283|O4|Outcome|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159330|NCT00413283|O3|Outcome|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159331|NCT00413283|O2|Outcome|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159332|NCT00413283|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159333|NCT00413283|E4|Reported Event|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159334|NCT00413283|E3|Reported Event|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159335|NCT00413283|E2|Reported Event|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159336|NCT00413283|E1|Reported Event|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
1159337|NCT00413244|B3|Baseline|Total|Total of all reporting groups
1159338|NCT00413244|B2|Baseline|Placebo|Matching Placebo
1159339|NCT00413244|B1|Baseline|Androgel|Androgel 5 grams
1159340|NCT00413244|P2|Participant Flow|Placebo|Matching Placebo
1159341|NCT00413244|P1|Participant Flow|Androgel|Androgel 5 grams
1159342|NCT00413244|O2|Outcome|Placebo|Matching Placebo
1159343|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
1159344|NCT00413244|O2|Outcome|Placebo|Matching Placebo
1159345|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
1159346|NCT00413244|O2|Outcome|Placebo|Matching Placebo
1159347|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
1159348|NCT00413244|O2|Outcome|Placebo|Matching Placebo
1159349|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
1159350|NCT00413244|O2|Outcome|Placebo|Matching Placebo
1159351|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
1159352|NCT00413244|O2|Outcome|Placebo|Matching Placebo
1159353|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
1159354|NCT00413244|O2|Outcome|Placebo|Matching Placebo
1159355|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
1159356|NCT00413244|O2|Outcome|Placebo|Matching Placebo
1159357|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
1159358|NCT00413244|O2|Outcome|Placebo|Matching Placebo
1159359|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
1159360|NCT00413244|O2|Outcome|Placebo|Matching Placebo
1159361|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
1159362|NCT00413244|O2|Outcome|Placebo|Matching Placebo
1159363|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
1159364|NCT00413244|O2|Outcome|Placebo|Matching Placebo
1159365|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
1159366|NCT00413244|E2|Reported Event|Placebo|Matching Placebo
1159367|NCT00413244|E1|Reported Event|Androgel|Androgel 5 grams
1159368|NCT00413231|B1|Baseline|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
1159369|NCT00413231|P1|Participant Flow|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
1159371|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
1159372|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
1159373|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
1159610|NCT00412958|P1|Participant Flow|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injection.
1159377|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
1159378|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
1159379|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
1159380|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
1159381|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
1159382|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
1159383|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
1159384|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
1159385|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
1159386|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
1159387|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
1159388|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
1159389|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
1159390|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
1159391|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
1159392|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
1159393|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
1159394|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
1159395|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|"160 subjects were enrolled into the study, including 157 subjects treated with the study device and three subjects classified as intent-to-treat who did not receive the study device.~There were no other arms for this study.~Valiant Thoracic Stent Graft System: Surgical procedure in which a device is implanted inside the aorta, isolating the diseased area (aneurysm)."
1159396|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
1159397|NCT00413231|E1|Reported Event|Valiant Thoracic Stent Graft System|"160 subjects were enrolled into the study, including 157 subjects treated with the study device and three subjects classified as intent-to-treat who did not receive the study device.~There were no other arms for this study."
1159398|NCT00413192|B5|Baseline|Total|Total of all reporting groups
1159399|NCT00413192|B4|Baseline|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159400|NCT00413192|B3|Baseline|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159401|NCT00413192|B2|Baseline|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159402|NCT00413192|B1|Baseline|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159403|NCT00413192|P4|Participant Flow|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159518|NCT00413036|O1|Outcome|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
1159519|NCT00413036|O1|Outcome|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
1159404|NCT00413192|P3|Participant Flow|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159474|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1159611|NCT00412958|O4|Outcome|Placebo|Intravitreal injection of placebo.
1159405|NCT00413192|P2|Participant Flow|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159406|NCT00413192|P1|Participant Flow|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159407|NCT00413192|O4|Outcome|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159408|NCT00413192|O3|Outcome|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159409|NCT00413192|O2|Outcome|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159410|NCT00413192|O1|Outcome|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159411|NCT00413192|O4|Outcome|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159412|NCT00413192|O3|Outcome|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159413|NCT00413192|O2|Outcome|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159414|NCT00413192|O1|Outcome|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159415|NCT00413192|O4|Outcome|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159416|NCT00413192|O3|Outcome|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159417|NCT00413192|O2|Outcome|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159418|NCT00413192|O1|Outcome|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1163307|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
1159419|NCT00413192|O4|Outcome|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159420|NCT00413192|O3|Outcome|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159421|NCT00413192|O2|Outcome|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159422|NCT00413192|O1|Outcome|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159423|NCT00413192|O4|Outcome|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159424|NCT00413192|O3|Outcome|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159425|NCT00413192|O2|Outcome|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159426|NCT00413192|O1|Outcome|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159427|NCT00413192|O4|Outcome|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159428|NCT00413192|O3|Outcome|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159429|NCT00413192|O2|Outcome|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159430|NCT00413192|O1|Outcome|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159431|NCT00413192|O4|Outcome|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159432|NCT00413192|O3|Outcome|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159433|NCT00413192|O2|Outcome|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159434|NCT00413192|O1|Outcome|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1163308|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
1159435|NCT00413192|O4|Outcome|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159436|NCT00413192|O3|Outcome|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159592|NCT00412971|B1|Baseline|Hexvix Cystoscopy Group|
1159437|NCT00413192|O2|Outcome|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159438|NCT00413192|O1|Outcome|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159439|NCT00413192|E4|Reported Event|Other Types of Sarcoma (OTH)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159440|NCT00413192|E3|Reported Event|Synovial Sarcoma (SYN)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159441|NCT00413192|E2|Reported Event|Leiomyosarcoma (LMS)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatmeDnt period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159442|NCT00413192|E1|Reported Event|Adipocyte Tumors (ADI)|Participants were administered 1.4 mg/m^2 eribulin mesilate by intravenous (IV) bolus infusion over 2 to 5 minutes on Days 1 and 8 every 21 days (21 Days = 1 Cycle) for as long as clinical benefit was sustained. The dose of study drug could have been reduced or discontinued during any treatment period, in accordance with toxicity modifications. Once the dose was reduced, it could not be increased at a later date.
1159443|NCT00413153|B3|Baseline|Total|Total of all reporting groups
1159444|NCT00413153|B2|Baseline|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
1159445|NCT00413153|B1|Baseline|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
1159446|NCT00413153|P2|Participant Flow|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
1159447|NCT00413153|P1|Participant Flow|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
1159448|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
1159449|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
1159450|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
1159451|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
1159452|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
1159453|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
1159454|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
1159455|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
1159456|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
1159457|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
1159458|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
1159459|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
1159460|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
1159461|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
1159462|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
1159463|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
1159464|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
1159465|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
1159466|NCT00413153|E2|Reported Event|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
1159467|NCT00413153|E1|Reported Event|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
1159468|NCT00413062|B3|Baseline|Total|Total of all reporting groups
1159469|NCT00413062|B2|Baseline|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1159470|NCT00413062|B1|Baseline|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1159520|NCT00413036|O1|Outcome|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
1159471|NCT00413062|P2|Participant Flow|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1159472|NCT00413062|P1|Participant Flow|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1159473|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1159593|NCT00412971|P2|Participant Flow|White Light|Standard White light cystoscopy
1159475|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1159476|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1159477|NCT00413062|O2|Outcome|DRSP-EE|"Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).~n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
1159478|NCT00413062|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).~n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
1159479|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1159480|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1159481|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1159482|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1159483|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1159484|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1159485|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1159486|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1159487|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1159488|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1159489|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1159490|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1159491|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1159492|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1163309|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1159493|NCT00413062|E2|Reported Event|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1159494|NCT00413062|E1|Reported Event|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
1159495|NCT00413049|B3|Baseline|Total|Total of all reporting groups
1159496|NCT00413049|B2|Baseline|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
1159594|NCT00412971|P1|Participant Flow|Hexvix Cystoscopy Group|
1159497|NCT00413049|B1|Baseline|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
1159498|NCT00413049|P2|Participant Flow|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
1159499|NCT00413049|P1|Participant Flow|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
1159500|NCT00413049|O2|Outcome|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
1159501|NCT00413049|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
1159502|NCT00413049|O2|Outcome|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
1159503|NCT00413049|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
1159504|NCT00413049|O2|Outcome|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
1159505|NCT00413049|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
1159506|NCT00413049|O2|Outcome|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
1159507|NCT00413049|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
1159508|NCT00413049|O2|Outcome|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
1159509|NCT00413049|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
1159510|NCT00413049|O2|Outcome|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
1159511|NCT00413049|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
1159512|NCT00413049|E2|Reported Event|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
1159513|NCT00413049|E1|Reported Event|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
1159514|NCT00413036|B1|Baseline|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
1159515|NCT00413036|P1|Participant Flow|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
1159516|NCT00413036|O1|Outcome|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
1159517|NCT00413036|O1|Outcome|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
1163310|NCT00402987|O3|Outcome|Placebo|
1159523|NCT00413010|B2|Baseline|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
1159595|NCT00412971|O2|Outcome|White Light|Standard White light cystoscopy
1159596|NCT00412971|O1|Outcome|Hexvix Cystoscopy Group|
1159597|NCT00412971|O1|Outcome|Hexvix Cystoscopy Group|
1159598|NCT00412971|O2|Outcome|White Light|Standard White light cystoscopy
1159599|NCT00412971|O1|Outcome|Hexvix Cystoscopy Group|
1159524|NCT00413010|B1|Baseline|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
1159525|NCT00413010|P2|Participant Flow|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
1159526|NCT00413010|P1|Participant Flow|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
1159527|NCT00413010|O2|Outcome|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
1159528|NCT00413010|O1|Outcome|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
1159529|NCT00413010|O2|Outcome|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
1159530|NCT00413010|O1|Outcome|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
1159531|NCT00413010|O2|Outcome|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
1159532|NCT00413010|O1|Outcome|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
1159533|NCT00413010|O2|Outcome|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
1159534|NCT00413010|O1|Outcome|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
1159535|NCT00413010|O2|Outcome|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
1159536|NCT00413010|O1|Outcome|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
1159537|NCT00413010|O2|Outcome|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
1159538|NCT00413010|O1|Outcome|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
1159539|NCT00413010|O2|Outcome|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
1159556|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
1159540|NCT00413010|O1|Outcome|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
1159541|NCT00413010|O2|Outcome|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
1159600|NCT00412971|E2|Reported Event|White Light|Standard White light cystoscopy
1159601|NCT00412971|E1|Reported Event|Hexvix Cystoscopy Group|
1159602|NCT00412958|B5|Baseline|Total|Total of all reporting groups
1159603|NCT00412958|B4|Baseline|Placebo|Intravitreal injection of placebo.
1159542|NCT00413010|O1|Outcome|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
1159543|NCT00413010|E2|Reported Event|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
1159544|NCT00413010|E1|Reported Event|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
1159545|NCT00412984|B3|Baseline|Total|Total of all reporting groups
1159546|NCT00412984|B2|Baseline|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
1159547|NCT00412984|B1|Baseline|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
1159548|NCT00412984|P2|Participant Flow|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
1159549|NCT00412984|P1|Participant Flow|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
1159550|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
1159551|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
1159552|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
1159553|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
1159554|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
1159555|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
1159734|NCT00412737|B1|Baseline|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
1159557|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
1159604|NCT00412958|B3|Baseline|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection.
1159605|NCT00412958|B2|Baseline|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection.
1159606|NCT00412958|B1|Baseline|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injection
1159558|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
1159559|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
1159560|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
1159561|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
1159562|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
1159563|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
1159564|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
1159565|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
1159566|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
1159567|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
1159568|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
1159569|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
1159570|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
1159571|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
1159572|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
1159607|NCT00412958|P4|Participant Flow|Placebo|Intravitreal injection of placebo.
1159608|NCT00412958|P3|Participant Flow|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection.
1159609|NCT00412958|P2|Participant Flow|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection.
1159573|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
1159574|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
1159575|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
1159576|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
1159577|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
1159578|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
1159579|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
1159580|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
1159581|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
1159582|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
1159583|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
1159584|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
1159585|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
1159586|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
1159587|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
1159588|NCT00412984|E2|Reported Event|Apixaban|
1159589|NCT00412984|E1|Reported Event|Warfarin|
1159590|NCT00412971|B3|Baseline|Total|Total of all reporting groups
1159591|NCT00412971|B2|Baseline|White Light|Standard White light cystoscopy
1159612|NCT00412958|O3|Outcome|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection.
1159613|NCT00412958|O2|Outcome|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection.
1159614|NCT00412958|O1|Outcome|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injection.
1159615|NCT00412958|E4|Reported Event|Placebo|Intravitreal injection of placebo.
1159616|NCT00412958|E3|Reported Event|Ocriplasmin 125µg|125µg of ocriplasmin intravitreal injection.
1159617|NCT00412958|E2|Reported Event|Ocriplasmin 75µg|75µg of ocriplasmin intravitreal injection.
1159618|NCT00412958|E1|Reported Event|Ocriplasmin 25µg|25µg of ocriplasmin intravitreal injection.
1159619|NCT00412932|B1|Baseline|Active Treatment Period|All participants started the active treatment period with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40 mg Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm 40 mg + HCTZ 25 mg if their blood pressure was not controlled.
1159620|NCT00412932|P1|Participant Flow|Active Treatment Period|All participants started this arm with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm 40 mg + HCTZ 25 mg if their blood pressure was not controlled.
1159621|NCT00412932|O1|Outcome|Overall Study|
1159622|NCT00412932|O1|Outcome|Overall Study|
1159623|NCT00412932|O1|Outcome|Overall Study|
1159624|NCT00412932|O1|Outcome|Overall Study|
1159625|NCT00412932|O1|Outcome|Overall Study|
1159626|NCT00412932|O1|Outcome|Overall Study|
1159627|NCT00412932|O1|Outcome|Overall Study|
1159628|NCT00412893|B3|Baseline|Total|Total of all reporting groups
1159629|NCT00412893|B2|Baseline|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
1159630|NCT00412893|B1|Baseline|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
1159631|NCT00412893|P2|Participant Flow|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
1159632|NCT00412893|P1|Participant Flow|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
1159633|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
1159634|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
1159635|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
1159636|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
1159637|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
1159638|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
1159639|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
1159662|NCT00412867|E2|Reported Event|Alteplase (Haemorrhage)|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
1159640|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
1159641|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
1159740|NCT00412737|O1|Outcome|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
1159741|NCT00412737|O2|Outcome|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
1159642|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
1159643|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
1159644|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
1159645|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
1159646|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
1159647|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
1159648|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
1159649|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
1159650|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
1159651|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
1159652|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
1159653|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
1159654|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
1159655|NCT00412893|E2|Reported Event|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
1159656|NCT00412893|E1|Reported Event|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
1159657|NCT00412867|B1|Baseline|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
1159658|NCT00412867|P1|Participant Flow|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
1159659|NCT00412867|O1|Outcome|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
1159660|NCT00412867|O1|Outcome|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
1159661|NCT00412867|O1|Outcome|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
1159732|NCT00412737|B3|Baseline|Total|Total of all reporting groups
1159663|NCT00412867|E1|Reported Event|Alteplase (Non-Haemorrhage)|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
1159664|NCT00412854|B3|Baseline|Total|Total of all reporting groups
1159665|NCT00412854|B2|Baseline|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
1159666|NCT00412854|B1|Baseline|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
1159667|NCT00412854|P2|Participant Flow|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
1159668|NCT00412854|P1|Participant Flow|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
1159669|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
1159670|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
1159671|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
1159672|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
1159673|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
1159674|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
1159675|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
1159676|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
1159677|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
1159678|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
1159679|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
1159680|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
1159681|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
1159682|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
1159683|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
1159684|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
1159685|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
1159686|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
1159687|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
1159733|NCT00412737|B2|Baseline|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
1159850|NCT00412373|B3|Baseline|Total|Total of all reporting groups
1159688|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
1159689|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
1159690|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
1159742|NCT00412737|O1|Outcome|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
1159798|NCT00412516|P3|Participant Flow|Group 3|Measles vaccine followed by SA 14-14-2 one month later
1159691|NCT00412854|E2|Reported Event|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
1159692|NCT00412854|E1|Reported Event|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
1159693|NCT00412841|B3|Baseline|Total|Total of all reporting groups
1159694|NCT00412841|B2|Baseline|Placebo|
1159695|NCT00412841|B1|Baseline|Atorvastatin|Atorvastatin 40mg
1159696|NCT00412841|P2|Participant Flow|Placebo|
1159697|NCT00412841|P1|Participant Flow|Atorvastatin|40 mg
1159698|NCT00412841|O2|Outcome|Placebo|
1159699|NCT00412841|O1|Outcome|Atorvastatin|Atorvastatin 40mg
1159700|NCT00412841|O2|Outcome|Placebo|
1159701|NCT00412841|O1|Outcome|Atorvastatin|Atorvastatin 40mg
1159702|NCT00412841|E2|Reported Event|Placebo|Placebo
1159703|NCT00412841|E1|Reported Event|Atorvastatin|Atorvastatin 40mg
1159704|NCT00412750|B4|Baseline|Total|Total of all reporting groups
1159705|NCT00412750|B3|Baseline|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
1159706|NCT00412750|B2|Baseline|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
1159707|NCT00412750|B1|Baseline|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
1159708|NCT00412750|P3|Participant Flow|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
1159709|NCT00412750|P2|Participant Flow|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
1159710|NCT00412750|P1|Participant Flow|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
1159711|NCT00412750|O3|Outcome|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
1159712|NCT00412750|O2|Outcome|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
1159713|NCT00412750|O1|Outcome|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
1159714|NCT00412750|O2|Outcome|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
1159715|NCT00412750|O1|Outcome|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
1159716|NCT00412750|O2|Outcome|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
1159717|NCT00412750|O1|Outcome|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
1159718|NCT00412750|O3|Outcome|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
1159719|NCT00412750|O2|Outcome|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
1159720|NCT00412750|O1|Outcome|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
1159721|NCT00412750|O3|Outcome|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
1159722|NCT00412750|O2|Outcome|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
1159723|NCT00412750|O1|Outcome|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
1159724|NCT00412750|O3|Outcome|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
1159725|NCT00412750|O2|Outcome|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
1159726|NCT00412750|O1|Outcome|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
1159727|NCT00412750|O2|Outcome|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
1159728|NCT00412750|O1|Outcome|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
1159729|NCT00412750|E3|Reported Event|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
1159730|NCT00412750|E2|Reported Event|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
1159731|NCT00412750|E1|Reported Event|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
1159735|NCT00412737|P2|Participant Flow|Oseltamivir|Oseltamivir 30 milligram (mg) to 75 mg capsule or suspension orally once daily for 12 weeks.
1159736|NCT00412737|P1|Participant Flow|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
1159737|NCT00412737|O2|Outcome|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
1159738|NCT00412737|O1|Outcome|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
1159739|NCT00412737|O2|Outcome|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
1159743|NCT00412737|O2|Outcome|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
1159744|NCT00412737|O1|Outcome|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
1159745|NCT00412737|O2|Outcome|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
1159746|NCT00412737|O1|Outcome|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
1159747|NCT00412737|O2|Outcome|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
1159748|NCT00412737|O1|Outcome|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
1159749|NCT00412737|O2|Outcome|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
1159750|NCT00412737|O1|Outcome|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
1159751|NCT00412737|E2|Reported Event|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
1159752|NCT00412737|E1|Reported Event|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
1159753|NCT00412607|B1|Baseline|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
1159754|NCT00412607|P1|Participant Flow|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
1159755|NCT00412607|O1|Outcome|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
1159756|NCT00412607|O3|Outcome|Reported No Recurrence|Subjects reported no recurrence of Ventricular Tachycardia (VT) at 12-month, 3-year follow-up visit
1159757|NCT00412607|O2|Outcome|Reported Recurrence|Subjects reported recurrence of Ventricular Tachycardia (VT) at 12-month, 3-year follow-up visit
1159758|NCT00412607|O1|Outcome|Total|Total number of subjects who completed 12-month, 2-year, and 3-year follow-up respectively.
1159759|NCT00412607|O1|Outcome|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
1159760|NCT00412607|O1|Outcome|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
1159761|NCT00412607|O1|Outcome|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
1159762|NCT00412607|O1|Outcome|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
1159763|NCT00412607|E1|Reported Event|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
1159764|NCT00412542|B3|Baseline|Total|Total of all reporting groups
1159765|NCT00412542|B2|Baseline|Anaplastic Gliomas: Thalidomide + CPT-11|Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.
1159766|NCT00412542|B1|Baseline|Glioblastoma Multiforme: Thalidomide + CPT-11|Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.
1159767|NCT00412542|P2|Participant Flow|Anaplastic Gliomas: Thalidomide + CPT-11|Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.
1159768|NCT00412542|P1|Participant Flow|Glioblastoma Multiforme: Thalidomide + CPT-11|Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.
1159769|NCT00412542|O1|Outcome|Participants With Recurrent Malignant Gliomas|The endpoints combined results of all strata (Arm 1 of Glioblastoma Multiforme: Thalidomide + CPT-11 and Arm 2 of Anaplastic Gliomas: Thalidomide + CPT-11).
1159770|NCT00412542|E1|Reported Event|Patients With Recurrent Malignant Gliomas|The endpoints combined results of all strata
1159771|NCT00412529|B3|Baseline|Total|Total of all reporting groups
1159772|NCT00412529|B2|Baseline|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
1159773|NCT00412529|B1|Baseline|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
1159774|NCT00412529|P2|Participant Flow|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
1159775|NCT00412529|P1|Participant Flow|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
1159776|NCT00412529|O2|Outcome|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
1159777|NCT00412529|O1|Outcome|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
1159778|NCT00412529|O2|Outcome|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
1159779|NCT00412529|O1|Outcome|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
1159780|NCT00412529|O2|Outcome|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
1159781|NCT00412529|O1|Outcome|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
1159782|NCT00412529|O2|Outcome|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
1159783|NCT00412529|O1|Outcome|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
1159784|NCT00412529|O2|Outcome|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
1159785|NCT00412529|O1|Outcome|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
1159786|NCT00412529|O2|Outcome|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
1159787|NCT00412529|O1|Outcome|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
1159788|NCT00412529|O2|Outcome|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
1159789|NCT00412529|O1|Outcome|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
1159790|NCT00412529|O2|Outcome|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
1159791|NCT00412529|O1|Outcome|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
1159792|NCT00412529|E2|Reported Event|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
1159793|NCT00412529|E1|Reported Event|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
1159794|NCT00412516|B4|Baseline|Total|Total of all reporting groups
1159795|NCT00412516|B3|Baseline|Group 3|Measles vaccine followed by SA 14-14-2 one month later
1159796|NCT00412516|B2|Baseline|Group 2|Measles and SA 14-14-2 given concurrently
1159797|NCT00412516|B1|Baseline|Group 1|SA 14-14-2 followed by measles vaccine one month later
1159799|NCT00412516|P2|Participant Flow|Group 2|"Measles and SA 14-14-2 given concurrently~Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)"
1159800|NCT00412516|P1|Participant Flow|Group 1|SA 14-14-2 followed by measles vaccine one month later
1159801|NCT00412516|O3|Outcome|Group 3|Measles vaccine followed by SA 14-14-2 one month later
1159802|NCT00412516|O2|Outcome|Group 2|"Measles and SA 14-14-2 given concurrently~Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)"
1159803|NCT00412516|O1|Outcome|Group 1|SA 14-14-2 followed by measles vaccine one month later
1159804|NCT00412516|O3|Outcome|Group 3|Measles vaccine followed by SA 14-14-2 one month later
1159805|NCT00412516|O2|Outcome|Group 2|"Measles and SA 14-14-2 given concurrently~Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)"
1159806|NCT00412516|O1|Outcome|Group 1|SA 14-14-2 followed by measles vaccine one month later
1159807|NCT00412516|O3|Outcome|Group 3|Measles vaccine followed by SA 14-14-2 one month later
1159808|NCT00412516|O2|Outcome|Group 2|"Measles and SA 14-14-2 given concurrently~Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)"
1159809|NCT00412516|O1|Outcome|Group 1|SA 14-14-2 followed by measles vaccine one month later
1159810|NCT00412516|O3|Outcome|Group 3|Measles vaccine followed by SA 14-14-2 one month later
1159811|NCT00412516|O2|Outcome|Group 2|"Measles and SA 14-14-2 given concurrently~Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)"
1159812|NCT00412516|O1|Outcome|Group 1|SA 14-14-2 followed by measles vaccine one month later
1159813|NCT00412516|E3|Reported Event|Group 3|Measles vaccine followed by SA 14-14-2 one month later
1159814|NCT00412516|E2|Reported Event|Group 2|"Measles and SA 14-14-2 given concurrently~Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)"
1159815|NCT00412516|E1|Reported Event|Group 1|SA 14-14-2 followed by measles vaccine one month later
1159816|NCT00412464|B1|Baseline|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
1159817|NCT00412464|P1|Participant Flow|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
1159818|NCT00412464|O1|Outcome|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
1159819|NCT00412464|O1|Outcome|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
1159820|NCT00412464|O1|Outcome|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
1159821|NCT00412464|O1|Outcome|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
1159822|NCT00412464|O1|Outcome|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
1159823|NCT00412464|E1|Reported Event|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
1159824|NCT00412451|B5|Baseline|Total|Total of all reporting groups
1159825|NCT00412451|B4|Baseline|Sham Injection|"Sham injection~Sham injection : Sham intravitreal injection"
1159826|NCT00412451|B3|Baseline|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection versus sham injection
1159827|NCT00412451|B2|Baseline|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection versus sham injection
1159828|NCT00412451|B1|Baseline|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injection versus sham injection
1159829|NCT00412451|P4|Participant Flow|Sham Injection|Sham intravitreal injection
1159830|NCT00412451|P3|Participant Flow|0criplasmin 125µg|125µg ocriplasmin intravitreal injection versus sham injection
1159831|NCT00412451|P2|Participant Flow|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection versus sham injection
1159832|NCT00412451|P1|Participant Flow|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injections versus sham injection
1159833|NCT00412451|O4|Outcome|Sham Injection|"Sham injection~Sham injection : Sham intravitreal injection"
1159834|NCT00412451|O3|Outcome|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection versus sham injection
1159835|NCT00412451|O2|Outcome|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection versus sham injection
1159836|NCT00412451|O1|Outcome|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injection versus sham injection
1159837|NCT00412451|E4|Reported Event|Sham Injection|"Sham injection~Sham injection : Sham intravitreal injection"
1159838|NCT00412451|E3|Reported Event|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection versus sham injection
1159839|NCT00412451|E2|Reported Event|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection versus sham injection
1159840|NCT00412451|E1|Reported Event|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injection versus sham injection
1159841|NCT00412425|B3|Baseline|Total|Total of all reporting groups
1159842|NCT00412425|B2|Baseline|2 Days Palonosetron|2 Days Palonosetron 0.25 mg IV
1159843|NCT00412425|B1|Baseline|3 Days Palonosetron|3 Days Palonosetron 0.25 mg intravenous (IV)
1159844|NCT00412425|P2|Participant Flow|2 Days Palonosetron|2 Days Palonosetron 0.25 mg IV
1159845|NCT00412425|P1|Participant Flow|3 Days Palonosetron|3 Days Palonosetron 0.25 mg intravenous (IV)
1159846|NCT00412425|O2|Outcome|2 Days Palonosetron|2 Days Palonosetron 0.25 mg IV
1159847|NCT00412425|O1|Outcome|3 Days Palonosetron|3 Days Palonosetron 0.25 mg intravenous (IV)
1159848|NCT00412425|E2|Reported Event|2 Days Palonosetron|2 Days Palonosetron 0.25 mg IV
1159849|NCT00412425|E1|Reported Event|3 Days Palonosetron|3 Days Palonosetron 0.25 mg intravenous (IV)
1159851|NCT00412373|B2|Baseline|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
1160070|NCT00411749|O2|Outcome|Placebo|Placebo vaccination 0.5 ml injection in 3 dosing regimen.
1159852|NCT00412373|B1|Baseline|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
1159853|NCT00412373|P2|Participant Flow|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
1159854|NCT00412373|P1|Participant Flow|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
1159855|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
1159856|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
1159857|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
1159858|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
1159859|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
1159860|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
1159861|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
1159862|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
1159863|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
1159864|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
1159865|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
1159866|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
1159867|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
1159868|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
1159925|NCT00412217|B2|Baseline|Placebo|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
1163311|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
1159869|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
1159870|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
1159929|NCT00412217|O2|Outcome|Placebo|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
1159871|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
1159872|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
1159873|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
1159874|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
1159875|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
1159876|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
1159877|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
1159878|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
1159879|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
1159880|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
1159881|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
1159882|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
1159883|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
1159884|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
1159885|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
1159886|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
1159958|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
1159887|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
1159888|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
1159930|NCT00412217|O1|Outcome|Erlotinib|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
1159963|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
1159889|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
1159890|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
1159891|NCT00412373|E2|Reported Event|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
1159892|NCT00412373|E1|Reported Event|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
1159893|NCT00412360|B3|Baseline|Total|Total of all reporting groups
1159894|NCT00412360|B2|Baseline|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
1159895|NCT00412360|B1|Baseline|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
1159896|NCT00412360|P2|Participant Flow|Double UCB Transplant|Double Cord Blood Unit Transplantation: Unrelated donor, double cord blood unit
1159897|NCT00412360|P1|Participant Flow|Single UCB Transplant|Single Cord Blood Unit Transplantation: Unrelated donor, single cord blood unit
1159898|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
1159899|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
1159900|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
1159901|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
1159902|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
1159903|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
1159904|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
1159905|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
1159906|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
1159907|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
1159908|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
1159909|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
1159910|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
1159911|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
1159912|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
1159913|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
1159914|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
1159915|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
1159916|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
1159917|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
1159918|NCT00412360|E2|Reported Event|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
1159919|NCT00412360|E1|Reported Event|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
1159920|NCT00412243|B1|Baseline|Clofarabine + Cyclophosphamide|"Clofarabine 40 mg/m^2 daily for 3 Days + Cyclophosphamide starting 200 mg/m^2 every 12 hours for 3 days~Clofarabine : 40 mg/m^2 Daily for 3 Days~Cyclophosphamide : Beginning dose 200 mg/m^2 every 12 hours for 3 days"
1159921|NCT00412243|P1|Participant Flow|Clofarabine + Cyclophosphamide|"Clofarabine 40 mg/m^2 daily for 3 Days + Cyclophosphamide starting 200 mg/m^2 every 12 hours for 3 days~Clofarabine : 40 mg/m^2 Daily for 3 Days~Cyclophosphamide : Beginning dose 200 mg/m^2 every 12 hours for 3 days"
1159922|NCT00412243|O1|Outcome|Clofarabine + Cyclophosphamide|"Clofarabine 40 mg/m^2 daily for 3 Days + Cyclophosphamide starting 200 mg/m^2 every 12 hours for 3 days~Clofarabine : 40 mg/m^2 Daily for 3 Days~Cyclophosphamide : Beginning dose 200 mg/m^2 every 12 hours for 3 days"
1159923|NCT00412243|E1|Reported Event|Clofarabine + Cyclophosphamide|"Clofarabine 40 mg/m^2 daily for 3 Days + Cyclophosphamide starting 200 mg/m^2 every 12 hours for 3 days~Clofarabine : 40 mg/m^2 Daily for 3 Days~Cyclophosphamide : Beginning dose 200 mg/m^2 every 12 hours for 3 days"
1159924|NCT00412217|B3|Baseline|Total|Total of all reporting groups
1159926|NCT00412217|B1|Baseline|Erlotinib|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
1159927|NCT00412217|P2|Participant Flow|Placebo|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
1159928|NCT00412217|P1|Participant Flow|Erlotinib|Participants with histologically confirmed advanced squamous cell carcinoma (SCC) of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 milligrams (mg) once daily for 1 year until disease progression or intolerable toxicity.
1159931|NCT00412217|O2|Outcome|Placebo|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
1159932|NCT00412217|O1|Outcome|Erlotinib|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
1159933|NCT00412217|O2|Outcome|Placebo|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
1159934|NCT00412217|O1|Outcome|Erlotinib|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
1159935|NCT00412217|O2|Outcome|Placebo|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
1159936|NCT00412217|O1|Outcome|Erlotinib|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
1159937|NCT00412217|E2|Reported Event|Placebo|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
1159938|NCT00412217|E1|Reported Event|Erlotinib|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
1159939|NCT00412113|B3|Baseline|Total|Total of all reporting groups
1159940|NCT00412113|B2|Baseline|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
1159941|NCT00412113|B1|Baseline|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
1159942|NCT00412113|P2|Participant Flow|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
1159943|NCT00412113|P1|Participant Flow|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
1159944|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
1159945|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
1159946|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
1159947|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
1159948|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
1159949|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
1159950|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
1159951|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
1159952|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
1159953|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
1159954|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
1159955|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
1159956|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
1159957|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
1159959|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
1159960|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
1159961|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
1159962|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
1159964|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
1159965|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
1159966|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
1159967|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
1159968|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
1159969|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
1159970|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
1159971|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
1159972|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
1159973|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
1159974|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
1159975|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
1159976|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
1159977|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
1159978|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
1159979|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
1159980|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
1159981|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
1159982|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
1159983|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
1159984|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
1159985|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
1159986|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
1159987|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
1159988|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
1159989|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
1159990|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
1159991|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
1159992|NCT00412113|E2|Reported Event|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
1159993|NCT00412113|E1|Reported Event|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
1159994|NCT00412087|B3|Baseline|Total|Total of all reporting groups
1160151|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
1159995|NCT00412087|B2|Baseline|Cholecalciferol 4000 IU|"Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
1160011|NCT00412074|P1|Participant Flow|Control 400 IU Vitamin D3|"400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad~vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given to her infant"
1160071|NCT00411749|O1|Outcome|V501|V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
1160072|NCT00411749|O2|Outcome|Placebo|Placebo vaccination 0.5 ml injection in 3 dosing regimen.
1159996|NCT00412087|B1|Baseline|Cholecalciferol 2000 IU|"Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery.~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
1159997|NCT00412087|P2|Participant Flow|Cholecalciferol 4000 IU|"Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
1159998|NCT00412087|P1|Participant Flow|Cholecalciferol 2000 IU|"Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery.~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
1159999|NCT00412087|O2|Outcome|Cholecalciferol 4000 IU|"Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
1160000|NCT00412087|O1|Outcome|Cholecalciferol 2000 IU|"Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery.~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
1160001|NCT00412087|O2|Outcome|Cholecalciferol 4000 IU|"Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
1160002|NCT00412087|O1|Outcome|Cholecalciferol 2000 IU|"Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery.~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
1160003|NCT00412087|E2|Reported Event|Cholecalciferol 4000 IU|"Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
1160004|NCT00412087|E1|Reported Event|Cholecalciferol 2000 IU|"Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery.~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
1160005|NCT00412074|B4|Baseline|Total|Total of all reporting groups
1160006|NCT00412074|B3|Baseline|6400 Vitamin D3 (Cholecalciferol)|"6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
1160007|NCT00412074|B2|Baseline|2400 Vitamin D3 (Cholecalciferol)|"2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
1160219|NCT00410826|B2|Baseline|Arm B (Cisplatin, Radiotherapy, Erlotinib)|Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO QD on days -7 to 47.
1160008|NCT00412074|B1|Baseline|Control 400 IU Vitamin D3|"400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad~vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given to her infant"
1160009|NCT00412074|P3|Participant Flow|6400 Vitamin D3 (Cholecalciferol)|"6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
1160010|NCT00412074|P2|Participant Flow|2400 IU Vitamin D3 (Cholecalciferol)|"2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
1160063|NCT00411749|P1|Participant Flow|V501|V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
1160012|NCT00412074|O3|Outcome|6400 IU Vitamin D3 (Cholecalciferol)|"6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~6400 IU Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant"
1160013|NCT00412074|O2|Outcome|2400 IU Vitamin D3 (Cholecalciferol)|"2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~2400 IU Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant"
1160014|NCT00412074|O1|Outcome|Control 400 IU Vitamin D3|"400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad~400 IU Vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given as oral supplement to her infant"
1160015|NCT00412074|O3|Outcome|6400 IU Vitamin D3 (Cholecalciferol)|"6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~6400 IU Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant"
1160016|NCT00412074|O2|Outcome|2400 IU Vitamin D3 (Cholecalciferol)|"2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~2400 IU Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant"
1160017|NCT00412074|O1|Outcome|Control 400 IU Vitamin D3|"400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad~400 IU Vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given as oral supplement to her infant"
1160018|NCT00412074|O3|Outcome|6400 Vitamin D3 (Cholecalciferol)|"6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
1160019|NCT00412074|O2|Outcome|2400 IU Vitamin D3 (Cholecalciferol)|"2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
1160020|NCT00412074|O1|Outcome|Control 400 IU Vitamin D3|"400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad~vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given to her infant"
1160021|NCT00412074|E3|Reported Event|6400 IU Vitamin D3 (Cholecalciferol)|"6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
1160022|NCT00412074|E2|Reported Event|2400 IU Vitamin D3 (Cholecalciferol)|"2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
1160023|NCT00412074|E1|Reported Event|Control 400 IU Vitamin D3|"400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad~vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given to her infant"
1160024|NCT00412061|B3|Baseline|Total|Total of all reporting groups
1160025|NCT00412061|B2|Baseline|Octreotide+ Placebo|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
1160026|NCT00412061|B1|Baseline|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
1160041|NCT00412061|O1|Outcome|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
1160709|NCT00410150|P2|Participant Flow|Control Group|Subjects randomized to the control arm of the study
1160027|NCT00412061|P2|Participant Flow|Octreotide+ Placebo Followed by Open Label Arm|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1. Open Label - Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.
1160028|NCT00412061|P1|Participant Flow|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
1160029|NCT00412061|O2|Outcome|Octreotide+ Placebo|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
1160064|NCT00411749|O4|Outcome|V501-HPV 18|HPV 18 serum antibody titer measured in V501 vaccination group
1160065|NCT00411749|O3|Outcome|V501-HPV 16|HPV 16 serum antibody titer measured in V501 vaccination group
1163387|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1160030|NCT00412061|O1|Outcome|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
1160031|NCT00412061|O1|Outcome|Everolimus Open Label Arm|Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.
1160032|NCT00412061|O2|Outcome|Octreotide+ Placebo|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
1160033|NCT00412061|O1|Outcome|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
1160034|NCT00412061|O2|Outcome|Octreotide+ Placebo Followed by Open Label Arm|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1. Open Label - Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.
1160035|NCT00412061|O1|Outcome|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
1160036|NCT00412061|O2|Outcome|Octreotide+ Placebo|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
1160037|NCT00412061|O1|Outcome|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
1160038|NCT00412061|O2|Outcome|Octreotide+ Placebo|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
1160039|NCT00412061|O1|Outcome|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
1160040|NCT00412061|O2|Outcome|Octreotide+ Placebo|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
1160042|NCT00412061|E3|Reported Event|Everolimus Open Label|Open Label - Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.
1160274|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
1160043|NCT00412061|E2|Reported Event|Placebo + Octreotide|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
1160044|NCT00412061|E1|Reported Event|Everolimus + Octreotide|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
1160066|NCT00411749|O2|Outcome|V501-HPV 11|HPV 11 serum antibody titer measured in V501 vaccination group
1160067|NCT00411749|O1|Outcome|V501-HPV 6|HPV 6 serum antibody titer measured in V501 vaccination group
1160068|NCT00411749|O2|Outcome|Placebo|Placebo vaccination 0.5 ml injection in 3 dosing regimen.
1160069|NCT00411749|O1|Outcome|V501|V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
1163388|NCT00402987|O3|Outcome|Placebo|
1160045|NCT00411788|B1|Baseline|Rapamycin and Trastuzumab|Patients received oral rapamycin/sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
1160046|NCT00411788|P1|Participant Flow|Rapamycin and Trastuzumab|Patients received oral rapamycin/sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
1160047|NCT00411788|O1|Outcome|Sirolimus and Trastuzumab|Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
1160048|NCT00411788|O1|Outcome|Sirolimus and Trastuzumab|Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
1160049|NCT00411788|O1|Outcome|Sirolimus and Trastuzumab|Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
1160050|NCT00411788|O1|Outcome|Sirolimus and Trastuzumab|Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
1160051|NCT00411788|O1|Outcome|Sirolimus and Trastuzumab|Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
1160052|NCT00411788|O1|Outcome|Sirolimus and Trastuzumab|Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
1160112|NCT00411619|P1|Participant Flow|Everolimus|This was a non-randomized, open-label, single arm study; all patients in the study received treatment with everolimus.
1160113|NCT00411619|O1|Outcome|Everolimus|This was a non-randomized, open-label, single arm study; all patients in the study received treatment with everolimus.
1160275|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
1160053|NCT00411788|E1|Reported Event|Sirolimus and Trastuzumab|Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
1160054|NCT00411762|B1|Baseline|PHY906 Administration|PHY906 800mg, orally, twice a day for days 1-4 and capecitabine 1500mg/m^2 days 1-7 of a 14-day cycle
1160055|NCT00411762|P1|Participant Flow|PHY906 Administration|"PHY906 800mg, orally, twice a day for days 1-4 and capecitabine 1500mg/m^2 days 1-7 of a 14-day cycle~Capecitabine~PHY906"
1160056|NCT00411762|O1|Outcome|PHY906 Administration|PHY906 800mg, twice a day for days 1-4 and capecitabine 1500mg/m^2 days 1-7 of a 14-day cycle
1160057|NCT00411762|O1|Outcome|PHY906 Administration|PHY906 800mg, twice a day for days 1-4 and capecitabine 1500mg/m^2 days 1-7 of a 14-day cycle
1160058|NCT00411762|E1|Reported Event|PHY906 Administration|PHY906 800mg, twice a day for days 1-4 and capecitabine 1500mg/m^2 days 1-7 of a 14-day cycle
1160059|NCT00411749|B3|Baseline|Total|Total of all reporting groups
1160060|NCT00411749|B2|Baseline|Placebo|Placebo vaccination 0.5 ml injection in 3 dosing regimen.
1160061|NCT00411749|B1|Baseline|V501|V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
1160062|NCT00411749|P2|Participant Flow|Placebo|Placebo vaccination 0.5 ml injection in 3 dosing regimen.
1160073|NCT00411749|O1|Outcome|V501|V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
1160074|NCT00411749|O2|Outcome|Placebo|Placebo vaccination 0.5 ml injection in 3 dosing regimen.
1160075|NCT00411749|O1|Outcome|V501|V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
1160076|NCT00411749|E2|Reported Event|Placebo|Placebo vaccination 0.5 ml injection in 3 dosing regimen.
1160077|NCT00411749|E1|Reported Event|V501|V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
1160078|NCT00411671|B1|Baseline|Sorafenib 400 mg|Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
1160079|NCT00411671|P1|Participant Flow|Sorafenib 400 mg|Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
1160080|NCT00411671|O1|Outcome|Sorafenib 400 mg|Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
1160081|NCT00411671|O1|Outcome|Sorafenib 400 mg|Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
1160082|NCT00411671|O1|Outcome|Sorafenib 400 mg|Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
1160083|NCT00411671|E1|Reported Event|Sorafenib 400 mg|Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
1160084|NCT00411645|B3|Baseline|Total|Total of all reporting groups
1160085|NCT00411645|B2|Baseline|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
1160086|NCT00411645|B1|Baseline|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
1160087|NCT00411645|P2|Participant Flow|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
1160088|NCT00411645|P1|Participant Flow|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
1160089|NCT00411645|O1|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
1160090|NCT00411645|O1|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
1160091|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
1160092|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
1160093|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
1160094|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
1160095|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
1160096|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
1160097|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
1160098|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
1160099|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
1160100|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
1160101|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
1160102|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
1160103|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
1160104|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
1160105|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
1160106|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
1160107|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
1160108|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
1160109|NCT00411645|E2|Reported Event|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
1160110|NCT00411645|E1|Reported Event|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
1160111|NCT00411619|B1|Baseline|Everolimus|This was a non-randomized, open-label, single arm study; all patients in the study received treatment with everolimus.
1163312|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1160114|NCT00411619|O1|Outcome|Everolimus|This was a non-randomized, open-label, single arm study; all patients in the study received treatment with everolimus. The initial starting dose was to be 3.0 mg/m2/day taken either daily or every other day with titration to achieve target trough concentrations of 5 to 15 ng/mL, subject to tolerability. Study drug was self-administered orally (or administered by a caregiver) at the same time each day.
1160115|NCT00411619|E1|Reported Event|Everolimus|This was a non-randomized, open-label, single arm study; all patients in the study received treatment with everolimus.
1160116|NCT00411554|B3|Baseline|Total|Total of all reporting groups
1160117|NCT00411554|B2|Baseline|Voglibose 0.2 mg TID|The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
1160118|NCT00411554|B1|Baseline|Sitagliptin 50 mg QD|The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
1160119|NCT00411554|P2|Participant Flow|Voglibose 0.2 mg TID|The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
1160120|NCT00411554|P1|Participant Flow|Sitagliptin 50 mg QD|The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
1160286|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
1160121|NCT00411554|O2|Outcome|Voglibose 0.2 mg TID|The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
1160122|NCT00411554|O1|Outcome|Sitagliptin 50 mg QD|The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
1160123|NCT00411554|O2|Outcome|Voglibose 0.2 mg TID|The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
1160124|NCT00411554|O1|Outcome|Sitagliptin 50 mg QD|The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
1160125|NCT00411554|O2|Outcome|Voglibose 0.2 mg TID|The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
1160126|NCT00411554|O1|Outcome|Sitagliptin 50 mg QD|The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
1160127|NCT00411554|E2|Reported Event|Voglibose 0.2 mg TID|The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
1160128|NCT00411554|E1|Reported Event|Sitagliptin 50 mg QD|The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
1160129|NCT00411463|B3|Baseline|Total|Total of all reporting groups
1160130|NCT00411463|B2|Baseline|Medication|"Subjects randomized to the medication arm will receive the FDA approved medication Seroquel (quetiapine)~Seroquel: Subjects will be started at 100 mg/day titrated to a maximum of 800 mg /day~Day 1-BID doses totaling 100 mg/day, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in BID divided doses, by Day 6 begin titration up to a maximum dose of 800 mg/day in increments no greater than 200 mg/day.~This titration schedule may be adjusted based on the subject's response and ability to tolerate Seroquel.~Subjects who are unable to tolerate the study medications, or for whom the study medications are an inappropriate clinical choice, will be treated openly by a clinic physician according to the standard of care guidelines designated by the American Psychiatric Association (2002) for the treatment of bipolar disorder. Subjects receiving standard of care treatment will continue to be seen and assessed per the protocol schedule."
1160131|NCT00411463|B1|Baseline|Psychotherapy|"Subjects randomized to the Psychotherapy arm will receive Interpersonal and Social Rhythm Therapy (IPSRT-BPII)~Interpersonal and Social Rhythm Therapy (IPSRT-BPII): IPSRT is comprised of three components: psychoeducation, social rhythm therapy, and standard IPT as developed for unipolar depression.~Psychoeducation focuses on a) the illness and its consequences, b) treatment options and associated side effects, and c) prodromal symptoms/detection of early warning symptoms."
1160132|NCT00411463|P2|Participant Flow|Medication|"Subjects randomized to the medication arm will receive the FDA approved medication Seroquel (quetiapine)~Seroquel: Subjects will be started at 100 mg/day titrated to a maximum of 800 mg /day~Day 1-BID doses totaling 100 mg/day, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in BID divided doses, by Day 6 begin titration up to a maximum dose of 800 mg/day in increments no greater than 200 mg/day.~This titration schedule may be adjusted based on the subject's response and ability to tolerate Seroquel.~Subjects who are unable to tolerate the study medications, or for whom the study medications are an inappropriate clinical choice, will be treated openly by a clinic physician according to the standard of care guidelines designated by the American Psychiatric Association (2002) for the treatment of bipolar disorder. Subjects receiving standard of care treatment will continue to be seen and assessed per the protocol schedule."
1160133|NCT00411463|P1|Participant Flow|Psychotherapy|"Subjects randomized to the Psychotherapy arm will receive Interpersonal and Social Rhythm Therapy (IPSRT-BPII)~Interpersonal and Social Rhythm Therapy (IPSRT-BPII): IPSRT is comprised of three components: psychoeducation, social rhythm therapy, and standard IPT as developed for unipolar depression.~Psychoeducation focuses on a) the illness and its consequences, b) treatment options and associated side effects, and c) prodromal symptoms/detection of early warning symptoms."
1160134|NCT00411463|O2|Outcome|Medication|"Subjects randomized to the medication arm will receive the FDA approved medication Seroquel (quetiapine)~Seroquel: Subjects will be started at 100 mg/day titrated to a maximum of 800 mg /day~Day 1-BID doses totaling 100 mg/day, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in BID divided doses, by Day 6 begin titration up to a maximum dose of 800 mg/day in increments no greater than 200 mg/day.~This titration schedule may be adjusted based on the subject's response and ability to tolerate Seroquel.~Subjects who are unable to tolerate the study medications, or for whom the study medications are an inappropriate clinical choice, will be treated openly by a clinic physician according to the standard of care guidelines designated by the American Psychiatric Association (2002) for the treatment of bipolar disorder. Subjects receiving standard of care treatment will continue to be seen and assessed per the protocol schedule."
1163313|NCT00402987|O4|Outcome|Placebo|
1160135|NCT00411463|O1|Outcome|Psychotherapy|"Subjects randomized to the Psychotherapy arm will receive Interpersonal and Social Rhythm Therapy (IPSRT-BPII)~Interpersonal and Social Rhythm Therapy (IPSRT-BPII): IPSRT is comprised of three components: psychoeducation, social rhythm therapy, and standard IPT as developed for unipolar depression.~Psychoeducation focuses on a) the illness and its consequences, b) treatment options and associated side effects, and c) prodromal symptoms/detection of early warning symptoms."
1160136|NCT00411463|O3|Outcome|Total|Total number of participants
1160137|NCT00411463|O2|Outcome|Medication|"Subjects randomized to the medication arm will receive the FDA approved medication Seroquel (quetiapine)~Seroquel: Subjects will be started at 100 mg/day titrated to a maximum of 800 mg /day~Day 1-BID doses totaling 100 mg/day, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in BID divided doses, by Day 6 begin titration up to a maximum dose of 800 mg/day in increments no greater than 200 mg/day.~This titration schedule may be adjusted based on the subject's response and ability to tolerate Seroquel.~Subjects who are unable to tolerate the study medications, or for whom the study medications are an inappropriate clinical choice, will be treated openly by a clinic physician according to the standard of care guidelines designated by the American Psychiatric Association (2002) for the treatment of bipolar disorder. Subjects receiving standard of care treatment will continue to be seen and assessed per the protocol schedule."
1160198|NCT00411151|O1|Outcome|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
1163389|NCT00402987|O2|Outcome|Celecoxib 100 mg (Pooled)|
1160138|NCT00411463|O1|Outcome|Psychotherapy|"Subjects randomized to the Psychotherapy arm will receive Interpersonal and Social Rhythm Therapy (IPSRT-BPII)~Interpersonal and Social Rhythm Therapy (IPSRT-BPII): IPSRT is comprised of three components: psychoeducation, social rhythm therapy, and standard IPT as developed for unipolar depression.~Psychoeducation focuses on a) the illness and its consequences, b) treatment options and associated side effects, and c) prodromal symptoms/detection of early warning symptoms."
1160139|NCT00411463|O2|Outcome|Medication|Patients taking Quetiapine (Seroquel) during 12 weeks of active treatment.
1160140|NCT00411463|O1|Outcome|Psychotherapy|Patients assigned to talk therapy (IPSRT) intervention during 12 weeks of active enrollment in study.
1160141|NCT00411463|O2|Outcome|Medication|"Subjects randomized to the medication arm will receive the FDA approved medication Seroquel (quetiapine)~Seroquel: Subjects will be started at 100 mg/day titrated to a maximum of 800 mg /day~Day 1-BID doses totaling 100 mg/day, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in BID divided doses, by Day 6 begin titration up to a maximum dose of 800 mg/day in increments no greater than 200 mg/day.~This titration schedule may be adjusted based on the subject's response and ability to tolerate Seroquel.~Subjects who are unable to tolerate the study medications, or for whom the study medications are an inappropriate clinical choice, will be treated openly by a clinic physician according to the standard of care guidelines designated by the American Psychiatric Association (2002) for the treatment of bipolar disorder. Subjects receiving standard of care treatment will continue to be seen and assessed per the protocol schedule."
1160142|NCT00411463|O1|Outcome|Psychotherapy|"Subjects randomized to the Psychotherapy arm will receive Interpersonal and Social Rhythm Therapy (IPSRT-BPII)~Interpersonal and Social Rhythm Therapy (IPSRT-BPII): IPSRT is comprised of three components: psychoeducation, social rhythm therapy, and standard IPT as developed for unipolar depression.~Psychoeducation focuses on a) the illness and its consequences, b) treatment options and associated side effects, and c) prodromal symptoms/detection of early warning symptoms."
1160143|NCT00411463|E2|Reported Event|Medication|"Subjects randomized to the medication arm will receive the FDA approved medication Seroquel (quetiapine)~Seroquel: Subjects will be started at 100 mg/day titrated to a maximum of 800 mg /day~Day 1-BID doses totaling 100 mg/day, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in BID divided doses, by Day 6 begin titration up to a maximum dose of 800 mg/day in increments no greater than 200 mg/day.~This titration schedule may be adjusted based on the subject's response and ability to tolerate Seroquel.~Subjects who are unable to tolerate the study medications, or for whom the study medications are an inappropriate clinical choice, will be treated openly by a clinic physician according to the standard of care guidelines designated by the American Psychiatric Association (2002) for the treatment of bipolar disorder. Subjects receiving standard of care treatment will continue to be seen and assessed per the protocol schedule."
1160144|NCT00411463|E1|Reported Event|Psychotherapy|"Subjects randomized to the Psychotherapy arm will receive Interpersonal and Social Rhythm Therapy (IPSRT-BPII)~Interpersonal and Social Rhythm Therapy (IPSRT-BPII): IPSRT is comprised of three components: psychoeducation, social rhythm therapy, and standard IPT as developed for unipolar depression.~Psychoeducation focuses on a) the illness and its consequences, b) treatment options and associated side effects, and c) prodromal symptoms/detection of early warning symptoms."
1160145|NCT00411450|B1|Baseline|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
1160146|NCT00411450|P1|Participant Flow|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
1160147|NCT00411450|O1|Outcome|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
1160148|NCT00411450|O1|Outcome|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
1160149|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
1160150|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
1163314|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
1160152|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
1160153|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
1160154|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
1160155|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
1160156|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
1160157|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
1160158|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
1160159|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
1160160|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
1160161|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
1160162|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
1160163|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
1160164|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
1160165|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
1160166|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
1160167|NCT00411450|O1|Outcome|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
1160168|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
1160169|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
1160170|NCT00411450|E1|Reported Event|Panitumumab + FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
1160171|NCT00411411|B3|Baseline|Total|Total of all reporting groups
1160172|NCT00411411|B2|Baseline|Januvia|Active treatment
1160173|NCT00411411|B1|Baseline|Placebo|Placebo treatment
1160174|NCT00411411|P2|Participant Flow|Januvia|Active treatment
1160175|NCT00411411|P1|Participant Flow|Placebo|Placebo treatment
1160176|NCT00411411|O2|Outcome|Januvia|"Active treatment~Januvia: 200 mg t.i.d"
1160177|NCT00411411|O1|Outcome|Placebo|"Placebo treatment, administered as tablets.~Placebo: Placebo"
1160178|NCT00411411|O2|Outcome|Januvia|"Active treatment~Januvia: 200 mg t.i.d"
1160179|NCT00411411|O1|Outcome|Placebo|Placebo: Placebo
1160180|NCT00411411|E2|Reported Event|Januvia|Active treatment. No adverse events recorded
1160181|NCT00411411|E1|Reported Event|Placebo|No adverse events recorded
1160182|NCT00411398|B1|Baseline|Memantine|Memantine tablets
1160183|NCT00411398|P1|Participant Flow|Memantine|Memantine tablets
1160184|NCT00411398|O1|Outcome|Memantine|Memantine tablets
1160185|NCT00411398|E1|Reported Event|Memantine|Memantine tablets
1160186|NCT00411216|B3|Baseline|Total|Total of all reporting groups
1160187|NCT00411216|B2|Baseline|Control Exercises|Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements
1160188|NCT00411216|B1|Baseline|Exercises for Gaze Stabilization|Experimental group performed gaze stabilization exercises: adaptation and substitution exercises encorporating retinal slip and head movements
1160189|NCT00411216|P2|Participant Flow|Control Exercises|"Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements~Control exercises: saccadic eye movements against a plain background; no head movements"
1160276|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
1160190|NCT00411216|P1|Participant Flow|Exercises for Gaze Stabilization|"Experimental group performed vestibular adaptation and substitution exercises~gaze stabilization exercises: adaptation and substitutin exercises encorporating retinal lsip and head movements"
1160191|NCT00411216|O2|Outcome|Control Exercises|"Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements~Control exercises: saccadic eye movements against a plain background; no head movements"
1160192|NCT00411216|O1|Outcome|Exercises for Gaze Stabilization|"Experimental group performed vestibular adaptation and substitution exercises~gaze stabilization exercises: adaptation and substitutin exercises encorporating retinal lsip and head movements"
1160193|NCT00411216|E2|Reported Event|Control Exercises|Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements
1160194|NCT00411216|E1|Reported Event|Exercises for Gaze Stabilization|Experimental group performed gaze stabilization exercises: adaptation and substitution exercises encorporating retinal slip and head movements
1160195|NCT00411151|B1|Baseline|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
1160196|NCT00411151|P1|Participant Flow|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
1160197|NCT00411151|O1|Outcome|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
1160199|NCT00411151|O1|Outcome|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
1160200|NCT00411151|O1|Outcome|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
1160201|NCT00411151|O1|Outcome|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
1160202|NCT00411151|O1|Outcome|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
1160203|NCT00411151|O1|Outcome|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
1160204|NCT00411151|E1|Reported Event|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
1160205|NCT00410904|B3|Baseline|Total|Total of all reporting groups
1160206|NCT00410904|B2|Baseline|Arm I Cohort B - Prior Bevacizumab (Avastin)|Patients receive AZD2171, 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 in 100 ml of 0.9% sodium chloride, IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
1160207|NCT00410904|B1|Baseline|Arm I Cohort A- No Prior Bevacizumab (Avastin)|Patients receive AZD2171, 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 in 100 ml of 0.9% sodium chloride, IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
1160208|NCT00410904|P2|Participant Flow|Arm I Cohort B- Prior Bevacizumab (Avastin)|Patients receive oral AZD2171 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
1160209|NCT00410904|P1|Participant Flow|Arm I Cohort A- No Prior Bevacizumab (Avastin)|Patients receive oral AZD2171 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
1160210|NCT00410904|O2|Outcome|Arm I - Cohort B, Prior Bevacizumab (Avastin)|Patients receive oral AZD2171 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
1160211|NCT00410904|O1|Outcome|Arm I - Cohort A, no Prior Bevacizumab (Avastin)|Patients receive oral AZD2171 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
1160212|NCT00410904|E2|Reported Event|Arm I - Cohort B|"This is a one arm study with two cohorts.~Cohort B: Prior bevacizumab before entering into this trial~Patients receive AZD2171, 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 in 100 ml of 0.9% sodium chloride, IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity."
1160213|NCT00410904|E1|Reported Event|Arm I - Cohort A|"This is a one arm study with two cohorts.~Cohort A: No prior bevacizumab before entering into this trial~Patients receive AZD2171, 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 in 100 ml of 0.9% sodium chloride, IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity."
1160214|NCT00410891|B1|Baseline|Topical Antibiotic|"topical gatifloxacin 4 times per day~gatifloxacin"
1160215|NCT00410891|P1|Participant Flow|Topical Antibiotic|"topical gatifloxacin 4 times per day~gatifloxacin"
1160216|NCT00410891|O1|Outcome|Topical Antibiotic|"topical gatifloxacin 4 times per day~gatifloxacin"
1160217|NCT00410891|E1|Reported Event|Topical Antibiotic|"topical gatifloxacin 4 times per day~gatifloxacin"
1160218|NCT00410826|B3|Baseline|Total|Total of all reporting groups
1160220|NCT00410826|B1|Baseline|Arm A (Cisplatin and Radiotherapy)|Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.
1160221|NCT00410826|P2|Participant Flow|Arm B (Cisplatin, Radiotherapy, Erlotinib)|Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO QD on days -7 to 47.
1160222|NCT00410826|P1|Participant Flow|Arm A (Cisplatin and Radiotherapy)|Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.
1160223|NCT00410826|O2|Outcome|Arm B (Cisplatin, Radiotherapy, Erlotinib)|Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO daily on days -7 to 47.
1160224|NCT00410826|O1|Outcome|Arm A (Cisplatin and Radiotherapy)|Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.
1160225|NCT00410826|O2|Outcome|Arm B (Cisplatin, Radiotherapy, Erlotinib)|Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO daily on days -7 to 47.
1160285|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
1163390|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1160226|NCT00410826|O1|Outcome|Arm A (Cisplatin and Radiotherapy)|Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.
1160227|NCT00410826|E2|Reported Event|Arm B (Cisplatin, Radiotherapy, Erlotinib)|Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO QD on days -7 to 47.
1160228|NCT00410826|E1|Reported Event|Arm A (Cisplatin and Radiotherapy)|Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.
1160229|NCT00410761|B3|Baseline|Total|Total of all reporting groups
1160230|NCT00410761|B2|Baseline|Placebo|Placebo daily
1160231|NCT00410761|B1|Baseline|Vandetanib 300 mg|Vandetanib (300 mg daily)
1160232|NCT00410761|P2|Participant Flow|Placebo|Placebo daily
1160233|NCT00410761|P1|Participant Flow|Vandetanib 300 mg|Vandetanib (300 mg daily)
1160234|NCT00410761|O2|Outcome|Placebo|Placebo daily
1160235|NCT00410761|O1|Outcome|Vandetanib 300 mg|Vandetanib (300 mg daily)
1160236|NCT00410761|O2|Outcome|Placebo|Placebo daily
1160237|NCT00410761|O1|Outcome|Vandetanib 300 mg|Vandetanib (300 mg daily)
1160238|NCT00410761|O2|Outcome|Placebo|Placebo daily
1160239|NCT00410761|O1|Outcome|Vandetanib 300 mg|Vandetanib (300 mg daily)
1160240|NCT00410761|O2|Outcome|Placebo|Placebo daily
1160241|NCT00410761|O1|Outcome|Vandetanib 300 mg|Vandetanib (300 mg daily)
1160242|NCT00410761|O2|Outcome|Placebo|Placebo daily
1160243|NCT00410761|O1|Outcome|Vandetanib 300 mg|Vandetanib (300 mg daily)
1160244|NCT00410761|O2|Outcome|Placebo|Placebo daily
1160245|NCT00410761|O1|Outcome|Vandetanib 300 mg|Vandetanib (300 mg daily)
1160246|NCT00410761|O2|Outcome|Placebo|Placebo daily
1160247|NCT00410761|O1|Outcome|Vandetanib 300 mg|Vandetanib (300 mg daily)
1160248|NCT00410761|O2|Outcome|Placebo|Placebo daily
1160249|NCT00410761|O1|Outcome|Vandetanib 300 mg|Vandetanib (300 mg daily)
1160250|NCT00410761|E2|Reported Event|Placebo|Placebo daily
1160251|NCT00410761|E1|Reported Event|Vandetanib 300 mg|Vandetanib (300 mg daily)
1160252|NCT00410514|B4|Baseline|Total|Total of all reporting groups
1160253|NCT00410514|B3|Baseline|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
1160254|NCT00410514|B2|Baseline|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
1160255|NCT00410514|B1|Baseline|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
1160256|NCT00410514|P3|Participant Flow|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
1160257|NCT00410514|P2|Participant Flow|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
1160258|NCT00410514|P1|Participant Flow|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
1160259|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
1160260|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
1160261|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
1160262|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
1160263|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
1160264|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
1160265|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
1160266|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
1160267|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
1160268|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
1160269|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
1160270|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
1160271|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
1160272|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
1160273|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
1163315|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
1160277|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
1160278|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
1160279|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
1160280|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
1160281|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
1160282|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
1160283|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
1160284|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
1160539|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
1160287|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
1160288|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
1160289|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
1160290|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
1160291|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
1160292|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
1160293|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
1160294|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
1160295|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
1160296|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
1160297|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
1160298|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
1160299|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
1160300|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
1160301|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
1160302|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
1160303|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
1160304|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
1160305|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
1160306|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
1160307|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
1160308|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
1160309|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
1160310|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
1160311|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
1160312|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
1160313|NCT00410514|E3|Reported Event|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
1160314|NCT00410514|E2|Reported Event|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
1160315|NCT00410514|E1|Reported Event|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
1160316|NCT00410488|B3|Baseline|Total|Total of all reporting groups
1160317|NCT00410488|B2|Baseline|Palonosetron - 3 Doses|"Arm 2: Palonosetron 0.25 mg IV for 3 doses (days 0, 2, 4).~Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
1160318|NCT00410488|B1|Baseline|Palonosetron - 1 Dose|"Arm 1: Palonosetron 0.25 mg intravenous (IV) for 1 dose (day 0).~Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
1160341|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
1160342|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
1160343|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
1160319|NCT00410488|P2|Participant Flow|Palonosetron - 3 Doses|"Arm 2: Palonosetron 0.25 mg IV for 3 doses (days 0, 2, 4).~Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
1160320|NCT00410488|P1|Participant Flow|Palonosetron - 1 Dose|"Arm 1: Palonosetron 0.25 mg intravenous (IV) for 1 dose (day 0).~Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
1160350|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
1160351|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
1160321|NCT00410488|O2|Outcome|Palonosetron - 3 Doses|"Arm 2: Palonosetron 0.25 mg IV for 3 doses (days 0, 2, 4).~Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
1160322|NCT00410488|O1|Outcome|Palonosetron - 1 Dose|"Arm 1: Palonosetron 0.25 mg intravenous (IV) for 1 dose (day 0).~Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
1160323|NCT00410488|E1|Reported Event|Palonosetron|"Arm 1: Palonosetron 0.25 mg intravenous (IV) for 1 dose (day 0) and Arm 2: Palonosetron 0.25 mg IV for 3 doses (days 0, 2, 4).~Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
1160324|NCT00410410|B7|Baseline|Total|Total of all reporting groups
1160325|NCT00410410|B6|Baseline|IP2C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
1160326|NCT00410410|B5|Baseline|IP Cohort 2 (IP2C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
1160327|NCT00410410|B4|Baseline|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1160328|NCT00410410|B3|Baseline|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
1160329|NCT00410410|B2|Baseline|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
1160330|NCT00410410|B1|Baseline|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
1160331|NCT00410410|P9|Participant Flow|ABA ~10 mg/kg, Open-Label Period (OL)|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
1160332|NCT00410410|P8|Participant Flow|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
1160333|NCT00410410|P7|Participant Flow|ABA ~10 mg/kg, Maintenance Period (MP)|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
1160334|NCT00410410|P6|Participant Flow|IP2C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
1160335|NCT00410410|P5|Participant Flow|IP Cohort 2 (IP2C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160336|NCT00410410|P4|Participant Flow|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1160337|NCT00410410|P3|Participant Flow|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
1160338|NCT00410410|P2|Participant Flow|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
1160339|NCT00410410|P1|Participant Flow|Induction Period Cohort 1 (IP1C)-Abatacept (ABA) 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160340|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
1163316|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1160344|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
1160345|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160346|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160347|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160348|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
1160349|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
1163391|NCT00402987|O4|Outcome|Placebo|
1160352|NCT00410410|O2|Outcome|ABA ~10 mg/kg, MP|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160353|NCT00410410|O1|Outcome|ABA 30/~10 mg/kg, MP|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
1160354|NCT00410410|O2|Outcome|ABA ~10 mg/kg, MP|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160355|NCT00410410|O1|Outcome|ABA 30/~10 mg/kg, MP|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
1160356|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
1160357|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
1160358|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
1160359|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
1160360|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
1160361|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
1160362|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
1160363|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
1160364|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
1160365|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
1160366|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
1160367|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
1160368|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
1160369|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
1160370|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
1160371|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
1160372|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
1160373|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
1160374|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
1160375|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
1160376|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
1160377|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
1160378|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
1160379|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
1160380|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
1160381|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
1160382|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
1160383|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
1160384|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
1160385|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
1160386|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
1163317|NCT00402987|O3|Outcome|Placebo|
1160387|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
1160388|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
1160389|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
1160390|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
1160391|NCT00410410|O2|Outcome|IP1C+IP2C: ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160392|NCT00410410|O1|Outcome|IP1C+IP2C: ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
1160460|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
1160393|NCT00410410|O2|Outcome|IP2C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160394|NCT00410410|O1|Outcome|IP2C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
1160395|NCT00410410|O2|Outcome|IP2C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160396|NCT00410410|O1|Outcome|IP2C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
1160397|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1160398|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg,|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
1160399|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160400|NCT00410410|O1|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
1160401|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1160402|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg,|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
1160403|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160404|NCT00410410|O1|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
1160405|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1160406|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg,|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
1160407|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160408|NCT00410410|O1|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
1160409|NCT00410410|O6|Outcome|IP2C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160410|NCT00410410|O5|Outcome|IP Cohort 2 (IP2C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160411|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1160412|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg,|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
1160413|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160414|NCT00410410|O1|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
1160415|NCT00410410|O6|Outcome|IP2C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160416|NCT00410410|O5|Outcome|IP Cohort 2 (IP2C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160417|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1160418|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg,|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
1160419|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160420|NCT00410410|O1|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
1160421|NCT00410410|O6|Outcome|IP2C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160422|NCT00410410|O5|Outcome|IP Cohort 2 (IP2C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160423|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1160424|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg,|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
1160425|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160426|NCT00410410|O1|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
1160427|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1160428|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
1160429|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
1160430|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160431|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
1160432|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
1160433|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1160434|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
1160435|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
1160436|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160437|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
1160438|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
1160439|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1160440|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
1160441|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
1160442|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160443|NCT00410410|O4|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
1160444|NCT00410410|O3|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160445|NCT00410410|O2|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
1160446|NCT00410410|O1|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1160447|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1160448|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
1160449|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
1160450|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160451|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1160452|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
1160528|NCT00410280|B2|Baseline|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
1160453|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
1160454|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160455|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1160456|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
1160457|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
1160458|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160459|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1160496|NCT00410384|B4|Baseline|Total|Total of all reporting groups
1160461|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
1160462|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160463|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1160464|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg,|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
1160465|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160466|NCT00410410|O1|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
1160467|NCT00410410|O4|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
1160468|NCT00410410|O3|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160469|NCT00410410|O2|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
1160470|NCT00410410|O1|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1160471|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1160472|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
1160473|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
1160474|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160475|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1160476|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
1160477|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
1160478|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160479|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1160480|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg,|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
1160481|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160482|NCT00410410|O1|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
1160483|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1160484|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
1160485|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
1160486|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160487|NCT00410410|E9|Reported Event|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
1160488|NCT00410410|E8|Reported Event|Placebo, IP1C|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1160489|NCT00410410|E7|Reported Event|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
1160490|NCT00410410|E6|Reported Event|ABA ~10mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
1160491|NCT00410410|E5|Reported Event|ABA ~10mg/kg,IP2C|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
1160492|NCT00410410|E4|Reported Event|ABA ~10 mg/kg,IP1C|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
1160493|NCT00410410|E3|Reported Event|ABA 3 mg/kg,IP1C|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
1160494|NCT00410410|E2|Reported Event|ABA 30/~10mg/kg,IP2C|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg.
1160495|NCT00410410|E1|Reported Event|ABA 30/~10 mg/kg,IP1C|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
1160497|NCT00410384|B3|Baseline|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
1160498|NCT00410384|B2|Baseline|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
1160499|NCT00410384|B1|Baseline|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
1160500|NCT00410384|P3|Participant Flow|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
1160501|NCT00410384|P2|Participant Flow|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
1160502|NCT00410384|P1|Participant Flow|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
1160503|NCT00410384|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
1160504|NCT00410384|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
1160505|NCT00410384|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
1160506|NCT00410384|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
1160507|NCT00410384|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
1160508|NCT00410384|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
1160509|NCT00410384|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
1160510|NCT00410384|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
1160511|NCT00410384|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
1160512|NCT00410384|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
1160513|NCT00410384|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
1160514|NCT00410384|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
1160515|NCT00410384|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
1160516|NCT00410384|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
1160517|NCT00410384|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
1160518|NCT00410384|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
1160519|NCT00410384|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
1160520|NCT00410384|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
1160521|NCT00410384|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
1160522|NCT00410384|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
1160523|NCT00410384|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
1160524|NCT00410384|E3|Reported Event|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
1160525|NCT00410384|E2|Reported Event|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
1160526|NCT00410384|E1|Reported Event|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
1160527|NCT00410280|B3|Baseline|Total|Total of all reporting groups
1160529|NCT00410280|B1|Baseline|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
1160530|NCT00410280|P2|Participant Flow|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
1160531|NCT00410280|P1|Participant Flow|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
1160532|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
1160533|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
1160534|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
1160535|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
1160536|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
1160537|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
1160538|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
1160540|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
1160541|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
1160542|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
1160543|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
1160544|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
1160545|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
1160546|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
1160547|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
1160548|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
1160549|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
1160550|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
1160551|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
1160552|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
1160553|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
1160554|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
1160555|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
1160556|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
1160557|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
1160558|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
1160559|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
1160560|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
1160561|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
1160562|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
1160563|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
1160564|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
1160565|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
1160566|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
1160567|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
1160568|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
1160569|NCT00410280|E2|Reported Event|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
1160570|NCT00410280|E1|Reported Event|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
1160571|NCT00410202|B4|Baseline|Total|Total of all reporting groups
1160572|NCT00410202|B3|Baseline|Adefovir + Lamivudine (ADV+LVD) Combination Therapy|ADV 10 mg + LVD 100 mg; Combination therapy given QD for 100 weeks
1160573|NCT00410202|B2|Baseline|Entecavir (ETV) Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
1160574|NCT00410202|B1|Baseline|Entecavir + Adefovir (ETV+ADV) Combination Therapy|ETV 1.0 mg + ADV 10 mg; Combination therapy given once daily (QD) for 100 weeks
1160575|NCT00410202|P3|Participant Flow|Adefovir + Lamivudine (ADV+LVD) Combination Therapy|ADV 10 mg + LVD 100 mg; Combination therapy given QD for 100 weeks
1160576|NCT00410202|P2|Participant Flow|Entecavir (ETV) Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
1160577|NCT00410202|P1|Participant Flow|Entecavir + Adefovir (ETV+ADV) Combination Therapy|ETV 1.0 mg + ADV 10 mg; Combination therapy given once daily (QD) for 100 weeks
1160578|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
1160579|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
1160580|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; QD for 100 weeks
1160581|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
1160626|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
1160710|NCT00410150|P1|Participant Flow|Heliox Group|Patients randomized to the Heliox arm of the study
1160582|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator’s discretion, and where permitted by the local health authorities and ethics committees.
1160583|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; QD for 100 weeks
1160584|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
1160585|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator’s discretion, and where permitted by the local health authorities and ethics committees.
1160586|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; QD for 100 weeks
1160587|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
1160588|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
1160589|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
1160590|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
1163392|NCT00402987|O3|Outcome|Celecoxib 100mg / 50mg|
1160591|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
1160592|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
1160593|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
1160594|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator’s discretion, and where permitted by the local health authorities and ethics committees.
1160595|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
1160596|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
1160597|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator’s discretion, and where permitted by the local health authorities and ethics committees.
1160598|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
1160599|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
1160600|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
1160601|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
1160602|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
1160603|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator’s discretion, and where permitted by the local health authorities and ethics committees.
1160604|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
1160605|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
1160606|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
1160607|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
1160608|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
1160609|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
1160610|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
1160611|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
1160612|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
1160613|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
1160614|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
1160615|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
1160616|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
1160617|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
1160618|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
1160619|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
1160620|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
1160621|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator’s discretion, and where permitted by the local health authorities and ethics committees.
1160622|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
1160623|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
1160624|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
1160625|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
1160627|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
1160628|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
1160629|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
1160630|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
1160631|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
1160632|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
1160633|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
1160634|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
1160635|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
1160636|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
1160637|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
1160638|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
1160639|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
1160640|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
1160641|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
1160642|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
1160643|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
1160644|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
1160645|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
1160646|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
1160647|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
1160648|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
1160649|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
1160650|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
1160651|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
1160652|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
1160653|NCT00410202|E3|Reported Event|ETV + ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
1160654|NCT00410202|E2|Reported Event|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
1160655|NCT00410202|E1|Reported Event|ADV + LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
1160656|NCT00410189|B1|Baseline|ZD6474|ZD6474 300 mg by mouth daily.
1160657|NCT00410189|P1|Participant Flow|ZD6474|ZD6474 300 mg by mouth daily.
1160658|NCT00410189|O1|Outcome|ZD6474|ZD6474 300 mg by mouth daily.
1160659|NCT00410189|O1|Outcome|ZD6474|ZD6474 300 mg by mouth daily.
1160660|NCT00410189|E1|Reported Event|ZD6474|ZD6474 300 mg by mouth daily.
1160661|NCT00410163|B3|Baseline|Total|Total of all reporting groups
1160662|NCT00410163|B2|Baseline|Ofatumumab 1000 mg + FC|Ofatumumab iv infusion initiated at 300 mg for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/m^2 daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160663|NCT00410163|B1|Baseline|Ofatumumab 500 mg + FC|Ofatumumab iv infusion initiated at 300 mg for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/m^2 daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160664|NCT00410163|P2|Participant Flow|Ofatumumab 1000 mg + FC|Ofatumumab iv infusion initiated at 300 mg for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/m^2 daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses. After the last infusion, the disease status of the participants was evaluated every 3 months up to 18 months during the Follow-up Period. Participants were monitored in the Extended Follow-up Phase every 6 months for survival until alternative CLL therapy was initiated, or until Month 60.
1160665|NCT00410163|P1|Participant Flow|Ofatumumab 500 mg + Fludarabine and Cyclophosphamide (FC)|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses. After the last infusion, the disease status of the participants was evaluated every 3 months up to 18 months during the Follow-up Period. Participants were monitored in the Extended Follow-up Phase every 6 months for survival until alternative Chronic Lymphocyte Leukemia (CLL) therapy was initiated, or until Month 60.
1160706|NCT00410150|B3|Baseline|Total|Total of all reporting groups
1160666|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160667|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160668|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160669|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160890|NCT00409773|B3|Baseline|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
1160670|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160671|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160672|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160673|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160674|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160675|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160676|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160677|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160678|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160679|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160680|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160681|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160682|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160683|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160684|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160707|NCT00410150|B2|Baseline|Control Group|Subjects randomized to the control arm of the study
1160708|NCT00410150|B1|Baseline|Heliox Group|Patients randomized to the Heliox arm of the study
1163318|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
1160685|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160686|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160687|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160688|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160689|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160690|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160691|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160692|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160693|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160694|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160695|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160696|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160697|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160698|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160699|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160700|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab iv infusion initiated at 300 mg for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/m^2 daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160701|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab iv infusion initiated at 300 mg for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/m^2 daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160702|NCT00410163|E4|Reported Event|Ofatumumab 1000 mg + FC: Extended Follow-up Phase|Participants were monitored in the Extended Follow-up Phase every 6 months for survival until alternative CLL therapy was initiated, or until Month 60.
1160703|NCT00410163|E3|Reported Event|Ofatumumab 500 mg + FC: Extended Follow-up Phase|Participants were monitored in the Extended Follow-up Phase every 6 months for survival until alternative Chronic Lymphocyte Leukemia (CLL) therapy was initiated, or until Month 60.
1160704|NCT00410163|E2|Reported Event|Ofatumumab 1000 mg + FC|Ofatumumab iv infusion initiated at 300 mg for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/m^2 daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160705|NCT00410163|E1|Reported Event|Ofatumumab 500 mg + Fludarabine and Cyclophosphamide (FC)|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
1160711|NCT00410150|O2|Outcome|Control Group|Subjects randomized to the control arm of the study
1160712|NCT00410150|O1|Outcome|Heliox Group|Patients randomized to the Heliox arm of the study
1160713|NCT00410150|E2|Reported Event|Control Group|Subjects randomized to the control arm of the study
1160714|NCT00410150|E1|Reported Event|Heliox Group|Patients randomized to the Heliox arm of the study
1160715|NCT00410124|B3|Baseline|Total|Total of all reporting groups
1160716|NCT00410124|B2|Baseline|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
1160756|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
1160757|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
1160717|NCT00410124|B1|Baseline|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
1160718|NCT00410124|P2|Participant Flow|Placebo + BSC / RAD001|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
1160719|NCT00410124|P1|Participant Flow|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
1160720|NCT00410124|O1|Outcome|Day 15|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 15 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed.
1160721|NCT00410124|O1|Outcome|Day 15|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 15 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed.
1160722|NCT00410124|O2|Outcome|Day 15|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 15 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed.
1160723|NCT00410124|O1|Outcome|Day 1|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 1 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed. Troughs were collected for all patients on Day 1 of each treatment Cycle from month 2 until discontinuation from the study drug.
1160724|NCT00410124|O2|Outcome|Day 15|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 15 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed.
1160725|NCT00410124|O1|Outcome|Day 1|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 1 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed. Troughs were collected for all patients on Day 1 of each treatment Cycle from month 2 until discontinuation from the study drug.
1160726|NCT00410124|O2|Outcome|Day 15|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 15 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed.
1160727|NCT00410124|O1|Outcome|Day 1|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 1 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed. Troughs were collected for all patients on Day 1 of each treatment Cycle from month 2 until discontinuation from the study drug.
1160728|NCT00410124|O2|Outcome|Day 15|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 15 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed.
1160729|NCT00410124|O1|Outcome|Day 1|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 1 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed. Troughs were collected for all patients on Day 1 of each treatment Cycle from month 2 until discontinuation from the study drug.
1160730|NCT00410124|O2|Outcome|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
1160731|NCT00410124|O1|Outcome|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
1160732|NCT00410124|O2|Outcome|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
1160794|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
1160941|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
1160733|NCT00410124|O1|Outcome|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
1160734|NCT00410124|O2|Outcome|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
1160758|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
1160759|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
1160760|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
1160761|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
1160735|NCT00410124|O1|Outcome|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
1160736|NCT00410124|O2|Outcome|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
1160737|NCT00410124|O1|Outcome|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
1160738|NCT00410124|O2|Outcome|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
1160739|NCT00410124|O1|Outcome|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
1160740|NCT00410124|O2|Outcome|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
1160741|NCT00410124|O1|Outcome|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
1160742|NCT00410124|O2|Outcome|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
1160743|NCT00410124|O1|Outcome|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
1160744|NCT00410124|E3|Reported Event|Randomized to Placebo + BSC (Double Blind Only)|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care.
1160745|NCT00410124|E2|Reported Event|Randomized to Placebo + BSC (Open Label)|With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
1160795|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
1160746|NCT00410124|E1|Reported Event|Randomized to RAD001+ BSC ( Blinded + Open Label)|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
1160747|NCT00410072|B3|Baseline|Total|Total of all reporting groups
1160748|NCT00410072|B2|Baseline|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
1160749|NCT00410072|B1|Baseline|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
1160750|NCT00410072|P2|Participant Flow|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
1160751|NCT00410072|P1|Participant Flow|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
1160752|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
1160753|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
1160754|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
1160755|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
1160762|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
1160763|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
1160764|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
1160765|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
1160766|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
1160767|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
1160768|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
1160769|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
1160770|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
1160771|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
1160772|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
1160773|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
1160774|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
1160775|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
1160776|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
1160777|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
1160778|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
1160779|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
1160780|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
1160781|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
1160782|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
1160783|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
1160784|NCT00410072|E2|Reported Event|ETV/TDF 0.5 mg +TDF 300 mg|ETV 0.5 mg plus TDF 300 mg combination therapy given once daily (QD) for 100 weeks
1160785|NCT00410072|E1|Reported Event|ETV 0.5 mg|ETV 0.5 mg monotherapy given QD for 100 weeks
1160786|NCT00410046|B1|Baseline|Etanercept|Patients received ETN dose 50 mg once weekly or Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into this study, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
1160787|NCT00410046|P1|Participant Flow|Etanercept|Patients received ETN dose 50 mg once weekly or Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into this study, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
1160788|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
1160789|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
1160790|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
1160791|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
1160792|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
1160793|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
1160936|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
1160796|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
1160797|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
1160798|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
1160799|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
1160800|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
1160801|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
1163393|NCT00402987|O2|Outcome|Celecoxib 100 mg / Placebo|
1160802|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
1160803|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
1160804|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
1160805|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
1160806|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
1160807|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
1160808|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
1160809|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
1160810|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
1160811|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
1160812|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
1160813|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
1160814|NCT00410046|E1|Reported Event|Etanercept|Patients received ETN dose 50 mg once weekly or Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into this study, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
1160815|NCT00409838|B3|Baseline|Total|Total of all reporting groups
1160816|NCT00409838|B2|Baseline|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
1160817|NCT00409838|B1|Baseline|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
1160818|NCT00409838|P2|Participant Flow|Placebo|Placebo was administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141 (6-month treatment).
1160819|NCT00409838|P1|Participant Flow|Abatacept, 10 mg/kg|"Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141 (6-month treatment).~Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg."
1160820|NCT00409838|O2|Outcome|Placebo|Short-term Period. Participants received placebo IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
1160821|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
1160822|NCT00409838|O2|Outcome|Placebo|Short-term Period. Participants received placebo IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
1160937|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
1160938|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
1160823|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
1160824|NCT00409838|O2|Outcome|Placebo|Short-term Period: Participants received placebo administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
1160825|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
1160826|NCT00409838|O2|Outcome|Placebo|Short-term Period: Participants received placebo IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
1160863|NCT00409838|O2|Outcome|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
1160827|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
1160828|NCT00409838|O2|Outcome|Placebo|Short-term Period: Participants received placebo IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
1160829|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
1160830|NCT00409838|O2|Outcome|Placebo|Short-term Period: Placebo was administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
1160831|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
1160832|NCT00409838|O2|Outcome|Placebo|Short-term Period: Placebo was administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
1160833|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
1160834|NCT00409838|O2|Outcome|Placebo|Short-term Period: Placebo was administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
1160835|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
1160836|NCT00409838|O2|Outcome|Placebo|Short-term Period: Placebo administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. LTE Period: Abatacept, administered IV monthly at a fixed dose of approximately 10 mg/kg for an average of approximately 41 months on a background of methotrexate.
1160837|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Abatacept administered IV in a body-weight tiered dose approximating 10 mg/kg. Study medication was administered on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141. LTE Period: Abatacept, administered IV monthly at a fixed dose of approximately 10 mg/kg for an average of approximately 41 months on a background of methotrexate.
1160838|NCT00409838|O1|Outcome|All Treated|Abatacept was administered intravenously monthly at a fixed dose of approximately 10 mg/kg in the LTE period on a background of methotrexate
1160839|NCT00409838|O1|Outcome|All Treated|Abatacept, administered intravenously IV monthly at a fixed dose of approximately 10 mg/kg for an average of approximately 41 months in the LTE period on a background of methotrexate
1160840|NCT00409838|O2|Outcome|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
1160841|NCT00409838|O1|Outcome|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
1160842|NCT00409838|O2|Outcome|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
1160939|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
1160843|NCT00409838|O1|Outcome|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
1160844|NCT00409838|O1|Outcome|Abatacept + Background Methotrexate|Dosage: 500 mg to 1 g; subjects randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
1160845|NCT00409838|O3|Outcome|Abatacept 500 mg and 750 mg|
1160846|NCT00409838|O2|Outcome|Abatacept 750 mg|
1160847|NCT00409838|O1|Outcome|Abatacept 500 mg|
1160848|NCT00409838|O3|Outcome|Abatacept 500 mg and 750 mg|
1160849|NCT00409838|O2|Outcome|Abatacept 750 mg|
1160850|NCT00409838|O1|Outcome|Abatacept 500 mg|
1160851|NCT00409838|O3|Outcome|Abatacept 500 mg and 750 mg|
1160852|NCT00409838|O2|Outcome|Abatacept 750 mg|
1160853|NCT00409838|O1|Outcome|Abatacept 500 mg|
1160854|NCT00409838|O3|Outcome|Abatacept 500 mg and 750 mg|
1160855|NCT00409838|O2|Outcome|Abatacept 750 mg|
1160856|NCT00409838|O1|Outcome|Abatacept 500 mg|
1160857|NCT00409838|O3|Outcome|Abatacept 500 mg and 750 mg|
1160858|NCT00409838|O2|Outcome|Abatacept 750 mg|
1160859|NCT00409838|O1|Outcome|Abatacept 500 mg|
1160860|NCT00409838|O3|Outcome|Abatacept 500 mg and 750 mg|
1160861|NCT00409838|O2|Outcome|Abatacept 750 mg|
1160862|NCT00409838|O1|Outcome|Abatacept 500 mg|
1160864|NCT00409838|O1|Outcome|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
1160865|NCT00409838|O2|Outcome|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
1160866|NCT00409838|O1|Outcome|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
1160867|NCT00409838|O2|Outcome|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
1160868|NCT00409838|O1|Outcome|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
1160869|NCT00409838|O2|Outcome|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
1160870|NCT00409838|O1|Outcome|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
1160871|NCT00409838|O2|Outcome|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
1160872|NCT00409838|O1|Outcome|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
1160873|NCT00409838|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141.
1160874|NCT00409838|O1|Outcome|Abatacept|Participants received abatacept in a body-weight tiered dose approximating 10 mg/kg administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141.
1160875|NCT00409838|O2|Outcome|Placebo|Participants received placebo IV on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141.
1160876|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Participants received abatacept in a body-weight tiered dose approximating 10 mg/kg intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141.
1160877|NCT00409838|E2|Reported Event|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
1160878|NCT00409838|E1|Reported Event|Abatacept 10 mg/kg|500 mg to 1 g; subjects randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
1160879|NCT00409825|B1|Baseline|AUC1 vs AUC2|"AUC 1 done after 4 weekly 17-OHPC injections completed, between 20 6/7 to 24 6/7 weeks gestation. 10 cc blood drawn pre-5th injection. 10 cc blood drawn 12 hours post-dose and 7 consecutive days. 24-hour urine collected days 4-5 within 7 days post-injection.~AUC 2 done 31 0/7 to 34 6/7 or at 35 0/7 weeks. 10 cc blood drawn pre weekly injection, 12 hours post-dose, and 7 consecutive days. 24-hour urine collected between days 4-5 within 7 days post-injection."
1160880|NCT00409825|P1|Participant Flow|AUC1 vs AUC2|"AUC 1 done after 4 weekly 17-OHPC injections completed, between 20 6/7 to 24 6/7 weeks gestation. 10 cc blood drawn pre-5th injection. 10 cc blood drawn 12 hours post-dose and 7 consecutive days. 24-hour urine collected days 4-5 within 7 days post-injection.~AUC 2 done 31 0/7 to 34 6/7 or at 35 0/7 weeks. 10 cc blood drawn pre weekly injection, 12 hours post-dose, and 7 consecutive days. 24-hour urine collected between days 4-5 within 7 days post-injection."
1160881|NCT00409825|O1|Outcome|Part 1|Part 1 done after 4 weekly 17-OHPC injections completed, between 20 6/7 to 24 6/7 weeks gestation. 10 cc blood drawn pre-5th injection. 10 cc blood drawn 12 hours post-dose and 7 consecutive days. 24-hour urine collected days 4-5 within 7 days post-injection. Part 2 done 31 0/7 to 34 6/7 or at 35 0/7 weeks. 10 cc blood drawn pre weekly injection, 12 hours post-dose, and 7 consecutive days. 24-hour urine collected between days 4-5 within 7 days post-injection.
1160940|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
1160882|NCT00409825|E1|Reported Event|Part 1|Part 1 done after 4 weekly 17-OHPC injections completed, between 20 6/7 to 24 6/7 weeks gestation. 10 cc blood drawn pre-5th injection. 10 cc blood drawn 12 hours post-dose and 7 consecutive days. 24-hour urine collected days 4-5 within 7 days post-injection. Part 2 done 31 0/7 to 34 6/7 or at 35 0/7 weeks. 10 cc blood drawn pre weekly injection, 12 hours post-dose, and 7 consecutive days. 24-hour urine collected between days 4-5 within 7 days post-injection. A subject in whom Part 2 is performed during the last scheduled injection of 17-OHPC (at or around 35 0/7 weeks) will have the option to participate in Part 4, in which 10 cc of blood will be drawn serially over 21 days after completing Part 2. Blood will be drawn on days 9, 11, 14, 17, 20, 24, 28 after the last injection. Part 3: At the time of labor and delivery, subject will have 10cc of blood removed from a maternal peripheral vein. 10cc of blood will be collected from the placenta/umbilical cord after delivery.
1160883|NCT00409786|B1|Baseline|VLM Online Lifestyle Counseling|Overweight primary care patient participants receiving the Virtual Lifestyle Management (VLM) Program online lifestyle counseling intervention.
1160884|NCT00409786|P1|Participant Flow|VLM Online Lifestyle Counseling|Overweight primary care patient participants receiving the Virtual Lifestyle Management (VLM) Program online lifestyle counseling intervention.
1160885|NCT00409786|O1|Outcome|Group 1|All participants
1160886|NCT00409786|E1|Reported Event|VLM Online Lifestyle Counseling|Overweight primary care patient participants receiving the Virtual Lifestyle Management (VLM) Program online lifestyle counseling intervention.
1160887|NCT00409773|B6|Baseline|Total|Total of all reporting groups
1160888|NCT00409773|B5|Baseline|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
1160889|NCT00409773|B4|Baseline|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
1163394|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1160891|NCT00409773|B2|Baseline|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
1160892|NCT00409773|B1|Baseline|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
1160893|NCT00409773|P5|Participant Flow|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
1160894|NCT00409773|P4|Participant Flow|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
1160895|NCT00409773|P3|Participant Flow|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
1160896|NCT00409773|P2|Participant Flow|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
1160897|NCT00409773|P1|Participant Flow|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
1160898|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
1160899|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
1160900|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
1160901|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
1160902|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
1160903|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
1160904|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
1160905|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
1160906|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
1160907|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
1160908|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
1160909|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
1160910|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
1160911|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
1160912|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
1160913|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
1160914|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
1160915|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
1160916|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
1160917|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
1160918|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
1160919|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
1160920|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
1160921|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
1160922|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
1160923|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
1160924|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
1160925|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
1160926|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
1160927|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
1160928|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
1160929|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
1160930|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
1160931|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
1160932|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
1160933|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
1160934|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
1160935|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
1160942|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
1160943|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
1160944|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
1160945|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
1160946|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
1160947|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
1160948|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
1160949|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
1160950|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
1160951|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
1160952|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
1160953|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
1160954|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
1160955|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
1160956|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
1160957|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
1160958|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
1160959|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
1160960|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
1160961|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
1160962|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
1160963|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
1160964|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
1160965|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
1160966|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
1160967|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
1160968|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
1160969|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
1160970|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
1160971|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
1160972|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
1160973|NCT00409773|E5|Reported Event|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
1160974|NCT00409773|E4|Reported Event|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
1160975|NCT00409773|E3|Reported Event|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
1160976|NCT00409773|E2|Reported Event|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
1160977|NCT00409773|E1|Reported Event|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
1160978|NCT00409747|B1|Baseline|Minocycline|Open-label minocycline treatment at 1.4 mg/kg/day
1160979|NCT00409747|P1|Participant Flow|Minocycline|Open-label minocycline treatment at 1.4 mg/kg/day
1160980|NCT00409747|O1|Outcome|Minocycline|Open-label minocycline treatment at 1.4 mg/kg/day
1160981|NCT00409747|O1|Outcome|Minocycline|Open-label minocycline treatment at 1.4 mg/kg/day
1160982|NCT00409747|E1|Reported Event|Overall Study/Minocycline|
1160983|NCT00409708|B3|Baseline|Total|Total of all reporting groups
1160984|NCT00409708|B2|Baseline|Behavior Therapy|0 mg/day Ritalin LA
1160985|NCT00409708|B1|Baseline|Ritalin LA Plus Behavior Therapy|10-60 mg/day
1160986|NCT00409708|P2|Participant Flow|Behavior Therapy|0 mg/day Ritalin LA
1160987|NCT00409708|P1|Participant Flow|Ritalin LA Plus Behavior Therapy|10-60 mg/day
1160988|NCT00409708|O2|Outcome|Behavior Therapy|0 mg/day Ritalin LA
1160989|NCT00409708|O1|Outcome|Ritalin LA Plus Behavior Therapy|10-60 mg/day
1160990|NCT00409708|O2|Outcome|Behavior Therapy|0 mg/day Ritalin LA
1160991|NCT00409708|O1|Outcome|Ritalin LA Plus Behavior Therapy|10-60 mg/day
1160992|NCT00409708|O2|Outcome|Behavior Therapy|0 mg/day Ritalin LA
1160993|NCT00409708|O1|Outcome|Ritalin LA Plus Behavior Therapy|10-60 mg/day
1160994|NCT00409708|O2|Outcome|Behavior Therapy|0 mg/day Ritalin LA
1160995|NCT00409708|O1|Outcome|Ritalin LA Plus Behavior Therapy|10-60 mg/day
1160996|NCT00409708|O2|Outcome|Behavior Therapy|0 mg/day Ritalin LA
1160997|NCT00409708|O1|Outcome|Ritalin LA Plus Behavior Therapy|10-60 mg/day
1160998|NCT00409708|O2|Outcome|Behavior Therapy|0 mg/day Ritalin LA
1160999|NCT00409708|O1|Outcome|Ritalin LA Plus Behavior Therapy|10-60 mg/day
1161000|NCT00409708|O2|Outcome|Behavior Therapy|0 mg/day Ritalin LA
1161001|NCT00409708|O1|Outcome|Ritalin LA Plus Behavior Therapy|10-60 mg/day
1161002|NCT00409708|E2|Reported Event|Behavior|Behavior
1161003|NCT00409708|E1|Reported Event|Ritalin+Behavior|Ritalin+Behavior
1161004|NCT00409682|B4|Baseline|Total|Total of all reporting groups
1161041|NCT00409578|B2|Baseline|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
1161042|NCT00409578|B1|Baseline|Placebo|Placebo tablets and capsules
1161237|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
1162071|NCT00406653|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
1161005|NCT00409682|B3|Baseline|Low-Dose Adalimumab: 20 mg or 10 mg (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
1161006|NCT00409682|B2|Baseline|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
1161007|NCT00409682|B1|Baseline|Open-label Adalimumab (Week 0 to Week 4)|All subjects received an open-label adalimumab induction regimen. Subjects weighing greater than or equal to 40 kg at Baseline received 160 mg at Week 0 and 80 mg at Week 2. Subjects weighing less than 40 kg at Baseline received 80 mg at Week 0 and 40mg at Week 2.
1161049|NCT00409578|O2|Outcome|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
1161008|NCT00409682|P3|Participant Flow|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] ≥ 40 kg) or 20 mg adalimumab eow (if Week 4 BW < 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
1161009|NCT00409682|P2|Participant Flow|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] ≥ 40 kg) or 10 mg adalimumab eow (if Week 4 BW < 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
1161010|NCT00409682|P1|Participant Flow|Open-label Adalimumab (Week 0 to Week 4)|All subjects received an open-label adalimumab induction regimen. Subjects weighing ≥ 40 kg at Baseline received 160 mg at Week 0 and 80 mg at Week 2. Subjects weighing < 40 kg at Baseline received 80 mg at Week 0 and 40 mg at Week 2.
1161011|NCT00409682|O2|Outcome|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
1161012|NCT00409682|O1|Outcome|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
1161013|NCT00409682|O2|Outcome|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
1161014|NCT00409682|O1|Outcome|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
1161015|NCT00409682|O2|Outcome|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
1161096|NCT00409539|E5|Reported Event|120mg Dose of SMP-986|"120mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
1161016|NCT00409682|O1|Outcome|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
1161017|NCT00409682|O2|Outcome|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
1161018|NCT00409682|O1|Outcome|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
1161050|NCT00409578|O1|Outcome|Placebo|Placebo tablets and capsules
1161117|NCT00409344|O2|Outcome|Dexmedetomidine|This group will receive dexmedetomidine
1161019|NCT00409682|O2|Outcome|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
1161020|NCT00409682|O1|Outcome|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
1161021|NCT00409682|O2|Outcome|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
1161022|NCT00409682|O1|Outcome|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
1161023|NCT00409682|E3|Reported Event|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|
1161024|NCT00409682|E2|Reported Event|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|
1161025|NCT00409682|E1|Reported Event|Open-label Adalimumab (Week 0 to Week 4)|
1161026|NCT00409617|B1|Baseline|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
1161027|NCT00409617|P1|Participant Flow|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
1161028|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
1163319|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1161029|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
1161030|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
1161031|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
1161074|NCT00409565|E1|Reported Event|Cetuximab Plus Bevacizumab|"Cetuximab plus bevacizumab~Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY~• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations~Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given"
1161032|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
1161033|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
1161034|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
1161035|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
1161036|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
1161037|NCT00409617|E1|Reported Event|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
1161038|NCT00409578|B5|Baseline|Total|Total of all reporting groups
1161039|NCT00409578|B4|Baseline|Aliskiren/Valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
1161040|NCT00409578|B3|Baseline|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
1161234|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
1161043|NCT00409578|P4|Participant Flow|Aliskiren/Valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
1161044|NCT00409578|P3|Participant Flow|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
1161045|NCT00409578|P2|Participant Flow|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
1161046|NCT00409578|P1|Participant Flow|Placebo|Placebo tablets and capsules
1161047|NCT00409578|O4|Outcome|Aliskiren/Valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
1161048|NCT00409578|O3|Outcome|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
1161075|NCT00409539|B6|Baseline|Total|Total of all reporting groups
1161118|NCT00409344|O1|Outcome|Saline|This group will recive saline
1163395|NCT00402987|O3|Outcome|Placebo|
1161051|NCT00409578|O4|Outcome|Aliskiren/Valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
1161052|NCT00409578|O3|Outcome|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
1161053|NCT00409578|O2|Outcome|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
1161054|NCT00409578|O1|Outcome|Placebo|Placebo tablets and capsules
1161055|NCT00409578|O4|Outcome|Aliskiren/Valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
1161056|NCT00409578|O3|Outcome|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
1161057|NCT00409578|O2|Outcome|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
1161058|NCT00409578|O1|Outcome|Placebo|Placebo tablets and capsules
1161059|NCT00409578|O4|Outcome|Aliskiren/Valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
1161060|NCT00409578|O3|Outcome|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
1161061|NCT00409578|O2|Outcome|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
1161062|NCT00409578|O1|Outcome|Placebo|Placebo tablets and capsules
1161063|NCT00409578|E4|Reported Event|Aliskiren/Valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
1161064|NCT00409578|E3|Reported Event|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
1161065|NCT00409578|E2|Reported Event|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
1161066|NCT00409578|E1|Reported Event|Placebo|Placebo tablets and capsules
1161067|NCT00409565|B1|Baseline|Cetuximab Plus Bevacizumab|"Cetuximab plus bevacizumab~Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY~• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations~Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given"
1161235|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
1161282|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1163320|NCT00402987|O4|Outcome|Placebo|
1161068|NCT00409565|P1|Participant Flow|Cetuximab Plus Bevacizumab|"Cetuximab plus bevacizumab~Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY~• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations~Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given"
1161069|NCT00409565|O1|Outcome|Cetuximab Plus Bevacizumab|"Cetuximab plus bevacizumab~Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY~• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations~Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given"
1161070|NCT00409565|O1|Outcome|Cetuximab Plus Bevacizumab|"Cetuximab plus bevacizumab~Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY~• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations~Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given"
1161071|NCT00409565|O1|Outcome|Cetuximab Plus Bevacizumab|"Cetuximab plus bevacizumab~Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY~• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations~Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given"
1161072|NCT00409565|O1|Outcome|Cetuximab Plus Bevacizumab|"Cetuximab plus bevacizumab~Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY~• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations~Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given"
1161073|NCT00409565|O1|Outcome|Cetuximab Plus Bevacizumab|"Cetuximab plus bevacizumab~Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY~• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations~Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given"
1161114|NCT00409344|P1|Participant Flow|Saline|This group will recive saline
1161115|NCT00409344|O2|Outcome|Dexmedetomidine|This group will receive dexmedetomidine
1161076|NCT00409539|B5|Baseline|120mg Dose of SMP-986|"120mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
1161077|NCT00409539|B4|Baseline|80mg Dose of SMP-986|"80mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
1161078|NCT00409539|B3|Baseline|40mg Dose of SMP-986|"40mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
1161079|NCT00409539|B2|Baseline|20mg Dose of SMP-986|"20mg dose of SMP-986 to be taken once daily for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
1161080|NCT00409539|B1|Baseline|Placebo|"Placebo run-in phase. 2 week duration.~Placebo: Placebo, 2 week duration."
1161081|NCT00409539|P5|Participant Flow|120mg Dose of SMP-986|"120mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
1161082|NCT00409539|P4|Participant Flow|80mg Dose of SMP-986|"80mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
1161083|NCT00409539|P3|Participant Flow|40mg Dose of SMP-986|"40mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
1161084|NCT00409539|P2|Participant Flow|20mg Dose of SMP-986|"20mg dose of SMP-986 to be taken once daily for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
1161085|NCT00409539|P1|Participant Flow|Placebo|"Placebo run-in phase. 2 week duration.~Placebo: Placebo, 2 week duration."
1161086|NCT00409539|O5|Outcome|120mg Dose of SMP-986|"120mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
1161087|NCT00409539|O4|Outcome|80mg Dose of SMP-986|"80mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
1161088|NCT00409539|O3|Outcome|40mg Dose of SMP-986|"40mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
1161089|NCT00409539|O2|Outcome|20mg Dose of SMP-986|"20mg dose of SMP-986 to be taken once daily for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
1161090|NCT00409539|O1|Outcome|Placebo|"Placebo run-in phase. 2 week duration.~Placebo: Placebo, 2 week duration."
1161091|NCT00409539|O5|Outcome|120mg Dose of SMP-986|"120mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
1161092|NCT00409539|O4|Outcome|80mg Dose of SMP-986|"80mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
1161093|NCT00409539|O3|Outcome|40mg Dose of SMP-986|"40mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
1161094|NCT00409539|O2|Outcome|20mg Dose of SMP-986|"20mg dose of SMP-986 to be taken once daily for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
1161095|NCT00409539|O1|Outcome|Placebo|"Placebo run-in phase. 2 week duration.~Placebo: Placebo, 2 week duration."
1161097|NCT00409539|E4|Reported Event|80mg Dose of SMP-986|"80mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
1161098|NCT00409539|E3|Reported Event|40mg Dose of SMP-986|"40mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
1161099|NCT00409539|E2|Reported Event|20mg Dose of SMP-986|"20mg dose of SMP-986 to be taken once daily for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
1161100|NCT00409539|E1|Reported Event|Placebo|"Placebo run-in phase. 2 week duration.~Placebo: Placebo, 2 week duration."
1161101|NCT00409409|B3|Baseline|Total|Total of all reporting groups
1161102|NCT00409409|B2|Baseline|Placebo|Placebo tablet
1161103|NCT00409409|B1|Baseline|300 IR|300 IR grass pollen allergen extract tablet
1161104|NCT00409409|P2|Participant Flow|Placebo|Placebo tablet
1161105|NCT00409409|P1|Participant Flow|300 IR|300 IR grass pollen allergen extract tablet
1161106|NCT00409409|O2|Outcome|Placebo|Placebo tablet
1161107|NCT00409409|O1|Outcome|300 IR|300 IR grass pollen allergen extract tablet
1161108|NCT00409409|E2|Reported Event|Placebo|Placebo tablet
1161109|NCT00409409|E1|Reported Event|300 IR|300 IR grass pollen allergen extract tablet
1161110|NCT00409344|B3|Baseline|Total|Total of all reporting groups
1161111|NCT00409344|B2|Baseline|Dexmedetomidine|This group will receive dexmedetomidine
1161112|NCT00409344|B1|Baseline|Saline|This group will recive saline
1161113|NCT00409344|P2|Participant Flow|Dexmedetomidine|This group will receive dexmedetomidine
1161119|NCT00409344|O2|Outcome|Dexmedetomidine|This group will receive dexmedetomidine
1161120|NCT00409344|O1|Outcome|Saline|This group will recive saline
1161121|NCT00409344|O2|Outcome|Dexmedetomidine|This group will receive dexmedetomidine
1161122|NCT00409344|O1|Outcome|Saline|This group will recive saline
1161123|NCT00409344|O2|Outcome|Dexmedetomidine|This group will receive dexmedetomidine
1161124|NCT00409344|O1|Outcome|Saline|This group will recive saline
1161125|NCT00409344|O2|Outcome|Dexmedetomidine|This group will receive dexmedetomidine
1161126|NCT00409344|O1|Outcome|Saline|This group will recive saline
1161127|NCT00409344|O2|Outcome|Dexmedetomidine|This group will receive dexmedetomidine
1161128|NCT00409344|O1|Outcome|Saline|This group will recive saline
1161129|NCT00409344|E2|Reported Event|Dexmedetomidine|This group will receive dexmedetomidine
1161130|NCT00409344|E1|Reported Event|Saline|This group will recive saline
1161131|NCT00409331|B1|Baseline|IMRT + Amifostine|Intensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT.
1161132|NCT00409331|P1|Participant Flow|IMRT + Amifostine|Intensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT.
1161133|NCT00409331|O1|Outcome|IMRT + Amifostine|Intensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT.
1161134|NCT00409331|E1|Reported Event|IMRT + Amifostine|Intensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT.
1161135|NCT00409292|B1|Baseline|RAD001|RAD001: Taken orally daily for as long as the participant continues to receive a benefit.
1161136|NCT00409292|P1|Participant Flow|RAD001|"RAD001 was administered continuously at a dose of 10 mg daily by mouth until disease progression, unacceptable toxicity, or withdrawal of consent.~Four weeks of study drug was considered to be one cycle of treatment."
1161137|NCT00409292|O1|Outcome|RAD001|"RAD001 was administered continuously at a dose of 10 mg daily by mouth until disease progression, unacceptable toxicity, or withdrawal of consent.~Four weeks of study drug was considered to be one cycle of treatment.~RAD001: Taken orally daily for as long as the participant continues to receive a benefit."
1161138|NCT00409292|O1|Outcome|RAD001|RAD001: Taken orally daily for as long as the participant continues to receive a benefit.
1161139|NCT00409292|O1|Outcome|RAD001|RAD001: Taken orally daily for as long as the participant continues to receive a benefit.
1161140|NCT00409292|O1|Outcome|RAD001|RAD001 was administered continuously at a dose of 10 mg daily by mouth until disease progression, unacceptable toxicity, or withdrawal of consent.
1161141|NCT00409292|E1|Reported Event|RAD001|
1161142|NCT00409240|B3|Baseline|Total|Total of all reporting groups
1161143|NCT00409240|B2|Baseline|Usual Care|Patient continued on usual care
1161144|NCT00409240|B1|Baseline|MEDIC Intervention|"Receives pharmacist-led behavioral and pharmacologic group intervention for cardiac risk reduction~MEDIC: Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups."
1161145|NCT00409240|P2|Participant Flow|Usual Care|Patient continued on usual care
1161146|NCT00409240|P1|Participant Flow|MEDIC Intervention|"Receives pharmacist-led behavioral and pharmacologic group intervention for cardiac risk reduction~MEDIC: Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups."
1161147|NCT00409240|O2|Outcome|Usual Care|Patient continued on usual care
1161148|NCT00409240|O1|Outcome|MEDIC Intervention|"Receives pharmacist-led behavioral and pharmacologic group intervention for cardiac risk reduction~MEDIC: Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups."
1161149|NCT00409240|E2|Reported Event|Usual Care|Patient continued on usual care
1161150|NCT00409240|E1|Reported Event|MEDIC Intervention|"Receives pharmacist-led behavioral and pharmacologic group intervention for cardiac risk reduction~MEDIC: Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups."
1161151|NCT00409188|B3|Baseline|Total|Total of all reporting groups
1161152|NCT00409188|B2|Baseline|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
1161153|NCT00409188|B1|Baseline|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
1161154|NCT00409188|P2|Participant Flow|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
1161155|NCT00409188|P1|Participant Flow|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
1161588|NCT00408499|O1|Outcome|Dose Level 1|100 mg Erlotinib, 150 mg/m2 Cetuximab
1161156|NCT00409188|O2|Outcome|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
1161157|NCT00409188|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
1161158|NCT00409188|O2|Outcome|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
1161159|NCT00409188|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
1161160|NCT00409188|O2|Outcome|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
1161161|NCT00409188|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
1161162|NCT00409188|O2|Outcome|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
1161163|NCT00409188|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
1161164|NCT00409188|O2|Outcome|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
1161165|NCT00409188|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
1161166|NCT00409188|E2|Reported Event|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
1161167|NCT00409188|E1|Reported Event|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
1161168|NCT00409175|B3|Baseline|Total|Total of all reporting groups
1161169|NCT00409175|B2|Baseline|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
1161170|NCT00409175|B1|Baseline|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
1161171|NCT00409175|P2|Participant Flow|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
1161172|NCT00409175|P1|Participant Flow|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
1161173|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
1161174|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
1161175|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
1163396|NCT00402987|O2|Outcome|Celecoxib 100 mg (Pooled)|
1161176|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
1161177|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
1161178|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
1161179|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
1161180|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
1161181|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
1161182|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
1161183|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
1161184|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
1161185|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
1161186|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
1161187|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
1161188|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
1161189|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
1161190|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
1161191|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
1161192|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
1161193|NCT00409175|E2|Reported Event|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
1161194|NCT00409175|E1|Reported Event|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
1161195|NCT00409006|B3|Baseline|Total|Total of all reporting groups
1161196|NCT00409006|B2|Baseline|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
1161197|NCT00409006|B1|Baseline|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
1161198|NCT00409006|P2|Participant Flow|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
1161199|NCT00409006|P1|Participant Flow|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
1161200|NCT00409006|O2|Outcome|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
1161201|NCT00409006|O1|Outcome|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
1161236|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
1161202|NCT00409006|O2|Outcome|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
1161203|NCT00409006|O1|Outcome|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
1161204|NCT00409006|O2|Outcome|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
1161205|NCT00409006|O1|Outcome|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
1161206|NCT00409006|O2|Outcome|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
1161207|NCT00409006|O1|Outcome|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
1161249|NCT00408928|O1|Outcome|Bortezomib for Treatment of GHVD|Bortezomib at 1.3 mg/m2/dose given twice weekly for two weeks followed by a 10-day rest period. If patients have a complete response, they will receive additional cycles of bortezomib.
1161208|NCT00409006|O2|Outcome|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
1161209|NCT00409006|O1|Outcome|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
1161210|NCT00409006|E2|Reported Event|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
1161211|NCT00409006|E1|Reported Event|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
1161212|NCT00408993|B3|Baseline|Total|Total of all reporting groups
1161213|NCT00408993|B2|Baseline|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
1161214|NCT00408993|B1|Baseline|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
1161215|NCT00408993|P2|Participant Flow|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
1161216|NCT00408993|P1|Participant Flow|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
1161217|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
1161218|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
1161219|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
1161220|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
1161221|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
1161222|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
1161223|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
1161224|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
1161225|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
1161226|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
1161227|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
1161228|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
1161229|NCT00408993|O4|Outcome|Placebo - Evening Dosing|Placebo QD, PO for 12 weeks
1161230|NCT00408993|O3|Outcome|Placebo - Morning Dosing|Placebo QD, PO for 12 weeks
1161231|NCT00408993|O2|Outcome|Duloxetine - Evening Dosing|60 mg QD (morning or evening), PO for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
1161232|NCT00408993|O1|Outcome|Duloxetine - Morning Dosing|60 mg QD (morning or evening), PO for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
1161233|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
1163321|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
1161238|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
1161239|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
1161240|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
1161241|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
1161242|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
1161243|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
1161244|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
1161245|NCT00408993|E2|Reported Event|Duloxetine 60/120 mg QD|Duloxetine 60/120 mg QD
1161246|NCT00408993|E1|Reported Event|Placebo|Placebo
1161247|NCT00408928|B1|Baseline|Bortezomib for Treatment of GHVD|Bortezomib at 1.3 mg/m2/dose given twice weekly for two weeks followed by a 10-day rest period. If patients have a complete response, they will receive additional cycles of bortezomib.
1161248|NCT00408928|P1|Participant Flow|Bortezomib for Treatment of GHVD|Bortezomib at 1.3 mg/m2/dose given twice weekly for two weeks followed by a 10-day rest period. If patients have a complete response, they will receive additional cycles of bortezomib.
1161250|NCT00408928|O1|Outcome|Bortezomib for Treatment of GHVD|Bortezomib at 1.3 mg/m2/dose given twice weekly for two weeks followed by a 10-day rest period. If patients have a complete response, they will receive additional cycles of bortezomib.
1161251|NCT00408928|E1|Reported Event|Bortezomib for Treatment of GHVD|Bortezomib at 1.3 mg/m2/dose given twice weekly for two weeks followed by a 10-day rest period. If patients have a complete response, they will receive additional cycles of bortezomib.
1161252|NCT00408902|B1|Baseline|TandutinibTreatment|Patients receive oral tandutinib 500 mg twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1161253|NCT00408902|P1|Participant Flow|TandutinibTreatment|Patients receive oral tandutinib 500 mg twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1161254|NCT00408902|O1|Outcome|TandutinibTreatment|Patients receive oral tandutinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1161255|NCT00408902|O1|Outcome|TandutinibTreatment|Patients receive oral tandutinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1161256|NCT00408902|E1|Reported Event|TandutinibTreatment|"Patients receive oral tandutinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~tandutinib: Given orally~laboratory biomarker analysis: Correlative studies"
1161257|NCT00408876|B5|Baseline|Total|Total of all reporting groups
1161258|NCT00408876|B4|Baseline|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161259|NCT00408876|B3|Baseline|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161260|NCT00408876|B2|Baseline|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161261|NCT00408876|B1|Baseline|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161262|NCT00408876|P4|Participant Flow|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161263|NCT00408876|P3|Participant Flow|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161264|NCT00408876|P2|Participant Flow|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161265|NCT00408876|P1|Participant Flow|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161266|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161267|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161268|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161269|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161270|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161271|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161272|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161273|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161274|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161275|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161276|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161277|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161278|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161279|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161280|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161281|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161283|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161284|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161285|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161286|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161287|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161288|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161289|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161290|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161291|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161292|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161293|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161294|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161295|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161296|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161297|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161298|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161299|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161300|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161301|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161302|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161303|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161304|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161305|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161306|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161307|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161308|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161309|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161310|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161311|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161312|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161313|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161314|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161315|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161316|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161317|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161318|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161319|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161320|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161321|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161322|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161323|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161324|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161325|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161326|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161327|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161328|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161329|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161330|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1163322|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
1161331|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161332|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161333|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161334|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161335|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161336|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161337|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161338|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161339|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161340|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161341|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161342|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1163397|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1161343|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161344|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161345|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161346|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161347|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161348|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161349|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161350|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161351|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161352|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161353|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161354|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161355|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161356|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161357|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161358|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161359|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161360|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161361|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161362|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161363|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161364|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161365|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161366|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161367|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161368|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161369|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161370|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161371|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161372|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161373|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161374|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161375|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161376|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161377|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161378|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161379|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161380|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161381|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161382|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161383|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161384|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161385|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161386|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161387|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161388|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161389|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161390|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1163398|NCT00402987|O4|Outcome|Placebo|
1161391|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161392|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161393|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161394|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161395|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161396|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161397|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161398|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161399|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161400|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161401|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161402|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161403|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161404|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161405|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161406|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161407|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161408|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161409|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161410|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161411|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161412|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161413|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161414|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161415|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161416|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161417|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161418|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161419|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161420|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161421|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161422|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161423|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161424|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161425|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161426|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161427|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161428|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161429|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161430|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161431|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161432|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161433|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161434|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161435|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161436|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161437|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161438|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1163399|NCT00402987|O3|Outcome|Celecoxib 100mg / 50mg|
1161439|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161440|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161441|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161442|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161443|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161444|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161445|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161446|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161447|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161448|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161449|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161450|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161451|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161452|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161453|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161454|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161455|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161456|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161457|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161458|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161459|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161460|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161461|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161462|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161463|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161464|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161465|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161466|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161467|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161468|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161469|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161470|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161471|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161472|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161473|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161474|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161475|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161476|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161477|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161478|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161479|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161480|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161481|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161482|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161483|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161484|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161485|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161486|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1163400|NCT00402987|O2|Outcome|Celecoxib 100 mg / Placebo|
1161487|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161488|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161489|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161490|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161491|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161492|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161493|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161494|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161495|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161496|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161497|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161498|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161499|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161500|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161501|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161502|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161503|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161504|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161505|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161506|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161507|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161508|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161509|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161510|NCT00408876|E4|Reported Event|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
1161511|NCT00408876|E3|Reported Event|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
1161512|NCT00408876|E2|Reported Event|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
1161513|NCT00408876|E1|Reported Event|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
1161514|NCT00408694|B1|Baseline|Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)|"BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.~ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity."
1161541|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
1161542|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
1162072|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
1161515|NCT00408694|P1|Participant Flow|Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)|"BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.~ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity."
1161516|NCT00408694|O1|Outcome|Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)|"BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.~ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity."
1161517|NCT00408694|E1|Reported Event|Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)|"BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.~ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.~Data is reported for eligible patients with adverse event data who started study treatment, which is 44 patients."
1161518|NCT00408681|B1|Baseline|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
1161519|NCT00408681|P1|Participant Flow|Treated Patients|Patients receive oral lithium carbonate once or twice daily orally. Treatment continues for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
1161520|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
1161521|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
1161522|NCT00408681|O1|Outcome|Arm I|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
1161523|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
1161524|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
1161525|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
1161526|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
1161527|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
1161528|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
1161529|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
1161530|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
1161531|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
1161532|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
1161533|NCT00408681|O1|Outcome|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
1161534|NCT00408681|E1|Reported Event|Treated Patients|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
1161535|NCT00408629|B3|Baseline|Total|Total of all reporting groups
1161536|NCT00408629|B2|Baseline|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
1161537|NCT00408629|B1|Baseline|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
1161538|NCT00408629|P2|Participant Flow|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
1161539|NCT00408629|P1|Participant Flow|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
1161540|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
1161687|NCT00408200|B3|Baseline|Total|Total of all reporting groups
1161543|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
1161544|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
1161545|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
1161546|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
1161547|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
1161548|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
1161549|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
1161550|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
1161551|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
1161552|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
1161586|NCT00408499|O3|Outcome|Dose Level 3|100 mg Erlotinib, 250 mg/m2 Cetuximab
1161587|NCT00408499|O2|Outcome|Dose Level 2|100 mg Erlotinib, 200 mg/m2 Cetuximab
1161553|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
1161554|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
1161555|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
1161556|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
1161557|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
1161558|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
1161559|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
1161560|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
1161561|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
1161562|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
1161563|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
1161564|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
1161565|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
1161566|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
1161567|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
1161568|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
1161569|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
1161570|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
1161571|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
1161572|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
1161573|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
1161574|NCT00408629|E3|Reported Event|Any Adalimumab|During the Double-Blind period, only the Adalimumab treatment group received active study drug (dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 [160/80/40 mg]). After the switch to open-label treatment, participants in both treatment groups received adalimumab 40 mg eow, unless they dose-escalated, in which case they received adalimumab 40 mg every week (ew). Consequently, this analysis set combined adalimumab exposure from both the Double-Blind and Open-Label periods.
1161575|NCT00408629|E2|Reported Event|Placebo Group - Double-Blind Period|The placebo treatment group received placebo throughout the Double-Blind period.
1161576|NCT00408629|E1|Reported Event|Adalimumab Group - Double-Blind Period|During the Double-Blind period, the Adalimumab treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
1161704|NCT00407966|O1|Outcome|Arm A|Flavopiridol, ara-C, mitoxantrone
1161577|NCT00408499|B1|Baseline|Erlotinib + Cetuximab|"cetuximab: Cetuximab will be administered intravenously weekly at the maximum tolerated dose (determined in Phase I portion of the study) on a 28 day cycle. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy.~erlotinib: Erlotinib will be taken by mouth daily on a 28 day cycle. It is in tablet form. The dose will be determined in Phase I portion of the study. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy."
1161578|NCT00408499|P5|Participant Flow|Phase II- Dose Expansion|Phase II dose expansion at determined MTD
1161579|NCT00408499|P4|Participant Flow|Dose Level 4|150 mg Erlotinib, 250 mg/m2 Cetuximab
1161580|NCT00408499|P3|Participant Flow|Dose Level 3|100 mg Erlotinib, 250 mg/m2 Cetuximab
1161581|NCT00408499|P2|Participant Flow|Dose Level 2|100 mg Erlotinib, 200 mg/m2 Cetuximab
1161582|NCT00408499|P1|Participant Flow|Dose Level 1|100 mg Erlotinib, 150 mg/m2 Cetuximab
1161583|NCT00408499|O1|Outcome|Phase II Expansion|44 Patients at dose level 4 phase II expansion: 150 mg Erlotinib, 250 mg/m2 Cetuximab
1161584|NCT00408499|O1|Outcome|Erlotinib + Cetuximab|"cetuximab: Cetuximab will be administered intravenously weekly at the maximum tolerated dose (determined in Phase I portion of the study) on a 28 day cycle. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy.~erlotinib: Erlotinib will be taken by mouth daily on a 28 day cycle. It is in tablet form. The dose will be determined in Phase I portion of the study. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy."
1161585|NCT00408499|O4|Outcome|Dose Level 4|150 mg Erlotinib, 250 mg/m2 Cetuximab
1161589|NCT00408499|E1|Reported Event|Erlotinib + Cetuximab|"cetuximab: Cetuximab will be administered intravenously weekly at the maximum tolerated dose (determined in Phase I portion of the study) on a 28 day cycle. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy.~erlotinib: Erlotinib will be taken by mouth daily on a 28 day cycle. It is in tablet form. The dose will be determined in Phase I portion of the study. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy."
1161590|NCT00408460|B1|Baseline|Treatment (Enzyme Inhibitor, Chemotherapy)|"Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given PO~paclitaxel: Given IV~immunohistochemistry staining method: Optional correlative studies"
1161591|NCT00408460|P1|Participant Flow|Treatment (Enzyme Inhibitor, Chemotherapy)|"Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given PO~paclitaxel: Given IV~immunohistochemistry staining method: Optional correlative studies"
1161592|NCT00408460|O1|Outcome|Treatment (Enzyme Inhibitor, Chemotherapy)|"Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given PO~paclitaxel: Given IV~immunohistochemistry staining method: Optional correlative studies"
1161593|NCT00408460|O1|Outcome|Treatment (Enzyme Inhibitor, Chemotherapy)|"Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given PO~paclitaxel: Given IV~immunohistochemistry staining method: Optional correlative studies"
1161594|NCT00408460|O1|Outcome|Treatment (Enzyme Inhibitor, Chemotherapy)|"Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given PO~paclitaxel: Given IV~immunohistochemistry staining method: Optional correlative studies"
1161595|NCT00408460|E1|Reported Event|Treatment (Enzyme Inhibitor, Chemotherapy)|"Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given PO~paclitaxel: Given IV~immunohistochemistry staining method: Optional correlative studies"
1161596|NCT00408421|B3|Baseline|Total|Total of all reporting groups
1161597|NCT00408421|B2|Baseline|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161598|NCT00408421|B1|Baseline|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161599|NCT00408421|P3|Participant Flow|Duloxetine 120 mg|Beginning at Week 7, patients receiving duloxetine 60 mg daily (QD) were re-randomized to either duloxetine 60 mg QD or duloxetine 120 mg QD
1161600|NCT00408421|P2|Participant Flow|Duloxetine 60 mg|Patients randomly assigned to duloxetine 60 mg daily (QD) started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning at Week 7, patients on duloxetine 60 mg QD were re-randomized to either duloxetine 60 mg QD or duloxetine 120 mg QD.
1161601|NCT00408421|P1|Participant Flow|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161602|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161603|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161705|NCT00407966|E1|Reported Event|Arm A|Flavopiridol, ara-C, mitoxantrone
1163323|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1161604|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161605|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161606|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161607|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161608|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161609|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161610|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161611|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161717|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
1163401|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1161612|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161613|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161614|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161615|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161616|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161617|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161618|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161619|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161620|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161621|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161622|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161623|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161624|NCT00408421|O2|Outcome|Group 3 - Duloxetine 120mg|
1161625|NCT00408421|O1|Outcome|Group 2 - Duloxetine 60mg|
1161626|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161627|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161628|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161629|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161630|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161631|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1163324|NCT00402987|O3|Outcome|Placebo|
1161632|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161633|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161634|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161635|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161636|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161637|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161638|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161639|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161718|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
1162028|NCT00406783|E2|Reported Event|Placebo Tablet|placebo tablet, once daily for 15 days
1163402|NCT00402987|O3|Outcome|Placebo|
1161640|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161641|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161642|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161643|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161644|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161645|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161646|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161647|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161648|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161649|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161650|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161651|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161652|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161653|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161654|NCT00408421|O2|Outcome|Group 3 - Duloxetine 120mg|
1161655|NCT00408421|O1|Outcome|Group 2 - Duloxetine 60mg|
1161656|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161657|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161658|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161659|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161660|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161661|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161662|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161663|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161664|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161665|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161666|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161667|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161719|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
1162029|NCT00406783|E1|Reported Event|5-mg Desloratadine Tablet|5 mg desloratadine tablet, once daily for 15 days
1161668|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161669|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161670|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
1161671|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
1161672|NCT00408421|E2|Reported Event|Duloxetine 60/120 mg QD|Duloxetine 60/120 mg QD
1161673|NCT00408421|E1|Reported Event|Placebo|Placebo
1161674|NCT00408317|B1|Baseline|Entire Study Population|Includes all participants who received Ultrase® MT20 first and placebo first.
1161675|NCT00408317|P2|Participant Flow|Placebo First, Then Ultrase®MT20|Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in the first intervention period followed by Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in the second intervention period. Break period of 3 to 6 days and fixed dose second stabilization period of 4 days was maintained after first intervention period.
1161676|NCT00408317|P1|Participant Flow|Ultrase® MT20 First, Then Placebo|Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in the first intervention period followed by placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in the second intervention period. Break period of 3 to 6 days and fixed dose second stabilization period of 4 days was maintained after first intervention period.
1161677|NCT00408317|O2|Outcome|Placebo|Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in either first intervention period or second intervention period.
1161678|NCT00408317|O1|Outcome|Ultrase® MT20|Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in either first intervention period or second intervention period.
1161679|NCT00408317|O2|Outcome|Placebo|Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in either first intervention period or second intervention period.
1161680|NCT00408317|O1|Outcome|Ultrase® MT20|Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in either first intervention period or second intervention period.
1161681|NCT00408317|O2|Outcome|Placebo|Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in either first intervention period or second intervention period.
1161682|NCT00408317|O1|Outcome|Ultrase® MT20|Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in either first intervention period or second intervention period.
1161683|NCT00408317|O2|Outcome|Placebo|Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in either first intervention period or second intervention period.
1161684|NCT00408317|O1|Outcome|Ultrase® MT20|Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in either first intervention period or second intervention period.
1161685|NCT00408317|E2|Reported Event|Placebo|Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in either first intervention period or second intervention period.
1161686|NCT00408317|E1|Reported Event|Ultrase® MT20|Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion,for 6 to 7 days in either first intervention period or second intervention period.
1161688|NCT00408200|B2|Baseline|AAD:YES|"Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.~propafenone; flecainide; sotalol; dofetilide : Above drugs prescribed per established guidelines for treatment of AF"
1161689|NCT00408200|B1|Baseline|AAD:NO|"Subjects do not receive membrane-active anti-arrhythmic medications after ablation.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates."
1161690|NCT00408200|P2|Participant Flow|AAD:YES|"Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.~propafenone; flecainide; sotalol; dofetilide : Above drugs prescribed per established guidelines for treatment of AF"
1161691|NCT00408200|P1|Participant Flow|AAD:NO|"Subjects do not receive membrane-active anti-arrhythmic medications after ablation.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates."
1161742|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1162030|NCT00406718|B4|Baseline|Total|Total of all reporting groups
1161692|NCT00408200|O2|Outcome|AAD:YES|"Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.~propafenone; flecainide; sotalol; dofetilide : Above drugs prescribed per established guidelines for treatment of AF"
1161693|NCT00408200|O1|Outcome|AAD:NO|"Subjects do not receive membrane-active anti-arrhythmic medications after ablation.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates."
1161694|NCT00408200|O2|Outcome|AAD:YES|"Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.~propafenone; flecainide; sotalol; dofetilide : Above drugs prescribed per established guidelines for treatment of AF"
1161695|NCT00408200|O1|Outcome|AAD:NO|"Subjects do not receive membrane-active anti-arrhythmic medications after ablation.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates."
1161696|NCT00408200|E2|Reported Event|AAD:YES|"Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.~propafenone; flecainide; sotalol; dofetilide : Above drugs prescribed per established guidelines for treatment of AF"
1161697|NCT00408200|E1|Reported Event|AAD:NO|"Subjects do not receive membrane-active anti-arrhythmic medications after ablation.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates."
1161698|NCT00408070|B1|Baseline|Bevacizumab Plus Carboplatin and Paclitaxel|This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
1161699|NCT00408070|P1|Participant Flow|Bevacizumab Plus Carboplatin and Paclitaxel|This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
1161700|NCT00408070|O1|Outcome|Bevacizumab Plus Carboplatin and Paclitaxel|This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
1161701|NCT00408070|E1|Reported Event|Bevacizumab Plus Carboplatin and Paclitaxel|This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
1161702|NCT00407966|B1|Baseline|Arm A|Flavopiridol, ara-C, mitoxantrone
1161703|NCT00407966|P1|Participant Flow|Arm A|Flavopiridol, ara-C, mitoxantrone
1161706|NCT00407797|B1|Baseline|Pregabalin|150 mg per day as two doses (75 mg twice daily; BID), increased to 600 mg per day (300 mg BID) as needed based on response and tolerability
1161707|NCT00407797|P1|Participant Flow|Pregabalin|150 mg per day as two doses (75 mg twice daily; BID), increased to 600 mg per day (300 mg BID) as needed based on response and tolerability
1161708|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
1161709|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
1161710|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
1161711|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
1161712|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
1161713|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
1161714|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
1161715|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
1161716|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
1161720|NCT00407797|E1|Reported Event|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
1161721|NCT00407745|B3|Baseline|Total|Total of all reporting groups
1161722|NCT00407745|B2|Baseline|Placebo|Placebo matching study treatment.
1161723|NCT00407745|B1|Baseline|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161724|NCT00407745|P2|Participant Flow|Placebo|Placebo matching study treatment.
1161725|NCT00407745|P1|Participant Flow|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161726|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1161727|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161728|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1161729|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161730|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1161731|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161732|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1161733|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161734|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1161827|NCT00407537|B1|Baseline|Caduet as Assigned|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
1161828|NCT00407537|P2|Participant Flow|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
1163325|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
1161735|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161736|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1161737|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161738|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1161739|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161740|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1161741|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161743|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161744|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1161745|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161746|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1161747|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161748|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1161749|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161750|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1161751|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161752|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1161753|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161754|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1161829|NCT00407537|P1|Participant Flow|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
1162073|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
1161755|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161756|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1161757|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161758|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1161759|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161760|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1161761|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161762|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1161805|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~aflibercept: Given intravenously"
1163022|NCT00404092|E1|Reported Event|1st Cohort|"70mg 1x/day~caspofungin : i.v."
1161763|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161764|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1161765|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161766|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1161767|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161768|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1161769|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161770|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1161771|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161772|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1161773|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161774|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1161775|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161776|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1161777|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161778|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1161779|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161780|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1161781|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161782|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1161806|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given intravenously~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1161783|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161784|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1161785|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161786|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1161787|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161788|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1161789|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161790|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1161791|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161792|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
1161793|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161794|NCT00407745|E2|Reported Event|Placebo|Placebo matching study treatment.
1161795|NCT00407745|E1|Reported Event|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
1161796|NCT00407654|B1|Baseline|Arm I|"Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1161797|NCT00407654|P1|Participant Flow|VEGF Trap IV Arm I|"Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given intravenously~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1161798|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~aflibercept: Given intravenously"
1161799|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~aflibercept: Given intravenously"
1161800|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~aflibercept: Given intravenously"
1161801|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~aflibercept: Given intravenously"
1161802|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~aflibercept: Given intravenously"
1161803|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~aflibercept: Given intravenously"
1161804|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given intravenously~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1163023|NCT00404079|B3|Baseline|Total|Total of all reporting groups
1161807|NCT00407654|E1|Reported Event|Arm I|"Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1161808|NCT00407563|B1|Baseline|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
1161809|NCT00407563|P1|Participant Flow|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
1161810|NCT00407563|O1|Outcome|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
1161811|NCT00407563|O1|Outcome|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
1161812|NCT00407563|O1|Outcome|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
1161813|NCT00407563|O1|Outcome|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
1161814|NCT00407563|O1|Outcome|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
1161815|NCT00407563|E1|Reported Event|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
1161816|NCT00407550|B3|Baseline|Total|Total of all reporting groups
1161817|NCT00407550|B2|Baseline|Gemzar x1|Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.
1161818|NCT00407550|B1|Baseline|Gemzar x2|Treat subjects with 2 dosings/cycle of Gemzar x6 cycles.
1161819|NCT00407550|P2|Participant Flow|Gemzar x1|Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.
1161820|NCT00407550|P1|Participant Flow|Gemzar x2|Treat subjects with 2 dosings/cycle of Gemzar x6 cycles.
1161821|NCT00407550|O2|Outcome|Gemzar x1|Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.
1161822|NCT00407550|O1|Outcome|Gemzar x2|Treat subjects with 2 dosings/cycle of Gemzar x6 cycles.
1161823|NCT00407550|E2|Reported Event|Gemzar x1|Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.
1161824|NCT00407550|E1|Reported Event|Gemzar x2|Treat subjects with 2 dosings/cycle of Gemzar x6 cycles.
1161825|NCT00407537|B3|Baseline|Total|Total of all reporting groups
1161826|NCT00407537|B2|Baseline|Usual Care as Assigned|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
1161830|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
1161831|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
1161832|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
1161833|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
1161834|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
1161835|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
1161836|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
1161837|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
1161838|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
1161839|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
1161840|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
1161841|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
1161842|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
1161843|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
1161844|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
1161845|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
1161846|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
1161847|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
1161848|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
1161849|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
1161850|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
1161851|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
1161852|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
1161853|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
1161854|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
1161855|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
1161856|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
1161857|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
1161858|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
1161859|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
1161950|NCT00406848|B3|Baseline|Total|Total of all reporting groups
1162894|NCT00404547|O2|Outcome|Usual Asthma Care and Dosage|as chosen by the Primary Care Physician
1161860|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
1161861|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
1161862|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
1161863|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
1161864|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
1161865|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
1161866|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
1161867|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
1161868|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
1161869|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
1162019|NCT00406783|P1|Participant Flow|5-mg Desloratadine Tablet|5 mg desloratadine tablet, once daily for 15 days
1163403|NCT00402987|O2|Outcome|Celecoxib 100 mg (Pooled)|
1161870|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
1161871|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
1161872|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
1161873|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
1161874|NCT00407537|E2|Reported Event|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
1161875|NCT00407537|E1|Reported Event|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
1161876|NCT00407511|B1|Baseline|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
1161877|NCT00407511|P1|Participant Flow|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
1161878|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
1161879|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
1161880|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
1161881|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
1162074|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
1162895|NCT00404547|O1|Outcome|Alvesco|320 mcg/day or 640 mcg/day
1161882|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
1161883|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
1161884|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
1161885|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
1161886|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
1162020|NCT00406783|O2|Outcome|Placebo Tablet|placebo tablet, once daily for 15 days
1162021|NCT00406783|O1|Outcome|5-mg Desloratadine Tablet|5 mg desloratadine tablet, once daily for 15 days
1161887|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
1161888|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
1161889|NCT00407511|E1|Reported Event|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
1161890|NCT00407485|B1|Baseline|Treatment (Ziv-aflibercept)|"Patients receive 4 mg/kg VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
1161891|NCT00407485|P1|Participant Flow|Treatment (Ziv-aflibercept)|"Patients receive 4 mg/kg VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
1161892|NCT00407485|O1|Outcome|Treatment (Ziv-aflibercept)|"Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
1161893|NCT00407485|O1|Outcome|Treatment (Ziv-aflibercept)|"Patients receive 4 mg/kg VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
1161894|NCT00407485|E1|Reported Event|Treatment (Ziv-aflibercept)|"Patients receive 4 mg/kg VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
1161895|NCT00407381|B4|Baseline|Total|Total of all reporting groups
1161896|NCT00407381|B3|Baseline|Laser With RBZ|"Laser following intravitreal injection of RBZ~Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria.~Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator."
1161897|NCT00407381|B2|Baseline|Laser Only|"Laser photocoagulation~Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator."
1161898|NCT00407381|B1|Baseline|Ranibizumab Only|"RBZ intravitreal injection alone~Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria."
1161899|NCT00407381|P3|Participant Flow|Laser With Ranibizumab (RBZ)|"Laser following intravitreal injection of RBZ~Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria.~Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator."
1161900|NCT00407381|P2|Participant Flow|Laser Only|"Laser photocoagulation~Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator."
1161901|NCT00407381|P1|Participant Flow|Ranibizumab Only|"Ranibizumab (RBZ) intravitreal injection alone~Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and pro re nata (PRN) with dosing criteria."
1161902|NCT00407381|O3|Outcome|Laser With RBZ|"Laser following intravitreal injection of RBZ~Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria.~Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator."
1161903|NCT00407381|O2|Outcome|Laser Alone|"Laser photocoagulation~Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator."
1161904|NCT00407381|O1|Outcome|RBZ Alone|"RBZ intravitreal injection alone~Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria."
1161905|NCT00407381|E3|Reported Event|Laser With Ranibizumab|"Laser following intravitreal injection of RBZ~Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria.~Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator."
1161906|NCT00407381|E2|Reported Event|Laser Only|"Laser photocoagulation~Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator."
1161907|NCT00407381|E1|Reported Event|Ranibizumab Only|"RBZ intravitreal injection alone~Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria."
1161908|NCT00407355|B3|Baseline|Total|Total of all reporting groups
1161909|NCT00407355|B2|Baseline|BRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
1161910|NCT00407355|B1|Baseline|CRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
1161911|NCT00407355|P2|Participant Flow|BRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
1161912|NCT00407355|P1|Participant Flow|CRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
1161913|NCT00407355|O2|Outcome|BRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
1161914|NCT00407355|O1|Outcome|CRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
1161915|NCT00407355|O2|Outcome|BRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
1161916|NCT00407355|O1|Outcome|CRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
1161917|NCT00407355|E2|Reported Event|BRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
1161918|NCT00407355|E1|Reported Event|CRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
1161919|NCT00407030|B4|Baseline|Total|Total of all reporting groups
1161920|NCT00407030|B3|Baseline|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1161921|NCT00407030|B2|Baseline|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
1161922|NCT00407030|B1|Baseline|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
1161923|NCT00407030|P3|Participant Flow|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1161924|NCT00407030|P2|Participant Flow|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
1161925|NCT00407030|P1|Participant Flow|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
1161926|NCT00407030|O2|Outcome|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
1161927|NCT00407030|O1|Outcome|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
1161928|NCT00407030|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1162075|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
1161929|NCT00407030|O1|Outcome|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
1161930|NCT00407030|O3|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1161931|NCT00407030|O2|Outcome|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
1161932|NCT00407030|O1|Outcome|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
1161933|NCT00407030|O3|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1161934|NCT00407030|O2|Outcome|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
1161935|NCT00407030|O1|Outcome|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
1161936|NCT00407030|O3|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1162022|NCT00406783|O2|Outcome|Placebo Tablet|placebo tablet, once daily for 15 days
1162023|NCT00406783|O1|Outcome|5-mg Desloratadine Tablet|5 mg desloratadine tablet, once daily for 15 days
1161937|NCT00407030|O2|Outcome|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
1161938|NCT00407030|O1|Outcome|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
1161939|NCT00407030|O3|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1161940|NCT00407030|O2|Outcome|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
1161941|NCT00407030|O1|Outcome|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
1161942|NCT00407030|O3|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1161943|NCT00407030|O2|Outcome|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
1161944|NCT00407030|O1|Outcome|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
1161945|NCT00407030|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1161946|NCT00407030|O1|Outcome|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
1161947|NCT00407030|E3|Reported Event|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
1161948|NCT00407030|E2|Reported Event|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
1161949|NCT00407030|E1|Reported Event|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
1161951|NCT00406848|B2|Baseline|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
1161952|NCT00406848|B1|Baseline|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
1161953|NCT00406848|P2|Participant Flow|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
1161954|NCT00406848|P1|Participant Flow|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
1161955|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
1162024|NCT00406783|O2|Outcome|Placebo Tablet|placebo tablet, once daily for 15 days
1162025|NCT00406783|O1|Outcome|5-mg Desloratadine Tablet|5 mg desloratadine tablet, once daily for 15 days
1162026|NCT00406783|O2|Outcome|Placebo Tablet|placebo tablet, once daily for 15 days
1161956|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
1161957|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
1161958|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
1161959|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
1161960|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
1161961|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
1161962|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
1161963|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
1161964|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
1162076|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
1162896|NCT00404547|E2|Reported Event|Usual Asthma Care and Dosage|as chosen by the Primary Care Physician
1161965|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
1161966|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
1161967|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
1161968|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
1161969|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
1161970|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
1162027|NCT00406783|O1|Outcome|5-mg Desloratadine Tablet|5 mg desloratadine tablet, once daily for 15 days
1161971|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
1161972|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
1161973|NCT00406848|O3|Outcome|Placebo Rescue|Participants who were randomized to placebo at baseline and for whom rescue treatment was required during the continuation phase. Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which they were rescued to duloxetine 60 milligrams (mg) orally once daily (QD) beginning with duloxetine 30 mg QD orally for one week followed by duloxetine 60 mg QD orally until completing or discontinuing from the study.
1161974|NCT00406848|O2|Outcome|Placebo Non-rescue|Participants who were randomized to placebo at baseline and for whom treatment rescue was not required during continuation phase. Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which they continued to receive placebo until completing or discontinuing from the study.
1161975|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
1161976|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
1161977|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
1161978|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
1162040|NCT00406718|O3|Outcome|Standard|"Participants will receive standard treatment~Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function."
1162077|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
1161979|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
1161980|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
1161981|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
1161982|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
1161983|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
1161984|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
1161985|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
1163404|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1161986|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
1161987|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
1161988|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
1161989|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
1161990|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
1161991|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
1161992|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
1161993|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
1161994|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
1161995|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
1161996|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
1161997|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
1161998|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
1161999|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
1162000|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
1163405|NCT00402987|O4|Outcome|Placebo|
1162001|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
1162002|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
1162003|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
1162004|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
1162005|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
1162006|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
1162007|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
1162008|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
1162009|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
1162010|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
1162011|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
1162012|NCT00406848|E3|Reported Event|Rescued Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants were rescued to duloxetine 60 milligrams (mg) orally once daily (QD) beginning with duloxetine 30 mg QD orally for one week followed by duloxetine 60 mg QD orally for the remainder of the study. Results are for the randomized placebo patients who were rescued to duloxetine and reported events while they were on duloxetine.
1162013|NCT00406848|E2|Reported Event|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity. Results are for the randomized placebo patients who reported events while they were on placebo.
1162014|NCT00406848|E1|Reported Event|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
1162015|NCT00406783|B3|Baseline|Total|Total of all reporting groups
1162016|NCT00406783|B2|Baseline|Placebo Tablet|placebo tablet, once daily for 15 days
1162017|NCT00406783|B1|Baseline|5-mg Desloratadine Tablet|5 mg desloratadine tablet, once daily for 15 days
1162018|NCT00406783|P2|Participant Flow|Placebo Tablet|placebo tablet, once daily for 15 days
1162031|NCT00406718|B3|Baseline|Standard Treatment|"Participants will receive standard treatment~Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function."
1162032|NCT00406718|B2|Baseline|Med-eMonitor|"Participants will receive the Med-eMonitor™~Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed."
1162033|NCT00406718|B1|Baseline|PharmCAT|"Participants will receive PharmCAT~PharmCAT Therapy: Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager."
1162034|NCT00406718|P3|Participant Flow|Treatment as Usual|"standard treatment~Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function."
1162035|NCT00406718|P2|Participant Flow|Med-eMonitor|"Participants will receive the Med-eMonitor™~Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed."
1162036|NCT00406718|P1|Participant Flow|Pharm CAT|Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager.
1162037|NCT00406718|O3|Outcome|Treatment as Usual|"standard treatment~Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function."
1162038|NCT00406718|O2|Outcome|Med-eMonitor|"Participants will receive the Med-eMonitor™~Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed."
1162039|NCT00406718|O1|Outcome|Pharm CAT|Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager.
1162078|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
1162041|NCT00406718|O2|Outcome|Med-eMonitor|"Participants will receive the Med-eMonitor™~Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed."
1162042|NCT00406718|O1|Outcome|PharmCAT|"Participants will receive PharmCAT~PharmCAT Therapy: Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager."
1162043|NCT00406718|O3|Outcome|Standard|"Participants will receive standard treatment~Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function."
1162044|NCT00406718|O2|Outcome|Med-eMonitor|"Participants will receive the Med-eMonitor™~Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed."
1162045|NCT00406718|O1|Outcome|PharmCAT|"Participants will receive PharmCAT~PharmCAT Therapy: Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager."
1162046|NCT00406718|E3|Reported Event|Standard Treatment|"Participants will receive standard treatment~Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function."
1162047|NCT00406718|E2|Reported Event|Med-eMonitor|"Participants will receive the Med-eMonitor™~Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed."
1162093|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
1162094|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
1162048|NCT00406718|E1|Reported Event|PharmCAT|"Participants will receive PharmCAT~PharmCAT Therapy: Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager."
1162049|NCT00406692|B1|Baseline|Zonisamide|400 mg daily
1162050|NCT00406692|P1|Participant Flow|Zonisamide|400 mg daily
1162051|NCT00406692|O1|Outcome|Zonisamide|400 mg daily
1162052|NCT00406692|O1|Outcome|Zonisamide|400 mg daily
1162053|NCT00406692|O1|Outcome|Zonisamide|400 mg daily
1162054|NCT00406692|E1|Reported Event|Zonisamide|400 mg daily
1162055|NCT00406653|B5|Baseline|Total|Total of all reporting groups
1162056|NCT00406653|B4|Baseline|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1162057|NCT00406653|B3|Baseline|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
1162058|NCT00406653|B2|Baseline|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
1162059|NCT00406653|B1|Baseline|ABA 30/~10 mg/kg, Induction Period (IP)|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
1162060|NCT00406653|P7|Participant Flow|ABA ~10 mg/kg, Open-Label Period (OL)|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
1162061|NCT00406653|P6|Participant Flow|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
1162062|NCT00406653|P5|Participant Flow|ABA ~10 mg/kg, Maintenance Period (MP)|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
1162063|NCT00406653|P4|Participant Flow|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1162064|NCT00406653|P3|Participant Flow|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
1162065|NCT00406653|P2|Participant Flow|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
1162066|NCT00406653|P1|Participant Flow|Abatacept (ABA) 30/~10 mg/kg, Induction Period (IP)|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
1162067|NCT00406653|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
1162068|NCT00406653|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
1162069|NCT00406653|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
1162070|NCT00406653|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
1162897|NCT00404547|E1|Reported Event|Alvesco|320 mcg/day or 640 mcg/day
1162079|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
1162080|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
1162081|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
1162082|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
1162083|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
1162084|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
1162085|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
1162086|NCT00406653|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
1162087|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
1162088|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
1162089|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
1162090|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
1162091|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
1162092|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
1162095|NCT00406653|O4|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
1162096|NCT00406653|O3|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
1162097|NCT00406653|O2|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
1162098|NCT00406653|O1|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1162099|NCT00406653|O4|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1162100|NCT00406653|O3|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
1162101|NCT00406653|O2|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
1162102|NCT00406653|O1|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
1162103|NCT00406653|O4|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1162104|NCT00406653|O3|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
1162105|NCT00406653|O2|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
1162106|NCT00406653|O1|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
1162107|NCT00406653|O3|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
1162108|NCT00406653|O2|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
1162109|NCT00406653|O1|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
1162110|NCT00406653|O4|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1162111|NCT00406653|O3|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
1162112|NCT00406653|O2|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
1162113|NCT00406653|O1|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
1162114|NCT00406653|O4|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1162115|NCT00406653|O3|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
1162116|NCT00406653|O2|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
1162898|NCT00404495|B3|Baseline|Total|Total of all reporting groups
1162117|NCT00406653|O1|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
1162118|NCT00406653|O4|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1162119|NCT00406653|O3|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
1162120|NCT00406653|O2|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
1162121|NCT00406653|O1|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
1162122|NCT00406653|O4|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
1162123|NCT00406653|O3|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
1162124|NCT00406653|O2|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
1162125|NCT00406653|O1|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1162126|NCT00406653|O4|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1163406|NCT00402987|O3|Outcome|Celecoxib 100mg / 50mg|
1162127|NCT00406653|O3|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
1162128|NCT00406653|O2|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
1162129|NCT00406653|O1|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
1162130|NCT00406653|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
1162131|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
1162132|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
1162133|NCT00406653|O4|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1162134|NCT00406653|O3|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
1162135|NCT00406653|O2|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
1162136|NCT00406653|O1|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
1162137|NCT00406653|E7|Reported Event|Placebo (MP)|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
1162138|NCT00406653|E6|Reported Event|Placebo (IP)|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
1162139|NCT00406653|E5|Reported Event|ABA ~10mg/kg (OL)|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
1162140|NCT00406653|E4|Reported Event|ABA ~10mg/kg (MP)|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
1162141|NCT00406653|E3|Reported Event|ABA ~10mg/kg (IP)|During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
1162142|NCT00406653|E2|Reported Event|ABA 3mg/kg (IP)|During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
1162143|NCT00406653|E1|Reported Event|ABA 30/~10mg/kg (IP)|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
1162144|NCT00406640|B3|Baseline|Total|Total of all reporting groups
1162145|NCT00406640|B2|Baseline|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
1162221|NCT00406367|E2|Reported Event|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl;Mode of administration: intramuscular injection
1162222|NCT00406367|E1|Reported Event|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1162223|NCT00406354|B4|Baseline|Total|Total of all reporting groups
1162146|NCT00406640|B1|Baseline|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
1162147|NCT00406640|P2|Participant Flow|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
1162148|NCT00406640|P1|Participant Flow|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
1162198|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
1162199|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
1162149|NCT00406640|O2|Outcome|Escitalopram (ESC)|Taper Phase Day 239 or at discontinuation: If patients taking escitalopram 20 mg/day, then decrease to 10 mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10 mg/day decreased to matching escitalopram placebo/day for 7 days.
1162150|NCT00406640|O1|Outcome|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
1162151|NCT00406640|O2|Outcome|ESC Non-Responders / DVS SR OL|Patients who received ESC during the acute double blind phase (weeks 1-8), did not achieve a response to treatment (response defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase; entered into open label (OL) treatment with DVS SR during 6-month Open Label Extension phase.
1162152|NCT00406640|O1|Outcome|DVS SR Non-Responders / DVS SR OL|Patients who received DVS SR during the acute double blind phase (weeks 1-8), did not achieve a response to treatment (response defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase; entered into open label (OL) treatment with DVS SR during 6-month Open Label Extension phase.
1162153|NCT00406640|O2|Outcome|ESC Non-Responders / DVS SR OL|Patients who received ESC during the acute double blind phase (weeks 1-8), did not achieve a response to treatment (response defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase; entered into open label (OL) treatment with DVS SR during 6-month Open Label Extension phase.
1162154|NCT00406640|O1|Outcome|DVS SR Non-Responders / DVS SR OL|Patients who received DVS SR during the acute double blind phase (weeks 1-8), did not achieve a response to treatment (response defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase; entered into open label (OL) treatment with DVS SR during 6-month Open Label Extension phase.
1162155|NCT00406640|O2|Outcome|ESC Responders / ESC DB|Patients who received ESC during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on ESC during the 6-month Double Blind Continuation phase.
1162156|NCT00406640|O1|Outcome|DVS SR Responders / DVS SR DB|Patients who received DVS SR during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on DVS SR during the 6-month Double Blind Continuation phase.
1162157|NCT00406640|O2|Outcome|ESC Responders / ESC DB|Patients who received ESC during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on ESC during the 6-month Double Blind Continuation phase.
1162158|NCT00406640|O1|Outcome|DVS SR Responders / DVS SR DB|Patients who received DVS SR during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on DVS SR during the 6-month Double Blind Continuation phase.
1162159|NCT00406640|O2|Outcome|ESC Responders / ESC DB|Patients who received ESC during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on ESC during the 6-month Double Blind Continuation phase.
1162160|NCT00406640|O1|Outcome|DVS SR Responders / DVS SR DB|Patients who received DVS SR during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on DVS SR during the 6-month Double Blind Continuation phase.
1162224|NCT00406354|B3|Baseline|Placebo|matching placebo daily dose taken orally
1162225|NCT00406354|B2|Baseline|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
1163066|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
1162161|NCT00406640|O2|Outcome|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
1162162|NCT00406640|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
1162163|NCT00406640|O2|Outcome|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
1162200|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
1162201|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
1162202|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
1162203|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
1162164|NCT00406640|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
1162165|NCT00406640|O2|Outcome|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
1162166|NCT00406640|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
1162167|NCT00406640|O2|Outcome|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
1162226|NCT00406354|B1|Baseline|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
1162227|NCT00406354|P3|Participant Flow|Placebo|matching placebo daily dose taken orally
1162228|NCT00406354|P2|Participant Flow|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
1162168|NCT00406640|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
1162169|NCT00406640|O2|Outcome|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
1162170|NCT00406640|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
1162171|NCT00406640|O2|Outcome|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
1162204|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
1163407|NCT00402987|O2|Outcome|Celecoxib 100 mg / Placebo|
1162172|NCT00406640|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
1162173|NCT00406640|O2|Outcome|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
1162174|NCT00406640|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
1162175|NCT00406640|E2|Reported Event|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
1162176|NCT00406640|E1|Reported Event|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
1162177|NCT00406393|B3|Baseline|Total|Total of all reporting groups
1162178|NCT00406393|B2|Baseline|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
1162179|NCT00406393|B1|Baseline|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
1162180|NCT00406393|P2|Participant Flow|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
1162181|NCT00406393|P1|Participant Flow|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
1162182|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
1162183|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
1162184|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
1162185|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
1162186|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
1162187|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
1162188|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
1162189|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
1162190|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
1162191|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
1162192|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
1162193|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
1162194|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
1162195|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
1162196|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
1162197|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
1163408|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1162205|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
1162206|NCT00406393|E2|Reported Event|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
1162207|NCT00406393|E1|Reported Event|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
1162208|NCT00406367|B3|Baseline|Total|Total of all reporting groups
1162209|NCT00406367|B2|Baseline|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl;Mode of administration: intramuscular injection
1162210|NCT00406367|B1|Baseline|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1162211|NCT00406367|P2|Participant Flow|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl;Mode of administration: intramuscular injection
1162212|NCT00406367|P1|Participant Flow|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1162213|NCT00406367|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl;Mode of administration: intramuscular injection
1162214|NCT00406367|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1162215|NCT00406367|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl;Mode of administration: intramuscular injection
1162216|NCT00406367|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1162217|NCT00406367|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl;Mode of administration: intramuscular injection
1162218|NCT00406367|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1162219|NCT00406367|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl;Mode of administration: intramuscular injection
1162220|NCT00406367|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
1163326|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1162229|NCT00406354|P1|Participant Flow|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
1162230|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
1162231|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
1162232|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
1162233|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
1162234|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
1162235|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
1162236|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
1162237|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
1162238|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
1162239|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
1162240|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
1162241|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
1162242|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
1162287|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
1162243|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
1162244|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
1162245|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
1162246|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
1162247|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
1162248|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
1162249|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
1162250|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
1162251|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
1162252|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
1162253|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
1162254|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
1162255|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
1162256|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
1162257|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
1162258|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
1162259|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
1162260|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
1162261|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
1162262|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
1162263|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
1162264|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
1162265|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
1162266|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
1162267|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
1162268|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
1162269|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
1162270|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
1162271|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
1162272|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
1162273|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
1162274|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
1162275|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
1162276|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
1162277|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
1162278|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
1162279|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
1162280|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
1162281|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
1162282|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
1162283|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
1162284|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
1162285|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
1162286|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
1162288|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
1162289|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
1162290|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
1162291|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
1162292|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
1162293|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
1162294|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
1162295|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
1162296|NCT00406354|E3|Reported Event|Placebo|matching placebo daily dose taken orally
1162297|NCT00406354|E2|Reported Event|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
1162298|NCT00406354|E1|Reported Event|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
1162299|NCT00406315|B1|Baseline|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
1162300|NCT00406315|P1|Participant Flow|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
1162301|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
1162302|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
1162303|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
1162304|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
1162325|NCT00405067|B1|Baseline|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
1162305|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
1162306|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
1162307|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
1162308|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
1162309|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
1162337|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
1163409|NCT00402987|O3|Outcome|Placebo|
1162310|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
1162311|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
1162312|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
1162313|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
1162314|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
1162315|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
1162316|NCT00406315|E1|Reported Event|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
1162317|NCT00406276|B1|Baseline|RAD001+Docetaxel|Docetaxel 60 mg/m^2 given intravenously over 60 minutes on day 1 of each cycle. RAD 001 5 mg by mouth once a day on days 1-19 of each cycle.
1162318|NCT00406276|P1|Participant Flow|RAD001+Docetaxel|Docetaxel 60 mg/m^2 given intravenously over 60 minutes on day 1 of each cycle. RAD 001 5 mg by mouth once a day on days 1-19 of each cycle.
1162319|NCT00406276|O1|Outcome|Docetaxel/RAD001|
1162320|NCT00406276|O1|Outcome|Docetaxel/RAD001|Docetaxel 60 mg/m^2 given intravenously over 60 minutes on day 1 of each cycle. RAD 001 5 mg by mouth once a day on days 1-19 of each cycle.
1162321|NCT00406276|E1|Reported Event|RAD001+Docetaxel|Docetaxel 60 mg/m^2 given intravenously over 60 minutes on day 1 of each cycle. RAD 001 5 mg by mouth once a day on days 1-19 of each cycle.
1162322|NCT00405067|B4|Baseline|Total|Total of all reporting groups
1162323|NCT00405067|B3|Baseline|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
1162324|NCT00405067|B2|Baseline|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
1163327|NCT00402987|O4|Outcome|Placebo|
1162326|NCT00405067|P3|Participant Flow|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
1162327|NCT00405067|P2|Participant Flow|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
1162328|NCT00405067|P1|Participant Flow|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
1162329|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
1162330|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
1162331|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
1162332|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
1162333|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
1162334|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
1162335|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
1162336|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
1162338|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
1162339|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
1162340|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
1162341|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
1162342|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
1162343|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
1162344|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
1162345|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
1162346|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
1162347|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
1162348|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
1162349|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
1162350|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
1162351|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
1162352|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
1162353|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
1162354|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
1162355|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
1162356|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
1162357|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
1162358|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
1162359|NCT00405067|E3|Reported Event|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
1162360|NCT00405067|E2|Reported Event|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
1163328|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
1162361|NCT00405067|E1|Reported Event|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
1162362|NCT00406133|B5|Baseline|Total|Total of all reporting groups
1162363|NCT00406133|B4|Baseline|Secondary Cohort Control Group|Participants with baseline A1c <7.0% who were randomized to standard care
1162364|NCT00406133|B3|Baseline|Secondary Cohort RT-CGM Group|Participants with baseline A1c <7.0% who were randomized to CGM use
1162365|NCT00406133|B2|Baseline|Primary Cohort Control Group|Participants with baseline A1c >=7.0% who were randomized to standard care
1162366|NCT00406133|B1|Baseline|Primary Cohort RT-CGM Group|Participants with baseline A1c >=7.0% who were randomized to CGM use
1162367|NCT00406133|P4|Participant Flow|Secondary Cohort Control Group|Participants with baseline A1c <7.0% who were randomized to standard care
1162368|NCT00406133|P3|Participant Flow|Secondary Cohort RT-CGM Group|Participants with baseline A1c <7.0% who were randomized to CGM use
1162369|NCT00406133|P2|Participant Flow|Primary Cohort Control Group|Participants with baseline A1c >=7.0% who were randomized to standard care
1162370|NCT00406133|P1|Participant Flow|Primary Cohort RT-CGM Group|Participants with baseline A1c >=7.0% who were randomized to CGM use
1162371|NCT00406133|O2|Outcome|Control Group|Participants randomized to SMBG
1162372|NCT00406133|O1|Outcome|CGM Group|Participants who were randomized to CGM use
1162373|NCT00406133|O2|Outcome|Control Group|Participants randomized to SMBG
1162374|NCT00406133|O1|Outcome|CGM Group|Participants who were randomized to CGM use
1162375|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
1162376|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
1162377|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
1162378|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
1162379|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
1162380|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
1162381|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
1162382|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
1162383|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
1162384|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
1162385|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HBA1c >=7.0% who were randomized to standard care
1162386|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
1162387|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
1162388|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
1162389|NCT00406133|O2|Outcome|Control Group|Participants randomized to SMBG
1162390|NCT00406133|O1|Outcome|CGM Group|Participants randomized to CGM Use
1162391|NCT00406133|O2|Outcome|Control Group|Participants randomized to SMBG
1162392|NCT00406133|O1|Outcome|CGM Group|Participants who were randomized to CGM use
1162393|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
1162394|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
1162395|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
1162396|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
1162397|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
1162398|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
1162399|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
1162400|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
1162401|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
1162402|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
1162403|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
1162404|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
1162405|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
1162406|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
1162407|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
1162408|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
1162409|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
1162410|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
1162411|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
1162412|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
1163329|NCT00402987|O2|Outcome|Celecoxib 100mg /Placebo|
1162413|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
1162414|NCT00406133|O1|Outcome|Primary Cohort RT-CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
1162415|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
1162416|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
1162417|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
1162418|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
1162419|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
1162420|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
1162421|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
1162422|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
1162423|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
1162424|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
1162425|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
1162426|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
1162427|NCT00406133|E4|Reported Event|Secondary Cohort Control Group|Participants with baseline A1c <7.0% who were randomized to standard care
1162428|NCT00406133|E3|Reported Event|Secondary Cohort RT-CGM Group|Participants with baseline A1c <7.0% who were randomized to CGM use
1162429|NCT00406133|E2|Reported Event|Primary Cohort Control Group|Participants with baseline A1c >=7.0% who were randomized to standard care
1162430|NCT00406133|E1|Reported Event|Primary Cohort RT-CGM Group|Participants with baseline A1c >=7.0% who were randomized to CGM use
1162432|NCT00406107|B2|Baseline|Pegaptanib Sodium 1 mg (Macugen)|Intravitreous injections of Macugen 1.0 mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
1162433|NCT00406107|B1|Baseline|Pegaptanib Sodium 0.3mg (Macugen)|Intravitreous injections of Macugen 0.3mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
1162434|NCT00406107|P2|Participant Flow|Pegaptanib Sodium 1 mg (Macugen)|
1162435|NCT00406107|P1|Participant Flow|Pegaptanib Sodium 0.3mg (Macugen)|
1162436|NCT00406107|O1|Outcome|All Study Participants|Outcome measures were assessed without regard to dosage of pegaptanib received
1162437|NCT00406107|O1|Outcome|All Study Participants|Outcome measures were assessed without regard to dosage of pegaptanib received
1162438|NCT00406107|O2|Outcome|Pegaptanib Sodium 1 mg (Macugen)|Intravitreous injections of Macugen 1.0mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
1162439|NCT00406107|O1|Outcome|Pegaptanib Sodium 0.3mg (Macugen)|Patients experiencing an ocular adverse event, in this case a retinal detachment
1162440|NCT00406107|O1|Outcome|All Study Participants|Outcome measures were assessed without regard to dosage of pegaptanib received
1162441|NCT00406107|O1|Outcome|All Study Participants|Outcome measures were assessed without regard to dosage of pegaptanib received
1162442|NCT00406107|E2|Reported Event|Pegaptanib Sodium 1 mg (Macugen)|Intravitreous injections of Macugen 1.0mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
1162443|NCT00406107|E1|Reported Event|Pegaptanib Sodium 0.3mg (Macugen)|Intravitreous injections of Macugen 0.3mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
1162444|NCT00406029|B6|Baseline|Total|Total of all reporting groups
1162445|NCT00406029|B5|Baseline|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
1162446|NCT00406029|B4|Baseline|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
1162447|NCT00406029|B3|Baseline|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
1162448|NCT00406029|B2|Baseline|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
1162449|NCT00406029|B1|Baseline|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
1162450|NCT00406029|P5|Participant Flow|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
1162451|NCT00406029|P4|Participant Flow|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
1162452|NCT00406029|P3|Participant Flow|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
1162453|NCT00406029|P2|Participant Flow|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
1162454|NCT00406029|P1|Participant Flow|Preladenant 1 mg BID|Participants received preladenant 1 mg twice daily (BID) during the 12-week treatment period.
1162455|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
1162456|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
1162457|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
1162458|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
1162459|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
1162460|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
1162461|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
1162462|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
1162463|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
1162464|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
1162465|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
1162466|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
1162467|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
1162468|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
1162469|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
1162470|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
1162471|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
1162472|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
1162473|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
1162474|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
1162475|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
1162476|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
1162477|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
1162478|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
1163410|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
1162479|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
1162480|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
1162481|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
1162482|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
1162483|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
1162484|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
1162485|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
1162486|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
1162487|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
1162488|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
1162489|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
1162490|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
1162491|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
1162492|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
1162493|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
1162494|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
1162495|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
1162496|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
1162497|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
1162498|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
1162499|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
1162500|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
1162501|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
1162502|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
1162503|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
1162504|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
1162505|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
1162506|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
1162507|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
1162508|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
1162509|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
1162510|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
1163330|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1162511|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
1162512|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
1162513|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
1162514|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
1162515|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
1162516|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
1162517|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
1162518|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
1162519|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
1162520|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
1162521|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
1162522|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
1162523|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
1162524|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
1162525|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
1162526|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
1162527|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
1162528|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
1162529|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
1162530|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
1162531|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
1162532|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
1162533|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
1162534|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
1162535|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
1162536|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
1162537|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
1162538|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
1162539|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
1162540|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
1162541|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
1162542|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
1162543|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
1162544|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
1162545|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
1162546|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
1162547|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
1162548|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
1162549|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
1162550|NCT00406029|E5|Reported Event|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
1162551|NCT00406029|E4|Reported Event|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
1162552|NCT00406029|E3|Reported Event|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
1162553|NCT00406029|E2|Reported Event|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
1162554|NCT00406029|E1|Reported Event|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
1162555|NCT00405964|B3|Baseline|Total|Total of all reporting groups
1162556|NCT00405964|B2|Baseline|Placebo Tablet|Matching placebo, orally daily.
1162557|NCT00405964|B1|Baseline|5-mg Desloratadine Tablet|Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
1162558|NCT00405964|P2|Participant Flow|Placebo Tablet|Matching placebo, orally daily.
1162559|NCT00405964|P1|Participant Flow|5-mg Desloratadine Tablet|Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
1162560|NCT00405964|O2|Outcome|Placebo Tablet|Matching placebo, orally daily.
1162561|NCT00405964|O1|Outcome|5-mg Desloratadine Tablet|Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
1162562|NCT00405964|O2|Outcome|Placebo Tablet|Matching placebo, orally daily.
1162563|NCT00405964|O1|Outcome|5-mg Desloratadine Tablet|Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
1162564|NCT00405964|O2|Outcome|Placebo Tablet|Matching placebo, orally daily.
1162565|NCT00405964|O1|Outcome|5-mg Desloratadine Tablet|Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
1162566|NCT00405964|E2|Reported Event|Placebo Tablet|Matching placebo, orally daily.
1162567|NCT00405964|E1|Reported Event|5-mg Desloratadine Tablet|Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
1162568|NCT00405938|B3|Baseline|Total|Total of all reporting groups
1162569|NCT00405938|B2|Baseline|Bevacizumab/Fulvestrant|Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg intramuscular on Day 1 of Cycle 1, followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg intramuscular of fulvestrant). Treatment will be given in 4-week cycles.
1162570|NCT00405938|B1|Baseline|Bevacizumab/Anastrozole|Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles.
1162571|NCT00405938|P2|Participant Flow|Bevacizumab/Fulvestrant|Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg intramuscular on Day 1 of Cycle 1, followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg intramuscular of fulvestrant). Treatment will be given in 4-week cycles.
1162572|NCT00405938|P1|Participant Flow|Bevacizumab/Anastrozole|Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles.
1162573|NCT00405938|O2|Outcome|Bevacizumab/Fulvestrant|Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg intramuscular on Day 1 of Cycle 1, followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg intramuscular of fulvestrant). Treatment will be given in 4-week cycles.
1162574|NCT00405938|O1|Outcome|Bevacizumab/Anastrozole|Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles.
1162575|NCT00405938|E2|Reported Event|Bevacizumab/Fulvestrant|Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg intramuscular on Day 1 of Cycle 1, followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg intramuscular of fulvestrant). Treatment will be given in 4-week cycles.
1162576|NCT00405938|E1|Reported Event|Bevacizumab/Anastrozole|Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles.
1162577|NCT00405912|B4|Baseline|Total|Total of all reporting groups
1162578|NCT00405912|B3|Baseline|St. John's Wort - 1800 mg /Day|St. John’s Wort was initiated at a dose of 300 mg by mouth three times a day. The dose was increased after the first week to the target doses of 600 mg three times a day. This dose was continued for the next 11 weeks. The medication was stopped at the end of 12 weeks.
1162579|NCT00405912|B2|Baseline|St. John's Wort - 900 mg /Day|St. John's Wort at a dose of 300 mg by mouth three times per day. The medication was stopped at the end of 12 weeks.
1162580|NCT00405912|B1|Baseline|Placebo|The placebo pill was identical in appearance to the active medication. Dosage consisted of 1 pill by mouth three times per day. The medication was stopped at the end of 12 weeks.
1162581|NCT00405912|P3|Participant Flow|St. John's Wort - 1800 mg /Day|St. John’s Wort was initiated at a dose of 300 mg by mouth three times a day. The dose was increased after the first week to the target doses of 600 mg three times a day. This dose was continued for the next 11 weeks. The medication was stopped at the end of 12 weeks.
1162582|NCT00405912|P2|Participant Flow|St. John's Wort - 900 mg /Day|St. John's Wort at a dose of 300 mg by mouth three times per day. The medication was stopped at the end of 12 weeks.
1162583|NCT00405912|P1|Participant Flow|Placebo|The placebo pill was identical in appearance to the active medication. Dosage consisted of 1 pill by mouth three times per day. The medication was stopped at the end of 12 weeks.
1162584|NCT00405912|O3|Outcome|St. John's Wort - 1800 mg /Day|St. John’s Wort was initiated at a dose of 300 mg by mouth three times a day. The dose was increased after the first week to the target doses of 600 mg three times a day. This dose was continued for the next 11 weeks. The medication was stopped at the end of 12 weeks.
1162585|NCT00405912|O2|Outcome|St. John's Wort - 900 mg /Day|St. John's Wort at a dose of 300 mg by mouth three times per day. The medication was stopped at the end of 12 weeks.
1162586|NCT00405912|O1|Outcome|Placebo|The placebo pill was identical in appearance to the active medication. Dosage consisted of 1 pill by mouth three times per day. The medication was stopped at the end of 12 weeks.
1162587|NCT00405912|O3|Outcome|St. John's Wort - 1800 mg /Day|St. John’s Wort was initiated at a dose of 300 mg by mouth three times a day. The dose was increased after the first week to the target doses of 600 mg three times a day. This dose was continued for the next 11 weeks. The medication was stopped at the end of 12 weeks.
1162588|NCT00405912|O2|Outcome|St. John's Wort - 900 mg /Day|St. John's Wort at a dose of 300 mg by mouth three times per day. The medication was stopped at the end of 12 weeks.
1162589|NCT00405912|O1|Outcome|Placebo|The placebo pill was identical in appearance to the active medication. Dosage consisted of 1 pill by mouth three times per day. The medication was stopped at the end of 12 weeks.
1162590|NCT00405912|E3|Reported Event|St. John's Wort - 1800 mg /Day|St. John’s Wort was initiated at a dose of 300 mg by mouth three times a day. The dose was increased after the first week to the target doses of 600 mg three times a day. This dose was continued for the next 11 weeks. The medication was stopped at the end of 12 weeks.
1162591|NCT00405912|E2|Reported Event|St. John's Wort - 900 mg /Day|St. John's Wort at a dose of 300 mg by mouth three times per day. The medication was stopped at the end of 12 weeks.
1162592|NCT00405912|E1|Reported Event|Placebo|The placebo pill was identical in appearance to the active medication. Dosage consisted of 1 pill by mouth three times per day. The medication was stopped at the end of 12 weeks.
1162593|NCT00405821|B3|Baseline|Total|Total of all reporting groups
1162594|NCT00405821|B2|Baseline|Placebo Tablet Twice Daily|
1162595|NCT00405821|B1|Baseline|Acyclovir 400mg Tablet Twice Daily|
1162596|NCT00405821|P2|Participant Flow|Placebo Tablet Twice Daily|
1162597|NCT00405821|P1|Participant Flow|Acyclovir 400mg Tablet Twice Daily|
1162598|NCT00405821|O2|Outcome|Placebo Tablet Twice Daily|
1162599|NCT00405821|O1|Outcome|Acyclovir 400mg Tablet Twice Daily|
1162600|NCT00405821|O2|Outcome|Placebo Tablet Twice Daily|
1162601|NCT00405821|O1|Outcome|Acyclovir 400mg Tablet Twice Daily|
1162602|NCT00405821|O2|Outcome|Placebo Tablet Twice Daily|
1162603|NCT00405821|O1|Outcome|Acyclovir 400mg Tablet Twice Daily|
1162604|NCT00405821|E2|Reported Event|Placebo Tablet Twice Daily|
1162605|NCT00405821|E1|Reported Event|Acyclovir 400mg Tablet Twice Daily|
1162606|NCT00405756|B4|Baseline|Total|Total of all reporting groups
1162607|NCT00405756|B3|Baseline|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1163411|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1162608|NCT00405756|B2|Baseline|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162609|NCT00405756|B1|Baseline|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162610|NCT00405756|P3|Participant Flow|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162611|NCT00405756|P2|Participant Flow|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162612|NCT00405756|P1|Participant Flow|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162613|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162614|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162615|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162616|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162617|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162618|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162619|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162620|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162752|NCT00405548|O1|Outcome|BNP (Nesiritide)|BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
1163331|NCT00402987|O3|Outcome|Placebo|
1162621|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162622|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162623|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162624|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162625|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162626|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162627|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162628|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1163024|NCT00404079|B2|Baseline|Placebo|Placebo was taken daily and orally in capsule forms for 6 months
1162629|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162630|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162631|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162632|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162633|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162634|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162635|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162636|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162637|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162638|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162639|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162640|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162641|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1163332|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
1162642|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162643|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162644|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162645|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162646|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162647|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162648|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162649|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1163025|NCT00404079|B1|Baseline|Glucosamine Sulphate|The glucosamine sulphate (1500 mg) was taken daily and oral in capsule forms for 6 months
1162650|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162651|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162652|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162653|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162654|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162655|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162656|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162657|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162658|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162659|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162660|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162661|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162662|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162663|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162664|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162665|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162666|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162667|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162668|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162669|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162670|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1163026|NCT00404079|P2|Participant Flow|Placebo|Placebo was taken daily and orally in capsule forms for 6 months
1164225|NCT00401401|O4|Outcome|Zalutumumab 16 mg/kg|
1162671|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162672|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162673|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162674|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162675|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162676|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162677|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162678|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162679|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162680|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162681|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162682|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162683|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162684|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162685|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162686|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162687|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162688|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162689|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162690|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162691|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1163027|NCT00404079|P1|Participant Flow|Glucosamine Sulphate|The glucosamine sulphate (1500 mg) was taken daily and oral in capsule forms for 6 months
1162692|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162693|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162694|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162695|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162696|NCT00405756|E3|Reported Event|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162697|NCT00405756|E2|Reported Event|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162698|NCT00405756|E1|Reported Event|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
1162699|NCT00405704|B3|Baseline|Total|Total of all reporting groups
1162700|NCT00405704|B2|Baseline|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
1162701|NCT00405704|B1|Baseline|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
1162702|NCT00405704|P2|Participant Flow|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
1162703|NCT00405704|P1|Participant Flow|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
1162704|NCT00405704|O2|Outcome|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
1162705|NCT00405704|O1|Outcome|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
1162706|NCT00405704|O2|Outcome|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
1162707|NCT00405704|O1|Outcome|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
1162708|NCT00405704|O2|Outcome|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
1162709|NCT00405704|O1|Outcome|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
1162710|NCT00405704|O2|Outcome|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
1162711|NCT00405704|O1|Outcome|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
1162712|NCT00405704|O2|Outcome|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
1162713|NCT00405704|O1|Outcome|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
1162714|NCT00405704|O2|Outcome|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
1162715|NCT00405704|O1|Outcome|Trimethoprim-Sulfamethoxazole|Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
1162716|NCT00405704|O2|Outcome|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
1162717|NCT00405704|O1|Outcome|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
1162718|NCT00405704|O2|Outcome|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
1162719|NCT00405704|O1|Outcome|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
1162720|NCT00405704|E2|Reported Event|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
1162721|NCT00405704|E1|Reported Event|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
1162722|NCT00405652|B1|Baseline|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate sodium (EC-MPS), administered orally twice a day to achieve a dose equimolar to the dose of Mycophenolate mofetil (MMF) the patient was taking at the time of study entry up to a maximum dose of 1440 mg.
1162723|NCT00405652|P1|Participant Flow|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate sodium (EC-MPS), administered orally twice a day to achieve a dose equimolar to the dose of Mycophenolate mofetil (MMF) the patient was taking at the time of study entry up to a maximum dose of 1440 mg.
1162775|NCT00405288|B2|Baseline|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
1162724|NCT00405652|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate sodium (EC-MPS), administered orally twice a day to achieve a dose equimolar to the dose of Mycophenolate mofetil (MMF) the patient was taking at the time of study entry up to a maximum dose of 1440 mg.
1162725|NCT00405652|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate sodium (EC-MPS), administered orally twice a day to achieve a dose equimolar to the dose of Mycophenolate mofetil (MMF) the patient was taking at the time of study entry up to a maximum dose of 1440 mg.
1162726|NCT00405652|E1|Reported Event|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate sodium (EC-MPS), administered orally twice a day to achieve a dose equimolar to the dose of Mycophenolate mofetil (MMF) the patient was taking at the time of study entry up to a maximum dose of 1440 mg.
1162727|NCT00405639|B3|Baseline|Total|Total of all reporting groups
1162728|NCT00405639|B2|Baseline|Placebo|Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
1162729|NCT00405639|B1|Baseline|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
1162730|NCT00405639|P2|Participant Flow|Placebo|Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
1162731|NCT00405639|P1|Participant Flow|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
1162732|NCT00405639|O2|Outcome|Placebo|Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
1162753|NCT00405548|O2|Outcome|Placebo|Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
1162754|NCT00405548|O1|Outcome|BNP (Nesiritide)|BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
1162755|NCT00405548|E2|Reported Event|Placebo|Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
1162733|NCT00405639|O1|Outcome|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
1162734|NCT00405639|O2|Outcome|Placebo|Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
1162735|NCT00405639|O1|Outcome|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
1162736|NCT00405639|O2|Outcome|Placebo|Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
1162737|NCT00405639|O1|Outcome|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
1162776|NCT00405288|B1|Baseline|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
1162738|NCT00405639|O2|Outcome|Placebo|Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
1162739|NCT00405639|O1|Outcome|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
1162740|NCT00405639|E2|Reported Event|Placebo|Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
1162741|NCT00405639|E1|Reported Event|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
1162742|NCT00405548|B3|Baseline|Total|Total of all reporting groups
1162743|NCT00405548|B2|Baseline|Placebo|Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
1162744|NCT00405548|B1|Baseline|BNP (Nesiritide)|BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
1162745|NCT00405548|P2|Participant Flow|Placebo|Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
1162746|NCT00405548|P1|Participant Flow|BNP (Nesiritide)|Brain Natriuretic Peptide (BNP) 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
1162747|NCT00405548|O2|Outcome|Placebo|Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
1162748|NCT00405548|O1|Outcome|BNP (Nesiritide)|BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
1162749|NCT00405548|O2|Outcome|Placebo|Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
1162750|NCT00405548|O1|Outcome|BNP (Nesiritide)|BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
1162751|NCT00405548|O2|Outcome|Placebo|Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
1163333|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1162756|NCT00405548|E1|Reported Event|BNP (Nesiritide)|BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
1162757|NCT00405509|B3|Baseline|Total|Total of all reporting groups
1162758|NCT00405509|B2|Baseline|Unconfirmed Respiratory Infection|participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
1162759|NCT00405509|B1|Baseline|Confirmed Respiratory Infection|participants who had the type of viral infection confirmed by assay
1162760|NCT00405509|P2|Participant Flow|Unconfirmed Respiratory Infection|participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
1162761|NCT00405509|P1|Participant Flow|Confirmed Respiratory Infection|respiratory infection virus type confirmed by assay
1162762|NCT00405509|O2|Outcome|Unconfirmed Respiratory Infection|participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
1162763|NCT00405509|O1|Outcome|Confirmed Respiratory Infection|respiratory infection virus type confirmed by assay
1162764|NCT00405509|O2|Outcome|Unconfirmed Respiratory Infection|participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
1162765|NCT00405509|O1|Outcome|Confirmed Respiratory Infection|respiratory infection virus type confirmed by assay
1162766|NCT00405509|O2|Outcome|Unconfirmed Respiratory Infection|participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
1162767|NCT00405509|O1|Outcome|Confirmed Respiratory Infection|respiratory infection virus type confirmed by assay
1162768|NCT00405509|O2|Outcome|Unconfirmed Respiratory Infection|participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
1162769|NCT00405509|O1|Outcome|Confirmed Respiratory Infection|respiratory infection virus type confirmed by assay
1162770|NCT00405509|O2|Outcome|Unconfirmed Respiratory Infection|participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
1162771|NCT00405509|O1|Outcome|Confirmed Respiratory Infection|respiratory infection virus type confirmed by assay
1162772|NCT00405509|E2|Reported Event|Unconfirmed Respiratory Infection|
1162773|NCT00405509|E1|Reported Event|Confirmed Respiratory Virus|
1162774|NCT00405288|B3|Baseline|Total|Total of all reporting groups
1163028|NCT00404079|O2|Outcome|Glucosamine Sulphate|Glucosamine sulphate was taken daily and orally in capsule forms for 6 months
1162777|NCT00405288|P2|Participant Flow|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
1162778|NCT00405288|P1|Participant Flow|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
1162779|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
1162780|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
1162781|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
1162782|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
1162783|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
1162784|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
1162785|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
1162786|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
1162787|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
1162788|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
1162789|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
1162790|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
1162791|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
1162792|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
1162793|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
1162794|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
1162795|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
1162796|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
1162797|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
1162798|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
1162799|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
1162800|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
1162801|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
1162802|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
1162803|NCT00405288|E2|Reported Event|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
1162804|NCT00405288|E1|Reported Event|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
1162805|NCT00405275|B3|Baseline|Total|Total of all reporting groups
1162806|NCT00405275|B2|Baseline|Etanercept|Etanercept and Methotrexate
1162807|NCT00405275|B1|Baseline|Triple|Hydroxychloroquine, sulfasalazine and methotrexate
1163029|NCT00404079|O1|Outcome|Placebo|Oral intake of placebo capsules
1162808|NCT00405275|P2|Participant Flow|Etanercept|"Etanercept (50mg subcutaneous injections weekly); Methotrexate (maintaining baseline dose, 10-25mg weekly); Placebo, triple: placebo hydroxychloroquine (tablets daily) and placebo sulfasalazine (tablets daily).~Nonresponders (change in DAS28 < 1.2units at 24 weeks) were switched to Triple. This is denoted in results table below as switch. No switch participants remained on Etanercept therapy throughout the trial."
1162809|NCT00405275|P1|Participant Flow|Triple|"Hydroxychloroquine (400mg daily); Sulfasalazine (1g daily for 6 weeks, then increased to 2g daily; Methotrexate (maintaining baseline dose, 10-25mg weekly); Placebo, etanercept (subcutaneous injection).~Nonresponders (change in DAS28 < 1.2units at 24 weeks) were switched to Etanercept at 24 weeks. This is denoted in results table below as switch. No switch participants remained on Triple therapy throughout the trial."
1162810|NCT00405275|O2|Outcome|Etanercept|Etanercept and Methotrexate
1162811|NCT00405275|O1|Outcome|Triple|Hydroxychloroquine, sulfasalazine and methotrexate
1162812|NCT00405275|E2|Reported Event|Etanercept|Etanercept and Methotrexate
1162813|NCT00405275|E1|Reported Event|Triple|Hydroxychloroquine, sulfasalazine and methotrexate
1162814|NCT00404924|B3|Baseline|Total|Total of all reporting groups
1162815|NCT00404924|B2|Baseline|Placebo|Placebo plus best supportive care
1162816|NCT00404924|B1|Baseline|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
1162817|NCT00404924|P2|Participant Flow|Placebo|Placebo plus best supportive care
1162818|NCT00404924|P1|Participant Flow|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
1162819|NCT00404924|O2|Outcome|Placebo|Placebo plus best supportive care
1162820|NCT00404924|O1|Outcome|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
1162821|NCT00404924|O2|Outcome|Placebo|Placebo plus best supportive care
1162822|NCT00404924|O1|Outcome|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
1162823|NCT00404924|O2|Outcome|Placebo|Placebo plus best supportive care
1162824|NCT00404924|O1|Outcome|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
1162825|NCT00404924|O2|Outcome|Placebo|Placebo plus best supportive care
1162826|NCT00404924|O1|Outcome|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
1162827|NCT00404924|O2|Outcome|Placebo|Placebo plus best supportive care
1162828|NCT00404924|O1|Outcome|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
1162829|NCT00404924|O2|Outcome|Placebo|Placebo plus best supportive care
1162830|NCT00404924|O1|Outcome|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
1162831|NCT00404924|E2|Reported Event|Placebo|Placebo
1162832|NCT00404924|E1|Reported Event|Vandetanib|Vandetanib 300 mg
1162833|NCT00404820|B3|Baseline|Total|Total of all reporting groups
1162834|NCT00404820|B2|Baseline|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
1162835|NCT00404820|B1|Baseline|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
1163212|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
1163334|NCT00402987|O4|Outcome|Placebo|
1162836|NCT00404820|P2|Participant Flow|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
1162837|NCT00404820|P1|Participant Flow|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
1162838|NCT00404820|O2|Outcome|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
1162839|NCT00404820|O1|Outcome|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
1162840|NCT00404820|O2|Outcome|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
1162841|NCT00404820|O1|Outcome|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
1163030|NCT00404079|E2|Reported Event|Placebo|Placebo was taken daily and orally in capsule forms for 6 months
1164226|NCT00401401|O3|Outcome|Zalutumumab 12 mg/kg|
1162842|NCT00404820|O2|Outcome|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
1162843|NCT00404820|O1|Outcome|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
1162844|NCT00404820|O2|Outcome|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
1162845|NCT00404820|O1|Outcome|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
1162846|NCT00404820|O2|Outcome|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
1162847|NCT00404820|O1|Outcome|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
1162848|NCT00404820|O2|Outcome|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
1162849|NCT00404820|O1|Outcome|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
1162868|NCT00404651|O3|Outcome|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
1163335|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
1162850|NCT00404820|O2|Outcome|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
1162851|NCT00404820|O1|Outcome|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
1162852|NCT00404820|E2|Reported Event|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
1162853|NCT00404820|E1|Reported Event|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
1162854|NCT00404651|B5|Baseline|Total|Total of all reporting groups
1162855|NCT00404651|B4|Baseline|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
1162856|NCT00404651|B3|Baseline|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
1162857|NCT00404651|B2|Baseline|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
1162858|NCT00404651|B1|Baseline|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
1162859|NCT00404651|P4|Participant Flow|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
1162860|NCT00404651|P3|Participant Flow|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
1162861|NCT00404651|P2|Participant Flow|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
1162862|NCT00404651|P1|Participant Flow|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
1162863|NCT00404651|O4|Outcome|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
1162864|NCT00404651|O3|Outcome|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
1162865|NCT00404651|O2|Outcome|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
1162866|NCT00404651|O1|Outcome|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
1162867|NCT00404651|O4|Outcome|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
1162891|NCT00404547|P1|Participant Flow|Alvesco|320 mcg/day or 640 mcg/day
1162892|NCT00404547|O2|Outcome|Usual Asthma Care and Dosage|as chosen by the Primary Care Physician
1162893|NCT00404547|O1|Outcome|Alvesco|320 mcg/day or 640 mcg/day
1162869|NCT00404651|O2|Outcome|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
1162870|NCT00404651|O1|Outcome|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
1162871|NCT00404651|O4|Outcome|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
1162872|NCT00404651|O3|Outcome|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
1162873|NCT00404651|O2|Outcome|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
1162874|NCT00404651|O1|Outcome|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
1162875|NCT00404651|O4|Outcome|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
1162876|NCT00404651|O3|Outcome|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
1162877|NCT00404651|O2|Outcome|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
1162878|NCT00404651|O1|Outcome|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
1162879|NCT00404651|O4|Outcome|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
1162880|NCT00404651|O3|Outcome|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
1162881|NCT00404651|O2|Outcome|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
1162882|NCT00404651|O1|Outcome|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
1162883|NCT00404651|E4|Reported Event|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
1162884|NCT00404651|E3|Reported Event|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
1162885|NCT00404651|E2|Reported Event|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
1162886|NCT00404651|E1|Reported Event|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
1162887|NCT00404547|B3|Baseline|Total|Total of all reporting groups
1162888|NCT00404547|B2|Baseline|Usual Asthma Care and Dosage|as chosen by the Primary Care Physician
1162889|NCT00404547|B1|Baseline|Alvesco|320 mcg/day or 640 mcg/day
1162890|NCT00404547|P2|Participant Flow|Usual Asthma Care and Dosage|as chosen by the Primary Care Physician
1162899|NCT00404495|B2|Baseline|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
1162900|NCT00404495|B1|Baseline|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
1162901|NCT00404495|P2|Participant Flow|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
1162902|NCT00404495|P1|Participant Flow|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
1162903|NCT00404495|O2|Outcome|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
1162904|NCT00404495|O1|Outcome|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
1162905|NCT00404495|O2|Outcome|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
1162906|NCT00404495|O1|Outcome|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
1162907|NCT00404495|O2|Outcome|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
1162908|NCT00404495|O1|Outcome|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
1162909|NCT00404495|O2|Outcome|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
1162910|NCT00404495|O1|Outcome|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
1162911|NCT00404495|O2|Outcome|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
1162912|NCT00404495|O1|Outcome|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
1162913|NCT00404495|O2|Outcome|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
1162914|NCT00404495|O1|Outcome|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
1162915|NCT00404495|E2|Reported Event|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
1162916|NCT00404495|E1|Reported Event|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
1162917|NCT00404352|B4|Baseline|Total|Total of all reporting groups
1162918|NCT00404352|B3|Baseline|Placebo (DB Population)|Single dose of matching placebo administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
1162919|NCT00404352|B2|Baseline|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
1162920|NCT00404352|B1|Baseline|RNF 44 Mcg Three Times Weekly (Double Blind [DB] Population)|Single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of interferon [IFN]-beta-1a (RNF) injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
1163336|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
1162921|NCT00404352|P9|Participant Flow|Placebo/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received placebo in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
1162922|NCT00404352|P8|Participant Flow|RNF 44 Mcg Once Weekly/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received RNF once weekly in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
1162923|NCT00404352|P7|Participant Flow|RNF 44Mcg Three Times Weekly/RNF 44Mcg Three Times Weekly(OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year open label extension (OLE). Participants who had received RNF three times a week in the core REFLEX trial, were re-titrated with a single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
1162924|NCT00404352|P6|Participant Flow|Placebo/OL RNF 44 Mcg Three Times Weekly|After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months.
1162925|NCT00404352|P5|Participant Flow|RNF 44 Mcg Once Weekly/OL RNF 44 Mcg Three Times Weekly|After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months.
1163031|NCT00404079|E1|Reported Event|Glucosamine Sulphate|The glucosamine sulphate (1500 mg) was taken daily and oral in capsule forms for 6 months
1163241|NCT00403234|O4|Outcome|BTDS 30|Buprenorphine transdermal patch 10 + 20 mcg/h applied for 7-day wear
1164227|NCT00401401|O2|Outcome|Zalutumumab 8 mg/kg|
1162926|NCT00404352|P4|Participant Flow|RNF 44 Mcg Three Times Weekly/OL RNF 44 Mcg Three Times Weekly|After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months.
1162927|NCT00404352|P3|Participant Flow|Placebo (DB Population)|Single dose of matching placebo administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
1162928|NCT00404352|P2|Participant Flow|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
1162929|NCT00404352|P1|Participant Flow|RNF 44 Mcg Three Times Weekly (Double Blind [DB] Population)|Single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of interferon [IFN]-beta-1a (RNF) injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
1162930|NCT00404352|O3|Outcome|Placebo/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received placebo in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
1162931|NCT00404352|O2|Outcome|RNF 44 Mcg Once Weekly/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received RNF once weekly in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
1162932|NCT00404352|O1|Outcome|RNF 44Mcg Three Times Weekly/RNF 44Mcg Three Times Weekly(OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year open label extension (OLE). Participants who had received RNF three times a week in the core REFLEX trial, were re-titrated with a single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
1162933|NCT00404352|O3|Outcome|Placebo/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received placebo in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
1162934|NCT00404352|O2|Outcome|RNF 44 Mcg Once Weekly/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received RNF once weekly in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
1162949|NCT00404352|O2|Outcome|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
1162935|NCT00404352|O1|Outcome|RNF 44Mcg Three Times Weekly/RNF 44Mcg Three Times Weekly(OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year open label extension (OLE). Participants who had received RNF three times a week in the core REFLEX trial, were re-titrated with a single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
1162936|NCT00404352|O3|Outcome|Placebo/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received placebo in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
1162937|NCT00404352|O2|Outcome|RNF 44 Mcg Once Weekly/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received RNF once weekly in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
1162938|NCT00404352|O1|Outcome|RNF 44Mcg Three Times Weekly/RNF 44Mcg Three Times Weekly(OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year open label extension (OLE). Participants who had received RNF three times a week in the core REFLEX trial, were re-titrated with a single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
1162939|NCT00404352|O3|Outcome|Placebo/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received placebo in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
1162955|NCT00404352|E5|Reported Event|RNF 44 Mcg Once Weekly/OL RNF 44 Mcg Three Times Weekly|After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months.
1164228|NCT00401401|O1|Outcome|Zalutumumab 4 mg/kg|
1162940|NCT00404352|O2|Outcome|RNF 44 Mcg Once Weekly/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received RNF once weekly in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
1162941|NCT00404352|O1|Outcome|RNF 44Mcg Three Times Weekly/RNF 44Mcg Three Times Weekly(OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year open label extension (OLE). Participants who had received RNF three times a week in the core REFLEX trial, were re-titrated with a single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
1162942|NCT00404352|O3|Outcome|Placebo/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received placebo in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
1162943|NCT00404352|O2|Outcome|RNF 44 Mcg Once Weekly/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received RNF once weekly in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
1162944|NCT00404352|O1|Outcome|RNF 44Mcg Three Times Weekly/RNF 44Mcg Three Times Weekly(OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year open label extension (OLE). Participants who had received RNF three times a week in the core REFLEX trial, were re-titrated with a single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
1162945|NCT00404352|O3|Outcome|Placebo (DB Population)|Single dose of matching placebo administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
1162946|NCT00404352|O2|Outcome|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
1162947|NCT00404352|O1|Outcome|RNF 44 Mcg Three Times Weekly (Double Blind [DB] Population)|Single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of interferon [IFN]-beta-1a (RNF) injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
1162948|NCT00404352|O3|Outcome|Placebo (DB Population)|Single dose of matching placebo administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
1162950|NCT00404352|O1|Outcome|RNF 44 Mcg Three Times Weekly (Double Blind [DB] Population)|Single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of interferon [IFN]-beta-1a (RNF) injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
1162951|NCT00404352|E9|Reported Event|Placebo/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received placebo in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
1162952|NCT00404352|E8|Reported Event|RNF 44 Mcg Once Weekly/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received RNF once weekly in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
1162953|NCT00404352|E7|Reported Event|RNF 44Mcg Three Times Weekly/RNF 44Mcg Three Times Weekly(OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year open label extension (OLE). Participants who had received RNF three times a week in the core REFLEX trial, were re-titrated with a single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
1162954|NCT00404352|E6|Reported Event|Placebo/OL RNF 44 Mcg Three Times Weekly|After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months.
1163014|NCT00404092|O1|Outcome|1st Cohort|"70mg 1x/day~caspofungin : i.v."
1163015|NCT00404092|O4|Outcome|4th Cohort|"200mg 1x/day~caspofungin : i.v."
1163016|NCT00404092|O3|Outcome|3rd Cohort|"150mg 1x/day~caspofungin : i.v."
1162956|NCT00404352|E4|Reported Event|RNF 44 Mcg Three Times Weekly/OL RNF 44 Mcg Three Times Weekly|After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months.
1162957|NCT00404352|E3|Reported Event|Placebo (DB Population)|Single dose of matching placebo administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
1162958|NCT00404352|E2|Reported Event|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
1162959|NCT00404352|E1|Reported Event|RNF 44 Mcg Three Times Weekly (Double Blind [DB] Population)|Single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of interferon [IFN]-beta-1a (RNF) injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
1162960|NCT00404248|B4|Baseline|Total|Total of all reporting groups
1162961|NCT00404248|B3|Baseline|Arm 3 no Stratification (+EIASD or -EIASD)|"Subjects were not stratified by antiseizure drugs~Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Only dose tested: 2200.~NO intrasubject dose escalation.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
1162962|NCT00404248|B2|Baseline|Arm 2 -EIASD|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
1162963|NCT00404248|B1|Baseline|Arm 1 +EIASD|"subjects on the +EIASD treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
1162964|NCT00404248|P9|Participant Flow|Arm 9 - Non Stratified (Both +EIASD and -EIASD)|"Subjects in this group were not stratified based on anti-sezuire medication..~Subjects will take terameprocol for 5 consecutive days each month by IV. This was for dose 2200mg/day. New formulation TC6."
1162965|NCT00404248|P8|Participant Flow|Arm 8 -EIASD Level 4|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 4 = 2200mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion"
1162966|NCT00404248|P7|Participant Flow|Arm 7 -EIASD Level 3|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 3 = 1700mg/day. NO intrasubject dose escalation. this Arm including pts treated at the new formulation TC6 at 1700mg~PK data will be collected on day one of cycle one infusion"
1163060|NCT00403767|P2|Participant Flow|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
1166749|NCT00395044|O1|Outcome|Gabapentin|1200 mg/daily of Gabapentin
1162967|NCT00404248|P6|Participant Flow|Arm 6 -EIASD Level 2|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 2 = 1100mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion"
1162968|NCT00404248|P5|Participant Flow|Arm 5 Non-Enzyme Inducing Antiseizure Drug (-EIASD) Level 1|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 1 = 750mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion"
1162969|NCT00404248|P4|Participant Flow|Arm 4 +EIASD Level 4|"subjects on the +EIASD (Level 4) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 4= 2220mg/day. NO intrasubject dose escalation."
1162970|NCT00404248|P3|Participant Flow|Arm 3 +EIASD Level 3|"subjects on the +EIASD (Level 3) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 3= 1700mg/day. NO intrasubject dose escalation. Includes pts at the new formulation TC6 at 1700mg"
1162971|NCT00404248|P2|Participant Flow|Arm 2 +EIASD Level 2|"subjects on the +EIASD (Level 2) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 2= 1100mg/day. NO intrasubject dose escalation."
1162972|NCT00404248|P1|Participant Flow|Arm 1 Enzyme Inducing Antiseizure Drug (+ EIASD) Level 1|"subjects on the +EIASD (Level 1) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 1= 750mg/day. NO intrasubject dose escalation.~Pharmacokinetics (PK) data will be collected on day one of cycle one infusion"
1163017|NCT00404092|O2|Outcome|2nd Cohort|"100mg 1x/day~caspofungin : i.v."
1163018|NCT00404092|O1|Outcome|1st Cohort|"70mg 1x/day~caspofungin : i.v."
1163019|NCT00404092|E4|Reported Event|4th Cohort|"200mg 1x/day~caspofungin : i.v."
1163020|NCT00404092|E3|Reported Event|3rd Cohort|"150mg 1x/day~caspofungin : i.v."
1162973|NCT00404248|O1|Outcome|Phase 1 Terameprocol|"subjects were either on the +EIASD antiseizure durgs: (phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine). or not on antiseizure drugs - or those effecting hepatic enzymes ( -EIASD) such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagavine, topiramate, zonisamide and felbamate.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
1162974|NCT00404248|O1|Outcome|Phase 1 Terameprocol|"subjects were either on the +EIASD antiseizure durgs: (phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine). or not on antiseizure drugs - or those effecting hepatic enzymes ( -EIASD) such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagavine, topiramate, zonisamide and felbamate.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
1162975|NCT00404248|O2|Outcome|Arm 2 -EIASD|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
1162976|NCT00404248|O1|Outcome|Arm 1 +EIASD|"subjects on the +EIASD treatment arm were taking one of these antiseizure durgs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
1162977|NCT00404248|O2|Outcome|Arm 2 -EIASD|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
1162978|NCT00404248|O1|Outcome|Arm 1 +EIASD|"subjects on the +EIASD treatment arm were taking one of these antiseizure durgs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
1162979|NCT00404248|O2|Outcome|Arm 2 -EIASD|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
1162980|NCT00404248|O1|Outcome|Arm 1 +EIASD|"subjects on the +EIASD treatment arm were taking one of these antiseizure durgs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
1162981|NCT00404248|O9|Outcome|Non Stratified (Both +EIASD and -EIASD)|"Subjects in this group were not stratified based on anti-sezuire medication..~Subjects will take terameprocol for 5 consecutive days each month by IV. This was for dose 2200mg/day.~New formulation TC6 - NONPEG or -PEG. (polyethylene glycol )"
1163061|NCT00403767|P1|Participant Flow|Rivaroxaban|Rivaroxaban 15 mg p.o. once daily or Rivaroxaban 20 mg p.o. once daily
1162982|NCT00404248|O8|Outcome|-EIASD Level 4 (2200 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 4 = 2200mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
1162983|NCT00404248|O7|Outcome|-EIASD Level 3 (1700 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 3 = 1700mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation and new TC6 -PEG Formulation - Pts treated from both formulations"
1162984|NCT00404248|O6|Outcome|-EIASD Level 2 (1100 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 2 = 1100mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
1162985|NCT00404248|O5|Outcome|-EIASD Level 1 (750 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 1 = 750mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
1162986|NCT00404248|O4|Outcome|+EIASD Level 4 (2200 mg/dayx5D)|"subjects on the +EIASD (Level 4) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 4= 2220mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
1162987|NCT00404248|O3|Outcome|+EIASD Level 3 (1700 mg/dayx5D)|"subjects on the +EIASD (Level 3) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 3= 1700mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation; Includes patientss at the new formulation TC6 (-PEG)"
1163021|NCT00404092|E2|Reported Event|2nd Cohort|"100mg 1x/day~caspofungin : i.v."
1162988|NCT00404248|O2|Outcome|+EIASD Level 2 (1100 mg/dayx5D)|"subjects on the +EIASD (Level 2) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 2= 1100mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
1162989|NCT00404248|O1|Outcome|+ EIASD Level 1 (750 mg/dayx5D)|"subjects on the +EIASD (Level 1) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 1= 750mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
1162990|NCT00404248|O3|Outcome|ARM 3 (No Stratification)|"Subjects in this group were not stratified based on anti-sezuire medication..~Subjects will take terameprocol for 5 consecutive days each month by IV. This was for dose 2200mg/day.~New formulation TC6."
1162991|NCT00404248|O2|Outcome|ARM 2 -EIASD (Enzyme-inducing Antizeizure Drug)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Various Dose levels 1= 750mg/dayx5; 2=1100mg/dayx5; 3=1700mg/dayx5; 4=2200mg/dayx5~NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion"
1162992|NCT00404248|O1|Outcome|Arm 1 +EIASD (Enzyme-inducing Antizeizure Drug)|"subjects on the +EIASD (Level 1) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Various Dose levels 1= 750mg/dayx5; 2=1100mg/dayx5; 3=1700mg/dayx5; 4=2200mg/dayx5~NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion"
1162993|NCT00404248|E9|Reported Event|Non Stratified (Both +EIASD and -EIASD)|"Subjects in this group were not stratified based on anti-seizure medication..~Subjects will take terameprocol for 5 consecutive days each month by IV. This was for dose 2200mg/day.~New formulation TC6 - NONPEG or -PEG."
1162994|NCT00404248|E8|Reported Event|-EIASD Level 4 (2200 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hypatic enzynmes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagavine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 4 = 2200mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
1162995|NCT00404248|E7|Reported Event|-EIASD Level 3 (1700 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hypatic enzynmes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagavine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 3 = 1700mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion"
1162996|NCT00404248|E6|Reported Event|-EIASD Level 2 (1100 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hypatic enzynmes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagavine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 2 = 1100mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
1163062|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
1163063|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
1162997|NCT00404248|E5|Reported Event|-EIASD Level 1 (750 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hypatic enzynmes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagavine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 1 = 750mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
1162998|NCT00404248|E4|Reported Event|+EIASD Level 4 (2200 mg/dayx5D)|"subjects on the +EIASD (Level 4) treatment arm were taking one of these antiseizure durgs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 4= 2220mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
1162999|NCT00404248|E3|Reported Event|+EIASD Level 3 (1700 mg/dayx5D)|"subjects on the +EIASD (Level 3) treatment arm were taking one of these antiseizure durgs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 3= 1700mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation; Includes pts at the new formulation TC6 (-PEG)"
1163000|NCT00404248|E2|Reported Event|+EIASD Level 2 (1100 mg/dayx5D)|"subjects on the +EIASD (Level 2) treatment arm were taking one of these antiseizure durgs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 2= 1100mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
1163001|NCT00404248|E1|Reported Event|+ EIASD Level 1 (750 mg/dayx5D)|"subjects on the +EIASD (Level 1) treatment arm were taking one of these antiseizure durgs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 1= 750mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
1163002|NCT00404092|B5|Baseline|Total|Total of all reporting groups
1163003|NCT00404092|B4|Baseline|4th Cohort|"200mg 1x/day~caspofungin : i.v."
1163004|NCT00404092|B3|Baseline|3rd Cohort|"150mg 1x/day~caspofungin : i.v."
1163005|NCT00404092|B2|Baseline|2nd Cohort|"100mg 1x/day~caspofungin : i.v."
1163006|NCT00404092|B1|Baseline|1st Cohort|"70mg 1x/day~caspofungin : i.v."
1163007|NCT00404092|P4|Participant Flow|4th Cohort|"200mg 1x/day~caspofungin : i.v."
1163008|NCT00404092|P3|Participant Flow|3rd Cohort|"150mg 1x/day~caspofungin : i.v."
1163009|NCT00404092|P2|Participant Flow|2nd Cohort|"100mg 1x/day~caspofungin : i.v."
1163010|NCT00404092|P1|Participant Flow|1st Cohort|"70mg 1x/day~caspofungin : i.v."
1163011|NCT00404092|O4|Outcome|4th Cohort|"200mg 1x/day~caspofungin : i.v."
1163012|NCT00404092|O3|Outcome|3rd Cohort|"150mg 1x/day~caspofungin : i.v."
1163013|NCT00404092|O2|Outcome|2nd Cohort|"100mg 1x/day~caspofungin : i.v."
1163032|NCT00403845|B1|Baseline|Entire Study Population|The entire study population included all 4 treatment groups who received indacaterol 150 µg, 300 µg, and 600 µg and placebo via a single dose dry powder inhaler (SDDPI) in 4 different sequences. Two capsules of study medication were inhaled in the morning between 8:00 and 10:00 am on Day 1 of each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
1163033|NCT00403845|P4|Participant Flow|Indacaterol 600μg-indacaterol 300μg-indacaterol 150μg-placebo|In treatment period 1, patients received 2 indacaterol 300 μg capsules; in treatment period 2, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; in treatment period 3, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; and in treatment period 4 patients received 2 placebo capsules. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
1163034|NCT00403845|P3|Participant Flow|Indacaterol 300μg-placebo-indacaterol 600μg-indacaterol 150μg|In treatment period 1, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; in treatment period 2, patients received 2 placebo capsules; in treatment period 3, patients received 2 indacaterol 300 μg capsules; and in treatment period 4, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
1163035|NCT00403845|P2|Participant Flow|Indacaterol 150μg-indacaterol 600μg-placebo-indacaterol 300μg|In treatment period 1, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; in treatment period 2, patients received 2 indacaterol 300 μg capsules; in treatment period 3, patients received 2 placebo capsules; and in treatment period 4, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
1163036|NCT00403845|P1|Participant Flow|Placebo-indacaterol 150μg-indacaterol 300μg-indacaterol 600μg|In treatment period, 1 patients received 2 placebo capsules; in treatment period 2, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; in treatment period 3, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; and in treatment period 4, patients received 2 indacaterol 300 μg capsules. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
1163037|NCT00403845|O4|Outcome|Placebo|Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Placebo was administered to each patient only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
1163038|NCT00403845|O3|Outcome|Indacaterol 150 µg|One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
1163064|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
1163065|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
1163039|NCT00403845|O2|Outcome|Indacaterol 300 µg|One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
1163040|NCT00403845|O1|Outcome|Indacaterol 600 μg|Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
1163041|NCT00403845|O4|Outcome|Placebo|Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Placebo was administered to each patient only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
1163042|NCT00403845|O3|Outcome|Indacaterol 150 µg|One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
1163043|NCT00403845|O2|Outcome|Indacaterol 300 µg|One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
1163044|NCT00403845|O1|Outcome|Indacaterol 600 μg|Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
1163045|NCT00403845|O4|Outcome|Placebo|Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Placebo was administered to each patient only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
1163046|NCT00403845|O3|Outcome|Indacaterol 150 µg|One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
1163047|NCT00403845|O2|Outcome|Indacaterol 300 µg|One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
1163083|NCT00403767|E1|Reported Event|Rivaroxaban|Rivaroxaban 15 mg p.o. once daily or Rivaroxaban 20 mg p.o. once daily
1163242|NCT00403234|O3|Outcome|BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
1163048|NCT00403845|O1|Outcome|Indacaterol 600 μg|Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
1163049|NCT00403845|O4|Outcome|Placebo|Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Placebo was administered to each patient only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
1163050|NCT00403845|O3|Outcome|Indacaterol 150 µg|One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
1163051|NCT00403845|O2|Outcome|Indacaterol 300 µg|One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
1163052|NCT00403845|O1|Outcome|Indacaterol 600 μg|Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
1163053|NCT00403845|E4|Reported Event|Indacaterol 600 μg|Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
1163054|NCT00403845|E3|Reported Event|Indacaterol 300 μg|One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
1163055|NCT00403845|E2|Reported Event|Indacaterol 150 μg|One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
1163056|NCT00403845|E1|Reported Event|Placebo|Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Placebo was administered to each patient only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
1163057|NCT00403767|B3|Baseline|Total|Total of all reporting groups
1163058|NCT00403767|B2|Baseline|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
1163059|NCT00403767|B1|Baseline|Rivaroxaban|Rivaroxaban 15 mg p.o. once daily or Rivaroxaban 20 mg p.o. once daily
1163067|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
1163068|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
1163069|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
1163070|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
1163071|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
1163072|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
1163073|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
1163074|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
1163075|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
1163076|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
1163077|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
1163078|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
1163079|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
1163080|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
1163081|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
1163082|NCT00403767|E2|Reported Event|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
1163243|NCT00403234|O2|Outcome|BTDS 10|Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
1163084|NCT00403754|B1|Baseline|Entire Study Population|"The entire study population included all 4 treatment groups who received indacaterol 150 µg, 300 µg, and 600 µg and placebo via a single dose dry powder inhaler (SDDPI) in the 4 different sequences of the core phase. Two capsules of study medication were inhaled in the morning on Day 1 of each treatment period. Following the core phase patients continued to the Salmeterol open label phase. Salmeterol was inhaled via a Diskus inhalation device 50 µg in the morning and 50 µg 12 hours post initial dose on Day 1. Patients received each treatment only once.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
1163085|NCT00403754|P4|Participant Flow|Ind 600 μg-Ind 300 μg-Ind150 μg-Placebo-Salmeterol|"In treatment period 1: patients received 2 indacaterol (Ind) 300 μg capsules; in treatment period 2: patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; in treatment period 3: patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; and in treatment period 4: patients received 2 placebo capsules. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use t"
1163086|NCT00403754|P3|Participant Flow|Ind 300 μg-Placebo-Ind 600 μg-Ind 150 μg-Salmeterol|"In treatment period 1: patients received 1 indacaterol (Ind) 300 μg capsule + 1 placebo capsule; in treatment period 2: patients received 2 placebo capsules; in treatment period 3: patients received 2 indacaterol 300 μg capsules; and in treatment period 4: patients received 1 indacaterol 150 μg capsule + 1 placebo capsule. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation, device on Day 1.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use t"
1163087|NCT00403754|P2|Participant Flow|Ind 150 μg-Ind 600 μg-Placebo-Ind 300 μg-Salmeterol|"In treatment period 1: patients received 1 indacaterol (Ind) 150 μg capsule + 1 placebo capsule; in treatment period 2: patients received 2 indacaterol 300 μg capsules; in treatment period 3: patients received 2 placebo capsules; and in treatment period 4: patients received 1 indacaterol 300 μg capsule + 1 placebo capsule. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
1163102|NCT00403754|O2|Outcome|Indacaterol 300 µg|"One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
1163213|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
1163214|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
1163088|NCT00403754|P1|Participant Flow|Placebo-Ind 150 μg-Ind 300 μg-Ind 600 μg-Salmeterol|"In treatment period 1: patients received 2 placebo capsules; in treatment period 2: patients received 1 indacaterol (Ind) 150 μg capsule + 1 placebo capsule; in treatment period 3: patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; and in treatment period 4: patients received 2 indacaterol 300 μg capsules. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
1163089|NCT00403754|O5|Outcome|Salmeterol 100 μg|"Open label Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
1163090|NCT00403754|O4|Outcome|Placebo|"Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Placebo was administered to each patient only once.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
1163091|NCT00403754|O3|Outcome|Indacaterol 150 µg|"One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
1163092|NCT00403754|O2|Outcome|Indacaterol 300 µg|"One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
1163093|NCT00403754|O1|Outcome|Indacaterol 600 µg|"Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
1163230|NCT00403273|E2|Reported Event|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
1163244|NCT00403234|O1|Outcome|Placebo|Placebo transdermal patch applied for 7-day wear
1163094|NCT00403754|O5|Outcome|Salmeterol 100 μg|"Open label Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
1163095|NCT00403754|O4|Outcome|Placebo|"Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Placebo was administered to each patient only once.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
1163096|NCT00403754|O3|Outcome|Indacaterol 150 µg|"One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
1163097|NCT00403754|O2|Outcome|Indacaterol 300 µg|"One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
1163098|NCT00403754|O1|Outcome|Indacaterol 600 µg|"Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
1163099|NCT00403754|O5|Outcome|Salmeterol 100 μg|"Open label Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
1163100|NCT00403754|O4|Outcome|Placebo|"Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Placebo was administered to each patient only once.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
1163101|NCT00403754|O3|Outcome|Indacaterol 150 µg|"One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
1163215|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
1163103|NCT00403754|O1|Outcome|Indacaterol 600 µg|"Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
1163104|NCT00403754|O5|Outcome|Salmeterol 100 μg|"Open label Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
1163105|NCT00403754|O4|Outcome|Placebo|"Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Placebo was administered to each patient only once.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
1163106|NCT00403754|O3|Outcome|Indacaterol 150 µg|"One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
1163107|NCT00403754|O2|Outcome|Indacaterol 300 µg|"One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
1163108|NCT00403754|O1|Outcome|Indacaterol 600 µg|"Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
1163109|NCT00403754|E5|Reported Event|Salmeterol 100 μg|Open label Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
1163337|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1163110|NCT00403754|E4|Reported Event|Placebo|"2 Placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of the Placebo treatment period.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
1163111|NCT00403754|E3|Reported Event|Indacaterol 600 μg|"2 Indacaterol 300 μg capsules were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of the Indacaterol 600 μg treatment period.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
1163112|NCT00403754|E2|Reported Event|Indacaterol 300 μg|"1 Indacaterol 300 μg capsules + 1 Placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of the Indacaterol 300 μg treatment period.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
1163113|NCT00403754|E1|Reported Event|Indacaterol 150 μg|"1 Indacaterol 150 μg capsule + 1 Placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of the Indacaterol 150 μg treatment period.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
1163114|NCT00403585|B1|Baseline|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
1163115|NCT00403585|P1|Participant Flow|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
1163116|NCT00403585|O1|Outcome|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
1163117|NCT00403585|O1|Outcome|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
1163118|NCT00403585|O1|Outcome|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
1163119|NCT00403585|O1|Outcome|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
1163120|NCT00403585|O1|Outcome|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
1163121|NCT00403585|O1|Outcome|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
1163122|NCT00403585|E1|Reported Event|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
1163123|NCT00403546|B3|Baseline|Total|Total of all reporting groups
1163124|NCT00403546|B2|Baseline|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
1163125|NCT00403546|B1|Baseline|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
1163207|NCT00403273|P1|Participant Flow|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
1163208|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
1163126|NCT00403546|P3|Participant Flow|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
1163127|NCT00403546|P2|Participant Flow|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
1163128|NCT00403546|P1|Participant Flow|Standard Treatment Ziprasidone|Upon signing informed consent participants with schizophrenia or schizoaffective disorder, who were not yet taking ziprasidone could initiate open-label standard treatment ziprasidone (160 milligrams per day [160 mg/d]: 80 mg twice daily) for a minimum of 3 weeks to be eligible for screening to enter the randomized trial. Participants who were already taking standard treatment ziprasidone for 3 weeks or longer at time of enrollment were eligible for screening, as well.
1163129|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
1163130|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
1163131|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
1163132|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
1163231|NCT00403273|E1|Reported Event|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
1163232|NCT00403234|B5|Baseline|Total|Total of all reporting groups
1163338|NCT00402987|O3|Outcome|Placebo|
1163133|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
1163134|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
1163135|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
1163136|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
1163137|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
1163138|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
1163139|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
1163140|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
1163141|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
1163142|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
1163143|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
1163144|NCT00403546|O1|Outcome|High Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
1163145|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
1163146|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
1163147|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
1163233|NCT00403234|B4|Baseline|BTDS 30|Buprenorphine transdermal patch 10 + 20 mcg/h applied for 7-day wear
1163234|NCT00403234|B3|Baseline|BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
1163235|NCT00403234|B2|Baseline|BTDS 10|Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
1163148|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
1163149|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
1163150|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
1163151|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
1163152|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
1163153|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
1163154|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
1163155|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
1163156|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
1163157|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
1163158|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
1163159|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
1163160|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
1163161|NCT00403546|O2|Outcome|Placebo, Standard Treatment Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
1163162|NCT00403546|O1|Outcome|High-Dose Ziprasidone|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
1163236|NCT00403234|B1|Baseline|Placebo|Placebo transdermal patch applied for 7-day wear
1163237|NCT00403234|P4|Participant Flow|BTDS 30|Buprenorphine transdermal patch 10 + 20 mcg/h applied for 7-day wear
1163238|NCT00403234|P3|Participant Flow|BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
1163339|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
1163163|NCT00403546|E4|Reported Event|Placebo, Standard Treatment Ziprasidone Randomized Trial|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take matching placebo oral capsule twice daily added to their regular open-label ziprasidone dose of 160 mg/d. After the first week, the matching placebo was increased to two capsules twice daily and their regular open-label ziprasidone remained the same (160 mg/d) for 7 weeks.
1163164|NCT00403546|E3|Reported Event|High-Dose Ziprasidone Randomized Trial|Participants with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with ziprasidone 160 mg/d for at least 3 weeks were instructed to take ziprasidone oral capsule twice daily added to their regular open-label ziprasidone dose (total of 240 mg/d). After the first week, the study drug was increased to a total ziprasidone dose of 320 mg/d for 7 weeks.
1163165|NCT00403546|E2|Reported Event|Standard Treatment Ziprasidone Screening Phase|Participants who had taken standard treatment ziprasidone for 3 weeks or longer were eligible for screening to enter the randomized trial.
1163166|NCT00403546|E1|Reported Event|Standard Treatment Ziprasidone Open-label Phase|Upon signing informed consent participants with schizophrenia or schizoaffective disorder, who were not yet taking ziprasidone could initiate open-label standard treatment ziprasidone (160 milligrams per day [160 mg/d]: 80 mg twice daily) for a minimum of 3 weeks to be eligible for screening to enter the randomized trial.
1163167|NCT00403481|B1|Baseline|Active Treatmant Arm|All participants started this arm with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled.
1163168|NCT00403481|P1|Participant Flow|Active Treatment Period|All participants started this arm with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled.
1163169|NCT00403481|O1|Outcome|Overall Study Population|
1163170|NCT00403481|O1|Outcome|Overall Study Population|
1163171|NCT00403481|O1|Outcome|Overall Study Population|
1163172|NCT00403481|O1|Outcome|Overall Study Population|
1163173|NCT00403481|O1|Outcome|Overall Study Population|
1163174|NCT00403481|O1|Outcome|Overall Study Population|
1163175|NCT00403481|O1|Outcome|Overall Study Population|
1163176|NCT00403481|O1|Outcome|Overall Study Population|
1163177|NCT00403481|O1|Outcome|Overall Study Population|
1163209|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
1163210|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
1163178|NCT00403481|E4|Reported Event|Olmesartan 40 mg and Hydrochlorothiazide 25 mg|All participants started with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled
1163179|NCT00403481|E3|Reported Event|Olmesartan 40 mg and Hydrochlorothiazide 12.5 mg|All participants started with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled
1163180|NCT00403481|E2|Reported Event|Olmesartan 40 mg|All participants started with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled
1163181|NCT00403481|E1|Reported Event|Olmesartan 20 mg|All participants started with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled.
1163182|NCT00403455|B1|Baseline|Paroxetine Arm|This is a single arm, single site, open-label clinical trial to treat veterans with PTSD. It is a 12-week trial to investigate the efficacy of paroxetine in reducing PTSD symptoms, with the primary outcome measure using CAPS. Genetic information is included to understand why some respond and some do not respond to paroxetine treatment. Both male and female combat veterans ages 18 years and older who meet DSM-III-R criteria for principle diagnosis of PTSD as determined by the CAP-S were recruited for this study.
1163183|NCT00403455|P1|Participant Flow|Paroxetine Arm|This is a single arm, single site, open-label clinical trial to treat veterans with PTSD. It is a 12-week trial to investigate the efficacy of paroxetine in reducing PTSD symptoms, with the primary outcome measure using CAPS. Genetic information is included to understand why some respond and some do not respond to paroxetine treatment. Both male and female combat veterans ages 18 years and older who meet DSM-III-R criteria for principle diagnosis of PTSD as determined by the CAP-S were recruited for this study.
1163184|NCT00403455|O1|Outcome|Paroxetine Arm|This is a single arm, single site, open-label clinical trial to treat veterans with PTSD. It is a 12-week trial to investigate the efficacy of paroxetine in reducing PTSD symptoms, with the primary outcome measure using CAPS. Genetic information is included to understand why some respond and some do not respond to paroxetine treatment.
1163185|NCT00403455|E1|Reported Event|Paroxetine Arm|This is a single arm, single site, open-label clinical trial to treat veterans with PTSD. It is a 12-week trial to investigate the efficacy of paroxetine in reducing PTSD symptoms, with the primary outcome measure using CAPS. Genetic information is included to understand why some respond and some do not respond to paroxetine treatment.
1163186|NCT00403403|B3|Baseline|Total|Total of all reporting groups
1163239|NCT00403234|P2|Participant Flow|BTDS 10|Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
1163187|NCT00403403|B2|Baseline|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
1163188|NCT00403403|B1|Baseline|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
1163189|NCT00403403|P2|Participant Flow|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
1163190|NCT00403403|P1|Participant Flow|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
1163191|NCT00403403|O2|Outcome|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
1163211|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
1163192|NCT00403403|O1|Outcome|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
1163193|NCT00403403|O2|Outcome|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
1163194|NCT00403403|O1|Outcome|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
1163195|NCT00403403|O2|Outcome|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
1163196|NCT00403403|O1|Outcome|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
1163197|NCT00403403|O2|Outcome|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
1163198|NCT00403403|O1|Outcome|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
1163240|NCT00403234|P1|Participant Flow|Placebo|Placebo transdermal patch applied for 7-day wear.
1163199|NCT00403403|O2|Outcome|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
1163200|NCT00403403|O1|Outcome|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
1163201|NCT00403403|E2|Reported Event|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
1163202|NCT00403403|E1|Reported Event|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
1163203|NCT00403273|B3|Baseline|Total|Total of all reporting groups
1163204|NCT00403273|B2|Baseline|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
1163205|NCT00403273|B1|Baseline|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
1163206|NCT00403273|P2|Participant Flow|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
1163216|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
1163217|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
1163218|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
1163219|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
1163220|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
1163221|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
1163222|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
1163223|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
1163224|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
1163225|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
1163226|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
1163227|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
1163228|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
1163229|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
1163245|NCT00403234|E4|Reported Event|BTDS 30|Buprenorphine transdermal patch 10 + 20 mcg/h applied for 7-day wear
1163246|NCT00403234|E3|Reported Event|BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
1163247|NCT00403234|E2|Reported Event|BTDS 10|Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
1163248|NCT00403234|E1|Reported Event|Placebo|Placebo transdermal patch applied for 7-day wear.
1163249|NCT00403130|B1|Baseline|Gemcitabine + Paclitaxel + Bevacizumab|
1163250|NCT00403130|P1|Participant Flow|Gemcitabine + Paclitaxel + Bevacizumab|
1163251|NCT00403130|O1|Outcome|Bevacizumab + Gemcitabine + Paclitaxel|
1163252|NCT00403130|O1|Outcome|Bevacizumab + Gemcitabine + Paclitaxel|
1163253|NCT00403130|O1|Outcome|Bevacizumab + Gemcitabine + Paclitaxel|
1163254|NCT00403130|O1|Outcome|Bevacizumab + Gemcitabine + Paclitaxel|
1163255|NCT00403130|E1|Reported Event|Gemcitabine + Paclitaxel + Bevacizumab|
1163256|NCT00402987|B5|Baseline|Total|Total of all reporting groups
1163257|NCT00402987|B4|Baseline|Placebo|Dose 1 placebo followed 6-12 hours later by dose 2 placebo
1163258|NCT00402987|B3|Baseline|Celecoxib 100mg/50mg|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
1163259|NCT00402987|B2|Baseline|Celecoxib 100mg/Placebo|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo
1163260|NCT00402987|B1|Baseline|Celecoxib 50mg/50mg|Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
1163261|NCT00402987|P4|Participant Flow|Placebo|Dose 1 placebo followed 6-12 hours later by dose 2 placebo
1163262|NCT00402987|P3|Participant Flow|Celecoxib 100mg/50mg|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
1163263|NCT00402987|P2|Participant Flow|Celecoxib 100mg/Placebo|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo
1163264|NCT00402987|P1|Participant Flow|Celecoxib 50mg/50mg|Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
1163265|NCT00402987|O4|Outcome|Placebo|
1163266|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
1163267|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
1163268|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1163269|NCT00402987|O4|Outcome|Placebo|
1163270|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
1163271|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
1163272|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1163273|NCT00402987|O4|Outcome|Placebo|
1163274|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
1163275|NCT00402987|O2|Outcome|Celecoxib 100mg /Placebo|
1163276|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1163277|NCT00402987|O4|Outcome|Placebo|
1163278|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
1163279|NCT00402987|O2|Outcome|Celecoxib 100mg /Placebo|
1163280|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1163281|NCT00402987|O4|Outcome|Placebo|
1163282|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
1163283|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
1163284|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1163285|NCT00402987|O4|Outcome|Placebo|
1163286|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
1163287|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
1163288|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1163289|NCT00402987|O3|Outcome|Placebo|
1163290|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
1163291|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1163292|NCT00402987|O4|Outcome|Placebo|
1163293|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
1163294|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
1163295|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1163296|NCT00402987|O3|Outcome|Placebo|
1163297|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
1163298|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
1163299|NCT00402987|O4|Outcome|Placebo|
1163412|NCT00402987|O4|Outcome|Placebo|Dose 1 placebo followed 6-12 hours later by dose 2 placebo
1163413|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
1163414|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo
1163415|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
1163416|NCT00402987|O3|Outcome|Placebo|Dose 1 placebo followed 6-12 hours later by dose 2 placebo
1163417|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled
1163418|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
1163419|NCT00402987|O2|Outcome|Placebo|Dose 1 placebo followed 6-12 hours later by dose 2 placebo
1163420|NCT00402987|O1|Outcome|Celecoxib 100mg (Pooled)|Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled
1163421|NCT00402987|E4|Reported Event|Placebo|Dose 1 placebo followed 6-12 hours later by dose 2 placebo
1163422|NCT00402987|E3|Reported Event|Celecoxib 100mg/50mg|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
1163423|NCT00402987|E2|Reported Event|Celecoxib 100mg/Placebo|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo
1163424|NCT00402987|E1|Reported Event|Celecoxib 50mg/50mg|Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
1163425|NCT00402896|B1|Baseline|ZD6474|300 mg/day orally for 10 weeks.
1163426|NCT00402896|P1|Participant Flow|ZD6474|300 mg/day orally for 10 weeks.
1163427|NCT00402896|O1|Outcome|ZD6474|300 mg/day orally for 10 weeks.
1163428|NCT00402896|E1|Reported Event|ZD6474|300 mg/day orally for 10 weeks.
1163429|NCT00402883|B1|Baseline|Pemetrexed/Carboplatin/Radiotherapy and Bevacizumab|Induction treatment included: carboplatin AUC=5, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously weeks 1 and 4. Radiation was administered concurrently at a dose of 1.8 Gy/d weeks 1 to 7 to a total of 61.2 Gy per institutional guidelines. Consolidative therapy, following an 8-week break from chemoradiotherapy, included carboplatin AUC=6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously on week 16, repeated weeks 19 and 22. Folic acid (350 to 1,000 ug or equivalent) supplementation was administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinued study therapy. Vitamin B12(1,000ug) was administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinued therapy.
1163430|NCT00402883|P1|Participant Flow|Pemetrexed/Carboplatin/Radiotherapy and Bevacizumab|"Induction treatment included: carboplatin AUC=5, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously weeks 1 and 4. Radiation was administered concurrently at a dose of 1.8 Gy/d weeks 1 to 7 to a total of 61.2 Gy per institutional guidelines.~Consolidative therapy, following an 8-week break from chemoradiotherapy, included carboplatin AUC=6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously on week 16, repeated weeks 19 and 22. Folic acid (350 to 1,000 ug or equivalent) supplementation was administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinued study therapy. Vitamin B12(1,000ug) was administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinued therapy."
1163431|NCT00402883|O1|Outcome|Intervention|Induction treatment included: carboplatin AUC=5, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously weeks 1 and 4. Radiation was administered concurrently at a dose of 1.8 Gy/d weeks 1 to 7 to a total of 61.2 Gy per institutional guidelines. Consolidative therapy, following an 8-week break from chemoradiotherapy, included carboplatin AUC=6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously on week 16, repeated weeks 19 and 22. Folic acid (350 to 1,000 ug or equivalent) supplementation was administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinued study therapy. Vitamin B12(1,000ug) was administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinued therapy.
1163432|NCT00402883|E1|Reported Event|Intervention|Induction treatment included: carboplatin AUC=5, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously weeks 1 and 4. Radiation was administered concurrently at a dose of 1.8 Gy/d weeks 1 to 7 to a total of 61.2 Gy per institutional guidelines. Consolidative therapy, following an 8-week break from chemoradiotherapy, included carboplatin AUC=6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously on week 16, repeated weeks 19 and 22. Folic acid (350 to 1,000 ug or equivalent) supplementation was administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinued study therapy. Vitamin B12(1,000ug) was administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinued therapy.
1163433|NCT00402740|B1|Baseline|Group 1|
1163434|NCT00402740|P1|Participant Flow|Group 1|
1163435|NCT00402740|O1|Outcome|Group 1|
1163436|NCT00402740|O1|Outcome|Group 1|
1163437|NCT00402740|O1|Outcome|Group 1|
1163438|NCT00402740|O3|Outcome|Emboshield Gen 3|Participants receiving Emboshield Gen 3 Emboshield Gen3 success were counted per filter.
1163439|NCT00402740|O2|Outcome|Emboshield Pro Gen 5|Participants receiving Emboshield Pro Gen 5. Emboshield Pro success were counted per filter.
1163440|NCT00402740|O1|Outcome|Xact Stent|The Xact stent success were counted per subject
1163441|NCT00402740|O1|Outcome|Group 1|Includes only the most serious event for each subject and includes only each subject's first occurrence of the event.
1163442|NCT00402740|E1|Reported Event|Group 1|
1163443|NCT00402727|B3|Baseline|Total|Total of all reporting groups
1163444|NCT00402727|B2|Baseline|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
1163445|NCT00402727|B1|Baseline|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
1165050|NCT00398411|O2|Outcome|Placebo|identical appearing placebo
1163446|NCT00402727|P2|Participant Flow|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
1163447|NCT00402727|P1|Participant Flow|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
1163448|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
1163449|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
1163450|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
1163451|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
1163452|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
1163453|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
1163454|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
1163455|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
1163456|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
1163457|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
1163458|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
1163459|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
1163460|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
1163461|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
1163462|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
1163463|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
1163464|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
1163465|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
1163466|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
1163467|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
1163468|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
1163469|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
1163470|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
1163471|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
1163509|NCT00402688|O1|Outcome|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
1163472|NCT00402727|E2|Reported Event|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
1163473|NCT00402727|E1|Reported Event|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
1163474|NCT00402714|B3|Baseline|Total|Total of all reporting groups
1163475|NCT00402714|B2|Baseline|2 Pent/TBI|"Pentostatin and total body irradiation~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
1163476|NCT00402714|B1|Baseline|1 ECP and Pent/TBI|"Extracorporeal photopheresis, pentostatin and total body irradiation~extracorporeal photopheresis: Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen.~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
1163477|NCT00402714|P2|Participant Flow|Pent|"Pentostatin and total body irradiation~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
1163478|NCT00402714|P1|Participant Flow|ECP/Pent|"Extracorporeal photopheresis, pentostatin and total body irradiation~extracorporeal photopheresis: Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen.~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
1163479|NCT00402714|O2|Outcome|Pento TBI|"Pentostatin and total body irradiation~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
1163480|NCT00402714|O1|Outcome|ECP Pento TBI|"Extracorporeal photopheresis, pentostatin and total body irradiation~extracorporeal photopheresis: Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen.~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
1163481|NCT00402714|O2|Outcome|2 Pent/TBI|"Pentostatin and total body irradiation~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
1163482|NCT00402714|O1|Outcome|1 ECP and Pent/TBI|"Extracorporeal photopheresis, pentostatin and total body irradiation~extracorporeal photopheresis: Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen.~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
1163483|NCT00402714|E2|Reported Event|Pent|"Pentostatin and total body irradiation~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
1163484|NCT00402714|E1|Reported Event|ECP/Pent|"Extracorporeal photopheresis, pentostatin and total body irradiation~extracorporeal photopheresis: Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen.~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
1163485|NCT00402688|B4|Baseline|Total|Total of all reporting groups
1163486|NCT00402688|B3|Baseline|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
1163487|NCT00402688|B2|Baseline|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
1163488|NCT00402688|B1|Baseline|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
1163489|NCT00402688|P3|Participant Flow|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
1163490|NCT00402688|P2|Participant Flow|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
1163491|NCT00402688|P1|Participant Flow|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
1163492|NCT00402688|O3|Outcome|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
1163493|NCT00402688|O2|Outcome|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
1163494|NCT00402688|O1|Outcome|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
1163495|NCT00402688|O3|Outcome|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
1163496|NCT00402688|O2|Outcome|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
1163497|NCT00402688|O1|Outcome|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
1163498|NCT00402688|O3|Outcome|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
1163499|NCT00402688|O2|Outcome|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
1163500|NCT00402688|O1|Outcome|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
1163501|NCT00402688|O3|Outcome|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
1163502|NCT00402688|O2|Outcome|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
1163503|NCT00402688|O1|Outcome|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
1163504|NCT00402688|O3|Outcome|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
1163505|NCT00402688|O2|Outcome|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
1163506|NCT00402688|O1|Outcome|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
1163507|NCT00402688|O3|Outcome|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
1163508|NCT00402688|O2|Outcome|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
1165572|NCT00397033|B4|Baseline|Total|Total of all reporting groups
1163510|NCT00402688|E3|Reported Event|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
1163511|NCT00402688|E2|Reported Event|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
1163512|NCT00402688|E1|Reported Event|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
1163513|NCT00402649|B1|Baseline|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
1163514|NCT00402649|P1|Participant Flow|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
1163515|NCT00402649|O1|Outcome|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
1163516|NCT00402649|O1|Outcome|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
1163517|NCT00402649|O1|Outcome|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
1163518|NCT00402649|O1|Outcome|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
1163519|NCT00402649|O1|Outcome|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
1163520|NCT00402649|O1|Outcome|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
1163521|NCT00402649|O1|Outcome|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
1163522|NCT00402649|E1|Reported Event|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
1163523|NCT00402597|B6|Baseline|Total|Total of all reporting groups
1163524|NCT00402597|B5|Baseline|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
1163525|NCT00402597|B4|Baseline|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
1163526|NCT00402597|B3|Baseline|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
1163527|NCT00402597|B2|Baseline|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily)
1163528|NCT00402597|B1|Baseline|Placebo|One placebo tablet twice daily for 6 months.
1163529|NCT00402597|P5|Participant Flow|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
1163530|NCT00402597|P4|Participant Flow|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
1163531|NCT00402597|P3|Participant Flow|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
1163532|NCT00402597|P2|Participant Flow|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily)
1163533|NCT00402597|P1|Participant Flow|Placebo|One placebo tablet twice daily for 6 months.
1163534|NCT00402597|O5|Outcome|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
1163535|NCT00402597|O4|Outcome|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
1163536|NCT00402597|O3|Outcome|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
1163537|NCT00402597|O2|Outcome|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
1163538|NCT00402597|O1|Outcome|Placebo|One Placebo tablet twice daily for 6 months.
1163539|NCT00402597|O5|Outcome|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
1163540|NCT00402597|O4|Outcome|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
1163541|NCT00402597|O3|Outcome|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
1163542|NCT00402597|O2|Outcome|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
1163543|NCT00402597|O1|Outcome|Placebo|One Placebo tablet twice daily for 6 months.
1163544|NCT00402597|O5|Outcome|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
1163545|NCT00402597|O4|Outcome|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
1163546|NCT00402597|O3|Outcome|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
1163547|NCT00402597|O2|Outcome|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
1163548|NCT00402597|O1|Outcome|Placebo|One Placebo tablet twice daily for 6 months.
1163549|NCT00402597|O5|Outcome|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
1163550|NCT00402597|O4|Outcome|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
1163551|NCT00402597|O3|Outcome|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
1163552|NCT00402597|O2|Outcome|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
1163553|NCT00402597|O1|Outcome|Placebo|One Placebo tablet twice daily for 6 months.
1163554|NCT00402597|O5|Outcome|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
1163555|NCT00402597|O4|Outcome|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
1163556|NCT00402597|O3|Outcome|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
1163557|NCT00402597|O2|Outcome|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
1163558|NCT00402597|O1|Outcome|Placebo|One Placebo tablet twice daily for 6 months.
1163559|NCT00402597|O5|Outcome|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
1163560|NCT00402597|O4|Outcome|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
1163561|NCT00402597|O3|Outcome|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
1166189|NCT00395850|O4|Outcome|Disulfiram 500|Disulfiram at 500 mg/day
1163562|NCT00402597|O2|Outcome|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
1163563|NCT00402597|O1|Outcome|Placebo|One Placebo tablet twice daily for 6 months.
1163564|NCT00402597|E5|Reported Event|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
1163565|NCT00402597|E4|Reported Event|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
1163566|NCT00402597|E3|Reported Event|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
1163567|NCT00402597|E2|Reported Event|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
1163568|NCT00402597|E1|Reported Event|Placebo|One placebo tablet twice daily for 6 months.
1163569|NCT00402363|B5|Baseline|Total|Total of all reporting groups
1163570|NCT00402363|B4|Baseline|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
1163571|NCT00402363|B3|Baseline|Persistent AF, P-OM3|Participants with persistent AF receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
1163572|NCT00402363|B2|Baseline|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
1163573|NCT00402363|B1|Baseline|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 grams (g) per day for the first 7 days; 4 g per day thereafter through Week 24. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF in the participant's medical record.
1163574|NCT00402363|P4|Participant Flow|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
1163575|NCT00402363|P3|Participant Flow|Persistent AF, P-OM3|Participants with persistent AF receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
1163576|NCT00402363|P2|Participant Flow|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
1163577|NCT00402363|P1|Participant Flow|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 grams (g) per day for the first 7 days; 4 g per day thereafter through Week 24. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF in the participant's medical record.
1163578|NCT00402363|O6|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
1163579|NCT00402363|O5|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
1163580|NCT00402363|O4|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
1163581|NCT00402363|O3|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
1163582|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
1163583|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
1163584|NCT00402363|O6|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
1163585|NCT00402363|O5|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
1163586|NCT00402363|O4|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
1163587|NCT00402363|O3|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
1163588|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
1163589|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
1163590|NCT00402363|O6|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
1163591|NCT00402363|O5|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
1163592|NCT00402363|O4|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
1163593|NCT00402363|O3|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
1163594|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
1163595|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
1163596|NCT00402363|O2|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
1163597|NCT00402363|O1|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
1163598|NCT00402363|O4|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
1163599|NCT00402363|O3|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
1163600|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
1163601|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
1163602|NCT00402363|O2|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
1163603|NCT00402363|O1|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
1163604|NCT00402363|O4|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
1163605|NCT00402363|O3|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
1163606|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
1163607|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
1163608|NCT00402363|O2|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
1163609|NCT00402363|O1|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
1163610|NCT00402363|O4|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
1163611|NCT00402363|O3|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
1163612|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
1163613|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
1163614|NCT00402363|O2|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
1163615|NCT00402363|O1|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
1163616|NCT00402363|O4|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
1163617|NCT00402363|O3|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
1163618|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
1163619|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
1163620|NCT00402363|O2|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
1163621|NCT00402363|O1|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
1163622|NCT00402363|O4|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
1163623|NCT00402363|O3|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
1163624|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
1163625|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
1163626|NCT00402363|O4|Outcome|Combined, P-OM3|Participants with both paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
1163627|NCT00402363|O3|Outcome|Combined, Placebo|Participants with both paroxysmal and persistent AF receiving matching placebo
1163628|NCT00402363|O2|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
1163629|NCT00402363|O1|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
1163630|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
1163631|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
1163632|NCT00402363|E2|Reported Event|Prescription Omega-3 Acid Ethyl Esters|Participants receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
1163633|NCT00402363|E1|Reported Event|Placebo|Participants receiving matching placebo
1163634|NCT00402337|B6|Baseline|Total|Total of all reporting groups
1163635|NCT00402337|B5|Baseline|Placebo|Dose-matched placebo, oral administration, once per day.
1163636|NCT00402337|B4|Baseline|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
1163637|NCT00402337|B3|Baseline|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
1163795|NCT00402194|E2|Reported Event|Placebo|Treatment with double blinded placebo daily. Outcomes measured before and after 3 months of treatment.
1163638|NCT00402337|B2|Baseline|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day. One patient was randomized into the study but did not receive ≥ 1 dose of study drug, thus was not included in the Safety Population.
1163639|NCT00402337|B1|Baseline|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
1163640|NCT00402337|P5|Participant Flow|Placebo|Dose-matched placebo, oral administration, once per day.
1163641|NCT00402337|P4|Participant Flow|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
1163642|NCT00402337|P3|Participant Flow|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
1163643|NCT00402337|P2|Participant Flow|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
1163644|NCT00402337|P1|Participant Flow|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
1163645|NCT00402337|O5|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
1163646|NCT00402337|O4|Outcome|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
1163647|NCT00402337|O3|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
1163648|NCT00402337|O2|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
1163649|NCT00402337|O1|Outcome|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
1163650|NCT00402337|O5|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
1163651|NCT00402337|O4|Outcome|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
1163652|NCT00402337|O3|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
1163653|NCT00402337|O2|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
1163654|NCT00402337|O1|Outcome|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
1163655|NCT00402337|O5|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
1163656|NCT00402337|O4|Outcome|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
1163657|NCT00402337|O3|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
1163658|NCT00402337|O2|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
1163659|NCT00402337|O1|Outcome|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
1163660|NCT00402337|O5|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
1163661|NCT00402337|O4|Outcome|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
1163662|NCT00402337|O3|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
1163663|NCT00402337|O2|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
1163664|NCT00402337|O1|Outcome|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
1163665|NCT00402337|O5|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
1163666|NCT00402337|O4|Outcome|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
1163667|NCT00402337|O3|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
1163668|NCT00402337|O2|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
1163669|NCT00402337|O1|Outcome|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
1163670|NCT00402337|O5|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
1163671|NCT00402337|O4|Outcome|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
1163672|NCT00402337|O3|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
1163673|NCT00402337|O2|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
1163674|NCT00402337|O1|Outcome|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
1163675|NCT00402337|E5|Reported Event|Placebo|Dose-matched placebo, oral administration, once per day.
1163676|NCT00402337|E4|Reported Event|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
1163677|NCT00402337|E3|Reported Event|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
1163678|NCT00402337|E2|Reported Event|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
1163679|NCT00402337|E1|Reported Event|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
1163680|NCT00402324|B3|Baseline|Total|Total of all reporting groups
1163681|NCT00402324|B2|Baseline|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
1163682|NCT00402324|B1|Baseline|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
1163683|NCT00402324|P2|Participant Flow|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
1163684|NCT00402324|P1|Participant Flow|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
1163685|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
1163686|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
1163687|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
1163688|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
1163689|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
1163690|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
1163691|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
1163692|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
1163693|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
1163694|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
1163695|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
1163696|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
1163697|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
1163698|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
1163699|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
1163700|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
1163701|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
1163702|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
1163703|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
1163704|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
1163705|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
1163706|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
1163707|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
1163708|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
1163709|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
1163796|NCT00402194|E1|Reported Event|Treatment|Treatment with 100mg of losartan daily. Outcomes measured before and after 3 months of treatment.
1163797|NCT00402168|B3|Baseline|Total|Total of all reporting groups
1163710|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
1163711|NCT00402324|E2|Reported Event|Placebo|Placebo: placebo capsules, PO, at Q HS, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, PO, BID, daily for 6 weeks (following dose achieved in Study Period I).
1163712|NCT00402324|E1|Reported Event|Olanzapine|Olanzapine: 15mg, capsules, PO at Q HS, daily for 1 week followed by 5-20mg, capsules, PO at Q HS daily for 5 weeks (6 weeks total). Divalproex: dose to maintain blood levels of 75-125 ug/mL, PO, BID, daily for 6 weeks (following d ose achieved in Study Period I)
1163713|NCT00402285|B4|Baseline|Total|Total of all reporting groups
1163714|NCT00402285|B3|Baseline|Placebo|men took placebo for lycopene & placebo for fish oil.
1163715|NCT00402285|B2|Baseline|Fish Oil Supplement|"three 1g fish oil capsules daily including 1,098mg EPA & 549mg DHA fatty acid (Roche).~men took fish oil & placebo for lycopene."
1163716|NCT00402285|B1|Baseline|Lycopene Supplement|two 15mg lycopene soft gel capsules daily (Lyc-O-Mato). men took lycopene & placebo for fish oil.
1163717|NCT00402285|P3|Participant Flow|Placebo|men took placebo for lycopene & placebo for fish oil.
1163718|NCT00402285|P2|Participant Flow|Fish Oil Supplement|"three 1g fish oil capsules daily including 1,098mg EPA & 549mg DHA fatty acid (Roche).~men took fish oil & placebo for lycopene."
1163719|NCT00402285|P1|Participant Flow|Lycopene Supplement|two 15mg lycopene soft gel capsules daily (Lyc-O-Mato). men took lycopene & placebo for fish oil.
1163720|NCT00402285|O3|Outcome|Placebo|men took placebo for lycopene & placebo for fish oil.
1163721|NCT00402285|O2|Outcome|Fish Oil Supplement|"three 1g fish oil capsules daily including 1,098mg EPA & 549mg DHA fatty acid (Roche).~men took fish oil & placebo for lycopene."
1163722|NCT00402285|O1|Outcome|Lycopene Supplement|two 15mg lycopene soft gel capsules daily (Lyc-O-Mato). men took lycopene & placebo for fish oil.
1163723|NCT00402285|E1|Reported Event|All Participants|
1163724|NCT00402246|B3|Baseline|Total|Total of all reporting groups
1163725|NCT00402246|B2|Baseline|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
1163726|NCT00402246|B1|Baseline|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
1163727|NCT00402246|P2|Participant Flow|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
1163728|NCT00402246|P1|Participant Flow|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
1163729|NCT00402246|O1|Outcome|Enrolled Subjects|All enrolled subjects who completed some portion of the caregiver burden survey at 1 month visit
1163730|NCT00402246|O1|Outcome|Enrolled Subjects|All enrolled subjects who completed some portion of the caregiver burden survey at 1 month visit
1163731|NCT00402246|O1|Outcome|Enrolled Subjects|All enrolled subjects who completed some portion of the caregiver burden survey at 1 month visit
1163732|NCT00402246|O1|Outcome|Clinicians|Clinicians who responded to the survey
1163733|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
1163734|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
1163735|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
1163763|NCT00402233|P3|Participant Flow|Mirapex (Pramipexole 0.5 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
1163839|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
1163867|NCT00402103|O2|Outcome|Aliskiren 300mg/ Amlodipine 10mg Alone|Aliskiren 300mg and Amlodipine 10mg tablets once a day in the morning
1163736|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
1163737|NCT00402246|O1|Outcome|Patients With a Study CRT-D Device|Patients in either the Remote Arm or the In-office Arm who were implanted with a study CRT-D Device, as these are the only devices that have Left Ventricular leads
1163738|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
1163739|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
1163740|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
1163741|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
1163742|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
1163743|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
1163744|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
1163745|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
1163746|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
1163793|NCT00402194|O2|Outcome|Placebo|Treatment with double blinded placebo daily. Outcomes measured before and after 3 months of treatment.
1166190|NCT00395850|O3|Outcome|Disulfiram 375|Disulfiram at 375 mg/day
1163747|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
1163748|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
1163749|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
1163750|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
1163751|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
1163752|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
1163753|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
1163754|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
1163755|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
1163756|NCT00402246|E1|Reported Event|Enrolled Subjects|All enrolled subjects in the study
1163757|NCT00402233|B5|Baseline|Total|Total of all reporting groups
1163758|NCT00402233|B4|Baseline|Mirapex (Pramipexole 0.75 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
1163759|NCT00402233|B3|Baseline|Mirapex (Pramipexole 0.5 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
1163760|NCT00402233|B2|Baseline|Mirapex (Pramipexole 0.5 mg Tid)|Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
1163761|NCT00402233|B1|Baseline|Placebo|matching tablet
1163762|NCT00402233|P4|Participant Flow|Mirapex (Pramipexole 0.75 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
1163794|NCT00402194|O1|Outcome|Treatment|Treatment with 100mg of losartan daily. Outcomes measured before and after 3 months of treatment.
1164229|NCT00401401|E4|Reported Event|Zalutumumab 16 mg/kg|Zalutumumab 8 weekly infusions
1163764|NCT00402233|P2|Participant Flow|Mirapex (Pramipexole 0.5 mg Tid)|Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
1163765|NCT00402233|P1|Participant Flow|Placebo|matching tablet
1163766|NCT00402233|O4|Outcome|Mirapex (Pramipexole 0.75 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
1163767|NCT00402233|O3|Outcome|Mirapex (Pramipexole 0.5 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
1163768|NCT00402233|O2|Outcome|Mirapex (Pramipexole 0.5 mg Tid)|Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
1163769|NCT00402233|O1|Outcome|Placebo|matching tablet
1163770|NCT00402233|O4|Outcome|Mirapex (Pramipexole 0.75 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
1163771|NCT00402233|O3|Outcome|Mirapex (Pramipexole 0.5 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
1163772|NCT00402233|O2|Outcome|Mirapex (Pramipexole 0.5 mg Tid)|Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
1163773|NCT00402233|O1|Outcome|Placebo|matching tablet
1163774|NCT00402233|O4|Outcome|Mirapex (Pramipexole 0.75 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
1163775|NCT00402233|O3|Outcome|Mirapex (Pramipexole 0.5 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
1163776|NCT00402233|O2|Outcome|Mirapex (Pramipexole 0.5 mg Tid)|Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
1163777|NCT00402233|O1|Outcome|Placebo|matching tablet
1163778|NCT00402233|O4|Outcome|Mirapex (Pramipexole 0.75 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
1163779|NCT00402233|O3|Outcome|Mirapex (Pramipexole 0.5 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
1163780|NCT00402233|O2|Outcome|Mirapex (Pramipexole 0.5 mg Tid)|Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
1163781|NCT00402233|O1|Outcome|Placebo|matching tablet
1163782|NCT00402233|E4|Reported Event|Mirapex (Pramipexole 0.5 mg Tid)|Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
1163783|NCT00402233|E3|Reported Event|Mirapex (Pramipexole 0.75 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
1163784|NCT00402233|E2|Reported Event|Mirapex (Pramipexole 0.5 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
1163785|NCT00402233|E1|Reported Event|Placebo|matching tablet
1163786|NCT00402194|B3|Baseline|Total|Total of all reporting groups
1163787|NCT00402194|B2|Baseline|Placebo|Placebo
1163788|NCT00402194|B1|Baseline|Treatment|Treatment with 100mg of losartan daily or placebo. Outcomes measured before and after 3 months of treatment.
1163789|NCT00402194|P2|Participant Flow|Placebo|Treatment with double blinded placebo daily. Outcomes measured before and after 3 months of treatment.
1163790|NCT00402194|P1|Participant Flow|Treatment|Treatment with 100mg of losartan daily. Outcomes measured before and after 3 months of treatment.
1163791|NCT00402194|O2|Outcome|Placebo|Treatment with double blinded placebo daily. Outcomes measured before and after 3 months of treatment.
1163792|NCT00402194|O1|Outcome|Treatment|Treatment with 100mg of losartan daily. Outcomes measured before and after 3 months of treatment.
1163798|NCT00402168|B2|Baseline|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
1163799|NCT00402168|B1|Baseline|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
1163800|NCT00402168|P2|Participant Flow|Calcineurin Inhibitor (CNI)|Participants received a calcineurin inhibitor (CNI)-based immunosuppressive regimen, Cyclosporin A (CsA) and tacrolimus (TAC). CsA was to be adjusted to maintain a range of trough serum concentrations of 100 - 250 nanograms per milliliter (ng/mL). TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the long term (LT) treatment period participants were allowed to switch to belatacept treatment arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
1163801|NCT00402168|P1|Participant Flow|Belatacept 5 mg/kg|Belatacept 5 milligrams per kilogram of body weight (mg/kg) given intravenously (IV) every 28 days.
1163802|NCT00402168|O1|Outcome|Belatacept 5 mg/kg in Participants Switched During LT Period|During the long term treatment period participants were allowed to switch from CNI to belatacept. For those switching to belatacept, the CNI dose was tapered and discontinued, after which they received belatacept 5 mg/kg IV every 2 weeks for 2 months. Thereafter, they received belatacept 5 mg/kg IV every 28 days.
1163803|NCT00402168|O1|Outcome|Belatacept 5 mg/kg in Participants Switched During LT Period|During the long term treatment period participants who had been randomized to CNI were allowed to switch to belatacept. For those switching to belatacept, the CNI dose was tapered and discontinued, after which they received belatacept 5 mg/kg IV every 2 weeks for 2 months. Thereafter, they received belatacept 5 mg/kg IV every 28 days.
1163804|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
1163805|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
1163806|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
1163807|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
1163808|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
1163809|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
1163810|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
1163811|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
1163812|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
1163813|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
1163814|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
1163815|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
1163816|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
1163817|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
1163866|NCT00402103|O3|Outcome|Aliskiren 300mg/ Amlodipine 10mg/ HCTZ|Aliskiren 300mg and Amlodipine 10mg tablets and HCTZ capsules once a day in the morning
1164230|NCT00401401|E3|Reported Event|Zalutumumab 12 mg/kg|Zalutumumab 8 weekly infusions
1163818|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
1163819|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
1163820|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
1163821|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
1163822|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
1163823|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
1163824|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
1163825|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
1163826|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
1163827|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
1163828|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
1163829|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
1163830|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
1163831|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
1163832|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
1163833|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
1163834|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
1163835|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
1163836|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
1163837|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg given IV every 28 days.
1163838|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
1163840|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
1163841|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
1163842|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm by Year 3.
1163843|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 milligrams per kilogram of body weight (mg/kg) given intravenously (IV) every 28 days.
1163844|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
1163845|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
1163846|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
1163847|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
1163848|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
1163849|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
1163850|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
1163851|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg was given IV every 28 days.
1163852|NCT00402168|E3|Reported Event|Belatacept 5 mg/kg in Participants Switched During LT Period|During the long term treatment period participants were allowed to switch from CNI to Belatacept. For those switching to Belatacept, the CNI dose was tapered and discontinued, after which they received Belatacept 5 mg/kg IV every 2 weeks for 2 months. Thereafter, they received Belatacept 5 mg/kg IV every 28 days. Adverse events reported for participants who were switched from Calcineurin Inhibitor (CNI) treatment to Belatacept 5 mg/kg during the LT period on or after their first Belatacept dose.
1163853|NCT00402168|E2|Reported Event|Calcineurin Inhibitor (CNI)|Participants received a calcineurin inhibitor (CNI)-based immunosuppressive regimen, Cyclosporin A (CsA) and tacrolimus (TAC). CsA was to be adjusted to maintain a range of trough serum concentrations of 100 - 250 nanograms per milliliter (ng/mL). TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the long term (LT) treatment period participants were allowed to switch to Belatacept treatment arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the Belatacept arm. Adverse events reported for participants who were treated with only CNI for the entire study and those who were later switched from Calcineurin Inhibitor (CNI) treatment to Belatacept 5 mg/kg during the LT period prior to their first Belatacept dose.
1163854|NCT00402168|E1|Reported Event|Belatacept 5 mg/kg|Belatacept 5 milligrams per kilogram of body weight (mg/kg) given intravenously (IV) every 28 days. Adverse events reported for participants who were treated with only Belatacept throughout the study.
1163855|NCT00402103|B3|Baseline|Total|Total of all reporting groups
1163856|NCT00402103|B2|Baseline|Aliskiren/Amlodipine/HCTZ|Aliskiren and Amlodipine tablets and HCTZ capsules once a day in the morning
1163857|NCT00402103|B1|Baseline|Aliskiren/Amlodipine|Aliskiren and Amlodipine tablets once a day in the morning
1163858|NCT00402103|P2|Participant Flow|Aliskiren/Amlodipine/HCTZ|Aliskiren and Amlodipine tablets and HCTZ capsules once a day in the morning
1163859|NCT00402103|P1|Participant Flow|Aliskiren/Amlodipine|Aliskiren and Amlodipine tablets once a day in the morning
1163860|NCT00402103|O2|Outcome|Aliskiren/Amlodipine/HCTZ|Aliskiren and Amlodipine tablets and HCTZ capsules once a day in the morning
1163861|NCT00402103|O1|Outcome|Aliskiren/Amlodipine|Aliskiren and Amlodipine tablets once a day in the morning
1163862|NCT00402103|O2|Outcome|Aliskiren/Amlodipine/HCTZ|Aliskiren and Amlodipine tablets and HCTZ capsules once a day in the morning
1163863|NCT00402103|O1|Outcome|Aliskiren/Amlodipine|Aliskiren and Amlodipine tablets once a day in the morning
1163864|NCT00402103|O2|Outcome|Aliskiren/Amlodipine/HCTZ|Aliskiren and Amlodipine tablets and HCTZ capsules once a day in the morning
1163865|NCT00402103|O1|Outcome|Aliskiren/Amlodipine|Aliskiren and Amlodipine tablets once a day in the morning
1163868|NCT00402103|O1|Outcome|Aliskiren 150mg/ Amlodipine 5mg Alone|Aliskiren 150mg and Amlodipine 5mg tablets once a day in the morning
1163869|NCT00402103|E3|Reported Event|Aliskiren 300mg/ Amlodipine 10mg/ HCTZ|Aliskiren 300mg and Amlodipine 10mg tablets and HCTZ capsules once a day in the morning
1163870|NCT00402103|E2|Reported Event|Aliskiren 300mg/ Amlodipine 10mg Alone|Aliskiren 300mg and Amlodipine 10mg tablets once a day in the morning
1163871|NCT00402103|E1|Reported Event|Aliskiren 150mg/ Amlodipine 5mg Alone|Aliskiren 150mg and Amlodipine 5mg tablets once a day in the morning
1163872|NCT00402051|B3|Baseline|Total|Total of all reporting groups
1163873|NCT00402051|B2|Baseline|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
1163874|NCT00402051|B1|Baseline|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
1163875|NCT00402051|P2|Participant Flow|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
1163876|NCT00402051|P1|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
1163877|NCT00402051|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
1163878|NCT00402051|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
1163879|NCT00402051|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
1163880|NCT00402051|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
1163881|NCT00402051|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
1163882|NCT00402051|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
1163883|NCT00402051|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
1163884|NCT00402051|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
1163885|NCT00402051|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
1163886|NCT00402051|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
1163887|NCT00402051|E2|Reported Event|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
1163888|NCT00402051|E1|Reported Event|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
1163889|NCT00402025|B4|Baseline|Total|Total of all reporting groups
1163890|NCT00402025|B3|Baseline|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
1163891|NCT00402025|B2|Baseline|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
1163892|NCT00402025|B1|Baseline|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
1163893|NCT00402025|P3|Participant Flow|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
1163894|NCT00402025|P2|Participant Flow|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
1163895|NCT00402025|P1|Participant Flow|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴plaque-forming units (PFU)/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
1163896|NCT00402025|O3|Outcome|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
1163897|NCT00402025|O2|Outcome|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
1163898|NCT00402025|O1|Outcome|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
1163940|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
1163899|NCT00402025|O3|Outcome|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
1163900|NCT00402025|O2|Outcome|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
1163901|NCT00402025|O1|Outcome|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
1163902|NCT00402025|O3|Outcome|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
1163903|NCT00402025|O2|Outcome|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
1163904|NCT00402025|O1|Outcome|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
1163905|NCT00402025|O3|Outcome|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
1163906|NCT00402025|O2|Outcome|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
1163907|NCT00402025|O1|Outcome|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
1163908|NCT00402025|O3|Outcome|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
1163909|NCT00402025|O2|Outcome|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
1163910|NCT00402025|O1|Outcome|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
1163911|NCT00402025|O3|Outcome|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
1163912|NCT00402025|O2|Outcome|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
1163913|NCT00402025|O1|Outcome|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
1163914|NCT00402025|E3|Reported Event|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
1163915|NCT00402025|E2|Reported Event|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
1163916|NCT00402025|E1|Reported Event|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
1163917|NCT00401973|B4|Baseline|Total|Total of all reporting groups
1163974|NCT00401882|P1|Participant Flow|Additional Doses of Epinephrine|Epinephrine: additional doses Epinephrine (1 mg) IV given as part of standard of care in cardiac arrest
1163918|NCT00401973|B3|Baseline|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
1163919|NCT00401973|B2|Baseline|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
1163920|NCT00401973|B1|Baseline|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
1163921|NCT00401973|P3|Participant Flow|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
1163922|NCT00401973|P2|Participant Flow|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
1163923|NCT00401973|P1|Participant Flow|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
1163924|NCT00401973|O2|Outcome|22 Weeks|"Combined treatment groups:~olanzapine plus behavioral information [olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks].~Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information [olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)].~Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information [olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)]."
1163925|NCT00401973|O1|Outcome|2 Weeks|"Combined treatment groups:~olanzapine plus behavioral information [olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks].~Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information [olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)].~Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information [olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)]."
1163926|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
1163927|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
1163928|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
1163929|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
1163930|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
1163931|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
1163932|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
1163933|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
1163934|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
1163935|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
1163936|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
1163937|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
1163938|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
1163939|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
1163941|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
1163942|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
1163943|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
1163944|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
1163945|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
1163946|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
1163947|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
1163948|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
1163949|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
1163950|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
1163951|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
1163952|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
1163953|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
1163954|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
1163955|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
1163956|NCT00401973|E3|Reported Event|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
1163957|NCT00401973|E2|Reported Event|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
1163958|NCT00401973|E1|Reported Event|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
1163959|NCT00401960|B3|Baseline|Total|Total of all reporting groups
1163960|NCT00401960|B2|Baseline|Standard of Care Group|as per study description
1163961|NCT00401960|B1|Baseline|Adjunctive Daptomycin Group|please see study description for study enrollment
1163962|NCT00401960|P2|Participant Flow|Standard of Care Group|as per study description
1163963|NCT00401960|P1|Participant Flow|Adjunctive Daptomycin Group|please see study description for study enrollment
1163964|NCT00401960|O2|Outcome|Standard of Care|Patients with enterococcal endocarditis who elect to receive standard of care therapy as prescribed by their primary physician
1163965|NCT00401960|O1|Outcome|Daptomycin Adjunctive Group|"Patients with enterococcal endocarditis who elect to receive daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving~Daptomycin: daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving for native valve enterococcal endocarditis"
1163966|NCT00401960|O2|Outcome|Standard of Care Group|as per study description
1163967|NCT00401960|O1|Outcome|Adjunctive Daptomycin Group|please see study description for study enrollment
1163968|NCT00401960|E2|Reported Event|Standard of Care Group|as per study description
1163969|NCT00401960|E1|Reported Event|Adjunctive Daptomycin Group|please see study description for study enrollment
1163970|NCT00401882|B3|Baseline|Total|Total of all reporting groups
1163971|NCT00401882|B2|Baseline|Metoprolol|Metoprolol 5 mg IV (up to two doses only) instead of additional epinephrine doses in cardiac arrest
1163972|NCT00401882|B1|Baseline|Additional Epinephrine Doses|Additional Epinephrine (1 mg) IV doses as part of standard of care in cardiac arrest
1163973|NCT00401882|P2|Participant Flow|Metoprolol Instead of Additional Epinephrine Doses|Metoprolol: Metoprolol 5 mg IV (up to two times) instead of additional doses of epinephrine
1163975|NCT00401882|O2|Outcome|Metoprolol|Metoprolol 5 mg IV (up to two doses only) instead of additional epinephrine doses in cardiac arrest
1163976|NCT00401882|O1|Outcome|Additional Epinephrine Doses|Additional Epinephrine (1 mg) IV doses as part of standard of care in cardiac arrest
1163977|NCT00401882|O2|Outcome|Metoprolol|Metoprolol 5 mg IV (up to two doses only) instead of additional epinephrine doses in cardiac arrest
1163978|NCT00401882|O1|Outcome|Additional Epinephrine Doses|Additional Epinephrine (1 mg) IV doses as part of standard of care in cardiac arrest
1163979|NCT00401882|O2|Outcome|Metoprolol|Metoprolol 5 mg IV (up to two doses only) instead of additional epinephrine doses in cardiac arrest
1163980|NCT00401882|O1|Outcome|Additional Epinephrine Doses|Additional Epinephrine (1 mg) IV doses as part of standard of care in cardiac arrest
1163981|NCT00401882|O2|Outcome|Metoprolol Instead of Additional Epinephrine Doses|Metoprolol: Metoprolol 5mg IV (up to two times only) instead of additional epinephrine doses
1163982|NCT00401882|O1|Outcome|Additional Doses of Epinephrine|Epinephrine: Additional doses of epinephrine IV (1 mg) given as part of standard of care in cardiac arrest
1163983|NCT00401882|O2|Outcome|Metoprolol Instead of Additional Epinephrine Doses|"IV metoprolol 5 mg. (up to 2 times only) during cardiac arrest will be given instead of additional Epinephrine doses~Metoprolol: Metoprolol 5 mg IV (up to two times only) instead of epinephrine additional doses"
1163984|NCT00401882|O1|Outcome|Additional Epinephrine Doses|"Additional doses of Epinephrine (1 mg) given as part of standard of care during cardiac arrest~Epinephrine: Epinephrine (1 mg) IV additional doses"
1163985|NCT00401882|O2|Outcome|Metoprolol Instead of Additional Epinephrine Doses|Metoprolol 5 mg IV (up to 2 times) instead of additional epinephrine doses
1163986|NCT00401882|O1|Outcome|Additional Doses of Epinephrine|Epinephrine: Additional doses of epinephrine (1 mg IV) given as part of standard of care during cardiac arrest
1163987|NCT00401882|E2|Reported Event|Metoprolol Instead of Additional Doses of Epinephrine|Metoprolol: Metoprolol 5 mg IV (up to two times) instead of additional epinephrine doses
1163988|NCT00401882|E1|Reported Event|Additional Doses of Epinephrine|Epinephrine: Additional doses epinephrine (1 mg IV) as part of standard of care during cardiac arrest
1163989|NCT00401843|B4|Baseline|Total|Total of all reporting groups
1163990|NCT00401843|B3|Baseline|Part 2 - Bortezomib + Siltuximab|"Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity.~Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles."
1163991|NCT00401843|B2|Baseline|Part 2 - Bortezomib + Placebo|"Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase.~Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles."
1163992|NCT00401843|B1|Baseline|Part 1 - Bortezomib + Siltuximab|Siltuximab 6 milligram per kilogram (mg/kg) will be administered as intravenous infusion once every 2 weeks along with bortezomib 1.3 milligram per square meter (mg/m^2) during cycle 1.
1163993|NCT00401843|P3|Participant Flow|Part 2 - Bortezomib + Siltuximab|"Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity.~Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles."
1163994|NCT00401843|P2|Participant Flow|Part 2 - Bortezomib + Placebo|"Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase.~Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles."
1163995|NCT00401843|P1|Participant Flow|Part 1 - Bortezomib + Siltuximab|Siltuximab 6 milligram per kilogram (mg/kg) will be administered as intravenous infusion once every 2 weeks along with bortezomib 1.3 milligram per square meter (mg/m^2) during cycle 1.
1164043|NCT00401830|E2|Reported Event|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
1164044|NCT00401830|E1|Reported Event|Placebo|Matching placebo tablet (administered twice daily)
1164045|NCT00401778|B4|Baseline|Total|Total of all reporting groups
1164046|NCT00401778|B3|Baseline|Everolimus 10 mg|Everolimus dose of 10 mg/day for 21-28 days sequentially taken orally in tablet form.
1164047|NCT00401778|B2|Baseline|Everolimus 5 mg|Everolimus dose of 5 mg/day for 21-28 days sequentially taken orally in tablet form.
1164048|NCT00401778|B1|Baseline|Control|No everolimus taken.
1164231|NCT00401401|E2|Reported Event|Zalutumumab 8 mg/kg|Zalutumumab 8 weeky infusions
1163996|NCT00401843|O3|Outcome|Part 2 - Bortezomib + Siltuximab|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
1163997|NCT00401843|O2|Outcome|Part 2 - Bortezomib + Placebo|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
1163998|NCT00401843|O1|Outcome|Part 1 - Bortezomib + Siltuximab|Siltuximab 6 milligram per kilogram (mg/kg) will be administered as intravenous infusion once every 2 weeks along with bortezomib 1.3 milligram per square meter (mg/m^2) during cycle 1.
1163999|NCT00401843|O2|Outcome|Part 2 - Bortezomib + Siltuximab|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
1164000|NCT00401843|O1|Outcome|Part 2 - Bortezomib + Placebo|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
1164001|NCT00401843|O2|Outcome|Part 2 - Bortezomib + Siltuximab|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
1164002|NCT00401843|O1|Outcome|Part 2 - Bortezomib + Placebo|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
1164003|NCT00401843|O2|Outcome|Part 2 - Bortezomib + Siltuximab|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
1164004|NCT00401843|O1|Outcome|Part 2 - Bortezomib + Placebo|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
1164049|NCT00401778|P3|Participant Flow|Everolimus 10 mg|Everolimus dose of 10 mg/day for 21-28 days sequentially taken orally in tablet form.
1166191|NCT00395850|O2|Outcome|Disulfiram 250|disulfiram at 250 mg/day
1164005|NCT00401843|O2|Outcome|Part 2 - Bortezomib + Siltuximab|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
1164006|NCT00401843|O1|Outcome|Part 2 - Bortezomib + Placebo|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
1164007|NCT00401843|E3|Reported Event|Part 2 - Bortezomib + Siltuximab|"Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity.~Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles."
1164008|NCT00401843|E2|Reported Event|Part 2 - Bortezomib + Placebo|"Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase.~Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles."
1164009|NCT00401843|E1|Reported Event|Part 1 - Bortezomib + Siltuximab|Siltuximab 6 milligram per kilogram (mg/kg) will be administered as intravenous infusion once every 2 weeks along with bortezomib 1.3 milligram per square meter (mg/m^2) during cycle 1.
1164010|NCT00401830|B3|Baseline|Total|Total of all reporting groups
1164011|NCT00401830|B2|Baseline|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
1164012|NCT00401830|B1|Baseline|Placebo|Matching placebo tablet (administered twice daily)
1164013|NCT00401830|P2|Participant Flow|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
1164014|NCT00401830|P1|Participant Flow|Placebo|Matching placebo tablet (administered twice daily)
1164015|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
1164016|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
1164017|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
1164018|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
1164019|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
1164020|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
1164021|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
1164022|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
1164023|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
1164024|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
1164025|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
1164026|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
1164027|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
1164028|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
1164029|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
1164030|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
1164031|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
1164032|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
1164033|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
1164034|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
1164035|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
1164036|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
1164037|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
1164038|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
1164039|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
1164040|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
1164041|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
1164042|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
1166192|NCT00395850|O1|Outcome|Placebo|microcrystalline cellulose
1164050|NCT00401778|P2|Participant Flow|Everolimus 5 mg|Everolimus dose of 5 mg/day for 21-28 days sequentially taken orally in tablet form.
1164051|NCT00401778|P1|Participant Flow|Control|No everolimus taken.
1164052|NCT00401778|O2|Outcome|Everolimus 5 or 10 mg|Everolimus dose of 5 or 10 mg/day for 21-28 days sequentially taken orally in tablet form.
1164053|NCT00401778|O1|Outcome|Control|No everolimus taken.
1164054|NCT00401778|O3|Outcome|Everolimus 10 mg|Everolimus dose of 10 mg/day for 21-28 days sequentially taken orally in tablet form.
1164055|NCT00401778|O2|Outcome|Everolimus 5 mg|Everolimus dose of 5 mg/day for 21-28 days sequentially taken orally in tablet form.
1164056|NCT00401778|O1|Outcome|Control|No everolimus taken.
1164057|NCT00401778|O3|Outcome|Everolimus 10 mg|Everolimus dose of 10 mg/day for 21-28 days sequentially taken orally in tablet form.
1164058|NCT00401778|O2|Outcome|Everolimus 5 mg|Everolimus dose of 5 mg/day for 21-28 days sequentially taken orally in tablet form.
1164059|NCT00401778|O1|Outcome|Control|No everolimus taken.
1164060|NCT00401778|E2|Reported Event|Everolimus 5 & 10 mg|Everolimus dose of 5 or 10 mg/day for 21-28 days sequentially taken orally in tablet form.
1164061|NCT00401778|E1|Reported Event|Control|No everolimus taken.
1164062|NCT00401752|B3|Baseline|Total|Total of all reporting groups
1164063|NCT00401752|B2|Baseline|Ranitidine|ranitidine 150 mg capsule bid oral administration
1164064|NCT00401752|B1|Baseline|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
1164065|NCT00401752|P2|Participant Flow|Ranitidine|ranitidine 150 mg capsule bid oral administration
1164066|NCT00401752|P1|Participant Flow|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
1164067|NCT00401752|O2|Outcome|Ranitidine|ranitidine 150 mg capsule bid oral administration
1164068|NCT00401752|O1|Outcome|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
1164069|NCT00401752|O2|Outcome|Ranitidine|ranitidine 150 mg capsule bid oral administration
1164070|NCT00401752|O1|Outcome|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
1164071|NCT00401752|O2|Outcome|Ranitidine|ranitidine 150 mg capsule bid oral administration
1164072|NCT00401752|O1|Outcome|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
1164073|NCT00401752|O2|Outcome|Ranitidine|ranitidine 150 mg capsule bid oral administration
1164074|NCT00401752|O1|Outcome|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
1164075|NCT00401752|O2|Outcome|Ranitidine|ranitidine 150 mg capsule bid oral administration
1164076|NCT00401752|O1|Outcome|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
1164077|NCT00401752|O2|Outcome|Ranitidine|ranitidine 150 mg capsule bid oral administration
1164078|NCT00401752|O1|Outcome|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
1164079|NCT00401752|E2|Reported Event|Ranitidine|ranitidine 150 mg capsule bid oral administration
1164080|NCT00401752|E1|Reported Event|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
1164081|NCT00401726|B3|Baseline|Total|Total of all reporting groups
1164082|NCT00401726|B2|Baseline|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
1164083|NCT00401726|B1|Baseline|Venlafaxine Extended Release (ER)|75-225 mg per day
1164084|NCT00401726|P2|Participant Flow|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
1164085|NCT00401726|P1|Participant Flow|Venlafaxine Extended Release (ER)|75-225 mg per day
1164086|NCT00401726|O2|Outcome|Venlafaxine Extended Release (ER) Plus Dialogues|"Venlafaxine ER 75-225 mg per day plus Dialogues Time to Talk program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication."
1164087|NCT00401726|O1|Outcome|Venlafaxine Extended Release (ER)|75-225 mg per day
1164088|NCT00401726|O2|Outcome|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
1164089|NCT00401726|O1|Outcome|Venlafaxine Extended Release (ER)|75-225 mg per day
1164090|NCT00401726|O2|Outcome|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
1164091|NCT00401726|O1|Outcome|Venlafaxine Extended Release (ER)|75-225 mg per day
1164092|NCT00401726|O2|Outcome|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
1164093|NCT00401726|O1|Outcome|Venlafaxine Extended Release (ER)|75-225 mg per day
1164094|NCT00401726|O2|Outcome|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
1164095|NCT00401726|O1|Outcome|Venlafaxine Extended Release (ER)|75-225 mg per day
1164096|NCT00401726|O2|Outcome|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
1164097|NCT00401726|O1|Outcome|Venlafaxine Extended Release (ER)|75-225 mg per day
1164136|NCT00401544|O4|Outcome|Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164098|NCT00401726|O2|Outcome|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
1164099|NCT00401726|O1|Outcome|Venlafaxine Extended Release (ER)|75-225 mg per day
1164100|NCT00401726|O2|Outcome|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
1164101|NCT00401726|O1|Outcome|Venlafaxine Extended Release (ER)|75-225 mg per day
1164102|NCT00401726|E2|Reported Event|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
1164103|NCT00401726|E1|Reported Event|Venlafaxine Extended Release (ER)|75-225 mg per day
1164104|NCT00401622|B3|Baseline|Total|Total of all reporting groups
1164105|NCT00401622|B2|Baseline|Standard Care|Control group receiving standard care with a traditional blood glucose monitoring system
1164106|NCT00401622|B1|Baseline|OneTouch® Ultra®2 System|Test care group assigned to OneTouch® Ultra®2 System
1164107|NCT00401622|P2|Participant Flow|Standard Care|Control group receiving standard care with a traditional blood glucose monitoring system
1164108|NCT00401622|P1|Participant Flow|OneTouch® Ultra®2 System|Test care group assigned to OneTouch® Ultra®2 System
1164109|NCT00401622|O2|Outcome|Standard Care|Control group receiving standard care with a traditional blood glucose monitoring system
1164110|NCT00401622|O1|Outcome|OneTouch® Ultra®2 System|Test care group assigned to OneTouch® Ultra®2 System
1164111|NCT00401622|O2|Outcome|Standard Care|Control group receiving standard care with a traditional blood glucose monitoring system
1164112|NCT00401622|O1|Outcome|OneTouch® Ultra®2 System|Test care group assigned to OneTouch® Ultra®2 System
1164113|NCT00401622|E2|Reported Event|Standard Care|Control group receiving standard care with a traditional blood glucose monitoring system
1164114|NCT00401622|E1|Reported Event|OneTouch® Ultra®2 System|Test care group assigned to OneTouch® Ultra®2 System
1164115|NCT00401544|B5|Baseline|Total|Total of all reporting groups
1164116|NCT00401544|B4|Baseline|Darbepoetin Alfa 500 μg Plus Iron|Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164117|NCT00401544|B3|Baseline|Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164118|NCT00401544|B2|Baseline|Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164119|NCT00401544|B1|Baseline|Darbepoetin Alfa 300 μg Plus Iron|Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164120|NCT00401544|P4|Participant Flow|Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164121|NCT00401544|P3|Participant Flow|Darbepoetin Alfa 500 μg Plus Iron|Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164122|NCT00401544|P2|Participant Flow|Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164123|NCT00401544|P1|Participant Flow|Darbepoetin Alfa 300 μg Plus Iron|Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164124|NCT00401544|O2|Outcome|Combined With Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164125|NCT00401544|O1|Outcome|Combined Without Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164126|NCT00401544|O2|Outcome|Combined Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164127|NCT00401544|O1|Outcome|Combined Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164128|NCT00401544|O2|Outcome|Combined With Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164129|NCT00401544|O1|Outcome|Combined Without Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164130|NCT00401544|O2|Outcome|Combined Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164131|NCT00401544|O1|Outcome|Combined Darbepoetin Alfa 300|Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164132|NCT00401544|O2|Outcome|Combined With Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164133|NCT00401544|O1|Outcome|Combined Without Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164134|NCT00401544|O2|Outcome|Combined Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164135|NCT00401544|O1|Outcome|Combined Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164215|NCT00401401|O2|Outcome|Zalutumumab 8 mg/kg|Zalutumumab 8 weeky infusions
1164137|NCT00401544|O3|Outcome|Darbepoetin Alfa 500 μg Plus Iron|Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164138|NCT00401544|O2|Outcome|Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164139|NCT00401544|O1|Outcome|Darbepoetin Alfa 300 μg Plus Iron|Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164140|NCT00401544|O2|Outcome|Combined With Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164141|NCT00401544|O1|Outcome|Combined Without Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164142|NCT00401544|O2|Outcome|Combined Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164143|NCT00401544|O1|Outcome|Combined Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164144|NCT00401544|O2|Outcome|Combined With Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164145|NCT00401544|O1|Outcome|Combined Without Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164146|NCT00401544|O2|Outcome|Combined Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164147|NCT00401544|O1|Outcome|Combined Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164148|NCT00401544|O2|Outcome|Combined With Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164149|NCT00401544|O1|Outcome|Combined Without Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164150|NCT00401544|O2|Outcome|Combined Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164151|NCT00401544|O1|Outcome|Combined Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164152|NCT00401544|O2|Outcome|Combined With Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164153|NCT00401544|O1|Outcome|Combined Without Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164154|NCT00401544|O2|Outcome|Combined Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164155|NCT00401544|O1|Outcome|Combined Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164156|NCT00401544|E4|Reported Event|Darbepoetin Alfa 500 µg Plus Iron|Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164157|NCT00401544|E3|Reported Event|Darbepoetin Alfa 500 µg (Without Iron)|Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164158|NCT00401544|E2|Reported Event|Darbepoetin Alfa 300 µg Plus Iron|Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164159|NCT00401544|E1|Reported Event|Darbepoetin Alfa 300 µg (Without IV Iron)|Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
1164160|NCT00401531|B3|Baseline|Total|Total of all reporting groups
1164161|NCT00401531|B2|Baseline|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
1164162|NCT00401531|B1|Baseline|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
1164163|NCT00401531|P2|Participant Flow|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
1164164|NCT00401531|P1|Participant Flow|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
1164165|NCT00401531|O2|Outcome|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
1164166|NCT00401531|O1|Outcome|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
1164167|NCT00401531|O2|Outcome|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
1164168|NCT00401531|O1|Outcome|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
1164169|NCT00401531|O2|Outcome|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
1164170|NCT00401531|O1|Outcome|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
1164171|NCT00401531|O2|Outcome|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
1164172|NCT00401531|O1|Outcome|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
1164173|NCT00401531|O2|Outcome|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
1164174|NCT00401531|O1|Outcome|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
1164175|NCT00401531|O2|Outcome|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
1164176|NCT00401531|O1|Outcome|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
1164177|NCT00401531|E2|Reported Event|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
1164178|NCT00401531|E1|Reported Event|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
1164179|NCT00401414|B4|Baseline|Total|Total of all reporting groups
1164180|NCT00401414|B3|Baseline|Dosing Algorithm C|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm C was generated as an update of dosing Algorithm B and was based upon additional patient data, similar to what was described above for Algorithm B, from the prospective accrual of 203 patients in the CROWN trial. The major difference between Algorithm B and Algorithm C was an update of the half maximal inhibitory concentration (IC50) estimate for each VKORC1 haplotype in the model used to generate Algorithm B to reflect warfarin's PD effect as evident in the acquired patient data.
1164181|NCT00401414|B2|Baseline|Dosing Algorithm B|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm B was generated from an analysis of warfarin dose, INR, genetic factors, demographic factors and concomitant drug therapy from an initial prospective group of 74 patients treated using Algorithm A. Using these data, a mechanistic concentration-INR model was constructed to refine the estimates of the effect of CYP2C9 genotypes, VKORC1 haplotypes, age, and concomitant medications.
1164182|NCT00401414|B1|Baseline|Dosing Algorithm A|"Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Algorithm A was a dosing decision-tree that included both clinical and genetic factors. It was based upon optimal clinical practice at the Brigham and Women's Hospital's Anticoagulation Management Service as well as published literature that has utilised warfarin pharmacogenetics.~Doses were subsequently adjusted based on serial INR measurements."
1164216|NCT00401401|O1|Outcome|Zalutumumab 4 mg/kg|Zalutumumab 8 weekly infusions
1164217|NCT00401401|O4|Outcome|Zalutumumab 16 mg/kg|Zalutumumab 8 weekly infusions
1164183|NCT00401414|P3|Participant Flow|Dosing Algorithm C|Dosing Algorithm C was generated as an update of dosing Algorithm B and was based upon additional patient data, similar to what was described above for Algorithm B, from the prospective accrual of 203 patients in the CROWN trial. The major difference between Algorithm B and Algorithm C was an update of the half maximal inhibitory concentration (IC50) estimate for each VKORC1 haplotype in the model used to generate Algorithm B to reflect warfarin’s PD effect as evident in the acquired patient data. Simulations using Algorithm C were repeated using the clinical endpoints described above to derive the optimal starting warfarin doses and titration scheme that was tested prospectively in subsequent patients enrolled in the CROWN study.
1164184|NCT00401414|P2|Participant Flow|Dosing Algorithm B|Dosing Algorithm B was generated from an analysis of warfarin dose, INR, genetic factors, demographic factors and concomitant drug therapy from an initial prospective group of 74 patients treated using Algorithm A. Using these data, a mechanistic concentration-INR model was constructed to refine the estimates of the effect of CYP2C9 genotypes, VKORC1 haplotypes, age, and concomitant medications.
1164185|NCT00401414|P1|Participant Flow|Dosing Algorithm A|"Algorithm A was a dosing decision-tree that included both clinical and genetic factors. It was based upon optimal clinical practice at the Brigham and Women's Hospital's Anticoagulation Management Service as well as published literature that has utilised warfarin pharmacogenetics.~Doses were subsequently adjusted based on serial INR measurements."
1164186|NCT00401414|O3|Outcome|Dosing Algorithm C|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm C was generated as an update of dosing Algorithm B and was based upon additional patient data, similar to what was described above for Algorithm B, from the prospective accrual of 203 patients in the CROWN trial. The major difference between Algorithm B and Algorithm C was an update of the half maximal inhibitory concentration (IC50) estimate for each VKORC1 haplotype in the model used to generate Algorithm B to reflect warfarin's PD effect as evident in the acquired patient data.
1164187|NCT00401414|O2|Outcome|Dosing Algorithm B|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm B was generated from an analysis of warfarin dose, INR, genetic factors, demographic factors and concomitant drug therapy from an initial prospective group of 74 patients treated using Algorithm A. Using these data, a mechanistic concentration-INR model was constructed to refine the estimates of the effect of CYP2C9 genotypes, VKORC1 haplotypes, age, and concomitant medications.
1164188|NCT00401414|O1|Outcome|Dosing Algorithm A|"Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Algorithm A was a dosing decision-tree that included both clinical and genetic factors. It was based upon optimal clinical practice at the Brigham and Women's Hospital's Anticoagulation Management Service as well as published literature that has utilised warfarin pharmacogenetics.~Doses were subsequently adjusted based on serial INR measurements."
1164189|NCT00401414|O3|Outcome|Dosing Algorithm C|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm C was generated as an update of dosing Algorithm B and was based upon additional patient data, similar to what was described above for Algorithm B, from the prospective accrual of 203 patients in the CROWN trial. The major difference between Algorithm B and Algorithm C was an update of the half maximal inhibitory concentration (IC50) estimate for each VKORC1 haplotype in the model used to generate Algorithm B to reflect warfarin's PD effect as evident in the acquired patient data.
1164190|NCT00401414|O2|Outcome|Dosing Algorithm B|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm B was generated from an analysis of warfarin dose, INR, genetic factors, demographic factors and concomitant drug therapy from an initial prospective group of 74 patients treated using Algorithm A. Using these data, a mechanistic concentration-INR model was constructed to refine the estimates of the effect of CYP2C9 genotypes, VKORC1 haplotypes, age, and concomitant medications.
1164191|NCT00401414|O1|Outcome|Dosing Algorithm A|"Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Algorithm A was a dosing decision-tree that included both clinical and genetic factors. It was based upon optimal clinical practice at the Brigham and Women's Hospital's Anticoagulation Management Service as well as published literature that has utilised warfarin pharmacogenetics.~Doses were subsequently adjusted based on serial INR measurements."
1164218|NCT00401401|O3|Outcome|Zalutumumab 12 mg/kg|Zalutumumab 8 weekly infusions
1164219|NCT00401401|O2|Outcome|Zalutumumab 8 mg/kg|Zalutumumab 8 weeky infusions
1164220|NCT00401401|O1|Outcome|Zalutumumab 4 mg/kg|Zalutumumab 8 weekly infusions
1164221|NCT00401401|O4|Outcome|Zalutumumab 16 mg/kg|Zalutumumab 8 weekly infusions
1164222|NCT00401401|O3|Outcome|Zalutumumab 12 mg/kg|Zalutumumab 8 weekly infusions
1164223|NCT00401401|O2|Outcome|Zalutumumab 8 mg/kg|Zalutumumab 8 weeky infusions
1164224|NCT00401401|O1|Outcome|Zalutumumab 4 mg/kg|Zalutumumab 8 weekly infusions
1164192|NCT00401414|O3|Outcome|Dosing Algorithm C|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm C was generated as an update of dosing Algorithm B and was based upon additional patient data, similar to what was described above for Algorithm B, from the prospective accrual of 203 patients in the CROWN trial. The major difference between Algorithm B and Algorithm C was an update of the half maximal inhibitory concentration (IC50) estimate for each VKORC1 haplotype in the model used to generate Algorithm B to reflect warfarin's PD effect as evident in the acquired patient data.
1164193|NCT00401414|O2|Outcome|Dosing Algorithm B|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm B was generated from an analysis of warfarin dose, INR, genetic factors, demographic factors and concomitant drug therapy from an initial prospective group of 74 patients treated using Algorithm A. Using these data, a mechanistic concentration-INR model was constructed to refine the estimates of the effect of CYP2C9 genotypes, VKORC1 haplotypes, age, and concomitant medications.
1164194|NCT00401414|O1|Outcome|Dosing Algorithm A|"Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Algorithm A was a dosing decision-tree that included both clinical and genetic factors. It was based upon optimal clinical practice at the Brigham and Women's Hospital's Anticoagulation Management Service as well as published literature that has utilised warfarin pharmacogenetics.~Doses were subsequently adjusted based on serial INR measurements."
1164195|NCT00401414|O3|Outcome|Dosing Algorithm C|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm C was generated as an update of dosing Algorithm B and was based upon additional patient data, similar to what was described above for Algorithm B, from the prospective accrual of 203 patients in the CROWN trial. The major difference between Algorithm B and Algorithm C was an update of the half maximal inhibitory concentration (IC50) estimate for each VKORC1 haplotype in the model used to generate Algorithm B to reflect warfarin's PD effect as evident in the acquired patient data.
1164196|NCT00401414|O2|Outcome|Dosing Algorithm B|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm B was generated from an analysis of warfarin dose, INR, genetic factors, demographic factors and concomitant drug therapy from an initial prospective group of 74 patients treated using Algorithm A. Using these data, a mechanistic concentration-INR model was constructed to refine the estimates of the effect of CYP2C9 genotypes, VKORC1 haplotypes, age, and concomitant medications.
1164197|NCT00401414|O1|Outcome|Dosing Algorithm A|"Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Algorithm A was a dosing decision-tree that included both clinical and genetic factors. It was based upon optimal clinical practice at the Brigham and Women's Hospital's Anticoagulation Management Service as well as published literature that has utilised warfarin pharmacogenetics.~Doses were subsequently adjusted based on serial INR measurements."
1164198|NCT00401414|O3|Outcome|Dosing Algorithm C|
1164199|NCT00401414|O2|Outcome|Dosing Algorithm B|
1164200|NCT00401414|O1|Outcome|Dosing Algorithm A|"Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Algorithm A was a dosing decision-tree that included both clinical and genetic factors. It was based upon optimal clinical practice at the Brigham and Women's Hospital's Anticoagulation Management Service as well as published literature that has utilised warfarin pharmacogenetics.~Doses were subsequently adjusted based on serial INR measurements."
1164201|NCT00401414|E3|Reported Event|Dosing Algorithm C|
1164202|NCT00401414|E2|Reported Event|Dosing Algorithm B|
1164203|NCT00401414|E1|Reported Event|Dosing Algorithm A|
1164204|NCT00401401|B5|Baseline|Total|Total of all reporting groups
1164205|NCT00401401|B4|Baseline|Zalutumumab 16 mg/kg|Zalutumumab 8 weekly infusions
1164206|NCT00401401|B3|Baseline|Zalutumumab 12 mg/kg|Zalutumumab 8 weekly infusions
1164207|NCT00401401|B2|Baseline|Zalutumumab 8 mg/kg|Zalutumumab 8 weeky infusions
1164208|NCT00401401|B1|Baseline|Zalutumumab 4 mg/kg|Zalutumumab 8 weekly infusions
1164209|NCT00401401|P4|Participant Flow|Zalutumumab 16 mg/kg|Zalutumumab 8 weekly infusions
1164210|NCT00401401|P3|Participant Flow|Zalutumumab 12 mg/kg|Zalutumumab 8 weekly infusions
1164211|NCT00401401|P2|Participant Flow|Zalutumumab 8 mg/kg|Zalutumumab 8 weeky infusions
1164212|NCT00401401|P1|Participant Flow|Zalutumumab 4 mg/kg|Zalutumumab 8 weekly infusions
1164213|NCT00401401|O4|Outcome|Zalutumumab 16 mg/kg|Zalutumumab 8 weekly infusions
1164214|NCT00401401|O3|Outcome|Zalutumumab 12 mg/kg|Zalutumumab 8 weekly infusions
1164232|NCT00401401|E1|Reported Event|Zalutumumab 4 mg/kg|Zalutumumab 8 weekly infusions
1164233|NCT00401258|B1|Baseline|Duloxetine, 60 mg Daily|Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
1164234|NCT00401258|P1|Participant Flow|Duloxetine, 60 mg Daily|Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
1164235|NCT00401258|O1|Outcome|Duloxetine, 60 mg Daily|Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
1164236|NCT00401258|E1|Reported Event|Duloxetine, 60 mg Daily|Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
1164237|NCT00401245|B5|Baseline|Total|Total of all reporting groups
1164238|NCT00401245|B4|Baseline|DVS 100 mg, Then 100 mg|DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
1164239|NCT00401245|B3|Baseline|DVS 50 mg, Then 100 mg|DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase.
1164240|NCT00401245|B2|Baseline|DVS 25/50 mg, Then 100 mg|DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase.
1164241|NCT00401245|B1|Baseline|DVS 25 mg, Then 100 mg|DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
1164242|NCT00401245|P8|Participant Flow|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
1164243|NCT00401245|P7|Participant Flow|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
1164244|NCT00401245|P6|Participant Flow|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
1164245|NCT00401245|P5|Participant Flow|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally every other day (QOD) alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
1164246|NCT00401245|P4|Participant Flow|DVS 100 mg, Then 100 mg|DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
1164247|NCT00401245|P3|Participant Flow|DVS 50 mg, Then 100 mg|DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase.
1164248|NCT00401245|P2|Participant Flow|DVS 25/50 mg, Then 100 mg|DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase.
1164249|NCT00401245|P1|Participant Flow|DVS 25 mg, Then 100 mg|Desvenlafaxine succinate (DVS) 25 milligram (mg) tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week open label (OL) phase.
1164250|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
1164251|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
1164252|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
1164253|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
1164254|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
1164255|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
1164256|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
1164257|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
1164258|NCT00401245|O1|Outcome|DVS 100 mg|DVS 100 mg tablet taken orally daily for 15 weeks (OL phase).
1164259|NCT00401245|O1|Outcome|DVS 100 mg|DVS 100 mg tablet taken orally daily for 15 weeks (OL phase).
1164260|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
1164261|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
1164262|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
1164263|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
1164264|NCT00401245|O4|Outcome|DVS 100 mg, Then 100 mg|DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
1166193|NCT00395850|O4|Outcome|Disulfiram 500|Disulfiram at 500 mg/day
1164265|NCT00401245|O3|Outcome|DVS 50 mg, Then 100 mg|DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase.
1164266|NCT00401245|O2|Outcome|DVS 25/50 mg, Then 100 mg|DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase.
1164267|NCT00401245|O1|Outcome|DVS 25 mg, Then 100 mg|DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
1164268|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
1164269|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
1164270|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
1164271|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
1164272|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
1164273|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
1164274|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
1164275|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
1164276|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
1164277|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
1164278|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
1164279|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
1164280|NCT00401245|O4|Outcome|DVS 100 mg, Then 100 mg|DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
1164281|NCT00401245|O3|Outcome|DVS 50 mg, Then 100 mg|DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase.
1164282|NCT00401245|O2|Outcome|DVS 25/50 mg, Then 100 mg|DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase.
1164283|NCT00401245|O1|Outcome|DVS 25 mg, Then 100 mg|DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
1164284|NCT00401245|O4|Outcome|DVS 100 mg, Then 100 mg|DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
1164285|NCT00401245|O3|Outcome|DVS 50 mg, Then 100 mg|DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase.
1164286|NCT00401245|O2|Outcome|DVS 25/50 mg, Then 100 mg|DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase.
1164287|NCT00401245|O1|Outcome|DVS 25 mg, Then 100 mg|DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
1164288|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
1164289|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
1164290|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
1164291|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
1164292|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
1164293|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
1164294|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
1164295|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
1164334|NCT00401102|O1|Outcome|Group 1|All participants recieved Interpersonal psychotherapy
1164296|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
1164297|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
1164298|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
1164299|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
1164300|NCT00401245|O4|Outcome|DVS 100 mg, Then 100 mg|DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
1164301|NCT00401245|O3|Outcome|DVS 50 mg, Then 100 mg|DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase.
1164302|NCT00401245|O2|Outcome|DVS 25/50 mg, Then 100 mg|DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase.
1164303|NCT00401245|O1|Outcome|DVS 25 mg, Then 100 mg|DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
1164304|NCT00401245|E9|Reported Event|Placebo (Tapering Phase)|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
1164305|NCT00401245|E8|Reported Event|DVS 50 mg/Placebo (Tapering Phase)|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
1164306|NCT00401245|E7|Reported Event|DVS 50/25 mg (Tapering Phase)|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
1164307|NCT00401245|E6|Reported Event|DVS 50 mg QOD (Tapering Phase)|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
1164308|NCT00401245|E5|Reported Event|DVS 100 mg (OL Phase)|After 1 week of double blind titration phase, DVS 100 mg tablet taken orally daily for 15 weeks.
1164309|NCT00401245|E4|Reported Event|DVS 100 mg (Titration Phase)|DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase).
1164310|NCT00401245|E3|Reported Event|DVS 50 mg (Titration Phase)|DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase).
1164311|NCT00401245|E2|Reported Event|DVS 25/50 mg (Titration Phase)|DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase).
1164312|NCT00401245|E1|Reported Event|DVS 25 mg (Titration Phase)|DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase).
1164313|NCT00401193|B4|Baseline|Total|Total of all reporting groups
1164314|NCT00401193|B3|Baseline|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
1164315|NCT00401193|B2|Baseline|1950 mg/Day|One 650 mg Lysteda (tranexamic acid) tablet and one matching placebo tablet taken 3 times daily (1950 mg/day) for a maximum of 5 days during monthly menstruation
1164316|NCT00401193|B1|Baseline|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
1164317|NCT00401193|P3|Participant Flow|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
1164318|NCT00401193|P2|Participant Flow|1950 mg/Day|One 650 mg Lysteda (tranexamic acid) tablet and one matching placebo tablet taken 3 times daily (1950 mg/day) for a maximum of 5 days during monthly menstruation
1164319|NCT00401193|P1|Participant Flow|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
1164320|NCT00401193|O2|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
1164321|NCT00401193|O1|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
1164322|NCT00401193|O2|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
1164323|NCT00401193|O1|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
1164324|NCT00401193|O2|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
1164325|NCT00401193|O1|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
1164326|NCT00401193|O3|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
1164327|NCT00401193|O2|Outcome|1950 mg/Day|One 650 mg Lysteda (tranexamic acid) tablet and one matching placebo tablet taken 3 times daily (1950 mg/day) for a maximum of 5 days during monthly menstruation
1164328|NCT00401193|O1|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
1164329|NCT00401193|E3|Reported Event|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
1164330|NCT00401193|E2|Reported Event|1950 mg/Day|One 650 mg Lysteda (tranexamic acid) tablet and one matching placebo tablet taken 3 times daily (1950 mg/day) for a maximum of 5 days during monthly menstruation
1164331|NCT00401193|E1|Reported Event|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
1164332|NCT00401102|B1|Baseline|Group 1|All participants recieved Interpersonal psychotherapy
1164333|NCT00401102|P1|Participant Flow|Group 1|All participants recieved Interpersonal psychotherapy
1164335|NCT00401102|E1|Reported Event|Group 1|All participants recieved Interpersonal psychotherapy
1164336|NCT00400946|B6|Baseline|Total|Total of all reporting groups
1164337|NCT00400946|B5|Baseline|Expansion Cohort|Patients were enrolled in an expansion cohort to determine the prognostic significance of response to remission induction chemotherapy as measured by morphologic and minimal residual disease (MRD), and to further evaluate the efficacy of patients by final risk classification.
1164338|NCT00400946|B4|Baseline|Ineligible for Randomization|All patients received a single dose of intravenous PEG-asparaginase 2500 IU/m2 during multi-agent induction. Patients who did not achieve complete remission and were not assigned a final risk group by the end of the induction phase of treatment were not eligible for randomization. Patients who developed severe pancreatitis (defined as symptoms persisting for >72 h) during induction were not eligible for randomization and received no further doses of asparaginase. Patients who had hypersensitivity to intravenous PEG-asparaginase during induction were also ineligible for randomization, but received twice-weekly IM-EC (25 000 IU/m2) during the post-induction treatment phases.
1164339|NCT00400946|B3|Baseline|IM-EC [Directly Assigned]|Ph+ ALL patients did not participate in asparaginase randomization but were directly assigned to receive intramuscular E coli L-asparaginase during post-induction therapy. Patients who were eligible but declined randomization were also directly assigned to receive intramuscular E coli L-asparaginase.
1164340|NCT00400946|B2|Baseline|Intravenous PEG-asparaginase (IV-PEG)|Patients in this arm were randomized to intravenous PEG-asparaginase 2500 IU/m2 every 2 weeks for 15 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
1164341|NCT00400946|B1|Baseline|Intramuscular Native E Coli L-asparaginase (IM-EC)|Patients in this arm were randomized to intramuscular native E coli L-asparaginase 25 000 IU/m2 weekly for 30 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
1164342|NCT00400946|P5|Participant Flow|Expansion Cohort|Patients were enrolled in an expansion cohort to determine the prognostic significance of response to remission induction chemotherapy as measured by morphologic and minimal residual disease (MRD), and to further evaluate the efficacy of patients by final risk classification.
1164343|NCT00400946|P4|Participant Flow|Ineligible for Randomization|All patients received a single dose of intravenous PEG-asparaginase 2500 IU/m2 during multi-agent induction. Patients who did not achieve complete remission and were not assigned a final risk group by the end of the induction phase of treatment were not eligible for randomization. Patients who developed severe pancreatitis (defined as symptoms persisting for >72 h) during induction were not eligible for randomization and received no further doses of asparaginase. Patients who had hypersensitivity to intravenous PEG-asparaginase during induction were also ineligible for randomization, but received twice-weekly IM-EC (25 000 IU/m2) during the post-induction treatment phases.
1164344|NCT00400946|P3|Participant Flow|IM-EC [Directly Assigned]|Ph+ ALL patients did not participate in asparaginase randomization but were directly assigned to receive intramuscular E coli L-asparaginase during post-induction therapy. Patients who were eligible but declined randomization were also directly assigned to receive intramuscular E coli L-asparaginase.
1164345|NCT00400946|P2|Participant Flow|Intravenous PEG-asparaginase (IV-PEG)|Patients in this arm were randomized to intravenous PEG-asparaginase 2500 IU/m2 every 2 weeks for 15 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
1164346|NCT00400946|P1|Participant Flow|Intramuscular Native E Coli L-asparaginase (IM-EC)|Patients in this arm were randomized to intramuscular native E coli L-asparaginase 25 000 IU/m2 weekly for 30 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
1164347|NCT00400946|O5|Outcome|Traumatic Tap Without Blasts|Traumatic Tap without Blasts: without blast cells and >100 RBCs on a wet prep
1164348|NCT00400946|O4|Outcome|Traumatic Tap With Blasts|Traumatic Tap with Blasts: with blast cells and >100 RBCs on a wet prep
1164349|NCT00400946|O3|Outcome|CNS-3|CNS-3: more than 5 WBC on CSF cell count, with blasts on cytospin
1164350|NCT00400946|O2|Outcome|CNS-2|CNS-2: 5 or fewer WBC on CSF cell count, with blasts on cytospin
1164351|NCT00400946|O1|Outcome|CNS-1|CNS-1: no blast cells in cytospin, regardless of cerebrospinal fluid (CSF) count
1164352|NCT00400946|O3|Outcome|Hypocellular Day 18 Bone Marrow Status|Hypocellular marrow morphology at day 18 was defined as empty blasts.
1164353|NCT00400946|O2|Outcome|M2/M3 Day 18 Bone Marrow Status|M2 marrow morphology at day 18 was defined as 5-24% blasts. M3 marrow morphology at day 18 was defined as >25% blasts.
1164354|NCT00400946|O1|Outcome|M1 Day 18 Bone Marrow Status|M1 marrow morphology at day 18 was defined as <5% blasts.
1164355|NCT00400946|O2|Outcome|High Day 32 MRD Level|High end-induction (day 32) minimal residual disease (MRD) evaluated was defined as >/=0.001. This MRD classification was one component of determining final risk classification. Peripheral blood samples were collected for evaluation of MRD using PCR methods
1164356|NCT00400946|O1|Outcome|Low Day 32 MRD Level|Low end-induction (day 32) minimal residual disease (MRD) evaluated was defined as <0.001. This MRD classification was one component of determining final risk classification. Peripheral blood samples were collected for evaluation of MRD using PCR methods.
1164392|NCT00400803|O1|Outcome|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
1164875|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
1164357|NCT00400946|O1|Outcome|Overall|Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. All patients received a single dose of intravenous PEG-asparaginase 2500 IU/m2 during multi-agent induction. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization wherein patients received either E. coli L-asparaginase or peg-asparaginase. Standard risk and high-risk patients began post-induction randomized asparaginase therapy at the start of the CNS phase, whereas very high-risk patients began asparaginase therapy on day 8 of consolidation phase IC. Patients who did not achieve complete remission by the end of the induction phase were not eligible for randomization, were removed from protocol treatment, and received alternative therapy according to the discretion of their treating physician. Further details are provided in the study description section.
1164358|NCT00400946|O1|Outcome|Overall|Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. All patients received a single dose of intravenous PEG-asparaginase 2500 IU/m2 during multi-agent induction. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization wherein patients received either E. coli L-asparaginase or peg-asparaginase. Standard risk and high-risk patients began post-induction randomized asparaginase therapy at the start of the CNS phase, whereas very high-risk patients began asparaginase therapy on day 8 of consolidation phase IC. Patients who did not achieve complete remission by the end of the induction phase were not eligible for randomization, were removed from protocol treatment, and received alternative therapy according to the discretion of their treating physician. Further details are provided in the study description section.
1164359|NCT00400946|O1|Outcome|Overall|Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. All patients received a single dose of intravenous PEG-asparaginase 2500 IU/m2 during multi-agent induction. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization wherein patients received either E. coli L-asparaginase or peg-asparaginase. Standard risk and high-risk patients began post-induction randomized asparaginase therapy at the start of the CNS phase, whereas very high-risk patients began asparaginase therapy on day 8 of consolidation phase IC. Patients who did not achieve complete remission by the end of the induction phase were not eligible for randomization, were removed from protocol treatment, and received alternative therapy according to the discretion of their treating physician. Further details are provided in the study description section.
1164360|NCT00400946|O2|Outcome|Intravenous PEG-asparaginase (IV-PEG)|Patients in this arm were randomized to intravenous PEG-asparaginase 2500 IU/m2 every 2 weeks for 15 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
1164361|NCT00400946|O1|Outcome|Intramuscular Native E Coli L-asparaginase (IM-EC)|Patients in this arm were randomized to intramuscular native E coli L-asparaginase 25 000 IU/m2 weekly for 30 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
1164362|NCT00400946|O2|Outcome|Intravenous PEG-asparaginase (IV-PEG)|Patients in this arm were randomized to intravenous PEG-asparaginase 2500 IU/m2 every 2 weeks for 15 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
1164363|NCT00400946|O1|Outcome|Intramuscular Native E Coli L-asparaginase (IM-EC)|Patients in this arm were randomized to intramuscular native E coli L-asparaginase 25 000 IU/m2 weekly for 30 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
1164364|NCT00400946|O2|Outcome|Intravenous PEG-asparaginase (IV-PEG)|Patients in this arm were randomized to intravenous PEG-asparaginase 2500 IU/m2 every 2 weeks for 15 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
1164365|NCT00400946|O1|Outcome|Intramuscular Native E Coli L-asparaginase (IM-EC)|Patients in this arm were randomized to intramuscular native E coli L-asparaginase 25 000 IU/m2 weekly for 30 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
1164366|NCT00400946|O2|Outcome|Intravenous PEG-asparaginase (IV-PEG)|Patients in this arm were randomized to intravenous PEG-asparaginase 2500 IU/m2 every 2 weeks for 15 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
1164367|NCT00400946|O1|Outcome|Intramuscular Native E Coli L-asparaginase (IM-EC)|Patients in this arm were randomized to intramuscular native E coli L-asparaginase 25 000 IU/m2 weekly for 30 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
1164393|NCT00400803|O4|Outcome|Progressive Disease|At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).
1164604|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164876|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
1164368|NCT00400946|E3|Reported Event|Overall|Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. All patients received a single dose of intravenous PEG-asparaginase 2500 IU/m2 during multi-agent induction. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization wherein patients received either E. coli L-asparaginase or peg-asparaginase. Standard risk and high-risk patients began post-induction randomized asparaginase therapy at the start of the CNS phase, whereas very high-risk patients began asparaginase therapy on day 8 of consolidation phase IC. Patients who did not achieve complete remission by the end of the induction phase were not eligible for randomization, were removed from protocol treatment, and received alternative therapy according to the discretion of their treating physician. Further details are provided in the study description section.
1164369|NCT00400946|E2|Reported Event|Intravenous PEG-asparaginase (IV-PEG)|Patients in this arm were randomized to intravenous PEG-asparaginase 2500 IU/m2 every 2 weeks for 15 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
1164370|NCT00400946|E1|Reported Event|Intramuscular Native E Coli L-asparaginase (IM-EC)|Patients in this arm were randomized to intramuscular native E coli L-asparaginase 25 000 IU/m2 weekly for 30 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.
1164371|NCT00400881|B3|Baseline|Total|Total of all reporting groups
1164372|NCT00400881|B2|Baseline|Automatic Tube Compensation (ATC)|ATC mode of ventilation (intervention, not-standard mode)
1164373|NCT00400881|B1|Baseline|CPAP (Continuous Positive Airway Pressure)|CPAP (continuous positive airway pressure)(standard mode of ventilation, non-intervention control group)
1164374|NCT00400881|P2|Participant Flow|Automatic Tube Compensation (ATC)|ATC mode of ventilation (intervention, not-standard mode)
1164375|NCT00400881|P1|Participant Flow|CPAP (Continuous Positive Airway Pressure)|CPAP (continuous positive airway pressure)(standard mode of ventilation, non-intervention control group)
1164376|NCT00400881|O2|Outcome|ATC (AT Comp)|Automatic Tube Compensation
1164377|NCT00400881|O1|Outcome|CPAP|Continuous Positive Airway Pressure
1164378|NCT00400881|O2|Outcome|ATC (ATComp)|Automatic Tube Compensation
1164379|NCT00400881|O1|Outcome|CPAP|Continuous Positive Airway Pressure
1164380|NCT00400881|E2|Reported Event|Automatic Tube Compensation (ATC)|ATC mode of ventilation (intervention, not-standard mode)
1164381|NCT00400881|E1|Reported Event|CPAP (Continuous Positive Airway Pressure)|CPAP (continuous positive airway pressure)(standard mode of ventilation, non-intervention control group)
1164382|NCT00400829|B1|Baseline|Arm I|"Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~eribulin mesylate: Given IV"
1164383|NCT00400829|P1|Participant Flow|Arm I|"Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~eribulin mesylate: Given IV"
1164384|NCT00400829|O1|Outcome|Arm I|"Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~eribulin mesylate: Given IV"
1164385|NCT00400829|O1|Outcome|Arm I|"Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~eribulin mesylate: Given IV"
1164386|NCT00400829|O1|Outcome|Arm I|"Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~eribulin mesylate: Given IV"
1164387|NCT00400829|E1|Reported Event|Arm I|"Patients receive eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~eribulin mesylate: Given IV"
1164388|NCT00400803|B1|Baseline|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
1164389|NCT00400803|P1|Participant Flow|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
1164390|NCT00400803|O1|Outcome|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
1164391|NCT00400803|O1|Outcome|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
1164394|NCT00400803|O3|Outcome|Stable Disease|Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. To be assigned a status of stable disease, measurements must have met the stable disease criteria at least once after study entry at a minimum interval.
1166194|NCT00395850|O3|Outcome|Disulfiram 375|Disulfiram at 375 mg/day
1164395|NCT00400803|O2|Outcome|Partial Response|At least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. To be assigned a status of partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met.
1164396|NCT00400803|O1|Outcome|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine, Carboplatin and Avastin IV every 14 days.
1164397|NCT00400803|O1|Outcome|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
1164398|NCT00400803|E1|Reported Event|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
1164399|NCT00400764|B6|Baseline|Total|Total of all reporting groups
1164400|NCT00400764|B5|Baseline|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
1164401|NCT00400764|B4|Baseline|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
1164402|NCT00400764|B3|Baseline|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
1164403|NCT00400764|B2|Baseline|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
1164404|NCT00400764|B1|Baseline|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
1164405|NCT00400764|P5|Participant Flow|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
1164406|NCT00400764|P4|Participant Flow|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
1164407|NCT00400764|P3|Participant Flow|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
1164408|NCT00400764|P2|Participant Flow|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
1164409|NCT00400764|P1|Participant Flow|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
1164410|NCT00400764|O2|Outcome|Phase II Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants may also have received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
1164411|NCT00400764|O1|Outcome|Phase Ib Dulanermin|Participants received 4.0 mg/kg/day or 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
1164412|NCT00400764|O5|Outcome|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
1164413|NCT00400764|O4|Outcome|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
1164414|NCT00400764|O3|Outcome|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
1164415|NCT00400764|O2|Outcome|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
1164416|NCT00400764|O1|Outcome|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
1164417|NCT00400764|O5|Outcome|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
1164444|NCT00400764|O3|Outcome|Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
1164418|NCT00400764|O4|Outcome|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
1164419|NCT00400764|O3|Outcome|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
1164420|NCT00400764|O2|Outcome|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
1164421|NCT00400764|O1|Outcome|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
1164422|NCT00400764|O3|Outcome|Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
1164423|NCT00400764|O2|Outcome|Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
1164424|NCT00400764|O1|Outcome|Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
1164425|NCT00400764|O3|Outcome|Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
1164426|NCT00400764|O2|Outcome|Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
1164427|NCT00400764|O1|Outcome|Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
1164428|NCT00400764|O3|Outcome|Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
1164429|NCT00400764|O2|Outcome|Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
1164430|NCT00400764|O1|Outcome|Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
1164431|NCT00400764|O3|Outcome|Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
1164432|NCT00400764|O2|Outcome|Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
1164433|NCT00400764|O1|Outcome|Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
1164434|NCT00400764|O5|Outcome|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
1164435|NCT00400764|O4|Outcome|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
1164436|NCT00400764|O3|Outcome|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
1164437|NCT00400764|O2|Outcome|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
1164438|NCT00400764|O1|Outcome|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
1164439|NCT00400764|O5|Outcome|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
1164440|NCT00400764|O4|Outcome|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
1164441|NCT00400764|O3|Outcome|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
1164442|NCT00400764|O2|Outcome|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
1164443|NCT00400764|O1|Outcome|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
1164605|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164445|NCT00400764|O2|Outcome|Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
1164446|NCT00400764|O1|Outcome|Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
1164447|NCT00400764|O5|Outcome|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
1164448|NCT00400764|O4|Outcome|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
1164449|NCT00400764|O3|Outcome|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
1164450|NCT00400764|O2|Outcome|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
1164451|NCT00400764|O1|Outcome|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
1164452|NCT00400764|O2|Outcome|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
1164453|NCT00400764|O1|Outcome|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
1164454|NCT00400764|E5|Reported Event|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
1164455|NCT00400764|E4|Reported Event|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
1164456|NCT00400764|E3|Reported Event|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
1164457|NCT00400764|E2|Reported Event|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
1164458|NCT00400764|E1|Reported Event|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
1164459|NCT00400712|B3|Baseline|Total|Total of all reporting groups
1164460|NCT00400712|B2|Baseline|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)~physical rehabilitation: two weeks intensive physical rehabilitation"
1164461|NCT00400712|B1|Baseline|Control|natural progression post-stroke
1164462|NCT00400712|P2|Participant Flow|Intervention|two weeks of goal directed intensive physical rehabilitation therapy aimed at improving mobility at 6 months (and one year)
1164463|NCT00400712|P1|Participant Flow|Control|no intervention, natural history following stroke
1164464|NCT00400712|O2|Outcome|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)~physical rehabilitation: two weeks intensive physical rehabilitation"
1164465|NCT00400712|O1|Outcome|Control|natural progression post-stroke
1164466|NCT00400712|O2|Outcome|Intervention|two weeks of goal directed intensive physical rehabilitation therapy aimed at improving mobility at 6 months .
1164467|NCT00400712|O1|Outcome|Control|no intervention, natural progression post-stroke
1164468|NCT00400712|O2|Outcome|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)~physical rehabilitation: two weeks intensive physical rehabilitation"
1164469|NCT00400712|O1|Outcome|Control|natural progression post-stroke
1164470|NCT00400712|O2|Outcome|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)~physical rehabilitation: two weeks intensive physical rehabilitation"
1164471|NCT00400712|O1|Outcome|Control|natural progression post-stroke
1164472|NCT00400712|O2|Outcome|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)~physical rehabilitation: two weeks intensive physical rehabilitation"
1164473|NCT00400712|O1|Outcome|Control|natural progression post-stroke
1164474|NCT00400712|O2|Outcome|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)~physical rehabilitation: two weeks intensive physical rehabilitation"
1164475|NCT00400712|O1|Outcome|Control|natural progression post-stroke
1164476|NCT00400712|O2|Outcome|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)~physical rehabilitation: two weeks intensive physical rehabilitation"
1164477|NCT00400712|O1|Outcome|Control|natural progression post-stroke
1164478|NCT00400712|E2|Reported Event|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)~physical rehabilitation: two weeks intensive physical rehabilitation"
1164479|NCT00400712|E1|Reported Event|Control|natural progression post-stroke
1164480|NCT00400686|B1|Baseline|Epoetin Alfa - 80,000 U sc|"Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels~epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1."
1164481|NCT00400686|P1|Participant Flow|Epoetin Alfa - 80,000 U sc|"Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels~epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1."
1164482|NCT00400686|O1|Outcome|Epoetin Alfa - 80,000 U sc|"Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels~epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1."
1164483|NCT00400686|O1|Outcome|Epoetin Alfa - 80,000 U sc|"Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels~epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1."
1164484|NCT00400686|O1|Outcome|Epoetin Alfa - 80,000 U sc|"Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels~epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1."
1164485|NCT00400686|E1|Reported Event|Epoetin Alfa - 80,000 U sc|"Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels~epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1."
1164486|NCT00400634|B3|Baseline|Total|Total of all reporting groups
1164487|NCT00400634|B2|Baseline|Sham Surgery Control Group|Subjects who were randomized to undergo sham surgery (partial burr holes)
1164488|NCT00400634|B1|Baseline|CERE-120 Treatment Group|Subjects who were randomized to receive bilateral intraputaminal administration of CERE-120 (5.4 x 10^11 vg)
1164489|NCT00400634|P2|Participant Flow|Sham Surgery Control Group|Subjects who were randomized to undergo sham surgery (partial burr holes)
1164490|NCT00400634|P1|Participant Flow|CERE-120 Treatment Group|Subjects who were randomized to receive bilateral intraputaminal administration of CERE-120 (5.4 x 10^11 vg)
1164491|NCT00400634|O2|Outcome|Sham Surgery Control Group|Subjects who were randomized to undergo sham surgery (partial burr holes)
1164492|NCT00400634|O1|Outcome|CERE-120 Treatment Group|Subjects who were randomized to receive bilateral intraputaminal administration of CERE-120 (5.4 x 10^11 vg)
1164493|NCT00400634|O2|Outcome|Sham Surgery Control Group|Subjects who were randomized to undergo sham surgery (partial burr holes)
1164494|NCT00400634|O1|Outcome|CERE-120 Treatment Group|Subjects who were randomized to receive bilateral intraputaminal administration of CERE-120 (5.4 x 10^11 vg)
1164495|NCT00400634|E2|Reported Event|Sham Surgery Control Group|Subjects who were randomized to undergo sham surgery (partial burr holes)
1164496|NCT00400634|E1|Reported Event|CERE-120 Treatment Group|Subjects who were randomized to receive bilateral intraputaminal administration of CERE-120 (5.4 x 10^11 vg)
1164497|NCT00400569|B1|Baseline|Experimental: Sunitinib Malate (SU011248) Treatment|Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
1164498|NCT00400569|P1|Participant Flow|Experimental: Sunitinib Malate (SU011248) Treatment|Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
1164499|NCT00400569|O1|Outcome|Experimental: Sunitinib Malate (SU011248) Treatment|Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
1164500|NCT00400569|O3|Outcome|Malignant Fibrous Histiocytoma (MFH) Cohort Only|Experimental: Sunitinib Malate (SU011248) Treatment
1164501|NCT00400569|O2|Outcome|Leiomyosarcoma Cohort Only|Experimental: Sunitinib Malate (SU011248) Treatment
1164502|NCT00400569|O1|Outcome|Liposarcoma Cohort Only|Experimental: Sunitinib Malate (SU011248) Treatment
1164503|NCT00400569|O3|Outcome|Malignant Fibrous Histiocytoma (MFH) Cohort Only|Experimental: Sunitinib Malate (SU011248) Treatment
1164504|NCT00400569|O2|Outcome|Leiomyosarcoma Cohort Only|Experimental: Sunitinib Malate (SU011248) Treatment
1164505|NCT00400569|O1|Outcome|Liposarcoma Cohort Only|Experimental: Sunitinib Malate (SU011248) Treatment
1164506|NCT00400569|O1|Outcome|Experimental: Sunitinib Malate (SU011248) Treatment|Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
1164507|NCT00400569|E1|Reported Event|Experimental: Sunitinib Malate (SU011248) Treatment|Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
1164508|NCT00400400|B3|Baseline|Total|Total of all reporting groups
1164509|NCT00400400|B2|Baseline|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
1164510|NCT00400400|B1|Baseline|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
1164511|NCT00400400|P2|Participant Flow|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
1164512|NCT00400400|P1|Participant Flow|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
1166195|NCT00395850|O2|Outcome|Disulfiram 250|disulfiram at 250 mg/day
1164513|NCT00400400|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
1164514|NCT00400400|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
1164515|NCT00400400|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
1164516|NCT00400400|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
1164517|NCT00400400|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
1164518|NCT00400400|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
1164519|NCT00400400|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
1164520|NCT00400400|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
1164521|NCT00400400|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
1164522|NCT00400400|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
1164523|NCT00400400|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
1164524|NCT00400400|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
1164525|NCT00400400|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
1164526|NCT00400400|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
1164546|NCT00400179|O2|Outcome|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
1164527|NCT00400400|E2|Reported Event|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
1164528|NCT00400400|E1|Reported Event|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
1164529|NCT00400205|B1|Baseline|TPF Induction Therapy for Head and Neck Cancer|Patients with locally advanced squamous cell carcinoma of the head and neck received three cycles of induction therapy with TPF followed by local therapy consisting of surgical resection in addition to possible radiation therapy with or without concurrent chemotherapy.
1164530|NCT00400205|P1|Participant Flow|TPF Induction in Head and Neck Cancer|Phase II single arm study of TPF induction therapy in patients with head and neck cancer.
1164531|NCT00400205|O1|Outcome|TPF Induction in Head and Neck Cancer|Phase II single arm study of TPF induction therapy in patients with head and neck cancer.
1164532|NCT00400205|E1|Reported Event|TPF Induction Therapy for Head and Neck Cancer|Patients with locally advanced squamous cell carcinoma of the head and neck received three cycles of induction therapy with TPF followed by local therapy consisting of surgical resection in addition to possible radiation therapy with or without concurrent chemotherapy.
1164533|NCT00400179|B3|Baseline|Total|Total of all reporting groups
1164534|NCT00400179|B2|Baseline|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
1164535|NCT00400179|B1|Baseline|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.~Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
1164536|NCT00400179|P2|Participant Flow|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
1164537|NCT00400179|P1|Participant Flow|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.~Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
1164538|NCT00400179|O2|Outcome|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
1164539|NCT00400179|O1|Outcome|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.~Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
1164540|NCT00400179|O2|Outcome|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
1164541|NCT00400179|O1|Outcome|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.~Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
1164542|NCT00400179|O2|Outcome|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
1164543|NCT00400179|O1|Outcome|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.~Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
1164544|NCT00400179|O2|Outcome|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
1164545|NCT00400179|O1|Outcome|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.~Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
1164547|NCT00400179|O1|Outcome|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.~Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
1164548|NCT00400179|E2|Reported Event|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
1164549|NCT00400179|E1|Reported Event|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.~Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
1164550|NCT00400153|B4|Baseline|Total|Total of all reporting groups
1164551|NCT00400153|B3|Baseline|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164552|NCT00400153|B2|Baseline|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164553|NCT00400153|B1|Baseline|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164554|NCT00400153|P3|Participant Flow|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164555|NCT00400153|P2|Participant Flow|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164556|NCT00400153|P1|Participant Flow|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164557|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164558|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164559|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164560|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164561|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164562|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164563|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164564|NCT00400153|O3|Outcome|Ipratropium Respimat 20 Mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164565|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164566|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164567|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164568|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164569|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164570|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164571|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164572|NCT00400153|O1|Outcome|Number of Patients|Total number of patients due to rating of turning
1164573|NCT00400153|O1|Outcome|Number of Patients|Total number of patients due to device preference
1164574|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
1164575|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
1164576|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
1164577|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
1164578|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
1164579|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
1164580|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
1164581|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
1164582|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
1164583|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
1164584|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
1164585|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
1164586|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
1164587|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
1164588|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
1164589|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
1164590|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
1164591|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
1164592|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
1164593|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
1164594|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
1164595|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
1164596|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164597|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164598|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164599|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164600|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164601|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164602|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164603|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164606|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164607|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164608|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164609|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164610|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164611|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164612|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164613|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164614|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164615|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164616|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164617|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164618|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164619|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164620|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164621|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164622|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164623|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164624|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164625|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164626|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164627|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164628|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164629|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164630|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164631|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164632|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164633|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164634|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164635|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164636|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164637|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164638|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164639|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164640|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164641|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164642|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164643|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164644|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164645|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164646|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164647|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164648|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164649|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164650|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164651|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164652|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164653|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164654|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164655|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164656|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164657|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164658|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164659|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164660|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164661|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164662|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164663|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164664|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164665|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164666|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164667|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164668|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164669|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164670|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164671|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164672|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164673|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164674|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164675|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164676|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164677|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164678|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164679|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164680|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164681|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164682|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164683|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164684|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164685|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164686|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164687|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164688|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164689|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164690|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164691|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164692|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164693|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164694|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164695|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164696|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164697|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164698|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164699|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164700|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164701|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164702|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164703|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164704|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164705|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164706|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164707|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164708|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164709|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164710|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164711|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164712|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164713|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164714|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164715|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164716|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164717|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164718|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164719|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164720|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164721|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164722|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164723|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164724|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164725|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164726|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164727|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164728|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164729|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164730|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164731|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164732|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164733|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164734|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164735|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164736|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164737|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164738|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164739|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164740|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164741|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164742|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164743|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164744|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164745|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164746|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164747|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164748|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164749|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164750|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164751|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164752|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164753|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164754|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164755|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164756|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164757|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164758|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164759|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164760|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164761|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164762|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164763|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164764|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164765|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164766|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164767|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164768|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164769|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164770|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164771|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164772|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164773|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164774|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164775|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164776|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164777|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164778|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164779|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164780|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164781|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164782|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164783|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164784|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164785|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164786|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164787|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164788|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164789|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164790|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164791|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164792|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164793|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164794|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164795|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164796|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164797|NCT00400153|E3|Reported Event|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
1164798|NCT00400153|E2|Reported Event|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
1164799|NCT00400153|E1|Reported Event|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
1164800|NCT00399893|B3|Baseline|Total|Total of all reporting groups
1164801|NCT00399893|B2|Baseline|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
1164802|NCT00399893|B1|Baseline|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
1164803|NCT00399893|P2|Participant Flow|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
1164804|NCT00399893|P1|Participant Flow|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
1164805|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
1164806|NCT00399893|O1|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
1164807|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
1164808|NCT00399893|O1|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
1164809|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
1164810|NCT00399893|O1|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
1164811|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
1164812|NCT00399893|O1|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
1164813|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
1164814|NCT00399893|O1|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
1164815|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
1164816|NCT00399893|O1|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
1164817|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
1164818|NCT00399893|O1|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
1164819|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
1164820|NCT00399893|O1|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
1164821|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
1164822|NCT00399893|O1|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
1164823|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
1164824|NCT00399893|O1|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
1166196|NCT00395850|O1|Outcome|Placebo|microcrystalline cellulose
1164825|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
1164826|NCT00399893|O1|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
1164827|NCT00399893|E2|Reported Event|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
1164828|NCT00399893|E1|Reported Event|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
1164829|NCT00399763|B3|Baseline|Total|Total of all reporting groups
1164830|NCT00399763|B2|Baseline|Atomoxetine|The participants received atomoxetine for their ADHD and CBT for their substance use disorder. The atomoxetine was titrated to 100 mg daily unless participants were less then 70 kg. In that case, they were titrated to 1.2 mg/kg per day.
1164831|NCT00399763|B1|Baseline|Placebo|The participants received placebo plus CBT for their substance use disorder for 12 weeks.
1164832|NCT00399763|P2|Participant Flow|Atomoxetine|The participants received atomoxetine for their ADHD and CBT for their substance use disorder. The atomoxetine was titrated to 100 mg daily unless participants were less then 70 kg. In that case, they were titrated to 1.2 mg/kg per day.
1164833|NCT00399763|P1|Participant Flow|Placebo|The participants received placebo plus CBT for their substance use disorder for 12 weeks.
1164834|NCT00399763|O2|Outcome|Atomoxetine|The participants received atomoxetine for their ADHD and CBT for their substance use disorder. The atomoxetine was titrated to 100 mg daily unless participants were less then 70 kg. In that case, they were titrated to 1.2 mg/kg per day.
1164835|NCT00399763|O1|Outcome|Placebo|The participants received placebo plus CBT for their substance use disorder for 12 weeks.
1164836|NCT00399763|O2|Outcome|Atomoxetine|The participants received atomoxetine for their ADHD and CBT for their substance use disorder. The atomoxetine was titrated to 100 mg daily unless participants were less then 70 kg. In that case, they were titrated to 1.2 mg/kg per day.
1164837|NCT00399763|O1|Outcome|Placebo|The participants received placebo plus CBT for their substance use disorder for 12 weeks.
1164838|NCT00399763|O2|Outcome|Atomoxetine|The participants received atomoxetine for their ADHD and CBT for their substance use disorder. The atomoxetine was titrated to 100 mg daily unless participants were less then 70 kg. In that case, they were titrated to 1.2 mg/kg per day.
1164839|NCT00399763|O1|Outcome|Placebo|The participants received placebo plus CBT for their substance use disorder for 12 weeks.
1164840|NCT00399763|E2|Reported Event|Atomoxetine|The participants received atomoxetine for their ADHD and CBT for their substance use disorder. The atomoxetine was titrated to 100 mg daily unless participants were less then 70 kg. In that case, they were titrated to 1.2 mg/kg per day.
1164841|NCT00399763|E1|Reported Event|Placebo|The participants received placebo plus CBT for their substance use disorder for 12 weeks.
1164842|NCT00399568|B3|Baseline|Total|Total of all reporting groups
1164843|NCT00399568|B2|Baseline|IV Placebo 100 mL Solution|All subjects randomized to receive Intravenous (IV) placebo 100 mL solution every 6 hours for 48 hours for a total of 8 doses.
1164844|NCT00399568|B1|Baseline|IV Acetaminophen 1 g/100 mL Solution|All subjects randomized to receive Intravenous (IV) Acetaminophen 1 g/100 mL solution every 6 hours for 48 hours for a total of 8 doses.
1164845|NCT00399568|P2|Participant Flow|IV Placebo 100 mL Solution|All subjects randomized to receive Intravenous (IV) placebo 100 mL solution every 6 hours for 48 hours for a total of 8 doses.
1164846|NCT00399568|P1|Participant Flow|IV Acetaminophen 1 g/100 mL Solution|All subjects randomized to receive Intravenous (IV) Acetaminophen 1 g/100 mL solution every 6 hours for 48 hours for a total of 8 doses.
1164847|NCT00399568|O2|Outcome|IV Placebo 100 ml Solution|mITT Population IV Placebo 100 ml solution
1164848|NCT00399568|O1|Outcome|IV Acetaminophen 1 g/100 ml Solution|mITT Population IV acetaminophen 1 g/100 ml Solution
1164849|NCT00399568|O2|Outcome|IV Placebo 100 ml Solution|mITT Population IV Placebo 100 ml solution
1164850|NCT00399568|O1|Outcome|IV Acetaminophen 1 g/100 ml Solution|mITT Population IV acetaminophen 1 g/100 ml Solution
1164851|NCT00399568|O2|Outcome|IV Placebo 100 ml Solution|Safety Population(defined as those subjects who received any portion of a dose of IV Placebo 100 ml solution)
1164852|NCT00399568|O1|Outcome|IV Acetaminophen 1g/100 ml Solution|Safety Population (defined as those subjects who received any portion of a dose of IV acetaminophen 1g/100 ml solution)
1164853|NCT00399568|O2|Outcome|IV Placebo 100 ml Solution|mITT Population IV Placebo 100 ml solution
1164854|NCT00399568|O1|Outcome|IV Acetaminophen 1 g/100 ml Solution|mITT Population IV acetaminophen 1 g/100 ml Solution
1164855|NCT00399568|E2|Reported Event|IV Placebo 100 mL Solution|Safety Population (defined as those subjects who received any portion of a dose of IV Placebo 100 mL solution)
1164856|NCT00399568|E1|Reported Event|IV Acetaminophen 1g/100 mL Solution|Safety Population (defined as those subjects who received any portion of a dose of IV acetaminophen 1g/100 mL solution)
1164857|NCT00399542|B3|Baseline|Total|Total of all reporting groups
1164858|NCT00399542|B2|Baseline|Placebo|Subjects who received placebo
1164859|NCT00399542|B1|Baseline|Lubiprostone|Subjects who received active drug
1164860|NCT00399542|P2|Participant Flow|Placebo|Subjects who received placebo
1164861|NCT00399542|P1|Participant Flow|Lubiprostone|Subjects who received active drug
1164862|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
1164863|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
1164864|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
1164865|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
1164866|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
1164867|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
1164868|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
1164869|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
1164870|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
1164871|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
1164872|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
1164873|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
1164874|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
1164877|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
1164878|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
1164879|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
1164880|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
1164881|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
1164882|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
1164883|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
1164884|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
1164885|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
1164886|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
1164887|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
1164888|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
1164889|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
1164890|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
1164891|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
1164892|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
1164893|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
1164894|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
1164895|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
1164896|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
1164897|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
1164898|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
1164899|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
1164900|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
1164901|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
1164902|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
1164903|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
1164904|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
1164905|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
1164906|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
1164907|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
1164908|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
1164909|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
1164910|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
1164911|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
1164912|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
1164913|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
1164914|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
1164915|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
1164916|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
1164917|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
1164918|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
1164919|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
1164920|NCT00399542|E2|Reported Event|Placebo|Subjects who received placebo
1164921|NCT00399542|E1|Reported Event|Lubiprostone|Subjects who received active drug
1164922|NCT00399516|B1|Baseline|Spinal Cord Stimulation Programming Parameters|Spinal Cord Stimulation (SCS) Treatment Group
1164923|NCT00399516|P1|Participant Flow|Spinal Cord Stimulation Programming Parameters|Spinal Cord Stimulation (SCS) treatment group programmed using a randomly assigned sequence of stimulation parameters (i.e. pulse widths)
1164924|NCT00399516|O1|Outcome|Spinal Cord Stimulation Programming Parameters|Spinal Cord Stimulation (SCS) treatment group programmed using a randomly assigned sequence of stimulation parameters (i.e. pulse widths)
1164925|NCT00399516|E1|Reported Event|Spinal Cord Stimulation Programming Parameters|Spinal Cord Stimulation (SCS) Treatment Group
1164926|NCT00399360|B5|Baseline|Total|Total of all reporting groups
1164927|NCT00399360|B4|Baseline|Lifestyle Modification and Metformin|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
1164928|NCT00399360|B3|Baseline|No Lifestyle Modification and Metformin|Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
1164929|NCT00399360|B2|Baseline|Lifestyle Modification and Placebo|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
1164930|NCT00399360|B1|Baseline|No Lifestyle Modification and Placebo|Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
1164931|NCT00399360|P4|Participant Flow|Lifestyle Modification and Metformin|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
1164932|NCT00399360|P3|Participant Flow|No Lifestyle Modification and Metformin|Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
1164933|NCT00399360|P2|Participant Flow|Lifestyle Modification and Placebo|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
1165047|NCT00398411|P1|Participant Flow|Moxifloxacin|moxifloxacin 400 mg tablets once daily
1164934|NCT00399360|P1|Participant Flow|No Lifestyle Modification and Placebo|Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
1164935|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|
1164936|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|
1164937|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|
1164938|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.
1164939|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
1164940|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
1164941|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
1164942|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
1164943|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|
1164944|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|
1164945|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|
1164946|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.
1164947|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|
1164948|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|
1164949|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|
1164950|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.
1164951|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|
1164952|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|
1164953|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|
1164954|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|
1164955|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|
1164956|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|
1164957|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|
1164958|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.
1164959|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|
1164960|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|
1164961|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|
1164962|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.
1164963|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
1164964|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
1164965|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
1164966|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
1164967|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
1164968|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
1164969|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
1164970|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
1165048|NCT00398411|O2|Outcome|Placebo|identical appearing placebo
1165049|NCT00398411|O1|Outcome|Moxifloxacin|moxifloxacin 400 mg tablets once daily
1164971|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
1164972|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
1164973|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
1164974|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
1164975|NCT00399360|E4|Reported Event|Lifestyle Modification and Metformin|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
1164976|NCT00399360|E3|Reported Event|No Lifestyle Modification and Metformin|Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
1164977|NCT00399360|E2|Reported Event|Lifestyle Modification and Placebo|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
1164978|NCT00399360|E1|Reported Event|No Lifestyle Modification and Placebo|Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
1164979|NCT00399308|B4|Baseline|Total|Total of all reporting groups
1164980|NCT00399308|B3|Baseline|Group III - Control|Adaptic and Profore four-layer compression dressing
1164981|NCT00399308|B2|Baseline|Group II - Bi-weekly Celaderm|Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
1164982|NCT00399308|B1|Baseline|Group I - Weekly Celaderm|Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
1164983|NCT00399308|P3|Participant Flow|Group III - Control|Adaptic and Profore four-layer compression dressing
1164984|NCT00399308|P2|Participant Flow|Group II - Bi-weekly Celaderm|Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
1164985|NCT00399308|P1|Participant Flow|Group I - Weekly Celaderm|Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
1164986|NCT00399308|O3|Outcome|Group III - Control|Adaptic and Profore four-layer compression dressing
1164987|NCT00399308|O2|Outcome|Group II - Bi-weekly Celaderm|Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
1164988|NCT00399308|O1|Outcome|Group I - Weekly Celaderm|Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
1164989|NCT00399308|O3|Outcome|Group III - Control|Adaptic and Profore four-layer compression dressing
1164990|NCT00399308|O2|Outcome|Group II - Bi-weekly Celaderm|Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
1164991|NCT00399308|O1|Outcome|Group I - Weekly Celaderm|Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
1164992|NCT00399308|O3|Outcome|Group III - Control|Adaptic and Profore four-layer compression dressing
1164993|NCT00399308|O2|Outcome|Group II - Bi-weekly Celaderm|Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
1164994|NCT00399308|O1|Outcome|Group I - Weekly Celaderm|Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
1164995|NCT00399308|O3|Outcome|Group III - Control|Adaptic and Profore four-layer compression dressing
1164996|NCT00399308|O2|Outcome|Group II - Bi-weekly Celaderm|Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
1164997|NCT00399308|O1|Outcome|Group I - Weekly Celaderm|Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
1164998|NCT00399308|E3|Reported Event|Group III - Control|Adaptic and Profore four-layer compression dressing
1164999|NCT00399308|E2|Reported Event|Group II - Bi-weekly Celaderm|Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
1165000|NCT00399308|E1|Reported Event|Group I - Weekly Celaderm|Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
1165001|NCT00399035|B4|Baseline|Total|Total of all reporting groups
1165002|NCT00399035|B3|Baseline|Cediranib 30 mg|Cediranib 30 mg/day + FOLFOX/XELOX
1165003|NCT00399035|B2|Baseline|Placebo|Placebo + FOLFOX/XELOX
1165004|NCT00399035|B1|Baseline|Cediranib 20 mg|Cediranib 20 mg + FOLFOX/XELOX
1165042|NCT00398632|E1|Reported Event|Duloxetine|"Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression)~Duloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. duration: 12 weeks"
1165043|NCT00398411|B3|Baseline|Total|Total of all reporting groups
1165044|NCT00398411|B2|Baseline|Placebo|identical appearing placebo
1165005|NCT00399035|P3|Participant Flow|Placebo|[Placebo +FOLFOX/XELOX].2 FOLFOX regimens were chosen:FOLFOX4 or mFOLFOX6(repeated every 2 weeks.FOLFOX4:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 200mg/m2(or equivalent folinic acid preparation) by iv infusion over 2h on Day1 and Day2;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1 and Day2;5-FU 600 mg/m2 immediately after the 5-FU bolus dosed by continuous iv infusion over 22h on Day1 and Day2.mFOLFOX6:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 400mg/m2(or equivalent folinic acid preparation)dosed iv over 2h on Day1;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1,followed immediately by 5-FU 2400mg/m2 dosed by continuous iv infusion over 46h.XELOX:The XELOX regimen was to be repeated every 3 weeks:oxaliplatin 130mg/m2 dosed by iv infusion over 2h on Day1;capecitabine 1000mg/m2 orally twice daily on Days1 to 14.
1165006|NCT00399035|P2|Participant Flow|Cediranib 30 mg/Day|[Cediranib 30mg/day+FOLFOX/XELOX].2 FOLFOX regimens were chosen:FOLFOX4 or mFOLFOX6(repeated every 2 weeks.FOLFOX4:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 200mg/m2(or equivalent folinic acid preparation) by iv infusion over 2h on Day1 and Day2;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1 and Day2;5-FU 600 mg/m2 immediately after the 5-FU bolus dosed by continuous iv infusion over 22h on Day1 and Day2.mFOLFOX6:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 400mg/m2(or equivalent folinic acid preparation)dosed iv over 2h on Day1;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1,followed immediately by 5-FU 2400mg/m2 dosed by continuous iv infusion over 46h.XELOX:The XELOX regimen was to be repeated every 3 weeks:oxaliplatin 130mg/m2 dosed by iv infusion over 2h on Day1;capecitabine 1000mg/m2 orally twice daily on Days1 to 14.
1165007|NCT00399035|P1|Participant Flow|Cediranib 20 mg/Day|[Cediranib 20mg/day+FOLFOX/XELOX].2 FOLFOX regimens were chosen:FOLFOX4 or mFOLFOX6(repeated every 2 weeks.FOLFOX4:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 200mg/m2(or equivalent folinic acid preparation) by iv infusion over 2h on Day1 and Day2;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1 and Day2;5-FU 600 mg/m2 immediately after the 5-FU bolus dosed by continuous iv infusion over 22h on Day1 and Day2.mFOLFOX6:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 400mg/m2(or equivalent folinic acid preparation)dosed iv over 2h on Day1;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1,followed immediately by 5-FU 2400mg/m2 dosed by continuous iv infusion over 46h.XELOX:The XELOX regimen was to be repeated every 3 weeks:oxaliplatin 130mg/m2 dosed by iv infusion over 2h on Day1;capecitabine 1000mg/m2 orally twice daily on Days1 to 14.
1165008|NCT00399035|O2|Outcome|Placebo|Placebo + FOLFOX/XELOX
1165009|NCT00399035|O1|Outcome|Cediranib 20 mg|Cediranib 20 mg/day + FOLFOX/XELOX
1165010|NCT00399035|O2|Outcome|Placebo|Placebo + FOLFOX/XELOX
1165011|NCT00399035|O1|Outcome|Cediranib 20 mg|Cediranib 20 mg/day + FOLFOX/XELOX
1165012|NCT00399035|O2|Outcome|Placebo|Placebo + FOLFOX/XELOX
1165013|NCT00399035|O1|Outcome|Cediranib 20 mg|Cediranib 20 mg/day + FOLFOX/XELOX
1165014|NCT00399035|O2|Outcome|Placebo|Placebo + FOLFOX/XELOX
1165015|NCT00399035|O1|Outcome|Cediranib 20 mg|Cediranib 20 mg/day + FOLFOX/XELOX
1165016|NCT00399035|O2|Outcome|Placebo|Placebo + FOLFOX/XELOX
1165017|NCT00399035|O1|Outcome|Cediranib 20 mg|Cediranib 20 mg/day + FOLFOX/XELOX
1165018|NCT00399035|O2|Outcome|Placebo|Placebo + FOLFOX/XELOX
1165019|NCT00399035|O1|Outcome|Cediranib 20 mg|Cediranib 20 mg/day + FOLFOX/XELOX
1165020|NCT00399035|O2|Outcome|Placebo|Placebo + FOLFOX/XELOX
1165021|NCT00399035|O1|Outcome|Cediranib 20 mg|Cediranib 20 mg/day + FOLFOX/XELOX
1165022|NCT00399035|E3|Reported Event|Placebo|Placebo + Folfox/Xelox
1165023|NCT00399035|E2|Reported Event|Cediranib 20mg|Cediranib 20mg/day + Folfox/Xelox
1165024|NCT00399035|E1|Reported Event|Cediranib 30mg|Cediranib 30mg/day + Folfox/Xelox
1165025|NCT00398983|B3|Baseline|Total|Total of all reporting groups
1165026|NCT00398983|B2|Baseline|No Study Drug|Continue current therapy.
1165027|NCT00398983|B1|Baseline|Decitabine 20 mg/m^2|20 mg/m^2 intravenous (IV) daily for 5 days
1165028|NCT00398983|P2|Participant Flow|No Study Drug|Continue current therapy.
1165029|NCT00398983|P1|Participant Flow|Decitabine 20 mg/m^2|20 mg/m^2 intravenous (IV) daily for 5 days
1165030|NCT00398983|O2|Outcome|No Study Drug|Continue current therapy.
1165031|NCT00398983|O1|Outcome|Decitabine 20 mg/m^2|20 mg/m^2 intravenous (IV) daily for 5 days
1165032|NCT00398983|E2|Reported Event|No Study Drug|Continue current therapy.
1165033|NCT00398983|E1|Reported Event|Decitabine 20 mg/m^2|20 mg/m^2 intravenous (IV) daily for 5 days
1165034|NCT00398918|B1|Baseline|Zonisamide-Placebo Sessions|In this within subjects study, subjects received zonisamide in one session and placebo in a second
1165035|NCT00398918|P1|Participant Flow|Zonisamide-Placebo Sessions|In this within subjects study, subjects received zonisamide in one session and placebo in a second
1165036|NCT00398918|O1|Outcome|Zonisamide-Placebo Sessions|In this within subjects study, subjects received zonisamide in one session and placebo in a second
1165037|NCT00398918|O1|Outcome|Zonisamide-Placebo Sessions|In this within subjects study, subjects received zonisamide in one session and placebo in a second
1165038|NCT00398918|E1|Reported Event|Zonisamide-Placebo Sessions|In this within subjects study, subjects received zonisamide in one session and placebo in a second
1165039|NCT00398632|B1|Baseline|Duloxetine|Duloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. study duration: 12 weeks
1165040|NCT00398632|P1|Participant Flow|Duloxetine|"Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression)~Duloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. duration: 12 weeks"
1165041|NCT00398632|O1|Outcome|Duloxetine|"Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression)~Duloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. duration: 12 weeks"
1165045|NCT00398411|B1|Baseline|Moxifloxacin|moxifloxacin 400 mg tablets once daily
1165046|NCT00398411|P2|Participant Flow|Placebo|identical appearing placebo
1165051|NCT00398411|O1|Outcome|Moxifloxacin|moxifloxacin 400 mg tablets once daily
1165052|NCT00398411|O2|Outcome|Placebo|identical appearing placebo
1165053|NCT00398411|O1|Outcome|Moxifloxacin|moxifloxacin 400 mg tablets once daily
1165054|NCT00398411|O2|Outcome|Placebo|identical appearing placebo
1165055|NCT00398411|O1|Outcome|Moxifloxacin|moxifloxacin 400 mg tablets once daily
1165056|NCT00398411|O2|Outcome|Placebo|identical appearing placebo
1165057|NCT00398411|O1|Outcome|Moxifloxacin|moxifloxacin 400 mg tablets once daily
1165058|NCT00398411|O2|Outcome|Placebo|identical appearing placebo
1165059|NCT00398411|O1|Outcome|Moxifloxacin|moxifloxacin 400 mg tablets once daily
1165060|NCT00398411|E2|Reported Event|Placebo|identical appearing placebo
1165061|NCT00398411|E1|Reported Event|Moxifloxacin|moxifloxacin 400 mg tablets once daily
1165062|NCT00398398|B1|Baseline|Xelox Plus Cetuximab|Capecitabine, oxaliplatin and cetuximab
1165063|NCT00398398|P1|Participant Flow|Xelox Plus Cetuximab|"Capecitabine, oxaliplatin and cetuximab~cetuximab : initial loading dose of 400 mg/m2, maintenance dose of 250 mg/m2 (every week) Oxaliplatin : 130 mg/m2 (every 3 weeks) capecitabine :1,000 mg/m2 (days 1–14)"
1165064|NCT00398398|O1|Outcome|Xelox Plus Cetuximab|Capecitabine, oxaliplatin and cetuximab
1165065|NCT00398398|O1|Outcome|Xelox Plus Cetuximab|Capecitabine, oxaliplatin and cetuximab
1165066|NCT00398398|O1|Outcome|Xelox Plus Cetuximab|Capecitabine, oxaliplatin and cetuximab
1165067|NCT00398398|O1|Outcome|Xelox Plus Cetuximab|Capecitabine, oxaliplatin and cetuximab
1165068|NCT00398398|E1|Reported Event|Xelox Plus Cetuximab|Capecitabine, oxaliplatin and cetuximab
1165069|NCT00398320|B1|Baseline|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle~Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle~Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle~AEs reported are related and grade 3 or higher per CTCAE version 3."
1165070|NCT00398320|P1|Participant Flow|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle~Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle~Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle~Adverse events (AEs) reported are related and grade 3 or higher per CTCAE version 3."
1165071|NCT00398320|O1|Outcome|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle~Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle~Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle~AEs reported are related and grade 3 or higher per CTCAE version 3."
1165072|NCT00398320|O1|Outcome|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle~Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle~Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle~AEs reported are related and grade 3 or higher per CTCAE version 3."
1165073|NCT00398320|O1|Outcome|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle~Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle~Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle~AEs reported are related and grade 3 or higher per CTCAE version 3."
1165074|NCT00398320|O1|Outcome|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle~Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle~Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle~AEs reported are related and grade 3 or higher per CTCAE version 3."
1165075|NCT00398320|O1|Outcome|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle~Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle~Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle~AEs reported are related and grade 3 or higher per CTCAE version 3."
1165076|NCT00398320|E1|Reported Event|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21-day cycle~Capecitabine: 850 mg/m2 by mouth twice a day for days 1 to 14 on a 21-day cycle~Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21-day cycle~AEs reported are related and grade 3 or higher per CTCAE version 3."
1165077|NCT00398216|B6|Baseline|Total|Total of all reporting groups
1165078|NCT00398216|B5|Baseline|Dalteparin|dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
1165079|NCT00398216|B4|Baseline|Edoxaban 90mg QD|edoxaban 90mg QD PO
1165080|NCT00398216|B3|Baseline|Edoxaban 60mg QD|edoxaban 60mg QD PO
1165081|NCT00398216|B2|Baseline|Edoxaban 30mg QD|edoxaban 30mg QD PO
1165082|NCT00398216|B1|Baseline|Edoxaban 15mg QD|edoxaban 15mg QD (once daily) orally (PO)
1165083|NCT00398216|P5|Participant Flow|Dalteparin|dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
1165084|NCT00398216|P4|Participant Flow|Edoxaban 90mg QD|edoxaban 90mg QD PO
1165085|NCT00398216|P3|Participant Flow|Edoxaban 60mg QD|edoxaban 60mg QD PO
1165086|NCT00398216|P2|Participant Flow|Edoxaban 30mg QD|edoxaban 30mg QD PO
1165087|NCT00398216|P1|Participant Flow|Edoxaban 15mg QD|edoxaban 15mg QD (once daily) orally (PO)
1165088|NCT00398216|O5|Outcome|Dalteparin|dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
1165089|NCT00398216|O4|Outcome|Edoxaban 90mg QD|edoxaban 90mg QD PO
1165090|NCT00398216|O3|Outcome|Edoxaban 60mg QD|edoxaban 60mg QD PO
1165091|NCT00398216|O2|Outcome|Edoxaban 30mg QD|edoxaban 30mg QD PO
1165092|NCT00398216|O1|Outcome|Edoxaban 15mg QD|edoxaban 15mg QD (once daily) orally (PO)
1165093|NCT00398216|O5|Outcome|Dalteparin|dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
1165094|NCT00398216|O4|Outcome|Edoxaban 90mg QD|edoxaban 90mg QD PO
1165095|NCT00398216|O3|Outcome|Edoxaban 60mg QD|edoxaban 60mg QD PO
1165096|NCT00398216|O2|Outcome|Edoxaban 30mg QD|edoxaban 30mg QD PO
1165097|NCT00398216|O1|Outcome|Edoxaban 15mg QD|edoxaban 15mg QD (once daily) orally (PO)
1165098|NCT00398216|O5|Outcome|Dalteparin|dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
1165099|NCT00398216|O4|Outcome|Edoxaban 90mg QD|edoxaban 90mg QD PO
1165100|NCT00398216|O3|Outcome|Edoxaban 60mg QD|edoxaban 60mg QD PO
1165101|NCT00398216|O2|Outcome|Edoxaban 30mg QD|edoxaban 30mg QD PO
1165102|NCT00398216|O1|Outcome|Edoxaban 15mg QD|edoxaban 15mg QD (once daily) orally (PO)
1165103|NCT00398216|O5|Outcome|Dalteparin|dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
1165104|NCT00398216|O4|Outcome|Edoxaban 90mg QD|edoxaban 90mg QD PO
1165105|NCT00398216|O3|Outcome|Edoxaban 60mg QD|edoxaban 60mg QD PO
1165106|NCT00398216|O2|Outcome|Edoxaban 30mg QD|edoxaban 30mg QD PO
1165107|NCT00398216|O1|Outcome|Edoxaban 15mg QD|edoxaban 15mg QD (once daily) orally (PO)
1165108|NCT00398216|E5|Reported Event|Dalteparin|dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
1165109|NCT00398216|E4|Reported Event|Edoxaban 90mg QD|edoxaban 90mg QD PO
1165110|NCT00398216|E3|Reported Event|Edoxaban 60mg QD|edoxaban 60mg QD PO
1165111|NCT00398216|E2|Reported Event|Edoxaban 30mg QD|edoxaban 30mg QD PO
1165112|NCT00398216|E1|Reported Event|Edoxaban 15mg QD|edoxaban 15mg QD (once daily) orally (PO)
1165113|NCT00398138|B1|Baseline|Vaccine|"Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 & 12. Vaccinations will be administered subcutaneously with sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 & -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration. Patients will keep a logbook noting the time & placement of the injection. Note: during each vaccination, the Sargramostim (GM-CSF) & the vaccine emulsion will be administered to the same anatomical site. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. For patients who have a clinical, molecular, or immunologic response & have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.~WT-1 analog peptide vaccine"
1165114|NCT00398138|P1|Participant Flow|Vaccine|"Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 & 12. Vaccinations will be administered subcutaneously with sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 & -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration. Patients will keep a logbook noting the time & placement of the injection. Note: during each vaccination, the Sargramostim (GM-CSF) & the vaccine emulsion will be administered to the same anatomical site. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. For patients who have a clinical, molecular, or immunologic response & have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.~WT-1 analog peptide vaccine"
1165115|NCT00398138|O1|Outcome|Vaccine|"Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 & 12. Vaccinations will be administered subcutaneously with sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 & -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration. Patients will keep a logbook noting the time & placement of the injection. Note: during each vaccination, the Sargramostim (GM-CSF) & the vaccine emulsion will be administered to the same anatomical site. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. For patients who have a clinical, molecular, or immunologic response & have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.~WT-1 analog peptide vaccine"
1165116|NCT00398138|O1|Outcome|Vaccine|"Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 & 12. Vaccinations will be administered subcutaneously with sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 & -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration. Patients will keep a logbook noting the time & placement of the injection. Note: during each vaccination, the Sargramostim (GM-CSF) & the vaccine emulsion will be administered to the same anatomical site. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. For patients who have a clinical, molecular, or immunologic response & have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.~WT-1 analog peptide vaccine"
1165117|NCT00398138|E1|Reported Event|Vaccine|"Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 & 12. Vaccinations will be administered subcutaneously with sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 & -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration. Patients will keep a logbook noting the time & placement of the injection. Note: during each vaccination, the Sargramostim (GM-CSF) & the vaccine emulsion will be administered to the same anatomical site. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. For patients who have a clinical, molecular, or immunologic response & have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.~WT-1 analog peptide vaccine"
1165118|NCT00398112|B1|Baseline|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1165119|NCT00398112|P1|Participant Flow|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1165120|NCT00398112|O1|Outcome|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1165121|NCT00398112|O1|Outcome|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1165122|NCT00398112|O1|Outcome|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1165123|NCT00398112|O1|Outcome|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1165219|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
1165124|NCT00398112|O1|Outcome|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1165125|NCT00398112|E1|Reported Event|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1165126|NCT00398086|B4|Baseline|Total|Total of all reporting groups
1165127|NCT00398086|B3|Baseline|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
1165128|NCT00398086|B2|Baseline|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
1165129|NCT00398086|B1|Baseline|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
1165130|NCT00398086|P3|Participant Flow|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
1165131|NCT00398086|P2|Participant Flow|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
1165132|NCT00398086|P1|Participant Flow|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
1165133|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
1165134|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
1165135|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
1165136|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
1165137|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
1165138|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
1165139|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
1165140|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
1165141|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
1165142|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
1165143|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
1165144|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
1165145|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
1165146|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
1165147|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
1165148|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
1165220|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165149|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
1165150|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
1165151|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
1165152|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
1165153|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
1165154|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
1165155|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
1165156|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
1165157|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
1165158|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
1165159|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
1165160|NCT00398086|E3|Reported Event|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
1165161|NCT00398086|E2|Reported Event|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
1165162|NCT00398086|E1|Reported Event|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
1165163|NCT00398073|B3|Baseline|Total|Total of all reporting groups
1165164|NCT00398073|B2|Baseline|2_IM Injection (Bioinjector)|"patients will be injected with 1000 μg of mouse gp100 plasmid DNA intramuscularly. Two injections/day will be administered every two weeks for 4 months (4000 ug of mouse gp100 plasmid/month) for 16 vaccinations.~mouse gp100 plasmid DNA vaccine"
1165165|NCT00398073|B1|Baseline|1_Particle-medicated Epidermal Delivery Group (Gene Gun)|"patients will be randomized to mouse gp100 DNA delivered via gold particles using the PowderMed delivery system (ND10, described above). Two actuations/day will be administered every two weeks for 4 months for a total of 16 actuations. Each actuation consists of 2 μg of plasmid DNA coated onto 1000 μg of gold. The total dose of plasmid DNA given will be 32 μg DNA on 16,000 μg gold.~mouse gp100 plasmid DNA vaccine"
1165166|NCT00398073|P2|Participant Flow|2_IM Injection (Bioinjector)|"patients will be injected with 1000 μg of mouse gp100 plasmid DNA intramuscularly. Two injections/day will be administered every two weeks for 4 months (4000 ug of mouse gp100 plasmid/month) for 16 vaccinations.~mouse gp100 plasmid DNA vaccine"
1165167|NCT00398073|P1|Participant Flow|1_Particle-medicated Epidermal Delivery Group (Gene Gun)|"patients will be randomized to mouse gp100 DNA delivered via gold particles using the PowderMed delivery system (ND10, described above). Two actuations/day will be administered every two weeks for 4 months for a total of 16 actuations. Each actuation consists of 2 μg of plasmid DNA coated onto 1000 μg of gold. The total dose of plasmid DNA given will be 32 μg DNA on 16,000 μg gold.~mouse gp100 plasmid DNA vaccine"
1165168|NCT00398073|O2|Outcome|2_IM Injection (Bioinjector)|"patients will be injected with 1000 μg of mouse gp100 plasmid DNA intramuscularly. Two injections/day will be administered every two weeks for 4 months (4000 ug of mouse gp100 plasmid/month) for 16 vaccinations.~mouse gp100 plasmid DNA vaccine"
1165169|NCT00398073|O1|Outcome|1_Particle-medicated Epidermal Delivery Group (Gene Gun)|"patients will be randomized to mouse gp100 DNA delivered via gold particles using the PowderMed delivery system (ND10, described above). Two actuations/day will be administered every two weeks for 4 months for a total of 16 actuations. Each actuation consists of 2 μg of plasmid DNA coated onto 1000 μg of gold. The total dose of plasmid DNA given will be 32 μg DNA on 16,000 μg gold.~mouse gp100 plasmid DNA vaccine"
1165170|NCT00398073|O2|Outcome|2_IM Injection (Bioinjector)|"patients will be injected with 1000 μg of mouse gp100 plasmid DNA intramuscularly. Two injections/day will be administered every two weeks for 4 months (4000 ug of mouse gp100 plasmid/month) for 16 vaccinations.~mouse gp100 plasmid DNA vaccine"
1165221|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165222|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
1165171|NCT00398073|O1|Outcome|1_Particle-medicated Epidermal Delivery Group (Gene Gun)|"patients will be randomized to mouse gp100 DNA delivered via gold particles using the PowderMed delivery system (ND10, described above). Two actuations/day will be administered every two weeks for 4 months for a total of 16 actuations. Each actuation consists of 2 μg of plasmid DNA coated onto 1000 μg of gold. The total dose of plasmid DNA given will be 32 μg DNA on 16,000 μg gold.~mouse gp100 plasmid DNA vaccine"
1165172|NCT00398073|O2|Outcome|2_IM Injection (Bioinjector)|"patients will be injected with 1000 μg of mouse gp100 plasmid DNA intramuscularly. Two injections/day will be administered every two weeks for 4 months (4000 ug of mouse gp100 plasmid/month) for 16 vaccinations.~mouse gp100 plasmid DNA vaccine"
1165173|NCT00398073|O1|Outcome|1_Particle-medicated Epidermal Delivery Group (Gene Gun)|"patients will be randomized to mouse gp100 DNA delivered via gold particles using the PowderMed delivery system (ND10, described above). Two actuations/day will be administered every two weeks for 4 months for a total of 16 actuations. Each actuation consists of 2 μg of plasmid DNA coated onto 1000 μg of gold. The total dose of plasmid DNA given will be 32 μg DNA on 16,000 μg gold.~mouse gp100 plasmid DNA vaccine"
1165174|NCT00398073|E2|Reported Event|2_IM Injection (Bioinjector)|"patients will be injected with 1000 μg of mouse gp100 plasmid DNA intramuscularly. Two injections/day will be administered every two weeks for 4 months (4000 ug of mouse gp100 plasmid/month) for 16 vaccinations.~mouse gp100 plasmid DNA vaccine"
1165175|NCT00398073|E1|Reported Event|1_Particle-medicated Epidermal Delivery Group (Gene Gun)|"patients will be randomized to mouse gp100 DNA delivered via gold particles using the PowderMed delivery system (ND10, described above). Two actuations/day will be administered every two weeks for 4 months for a total of 16 actuations. Each actuation consists of 2 μg of plasmid DNA coated onto 1000 μg of gold. The total dose of plasmid DNA given will be 32 μg DNA on 16,000 μg gold.~mouse gp100 plasmid DNA vaccine"
1165176|NCT00398047|B1|Baseline|Azacitidine and Darbopoietin and G-CSF|
1165177|NCT00398047|P1|Participant Flow|Combination of Azacitadine and Hematopoietic Growth Factors|azacitidine 100 miligrams/meter squares subcutaneous for 5 days every 28 day cycle,o If the patient had a major hematological improvement; or the patient had grade 3 or 4 hematological toxicities during the first two cycles, and/or there is >=50% reduction in bone marrow cellularity compared to the baseline bone marrow, filgastrim will be administered at dose of 300 µg (if weight is less then 100 kilogram) or 450 µg (if weight is ≥100 kilogram) subcutaneous three times a week on week 2, 3, 4 along with darbopoietin 500 µg subcutaneous on day 8. Patients not meeting the above criteria will have a dose escalation of azacitidine to 125 miligrams/meter subcutaneous for 5 days, beginning on day 57 with growth factor support and filgastrim will be administered at dose of 300 µg (if weight is less then 100 kilogram) or 450 µg (if weight is ≥100 kilogra,) sq three times a week on week 2, 3, 4 along with darbopoietin 500 µg subcutaneous on day 8).
1165178|NCT00398047|O1|Outcome|Azacitidine and Darbopoietin and G-CSF|
1165179|NCT00398047|O1|Outcome|Azacitidine and Darbopoietin and G-CSF|
1165180|NCT00398047|O1|Outcome|Azacitidine and Darbopoietin and G-CSF|
1165181|NCT00398047|O1|Outcome|Azacitidine and Darbopoietin and G-CSF|
1165182|NCT00398047|O1|Outcome|Azacitidine and Darbopoietin and G-CSF|
1165183|NCT00398047|O1|Outcome|Azacitidine and Darbopoietin and G-CSF|azacitidine 100 miligrams/meter squares subcutaneous for 5 days every 28 day cycle,o If the patient had a major hematological improvement; or the patient had grade 3 or 4 hematological toxicities during the first two cycles, and/or there is >=50% reduction in bone marrow cellularity compared to the baseline bone marrow, filgastrim will be administered at dose of 300 µg (if weight is less then 100 kilogram) or 450 µg (if weight is ≥100 kilogram) subcutaneous three times a week on week 2, 3, 4 along with darbopoietin 500 µg subcutaneous on day 8. Patients not meeting the above criteria will have a dose escalation of azacitidine to 125 miligrams/meter subcutaneous for 5 days, beginning on day 57 with growth factor support and filgastrim will be administered at dose of 300 µg (if weight is less then 100 kilogram) or 450 µg (if weight is ≥100 kilogra,) sq three times a week on week 2, 3, 4 along with darbopoietin 500 µg subcutaneous on day 8).
1165184|NCT00398047|O1|Outcome|Azacitidine and Darbopoietin and G-CSF|
1165185|NCT00398047|E1|Reported Event|Azacitidine and Darbopoietin and G-CSF|
1165186|NCT00397982|B1|Baseline|Entire Study|"Patients receive temsirolimus IV over 30 minutes on days 1 and 8 and bevacizumab IV over 30-90 minutes on day 8. Treatment repeats every 14 days for a maximum of 26 courses in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection on day 9 of course 2.~Bevacizumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Temsirolimus: Given IV~Therapeutic Conventional Surgery: Undergo tumor resection"
1165187|NCT00397982|P1|Participant Flow|Treatment (Enzyme Inhibitor, Monoclonal Antibody)|"Patients receive temsirolimus IV over 30 minutes on days 1 and 8 and bevacizumab IV over 30-90 minutes on day 8. Treatment repeats every 14 days for a maximum of 26 courses in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection on day 9 of course 2.~Bevacizumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Temsirolimus: Given IV~Therapeutic Conventional Surgery: Undergo tumor resection"
1165188|NCT00397982|O1|Outcome|Entire Study|17 participants
1165189|NCT00397982|O1|Outcome|Entire Study|17 participants
1165190|NCT00397982|O1|Outcome|Entire Study|17 participants
1165191|NCT00397982|O1|Outcome|Entire Study|17 participants
1165192|NCT00397982|O1|Outcome|Entire Study|17 participants
1165193|NCT00397982|O1|Outcome|Entire Study|Treatment
1165194|NCT00397982|E1|Reported Event|Entire Study|"Patients receive temsirolimus IV over 30 minutes on days 1 and 8 and bevacizumab IV over 30-90 minutes on day 8. Treatment repeats every 14 days for a maximum of 26 courses in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection on day 9 of course 2.~Bevacizumab: Given IV~Laboratory Biomarker Analysis: Correlative studies~Temsirolimus: Given IV~Therapeutic Conventional Surgery: Undergo tumor resection"
1165195|NCT00397930|B3|Baseline|Total|Total of all reporting groups
1165196|NCT00397930|B2|Baseline|Standard Care Control Condition|"The control condition used a standard care format. Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.~fatigue assessment and management~management of therapy complications~quality-of-life assessment"
1166051|NCT00396084|O2|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
1165197|NCT00397930|B1|Baseline|Yoga Intervention (YOCAS)|"The yoga intervention used the standardized Yoga for Cancer Survivors (YOCAS) program, designed by researchers at the University of Rochester Medical Center. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.~fatigue assessment and management~management of therapy complications~quality-of-life assessment~sleep disorder therapy~yoga therapy"
1165198|NCT00397930|P2|Participant Flow|Standard Care Control Condition|"The control condition used a standard care format. Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.~fatigue assessment and management~management of therapy complications~quality-of-life assessment"
1165199|NCT00397930|P1|Participant Flow|Yoga Intervention (YOCAS)|"The yoga intervention used the standardized Yoga for Cancer Survivors (YOCAS) program, designed by researchers at the University of Rochester Medical Center. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.~fatigue assessment and management~management of therapy complications~quality-of-life assessment~sleep disorder therapy~yoga therapy"
1165200|NCT00397930|O2|Outcome|Standard Care Control Condition|"The control condition used a standard care format. Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.~fatigue assessment and management~management of therapy complications~quality-of-life assessment"
1165201|NCT00397930|O1|Outcome|Yoga Intervention (YOCAS)|"The yoga intervention used the standardized Yoga for Cancer Survivors (YOCAS) program, designed by researchers at the University of Rochester Medical Center. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.~fatigue assessment and management~management of therapy complications~quality-of-life assessment~sleep disorder therapy~yoga therapy"
1165202|NCT00397930|E2|Reported Event|Standard Care Control Condition|"The control condition used a standard care format. Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.~fatigue assessment and management~management of therapy complications~quality-of-life assessment"
1165203|NCT00397930|E1|Reported Event|Yoga Intervention (YOCAS)|"The yoga intervention used the standardized Yoga for Cancer Survivors (YOCAS) program, designed by researchers at the University of Rochester Medical Center. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.~fatigue assessment and management~management of therapy complications~quality-of-life assessment~sleep disorder therapy~yoga therapy"
1165204|NCT00397904|B1|Baseline|Cetuximab, Cisplatin, and Irinotecan|Cetuximab will be combined with weekly irinotecan and cisplatin. Patients will receive cetuximab 400 mg/m2 on day 1, week 1. Following this loading dose, patients will receive weekly cetuximab 250 mg/m2 (day 8, 15, 22, etc.) until disease progression or unacceptable toxicity. Patients will continue to receive irinotecan and cisplatin weekly on day 1 and day 8, on an every 21 day cycle. The standard maximum doses are irinotecan 65 mg/m2 and cisplatin 30 mg/m2.
1165205|NCT00397904|P1|Participant Flow|Cetuximab, Cisplatin, and Irinotecan|Cetuximab will be combined with weekly irinotecan and cisplatin. Patients will receive cetuximab 400 mg/m2 on day 1, week 1. Following this loading dose, patients will receive weekly cetuximab 250 mg/m2 (day 8, 15, 22, etc.) until disease progression or unacceptable toxicity. Patients will continue to receive irinotecan and cisplatin weekly on day 1 and day 8, on an every 21 day cycle. The standard maximum doses are irinotecan 65 mg/m2 and cisplatin 30 mg/m2.
1165206|NCT00397904|O1|Outcome|Cetuximab, Cisplatin, and Irinotecan|Cetuximab will be combined with weekly irinotecan and cisplatin. Patients will receive cetuximab 400 mg/m2 on day 1, week 1. Following this loading dose, patients will receive weekly cetuximab 250 mg/m2 (day 8, 15, 22, etc.) until disease progression or unacceptable toxicity. Patients will continue to receive irinotecan and cisplatin weekly on day 1 and day 8, on an every 21 day cycle. The standard maximum doses are irinotecan 65 mg/m2 and cisplatin 30 mg/m2.
1165207|NCT00397904|E1|Reported Event|Cetuximab, Cisplatin, and Irinotecan|Cetuximab will be combined with weekly irinotecan and cisplatin. Patients will receive cetuximab 400 mg/m2 on day 1, week 1. Following this loading dose, patients will receive weekly cetuximab 250 mg/m2 (day 8, 15, 22, etc.) until disease progression or unacceptable toxicity. Patients will continue to receive irinotecan and cisplatin weekly on day 1 and day 8, on an every 21 day cycle. The standard maximum doses are irinotecan 65 mg/m2 and cisplatin 30 mg/m2.
1165208|NCT00397891|B6|Baseline|Total|Total of all reporting groups
1165209|NCT00397891|B5|Baseline|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
1165210|NCT00397891|B4|Baseline|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165211|NCT00397891|B3|Baseline|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165212|NCT00397891|B2|Baseline|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
1165213|NCT00397891|B1|Baseline|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
1165214|NCT00397891|P5|Participant Flow|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
1165215|NCT00397891|P4|Participant Flow|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165216|NCT00397891|P3|Participant Flow|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165217|NCT00397891|P2|Participant Flow|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
1165218|NCT00397891|P1|Participant Flow|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
1165223|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
1165224|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
1165225|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165226|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165227|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
1165228|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
1165229|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165230|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165231|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
1165232|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
1165233|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165234|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165235|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
1165236|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
1165237|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165238|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165239|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
1165240|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
1165241|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165242|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165243|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
1165244|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
1165245|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165246|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165247|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
1165248|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
1165249|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165250|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165251|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
1165252|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
1165253|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165254|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165255|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
1165256|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
1165257|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165258|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165259|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
1165260|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
1165261|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165262|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165263|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
1165264|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
1165265|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
1165266|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165267|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165268|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
1165269|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
1165270|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
1165271|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165272|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165273|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
1165274|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
1165275|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
1165276|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165277|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165278|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
1165279|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
1165280|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
1165281|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165282|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165283|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
1165284|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
1165285|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
1165286|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165287|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165288|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
1165289|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
1165290|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
1165291|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165292|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165293|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
1165294|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
1165295|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
1165296|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165297|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165298|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
1165299|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
1165300|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
1165301|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165302|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165303|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
1165304|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
1165305|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
1165306|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165307|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165308|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
1165309|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
1165310|NCT00397891|E5|Reported Event|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
1165311|NCT00397891|E4|Reported Event|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165312|NCT00397891|E3|Reported Event|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
1165313|NCT00397891|E2|Reported Event|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
1165314|NCT00397891|E1|Reported Event|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
1165315|NCT00397878|B1|Baseline|Treatment (Saracatinib)|Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1165316|NCT00397878|P1|Participant Flow|Treatment (Saracatinib)|Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1165317|NCT00397878|O1|Outcome|Treatment (Saracatinib)|Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1165318|NCT00397878|E1|Reported Event|Treatment (Saracatinib)|Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1165319|NCT00397839|B3|Baseline|Total|Total of all reporting groups
1165320|NCT00397839|B2|Baseline|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
1165321|NCT00397839|B1|Baseline|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
1165322|NCT00397839|P2|Participant Flow|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
1165323|NCT00397839|P1|Participant Flow|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
1165324|NCT00397839|O2|Outcome|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
1165325|NCT00397839|O1|Outcome|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
1165326|NCT00397839|O2|Outcome|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
1165327|NCT00397839|O1|Outcome|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
1165328|NCT00397839|O2|Outcome|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
1165329|NCT00397839|O1|Outcome|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
1165330|NCT00397839|O2|Outcome|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
1165331|NCT00397839|O1|Outcome|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
1165332|NCT00397839|O2|Outcome|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
1165333|NCT00397839|O1|Outcome|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
1165334|NCT00397839|E2|Reported Event|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
1165335|NCT00397839|E1|Reported Event|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
1165336|NCT00397631|B3|Baseline|Total|Total of all reporting groups
1165337|NCT00397631|B2|Baseline|Pioglitazone 30 mg q.d.|The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
1165338|NCT00397631|B1|Baseline|Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
1165339|NCT00397631|P2|Participant Flow|Pioglitazone 30 mg q.d.|The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
1165340|NCT00397631|P1|Participant Flow|Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
1165341|NCT00397631|O2|Outcome|Pioglitazone 30 mg q.d.|The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
1165342|NCT00397631|O1|Outcome|Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
1165343|NCT00397631|O2|Outcome|Pioglitazone 30 mg q.d.|The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
1165344|NCT00397631|O1|Outcome|Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
1165345|NCT00397631|O2|Outcome|Pioglitazone 30 mg q.d.|The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
1165346|NCT00397631|O1|Outcome|Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
1165347|NCT00397631|E2|Reported Event|Pioglitazone 30 mg q.d.|The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
1165348|NCT00397631|E1|Reported Event|Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
1165349|NCT00397540|B3|Baseline|Total|Total of all reporting groups
1165350|NCT00397540|B2|Baseline|RFTA|high ultrasonic wave energy applied using standard radiofrequence thermal ablation (RFTA) intervention technique by incurring coagulation necrosis. Each procedure usually comprises only one session.
1165351|NCT00397540|B1|Baseline|PEIT|99% of ethanol injected using standard percutaneous ethanol injection therapy (PEIT) intervention technique under the guidance of ultrasonography. Each procedure usually comprises 2 to 3 sessions.
1165352|NCT00397540|P2|Participant Flow|RFTA|high ultrasonic wave energy applied using standard radiofrequence thermal ablation (RFTA) intervention technique by incurring coagulation necrosis. Each procedure usually comprises only one session.
1165353|NCT00397540|P1|Participant Flow|Percutaneous Ethanol Injection Therapy|99% of ethanol injected using standard percutaneous ethanol injection therapy (PEIT) intervention technique under the guidance of ultrasonography. Each procedure usually comprises 2 to 3 sessions.
1165354|NCT00397540|O2|Outcome|RFTA|high ultrasonic wave energy applied using standard radiofrequence thermal ablation (RFTA) intervention technique by incurring coagulation necrosis. Each procedure usually comprises only one session.
1165355|NCT00397540|O1|Outcome|PEIT|99% of ethanol injected using standard percutaneous ethanol injection therapy (PEIT) intervention technique under the guidance of ultrasonography. Each procedure usually comprises 2 to 3 sessions.
1165356|NCT00397540|E2|Reported Event|RFTA|high ultrasonic wave energy applied using standard radiofrequence thermal ablation (RFTA) intervention technique by incurring coagulation necrosis. Each procedure usually comprises only one session.
1165357|NCT00397540|E1|Reported Event|Percutaneous Ethanol Injection Therapy|99% of ethanol injected using standard percutaneous ethanol injection therapy (PEIT) intervention technique under the guidance of ultrasonography. Each procedure usually comprises 2 to 3 sessions.
1165358|NCT00397514|B1|Baseline|Congenital Heart Disease Patients|Pacing protocol prior to patient's extubation with 20 min. of conventional right ventricular (RV), preceded and followed by 10 min. of recovery time.
1165359|NCT00397514|P1|Participant Flow|Congenital Heart Disease Pts. Undergoing Biventricular Repair|Pacing protocol prior to patient's extubation with 20 min. of conventional right ventricular (RV), preceded and followed by 10 min. of recovery time.
1165360|NCT00397514|O1|Outcome|Congenital Heart Disease Pts. Undergoing Biventricular Repair|Pacing protocol prior to patient's extubation with 20 min. of conventional right ventricular (RV), preceded and followed by 10 min. of recovery time.
1165361|NCT00397514|O3|Outcome|RV Pacing|QRS duration when patient's extubation with 20 min. of right ventricular pacing
1165362|NCT00397514|O2|Outcome|BiV Pacing|QRS duration when patient's extubation with 20 min. of biventricular pacing
1165363|NCT00397514|O1|Outcome|Baseline|QRS duration at baseline
1165364|NCT00397514|O3|Outcome|RV Pacing|Cardiac Index when patient's extubation with 20 min. of right ventricular pacing
1165365|NCT00397514|O2|Outcome|BiV Pacing|Cardiac Index when patient's extubation with 20 min. of biventricular pacing
1165366|NCT00397514|O1|Outcome|Baseline|Cardiac Index at baseline.
1165367|NCT00397514|E1|Reported Event|Pacing Protocol and RV Pacing|Pacing protocol prior to patient's extubation with 20 min. of conventional right ventricular (RV), preceded and followed by 10 min. of recovery time.
1165368|NCT00397488|B1|Baseline|Sunitinib|Sunitinib in patients with metastatic urothelial carcinoma.
1165369|NCT00397488|P1|Participant Flow|Sunitinib|Sunitinib in patients with metastatic urothelial carcinoma.
1165370|NCT00397488|O1|Outcome|Sunitinib|Sunitinib in patients with metastatic urothelial carcinoma.
1165371|NCT00397488|E1|Reported Event|Sunitinib|Sunitinib in patients with metastatic urothelial carcinoma.
1165372|NCT00397462|B4|Baseline|Total|Total of all reporting groups
1165373|NCT00397462|B3|Baseline|Control|No use of the intervention
1165374|NCT00397462|B2|Baseline|Group 2 High Use|requested that they use the intervention as much as possible during the work day
1165375|NCT00397462|B1|Baseline|Group 1 Low Use|requested that they use the intervention during only the morning or afternoon up to 4 hours
1165376|NCT00397462|P3|Participant Flow|Control|No intervention
1165377|NCT00397462|P2|Participant Flow|Group 2 High Use|requested that they use the intervention as much as possible during the work day
1165378|NCT00397462|P1|Participant Flow|Group 1 Low Use|requested that they use the intervention during only the morning or afternoon up to 4 hours
1165379|NCT00397462|O3|Outcome|High Dose|"Request that calf muscle pump stimulation be used at least four hours per day~calf muscle pump stimulation: Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart"
1165380|NCT00397462|O2|Outcome|Low Dose|"Request that calf muscle pump stimulation be used less than four hours per day~calf muscle pump stimulation: Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart"
1165381|NCT00397462|O1|Outcome|Control|No change to usual behavior
1165382|NCT00397462|O3|Outcome|High Dose|"Request that calf muscle pump stimulation be used at least four hours per day~calf muscle pump stimulation: Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart"
1165383|NCT00397462|O2|Outcome|Low Dose|"Request that calf muscle pump stimulation be used less than four hours per day~calf muscle pump stimulation: Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart"
1165384|NCT00397462|O1|Outcome|Control|No change to usual behavior
1165385|NCT00397462|E3|Reported Event|Control|did not use the intervention
1165386|NCT00397462|E2|Reported Event|Group 2 High Use|requested that they use the intervention as much as possible during the work day
1165387|NCT00397462|E1|Reported Event|Group 1 Low Use|requested that they use the intervention during only the morning or afternoon up to 4 hours
1165388|NCT00397254|B1|Baseline|Baseline Period - Rizatriptan 9 Tablets|Prior to randomization at Visit 2 (to rizatriptan 9 tablets or rizatriptan 27 tablets), all subjects in Baseline were provided with 9 tablets of rizatriptan.
1165389|NCT00397254|P2|Participant Flow|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
1165390|NCT00397254|P1|Participant Flow|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
1165391|NCT00397254|O2|Outcome|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
1165392|NCT00397254|O1|Outcome|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
1165573|NCT00397033|B3|Baseline|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
1165393|NCT00397254|O2|Outcome|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
1165394|NCT00397254|O1|Outcome|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
1165395|NCT00397254|O2|Outcome|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
1165396|NCT00397254|O1|Outcome|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
1165397|NCT00397254|O2|Outcome|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
1165398|NCT00397254|O1|Outcome|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
1165399|NCT00397254|O2|Outcome|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
1165400|NCT00397254|O1|Outcome|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
1165401|NCT00397254|O2|Outcome|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
1165402|NCT00397254|O1|Outcome|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
1165403|NCT00397254|O2|Outcome|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
1165404|NCT00397254|O1|Outcome|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
1165405|NCT00397254|O2|Outcome|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
1165406|NCT00397254|O1|Outcome|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
1165407|NCT00397215|B5|Baseline|Total|Total of all reporting groups
1165408|NCT00397215|B4|Baseline|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165409|NCT00397215|B3|Baseline|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165410|NCT00397215|B2|Baseline|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165411|NCT00397215|B1|Baseline|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165412|NCT00397215|P4|Participant Flow|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165413|NCT00397215|P3|Participant Flow|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165414|NCT00397215|P2|Participant Flow|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165415|NCT00397215|P1|Participant Flow|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165416|NCT00397215|O2|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165417|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165418|NCT00397215|O2|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165419|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165420|NCT00397215|O2|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165421|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165422|NCT00397215|O2|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165423|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165424|NCT00397215|O2|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165425|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165426|NCT00397215|O2|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165427|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165428|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165429|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165430|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165431|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165432|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165433|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165434|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165435|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165436|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165437|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165438|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165439|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165440|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165441|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165442|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165443|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165444|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165445|NCT00397215|O3|Outcome|GSK1562902A 3 Group|GSK1562902A 3 Group Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165446|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165447|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165448|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165449|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165450|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165451|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165452|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165453|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165454|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165455|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165456|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165457|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165458|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165459|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165460|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165461|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165462|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165463|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165464|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165465|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165466|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165467|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165468|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165469|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165470|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165471|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165472|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165473|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165501|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165474|NCT00397215|O2|Outcome|GSK1562902A 2 Group|GSK1562902A 2 Group Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165475|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165476|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165477|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165478|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165479|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165480|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165481|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165482|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165483|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165484|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165485|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165486|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165487|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165488|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165489|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165490|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165491|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165492|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165493|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165494|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165495|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165496|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165497|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165498|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165499|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165500|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165568|NCT00397150|O2|Outcome|No Intervention|Standard of care
1165569|NCT00397150|O1|Outcome|Intervention|Peer-counselling for exclusive breastfeeding
1165502|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165503|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165504|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165505|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165506|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165507|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165508|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165509|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165510|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165511|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165512|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165513|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165514|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165515|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165516|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165517|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165518|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165519|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165520|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165521|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165522|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165523|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165524|NCT00397215|O2|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165525|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165526|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165527|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165528|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165570|NCT00397150|E2|Reported Event|Standard of Care|
1165571|NCT00397150|E1|Reported Event|Peer Counselling for Exclusive Breastfeeding|
1165529|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165530|NCT00397215|O2|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165531|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165532|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165533|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165534|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165535|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165536|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165537|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165538|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165539|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165540|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165541|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165542|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165543|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165544|NCT00397215|E4|Reported Event|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165545|NCT00397215|E3|Reported Event|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
1165546|NCT00397215|E2|Reported Event|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165547|NCT00397215|E1|Reported Event|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
1165548|NCT00397189|B3|Baseline|Total|Total of all reporting groups
1165549|NCT00397189|B2|Baseline|Placebo|Identical tablets to Circadin. Tablets should be taken 1-2 hours before going to bed.
1165550|NCT00397189|B1|Baseline|Circadin|Prolonged release melatonin 2 mg. Tablets should be taken 1-2 hours before going to bed.
1165551|NCT00397189|P2|Participant Flow|Placebo|Identical tablets to Circadin. Tablets should be taken 1-2 hours before going to bed.
1165552|NCT00397189|P1|Participant Flow|Circadin|Prolonged release melatonin 2 mg. Tablets should be taken 1-2 hours before going to bed.
1165553|NCT00397189|O2|Outcome|Placebo|Identical tablets to Circadin. Tablets should be taken 1-2 hours before going to bed.
1165554|NCT00397189|O1|Outcome|Circadin|Prolonged release melatonin 2 mg. Tablets should be taken 1-2 hours before going to bed.
1165555|NCT00397189|E2|Reported Event|Placebo|Identical tablets to Circadin. Tablets should be taken 1-2 hours before going to bed.
1165556|NCT00397189|E1|Reported Event|Circadin|Prolonged release melatonin 2 mg. Tablets should be taken 1-2 hours before going to bed.
1165557|NCT00397150|B3|Baseline|Total|Total of all reporting groups
1165558|NCT00397150|B2|Baseline|No Intervention|Standard of care
1165559|NCT00397150|B1|Baseline|Intervention|Peer-counselling for exclusive breastfeeding
1165560|NCT00397150|P2|Participant Flow|No Intervention|Standard of care
1165561|NCT00397150|P1|Participant Flow|Intervention|Peer-counselling for exclusive breastfeeding
1165562|NCT00397150|O2|Outcome|No Intervention|Standard of care
1165563|NCT00397150|O1|Outcome|Intervention|Peer-counselling for exclusive breastfeeding
1165564|NCT00397150|O2|Outcome|No Intervention|Standard of care
1165565|NCT00397150|O1|Outcome|Intervention|Peer-counselling for exclusive breastfeeding
1165566|NCT00397150|O2|Outcome|No Intervention|Standard of care
1165567|NCT00397150|O1|Outcome|Intervention|Peer-counselling for exclusive breastfeeding
1165574|NCT00397033|B2|Baseline|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
1165575|NCT00397033|B1|Baseline|Placebo|
1165576|NCT00397033|P3|Participant Flow|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
1165577|NCT00397033|P2|Participant Flow|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
1165578|NCT00397033|P1|Participant Flow|Placebo|
1165579|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
1165580|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
1165581|NCT00397033|O1|Outcome|Placebo|
1165582|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
1165583|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
1165584|NCT00397033|O1|Outcome|Placebo|
1165585|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
1165586|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
1165587|NCT00397033|O1|Outcome|Placebo|
1165588|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
1165589|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
1165590|NCT00397033|O1|Outcome|Placebo|
1165591|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
1165592|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
1165593|NCT00397033|O1|Outcome|Placebo|
1165594|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
1165595|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
1165596|NCT00397033|O1|Outcome|Placebo|
1165597|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
1165598|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
1165599|NCT00397033|O1|Outcome|Placebo|
1165600|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
1165601|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
1165602|NCT00397033|O1|Outcome|Placebo|
1165603|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
1165604|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
1165605|NCT00397033|O1|Outcome|Placebo|
1165606|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
1165607|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
1165608|NCT00397033|O1|Outcome|Placebo|
1165609|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
1165610|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
1165611|NCT00397033|O1|Outcome|Placebo|
1165612|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
1165613|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
1165614|NCT00397033|O1|Outcome|Placebo|
1165615|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
1165616|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
1165617|NCT00397033|O1|Outcome|Placebo|
1165618|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
1165619|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
1165620|NCT00397033|O1|Outcome|Placebo|
1165621|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
1165622|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
1165623|NCT00397033|O1|Outcome|Placebo|
1165624|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
1165625|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
1165626|NCT00397033|O1|Outcome|Placebo|
1165627|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
1165628|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
1165629|NCT00397033|O1|Outcome|Placebo|
1165630|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
1165631|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
1165632|NCT00397033|O1|Outcome|Placebo|
1165633|NCT00397033|E3|Reported Event|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
1165634|NCT00397033|E2|Reported Event|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
1165635|NCT00397033|E1|Reported Event|Placebo|
1165636|NCT00396981|B3|Baseline|Total|Total of all reporting groups
1165637|NCT00396981|B2|Baseline|GDC® Coils for Endovascular Aneurysm Occlusion|"GDC® Coils for endovascular aneurysm occlusion~GDC® coils for endovascular aneurysm occlusion : endovascular aneurysm occlusion coil"
1165638|NCT00396981|B1|Baseline|Matrix 2® Coils for Endovascular Aneurysm Occlusion|"Matrix 2® Coils for endovascular aneurysm occlusion~Matrix 2® coils for endovascular aneurysm occlusion : endovascular aneurysm occlusion coil"
1165639|NCT00396981|P2|Participant Flow|GDC® Coils for Endovascular Aneurysm Occlusion|"GDC® Coils for endovascular aneurysm occlusion~GDC® coils for endovascular aneurysm occlusion : endovascular aneurysm occlusion coil"
1165640|NCT00396981|P1|Participant Flow|Matrix 2® Coils for Endovascular Aneurysm Occlusion|"Matrix 2® Coils for endovascular aneurysm occlusion~Matrix 2® coils for endovascular aneurysm occlusion : endovascular aneurysm occlusion coil"
1165641|NCT00396981|O2|Outcome|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
1165642|NCT00396981|O1|Outcome|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
1165643|NCT00396981|O2|Outcome|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
1165644|NCT00396981|O1|Outcome|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
1165645|NCT00396981|O2|Outcome|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
1165646|NCT00396981|O1|Outcome|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
1165647|NCT00396981|O2|Outcome|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
1165648|NCT00396981|O1|Outcome|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
1165649|NCT00396981|O2|Outcome|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
1165650|NCT00396981|O1|Outcome|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
1165651|NCT00396981|O2|Outcome|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
1165652|NCT00396981|O1|Outcome|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
1165653|NCT00396981|O2|Outcome|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
1165654|NCT00396981|O1|Outcome|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
1165655|NCT00396981|E2|Reported Event|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
1165656|NCT00396981|E1|Reported Event|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
1165657|NCT00396877|B3|Baseline|Total|Total of all reporting groups
1165658|NCT00396877|B2|Baseline|Clopidogrel 0.2 mg/kg/Day|
1165659|NCT00396877|B1|Baseline|Placebo|
1165660|NCT00396877|P2|Participant Flow|Clopidogrel 0.2 mg/kg/Day|"Reconstituted solution using Clopidogrel powder administered once daily with a graduated syringe in the mouth or via a feeding tube.~Route: oral or enteric~Frequency: once daily~Dose: daily dose adjusted for weight"
1165661|NCT00396877|P1|Participant Flow|Placebo|Reconstituted solution using Clopidogrel matching placebo powder administered once daily with a graduated syringe in the mouth or via a feeding tube.
1165662|NCT00396877|O2|Outcome|Clopidogrel 0.2 mg/kg/Day|
1165663|NCT00396877|O1|Outcome|Placebo|
1165664|NCT00396877|O2|Outcome|Clopidogrel 0.2 mg/kg/Day|
1165665|NCT00396877|O1|Outcome|Placebo|
1165666|NCT00396877|O2|Outcome|Clopidogrel 0.2 mg/kg/Day|
1165667|NCT00396877|O1|Outcome|Placebo|
1165668|NCT00396877|E2|Reported Event|Clopidogrel 0.2mg/kg/Day|
1165669|NCT00396877|E1|Reported Event|Placebo|
1165670|NCT00396812|B1|Baseline|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
1165671|NCT00396812|P1|Participant Flow|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
1165672|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
1165673|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
1165674|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
1165675|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
1165676|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
1165677|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
1165678|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
1165679|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
1165680|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
1165681|NCT00396812|E1|Reported Event|Rituximab|Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2. Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid.
1165682|NCT00396656|B1|Baseline|Entire Study Population|Includes patients that received valsartan followed by atenolol + hydrochlorothiazide and patients that received atenolol + hydrochlorothiazide followed by valsartan.
1165683|NCT00396656|P2|Participant Flow|Atenolol + Hydrochlorothiazide (HCTZ) Followed by Valsartan|"After a 2-week washout period, patients were treated with atenolol plus HCTZ for 20 weeks followed by one week in which atenolol was tapered off and HCTZ was discontinued. Patients received atenolol 100 mg for 20 weeks. Patients took atenolol tablets orally once a day (od) in the morning. Patients received HCTZ 12.5 mg for 4 weeks starting at the beginning of the 5th week and then received 25 mg for 12 weeks. Patients took HCTZ tablets orally once a day (od) in the morning.~After a second 2-week washout period, patients were treated with valsartan for 20 weeks. Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. Patients took valsartan film coated tablets orally once a day (od) in the morning"
1165684|NCT00396656|P1|Participant Flow|Valsartan Followed by Atenolol + Hydrochlorothiazide (HCTZ)|"After a 2-week washout period, patients were treated with valsartan for 20 weeks followed by one week in which it was tapered off. Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.~After a second 2-week washout period, patients were treated with atenolol plus HCTZ for 20 weeks. Patients received atenolol 100 mg for 20 weeks. Patients took atenolol tablets orally once a day (od) in the morning. Patients received HCTZ 12.5 mg for 4 weeks starting at the beginning of the 5th week and then received 25 mg for 12 weeks. Patients took HCTZ tablets orally once a day (od) in the morning."
1165685|NCT00396656|O2|Outcome|Atenolol + Hydrochlorothiazide|Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.
1165686|NCT00396656|O1|Outcome|Valsartan|Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.
1165687|NCT00396656|O2|Outcome|Atenolol + Hydrochlorothiazide|Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.
1165688|NCT00396656|O1|Outcome|Valsartan|Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.
1165689|NCT00396656|O2|Outcome|Atenolol + Hydrochlorothiazide|Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.
1165690|NCT00396656|O1|Outcome|Valsartan|Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.
1165691|NCT00396656|O2|Outcome|Atenolol + Hydrochlorothiazide|Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.
1165692|NCT00396656|O1|Outcome|Valsartan|Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.
1165693|NCT00396656|O2|Outcome|Atenolol + Hydrochlorothiazide|Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.
1165769|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
1165694|NCT00396656|O1|Outcome|Valsartan|Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.
1165695|NCT00396656|O2|Outcome|Atenolol + Hydrochlorothiazide|Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.
1165696|NCT00396656|O1|Outcome|Valsartan|Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.
1165697|NCT00396656|E2|Reported Event|Atenolol + Hydrochlorothiazide|Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.
1165698|NCT00396656|E1|Reported Event|Valsartan|Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.
1165699|NCT00396630|B3|Baseline|Total|Total of all reporting groups
1165700|NCT00396630|B2|Baseline|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
1165701|NCT00396630|B1|Baseline|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
1165702|NCT00396630|P2|Participant Flow|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
1165703|NCT00396630|P1|Participant Flow|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
1165704|NCT00396630|O2|Outcome|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
1165705|NCT00396630|O1|Outcome|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
1165706|NCT00396630|O2|Outcome|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
1165707|NCT00396630|O1|Outcome|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
1165708|NCT00396630|O2|Outcome|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
1165709|NCT00396630|O1|Outcome|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
1165710|NCT00396630|O2|Outcome|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
1165711|NCT00396630|O1|Outcome|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
1165712|NCT00396630|O2|Outcome|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
1165713|NCT00396630|O1|Outcome|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
1165714|NCT00396630|O2|Outcome|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
1165715|NCT00396630|O1|Outcome|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
1165716|NCT00396630|O1|Outcome|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
1165717|NCT00396630|E2|Reported Event|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
1165718|NCT00396630|E1|Reported Event|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
1165719|NCT00396591|B1|Baseline|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
1165720|NCT00396591|P1|Participant Flow|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
1166052|NCT00396084|O1|Outcome|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
1165721|NCT00396591|O1|Outcome|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
1165722|NCT00396591|O1|Outcome|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
1165723|NCT00396591|O1|Outcome|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
1165724|NCT00396591|O1|Outcome|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
1165725|NCT00396591|O1|Outcome|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
1165726|NCT00396591|O1|Outcome|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
1165727|NCT00396591|O1|Outcome|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
1165728|NCT00396591|E1|Reported Event|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
1165729|NCT00396565|B4|Baseline|Total|Total of all reporting groups
1165730|NCT00396565|B3|Baseline|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
1165731|NCT00396565|B2|Baseline|Placebo|Two placebo tablets once daily for 6 weeks
1165732|NCT00396565|B1|Baseline|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
1165733|NCT00396565|P3|Participant Flow|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
1165734|NCT00396565|P2|Participant Flow|Placebo|Two placebo tablets once daily for 6 weeks
1165735|NCT00396565|P1|Participant Flow|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
1165736|NCT00396565|O3|Outcome|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
1165737|NCT00396565|O2|Outcome|Placebo|Two placebo tablets once daily for 6 weeks
1165738|NCT00396565|O1|Outcome|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
1165739|NCT00396565|O3|Outcome|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
1165740|NCT00396565|O2|Outcome|Placebo|Two placebo tablets once daily for 6 weeks
1165741|NCT00396565|O1|Outcome|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
1165742|NCT00396565|O3|Outcome|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
1165743|NCT00396565|O2|Outcome|Placebo|Two placebo tablets once daily for 6 weeks
1165744|NCT00396565|O1|Outcome|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
1165745|NCT00396565|O3|Outcome|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
1165746|NCT00396565|O2|Outcome|Placebo|Two placebo tablets once daily for 6 weeks
1165747|NCT00396565|O1|Outcome|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
1165748|NCT00396565|O3|Outcome|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
1165749|NCT00396565|O2|Outcome|Placebo|Two placebo tablets once daily for 6 weeks
1165750|NCT00396565|O1|Outcome|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
1165751|NCT00396565|O3|Outcome|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
1165752|NCT00396565|O2|Outcome|Placebo|Two placebo tablets once daily for 6 weeks
1165753|NCT00396565|O1|Outcome|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
1165754|NCT00396565|E3|Reported Event|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
1165755|NCT00396565|E2|Reported Event|Placebo|Two placebo tablets once daily for 6 weeks
1165756|NCT00396565|E1|Reported Event|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
1165757|NCT00396409|B3|Baseline|Total|Total of all reporting groups
1165758|NCT00396409|B2|Baseline|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
1165759|NCT00396409|B1|Baseline|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
1165760|NCT00396409|P2|Participant Flow|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
1165761|NCT00396409|P1|Participant Flow|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
1165762|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
1165763|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
1165764|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
1165765|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
1165766|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
1165767|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
1165768|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
1166739|NCT00395044|O1|Outcome|Gabapentin|1200 mg/daily of Gabapentin
1165770|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
1165771|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
1165772|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
1165773|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
1165774|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
1165775|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
1165776|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
1165777|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
1165778|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
1165779|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
1165780|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
1165781|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
1165782|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
1165783|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
1165784|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
1165785|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
1165786|NCT00396409|E4|Reported Event|Depigoid + Placebo 2008|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
1165787|NCT00396409|E3|Reported Event|Depigoid + Placebo 2007|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
1165788|NCT00396409|E2|Reported Event|Depigoid + Omalizumab 2008|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
1165789|NCT00396409|E1|Reported Event|Depigoid + Omalizumab 2007|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
1165790|NCT00396383|B1|Baseline|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
1165791|NCT00396383|P1|Participant Flow|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
1165792|NCT00396383|O1|Outcome|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
1165793|NCT00396383|O1|Outcome|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
1165794|NCT00396383|O1|Outcome|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
1165795|NCT00396383|O1|Outcome|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
1165796|NCT00396383|O1|Outcome|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
1165797|NCT00396383|O1|Outcome|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
1165798|NCT00396383|E1|Reported Event|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
1165799|NCT00396331|B5|Baseline|Total|Total of all reporting groups
1165800|NCT00396331|B4|Baseline|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165801|NCT00396331|B3|Baseline|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165898|NCT00396266|O1|Outcome|PK Subgroup|Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
1165802|NCT00396331|B2|Baseline|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165803|NCT00396331|B1|Baseline|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165804|NCT00396331|P1|Participant Flow|G-CSF Plus Plerixafor|Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165805|NCT00396331|O1|Outcome|PK Subpopulation|Participants in the pharmacokinetic (PK) subpopulation that offered blood samples for PK analysis. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165806|NCT00396331|O1|Outcome|PK Subpopulation|Participants in the pharmacokinetic (PK) subpopulation that offered blood samples for PK analysis. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165807|NCT00396331|O1|Outcome|PK Subpopulation|Participants in the pharmacokinetic (PK) subpopulation that offered blood samples for PK analysis. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165808|NCT00396331|O1|Outcome|PK Subpopulation|Participants in the pharmacokinetic (PK) subpopulation that offered blood samples for PK analysis. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165809|NCT00396331|O1|Outcome|PK Subpopulation|Participants in the pharmacokinetic (PK) subpopulation that offered blood samples for PK analysis. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165810|NCT00396331|O1|Outcome|PK Subpopulation|Participants in the pharmacokinetic (PK) subpopulation that offered blood samples for PK analysis. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165811|NCT00396331|O5|Outcome|All Patients|
1165812|NCT00396331|O4|Outcome|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165813|NCT00396331|O3|Outcome|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165814|NCT00396331|O2|Outcome|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165815|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165816|NCT00396331|O5|Outcome|All Patients|
1165817|NCT00396331|O4|Outcome|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165818|NCT00396331|O3|Outcome|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165819|NCT00396331|O2|Outcome|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165820|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165821|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165822|NCT00396331|O5|Outcome|All Patients|
1165823|NCT00396331|O4|Outcome|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165824|NCT00396331|O3|Outcome|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165825|NCT00396331|O2|Outcome|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165826|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165827|NCT00396331|O5|Outcome|All Patients|
1165828|NCT00396331|O4|Outcome|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165829|NCT00396331|O3|Outcome|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165830|NCT00396331|O2|Outcome|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165831|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165832|NCT00396331|O5|Outcome|All Patients|
1165833|NCT00396331|O4|Outcome|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165834|NCT00396331|O3|Outcome|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165835|NCT00396331|O2|Outcome|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165836|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165837|NCT00396331|O5|Outcome|All Patients|
1166053|NCT00396084|O4|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
1165838|NCT00396331|O4|Outcome|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165839|NCT00396331|O3|Outcome|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165840|NCT00396331|O2|Outcome|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165841|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165842|NCT00396331|O5|Outcome|All Patients|
1165843|NCT00396331|O4|Outcome|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165844|NCT00396331|O3|Outcome|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165845|NCT00396331|O2|Outcome|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165846|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165847|NCT00396331|O5|Outcome|All Patients|
1165848|NCT00396331|O4|Outcome|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165849|NCT00396331|O3|Outcome|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165850|NCT00396331|O2|Outcome|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165851|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165852|NCT00396331|E4|Reported Event|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165853|NCT00396331|E3|Reported Event|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165854|NCT00396331|E2|Reported Event|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165980|NCT00396097|O1|Outcome|Standard Dose Arm|The participants received subcutaneous genotropin daily, at maintained standard dose of 0.37 mg/kg/week, throughout the four years.
1165855|NCT00396331|E1|Reported Event|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
1165856|NCT00396318|B1|Baseline|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
1165857|NCT00396318|P1|Participant Flow|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
1165858|NCT00396318|O1|Outcome|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
1165859|NCT00396318|O1|Outcome|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
1165860|NCT00396318|O1|Outcome|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
1165861|NCT00396318|O1|Outcome|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
1165862|NCT00396318|O1|Outcome|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
1165863|NCT00396318|O1|Outcome|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
1165864|NCT00396318|O1|Outcome|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
1165865|NCT00396318|O1|Outcome|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
1165866|NCT00396318|E1|Reported Event|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
1165867|NCT00396292|B3|Baseline|Total|Total of all reporting groups
1165868|NCT00396292|B2|Baseline|Oral Iron Tablets|325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42
1165869|NCT00396292|B1|Baseline|VIT-45|A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered
1165870|NCT00396292|P2|Participant Flow|Oral Iron Tablets|325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42
1165871|NCT00396292|P1|Participant Flow|VIT-45|A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered
1165872|NCT00396292|O2|Outcome|Oral Iron Tablets|325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42
1165873|NCT00396292|O1|Outcome|VIT-45|A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered
1165874|NCT00396292|E2|Reported Event|Oral Iron Tablets|325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42
1165875|NCT00396292|E1|Reported Event|VIT-45|A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered
1165876|NCT00396279|B1|Baseline|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
1165877|NCT00396279|P1|Participant Flow|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
1165878|NCT00396279|O1|Outcome|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
1166047|NCT00396084|O2|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
1165879|NCT00396279|O1|Outcome|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
1165880|NCT00396279|O1|Outcome|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
1165881|NCT00396279|O1|Outcome|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
1165882|NCT00396279|O1|Outcome|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
1165883|NCT00396279|O1|Outcome|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
1165884|NCT00396279|E1|Reported Event|Denosumab 120 mg Q4W|Participants received a dose loading regimen of 3 subcutaneous injections of denosumab 120 mg every week for 3 weeks (study Days 1, 8, and 15), followed by a week of rest, and then 120 mg denosumab once every 4 weeks (Q4W) from Day 29.
1165885|NCT00396266|B3|Baseline|Total|Total of all reporting groups
1165886|NCT00396266|B2|Baseline|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1165887|NCT00396266|B1|Baseline|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1165888|NCT00396266|P2|Participant Flow|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1165889|NCT00396266|P1|Participant Flow|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1165890|NCT00396266|O1|Outcome|PD Subgroup|Subgroup of 4 patients (3 MM and 1 NHL) for which a pharmacodynamic (PD) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
1165891|NCT00396266|O1|Outcome|PK Subgroup|Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
1165892|NCT00396266|O3|Outcome|Total|All patients.
1165893|NCT00396266|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1165894|NCT00396266|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1165895|NCT00396266|O1|Outcome|PK Subgroup|Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
1165896|NCT00396266|O1|Outcome|PK Subgroup|Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
1165897|NCT00396266|O1|Outcome|PK Subgroup|Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
1166048|NCT00396084|O1|Outcome|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
1166049|NCT00396084|O4|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
1165899|NCT00396266|O1|Outcome|PK Subgroup|Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
1165900|NCT00396266|O1|Outcome|Non-hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1165901|NCT00396266|O3|Outcome|Total|All patients.
1165902|NCT00396266|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1165903|NCT00396266|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1165904|NCT00396266|O3|Outcome|Total|All patients.
1165905|NCT00396266|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1165906|NCT00396266|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1165907|NCT00396266|E2|Reported Event|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1165908|NCT00396266|E1|Reported Event|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1165909|NCT00396253|B1|Baseline|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
1165910|NCT00396253|P1|Participant Flow|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
1165911|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
1165912|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
1165913|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
1165914|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
1165929|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
1165915|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
1165916|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
1165917|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
1165918|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
1165919|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
1165920|NCT00396253|E1|Reported Event|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
1165921|NCT00396201|B1|Baseline|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
1165922|NCT00396201|P1|Participant Flow|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin's disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with granulocyte-colony stimulating factor (G-CSF) [10 µg/kg each day (QD)] and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
1165923|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
1165924|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
1165925|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
1165926|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
1165927|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
1165928|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
1165955|NCT00396136|O1|Outcome|Corox OTW Unipolar Lead|Study Participants followed for three years post implant.
1165956|NCT00396136|O1|Outcome|Corox OTW Unipolar Lead|Study Participants followed for three years post implant.
1165957|NCT00396136|E1|Reported Event|Group 1|
1165958|NCT00396097|B3|Baseline|Total|Total of all reporting groups
1165930|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
1165931|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
1165932|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
1165933|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
1165934|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
1165935|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
1165936|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
1165937|NCT00396201|E1|Reported Event|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
1165938|NCT00396162|B3|Baseline|Total|Total of all reporting groups
1165939|NCT00396162|B2|Baseline|Placebo Pill|"Placebo pills on same schedule as active intervention.~probiotic containing L.rhamnosus R0011 strain: 500 million active cells of L rhamnosus R0011 strain per tablet bid for 4 weeks"
1165940|NCT00396162|B1|Baseline|Probiotic|"drug~probiotic containing L.rhamnosus R0011 strain: 500 million active cells of L rhamnosus R0011 strain per tablet bid for 4 weeks"
1165941|NCT00396162|P2|Participant Flow|Placebo|Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
1165942|NCT00396162|P1|Participant Flow|Probiotic|The study protocol scheduled daily oral supplementation of either the probiotic or the placebo twice daily for four weeks. The probiotic product was a chewable tablet containing 500 million active cells of L rhamnosus R0011 strain per tablet. Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
1165943|NCT00396162|O2|Outcome|Placebo|Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
1165944|NCT00396162|O1|Outcome|Probiotic|The study protocol scheduled daily oral supplementation of either the probiotic or the placebo twice daily for four weeks. The probiotic product was a chewable tablet containing 500 million active cells of L rhamnosus R0011 strain per tablet. Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
1165945|NCT00396162|O2|Outcome|Active Intervention|The study protocol scheduled daily oral supplementation of either the probiotic or the placebo twice daily for four weeks. The probiotic product was a chewable tablet containing 500 million active cells of L rhamnosus R0011 strain per tablet. Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
1165946|NCT00396162|O1|Outcome|Placebo|Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
1165947|NCT00396162|O2|Outcome|Probiotic|"L. rhamnosus R0011 strain~probiotic containing L.rhamnosus R0011 strain: 500 million active cells of L rhamnosus R0011 strain per tablet bid for 4 weeks"
1165948|NCT00396162|O1|Outcome|Placebo Pill|"Placebo pills on same schedule as active intervention.~Placebo: Placebo pill"
1165949|NCT00396162|O2|Outcome|Placebo|Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
1165950|NCT00396162|O1|Outcome|Probiotic|The study protocol scheduled daily oral supplementation of either the probiotic or the placebo twice daily for four weeks. The probiotic product was a chewable tablet containing 500 million active cells of L rhamnosus R0011 strain per tablet. Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
1165951|NCT00396162|E2|Reported Event|Placebo|Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
1165952|NCT00396162|E1|Reported Event|Active Intervention|The study protocol scheduled daily oral supplementation of either the probiotic or the placebo twice daily for four weeks. The probiotic product was a chewable tablet containing 500 million active cells of L rhamnosus R0011 strain per tablet. Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
1165953|NCT00396136|B1|Baseline|Corox OTW Unipolar Lead|Study Participants followed for three years post implant.
1165954|NCT00396136|P1|Participant Flow|Corox OTW Unipolar Lead|Study Participants followed for three years post implant.
1165959|NCT00396097|B2|Baseline|Individualized Dose Arm|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.
1165960|NCT00396097|B1|Baseline|Standard Dose Arm|The participants received subcutaneous genotropin daily, at a maintained standard dose of 0.37 mg/kg/week, throughout the four years.
1165961|NCT00396097|P2|Participant Flow|Individualized Dose Arm|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.
1165962|NCT00396097|P1|Participant Flow|Standard Dose Arm|The participants received subcutaneous genotropin, at a maintained standard dose of 0.37 mg/kg/week, throughout the four years.
1165963|NCT00396097|O4|Outcome|Individualized Dose Arm 0.24 mg/kg/Week|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses 0.24 mg/kg/week for the remaining 2 years.
1165964|NCT00396097|O3|Outcome|Individualized Dose Arm 0.18 mg/kg/Week|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses 0.18 mg/kg/week for the remaining 2 years.
1165965|NCT00396097|O2|Outcome|Individualized Dose Arm Overall|"The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.~The combined individualized dose group (N=202) includes 179 subjects who, at the start of the maintenance phase, were randomized to either 0.18 or 0.24 mg/kg/week dose subgroup. The remaining 23 subjects were not randomized at the start of the maintenance phase either due to early termination (n=19), or because they were initially randomized to the individualized dose, had the dose calculated to 0 mg, and had received the standard dose for the remainder of the study (n=4)."
1165966|NCT00396097|O1|Outcome|Standard Dose Arm|The participants received subcutaneous genotropin daily, at maintained standard dose of 0.37 mg/kg/week, throughout the four years.
1165967|NCT00396097|O4|Outcome|Individualized Dose Arm 0.24/mg/kg/Week|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses 0.24 mg/kg/week for the remaining 2 years.
1165968|NCT00396097|O3|Outcome|Individualized Dose Arm 0.18 mg/kg/Week|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses 0.18 mg/kg/week for the remaining 2 years.
1165969|NCT00396097|O2|Outcome|Individualized Dose Arm Overall|"The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.~The combined individualized dose group (N=202) includes 179 subjects who, at the start of the maintenance phase, were randomized to either 0.18 or 0.24 mg/kg/week dose subgroup. The remaining 23 subjects were not randomized at the start of the maintenance phase either due to early termination (n=19), or because they were initially randomized to the individualized dose, had the dose calculated to 0 mg, and had received the standard dose for the remainder of the study (n=4)."
1165970|NCT00396097|O1|Outcome|Standard Dose Arm|The participants received subcutaneous genotropin daily, at maintained standard dose of 0.37 mg/kg/week, throughout the four years.
1165971|NCT00396097|O4|Outcome|Individualized Dose Arm 0.24 mg/kg/Week|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses 0.24 mg/kg/week for the remaining 2 years.
1165972|NCT00396097|O3|Outcome|Individualized Dose Arm 0.18 mg/kg/Week|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses 0.18 mg/kg/week for the remaining 2 years.
1165973|NCT00396097|O2|Outcome|Individualized Dose Arm Overall|"The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.~The combined individualized dose group (N=202) includes 179 subjects who, at the start of the maintenance phase, were randomized to either 0.18 or 0.24 mg/kg/week dose subgroup. The remaining 23 subjects were not randomized at the start of the maintenance phase either due to early termination (n=19), or because they were initially randomized to the individualized dose, had the dose calculated to 0 mg, and had received the standard dose for the remainder of the study (n=4)."
1165974|NCT00396097|O1|Outcome|Standard Dose Arm|The participants received subcutaneous genotropin daily, at maintained standard dose of 0.37 mg/kg/week, throughout the four years.
1165975|NCT00396097|O2|Outcome|Individualized Dose Arm|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.
1165976|NCT00396097|O1|Outcome|Standard Dose Arm|The participants received subcutaneous genotropin daily, at maintained standard dose of 0.37 mg/kg/week, throughout the four years.
1165977|NCT00396097|O2|Outcome|Individualized Dose Arm|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.
1165978|NCT00396097|O1|Outcome|Standard Dose Arm|The participants received subcutaneous genotropin daily, at maintained standard dose of 0.37 mg/kg/week, throughout the four years.
1165979|NCT00396097|O2|Outcome|Individualized Dose Arm|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.
1166050|NCT00396084|O3|Outcome|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
1165981|NCT00396097|E2|Reported Event|Individualized Dose Arm|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.
1165982|NCT00396097|E1|Reported Event|Standard Dose Arm|The participants received subcutaneous genotropin daily, at a maintained standard dose of 0.37 mg/kg/week, throughout the four years.
1165983|NCT00396084|B7|Baseline|Total|Total of all reporting groups
1165984|NCT00396084|B6|Baseline|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
1165985|NCT00396084|B5|Baseline|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
1165986|NCT00396084|B4|Baseline|Linezolid 600 mg / Twice Daily|Linezolid 600 mg twice daily x 7 days
1165987|NCT00396084|B3|Baseline|Linezolid 600 mg / Once Daily|Linezolid 600 mg/once daily x 7days
1165988|NCT00396084|B2|Baseline|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
1165989|NCT00396084|B1|Baseline|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
1165990|NCT00396084|P6|Participant Flow|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
1165991|NCT00396084|P5|Participant Flow|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
1165992|NCT00396084|P4|Participant Flow|Linezolid 600 mg / Twice Daily|Linezolid 600 mg twice daily x 7 days
1165993|NCT00396084|P3|Participant Flow|Linezolid 600 mg / Once Daily|Linezolid 600 mg/once daily x 7days
1165994|NCT00396084|P2|Participant Flow|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
1165995|NCT00396084|P1|Participant Flow|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
1165996|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
1165997|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid 600 mg/day x 7 days
1165998|NCT00396084|O1|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
1165999|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
1166000|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
1166001|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
1166002|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
1166003|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
1166004|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
1166005|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
1166006|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
1166007|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
1166008|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
1166009|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
1166010|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
1166011|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
1166012|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
1166013|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
1166014|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
1166015|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
1166016|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
1166017|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
1166018|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
1166019|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
1166020|NCT00396084|O4|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
1166021|NCT00396084|O3|Outcome|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
1166022|NCT00396084|O2|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7 days
1166023|NCT00396084|O1|Outcome|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
1166024|NCT00396084|O4|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
1166025|NCT00396084|O3|Outcome|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
1166026|NCT00396084|O2|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
1166027|NCT00396084|O1|Outcome|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
1166028|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
1166029|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
1166030|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
1166031|NCT00396084|O4|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
1166032|NCT00396084|O3|Outcome|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
1166033|NCT00396084|O2|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7 days
1166034|NCT00396084|O1|Outcome|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
1166035|NCT00396084|O4|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
1166036|NCT00396084|O3|Outcome|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
1166037|NCT00396084|O2|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
1166038|NCT00396084|O1|Outcome|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
1166039|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
1166040|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
1166041|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
1166042|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
1166043|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
1166044|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
1166045|NCT00396084|O4|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
1166046|NCT00396084|O3|Outcome|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
1166054|NCT00396084|O3|Outcome|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
1166055|NCT00396084|O2|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
1166056|NCT00396084|O1|Outcome|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
1166057|NCT00396084|O4|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
1166058|NCT00396084|O3|Outcome|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
1166059|NCT00396084|O2|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
1166060|NCT00396084|O1|Outcome|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
1166061|NCT00396084|E6|Reported Event|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
1166062|NCT00396084|E5|Reported Event|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
1166063|NCT00396084|E4|Reported Event|Linezolid 600 mg / Twice Daily|Linezolid 600 mg twice daily x 7 days
1166064|NCT00396084|E3|Reported Event|Linezolid 600 mg / Once Daily|Linezolid 600 mg/once daily x 7days
1166065|NCT00396084|E2|Reported Event|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
1166066|NCT00396084|E1|Reported Event|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
1166067|NCT00396032|B3|Baseline|Total|Total of all reporting groups
1166068|NCT00396032|B2|Baseline|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
1166069|NCT00396032|B1|Baseline|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
1166070|NCT00396032|P2|Participant Flow|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
1166071|NCT00396032|P1|Participant Flow|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
1166072|NCT00396032|O2|Outcome|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
1166073|NCT00396032|O1|Outcome|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
1166074|NCT00396032|O2|Outcome|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
1166075|NCT00396032|O1|Outcome|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
1166076|NCT00396032|O2|Outcome|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
1166077|NCT00396032|O1|Outcome|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
1166078|NCT00396032|O2|Outcome|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
1166079|NCT00396032|O1|Outcome|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
1166080|NCT00396032|O2|Outcome|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
1166081|NCT00396032|O1|Outcome|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
1166082|NCT00396032|E2|Reported Event|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
1166083|NCT00396032|E1|Reported Event|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
1166084|NCT00396006|B1|Baseline|Participants Treated With ARALAST Fr. IV-1|
1166085|NCT00396006|P1|Participant Flow|Participants Treated With ARALAST Fraction IV-1 (Fr. IV-1)|Weekly infusions of ARALAST Fr. IV-1 were administered to participants at a dosage of 60 mg/kg
1166086|NCT00396006|O1|Outcome|Intent to Treat|Treated participants with relevant assessments, e.g. if pre- and post-treatment BAL procedures were required to assess the parameter, then the participant had both evaluable BAL procedures.
1166087|NCT00396006|O1|Outcome|Intent to Treat|Treated participants with relevant assessments, e.g. if pre- and post-treatment BAL procedures were required to assess the parameter, then the participant had both evaluable BAL procedures.
1166088|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
1166089|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
1166090|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
1166091|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
1166092|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
1166093|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
1166094|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
1166095|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
1166096|NCT00396006|O1|Outcome|Intent to Treat|Treated participants with relevant assessments, e.g. if pre- and post-treatment BAL procedures were required to assess the parameter, then the participant had both evaluable BAL procedures.
1166097|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
1166098|NCT00396006|E1|Reported Event|Intent to Treat|Treated participants with relevant assessments, e.g. if pre- and post-treatment BAL procedures were required to assess the parameter, then the participant had both evaluable BAL procedures.
1166099|NCT00395993|B3|Baseline|Total|Total of all reporting groups
1166100|NCT00395993|B2|Baseline|Oral Iron Tablets|325 mg tablets TID on Days 0 through Day 42
1166101|NCT00395993|B1|Baseline|Ferric Carboxymaltose (FCM)|Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered
1166102|NCT00395993|P2|Participant Flow|Oral Iron Tablets|325 mg tablets TID on Days 0 through Day 42
1166103|NCT00395993|P1|Participant Flow|Ferric Carboxymaltose (FCM)|Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered
1166104|NCT00395993|O2|Outcome|Oral Iron Tablets|325 mg tablets TID on Days 0 through Day 42
1166105|NCT00395993|O1|Outcome|Ferric Carboxymaltose (FCM)|Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered
1166106|NCT00395993|E2|Reported Event|Oral Iron Tablets|325 mg tablets TID on Days 0 through Day 42
1166107|NCT00395993|E1|Reported Event|Ferric Carboxymaltose (FCM)|Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered
1166108|NCT00395967|B1|Baseline|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
1166109|NCT00395967|P1|Participant Flow|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
1166110|NCT00395967|O1|Outcome|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
1166111|NCT00395967|O1|Outcome|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
1166112|NCT00395967|O1|Outcome|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
1166113|NCT00395967|O1|Outcome|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
1166114|NCT00395967|O1|Outcome|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
1166115|NCT00395967|O1|Outcome|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
1166116|NCT00395967|E1|Reported Event|All Patients|All patients (3 NHL, 1 MM, and 1 HD).
1166117|NCT00395876|B3|Baseline|Total|Total of all reporting groups
1166118|NCT00395876|B2|Baseline|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
1166119|NCT00395876|B1|Baseline|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
1166182|NCT00395850|B3|Baseline|Disulfiram 375|Disulfiram at 375 mg/day
1166183|NCT00395850|B2|Baseline|Disulfiram 250|disulfiram at 250 mg/day
1166184|NCT00395850|B1|Baseline|Placebo|microcrystalline cellulose
1166120|NCT00395876|P2|Participant Flow|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
1166121|NCT00395876|P1|Participant Flow|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
1166122|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
1166123|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
1166124|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
1166125|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
1166126|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
1166127|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
1166128|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
1166129|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
1166185|NCT00395850|P4|Participant Flow|Disulfiram 500|Disulfiram at 500 mg/day
1166186|NCT00395850|P3|Participant Flow|Disulfiram 375|Disulfiram at 375 mg/day
1166130|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
1166131|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
1166132|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
1166133|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
1166134|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
1166135|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
1166136|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
1166137|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
1166138|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
1166139|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
1166187|NCT00395850|P2|Participant Flow|Disulfiram 250|disulfiram at 250 mg/day
1166188|NCT00395850|P1|Participant Flow|Placebo|microcrystalline cellulose
1166140|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
1166141|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
1166142|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
1166143|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
1166144|NCT00395876|E2|Reported Event|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
1166145|NCT00395876|E1|Reported Event|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
1166146|NCT00395863|B3|Baseline|Total|Total of all reporting groups
1166147|NCT00395863|B2|Baseline|Magnevist, Then MultiHance|0.1 mmol/kg injection of each product
1166148|NCT00395863|B1|Baseline|MultiHance, Then Magnevist|0.1 mmol/kg injection of each product
1166149|NCT00395863|P2|Participant Flow|Magnevist, Then MultiHance|0.1 mmol/kg injection of each product
1166150|NCT00395863|P1|Participant Flow|MultiHance, Then Magnevist|0.1 mmol/kg injection of each product
1166151|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
1166152|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
1166153|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
1166154|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
1166155|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
1166156|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
1166157|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
1166158|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
1166159|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
1166160|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
1166161|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
1166162|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
1166163|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
1166164|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
1166165|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
1166166|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
1166167|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
1166168|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
1166169|NCT00395863|O3|Outcome|Reader 3|
1166170|NCT00395863|O2|Outcome|Reader 2|
1166171|NCT00395863|O1|Outcome|Reader 1|
1166172|NCT00395863|O3|Outcome|Reader 3|
1166173|NCT00395863|O2|Outcome|Reader 2|
1166174|NCT00395863|O1|Outcome|Reader 1|
1166175|NCT00395863|O3|Outcome|Reader 3|
1166176|NCT00395863|O2|Outcome|Reader 2|
1166177|NCT00395863|O1|Outcome|Reader 1|
1166178|NCT00395863|E2|Reported Event|Magnevist|Adverse events experienced by patients occurred relative to the administration of Magnevist.
1166179|NCT00395863|E1|Reported Event|MultiHance|Adverse events experienced by patients occurred relative to the administration of MultiHance.
1166180|NCT00395850|B5|Baseline|Total|Total of all reporting groups
1166181|NCT00395850|B4|Baseline|Disulfiram 500|Disulfiram at 500 mg/day
1166197|NCT00395850|E4|Reported Event|Disulfiram 500|Disulfiram at 500 mg/day
1166198|NCT00395850|E3|Reported Event|Disulfiram 375|Disulfiram at 375 mg/day
1166199|NCT00395850|E2|Reported Event|Disulfiram 250|disulfiram at 250 mg/day
1166200|NCT00395850|E1|Reported Event|Placebo|microcrystalline cellulose
1166201|NCT00395746|B4|Baseline|Total|Total of all reporting groups
1166202|NCT00395746|B3|Baseline|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166203|NCT00395746|B2|Baseline|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166204|NCT00395746|B1|Baseline|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166205|NCT00395746|P3|Participant Flow|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166206|NCT00395746|P2|Participant Flow|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166207|NCT00395746|P1|Participant Flow|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166208|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166209|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166210|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166211|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166212|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166213|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166214|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166215|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166216|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166217|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166218|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166219|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166220|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166221|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166222|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166223|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166224|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166225|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166226|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166227|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166228|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166229|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166230|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166231|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166232|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166233|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166234|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166235|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166236|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166237|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166238|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166239|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166740|NCT00395044|O2|Outcome|Placebo|Matched Placebo
1166240|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166241|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166242|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166243|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166244|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166245|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166246|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166247|NCT00395746|E3|Reported Event|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166248|NCT00395746|E2|Reported Event|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166249|NCT00395746|E1|Reported Event|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
1166250|NCT00395733|B3|Baseline|Total|Total of all reporting groups
1166251|NCT00395733|B2|Baseline|Period 1: Gadopentate Dimeglumine, Period 2: Gadobutrol|Period 1: Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). Period 2: Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW).
1166252|NCT00395733|B1|Baseline|Period 1: Gadobutrol, Period 2: Gadopentate Dimeglumine|Period 1: Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). Period 2: Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW).
1166253|NCT00395733|P2|Participant Flow|Period 1: Gadopentate Dimeglumine, Period 2: Gadobutrol|Period 1: Gadopentate dimeglumine 0.2 - 0.3 mmol/kg BW (Magnevist, BAY86-4882); Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). Period 2: Gadobutrol 0.2 - 0.3 mmol/kg BW (Gadavist, BAY86-4875); Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW).
1166254|NCT00395733|P1|Participant Flow|Period 1: Gadobutrol, Period 2: Gadopentate Dimeglumine|Period 1: Gadobutrol 0.2 - 0.3 mmol/kg Body Weight (BW) (Gadavist, BAY86-4875); Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). Period 2: Gadopentate dimeglumine 0.2 - 0.3 mmol/kg BW (Magnevist, BAY86-4882); Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW).
1166255|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
1166256|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
1166257|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
1166258|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
1166259|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
1166260|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
1166261|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
1166262|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
1166263|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
1166264|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
1166265|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
1166266|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
1166267|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
1166268|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
1166269|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
1166270|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
1166271|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
1166272|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
1166273|NCT00395733|E2|Reported Event|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
1166274|NCT00395733|E1|Reported Event|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
1166275|NCT00395694|B3|Baseline|Total|Total of all reporting groups
1166276|NCT00395694|B2|Baseline|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
1166277|NCT00395694|B1|Baseline|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
1166278|NCT00395694|P2|Participant Flow|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
1166279|NCT00395694|P1|Participant Flow|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
1166280|NCT00395694|O1|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
1166329|NCT00395629|E3|Reported Event|Deferasirox (ICL670) 15 mg/kg/day_Core Study|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
1166330|NCT00395629|E2|Reported Event|Deferasirox (ICL670) 10 mg/kg/day_Core Study|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
1166741|NCT00395044|O1|Outcome|Gabapentin|1200 mg/daily of Gabapentin
1166742|NCT00395044|O2|Outcome|Placebo|Matched Placebo
1166281|NCT00395694|O3|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
1166282|NCT00395694|O2|Outcome|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
1166283|NCT00395694|O1|Outcome|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
1166284|NCT00395694|O1|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
1166285|NCT00395694|O1|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
1166286|NCT00395694|O3|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
1166287|NCT00395694|O2|Outcome|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
1166288|NCT00395694|O1|Outcome|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
1166331|NCT00395629|E1|Reported Event|Deferasirox (ICL670) 5 mg/kg/day_Core Study|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
1166332|NCT00395512|B5|Baseline|Total|Total of all reporting groups
1166333|NCT00395512|B4|Baseline|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166743|NCT00395044|O1|Outcome|Gabapentin|1200 mg/daily of Gabapentin
1166289|NCT00395694|O3|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
1166290|NCT00395694|O2|Outcome|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
1166291|NCT00395694|O1|Outcome|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
1166292|NCT00395694|O3|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
1166293|NCT00395694|O2|Outcome|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
1166294|NCT00395694|O1|Outcome|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
1166295|NCT00395694|O3|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
1166296|NCT00395694|O2|Outcome|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
1166297|NCT00395694|O1|Outcome|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
1166744|NCT00395044|O2|Outcome|Placebo|Matched Placebo
1166298|NCT00395694|O1|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
1166299|NCT00395694|O1|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
1166300|NCT00395694|O3|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
1166301|NCT00395694|O2|Outcome|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
1166302|NCT00395694|O1|Outcome|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
1166303|NCT00395694|O3|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
1166304|NCT00395694|O2|Outcome|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
1166305|NCT00395694|O1|Outcome|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
1166334|NCT00395512|B3|Baseline|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166335|NCT00395512|B2|Baseline|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166336|NCT00395512|B1|Baseline|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166745|NCT00395044|O1|Outcome|Gabapentin|1200 mg/daily of Gabapentin
1166306|NCT00395694|E3|Reported Event|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
1166307|NCT00395694|E2|Reported Event|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
1166308|NCT00395694|E1|Reported Event|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
1166309|NCT00395642|B1|Baseline|Home Monitoring With Weight and BP Remote Monitoring|Device based Home Monitoring with weight and blood pressure (BP) remote monitoring
1166310|NCT00395642|P1|Participant Flow|Home Monitoring With Weight and BP Remote Monitoring|Device based Home Monitoring with weight and blood pressure (BP) remote monitoring
1166311|NCT00395642|O1|Outcome|Home Monitoring With Weight and BP Remote Monitoring|Device based Home Monitoring with weight and blood pressure (BP) remote monitoring
1166312|NCT00395642|E1|Reported Event|Home Monitoring With Weight and BP Remote Monitoring|Device based Home Monitoring with weight and blood pressure (BP) remote monitoring
1166313|NCT00395629|B4|Baseline|Total|Total of all reporting groups
1166314|NCT00395629|B3|Baseline|Deferasirox (ICL670) 15 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
1166315|NCT00395629|B2|Baseline|Deferasirox (ICL670) 10 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
1166316|NCT00395629|B1|Baseline|Deferasirox (ICL670) 5 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
1166317|NCT00395629|P3|Participant Flow|Deferasirox (ICL670) 15 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
1166318|NCT00395629|P2|Participant Flow|Deferasirox (ICL670) 10 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
1166319|NCT00395629|P1|Participant Flow|Deferasirox (ICL670) 5 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
1166320|NCT00395629|O3|Outcome|Deferasirox (ICL670) 15 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
1166321|NCT00395629|O2|Outcome|Deferasirox (ICL670) 10 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
1166322|NCT00395629|O1|Outcome|Deferasirox (ICL670) 5 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
1166323|NCT00395629|O3|Outcome|Deferasirox (ICL670) 15 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
1166324|NCT00395629|O2|Outcome|Deferasirox (ICL670) 10 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
1166325|NCT00395629|O1|Outcome|Deferasirox (ICL670) 5 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
1166326|NCT00395629|E6|Reported Event|Deferasirox (ICL670) 15 mg/kg/day_Extension Study|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
1166327|NCT00395629|E5|Reported Event|Deferasirox (ICL670) 10 mg/kg/day_Extension Study|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
1166328|NCT00395629|E4|Reported Event|Deferasirox (ICL670) 5 mg/kg/day_Extension Study|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
1166337|NCT00395512|P4|Participant Flow|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166338|NCT00395512|P3|Participant Flow|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166339|NCT00395512|P2|Participant Flow|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166340|NCT00395512|P1|Participant Flow|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166341|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166342|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166343|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166344|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166345|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166346|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166347|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166348|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166349|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166350|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166351|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166352|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166353|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166354|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166355|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166356|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166357|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166358|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166359|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166360|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166361|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166362|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166363|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166364|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166365|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166366|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166367|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166368|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166369|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166370|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166371|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166372|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166373|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166374|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166375|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166376|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166377|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166378|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166379|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166380|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166381|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166382|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166383|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166384|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166385|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166386|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166387|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166388|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166389|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166390|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166391|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166392|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166393|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166394|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166395|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166396|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166397|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166398|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166399|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166400|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166401|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166402|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166403|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166404|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166405|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166406|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166407|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166408|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166409|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166410|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166411|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166412|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166746|NCT00395044|O2|Outcome|Placebo|Matched Placebo
1166413|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166414|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166415|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166416|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166417|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166418|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166419|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166420|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166421|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166422|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166423|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166424|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166425|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166426|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166427|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166428|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166429|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166430|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166431|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166432|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166433|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166434|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166435|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166436|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166437|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166438|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166439|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166440|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166441|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166442|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166443|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166444|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166445|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166446|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166447|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166448|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166449|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166450|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166747|NCT00395044|O1|Outcome|Gabapentin|1200 mg/daily of Gabapentin
1166451|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166452|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166453|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166454|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166455|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166456|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166457|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166458|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166459|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166460|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166461|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166462|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166463|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166464|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166465|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166466|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166467|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166468|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166469|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166470|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166471|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166472|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166473|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166474|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166475|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166476|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166477|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166478|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166479|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166480|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166481|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166482|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166483|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166484|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166485|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166486|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166487|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166488|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166748|NCT00395044|O2|Outcome|Placebo|Matched Placebo
1166489|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166490|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166491|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166492|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166493|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166494|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166495|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166496|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166497|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166498|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166499|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166500|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166501|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166502|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166503|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166504|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166505|NCT00395512|E4|Reported Event|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166506|NCT00395512|E3|Reported Event|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1166507|NCT00395512|E2|Reported Event|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1166508|NCT00395512|E1|Reported Event|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1166509|NCT00395486|B3|Baseline|Total|Total of all reporting groups
1166510|NCT00395486|B2|Baseline|Atorvastatin|10mg
1166511|NCT00395486|B1|Baseline|Rosuvastatin|10mg
1166512|NCT00395486|P2|Participant Flow|Atorvastatin|10mg
1166513|NCT00395486|P1|Participant Flow|Rosuvastatin|10mg
1166514|NCT00395486|O2|Outcome|Atorvastatin|10mg
1166515|NCT00395486|O1|Outcome|Rosuvastatin|10mg
1166516|NCT00395486|O2|Outcome|Atorvastatin|10mg
1166517|NCT00395486|O1|Outcome|Rosuvastatin|10mg
1166518|NCT00395486|O2|Outcome|Atorvastatin|10mg
1166519|NCT00395486|O1|Outcome|Rosuvastatin|10mg
1166520|NCT00395486|O2|Outcome|Atorvastatin|10mg
1166521|NCT00395486|O1|Outcome|Rosuvastatin|10mg
1166522|NCT00395486|O2|Outcome|Atorvastatin|10mg
1166523|NCT00395486|O1|Outcome|Rosuvastatin|10mg
1166524|NCT00395486|O2|Outcome|Atorvastatin|10mg
1166525|NCT00395486|O1|Outcome|Rosuvastatin|10mg
1166526|NCT00395486|O2|Outcome|Atorvastatin|10mg
1166527|NCT00395486|O1|Outcome|Rosuvastatin|10mg
1166528|NCT00395486|O2|Outcome|Atorvastatin|10mg
1166529|NCT00395486|O1|Outcome|Rosuvastatin|10mg
1166530|NCT00395486|O2|Outcome|Atorvastatin|10mg
1166531|NCT00395486|O1|Outcome|Rosuvastatin|10mg
1166532|NCT00395486|O2|Outcome|Atorvastatin|10mg
1166533|NCT00395486|O1|Outcome|Rosuvastatin|10mg
1166534|NCT00395486|O2|Outcome|Atorvastatin|10mg
1166535|NCT00395486|O1|Outcome|Rosuvastatin|10mg
1166536|NCT00395486|O2|Outcome|Atorvastatin|10mg
1166537|NCT00395486|O1|Outcome|Rosuvastatin|10mg
1166538|NCT00395486|E2|Reported Event|Atorvastatin|10mg
1166539|NCT00395486|E1|Reported Event|Rosuvastatin|10mg
1166540|NCT00395460|B3|Baseline|Total|Total of all reporting groups
1166541|NCT00395460|B2|Baseline|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
1166542|NCT00395460|B1|Baseline|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
1166543|NCT00395460|P2|Participant Flow|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
1166544|NCT00395460|P1|Participant Flow|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
1166545|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
1166546|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
1166547|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
1166548|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
1166549|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
1166550|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
1166551|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
1166552|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
1166553|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
1166554|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
1166555|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
1166556|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
1166557|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
1166558|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
1166559|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
1166560|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
1166561|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
1166562|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
1166563|NCT00395460|E2|Reported Event|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
1166564|NCT00395460|E1|Reported Event|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
1166565|NCT00395447|B3|Baseline|Total|Total of all reporting groups
1166566|NCT00395447|B2|Baseline|Replacement With Planned System Modification|Cohort for patients undergoing device replacement that includes a planned lead addition or revision. The complication rate is defined as the percentage of patients experiencing one or more major complication.
1166567|NCT00395447|B1|Baseline|'Straight-forward' Device Replacement|Cohort for patients undergoing a straight-forward device replacement without any planned system modification
1166568|NCT00395447|P2|Participant Flow|Replacement With Planned System Modification|Cohort for patients undergoing device replacement that includes a planned lead addition or revision. The complication rate is defined as the percentage of patients experiencing one or more major complication.
1166569|NCT00395447|P1|Participant Flow|'Straight-forward' Device Replacement|Cohort for patients undergoing a straight-forward device replacement without any planned system modification
1166570|NCT00395447|O2|Outcome|Replacement With Planned System Modification|Cohort for patients undergoing device replacement that includes a planned lead addition or revision. The complication rate is defined as the percentage of patients experiencing one or more major complication.
1166571|NCT00395447|O1|Outcome|'Straight-forward' Device Replacement|Cohort for patients undergoing a straight-forward device replacement without any planned system modification
1166572|NCT00395447|E2|Reported Event|Replacement With Planned System Modification|Cohort for patients undergoing device replacement that includes a planned lead addition or revision. The complication rate is defined as the percentage of patients experiencing one or more major complication.
1166573|NCT00395447|E1|Reported Event|'Straight-forward' Device Replacement|Cohort for patients undergoing a straight-forward device replacement without any planned system modification
1166574|NCT00395343|B3|Baseline|Total|Total of all reporting groups
1166575|NCT00395343|B2|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
1166576|NCT00395343|B1|Baseline|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
1166577|NCT00395343|P2|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
1166578|NCT00395343|P1|Participant Flow|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
1166579|NCT00395343|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
1166580|NCT00395343|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
1166581|NCT00395343|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
1166582|NCT00395343|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
1166583|NCT00395343|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
1166584|NCT00395343|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
1166585|NCT00395343|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
1166586|NCT00395343|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
1166587|NCT00395343|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
1166588|NCT00395343|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
1166589|NCT00395343|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
1166590|NCT00395343|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
1166591|NCT00395343|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
1166592|NCT00395343|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
1166593|NCT00395343|E2|Reported Event|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
1166594|NCT00395343|E1|Reported Event|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
1166595|NCT00395304|B1|Baseline|All Participants|All participants randomized to the six crossover sequences
1166596|NCT00395304|P6|Participant Flow|1xICS + LTRA, 1xICS + LABA, 2xICS|Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck), followed by Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)
1166597|NCT00395304|P5|Participant Flow|1xICS + LTRA, 2xICS, 1xICS + LABA|Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck), followed by Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)
1166654|NCT00395161|O1|Outcome|Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide|
1166655|NCT00395161|O2|Outcome|Whey Protein|Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.
1166598|NCT00395304|P4|Participant Flow|1xICS + LABA, 1xICS + LTRA, 2xICS|Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck), followed by Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)
1166599|NCT00395304|P3|Participant Flow|1xICS +LABA, 2xICS, 1xICS + LTRA|Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
1166600|NCT00395304|P2|Participant Flow|2xICS, 1xICS + LTRA, 1xICS + LABA|Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck), followed by Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)
1166601|NCT00395304|P1|Participant Flow|2xICS, 1xICS + LABA, 1xICS + LTRA|Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
1166602|NCT00395304|O1|Outcome|All Participants|All participants randomized to the six crossover sequences
1166603|NCT00395304|E1|Reported Event|All Participants|All participants randomized to the six crossover sequences
1166604|NCT00395291|B1|Baseline|Entire Study Population|Includes groups randomized to placebo first and MK-0677 first.
1166605|NCT00395291|P2|Participant Flow|Placebo First, Then MK-0677|Subjects took Placebo for at least 30 days.
1166606|NCT00395291|P1|Participant Flow|MK-0677 First, Then Placebo|Subjects took 25mg of MK-0677 for at least 30 Days.
1166607|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
1166608|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
1166609|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
1166610|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
1166611|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
1166612|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
1166613|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
1166614|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
1166615|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
1166616|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
1166617|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
1166618|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
1166619|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
1166620|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
1166621|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
1166622|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
1166623|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
1166624|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
1166625|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
1166626|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
1166627|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
1166628|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
1166629|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
1166630|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
1166631|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
1166632|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
1166633|NCT00395291|E2|Reported Event|Placebo|Subjects took Placebo for at least 30 days.
1166634|NCT00395291|E1|Reported Event|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
1166635|NCT00395226|B3|Baseline|Total|Total of all reporting groups
1166636|NCT00395226|B2|Baseline|Zinc Sulfate|
1166637|NCT00395226|B1|Baseline|Placebo (Lactose)|
1166638|NCT00395226|P2|Participant Flow|Zinc Sulfate|
1166639|NCT00395226|P1|Participant Flow|Placebo (Lactose)|
1166640|NCT00395226|O2|Outcome|Zinc Sulfate|
1166641|NCT00395226|O1|Outcome|Placebo (Lactose)|
1166642|NCT00395226|E2|Reported Event|Zinc Sulfate|
1166643|NCT00395226|E1|Reported Event|Placebo (Lactose)|
1166644|NCT00395161|B3|Baseline|Total|Total of all reporting groups
1166645|NCT00395161|B2|Baseline|Whey Protein|Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.
1166646|NCT00395161|B1|Baseline|Daily Nutriceutical Supplementation|Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.
1166647|NCT00395161|P2|Participant Flow|Enteral Whey Protein, IV Saline|Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.
1166648|NCT00395161|P1|Participant Flow|Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide|Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.
1166649|NCT00395161|O2|Outcome|Enteral Whey Protein, IV Saline|
1166650|NCT00395161|O1|Outcome|Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide|
1166651|NCT00395161|O2|Outcome|Enteral Whey Protein, IV Saline|
1166652|NCT00395161|O1|Outcome|Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide|
1166653|NCT00395161|O2|Outcome|Enteral Whey Protein, IV Saline|
1166656|NCT00395161|O1|Outcome|Daily Nutriceutical Supplementation|Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.
1166657|NCT00395161|O2|Outcome|Whey Protein|Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.
1166658|NCT00395161|O1|Outcome|Daily Nutriceutical Supplementation|Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.
1166659|NCT00395161|E2|Reported Event|Whey Protein|Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.
1166660|NCT00395161|E1|Reported Event|Daily Nutriceutical Supplementation|Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.
1166661|NCT00395135|B3|Baseline|Total|Total of all reporting groups
1166662|NCT00395135|B2|Baseline|Year 1 - Matching Placebo BID|matching placebo tablets
1166663|NCT00395135|B1|Baseline|Year 1 - Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
1166664|NCT00395135|P5|Participant Flow|Year 2 - Placebo (Yr 1) / Placebo (Yr 2)|Patients randomized to placebo in Year 1, completed year 1 and randomized to receive placebo in Year 2.
1166665|NCT00395135|P4|Participant Flow|Year 2 - Lorc 10 mg BID (Yr 1) / Placebo (Yr 2)|Patients were randomized to lorcaserin in Year 1, completed year 1 study and randomized to placebo in Year 2.
1166666|NCT00395135|P3|Participant Flow|Year 2 - Lorc 10 mg BID (Yr 1) / Lorc 10 mg BID (Yr 2)|Patients were randomized to lorcaserin in Year 1, completed year 1 study and randomized to lorcaserin in Year 2.
1166667|NCT00395135|P2|Participant Flow|Year 1 - Matching Placebo BID|matching placebo tablets
1166668|NCT00395135|P1|Participant Flow|Year 1 - Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
1166669|NCT00395135|O3|Outcome|Placebo (Yr 1) / Placebo (Yr 2)|Patients were randomized to placebo in Year 1 and randomized to placebo in Year 2.
1166670|NCT00395135|O2|Outcome|Lorcaserin 10 mg BID (Yr 1) / Matching Placebo (Yr 2)|Patients were randomized to lorcaserin in Year 1, completed year 1 study and randomized to placebo in Year 2.
1166671|NCT00395135|O1|Outcome|Lorcaserin 10 mg BID (Yr 1) / Lorcaserin 10 mg BID (Yr 2)|Patients were randomized to lorcaserin in Year 1, completed year 1 study and randomized to lorcaserin in Year 2.
1166672|NCT00395135|O2|Outcome|Matching Placebo BID|matching placebo tablets
1166673|NCT00395135|O1|Outcome|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
1166674|NCT00395135|O2|Outcome|Lorcaserin 10 mg BID (Yr 1) / Matching Placebo (Yr 2)|"Patients were randomized to lorcaserin in Year 1, completed year 1 with a Responder status and randomized to placebo in Year 2."
1166675|NCT00395135|O1|Outcome|Lorcaserin 10 mg BID (Yr 1) / Lorcaserin 10 mg BID (Yr 2)|"Patients were randomized to lorcaserin in Year 1, completed year 1 study with a Responder status and randomized to lorcaserin in Year 2."
1166676|NCT00395135|O2|Outcome|Matching Placebo BID|matching placebo tablets
1166677|NCT00395135|O1|Outcome|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
1166678|NCT00395135|E5|Reported Event|Year 2 - Placebo (Yr 1) / Placebo (Yr 2)|matching placebo tablets
1166679|NCT00395135|E4|Reported Event|Year 2 - Lorc 10 mg BID (Yr 1) / Matching Placebo (Yr 2)|lorcaserin 10 mg BID tablets, matching placebo tablets
1166680|NCT00395135|E3|Reported Event|Year 2 - Lorc 10 mg BID (Yr 1) / Lorc 10 mg BID (Yr 2)|lorcaserin 10 mg BID tablets
1166681|NCT00395135|E2|Reported Event|Year 1 - Matching Placebo BID|matching placebo tablets
1166682|NCT00395135|E1|Reported Event|Year 1 - Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
1166683|NCT00395083|B3|Baseline|Total|Total of all reporting groups
1166684|NCT00395083|B2|Baseline|Comprehensive Care Management Program|"The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.~COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs."
1166685|NCT00395083|B1|Baseline|Usual Care|Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
1166686|NCT00395083|P2|Participant Flow|Comprehensive Care Management Program|"The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.~COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs."
1166687|NCT00395083|P1|Participant Flow|Usual Care|Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
1166688|NCT00395083|O2|Outcome|Comprehensive Care Management Program|"The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.~COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs."
1166689|NCT00395083|O1|Outcome|Usual Care|Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
1166737|NCT00395044|O1|Outcome|Gabapentin|1200 mg/daily of Gabapentin
1166738|NCT00395044|O2|Outcome|Placebo|Matched Placebo
1166690|NCT00395083|O2|Outcome|Comprehensive Care Management Program|"The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.~COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs."
1166691|NCT00395083|O1|Outcome|Usual Care|Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
1166692|NCT00395083|O2|Outcome|Comprehensive Care Management Program|"The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.~COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs."
1166693|NCT00395083|O1|Outcome|Usual Care|Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
1166694|NCT00395083|O2|Outcome|Comprehensive Care Management Program|"The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.~COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs."
1166695|NCT00395083|O1|Outcome|Usual Care|Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
1166696|NCT00395083|E2|Reported Event|Comprehensive Care Management Program|"The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.~COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs."
1166697|NCT00395083|E1|Reported Event|Usual Care|Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
1166698|NCT00395057|B5|Baseline|Total|Total of all reporting groups
1166699|NCT00395057|B4|Baseline|Ranibizumab 500 ug|Ranibizumab 500 ug
1166700|NCT00395057|B3|Baseline|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
1166701|NCT00395057|B2|Baseline|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
1166702|NCT00395057|B1|Baseline|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
1166703|NCT00395057|P4|Participant Flow|Ranibizumab 500 ug|Ranibizumab 500 ug
1166704|NCT00395057|P3|Participant Flow|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
1166705|NCT00395057|P2|Participant Flow|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
1166706|NCT00395057|P1|Participant Flow|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
1166707|NCT00395057|O4|Outcome|Ranibizumab 500 ug|Ranibizumab 500 ug
1166708|NCT00395057|O3|Outcome|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
1166709|NCT00395057|O2|Outcome|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
1166710|NCT00395057|O1|Outcome|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
1166711|NCT00395057|O4|Outcome|Ranibizumab 500 ug|Ranibizumab 500 ug
1166712|NCT00395057|O3|Outcome|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
1166713|NCT00395057|O2|Outcome|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
1166714|NCT00395057|O1|Outcome|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
1166715|NCT00395057|O4|Outcome|Ranibizumab 500 ug|Ranibizumab 500 ug
1166716|NCT00395057|O3|Outcome|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
1166717|NCT00395057|O2|Outcome|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
1166718|NCT00395057|O1|Outcome|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
1166719|NCT00395057|O4|Outcome|Ranibizumab 500 ug|Ranibizumab 500 ug
1166720|NCT00395057|O3|Outcome|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
1166721|NCT00395057|O2|Outcome|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
1166722|NCT00395057|O1|Outcome|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
1166723|NCT00395057|O4|Outcome|Ranibizumab 500 ug|Ranibizumab 500 ug
1166724|NCT00395057|O3|Outcome|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
1166725|NCT00395057|O2|Outcome|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
1166726|NCT00395057|O1|Outcome|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
1166727|NCT00395057|E4|Reported Event|Ranibizumab 500 ug|Ranibizumab 500 ug
1166728|NCT00395057|E3|Reported Event|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
1166729|NCT00395057|E2|Reported Event|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
1166730|NCT00395057|E1|Reported Event|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
1166731|NCT00395044|B3|Baseline|Total|Total of all reporting groups
1166732|NCT00395044|B2|Baseline|Placebo|1200mg/d of Placebo
1166733|NCT00395044|B1|Baseline|Gabapentin|1200 mg/daily of Gabapentin
1166734|NCT00395044|P2|Participant Flow|Placebo|Matched Placebo
1166735|NCT00395044|P1|Participant Flow|Gabapentin|1200 mg/daily of Gabapentin
1166736|NCT00395044|O2|Outcome|Placebo|Matched Placebo
1166750|NCT00395044|E2|Reported Event|Placebo|1200mg/d of Placebo
1166751|NCT00395044|E1|Reported Event|Gabapentin|1200 mg/daily of Gabapentin
1166752|NCT00395018|B1|Baseline|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
1166753|NCT00395018|P1|Participant Flow|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
1166754|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
1166755|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
1166756|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
1166757|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
1166758|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
1166759|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
1166760|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
1166761|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
1166762|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
1166763|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
1166764|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
1166765|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
1166766|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
1166767|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
1166768|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
1166769|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
1166770|NCT00395018|E1|Reported Event|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
1166771|NCT00394953|B3|Baseline|Total|Total of all reporting groups
1166772|NCT00394953|B2|Baseline|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
1166773|NCT00394953|B1|Baseline|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
1166774|NCT00394953|P2|Participant Flow|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 to Week 52.
1166775|NCT00394953|P1|Participant Flow|MIRCERA|Participants with anemia in chronic kidney disease (CKD) who were on hemodialysis received methoxy polyethylene glycol-epoetin beta (MIRCERA [RO0503821]) intravenously (IV) once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 microgram per month (mcg/month) for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
1166776|NCT00394953|O2|Outcome|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
1166777|NCT00394953|O1|Outcome|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
1166778|NCT00394953|O2|Outcome|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
1166779|NCT00394953|O1|Outcome|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
1166780|NCT00394953|O2|Outcome|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
1166781|NCT00394953|O1|Outcome|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
1166782|NCT00394953|O2|Outcome|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
1166783|NCT00394953|O1|Outcome|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
1166784|NCT00394953|O2|Outcome|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
1166819|NCT00394901|B4|Baseline|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1168030|NCT00392678|O3|Outcome|Salsalate 3.5 g/d|Salsalate 3.5 g/d, divided
1166785|NCT00394953|O1|Outcome|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
1166786|NCT00394953|O2|Outcome|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
1166787|NCT00394953|O1|Outcome|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
1166788|NCT00394953|E2|Reported Event|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
1166789|NCT00394953|E1|Reported Event|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
1166790|NCT00394914|B3|Baseline|Total|Total of all reporting groups
1166791|NCT00394914|B2|Baseline|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
1166792|NCT00394914|B1|Baseline|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
1166793|NCT00394914|P3|Participant Flow|Placebo|Participants were randomized to receive placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
1166794|NCT00394914|P2|Participant Flow|Pleconaril|Participants were randomized to receive Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
1166795|NCT00394914|P1|Participant Flow|All Participants (Pre-randomization)|All participants on study prior to randomization.
1166796|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
1166797|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
1166798|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
1166799|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
1166800|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
1166801|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
1166802|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
1166803|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
1166804|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
1166805|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
1166806|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
1166807|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
1166808|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
1166809|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
1166810|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
1166811|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
1166812|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
1166813|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
1166814|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
1166815|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
1166816|NCT00394914|E2|Reported Event|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
1166817|NCT00394914|E1|Reported Event|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
1166818|NCT00394901|B5|Baseline|Total|Total of all reporting groups
1166820|NCT00394901|B3|Baseline|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166821|NCT00394901|B2|Baseline|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166822|NCT00394901|B1|Baseline|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166823|NCT00394901|P4|Participant Flow|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166824|NCT00394901|P3|Participant Flow|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166825|NCT00394901|P2|Participant Flow|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166826|NCT00394901|P1|Participant Flow|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166827|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166828|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166829|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166830|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166831|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166832|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166833|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166834|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166835|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166836|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166837|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166838|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166839|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166840|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166841|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166842|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166843|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166844|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166845|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166846|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166847|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166848|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166849|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166850|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166851|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166852|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166853|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166854|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166855|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166856|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166857|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166858|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166859|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166860|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166861|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166862|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166863|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166864|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166865|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166866|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166867|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166868|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166869|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166870|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166871|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166872|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166873|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166874|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166875|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166876|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166877|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166878|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166879|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166880|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166881|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166882|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166883|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166884|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166885|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166886|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166887|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166888|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166889|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166890|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166891|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166892|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166893|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166894|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166895|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166896|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166897|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166898|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166899|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166900|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166901|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166902|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166903|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166904|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166905|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166906|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166907|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166908|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166909|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166910|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166911|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166912|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166913|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166914|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166915|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166916|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166917|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166918|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166919|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166920|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166921|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166922|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166923|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166924|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166925|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166926|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166927|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166928|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166929|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166930|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166931|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166932|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166933|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166934|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166935|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166936|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166937|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166938|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166939|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166940|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166941|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166942|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166943|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166944|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166945|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166946|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166947|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166948|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166949|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166950|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166951|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166952|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166953|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166954|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166955|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166956|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166957|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166958|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166959|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166960|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166961|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166962|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166963|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166964|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166965|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166966|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166967|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166968|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166969|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166970|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166971|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166972|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166973|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166974|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166975|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166976|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166977|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166978|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166979|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166980|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166981|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166982|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166983|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166984|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1168017|NCT00392678|O4|Outcome|Salsalate 4.0 g/d|Salsalate 4.0 g/d, divided
1166985|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166986|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166987|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166988|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166989|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166990|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166991|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166992|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166993|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166994|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166995|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1166996|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1166997|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1166998|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1166999|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1167000|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1167001|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1167002|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1167003|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1167004|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1167005|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1167006|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1167007|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1167008|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1167009|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1167010|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1167011|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1167012|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1167013|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1167014|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1167015|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1167016|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1167017|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1167018|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1167019|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1167020|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1167021|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1167022|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1167023|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1167024|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1167025|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1167026|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1167027|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1167028|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1167029|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1167030|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1167031|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1167032|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1167033|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1167034|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1167035|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1167036|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1167037|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1167038|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1167039|NCT00394901|O3|Outcome|Expected Pregabalin Exposure of 600 mg/Day|Subjects with low CLcr (> 30 and <= 60 mL/min) who received pregabalin 300 mg/day and subjects who received pregabalin 600 mg/day.
1167040|NCT00394901|O2|Outcome|Expected Pregabalin Exposure of 300 mg/Day|Subjects with low CLcr (> 30 and <= 60 mL/min) who received pregabalin 150 mg/day and subjects with normal CLcr (> 60 mL/min) who received pregabalin 300 mg/day.
1167041|NCT00394901|O1|Outcome|Placebo|Subjects who received matching placebo during a 13-week double-blind treatment phase.
1167042|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1167043|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1167044|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1167045|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1167046|NCT00394901|E4|Reported Event|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
1167047|NCT00394901|E3|Reported Event|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
1167048|NCT00394901|E2|Reported Event|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
1167049|NCT00394901|E1|Reported Event|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
1167050|NCT00394888|B4|Baseline|Total|Total of all reporting groups
1167051|NCT00394888|B3|Baseline|Multiple Hemangiomas|Patients with multiple hemangiomas
1167052|NCT00394888|B2|Baseline|Lumbosacral Hemangioma|Patients with lumbosacral hemangioma.
1167053|NCT00394888|B1|Baseline|Facial Hemangioma|Patients with large facial hemangioma.
1167054|NCT00394888|P3|Participant Flow|Multiple Hemangiomas|Patients with multiple hemangiomas
1167055|NCT00394888|P2|Participant Flow|Lumbosacral Hemangioma|Patients with lumbosacral hemangioma.
1167056|NCT00394888|P1|Participant Flow|Facial Hemangioma|Patients with large facial hemangioma.
1167057|NCT00394888|O1|Outcome|All Participants|entire population count for MRI/A
1167058|NCT00394888|O1|Outcome|All Participants|entire population count for MRI/A
1167059|NCT00394888|O1|Outcome|All Participants|entire population count for MRI/A
1167060|NCT00394888|O1|Outcome|All Participants|entire population count for MRI/A
1167061|NCT00394888|O1|Outcome|All Participants|entire population count for MRI/A
1167062|NCT00394888|O1|Outcome|All Participants|entire population count for MRI/A
1167063|NCT00394888|E3|Reported Event|Multiple Hemangiomas|Patients with multiple hemangiomas
1167064|NCT00394888|E2|Reported Event|Lumbosacral Hemangioma|Patients with lumbosacral hemangioma.
1167065|NCT00394888|E1|Reported Event|Facial Hemangioma|Patients with large facial hemangioma.
1167066|NCT00394836|B3|Baseline|Total|Total of all reporting groups
1167067|NCT00394836|B2|Baseline|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
1167068|NCT00394836|B1|Baseline|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
1167069|NCT00394836|P2|Participant Flow|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions. In the extended follow-up phase of the study, participants were followed only for survival status for up to 5 years and new Follicular lymphoma (FL) treatment. Time to the next FL treatment analysis included participants which received new FL treatment during extended follow-up.
1167070|NCT00394836|P1|Participant Flow|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions. In the extended follow-up phase of the study, participants were followed only for survival status for up to 5 years and new follicular lymphoma (FL) treatment. Time to the next FL treatment analysis included participants which received new FL treatment during extended follow-up.
1167268|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
1167071|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
1167072|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
1167073|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
1167074|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
1167075|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
1167076|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
1167077|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
1167078|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
1167079|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
1167080|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
1167081|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
1167082|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
1167083|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
1167084|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
1167085|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
1167086|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
1167087|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
1167088|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
1167089|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
1167090|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
1167091|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
1167092|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
1167093|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
1167094|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
1167095|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
1167096|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
1167097|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
1167098|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
1167099|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
1167100|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
1167101|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
1167102|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
1167103|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
1167104|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
1167105|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
1167106|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
1167107|NCT00394836|E4|Reported Event|Ofatumumab 1000 mg: Extended Follow-up Phase|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions. In the extended follow-up phase of the study, participants were followed only for survival status for up to 5 years and new Follicular lymphoma (FL) treatment. Time to the next FL treatment analysis included participants which received new FL treatment during extended follow-up.
1167108|NCT00394836|E3|Reported Event|Ofatumumab 500 mg: Extended Follow-up Phase|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions. In the extended follow-up phase of the study, participants were followed only for survival status for up to 5 years and new follicular lymphoma (FL) treatment. Time to the next FL treatment analysis included participants which received new FL treatment during extended follow-up.
1167109|NCT00394836|E2|Reported Event|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
1167110|NCT00394836|E1|Reported Event|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
1167111|NCT00394771|B5|Baseline|Total|Total of all reporting groups
1167112|NCT00394771|B4|Baseline|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
1167113|NCT00394771|B3|Baseline|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167114|NCT00394771|B2|Baseline|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167115|NCT00394771|B1|Baseline|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167116|NCT00394771|P4|Participant Flow|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
1167117|NCT00394771|P3|Participant Flow|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167118|NCT00394771|P2|Participant Flow|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167119|NCT00394771|P1|Participant Flow|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167120|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
1167121|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167122|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167123|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167124|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
1167125|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167126|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167127|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167128|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
1167129|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167130|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167131|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167132|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
1167133|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167134|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167135|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167136|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
1167137|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167138|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167139|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167140|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
1167141|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167142|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167143|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167144|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
1167145|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167146|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167147|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167148|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
1167149|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167150|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167151|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167152|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
1167153|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167154|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167155|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167156|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
1167157|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167158|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167159|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167160|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
1167161|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167162|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167269|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
1167270|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
1167163|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167164|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
1167165|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167166|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167167|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167168|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
1167169|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167170|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167171|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167172|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
1167173|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167174|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167175|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167176|NCT00394771|E4|Reported Event|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
1167177|NCT00394771|E3|Reported Event|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167178|NCT00394771|E2|Reported Event|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167179|NCT00394771|E1|Reported Event|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
1167180|NCT00394706|B9|Baseline|Total|Total of all reporting groups
1167181|NCT00394706|B8|Baseline|Not in AEvAL, Sham|Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Sham ITD used by EMS providers in the pre-hospital setting.
1167182|NCT00394706|B7|Baseline|Not in AEvAL, ITD Device|Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Impedance Threshold Device used by EMS providers in the pre-hospital setting.
1167183|NCT00394706|B6|Baseline|Analyze Later, Not in ITD vs. Sham|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.
1167184|NCT00394706|B5|Baseline|Analyze Later + Sham|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.
1167185|NCT00394706|B4|Baseline|Analyze Later + ITD|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.
1167186|NCT00394706|B3|Baseline|Analyze Early, Not in ITD vs Sham|Analyze early. Upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.
1167187|NCT00394706|B2|Baseline|Analyze Early + Sham|Analyze early: upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.
1167271|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
1167272|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
1167188|NCT00394706|B1|Baseline|Analyze Early + ITD|Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR (cardiopulmonary resuscitation) may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of ITD (Impedance Threshold Device) by EMS providers in the prehospital setting.
1167189|NCT00394706|P8|Participant Flow|Not in AEvAL, Sham|Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Sham ITD used by EMS providers in the pre-hospital setting.
1167190|NCT00394706|P7|Participant Flow|Not in AEvAL, ITD Device|Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Impedance Threshold Device used by EMS providers in the pre-hospital setting.
1167191|NCT00394706|P6|Participant Flow|Analyze Later, Not in ITD vs. Sham|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.
1167192|NCT00394706|P5|Participant Flow|Analyze Later + Sham|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.
1167193|NCT00394706|P4|Participant Flow|Analyze Later + ITD|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.
1167194|NCT00394706|P3|Participant Flow|Analyze Early, Not in ITD vs Sham|Analyze early. Upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.
1167195|NCT00394706|P2|Participant Flow|Analyze Early + Sham|Analyze early: upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.
1167196|NCT00394706|P1|Participant Flow|Analyze Early + ITD|Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR (cardiopulmonary resuscitation) may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of ITD (Impedance Threshold Device) by EMS providers in the prehospital setting.
1167197|NCT00394706|O4|Outcome|Sham ITD|Sham ITD used by EMS providers in the pre-hospital setting.
1167198|NCT00394706|O3|Outcome|Active ITD|Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.
1167199|NCT00394706|O2|Outcome|Analyze Later|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.
1167200|NCT00394706|O1|Outcome|Analyze Early|Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.
1167201|NCT00394706|O4|Outcome|Sham ITD|Sham ITD used by EMS providers in the pre-hospital setting.
1167202|NCT00394706|O3|Outcome|Active ITD|Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.
1167203|NCT00394706|O2|Outcome|Analyze Later|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.
1167204|NCT00394706|O1|Outcome|Analyze Early|Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.
1167205|NCT00394706|E8|Reported Event|Not in AEvAL, Sham|Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Sham ITD used by EMS providers in the pre-hospital setting.
1167206|NCT00394706|E7|Reported Event|Not in AEvAL, ITD Device|Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Impedance Threshold Device used by EMS providers in the pre-hospital setting.
1167207|NCT00394706|E6|Reported Event|Analyze Later, Not in ITD vs. Sham|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.
1167208|NCT00394706|E5|Reported Event|Analyze Later + Sham|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.
1167209|NCT00394706|E4|Reported Event|Analyze Later + ITD|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.
1167210|NCT00394706|E3|Reported Event|Analyze Early, Not in ITD vs Sham|Analyze early. Upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.
1167211|NCT00394706|E2|Reported Event|Analyze Early + Sham|Analyze early: upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.
1167212|NCT00394706|E1|Reported Event|Analyze Early + ITD|Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR (cardiopulmonary resuscitation) may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of ITD (Impedance Threshold Device) by EMS providers in the prehospital setting.
1167213|NCT00394654|B3|Baseline|Total|Total of all reporting groups
1167214|NCT00394654|B2|Baseline|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
1167215|NCT00394654|B1|Baseline|PLACEBO|
1167216|NCT00394654|P2|Participant Flow|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
1167217|NCT00394654|P1|Participant Flow|PLACEBO|
1167218|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
1167219|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
1167220|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
1167221|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
1167222|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
1167223|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
1167224|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
1167225|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
1167226|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
1167227|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
1167228|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
1167229|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
1167230|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
1167231|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
1167232|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
1167233|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
1167234|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
1167235|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
1167236|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
1167237|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
1167238|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
1167239|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
1167240|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
1167241|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
1167242|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
1167243|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
1167244|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
1167245|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
1167246|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
1167247|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
1167248|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
1167249|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
1167250|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
1167251|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
1167252|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
1167253|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
1167254|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
1167255|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
1167256|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
1167257|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
1167258|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
1167259|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
1167260|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
1167261|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
1167262|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
1167263|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
1167264|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
1167265|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
1167266|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
1167267|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
1167273|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
1167274|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
1167275|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
1167276|NCT00394654|E2|Reported Event|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
1167277|NCT00394654|E1|Reported Event|PLACEBO|
1167278|NCT00394589|B4|Baseline|Total|Total of all reporting groups
1167279|NCT00394589|B3|Baseline|Control|Continuation of infliximab 3 mg/kg every 8 weeks
1167280|NCT00394589|B2|Baseline|Increased Frequency|Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks
1167281|NCT00394589|B1|Baseline|Increased Dose|3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks
1167282|NCT00394589|P3|Participant Flow|Control|Continuation of infliximab 3 mg/kg every 8 weeks
1167283|NCT00394589|P2|Participant Flow|Increased Frequency|Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks
1167284|NCT00394589|P1|Participant Flow|Increased Dose|3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks
1167285|NCT00394589|O3|Outcome|Control|Continuation of infliximab 3 mg/kg every 8 weeks
1167286|NCT00394589|O2|Outcome|Increased Frequency|Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks
1167287|NCT00394589|O1|Outcome|Increased Dose|3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks
1167288|NCT00394589|E3|Reported Event|Control*Infliximab*3mg/kg Q8W|
1167289|NCT00394589|E2|Reported Event|Infliximab*3mg/kg Q6W|
1167290|NCT00394589|E1|Reported Event|Infliximab*3mg/kg+1*Vial Q8W|
1167291|NCT00394524|B3|Baseline|Total|Total of all reporting groups
1167292|NCT00394524|B2|Baseline|Standard Insulin Infusion|standard insulin infusion with columnar algorithm
1167293|NCT00394524|B1|Baseline|Glucommander|insulin infusion per Glucommander
1167294|NCT00394524|P2|Participant Flow|Standard Insulin Infusion|standard continuous insulin infusion with columnar algorithm; dosage or rate of insulin per algorithm
1167295|NCT00394524|P1|Participant Flow|Glucommander|continuous insulin infusion per Glucommander, a computer-guided device; dosage or rate of insulin per algorithm
1167296|NCT00394524|O2|Outcome|Standard Insulin Infusion|standard insulin infusion with columnar algorithm
1167297|NCT00394524|O1|Outcome|Glucommander|insulin infusion per Glucommander
1167298|NCT00394524|O2|Outcome|Standard Insulin Infusion|standard insulin infusion with columnar algorithm
1167299|NCT00394524|O1|Outcome|Glucommander|insulin infusion per Glucommander
1167300|NCT00394524|O2|Outcome|Standard Insulin Infusion|standard insulin infusion with columnar algorithm
1167301|NCT00394524|O1|Outcome|Glucommander|insulin infusion per Glucommander
1167302|NCT00394524|E2|Reported Event|Standard Insulin Infusion|standard insulin infusion with columnar algorithm
1167303|NCT00394524|E1|Reported Event|Glucommander|insulin infusion per Glucommander
1167304|NCT00394472|B3|Baseline|Total|Total of all reporting groups
1167305|NCT00394472|B2|Baseline|Placebo|Placebo capsules bid
1167306|NCT00394472|B1|Baseline|AZD3355|AZD3355 capsules 65 mg bid
1167307|NCT00394472|P2|Participant Flow|Placebo|Placebo capsules bid
1167308|NCT00394472|P1|Participant Flow|AZD3355|AZD3355 capsules 65 mg bid
1167309|NCT00394472|O2|Outcome|Placebo|Placebo capsules bid
1167310|NCT00394472|O1|Outcome|AZD3355|AZD3355 capsules 65 mg bid
1167311|NCT00394472|O2|Outcome|Placebo|Placebo capsules bid
1167312|NCT00394472|O1|Outcome|AZD3355|AZD3355 capsules 65 mg bid
1167313|NCT00394472|E2|Reported Event|Placebo|Placebo capsules bid
1167314|NCT00394472|E1|Reported Event|AZD3355|AZD3355 capsules 65 mg bid
1167315|NCT00394433|B1|Baseline|Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)|Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
1167316|NCT00394433|P1|Participant Flow|Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)|Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
1167317|NCT00394433|O1|Outcome|Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)|Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
1167318|NCT00394433|O1|Outcome|Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)|Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
1167392|NCT00394277|O1|Outcome|PEG-IFN 180 µg + Ribavirin 1200 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
1167319|NCT00394433|O1|Outcome|Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)|Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
1167320|NCT00394433|O1|Outcome|Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)|Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
1167321|NCT00394433|E1|Reported Event|Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)|Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
1167322|NCT00394355|B5|Baseline|Total|Total of all reporting groups
1167323|NCT00394355|B4|Baseline|ML 10 mg QD PM|Montelukast (ML) 10 mg QD PM for 1 year
1167324|NCT00394355|B3|Baseline|FP MDI 250 mcg BID|Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
1167325|NCT00394355|B2|Baseline|MF DPI 400 mcg QD PM|MF DPI 400 mcg QD PM for 1 year
1167326|NCT00394355|B1|Baseline|MF DPI 200 mcg QD PM|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
1167327|NCT00394355|P4|Participant Flow|ML 10 mg QD PM|Montelukast (ML) 10 mg QD PM for 1 year
1167328|NCT00394355|P3|Participant Flow|FP MDI 250 mcg BID|Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
1167329|NCT00394355|P2|Participant Flow|MF DPI 400 mcg QD PM|MF DPI 400 mcg QD PM for 1 year
1167330|NCT00394355|P1|Participant Flow|MF DPI 200 mcg QD PM|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
1167331|NCT00394355|O4|Outcome|ML 10 mg QD PM|Montelukast (ML) 10 mg QD PM for 1 year
1167332|NCT00394355|O3|Outcome|FP MDI 250 mcg BID|Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
1167333|NCT00394355|O2|Outcome|MF DPI 400 mcg QD PM|MF DPI 400 mcg QD PM for 1 year
1167334|NCT00394355|O1|Outcome|MF DPI 200 mcg QD PM|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
1167335|NCT00394355|O4|Outcome|ML 10 mg QD PM|Montelukast (ML) 10 mg QD PM for 1 year
1167336|NCT00394355|O3|Outcome|FP MDI 250 mcg BID|Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
1167337|NCT00394355|O2|Outcome|MF DPI 400 mcg QD PM|MF DPI 400 mcg QD PM for 1 year
1167338|NCT00394355|O1|Outcome|MF DPI 200 mcg QD PM|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
1167339|NCT00394355|O4|Outcome|ML 10 mg QD PM|Montelukast (ML) 10 mg QD PM for 1 year
1167340|NCT00394355|O3|Outcome|FP MDI 250 mcg BID|Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
1167341|NCT00394355|O2|Outcome|MF DPI 400 mcg QD PM|MF DPI 400 mcg QD PM for 1 year
1167342|NCT00394355|O1|Outcome|MF DPI 200 mcg QD PM|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
1167343|NCT00394355|O4|Outcome|ML 10 mg QD PM|Montelukast (ML) 10 mg QD PM for 1 year
1167344|NCT00394355|O3|Outcome|FP MDI 250 mcg BID|Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
1167345|NCT00394355|O2|Outcome|MF DPI 400 mcg QD PM|MF DPI 400 mcg QD PM for 1 year
1167346|NCT00394355|O1|Outcome|MF DPI 200 mcg QD PM|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
1167347|NCT00394355|E4|Reported Event|ML 10 mg QD PM|Montelukast (ML) 10 mg QD PM for 1 year
1167348|NCT00394355|E3|Reported Event|FP MDI 250 mcg BID|Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
1167349|NCT00394355|E2|Reported Event|MF DPI 400 mcg QD PM|MF DPI 400 mcg QD PM for 1 year
1167350|NCT00394355|E1|Reported Event|MF DPI 200 mcg QD PM|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
1167351|NCT00394329|B5|Baseline|Total|Total of all reporting groups
1167352|NCT00394329|B4|Baseline|D: Placebo|"Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
1167353|NCT00394329|B3|Baseline|C: Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
1167354|NCT00394329|B2|Baseline|B: Daily ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
1167425|NCT00394251|E1|Reported Event|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
1167426|NCT00394212|B3|Baseline|Total|Total of all reporting groups
1167355|NCT00394329|B1|Baseline|A: Daily ICS + Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
1167356|NCT00394329|P4|Participant Flow|D: Placebo|"Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
1167357|NCT00394329|P3|Participant Flow|C: Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
1167358|NCT00394329|P2|Participant Flow|B: Daily ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
1167359|NCT00394329|P1|Participant Flow|A: Daily ICS + Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate : Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
1167360|NCT00394329|O4|Outcome|D: Placebo|"Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
1167361|NCT00394329|O3|Outcome|C: Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
1167362|NCT00394329|O2|Outcome|B: Daily ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
1167363|NCT00394329|O1|Outcome|A: Daily ICS + Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
1167364|NCT00394329|E4|Reported Event|D: Placebo|"Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
1167365|NCT00394329|E3|Reported Event|C: Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
1167366|NCT00394329|E2|Reported Event|B: Daily ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
1167367|NCT00394329|E1|Reported Event|A: Daily ICS + Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
1167368|NCT00394277|B5|Baseline|Total|Total of all reporting groups
1167369|NCT00394277|B4|Baseline|PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
1167370|NCT00394277|B3|Baseline|PEG-IFN 360/180 µg + Ribavirin 1200 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
1167427|NCT00394212|B2|Baseline|Sham Endoscopy|Sham Endoscopy (suturing not performed)
1167428|NCT00394212|B1|Baseline|EndoCinch Suturing System:Transoral Suturing|Transoral suturing of the dilated gastrojejunostomy
1168018|NCT00392678|O3|Outcome|Salsalate 3.5 g/d|Salsalate 3.5 g/d, divided
1167371|NCT00394277|B2|Baseline|PEG-IFN 180 µg + Ribavirin 1400/1600 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
1167372|NCT00394277|B1|Baseline|PEG-IFN 180 µg + Ribavirin 1200 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
1167373|NCT00394277|P4|Participant Flow|PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
1167374|NCT00394277|P3|Participant Flow|PEG-IFN 360/180 µg + Ribavirin 1200 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
1167375|NCT00394277|P2|Participant Flow|PEG-IFN 180 µg + Ribavirin 1400/1600 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
1167376|NCT00394277|P1|Participant Flow|PEG-IFN 180 µg + Ribavirin 1200 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
1167377|NCT00394277|O4|Outcome|PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
1167378|NCT00394277|O3|Outcome|PEG-IFN 360/180 µg + Ribavirin 1200 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
1167379|NCT00394277|O2|Outcome|PEG-IFN 180 µg + Ribavirin 1400/1600 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
1167380|NCT00394277|O1|Outcome|PEG-IFN 180 µg + Ribavirin 1200 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
1167381|NCT00394277|O4|Outcome|PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
1167382|NCT00394277|O3|Outcome|PEG-IFN 360/180 µg + Ribavirin 1200 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
1167383|NCT00394277|O2|Outcome|PEG-IFN 180 µg + Ribavirin 1400/1600 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
1167384|NCT00394277|O1|Outcome|PEG-IFN 180 µg + Ribavirin 1200 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
1167385|NCT00394277|O4|Outcome|PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
1167386|NCT00394277|O3|Outcome|PEG-IFN 360/180 µg + Ribavirin 1200 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
1167387|NCT00394277|O2|Outcome|PEG-IFN 180 µg + Ribavirin 1400/1600 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
1167388|NCT00394277|O1|Outcome|PEG-IFN 180 µg + Ribavirin 1200 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
1167389|NCT00394277|O4|Outcome|PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
1167390|NCT00394277|O3|Outcome|PEG-IFN 360/180 µg + Ribavirin 1200 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
1167391|NCT00394277|O2|Outcome|PEG-IFN 180 µg + Ribavirin 1400/1600 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
1167393|NCT00394277|E4|Reported Event|PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
1167394|NCT00394277|E3|Reported Event|PEG-IFN 360/180 µg + Ribavirin 1200 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
1167395|NCT00394277|E2|Reported Event|PEG-IFN 180 µg + Ribavirin 1400/1600 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
1167396|NCT00394277|E1|Reported Event|PEG-IFN 180 µg + Ribavirin 1200 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
1167397|NCT00394251|B3|Baseline|Total|Total of all reporting groups
1167398|NCT00394251|B2|Baseline|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
1167399|NCT00394251|B1|Baseline|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
1167400|NCT00394251|P2|Participant Flow|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
1167401|NCT00394251|P1|Participant Flow|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
1167402|NCT00394251|O4|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m2 Taxol plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46).
1167403|NCT00394251|O3|Outcome|Taxol Subset|175 mg/m2 Taxol plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46). Weeks 1-8 are excluded from this subset.
1167404|NCT00394251|O2|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m2 ABI-007 (Abraxane) plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46).
1167405|NCT00394251|O1|Outcome|ABI-007 Subset|260 mg/m2 ABI-007 (Abraxane) plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46). Weeks 1-8 are excluded from this subset.
1167406|NCT00394251|O2|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
1167407|NCT00394251|O1|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
1167408|NCT00394251|O2|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
1167409|NCT00394251|O1|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
1167410|NCT00394251|O2|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
1167411|NCT00394251|O1|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
1167412|NCT00394251|O2|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
1167413|NCT00394251|O1|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
1167414|NCT00394251|O2|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
1167415|NCT00394251|O1|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
1167416|NCT00394251|O4|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m2 Taxol plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46).
1167417|NCT00394251|O3|Outcome|Taxol Subset|175 mg/m2 Taxol plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46). Weeks 1-8 are excluded from this subset.
1167418|NCT00394251|O2|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m2 ABI-007 (Abraxane) plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46).
1167419|NCT00394251|O1|Outcome|ABI-007 Subset|260 mg/m2 ABI-007 (Abraxane) plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46). Weeks 1-8 are excluded from this subset.
1167420|NCT00394251|O2|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
1167421|NCT00394251|O1|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
1167422|NCT00394251|O2|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
1167423|NCT00394251|O1|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
1167424|NCT00394251|E2|Reported Event|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
1167429|NCT00394212|P2|Participant Flow|Sham Endoscopy|Sham Endoscopy (suturing not performed)
1167430|NCT00394212|P1|Participant Flow|EndoCinch Suturing System:Transoral Suturing|Transoral suturing of the dilated gastrojejunostomy
1167431|NCT00394212|O2|Outcome|Sham Endoscopy|Sham Endoscopy (suturing not performed)
1167432|NCT00394212|O1|Outcome|EndoCinch Suturing System:Transoral Suturing|Transoral suturing of the dilated gastrojejunostomy
1167433|NCT00394212|O2|Outcome|Sham Endoscopy|Sham Endoscopy (suturing not performed)
1167434|NCT00394212|O1|Outcome|EndoCinch Suturing System:Transoral Suturing|Transoral suturing of the dilated gastrojejunostomy
1167435|NCT00394212|O2|Outcome|Sham Endoscopy|Sham Endoscopy (suturing not performed)
1167436|NCT00394212|O1|Outcome|EndoCinch Suturing System:Transoral Suturing|Transoral suturing of the dilated gastrojejunostomy
1167437|NCT00394212|O2|Outcome|Sham Endoscopy|Sham Endoscopy (suturing not performed)
1167438|NCT00394212|O1|Outcome|EndoCinch Suturing System:Transoral Suturing|Transoral suturing of the dilated gastrojejunostomy
1167439|NCT00394212|E2|Reported Event|Sham Endoscopy|Sham Endoscopy (suturing not performed)
1167440|NCT00394212|E1|Reported Event|EndoCinch Suturing System:Transoral Suturing|Transoral suturing of the dilated gastrojejunostomy
1167441|NCT00394095|B3|Baseline|Total|Total of all reporting groups
1167442|NCT00394095|B2|Baseline|Comparator Group: Placebo Group|Placebo Group Receiving oral placebo 300-400mg/day for 12 weeks
1167443|NCT00394095|B1|Baseline|Experimental Group: Topiramate Group|Experimental Group Receiving oral Topiramate, 300-400mg/day for 12 weeks
1167444|NCT00394095|P2|Participant Flow|Comparator Group: Placebo Group|Placebo Group Receiving oral placebo 300-400mg/day for 12 weeks
1167445|NCT00394095|P1|Participant Flow|Experimental Group: Topiramate Group|Experimental Group Receiving oral Topiramate, 300-400mg/day for 12 weeks
1167446|NCT00394095|O2|Outcome|Comparator Group: Placebo Group|Group receiving comparable dosage of placebo over 12 weeks.
1167447|NCT00394095|O1|Outcome|Experimental Group: Topiramate Group|Change in Body Weight in kilograms over 12 weeks in the Experimental Topiramate sample (N=16) compared to the Placebo group (N=14).
1167448|NCT00394095|O2|Outcome|Placebo Group|Group receiving comparable dosage of placebo over 12 weeks.
1167449|NCT00394095|O1|Outcome|Experimental Group: Topiramate Group|Change in Body Weight in kilograms over 12 weeks in the Experimental Topiramate sample (N=16) compared to the Placebo group (N=14).
1167450|NCT00394095|E2|Reported Event|Comparator Group: Placebo Group|Placebo Group Receiving oral placebo 300-400mg/day for 12 weeks
1167451|NCT00394095|E1|Reported Event|Experimental Group: Topiramate Group|Experimental Group Receiving oral Topiramate, 300-400mg/day for 12 weeks
1167452|NCT00394082|B1|Baseline|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
1167453|NCT00394082|P1|Participant Flow|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
1167454|NCT00394082|O1|Outcome|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
1167455|NCT00394082|O1|Outcome|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
1167456|NCT00394082|O1|Outcome|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
1167457|NCT00394082|O1|Outcome|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
1167458|NCT00394082|O1|Outcome|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
1167459|NCT00394082|O1|Outcome|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
1167495|NCT00393887|E2|Reported Event|Polypropylene Mesh|Synthetic polypropylene mesh
1167496|NCT00393887|E1|Reported Event|Biodesign IHM Graft|Biodesign Inguinal Hernia Matrix (IHM)
1167497|NCT00393874|B4|Baseline|Total|Total of all reporting groups
1167460|NCT00394082|E1|Reported Event|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
1167461|NCT00393939|B3|Baseline|Total|Total of all reporting groups
1167462|NCT00393939|B2|Baseline|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
1167463|NCT00393939|B1|Baseline|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
1167464|NCT00393939|P2|Participant Flow|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
1167465|NCT00393939|P1|Participant Flow|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
1167466|NCT00393939|O2|Outcome|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
1167467|NCT00393939|O1|Outcome|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
1167468|NCT00393939|O2|Outcome|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
1167469|NCT00393939|O1|Outcome|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
1167470|NCT00393939|O2|Outcome|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
1167471|NCT00393939|O1|Outcome|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
1167472|NCT00393939|O2|Outcome|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
1167473|NCT00393939|O1|Outcome|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
1167474|NCT00393939|O2|Outcome|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
1167475|NCT00393939|O1|Outcome|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
1167476|NCT00393939|O2|Outcome|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
1167477|NCT00393939|O1|Outcome|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
1167478|NCT00393939|O2|Outcome|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
1167479|NCT00393939|O1|Outcome|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
1167480|NCT00393939|E2|Reported Event|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
1167481|NCT00393939|E1|Reported Event|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
1167482|NCT00393913|B1|Baseline|Sleep Apnea Assessment|All participants were assigned to a single Arm (and received the intervention based on whether they had sleep apnea). Participants with sleep apnea used the CPAP machine for 4 to 6 weeks every night and then returned to the sleep laboratory for assessment of daytime function. Those without sleep apnea will have the initial assessment but then will not receive the intervention.
1167483|NCT00393913|P1|Participant Flow|CPAP|All participants with sleep apnea will use a CPAP machine for treatment of sleep apnea.
1167484|NCT00393913|O1|Outcome|Continuous Positive Pressure Treatment|All participants with sleep apnea will use a CPAP machine for treatment of sleep apnea.
1167485|NCT00393913|O1|Outcome|Continuous Positive Pressure Treatment|All participants with sleep apnea will use a CPAP machine for treatment of sleep apnea.
1167486|NCT00393913|O1|Outcome|Sleep Apnea|All participants with obstructive sleep apnea (and no other sleep disorder) and subjects without sleep apnea.
1167487|NCT00393913|E1|Reported Event|Continuous Positive Pressure Treatment|All participants with sleep apnea will use a CPAP machine for treatment of sleep apnea.
1167488|NCT00393887|B3|Baseline|Total|Total of all reporting groups
1167489|NCT00393887|B2|Baseline|Polypropylene Mesh|Synthetic polypropylene mesh
1167490|NCT00393887|B1|Baseline|Biodesign IHM Graft|Biodesign Inguinal Hernia Matrix (IHM)
1167491|NCT00393887|P2|Participant Flow|Polypropylene Mesh|Synthetic polypropylene mesh
1167492|NCT00393887|P1|Participant Flow|Biodesign IHM Graft|Biodesign Inguinal Hernia Matrix (IHM)
1167493|NCT00393887|O2|Outcome|Polypropylene Mesh|Inguinal hernia repair with Polypropylene mesh
1167494|NCT00393887|O1|Outcome|Biodesign IHM Graft|Inguinal hernia repair with Biodesign Inguinal Hernia Matrix (IHM)
1167498|NCT00393874|B3|Baseline|Placebo|"Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. They will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. We will monitor subjects carefully and on a weekly basis.~Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed."
1167499|NCT00393874|B2|Baseline|Behavioral|"Participants randomized to BSI will receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute booster session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).~Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction."
1167500|NCT00393874|B1|Baseline|Medication|"Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose.~Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). Prazosin will be administered in an initial oral dose of 1 mg (Week 1), with titration to a maximum of 15 mg. The first increment will be of 1 mg (Week 2: 2 mg), and subsequent weekly increments according to the following schedule: Week 3: 4 mg; Week 4: 6 mg; Week 5: 10 mg; Week 6: 15 mg; Week 7: 15 mg; Week 8: 15 mg. A maximum dose of 15 mg may be necessary."
1167501|NCT00393874|P3|Participant Flow|Placebo|"Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. They will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. We will monitor subjects carefully and on a weekly basis.~Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed."
1167502|NCT00393874|P2|Participant Flow|Behavioral|"Participants randomized to BSI will receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute booster session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).~Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction."
1167503|NCT00393874|P1|Participant Flow|Medication|"Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose.~Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). Prazosin will be administered in an initial oral dose of 1 mg (Week 1), with titration to a maximum of 15 mg. The first increment will be of 1 mg (Week 2: 2 mg), and subsequent weekly increments according to the following schedule: Week 3: 4 mg; Week 4: 6 mg; Week 5: 10 mg; Week 6: 15 mg; Week 7: 15 mg; Week 8: 15 mg. A maximum dose of 15 mg may be necessary."
1167504|NCT00393874|O3|Outcome|Placebo|"Participants randomized to PLA take 4 capsules each night, and capsule will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. A placebo pill condition is included for several reasons. First, there is no approved treatment approach currently recognized as being effective for sleep disturbances associated with combat-related PTSD, and which is being withheld from subjects assigned to the placebo arm of the study. We will monitor subjects carefully and on a weekly basis.~Placebo: Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medicat"
1167505|NCT00393874|O2|Outcome|Behavioral|"Participants randomized to BSI receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute booster session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).~Behavioral Sleep Intervention: Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction. Session 1 focuses on education on PDSD-related insomnia, ni"
1167582|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
1167506|NCT00393874|O1|Outcome|Medication|"Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Items include going to bed when drowsy, avoiding clock watching while awake in bed, avoidance of caffeine and alcohol, engaging in moderate exercise, and ensuring comfortable sleep environment. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose. The research pharmacy will prepare each dose in identical gelatin capsules to prevent identification.~Prazosin: Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). The target dose of prazosin is 10 mg. Some individuals may require doses up to 15 mg, (Murray Raskind, M.D., personal"
1167507|NCT00393874|O3|Outcome|Placebo|"Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. They will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. We will monitor subjects carefully and on a weekly basis.~Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed."
1167508|NCT00393874|O2|Outcome|Behavioral|"Participants randomized to BSI will receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute booster session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).~Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction."
1167509|NCT00393874|O1|Outcome|Medication|"Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose.~Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). Prazosin will be administered in an initial oral dose of 1 mg (Week 1), with titration to a maximum of 15 mg. The first increment will be of 1 mg (Week 2: 2 mg), and subsequent weekly increments according to the following schedule: Week 3: 4 mg; Week 4: 6 mg; Week 5: 10 mg; Week 6: 15 mg; Week 7: 15 mg; Week 8: 15 mg. A maximum dose of 15 mg may be necessary."
1167510|NCT00393874|O3|Outcome|Placebo|"Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. They will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. We will monitor subjects carefully and on a weekly basis.~Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed."
1167511|NCT00393874|O2|Outcome|Behavioral|"Participants randomized to BSI will receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute booster session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).~Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction."
1167512|NCT00393874|O1|Outcome|Medication|"Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose.~Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). Prazosin will be administered in an initial oral dose of 1 mg (Week 1), with titration to a maximum of 15 mg. The first increment will be of 1 mg (Week 2: 2 mg), and subsequent weekly increments according to the following schedule: Week 3: 4 mg; Week 4: 6 mg; Week 5: 10 mg; Week 6: 15 mg; Week 7: 15 mg; Week 8: 15 mg. A maximum dose of 15 mg may be necessary."
1167513|NCT00393874|O3|Outcome|Placebo|"Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. They will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. We will monitor subjects carefully and on a weekly basis.~Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed."
1167534|NCT00393848|P1|Participant Flow|Experiment 1 - Amino Acid Supplement|Essential amino acid supplement : 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
1167514|NCT00393874|O2|Outcome|Behavioral|"Participants randomized to BSI will receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute booster session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).~Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction."
1167515|NCT00393874|O1|Outcome|Medication|"Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose.~Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). Prazosin will be administered in an initial oral dose of 1 mg (Week 1), with titration to a maximum of 15 mg. The first increment will be of 1 mg (Week 2: 2 mg), and subsequent weekly increments according to the following schedule: Week 3: 4 mg; Week 4: 6 mg; Week 5: 10 mg; Week 6: 15 mg; Week 7: 15 mg; Week 8: 15 mg. A maximum dose of 15 mg may be necessary."
1167516|NCT00393874|E3|Reported Event|Placebo|"Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. A placebo pill condition is included for several reasons. First, there is no approved treatment approach currently recognized as being effective for sleep disturbances associated with combat-related PTSD, and which is being withheld from subjects assigned to the placebo arm of the study. We will monitor subjects carefully and on a weekly basis.~Placebo: Participants randomized to PLA took 4 capsules each night for eight weeks, all capsules were identical to prazosin capsules. They received a one-week medication."
1167517|NCT00393874|E2|Reported Event|Behavioral|"Participants randomized to BSI received the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment was administered over 8 weeks. The intervention sessions consisted of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute booster session was conducted on Week 5. Thirty-minute face-to-face contacts were scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that had occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).~Behavioral Sleep Intervention: Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction. Session 1 focuses on education on PDSD-related insomnia, ni"
1167518|NCT00393874|E1|Reported Event|Medication|"Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Items include going to bed when drowsy, avoiding clock watching while awake in bed, avoidance of caffeine and alcohol, engaging in moderate exercise, and ensuring comfortable sleep environment. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose. The research pharmacy will prepare each dose in identical gelatin capsules to prevent identification.~Prazosin: Participants randomized to PRZ took 4 capsules each night (PRZ dose complemented with placebo capsules ). The target dose of prazosin was 10 mg. Some individuals required doses up to 15 mg."
1167519|NCT00393861|B1|Baseline|Oxaliplatin & Bevacizumab|Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
1167520|NCT00393861|P1|Participant Flow|Oxaliplatin & Bevacizumab|Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
1167521|NCT00393861|O1|Outcome|Oxaliplatin & Bevacizumab|Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
1167522|NCT00393861|O1|Outcome|Oxaliplatin & Bevacizumab|Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
1167523|NCT00393861|O1|Outcome|Oxaliplatin & Bevacizumab|Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
1167524|NCT00393861|O1|Outcome|Oxaliplatin & Bevacizumab|Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
1167525|NCT00393861|E1|Reported Event|Oxaliplatin & Bevacizumab|Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
1167526|NCT00393848|B5|Baseline|Total|Total of all reporting groups
1167527|NCT00393848|B4|Baseline|Experiment 2 - Placebo|Placebo for Ketoconazole twice daily; started night before surgery and continued through hospitalization.
1167528|NCT00393848|B3|Baseline|Experiment 2 - Ketoconazole|200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.
1167529|NCT00393848|B2|Baseline|Experiment 1 - Standard of Care|Usual clinical care - no dietary intervention.
1167530|NCT00393848|B1|Baseline|Experiment 1 - Amino Acid Supplement|Essential amino acid supplement : 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
1167531|NCT00393848|P4|Participant Flow|Experiment 2 - Placebo|Placebo for Ketoconazole twice daily; started night before surgery and continued through hospitalization.
1167532|NCT00393848|P3|Participant Flow|Experiment 2 - Ketoconazole|200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.
1167533|NCT00393848|P2|Participant Flow|Experiment 1 - Standard of Care|Usual clinical care with no dietary intervention.
1167535|NCT00393848|O2|Outcome|Experiment 1 - Standard of Care|Usual clinical care with no dietary intervention.
1167583|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
1167536|NCT00393848|O1|Outcome|Experiment 1 - Amino Acid Supplement|Essential amino acid supplement : 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
1167537|NCT00393848|O4|Outcome|Experiment 2 - Placebo|Placebo for Ketoconazole twice daily; started night before surgery and continued through hospitalization.
1167538|NCT00393848|O3|Outcome|Experiment 2 - Ketoconazole|200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.
1167539|NCT00393848|O2|Outcome|Experiment 1 - Standard of Care|Usual clinical care without dietary intervention
1167540|NCT00393848|O1|Outcome|Experiment 1 - Amino Acid Supplement|Essential amino acid supplement : 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
1167541|NCT00393848|E4|Reported Event|Experiment 2 - Placebo|Placebo for Ketoconazole twice daily; started night before surgery and continued through hospitalization.
1167542|NCT00393848|E3|Reported Event|Experiment 2 - Ketoconazole|200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.
1167543|NCT00393848|E2|Reported Event|Experiment 1 - Standard of Care|Usual clinical care with no dietary intervention.
1167544|NCT00393848|E1|Reported Event|Experiment 1 - Amino Acid Supplement|Essential amino acid supplement: 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
1167545|NCT00393796|B3|Baseline|Total|Total of all reporting groups
1167546|NCT00393796|B2|Baseline|Placebo|Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
1167547|NCT00393796|B1|Baseline|SUTENT|Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
1167548|NCT00393796|P2|Participant Flow|Placebo|Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
1167549|NCT00393796|P1|Participant Flow|SUTENT|Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
1167550|NCT00393796|O2|Outcome|Placebo|Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
1167551|NCT00393796|O1|Outcome|SUTENT|Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
1167552|NCT00393796|E2|Reported Event|Placebo Only|"Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.~28 participants were randomized to Placebo. 16 of these 28 patients later received SUTENT."
1167553|NCT00393796|E1|Reported Event|SUTENT|"Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.~26 participants were randomized to SUTENT and 16 participants randomized to Placebo crossed over to SUTENT during treatment so a total of 42 participants were treated with SUTENT."
1167554|NCT00393718|B3|Baseline|Total|Total of all reporting groups
1167555|NCT00393718|B2|Baseline|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
1167556|NCT00393718|B1|Baseline|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
1167557|NCT00393718|P2|Participant Flow|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
1167558|NCT00393718|P1|Participant Flow|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
1167559|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
1167560|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
1167561|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
1167562|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
1167563|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
1167564|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
1167565|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
1167566|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
1167567|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
1167568|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
1167569|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
1167570|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
1167571|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
1167572|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
1167573|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
1167574|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
1167575|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
1167576|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
1167577|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
1167578|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
1167579|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
1167580|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
1167581|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
1168019|NCT00392678|O2|Outcome|Salsalate 3.0 g/d|Salsalate 3.0 g/d, divided
1167584|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
1167585|NCT00393718|E2|Reported Event|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
1167586|NCT00393718|E1|Reported Event|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
1167587|NCT00393705|B3|Baseline|Total|Total of all reporting groups
1167588|NCT00393705|B2|Baseline|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
1167589|NCT00393705|B1|Baseline|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
1167590|NCT00393705|P2|Participant Flow|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
1167591|NCT00393705|P1|Participant Flow|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
1167592|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
1167593|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
1167594|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
1167595|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
1167596|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
1167597|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
1167598|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
1167599|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
1167600|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
1167601|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
1167602|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
1167648|NCT00393510|O1|Outcome|Traditional Chinese Medicine|12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
1167649|NCT00393510|E2|Reported Event|Placebo|Placebo was made with starch and colouring materials. Given to patient orally twice a day
1167603|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
1167604|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
1167605|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
1167606|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
1167607|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
1167608|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
1167609|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
1167610|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
1167611|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
1167612|NCT00393705|E2|Reported Event|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
1167613|NCT00393705|E1|Reported Event|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
1167614|NCT00393523|B6|Baseline|Total|Total of all reporting groups
1167615|NCT00393523|B5|Baseline|Modified Process Hepatitis B Vaccine (Group 5)|Participants did not receive a prior vaccination with a hepatitis B vaccine; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms)
1167616|NCT00393523|B4|Baseline|ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
1167617|NCT00393523|B3|Baseline|Modified Process Hepatitis B Vaccine Booster (Group 3)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
1167618|NCT00393523|B2|Baseline|ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
1167619|NCT00393523|B1|Baseline|Modified Process Hepatitis B Vaccine Booster (Group 1)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
1167620|NCT00393523|P5|Participant Flow|Modified Process Hepatitis B Vaccine (Group 5)|Participants did not receive a prior vaccination with a hepatitis B vaccine; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms)
1167621|NCT00393523|P4|Participant Flow|ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
1167622|NCT00393523|P3|Participant Flow|Modified Process Hepatitis B Vaccine Booster (Group 3)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
1167623|NCT00393523|P2|Participant Flow|ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
1167624|NCT00393523|P1|Participant Flow|Modified Process Hepatitis B Vaccine Booster (Group 1)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
1167625|NCT00393523|O2|Outcome|ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
1167626|NCT00393523|O1|Outcome|Modified Process Hepatitis B Vaccine Booster (Group 3)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
1167627|NCT00393523|O2|Outcome|ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
1167628|NCT00393523|O1|Outcome|Modified Process Hepatitis B Vaccine Booster (Group 1)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
1167629|NCT00393523|O2|Outcome|ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
1167630|NCT00393523|O1|Outcome|Modified Process Hepatitis B Vaccine Booster (Group 3)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
1167631|NCT00393523|O2|Outcome|ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
1167632|NCT00393523|O1|Outcome|Modified Process Hepatitis B Vaccine Booster (Group 1)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
1167633|NCT00393523|E5|Reported Event|Modified Process Hepatitis B Vaccine (Group 5)|Participants did not receive a prior vaccination with a hepatitis B vaccine; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms)
1167634|NCT00393523|E4|Reported Event|ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
1167635|NCT00393523|E3|Reported Event|Modified Process Hepatitis B Vaccine Booster (Group 3)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
1167636|NCT00393523|E2|Reported Event|ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
1167637|NCT00393523|E1|Reported Event|Modified Process Hepatitis B Vaccine Booster (Group 1)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
1167638|NCT00393510|B3|Baseline|Total|Total of all reporting groups
1167639|NCT00393510|B2|Baseline|Placebo|Placebo was made with starch and colouring materials. Given to patient orally twice a day
1167640|NCT00393510|B1|Baseline|Traditional Chinese Medicine|12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
1167641|NCT00393510|P2|Participant Flow|Placebo|Placebo was made with starch and colouring materials. Given to patient orally twice a day
1167642|NCT00393510|P1|Participant Flow|Traditional Chinese Medicine|12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
1167643|NCT00393510|O2|Outcome|Placebo|Placebo was made with starch and colouring materials. Given to patient orally twice a day
1167644|NCT00393510|O1|Outcome|Traditional Chinese Medicine|12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
1167645|NCT00393510|O2|Outcome|Placebo|Placebo was made with starch and colouring materials. Given to patient orally twice a day
1167646|NCT00393510|O1|Outcome|Traditional Chinese Medicine|12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
1167647|NCT00393510|O2|Outcome|Placebo|Placebo was made with starch and colouring materials. Given to patient orally twice a day
1167749|NCT00393094|B1|Baseline|Enrollment Until Prior to Treatment|
1167650|NCT00393510|E1|Reported Event|Traditional Chinese Medicine|12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
1167651|NCT00393484|B3|Baseline|Total|Total of all reporting groups
1167652|NCT00393484|B2|Baseline|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
1167653|NCT00393484|B1|Baseline|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
1167654|NCT00393484|P2|Participant Flow|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
1167655|NCT00393484|P1|Participant Flow|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
1167656|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
1167657|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
1167658|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
1167659|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
1167660|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
1167661|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
1167662|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
1167663|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
1167664|NCT00393484|O2|Outcome|Lamivudine, 100 mg|Participants received lamivudine, 100 mg, once daily for up to 240 weeks
1167665|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
1167666|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
1167667|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
1167668|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
1167669|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
1167670|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
1167671|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
1167672|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
1167673|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
1167674|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
1167675|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
1167676|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
1167677|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
1167678|NCT00393484|O2|Outcome|Lamivudine, 100 mg+ Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
1167679|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
1167680|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
1167681|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
1167682|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
1167683|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
1167684|NCT00393484|E2|Reported Event|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
1167685|NCT00393484|E1|Reported Event|Entecavir , 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
1167686|NCT00393458|B5|Baseline|Total|Total of all reporting groups
1167687|NCT00393458|B4|Baseline|Placebo to Indacaterol Plus Placebo to Formoterol|Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1167688|NCT00393458|B3|Baseline|Formoterol 12 μg Plus Placebo to Indacaterol|Patients inhaled formoterol 12 μg twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1167689|NCT00393458|B2|Baseline|Indacaterol 600 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1167690|NCT00393458|B1|Baseline|Indacaterol 300 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1167691|NCT00393458|P4|Participant Flow|Placebo to Indacaterol Plus Placebo to Formoterol|Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1167692|NCT00393458|P3|Participant Flow|Formoterol 12 μg Plus Placebo to Indacaterol|Patients inhaled formoterol 12 μg twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1167693|NCT00393458|P2|Participant Flow|Indacaterol 600 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1167694|NCT00393458|P1|Participant Flow|Indacaterol 300 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1167695|NCT00393458|O4|Outcome|Placebo to Indacaterol Plus Placebo to Formoterol|Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1167696|NCT00393458|O3|Outcome|Formoterol 12 μg Plus Placebo to Indacaterol|Patients inhaled formoterol 12 μg twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1167697|NCT00393458|O2|Outcome|Indacaterol 600 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1167698|NCT00393458|O1|Outcome|Indacaterol 300 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1167699|NCT00393458|O4|Outcome|Placebo to Indacaterol Plus Placebo to Formoterol|Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1167700|NCT00393458|O3|Outcome|Formoterol 12 μg Plus Placebo to Indacaterol|Patients inhaled formoterol 12 μg twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1167701|NCT00393458|O2|Outcome|Indacaterol 600 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1167702|NCT00393458|O1|Outcome|Indacaterol 300 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1167750|NCT00393094|P1|Participant Flow|Enrollment Until Prior to Treatment|
1167703|NCT00393458|E4|Reported Event|Placebo to Indacaterol Plus Placebo to Formoterol|Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1167704|NCT00393458|E3|Reported Event|Formoterol 12 μg Plus Placebo to Indacaterol|Patients inhaled formoterol 12 μg twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1167705|NCT00393458|E2|Reported Event|Indacaterol 600 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1167706|NCT00393458|E1|Reported Event|Indacaterol 300 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1167707|NCT00393380|B1|Baseline|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
1167708|NCT00393380|P1|Participant Flow|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
1167709|NCT00393380|O1|Outcome|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
1167710|NCT00393380|O1|Outcome|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
1167711|NCT00393380|O1|Outcome|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
1167712|NCT00393380|O1|Outcome|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
1167713|NCT00393380|O1|Outcome|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
1167714|NCT00393380|O1|Outcome|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
1167715|NCT00393380|O1|Outcome|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
1167716|NCT00393380|O1|Outcome|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
1167717|NCT00393380|E1|Reported Event|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
1167718|NCT00393367|B3|Baseline|Total|Total of all reporting groups
1167719|NCT00393367|B2|Baseline|Placebo (Saline)|standardized treatment with nebulized saline
1167720|NCT00393367|B1|Baseline|Budesonide Inhalation Suspension (BIS)|standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)
1167721|NCT00393367|P2|Participant Flow|Placebo (Saline)|standardized treatment with nebulized saline
1167722|NCT00393367|P1|Participant Flow|Budesonide Inhalation Suspension (BIS)|standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)
1167723|NCT00393367|O2|Outcome|Placebo (Saline)|standardized treatment with nebulized saline
1167724|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)
1167725|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
1167726|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
1167727|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
1167728|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
1167729|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
1167730|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
1167731|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
1167732|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
1167733|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
1167734|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
1167735|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
1167736|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
1167737|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
1167738|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
1167739|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
1167740|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
1167741|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
1167742|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
1167743|NCT00393367|O2|Outcome|Placebo (Saline)|standardized treatment with nebulized saline
1167744|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)
1167745|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
1167746|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
1167747|NCT00393367|E2|Reported Event|Placebo (Saline)|standardized treatment with nebulized saline
1167748|NCT00393367|E1|Reported Event|Budesonide Inhalation Suspension (BIS)|standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)
1167751|NCT00393094|O1|Outcome|Bevacizumab & Irinotecan Glioblastoma Multiforme: Enrollment|Bevacizumab - 10 mg/kg intravenous injection Irinotecan - 125 mg/m^2 if patient is on a non-enzyme inducing anti-epileptic drugs 340 mg/m^2 if patient is on enzyme inducing anti-epileptic drugs every two weeks on a 4 week cycle Glioblastoma multiforme- is a fast growing type of central nervous system tumor that forms from glial (supportive) tissue of the brain and spinal cord and has cells that look very different from normal cells. Glioblastoma multiforme usually occurs in adults and affects the brain more often than the spinal cord. Also called GBM, glioblastoma, and grade IV astrocytoma.
1167752|NCT00393094|O1|Outcome|Bevacizumab & Irinotecan Anaplastic Glioma Pts: Enrollment|Bevacizumab - 10 mg/kg intravenous injection Irinotecan - 125 mg/m^2 if patient is on a non-enzyme inducing anti-epileptic drugs 340 mg/m^2 if patient is on enzyme inducing anti-epileptic drugs every two weeks on a 4 week cycle Anaplastic gliomas are classified by the World Health Organization (WHO) as grade 3 malignant tumors and include the anaplastic astrocytoma, anaplastic oligodendroglioma, and anaplastic oligoastrocytoma or mixed glioma.
1167753|NCT00393094|O1|Outcome|Enrollment Until Prior to Treatment|
1167754|NCT00393094|O1|Outcome|Enrollment Until Prior to Treatment|
1167755|NCT00393094|E1|Reported Event|Enrollment Until Prior to Treatment|
1167756|NCT00393068|B1|Baseline|Treatment|"Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks).~Surgery will be performed approximately 12-14 weeks after beginning this combined treatment."
1167757|NCT00393068|P1|Participant Flow|Treatment|"Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks).~Surgery will be performed approximately 12-14 weeks after beginning this combined treatment."
1167758|NCT00393068|O1|Outcome|Treatment|"Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks).~Surgery will be performed approximately 12-14 weeks after beginning this combined treatment."
1167759|NCT00393068|E1|Reported Event|Treatment|"Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks).~Surgery will be performed approximately 12-14 weeks after beginning this combined treatment."
1167760|NCT00393042|B1|Baseline|Overall Study|Participants either Adderall XR or Focalin XR for four weeks (3 dose levels and placebo) followed by four weeks (3 dose levels and placebo) of the opposite medication they received the first four weeks. Baseline Measures are based off all participants that were randomized regardless of the order they received the medication. Since we were interested in evaluating efficacy and adverse events at all dose conditions, participants were included in analysis if they received at least 2 weeks of study drug to insure that all participants had been exposed to at least one week of active drug
1167761|NCT00393042|P2|Participant Flow|Adderall XR Then Focalin XR|Adderall XR first for 4 weeks (3 dose levels and placebo) then Focalin XR for 4 weeks (3 dose levels and placebo).
1167762|NCT00393042|P1|Participant Flow|Focalin XR Then Adderall XR|Focalin XR first for 4 weeks (3 dose levels and placebo) then Adderall XR for 4 weeks (3 dose levels and placebo).
1167763|NCT00393042|O8|Outcome|Focalin XR - 25/30mg|This is the 25/30 mg dosage week for the Focalin XR medication.
1167764|NCT00393042|O7|Outcome|Focalin XR - 20 mg|This is the 20 mg dosage week for the Focalin XR medication.
1167765|NCT00393042|O6|Outcome|Focalin XR - 10 mg|This is the 10 mg dosage week for the Focalin XR medication.
1167766|NCT00393042|O5|Outcome|Focalin XR - Placebo|This is the Placebo dosage week for the Focalin XR medication.
1167767|NCT00393042|O4|Outcome|Adderall XR - 25/30mg|This is the 25/30 mg dosage week for the Adderall XR medication.
1167768|NCT00393042|O3|Outcome|Adderall XR - 20 mg|This is the 20 mg dosage week for the Adderall XR medication.
1167769|NCT00393042|O2|Outcome|Adderall XR - 10 mg|This is the 10 mg dosage week for the Adderall XR medication.
1167770|NCT00393042|O1|Outcome|Adderall XR - Placebo|This is the placebo dosage week for the Adderall XR medication.
1167771|NCT00393042|O8|Outcome|Focalin XR - 25/30 mg|This is the 25/30 mg dosage week for the Focalin XR medication.
1167772|NCT00393042|O7|Outcome|Focalin XR - 20 mg|This is the 20 mg dosage week for the Focalin XR medication.
1167773|NCT00393042|O6|Outcome|Focalin - 10 mg|This is the 10 mg dosage week for the Focalin XR medication.
1167774|NCT00393042|O5|Outcome|Focalin XR - Placebo|This is the placebo dosage week for the Focalin XR medication.
1167775|NCT00393042|O4|Outcome|Adderall XR - 25/30 mg|This is the 25/30 mg dosage week for the Adderall XR medication.
1167776|NCT00393042|O3|Outcome|Adderall XR - 20 mg|This is the 20 mg dosage week for the Adderall XR medication.
1167777|NCT00393042|O2|Outcome|Adderall XR - 10 mg|This is the 10 mg dosage week for the Adderall XR medication.
1167778|NCT00393042|O1|Outcome|Adderall XR - Placebo|This is the placebo dosage week for the Adderall XR medication.
1167779|NCT00393042|O24|Outcome|10/10 Allele: 25/30mg of Focaling XR|This is the 25/30 mg dosage of Focalin XR medication phase for the participants with the 10/10 allele
1167780|NCT00393042|O23|Outcome|10/10 Allele: 20 mg of Focalin XR|This is the 20 mg dosage of Focalin XR medication phase for the participants with the 10/10 allele
1167781|NCT00393042|O22|Outcome|10/10 Allele: 10 mg of Focalin XR|This is the 10 mg dosage of Focalin XR medication phase for the participants with the 10/10 allele
1167782|NCT00393042|O21|Outcome|10/10 Allele: Placebo of Focalin XR|This is the Placebo dosage of Focalin XR medication phase for the participants with the 10/10 allele
1167783|NCT00393042|O20|Outcome|10/10 Allele: 25/30 mg of Adderall XR|This is the 25/30 mg dosage of Adderall XR medication phase for the participants with the 10/10 allele
1167784|NCT00393042|O19|Outcome|10/10 Allele: 20 mg of Adderall XR|This is the 20 mg dosage of Adderall XR medication phase for the participants with the 10/10 allele
1167785|NCT00393042|O18|Outcome|10/10 Allele: 10 mg of Adderall XR|This is the 10 mg dosage of Adderall XR medication phase for the participants with the 10/10 allele
1167786|NCT00393042|O17|Outcome|10/10 Allele: Placebo of Adderall XR|This is the Placebo dosage of Adderall XR medication phase for the participants with the 10/10 allele
1167787|NCT00393042|O16|Outcome|9/10 Allele: 25/30 mg of Focalin XR|This is the 25/30 mg dosage of Focalin XR medication phase for the participants with the 9/10 allele
1167788|NCT00393042|O15|Outcome|9/10 Allele: 20 mg of Focalin XR|This is the 20 mg dosage of Focalin XR medication phase for the participants with the 9/10 allele
1167789|NCT00393042|O14|Outcome|9/10 Allele: 10 mg of Focalin XR|This is the 10 mg dosage of Focalin XR medication phase for the participants with the 9/10 allele
1167790|NCT00393042|O13|Outcome|9/10 Allele: Placebo of Focalin XR|This is the Placebo dosage of Focalin XR medication phase for the participants with the 9/10 allele
1167791|NCT00393042|O12|Outcome|9/10 Allele: 25/30 mg of Adderall XR|This is the 25/30 mg dosage of Adderall XR medication phase for the participants with the 9/10 allele
1167792|NCT00393042|O11|Outcome|9/10 Allele: 20 mg of Adderall XR|This is the 20 mg dosage of Adderall XR medication phase for the participants with the 9/10 allele
1167793|NCT00393042|O10|Outcome|9/10 Allele: 10 mg of Adderall XR|This is the 10 mg dosage of Adderall XR medication phase for the participants with the 9/10 allele
1167794|NCT00393042|O9|Outcome|9/10 Allele: Placebo of Adderall XR|This is the Placebo dosage of Adderall XR medication phase for the participants with the 9/10 allele
1167795|NCT00393042|O8|Outcome|9/9 Allele: 25/30 mg of Focalin XR|This is the 25/30 mg dosage of Focalin XR medication phase for the participants with the 9/9 allele
1167796|NCT00393042|O7|Outcome|9/9 Allele: 20 mg of Focalin XR|This is the 20 mg dosage of Focalin XR medication phase for the participants with the 9/9 allele
1167797|NCT00393042|O6|Outcome|9/9 Allele: 10 mg of Focalin XR|This is the 10 mg dosage of Focalin XR medication phase for the participants with the 9/9 allele
1167798|NCT00393042|O5|Outcome|9/9 Allele: Placebo of Focalin XR|This is the placebo dosage of Focalin XR medication phase for the participants with the 9/9 allele
1167799|NCT00393042|O4|Outcome|9/9 Allele: 25/30mg of Adderall XR|This is the 25/30 mg dosage of Adderall XR medication phase for the participants with the 9/9 allele
1167800|NCT00393042|O3|Outcome|9/9 Allele: 20 mg Adderall XR|This is the 20 mg dosage of Adderall XR medication phase for the participants with the 9/9 allele
1167801|NCT00393042|O2|Outcome|9/9 Allele: 10 mg of Adderall XR|This is the 10 mg dosage of Adderall XR medication phase for the participants with the 9/9 allele
1167802|NCT00393042|O1|Outcome|9/9 Allele: Placebo of Adderall XR|This is the Placebo dosage of Adderall XR medication phase for the participants with the 9/9 allele
1167803|NCT00393042|O8|Outcome|Focalin XR - 25/30mg|This is the 25/30 mg dosage week for the Focalin XR medication.
1167804|NCT00393042|O7|Outcome|Focalin XR - 20 mg|This is the 20 mg dosage week for the Focalin XR medication.
1167805|NCT00393042|O6|Outcome|Focalin XR - 10 mg|This is the 10 mg dosage week for the Focalin XR medication.
1167806|NCT00393042|O5|Outcome|Focalin XR - Placebo|This is the placebo dosage week for the Focalin XR medication.
1167807|NCT00393042|O4|Outcome|Adderall XR - 25/30mg|This is the 25/30 mg dosage week for the Adderall XR medication.
1167808|NCT00393042|O3|Outcome|Adderall XR - 20 mg|This is the 20 mg dosage week for the Adderall XR medication.
1167809|NCT00393042|O2|Outcome|Adderall XR - 10 mg|This is the 10 mg dosage week for the Adderall XR medication.
1167810|NCT00393042|O1|Outcome|Adderall XR - Placebo|This is the placebo dosage week for the Adderall XR medication.
1167811|NCT00393042|O6|Outcome|Focalin XR All Dose Levels|Participants were given 10mg, 20mg, 25/30mg (depending on their weight) and a randomized placebo week for 4 weeks. This data is combines the 10mg, 20mg, and 25/30mg data for Focalin XR.
1167812|NCT00393042|O5|Outcome|Adderall XR All Dose Levels|Participants were given 10mg, 20mg, 25/30mg (depending on their weight) and a randomized placebo week for 4 weeks. This data is combines the 10mg, 20mg, and 25/30mg data for Adderall XR.
1167813|NCT00393042|O4|Outcome|25/30mg of Either Focalin XR or Adderall XR|Each participant received 25/30mg of either Focalin XR or Adderall XR depending on their weight. The data collected from the 25/30mg week of both drugs was combined.
1167814|NCT00393042|O3|Outcome|20 mg of Either Focalin XR or Adderall XR|Each participant received 20mg of either Focalin XR or Adderall XR. The data collected from the 20mg week of both drugs was combined.
1167815|NCT00393042|O2|Outcome|10mg of Either Focalin XR or Adderall XR|Each participant received 10mg of either Focalin XR or Adderall XR. The data collected from the 10mg week of both drugs was combined.
1167816|NCT00393042|O1|Outcome|Placebo|Regardless of the medication the participants were taking, each 4 week period included a randomized placebo week. This data is based off each participant's placebo weeks.
1167817|NCT00393042|O6|Outcome|Focalin XR All Dose Levels|Participants were given 10mg, 20mg, 25/30mg (depending on their weight) and a randomized placebo week for 4 weeks. This data is combines the 10mg, 20mg, and 25/30mg data for Focalin XR.
1167818|NCT00393042|O5|Outcome|Adderall XR All Dose Levels|Participants were given 10mg, 20mg, 25/30mg (depending on their weight) and a randomized placebo week for 4 weeks. This data is combines the 10mg, 20mg, and 25/30mg data for Adderall XR.
1168020|NCT00392678|O1|Outcome|Placebo|Placebo
1168021|NCT00392678|O4|Outcome|Salsalate 4.0 g/d|Salsalate 4.0 g/d, divided
1167819|NCT00393042|O4|Outcome|25/30mg of Either Focalin XR or Adderall XR|Each participant received 25 or 30mg of either Focalin XR or Adderall XR depending on their weight. The data collected from the 25/30mg week of both drugs was combined.
1167820|NCT00393042|O3|Outcome|20mg of Either Focalin XR or Adderall XR|Each participant received 20mg of either Focalin XR or Adderall XR. The data collected from the 20mg week of both drugs was combined.
1167821|NCT00393042|O2|Outcome|10mg of Either Focalin XR or Adderall XR|Each participant received 10mg of either Focalin XR or Adderall XR. The data collected from the 10mg week of both drugs was combined.
1167822|NCT00393042|O1|Outcome|Placebo|Regardless of the medication the participants were taking, each 4 week period included a randomized placebo week. This data is based off each participant's placebo weeks.
1167823|NCT00393042|E8|Reported Event|25/30mg of Adderall XR|Each participant recieved 25/30 mg of Adderall XR once during the first four weeks or last four weeks depending on the randomization schedule.
1167824|NCT00393042|E7|Reported Event|20 mg of Adderall XR|Each participant recieved 20 mg of Adderall XR once during the first four weeks or last four weeks depending on the randomization schedule.
1167825|NCT00393042|E6|Reported Event|10mg of Adderall XR|Each participant recieved 10 mg of Adderall XR once during the first four weeks or last four weeks depending on the randomization schedule.
1167826|NCT00393042|E5|Reported Event|Placebo of Adderall XR|Each participant recieved placebo of Adderall XR once during the first four weeks or last four weeks depending on the randomization schedule.
1167827|NCT00393042|E4|Reported Event|25/30mg of Focalin XR|Each participant recieved 25/30 mg (depending on weight) of Focalin XR once during the first four weeks or last four weeks depending on the randomization schedule.
1167828|NCT00393042|E3|Reported Event|20 mg of Focalin XR|Each participant recieved 20 mg of Focalin XR once during the first four weeks or last four weeks depending on the randomization schedule.
1167829|NCT00393042|E2|Reported Event|10mg of Focalin XR|Each participant recieved 10 mg of Focalin XR once during the first four weeks or last four weeks depending on the randomization schedule.
1167830|NCT00393042|E1|Reported Event|Placebo of Focalin XR|Each participant recieved placebo of Focalin XR once during the first four weeks or last four weeks depending on the randomization schedule.
1167831|NCT00393029|B3|Baseline|Total|Total of all reporting groups
1167832|NCT00393029|B2|Baseline|Other Metastatic Cancers|
1167833|NCT00393029|B1|Baseline|Metastatic Melanoma|Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).
1167834|NCT00393029|P2|Participant Flow|Other Metastatic Cancers|
1167835|NCT00393029|P1|Participant Flow|Metastatic Melanoma|Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).
1167836|NCT00393029|O2|Outcome|Other Metastatic Cancers|
1167837|NCT00393029|O1|Outcome|Metastatic Melanoma|Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).
1167838|NCT00393029|O2|Outcome|Other Metastatic Cancers|
1167839|NCT00393029|O1|Outcome|Metastatic Melanoma|Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).
1167840|NCT00393029|O1|Outcome|Metastatic Melanoma & Other Metastatic Cancers|"Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).~There are no statistical differences between the arms, therefore, they can be combined for this outcome measure."
1167841|NCT00393029|E2|Reported Event|Other Metastatic Cancers|
1167842|NCT00393029|E1|Reported Event|Metastatic Melanoma|Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).
1167843|NCT00392925|B5|Baseline|Total|Total of all reporting groups
1167844|NCT00392925|B4|Baseline|Non-Randomized From 4 Week Lead-In|During the 4-week lead-in period, all participants self administered subcutaneous (SC) injections of pramlintide acetate 180 mcg twice per week (BID) for 2 weeks followed by pramlintide acetate 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups (metreleptin, pramlintide, or pramlintide+metreleptin). 38 participants were not randomized into one of the 3 treatment groups and withdrew from the study.
1167845|NCT00392925|B3|Baseline|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167846|NCT00392925|B2|Baseline|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167847|NCT00392925|B1|Baseline|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167848|NCT00392925|P4|Participant Flow|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167849|NCT00392925|P3|Participant Flow|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167850|NCT00392925|P2|Participant Flow|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 milligram (mg) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167893|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1168022|NCT00392678|O3|Outcome|Salsalate 3.5 g/d|Salsalate 3.5 g/d, divided
1168023|NCT00392678|O2|Outcome|Salsalate 3.0 g/d|Salsalate 3.0 g/d, divided
1167851|NCT00392925|P1|Participant Flow|Non-Randomized From 4 Week Lead-In|During the 4-week lead-in period, all participants self administered a subcutaneous injection of pramlintide acetate 180 mcg twice per week (BID) for 2 weeks followed by pramlintide 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups (metreleptin, pramlintide, or pramlintide+metreleptin). 38 participants were not Randomized into one of the 3 treatment groups and withdrew from the study.
1167852|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167853|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167854|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167855|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167856|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167857|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167858|NCT00392925|O4|Outcome|Non-Randomized From 4 Week Lead-In|During the 4-week lead-in period, all participants self administered subcutaneous (SC) injections of pramlintide acetate180 mcg twice per week (BID) for 2 weeks followed by pramlintide acetate 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups (metreleptin, pramlintide, or pramlintide+metreleptin). 38 participants were not randomized into one of the 3 treatment groups and withdrew from the study.
1167859|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167860|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167861|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167862|NCT00392925|O4|Outcome|Non-Randomized From 4 Week Lead-In|During the 4-week lead-in period, all participants self administered subcutaneous (SC) injections of pramlintide acetate 180 mcg twice per week (BID) for 2 weeks followed by pramlintide acetate 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups (metreleptin, pramlintide, or pramlintide+metreleptin). 38 participants were not randomized into one of the 3 treatment groups and withdrew from the study.
1167863|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167864|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167865|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167866|NCT00392925|O4|Outcome|Non-Randomized From 4 Week Lead-In|During the 4-week lead-in period, all participants self administered subcutaneous (SC) injections of pramlintide acetate180 mcg twice per week (BID) for 2 weeks followed by pramlintide acetate 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups (metreleptin, pramlintide, or pramlintide+metreleptin). 38 participants were not randomized into one of the 3 treatment groups and withdrew from the study.
1167867|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167868|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167869|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167870|NCT00392925|O4|Outcome|Non-Randomized From 4 Week Lead-In|During the 4-week lead-in period, all participants self administered subcutaneous (SC) injections of pramlintide acetate 180 mcg twice per week (BID) for 2 weeks followed by pramlintide acetate 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups (metreleptin, pramlintide, or pramlintide+metreleptin). 38 participants were not randomized into one of the 3 treatment groups and withdrew from the study.
1167871|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167872|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167873|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167874|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167875|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167876|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167877|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167878|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167879|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167880|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167881|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167882|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167883|NCT00392925|O3|Outcome|Pramlintide + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167884|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167885|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167886|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167887|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167888|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167889|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167890|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167891|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167892|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167894|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167895|NCT00392925|O3|Outcome|Pramlintide Acetate+ Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167896|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167897|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167898|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167899|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167900|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167901|NCT00392925|O3|Outcome|Pramlintide Acetate+ Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167902|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167903|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167904|NCT00392925|O3|Outcome|Pramlintide + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167905|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167906|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167907|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167908|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167909|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167910|NCT00392925|O1|Outcome|Lead-In Participants Randomized to Treatment on Day 1|During the 4-week lead-in period, all participants self administered subcutaneous (SC) injections of pramlintide 180 mcg twice per week (BID) for 2 weeks followed by pramlintide 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to a treatment group.
1167911|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167912|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167913|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167914|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167915|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167916|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1168024|NCT00392678|O1|Outcome|Placebo|Placebo
1168025|NCT00392678|O4|Outcome|Salsalate 4.0 g/d|Salsalate 4.0 g/d, divided
1167917|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167918|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167919|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167920|NCT00392925|O3|Outcome|Pramlintide + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167921|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167922|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167923|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167924|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167925|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167926|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167927|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167928|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167929|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide Acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167930|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide Acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167931|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167932|NCT00392925|E4|Reported Event|Participants Not Randomized to Group After Lead-In Period|During the 4-week lead-in period, all participants self administered a subcutaneous injection of pramlintide 180 mcg twice per week (BID) for 2 weeks followed by pramlintide 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups (metreleptin, pramlintide, or pramlintide+metreleptin). 38 participants were not Randomized into one of the 3 treatment groups and withdrew from the study.
1167933|NCT00392925|E3|Reported Event|Pramlintide + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167934|NCT00392925|E2|Reported Event|Pramlintide + Placebo|Participants self administered subcutaneous (SC) injections of Pramlintide 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167935|NCT00392925|E1|Reported Event|Placebo + Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
1167936|NCT00392860|B3|Baseline|Total|Total of all reporting groups
1167937|NCT00392860|B2|Baseline|Control Group|Participants will be given a new standard handrim.
1167938|NCT00392860|B1|Baseline|Natural-Fit Experiment|"Participants will have a Natural-Fit installed on their wheelchair.~Natural-Fit : Ergonomic handrim for wheelchairs"
1167939|NCT00392860|P3|Participant Flow|Handrim Control Group|Participants will be given a new standard handrim.
1167940|NCT00392860|P2|Participant Flow|PalmRim Experiment|"Participants will have a PalmRim handrim installed on their wheelchair. The PalmRim was designed for individuals who have limited hand function, making it difficult to grasp standard handrims.~Participants were to use the PalmRim handrim for a four month trial period, before returning for follow up evaluations."
1168026|NCT00392678|O3|Outcome|Salsalate 3.5 g/d|Salsalate 3.5 g/d, divided
1168027|NCT00392678|O2|Outcome|Salsalate 3.0 g/d|Salsalate 3.0 g/d, divided
1168028|NCT00392678|O1|Outcome|Placebo|Placebo
1168029|NCT00392678|O4|Outcome|Salsalate 4.0 g/d|Salsalate 4.0 g/d, divided
1167941|NCT00392860|P1|Participant Flow|Natural-Fit Experiment|"Participants will have a Natural-Fit handrim installed on their wheelchair. The Natural-Fit device was designed to directly address the shortcomings of standard handrims and to improve the standard round-tube handrims which were designed over 50 years ago.~Participants used the Natural-Fit Handrim for a four month trial period, before returning for follow up evaluations.~Natural-Fit : Ergonomic handrim for wheelchairs"
1167942|NCT00392860|O2|Outcome|Handrim Control Group|Participants will be given a new standard handrim.
1167943|NCT00392860|O1|Outcome|Natural-Fit Experiment|"Participants will have a Natural-Fit handrim installed on their wheelchair.~Natural-Fit : Ergonomic handrim for wheelchairs"
1167944|NCT00392860|E2|Reported Event|Control Group|Participants will be given a new standard handrim.
1167945|NCT00392860|E1|Reported Event|Natural-Fit Experiment|"Participants will have a Natural-Fit installed on their wheelchair.~Natural-Fit : Ergonomic handrim for wheelchairs"
1167946|NCT00392834|B3|Baseline|Total|Total of all reporting groups
1167947|NCT00392834|B2|Baseline|Regimen B (Rituximab and IVAC Chemotherapy)|Patients receive rituximab IV on day 1, ifosfamide IV continuously and etoposide IV continuously over 24 hours on days 1-5, and high-dose cytarabine IV over 1-3 hours twice daily on days 1-2. Patients receive CNS prophylaxis comprising methotrexate IT and hydrocortisone IT on day 5. Patients also receive pegfilgrastim SC once 24-48 hours after completion of chemotherapy OR G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients with CNS involvement (leptomeningeal and/or intraparenchymal) at diagnosis do not receive CNS prophylaxis as above. Instead, these patients receive a combination of sequential liposomal cytarabine and methotrexate IT or via an Ommaya reservoir on day 1 and then every 14 days as tolerated until completion of systemic chemotherapy.
1167948|NCT00392834|B1|Baseline|Regimen A (R-CODOX-M Chemotherapy)|Patients receive rituximab IV and doxorubicin hydrochloride IV over 15 minutes on day 1, cyclophosphamide IV over 30-60 minutes on days 1 and 2, pegfilgrastim SC on day 3, vincristine IV on days 1 and 8, high-dose methotrexate IV over 2-4 hours on day 15, and leucovorin calcium IV beginning 24 hours after the start of methotrexate and continuing every 6 hours until level is adequate. Patients receive CNS prophylaxis of methotrexate IT, cytarabine IT, and hydrocortisone IT on day 1. Patients with high-risk disease receive an additional dose of cytarabine IT on day 3. Patients also receive G-CSF SC once daily on days 3-9. Once the methotrexate levels drops below 50 nmol/L, patients resume G-CSF SC once daily beginning on approximately day 18 and continuing until blood counts recover.
1167949|NCT00392834|P2|Participant Flow|Regimen B (Rituximab and IVAC Chemotherapy)|Patients receive rituximab IV on day 1, ifosfamide IV continuously and etoposide IV continuously over 24 hours on days 1-5, and high-dose cytarabine IV over 1-3 hours twice daily on days 1-2. Patients receive CNS prophylaxis comprising methotrexate IT and hydrocortisone IT on day 5. Patients also receive pegfilgrastim SC once 24-48 hours after completion of chemotherapy OR G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients with CNS involvement (leptomeningeal and/or intraparenchymal) at diagnosis do not receive CNS prophylaxis as above. Instead, these patients receive a combination of sequential liposomal cytarabine and methotrexate IT or via an Ommaya reservoir on day 1 and then every 14 days as tolerated until completion of systemic chemotherapy.
1167950|NCT00392834|P1|Participant Flow|Regimen A (R-CODOX-M Chemotherapy)|Patients receive rituximab IV and doxorubicin hydrochloride IV over 15 minutes on day 1, cyclophosphamide IV over 30-60 minutes on days 1 and 2, pegfilgrastim SC on day 3, vincristine IV on days 1 and 8, high-dose methotrexate IV over 2-4 hours on day 15, and leucovorin calcium IV beginning 24 hours after the start of methotrexate and continuing every 6 hours until level is adequate. Patients receive CNS prophylaxis of methotrexate IT, cytarabine IT, and hydrocortisone IT on day 1. Patients with high-risk disease receive an additional dose of cytarabine IT on day 3. Patients also receive G-CSF SC once daily on days 3-9. Once the methotrexate levels drops below 50 nmol/L, patients resume G-CSF SC once daily beginning on approximately day 18 and continuing until blood counts recover.
1167951|NCT00392834|O2|Outcome|Regimen B (Rituximab and IVAC Chemotherapy)|Patients receive rituximab IV on day 1, ifosfamide IV continuously and etoposide IV continuously over 24 hours on days 1-5, and high-dose cytarabine IV over 1-3 hours twice daily on days 1-2. Patients receive CNS prophylaxis comprising methotrexate IT and hydrocortisone IT on day 5. Patients also receive pegfilgrastim SC once 24-48 hours after completion of chemotherapy OR G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients with CNS involvement (leptomeningeal and/or intraparenchymal) at diagnosis do not receive CNS prophylaxis as above. Instead, these patients receive a combination of sequential liposomal cytarabine and methotrexate IT or via an Ommaya reservoir on day 1 and then every 14 days as tolerated until completion of systemic chemotherapy.
1167952|NCT00392834|O1|Outcome|Regimen A (R-CODOX-M Chemotherapy)|Patients receive rituximab IV and doxorubicin hydrochloride IV over 15 minutes on day 1, cyclophosphamide IV over 30-60 minutes on days 1 and 2, pegfilgrastim SC on day 3, vincristine IV on days 1 and 8, high-dose methotrexate IV over 2-4 hours on day 15, and leucovorin calcium IV beginning 24 hours after the start of methotrexate and continuing every 6 hours until level is adequate. Patients receive CNS prophylaxis of methotrexate IT, cytarabine IT, and hydrocortisone IT on day 1. Patients with high-risk disease receive an additional dose of cytarabine IT on day 3. Patients also receive G-CSF SC once daily on days 3-9. Once the methotrexate levels drops below 50 nmol/L, patients resume G-CSF SC once daily beginning on approximately day 18 and continuing until blood counts recover.
1167953|NCT00392834|E2|Reported Event|Regimen B (Rituximab and IVAC Chemotherapy)|Patients receive rituximab IV on day 1, ifosfamide IV continuously and etoposide IV continuously over 24 hours on days 1-5, and high-dose cytarabine IV over 1-3 hours twice daily on days 1-2. Patients receive CNS prophylaxis comprising methotrexate IT and hydrocortisone IT on day 5. Patients also receive pegfilgrastim SC once 24-48 hours after completion of chemotherapy OR G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients with CNS involvement (leptomeningeal and/or intraparenchymal) at diagnosis do not receive CNS prophylaxis as above. Instead, these patients receive a combination of sequential liposomal cytarabine and methotrexate IT or via an Ommaya reservoir on day 1 and then every 14 days as tolerated until completion of systemic chemotherapy.
1167986|NCT00392782|O1|Outcome|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
1167954|NCT00392834|E1|Reported Event|Regimen A (R-CODOX-M Chemotherapy)|Patients receive rituximab IV and doxorubicin hydrochloride IV over 15 minutes on day 1, cyclophosphamide IV over 30-60 minutes on days 1 and 2, pegfilgrastim SC on day 3, vincristine IV on days 1 and 8, high-dose methotrexate IV over 2-4 hours on day 15, and leucovorin calcium IV beginning 24 hours after the start of methotrexate and continuing every 6 hours until level is adequate. Patients receive CNS prophylaxis of methotrexate IT, cytarabine IT, and hydrocortisone IT on day 1. Patients with high-risk disease receive an additional dose of cytarabine IT on day 3. Patients also receive G-CSF SC once daily on days 3-9. Once the methotrexate levels drops below 50 nmol/L, patients resume G-CSF SC once daily beginning on approximately day 18 and continuing until blood counts recover.
1167955|NCT00392821|B1|Baseline|RAD001 and Sorafenib|"RAD001 and Sorafenib~Sorafenib: Sorafenib~RAD001: RAD001"
1167956|NCT00392821|P1|Participant Flow|RAD001 and Sorafenib|"RAD001 and Sorafenib~Sorafenib: Sorafenib~RAD001: RAD001"
1167957|NCT00392821|O1|Outcome|RAD001 and Sorafenib|"RAD001 and Sorafenib~Sorafenib: Sorafenib~RAD001: RAD001"
1167958|NCT00392821|O1|Outcome|RAD001 and Sorafenib|"RAD001 and Sorafenib~Sorafenib: Sorafenib~RAD001: RAD001"
1167959|NCT00392821|E1|Reported Event|RAD001 and Sorafenib|"RAD001 and Sorafenib~Sorafenib: Sorafenib~RAD001: RAD001"
1167960|NCT00392808|B5|Baseline|Total|Total of all reporting groups
1167961|NCT00392808|B4|Baseline|MENC-TT/MENC-TT|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine
1167962|NCT00392808|B3|Baseline|MENC-TT/MENC-CRM|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine
1167963|NCT00392808|B2|Baseline|MENC-CRM/MENC-TT|Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT
1167964|NCT00392808|B1|Baseline|MENC-CRM/MENC-CRM|Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine
1167965|NCT00392808|P4|Participant Flow|MENC-CRM/MENC-CRM|Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine
1167966|NCT00392808|P3|Participant Flow|MENC-CRM/MENC-TT|Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT
1167967|NCT00392808|P2|Participant Flow|MENC-TT/MENC-CRM|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine
1167968|NCT00392808|P1|Participant Flow|MENC-TT/MENC-TT|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine
1167969|NCT00392808|O4|Outcome|MENC-CRM/MENC-CRM|Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine
1167970|NCT00392808|O3|Outcome|MENC-CRM/MENC-TT|Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT
1167971|NCT00392808|O2|Outcome|MENC-TT/MENC-CRM|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine
1167972|NCT00392808|O1|Outcome|MENC-TT/MENC-TT|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine
1167973|NCT00392808|O4|Outcome|MENC-CRM/MENC-CRM|Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine
1167974|NCT00392808|O3|Outcome|MENC-CRM/MENC-TT|Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT
1167975|NCT00392808|O2|Outcome|MENC-TT/MENC-CRM|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine
1167976|NCT00392808|O1|Outcome|MENC-TT/MENC-TT|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine
1167977|NCT00392808|E4|Reported Event|MENC-CRM/MENC-CRM|Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine
1167978|NCT00392808|E3|Reported Event|MENC-CRM/MENC-TT|Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT
1167979|NCT00392808|E2|Reported Event|MENC-TT/MENC-CRM|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine
1167980|NCT00392808|E1|Reported Event|MENC-TT/MENC-TT|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine
1167981|NCT00392782|B1|Baseline|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
1167982|NCT00392782|P1|Participant Flow|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
1167983|NCT00392782|O1|Outcome|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
1167984|NCT00392782|O1|Outcome|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
1167985|NCT00392782|O1|Outcome|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
1168012|NCT00392678|O1|Outcome|Placebo|Placebo
1168013|NCT00392678|O4|Outcome|Placebo|Placebo
1168014|NCT00392678|O3|Outcome|Salsalate 4.0 g/d|Salsalate 4.0 g/d, divided
1168015|NCT00392678|O2|Outcome|Salsalate 3.5 g/d|Salsalate 3.5 g/d, divided
1168016|NCT00392678|O1|Outcome|Salsalate 3.0 g/d|Salsalate 3.0 g/d, divided
1167987|NCT00392782|O1|Outcome|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
1167988|NCT00392782|O1|Outcome|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
1167989|NCT00392782|O1|Outcome|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
1167990|NCT00392782|E1|Reported Event|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
1167991|NCT00392769|B1|Baseline|Cetuximab|400 mg/m^2 intravenous (IV) over 120 Minutes, followed by weekly infusions at 250 mg/m^2 IV over 60 minutes.
1167992|NCT00392769|P1|Participant Flow|Cetuximab|400 mg/m^2 intravenous (IV) over 120 Minutes, followed by weekly infusions at 250 mg/m^2 IV over 60 minutes.
1167993|NCT00392769|O1|Outcome|Cetuximab|400 mg/m^2 intravenous (IV) over 120 Minutes, followed by weekly infusions at 250 mg/m^2 IV over 60 minutes.
1167994|NCT00392769|E1|Reported Event|Cetuximab|400 mg/m^2 intravenous (IV) over 120 Minutes, followed by weekly infusions at 250 mg/m^2 IV over 60 minutes.
1167995|NCT00392704|B1|Baseline|Intervention|"All patients initially received treatment with paclitaxel 200 mg/m2, 3 hour IV infusion days 1 and 22; carboplatin area under the curve (AUC) 6.0 IV, days 1 and 22; 5-fluorouracil (5-FU) 200 mg/m2 daily by 24-hour continuous IV infusion, days 1 to 43; bevacizumab 15 mg/kg IV infusion days 1 and 22.~One to three weeks after completing neoadjuvant therapy, patients began treatment with concurrent chemoradiation, bevacizumab, and erlotinib. Radiation therapy began on day 1, with 1.8-Gy single daily doses, Monday through Friday, to a total dose of 68.4 Gy. Paclitaxel 50 mg/m2 was administered by 1-hour IV infusion on days 1 and 22. Erlotinib 150 mg by mouth daily began concurrently with radiation therapy and continued daily during the 7-week course of radiation."
1167996|NCT00392704|P1|Participant Flow|Intervention|"All patients initially received treatment with paclitaxel 200 mg/m2, 3 hour IV infusion days 1 and 22; carboplatin area under the curve (AUC) 6.0 IV, days 1 and 22; 5-fluorouracil (5-FU) 200 mg/m2 daily by 24-hour continuous IV infusion, days 1 to 43; bevacizumab 15 mg/kg IV infusion days 1 and 22.~One to three weeks after completing neoadjuvant therapy, patients began treatment with concurrent chemoradiation, bevacizumab, and erlotinib. Radiation therapy began on day 1, with 1.8-Gy single daily doses, Monday through Friday, to a total dose of 68.4 Gy. Paclitaxel 50 mg/m2 was administered by 1-hour IV infusion on days 1 and 22. Erlotinib 150 mg by mouth daily began concurrently with radiation therapy and continued daily during the 7-week course of radiation."
1167997|NCT00392704|O1|Outcome|Intervention|"All patients initially received treatment with paclitaxel 200 mg/m2, 3 hour IV infusion days 1 and 22; carboplatin area under the curve (AUC) 6.0 IV, days 1 and 22; 5-fluorouracil (5-FU) 200 mg/m2 daily by 24-hour continuous IV infusion, days 1 to 43; bevacizumab 15 mg/kg IV infusion days 1 and 22.~One to three weeks after completing neoadjuvant therapy, patients began treatment with concurrent chemoradiation, bevacizumab, and erlotinib. Radiation therapy began on day 1, with 1.8-Gy single daily doses, Monday through Friday, to a total dose of 68.4 Gy. Paclitaxel 50 mg/m2 was administered by 1-hour IV infusion on days 1 and 22. Erlotinib 150 mg by mouth daily began concurrently with radiation therapy and continued daily during the 7-week course of radiation."
1167998|NCT00392704|O1|Outcome|Intervention|"All patients initially received treatment with paclitaxel 200 mg/m2, 3 hour IV infusion days 1 and 22; carboplatin area under the curve (AUC) 6.0 IV, days 1 and 22; 5-fluorouracil (5-FU) 200 mg/m2 daily by 24-hour continuous IV infusion, days 1 to 43; bevacizumab 15 mg/kg IV infusion days 1 and 22.~One to three weeks after completing neoadjuvant therapy, patients began treatment with concurrent chemoradiation, bevacizumab, and erlotinib. Radiation therapy began on day 1, with 1.8-Gy single daily doses, Monday through Friday, to a total dose of 68.4 Gy. Paclitaxel 50 mg/m2 was administered by 1-hour IV infusion on days 1 and 22. Erlotinib 150 mg by mouth daily began concurrently with radiation therapy and continued daily during the 7-week course of radiation."
1167999|NCT00392704|E1|Reported Event|Intervention|"All patients initially received treatment with paclitaxel 200 mg/m2, 3 hour IV infusion days 1 and 22; carboplatin area under the curve (AUC) 6.0 IV, days 1 and 22; 5-fluorouracil (5-FU) 200 mg/m2 daily by 24-hour continuous IV infusion, days 1 to 43; bevacizumab 15 mg/kg IV infusion days 1 and 22.~One to three weeks after completing neoadjuvant therapy, patients began treatment with concurrent chemoradiation, bevacizumab, and erlotinib. Radiation therapy began on day 1, with 1.8-Gy single daily doses, Monday through Friday, to a total dose of 68.4 Gy. Paclitaxel 50 mg/m2 was administered by 1-hour IV infusion on days 1 and 22. Erlotinib 150 mg by mouth daily began concurrently with radiation therapy and continued daily during the 7-week course of radiation."
1168000|NCT00392678|B5|Baseline|Total|Total of all reporting groups
1168001|NCT00392678|B4|Baseline|Placebo|
1168002|NCT00392678|B3|Baseline|Salsalate 4.0 g/d|
1168003|NCT00392678|B2|Baseline|Salsalate 3.5 g/d|
1168004|NCT00392678|B1|Baseline|Salsalate 3.0 g/d|
1168005|NCT00392678|P4|Participant Flow|Placebo|
1168006|NCT00392678|P3|Participant Flow|Salsalate 4.0 g/d|
1168007|NCT00392678|P2|Participant Flow|Salsalate 3.5 g/d|
1168008|NCT00392678|P1|Participant Flow|Salsalate 3.0 g/d|
1168009|NCT00392678|O4|Outcome|Salsalate 4.0 g/d|Salsalate 4.0 g/d, divided
1168010|NCT00392678|O3|Outcome|Salsalate 3.5 g/d|Salsalate 3.5 g/d, divided
1168011|NCT00392678|O2|Outcome|Salsalate 3.0 g/d|Salsalate 3.0 g/d, divided
1168031|NCT00392678|O2|Outcome|Salsalate 3.0 g/d|Salsalate 3.0 g/d, divided
1168032|NCT00392678|O1|Outcome|Placebo|Placebo
1168033|NCT00392678|O4|Outcome|Placebo|Placebo
1168034|NCT00392678|O3|Outcome|Salsalate 4.0 g/d|Salsalate 4.0 g/d, divided
1168035|NCT00392678|O2|Outcome|Salsalate 3.5 g/d|Salsalate 3.5 g/d, divided
1168036|NCT00392678|O1|Outcome|Salsalate 3.0 g/d|Salsalate 3.0 g/d, divided
1168037|NCT00392678|E4|Reported Event|Placebo|
1168038|NCT00392678|E3|Reported Event|Salsalate 4.0 g/d|
1168039|NCT00392678|E2|Reported Event|Salsalate 3.5 g/d|
1168040|NCT00392678|E1|Reported Event|Salsalate 3.0 g/d|
1168041|NCT00392665|B3|Baseline|Total|Total of all reporting groups
1168042|NCT00392665|B2|Baseline|Erlotinib + Sulindac|"erlotinib plus sulindac~erlotinib: Given orally once a day~Sulindac: Given orally twice a day"
1168043|NCT00392665|B1|Baseline|Erlotinib + Bevacizumab|"erlotinib plus bevacizumab~Bevacizumab: Given intravenously on day one of each 3 week cycle~erlotinib: Given orally once a day"
1168044|NCT00392665|P2|Participant Flow|Erlotinib + Sulindac|"erlotinib plus sulindac~erlotinib: Given orally once a day~Sulindac: Given orally twice a day"
1168045|NCT00392665|P1|Participant Flow|Erlotinib + Bevacizumab|"erlotinib plus bevacizumab~Bevacizumab: Given intravenously on day one of each 3 week cycle~erlotinib: Given orally once a day"
1168046|NCT00392665|O2|Outcome|Erlotinib + Sulindac|"erlotinib plus sulindac~erlotinib: Given orally once a day~Sulindac: Given orally twice a day"
1168047|NCT00392665|O1|Outcome|Erlotinib + Bevacizumab|"erlotinib plus bevacizumab~Bevacizumab: Given intravenously on day one of each 3 week cycle~erlotinib: Given orally once a day"
1168048|NCT00392665|O2|Outcome|Erlotinib + Sulindac|"erlotinib plus sulindac~erlotinib: Given orally once a day~Sulindac: Given orally twice a day"
1168049|NCT00392665|O1|Outcome|Erlotinib + Bevacizumab|"erlotinib plus bevacizumab~Bevacizumab: Given intravenously on day one of each 3 week cycle~erlotinib: Given orally once a day"
1168050|NCT00392665|O2|Outcome|Erlotinib + Sulindac|"erlotinib plus sulindac~erlotinib: Given orally once a day~Sulindac: Given orally twice a day"
1168051|NCT00392665|O1|Outcome|Erlotinib + Bevacizumab|"erlotinib plus bevacizumab~Bevacizumab: Given intravenously on day one of each 3 week cycle~erlotinib: Given orally once a day"
1168052|NCT00392665|O2|Outcome|Erlotinib + Sulindac|"erlotinib plus sulindac~erlotinib: Given orally once a day~Sulindac: Given orally twice a day"
1168053|NCT00392665|O1|Outcome|Erlotinib + Bevacizumab|"erlotinib plus bevacizumab~Bevacizumab: Given intravenously on day one of each 3 week cycle~erlotinib: Given orally once a day"
1168054|NCT00392665|E2|Reported Event|Erlotinib + Sulindac|"erlotinib plus sulindac~erlotinib: Given orally once a day~Sulindac: Given orally twice a day"
1168055|NCT00392665|E1|Reported Event|Erlotinib + Bevacizumab|"erlotinib plus bevacizumab~Bevacizumab: Given intravenously on day one of each 3 week cycle~erlotinib: Given orally once a day"
1168056|NCT00392496|B1|Baseline|Arm I|This is a non-randomized, open-label, multicenter study. Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
1168057|NCT00392496|P1|Participant Flow|Arm I|This is a non-randomized, open-label, multicenter study. Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
1168058|NCT00392496|O1|Outcome|Arm I|This is a non-randomized, open-label, multicenter study. Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
1168059|NCT00392496|E1|Reported Event|Arm I|This is a non-randomized, open-label, multicenter study. Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
1168060|NCT00392444|B1|Baseline|Treatment (Sunitinib Malate)|Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
1168061|NCT00392444|P1|Participant Flow|Treatment (Sunitinib Malate)|Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
1168062|NCT00392444|O1|Outcome|Treatment (Sunitinib Malate)|Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
1168063|NCT00392444|E1|Reported Event|Treatment (Sunitinib Malate)|Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
1168064|NCT00392392|B1|Baseline|Nab-Paclitaxel/Bevacizumab/Trastuzumab|Patients received treatment with nab-paclitaxel (100 mg/m2 IV days 1, 8, 15) and carboplatin (AUC 6 IV day 1) every 28 days for 6 cycles. Trastuzumab (4 mg/kg loading dose, followed by 2 mg/kg) and bevacizumab (5 mg/kg IV) were administered weekly for 23 weeks, beginning concurrently with chemotherapy. Patients then underwent either mastectomy or breast conserving surgery and pathologic treatment responses were assessed. After surgery, trastuzumab 6 mg/kg and bevacizumab 15 mg/kg were administered at 3 week intervals for a total of 52 weeks.
1168065|NCT00392392|P1|Participant Flow|Nab-Paclitaxel/Bevacizumab/Trastuzumab|Patients received treatment with nab-paclitaxel (100 mg/m2 IV days 1, 8, 15) and carboplatin (AUC 6 IV day 1) every 28 days for 6 cycles. Trastuzumab (4 mg/kg loading dose, followed by 2 mg/kg) and bevacizumab (5 mg/kg IV) were administered weekly for 23 weeks, beginning concurrently with chemotherapy. Patients then underwent either mastectomy or breast conserving surgery and pathologic treatment responses were assessed. After surgery, trastuzumab 6 mg/kg and bevacizumab 15 mg/kg were administered at 3 week intervals for a total of 52 weeks.
1168066|NCT00392392|O1|Outcome|Nab-Paclitaxel/Bevacizumab/Trastuzumab|Patients received treatment with nab-paclitaxel (100 mg/m2 IV days 1, 8, 15) and carboplatin (AUC 6 IV day 1) every 28 days for 6 cycles. Trastuzumab (4 mg/kg loading dose, followed by 2 mg/kg) and bevacizumab (5 mg/kg IV) were administered weekly for 23 weeks, beginning concurrently with chemotherapy. Patients then underwent either mastectomy or breast conserving surgery and pathologic treatment responses were assessed. After surgery, trastuzumab 6 mg/kg and bevacizumab 15 mg/kg were administered at 3 week intervals for a total of 52 weeks.
1168128|NCT00392210|B3|Baseline|Total|Total of all reporting groups
1169107|NCT00389519|O2|Outcome|Ramipril Low Dose|
1168067|NCT00392392|E1|Reported Event|Nab-Paclitaxel/Bevacizumab/Trastuzumab|Patients received treatment with nab-paclitaxel (100 mg/m2 IV days 1, 8, 15) and carboplatin (AUC 6 IV day 1) every 28 days for 6 cycles. Trastuzumab (4 mg/kg loading dose, followed by 2 mg/kg) and bevacizumab (5 mg/kg IV) were administered weekly for 23 weeks, beginning concurrently with chemotherapy. Patients then underwent either mastectomy or breast conserving surgery and pathologic treatment responses were assessed. After surgery, trastuzumab 6 mg/kg and bevacizumab 15 mg/kg were administered at 3 week intervals for a total of 52 weeks.
1168068|NCT00392379|B3|Baseline|Total|Total of all reporting groups
1168069|NCT00392379|B2|Baseline|Placebo Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
1168070|NCT00392379|B1|Baseline|Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
1168071|NCT00392379|P2|Participant Flow|Placebo Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
1168072|NCT00392379|P1|Participant Flow|Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
1168073|NCT00392379|O2|Outcome|Placebo Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
1168074|NCT00392379|O1|Outcome|Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
1168075|NCT00392379|O2|Outcome|Placebo Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
1168076|NCT00392379|O1|Outcome|Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
1168077|NCT00392379|O2|Outcome|Placebo Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
1168078|NCT00392379|O1|Outcome|Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
1168079|NCT00392379|E2|Reported Event|Placebo Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
1168080|NCT00392379|E1|Reported Event|Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
1168081|NCT00392288|B4|Baseline|Total|Total of all reporting groups
1168082|NCT00392288|B3|Baseline|Ciclesonide MDI 80 µg BID|Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
1168083|NCT00392288|B2|Baseline|Ciclesonide MDI 40 µg BID|Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
1168084|NCT00392288|B1|Baseline|Placebo Metered Dose Inhaler (MDI)|Placebo MDI over twelve weeks (ITT population)
1168085|NCT00392288|P3|Participant Flow|Ciclesonide MDI 80 µg BID|Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
1168086|NCT00392288|P2|Participant Flow|Ciclesonide MDI 40 µg BID|Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
1168087|NCT00392288|P1|Participant Flow|Placebo Metered Dose Inhaler (MDI)|Placebo MDI over twelve weeks (ITT population)
1168088|NCT00392288|O3|Outcome|Ciclesonide MDI 80 µg BID|Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
1168089|NCT00392288|O2|Outcome|Ciclesonide MDI 40 µg BID|Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
1168090|NCT00392288|O1|Outcome|Placebo Metered Dose Inhaler (MDI)|Placebo MDI over twelve weeks (ITT population)
1168091|NCT00392288|O3|Outcome|Ciclesonide MDI 80 µg BID|Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
1168092|NCT00392288|O2|Outcome|Ciclesonide MDI 40 µg BID|Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
1168093|NCT00392288|O1|Outcome|Placebo Metered Dose Inhaler (MDI)|Placebo MDI over twelve weeks (ITT population)
1168094|NCT00392288|O3|Outcome|Ciclesonide MDI 80 µg BID|Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
1168095|NCT00392288|O2|Outcome|Ciclesonide MDI 40 µg BID|Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
1168096|NCT00392288|O1|Outcome|Placebo Metered Dose Inhaler (MDI)|Placebo MDI over twelve weeks (ITT population)
1168097|NCT00392288|E3|Reported Event|Ciclesonide MDI 80 µg BID|Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
1168098|NCT00392288|E2|Reported Event|Ciclesonide MDI 40 µg BID|Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
1168099|NCT00392288|E1|Reported Event|Placebo Metered Dose Inhaler (MDI)|Placebo MDI over twelve weeks (ITT population)
1168100|NCT00392236|B3|Baseline|Total|Total of all reporting groups
1168101|NCT00392236|B2|Baseline|Treatment as Usual|"Participants will receive treatment as usual~Treatment as usual: Participants will receive treatment as usual."
1168102|NCT00392236|B1|Baseline|Pager Group|"Participants will receive treatment as usual and a 2-way pager for 6 months~2-way pager: Participants will receive messages daily to take their medication via a 2-way pager for 6 months. Once the message is received the participant will respond whether or not he/she took the medication and reason for not taking."
1168103|NCT00392236|P2|Participant Flow|Treatment as Usual|"Participants will receive treatment as usual~Treatment as usual: Participants will receive treatment as usual."
1168104|NCT00392236|P1|Participant Flow|Pager Group|"Participants will receive treatment as usual and a 2-way pager for 6 months~2-way pager: Participants will receive messages daily to take their medication via a 2-way pager for 6 months. Once the message is received the participant will respond whether or not he/she took the medication and reason for not taking."
1168105|NCT00392236|O2|Outcome|Treatment as Usual|"Participants will receive treatment as usual~Treatment as usual: Participants will receive treatment as usual."
1168106|NCT00392236|O1|Outcome|Pager Group|"Participants will receive treatment as usual and a 2-way pager for 6 months~2-way pager: Participants will receive messages daily to take their medication via a 2-way pager for 6 months. Once the message is received the participant will respond whether or not he/she took the medication and reason for not taking."
1168107|NCT00392236|E2|Reported Event|Treatment as Usual|"Participants will receive treatment as usual~Treatment as usual: Participants will receive treatment as usual."
1168108|NCT00392236|E1|Reported Event|Pager Group|"Participants will receive treatment as usual and a 2-way pager for 6 months~2-way pager: Participants will receive messages daily to take their medication via a 2-way pager for 6 months. Once the message is received the participant will respond whether or not he/she took the medication and reason for not taking."
1168109|NCT00392223|B3|Baseline|Total|Total of all reporting groups
1168110|NCT00392223|B2|Baseline|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
1168111|NCT00392223|B1|Baseline|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
1168112|NCT00392223|P2|Participant Flow|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
1168113|NCT00392223|P1|Participant Flow|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
1168114|NCT00392223|O2|Outcome|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
1168115|NCT00392223|O1|Outcome|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
1168116|NCT00392223|O2|Outcome|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
1168117|NCT00392223|O1|Outcome|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
1168118|NCT00392223|O2|Outcome|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
1168119|NCT00392223|O1|Outcome|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
1168120|NCT00392223|O2|Outcome|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
1168121|NCT00392223|O1|Outcome|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
1168122|NCT00392223|O2|Outcome|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
1168123|NCT00392223|O1|Outcome|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
1168124|NCT00392223|O2|Outcome|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
1168125|NCT00392223|O1|Outcome|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
1168126|NCT00392223|E2|Reported Event|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
1168127|NCT00392223|E1|Reported Event|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
1168129|NCT00392210|B2|Baseline|Back Fill Followed by Auto Fill|The back fill-method was performed immediately followed by the auto-fill method. Auto fill: The catheter was removed and the bladder was allowed to fill spontaneously until the patient experienced a strong urge to void. Back Fill: The bladder was filled retrograde through the indwelling Foley catheter with 300 cc sterile saline or until the patient reported a strong urge whichever occurred first.
1168130|NCT00392210|B1|Baseline|Auto Fill Followed by Back Fill|The Auto fill-method was performed immediately followed by the back-fill method. Auto fill: The catheter was removed and the bladder was allowed to fill spontaneously until the patient experienced a strong urge to void. Back Fill: The bladder was filled retrograde through the indwelling Foley catheter with 300 cc sterile saline or until the patient reported a strong urge whichever occurred first.
1168131|NCT00392210|P2|Participant Flow|Back Fill Followed by Autofill|The back fill-method was performed immediately followed by the auto-fill method. Auto fill: The catheter was removed and the bladder was allowed to fill spontaneously until the patient experienced a strong urge to void. Back Fill: The bladder was filled retrograde through the indwelling Foley catheter with 300 cc sterile saline or until the patient reported a strong urge whichever occurred first.
1168132|NCT00392210|P1|Participant Flow|Auto-fill Followed by Back Fill|The Auto fill-method was performed immediately followed by the back-fill method. Auto fill: The catheter was removed and the bladder was allowed to fill spontaneously until the patient experienced a strong urge to void. Back Fill: The bladder was filled retrograde through the indwelling Foley catheter with 300 cc sterile saline or until the patient reported a strong urge whichever occurred first.
1168133|NCT00392210|O2|Outcome|Back Fill Intervention|Back Fill: The bladder was filled retrograde through the indwelling Foley catheter with 300 cc sterile saline or until the patient reported a strong urge whichever occurred first.
1168134|NCT00392210|O1|Outcome|Auto Fill Intervention|Auto fill: The catheter was removed and the bladder was allowed to fill spontaneously until the patient experienced a strong urge to void.
1168135|NCT00392210|E2|Reported Event|Back Fill|Back Fill: The bladder was filled retrograde through the indwelling Foley catheter with 300 cc sterile saline or until the patient reported a strong urge whichever occurred first.
1168136|NCT00392210|E1|Reported Event|Auto Fill|Auto fill: The catheter was removed and the bladder was allowed to fill spontaneously until the patient experienced a strong urge to void.
1168137|NCT00392197|B3|Baseline|Total|Total of all reporting groups
1168138|NCT00392197|B2|Baseline|Patients Previously Treated With Antipsychotic Drugs|Patients who have taken antipsychotic drugs for 2 years or more and are taking antipsychotic drugs at the time of giving informed consent
1168139|NCT00392197|B1|Baseline|Antipsychotic-naïve Patients|Patients who have never taken antipsychotic drugs or patients who have taken antipsychotic drugs for less than 2 years and have not taken them within a period from at least 12 weeks prior to giving informed consent to immediately before commencement of study drug administration
1168140|NCT00392197|P2|Participant Flow|Patients Previously Treated With Antipsychotic Drugs|Patients who have taken antipsychotic drugs for 2 years or more and are taking antipsychotic drugs at the time of giving informed consent
1168141|NCT00392197|P1|Participant Flow|Antipsychotic-naïve Patients|Patients who have never taken antipsychotic drugs or patients who have taken antipsychotic drugs for less than 2 years and have not taken them within a period from at least 12 weeks prior to giving informed consent to immediately before commencement of study drug administration
1168142|NCT00392197|O2|Outcome|Patients Previously Treated With Antipsychotic Drugs|Patients who have taken antipsychotic drugs for 2 years or more and are taking antipsychotic drugs at the time of giving informed consent
1168143|NCT00392197|O1|Outcome|Antipsychotic-naïve Patients|Patients who have never taken antipsychotic drugs or patients who have taken antipsychotic drugs for less than 2 years and have not taken them within a period from at least 12 weeks prior to giving informed consent to immediately before commencement of study drug administration
1168144|NCT00392197|O2|Outcome|Patients Previously Treated With Antipsychotic Drugs|Patients who have taken antipsychotic drugs for 2 years or more and are taking antipsychotic drugs at the time of giving informed consent
1168145|NCT00392197|O1|Outcome|Antipsychotic-naïve Patients|Patients who have never taken antipsychotic drugs or patients who have taken antipsychotic drugs for less than 2 years and have not taken them within a period from at least 12 weeks prior to giving informed consent to immediately before commencement of study drug administration
1168146|NCT00392197|E2|Reported Event|Patients Previously Treated With Antipsychotic Drugs|Patients who have taken antipsychotic drugs for 2 years or more and are taking antipsychotic drugs at the time of giving informed consent
1168147|NCT00392197|E1|Reported Event|Antipsychotic-naïve Patients|Patients who have never taken antipsychotic drugs or patients who have taken antipsychotic drugs for less than 2 years and have not taken them within a period from at least 12 weeks prior to giving informed consent to immediately before commencement of study drug administration
1168148|NCT00392171|B1|Baseline|Temozolomide|Temozolomide will be administered at a dose of 50 mg/m^2 for cycles of 28 days for 12 months or until progression.
1168149|NCT00392171|P1|Participant Flow|Temozolomide|Temozolomide will be administered at a dose of 50 mg/m^2 for cycles of 28 days for 12 months or until progression.
1168150|NCT00392171|O1|Outcome|Temozolomide|Temozolomide will be administered at a dose of 50 mg/m^2 for cycles of 28 days for 12 months or until progression.
1168151|NCT00392171|E1|Reported Event|Temozolomide|
1168152|NCT00391989|B1|Baseline|Dasatinib|All patients registered in the study.
1168153|NCT00391989|P1|Participant Flow|Study Group|All patients registered in the study.
1168154|NCT00391989|O1|Outcome|Study Group|All patients registered in the study.
1168155|NCT00391989|E1|Reported Event|Dasatinib|All patients registered in the study.
1168156|NCT00391976|B4|Baseline|Total|Total of all reporting groups
1168157|NCT00391976|B3|Baseline|Non-randomized Patients|Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
1168158|NCT00391976|B2|Baseline|Tobramycin 300 mg for 56 Days|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
1168159|NCT00391976|B1|Baseline|Tobramycin 300 mg for 28 Days|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
1168160|NCT00391976|P3|Participant Flow|Non-randomized Patients|Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
1168161|NCT00391976|P2|Participant Flow|Tobramycin 300 mg for 56 Days|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
1168162|NCT00391976|P1|Participant Flow|Tobramycin 300 mg for 28 Days|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
1168163|NCT00391976|O3|Outcome|Non-randomized|Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
1168164|NCT00391976|O2|Outcome|Tobramycin 300 mg for 56 Days|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
1168165|NCT00391976|O1|Outcome|Tobramycin 300 mg for 28 Days|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
1168166|NCT00391976|O3|Outcome|Non-randomized|Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
1168167|NCT00391976|O2|Outcome|Tobramycin 300 mg for 56 Days|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
1168168|NCT00391976|O1|Outcome|Tobramycin 300 mg for 28 Days|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
1168169|NCT00391976|O3|Outcome|Non-randomized|Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
1168170|NCT00391976|O2|Outcome|Tobramycin 300 mg for 56 Days|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
1168171|NCT00391976|O1|Outcome|Tobramycin 300 mg for 28 Days|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
1168172|NCT00391976|O3|Outcome|Non-randomized|Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
1168173|NCT00391976|O2|Outcome|Tobramycin 300 mg for 56 Days|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
1168174|NCT00391976|O1|Outcome|Tobramycin 300 mg for 28 Days|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
1168175|NCT00391976|O3|Outcome|Non-randomized|Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
1168176|NCT00391976|O2|Outcome|Tobramycin 300 mg for 56 Days|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
1168177|NCT00391976|O1|Outcome|Tobramycin 300 mg for 28 Days|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
1168178|NCT00391976|E5|Reported Event|Tobramycin 56 Days After Month 3|Patients received tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. Patients received no study medication during the follow-up phase (from Month 3 though Month 27).
1168179|NCT00391976|E4|Reported Event|Tobramycin 28 Days After Month 3|Patients who received tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. Patients received no study medication during the follow-up phase (from Month 3 though Month 27).
1168180|NCT00391976|E3|Reported Event|Non-randomized Patients up to Month 3|Patients who started the study and received tobramycin 300 mg twice a day for 28 days but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups.
1168181|NCT00391976|E2|Reported Event|Tobramycin 56 Days Up To Month 3|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
1168182|NCT00391976|E1|Reported Event|Tobramycin 28 Days Up To Month 3|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
1168183|NCT00391898|B3|Baseline|Total|Total of all reporting groups
1168184|NCT00391898|B2|Baseline|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
1168185|NCT00391898|B1|Baseline|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
1168186|NCT00391898|P2|Participant Flow|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
1168187|NCT00391898|P1|Participant Flow|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
1168188|NCT00391898|O2|Outcome|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
1168189|NCT00391898|O1|Outcome|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
1168190|NCT00391898|O2|Outcome|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
1168191|NCT00391898|O1|Outcome|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
1168192|NCT00391898|O2|Outcome|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
1168193|NCT00391898|O1|Outcome|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
1168194|NCT00391898|O2|Outcome|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
1168195|NCT00391898|O1|Outcome|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
1168196|NCT00391898|O2|Outcome|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
1168197|NCT00391898|O1|Outcome|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
1168198|NCT00391898|O2|Outcome|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
1168199|NCT00391898|O1|Outcome|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
1168200|NCT00391898|O2|Outcome|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
1168201|NCT00391898|O1|Outcome|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
1168202|NCT00391898|E2|Reported Event|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
1168203|NCT00391898|E1|Reported Event|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
1168204|NCT00391872|B3|Baseline|Total|Total of all reporting groups
1168205|NCT00391872|B2|Baseline|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
1168206|NCT00391872|B1|Baseline|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
1168207|NCT00391872|P2|Participant Flow|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
1168208|NCT00391872|P1|Participant Flow|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
1168209|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
1168210|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
1168211|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
1168212|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
1168213|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
1168214|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
1168215|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
1168216|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
1168217|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
1168218|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
1168219|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
1168220|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
1168221|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
1168222|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
1168223|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
1168224|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
1168225|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
1168226|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
1168227|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
1168228|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
1168229|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
1168230|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
1168231|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
1168232|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
1168233|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
1168234|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
1168235|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
1168236|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
1168237|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
1168238|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
1168239|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
1168240|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
1168241|NCT00391872|E2|Reported Event|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
1168242|NCT00391872|E1|Reported Event|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
1168243|NCT00391846|B3|Baseline|Total|Total of all reporting groups
1168244|NCT00391846|B2|Baseline|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
1168245|NCT00391846|B1|Baseline|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
1168246|NCT00391846|P2|Participant Flow|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
1168247|NCT00391846|P1|Participant Flow|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
1168248|NCT00391846|O2|Outcome|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
1168249|NCT00391846|O1|Outcome|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
1168250|NCT00391846|O2|Outcome|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
1168251|NCT00391846|O1|Outcome|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
1168252|NCT00391846|O2|Outcome|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
1168253|NCT00391846|O1|Outcome|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
1168254|NCT00391846|O2|Outcome|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
1168255|NCT00391846|O1|Outcome|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
1168256|NCT00391846|O2|Outcome|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
1168257|NCT00391846|O1|Outcome|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
1168258|NCT00391846|O2|Outcome|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
1168259|NCT00391846|O1|Outcome|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
1168260|NCT00391846|O2|Outcome|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
1168261|NCT00391846|O1|Outcome|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
1168262|NCT00391846|O2|Outcome|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
1168263|NCT00391846|O1|Outcome|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
1168264|NCT00391846|E2|Reported Event|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
1168265|NCT00391846|E1|Reported Event|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
1168266|NCT00391807|B1|Baseline|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
1168267|NCT00391807|P1|Participant Flow|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
1168268|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
1168269|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
1168313|NCT00391768|O2|Outcome|Cohort IB|Subjects 12 to 23 months of age confirmed to have influenza and received 3.5 mg/kg of Oseltamivir by mouth twice a day times 5 days.
1168270|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
1168271|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
1168272|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
1168273|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
1168274|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
1168275|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
1168276|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
1168277|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
1168278|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
1168279|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
1168280|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
1168281|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
1168282|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
1168283|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
1168284|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
1168285|NCT00391807|E1|Reported Event|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
1168286|NCT00391768|B8|Baseline|Total|Total of all reporting groups
1168287|NCT00391768|B7|Baseline|Cohort V|0 to 2 months of age, 3 mg/kg body weight
1168288|NCT00391768|B6|Baseline|Cohort IV|3 to 5 months of age, 3 mg/kg body weight
1168289|NCT00391768|B5|Baseline|Cohort III|6 to 8 months of age, 3 mg/kg body weight
1168290|NCT00391768|B4|Baseline|Cohort IIB|9 to 11 months of age, 3.5 mg/kg body weight
1168291|NCT00391768|B3|Baseline|Cohort IIA|9 - 11 months of age, 3 mg/kg body weight
1168292|NCT00391768|B2|Baseline|Cohort IB|12 - 23 months of age, 3.5 mg/kg body weight
1168293|NCT00391768|B1|Baseline|Cohort IA|12 - 23 months of age, 30 mg
1168294|NCT00391768|P7|Participant Flow|Cohort V|0 to 2 months of age, 3 mg/kg body weight
1168295|NCT00391768|P6|Participant Flow|Cohort IV|3 to 5 months of age, 3 mg/kg body weight
1168296|NCT00391768|P5|Participant Flow|Cohort III|6 to 8 months of age, 3 mg/kg body weight
1168297|NCT00391768|P4|Participant Flow|Cohort IIB|9 to 11 months of age, 3.5 mg/kg body weight
1168298|NCT00391768|P3|Participant Flow|Cohort IIA|9 - 11 months of age, 3 mg/kg body weight
1168299|NCT00391768|P2|Participant Flow|Cohort IB|12 - 23 months of age, 3.5 mg/kg body weight
1168300|NCT00391768|P1|Participant Flow|Cohort IA|12 - 23 months of age, 30 mg
1168301|NCT00391768|O7|Outcome|Cohort V|0 to 2 months of age, 3 mg/kg body weight
1168302|NCT00391768|O6|Outcome|Cohort IV|3 to 5 months of age, 3 mg/kg body weight
1168303|NCT00391768|O5|Outcome|Cohort III|6 to 8 months of age, 3 mg/kg body weight
1168304|NCT00391768|O4|Outcome|Cohort IIB|9 to 11 months of age, 3.5 mg/kg body weight
1168305|NCT00391768|O3|Outcome|Cohort IIA|9 - 11 months of age, 3 mg/kg body weight
1168306|NCT00391768|O2|Outcome|Cohort IB|12 - 23 months of age, 3.5 mg/kg body weight
1168307|NCT00391768|O1|Outcome|Cohort IA|12 - 23 months of age, 30 mg
1168308|NCT00391768|O7|Outcome|Cohort V|Subjects 0 to 2 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
1168309|NCT00391768|O6|Outcome|Cohort IV|Subjects 3 to 5 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
1168310|NCT00391768|O5|Outcome|Cohort III|Subjects 6 to 8 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
1168311|NCT00391768|O4|Outcome|Cohort IIB|Subjects 9 to 11 months of age confirmed to have influenza and received 3.5 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
1168312|NCT00391768|O3|Outcome|Cohort IIA|Subjects 9 to 11 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
1168437|NCT00391599|E2|Reported Event|Control Group|"no preoperative intestinal preparation.~the night before cesarean section"
1168314|NCT00391768|O1|Outcome|Cohort IA|Subjects aged 12 to 23 months of age confirmed to have influenza. These subjects received 30mg of Oseltamivir twice a day times 5 days.
1168315|NCT00391768|O7|Outcome|Cohort V|0 to 2 months of age, 3 mg/kg body weight
1168316|NCT00391768|O6|Outcome|Cohort IV|3 to 5 months of age, 3 mg/kg body weight
1168317|NCT00391768|O5|Outcome|Cohort III|6 to 8 months of age, 3 mg/kg body weight
1168318|NCT00391768|O4|Outcome|Cohort IIB|9 to 11 months of age, 3.5 mg/kg body weight
1168319|NCT00391768|O3|Outcome|Cohort IIA|9 - 11 months of age, 3 mg/kg body weight
1168320|NCT00391768|O2|Outcome|Cohort IB|12 - 23 months of age, 3.5 mg/kg body weight
1168321|NCT00391768|O1|Outcome|Cohort IA|12 - 23 months of age, 30 mg
1168322|NCT00391768|O7|Outcome|Cohort V|0 to 2 months of age, 3 mg/kg body weight
1168323|NCT00391768|O6|Outcome|Cohort IV|3 to 5 months of age, 3 mg/kg body weight
1168324|NCT00391768|O5|Outcome|Cohort III|6 to 8 months of age, 3 mg/kg body weight
1168325|NCT00391768|O4|Outcome|Cohort IIB|9 to 11 months of age, 3.5 mg/kg body weight
1168326|NCT00391768|O3|Outcome|Cohort IIA|9 - 11 months of age, 3 mg/kg body weight
1168327|NCT00391768|O2|Outcome|Cohort IB|12 - 23 months of age, 3.5 mg/kg body weight
1168328|NCT00391768|O1|Outcome|Cohort IA|12 - 23 months of age, 30 mg
1168329|NCT00391768|O7|Outcome|Cohort V|0 to 2 months of age, 3 mg/kg body weight
1168330|NCT00391768|O6|Outcome|Cohort IV|3 to 5 months of age, 3 mg/kg body weight
1168331|NCT00391768|O5|Outcome|Cohort III|6 to 8 months of age, 3 mg/kg body weight
1168332|NCT00391768|O4|Outcome|Cohort IIB|9 to 11 months of age, 3.5 mg/kg body weight
1168333|NCT00391768|O3|Outcome|Cohort IIA|9 - 11 months of age, 3 mg/kg body weight
1168334|NCT00391768|O2|Outcome|Cohort IB|12 - 23 months of age, 3.5 mg/kg body weight
1168335|NCT00391768|O1|Outcome|Cohort IA|12 - 23 months of age, 30 mg
1168336|NCT00391768|O7|Outcome|Cohort V|Subjects aged 0 - 2 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days
1168337|NCT00391768|O6|Outcome|Cohort IV|Subjects aged 3 - 5 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days
1168338|NCT00391768|O5|Outcome|Cohort III|Subjects aged 6 - 8 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days
1168339|NCT00391768|O4|Outcome|Cohort IIB|Subjects aged 9 - 11 months of age confirmed to have influenza. These subjects received 3.5 mg/kg body weight of Oseltamivir twice a day times 5 days.
1168340|NCT00391768|O3|Outcome|Cohort IIA|Subjects aged 9 - 11 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days
1168341|NCT00391768|O2|Outcome|Cohort IB|Subjects aged 12 - 23 months of age confirmed to have influenza. These subjects received 3.5 mg/kg body weight of Oseltamivir twice a day times 5 days
1168342|NCT00391768|O1|Outcome|Cohort IA|Subjects aged 12 - 23 months of age confirmed to have influenza. These subjects received 30 mg of Oseltamivir twice a day times 5 days
1168343|NCT00391768|O7|Outcome|Cohort V|Subjects aged 0 - 2 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days
1168344|NCT00391768|O6|Outcome|Cohort IV|Subjects aged 3 - 5 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days
1168345|NCT00391768|O5|Outcome|Cohort III|Subjects aged 6 - 8 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days.
1168346|NCT00391768|O4|Outcome|Cohort IIB|Subjects aged 9 - 11 months of age confirmed to have influenza. These subjects received 3.5 mg/kg body weight of Oseltamivir twice a day times 5 days.
1168347|NCT00391768|O3|Outcome|Cohort IIA|Subjects aged 9 - 11 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days.
1168348|NCT00391768|O2|Outcome|Cohort IB|Subjects aged 12 - 23 months of age confirmed to have influenza. These subjects received 3.5 mg/kg body weight of Oseltamivir twice a day times 5 days.
1168349|NCT00391768|O1|Outcome|Cohort IA|Subjects aged 12 - 23 months of age confirmed to have influenza. These subjects received 30 mg of Oseltamivir twice a day times 5 days.
1168350|NCT00391768|O7|Outcome|Cohort V|Subjects 0 to 2 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
1168351|NCT00391768|O6|Outcome|Cohort IV|Subjects 3 to 5 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
1168352|NCT00391768|O5|Outcome|Cohort III|Subjects 6 to 8 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
1168353|NCT00391768|O4|Outcome|Cohort IIB|Subjects 9 to 11 months of age confirmed to have influenza and received 3.5 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
1168354|NCT00391768|O3|Outcome|Cohort IIA|Subjects 9 to 11 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
1168355|NCT00391768|O2|Outcome|Cohort IB|Subjects 12 to 23 months of age confirmed to have influenza and received 3.5 mg/kg of Oseltamivir by mouth twice a day times 5 days.
1168356|NCT00391768|O1|Outcome|Cohort IA|Subjects aged 12 to 23 months of age confirmed to have influenza. These subjects received 30mg of Oseltamivir twice a day times 5 days.
1168357|NCT00391768|E7|Reported Event|Cohort V|0 to 2 months of age, 3 mg/kg body weight
1168358|NCT00391768|E6|Reported Event|Cohort IV|3 to 5 months of age, 3 mg/kg body weight
1168359|NCT00391768|E5|Reported Event|Cohort III|6 to 8 months of age, 3 mg/kg body weight
1168360|NCT00391768|E4|Reported Event|Cohort IIB|9 to 11 months of age, 3.5 mg/kg body weight
1168361|NCT00391768|E3|Reported Event|Cohort IIA|9 - 11 months of age, 3 mg/kg body weight
1168362|NCT00391768|E2|Reported Event|Cohort IB|12 - 23 months of age, 3.5 mg/kg body weight
1168363|NCT00391768|E1|Reported Event|Cohort IA|12 - 23 months of age, 30 mg
1168364|NCT00391716|B4|Baseline|Total|Total of all reporting groups
1168542|NCT00391222|B3|Baseline|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine 10 mg/day
1168365|NCT00391716|B3|Baseline|Placebo Daily|"placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~placebo: lactose capsule compounded to mimic gabapentin capsules"
1168366|NCT00391716|B2|Baseline|Gabapentin 1800mg Daily|"1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks"
1168367|NCT00391716|B1|Baseline|Gabapentin 900mg Daily|"900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info."
1168368|NCT00391716|P3|Participant Flow|Placebo Daily|"placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~placebo: lactose capsule compounded to mimic gabapentin capsules"
1168369|NCT00391716|P2|Participant Flow|Gabapentin 1800mg Daily|"1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks"
1168370|NCT00391716|P1|Participant Flow|Gabapentin 900mg Daily|"900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info."
1168371|NCT00391716|O3|Outcome|Placebo Daily|"placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~placebo: lactose capsule compounded to mimic gabapentin capsules"
1168372|NCT00391716|O2|Outcome|Gabapentin 1800mg Daily|"1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks"
1168373|NCT00391716|O1|Outcome|Gabapentin 900mg Daily|"900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info."
1168374|NCT00391716|O3|Outcome|Placebo Daily|"placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~placebo: lactose capsule compounded to mimic gabapentin capsules"
1168375|NCT00391716|O2|Outcome|Gabapentin 1800mg Daily|"1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks"
1168376|NCT00391716|O1|Outcome|Gabapentin 900mg Daily|"900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info."
1168377|NCT00391716|O3|Outcome|Placebo Daily|"placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~placebo: lactose capsule compounded to mimic gabapentin capsules"
1168378|NCT00391716|O2|Outcome|Gabapentin 1800mg Daily|"1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks"
1168379|NCT00391716|O1|Outcome|Gabapentin 900mg Daily|"900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info."
1168380|NCT00391716|O3|Outcome|Placebo Daily|"placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~placebo: lactose capsule compounded to mimic gabapentin capsules"
1168381|NCT00391716|O2|Outcome|Gabapentin 1800mg Daily|"1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks"
1168382|NCT00391716|O1|Outcome|Gabapentin 900mg Daily|"900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info."
1168438|NCT00391599|E1|Reported Event|Study Group|"a fleet enema (250 cc of sodium biphosphate 16 gr and sodium phosphate 6 gr per 100 cc) the night before cesarean section~enema~the night before cesarean section"
1168383|NCT00391716|E3|Reported Event|Placebo Daily|"placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~placebo: lactose capsule compounded to mimic gabapentin capsules"
1168384|NCT00391716|E2|Reported Event|Gabapentin 1800mg Daily|"1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks"
1168385|NCT00391716|E1|Reported Event|Gabapentin 900mg Daily|"900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info."
1168386|NCT00391625|B1|Baseline|GA-GCB|15-60 U/kg every other week via intravenous infusion
1168387|NCT00391625|P1|Participant Flow|GA-GCB|15-60 U/kg every other week via intravenous infusion
1168388|NCT00391625|O6|Outcome|GA-GCB: Month 81|15-60 U/kg, every other week Intravenously
1168389|NCT00391625|O5|Outcome|GA-GCB: Month 69|15-60 U/kg, every other week Intravenously
1168390|NCT00391625|O4|Outcome|GA-GCB: Month 57|15-60 U/kg, every other week Intravenously
1168391|NCT00391625|O3|Outcome|GA-GCB: Month 45|15-60 U/kg, every other week Intravenously
1168392|NCT00391625|O2|Outcome|GA-GCB: Month 33|15-60 U/kg, every other week Intravenously
1168393|NCT00391625|O1|Outcome|GA-GCB: Month 24|15-60 U/kg, every other week Intravenously
1168394|NCT00391625|O6|Outcome|GA-GCB: Month 81|15-60 U/kg, every other week Intravenously
1168395|NCT00391625|O5|Outcome|GA-GCB: Month 69|15-60 U/kg, every other week Intravenously
1168396|NCT00391625|O4|Outcome|GA-GCB: Month 57|15-60 U/kg, every other week Intravenously
1168397|NCT00391625|O3|Outcome|GA-GCB: Month 45|15-60 U/kg, every other week Intravenously
1168398|NCT00391625|O2|Outcome|GA-GCB: Month 33|15-60 U/kg, every other week Intravenously
1168399|NCT00391625|O1|Outcome|GA-GCB: Month 24|15-60 U/kg, every other week Intravenously
1168400|NCT00391625|O7|Outcome|GA-GCB: 84 Months|15-60 U/kg, every other week Intravenously
1168401|NCT00391625|O6|Outcome|GA-GCB: 72 Months|15-60 U/kg, every other week Intravenously
1168402|NCT00391625|O5|Outcome|GA-GCB: 60 Months|15-60 U/kg, every other week Intravenously
1168403|NCT00391625|O4|Outcome|GA-GCB-48 Months|15-60 U/kg, every other week Intravenously
1168404|NCT00391625|O3|Outcome|GA-GCB: 36 Months|15-60 U/kg, every other week Intravenously
1168405|NCT00391625|O2|Outcome|GA-GCB: 24 Months|15-60 U/kg, every other week Intravenously
1168406|NCT00391625|O1|Outcome|GA-GCB: 12 Months|15-60 U/kg, every other week Intravenously
1168407|NCT00391625|O7|Outcome|GA-GCB: 84 Months|15-60 U/kg, every other week Intravenously
1168408|NCT00391625|O6|Outcome|GA-GCB: 72 Months|15-60 U/kg, every other week Intravenously
1168409|NCT00391625|O5|Outcome|GA-GCB: 60 Months|15-60 U/kg, every other week Intravenously
1168410|NCT00391625|O4|Outcome|GA-GCB-48 Months|15-60 U/kg, every other week Intravenously
1168411|NCT00391625|O3|Outcome|GA-GCB: 36 Months|15-60 U/kg, every other week Intravenously
1168412|NCT00391625|O2|Outcome|GA-GCB: 24 Months|15-60 U/kg, every other week Intravenously
1168413|NCT00391625|O1|Outcome|GA-GCB: 12 Months|15-60 U/kg, every other week Intravenously
1168414|NCT00391625|O11|Outcome|# Deaths|
1168415|NCT00391625|O10|Outcome|# Discontinued Due to an AE|15-60 U/kg, every other week Intravenously
1168416|NCT00391625|O9|Outcome|# Experienced at Least 1 Drug-related Serious AE|15-60 U/kg, every other week Intravenously
1168417|NCT00391625|O8|Outcome|# Experienced at Least 1 Serious AE|15-60 U/kg, every other week Intravenously
1168418|NCT00391625|O7|Outcome|# Experienced at Least 1 Life-threatening AE|15-60 U/kg, every other week Intravenously
1168419|NCT00391625|O6|Outcome|# Experienced at Least 1 Drug-related Severe AE|15-60 U/kg, every other week Intravenously
1168420|NCT00391625|O5|Outcome|# Experienced at Least 1 Severe AE|15-60 U/kg, every other week Intravenously
1168421|NCT00391625|O4|Outcome|# Experienced at Least 1 Infusion-related AE|15-60 U/kg, every other week Intravenously
1168422|NCT00391625|O3|Outcome|# Experienced at Least 1 Drug-related AE|15-60 U/kg, every other week Intravenously
1168423|NCT00391625|O2|Outcome|# Experienced at Least 1 AE|15-60 U/kg, every other week Intravenously
1168424|NCT00391625|O1|Outcome|Number (#) Experienced no Adverse Event (AE)|15-60 U/kg every other week via intravenous infusion
1168425|NCT00391625|E1|Reported Event|GA-GCB|
1168426|NCT00391599|B3|Baseline|Total|Total of all reporting groups
1168427|NCT00391599|B2|Baseline|Control Group|no preoperative intestinal preparation.
1168428|NCT00391599|B1|Baseline|Study Group|"a fleet enema (250 cc of sodium biphosphate 16 gr and sodium phosphate 6 gr per 100 cc) the night before cesarean section~enema"
1168429|NCT00391599|P2|Participant Flow|Control Group|The patients had no preoperative intestinal preparation on the night before cesarean section
1168430|NCT00391599|P1|Participant Flow|Study Group|The patients were given a Fleet enema (250 cm3 of sodium biphosphate 16 g and sodium phosphate 6 g/100 cm3) the night before cesarean section
1168431|NCT00391599|O2|Outcome|Control Group|The patients had no preoperative intestinal preparation on the night before cesarean section
1168432|NCT00391599|O1|Outcome|Study Group|The patients were given a Fleet enema (250 cm3 of sodium biphosphate 16 g and sodium phosphate 6 g/100 cm3) the night before cesarean section
1168433|NCT00391599|O2|Outcome|Control Group|"no preoperative intestinal preparation.~enema"
1168434|NCT00391599|O1|Outcome|Study Group|"a fleet enema (250 cc of sodium biphosphate 16 gr and sodium phosphate 6 gr per 100 cc) the night before cesarean section~enema"
1168435|NCT00391599|O2|Outcome|Control Group|The patients had no preoperative intestinal preparation on the night before cesarean section
1168436|NCT00391599|O1|Outcome|Study Group|The patients were given a Fleet enema (250 cm3 of sodium biphosphate 16 g and sodium phosphate 6 g/100 cm3) the night before cesarean section
1168509|NCT00391365|B3|Baseline|Total|Total of all reporting groups
1168439|NCT00391586|B1|Baseline|Erlotinib Followed by Chemotherapy|Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
1168440|NCT00391586|P1|Participant Flow|Erlotinib Followed by Chemotherapy|Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
1168441|NCT00391586|O1|Outcome|Erlotinib Followed by Chemotherapy|Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
1168442|NCT00391586|O1|Outcome|Erlotinib Followed by Chemotherapy|Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
1168443|NCT00391586|E1|Reported Event|Erlotinib Followed by Chemotherapy|Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
1168444|NCT00391469|B5|Baseline|Total|Total of all reporting groups
1168445|NCT00391469|B4|Baseline|Non-VF-randomized to Hypothermia|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.~Rapid infusion of cold normal saline"
1168446|NCT00391469|B3|Baseline|Non-VF Randomized to Standard Treatment|standard treatment following non-VF cardiac arrest
1168447|NCT00391469|B2|Baseline|VF-randomized to Hypothermia|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.~Rapid infusion of cold normal saline"
1168448|NCT00391469|B1|Baseline|VF-randomized to Standard Treatment|standard treatment following VF cardiac arrest
1168449|NCT00391469|P2|Participant Flow|Control|standard of care
1168450|NCT00391469|P1|Participant Flow|Intervention|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.~Rapid infusion of cold normal saline"
1168451|NCT00391469|O4|Outcome|Non-VF-randomized to Hypothermia|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.~Rapid infusion of cold normal saline"
1168452|NCT00391469|O3|Outcome|Non-VF Randomized to Standard Treatment|standard treatment following non-VF cardiac arrest
1168453|NCT00391469|O2|Outcome|VF-randomized to Hypothermia|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.~Rapid infusion of cold normal saline"
1168454|NCT00391469|O1|Outcome|VF-randomized to Standard Treatment|standard treatment following VF cardiac arrest
1168455|NCT00391469|O4|Outcome|Non-VF-randomized to Hypothermia|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.~Rapid infusion of cold normal saline"
1168456|NCT00391469|O3|Outcome|Non-VF Randomized to Standard Treatment|standard treatment following non-VF cardiac arrest
1168457|NCT00391469|O2|Outcome|VF-randomized to Hypothermia|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.~Rapid infusion of cold normal saline"
1168458|NCT00391469|O1|Outcome|VF-randomized to Standard Treatment|standard treatment following VF cardiac arrest
1168459|NCT00391469|E2|Reported Event|Control-standard Care|standard care
1168460|NCT00391469|E1|Reported Event|Intervention-hypo|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.~Rapid infusion of cold normal saline"
1168461|NCT00391443|B3|Baseline|Total|Total of all reporting groups
1168462|NCT00391443|B2|Baseline|Bosentan|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
1168463|NCT00391443|B1|Baseline|Placebo|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
1168464|NCT00391443|P2|Participant Flow|Bosentan|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
1168465|NCT00391443|P1|Participant Flow|Placebo|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
1168466|NCT00391443|O2|Outcome|Bosentan|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
1168541|NCT00391222|B4|Baseline|Total|Total of all reporting groups
1168813|NCT00390689|B4|Baseline|Total|Total of all reporting groups
1168467|NCT00391443|O1|Outcome|Placebo|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
1168468|NCT00391443|O2|Outcome|Bosentan|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
1168469|NCT00391443|O1|Outcome|Placebo|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
1168470|NCT00391443|E2|Reported Event|Bosentan|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
1168471|NCT00391443|E1|Reported Event|Placebo|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
1168472|NCT00391391|B5|Baseline|Total|Total of all reporting groups
1168473|NCT00391391|B4|Baseline|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
1168474|NCT00391391|B3|Baseline|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
1168475|NCT00391391|B2|Baseline|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
1168476|NCT00391391|B1|Baseline|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
1168477|NCT00391391|P4|Participant Flow|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
1168478|NCT00391391|P3|Participant Flow|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
1168479|NCT00391391|P2|Participant Flow|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
1168480|NCT00391391|P1|Participant Flow|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
1168481|NCT00391391|O4|Outcome|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
1168482|NCT00391391|O3|Outcome|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
1168483|NCT00391391|O2|Outcome|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
1168484|NCT00391391|O1|Outcome|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
1168485|NCT00391391|O4|Outcome|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
1168486|NCT00391391|O3|Outcome|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
1168487|NCT00391391|O2|Outcome|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
1168488|NCT00391391|O1|Outcome|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
1168489|NCT00391391|O4|Outcome|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
1168490|NCT00391391|O3|Outcome|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
1168491|NCT00391391|O2|Outcome|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
1168492|NCT00391391|O1|Outcome|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
1168493|NCT00391391|O4|Outcome|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
1168494|NCT00391391|O3|Outcome|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
1168495|NCT00391391|O2|Outcome|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
1168496|NCT00391391|O1|Outcome|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
1168497|NCT00391391|O4|Outcome|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
1168498|NCT00391391|O3|Outcome|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
1168499|NCT00391391|O2|Outcome|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
1168500|NCT00391391|O1|Outcome|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
1168501|NCT00391391|O4|Outcome|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
1168502|NCT00391391|O3|Outcome|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
1168503|NCT00391391|O2|Outcome|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
1168504|NCT00391391|O1|Outcome|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
1168505|NCT00391391|E4|Reported Event|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
1168506|NCT00391391|E3|Reported Event|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
1168507|NCT00391391|E2|Reported Event|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
1168508|NCT00391391|E1|Reported Event|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
1168510|NCT00391365|B2|Baseline|Ankle Arthroplasty (Replacement)|"Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis~Gait analysis: Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras."
1168511|NCT00391365|B1|Baseline|Ankle Arthrodesis (Fusion)|"Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis~Gait analysis: Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras."
1168512|NCT00391365|P2|Participant Flow|Ankle Arthroplasty (Replacement)|"Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis~Gait analysis: Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras."
1168513|NCT00391365|P1|Participant Flow|Ankle Arthrodesis (Fusion)|"Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis~Gait analysis: Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras."
1168514|NCT00391365|O2|Outcome|Ankle Arthroplasty (Replacement)|Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis.
1168515|NCT00391365|O1|Outcome|Ankle Arthrodesis (Fusion)|Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis
1168516|NCT00391365|O2|Outcome|Ankle Arthroplasty (Replacement)|Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis.
1168517|NCT00391365|O1|Outcome|Ankle Arthrodesis (Fusion)|Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis
1168518|NCT00391365|O2|Outcome|Ankle Arthroplasty (Replacement)|Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis
1168519|NCT00391365|O1|Outcome|Ankle Arthrodesis (Fusion)|Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis
1168520|NCT00391365|E2|Reported Event|Ankle Arthroplasty (Replacement)|"Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis~Gait analysis: Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras."
1168521|NCT00391365|E1|Reported Event|Ankle Arthrodesis (Fusion)|"Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis~Gait analysis: Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras."
1168522|NCT00391274|B3|Baseline|Total|Total of all reporting groups
1168523|NCT00391274|B2|Baseline|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
1168524|NCT00391274|B1|Baseline|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
1168525|NCT00391274|P2|Participant Flow|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
1168526|NCT00391274|P1|Participant Flow|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
1168527|NCT00391274|O2|Outcome|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
1168528|NCT00391274|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
1168529|NCT00391274|O2|Outcome|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
1168530|NCT00391274|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
1168531|NCT00391274|O2|Outcome|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
1168532|NCT00391274|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
1168533|NCT00391274|O2|Outcome|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
1168534|NCT00391274|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
1168535|NCT00391274|O2|Outcome|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
1168536|NCT00391274|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
1168537|NCT00391274|O2|Outcome|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
1168538|NCT00391274|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
1168539|NCT00391274|E2|Reported Event|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
1168540|NCT00391274|E1|Reported Event|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
1168543|NCT00391222|B2|Baseline|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
1168544|NCT00391222|B1|Baseline|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable intramuscular every 14 days and oral placebo daily
1168545|NCT00391222|P4|Participant Flow|Open-label Risperidone LAI|Open-label Period II: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days
1168546|NCT00391222|P3|Participant Flow|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
1168547|NCT00391222|P2|Participant Flow|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
1168548|NCT00391222|P1|Participant Flow|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
1168549|NCT00391222|O1|Outcome|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
1168550|NCT00391222|O3|Outcome|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
1168551|NCT00391222|O2|Outcome|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
1168552|NCT00391222|O1|Outcome|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
1168553|NCT00391222|O3|Outcome|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
1168554|NCT00391222|O2|Outcome|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
1168555|NCT00391222|O1|Outcome|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
1168556|NCT00391222|O3|Outcome|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
1168557|NCT00391222|O2|Outcome|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
1168558|NCT00391222|O1|Outcome|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
1168559|NCT00391222|O3|Outcome|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
1168560|NCT00391222|O2|Outcome|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
1168561|NCT00391222|O1|Outcome|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
1168562|NCT00391222|O3|Outcome|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
1168563|NCT00391222|O2|Outcome|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
1168564|NCT00391222|O1|Outcome|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
1168565|NCT00391222|O2|Outcome|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
1168566|NCT00391222|O1|Outcome|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
1168567|NCT00391222|E4|Reported Event|Open-label Risperidone LAI|risperidone 25, 37.5, or 50 mg intramuscular every 14 days
1168568|NCT00391222|E3|Reported Event|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
1168569|NCT00391222|E2|Reported Event|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
1168570|NCT00391222|E1|Reported Event|Risperidone LAI|Double-blind Period III: risperidone LAI 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
1168571|NCT00391092|B3|Baseline|Total|Total of all reporting groups
1168572|NCT00391092|B2|Baseline|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
1168573|NCT00391092|B1|Baseline|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
1168574|NCT00391092|P2|Participant Flow|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
1168575|NCT00391092|P1|Participant Flow|Trastuzumab + Docetaxel|Trastuzumab 8 milligrams per kilogram (mg/kg) loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 milligrams per square meter (mg/m^2) on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
1168576|NCT00391092|O2|Outcome|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
1168627|NCT00391053|O3|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3
1169205|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
1168577|NCT00391092|O1|Outcome|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
1168578|NCT00391092|O2|Outcome|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
1168579|NCT00391092|O1|Outcome|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
1168580|NCT00391092|O2|Outcome|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
1168581|NCT00391092|O1|Outcome|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
1168582|NCT00391092|O2|Outcome|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
1168583|NCT00391092|O1|Outcome|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
1168584|NCT00391092|O2|Outcome|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
1168585|NCT00391092|O1|Outcome|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
1168586|NCT00391092|O2|Outcome|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
1168587|NCT00391092|O1|Outcome|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
1168588|NCT00391092|O2|Outcome|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
1168589|NCT00391092|O1|Outcome|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
1168590|NCT00391092|E2|Reported Event|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
1168628|NCT00391053|O2|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2
1169919|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1168591|NCT00391092|E1|Reported Event|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
1168592|NCT00391079|B3|Baseline|Total|Total of all reporting groups
1168593|NCT00391079|B2|Baseline|Placebo|Range of 8-12 sprays per day of placebo spray.
1168594|NCT00391079|B1|Baseline|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
1168595|NCT00391079|P2|Participant Flow|Placebo|Range of 8-12 sprays per day of placebo spray.
1168596|NCT00391079|P1|Participant Flow|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
1168597|NCT00391079|O2|Outcome|Placebo|Range of 8-12 sprays of placebo per day
1168598|NCT00391079|O1|Outcome|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
1168599|NCT00391079|O2|Outcome|Placebo|Range of 8-12 sprays of placebo per day
1168600|NCT00391079|O1|Outcome|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
1168601|NCT00391079|O2|Outcome|Placebo|Range of 8-12 sprays of placebo per day
1168602|NCT00391079|O1|Outcome|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
1168603|NCT00391079|O2|Outcome|Placebo|Range of 8-12 sprays of placebo per day
1168604|NCT00391079|O1|Outcome|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
1168605|NCT00391079|O2|Outcome|Placebo|Range of 8-12 sprays of placebo per day
1168606|NCT00391079|O1|Outcome|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
1168607|NCT00391079|O2|Outcome|Placebo|Range of 8-12 sprays of placebo per day
1168608|NCT00391079|O1|Outcome|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
1168609|NCT00391079|O2|Outcome|Placebo|Range of 8-12 sprays of placebo per day
1168610|NCT00391079|O1|Outcome|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
1168611|NCT00391079|E2|Reported Event|Placebo|Range of 8-12 sprays of placebo per day
1168612|NCT00391079|E1|Reported Event|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
1168613|NCT00391053|B5|Baseline|Total|Total of all reporting groups
1168614|NCT00391053|B4|Baseline|Active Comparator (Standard Fluzone®)|Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
1168615|NCT00391053|B3|Baseline|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3
1168616|NCT00391053|B2|Baseline|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2
1168617|NCT00391053|B1|Baseline|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1
1168618|NCT00391053|P4|Participant Flow|Active Comparator (Standard Fluzone®)|Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
1168619|NCT00391053|P3|Participant Flow|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3
1168620|NCT00391053|P2|Participant Flow|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2
1168621|NCT00391053|P1|Participant Flow|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1
1168622|NCT00391053|O4|Outcome|Active Comparator (Standard Fluzone®)|Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
1168623|NCT00391053|O3|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3
1168624|NCT00391053|O2|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2
1168625|NCT00391053|O1|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1
1168626|NCT00391053|O4|Outcome|Active Comparator (Standard Fluzone®)|Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
1169053|NCT00389818|P1|Participant Flow|DR-COP|Single arm interventional study: all subjects receive Doxil, Rituximab, Cyclophosphamide, Vincristine and Prednisone (DR-COP) regimen.
1168629|NCT00391053|O1|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1
1168630|NCT00391053|O4|Outcome|Active Comparator (Standard Fluzone®)|Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
1168631|NCT00391053|O3|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3
1168632|NCT00391053|O2|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2
1168633|NCT00391053|O1|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1
1168634|NCT00391053|O4|Outcome|Active Comparator (Standard Fluzone®)|Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
1168635|NCT00391053|O3|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3
1168636|NCT00391053|O2|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2
1168637|NCT00391053|O1|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1
1168638|NCT00391053|E4|Reported Event|Standad Dose Inactivated, Split-Virion Influenza Vaccine|
1168639|NCT00391053|E3|Reported Event|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3|
1168640|NCT00391053|E2|Reported Event|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2|
1168641|NCT00391053|E1|Reported Event|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1|
1168642|NCT00391027|B3|Baseline|Total|Total of all reporting groups
1168643|NCT00391027|B2|Baseline|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
1168644|NCT00391027|B1|Baseline|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
1168645|NCT00391027|P2|Participant Flow|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
1168646|NCT00391027|P1|Participant Flow|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
1168647|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
1168648|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
1168649|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
1168650|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
1169108|NCT00389519|O1|Outcome|Placebo|
1168651|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
1168652|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
1168653|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
1168654|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
1168655|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
1168656|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
1168657|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
1168658|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
1168659|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
1168660|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
1168661|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
1168662|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
1168694|NCT00390884|E2|Reported Event|Fluzone®-Naive Group|Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
1169206|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1168663|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
1168664|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
1168665|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
1168666|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
1168667|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
1168668|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
1168669|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
1168670|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
1168671|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
1168672|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
1168673|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
1168674|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
1168695|NCT00390884|E1|Reported Event|Fluzone®-Primed Group|Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
1168696|NCT00390858|B3|Baseline|Total|Total of all reporting groups
1168675|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
1168676|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
1168677|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
1168678|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
1168679|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
1168680|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
1168681|NCT00391027|E2|Reported Event|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
1168682|NCT00391027|E1|Reported Event|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
1168683|NCT00390884|B3|Baseline|Total|Total of all reporting groups
1168684|NCT00390884|B2|Baseline|Fluzone®-Naive Group|Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
1168685|NCT00390884|B1|Baseline|Fluzone®-Primed Group|Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
1168686|NCT00390884|P2|Participant Flow|Fluzone®-Naive Group|Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
1168687|NCT00390884|P1|Participant Flow|Fluzone®-Primed Group|Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
1168688|NCT00390884|O2|Outcome|Fluzone®-Naive Group|Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
1168689|NCT00390884|O1|Outcome|Fluzone®-Primed Group|Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
1168690|NCT00390884|O2|Outcome|Fluzone®-Naive Group|Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
1168691|NCT00390884|O1|Outcome|Fluzone®-Primed Group|Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
1168692|NCT00390884|O2|Outcome|Fluzone®-Naive Group|Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
1168693|NCT00390884|O1|Outcome|Fluzone®-Primed Group|Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
1169920|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1168697|NCT00390858|B2|Baseline|Adolescents ( ≧12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
1168698|NCT00390858|B1|Baseline|Children (<12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
1168699|NCT00390858|P2|Participant Flow|Adolescents ( ≧12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
1168700|NCT00390858|P1|Participant Flow|Children ( < 12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
1168701|NCT00390858|O2|Outcome|Adolescents ( ≧12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
1168702|NCT00390858|O1|Outcome|Children (<12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
1168703|NCT00390858|O2|Outcome|Adolescents ( ≧12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
1168704|NCT00390858|O1|Outcome|Children (<12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
1168705|NCT00390858|O2|Outcome|Adolescents ( ≧12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
1168706|NCT00390858|O1|Outcome|Children (<12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
1168707|NCT00390858|O2|Outcome|Adolescents ( ≧12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
1168708|NCT00390858|O1|Outcome|Children (<12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
1168709|NCT00390858|E2|Reported Event|Adolescents ( ≧12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters ( renal and hematology) and whether Liver Iron Concentration (LIC) and serum ferritin were increasing or decreasing
1168710|NCT00390858|E1|Reported Event|Children (<12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters ( renal and hematology) and whether Liver Iron Concentration (LIC) and serum ferritin were increasing or decreasing
1168711|NCT00390806|B3|Baseline|Total|Total of all reporting groups
1168712|NCT00390806|B2|Baseline|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168713|NCT00390806|B1|Baseline|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168714|NCT00390806|P2|Participant Flow|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168799|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
1168800|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
1168715|NCT00390806|P1|Participant Flow|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168716|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168717|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168718|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168719|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168720|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168721|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168722|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168723|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168724|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168725|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168726|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168727|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168728|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168801|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
1168802|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
1168803|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
1168729|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168730|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168731|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168732|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168733|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168734|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168735|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168736|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168737|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168738|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168739|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168740|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168741|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168742|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168804|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
1168805|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
1168806|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
1168743|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168744|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168745|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168746|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168747|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168748|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168749|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168750|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168751|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168752|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168753|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168754|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168755|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168756|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168807|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
1168808|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
1168809|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
1169921|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1168757|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168758|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168759|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168760|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168761|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168762|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168763|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168764|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168765|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168766|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168767|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168768|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168769|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168770|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168810|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
1168811|NCT00390780|E2|Reported Event|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
1168812|NCT00390780|E1|Reported Event|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
1168771|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168772|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168773|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168774|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168775|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168776|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168777|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168778|NCT00390806|E2|Reported Event|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
1168779|NCT00390806|E1|Reported Event|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
1168780|NCT00390780|B3|Baseline|Total|Total of all reporting groups
1168781|NCT00390780|B2|Baseline|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
1168782|NCT00390780|B1|Baseline|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
1168783|NCT00390780|P2|Participant Flow|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day, for 14 days
1168784|NCT00390780|P1|Participant Flow|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
1168785|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
1168786|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
1168787|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
1168788|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
1168789|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
1168790|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
1168791|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
1168792|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
1168793|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
1168794|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
1168795|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
1168796|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
1168797|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
1168798|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
1168814|NCT00390689|B3|Baseline|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168815|NCT00390689|B2|Baseline|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168816|NCT00390689|B1|Baseline|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168817|NCT00390689|P3|Participant Flow|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168818|NCT00390689|P2|Participant Flow|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168819|NCT00390689|P1|Participant Flow|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168820|NCT00390689|O4|Outcome|Pramipexole 0.75mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168821|NCT00390689|O3|Outcome|Pramipexole 0.5mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168908|NCT00390559|B1|Baseline|All Participants|In this study, overnight abstinent smokers completed four, double-blind laboratory sessions corresponding to a 2x2 design where transdermal nicotine dose (TN, 0 or 21 mg) was crossed with type of cigarette (nicotine-containing [NIC] or not [DENIC]). Cigarettes were smoked 4 hours after TN administration.
1169207|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
1168822|NCT00390689|O2|Outcome|Pramipexole 0.25mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168823|NCT00390689|O1|Outcome|Pramipexole 0.125mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168824|NCT00390689|O4|Outcome|Pramipexole 0.75mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168825|NCT00390689|O3|Outcome|Pramipexole 0.5mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168826|NCT00390689|O2|Outcome|Pramipexole 0.25mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168827|NCT00390689|O1|Outcome|Pramipexole 0.125mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168828|NCT00390689|O4|Outcome|Pramipexole 0.75mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168829|NCT00390689|O3|Outcome|Pramipexole 0.5mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168830|NCT00390689|O2|Outcome|Pramipexole 0.25mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168831|NCT00390689|O1|Outcome|Pramipexole 0.125mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168832|NCT00390689|O4|Outcome|Pramipexole 0.75mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1169262|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1168833|NCT00390689|O3|Outcome|Pramipexole 0.5mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168834|NCT00390689|O2|Outcome|Pramipexole 0.25mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168835|NCT00390689|O1|Outcome|Pramipexole 0.125mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168836|NCT00390689|O4|Outcome|Pramipexole 0.75mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168837|NCT00390689|O3|Outcome|Pramipexole 0.5mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168838|NCT00390689|O2|Outcome|Pramipexole 0.25mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168839|NCT00390689|O1|Outcome|Pramipexole 0.125mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168840|NCT00390689|O4|Outcome|Pramipexole 0.75mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168841|NCT00390689|O3|Outcome|Pramipexole 0.50mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168842|NCT00390689|O2|Outcome|Pramipexole 0.25mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168843|NCT00390689|O1|Outcome|Pramipexole 0.125mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1169480|NCT00387881|O1|Outcome|Placebo|
1168844|NCT00390689|O4|Outcome|Pramipexole 0.75mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168845|NCT00390689|O3|Outcome|Pramipexole 0.5mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168846|NCT00390689|O2|Outcome|Pramipexole 0.25mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168847|NCT00390689|O1|Outcome|Pramipexole 0.125mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168848|NCT00390689|O3|Outcome|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168849|NCT00390689|O2|Outcome|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168850|NCT00390689|O1|Outcome|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168851|NCT00390689|O3|Outcome|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168852|NCT00390689|O2|Outcome|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1169054|NCT00389818|O1|Outcome|DR-COP|Single arm interventional study: all subjects receive Doxil, Rituximab, Cyclophosphamide, Vincristine and Prednisone (DR-COP) regimen.
1168853|NCT00390689|O1|Outcome|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168854|NCT00390689|O3|Outcome|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168855|NCT00390689|O2|Outcome|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168856|NCT00390689|O1|Outcome|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168857|NCT00390689|O3|Outcome|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168858|NCT00390689|O2|Outcome|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168859|NCT00390689|O1|Outcome|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168860|NCT00390689|O3|Outcome|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168861|NCT00390689|O2|Outcome|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168862|NCT00390689|O1|Outcome|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168863|NCT00390689|O3|Outcome|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168864|NCT00390689|O2|Outcome|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168865|NCT00390689|O1|Outcome|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168866|NCT00390689|O3|Outcome|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168867|NCT00390689|O2|Outcome|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168868|NCT00390689|O1|Outcome|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168869|NCT00390689|E7|Reported Event|Pramipexole 0.75mg (Open Label)|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168870|NCT00390689|E6|Reported Event|Pramipexole 0.50mg (Open Label)|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168871|NCT00390689|E5|Reported Event|Pramipexole 0.25mg (Open Label)|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168872|NCT00390689|E4|Reported Event|Pramipexole 0.125mg (Open Label)|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
1168873|NCT00390689|E3|Reported Event|Pramipexole 0.75mg (Double-blind)|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily"
1168874|NCT00390689|E2|Reported Event|Pramipexole 0.50mg (Double-blind)|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily"
1168875|NCT00390689|E1|Reported Event|Pramipexole 0.25mg (Double-blind)|"Double-blind period: 0.25 mg randomised group.~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily"
1168876|NCT00390611|B3|Baseline|Total|Total of all reporting groups
1168877|NCT00390611|B2|Baseline|Paclitaxel/Carboplatin|"Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV~Paclitaxel: Paclitaxel~Carboplatin: Carboplatin"
1168878|NCT00390611|B1|Baseline|Paclitaxel/Carboplatin/Sorafenib|"Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid~Sorafenib~Paclitaxel: Paclitaxel~Carboplatin: Carboplatin"
1168879|NCT00390611|P2|Participant Flow|Paclitaxel/Carboplatin|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
1168880|NCT00390611|P1|Participant Flow|Paclitaxel/Carboplatin/Sorafenib|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid
1168881|NCT00390611|O2|Outcome|Paclitaxel/Carboplatin|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
1168882|NCT00390611|O1|Outcome|Paclitaxel/Carboplatin/Sorafenib|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid
1168883|NCT00390611|O2|Outcome|Paclitaxel/Carboplatin|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
1168884|NCT00390611|O1|Outcome|Paclitaxel/Carboplatin/Sorafenib|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid
1168885|NCT00390611|O2|Outcome|Paclitaxel/Carboplatin|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
1168886|NCT00390611|O1|Outcome|Paclitaxel/Carboplatin/Sorafenib|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid
1168887|NCT00390611|O2|Outcome|Paclitaxel/Carboplatin|"Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV~Paclitaxel: Paclitaxel~Carboplatin: Carboplatin"
1168888|NCT00390611|O1|Outcome|Paclitaxel/Carboplatin/Sorafenib|"Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid~Sorafenib~Paclitaxel: Paclitaxel~Carboplatin: Carboplatin"
1168889|NCT00390611|E2|Reported Event|Paclitaxel/Carboplatin|"Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV~Paclitaxel: Paclitaxel~Carboplatin: Carboplatin"
1168890|NCT00390611|E1|Reported Event|Paclitaxel/Carboplatin/Sorafenib|"Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid~Sorafenib~Paclitaxel: Paclitaxel~Carboplatin: Carboplatin"
1168891|NCT00390572|B3|Baseline|Total|Total of all reporting groups
1168892|NCT00390572|B2|Baseline|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
1169198|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
1169037|NCT00389831|O7|Outcome|Rotigotine Nasal Spray - Rotigotine 124µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 124µg nasal spray on Day 3.
1168893|NCT00390572|B1|Baseline|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study~Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants� primary care providers."
1168894|NCT00390572|P2|Participant Flow|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
1168895|NCT00390572|P1|Participant Flow|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study~Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants' primary care providers."
1168896|NCT00390572|O2|Outcome|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
1168897|NCT00390572|O1|Outcome|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study~Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants� primary care providers."
1168898|NCT00390572|O2|Outcome|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
1168899|NCT00390572|O1|Outcome|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study~Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants� primary care providers."
1168900|NCT00390572|O2|Outcome|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
1168901|NCT00390572|O1|Outcome|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study~Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants� primary care providers."
1168902|NCT00390572|O2|Outcome|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
1168903|NCT00390572|O1|Outcome|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study~Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants� primary care providers."
1168904|NCT00390572|O2|Outcome|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
1168905|NCT00390572|O1|Outcome|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study~Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants� primary care providers."
1168906|NCT00390572|E2|Reported Event|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
1168907|NCT00390572|E1|Reported Event|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study~Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants� primary care providers."
1169922|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1168909|NCT00390559|P1|Participant Flow|All Participants|In this study, overnight abstinent smokers completed four, double-blind laboratory sessions corresponding to a 2x2 design where transdermal nicotine dose (TN, 0 or 21 mg) was crossed with type of cigarette (nicotine-containing [NIC] or not [DENIC]). Cigarettes were smoked 4 hours after TN administration.
1168910|NCT00390559|O4|Outcome|PlaceboP/PlaceboC|0 mg patch/no nicotine cigarette
1168911|NCT00390559|O3|Outcome|Active P/PlaceboC|21 mg patch/no nicotine cigarette
1168912|NCT00390559|O2|Outcome|PlaceboP/ActiveC|0 mg patch/nicotine-containing cigarette
1168913|NCT00390559|O1|Outcome|ActiveP/ActiveC|21 mg patch/Nicotine-containing cigarette
1168914|NCT00390559|E4|Reported Event|PlaceboP/PlaceboC|0 mg patch/no nicotine cigarette
1168915|NCT00390559|E3|Reported Event|Active P/PlaceboC|21 mg patch/no nicotine cigarette
1168916|NCT00390559|E2|Reported Event|PlaceboP/ActiveC|0 mg patch/nicotine-containing cigarette
1168917|NCT00390559|E1|Reported Event|ActiveP/ActiveC|21 mg patch/Nicotine-containing cigarette
1168918|NCT00390546|B3|Baseline|Total|Total of all reporting groups
1168919|NCT00390546|B2|Baseline|Propranolol|The study drug was given for 6 months or until one of the study end points was reached. To account for differences in pharmacokinetics, the drug was administered orally at 0.5 mg/kg per dose as a single dose and increased to 1.0 mg/kg per dose TID for the second and subsequent doses.
1168920|NCT00390546|B1|Baseline|Digoxin|The study drug was given for 6 months or until one of the study end points was reached. To account for differences in pharmacokinetics, the first 2 doses of digoxin were administered oraly at 0.010 mg/kg per dose TID, then 0.0035 mg/kg per dose TID for the third and subsequent doses.
1168921|NCT00390546|P2|Participant Flow|Propranolol|The study drug was given for 6 months or until one of the study end points was reached. To account for differences in pharmacokinetics, the drug was administered orally at 0.5 mg/kg per dose as a single dose and increased to 1.0 mg/kg per dose TID for the second and subsequent doses.
1168922|NCT00390546|P1|Participant Flow|Digoxin|The study drug was given for 6 months or until one of the study end points was reached. To account for differences in pharmacokinetics, the first 2 doses of digoxin were administered oraly at 0.010 mg/kg per dose TID, then 0.0035 mg/kg per dose TID for the third and subsequent doses.
1168923|NCT00390546|O2|Outcome|Propranolol|Single dose administered at 0.5 mg/kg per dose as a single dose and increased to 1.0 mg/kg per dose TID for the second and subsequent doses.
1168924|NCT00390546|O1|Outcome|Digoxin|The first 2 doses of digoxin were administered orally at 0.010 mg/kg per dose TID, then 0.0035 mg/kg per dose TID for the third and subsequent doses.
1168925|NCT00390546|O2|Outcome|Propranolol|Single dose administered orally at 0.5/kg per dose and increased to 1.0 mg/kg per dose TID for the second and subsequent doses.
1168926|NCT00390546|O1|Outcome|Digoxin|The first 2 doses of digoxin were administered orally at 0.010 mg/kg per dose TID, then 0.0035 mg/kg per dose TID for the third and subsequent doses.
1168927|NCT00390546|O2|Outcome|Propranolol|Single dose administered at 0.5 mg/kg per dose as a single dose and increased to 1.0 mg/kg per dose TID for the second and subsequent doses.
1168928|NCT00390546|O1|Outcome|Digoxin|The first 2 doses of digoxin were administered orally at 0.010 mg/kg per dose TID, then 0.0035 mg/kg per dose TID for the third and subsequent doses.
1168929|NCT00390546|E2|Reported Event|Propranolol|
1168930|NCT00390546|E1|Reported Event|Digoxin|
1168931|NCT00390468|B1|Baseline|Tandutinib (MLN518)|500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases
1168932|NCT00390468|P1|Participant Flow|Tandutinib (MLN518)|500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases
1168933|NCT00390468|O1|Outcome|Tandutinib (MLN518)|500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases
1168934|NCT00390468|E1|Reported Event|Tandutinib (MLN518)|500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases
1168956|NCT00390416|B1|Baseline|Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin|Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
1168957|NCT00390416|P1|Participant Flow|Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin|"Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin~Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin: Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes"
1168958|NCT00390416|O1|Outcome|Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin|Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
1168959|NCT00390416|O1|Outcome|Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin|Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
1168960|NCT00390416|O1|Outcome|Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin|Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
1168961|NCT00390416|E1|Reported Event|Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin|Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
1168962|NCT00390364|B1|Baseline|RAD0001|Eligible patients will be treated with single agent RAD 001 at doses on 10 mg per day orally. Tumor samples will be obtained before and after treatment by means of fine needle aspirate (FNA)-guided tumor biopsies. Treatment effects will be determined by serial MRI scans. Patients will continue treatment until tumor progression or intolerable toxicity.
1168963|NCT00390364|P1|Participant Flow|RAD0001|Eligible patients will be treated with single agent RAD 001 at doses on 10 mg per day orally. Tumor samples will be obtained before and after treatment by means of fine needle aspirate (FNA)-guided tumor biopsies. Treatment effects will be determined by serial MRI scans. Patients will continue treatment until tumor progression or intolerable toxicity.
1168964|NCT00390364|O1|Outcome|RAD0001|Eligible patients will be treated with single agent RAD 001 at doses on 10 mg per day orally. Tumor samples will be obtained before and after treatment by means of fine needle aspirate (FNA)-guided tumor biopsies. Treatment effects will be determined by serial MRI scans. Patients will continue treatment until tumor progression or intolerable toxicity.
1168965|NCT00390364|E1|Reported Event|RAD0001|Eligible patients will be treated with single agent RAD 001 at doses on 10 mg per day orally. Tumor samples will be obtained before and after treatment by means of fine needle aspirate (FNA)-guided tumor biopsies. Treatment effects will be determined by serial MRI scans. Patients will continue treatment until tumor progression or intolerable toxicity.
1168966|NCT00390234|B1|Baseline|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1168967|NCT00390234|P1|Participant Flow|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1168968|NCT00390234|O1|Outcome|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV"
1168969|NCT00390234|O1|Outcome|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV"
1168970|NCT00390234|O1|Outcome|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV"
1168971|NCT00390234|O1|Outcome|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV"
1168972|NCT00390234|O1|Outcome|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1169199|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
1168973|NCT00390234|E1|Reported Event|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1168974|NCT00390221|B4|Baseline|Total|Total of all reporting groups
1168975|NCT00390221|B3|Baseline|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
1168976|NCT00390221|B2|Baseline|150 mg DAC HYP|150 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
1168977|NCT00390221|B1|Baseline|Placebo|Placebo administered as 3 SC injections every 4 weeks for up to 52 weeks
1168978|NCT00390221|P3|Participant Flow|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
1168979|NCT00390221|P2|Participant Flow|150 mg DAC HYP|150 mg Daclizumab High Yield Process (DAC HYP) administered as 3 SC injections every 4 weeks for up to 52 weeks
1168980|NCT00390221|P1|Participant Flow|Placebo|Placebo administered as 3 subcutaneous (SC) injections every 4 weeks for up to 52 weeks
1168981|NCT00390221|O3|Outcome|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
1168982|NCT00390221|O2|Outcome|150 mg DAC HYP|150 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
1168983|NCT00390221|O1|Outcome|Placebo|Placebo administered as 3 SC injections every 4 weeks for up to 52 weeks
1168984|NCT00390221|O3|Outcome|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
1168985|NCT00390221|O2|Outcome|150 mg DAC HYP|150 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
1168986|NCT00390221|O1|Outcome|Placebo|Placebo administered as 3 SC injections every 4 weeks for up to 52 weeks
1168987|NCT00390221|O3|Outcome|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
1168988|NCT00390221|O2|Outcome|150 mg DAC HYP|150 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
1168989|NCT00390221|O1|Outcome|Placebo|Placebo administered as 3 SC injections every 4 weeks for up to 52 weeks
1168990|NCT00390221|O3|Outcome|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
1168991|NCT00390221|O2|Outcome|150 mg DAC HYP|150 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
1168992|NCT00390221|O1|Outcome|Placebo|Placebo administered as 3 SC injections every 4 weeks for up to 52 weeks
1168993|NCT00390221|O3|Outcome|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
1168994|NCT00390221|O2|Outcome|150 mg DAC HYP|150 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
1168995|NCT00390221|O1|Outcome|Placebo|Placebo administered as 3 SC injections every 4 weeks for up to 52 weeks
1168996|NCT00390221|E4|Reported Event|Total Active|150 mg or 300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
1168997|NCT00390221|E3|Reported Event|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
1168998|NCT00390221|E2|Reported Event|150 mg DAC HYP|150 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
1168999|NCT00390221|E1|Reported Event|Placebo|Placebo administered as 3 SC injections every 4 weeks for up to 52 weeks
1169000|NCT00390182|B1|Baseline|Standard Chemotherapy, Gemcitabine With Concurrent Low Dose Ra|
1169001|NCT00390182|P1|Participant Flow|Gem(1250mg/m2, d1, 8) +LDFRT (60cGy/fx BID, d1,2,8,9)|4 cycles (1 cycle = 21 days): Gemcitabine 1250/m2 given IV Day 1 and Day 8; with concurrent Low Dose Fractionated Radiation Therapy (LDFRT). The total Radiation dose would be 19.2 Gy divided over 32 fractions. Treatment will be given in 2 fractions with a minimum 4 hr inter-fraction interval, not to exceed 6 hours. Radiotherapy given after the initiation of Gemcitabine Days 1,2,8, and 9.
1169002|NCT00390182|O1|Outcome|Low Dose Fractionated Radiation Therapy (LDFRT) + Gemcitabine|Use of LDFRT with systemic gemcitabine is safe, tolerable, and potentially effective. In advanced pancreatic cancer, where response rates with single agent gemcitabine have been low, this chemopotentiation paradigm may improve survival among a poor prognostic patient cohort.
1169003|NCT00390182|O1|Outcome|Low Dose Fractionated Radiation Therapy (LDFRT) + Gemcitabine|Use of LDFRT with systemic gemcitabine is safe, tolerable, and potentially effective. In advanced pancreatic cancer, where response rates with single agent gemcitabine have been low, this chemopotentiation paradigm may improve survival among a poor prognostic patient cohort.
1169004|NCT00390182|O1|Outcome|Low Dose Fractionated Radiation Therapy (LDFRT) + Gemcitabine|Use of LDFRT with systemic gemcitabine is safe, tolerable, and potentially effective. In advanced pancreatic cancer, where response rates with single agent gemcitabine have been low, this chemopotentiation paradigm may improve survival among a poor prognostic patient cohort.
1169005|NCT00390182|E1|Reported Event|Standard Chemotherapy, Gemcitabine With Concurrent Low Dose Ra|
1169006|NCT00389974|B1|Baseline|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO daily for 4 weeks. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR may receive 2 courses after CR or PR is reached.~sunitinib malate: Given PO"
1169007|NCT00389974|P1|Participant Flow|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO daily for 4 weeks. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR may receive 2 courses after CR or PR is reached.~sunitinib malate: Given PO"
1169008|NCT00389974|O1|Outcome|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO daily for 4 weeks. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR may receive 2 courses after CR or PR is reached.~sunitinib malate: Given PO"
1169009|NCT00389974|E1|Reported Event|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO daily for 4 weeks. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR may receive 2 courses after CR or PR is reached.~sunitinib malate: Given PO"
1169010|NCT00389857|B3|Baseline|Total|Total of all reporting groups
1169011|NCT00389857|B2|Baseline|Influenza Vaccine-Primed Group|Participants have received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0.
1169012|NCT00389857|B1|Baseline|Influenza Vaccine-Naive Group|Participants have never received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0 and Day 28, respectively.
1169013|NCT00389857|P2|Participant Flow|Influenza Vaccine-Primed Group|Participants have received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0.
1169014|NCT00389857|P1|Participant Flow|Influenza Vaccine-Naive Group|Participants have never received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0 and Day 28, respectively.
1169015|NCT00389857|O2|Outcome|Influenza Vaccine-Primed Group|Subjects have received Influenza virus vaccine in the past
1169016|NCT00389857|O1|Outcome|Influenza Vaccine-Naive Group|Subjects have never received Influenza virus vaccine
1169017|NCT00389857|O2|Outcome|Influenza Vaccine-Primed Group|Subjects have received Influenza virus vaccine in the past
1169018|NCT00389857|O1|Outcome|Influenza Vaccine-Naive Group|Subjects have never received Influenza virus vaccine
1169019|NCT00389857|O2|Outcome|Influenza Vaccine-Primed Group|Subjects have received Influenza virus vaccine in the past
1169020|NCT00389857|O1|Outcome|Influenza Vaccine-Naive Group|Subjects have never received Influenza virus vaccine
1169021|NCT00389857|E2|Reported Event|Influenza Vaccine-Primed Group|Participants have received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0.
1169022|NCT00389857|E1|Reported Event|Influenza Vaccine-Naive Group|Participants have never received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0 and Day 28, respectively.
1169023|NCT00389831|B3|Baseline|Total|Total of all reporting groups
1169024|NCT00389831|B2|Baseline|Rotigotine Nasal Spray|Subjects receiving doses of placebo nasal spray on Day 1 or Day 2, Rotigotine nasal spray 62µg on Day 1 or Day 2, Rotigotine nasal spray 124µg on Day 3, and Rotigotine nasal spray 247µg on Day 4
1169025|NCT00389831|B1|Baseline|Placebo|Subjects receiving a single dose of placebo nasal spray on all 4 treatment days
1169026|NCT00389831|P2|Participant Flow|Rotigotine Nasal Spray|Subjects receiving doses of placebo nasal spray on Day 1 or Day 2, Rotigotine nasal spray 62µg on Day 1 or Day 2, Rotigotine nasal spray 124µg on Day 3, and Rotigotine nasal spray 247µg on Day 4
1169027|NCT00389831|P1|Participant Flow|Placebo|Subjects receiving a single dose of placebo nasal spray on all 4 treatment days
1169028|NCT00389831|O8|Outcome|Rotigotine Nasal Spray - Rotigotine 247µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 247µg nasal spray on Day 4.
1169029|NCT00389831|O7|Outcome|Rotigotine Nasal Spray - Rotigotine 124µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 124µg nasal spray on Day 3.
1169030|NCT00389831|O6|Outcome|Rotigotine Nasal Spray - Rotigotine 62µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 62µg nasal spray on Day 1 or Day 2.
1169031|NCT00389831|O5|Outcome|Rotigotine Nasal Spray - Placebo|Subjects randomized to rotigotine nasal spray arm receiving a single dose of placebo nasal spray on Day 1 or Day 2.
1169032|NCT00389831|O4|Outcome|Placebo - Day 4|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 4.
1169033|NCT00389831|O3|Outcome|Placebo - Day 3|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 3.
1169034|NCT00389831|O2|Outcome|Placebo - Day 2|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 2.
1169035|NCT00389831|O1|Outcome|Placebo - Day 1|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 1.
1169036|NCT00389831|O8|Outcome|Rotigotine Nasal Spray - Rotigotine 247µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 247µg nasal spray on Day 4.
1169105|NCT00389519|O4|Outcome|Ramipril High Dose|
1169106|NCT00389519|O3|Outcome|Ramipril Mid Dose|
1169038|NCT00389831|O6|Outcome|Rotigotine Nasal Spray - Rotigotine 62µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 62µg nasal spray on Day 1 or Day 2.
1169039|NCT00389831|O5|Outcome|Rotigotine Nasal Spray - Placebo|Subjects randomized to rotigotine nasal spray arm receiving a single dose of placebo nasal spray on Day 1 or Day 2.
1169040|NCT00389831|O4|Outcome|Placebo - Day 4|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 4.
1169041|NCT00389831|O3|Outcome|Placebo - Day 3|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 3.
1169042|NCT00389831|O2|Outcome|Placebo - Day 2|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 2.
1169043|NCT00389831|O1|Outcome|Placebo - Day 1|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 1.
1169044|NCT00389831|E8|Reported Event|Rotigotine Nasal Spray - Rotigotine 247µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 247µg nasal spray on Day 4.
1169045|NCT00389831|E7|Reported Event|Rotigotine Nasal Spray - Rotigotine 124µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 124µg nasal spray on Day 3.
1169046|NCT00389831|E6|Reported Event|Rotigotine Nasal Spray - Rotigotine 62µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 62µg nasal spray on Day 1 or Day 2.
1169047|NCT00389831|E5|Reported Event|Rotigotine Nasal Spray - Placebo|Subjects randomized to rotigotine nasal spray arm receiving a single dose of placebo nasal spray on Day 1 or Day 2.
1169048|NCT00389831|E4|Reported Event|Placebo - Day 4|Subjects randomized to placebo treatment group, receiving a single dose of placebo nasal spray on Day 4.
1169049|NCT00389831|E3|Reported Event|Placebo - Day 3|Subjects randomized to placebo treatment group, receiving a single dose of placebo nasal spray on Day 3.
1169050|NCT00389831|E2|Reported Event|Placebo - Day 2|Subjects randomized to placebo treatment group, receiving a single dose of placebo nasal spray on Day 2.
1169051|NCT00389831|E1|Reported Event|Placebo - Day 1|Subjects randomized to placebo treatment group, receiving a single dose of placebo nasal spray on Day 1.
1169052|NCT00389818|B1|Baseline|DR-COP|Single arm interventional study: all subjects receive Doxil, Rituximab, Cyclophosphamide, Vincristine and Prednisone (DR-COP) regimen.
1169055|NCT00389818|E1|Reported Event|DR-COP|Single arm interventional study: all subjects receive Doxil, Rituximab, Cyclophosphamide, Vincristine and Prednisone (DR-COP) regimen.
1169056|NCT00389597|B5|Baseline|Total|Total of all reporting groups
1169057|NCT00389597|B4|Baseline|2 Level ACDF|
1169058|NCT00389597|B3|Baseline|2 Level TDR|
1169059|NCT00389597|B2|Baseline|1 Level ACDF|
1169060|NCT00389597|B1|Baseline|1 Level TDR|
1169061|NCT00389597|P4|Participant Flow|2 Level ACDF Arm|2 level control procedure (ACDF)
1169062|NCT00389597|P3|Participant Flow|2 Level TDR Arm|Cervical artificial disc (investigational device) at 2 levels
1169063|NCT00389597|P2|Participant Flow|1 Level ACDF Arm|1 level control procedure (ACDF)
1169064|NCT00389597|P1|Participant Flow|1 Level TDR Arm|Cervical artificial disc (investigational device) at 1 level
1169065|NCT00389597|O4|Outcome|2 Level TDR|control procedure (ACDF) at two levels
1169066|NCT00389597|O3|Outcome|2 Level ACDF|Cervical artificial disc (investigational device) at 2 levels compared with control procedure (ACDF) at two levels
1169067|NCT00389597|O2|Outcome|1 Level TDR|Cervical artificial disc (investigational device) at 1 level
1169068|NCT00389597|O1|Outcome|1 Level ACDF|control procedure (ACDF) at one level
1169069|NCT00389597|E4|Reported Event|2 Level ACDF Arm|
1169070|NCT00389597|E3|Reported Event|2 Level TDR Arm|Cervical artificial disc (investigational device) at 2 levels
1169071|NCT00389597|E2|Reported Event|1 Level ACDF Arm|
1169072|NCT00389597|E1|Reported Event|1 Level TDR Arm|Cervical artificial disc (investigational device) at 1 level
1169073|NCT00389532|B3|Baseline|Total|Total of all reporting groups
1169074|NCT00389532|B2|Baseline|Aged ≥ 60 Years|Participants aged 60 years and older at enrollment
1169075|NCT00389532|B1|Baseline|Aged 18 to 59 Years|Participants aged 18 to 59 years at enrollment
1169076|NCT00389532|P2|Participant Flow|Aged ≥ 60 Years|Participants aged 60 years and older at enrollment
1169077|NCT00389532|P1|Participant Flow|Aged 18 to 59 Years|Participants aged 18 to 59 years at enrollment
1169078|NCT00389532|O2|Outcome|Aged ≥ 60 Years|Participants aged 60 years and older at enrollment
1169079|NCT00389532|O1|Outcome|Aged 18 to 59 Years|Participants aged 18 to 59 years at enrollment
1169080|NCT00389532|O2|Outcome|Aged ≥ 60 Years|Participants aged 60 years and older at enrollment
1169081|NCT00389532|O1|Outcome|Aged 18 to 59 Years|Participants aged 18 to 59 years at enrollment
1169082|NCT00389532|E2|Reported Event|Aged ≥ 60 Years|Participants aged 60 years and older at enrollment
1169083|NCT00389532|E1|Reported Event|Aged 18 to 59 Years|Participants aged 18 to 59 years at enrollment
1169084|NCT00389519|B5|Baseline|Total|Total of all reporting groups
1169085|NCT00389519|B4|Baseline|Ramipril High Dose|
1169086|NCT00389519|B3|Baseline|Ramipril Mid Dose|
1169087|NCT00389519|B2|Baseline|Ramipril Low Dose|
1169088|NCT00389519|B1|Baseline|Placebo|
1169089|NCT00389519|P4|Participant Flow|Ramipril High Dose|
1169090|NCT00389519|P3|Participant Flow|Ramipril Mid Dose|
1169091|NCT00389519|P2|Participant Flow|Ramipril Low Dose|
1169092|NCT00389519|P1|Participant Flow|Placebo|
1169093|NCT00389519|O4|Outcome|Ramipril High Dose|
1169094|NCT00389519|O3|Outcome|Ramipril Mid Dose|
1169095|NCT00389519|O2|Outcome|Ramipril Low Dose|
1169096|NCT00389519|O1|Outcome|Placebo|
1169097|NCT00389519|O4|Outcome|Ramipril High Dose|
1169098|NCT00389519|O3|Outcome|Ramipril Mid Dose|
1169099|NCT00389519|O2|Outcome|Ramipril Low Dose|
1169100|NCT00389519|O1|Outcome|Placebo|
1169101|NCT00389519|O4|Outcome|Ramipril High Dose|
1169102|NCT00389519|O3|Outcome|Ramipril Mid Dose|
1169103|NCT00389519|O2|Outcome|Ramipril Low Dose|
1169104|NCT00389519|O1|Outcome|Placebo|
1169109|NCT00389519|O4|Outcome|Ramipril High Dose|
1169110|NCT00389519|O3|Outcome|Ramipril Mid Dose|
1169111|NCT00389519|O2|Outcome|Ramipril Low Dose|
1169112|NCT00389519|O1|Outcome|Placebo|
1169113|NCT00389519|E4|Reported Event|Ramipril High Dose|
1169114|NCT00389519|E3|Reported Event|Ramipril Mid Dose|
1169115|NCT00389519|E2|Reported Event|Ramipril Low Dose|
1169116|NCT00389519|E1|Reported Event|Placebo|
1169117|NCT00389493|B4|Baseline|Total|Total of all reporting groups
1169118|NCT00389493|B3|Baseline|Treatment With Pill Placebo|"Participants will receive treatment with the placebo~Placebo : Placebo capsules will be identical in appearance to those of risperidone."
1169119|NCT00389493|B2|Baseline|Treatment With Exposure/Response Prevention|"Participants will receive exposure and response prevention therapy~Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response."
1169120|NCT00389493|B1|Baseline|Treatment With Risperidone|"Participants will receive treatment with risperidone~Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated"
1169121|NCT00389493|P3|Participant Flow|Treatment With Pill Placebo|"Participants will receive treatment with the placebo~Placebo : Placebo capsules will be identical in appearance to those of risperidone."
1169122|NCT00389493|P2|Participant Flow|Treatment With Exposure/Response Prevention|"Participants will receive exposure and response prevention therapy~Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response."
1169123|NCT00389493|P1|Participant Flow|Treatment With Risperidone|"Participants will receive treatment with risperidone~Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated"
1169200|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169124|NCT00389493|O3|Outcome|Treatment With Pill Placebo|"Participants will receive treatment with the placebo~Placebo : Placebo capsules will be identical in appearance to those of risperidone."
1169125|NCT00389493|O2|Outcome|Treatment With Exposure/Response Prevention|"Participants will receive exposure and response prevention therapy~Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response."
1169126|NCT00389493|O1|Outcome|Treatment With Risperidone|"Participants will receive treatment with risperidone~Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated"
1169127|NCT00389493|O3|Outcome|Treatment With Pill Placebo|"Participants will receive treatment with the placebo~Placebo : Placebo capsules will be identical in appearance to those of risperidone."
1169128|NCT00389493|O2|Outcome|Treatment With Exposure/Response Prevention|"Participants will receive exposure and response prevention therapy~Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response."
1169129|NCT00389493|O1|Outcome|Treatment With Risperidone|"Participants will receive treatment with risperidone~Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated"
1169130|NCT00389493|O3|Outcome|Treatment With Pill Placebo|"Participants received treatment with the placebo~Placebo : Placebo capsules will be identical in appearance to those of risperidone.~Mean Y-BOCS score measured at week 8"
1169131|NCT00389493|O2|Outcome|Treatment With Exposure/Response Prevention|"Participants received exposure and response prevention therapy~Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.~Mean Y-BOCS score measured at week 8"
1169132|NCT00389493|O1|Outcome|Treatment With Risperidone|Participants received treatment with risperidone Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated Mean Y-BOCS score measured at week 8
1169133|NCT00389493|O3|Outcome|Treatment With Pill Placebo|"Participants received treatment with the placebo~Placebo : Placebo capsules will be identical in appearance to those of risperidone.~Mean Y-BOCS score measured at week 8"
1169134|NCT00389493|O2|Outcome|Treatment With Exposure/Response Prevention|"Participants received exposure and response prevention therapy~Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.~Mean Y-BOCS score measured at week 8"
1169135|NCT00389493|O1|Outcome|Treatment With Risperidone|Participants received treatment with risperidone Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated Mean Y-BOCS score measured at week 8
1169136|NCT00389493|O3|Outcome|Treatment With Pill Placebo|"Participants received treatment with the placebo~Placebo : Placebo capsules will be identical in appearance to those of risperidone.~Mean Y-BOCS score measured at week 8"
1169137|NCT00389493|O2|Outcome|Treatment With Exposure/Response Prevention|"Participants received exposure and response prevention therapy~Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.~Mean Y-BOCS score measured at week 8"
1169138|NCT00389493|O1|Outcome|Treatment With Risperidone|Participants received treatment with risperidone Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated Mean Y-BOCS score measured at week 8
1169139|NCT00389493|E3|Reported Event|Treatment With Pill Placebo|"Participants received treatment with the placebo~Placebo : Placebo capsules will be identical in appearance to those of risperidone.~Mean Y-BOCS score measured at week 8"
1169237|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
1169238|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169140|NCT00389493|E2|Reported Event|Treatment With Exposure/Response Prevention|"Participants received exposure and response prevention therapy~Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.~Mean Y-BOCS score measured at week 8"
1169141|NCT00389493|E1|Reported Event|Treatment With Risperidone|Participants received treatment with risperidone Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated Mean Y-BOCS score measured at week 8
1169142|NCT00389467|B5|Baseline|Total|Total of all reporting groups
1169143|NCT00389467|B4|Baseline|Standard Care, Nonpenumbral|Treatment assignment = standard medical care, imaging pattern = nonpenumbral
1169144|NCT00389467|B3|Baseline|Embolectomy, Nonpenumbral|Treatment assignment = embolectomy, imaging pattern = nonpenumbral
1169145|NCT00389467|B2|Baseline|Standard Care, Penumbral|Treatment assignment = standard medical care, imaging pattern = penumbral
1169146|NCT00389467|B1|Baseline|Embolectomy, Penumbral|Treatment assignment = embolectomy, imaging pattern = penumbral
1169147|NCT00389467|P4|Participant Flow|Standard Care, Nonpenumbral|"Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.~Intra-arterial tPA up to 14 milligrams was allowed as rescue therapy within 6 hours of onset."
1169148|NCT00389467|P3|Participant Flow|Embolectomy, Nonpenumbral|"Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.~Intra-arterial tPA up to 14 milligrams was allowed as rescue therapy within 6 hours of onset."
1169201|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
1169202|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
1169203|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169149|NCT00389467|P2|Participant Flow|Standard Care, Penumbral|"Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.~Intra-arterial tPA up to 14 milligrams was allowed as rescue therapy within 6 hours of onset."
1169150|NCT00389467|P1|Participant Flow|Embolectomy, Penumbral|"Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.~Intra-arterial tPA up to 14 milligrams was allowed as rescue therapy within 6 hours of onset."
1169151|NCT00389467|O4|Outcome|Standard Care, Nonpenumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
1169152|NCT00389467|O3|Outcome|Embolectomy, Nonpenumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
1169153|NCT00389467|O2|Outcome|Standard Care, Penumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
1169154|NCT00389467|O1|Outcome|Embolectomy, Penumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
1169155|NCT00389467|O4|Outcome|Standard Care, Nonpenumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
1169156|NCT00389467|O3|Outcome|Embolectomy, Nonpenumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
1169157|NCT00389467|O2|Outcome|Standard Care, Penumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
1169158|NCT00389467|O1|Outcome|Embolectomy, Penumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
1169239|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
1169240|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
1169986|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169159|NCT00389467|O4|Outcome|Standard Care, Nonpenumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
1169160|NCT00389467|O3|Outcome|Embolectomy, Nonpenumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
1169161|NCT00389467|O2|Outcome|Standard Care, Penumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
1169162|NCT00389467|O1|Outcome|Embolectomy, Penumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
1169163|NCT00389467|E5|Reported Event|Standard Care, Nonpenumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
1169164|NCT00389467|E4|Reported Event|Embolectomy, Nonpenumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
1169165|NCT00389467|E3|Reported Event|Standard Care, Penumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
1169204|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
1169923|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169166|NCT00389467|E2|Reported Event|Embolectomy, Penumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
1169167|NCT00389467|E1|Reported Event|Total Cohort|
1169168|NCT00389441|B1|Baseline|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
1169169|NCT00389441|P1|Participant Flow|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
1169170|NCT00389441|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
1169171|NCT00389441|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
1169172|NCT00389441|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
1169173|NCT00389441|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
1169174|NCT00389441|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
1169175|NCT00389441|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
1169176|NCT00389441|E1|Reported Event|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
1169177|NCT00389324|B1|Baseline|Safety Population|The safety population included all subjects who received any amount of study medication (IGIV-C) via intravenous (IV) and/or subcutaneous (SC) routes of administration. As such, the safety population included all study participants combined (who received any dose), whether they entered the study in the Run-In or Intravenous Phase.
1169241|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
1169242|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169243|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
1169178|NCT00389324|P1|Participant Flow|IGIV-C|"21 subjects were required to enter a Run-In Phase (3 to 4 months) and received IGIV-C between 200 and 600 mg/kg by intravenous infusion every 3 or 4 weeks. 18 subjects completed the Run-In Phase and entered the Intravenous Phase.~A total of 32 subjects entered the IV Phase: 14 subjects who had received IV IGIV-C prior to screening directly entered the IV Phase and 18 subjects who had completed the Run-in Phase continued in the study to enter the IV Phase. Subjects in the IV Phase received two IV infusions at the same dose (200-600 mg/kg) and frequency (every 3 or 4 weeks) as their regular dose at screening or during the Run-In Phase. All 32 subjects completed the IV Phase and entered the SC Phase.~A total of 32 subjects who completed the IV Phase entered the SC Phase. Subjects in the SC Phase received IGIV-C via weekly SC administration for 24 weeks total at a dose that was calculated using a conversion factor and their established IV dose. 25 subjects completed the SC Phase."
1169179|NCT00389324|O2|Outcome|Gamunex Subcutaneous (SC) Administration|Subjects who received Gamunex via SC administration.
1169180|NCT00389324|O1|Outcome|Gamunex Intravenous (IV) Administration|Subjects who received Gamunex via IV administration.
1169181|NCT00389324|E3|Reported Event|Subcutaneous Phase|All subjects who participated in the Subcutaneous Phase.
1169182|NCT00389324|E2|Reported Event|Intravenous Phase|All subjects who participated in the Intravenous Phase.
1169183|NCT00389324|E1|Reported Event|Run-In Phase|All subjects who participated in the Run-In Phase.
1169184|NCT00389207|B4|Baseline|Total|Total of all reporting groups
1169185|NCT00389207|B3|Baseline|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169186|NCT00389207|B2|Baseline|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
1169187|NCT00389207|B1|Baseline|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
1169188|NCT00389207|P3|Participant Flow|Atazanvir/Ritonavir|Atazanvir 300mg QD boosted by ritonavir 100mg QD (ATZ/r) on a background of the fixed combination Truvada®
1169189|NCT00389207|P2|Participant Flow|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
1169190|NCT00389207|P1|Participant Flow|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
1169191|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169192|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
1169193|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
1169194|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169195|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
1169196|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
1169197|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169208|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
1169209|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169210|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
1169211|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
1169212|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169213|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
1169214|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
1169215|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169216|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
1169217|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
1169218|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169219|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
1169220|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
1169221|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
1169222|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169223|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
1169224|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
1169225|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
1169226|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169227|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
1169228|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
1169229|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
1169230|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169231|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
1169232|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
1169233|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
1169234|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169235|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
1169236|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
1169244|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
1169245|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
1169246|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169247|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
1169248|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
1169249|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
1169250|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169251|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
1169252|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
1169253|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
1169254|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169255|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
1169256|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169257|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
1169258|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169259|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
1169260|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169261|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
1169263|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
1169264|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169265|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
1169266|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169267|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
1169268|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169269|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
1169270|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169271|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
1169272|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169273|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
1169274|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169275|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
1169276|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169277|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
1169278|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169279|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
1169280|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169281|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
1169282|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169283|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
1169284|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169285|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
1169286|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
1169287|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
1169288|NCT00389207|E3|Reported Event|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
1169289|NCT00389207|E2|Reported Event|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
1169290|NCT00389207|E1|Reported Event|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
1169291|NCT00389168|B3|Baseline|Total|Total of all reporting groups
1169292|NCT00389168|B2|Baseline|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
1169293|NCT00389168|B1|Baseline|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
1169294|NCT00389168|P2|Participant Flow|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of hydrochlorothiazide (HCTZ) and felodipine when needed to achieve < 140/90 mm Hg
1169295|NCT00389168|P1|Participant Flow|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of hydrochlorothiazide (HCTZ) and felodipine when needed to achieve < 140/90 mm Hg
1169296|NCT00389168|O2|Outcome|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
1169297|NCT00389168|O1|Outcome|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
1169298|NCT00389168|O2|Outcome|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
1169299|NCT00389168|O1|Outcome|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
1169300|NCT00389168|O2|Outcome|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
1169301|NCT00389168|O1|Outcome|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
1169302|NCT00389168|O2|Outcome|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
1169303|NCT00389168|O1|Outcome|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
1169304|NCT00389168|O2|Outcome|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
1169305|NCT00389168|O1|Outcome|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
1169306|NCT00389168|O2|Outcome|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
1169307|NCT00389168|O1|Outcome|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
1169308|NCT00389168|E2|Reported Event|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
1169924|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169309|NCT00389168|E1|Reported Event|Irbesratan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
1169310|NCT00389064|B3|Baseline|Total|Total of all reporting groups
1169311|NCT00389064|B2|Baseline|Placebo|
1169312|NCT00389064|B1|Baseline|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
1169313|NCT00389064|P2|Participant Flow|Placebo|
1169314|NCT00389064|P1|Participant Flow|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
1169315|NCT00389064|O2|Outcome|Placebo|
1169316|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
1169317|NCT00389064|O2|Outcome|Placebo|
1169318|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
1169319|NCT00389064|O2|Outcome|Placebo|
1169320|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
1169321|NCT00389064|O2|Outcome|Placebo|
1169322|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
1169323|NCT00389064|O2|Outcome|Placebo|
1169324|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
1169325|NCT00389064|O2|Outcome|Placebo|
1169326|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
1169327|NCT00389064|O2|Outcome|Placebo|
1169328|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
1169329|NCT00389064|O2|Outcome|Placebo|
1169330|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
1169331|NCT00389064|O2|Outcome|Placebo|
1169332|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
1169333|NCT00389064|O2|Outcome|Placebo|
1169334|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
1169335|NCT00389064|O2|Outcome|Placebo|
1169336|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
1169337|NCT00389064|E2|Reported Event|Placebo|
1169338|NCT00389064|E1|Reported Event|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
1169339|NCT00388973|B3|Baseline|Total|Total of all reporting groups
1169340|NCT00388973|B2|Baseline|Placebo|Placebo
1169341|NCT00388973|B1|Baseline|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
1169342|NCT00388973|P2|Participant Flow|Placebo|Placebo
1169343|NCT00388973|P1|Participant Flow|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
1169344|NCT00388973|O2|Outcome|Placebo|Placebo
1169345|NCT00388973|O1|Outcome|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
1169346|NCT00388973|O2|Outcome|Placebo|Placebo
1169347|NCT00388973|O1|Outcome|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
1169348|NCT00388973|O2|Outcome|Placebo|Placebo
1169349|NCT00388973|O1|Outcome|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
1169350|NCT00388973|O2|Outcome|Placebo|Placebo
1169351|NCT00388973|O1|Outcome|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
1169352|NCT00388973|O2|Outcome|Placebo|Placebo
1169353|NCT00388973|O1|Outcome|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
1169354|NCT00388973|O2|Outcome|Placebo|Placebo
1169355|NCT00388973|O1|Outcome|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
1169356|NCT00388973|O2|Outcome|Placebo|Placebo
1169357|NCT00388973|O1|Outcome|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
1169358|NCT00388973|O2|Outcome|Placebo|Placebo
1169359|NCT00388973|O1|Outcome|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
1169360|NCT00388973|E2|Reported Event|Placebo|Placebo
1169361|NCT00388973|E1|Reported Event|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
1169362|NCT00388947|B1|Baseline|1 - Any AMS Prolapse Product|at least one AMS prolapse product was used
1169363|NCT00388947|P1|Participant Flow|1 - Any AMS Prolapse Product|at least one AMS prolapse product was used
1169364|NCT00388947|O1|Outcome|1 - Any AMS Prolapse Product|at least one AMS prolapse product was used
1169365|NCT00388947|O1|Outcome|1 - Any AMS Prolapse Product|at least one AMS prolapse product was used
1169366|NCT00388947|E1|Reported Event|1 - Any AMS Prolapse Product|at least one AMS prolapse product was used
1169367|NCT00388804|B3|Baseline|Total|Total of all reporting groups
1169368|NCT00388804|B2|Baseline|RT Group 2 + Hormone Therapy|Radiation Therapy over 8 1/2 weeks; + Hormone Therapy (Bicalutamide 50 mg orally/day or Flutamide 250 mg orally 3 times daily on first 21-30 Days) + Leuprolide (22.5 mg Intramuscularly (IM)/every 3 months or 7.5 mg IM monthly) or Goserelin (10.8 mg subcutaneously every 3 months or 3.6 mg subcutaneously monthly)
1169369|NCT00388804|B1|Baseline|RT Group 1|Radiation Therapy (RT) over 8 1/2 weeks: 42 treatments, 5 days per week with 2 days rest in between.
1169370|NCT00388804|P2|Participant Flow|RT Group 2 + Hormone Therapy|Radiation Therapy over 8 1/2 weeks; + Hormone Therapy (Bicalutamide 50 mg orally/day or Flutamide 250 mg orally 3 times daily on first 21-30 Days) + Leuprolide (22.5 mg Intramuscularly (IM)/every 3 months or 7.5 mg IM monthly) or Goserelin (10.8 mg subcutaneously every 3 months or 3.6 mg subcutaneously monthly)
1169371|NCT00388804|P1|Participant Flow|RT Group 1|Radiation Therapy (RT) over 8 1/2 weeks: 42 treatments, 5 days per week with 2 days rest in between.
1169372|NCT00388804|O2|Outcome|RT Group 2 + Hormone Therapy|Radiation Therapy over 8 1/2 weeks; + Hormone Therapy (Bicalutamide 50 mg orally/day or Flutamide 250 mg orally 3 times daily on first 21-30 Days) + Leuprolide (22.5 mg Intramuscularly (IM)/every 3 months or 7.5 mg IM monthly) or Goserelin (10.8 mg subcutaneously every 3 months or 3.6 mg subcutaneously monthly)
1169373|NCT00388804|O1|Outcome|RT Group 1|Radiation Therapy (RT) over 8 1/2 weeks: 42 treatments, 5 days per week with 2 days rest in between.
1169481|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
1169482|NCT00387881|O1|Outcome|Placebo|
1169374|NCT00388804|E2|Reported Event|RT Group 2 + Hormone Therapy|Radiation Therapy over 8 1/2 weeks; + Hormone Therapy (Bicalutamide 50 mg orally/day or Flutamide 250 mg orally 3 times daily on first 21-30 Days) + Leuprolide (22.5 mg Intramuscularly (IM)/every 3 months or 7.5 mg IM monthly) or Goserelin (10.8 mg subcutaneously every 3 months or 3.6 mg subcutaneously monthly)
1169375|NCT00388804|E1|Reported Event|RT Group 1|Radiation Therapy (RT) over 8 1/2 weeks: 42 treatments, 5 days per week with 2 days rest in between.
1169376|NCT00388726|B3|Baseline|Total|Total of all reporting groups
1169377|NCT00388726|B2|Baseline|Treatment of Physician's Choice|Treatment of Physician's Choice
1169378|NCT00388726|B1|Baseline|Eribulin Mesylate 1.4 mg/kg^2|Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
1169379|NCT00388726|P2|Participant Flow|Treatment of Physician's Choice|Treatment of Physician's Choice
1169380|NCT00388726|P1|Participant Flow|Eribulin Mesylate 1.4 mg/kg^2|Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
1169381|NCT00388726|O2|Outcome|Treatment of Physician's Choice|Treatment of Physician's Choice
1169382|NCT00388726|O1|Outcome|Eribulin Mesylate 1.4 mg/kg^2|Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
1169383|NCT00388726|O2|Outcome|Treatment of Physician's Choice|Treatment of Physician's Choice
1169384|NCT00388726|O1|Outcome|Eribulin Mesylate 1.4 mg/kg^2|Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
1169385|NCT00388726|O2|Outcome|Treatment of Physician's Choice|Treatment of Physician's Choice
1169386|NCT00388726|O1|Outcome|Eribulin Mesylate 1.4 mg/kg^2|Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
1169387|NCT00388726|O2|Outcome|Treatment of Physician's Choice|Treatment of Physician's Choice
1169388|NCT00388726|O1|Outcome|Eribulin Mesylate 1.4 mg/kg^2|Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
1169389|NCT00388726|E2|Reported Event|Treatment of Physician's Choice|Treatment of Physician's Choice
1169390|NCT00388726|E1|Reported Event|Eribulin Mesylate 1.4 mg/kg^2|Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
1169391|NCT00388583|B3|Baseline|Total|Total of all reporting groups
1169392|NCT00388583|B2|Baseline|Fluzone IM Vaccine Group|Participants received a dose (0.5 mL) of Fluzone intramuscular vaccine on Day 0.
1169393|NCT00388583|B1|Baseline|Fluzone ID Vaccine Group|Participants received a dose (0.1 mL) of Fluzone intradermal vaccine on Day 0.
1169394|NCT00388583|P2|Participant Flow|Fluzone Intramuscular (IM) Vaccine Group|Participants received a dose of Fluzone Intramuscular vaccine on Day 0
1169395|NCT00388583|P1|Participant Flow|Fluzone Intradermal (ID) Vaccine Group|Participants received a dose of Fluzone Intradermal vaccine on Day 0
1169396|NCT00388583|O2|Outcome|Fluzone Intramuscular (IM) Vaccine Group|Participants received a dose of Fluzone Intramuscular vaccine on Day 0
1169397|NCT00388583|O1|Outcome|Fluzone Intradermal (ID) Vaccine Group|Participants received a dose of Fluzone Intradermal vaccine on Day 0
1169398|NCT00388583|O2|Outcome|Fluzone Intramuscular (IM) Vaccine Group|Participants received a dose of Fluzone Intramuscular vaccine on Day 0
1169399|NCT00388583|O1|Outcome|Fluzone Intradermal (ID) Vaccine Group|Participants received a dose of Fluzone Intradermal vaccine on Day 0
1169400|NCT00388583|O2|Outcome|Fluzone Intramuscular (IM) Vaccine Group|Participants received a dose of Fluzone Intramuscular vaccine on Day 0
1169401|NCT00388583|O1|Outcome|Fluzone Intradermal (ID) Vaccine Group|Participants received a dose of Fluzone Intradermal vaccine on Day 0
1169402|NCT00388583|O2|Outcome|Fluzone Intramuscular (IM) Vaccine Group|Participants received a dose of Fluzone Intramuscular vaccine on Day 0
1169403|NCT00388583|O1|Outcome|Fluzone Intradermal (ID) Vaccine Group|Participants received a dose of Fluzone Intradermal vaccine on Day 0
1169404|NCT00388583|E2|Reported Event|Fluzone Intramuscular (IM) Vaccine Group|Participants received a dose of Fluzone Intramuscular vaccine on Day 0
1169405|NCT00388583|E1|Reported Event|Fluzone Intradermal (ID) Vaccine Group|Participants received a dose of Fluzone Intradermal vaccine on Day 0
1169406|NCT00388505|B3|Baseline|Total|Total of all reporting groups
1169407|NCT00388505|B2|Baseline|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
1169408|NCT00388505|B1|Baseline|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
1169409|NCT00388505|P2|Participant Flow|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
1169410|NCT00388505|P1|Participant Flow|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
1169411|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
1169412|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
1169413|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
1169414|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
1169415|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
1169483|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
1169484|NCT00387881|O1|Outcome|Placebo|
1169416|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
1169417|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
1169418|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
1169419|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
1169420|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
1169421|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
1169422|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
1169423|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
1169424|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
1169425|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
1169426|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
1169427|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
1169428|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
1169429|NCT00388505|E2|Reported Event|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
1169430|NCT00388505|E1|Reported Event|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
1169431|NCT00388362|B1|Baseline|Sirolimus|Administration of Sirolimus and Prednisone
1169432|NCT00388362|P1|Participant Flow|Sirolimus Therapy|Administration of Sirolimus and Prednisone
1169433|NCT00388362|O1|Outcome|Sirolimus Therapy|Administration of Sirolimus and Prednisone
1169434|NCT00388362|O1|Outcome|Sirolimus Therapy|Administration of Sirolimus and Prednisone
1169435|NCT00388362|E1|Reported Event|Sirolimus Therapy|Administration of Sirolimus and Prednisone
1169436|NCT00388349|B1|Baseline|Gemcitabine + High-dose Chemotherapy + PBSC Rescue|Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
1169437|NCT00388349|P2|Participant Flow|1500 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue|Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
1169438|NCT00388349|P1|Participant Flow|1250 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue|Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
1169439|NCT00388349|O1|Outcome|1250 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue|Gemcitabine 1250 mg/m2 administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
1169440|NCT00388349|O1|Outcome|Gemcitabine + High-dose Chemotherapy + PBSC Rescue|Gemcitabine (1250 or 1500 mg/m2) as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
1169441|NCT00388349|O1|Outcome|Gemcitabine + High-dose Chemotherapy + PBSC Rescue|Gemcitabine (1250 or 1500 mg/m2) as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
1169442|NCT00388349|O1|Outcome|Gemcitabine + High-dose Chemotherapy + PBSC Rescue|Gemcitabine (1250 or 1500 mg/m2) administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
1169485|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
1169443|NCT00388349|O2|Outcome|1500 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue|Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
1169444|NCT00388349|O1|Outcome|1250 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue|Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
1169445|NCT00388349|E1|Reported Event|Gemcitabine + High-dose Chemotherapy + PBSC Rescue|Gemcitabine as administered in combination with vinorelbine, and then followed by high-dose carmustine + etoposide + cyclophosphamide, then autologous peripheral blood stem cell (PBSC) rescue [aka, hematopoietic stem cell transplantation (AHCT)].
1169446|NCT00388154|B1|Baseline|Gemcitabine + Cisplatin|Gemcitabine 900 mg/m^2 and Cisplatin 30 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8.
1169447|NCT00388154|P1|Participant Flow|Gemcitabine + Cisplatin|Gemcitabine 900 mg/m^2 and Cisplatin 30 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8.
1169448|NCT00388154|O1|Outcome|Gemcitabine + Cisplatin|Gemcitabine 900 mg/m^2 and Cisplatin 30 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8.
1169449|NCT00388154|O1|Outcome|Gemcitabine + Cisplatin|Gemcitabine 900 mg/m^2 and Cisplatin 30 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8.
1169450|NCT00388154|E1|Reported Event|Gemcitabine + Cisplatin|Gemcitabine 900 mg/m^2 and Cisplatin 30 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8.
1169451|NCT00388037|B1|Baseline|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~laboratory biomarker analysis: Correlative studies"
1169452|NCT00388037|P1|Participant Flow|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~laboratory biomarker analysis: Correlative studies"
1169453|NCT00388037|O1|Outcome|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~laboratory biomarker analysis: Correlative studies"
1169454|NCT00388037|E1|Reported Event|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~laboratory biomarker analysis: Correlative studies"
1169455|NCT00387959|B1|Baseline|Unrelated Donor Umbilical Cord Transplant|Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
1169456|NCT00387959|P1|Participant Flow|Unrelated Donor Umbilical Cord Transplant|Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
1169457|NCT00387959|O1|Outcome|Unrelated Donor Umbilical Cord Transplant|Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
1169458|NCT00387959|E1|Reported Event|Unrelated Donor Umbilical Cord Transplant|Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
1169459|NCT00387894|B1|Baseline|Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28|erlotinib hydrochloride (Tarceva) self-administered in an open-label, unblinded manner to all patients enrolled in the study.
1169460|NCT00387894|P1|Participant Flow|Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28|Tarceva self-administered in an open-label, unblinded manner to all patients enrolled. During the treatment period, patients who are not receiving enzyme-inducing antiepileptic drugs (EIAED) will receive single-agent Tarceva, 150 mg/day. Patients on EIAED will receive single-agent Tarceva, 600 mg/day. Tablets should be taken at the same time each day with 200 mL of water at least 1 hour before or 2 hours after a meal. Patients who are unable to swallow tablets may dissolve the tablets in distilled water for administration. The dose of Tarceva will be escalated after 14 days from 150 to 200 mg/day or from 600 to 650 mg/day assuming no intolerable grade 2 rash, any grade 3 rash, or grade 2 diarrhea despite loperamide.
1169461|NCT00387894|O1|Outcome|Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28|erlotinib hydrochloride (Tarceva) self-administered in an open-label, unblinded manner to all patients enrolled in the study.
1169462|NCT00387894|O1|Outcome|Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28|erlotinib hydrochloride (Tarceva) self-administered in an open-label, unblinded manner to all patients enrolled in the study.
1169463|NCT00387894|E1|Reported Event|Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28|erlotinib hydrochloride (Tarceva) self-administered in an open-label, unblinded manner to all patients enrolled in the study.
1169464|NCT00387881|B3|Baseline|Total|Total of all reporting groups
1169465|NCT00387881|B2|Baseline|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet. Baseline Characteristics used the Safety Population. Not the Randomised Population
1169466|NCT00387881|B1|Baseline|Placebo|Baseline Characteristics used the Safety Population. Not the Randomised Population
1169467|NCT00387881|P2|Participant Flow|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
1169468|NCT00387881|P1|Participant Flow|Placebo|
1169469|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
1169470|NCT00387881|O1|Outcome|Placebo|
1169471|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
1169472|NCT00387881|O1|Outcome|Placebo|
1169473|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
1169474|NCT00387881|O1|Outcome|Placebo|
1169475|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
1169476|NCT00387881|O1|Outcome|Placebo|
1169477|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
1169478|NCT00387881|O1|Outcome|Placebo|
1169479|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
1169487|NCT00387881|E2|Reported Event|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
1169488|NCT00387881|E1|Reported Event|Placebo|
1169489|NCT00387829|B3|Baseline|Total|Total of all reporting groups
1169490|NCT00387829|B2|Baseline|2 - Surgery Alone|Control arm is surgery alone (no adhesion barrier)
1169491|NCT00387829|B1|Baseline|1- DuraGen Plus During Surgery|Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
1169492|NCT00387829|P2|Participant Flow|2 - Surgery Alone|Control arm is surgery alone (no adhesion barrier)
1169493|NCT00387829|P1|Participant Flow|1- DuraGen Plus During Surgery|Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
1169494|NCT00387829|O2|Outcome|2 - Surgery Alone|Control arm is surgery alone (no adhesion barrier)
1169495|NCT00387829|O1|Outcome|1- DuraGen Plus During Surgery|Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
1169496|NCT00387829|O2|Outcome|2 - Surgery Alone|Control arm is surgery alone (no adhesion barrier)
1169497|NCT00387829|O1|Outcome|1- DuraGen Plus During Surgery|Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
1169498|NCT00387829|E2|Reported Event|2 - Surgery Alone|Control arm is surgery alone (no adhesion barrier)
1169499|NCT00387829|E1|Reported Event|1- DuraGen Plus During Surgery|Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
1169500|NCT00387790|B1|Baseline|Radiation and Motexafin Gadolinium|"Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~motexafin gadolinium: Given IV~2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy: Undergo localized cranial radiotherapy"
1169501|NCT00387790|P1|Participant Flow|Radiation and Motexafin Gadolinium|"Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~motexafin gadolinium: Given IV~2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy: Undergo localized cranial radiotherapy"
1169502|NCT00387790|O1|Outcome|Radiation and Motexafin Gadolinium|"Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~motexafin gadolinium: Given IV~2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy: Undergo localized cranial radiotherapy"
1169503|NCT00387790|E1|Reported Event|Radiation and Motexafin Gadolinium|"Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~motexafin gadolinium: Given IV~2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy: Undergo localized cranial radiotherapy"
1169504|NCT00387764|B1|Baseline|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
1169505|NCT00387764|P1|Participant Flow|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
1169506|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
1169507|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
1169508|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
1169509|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
1169510|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
1169511|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
1169512|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
1169513|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
1169514|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
1169515|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
1169516|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
1169517|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
1169518|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
1169519|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
1169520|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
1169521|NCT00387764|E1|Reported Event|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
1169522|NCT00387751|B1|Baseline|Bevacizumab and Sorafenib|
1169523|NCT00387751|P1|Participant Flow|Bevacizumab and Sorafenib|
1169524|NCT00387751|O1|Outcome|Bevacizumab and Sorafenib|"Bevacizumab was administered as a 5 mg/kg intravenous dose every 2 weeks. The dose was based on the patient's actual body weight; the dose recalculated if there was a weight change of >10% from baseline.~Sorafenib was administered as a 200 mg oral dose twice daily, for 5 days every 7 days. Courses will be defined as 28-day treatment periods and will be repeated without interruption until development of progressive disease or development of serious drug related toxicities."
1169525|NCT00387751|E1|Reported Event|Bevacizumab and Sorafenib|
1169526|NCT00387725|B5|Baseline|Total|Total of all reporting groups
1169527|NCT00387725|B4|Baseline|Initial Formulation rLP2086 200 mcg|Given on a 0, 1-, 6- month schedule
1169528|NCT00387725|B3|Baseline|Initial Formulation rLP2086 60 mcg|Given on a 0, 1-, 6- month schedule
1169529|NCT00387725|B2|Baseline|Initial Formulation rLP2086 20 mcg|Given on a 0, 1-, 6- month schedule
1169530|NCT00387725|B1|Baseline|Twinrix|Given on a 0, 1-, 6- month schedule
1169531|NCT00387725|P4|Participant Flow|Initial Formulation rLP2086 200 mcg|Given on a 0, 1-, 6- month schedule
1169532|NCT00387725|P3|Participant Flow|Initial Formulation rLP2086 60 mcg|Given on a 0, 1-, 6- month schedule
1169533|NCT00387725|P2|Participant Flow|Initial Formulation rLP2086 20 mcg|Given on a 0, 1-, 6- month schedule
1169534|NCT00387725|P1|Participant Flow|Twinrix|Given on a 0, 1-, 6- month schedule
1169535|NCT00387725|O4|Outcome|Initial Formulation rLP2086 200 mcg|Given on a 0, 1-, 6- month schedule
1169536|NCT00387725|O3|Outcome|Initial Formulation rLP2086 60 mcg|Given on a 0, 1-, 6- month schedule
1169537|NCT00387725|O2|Outcome|Initial Formulation rLP2086 20 mcg|Given on a 0, 1-, 6- month schedule
1169538|NCT00387725|O1|Outcome|Twinrix|Given on a 0, 1-, 6- month schedule
1169539|NCT00387725|O4|Outcome|Initial Formulation rLP2086 200 mcg|Given on a 0, 1-, 6- month schedule
1169540|NCT00387725|O3|Outcome|Initial Formulation rLP2086 60 mcg|Given on a 0, 1-, 6- month schedule
1169541|NCT00387725|O2|Outcome|Initial Formulation rLP2086 20 mcg|Given on a 0, 1-, 6- month schedule
1169542|NCT00387725|O1|Outcome|Twinrix|Given on a 0, 1-, 6- month schedule
1169543|NCT00387725|O4|Outcome|Initial Formulation rLP2086 200 mcg|Given on a 0, 1-, 6- month schedule
1169544|NCT00387725|O3|Outcome|Initial Formulation rLP2086 60 mcg|Given on a 0, 1-, 6- month schedule
1169545|NCT00387725|O2|Outcome|Initial Formulation rLP2086 20 mcg|Given on a 0, 1-, 6- month schedule
1169546|NCT00387725|O1|Outcome|Twinrix|Given on a 0, 1-, 6- month schedule
1169547|NCT00387725|E4|Reported Event|Initial Formulation rLP2086 200 mcg|Given on a 0, 1-, 6- month schedule
1169548|NCT00387725|E3|Reported Event|Initial Formulation rLP2086 60 mcg|Given on a 0, 1-, 6- month schedule
1169549|NCT00387725|E2|Reported Event|Initial Formulation rLP2086 20 mcg|Given on a 0, 1-, 6- month schedule
1169550|NCT00387725|E1|Reported Event|Twinrix|Given on a 0, 1-, 6- month schedule
1169551|NCT00387673|B1|Baseline|Effect of Prolonged Electrical Stimulation on Neural Plastici|
1169552|NCT00387673|P3|Participant Flow|Arm 3|"a 6-week period of 2 hours sham somatosensory stimulation of the hand, followed by 1 hour of activity-based training~Somatosensory Stimulation and Massed Practice Training: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects."
1169553|NCT00387673|P2|Participant Flow|Arm 2|"a 6-week period of 2 hours somatosensory stimulation of the hand, without training~Somatosensory Stimulation and Massed Practice Training: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects."
1169576|NCT00387647|O1|Outcome|Azacitidine Treatment|Azacitidine 50 mg/m^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles. Patients were to be followed for 1 year following completion of study drug treatment.
1169577|NCT00387647|E1|Reported Event|Azacitidine Treatment|Azacitidine 50 mg/m^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles. Patients were to be followed for 1 year following completion of study drug treatment.
1169578|NCT00387621|B4|Baseline|Total|Total of all reporting groups
1169579|NCT00387621|B3|Baseline|Preclinical Diastolic Dysfunction Group (PDD)|Participants with an ejection fraction of > 50% and no heart failure symptoms
1169554|NCT00387673|P1|Participant Flow|Arm 1|"6 weeks of upper extremity training for 3 sessions/week, as follows: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session);~Somatosensory Stimulation and Massed Practice Training: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects."
1169555|NCT00387673|O3|Outcome|Arm 3|"a 6-week period of 2 hours sham somatosensory stimulation of the hand, followed by 1 hour of activity-based training~Somatosensory Stimulation and Massed Practice Training: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects."
1169556|NCT00387673|O2|Outcome|Arm 2|"a 6-week period of 2 hours somatosensory stimulation of the hand, without training~Somatosensory Stimulation and Massed Practice Training: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects."
1169594|NCT00387621|O2|Outcome|Preclinical Systolic Dysfunction Group (PSD)|Participants with ejection fraction <40% and no heart failure symptoms
1169595|NCT00387621|O1|Outcome|Control Group (Normals)|Healthy volunteers without heart disease
1169596|NCT00387621|O3|Outcome|PDD-Preclinical Diastolic Dysfunction|Participants with an ejection fraction of > 50% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
1169557|NCT00387673|O1|Outcome|Arm 1|"6 weeks of upper extremity training for 3 sessions/week, as follows: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session);~Somatosensory Stimulation and Massed Practice Training: a) somatosensory stimulation of the median, ulnar and radial nerves at the level of the wrist (2 hours/session); SS group b) somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); SS+ABT group and c) sham somatosensory stimulation of the median, ulnar and radial nerves at the wrist (2 hours/session) followed by an activity-based upper extremity training program (1 hour/session); ABT group then carry out training in the 3 subject groups simultaneously, each group consisting of 2 subjects at a time, with 2 sets of subjects/year over a 2-year period, yielding a target sample of 36 subjects."
1169558|NCT00387673|E1|Reported Event|Project Closed|
1169559|NCT00387660|B3|Baseline|Total|Total of all reporting groups
1169560|NCT00387660|B2|Baseline|Arm B|Relapsed small cell lung cancer with previous chemotherapy
1169561|NCT00387660|B1|Baseline|Arm A|Metastatic small cell lung cancer with no previous chemotherapy
1169562|NCT00387660|P2|Participant Flow|Arm B - Relapsed SCLC (Previous Chemo)|Relapsed small cell lung cancer with previous chemotherapy
1169563|NCT00387660|P1|Participant Flow|Arm A - Metastatic SCLC (no Previous Chemo)|Extensive small cell lung cancer with no previous chemotherapy
1169564|NCT00387660|O2|Outcome|Arm B|Irinotecan (150 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
1169565|NCT00387660|O1|Outcome|Arm A|Irinotecan (200 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
1169566|NCT00387660|O2|Outcome|Arm B|Irinotecan (150 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
1169567|NCT00387660|O1|Outcome|Arm A|Irinotecan (200 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
1169568|NCT00387660|O2|Outcome|Arm B|Irinotecan (150 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
1169569|NCT00387660|O1|Outcome|Arm A|Irinotecan (200 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
1169570|NCT00387660|E2|Reported Event|Arm B|Irinotecan (150 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
1169571|NCT00387660|E1|Reported Event|Arm A|Irinotecan (200 mg/m2, q21 days) for 6 cycles, Carboplatin (AUC=5mg/ml x min, q21 days) for 6 cycles
1169572|NCT00387647|B1|Baseline|Azacitidine Treatment|Azacitidine 50 mg/m^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles. Patients were to be followed for 1 year following completion of study drug treatment.
1169573|NCT00387647|P1|Participant Flow|Azacitidine Treatment|Azacitidine 50 mg/m^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles. Patients were to be followed for 1 year following completion of study drug treatment.
1169574|NCT00387647|O1|Outcome|Azacitidine Treatment|Azacitidine 50 mg/m^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles. Patients were to be followed for 1 year following completion of study drug treatment.
1169575|NCT00387647|O1|Outcome|Azacitidine Treatment|Azacitidine 50 mg/m^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles. Patients were to be followed for 1 year following completion of study drug treatment.
1169878|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
1169580|NCT00387621|B2|Baseline|Preclinical Systolic Dysfunction Group (PSD)|Participants with ejection fraction <40% and no heart failure symptoms
1169581|NCT00387621|B1|Baseline|Control Group (Normals)|Healthy volunteers without heart disease
1169582|NCT00387621|P2|Participant Flow|Nesiritide First, Then Placebo (Arm B)|In the first intervention period the subjects received subcutaneous nesiritide given in the abdomen. After a lead in period of 15 minutes, the acute saline load was administered. There was a 2 week washout period. In the second intervention period, the subjects received subcutaneous placebo given in the abdomen. After a lead in period of 15 minutes, the acute saline load was administered.
1169583|NCT00387621|P1|Participant Flow|Placebo First, Then Nesiritide (Arm A)|In the first intervention period the subjects received subcutaneous placebo given in the abdomen. After a lead in period of 15 minutes, the acute saline load was administered. There was a 2 week washout period. In the second intervention period, the subjects received subcutaneous nesiritide given in the abdomen. After a lead in period of 15 minutes, the acute saline load was administered.
1169584|NCT00387621|O3|Outcome|Preclinical Diastolic Dysfunction Group (PDD)|Participants with an ejection fraction of > 50% and no heart failure symptoms
1169585|NCT00387621|O2|Outcome|Preclinical Systolic Dysfunction Group (PSD)|Participants with ejection fraction <40% and no heart failure symptoms
1169586|NCT00387621|O1|Outcome|Control Group (Normals)|Healthy volunteers without heart disease
1169587|NCT00387621|O3|Outcome|Preclinical Diastolic Dysfunction Group (PDD)|Participants with an ejection fraction of > 50% and no heart failure symptoms
1169588|NCT00387621|O2|Outcome|Preclinical Systolic Dysfunction Group (PSD)|Participants with ejection fraction <40% and no heart failure symptoms
1169589|NCT00387621|O1|Outcome|Control Group (Normals)|Healthy volunteers without heart disease
1169590|NCT00387621|O3|Outcome|Preclinical Diastolic Dysfunction Group (PDD)|Participants with an ejection fraction of > 50% and no heart failure symptoms
1169591|NCT00387621|O2|Outcome|Preclinical Systolic Dysfunction Group (PSD)|Participants with ejection fraction <40% and no heart failure symptoms
1169592|NCT00387621|O1|Outcome|Control Group (Normals)|Healthy volunteers without heart disease
1169593|NCT00387621|O3|Outcome|Preclinical Diastolic Dysfunction Group (PDD)|Participants with an ejection fraction of > 50% and no heart failure symptoms
1169597|NCT00387621|O2|Outcome|PSD-Preclinical Systolic Dysfunction|Participants with ejection fraction <40% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
1169598|NCT00387621|O1|Outcome|Control|Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
1169599|NCT00387621|O3|Outcome|PDD-Preclinical Diastolic Dysfunction|Participants with an ejection fraction of > 50% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
1169600|NCT00387621|O2|Outcome|PSD-Preclinical Systolic Dysfunction|Participants with ejection fraction <40% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
1169601|NCT00387621|O1|Outcome|Control|Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
1169602|NCT00387621|O3|Outcome|PDD-Preclinical Diastolic Dysfunction|Participants with an ejection fraction of > 50% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
1169603|NCT00387621|O2|Outcome|PSD-Preclinical Systolic Dysfunction|Participants with ejection fraction <40% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
1169604|NCT00387621|O1|Outcome|Control|Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
1169605|NCT00387621|O3|Outcome|PDD-Preclinical Diastolic Dysfunction|Participants with an ejection fraction of > 50% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
1169606|NCT00387621|O2|Outcome|PSD-Preclinical Systolic Dysfunction|Participants with ejection fraction <40% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
1169607|NCT00387621|O1|Outcome|Control|Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
1169643|NCT00387335|O1|Outcome|Sunitinib -- Cohort A|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
1169608|NCT00387621|O1|Outcome|Control Group|Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) and Nesiritide First, then Placebo (Arm B).
1169609|NCT00387621|O1|Outcome|Control Group|Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
1169610|NCT00387621|E2|Reported Event|Nesiritide|The first 10 subjects in each group received a dose of 5 ug/kg and the next 10 subjects received a dose of 10 ug/kg. As this was a cross over study, all participants received placebo and nesiritide.
1169611|NCT00387621|E1|Reported Event|Placebo|The pharmacy created a placebo subcutaneous injection volume to match the volume of the nesiritide dose. As this was a cross over study, all participants received placebo and nesiritide.
1169612|NCT00387426|B1|Baseline|Sunitinib|37.5 mg orally daily for 6-week cycle
1169613|NCT00387426|P1|Participant Flow|Sunitinib|37.5 mg orally daily for 6-week cycle
1169614|NCT00387426|O1|Outcome|Sunitinib|37.5 mg orally daily for 6-week cycle
1169615|NCT00387426|E1|Reported Event|Sunitinib|37.5 mg orally daily for 6-week cycle
1169616|NCT00387348|B4|Baseline|Total|Total of all reporting groups
1169617|NCT00387348|B3|Baseline|Escitalopram-Placebo|Participants in this arm were randomzied to receive escitalopram for the first 4 weeks and placebo for the second 4 weeks
1169618|NCT00387348|B2|Baseline|Placebo-Escitalopram|Participants in this arm were randomized to receive placebo for the first 4 weeks and escitalopram for the second 4 weeks
1169619|NCT00387348|B1|Baseline|Placebo-Placebo|Participants in this arm were randomized to receive placebo for the first 4 weeks and placebo for the second 4 weeks
1169620|NCT00387348|P3|Participant Flow|Escitalopram-Placebo|Participants in this arm were randomzied to receive escitalopram 10 mg once daily by mouth for the first 4 weeks and placebo once daily by mouth for the second 4 weeks
1169621|NCT00387348|P2|Participant Flow|Placebo-Escitalopram|Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and escitalopram 10 mg once daily by mouth for the second 4 weeks
1169910|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169622|NCT00387348|P1|Participant Flow|Placebo-Placebo|Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and placebo once daily by mouth for the second 4 weeks.
1169623|NCT00387348|O3|Outcome|Escitalopram-Placebo|Participants in this arm were randomzied to receive escitalopram 10 mg once daily by mouth for the first 4 weeks and placebo once daily by mouth for the second 4 weeks
1169624|NCT00387348|O2|Outcome|Placebo-Escitalopram|Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and escitalopram 10 mg once daily by mouth for the second 4 weeks
1169625|NCT00387348|O1|Outcome|Placebo-Placebo|Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and placebo once daily by mouth for the second 4 weeks
1169626|NCT00387348|O3|Outcome|Escitalopram-Placebo|Participants in this arm were randomzied to receive escitalopram for the first 4 weeks and placebo for the second 4 weeks
1169627|NCT00387348|O2|Outcome|Placebo-Escitalopram|Participants in this arm were randomized to receive placebo for the first 4 weeks and escitalopram for the second 4 weeks
1169628|NCT00387348|O1|Outcome|Placebo-Placebo|Participants in this arm were randomized to receive placebo for the first 4 weeks and placebo for the second 4 weeks
1169629|NCT00387348|O3|Outcome|Escitalopram-Placebo|Participants in this arm were randomzied to receive escitalopram f10 mg once daily by mouth or the first 4 weeks and placebo once daily by mouth for the second 4 weeks
1169630|NCT00387348|O2|Outcome|Placebo-Escitalopram|Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and escitalopram 10 mg once daily by mouth for the second 4 weeks
1169631|NCT00387348|O1|Outcome|Placebo-Placebo|Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and placebo oncedaily by mouth for the second 4 weeks
1169632|NCT00387348|E3|Reported Event|Escitalopram-Placebo|Participants in this arm were randomzied to receive escitalopram for the first 4 weeks and placebo for the second 4 weeks
1169633|NCT00387348|E2|Reported Event|Placebo-Escitalopram|Participants in this arm were randomized to receive placebo for the first 4 weeks and escitalopram for the second 4 weeks
1169634|NCT00387348|E1|Reported Event|Placebo-Placebo|Participants in this arm were randomized to receive placebo for the first 4 weeks and placebo for the second 4 weeks
1169635|NCT00387335|B3|Baseline|Total|Total of all reporting groups
1169636|NCT00387335|B2|Baseline|Sunitinib -- Cohort B|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 2.
1169637|NCT00387335|B1|Baseline|Sunitinib -- Cohort A|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 0 -1.
1169638|NCT00387335|P2|Participant Flow|Sunitinib -- Cohort B|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.ECOG Performance Status 2.
1169639|NCT00387335|P1|Participant Flow|Sunitinib -- Cohort A|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 0 -1.
1169640|NCT00387335|O2|Outcome|Sunitinib -- Cohort B|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
1169641|NCT00387335|O1|Outcome|Sunitinib -- Cohort A|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
1169642|NCT00387335|O2|Outcome|Sunitinib -- Cohort B|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
1169879|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
1169644|NCT00387335|O2|Outcome|Sunitinib -- Cohort B|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
1169645|NCT00387335|O1|Outcome|Sunitinib -- Cohort A|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
1169646|NCT00387335|O2|Outcome|Sunitinib -- Cohort B|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
1169647|NCT00387335|O1|Outcome|Sunitinib -- Cohort A|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
1169648|NCT00387335|E2|Reported Event|Sunitinib -- Cohort B|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 2.
1169649|NCT00387335|E1|Reported Event|Sunitinib -- Cohort A|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 0 -1.
1169650|NCT00387153|B1|Baseline|MPC-2130 Group 1|Group 1 will be dosed at 10 mg/ml administered via IV over a 1-2 hour period.
1169651|NCT00387153|P1|Participant Flow|MPC-2130 Group 1|Group 1 will be dosed at 10 mg/ml administered via IV over a 1-2 hour period.
1169652|NCT00387153|O1|Outcome|MPC-2130 Group 1|Group 1 will be dosed at 10 mg/ml administered via IV over a 1-2 hour period.
1169653|NCT00387153|E1|Reported Event|MPC-2130 Group 1|Group 1 will be dosed at 10 mg/ml administered via IV over a 1-2 hour period.
1169654|NCT00387127|B3|Baseline|Total|Total of all reporting groups
1169655|NCT00387127|B2|Baseline|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
1169656|NCT00387127|B1|Baseline|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
1169657|NCT00387127|P2|Participant Flow|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
1169658|NCT00387127|P1|Participant Flow|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
1169659|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
1169660|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
1169661|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
1169715|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169662|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
1169663|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
1169664|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
1169665|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
1169666|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
1169667|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
1169668|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
1169669|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
1169670|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
1169671|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
1169672|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
1169673|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
1169674|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
1169675|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
1169676|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
1169677|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
1169678|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
1169679|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
1169680|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
1169681|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
1169682|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
1169683|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
1169684|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
1169685|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
1169686|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
1169687|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
1169688|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
1169689|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
1169690|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
1169691|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
1169692|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
1169693|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction &lt;2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
1169694|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
1169695|NCT00387127|E2|Reported Event|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction less than 2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
1169696|NCT00387127|E1|Reported Event|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction less than 2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
1169697|NCT00387088|B3|Baseline|Total|Total of all reporting groups
1169698|NCT00387088|B2|Baseline|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169699|NCT00387088|B1|Baseline|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169700|NCT00387088|P2|Participant Flow|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169701|NCT00387088|P1|Participant Flow|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169702|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169703|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169704|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169705|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169706|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169707|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169708|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169709|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169710|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169711|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169712|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169713|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169714|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169874|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
1169716|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169717|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169718|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169719|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169720|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169721|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169722|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169723|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169724|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169725|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169726|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169727|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169728|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169729|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169911|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169730|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169731|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169732|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169733|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169734|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169735|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169736|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169737|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169738|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169739|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169740|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169741|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169742|NCT00387088|E2|Reported Event|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169743|NCT00387088|E1|Reported Event|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
1169744|NCT00387036|B1|Baseline|Entire Study Population|
1169745|NCT00387036|P2|Participant Flow|Placebo Then Fluticasone Propionate|Following 1 week Placebo run-in period (Period I), patients were randomized to receive placebo 2 inhalations twice daily for a 2-week period (Period II) followed by 2-week washout period (Period III) and 2-week fluticasone propionate 250 mcg HFA 2 inhalations twice daily (Period IV).
1169746|NCT00387036|P1|Participant Flow|Fluticasone Propionate Then Placebo|Following 1 week Placebo run-in period (Period I), patients were randomized to receive fluticasone propionate 250 mcg Hydrofluoroalkane (HFA) 2 inhalations twice daily for a 2-week period (Period II) followed by 2-week washout period (Period III) and 2-week placebo 2 inhalations twice daily (Period IV).
1169747|NCT00387036|O2|Outcome|Placebo|Placebo administered 2 inhalations twice daily in first or second intervention
1169748|NCT00387036|O1|Outcome|Fluticasone Propionate|Fluticasone Propionate 250 mcg HFA (hydrofluoroalkane) administered 2 inhalations twice daily in first or second intervention
1169749|NCT00387036|O2|Outcome|Placebo|Placebo administered 2 inhalations twice daily in first or second intervention
1169750|NCT00387036|O1|Outcome|Fluticasone Propionate|Fluticasone Propionate 250 mcg HFA (hydrofluoroalkane) administered 2 inhalations twice daily in first or second intervention
1169751|NCT00387036|E2|Reported Event|Placebo|Placebo administered 2 inhalations twice daily in first or second intervention
1169875|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
1169752|NCT00387036|E1|Reported Event|Fluticasone Propionate|Fluticasone Propionate 250 mcg HFA (hydrofluoroalkane) administered 2 inhalations twice daily in first or second intervention
1169753|NCT00387023|B1|Baseline|Zevalin + Rituximab|Rituximab 250 mg/m^2 intravenous (IV) over 4-6 hours for 2 weeks, + Zevalin 5 mCi/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week.
1169754|NCT00387023|P1|Participant Flow|Zevalin + Rituximab|Rituximab 250 mg/m^2 intravenous (IV) over 4-6 hours for 2 weeks, + Zevalin 5 millicurie (mCi)/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week.
1169755|NCT00387023|O1|Outcome|Zevalin + Rituximab|Rituximab 250 mg/m^2 intravenous (IV) over 4-6 hours for 2 weeks, + Zevalin 5 mCi/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week.
1169756|NCT00387023|E1|Reported Event|Zevalin + Rituximab|Rituximab 250 mg/m^2 intravenous (IV) over 4-6 hours for 2 weeks, + Zevalin 5 mCi/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week.
1169757|NCT00387010|B1|Baseline|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
1169758|NCT00387010|P1|Participant Flow|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
1169759|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
1169760|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
1169761|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
1169912|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169913|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169914|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169762|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
1169763|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
1169764|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
1169765|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
1169766|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
1169767|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
1169768|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
1169769|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
1169770|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
1169771|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
1169772|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
1169773|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
1169774|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
1169775|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
1169776|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
1169777|NCT00387010|E1|Reported Event|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
1169778|NCT00386880|B1|Baseline|Subjects With Episodic Migraine|Subjects with less than 8 distict migraine episodes per month.
1169779|NCT00386880|P2|Participant Flow|Subjects With Episodic Migraine Without Allodynia|These are the subjects with episodic migraine without allodynia.
1169780|NCT00386880|P1|Participant Flow|Subjects With Episodic Migraine With Allodynia|These are the subjects with episodic migraine with allodynia.
1169781|NCT00386880|O2|Outcome|Subjects With Episodic Migraine Without Allodynia|These are subjects with episodic migraine without allodynia
1169782|NCT00386880|O1|Outcome|Subjects With Episodic Migraine With Allodynia|These are subjects with episodic migraine with allodynia
1169783|NCT00386880|E1|Reported Event|Subjects With Episodic Migraine|
1169784|NCT00386776|B1|Baseline|Experimental|The intervention is a computer-based medical interview, which contains 232 primary questions that are asked of all respondents, and over 6000 frames (questions, explanations, suggestions, recommendations, and words of encouragement) that are available for presentation as determined by the patient's responses and the branching logic of the program.
1169785|NCT00386776|P1|Participant Flow|Computer-based Medical History|The intervention is a computer-based medical history designed for patients to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like. So far as possible, it is designed to model the comprehensive, inclusive, general medical history traditionally taken, when time permits, by a primary care doctor seeing a patient for the first time. It contains 232 primary questions asked of all patients about the presence or absence of medical problems. Of these, 215 have the preformatted mutually exclusive responses
1169786|NCT00386776|O1|Outcome|Computer-based Medical History|The intervention is a computer-based medical history designed for patients to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like. So far as possible, it is designed to model the comprehensive, inclusive, general medical history traditionally taken, when time permits, by a primary care doctor seeing a patient for the first time. It contains 232 primary questions asked of all patients about the presence or absence of medical problems. Of these, 215 have the preformatted mutually exclusive responses
1169915|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169787|NCT00386776|O1|Outcome|Computer-based Medical History|The intervention is a computer-based medical history designed for patients to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like. So far as possible, it is designed to model the comprehensive, inclusive, general medical history traditionally taken, when time permits, by a primary care doctor seeing a patient for the first time. It contains 232 primary questions asked of all patients about the presence or absence of medical problems. Of these, 215 have the preformatted mutually exclusive responses
1169788|NCT00386776|O1|Outcome|Computer-based Medical History|The intervention is a computer-based medical history designed for patients to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like. So far as possible, it is designed to model the comprehensive, inclusive, general medical history traditionally taken, when time permits, by a primary care doctor seeing a patient for the first time. It contains 232 primary questions asked of all patients about the presence or absence of medical problems. Of these, 215 have the preformatted mutually exclusive responses
1169789|NCT00386776|O1|Outcome|Computer-based Medical History|The intervention is a computer-based medical history designed for patients to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like. So far as possible, it is designed to model the comprehensive, inclusive, general medical history traditionally taken, when time permits, by a primary care doctor seeing a patient for the first time. It contains 232 primary questions asked of all patients about the presence or absence of medical problems. Of these, 215 have the preformatted mutually exclusive responses
1169790|NCT00386776|O1|Outcome|Computer-based Medical History|"The intervention is a computer-based medical history designed for patients to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like. So far as possible, it is designed to model the comprehensive, inclusive, general medical history traditionally taken, when time permits, by a primary care doctor seeing a patient for the first time. It contains 232 primary questions asked of all patients about the presence or absence of medical problems. Of these, 215 have the preformatted mutually exclusive responses Yes, No, Uncertain (Don't Know, Maybe), Don't understand, and I'd rather not answer; 10 have other sets of multiple choices, one response permitted; five have multiple choices with more than one response permitted, and two have numerical responses. There are also 6000 questions, explanations and suggestions, available for presentation dependent upon the patient's responses,"
1169791|NCT00386776|O1|Outcome|Computer-based Medical History|A computer-based medical history to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like.
1169792|NCT00386776|O1|Outcome|Computer-based Medical History|A computer-based medical history to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like.
1169793|NCT00386776|E1|Reported Event|Computer-based Medical History|"The intervention is a computer-based medical history designed for patients to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like. So far as possible, it is designed to model the comprehensive, inclusive, general medical history traditionally taken, when time permits, by a primary care doctor seeing a patient for the first time. It contains 232 primary questions asked of all patients about the presence or absence of medical problems. Of these, 215 have the preformatted mutually exclusive responses Yes, No, Uncertain (Don't Know, Maybe), Don't understand, and I'd rather not answer; 10 have other sets of multiple choices, one response permitted; five have multiple choices with more than one response permitted, and two have numerical responses. There are also 6000 questions, explanations and suggestions, available for presentation dependent upon the patient's responses,"
1169794|NCT00386607|B1|Baseline|Core Treatment|Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
1169795|NCT00386607|P2|Participant Flow|Extension Treatment|"For patients entering into extension, those previously treated with HCTZ (12.5 or 25 mg) in addition to aliskiren 300 mg/valsartan 320 mg were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 25 mg in the extension.~Those patients who had not received HCTZ during the core study were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 12.5 mg.~The HCTZ 12.5 mg dose could be increased to HCTZ 25 mg if the msSBP was ≥140 mmHg and/or the msDBP was ≥90 mmHg for 2 consecutive visits."
1169796|NCT00386607|P1|Participant Flow|Core Treatment|Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
1169797|NCT00386607|O1|Outcome|Extension Treatment|All patients receiving aliskiren / valsartan / HCTZ in extension study.
1169798|NCT00386607|O1|Outcome|Extension Treatment|All patients receiving aliskiren / valsartan / HCTZ in extension study.
1169799|NCT00386607|O1|Outcome|Core and Extension Treatment - Aliskiren/Valsartan/HCTZ|All patients receiving aliskiren / valsartan / HCTZ during either core or extension study.
1169800|NCT00386607|O1|Outcome|Extension Treatment|All patients receiving aliskiren / valsartan / HCTZ in extension study.
1169801|NCT00386607|O1|Outcome|Core Treatment|Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
1169802|NCT00386607|O1|Outcome|Core Treatment|Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
1169916|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169917|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169803|NCT00386607|O1|Outcome|Core Treatment|Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
1169804|NCT00386607|O1|Outcome|Core Treatment- Aliskiren/Valsartan & Aliskiren/Valsartan/HCTZ|Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
1169805|NCT00386607|E6|Reported Event|Core and Extension: Total|Core and Extension: Total includes all study patients, treated with Aliskiren/Valsartan or Aliskiren//valsartan/HCTZ during core or extension.
1169806|NCT00386607|E5|Reported Event|Core and Extension: Aliskiren / Valsartan / HCTZ 25 mg|Core and Extension: Aliskiren/Valsartan/HCTZ 25 mg
1169807|NCT00386607|E4|Reported Event|Core and Extension: Aliskiren / Valsartan / HCTZ 12.5 mg|Core and Extension: Aliskiren / Valsartan / HCTZ 12.5 mg
1169808|NCT00386607|E3|Reported Event|Core Period: Aliskiren / Valsartan|Core Period: Aliskiren/Valsartan
1169809|NCT00386607|E2|Reported Event|Core Period: Aliskiren 300 mg / Valsartan 320 mg Alone|Core Period: Aliskiren 300 mg /Valsartan 320 mg alone
1169810|NCT00386607|E1|Reported Event|Core Period: Aliskiren 150 mg / Valsartan 160 mg Alone|Core Period: Aliskiren 150 mg /Valsartan 160 mg alone
1169811|NCT00386477|B3|Baseline|Total|Total of all reporting groups
1169812|NCT00386477|B2|Baseline|Control|No vaginal cleansing or sham wash performed.
1169813|NCT00386477|B1|Baseline|Vag Prep|Vagina cleansed with betadine vaginal scrub sticks prior to performing cesarean
1169814|NCT00386477|P2|Participant Flow|Control|No vaginal cleansing or sham wash performed.
1169815|NCT00386477|P1|Participant Flow|Vag Prep|Vagina cleansed with betadine vaginal scrub sticks prior to performing cesarean
1169816|NCT00386477|O2|Outcome|Control|No vaginal cleansing or sham wash performed.
1169817|NCT00386477|O1|Outcome|Vag Prep|Vagina cleansed with betadine vaginal scrub sticks prior to performing cesarean
1169818|NCT00386477|E2|Reported Event|Control|No vaginal cleansing or sham wash performed.
1169819|NCT00386477|E1|Reported Event|Vag Prep|Vagina cleansed with betadine vaginal scrub sticks prior to performing cesarean
1169820|NCT00386425|B4|Baseline|Total|Total of all reporting groups
1169821|NCT00386425|B3|Baseline|Randomized Non-ITT Population|
1169822|NCT00386425|B2|Baseline|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
1169823|NCT00386425|B1|Baseline|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
1169824|NCT00386425|P3|Participant Flow|Randomized Non-ITT Population|Participants were randomized to either the Standard or Alternative Therapy and received 24 mcg/kg/hr during the first 24 hours (common therapy period); however, they did not continue on to receive the actual randomized therapy.
1169825|NCT00386425|P2|Participant Flow|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
1169826|NCT00386425|P1|Participant Flow|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
1169876|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
1169877|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
1169827|NCT00386425|O2|Outcome|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
1169828|NCT00386425|O1|Outcome|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
1169829|NCT00386425|O2|Outcome|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
1169830|NCT00386425|O1|Outcome|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
1169831|NCT00386425|O2|Outcome|Did Not Normalize Protein C|
1169832|NCT00386425|O1|Outcome|Normalized Protein C|
1169833|NCT00386425|O4|Outcome|Alternative Therapy - Moderate Deficiency|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours
1169834|NCT00386425|O3|Outcome|Alternative Therapy - Severe Deficiency|Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
1169835|NCT00386425|O2|Outcome|Standard Therapy - Moderate Deficiency|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
1169836|NCT00386425|O1|Outcome|Standard Therapy - Severe Deficiency|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
1169837|NCT00386425|O2|Outcome|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
1169838|NCT00386425|O1|Outcome|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
1169839|NCT00386425|O2|Outcome|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
1169840|NCT00386425|O1|Outcome|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
1169841|NCT00386425|O2|Outcome|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
1169842|NCT00386425|O1|Outcome|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
1169918|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169843|NCT00386425|O2|Outcome|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
1169844|NCT00386425|O1|Outcome|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
1169845|NCT00386425|O2|Outcome|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
1169846|NCT00386425|O1|Outcome|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
1169847|NCT00386425|E2|Reported Event|Alternative Therapy|Participants assigned to alternative therapy (Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours) who received any amount of study drug.
1169848|NCT00386425|E1|Reported Event|Standard Therapy|Participants assigned to standard therapy (24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours) who received any amount of study drug.
1169849|NCT00386360|B3|Baseline|Total|Total of all reporting groups
1169850|NCT00386360|B2|Baseline|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
1169851|NCT00386360|B1|Baseline|Placebo|Placebo, 1 tablet weekly on the same day
1169852|NCT00386360|P2|Participant Flow|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
1169853|NCT00386360|P1|Participant Flow|Placebo|Placebo, 1 tablet weekly on the same day
1169854|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
1169855|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
1169856|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
1169857|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
1169858|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
1169859|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
1169860|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
1169861|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
1169862|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
1169863|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
1169864|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
1169865|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
1169866|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
1169867|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
1169868|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
1169869|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
1169870|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
1169871|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
1169872|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
1169873|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
1169985|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169880|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
1169881|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
1169882|NCT00386360|E2|Reported Event|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
1169883|NCT00386360|E1|Reported Event|Placebo|Placebo, 1 tablet weekly on the same day
1169884|NCT00386334|B3|Baseline|Total|Total of all reporting groups
1169885|NCT00386334|B2|Baseline|Eszopiclone|Eszopiclone 2 mg tablets
1169886|NCT00386334|B1|Baseline|Placebo|Placebo tablets
1169887|NCT00386334|P2|Participant Flow|Eszopiclone|Eszopiclone 2 mg tablets
1169888|NCT00386334|P1|Participant Flow|Placebo|Placebo tablets
1169889|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169890|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169891|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169892|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169893|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169894|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169895|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169896|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169897|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169898|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169899|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169900|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169901|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169902|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169903|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169904|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169905|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169906|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169907|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169908|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169909|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169925|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169926|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169927|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169928|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169929|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169930|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169931|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169932|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169933|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169934|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169935|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169936|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169937|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169938|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169939|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169940|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169941|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169942|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169943|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169944|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169945|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169946|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169947|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169948|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169949|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169950|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169951|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169952|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169953|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169954|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169955|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169956|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169957|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169958|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169959|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169960|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169961|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169962|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169963|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169964|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169965|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169966|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169967|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169968|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169969|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169970|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169971|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169972|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169973|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169974|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169975|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169976|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169977|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169978|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169979|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169980|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169981|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169982|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169983|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169984|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169987|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169988|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169989|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169990|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169991|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169992|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169993|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169994|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169995|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169996|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169997|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1169998|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1169999|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1170000|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1170001|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1170002|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1170003|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1170004|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1170005|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1170006|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1170007|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1170008|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1170009|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1170010|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1170011|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1170012|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1170013|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1170014|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1170015|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1170016|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1170017|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1170018|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1170019|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1170020|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1170021|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1170022|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1170023|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1170024|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1170025|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
1170026|NCT00386334|O1|Outcome|Placebo|Placebo tablets
1170027|NCT00386334|E2|Reported Event|Eszopiclone|Eszopiclone 2 mg tablets
1170028|NCT00386334|E1|Reported Event|Placebo|Placebo tablets
1170029|NCT00386308|B3|Baseline|Total|Total of all reporting groups
1170030|NCT00386308|B2|Baseline|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
1170031|NCT00386308|B1|Baseline|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
1170032|NCT00386308|P2|Participant Flow|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
1170033|NCT00386308|P1|Participant Flow|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
1170034|NCT00386308|O2|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
1170035|NCT00386308|O1|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
1170036|NCT00386308|O2|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
1170037|NCT00386308|O1|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
1170038|NCT00386308|O2|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
1170039|NCT00386308|O1|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
1170040|NCT00386308|O2|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
1170041|NCT00386308|O1|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
1170042|NCT00386308|E2|Reported Event|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
1170043|NCT00386308|E1|Reported Event|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
1170044|NCT00386256|B5|Baseline|Total|Total of all reporting groups
1170045|NCT00386256|B4|Baseline|Telephone Inpatient|Received telephone counseling, recruited from inpatient setting
1170046|NCT00386256|B3|Baseline|Health Buddy Inpatient|Received Health Buddy, recruited from inpatient setting
1170047|NCT00386256|B2|Baseline|Telephone Outpatient|Received telephone counseling, recruited from outpatient setting
1170048|NCT00386256|B1|Baseline|Health Buddy Outpatient|Received Health Buddy, recruited from outpatient setting
1170049|NCT00386256|P4|Participant Flow|Telephone Inpatient|
1170050|NCT00386256|P3|Participant Flow|Health Buddy Inpatient|
1170051|NCT00386256|P2|Participant Flow|Telephone Outpatient|
1170052|NCT00386256|P1|Participant Flow|Health Buddy Outpatient|Health Buddy(R), Home telehealth technology : Exercise questions, educational messages, and clinical reminders have been programmed into the home telehealth technology and are administered daily via the Health Buddy(R) to evaluate the program's feasibility based on adherence rates, program completion rates, and safety.
1170053|NCT00386256|O4|Outcome|Telephone Inpatient|Received telephone counseling, recruited from inpatient setting
1170054|NCT00386256|O3|Outcome|Health Buddy Inpatient|Received Health Buddy, recruited from inpatient setting
1170055|NCT00386256|O2|Outcome|Telephone Outpatient|Received telephone counseling, recruited from outpatient setting
1170056|NCT00386256|O1|Outcome|Health Buddy Outpatient|Received Health Buddy, recruited from outpatient setting
1170057|NCT00386256|O4|Outcome|Telephone Inpatient|Received telephone counseling, recruited from inpatient setting
1170058|NCT00386256|O3|Outcome|Health Buddy Inpatient|Received Health Buddy, recruited from inpatient setting
1170059|NCT00386256|O2|Outcome|Telephone Outpatient|Received telephone counseling, recruited from outpatient setting
1170060|NCT00386256|O1|Outcome|Health Buddy Outpatient|Received Health Buddy, recruited from outpatient setting
1170061|NCT00386256|E4|Reported Event|Telephone Inpatient|Received telephone counseling, recruited from inpatient setting
1170062|NCT00386256|E3|Reported Event|Health Buddy Inpatient|Received Health Buddy, recruited from inpatient setting
1170063|NCT00386256|E2|Reported Event|Telephone Outpatient|Received telephone counseling, recruited from outpatient setting
1170064|NCT00386256|E1|Reported Event|Health Buddy Outpatient|Received Health Buddy, recruited from outpatient setting
1170065|NCT00386243|B3|Baseline|Total|Total of all reporting groups
1170066|NCT00386243|B2|Baseline|Arm 2|"Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.~Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.~Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.~Co-Analgesic Therapy"
1170067|NCT00386243|B1|Baseline|Arm 1|Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
1170068|NCT00386243|P2|Participant Flow|Stepped Care|"Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.~Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.~Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.~Co-Analgesic Therapy"
1170069|NCT00386243|P1|Participant Flow|Usual Care|Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
1170070|NCT00386243|O2|Outcome|Stepped Care|"Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.~Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.~Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.~Co-Analgesic Therapy"
1170071|NCT00386243|O1|Outcome|Usual Care|Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
1170072|NCT00386243|O2|Outcome|Stepped Care|"Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.~Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.~Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.~Co-Analgesic Therapy"
1170073|NCT00386243|O1|Outcome|Usual Care|Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
1170074|NCT00386243|E2|Reported Event|Stepped Care|"Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.~Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.~Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.~Co-Analgesic Therapy"
1170075|NCT00386243|E1|Reported Event|Usual Care|Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
1170076|NCT00386152|B4|Baseline|Total|Total of all reporting groups
1170077|NCT00386152|B3|Baseline|Darbepoetin Alfa (500 Mcg)|darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
1170078|NCT00386152|B2|Baseline|Epoetin Alfa (120,000 Units)|epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
1170079|NCT00386152|B1|Baseline|Epoetin Alfa (80,000 Units)|epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
1170080|NCT00386152|P3|Participant Flow|Darbepoetin Alfa (500 Mcg)|darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
1170081|NCT00386152|P2|Participant Flow|Epoetin Alfa (120,000 Units)|epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
1170082|NCT00386152|P1|Participant Flow|Epoetin Alfa (80,000 Units)|epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
1170083|NCT00386152|O3|Outcome|Darbepoetin Alfa (500 Mcg)|darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
1170084|NCT00386152|O2|Outcome|Epoetin Alfa (120,000 Units)|epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
1170085|NCT00386152|O1|Outcome|Epoetin Alfa (80,000 Units)|epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
1170086|NCT00386152|O3|Outcome|Darbepoetin Alfa (500 Mcg)|darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
1170087|NCT00386152|O2|Outcome|Epoetin Alfa (120,000 Units)|epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
1170088|NCT00386152|O1|Outcome|Epoetin Alfa (80,000 Units)|epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
1170089|NCT00386152|O3|Outcome|Darbepoetin Alfa (500 Mcg)|darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
1170090|NCT00386152|O2|Outcome|Epoetin Alfa (120,000 Units)|epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
1170091|NCT00386152|O1|Outcome|Epoetin Alfa (80,000 Units)|epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
1170092|NCT00386152|O3|Outcome|Darbepoetin Alfa (500 Mcg)|darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
1170093|NCT00386152|O2|Outcome|Epoetin Alfa (120,000 Units)|epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
1170094|NCT00386152|O1|Outcome|Epoetin Alfa (80,000 Units)|epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
1170095|NCT00386152|E3|Reported Event|Darbepoetin Alfa (500 Mcg)|darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
1170096|NCT00386152|E2|Reported Event|Epoetin Alfa (120,000 Units)|epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
1170097|NCT00386152|E1|Reported Event|Epoetin Alfa (80,000 Units)|epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
1170098|NCT00386100|B3|Baseline|Total|Total of all reporting groups
1170099|NCT00386100|B2|Baseline|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
1170100|NCT00386100|B1|Baseline|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
1170101|NCT00386100|P2|Participant Flow|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
1170102|NCT00386100|P1|Participant Flow|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
1170103|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
1170104|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
1170105|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
1170106|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
1170107|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
1170108|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
1170109|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
1170110|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
1170111|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
1170112|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
1170113|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
1170114|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
1170115|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
1170116|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
1170117|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
1170118|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
1170119|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
1170120|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
1170121|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
1170122|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
1170123|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
1170124|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
1171662|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
1170125|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
1170126|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
1170127|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
1170128|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
1170129|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
1170130|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
1170131|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
1170132|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
1170133|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
1170134|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
1170135|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
1170136|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
1170137|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
1170138|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
1170139|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
1170140|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
1170141|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
1170142|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
1170143|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
1170144|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
1170145|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
1170146|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
1170147|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
1170148|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
1170149|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
1170150|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
1170151|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
1170152|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
1170153|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
1170154|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
1170155|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
1170156|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
1170157|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
1170158|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
1170159|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
1170160|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
1170161|NCT00386100|E2|Reported Event|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
1170162|NCT00386100|E1|Reported Event|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
1170163|NCT00386022|B3|Baseline|Total|Total of all reporting groups
1170164|NCT00386022|B2|Baseline|Older PMW|"Postmenopausal women (PMW) 70-80 years old receiving the following series of treatments:~A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.~GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr~Participants studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2)"
1170208|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
1170209|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
1171663|NCT00382993|O1|Outcome|Placebo|
1170165|NCT00386022|B1|Baseline|Younger PMW|"Postmenopausal women (PMW) 45-55 years old receiving the following series of treatments:~A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.~GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr~Participants studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2)"
1170166|NCT00386022|P2|Participant Flow|Older PMW|"Postmenopausal women (PMW) 70-80 years old receiving the following series of treatments:~A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.~GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr~Participants studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2)"
1170167|NCT00386022|P1|Participant Flow|Younger PMW|"Postmenopausal women (PMW) 45-55 years old receiving the following series of treatments:~A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.~GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr~Participants studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2)"
1170168|NCT00386022|O2|Outcome|Older Postmenopausal Women|"Postmenopausal women aged 70-80 years studied after 1 month of transdermal estrogen 0.05 mg/day using the following interventions:~A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.~GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr"
1170169|NCT00386022|O1|Outcome|Young Postmenopausal Women|"Postmenopausal women aged 45-55 years studied after 1 month of transdermal estrogen 0.05 mg/day using the following interventions:~A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.~GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr"
1170170|NCT00386022|O2|Outcome|Older PMW|"Postmenopausal women aged 70-80 years studied at baseline using the following interventions:~A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.~GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr"
1170171|NCT00386022|O1|Outcome|Younger PMW|"Postmenopausal women aged 45-55 years studied at baseline using the following interventions:~A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.~GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr"
1170226|NCT00385944|O1|Outcome|Intent-to-treat Population|Both clopidogrel and prasugrel combined population
1170227|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
1170172|NCT00386022|E2|Reported Event|Older PMW|"Postmenopausal women aged 70-80 years studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2) using the following interventions:~A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.~GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr"
1170173|NCT00386022|E1|Reported Event|Younger PMW|"Postmenopausal women aged 45-55 years studied at baseline (period 1) and after 1 month of transdermal estrogen 0.05 mg/day (period 2) using the following interventions:~A single subcutaneous injection of the NAL-GLU GnRH antagonist at a dose of 150 mcg/kg.~GnRH doses of 25, 75, 250 and 750 ng/kg given IV every 4 hr"
1170174|NCT00386009|B3|Baseline|Total|Total of all reporting groups
1170175|NCT00386009|B2|Baseline|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
1170176|NCT00386009|B1|Baseline|Placebo|placebo tablet taken by mouth once a day for 12 weeks
1170177|NCT00386009|P2|Participant Flow|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
1170178|NCT00386009|P1|Participant Flow|Placebo|placebo tablet taken by mouth once a day for 12 weeks
1170179|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
1170180|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
1170181|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
1170182|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
1170183|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
1170184|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
1170185|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
1170186|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
1170187|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
1170188|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
1170189|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
1170190|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
1170191|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
1170192|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
1170193|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
1170194|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
1170195|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
1170196|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
1170197|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
1170198|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
1170199|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
1170200|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
1170201|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
1170202|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
1170203|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
1170204|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
1170205|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
1170206|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
1170207|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
1170210|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
1170211|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
1170212|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
1170213|NCT00386009|E2|Reported Event|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
1170214|NCT00386009|E1|Reported Event|Placebo|placebo tablet taken by mouth once a day for 12 weeks
1170215|NCT00385996|B1|Baseline|Erlotinib|Erlotinib 150 mg po daily
1170216|NCT00385996|P1|Participant Flow|Erlotinib|Erlotinib 150 mg po daily.
1170217|NCT00385996|O1|Outcome|Erlotinib|Erlotinib 150 mg po daily
1170218|NCT00385996|O1|Outcome|Erlotinib|Erlotinib 150 mg po daily
1170219|NCT00385996|E1|Reported Event|Erlotinib|Erlotinib 150 mg po daily.
1170220|NCT00385944|B3|Baseline|Total|Total of all reporting groups
1170221|NCT00385944|B2|Baseline|Clopidogrel/Prasugrel|One time oral loading dose (LD) of 900-mg clopidogrel (a single or cumulative dose) followed by a once daily MD of clopidogrel 150 mg and 100 mg aspirin, for 14 days. Patients cross-over to a daily MD of prasugrel 10 mg and 100 mg aspirin for an additional 14 days.
1170222|NCT00385944|B1|Baseline|Prasugrel/Clopidogrel|One time oral loading dose (LD) of 900-mg clopidogrel (a single or cumulative dose) followed by a once daily MD of prasugrel 10 mg and 100 mg aspirin, for 14 days. Patients cross-over to a daily MD of clopidogrel 150 mg and 100 mg aspirin for an additional 14 days.
1170223|NCT00385944|P3|Participant Flow|Loading Dose|Clopidogrel 900-mg Loading Dose (a single or cumulative dose)
1170224|NCT00385944|P2|Participant Flow|Clopidogrel/Prasugrel|One time oral loading dose (LD) of 900-mg clopidogrel (a single or cumulative dose)followed by a once daily MD of clopidogrel 150 mg and 100 mg aspirin, for 14 days. Patients cross-over to a daily MD of prasugrel 10 mg and 100 mg aspirin for an additional 14 days.
1170225|NCT00385944|P1|Participant Flow|Prasugrel/Clopidogrel|One time oral loading dose (LD) of 900-mg clopidogrel (a single or cumulative dose)followed by a once daily MD of prasugrel 10 mg and 100 mg aspirin, for 14 days. Patients cross-over to a daily MD of clopidogrel 150 mg and 100 mg aspirin for an additional 14 days.
1170228|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
1170229|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
1170230|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
1170231|NCT00385944|O2|Outcome|Clopidogrel/Prasugrel|Clopidogrel (150-mg MD) or Prasugrel (10-mg MD) + Aspirin (≤100-mg MD)
1170232|NCT00385944|O1|Outcome|Prasugrel/Clopidogrel|Prasugrel (10-mg MD) or Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD)
1170233|NCT00385944|O2|Outcome|Clopidogrel/Prasugrel|Clopidogrel (150-mg MD) or Prasugrel (10-mg MD) + Aspirin (≤100-mg MD)
1170234|NCT00385944|O1|Outcome|Prasugrel/Clopidogrel|Prasugrel (10-mg MD) or Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD)
1170235|NCT00385944|O2|Outcome|Clopidogrel/Prasugrel|Clopidogrel (150-mg MD)or Prasugrel (10-mg MD) + Aspirin (≤100-mg MD)
1170236|NCT00385944|O1|Outcome|Prasugrel/Clopidgrel|Prasugrel (10-mg MD) or Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD)
1170237|NCT00385944|O1|Outcome|Clopidogrel 900 mg|Clopidogrel 900 mg LD (a single or cumulative dose)
1170238|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
1170239|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
1170240|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
1170241|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
1170242|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
1170243|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
1170244|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
1170245|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
1170246|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
1170247|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
1170248|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
1170249|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
1170250|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
1170251|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
1170252|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
1170253|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
1170352|NCT00385801|E2|Reported Event|Risperidone Consta|Risperidone 1-2 mg tablets and Risperidone 25 mg injections
1170254|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
1170255|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
1170256|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
1170257|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
1170258|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
1170259|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
1170260|NCT00385944|E5|Reported Event|Prasugrel 10 mg - Crossover From Clopidogrel 150 mg|Once daily MD of prasugrel 10 mg and 100 mg aspirin, for an additional 14 days. These are patients who received a daily MD of clopidogrel 150 mg and 100 mg aspirin during the 1st MD period.
1170261|NCT00385944|E4|Reported Event|Clopidogrel 150 mg - Crossover From Prasugrel 10 mg|Once daily MD of clopidogrel 150 mg and 100 mg aspirin, for an additional 14 days. These are patients who received a daily MD of prasugrel 10 mg and 100 mg aspirin during the 1st MD period.
1170262|NCT00385944|E3|Reported Event|Clopidogrel 150 mg - 1st MD|Once daily MD of clopidogrel 150 mg and 100 mg aspirin, for 14 days.
1170263|NCT00385944|E2|Reported Event|Prasugrel 10 mg - 1st MD|Once daily MD of prasugrel 10 mg and 100 mg aspirin, for 14 days.
1170264|NCT00385944|E1|Reported Event|Clopidogrel 900 mg LD|One time oral loading dose (LD) of 900-mg clopidogrel
1170265|NCT00385918|B3|Baseline|Total|Total of all reporting groups
1170266|NCT00385918|B2|Baseline|Home Stretching Then Lokomat Exercise|"Patients will participate in a home stretching program for 3 months. They will then be crossed over to Lokomat treatment for an additional 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm."
1170267|NCT00385918|B1|Baseline|Lokomat Exercise|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
1170268|NCT00385918|P3|Participant Flow|Baseline and Feasibility Testing|All subjects were screened and underwent baseline testing prior to randomization into either the Lokomat training or the Home stretching then Lokomat training group.
1170269|NCT00385918|P2|Participant Flow|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.~After 3 months the participants will be switched to a 3 month period of Lokomat training the same as that offered to the patients randomized to the Lokomat Training arm of the study."
1170270|NCT00385918|P1|Participant Flow|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
1170271|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.~The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
1170272|NCT00385918|O1|Outcome|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
1170273|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.~The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
1170274|NCT00385918|O1|Outcome|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
1170275|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.~The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
1170312|NCT00385840|E2|Reported Event|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1170276|NCT00385918|O1|Outcome|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
1170277|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.~The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
1170278|NCT00385918|O1|Outcome|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
1170279|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.~The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
1170280|NCT00385918|O1|Outcome|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
1170281|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.~The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
1170282|NCT00385918|O1|Outcome|Lokomat Treatment|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
1170283|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.~The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
1170284|NCT00385918|O1|Outcome|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
1170285|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.~The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
1170286|NCT00385918|O1|Outcome|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
1170287|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.~The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
1170288|NCT00385918|O1|Outcome|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
1170289|NCT00385918|E2|Reported Event|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.This group will switch to the 3-month robotic intervention after completing the home-based training program."
1170345|NCT00385801|O1|Outcome|Placebo|Identical placebo tablets and injections
1170346|NCT00385801|O2|Outcome|Risperidone|Risperidone 1-2 mg tablets and Risperidone 25 mg injections
1170347|NCT00385801|O1|Outcome|Placebo|Identical placebo tablets and injections
1170290|NCT00385918|E1|Reported Event|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
1170291|NCT00385840|B3|Baseline|Total|Total of all reporting groups
1170292|NCT00385840|B2|Baseline|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1170293|NCT00385840|B1|Baseline|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1170294|NCT00385840|P2|Participant Flow|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1170295|NCT00385840|P1|Participant Flow|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1170296|NCT00385840|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1170297|NCT00385840|O1|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1170298|NCT00385840|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1170299|NCT00385840|O1|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1170370|NCT00385736|O2|Outcome|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
1170300|NCT00385840|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1170301|NCT00385840|O1|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1170302|NCT00385840|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1170303|NCT00385840|O1|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1170304|NCT00385840|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1170305|NCT00385840|O1|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1170306|NCT00385840|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1170307|NCT00385840|O1|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1170308|NCT00385840|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1170309|NCT00385840|O1|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1170310|NCT00385840|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1170311|NCT00385840|O1|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1170313|NCT00385840|E1|Reported Event|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1170314|NCT00385827|B4|Baseline|Total|Total of all reporting groups
1170315|NCT00385827|B3|Baseline|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
1170316|NCT00385827|B2|Baseline|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
1170317|NCT00385827|B1|Baseline|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
1170318|NCT00385827|P3|Participant Flow|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
1170319|NCT00385827|P2|Participant Flow|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
1170320|NCT00385827|P1|Participant Flow|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
1170321|NCT00385827|O3|Outcome|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
1170322|NCT00385827|O2|Outcome|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
1170323|NCT00385827|O1|Outcome|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
1170324|NCT00385827|O3|Outcome|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
1170325|NCT00385827|O2|Outcome|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
1170326|NCT00385827|O1|Outcome|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
1170348|NCT00385801|O2|Outcome|Risperidone Consta|Risperidone 1-2 mg tablets and Risperidone 25 mg injections
1170349|NCT00385801|O1|Outcome|Placebo|Identical placebo tablets and injections
1170350|NCT00385801|O2|Outcome|Risperidone Consta|Risperidone 1-2 mg tablets and Risperidone 25 mg injections
1170351|NCT00385801|O1|Outcome|Placebo|Identical placebo tablets and injections
1170327|NCT00385827|O3|Outcome|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
1170328|NCT00385827|O2|Outcome|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
1170329|NCT00385827|O1|Outcome|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
1170330|NCT00385827|O3|Outcome|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
1170331|NCT00385827|O2|Outcome|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
1170332|NCT00385827|O1|Outcome|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
1170406|NCT00385723|P2|Participant Flow|1.25 g/d n-3|Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
1170333|NCT00385827|O2|Outcome|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
1170334|NCT00385827|O1|Outcome|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
1170335|NCT00385827|O1|Outcome|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
1170336|NCT00385827|E3|Reported Event|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
1170337|NCT00385827|E2|Reported Event|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
1170338|NCT00385827|E1|Reported Event|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
1170339|NCT00385801|B3|Baseline|Total|Total of all reporting groups
1170340|NCT00385801|B2|Baseline|Risperidone Consta|Risperidone 1-2 mg tablets and Risperidone 25 mg injections
1170341|NCT00385801|B1|Baseline|Placebo|Identical placebo tablets and injections
1170342|NCT00385801|P2|Participant Flow|Risperidone Consta|Risperidone 1-2 mg tablets and Risperidone 25 mg injections
1170343|NCT00385801|P1|Participant Flow|Placebo|Identical placebo tablets and injections
1170344|NCT00385801|O2|Outcome|Risperidone Consta|Risperidone 1-2 mg tablets and Risperidone 25 mg injections
1170353|NCT00385801|E1|Reported Event|Placebo|Identical placebo tablets and injections
1170354|NCT00385736|B4|Baseline|Total|Total of all reporting groups
1170355|NCT00385736|B3|Baseline|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
1170356|NCT00385736|B2|Baseline|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
1170357|NCT00385736|B1|Baseline|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
1170358|NCT00385736|P3|Participant Flow|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
1170359|NCT00385736|P2|Participant Flow|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
1170360|NCT00385736|P1|Participant Flow|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
1170361|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
1170362|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
1170363|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
1170364|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
1170365|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
1170366|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
1170367|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
1170368|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
1170369|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
1170371|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
1170372|NCT00385736|O2|Outcome|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
1170373|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
1170374|NCT00385736|O2|Outcome|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
1170375|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
1170376|NCT00385736|O2|Outcome|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
1170377|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
1170378|NCT00385736|O2|Outcome|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
1170379|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
1170380|NCT00385736|O2|Outcome|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
1170381|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
1170382|NCT00385736|O2|Outcome|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
1170383|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
1170384|NCT00385736|O2|Outcome|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
1170385|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
1170386|NCT00385736|O2|Outcome|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
1170387|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
1170388|NCT00385736|O2|Outcome|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
1170389|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
1170390|NCT00385736|O2|Outcome|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
1170391|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
1170392|NCT00385736|O2|Outcome|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
1170393|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
1170394|NCT00385736|O3|Outcome|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
1170395|NCT00385736|O2|Outcome|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
1170396|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
1170397|NCT00385736|E4|Reported Event|Any Adalimumab|Treatment group received at least 1 dose of adalimumab during the study. Adverse events include those reported from the first dose of adalimumab during the double-blind or open-label period.
1170398|NCT00385736|E3|Reported Event|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4. Adverse events include those reported prior to dosing at Week 8.
1170399|NCT00385736|E2|Reported Event|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4. Adverse events include those reported prior to dosing at Week 8.
1170400|NCT00385736|E1|Reported Event|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6. Adverse events include those reported prior to dosing at Week 8.
1170401|NCT00385723|B4|Baseline|Total|Total of all reporting groups
1170402|NCT00385723|B3|Baseline|2.5 g/d n-3|Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
1170403|NCT00385723|B2|Baseline|1.25 g/d n-3|Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
1170404|NCT00385723|B1|Baseline|Placebo|Placebo : matching placebo capsule daily for 4 months
1170405|NCT00385723|P3|Participant Flow|2.5 g/d n-3|Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
1170407|NCT00385723|P1|Participant Flow|Placebo|Placebo : matching placebo capsule daily for 4 months
1170408|NCT00385723|O3|Outcome|2.5 g/d n-3|Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
1170409|NCT00385723|O2|Outcome|1.25 g/d n-3|Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
1170410|NCT00385723|O1|Outcome|Placebo|Placebo : matching placebo capsule daily for 4 months
1170411|NCT00385723|O3|Outcome|2.5 g/d n-3|Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
1170412|NCT00385723|O2|Outcome|1.25 g/d n-3|Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
1170413|NCT00385723|O1|Outcome|Placebo|Placebo : matching placebo capsule daily for 4 months
1170414|NCT00385723|O3|Outcome|2.5 g/d n-3|Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
1170415|NCT00385723|O2|Outcome|1.25 g/d n-3|Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
1170416|NCT00385723|O1|Outcome|Placebo|Placebo : matching placebo capsule daily for 4 months
1170417|NCT00385723|E3|Reported Event|2.5 g/d n-3|Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
1170418|NCT00385723|E2|Reported Event|1.25 g/d n-3|Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
1170419|NCT00385723|E1|Reported Event|Placebo|Placebo : matching placebo capsule daily for 4 months
1170420|NCT00385684|B1|Baseline|ALL STUDY PARTICIPANTS|"This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.~Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen."
1170421|NCT00385684|P2|Participant Flow|A2 THEN A1 Then Phase B|"This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.~Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen."
1170422|NCT00385684|P1|Participant Flow|A1 and Then A2 Then Phase B|"This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.~Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen."
1170423|NCT00385684|O1|Outcome|Phase B: Open Label|Those participants for whom the study medication was tolerated during Phase A (i.e., the closed label, double-blind phase of the trial) entered a six-week open-label phase.
1170450|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170451|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170424|NCT00385684|O2|Outcome|Placebo Comparator: A2|"This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.~Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen."
1170425|NCT00385684|O1|Outcome|Experimental: A1|"This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.~Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen."
1170426|NCT00385684|E1|Reported Event|ALL STUDY PARTICIPANTS|"This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.~Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen."
1170427|NCT00385671|B4|Baseline|Total|Total of all reporting groups
1170428|NCT00385671|B3|Baseline|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170429|NCT00385671|B2|Baseline|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170430|NCT00385671|B1|Baseline|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170431|NCT00385671|P3|Participant Flow|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170432|NCT00385671|P2|Participant Flow|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170433|NCT00385671|P1|Participant Flow|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170434|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170435|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170436|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170437|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170438|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170439|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170440|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170441|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170442|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170443|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170444|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170445|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170446|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170447|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170448|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170449|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170452|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170453|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170454|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170455|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170456|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170457|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170458|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170459|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170460|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170461|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170462|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170497|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170463|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170464|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170465|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170466|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170467|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170468|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170469|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170470|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170471|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170472|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170473|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170474|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170475|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170476|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170477|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170478|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170479|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170480|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170481|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170482|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170483|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170484|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170520|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170485|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170486|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170487|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170488|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170489|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170490|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170491|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170492|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170493|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170494|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170495|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170496|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170866|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
1170498|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170499|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170500|NCT00385671|O1|Outcome|Ordinary Coefficient|Beta-coefficient from regression analyses estimating direct and indirect treatment effects expressed in the observed scale of measurement of the dependent variable.
1170501|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170502|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170503|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170504|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170505|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170506|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170507|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170508|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170509|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170510|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170511|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170512|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170513|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170514|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170515|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170516|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170517|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170518|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170519|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170521|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170522|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170523|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170524|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170525|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170526|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170527|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170528|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170529|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170530|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170531|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170532|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170533|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170534|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170535|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170536|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170537|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170538|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170539|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170540|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170541|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170542|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170543|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170544|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170545|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170546|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170547|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170548|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170549|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170550|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170551|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170552|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170553|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170554|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170696|NCT00385580|E1|Reported Event|Dasatinib|All treated participants
1170555|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170556|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170557|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170558|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170559|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170560|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170561|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170562|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170563|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170564|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170565|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170566|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170867|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
1170567|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170568|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170569|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170570|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170571|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170572|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170573|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170574|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170575|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170576|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170577|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170578|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170579|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170580|NCT00385671|O1|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170581|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170582|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170583|NCT00385671|E3|Reported Event|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
1170584|NCT00385671|E2|Reported Event|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
1170585|NCT00385671|E1|Reported Event|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
1170586|NCT00385593|B3|Baseline|Total|Total of all reporting groups
1170587|NCT00385593|B2|Baseline|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
1170588|NCT00385593|B1|Baseline|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
1170697|NCT00385541|B3|Baseline|Total|Total of all reporting groups
1170698|NCT00385541|B2|Baseline|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
1170589|NCT00385593|P2|Participant Flow|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
1170590|NCT00385593|P1|Participant Flow|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
1170591|NCT00385593|O2|Outcome|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
1170592|NCT00385593|O1|Outcome|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
1170593|NCT00385593|O2|Outcome|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
1170594|NCT00385593|O1|Outcome|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
1170595|NCT00385593|O2|Outcome|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
1170596|NCT00385593|O1|Outcome|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
1170597|NCT00385593|O2|Outcome|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
1170598|NCT00385593|O1|Outcome|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
1170599|NCT00385593|O2|Outcome|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
1170600|NCT00385593|O1|Outcome|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
1170601|NCT00385593|O2|Outcome|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
1170602|NCT00385593|O1|Outcome|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
1170603|NCT00385593|E2|Reported Event|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
1170604|NCT00385593|E1|Reported Event|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
1170605|NCT00385580|B3|Baseline|Total|Total of all reporting groups
1170606|NCT00385580|B2|Baseline|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170607|NCT00385580|B1|Baseline|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170608|NCT00385580|P2|Participant Flow|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170609|NCT00385580|P1|Participant Flow|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170610|NCT00385580|O3|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (X dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170611|NCT00385580|O2|Outcome|Dasatinib 100 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (X dose). Of the 47 treated participants in the BID group, 25 received 100 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170699|NCT00385541|B1|Baseline|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
1170700|NCT00385541|P2|Participant Flow|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
1170840|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
1170612|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD (50 dose). Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170613|NCT00385580|O3|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (50 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170614|NCT00385580|O2|Outcome|Dasatinib 100 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (50 dose). Of the 47 treated participants in the BID group, 25 received 100 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170615|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD (50 dose). Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170616|NCT00385580|O3|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (70 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170722|NCT00385515|O1|Outcome|SNX-1012|SNX-1012 (meclocycline sulfosalicylate) tablets dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days
1170723|NCT00385268|B3|Baseline|Total|Total of all reporting groups
1170724|NCT00385268|B2|Baseline|Placebo|"placebo pills for 8 weeks~Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.~placebo : placebo pills"
1170953|NCT00384241|B3|Baseline|Total|Total of all reporting groups
1170617|NCT00385580|O2|Outcome|Dasatinib 100 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (70 dose). Of the 47 treated participants in the BID group, 25 received 100 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170618|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD (70 dose). Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170619|NCT00385580|O3|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (70 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170620|NCT00385580|O2|Outcome|Dasatinib 100 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (70 dose). Of the 47 treated participants in the BID group, 25 received 100 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170621|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD (70 dose). Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170622|NCT00385580|O3|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170623|NCT00385580|O2|Outcome|Dasatinib 100 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (100 dose). Of the 47 treated participants in the BID group, 25 received 100 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170624|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD (100 dose). Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170625|NCT00385580|O3|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170626|NCT00385580|O2|Outcome|Dasatinib 100 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (100 dose). Of the 47 treated participants in the BID group, 25 received 100 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170627|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD (100 dose). Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170628|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170629|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170630|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170631|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170632|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170633|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170634|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170635|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170701|NCT00385541|P1|Participant Flow|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
1170702|NCT00385541|O2|Outcome|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
1170703|NCT00385541|O1|Outcome|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
1170704|NCT00385541|O2|Outcome|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
1170636|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170637|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170638|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170639|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170640|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170641|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170725|NCT00385268|B1|Baseline|Acamprosate|"1998mg/day for 8 weeks~Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.~acamprosate : 1998 mg/dau fpr 8 weeks"
1170726|NCT00385268|P2|Participant Flow|Placebo|"placebo pills for 8 weeks~Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.~placebo : placebo pills"
1171237|NCT00383747|E2|Reported Event|Controls|
1170642|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170643|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170644|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170645|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170646|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170647|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170648|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170649|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170650|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170651|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170652|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170653|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170727|NCT00385268|P1|Participant Flow|Acamprosate|"1998mg/day for 8 weeks~Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.~acamprosate : 1998 mg/dau fpr 8 weeks"
1170728|NCT00385268|O2|Outcome|Placebo|"placebo pills for 8 weeks~Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.~placebo : placebo pills"
1171238|NCT00383747|E1|Reported Event|Non Smokers With Schizophrenia|
1170654|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170655|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170656|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170657|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170658|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170659|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170660|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170661|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170662|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170663|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170664|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170665|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170729|NCT00385268|O1|Outcome|Acamprosate|"1998mg/day for 8 weeks~Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.~acamprosate : 1998 mg/dau fpr 8 weeks"
1170730|NCT00385268|E2|Reported Event|Placebo|"placebo pills for 8 weeks~Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.~placebo : placebo pills"
1171239|NCT00383721|B6|Baseline|Total|Total of all reporting groups
1170666|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170667|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170668|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170669|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170670|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170671|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170672|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170673|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170674|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170675|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170676|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170677|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170731|NCT00385268|E1|Reported Event|Acamprosate|"1998mg/day for 8 weeks~Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.~acamprosate : 1998 mg/dau fpr 8 weeks"
1170732|NCT00385216|B1|Baseline|Entire Study Population|The baseline characteristics for the entire study population are presented here. The nicotine and placebo study populations were identical.
1170678|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170679|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170680|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170681|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170682|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170683|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170684|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170685|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170686|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170687|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170688|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170689|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170733|NCT00385216|P2|Participant Flow|Placebo Spray First, Then Nicotine|At the first intervention, the subject will receive a placebo nasal spray, 0 mg, one application. At the second intervention, the subject will receive a nicotine nasal spray, 3 mg, one application.
1170868|NCT00384930|O3|Outcome|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
1170690|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170691|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170692|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170693|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170694|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170695|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1170705|NCT00385541|O1|Outcome|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
1170706|NCT00385541|O2|Outcome|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
1170707|NCT00385541|O1|Outcome|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
1170708|NCT00385541|O2|Outcome|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
1170709|NCT00385541|O1|Outcome|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
1170710|NCT00385541|O2|Outcome|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
1170711|NCT00385541|O1|Outcome|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
1170712|NCT00385541|E2|Reported Event|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
1170713|NCT00385541|E1|Reported Event|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
1170714|NCT00385515|B3|Baseline|Total|Total of all reporting groups
1170715|NCT00385515|B2|Baseline|Placebo|Placebo tablets (matched to SNX-1012) dissolved in water for oral swish and expectorate; 4 times daily for 10 days
1170716|NCT00385515|B1|Baseline|SNX-1012|SNX-1012 (meclocycline sulfosalicylate) tablets dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days
1170717|NCT00385515|P2|Participant Flow|Placebo|Placebo tablets (matched to SNX-1012) dissolved in water for oral swish and expectorate; 4 times daily for 10 days
1170718|NCT00385515|P1|Participant Flow|SNX-1012|SNX-1012 (meclocycline sulfosalicylate) tablets dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days
1170719|NCT00385515|O2|Outcome|Placebo|Placebo tablets (matched to SNX-1012) dissolved in water for oral swish and expectorate; 4 times daily for 10 days
1170720|NCT00385515|O1|Outcome|SNX-1012|SNX-1012 (meclocycline sulfosalicylate) tablets dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days
1170721|NCT00385515|O2|Outcome|Placebo|Placebo tablets (matched to SNX-1012) dissolved in water for oral swish and expectorate; 4 times daily for 10 days
1171240|NCT00383721|B5|Baseline|Placebo|Placebo MDI BID for 26 weeks.
1170734|NCT00385216|P1|Participant Flow|Nicotine Nasal Spray First, Then Placebo|At the first intervention, the subject will receive a nicotine nasal spray, 3 mg, one application. At the second intervention, the subject will receive a placebo nasal spray, 0 mg, one application.
1170735|NCT00385216|O2|Outcome|Placebo|Sterile saline placebo was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
1170736|NCT00385216|O1|Outcome|Nicotine Nasal Spray|Nicotine nasal spray (3mg) was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
1170737|NCT00385216|O2|Outcome|Placebo|Sterile saline placebo was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
1170738|NCT00385216|O1|Outcome|Nicotine Nasal Spray|Nicotine nasal spray (3mg) was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
1170739|NCT00385216|O2|Outcome|Placebo|Sterile saline placebo was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
1170740|NCT00385216|O1|Outcome|Nicotine Nasal Spray|Nicotine nasal spray (3mg) was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
1170741|NCT00385216|O2|Outcome|Placebo|Sterile saline placebo was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
1170742|NCT00385216|O1|Outcome|Nicotine Nasal Spray|Nicotine nasal spray (3mg) was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
1170743|NCT00385216|E2|Reported Event|Placebo|Sterile saline nasal spray was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
1170744|NCT00385216|E1|Reported Event|Nicotine Nasal Spray|Nicotine nasal spray (3mg) was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
1170745|NCT00385203|B3|Baseline|Total|Total of all reporting groups
1170746|NCT00385203|B2|Baseline|Cediranib 45 mg/Day STS|Cediranib 45 mg/Day: 10 patients with Soft Tissue Sarcomas (STS) randomised
1170747|NCT00385203|B1|Baseline|Cediranib 45 mg/Day GIST|Cediranib 45 mg/Day: 25 patients with Gastrointestinal Stromal Tumour (GIST) randomised
1170748|NCT00385203|P2|Participant Flow|Cediranib 45 mg/Day STS|10 Soft Tissue Sarcomas (STS) patients were randomised.
1170749|NCT00385203|P1|Participant Flow|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
1170750|NCT00385203|O2|Outcome|Cediranib 45 mg/Day STS|10 Soft Tissue Sarcomas (STS) patients were randomised.
1170751|NCT00385203|O1|Outcome|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
1170752|NCT00385203|O2|Outcome|Cediranib 45 mg/Day STS|10 Soft Tissue Sarcomas (STS) patients were randomised.
1170753|NCT00385203|O1|Outcome|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
1170754|NCT00385203|O2|Outcome|Cediranib 45 mg/Day STS|10 Soft Tissue Sarcomas (STS) patients were randomised.
1170755|NCT00385203|O1|Outcome|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
1170756|NCT00385203|O2|Outcome|Cediranib 45 mg/Day STS|10 Soft Tissue Sarcomas (STS) patients were randomised.
1170757|NCT00385203|O1|Outcome|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
1170758|NCT00385203|O2|Outcome|Cediranib 45 mg/Day STS|10 Soft Tissue Sarcomas (STS) patients were randomised.
1170759|NCT00385203|O1|Outcome|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
1170760|NCT00385203|O2|Outcome|Cediranib 45 mg/Day STS|10 Soft Tissue Sarcomas (STS) patients were randomised.
1170761|NCT00385203|O1|Outcome|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
1170762|NCT00385203|O2|Outcome|Cediranib 45 mg/Day STS|Cediranib 45 mg/Day patients with Soft Tissue Sarcomas (STS): 10 patients randomised and received at least one dose of treatment
1170763|NCT00385203|O1|Outcome|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
1170764|NCT00385203|E2|Reported Event|Cediranib 45 mg/Day STS|Cediranib 45 mg/Day patients with Soft Tissue Sarcomas (STS): 10 patients randomised and received at least one dose of treatment.
1170765|NCT00385203|E1|Reported Event|Cediranib 45 mg/Day GIST|Cediranib 45 mg/Day patients with Gastrointestinal Stromal Tumour (GIST): 24 patients randomised and received at least one dose of treatment (1 patient was not randomised or dosed and a further 1 patient was randomised but not dosed due to Incorrect enrolmentCediranib)
1170766|NCT00385138|B3|Baseline|Total|Total of all reporting groups
1170767|NCT00385138|B2|Baseline|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
1170864|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
1170865|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
1171525|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
1170768|NCT00385138|B1|Baseline|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
1170769|NCT00385138|P2|Participant Flow|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
1170770|NCT00385138|P1|Participant Flow|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
1170771|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
1170772|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
1170773|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
1170774|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
1170775|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
1170776|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
1170777|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
1170778|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
1170779|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
1170780|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
1170781|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
1170782|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
1170783|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
1171664|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
1170784|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
1170785|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
1170786|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
1170787|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
1170788|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
1170789|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
1170790|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
1170791|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
1170792|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
1170793|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
1170794|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
1170795|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
1170796|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
1170797|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
1170798|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
1170799|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
1170800|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
1170801|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
1170802|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
1170803|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
1170804|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
1170805|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
1170806|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
1170807|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
1170808|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
1170809|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
1170810|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
1170811|NCT00385138|E2|Reported Event|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
1170812|NCT00385138|E1|Reported Event|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
1170813|NCT00384956|B1|Baseline|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
1170814|NCT00384956|P1|Participant Flow|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
1170815|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
1170816|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
1170817|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
1170818|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
1170819|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
1170820|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
1170821|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
1170822|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
1170823|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
1170824|NCT00384956|E1|Reported Event|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
1170825|NCT00384930|B6|Baseline|Total|Total of all reporting groups
1170826|NCT00384930|B5|Baseline|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
1170827|NCT00384930|B4|Baseline|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
1170828|NCT00384930|B3|Baseline|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
1170829|NCT00384930|B2|Baseline|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
1170830|NCT00384930|B1|Baseline|Placebo|placebo tablet by mouth once a day for twelve weeks
1170831|NCT00384930|P5|Participant Flow|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
1170832|NCT00384930|P4|Participant Flow|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
1170833|NCT00384930|P3|Participant Flow|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
1170834|NCT00384930|P2|Participant Flow|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
1170835|NCT00384930|P1|Participant Flow|Placebo|placebo tablet by mouth once a day for twelve weeks
1170836|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
1170837|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
1170838|NCT00384930|O3|Outcome|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
1170839|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
1171665|NCT00382993|O1|Outcome|Placebo|
1170841|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
1170842|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
1170843|NCT00384930|O3|Outcome|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
1170844|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
1170845|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
1170846|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
1170847|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
1170848|NCT00384930|O3|Outcome|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
1170849|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
1170850|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
1170851|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
1170852|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
1170853|NCT00384930|O3|Outcome|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
1170854|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
1170855|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
1170856|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
1170857|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
1170858|NCT00384930|O3|Outcome|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
1170859|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
1170860|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
1170861|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
1170862|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
1170863|NCT00384930|O3|Outcome|5.0 mg Tadalafil|5.0 mg tadalafil tablet by mouth once a day for twelve weeks
1171526|NCT00383162|O1|Outcome|Placebo|
1170869|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
1170870|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
1170871|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
1170872|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
1170873|NCT00384930|O3|Outcome|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
1170874|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
1170875|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
1170876|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
1170877|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
1170878|NCT00384930|O3|Outcome|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
1170879|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
1170880|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
1170881|NCT00384930|O2|Outcome|5 mg Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
1170882|NCT00384930|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
1170883|NCT00384930|E5|Reported Event|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
1170884|NCT00384930|E4|Reported Event|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
1170885|NCT00384930|E3|Reported Event|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
1170886|NCT00384930|E2|Reported Event|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
1170887|NCT00384930|E1|Reported Event|Placebo|placebo tablet by mouth once a day for twelve weeks
1170888|NCT00384813|B3|Baseline|Total|Total of all reporting groups
1170889|NCT00384813|B2|Baseline|2: Enhanced Treatment As Usual|"Enhanced Treatment As Usual (1 home visit)~Project ASPIRE Enhanced Treatment As Usual : Psychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist"
1170890|NCT00384813|B1|Baseline|1: Home-based Family Intervention|"Home-based family intervention~Project ASPIRE Home-Based Family Intervention : Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months"
1170891|NCT00384813|P2|Participant Flow|2: Enhanced Treatment As Usual|"Enhanced Treatment As Usual (1 home visit)~Project ASPIRE Enhanced Treatment As Usual : Psychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist"
1170892|NCT00384813|P1|Participant Flow|1: Home-based Family Intervention|"Home-based family intervention~Project ASPIRE Home-Based Family Intervention : Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months"
1170893|NCT00384813|O2|Outcome|2: Enhanced Treatment As Usual|"Enhanced Treatment As Usual (1 home visit)~Project ASPIRE Enhanced Treatment As Usual : Psychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist"
1170894|NCT00384813|O1|Outcome|1: Home-based Family Intervention|"Home-based family intervention~Project ASPIRE Home-Based Family Intervention : Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months"
1170895|NCT00384813|E2|Reported Event|2: Enhanced Treatment As Usual|"Enhanced Treatment As Usual (1 home visit)~Project ASPIRE Enhanced Treatment As Usual : Psychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist"
1170934|NCT00384397|O1|Outcome|Group 1: Menactra® Vaccine|Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
1170896|NCT00384813|E1|Reported Event|1: Home-based Family Intervention|"Home-based family intervention~Project ASPIRE Home-Based Family Intervention : Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months"
1170897|NCT00384748|B3|Baseline|Total|Total of all reporting groups
1170898|NCT00384748|B2|Baseline|Arm 2|"Patients randomized to the Usual Care group receive routine VA care, as directed by their physicians.~Receipt of therapy services will be tracked via a weekly diary for the entire 6 months of the intervention period. In this weekly diary, patients in both the usual care and intervention group will record receipt of therapy. The patients will be asked to include the time in minutes that they spent in receipt of therapy services. Both groups will also be asked whether or not they exercised, and if so how frequently. TR and Usual Care participants will be administered telephone interviews at baseline, 3-and 6-months. The interview outcome measures are FONEFIM, Late-Life Function and Disability Instrument, Falls Self Efficacy Scale and Stroke Specific Patient Satisfaction with Care. In addition, sociodemographics, stroke severity, length of time since stroke onset, and depression at baseline will be measured.~Usual care: Routine VA care."
1170899|NCT00384748|B1|Baseline|Arm 1|"TR intervention consists of two parts 1) exercise targeting underlying stroke-related impairment and 2) adaptive strategies to help compensate for disability. An in-home messaging device is used to facilitate adherence with treatment recommendations and to screen for problems. This will allow targeted evaluations of problem areas during tele-visits, rapid response to new functional problems.~The 3 tele-visits will occur within 5 weeks post randomization. Telephone call visits will occur during even weeks.The first visit is devoted to mobility assessment, goal-setting. The second visit is to review the current exercise component. In-home messaging device. The teletherapist receives the clinical data from the in-home messaging device on a daily basis to screen for depression, lower extremity strength, self-care tasks and mobility, falls and exercise adherence."
1170914|NCT00384670|O1|Outcome|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
1170915|NCT00384670|E1|Reported Event|Dengue Vaccine and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
1170916|NCT00384397|B4|Baseline|Total|Total of all reporting groups
1170917|NCT00384397|B3|Baseline|Group 3: Menactra® + PCV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
1170900|NCT00384748|P2|Participant Flow|Arm 2|"Patients randomized to the Usual Care group receive routine VA care, as directed by their physicians.~Receipt of therapy services will be tracked via a weekly diary for the entire 6 months of the intervention period. In this weekly diary, patients in both the usual care and intervention group will record receipt of therapy. The patients will be asked to include the time in minutes that they spent in receipt of therapy services. Both groups will also be asked whether or not they exercised, and if so how frequently. TR and Usual Care participants will be administered telephone interviews at baseline, 3-and 6-months. The interview outcome measures are FONEFIM, Late-Life Function and Disability Instrument, Falls Self Efficacy Scale and Stroke Specific Patient Satisfaction with Care. In addition, sociodemographics, stroke severity, length of time since stroke onset, and depression at baseline will be measured.~Usual care: Routine VA care."
1170901|NCT00384748|P1|Participant Flow|Arm 1|"TR intervention consists of two parts 1) exercise targeting underlying stroke-related impairment and 2) adaptive strategies to help compensate for disability. An in-home messaging device is used to facilitate adherence with treatment recommendations and to screen for problems. This will allow targeted evaluations of problem areas during tele-visits, rapid response to new functional problems.~The 3 tele-visits will occur within 5 weeks post randomization. Telephone call visits will occur during even weeks.The first visit is devoted to mobility assessment, goal-setting. The second visit is to review the current exercise component. In-home messaging device. The teletherapist receives the clinical data from the in-home messaging device on a daily basis to screen for depression, lower extremity strength, self-care tasks and mobility, falls and exercise adherence."
1170902|NCT00384748|O2|Outcome|Arm 2|"Patients randomized to the Usual Care group receive routine VA care, as directed by their physicians.~Receipt of therapy services will be tracked via a weekly diary for the entire 6 months of the intervention period. In this weekly diary, patients in both the usual care and intervention group will record receipt of therapy. The patients will be asked to include the time in minutes that they spent in receipt of therapy services. Both groups will also be asked whether or not they exercised, and if so how frequently. TR and Usual Care participants will be administered telephone interviews at baseline, 3-and 6-months. The interview outcome measures are FONEFIM, Late-Life Function and Disability Instrument, Falls Self Efficacy Scale and Stroke Specific Patient Satisfaction with Care. In addition, sociodemographics, stroke severity, length of time since stroke onset, and depression at baseline will be measured.~Usual care: Routine VA care."
1170903|NCT00384748|O1|Outcome|Arm 1|"TR intervention consists of two parts 1) exercise targeting underlying stroke-related impairment and 2) adaptive strategies to help compensate for disability. An in-home messaging device is used to facilitate adherence with treatment recommendations and to screen for problems. This will allow targeted evaluations of problem areas during tele-visits, rapid response to new functional problems.~The 3 tele-visits will occur within 5 weeks post randomization. Telephone call visits will occur during even weeks.The first visit is devoted to mobility assessment, goal-setting. The second visit is to review the current exercise component. In-home messaging device. The teletherapist receives the clinical data from the in-home messaging device on a daily basis to screen for depression, lower extremity strength, self-care tasks and mobility, falls and exercise adherence."
1170935|NCT00384397|E3|Reported Event|Group 3: Menactra® + PCV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
1170936|NCT00384397|E2|Reported Event|Group 2: Menactra® + MMRV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
1170937|NCT00384397|E1|Reported Event|Group 1: Menactra® Vaccine|Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
1170938|NCT00384293|B3|Baseline|Total|Total of all reporting groups
1170904|NCT00384748|E2|Reported Event|Arm 2|"Patients randomized to the Usual Care group receive routine VA care, as directed by their physicians.~Receipt of therapy services will be tracked via a weekly diary for the entire 6 months of the intervention period. In this weekly diary, patients in both the usual care and intervention group will record receipt of therapy. The patients will be asked to include the time in minutes that they spent in receipt of therapy services. Both groups will also be asked whether or not they exercised, and if so how frequently. TR and Usual Care participants will be administered telephone interviews at baseline, 3-and 6-months. The interview outcome measures are FONEFIM, Late-Life Function and Disability Instrument, Falls Self Efficacy Scale and Stroke Specific Patient Satisfaction with Care. In addition, sociodemographics, stroke severity, length of time since stroke onset, and depression at baseline will be measured.~Usual care: Routine VA care."
1170905|NCT00384748|E1|Reported Event|Arm 1|"TR intervention consists of two parts 1) exercise targeting underlying stroke-related impairment and 2) adaptive strategies to help compensate for disability. An in-home messaging device is used to facilitate adherence with treatment recommendations and to screen for problems. This will allow targeted evaluations of problem areas during tele-visits, rapid response to new functional problems.~The 3 tele-visits will occur within 5 weeks post randomization. Telephone call visits will occur during even weeks.The first visit is devoted to mobility assessment, goal-setting. The second visit is to review the current exercise component. In-home messaging device. The teletherapist receives the clinical data from the in-home messaging device on a daily basis to screen for depression, lower extremity strength, self-care tasks and mobility, falls and exercise adherence."
1170906|NCT00384670|B1|Baseline|Dengue Vaccine and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
1170907|NCT00384670|P1|Participant Flow|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
1170908|NCT00384670|O1|Outcome|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
1170909|NCT00384670|O1|Outcome|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
1170910|NCT00384670|O1|Outcome|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
1170911|NCT00384670|O1|Outcome|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
1170912|NCT00384670|O1|Outcome|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
1170913|NCT00384670|O1|Outcome|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
1170918|NCT00384397|B2|Baseline|Group 2: Menactra® + MMRV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
1170919|NCT00384397|B1|Baseline|Group 1: Menactra® Vaccine|Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
1170920|NCT00384397|P3|Participant Flow|Group 3: Menactra® + PCV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
1170921|NCT00384397|P2|Participant Flow|Group 2: Menactra® + MMRV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
1170922|NCT00384397|P1|Participant Flow|Group 1: Menactra® Vaccine|Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
1170923|NCT00384397|O3|Outcome|Group 3: Menactra® + PCV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
1170924|NCT00384397|O2|Outcome|Group 2: Menactra® + MMRV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
1170925|NCT00384397|O1|Outcome|Group 1: Menactra® Vaccine|Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
1170926|NCT00384397|O3|Outcome|Group 3: Menactra® + PCV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
1170927|NCT00384397|O2|Outcome|Group 2: Menactra® + MMRV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
1170928|NCT00384397|O1|Outcome|Group 1: Menactra® Vaccine|Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
1170929|NCT00384397|O3|Outcome|Group 3: Menactra® + PCV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
1170930|NCT00384397|O2|Outcome|Group 2: Menactra® + MMRV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
1170931|NCT00384397|O1|Outcome|Group 1: Menactra® Vaccine|Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
1170932|NCT00384397|O3|Outcome|Group 3: Menactra® + PCV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
1170933|NCT00384397|O2|Outcome|Group 2: Menactra® + MMRV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
1170939|NCT00384293|B2|Baseline|Placebo (Postrandomization Period)|Patients who were randomized to placebo
1170940|NCT00384293|B1|Baseline|MK0524A, 2 g (Postrandomization Period)|Patients who were randomized to MK0524A, 2 g (oral administration) once daily.
1170941|NCT00384293|P3|Participant Flow|Placebo (Postrandomization Period)|Patients who were randomized to placebo
1170942|NCT00384293|P2|Participant Flow|MK0524A, 2 g (Postrandomization Period)|Patients who were randomized to MK0524A, 2 g (oral administration) once daily.
1170943|NCT00384293|P1|Participant Flow|MK0524A Active Run-In Period|Patients who received MK0524A during active run-in (Visit 2). Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, at Visit 3 for an additional 4 weeks prior to randomization.
1170944|NCT00384293|O3|Outcome|Placebo (Postrandomization Period)|Patients who were randomized to placebo
1170945|NCT00384293|O2|Outcome|MK0524A, 2 g (Postrandomization Period)|Patients who were randomized to MK0524A, 2 g (oral administration) once daily.
1170946|NCT00384293|O1|Outcome|MK0524A Active Run-In Period|Patients who received MK0524A during active run-in (Visit 2). Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, at Visit 3 for an additional 4 weeks prior to randomization.
1170947|NCT00384293|O3|Outcome|Placebo (Postrandomization Period)|Patients who were randomized to placebo
1170948|NCT00384293|O2|Outcome|MK0524A, 2 g (Postrandomization Period)|Patients who were randomized to MK0524A, 2 g (oral administration) once daily.
1170949|NCT00384293|O1|Outcome|MK0524A Active Run-In Period|Patients who received MK0524A during active run-in (Visit 2). Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, at Visit 3 for an additional 4 weeks prior to randomization.
1170950|NCT00384293|E3|Reported Event|Placebo (Postrandomization Period)|Patients who were randomized to placebo
1170951|NCT00384293|E2|Reported Event|MK0524A, 2 g (Postrandomization Period)|Patients who were randomized to MK0524A, 2 g (oral administration) once daily.
1170952|NCT00384293|E1|Reported Event|MK0524A Active Run-In Period|Patients who received MK0524A during active run-in (Visit 2). Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, at Visit 3 for an additional 4 weeks prior to randomization.
1170954|NCT00384241|B2|Baseline|Parents|African American and Caucasian parents, age 18-65.
1170955|NCT00384241|B1|Baseline|Children|African American and Caucasian children age 15-19.
1170956|NCT00384241|P2|Participant Flow|Parents|Buccal swabs from the Parents of 500 subjects in the children arm were collected and analyzed for genetic variations. Some parents submitted duplicate swabs if more than 1 child was represented in the 500 subjects.
1170957|NCT00384241|P1|Participant Flow|Children|Genotyping and IL-6 levels of 500 children enrolled in two previous studies were collected in the current study. Other phenotype data: Baseline blood pressure, stress blood pressure, and recovery blood pressure; Baseline stress and recovery urinary sodium excretion that were collected in two previous studies were utilized in the current study.
1170958|NCT00384241|O1|Outcome|Children|500 children age 15-19, self reported as African American or of European origin, healthy, non-smoker with normal blood pressure that participated in two previous studies
1170959|NCT00384241|O1|Outcome|Children|500 children age 15-19, self reported as African American or of European origin, healthy, non-smoker with normal blood pressure that participated in two previous studies
1170960|NCT00384241|E2|Reported Event|Parents|African American and Caucasian parents age 18 - 65
1170961|NCT00384241|E1|Reported Event|Children|African American and Caucasian children age 15 - 19.
1170962|NCT00384189|B5|Baseline|Total|Total of all reporting groups
1170963|NCT00384189|B4|Baseline|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1170964|NCT00384189|B3|Baseline|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1170965|NCT00384189|B2|Baseline|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1170966|NCT00384189|B1|Baseline|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1170967|NCT00384189|P4|Participant Flow|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1170968|NCT00384189|P3|Participant Flow|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1170969|NCT00384189|P2|Participant Flow|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1171271|NCT00383721|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
1171666|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
1170970|NCT00384189|P1|Participant Flow|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1170971|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1170972|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1170973|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1170974|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1170975|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1170976|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1171078|NCT00384085|O1|Outcome|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
1170977|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1170978|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1170979|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1170980|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1170981|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1170982|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1170983|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1170984|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1170985|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1170986|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1170987|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1171667|NCT00382993|O1|Outcome|Placebo|
1170988|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1170989|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1170990|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1170991|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1170992|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1170993|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1170994|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1171079|NCT00384085|O2|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
1171527|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
1170995|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1170996|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1170997|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1170998|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1170999|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1171000|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1171001|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1171002|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1171003|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1171004|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1171005|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1171006|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1171007|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1171008|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1171009|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1171010|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1171011|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1171012|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1171080|NCT00384085|O1|Outcome|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
1171241|NCT00383721|B4|Baseline|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
1171013|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1171014|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1171015|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1171016|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1171017|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1171018|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1171019|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1171020|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1171021|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1171022|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1171127|NCT00384059|E6|Reported Event|7vPnC Toddler Series|Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
1171023|NCT00384189|E4|Reported Event|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1171024|NCT00384189|E3|Reported Event|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1171025|NCT00384189|E2|Reported Event|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1171026|NCT00384189|E1|Reported Event|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
1171027|NCT00384176|B4|Baseline|Total|Total of all reporting groups
1171028|NCT00384176|B3|Baseline|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
1171029|NCT00384176|B2|Baseline|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks~+ FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
1171030|NCT00384176|B1|Baseline|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
1171081|NCT00384085|E3|Reported Event|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
1171397|NCT00383435|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
1171031|NCT00384176|P3|Participant Flow|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
1171032|NCT00384176|P2|Participant Flow|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
1171033|NCT00384176|P1|Participant Flow|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
1171034|NCT00384176|O3|Outcome|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
1171035|NCT00384176|O2|Outcome|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks~+ FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
1171036|NCT00384176|O1|Outcome|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
1171037|NCT00384176|O3|Outcome|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
1171038|NCT00384176|O2|Outcome|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks~+ FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
1171272|NCT00383721|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
1171039|NCT00384176|O1|Outcome|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
1171040|NCT00384176|O3|Outcome|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
1171041|NCT00384176|O2|Outcome|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks~+ FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
1171042|NCT00384176|O1|Outcome|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
1171043|NCT00384176|O3|Outcome|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
1171044|NCT00384176|O2|Outcome|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks~+ FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
1171045|NCT00384176|O1|Outcome|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
1171082|NCT00384085|E2|Reported Event|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
1171046|NCT00384176|O3|Outcome|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
1171047|NCT00384176|O2|Outcome|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks~+ FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
1171048|NCT00384176|O1|Outcome|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
1171049|NCT00384176|O3|Outcome|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
1171050|NCT00384176|O2|Outcome|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks~+ FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
1171051|NCT00384176|O1|Outcome|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
1171052|NCT00384176|E3|Reported Event|1Bevacizumab 5mg/kg|Bevacizumab 5 mg/kg on Day 1 and every 2 weeks
1171053|NCT00384176|E2|Reported Event|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
1171128|NCT00384059|E5|Reported Event|13vPnC Toddler Series|Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
1171273|NCT00383721|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
1171054|NCT00384176|E1|Reported Event|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
1171055|NCT00384085|B4|Baseline|Total|Total of all reporting groups
1171056|NCT00384085|B3|Baseline|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
1171057|NCT00384085|B2|Baseline|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
1171058|NCT00384085|B1|Baseline|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
1171059|NCT00384085|P3|Participant Flow|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
1171060|NCT00384085|P2|Participant Flow|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
1171061|NCT00384085|P1|Participant Flow|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
1171062|NCT00384085|O3|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
1171063|NCT00384085|O2|Outcome|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
1171064|NCT00384085|O1|Outcome|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
1171065|NCT00384085|O3|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
1171066|NCT00384085|O2|Outcome|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
1171067|NCT00384085|O1|Outcome|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
1171068|NCT00384085|O3|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
1171069|NCT00384085|O2|Outcome|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
1171070|NCT00384085|O1|Outcome|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
1171071|NCT00384085|O2|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
1171072|NCT00384085|O1|Outcome|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
1171073|NCT00384085|O2|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
1171074|NCT00384085|O1|Outcome|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
1171075|NCT00384085|O2|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
1171076|NCT00384085|O1|Outcome|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
1171077|NCT00384085|O2|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
1171519|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
1171083|NCT00384085|E1|Reported Event|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
1171084|NCT00384059|B3|Baseline|Total|Total of all reporting groups
1171085|NCT00384059|B2|Baseline|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
1171086|NCT00384059|B1|Baseline|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
1171087|NCT00384059|P2|Participant Flow|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
1171088|NCT00384059|P1|Participant Flow|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
1171129|NCT00384059|E4|Reported Event|7vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (assessment at 5 months of age, 1 month after the infant series). Pediacel was administered without study vaccine at 3-month visit.
1171089|NCT00384059|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
1171090|NCT00384059|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
1171091|NCT00384059|O6|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Menitorix at 12 months of age.
1171092|NCT00384059|O5|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Menitorix at 12 months of age.
1171093|NCT00384059|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Pediacel at 4 months of age.
1171094|NCT00384059|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Pediacel at 4 months of age.
1171095|NCT00384059|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Pediacel at 2 months of age.
1171096|NCT00384059|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Pediacel at 2 months of age.
1171097|NCT00384059|O6|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Menitorix at 12 months of age.
1171098|NCT00384059|O5|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Menitorix at 12 months of age.
1171099|NCT00384059|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Pediacel at 4 months of age.
1171100|NCT00384059|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Pediacel at 4 months of age.
1171101|NCT00384059|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Pediacel at 2 months of age.
1171102|NCT00384059|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Pediacel at 2 months of age.
1171103|NCT00384059|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits, and Menitorix at the 12-month visit.
1171104|NCT00384059|O2|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits, and Menitorix at the 12-month visit.
1171105|NCT00384059|O1|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits, and Menitorix at the 12-month visit.
1171106|NCT00384059|O3|Outcome|13vPnC After Toddler Dose|Participants received Menitorix at the 12-month visit.
1171186|NCT00383942|P1|Participant Flow|Misoprostol|Patients randomized to this arm receive 25 micrograms of misoprostol every 4 hours.
1171520|NCT00383162|O1|Outcome|Placebo|
1171107|NCT00384059|O2|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits.
1171108|NCT00384059|O1|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits.
1171109|NCT00384059|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
1171110|NCT00384059|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
1171111|NCT00384059|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
1171150|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
1171317|NCT00383552|B4|Baseline|Placebo BID|Placebo twice daily (BID)
1171668|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
1171112|NCT00384059|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
1171113|NCT00384059|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
1171114|NCT00384059|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
1171115|NCT00384059|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
1171116|NCT00384059|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
1171117|NCT00384059|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
1171118|NCT00384059|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
1171119|NCT00384059|O4|Outcome|7vPnC After Toddler Dose|Participants received Menitorix at the 12-month visit.
1171120|NCT00384059|O3|Outcome|13vPnC After Toddler Dose|Participants received Menitorix at the 12-month visit.
1171121|NCT00384059|O2|Outcome|7vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits.
1171122|NCT00384059|O1|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits.
1171123|NCT00384059|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
1171124|NCT00384059|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
1171125|NCT00384059|E8|Reported Event|7vPnC 6-Month Follow-up|Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit(assessment at 18 months of age, 6 months after the toddler dose).
1171126|NCT00384059|E7|Reported Event|13vPnC 6-Month Follow-up|Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) & Meningococcal C Vaccine (Menitorix) at the 12-month visit (assessment at 18 months of age, 6 months after the toddler dose).
1171609|NCT00383071|B3|Baseline|180 mcg Cohort 4|180 mcg IM every 4 weeks for 2 vaccinations
1171130|NCT00384059|E3|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (assessment at 5 months of age, 1 month after the infant series). Pediacel was administered without study vaccine at 3-month visit.
1171131|NCT00384059|E2|Reported Event|7vPnC Infant Series|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits. Pediacel was administered without study vaccine at 3-month visit.
1171132|NCT00384059|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits. Pediacel was administered without study vaccine at 3-month visit.
1171133|NCT00384033|B5|Baseline|Total|Total of all reporting groups
1171134|NCT00384033|B4|Baseline|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
1171135|NCT00384033|B3|Baseline|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171136|NCT00384033|B2|Baseline|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171137|NCT00384033|B1|Baseline|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171138|NCT00384033|P4|Participant Flow|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
1171139|NCT00384033|P3|Participant Flow|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171187|NCT00383942|O2|Outcome|EASI|Patients randomized to this arm recieve extra amniotic saline infusion (EASI) via a catheter that is placed in the uterus
1171528|NCT00383162|O1|Outcome|Placebo|
1171140|NCT00384033|P2|Participant Flow|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171141|NCT00384033|P1|Participant Flow|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171142|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
1171143|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171144|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171145|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171146|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
1171147|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171148|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171149|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171660|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
1171151|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171152|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171153|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171154|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
1171155|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171156|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171157|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171158|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
1171159|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171160|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171161|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171162|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
1171163|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171164|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171165|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171166|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
1171167|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171168|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171169|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171170|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
1171171|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171217|NCT00383747|P4|Participant Flow|Controls: Placebo (V1) Then Nicotine Patch (V2)|Non-smoking adults without psychiatric illness received placebo patch then nicotine patch 14mg transdermal nicotine application
1171172|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171173|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171174|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
1171175|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171176|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171177|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171178|NCT00384033|E4|Reported Event|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
1171179|NCT00384033|E3|Reported Event|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171180|NCT00384033|E2|Reported Event|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171181|NCT00384033|E1|Reported Event|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
1171182|NCT00383942|B3|Baseline|Total|Total of all reporting groups
1171183|NCT00383942|B2|Baseline|EASI|Patients randomized to this arm receive extra amniotic saline infusion via a catheter that is placed in the uterus
1171184|NCT00383942|B1|Baseline|Misoprostol|Patients randomized to this arm receive 25 micrograms of misoprostol every 4 hours.
1171185|NCT00383942|P2|Participant Flow|EASI|Patients randomized to this arm receive an extra amniotic saline infusion via catheter that is placed in the uterus
1171188|NCT00383942|O1|Outcome|Misoprostol|Patients randomized to this arm receive 25 micrograms of misoprostol every 4 hours.
1171189|NCT00383942|E2|Reported Event|EASI|Patients assigned to this arm received extra amniotic saline infusion via a catheter that is placed in the uterus
1171190|NCT00383942|E1|Reported Event|Misoprostol|Patients assigned to this arm received 25 micrograms of misoprostol every 4 hours
1171191|NCT00383786|B3|Baseline|Total|Total of all reporting groups
1171192|NCT00383786|B2|Baseline|Placebo|sugar pill
1171193|NCT00383786|B1|Baseline|GR205171|selective neurokinin-1 receptor antagonist
1171194|NCT00383786|P2|Participant Flow|Placebo|sugar pill administered daily for a period of 8 weeks
1171195|NCT00383786|P1|Participant Flow|GR205171|selective neurokinin-1 receptor antagonist, 5mg/day for a period of 8 weeks
1171196|NCT00383786|O2|Outcome|Placebo|
1171197|NCT00383786|O1|Outcome|GR205171|
1171198|NCT00383786|E2|Reported Event|Placebo|sugar pill
1171199|NCT00383786|E1|Reported Event|GR205171|selective neurokinin-1 receptor antagonist
1171200|NCT00383760|B1|Baseline|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: 1.4mg/m2 given IV weekly day 1,8 every 21 days (1 cycle)."
1171201|NCT00383760|P1|Participant Flow|E7389|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
1171202|NCT00383760|O1|Outcome|E7389|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
1171203|NCT00383760|O1|Outcome|E7389|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
1171204|NCT00383760|O1|Outcome|E7389|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
1171205|NCT00383760|O1|Outcome|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
1171206|NCT00383760|O1|Outcome|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
1171207|NCT00383760|O1|Outcome|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
1171208|NCT00383760|O1|Outcome|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
1171209|NCT00383760|O1|Outcome|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
1171210|NCT00383760|O1|Outcome|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
1171211|NCT00383760|O1|Outcome|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
1171212|NCT00383760|O1|Outcome|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
1171213|NCT00383760|E1|Reported Event|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
1171214|NCT00383747|B3|Baseline|Total|Total of all reporting groups
1171215|NCT00383747|B2|Baseline|Controls|
1171216|NCT00383747|B1|Baseline|Non Smokers With Schizophrenia|
1171218|NCT00383747|P3|Participant Flow|Controls: Nicotine Patch (V1) Then Placebo (V2)|Non-smoking adults without psychiatric illness received transdermal nicotine patch: 14mg transdermal nicotine application then placebo patch
1171219|NCT00383747|P2|Participant Flow|Nonsmokers w/Schizophr: Placebo (V1) Then Nicotine Patch (V2)|Non smokers with schizophrenia received Placebo patch application then Nicotine patch: 14mg transdermal nicotine
1171220|NCT00383747|P1|Participant Flow|Non-smokers w/Schizophr: Nicotine Patch (V1) Then Placebo (V2)|Nonsmokers with schizophrenia on a stable dose of antipsychotic medication received first transdermal nicotine patch: 14mg transdermal nicotine application then placebo patch
1171221|NCT00383747|O4|Outcome|Control + Placebo|Non-smoking adults without psychiatric illness received placebo patch
1171222|NCT00383747|O3|Outcome|Control + Nicotine Patch|Non-smoking adults without psychiatric illness received transdermal nicotine patch: 14mg transdermal nicotine application
1171223|NCT00383747|O2|Outcome|Nonsmokers With Schizophrenia + Placebo|Non smokers with schizophrenia received Placebo patch application
1171224|NCT00383747|O1|Outcome|Non-smokers With Schizophrenia + Nicotine Patch|Nonsmokers with schizophrenia on a stable dose of antipsychotic medication received first transdermal nicotine patch: 14mg transdermal nicotine application
1171225|NCT00383747|O4|Outcome|Control + Placebo|Non-smoking adults without psychiatric illness received placebo patch
1171226|NCT00383747|O3|Outcome|Control + Nicotine Patch|Non-smoking adults without psychiatric illness received transdermal nicotine patch: 14mg transdermal nicotine application
1171227|NCT00383747|O2|Outcome|Nonsmokers With Schizophrenia + Placebo|Non smokers with schizophrenia received Placebo patch application
1171228|NCT00383747|O1|Outcome|Non-smokers With Schizophrenia + Nicotine Patch|Nonsmokers with schizophrenia on a stable dose of antipsychotic medication received first transdermal nicotine patch: 14mg transdermal nicotine application
1171229|NCT00383747|O4|Outcome|Control + Placebo|Non-smoking adults without psychiatric illness received placebo patch
1171230|NCT00383747|O3|Outcome|Control + Nicotine Patch|Non-smoking adults without psychiatric illness received transdermal nicotine patch: 14mg transdermal nicotine application
1171231|NCT00383747|O2|Outcome|Nonsmokers With Schizophrenia +, Placebo|Non smokers with schizophrenia received Placebo patch application
1171232|NCT00383747|O1|Outcome|Non-smokers With Schizophrenia + Nicotine Patch|Nonsmokers with schizophrenia on a stable dose of antipsychotic medication received first transdermal nicotine patch: 14mg transdermal nicotine application
1171233|NCT00383747|O4|Outcome|Controls + Placebo Nicotine Patch|Non-smoking adults without psychiatric illness + placebo transdermal nicotine patch: 14mg transdermal nicotine application
1171234|NCT00383747|O3|Outcome|Control + Nicotine Patch|Non-smoking adults without psychiatric illness + transdermal nicotine patch: 14mg transdermal nicotine application
1171235|NCT00383747|O2|Outcome|Non Smokers With Schizophrenia + Placebo Nicotine Patch|Non smokers with schizophrenia + Placebo transdermal nicotine patch: 14mg transdermal nicotine application
1171236|NCT00383747|O1|Outcome|Non Smokers With Schizophrenia + Nicotine Patch|Nonsmokers with schizophrenia on a stable dose of antipsychotic medication + transdermal nicotine patch: 14mg transdermal nicotine application
1171242|NCT00383721|B3|Baseline|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
1171243|NCT00383721|B2|Baseline|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
1171244|NCT00383721|B1|Baseline|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
1171245|NCT00383721|P5|Participant Flow|Placebo|Placebo MDI BID for 26 weeks.
1171246|NCT00383721|P4|Participant Flow|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
1171247|NCT00383721|P3|Participant Flow|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
1171248|NCT00383721|P2|Participant Flow|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
1171249|NCT00383721|P1|Participant Flow|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
1171250|NCT00383721|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks.
1171251|NCT00383721|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
1171252|NCT00383721|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
1171253|NCT00383721|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
1171254|NCT00383721|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
1171255|NCT00383721|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks.
1171256|NCT00383721|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
1171257|NCT00383721|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
1171258|NCT00383721|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
1171259|NCT00383721|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
1171260|NCT00383721|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks.
1171261|NCT00383721|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
1171262|NCT00383721|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
1171263|NCT00383721|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
1171264|NCT00383721|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
1171265|NCT00383721|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks.
1171266|NCT00383721|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
1171267|NCT00383721|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
1171268|NCT00383721|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
1171269|NCT00383721|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
1171270|NCT00383721|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks.
1171274|NCT00383721|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
1171275|NCT00383721|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks.
1171276|NCT00383721|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
1171277|NCT00383721|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
1171278|NCT00383721|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
1171279|NCT00383721|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
1171280|NCT00383721|E5|Reported Event|Placebo|Placebo MDI BID for 26 weeks.
1171281|NCT00383721|E4|Reported Event|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
1171282|NCT00383721|E3|Reported Event|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
1171283|NCT00383721|E2|Reported Event|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
1171284|NCT00383721|E1|Reported Event|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
1171285|NCT00383643|B4|Baseline|Total|Total of all reporting groups
1171286|NCT00383643|B3|Baseline|Sodium Oxybate|Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
1171287|NCT00383643|B2|Baseline|Placebo|Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
1171288|NCT00383643|B1|Baseline|Zolpidem Tartrate|Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
1171289|NCT00383643|P3|Participant Flow|Sodium Oxybate|Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
1171290|NCT00383643|P2|Participant Flow|Placebo|Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
1171291|NCT00383643|P1|Participant Flow|Zolpidem Tartrate|Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
1171292|NCT00383643|O3|Outcome|Sodium Oxybate|Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
1171293|NCT00383643|O2|Outcome|Placebo|Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
1171521|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
1171522|NCT00383162|O1|Outcome|Placebo|
1171294|NCT00383643|O1|Outcome|Zolpidem Tartrate|Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
1171295|NCT00383643|O3|Outcome|Sodium Oxybate|Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
1171296|NCT00383643|O2|Outcome|Placebo|Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
1171297|NCT00383643|O1|Outcome|Zolpidem Tartrate|Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
1171298|NCT00383643|O3|Outcome|Sodium Oxybate|Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
1171299|NCT00383643|O2|Outcome|Placebo|Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
1171300|NCT00383643|O1|Outcome|Zolpidem Tartrate|Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
1171301|NCT00383643|O3|Outcome|Sodium Oxybate|Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
1171302|NCT00383643|O2|Outcome|Placebo|Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
1171303|NCT00383643|O1|Outcome|Zolpidem Tartrate|Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
1171304|NCT00383643|O3|Outcome|Sodium Oxybate|Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
1171305|NCT00383643|O2|Outcome|Placebo|Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
1171306|NCT00383643|O1|Outcome|Zolpidem Tartrate|Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
1171307|NCT00383643|E3|Reported Event|Sodium Oxybate|Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
1171308|NCT00383643|E2|Reported Event|Placebo|Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
1171309|NCT00383643|E1|Reported Event|Zolpidem Tartrate|Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
1171310|NCT00383565|B1|Baseline|FR901228|13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
1171311|NCT00383565|P1|Participant Flow|FR901228|13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
1171312|NCT00383565|O1|Outcome|FR901228|13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
1171313|NCT00383565|O1|Outcome|FR901228|13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
1171314|NCT00383565|O1|Outcome|FR901228|13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
1171315|NCT00383565|E1|Reported Event|FR901228|13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
1171316|NCT00383552|B5|Baseline|Total|Total of all reporting groups
1171318|NCT00383552|B3|Baseline|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
1171319|NCT00383552|B2|Baseline|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
1171320|NCT00383552|B1|Baseline|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
1171321|NCT00383552|P4|Participant Flow|Placebo BID|Placebo twice daily (BID)
1171322|NCT00383552|P3|Participant Flow|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
1171323|NCT00383552|P2|Participant Flow|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
1171324|NCT00383552|P1|Participant Flow|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
1171325|NCT00383552|O4|Outcome|Placebo BID|Placebo twice daily (BID)
1171326|NCT00383552|O3|Outcome|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
1171327|NCT00383552|O2|Outcome|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
1171328|NCT00383552|O1|Outcome|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
1171329|NCT00383552|O4|Outcome|Placebo BID|Placebo twice daily (BID)
1171330|NCT00383552|O3|Outcome|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
1171331|NCT00383552|O2|Outcome|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
1171332|NCT00383552|O1|Outcome|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
1171333|NCT00383552|O4|Outcome|Placebo BID|Placebo twice daily (BID)
1171334|NCT00383552|O3|Outcome|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
1171335|NCT00383552|O2|Outcome|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
1171336|NCT00383552|O1|Outcome|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
1171337|NCT00383552|O4|Outcome|Placebo BID|Placebo twice daily (BID)
1171338|NCT00383552|O3|Outcome|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
1171339|NCT00383552|O2|Outcome|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
1171340|NCT00383552|O1|Outcome|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
1171341|NCT00383552|O4|Outcome|Placebo BID|Placebo twice daily (BID)
1171342|NCT00383552|O3|Outcome|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
1171343|NCT00383552|O2|Outcome|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
1171344|NCT00383552|O1|Outcome|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
1171345|NCT00383552|O4|Outcome|Placebo BID|Placebo twice daily (BID).
1171346|NCT00383552|O3|Outcome|F MDI 10 Mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID).
1171347|NCT00383552|O2|Outcome|MF MDI 100 Mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID).
1171348|NCT00383552|O1|Outcome|MF/F MDI 100/10 Mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID).
1171349|NCT00383552|O4|Outcome|Placebo BID|Placebo twice daily (BID)
1171350|NCT00383552|O3|Outcome|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
1171351|NCT00383552|O2|Outcome|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
1171352|NCT00383552|O1|Outcome|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
1171353|NCT00383552|O4|Outcome|Placebo BID|Placebo twice daily (BID)
1171354|NCT00383552|O3|Outcome|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
1171355|NCT00383552|O2|Outcome|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
1171356|NCT00383552|O1|Outcome|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
1171357|NCT00383552|E5|Reported Event|PLACEBO|
1171358|NCT00383552|E4|Reported Event|F MDI 10 MCG BID|
1171359|NCT00383552|E3|Reported Event|MF MDI 100 MCG BID|
1171360|NCT00383552|E2|Reported Event|MF/F MDI 100/10 MCG BID|
1171361|NCT00383552|E1|Reported Event|OL MF MDI 100 MCG BID|Open-label (OL) mometasone furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID). Participants received 2- to 3-weeks (approximately) of open-label run-in with MF MDI 100 mcg BID prior to the 26-week double-blind Treatment Period.
1171362|NCT00383500|B4|Baseline|Total|Total of all reporting groups
1171363|NCT00383500|B3|Baseline|Group III|This is the control group; they will receive no treatment
1171364|NCT00383500|B2|Baseline|Group II|This group of patients will receive prophylactic MLD
1171365|NCT00383500|B1|Baseline|Group I|This group of patients will receive the device.
1171366|NCT00383500|P3|Participant Flow|No Intervention Control|No intervention observational control
1171367|NCT00383500|P2|Participant Flow|Manual Lymphatic Drainage (MLD)|Lymphedema management via self-administered manual lymphatic massage therapy
1171368|NCT00383500|P1|Participant Flow|Flexitouch Device|Lymphedema management via Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)
1171369|NCT00383500|O3|Outcome|No Intervention Control|No intervention observational control
1171370|NCT00383500|O2|Outcome|Manual Lymphatic Drainage (MLD)|Lymphedema management via self-administered manual lymphatic massage therapy
1171371|NCT00383500|O1|Outcome|Flexitouch Device|Lymphedema management via Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)
1171372|NCT00383500|O3|Outcome|No Intervention Control|No intervention observational control
1171373|NCT00383500|O2|Outcome|Manual Lymphatic Drainage (MLD)|Lymphedema management via self-administered manual lymphatic drainage therapy
1171374|NCT00383500|O1|Outcome|Flexitouch Device|Lymphedema management via Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)
1171375|NCT00383500|E3|Reported Event|Observational Control (no Intervention)|Control group, no intervention. No Flexitouch or manual massage therapy
1171376|NCT00383500|E2|Reported Event|Manual Lymphatic Drainage (MLD)|Participants will self-administer lymphedema management via daily manual lymphatic massage therapy, using a Class 1 compression garment.
1171377|NCT00383500|E1|Reported Event|Flexitouch Device|Participants will self-administer lymphedema management via daily use of the Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)
1171378|NCT00383435|B6|Baseline|Total|Total of all reporting groups
1171379|NCT00383435|B5|Baseline|Placebo|Placebo MDI BID for 26 weeks
1171380|NCT00383435|B4|Baseline|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
1171381|NCT00383435|B3|Baseline|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
1171382|NCT00383435|B2|Baseline|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
1171383|NCT00383435|B1|Baseline|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
1171384|NCT00383435|P5|Participant Flow|Placebo|Placebo MDI BID for 26 weeks
1171385|NCT00383435|P4|Participant Flow|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
1171386|NCT00383435|P3|Participant Flow|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
1171387|NCT00383435|P2|Participant Flow|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
1171388|NCT00383435|P1|Participant Flow|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
1171389|NCT00383435|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks
1171390|NCT00383435|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
1171391|NCT00383435|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
1171392|NCT00383435|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
1171393|NCT00383435|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
1171394|NCT00383435|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks
1171395|NCT00383435|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
1171396|NCT00383435|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
1171398|NCT00383435|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
1171399|NCT00383435|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks
1171400|NCT00383435|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
1171401|NCT00383435|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
1171402|NCT00383435|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
1171403|NCT00383435|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
1171404|NCT00383435|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks
1171405|NCT00383435|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
1171406|NCT00383435|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
1171407|NCT00383435|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
1171408|NCT00383435|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
1171409|NCT00383435|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks
1171410|NCT00383435|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
1171411|NCT00383435|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
1171412|NCT00383435|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
1171413|NCT00383435|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
1171414|NCT00383435|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks
1171415|NCT00383435|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
1171416|NCT00383435|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
1171417|NCT00383435|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
1171418|NCT00383435|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
1171419|NCT00383435|E5|Reported Event|PLACEBO|
1171420|NCT00383435|E4|Reported Event|F MDI 10 MCG BID|
1171421|NCT00383435|E3|Reported Event|MF MDI 400 MCG BID|
1171422|NCT00383435|E2|Reported Event|MF/F MDI 400/10 MCG BID|
1171423|NCT00383435|E1|Reported Event|MF/F MDI 200/10 MCG BID|
1171424|NCT00383331|B3|Baseline|Total|Total of all reporting groups
1171425|NCT00383331|B2|Baseline|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
1171426|NCT00383331|B1|Baseline|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
1171427|NCT00383331|P2|Participant Flow|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
1171428|NCT00383331|P1|Participant Flow|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
1171429|NCT00383331|O2|Outcome|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
1171430|NCT00383331|O1|Outcome|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
1171431|NCT00383331|O2|Outcome|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
1171432|NCT00383331|O1|Outcome|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
1171433|NCT00383331|O2|Outcome|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
1171434|NCT00383331|O1|Outcome|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
1171435|NCT00383331|O2|Outcome|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
1171436|NCT00383331|O1|Outcome|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
1171437|NCT00383331|O2|Outcome|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
1171438|NCT00383331|O1|Outcome|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
1171439|NCT00383331|O2|Outcome|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
1171440|NCT00383331|O1|Outcome|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
1171441|NCT00383331|E2|Reported Event|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
1171442|NCT00383331|E1|Reported Event|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
1171443|NCT00383266|B1|Baseline|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m2 IV over 10 minutes~Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle~Each cycle will last 21 days."
1171444|NCT00383266|P1|Participant Flow|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes~Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle~Each cycle will last 21 days."
1171445|NCT00383266|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes~Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle~Each cycle will last 21 days."
1171446|NCT00383266|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes~Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle~Each cycle will last 21 days."
1171447|NCT00383266|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes~Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle~Each cycle will last 21 days."
1171448|NCT00383266|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes~Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle~Each cycle will last 21 days."
1171449|NCT00383266|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes~Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle~Each cycle will last 21 days."
1171450|NCT00383266|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes~Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle~Each cycle will last 21 days."
1171523|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
1171524|NCT00383162|O1|Outcome|Placebo|
1171451|NCT00383266|E1|Reported Event|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes~Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle~Each cycle will last 21 days."
1171452|NCT00383240|B5|Baseline|Total|Total of all reporting groups
1171453|NCT00383240|B4|Baseline|Placebo BID|Placebo MDI BID for 26 weeks
1171454|NCT00383240|B3|Baseline|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
1171455|NCT00383240|B2|Baseline|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
1171456|NCT00383240|B1|Baseline|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
1171457|NCT00383240|P4|Participant Flow|Placebo BID|Placebo MDI BID for 26 weeks
1171458|NCT00383240|P3|Participant Flow|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
1171459|NCT00383240|P2|Participant Flow|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
1171460|NCT00383240|P1|Participant Flow|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
1171461|NCT00383240|O4|Outcome|Placebo BID|Placebo MDI BID for 26 weeks
1171462|NCT00383240|O3|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
1171463|NCT00383240|O2|Outcome|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
1171464|NCT00383240|O1|Outcome|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
1171465|NCT00383240|O4|Outcome|Placebo BID|Placebo MDI BID for 26 weeks
1171466|NCT00383240|O3|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
1171467|NCT00383240|O2|Outcome|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
1171468|NCT00383240|O1|Outcome|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
1171469|NCT00383240|O4|Outcome|Placebo BID|Placebo MDI BID for 26 weeks
1171470|NCT00383240|O3|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
1171471|NCT00383240|O2|Outcome|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
1171472|NCT00383240|O1|Outcome|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
1171473|NCT00383240|O4|Outcome|Placebo BID|Placebo MDI BID for 26 weeks
1171474|NCT00383240|O3|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
1171475|NCT00383240|O2|Outcome|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
1171476|NCT00383240|O1|Outcome|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
1171477|NCT00383240|O4|Outcome|Placebo BID|Placebo MDI BID for 26 weeks
1171478|NCT00383240|O3|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
1171479|NCT00383240|O2|Outcome|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
1171480|NCT00383240|O1|Outcome|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
1171481|NCT00383240|O4|Outcome|Placebo BID|Placebo MDI BID for 26 weeks
1171482|NCT00383240|O3|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
1171483|NCT00383240|O2|Outcome|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
1171484|NCT00383240|O1|Outcome|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
1171485|NCT00383240|E5|Reported Event|PLACEBO|
1171486|NCT00383240|E4|Reported Event|F MDI 10 MCG BID|
1171487|NCT00383240|E3|Reported Event|MF MDI 200 MCG BID|
1171488|NCT00383240|E2|Reported Event|MF/F MDI 200/10 MCG BID|
1171489|NCT00383240|E1|Reported Event|OL MF MDI 200 MCG BID|Participants received 2 to 3 weeks (approximately) of open-label (OL), run-in medication with MF MDI 200 mcg BID prior to the 26-week double-blind treatment period.
1171490|NCT00383162|B1|Baseline|Safety Population|Safety Population – Participants who were randomized and who treated at least 1 migraine attack with investigational product.
1171491|NCT00383162|P2|Participant Flow|Sumatriptan-Naproxen/Placebo|Participants who were randomized to treat the first of two migraine attacks with 85 mg/Naproxen Sodium 500 mg (period 1) and the second attack with Placebo (period 2).
1171492|NCT00383162|P1|Participant Flow|Placebo/Sumatriptan-Naproxen|Participants who were randomized to treat the first of two migraine attacks with Placebo (period 1) and the second attack with 85 mg/Naproxen Sodium 500 mg (period 2).
1171493|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
1171494|NCT00383162|O1|Outcome|Placebo|
1171495|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
1171496|NCT00383162|O1|Outcome|Placebo|
1171497|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
1171498|NCT00383162|O1|Outcome|Placebo|
1171499|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
1171500|NCT00383162|O1|Outcome|Placebo|
1171501|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
1171502|NCT00383162|O1|Outcome|Placebo|
1171503|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
1171504|NCT00383162|O1|Outcome|Placebo|
1171505|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
1171506|NCT00383162|O1|Outcome|Placebo|
1171507|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
1171508|NCT00383162|O1|Outcome|Placebo|
1171509|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
1171510|NCT00383162|O1|Outcome|Placebo|
1171511|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
1171512|NCT00383162|O1|Outcome|Placebo|
1171513|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
1171514|NCT00383162|O1|Outcome|Placebo|
1171515|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
1171516|NCT00383162|O1|Outcome|Placebo|
1171517|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
1171518|NCT00383162|O1|Outcome|Placebo|
1171529|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
1171530|NCT00383162|O1|Outcome|Placebo|
1171531|NCT00383162|E2|Reported Event|Sumatriptan-Naproxen Sodium|Subjects who were randomized to take Sumatriptan 85 mg/Naproxen Sodium 500 mg during Migraine period 1, then a one week wash-out period without any drugs, and then given Placebo during Migraine period 2.
1171532|NCT00383162|E1|Reported Event|Placebo|Subjects who were randomized to take Placebo during Migraine period 1, then a one week wash-out period without any drugs, and then given Sumatriptan 85 mg/Naproxen Sodium 500 mg during Migraine period 2.
1171533|NCT00383149|B1|Baseline|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
1171534|NCT00383149|P1|Participant Flow|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
1171535|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
1171536|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
1171537|NCT00383149|O2|Outcome|Cetuximab|All participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
1171538|NCT00383149|O1|Outcome|Ixabepilone|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks.
1171539|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
1171540|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
1171541|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
1171542|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
1171572|NCT00383123|E1|Reported Event|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
1171573|NCT00383110|B3|Baseline|Total|Total of all reporting groups
1171543|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
1171544|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
1171545|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
1171546|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
1171547|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
1171548|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
1171549|NCT00383149|E1|Reported Event|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
1171550|NCT00383123|B3|Baseline|Total|Total of all reporting groups
1171551|NCT00383123|B2|Baseline|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
1171552|NCT00383123|B1|Baseline|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
1171553|NCT00383123|P2|Participant Flow|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
1171554|NCT00383123|P1|Participant Flow|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
1171555|NCT00383123|O2|Outcome|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
1171556|NCT00383123|O1|Outcome|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
1171557|NCT00383123|O2|Outcome|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
1171558|NCT00383123|O1|Outcome|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
1171559|NCT00383123|O2|Outcome|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
1171560|NCT00383123|O1|Outcome|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
1171561|NCT00383123|O2|Outcome|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
1171562|NCT00383123|O1|Outcome|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
1171563|NCT00383123|O2|Outcome|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
1171564|NCT00383123|O1|Outcome|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
1171565|NCT00383123|O2|Outcome|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
1171566|NCT00383123|O1|Outcome|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
1171567|NCT00383123|O2|Outcome|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
1171568|NCT00383123|O1|Outcome|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
1171569|NCT00383123|O2|Outcome|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
1171570|NCT00383123|O1|Outcome|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
1171571|NCT00383123|E2|Reported Event|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
1171574|NCT00383110|B2|Baseline|Black American Veterans|Black American adult Veterans (age 18 or older) with type 2 diabetes
1171575|NCT00383110|B1|Baseline|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
1171576|NCT00383110|P2|Participant Flow|Black American Veterans|Black American adult Veterans (age 18 or older) with type 2 diabetes
1171577|NCT00383110|P1|Participant Flow|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
1171578|NCT00383110|O2|Outcome|Black American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
1171579|NCT00383110|O1|Outcome|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
1171580|NCT00383110|O2|Outcome|Black American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
1171581|NCT00383110|O1|Outcome|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
1171582|NCT00383110|O2|Outcome|Black American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
1171583|NCT00383110|O1|Outcome|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
1171584|NCT00383110|O2|Outcome|Black American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
1171585|NCT00383110|O1|Outcome|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
1171586|NCT00383110|O2|Outcome|Black American Veterans|Black American adult Veterans (age 18 or older) with type 2 diabetes
1171587|NCT00383110|O1|Outcome|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
1171588|NCT00383110|O2|Outcome|Black American Veterans|Black American adult Veterans (age 18 or older) with type 2 diabetes
1171589|NCT00383110|O1|Outcome|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
1171590|NCT00383110|E2|Reported Event|Black American Veterans|Black American adult Veterans (age 18 or older) with type 2 diabetes
1171591|NCT00383110|E1|Reported Event|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
1171592|NCT00383084|B3|Baseline|Total|Total of all reporting groups
1171593|NCT00383084|B2|Baseline|Education|Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
1171594|NCT00383084|B1|Baseline|Lifestyle Physical Activity|Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group sessions designed to help participants develop and maintain a more physically active lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these sessions.
1171749|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
1171595|NCT00383084|P2|Participant Flow|Education|Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
1171596|NCT00383084|P1|Participant Flow|Lifestyle Physical Activity|Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group sessions designed to help participants develop and maintain a more physically active lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these sessions.
1171597|NCT00383084|O2|Outcome|Education|Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
1171598|NCT00383084|O1|Outcome|Lifestyle Physical Activity|Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group sessions designed to help participants develop and maintain a more physically active lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these sessions.
1171599|NCT00383084|O2|Outcome|Education|Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
1171600|NCT00383084|O1|Outcome|Lifestyle Physical Activity|Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group sessions designed to help participants develop and maintain a more physically active lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these sessions.
1171601|NCT00383084|O2|Outcome|Education|Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
1171602|NCT00383084|O1|Outcome|Lifestyle Physical Activity|Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group sessions designed to help participants develop and maintain a more physically active lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these sessions.
1171603|NCT00383084|O2|Outcome|Education|Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
1171604|NCT00383084|O1|Outcome|Lifestyle Physical Activity|Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group sessions designed to help participants develop and maintain a more physically active lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these sessions.
1171605|NCT00383084|E2|Reported Event|Education|Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
1171606|NCT00383084|E1|Reported Event|Lifestyle Physical Activity|Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group sessions designed to help participants develop and maintain a more physically active lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these sessions.
1171607|NCT00383071|B5|Baseline|Total|Total of all reporting groups
1171608|NCT00383071|B4|Baseline|90 mcg|90 mcg IM every 4 weeks for 4 vaccinations
1171661|NCT00382993|O1|Outcome|Placebo|
1171610|NCT00383071|B2|Baseline|180 mcg|180 mcg IM every 4 weeks for 4 vaccinations
1171611|NCT00383071|B1|Baseline|120 mcg|120 mcg IM every 4 weeks for 4 vaccinations
1171612|NCT00383071|P4|Participant Flow|Cohort 1: 90 mcg|180 mcg every 28 days x 4 doses. Subjects chose vaccination in arm or buttock.
1171613|NCT00383071|P3|Participant Flow|Cohort 4: 180 mcg|120 mcg every 28 days x 2 doses. Subjects randomized to receive vaccination in arm or buttock.
1171614|NCT00383071|P2|Participant Flow|Cohort 3: 180 mcg|180 mcg every 28 days x 4 doses. Subjects chose vaccination in arm or buttock.
1171615|NCT00383071|P1|Participant Flow|Cohort 2: 120 mcg|120 mcg every 28 days x 4 doses. Subjects chose vaccination in arm or buttock.
1171616|NCT00383071|O4|Outcome|180 mcg Cohort 4|120 mcg IM every 4 weeks for 2 vaccinations
1171617|NCT00383071|O3|Outcome|180 mcg|180 mcg IM every 4 weeks for 4 vaccinations
1171618|NCT00383071|O2|Outcome|120 mcg|120 mcg IM every 4 weeks for 4 vaccinations
1171619|NCT00383071|O1|Outcome|90 mcg|90 mcg IM every 4 weeks for 4 vaccinations
1171620|NCT00383071|E4|Reported Event|90 mcg|90 mcg every 28 days x 4 doses
1171621|NCT00383071|E3|Reported Event|180 mcg Cohort 4|180 mcg every 28 days x 2 doses
1171622|NCT00383071|E2|Reported Event|180 mcg|180 mcg every 28 days x 4 doses
1171623|NCT00383071|E1|Reported Event|120 mcg|120 mcg every 28 days x 4 doses
1171624|NCT00383019|B3|Baseline|Total|Total of all reporting groups
1171625|NCT00383019|B2|Baseline|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
1171626|NCT00383019|B1|Baseline|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
1171627|NCT00383019|P2|Participant Flow|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
1171628|NCT00383019|P1|Participant Flow|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
1171629|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
1171630|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
1171631|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
1171750|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
1171632|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
1171633|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
1171634|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
1171635|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
1171636|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
1171637|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
1171638|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
1171639|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
1171640|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
1171641|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
1171642|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
1171643|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
1171644|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
1171645|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
1171646|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
1171647|NCT00383019|E2|Reported Event|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
1171648|NCT00383019|E1|Reported Event|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
1171649|NCT00382993|B1|Baseline|Safety Population|Safety Population – Participants who were randomized and who treated at least 1 migraine attack with investigational product.
1171650|NCT00382993|P2|Participant Flow|Sumatriptan-Naproxen/Placebo|Participants who were randomized to treat the first of two migraine attacks with 85 mg/Naproxen Sodium 500 mg (period 1) and the second attack with Placebo (period 2).
1171651|NCT00382993|P1|Participant Flow|Placebo/Sumatriptan-Naproxen|Participants who were randomized to treat the first of two migraine attacks with Placebo (period 1) and the second attack with 85 mg/Naproxen Sodium 500 mg (period 2).
1171652|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
1171653|NCT00382993|O1|Outcome|Placebo|
1171654|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
1171655|NCT00382993|O1|Outcome|Placebo|
1171656|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
1171657|NCT00382993|O1|Outcome|Placebo|
1171658|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
1171659|NCT00382993|O1|Outcome|Placebo|
1171670|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
1171671|NCT00382993|O1|Outcome|Placebo|
1171672|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
1171673|NCT00382993|O1|Outcome|Placebo|
1171674|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
1171675|NCT00382993|O1|Outcome|Placebo|
1171676|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
1171677|NCT00382993|O1|Outcome|Placebo|
1171678|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
1171679|NCT00382993|O1|Outcome|Placebo|
1171680|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
1171681|NCT00382993|O1|Outcome|Placebo|
1171682|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
1171683|NCT00382993|O1|Outcome|Placebo|
1171684|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
1171685|NCT00382993|O1|Outcome|Placebo|
1171686|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
1171687|NCT00382993|O1|Outcome|Placebo|
1171688|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
1171689|NCT00382993|O1|Outcome|Placebo|
1171690|NCT00382993|E2|Reported Event|Sumatriptan-Naproxen/Placebo|Participants who were randomized to treat the first of two migraine attacks with 85 mg/Naproxen Sodium 500 mg (period 1) and the second attack with Placebo (period 2).
1171691|NCT00382993|E1|Reported Event|Placebo/Sumatriptan-Naproxen|Participants who were randomized to treat the first of two migraine attacks with Placebo (period 1) and the second attack with 85 mg/Naproxen Sodium 500 mg (period 2).
1171692|NCT00382967|B3|Baseline|Total|Total of all reporting groups
1171693|NCT00382967|B2|Baseline|Control Arm|No (Injection) Intervention
1171694|NCT00382967|B1|Baseline|Datscan Product|[Iodine-123]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) [3-5 millicurie (mCi)].
1171695|NCT00382967|P2|Participant Flow|Control Arm|No (Injection) Intervention
1171696|NCT00382967|P1|Participant Flow|Datscan Product|[Iodine-123]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) [3-5 millicurie (mCi)].
1171697|NCT00382967|O2|Outcome|Control Arm|No (Injection) Intervention
1171698|NCT00382967|O1|Outcome|Datscan Product|[Iodine-123]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) [3-5 millicurie (mCi)].
1171699|NCT00382967|O2|Outcome|Control Arm|No (Injection) Intervention
1171700|NCT00382967|O1|Outcome|Datscan Product|[Iodine-123]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) [3-5 millicurie (mCi)].
1171701|NCT00382967|E2|Reported Event|Control Arm|No (Injection) Intervention
1171702|NCT00382967|E1|Reported Event|Datscan Product|[Iodine-123]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) [3-5 millicurie (mCi)].
1171703|NCT00382928|B3|Baseline|Total|Total of all reporting groups
1171704|NCT00382928|B2|Baseline|Experimental: AECD Monitoring + Standard of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
1171705|NCT00382928|B1|Baseline|No Intervention: Standard of Care Group|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
1171706|NCT00382928|P2|Participant Flow|Experimental: AECD Monitoring + Standard of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
1171707|NCT00382928|P1|Participant Flow|No Intervention: Standard of Care Group|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention
1171708|NCT00382928|O2|Outcome|Standard of Care Group|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
1171709|NCT00382928|O1|Outcome|AECD Monitoring + Standard of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
1171710|NCT00382928|O2|Outcome|No Intervention: Standard of Care|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
1171711|NCT00382928|O1|Outcome|Experimental: AECD Monitoring + Standard of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
1171712|NCT00382928|O2|Outcome|Standard of Care|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
1171713|NCT00382928|O1|Outcome|AECD Monitoring + Standard of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
1171714|NCT00382928|O2|Outcome|No Intervention: Standard of Care Group|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
1171715|NCT00382928|O1|Outcome|Experimental: AECD Monitoring + Stand of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
1171716|NCT00382928|E2|Reported Event|No Intervention: Standard of Care Group|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
1171717|NCT00382928|E1|Reported Event|Experimental: AECD Monitoring + Standard of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
1171718|NCT00382863|B3|Baseline|Total|Total of all reporting groups
1171719|NCT00382863|B2|Baseline|Control|Optimal Medical/Device Therapy alone
1171720|NCT00382863|B1|Baseline|Treatment|HeartNet and Optimal Medical/Device Therapy
1171721|NCT00382863|P2|Participant Flow|Control|Optimal Medical/Device Therapy alone
1171722|NCT00382863|P1|Participant Flow|Treatment|HeartNet and Optimal Medical/Device Therapy
1171723|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
1171724|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
1171725|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
1171726|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
1171727|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
1171728|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
1171729|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
1171730|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
1171731|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
1171732|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
1171733|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
1171734|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
1171735|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
1171736|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
1171737|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
1171738|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
1171739|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
1171740|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
1171741|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
1171742|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
1171743|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
1171744|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
1171745|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
1171746|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
1171747|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
1171748|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
1171751|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
1171752|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
1171753|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
1171754|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
1171755|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
1171756|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
1171757|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
1171758|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
1171759|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
1171760|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
1171761|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
1171762|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
1171763|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
1171764|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
1171765|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
1171766|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
1171767|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
1171768|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
1171769|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
1171770|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
1171771|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
1171772|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
1171773|NCT00382863|E2|Reported Event|Control|Optimal Medical/Device Therapy alone
1171774|NCT00382863|E1|Reported Event|Treatment|HeartNet and Optimal Medical/Device Therapy
1171775|NCT00382785|B3|Baseline|Total|Total of all reporting groups
1171776|NCT00382785|B2|Baseline|Non-facilitated (Peer-led)|12-week online support in a peer-led format
1171777|NCT00382785|B1|Baseline|Moderated Group|one 12-week online support group led by a professional healthcare provider
1171778|NCT00382785|P2|Participant Flow|Non-facilitated (Peer-led)|12-week online support in a peer-led format
1171779|NCT00382785|P1|Participant Flow|Moderated Group|one 12-week online support group led by a professional healthcare provider
1171780|NCT00382785|O2|Outcome|Non-facilitated (Peer-led)|12-week online support in a peer-led format
1171781|NCT00382785|O1|Outcome|Moderated Group|one 12-week online support group led by a professional healthcare provider
1171782|NCT00382785|O2|Outcome|Non-facilitated (Peer-led)|12-week online support in a peer-led format
1171783|NCT00382785|O1|Outcome|Moderated Group|one 12-week online support group led by a professional healthcare provider
1171784|NCT00382785|O2|Outcome|Non-facilitated (Peer-led)|12-week online support in a peer-led format
1171785|NCT00382785|O1|Outcome|Moderated Group|one 12-week online support group led by a professional healthcare provider
1171786|NCT00382785|E2|Reported Event|Peer-led|peer-led group
1171787|NCT00382785|E1|Reported Event|Moderated|
1171788|NCT00382733|B1|Baseline|Metronomic Oral Topotecan|All subjects received metronomic oral topotecan daily at the assigned dose level.
1171789|NCT00382733|P5|Participant Flow|Oral Topotecan 1.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.25 mg daily (Dose Level 5).
1171790|NCT00382733|P4|Participant Flow|Oral Topotecan 1.0 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.0 mg daily (Dose Level 4).
1171791|NCT00382733|P3|Participant Flow|Oral Topotecan 0.75 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.75 mg daily (Dose Level 3).
1171792|NCT00382733|P2|Participant Flow|Oral Topotecan 0.50 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.50 mg daily (Dose Level 2).
1171793|NCT00382733|P1|Participant Flow|Oral Topotecan 0.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.25 mg daily (Dose Level 1).
1171865|NCT00382291|B4|Baseline|Total|Total of all reporting groups
1171794|NCT00382733|O5|Outcome|Oral Topotecan 1.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.25 mg daily (Dose Level 5).
1171795|NCT00382733|O4|Outcome|Oral Topotecan 1.0 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.0 mg daily (Dose Level 4).
1171796|NCT00382733|O3|Outcome|Oral Topotecan 0.75 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.75 mg daily (Dose Level 3).
1171797|NCT00382733|O2|Outcome|Oral Topotecan 0.50 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.50 mg daily (Dose Level 2).
1171798|NCT00382733|O1|Outcome|Oral Topotecan 0.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.25 mg daily (Dose Level 1).
1171799|NCT00382733|O5|Outcome|Oral Topotecan 1.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.25 mg daily (Dose Level 5).
1171800|NCT00382733|O4|Outcome|Oral Topotecan 1.0 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.0 mg daily (Dose Level 4).
1171801|NCT00382733|O3|Outcome|Oral Topotecan 0.75 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.75 mg daily (Dose Level 3).
1171802|NCT00382733|O2|Outcome|Oral Topotecan 0.50 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.50 mg daily (Dose Level 2).
1171803|NCT00382733|O1|Outcome|Oral Topotecan 0.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.25 mg daily (Dose Level 1).
1171804|NCT00382733|O1|Outcome|Metronomic Oral Topotecan|All subjects received metronomic oral topotecan daily at the assigned dose level.
1171805|NCT00382733|E5|Reported Event|Oral Topotecan 1.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.25 mg daily (Dose Level 5).
1171806|NCT00382733|E4|Reported Event|Oral Topotecan 1.0 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.0 mg daily (Dose Level 4).
1171836|NCT00382590|E2|Reported Event|Ara-C|Low-Dose Cytarabine (Ara-C) 20 mg twice daily subcutaneously for 10 days.
1171807|NCT00382733|E3|Reported Event|Oral Topotecan 0.75 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.75 mg daily (Dose Level 3).
1171808|NCT00382733|E2|Reported Event|Oral Topotecan 0.50 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.50 mg daily (Dose Level 2).
1171809|NCT00382733|E1|Reported Event|Oral Topotecan 0.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.25 mg daily (Dose Level 1).
1171810|NCT00382720|B4|Baseline|Total|Total of all reporting groups
1171811|NCT00382720|B3|Baseline|(TEX) Taxotere, Eloxatin and Xeloda|Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle.
1171812|NCT00382720|B2|Baseline|(TEF) Taxotere, Eloxatin and 5-fluorouracil|Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle.
1171813|NCT00382720|B1|Baseline|(TE) Taxotere and Eloxatin|Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle.
1171814|NCT00382720|P3|Participant Flow|(TEX) Taxotere, Eloxatin and Xeloda|Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle.
1171815|NCT00382720|P2|Participant Flow|(TEF) Taxotere, Eloxatin and 5-fluorouracil|Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle.
1171816|NCT00382720|P1|Participant Flow|(TE) Taxotere and Eloxatin|Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle.
1171817|NCT00382720|O3|Outcome|(TEX) Taxotere, Eloxatin and Xeloda|Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle.
1171818|NCT00382720|O2|Outcome|(TEF) Taxotere, Eloxatin and 5-fluorouracil|Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle.
1171819|NCT00382720|O1|Outcome|(TE) Taxotere and Eloxatin|Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle.
1171820|NCT00382720|O3|Outcome|(TEX) Taxotere, Eloxatin and Xeloda|Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle.
1171821|NCT00382720|O2|Outcome|(TEF) Taxotere, Eloxatin and 5-fluorouracil|Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle.
1171822|NCT00382720|O1|Outcome|(TE) Taxotere and Eloxatin|Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle.
1171823|NCT00382720|O3|Outcome|(TEX) Taxotere, Eloxatin and Xeloda|Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle.
1171866|NCT00382291|B3|Baseline|Slow Titration|Slow titration of sertraline plus cognitive behavior therapy.
1171824|NCT00382720|O2|Outcome|(TEF) Taxotere, Eloxatin and 5-fluorouracil|Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle.
1171825|NCT00382720|O1|Outcome|(TE) Taxotere and Eloxatin|Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle.
1171826|NCT00382720|E3|Reported Event|(TEX) Taxotere, Eloxatin and Xeloda|Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle.
1171827|NCT00382720|E2|Reported Event|(TEF) Taxotere, Eloxatin and 5-fluorouracil|Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle.
1171828|NCT00382720|E1|Reported Event|(TE) Taxotere and Eloxatin|Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle.
1171829|NCT00382590|B3|Baseline|Total|Total of all reporting groups
1171830|NCT00382590|B2|Baseline|Ara-C|Low-Dose Cytarabine (Ara-C) 20 mg twice daily subcutaneously for 10 days.
1171831|NCT00382590|B1|Baseline|5-Aza + VPA|5-Azacytidine (5-Aza) 75 mg/m^2 subcutaneously daily + Valproic Acid (VPA) 50 mg/m^2 orally daily, each for 7 days
1171832|NCT00382590|P2|Participant Flow|Ara-C|Low-Dose Cytarabine (Ara-C) 20 mg twice daily subcutaneously for 10 days.
1171833|NCT00382590|P1|Participant Flow|5-Aza + VPA|5-Azacytidine (5-Aza) 75 mg/m^2 subcutaneously daily + Valproic Acid (VPA) 50 mg/m^2 orally daily, each for 7 days
1171834|NCT00382590|O2|Outcome|Ara-C|Low-Dose Cytarabine (Ara-C) 20 mg twice daily subcutaneously for 10 days.
1171835|NCT00382590|O1|Outcome|5-Aza + VPA|5-Azacytidine (5-Aza) 75 mg/m^2 subcutaneously daily + Valproic Acid (VPA) 50 mg/m^2 orally daily, each for 7 days
1171837|NCT00382590|E1|Reported Event|5-Aza + VPA|5-Azacytidine (5-Aza) 75 mg/m^2 subcutaneously daily + Valproic Acid (VPA) 50 mg/m^2 orally daily, each for 7 days
1171838|NCT00382408|B3|Baseline|Total|Total of all reporting groups
1171839|NCT00382408|B2|Baseline|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
1171840|NCT00382408|B1|Baseline|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
1171841|NCT00382408|P2|Participant Flow|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
1171842|NCT00382408|P1|Participant Flow|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
1171843|NCT00382408|O2|Outcome|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
1171844|NCT00382408|O1|Outcome|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
1171845|NCT00382408|O2|Outcome|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
1171846|NCT00382408|O1|Outcome|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
1171847|NCT00382408|O2|Outcome|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
1171848|NCT00382408|O1|Outcome|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
1171849|NCT00382408|O2|Outcome|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
1171850|NCT00382408|O1|Outcome|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
1171851|NCT00382408|O2|Outcome|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
1171852|NCT00382408|O1|Outcome|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
1171853|NCT00382408|O2|Outcome|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
1171854|NCT00382408|O1|Outcome|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
1171855|NCT00382408|O2|Outcome|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
1171856|NCT00382408|O1|Outcome|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
1171857|NCT00382408|O2|Outcome|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
1171858|NCT00382408|O1|Outcome|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
1171859|NCT00382408|O2|Outcome|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
1171860|NCT00382408|O1|Outcome|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
1171861|NCT00382408|O2|Outcome|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
1171862|NCT00382408|O1|Outcome|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
1171863|NCT00382408|E2|Reported Event|Vaccine|Participants received a single tablet of both Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
1171864|NCT00382408|E1|Reported Event|Placebo|Participants received a single tablet of both placebos that matched the Type-4 and Type-7 adenovirus vaccines at study visit 1 (Day 0).
1171867|NCT00382291|B2|Baseline|Regular Titration|Regular titration of sertraline plus cognitive behavior therapy.
1171868|NCT00382291|B1|Baseline|Placebo|Placebo plus cognitive behavior therapy.
1171869|NCT00382291|P3|Participant Flow|Slow Sertraline Titration Plus CBT|Slow titration of sertraline (SloSert)plus cognitive behavior therapy. The titration schedule utilized a slower titration schedule relative to the RegSert arm. Unless unable to tolerate higher doses, children remained on 25mg/day for the first two weeks, 50mg/day from weeks 3-4, 75mg/day for weeks 5-6, 100mg/day for week 7, 150mg/day for week 8, and 200mg/day for week 9 until the end of the study.
1171870|NCT00382291|P2|Participant Flow|Regular Sertraline Titration Plus CBT|Regular titration of sertraline (RegSert) plus cognitive behavior therapy. The titration schedule used a flexible upward titration from 25 mg/day to 200 mg/day over 9 weeks unless higher doses were not tolerated, after which the dosage was adjusted as a function of tolerability. If tolerated, maximum dose could be achieved in 5 weeks.
1171871|NCT00382291|P1|Participant Flow|Placebo Plus CBT|Placebo plus cognitive behavior therapy (CBT).
1171872|NCT00382291|O3|Outcome|Slow Titration|Slow titration of sertraline plus cognitive behavior therapy. The titration schedule utilized a slower titration schedule relative to the RegSert arm. Unless unable to tolerate higher doses, children remained on 25mg/day for the first two weeks, 50mg/day from weeks 3-4, 75mg/day for weeks 5-6, 100mg/day for week 7, 150mg/day for week 8, and 200mg/day for week 9 until the end of the study.
1171873|NCT00382291|O2|Outcome|Regular Titration|Regular titration of sertraline plus cognitive behavior therapy. The titration schedule used a flexible upward titration from 25 mg/day to 200 mg/day over 9 weeks unless higher doses were not tolerated, after which the dosage was adjusted as a function of tolerability. If tolerated, maximum dose could be achieved in 5 weeks.
1171874|NCT00382291|O1|Outcome|Placebo|Placebo plus cognitive behavior therapy.
1171875|NCT00382291|O3|Outcome|Slow Titration|Slow titration of sertraline plus cognitive behavior therapy.
1171876|NCT00382291|O2|Outcome|Regular Titration|Regular titration of sertraline plus cognitive behavior therapy.
1171877|NCT00382291|O1|Outcome|Placebo|Placebo plus cognitive behavior therapy.
1171878|NCT00382291|E3|Reported Event|Slow Titration|Slow titration of sertraline plus cognitive behavior therapy.
1171879|NCT00382291|E2|Reported Event|Regular Titration|Regular titration of sertraline plus cognitive behavior therapy.
1171880|NCT00382291|E1|Reported Event|Placebo|Placebo plus cognitive behavior therapy.
1171881|NCT00382174|B3|Baseline|Total|Total of all reporting groups
1171882|NCT00382174|B2|Baseline|Tβ4 at 3 Doses|0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w
1171883|NCT00382174|B1|Baseline|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
1171884|NCT00382174|P3|Participant Flow|Placebo vs. Thymosin Beta 4 at 3 Doses|Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1%
1171885|NCT00382174|P2|Participant Flow|Tβ4 at 3 Doses|0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w
1171886|NCT00382174|P1|Participant Flow|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
1171887|NCT00382174|O3|Outcome|Placebo vs. Thymosin Beta 4 at 3 Doses|Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1%
1171888|NCT00382174|O2|Outcome|Tβ4 at 3 Doses|0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w
1171889|NCT00382174|O1|Outcome|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
1171890|NCT00382174|O3|Outcome|Placebo vs. Thymosin Beta 4 at 3 Doses|Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1%
1171891|NCT00382174|O2|Outcome|Tβ4 at 3 Doses|0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w
1171892|NCT00382174|O1|Outcome|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
1171893|NCT00382174|E3|Reported Event|Placebo vs. Thymosin Beta 4 at 3 Doses|Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1%
1171894|NCT00382174|E2|Reported Event|Tβ4 at 3 Doses|0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w
1171895|NCT00382174|E1|Reported Event|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
1171896|NCT00382148|B3|Baseline|Total|Total of all reporting groups
1171897|NCT00382148|B2|Baseline|Omalizumab (Omalizumab in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
1171898|NCT00382148|B1|Baseline|Omalizumab (Placebo in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
1171899|NCT00382148|P2|Participant Flow|Omalizumab (Omalizumab in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
1171900|NCT00382148|P1|Participant Flow|Omalizumab (Placebo in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
1171901|NCT00382148|O2|Outcome|Omalizumab (Omalizumab in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
1171902|NCT00382148|O1|Outcome|Omalizumab (Placebo in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
1171903|NCT00382148|O2|Outcome|Omalizumab (Omalizumab in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
1171904|NCT00382148|O1|Outcome|Omalizumab (Placebo in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
1171905|NCT00382148|O2|Outcome|Omalizumab (Omalizumab in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
1171906|NCT00382148|O1|Outcome|Omalizumab (Placebo in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
1171907|NCT00382148|O2|Outcome|Omalizumab (Omalizumab in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
1171908|NCT00382148|O1|Outcome|Omalizumab (Placebo in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
1171909|NCT00382148|E2|Reported Event|Omalizumab (Omalizumab in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
1171992|NCT00381849|O2|Outcome|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
1171910|NCT00382148|E1|Reported Event|Omalizumab (Placebo in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
1171911|NCT00382109|B3|Baseline|Total|Total of all reporting groups
1171912|NCT00382109|B2|Baseline|Tacro-MTX GVHD Prophylaxis|Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally (when able) daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors).
1171913|NCT00382109|B1|Baseline|Tacro-MTX/Sirolimus GVHD Prophylaxis Regimen|Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors) and oral sirolimus (dose 2.5mg/m2/day - 4 mg max starting dose) daily starting on day 0 followed by a taper starting on day 180 through day 207.
1171950|NCT00382018|B4|Baseline|Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and >= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs.
1171914|NCT00382109|P2|Participant Flow|Tacro-MTX GVHD Prophylaxis|Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally (when able) daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors).
1171915|NCT00382109|P1|Participant Flow|Tacro-MTX/Sirolimus GVHD Prophylaxis Regimen|Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors) and oral sirolimus (dose 2.5mg/m2/day - 4 mg max starting dose) daily starting on day 0 followed by a taper starting on day 180 through day 207.
1171916|NCT00382109|O2|Outcome|Control|Tacro-MTX GVHD Prophylaxis
1171917|NCT00382109|O1|Outcome|Experiemental|Tacro-MTX/Sirolimus GVHD Prophylaxis
1171918|NCT00382109|O1|Outcome|All Patients|Relative contribution of ALL blasts to the donor immune response as a cause of relapse pre transplantation (MRD)
1171919|NCT00382109|O1|Outcome|All Patients|Relative contribution of ALL blasts to the donor immune response as a cause of relapse post transplantation (correlating development of aGVHD with relapse).
1171920|NCT00382109|O2|Outcome|Control|Tacro-MTX GVHD Prophylaxis
1171921|NCT00382109|O1|Outcome|Experiemental|Tacro-MTX/Sirolimus GVHD Prophylaxis
1171922|NCT00382109|O2|Outcome|Control|Tacro-MTX GVHD Prophylaxis
1171923|NCT00382109|O1|Outcome|Experimental|Tacro-MTX/Sirolimus GVHD Prophylaxis
1171924|NCT00382109|O2|Outcome|Control|Tacro-MTX GVHD Prophylaxis
1171925|NCT00382109|O1|Outcome|Experiemental|Tacro-MTX/Sirolimus GVHD Prophylaxis
1171926|NCT00382109|O2|Outcome|Control|Tacro-MTX GVHD Prophylaxis
1171927|NCT00382109|O1|Outcome|Experimental|Tacro-MTX/Sirolimus GVHD Prophylaxis
1171928|NCT00382109|O2|Outcome|Control|Tacro-MTX GVHD Prophylaxis
1171929|NCT00382109|O1|Outcome|Experimental|Tacro-MTX/Sirolimus GVHD Prophylaxis
1171930|NCT00382109|O2|Outcome|Control|Tacro-MTX GVHD Prophylaxis
1171931|NCT00382109|O1|Outcome|Experimental|Tacro-MTX/Sirolimus GVHD Prophylaxis
1171932|NCT00382109|E2|Reported Event|Tacro-MTX GVHD Prophylaxis|Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally (when able) daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors).
1171966|NCT00382018|O1|Outcome|Arm A (Baseline CTCs < 5, Low Risk)|Patients did not have increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB). Patients would be treated at clinician's discretion. Patients could be enrolled in other trials while being followed. Patients were followed only for overall survival (OS) and progression-free survival (PFS).
1171991|NCT00381849|P1|Participant Flow|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
1171933|NCT00382109|E1|Reported Event|Tacro-MTX/Sirolimus GVHD Prophylaxis Regimen|Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors) and oral sirolimus (dose 2.5mg/m2/day - 4 mg max starting dose) daily starting on day 0 followed by a taper starting on day 180 through day 207.
1171934|NCT00382031|B3|Baseline|Total|Total of all reporting groups
1171935|NCT00382031|B2|Baseline|Control|Best Supportive Care
1171936|NCT00382031|B1|Baseline|Zalutumumab|Zalutumumab in combination with Best Supportive Care
1171937|NCT00382031|P2|Participant Flow|Control|Best Supportive Care
1171938|NCT00382031|P1|Participant Flow|Zalutumumab|Zalutumumab in combination with Best Supportive Care. Patients received weekly infusions of zalutumumab. After a loading dose of 8 mg/kg the dose was reduced to 4 mg/kg and individual dose titration based on skin rash evaluation was performed.
1171939|NCT00382031|O2|Outcome|Control|Best Supportive Care
1171940|NCT00382031|O1|Outcome|Zalutumumab|Zalutumumab in combination with Best Supportive Care
1171941|NCT00382031|O2|Outcome|Control|Best Supportive Care
1171942|NCT00382031|O1|Outcome|Zalutumumab|Zalutumumab in combination with Best Supportive Care
1171943|NCT00382031|O2|Outcome|Control|Best Supportive Care
1171944|NCT00382031|O1|Outcome|Zalutumumab|Zalutumumab in combination with Best Supportive Care
1171945|NCT00382031|O2|Outcome|Control|Best Supportive Care
1171946|NCT00382031|O1|Outcome|Zalutumumab|Zalutumumab in combination with Best Supportive Care
1171947|NCT00382031|E2|Reported Event|Control|Best Supportive Care
1171948|NCT00382031|E1|Reported Event|Zalutumumab|Zalutumumab in combination with Best Supportive Care
1171949|NCT00382018|B5|Baseline|Total|Total of all reporting groups
1172236|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1171951|NCT00382018|B3|Baseline|Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and >= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy.
1171952|NCT00382018|B2|Baseline|Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) but < 5 CTCs at first follow-up (Day 22). Patients would maintain current therapy and will not be randomized.
1171953|NCT00382018|B1|Baseline|Arm A (Baseline CTCs < 5, Low Risk)|Patients did not have increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB). Patients would be treated at clinician's discretion. Patients could be enrolled in other trials while being followed. Patients were followed only for overall survival (OS) and progression-free survival (PFS).
1171954|NCT00382018|P4|Participant Flow|Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and >= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs.
1171955|NCT00382018|P3|Participant Flow|Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and >= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy.
1171956|NCT00382018|P2|Participant Flow|Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) but < 5 CTCs at first follow-up (Day 22). Patients would maintain current therapy and will not be randomized.
1171957|NCT00382018|P1|Participant Flow|Arm A (Baseline CTCs < 5, Low Risk)|Patients did not have increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB). Patients would be treated at clinician's discretion. Patients could be enrolled in other trials while being followed. Patients were followed only for overall survival (OS) and progression-free survival (PFS).
1171958|NCT00382018|O3|Outcome|Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|
1171959|NCT00382018|O2|Outcome|Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|
1171960|NCT00382018|O1|Outcome|Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)|
1171961|NCT00382018|O3|Outcome|Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and >= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy or change therapy to an alternative therapy
1171962|NCT00382018|O2|Outcome|Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) but < 5 CTCs at first follow-up (Day 22). Patients would maintain current therapy and will not be randomized.
1171963|NCT00382018|O1|Outcome|Arm A (Baseline CTCs < 5, Low Risk)|Patients did not have increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB). Patients would be treated at clinician's discretion. Patients could be enrolled in other trials while being followed. Patients were followed only for overall survival (OS) and progression-free survival (PFS).
1171964|NCT00382018|O3|Outcome|Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and >= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy or change therapy to an alternative therapy
1171965|NCT00382018|O2|Outcome|Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) but < 5 CTCs at first follow-up (Day 22). Patients would maintain current therapy and will not be randomized.
1171967|NCT00382018|O2|Outcome|Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and >= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs.
1171968|NCT00382018|O1|Outcome|Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and >= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy.
1171969|NCT00382018|O2|Outcome|Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and >= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs.
1171970|NCT00382018|O1|Outcome|Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and >= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy.
1171971|NCT00382018|E3|Reported Event|Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|
1171972|NCT00382018|E2|Reported Event|Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)|
1171973|NCT00382018|E1|Reported Event|Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk)|
1171974|NCT00381940|B1|Baseline|Treatment (Ifosfamide, Vinorelbine, Bortezomib)|"This was a single arm study that treated all patients with ifosfamide, vinorelbine, and bortezomib. Patients received ifosfamide IV (3000 mg/m2/day) continuously over days 1-4, vinorelbine ditartrate IV (25 mg/m2/dose) over 6-10 minutes on days 1 and 5, bortezomib IV (1.2 mg/m2/dose) on days 1, 4, and 8, and filgrastim (G-CSF) IV or subcutaneously beginning on day 6 and continuing until blood counts recover or PBSC are harvested. Treatment cycle repeats every 21 days for up to 2 or 4 courses in the absence of disease progression or unacceptable toxicity.~Patients undergo autologous PBSC harvesting according to institutional guidelines after the second course of therapy.~ifosfamide: Given IV~bortezomib: Given IV~vinorelbine ditartrate: Given IV~filgrastim: Given IV or SC"
1172009|NCT00381810|P1|Participant Flow|Rituximab 1000 mg|Participants received rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants also received methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion.
1172237|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1171975|NCT00381940|P1|Participant Flow|Treatment (Ifosfamide, Vinorelbine, Bortezomib)|"This was a single arm study that treated all patients with ifosfamide, vinorelbine, and bortezomib. Patients received ifosfamide IV (3000 mg/m2/day) continuously over days 1-4, vinorelbine ditartrate IV (25 mg/m2/dose) over 6-10 minutes on days 1 and 5, bortezomib IV (1.2 mg/m2/dose) on days 1, 4, and 8, and filgrastim (G-CSF) IV or subcutaneously beginning on day 6 and continuing until blood counts recover or PBSC are harvested. Treatment cycle repeats every 21 days for up to 2 or 4 courses in the absence of disease progression or unacceptable toxicity.~Patients undergo autologous PBSC harvesting according to institutional guidelines after the second course of therapy.~ifosfamide: Given IV~bortezomib: Given IV~vinorelbine ditartrate: Given IV~filgrastim: Given IV or SC"
1171976|NCT00381940|O1|Outcome|Treatment (Ifosfamide, Vinorelbine, Bortezomib)|"This was a single arm study that treated all patients with ifosfamide, vinorelbine, and bortezomib. Patients received ifosfamide IV (3000 mg/m2/day) continuously over days 1-4, vinorelbine ditartrate IV (25 mg/m2/dose) over 6-10 minutes on days 1 and 5, bortezomib IV (1.2 mg/m2/dose) on days 1, 4, and 8, and filgrastim (G-CSF) IV or subcutaneously beginning on day 6 and continuing until blood counts recover or PBSC are harvested. Treatment cycle repeats every 21 days for up to 2 or 4 courses in the absence of disease progression or unacceptable toxicity.~Patients undergo autologous PBSC harvesting according to institutional guidelines after the second course of therapy.~ifosfamide: Given IV~bortezomib: Given IV~vinorelbine ditartrate: Given IV~filgrastim: Given IV or SC"
1171977|NCT00381940|E1|Reported Event|Treatment (Ifosfamide, Vinorelbine, Bortezomib)|"This was a single arm study that treated all patients with ifosfamide, vinorelbine, and bortezomib. Patients received ifosfamide IV (3000 mg/m2/day) continuously over days 1-4, vinorelbine ditartrate IV (25 mg/m2/dose) over 6-10 minutes on days 1 and 5, bortezomib IV (1.2 mg/m2/dose) on days 1, 4, and 8, and filgrastim (G-CSF) IV or subcutaneously beginning on day 6 and continuing until blood counts recover or PBSC are harvested. Treatment cycle repeats every 21 days for up to 2 or 4 courses in the absence of disease progression or unacceptable toxicity.~Patients undergo autologous PBSC harvesting according to institutional guidelines after the second course of therapy.~ifosfamide: Given IV~bortezomib: Given IV~vinorelbine ditartrate: Given IV~filgrastim: Given IV or SC"
1171978|NCT00381888|B1|Baseline|Patients Enrolled and Consented|This number includes all patients that were consented and enrolled in the study and received at least one dose of study drug.
1171979|NCT00381888|P1|Participant Flow|Patients Enrolled and Consented|This number includes all patients consented and enrolled in this study.
1171980|NCT00381888|O1|Outcome|Fondaparinux Patients Who Completed Study|This number includes all patients that completed 4 weeks of the study and were treated with 2.5 mg of Fondaparinux on days 1-28.
1171981|NCT00381888|O1|Outcome|Fondaparinux Patients Who Completed Study|This number includes all patients that completed 4 weeks of the study and were treated with 2.5 mg of Fondaparinux on days 1-28.
1171982|NCT00381888|E1|Reported Event|All Patients Who Received at Least One Dose of Fondaparinux|This number includes all patients that received one or more doses of study drug. All events were determined to be unrelated to Fondaparinux.
1171983|NCT00381862|B1|Baseline|Aprepitant and Palonosetron|"Aprepitant: 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle~Palonosetron: 0.25 mg IV push on day 1 only"
1171984|NCT00381862|P1|Participant Flow|Aprepitant and Palonosetron|"Aprepitant: 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle~Palonosetron: 0.25 mg IV push on day 1 only"
1171985|NCT00381862|O1|Outcome|Aprepitant and Palonosetron|"Aprepitant: 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle~Palonosetron: 0.25 mg IV push on day 1 only"
1171986|NCT00381862|E1|Reported Event|Aprepitant and Palonosetron|"Aprepitant: 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle~Palonosetron: 0.25 mg IV push on day 1 only"
1171987|NCT00381849|B3|Baseline|Total|Total of all reporting groups
1171988|NCT00381849|B2|Baseline|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
1171989|NCT00381849|B1|Baseline|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
1171990|NCT00381849|P2|Participant Flow|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
1171993|NCT00381849|O1|Outcome|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
1171994|NCT00381849|O2|Outcome|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
1171995|NCT00381849|O1|Outcome|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
1171996|NCT00381849|O2|Outcome|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
1171997|NCT00381849|O1|Outcome|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
1171998|NCT00381849|O2|Outcome|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
1171999|NCT00381849|O1|Outcome|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
1172000|NCT00381849|O2|Outcome|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
1172001|NCT00381849|O1|Outcome|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
1172002|NCT00381849|O2|Outcome|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
1172003|NCT00381849|O1|Outcome|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
1172004|NCT00381849|O2|Outcome|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
1172005|NCT00381849|O1|Outcome|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
1172006|NCT00381849|E2|Reported Event|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
1172007|NCT00381849|E1|Reported Event|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
1172008|NCT00381810|B1|Baseline|Rituximab 1000 mg|Participants received rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants also received methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion.
1172121|NCT00381680|O2|Outcome|Arm B: Randomized High Dose Vincristine Regimen|Intensive VCR dosing (2 mg/m^2, max 2.5 mg)
1173798|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
1172010|NCT00381810|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants also received methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion.
1172011|NCT00381810|E1|Reported Event|Rituximab 1000 mg|Participants received rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants also received methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion.
1172012|NCT00381797|B6|Baseline|Total|Total of all reporting groups
1172013|NCT00381797|B5|Baseline|Low Grade Glioma|Recurrent low grade glioma (Stratum E): The only patients with recurrent low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172014|NCT00381797|B4|Baseline|Ependymoma|Recurrent or progressive ependymoma (Stratum D):The only patients with recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172015|NCT00381797|B3|Baseline|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C): The only patients with recurrent or progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172016|NCT00381797|B2|Baseline|Brain Stem Tumors|Recurrent,progressive or refractory intrinsic brain stem tumors (Stratum B): The only patients with Recurrent,progressive or refractory intrinsic brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172062|NCT00381797|O3|Outcome|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C):The only patients with recurrent or progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172017|NCT00381797|B1|Baseline|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas (Stratum A): The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172018|NCT00381797|P5|Participant Flow|Low Grade Glioma|Recurrent low grade glioma (Stratum E): The only patients with recurrent low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172019|NCT00381797|P4|Participant Flow|Ependymoma|Recurrent or progressive ependymoma (Stratum D):The only patients with recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172122|NCT00381680|O1|Outcome|Regimen A: Standard Vincristine Dosing|Standard VCR dosing (1.5 mg/m^2, max 2 mg)
1172123|NCT00381680|O1|Outcome|All Patients|This analysis looks at all eligible patients with CC or CT genotypes as well as all eligible patients with the high-risk CEP72 genotype (TT at rs924607).
1172124|NCT00381680|O1|Outcome|Regimen A: Standard Vincristine Dosing|Standard VCR dosing (1.5 mg/m^2, max 2 mg)
1172377|NCT00381303|O2|Outcome|Male|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
1172020|NCT00381797|P3|Participant Flow|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C): The only patients with recurrent or progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172021|NCT00381797|P2|Participant Flow|Brain Stem Tumors|Recurrent,progressive or refractory intrinsic brain stem tumors (Stratum B): The only patients with Recurrent,progressive or refractory intrinsic brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172022|NCT00381797|P1|Participant Flow|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas (Stratum A): The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172023|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B): The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172074|NCT00381706|B4|Baseline|Arm A: Squamous Cell Carcinoma (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
1174135|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
1172024|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172025|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B): The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172026|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172027|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B): The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172238|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172028|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172029|NCT00381797|O5|Outcome|Low Grade Glioma|Recurrent or progressive low grade glioma(Stratum E):The only patients with Recurrent or progressive low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172030|NCT00381797|O4|Outcome|Ependymoma|Recurrent or progressive ependymoma(Stratum D):The only patients with Recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172031|NCT00381797|O3|Outcome|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C):The only patients with recurrent, progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172424|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
1172032|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B): The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172033|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172034|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172035|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172157|NCT00381615|O2|Outcome|Routine+OMV|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine with OMV NZ at 12 months of age.
1172036|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172037|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172038|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors (Stratum B):The only patients with recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172072|NCT00381706|B6|Baseline|Arm C: Squamous Cell Carcinoma (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
1174357|NCT00374907|B3|Baseline|Total|Total of all reporting groups
1172039|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172040|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent,progressive or refractory instrinsic brain stem tumors(Stratum B):The only patients with recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172041|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172042|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172043|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172231|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172044|NCT00381797|O4|Outcome|Low Grade Glioma|Recurrent low grade glioma(Stratum E):The only patients with recurrent low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172045|NCT00381797|O3|Outcome|Ependymoma|Recurrent or progressive ependymoma(Stratum D):The only patients with Recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172046|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172217|NCT00380081|P2|Participant Flow|Placebo/Zolpidem 1.75/Zolpidem 3.5|Cross-over interventions administered in the order listed.
1172047|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172048|NCT00381797|O3|Outcome|Low Grade Glioma|Recurrent or progressive low grade glioma(Stratum E):The only patients with Recurrent or progressive low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172049|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with Recurrent, progressive or refractory Brain Stem Tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172050|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172051|NCT00381797|O4|Outcome|Ependymoma|Recurrent or progressive ependymoma(Stratum D): The only patients with Recurrent, progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172126|NCT00381680|E1|Reported Event|Regimen A: Standard Vincristine Dosing|"See detailed description.~vincristine sulfate: Given IV~prednisone: Given PO~doxorubicin hydrochloride: Given IV~pegaspargase: Given IM~cytarabine: Given IT or IV~methotrexate: Given IT or IV~dexamethasone: Given PO~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV or PO~filgrastim: Given IV or SC~asparaginase: Given IM~mercaptopurine: Given PO"
1172052|NCT00381797|O3|Outcome|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C): The only patients with Recurrent or progressive Medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172053|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172073|NCT00381706|B5|Baseline|Arm B: Squamous Cell Carcinoma (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
1172218|NCT00380081|P1|Participant Flow|Placebo/Zolpidem 3.5/Zolpidem 1.75|Cross-over interventions administered in the order listed.
1172555|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
1172054|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172055|NCT00381797|O5|Outcome|Low Grade Glioma|Recurrent or progressive low grade glioma(Stratum E): The only patients with Recurrent or progressive low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172056|NCT00381797|O4|Outcome|Ependymoma|Recurrent or progressive ependymoma(Stratum D): The only patients with Recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172057|NCT00381797|O3|Outcome|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C):The only patients with Recurrent or progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172058|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172059|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172127|NCT00381628|B5|Baseline|Total|Total of all reporting groups
1172232|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172332|NCT00381303|O7|Outcome|Other|
1172060|NCT00381797|O5|Outcome|Low Grade Glioma|Recurrent or progressive low grade glioma(Stratum E):The only patients with recurrent or progressive low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172061|NCT00381797|O4|Outcome|Ependymoma|Recurrent or progressive ependymoma(Stratum D): The only patients with recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172063|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172064|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A): The only patients with recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172065|NCT00381797|O1|Outcome|Low Grade Glioma|Recurrent low grade glioma (Stratum E): The only patients with recurrent low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172066|NCT00381797|O4|Outcome|Ependymoma|Recurrent or progressive ependymoma (Stratum D):The only patients with recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172067|NCT00381797|O3|Outcome|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C):The only patients with recurrent or progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172125|NCT00381680|E2|Reported Event|Arm B: Randomized High Dose Vincristine Regimen|"See detailed description. Closed to accrual as of 09/2010).~vincristine sulfate: Given IV~prednisone: Given PO~doxorubicin hydrochloride: Given IV~pegaspargase: Given IM~cytarabine: Given IT or IV~methotrexate: Given IT or IV~dexamethasone: Given PO~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV or PO~filgrastim: Given IV or SC~asparaginase: Given IM~mercaptopurine: Given PO"
1172068|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors (Stratum B):The only patients with recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172069|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas (Stratum A): The only patients with recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
1172070|NCT00381797|E1|Reported Event|PBTC-022|Children with recurrent,progressive,or refractory malignant gliomas, diffuse/intrinsic brain stem gliomas, medulloblastomas and low grade gliomas
1172071|NCT00381706|B7|Baseline|Total|Total of all reporting groups
1172165|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
1172422|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
1172075|NCT00381706|B3|Baseline|Arm C: Adenocarcinoma (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
1172076|NCT00381706|B2|Baseline|Arm B: Adenocarcinoma (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
1172077|NCT00381706|B1|Baseline|Arm A: Adenocarcinoma (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
1172078|NCT00381706|P3|Participant Flow|ARM C (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
1172079|NCT00381706|P2|Participant Flow|Arm B (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
1172080|NCT00381706|P1|Participant Flow|Arm A (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
1172333|NCT00381303|O6|Outcome|Asian|
1172081|NCT00381706|O3|Outcome|Arm C: Adenocarcinoma (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
1172082|NCT00381706|O2|Outcome|Arm B: Adenocarcinoma (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
1172083|NCT00381706|O1|Outcome|Arm A: Adenocarcinoma (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
1172084|NCT00381706|O3|Outcome|Arm C: Adenocarcinoma (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
1172085|NCT00381706|O2|Outcome|Arm B: Adenocarcinoma (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
1172086|NCT00381706|O1|Outcome|Arm A: Adenocarcinoma (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
1172166|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
1172087|NCT00381706|O3|Outcome|Arm C: Adenocarcinoma (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
1172088|NCT00381706|O2|Outcome|Arm B: Adenocarcinoma (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
1172089|NCT00381706|O1|Outcome|Arm A: Adenocarcinoma (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
1172090|NCT00381706|O3|Outcome|Arm C: Squamous Cell Carcinoma (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
1172091|NCT00381706|O2|Outcome|Arm B: Squamous Cell Carcinoma (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
1172092|NCT00381706|O1|Outcome|Arm A: Squamous Cell Carcinoma (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
1172156|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines – 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
1172334|NCT00381303|O5|Outcome|Hispanic|
1172093|NCT00381706|O3|Outcome|Arm C: Adenocarcinoma (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
1172094|NCT00381706|O2|Outcome|Arm B: Adenocarcinoma (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
1172095|NCT00381706|O1|Outcome|Arm A: Adenocarcinoma (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
1172096|NCT00381706|E6|Reported Event|Arm C: Squamous Cell Carcinoma (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
1172097|NCT00381706|E5|Reported Event|Arm B: Squamous Cell Carcinoma (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
1172167|NCT00381615|O4|Outcome|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
1172556|NCT00379899|E2|Reported Event|Control Group|
1172557|NCT00379899|E1|Reported Event|Cinacalcet|
1172098|NCT00381706|E4|Reported Event|Arm A: Squamous Cell Carcinoma (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
1172099|NCT00381706|E3|Reported Event|Arm C: Adenocarcinoma (FOLFOX + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m^2 IV over 120 minutes and leucovorin 400 mg/m^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m^2 IV bolus injection, then 5-fluorouracil 2400 mg/m^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
1172100|NCT00381706|E2|Reported Event|Arm B: Adenocarcinoma (IC + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
1172101|NCT00381706|E1|Reported Event|Arm A: Adenocarcinoma (ECF + Cetuximab)|Patients receive cetuximab 400 mg/m^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity.
1172102|NCT00381693|B1|Baseline|Azacitidine|Azacitidine 75 mg/m^2 subcutaneously
1172103|NCT00381693|P1|Participant Flow|Azacitidine|Azacitidine 75 mg/m^2 subcutaneously
1172104|NCT00381693|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2 subcutaneously
1172105|NCT00381693|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2 subcutaneously
1172106|NCT00381693|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2 subcutaneously
1172107|NCT00381693|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2 subcutaneously
1172108|NCT00381693|E1|Reported Event|Azacitidine|Azacitidine 75 mg/m^2 subcutaneously
1172109|NCT00381680|B3|Baseline|Total|Total of all reporting groups
1172110|NCT00381680|B2|Baseline|Arm B: Randomized High Dose Vincristine Regimen|Intensive VCR dosing (2 mg/m^2, max 2.5 mg)
1172111|NCT00381680|B1|Baseline|Regimen A: Standard Vincristine Dosing|Standard VCR dosing (1.5 mg/m^2, max 2 mg)
1172112|NCT00381680|P2|Participant Flow|Regimen B: Randomized High Dose Vincristine Regimen|Intensive VCR dosing (2 mg/m^2, max 2.5 mg)
1172113|NCT00381680|P1|Participant Flow|Regimen A: Standard Vincristine Dosing|Standard VCR dosing (1.5 mg/m^2, max 2 mg)
1172114|NCT00381680|O1|Outcome|Regimen A: Standard Vincristine Dosing|Standard VCR dosing (1.5 mg/m^2, max 2 mg)
1172115|NCT00381680|O2|Outcome|Regimen B|Intensive VCR dosing (2 mg/m^2, max 2.5 mg)
1172116|NCT00381680|O1|Outcome|Regimen A|Standard VCR dosing (1.5 mg/m^2, max 2mg)
1172117|NCT00381680|O2|Outcome|Regimen B|Intensive VCR dosing (2 mg/m^2, max 2.5 mg)
1172118|NCT00381680|O1|Outcome|Regimen A|Standard VCR dosing (1.5 mg/m^2, max 2mg)
1172119|NCT00381680|O2|Outcome|Regimen B|Intensive VCR dosing (2 mg/m^2, max 2.5 mg)
1172120|NCT00381680|O1|Outcome|Regimen A|Standard VCR dosing (1.5 mg/m^2, max 2 mg)
1172335|NCT00381303|O4|Outcome|Caucasian|
1172128|NCT00381628|B4|Baseline|Healthy Volunteers|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the control group~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
1172129|NCT00381628|B3|Baseline|Stable Subjects With Asthma|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the disease control group.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
1172130|NCT00381628|B2|Baseline|Exacerbating Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) at the beginning and end of treatment for a pulmonary exacerbation. These cells will be studied in vitro.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
1172131|NCT00381628|B1|Baseline|Stable Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
1172168|NCT00381615|O3|Outcome|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
1172132|NCT00381628|P4|Participant Flow|Healthy Volunteers|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the control group~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
1172133|NCT00381628|P3|Participant Flow|Stable Subjects With Asthma|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the disease control group.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
1172134|NCT00381628|P2|Participant Flow|Exacerbating Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) at the beginning and end of treatment for a pulmonary exacerbation. These cells will be studied in vitro.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
1172135|NCT00381628|P1|Participant Flow|Stable Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
1172136|NCT00381628|O4|Outcome|Healthy Volunteers|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the control group~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
1172137|NCT00381628|O3|Outcome|Stable Subjects With Asthma|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the disease control group.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
1172138|NCT00381628|O2|Outcome|Exacerbating Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) at the beginning and end of treatment for a pulmonary exacerbation. These cells will be studied in vitro.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
1172233|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172139|NCT00381628|O1|Outcome|Stable Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
1172140|NCT00381628|E4|Reported Event|Healthy Volunteers|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the control group~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
1172141|NCT00381628|E3|Reported Event|Stable Subjects With Asthma|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the disease control group.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
1172142|NCT00381628|E2|Reported Event|Exacerbating Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) at the beginning and end of treatment for a pulmonary exacerbation. These cells will be studied in vitro.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
1172143|NCT00381628|E1|Reported Event|Stable Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
1172144|NCT00381615|B5|Baseline|Total|Total of all reporting groups
1172145|NCT00381615|B4|Baseline|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
1172146|NCT00381615|B3|Baseline|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
1172147|NCT00381615|B2|Baseline|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
1172148|NCT00381615|B1|Baseline|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
1172149|NCT00381615|P4|Participant Flow|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
1172150|NCT00381615|P3|Participant Flow|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
1172151|NCT00381615|P2|Participant Flow|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
1172152|NCT00381615|P1|Participant Flow|rMenB|"Infants received 4 doses of recombinant meningococcal serogroup B (rMenB) vaccine without Outer Membrane Vesicle (OMV-NZ) at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of diphtheria-tetanus-acellular pertussis vaccine (DTaP-Hib-IPV) (at 2, 3, and 4 months) and Heptavalent Pneumococcal Conjugate (PC7) (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and Measles Mumps Rubella (MMR) (at 13 months)."
1172153|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines – 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
1172154|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines – 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
1172155|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines – 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
1172158|NCT00381615|O1|Outcome|Routine|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine without OMV NZ at 12 months of age.
1172159|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines – 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
1172160|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines – 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
1172161|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines – 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
1172162|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines – 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
1172163|NCT00381615|O4|Outcome|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
1172164|NCT00381615|O3|Outcome|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
1172890|NCT00379795|O4|Outcome|Total|All enrolled subjects
1172169|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
1172170|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
1172171|NCT00381615|O4|Outcome|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
1172172|NCT00381615|O3|Outcome|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
1172173|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
1172174|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
1172175|NCT00381615|O4|Outcome|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
1172176|NCT00381615|O3|Outcome|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
1172177|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
1172234|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172336|NCT00381303|O3|Outcome|Black|
1172178|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
1172179|NCT00381615|O4|Outcome|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
1172180|NCT00381615|O3|Outcome|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
1172181|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
1172182|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
1172183|NCT00381615|O2|Outcome|Routine+OMV|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine with OMV NZ at 12 months of age.
1172184|NCT00381615|O1|Outcome|Routine|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine without OMV NZ at 12 months of age.
1172185|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
1172186|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
1172187|NCT00381615|O2|Outcome|Routine+OMV|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine with OMV NZ at 12 months of age.
1172188|NCT00381615|O1|Outcome|Routine|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine without OMV NZ at 12 months of age.
1172189|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
1172190|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
1172191|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
1172192|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
1172193|NCT00381615|O2|Outcome|Routine+OMV|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine with OMV NZ at 12 months of age.
1172194|NCT00381615|O1|Outcome|Routine|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine without OMV NZ at 12 months of age.
1172195|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
1172196|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
1172197|NCT00381615|E4|Reported Event|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
1172235|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172198|NCT00381615|E3|Reported Event|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
1172199|NCT00381615|E2|Reported Event|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
1172200|NCT00381615|E1|Reported Event|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
1172201|NCT00381550|B1|Baseline|Arm I|Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1172202|NCT00381550|P1|Participant Flow|Triapine and Fludarabine Phosphate|Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1172203|NCT00381550|O1|Outcome|Arm I|Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1172204|NCT00381550|O1|Outcome|Arm I|Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1172205|NCT00381550|E1|Reported Event|Arm I|Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1172206|NCT00380081|B7|Baseline|Total|Total of all reporting groups
1172207|NCT00380081|B6|Baseline|Zolpidem 1.75/Zolpidem 3.5/Placebo|Cross-over interventions administered in the order listed.
1172208|NCT00380081|B5|Baseline|Zolpidem 1.75/Placebo/Zolpidem 3.5|Cross-over interventions administered in the order listed.
1172209|NCT00380081|B4|Baseline|Zolpidem 3.5/Zolpidem 1.75/Placebo|Cross-over interventions administered in the order listed.
1172210|NCT00380081|B3|Baseline|Zolpidem 3.5/Placebo/Zolpidem 1.75|Cross-over interventions administered in the order listed.
1172211|NCT00380081|B2|Baseline|Placebo/Zolpidem 1.75/Zolpidem 3.5|Cross-over interventions administered in the order listed.
1172212|NCT00380081|B1|Baseline|Placebo/Zolpidem 3.5/Zolpidem 1.75|Cross-over interventions administered in the order listed.
1172213|NCT00380081|P6|Participant Flow|Zolpidem 1.75/Zolpidem 3.5/Placebo|Cross-over interventions administered in the order listed.
1172214|NCT00380081|P5|Participant Flow|Zolpidem 1.75/Placebo/Zolpidem 3.5|Cross-over interventions administered in the order listed.
1172215|NCT00380081|P4|Participant Flow|Zolpidem 3.5/Zolpidem 1.75/Placebo|Cross-over interventions administered in the order listed.
1172216|NCT00380081|P3|Participant Flow|Zolpidem 3.5/Placebo/Zolpidem 1.75|Cross-over interventions administered in the order listed.
1172219|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172220|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172221|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172222|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172223|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172224|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172225|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172226|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172227|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172228|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172229|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172230|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172337|NCT00381303|O2|Outcome|Male|
1172338|NCT00381303|O1|Outcome|Female|
1172339|NCT00381303|O7|Outcome|Other|
1172239|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172240|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172241|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172242|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172243|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172244|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172245|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172246|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172247|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172248|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172249|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172250|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172251|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172252|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172253|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172254|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172255|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172256|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172257|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172258|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172259|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172260|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172261|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172262|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172263|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172264|NCT00380081|E3|Reported Event|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172265|NCT00380081|E2|Reported Event|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172266|NCT00380081|E1|Reported Event|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
1172267|NCT00380068|B1|Baseline|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
1172268|NCT00380068|P1|Participant Flow|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
1172269|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
1172270|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
1172271|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
1172272|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
1172273|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
1172274|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
1172275|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
1172276|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
1172277|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
1172278|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
1172279|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
1172280|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
1172281|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
1172282|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
1172283|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
1172284|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
1172340|NCT00381303|O6|Outcome|Asian|
1172341|NCT00381303|O5|Outcome|Hispanic|
1172342|NCT00381303|O4|Outcome|Caucasian|
1172343|NCT00381303|O3|Outcome|Black|
1172344|NCT00381303|O2|Outcome|Male|
1172285|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
1172286|NCT00380068|E1|Reported Event|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
1172287|NCT00381485|B4|Baseline|Total|Total of all reporting groups
1172288|NCT00381485|B3|Baseline|MF MDI 400 mcg BID|Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
1172289|NCT00381485|B2|Baseline|MF/F MDI 200/10 mcg BID|Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
1172290|NCT00381485|B1|Baseline|MF/F MDI 400/10 mcg BID|Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
1172291|NCT00381485|P4|Participant Flow|MF MDI 400 mcg BID|Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
1172292|NCT00381485|P3|Participant Flow|MF/F MDI 200/10 mcg BID|Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
1172293|NCT00381485|P2|Participant Flow|MF/F MDI 400/10 mcg BID|Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
1172294|NCT00381485|P1|Participant Flow|Open-Label MF MDI 400 mcg BID|Participants received 2 to 3 weeks (approximately) of open-label, run-in medication with MF MDI 400 mcg BID prior to the 12-week double-blind treatment period.
1172295|NCT00381485|O3|Outcome|MF MDI 400 mcg BID|Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
1172296|NCT00381485|O2|Outcome|MF/F MDI 200/10 mcg BID|Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
1172297|NCT00381485|O1|Outcome|MF/F MDI 400/10 mcg BID|Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
1172298|NCT00381485|O3|Outcome|MF MDI 400 mcg BID|Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
1172299|NCT00381485|O2|Outcome|MF/F MDI 200/10 mcg BID|Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
1172300|NCT00381485|O1|Outcome|MF/F MDI 400/10 mcg BID|Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
1172301|NCT00381485|O3|Outcome|MF MDI 400 mcg BID|Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
1172302|NCT00381485|O2|Outcome|MF/F MDI 200/10 mcg BID|Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
1172303|NCT00381485|O1|Outcome|MF/F MDI 400/10 mcg BID|Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
1172304|NCT00381485|O3|Outcome|MF MDI 400 mcg BID|Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
1172305|NCT00381485|O2|Outcome|MF/F MDI 200/10 mcg BID|Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
1172306|NCT00381485|O1|Outcome|MF/F MDI 400/10 mcg BID|Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
1172307|NCT00381485|E4|Reported Event|Open-Label MF MDI 400 mcg BID|Participants received 2 to 3 weeks (approximately) of open-label, run-in medication with MF MDI 400 mcg BID prior to the 12-week double-blind treatment period.
1172308|NCT00381485|E3|Reported Event|MF MDI 400 mcg BID|Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
1172309|NCT00381485|E2|Reported Event|MF/F MDI 200/10 mcg BID|Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
1172310|NCT00381485|E1|Reported Event|MF/F MDI 400/10 mcg BID|Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
1172311|NCT00381381|B1|Baseline|Donepezil|Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
1172312|NCT00381381|P1|Participant Flow|Donepezil|Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
1172313|NCT00381381|O1|Outcome|Donepezil|Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
1172314|NCT00381381|O1|Outcome|Donepezil|Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
1172315|NCT00381381|O1|Outcome|Donepezil|Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
1172316|NCT00381381|O1|Outcome|Donepezil|Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
1172317|NCT00381381|E1|Reported Event|Donepezil|Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
1172318|NCT00381303|B3|Baseline|Total|Total of all reporting groups
1172319|NCT00381303|B2|Baseline|Male|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
1172320|NCT00381303|B1|Baseline|Female|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
1172321|NCT00381303|P2|Participant Flow|Male|darunavir 600 mg twice bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
1172322|NCT00381303|P1|Participant Flow|Female|darunavir 600 milligram (mg) twice daily dosing (bid) for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
1172323|NCT00381303|O7|Outcome|Other|
1172324|NCT00381303|O6|Outcome|Asian|
1172325|NCT00381303|O5|Outcome|Hispanic|
1172326|NCT00381303|O4|Outcome|Caucasian|
1172327|NCT00381303|O3|Outcome|Black|
1172328|NCT00381303|O2|Outcome|Male|
1172329|NCT00381303|O1|Outcome|Female|
1172330|NCT00381303|O2|Outcome|Male|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
1172331|NCT00381303|O1|Outcome|Female|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
1172378|NCT00381303|O1|Outcome|Female|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
1172379|NCT00381303|E2|Reported Event|Male|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
1172380|NCT00381303|E1|Reported Event|Female|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
1172381|NCT00381238|B1|Baseline|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
1172382|NCT00381238|P1|Participant Flow|RSG XR, 8 mg|The study duration was of 50-week (Wk), which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received Rosiglitazone (RSG) extended release (XR), 4 milligram (mg) tablets once daily (od), orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
1172383|NCT00381238|O1|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
1172384|NCT00381238|O1|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
1172385|NCT00381238|O1|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
1172386|NCT00381238|O1|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
1172387|NCT00381238|O1|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
1172388|NCT00381238|O1|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
1172389|NCT00381238|O1|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
1172423|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
1172390|NCT00381238|O1|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
1172391|NCT00381238|O1|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
1172392|NCT00381238|O1|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
1172393|NCT00381238|O1|Outcome|RSG XR, 8 mg|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
1172394|NCT00381238|E1|Reported Event|RSG XR, 8 MG|The study duration was of 50-Wk, which comprised of a 48-Wk open-label treatment phase and a 2-Wk follow-up phase. During the treatment phase (48-Wk) the eligible participants received RSG XR, 4 mg tablets od, orally in the morning for the first 4 Wks, which was followed by 8 mg od, orally in the morning for further 44 Wks of treatment.
1172395|NCT00381095|B3|Baseline|Total|Total of all reporting groups
1172396|NCT00381095|B2|Baseline|Placebo|Matching placebo capsules orally twice per day
1172397|NCT00381095|B1|Baseline|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
1172398|NCT00381095|P2|Participant Flow|Placebo|Matching placebo capsules orally twice per day
1172399|NCT00381095|P1|Participant Flow|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
1172400|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
1172401|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
1172402|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
1172483|NCT00380874|O2|Outcome|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
1172693|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
1172403|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
1172404|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
1172405|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
1172406|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
1172407|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
1172408|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
1172409|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
1172410|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
1172411|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
1172412|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
1172413|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
1172414|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
1172415|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
1172416|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
1172417|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
1172418|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
1172419|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
1172420|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
1172421|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
1172425|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
1172426|NCT00381095|E2|Reported Event|Placebo|Matching placebo capsules orally twice per day
1172427|NCT00381095|E1|Reported Event|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
1172428|NCT00381043|B3|Baseline|Total|Total of all reporting groups
1172429|NCT00381043|B2|Baseline|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
1172430|NCT00381043|B1|Baseline|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
1172431|NCT00381043|P2|Participant Flow|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
1172432|NCT00381043|P1|Participant Flow|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
1172433|NCT00381043|O2|Outcome|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
1172434|NCT00381043|O1|Outcome|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
1172435|NCT00381043|O2|Outcome|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
1174835|NCT00373113|O1|Outcome|Sunitinib|37.5 mg daily, continuous dosing
1172436|NCT00381043|O1|Outcome|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
1172437|NCT00381043|O2|Outcome|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
1172438|NCT00381043|O1|Outcome|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
1172439|NCT00381043|O2|Outcome|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
1172440|NCT00381043|O1|Outcome|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
1172441|NCT00381043|O2|Outcome|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
1172442|NCT00381043|O1|Outcome|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
1172443|NCT00381043|O2|Outcome|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
1172444|NCT00381043|O1|Outcome|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
1172445|NCT00381043|O2|Outcome|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
1172446|NCT00381043|O1|Outcome|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
1172447|NCT00381043|E2|Reported Event|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
1172448|NCT00381043|E1|Reported Event|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
1172500|NCT00380861|P2|Participant Flow|PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP design in the one knee to the PFC Sigma RP-F design in the other knee.
1172449|NCT00381004|B1|Baseline|FCR + Sargramostim|Fludarabine + Cyclophosphamide + Rituximab (FCR) = Fludarabine - Course 1: 25 mg/m^2 IV Days 2-4; Course 2-6: 25 mg/m^2 IV Days 1-3. Cyclophosphamide - Course 1: 250 mg/m^2 intravenous (IV) Days 2-4; Course 2-6: 250 mg/m^2 Days 1-3. Rituximab - Course 1: 375 mg/m^2 IV over 2-6 hours Day 1; Course 2-6: 500 mg/m^2 IV Day 1. Sargramostim - Course 1: 250 mcg/m^2 subcutaneous (SQ) Days -1 and 5-11; Course 2-6: 250 mcg/m^2 SQ Days -1 and 4-10.
1172450|NCT00381004|P1|Participant Flow|FCR + Sargramostim|Fludarabine + Cyclophosphamide + Rituximab (FCR) = Fludarabine - Course 1: 25 mg/m^2 IV Days 2-4; Course 2-6: 25 mg/m^2 IV Days 1-3. Cyclophosphamide - Course 1: 250 mg/m^2 intravenous (IV) Days 2-4; Course 2-6: 250 mg/m^2 Days 1-3. Rituximab - Course 1: 375 mg/m^2 IV over 2-6 hours Day 1; Course 2-6: 500 mg/m^2 IV Day 1. Sargramostim - Course 1: 250 mcg/m^2 subcutaneous (SQ) Days -1 and 5-11; Course 2-6: 250 mcg/m^2 SQ Days -1 and 4-10.
1172451|NCT00381004|O1|Outcome|FCR + Sargramostim|Fludarabine + Cyclophosphamide + Rituximab (FCR) = Fludarabine - Course 1: 25 mg/m^2 IV Days 2-4; Course 2-6: 25 mg/m^2 IV Days 1-3. Cyclophosphamide - Course 1: 250 mg/m^2 intravenous (IV) Days 2-4; Course 2-6: 250 mg/m^2 Days 1-3. Rituximab - Course 1: 375 mg/m^2 IV over 2-6 hours Day 1; Course 2-6: 500 mg/m^2 IV Day 1. Sargramostim - Course 1: 250 mcg/m^2 subcutaneous (SQ) Days -1 and 5-11; Course 2-6: 250 mcg/m^2 SQ Days -1 and 4-10.
1172452|NCT00381004|O1|Outcome|FCR + Sargramostim|Fludarabine + Cyclophosphamide + Rituximab (FCR) = Fludarabine - Course 1: 25 mg/m^2 IV Days 2-4; Course 2-6: 25 mg/m^2 IV Days 1-3. Cyclophosphamide - Course 1: 250 mg/m^2 intravenous (IV) Days 2-4; Course 2-6: 250 mg/m^2 Days 1-3. Rituximab - Course 1: 375 mg/m^2 IV over 2-6 hours Day 1; Course 2-6: 500 mg/m^2 IV Day 1. Sargramostim - Course 1: 250 mcg/m^2 subcutaneous (SQ) Days -1 and 5-11; Course 2-6: 250 mcg/m^2 SQ Days -1 and 4-10.
1172453|NCT00381004|O1|Outcome|FCR + Sargramostim|Fludarabine + Cyclophosphamide + Rituximab (FCR) = Fludarabine - Course 1: 25 mg/m^2 IV Days 2-4; Course 2-6: 25 mg/m^2 IV Days 1-3. Cyclophosphamide - Course 1: 250 mg/m^2 intravenous (IV) Days 2-4; Course 2-6: 250 mg/m^2 Days 1-3. Rituximab - Course 1: 375 mg/m^2 IV over 2-6 hours Day 1; Course 2-6: 500 mg/m^2 IV Day 1. Sargramostim - Course 1: 250 mcg/m^2 subcutaneous (SQ) Days -1 and 5-11; Course 2-6: 250 mcg/m^2 SQ Days -1 and 4-10.
1172454|NCT00381004|E1|Reported Event|FCR + Sargramostim|Fludarabine + Cyclophosphamide + Rituximab (FCR) = Fludarabine - Course 1: 25 mg/m^2 IV Days 2-4; Course 2-6: 25 mg/m^2 IV Days 1-3. Cyclophosphamide - Course 1: 250 mg/m^2 intravenous (IV) Days 2-4; Course 2-6: 250 mg/m^2 Days 1-3. Rituximab - Course 1: 375 mg/m^2 IV over 2-6 hours Day 1; Course 2-6: 500 mg/m^2 IV Day 1. Sargramostim - Course 1: 250 mcg/m^2 subcutaneous (SQ) Days -1 and 5-11; Course 2-6: 250 mcg/m^2 SQ Days -1 and 4-10.
1172455|NCT00380978|B3|Baseline|Total|Total of all reporting groups
1172456|NCT00380978|B2|Baseline|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
1176855|NCT00368069|O2|Outcome|Placebo|placebo
1172457|NCT00380978|B1|Baseline|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
1172458|NCT00380978|P2|Participant Flow|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
1172459|NCT00380978|P1|Participant Flow|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
1172460|NCT00380978|O2|Outcome|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
1172461|NCT00380978|O1|Outcome|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
1172462|NCT00380978|O2|Outcome|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
1172463|NCT00380978|O1|Outcome|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
1172464|NCT00380978|O2|Outcome|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
1172465|NCT00380978|O1|Outcome|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
1172466|NCT00380978|O2|Outcome|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
1172467|NCT00380978|O1|Outcome|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
1172468|NCT00380978|O2|Outcome|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
1172469|NCT00380978|O1|Outcome|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
1172501|NCT00380861|P1|Participant Flow|PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP-F design in the one knee to the PFC Sigma RP design in the other knee.
1172470|NCT00380978|O2|Outcome|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
1172471|NCT00380978|O1|Outcome|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
1172472|NCT00380978|O2|Outcome|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
1172473|NCT00380978|O1|Outcome|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
1172474|NCT00380978|O2|Outcome|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
1172475|NCT00380978|O1|Outcome|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
1172476|NCT00380978|E2|Reported Event|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
1172477|NCT00380978|E1|Reported Event|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
1172478|NCT00380874|B3|Baseline|Total|Total of all reporting groups
1172479|NCT00380874|B2|Baseline|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
1172480|NCT00380874|B1|Baseline|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
1172481|NCT00380874|P2|Participant Flow|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
1172482|NCT00380874|P1|Participant Flow|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
1172484|NCT00380874|O1|Outcome|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
1172485|NCT00380874|O2|Outcome|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
1172486|NCT00380874|O1|Outcome|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
1172487|NCT00380874|O2|Outcome|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
1172488|NCT00380874|O1|Outcome|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
1172489|NCT00380874|O2|Outcome|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
1172490|NCT00380874|O1|Outcome|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
1172491|NCT00380874|O2|Outcome|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
1172492|NCT00380874|O1|Outcome|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
1172493|NCT00380874|O2|Outcome|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
1172494|NCT00380874|O1|Outcome|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
1172495|NCT00380874|E2|Reported Event|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
1172496|NCT00380874|E1|Reported Event|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
1172497|NCT00380861|B3|Baseline|Total|Total of all reporting groups
1172498|NCT00380861|B2|Baseline|PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP design in the one knee to the PFC Sigma RP-F design in the other knee.
1172499|NCT00380861|B1|Baseline|PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP-F design in the one knee to the PFC Sigma RP design in the other knee.
1172554|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
1172502|NCT00380861|O2|Outcome|PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP design in the one knee to the PFC Sigma RP-F design in the other knee.
1172503|NCT00380861|O1|Outcome|PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP-F design in the one knee to the PFC Sigma RP design in the other knee.
1172504|NCT00380861|E2|Reported Event|PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP design in the one knee to the PFC Sigma RP-F design in the other knee.
1172505|NCT00380861|E1|Reported Event|PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP-F design in the one knee to the PFC Sigma RP design in the other knee.
1172506|NCT00379912|B3|Baseline|Total|Total of all reporting groups
1172507|NCT00379912|B2|Baseline|Arm B Azacitidine|"Azacitidine~Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks."
1172508|NCT00379912|B1|Baseline|Arm A Azacitidine + Erythropoietin|"Azacitidine + Erythropoietin~Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.~Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy"
1172509|NCT00379912|P2|Participant Flow|Arm B Azacitidine|"Azacitidine~Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks."
1172510|NCT00379912|P1|Participant Flow|Arm A Azacitidine + Erythropoietin|"Azacitidine + Erythropoietin~Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.~Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy"
1172511|NCT00379912|O2|Outcome|Non-Responders|Non-Responders
1172512|NCT00379912|O1|Outcome|Responders|Responders
1172513|NCT00379912|O2|Outcome|Non-Responders|Non-Responders
1172514|NCT00379912|O1|Outcome|Responders|Responders
1172515|NCT00379912|O2|Outcome|Non-Responders|Non-Responders
1172516|NCT00379912|O1|Outcome|Responders|Responders
1172517|NCT00379912|O2|Outcome|Arm B Azacitidine|"Azacitidine~Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks."
1172518|NCT00379912|O1|Outcome|Arm A Azacitidine + Erythropoietin|"Azacitidine + Erythropoietin~Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.~Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy"
1172519|NCT00379912|O2|Outcome|Arm B Azacitidine|"Azacitidine~Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks."
1172688|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
1178474|NCT00363168|B3|Baseline|Total|Total of all reporting groups
1172520|NCT00379912|O1|Outcome|Arm A Azacitidine + Erythropoietin|"Azacitidine + Erythropoietin~Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.~Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy"
1172521|NCT00379912|O2|Outcome|Arm A Azacitidine + Erythropoietin|"Azacitidine + Erythropoietin~Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.~Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy"
1172522|NCT00379912|O1|Outcome|Arm B Azacitidine|"Azacitidine~Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks."
1172523|NCT00379912|O2|Outcome|Arm B Azacitidine|"Azacitidine~Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks."
1172524|NCT00379912|O1|Outcome|Arm A Azacitidine + Erythropoietin|"Azacitidine + Erythropoietin~Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.~Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy"
1172525|NCT00379912|E2|Reported Event|Arm B Azacitidine|"Azacitidine~Azacitidine (Monotherapy): Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks."
1172526|NCT00379912|E1|Reported Event|Arm A Azacitidine + Erythropoietin|"Azacitidine + Erythropoietin~Azacitidine: Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.~Erythropoietin: Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy"
1172527|NCT00379899|B3|Baseline|Total|Total of all reporting groups
1172528|NCT00379899|B2|Baseline|Control|Flexible vitamin D dosing
1172529|NCT00379899|B1|Baseline|Cinacalcet|Cinacalcet plus low dose vitamin D
1172530|NCT00379899|P2|Participant Flow|Control|Flexible vitamin D dosing
1172531|NCT00379899|P1|Participant Flow|Cinacalcet|Cinacalcet plus low dose vitamin D
1172532|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
1172533|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
1172534|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
1172535|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
1172536|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
1172537|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
1172538|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
1172539|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
1172540|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
1172541|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
1172542|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
1172543|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
1172544|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
1172545|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
1172546|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
1172547|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
1172548|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
1172549|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
1172550|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
1172551|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
1172552|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
1172553|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
1172558|NCT00380718|B1|Baseline|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
1172559|NCT00380718|P1|Participant Flow|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
1172560|NCT00380718|O1|Outcome|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
1172561|NCT00380718|O1|Outcome|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
1172562|NCT00380718|O1|Outcome|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
1172563|NCT00380718|O1|Outcome|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
1172564|NCT00380718|O1|Outcome|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
1172565|NCT00380718|O1|Outcome|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
1172566|NCT00380718|O1|Outcome|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
1172567|NCT00380718|E1|Reported Event|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
1172568|NCT00380692|B3|Baseline|Total|Total of all reporting groups
1172569|NCT00380692|B2|Baseline|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
1172570|NCT00380692|B1|Baseline|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
1172571|NCT00380692|P2|Participant Flow|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
1172572|NCT00380692|P1|Participant Flow|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
1172573|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
1172574|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
1172575|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
1172576|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
1172577|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
1172578|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
1172579|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
1172580|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
1172581|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
1172582|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
1172583|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
1172584|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
1172585|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
1172586|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
1172587|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
1172588|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
1172589|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
1172590|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
1176492|NCT00369226|B3|Baseline|Total|Total of all reporting groups
1172591|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
1172592|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
1172593|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
1172594|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
1172595|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
1172596|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
1172597|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
1172598|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
1172599|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
1172600|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
1172601|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
1172602|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
1172603|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
1172689|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
1172690|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
1172604|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
1172605|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
1172606|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
1172607|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
1172608|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
1172609|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
1172610|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
1172611|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
1172612|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
1172613|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
1172614|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
1172615|NCT00380692|E2|Reported Event|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
1172616|NCT00380692|E1|Reported Event|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
1172617|NCT00380588|B3|Baseline|Total|Total of all reporting groups
1172618|NCT00380588|B2|Baseline|Gemcitabine|Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
1172619|NCT00380588|B1|Baseline|Gemcitabine + Cisplatin|"Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.~Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal."
1172620|NCT00380588|P2|Participant Flow|Gemcitabine|Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
1172621|NCT00380588|P1|Participant Flow|Gemcitabine + Cisplatin|"Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.~Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal."
1172622|NCT00380588|O2|Outcome|Gemcitabine|Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
1172623|NCT00380588|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.~Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal."
1172624|NCT00380588|O2|Outcome|Gemcitabine|Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
1172625|NCT00380588|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.~Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal."
1172626|NCT00380588|O2|Outcome|Gemcitabine|Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
1172627|NCT00380588|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.~Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal."
1172628|NCT00380588|O2|Outcome|Gemcitabine|Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
1172629|NCT00380588|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.~Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal."
1172630|NCT00380588|E2|Reported Event|Gemcitabine|Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
1172691|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
1172692|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
1172631|NCT00380588|E1|Reported Event|Gemcitabine + Cisplatin|"Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.~Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal."
1172632|NCT00380367|B1|Baseline|Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)|Participants who were enrolled received a total of 3 intramuscular injections of Quadrivalent Human Papilloma Virus (HPV) virus like particles (VLP) vaccine (types 6, 11, 16, 18) given on Day 1, Month 2 and Month 6.
1172633|NCT00380367|P1|Participant Flow|Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)|Participants who were enrolled received a total of 3 intramuscular injections of Quadrivalent Human Papilloma Virus (HPV) virus like particles (VLP) vaccine (types 6, 11, 16, 18) given on Day 1, Month 2 and Month 6.
1172634|NCT00380367|O1|Outcome|Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)|Participants who were enrolled received a total of 3 intramuscular injections of Quadrivalent Human Papilloma Virus (HPV) virus like particles (VLP) vaccine (types 6, 11, 16, 18) given on Day 1, Month 2 and Month 6.
1172635|NCT00380367|O1|Outcome|Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)|Participants who were enrolled received a total of 3 intramuscular injections of Quadrivalent Human Papilloma Virus (HPV) virus like particles (VLP) vaccine (types 6, 11, 16, 18) given on Day 1, Month 2 and Month 6.
1172636|NCT00380367|E1|Reported Event|Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)|Participants who were enrolled received a total of 3 intramuscular injections of Quadrivalent Human Papilloma Virus (HPV) virus like particles (VLP) vaccine (types 6, 11, 16, 18) given on Day 1, Month 2 and Month 6.
1172637|NCT00380250|B3|Baseline|Total|Total of all reporting groups
1172638|NCT00380250|B2|Baseline|Placebo Study Period I|Subjects who received placebo
1172639|NCT00380250|B1|Baseline|Lubiprostone Study Period I|Subjects who received active drug
1172640|NCT00380250|P2|Participant Flow|Placebo Study Period I|Subjects who received placebo
1172641|NCT00380250|P1|Participant Flow|Lubiprostone Study Period I|Subjects who received active drug
1172642|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
1172643|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
1172644|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
1172645|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
1172646|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
1172647|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
1172648|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
1172649|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
1172650|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
1172651|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
1172652|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
1172653|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
1172654|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
1172655|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
1172656|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
1172657|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
1172658|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
1172659|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
1172660|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
1172661|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
1172662|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
1172663|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
1172664|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
1172665|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
1172666|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
1172667|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
1172668|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
1172669|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
1172670|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
1172671|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
1172672|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
1172673|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
1172674|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
1172675|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
1172676|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
1172677|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
1172678|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
1172679|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
1172680|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
1172681|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
1172682|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
1172683|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
1172684|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
1172685|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
1172686|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
1172687|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
1172694|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
1172695|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
1172696|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
1172697|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
1172698|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
1172699|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
1172700|NCT00380250|E2|Reported Event|Placebo Study Period I|Matching placebo capsules twice daily (BID)
1172701|NCT00380250|E1|Reported Event|Lubiprostone Study Period I|8 mcg capsules twice daily (BID)
1172702|NCT00379834|B1|Baseline|Cosopt|Cosopt BID OU
1172703|NCT00379834|P1|Participant Flow|Cosopt|Cosopt BID OU
1172704|NCT00379834|O1|Outcome|Cosopt|Cosopt twice daily in both eyes
1172705|NCT00379834|E1|Reported Event|Cosopt|Cosopt twice daily in both eyes
1172706|NCT00379821|B5|Baseline|Total|Total of all reporting groups
1172707|NCT00379821|B4|Baseline|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172708|NCT00379821|B3|Baseline|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172709|NCT00379821|B2|Baseline|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172710|NCT00379821|B1|Baseline|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1172711|NCT00379821|P4|Participant Flow|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172712|NCT00379821|P3|Participant Flow|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172713|NCT00379821|P2|Participant Flow|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172714|NCT00379821|P1|Participant Flow|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1172715|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172716|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172717|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172718|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1172719|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172720|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1173131|NCT00379353|O2|Outcome|Thalidomide (Day 15)|Thalidomide 100 mg capsules orally, once a day for 14 days.
1172721|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172722|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1172723|NCT00379821|O1|Outcome|All Groups|Participants Receiving Any Treatment in the Study
1172724|NCT00379821|O2|Outcome|Participants Who Did Not Travel and Sleep Outside the City|At enrollment, participants were asked if they travelled and slept outside the city within the previous 4 weeks. This group indicated no.
1172725|NCT00379821|O1|Outcome|Participants Who Traveled and Slept Outside the City|At enrollment, participants were asked if they travelled and slept outside the city within the previous 4 weeks. This group indicated yes.
1172726|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172727|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172728|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172729|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1172730|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172731|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172732|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172733|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1172734|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172735|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172736|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172737|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1172738|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172739|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172740|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172741|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1172742|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172743|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172744|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172745|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1172746|NCT00379821|O1|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172747|NCT00379821|O2|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172748|NCT00379821|O1|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172749|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172750|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172751|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1176493|NCT00369226|B2|Baseline|Phase II|
1172752|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1172753|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172754|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172755|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172756|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1172757|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172758|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172759|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172760|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1172761|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172762|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172763|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172764|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1178795|NCT00362297|E1|Reported Event|Standard Dose|
1172765|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172766|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172767|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172768|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1172769|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172770|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172771|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172772|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1172773|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172774|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172775|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172776|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1172777|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172778|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172779|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172780|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1172781|NCT00379821|O1|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172782|NCT00379821|O2|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1173132|NCT00379353|O1|Outcome|Thalidomide (Baseline)|Thalidomide 100 mg capsules orally, once a day for 14 days.
1172783|NCT00379821|O1|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172784|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172785|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172786|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172787|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1172788|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172789|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172790|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172791|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1172792|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172793|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172794|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172795|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1178796|NCT00362232|B3|Baseline|Total|Total of all reporting groups
1172796|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172797|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172798|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172799|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1172800|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172801|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172802|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172803|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1172804|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172805|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172806|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172807|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1172808|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172809|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172810|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172811|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1172812|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172813|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1173133|NCT00379353|O2|Outcome|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
1173134|NCT00379353|O1|Outcome|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
1172814|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172815|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1172816|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172817|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172818|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172819|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1172820|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172821|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172822|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172823|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1172824|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172825|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172826|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172827|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1179160|NCT00361439|O2|Outcome|Placebo|2 puffs of placebo spray once daily
1172828|NCT00379821|O2|Outcome|CQ Plus Azithromycin|Subjects receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172829|NCT00379821|O1|Outcome|Chloroquine Plus Atovaquone-Proguanil|Subjects receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172830|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172831|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172832|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172833|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1172834|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172835|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172836|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172837|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1172838|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172839|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172840|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172841|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1172842|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172843|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172844|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172845|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1172846|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172847|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172848|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172849|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1172850|NCT00379821|E4|Reported Event|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
1172851|NCT00379821|E3|Reported Event|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
1172852|NCT00379821|E2|Reported Event|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
1172853|NCT00379821|E1|Reported Event|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
1172854|NCT00379808|B1|Baseline|All Participants|Patients were randomized in a crossover design, but baseline characteristics were presented for all participants. Likewise data are not separated by order of treatment because there were no order effects
1172855|NCT00379808|P2|Participant Flow|Montelukast Then Placebo|Patients were randomized in a crossover design to placebo or montelukast. Patients in this arm got montelukast for 4 weeks and then placebo for 4 weeks. There was no washout period
1172856|NCT00379808|P1|Participant Flow|Placebo Then Montelukast|Patients were randomized in a crossover design to placebo or montelukast. Patients int this randomization arm received 4 weeks of placebo then 4 weeks of montelukast. There was no washout between crossover
1172857|NCT00379808|O2|Outcome|Montelukast|This is all patients who received montelukast, whether in the first or second intervention period
1172858|NCT00379808|O1|Outcome|Placebo|This is all participants who received placebo, whether in first or second intervention
1172859|NCT00379808|O2|Outcome|Montelukast|This is all patients who received montelukast, whether in the first or second intervention period
1179269|NCT00361257|B1|Baseline|Minocycline|100 mg orally every 12 hours
1172860|NCT00379808|O1|Outcome|Placebo|This is all participants who received placebo, whether in first or second intervention
1172861|NCT00379808|O2|Outcome|Montelukast|This is all patients who received montelukast, whether in the first or second intervention period
1172862|NCT00379808|O1|Outcome|Placebo|This is all participants who received placebo, whether in first or second intervention
1172863|NCT00379808|O2|Outcome|Montelukast|This is all patients who received montelukast, whether in the first or second intervention period
1172864|NCT00379808|O1|Outcome|Placebo|This is all participants who received placebo, whether in first or second intervention
1172865|NCT00379808|O2|Outcome|Montelukast|This is all patients who received montelukast, whether in the first or second intervention period
1172866|NCT00379808|O1|Outcome|Placebo|This is all participants who received placebo, whether in first or second intervention
1172867|NCT00379808|O2|Outcome|Montelukast|This is all patients who received montelukast, whether in the first or second intervention period
1172868|NCT00379808|O1|Outcome|Placebo|This is all participants who received placebo, whether in first or second intervention
1172869|NCT00379808|E2|Reported Event|Montelukast|This is all patients who received montelukast, whether in the first or second intervention period
1172870|NCT00379808|E1|Reported Event|Placebo|This is all participants who received placebo, whether in first or second intervention
1172871|NCT00379795|B6|Baseline|Total|Total of all reporting groups
1172872|NCT00379795|B5|Baseline|Ranibizumab Untreated Group|In this extension study participants did not receive Ranibizumab. Participants in this group were previously enrolled in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594), FVF2598g (NCT0056823) but did not receive treatment with Ranibizumab in that study or in this extension study (FVF3426g).
1172873|NCT00379795|B4|Baseline|Ranibizumab Treated PDT XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in study FVF2428g or study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injections in previous studies FVF2428g, study FVF2587g or this extension study.
1172874|NCT00379795|B3|Baseline|RanibizumabTreated Sham XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5mg intravitreal injections in previous study FVF2598g or in this extension study.
1172875|NCT00379795|B2|Baseline|RanibizumabTreated Initial + PDT|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injections in combination with photodynamic therapy in Study FVF2428g.
1173135|NCT00379353|O2|Outcome|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
1172876|NCT00379795|B1|Baseline|RanibizumabTreated Initial Mono|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group received ranibizumab 0.5 mg monotherapy, that is, ranibizumab alone in study FVF2598g or ranibizumab in combination with sham photodynamic therapy (PDT) in study FVF2587g.
1172877|NCT00379795|P5|Participant Flow|Ranibizumab Untreated Group|In this extension study participants did not receive Ranibizumab. Participants in this group were enrolled in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) FVF2598g (NCT0056823) but did not receive Ranibizumab intravitreal injections in that study or in this extension study (FVF3426g).
1172878|NCT00379795|P4|Participant Flow|Ranibizumab Treated PDT XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in study FVF2428g or study FVF2587g before crossing over to receive ranibizumab intravitreal injections in study FVF2428g, study FVF2587g or this study.
1172879|NCT00379795|P3|Participant Flow|RanibizumabTreated Sham XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab intravitreal injections in study FVF2598g or this extension study.
1172880|NCT00379795|P2|Participant Flow|RanibizumabTreated Initial + PDT|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab in combination with photodynamic therapy in Study FVF2428g
1172881|NCT00379795|P1|Participant Flow|RanibizumabTreated Initial Mono|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group received ranibizumab monotherapy (Mono) in previous studies, that is, ranibizumab alone in study FVF2598g or ranibizumab in combination with sham photodynamic therapy (PDT) in study FVF2587g.
1173098|NCT00379639|E2|Reported Event|Dose Level 2|Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
1173584|NCT00377832|O1|Outcome|In Labor With a Fever Will Give no Medication|
1172882|NCT00379795|O4|Outcome|Ranibizumab Treated PDT XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in previous study FVF2428g or previous study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g, previous study FVF2587g or this extension study.
1172883|NCT00379795|O3|Outcome|Ranibizumab Treated Sham XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2598g or this extension study.
1172884|NCT00379795|O2|Outcome|Ranibizumab Treated Initial + PDT|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g.
1172885|NCT00379795|O1|Outcome|Ranibizumab Treated Initial Mono|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.
1172886|NCT00379795|O4|Outcome|Total|All enrolled subjects
1172887|NCT00379795|O3|Outcome|Ranibizumab Untreated Group|In this extension study participants did not receive Ranibizumab. Participants in this group were enrolled in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) or FVF2598g (NCT0056823) but did not receive treatment with Ranibizumab in that study or this extension study.
1172888|NCT00379795|O2|Outcome|Ranibizumab Crossover Group|In this extension study participants received Ranibizumab injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group were enrolled but did not initially receive Ranibizumab in Study FVF2428g (NCT00056823), Study FVF2587g (NCT00061594) or Study FVF2598g (NCT00056836) and then crossed over to receive Ranibizumab either in the initial study or this extension study.
1172889|NCT00379795|O1|Outcome|Ranibizumab Initial Group|In this extension study participants received Ranibizumab injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group were initially enrolled and received treatment with Ranibizumab in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) or FVF2598g (NCT0056823).
1172891|NCT00379795|O3|Outcome|Ranibizumab Untreated Group|In this extension study participants did not receive Ranibizumab. Participants in this group were enrolled in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) or FVF2598g (NCT0056823) but did not receive treatment with Ranibizumab in that study or this extension study.
1172892|NCT00379795|O2|Outcome|Ranibizumab Crossover Group|In this extension study participants received Ranibizumab injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group were enrolled but did not initially receive Ranibizumab in Study FVF2428g (NCT00056823), Study FVF2587g (NCT00061594) or Study FVF2598g (NCT00056836) and then crossed over to receive Ranibizumab either in that initial study or this extension study.
1172893|NCT00379795|O1|Outcome|Ranibizumab Initial Group|In this extension study participants received Ranibizumab injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group were initially enrolled and received treatment with Ranibizumab in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) or FVF2598g (NCT0056823).
1172894|NCT00379795|O4|Outcome|Ranibizumab Treated PDT XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in previous study FVF2428g or previous study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g, previous study FVF2587g or this extension study.
1172895|NCT00379795|O3|Outcome|Ranibizumab Treated Sham XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2598g or this extension study.
1172896|NCT00379795|O2|Outcome|Ranibizumab Treated Initial + PDT|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g.
1172932|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
1172897|NCT00379795|O1|Outcome|Ranibizumab Treated Initial Mono|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.
1172898|NCT00379795|O4|Outcome|Ranibizumab Treated PDT XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in previous study FVF2428g or previous study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g, previous study FVF2587g or this extension study.
1172899|NCT00379795|O3|Outcome|Ranibizumab Treated Sham XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2598g or this extension study.
1172900|NCT00379795|O2|Outcome|Ranibizumab Treated Initial + PDT|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g.
1172901|NCT00379795|O1|Outcome|Ranibizumab Treated Initial Mono|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.
1172902|NCT00379795|E4|Reported Event|Ranibizumab Treated PDT XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in previous study FVF2428g or previous study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g, previous study FVF2587g or this extension study.
1173136|NCT00379353|O1|Outcome|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
1172903|NCT00379795|E3|Reported Event|Ranibizumab Treated Sham XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g or this extension study.
1172904|NCT00379795|E2|Reported Event|Ranibizumab Treated Initial + PDT|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g.
1172905|NCT00379795|E1|Reported Event|Ranibizumab Treated Initial Mono|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.
1172906|NCT00379769|B5|Baseline|Total|Total of all reporting groups
1172907|NCT00379769|B4|Baseline|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172908|NCT00379769|B3|Baseline|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172909|NCT00379769|B2|Baseline|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172910|NCT00379769|B1|Baseline|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173099|NCT00379639|E1|Reported Event|Dose Level 1|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
1179569|NCT00360529|B1|Baseline|Placebo|placebo at bedtime
1172911|NCT00379769|P6|Participant Flow|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
1172912|NCT00379769|P5|Participant Flow|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
1172913|NCT00379769|P4|Participant Flow|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172914|NCT00379769|P3|Participant Flow|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172915|NCT00379769|P2|Participant Flow|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172916|NCT00379769|P1|Participant Flow|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172917|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
1172918|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
1172919|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
1172920|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
1173137|NCT00379353|O2|Outcome|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
1173138|NCT00379353|O1|Outcome|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
1172921|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
1172922|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
1172923|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
1172924|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
1172925|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
1172926|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
1172927|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
1172928|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
1172929|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
1172930|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
1172931|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
1180035|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1172933|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
1172934|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
1172935|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
1172936|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
1172937|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
1172938|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
1172939|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
1172940|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
1172941|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
1172942|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
1173139|NCT00379353|O2|Outcome|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
1176494|NCT00369226|B1|Baseline|Phase I|
1172943|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
1172944|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
1172945|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
1172946|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
1172947|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
1172948|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
1172949|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
1172950|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
1172951|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
1172952|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
1172953|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
1173100|NCT00379587|B1|Baseline|Rituxan (Rituximab)|375mg/m^2 IV at 3, 6, 9 and 12 months from transplantation
1173101|NCT00379587|P1|Participant Flow|Rituxan (Rituximab)|375mg/m^2 IV at 3, 6, 9 and 12 months from transplantation
1172954|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
1172955|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
1172956|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
1172957|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172958|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
1172959|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172960|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
1172974|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
1172961|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172962|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
1172963|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172964|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
1172965|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172966|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
1172967|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172968|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
1173102|NCT00379587|O1|Outcome|Rituxan (Rituximab)|375mg/m^2 IV at 3, 6, 9 and 12 months from transplantation
1173103|NCT00379587|O1|Outcome|Rituxan (Rituximab)|375mg/m^2 IV at 3, 6, 9 and 12 months from transplantation
1172969|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172970|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
1172971|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172972|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
1172973|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172975|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172976|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172977|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15mg per day or miconizied equivalent of 10.5mg per day; gliclazide 240mg per day and glimepiride 4mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172978|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172979|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172980|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172981|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15mg per day or miconizied equivalent of 10.5mg per day; gliclazide 240mg per day and glimepiride 4mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172982|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172983|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172984|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172985|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15mg per day or miconizied equivalent of 10.5mg per day; gliclazide 240mg per day and glimepiride 4mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173104|NCT00379587|O1|Outcome|Rituxan (Rituximab)|375mg/m^2 IV at 3, 6, 9 and 12 months from transplantation
1173105|NCT00379587|O1|Outcome|Rituxan (Rituximab)|375mg/m^2 IV at 3, 6, 9 and 12 months from transplantation
1172986|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172987|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172988|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172989|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15mg per day or miconizied equivalent of 10.5mg per day; gliclazide 240mg per day and glimepiride 4mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172990|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172991|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172992|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172993|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15mg per day or miconizied equivalent of 10.5mg per day; gliclazide 240mg per day and glimepiride 4mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172994|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173127|NCT00379353|O6|Outcome|Placebo (Day 29)|Two placebo capsules orally, once a day for 14 days.
1172995|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172996|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172997|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or miconizied equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172998|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1172999|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173000|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173001|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or miconizied equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173002|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173003|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173004|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173005|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173006|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173007|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173008|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173009|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173010|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173011|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173012|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173013|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173128|NCT00379353|O5|Outcome|Placebo (Day 15)|Two placebo capsules orally, once a day for 14 days.
1173129|NCT00379353|O4|Outcome|Placebo (Baseline)|Two placebo capsules orally, once a day for 14 days.
1176495|NCT00369226|P2|Participant Flow|Phase II (45 Days)|
1173014|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173015|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173016|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173017|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173018|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173019|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173020|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173021|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173022|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173023|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173024|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173044|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173025|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173026|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173027|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173028|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173029|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173030|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173031|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173032|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173033|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173034|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173035|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173036|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173037|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173038|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173039|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173040|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173041|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173042|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173043|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173095|NCT00379639|E5|Reported Event|Dose Level 8|Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
1173045|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173046|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173047|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173048|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173049|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173050|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173051|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173052|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173053|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173054|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173055|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173056|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173057|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173058|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173059|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173060|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173096|NCT00379639|E4|Reported Event|Dose Level 6|Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days.
1173097|NCT00379639|E3|Reported Event|Dose Level 5|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
1173585|NCT00377832|O2|Outcome|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
1173061|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173062|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173063|NCT00379769|E6|Reported Event|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
1173064|NCT00379769|E5|Reported Event|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
1173065|NCT00379769|E4|Reported Event|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173066|NCT00379769|E3|Reported Event|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173067|NCT00379769|E2|Reported Event|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173130|NCT00379353|O3|Outcome|Thalidomide (Day 29)|Thalidomide 100 mg capsules orally, once a day for 14 days.
1173068|NCT00379769|E1|Reported Event|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
1173069|NCT00379639|B6|Baseline|Total|Total of all reporting groups
1173070|NCT00379639|B5|Baseline|Dose Level 8|Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
1173071|NCT00379639|B4|Baseline|Dose Level 6|Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days.
1173072|NCT00379639|B3|Baseline|Dose Level 5|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
1173073|NCT00379639|B2|Baseline|Dose Level 2|Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
1173074|NCT00379639|B1|Baseline|Dose Level 1|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
1173075|NCT00379639|P5|Participant Flow|Dose Level 8|Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
1173076|NCT00379639|P4|Participant Flow|Dose Level 6|Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days.
1173077|NCT00379639|P3|Participant Flow|Dose Level 5|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
1173078|NCT00379639|P2|Participant Flow|Dose Level 2|Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
1173079|NCT00379639|P1|Participant Flow|Dose Level 1|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
1173080|NCT00379639|O5|Outcome|Dose Level 8|Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
1173081|NCT00379639|O4|Outcome|Dose Level 6|Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days.
1173082|NCT00379639|O3|Outcome|Dose Level 5|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
1173083|NCT00379639|O2|Outcome|Dose Level 2|Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
1173084|NCT00379639|O1|Outcome|Dose Level 1|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
1173085|NCT00379639|O5|Outcome|Dose Level 8|Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
1173086|NCT00379639|O4|Outcome|Dose Level 6|Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days.
1173087|NCT00379639|O3|Outcome|Dose Level 5|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
1173088|NCT00379639|O2|Outcome|Dose Level 2|Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
1173089|NCT00379639|O1|Outcome|Dose Level 1|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
1173090|NCT00379639|O5|Outcome|Dose Level 8|Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
1173091|NCT00379639|O4|Outcome|Dose Level 6|Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days.
1173092|NCT00379639|O3|Outcome|Dose Level 5|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
1173093|NCT00379639|O2|Outcome|Dose Level 2|Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
1173094|NCT00379639|O1|Outcome|Dose Level 1|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
1173106|NCT00379587|E1|Reported Event|Rituxan (Rituximab)|375mg/m^2 IV at 3, 6, 9 and 12 months from transplantation
1173107|NCT00379574|B1|Baseline|Bortezomib + CHOP Every 2 Weeks|CHOP; cyclophosphamide, doxorubicin, vincristine, and prednisone
1173108|NCT00379574|P1|Participant Flow|Bortezomib + CHOP Every 2 Weeks|"Phase I Bortezomib 1.0, 1/3, and 1.6 mg/m2 CHOP,every 2 weeks cyclophosphamide 750 mg/m2 D1 doxorubicin 50 mg/m2 D1 vincristine 1.4 mg/m2 D1 prednisone 100 mg D1-D5~Phase II Bortezomib 1.6 mg/m2 CHOP,every 2 weeks cyclophosphamide 750 mg/m2 D1 doxorubicin 50 mg/m2 D1 vincristine 1.4 mg/m2 D1 prednisone 100 mg D1-D5"
1173109|NCT00379574|O1|Outcome|Bortezomib + CHOP Every 2 Weeks|CHOP; cyclophosphamide, doxorubicin, vincristine, and prednisone
1173110|NCT00379574|O1|Outcome|Bortezomib + CHOP Every 2 Weeks|CHOP; cyclophosphamide, doxorubicin, vincristine, and prednisone
1173111|NCT00379574|E1|Reported Event|Bortezomib + CHOP Every 2 Weeks|CHOP; cyclophosphamide, doxorubicin, vincristine, and prednisone
1173112|NCT00379353|B3|Baseline|Total|Total of all reporting groups
1173113|NCT00379353|B2|Baseline|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
1173114|NCT00379353|B1|Baseline|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
1173115|NCT00379353|P2|Participant Flow|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
1173116|NCT00379353|P1|Participant Flow|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
1173117|NCT00379353|O4|Outcome|Placebo (Day 15)|Two placebo capsules orally, once a day for 14 days.
1173118|NCT00379353|O3|Outcome|Placebo (Baseline)|Two placebo capsules orally, once a day for 14 days.
1173119|NCT00379353|O2|Outcome|Thalidomide (Day 15)|Thalidomide 100 mg capsules orally, once a day for 14 days
1173120|NCT00379353|O1|Outcome|Thalidomide (Baseline)|Thalidomide 100 mg capsules orally, once a day for 14 days
1173121|NCT00379353|O6|Outcome|Placebo (Day 29)|Two placebo capsules orally, once a day for 14 days.
1173122|NCT00379353|O5|Outcome|Placebo (Day 15)|Two placebo capsules orally, once a day for 14 days.
1173123|NCT00379353|O4|Outcome|Placebo (Baseline)|Two placebo capsules orally, once a day for 14 days.
1173124|NCT00379353|O3|Outcome|Thalidomide (Day 29)|Thalidomide 100 mg capsules orally, once a day for 14 days.
1173125|NCT00379353|O2|Outcome|Thalidomide (Day 15)|Thalidomide 100 mg capsules orally, once a day for 14 days.
1173126|NCT00379353|O1|Outcome|Thalidomide (Baseline)|Thalidomide 100 mg capsules orally, once a day for 14 days.
1173140|NCT00379353|O1|Outcome|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
1173141|NCT00379353|O2|Outcome|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
1173142|NCT00379353|O1|Outcome|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
1173143|NCT00379353|E2|Reported Event|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
1173144|NCT00379353|E1|Reported Event|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
1173145|NCT00379340|B6|Baseline|Total|Total of all reporting groups
1173146|NCT00379340|B5|Baseline|Stage IV With Lung Metastases|Stage IV with lung metastases treated with DD4A for less than 6 weeks and/or response inevaluable at week 6.
1173147|NCT00379340|B4|Baseline|Stage IV With Non-lung Disease Treated With Regimen M|Stage IV with non-lung disease treated with Regimen M.
1173148|NCT00379340|B3|Baseline|Stage III/IV With LOH 1p and 16q Treated With Regimen M|Stage III/IV with LOH 1p and 16q treated with Regimen M.
1173149|NCT00379340|B2|Baseline|Stage IV and Slow Incomplete Response (SIR) of Lung Metastases|Stage IV and slow incomplete response (SIR) of lung metastases treated with Regimen M after 6 weeks of DD4A.
1173150|NCT00379340|B1|Baseline|Stage IV and Rapid Complete Response (RCR) of Lung Metastases|Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A.
1173151|NCT00379340|P5|Participant Flow|Stage IV With Lung Metastases|Stage IV with lung metastases treated with DD4A for less than 6 weeks and/or response inevaluable at week 6.
1173152|NCT00379340|P4|Participant Flow|Stage IV With Non-lung Disease Treated With Regimen M|Stage IV with non-lung disease treated with Regimen M.
1173153|NCT00379340|P3|Participant Flow|Stage III/IV With LOH 1p and 16q Treated With Regimen M|Stage III/IV with LOH 1p and 16q treated with Regimen M.
1173154|NCT00379340|P2|Participant Flow|Stage IV and Slow Incomplete Response (SIR) of Lung Metastases|Stage IV and slow incomplete response (SIR) of lung metastases treated with Regimen M after 6 weeks of DD4A.
1173155|NCT00379340|P1|Participant Flow|Stage IV and Rapid Complete Response (RCR) of Lung Metastases|Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A.
1173156|NCT00379340|O2|Outcome|Lung Mets > 1cm|Lung mets > 1cm
1173157|NCT00379340|O1|Outcome|Lung Mets <= 1cm|Lung mets <= 1cm
1173194|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173158|NCT00379340|O2|Outcome|Stage IV With Non-lung Disease Treated With Regimen M|"Stage IV with non-lung disease treated with Regimen M~doxorubicin hydrochloride: Given IV~liposomal vincristine sulfate: Given IV~conventional surgery~dactinomycin: Given IV~cyclophosphamide: Given IV~etoposide: Given IV"
1173159|NCT00379340|O1|Outcome|Stage III/IV With LOH 1p and 16q Treated With Regimen M|"Stage III/IV with LOH 1p and 16q treated with Regimen M~doxorubicin hydrochloride: Given IV~liposomal vincristine sulfate: Given IV~conventional surgery~3-dimensional conformal radiation therapy~dactinomycin: Given IV~cyclophosphamide: Given IV~etoposide: Given IV"
1173160|NCT00379340|O1|Outcome|Stage IV and Slow Incomplete Response (SIR) of Lung Metastases|"Stage IV and slow incomplete response (SIR) of lung metastases treated with Regimen M after 6 weeks of DD4A~doxorubicin hydrochloride: Given IV~liposomal vincristine sulfate: Given IV~conventional surgery~3-dimensional conformal radiation therapy~dactinomycin: Given IV~cyclophosphamide: Given IV~etoposide: Given IV"
1173161|NCT00379340|O1|Outcome|Stage IV and Rapid Complete Response (RCR) of Lung Metastases|Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A.
1173162|NCT00379340|E5|Reported Event|Stage IV With Lung Metastases|Stage IV with lung metastases treated with DD4A for less than 6 weeks and/or response inevaluable at week 6.
1173163|NCT00379340|E4|Reported Event|Stage IV With Non-lung Disease Treated With Regimen M|Stage IV with non-lung disease treated with Regimen M.
1173164|NCT00379340|E3|Reported Event|Stage III/IV With LOH 1p and 16q Treated With Regimen M|Stage III/IV with LOH 1p and 16q treated with Regimen M.
1173165|NCT00379340|E2|Reported Event|Stage IV and Slow Incomplete Response (SIR) of Lung Metastases|Stage IV and slow incomplete response (SIR) of lung metastases treated with Regimen M after 6 weeks of DD4A.
1173166|NCT00379340|E1|Reported Event|Stage IV and Rapid Complete Response (RCR) of Lung Metastases|Stage IV and rapid complete response (RCR) of lung metastases continuously treated with DD4A after 6 weeks of DD4A.
1173167|NCT00379288|B5|Baseline|Total|Total of all reporting groups
1173168|NCT00379288|B4|Baseline|F/SC 500/50 mcg BID|F/SC 500/50 twice daily for 1 year
1173169|NCT00379288|B3|Baseline|F/SC 250/50 mcg BID|F/SC 250/50 twice daily for 1 year
1173170|NCT00379288|B2|Baseline|MF/F 400/10 mcg BID|MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
1173171|NCT00379288|B1|Baseline|MF/F 200/10 mcg BID|MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
1173172|NCT00379288|P4|Participant Flow|F/SC 500/50 mcg BID|F/SC 500/50 twice daily for 1 year
1173173|NCT00379288|P3|Participant Flow|F/SC 250/50 mcg BID|fluticasone/salmeterol combination (F/SC) 250/50 twice daily for 1 year
1173174|NCT00379288|P2|Participant Flow|MF/F 400/10 mcg BID|MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
1173175|NCT00379288|P1|Participant Flow|MF/F 200/10 mcg BID|mometasone furoate/formoterol (MF/F) 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
1173176|NCT00379288|O4|Outcome|F/SC 500/50 mcg BID|F/SC 500/50 twice daily for 1 year
1173177|NCT00379288|O3|Outcome|F/SC 250/50 mcg BID|F/SC 250/50 twice daily for 1 year
1173178|NCT00379288|O2|Outcome|MF/F 400/10 mcg BID|MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
1173179|NCT00379288|O1|Outcome|MF/F 200/10 mcg BID|MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
1173180|NCT00379288|E4|Reported Event|F/SC MDI 500/50 mcg BID|F/SC 500/50 twice daily for 1 year
1173181|NCT00379288|E3|Reported Event|F/SC MDI 250/50 mcg BID|F/SC 250/50 twice daily for 1 year
1173182|NCT00379288|E2|Reported Event|MF/F MDI 400/10 mcg BID|MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
1173183|NCT00379288|E1|Reported Event|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
1173184|NCT00379236|B3|Baseline|Total|Total of all reporting groups
1173185|NCT00379236|B2|Baseline|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173186|NCT00379236|B1|Baseline|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173187|NCT00379236|P3|Participant Flow|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
1173188|NCT00379236|P2|Participant Flow|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173189|NCT00379236|P1|Participant Flow|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173190|NCT00379236|O1|Outcome|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
1173191|NCT00379236|O1|Outcome|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
1173192|NCT00379236|O1|Outcome|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
1173193|NCT00379236|O1|Outcome|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
1173586|NCT00377832|O1|Outcome|In Labor With a Fever Will Give no Medication|
1173195|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173196|NCT00379236|O2|Outcome|Placebo Double-Blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173197|NCT00379236|O1|Outcome|EUFLEXXA™ Double-Blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173198|NCT00379236|O2|Outcome|Placebo Double-Blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173199|NCT00379236|O1|Outcome|EUFLEXXA™ Double-Blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173200|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173201|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173202|NCT00379236|O2|Outcome|Placebo Double-Blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173203|NCT00379236|O1|Outcome|EUFLEXXA™ Double Blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173204|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173205|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173206|NCT00379236|O2|Outcome|Placebo Double-Blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173207|NCT00379236|O1|Outcome|EUFLEXXA™ Double-Blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173208|NCT00379236|O1|Outcome|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
1173209|NCT00379236|O1|Outcome|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
1173545|NCT00377858|B1|Baseline|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
1173210|NCT00379236|O1|Outcome|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
1173211|NCT00379236|O1|Outcome|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
1173212|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173213|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173214|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173215|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173216|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173217|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173218|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173219|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173587|NCT00377832|O2|Outcome|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
1173220|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173221|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173222|NCT00379236|O2|Outcome|Placebo Double-Blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173223|NCT00379236|O1|Outcome|EUFLEXXA™ Double-Blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173224|NCT00379236|O2|Outcome|Placebo Double-Blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173225|NCT00379236|O1|Outcome|EUFLEXXA™ Double-Blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173226|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173227|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173228|NCT00379236|E3|Reported Event|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
1173229|NCT00379236|E2|Reported Event|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173230|NCT00379236|E1|Reported Event|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
1173231|NCT00379210|B3|Baseline|Total|Total of all reporting groups
1173232|NCT00379210|B2|Baseline|Nutrition Education Group|Nutrition education group - received information about nutrition
1173233|NCT00379210|B1|Baseline|Mindfulness Training Group|Meditation training group-- received Mindfulness Based Stress Management from the Penn Program for Stress Management
1173234|NCT00379210|P2|Participant Flow|Nutrition Education Group|Nutrition education group - received information about nutrition
1173235|NCT00379210|P1|Participant Flow|Mindfulness Training Group|Meditation training group-- received Mindfulness Based Stress Management from the Penn Program for Stress Management
1173236|NCT00379210|O2|Outcome|Nutrition Education Group|Nutrition education group - received information about nutrition
1173237|NCT00379210|O1|Outcome|Mindfulness Training Group|Meditation training group-- received Mindfulness Based Stress Management from the Penn Program for Stress Management
1173238|NCT00379210|E2|Reported Event|Nutrition Education Group|Nutrition education group - received information about nutrition
1173239|NCT00379210|E1|Reported Event|Mindfulness Training Group|Meditation training group-- received Mindfulness Based Stress Management from the Penn Program for Stress Management
1173240|NCT00379197|B1|Baseline|Naltrexone|"Naltrexone hydrochloride 50 mg will be taken once a day every day of a 28 day treatment course. Positron-emission tomography (PET) / computed tomography (CT) given with injection of 2-Deoxy-2-[18F]fluoro-D-Glucose (FDG).~naltrexone hydrochloride: Naltrexone should be taken with water or food, and it can be taken at any time day. Naltrexone 50 mg will be taken once a day every day of a 28 day treatment course.~Positron-emission tomography (PET) / computed tomography (CT): Given with injection of 2-Deoxy-2-[18F]fluoro-D-Glucose (FDG). Follow-up scans will be performed after the completion of cycle 1 and cycle 2 and during the 1 year follow-up."
1173241|NCT00379197|P1|Participant Flow|Naltrexone|Naltrexone 50 mg taken orally once daily for 2 28-day cycles with an option to continue on Naltrexone at the discretion of the treating physician.
1173242|NCT00379197|O1|Outcome|Naltrexone|"Naltrexone 50 mg will be taken orally once a day every day of a 28 day treatment course (cycle 1) and continue for another identical 28 day treatment (cycle 2) . PET scan will be performed after cycle 1 and cycle 2 complete.~naltrexone: Naltrexone 50 mg will be orally taken once daily for 28 day (cycle 1), and continues once daily for another 28 days (cycle 2) without interval.~PET scan: Patients will receive PET scan approximately one hour after being injected with 2-Deoxy-2-[18F]fluoro-D-Glucose (FDG). PET scans will be performed after the completion of cycle 1 and cycle 2 and during the 1 year follow-up."
1173243|NCT00379197|O1|Outcome|Naltrexone Treatment|Naltrexone 50 mg will be orally taken once daily for 28 day (cycle 1), and continues once daily for another 28 days (cycle 2) without interval. PET scan will be performed as baseline level at the beginning of study and after the completion of cycle 1 and cycle 2.
1173244|NCT00379197|E1|Reported Event|Naltrexone Treatment|Naltrexone 50 mg will be orally taken once daily for 28 day (cycle 1), and continues once daily for another 28 days (cycle 2) without interval. PET scan will be performed after the completion of cycle 1 and cycle 2 and during the 1 year follow-up compared to the baseline level of FDG uptake.
1173245|NCT00379080|B4|Baseline|Total|Total of all reporting groups
1173246|NCT00379080|B3|Baseline|Arm 3 - Phase 2|"Patients receive tandutinib as in phase I at the MTD determined in phase I.~600mg was the determined MTD in Dose Escalation~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
1173247|NCT00379080|B2|Baseline|Arm 2 - Phase 1|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~tandutinib: Given orally~pharmacological study: Correlative studies"
1173248|NCT00379080|B1|Baseline|Arm 1 - Phase 0|"Patients receive oral tandutinib twice daily for 7 days. Patients then undergo biopsy or surgery to remove the tumor. Within 2 weeks after biopsy or surgery, patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~conventional surgery~oral tandutinib~Pharmacological study~Tissue samples"
1173249|NCT00379080|P3|Participant Flow|Arm 3 - Phase 2|"Patients receive tandutinib as in phase I at the MTD determined in phase I.~600mg was the determined MTD in Dose Escalation~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
1173250|NCT00379080|P2|Participant Flow|Arm 2 - Phase 1|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~tandutinib: Given orally~pharmacological study: Correlative studies"
1173251|NCT00379080|P1|Participant Flow|Arm 1- Phase 0|"Patients receive oral tandutinib twice daily for 7 days. Patients then undergo biopsy or surgery to remove the tumor. Within 2 weeks after biopsy or surgery, patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~conventional surgery~oral tandutinib~Pharmacological study~Tissue samples"
1173252|NCT00379080|O10|Outcome|Association Between PFS Biomarker Day 28 / BL|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation~oral tandutinib~tandutinib: Given orally~pharmacological study: Correlative studies~Peripheral blood"
1173253|NCT00379080|O9|Outcome|Association Between OS and Biomarker Day 28 / BL|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation~oral tandutinib~tandutinib: Given orally~pharmacological study: Correlative studies~Peripheral blood"
1173254|NCT00379080|O8|Outcome|Association Between PFS Biomarker Day 10 / BL|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation~oral tandutinib~tandutinib: Given orally~pharmacological study: Correlative studies~Peripheral blood"
1173255|NCT00379080|O7|Outcome|Association Between OS and Biomarker Day 10 /BL|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation~oral tandutinib~tandutinib: Given orally~pharmacological study: Correlative studies~Peripheral blood"
1173256|NCT00379080|O6|Outcome|Association Between PFS Biomarker Day 8 / BL|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation~oral tandutinib~tandutinib: Given orally~pharmacological study: Correlative studies~Peripheral blood"
1173257|NCT00379080|O5|Outcome|Association Between OS and Biomarker Day 8 / BL|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation~oral tandutinib~tandutinib: Given orally~pharmacological study: Correlative studies~Peripheral blood"
1173258|NCT00379080|O4|Outcome|Association Between PFS Biomarker Day 2 / BL|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation~oral tandutinib~tandutinib: Given orally~pharmacological study: Correlative studies~Peripheral blood"
1173259|NCT00379080|O3|Outcome|Association Between OS and Biomarker Day 2 / BL|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation~oral tandutinib~tandutinib: Given orally~pharmacological study: Correlative studies~Peripheral blood"
1173260|NCT00379080|O2|Outcome|Baseline (BL) - Progression Free Survival (PFS)|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation~oral tandutinib~tandutinib: Given orally~pharmacological study: Correlative studies~Peripheral blood"
1173261|NCT00379080|O1|Outcome|Baseline (BL) - Overall Survival (OS)|"Patients receive tandutinib at 600mg as was the determined MTD in Dose Escalation~oral tandutinib~tandutinib: Given orally~pharmacological study: Correlative studies~Peripheral blood"
1173370|NCT00378508|O1|Outcome|Teplizumab Infusions (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
1173262|NCT00379080|O1|Outcome|Arm 3 - Phase 2|"Patients receive tandutinib as in phase I at the MTD determined in phase I.~600mg was the determined MTD in Dose Escalation~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
1173263|NCT00379080|O1|Outcome|Arm 3 - Phase 2|"Patients receive tandutinib as in phase I at the MTD determined in phase I.~600mg was the determined MTD in Dose Escalation~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
1173264|NCT00379080|O1|Outcome|Arm 3 - Phase 2|"Patients receive tandutinib as in phase I at the MTD determined in phase I.~600mg was the determined MTD in Dose Escalation~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
1173265|NCT00379080|O1|Outcome|Arm 3 - Phase 2|"Patients receive tandutinib as in phase I at the MTD determined in phase I.~600mg was the determined MTD in Dose Escalation~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
1173266|NCT00379080|O3|Outcome|Level 3 - 700mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~dose for tandtinib is 700mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
1173267|NCT00379080|O2|Outcome|Level 2 - 600mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~Phase 2: MTD dose Patients receive tandutinib as in phase I at the MTD (600mg BID) determined in phase I.~600mg was the determined MTD in Dose Escalation~dose for tandtinib is 600mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
1173290|NCT00379080|E3|Reported Event|Arm 3 - Phase 2|"Patients receive tandutinib as in phase I at the MTD determined in phase I.~600mg was the determined MTD in Dose Escalation~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
1173394|NCT00378378|O2|Outcome|MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years|Subject 12 to less than 18 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) once per day (QD)
1173268|NCT00379080|O1|Outcome|Level 1 - 500mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~dose for tandtinib is 500mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
1173269|NCT00379080|O3|Outcome|Level 3 - 700mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~dose for tandtinib is 700mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
1173270|NCT00379080|O2|Outcome|Level 2 - 600mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~Phase 2: MTD dose Patients receive tandutinib as in phase I at the MTD (600mg BID) determined in phase I.~600mg was the determined MTD in Dose Escalation~dose for tandtinib is 600mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
1173271|NCT00379080|O1|Outcome|Level 1 - 500mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~dose for tandtinib is 500mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
1173272|NCT00379080|O3|Outcome|Level 3 - 700mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~dose for tandtinib is 700mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
1173273|NCT00379080|O2|Outcome|Level 2 - 600mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~Phase 2: MTD dose Patients receive tandutinib as in phase I at the MTD (600mg BID) determined in phase I.~600mg was the determined MTD in Dose Escalation~dose for tandtinib is 600mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
1173274|NCT00379080|O1|Outcome|Level 1 - 500mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~dose for tandtinib is 500mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
1173275|NCT00379080|O3|Outcome|Level 3 - 700mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~dose for tandtinib is 700mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
1173276|NCT00379080|O2|Outcome|Level 2 - 600mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~Phase 2: MTD dose Patients receive tandutinib as in phase I at the MTD (600mg BID) determined in phase I.~600mg was the determined MTD in Dose Escalation~dose for tandtinib is 600mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
1173277|NCT00379080|O1|Outcome|Level 1 - 500mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~dose for tandtinib is 500mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
1173278|NCT00379080|O3|Outcome|Level 3 - 700mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~dose for tandtinib is 700mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
1173279|NCT00379080|O2|Outcome|Level 2 - 600mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~Phase 2: MTD dose Patients receive tandutinib as in phase I at the MTD (600mg BID) determined in phase I.~600mg was the determined MTD in Dose Escalation~dose for tandtinib is 600mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
1173280|NCT00379080|O1|Outcome|Level 1 - 500mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~dose for tandtinib is 500mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
1173281|NCT00379080|O3|Outcome|Level 3 - 700mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~dose for tandtinib is 700mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
1173282|NCT00379080|O2|Outcome|Level 2 - 600mg BID (Phase 1 & Phase 2)|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~Phase 2: MTD dose Patients receive tandutinib as in phase I at the MTD (600mg BID) determined in phase I.~600mg was the determined MTD in Dose Escalation~dose for tandtinib is 600mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
1173283|NCT00379080|O1|Outcome|Level 1 - 500mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~dose for tandtinib is 500mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
1173284|NCT00379080|O1|Outcome|Arm 3 - Phase 2|"Patients receive tandutinib as in phase I at the MTD determined in phase I.~600mg was the determined MTD in Dose Escalation~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
1173425|NCT00378352|O1|Outcome|Epoetin Alfa|Highest dose cohort (60,000 U of epoetin alfa)
1173426|NCT00378352|E2|Reported Event|Placebo|Patients who received placebo
1173285|NCT00379080|O3|Outcome|Level 3 - 700mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~dose for tandtinib is 700mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
1173286|NCT00379080|O2|Outcome|Level 2 - 600mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~dose for tandtinib is 600mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
1173287|NCT00379080|O1|Outcome|Level 1 - 500mg BID|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~dose for tandtinib is 500mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
1173288|NCT00379080|O1|Outcome|Arm I - Feasibility|"Participants receive oral tandutinib 500 mg twice daily for 7 days prior to surgery. Patients then undergo biopsy or surgery to remove the tumor. Tissue collected for tumor/plasma ratio.~Post surgery, within 2 weeks after biopsy or surgery, patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. (not necessary for feasibility)~conventional surgery~oral tandutinib~Pharmacological study~Tissue samples~conventional surgery: Undergo surgery~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
1173289|NCT00379080|O1|Outcome|Reporting Group - Phase 1|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. All dose Levels~tandutinib: Given orally~pharmacological study: Correlative studies"
1173291|NCT00379080|E2|Reported Event|Arm 2 - Dose Escalation (Phase 1)|"Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of tandutinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.~the starting dose for tandtinib is 500mg BID~oral tandutinib~Pharmacological study~Tissue samples~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
1173292|NCT00379080|E1|Reported Event|Arm I - Feasibility|"Patients receive oral tandutinib twice daily for 7 days. Patients then undergo biopsy or surgery to remove the tumor. Within 2 weeks after biopsy or surgery, patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~conventional surgery~oral tandutinib~Pharmacological study~Tissue samples~conventional surgery: Undergo surgery~tandutinib: Given orally~pharmacological study: Correlative studies~Tissue samples: Correlative studies"
1173293|NCT00378898|B3|Baseline|Total|Total of all reporting groups
1173294|NCT00378898|B2|Baseline|EGD With Sham BRAVO Capsule Placement|Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed.
1173295|NCT00378898|B1|Baseline|EGD With BRAVO Capsule|"Bravo PH capsule: egd with bravo placement~Fluoroscopy: one time xray to determine evacuation of bravo"
1173296|NCT00378898|P2|Participant Flow|EGD With Sham BRAVO Capsule Placement|Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed.
1173297|NCT00378898|P1|Participant Flow|EGD With BRAVO Capsule|"Bravo PH capsule:egd with bravo placement~Fluoroscopy: one time xray to determine evacuation of bravo"
1173298|NCT00378898|O2|Outcome|EGD With Sham BRAVO Capsule Placement|"Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed.~sham BRAVO capsule placement"
1173299|NCT00378898|O1|Outcome|EGD With Proximal BRAVO Capsule|"Subjects have a second BRAVO capsule placed 10cm proximal to prior BRAVO capsule placement. Fluoroscopy is used to confirm detachment of the monitor 7 days after investigational deployment.~BRAVO capsule~Fluoroscopy: one time xray to determine evacuation of bravo"
1173300|NCT00378898|O2|Outcome|Sham Comparator: EGD With Sham BRAVO Capsule Placement|Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed.
1173301|NCT00378898|O1|Outcome|EGD With BRAVO Capsule|"Bravo PH capsule: egd with bravo placement~Fluoroscopy: one time xray to determine evacuation of bravo"
1173302|NCT00378898|E2|Reported Event|EGS With Sham BRAVO Capsule Placement|Subjects have a EGD with BRAVO delivery introducer positioned 10cm proximal to prior BRAVO capsule placement with no BRAVO placed. Analysis is for participants who completed the study.
1173303|NCT00378898|E1|Reported Event|EGD With BRAVO Capsule|"Bravo PH capsule: egd with bravo placement. Analysis is for participants who completed the study.~Fluoroscopy: one time xray to determine evacuation of bravo"
1173393|NCT00378378|O3|Outcome|Pooled Placebo|All placebo groups were combined
1173588|NCT00377832|O1|Outcome|In Labor With a Fever Will Give no Medication|
1173333|NCT00378599|B1|Baseline|PEG-Intron Plus Ribavirin|PEG-Intron plus ribavirin treatment for up to 48 weeks with 24-week follow up
1173334|NCT00378599|P1|Participant Flow|PEG-Intron Plus Ribavirin|PEG-Intron plus ribavirin treatment for up to 48 weeks with 24-week follow up
1173335|NCT00378599|O1|Outcome|PEG-Intron Plus Ribavirin|PEG-Intron plus ribavirin treatment for up to 48 weeks with 24-week follow up
1173336|NCT00378599|E1|Reported Event|Pegylated Interferon Alfa-2b and Ribavirin|
1173427|NCT00378352|E1|Reported Event|Epoetin Alfa|Patients who received active study medication
1178720|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
1173337|NCT00378573|B1|Baseline|Docetaxel, Gemcitabine and Bevacizumab|Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
1173338|NCT00378573|P1|Participant Flow|Docetaxel, Gemcitabine and Bevacizumab|Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
1173339|NCT00378573|O1|Outcome|Docetaxel, Gemcitabine and Bevacizumab|Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
1173340|NCT00378573|O1|Outcome|Docetaxel, Gemcitabine and Bevacizumab|Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
1173341|NCT00378573|O1|Outcome|Docetaxel, Gemcitabine and Bevacizumab|Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
1173342|NCT00378573|E1|Reported Event|Docetaxel, Gemcitabine and Bevacizumab|Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
1173343|NCT00378560|B3|Baseline|Total|Total of all reporting groups
1173344|NCT00378560|B2|Baseline|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
1173345|NCT00378560|B1|Baseline|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
1173346|NCT00378560|P2|Participant Flow|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
1173347|NCT00378560|P1|Participant Flow|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
1173348|NCT00378560|O2|Outcome|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
1173349|NCT00378560|O1|Outcome|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
1173350|NCT00378560|O2|Outcome|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
1173351|NCT00378560|O1|Outcome|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
1173352|NCT00378560|O2|Outcome|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
1173353|NCT00378560|O1|Outcome|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
1173354|NCT00378560|O2|Outcome|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
1173355|NCT00378560|O1|Outcome|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
1173356|NCT00378560|O2|Outcome|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
1173357|NCT00378560|O1|Outcome|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
1173358|NCT00378560|E2|Reported Event|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
1173359|NCT00378560|E1|Reported Event|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
1173589|NCT00377832|O2|Outcome|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
1173360|NCT00378534|B1|Baseline|Hematologic Survival Using Miltenyi Reagent System|Subjects with hematological malignancies receiving a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation followed by an infusion of stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a delayed T cell depletion add back as donor lymphocyte infucion at day 90. The subjects receiveing allogeneic stem cell transplantation will have stem cell product prepared using Miltenyi CliniMacs system to determine the overall survival and non-relapse at day +200.
1173361|NCT00378534|P1|Participant Flow|CD34 Selection|"T cell depletion~Miltenyi Clinimax CD34 Reagent System: T cell depletion"
1173362|NCT00378534|O1|Outcome|Hematologic Survival Using Miltenyi Reagent System|Subjects with hematological malignancies receiving a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation followed by an infusion of stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a delayed T cell depletion add back as donor lymphocyte infucion at day 90. The subjects receiveing allogeneic stem cell transplantation will have stem cell product prepared using Miltenyi CliniMacs system to determine the overall survival and non-relapse at day +200.
1173363|NCT00378534|E1|Reported Event|Transplant Recipients|"T cell depletion~Miltenyi Clinimax CD34 Reagent System: T cell depletion"
1173364|NCT00378508|B3|Baseline|Total|Total of all reporting groups
1173365|NCT00378508|B2|Baseline|Teplizumab Infusions (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
1173366|NCT00378508|B1|Baseline|Saline Infusions (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
1173367|NCT00378508|P2|Participant Flow|Teplizumab Infusion (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
1173368|NCT00378508|P1|Participant Flow|Saline Infusions (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
1173369|NCT00378508|O2|Outcome|Saline Infusions (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
1173371|NCT00378508|O2|Outcome|Saline Infusion (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
1173372|NCT00378508|O1|Outcome|Teplizumab Infusions (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
1173373|NCT00378508|O2|Outcome|Saline Infusions (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
1173374|NCT00378508|O1|Outcome|Teplizumab Infusions (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
1173375|NCT00378508|O2|Outcome|Saline Infusion (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
1173376|NCT00378508|O1|Outcome|Teplizumab Infusions (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
1173377|NCT00378508|O2|Outcome|Saline Infusions (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
1173378|NCT00378508|O1|Outcome|Teplizumab Infusions (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
1173379|NCT00378508|O2|Outcome|Saline Infusions (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
1173380|NCT00378508|O1|Outcome|Teplizumab Infusions (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
1173381|NCT00378508|E2|Reported Event|Teplizumab Infusion (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
1173382|NCT00378508|E1|Reported Event|Saline Infusions (Placebo)|The course of a saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
1173383|NCT00378378|B4|Baseline|Total|Total of all reporting groups
1173384|NCT00378378|B3|Baseline|Pooled Placebo|All placebo groups were combined
1173385|NCT00378378|B2|Baseline|MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years|Subject 12 to less than 18 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) once per day (QD)
1173386|NCT00378378|B1|Baseline|MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years|Subjects 6 to less than 12 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) twice per day (BID)
1173387|NCT00378378|P3|Participant Flow|Pooled Placebo|All placebo groups were combined
1173388|NCT00378378|P2|Participant Flow|MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years|Subject 12 to less than 18 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) once per day (QD)
1173389|NCT00378378|P1|Participant Flow|MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years|Subjects 6 to less than 12 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) twice per day (BID)
1173390|NCT00378378|O3|Outcome|Pooled Placebo|All placebo groups were combined
1173391|NCT00378378|O2|Outcome|MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years|Subject 12 to less than 18 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) once per day (QD)
1173392|NCT00378378|O1|Outcome|MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years|Subjects 6 to less than 12 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) twice per day (BID)
1173395|NCT00378378|O1|Outcome|MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years|Subjects 6 to less than 12 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) twice per day (BID)
1173396|NCT00378378|E3|Reported Event|Placebo|
1173397|NCT00378378|E2|Reported Event|MFNS 100 or 200 mcg BID|
1173398|NCT00378378|E1|Reported Event|MFNS 100 or 200 mcg QD|
1173399|NCT00378352|B3|Baseline|Total|Total of all reporting groups
1173400|NCT00378352|B2|Baseline|Placebo|Dose escalation and efficacy phases
1173401|NCT00378352|B1|Baseline|Epoetin Alfa|Dose escalation and efficacy phases
1173402|NCT00378352|P6|Participant Flow|Efficacy Phase Placebo|Single dose placebo
1173403|NCT00378352|P5|Participant Flow|Efficacy Phase 60,000 Units Epoetin Alfa|Prospective, randomized, double-blind, placebo-controlled trial Single dose 60000 U of epoetin alfa
1173404|NCT00378352|P4|Participant Flow|Dose Escalation Placebo|
1173405|NCT00378352|P3|Participant Flow|Dose Escalation 60,000 Units Epoetin Alfa|
1173406|NCT00378352|P2|Participant Flow|Dose Escalation 30,000 Units Epoetin Alfa|
1173407|NCT00378352|P1|Participant Flow|Dose Escalation 15,000 Units Epoetin Alfa|
1173408|NCT00378352|O2|Outcome|Placebo|Dose escalation and efficacy phases
1173409|NCT00378352|O1|Outcome|Epoetin Alfa|Dose escalation and efficacy phases
1173410|NCT00378352|O2|Outcome|Placebo|Dose escalation and efficacy phases
1173411|NCT00378352|O1|Outcome|Epoetin Alfa|Dose escalation and efficacy phases
1173412|NCT00378352|O2|Outcome|Placebo|Dose escalation and efficacy phases
1173413|NCT00378352|O1|Outcome|Epoetin Alfa|Dose escalation and efficacy phases
1173414|NCT00378352|O2|Outcome|Placebo|Dose escalation and efficacy phases
1173415|NCT00378352|O1|Outcome|Epoetin Alfa|Dose escalation and efficacy phases
1173416|NCT00378352|O2|Outcome|Placebo|Placebo for the highest dose
1173417|NCT00378352|O1|Outcome|Epoetin Alfa|Highest dose cohort (60,000 U of epoetin alfa)
1173418|NCT00378352|O2|Outcome|Placebo|Placebo for the highest dose
1173419|NCT00378352|O1|Outcome|Epoetin Alfa|Highest dose cohort (60,000 U of epoetin alfa)
1173420|NCT00378352|O2|Outcome|Placebo|Placebo for the highest dose
1173421|NCT00378352|O1|Outcome|Epoetin Alfa|Highest dose cohort (60,000 U of epoetin alfa)
1173422|NCT00378352|O2|Outcome|Placebo|Placebo for the highest dose
1173423|NCT00378352|O1|Outcome|Epoetin Alfa|Highest dose cohort (60,000 U of epoetin alfa)
1173424|NCT00378352|O2|Outcome|Placebo|Placebo for the highest dose
1173428|NCT00378326|B1|Baseline|Tacrolimus|Tacrolimus at doses of 0.15- 0.3mg/kg/day in two divided oral doses, in conjunction with, initially, up to 60mg/day of oral prednisone
1173429|NCT00378326|P1|Participant Flow|Tacrolimus|Tacrolimus at doses of 0.15- 0.3mg/kg/day in two divided oral doses, in conjunction with, initially, up to 60mg/day of oral prednisone
1173430|NCT00378326|O1|Outcome|Tacrolimus|Tacrolimus at doses of 0.15-0.3mg/kg/day in two divided oral doses, in conjunction with, initially, up to 60mg/day of oral prednisone
1173431|NCT00378326|O2|Outcome|Post-treatment|White blood cell (WBC) count in CSF post-treatment
1173432|NCT00378326|O1|Outcome|Pre-treatment|White blood cell (WBC) count in CSF pre-treatment
1173433|NCT00378326|E1|Reported Event|All Patients|All patients enrolled
1173434|NCT00378209|B1|Baseline|Lenalidomide, Dexamethasone, Bortezomib Combination|"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.~Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9."
1173435|NCT00378209|P1|Participant Flow|Lenalidomide, Dexamethasone, Bortezomib Combination|"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.~Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9."
1173436|NCT00378209|O1|Outcome|Lenalidomide, Dexamethasone, Bortezomib Combination|
1173437|NCT00378209|O1|Outcome|Lenalidomide, Dexamethasone, Bortezomib Combination|"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.~Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9."
1173462|NCT00378079|O2|Outcome|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
1173463|NCT00378079|O1|Outcome|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
1173438|NCT00378209|O1|Outcome|Lenalidomide, Dexamethasone, Bortezomib Combination|"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.~Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9."
1173439|NCT00378209|O1|Outcome|Lenalidomide, Dexamethasone, Bortezomib Combination|"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.~Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9."
1173440|NCT00378209|O1|Outcome|Lenalidomide, Dexamethasone, Bortezomib Combination|"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.~Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9."
1173477|NCT00378079|E2|Reported Event|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
1173478|NCT00378079|E1|Reported Event|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
1173479|NCT00378014|B3|Baseline|Total|Total of all reporting groups
1178721|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
1173441|NCT00378209|E1|Reported Event|Lenalidomide, Dexamethasone, Bortezomib Combination|"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.~Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9."
1173442|NCT00378105|B3|Baseline|Total|Total of all reporting groups
1173443|NCT00378105|B2|Baseline|Phase 2 Population|
1173444|NCT00378105|B1|Baseline|Phase 1 Population|
1173445|NCT00378105|P2|Participant Flow|Phase 2 Pupulation|Each subject received the maximum planned dose of 1.3 mg/m2/IV bortezomib daily Days 1, 4, 8 and 11 followed by a 10-day rest period, 20 mg PO dexamethasone single daily oral dose Days 1, 2, 4, 5, 8, 9, 11, 12 and25 mg/PO/QD (every day)lenalidomide daily Days 1-14 followed by 7-day rest every 21 days x 4 cycles and then at 10 mg/day on the same schedule for cycles 5 – 8. Each cycle of treatment consisted of 21 days.
1173446|NCT00378105|P1|Participant Flow|Phase 1 Population|"Four levels of dose were evaluated and a standard 3+3 dose escalation schema was used to determine the MTD and additional patients were evaluated on the MTD level.~Level 1 1 mg/m2/IV bortezomib daily Days 1,4, 8 and 11 40 mg PO dexamethasone daily Days 1, 2, 4, 5, 8, 9, 11, 12 and 15 mg/PO/day lenalidomide daily Days 1-14 followed by 7-day rest every 21 days~Level 2 1.3 mg/m2/IV bortezomib daily Days 1,4, 8 and 11 40 mg PO dexamethasone daily Days 1, 2, 4, 5, 8, 9, 11, 12 and 15 mg/PO/day lenalidomide daily Days 1-14 followed by 7-day rest every 21 days~Level 3 1.3 mg/m2/IV bortezomib daily Days 1,4, 8 and 11 40 mg PO dexamethasone daily Days 1, 2, 4, 5, 8, 9, 11, 12 and 20 mg/PO/day lenalidomide daily Days 1-14 followed by 7-day rest every 21 days~Level 4 1.3 mg/m2/IV bortezomib daily Days 1,4, 8 and 11 40 mg PO dexamethasone daily Days 1, 2, 4, 5, 8, 9, 11, 12 and 25 mg/PO/day lenalidomide daily Days 1-14 followed by 7-day rest every 21 days"
1173447|NCT00378105|O1|Outcome|All Patients|
1173448|NCT00378105|O1|Outcome|All Patients|
1173449|NCT00378105|O1|Outcome|All Patients|
1173450|NCT00378105|O3|Outcome|Total|
1173451|NCT00378105|O2|Outcome|Phase II Population|
1173452|NCT00378105|O1|Outcome|Phase 1 Population|
1173453|NCT00378105|E1|Reported Event|All Patients|
1173454|NCT00378079|B4|Baseline|Total|Total of all reporting groups
1173455|NCT00378079|B3|Baseline|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
1173456|NCT00378079|B2|Baseline|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
1173457|NCT00378079|B1|Baseline|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
1173458|NCT00378079|P3|Participant Flow|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
1173459|NCT00378079|P2|Participant Flow|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
1173460|NCT00378079|P1|Participant Flow|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
1173461|NCT00378079|O3|Outcome|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
1173464|NCT00378079|O3|Outcome|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
1173465|NCT00378079|O2|Outcome|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
1173466|NCT00378079|O1|Outcome|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
1173467|NCT00378079|O3|Outcome|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
1173468|NCT00378079|O2|Outcome|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
1173469|NCT00378079|O1|Outcome|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
1173470|NCT00378079|O3|Outcome|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
1173471|NCT00378079|O2|Outcome|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
1173472|NCT00378079|O1|Outcome|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
1173473|NCT00378079|O3|Outcome|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
1173474|NCT00378079|O2|Outcome|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
1173475|NCT00378079|O1|Outcome|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
1173476|NCT00378079|E3|Reported Event|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
1173480|NCT00378014|B2|Baseline|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
1173481|NCT00378014|B1|Baseline|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
1173482|NCT00378014|P2|Participant Flow|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
1173483|NCT00378014|P1|Participant Flow|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
1173484|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
1173485|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
1173486|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
1173487|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
1173488|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
1173489|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
1173490|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
1173491|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
1173492|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
1173493|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
1173494|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
1173495|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
1173496|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
1173497|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
1173575|NCT00377832|B2|Baseline|Acetaminophen 975 mg Once|
1173576|NCT00377832|B1|Baseline|No Medication|
1173498|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
1173499|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
1173500|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
1173501|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
1173502|NCT00378014|E4|Reported Event|Extension Period - CNI|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
1173503|NCT00378014|E3|Reported Event|Extension Period - Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
1173504|NCT00378014|E2|Reported Event|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
1173505|NCT00378014|E1|Reported Event|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
1173506|NCT00377962|B3|Baseline|Total|Total of all reporting groups
1173507|NCT00377962|B2|Baseline|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
1173508|NCT00377962|B1|Baseline|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
1173509|NCT00377962|P2|Participant Flow|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
1173527|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
1173510|NCT00377962|P1|Participant Flow|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
1173511|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
1173512|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
1173513|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
1173514|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
1173515|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
1173516|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
1173517|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
1173518|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
1173519|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
1173577|NCT00377832|P2|Participant Flow|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
1173578|NCT00377832|P1|Participant Flow|In Labor With a Fever Will Give no Medication|
1173579|NCT00377832|O2|Outcome|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
1173580|NCT00377832|O1|Outcome|In Labor With a Fever Will Give no Medication|
1173520|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
1173521|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
1173522|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
1173523|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
1173524|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
1173525|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
1173526|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
1173528|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
1173529|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
1173530|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
1173531|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
1173532|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
1173533|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
1173534|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
1173535|NCT00377962|E8|Reported Event|Everolimus + CNI Reduction: 24 Month Lung|"Subgroup of everolimus + CNI reduction group with lung patients at 24 months. Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%, upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice."
1173536|NCT00377962|E7|Reported Event|Control: 24 Month Lung|"Subgroup of Control group with lung patients at 24 months. CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice."
1173581|NCT00377832|O2|Outcome|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
1173582|NCT00377832|O1|Outcome|In Labor With a Fever Will Get no Medication|
1173583|NCT00377832|O2|Outcome|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
1173537|NCT00377962|E6|Reported Event|Everolimus + CNI Reduction: 24 Month Heart|"Subgroup of everolimus + CNI reduction group with heart patients at 24 months. Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%, upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice."
1173538|NCT00377962|E5|Reported Event|Control: 24 Month Heart|"Subgroup of Control group with heart patients at 24 months. CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice."
1173539|NCT00377962|E4|Reported Event|Everolimus+CNI Reduction: 12 Month Lung|"Subgroup of everolimus + CNI reduction group with lung patients at 12 months. Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%, upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice."
1173540|NCT00377962|E3|Reported Event|Control: 12 Month Lung|"Subgroup of control group with lung patients at 12 months. CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice."
1173541|NCT00377962|E2|Reported Event|Everolimus + CNI Reduction: 12 Month Heart|"Subgroup of everolimus + CNI reduction group with heart patients at 12 months. Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%, upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice."
1173542|NCT00377962|E1|Reported Event|Control: 12 Month Heart|"Subgroup of Control group with heart patients at 12 months. CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice."
1173543|NCT00377858|B3|Baseline|Total|Total of all reporting groups
1173544|NCT00377858|B2|Baseline|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
1173546|NCT00377858|P2|Participant Flow|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
1173547|NCT00377858|P1|Participant Flow|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
1173548|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
1173549|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
1173550|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
1173551|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
1173552|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
1173553|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
1173554|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
1173555|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
1173556|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
1173557|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
1173558|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
1173559|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
1173560|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
1173561|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
1173562|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
1173563|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
1173564|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
1173565|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
1173566|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
1173567|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
1173568|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
1173569|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
1173570|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
1173571|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
1173572|NCT00377858|E2|Reported Event|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
1173573|NCT00377858|E1|Reported Event|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
1173574|NCT00377832|B3|Baseline|Total|Total of all reporting groups
1173590|NCT00377832|O1|Outcome|In Labor With a Fever Will Give no Medication|
1173591|NCT00377832|O2|Outcome|Acetaminophen 975 mg Once|
1173592|NCT00377832|O1|Outcome|No Medication|
1173593|NCT00377832|O2|Outcome|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
1173594|NCT00377832|O1|Outcome|In Labor With a Fever Will Give no Medication|
1173595|NCT00377832|E2|Reported Event|Acetaminophen 975 mg Once|In labor, fever is identified, consent and randomization occurs, then acetaminophen is given.
1173596|NCT00377832|E1|Reported Event|No Medication|In labor, fever is identified, consent and randomization occurs, then no medication is given.
1173597|NCT00377819|B3|Baseline|Total|Total of all reporting groups
1173598|NCT00377819|B2|Baseline|Denosumab 60 mg Q6M|60 mg denosumab administered subcutaneously once every 6 months (Q6M) plus placebo for alendronate once weekly (QW) orally
1173599|NCT00377819|B1|Baseline|Alendronate 70 mg QW|70 mg alendronate once weekly (QW) orally plus placebo for denosumab subcutaneously once every 6 months (Q6M)
1173600|NCT00377819|P2|Participant Flow|Denosumab 60 mg Q6M|60 mg denosumab administered subcutaneously once every 6 months (Q6M) plus placebo for alendronate once weekly (QW) orally
1173601|NCT00377819|P1|Participant Flow|Alendronate 70 mg QW|70 mg alendronate once weekly (QW) orally plus placebo for denosumab subcutaneously once every 6 months (Q6M)
1173602|NCT00377819|O2|Outcome|Denosumab 60 mg Q6M|60 mg denosumab administered subcutaneously once every 6 months (Q6M) plus placebo for alendronate once weekly (QW) orally
1173603|NCT00377819|O1|Outcome|Alendronate 70 mg QW|70 mg alendronate once weekly (QW) orally plus placebo for denosumab subcutaneously once every 6 months (Q6M)
1173604|NCT00377819|O2|Outcome|Denosumab 60 mg Q6M|60 mg denosumab administered subcutaneously once every 6 months (Q6M) plus placebo for alendronate once weekly (QW) orally
1173605|NCT00377819|O1|Outcome|Alendronate 70 mg QW|70 mg alendronate once weekly (QW) orally plus placebo for denosumab subcutaneously once every 6 months (Q6M)
1173606|NCT00377819|O2|Outcome|Denosumab 60 mg Q6M|60 mg denosumab administered subcutaneously once every 6 months (Q6M) plus placebo for alendronate once weekly (QW) orally
1173607|NCT00377819|O1|Outcome|Alendronate 70 mg QW|70 mg alendronate once weekly (QW) orally plus placebo for denosumab subcutaneously once every 6 months (Q6M)
1173608|NCT00377819|E2|Reported Event|Denosumab 60 mg Q6M|
1173609|NCT00377819|E1|Reported Event|Alendronate 70 mg QW|
1173610|NCT00377741|B3|Baseline|Total|Total of all reporting groups
1173611|NCT00377741|B2|Baseline|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
1173612|NCT00377741|B1|Baseline|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
1178722|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
1173613|NCT00377741|P2|Participant Flow|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
1173614|NCT00377741|P1|Participant Flow|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
1173615|NCT00377741|O2|Outcome|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
1173616|NCT00377741|O1|Outcome|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
1173617|NCT00377741|O2|Outcome|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
1173618|NCT00377741|O1|Outcome|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
1173619|NCT00377741|O2|Outcome|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
1173620|NCT00377741|O1|Outcome|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
1173621|NCT00377741|O2|Outcome|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
1173622|NCT00377741|O1|Outcome|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
1173623|NCT00377741|O2|Outcome|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
1173624|NCT00377741|O1|Outcome|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
1173625|NCT00377741|E2|Reported Event|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
1173626|NCT00377741|E1|Reported Event|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
1173627|NCT00377676|B3|Baseline|Total|Total of all reporting groups
1173628|NCT00377676|B2|Baseline|Placebo|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
1173629|NCT00377676|B1|Baseline|Cycloset|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
1173630|NCT00377676|P2|Participant Flow|Placebo|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
1173631|NCT00377676|P1|Participant Flow|Cycloset|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
1180117|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1173632|NCT00377676|O2|Outcome|Placebo|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
1173633|NCT00377676|O1|Outcome|Cycloset|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
1173634|NCT00377676|O2|Outcome|Placebo|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
1173635|NCT00377676|O1|Outcome|Cycloset|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
1173636|NCT00377676|O2|Outcome|Placebo|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
1173637|NCT00377676|O1|Outcome|Cycloset|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
1173638|NCT00377676|O2|Outcome|Placebo|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
1173666|NCT00377637|O1|Outcome|Intravenous Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
1173639|NCT00377676|O1|Outcome|Cycloset|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
1173640|NCT00377676|E2|Reported Event|Placebo|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
1173641|NCT00377676|E1|Reported Event|Cycloset|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
1173642|NCT00377637|B5|Baseline|Total|Total of all reporting groups
1173643|NCT00377637|B4|Baseline|Maintenance Phase: Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
1173644|NCT00377637|B3|Baseline|Maintenance Phase: Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
1173645|NCT00377637|B2|Baseline|Induction Phase: Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
1173646|NCT00377637|B1|Baseline|Induction Phase: Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
1173647|NCT00377637|P4|Participant Flow|Maintenance Phase: Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
1173648|NCT00377637|P3|Participant Flow|Maintenance Phase: Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
1173649|NCT00377637|P2|Participant Flow|Induction Phase: Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
1173650|NCT00377637|P1|Participant Flow|Induction Phase: Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
1173651|NCT00377637|O2|Outcome|Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
1173652|NCT00377637|O1|Outcome|Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
1173653|NCT00377637|O2|Outcome|Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
1173781|NCT00377312|P2|Participant Flow|Group 2|PTH (1-34) 4 picomoles (pmols)/kg/hr
1173654|NCT00377637|O1|Outcome|Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
1173655|NCT00377637|O2|Outcome|Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
1173656|NCT00377637|O1|Outcome|Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
1173657|NCT00377637|O2|Outcome|Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
1173658|NCT00377637|O1|Outcome|Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
1173659|NCT00377637|O2|Outcome|Azathioprine (AZA)|Azathioprine (AZA) 2.0 mg/kg/day along with placebo matching MMF (1.0 g BID), plus corticosteroid for 36 months of therapy
1173660|NCT00377637|O1|Outcome|Mycophenolate Mofetil (MMF)|Mycophenolate mofetil (MMF) 1.0 g twice daily (BID) along with placebo matching AZA (2.0 mg/kg/day), plus corticosteroid, until 36 months of therapy.
1173661|NCT00377637|O2|Outcome|Azathioprine (AZA)|Azathioprine (AZA) 2 mg/kg/day orally once a day + Placebo to MMF orally twice a day + Corticosteroid for 36 months.
1173662|NCT00377637|O1|Outcome|Mycophenolate Mofetil (MMF)|Mycophenolate mofetil (MMF) 1.0 g orally twice a day + Placebo to Azathioprine orally once a day + Corticosteroid for 36 months
1173663|NCT00377637|O2|Outcome|Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
1173664|NCT00377637|O1|Outcome|Intravenous Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
1173665|NCT00377637|O2|Outcome|Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
1178723|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
1173667|NCT00377637|O2|Outcome|Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
1173668|NCT00377637|O1|Outcome|Intravenous Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
1173669|NCT00377637|O2|Outcome|Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
1173670|NCT00377637|O1|Outcome|Intravenous Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
1173671|NCT00377637|O2|Outcome|Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
1173672|NCT00377637|O1|Outcome|Intravenous Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
1173673|NCT00377637|O2|Outcome|Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
1173674|NCT00377637|O1|Outcome|Intravenous Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
1173675|NCT00377637|O2|Outcome|Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
1173676|NCT00377637|O1|Outcome|Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
1173677|NCT00377637|O2|Outcome|Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
1173678|NCT00377637|O1|Outcome|Intravenous Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
1173679|NCT00377637|E4|Reported Event|Maintenance Phase: Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
1173680|NCT00377637|E3|Reported Event|Maintenance Phase: Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
1173681|NCT00377637|E2|Reported Event|Induction Phase: Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
1173682|NCT00377637|E1|Reported Event|Induction Phase: Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
1173683|NCT00377572|B3|Baseline|Total|Total of all reporting groups
1173782|NCT00377312|P1|Participant Flow|Group 1|PTH (1-34) 2 picomoles (pmols)/kg/hr
1173684|NCT00377572|B2|Baseline|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173685|NCT00377572|B1|Baseline|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173686|NCT00377572|P2|Participant Flow|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total immunoglobulin E (IgE) level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173687|NCT00377572|P1|Participant Flow|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total immunoglobulin E (IgE) level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173688|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173741|NCT00377429|E1|Reported Event|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
1173742|NCT00377403|B3|Baseline|Total|Total of all reporting groups
1173743|NCT00377403|B2|Baseline|Symptomatic Treatments Only|Placebo for 10 days in addition to symptomatic treatments
1173744|NCT00377403|B1|Baseline|Intervention Arm|Amoxicillin 500mg tid for 10 days in addition to symptomatic treatments
1173689|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173690|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173691|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173692|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173693|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173694|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173695|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173696|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173783|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
1173784|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
1173785|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
1173786|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
1173787|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
1173697|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173698|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173699|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173700|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173701|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173702|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173703|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173704|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173705|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173706|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173707|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173708|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173709|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173788|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
1173789|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
1173790|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
1173791|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
1173792|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
1173710|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173711|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173712|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173713|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173714|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173715|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173716|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173717|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173718|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173719|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173720|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173721|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173722|NCT00377572|E2|Reported Event|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173793|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
1173794|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
1173795|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
1173796|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
1173797|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
1173723|NCT00377572|E1|Reported Event|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
1173724|NCT00377520|B1|Baseline|Pemetrexed|900 mg/m2, intravenous (IV), every 21 days, until disease progression
1173725|NCT00377520|P1|Participant Flow|Pemetrexed|900 mg/m2, intravenous (IV), every 21 days, until disease progression
1173726|NCT00377520|O1|Outcome|Pemetrexed|900 mg/m2, intravenous (IV), every 21 days, until disease progression
1173727|NCT00377520|O1|Outcome|Pemetrexed|900 mg/m2, intravenous (IV), every 21 days, until disease progression
1173728|NCT00377520|E1|Reported Event|Pemetrexed|900 mg/m2, intravenous (IV), every 21 days, until disease progression
1173729|NCT00377455|B1|Baseline|Bosentan and Placebo Arms|This group consists of subjects on both arms of the study - bosentan and placebo
1173730|NCT00377455|P1|Participant Flow|Bosentan and Placebo Arms|This group consists of subjects on both arms of the study - bosentan and placebo
1173731|NCT00377455|O1|Outcome|Bosentan/Placebo|Outcomes not available, due to early termination of study
1173732|NCT00377455|E1|Reported Event|Bosentan and Placebo Arms|This group consists of subjects on both arms of the study - bosentan and placebo
1173733|NCT00377429|B1|Baseline|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
1173734|NCT00377429|P1|Participant Flow|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
1173735|NCT00377429|O1|Outcome|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
1173736|NCT00377429|O1|Outcome|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
1173737|NCT00377429|O1|Outcome|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
1173738|NCT00377429|O1|Outcome|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
1173739|NCT00377429|O1|Outcome|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
1173740|NCT00377429|O1|Outcome|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
1173745|NCT00377403|P2|Participant Flow|Symptomatic Treatments Only|Placebo for 10 days in addition to symptomatic treatments
1173746|NCT00377403|P1|Participant Flow|Intervention Arm|Amoxicillin 500mg tid for 10 days in addition to symptomatic treatments
1173747|NCT00377403|O2|Outcome|Symptomatic Treatments Only|Placebo for 10 days in addition to symptomatic treatments
1173748|NCT00377403|O1|Outcome|Intervention Arm|Amoxicillin 500mg tid for 10 days in addition to symptomatic treatments
1173749|NCT00377403|E2|Reported Event|Symptomatic Treatments Only|Placebo for 10 days in addition to symptomatic treatments
1173750|NCT00377403|E1|Reported Event|Intervention Arm|Amoxicillin 500mg tid for 10 days in addition to symptomatic treatments
1173751|NCT00377364|B3|Baseline|Total|Total of all reporting groups
1173752|NCT00377364|B2|Baseline|Placebo|Matching Placebo.
1173753|NCT00377364|B1|Baseline|Acetaminophen|OTC pain reliever.fever reducer that may have neuroprotective effects.
1173754|NCT00377364|P2|Participant Flow|Placebo|Matching Placebo.
1173755|NCT00377364|P1|Participant Flow|Acetaminophen|OTC pain reliever.fever reducer that may have neuroprotective effects.
1173756|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
1173757|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever and fever reducer that may have neuroprotective effects.
1173758|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
1173759|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever and fever reducer that may have neuroprotective effects.
1173760|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
1173761|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever.fever reducer that may have neuroprotective effects.
1173762|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
1173763|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever and fever reducer that may have neuroprotective effects.
1173764|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
1173765|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever.fever reducer that may have neuroprotective effects.
1173766|NCT00377364|O2|Outcome|Placebo|Matching placebo.
1173767|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever and fever reducer that may have neuroprotective effects.
1173768|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
1173769|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever and fever reducer that may have neuroprotective effects.
1173770|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
1173771|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever and fever reducer that may have neuroprotective effects.
1173772|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
1173773|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever and fever reducer that may have neuroprotective effects.
1173774|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
1173775|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever and fever reducer that may have neuroprotective effects.
1173776|NCT00377364|E2|Reported Event|Placebo|Matching Placebo.
1173777|NCT00377364|E1|Reported Event|Acetaminophen|OTC pain reliever.fever reducer that may have neuroprotective effects.
1173778|NCT00377312|B3|Baseline|Total|Total of all reporting groups
1173779|NCT00377312|B2|Baseline|Parathyroid Hormone(1-34) - 4 Picomoles/kg/hr|Subjects received Parathyroid Hormone (1-34)intravenously at 4 picomoles/kg/hr.
1173780|NCT00377312|B1|Baseline|Parathyroid Hormone - 2 Picomoles/kg/hr.|Subjects initially entering the study receive study drug Parathyroid Hormone (1-34) in intravenous doses beginning at 2 picomoles/kg/hr. Doses will be slowly and safely escalated in groups of 3 subjects.
1173799|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
1173800|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
1173801|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
1173802|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
1173803|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
1173804|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
1173805|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
1173806|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
1173807|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
1173808|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
1173809|NCT00377312|E2|Reported Event|Group 2|PTH (1-34) 4 picomoles (pmols)/kg/hr
1173810|NCT00377312|E1|Reported Event|Group 1|PTH (1-34) 2 picomoles (pmols)/kg/hr
1173811|NCT00377299|B3|Baseline|Total|Total of all reporting groups
1173812|NCT00377299|B2|Baseline|Placebo|
1173813|NCT00377299|B1|Baseline|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
1173814|NCT00377299|P2|Participant Flow|Placebo|Placebo identical in appearance to the medication was given beginning at one tablet with an increase to two tablets at week 2, three tablets at week 4 and four tablets at week 6. Patients remained on four tables throughout the remaining weeks of the study (week 12). Doses were decreased, if needed, due to side effects.
1173815|NCT00377299|P1|Participant Flow|Citicoline|Citicoline add-on therapy was given beginning at one tablet(500mg/day) with an increase to two tablets(1000mg/day) at week 2, three tablets(1500mg/day)at week 4 and four tablets (2000mg/day) at week 6. Patients remained on 2000mg/day throughout the remaining weeks of the study (week 12). Doses were decreased, if needed, due to side effects.
1173816|NCT00377299|O2|Outcome|Placebo|Placebo.
1173817|NCT00377299|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
1173818|NCT00377299|O2|Outcome|Placebo|Placebo matching Citicoline.
1173819|NCT00377299|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
1173820|NCT00377299|O2|Outcome|Placebo|Placebo matching Citicoline.
1173821|NCT00377299|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
1173822|NCT00377299|O2|Outcome|Placebo|Placebo.
1173984|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
1173823|NCT00377299|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
1173824|NCT00377299|O2|Outcome|Placebo|Placebo.
1173825|NCT00377299|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
1173826|NCT00377299|E2|Reported Event|Placebo|
1173827|NCT00377299|E1|Reported Event|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
1173828|NCT00377260|B3|Baseline|Total|Total of all reporting groups
1173829|NCT00377260|B2|Baseline|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
1173830|NCT00377260|B1|Baseline|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
1173831|NCT00377260|P2|Participant Flow|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
1173832|NCT00377260|P1|Participant Flow|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
1173833|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
1173834|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
1173835|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
1173836|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
1173837|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
1173838|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
1173839|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
1173840|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
1173841|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
1173842|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
1173843|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
1173844|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
1173845|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
1173846|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
1173847|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
1173848|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
1173849|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
1173850|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
1173851|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
1173852|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
1173853|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
1173854|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
1183686|NCT00349908|O2|Outcome|Group 2|Aneurysm Arm
1173855|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
1173856|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
1173857|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
1173858|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
1173859|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
1173860|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
1173861|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
1173862|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
1173863|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
1173864|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
1173865|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
1173866|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
1173867|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
1173868|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
1173869|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
1173870|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
1173871|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
1173872|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
1173873|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
1173874|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
1173875|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
1173876|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
1173877|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
1173878|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
1173879|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
1173880|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
1173881|NCT00377260|E2|Reported Event|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
1173882|NCT00377260|E1|Reported Event|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
1173883|NCT00377234|B3|Baseline|Total|Total of all reporting groups
1173884|NCT00377234|B2|Baseline|Sequence B|Risedronate followed by ibandronate
1173885|NCT00377234|B1|Baseline|Sequence A|Ibandronate followed by risedronate
1173886|NCT00377234|P2|Participant Flow|Sequence B|Risedronate followed by ibandronate
1173887|NCT00377234|P1|Participant Flow|Sequence A|Ibandronate followed by risedronate
1173888|NCT00377234|O2|Outcome|Sequence B|risedronate followed by ibandronate
1173889|NCT00377234|O1|Outcome|Sequence A|ibandronate followed by risedronate
1173890|NCT00377234|O2|Outcome|Sequence B|risedronate followed by ibandronate
1173891|NCT00377234|O1|Outcome|Sequence A|ibandronate followed by risedronate
1173892|NCT00377234|O2|Outcome|Risedronate|While being treated with risendronate
1173893|NCT00377234|O1|Outcome|Ibandronate|While being treated with ibandronate
1173894|NCT00377234|O3|Outcome|Total|During period 1 + during period 2
1173895|NCT00377234|O2|Outcome|During Sequence B|Risedronate followed by ibandronate
1173896|NCT00377234|O1|Outcome|During Sequence A|Ibandronate followed by risedronate
1173897|NCT00377234|O3|Outcome|Total|During period 1 + during period 2
1173898|NCT00377234|O2|Outcome|During Sequence B|Risendronate followed by ibandronate
1173899|NCT00377234|O1|Outcome|During Sequence A|Ibandronate followed by risedronate
1173900|NCT00377234|E2|Reported Event|Risedronate|Risendronate adverse events
1173901|NCT00377234|E1|Reported Event|Ibandronate|Ibandronate adverse events
1173902|NCT00376961|B1|Baseline|Rituximab-CHOP-Bortezomib (R-CHOP-V)|R-CHOP-V will be administered for 6 cycles (one cycle is defined as a single 21-day course of treatment).
1173903|NCT00376961|P2|Participant Flow|Bortezomib Maintenance (VM)|Bortezomib maintenance (VM) therapy is given 3 months after the completion of R-CHOP-V induction therapy. Treatment with VM is administered once every 3 month for 8 cycles, Cycle 7-14 ( 1 cycle = 3 months)
1173904|NCT00376961|P1|Participant Flow|Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction|Rituximab-CHOP-Bortezomib (R-CHOP-V) induction is administered every 21 days for 6 cycles (1 cycle = 21 days)
1173905|NCT00376961|O2|Outcome|Bortezomib Maintenance (VM)|Bortezomib maintenance (VM) therapy is given 3 months after the completion of R-CHOP-V induction therapy. Treatment with VM is administered once every 3 month for 8 cycles, Cycle 7-14 ( 1 cycle = 3 months)
1173906|NCT00376961|O1|Outcome|Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction|Rituximab-CHOP-Bortezomib (R-CHOP-V) induction is administered every 21 days for 6 cycles (1 cycle = 21 days)
1173907|NCT00376961|O1|Outcome|R-CHOP-V Followed by VM|Rituximab-CHOP-bortezomib induction therapy (RCHOP-V) followed by Bortezomib maintenance therapy (VM). R-CHOP-V is administered for 6 cycles (1 cycle = 21 dyas). Bortezomib maintenance (VM) therapy is given 3 months after the completion of R-CHOP-V induction therapy. Treatment with VM is administered once every 3 month for 8 cycles, Cycle 7-14 ( 1 cycle = 3 months)
1174107|NCT00375973|B1|Baseline|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
1173908|NCT00376961|O1|Outcome|R-CHOP-V Followed by VM|Rituximab-CHOP-bortezomib induction therapy (RCHOP-V) followed by Bortezomib maintenance therapy (VM). R-CHOP-V is administered for 6 cycles (1 cycle = 21 days). Bortezomib maintenance (VM) therapy is given 3 months after the completion of R-CHOP-V induction therapy. Treatment with VM is administered once every 3 month for 8 cycles, Cycle 7-14 ( 1 cycle = 3 months)
1173909|NCT00376961|O1|Outcome|R-CHOP-V Followed by VM|Rituximab-CHOP-bortezomib induction therapy (RCHOP-V) followed by Bortezomib maintenance therapy (VM). R-CHOP-V is administered for 6 cycles (1 cycle = 21 days). Bortezomib maintenance (VM) therapy is given 3 months after the completion of R-CHOP-V induction therapy. Treatment with VM is administered once every 3 month for 8 cycles, Cycle 7-14 ( 1 cycle = 3 months)
1173910|NCT00376961|E2|Reported Event|Bortezomib Maintenance (VM)|Bortezomib maintenance (VM) therapy is given 3 months after the completion of R-CHOP-V induction therapy. Treatment with VM is administered once every 3 month for 8 cycles, Cycle 7-14 ( 1 cycle = 3 months)
1173911|NCT00376961|E1|Reported Event|Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction|Rituximab-CHOP-Bortezomib (R-CHOP-V) induction is administered every 21 days for 6 cycles (1 cycle= 21 days)
1173912|NCT00376948|B1|Baseline|Novasoy®, Gemcitabine & Erlotinib|"Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, & 15; Erlotinib 150 mg day 1 until day 28~genistein~erlotinib hydrochloride~gemcitabine hydrochloride"
1173913|NCT00376948|P1|Participant Flow|Novasoy®, Gemcitabine & Erlotinib|"Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, & 15; Erlotinib 150 mg day 1 until day 28~genistein~erlotinib hydrochloride~gemcitabine hydrochloride"
1173914|NCT00376948|O1|Outcome|Novasoy®, Gemcitabine & Erlotinib|"Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, & 15; Erlotinib 150 mg day 1 until day 28~genistein~erlotinib hydrochloride~gemcitabine hydrochloride"
1173915|NCT00376948|O1|Outcome|Novasoy®, Gemcitabine & Erlotinib|"Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, & 15; Erlotinib 150 mg day 1 until day 28~genistein~erlotinib hydrochloride~gemcitabine hydrochloride"
1173916|NCT00376948|E1|Reported Event|Novasoy®, Gemcitabine & Erlotinib|"Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, & 15; Erlotinib 150 mg day 1 until day 28~genistein~erlotinib hydrochloride~gemcitabine hydrochloride"
1173917|NCT00376935|B5|Baseline|Total|Total of all reporting groups
1173918|NCT00376935|B4|Baseline|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173919|NCT00376935|B3|Baseline|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173920|NCT00376935|B2|Baseline|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173921|NCT00376935|B1|Baseline|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173922|NCT00376935|P4|Participant Flow|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173923|NCT00376935|P3|Participant Flow|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173924|NCT00376935|P2|Participant Flow|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173925|NCT00376935|P1|Participant Flow|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173926|NCT00376935|O4|Outcome|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173927|NCT00376935|O3|Outcome|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173928|NCT00376935|O2|Outcome|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173929|NCT00376935|O1|Outcome|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173930|NCT00376935|O4|Outcome|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173931|NCT00376935|O3|Outcome|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173932|NCT00376935|O2|Outcome|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173933|NCT00376935|O1|Outcome|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173934|NCT00376935|O4|Outcome|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173935|NCT00376935|O3|Outcome|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1174108|NCT00375973|P2|Participant Flow|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
1183687|NCT00349908|O1|Outcome|Group 1|Atherosclerosis
1173936|NCT00376935|O2|Outcome|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173937|NCT00376935|O1|Outcome|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173938|NCT00376935|O4|Outcome|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173939|NCT00376935|O3|Outcome|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173940|NCT00376935|O2|Outcome|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173941|NCT00376935|O1|Outcome|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173942|NCT00376935|O4|Outcome|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173943|NCT00376935|O3|Outcome|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173944|NCT00376935|O2|Outcome|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173945|NCT00376935|O1|Outcome|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173946|NCT00376935|O4|Outcome|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173947|NCT00376935|O3|Outcome|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173948|NCT00376935|O2|Outcome|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173949|NCT00376935|O1|Outcome|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173950|NCT00376935|O4|Outcome|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173951|NCT00376935|O3|Outcome|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173952|NCT00376935|O2|Outcome|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173953|NCT00376935|O1|Outcome|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173954|NCT00376935|O4|Outcome|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173955|NCT00376935|O3|Outcome|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173956|NCT00376935|O2|Outcome|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173957|NCT00376935|O1|Outcome|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173958|NCT00376935|E4|Reported Event|Palifermin (60 Mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173959|NCT00376935|E3|Reported Event|Palifermin (40 Mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173960|NCT00376935|E2|Reported Event|Palifermin (20 Mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173961|NCT00376935|E1|Reported Event|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
1173962|NCT00376805|B1|Baseline|NK Cells With or Without Total Body Irradiation|Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
1173963|NCT00376805|P1|Participant Flow|NK Cells With or Without Total Body Irradiation|Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
1173964|NCT00376805|O1|Outcome|NK Cells With or Without Total Body Irradiation|Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
1173965|NCT00376805|O1|Outcome|NK Cells With or Without Total Body Irradiation|Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
1176856|NCT00368069|O1|Outcome|Keppra®|Keppra® extended release formulation (XR)
1173966|NCT00376805|O1|Outcome|NK Cells With or Without Total Body Irradiation|Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
1173967|NCT00376805|O1|Outcome|NK Cells With or Without Total Body Irradiation|Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
1173968|NCT00376805|E1|Reported Event|NK Cells With or Without Total Body Irradiation|Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
1173969|NCT00376688|B1|Baseline|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Temsirolimus: Given IV"
1173970|NCT00376688|P1|Participant Flow|Temsirolimus|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Temsirolimus: Given IV"
1173971|NCT00376688|O1|Outcome|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Temsirolimus: Given IV"
1173972|NCT00376688|E1|Reported Event|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Temsirolimus: Given IV"
1173973|NCT00376675|B3|Baseline|Total|Total of all reporting groups
1173974|NCT00376675|B2|Baseline|Placebo|Patients receive oral placebo daily on days 1-28.
1173975|NCT00376675|B1|Baseline|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
1173976|NCT00376675|P2|Participant Flow|Placebo|Patients receive oral placebo daily on days 1-28.
1173977|NCT00376675|P1|Participant Flow|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
1173978|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
1173979|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
1173980|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
1173981|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
1173982|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
1173983|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
1173985|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
1173986|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
1173987|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
1173988|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
1173989|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
1173990|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
1173991|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
1173992|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
1173993|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
1173994|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
1173995|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
1173996|NCT00376675|E2|Reported Event|Placebo|Patients receive oral placebo daily on days 1-28.
1173997|NCT00376675|E1|Reported Event|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
1173998|NCT00375518|B3|Baseline|Total|Total of all reporting groups
1173999|NCT00375518|B2|Baseline|Placebo|Placebo: Placebo given beginning 7 days before the operation. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
1174000|NCT00375518|B1|Baseline|Atorvastatin|Atorvastatin: Atorvastatin 40 mg once a day beginning 7 days before the operation. Surgical procedures will be as planned and unaffected by this study. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
1174001|NCT00375518|P2|Participant Flow|Placebo|Placebo: Placebo given beginning 7 days before the operation. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
1174002|NCT00375518|P1|Participant Flow|Atorvastatin|Atorvastatin: Atorvastatin 40 mg once a day beginning 7 days before the operation. Surgical procedures will be as planned and unaffected by this study. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
1174003|NCT00375518|O2|Outcome|Placebo|Placebo: Placebo given beginning 7 days before the operation. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
1174004|NCT00375518|O1|Outcome|Atorvastatin|Atorvastatin: Atorvastatin 40 mg once a day beginning 7 days before the operation. Surgical procedures will be as planned and unaffected by this study. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
1174005|NCT00375518|E2|Reported Event|Placebo|Placebo: Placebo given beginning 7 days before the operation. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
1174006|NCT00375518|E1|Reported Event|Atorvastatin|Atorvastatin: Atorvastatin 40 mg once a day beginning 7 days before the operation. Surgical procedures will be as planned and unaffected by this study. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
1174007|NCT00376558|B3|Baseline|Total|Total of all reporting groups
1174008|NCT00376558|B2|Baseline|Control Subjects|Healthy controls who undergo scans
1174009|NCT00376558|B1|Baseline|Cocaine Users|Cocaine users receiving CRA
1174010|NCT00376558|P2|Participant Flow|Control Subjects|Healthy controls who undergo scans
1174011|NCT00376558|P1|Participant Flow|Cocaine Users|Cocaine users receiving CRA
1176857|NCT00368069|O2|Outcome|Placebo|placebo
1174012|NCT00376558|O1|Outcome|Cocaine Abuser Undergoing CM With CRA Treatment|Participants receive voucher points for each urine sample that tested negative for benzoylecgonine. Failure to submit a scheduled sample was treated as cocaine +. Voucher points have a monetary value that can be redeemed for goods/services that are approved by the therapist. Points ($0.25) were acquired on an escalating schedule that started at 10 points for the 1st cocaine-free sample, and each subsequent cocaine-free sample increased the value by 5 points. A bonus of 40 points ($10.00) for every 3 consecutive negative sample. Abstinence was confirmed by onsite urine test (Abuscreen On-Trak system, Roche Diagnostics). Missed clinic visits and urine samples that are considered + reset the points to the initial $2.50 value and the escalation schedule resume. Submission of 5 consecutive - samples after a + urine returns the voucher points to the value prior to reset. Points earned are never lost. A maximum of $997.50 is earned for submitting negative samples at all treatment visits.
1174013|NCT00376558|O2|Outcome|Control Subjects|Healthy controls who undergo scans
1174014|NCT00376558|O1|Outcome|Cocaine Users|Cocaine users receiving CRA
1174015|NCT00376558|E2|Reported Event|Control Subjects|Healthy controls who undergo scans
1174016|NCT00376558|E1|Reported Event|Cocaine Users|Cocaine users receiving CRA
1174017|NCT00376532|B3|Baseline|Total|Total of all reporting groups
1174018|NCT00376532|B2|Baseline|No ICD Pacing or Shock Event|Subjects who did not experience a treatment defined as a pacing event or a shock event
1174019|NCT00376532|B1|Baseline|ICD Pacing or Shock Event|Subjects who experienced a device treatment, defined as a pacing event or a shock event
1174020|NCT00376532|P2|Participant Flow|No ICD Event|Subjects who did not experience a treatment defined as a pacing event or a shock event
1174021|NCT00376532|P1|Participant Flow|ICD Event|Subjects who experienced a device treatment, defined as a pacing event or a shock event
1174022|NCT00376532|O2|Outcome|No ICD Pacing or Shock Event|Subjects who did not experience a treatment defined as a pacing event or a shock event
1174023|NCT00376532|O1|Outcome|ICD Pacing or Shock Event|Subjects who experienced a device treatment, defined as a pacing event or a shock event
1174024|NCT00376532|O2|Outcome|No ICD Pacing or Shock Event|Subjects who did not experience a treatment defined as a pacing event or a shock event
1174025|NCT00376532|O1|Outcome|ICD Pacing or Shock Event|Subjects who experienced a device treatment, defined as a pacing event or a shock event
1174026|NCT00376532|E2|Reported Event|No ICD Pacing or Shock Event|Subjects who did not experience a treatment defined as a pacing event or a shock event
1174027|NCT00376532|E1|Reported Event|ICD Pacing or Shock Event|Subjects who experienced a device treatment, defined as a pacing event or a shock event
1174028|NCT00376506|B3|Baseline|Total|Total of all reporting groups
1174029|NCT00376506|B2|Baseline|Intramuscular|An implanted neurostimulator device used for swallowing retraining
1174030|NCT00376506|B1|Baseline|Vibrotactile|An external vibrotactile device used for swallowing retraining
1174031|NCT00376506|P2|Participant Flow|Intramuscular|An implanted neurostimulator device used for swallowing retraining
1174032|NCT00376506|P1|Participant Flow|Vibrotactile|An external vibrotactile device used for swallowing retraining
1174033|NCT00376506|O2|Outcome|Intramuscular|Patients utilized an implanted neurostimulator device for swallowing retraining. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
1174034|NCT00376506|O1|Outcome|Vibrotactile|Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
1174035|NCT00376506|O2|Outcome|Intramuscular|Patients used a surgically implanted intramuscular stimulation device. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
1174036|NCT00376506|O1|Outcome|Vibrotactile|Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
1174037|NCT00376506|O2|Outcome|Intramuscular|Patients used a surgically implanted intramuscular stimulation device. Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
1174038|NCT00376506|O1|Outcome|Vibrotactile|Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
1174039|NCT00376506|O2|Outcome|Intramuscular|Patients utilized an implanted neurostimulator device for swallowing retraining. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
1174040|NCT00376506|O1|Outcome|Vibrotactile|Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
1174041|NCT00376506|O2|Outcome|Intramuscular|Patients utilized an implanted neurostimulator device for swallowing. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.retraining
1174042|NCT00376506|O1|Outcome|Vibrotactile|Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
1174043|NCT00376506|O2|Outcome|Intramuscular|Patients used a surgically implanted intramuscular stimulation device. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
1174111|NCT00375973|O1|Outcome|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
1174044|NCT00376506|O1|Outcome|Vibrotactile|Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
1174045|NCT00376506|E2|Reported Event|Intramuscular|An implanted neurostimulator device used for swallowing retraining
1174046|NCT00376506|E1|Reported Event|Vibrotactile|An external vibrotactile device used for swallowing retraining
1174047|NCT00376363|B3|Baseline|Total|Total of all reporting groups
1174048|NCT00376363|B2|Baseline|Baerveldt Implant|"Baerveldt glaucoma drainage implant for intraocular pressure control~Baerveldt implant: placement of glaucoma drainage device to control intraocular press"
1174049|NCT00376363|B1|Baseline|Ahmed Implant,1|"Ahmed glaucoma drainage implant for intraocular pressure control~Ahmed implant: placement of glaucoma drainage device to control intraocular pressure"
1174050|NCT00376363|P2|Participant Flow|Baerveldt Implant|"Baerveldt glaucoma drainage implant for intraocular pressure control~Baerveldt implant: placement of glaucoma drainage device to control intraocular press"
1174051|NCT00376363|P1|Participant Flow|Ahmed Implant,1|"Ahmed glaucoma drainage implant for intraocular pressure control~Ahmed implant: placement of glaucoma drainage device to control intraocular pressure"
1174052|NCT00376363|O2|Outcome|Baerveldt Implant|"Baerveldt glaucoma drainage implant for intraocular pressure control~Baerveldt implant: placement of glaucoma drainage device to control intraocular press"
1174053|NCT00376363|O1|Outcome|Ahmed Implant,1|"Ahmed glaucoma drainage implant for intraocular pressure control~Ahmed implant: placement of glaucoma drainage device to control intraocular pressure"
1174054|NCT00376363|O2|Outcome|Baerveldt Implant|"Baerveldt glaucoma drainage implant for intraocular pressure control~Baerveldt implant: placement of glaucoma drainage device to control intraocular press"
1174055|NCT00376363|O1|Outcome|Ahmed Implant,1|"Ahmed glaucoma drainage implant for intraocular pressure control~Ahmed implant: placement of glaucoma drainage device to control intraocular pressure"
1174056|NCT00376363|O2|Outcome|Baerveldt Implant|"Baerveldt glaucoma drainage implant for intraocular pressure control~Baerveldt implant: placement of glaucoma drainage device to control intraocular press"
1174057|NCT00376363|O1|Outcome|Ahmed Implant,1|"Ahmed glaucoma drainage implant for intraocular pressure control~Ahmed implant: placement of glaucoma drainage device to control intraocular pressure"
1174058|NCT00376363|E2|Reported Event|Baerveldt Implant|"Baerveldt glaucoma drainage implant for intraocular pressure control~Baerveldt implant: placement of glaucoma drainage device to control intraocular press"
1174495|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
1174059|NCT00376363|E1|Reported Event|Ahmed Implant,1|"Ahmed glaucoma drainage implant for intraocular pressure control~Ahmed implant: placement of glaucoma drainage device to control intraocular pressure"
1174060|NCT00376259|B3|Baseline|Total|Total of all reporting groups
1174061|NCT00376259|B2|Baseline|Adefovir Monotherapy|Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
1174062|NCT00376259|B1|Baseline|Combination Therapy|Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
1174063|NCT00376259|P2|Participant Flow|Adefovir Monotherapy|Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
1174064|NCT00376259|P1|Participant Flow|Combination Therapy|Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
1174065|NCT00376259|O2|Outcome|Adefovir Monotherapy|Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
1174066|NCT00376259|O1|Outcome|Combination Therapy|Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
1174067|NCT00376259|O2|Outcome|Adefovir Monotherapy|Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
1174068|NCT00376259|O1|Outcome|Combination Therapy|Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
1174069|NCT00376259|O2|Outcome|Adefovir Monotherapy|Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
1174070|NCT00376259|O1|Outcome|Combination Therapy|Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
1174071|NCT00376259|O2|Outcome|Adefovir Monotherapy|Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
1174072|NCT00376259|O1|Outcome|Combination Therapy|Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
1174073|NCT00376259|E2|Reported Event|Adefovir Monotherapy|Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
1174074|NCT00376259|E1|Reported Event|Combination Therapy|Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
1174075|NCT00376220|B3|Baseline|Total|Total of all reporting groups
1174076|NCT00376220|B2|Baseline|Inactive/Placebo Group|Placebo: Initially dispensed 50mg capsules to take BID. At two weeks increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
1174077|NCT00376220|B1|Baseline|Active Treatment Group|Riluzole: Initially dispensed 50 mg capsules to take BID. At two weeks, increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
1174109|NCT00375973|P1|Participant Flow|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
1174110|NCT00375973|O2|Outcome|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
1174078|NCT00376220|P2|Participant Flow|Inactive/ Placebo Group|Placebo: Initially dispensed 50mg capsules to take BID. At two weeks increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
1174079|NCT00376220|P1|Participant Flow|Active Treatment Group|Riluzole: Initially dispensed 50 mg capsules to take twice daily (BID). At two weeks, increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID [two capsules in the morning (qAM), two capsules in the evening (qHS)]. If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
1174080|NCT00376220|O2|Outcome|Inactive/Placebo Group|Placebo: Initially dispensed 50mg capsules to take BID. At two weeks increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
1174081|NCT00376220|O1|Outcome|Active Treatment Group|Riluzole: Initially dispensed 50 mg capsules to take BID. At two weeks, increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
1174134|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
1174082|NCT00376220|E2|Reported Event|Inactive/Placebo Group|Placebo: Initially dispensed 50mg capsules to take BID. At two weeks increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
1174083|NCT00376220|E1|Reported Event|Active Treatment Group|Riluzole: Initially dispensed 50 mg capsules to take BID. At two weeks, increase dose to 50 mg/100 mg. At four weeks increase to 100 mg BID (two capsules qAM, two capsules qHS). If significant side effects occur (at any time), titration can be slowed and doses can be reduced to a minimum daily dose of 50 mg/day, after which titration may resume by no more than 50 mg a week. Subjects who are unable to tolerate the minimal daily dose permitted in the study will be discontinued from further participation. In addition, if clinical remission is observed at a lower dose of study medication (defined as MADRS < 12) the dose will not be increased further unless clinical symptoms recur.
1174084|NCT00376168|B3|Baseline|Total|Total of all reporting groups
1174085|NCT00376168|B2|Baseline|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
1174086|NCT00376168|B1|Baseline|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
1174087|NCT00376168|P2|Participant Flow|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
1174088|NCT00376168|P1|Participant Flow|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
1174089|NCT00376168|O2|Outcome|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
1174090|NCT00376168|O1|Outcome|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
1174091|NCT00376168|O2|Outcome|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
1174092|NCT00376168|O1|Outcome|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
1174093|NCT00376168|O2|Outcome|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
1174094|NCT00376168|O1|Outcome|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
1174095|NCT00376168|O2|Outcome|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
1174096|NCT00376168|O1|Outcome|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
1174097|NCT00376168|O2|Outcome|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
1174098|NCT00376168|O1|Outcome|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
1174099|NCT00376168|E2|Reported Event|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
1174100|NCT00376168|E1|Reported Event|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
1174101|NCT00375999|B1|Baseline|Treatment Group|Salvage Chemotherapy with Docetaxel and Epirubicin for Advanced/Metastatic Gastric Cancer
1174102|NCT00375999|P1|Participant Flow|Treatment Group|Salvage Chemotherapy with Docetaxel and Epirubicin for Advanced/Metastatic Gastric Cancer
1174103|NCT00375999|O1|Outcome|Treatment Group|Salvage Chemotherapy with Docetaxel and Epirubicin for Advanced/Metastatic Gastric Cancer
1174104|NCT00375999|E1|Reported Event|Treatment Group|Salvage Chemotherapy with Docetaxel and Epirubicin for Advanced/Metastatic Gastric Cancer
1174105|NCT00375973|B3|Baseline|Total|Total of all reporting groups
1174106|NCT00375973|B2|Baseline|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
1174112|NCT00375973|O2|Outcome|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
1174113|NCT00375973|O1|Outcome|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
1174114|NCT00375973|O2|Outcome|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
1174115|NCT00375973|O1|Outcome|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
1174116|NCT00375973|O2|Outcome|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
1174117|NCT00375973|O1|Outcome|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
1174118|NCT00375973|O2|Outcome|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
1174119|NCT00375973|O1|Outcome|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
1174120|NCT00375973|O2|Outcome|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
1174121|NCT00375973|O1|Outcome|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
1174122|NCT00375973|O2|Outcome|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
1174123|NCT00375973|O1|Outcome|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
1174124|NCT00375973|E2|Reported Event|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
1174125|NCT00375973|E1|Reported Event|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
1174126|NCT00375934|B3|Baseline|Total|Total of all reporting groups
1174127|NCT00375934|B2|Baseline|Placebo|Oral placebo capsule, every 6 hours
1174128|NCT00375934|B1|Baseline|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
1174129|NCT00375934|P2|Participant Flow|Placebo|Oral placebo capsule, every 6 hours
1174130|NCT00375934|P1|Participant Flow|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
1174131|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
1174132|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
1174133|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
1174136|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
1174137|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
1174138|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
1174139|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
1174140|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
1174141|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
1174142|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
1174143|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
1174144|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
1174145|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
1174146|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
1174147|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
1174148|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
1174149|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
1174150|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
1174151|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
1174152|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
1174153|NCT00375934|E2|Reported Event|Placebo|Oral placebo capsule, every 6 hours
1174154|NCT00375934|E1|Reported Event|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
1174155|NCT00375752|B3|Baseline|Total|Total of all reporting groups
1174156|NCT00375752|B2|Baseline|Letrozole +Zoledronic Acid (LET+ZOL)|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
1174157|NCT00375752|B1|Baseline|Letrozole (LET)|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
1174158|NCT00375752|P2|Participant Flow|Letrozole +Zoledronic Acid (LET+ZOL)|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
1174159|NCT00375752|P1|Participant Flow|Letrozole (LET)|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
1174160|NCT00375752|O2|Outcome|Letrozole +Zoledronic Acid (LET+ZOL)|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
1174161|NCT00375752|O1|Outcome|Letrozole (LET)|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
1174162|NCT00375752|O2|Outcome|Letrozole +Zoledronic Acid (LET+ZOL)|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
1174163|NCT00375752|O1|Outcome|Letrozole (LET)|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
1174164|NCT00375752|O2|Outcome|Letrozole +Zoledronic Acid (LET+ZOL)|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
1174165|NCT00375752|O1|Outcome|Letrozole (LET)|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
1174166|NCT00375752|O2|Outcome|Letrozole +Zoledronic Acid (LET+ZOL)|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
1174167|NCT00375752|O1|Outcome|Letrozole (LET)|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
1176858|NCT00368069|O1|Outcome|Keppra®|Keppra® extended release formulation (XR)
1174168|NCT00375752|E2|Reported Event|Letrozole + Zoledronic Acid (Let + Zol)|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
1174169|NCT00375752|E1|Reported Event|Letrozole (LET)|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
1174170|NCT00375713|B3|Baseline|Total|Total of all reporting groups
1174171|NCT00375713|B2|Baseline|Cetirizine|Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
1174172|NCT00375713|B1|Baseline|Levocetirizine|Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
1174173|NCT00375713|P2|Participant Flow|Cetirizine|Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
1174174|NCT00375713|P1|Participant Flow|Levocetirizine|Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
1174175|NCT00375713|O2|Outcome|Cetirizine|Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
1174176|NCT00375713|O1|Outcome|Levocetirizine|Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
1174177|NCT00375713|O2|Outcome|Cetirizine|Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
1174178|NCT00375713|O1|Outcome|Levocetirizine|Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
1174179|NCT00375713|O2|Outcome|Cetirizine|Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
1174180|NCT00375713|O1|Outcome|Levocetirizine|Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
1174181|NCT00375713|O2|Outcome|Cetirizine|Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
1174182|NCT00375713|O1|Outcome|Levocetirizine|Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
1174183|NCT00375713|E2|Reported Event|Cetirizine|Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
1174184|NCT00375713|E1|Reported Event|Levocetirizine|Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
1174185|NCT00375505|B3|Baseline|Total|Total of all reporting groups
1174186|NCT00375505|B2|Baseline|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174187|NCT00375505|B1|Baseline|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174188|NCT00375505|P2|Participant Flow|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174189|NCT00375505|P1|Participant Flow|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174190|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174191|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174192|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174193|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174194|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174195|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174196|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174197|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174198|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174199|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174200|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174201|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174202|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174203|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174204|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174205|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174206|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174207|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174208|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174209|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174210|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174211|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1176859|NCT00368069|O2|Outcome|Placebo|placebo
1174212|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174213|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174214|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174215|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174216|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174217|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174218|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174219|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174220|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174221|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174222|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174223|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174224|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174225|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174226|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174227|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174228|NCT00375505|E2|Reported Event|Zometa|Zometa
1174229|NCT00375505|E1|Reported Event|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
1174230|NCT00375492|B3|Baseline|Total|Total of all reporting groups
1174231|NCT00375492|B2|Baseline|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
1174232|NCT00375492|B1|Baseline|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
1174233|NCT00375492|P2|Participant Flow|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
1174234|NCT00375492|P1|Participant Flow|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
1174235|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
1174236|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
1174237|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
1174238|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
1174239|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
1174240|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
1174241|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
1174242|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
1174243|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
1174244|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
1174245|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
1174246|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
1174247|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
1174248|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
1174249|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
1174250|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
1174251|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
1174252|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
1174253|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
1174254|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
1174255|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
1174256|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
1174257|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
1174258|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
1174259|NCT00375492|E2|Reported Event|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
1174615|NCT00373698|O2|Outcome|Usual Care|"Patients randomized to Usual Care will receive care as usual by VA clinicians."
1174260|NCT00375492|E1|Reported Event|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
1174261|NCT00375427|B3|Baseline|Total|Total of all reporting groups
1174262|NCT00375427|B2|Baseline|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
1174263|NCT00375427|B1|Baseline|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
1174264|NCT00375427|P2|Participant Flow|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
1174265|NCT00375427|P1|Participant Flow|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
1174266|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
1174267|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
1174268|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
1174269|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
1174270|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
1174271|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
1174272|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
1174273|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
1174274|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
1174275|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
1174276|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
1174277|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
1174278|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
1174279|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
1174280|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
1174281|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
1175360|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets twice a day (BID) plus matching placebo SC injection q 12 hours for 12 days, ± 2 days.
1174282|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
1174283|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
1174284|NCT00375427|E2|Reported Event|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions
1174285|NCT00375427|E1|Reported Event|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
1174286|NCT00375219|B4|Baseline|Total|Total of all reporting groups
1174287|NCT00375219|B3|Baseline|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174288|NCT00375219|B2|Baseline|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174358|NCT00374907|B2|Baseline|Placebo / Metformin|Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks; Metformin Tablet, Oral, 500 mg/1000 mg, once daily, starting at Week 12 and up to 104 weeks
1174359|NCT00374907|B1|Baseline|Saxagliptin 5 mg|Tablet, Oral, 5 mg, once daily, up to 12 weeks (short-term) and up to 104 weeks (long-term)
1174496|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
1174289|NCT00375219|B1|Baseline|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174290|NCT00375219|P3|Participant Flow|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174291|NCT00375219|P2|Participant Flow|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174292|NCT00375219|P1|Participant Flow|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174293|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174294|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174295|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174296|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174297|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174616|NCT00373698|O1|Outcome|Three Component Model|Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
1174298|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174299|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174300|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174301|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174360|NCT00374907|P2|Participant Flow|Placebo / Metformin|Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks; Metformin Tablet, Oral, 500 mg/1000 mg, once daily, up to 104 weeks starting at Week 12 (end of ST period). Metformin 500-1500 mg (open-label, as needed for rescue in LT).
1174497|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
1174302|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174303|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174304|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174305|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174306|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174307|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174308|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174309|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174310|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174378|NCT00374868|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
1174311|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174312|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174313|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174314|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174490|NCT00374244|P2|Participant Flow|Active Pimozide|Half of the subjects are randomized to the active drug.
1174315|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174316|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174317|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174318|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174319|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174320|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174321|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174322|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174323|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174324|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174402|NCT00374842|O3|Outcome|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1174325|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174326|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174327|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174328|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174329|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174330|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174331|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174332|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174333|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174334|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174335|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174336|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174337|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174338|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174617|NCT00373698|O2|Outcome|Arm 2/Usual Care|"Patients randomized to Usual Care will receive care as usual by VA clinicians."
1175454|NCT00371540|P1|Participant Flow|I Routine Care|Routine care in the clinic
1174339|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174340|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174341|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174342|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174343|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174344|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174345|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174346|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174347|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174348|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174349|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174350|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174351|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174352|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174403|NCT00374842|O2|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
1174353|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174354|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174355|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
1174356|NCT00375219|E1|Reported Event|Omacetaxine|Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
1174361|NCT00374907|P1|Participant Flow|Saxagliptin 5 mg|Tablet, Oral, 5 mg, once daily, up to 12 weeks (short-term) and up to 104 weeks (long-term). Metformin 500-1500 mg (open-label, as needed for rescue in LT).
1174362|NCT00374907|O2|Outcome|Placebo / Metformin|Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks; Metformin Tablet, Oral, 500 mg/1000 mg, once daily, starting at Week 12 and up to 104 weeks
1174363|NCT00374907|O1|Outcome|Saxagliptin 5 mg|Tablet, Oral, 5 mg, once daily, up to 12 weeks (short-term) and up to 104 weeks (long-term)
1174364|NCT00374907|O2|Outcome|Placebo / Metformin|Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks; Metformin Tablet, Oral, 500 mg/1000 mg, once daily, starting at Week 12 and up to 104 weeks
1174365|NCT00374907|O1|Outcome|Saxagliptin 5 mg|Tablet, Oral, 5 mg, once daily, up to 12 weeks (short-term) and up to 104 weeks (long-term)
1174366|NCT00374907|O2|Outcome|Short Term Period: Placebo|Tablet, Oral, 0 mg, once daily, up to 12 weeks
1174367|NCT00374907|O1|Outcome|Short Term Period: Saxagliptin 5 mg|Tablet, Oral, 5 mg, once daily, up to 12 weeks
1174368|NCT00374907|O2|Outcome|Short Term Period: Placebo|Tablet, Oral, 0 mg, once daily, up to 12 weeks
1174369|NCT00374907|O1|Outcome|Short Term Period: Saxagliptin 5 mg|Tablet, Oral, 5 mg, once daily, up to 12 weeks
1174370|NCT00374907|E2|Reported Event|SAXAGLIPTIN 5 MG|Tablet, Oral, 5 mg, once daily, up to 12 weeks (short term); Tablet, Oral, 5 mg, once daily, up to 104 weeks (long term)
1174371|NCT00374907|E1|Reported Event|PLACEBO/METFORMIN|Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks (short term); Metformin Tablet, Oral, 500 mg titrated to 1000 mg, once daily, up to 104 weeks (long term)
1174372|NCT00374868|B1|Baseline|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
1174373|NCT00374868|P1|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
1174374|NCT00374868|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
1174375|NCT00374868|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
1174376|NCT00374868|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
1174377|NCT00374868|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
1174430|NCT00374803|O2|Outcome|Mycophenolic Acid No Load Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
1174379|NCT00374868|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
1174380|NCT00374868|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
1174381|NCT00374868|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
1174382|NCT00374868|E1|Reported Event|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
1174383|NCT00374842|B4|Baseline|Total|Total of all reporting groups
1174384|NCT00374842|B3|Baseline|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1174385|NCT00374842|B2|Baseline|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1174386|NCT00374842|B1|Baseline|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1174498|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
1174387|NCT00374842|P3|Participant Flow|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1174388|NCT00374842|P2|Participant Flow|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1174389|NCT00374842|P1|Participant Flow|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1174390|NCT00374842|O3|Outcome|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1174391|NCT00374842|O2|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1174392|NCT00374842|O1|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
1174393|NCT00374842|O3|Outcome|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1174394|NCT00374842|O2|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1174395|NCT00374842|O1|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1174396|NCT00374842|O3|Outcome|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1174397|NCT00374842|O2|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1174398|NCT00374842|O1|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
1174399|NCT00374842|O3|Outcome|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1174400|NCT00374842|O2|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1174401|NCT00374842|O1|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
1174533|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
1174404|NCT00374842|O1|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
1174405|NCT00374842|O3|Outcome|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1174406|NCT00374842|O2|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1174407|NCT00374842|O1|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
1174408|NCT00374842|O3|Outcome|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1174409|NCT00374842|O2|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1174410|NCT00374842|O1|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
1174411|NCT00374842|O3|Outcome|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1174491|NCT00374244|P1|Participant Flow|Placebo Pimozide|Half of the subjects were randomized to placebo group.
1174492|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
1174412|NCT00374842|O2|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1174413|NCT00374842|O1|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
1174414|NCT00374842|E3|Reported Event|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
1174415|NCT00374842|E2|Reported Event|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1174416|NCT00374842|E1|Reported Event|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1174417|NCT00374803|B3|Baseline|Total|Total of all reporting groups
1174418|NCT00374803|B2|Baseline|Myfortic 720 mg Twice Daily|Myfortic 720 mg twice daily (1440 mg/day).
1174419|NCT00374803|B1|Baseline|Myfortic 1080mg BID, 720mg BID|Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
1174420|NCT00374803|P2|Participant Flow|Myfortic 720 mg Twice Daily|Myfortic 720 mg twice daily (1440 mg/day).
1174421|NCT00374803|P1|Participant Flow|Myfortic 1080mg BID, 720mg BID|Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
1174422|NCT00374803|O2|Outcome|Mycophenolic Acid No Load Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
1174423|NCT00374803|O1|Outcome|Mycophenolic Acid Loading Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
1174424|NCT00374803|O2|Outcome|Mycophenolic Acid No Load Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
1174425|NCT00374803|O1|Outcome|Mycophenolic Acid Loading Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
1174426|NCT00374803|O2|Outcome|Mycophenolic Acid No Load Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
1174427|NCT00374803|O1|Outcome|Mycophenolic Acid Loading Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
1174428|NCT00374803|O2|Outcome|Mycophenolic Acid (Myfortic) Standard|"Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day).~Mycophenolic Acid (Myfortic): • Group 1: Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter~• Group 2: Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day)."
1174429|NCT00374803|O1|Outcome|Mycophenolic Acid (Myfortic) Preload|"Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter~Mycophenolic Acid (Myfortic): • Group 1: Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter~• Group 2: Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day)."
1174534|NCT00374244|E2|Reported Event|Active Pimozide|Half of the subjects are randomized to the active drug.
1174431|NCT00374803|O1|Outcome|Mycophenolic Acid Loading Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
1174432|NCT00374803|E2|Reported Event|Mycophenolic Acid No Load Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
1174433|NCT00374803|E1|Reported Event|Mycophenolic Acid Loading Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
1174434|NCT00374543|B3|Baseline|Total|Total of all reporting groups
1174435|NCT00374543|B2|Baseline|Placebo|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Identical placebo capsules will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
1174436|NCT00374543|B1|Baseline|Ziprasidone, 40 to 160 mg/Day|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Ziprasidone will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
1174437|NCT00374543|P2|Participant Flow|Placebo|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Identical placebo capsules will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
1174438|NCT00374543|P1|Participant Flow|Ziprasidone, 40 to 160 mg/Day|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Ziprasidone will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
1174493|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
1174439|NCT00374543|O2|Outcome|Placebo|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Identical placebo capsules will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
1174440|NCT00374543|O1|Outcome|Ziprasidone, 40 to 160 mg/Day|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Ziprasidone will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
1174441|NCT00374543|E2|Reported Event|Placebo|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Identical placebo capsules will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
1174442|NCT00374543|E1|Reported Event|Ziprasidone, 40 to 160 mg/Day|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Ziprasidone will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
1174443|NCT00374335|B1|Baseline|Group 1|Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
1174444|NCT00374335|P1|Participant Flow|Group 1|Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
1174445|NCT00374335|O1|Outcome|Group 1|Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
1174446|NCT00374335|O1|Outcome|Group 1|Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
1174447|NCT00374335|E1|Reported Event|Group 1|Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
1174448|NCT00374322|B3|Baseline|Total|Total of all reporting groups
1174449|NCT00374322|B2|Baseline|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174450|NCT00374322|B1|Baseline|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174451|NCT00374322|P2|Participant Flow|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174452|NCT00374322|P1|Participant Flow|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174453|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174454|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174455|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174456|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174457|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174535|NCT00374244|E1|Reported Event|Placebo Pimozide|Half of the subjects were randomized to placebo group.
1174458|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174459|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174460|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174461|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174462|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174463|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174464|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174494|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
1174465|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174466|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174467|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal
1174468|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174469|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174470|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174471|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174472|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174473|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174474|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174475|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174476|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174477|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174478|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174479|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174480|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1175455|NCT00371540|O2|Outcome|II Home Visits|
1174481|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174482|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174483|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174484|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174485|NCT00374322|E2|Reported Event|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174486|NCT00374322|E1|Reported Event|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
1174487|NCT00374244|B3|Baseline|Total|Total of all reporting groups
1174488|NCT00374244|B2|Baseline|Active Pimozide|Half of the subjects are randomized to the active drug.
1174489|NCT00374244|B1|Baseline|Placebo Pimozide|Half of the subjects were randomized to placebo group.
1174499|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
1174500|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
1174501|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
1174502|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
1174503|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
1174504|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
1174505|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
1174506|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
1174507|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
1174508|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
1174509|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
1174510|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
1174511|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
1174512|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
1174513|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
1174514|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
1174515|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
1174516|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
1174517|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
1174518|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
1174519|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
1174520|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
1174521|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
1174522|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
1174523|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
1174524|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
1174525|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
1174526|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
1174527|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
1174528|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
1174529|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
1174530|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
1174531|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
1174532|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
1174536|NCT00374231|B1|Baseline|Tacrolimus and Mycophenolate Mofetil|"All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short coarse of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days.~tacrolimus : Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.~mycophenolate mofetil : Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis."
1174537|NCT00374231|P1|Participant Flow|Corticosteroid Withdrawal|Discontinue prednisone at 90 days or longer post liver transplant if rejection free previous 30 days.
1174538|NCT00374231|O1|Outcome|Corticosteroid Withdrawal|"All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short coarse of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days.~tacrolimus: Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.~mycophenolate mofetil: Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis."
1174539|NCT00374231|O1|Outcome|Corticosteroid Withdrawal|"All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short coarse of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days.~tacrolimus: Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.~mycophenolate mofetil: Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis."
1174540|NCT00374231|O1|Outcome|Corticosteroid Withdrawa.|"All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short coarse of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days.~tacrolimus: Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.~mycophenolate mofetil: Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis."
1174570|NCT00373958|O2|Outcome|7vPnC After Infant Series|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
1174636|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
1174541|NCT00374231|E1|Reported Event|Tacrolimus and Mycophenolate Mofetil|"All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short coarse of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days.~tacrolimus : Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.~mycophenolate mofetil : Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis."
1174542|NCT00374140|B1|Baseline|RAD001 (Everolimus)|RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
1174543|NCT00374140|P1|Participant Flow|RAD001 (Everolimus)|RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
1174544|NCT00374140|O1|Outcome|RAD001 (Everolimus)|RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
1174545|NCT00374140|E1|Reported Event|RAD001 (Everolimus)|RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
1174546|NCT00374088|B3|Baseline|Total|Total of all reporting groups
1174547|NCT00374088|B2|Baseline|N-acetylcysteine|Patients treated with N-acetylcysteine
1174548|NCT00374088|B1|Baseline|Placebo|Patients not treated with N-acetylcysteine
1174549|NCT00374088|P2|Participant Flow|N-acetylcysteine|Patients treated with N-acetylcysteine
1174550|NCT00374088|P1|Participant Flow|Placebo|Patients not treated with N-acetylcysteine
1174551|NCT00374088|O2|Outcome|N-acetylcysteine|Patients treated with N-acetylcysteine
1174552|NCT00374088|O1|Outcome|Placebo|Patients not treated with N-acetylcysteine
1174553|NCT00374088|O2|Outcome|N-acetylcysteine|Patients treated with N-acetylcysteine
1174554|NCT00374088|O1|Outcome|Placebo|Patients not treated with N-acetylcysteine
1174555|NCT00374088|O2|Outcome|N-acetylcysteine|Patients treated with N-acetylcysteine
1174556|NCT00374088|O1|Outcome|Placebo|Patients not treated with N-acetylcysteine
1174557|NCT00374088|E2|Reported Event|N-acetylcysteine|Patients treated with N-acetylcysteine
1174558|NCT00374088|E1|Reported Event|Placebo|Patients not treated with N-acetylcysteine
1174559|NCT00373958|B3|Baseline|Total|Total of all reporting groups
1174560|NCT00373958|B2|Baseline|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
1174561|NCT00373958|B1|Baseline|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
1174583|NCT00373958|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
1174562|NCT00373958|P2|Participant Flow|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
1174563|NCT00373958|P1|Participant Flow|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
1174564|NCT00373958|O4|Outcome|7vPnC After the Toddler Dose|Subjects received 1 single 0.5 mL dose of 7vPnC coadministered with Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
1174565|NCT00373958|O3|Outcome|13vPnC After the Toddler Dose|Subjects received 1 single 0.5 mL dose of 13vPnC coadministered with Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
1174566|NCT00373958|O2|Outcome|7vPnC After the Infant Series|Subjects received 1 single 0.5 mL dose of 7vPnC coadministered with Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
1174567|NCT00373958|O1|Outcome|13vPnC After the Infant Series|Subjects received 1 single 0.5 mL dose of 13vPnC coadministered with Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
1174568|NCT00373958|O4|Outcome|7vPnC After Toddler Dose|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
1174569|NCT00373958|O3|Outcome|13vPnC After Toddler Dose|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
1174571|NCT00373958|O1|Outcome|13vPnC After Infant Series|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
1174572|NCT00373958|O8|Outcome|7vPnC Toddler Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
1174573|NCT00373958|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
1174574|NCT00373958|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
1174575|NCT00373958|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
1174576|NCT00373958|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
1174577|NCT00373958|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
1174578|NCT00373958|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
1174579|NCT00373958|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
1174580|NCT00373958|O8|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
1174581|NCT00373958|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
1174582|NCT00373958|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
1174584|NCT00373958|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
1174585|NCT00373958|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
1174586|NCT00373958|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
1174587|NCT00373958|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
1174588|NCT00373958|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
1174589|NCT00373958|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
1174633|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
1174634|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
1174590|NCT00373958|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
1174591|NCT00373958|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
1174592|NCT00373958|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
1174593|NCT00373958|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
1174594|NCT00373958|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
1174595|NCT00373958|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
1174596|NCT00373958|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
1175456|NCT00371540|O1|Outcome|I Rountine Care|
1174597|NCT00373958|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
1174598|NCT00373958|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
1174599|NCT00373958|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
1174600|NCT00373958|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
1174635|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
1174672|NCT00373490|B3|Baseline|Total|Total of all reporting groups
1174601|NCT00373958|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
1174602|NCT00373958|E8|Reported Event|7vPnC 6-Month Follow-up|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
1174603|NCT00373958|E7|Reported Event|13vPnC 6-Month Follow-up|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
1174604|NCT00373958|E6|Reported Event|7vPnC Toddler Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
1174605|NCT00373958|E5|Reported Event|13vPnC Toddler Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
1174606|NCT00373958|E4|Reported Event|7vPnC Post Infant Series|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
1174607|NCT00373958|E3|Reported Event|13vPnC Post Infant Series|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
1174608|NCT00373958|E2|Reported Event|7vPnC Infant Series|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
1174609|NCT00373958|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
1174610|NCT00373698|B3|Baseline|Total|Total of all reporting groups
1174611|NCT00373698|B2|Baseline|Usual Care|"Patients randomized to Usual Care will receive care as usual by VA clinicians."
1174612|NCT00373698|B1|Baseline|Three Component Model|Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
1174613|NCT00373698|P2|Participant Flow|Usual Care|"Participants randomized to Usual Care received care at the VA provider's discretion and could include referral to mental health specialty care."
1174614|NCT00373698|P1|Participant Flow|Three Component Model of Collaborative Care and Usual Care|"Participants randomized to this arm received the Three Component Model of Collaborative Care (3CM) as well as usual care. 3CM model consists of 1) education and tools for primary care clinicians and staff including content regarding PTSD; 2) telephone care management by a centrally located care manager (the purpose of the calls was to identify barriers to adherance with the primary care provider's plan, aid participant to overcome them, and measure treatment response. Calls occurred 1, 4, and 8 weeks after the initial visit and then every 4 weeks for 6 months or until a participant acheived 30% reduction in PTSD symptoms as measure by the PCL); 3) support from a psychiatrist who supervises care managers by telephone, provides consultation to primary care clinicians, and facilitates mental health referral. Participant's Usual Care is at the VA provider's discretion and could include referral to mental health specialty care.specialty care."
1174618|NCT00373698|O1|Outcome|Arm1/Three Component Model of Care Collaborative Care|Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
1174619|NCT00373698|O2|Outcome|Arm 2/Usual Care|"Patients randomized to Usual Care will receive care as usual by VA clinicians."
1174620|NCT00373698|O1|Outcome|Arm1/Three Component Model of Care Collaborative Care|Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
1174621|NCT00373698|O2|Outcome|Arm 2/Usual Care|"Patients randomized to Usual Care will receive care as usual by VA clinicians."
1174622|NCT00373698|O1|Outcome|Arm1/Three Component Model of Care Collaborative Care|Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
1174623|NCT00373698|E2|Reported Event|Usual Care|"Patients randomized to Usual Care will receive care as usual by VA clinicians."
1174624|NCT00373698|E1|Reported Event|Three Component Model|Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
1174625|NCT00373685|B3|Baseline|Total|Total of all reporting groups
1174626|NCT00373685|B2|Baseline|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
1174627|NCT00373685|B1|Baseline|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
1174628|NCT00373685|P2|Participant Flow|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
1174629|NCT00373685|P1|Participant Flow|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
1174630|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
1174631|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
1174632|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
1174637|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
1174638|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
1174639|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
1174640|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
1174641|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
1174642|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
1174643|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
1174644|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
1174645|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
1174646|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
1174647|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
1174648|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
1174649|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
1174650|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
1174651|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
1174652|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
1174653|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
1174654|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
1174655|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
1174656|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
1174657|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
1174658|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
1174659|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
1174660|NCT00373685|E2|Reported Event|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
1174661|NCT00373685|E1|Reported Event|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
1175457|NCT00371540|O2|Outcome|II Home Visits|
1175458|NCT00371540|O1|Outcome|I Rountine Care|
1174662|NCT00373529|B1|Baseline|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
1174663|NCT00373529|P1|Participant Flow|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
1174664|NCT00373529|O1|Outcome|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
1174665|NCT00373529|O1|Outcome|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
1174666|NCT00373529|O1|Outcome|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
1174667|NCT00373529|O1|Outcome|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
1174668|NCT00373529|O1|Outcome|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
1174669|NCT00373529|O1|Outcome|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
1174670|NCT00373529|O1|Outcome|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
1174671|NCT00373529|E1|Reported Event|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
1174673|NCT00373490|B2|Baseline|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
1174674|NCT00373490|B1|Baseline|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
1174675|NCT00373490|P2|Participant Flow|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
1174676|NCT00373490|P1|Participant Flow|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
1174677|NCT00373490|O2|Outcome|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
1174678|NCT00373490|O1|Outcome|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
1174679|NCT00373490|O2|Outcome|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
1174680|NCT00373490|O1|Outcome|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
1174681|NCT00373490|O2|Outcome|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
1174682|NCT00373490|O1|Outcome|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
1174683|NCT00373490|O2|Outcome|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
1174684|NCT00373490|O1|Outcome|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
1174685|NCT00373490|O2|Outcome|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
1174686|NCT00373490|O1|Outcome|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
1174687|NCT00373490|O2|Outcome|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
1174688|NCT00373490|O1|Outcome|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
1174689|NCT00373490|O2|Outcome|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
1174690|NCT00373490|O1|Outcome|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
1174691|NCT00373490|E2|Reported Event|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
1174692|NCT00373490|E1|Reported Event|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
1174693|NCT00373425|B6|Baseline|Total|Total of all reporting groups
1174694|NCT00373425|B5|Baseline|BPC-OLC: Erlotinib|The BPC open-label cohort (BPC-OLC) includes participants randomized prior to 07 November 2007 who received at least 1 dose of study drug after being randomized, who entered the open-label erlotinib period. Data presented for the BPC-OLC included data from both the blinded period and the open-label erlotinib period.
1174695|NCT00373425|B4|Baseline|BPC-NOLC: Placebo Only|The BPC no open-label cohort (BPC-NOLC) includes participants randomized prior to 07 November 2007 who did not participate in the open-label erlotinib period and who were previously randomized to receive either erlotinib or placebo in the blinded period, and did not receive any erlotinib.
1174696|NCT00373425|B3|Baseline|BPC-NOLC: Erlotinib/Placebo|The BPC no open-label cohort (BPC-NOLC) includes participants randomized prior to 07 November 2007 who did not participate in the open-label erlotinib period and who were previously randomized to receive either erlotinib or placebo in the blinded period, and received at least one dose of erlotinib.
1174697|NCT00373425|B2|Baseline|RC: Placebo|Participants in the randomized cohort (RC) who received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
1174698|NCT00373425|B1|Baseline|RC: Erlotinib|Participants in the randomized cohort (RC) who received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
1174699|NCT00373425|P5|Participant Flow|BPC-OLC: Erlotinib|The BPC open-label cohort (BPC-OLC) includes participants randomized prior to 07 November 2007 who received at least 1 dose of study drug after being randomized, who entered the open-label erlotinib period. Data presented for the BPC-OLC included data from both the blinded period and the open-label erlotinib period.
1174700|NCT00373425|P4|Participant Flow|BPC-NOLC: Placebo Only|The BPC no open-label cohort (BPC-NOLC) includes participants randomized prior to 07 November 2007 who did not participate in the open-label erlotinib period and who were previously randomized to receive either erlotinib or placebo in the blinded period, and did not receive any erlotinib.
1174701|NCT00373425|P3|Participant Flow|BPC-NOLC: Erlotinib/Placebo|The BPC no open-label cohort (BPC-NOLC) includes participants randomized prior to 07 November 2007 who did not participate in the open-label erlotinib period and who were previously randomized to receive either erlotinib or placebo in the blinded period, and received at least one dose of erlotinib.
1174702|NCT00373425|P2|Participant Flow|RC: Placebo|Participants in the randomized cohort (RC) who received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
1174703|NCT00373425|P1|Participant Flow|RC: Erlotinib|Participants in the randomized cohort (RC) who received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
1174704|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
1174705|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
1174706|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
1174742|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
1174707|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
1174708|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
1174709|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
1174710|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
1174711|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
1174712|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
1174713|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
1174714|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
1174715|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
1174716|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
1174717|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
1174718|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
1174719|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
1174720|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
1174721|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
1174722|NCT00373425|E5|Reported Event|BPC-OLC: Erlotinib|The BPC open-label cohort (BPC-OLC) includes participants randomized prior to 07 November 2007 who received at least 1 dose of study drug after being randomized, who entered the open-label erlotinib period. Data presented for the BPC-OLC included data from both the blinded period and the open-label erlotinib period.
1174777|NCT00373295|P4|Participant Flow|Baclofen 90 mg, Baclofen 60 mg, Placebo|participants received baclofen (90mg/day) for 8 days, followed by baclofen (60mg/day) for 8 days, and then placebo for 8 days.
1174723|NCT00373425|E4|Reported Event|BPC-NOLC: Placebo Only|The BPC no open-label cohort (BPC-NOLC) includes participants randomized prior to 07 November 2007 who did not participate in the open-label erlotinib period and who were previously randomized to receive either erlotinib or placebo in the blinded period, and did not receive any erlotinib.
1174724|NCT00373425|E3|Reported Event|BPC-NOLC: Erlotinib/Placebo|The BPC no open-label cohort (BPC-NOLC) includes participants randomized prior to 07 November 2007 who did not participate in the open-label erlotinib period and who were previously randomized to receive either erlotinib or placebo in the blinded period, and received at least one dose of erlotinib.
1174725|NCT00373425|E2|Reported Event|RC: Placebo|Participants in the randomized cohort (RC) who received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
1174726|NCT00373425|E1|Reported Event|RC: Erlotinib|Participants in the randomized cohort (RC) who received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
1174727|NCT00373360|B1|Baseline|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
1174728|NCT00373360|P1|Participant Flow|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
1174729|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
1174730|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
1174731|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
1174732|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
1174733|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
1174734|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
1174735|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
1174736|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
1174737|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
1174738|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
1174739|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
1174740|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
1174741|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
1178724|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
1174743|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
1174744|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
1174745|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
1174746|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
1174747|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
1174748|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
1174749|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
1174750|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
1174751|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
1174752|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
1174753|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
1174754|NCT00373360|E1|Reported Event|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
1174755|NCT00373334|B4|Baseline|Total|Total of all reporting groups
1174756|NCT00373334|B3|Baseline|Conservative Measures Only|
1174757|NCT00373334|B2|Baseline|Nizatidine 5.0 mg/kg b.i.d.|
1174758|NCT00373334|B1|Baseline|Nizatidine 2.5 mg/kg b.i.d.|
1174759|NCT00373334|P3|Participant Flow|Placebo|"Placebo plus Conservative Measures~Conservative Measures included:~Hypoallergenic formula thickened with dry rice cereal Avoidance of seated and supine positioning Elimination of tobacco smoke exposure"
1174760|NCT00373334|P2|Participant Flow|Nizatidine 5.0 mg/kg Twice Daily|high dose nizatidine plus Conservative Measures
1174761|NCT00373334|P1|Participant Flow|Nizatidine 2.5 mg/kg Twice Daily|low dose nizatidine plus Conservative Measures
1174762|NCT00373334|O3|Outcome|Conservative Measures Only|
1174763|NCT00373334|O2|Outcome|Nizatidine 5.0 mg/kg b.i.d.|
1174764|NCT00373334|O1|Outcome|Nizatidine 2.5 mg/kg b.i.d.|
1174765|NCT00373334|O3|Outcome|Conservative Measures Only|
1174766|NCT00373334|O2|Outcome|Nizatidine 5.0 mg/kg b.i.d.|
1174767|NCT00373334|O1|Outcome|Nizatidine 2.5 mg/kg b.i.d.|
1174768|NCT00373334|O3|Outcome|Conservative Measures Only|
1174769|NCT00373334|O2|Outcome|Nizatidine 5.0 mg/kg b.i.d.|
1174770|NCT00373334|O1|Outcome|Nizatidine 2.5 mg/kg b.i.d.|
1174771|NCT00373334|E3|Reported Event|Conservative Measures Only|
1174772|NCT00373334|E2|Reported Event|Nizatidine 5.0 mg/kg b.i.d.|
1174773|NCT00373334|E1|Reported Event|Nizatidine 2.5 mg/kg b.i.d.|
1174774|NCT00373295|B1|Baseline|All Study Participants|Participants received placebo, baclofen (60mg) and baclofen (90mg) and smoked Marijuana (5.3% THC).
1174775|NCT00373295|P6|Participant Flow|Placebo, Baclofen 60 mg, Baclofen 90 mg|participants received placebo for 8 days, followed by baclofen (60mg/day) for 8 days, then baclofen (90mg/day) for 8 days.
1174776|NCT00373295|P5|Participant Flow|Placebo, Baclofen 90 mg, Baclofen 60 mg|participants received placebo for 8 days, followed by baclofen (90mg/day) for 8 days, then baclofen (60mg/day) for 8 days.
1175459|NCT00371540|O2|Outcome|II Home Visits|
1175460|NCT00371540|O1|Outcome|I Rountine Care|
1174778|NCT00373295|P3|Participant Flow|Baclofen 60 mg, Baclofen 90 mg, Placebo|participants received baclofen (60mg/day) for 8 days, followed by baclofen (90mg/day) for 8 days, then placebo for 8 days.
1174779|NCT00373295|P2|Participant Flow|Baclofen 90 mg, Placebo, Baclofen 60 mg|participants received baclofen (90mg/day) for 8 days, followed by placebo for 8 days, then baclofen (60mg/day) for 8 days.
1174780|NCT00373295|P1|Participant Flow|Baclofen 60 mg, Placebo, Baclofen 90 mg|participants received baclofen (60 mg/day) for 8 days, followed by placebo for 8 days, then baclofen (90mg/day) for 8 days.
1174781|NCT00373295|O3|Outcome|Baclofen 90, Marijuana|"baclofen (90 mg)/day~Baclofen: measured baclofen's effects on marijuana withdrawal and relapse relative to placebo~Marijuana: measured baclofen's effects on marijuana withdrawal and relapse"
1174782|NCT00373295|O2|Outcome|Placebo, Marijuana|
1174783|NCT00373295|O1|Outcome|Baclofen 60, Marijuana|"baclofen (60 mg)/day~Baclofen: measured baclofen's effects on marijuana withdrawal and relapse relative to placebo~Marijuana: measured baclofen's effects on marijuana withdrawal and relapse"
1174784|NCT00373295|E3|Reported Event|Placebo, Marijuana|Marijuana: measured baclofen's effects on marijuana withdrawal and relapse
1174785|NCT00373295|E2|Reported Event|Baclofen 90, Marijuana|"baclofen (90 mg)/day~Baclofen: measured baclofen's effects on marijuana withdrawal and relapse relative to placebo~Marijuana: measured baclofen's effects on marijuana withdrawal and relapse"
1174786|NCT00373295|E1|Reported Event|Baclofen 60, Marijuana|"baclofen (60 mg)/day~Baclofen: measured baclofen's effects on marijuana withdrawal and relapse relative to placebo~Marijuana: measured baclofen's effects on marijuana withdrawal and relapse"
1174787|NCT00373269|B3|Baseline|Total|Total of all reporting groups
1174788|NCT00373269|B2|Baseline|Hyperglycemic|Subjects with acute ischemic stroke and hyperglycemia.
1174789|NCT00373269|B1|Baseline|Normoglycemic|Subjects with acute ischemic stroke and normal blood glucose.
1174790|NCT00373269|P2|Participant Flow|Hyperglycemic Subjects|Subjects with acute ischemic stroke and hyperglycemia.
1174791|NCT00373269|P1|Participant Flow|Normoglycemic Control|Subjects with acute ischemic stroke and normal blood glucose.
1174792|NCT00373269|O2|Outcome|Hyperglycemic Subjects|Subjects with acute ischemic stroke and hyperglycemia.
1174793|NCT00373269|O1|Outcome|Normoglycemic Control|Subjects with acute ischemic stroke and normal blood glucose.
1174794|NCT00373269|O2|Outcome|Hyperglycemic Subjects|Subjects with acute ischemic stroke and hyperglycemia.
1174795|NCT00373269|O1|Outcome|Normoglycemic Control|Subjects with acute ischemic stroke and normal blood glucose.
1174796|NCT00373269|E2|Reported Event|Normoglycemic Control|Subjects with acute stroke and normal blood glucose.
1174797|NCT00373269|E1|Reported Event|Diabetic Subject|Subjects with acute stroke, hyperglycemia and history of diabetes.
1174798|NCT00373256|B3|Baseline|Total|Total of all reporting groups
1174799|NCT00373256|B2|Baseline|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
1174800|NCT00373256|B1|Baseline|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
1174801|NCT00373256|P2|Participant Flow|Bevacizumab + Paclitaxel|Bevacizumab 10 milligrams per kilogram (mg/kg); infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
1174802|NCT00373256|P1|Participant Flow|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 milligrams (mg) daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 milligrams per square meter (mg/m^2), at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
1174803|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
1174804|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
1174805|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
1174806|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
1174807|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
1174808|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
1174834|NCT00373113|O2|Outcome|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
1174809|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
1174810|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
1174811|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
1174812|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
1174813|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
1174814|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
1174815|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
1174816|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
1174817|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
1174818|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
1174819|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
1174820|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
1174821|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
1174822|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
1174823|NCT00373256|E2|Reported Event|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
1174824|NCT00373256|E1|Reported Event|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
1174825|NCT00373113|B3|Baseline|Total|Total of all reporting groups
1174826|NCT00373113|B2|Baseline|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
1174827|NCT00373113|B1|Baseline|Sunitinib|37.5 mg daily, continuous dosing
1174828|NCT00373113|P2|Participant Flow|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
1174829|NCT00373113|P1|Participant Flow|Sunitinib|37.5 milligrams (mg) daily, continuous dosing
1174830|NCT00373113|O2|Outcome|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
1174831|NCT00373113|O1|Outcome|Sunitinib|37.5 mg daily, continuous dosing
1174832|NCT00373113|O2|Outcome|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
1174833|NCT00373113|O1|Outcome|Sunitinib|37.5 mg daily, continuous dosing
1174836|NCT00373113|O2|Outcome|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
1174837|NCT00373113|O1|Outcome|Sunitinib|37.5 mg daily, continuous dosing
1174838|NCT00373113|O2|Outcome|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
1174839|NCT00373113|O1|Outcome|Sunitinib|37.5 mg daily, continuous dosing
1174840|NCT00373113|O2|Outcome|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
1174841|NCT00373113|O1|Outcome|Sunitinib|37.5 mg daily, continuous dosing
1174842|NCT00373113|O2|Outcome|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
1174843|NCT00373113|O1|Outcome|Sunitinib|37.5 mg daily, continuous dosing
1174844|NCT00373113|O2|Outcome|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
1174845|NCT00373113|O1|Outcome|Sunitinib|37.5 mg daily, continuous dosing
1174846|NCT00373113|E2|Reported Event|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
1174847|NCT00373113|E1|Reported Event|Sunitinib|37.5 mg daily, continuous dosing
1174848|NCT00372996|B3|Baseline|Total|Total of all reporting groups
1174849|NCT00372996|B2|Baseline|Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression could have received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 3-week cycle in combination with exemestane 25 mg tablets, by mouth, once daily, for up to a total of 20 months or beyond if safety and clinical benefit were observed.
1174850|NCT00372996|B1|Baseline|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression could have received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 4-week cycle in combination with fulvestrant, administered according to the local label and standard clinical practice. Participants continued salvage treatment if safety and clinical benefit were observed for up to a total of 26 cycles or beyond, if there was continued clinical benefit, safety, and tolerability.
1174879|NCT00372970|B1|Baseline|Botulinum Toxin|Received 200U of Botox injected into pyloric sphincter endoscopically.
1178725|NCT00362414|O1|Outcome|Two Growth Factors|double growth factors
1174851|NCT00372996|P4|Participant Flow|Exemestane/CP-751,871 + Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 3-week cycle in combination with exemestane 25 mg tablets, by mouth, once daily, for up to a total of 20 months or beyond if safety and clinical benefit were observed.
1174852|NCT00372996|P3|Participant Flow|Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression.
1174853|NCT00372996|P2|Participant Flow|CP-751,871 + Exemestane/CP-751,871 + Fulvestrant|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 4-week cycle in combination with fulvestrant, administered according to the local label and standard clinical practice. Participants continued salvage treatment if safety and clinical benefit were observed for up to a total of 26 cycles or beyond, if there was continued clinical benefit, safety, and tolerability.
1174854|NCT00372996|P1|Participant Flow|CP-751,871 Plus (+) Exemestane|Participants received CP-751,871 20 milligrams per kilogram (mg/kg) on Day 1 of each 3-week cycle as an intravenous (IV) infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
1174855|NCT00372996|O2|Outcome|Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression.
1174856|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
1174857|NCT00372996|O2|Outcome|Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression.
1174858|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
1174859|NCT00372996|O2|Outcome|Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression.
1174860|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
1174861|NCT00372996|O2|Outcome|Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression.
1174862|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
1174863|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
1174864|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
1174865|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
1174866|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
1174867|NCT00372996|O2|Outcome|Exemestane|Participants were assigned to receive exemestane 25 mg tablets, by mouth, once daily, until disease progression.
1174868|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants were assigned to receive CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
1174869|NCT00372996|O2|Outcome|Exemestane|Participants were assigned to receive exemestane 25 mg tablets, by mouth, once daily, until disease progression.
1174870|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants were assigned to receive CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
1174871|NCT00372996|O2|Outcome|Exemestane|Participants were assigned to receive exemestane 25 mg tablets, by mouth, once daily, until disease progression.
1174872|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants were assigned to receive CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
1174873|NCT00372996|E4|Reported Event|CP-751,871 + Exemestane (After Exemestane)|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 3-week cycle in combination with exemestane 25 mg tablets, by mouth, once daily, for up to a total of 20 months or beyond if safety and clinical benefit were observed. Adverse events are presented from the period of time when the participant was receiving salvage therapy treatment only.
1174874|NCT00372996|E3|Reported Event|Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression.
1174875|NCT00372996|E2|Reported Event|CP-751,871 + Fulvestrant (After CP-751,871+Exemestane)|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 4-week cycle in combination with fulvestrant, administered according to the local label and standard clinical practice. Participants continued salvage treatment if safety and clinical benefit were observed for up to a total of 26 cycles or beyond, if there was continued clinical benefit, safety, and tolerability. Adverse events are presented from the period of time when the participant was receiving salvage therapy treatment only.
1174876|NCT00372996|E1|Reported Event|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
1174877|NCT00372970|B3|Baseline|Total|Total of all reporting groups
1174878|NCT00372970|B2|Baseline|Placebo|Received 5 cc saline injected into pyloric sphincter endoscopically.
1179593|NCT00360529|O1|Outcome|Placebo|placebo at bedtime
1174880|NCT00372970|P2|Participant Flow|Placebo|Received 5 cc saline injected into pyloric sphincter endoscopically.
1174881|NCT00372970|P1|Participant Flow|Botulinum Toxin|Received 200U of Botox injected into pyloric sphincter endoscopically.
1174882|NCT00372970|O2|Outcome|Placebo|saline Injection into pylorus
1174883|NCT00372970|O1|Outcome|Botox|Botox injection into pylorus
1174884|NCT00372970|E2|Reported Event|Placebo|saline Injection into pylorus
1174885|NCT00372970|E1|Reported Event|Botox|Botox injection into pylorus
1174886|NCT00372775|B1|Baseline|Sunitinib|Sunitinib 37.5 mg oral capsule daily
1174887|NCT00372775|P1|Participant Flow|Sunitinib|Sunitinib 37.5 mg oral capsule daily
1174888|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
1174889|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
1174890|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
1174891|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
1174892|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
1174893|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
1174894|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
1174895|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
1174896|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
1174897|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
1174898|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
1174899|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
1174900|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
1174901|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
1174902|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
1174903|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
1174904|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
1174905|NCT00372775|E1|Reported Event|Sunitinib|Sunitinib 37.5 mg oral capsule daily
1174906|NCT00372697|B3|Baseline|Total|Total of all reporting groups
1174907|NCT00372697|B2|Baseline|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
1174908|NCT00372697|B1|Baseline|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
1175013|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
1174909|NCT00372697|P2|Participant Flow|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
1174910|NCT00372697|P1|Participant Flow|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
1174911|NCT00372697|O2|Outcome|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
1174912|NCT00372697|O1|Outcome|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
1174913|NCT00372697|O2|Outcome|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
1175024|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
1174914|NCT00372697|O1|Outcome|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
1174915|NCT00372697|O2|Outcome|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
1174916|NCT00372697|O1|Outcome|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
1174917|NCT00372697|O2|Outcome|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
1174918|NCT00372697|O1|Outcome|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
1174919|NCT00372697|O2|Outcome|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
1174920|NCT00372697|O1|Outcome|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
1174921|NCT00372697|O2|Outcome|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
1174922|NCT00372697|O1|Outcome|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
1174923|NCT00372697|O2|Outcome|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
1174924|NCT00372697|O1|Outcome|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
1174925|NCT00372697|E2|Reported Event|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
1174926|NCT00372697|E1|Reported Event|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
1174927|NCT00372619|B8|Baseline|Total|Total of all reporting groups
1174928|NCT00372619|B7|Baseline|Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt|"Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174929|NCT00372619|B6|Baseline|Clofarabine 52 mg/m² to Assess Efficacy in AML Patients|"Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174930|NCT00372619|B5|Baseline|Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174931|NCT00372619|B4|Baseline|Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.|"Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174932|NCT00372619|B3|Baseline|Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174933|NCT00372619|B2|Baseline|Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174934|NCT00372619|B1|Baseline|Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1175025|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
1175679|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
1174935|NCT00372619|P7|Participant Flow|Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt|"Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174936|NCT00372619|P6|Participant Flow|Clofarabine 52 mg/m² to Assess Efficacy in AML Patients|"Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174937|NCT00372619|P5|Participant Flow|Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174938|NCT00372619|P4|Participant Flow|Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.|"Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174939|NCT00372619|P3|Participant Flow|Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1175461|NCT00371540|E2|Reported Event|II Home Visits|
1174940|NCT00372619|P2|Participant Flow|Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174941|NCT00372619|P1|Participant Flow|Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174942|NCT00372619|O7|Outcome|Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt|"Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174943|NCT00372619|O6|Outcome|Clofarabine 52 mg/m² to Assess Efficacy in AML Patients|"Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174944|NCT00372619|O5|Outcome|Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174945|NCT00372619|O4|Outcome|Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.|"Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174946|NCT00372619|O3|Outcome|Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174947|NCT00372619|O2|Outcome|Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1175014|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
1174948|NCT00372619|O1|Outcome|Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174949|NCT00372619|O7|Outcome|Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt|"Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174950|NCT00372619|O6|Outcome|Clofarabine 52 mg/m² to Assess Efficacy in AML Patients|"Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174951|NCT00372619|O5|Outcome|Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174952|NCT00372619|O4|Outcome|Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.|"Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174953|NCT00372619|O3|Outcome|Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174954|NCT00372619|O2|Outcome|Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174955|NCT00372619|O1|Outcome|Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1175076|NCT00372411|E3|Reported Event|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
1174956|NCT00372619|O7|Outcome|Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt|"Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174957|NCT00372619|O6|Outcome|Clofarabine 52 mg/m² to Assess Efficacy in AML Patients|"Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174958|NCT00372619|O5|Outcome|Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174959|NCT00372619|O4|Outcome|Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.|"Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174960|NCT00372619|O3|Outcome|Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174961|NCT00372619|O2|Outcome|Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174962|NCT00372619|O1|Outcome|Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174963|NCT00372619|E7|Reported Event|Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt|"Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1175462|NCT00371540|E1|Reported Event|I Rountine Care|
1175463|NCT00371462|B3|Baseline|Total|Total of all reporting groups
1174964|NCT00372619|E6|Reported Event|Clofarabine 52 mg/m² to Assess Efficacy in AML Patients|"Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174965|NCT00372619|E5|Reported Event|Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174966|NCT00372619|E4|Reported Event|Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.|"Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174967|NCT00372619|E3|Reported Event|Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174968|NCT00372619|E2|Reported Event|Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174969|NCT00372619|E1|Reported Event|Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
1174970|NCT00372593|B4|Baseline|Total|Total of all reporting groups
1174971|NCT00372593|B3|Baseline|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
1174979|NCT00372593|O1|Outcome|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
1174972|NCT00372593|B2|Baseline|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
1174973|NCT00372593|B1|Baseline|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
1175026|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
1175027|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
1175028|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
1175314|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
1174974|NCT00372593|P3|Participant Flow|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
1174975|NCT00372593|P2|Participant Flow|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
1174976|NCT00372593|P1|Participant Flow|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
1174977|NCT00372593|O3|Outcome|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
1174978|NCT00372593|O2|Outcome|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
1175005|NCT00372567|P3|Participant Flow|Sunitinib (Phase 1)|Single 37.5 mg dose administered 24 hours after the last dose of imatinib
1175006|NCT00372567|P2|Participant Flow|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
1175007|NCT00372567|P1|Participant Flow|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
1174980|NCT00372593|O3|Outcome|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
1174981|NCT00372593|O2|Outcome|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
1174982|NCT00372593|O1|Outcome|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
1174983|NCT00372593|O3|Outcome|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
1174984|NCT00372593|O2|Outcome|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
1174985|NCT00372593|O1|Outcome|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
1174986|NCT00372593|O3|Outcome|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
1175008|NCT00372567|O1|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
1175009|NCT00372567|O1|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
1175010|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
1183688|NCT00349908|O2|Outcome|Group 2|Aneurysm Arm
1174987|NCT00372593|O2|Outcome|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
1174988|NCT00372593|O1|Outcome|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
1174989|NCT00372593|O3|Outcome|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
1174990|NCT00372593|O2|Outcome|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
1174991|NCT00372593|O1|Outcome|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
1174992|NCT00372593|O3|Outcome|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
1174993|NCT00372593|O2|Outcome|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
1175011|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
1175012|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
1175585|NCT00371293|O1|Outcome|CPAP - Adherent|"Participants will receive CPAP therapy.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
1174994|NCT00372593|O1|Outcome|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
1174995|NCT00372593|O3|Outcome|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
1182382|NCT00352885|B3|Baseline|Total|Total of all reporting groups
1174996|NCT00372593|O2|Outcome|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
1174997|NCT00372593|O1|Outcome|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
1174998|NCT00372593|E3|Reported Event|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
1174999|NCT00372593|E2|Reported Event|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
1175000|NCT00372593|E1|Reported Event|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
1175001|NCT00372567|B4|Baseline|Total|Total of all reporting groups
1175002|NCT00372567|B3|Baseline|Sunitinib (Phase 1)|Single 37.5 mg dose administered 24 hours after the last dose of imatinib
1175003|NCT00372567|B2|Baseline|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
1175004|NCT00372567|B1|Baseline|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
1175015|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
1175016|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
1175017|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
1175018|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
1175019|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
1175020|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
1175021|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
1175022|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
1175023|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
1175029|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
1175030|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
1175031|NCT00372567|O1|Outcome|Sunitinib|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
1175032|NCT00372567|E2|Reported Event|Imatinib|All participants who received Imatinib
1175033|NCT00372567|E1|Reported Event|All Participants Who Received Sunitinib|Participants in Phase 1 sub- study and Phase 3 study
1175034|NCT00372528|B1|Baseline|Pregabalin|Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator’s discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
1175035|NCT00372528|P1|Participant Flow|Pregabalin|Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator’s discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
1175036|NCT00372528|O1|Outcome|Pregabalin|Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator’s discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
1175037|NCT00372528|O1|Outcome|Pregabalin|Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator’s discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
1175038|NCT00372528|E1|Reported Event|Pregabalin|Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator’s discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
1175039|NCT00372489|B1|Baseline|Peginesatide|Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.
1175040|NCT00372489|P1|Participant Flow|Peginesatide|Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.
1175041|NCT00372489|O1|Outcome|Peginesatide|Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.
1175042|NCT00372489|E1|Reported Event|Peginesatide|Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.
1175155|NCT00371839|O1|Outcome|Mild HL|"Average hearing loss between 20 and 39 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
1175662|NCT00371176|B3|Baseline|Total|Total of all reporting groups
1175043|NCT00372424|B1|Baseline|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
1175044|NCT00372424|P1|Participant Flow|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
1175045|NCT00372424|O1|Outcome|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
1175059|NCT00372411|P2|Participant Flow|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
1175315|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, ± 2 days.
1175046|NCT00372424|O1|Outcome|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
1175047|NCT00372424|O1|Outcome|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
1175048|NCT00372424|O1|Outcome|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
1175049|NCT00372424|O1|Outcome|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
1175050|NCT00372424|O1|Outcome|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
1175051|NCT00372424|O1|Outcome|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
1175052|NCT00372424|O1|Outcome|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
1183689|NCT00349908|O1|Outcome|Group 1|Atherosclerosis
1175053|NCT00372424|E1|Reported Event|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
1175054|NCT00372411|B4|Baseline|Total|Total of all reporting groups
1175055|NCT00372411|B3|Baseline|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
1175056|NCT00372411|B2|Baseline|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
1175057|NCT00372411|B1|Baseline|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
1175058|NCT00372411|P3|Participant Flow|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
1175130|NCT00371865|B2|Baseline|Acceptance-Based Therapy|"8 group-administered sessions of Acceptance-based therapy~Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
1175060|NCT00372411|P1|Participant Flow|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
1175061|NCT00372411|O3|Outcome|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
1175062|NCT00372411|O2|Outcome|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
1175063|NCT00372411|O1|Outcome|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
1175064|NCT00372411|O3|Outcome|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
1175065|NCT00372411|O2|Outcome|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
1175066|NCT00372411|O1|Outcome|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
1175067|NCT00372411|O3|Outcome|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
1175068|NCT00372411|O2|Outcome|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
1175069|NCT00372411|O1|Outcome|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
1175070|NCT00372411|O3|Outcome|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
1175071|NCT00372411|O2|Outcome|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
1175072|NCT00372411|O1|Outcome|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
1175073|NCT00372411|O3|Outcome|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
1175074|NCT00372411|O2|Outcome|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
1175075|NCT00372411|O1|Outcome|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
1175663|NCT00371176|B2|Baseline|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
1175077|NCT00372411|E2|Reported Event|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
1175078|NCT00372411|E1|Reported Event|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
1175079|NCT00372385|B5|Baseline|Total|Total of all reporting groups
1175080|NCT00372385|B4|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
1175081|NCT00372385|B3|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
1175082|NCT00372385|B2|Baseline|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
1175131|NCT00371865|B1|Baseline|Cognitive Behavioral Therapy|"8 group-administered sessions of Cognitive-Behavioral Therapy~Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
1182466|NCT00352534|O1|Outcome|Very Low Risk|Very Low Risk
1175083|NCT00372385|B1|Baseline|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
1175084|NCT00372385|P4|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
1175085|NCT00372385|P3|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
1175086|NCT00372385|P2|Participant Flow|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
1175087|NCT00372385|P1|Participant Flow|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
1175088|NCT00372385|O1|Outcome|Telaprevir|All Subjects from “Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week”, “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week” and “Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week” reporting groups who received single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks.
1175089|NCT00372385|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
1175090|NCT00372385|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
1175091|NCT00372385|O2|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
1175092|NCT00372385|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
1175093|NCT00372385|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
1175094|NCT00372385|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
1175095|NCT00372385|O2|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
1175156|NCT00371839|E1|Reported Event|Arm 1|"Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
1175157|NCT00371826|B4|Baseline|Total|Total of all reporting groups
1175096|NCT00372385|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
1175097|NCT00372385|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
1175098|NCT00372385|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
1175099|NCT00372385|O2|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
1175132|NCT00371865|P2|Participant Flow|Acceptance-Based Therapy|"8 group-administered sessions of Acceptance-based therapy~Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
1175680|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
1175100|NCT00372385|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
1175101|NCT00372385|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
1175102|NCT00372385|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
1175103|NCT00372385|O2|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
1175104|NCT00372385|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
1175105|NCT00372385|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
1175106|NCT00372385|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
1175107|NCT00372385|O2|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
1175108|NCT00372385|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
1175109|NCT00372385|E4|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
1175110|NCT00372385|E3|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
1175111|NCT00372385|E2|Reported Event|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
1175112|NCT00372385|E1|Reported Event|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
1175113|NCT00372060|B3|Baseline|Total|Total of all reporting groups
1175287|NCT00371787|P2|Participant Flow|Control Group|normal non-lens wearers
1175288|NCT00371787|P1|Participant Flow|Treatment Group|soft lens wearers with sign of hypoxia and high prescription
1175289|NCT00371787|O2|Outcome|Control Group|normal non-lens wearers
1175290|NCT00371787|O1|Outcome|Treatment Group|soft lens wearers with sign of hypoxia and high prescription
1175114|NCT00372060|B2|Baseline|Placebo / Sitagliptin|The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
1175115|NCT00372060|B1|Baseline|Sitagliptin / Sitagliptin|The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin (Weeks 0-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
1175133|NCT00371865|P1|Participant Flow|Cognitive Behavioral Therapy|"8 group-administered sessions of Cognitive-Behavioral Therapy~Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
1175116|NCT00372060|P2|Participant Flow|Placebo / Sitagliptin|The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
1175117|NCT00372060|P1|Participant Flow|Sitagliptin / Sitagliptin|The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin (Weeks 0-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
1175118|NCT00372060|O2|Outcome|Placebo / Sitagliptin|The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) orally once daily and who received at least one dose of sitagliptin and were in the CP. This column of data reflects the change from Week 12 at Week 52.
1175119|NCT00372060|O1|Outcome|Sitagliptin / Sitagliptin|The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin (Weeks 0-52) orally once daily who were in the CP. This column of data reflects the change from Week 0 at Week 52.
1175120|NCT00372060|O2|Outcome|Placebo / Sitagliptin|The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
1175121|NCT00372060|O1|Outcome|Sitagliptin / Sitagliptin|The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin (Weeks 0-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
1175122|NCT00372060|O2|Outcome|Placebo / Sitagliptin|The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
1175123|NCT00372060|O1|Outcome|Sitagliptin / Sitagliptin|The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin (Weeks 0-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
1175124|NCT00372060|O2|Outcome|Placebo / Sitagliptin|The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
1175125|NCT00372060|O1|Outcome|Sitagliptin / Sitagliptin|The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin (Weeks 0-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
1175291|NCT00371787|O2|Outcome|Control Group|normal non-lens wearers
1175292|NCT00371787|O1|Outcome|Treatment Group|soft lens wearers with sign of hypoxia and high prescription
1175293|NCT00371787|O2|Outcome|Control Group|normal non-lens wearers
1175294|NCT00371787|O1|Outcome|Treatment Group|soft lens wearers with sign of hypoxia and high prescription
1175126|NCT00372060|E3|Reported Event|Pooled Sitagliptin (Data Through Week 52)|The Pooled Sitagliptin group includes data from all patients who took sitagliptin in either treatment group. Includes data from Week 0 to Week 52 for patients in the Sitagliptin/Sitagliptin group and data from Week 12 to Week 52 for patients in the Placebo/Sitagliptin group. Includes patients (from either group) who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily.
1175127|NCT00372060|E2|Reported Event|Placebo/Sitagliptin (Data Through Week 12)|The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) orally once daily. This column of data includes only Weeks 0-12.
1175128|NCT00372060|E1|Reported Event|Sitagliptin/Sitagliptin (Data Through Week 12)|The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin orally once daily (Weeks 0-52). This column of data includes only Weeks 0-12.
1175129|NCT00371865|B3|Baseline|Total|Total of all reporting groups
1183409|NCT00350402|B3|Baseline|Total|Total of all reporting groups
1175134|NCT00371865|O2|Outcome|Arm 2|"8 group-administered sessions of Acceptance-based therapy~Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
1175135|NCT00371865|O1|Outcome|Arm 1|"8 group-administered sessions of Cognitive-Behavioral Therapy~Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
1175136|NCT00371865|O2|Outcome|Arm 2|"8 group-administered sessions of Acceptance-based therapy~Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
1175137|NCT00371865|O1|Outcome|Arm 1|"8 group-administered sessions of Cognitive-Behavioral Therapy~Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
1175138|NCT00371865|O2|Outcome|Arm 2|"8 group-administered sessions of Acceptance-based therapy~Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
1175139|NCT00371865|O1|Outcome|Arm 1|"8 group-administered sessions of Cognitive-Behavioral Therapy~Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
1175140|NCT00371865|O2|Outcome|Arm 2|"8 group-administered sessions of Acceptance-based therapy~Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
1175141|NCT00371865|O1|Outcome|Arm 1|"8 group-administered sessions of Cognitive-Behavioral Therapy~Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
1175142|NCT00371865|O2|Outcome|Arm 2|"8 group-administered sessions of Acceptance-based therapy~Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
1175143|NCT00371865|O1|Outcome|Arm 1|"8 group-administered sessions of Cognitive-Behavioral Therapy~Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
1175144|NCT00371865|E2|Reported Event|Arm 2|"8 group-administered sessions of Acceptance-based therapy~Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
1175145|NCT00371865|E1|Reported Event|Arm 1|"8 group-administered sessions of Cognitive-Behavioral Therapy~Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
1175146|NCT00371839|B4|Baseline|Total|Total of all reporting groups
1175147|NCT00371839|B3|Baseline|ModSev HL|"Average hearing loss greater than 50 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
1175148|NCT00371839|B2|Baseline|Mod HL|"Average hearing loss between 40 and 49 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
1175149|NCT00371839|B1|Baseline|Mild HL|"Average hearing loss between 20 and 39 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
1175150|NCT00371839|P3|Participant Flow|ModSev HL|"Average hearing loss greater than 50 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
1175151|NCT00371839|P2|Participant Flow|Mod HL|"Average hearing loss between 40 and 49 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
1175152|NCT00371839|P1|Participant Flow|Mild HL|"Average hearing loss between 20 and 39 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
1175153|NCT00371839|O3|Outcome|ModSev HL|"Average hearing loss greater than 50 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
1175154|NCT00371839|O2|Outcome|Mod HL|"Average hearing loss between 40 and 49 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
1175158|NCT00371826|B3|Baseline|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175159|NCT00371826|B2|Baseline|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175160|NCT00371826|B1|Baseline|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175161|NCT00371826|P3|Participant Flow|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175162|NCT00371826|P2|Participant Flow|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175163|NCT00371826|P1|Participant Flow|Calcineurin Inhibitor (CNI) Withdrawal|Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day
1175164|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175165|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175166|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175295|NCT00371787|O2|Outcome|Control Group|normal non-lens wearers
1175296|NCT00371787|O1|Outcome|Treatment Group|soft lens wearers with sign of hypoxia and high prescription
1175297|NCT00371787|E2|Reported Event|Control Group|normal non-lens wearers
1175167|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175168|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175169|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175170|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175171|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175172|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175173|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175174|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175175|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175298|NCT00371787|E1|Reported Event|Treatment Group|soft lens wearers with sign of hypoxia and high prescription
1175299|NCT00371761|B3|Baseline|Total|Total of all reporting groups
1175300|NCT00371761|B2|Baseline|Adefovir|Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase
1175176|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175177|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175178|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175179|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175180|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175181|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175182|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175183|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175184|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175301|NCT00371761|B1|Baseline|PegIntron|PegIntron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase
1175302|NCT00371761|P2|Participant Flow|Adefovir|Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase
1183690|NCT00349908|O2|Outcome|Group 2|Aneurysm Arm
1175185|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175186|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175187|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175188|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175189|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175190|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175191|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175192|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175193|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175303|NCT00371761|P1|Participant Flow|PegIntron|PegIntron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase
1175304|NCT00371761|O2|Outcome|Adefovir|Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase
1183691|NCT00349908|O1|Outcome|Group 1|Atherosclerosis
1175194|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175195|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175196|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175197|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175198|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175199|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175200|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175201|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175202|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175305|NCT00371761|O1|Outcome|PegIntron|PegIntron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase
1175306|NCT00371761|E2|Reported Event|Adefovir|
1175307|NCT00371761|E1|Reported Event|PegIntron|
1175308|NCT00371683|B3|Baseline|Total|Total of all reporting groups
1175203|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175204|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175205|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175206|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175207|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175208|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175209|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175210|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175211|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175344|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID) plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
1175345|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days,± 2 days.
1175212|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175213|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175214|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175215|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175216|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175217|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175218|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175219|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175220|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175346|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
1175347|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
1175221|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175222|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175223|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175224|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175225|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175226|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175227|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175228|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175229|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175348|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
1175349|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
1175230|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175231|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175232|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175233|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175234|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175235|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175236|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175237|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175238|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175350|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
1175351|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ±2 days.
1175239|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175240|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175241|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175242|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175243|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175244|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175245|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175246|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175247|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175352|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
1175353|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
1175248|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175249|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175250|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175251|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175252|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175253|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175254|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175255|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175256|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175354|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
1175355|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ±2 days.
1175257|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175258|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175259|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175260|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175261|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175262|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175263|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175264|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175265|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175356|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
1175357|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus placebo tablets BID for 12 days, ± 2 days.
1175266|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175267|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175268|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175269|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175270|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175271|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175272|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175273|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175274|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175358|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
1175359|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, ± 2 days.
1175275|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175276|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175277|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175278|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175279|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175280|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175281|NCT00371826|E3|Reported Event|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
1175282|NCT00371826|E2|Reported Event|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
1175283|NCT00371826|E1|Reported Event|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
1175284|NCT00371787|B3|Baseline|Total|Total of all reporting groups
1175285|NCT00371787|B2|Baseline|Control Group|normal non-lens wearers
1175286|NCT00371787|B1|Baseline|Treatment Group|soft lens wearers with sign of hypoxia and high prescription
1175309|NCT00371683|B2|Baseline|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg subcutaneous (SC) injection every (q) 12 hours (h) plus matching placebo tablets BID for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug; and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72).
1175310|NCT00371683|B1|Baseline|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets twice a day (BID) plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug; and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72).
1175311|NCT00371683|P2|Participant Flow|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg subcutaneous (SC) injection every (q) 12 hours (h) plus matching placebo tablets BID for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug(day of surgery or next day); and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72).
1175312|NCT00371683|P1|Participant Flow|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets twice a day (BID) plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug (day of surgery or next day); and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72).
1175313|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, ±2 days.
1175681|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
1175316|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days,± 2 days.
1175317|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
1175318|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID) plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
1175319|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, ± 2 days.
1175320|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days,± 2 days.
1175321|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, ± 2 days.
1175322|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days.
1175323|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, plus or minus 2 days.
1175324|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days.
1175325|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, plus or minus 2 days.
1175326|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days.
1175327|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, ± 2 days.
1175328|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days.
1175329|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
1175330|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
1175331|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, ±2 days.
1175332|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
1175333|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
1175334|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
1175335|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
1175336|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
1175337|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
1175338|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
1175339|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
1175340|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
1175341|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
1175342|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
1175343|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
1175361|NCT00371683|E2|Reported Event|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg subcutaneous (SC) injection every (q) 12 hours (h) plus matching placebo tablets BID for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug; and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72).
1175362|NCT00371683|E1|Reported Event|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets twice a day (BID) plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug; and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72).
1175363|NCT00371644|B3|Baseline|Total|Total of all reporting groups
1175364|NCT00371644|B2|Baseline|Arm 2|"Participants receive 12 biweekly sessions of Present Centered Therapy (PCT).~Present-Centered Therapy: PCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD."
1175365|NCT00371644|B1|Baseline|Arm 1|"Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT).~Cognitive Processing Therapy: CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape."
1175384|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175366|NCT00371644|P2|Participant Flow|Present Centered Therapy (PCT)|"Participants receive 12 biweekly sessions of Present Centered Therapy (PCT).~Present-Centered Therapy: PCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD."
1175367|NCT00371644|P1|Participant Flow|Cognitive Processing Therapy (CPT)|"Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT).~Cognitive Processing Therapy: CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape."
1175368|NCT00371644|O2|Outcome|Present Centered Therapy (PCT)|"Participants receive 12 biweekly sessions of Present Centered Therapy (PCT).~Present-Centered Therapy: PCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD."
1175369|NCT00371644|O1|Outcome|Cognitive Processing Therapy (CPT)|"Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT).~Cognitive Processing Therapy: CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape."
1175370|NCT00371644|E2|Reported Event|Arm 2|"Participants receive 12 biweekly sessions of Present Centered Therapy (PCT).~Present-Centered Therapy: PCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD."
1175371|NCT00371644|E1|Reported Event|Arm 1|"Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT).~Cognitive Processing Therapy: CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape."
1175372|NCT00371631|B1|Baseline|Treatment Arm|"insertion of E. coli coated catheter~Insertion of urinary catheters coated with E. coli 83972: All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli."
1175373|NCT00371631|P1|Participant Flow|Treatment Arm|"insertion of E. coli coated catheter~Insertion of urinary catheters coated with E. coli 83972: All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli."
1175374|NCT00371631|O1|Outcome|Treatment Arm|"insertion of E. coli coated catheter~Insertion of urinary catheters coated with E. coli 83972: All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli."
1175375|NCT00371631|O1|Outcome|Treatment Arm|"insertion of E. coli coated catheter~Insertion of urinary catheters coated with E. coli 83972: All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli."
1175376|NCT00371631|E1|Reported Event|Treatment Arm|"insertion of E. coli coated catheter~Insertion of urinary catheters coated with E. coli 83972: All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli."
1175377|NCT00371566|B3|Baseline|Total|Total of all reporting groups
1175378|NCT00371566|B2|Baseline|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175379|NCT00371566|B1|Baseline|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175380|NCT00371566|P2|Participant Flow|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175381|NCT00371566|P1|Participant Flow|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the institutions standard of care)
1175382|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175383|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175512|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
1186553|NCT00335556|E1|Reported Event|Surgery|Surgery Only
1175385|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175386|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175387|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175388|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175389|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175390|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175391|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175392|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175393|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175394|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175395|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175396|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175397|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175398|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175399|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175400|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175401|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175664|NCT00371176|B1|Baseline|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
1175402|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175403|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175404|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175405|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175406|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175407|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175408|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175409|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175682|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
1175410|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175411|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175412|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175413|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175414|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175415|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175416|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175417|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175418|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175419|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175420|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175421|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175422|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175423|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175424|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175425|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175426|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175719|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
1175427|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175428|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175429|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175430|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175431|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175432|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175433|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175434|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175435|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175436|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175437|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175438|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175439|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175440|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175441|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175442|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175443|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175444|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175445|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175446|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175447|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175448|NCT00371566|E2|Reported Event|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of mor than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
1175449|NCT00371566|E1|Reported Event|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
1175450|NCT00371540|B3|Baseline|Total|Total of all reporting groups
1175451|NCT00371540|B2|Baseline|II Home Visits|"Follow-up in clinic every 3 months, home visits monthly~Home visit by community care coordinators: Decrease in patient visits to the clinic from the standard of once per month to every 3 months with home visits monthly."
1175452|NCT00371540|B1|Baseline|I Routine Care|Routine care in the clinic
1175453|NCT00371540|P2|Participant Flow|II Home Visits|"Follow-up in clinic every 3 months, home visits monthly~Home visit by community care coordinators: Decrease in patient visits to the clinic from the standard of once per month to every 3 months with home visits monthly."
1183692|NCT00349908|O2|Outcome|Group 2|Aneurysm Arm
1175464|NCT00371462|B2|Baseline|Arm 2|"MOVE! level 2 + Personal Digital Assistant decision support tool (PDA) (Treatment)~MOVE! level 2 group weight loss counseling: Participants will attend the MOVE! group and will be asked to complete assessments at 3, 6, 9, and 12 months."
1175465|NCT00371462|B1|Baseline|Arm 1|"MOVE! level 2 group weight loss counseling, the VA standard of care alone (Standard Care);~Use of PDA + support to reduce weight and pain: participants will attend the MOVE! group, record their food, activity, mood, pain, and weight daily via a PDA. Participants will be assigned a coach to help them set physical activity and calorie goals in order to produce a weight loss of .5%-1% per week on average over the course of 6 months. Participants will continue to log using the PDA during the 2nd 6-months for follow-up. They will also be asked to attend assessments at 3, 6, 9, and 12 months."
1175466|NCT00371462|P2|Participant Flow|Standard-of-care|Participants were provided standard-of-care (participation in VA MOVE program) for weight loss.
1175467|NCT00371462|P1|Participant Flow|+ Mobile|Participants were provided standard-of-care (participation in VA MOVE program) plus a connective mobile technology system. Participants were provided a personal digital assistant to self-monitor diet and physical activity; they also received biweekly coaching calls for 6 months.
1175468|NCT00371462|O2|Outcome|Standard-of-care|Participants were provided standard-of-care (participation in VA MOVE program) for weight loss.
1175469|NCT00371462|O1|Outcome|+ Mobile|Participants were provided standard-of-care (participation in VA MOVE program) plus a connective mobile technology system. Participants were provided a personal digital assistant to self-monitor diet and physical activity; they also received biweekly coaching calls for 6 months.
1175470|NCT00371462|E2|Reported Event|Standard-of-care|Participants were provided standard-of-care (participation in VA MOVE program) for weight loss.
1175513|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
1175683|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
1175471|NCT00371462|E1|Reported Event|+ Mobile|Participants were provided standard-of-care (participation in VA MOVE program) plus a connective mobile technology system. Participants were provided a personal digital assistant to self-monitor diet and physical activity; they also received biweekly coaching calls for 6 months.
1175472|NCT00371449|B1|Baseline|Hearing Aid Users|Hearing aid users
1175473|NCT00371449|P1|Participant Flow|Hearing-Aid Users|Individuals who wore hearing aids for > 3 months and at their current setting for at least 1 month
1175474|NCT00371449|O1|Outcome|Hearing Aid Users|hearing aid users
1175475|NCT00371449|O1|Outcome|Hearing Aid Users|hearing aid users
1175476|NCT00371449|O1|Outcome|Hearing Aid Users|hearing aid users
1175477|NCT00371449|O1|Outcome|Hearing Aid Users|hearing aid users
1175478|NCT00371449|O1|Outcome|Hearing-aid Users|hearing aid users
1175479|NCT00371449|O1|Outcome|Group 1|hearing aid users
1175480|NCT00371449|E1|Reported Event|Hearing-aid Users|
1175481|NCT00371436|B3|Baseline|Total|Total of all reporting groups
1175482|NCT00371436|B2|Baseline|Usual Care|Usual Care: Typical audiologic care that would be received in a VA Audiology Clinic.
1175483|NCT00371436|B1|Baseline|Tinnitus Progressive Management|"Tinnitus Progressive Management: The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individual management."
1175484|NCT00371436|P2|Participant Flow|Usual Care|Usual Care: Typical audiologic care that would be received in a VA Audiology Clinic.
1175485|NCT00371436|P1|Participant Flow|Tinnitus Progressive Management|"Tinnitus Progressive Management: The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individual management."
1175486|NCT00371436|O2|Outcome|Arm 2|"Usual Care~Usual Care: Typical audiologic care that would be received in a VA Audiology Clinic."
1175487|NCT00371436|O1|Outcome|Arm 1|"Tinnitus Progressive Management~Tinnitus Progressive Management: The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individual management."
1175488|NCT00371436|E2|Reported Event|Usual Care|Usual Care: Typical audiologic care that would be received in a VA Audiology Clinic.
1175489|NCT00371436|E1|Reported Event|Tinnitus Progressive Management|"Tinnitus Progressive Management: The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individual management."
1175490|NCT00371397|B1|Baseline|Overall Study|Women were exposed to each of the conditions (yoga, movement control, and passive-video control) during three separate visits. The order of the visits was randomized per participant. 52 total participants enrolled.
1175491|NCT00371397|P12|Participant Flow|Novice: Video Then Hatha Yoga Then Movement Control|"Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.~For Session 1, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Movement Control Activity in 1 day and a 30 minute follow-up session the next morning."
1175492|NCT00371397|P11|Participant Flow|Novice: Hatha Yoga Then Movement Control Then Video|"Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.~For Session 1, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Movement Control Activity in 1 day and a 30 minute follow-up session the next morning.~For Session 3, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity."
1175493|NCT00371397|P10|Participant Flow|Novice: Movement Control Then Video Then Hatha Yoga|"Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.~For Session 1, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Hatha Yoga session in 1 day and a 30 minute follow-up session the next morning."
1175494|NCT00371397|P9|Participant Flow|Novice: Video Then Movement Control Then Hatha Yoga|"Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.~For Session 1, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Hatha Yoga session in 1 day and a 30 minute follow-up session the next morning."
1175495|NCT00371397|P8|Participant Flow|Novice: Hatha Yoga Then Video Then Movement Control|"Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.~For Session 1, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning."
1175496|NCT00371397|P7|Participant Flow|Novice: Movement Control Then Hatha Yoga Then Video|"Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.~For Session 1, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning."
1175497|NCT00371397|P6|Participant Flow|Expert: Video Then Hatha Yoga Then Movement Control|"Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.~For Session 1, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Movement Control Activity in 1 day and a 30 minute follow-up session the next morning."
1175498|NCT00371397|P5|Participant Flow|Expert: Hatha Yoga Then Movement Control Then Video|"Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.~For Session 1, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning."
1175499|NCT00371397|P4|Participant Flow|Expert: Movement Control Then Video Then Hatha Yoga|"Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.~For Session 1, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Hatha Yoga session in 1 day and a 30 minute follow-up session the next morning."
1175500|NCT00371397|P3|Participant Flow|Expert: Video Then Movement Control Then Hatha Yoga|"Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.~For Session 1, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Hatha Yoga Class in 1 day and a 30 minute follow-up session the next morning."
1175501|NCT00371397|P2|Participant Flow|Expert: Hatha Yoga Then Video Then Movement Control|"Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.~For Session 1, participants completed the Hatha Yoga Class in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning."
1175502|NCT00371397|P1|Participant Flow|Expert: Movement Control Then Hatha Yoga Then Video|"Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.~For Session 1, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Hatha Yoga Class in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning."
1175503|NCT00371397|O2|Outcome|Expert|Women were classified as Experts if they had practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.
1175504|NCT00371397|O1|Outcome|Novice|Women were classified as novices if they had participated in yoga classes or home practice with yoga videos for 6 - 12 sessions.
1175505|NCT00371397|E2|Reported Event|Expert|Women were classified as Experts if they had practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.
1175506|NCT00371397|E1|Reported Event|Novice|Women were classified as novices if they had participated in yoga classes or home practice with yoga videos for 6 - 12 sessions.
1175507|NCT00371345|B3|Baseline|Total|Total of all reporting groups
1175508|NCT00371345|B2|Baseline|ER and/or PgR Positive Tumor Type|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
1175509|NCT00371345|B1|Baseline|Her2/Neu-amplified Tumor Type|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
1175510|NCT00371345|P2|Participant Flow|ER and/or PgR Positive Tumor Type|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
1175511|NCT00371345|P1|Participant Flow|Her2/Neu-amplified Tumor Type|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
1175675|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
1175514|NCT00371345|O4|Outcome|ER and/or PgR Positive Tumor, 100 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
1175515|NCT00371345|O3|Outcome|ER and/or PgR Positive Tumor, 70 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
1175516|NCT00371345|O2|Outcome|Her2/Neu-amplified Tumor, 100 mg BID|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
1175517|NCT00371345|O1|Outcome|Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
1175518|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
1175519|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
1175520|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
1175521|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
1175522|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
1175523|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
1175524|NCT00371345|O3|Outcome|Dasatinib 50 mg|Dasatinib was administered orally at a starting dose of 70 mg BID. Dose adjustment was made according to tolerance, with reduction to 50 mg BID. Participants continued study treatment until PD or unacceptable toxicity. Dasatinib dose was adjusted so that drug-related toxicities were either Grade 0 - 1 or were Grade 2 toxicities that were adequately managed with outpatient therapy or deemed clinically acceptable.
1175525|NCT00371345|O2|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
1175526|NCT00371345|O1|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
1175527|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
1175528|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
1175529|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
1175530|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
1175531|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
1175532|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
1175533|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
1175534|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
1175535|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
1175536|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
1175537|NCT00371345|O3|Outcome|Participant CA180088-29-88085, ER and/or PgR Group|Participant with ER and PgR–amplified tumor type who received 70 mg dasatinib BID
1175538|NCT00371345|O2|Outcome|Participant CA180088-16-88002, ER and/or PgR Group|Participant with ER and PgR–amplified tumor type who received 100 mg dasatinib BID
1175539|NCT00371345|O1|Outcome|Participant CA180088-18-88009, HER-2 Group|Participant with Human epidermal growth factor (Her2/neu)–amplified tumor type (also positive for ER and PgR) who received 100 mg dasatinib BID.
1175720|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
1175540|NCT00371345|O4|Outcome|ER and/or PgR Positive Tumor, 100 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
1175541|NCT00371345|O3|Outcome|ER and/or PgR Positive Tumor, 70 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
1175542|NCT00371345|O2|Outcome|Her2/Neu-amplified Tumor, 100 mg BID Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
1175543|NCT00371345|O1|Outcome|Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
1175544|NCT00371345|O2|Outcome|ER and/or PgR Positive Tumor|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally dasatinib twice daily (BID).
1175545|NCT00371345|O1|Outcome|Her2/Neu-amplified Tumor|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally dasatinib twice daily (BID).
1175546|NCT00371345|O3|Outcome|All Participants|Dasatinib was administered orally at 70 mg BID (TDD=140 mg) or 100 mg BID (TDD=200 mg).
1175547|NCT00371345|O2|Outcome|ER and/or PgR Positive Tumor|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally dasatinib twice daily (BID).
1175548|NCT00371345|O1|Outcome|Her2/Neu-amplified Tumor|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally dasatinib twice daily (BID).
1175549|NCT00371345|O4|Outcome|ER and/or PgR Positive Tumor, 100 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
1175550|NCT00371345|O3|Outcome|ER and/or PgR Positive Tumor, 70 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
1175551|NCT00371345|O2|Outcome|Her2/Neu-amplified Tumor, 100 mg BID Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
1175552|NCT00371345|O1|Outcome|Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
1175553|NCT00371345|O4|Outcome|ER and/or PgR Positive Tumor, 100 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
1175554|NCT00371345|O3|Outcome|ER and/or PgR Positive Tumor, 70 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
1175555|NCT00371345|O2|Outcome|Her2/Neu-amplified Tumor, 100 mg BID Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
1175556|NCT00371345|O1|Outcome|Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
1175557|NCT00371345|O5|Outcome|All Response-evaluable Participants|Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment).
1175558|NCT00371345|O4|Outcome|ER and/or PgR Positive Tumor, 100 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
1175559|NCT00371345|O3|Outcome|ER and/or PgR Positive Tumor, 70 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
1175560|NCT00371345|O2|Outcome|Her2/Neu-amplified Tumor, 100 mg BID Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
1183693|NCT00349908|O1|Outcome|Group 1|Atherosclerosis
1175561|NCT00371345|O1|Outcome|Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
1175562|NCT00371345|O4|Outcome|ER and/or PgR Positive Tumor, 100 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
1175563|NCT00371345|O3|Outcome|ER and/or PgR Positive Tumor, 70 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
1175564|NCT00371345|O2|Outcome|Her2/Neu-amplified Tumor, 100 mg BID|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
1175565|NCT00371345|O1|Outcome|Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
1175566|NCT00371345|E1|Reported Event|Dasatinib|Dasatinib was administered orally at 70 mg BID (TDD=140 mg) or 100 mg BID (TDD=200 mg).
1175567|NCT00371293|B4|Baseline|Total|Total of all reporting groups
1186554|NCT00335517|B1|Baseline|Injection|DepoDur Injection
1175568|NCT00371293|B3|Baseline|Combination|"Participants will receive CPAP therapy and take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
1175569|NCT00371293|B2|Baseline|Weight Loss|"Participants will take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity."
1175570|NCT00371293|B1|Baseline|CPAP|"Participants will receive CPAP therapy.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
1175571|NCT00371293|P3|Participant Flow|Combination|"Participants will receive CPAP therapy and take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
1175572|NCT00371293|P2|Participant Flow|Weight Loss|"Participants will take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity."
1175573|NCT00371293|P1|Participant Flow|CPAP|"Participants will receive CPAP therapy.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
1175574|NCT00371293|O3|Outcome|Combination - Adherent|"Participants will receive CPAP therapy and take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
1175575|NCT00371293|O2|Outcome|Weight Loss - Adherent|"Participants will take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity."
1175576|NCT00371293|O1|Outcome|CPAP - Adherent|"Participants will receive CPAP therapy.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
1175577|NCT00371293|O3|Outcome|Combination - Adherent|"Participants will receive CPAP therapy and take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
1175578|NCT00371293|O2|Outcome|Weight Loss - Adherent|"Participants will take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity."
1175579|NCT00371293|O1|Outcome|CPAP - Adherent|"Participants will receive CPAP therapy.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
1175580|NCT00371293|O3|Outcome|Combination - Adherent|"Participants will receive CPAP therapy and take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
1175581|NCT00371293|O2|Outcome|Weight Loss - Adherent|"Participants will take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity."
1175582|NCT00371293|O1|Outcome|CPAP - Adherent|"Participants will receive CPAP therapy.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
1175583|NCT00371293|O3|Outcome|Combination - Adherent|"Participants will receive CPAP therapy and take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
1175584|NCT00371293|O2|Outcome|Weight Loss - Adherent|"Participants will receive take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity."
1175586|NCT00371293|O3|Outcome|Combination - Adherent|"Participants will receive CPAP therapy and take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
1175587|NCT00371293|O2|Outcome|Weight Loss - Adherent|"Participants will take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity."
1175588|NCT00371293|O1|Outcome|CPAP - Adherent|"Participants will receive CPAP therapy.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
1175589|NCT00371293|E3|Reported Event|Weight Loss|"Participants will take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity."
1175590|NCT00371293|E2|Reported Event|Combination|"Participants will receive CPAP therapy and take part in a weight loss program.~Weight Loss Program: Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
1175591|NCT00371293|E1|Reported Event|CPAP|"Participants will receive CPAP therapy.~CPAP therapy: Participants receiving CPAP therapy will use a CPAP machine each night while they sleep."
1175592|NCT00371267|B3|Baseline|Total|Total of all reporting groups
1175593|NCT00371267|B2|Baseline|Arm 2|"Telephone-delivered patient education regarding management of chronic pain~Pain Education: Telephone-delivered education regarding chronic pain"
1175676|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
1175594|NCT00371267|B1|Baseline|Arm 1|"Telephone-delivered cognitive behavior therapy for pain management~Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
1175595|NCT00371267|P2|Participant Flow|Arm 2|"Telephone-delivered patient education regarding management of chronic pain~Pain Education: Telephone-delivered education regarding chronic pain"
1175596|NCT00371267|P1|Participant Flow|Arm 1|"Telephone-delivered cognitive behavior therapy for pain management~Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
1175597|NCT00371267|O2|Outcome|Arm 2: Telephone Patient Education|"Telephone-delivered patient education regarding management of chronic pain~Pain Education: Telephone-delivered education regarding chronic pain"
1175598|NCT00371267|O1|Outcome|Arm 1: Telephone CBT|"Telephone-delivered cognitive behavior therapy for pain management~Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
1175599|NCT00371267|O2|Outcome|Arm 2: Telephone Patient Education|"Telephone-delivered patient education regarding management of chronic pain~Pain Education: Telephone-delivered education regarding chronic pain"
1175600|NCT00371267|O1|Outcome|Arm 1: Telephone CBT|"Telephone-delivered cognitive behavior therapy for pain management~Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
1175601|NCT00371267|O2|Outcome|Arm 2: Telephone Patient Education|"Telephone-delivered patient education regarding management of chronic pain~Pain Education: Telephone-delivered education regarding chronic pain"
1175602|NCT00371267|O1|Outcome|Arm 1: Telephone CBT|"Telephone-delivered cognitive behavior therapy for pain management~Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
1175603|NCT00371267|O2|Outcome|Arm 2: Telephone Patient Education|"Telephone-delivered patient education regarding management of chronic pain~Pain Education: Telephone-delivered education regarding chronic pain"
1175604|NCT00371267|O1|Outcome|Arm 1: Telephone CBT|"Telephone-delivered cognitive behavior therapy for pain management~Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
1175605|NCT00371267|O2|Outcome|Arm 2: Telephone Patient Education|"Telephone-delivered patient education regarding management of chronic pain~Pain Education: Telephone-delivered education regarding chronic pain"
1175606|NCT00371267|O1|Outcome|Arm 1: Telephone CBT|"Telephone-delivered cognitive behavior therapy for pain management~Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
1175607|NCT00371267|E2|Reported Event|Arm 2|"Telephone-delivered patient education regarding management of chronic pain~Pain Education: Telephone-delivered education regarding chronic pain"
1175608|NCT00371267|E1|Reported Event|Arm 1|"Telephone-delivered cognitive behavior therapy for pain management~Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
1175609|NCT00371254|B3|Baseline|Total|Total of all reporting groups
1175610|NCT00371254|B2|Baseline|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175611|NCT00371254|B1|Baseline|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175612|NCT00371254|P2|Participant Flow|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175613|NCT00371254|P1|Participant Flow|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1176860|NCT00368069|O1|Outcome|Keppra®|Keppra® extended release formulation (XR)
1175614|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175615|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175616|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175617|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175677|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
1175678|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
1175618|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175619|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175620|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175621|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175622|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175623|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175624|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175625|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175626|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175627|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175628|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175629|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175630|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175631|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175632|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175633|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175634|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175635|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175636|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175637|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175638|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175639|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175640|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175641|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175642|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175643|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175644|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175645|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175646|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175647|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175648|NCT00371254|O3|Outcome|Dasatinib 50 mg BID|Participants were administered an oral dose of 50 mg dasatinib tablet twice daily for a total daily dose (TDD) of 100 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175649|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175650|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175651|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175652|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175653|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175654|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175655|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175656|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175657|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175658|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175659|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175660|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175661|NCT00371254|E1|Reported Event|All Participants|All treated participants who were administered a twice-daily oral dose of either 100 mg (TDD 200 mg) or 70 mg (TDD 140 mg) dasatinib tablet. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
1175665|NCT00371176|P2|Participant Flow|Placebo Plus Exposure|Treatment entailed six 60-90 minute sessions. Session 1 focused on psychoeducation and building of rapport, sessions 2-5 of brief imaginal exposure therapy plus a placebo pill 30 minutes prior to each session, and session 6 consisted of a review of treatment gains, discussion of relapse-prevention strategies, and termination.
1175666|NCT00371176|P1|Participant Flow|D-Cycloserine Plus Exposure|Treatment entailed six 60-90 minute sessions. Session 1 focused on psychoeducation and building of rapport, sessions 2-5 of brief imaginal exposure therapy plus a 50 mg DCS pill 30 minutes prior to each session, and session 6 consisted of a review of treatment gains, discussion of relapse-prevention strategies, and termination.
1175667|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
1175668|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
1175669|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
1175670|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
1175671|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
1175672|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
1175673|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
1175674|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
1186555|NCT00335517|P1|Participant Flow|Injection|DepoDur Injection
1175684|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
1175685|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
1175686|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
1175687|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
1175688|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
1175689|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
1175690|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
1175691|NCT00371176|E2|Reported Event|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
1175692|NCT00371176|E1|Reported Event|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
1175693|NCT00371150|B3|Baseline|Total|Total of all reporting groups
1175694|NCT00371150|B2|Baseline|Hispanic|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
1175695|NCT00371150|B1|Baseline|Black/ African American|Entecavir (ETV) tablets, Oral, 0.5 mg, once daily, up to 52 weeks
1175696|NCT00371150|P2|Participant Flow|Hispanic|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
1175697|NCT00371150|P1|Participant Flow|Black/ African American|Entecavir (ETV) tablets, Oral, 0.5 mg, once daily, up to 52 weeks
1175698|NCT00371150|O2|Outcome|Total|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
1175699|NCT00371150|O1|Outcome|Black / African American|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
1175700|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
1175701|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
1175702|NCT00371150|O2|Outcome|Total|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
1175703|NCT00371150|O1|Outcome|Black / African American|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
1175704|NCT00371150|O3|Outcome|Total|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
1175705|NCT00371150|O2|Outcome|Hispanic|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
1175706|NCT00371150|O1|Outcome|Black / African American|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
1175707|NCT00371150|O2|Outcome|Total|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
1175708|NCT00371150|O1|Outcome|Black / African American|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
1175709|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
1175710|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
1175711|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
1175712|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
1175713|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
1175714|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
1175715|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
1175716|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
1175717|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
1175718|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
1176861|NCT00368069|O2|Outcome|Placebo|placebo
1175721|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
1175722|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
1175723|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
1175724|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
1175725|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
1175726|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
1175727|NCT00371150|E1|Reported Event|Entecavir (ETV)|Entecavir tablets, Oral, 0.5 mg, once daily, up to 48 weeks (Includes 6 participants of the Hispanic cohort)
1175728|NCT00371137|B4|Baseline|Total|Total of all reporting groups
1175729|NCT00371137|B3|Baseline|Xyrem 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
1175730|NCT00371137|B2|Baseline|Xyrem 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
1175731|NCT00371137|B1|Baseline|Placebo|Placebo taken as two equally divided nightly doses
1175732|NCT00371137|P3|Participant Flow|Xyrem 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
1175733|NCT00371137|P2|Participant Flow|Xyrem 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
1175734|NCT00371137|P1|Participant Flow|Placebo|Placebo taken as two equally divided nightly doses
1175735|NCT00371137|O3|Outcome|Xyrem 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
1175736|NCT00371137|O2|Outcome|Xyrem 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
1175737|NCT00371137|O1|Outcome|Placebo|Placebo taken as two equally divided nightly doses
1175738|NCT00371137|E3|Reported Event|Xyrem 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
1175739|NCT00371137|E2|Reported Event|Xyrem 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
1175740|NCT00371137|E1|Reported Event|Placebo|Placebo taken as two equally divided nightly doses
1175741|NCT00370994|B3|Baseline|Total|Total of all reporting groups
1175742|NCT00370994|B2|Baseline|Pecutaneous Adhesiolysis|Pecutaneous adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
1175743|NCT00370994|B1|Baseline|Caudal Epidural Injection|Caudal epidural with placement of catheter in sacral canal with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 0.9% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
1175744|NCT00370994|P2|Participant Flow|Pecutaneous Adhesiolysis|Pecutaneous adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
1175745|NCT00370994|P1|Participant Flow|Caudal Epidural Injection|Caudal epidural with placement of catheter in sacral canal with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 0.9% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution.
1175746|NCT00370994|O2|Outcome|Intervention Group|adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
1175747|NCT00370994|O1|Outcome|Control Group|caudal epidural injections since no adhesiolysis was performed and there was no injection of 10% sodium chloride solution.
1175748|NCT00370994|O2|Outcome|Intervention Group|adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
1175749|NCT00370994|O1|Outcome|Control Group|caudal epidural injections since no adhesiolysis was performed and there was no injection of 10% sodium chloride solution.
1175750|NCT00370994|E2|Reported Event|Pecutaneous Adhesiolysis|Pecutaneous adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
1175751|NCT00370994|E1|Reported Event|Caudal Epidural Injection|Caudal epidural with placement of catheter in sacral canal with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 0.9% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
1175752|NCT00370838|B3|Baseline|Total|Total of all reporting groups
1175753|NCT00370838|B2|Baseline|Clonidine First, Then Levetiracetam|"Participants first received clonidine, packaged in look-alike capsules: starting dose was 0.05 milligram (mg) twice a day, if needed, the dose increased weekly by 0.05-0.1 mg. The maximum dose was 0.4 mg (0.2 mg twice a day (BID)).~In the second period, participants received levetiracetam: starting dose of 10 mg/killigram(kg)/day, increased weekly by 5-10 mg/kg/day, to a maximum of 50 mg/kg/day (25 mg/kg BID; 2,500 mg per day).~Wash out phase: Between the two treatment phases, medication tapered over a ten day period: levetiracetam by 5-10 mg/kg/day every third day; clonidine by 0.05 - 0.1 mg every third day. Subjects were off medication for 5 days before starting the second phase of the cross over study.~Taper: After the two treatment phases, medication tapered over a ten day period as in Wash-out phase (see above)."
1175754|NCT00370838|B1|Baseline|Levetiracetam First, Then Clonidine|"Participants first received levetiracetam: starting dose of 10 milligram/killigram/day, increased weekly by 5-10 milligram/killigram/day, to a maximum of 50 milligram/killigram/day (25 milligram/killigram twice a day; 2,500 mg per day).~In the second period, participants received clonidine (days 65-107), packaged in look-alike capsules: starting dose was 0.05 milligrams twice a day, if needed, the dose increased weekly by 0.05-0.1 milligrams. The maximum dose was 0.4 milligrams (0.2 milligrams twice a day).~Wash out phase: Between the two treatment phases, medication tapered over a ten day period: levetiracetam by 5-10 mg/kg/day every third day; clonidine by 0.05 - 0.1 mg every third day. Subjects were off medication for 5 days before starting the second phase of the cross over study.~Taper: After the two treatment phases, medication tapered over a ten day period as in Wash-out phase (see above)."
1175923|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
1175755|NCT00370838|P2|Participant Flow|Clonidine First, Then Levetiracetam|"Participants first received clonidine, packaged in look-alike capsules: starting dose was 0.05 milligram (mg) twice a day, if needed, the dose increased weekly by 0.05-0.1 mg. The maximum dose was 0.4 mg (0.2 mg twice a day (BID)).~In the second period, participants received levetiracetam: starting dose of 10 mg/killigram(kg)/day, increased weekly by 5-10 mg/kg/day, to a maximum of 50 mg/kg/day (25 mg/kg BID; 2,500 mg per day).~Wash out phase: Between the two treatment phases, medication tapered over a ten day period: levetiracetam by 5-10 mg/kg/day every third day; clonidine by 0.05 - 0.1 mg every third day. Subjects were off medication for 5 days before starting the second phase of the cross over study.~Taper: After the two treatment phases, medication tapered over a ten day period as in Wash-out phase (see above)."
1175756|NCT00370838|P1|Participant Flow|First Levetiracetam Then Clonidine|"Participants first received levetiracetam: starting dose of 10 milligram/killigram/day, increased weekly by 5-10 milligram/killigram/day, to a maximum of 50 milligram/killigram/day (25 milligram/killigram twice a day; 2,500 mg per day).~In the second period, participants received clonidine (days 65-107), packaged in look-alike capsules: starting dose was 0.05 milligrams twice a day, if needed, the dose increased weekly by 0.05-0.1 milligrams. The maximum dose was 0.4 milligrams (0.2 milligrams twice a day).~Wash out phase: Between the two treatment phases, medication tapered over a ten day period: levetiracetam by 5-10 mg/kg/day every third day; clonidine by 0.05 - 0.1 mg every third day. Subjects were off medication for 5 days before starting the second phase of the cross over study.~Taper: After the two treatment phases, medication tapered over a ten day period as in Wash-out phase (see above)."
1175757|NCT00370838|O2|Outcome|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
1175758|NCT00370838|O1|Outcome|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
1186556|NCT00335517|O1|Outcome|Injection|DepoDur Injection
1175759|NCT00370838|O2|Outcome|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
1175760|NCT00370838|O1|Outcome|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
1175761|NCT00370838|O2|Outcome|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
1175762|NCT00370838|O1|Outcome|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
1175763|NCT00370838|O2|Outcome|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
1175764|NCT00370838|O1|Outcome|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
1175765|NCT00370838|O2|Outcome|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
1175766|NCT00370838|O1|Outcome|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
1175767|NCT00370838|O2|Outcome|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
1175768|NCT00370838|O1|Outcome|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
1175769|NCT00370838|O2|Outcome|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
1175770|NCT00370838|O1|Outcome|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
1175771|NCT00370838|E2|Reported Event|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
1175772|NCT00370838|E1|Reported Event|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
1175773|NCT00370682|B4|Baseline|Total|Total of all reporting groups
1186557|NCT00335517|E1|Reported Event|Injection|DepoDur Injection
1175774|NCT00370682|B3|Baseline|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection~Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175775|NCT00370682|B2|Baseline|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months~T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175776|NCT00370682|B1|Baseline|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months~T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175777|NCT00370682|P3|Participant Flow|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection~Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175778|NCT00370682|P2|Participant Flow|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months~T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175779|NCT00370682|P1|Participant Flow|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months~T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175780|NCT00370682|O3|Outcome|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection~Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175781|NCT00370682|O2|Outcome|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months~T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175782|NCT00370682|O1|Outcome|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months~T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175783|NCT00370682|O3|Outcome|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection~Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175784|NCT00370682|O2|Outcome|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months~T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175785|NCT00370682|O1|Outcome|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months~T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175786|NCT00370682|O3|Outcome|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection~Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175787|NCT00370682|O2|Outcome|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months~T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175788|NCT00370682|O1|Outcome|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months~T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175789|NCT00370682|O3|Outcome|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection~Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175790|NCT00370682|O2|Outcome|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months~T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175791|NCT00370682|O1|Outcome|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months~T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175792|NCT00370682|O3|Outcome|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection~Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175793|NCT00370682|O2|Outcome|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months~T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175794|NCT00370682|O1|Outcome|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months~T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175795|NCT00370682|O3|Outcome|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection~Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175796|NCT00370682|O2|Outcome|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months~T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175797|NCT00370682|O1|Outcome|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months~T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175798|NCT00370682|O3|Outcome|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection~Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1186558|NCT00335504|B5|Baseline|Total|Total of all reporting groups
1175799|NCT00370682|O2|Outcome|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months~T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175800|NCT00370682|O1|Outcome|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months~T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175801|NCT00370682|O3|Outcome|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection~Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175802|NCT00370682|O2|Outcome|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months~T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175803|NCT00370682|O1|Outcome|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months~T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175804|NCT00370682|O3|Outcome|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection~Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175805|NCT00370682|O2|Outcome|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months~T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175806|NCT00370682|O1|Outcome|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months~T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175807|NCT00370682|O4|Outcome|PII (M9)|Post dose 2, Month 9
1175808|NCT00370682|O3|Outcome|PII (M7)|Post dose 2, Month 7
1175809|NCT00370682|O2|Outcome|PI (M1)|Post dose1 , Month 1
1175810|NCT00370682|O1|Outcome|PRE Dose|Pre-dose 1
1175811|NCT00370682|O3|Outcome|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection~Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175812|NCT00370682|O2|Outcome|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months~T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175813|NCT00370682|O1|Outcome|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months~T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175814|NCT00370682|E3|Reported Event|Placebo Comparator|"0.5 mL sterile buffer at 0 and 6, subcutaneous injection~Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175815|NCT00370682|E2|Reported Event|T-DEN F19|"Full Dose (0.5 mL) at 0 and 6 months~T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175816|NCT00370682|E1|Reported Event|T-DEN F17|"Full Dose (0.5 mL) 0 and 6 months~T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months."
1175817|NCT00370552|B4|Baseline|Total|Total of all reporting groups
1175895|NCT00370292|O1|Outcome|Pemetrexed - Before Amendment|500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.
1175896|NCT00370292|O3|Outcome|dCK - Cycle 3|Mean dCK expression evaluated at Cycle 3.
1175818|NCT00370552|B3|Baseline|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175819|NCT00370552|B2|Baseline|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175820|NCT00370552|B1|Baseline|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175821|NCT00370552|P3|Participant Flow|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175958|NCT00369967|O2|Outcome|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
1175959|NCT00369967|O1|Outcome|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
1175960|NCT00369967|O2|Outcome|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
1175822|NCT00370552|P2|Participant Flow|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175823|NCT00370552|P1|Participant Flow|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175824|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175825|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175826|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175827|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175828|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175829|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175897|NCT00370292|O2|Outcome|dCK - Cycle 2|Mean dCK expression evaluated at Cycle 2.
1175898|NCT00370292|O1|Outcome|dCK - Cycle 1|Mean dCK expression evaluated at Cycle 1.
1175899|NCT00370292|E1|Reported Event|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles (pre-amendement) or 21 days x 6 cycles (post-amendment) or disease progression, unacceptable toxicity or patient decision to discontinue.
1175830|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175831|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175832|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175833|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175834|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175835|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175836|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175837|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175838|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175839|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175840|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175841|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175842|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175843|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175844|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175845|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175905|NCT00370149|O2|Outcome|Conventional Non-impegnated Catheters (C/S)|Patients randomized to this arm had the C/S inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1 C/S). The catheters were one of two sizes to accommodate children in different size ranges: Cook Incorporated Double Lumen Polyurethane Central Venous Catheters,4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J) 5 Fr.,12 cm long, (C-UDLM-501J-RSC).
1176121|NCT00369928|B4|Baseline|Total|Total of all reporting groups
1175846|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175847|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175848|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175849|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175850|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175851|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175852|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175853|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175854|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175900|NCT00370149|B3|Baseline|Total|Total of all reporting groups
1175901|NCT00370149|B2|Baseline|Conventional Non-impregnated Catheters (C/S)|Patients randomized to this arm had the C/S inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1 C/S). The catheters were one of two sizes to accommodate children in different size ranges: Cook Incorporated Double Lumen Polyurethane Central Venous Catheters,4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J), or 5 Fr., 12 cm long, (C-UDLM-501J RSC).
1175855|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175856|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175857|NCT00370552|E3|Reported Event|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175858|NCT00370552|E2|Reported Event|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity. After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone, as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175859|NCT00370552|E1|Reported Event|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone, as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
1175860|NCT00370331|B3|Baseline|Total|Total of all reporting groups
1175861|NCT00370331|B2|Baseline|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
1175862|NCT00370331|B1|Baseline|Placebo|Matching placebo tablets taken once a day
1175863|NCT00370331|P2|Participant Flow|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
1175864|NCT00370331|P1|Participant Flow|Placebo|Matching placebo tablets taken once a day
1175865|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
1175866|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
1175867|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
1175868|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
1175869|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
1175870|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
1175871|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
1175872|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
1175873|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
1175874|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
1175875|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
1175876|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
1175877|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
1175878|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
1175879|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
1175880|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
1175881|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
1175882|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
1175883|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
1175884|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
1175885|NCT00370331|E2|Reported Event|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
1175886|NCT00370331|E1|Reported Event|Placebo|Matching placebo tablets taken once a day
1175887|NCT00370292|B3|Baseline|Total|Total of all reporting groups
1175888|NCT00370292|B2|Baseline|Pemetrexed - After Amendment|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 6 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.
1175889|NCT00370292|B1|Baseline|Pemetrexed - Before Amendment|500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.
1175890|NCT00370292|P1|Participant Flow|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles (pre-amendement) or 21 days x 6 cycles (post-amendment) or disease progression, unacceptable toxicity or patient decision to discontinue.
1175891|NCT00370292|O3|Outcome|hENT - Cycle 3|Mean hENT expression evaluated at Cycle 3.
1175892|NCT00370292|O2|Outcome|hENT - Cycle 2|Mean hENT expression evaluated at Cycle 2.
1175893|NCT00370292|O1|Outcome|hENT - Cycle 1|Mean hENT expression evaluated at Cycle 1.
1175894|NCT00370292|O2|Outcome|Pemetrexed - After Amendment|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 6 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.
1176189|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
1175902|NCT00370149|B1|Baseline|Antibiotic Impregnated Catheters (M/R)|Patients randomized to this arm had the M/R inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1C/S). The catheters were sized to accommodate children in different size ranges: Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM) and C-UDLM-401J-ABRM-HC), 5 Fr., 8 cm long, (C-UDLM-501J-ABRM-HC), and 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM-HC).
1175903|NCT00370149|P2|Participant Flow|Conventional Non-impregnated Catheters (C/S)|Randomization to 2 arms of the study were on a blinded a 1:1 allocation. Patients randomized to this arm had the conventional Central Venous Catheter (C/S) with no antibiotic coating inserted intraoperatively. The specific catheters are the Cook Incorporated Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J), and 5 Fr., 12 cm long, (C-UDLM-501J-RSC).
1175904|NCT00370149|P1|Participant Flow|Antibiotic Impregnated Catheters (M/R)|Randomization to the 2 arms of the study were on a blinded a 1:1 allocation. Patients randomized to M/R had the catheter impregnated with minocycline and rifampin (M/R) inserted intraoperatively. The specific Central Venous Catheters are the Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM), 5 Fr., 8 cm long, (C-UDLM-501J-ABRM-HC), and 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM).
1175957|NCT00369967|O1|Outcome|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
1176345|NCT00369486|B6|Baseline|Total|Total of all reporting groups
1175906|NCT00370149|O1|Outcome|Antibiotic Impregnated Catheters (M/R)|Patients randomized to this arm had the M/R inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1C/S). The catheters were one of two sizes to accommodate children in different size ranges: Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM), ), 5 Fr., 8 cm long, (C-UDLM-501J-ABRM-HC) or 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM).
1175907|NCT00370149|O2|Outcome|Conventional Non-impregnated Catheters (C/S)|Patients randomized to this arm had the C/S inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1 C/S). The catheters were one of two sizes to accommodate children in different size ranges: Cook Incorporated Double Lumen Polyurethane Central Venous Catheters,4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J), 5 Fr., 12 cm long, (C-UDLM-501J-RSC).
1175908|NCT00370149|O1|Outcome|Antibiotic Impregnated Catheters (M/R)|Patients randomized to this arm had the M/R inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1C/S). The catheters were one of two sizes to accommodate children in different size ranges: Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM), ), 5 Fr., 8 cm long, (C-UDLM-501J-ABRM-HC) or 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM).
1175909|NCT00370149|O2|Outcome|Conventional Non-impregnated Catheters (C/S)|Patients randomized to this arm had the C/S inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1 C/S). The catheters were one of two to accommodate children in different size ranges: Cook Incorporated Double Lumen Polyurethane Central Venous Catheters,4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J), or 5 Fr., 12 cm long, (C-UDLM-501J-RSC).
1175910|NCT00370149|O1|Outcome|Antibiotic Impregnated Catheters (M/R)|Patients randomized to this arm had the M/R inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1C/S). The catheters were one of two to accommodate children in different size ranges: Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM), 5 Fr. 8 cm long, (C-UDLM-501J-ABRM-HC), or 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM).
1175911|NCT00370149|E2|Reported Event|Conventional Non-impregnated Catheters (C/S)|Randomization to 2 arms of the study were on a blinded a 1:1 allocation with the objective of determining if there was a therapeutic difference between the M/R and C/S catheters. Patients randomized to this arm had the C/S inserted intra-operatively. Patients receiving this catheter were enrolled in the study.The specific catheters are the Cook Incorporated Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J), 5 Fr., 12 cm long, (C-UDLM-501J-RSC). Patients were followed for adverse device affects and adverse events through their hospitalization stay
1175912|NCT00370149|E1|Reported Event|Antibiotic Impregnated Catheters (M/R)|Randomization to the 2 arms of the study were on a blinded a 1:1 allocation with the objective of determining if a therapeutic difference existed between M/R and C/S catheters. Patients randomized to this Arm had the M/R catheter inserted intra-operatively. Patients receiving this Catheter were enrolled in the study. The specific CVCs are the Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM), 5 Fr., 8 cm long, (C-UDLM-501J-ABRM-HC), and 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM-HC). Patients were followed for adverse device affects and adverse events through their hospitalization stay.
1175913|NCT00370071|B1|Baseline|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 micrograms (8 MIU [million international units]) subcutaneously every other day.
1175914|NCT00370071|P1|Participant Flow|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
1175915|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
1175916|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
1175917|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
1175918|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
1175919|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
1175920|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
1175921|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
1175922|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
1175924|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
1175925|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
1175926|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
1175927|NCT00370071|E1|Reported Event|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
1175928|NCT00370032|B3|Baseline|Total|Total of all reporting groups
1175929|NCT00370032|B2|Baseline|Healthy Volunteers|Volunteers without clinical disease. This group was randomize to EITHER 0.5 mb BID Alosetron or Placebo for 6 days followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then the subjects who were given study drug the first treatment period were given Placebo and vice versa for the next 6 days followed by another wash out period and a 7 day follow up period.
1175930|NCT00370032|B1|Baseline|d-IBS|Diarrhea-predominant irritable bowel syndrome. This group was randomize to EITHER 0.5 mb BID Alosetron or Placebo for 6 days followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then the subjects who were given study drug the first treatment period were given Placebo and vice versa for the next 6 days followed by another wash out period and a 7 day follow up period.
1175931|NCT00370032|P2|Participant Flow|Healthy Volunteers|Subjects with no clinical disease. This group was randomize to EITHER 0.5 mg BID Alosetron or Placebo for 6 days followed by flexible sigmoidoscopy then had a 7 day washout period; Then the subjects who were given study drug the first treatment period were given Placebo and vice versa for the next 6 days followed by another 7 day wash out period and a 7 day follow up period.
1175932|NCT00370032|P1|Participant Flow|d-IBS (Diarrhea Predominant - Irritable Bowel Syndrome)|Subjects with diarrhea-predominant irritable bowel syndrome. This group was randomize to EITHER 0.5 mg BID Alosetron or Placebo for 6 days followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then the subjects who were given study drug the first treatment period were given Placebo and vice versa for the next 6 days followed by a flexible sigmoidoscopy then had a 7 day follow up period.
1175933|NCT00370032|O4|Outcome|Healthy Volunteers Placebo - Rectal|Subjects without clinical disease. Modified per protocol. Subjects Rectal Mucosal blow flow under placebo.
1175934|NCT00370032|O3|Outcome|Healthy Volunteers Placebo - Left Colon|Subjects without Clinical disease. Modified per protocol. Subjects Left Colon Mucosal blow flow under placebo.
1175935|NCT00370032|O2|Outcome|d-IBS Placebo - Rectal|Subjects with diarrhea-predominant irritable bowel syndrome. Modified per protocol. Subjects Rectal Mucosal blow flow under placebo.
1175936|NCT00370032|O1|Outcome|d-IBS Placebo - Left Colon|Subjects with diarrhea-predominant irritable bowel syndrome . Modified per protocol. Subjects Left Colon Mucosal blow flow under placebo.
1175937|NCT00370032|O4|Outcome|Healthy Volunteers Alosetron|Subjects without clinical disease. In Treatment Period 1 this group was randomized to 0.5 mb BID Alosetron for 5days and 1 dose on the 6th day followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then,in Treatment Period 2 the subjects were given Placebo for the next 6 days followed by another 7 day wash out period and a 7 day follow up period.
1175938|NCT00370032|O3|Outcome|Healthy Volunteers Placebo|Subjects without Clinical disease. In Treatment Period 1 this group was first randomized to Placebo for 6 days followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then, in Treatment Period 2 the subjects were given Alosetron 0.5 mg (BID)for 5 days and on the 6th day one dose and a flexible sigmoidoscopy; followed by another wash out period of 7 days and a 7 day follow up period.
1175939|NCT00370032|O2|Outcome|d-IBS Alosetron|Subjects with diarrhea-predominant irritable bowel syndrome. In Treatment Period 1 this group was randomized to 0.5 mb BID Alosetron for 5days and 1 dose on the 6th day followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then, in Treatment Period 2 the subjects were given Placebo for the next 6 days followed by another 7 day wash out period and a 7 day follow up period.
1175940|NCT00370032|O1|Outcome|d-IBS Placebo|Subjects with diarrhea-predominant irritable bowel syndrome. In Treatment Period 1 this group was first randomized to Placebo for 6 days followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then, in Treatment Period 2 the subjects were given Alosetron 0.5 mg (BID)for 5 days and on the 6th day one dose and a flexible sigmoidoscopy; followed by another wash out period of 7 days and a 7 day follow up period.
1175941|NCT00370032|O4|Outcome|Healthy Volunteers Alosetron|Subjects without clinical disease. In Treatment Period 1 this group was randomized to 0.5 mb BID Alosetron for 5days and 1 dose on the 6th day followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then,in Treatment Period 2 the subjects were given Placebo for the next 6 days followed by another 7 day wash out period and a 7 day follow up period.
1175942|NCT00370032|O3|Outcome|Healthy Volunteers Placebo|Subjects without Clinical disease. In Treatment Period 1 this group was first randomized to Placebo for 6 days followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then, in Treatment Period 2 the subjects were given Alosetron 0.5 mg (BID)for 5 days and on the 6th day one dose and a flexible sigmoidoscopy; followed by another wash out period of 7 days and a 7 day follow up period.
1175943|NCT00370032|O2|Outcome|d-IBS Alosetron|Subjects with diarrhea-predominant irritable bowel syndrome. In Treatment Period 1, this group was randomized to 0.5 mb BID Alosetron for 5days and 1 dose on the 6th day followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then, in Treatment Period 2 the subjects were given Placebo for the next 6 days followed by another 7 day wash out period and a 7 day follow up period.
1175944|NCT00370032|O1|Outcome|d-IBS Placebo|Subjects with diarrhea-predominant irritable bowel syndrome. In Treatment Period 1 this group was first randomized to Placebo for 6 days followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then, in Treatment Period 2 the subjects were given Alosetron 0.5 mg (BID)for 5 days and on the 6th day one dose and a flexible sigmoidoscopy; followed by another wash out period of 7 days and a 7 day follow up period.
1175945|NCT00370032|E4|Reported Event|Healthy Volunteers Alosetron|Volunteers without clinical disease. Participants receiving 0.5 mb Alosetron BID in either the first or second 6-day treatment period. Both treatment periods were followed by a 7-day washout period; the second washout period was followed by a 7-day follow up period.
1176156|NCT00369824|P2|Participant Flow|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
1183694|NCT00349908|O2|Outcome|Group 2|Aneurysm Arm
1175946|NCT00370032|E3|Reported Event|Healthy Volunteers Placebo|Volunteers without clinical disease. Participants receiving 0.5 mb Placebo BID in either the first or second 6-day treatment period. Both treatment periods were followed by a 7-day washout period; the second washout period was followed by a 7-day follow up period.
1175947|NCT00370032|E2|Reported Event|d-IBS Alosetron|Diarrhea-predominant irritable bowel syndrome. Participants receiving 0.5 mb Alosetron BID in either the first or second 6-day treatment period. Both treatment periods were followed by a 7-day washout period; the second washout period was followed by a 7-day follow up period.
1175948|NCT00370032|E1|Reported Event|d-IBS Placebo|Diarrhea-predominant irritable bowel syndrome. Participants receiving 0.5 mb Placebo BID in either the first or second 6-day treatment period. Both treatment periods were followed by a 7-day washout period; the second washout period was followed by a 7-day follow up period.
1175949|NCT00369967|B3|Baseline|Total|Total of all reporting groups
1175950|NCT00369967|B2|Baseline|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
1175951|NCT00369967|B1|Baseline|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
1175952|NCT00369967|P2|Participant Flow|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
1175953|NCT00369967|P1|Participant Flow|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
1175954|NCT00369967|O2|Outcome|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
1175955|NCT00369967|O1|Outcome|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
1175956|NCT00369967|O2|Outcome|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
1175961|NCT00369967|O1|Outcome|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
1175962|NCT00369967|O2|Outcome|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
1175963|NCT00369967|O1|Outcome|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
1175964|NCT00369967|O2|Outcome|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception
1175965|NCT00369967|O1|Outcome|Quick Start|"Start method day of enrollment~NuvaRing: Initiation of NuvaRing for contraception"
1175966|NCT00369967|E2|Reported Event|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
1175967|NCT00369967|E1|Reported Event|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
1175968|NCT00369941|B3|Baseline|Total|Total of all reporting groups
1175969|NCT00369941|B2|Baseline|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1175970|NCT00369941|B1|Baseline|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1175971|NCT00369941|P2|Participant Flow|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1175972|NCT00369941|P1|Participant Flow|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1175973|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1175974|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1175975|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176157|NCT00369824|P1|Participant Flow|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
1176158|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
1176236|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
1175976|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1175977|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1175978|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1175979|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1175980|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1175981|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1175982|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1175983|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1175984|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1175985|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1175986|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1175987|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1175988|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1175989|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176159|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
1176160|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
1176161|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
1175990|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1175991|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1175992|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1175993|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1175994|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1175995|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1175996|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1175997|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1175998|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1175999|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176000|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176001|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176002|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176003|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176162|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
1176163|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
1176164|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
1176004|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176005|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176006|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176007|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176008|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176009|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176010|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176011|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176012|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176013|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176014|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176015|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176016|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176017|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176165|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
1176166|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
1176167|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
1176018|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176019|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176020|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176021|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176022|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176023|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176024|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176025|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176026|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176027|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176028|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176029|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176030|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176031|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176168|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
1176169|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
1176170|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
1176032|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176033|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176034|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176035|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176036|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176037|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176038|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176039|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176040|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176041|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176042|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176043|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176044|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176045|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176171|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
1176172|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
1176173|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
1176046|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176047|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176048|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176049|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176050|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176051|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176052|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176053|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176054|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176055|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176056|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176057|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176058|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176059|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176174|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
1176175|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
1176176|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
1176060|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176061|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176062|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176063|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176064|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176065|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176066|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176067|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176068|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176069|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176070|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176071|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176072|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176073|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176177|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
1176178|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
1176179|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
1176074|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176075|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176076|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176077|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176078|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176079|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176080|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176081|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176082|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176083|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176084|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176085|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176086|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176087|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176180|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
1176181|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
1176182|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
1176088|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176089|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176090|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176091|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176092|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176093|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176094|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176095|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176096|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176097|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176098|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176099|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176100|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176101|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176183|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
1176184|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
1176185|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
1176102|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176103|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176104|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176105|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176106|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176107|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176108|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176109|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176110|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176111|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176112|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176113|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176114|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176115|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176186|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
1176187|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
1176188|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
1176116|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176117|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176118|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176119|NCT00369941|E2|Reported Event|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg taken by mouth on an empty stomach preferably at bedtime (q.h.s.), and placebo to MK-0518 taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176120|NCT00369941|E1|Reported Event|MK-0518 400 mg b.i.d.|MK-0518 400 mg taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, taken PO (q.h.s.) on an empty stomach preferably at bedtime (q.h.s.). All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) daily with food with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
1176122|NCT00369928|B3|Baseline|100 mg PG-760564 BID|100 mg BID, of oral PG-760564
1176123|NCT00369928|B2|Baseline|25 mg PG-760564 BID|25 mg BID, of oral PG-760564
1176124|NCT00369928|B1|Baseline|Placebo|Placebo, oral dose, BID
1176125|NCT00369928|P3|Participant Flow|100 mg PG-760564 BID|100 mg BID, of oral PG-760564
1176126|NCT00369928|P2|Participant Flow|25 mg PG-760564 BID|25 mg BID, of oral PG-760564
1176127|NCT00369928|P1|Participant Flow|Placebo|Placebo, oral dose, BID
1176128|NCT00369928|O3|Outcome|100 mg PG-760564 BID|100 mg BID, of oral PG-760564
1176129|NCT00369928|O2|Outcome|25 mg PG-760564 BID|25 mg BID, of oral PG-760564
1176130|NCT00369928|O1|Outcome|Placebo|Placebo, oral dose, BID
1176131|NCT00369928|E3|Reported Event|100 mg PG-760564 BID|100 mg BID, of oral PG-760564
1176132|NCT00369928|E2|Reported Event|25 mg PG-760564 BID|25 mg BID, of oral PG-760564
1176133|NCT00369928|E1|Reported Event|Placebo|Placebo, oral dose, BID
1176134|NCT00369915|B3|Baseline|Total|Total of all reporting groups
1176135|NCT00369915|B2|Baseline|Scop/Plac|6 administrations of scopolamine patch at 4 to 5 day intervals; followed by 6 administrations of placebo patch at 4 to 5 day intervals
1176136|NCT00369915|B1|Baseline|Plac/Scop|6 administrations of placebo patch at 4 to 5 day intervals; followed by 6 administrations of scopolamine patch at 4 to 5 day intervals
1176137|NCT00369915|P2|Participant Flow|Scop/Plac|6 administrations of scopolamine patch at 4 to 5 day intervals; followed by 6 administrations of placebo patch at 4 to 5 day intervals
1176138|NCT00369915|P1|Participant Flow|Plac/Scop|6 administrations of placebo patch at 4 to 5 day intervals; followed by 6 administrations of scopolamine patch at 4 to 5 day intervals
1176139|NCT00369915|O2|Outcome|Scop/Plac|6 administrations of scopolamine patch at 4 to 5 day intervals; followed by 6 administrations of placebo patch at 4 to 5 day intervals
1176140|NCT00369915|O1|Outcome|Plac/Scop|6 administrations of placebo patch at 4 to 5 day intervals; followed by 6 administrations of scopolamine patch at 4 to 5 day intervals
1176141|NCT00369915|O2|Outcome|Scop/Plac|6 administrations of scopolamine patch at 4 to 5 day intervals; followed by 6 administrations of placebo patch at 4 to 5 day intervals
1176142|NCT00369915|O1|Outcome|Plac/Scop|6 administrations of placebo patch at 4 to 5 day intervals; followed by 6 administrations of scopolamine patch at 4 to 5 day intervals
1176143|NCT00369915|E2|Reported Event|Scop/Plac|6 administrations of scopolamine patch at 4 to 5 day intervals; followed by 6 administrations of placebo patch at 4 to 5 day intervals
1176144|NCT00369915|E1|Reported Event|Plac/Scop|6 administrations of placebo patch at 4 to 5 day intervals; followed by 6 administrations of scopolamine patch at 4 to 5 day intervals
1176145|NCT00369824|B7|Baseline|Total|Total of all reporting groups
1176146|NCT00369824|B6|Baseline|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
1176147|NCT00369824|B5|Baseline|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
1176148|NCT00369824|B4|Baseline|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
1176149|NCT00369824|B3|Baseline|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
1176150|NCT00369824|B2|Baseline|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
1176151|NCT00369824|B1|Baseline|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
1176152|NCT00369824|P6|Participant Flow|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
1176153|NCT00369824|P5|Participant Flow|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
1176154|NCT00369824|P4|Participant Flow|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
1176155|NCT00369824|P3|Participant Flow|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
1176190|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
1176191|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
1176192|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
1176193|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
1176194|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
1176195|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
1176196|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
1176197|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
1176198|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
1176199|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
1176200|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
1176201|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
1176202|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
1176203|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
1176204|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
1176425|NCT00369343|B3|Baseline|Total|Total of all reporting groups
1176205|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
1176206|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
1176207|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
1176208|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
1176209|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
1176210|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
1176211|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
1176212|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
1176213|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
1176214|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
1176215|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
1176216|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
1176217|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
1176218|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
1176219|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
1176220|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
1176221|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
1176222|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
1176223|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
1176224|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
1176225|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
1176226|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
1176227|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
1176228|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
1176229|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
1176230|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
1176231|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
1176232|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
1176233|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
1176234|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
1176235|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
1176237|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
1176238|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
1176239|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
1176240|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
1176241|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
1176242|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
1176243|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
1176244|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
1176245|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
1176246|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
1176247|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
1176248|NCT00369824|E6|Reported Event|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
1176249|NCT00369824|E5|Reported Event|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
1176250|NCT00369824|E4|Reported Event|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
1176251|NCT00369824|E3|Reported Event|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
1176252|NCT00369824|E2|Reported Event|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
1176253|NCT00369824|E1|Reported Event|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
1176254|NCT00369785|B3|Baseline|Total|Total of all reporting groups
1176255|NCT00369785|B2|Baseline|Arm II - Control|"Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day~Placebo: Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day"
1176256|NCT00369785|B1|Baseline|Arm I - Donepezil|"Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day~donepezil hydrochloride: Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily"
1176257|NCT00369785|P2|Participant Flow|Arm II - Control|"Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day~Placebo: Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day"
1176258|NCT00369785|P1|Participant Flow|Arm I - Donepezil|"Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day~donepezil hydrochloride: Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily"
1176259|NCT00369785|O2|Outcome|Arm II - Control|"Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day~Placebo: Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day"
1176260|NCT00369785|O1|Outcome|Arm I - Donepezil|"Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day~donepezil hydrochloride: Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily"
1176261|NCT00369785|O2|Outcome|Arm II - Control|"Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day~Placebo: Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day"
1176262|NCT00369785|O1|Outcome|Arm I - Donepezil|"Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day~donepezil hydrochloride: Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily"
1176263|NCT00369785|E2|Reported Event|Arm II - Control|"Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day~Placebo: Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day"
1176264|NCT00369785|E1|Reported Event|Arm I - Donepezil|"Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day~donepezil hydrochloride: Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily"
1176265|NCT00369746|B3|Baseline|Total|Total of all reporting groups
1176266|NCT00369746|B2|Baseline|Major Depression Only|Major Depression without alcohol abuse disorder
1176267|NCT00369746|B1|Baseline|Alcohol Abuse or Dependence|Subjects with alcohol abuse or dependence
1176268|NCT00369746|P2|Participant Flow|Major Depression Only|Major Depression without alcohol abuse disorder
1176269|NCT00369746|P1|Participant Flow|Alcohol Abuse or Dependence|Subjects with alcohol abuse or dependence and Major Depression
1176270|NCT00369746|O1|Outcome|Alcoholic|Subjects with alcohol abuse or dependence
1176271|NCT00369746|O1|Outcome|Alcoholic|Subjects with alcohol abuse or dependence
1176272|NCT00369746|O1|Outcome|Alcoholic|Subjects with alcohol abuse or dependence
1176273|NCT00369746|O1|Outcome|Alcoholic|Subjects with alcohol abuse or dependence
1176274|NCT00369746|O2|Outcome|Major Depression Only|citalopram (Non alcoholic)
1176275|NCT00369746|O1|Outcome|Alcoholic|Subjects with alcohol abuse or dependence
1176276|NCT00369746|E2|Reported Event|Major Depression Only|Major Depression without alcohol abuse disorder
1176277|NCT00369746|E1|Reported Event|Alcohol Abuse or Dependence|Subjects with alcohol abuse or dependence
1176278|NCT00369681|B1|Baseline|R-ABVD|ABVD (Adriamycin/doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m^2 Cycles 2, 4, and 6 Day 1.
1176279|NCT00369681|P1|Participant Flow|R-ABVD|ABVD (Adriamycin/doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m^2 Cycles 2, 4, and 6 Day 1.
1176862|NCT00368069|O1|Outcome|Keppra®|Keppra® extended release formulation (XR)
1176280|NCT00369681|O1|Outcome|R-ABVD|ABVD (Adriamycin/doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m^2 Cycles 2, 4, and 6 Day 1.
1176281|NCT00369681|O2|Outcome|Re-emergence of Clone|Participants who did have re-emergence of clonal CD27(+) ALDH(+) B cells
1176282|NCT00369681|O1|Outcome|No Clone|Participants who did not have re-emergence of clonal CD27(+) ALDH(+) B cells
1176283|NCT00369681|E1|Reported Event|R-ABVD|ABVD (Adriamycin/doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m^2 Cycles 2, 4, and 6 Day 1.
1176284|NCT00369668|B4|Baseline|Total|Total of all reporting groups
1176285|NCT00369668|B3|Baseline|Control|Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation.
1176286|NCT00369668|B2|Baseline|Low Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.
1176287|NCT00369668|B1|Baseline|High Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.
1176288|NCT00369668|P3|Participant Flow|Control|Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation.
1176289|NCT00369668|P2|Participant Flow|Low Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.
1176290|NCT00369668|P1|Participant Flow|High Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.
1176291|NCT00369668|O3|Outcome|Control|Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation
1176292|NCT00369668|O2|Outcome|Low Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.
1176293|NCT00369668|O1|Outcome|High Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.
1176294|NCT00369668|O3|Outcome|Control|Bilateral movements coupled with sham neuromuscular electrical stimulation. Two times per week for two weeks.
1176295|NCT00369668|O2|Outcome|Low Intensity|Bilateral movements coupled with neuromuscular electrical stimulation. Two times per week for two weeks.
1176296|NCT00369668|O1|Outcome|High Intensity|Bilateral movements coupled with neuromuscular electrical stimulation. Four times per week for two weeks.
1176297|NCT00369668|O3|Outcome|Control|Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation
1176298|NCT00369668|O2|Outcome|Low Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.
1176299|NCT00369668|O1|Outcome|High Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.
1176300|NCT00369668|E3|Reported Event|Control|Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation.
1176301|NCT00369668|E2|Reported Event|Low Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.
1176302|NCT00369668|E1|Reported Event|High Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.
1176303|NCT00369655|B1|Baseline|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
1176304|NCT00369655|P1|Participant Flow|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
1176305|NCT00369655|O1|Outcome|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
1176306|NCT00369655|O1|Outcome|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
1176307|NCT00369655|O1|Outcome|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
1176308|NCT00369655|O1|Outcome|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
1176309|NCT00369655|O1|Outcome|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
1176310|NCT00369655|O1|Outcome|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
1176311|NCT00369655|E1|Reported Event|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
1176312|NCT00369590|B3|Baseline|Total|Total of all reporting groups
1176313|NCT00369590|B2|Baseline|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
1176314|NCT00369590|B1|Baseline|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
1176315|NCT00369590|P2|Participant Flow|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
1176371|NCT00369486|O5|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
1176316|NCT00369590|P1|Participant Flow|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
1176317|NCT00369590|O2|Outcome|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
1176318|NCT00369590|O1|Outcome|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
1176319|NCT00369590|O2|Outcome|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
1176320|NCT00369590|O1|Outcome|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
1176321|NCT00369590|O2|Outcome|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
1187531|NCT00330967|O1|Outcome|Group 2|Femoral Intralipid infusion group
1176322|NCT00369590|O1|Outcome|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
1176323|NCT00369590|O2|Outcome|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
1176324|NCT00369590|O1|Outcome|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
1176325|NCT00369590|O2|Outcome|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
1176326|NCT00369590|O1|Outcome|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
1176327|NCT00369590|O2|Outcome|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
1176328|NCT00369590|O1|Outcome|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
1176329|NCT00369590|E1|Reported Event|All Study Patients|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
1176330|NCT00369564|B3|Baseline|Total|Total of all reporting groups
1176331|NCT00369564|B2|Baseline|Arm II Placebo|Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
1176332|NCT00369564|B1|Baseline|Arm I Glutamic Acid|Patients receive oral glutamic acid 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
1176333|NCT00369564|P2|Participant Flow|Arm II Placebo|"Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1). Placebo capsules are identical in appearance to the active oral glutamic acid capsules but instead each capsule contains 324 mg of microcrystalline cellulose as a filler, 3 mg of magnesium stearate as a lubricant and 3 mg silicone dioxide as a drying agent for a total fill weight of 330 mg. The manufacturer has certified that the placebo contains no active agent.~Patients with a body surface area (BSA) less than 1.0 m^2 will receive a 1 capsule of placebo 3 times daily (total 3 capsules daily). Patients with a body surface area (BSA) greater or equal to1.0 m^2 will receive a 2 placebo capsules 3 times daily (total 6 capsules daily). ."
1176334|NCT00369564|P1|Participant Flow|Arm I Glutamic Acid|Patients receive oral l-glutamic acid hydrocloride 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1). Patients with a body surface area (BSA) less than 1.0 m^2 will receive a total of 750 mg/day of oral glutamic acid . Patients with a body surface area (BSA) greater or equal to1.0 m^2 will receive a total of 1500 mg/day of oral glutamic acid .
1176863|NCT00368069|E2|Reported Event|Placebo|placebo
1176335|NCT00369564|O2|Outcome|Arm II Placebo|Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
1176336|NCT00369564|O1|Outcome|Arm I Glutamic Acid|Patients receive oral glutamic acid 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
1176337|NCT00369564|E2|Reported Event|Arm II Placebo|Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
1176338|NCT00369564|E1|Reported Event|Arm I Glutamic Acid|Patients receive oral glutamic acid 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
1176339|NCT00369512|B1|Baseline|Erlotinib|Erlotinib therapy for 2 weeks (150 mg once per day)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg once per day).
1176340|NCT00369512|P1|Participant Flow|Erlotinib|Erlotinib therapy for 2 weeks (150 mg by mouth (PO) every day(QD))(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
1176341|NCT00369512|O1|Outcome|Erlotinib|Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
1176342|NCT00369512|O1|Outcome|Erlotinib|Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
1176343|NCT00369512|O1|Outcome|Erlotinib|Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
1176344|NCT00369512|E1|Reported Event|Erlotinib|Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
1176346|NCT00369486|B5|Baseline|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
1176347|NCT00369486|B4|Baseline|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
1176348|NCT00369486|B3|Baseline|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
1176349|NCT00369486|B2|Baseline|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
1176350|NCT00369486|B1|Baseline|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
1176351|NCT00369486|P5|Participant Flow|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
1176352|NCT00369486|P4|Participant Flow|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
1176353|NCT00369486|P3|Participant Flow|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
1176354|NCT00369486|P2|Participant Flow|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
1176355|NCT00369486|P1|Participant Flow|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
1176356|NCT00369486|O5|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
1176357|NCT00369486|O4|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
1176358|NCT00369486|O3|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
1176359|NCT00369486|O2|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
1176360|NCT00369486|O1|Outcome|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
1176361|NCT00369486|O5|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
1176362|NCT00369486|O4|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
1176363|NCT00369486|O3|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
1176364|NCT00369486|O2|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
1176365|NCT00369486|O1|Outcome|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
1176366|NCT00369486|O5|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
1176367|NCT00369486|O4|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
1176368|NCT00369486|O3|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
1176369|NCT00369486|O2|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
1176370|NCT00369486|O1|Outcome|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
1176864|NCT00368069|E1|Reported Event|Keppra®|Keppra® extended release formulation (XR)
1176372|NCT00369486|O4|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
1176373|NCT00369486|O3|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
1176374|NCT00369486|O2|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
1176375|NCT00369486|O1|Outcome|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
1176376|NCT00369486|O5|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
1176377|NCT00369486|O4|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
1176378|NCT00369486|O3|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
1176379|NCT00369486|O2|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
1176380|NCT00369486|O1|Outcome|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
1176381|NCT00369486|O5|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
1176382|NCT00369486|O4|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
1176383|NCT00369486|O3|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
1176384|NCT00369486|O2|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
1187532|NCT00330967|O1|Outcome|Group 2|Femoral Intralipid infusion group
1176385|NCT00369486|O1|Outcome|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
1176386|NCT00369486|E5|Reported Event|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
1176387|NCT00369486|E4|Reported Event|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
1176388|NCT00369486|E3|Reported Event|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
1176389|NCT00369486|E2|Reported Event|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
1176390|NCT00369486|E1|Reported Event|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
1176391|NCT00369382|B3|Baseline|Total|Total of all reporting groups
1176392|NCT00369382|B2|Baseline|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
1176393|NCT00369382|B1|Baseline|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
1176394|NCT00369382|P2|Participant Flow|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
1176395|NCT00369382|P1|Participant Flow|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
1176396|NCT00369382|O1|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
1176397|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
1176398|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
1176399|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
1176400|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
1176865|NCT00367991|B3|Baseline|Total|Total of all reporting groups
1176401|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
1176402|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
1176403|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
1176404|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
1176405|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
1176406|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
1187533|NCT00330967|O1|Outcome|Group 2|Femoral Intralipid infusion group
1176407|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
1176408|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
1176409|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
1176410|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
1176411|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
1176412|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
1176413|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
1176414|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
1176415|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
1176416|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
1176417|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
1176418|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
1176458|NCT00369343|E3|Reported Event|Open-label DVS SR/ DVS SR|Patients were in the DVS SR arm during both the double-blind and open-label phase.
1176459|NCT00369343|E2|Reported Event|Double-blind Placebo|Placebo administered daily for 8 weeks
1176419|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
1176420|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
1176421|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
1176422|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
1176423|NCT00369382|E2|Reported Event|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
1176424|NCT00369382|E1|Reported Event|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
1176426|NCT00369343|B2|Baseline|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
1176427|NCT00369343|B1|Baseline|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
1176428|NCT00369343|P2|Participant Flow|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
1176429|NCT00369343|P1|Participant Flow|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
1176430|NCT00369343|O3|Outcome|200 mg|DVS SR 200mg dosage was reduced to DVS SR 100mg for 7 days and then further reduced to DVS SR 50mg from days 8 to 14.
1176431|NCT00369343|O2|Outcome|100 mg|DVS SR 100mg dosage was reduced to DVS SR 50mg for 7 days.
1176432|NCT00369343|O1|Outcome|0 mg|Placebo
1176433|NCT00369343|O2|Outcome|Placebo / DVS SR|Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
1176434|NCT00369343|O1|Outcome|DVS SR / DVS SR|Patients were in the DVS SR arm during both the double-blind and open-label phase.
1176435|NCT00369343|O2|Outcome|Placebo / DVS SR|Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
1176436|NCT00369343|O1|Outcome|DVS SR / DVS SR|Patients were in the DVS SR arm during both the double-blind and open-label phase.
1176437|NCT00369343|O2|Outcome|Placebo / DVS SR|Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
1176438|NCT00369343|O1|Outcome|DVS SR / DVS SR|Patients were in the DVS SR arm during both the double-blind and open-label phase.
1176439|NCT00369343|O2|Outcome|Placebo / DVS SR|Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
1176440|NCT00369343|O1|Outcome|DVS SR / DVS SR|Patients were in the DVS SR arm during both the double-blind and open-label phase.
1176441|NCT00369343|O2|Outcome|Placebo / DVS SR|Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
1176442|NCT00369343|O1|Outcome|DVS SR / DVS SR|Patients were in the DVS SR arm during both the double-blind and open-label phase.
1176443|NCT00369343|O2|Outcome|Placebo / DVS SR|Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
1176444|NCT00369343|O1|Outcome|DVS SR / DVS SR|Patients were in the DVS SR arm during both the double-blind and open-label phase.
1176476|NCT00369278|O1|Outcome|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
1176445|NCT00369343|O2|Outcome|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
1176446|NCT00369343|O1|Outcome|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
1176447|NCT00369343|O2|Outcome|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
1176448|NCT00369343|O1|Outcome|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
1187534|NCT00330967|O1|Outcome|Group 2|Femoral Intralipid infusion group
1176449|NCT00369343|O2|Outcome|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
1176450|NCT00369343|O1|Outcome|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
1176451|NCT00369343|O2|Outcome|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
1176452|NCT00369343|O1|Outcome|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
1176453|NCT00369343|O2|Outcome|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
1176454|NCT00369343|O1|Outcome|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
1176455|NCT00369343|O2|Outcome|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
1176456|NCT00369343|O1|Outcome|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
1176457|NCT00369343|E4|Reported Event|Open-label Placebo/DVS SR|Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
1176460|NCT00369343|E1|Reported Event|Double-blind DVS SR|"Days 1 to 7:~Patients will be instructed to take 1-50mg tablet per day~Days 8 to 14:~Patients will be instructed to take 1-100mg tablet per day~Days 15 to 56:~At the discretion of the investigator, patients may be assigned to 100mg or 200mg tablets per day"
1176461|NCT00369317|B1|Baseline|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.~COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I~INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.~asparaginase: Given IM~daunorubicin hydrochloride: Given IV~cytarabine: Given IV or IT~thioguanine: Given orally~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
1176462|NCT00369317|P1|Participant Flow|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.~COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I~INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.~asparaginase: Given IM~daunorubicin hydrochloride: Given IV~cytarabine: Given IV or IT~thioguanine: Given orally~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
1176490|NCT00369265|E2|Reported Event|Lansoprazole|Lansoprazole 30 mg twice daily
1176491|NCT00369265|E1|Reported Event|Sugar Pill|Placebo for Lansoprazole twice daily
1176463|NCT00369317|O1|Outcome|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.~COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I~INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.~asparaginase: Given IM~daunorubicin hydrochloride: Given IV~cytarabine: Given IV or IT~thioguanine: Given orally~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
1176464|NCT00369317|O1|Outcome|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.~COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I~INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.~asparaginase: Given IM~daunorubicin hydrochloride: Given IV~cytarabine: Given IV or IT~thioguanine: Given orally~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
1176465|NCT00369317|E1|Reported Event|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.~COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I~INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.~asparaginase: Given IM~daunorubicin hydrochloride: Given IV~cytarabine: Given IV or IT~thioguanine: Given orally~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
1176466|NCT00369278|B3|Baseline|Total|Total of all reporting groups
1176467|NCT00369278|B2|Baseline|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
1176468|NCT00369278|B1|Baseline|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
1176469|NCT00369278|P2|Participant Flow|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
1176470|NCT00369278|P1|Participant Flow|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
1176471|NCT00369278|O2|Outcome|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
1176472|NCT00369278|O1|Outcome|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
1176473|NCT00369278|O2|Outcome|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
1176474|NCT00369278|O1|Outcome|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
1176475|NCT00369278|O2|Outcome|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
1176477|NCT00369278|O2|Outcome|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
1176478|NCT00369278|O1|Outcome|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
1176479|NCT00369278|O2|Outcome|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
1176480|NCT00369278|O1|Outcome|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
1176481|NCT00369278|E2|Reported Event|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study (month 6): 1440 mg/day (2 x 720 mg)
1176482|NCT00369278|E1|Reported Event|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
1176483|NCT00369265|B3|Baseline|Total|Total of all reporting groups
1176484|NCT00369265|B2|Baseline|Lansoprazole|Lansoprazole 30 mg twice daily
1176485|NCT00369265|B1|Baseline|Sugar Pill|Placebo for Lansoprazole twice daily
1176486|NCT00369265|P2|Participant Flow|Lansoprazole|Lansoprazole 30 mg twice daily
1176487|NCT00369265|P1|Participant Flow|Sugar Pill|Placebo for Lansoprazole twice daily
1176488|NCT00369265|O2|Outcome|Lansoprazole|Lansoprazole 30 mg twice daily
1176489|NCT00369265|O1|Outcome|Sugar Pill|Placebo for Lansoprazole twice daily
1176496|NCT00369226|P1|Participant Flow|Phase I (45 Days)|Bortezomib plus tacrolimus and methotrexate after mismatched allogeneic non-myeloablative hematopoietic stem cell transplantation (HSCT).
1176497|NCT00369226|O2|Outcome|Overall Survival (OS)|This reports on all treated patients across both phase I and phase II (n=45)
1176498|NCT00369226|O1|Outcome|Progression-free Survival (PFS)|This reports on all treated patients across both phase I and phase II (n=45)
1176499|NCT00369226|O1|Outcome|Phase I and Phase II|This reports on all treated patients across both phase I and phase II (n=45)
1176500|NCT00369226|O1|Outcome|Phase I and Phase II|Engraftment is determined for all treated patients across both phase I and phase II (n=45) who are evaluable for this endpoint (n=35)
1176501|NCT00369226|O1|Outcome|Phase I and Phase II|This reports on all treated patients across both phase I and phase II (n=45)
1176502|NCT00369226|O1|Outcome|Combined Phase I Plus Phase II|This reports on the total phase I plus phase II patients who were evaluable for chimerism endpoint (37 of the 45 patients).
1176503|NCT00369226|O1|Outcome|Phase I|
1176504|NCT00369226|E1|Reported Event|Phase I-II|
1176505|NCT00369161|B3|Baseline|Total|Total of all reporting groups
1176506|NCT00369161|B2|Baseline|Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
1176507|NCT00369161|B1|Baseline|Very Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
1176508|NCT00369161|P2|Participant Flow|Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
1176537|NCT00368979|O1|Outcome|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
1176538|NCT00368979|O2|Outcome|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
1176866|NCT00367991|B2|Baseline|Placebo|Normal saline volume to match active treatment IV daily for 3 days
1176509|NCT00369161|P1|Participant Flow|Very Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
1176510|NCT00369161|O2|Outcome|Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
1176518|NCT00369122|B1|Baseline|Treatment (Radiation Therapy, Bevacizumab, Cisplatin)|"Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy.~Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35."
1176584|NCT00368966|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
1176511|NCT00369161|O1|Outcome|Very Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
1176512|NCT00369161|O2|Outcome|Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
1176513|NCT00369161|O1|Outcome|Very Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
1176514|NCT00369161|O2|Outcome|Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
1176515|NCT00369161|O1|Outcome|Very Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
1176539|NCT00368979|O1|Outcome|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
1176540|NCT00368979|O2|Outcome|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
1176541|NCT00368979|O1|Outcome|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
1176542|NCT00368979|O2|Outcome|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
1176516|NCT00369161|E2|Reported Event|Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
1176517|NCT00369161|E1|Reported Event|Very Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
1176519|NCT00369122|P1|Participant Flow|Treatment (Radiation Therapy, Bevacizumab, Cisplatin)|"Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy.~Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35."
1176520|NCT00369122|O1|Outcome|Treatment (Radiation Therapy, Bevacizumab, Cisplatin)|"Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy.~Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35."
1176521|NCT00369122|E1|Reported Event|Treatment (Radiation Therapy, Bevacizumab, Cisplatin)|"Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy.~Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35.~Data is reported for all patients who received study treatment, which is 59 patients."
1176522|NCT00368992|B1|Baseline|Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab|This was a single arm Phase II trial. Patients were treated until progression.
1176523|NCT00368992|P1|Participant Flow|Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab|"This was a single arm Phase II trial. Patients were treated with induction therapy cetuximab IV over 1-2 hours on days 1, 8, and 15 and paclitaxel IV over 3 hours, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Patients who were not removed due to unacceptable toxicity or disease progression were then treated with maintenance therapy cetuximab IV over 1 hour on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity."
1176524|NCT00368992|O1|Outcome|Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab|
1176525|NCT00368992|O1|Outcome|Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab|This was a single arm Phase II trial. Patients were treated until progression.
1176526|NCT00368992|O1|Outcome|Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab|This was a single arm Phase II trial. Patients were treated until progression.
1176527|NCT00368992|O1|Outcome|Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab|
1176528|NCT00368992|E1|Reported Event|Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab|
1176529|NCT00368979|B3|Baseline|Total|Total of all reporting groups
1176530|NCT00368979|B2|Baseline|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
1176531|NCT00368979|B1|Baseline|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
1176532|NCT00368979|P2|Participant Flow|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
1176533|NCT00368979|P1|Participant Flow|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
1176534|NCT00368979|O2|Outcome|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
1176535|NCT00368979|O1|Outcome|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
1176536|NCT00368979|O2|Outcome|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
1183695|NCT00349908|O1|Outcome|Group 1|Atherosclerosis
1176543|NCT00368979|O1|Outcome|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
1176544|NCT00368979|E2|Reported Event|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
1176545|NCT00368979|E1|Reported Event|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
1176546|NCT00368966|B3|Baseline|Total|Total of all reporting groups
1176547|NCT00368966|B2|Baseline|7vPnC|Subjects received 1 dose (0.5 mL) of 7vPnC together with 1 dose (0.5 mL) of each of the following concomitant vaccines: Infanrix hexa and Meningitec at 2 and 4 months. At 6 months subjects received 7vPnC and Infanrix hexa. At 12 months subjects received MMR II. At 15 months subjects received 7vPnC and Infanrix-IPV+Hib, Meningitec.
1176548|NCT00368966|B1|Baseline|13vPnC|Subjects received 1 dose (0.5 mL) of 13vPnC together with 1 dose (0.5 mL) of each of the following concomitant vaccines: Infanrix hexa and Meningitec at 2 and 4 months. At 6 months subjects received 13vPnC and Infanrix hexa. At 12 months subjects received MMR II. At 15 months subjects received 13vPnC and Infanrix-IPV+Hib, Meningitec.
1176549|NCT00368966|P2|Participant Flow|7vPnC|Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a combination vaccine diphtheria, tetanus, and pertussis (acellular) vaccine (DTPa), hepatitis B virus vaccine (HBV), inactivated poliovirus (IPV), and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) and a meningococcal C conjugate vaccine (Meningitec) at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine measles, mumps, rubella live virus (MMR II) at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with DTPa, IPV, and Hib vaccine (Infanrix-IPV+Hib) and Meningitec at 15 months.
1176583|NCT00368966|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
1176612|NCT00368927|E2|Reported Event|Arm B (Placebo)|Patients receive oral placebo twice daily for 6 months.
1176550|NCT00368966|P1|Participant Flow|13vPnC|Participants received one single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with a combination vaccine diphtheria, tetanus, and pertussis (acellular) vaccine (DTPa), hepatitis B virus vaccine (HBV), inactivated poliovirus (IPV), and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) and a meningococcal C conjugate vaccine (Meningitec) at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine measles, mumps, rubella live virus (MMR II) at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with DTPa, IPV, and Hib vaccine (Infanrix-IPV+Hib) and Meningitec at 15 months.
1176551|NCT00368966|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
1176552|NCT00368966|O2|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
1176553|NCT00368966|O1|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
1176554|NCT00368966|O4|Outcome|7vPnC Afte the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
1176555|NCT00368966|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
1176556|NCT00368966|O2|Outcome|7vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
1176557|NCT00368966|O1|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
1176558|NCT00368966|O4|Outcome|7vPnC Afte the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
1176559|NCT00368966|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
1176560|NCT00368966|O2|Outcome|7vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
1176561|NCT00368966|O1|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
1176562|NCT00368966|O4|Outcome|7vPnC Afte the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
1176563|NCT00368966|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
1176564|NCT00368966|O2|Outcome|7vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
1176565|NCT00368966|O1|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
1176566|NCT00368966|O4|Outcome|7vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months.
1176567|NCT00368966|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
1176568|NCT00368966|O2|Outcome|7vPnC After Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
1176569|NCT00368966|O1|Outcome|13vPnC After Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
1176570|NCT00368966|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
1176571|NCT00368966|O2|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
1176745|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
1176572|NCT00368966|O1|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months (infant series).
1176573|NCT00368966|O8|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
1176574|NCT00368966|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
1176575|NCT00368966|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
1176576|NCT00368966|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
1176577|NCT00368966|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
1176578|NCT00368966|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
1176579|NCT00368966|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 months (infant series).
1176580|NCT00368966|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 months (infant series).
1176581|NCT00368966|O8|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
1176582|NCT00368966|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
1176585|NCT00368966|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
1176586|NCT00368966|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
1176587|NCT00368966|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 months (infant series).
1176588|NCT00368966|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 months (infant series).
1176589|NCT00368966|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
1176590|NCT00368966|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
1176591|NCT00368966|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
1176592|NCT00368966|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months(toddler dose).
1176593|NCT00368966|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
1176594|NCT00368966|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
1176595|NCT00368966|E8|Reported Event|7vPnC 6-Month Follow-up|Assessment was done approximately 6 months after 7vPnC toddler dose at 21 months of age.
1176596|NCT00368966|E7|Reported Event|13vPnC 6-Month Follow-up|Assessment was done approximately 6 months after 13vPnC toddler dose at 21 months of age.
1176597|NCT00368966|E6|Reported Event|7vPnC Toddler Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose). Assessment was done approximately one month after toddler dose at 16 months of age.
1176746|NCT00367679|O1|Outcome|Overall Study Arm|
1176747|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
1176598|NCT00368966|E5|Reported Event|13vPnC Toddler Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose). Assessment was done approximately one month after toddler dose at 16 months of age.
1176599|NCT00368966|E4|Reported Event|7vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months, assessment was done approximately one month after dose 3 at 7 months of age.
1176600|NCT00368966|E3|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series), assessment was done approximately one month after dose 3 at 7 months of age.
1176601|NCT00368966|E2|Reported Event|7vPnC Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months, assessment was done approximately one month after dose 2 at 5 months of age.
1176602|NCT00368966|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months, assessment was done approximately one month after dose 2 at 5 months of age.
1176603|NCT00368927|B3|Baseline|Total|Total of all reporting groups
1176604|NCT00368927|B2|Baseline|Arm B (Placebo)|Patients receive oral placebo twice daily for 6 months.
1176605|NCT00368927|B1|Baseline|Arm A (Sulindac)|Patients receive oral sulindac twice daily for 6 months.
1176606|NCT00368927|P2|Participant Flow|Arm B (Placebo)|Patients receive oral placebo twice daily for 6 months.
1176607|NCT00368927|P1|Participant Flow|Arm A (Sulindac)|Patients receive oral sulindac twice daily for 6 months.
1176608|NCT00368927|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo twice daily for 6 months.
1176609|NCT00368927|O1|Outcome|Arm A (Sulindac)|Patients receive oral sulindac twice daily for 6 months.
1176610|NCT00368927|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo twice daily for 6 months.
1176611|NCT00368927|O1|Outcome|Arm A (Sulindac)|Patients receive oral sulindac twice daily for 6 months.
1176613|NCT00368927|E1|Reported Event|Arm A (Sulindac)|Patients receive oral sulindac twice daily for 6 months.
1176614|NCT00368875|B1|Baseline|Phase I + Phase II|"Phase I: Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy.~Phase II: Vorinostat was administered orally twice daily at the recommended phase II dose of 300 mg on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose."
1176615|NCT00368875|P2|Participant Flow|Phase II|"Vorinostat was administered orally twice daily at the recommended phase II dose of 300 mg on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose."
1176616|NCT00368875|P1|Participant Flow|Phase I|"Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy."
1176617|NCT00368875|O1|Outcome|Phase I|"Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy."
1176618|NCT00368875|O1|Outcome|Vorinostat, Paclitaxel, Bevacizumab|"Vorinostat BID on days 1-3, 8-10, and 15-17, paclitaxel IV over 1 hour on days 2, 9, and 16, bevacizumab IV over 30-90 minutes on days 2 and 16, repeat every 28 days.~vorinostat: Given orally~paclitaxel: Given IV~bevacizumab: Given IV"
1176619|NCT00368875|O1|Outcome|Phase I + Phase II|"Phase I: Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy.~Phase II: Vorinostat was administered orally twice daily at the recommended phase II dose of 300 mg on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose."
1176620|NCT00368875|O1|Outcome|Phase I + Phase II|"Phase I: Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy.~Phase II: Vorinostat was administered orally twice daily at the recommended phase II dose of 300 mg on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose."
1176748|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
1176621|NCT00368875|O1|Outcome|Phase I|"Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy."
1176622|NCT00368875|E1|Reported Event|Phase I + Phase II|"Phase I: Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy.~Phase II: Vorinostat was administered orally twice daily at the recommended phase II dose of 300 mg on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose."
1176623|NCT00368849|B1|Baseline|All Participants|Age, sex, and region of enrollment were available for all 20 participants.
1176624|NCT00368849|P2|Participant Flow|Placebo (4 Weeks) Then Atomoxetine (4 Weeks)|Participants received twice a day matching placebo for four weeks. After a two week washout, they then received 40 milligram twice a day atomoxetine for four weeks.
1176625|NCT00368849|P1|Participant Flow|Atomoxetine (4 Weeks) Then Placebo (4 Weeks)|Participants received 40 milligram twice a day atomoxetine for four weeks. After a two week wash out, they then received twice a day matching placebo for four weeks.
1176626|NCT00368849|O2|Outcome|Placebo|Individuals in this arm received twice a day matching placebo.
1176627|NCT00368849|O1|Outcome|Atomoxetine|Individuals in this arm received 40 milligram twice a day atomoxetine.
1176628|NCT00368849|O2|Outcome|Placebo|Individuals in this arm received twice a day matching placebo.
1176629|NCT00368849|O1|Outcome|Atomoxetine|Individuals in this arm received 40 milligram twice a day atomoxetine.
1176630|NCT00368849|O2|Outcome|Placebo|Individuals in this arm received twice a day matching placebo.
1176631|NCT00368849|O1|Outcome|Atomoxetine|Individuals in this arm received 40 milligram twice a day atomoxetine.
1176632|NCT00368849|O2|Outcome|Placebo|Individuals in this arm received twice a day matching placebo.
1176633|NCT00368849|O1|Outcome|Atomoxetine|Individuals in this arm received 40 milligram twice a day atomoxetine.
1176634|NCT00368849|O2|Outcome|Placebo|Individuals in this arm received twice a day matching placebo.
1176635|NCT00368849|O1|Outcome|Atomoxetine|Individuals in this arm received 40 milligram twice a day atomoxetine
1176636|NCT00368849|E2|Reported Event|Matching Placebo|Individuals in this arm received twice a day matching placebo.
1176637|NCT00368849|E1|Reported Event|Atomoxetine|Individuals in this arm received 40 milligram twice a day atomoxetine.
1176638|NCT00368745|B3|Baseline|Total|Total of all reporting groups
1176639|NCT00368745|B2|Baseline|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
1176640|NCT00368745|B1|Baseline|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
1176641|NCT00368745|P2|Participant Flow|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
1176642|NCT00368745|P1|Participant Flow|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
1176643|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
1176694|NCT00368537|B2|Baseline|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
1176695|NCT00368537|B1|Baseline|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
1176644|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
1176645|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
1176646|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
1176647|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
1176648|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
1176649|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
1176650|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
1176651|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
1176652|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
1176653|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
1176654|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
1176743|NCT00367679|B1|Baseline|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
1176655|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
1176656|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
1176657|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
1176658|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
1176659|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
1176660|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
1176661|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
1176662|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
1176663|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
1176664|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
1176665|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
1176744|NCT00367679|P1|Participant Flow|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
1176851|NCT00368069|O2|Outcome|Placebo|placebo
1176666|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
1176667|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
1176668|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
1176669|NCT00368745|E2|Reported Event|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
1176670|NCT00368745|E1|Reported Event|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
1176671|NCT00368641|B3|Baseline|Total|Total of all reporting groups
1176672|NCT00368641|B2|Baseline|Standard Therapy|Standard therapy for CHF
1176673|NCT00368641|B1|Baseline|Intervention Group|Addition of peritoneal ultrafiltration
1176674|NCT00368641|P2|Participant Flow|Standard Therapy|Standard therapy for CHF
1176675|NCT00368641|P1|Participant Flow|Intervention Group|Addition of peritoneal ultrafiltration
1176676|NCT00368641|O2|Outcome|Standard Therapy|Standard therapy for CHF
1176677|NCT00368641|O1|Outcome|Intervention Group|Addition of peritoneal ultrafiltration
1176678|NCT00368641|E2|Reported Event|Standard Therapy|Standard therapy for CHF
1176679|NCT00368641|E1|Reported Event|Intervention Group|Addition of peritoneal ultrafiltration
1176680|NCT00368550|B3|Baseline|Total|Total of all reporting groups
1176681|NCT00368550|B2|Baseline|Placebo|Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
1176682|NCT00368550|B1|Baseline|Sertraline|Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
1176683|NCT00368550|P2|Participant Flow|Placebo|Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
1176684|NCT00368550|P1|Participant Flow|Sertraline|Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
1176685|NCT00368550|O2|Outcome|Placebo|Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
1176686|NCT00368550|O1|Outcome|Sertraline|Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
1176687|NCT00368550|O2|Outcome|Placebo|Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
1176688|NCT00368550|O1|Outcome|Sertraline|Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
1176689|NCT00368550|O2|Outcome|Placebo|Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
1176690|NCT00368550|O1|Outcome|Sertraline|Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
1176691|NCT00368550|E2|Reported Event|Placebo|Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
1176692|NCT00368550|E1|Reported Event|Sertraline|Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
1176693|NCT00368537|B3|Baseline|Total|Total of all reporting groups
1176852|NCT00368069|O1|Outcome|Keppra®|Keppra® extended release formulation (XR)
1176853|NCT00368069|O2|Outcome|Placebo|placebo
1176696|NCT00368537|P2|Participant Flow|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
1176697|NCT00368537|P1|Participant Flow|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
1176698|NCT00368537|O2|Outcome|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
1176699|NCT00368537|O1|Outcome|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
1176700|NCT00368537|O2|Outcome|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
1176701|NCT00368537|O1|Outcome|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
1176702|NCT00368537|O2|Outcome|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
1176703|NCT00368537|O1|Outcome|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
1176704|NCT00368537|O2|Outcome|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
1176705|NCT00368537|O1|Outcome|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
1176706|NCT00368537|O2|Outcome|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
1176707|NCT00368537|O1|Outcome|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
1176708|NCT00368537|E2|Reported Event|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
1176709|NCT00368537|E1|Reported Event|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
1176710|NCT00368472|B1|Baseline|Perampanel|Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
1176711|NCT00368472|P1|Participant Flow|Perampanel|Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
1176712|NCT00368472|O1|Outcome|Perampanel|Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
1176713|NCT00368472|O1|Outcome|Perampanel|Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
1176714|NCT00368472|O1|Outcome|Perampanel|Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
1176715|NCT00368472|E1|Reported Event|Perampanel|Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
1176716|NCT00368459|B3|Baseline|Total|Total of all reporting groups
1176717|NCT00368459|B2|Baseline|Placebo|identical appearing oral placebo
1176718|NCT00368459|B1|Baseline|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
1176719|NCT00368459|P2|Participant Flow|Placebo|identical appearing oral placebo
1176720|NCT00368459|P1|Participant Flow|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
1176721|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
1176722|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
1176723|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
1176724|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
1176725|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
1176726|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
1176727|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
1176728|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
1176729|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
1176730|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
1176731|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
1176732|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
1176733|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
1176734|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
1176735|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
1176736|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
1176737|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
1176738|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
1176739|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
1176740|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
1176741|NCT00368459|E2|Reported Event|Placebo|identical appearing oral placebo
1176742|NCT00368459|E1|Reported Event|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
1183696|NCT00349908|O2|Outcome|Group 2|Aneurysm Arm
1176749|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
1176750|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
1176751|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
1176752|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
1176753|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
1176754|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
1176755|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
1176756|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
1176757|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
1176758|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
1176759|NCT00367679|E1|Reported Event|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
1176760|NCT00368316|B3|Baseline|Total|Total of all reporting groups
1176761|NCT00368316|B2|Baseline|S. Flexneri 2a Conjugate Vaccine|Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
1176762|NCT00368316|B1|Baseline|S. Sonnei Conjugate Vaccine|Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
1176763|NCT00368316|P2|Participant Flow|S. Flexneri 2a Conjugate Vaccine|Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
1176764|NCT00368316|P1|Participant Flow|S. Sonnei Conjugate Vaccine|Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
1176765|NCT00368316|O2|Outcome|S. Flexneri 2a Conjugate Vaccine|Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
1176766|NCT00368316|O1|Outcome|S. Sonnei Conjugate Vaccine|Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
1176767|NCT00368316|O2|Outcome|S. Flexneri 2a Conjugate Vaccine|Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
1176768|NCT00368316|O1|Outcome|S. Sonnei Conjugate Vaccine|Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
1176769|NCT00368316|O2|Outcome|S. Flexneri 2a Conjugate Vaccine|Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
1176770|NCT00368316|O1|Outcome|S. Sonnei Conjugate Vaccine|Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
1176771|NCT00368316|E2|Reported Event|S. Flexneri 2a Conjugate Vaccine|Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
1176772|NCT00368316|E1|Reported Event|S. Sonnei Conjugate Vaccine|Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
1176773|NCT00368290|B3|Baseline|Total|Total of all reporting groups
1176774|NCT00368290|B2|Baseline|Placebo|"placebo plus CBT~placebo: placebo pills for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
1176775|NCT00368290|B1|Baseline|Modafinil|"modafinil plus CBT~Modafinil: 300mg a day for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
1176776|NCT00368290|P2|Participant Flow|Placebo|"placebo plus CBT~placebo: placebo pills for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
1176777|NCT00368290|P1|Participant Flow|Modafinil|"modafinil plus CBT~Modafinil: 300mg a day for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
1176778|NCT00368290|O2|Outcome|Placebo|"placebo plus CBT~placebo: placebo pills for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
1176779|NCT00368290|O1|Outcome|Modafinil|"modafinil plus CBT~Modafinil: 300mg a day for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
1176780|NCT00368290|O2|Outcome|Placebo|"placebo plus CBT~placebo: placebo pills for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
1176781|NCT00368290|O1|Outcome|Modafinil|"modafinil plus CBT~Modafinil: 300mg a day for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
1176782|NCT00368290|E2|Reported Event|Placebo|"placebo plus CBT~placebo: placebo pills for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
1176783|NCT00368290|E1|Reported Event|Modafinil|"modafinil plus CBT~Modafinil: 300mg a day for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
1176784|NCT00368277|B3|Baseline|Total|Total of all reporting groups
1183697|NCT00349908|O1|Outcome|Group 1|Atherosclerosis
1176785|NCT00368277|B2|Baseline|Ramipril Based Treatment Regimen|Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
1176786|NCT00368277|B1|Baseline|Aliskiren Based Treatment Regimen|Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
1176787|NCT00368277|P2|Participant Flow|Ramipril Based Treatment Regimen|Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
1176788|NCT00368277|P1|Participant Flow|Aliskiren Based Treatment Regimen|Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
1176789|NCT00368277|O2|Outcome|Ramipril Based Treatment Regimen|Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
1176790|NCT00368277|O1|Outcome|Aliskiren Based Treatment Regimen|Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
1176791|NCT00368277|O2|Outcome|Ramipril Based Treatment Regimen|Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
1176792|NCT00368277|O1|Outcome|Aliskiren Based Treatment Regimen|Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
1176793|NCT00368277|O2|Outcome|Ramipril Based Treatment Regimen|Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
1176794|NCT00368277|O1|Outcome|Aliskiren Based Treatment Regimen|Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
1176795|NCT00368277|O2|Outcome|Ramipril Based Treatment Regimen|Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
1176796|NCT00368277|O1|Outcome|Aliskiren Based Treatment Regimen|Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
1176797|NCT00368277|E2|Reported Event|Ramipril|Ramipril based regimen
1176798|NCT00368277|E1|Reported Event|Aliskiren|Aliskiren based regimen
1176799|NCT00368251|B4|Baseline|Total Title|
1176800|NCT00368251|B3|Baseline|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
1176801|NCT00368251|B2|Baseline|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
1176802|NCT00368251|B1|Baseline|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
1176803|NCT00368251|P3|Participant Flow|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
1176804|NCT00368251|P2|Participant Flow|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
1176805|NCT00368251|P1|Participant Flow|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
1176806|NCT00368251|O3|Outcome|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
1176807|NCT00368251|O2|Outcome|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
1176808|NCT00368251|O1|Outcome|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
1176809|NCT00368251|O3|Outcome|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
1176810|NCT00368251|O2|Outcome|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
1176811|NCT00368251|O1|Outcome|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
1176812|NCT00368251|O3|Outcome|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
1176813|NCT00368251|O2|Outcome|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
1176814|NCT00368251|O1|Outcome|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
1176815|NCT00368251|O3|Outcome|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
1176816|NCT00368251|O2|Outcome|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
1176817|NCT00368251|O1|Outcome|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
1176854|NCT00368069|O1|Outcome|Keppra®|Keppra® extended release formulation (XR)
1176818|NCT00368251|O3|Outcome|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
1176819|NCT00368251|O2|Outcome|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
1176820|NCT00368251|O1|Outcome|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
1176821|NCT00368251|E3|Reported Event|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
1176822|NCT00368251|E2|Reported Event|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
1176823|NCT00368251|E1|Reported Event|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
1176824|NCT00368108|B4|Baseline|Total|Total of all reporting groups
1176825|NCT00368108|B3|Baseline|Perampanel 4mg|The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
1176826|NCT00368108|B2|Baseline|Perampanel 2mg|The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
1176827|NCT00368108|B1|Baseline|Placebo|The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
1176828|NCT00368108|P3|Participant Flow|Perampanel 4mg|The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
1176890|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
1176829|NCT00368108|P2|Participant Flow|Perampanel 2mg|The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
1176830|NCT00368108|P1|Participant Flow|Placebo|The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
1176831|NCT00368108|O3|Outcome|Perampanel 4mg|The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
1176832|NCT00368108|O2|Outcome|Perampanel 2mg|The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
1176833|NCT00368108|O1|Outcome|Placebo|The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
1176834|NCT00368108|O3|Outcome|Perampanel 4mg|The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
1176835|NCT00368108|O2|Outcome|Perampanel 2mg|The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
1176836|NCT00368108|O1|Outcome|Placebo|The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
1176837|NCT00368108|O3|Outcome|Perampanel 4mg|The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
1176838|NCT00368108|O2|Outcome|Perampanel 2mg|The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
1176839|NCT00368108|O1|Outcome|Placebo|The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
1176840|NCT00368108|O3|Outcome|Perampanel 4mg|The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
1176841|NCT00368108|O2|Outcome|Perampanel 2mg|The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
1176842|NCT00368108|O1|Outcome|Placebo|The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
1176843|NCT00368108|E3|Reported Event|Perampanel 4mg|The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
1176844|NCT00368108|E2|Reported Event|Perampanel 2mg|The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
1176845|NCT00368108|E1|Reported Event|Placebo|The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
1176846|NCT00368069|B3|Baseline|Total|Total of all reporting groups
1176847|NCT00368069|B2|Baseline|Placebo|placebo
1176848|NCT00368069|B1|Baseline|Keppra®|Keppra® extended release formulation (XR)
1176849|NCT00368069|P2|Participant Flow|Placebo|placebo
1176850|NCT00368069|P1|Participant Flow|Keppra®|Keppra® extended release formulation (XR)
1176867|NCT00367991|B1|Baseline|rHuEPO|recombinant human erythropoietin 200 U/kg IV daily for 3 days
1176868|NCT00367991|P2|Participant Flow|Placebo|Normal saline volume to match active treatment IV daily for 3 days
1176869|NCT00367991|P1|Participant Flow|rHuEPO|recombinant human erythropoietin 200 U/kg IV daily for 3 days
1176870|NCT00367991|O2|Outcome|rHuEPO|recombinant human erythropoietin
1176871|NCT00367991|O1|Outcome|Placebo|normal saline
1176872|NCT00367991|E2|Reported Event|Placebo|Normal saline volume to match active treatment IV daily for 3 days
1176873|NCT00367991|E1|Reported Event|rHuEPO|recombinant human erythropoietin 200 U/kg IV daily for 3 days
1176874|NCT00367835|B3|Baseline|Total|Total of all reporting groups
1176875|NCT00367835|B2|Baseline|Placebo|
1176876|NCT00367835|B1|Baseline|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
1176877|NCT00367835|P2|Participant Flow|Placebo|
1176878|NCT00367835|P1|Participant Flow|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
1176879|NCT00367835|O2|Outcome|Placebo|
1176880|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
1176881|NCT00367835|O2|Outcome|Placebo|
1176882|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
1176883|NCT00367835|O2|Outcome|Placebo|
1176884|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
1176885|NCT00367835|O2|Outcome|Placebo|
1176886|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
1176887|NCT00367835|O2|Outcome|Placebo|
1176888|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
1176889|NCT00367835|O2|Outcome|Placebo|
1176892|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
1176893|NCT00367835|O2|Outcome|Placebo|
1176894|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
1176895|NCT00367835|O2|Outcome|Placebo|
1176896|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
1176897|NCT00367835|O2|Outcome|Placebo|
1176898|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
1176899|NCT00367835|O2|Outcome|Placebo|
1176900|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
1176901|NCT00367835|E2|Reported Event|Placebo|
1176902|NCT00367835|E1|Reported Event|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
1176903|NCT00367770|B1|Baseline|Overall Study Arm|
1176904|NCT00367770|P1|Participant Flow|Tracleer|The starting dose for all patients will be 62.5 mg b.i.d. At the Week 4 visit, patients who were started on 62.5 mg b.i.d. will be uptitrated to 125 mg b.i.d. if the 62.5 mg b.i.d. dose was well-tolerated.
1176905|NCT00367770|O1|Outcome|Overall Study Arm|
1176906|NCT00367770|O1|Outcome|Overall Study Arm|
1176907|NCT00367770|O1|Outcome|Overall Study Arm|
1176908|NCT00367770|E1|Reported Event|Tracleer|The starting dose for all patients will be 62.5 mg b.i.d. At the Week 4 visit, patients who were started on 62.5 mg b.i.d. will be uptitrated to 125 mg b.i.d. if the 62.5 mg b.i.d. dose was well-tolerated.
1176909|NCT00367744|B3|Baseline|Total|Total of all reporting groups
1176910|NCT00367744|B2|Baseline|Placebo|Placebo arm
1176911|NCT00367744|B1|Baseline|Rosiglitazone|Rosiglitazone 4mg daily for 4 weeks then the dose increased to 4mg twice daily for the remainder of the study (44 weeks)
1176912|NCT00367744|P2|Participant Flow|Placebo|Placebo arm for the whole duration of the study
1176913|NCT00367744|P1|Participant Flow|Rosiglitazone|Rosiglitazone 4 mg daily for 4 weeks then the dose was increased to 4mg twice daily for the remainder of the study (44 weeks)
1176914|NCT00367744|O2|Outcome|Placebo|Placebo arm
1176915|NCT00367744|O1|Outcome|Rosiglitazone|Rosiglitazone 4mg daily for 4 weeks then 4mg BID for 44 weeks
1176916|NCT00367744|O2|Outcome|Placebo|Placebo arm
1176917|NCT00367744|O1|Outcome|Rosiglitazone|Rosiglitazone 4mg daily for 4 weeks then BID for 44 weeks
1176918|NCT00367744|E2|Reported Event|Placebo|Placebo arm
1176919|NCT00367744|E1|Reported Event|Rosiglitazone|Rosiglitazone 4mg daily for 4 weeks then 4mg BID for 44 weeks
1176920|NCT00367640|B5|Baseline|Total|Total of all reporting groups
1176921|NCT00367640|B4|Baseline|Placebo|Placebo tablet
1176922|NCT00367640|B3|Baseline|500 IR|500 IR grass pollen allergen extract tablet
1176923|NCT00367640|B2|Baseline|300 IR|300 IR grass pollen allergen extract tablet
1176924|NCT00367640|B1|Baseline|100 IR|100 IR grass pollen allergen extract tablet
1176925|NCT00367640|P4|Participant Flow|Placebo|Placebo tablet
1176926|NCT00367640|P3|Participant Flow|500 IR|500 IR grass pollen allergen extract tablet
1176927|NCT00367640|P2|Participant Flow|300 IR|300 IR grass pollen allergen extract tablet
1176928|NCT00367640|P1|Participant Flow|100 IR|100 IR grass pollen allergen extract tablet
1176929|NCT00367640|O4|Outcome|Placebo|Placebo tablet
1176930|NCT00367640|O3|Outcome|500 IR|500 IR grass pollen allergen extract tablet
1176931|NCT00367640|O2|Outcome|300 IR|300 IR grass pollen allergen extract tablet
1176932|NCT00367640|O1|Outcome|100 IR|100 IR grass pollen allergen extract tablet
1176933|NCT00367640|E4|Reported Event|Placebo|Placebo tablet
1176934|NCT00367640|E3|Reported Event|100 IR|100 IR grass pollen allergen extract tablet
1176935|NCT00367640|E2|Reported Event|300 IR|300 IR grass pollen allergen extract tablet
1176936|NCT00367640|E1|Reported Event|500 IR|500 IR grass pollen allergen extract tablet
1176937|NCT00367601|B1|Baseline|Single Arm Assignment|"Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.~Erlotinib: Erlotinib 150 mg qd days 1-21~Bevacizumab: Bevacizumab 15 mg/kg IV, day 1"
1176938|NCT00367601|P1|Participant Flow|Single Arm Assignment|"Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.~Erlotinib: Erlotinib 150 mg qd days 1-21~Bevacizumab: Bevacizumab 15 mg/kg IV, day 1"
1176939|NCT00367601|O1|Outcome|Single Arm Assignment|"Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.~Erlotinib: Erlotinib 150 mg qd days 1-21~Bevacizumab: Bevacizumab 15 mg/kg IV, day 1"
1176940|NCT00367601|O1|Outcome|Single Arm Assignment|"Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.~Erlotinib: Erlotinib 150 mg qd days 1-21~Bevacizumab: Bevacizumab 15 mg/kg IV, day 1"
1176941|NCT00367601|O1|Outcome|Single Arm|Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.
1176942|NCT00367601|E1|Reported Event|Single Arm Assignment|"Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.~Erlotinib: Erlotinib 150 mg qd days 1-21~Bevacizumab: Bevacizumab 15 mg/kg IV, day 1"
1176943|NCT00367484|B1|Baseline|Rebif® (Clone 484-39)|subcutaneously administered Rebif® 44mcg three times per week
1176944|NCT00367484|P1|Participant Flow|Rebif® (Clone 484-39)|subcutaneously administered Rebif® 44mcg three times per week
1176945|NCT00367484|O1|Outcome|Rebif® (Clone 484-39)|subcutaneously administered Rebif® 44mcg three times per week
1176946|NCT00367484|E1|Reported Event|Rebif® (Clone 484-39)|subcutaneously administered Rebif® 44mcg three times per week
1176947|NCT00367432|B1|Baseline|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
1176948|NCT00367432|P2|Participant Flow|Levetiracetam N01020 [NCT00160615]|N01020 [NCT00160615] was an open-label follow-up study to evaluate safety and efficacy of Levetiracetam.
1176949|NCT00367432|P1|Participant Flow|Levetiracetam N01221 [NCT00280696]|N01221 [NCT00280696] was a double-blind, randomized, multicenter, placebo controlled 5 parallel groups, confirmatory trial to evaluate the efficacy and safety of Levetiracetam.
1176950|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
1176951|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
1176952|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
1176953|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
1176954|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
1176955|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
1176956|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
1176957|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
1176958|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
1176959|NCT00367432|E1|Reported Event|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
1176960|NCT00367380|B4|Baseline|Total|Total of all reporting groups
1176961|NCT00367380|B3|Baseline|Group 3|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 418JAL~418JAL: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 418JAL"
1176962|NCT00367380|B2|Baseline|Group 2|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 414WRR~414WRR: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 414WRR"
1176963|NCT00367380|B1|Baseline|Group 1|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 413ABM~413ABM: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 413ABM"
1176964|NCT00367380|P3|Participant Flow|Group 3|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 418JAL~418JAL: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 418JAL"
1176965|NCT00367380|P2|Participant Flow|Group 2|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 414WRR~414WRR: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 414WRR"
1176966|NCT00367380|P1|Participant Flow|Group 1|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 413ABM~413ABM: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 413ABM"
1176967|NCT00367380|O3|Outcome|Group 3|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 418JAL~418JAL: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 418JAL"
1177014|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
1183698|NCT00349908|O2|Outcome|Group 2|Aneurysm Arm
1176968|NCT00367380|O2|Outcome|Group 2|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 414WRR~414WRR: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 414WRR"
1176969|NCT00367380|O1|Outcome|Group 1|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 413ABM~413ABM: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 413ABM"
1176970|NCT00367380|E3|Reported Event|Group 3|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 418JAL~418JAL: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 418JAL"
1176971|NCT00367380|E2|Reported Event|Group 2|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 414WRR~414WRR: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 414WRR"
1176972|NCT00367380|E1|Reported Event|Group 1|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 413ABM~413ABM: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 413ABM"
1176973|NCT00367341|B3|Baseline|Total|Total of all reporting groups
1176974|NCT00367341|B2|Baseline|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
1176975|NCT00367341|B1|Baseline|Escitalopram|escitalopram : Participants will receive treatment with escitalopram for 12 weeks.
1176976|NCT00367341|P2|Participant Flow|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
1176977|NCT00367341|P1|Participant Flow|Escitalopram|escitalopram : Participants will receive treatment with escitalopram for 12 weeks.
1176978|NCT00367341|O2|Outcome|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
1176979|NCT00367341|O1|Outcome|Escitalopram|escitalopram : Participants will receive treatment with escitalopram for 12 weeks.
1176980|NCT00367341|O2|Outcome|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
1176981|NCT00367341|O1|Outcome|Escitalopram|escitalopram : Participants will receive treatment with escitalopram for 12 weeks.
1176982|NCT00367341|E2|Reported Event|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
1176983|NCT00367341|E1|Reported Event|Escitalopram|escitalopram : Participants will receive treatment with escitalopram for 12 weeks.
1176984|NCT00367237|B3|Baseline|Total|Total of all reporting groups
1176985|NCT00367237|B2|Baseline|Methotrexate (MTX)|Oral methotrexate (MTX) 15 mg/week
1176986|NCT00367237|B1|Baseline|Infliximab + Methotrexate (IFX + MTX)|Remicade (infliximab [IFX]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
1176987|NCT00367237|P2|Participant Flow|Methotrexate (MTX)|Oral methotrexate (MTX) 15 mg/week
1176988|NCT00367237|P1|Participant Flow|Infliximab + Methotrexate (IFX + MTX)|Remicade (infliximab [IFX]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
1176989|NCT00367237|O2|Outcome|Methotrexate (MTX)|Oral methotrexate (MTX) 15 mg/week
1176990|NCT00367237|O1|Outcome|Infliximab + Methotrexate (IFX + MTX)|Remicade (infliximab [IFX]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
1176991|NCT00367237|E2|Reported Event|Methotrexate (MTX)|Oral methotrexate (MTX) 15 mg/week
1176992|NCT00367237|E1|Reported Event|Infliximab + Methotrexate (IFX + MTX)|Remicade (infliximab [IFX]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
1176993|NCT00367133|B4|Baseline|Total|Total of all reporting groups
1176994|NCT00367133|B3|Baseline|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
1176995|NCT00367133|B2|Baseline|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
1176996|NCT00367133|B1|Baseline|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
1176997|NCT00367133|P3|Participant Flow|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
1176998|NCT00367133|P2|Participant Flow|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
1176999|NCT00367133|P1|Participant Flow|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
1177000|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
1177001|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
1177002|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
1177003|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
1177004|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
1177005|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
1177006|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
1177007|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
1177008|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
1177009|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
1177010|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
1177011|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
1177012|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
1177013|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
1177288|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
1177015|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
1177016|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
1177017|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
1177018|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
1177019|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
1177020|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
1177021|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
1177022|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
1177023|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
1177024|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
1177025|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
1177026|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
1177027|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
1177028|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
1177029|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
1177030|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
1177031|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
1177032|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
1177033|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
1177034|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
1177035|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
1177036|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
1177037|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
1177038|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
1177039|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
1177040|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
1177041|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
1177042|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
1177043|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
1177044|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
1177045|NCT00367133|E3|Reported Event|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
1177046|NCT00367133|E2|Reported Event|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
1177047|NCT00367133|E1|Reported Event|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
1177048|NCT00367055|B3|Baseline|Total|Total of all reporting groups
1177049|NCT00367055|B2|Baseline|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
1177050|NCT00367055|B1|Baseline|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
1177051|NCT00367055|P2|Participant Flow|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
1177052|NCT00367055|P1|Participant Flow|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
1177053|NCT00367055|O2|Outcome|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
1177054|NCT00367055|O1|Outcome|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
1177055|NCT00367055|O2|Outcome|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
1177056|NCT00367055|O1|Outcome|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
1177057|NCT00367055|O2|Outcome|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
1177058|NCT00367055|O1|Outcome|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
1177289|NCT00365859|O4|Outcome|Total|
1177290|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
1177059|NCT00367055|O2|Outcome|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
1177060|NCT00367055|O1|Outcome|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
1177061|NCT00367055|O2|Outcome|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
1177062|NCT00367055|O1|Outcome|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
1177063|NCT00367055|E2|Reported Event|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
1177064|NCT00367055|E1|Reported Event|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
1177065|NCT00366899|B3|Baseline|Total|Total of all reporting groups
1177066|NCT00366899|B2|Baseline|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at 3 and 5 months (infant series), and 11 months of age (toddler dose).
1177067|NCT00366899|B1|Baseline|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at 3 and 5 months (infant series), and 11 months of age (toddler dose).
1177103|NCT00366899|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
1177863|NCT00364858|O1|Outcome|Q2 Cerezyme|Patients receiving Cerezyme one infusion every 2 weeks (Q2).
1177068|NCT00366899|P2|Participant Flow|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at 3 and 5 months (infant series), and 11 months of age (toddler dose).
1177069|NCT00366899|P1|Participant Flow|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at 3 and 5 months (infant series), and 11 months of age (toddler dose).
1177070|NCT00366899|O2|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 12 months of age (toddler dose).
1177071|NCT00366899|O1|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 12 months of age (toddler dose).
1177072|NCT00366899|O2|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
1177073|NCT00366899|O1|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
1177074|NCT00366899|O2|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
1177075|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
1177076|NCT00366899|O2|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
1177077|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
1177078|NCT00366899|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
1177079|NCT00366899|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
1177080|NCT00366899|O2|Outcome|7vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
1177081|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
1177082|NCT00366899|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
1177083|NCT00366899|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
1177084|NCT00366899|O2|Outcome|7vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
1177085|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
1177086|NCT00366899|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
1177087|NCT00366899|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
1177088|NCT00366899|O2|Outcome|7vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
1177089|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
1177090|NCT00366899|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
1177091|NCT00366899|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
1177291|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
1177092|NCT00366899|O2|Outcome|7vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
1177093|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
1177094|NCT00366899|O2|Outcome|13vPnC After Toddler Dose|Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
1177095|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
1177096|NCT00366899|O2|Outcome|13vPnC After Toddler Dose|Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
1177097|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
1177098|NCT00366899|O4|Outcome|7vPnC After Toddler Dose|Subjects received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
1177099|NCT00366899|O3|Outcome|13vPnC After Toddler Dose|Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
1177100|NCT00366899|O2|Outcome|7vPnC After 2-Dose Infant Series|Subjects received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
1177101|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
1177102|NCT00366899|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
1177316|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
1177104|NCT00366899|O2|Outcome|7vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
1177105|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
1177106|NCT00366899|O6|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age.
1177107|NCT00366899|O5|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age.
1177108|NCT00366899|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 5 months of age.
1177109|NCT00366899|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 5 months of age.
1177110|NCT00366899|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 months of age.
1177111|NCT00366899|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 months of age.
1177112|NCT00366899|O6|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age.
1177113|NCT00366899|O5|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age.
1177114|NCT00366899|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 5 months of age.
1177115|NCT00366899|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 5 months of age.
1177116|NCT00366899|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 months of age.
1177117|NCT00366899|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 months of age.
1177118|NCT00366899|E8|Reported Event|7vPnC 6-Month Follow-up|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months (infant series) and 11 months of age (toddler dose). Adverse events were collected for approximately six months after last visit.
1177119|NCT00366899|E7|Reported Event|13vPnC 6-Month Follow-up|Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months (infant series) and 11 months of age (toddler dose). Adverse events were collected for approximately six months after last visit.
1177120|NCT00366899|E6|Reported Event|7vPnC Toddler Series|Participants received one single 0.5mL dose of 7vPnC at 11 months of age. Adverse events were collected for approximately one month after toddler dose.
1177121|NCT00366899|E5|Reported Event|13vPnC Toddler Series|Participants received one single 0.5mL dose of 13vPnC at 11 months of age. Adverse events were collected for approximately one month after toddler dose.
1177122|NCT00366899|E4|Reported Event|7vPnC Post-Infant Series|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months. Adverse events were collected from approximately one month after dose 2 to toddler dose.
1177123|NCT00366899|E3|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months. Adverse events were collected from approximately one month after dose 2 to toddler dose.
1177124|NCT00366899|E2|Reported Event|7vPnC Infant Series|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months. Adverse events were collected from dose 1 to approximately one month after dose 2.
1177125|NCT00366899|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months. Adverse events were collected from dose 1 to approximately one month after dose 2.
1177126|NCT00366678|B3|Baseline|Total|Total of all reporting groups
1177127|NCT00366678|B2|Baseline|7vPnC/7vPnC Vaccine|Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
1183699|NCT00349908|O1|Outcome|Group 1|Atherosclerosis Arm
1177128|NCT00366678|B1|Baseline|13vPnC/13vPnC Vaccine|Participants received one single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
1177129|NCT00366678|P3|Participant Flow|7vPnC/13vPnC Vaccine|Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC)coadministered with Pentavac at 12 months of age (toddler dose).
1177130|NCT00366678|P2|Participant Flow|7vPnC/7vPnC Vaccine|Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
1177131|NCT00366678|P1|Participant Flow|13vPnC/13vPnC Vaccine|Participants received one single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
1177132|NCT00366678|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series).
1177133|NCT00366678|O9|Outcome|7vPnC/13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose).
1177317|NCT00365859|E3|Reported Event|Roll Over Placebo|
1177318|NCT00365859|E2|Reported Event|Roll Over Aripiprazole|
1177134|NCT00366678|O8|Outcome|7vPnC/7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
1177135|NCT00366678|O7|Outcome|13vPnC/13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
1177136|NCT00366678|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 4 months of age (infant series).
1177137|NCT00366678|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 4 months of age (infant series).
1177138|NCT00366678|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 3 months of age (infant series).
1177139|NCT00366678|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 3 months of age (infant series).
1177140|NCT00366678|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2 months of age (infant series).
1177141|NCT00366678|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2 months of age (infant series).
1177142|NCT00366678|O9|Outcome|7vPnC/13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
1177143|NCT00366678|O8|Outcome|7vPnC/7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
1177144|NCT00366678|O7|Outcome|13vPnC/13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
1177145|NCT00366678|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 4 months of age (infant series).
1177146|NCT00366678|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 4 months of age (infant series).
1177147|NCT00366678|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 3 months of age (infant series).
1177148|NCT00366678|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 3 months of age (infant series).
1177149|NCT00366678|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2 months of age (infant series).
1177150|NCT00366678|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2 months of age (infant series).
1177151|NCT00366678|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series).
1177152|NCT00366678|O4|Outcome|7vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
1177153|NCT00366678|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
1177154|NCT00366678|O2|Outcome|7vPnC After the Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
1177155|NCT00366678|O1|Outcome|13vPnC After the Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
1177156|NCT00366678|O4|Outcome|7vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
1177157|NCT00366678|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
1185048|NCT00344032|B3|Baseline|Total|Total of all reporting groups
1177158|NCT00366678|O2|Outcome|7vPnC After the Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
1177159|NCT00366678|O1|Outcome|13vPnC After the Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
1177160|NCT00366678|O4|Outcome|7vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
1177161|NCT00366678|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
1177162|NCT00366678|O2|Outcome|7vPnC After the Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
1177163|NCT00366678|O1|Outcome|13vPnC After the Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
1177164|NCT00366678|O4|Outcome|7vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
1177165|NCT00366678|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
1177166|NCT00366678|O2|Outcome|7vPnC After the Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series).
1177167|NCT00366678|O1|Outcome|13vPnC After the Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series).
1177168|NCT00366678|O2|Outcome|7vPnC/13vPnC After Toddler Dose|Subjects received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months. One single 0.5 mL dose of 13vPnC was coadministered with Pentavac at 12 months of age.
1177169|NCT00366678|O1|Outcome|13vPnC/13vPnC After Toddler Dose|Subjects received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 2, 3, 4, and 12 months of age.
1177170|NCT00366678|O2|Outcome|7vPnC/13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose).
1177171|NCT00366678|O1|Outcome|13vPnC/13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
1177172|NCT00366678|O6|Outcome|7vPnC/13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose), assessment made at 13 months of age.
1177173|NCT00366678|O5|Outcome|7vPnC/13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose).
1177174|NCT00366678|O4|Outcome|7vPnC/7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose), assessment made at 13 months of age.
1177175|NCT00366678|O3|Outcome|7vPnC/7vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
1177176|NCT00366678|O2|Outcome|13vPnC/13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose), assessment made at 13 months of age.
1177177|NCT00366678|O1|Outcome|13vPnC/13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
1177178|NCT00366678|O3|Outcome|7vPnC Infant Series / 13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months. One single 0.5 mL dose of 13vPnC was coadministered with Pentavac at 12 months of age.
1177179|NCT00366678|O2|Outcome|7vPnC Infant Series / 7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
1177180|NCT00366678|O1|Outcome|13vPnC Infant Series / 13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
1177181|NCT00366678|O4|Outcome|7vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
1177182|NCT00366678|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
1177183|NCT00366678|O2|Outcome|7vPnC After the Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
1177184|NCT00366678|O1|Outcome|13vPnC After the Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
1177185|NCT00366678|E10|Reported Event|7vPnC / 13vPnC 6-Month Follow-up|Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series) and at 12 months of age (toddler). Adverse events were collected for approximately six months after last visit.
1177292|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
1177186|NCT00366678|E9|Reported Event|7vPnC / 7vPnC 6-Month Follow-up|Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler). Adverse events were collected for approximately six months after last visit.
1177187|NCT00366678|E8|Reported Event|13vPnC / 13vPnC 6-Month Follow-up|Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler). Adverse events were collected for approximately six months after last visit.
1177188|NCT00366678|E7|Reported Event|7vPnC/ 13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose). Adverse events were collected for approximately one month after toddler dose.
1177189|NCT00366678|E6|Reported Event|7vPnC/7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose). Adverse events were collected for approximately one month after toddler dose.
1177190|NCT00366678|E5|Reported Event|13vPnC/13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose). Adverse events were collected for approximately one month after toddler dose.
1177191|NCT00366678|E4|Reported Event|7vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from approximately one month after dose 3 to toddler dose.
1177192|NCT00366678|E3|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from approximately one month after dose 3 to toddler dose.
1177319|NCT00365859|E1|Reported Event|De Novo|
1177193|NCT00366678|E2|Reported Event|7vPnC Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from dose 1 to approximately one month after dose 3.
1177194|NCT00366678|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from dose 1 to approximately one month after dose 3.
1177195|NCT00366626|B3|Baseline|Total|Total of all reporting groups
1177196|NCT00366626|B2|Baseline|Placebo|
1177197|NCT00366626|B1|Baseline|Naltrexone|
1177198|NCT00366626|P2|Participant Flow|Placebo|
1177199|NCT00366626|P1|Participant Flow|Naltrexone|
1177200|NCT00366626|O4|Outcome|Placebo (asp40)|Subjects with asp40 OPRM1 SNP who got Placebo during he study
1177201|NCT00366626|O3|Outcome|Placebo (asn40asn )|Subjects with asn40asn OPRM1 SNP who got Placebo during he study
1177202|NCT00366626|O2|Outcome|Naltrexone (asp40)|Subjects with asp40 OPRM1 SNP who got Naltrexone during he study
1177203|NCT00366626|O1|Outcome|Naltrexone (asn40asn)|Subjects with asn40asn OPRM1 SNP who got Naltrexone during he study
1177204|NCT00366626|O4|Outcome|Placebo (asp40)|Subjects with asp40 OPRM1 SNP who got Placebo during he study
1177205|NCT00366626|O3|Outcome|Placebo (asn40asn )|Subjects with asn40asn OPRM1 SNP who got Placebo during he study
1177206|NCT00366626|O2|Outcome|Naltrexone (asp40)|Subjects with asp40 OPRM1 SNP who got Naltrexone during he study
1177207|NCT00366626|O1|Outcome|Naltrexone (asn40asn)|Subjects with asn40asn OPRM1 SNP who got Naltrexone during he study
1177208|NCT00366626|E2|Reported Event|Placebo|
1177209|NCT00366626|E1|Reported Event|Naltrexone|
1177210|NCT00365872|B4|Baseline|Total|Total of all reporting groups
1177211|NCT00365872|B3|Baseline|COHORT 3: EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday).~Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
1177212|NCT00365872|B2|Baseline|COHORT 2: EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday).~Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
1177213|NCT00365872|B1|Baseline|COHORT 1: EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday).~Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
1177293|NCT00365859|O4|Outcome|Total|
1177294|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
1177295|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
1177296|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
1177297|NCT00365859|O4|Outcome|Total|
1177298|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
1177299|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
1177214|NCT00365872|P3|Participant Flow|COHORT 3: EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday). Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
1177215|NCT00365872|P2|Participant Flow|COHORT 2: EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday). Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
1177320|NCT00365846|B1|Baseline|Group 1|Campath 1H induction w/ Sirolimus immunosuppression
1177321|NCT00365846|P1|Participant Flow|Group 1|Campath 1H induction w/ Sirolimus immunosuppression
1177322|NCT00365846|O1|Outcome|Group 1|Campath 1H induction w/ Sirolimus immunosuppression
1177323|NCT00365846|O1|Outcome|Group 1Campath 1H Induction w/ Sirolimus Immunosuppression|Campath 1H induction w/ Sirolimus immunosuppression
1177216|NCT00365872|P1|Participant Flow|COHORT 1: EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday). Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
1177217|NCT00365872|O3|Outcome|Single Arm - Cohort 3|DC injection # 4 given 72 hours prior to surgery
1177218|NCT00365872|O2|Outcome|Single Arm - Cohort 2|DC injection # 4 given 48 hours prior to surgery
1177219|NCT00365872|O1|Outcome|Single Arm - Cohort 1|DC injection # 4 given 24 hours prior to surgery
1177220|NCT00365872|O1|Outcome|EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday).~Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
1177221|NCT00365872|O1|Outcome|EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday).~Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
1177222|NCT00365872|O1|Outcome|EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday).~Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
1177223|NCT00365872|O1|Outcome|EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday).~Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
1177224|NCT00365872|E1|Reported Event|EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday).~Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
1177225|NCT00365859|B4|Baseline|Total|Total of all reporting groups
1177226|NCT00365859|B3|Baseline|Rollover Aripiprazole|As previously described in Participant Flow
1177227|NCT00365859|B2|Baseline|Rollover Placebo|As previously described in Participant Flow
1177228|NCT00365859|B1|Baseline|De Novo|As previously described in Participant Flow
1177229|NCT00365859|P4|Participant Flow|Total|
1185379|NCT00342563|O2|Outcome|Placebo|Placebo: Placebo
1177230|NCT00365859|P3|Participant Flow|Rollover Aripiprazole|Participants who completed participation in protocol CN138-178 [NCT00332241] or CN138-179 [NCT00337571] on aripiprazole treatment and continued to meet all of the inclusion criteria and none of the exclusion criteria. Assigned in this study to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose.
1177231|NCT00365859|P2|Participant Flow|Rollover Placebo|Participants who completed participation in protocol (CN138-178 [NCT00332241] or CN138-179 [NCT00337571]) on placebo treatment and continued to meet all of the inclusion criteria and none of the exclusion criteria. Assigned in this study to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose.
1187644|NCT00330460|O2|Outcome|Denosumab 60 mg Q6M|
1177232|NCT00365859|P1|Participant Flow|De Novo|De novo participants (those who did not participate in protocol (CN138-178 [NCT00332241] or CN138-179 [NCT00337571]) assigned to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose.
1177233|NCT00365859|O4|Outcome|Total|
1177234|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
1177235|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
1177236|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
1177237|NCT00365859|O4|Outcome|Total|
1177238|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
1177239|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
1177240|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
1177241|NCT00365859|O4|Outcome|Total|
1177242|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
1177243|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
1177244|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
1177245|NCT00365859|O4|Outcome|Total|
1177246|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
1177247|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
1177248|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
1177249|NCT00365859|O4|Outcome|Total|
1177250|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
1177251|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
1177252|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
1177253|NCT00365859|O4|Outcome|Total|
1177254|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
1177255|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
1177256|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
1177257|NCT00365859|O4|Outcome|Total|
1177258|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
1177259|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
1177260|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
1177261|NCT00365859|O4|Outcome|Total|
1177262|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
1177263|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
1177264|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
1177265|NCT00365859|O4|Outcome|Total|
1177266|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
1177267|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
1177268|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
1177269|NCT00365859|O4|Outcome|Total|
1177270|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
1177271|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
1177272|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
1177273|NCT00365859|O4|Outcome|Total|
1177274|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
1177275|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
1177276|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
1177277|NCT00365859|O4|Outcome|Total|
1177278|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
1177279|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
1177280|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
1177281|NCT00365859|O4|Outcome|Total|
1177282|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
1177283|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
1177284|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
1177285|NCT00365859|O4|Outcome|Total|
1177286|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
1177287|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
1177300|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
1177301|NCT00365859|O4|Outcome|Total|
1177302|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
1177303|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
1177304|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
1177305|NCT00365859|O4|Outcome|Total|
1177306|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
1177307|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
1177308|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
1177309|NCT00365859|O4|Outcome|Total|
1177310|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
1177311|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
1177312|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
1177313|NCT00365859|O4|Outcome|Total|
1177314|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
1177315|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
1177324|NCT00365846|O1|Outcome|Campath 1H Induction w/ Sirolimus Immunosuppression|Campath 1H induction on Day -1 and 0 of renal transplant followed w/ Sirolimus maintenance immunosuppression
1177325|NCT00365846|O1|Outcome|Group 1|Campath 1H induction w/ Sirolimus immunosuppression
1177326|NCT00365846|O1|Outcome|Group 1|Campath 1H induction w/ Sirolimus immunosuppression
1177327|NCT00365846|O1|Outcome|Group 1|Campath 1H induction w/ Sirolimus immunosuppression
1177328|NCT00365846|E1|Reported Event|Group 1|Campath 1H induction w/ Sirolimus immunosuppression
1177329|NCT00365768|B3|Baseline|Total|Total of all reporting groups
1177330|NCT00365768|B2|Baseline|Arm II: Placebo|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.~Placebo: Administered orally twice daily for 21 days"
1177331|NCT00365768|B1|Baseline|Arm I: Glutamine|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.~Glutamine: Administered orally twice daily for 21 days"
1177332|NCT00365768|P2|Participant Flow|Arm II: Placebo|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.~Placebo: Administered orally twice daily for 21 days"
1177333|NCT00365768|P1|Participant Flow|Arm I: Glutamine|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.~Glutamine: Administered orally twice daily for 21 days"
1177334|NCT00365768|O2|Outcome|Arm II: Placebo|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.~Placebo: Administered orally twice daily for 21 days"
1177335|NCT00365768|O1|Outcome|Arm I: Glutamine|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.~Glutamine: Administered orally twice daily for 21 days"
1177336|NCT00365768|O2|Outcome|Arm II: Placebo|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.~Placebo: Administered orally twice daily for 21 days"
1177337|NCT00365768|O1|Outcome|Arm I: Glutamine|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.~Glutamine: Administered orally twice daily for 21 days"
1177338|NCT00365768|E2|Reported Event|Arm II|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.~Placebo: Administered orally twice daily for 21 days"
1177339|NCT00365768|E1|Reported Event|Arm I: Glutamine|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.~Glutamine: Administered orally twice daily for 21 days"
1177340|NCT00365716|B6|Baseline|Total|Total of all reporting groups
1177341|NCT00365716|B5|Baseline|Placebo (mcg) (Aluminum Adjuvant) 450|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
1177342|NCT00365716|B4|Baseline|Placebo (mcg) (Aluminum Adjuvant) 225|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
1177343|NCT00365716|B3|Baseline|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
1177396|NCT00366548|E7|Reported Event|13vPnC + P80 6-Month Follow-up|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
1177428|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
1177344|NCT00365716|B2|Baseline|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
1177345|NCT00365716|B1|Baseline|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
1177346|NCT00365716|P7|Participant Flow|Extension 2|This group includes 17 subjects from the United States, who received placebo during the base study and received 3 doses of qHPV vaccine during the Extension, or received less than 3 doses of the qHPV Vaccine during the base study and completed the dose regimen during the Extension.
1177347|NCT00365716|P6|Participant Flow|Extension 1|This group includes 241 international subjects, who either: (1) received placebo during the base study and continued in the Extension to receive a dose of GARDASIL (20/40/40/20 mcg formulation of qHPV vaccine) at Month 60 (plus 2 and 3 at Months 62 and 66, respectively, (2) received 3 doses of GARDASIL during the Base study and continued into the Extension to receive a fourth dose of GARDASIL at Month 60 for the purposes of investigating whether a fourth dose of vaccine (administered ~4.5 years following completion of a 3-dose primary regimen) induces HPV 6, 11, 16, and 18 antibody responses that characterize immune therapy.
1177864|NCT00364858|O2|Outcome|Q4 Cerezyme|Patients receiving Cerezyme one infusion every 4 weeks(Q4).
1177865|NCT00364858|O1|Outcome|Q2 Cerezyme|Patients receiving Cerezyme one infusion every 2 weeks (Q2).
1177348|NCT00365716|P5|Participant Flow|Placebo (mcg) (Aluminum Adjuvant) 450|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
1177349|NCT00365716|P4|Participant Flow|Placebo (mcg) (Aluminum Adjuvant) 225|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
1177350|NCT00365716|P3|Participant Flow|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
1177351|NCT00365716|P2|Participant Flow|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
1177352|NCT00365716|P1|Participant Flow|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
1177353|NCT00365716|O2|Outcome|Placebo (mcg) (Aluminum Adjuvant) 225 or 450 Combined|For the purposes of this outcome measure, the placebo groups (225 mcg and 450 mcg) were combined.
1177354|NCT00365716|O1|Outcome|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
1177355|NCT00365716|O5|Outcome|Placebo (mcg) (Aluminum Adjuvant) 450|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
1177356|NCT00365716|O4|Outcome|Placebo (mcg) (Aluminum Adjuvant) 225|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
1177357|NCT00365716|O3|Outcome|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
1177397|NCT00366548|E6|Reported Event|13vPnC - P80 Toddler Dose|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
1177429|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
1177358|NCT00365716|O2|Outcome|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
1177359|NCT00365716|O1|Outcome|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
1177360|NCT00365716|E6|Reported Event|Extensions|"This group includes 241 international subjects, who either: (1) received placebo during the base study and continued in the Extension to receive a dose of GARDASIL (20/40/40/20 mcg formulation of qHPV vaccine) at Month 60 (plus 2 and 3 at Months 62 and 66, respectively, (2) received 3 doses of GARDASIL during the Base study and continued into the Extension to receive a fourth dose of GARDASIL at Month 60 for the purposes of investigating whether a fourth dose of vaccine (administered ~4.5 years following completion of a 3-dose primary regimen) induces HPV 6, 11, 16, and 18 antibody responses that characterize immune therapy.~Serious Adverse Events (SAEs) were collected during Extension 1 and Extension 2. Note that the N includes only the 241 subjects vaccinated during the Extension Periods; of the 258 subjects that entered either Extension, 17 subjects discontinued before being vaccinated and therefore are not included in this table."
1187645|NCT00330460|O1|Outcome|Alendronate 70 mg QW|
1177361|NCT00365716|E5|Reported Event|Placebo (mcg) (Aluminum Adjuvant) 450|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
1177362|NCT00365716|E4|Reported Event|Placebo (mcg) (Aluminum Adjuvant) 225|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
1177363|NCT00365716|E3|Reported Event|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
1177364|NCT00365716|E2|Reported Event|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.~There were 2 patients from the 40/40/40/40 group that were randomized, but were never vaccinated. As such, these 2 patients are not included in this table."
1177365|NCT00365716|E1|Reported Event|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.~There was one subject randomized to the quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP vaccine 20/40/40/20 mcg group who received the 225 mcg aluminum adjuvant placebo at the third vaccination visit. This subject was not included in the counts reported in the Adverse Event tables. No SAEs were reported for this subject.~There was 1 patient that was randomized, but never vaccinated. As such, that patient is not included in this table."
1177366|NCT00366548|B3|Baseline|Total|Total of all reporting groups
1177367|NCT00366548|B2|Baseline|13vPnC Without (-) Polysorbate 80|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) without (-) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose).
1177368|NCT00366548|B1|Baseline|13vPnC With (+) Polysorbate 80|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) with (+) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose).
1177369|NCT00366548|P2|Participant Flow|13vPnC Without (-) Polysorbate 80|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) without (-) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose).
1177398|NCT00366548|E5|Reported Event|13vPnC + P80 Toddler Dose|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
1177370|NCT00366548|P1|Participant Flow|13vPnC With (+) Polysorbate 80|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) with (+) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose).
1177371|NCT00366548|O2|Outcome|13vPnC - Polysorbate 80 After Toddler Dose|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at the 2 month visit, Pentaxim at the 3 and 4 month visits, and Priorix at 12 months of age (toddler dose).
1177372|NCT00366548|O1|Outcome|13vPnC + Polysorbate 80 After Toddler Dose|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant doses), and Priorix at 12 months of age (toddler dose).
1177373|NCT00366548|O2|Outcome|13vPnC - Polysorbate 80 After the Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
1177374|NCT00366548|O1|Outcome|13vPnC + Polysorbate 80 After the Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
1177866|NCT00364858|O2|Outcome|Q4 Cerezyme|Patients receiving Cerezyme one infusion every 4 weeks(Q4).
1177867|NCT00364858|O1|Outcome|Q2 Cerezyme|Patients receiving Cerezyme one infusion every 2 weeks (Q2).
1177375|NCT00366548|O8|Outcome|13vPnC - P80 Toddler Dose|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
1177376|NCT00366548|O7|Outcome|13vPnC + P80 Toddler Dose|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
1177377|NCT00366548|O6|Outcome|13vPnC - P80 Dose 3 Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
1177378|NCT00366548|O5|Outcome|13vPnC + P80 Dose 3 Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
1177379|NCT00366548|O4|Outcome|13vPnC - P80 Dose 2 Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
1177380|NCT00366548|O3|Outcome|13vPnC + P80 Dose 2 Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
1177381|NCT00366548|O2|Outcome|13vPnC - P 80 Dose 1 Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age (infant series, Dose 1).
1177382|NCT00366548|O1|Outcome|13vPnC + P80 Dose 1 Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age(infant series, Dose 1).
1177383|NCT00366548|O8|Outcome|13vPnC - P80 Toddler Dose|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series), and Priorix at 12 months of age (toddler dose).
1177384|NCT00366548|O7|Outcome|13vPnC + P80 Toddler Dose|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series), and Priorix at 12 months of age (toddler dose).
1177385|NCT00366548|O6|Outcome|13vPnC - P80 Dose 3 Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
1177386|NCT00366548|O5|Outcome|13vPnC + P80 Dose 3 Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
1177387|NCT00366548|O4|Outcome|13vPnC - P80 Dose 2 Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
1177388|NCT00366548|O3|Outcome|13vPnC + P80 Dose 2 Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
1177389|NCT00366548|O2|Outcome|13vPnC - P 80 Dose 1 Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age (infant series, Dose 1).
1177390|NCT00366548|O1|Outcome|13vPnC + P80 Dose 1 Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age(infant series, Dose 1).
1177391|NCT00366548|O2|Outcome|13vPnC - Polysorbate 80 After Toddler Dose|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at the 2 month visit, Pentaxim at the 3 and 4 month visits, and Priorix at 12 months of age (toddler dose).
1177392|NCT00366548|O1|Outcome|13vPnC + Polysorbate 80 After Toddler Dose|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant doses), and Priorix at 12 months of age (toddler dose).
1177393|NCT00366548|O2|Outcome|13vPnC - Polysorbate 80 After the Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
1177394|NCT00366548|O1|Outcome|13vPnC + Polysorbate 80 After the Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
1177395|NCT00366548|E8|Reported Event|13vPnC - P80 6-Month Follow-up|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
1177427|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
1177399|NCT00366548|E4|Reported Event|13vPnC - P80 Post-Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
1177400|NCT00366548|E3|Reported Event|13vPnC + P80 Post-Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
1177401|NCT00366548|E2|Reported Event|13vPnC - P 80 Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
1177402|NCT00366548|E1|Reported Event|13vPnC + P80 Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
1177403|NCT00366457|B1|Baseline|Gemcitabine, Bevacizumab and Erlotinib|"single-arm, no masking~Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects."
1177404|NCT00366457|P1|Participant Flow|Gemcitabine, Bevacizumab and Erlotinib|"single-arm, no masking~Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects."
1177405|NCT00366457|O1|Outcome|Gemcitabine, Bevacizumab and Erlotinib|"single-arm, no masking~Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects."
1177406|NCT00366457|O1|Outcome|Gemcitabine, Bevacizumab and Erlotinib|"single-arm, no masking~Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects."
1177407|NCT00366457|O1|Outcome|Gemcitabine, Bevacizumab and Erlotinib|"single-arm, no masking~Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects."
1177408|NCT00366457|O1|Outcome|Gemcitabine, Bevacizumab and Erlotinib|"single-arm, no masking~Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects."
1177409|NCT00366457|E1|Reported Event|Gemcitabine, Bevacizumab and Erlotinib|"single-arm, no masking~Bevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Erlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.~Gemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects."
1177410|NCT00366444|B3|Baseline|Total|Total of all reporting groups
1177411|NCT00366444|B2|Baseline|Placebo|Oral placebo capsule, every 6 hours
1177412|NCT00366444|B1|Baseline|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
1177413|NCT00366444|P2|Participant Flow|Placebo|Oral placebo capsule, every 6 hours
1177414|NCT00366444|P1|Participant Flow|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
1177415|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
1177416|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
1177417|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
1177418|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
1177419|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
1177420|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
1177421|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
1177422|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
1177423|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
1177424|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
1177425|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
1177426|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
1177430|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
1177431|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
1177432|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
1177433|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
1177434|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
1177435|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
1177436|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
1177437|NCT00366444|E2|Reported Event|Placebo|Oral placebo capsule, every 6 hours
1177438|NCT00366444|E1|Reported Event|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
1177439|NCT00366340|B3|Baseline|Total|Total of all reporting groups
1177440|NCT00366340|B2|Baseline|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
1177592|NCT00365547|O1|Outcome|Patients Evaluable for Tumor Response|Patients that met Solid Tumor Response Criteria (RECIST) criteria for partial response (at least a 30% decrease in the sum of the longest diameters of target lesions) and complete response (disappearance of all target lesions).
1177441|NCT00366340|B1|Baseline|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
1177442|NCT00366340|P2|Participant Flow|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
1177443|NCT00366340|P1|Participant Flow|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
1177444|NCT00366340|O2|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
1177445|NCT00366340|O1|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
1177446|NCT00366340|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
1177447|NCT00366340|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
1177448|NCT00366340|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 3 months (infant series).
1177449|NCT00366340|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 3 months (infant series).
1177450|NCT00366340|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2 months (infant series).
1177451|NCT00366340|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2 months (infant series).
1177452|NCT00366340|O8|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
1177453|NCT00366340|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
1177454|NCT00366340|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
1177455|NCT00366340|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
1177456|NCT00366340|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 3 months (infant series).
1177457|NCT00366340|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 3 months (infant series).
1177717|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177458|NCT00366340|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2 months (infant series).
1177459|NCT00366340|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2 months (infant series).
1177460|NCT00366340|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
1177461|NCT00366340|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
1177868|NCT00364858|O2|Outcome|Q4 Cerezyme|Patients receiving Cerezyme one infusion every 4 weeks(Q4).
1177462|NCT00366340|O2|Outcome|7vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
1177463|NCT00366340|O1|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
1177464|NCT00366340|O4|Outcome|7vPnC AfterToddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
1177465|NCT00366340|O3|Outcome|13vPnC AfterToddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
1177466|NCT00366340|O2|Outcome|7vPnC After Infant Series|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
1177467|NCT00366340|O1|Outcome|13vPnC After Infant Series|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
1177468|NCT00366340|O4|Outcome|7vPnC AfterToddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
1177469|NCT00366340|O3|Outcome|13vPnC AfterToddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
1177470|NCT00366340|O2|Outcome|7vPnC After Infant Series|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
1177471|NCT00366340|O1|Outcome|13vPnC After Infant Series|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
1177472|NCT00366340|O4|Outcome|7vPnC AfterToddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
1177473|NCT00366340|O3|Outcome|13vPnC AfterToddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
1177474|NCT00366340|O2|Outcome|7vPnC After Infant Series|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
1177475|NCT00366340|O1|Outcome|13vPnC After Infant Series|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
1177476|NCT00366340|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
1177477|NCT00366340|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
1177478|NCT00366340|O2|Outcome|7vPnC After Infant Series|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
1177854|NCT00364923|O1|Outcome|Evaluable Population|All patients who received at least one dose of pralatrexate and had an eligible PTCL histopathological subtype confirmed by central pathology review.
1177479|NCT00366340|O1|Outcome|13vPnC After Infant Series|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
1177480|NCT00366340|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
1177481|NCT00366340|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
1177869|NCT00364858|O1|Outcome|Q2 Cerezyme|Patients receiving Cerezyme one infusion every 2 weeks (Q2).
1177870|NCT00364858|E3|Reported Event|Total|
1187646|NCT00330460|O2|Outcome|Denosumab 60 mg Q6M|
1177482|NCT00366340|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
1177483|NCT00366340|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
1177484|NCT00366340|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
1177485|NCT00366340|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
1177486|NCT00366340|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
1177487|NCT00366340|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
1177488|NCT00366340|E8|Reported Event|7vPnC 6-Month Follow-up|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose). Adverse events were collected for approximately six months after last visit.
1177489|NCT00366340|E7|Reported Event|13vPnC 6-Month Follow-up|Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose). Adverse events were collected for approximately six months after last visit.
1177490|NCT00366340|E6|Reported Event|7vPnC Toddler Dose|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 12 months of age. Adverse events were collected for approximately one month after toddler dose.
1177491|NCT00366340|E5|Reported Event|13vPnC Toddler Dose|Participants received one single 0.5mL dose of 13vPnC at 12 months of age. Adverse events were collected for approximately one month after toddler dose.
1177492|NCT00366340|E4|Reported Event|7vPnC Post-Infant Series|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose). Adverse events were collected from approximately one month after dose 3 to toddler dose.
1177493|NCT00366340|E3|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months. Adverse events were collected from approximately one month after dose 3 to toddler dose.
1177494|NCT00366340|E2|Reported Event|7vPnC Infant Series|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 2, 3, 4 months. Adverse events were collected from dose 1 to approximately one month after dose 3.
1177495|NCT00366340|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months. Adverse events were collected from dose 1 to approximately one month after dose 3.
1177496|NCT00366301|B5|Baseline|Total|Total of all reporting groups
1177497|NCT00366301|B4|Baseline|Insulin Glargine Plus Metformin Pill|Insulin Glargine plus metformin pill
1177498|NCT00366301|B3|Baseline|Insulin Glargine Plus Placebo Pill|Insulin glargine plus placebo pill
1177499|NCT00366301|B2|Baseline|Metformin Pill|Metformin pill
1177500|NCT00366301|B1|Baseline|Placebo Pill|Placebo pill
1177501|NCT00366301|P4|Participant Flow|Insulin Glargine Plus Metformin Pill|Insulin Glargine plus metformin pill
1177502|NCT00366301|P3|Participant Flow|Insulin Glargine Plus Placebo Pill|Insulin glargine plus placebo pill
1177503|NCT00366301|P2|Participant Flow|Metformin Pill|Metformin pill
1177504|NCT00366301|P1|Participant Flow|Placebo Pill|Placebo pill
1177505|NCT00366301|O4|Outcome|Insulin Glargine Plus Metformin Pill|Insulin Glargine plus metformin pill
1177506|NCT00366301|O3|Outcome|Insulin Glargine Plus Placebo Pill|Insulin glargine plus placebo pill
1177507|NCT00366301|O2|Outcome|Metformin Pill|Metformin pill
1177508|NCT00366301|O1|Outcome|Placebo Pill|Placebo pill
1177509|NCT00366301|E4|Reported Event|Insulin Glargine Plus Metformin Pill|Insulin Glargine plus metformin pill
1177510|NCT00366301|E3|Reported Event|Insulin Glargine Plus Placebo Pill|Insulin glargine plus placebo pill
1177511|NCT00366301|E2|Reported Event|Metformin Pill|Metformin pill
1177512|NCT00366301|E1|Reported Event|Placebo Pill|Placebo pill
1177740|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177513|NCT00366275|B1|Baseline|Immunochemotherapy, in Vivo Purging and Autotransplant|2-4 courses every 3 weeks with rituximab 375 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 2 and cyclophosphamide 400 mg/m^2 on days 2-6. Courses were started if granulocytes >1.5 · 109/l. The phase of peripheral blood stem cells (PBSC) mobilization coupled rituximab 375 mg/m^2 on days 1 and 9 with high-dose cytarabine (AraC) 2 g/m^2 every 12 hours on days 2 and 3. Granulocyte colony-stimulating factor (G-CSF)(5 mcg/kg/day s.c.) was administered from day 6. High-dose chemotherapy with autotransplant consisted of BEAM [carmustine (BCNU), etoposide, Cytarabine (AraC), melphalan] followed by the infusion of in vivo purged peripheral blood stem cells (PBSC) + 2 consolidation doses of rituximab 375 mg/m^2 on days +14 and +21 after autotransplant.
1177593|NCT00365547|O1|Outcome|Patients Evaluable for Tumor Response|Patients that met Solid Tumor Response Criteria (RECIST) criteria for partial response (at least a 30% decrease in the sum of the longest diameters of target lesions) and complete response (disappearance of all target lesions).
1177514|NCT00366275|P1|Participant Flow|Immunochemotherapy, in Vivo Purging and Autotransplant|2-4 courses every 3 weeks with rituximab 375 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 2 and cyclophosphamide 400 mg/m^2 on days 2-6. Courses were started if granulocytes >1.5 · 109/l. The phase of peripheral blood stem cells (PBSC) mobilization coupled rituximab 375 mg/m^2 on days 1 and 9 with high-dose cytarabine (AraC) 2 g/m^2 every 12 hours on days 2 and 3. Granulocyte colony-stimulating factor (G-CSF)(5 mcg/kg/day s.c.) was administered from day 6. High-dose chemotherapy with autotransplant consisted of BEAM [carmustine (BCNU), etoposide, Cytarabine (AraC), melphalan] followed by the infusion of in vivo purged peripheral blood stem cells (PBSC) + 2 consolidation doses of rituximab 375 mg/m^2 on days +14 and +21 after autotransplant.
1177515|NCT00366275|O1|Outcome|Immunochemotherapy, in Vivo Purging and Autotransplant|2-4 courses every 3 weeks with rituximab 375 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 2 and cyclophosphamide 400 mg/m^2 on days 2-6. Courses were started if granulocytes >1.5 · 109/l. The phase of peripheral blood stem cells (PBSC) mobilization coupled rituximab 375 mg/m^2 on days 1 and 9 with high-dose cytarabine (AraC) 2 g/m^2 every 12 hours on days 2 and 3. Granulocyte colony-stimulating factor (G-CSF)(5 mcg/kg/day s.c.) was administered from day 6. High-dose chemotherapy with autotransplant consisted of BEAM [carmustine (BCNU), etoposide, Cytarabine (AraC), melphalan] followed by the infusion of in vivo purged peripheral blood stem cells (PBSC) + 2 consolidation doses of rituximab 375 mg/m^2 on days +14 and +21 after autotransplant.
1177516|NCT00366275|E1|Reported Event|Immunochemotherapy, in Vivo Purging and Autotransplant|2-4 courses every 3 weeks with rituximab 375 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 2 and cyclophosphamide 400 mg/m^2 on days 2-6. Courses were started if granulocytes >1.5 · 109/l. The phase of peripheral blood stem cells (PBSC) mobilization coupled rituximab 375 mg/m^2 on days 1 and 9 with high-dose cytarabine (AraC) 2 g/m^2 every 12 hours on days 2 and 3. Granulocyte colony-stimulating factor (G-CSF)(5 mcg/kg/day s.c.) was administered from day 6. High-dose chemotherapy with autotransplant consisted of BEAM [carmustine (BCNU), etoposide, Cytarabine (AraC), melphalan] followed by the infusion of in vivo purged peripheral blood stem cells (PBSC) + 2 consolidation doses of rituximab 375 mg/m^2 on days +14 and +21 after autotransplant.
1177517|NCT00366249|B3|Baseline|Total|Total of all reporting groups
1177518|NCT00366249|B2|Baseline|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
1177519|NCT00366249|B1|Baseline|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
1177520|NCT00366249|P2|Participant Flow|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
1177521|NCT00366249|P1|Participant Flow|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
1177522|NCT00366249|O2|Outcome|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
1177523|NCT00366249|O1|Outcome|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
1177524|NCT00366249|O2|Outcome|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
1177525|NCT00366249|O1|Outcome|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
1177526|NCT00366249|O2|Outcome|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
1177527|NCT00366249|O1|Outcome|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
1177528|NCT00366249|O2|Outcome|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
1177529|NCT00366249|O1|Outcome|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
1177530|NCT00366249|O2|Outcome|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
1177531|NCT00366249|O1|Outcome|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
1177532|NCT00366249|E2|Reported Event|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
1177533|NCT00366249|E1|Reported Event|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
1177534|NCT00366106|B1|Baseline|Treatment Group|All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
1177620|NCT00365417|E1|Reported Event|Chemo Plus Bevacizumab|Bevacizumab beginning concurrently with a sequential regimen of doxorubicin and cyclophosphamide followed by docetaxel and capecitabine as neoadjuvant therapy followed by postoperative bevacizumab alone for women with HER2 negative locally advanced breast cancer
1177535|NCT00366106|P1|Participant Flow|Treatment Group|All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
1177594|NCT00365547|O1|Outcome|Patients Evaluable for Tumor Response|Only patients that remained in the study for at least 2 months and had the tumor measurements necessary to meet RECIST criteria are included.
1177536|NCT00366106|O1|Outcome|Treatment Group|All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
1177537|NCT00366106|O1|Outcome|Treatment Group|All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
1177538|NCT00366106|O1|Outcome|Treatment Group|All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
1177539|NCT00366106|O1|Outcome|Treatment Group|All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
1177540|NCT00366106|E1|Reported Event|Treatment Group|All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
1177541|NCT00366028|B3|Baseline|Total|Total of all reporting groups
1177542|NCT00366028|B2|Baseline|Data Feedback|"Participants in this arm will be interviewed periodically and participate in the data feedback portion of the study but will not undergo any active intervention pertaining to the organizational model.~Data Feedback Only Model: The research team will periodically interview the facilities and provide them with reported hand hygiene data."
1177543|NCT00366028|B1|Baseline|Organizational Model|"Participants in this arm of the study will receive information regarding the organizational model and work closely with the research team throughout the project to implement various aspects of the model.~Organization Model: The organizational model contains three components: leadership support, a multidisciplinary redesign team, and management structures and processes to link the two. The research team will periodically interview the facilities and provide them with reported hand hygiene data."
1177544|NCT00366028|P2|Participant Flow|Data Feedback|"This arm is considered the control arm. Participants in this arm will be interviewed periodically and participate in the data feedback portion of the study but will not undergo any active intervention pertaining to the organizational model.~Data Feedback Model: This is considered the non-intervention arm. The research team will periodically interview the facilities and provide them with reported hand hygiene data."
1177545|NCT00366028|P1|Participant Flow|Organizational Model|"This arm is considered the intervention arm. Participants in this arm of the study will receive information regarding the organizational model and work closely with the research team throughout the project to implement various aspects of the model.~Organization Model: The organizational model contains three components: leadership support, a multidisciplinary redesign team, and management structures and processes to link the two."
1177546|NCT00366028|O2|Outcome|Data Feedback|"Participants in this arm were interviewed periodically and participated in the data feedback portion of the study but did not undergo any active intervention pertaining to the organizational model.~Data Feedback Model: This is considered the non-intervention arm. The research team periodically interviewed the facilities and provided them with reported hand hygiene data.~The Control Arm included 9 study sites (medical centers) in total. Only 5 of the study sites are included in analysis of this outcome measure due to incomplete hand hygiene data at 4 of the study sites. Of the 5 study sites included, there were 2 sites with high fidelity to the Organization Model and 3 sites with low fidelity to the Organizational model, even though the model was not specifically introduced to the control arm."
1177547|NCT00366028|O1|Outcome|Organizational Model|"Participants in this arm of the study received information regarding the organizational model and worked closely with the research team throughout the project to implement various aspects of the model.~Organization Model: The organizational model contains three components: leadership support, a multidisciplinary redesign team, and management structures and processes to link the two.~The Intervention Arm included 7 study sites (medical centers). Of the 7 sites there were 4 with high fidelity to the Organizational Model and 3 with low fidelity to the Organizational Model."
1177548|NCT00366028|O2|Outcome|Data Feedback|"Participants in this arm were interviewed periodically and participated in the data feedback portion of the study but did not undergo any active intervention pertaining to the organizational model.~Data Feedback Model: This is considered the non-intervention arm. The research team periodically interviewed the facilities and provided them with reported hand hygiene data.~The Control Arm included 735 individual participants across 9 study sites (medical centers) in total. Only 5 of the study sites are included in the reporting of outcome data due to incomplete data at 4 of the study sites."
1177632|NCT00365378|P3|Participant Flow|Extension|This group includes 400 subjects who received Monovalent HPV 16 L1 VLP vaccine or placebo during the base study. This includes subjects who previously discontinued from the study.
1177846|NCT00364949|O2|Outcome|PCOS|Polycystic Ovary Syndrome
1177549|NCT00366028|O1|Outcome|Organizational Model|"Participants in this arm of the study received information regarding the organizational model and worked closely with the research team throughout the project to implement various aspects of the model.~Organization Model: The organizational model contains three components: leadership support, a multidisciplinary redesign team, and management structures and processes to link the two.~The Intervention Arm included 889 individual participants across 7 study sites (medical centers)."
1177550|NCT00366028|E2|Reported Event|Data Feedback|"This arm is considered the control arm. Participants in this arm will be interviewed periodically and participate in the data feedback portion of the study but will not undergo any active intervention pertaining to the organizational model.~Data Feedback Model: This is considered the non-intervention arm. The research team will periodically interview the facilities and provide them with reported hand hygiene data."
1177551|NCT00366028|E1|Reported Event|Organizational Model|"This arm is considered the intervention arm. Participants in this arm of the study will receive information regarding the organizational model and work closely with the research team throughout the project to implement various aspects of the model.~Organization Model: The organizational model contains three components: leadership support, a multidisciplinary redesign team, and management structures and processes to link the two.~Data Feedback Model: This is considered the non-intervention arm. The research team will periodically interview the facilities and provide them with reported hand hygiene data."
1177552|NCT00365976|B3|Baseline|Total|Total of all reporting groups
1177553|NCT00365976|B2|Baseline|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
1177554|NCT00365976|B1|Baseline|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
1177555|NCT00365976|P2|Participant Flow|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
1177556|NCT00365976|P1|Participant Flow|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
1177557|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
1177558|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
1177559|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
1177560|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
1177561|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
1177562|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
1177563|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
1177564|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
1177565|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
1177566|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
1177567|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
1177568|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
1177569|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
1177570|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
1177571|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
1177572|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
1177573|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
1177574|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
1177575|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
1177576|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
1177577|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
1177578|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
1177579|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
1177580|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
1177581|NCT00365976|E2|Reported Event|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
1177582|NCT00365976|E1|Reported Event|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
1177583|NCT00365599|B1|Baseline|Vorinostat and Tamoxifen|Vorinostat and Tamoxifen as outlined in Intervention Descriptions
1177584|NCT00365599|P1|Participant Flow|Vorinostat and Tamoxifen|Vorinostat and Tamoxifen as outlined in Intervention Descriptions
1177585|NCT00365599|O1|Outcome|Vorinostat and Tamoxifen|Vorinostat and Tamoxifen as outlined in Intervention Descriptions
1177586|NCT00365599|O1|Outcome|Vorinostat and Tamoxifen|Vorinostat and Tamoxifen as outlined in Intervention Descriptions
1177587|NCT00365599|O1|Outcome|Vorinostat and Tamoxifen|Vorinostat and Tamoxifen as outlined in Intervention Descriptions
1177588|NCT00365599|E1|Reported Event|Vorinostat and Tamoxifen|Vorinostat and Tamoxifen as outlined in Intervention Descriptions
1177589|NCT00365547|B1|Baseline|Intent-To-Treat Population|Patients who enrolled and were scheduled to receive weekly topotecan (4 mg/m^2 will be given as a 30-minute intravenous infusion on days 1, 8, and 15 with a rest on day 22 and repeated every 28 days) and bi-weekly Avastin (bevacizumab given by IV infusion at the dose of 10 mg/kg on days 1 and 15 after topotecan administration)in patients with non-small cell lung cancer (NSCLC) who have failed prior systemic chemotherapy.
1177590|NCT00365547|P1|Participant Flow|Intent-To-Treat Population|Patients who enrolled and were scheduled to receive weekly topotecan (4 mg/m^2 will be given as a 30-minute intravenous infusion on days 1, 8, and 15 with a rest on day 22 and repeated every 28 days) and bi-weekly Avastin (bevacizumab given by IV infusion at the dose of 10 mg/kg on days 1 and 15 after topotecan administration)in patients with non-small cell lung cancer (NSCLC) who have failed prior systemic chemotherapy.
1177847|NCT00364949|O1|Outcome|Control|Control
1177591|NCT00365547|O1|Outcome|Intent-To-Treat Population|Patients who enrolled and were scheduled to receive weekly topotecan (4 mg/m^2 will be given as a 30-minute intravenous infusion on days 1, 8, and 15 with a rest on day 22 and repeated every 28 days) and bi-weekly Avastin (bevacizumab given by IV infusion at the dose of 10 mg/kg on days 1 and 15 after topotecan administration)in patients with non-small cell lung cancer (NSCLC) who have failed prior systemic chemotherapy.
1177595|NCT00365547|O1|Outcome|Intent-To-Treat Population|Patients who enrolled and were scheduled to receive weekly topotecan (4 mg/m^2 will be given as a 30-minute intravenous infusion on days 1, 8, and 15 with a rest on day 22 and repeated every 28 days) and bi-weekly Avastin (bevacizumab) given by intravenous (IV) infusion at the dose of 10 mg/kg on days 1 and 15 after topotecan administration)in patients with non-small cell lung cancer (NSCLC) who have failed prior systemic chemotherapy.
1177596|NCT00365547|E1|Reported Event|Safety Population|Patients who received treatment with weekly topotecan (4 mg/m^2 will be given as a 30-minute intravenous infusion on days 1, 8, and 15 with a rest on day 22 and repeated every 28 days) and bi-weekly Avastin (bevacizumab given by IV infusion at the dose of 10 mg/kg on days 1 and 15 after topotecan administration)in patients with non-small cell lung cancer (NSCLC) who have failed prior systemic chemotherapy.
1177597|NCT00365508|B3|Baseline|Total|Total of all reporting groups
1177598|NCT00365508|B2|Baseline|Arm II|Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
1177599|NCT00365508|B1|Baseline|Arm I|Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.
1177600|NCT00365508|P2|Participant Flow|Nicotine Lozenge|Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
1177601|NCT00365508|P1|Participant Flow|Nicotine Patch|Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.
1177602|NCT00365508|O2|Outcome|Arm II|Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
1177603|NCT00365508|O1|Outcome|Arm I|Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.
1177604|NCT00365508|O2|Outcome|Arm II|Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
1177605|NCT00365508|O1|Outcome|Arm I|Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.
1177606|NCT00365508|E2|Reported Event|Arm II|Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
1177607|NCT00365508|E1|Reported Event|Arm I|Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.
1177608|NCT00365456|B1|Baseline|PTH(1-84) or Risedronate|"PTH(1-84) received by 405 participants in Trial Period I~of those 405 participants, 282 received Risedronate in Trial Period II~of those 282 participants, 268 participant remained and 136 received PTH(1-84) and 132 received Risedronate in Trial Period III"
1177609|NCT00365456|P2|Participant Flow|Risedronate|
1177610|NCT00365456|P1|Participant Flow|PTH (1-84)|
1177611|NCT00365456|O2|Outcome|Risedronate|Regimen 2 = PTH (1-84) → Risedronate → Risedronate
1177612|NCT00365456|O1|Outcome|PTH (1-84)|Regimen 1 = PTH (1-84) → Risedronate → PTH (1-84)
1177613|NCT00365456|E2|Reported Event|Risedronate|Trial Period II SAEs and Trial Period III SAEs for subjects receiving risedronate
1177614|NCT00365456|E1|Reported Event|PTH (1-84)|Trial Period I SAEs and Trial Period III SAEs for subjects receiving PTH (1-84)
1177615|NCT00365417|B1|Baseline|Chemo Plus Bevacizumab|Bevacizumab beginning concurrently with a sequential regimen of doxorubicin and cyclophosphamide followed by docetaxel and capecitabine as neoadjuvant therapy followed by postoperative bevacizumab alone for women with HER2 negative locally advanced breast cancer
1177616|NCT00365417|P1|Participant Flow|Chemo Plus Bevacizumab|Bevacizumab beginning concurrently with a sequential regimen of doxorubicin and cyclophosphamide followed by docetaxel and capecitabine as neoadjuvant therapy followed by postoperative bevacizumab alone for women with HER2 negative locally advanced breast cancer
1177617|NCT00365417|O1|Outcome|Neoadjuvant Study Treatment|Doxorubicin, cyclophosphamide, and bevacizumab followed by docetaxel and capecitabine
1177618|NCT00365417|O1|Outcome|Neoadjuvant Study Treatment|Doxorubicin, cyclophosphamide, and bevacizumab followed by docetaxel and capecitabine
1177619|NCT00365417|O1|Outcome|Neoadjuvant Study Treatment|Doxorubicin, cyclophosphamide, and bevacizumab followed by docetaxel and capecitabine
1177848|NCT00364949|E2|Reported Event|PCOS|Polycystic Ovary Syndrome
1177849|NCT00364949|E1|Reported Event|Control|Control
1177621|NCT00365391|B1|Baseline|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by IHC for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, MAPK, and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
1177650|NCT00365365|P1|Participant Flow|Stratum 1 (AC->T + Bevacizumab)|"HER2-negative participants administered~doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by~docetaxel (T) + bevacizumab for 4 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
1177871|NCT00364858|E2|Reported Event|Q4 Cerezyme|Patients receiving Cerezyme one infusion every 4 weeks(Q4).
1177622|NCT00365391|P1|Participant Flow|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine epidermal growth factor receptor (EGFR) and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by immuno-histochemistry (IHC) for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, mitogen-activated protein kinase (MAPK), and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
1177623|NCT00365391|O1|Outcome|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by IHC for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, MAPK, and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
1177624|NCT00365391|O1|Outcome|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by IHC for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, MAPK, and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
1177625|NCT00365391|O1|Outcome|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by IHC for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, MAPK, and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
1177626|NCT00365391|O1|Outcome|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by IHC for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, MAPK, and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
1177627|NCT00365391|O1|Outcome|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by IHC for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, MAPK, and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
1177628|NCT00365391|E1|Reported Event|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by IHC for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, MAPK, and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
1177629|NCT00365378|B3|Baseline|Total|Total of all reporting groups
1177630|NCT00365378|B2|Baseline|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2, and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo from completion of the Vaccination Period at Month 7 through Month 48."
1177631|NCT00365378|B1|Baseline|HPV 16 L1 VLP (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2, and Month 6) with HPV (Human Papillomavirus) 16 Virus-Like Particle (VLP) Vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine from completion of the Vaccination Period at Month 7 through Month 48."
1177850|NCT00364923|B1|Baseline|Full Population|All patients who received at least one dose of pralatrexate
1177633|NCT00365378|P2|Participant Flow|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2, and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo from completion of the Vaccination Period at Month 7 through Month 48. (The Month 7 visit was to be scheduled to occur no earlier than 3 weeks and no later than 7 weeks following the Month 6 visit.)"
1177855|NCT00364923|O1|Outcome|Evaluable Population|All patients who received at least one dose of pralatrexate and had an eligible PTCL histopathological subtype confirmed by central pathology review.
1177634|NCT00365378|P1|Participant Flow|HPV 16 L1 VLP (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2, and Month 6) with HPV (Human Papillomavirus) 16 Virus-Like Particle (VLP) Vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine from completion of the Vaccination Period at Month 7 through Month 48. (The Month 7 visit was to be scheduled to occur no earlier than 3 weeks and no later than 7 weeks following the Month 6 visit.)"
1177635|NCT00365378|O2|Outcome|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2, and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo from completion of the Vaccination Period at Month 7 through Month 48."
1177636|NCT00365378|O1|Outcome|HPV 16 L1 VLP (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2, and Month 6) with HPV (Human Papillomavirus) 16 Virus-Like Particle (VLP) Vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine from completion of the Vaccination Period at Month 7 through Month 48."
1177637|NCT00365378|O2|Outcome|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2, and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo from completion of the Vaccination Period at Month 7 through Month 48."
1177638|NCT00365378|O1|Outcome|HPV 16 L1 VLP (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2, and Month 6) with HPV (Human Papillomavirus) 16 Virus-Like Particle (VLP) Vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine from completion of the Vaccination Period at Month 7 through Month 48."
1177639|NCT00365378|O2|Outcome|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2, and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo from completion of the Vaccination Period at Month 7 through Month 48."
1177640|NCT00365378|O1|Outcome|HPV 16 L1 VLP (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2, and Month 6) with HPV (Human Papillomavirus) 16 Virus-Like Particle (VLP) Vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine from completion of the Vaccination Period at Month 7 through Month 48."
1177641|NCT00365378|E3|Reported Event|Extension|This group includes 400 subjects who received Monovalent HPV 16 L1 VLP vaccine or placebo during the base study. This includes subjects who previously discontinued from the study.
1177642|NCT00365378|E2|Reported Event|Placebo (Group 2)|The number of subjects who actually received the vaccine material corresponding to the indicated vaccination group. There was one subject randomized to the HPV 16 L1 VLP vaccine group who received placebo and then discontinued study participation. There was 1 subject randomized to the placebo group who received one vaccination of HPV 16 L1 VLP vaccine and then discontinued study participation. These 2 subjects were included in the counts reported in the Adverse Event tables. There were 2 subjects randomized to the HPV 16 L1 VLP vaccine group and 2 subjects randomized to the placebo group and who received mixed vaccine material. These 4 subjects were not included in the counts reported in this table. Therefore, this table reports N=1191 (1193 minus 2) subjects vaccinated with HPV 16 L1 VLP vaccine and N=1196 (1198 minus 2) subjects vaccinated with placebo.
1177643|NCT00365378|E1|Reported Event|HPV 16 L1 VLP (Group 1)|The number of subjects who actually received the vaccine material corresponding to the indicated vaccination group. There was one subject randomized to the HPV 16 L1 VLP vaccine group who received placebo and then discontinued study participation. There was 1 subject randomized to the placebo group who received one vaccination of HPV 16 L1 VLP vaccine and then discontinued study participation. These 2 subjects were included in the counts reported in the Adverse Event tables. There were 2 subjects randomized to the HPV 16 L1 VLP vaccine group and 2 subjects randomized to the placebo group and who received mixed vaccine material. These 4 subjects were not included in the counts reported in this table. Therefore, this table reports N=1191 (1193 minus 2) subjects vaccinated with HPV 16 L1 VLP vaccine and N=1196 (1198 minus 2) subjects vaccinated with placebo.
1177644|NCT00365365|B4|Baseline|Total|Total of all reporting groups
1177645|NCT00365365|B3|Baseline|Stratum 3 (TCH + Bevacizumab).)|"All HER2-positive participants administered~docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab for 6 cycles followed by~bevacizumab and trastuzumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
1177646|NCT00365365|B2|Baseline|Stratum 2 (TAC + Bevacizumab)|"HER2-negative participants administered~docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
1177647|NCT00365365|B1|Baseline|Stratum 1 (AC->T + Bevacizumab)|"HER2-negative participants administered~doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by~docetaxel (T) + bevacizumab for 4 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
1177648|NCT00365365|P3|Participant Flow|Stratum 3 (TCH + Bevacizumab).)|"All HER2-positive participants administered~docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab for 6 cycles followed by~bevacizumab and trastuzumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
1177693|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177649|NCT00365365|P2|Participant Flow|Stratum 2 (TAC + Bevacizumab)|"HER2-negative participants administered~docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
1177856|NCT00364923|E1|Reported Event|Full Population|All patients who received at least one dose of pralatrexate
1177857|NCT00364858|B3|Baseline|Total|Total of all reporting groups
1177651|NCT00365365|O3|Outcome|Stratum 3 (TCH + Bevacizumab).)|"All HER2-positive participants administered~docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab for 6 cycles followed by~bevacizumab and trastuzumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
1177652|NCT00365365|O2|Outcome|Stratum 2 (TAC + Bevacizumab)|"HER2-negative participants administered~docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
1177653|NCT00365365|O1|Outcome|Stratum 1 (AC->T + Bevacizumab)|"HER2-negative participants administered~doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by~docetaxel (T) + bevacizumab for 4 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
1177654|NCT00365365|O3|Outcome|Stratum 3 (TCH + Bevacizumab).)|"All HER2-positive participants administered~docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab for 6 cycles followed by~bevacizumab and trastuzumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
1177655|NCT00365365|O2|Outcome|Stratum 2 (TAC + Bevacizumab)|"HER2-negative participants administered~docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
1177656|NCT00365365|O1|Outcome|Stratum 1 (AC->T + Bevacizumab)|"HER2-negative participants administered~doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by~docetaxel (T) + bevacizumab for 4 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
1177657|NCT00365365|O3|Outcome|Stratum 3 (TCH + Bevacizumab).)|"All HER2-positive participants administered~docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab for 6 cycles followed by~bevacizumab and trastuzumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
1177658|NCT00365365|O2|Outcome|Stratum 2 (TAC + Bevacizumab)|"HER2-negative participants administered~docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
1177659|NCT00365365|O1|Outcome|Stratum 1 (AC->T + Bevacizumab)|"HER2-negative participants administered~doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by~docetaxel (T) + bevacizumab for 4 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
1177660|NCT00365365|E3|Reported Event|TCH + Bevacizumab|"All HER2-positive participants administered~docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab for 6 cycles followed by~bevacizumab and trastuzumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
1177661|NCT00365365|E2|Reported Event|TAC + Bevacizumab|"HER2-negative participants administered~docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
1177662|NCT00365365|E1|Reported Event|AC->T + Bevacizumab|"HER2-negative participants administered~doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by~docetaxel (T) + bevacizumab for 4 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
1177663|NCT00365352|B4|Baseline|Total|Total of all reporting groups
1177664|NCT00365352|B3|Baseline|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
1177665|NCT00365352|B2|Baseline|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177666|NCT00365352|B1|Baseline|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177667|NCT00365352|P3|Participant Flow|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
1177668|NCT00365352|P2|Participant Flow|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177669|NCT00365352|P1|Participant Flow|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177670|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
1177694|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
1177671|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177672|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177673|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
1177674|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177675|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177676|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
1177677|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177678|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177679|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
1177680|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177681|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177682|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
1177683|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177684|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177685|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
1177686|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177687|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177688|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
1177689|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177690|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177691|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
1177692|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177964|NCT00364819|O1|Outcome|Open Label Study Arm|"Primary Biliary Cirrhosis~rituximab: rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours"
1177695|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177696|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177697|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
1177698|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177699|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177700|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
1177701|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177702|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177703|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
1177704|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177705|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177706|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
1177707|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177708|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177709|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
1177710|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177711|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177712|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
1177713|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177714|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177715|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
1177716|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177965|NCT00364819|O1|Outcome|Open Label Study Arm|"Primary Biliary Cirrhosis~rituximab: rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours"
1177718|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
1177858|NCT00364858|B2|Baseline|Q4 Cerezyme|Patients receiving Cerezyme one infusion every 4 weeks(Q4).
1177859|NCT00364858|B1|Baseline|Q2 Cerezyme|Patients receiving Cerezyme one infusion every 2 weeks (Q2).
1177860|NCT00364858|P2|Participant Flow|Q4 Cerezyme|Patients receiving Cerezyme one infusion every 4 weeks(Q4).
1177719|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177720|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177721|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
1177722|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177723|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177724|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
1177725|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177726|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177727|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
1177728|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177729|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177730|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
1177731|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177732|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177733|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg Taken Orally Once a Day|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
1177734|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 Milligrams(mg) Taken Orally|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177735|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177736|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
1177737|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177738|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177739|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177966|NCT00364819|O1|Outcome|Open Label Study Arm|"Primary Biliary Cirrhosis~rituximab: rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours"
1177861|NCT00364858|P1|Participant Flow|Q2 Cerezyme|Patients receiving Cerezyme one infusion every 2 weeks (Q2).
1177862|NCT00364858|O2|Outcome|Q4 Cerezyme|Patients receiving Cerezyme one infusion every 4 weeks(Q4).
1187647|NCT00330460|O1|Outcome|Alendronate 70 mg QW|
1177741|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177742|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177743|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
1177744|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177745|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
1177746|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177747|NCT00365352|E3|Reported Event|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
1177748|NCT00365352|E2|Reported Event|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177749|NCT00365352|E1|Reported Event|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
1177750|NCT00365300|B3|Baseline|Total|Total of all reporting groups
1177751|NCT00365300|B2|Baseline|Placebo|Double Blind Treatment-withdrawal phase (weeks 5-8): Matching placebo. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
1177752|NCT00365300|B1|Baseline|Pantoprazole Sodium Granules|Double Blind Treatment-withdrawal phase (weeks 5-8) Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥ 7 kg) in an oral suspension. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received: Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
1177753|NCT00365300|P2|Participant Flow|Placebo|Double Blind Treatment-withdrawal phase (weeks 5-8): Matching placebo. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
1177754|NCT00365300|P1|Participant Flow|Pantoprazole Sodium Granules|Double Blind Treatment-withdrawal phase (weeks 5-8) Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥ 7 kg) in an oral suspension. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received: Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
1177755|NCT00365300|O2|Outcome|Placebo|Double Blind Treatment-withdrawal phase (weeks 5-8): Matching placebo. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
1177756|NCT00365300|O1|Outcome|Pantoprazole Sodium Granules|Double Blind Treatment-withdrawal phase (weeks 5-8) Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥ 7 kg) in an oral suspension. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received: Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
1177757|NCT00365300|E5|Reported Event|Follow-up|
1177758|NCT00365300|E4|Reported Event|Placebo (Double-blind Phase)|
1177759|NCT00365300|E3|Reported Event|Pantoprazole Sodium Granules (Double-blind Phase)|
1177760|NCT00365300|E2|Reported Event|Pantoprazole Sodium Granules (Open-Label Phase)|
1177761|NCT00365300|E1|Reported Event|Screening|
1177762|NCT00365274|B1|Baseline|SGN-30 + Combination Chemotherapy|"Monoclonal antibody SGN-30 monotherapy: SGN-30 12 mg/kg weekly intravenously (IV) over 2 hours once weekly for 3 weeks.~SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, SGN-30 12 mg/kg IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses."
1177763|NCT00365274|P1|Participant Flow|SGN-30 + Combination Chemotherapy|"Monoclonal antibody SGN-30 monotherapy: SGN-30 12 mg/kg weekly intravenously (IV) over 2 hours once weekly for 3 weeks.~SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, SGN-30 12 mg/kg IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses."
1177851|NCT00364923|P1|Participant Flow|Full Population|All patients who received at least one dose of pralatrexate. Patients continued pralatrexate until protocol defined criteria for discontinuation or 24 months of treatment.
1177764|NCT00365274|O1|Outcome|SGN-30 + Combination Chemotherapy|"Monoclonal antibody SGN-30 monotherapy: SGN-30 12 mg/kg weekly intravenously (IV) over 2 hours once weekly for 3 weeks.~SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, SGN-30 12 mg/kg IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses."
1177765|NCT00365274|E1|Reported Event|SGN-30 + Combination Chemotherapy|"Monoclonal antibody SGN-30 monotherapy: SGN-30 12 mg/kg weekly intravenously (IV) over 2 hours once weekly for 3 weeks.~SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, SGN-30 12 mg/kg IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses."
1177766|NCT00365261|B3|Baseline|Total|Total of all reporting groups
1177767|NCT00365261|B2|Baseline|Placebo|receipt of placebo
1177768|NCT00365261|B1|Baseline|Eszopiclone|receipt of active drug
1177769|NCT00365261|P2|Participant Flow|Placebo|receipt of placebo
1177770|NCT00365261|P1|Participant Flow|Eszopiclone|receipt of active drug
1177771|NCT00365261|O2|Outcome|Placebo|placebo
1177772|NCT00365261|O1|Outcome|Eszopiclone|active drug
1177773|NCT00365261|O2|Outcome|Placebo|"placebo~Placebo: placebo 2 to 3 mg po at bedtime"
1177774|NCT00365261|O1|Outcome|Eszopiclone|"active drug~Eszopiclone: eszopiclone 2 to 3 mg po at bedtime"
1177775|NCT00365261|O2|Outcome|Placebo|placebo
1177776|NCT00365261|O1|Outcome|Eszopiclone|active drug
1177777|NCT00365261|E2|Reported Event|Placebo|receipt of placebo
1177778|NCT00365261|E1|Reported Event|Eszopiclone|receipt of active drug
1177779|NCT00365209|B1|Baseline|Curcumin|"Stage 1: Patients receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Patients receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
1177780|NCT00365209|P1|Participant Flow|Curcumin|"Stage 1: Particpants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Particpants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
1177781|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
1177782|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
1177783|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
1177784|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
1177785|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
1177786|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
1177787|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
1177788|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
1177852|NCT00364923|O1|Outcome|Evaluable Population|All patients who received at least one dose of pralatrexate and had an eligible PTCL histopathological subtype confirmed by central pathology review.
1177967|NCT00364819|O1|Outcome|Open Label Study Arm|"Primary Biliary Cirrhosis~rituximab: rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours"
1177789|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
1177790|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
1177791|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
1177792|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
1177793|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
1177794|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
1177795|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
1177796|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
1177797|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
1177798|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
1177799|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
1177800|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
1177801|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
1177802|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
1177803|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
1177853|NCT00364923|O1|Outcome|Evaluable Population|All patients who received at least one dose of pralatrexate and had an eligible PTCL histopathological subtype confirmed by central pathology review.
1177804|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
1177805|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
1177806|NCT00365209|E2|Reported Event|Stage2 4 g Curcumin|"Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
1177807|NCT00365209|E1|Reported Event|Stage1 2 g Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
1177808|NCT00365144|B1|Baseline|Bevacizumab Plus Erlotinib|Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
1177809|NCT00365144|P1|Participant Flow|Bevacizumab Plus Erlotinib|Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
1177810|NCT00365144|O1|Outcome|Bevacizumab Plus Erlotinib|Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
1177811|NCT00365144|O1|Outcome|Bevacizumab Plus Erlotinib|Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
1177812|NCT00365144|O1|Outcome|Bevacizumab Plus Erlotinib|Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
1177813|NCT00365144|E1|Reported Event|Bevacizumab Plus Erlotinib|Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
1177814|NCT00365105|B3|Baseline|Total|Total of all reporting groups
1177815|NCT00365105|B2|Baseline|Zoledronic Acid + Radopharmaceuticals|Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
1177816|NCT00365105|B1|Baseline|Zoledronic Acid|Zoledronic acid, vitamin D and calcium supplements.
1177817|NCT00365105|P2|Participant Flow|Zoledronic Acid + Radopharmaceuticals|Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
1177818|NCT00365105|P1|Participant Flow|Zoledronic Acid|Zoledronic acid, vitamin D and calcium supplements.
1177819|NCT00365105|O2|Outcome|Zoledronic Acid + Radopharmaceuticals|Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
1177820|NCT00365105|O1|Outcome|Zoledronic Acid|Zoledronic acid, vitamin D and calcium supplements.
1177821|NCT00365105|E2|Reported Event|Zoledronic Acid + Radopharmaceuticals|Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
1177822|NCT00365105|E1|Reported Event|Zoledronic Acid|Zoledronic acid, vitamin D and calcium supplements.
1177823|NCT00365053|B1|Baseline|Treatment (Belinostat)|"Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
1177824|NCT00365053|P1|Participant Flow|Treatment (Belinostat)|"Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
1177825|NCT00365053|O1|Outcome|Treatment (Belinostat)|"Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
1177826|NCT00365053|O1|Outcome|Treatment (Belinostat)|"Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
1177827|NCT00365053|O1|Outcome|Treatment (Belinostat)|"Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
1177828|NCT00365053|E1|Reported Event|Treatment (Belinostat)|"Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
1177829|NCT00364949|B3|Baseline|Total|Total of all reporting groups
1177830|NCT00364949|B2|Baseline|PCOS|Polycystic Ovary Syndrome
1177831|NCT00364949|B1|Baseline|Control|Control
1177832|NCT00364949|P2|Participant Flow|PCOS|Polycystic Ovary Syndrome
1177833|NCT00364949|P1|Participant Flow|Control|Control
1177834|NCT00364949|O2|Outcome|PCOS|Polycystic Ovary Syndrome
1177835|NCT00364949|O1|Outcome|Control|Control
1177836|NCT00364949|O2|Outcome|PCOS|Polycystic Ovary Syndrome
1177837|NCT00364949|O1|Outcome|Control|Control
1177838|NCT00364949|O2|Outcome|PCOS|Polycystic Ovary Syndrome
1177839|NCT00364949|O1|Outcome|Control|Control
1177840|NCT00364949|O2|Outcome|PCOS|Polycystic Ovary Syndrome
1177841|NCT00364949|O1|Outcome|Control|Control
1177842|NCT00364949|O2|Outcome|PCOS|Polycystic Ovary Syndrome
1177843|NCT00364949|O1|Outcome|Control|Control
1177844|NCT00364949|O2|Outcome|PCOS|Polycystic Ovary Syndrome
1177845|NCT00364949|O1|Outcome|Control|Control
1177872|NCT00364858|E1|Reported Event|Q2 Cerezyme|Patients receiving Cerezyme one infusion every 2 weeks (Q2).
1177873|NCT00364845|B3|Baseline|Total|Total of all reporting groups
1177874|NCT00364845|B2|Baseline|Placebo|Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
1177875|NCT00364845|B1|Baseline|Darbepoetin Alfa|Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
1177876|NCT00364845|P2|Participant Flow|Placebo|Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
1177877|NCT00364845|P1|Participant Flow|Darbepoetin Alfa|Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
1177878|NCT00364845|O2|Outcome|Placebo|Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
1177879|NCT00364845|O1|Outcome|Darbepoetin Alfa|Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
1177880|NCT00364845|O2|Outcome|Placebo|Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
1177881|NCT00364845|O1|Outcome|Darbepoetin Alfa|Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
1177882|NCT00364845|O2|Outcome|Placebo|Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
1177883|NCT00364845|O1|Outcome|Darbepoetin Alfa|Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
1177884|NCT00364845|O2|Outcome|Placebo|Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
1177885|NCT00364845|O1|Outcome|Darbepoetin Alfa|Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
1177886|NCT00364845|E2|Reported Event|Placebo|Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
1177887|NCT00364845|E1|Reported Event|Darbepoetin Alfa|Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
1177888|NCT00364832|B10|Baseline|Total|Total of all reporting groups
1177889|NCT00364832|B9|Baseline|Cohort I (1.2/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177890|NCT00364832|B8|Baseline|Cohort H (1.2/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177891|NCT00364832|B7|Baseline|Cohort G (1.2/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177892|NCT00364832|B6|Baseline|Cohort F (0.8/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177968|NCT00364819|E1|Reported Event|Open Label Study Arm|"Primary Biliary Cirrhosis~rituximab: rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours"
1177893|NCT00364832|B5|Baseline|Cohort E (0.8/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177894|NCT00364832|B4|Baseline|Cohort D (0.8/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177895|NCT00364832|B3|Baseline|Cohort C (0.4/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177896|NCT00364832|B2|Baseline|Cohort B (0.4/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177897|NCT00364832|B1|Baseline|Cohort A (0.4/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1178149|NCT00364533|O3|Outcome|Tapentadol IR Fixed Dose 100 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
1177898|NCT00364832|P12|Participant Flow|RO0503821 (1x/ 4 Weeks)|Eligible participants were administered SC RO0503821 once every four weeks (1x/ 4 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort C, Cohort F, and Cohort I, respectively for 21 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177899|NCT00364832|P11|Participant Flow|RO0503821 (1x/ 3 Weeks)|Eligible participants were administered SC RO0503821 once every three weeks (1x/ 3 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort B, Cohort E, and Cohort H, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177900|NCT00364832|P10|Participant Flow|RO0503821 (1x/ Week)|Eligible participants were administered SC RO0503821 once weekly (1x/ week) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kilogram of the previous weekly ESA dose in Cohort A, Cohort D, and Cohort G, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177901|NCT00364832|P9|Participant Flow|Cohort I (1.2/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177902|NCT00364832|P8|Participant Flow|Cohort H (1.2/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177903|NCT00364832|P7|Participant Flow|Cohort G (1.2/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177904|NCT00364832|P6|Participant Flow|Cohort F (0.8/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177905|NCT00364832|P5|Participant Flow|Cohort E (0.8/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177906|NCT00364832|P4|Participant Flow|Cohort D (0.8/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177907|NCT00364832|P3|Participant Flow|Cohort C (0.4/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177908|NCT00364832|P2|Participant Flow|Cohort B (0.4/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177925|NCT00364832|O6|Outcome|Cohort F (0.8/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177909|NCT00364832|P1|Participant Flow|Cohort A (0.4/150, 1x/ Week)|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneous (SC) using a dose conversion factor of 0.4/150 microgram (mcg)/ kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177910|NCT00364832|O3|Outcome|RO0503821 (1x/ 4 Weeks)|Eligible participants were administered subcutaneous (SC) RO0503821 once every four weeks (1x/ 4 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort C, Cohort F, and Cohort I, respectively for 21 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177911|NCT00364832|O2|Outcome|RO0503821 (1x/ 3 Weeks)|Eligible participants were administered subcutaneous (SC) RO0503821 once every three weeks (1x/ 3 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort B, Cohort E, and Cohort H, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1178150|NCT00364533|O2|Outcome|Tapentadol IR Fixed Dose 75 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
1178151|NCT00364533|O1|Outcome|Tapentadol IR Fixed Dose 50 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
1178152|NCT00364533|O5|Outcome|Placebo Fixed Dose|Matching placebo taken by mouth every 4-6 hours for 3 days
1177912|NCT00364832|O1|Outcome|RO0503821 (1x/ Week)|Eligible participants were administered subcutaneous (SC) RO0503821 once weekly (1x/ week) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 microgram (mcg)/kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose in Cohort A, Cohort D, and Cohort G, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177913|NCT00364832|O9|Outcome|Cohort I (1.2/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177914|NCT00364832|O8|Outcome|Cohort H (1.2/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177915|NCT00364832|O7|Outcome|Cohort G (1.2/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177916|NCT00364832|O6|Outcome|Cohort F (0.8/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177917|NCT00364832|O5|Outcome|Cohort E (0.8/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177918|NCT00364832|O4|Outcome|Cohort D (0.8/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177919|NCT00364832|O3|Outcome|Cohort C (0.4/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177920|NCT00364832|O2|Outcome|Cohort B (0.4/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177921|NCT00364832|O1|Outcome|Cohort A (0.4/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177922|NCT00364832|O9|Outcome|Cohort I (1.2/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177923|NCT00364832|O8|Outcome|Cohort H (1.2/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177924|NCT00364832|O7|Outcome|Cohort G (1.2/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177961|NCT00364819|B1|Baseline|Open Label Study Arm|"Primary Biliary Cirrhosis~rituximab: rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours"
1177962|NCT00364819|P1|Participant Flow|Open Label Study Arm|"Primary Biliary Cirrhosis~rituximab: rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours"
1177926|NCT00364832|O5|Outcome|Cohort E (0.8/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177927|NCT00364832|O4|Outcome|Cohort D (0.8/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177928|NCT00364832|O3|Outcome|Cohort C (0.4/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177929|NCT00364832|O2|Outcome|Cohort B (0.4/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1187648|NCT00330460|O2|Outcome|Denosumab 60 mg Q6M|
1177930|NCT00364832|O1|Outcome|Cohort A (0.4/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177931|NCT00364832|O9|Outcome|Cohort I (1.2/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177932|NCT00364832|O8|Outcome|Cohort H (1.2/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177933|NCT00364832|O7|Outcome|Cohort G (1.2/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177934|NCT00364832|O6|Outcome|Cohort F (0.8/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177935|NCT00364832|O5|Outcome|Cohort E (0.8/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177936|NCT00364832|O4|Outcome|Cohort D (0.8/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177937|NCT00364832|O3|Outcome|Cohort C (0.4/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177938|NCT00364832|O2|Outcome|Cohort B (0.4/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177939|NCT00364832|O1|Outcome|Cohort A (0.4/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177940|NCT00364832|O9|Outcome|Cohort I (1.2/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177941|NCT00364832|O8|Outcome|Cohort H (1.2/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177942|NCT00364832|O7|Outcome|Cohort G (1.2/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177943|NCT00364832|O6|Outcome|Cohort F (0.8/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177963|NCT00364819|O1|Outcome|Open Label Study Arm|"Primary Biliary Cirrhosis~rituximab: rituximab 1000 mg IV day 1 and 15, given over 5 - 6 hours"
1177969|NCT00364793|B5|Baseline|Total|Total of all reporting groups
1177944|NCT00364832|O5|Outcome|Cohort E (0.8/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177945|NCT00364832|O4|Outcome|Cohort D (0.8/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177946|NCT00364832|O3|Outcome|Cohort C (0.4/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177947|NCT00364832|O2|Outcome|Cohort B (0.4/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177948|NCT00364832|O1|Outcome|Cohort A (0.4/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177949|NCT00364832|O9|Outcome|Cohort I (1.2/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177950|NCT00364832|O8|Outcome|Cohort H (1.2/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177951|NCT00364832|O7|Outcome|Cohort G (1.2/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177952|NCT00364832|O6|Outcome|Cohort F (0.8/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177953|NCT00364832|O5|Outcome|Cohort E (0.8/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177954|NCT00364832|O4|Outcome|Cohort D (0.8/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177955|NCT00364832|O3|Outcome|Cohort C (0.4/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177956|NCT00364832|O2|Outcome|Cohort B (0.4/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177957|NCT00364832|O1|Outcome|Cohort A (0.4/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177958|NCT00364832|E3|Reported Event|RO0503821 (1x/ 4 Weeks)|Eligible participants were administered subcutaneous (SC) RO0503821 once every four weeks (1x/ 4 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort C, Cohort F, and Cohort I, respectively for 21 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177959|NCT00364832|E2|Reported Event|RO0503821 (1x/ 3 Weeks)|Eligible participants were administered subcutaneous (SC) RO0503821 once every three weeks (1x/ 3 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort B, Cohort E, and Cohort H, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177960|NCT00364832|E1|Reported Event|RO0503821 (1x/ Week)|Eligible participants were administered subcutaneous (SC) RO0503821 once weekly (1x/ week) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 microgram (mcg)/kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose in Cohort A, Cohort D, and Cohort G, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1177970|NCT00364793|B4|Baseline|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1177971|NCT00364793|B3|Baseline|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178153|NCT00364533|O4|Outcome|Oxycodone HCL IR Fixed Dose 10 mg|oxycodone 10mg taken by mouth every 4-6 hours for 3 days
1178154|NCT00364533|O3|Outcome|Tapentadol IR Fixed Dose 100 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
1178155|NCT00364533|O2|Outcome|Tapentadol IR Fixed Dose 75 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
1177972|NCT00364793|B2|Baseline|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1177973|NCT00364793|B1|Baseline|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1177974|NCT00364793|P4|Participant Flow|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1177975|NCT00364793|P3|Participant Flow|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1177976|NCT00364793|P2|Participant Flow|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1177977|NCT00364793|P1|Participant Flow|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and emtricitabine (FTC) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1177978|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1177979|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178137|NCT00364533|P5|Participant Flow|Placebo Fixed Dose|Matching placebo taken by mouth every 4-6 hours for 3 days
1186108|NCT00337571|O3|Outcome|Aripiprazole 10 mg|
1177980|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1177981|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1177982|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1177983|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1177984|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1177985|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1177986|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1177987|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1177988|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1177989|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1177990|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178475|NCT00363168|B2|Baseline|Ranibizumab Dose B|0.5 mg/0.05 ml intravitreal injection
1177991|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1177992|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1177993|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1177994|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1177995|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1177996|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1177997|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1177998|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1177999|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178000|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178001|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178476|NCT00363168|B1|Baseline|Ranibizumab Dose A|0.3 mg/0.05 ml intravitreal injection
1178002|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178030|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178003|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178004|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178005|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178006|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178007|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178008|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178009|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178010|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178129|NCT00364611|E2|Reported Event|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
1186109|NCT00337571|O2|Outcome|Aripiprazole 5 mg|
1178031|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178011|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178012|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178013|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178014|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178015|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178016|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178017|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178018|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178019|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178138|NCT00364533|P4|Participant Flow|Oxycodone HCL IR Fixed Dose 10 mg|oxycodone 10mg taken by mouth every 4-6 hours for 3 days
1186110|NCT00337571|O1|Outcome|Placebo|
1178020|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178021|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178022|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178023|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178024|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178025|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178026|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178027|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178028|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178029|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178130|NCT00364611|E1|Reported Event|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
1178032|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178033|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178034|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178035|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178036|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178037|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178038|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178039|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178040|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178131|NCT00364533|B6|Baseline|Total|Total of all reporting groups
1178041|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178042|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178043|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178044|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178045|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178046|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178047|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178048|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178049|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178050|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178051|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178477|NCT00363168|P2|Participant Flow|Ranibizumab Dose B|0.5 mg/0.05 ml intravitreal injection
1178052|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178064|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178053|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178054|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178055|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178056|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178057|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178058|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178059|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178060|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178061|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178062|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178132|NCT00364533|B5|Baseline|Placebo Fixed Dose|Matching placebo taken by mouth every 4-6 hours for 3 days
1186111|NCT00337571|O4|Outcome|Aripiprazole 15 mg|
1178063|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178065|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178066|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178067|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178068|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178069|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178070|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178071|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178072|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178073|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178133|NCT00364533|B4|Baseline|Oxycodone HCL IR Fixed Dose 10 mg|oxycodone 10mg taken by mouth every 4-6 hours for 3 days
1186112|NCT00337571|O3|Outcome|Aripiprazole 10 mg|
1178074|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178096|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178075|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178076|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178077|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178078|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178079|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178080|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178081|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178082|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178083|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178084|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178478|NCT00363168|P1|Participant Flow|Ranibizumab Dose A|0.3 mg/0.05 ml intravitreal injection
1178097|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178085|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178086|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178087|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178088|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178089|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178090|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178091|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178092|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178093|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178094|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178095|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178098|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178099|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178100|NCT00364793|O5|Outcome|Total Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.
1178101|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178102|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178103|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178104|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178105|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178106|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178107|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178134|NCT00364533|B3|Baseline|Tapentadol IR Fixed Dose 100 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
1178108|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178144|NCT00364533|O3|Outcome|Tapentadol IR Fixed Dose 100 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
1178145|NCT00364533|O2|Outcome|Tapentadol IR Fixed Dose 75 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
1178146|NCT00364533|O1|Outcome|Tapentadol IR Fixed Dose 50 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
1178147|NCT00364533|O5|Outcome|Placebo Fixed Dose|Matching placebo taken by mouth every 4-6 hours for 3 days
1178148|NCT00364533|O4|Outcome|Oxycodone HCL IR Fixed Dose 10 mg|oxycodone 10mg taken by mouth every 4-6 hours for 3 days
1178109|NCT00364793|E1|Reported Event|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
1178110|NCT00364611|B3|Baseline|Total|Total of all reporting groups
1178111|NCT00364611|B2|Baseline|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
1178112|NCT00364611|B1|Baseline|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
1178113|NCT00364611|P2|Participant Flow|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
1178114|NCT00364611|P1|Participant Flow|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
1178115|NCT00364611|O2|Outcome|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
1178116|NCT00364611|O1|Outcome|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
1178117|NCT00364611|O2|Outcome|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
1178118|NCT00364611|O1|Outcome|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
1178119|NCT00364611|O2|Outcome|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
1178120|NCT00364611|O1|Outcome|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
1178121|NCT00364611|O2|Outcome|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
1178122|NCT00364611|O1|Outcome|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
1178123|NCT00364611|O2|Outcome|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
1178124|NCT00364611|O1|Outcome|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
1178125|NCT00364611|O2|Outcome|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
1178126|NCT00364611|O1|Outcome|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
1178127|NCT00364611|O2|Outcome|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
1178128|NCT00364611|O1|Outcome|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
1178135|NCT00364533|B2|Baseline|Tapentadol IR Fixed Dose 75 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
1178136|NCT00364533|B1|Baseline|Tapentadol IR Fixed Dose 50 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
1178139|NCT00364533|P3|Participant Flow|Tapentadol IR Fixed Dose 100 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
1178140|NCT00364533|P2|Participant Flow|Tapentadol IR Fixed Dose 75 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
1178141|NCT00364533|P1|Participant Flow|Tapentadol IR Fixed Dose 50 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
1178142|NCT00364533|O5|Outcome|Placebo Fixed Dose|Matching placebo taken by mouth every 4-6 hours for 3 days
1178143|NCT00364533|O4|Outcome|Oxycodone HCL IR Fixed Dose 10 mg|oxycodone 10mg taken by mouth every 4-6 hours for 3 days
1178156|NCT00364533|O1|Outcome|Tapentadol IR Fixed Dose 50 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
1178157|NCT00364533|E5|Reported Event|Placebo Fixed Dose|Matching placebo taken by mouth every 4-6 hours for 3 days
1178158|NCT00364533|E4|Reported Event|Oxycodone HCL IR Fixed Dose 10 mg|oxycodone 10mg taken by mouth every 4-6 hours for 3 days
1178159|NCT00364533|E3|Reported Event|Tapentadol IR Fixed Dose 100 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
1178160|NCT00364533|E2|Reported Event|Tapentadol IR Fixed Dose 75 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
1178161|NCT00364533|E1|Reported Event|Tapentadol IR Fixed Dose 50 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
1178162|NCT00364377|B3|Baseline|Total|Total of all reporting groups
1178163|NCT00364377|B2|Baseline|Placebo|People with impaired fasting glucose treated with placebo once daily.
1178164|NCT00364377|B1|Baseline|Sitagliptin|People with impaired fasting glucose treated with sitagliptin 100mg once daily.
1178165|NCT00364377|P2|Participant Flow|Placebo|People with impaired fasting glucose treated with placebo once daily.
1178166|NCT00364377|P1|Participant Flow|Sitagliptin|People with impaired fasting glucose treated with sitagliptin 100mg once daily.
1178167|NCT00364377|O2|Outcome|Placebo|People with impaired fasting glucose treated with placebo once daily.
1178168|NCT00364377|O1|Outcome|Sitagliptin|People with impaired fasting glucose treated with sitagliptin 100mg once daily.
1178169|NCT00364377|E2|Reported Event|Placebo|People with impaired fasting glucose treated with placebo once daily.
1178170|NCT00364377|E1|Reported Event|Sitagliptin|People with impaired fasting glucose treated with sitagliptin 100mg once daily.
1178171|NCT00364351|B3|Baseline|Total|Total of all reporting groups
1178172|NCT00364351|B2|Baseline|Erlotinib|Erlotinib
1178173|NCT00364351|B1|Baseline|Vandetanib|Vandetanib 300 mg
1178174|NCT00364351|P2|Participant Flow|Erlotinib|Erlotinib 150 mg tablet taken once daily plus a placebo for vandetanib
1178175|NCT00364351|P1|Participant Flow|Vandetanib|Vandetanib 300 mg tablet taken once daily plus a placebo for erlotinib
1178176|NCT00364351|O2|Outcome|Erlotinib|Erlotinib
1178177|NCT00364351|O1|Outcome|Vandetanib|Vandetanib 300 mg
1178178|NCT00364351|O2|Outcome|Erlotinib|Erlotinib
1178179|NCT00364351|O1|Outcome|Vandetanib|Vandetanib 300 mg
1178180|NCT00364351|O2|Outcome|Erlotinib|Erlotinib
1178181|NCT00364351|O1|Outcome|Vandetanib|Vandetanib 300 mg
1178182|NCT00364351|O2|Outcome|Erlotinib|Erlotinib
1178183|NCT00364351|O1|Outcome|Vandetanib|Vandetanib 300 mg
1178184|NCT00364351|O2|Outcome|Erlotinib|Erlotinib
1178185|NCT00364351|O1|Outcome|Vandetanib|Vandetanib 300 mg
1178186|NCT00364351|O2|Outcome|Erlotinib|Erlotinib
1178187|NCT00364351|O1|Outcome|Vandetanib|Vandetanib 300 mg
1178188|NCT00364351|O2|Outcome|Erlotinib|Erlotinib
1178189|NCT00364351|O1|Outcome|Vandetanib|Vandetanib 300 mg
1178190|NCT00364351|E2|Reported Event|Erlotinib|Erlotinib
1178191|NCT00364351|E1|Reported Event|Vandetanib|Vandetanib 300 mg
1178192|NCT00364286|B1|Baseline|Dasatinib|Dasatinib 50mg Orally twice daily.
1178193|NCT00364286|P1|Participant Flow|Dasatinib|Dasatinib 50mg Orally twice daily.
1178194|NCT00364286|O1|Outcome|Dasatinib|Dasatinib 50mg Orally twice daily.
1178195|NCT00364286|E1|Reported Event|Dasatinib|Dasatinib 50mg Orally twice daily.
1178196|NCT00364182|B4|Baseline|Total|Total of all reporting groups
1178197|NCT00364182|B3|Baseline|BeneFIX OD1 Then 50 IU/kg, Then OD2, Then 100 IU/kg|BeneFIX (recombinant coagulation factor IX) on-demand for 16 weeks (OD1), followed by 50 IU/kg BW for 16 weeks prophylactically, followed by 8 weeks BeneFIX on-demand (OD2), followed by 100 IU/kg QW for 16 weeks prophylactically. Dosage form: IV bolus infusion.
1178198|NCT00364182|B2|Baseline|BeneFIX OD1, Then 100 IU/kg, Then OD2, Then 50 IU/kg|BeneFIX (recombinant coagulation factor IX) on-demand for 16 weeks (OD1), followed by 100 international units per kilogram (IU/kg) once per week (QW) for 16 weeks prophylactically, followed by 8 weeks BeneFIX on-demand (OD2), followed by 50 IU/kg twice weekly (BW) for 16 weeks prophylactically. Dosage form: IV bolus infusion.
1178199|NCT00364182|B1|Baseline|Pre-Randomization|Participants were enrolled and received BeneFix (recombinant coagulation factor IX) as intravenous (IV) bolus infusion in the first on-demand (OD1) period but were never randomized.
1186113|NCT00337571|O2|Outcome|Aripiprazole 5 mg|
1178200|NCT00364182|P3|Participant Flow|BeneFIX OD1 Then 50 IU/kg, Then OD2, Then 100 IU/kg|BeneFIX (recombinant coagulation factor IX) on-demand for 16 weeks (OD1), followed by 50 IU/kg BW for 16 weeks prophylactically, followed by 8 weeks BeneFIX on-demand (OD2), followed by 100 IU/kg QW for 16 weeks prophylactically. Dosage form: IV bolus infusion.
1178201|NCT00364182|P2|Participant Flow|BeneFIX OD1, Then 100 IU/kg, Then OD2, Then 50 IU/kg|BeneFIX (recombinant coagulation factor IX) on-demand for 16 weeks (OD1), followed by 100 international units per kilogram (IU/kg) once per week (QW) for 16 weeks prophylactically, followed by 8 weeks BeneFIX on-demand (OD2), followed by 50 IU/kg twice weekly (BW) for 16 weeks prophylactically. Dosage form: IV bolus infusion.
1178202|NCT00364182|P1|Participant Flow|Pre-Randomization|Participants were enrolled and received BeneFix (recombinant coagulation factor IX) as intravenous (IV) bolus infusion in the first on-demand (OD1) period but were never randomized.
1178203|NCT00364182|O3|Outcome|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
1178204|NCT00364182|O2|Outcome|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
1178205|NCT00364182|O1|Outcome|BeneFIX OD1|BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
1178206|NCT00364182|O4|Outcome|BeneFIX OD2|BeneFIX on-demand IV bolus infusion for 8 weeks (third intervention)
1178207|NCT00364182|O3|Outcome|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
1178208|NCT00364182|O2|Outcome|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
1178209|NCT00364182|O1|Outcome|BeneFIX OD1|BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
1178210|NCT00364182|O4|Outcome|BeneFIX OD2|BeneFIX on-demand IV bolus infusion for 8 weeks (third intervention)
1178211|NCT00364182|O3|Outcome|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
1178212|NCT00364182|O2|Outcome|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
1178213|NCT00364182|O1|Outcome|BeneFIX OD1|BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
1178214|NCT00364182|O4|Outcome|BeneFIX OD2|BeneFIX on-demand IV bolus infusion for 8 weeks (third intervention)
1178215|NCT00364182|O3|Outcome|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
1178216|NCT00364182|O2|Outcome|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
1178217|NCT00364182|O1|Outcome|BeneFIX OD1|BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
1178218|NCT00364182|O4|Outcome|BeneFIX OD2|BeneFIX on-demand IV bolus infusion for 8 weeks (third intervention)
1178219|NCT00364182|O3|Outcome|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
1178220|NCT00364182|O2|Outcome|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
1178221|NCT00364182|O1|Outcome|BeneFIX OD1|BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
1178222|NCT00364182|O4|Outcome|BeneFIX OD2|BeneFIX on-demand IV bolus infusion for 8 weeks (third intervention)
1178223|NCT00364182|O3|Outcome|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
1178224|NCT00364182|O2|Outcome|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
1178225|NCT00364182|O1|Outcome|BeneFIX OD1|BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
1178226|NCT00364182|O3|Outcome|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
1178227|NCT00364182|O2|Outcome|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
1178228|NCT00364182|O1|Outcome|BeneFIX OD1|BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
1178229|NCT00364182|E4|Reported Event|BeneFIX OD2|BeneFIX on-demand IV bolus infusion for 8 weeks (third intervention)
1178230|NCT00364182|E3|Reported Event|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
1178231|NCT00364182|E2|Reported Event|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
1178232|NCT00364182|E1|Reported Event|BeneFIX OD1|BeneFIX in an on-demand IV bolus infusion for 16 weeks (first intervention)
1178233|NCT00364156|B3|Baseline|Total|Total of all reporting groups
1178234|NCT00364156|B2|Baseline|Standard Patch Treatment|Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch.
1178235|NCT00364156|B1|Baseline|Extended Patch Treatment|Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions.
1178236|NCT00364156|P2|Participant Flow|Standard Patch Treatment|Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch.
1178237|NCT00364156|P1|Participant Flow|Extended Patch Treatment|Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions.
1178238|NCT00364156|O2|Outcome|Standard Patch Treatment|Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch.
1178239|NCT00364156|O1|Outcome|Extended Patch Treatment|Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions.
1178240|NCT00364156|E2|Reported Event|Standard Patch Treatment|Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch.
1178241|NCT00364156|E1|Reported Event|Extended Patch Treatment|Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions.
1178242|NCT00364130|B3|Baseline|Total|Total of all reporting groups
1178243|NCT00364130|B2|Baseline|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
1178244|NCT00364130|B1|Baseline|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
1178245|NCT00364130|P2|Participant Flow|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
1178246|NCT00364130|P1|Participant Flow|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
1178247|NCT00364130|O2|Outcome|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
1178248|NCT00364130|O1|Outcome|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
1178249|NCT00364130|O2|Outcome|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
1178250|NCT00364130|O1|Outcome|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
1178251|NCT00364130|O2|Outcome|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
1178252|NCT00364130|O1|Outcome|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
1178253|NCT00364130|O2|Outcome|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
1178254|NCT00364130|O1|Outcome|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
1178255|NCT00364130|O2|Outcome|Inactive Low Magnitude Mechanical Stimulus|"Inactive, or placebo low magnitude mechanical stimulus~Placebo (inactive) low magnitude mechanical stimulus: 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device"
1178256|NCT00364130|O1|Outcome|Active Low Magnitude Mechanical Stimulus|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus: 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
1178257|NCT00364130|O2|Outcome|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
1178258|NCT00364130|O1|Outcome|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
1178259|NCT00364130|O2|Outcome|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
1178260|NCT00364130|O1|Outcome|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
1178261|NCT00364130|O2|Outcome|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
1178262|NCT00364130|O1|Outcome|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
1178263|NCT00364130|E2|Reported Event|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
1178264|NCT00364130|E1|Reported Event|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
1178265|NCT00364013|B3|Baseline|Total|Total of all reporting groups
1178266|NCT00364013|B2|Baseline|FOLFOX Alone|Participants were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
1178267|NCT00364013|B1|Baseline|FOLFOX + Panitumumab|Participants were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
1178268|NCT00364013|P2|Participant Flow|FOLFOX Alone|Participants were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
1178269|NCT00364013|P1|Participant Flow|FOLFOX + Panitumumab|Participants were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
1178270|NCT00364013|O2|Outcome|FOLFOX Alone|Participants were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
1178271|NCT00364013|O1|Outcome|FOLFOX + Panitumumab|Participants were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
1178272|NCT00364013|O4|Outcome|Mutant KRAS - FOLFOX|Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
1178273|NCT00364013|O3|Outcome|Mutant KRAS - FOLFOX + Panitumumab|Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
1178274|NCT00364013|O2|Outcome|Wild-type KRAS - FOLFOX|Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
1178275|NCT00364013|O1|Outcome|Wild-type KRAS - FOLFOX + Panitumumab|Participants with wild-type KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
1178276|NCT00364013|O4|Outcome|Mutant KRAS - FOLFOX|Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
1178277|NCT00364013|O3|Outcome|Mutant KRAS - FOLFOX + Panitumumab|Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
1178278|NCT00364013|O2|Outcome|Wild-type KRAS - FOLFOX|Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
1178279|NCT00364013|O1|Outcome|Wild-type KRAS - FOLFOX + Panitumumab|Participants with wild-type KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
1178319|NCT00363805|P3|Participant Flow|Placebo|Patients receive placebo beverage and placebo capsules daily for 6 months.
1186114|NCT00337571|O1|Outcome|Placebo|
1178280|NCT00364013|O4|Outcome|Mutant KRAS - FOLFOX|Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
1178281|NCT00364013|O3|Outcome|Mutant KRAS - FOLFOX + Panitumumab|Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
1178282|NCT00364013|O2|Outcome|Wild-type KRAS - FOLFOX|Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
1178283|NCT00364013|O1|Outcome|Wild-type KRAS - FOLFOX + Panitumumab|Participants with wild-type KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
1178284|NCT00364013|O4|Outcome|Mutant KRAS - FOLFOX|Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
1178285|NCT00364013|O3|Outcome|Mutant KRAS - FOLFOX + Panitumumab|Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
1178286|NCT00364013|O2|Outcome|Wild-type KRAS - FOLFOX|Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
1178287|NCT00364013|O1|Outcome|Wild-type KRAS - FOLFOX + Panitumumab|Participants with wild-type KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
1178398|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
1178288|NCT00364013|O4|Outcome|Mutant KRAS - FOLFOX|Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
1178289|NCT00364013|O3|Outcome|Mutant KRAS - FOLFOX + Panitumumab|Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
1178290|NCT00364013|O2|Outcome|Wild-type KRAS - FOLFOX|Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
1178291|NCT00364013|O1|Outcome|Wild-type KRAS - FOLFOX + Panitumumab|Participants with wild-type KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
1178292|NCT00364013|E2|Reported Event|FOLFOX Alone|Participants received FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
1178293|NCT00364013|E1|Reported Event|Panitumumab Plus FOLFOX|Participants received panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
1178294|NCT00363896|B3|Baseline|Total|Total of all reporting groups
1178295|NCT00363896|B2|Baseline|Placebo|Placebo by inhalation
1178296|NCT00363896|B1|Baseline|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
1178297|NCT00363896|P2|Participant Flow|Placebo|Placebo by inhalation
1178298|NCT00363896|P1|Participant Flow|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
1178299|NCT00363896|O2|Outcome|Placebo|Placebo once-daily via inhalation
1178300|NCT00363896|O1|Outcome|Aclidinium 200 μg Once-daily|Aclidinium bromide 200 μg once-daily via inhalation
1178301|NCT00363896|O2|Outcome|Placebo|Placebo by inhalation
1178302|NCT00363896|O1|Outcome|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
1178303|NCT00363896|O2|Outcome|Placebo|Placebo once-daily via inhalation
1178304|NCT00363896|O1|Outcome|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily via inhalation
1178305|NCT00363896|O2|Outcome|Placebo|Placebo once-daily via inhalation
1178306|NCT00363896|O1|Outcome|Aclidinium 200 μg Once-daily|Aclidinium bromide 200 μg once-daily via inhalation
1178307|NCT00363896|E2|Reported Event|Placebo|Placebo by inhalation
1178308|NCT00363896|E1|Reported Event|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
1178309|NCT00363883|B1|Baseline|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
1178310|NCT00363883|P1|Participant Flow|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
1178311|NCT00363883|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
1178312|NCT00363883|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
1178313|NCT00363883|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
1178314|NCT00363883|E1|Reported Event|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
1178315|NCT00363805|B4|Baseline|Total|Total of all reporting groups
1178316|NCT00363805|B3|Baseline|Placebo|Patients receive placebo beverage and placebo capsules daily for 6 months.
1178317|NCT00363805|B2|Baseline|Polyphenon E|Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.
1178318|NCT00363805|B1|Baseline|Green Tea|Patients receive green tea beverage and placebo capsules for 6 months.
1178320|NCT00363805|P2|Participant Flow|Polyphenon E|Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.
1178321|NCT00363805|P1|Participant Flow|Green Tea|Patients receive green tea beverage and placebo capsules for 6 months.
1178322|NCT00363805|O3|Outcome|Placebo|Patients receive placebo beverage and placebo capsules daily for 6 months.
1178323|NCT00363805|O2|Outcome|Polyphenon E|Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.
1178324|NCT00363805|O1|Outcome|Green Tea|Patients receive green tea beverage and placebo capsules for 6 months.
1178325|NCT00363805|O3|Outcome|Placebo|Patients receive placebo beverage and placebo capsules daily for 6 months.
1178326|NCT00363805|O2|Outcome|Polyphenon E|Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.
1178327|NCT00363805|O1|Outcome|Green Tea|Patients receive green tea beverage and placebo capsules for 6 months.
1178328|NCT00363805|E3|Reported Event|Placebo|Patients receive placebo beverage and placebo capsules daily for 6 months.
1178329|NCT00363805|E2|Reported Event|Polyphenon E|Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.
1178330|NCT00363805|E1|Reported Event|Green Tea|Patients receive green tea beverage and placebo capsules for 6 months.
1178331|NCT00363779|B1|Baseline|LGL Patients Administered Cyclosporine|Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
1178399|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
1178332|NCT00363779|P1|Participant Flow|LGL Patients Administered Cyclosporine|Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
1178333|NCT00363779|O1|Outcome|LGL Patients Administered Cyclosporine|Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
1178334|NCT00363779|O1|Outcome|LGL Patients Administered Cyclosporine|Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
1178335|NCT00363779|E1|Reported Event|LGL Patients Administered Cyclosporine|Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
1178336|NCT00363675|B1|Baseline|All Study Participants|Children were administered hand assessments to measure function after hand burns by a trained therapist.
1178337|NCT00363675|P1|Participant Flow|All Study Participants|Children were administered hand assessments to measure function after hand burns by a trained therapist.
1178338|NCT00363675|O1|Outcome|All Study Participants|Children were administered hand assessments to measure function after hand burns by a trained therapist.
1178339|NCT00363675|O1|Outcome|All Study Participants|Children were administered hand assessments to measure function after hand burns by a trained therapist.
1178340|NCT00363675|O1|Outcome|Normal as Defined by Hand Therapist.|Children were administered hand assessments to measure function after hand burns by a trained therapist.
1178341|NCT00363675|O1|Outcome|All Study Participants|Children were administered hand assessments to measure function after hand burns by a trained therapist.
1178342|NCT00363675|E1|Reported Event|All Study Participants|Children were administered hand assessments to measure function after hand burns by a trained therapist.
1178343|NCT00363545|B3|Baseline|Total|Total of all reporting groups
1178344|NCT00363545|B2|Baseline|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
1178345|NCT00363545|B1|Baseline|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
1178346|NCT00363545|P2|Participant Flow|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
1178347|NCT00363545|P1|Participant Flow|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
1178348|NCT00363545|O2|Outcome|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
1178349|NCT00363545|O1|Outcome|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
1178350|NCT00363545|O2|Outcome|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
1178351|NCT00363545|O1|Outcome|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
1178352|NCT00363545|O2|Outcome|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
1178353|NCT00363545|O1|Outcome|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
1178437|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
1178354|NCT00363545|O2|Outcome|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
1178355|NCT00363545|O1|Outcome|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
1178356|NCT00363545|O2|Outcome|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
1178357|NCT00363545|O1|Outcome|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
1178358|NCT00363545|O2|Outcome|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
1178359|NCT00363545|O1|Outcome|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
1178360|NCT00363545|O2|Outcome|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
1187649|NCT00330460|O1|Outcome|Alendronate 70 mg QW|
1178361|NCT00363545|O1|Outcome|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
1178362|NCT00363545|E2|Reported Event|Lyophilized Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
1178363|NCT00363545|E1|Reported Event|Liquid Rotarix Group|Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
1178364|NCT00363467|B1|Baseline|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
1178365|NCT00363467|P1|Participant Flow|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
1178366|NCT00363467|O1|Outcome|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
1178367|NCT00363467|O1|Outcome|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
1178368|NCT00363467|O1|Outcome|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
1178369|NCT00363467|O1|Outcome|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
1178370|NCT00363467|O1|Outcome|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
1178371|NCT00363467|E1|Reported Event|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
1178372|NCT00363415|B3|Baseline|Total|Total of all reporting groups
1178373|NCT00363415|B2|Baseline|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
1178374|NCT00363415|B1|Baseline|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
1178375|NCT00363415|P2|Participant Flow|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
1178376|NCT00363415|P1|Participant Flow|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
1178377|NCT00363415|O2|Outcome|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
1178378|NCT00363415|O1|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
1178379|NCT00363415|O2|Outcome|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
1178380|NCT00363415|O1|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
1178381|NCT00363415|O2|Outcome|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
1178382|NCT00363415|O1|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
1178383|NCT00363415|O2|Outcome|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
1178384|NCT00363415|O1|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
1178385|NCT00363415|O2|Outcome|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
1178386|NCT00363415|O1|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
1178387|NCT00363415|O2|Outcome|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
1178438|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
1178388|NCT00363415|O1|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
1178389|NCT00363415|E2|Reported Event|Etoposide + Carboplatin|"Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.~(Participants who received at least one dose of study drug)"
1178390|NCT00363415|E1|Reported Event|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles (Participants who received at least one dose of study drug)
1178391|NCT00363311|B3|Baseline|Total|Total of all reporting groups
1178392|NCT00363311|B2|Baseline|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
1178393|NCT00363311|B1|Baseline|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
1178394|NCT00363311|P2|Participant Flow|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
1178395|NCT00363311|P1|Participant Flow|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 milligrams (mg) administered orally once daily for 156 weeks
1178396|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
1178397|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
1187650|NCT00330460|O2|Outcome|Denosumab 60 mg Q6M|
1178400|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
1178401|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
1178402|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
1178403|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
1178404|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
1178405|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
1178406|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
1178407|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
1178408|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
1178409|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
1178410|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
1178411|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
1178412|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
1178413|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
1178414|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
1178415|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
1178416|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
1178417|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
1178418|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
1178419|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
1178420|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
1178421|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
1178422|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
1178423|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
1178424|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
1178425|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
1178426|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
1178427|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
1178428|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
1178429|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
1178430|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
1178431|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
1178432|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
1178433|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
1178434|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
1178435|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
1178436|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
1178439|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
1178440|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
1178441|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
1178442|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
1178443|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
1178444|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
1178445|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
1178446|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
1178447|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
1178448|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
1178449|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
1178450|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
1178451|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
1178452|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
1178453|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
1178454|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
1178455|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
1178456|NCT00363311|E2|Reported Event|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
1178457|NCT00363311|E1|Reported Event|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
1178458|NCT00363298|B3|Baseline|Total|Total of all reporting groups
1178459|NCT00363298|B2|Baseline|Caffeine Pills|Caffeine in capsules identical to those containing d-amphetamine, with 200 mg of caffeine in Bottle A capsules, and 100 mg of caffeine in Bottle B capsules. Dose was 1 capsule from Bottle A and 1 capsule from Bottle B each morning. Frequency: once daily. Duration: 5 weeks
1178460|NCT00363298|B1|Baseline|D-amphetamine|"Dextro-amphetamine: dextro-amphetamine dosage form: 15 mg capsules, in Bottles A and B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks.~Caffeine dosage form: 200 mg capsules in Bottle A, 100 mg capsules in Bottle B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks."
1178461|NCT00363298|P2|Participant Flow|Caffeine Pills|Caffeine in capsules identical to those containing d-amphetamine, with 200 mg of caffeine in Bottle A capsules, and 100 mg of caffeine in Bottle B capsules. Dose was 1 capsule from Bottle A and 1 capsule from Bottle B each morning. Frequency: once daily. Duration: 5 weeks
1178462|NCT00363298|P1|Participant Flow|D-amphetamine|"Dextro-amphetamine dosage form: 15 mg capsules, in Bottles A and B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks.~Caffeine dosage form: 200 mg capsules in Bottle A, 100 mg capsules in Bottle B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks."
1178463|NCT00363298|O2|Outcome|Caffeine Pills|Caffeine in capsules identical to those containing d-amphetamine, with 200 mg of caffeine in Bottle A capsules, and 100 mg of caffeine in Bottle B capsules. Dose was 1 capsule from Bottle A and 1 capsule from Bottle B each morning. Frequency: once daily. Duration: 5 weeks
1178464|NCT00363298|O1|Outcome|D-amphetamine|"Dextro-amphetamine: dextro-amphetamine dosage form: 15 mg capsules, in Bottles A and B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks.~Caffeine dosage form: 200 mg capsules in Bottle A, 100 mg capsules in Bottle B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks."
1178465|NCT00363298|O2|Outcome|Caffeine Pills|Caffeine in capsules identical to those containing d-amphetamine, with 200 mg of caffeine in Bottle A capsules, and 100 mg of caffeine in Bottle B capsules. Dose was 1 capsule from Bottle A and 1 capsule from Bottle B each morning. Frequency: once daily. Duration: 5 weeks
1178466|NCT00363298|O1|Outcome|D-amphetamine|"Dextro-amphetamine dosage form: 15 mg capsules, in Bottles A and B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks.~Caffeine dosage form: 200 mg capsules in Bottle A, 100 mg capsules in Bottle B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks."
1178467|NCT00363298|E2|Reported Event|Caffeine Pills|Caffeine in capsules identical to those containing d-amphetamine, with 200 mg of caffeine in Bottle A capsules, and 100 mg of caffeine in Bottle B capsules. Dose was 1 capsule from Bottle A and 1 capsule from Bottle B each morning. Frequency: once daily. Duration: 5 weeks
1178468|NCT00363298|E1|Reported Event|D-amphetamine|Dextro-amphetamine dosage form: 15 mg capsules, in Bottles A and B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks.
1178469|NCT00363246|B1|Baseline|Group 1|Older veterans who use a wheelchair for their primary means of mobility.
1178470|NCT00363246|P1|Participant Flow|Group 1|Older veterans who use a wheelchair for their primary means of mobility.
1178471|NCT00363246|O1|Outcome|Wheelchair-using Veterans|Older Veterans who use a wheelchair for their primary means of mobility. 1 year follow-up period.
1178472|NCT00363246|O1|Outcome|Wheelchair-using Veterans|Older veterans who use a wheelchair for their primary means of mobility. 1 year follow-up period.
1178473|NCT00363246|E1|Reported Event|Elderly Veterans Using Wheelchairs for Mobility|Older veterans who use a wheelchair for their primary means of mobility. This was an observational study. There was no intervention and thus no adverse events were collected as part of the study. Sometimes we learned of a death from a relative when we called monthly.
1178479|NCT00363168|O2|Outcome|Ranibizumab Dose B|0.5 mg/0.05 ml intravitreal injection
1178480|NCT00363168|O1|Outcome|Ranibizumab Dose A|0.3 mg/0.05 ml intravitreal injection
1178481|NCT00363168|O2|Outcome|Ranibizumab Dose B|0.5 mg/0.05 ml intravitreal injection
1178482|NCT00363168|O1|Outcome|Ranibizumab Dose A|0.3 mg/0.05 ml intravitreal injection
1178483|NCT00363168|E2|Reported Event|Ranibizumab Dose B|0.5 mg/0.05 ml intravitreal injection
1178484|NCT00363168|E1|Reported Event|Ranibizumab Dose A|0.3 mg/0.05 ml intravitreal injection
1178485|NCT00363142|B3|Baseline|Total|Total of all reporting groups
1178486|NCT00363142|B2|Baseline|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
1178487|NCT00363142|B1|Baseline|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
1178488|NCT00363142|P2|Participant Flow|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
1178489|NCT00363142|P1|Participant Flow|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
1178490|NCT00363142|O3|Outcome|FPV/RTV 700/100 mg BID|Twice daily FPV regimen boosted with a reduced dose of RTV 100 mg
1178491|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700/100mg twice a day [BID] or 1400/200mg QD)
1178492|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400/100mg once a day (QD)
1178493|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
1178494|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
1178495|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
1178496|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
1178497|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
1178498|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
1178499|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
1178500|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
1178501|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
1178502|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
1178503|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
1178504|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
1178505|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
1178506|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
1178507|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
1178508|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
1178509|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
1178510|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
1178511|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
1178512|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
1178513|NCT00363142|E2|Reported Event|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
1178514|NCT00363142|E1|Reported Event|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
1178515|NCT00363129|B3|Baseline|Total|Total of all reporting groups
1178516|NCT00363129|B2|Baseline|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
1178517|NCT00363129|B1|Baseline|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
1178518|NCT00363129|P2|Participant Flow|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
1178519|NCT00363129|P1|Participant Flow|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
1178520|NCT00363129|O2|Outcome|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
1178521|NCT00363129|O1|Outcome|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
1178522|NCT00363129|O2|Outcome|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
1178523|NCT00363129|O1|Outcome|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
1178524|NCT00363129|O2|Outcome|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
1178525|NCT00363129|O1|Outcome|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
1178526|NCT00363129|O2|Outcome|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
1178527|NCT00363129|O1|Outcome|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
1178528|NCT00363129|O2|Outcome|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
1178529|NCT00363129|O1|Outcome|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
1178530|NCT00363129|E2|Reported Event|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
1178531|NCT00363129|E1|Reported Event|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
1178532|NCT00363077|B3|Baseline|Total|Total of all reporting groups
1178533|NCT00363077|B2|Baseline|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1178534|NCT00363077|B1|Baseline|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1178535|NCT00363077|P2|Participant Flow|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1178536|NCT00363077|P1|Participant Flow|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1178537|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1178538|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1178539|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1178540|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1178541|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1178542|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1178543|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1178544|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1178545|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1178546|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1178547|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1178548|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1178549|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1178550|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1178551|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1178552|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1178553|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1178554|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1178555|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1178556|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1178557|NCT00363077|E2|Reported Event|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1178558|NCT00363077|E1|Reported Event|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1178559|NCT00363051|B3|Baseline|Total|Total of all reporting groups
1178560|NCT00363051|B2|Baseline|Stratum 2: Everolimus 10 mg + Octreotide Depot|Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.
1178561|NCT00363051|B1|Baseline|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
1178562|NCT00363051|P2|Participant Flow|Stratum 2: Everolimus 10 mg + Octreotide Depot|"Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.~Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day."
1178563|NCT00363051|P1|Participant Flow|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
1178564|NCT00363051|O1|Outcome|Stratum 2: Everolimus 10 mg + Octreotide Depot|"Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.~Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day."
1178565|NCT00363051|O2|Outcome|Stratum 2: Everolimus 10 mg + Octreotide Depot|"Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.~Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day."
1178566|NCT00363051|O1|Outcome|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
1178567|NCT00363051|O1|Outcome|Stratum 2: Everolimus 10 mg + Octreotide Depot|"Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.~Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day."
1178568|NCT00363051|O1|Outcome|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
1178569|NCT00363051|O1|Outcome|Stratum 2: Everolimus 10 mg + Octreotide Depot|Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.
1178570|NCT00363051|O1|Outcome|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
1178571|NCT00363051|O1|Outcome|Stratum 2: Everolimus 10 mg + Octreotide Depot|Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.
1178572|NCT00363051|O1|Outcome|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
1178573|NCT00363051|O1|Outcome|Stratum 2: Everolimus 10 mg + Octreotide Depot|"Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.~Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day."
1178574|NCT00363051|O1|Outcome|Stratum 2: Everolimus 10 mg + Octreotide Depot|"Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.~Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day."
1178575|NCT00363051|O1|Outcome|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
1178576|NCT00363051|O1|Outcome|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
1178700|NCT00362440|B2|Baseline|Pioglitazone or Metformin|"Diabetes treatment therapy~Pioglitazone+placebo"
1178577|NCT00363051|E2|Reported Event|Stratum 2: Everolimus 10 mg + Octreotide Depot|Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.
1178578|NCT00363051|E1|Reported Event|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
1178579|NCT00363038|B1|Baseline|Average Bruise Improvement|pulsed dye laser induced four 1 cm bruises at least 5 cm apart on the skin of the upper arm (two bruises on each arm). Subjects applied different topical ointments on each of their bruises twice a day. Ointments were: 5% vitamin K cream; 1% vitamin K and 0.3% retinol cream; 20% topical arnica; white petrolatum USP as placebo.
1178580|NCT00363038|P1|Participant Flow|Average Bruise Improvement|pulsed dye laser induced four 1 cm bruises at least 5 cm apart on the skin of the upper arm (two bruises on each arm). Subjects applied different topical ointments on each of their bruises twice a day. Ointments were: 5% vitamin K cream; 1% vitamin K and 0.3% retinol cream; 20% topical arnica; white petrolatum United States Pharmacopeia (USP) as placebo.
1178581|NCT00363038|O1|Outcome|Average Bruise Improvement|pulsed dye laser induced four 1 cm bruises at least 5 cm apart on the skin of the upper arm (two bruises on each arm). Subjects applied different topical ointments on each of their bruises twice a day. Ointments were: 5% vitamin K cream; 1% vitamin K and 0.3% retinol cream; 20% topical arnica; white petrolatum USP as placebo.
1178675|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
1178582|NCT00363038|E1|Reported Event|Average Bruise Improvement|pulsed dye laser induced four 1 cm bruises at least 5 cm apart on the skin of the upper arm (two bruises on each arm). Subjects applied different topical ointments on each of their bruises twice a day. Ointments were: 5% vitamin K cream; 1% vitamin K and 0.3% retinol cream; 20% topical arnica; white petrolatum USP as placebo.
1178583|NCT00362882|B3|Baseline|Total|Total of all reporting groups
1178584|NCT00362882|B2|Baseline|Arm 2|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
1178585|NCT00362882|B1|Baseline|Arm 1|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
1178586|NCT00362882|P2|Participant Flow|Arm 2|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
1178587|NCT00362882|P1|Participant Flow|Arm 1|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
1178588|NCT00362882|O2|Outcome|Arm 2|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
1178589|NCT00362882|O1|Outcome|Arm 1|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
1178590|NCT00362882|O2|Outcome|Arm 2|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
1178591|NCT00362882|O1|Outcome|Arm 1|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
1178592|NCT00362882|O2|Outcome|Arm 2|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
1178593|NCT00362882|O1|Outcome|Arm 1|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
1178594|NCT00362882|E2|Reported Event|Arm 2|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
1178595|NCT00362882|E1|Reported Event|Arm 1|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
1178596|NCT00362817|B1|Baseline|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin~temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.~carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
1178701|NCT00362440|B1|Baseline|Leptin|"Leptin replacement therapy~Leptin+pioglitazone"
1178704|NCT00362440|O2|Outcome|Pioglitazone or Metformin|"Diabetes treatment therapy~Pioglitazone+placebo"
1178597|NCT00362817|P1|Participant Flow|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin~temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.~carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
1178598|NCT00362817|O1|Outcome|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin~temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.~carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
1178599|NCT00362817|O1|Outcome|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin~temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.~carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
1178600|NCT00362817|O1|Outcome|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin~temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.~carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
1178625|NCT00362648|E3|Reported Event|RotaTeq™, Placebo, RotaTeq™|"Includes SAE data for subjects who were cross-treated, ie; received a treatment other than what they were assigned.~Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days following any vaccination."
1178601|NCT00362817|O1|Outcome|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin~carboplatin: IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2.~temozolomide: 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks."
1178602|NCT00362817|O1|Outcome|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin~temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.~carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
1178603|NCT00362817|O1|Outcome|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin~temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.~carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
1178604|NCT00362817|E1|Reported Event|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin~temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.~carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
1178605|NCT00362648|B5|Baseline|Total|Total of all reporting groups
1178606|NCT00362648|B4|Baseline|Placebo - Asia|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
1178607|NCT00362648|B3|Baseline|RotaTeq™ - Asia|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
1178608|NCT00362648|B2|Baseline|Placebo - Africa|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
1178609|NCT00362648|B1|Baseline|RotaTeq™ - Africa|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
1178610|NCT00362648|P4|Participant Flow|Placebo - Asia|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
1178611|NCT00362648|P3|Participant Flow|RotaTeq™ - Asia|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
1178612|NCT00362648|P2|Participant Flow|Placebo - Africa|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
1178613|NCT00362648|P1|Participant Flow|RotaTeq™ - Africa|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
1178614|NCT00362648|O2|Outcome|Placebo - Asia|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
1178615|NCT00362648|O1|Outcome|RotaTeq™ - Asia|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
1178616|NCT00362648|O2|Outcome|Placebo - Africa|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
1178617|NCT00362648|O1|Outcome|RotaTeq™ - Africa|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
1178618|NCT00362648|O4|Outcome|Placebo - Asia|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
1178619|NCT00362648|O3|Outcome|RotaTeq™ - Asia|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
1178702|NCT00362440|P2|Participant Flow|Pioglitazone or Metformin|"Diabetes treatment therapy~Pioglitazone+placebo"
1178620|NCT00362648|O2|Outcome|Placebo - Africa|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
1178621|NCT00362648|O1|Outcome|RotaTeq™ - Africa|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
1178622|NCT00362648|E6|Reported Event|Placebo - Kenya Safety Cohort|A subset of subjects (Kenya Safety Cohort, N=301), were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
1178623|NCT00362648|E5|Reported Event|RotaTeq™ - Kenya Safety Cohort|A subset of subjects (Kenya Safety Cohort, N=301), were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
1178624|NCT00362648|E4|Reported Event|Placebo, Placebo, RotaTeq™|"Includes SAE data for subjects who were cross-treated, ie; received a treatment other than what they were assigned.~Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days following any vaccination."
1178674|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
1178626|NCT00362648|E2|Reported Event|Placebo|"Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.~SAEs were recorded for all randomized subjects for 14 days following any vaccination and are reported by treatment group (including cross treated subjects) and are not reported by Region (Africa and Asia).~Other Adverse Events were recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all non-serious and serious adverse experiences occurring within 42 days following any vaccination."
1178627|NCT00362648|E1|Reported Event|RotaTeq™|"Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.~Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days following any vaccination and are reported by treatment group (including cross treated subjects) and are not reported by Region (Africa and Asia).~Other Adverse Events were recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all non-serious and serious adverse experiences occurring within 42 days following any vaccination."
1178628|NCT00362609|B3|Baseline|Total|Total of all reporting groups
1178629|NCT00362609|B2|Baseline|2.5 mg Pantoprazole|2.5 mg of pantoprazole granules daily for at least 5 days. This dose corresponds to approximately 1.2 mg/kg
1178630|NCT00362609|B1|Baseline|1.25 mg Pantoprazole|1.25 mg of pantoprazole granules daily for at least 5 days. This dosing corresponds to approximately 0.6 mg/kg
1178631|NCT00362609|P2|Participant Flow|2.5 mg Pantoprazole|2.5 mg of pantoprazole granules daily for at least 5 days. This dose corresponds to approximately 1.2 mg/kg
1178632|NCT00362609|P1|Participant Flow|1.25 mg Pantoprazole|1.25 mg of pantoprazole granules daily for at least 5 days. This dosing corresponds to approximately 0.6 mg/kg
1178633|NCT00362609|O2|Outcome|2.5 mg Pantoprazole|2.5 mg of pantoprazole granules daily for at least 5 days. This dose corresponds to approximately 1.2 mg/kg
1178634|NCT00362609|O1|Outcome|1.25 mg Pantoprazole|1.25 mg of pantoprazole granules daily for at least 5 days. This dosing corresponds to approximately 0.6 mg/kg
1178635|NCT00362609|O2|Outcome|2.5 mg Pantoprazole|2.5 mg of pantoprazole granules daily for at least 5 days. This dose corresponds to approximately 1.2 mg/kg
1178636|NCT00362609|O1|Outcome|1.25 mg Pantoprazole|1.25 mg of pantoprazole granules daily for at least 5 days. This dosing corresponds to approximately 0.6 mg/kg
1178637|NCT00362609|O2|Outcome|2.5 mg Pantoprazole|2.5 mg of pantoprazole granules daily for at least 5 days. This dose corresponds to approximately 1.2 mg/kg
1178638|NCT00362609|O1|Outcome|1.25 mg Pantoprazole|1.25 mg of pantoprazole granules daily for at least 5 days. This dosing corresponds to approximately 0.6 mg/kg
1178639|NCT00362609|O2|Outcome|2.5 mg Pantoprazole|2.5 mg of pantoprazole granules daily for at least 5 days. This dose corresponds to approximately 1.2 mg/kg
1178640|NCT00362609|O1|Outcome|1.25 mg Pantoprazole|1.25 mg of pantoprazole granules daily for at least 5 days. This dosing corresponds to approximately 0.6 mg/kg
1178641|NCT00362609|E2|Reported Event|2.5 mg Pantoprazole|2.5 mg of pantoprazole granules daily for at least 5 days. This dose corresponds to approximately 1.2 mg/kg
1178642|NCT00362609|E1|Reported Event|1.25 mg Pantoprazole|1.25 mg of pantoprazole granules daily for at least 5 days. This dosing corresponds to approximately 0.6 mg/kg
1178643|NCT00362466|B3|Baseline|Total|Total of all reporting groups
1178644|NCT00362466|B2|Baseline|Imatinib|600 mg QD
1178645|NCT00362466|B1|Baseline|Dasatinib|100 mg QD
1178646|NCT00362466|P2|Participant Flow|Imatinib|600 mg QD
1178647|NCT00362466|P1|Participant Flow|Dasatinib|100 mg once daily (QD)
1178648|NCT00362466|O2|Outcome|Imatinib|600 mg QD
1178649|NCT00362466|O1|Outcome|Dasatinib|100 mg QD
1178650|NCT00362466|O2|Outcome|Imatinib|600 mg QD
1178651|NCT00362466|O1|Outcome|Dasatinib|100 mg QD
1178652|NCT00362466|O2|Outcome|Imatinib|600 mg QD
1178653|NCT00362466|O1|Outcome|Dasatinib|100 mg QD
1178654|NCT00362466|O2|Outcome|Imatinib|600 mg QD
1178655|NCT00362466|O1|Outcome|Dasatinib|100 mg QD
1178656|NCT00362466|O2|Outcome|Imatinib|600 mg QD
1178657|NCT00362466|O1|Outcome|Dasatinib|100 mg QD
1178658|NCT00362466|O2|Outcome|Imatinib|600 mg QD
1178659|NCT00362466|O1|Outcome|Dasatinib|100 mg QD
1178660|NCT00362466|O2|Outcome|Imatinib|600 mg QD
1178661|NCT00362466|O1|Outcome|Dasatinib|100 mg QD
1178662|NCT00362466|O2|Outcome|Imatinib|600 mg QD
1178663|NCT00362466|O1|Outcome|Dasatinib|100 mg QD
1178664|NCT00362466|E2|Reported Event|Imatinib|600 mg QD
1178665|NCT00362466|E1|Reported Event|Dasatinib|100 mg once daily (QD)
1178666|NCT00362453|B3|Baseline|Total|Total of all reporting groups
1178703|NCT00362440|P1|Participant Flow|Leptin|"Leptin replacement therapy~Leptin+pioglitazone"
1178667|NCT00362453|B2|Baseline|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
1178668|NCT00362453|B1|Baseline|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
1178669|NCT00362453|P2|Participant Flow|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
1178670|NCT00362453|P1|Participant Flow|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
1178671|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
1178672|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
1178673|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
1178676|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
1178677|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
1178678|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
1178679|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
1178680|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
1178681|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
1178682|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
1178683|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
1178684|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
1178685|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
1178686|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
1178687|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
1178688|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
1178689|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
1178690|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
1178691|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
1178692|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
1178693|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
1178694|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
1178695|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
1178696|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
1178697|NCT00362453|E2|Reported Event|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
1178698|NCT00362453|E1|Reported Event|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
1178699|NCT00362440|B3|Baseline|Total|Total of all reporting groups
1178787|NCT00362297|B3|Baseline|Total|Total of all reporting groups
1178705|NCT00362440|O1|Outcome|Leptin|"Leptin replacement therapy~Leptin+pioglitazone"
1178706|NCT00362440|O2|Outcome|Pioglitazone or Metformin|"Diabetes treatment therapy~Pioglitazone+placebo"
1178707|NCT00362440|O1|Outcome|Leptin|"Leptin replacement therapy~Leptin+pioglitazone"
1178708|NCT00362440|O2|Outcome|Pioglitazone or Metformin|"Diabetes treatment therapy~Pioglitazone+placebo"
1178709|NCT00362440|O1|Outcome|Leptin|"Leptin replacement therapy~Leptin+pioglitazone"
1178710|NCT00362440|E2|Reported Event|Pioglitazone or Metformin|"Diabetes treatment therapy~Pioglitazone+placebo"
1178711|NCT00362440|E1|Reported Event|Leptin|"Leptin replacement therapy~Leptin+pioglitazone"
1178712|NCT00362414|B1|Baseline|Beta-hCG + Erythropoietin|Subjects received a 9-day course of beta-human chorionic gonadotropin (once daily on Days 1, 3, and 5 of study participation) followed by erythropoietin (once daily on Days 7, 8, and 9 of study participation)
1178713|NCT00362414|P1|Participant Flow|Beta-hCG + Erythropoietin|Subjects received a 9-day course of beta-human chorionic gonadotropin (once daily on Days 1, 3, and 5 of study participation) followed by erythropoietin (once daily on Days 7, 8, and 9 of study participation)
1178714|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
1178715|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
1178716|NCT00362414|O1|Outcome|Beta-hCG + Erythropoietin|Subjects received a 9-day course of beta-human chorionic gonadotropin (once daily on Days 1, 3, and 5 of study participation) followed by erythropoietin (once daily on Days 7, 8, and 9 of study participation)
1178717|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
1178718|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
1178719|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
1178726|NCT00362414|O1|Outcome|Dual Growth Factor|"All patients received erythropoietin and beta-hCG. This was the only treatment arm in the study, i.e., all enrollees received active therapy.~Dual Growth Factor: 10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation~30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation"
1178727|NCT00362414|O1|Outcome|Dual Growth Factor|"All patients received erythropoietin and beta-hCG. This was the only treatment arm in the study, i.e., all enrollees received active therapy.~Dual Growth Factor: 10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation~30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation"
1178728|NCT00362414|E1|Reported Event|Beta-hCG + Erythropoietin|Subjects received a 9-day course of beta-human chorionic gonadotropin (once daily on Days 1, 3, and 5 of study participation) followed by erythropoietin (once daily on Days 7, 8, and 9 of study participation)
1178729|NCT00362401|B4|Baseline|Total|Total of all reporting groups
1178730|NCT00362401|B3|Baseline|St Jude Medical|patients with a St Jude Medical mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
1178731|NCT00362401|B2|Baseline|Medtronic Hall|patients with a Medtronic Hall mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
1178732|NCT00362401|B1|Baseline|ATS (Open Pivot® Standard)|patients with an ATS mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
1178733|NCT00362401|P3|Participant Flow|St Jude Medical|patients with a St Jude Medical mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
1178734|NCT00362401|P2|Participant Flow|Medtronic Hall|patients with a Medtronic Hall mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
1178735|NCT00362401|P1|Participant Flow|ATS (Open Pivot® Standard)|patients with an ATS mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
1178736|NCT00362401|O3|Outcome|Group 3 - St Jude Medical|patients with a St Jude Medical mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
1178737|NCT00362401|O2|Outcome|Group 2- Medtronic Hall|patients with a Medtronic Hall mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
1178738|NCT00362401|O1|Outcome|Group 1 - ATS|patients with an ATS mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
1178739|NCT00362375|B3|Baseline|Total|Total of all reporting groups
1178740|NCT00362375|B2|Baseline|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
1178741|NCT00362375|B1|Baseline|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
1178742|NCT00362375|P2|Participant Flow|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
1178743|NCT00362375|P1|Participant Flow|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
1178744|NCT00362375|O2|Outcome|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
1178745|NCT00362375|O1|Outcome|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
1178746|NCT00362375|O2|Outcome|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
1178747|NCT00362375|O1|Outcome|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
1178748|NCT00362375|O2|Outcome|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
1187651|NCT00330460|O1|Outcome|Alendronate 70 mg QW|
1178749|NCT00362375|O1|Outcome|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
1178750|NCT00362375|O2|Outcome|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
1178751|NCT00362375|O1|Outcome|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
1178752|NCT00362375|O2|Outcome|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
1178753|NCT00362375|O1|Outcome|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
1178754|NCT00362375|E2|Reported Event|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
1178755|NCT00362375|E1|Reported Event|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
1178756|NCT00362336|B4|Baseline|Total|Total of all reporting groups
1178757|NCT00362336|B3|Baseline|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
1178758|NCT00362336|B2|Baseline|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
1178759|NCT00362336|B1|Baseline|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
1178788|NCT00362297|B2|Baseline|High-dose|
1178789|NCT00362297|B1|Baseline|Standard Dose|
1178790|NCT00362297|P2|Participant Flow|High-dose|
1178760|NCT00362336|P3|Participant Flow|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
1178761|NCT00362336|P2|Participant Flow|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
1178762|NCT00362336|P1|Participant Flow|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
1178763|NCT00362336|O3|Outcome|DTaP-IPV-Hep B-PRP-T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
1178940|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1187652|NCT00330460|E2|Reported Event|Denosumab 60 mg Q6M|
1178764|NCT00362336|O2|Outcome|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
1178765|NCT00362336|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
1178766|NCT00362336|O3|Outcome|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
1178767|NCT00362336|O2|Outcome|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
1178768|NCT00362336|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
1178769|NCT00362336|O3|Outcome|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
1178770|NCT00362336|O2|Outcome|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
1178771|NCT00362336|O1|Outcome|DTaP-IPV-Hep B-PRP-T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
1178772|NCT00362336|O3|Outcome|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
1178791|NCT00362297|P1|Participant Flow|Standard Dose|
1178792|NCT00362297|O2|Outcome|High Dose Acyclovir|
1178793|NCT00362297|O1|Outcome|Standardy Dose Valacyclovir|
1178794|NCT00362297|E2|Reported Event|High-dose|
1178773|NCT00362336|O2|Outcome|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
1178774|NCT00362336|O1|Outcome|DTaP-IPV-Hep B-PRP-T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
1178775|NCT00362336|O3|Outcome|DTaP-IPV-Hep B-PRP-T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
1178776|NCT00362336|O2|Outcome|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
1178804|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
1178777|NCT00362336|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
1178778|NCT00362336|O3|Outcome|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
1178779|NCT00362336|O2|Outcome|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
1178780|NCT00362336|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
1178781|NCT00362336|O3|Outcome|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
1178782|NCT00362336|O2|Outcome|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
1178783|NCT00362336|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
1178784|NCT00362336|E3|Reported Event|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
1178785|NCT00362336|E2|Reported Event|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
1178786|NCT00362336|E1|Reported Event|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
1178797|NCT00362232|B2|Baseline|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
1178798|NCT00362232|B1|Baseline|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
1178799|NCT00362232|P2|Participant Flow|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
1178800|NCT00362232|P1|Participant Flow|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
1178801|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
1178802|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
1178803|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
1178805|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
1178806|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
1178807|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
1178808|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
1178809|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
1178810|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
1178811|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
1178812|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
1178813|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
1178814|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
1178815|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
1178816|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
1178817|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
1178818|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
1178819|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
1178820|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
1178821|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
1178822|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
1179161|NCT00361439|O1|Outcome|Mometasone|Active intranasal steroid therapy daily for 2 weeks
1178823|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
1178824|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
1178825|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
1178826|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
1178827|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
1178828|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
1178829|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
1178830|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
1178831|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
1178832|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
1178833|NCT00362232|E2|Reported Event|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
1178834|NCT00362232|E1|Reported Event|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
1178835|NCT00362180|B10|Baseline|Total|Total of all reporting groups
1178836|NCT00362180|B9|Baseline|Cohort G: Placebo Followed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
1178837|NCT00362180|B8|Baseline|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
1178838|NCT00362180|B7|Baseline|Cohort F: no Study Intervention|A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
1178839|NCT00362180|B6|Baseline|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
1178840|NCT00362180|B5|Baseline|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
1178841|NCT00362180|B4|Baseline|Cohort D: Placebo|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of placebo over the course of 4 weeks.
1178842|NCT00362180|B3|Baseline|Cohort D: Mipomersen|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
1178843|NCT00362180|B2|Baseline|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
1178844|NCT00362180|B1|Baseline|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
1178845|NCT00362180|P9|Participant Flow|Cohort G: Placebo Followed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
1178846|NCT00362180|P8|Participant Flow|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
1178847|NCT00362180|P7|Participant Flow|Cohort F: no Study Intervention|A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
1178848|NCT00362180|P6|Participant Flow|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
1178849|NCT00362180|P5|Participant Flow|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
1178850|NCT00362180|P4|Participant Flow|Cohort D: Placebo|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of placebo over the course of 4 weeks.
1178851|NCT00362180|P3|Participant Flow|Cohort D: Mipomersen|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
1178852|NCT00362180|P2|Participant Flow|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
1179162|NCT00361439|O2|Outcome|Placebo|2 puffs of placebo spray once daily
1178853|NCT00362180|P1|Participant Flow|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
1178854|NCT00362180|O8|Outcome|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
1178855|NCT00362180|O7|Outcome|Cohort G: Placebo Follwed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
1178856|NCT00362180|O6|Outcome|Cohort F: No Study Intervention|A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
1178857|NCT00362180|O5|Outcome|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
1178858|NCT00362180|O4|Outcome|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
1178859|NCT00362180|O3|Outcome|Cohort D: Mipomersen|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
1178860|NCT00362180|O2|Outcome|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
1178861|NCT00362180|O1|Outcome|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
1178862|NCT00362180|O8|Outcome|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
1178863|NCT00362180|O7|Outcome|Cohort G: Placebo Followed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
1178864|NCT00362180|O6|Outcome|Cohort F: No Study Intervention|A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
1178865|NCT00362180|O5|Outcome|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
1178866|NCT00362180|O4|Outcome|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
1178867|NCT00362180|O3|Outcome|Cohort D|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
1178868|NCT00362180|O2|Outcome|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
1178869|NCT00362180|O1|Outcome|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
1178870|NCT00362180|O8|Outcome|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
1178871|NCT00362180|O7|Outcome|Cohort G: Placebo Follwed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
1178872|NCT00362180|O6|Outcome|Cohort F: No Study Intervention|A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
1178873|NCT00362180|O5|Outcome|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
1178874|NCT00362180|O4|Outcome|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
1178875|NCT00362180|O3|Outcome|Cohort D: Mipomersen|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
1178876|NCT00362180|O2|Outcome|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
1178877|NCT00362180|O1|Outcome|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
1178878|NCT00362180|O8|Outcome|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
1178879|NCT00362180|O7|Outcome|Cohort G: Placebo Followed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
1178880|NCT00362180|O6|Outcome|Cohort F: No Study Intervention|A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
1178881|NCT00362180|O5|Outcome|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
1178882|NCT00362180|O4|Outcome|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
1178883|NCT00362180|O3|Outcome|Cohort D|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
1178884|NCT00362180|O2|Outcome|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
1178885|NCT00362180|O1|Outcome|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
1178926|NCT00362115|P6|Participant Flow|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178886|NCT00362180|O8|Outcome|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
1178887|NCT00362180|O7|Outcome|Cohort G: Placebo Followed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
1178888|NCT00362180|O6|Outcome|Cohort F: No Study Intervention|A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
1178889|NCT00362180|O5|Outcome|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
1178890|NCT00362180|O4|Outcome|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
1178891|NCT00362180|O3|Outcome|Cohort D|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
1178892|NCT00362180|O2|Outcome|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
1178893|NCT00362180|O1|Outcome|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
1178894|NCT00362180|O8|Outcome|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
1178938|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178895|NCT00362180|O7|Outcome|Cohort G: Placebo Followed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
1178896|NCT00362180|O6|Outcome|Cohort F: no Study Intervention|Participants with a diagnosis of Familial Hypobetalipoproteinemia (FHBL) and were not treated with mipomersen or placebo.
1178897|NCT00362180|O5|Outcome|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
1178898|NCT00362180|O4|Outcome|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
1178899|NCT00362180|O3|Outcome|Cohort D|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
1178900|NCT00362180|O2|Outcome|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
1178901|NCT00362180|O1|Outcome|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
1178902|NCT00362180|O8|Outcome|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
1178903|NCT00362180|O7|Outcome|Cohort G: Placebo Followed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
1178904|NCT00362180|O6|Outcome|Cohort F: no Study Intervention|Participants with a diagnosis of Familial Hypobetalipoproteinemia (FHBL) and were not treated with mipomersen or placebo.
1178905|NCT00362180|O5|Outcome|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
1178906|NCT00362180|O4|Outcome|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
1178907|NCT00362180|O3|Outcome|Cohort D|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
1178908|NCT00362180|O2|Outcome|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
1178909|NCT00362180|O1|Outcome|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
1178910|NCT00362180|E3|Reported Event|Not Treated|Not Treated
1178911|NCT00362180|E2|Reported Event|Mipomersen|Mipomersen
1178912|NCT00362180|E1|Reported Event|Placebo|Placebo
1178913|NCT00362128|B1|Baseline|Observational|The study design was a cross-sectional observational cohort design.
1178914|NCT00362128|P1|Participant Flow|Observational|The study design was a cross-sectional observational cohort design.
1178915|NCT00362128|O1|Outcome|Observational|The study design was a cross-sectional observational cohort design.
1178916|NCT00362128|E1|Reported Event|Observational|The study design was a cross-sectional observational cohort design.
1178917|NCT00362115|B8|Baseline|Total|Total of all reporting groups
1178918|NCT00362115|B7|Baseline|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
1178919|NCT00362115|B6|Baseline|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178920|NCT00362115|B5|Baseline|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178921|NCT00362115|B4|Baseline|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178922|NCT00362115|B3|Baseline|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178923|NCT00362115|B2|Baseline|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178924|NCT00362115|B1|Baseline|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178925|NCT00362115|P7|Participant Flow|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
1186115|NCT00337571|E4|Reported Event|Placebo|
1178927|NCT00362115|P5|Participant Flow|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178928|NCT00362115|P4|Participant Flow|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178929|NCT00362115|P3|Participant Flow|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178930|NCT00362115|P2|Participant Flow|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178931|NCT00362115|P1|Participant Flow|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178932|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
1178933|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178934|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178935|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178936|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178937|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178939|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
1178941|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178942|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178943|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178944|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178945|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178946|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
1178947|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178948|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178949|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178950|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178951|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178952|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178953|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
1178954|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178955|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178956|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178957|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178958|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178959|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178960|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
1178961|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178962|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178963|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178964|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178965|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178966|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178967|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
1178968|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178969|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178970|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178971|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178972|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178973|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178974|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
1178975|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178976|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178977|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178978|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178979|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178980|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178981|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
1178982|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178983|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178984|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178985|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178986|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178987|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178988|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
1178989|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178990|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178991|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178992|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178993|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178994|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178995|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
1178996|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178997|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178998|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1178999|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179000|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179001|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179002|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
1179003|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179004|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179005|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179006|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179007|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179008|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179009|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
1179010|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179011|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179012|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179013|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179014|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179015|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179016|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
1179017|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179018|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179019|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179020|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179021|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179022|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179023|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
1179024|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179025|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179026|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179027|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179028|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179029|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179030|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
1179031|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179032|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179033|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179034|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179035|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179036|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179037|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
1179038|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179039|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179040|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179041|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179042|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179043|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179044|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
1179045|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179046|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179047|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179048|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179049|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179050|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179051|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
1179052|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179053|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179054|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179055|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179056|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179057|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179058|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
1179159|NCT00361439|P1|Participant Flow|Mometasone|Active intranasal steroid therapy daily for 2 weeks
1179059|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179060|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179061|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179062|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179063|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179064|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179065|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
1179066|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179067|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179068|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179069|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179070|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179071|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179577|NCT00360529|O2|Outcome|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
1179072|NCT00362115|E7|Reported Event|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
1179073|NCT00362115|E6|Reported Event|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179074|NCT00362115|E5|Reported Event|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179075|NCT00362115|E4|Reported Event|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179076|NCT00362115|E3|Reported Event|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179077|NCT00362115|E2|Reported Event|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179078|NCT00362115|E1|Reported Event|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
1179079|NCT00361972|B3|Baseline|Total|Total of all reporting groups
1179080|NCT00361972|B2|Baseline|Placebo|placebo comparator to lansoprazole 30 mg twice daily for 6 weeks
1179081|NCT00361972|B1|Baseline|Lansoprazole|lansoprazole : 30 mg of lansoprazole twice daily for 6 weeks
1179082|NCT00361972|P2|Participant Flow|Placebo|placebo comparator to lansoprazole, 30 mg, twice a day for 6 weeks
1179083|NCT00361972|P1|Participant Flow|Lansoprazole|lansoprazole : 30 mg of lansoprazole twice daily for 6 weeks
1179084|NCT00361972|O2|Outcome|Placebo|placebo comparator to lansoprazole 30 mg, twice daily for 6 weeks
1179085|NCT00361972|O1|Outcome|Lansoprazole|lansoprazole : 30 mg of lansoprazole twice daily for 6 weeks
1179086|NCT00361972|O2|Outcome|Placebo|placebo comparator to lansoprazole 30 mg, twice daily for 6 weeks
1179087|NCT00361972|O1|Outcome|Lansoprazole|lansoprazole: 30 mg lansoprazole twice daily for 6 weeks
1179088|NCT00361972|E2|Reported Event|Placebo|placebo comparator to lansoprazole 30 mg, twice daily for 6 weeks
1179089|NCT00361972|E1|Reported Event|Lansoprazole|lansoprazole : 30 mg of lansoprazole twice daily for 6 weeks
1179090|NCT00361634|B1|Baseline|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
1179091|NCT00361634|P1|Participant Flow|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
1179092|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
1179093|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
1179094|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
1179095|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
1179096|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
1179097|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
1179098|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
1179099|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
1179100|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
1179101|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
1179102|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
1179103|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
1179104|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
1179105|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
1179106|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
1179107|NCT00361634|E1|Reported Event|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
1179108|NCT00361595|B1|Baseline|Open Label|5 mg zoledronic acid in a single 15 minute IV (intervenous)
1179109|NCT00361595|P1|Participant Flow|Open Label|5 mg zoledronic acid in a single 15 minute IV (intervenous)
1179110|NCT00361595|O1|Outcome|Open Label|5 mg zoledronic acid in a single 15 minute IV (intervenous)
1179111|NCT00361595|O1|Outcome|Open Label|5 mg zoledronic acid in a single 15 minute IV (intervenous)
1179112|NCT00361595|O1|Outcome|Open Label|5 mg zoledronic acid in a single 15 minute IV (intervenous)
1179113|NCT00361595|O1|Outcome|Open Label|5 mg zoledronic acid in a single 15 minute IV (intervenous)
1179114|NCT00361595|E1|Reported Event|Open Label|5 mg zoledronic acid in a single 15 minute IV (intervenous)
1179115|NCT00361569|B5|Baseline|Total|Total of all reporting groups
1179116|NCT00361569|B4|Baseline|Placebo-b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
1179117|NCT00361569|B3|Baseline|Placebo-a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
1179118|NCT00361569|B2|Baseline|DR-2041b|Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
1179119|NCT00361569|B1|Baseline|DR-2041a|Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
1179120|NCT00361569|P4|Participant Flow|Placebo-b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
1179121|NCT00361569|P3|Participant Flow|Placebo-a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
1179122|NCT00361569|P2|Participant Flow|DR-2041b|Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
1179123|NCT00361569|P1|Participant Flow|DR-2041a|Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
1179124|NCT00361569|O4|Outcome|Placebo-b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
1179125|NCT00361569|O3|Outcome|Placebo-a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
1179126|NCT00361569|O2|Outcome|DR-2041b|Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
1179127|NCT00361569|O1|Outcome|DR-2041a|Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
1179128|NCT00361569|O4|Outcome|Placebo-b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
1179129|NCT00361569|O3|Outcome|Placebo-a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
1179130|NCT00361569|O2|Outcome|DR-2041b|Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
1179131|NCT00361569|O1|Outcome|DR-2041a|Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
1179132|NCT00361569|O4|Outcome|Placebo-b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
1179133|NCT00361569|O3|Outcome|Placebo-a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
1179134|NCT00361569|O2|Outcome|DR-2041b|Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
1179135|NCT00361569|O1|Outcome|DR-2041a|Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
1179136|NCT00361569|O4|Outcome|Placebo-b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
1179137|NCT00361569|O3|Outcome|Placebo-a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
1179138|NCT00361569|O2|Outcome|DR-2041b|Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
1179139|NCT00361569|O1|Outcome|DR-2041a|Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
1179140|NCT00361569|E4|Reported Event|Placebo-b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
1179141|NCT00361569|E3|Reported Event|Placebo-a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
1179142|NCT00361569|E2|Reported Event|DR-2041b|Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
1179143|NCT00361569|E1|Reported Event|DR-2041a|Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
1179144|NCT00361504|B3|Baseline|Total|Total of all reporting groups
1179145|NCT00361504|B2|Baseline|Oxycodone|Oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.
1179146|NCT00361504|B1|Baseline|Tapentadol (CG5503)|Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year
1179147|NCT00361504|P2|Participant Flow|Oxycodone|Oxycodone controlled release (CR) 20 to 50 mg twice daily (BID) for up to one year.
1179148|NCT00361504|P1|Participant Flow|Tapentadol (CG5503)|Tapentadol (CG5503) extended release (ER) 100 to 250 mg twice daily (BID) for up to one year
1179149|NCT00361504|O2|Outcome|Oxycodone|Oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.
1179150|NCT00361504|O1|Outcome|Tapentadol (CG5503)|Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year
1179151|NCT00361504|O2|Outcome|Oxycodone|Oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.
1179152|NCT00361504|O1|Outcome|Tapentadol (CG5503)|Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year
1179153|NCT00361504|E2|Reported Event|Oxycodone|Oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.
1179154|NCT00361504|E1|Reported Event|Tapentadol (CG5503)|Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year
1179155|NCT00361439|B3|Baseline|Total|Total of all reporting groups
1179156|NCT00361439|B2|Baseline|Placebo|2 puffs of placebo spray once daily
1179157|NCT00361439|B1|Baseline|Mometasone|Active intranasal steroid therapy daily for 2 weeks
1179158|NCT00361439|P2|Participant Flow|Placebo|2 puffs of placebo spray once daily
1179163|NCT00361439|O1|Outcome|Mometasone|Active intranasal steroid therapy daily for 2 weeks
1179164|NCT00361439|O2|Outcome|Placebo|2 puffs of placebo spray once daily
1179165|NCT00361439|O1|Outcome|Mometasone|Active intranasal steroid therapy daily for 2 weeks
1179166|NCT00361439|O2|Outcome|Placebo|2 puffs of placebo spray once daily
1179167|NCT00361439|O1|Outcome|Mometasone|Active intranasal steroid therapy daily for 2 weeks
1179168|NCT00361439|E2|Reported Event|Placebo|2 puffs of placebo spray once daily
1179169|NCT00361439|E1|Reported Event|Mometasone|Active intranasal steroid therapy daily for 2 weeks
1179170|NCT00361374|B4|Baseline|Total|Total of all reporting groups
1179171|NCT00361374|B3|Baseline|Placebo|"Placebo capsule (980mg soybean oil)~Placebo: 980 milligram/day"
1179172|NCT00361374|B2|Baseline|Docosahexaenoic Acid (DHA)|"Docosahexaenoic acid (DHA) Omega-3, 1g/day~docosahexaenoic acid: 1 gram/day"
1179173|NCT00361374|B1|Baseline|Eicosapentaenoic Acid (EPA)|"Eicosapentaenoic acid (EPA) Omega-3, 1g/day~eicosapentaenoic acid: 1 gram/day"
1179174|NCT00361374|P3|Participant Flow|Placebo|"Placebo capsule (980mg soybean oil)~Placebo: 980 milligram/day"
1179175|NCT00361374|P2|Participant Flow|Docosahexaenoic Acid (DHA)|"Docosahexaenoic acid (DHA) Omega-3, 1g/day~docosahexaenoic acid: 1 gram/day"
1179176|NCT00361374|P1|Participant Flow|Eicosapentaenoic Acid (EPA)|"Eicosapentaenoic acid (EPA) Omega-3, 1g/day~eicosapentaenoic acid: 1 gram/day"
1179177|NCT00361374|O3|Outcome|Placebo|"Placebo capsule (980mg soybean oil)~Placebo: 980 milligram/day"
1179178|NCT00361374|O2|Outcome|Docosahexaenoic Acid (DHA)|"Docosahexaenoic acid (DHA) Omega-3, 1g/day~docosahexaenoic acid: 1 gram/day"
1179179|NCT00361374|O1|Outcome|Eicosapentaenoic Acid (EPA)|"Eicosapentaenoic acid (EPA) Omega-3, 1g/day~eicosapentaenoic acid: 1 gram/day"
1179180|NCT00361374|E3|Reported Event|Placebo|"Placebo capsule (980mg soybean oil)~Placebo: 980 milligram/day"
1179181|NCT00361374|E2|Reported Event|Docosahexaenoic Acid (DHA)|"Docosahexaenoic acid (DHA) Omega-3, 1g/day~docosahexaenoic acid: 1 gram/day"
1179182|NCT00361374|E1|Reported Event|Eicosapentaenoic Acid (EPA)|"Eicosapentaenoic acid (EPA) Omega-3, 1g/day~eicosapentaenoic acid: 1 gram/day"
1179183|NCT00361335|B6|Baseline|Total|Total of all reporting groups
1179184|NCT00361335|B5|Baseline|IV Placebo + MTX|Participants received IV infusions of placebo at Week 0 and Week 12. At Week 24, depending on joint assessment results (dose regimen adjustment), participants were switched to IV infusions of 4mg/kg golimumab every 12 weeks for a minimum combined treatment period (placebo plus golimumab) of 48 weeks. This was followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition participants received MTX at the same dose as before study entry. Participants still receiving placebo infusions at Week 48 were not eligible to enter the Extension Study.
1179185|NCT00361335|B4|Baseline|4mg/kg Golimumab Only|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received placebo (sham MTX) capsules during the IV Period only.
1179186|NCT00361335|B3|Baseline|4mg/kg Golimumab + MTX|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received MTX at the same dose as before study entry.
1179187|NCT00361335|B2|Baseline|2mg/kg Golimumab Only|Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received placebo (sham MTX) capsules during the IV Period only.
1179188|NCT00361335|B1|Baseline|2mg/kg Golimumab+ MTX|Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks for a minimum of 48 weeks followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received methotrexate (MTX) at the same dose as before study entry.
1179189|NCT00361335|P7|Participant Flow|EE/DRA -> 4mg/kg Golimumab + MTX|At Week 16 and Week 24 participants entered EE and DRA, respectively, depending on joint assessment results and received IV infusions of 4mg/kg golimumab (as per protocol) for a minimum combined treatment period (initial treatment plus EE or DRA) of 48 weeks. This was followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received MTX at the same dose as before study entry.
1179190|NCT00361335|P6|Participant Flow|EE/DRA -> 2mg/kg Golimumab + MTX|At Week 16 and Week 24 participants entered early escape (EE) and dose regimen adjustment (DRA), respectively, depending on joint assessment results and received IV infusions of 2mg/kg golimumab (as per protocol) for a minimum combined treatment period (initial treatment plus EE or DRA) of 48 weeks. This was followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received MTX at the same dose as before study entry.
1179191|NCT00361335|P5|Participant Flow|IV Placebo + MTX|Participants received IV infusions of placebo at Week 0 and Week 12. At Week 24, depending on joint assessment results (dose regimen adjustment), participants were switched to IV infusions of 4mg/kg golimumab every 12 weeks for a minimum combined treatment period (placebo plus golimumab) of 48 weeks. This was followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition participants received MTX at the same dose as before study entry. Participants still receiving placebo infusions at Week 48 were not eligible to enter the Extension Study.
1179192|NCT00361335|P4|Participant Flow|4mg/kg Golimumab Only|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received placebo (sham MTX) capsules during the IV Period only.
1179193|NCT00361335|P3|Participant Flow|4mg/kg Golimumab + MTX|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received MTX at the same dose as before study entry.
1179224|NCT00361335|O7|Outcome|Group VII: Combined Groups II and IV|Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
1179194|NCT00361335|P2|Participant Flow|2mg/kg Golimumab Only|Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received placebo (sham MTX) capsules during the IV Period only.
1179195|NCT00361335|P1|Participant Flow|2mg/kg Golimumab+ MTX|Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received methotrexate (MTX) at the same dose as before study entry.
1179196|NCT00361335|O7|Outcome|Group VII: Combined Groups II and IV|Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
1179197|NCT00361335|O6|Outcome|Group VI: Combined Groups I and III|Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)
1179198|NCT00361335|O5|Outcome|Group V: IV Placebo + MTX|Participants received IV infusions of placebo at Week 0 and every 12 weeks thereafter through Week 48. In addition participants received MTX at the same dose as that before study entry.
1179199|NCT00361335|O4|Outcome|Group IV: 4mg/kg Golimumab Only|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
1179200|NCT00361335|O3|Outcome|Group III: 4mg/kg Golimumab + MTX|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received MTX at the same dose as before study entry.
1179201|NCT00361335|O2|Outcome|Group II: 2mg/kg Golimumab Only|Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
1179578|NCT00360529|O1|Outcome|Placebo|placebo at bedtime
1179202|NCT00361335|O1|Outcome|Group I: 2mg/kg Golimumab+ MTX|Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received methotrexate (MTX) at the same dose as before study entry.
1179203|NCT00361335|O7|Outcome|Group VII: Combined Groups II and IV|Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
1179204|NCT00361335|O6|Outcome|Group VI: Combined Groups I and III|Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)
1179205|NCT00361335|O5|Outcome|Group V: IV Placebo + MTX|Participants received IV infusions of placebo at Week 0 and every 12 weeks thereafter through Week 48. In addition participants received MTX at the same dose as that before study entry.
1179206|NCT00361335|O4|Outcome|Group IV: 4mg/kg Golimumab Only|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
1179207|NCT00361335|O3|Outcome|Group III: 4mg/kg Golimumab + MTX|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received MTX at the same dose as before study entry.
1179208|NCT00361335|O2|Outcome|Group II: 2mg/kg Golimumab Only|Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
1179209|NCT00361335|O1|Outcome|Group I: 2mg/kg Golimumab+ MTX|Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received methotrexate (MTX) at the same dose as before study entry.
1179210|NCT00361335|O7|Outcome|Group VII: Combined Groups II and IV|Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
1179211|NCT00361335|O6|Outcome|Group VI: Combined Groups I and III|Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)
1179212|NCT00361335|O5|Outcome|Group V: IV Placebo + MTX|Participants received IV infusions of placebo at Week 0 and every 12 weeks thereafter through Week 48. In addition participants received MTX at the same dose as that before study entry.
1179213|NCT00361335|O4|Outcome|Group IV: 4mg/kg Golimumab Only|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
1179214|NCT00361335|O3|Outcome|Group III: 4mg/kg Golimumab + MTX|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received MTX at the same dose as before study entry.
1179215|NCT00361335|O2|Outcome|Group II: 2mg/kg Golimumab Only|Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
1179216|NCT00361335|O1|Outcome|Group I: 2mg/kg Golimumab+ MTX|Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received methotrexate (MTX) at the same dose as before study entry.
1179217|NCT00361335|O7|Outcome|Group VII: Combined Groups II and IV|Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
1179218|NCT00361335|O6|Outcome|Group VI: Combined Groups I and III|Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)
1179219|NCT00361335|O5|Outcome|Group V: IV Placebo + MTX|Participants received IV infusions of placebo at Week 0 and every 12 weeks thereafter through Week 48. In addition participants received MTX at the same dose as that before study entry.
1179220|NCT00361335|O4|Outcome|Group IV: 4mg/kg Golimumab Only|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
1179221|NCT00361335|O3|Outcome|Group III: 4mg/kg Golimumab + MTX|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received MTX at the same dose as before study entry.
1179222|NCT00361335|O2|Outcome|Group II: 2mg/kg Golimumab Only|Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
1179223|NCT00361335|O1|Outcome|Group I: 2mg/kg Golimumab+ MTX|Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received methotrexate (MTX) at the same dose as before study entry.
1179268|NCT00361257|B2|Baseline|Matching Placebo|Placebo taken orally every 12 hours
1179225|NCT00361335|O6|Outcome|Group VI: Combined Groups I and III|Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)
1179226|NCT00361335|O5|Outcome|Group V: IV Placebo + MTX|Participants received IV infusions of placebo at Week 0 and every 12 weeks thereafter through Week 48. In addition participants received MTX at the same dose as that before study entry.
1179227|NCT00361335|O4|Outcome|Group IV: 4mg/kg Golimumab Only|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
1179228|NCT00361335|O3|Outcome|Group III: 4mg/kg Golimumab + MTX|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received MTX at the same dose as before study entry.
1179229|NCT00361335|O2|Outcome|Group II: 2mg/kg Golimumab Only|Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
1179230|NCT00361335|O1|Outcome|Group I: 2mg/kg Golimumab+ MTX|Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received methotrexate (MTX) at the same dose as before study entry.
1179231|NCT00361335|E7|Reported Event|SC Period: 50mg Golimumab Only|Participants who received 50mg golimumab only. Participants must not have received any MTX while receiving 50mg SC golimumab.
1179232|NCT00361335|E6|Reported Event|SC Period: 50mg Golimumab + MTX|Participants who received 50mg SC golimumab and MTX.
1179233|NCT00361335|E5|Reported Event|IV Period: Placebo + MTX|Participants who received IV placebo and MTX only. Follow-up time was counted in this group until the participant started to receive IV golimumab.
1187653|NCT00330460|E1|Reported Event|Alendronate 70 mg QW|
1179234|NCT00361335|E4|Reported Event|IV Period: 4mg/kg Golimumab Only|Participants who received at least one 4mg/kg IV golimumab dose. Follow-up time was counted in this treatment group from the first 4mg/kg IV golimumab infusion. Participants may have missed one or more golimumab doses. Participants must not have received any MTX while receiving 4mg/kg IV golimumab.
1179235|NCT00361335|E3|Reported Event|IV Period: 4mg/kg Golimumab + MTX|Participants who received at least one 4 mg/kg IV golimumab dose and MTX. Follow-up time was counted in this treatment group from the first 4mg/kg IV golimumab infusion. Participants may have missed one or more golimumab and/or MTX doses. Participants must have received MTX at some point while receiving 4mg/kg IV golimumab.
1179236|NCT00361335|E2|Reported Event|IV Period: 2mg/kg Golimumab Only|Participants who received 2mg/kg IV golimumab only. Follow-up time was counted in this treatment group until the participant started to receive 4mg/kg IV golimumab. Participants may have missed one or more golimumab doses. Participants must not have received any MTX while receiving 2mg/kg IV golimumab.
1179237|NCT00361335|E1|Reported Event|IV Period: 2mg/kg Golimumab+ MTX|Participants who received 2mg/kg IV golimumab and methotrexate (MTX). Follow-up time was counted in this treatment group until the participant started to receive 4mg/kg IV golimumab. Participants may have missed one or more golimumab and/or MTX doses. Participants must have received MTX at some point while receiving 2mg/kg IV golimumab and before receiving 4mg/kg IV golimumab
1179238|NCT00361283|B1|Baseline|Atorvastatin|80mg of atorvastatin given once daily for 16 weeks
1179239|NCT00361283|P1|Participant Flow|Atorvastatin|80mg of atorvastatin given once daily for 16 weeks
1179240|NCT00361283|O1|Outcome|Atorvastatin 80 MG/Day|Atorvastatin 80 MG/day
1179241|NCT00361283|E1|Reported Event|Atorvastatin|80mg of atorvastatin given once daily for 16 weeks
1179242|NCT00361270|B5|Baseline|Total|Total of all reporting groups
1179243|NCT00361270|B4|Baseline|Arm 4|"Single-site study at MEDVA-Houston~EMG Biofeedback without hypnotic suggestion: 8 weekly 1-hour sessions of EMG Biofeedback without hypnotic suggestion"
1179244|NCT00361270|B3|Baseline|Arm 3|"Single-site study at MEDVA-Houston~Home practice with hypnosis CDs: 2 weeks of 1-hour sessions of therapist-guided hypnosis + 6 weeks of daily home practice with hypnosis CDs"
1179245|NCT00361270|B2|Baseline|Arm 2|"Single-site study at MEDVA-Houston~Therapist-guided hypnosis: 8 weekly 1-hour sessions of therapist-guided hypnosis with home practice with hypnosis CDs"
1179246|NCT00361270|B1|Baseline|Arm 1|"Single-site study at MEDVA-Houston~Therapist-guided hypnosis: 8 weekly 1-hour sessions of therapist-guided hypnosis"
1179247|NCT00361270|P4|Participant Flow|Biofeedback - 8|8 sessions biofeedback
1179248|NCT00361270|P3|Participant Flow|Hypnosis Practice 2|2 sessions of hypnosis with practice cds
1179249|NCT00361270|P2|Participant Flow|Hypnosis-Practice 8|8 sessions hypnosis with practice cds
1179250|NCT00361270|P1|Participant Flow|Hypnosis-8|8 sessions of hypnosis with no practice cds
1179251|NCT00361270|O4|Outcome|Biofeedback - 8|8 1-hour sessions of EMG biofeedback no recordings
1179252|NCT00361270|O3|Outcome|Hypnosis Practice 2|2 1-hour sessions with hypnotherapist and audio recordings
1179253|NCT00361270|O2|Outcome|Hypnosis-Practice 8|8 1-hour sessions with hypnotherapist and audio recordings
1179254|NCT00361270|O1|Outcome|Hypnosis-8|8 1-hour sessions of hypnosis without audio recordings
1179255|NCT00361270|O4|Outcome|Biofeedback - 8|8 1-hour sessions of EMG biofeedback without recordings
1179256|NCT00361270|O3|Outcome|Hypnosis Practice 2|2 1-hour sessions with hypnotherapist with audio recordings
1179257|NCT00361270|O2|Outcome|Hypnosis-Practice 8|8 1-hour sessions with hypnotherapists with audio recordings
1179258|NCT00361270|O1|Outcome|Hypnosis-8|8 1-hour sessions of hypnosis with hypnotherapist without recordings
1179259|NCT00361270|O4|Outcome|Biofeedback - 8|8 1-hour sessions of EMG biofeedback
1179260|NCT00361270|O3|Outcome|Hypnosis Practice 2|2 1-hour sessions of hypnosis with audio recordings
1179261|NCT00361270|O2|Outcome|Hypnosis-Practice 8|8 1-hour sessions of hypnosis with audio recordings
1179262|NCT00361270|O1|Outcome|Hypnosis-8|8 1-hour sessions of hypnosis without audio recordings
1179263|NCT00361270|E4|Reported Event|Biofeedback - 8|8 1-hour sessions of EMG biofeedback without recordings
1179264|NCT00361270|E3|Reported Event|Hypnosis Practice 2|2 1-hour sessions with hypnotherapist with audio recordings
1179265|NCT00361270|E2|Reported Event|Hypnosis-Practice 8|8 1-hour sessions with hypnotherapist with audio recordings
1179266|NCT00361270|E1|Reported Event|Hypnosis-8|8 1-hour sessions with hypnotherapist
1179267|NCT00361257|B3|Baseline|Total|Total of all reporting groups
1179270|NCT00361257|P2|Participant Flow|Matching Placebo|Placebo taken orally every 12 hours
1179271|NCT00361257|P1|Participant Flow|Minocycline|100 mg orally every 12 hours
1179272|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
1179273|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
1179274|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
1179275|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
1179276|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
1179277|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
1179278|NCT00361257|O2|Outcome|Arm 2: Matching Placebo|"orally every 12 hours~Placebo (Tetracycline): Tetracycline antibiotic placebo, orally every 12 hours"
1179279|NCT00361257|O1|Outcome|Arm 1: Minocycline|"100 mg orally every 12 hours~Minocycline: Tetracycline antibiotic, 100 mg taken orally every 12 hours"
1179280|NCT00361257|O2|Outcome|Arm 2: Matching Placebo|"orally every 12 hours~Placebo (Tetracycline): Tetracycline antibiotic placebo, orally every 12 hours"
1179281|NCT00361257|O1|Outcome|Arm 1: Minocycline|"100 mg orally every 12 hours~Minocycline: Tetracycline antibiotic, 100 mg taken orally every 12 hours"
1179282|NCT00361257|O2|Outcome|Arm 2: Matching Placebo|"orally every 12 hours~Placebo (Tetracycline): Tetracycline antibiotic placebo, orally every 12 hours"
1179283|NCT00361257|O1|Outcome|Arm 1: Minocycline|"100 mg orally every 12 hours~Minocycline: Tetracycline antibiotic, 100 mg taken orally every 12 hours"
1179284|NCT00361257|O2|Outcome|Arm 2: Matching Placebo|"orally every 12 hours~Placebo (Tetracycline): Tetracycline antibiotic placebo, orally every 12 hours"
1179579|NCT00360529|O3|Outcome|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
1179285|NCT00361257|O1|Outcome|Arm 1: Minocycline|"100 mg orally every 12 hours~Minocycline: Tetracycline antibiotic, 100 mg taken orally every 12 hours"
1179286|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
1179287|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
1179288|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
1179289|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
1179290|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
1179291|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
1179292|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
1179293|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
1179294|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
1179295|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
1179296|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
1179297|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
1179298|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
1179299|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
1179300|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
1179301|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
1179302|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
1179303|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
1179304|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
1179305|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
1179306|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
1179307|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
1179308|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
1179309|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
1179310|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
1179311|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
1179312|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
1179313|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
1179314|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
1179315|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
1179316|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
1179317|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
1179318|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
1179319|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
1179320|NCT00361257|E2|Reported Event|Matching Placebo|Placebo taken orally every 12 hours
1179321|NCT00361257|E1|Reported Event|Minocycline|100 mg orally every 12 hours
1179322|NCT00361231|B1|Baseline|Bevacizumab, Gemcitabine, Oxaliplatin|"The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of study treatment.~Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.~Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.~Bevacizumab: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.~Gemcitabine: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects."
1179346|NCT00361140|E1|Reported Event|AUC Level 1|Busulfan targeted area under the curve, level 1: 6000 +/- 600 uM-min
1179347|NCT00360971|B3|Baseline|Total|Total of all reporting groups
1179348|NCT00360971|B2|Baseline|Palifermin|Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients.
1179349|NCT00360971|B1|Baseline|Placebo|Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.
1179350|NCT00360971|P2|Participant Flow|Palifermin|Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients.
1179351|NCT00360971|P1|Participant Flow|Placebo|Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.
1179323|NCT00361231|P1|Participant Flow|Bevacizumab, Gemcitabine, Oxaliplatin|"The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of study treatment.~Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.~Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.~Bevacizumab: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.~Gemcitabine: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects."
1179324|NCT00361231|O1|Outcome|Bevacizumab, Gemcitabine, Oxaliplatin|"The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of studytreatment.~Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.~Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.~Bevacizumab: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.~Gemcitabine: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.~Oxaliplatin"
1179325|NCT00361231|O1|Outcome|Bevacizumab, Gemcitabine, Oxaliplatin|"The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of studytreatment.~Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.~Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.~Bevacizumab: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.~Gemcitabine: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.~Oxaliplatin"
1179326|NCT00361231|E1|Reported Event|Bevacizumab, Gemcitabine, Oxaliplatin|"The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of study treatment.~Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.~Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.~Bevacizumab: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.~Gemcitabine: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as their disease does not progress and they do not experience any serious side eff"
1179327|NCT00361218|B1|Baseline|Open-label SSRI|"citalopram or escitalopram~open-label SSRI : Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion."
1179328|NCT00361218|P1|Participant Flow|Open-label Selective Serotonin Reuptake Inhibitor (SSRI)|"citalopram or escitalopram~open-label selective serotonin reuptake inhibitor (SSRI): Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion."
1179329|NCT00361218|O1|Outcome|Open-label Selective Serotonin Reuptake Inhibitor (SSRI)|"citalopram or escitalopram~open-label selective serotonin reuptake inhibitor (SSRI): Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion."
1179330|NCT00361218|E1|Reported Event|Open-label SSRI|"citalopram or escitalopram~open-label SSRI : Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion."
1179331|NCT00361140|B4|Baseline|Total|Total of all reporting groups
1179332|NCT00361140|B3|Baseline|AUC Level 3|Busulfan targeted area under the curve, level 3: 9000 +/- 900 uM-min
1179333|NCT00361140|B2|Baseline|AUC Level 2|Busulfan targeted area under the curve, level 2: 7500 +/- 750 uM-min
1179334|NCT00361140|B1|Baseline|AUC Level 1|Busulfan targeted area under the curve, level 1: 6000 +/- 600 uM-min
1179335|NCT00361140|P3|Participant Flow|AUC Level 3|Busulfan targeted area under the curve, level 3: 9000 +/- 900 uM-min
1179336|NCT00361140|P2|Participant Flow|AUC Level 2|Busulfan targeted area under the curve, level 2: 7500 +/- 750 uM-min
1179337|NCT00361140|P1|Participant Flow|AUC Level 1|Busulfan targeted area under the curve, level 1: 6000 +/- 600 uM-min
1179338|NCT00361140|O3|Outcome|AUC 9000|Busulfan AUC Level 3: 9000 +/- 900 uM-min Fludarabine 40 mg/m^2 I.V. over 1 hour
1179339|NCT00361140|O2|Outcome|AUC 7500|Busulfan AUC Level 2: 7500 +/- 750 uM-min Fludarabine 40 mg/m^2 I.V. over 1 hour
1179340|NCT00361140|O1|Outcome|AUC 6000|Busulfan AUC Level 1: 6000 +/- 600 uM-min Fludarabine 40 mg/m^2 I.V. over 1 hour
1179341|NCT00361140|O3|Outcome|AUC 9000|Busulfan AUC Level 3: 9000 +/- 900 uM-min Fludarabine 40 mg/m^2 I.V. over 1 hour
1179342|NCT00361140|O2|Outcome|AUC 7500|Busulfan AUC Level 2: 7500 +/- 750 uM-min Fludarabine 40 mg/m^2 I.V. over 1 hour
1179343|NCT00361140|O1|Outcome|AUC 6000|Busulfan AUC Level 1: 6000 +/- 600 uM-min Fludarabine 40 mg/m^2 I.V. over 1 hour
1179344|NCT00361140|E3|Reported Event|AUC Level 3|Busulfan targeted area under the curve, level 3: 9000 +/- 900 uM-min
1179345|NCT00361140|E2|Reported Event|AUC Level 2|Busulfan targeted area under the curve, level 2: 7500 +/- 750 uM-min
1179352|NCT00360971|O2|Outcome|Palifermin|Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients.
1179353|NCT00360971|O1|Outcome|Placebo|Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.
1179354|NCT00360971|E2|Reported Event|Palifermin|Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients.
1179355|NCT00360971|E1|Reported Event|Placebo|Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.
1179356|NCT00360828|B1|Baseline|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
1179357|NCT00360828|P1|Participant Flow|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
1190325|NCT00327717|B3|Baseline|Total|Total of all reporting groups
1179358|NCT00360828|O1|Outcome|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
1179359|NCT00360828|O1|Outcome|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
1179360|NCT00360828|O1|Outcome|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
1179361|NCT00360828|O1|Outcome|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
1179362|NCT00360828|O1|Outcome|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
1179363|NCT00360828|E1|Reported Event|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
1179364|NCT00360724|B3|Baseline|Total|Total of all reporting groups
1179365|NCT00360724|B2|Baseline|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
1179366|NCT00360724|B1|Baseline|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
1179367|NCT00360724|P2|Participant Flow|Placebo Treatment|placebo treatment, treatment with matching capsules of placebo
1179368|NCT00360724|P1|Participant Flow|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
1179369|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
1179370|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
1179371|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
1179372|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
1179373|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
1179374|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
1179375|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
1179376|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
1179377|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
1179378|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
1179379|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
1179380|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
1179381|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
1179382|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
1179383|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment, with capsules matching the duloxetine medication
1179384|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
1179385|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment, with capsules matching the duloxetine medication
1179386|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
1179387|NCT00360724|E2|Reported Event|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
1179388|NCT00360724|E1|Reported Event|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
1179389|NCT00360698|B3|Baseline|Total|Total of all reporting groups
1179390|NCT00360698|B2|Baseline|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
1179391|NCT00360698|B1|Baseline|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
1179392|NCT00360698|P2|Participant Flow|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
1179393|NCT00360698|P1|Participant Flow|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
1179394|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
1179395|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
1179396|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
1179397|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
1179398|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
1179399|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
1179400|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
1179401|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
1179402|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
1179403|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
1179404|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
1179405|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
1179406|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
1179407|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
1179408|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
1179409|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
1179570|NCT00360529|P3|Participant Flow|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
1179410|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
1179411|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
1179412|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
1179413|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
1179414|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
1179415|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
1179416|NCT00360698|E2|Reported Event|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
1190870|NCT00325897|O1|Outcome|Azithromycin|Azithromycin 250 mg
1179417|NCT00360698|E1|Reported Event|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
1179418|NCT00360685|B3|Baseline|Total|Total of all reporting groups
1179419|NCT00360685|B2|Baseline|Tacrolimus And Mycophenolate Mofetil|Tacrolimus (TAC) And Mycophenolate Mofetil (MMF)
1179420|NCT00360685|B1|Baseline|Tacrolimus And Methotrexate|Tacrolimus (TAC) And Methotrexate (MTX)
1179421|NCT00360685|P2|Participant Flow|Tacrolimus And Mycophenolate Mofetil|"All patients will receive TAC 0.03 mg/kg/24h as a continuous IV infusion beginning day –3. TAC levels should be measured on day 0 then at least twice weekly for the first month and the dose will be adjusted to maintain whole blood levels of 5-15ng/mL. When the patient is able to tolerate oral medications, the total daily dose of IV TAC will be converted to oral dosing. Full dose TAC will be given until day +60 (+7) when tapering will begin in the absence of GVHD. Provided no GVHD develops, TAC should be discontinued by day +180 (+14).~MMF 30 mg/kg/day IV in 2 divided doses beginning day 0. Dosing should be based on the lesser of adjusted ideal body weight or actual body weight. The IV dose will be converted to the oral formulation when spatient is able to tolerate oral medications. Oral dosing may be capped at 1 gram twice daily. In the absence of GVHD a tapering schedule will begin on day +240 (+14) and be completed on day +360 (+14)."
1179422|NCT00360685|P1|Participant Flow|Tacrolimus And Methotrexate|"All patients will receive TAC 0.03 mg/kg/24h as a continuous IV infusion beginning day –3 (day 0 being the anticipated day of hematopoietic stem cell infusion). Tacrolimus dosing should be based on ideal body weight. TAC levels should be measured on day 0 then at least twice weekly for the first month and the dose will be adjusted to maintain whole blood levels of 5-15ng/mL. When the patient is able to tolerate oral medications, the total daily dose of IV TAC will be converted to oral dosing at a 1:3 (IV:PO) ratio. The daily oral dose will be divided into twice daily dosing. Full dose TAC will be given until day +60 (+7) when tapering will begin in the absence of GVHD. Provided no GVHD develops, TAC should be discontinued by day +180 (+14).~MTX 15 mg/m2 IV day +1 then 10 mg/m2 IV on days +3, +6, and +11."
1179423|NCT00360685|O2|Outcome|Tacrolimus And Mycophenolate Mofetil|Tacrolimus (TAC) And Mycophenolate Mofetil (MMF)
1179424|NCT00360685|O1|Outcome|Tacrolimus And Methotrexate|Tacrolimus (TAC) And Methotrexate (MTX)
1179425|NCT00360685|O2|Outcome|Tacrolimus And Mycophenolate Mofetil|Tacrolimus (TAC) And Mycophenolate Mofetil (MMF)
1179426|NCT00360685|O1|Outcome|Tacrolimus And Methotrexate|Tacrolimus (TAC) And Methotrexate (MTX)
1179427|NCT00360685|O2|Outcome|Tacrolimus And Mycophenolate Mofetil|Tacrolimus (TAC) And Mycophenolate Mofetil (MMF)
1179428|NCT00360685|O1|Outcome|Tacrolimus And Methotrexate|Tacrolimus And Methotrexate
1179429|NCT00360685|E2|Reported Event|Tacrolimus And Mycophenolate Mofetil|Tacrolimus (TAC) And Mycophenolate Mofetil (MMF)
1179430|NCT00360685|E1|Reported Event|Tacrolimus And Methotrexate|Tacrolimus (TAC) And Methotrexate (MTX)
1179431|NCT00360672|B1|Baseline|Revlimid|Revlimid 25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
1179432|NCT00360672|P1|Participant Flow|Revlimid|Revlimid 25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
1179433|NCT00360672|O1|Outcome|Revlimid|Revlimid 25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
1179434|NCT00360672|E1|Reported Event|Revlimid|Revlimid 25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
1179435|NCT00360568|B3|Baseline|Total|Total of all reporting groups
1179436|NCT00360568|B2|Baseline|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179467|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179437|NCT00360568|B1|Baseline|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1179438|NCT00360568|P2|Participant Flow|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179580|NCT00360529|O2|Outcome|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
1179581|NCT00360529|O1|Outcome|Placebo|placebo at bedtime
1179582|NCT00360529|O3|Outcome|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
1179583|NCT00360529|O2|Outcome|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
1179439|NCT00360568|P1|Participant Flow|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received levodopa-carbidopa intestinal gel (LCIG), delivered through a percutaneous endoscopic gastrostomy with jejunal extension (PEG-J), administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1179440|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179441|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179442|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1179443|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179444|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179445|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1179446|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179447|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179448|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1179449|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179450|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179451|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1179452|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179453|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179454|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1179455|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179456|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179457|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1179458|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179584|NCT00360529|O1|Outcome|Placebo|placebo at bedtime
1179585|NCT00360529|O3|Outcome|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
1179459|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179460|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1179461|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179462|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179463|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1179464|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179465|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179466|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1186116|NCT00337571|E3|Reported Event|Aripiprazole 5 mg|
1179468|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179586|NCT00360529|O2|Outcome|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
1179587|NCT00360529|O1|Outcome|Placebo|placebo at bedtime
1179588|NCT00360529|O3|Outcome|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
1179589|NCT00360529|O2|Outcome|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
1179590|NCT00360529|O1|Outcome|Placebo|placebo at bedtime
1179591|NCT00360529|O3|Outcome|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
1179469|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1179470|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179471|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179472|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1179473|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179474|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179475|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1179476|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179477|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179478|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1190871|NCT00325897|O2|Outcome|Placebo|Inactive sugar pill
1179479|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179480|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179481|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1179482|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179483|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179484|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1179485|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179486|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179487|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1186117|NCT00337571|E2|Reported Event|Aripiprazole 15 mg|
1179488|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179592|NCT00360529|O2|Outcome|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
1179489|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179490|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1179491|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179492|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179493|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1179494|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179495|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179496|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1179497|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179565|NCT00360555|E1|Reported Event|Flibanserin 25 mg b.i.d|flibanserin: 25 mg twice daily
1179566|NCT00360529|B4|Baseline|Total|Total of all reporting groups
1179518|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179498|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179499|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1179500|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179501|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179502|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1179503|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179504|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179505|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1179506|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179507|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179508|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1179509|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179510|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179511|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1179512|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179513|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179514|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1179515|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179516|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179517|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1186118|NCT00337571|E1|Reported Event|Aripiprazole 10 mg|
1179519|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179520|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1179521|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179522|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179523|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1179524|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179525|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179526|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1179527|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179567|NCT00360529|B3|Baseline|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
1179568|NCT00360529|B2|Baseline|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
1179571|NCT00360529|P2|Participant Flow|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
1179572|NCT00360529|P1|Participant Flow|Placebo|placebo at bedtime
1179573|NCT00360529|O3|Outcome|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
1179574|NCT00360529|O2|Outcome|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
1179575|NCT00360529|O1|Outcome|Placebo|placebo at bedtime
1179576|NCT00360529|O3|Outcome|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
1179528|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179529|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1179530|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179531|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179532|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1179533|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179534|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179535|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1179536|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179537|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179538|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1179539|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179540|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179541|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1179542|NCT00360568|E3|Reported Event|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
1179543|NCT00360568|E2|Reported Event|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
1179544|NCT00360568|E1|Reported Event|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
1179545|NCT00360555|B5|Baseline|Total|Total of all reporting groups
1179546|NCT00360555|B4|Baseline|Placebo|flibanserin: placebo
1179547|NCT00360555|B3|Baseline|Flibanserin 50mg b.i.d./100mg Qhs|flibanserin: 50 mg twice daily/100 once at bedtime
1179548|NCT00360555|B2|Baseline|Flibanserin 50mg Qhs/b.i.d|flibanserin: 50 mg once at bedtime/twice daily
1179549|NCT00360555|B1|Baseline|Flibanserin 25 mg b.i.d|flibanserin: 25 mg twice daily
1179550|NCT00360555|P4|Participant Flow|Placebo|flibanserin: placebo
1179551|NCT00360555|P3|Participant Flow|Flibanserin 50mg b.i.d./100mg Qhs|flibanserin: 50 mg twice daily/100 once at bedtime
1179552|NCT00360555|P2|Participant Flow|Flibanserin 50mg Qhs/b.i.d|flibanserin: 50 mg once at bedtime/twice daily
1179553|NCT00360555|P1|Participant Flow|Flibanserin 25 mg b.i.d|flibanserin: 25 mg twice daily
1179554|NCT00360555|O4|Outcome|Placebo|flibanserin: placebo
1179555|NCT00360555|O3|Outcome|Flibanserin 50mg b.i.d./100mg Qhs|flibanserin: 50 mg twice daily/100 once at bedtime
1179556|NCT00360555|O2|Outcome|Flibanserin 50mg Qhs/b.i.d|flibanserin: 50 mg once at bedtime/twice daily
1179557|NCT00360555|O1|Outcome|Flibanserin 25 mg b.i.d|flibanserin: 25 mg twice daily
1179558|NCT00360555|O4|Outcome|Placebo|flibanserin: placebo
1179559|NCT00360555|O3|Outcome|Flibanserin 50mg b.i.d./100mg Qhs|flibanserin: 50 mg twice daily/100 once at bedtime
1179560|NCT00360555|O2|Outcome|Flibanserin 50mg Qhs/b.i.d|flibanserin: 50 mg once at bedtime/twice daily
1179561|NCT00360555|O1|Outcome|Flibanserin 25 mg b.i.d|flibanserin: 25 mg twice daily
1179562|NCT00360555|E4|Reported Event|Placebo|flibanserin: placebo
1179563|NCT00360555|E3|Reported Event|Flibanserin 50mg b.i.d./100mg Qhs|flibanserin: 50 mg twice daily/100 once at bedtime
1179564|NCT00360555|E2|Reported Event|Flibanserin 50mg Qhs/b.i.d|flibanserin: 50 mg once at bedtime/twice daily
1179594|NCT00360529|E3|Reported Event|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
1179595|NCT00360529|E2|Reported Event|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
1179596|NCT00360529|E1|Reported Event|Placebo|placebo at bedtime
1179597|NCT00360490|B3|Baseline|Total|Total of all reporting groups
1179598|NCT00360490|B2|Baseline|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
1179599|NCT00360490|B1|Baseline|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
1179600|NCT00360490|P2|Participant Flow|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
1179601|NCT00360490|P1|Participant Flow|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
1179602|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
1179603|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
1179604|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
1179605|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
1179606|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
1179607|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
1179608|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
1179609|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
1179610|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
1179611|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
1179612|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
1179613|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
1179614|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
1179615|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
1179616|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
1179617|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
1179618|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
1179619|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
1179620|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
1179621|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
1179622|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
1179623|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
1179624|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
1179625|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
1179626|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
1179627|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
1179628|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
1179629|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
1179630|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
1179631|NCT00360490|E2|Reported Event|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
1179632|NCT00360490|E1|Reported Event|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
1179633|NCT00360412|B3|Baseline|Total|Total of all reporting groups
1179685|NCT00360334|P1|Participant Flow|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
1179634|NCT00360412|B2|Baseline|Perampanel (Perampanel 2 mg or 4 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
1179635|NCT00360412|B1|Baseline|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
1179636|NCT00360412|P2|Participant Flow|Perampanel (Perampanel 2 mg or 4 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
1179637|NCT00360412|P1|Participant Flow|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
1179638|NCT00360412|O2|Outcome|Perampanel (Perampanel 2 mg or 4 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
1179639|NCT00360412|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
1179640|NCT00360412|O2|Outcome|Perampanel (Perampanel 2 mg or 4 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
1179641|NCT00360412|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
1179642|NCT00360412|O2|Outcome|Perampanel (Perampanel 2 mg or 4 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
1179674|NCT00360399|E2|Reported Event|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
1179675|NCT00360399|E1|Reported Event|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
1179735|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
1179643|NCT00360412|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
1179644|NCT00360412|O2|Outcome|Perampanel (Perampanel 2 mg or 4 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
1179645|NCT00360412|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
1179686|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
1179687|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
1179688|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
1190872|NCT00325897|O1|Outcome|Azithromycin|Azithromycin, 250 mg
1179646|NCT00360412|E2|Reported Event|Perampanel (Perampanel 2 mg or 4 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
1179647|NCT00360412|E1|Reported Event|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
1179648|NCT00360399|B4|Baseline|Total|Total of all reporting groups
1179649|NCT00360399|B3|Baseline|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
1179650|NCT00360399|B2|Baseline|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
1179651|NCT00360399|B1|Baseline|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
1179652|NCT00360399|P3|Participant Flow|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
1179653|NCT00360399|P2|Participant Flow|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
1179654|NCT00360399|P1|Participant Flow|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
1179655|NCT00360399|O3|Outcome|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
1179656|NCT00360399|O2|Outcome|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
1179657|NCT00360399|O1|Outcome|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
1179658|NCT00360399|O3|Outcome|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
1179659|NCT00360399|O2|Outcome|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
1179660|NCT00360399|O1|Outcome|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
1179661|NCT00360399|O3|Outcome|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
1179662|NCT00360399|O2|Outcome|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
1179663|NCT00360399|O1|Outcome|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
1179664|NCT00360399|O3|Outcome|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
1179665|NCT00360399|O2|Outcome|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
1179666|NCT00360399|O1|Outcome|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
1179667|NCT00360399|O3|Outcome|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
1179668|NCT00360399|O2|Outcome|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
1179669|NCT00360399|O1|Outcome|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
1179670|NCT00360399|O3|Outcome|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
1179671|NCT00360399|O2|Outcome|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
1179672|NCT00360399|O1|Outcome|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
1179673|NCT00360399|E3|Reported Event|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
1179734|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
1179676|NCT00360360|B1|Baseline|Bevacizumab/Paclitaxel/Carboplatin/Erlotinib|Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily
1179677|NCT00360360|P1|Participant Flow|Bevacizumab/Paclitaxel/Carboplatin/Erlotinib|Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily
1179678|NCT00360360|O1|Outcome|Bevacizumab/Paclitaxel/Carboplatin/Erlotinib|Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily
1179679|NCT00360360|O1|Outcome|Bevacizumab/Paclitaxel/Carboplatin/Erlotinib|Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily
1179680|NCT00360360|E1|Reported Event|Bevacizumab/Paclitaxel/Carboplatin/Erlotinib|Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily
1179681|NCT00360334|B3|Baseline|Total|Total of all reporting groups
1179682|NCT00360334|B2|Baseline|Insulin Glargine|dosing based on treat to target protocol
1179683|NCT00360334|B1|Baseline|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
1179684|NCT00360334|P2|Participant Flow|Insulin Glargine|dosing based on treat to target protocol
1179689|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
1179690|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
1179691|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
1179692|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
1179693|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
1179694|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
1179695|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
1179696|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
1179697|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
1179698|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
1179699|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
1179700|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
1179701|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
1179702|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
1179703|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
1179704|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
1179705|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
1179706|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
1179707|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
1179708|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
1179709|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
1179710|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
1179711|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
1179712|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
1179713|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
1179714|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
1179715|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
1179716|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
1179717|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
1179718|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
1179719|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
1179720|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
1179721|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
1179722|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
1179723|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
1179724|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
1179725|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
1179726|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
1179727|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
1179728|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
1179729|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
1179730|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
1179731|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
1179732|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
1179733|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
1179950|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
1179736|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
1179737|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
1179738|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
1179739|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
1179740|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
1179741|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
1179742|NCT00360334|E2|Reported Event|Insulin Glargine|dosing based on treat to target protocol
1179743|NCT00360334|E1|Reported Event|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
1179744|NCT00360308|B4|Baseline|Total|Total of all reporting groups
1179745|NCT00360308|B3|Baseline|Perampanel|Perampanel 2 mg (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
1179746|NCT00360308|B2|Baseline|Entacapone|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as one entacapone 200 mg dose with each dose of levodopa.
1179747|NCT00360308|B1|Baseline|Placebo|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
1179748|NCT00360308|P3|Participant Flow|Perampanel|Perampanel 2 mg (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
1179795|NCT00360269|E1|Reported Event|Atomoxetine|Flexible dose up to 100mg/day
1179796|NCT00360243|B5|Baseline|Total|Total of all reporting groups
1179749|NCT00360308|P2|Participant Flow|Entacapone|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as one entacapone 200 mg dose with each dose of levodopa.
1179750|NCT00360308|P1|Participant Flow|Placebo|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
1179751|NCT00360308|O3|Outcome|Perampanel|Perampanel 2 mg (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
1179752|NCT00360308|O2|Outcome|Entacapone|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as one entacapone 200 mg dose with each dose of levodopa.
1179753|NCT00360308|O1|Outcome|Placebo|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
1179754|NCT00360308|O3|Outcome|Perampanel|Perampanel 2 mg (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
1179755|NCT00360308|O2|Outcome|Entacapone|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as one entacapone 200 mg dose with each dose of levodopa.
1179756|NCT00360308|O1|Outcome|Placebo|The total number of subjects reflects 1 fewer subject due to inavailability of the data
1179757|NCT00360308|O3|Outcome|Perampanel|The total number of subjects reflects 3 fewer subjects due to inavailability of the data
1179758|NCT00360308|O2|Outcome|Entacapone|The total number of subjects reflects 5 fewer subjects due to inavailability of the data
1179759|NCT00360308|O1|Outcome|Placebo|The total number of subjects reflects 3 fewer subjects due to inavailability of the data
1179760|NCT00360308|O3|Outcome|Perampanel|Perampanel 2 mg (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
1179761|NCT00360308|O2|Outcome|Entacapone|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as one entacapone 200 mg dose with each dose of levodopa.
1179762|NCT00360308|O1|Outcome|Placebo|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
1179763|NCT00360308|E3|Reported Event|Perampanel|Perampanel 2 mg (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
1179764|NCT00360308|E2|Reported Event|Entacapone|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as one entacapone 200 mg dose with each dose of levodopa.
1179765|NCT00360308|E1|Reported Event|Placebo|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
1179766|NCT00360282|B1|Baseline|All Study Participants|Includes participants (migraineurs) with and without vertigo
1179767|NCT00360282|P4|Participant Flow|Without Vertigo; Rizatriptan - Placebo|These participants suffered from migraine without associated vertigo/dizziness. They received Rizatriptan on visit 1 and placebo on visit 2.
1179768|NCT00360282|P3|Participant Flow|With Vertigo; Rizatriptan - Placebo|These participants suffered from migraine and had associated vertigo/dizziness. They received Rizatriptan on visit 1 and placebo on visit 2.
1179769|NCT00360282|P2|Participant Flow|Without Vertigo; Placebo - Rizatriptan|These participants suffered from migraines but did not have associated dizziness/vertigo. This group received placebo on visit 1 and Rizatriptan on visit 2.
1179770|NCT00360282|P1|Participant Flow|With Vertigo; Placebo-Rizatriptan|These participants suffered from migraines with associated dizziness/vertigo. They were given placebo on visit one and Rizatriptan on visit 2.
1179771|NCT00360282|O2|Outcome|Placebo Visit|Participants were pre-treated with placebo prior to vestibular stimulation.
1179772|NCT00360282|O1|Outcome|Rizatriptan Visit|Subjects were pre-treated with Rizatriptan prior to vestibular stimulation.
1179773|NCT00360282|O2|Outcome|Placebo Visit|Participants were pre-treated with placebo prior to vestibular stimulation.
1179774|NCT00360282|O1|Outcome|Rizatriptan Visit|Subjects were pre-treated with Rizatriptan prior to vestibular stimulation.
1179775|NCT00360282|E4|Reported Event|With Vertigo; Rizatriptan|These participants suffered from migraines with associated dizziness/vertigo. They received Rizatriptan on one of the visits.
1179776|NCT00360282|E3|Reported Event|With Vertigo; Placebo|These participants suffered from migraines with associated dizziness/vertigo. They received Placebo on one of the visits.
1179951|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
1179777|NCT00360282|E2|Reported Event|Without Vertigo; Rizatriptan|These participants suffered from migraines but did not have associated dizziness/vertigo. They received Rizatriptan on one of the visits.
1179778|NCT00360282|E1|Reported Event|Without Vertigo; Placebo|These participants suffered from migraines but did not have associated dizziness/vertigo. They received Placebo on one of the visits.
1179779|NCT00360269|B3|Baseline|Total|Total of all reporting groups
1179780|NCT00360269|B2|Baseline|Placebo|Flexible dose up to 100mg/day
1179781|NCT00360269|B1|Baseline|Atomoxetine|Flexible dose up to 100mg/day
1179782|NCT00360269|P2|Participant Flow|Placebo|Flexible dose up to 100mg/day
1179783|NCT00360269|P1|Participant Flow|Atomoxetine|Flexible dose up to 100mg/day
1179784|NCT00360269|O2|Outcome|Placebo|Flexible dose up to 100mg/day
1179785|NCT00360269|O1|Outcome|Atomoxetine|Flexible dose up to 100mg/day
1179786|NCT00360269|O2|Outcome|Placebo|Flexible dose up to 100mg/day
1179787|NCT00360269|O1|Outcome|Atomoxetine|Flexible dose up to 100mg/day
1179788|NCT00360269|O2|Outcome|Placebo|Flexible dose up to 100mg/day
1179789|NCT00360269|O1|Outcome|Atomoxetine|Flexible dose up to 100mg/day
1179790|NCT00360269|O2|Outcome|Placebo|Flexible dose up to 100mg/day
1179791|NCT00360269|O1|Outcome|Atomoxetine|Flexible dose up to 100mg/day
1179792|NCT00360269|O2|Outcome|Placebo|Flexible dose up to 100mg/day
1179793|NCT00360269|O1|Outcome|Atomoxetine|Flexible dose up to 100mg/day
1179794|NCT00360269|E2|Reported Event|Placebo|Flexible dose up to 100mg/day
1179797|NCT00360243|B4|Baseline|Placebo|"twice daily for 24 weeks~placebo: placebo"
1179798|NCT00360243|B3|Baseline|Flibanserin 50mg b.i.d.|"50 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 50mg b.i.d."
1179799|NCT00360243|B2|Baseline|Flibanserin 50mg Qhs|"50 mg taken once daily at bedtime for 24 weeks~flibanserin: Experimental: flibanserin 50mg qhs"
1179800|NCT00360243|B1|Baseline|Flibanserin 25 mg b.i.d|"25 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 25 mg b.i.d"
1179801|NCT00360243|P4|Participant Flow|Placebo|"twice daily for 24 weeks~placebo: placebo"
1179802|NCT00360243|P3|Participant Flow|Flibanserin 50mg b.i.d.|"50 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 50mg b.i.d."
1179803|NCT00360243|P2|Participant Flow|Flibanserin 50mg Qhs|"50 mg taken once daily at bedtime for 24 weeks~flibanserin: Experimental: flibanserin 50mg qhs"
1179804|NCT00360243|P1|Participant Flow|Flibanserin 25 mg b.i.d|"25 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 25 mg b.i.d"
1179805|NCT00360243|O4|Outcome|Placebo|"twice daily for 24 weeks~placebo: placebo"
1179806|NCT00360243|O3|Outcome|Flibanserin 50mg b.i.d.|"50 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 50mg b.i.d."
1179807|NCT00360243|O2|Outcome|Flibanserin 50mg Qhs|"50 mg taken once daily at bedtime for 24 weeks~flibanserin: Experimental: flibanserin 50mg qhs"
1179808|NCT00360243|O1|Outcome|Flibanserin 25 mg b.i.d|"25 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 25 mg b.i.d"
1179809|NCT00360243|O4|Outcome|Placebo|"twice daily for 24 weeks~placebo: placebo"
1179810|NCT00360243|O3|Outcome|Flibanserin 50mg b.i.d.|"50 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 50mg b.i.d."
1179811|NCT00360243|O2|Outcome|Flibanserin 50mg Qhs|"50 mg taken once daily at bedtime for 24 weeks~flibanserin: Experimental: flibanserin 50mg qhs"
1179812|NCT00360243|O1|Outcome|Flibanserin 25 mg b.i.d|"25 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 25 mg b.i.d"
1179813|NCT00360243|E4|Reported Event|Placebo|"twice daily for 24 weeks~placebo: placebo"
1179814|NCT00360243|E3|Reported Event|Flibanserin 50mg b.i.d.|"50 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 50mg b.i.d."
1179815|NCT00360243|E2|Reported Event|Flibanserin 50mg Qhs|"50 mg taken once daily at bedtime for 24 weeks~flibanserin: Experimental: flibanserin 50mg qhs"
1179816|NCT00360243|E1|Reported Event|Flibanserin 25 mg b.i.d|"25 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 25 mg b.i.d"
1179817|NCT00360126|B1|Baseline|Lamotrigine|Participants received Lamotrigine tablets orally once daily up to 52 weeks in evenings or mornings (in case of non-tolerance) or the dose was administered twice daily if the morning dose was not tolerated.
1179818|NCT00360126|P1|Participant Flow|Lamotrigine|Participants received Lamotrigine tablets orally once daily up to 52 weeks in evenings or mornings (in case of non-tolerance) or the dose was administered twice daily if the morning dose was not tolerated.
1179819|NCT00360126|O1|Outcome|Lamotrigine|Participants received Lamotrigine tablets orally once daily up to 52 weeks in evenings or mornings (in case of non-tolerance) or the dose was administered twice daily if the morning dose was not tolerated.
1179820|NCT00360126|E1|Reported Event|Lamotrigine|Participants received Lamotrigine tablets orally once daily up to 52 weeks in evenings or mornings (in case of non-tolerance) or the dose was administered twice daily if the morning dose was not tolerated.
1179821|NCT00360009|B4|Baseline|Total|Total of all reporting groups
1179822|NCT00360009|B3|Baseline|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
1179823|NCT00360009|B2|Baseline|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
1179824|NCT00360009|B1|Baseline|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
1179825|NCT00360009|P3|Participant Flow|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
1179826|NCT00360009|P2|Participant Flow|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
1179827|NCT00360009|P1|Participant Flow|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
1179828|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
1179829|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
1179830|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
1179831|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
1179832|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
1179833|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
1179834|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
1179835|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
1179836|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
1179837|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
1179838|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
1179839|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
1179840|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
1179841|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
1179842|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
1179843|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
1179844|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
1179845|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
1179846|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
1179847|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
1179848|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
1179849|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
1179850|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
1179851|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
1179852|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
1179853|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
1179854|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
1179855|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
1179856|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
1179857|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
1179858|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
1179859|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
1179860|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
1179861|NCT00360009|E3|Reported Event|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
1179862|NCT00360009|E2|Reported Event|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
1179863|NCT00360009|E1|Reported Event|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
1179864|NCT00359983|B4|Baseline|Total|Total of all reporting groups
1179865|NCT00359983|B3|Baseline|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179866|NCT00359983|B2|Baseline|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179952|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
1179867|NCT00359983|B1|Baseline|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179868|NCT00359983|P3|Participant Flow|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179869|NCT00359983|P2|Participant Flow|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179870|NCT00359983|P1|Participant Flow|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179871|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179872|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179973|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1179974|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1179975|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1179873|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179874|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179875|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179876|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179877|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179878|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179879|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179880|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179881|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179882|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179883|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179884|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179885|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179886|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179887|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179888|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179889|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179890|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179953|NCT00359801|E2|Reported Event|Non-Exubera®|Usual diabetes care
1179891|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179892|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179893|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179894|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179895|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179896|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1180268|NCT00359632|B3|Baseline|Total|Total of all reporting groups
1179897|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179898|NCT00359983|E3|Reported Event|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179899|NCT00359983|E2|Reported Event|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179900|NCT00359983|E1|Reported Event|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
1179901|NCT00359944|B4|Baseline|Total|Total of all reporting groups
1179902|NCT00359944|B3|Baseline|Placebo|Sugar Pill twice daily
1179903|NCT00359944|B2|Baseline|AC-3933, 20 mg|AC-3933, 20 mg twice daily
1179904|NCT00359944|B1|Baseline|AC-3933|AC-3933, 5mg twice daily
1179905|NCT00359944|P3|Participant Flow|Placebo|Sugar Pill twice daily
1179906|NCT00359944|P2|Participant Flow|AC-3933, 20 mg|AC-3933, 20 mg twice daily
1179907|NCT00359944|P1|Participant Flow|AC-3933, 5 mg|AC-3933, 5mg twice daily
1179908|NCT00359944|O3|Outcome|Placebo|Sugar Pill twice daily
1179909|NCT00359944|O2|Outcome|AC-3933, 20 mg|AC-3933, 20 mg twice daily
1179910|NCT00359944|O1|Outcome|AC-3933, 5 mg|AC-3933, 5mg twice daily
1179911|NCT00359944|O3|Outcome|Placebo|Sugar Pill twice daily
1179912|NCT00359944|O2|Outcome|AC-3933, 20 mg|AC-3933, 20 mg twice daily
1179913|NCT00359944|O1|Outcome|AC-3933, 5 mg|AC-3933, 5mg twice daily
1179914|NCT00359944|O3|Outcome|Placebo|Sugar Pill twice daily
1179915|NCT00359944|O2|Outcome|AC-3933, 20 mg|AC-3933, 20 mg twice daily
1179916|NCT00359944|O1|Outcome|AC-3933, 5 mg|AC-3933, 5mg twice daily
1179917|NCT00359944|E3|Reported Event|Placebo|Sugar Pill twice daily
1179918|NCT00359944|E2|Reported Event|AC-3933, 20 mg|AC-3933, 20 mg twice daily
1179919|NCT00359944|E1|Reported Event|AC-3933, 5 mg|AC-3933, 5mg twice daily
1179920|NCT00359801|B3|Baseline|Total|Total of all reporting groups
1179921|NCT00359801|B2|Baseline|Non-Exubera®|Usual diabetes care
1179922|NCT00359801|B1|Baseline|Exubera®|Exubera® plus usual diabetes care
1179923|NCT00359801|P2|Participant Flow|Non-Exubera®|Usual diabetes care
1179924|NCT00359801|P1|Participant Flow|Exubera®|Exubera® plus usual diabetes care
1179925|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
1179926|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
1179927|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
1179928|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
1179929|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
1179930|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
1179931|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
1179932|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
1179933|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
1179934|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
1179935|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
1179936|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
1179937|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
1179938|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
1179939|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
1179940|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
1179941|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
1179942|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
1179943|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
1179944|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
1179945|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
1179946|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
1179947|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
1179948|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
1179949|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
1179954|NCT00359801|E1|Reported Event|Exubera®|Exubera® plus usual diabetes care
1179955|NCT00359788|B3|Baseline|Total|Total of all reporting groups
1179956|NCT00359788|B2|Baseline|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1179957|NCT00359788|B1|Baseline|Tiotropium|18 mcg once daily
1179958|NCT00359788|P2|Participant Flow|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1179959|NCT00359788|P1|Participant Flow|Tiotropium|18 mcg once daily
1179960|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1179961|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1179962|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1179963|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1179964|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1179965|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1179966|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1179967|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1179968|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1179969|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1179970|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1179971|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1179972|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1179976|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1179977|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1179978|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1179979|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1179980|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1179981|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1179982|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1179983|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1179984|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1179985|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1179986|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1179987|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1179988|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1179989|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1179990|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1179991|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1179992|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1179993|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1179994|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1179995|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1179996|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1179997|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1179998|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1179999|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180000|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180001|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180002|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180003|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180004|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180005|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180006|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180007|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180008|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180009|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180010|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180011|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180012|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180013|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180014|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180015|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180016|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180017|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180018|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180019|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180020|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180021|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180022|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180023|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180024|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180025|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180026|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180027|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180028|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180029|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180030|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180031|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180032|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180033|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180034|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180036|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180037|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180038|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180039|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180040|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180041|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180042|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180043|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180044|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180045|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180046|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180047|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180048|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180049|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180050|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180051|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180052|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180053|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180054|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180055|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180056|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180057|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180058|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180059|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180060|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180061|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180062|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180063|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180064|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180065|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180066|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180067|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180068|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180069|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180070|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180071|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180072|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180073|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180074|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180075|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180076|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180077|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180078|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180079|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180080|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180081|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180082|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180083|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180084|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180085|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180086|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180087|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180088|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180089|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180090|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180091|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180092|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180093|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180094|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180095|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180096|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180097|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180098|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180099|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180100|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180101|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180102|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180103|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180104|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180105|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180106|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180107|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180108|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180109|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180110|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180111|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180112|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180113|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180114|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180115|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180116|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180118|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180119|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180120|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180121|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180122|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180123|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180124|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180125|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180126|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180127|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180128|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180129|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180130|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180131|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180132|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180133|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180134|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180135|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180136|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180137|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180138|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180139|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180140|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180141|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180142|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180143|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180144|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180145|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180146|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180147|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180148|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180149|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180150|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180151|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180152|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180153|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180154|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180155|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180156|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180157|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180158|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180159|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180160|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180161|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180162|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180163|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180164|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180165|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180166|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180167|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180168|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180169|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180170|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180171|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180172|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180173|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180174|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180175|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180176|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180177|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180178|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180179|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180180|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180181|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180182|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180183|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180184|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180185|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180186|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180187|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
1180188|NCT00359788|E2|Reported Event|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
1180189|NCT00359788|E1|Reported Event|Tiotropium|18 mcg once daily
1180190|NCT00359762|B3|Baseline|Total|Total of all reporting groups
1180191|NCT00359762|B2|Baseline|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
1180192|NCT00359762|B1|Baseline|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
1180193|NCT00359762|P5|Participant Flow|Period II, Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
1180194|NCT00359762|P4|Participant Flow|Period III, Glim + Met + Exen - Not Randomized|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for the first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period III) was added to oral Glimepiride once daily and daily oral Metformin in Period III
1180195|NCT00359762|P3|Participant Flow|Period III, Exen + Met + Pio or Rosi - Randomized|Oral Rosiglitazone or Pioglitazone once or twice daily, started 15 mg per day, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
1180196|NCT00359762|P2|Participant Flow|Period III, Exen + Met + Glim - Randomized|Glimepiride once daily, started at 1 mg dose and titrated up to maintenance doses, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
1180197|NCT00359762|P1|Participant Flow|Period II, Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
1180198|NCT00359762|O3|Outcome|Glim + Met + Exen - Not Randomized|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for the first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period III) was added to oral Glimepiride once daily and daily oral Metformin in Period III
1180199|NCT00359762|O2|Outcome|Exen + Met + Pio or Rosi - Randomized|Oral Rosiglitazone or Pioglitazone once or twice daily, started 15 mg per day, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
1180200|NCT00359762|O1|Outcome|Exen + Metformin + Glim - Randomized|Glimepiride once daily, started at 1 mg dose and titrated up to maintenance doses, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
1190873|NCT00325897|O2|Outcome|Placebo|Inactive sugar pill
1180201|NCT00359762|O1|Outcome|Glim + Met + Exen - Not Randomized|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for the first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period III) was added to oral Glimepiride once daily and daily oral Metformin in Period III
1180202|NCT00359762|O2|Outcome|Exen + Met + Pio or Rosi - Randomized|Oral Rosiglitazone or Pioglitazone once or twice daily, started 15 mg per day, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
1180203|NCT00359762|O1|Outcome|Exen + Met + Glim - Randomized|Glimepiride once daily, started at 1 mg dose and titrated up to maintenance doses, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
1180204|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
1180205|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
1180206|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
1180207|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
1180208|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
1180209|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
1180210|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
1180211|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
1180212|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
1180213|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
1180214|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
1180215|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
1180216|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
1180217|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
1180218|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
1180219|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
1180220|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
1180221|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
1180222|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
1180223|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
1180224|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
1180225|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
1180226|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
1180227|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
1180228|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
1180229|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
1180230|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
1180231|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
1180750|NCT00358449|P3|Participant Flow|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180232|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
1180233|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
1180234|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
1180235|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
1180236|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
1180237|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
1180238|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
1180239|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
1180240|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
1180241|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
1180242|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
1180243|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
1180244|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
1180245|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
1180246|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
1180247|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
1180248|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
1180249|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
1180250|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
1180251|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
1180252|NCT00359762|E5|Reported Event|Period II, Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
1180253|NCT00359762|E4|Reported Event|Period III, Glim + Met + Exen - Not Randomized|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for the first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period III) was added to oral Glimepiride once daily and daily oral Metformin in Period III
1180254|NCT00359762|E3|Reported Event|Period III, Exen + Met + Pio or Rosi - Randomized|Oral Rosiglitazone or Pioglitazone once or twice daily, started 15 mg per day, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
1180627|NCT00358826|O4|Outcome|Placebo|Matching Placebo, oral dosing, 12 weeks
1180255|NCT00359762|E2|Reported Event|Period III, Exen + Met + Glim - Randomized|Glimepiride once daily, started at 1 mg dose and titrated up to maintenance doses, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
1180256|NCT00359762|E1|Reported Event|Period II, Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
1180257|NCT00359736|B3|Baseline|Total|Total of all reporting groups
1180258|NCT00359736|B2|Baseline|Placebo|Identical Placebo: 20 mg TID orally
1180259|NCT00359736|B1|Baseline|Sildenafil|Sildenafil 20 mg TID orally: Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients.
1180260|NCT00359736|P2|Participant Flow|Placebo|Control group: Identical Placebo 20 mg TID orally
1180261|NCT00359736|P1|Participant Flow|Sildenafil|Sildenafil 20 mg TID orally : Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients.
1180262|NCT00359736|O2|Outcome|Placebo|Identical Placebo 20mg tid orally
1180263|NCT00359736|O1|Outcome|Sildenafil|Sildenafil 20 mg tid orally
1180264|NCT00359736|O2|Outcome|Placebo|Identical Placebo 20 mg tid
1180265|NCT00359736|O1|Outcome|Sildenafil|"Sildenafil 20 mg tid~sildenafil: Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients."
1180266|NCT00359736|E2|Reported Event|Sildenafil|sildenafil : Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients.
1180267|NCT00359736|E1|Reported Event|Placebo|Control group
1180269|NCT00359632|B2|Baseline|Control|Control participants individually matched to linezolid participants (on age, gender, and type of infection) received antibiotics other than linezolid per standard of care at the discretion of the treating investigator, for at least 6 weeks (at least 42 days). The control group was only assessed at the baseline visit to identify the presence of background abnormalities in the study test panel.
1180270|NCT00359632|B1|Baseline|Linezolid|Participants received linezolid either as tablets, PO or as an IV infusion at a dose of 600 mg, BID. Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days).
1180271|NCT00359632|P2|Participant Flow|Control|Control participants individually matched to linezolid participants (on age, gender, and type of infection) received antibiotics other than linezolid per standard of care at the discretion of the treating investigator, for at least 6 weeks (at least 42 days). The control group was only assessed at the baseline visit to identify the presence of background abnormalities in the study test panel.
1180272|NCT00359632|P1|Participant Flow|Linezolid|Participants received linezolid either as tablets, by mouth (PO) or as an intravenous (IV) infusion at a dose of 600 milligrams (mg), twice daily (BID). Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days).
1180273|NCT00359632|O1|Outcome|Linezolid|Participants received linezolid either as tablets, PO or as an IV infusion at a dose of 600 mg, BID. Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days).
1180274|NCT00359632|O2|Outcome|Control|Control participants individually matched to linezolid participants (on age, gender, and type of infection) received antibiotics other than linezolid per standard of care at the discretion of the treating investigator, for at least 6 weeks (at least 42 days). The control group was only assessed at the baseline visit to identify the presence of background abnormalities in the study test panel.
1180275|NCT00359632|O1|Outcome|Linezolid|Participants received linezolid either as tablets, PO or as an IV infusion at a dose of 600 mg, BID. Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days).
1180276|NCT00359632|E2|Reported Event|Control|Control participants individually matched to linezolid participants (on age, gender, and type of infection) received antibiotics other than linezolid per standard of care at the discretion of the treating investigator, for at least 6 weeks (at least 42 days). The control group was only assessed at the baseline visit to identify the presence of background abnormalities in the study test panel.
1180277|NCT00359632|E1|Reported Event|Linezolid|Participants received linezolid either as tablets, PO or as an IV infusion at a dose of 600 mg, BID. Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days).
1180278|NCT00359619|B8|Baseline|Total|Total of all reporting groups
1180279|NCT00359619|B7|Baseline|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180280|NCT00359619|B6|Baseline|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180281|NCT00359619|B5|Baseline|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180282|NCT00359619|B4|Baseline|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180283|NCT00359619|B3|Baseline|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180284|NCT00359619|B2|Baseline|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1186189|NCT00337350|E1|Reported Event|Rosiglitazone|rosiglitazone 4mg/day
1180285|NCT00359619|B1|Baseline|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180286|NCT00359619|P7|Participant Flow|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180287|NCT00359619|P6|Participant Flow|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180288|NCT00359619|P5|Participant Flow|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180289|NCT00359619|P4|Participant Flow|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180290|NCT00359619|P3|Participant Flow|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1181053|NCT00357955|E2|Reported Event|Usual Care|usual care
1190874|NCT00325897|O1|Outcome|Azithromycin|Azithromycin, 250 mg
1180291|NCT00359619|P2|Participant Flow|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180292|NCT00359619|P1|Participant Flow|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180293|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180294|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180295|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180296|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180297|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180298|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180299|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180300|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180301|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180302|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180303|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180304|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180305|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180306|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180307|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180308|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180309|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180462|NCT00359281|P9|Participant Flow|ER Niacin 1000 mg + Lomitapide 10 mg|One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
1180310|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180311|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180312|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180313|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180314|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180315|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180316|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180317|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180318|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180319|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180320|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180321|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180322|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180323|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180324|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180325|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180326|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180327|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180328|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180329|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180330|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180331|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180332|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180333|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180334|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180335|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180336|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180337|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180338|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180339|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180340|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180341|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180342|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180343|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180344|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180345|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180346|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180347|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180348|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180349|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180350|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180351|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180352|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180353|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180354|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180355|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180356|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180357|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180358|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180359|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180360|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180361|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180362|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180363|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180364|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180365|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180366|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180367|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180368|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180369|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180370|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180371|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180372|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180373|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180374|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180375|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180376|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180377|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180378|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180379|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180380|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180381|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180382|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180383|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180384|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180385|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180386|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180387|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180388|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180389|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180390|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180391|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180392|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180393|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180394|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180395|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180396|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180397|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180398|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180399|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180400|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180401|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180402|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180403|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180404|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180405|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180406|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180407|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180408|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180409|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180410|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180411|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180412|NCT00359619|E7|Reported Event|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180413|NCT00359619|E6|Reported Event|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180414|NCT00359619|E5|Reported Event|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180415|NCT00359619|E4|Reported Event|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180416|NCT00359619|E3|Reported Event|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180417|NCT00359619|E2|Reported Event|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180418|NCT00359619|E1|Reported Event|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1180419|NCT00359424|B3|Baseline|Total|Total of all reporting groups
1180420|NCT00359424|B2|Baseline|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
1180421|NCT00359424|B1|Baseline|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
1180422|NCT00359424|P2|Participant Flow|IV Rt-PA Alone|IV rt-PA alone (group one) received the standard dose (.9mg per kilogram with 10% as a bolus and the remainder as an infusion over 1 hour -maximum dose 90mg) of intravenous (IV) rt-PA alone.
1180423|NCT00359424|P1|Participant Flow|Endovascular Therapy|Endovascular therapy (group two) received a lower dose (0.09mg per kg bolus and 0.54mg/kilogram infusion over 40 minutes, maximum dose 53.6mg) or after Amendment #5, a standard dose of IV rt-PA (.9mg/kg with 10% as a bolus and the remainder over one hour) and then underwent an angiogram test (cerebral angiography) right after the medicine was given to check for blood clots. If a clot was not seen, then no more treatment was given. If a clot was seen, the neurointerventionalist chose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that would be most effective in reopening the blocked artery.
1180424|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
1180425|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
1180426|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
1180427|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
1180428|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
1180429|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
1180430|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
1180431|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
1180432|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
1180433|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
1180434|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
1180435|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
1180436|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
1180437|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
1180438|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
1180439|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
1180440|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
1180469|NCT00359281|P2|Participant Flow|Simvastatin 20 mg + Lomitapide 10 mg|One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg
1181175|NCT00357656|O1|Outcome|Bolus Infusion|Bolus infusion of ADVATE (rAHF-PFM)
1180441|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
1180442|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
1180443|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
1180444|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
1180445|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
1180446|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
1180447|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
1180448|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
1180449|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
1180450|NCT00359424|E2|Reported Event|IV Only|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
1180451|NCT00359424|E1|Reported Event|Endovascular|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) rightafter the medicine is given to check for blood clots. If a clot is not seenthen no more treatment will be given. If a clot is seen, theneurointerventionalist will then choose (based on the location andextent of the blood clot) a protocol approved endovascular treatmentgiven directly in the brain artery that will be most effective inreopening the blocked artery.
1180452|NCT00359281|B10|Baseline|Total|Total of all reporting groups
1180453|NCT00359281|B9|Baseline|ER Niacin 1000 mg + Lomitapide 10 mg|One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
1180454|NCT00359281|B8|Baseline|Dextrometh-rophan 30 mg + Lomitapide 60 mg|One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg
1180455|NCT00359281|B7|Baseline|Rosuvastatin 20 mg + Lomitapide 60 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg
1180456|NCT00359281|B6|Baseline|Atorvastatin 20 mg + Lomitapide 60 mg|One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg
1180457|NCT00359281|B5|Baseline|Fenofibrate 145 mg + Lomitapide 10 mg|One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg
1180458|NCT00359281|B4|Baseline|Rosuvastatin 20 mg + Lomitapide 10 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg
1180459|NCT00359281|B3|Baseline|Ezetimibe 10 mg + Lomitapide 10 mg|One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg
1180460|NCT00359281|B2|Baseline|Simvastatin 20 mg + Lomitapide 10 mg|One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg
1180461|NCT00359281|B1|Baseline|Atorvastatin 20 mg + Lomitapide 10 mg|One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg
1180571|NCT00358917|E1|Reported Event|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
1180463|NCT00359281|P8|Participant Flow|Dextrometh-rophan 30 mg + Lomitapide 60 mg|One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg
1180464|NCT00359281|P7|Participant Flow|Rosuvastatin 20 mg + Lomitapide 60 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg
1180465|NCT00359281|P6|Participant Flow|Atorvastatin 20 mg + Lomitapide 60 mg|One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg
1180466|NCT00359281|P5|Participant Flow|Fenofibrate 145 mg + Lomitapide 10 mg|One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg
1180467|NCT00359281|P4|Participant Flow|Rosuvastatin 20 mg + Lomitapide 10 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg
1180468|NCT00359281|P3|Participant Flow|Ezetimibe 10 mg + Lomitapide 10 mg|One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg
1190875|NCT00325897|O2|Outcome|Placebo|Inactive sugar pill
1180470|NCT00359281|P1|Participant Flow|Atorvastatin 20 mg + Lomitapide 10 mg|One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg
1180471|NCT00359281|O1|Outcome|ER Niacin 1000 mg + Lomitapide 10 mg|One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
1180472|NCT00359281|O1|Outcome|ER Niacin 1000 mg + Lomitapide 10 mg|One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
1180473|NCT00359281|O1|Outcome|Rosuvastatin 20 mg + Lomitapide 60 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg
1180474|NCT00359281|O1|Outcome|Atorvastatin 20 mg + Lomitapide 60 mg|One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg
1180475|NCT00359281|O1|Outcome|Fenofibrate 145 mg + Lomitapide 10 mg|One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg
1180476|NCT00359281|O1|Outcome|Rosuvastatin 20 mg + Lomitapide 10 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg
1180477|NCT00359281|O1|Outcome|Ezetimibe 10 mg + Lomitapide 10 mg|One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg
1180478|NCT00359281|O1|Outcome|Simvastatin 20 mg + Lomitapide 10 mg|One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg
1180479|NCT00359281|O1|Outcome|Simvastatin 20 mg + Lomitapide 10 mg|One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg
1180480|NCT00359281|O9|Outcome|ER Niacin 1000 mg + Lomitapide 10 mg|One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
1180481|NCT00359281|O8|Outcome|Dextrometh-rophan 30 mg + Lomitapide 60 mg|One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg
1180482|NCT00359281|O7|Outcome|Rosuvastatin 20 mg + Lomitapide 60 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg
1180483|NCT00359281|O6|Outcome|Atorvastatin 20 mg + Lomitapide 60 mg|One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg
1180484|NCT00359281|O5|Outcome|Fenofibrate 145 mg + Lomitapide 10 mg|One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg
1180485|NCT00359281|O4|Outcome|Rosuvastatin 20 mg + Lomitapide 10 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg
1180486|NCT00359281|O3|Outcome|Ezetimibe 10 mg + Lomitapide 10 mg|One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg
1180487|NCT00359281|O2|Outcome|Simvastatin 20 mg + Lomitapide 10 mg|One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg
1180488|NCT00359281|O1|Outcome|Atorvastatin 20 mg + Lomitapide 10 mg|One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg
1180489|NCT00359281|O1|Outcome|Atorvastatin 20 mg + Lomitapide 10 mg|One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg
1180490|NCT00359281|E9|Reported Event|ER Niacin 1000 mg + Lomitapide 10 mg|One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
1180491|NCT00359281|E8|Reported Event|Dextrometh-rophan 30 mg + Lomitapide 60 mg|One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg
1180492|NCT00359281|E7|Reported Event|Rosuvastatin 20 mg + Lomitapide 60 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg
1180493|NCT00359281|E6|Reported Event|Atorvastatin 20 mg + Lomitapide 60 mg|One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg
1180494|NCT00359281|E5|Reported Event|Fenofibrate 145 mg + Lomitapide 10 mg|One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg
1180495|NCT00359281|E4|Reported Event|Rosuvastatin 20 mg + Lomitapide 10 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg
1180496|NCT00359281|E3|Reported Event|Ezetimibe 10 mg + Lomitapide 10 mg|One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg
1180497|NCT00359281|E2|Reported Event|Simvastatin 20 mg + Lomitapide 10 mg|One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg
1180498|NCT00359281|E1|Reported Event|Atorvastatin 20 mg + Lomitapide 10 mg|One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg
1180499|NCT00359216|B3|Baseline|Total|Total of all reporting groups
1180500|NCT00359216|B2|Baseline|Placebo Nasal Spray|The placebo nasal spray was identical in appearance to the active MFNS. The composition was identical to the commercial formulation, an aqueous suspension without the active ingredient (mometasone furoate monohydrate). The administration was identical to MFNS.
1180501|NCT00359216|B1|Baseline|Mometasone Furoate Nasal Spray|100 mg of suspension provided 50 mg of mometasone furoate monohydrate. Subjects were instructed to administer 2 sprays into each nostril every morning. The total dosage of 4 sprays (2 per nostril) thus provided 200 mg daily to subjects receiving active drug. Treatment was to be administered for a nominal period of 28 days, to a maximum of 32 days.
1180502|NCT00359216|P2|Participant Flow|Placebo Nasal Spray|The placebo nasal spray was identical in appearance to the active MFNS. The composition was identical to the commercial formulation, an aqueous suspension without the active ingredient (mometasone furoate monohydrate). The administration was identical to MFNS.
1180637|NCT00358826|E2|Reported Event|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
1180638|NCT00358826|E1|Reported Event|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
1180503|NCT00359216|P1|Participant Flow|Mometasone Furoate Nasal Spray|100 mg of suspension provided 50 mg of mometasone furoate monohydrate. Subjects were instructed to administer 2 sprays into each nostril every morning. The total dosage of 4 sprays (2 per nostril) thus provided 200 mg daily to subjects receiving active drug. Treatment was to be administered for a nominal period of 28 days, to a maximum of 32 days.
1180504|NCT00359216|O2|Outcome|Placebo Nasal Spray|The placebo nasal spray was identical in appearance to the active MFNS. The composition was identical to the commercial formulation, an aqueous suspension without the active ingredient (mometasone furoate monohydrate). The administration was identical to MFNS.
1180505|NCT00359216|O1|Outcome|Mometasone Furoate Nasal Spray|100 mg of suspension provided 50 mg of mometasone furoate monohydrate. Subjects were instructed to administer 2 sprays into each nostril every morning. The total dosage of 4 sprays (2 per nostril) thus provided 200 mg daily to subjects receiving active drug. Treatment was to be administered for a nominal period of 28 days, to a maximum of 32 days.
1180506|NCT00359216|E2|Reported Event|Placebo Nasal Spray|The placebo nasal spray was identical in appearance to the active MFNS. The composition was identical to the commercial formulation, an aqueous suspension without the active ingredient (mometasone furoate monohydrate). The administration was identical to MFNS.
1180507|NCT00359216|E1|Reported Event|Mometasone Furoate Nasal Spray|100 mg of suspension provided 50 mg of mometasone furoate monohydrate. Subjects were instructed to administer 2 sprays into each nostril every morning. The total dosage of 4 sprays (2 per nostril) thus provided 200 mg daily to subjects receiving active drug. Treatment was to be administered for a nominal period of 28 days, to a maximum of 32 days.
1180508|NCT00359203|B3|Baseline|Total|Total of all reporting groups
1180509|NCT00359203|B2|Baseline|Dual Chamber Pacemeker ON|Implant dual chamber pacemaker programmed ON and with Rate Drope Response algorhythm programmed ON
1180510|NCT00359203|B1|Baseline|Dual Chamber Pacemaker OFF|Implant dual chamber pacemaker programmed ODO (switched OFF)
1180511|NCT00359203|P2|Participant Flow|Dual Chamber Pacemeker ON|Implant dual chamber pacemaker programmed ON and with Rate Drope Response algorhythm programmed ON
1180512|NCT00359203|P1|Participant Flow|Dual Chamber Pacemaker OFF|Implant dual chamber pacemaker programmed ODO (switched OFF)
1180513|NCT00359203|O2|Outcome|Dual Chamber Pacemeker ON|Implant dual chamber pacemaker programmed ON and with Rate Drope Response algorhythm programmed ON
1180514|NCT00359203|O1|Outcome|Dual Chamber Pacemaker OFF|Implant dual chamber pacemaker programmed ODO (switched OFF)
1180515|NCT00359203|E2|Reported Event|Dual Chamber Pacemeker ON|Implant dual chamber pacemaker programmed ON and with Rate Drope Response algorhythm programmed ON
1180516|NCT00359203|E1|Reported Event|Dual Chamber Pacemaker OFF|Implant dual chamber pacemaker programmed ODO (switched OFF)
1180517|NCT00359138|B4|Baseline|Total|Total of all reporting groups
1180518|NCT00359138|B3|Baseline|Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
1180519|NCT00359138|B2|Baseline|Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
1180520|NCT00359138|B1|Baseline|Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
1180521|NCT00359138|P3|Participant Flow|Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
1180522|NCT00359138|P2|Participant Flow|Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
1180523|NCT00359138|P1|Participant Flow|Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
1180524|NCT00359138|O3|Outcome|Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
1180525|NCT00359138|O2|Outcome|Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
1180526|NCT00359138|O1|Outcome|Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
1180527|NCT00359138|E3|Reported Event|Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
1180528|NCT00359138|E2|Reported Event|Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
1180529|NCT00359138|E1|Reported Event|Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
1180530|NCT00359021|B3|Baseline|Total|Total of all reporting groups
1180625|NCT00358826|O2|Outcome|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
1180626|NCT00358826|O1|Outcome|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
1180531|NCT00359021|B2|Baseline|DUET TMC125|Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
1180532|NCT00359021|B1|Baseline|DUET PLACEBO|Participants who received Placebo in a previous DUET study and received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
1180533|NCT00359021|P2|Participant Flow|DUET TMC125|Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
1180534|NCT00359021|P1|Participant Flow|DUET PLACEBO|Participants who received Placebo in a previous DUET study and received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
1180535|NCT00359021|O2|Outcome|DUET TMC125|Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
1180536|NCT00359021|O1|Outcome|DUET PLACEBO|Participants who received Placebo in a previous DUET study received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
1180537|NCT00359021|O2|Outcome|DUET TMC125|Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
1180538|NCT00359021|O1|Outcome|DUET PLACEBO|Participants who received Placebo in a previous DUET study received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
1180539|NCT00359021|O3|Outcome|All Participants|DUET Placebo + DUET TMC125
1180540|NCT00359021|O2|Outcome|DUET TMC125|Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
1180541|NCT00359021|O1|Outcome|DUET PLACEBO|Participants who received Placebo in a previous DUET study received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
1180542|NCT00359021|E3|Reported Event|All Participants|Participants who received placebo or TMC125 in a previous DUET study (DUET Placebo + DUET TMC125).
1180543|NCT00359021|E2|Reported Event|DUET TMC125|Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
1180544|NCT00359021|E1|Reported Event|DUET PLACEBO|Participants who received Placebo in a previous DUET study and received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
1180545|NCT00358956|B1|Baseline|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
1180546|NCT00358956|P1|Participant Flow|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
1180547|NCT00358956|O1|Outcome|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
1180548|NCT00358956|O1|Outcome|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
1180549|NCT00358956|O1|Outcome|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
1180550|NCT00358956|O1|Outcome|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
1180551|NCT00358956|O1|Outcome|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
1180552|NCT00358956|O1|Outcome|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
1180553|NCT00358956|O1|Outcome|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
1180554|NCT00358956|E1|Reported Event|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
1180555|NCT00358917|B3|Baseline|Total|Total of all reporting groups
1180556|NCT00358917|B2|Baseline|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
1180557|NCT00358917|B1|Baseline|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
1180558|NCT00358917|P2|Participant Flow|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 milligram (mg) twice daily (BID) tablet
1180559|NCT00358917|P1|Participant Flow|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 milligram (mg) once daily (QD) tablet
1180560|NCT00358917|O2|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
1180561|NCT00358917|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
1180562|NCT00358917|O2|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet; 81% NNRTI-experienced, 45% PI-experienced (20% nelfinavir, 17% indinavir, 13% atazanavir).
1180563|NCT00358917|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet; 88% NNRTI-experienced, 47% PI-experienced (24% nelfinavir, 19% indinavir, 13% atazanavir).
1180564|NCT00358917|O2|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
1180565|NCT00358917|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
1180566|NCT00358917|O2|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
1180567|NCT00358917|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
1180568|NCT00358917|O2|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
1180569|NCT00358917|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
1180570|NCT00358917|E2|Reported Event|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
1180572|NCT00358150|B1|Baseline|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
1180639|NCT00358735|B3|Baseline|Total|Total of all reporting groups
1180640|NCT00358735|B2|Baseline|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
1180573|NCT00358150|P1|Participant Flow|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 milligram (mg) dose on Day 1 then eliglustat 50 mg twice daily (BID) from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 nanogram per milliliter [ng/mL] on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme), and if all other causes for lack of treatment effect had been evaluated and ruled out).
1180574|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
1180575|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
1180576|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 8. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
1180577|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
1180578|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
1180579|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
1180580|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
1180581|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
1180582|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
1180583|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
1180584|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
1180585|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
1180586|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
1180587|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
1180588|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
1180589|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
1180590|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
1180591|NCT00358150|E3|Reported Event|Eliglustat|Participants who received eliglustat capsule as a single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID or eliglustat 100 mg BID from Day 20 to Year 9. Participants who discontinued prior to Day 20 dose had their dose group set to missing and are only included in the all participants group. The Eliglustat group contains all participants who were treated with Eliglustat, including 2 participants dosed with 50 mg QD and 1 participant dosed with 150 mg BID for majority of study. Participants who had dose adjustment will be presented in dose group they received for majority of study.
1180592|NCT00358150|E2|Reported Event|Eliglustat 100 mg BID|Participants who received eliglustat capsule as single 50 mg dose on Day 1 followed by eliglustat 50 mg capsule BID from Day 2 to Day 19 and then eliglustat 100 mg capsule BID from Day 20 to Year 9.
1180593|NCT00358150|E1|Reported Event|Eliglustat 50 mg BID|Participants who received eliglustat capsule as single 50 mg dose on Day 1 followed by eliglustat 50 mg BID from Day 2 to Year 9.
1180594|NCT00358826|B5|Baseline|Total|Total of all reporting groups
1180595|NCT00358826|B4|Baseline|Placebo|Matching Placebo, oral dosing, 12 weeks
1180596|NCT00358826|B3|Baseline|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
1180597|NCT00358826|B2|Baseline|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
1180598|NCT00358826|B1|Baseline|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
1180599|NCT00358826|P8|Participant Flow|Placebo MDCT Substudy|Matching Placebo, 24 weeks
1180600|NCT00358826|P7|Participant Flow|VIA-2291 100 mg MDCT Substudy|VIA-2291, 100 mg, oral dosing, daily, 24 weeks
1180601|NCT00358826|P6|Participant Flow|VIA-2291 50 mg MDCT Substudy|VIA-2291, 50 mg, oral dosing, daily, 24 weeks
1180602|NCT00358826|P5|Participant Flow|VIA-2291 25 mg MDCT Substudy|VIA-2291, 25 mg, oral dosing, daily, 24 weeks
1180603|NCT00358826|P4|Participant Flow|Placebo|Matching Placebo, 12 weeks
1180604|NCT00358826|P3|Participant Flow|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
1180605|NCT00358826|P2|Participant Flow|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
1180606|NCT00358826|P1|Participant Flow|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
1180607|NCT00358826|O4|Outcome|Placebo|Matching Placebo, oral dosing, 12 weeks
1180608|NCT00358826|O3|Outcome|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
1180609|NCT00358826|O2|Outcome|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
1180610|NCT00358826|O1|Outcome|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
1180611|NCT00358826|O4|Outcome|Placebo|Matching Placebo, oral dosing, 12 weeks
1180612|NCT00358826|O3|Outcome|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
1180613|NCT00358826|O2|Outcome|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
1180614|NCT00358826|O1|Outcome|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
1180615|NCT00358826|O4|Outcome|Placebo MDCT Substudy|Matching Placebo, oral dosing, 24 weeks
1180616|NCT00358826|O3|Outcome|VIA-2291 100 mg MDCT Substudy|VIA-2291, 100 mg, oral dosing, daily, 24 weeks
1180617|NCT00358826|O2|Outcome|VIA-2291 50 mg MDCT Substudy|VIA-2291, 50 mg, oral dosing, daily, 24 weeks
1180618|NCT00358826|O1|Outcome|VIA-2291 25 mg MDCT Substudy|VIA-2291, 25 mg, oral dosing, daily, 24 weeks
1180619|NCT00358826|O4|Outcome|Placebo MDCT Substudy|Matching Placebo, oral dosing, 24 weeks
1180620|NCT00358826|O3|Outcome|VIA-2291 100 mg MDCT Substudy|VIA-2291, 100 mg, oral dosing, daily, 24 weeks
1180621|NCT00358826|O2|Outcome|VIA-2291 50 mg MDCT Substudy|VIA-2291, 50 mg, oral dosing, daily, 24 weeks
1180622|NCT00358826|O1|Outcome|VIA-2291 25 mg MDCT Substudy|VIA-2291, 25 mg, oral dosing, daily, 24 weeks
1180623|NCT00358826|O4|Outcome|Placebo|Matching Placebo, oral dosing, 12 weeks
1180624|NCT00358826|O3|Outcome|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
1180628|NCT00358826|O3|Outcome|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
1180629|NCT00358826|O2|Outcome|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
1180630|NCT00358826|O1|Outcome|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
1180631|NCT00358826|O4|Outcome|Placebo|Matching Placebo, oral dosing, 12 weeks
1180632|NCT00358826|O3|Outcome|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
1180633|NCT00358826|O2|Outcome|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
1180634|NCT00358826|O1|Outcome|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
1180635|NCT00358826|E4|Reported Event|Placebo|Matching Placebo, oral dosing, 12 weeks
1180636|NCT00358826|E3|Reported Event|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
1180641|NCT00358735|B1|Baseline|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
1180642|NCT00358735|P2|Participant Flow|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
1180643|NCT00358735|P1|Participant Flow|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
1180644|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
1180645|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
1180646|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
1180647|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
1180648|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
1180649|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
1180650|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
1180651|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
1180652|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
1180653|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
1180654|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
1180655|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
1180656|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
1180657|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
1180658|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
1180659|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
1195547|NCT00313144|O1|Outcome|Year Prior to Baseline|
1180660|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
1180661|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
1180662|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
1180663|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
1180664|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
1180665|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
1180666|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
1180667|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
1180668|NCT00358735|E2|Reported Event|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
1180669|NCT00358735|E1|Reported Event|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
1180670|NCT00358670|B3|Baseline|Total|Total of all reporting groups
1180671|NCT00358670|B2|Baseline|Intermittent Infliximab|Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in PASI from the Study P04271 (NCT00251641) Baseline
1180672|NCT00358670|B1|Baseline|Maintenance Infliximab|Infliximab 5 mg/kg by body weight every 8 weeks
1180673|NCT00358670|P2|Participant Flow|Intermittent Infliximab|Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in Psoriasis Area and Severity Index (PASI) from the Study P04271 (NCT00251641) Baseline
1180674|NCT00358670|P1|Participant Flow|Maintenance Infliximab|Infliximab 5 mg/kg by body weight every 8 weeks
1180675|NCT00358670|O2|Outcome|Intermittent Infliximab|Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in PASI from the Study P04271 (NCT00251641) Baseline
1180676|NCT00358670|O1|Outcome|Maintenance Infliximab|Infliximab 5 mg/kg by body weight every 8 weeks
1180677|NCT00358670|O2|Outcome|Intermittent Infliximab|Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in PASI from the Study P04271 (NCT00251641) Baseline
1180678|NCT00358670|O1|Outcome|Maintenance Infliximab|Infliximab 5 mg/kg by body weight every 8 weeks
1180679|NCT00358670|O2|Outcome|Intermittent Infliximab|Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in PASI from the Study P04271 (NCT00251641) Baseline
1180680|NCT00358670|O1|Outcome|Maintenance Infliximab|Infliximab 5 mg/kg by body weight every 8 weeks
1180681|NCT00358670|O2|Outcome|Intermittent Infliximab|Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in PASI from the Study P04271 (NCT00251641) Baseline
1180682|NCT00358670|O1|Outcome|Maintenance Infliximab|Infliximab 5 mg/kg by body weight every 8 weeks
1180683|NCT00358670|O2|Outcome|Intermittent Infliximab|Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in PASI from the Study P04271 (NCT00251641) Baseline
1180684|NCT00358670|O1|Outcome|Maintenance Infliximab|Infliximab 5 mg/kg by body weight every 8 weeks
1180685|NCT00358670|E2|Reported Event|Intermittent Infliximab|
1180686|NCT00358670|E1|Reported Event|Maintenance Infliximab|
1180687|NCT00358644|B1|Baseline|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 Intravenous on Days 1-5 of each 28 day cycle
1180688|NCT00358644|P1|Participant Flow|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 Intravenous on Days 1-5 of each 28 day cycle
1180689|NCT00358644|O1|Outcome|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 Intravenous on Days 1-5 of each 28 day cycle
1180690|NCT00358644|E1|Reported Event|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 Intravenous on Days 1-5 of each 28 day cycle
1180691|NCT00358579|B3|Baseline|Total|Total of all reporting groups
1180692|NCT00358579|B2|Baseline|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
1180693|NCT00358579|B1|Baseline|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
1180694|NCT00358579|P2|Participant Flow|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
1180695|NCT00358579|P1|Participant Flow|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
1180696|NCT00358579|O2|Outcome|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
1180697|NCT00358579|O1|Outcome|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
1180698|NCT00358579|O2|Outcome|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
1180699|NCT00358579|O1|Outcome|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
1180700|NCT00358579|O2|Outcome|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
1180701|NCT00358579|O1|Outcome|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
1180702|NCT00358579|O2|Outcome|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
1180703|NCT00358579|O1|Outcome|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
1180704|NCT00358579|O2|Outcome|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
1180705|NCT00358579|O1|Outcome|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
1181229|NCT00357370|O1|Outcome|Placebo|Tablets, oral, once daily for 12 weeks
1180706|NCT00358579|E2|Reported Event|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
1180707|NCT00358579|E1|Reported Event|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
1180708|NCT00358527|B3|Baseline|Total|Total of all reporting groups
1180709|NCT00358527|B2|Baseline|Placebo Nasal Spray.|Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
1180710|NCT00358527|B1|Baseline|Mometasone Furoate Nasal Spray|Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.
1180711|NCT00358527|P2|Participant Flow|Placebo Nasal Spray.|Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
1180712|NCT00358527|P1|Participant Flow|Mometasone Furoate Nasal Spray|Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.
1180713|NCT00358527|O2|Outcome|Placebo Nasal Spray.|Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
1180714|NCT00358527|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.
1180715|NCT00358527|O2|Outcome|Placebo Nasal Spray.|Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
1180716|NCT00358527|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.
1180717|NCT00358527|E2|Reported Event|Placebo Nasal Spray.|Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
1180718|NCT00358527|E1|Reported Event|Mometasone Furoate Nasal Spray|Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.
1180719|NCT00358501|B3|Baseline|Total|Total of all reporting groups
1180720|NCT00358501|B2|Baseline|Historical Control|The control group was selected from the historical medical charts of patients undergoing hematopoietic stem cell transplant (HSCT).
1180721|NCT00358501|B1|Baseline|Defibrotide|"Defibrotide treatment~Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days."
1180722|NCT00358501|P2|Participant Flow|Historical Control|The control group was selected from the historical medical charts of patients undergoing HSCT.
1180723|NCT00358501|P1|Participant Flow|Defibrotide|"Defibrotide treatment~Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days."
1180724|NCT00358501|O1|Outcome|Historical Control|
1180725|NCT00358501|O2|Outcome|Historical Control|The control group was selected from the historical medical charts of patients undergoing HSCT.
1180726|NCT00358501|O1|Outcome|Defibrotide|"Defibrotide treatment~Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days."
1180727|NCT00358501|O2|Outcome|Historical Control|The control group was selected from the historical medical charts of patients undergoing HSCT.
1180728|NCT00358501|O1|Outcome|Defibrotide|"Defibrotide treatment~Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days."
1180729|NCT00358501|O2|Outcome|Historical Control|The control group was selected from the historical medical charts of patients undergoing HSCT.
1180730|NCT00358501|O1|Outcome|Defibrotide|"Defibrotide treatment~Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days."
1180731|NCT00358501|O2|Outcome|Historical Control|The control group was selected from the historical medical charts of patients undergoing HSCT.
1180732|NCT00358501|O1|Outcome|Defibrotide|"Defibrotide treatment~Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days."
1180733|NCT00358501|E2|Reported Event|Historical Control|
1180734|NCT00358501|E1|Reported Event|Defibrotide|"Defibrotide treatment~Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days."
1180735|NCT00358462|B3|Baseline|Total|Total of all reporting groups
1180736|NCT00358462|B2|Baseline|Active Doxycycline + Placebo Azithromycin|Doxycycline : one 100mg capsule administered twice daily for seven days
1180737|NCT00358462|B1|Baseline|Active Azithromycin + Placebo Doxycycline|Azithromycin : two 500mg tablets or four 250mg tablets administered as a single dose
1180738|NCT00358462|P2|Participant Flow|Active Doxycycline + Placebo Azithromycin|Doxycycline : one 100mg capsule administered twice daily for seven days
1180739|NCT00358462|P1|Participant Flow|Active Azithromycin + Placebo Doxycycline|Azithromycin : two 500mg tablets or four 250mg tablets administered as a single dose
1180740|NCT00358462|O2|Outcome|Active Doxycycline + Placebo Azithromycin|Doxycycline : one 100mg capsule administered twice daily for seven days
1195548|NCT00313144|O5|Outcome|>18 Months to ≤24 Months|
1180741|NCT00358462|O1|Outcome|Active Azithromycin + Placebo Doxycycline|Azithromycin : two 500mg tablets or four 250mg tablets administered as a single dose
1180742|NCT00358462|O2|Outcome|Active Doxycycline + Placebo Azithromycin|Doxycycline : one 100mg capsule administered twice daily for seven days
1180743|NCT00358462|O1|Outcome|Active Azithromycin + Placebo Doxycycline|Azithromycin : two 500mg tablets or four 250mg tablets administered as a single dose
1180744|NCT00358462|E2|Reported Event|Active Doxycycline + Placebo Azithromycin|Doxycycline : one 100mg capsule administered twice daily for seven days
1180745|NCT00358462|E1|Reported Event|Active Azithromycin + Placebo Doxycycline|Azithromycin : two 500mg tablets or four 250mg tablets administered as a single dose
1180746|NCT00358449|B4|Baseline|Total|Total of all reporting groups
1180747|NCT00358449|B3|Baseline|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180748|NCT00358449|B2|Baseline|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180749|NCT00358449|B1|Baseline|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180751|NCT00358449|P2|Participant Flow|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180752|NCT00358449|P1|Participant Flow|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180753|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180754|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180755|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180756|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180757|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180758|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180759|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180760|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180761|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180762|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180763|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180764|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180765|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180766|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180767|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180768|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180769|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180770|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180771|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180772|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180773|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180774|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180775|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180776|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180777|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180778|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180779|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180780|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180781|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180782|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180783|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180784|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180785|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180786|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180787|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180788|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180789|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180790|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180791|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180792|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180793|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180794|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180795|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180796|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180797|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180798|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180799|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180800|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180801|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180802|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180803|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180804|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180805|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180806|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180807|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180808|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180809|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180810|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180811|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180812|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180813|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180814|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180815|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180816|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180817|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180818|NCT00358449|O1|Outcome|Mepolizumab 0.55/ 2.5/ 10 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180819|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180820|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180821|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180822|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180823|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180824|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180825|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180826|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180827|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180828|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1195549|NCT00313144|O4|Outcome|>12 Months to ≤18 Months|
1180829|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180830|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180831|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180832|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180833|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180834|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180835|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180836|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180837|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180838|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180839|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180840|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180841|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180842|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180843|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180844|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180845|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180846|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180847|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180848|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180849|NCT00358449|E3|Reported Event|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180850|NCT00358449|E2|Reported Event|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180851|NCT00358449|E1|Reported Event|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion for 30 minutes on Day 1, Week 4 and Week 8.
1180852|NCT00358436|B3|Baseline|Total|Total of all reporting groups
1180853|NCT00358436|B2|Baseline|Placebo|Placebo by inhalation
1180854|NCT00358436|B1|Baseline|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
1180855|NCT00358436|P2|Participant Flow|Placebo|Placebo by inhalation
1180856|NCT00358436|P1|Participant Flow|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
1180857|NCT00358436|O2|Outcome|Placebo|Once daily administered via inhalation
1180858|NCT00358436|O1|Outcome|Aclidinium 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
1180859|NCT00358436|O2|Outcome|Placebo|Placebo by inhalation
1180860|NCT00358436|O1|Outcome|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
1180861|NCT00358436|O2|Outcome|Placebo|Placebo by inhalation
1180862|NCT00358436|O1|Outcome|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
1180863|NCT00358436|O2|Outcome|Placebo|Placebo by inhalation
1180864|NCT00358436|O1|Outcome|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
1180865|NCT00358436|E2|Reported Event|Placebo|Placebo by inhalation
1180866|NCT00358436|E1|Reported Event|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
1180867|NCT00358332|B5|Baseline|Total|Total of all reporting groups
1180868|NCT00358332|B4|Baseline|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180869|NCT00358332|B3|Baseline|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180870|NCT00358332|B2|Baseline|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180871|NCT00358332|B1|Baseline|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180872|NCT00358332|P4|Participant Flow|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180873|NCT00358332|P3|Participant Flow|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180874|NCT00358332|P2|Participant Flow|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1181083|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
1180875|NCT00358332|P1|Participant Flow|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180876|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180877|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180878|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180879|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180880|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180881|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180882|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180883|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180884|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180885|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180886|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180887|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180888|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180889|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180890|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180891|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180892|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180893|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180894|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180895|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180896|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180897|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180898|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180899|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180900|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180901|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180902|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180903|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180904|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180905|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180906|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1181440|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
1180907|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180908|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180909|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180910|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180911|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180912|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180913|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180914|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180915|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180916|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180917|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180918|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180919|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180920|NCT00358332|E4|Reported Event|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180921|NCT00358332|E3|Reported Event|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180922|NCT00358332|E2|Reported Event|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180923|NCT00358332|E1|Reported Event|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
1180924|NCT00358215|B3|Baseline|Total|Total of all reporting groups
1180925|NCT00358215|B2|Baseline|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
1180926|NCT00358215|B1|Baseline|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
1180927|NCT00358215|P2|Participant Flow|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
1180928|NCT00358215|P1|Participant Flow|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
1180929|NCT00358215|O2|Outcome|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
1180930|NCT00358215|O1|Outcome|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
1180931|NCT00358215|O2|Outcome|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
1180932|NCT00358215|O1|Outcome|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
1180933|NCT00358215|O2|Outcome|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
1180934|NCT00358215|O1|Outcome|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
1180935|NCT00358215|O2|Outcome|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
1180936|NCT00358215|O1|Outcome|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
1180937|NCT00358215|O2|Outcome|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
1181164|NCT00357656|O4|Outcome|BI Stratum B|Participants who underwent hip surgery and were treated by bolus infusion
1180938|NCT00358215|O1|Outcome|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
1180939|NCT00358215|E2|Reported Event|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
1180940|NCT00358215|E1|Reported Event|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
1180941|NCT00358007|B1|Baseline|Cone Beam CT|Undergo a cone beam CT scan
1180942|NCT00358007|P1|Participant Flow|Cone Beam CT|Undergo a cone beam CT scan
1180943|NCT00358007|O1|Outcome|Cone Beam CT|PTV Reduction: The margin around the area to be treated with radiation is decreased due the image guidance of the cone beam CT
1180944|NCT00358007|O1|Outcome|Cone Beam CT|PTV Reduction: The margin around the area to be treated with radiation is decreased due the image guidance of the cone beam CT
1180945|NCT00358007|E1|Reported Event|Cone Beam CT|Undergo a cone beam CT scan
1180946|NCT00357994|B3|Baseline|Total|Total of all reporting groups
1181230|NCT00357370|O3|Outcome|Dapagliflozin 20 mg|Tablets, oral, once daily for 12 weeks
1180947|NCT00357994|B2|Baseline|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1180948|NCT00357994|B1|Baseline|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1180949|NCT00357994|P2|Participant Flow|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1180950|NCT00357994|P1|Participant Flow|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1180951|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1180952|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1180953|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1180954|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1180955|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1180956|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1180957|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1180958|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1180959|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1180960|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1180961|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1180962|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1181027|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
1180963|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1180964|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1180965|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1180966|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1180967|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1180968|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1180969|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1180970|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1180971|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1180972|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1180973|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1180974|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1180975|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1180976|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1180977|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1180978|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1180979|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1180980|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1180981|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1180982|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1180983|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1180984|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1180985|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1180986|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1180987|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1180988|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1180989|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1180990|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1180991|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1180992|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1180993|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1180994|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1180995|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1180996|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1180997|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1180998|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1180999|NCT00357994|E2|Reported Event|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
1181000|NCT00357994|E1|Reported Event|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
1181001|NCT00357968|B3|Baseline|Total|Total of all reporting groups
1181002|NCT00357968|B2|Baseline|Clopidogrel to Prasugrel|One time oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a once daily 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) for 14 days. Patients cross-over to a once daily 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for the next 14 days.
1181003|NCT00357968|B1|Baseline|Prasugrel to Clopidogrel|One time oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a once daily 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for 14 days. Patients cross-over to a once daily 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally for the next 14 days.
1181025|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days.
1181004|NCT00357968|P2|Participant Flow|Clopidogrel to Prasugrel|One time oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a once daily 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally for 14 days (Treatment 1 Phase). Patients cross-over to a once daily 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for the next 14 days (Treatment 2 Phase).
1181005|NCT00357968|P1|Participant Flow|Prasugrel to Clopidogrel|One time oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a once daily 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for 14 days (Treatment 1 Phase). Patients cross-over to a once daily 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally for the next 14 days (Treatment 2 Phase).
1181006|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days.
1181007|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days.
1181008|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to the administration of any maintenance dose.
1181009|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
1181010|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days.
1181011|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days.
1181012|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
1181013|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
1181014|NCT00357968|O2|Outcome|Clopidogrel|Includes total number of evaluable samples from patients who received clopidogrel in each maintenance dose period (52 from the first maintenance dose period and 51 from the second maintenance dose period).
1181015|NCT00357968|O1|Outcome|Prasugrel|Includes the total number of evaluable samples from patients who received prasugrel in each maintenance dose period (50 from the first maintenance dose period and 50 from the second maintenance dose period)
1181016|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days.
1181017|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days.
1181018|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) prior to any maintenance dose.
1181019|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) prior to any maintenance dose
1181020|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) prior to any maintenance dose.
1181021|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
1181022|NCT00357968|O2|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days. Patients crossed over to a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for the next 14 days.
1181023|NCT00357968|O1|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days. Patients crossed over to a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally for the next 14 days.
1181024|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days.
1181026|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to the administration of any maintenance dose.
1181028|NCT00357968|O2|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days. Patients crossed over to a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) for the next 14 days.
1181029|NCT00357968|O1|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days. Patients crossed over to a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) for the next 14 days.
1181030|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days.
1181231|NCT00357370|O2|Outcome|Dapagliflozin 10 mg|Tablets, oral, once daily for 12 weeks
1181031|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days.
1181032|NCT00357968|O2|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days. Patients crossed over to a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for the next 14 days.
1181033|NCT00357968|O1|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days. Patients crossed over to a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally for the next 14 days.
1181034|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days.
1181035|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days.
1181036|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
1181037|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
1181038|NCT00357968|O2|Outcome|Clopidogrel|Includes total number of evaluable samples from patients who received clopidogrel in each maintenance dose period (46 from the first maintenance dose period and 40 from the second maintenance dose period).
1181039|NCT00357968|O1|Outcome|Prasugrel|Includes total number of evaluable samples from patients who received prasugrel in each maintenance dose period (40 in the first maintenance period and 45 in the second maintenance period).
1181040|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to the administration of any maintenance dose.
1181041|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
1181042|NCT00357968|E4|Reported Event|Clopidogrel After Cross-over|Clopidogrel 150 mg and placebo matched to prasugrel (clopidogrel maintenance dose) once daily for 14 days after cross-over from one time loading dose of 60 mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by 10 mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) once daily for 14 days.
1181043|NCT00357968|E3|Reported Event|Prasugrel After Cross-over|Prasugrel 10 mg and placebo matched to clopidogrel (prasugrel maintenance dose)once daily for 14 days after cross-over from one time loading dose of clopidogrel 600 mg and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by clopidogrel 150 mg and placebo matched to prasugrel (clopidogrel maintenance dose) once daily for 14 days
1181044|NCT00357968|E2|Reported Event|Clopidogrel Before Cross-over|One time oral loading dose of 600 mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by 150 mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) once daily for 14 days.
1181045|NCT00357968|E1|Reported Event|Prasugrel Before Cross-over|One time oral loading dose (LD) of 60 mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by prasugrel 10 mg and placebo matched to clopidogrel (prasugrel maintenance dose) once daily for 14 days.
1181046|NCT00357955|B3|Baseline|Total|Total of all reporting groups
1181047|NCT00357955|B2|Baseline|Usual Care|usual care
1181048|NCT00357955|B1|Baseline|MEDIC|"Multidisciplinary education and diabetes intervention for cardiac risk reduction~Pharmacologic case management : provided by clinical pharmacists following pre-established algorithms~Behavioral counseling and peer support : Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention~Role modeling : learning from peers with similar disease and problems~Interactive Education : interactive lectures with hands-on learning"
1181049|NCT00357955|P2|Participant Flow|Usual Care|usual care
1181082|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
1181050|NCT00357955|P1|Participant Flow|MEDIC|"Multidisciplinary education and diabetes intervention for cardiac risk reduction~Pharmacologic case management : provided by clinical pharmacists following pre-established algorithms~Behavioral counseling and peer support : Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention~Role modeling : learning from peers with similar disease and problems~Interactive Education : interactive lectures with hands-on learning"
1181051|NCT00357955|O2|Outcome|Usual Care|The standard of care to patients with type 2 diabetes is provided by primary care providers at the VA Medical Center through individual clinic visits. The frequency of these visits for patients with diabetes averages approximately 4 months.usual care
1181052|NCT00357955|O1|Outcome|MEDIC|"Multidisciplinary education and diabetes intervention for cardiac risk reduction~Behavioral counseling and peer support: Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention~Interactive Education: interactive lectures with hands-on learning~Role modeling: learning from peers with similar disease and problems~Pharmacologic case management: provided by clinical pharmacists following pre-established algorithms"
1181054|NCT00357955|E1|Reported Event|MEDIC|"Multidisciplinary education and diabetes intervention for cardiac risk reduction~Behavioral counseling and peer support: Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention~Interactive Education: interactive lectures with hands-on learning~Role modeling: learning from peers with similar disease and problems~Pharmacologic case management: provided by clinical pharmacists following pre-established algorithms"
1181055|NCT00357903|B3|Baseline|Total|Total of all reporting groups
1181056|NCT00357903|B2|Baseline|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
1181057|NCT00357903|B1|Baseline|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
1181058|NCT00357903|P2|Participant Flow|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
1181059|NCT00357903|P1|Participant Flow|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
1181060|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
1181061|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
1181062|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
1181063|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
1181064|NCT00357903|O1|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
1181065|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
1181066|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
1181067|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
1181068|NCT00357903|O1|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
1181069|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
1181070|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
1181071|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
1181072|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
1181073|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
1181074|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
1181075|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
1181076|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
1181077|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
1181078|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
1181079|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
1181080|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
1181081|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
1181165|NCT00357656|O3|Outcome|BI Stratum A|Participants who underwent unilateral knee replacement and were treated by bolus infusion
1181084|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
1181085|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
1181086|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
1181087|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
1181088|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
1181089|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
1181177|NCT00357656|O7|Outcome|CI Stratum B|Participants who underwent hip surgery and were treated by continuous infusion
1181090|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
1181091|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
1181092|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
1181093|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
1181094|NCT00357903|E2|Reported Event|Pediatric Subjects|
1181095|NCT00357903|E1|Reported Event|Total Adults|
1181096|NCT00357877|B3|Baseline|Total|Total of all reporting groups
1181097|NCT00357877|B2|Baseline|Active Dental Coating|Dental coating with all ingredients including Chlorhexidine topically applied by dental professional supragingivally to the full dentition
1181098|NCT00357877|B1|Baseline|Placebo Dental Coating|Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition
1181099|NCT00357877|P2|Participant Flow|Active Dental Coating (CHX)|Dental coating with all ingredients including Chlorhexidine topically applied by dental professional supragingivally to the full dentition. 10% w/v chlorhexidine acetate coating FDA IND #45466.
1181100|NCT00357877|P1|Participant Flow|Placebo Dental Coating|Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition
1181101|NCT00357877|O2|Outcome|Active Dental Coating (CHX)|Dental coating with all ingredients including Chlorhexidine topically applied by dental professional supragingivally to the full dentition. 10% w/v chlorhexidine acetate coating FDA IND #45466.
1181102|NCT00357877|O1|Outcome|Placebo Dental Coating|Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition
1181103|NCT00357877|O2|Outcome|Active Dental Coating (CHX)|Dental coating with all ingredients including Chlorhexidine topically applied by dental professional supragingivally to the full dentition. 10% w/v chlorhexidine acetate coating FDA IND #45466.
1181104|NCT00357877|O1|Outcome|Placebo Dental Coating|Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition
1181105|NCT00357877|O2|Outcome|Active Dental Coating (CHX)|Dental coating with all ingredients including Chlorhexidine topically applied by dental professional supragingivally to the full dentition. 10% w/v chlorhexidine acetate coating FDA IND #45466.
1181106|NCT00357877|O1|Outcome|Placebo Dental Coating|Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition
1181107|NCT00357877|O2|Outcome|Active|Participants received a dental coating containing chlorhexidine diacetate (CHX) 10% weight per volume.
1181108|NCT00357877|O1|Outcome|Placebo|Participants received a placebo dental coating containing no chlorhexidine diacetate (CHX).
1181109|NCT00357877|E2|Reported Event|Active|Participants received a dental coating containing chlorhexidine diacetate (CHX) 10% weight per volume.
1181110|NCT00357877|E1|Reported Event|Placebo|Participants received a placebo dental coating containing no chlorhexidine diacetate (CHX).
1181111|NCT00357760|B3|Baseline|Total|Total of all reporting groups
1181112|NCT00357760|B2|Baseline|Arm B (Lower Dose of VEGF Trap)|Patients receive a lower dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, the dose of ziv-aflibercept (VEGF Trap) may be escalated to the higher dose in Arm A.
1181113|NCT00357760|B1|Baseline|Arm A (Higher Dose of VEGF Trap)|Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
1181114|NCT00357760|P2|Participant Flow|Arm B (Lower Dose of VEGF Trap)|Patients receive a lower dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, the dose of ziv-aflibercept (VEGF Trap) may be escalated to the higher dose in Arm A.
1181115|NCT00357760|P1|Participant Flow|Arm A (Higher Dose of VEGF Trap)|Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
1181116|NCT00357760|O2|Outcome|Arm B (Lower Dose of VEGF Trap)|Patients receive a lower dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, the dose of ziv-aflibercept (VEGF Trap) may be escalated to the higher dose in Arm A.
1181117|NCT00357760|O1|Outcome|Arm A (Higher Dose of VEGF Trap)|Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
1181166|NCT00357656|O2|Outcome|Continuous Infusion|Continuous infusion of ADVATE (rAHF-PFM)
1181167|NCT00357656|O1|Outcome|Bolus Infusion|Bolus infusion of ADVATE (rAHF-PFM)
1181441|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
1181118|NCT00357760|O2|Outcome|Arm B (Lower Dose of VEGF Trap)|Patients receive a lower dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, the dose of ziv-aflibercept (VEGF Trap) may be escalated to the higher dose in Arm A.
1181119|NCT00357760|O1|Outcome|Arm A (Higher Dose of VEGF Trap)|Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
1181120|NCT00357760|O2|Outcome|Arm B (Lower Dose of VEGF Trap)|Patients receive a lower dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, the dose of ziv-aflibercept (VEGF Trap) may be escalated to the higher dose in Arm A.
1181176|NCT00357656|O8|Outcome|CI Stratum C|Participants who underwent shoulder/elbow/ankle/knee (except knee replacement) surgery and were treated by continuous infusion
1181121|NCT00357760|O1|Outcome|Arm A (Higher Dose of VEGF Trap)|Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
1181122|NCT00357760|E2|Reported Event|Arm B (Lower Dose of VEGF Trap)|Patients receive a lower dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. In both arms, courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, the dose of ziv-aflibercept (VEGF Trap) may be escalated to the higher dose in Arm A.
1181123|NCT00357760|E1|Reported Event|Arm A (Higher Dose of VEGF Trap)|Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
1181124|NCT00357734|B1|Baseline|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
1181125|NCT00357734|P1|Participant Flow|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
1181126|NCT00357734|O1|Outcome|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
1181127|NCT00357734|O1|Outcome|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
1181128|NCT00357734|O1|Outcome|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
1181129|NCT00357734|O1|Outcome|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
1181130|NCT00357734|O1|Outcome|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
1181131|NCT00357734|O1|Outcome|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
1181132|NCT00357734|E1|Reported Event|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
1181133|NCT00357656|B3|Baseline|Total|Total of all reporting groups
1181134|NCT00357656|B2|Baseline|Continuous Infusion|Continuous infusion of ADVATE (rAHF-PFM)
1181135|NCT00357656|B1|Baseline|Bolus Infusion|Bolus infusion of ADVATE (rAHF-PFM)
1181136|NCT00357656|P2|Participant Flow|Continuous Infusion|Continuous infusion of ADVATE (rAHF-PFM)
1181137|NCT00357656|P1|Participant Flow|Bolus Infusion|Bolus infusion of ADVATE (rAHF-PFM)
1181138|NCT00357656|O3|Outcome|Safety Analysis Set|All participants treated with at least one ADVATE (rAHF-PFM) dose
1181139|NCT00357656|O2|Outcome|Continuous Infusion|Continuous infusion of ADVATE (rAHF-PFM)
1181140|NCT00357656|O1|Outcome|Bolus Infusion|Bolus infusion of ADVATE (rAHF-PFM)
1181141|NCT00357656|O3|Outcome|Safety Analysis Set|All participants treated with at least one ADVATE (rAHF-PFM) dose.
1181142|NCT00357656|O2|Outcome|Continuous Infusion|Continuous infusion of ADVATE (rAHF-PFM)
1181143|NCT00357656|O1|Outcome|Bolus Infusion|Bolus infusion of ADVATE (rAHF-PFM)
1181144|NCT00357656|O8|Outcome|CI Stratum C|Participants who underwent shoulder/elbow/ankle/knee (except knee replacement) surgery and were treated by continuous infusion
1181145|NCT00357656|O7|Outcome|CI Stratum B|Participants who underwent hip surgery and were treated by continuous infusion
1181146|NCT00357656|O6|Outcome|CI Stratum A|Participants who underwent unilateral knee replacement and were treated by continuous infusion
1181147|NCT00357656|O5|Outcome|BI Stratum C|Participants who underwent shoulder/elbow/ankle/knee (except knee replacement) surgery and were treated by bolus infusion
1181148|NCT00357656|O4|Outcome|BI Stratum B|Participants who underwent hip surgery and were treated by bolus infusion
1181149|NCT00357656|O3|Outcome|BI Stratum A|Participants who underwent unilateral knee replacement and were treated by bolus infusion
1181150|NCT00357656|O2|Outcome|Continuous Infusion|Continuous infusion of ADVATE (rAHF-PFM)
1181151|NCT00357656|O1|Outcome|Bolus Infusion|Bolus infusion of ADVATE (rAHF-PFM)
1181152|NCT00357656|O8|Outcome|CI Stratum C|Participants who underwent shoulder/elbow/ankle/knee (except knee replacement) surgery and were treated by continuous infusion
1181153|NCT00357656|O7|Outcome|CI Stratum B|Participants who underwent hip surgery and were treated by continuous infusion
1181154|NCT00357656|O6|Outcome|CI Stratum A|Participants who underwent unilateral knee replacement and were treated by continuous infusion
1181155|NCT00357656|O5|Outcome|BI Stratum C|Participants who underwent shoulder/elbow/ankle/knee (except knee replacement) surgery and were treated by bolus infusion
1181156|NCT00357656|O4|Outcome|BI Stratum B|Participants who underwent hip surgery and were treated by bolus infusion
1181157|NCT00357656|O3|Outcome|BI Stratum A|Participants who underwent unilateral knee replacement and were treated by bolus infusion
1181158|NCT00357656|O2|Outcome|Continuous Infusion|Continuous infusion of rAHF-PFM
1181159|NCT00357656|O1|Outcome|Bolus Infusion|Bolus infusion of rAHF-PFM
1181160|NCT00357656|O8|Outcome|CI Stratum C|Participants who underwent shoulder/elbow/ankle/knee (except knee replacement) surgery and were treated by continuous infusion
1181161|NCT00357656|O7|Outcome|CI Stratum B|Participants who underwent hip surgery and were treated by continuous infusion
1181162|NCT00357656|O6|Outcome|CI Stratum A|Participants who underwent unilateral knee replacement and were treated by continuous infusion
1181163|NCT00357656|O5|Outcome|BI Stratum C|Participants who underwent shoulder/elbow/ankle/knee (except knee replacement) surgery and were treated by bolus infusion
1181442|NCT00356590|E1|Reported Event|Enbrel|
1181168|NCT00357656|O8|Outcome|CI Stratum C|Participants who underwent shoulder/elbow/ankle/knee (except knee replacement) surgery and were treated by continuous infusion
1181169|NCT00357656|O7|Outcome|CI Stratum B|Participants who underwent hip surgery and were treated by continuous infusion
1181170|NCT00357656|O6|Outcome|CI Stratum A|Participants who underwent unilateral knee replacement and were treated by continuous infusion
1181171|NCT00357656|O5|Outcome|BI Stratum C|Participants who underwent shoulder/elbow/ankle/knee (except knee replacement) surgery and were treated by bolus infusion
1181172|NCT00357656|O4|Outcome|BI Stratum B|Participants who underwent hip surgery and were treated by bolus infusion
1181173|NCT00357656|O3|Outcome|BI Stratum A|Participants who underwent unilateral knee replacement and were treated by bolus infusion
1181174|NCT00357656|O2|Outcome|Contiuous Infusion|Continuous infusion of ADVATE (rAHF-PFM)
1181178|NCT00357656|O6|Outcome|CI Stratum A|Participants who underwent unilateral knee replacement and were treated by continuous infusion
1181179|NCT00357656|O5|Outcome|BI Stratum C|Participants who underwent shoulder/elbow/ankle/knee (except knee replacement) surgery and were treated by bolus infusion
1181180|NCT00357656|O4|Outcome|BI Stratum B|Participants who underwent hip surgery and were treated by bolus infusion
1181181|NCT00357656|O3|Outcome|BI Stratum A|Participants who underwent unilateral knee replacement and were treated by bolus infusion
1181182|NCT00357656|O2|Outcome|Continuous Infusion|Continuous infusion of ADVATE (rAHF-PFM)
1181183|NCT00357656|O1|Outcome|Bolus Infusion|Bolus infusion of ADVATE (rAHF-PFM)
1181184|NCT00357656|E3|Reported Event|Not Assigned Participants|All participants who were not assigned to either bolus infusion or continuous infusion but received at least one ADVATE (rAHF-PFM) dose during pharmacokinetic evaluation. A total of 9 participants received only the pharmacokinetic infusion and were not randomized.
1181185|NCT00357656|E2|Reported Event|Continuous Infusion|All participants who were randomized to receive continuous infusion (CI) of ADVATE (rAHF-PFM). At total of 32 participants were randomized and received at least one ADVATE (rAHF-PFM) dose.
1181186|NCT00357656|E1|Reported Event|Bolus Infusion|All participants who were randomized to receive bolus infusion (BI) of ADVATE (rAHF-PFM). At total of 31 participants were randomized and received at least one ADVATE (rAHF-PFM) dose.
1181187|NCT00357552|B1|Baseline|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
1181188|NCT00357552|P1|Participant Flow|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
1181189|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
1181190|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
1181191|NCT00357552|O1|Outcome|LPV/r Monotherapy|"Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) once a day will be added to their regimen.~Emtricitabine/Tenofovir disoproxil fumarate: Once daily~Lopinavir/Ritonavir: Twice daily"
1181192|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
1181193|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
1181194|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen. The study is ongoing. Results from entry to week 24 are posted. They will be updated upon completion of study duration of 104 weeks.
1181195|NCT00357552|O1|Outcome|Virologic Failures by Week 24.|Subjects who met virologic failure criteria by week 24, for whom a sequence could be obtained.
1181196|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
1181197|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
1181198|NCT00357552|O1|Outcome|All Screened Subjects With Available Sequences|All screened individuals, for whom a sequence could be obtained, regardless of whether they enrolled or not.
1181199|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
1181200|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
1181201|NCT00357552|E1|Reported Event|LPV/r|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
1181214|NCT00357396|O1|Outcome|Patients With HIGH RISK EWING'S SARCOMA FAMILY TUMOR|MELPHALAN & THIOTEPA TREATMENT OF HIGH RISK EWING'S SARCOMA FAMILY TUMOR
1181215|NCT00357396|E2|Reported Event|Related Donors|Any consenting healthy family donor who is HLA compatible with the recipient will be considered as a potential donor for transplant
1181202|NCT00357500|B1|Baseline|5-drug Metronmic Antiangiogenic Regimen|Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
1181224|NCT00357370|O3|Outcome|Dapagliflozin 20 mg|Tablets, oral, once daily for 12 weeks
1181225|NCT00357370|O2|Outcome|Dapagliflozin 10 mg|Tablets, oral, once daily for 12 weeks
1181226|NCT00357370|O1|Outcome|Placebo|Tablets, oral, once daily for 12 weeks
1181227|NCT00357370|O3|Outcome|Dapagliflozin 20 mg|Tablets, oral, once daily for 12 weeks
1181228|NCT00357370|O2|Outcome|Dapagliflozin 10 mg|Tablets, oral, once daily for 12 weeks
1181203|NCT00357500|P1|Participant Flow|5-drug Metronomic Antiangiogenic Regimen|Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
1181204|NCT00357500|O1|Outcome|5-drug Metronomic Antiangiogenic Regimen|Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
1181205|NCT00357500|O1|Outcome|5-drug Metronomic Antiangiogenic Regimen|Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
1181206|NCT00357500|O1|Outcome|5-drug Metronomic Antiangiogenic Regimen|Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
1181207|NCT00357500|O1|Outcome|5-drug Metronomic Antiangiogenic Regimen|Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
1181208|NCT00357500|E1|Reported Event|5-drug Metronomic Antiangiogenic Regimen|Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
1181209|NCT00357396|B3|Baseline|Total|Total of all reporting groups
1181210|NCT00357396|B2|Baseline|Related Donors|Any consenting healthy family donor who is HLA compatible with the recipient will be considered as a potential donor for transplant
1181211|NCT00357396|B1|Baseline|Patients With HIGH RISK EWING'S SARCOMA FAMILY TUMOR|MELPHALAN & THIOTEPA TREATMENT OF HIGH RISK EWING'S SARCOMA FAMILY TUMOR
1181212|NCT00357396|P2|Participant Flow|Related Donors|Any consenting healthy family donor who is HLA compatible with the recipient will be considered as a potential donor for transplant
1181213|NCT00357396|P1|Participant Flow|Patients With HIGH RISK EWING'S SARCOMA FAMILY TUMOR|MELPHALAN & THIOTEPA TREATMENT OF HIGH RISK EWING'S SARCOMA FAMILY TUMOR
1181437|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
1181216|NCT00357396|E1|Reported Event|Patients With HIGH RISK EWING'S SARCOMA FAMILY TUMOR|MELPHALAN & THIOTEPA TREATMENT OF HIGH RISK EWING'S SARCOMA FAMILY TUMOR
1181217|NCT00357370|B4|Baseline|Total|Total of all reporting groups
1181218|NCT00357370|B3|Baseline|Dapagliflozin 10 mg|Tablets, oral, once daily for 12 weeks
1181219|NCT00357370|B2|Baseline|Placebo|Tablets, oral, once daily for 12 weeks
1181220|NCT00357370|B1|Baseline|Dapagliflozin 20 mg|Tablets, oral, once daily for 12 weeks
1181221|NCT00357370|P3|Participant Flow|Dapagliflozin 10 mg|Tablets, oral, once daily for 12 weeks
1181222|NCT00357370|P2|Participant Flow|Placebo|Tablets, oral, once daily for 12 weeks
1181223|NCT00357370|P1|Participant Flow|Dapagliflozin 20 mg|Tablets, oral, once daily for 12 weeks
1181232|NCT00357370|O1|Outcome|Placebo|Tablets, oral, once daily for 12 weeks
1181233|NCT00357370|O3|Outcome|Dapagliflozin 20 mg|Tablets, oral, once daily for 12 weeks
1181234|NCT00357370|O2|Outcome|Dapagliflozin 10 mg|Tablets, oral, once daily for 12 weeks
1181235|NCT00357370|O1|Outcome|Placebo|Tablets, oral, once daily for 12 weeks
1181236|NCT00357370|O3|Outcome|Dapagliflozin 20 mg|Tablets, oral, once daily for 12 weeks
1181237|NCT00357370|O2|Outcome|Dapagliflozin 10 mg|Tablets, oral, once daily for 12 weeks
1181238|NCT00357370|O1|Outcome|Placebo|Tablets, oral, once daily for 12 weeks
1181239|NCT00357370|O3|Outcome|Dapagliflozin 20 mg|Tablets, oral, once daily for 12 weeks
1181240|NCT00357370|O2|Outcome|Dapagliflozin 10 mg|Tablets, oral, once daily for 12 weeks
1181241|NCT00357370|O1|Outcome|Placebo|Tablets, oral, once daily for 12 weeks
1181242|NCT00357370|E3|Reported Event|Dapagliflozin 10 mg|Tablets, oral, once daily for 12 weeks
1181243|NCT00357370|E2|Reported Event|Placebo|Tablets, oral, once daily for 12 weeks
1181244|NCT00357370|E1|Reported Event|Dapagliflozin 20 mg|Tablets, oral, once daily for 12 weeks
1181245|NCT00357331|B3|Baseline|Total|Total of all reporting groups
1181246|NCT00357331|B2|Baseline|Potassium Citrate|
1181247|NCT00357331|B1|Baseline|Placebo|
1181248|NCT00357331|P2|Participant Flow|Placebo|"Placebo~Placebo 20 meq by mouth in capsule form twice daily"
1181249|NCT00357331|P1|Participant Flow|Potassium Citrate|"Potassium Citrate 20 meq twice daily~potassium citrate: 20 meq by mouth in capsule form twice daily"
1181250|NCT00357331|O2|Outcome|Potassium Citrate|
1181251|NCT00357331|O1|Outcome|Placebo|
1181252|NCT00357331|O2|Outcome|Potassium Citrate|
1181253|NCT00357331|O1|Outcome|Placebo|
1181254|NCT00357331|O2|Outcome|Potassium Citrate|
1181255|NCT00357331|O1|Outcome|Placebo|
1181256|NCT00357331|E2|Reported Event|Placebo|"Placebo~potassium citrate: 20 meq by mouth in capsule form twice daily"
1181257|NCT00357331|E1|Reported Event|Potassium Citrate|"Potassium Citrate 20 meq twice daily~potassium citrate: 20 meq by mouth in capsule form twice daily"
1181258|NCT00357162|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
1181259|NCT00357162|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
1181260|NCT00357162|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
1181261|NCT00357162|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
1181262|NCT00357162|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
1181263|NCT00357162|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
1181264|NCT00357162|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
1181265|NCT00357162|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
1181266|NCT00357110|B3|Baseline|Total|Total of all reporting groups
1181267|NCT00357110|B2|Baseline|Anastrozole|anastrozole 1 mg
1181268|NCT00357110|B1|Baseline|Fulvestrant + Anastrozole|fulvestrant 500 mg + anastrozole 1 mg
1181269|NCT00357110|P2|Participant Flow|Anastrozole|anastrozole 1 mg
1181270|NCT00357110|P1|Participant Flow|Fulvestrant + Anastrozole|fulvestrant 500 mg + anastrozole 1 mg
1181271|NCT00357110|O2|Outcome|Anastrozole|anastrozole 1 mg
1181272|NCT00357110|O1|Outcome|Fulvestrant + Anastrozole|fulvestrant 500 mg + anastrozole 1 mg
1181273|NCT00357110|E2|Reported Event|Anastrozole|anastrozole 1 mg
1181274|NCT00357110|E1|Reported Event|Fulvestrant + Anastrozole|fulvestrant 500 mg + anastrozole 1 mg
1181275|NCT00357097|B3|Baseline|Total|Total of all reporting groups
1181276|NCT00357097|B2|Baseline|Placebo|Subjects who took no investigational product.
1181443|NCT00356525|B5|Baseline|Total|Total of all reporting groups
1181277|NCT00357097|B1|Baseline|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
1181278|NCT00357097|P2|Participant Flow|Placebo|Subjects who took no investigational product.
1181279|NCT00357097|P1|Participant Flow|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
1181280|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
1181281|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
1181282|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
1181283|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
1181284|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
1181285|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
1181286|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
1181287|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
1181288|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
1181289|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
1181290|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
1181291|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
1181292|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
1181293|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
1181294|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
1181295|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
1181296|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
1181297|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
1181298|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
1181299|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
1181300|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
1181301|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
1181302|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
1181303|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
1181304|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
1181305|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
1181306|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
1181307|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
1181308|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
1181309|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
1181310|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
1181311|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
1181312|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
1181313|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
1181314|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
1181315|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
1181316|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
1181438|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
1181317|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
1181318|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
1181319|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
1181320|NCT00357097|E2|Reported Event|Placebo|Subjects who took no investigational product.
1181321|NCT00357097|E1|Reported Event|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
1181322|NCT00357032|B1|Baseline|Treatment (Belinostat)|"Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
1181323|NCT00357032|P1|Participant Flow|Treatment (Belinostat)|"Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
1181512|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
1181324|NCT00357032|O1|Outcome|Treatment (Belinostat)|"Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
1181325|NCT00357032|O1|Outcome|Treatment (Belinostat)|"Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
1181326|NCT00357032|E1|Reported Event|Treatment (Belinostat)|"Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
1181327|NCT00357006|B4|Baseline|Total|Total of all reporting groups
1181328|NCT00357006|B3|Baseline|Placebo|
1181329|NCT00357006|B2|Baseline|Adjunctive 100 mcg Transdermal Estradiol|
1181330|NCT00357006|B1|Baseline|Adjunctive 200 mcg Transdermal Estradiol|
1181331|NCT00357006|P3|Participant Flow|Placebo|Participants received daily transdermal placebo for 56 days.
1181332|NCT00357006|P2|Participant Flow|Adjunctive 100 mcg Transdermal Estradiol|Participants received daily 100mcg transdermal estradiol for 56 days.
1181333|NCT00357006|P1|Participant Flow|Adjunctive 200 mcg Transdermal Estradiol|Participants received daily 200mcg transdermal estradiol for 56 days.
1181334|NCT00357006|O3|Outcome|Placebo|Participants received daily transdermal placebo for 56 days.
1181335|NCT00357006|O2|Outcome|Adjunctive 100 mcg Transdermal Estradiol|Participants received daily 100 mcg transdermal estradiol for 56 days.
1181336|NCT00357006|O1|Outcome|Adjunctive 200 mcg Transdermal Estradiol|Participants received daily 200 mcg transdermal estradiol for 56 days.
1181337|NCT00357006|E3|Reported Event|Placebo|Participants received daily transdermal placebo for 8 weeks (56 days).
1181338|NCT00357006|E2|Reported Event|Adjunctive 100 mcg Transdermal Estradiol|Participants received daily 100mcg transdermal estradiol for 8 weeks (56 days).
1181339|NCT00357006|E1|Reported Event|Adjunctive 200 mcg Transdermal Estradiol|Participants received daily 200mcg transdermal estradiol for 8 weeks (56 days).
1181340|NCT00356915|B4|Baseline|Total|Total of all reporting groups
1181341|NCT00356915|B3|Baseline|Placebo Tablets|Tablets that were the same as the Itraconazole tables except that they did not contain the active drug (Itraconazole).
1181342|NCT00356915|B2|Baseline|Itraconazole Capsules|Itraconazole 100 mg capsules
1181343|NCT00356915|B1|Baseline|Itraconazole Tablets|Itraconazole 200 mg tablets. Subjects took one 200 mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit.
1181344|NCT00356915|P3|Participant Flow|Placebo Tablets|Tablets that were the same as the Itraconazole tables except that they did not contain the active drug (Itraconazole).
1181345|NCT00356915|P2|Participant Flow|Itraconazole Capsules|Itraconazole 100 mg capsules
1181346|NCT00356915|P1|Participant Flow|Itraconazole Tablets|Itraconazole 200 mg tablets. Subjects took one 200 mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit.
1181347|NCT00356915|O2|Outcome|Placebo Tablets|
1181348|NCT00356915|O1|Outcome|Itraconazole Tablets|Itraconazole 200mg tablets
1181349|NCT00356915|O2|Outcome|Itraconazole Capsules|Itraconazole 100mg capsules
1181350|NCT00356915|O1|Outcome|Itraconazole Tablets|Itraconazole 200mg tablets
1181351|NCT00356915|O3|Outcome|Placebo Tablets|Tablets that were the same as the Itraconazole tables except that they did not contain the active drug (Itraconazole).
1181352|NCT00356915|O2|Outcome|Itraconazole Capsules|Itraconazole 100 mg capsules
1181353|NCT00356915|O1|Outcome|Itraconazole Tablets|Itraconazole 200 mg tablets. Subjects took one 200 mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit.
1181354|NCT00356915|O2|Outcome|Placebo Tablets|
1181355|NCT00356915|O1|Outcome|Itraconazole Tablets|Itraconazole 200mg tablets
1181356|NCT00356915|E6|Reported Event|Placebo Tablets - Follow-up Period|Adverse events that occurred during the follow-up (no treatment) period are reported here.
1181357|NCT00356915|E5|Reported Event|Itraconazole Capsules - Follow-up Period|Adverse events that occurred during the follow-up (no treatment) period are reported here.
1181358|NCT00356915|E4|Reported Event|Itraconazole Tablets - Follow-up Period|Adverse events that occurred during the follow-up (no treatment) period are reported here.
1181359|NCT00356915|E3|Reported Event|Placebo Tablets|Adverse events that occurred during the Treatment Period are reported here.
1181360|NCT00356915|E2|Reported Event|Itraconazole Capsules|Itraconazole 100mg capsules Adverse events that occurred during the Treatment Period are reported here.
1181361|NCT00356915|E1|Reported Event|Itraconazole Tablets - Treatment Period|Itraconazole 200mg tablets Adverse events that occurred during the Treatment Period are reported here.
1181439|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
1181362|NCT00356889|B1|Baseline|Bevacizumab and Erlotinib Hydrochloride|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. Tumor tissue and blood specimens are collected periodically for correlative studies. Specimens are examined by immunohistochemistry for epidermal growth factor receptor (EGFR) and P-EGFR protein levels; AKT p-AKT, mitogen-activated protein kinase (MAPK) and P-MAPK protein levels; and vascular endothelial growth factor receptor (VEGFR)-1 and VEGFR-2 protein levels. EGFR mutations are detected by laser capture microdissection. Enzyme-linked immunosorbent assay is used to measure total and free serum VEGF levels.
1181363|NCT00356889|P1|Participant Flow|Bevacizumab and Erlotinib Hydrochloride|"Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~Tumor tissue and blood specimens are collected periodically for correlative studies. Specimens are examined by immunohistochemistry for epidermal growth factor receptor (EGFR) and P-EGFR protein levels; AKT p-AKT, mitogen-activated protein kinase (MAPK) and P-MAPK protein levels; and vascular endothelial growth factor receptor (VEGFR)-1 and VEGFR-2 protein levels. EGFR mutations are detected by laser capture microdissection. Enzyme-linked immunosorbent assay is used to measure total and free serum VEGF levels."
1181364|NCT00356889|O1|Outcome|Bevacizumab and Erlotinib Hydrochloride|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
1181365|NCT00356889|O1|Outcome|Bevacizumab and Erlotinib Hydrochloride|"Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~Tumor tissue and blood specimens are collected periodically for correlative studies. Specimens are examined by immunohistochemistry for epidermal growth factor receptor (EGFR) and P-EGFR protein levels; AKT p-AKT, mitogen-activated protein kinase (MAPK) and P-MAPK protein levels; and vascular endothelial growth factor receptor (VEGFR)-1 and VEGFR-2 protein levels. EGFR mutations are detected by laser capture microdissection. Enzyme-linked immunosorbent assay is used to measure total and free serum VEGF levels."
1181366|NCT00356889|O1|Outcome|Bevacizumab and Erlotinib Hydrochloride|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
1181367|NCT00356889|O1|Outcome|Bevacizumab and Erlotinib Hydrochloride|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
1181368|NCT00356889|E1|Reported Event|Bevacizumab and Erlotinib Hydrochloride|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. Tumor tissue and blood specimens are collected periodically for correlative studies. Specimens are examined by immunohistochemistry for epidermal growth factor receptor (EGFR) and P-EGFR protein levels; AKT p-AKT, mitogen-activated protein kinase (MAPK) and P-MAPK protein levels; and vascular endothelial growth factor receptor (VEGFR)-1 and VEGFR-2 protein levels. EGFR mutations are detected by laser capture microdissection. Enzyme-linked immunosorbent assay is used to measure total and free serum VEGF levels.
1181369|NCT00356863|B3|Baseline|Total|Total of all reporting groups
1181370|NCT00356863|B2|Baseline|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
1181371|NCT00356863|B1|Baseline|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
1181372|NCT00356863|P2|Participant Flow|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
1181373|NCT00356863|P1|Participant Flow|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
1181374|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
1181375|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
1181376|NCT00356863|O2|Outcome|No Education (Control) About Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
1181377|NCT00356863|O1|Outcome|Educational (Intervention) on Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
1181378|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
1181379|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
1181380|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
1181381|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
1181382|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
1190876|NCT00325897|O1|Outcome|Azithromycin|Azithromycin 250 mg
1181383|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
1181384|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
1181385|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
1181386|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
1181387|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
1181388|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
1181389|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
1181390|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
1181391|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
1181392|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
1181393|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
1181394|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about CR and were giving the usual care.
1181395|NCT00356863|O1|Outcome|Education (Intervention) on Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
1181396|NCT00356863|E2|Reported Event|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
1181397|NCT00356863|E1|Reported Event|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
1181398|NCT00356811|B1|Baseline|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1181399|NCT00356811|P1|Participant Flow|Lapatinib With Paclitaxel|Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel, administered as a 1-hour intravenous (IV) infusion at a dose of 80 mg/meters squared (m^2) on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1181400|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1181401|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1181402|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1181403|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1181404|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1181405|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1181406|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1181407|NCT00356811|O1|Outcome|Overall Study Arm|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1181408|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1181409|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1181410|NCT00356811|E1|Reported Event|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1181411|NCT00356590|B1|Baseline|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
1181412|NCT00356590|P1|Participant Flow|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
1181413|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
1181414|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
1181415|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
1181416|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
1181417|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
1181418|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
1181419|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
1181420|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
1181421|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
1181422|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
1181423|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
1181424|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
1181425|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
1181426|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
1181427|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
1181428|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
1181429|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
1181430|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
1181431|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
1181432|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
1181433|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
1181434|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
1181435|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
1181436|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
1195550|NCT00313144|O3|Outcome|>6 Months to ≤12 Months|
1181444|NCT00356525|B4|Baseline|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
1181445|NCT00356525|B3|Baseline|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
1181446|NCT00356525|B2|Baseline|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
1181447|NCT00356525|B1|Baseline|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
1181513|NCT00356421|E2|Reported Event|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
1181448|NCT00356525|P4|Participant Flow|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
1181449|NCT00356525|P3|Participant Flow|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
1181450|NCT00356525|P2|Participant Flow|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
1181451|NCT00356525|P1|Participant Flow|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
1181452|NCT00356525|O4|Outcome|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
1181453|NCT00356525|O3|Outcome|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
1181454|NCT00356525|O2|Outcome|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
1181455|NCT00356525|O1|Outcome|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
1181456|NCT00356525|O4|Outcome|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
1181457|NCT00356525|O3|Outcome|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
1181458|NCT00356525|O2|Outcome|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
1181459|NCT00356525|O1|Outcome|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
1181460|NCT00356525|O4|Outcome|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
1181461|NCT00356525|O3|Outcome|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
1181462|NCT00356525|O2|Outcome|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
1181463|NCT00356525|O1|Outcome|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
1181464|NCT00356525|O4|Outcome|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
1181465|NCT00356525|O3|Outcome|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
1181503|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
1181832|NCT00355472|O3|Outcome|KW-0761 0.5mg|IV infusions of KW-0761 once/week for 4 weeks
1181466|NCT00356525|O2|Outcome|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
1181467|NCT00356525|O1|Outcome|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
1181468|NCT00356525|O4|Outcome|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
1181469|NCT00356525|O3|Outcome|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
1181470|NCT00356525|O2|Outcome|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
1181471|NCT00356525|O1|Outcome|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
1181472|NCT00356525|E4|Reported Event|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
1181473|NCT00356525|E3|Reported Event|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
1181474|NCT00356525|E2|Reported Event|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
1181475|NCT00356525|E1|Reported Event|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
1181476|NCT00356421|B3|Baseline|Total|Total of all reporting groups
1181477|NCT00356421|B2|Baseline|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
1181478|NCT00356421|B1|Baseline|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
1181479|NCT00356421|P2|Participant Flow|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
1181480|NCT00356421|P1|Participant Flow|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
1181481|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
1181482|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
1181483|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
1181484|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
1181485|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
1181486|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
1181487|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
1181488|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
1181489|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
1181490|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
1181491|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
1181492|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
1181493|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
1181494|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
1181495|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
1181496|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
1181497|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
1181498|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
1181499|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
1181500|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
1181501|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
1181502|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
1195551|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
1181504|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
1181505|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
1181506|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
1181507|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
1181508|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
1181509|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
1181510|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
1181511|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
1181514|NCT00356421|E1|Reported Event|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
1181515|NCT00356408|B5|Baseline|Total|Total of all reporting groups
1181516|NCT00356408|B4|Baseline|CDP870/Non-completer|CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
1181517|NCT00356408|B3|Baseline|Placebo/Non-completer|Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
1181518|NCT00356408|B2|Baseline|CDP870/Completer|CDP870 Completer: CDP870 subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
1181519|NCT00356408|B1|Baseline|Placebo/Completer|Placebo Completer: Placebo subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
1181520|NCT00356408|P1|Participant Flow|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg (2 injections of 1 mL) every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn’s disease indication in the patient’s country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2
1181521|NCT00356408|O4|Outcome|CDP870/Non-completer|CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
1181522|NCT00356408|O3|Outcome|Placebo/Non-completer|Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
1181523|NCT00356408|O2|Outcome|CDP870/Completer|CDP870 Completer: CDP870 subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
1181524|NCT00356408|O1|Outcome|Placebo/Completer|Placebo Completer: Placebo subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
1181525|NCT00356408|O4|Outcome|CDP870/Non-completer|CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
1181526|NCT00356408|O3|Outcome|Placebo/Non-completer|Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
1181527|NCT00356408|O2|Outcome|CDP870/Completer|CDP870 Completer: CDP870 subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
1181528|NCT00356408|O1|Outcome|Placebo/Completer|Placebo Completer: Placebo subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
1181529|NCT00356408|E5|Reported Event|CDP870 400 mg (Overall)|Certolizumab pegol (CDP870) 400 mg (2 injections of 1 mL) every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn’s disease indication in the patient’s country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2
1181530|NCT00356408|E4|Reported Event|CDP870/Non-completer|CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
1181531|NCT00356408|E3|Reported Event|Placebo/Non-completer|Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
1181532|NCT00356408|E2|Reported Event|CDP870/Completer|CDP870 Completer: CDP870 subjects who completed C87059. Whatever their remission status and steroids use, they have participated to the week 38 visit of C87059.
1181533|NCT00356408|E1|Reported Event|Placebo/Completer|Placebo Completer: Placebo subjects who completed C87059. Whatever their remission status and steroids use, they have participated to the week 38 visit of C87059.
1181534|NCT00356304|B3|Baseline|Total|Total of all reporting groups
1181535|NCT00356304|B2|Baseline|Treatment as Usual|Participants in this condition received usual care provided at the bilingual division of the CMHC. This included medication management, as well as some psychotherapy treatment. All aspects of care for participants in TAU was naturalistic and determined by CMHC psychiatrists and therapists who were not part of the study.
1181536|NCT00356304|B1|Baseline|Motivational Enhancement Therapy for Antidepressants|Participants in this condition received TAU that was enhanced with three sessions of META. Two sessions were provided between the time 1 and time 2 evaluations, with a booster session occurring between the time 2 and time 3 evaluations. These participants were also receiving psychopharmacologic/psychotherapeutic care that was naturalistic.
1181603|NCT00356148|P2|Participant Flow|No Prophylaxis Group|Patients who are BMI over 25 and do not receive antibiotic prophylaxis
1181537|NCT00356304|P2|Participant Flow|Treatment as Usual|Participants in this condition received usual care provided at the bilingual division of the CMHC. This included medication management, as well as some psychotherapy treatment. All aspects of care for participants in TAU was naturalistic and determined by CMHC psychiatrists and therapists who were not part of the study.
1181538|NCT00356304|P1|Participant Flow|Motivational Enhancement Therapy for Antidepressants|Participants in this condition received TAU that was enhanced with three sessions of META. Two sessions were provided between the time 1 and time 2 evaluations, with a booster session occurring between the time 2 and time 3 evaluations. These participants were also receiving psychopharmacologic/psychotherapeutic care that was naturalistic.
1181539|NCT00356304|O2|Outcome|Treatment as Usual|
1181540|NCT00356304|O1|Outcome|Motivational Enhancement Therapy for Antidepressants|
1181541|NCT00356304|O2|Outcome|Treatment as Usual|
1181542|NCT00356304|O1|Outcome|Motivational Enhancement Therapy for Antidepressants|
1181543|NCT00356304|E2|Reported Event|Treatment as Usual|Participants in this condition received usual care provided at the bilingual division of the CMHC. This included medication management, as well as some psychotherapy treatment. All aspects of care for participants in TAU was naturalistic and determined by CMHC psychiatrists and therapists who were not part of the study.
1181544|NCT00356304|E1|Reported Event|Motivational Enhancement Therapy for Antidepressants|Participants in this condition received TAU that was enhanced with three sessions of META. Two sessions were provided between the time 1 and time 2 evaluations, with a booster session occurring between the time 2 and time 3 evaluations. These participants were also receiving psychopharmacologic/psychotherapeutic care that was naturalistic.
1181545|NCT00356278|B4|Baseline|Total|Total of all reporting groups
1181546|NCT00356278|B3|Baseline|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
1181547|NCT00356278|B2|Baseline|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
1181548|NCT00356278|B1|Baseline|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
1181549|NCT00356278|P3|Participant Flow|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
1181550|NCT00356278|P2|Participant Flow|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
1181551|NCT00356278|P1|Participant Flow|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
1181552|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
1181553|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
1181554|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
1181555|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
1181556|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
1181557|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
1181833|NCT00355472|O2|Outcome|KW-0761 0.1mg|IV infusions of KW-0761 once/week for 4 weeks
1181558|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
1181559|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
1181560|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
1181754|NCT00355706|O1|Outcome|Group I - Without Steroids|Thoracic medial branch blocks with local anesthetics
1190877|NCT00325897|E2|Reported Event|Placebo|Inactive sugar pill
1181561|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
1181562|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
1181563|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
1181564|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
1181565|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
1181566|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
1181567|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
1181568|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
1181569|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
1181570|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
1181571|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
1181572|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
1181573|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
1181574|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
1181575|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
1181576|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
1181577|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
1181578|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
1181579|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
1181580|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
1181581|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
1181582|NCT00356278|E3|Reported Event|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
1181583|NCT00356278|E2|Reported Event|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
1181584|NCT00356278|E1|Reported Event|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
1181585|NCT00356200|B3|Baseline|Total|Total of all reporting groups
1181586|NCT00356200|B2|Baseline|Cohort 2: 100 ug/ml Fluphenazine Decanoate|Receiving fluphenazine decanoate (100 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body
1181587|NCT00356200|B1|Baseline|Cohort 1: 10 ug/ml Fluphenazine Decanoate|Receiving fluphenazine decanoate (10 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body
1181588|NCT00356200|P2|Participant Flow|Cohort 2: 100 ug/ml Fluphenazine Decanoate|Receiving fluphenazine decanoate (100 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body.
1181589|NCT00356200|P1|Participant Flow|Cohort 1: 10 ug/ml Fluphenazine Decanoate|Receiving fluphenazine decanoate (10 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body.
1181590|NCT00356200|O4|Outcome|Cohort 2, Placebo Treated Lesion|Cohort 2 lesion treated with placebo
1181591|NCT00356200|O3|Outcome|Cohort 2, 100 ug/ml Fluphenazine Treated Lesion|Cohort 2 100 ug/ml Fluphenazine decanoate treated lesion
1181592|NCT00356200|O2|Outcome|Cohort 1, Placebo Treated Lesion|Cohort 1 lesion treated with placebo
1181593|NCT00356200|O1|Outcome|Cohort 1, 10 ug/ml Fluphenazine Treated Lesion|Cohort 1 10 ug/ml Fluphenazine decanoate treated lesion
1181594|NCT00356200|O4|Outcome|Cohort 2, Placebo Treated Lesion|lesion treated with placebo (Cohort 2)
1181595|NCT00356200|O3|Outcome|Cohort 2, 100 ug/ml Fluphenazine Treated Lesion|lesion receiving 100 ug/ml Fluphenazine decanoate (Cohort 2)
1181596|NCT00356200|O2|Outcome|Cohort 1, Placebo Treated Lesion|lesion treated with placebo (Cohort 1)
1181597|NCT00356200|O1|Outcome|Cohort 1, 10 ug/ml Fluphenazine Treated Lesion|lesion receiving 10 ug/ml Fluphenazine decanoate (Cohort 1)
1181598|NCT00356200|E2|Reported Event|Cohort 2: 100 ug/ml Fluphenazine Decanoate|Receiving fluphenazine decanoate (100 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body
1181599|NCT00356200|E1|Reported Event|Cohort 1: 10 ug/ml Fluphenazine Decanoate|Receiving fluphenazine decanoate (10 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body
1181600|NCT00356148|B3|Baseline|Total|Total of all reporting groups
1181601|NCT00356148|B2|Baseline|No Prophylaxis Group|Patients who are BMI over 25 and do not receive antibiotic prophylaxis
1181602|NCT00356148|B1|Baseline|Prophylaxis Group|patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis
1195552|NCT00313144|O1|Outcome|Year Prior to Baseline|
1181604|NCT00356148|P1|Participant Flow|Prophylaxis Group|patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis
1181605|NCT00356148|O2|Outcome|No Prophylaxis Group|Patients who are BMI over 25 and not receiving antibiotic prophylaxis
1181606|NCT00356148|O1|Outcome|Prophylaxis Group|patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis
1181607|NCT00356148|O2|Outcome|No Prophylaxis Group|Patients who are BMI over 25 and not receive antibiotic prophylaxis
1181608|NCT00356148|O1|Outcome|Prophylaxis Group|patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis
1181609|NCT00356148|E2|Reported Event|No Prophylaxis Group|Patients who are BMI over 25 and do not receive antibiotic prophylaxis
1181610|NCT00356148|E1|Reported Event|Prophylaxis Group|patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis
1181611|NCT00356135|B4|Baseline|Total|Total of all reporting groups
1181755|NCT00355706|O2|Outcome|Group II - With Steroids|Thoracic medial branch blocks with bupivacaine and steroid
1181756|NCT00355706|O1|Outcome|Group I - Without Steroids|Thoracic medial branch blocks with local anesthetics
1181612|NCT00356135|B3|Baseline|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
1181613|NCT00356135|B2|Baseline|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
1181614|NCT00356135|B1|Baseline|Prasugrel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
1181615|NCT00356135|P3|Participant Flow|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
1181616|NCT00356135|P2|Participant Flow|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
1181617|NCT00356135|P1|Participant Flow|Prasgurel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
1181618|NCT00356135|O3|Outcome|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
1181619|NCT00356135|O2|Outcome|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
1181620|NCT00356135|O1|Outcome|Prasugrel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
1181621|NCT00356135|O3|Outcome|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
1181622|NCT00356135|O2|Outcome|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
1181623|NCT00356135|O1|Outcome|Prasugrel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
1181624|NCT00356135|O3|Outcome|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
1181625|NCT00356135|O2|Outcome|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
1181626|NCT00356135|O1|Outcome|Prasugrel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
1181627|NCT00356135|O2|Outcome|No Clopidogrel Use|Patients with no clopidogrel use at the time of qualifying ACS event.
1181628|NCT00356135|O1|Outcome|Clopidogrel Use|Patients with clopidogrel use at the time of qualifying ACS event.
1181629|NCT00356135|O3|Outcome|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
1181630|NCT00356135|O2|Outcome|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
1181631|NCT00356135|O1|Outcome|Prasugrel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
1181632|NCT00356135|O3|Outcome|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
1181633|NCT00356135|O2|Outcome|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
1181634|NCT00356135|O1|Outcome|Prasugrel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
1181635|NCT00356135|E3|Reported Event|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
1181636|NCT00356135|E2|Reported Event|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
1181637|NCT00356135|E1|Reported Event|Prasgurel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
1181638|NCT00356122|B1|Baseline|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of~70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,~100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,~15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
1181845|NCT00355472|O2|Outcome|KW-0761 0.1mg|IV infusions of KW-0761 once/week for 4 weeks
1181639|NCT00356122|P1|Participant Flow|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of~70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,~100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,~15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
1181640|NCT00356122|O1|Outcome|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of~70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,~100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,~15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
1181641|NCT00356122|O1|Outcome|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of~70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,~100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,~15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
1181642|NCT00356122|O1|Outcome|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of~70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,~100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,~15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
1181643|NCT00356122|O1|Outcome|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of~70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,~100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,~15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
1181644|NCT00356122|O1|Outcome|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of~70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,~100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,~15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
1181645|NCT00356122|E1|Reported Event|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of~70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,~100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,~15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
1181646|NCT00356057|B4|Baseline|Total|Total of all reporting groups
1181647|NCT00356057|B3|Baseline|RV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The device is programmed to right ventricular pacing only. The acceleromer is activated for rate adaptation.
1181648|NCT00356057|B2|Baseline|biV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The acceleromer is activated for rate adaptation.
1181649|NCT00356057|B1|Baseline|biV-pacing With CLS Rate Adaption (Protos CLS)|Patients are implanted with a Protos CLS device, using the atrial port of the device for the left ventricular lead and the ventricular port for the ventricular lead to provide biV pacing. CLS is activated for rate adaptation.
1181650|NCT00356057|P3|Participant Flow|RV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The device is programmed to right ventricular pacing only. The acceleromer is activated for rate adaptation.
1181651|NCT00356057|P2|Participant Flow|biV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The acceleromer is activated for rate adaptation.
1181652|NCT00356057|P1|Participant Flow|biV-pacing With CLS Rate Adaption (Protos CLS)|Patients are implanted with a Protos CLS device, using the atrial port of the device for the left ventricular lead and the ventricular port for the ventricular lead to provide biV pacing. CLS is activated for rate adaptation.
1181653|NCT00356057|O3|Outcome|RV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The device is programmed to right ventricular pacing only. The acceleromer is activated for rate adaptation.
1181654|NCT00356057|O2|Outcome|biV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The acceleromer is activated for rate adaptation.
1181655|NCT00356057|O1|Outcome|biV-pacing With CLS Rate Adaption (Protos CLS)|Patients are implanted with a Protos CLS device, using the atrial port of the device for the left ventricular lead and the ventricular port for the ventricular lead to provide biV pacing. CLS is activated for rate adaptation.
1181656|NCT00356057|E1|Reported Event|All Groups|
1181701|NCT00355797|O1|Outcome|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
1181657|NCT00356031|B1|Baseline|Bevacizumab, Radiation, and Surgery|"Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)~Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses~Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.~Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy."
1181658|NCT00356031|P1|Participant Flow|Experimental: Bevacizumab, Radiation, and Surgery|"Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)~Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses~Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.~Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy."
1181659|NCT00356031|O1|Outcome|Experimental: Bevacizumab, Radiation, and Surgery|"Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)~Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses~Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.~Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy."
1181660|NCT00356031|O1|Outcome|Experimental: Bevacizumab, Radiation, and Surgery|"Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)~Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses~Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.~Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy."
1181661|NCT00356031|O1|Outcome|Bevacizumab, Radiation, and Surgery|"Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)~Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses~Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.~Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy."
1181662|NCT00356031|O1|Outcome|Bevacizumab, Radiation, and Surgery|"Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)~Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses~Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.~Surgery: Surgical resection is performed 6-7 weeks after completion of neoadjuvant therapy."
1181663|NCT00356031|O1|Outcome|Bevacizumab, Radiation, and Surgery|"Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)~Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses~Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.~Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy."
1181702|NCT00355797|O3|Outcome|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
1181703|NCT00355797|O2|Outcome|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
1181704|NCT00355797|O1|Outcome|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
1181705|NCT00355797|O3|Outcome|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
1181706|NCT00355797|O2|Outcome|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
1181664|NCT00356031|O1|Outcome|Bevacizumab, Radiation, and Surgery|"Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)~Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses~Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.~Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy."
1181665|NCT00356031|E1|Reported Event|Bevacizumab, Radiation, and Surgery|"Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)~Bevacizumab: Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses~Radiation Therapy: External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.~Surgery: Surgery is performed 6-7 weeks after completion of neoadjuvant therapy."
1181666|NCT00355914|B3|Baseline|Total|Total of all reporting groups
1181667|NCT00355914|B2|Baseline|Group II With Steroids|Lumbar Facet Joint Nerve Blocks Local anesthetic with steroids
1181668|NCT00355914|B1|Baseline|Group 1 Without Steroids|Lumbar Facet Joint Nerve Blocks Local anesthetic without steroids
1181669|NCT00355914|P2|Participant Flow|Group II With Steroids|Lumbar Facet Joint block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and Steroids (0.15 mg of non-particulate betamethasone)
1181670|NCT00355914|P1|Participant Flow|Group 1 Without Steroids|Lumbar Facet Joint block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
1181671|NCT00355914|O2|Outcome|Group II With Steroids|Facet Joint Nerve Blocks Local anesthetic with steroids
1181672|NCT00355914|O1|Outcome|Group 1 Without Steroids|Lumbar Facet Joint Nerve Blocks Local anesthetic without steroids
1181673|NCT00355914|O2|Outcome|Group II|Local anesthetic with steroids
1181674|NCT00355914|O1|Outcome|Group I|Local anesthetic without steroids
1181675|NCT00355914|E2|Reported Event|Group II With Steroids|Facet Joint Nerve Blocks Local anesthetic with steroids
1181676|NCT00355914|E1|Reported Event|Group 1 Without Steroids|Lumbar Facet Joint Nerve Blocks Local anesthetic without steroids
1181677|NCT00355797|B4|Baseline|Total|Total of all reporting groups
1181678|NCT00355797|B3|Baseline|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
1181679|NCT00355797|B2|Baseline|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
1181680|NCT00355797|B1|Baseline|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
1181681|NCT00355797|P3|Participant Flow|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
1181682|NCT00355797|P2|Participant Flow|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
1181683|NCT00355797|P1|Participant Flow|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
1181684|NCT00355797|O3|Outcome|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
1181685|NCT00355797|O2|Outcome|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
1181686|NCT00355797|O1|Outcome|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
1181687|NCT00355797|O3|Outcome|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
1181688|NCT00355797|O2|Outcome|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
1181689|NCT00355797|O1|Outcome|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
1181690|NCT00355797|O3|Outcome|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
1181691|NCT00355797|O2|Outcome|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
1181692|NCT00355797|O1|Outcome|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
1181693|NCT00355797|O3|Outcome|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
1181694|NCT00355797|O2|Outcome|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
1181695|NCT00355797|O1|Outcome|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
1181696|NCT00355797|O3|Outcome|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
1181697|NCT00355797|O2|Outcome|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
1181698|NCT00355797|O1|Outcome|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
1181699|NCT00355797|O3|Outcome|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
1181700|NCT00355797|O2|Outcome|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
1195553|NCT00313144|O5|Outcome|>18 Months to ≤24 Months|
1181707|NCT00355797|O1|Outcome|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
1181708|NCT00355797|E3|Reported Event|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
1181709|NCT00355797|E2|Reported Event|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
1181710|NCT00355797|E1|Reported Event|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
1181711|NCT00355784|B4|Baseline|Total|Total of all reporting groups
1181846|NCT00355472|O1|Outcome|KW-0761 0.01mg|IV infusions of KW-0761 once/week for 4 weeks
1181712|NCT00355784|B3|Baseline|High Growth Hormone Treatment|5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received a relatively high daily dose of growth hormone.
1181713|NCT00355784|B2|Baseline|Growth Hormone Treatment|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
1181714|NCT00355784|B1|Baseline|Control|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
1181715|NCT00355784|P3|Participant Flow|High Growth Hormone Treatment|5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
1181716|NCT00355784|P2|Participant Flow|Growth Hormone Treatment|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
1181717|NCT00355784|P1|Participant Flow|Control|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
1181718|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|
1181719|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
1181720|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
1181721|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|
1181722|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
1181723|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
1181724|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|
1181725|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
1181726|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
1181727|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
1181728|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
1181729|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
1195554|NCT00313144|O4|Outcome|>12 Months to ≤18 Months|
1181730|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
1181757|NCT00355706|O2|Outcome|Group II With Steroid|Thoracic Facet Joint Nerve Blocks with Local Anesthetic (0.25% Bupivacaine) and Steroids (0.15 mg of non-particulate betamethasone)
1181758|NCT00355706|O1|Outcome|Group I Without Steroids|Thoracic Facet Joint Nerve Blocks with Local Anesthetic (0.25% Bupivacaine)
1181731|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
1181732|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
1181733|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|
1181734|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
1181735|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
1181736|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
1181737|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
1181738|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
1181739|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|
1181740|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
1181741|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
1181742|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
1181743|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
1181744|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
1181745|NCT00355784|E3|Reported Event|High Growth Hormone Treatment (High-GHT)|5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
1181746|NCT00355784|E2|Reported Event|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
1181747|NCT00355784|E1|Reported Event|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
1181748|NCT00355706|B3|Baseline|Total|Total of all reporting groups
1181749|NCT00355706|B2|Baseline|Group II - With Bupivacaine and Steroid|Group II - Thoracic medial branch blocks with bupivacaine and steroid
1181750|NCT00355706|B1|Baseline|Group I - With Local Anesthetics|Group I - Thoracic medial branch blocks with local anesthetics
1195555|NCT00313144|O3|Outcome|>6 Months to ≤12 Months|
1181751|NCT00355706|P2|Participant Flow|Group II - With Steroids|Group II - Thoracic medial branch blocks with bupivacaine and steroid
1181752|NCT00355706|P1|Participant Flow|Group I - Without Steroids|Group I - Thoracic medial branch blocks with local anesthetics
1181753|NCT00355706|O2|Outcome|Group II - With Steroids|Thoracic medial branch blocks with bupivacaine and steroid
1181759|NCT00355706|E2|Reported Event|Group II - With Bupivacaine and Steroid|Group II - Thoracic medial branch blocks with bupivacaine and steroid
1181760|NCT00355706|E1|Reported Event|Group I - With Local Anesthetics|Group I - Thoracic medial branch blocks with local anesthetics
1181761|NCT00355615|B5|Baseline|Total|Total of all reporting groups
1181762|NCT00355615|B4|Baseline|Placebo|placebo
1181763|NCT00355615|B3|Baseline|Rosuva 20|rosuvastatin 20 mg
1181764|NCT00355615|B2|Baseline|Rosuva 10|rosuvastatin 10 mg
1181765|NCT00355615|B1|Baseline|Rosuva 5|rosuvastatin 5 mg
1181766|NCT00355615|P5|Participant Flow|Rosuva ol|rosuvastatin open label
1181767|NCT00355615|P4|Participant Flow|Placebo|placebo
1181768|NCT00355615|P3|Participant Flow|Rosuva 20|rosuvastatin 20 mg
1181769|NCT00355615|P2|Participant Flow|Rosuva 10|rosuvastatin 10 mg
1181770|NCT00355615|P1|Participant Flow|Rosuva 5|rosuvastatin 5 mg
1181771|NCT00355615|O4|Outcome|Placebo|placebo
1181772|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
1181773|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
1181774|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
1181775|NCT00355615|O4|Outcome|Placebo|placebo
1181776|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
1181777|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
1181778|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
1181779|NCT00355615|O4|Outcome|Placebo|placebo
1181780|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
1181781|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
1181782|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
1181783|NCT00355615|O4|Outcome|Placebo|placebo
1181784|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
1181785|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
1181786|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
1181787|NCT00355615|O4|Outcome|Placebo|placebo
1181788|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
1181789|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
1181790|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
1181791|NCT00355615|O4|Outcome|Placebo|placebo
1181792|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
1181793|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
1181794|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
1181795|NCT00355615|O4|Outcome|Placebo|placebo
1181796|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
1181797|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
1181798|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
1181799|NCT00355615|O4|Outcome|Placebo|placebo
1181800|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
1181801|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
1181802|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
1181803|NCT00355615|O4|Outcome|Placebo|placebo
1181804|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
1181805|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
1181806|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
1181807|NCT00355615|O4|Outcome|Placebo|placebo
1181808|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
1181809|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
1181810|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
1181811|NCT00355615|O4|Outcome|Placebo|placebo
1181812|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
1181813|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
1181814|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
1181815|NCT00355615|O4|Outcome|Placebo|placebo
1181816|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
1181817|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
1181818|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
1181819|NCT00355615|O4|Outcome|Placebo|placebo
1181820|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
1181821|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
1181822|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
1181823|NCT00355615|E5|Reported Event|Rosuva ol|rosuvastatin open label
1181824|NCT00355615|E4|Reported Event|Placebo|placebo
1181825|NCT00355615|E3|Reported Event|Rosuva 20|rosuvastatin 20 mg
1181826|NCT00355615|E2|Reported Event|Rosuva 10|rosuvastatin 10 mg
1181827|NCT00355615|E1|Reported Event|Rosuva 5|rosuvastatin 5 mg
1181828|NCT00355472|B1|Baseline|KW-0761|KW-0761 was administered 4 times at one-week intervals at a dose of 0.01, 0.1, 0.5 or 1.0 mg/kg in patients with CCR4 positive ATL or CCR4 positive PTCL
1181829|NCT00355472|P1|Participant Flow|KW-0761|KW-0761 was administered 4 times at one-week intervals at a dose of 0.01, 0.1, 0.5 or 1.0 mg/kg in patients with CC chemokine 4 receptor (CCR4) positive Adult T-Cell Leukemia-Lymphoma (ATL) or CCR4 positive Peripheral T-Cell Lymphoma (PTCL)
1181830|NCT00355472|O1|Outcome|KW-0761|KW-0761 was administered 4 times at one-week intervals at a dose of 0.01, 0.1, 0.5 or 1.0 mg/kg in patients with CCR4 positive ATL or CCR4 positive PTCL.
1181831|NCT00355472|O4|Outcome|KW-0761 1.0mg|IV infusions of KW-0761 once/week for 4 weeks
1181834|NCT00355472|O1|Outcome|KW-0761 0.01mg|IV infusions of KW-0761 once/week for 4 weeks
1181835|NCT00355472|O4|Outcome|KW-0761 1.0mg|IV infusions of KW-0761 once/week for 4 weeks
1181836|NCT00355472|O3|Outcome|KW-0761 0.5mg|IV infusions of KW-0761 once/week for 4 weeks
1181837|NCT00355472|O2|Outcome|KW-0761 0.1mg|IV infusions of KW-0761 once/week for 4 weeks
1181838|NCT00355472|O1|Outcome|KW-0761 0.01mg|IV infusions of KW-0761 once/week for 4 weeks
1181839|NCT00355472|O4|Outcome|KW-0761 1.0mg|IV infusions of KW-0761 once/week for 4 weeks
1181840|NCT00355472|O3|Outcome|KW-0761 0.5mg|IV infusions of KW-0761 once/week for 4 weeks
1181841|NCT00355472|O2|Outcome|KW-0761 0.1mg|IV infusions of KW-0761 once/week for 4 weeks
1181842|NCT00355472|O1|Outcome|KW-0761 0.01mg|IV infusions of KW-0761 once/week for 4 weeks
1181843|NCT00355472|O4|Outcome|KW-0761 1.0mg|IV infusions of KW-0761 once/week for 4 weeks
1181844|NCT00355472|O3|Outcome|KW-0761 0.5mg|IV infusions of KW-0761 once/week for 4 weeks
1181847|NCT00355472|O1|Outcome|KW-0761|KW-0761 was administered 4 times at one-week intervals at a dose of 0.01, 0.1, 0.5 or 1.0 mg/kg in patients with CCR4 positive ATL or CCR4 positive PTCL
1181848|NCT00355472|O1|Outcome|KW-0761|KW-0761 was administered 4 times at one-week intervals at a dose of 0.01, 0.1, 0.5 or 1.0 mg/kg in patients with CCR4 positive ATL or CCR4 positive PTCL
1181849|NCT00355472|E4|Reported Event|KW-0761 1.0mg|IV infusions of KW-0761 once/week for 4 weeks
1181850|NCT00355472|E3|Reported Event|KW-0761 0.5mg|IV infusions of KW-0761 once/week for 4 weeks
1181851|NCT00355472|E2|Reported Event|KW-0761 0.1mg|IV infusions of KW-0761 once/week for 4 weeks
1181852|NCT00355472|E1|Reported Event|KW-0761 0.01mg|IV infusions of KW-0761 once/week for 4 weeks
1181853|NCT00355394|B3|Baseline|Total|Total of all reporting groups
1181854|NCT00355394|B2|Baseline|Metoclopramide|Metoclopramide group received standard care including IVF AND metoclopramide.
1181855|NCT00355394|B1|Baseline|Placebo|Placebo group received standard care including IVF but not metoclopramide.
1181856|NCT00355394|P2|Participant Flow|Metoclopramide|Metoclopramide group received standard care including IVF and also IV metoclopramide.
1181857|NCT00355394|P1|Participant Flow|Placebo|Placebo group received standard care including IVF but not metoclopramide.
1181858|NCT00355394|O2|Outcome|Metoclopramide|Metoclopramide group received standard care including IVF and also IV metoclopramide.
1181859|NCT00355394|O1|Outcome|Placebo|Placebo group received standard care including IVF but not metoclopramide.
1181860|NCT00355394|O2|Outcome|Metoclopramide|Metoclopramide group received standard care including IVF and also IV metoclopramide.
1181861|NCT00355394|O1|Outcome|Placebo|Placebo group received standard care including IVF but not metoclopramide.
1181862|NCT00355394|O2|Outcome|Metoclopramide|Metoclopramide group received standard care including IVF and also IV metoclopramide.
1181863|NCT00355394|O1|Outcome|Placebo|Placebo group received standard care including IVF but not metoclopramide.
1181864|NCT00355394|O2|Outcome|Metoclopramide|Metoclopramide group received standard care including IVF and also IV metoclopramide.
1181865|NCT00355394|O1|Outcome|Placebo|Placebo group received standard care including IVF but not metoclopramide.
1181866|NCT00355394|O2|Outcome|Metoclopramide|Metoclopramide
1181867|NCT00355394|O1|Outcome|Placebo|Placebo
1181868|NCT00355394|O2|Outcome|Metoclopramide|Metoclopramide
1181869|NCT00355394|O1|Outcome|Placebo|Placebo
1181870|NCT00355394|E2|Reported Event|Metoclopramide|Metoclopramide group received standard care including IVF and also IV metoclopramide.
1181871|NCT00355394|E1|Reported Event|Placebo|Placebo group received standard care including IVF but not metoclopramide.
1181872|NCT00355368|B3|Baseline|Total|Total of all reporting groups
1181873|NCT00355368|B2|Baseline|Rocuronium|0.6mg/kg
1181874|NCT00355368|B1|Baseline|Succinylcholine|1mg/kg
1181875|NCT00355368|P2|Participant Flow|Rocuronium|0.6mg/kg
1181876|NCT00355368|P1|Participant Flow|Succinylcholine|1mg/kg
1181877|NCT00355368|O2|Outcome|Rocuronium|
1181878|NCT00355368|O1|Outcome|Succinylcholine|
1181879|NCT00355368|O2|Outcome|Rocuronium|
1181880|NCT00355368|O1|Outcome|Succinylcholine|
1181881|NCT00355368|O2|Outcome|Rocuronium|
1181882|NCT00355368|O1|Outcome|Succinylcholine|
1181883|NCT00355368|O2|Outcome|Rocuronium|
1181884|NCT00355368|O1|Outcome|Succinylcholine|
1181885|NCT00355368|E2|Reported Event|Rocuronium|0.6mg/kg
1181886|NCT00355368|E1|Reported Event|Succinylcholine|1mg/kg
1181887|NCT00355147|B3|Baseline|Total|Total of all reporting groups
1181888|NCT00355147|B2|Baseline|Attention Control Group|Received Phone Calls from Staff to Control for Attention
1181889|NCT00355147|B1|Baseline|Arm 1 Stroke Self Management and Risk Factor Program|"Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support~Physician stroke guideline adherence: Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors~Secondary Stroke Self-Management and Risk Factor Management: Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/Transcient Ischemic Attack"
1181890|NCT00355147|P2|Participant Flow|Arm 2 Control Group|Received usual care, follow up telephone calls to control for contact, and educational materials
1181891|NCT00355147|P1|Participant Flow|Arm 1 Stroke Prevention Intervention|Randomized to receive the intervention which included receipt of stroke prevention and self management intervention and stroke peer support.
1181892|NCT00355147|O2|Outcome|Attention Control Group|Received Phone Calls from Staff to Control for Attention
1181935|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
1181893|NCT00355147|O1|Outcome|Arm 1 Stroke Self Management and Risk Factor Program|"Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support~Physician stroke guideline adherence: Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors~Secondary Stroke Self-Management and Risk Factor Management: Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/Transcient Ischemic Attack"
1181894|NCT00355147|O2|Outcome|Arm 2 Control Group|Received usual care, follow up telephone calls to control for contact, and educational materials
1181895|NCT00355147|O1|Outcome|Arm 1 Stroke Prevention Intervention|Randomized to receive the intervention which included receipt of stroke prevention and self management intervention and stroke peer support.
1181896|NCT00355147|O2|Outcome|Attention Control Group|Received Phone Calls from Staff to Control for Attention
1182057|NCT00354770|O1|Outcome|N-Acetyl Cysteine|N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day
1181897|NCT00355147|O1|Outcome|Arm 1 Secondary Risk Factor Management|"Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support and Physician Stroke Guideline Adherence~Physician stroke guideline adherence: Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors~Stroke Self Management: Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/TIA"
1181898|NCT00355147|O2|Outcome|Attention Control Group|Received Phone Calls from Staff to Control for Attention
1181899|NCT00355147|O1|Outcome|Arm 1 Stroke Self Management and Risk Factor Program|"Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support~Physician stroke guideline adherence: Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors~Secondary Stroke Self-Management and Risk Factor Management: Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/TIA"
1181900|NCT00355147|O2|Outcome|Attention Control Group|Received Phone Calls from Staff to Control for Attention
1181901|NCT00355147|O1|Outcome|Arm 1 Stroke Self Management and Risk Factor Program|"Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support~Physician stroke guideline adherence: Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors~Secondary Stroke Self-Management and Risk Factor Management: Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/TIA"
1181902|NCT00355147|E2|Reported Event|Attention Control Group|Received Phone Calls from Staff to Control for Attention
1181903|NCT00355147|E1|Reported Event|Arm 1 Stroke Self Management and Risk Factor Program|"Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support~Physician stroke guideline adherence: Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors~Secondary Stroke Self-Management and Risk Factor Management: Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/TIA"
1181904|NCT00355134|B6|Baseline|Total|Total of all reporting groups
1181905|NCT00355134|B5|Baseline|Extension: Fingolimod 0.5 mg|Participants who had received placebo in the Core phase and then received 0.5 mg fingolimod orally once a day in the Extension phase.
1181906|NCT00355134|B4|Baseline|Extension: Fingolimod 1.25 mg|Participants who had received placebo in the Core phase and then received 1.25 mg fingolimod orally once a day in the Extension phase. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
1181907|NCT00355134|B3|Baseline|Placebo (Core)|Participants received placebo capsules orally once a day for up to 24 months during the core phase. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
1181908|NCT00355134|B2|Baseline|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
1181909|NCT00355134|B1|Baseline|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
1181910|NCT00355134|P5|Participant Flow|Extension: Fingolimod 0.5 mg|Participants who had received placebo in the Core phase and then received 0.5 mg fingolimod orally once a day in the Extension phase.
1181911|NCT00355134|P4|Participant Flow|Extension: Fingolimod 1.25 mg|Participants who had received placebo in the Core phase and then received 1.25 mg fingolimod orally once a day in the Extension phase. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
1181912|NCT00355134|P3|Participant Flow|Placebo (Core)|Participants received placebo capsules orally once a day for up to 24 months during the core phase. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
1181913|NCT00355134|P2|Participant Flow|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
1181914|NCT00355134|P1|Participant Flow|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
1182079|NCT00354601|O1|Outcome|Docetaxel and Capecitabine|Docetaxel and Capecitabine therapy per protocol
1181915|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
1181916|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
1181917|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
1182058|NCT00354770|E2|Reported Event|Placebo|Placebo pills
1181918|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
1181919|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
1181920|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
1181921|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
1181922|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
1181923|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
1181924|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
1181925|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
1181926|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
1181927|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
1181928|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
1181929|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
1181930|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
1181931|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
1181932|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
1181933|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
1181934|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
1181936|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
1181937|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
1181938|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
1181939|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
1181940|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
1181941|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
1181942|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
1181943|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
1181944|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
1181945|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
1181946|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
1181947|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
1181948|NCT00355134|E5|Reported Event|Extension: Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day in the Extension phase.
1181949|NCT00355134|E4|Reported Event|Extension: Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day in the Extension phase. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
1181950|NCT00355134|E3|Reported Event|Core: Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
1181951|NCT00355134|E2|Reported Event|Core: Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase.
1181952|NCT00355134|E1|Reported Event|Core: Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
1181953|NCT00355121|B4|Baseline|Total|Total of all reporting groups
1181954|NCT00355121|B3|Baseline|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
1181955|NCT00355121|B2|Baseline|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
1181956|NCT00355121|B1|Baseline|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
1181957|NCT00355121|P3|Participant Flow|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
1182047|NCT00354887|B1|Baseline|Oxaliplatin + Capecitabine|Intravenous Oxaliplatin 130 mg/m^2, Day 1 + Oral Capecitabine 750 mg/m^2 twice daily Days 1-14.
1195556|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
1181958|NCT00355121|P2|Participant Flow|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
1181959|NCT00355121|P1|Participant Flow|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
1181960|NCT00355121|O3|Outcome|Group 3: DAPTACEL on Day 30 (Visit 2)|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
1181961|NCT00355121|O2|Outcome|Group 2: IPOL on Day 30 (Visit 2)|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
1181962|NCT00355121|O1|Outcome|Group 1: Menactra on Day 30 (Visit 2)|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
1181963|NCT00355121|O3|Outcome|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
1181964|NCT00355121|O2|Outcome|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
1181965|NCT00355121|O1|Outcome|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
1181966|NCT00355121|O3|Outcome|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
1181967|NCT00355121|O2|Outcome|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
1181968|NCT00355121|O1|Outcome|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
1181969|NCT00355121|O3|Outcome|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
1181970|NCT00355121|O2|Outcome|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
1181971|NCT00355121|O1|Outcome|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
1181972|NCT00355121|O3|Outcome|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
1181973|NCT00355121|O2|Outcome|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
1181974|NCT00355121|O1|Outcome|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
1181975|NCT00355121|O3|Outcome|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
1181976|NCT00355121|O2|Outcome|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
1181977|NCT00355121|O1|Outcome|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
1182080|NCT00354601|E1|Reported Event|Docetaxel and Capecitabine|Docetaxel and Capecitabine therapy per protocol
1181978|NCT00355121|O3|Outcome|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
1181979|NCT00355121|O2|Outcome|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
1181980|NCT00355121|O1|Outcome|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
1181981|NCT00355121|O3|Outcome|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
1181982|NCT00355121|O2|Outcome|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
1181983|NCT00355121|O1|Outcome|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
1181984|NCT00355121|E3|Reported Event|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
1181985|NCT00355121|E2|Reported Event|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
1181986|NCT00355121|E1|Reported Event|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
1181987|NCT00355082|B3|Baseline|Total|Total of all reporting groups
1181988|NCT00355082|B2|Baseline|Treatment Phase: LTG XR, 250 mg|LTG XR, 250 mg/day in the Treatment phase
1181989|NCT00355082|B1|Baseline|Treatment Phase: LTG XR, 300 mg|LTG XR, 300 mg/day in the Treatment phase
1181990|NCT00355082|P3|Participant Flow|Baseline Failures|Baseline failures that entered the Continuation Phase; LTG XR; 300 mg/day
1181991|NCT00355082|P2|Participant Flow|LTG XR, 250 mg|LTG XR, 250 mg/day
1181992|NCT00355082|P1|Participant Flow|Lamotrigine Extended-release (LTG XR), 300 mg|LTG XR, 300 mg/day. In the Continuation phase, Treatment phase participants received LTG XR, 300 mg/day.
1181993|NCT00355082|O2|Outcome|Baseline Failures|Baseline failures that entered the Continuation Phase; LTG XR; 300 mg/day
1181994|NCT00355082|O1|Outcome|Lamotrigine Extended-release (LTG XR), 300 mg|Treatment phase participants; LTG XR, 300 mg/day
1181995|NCT00355082|O2|Outcome|Baseline Failures|Baseline failures that entered the Continuation Phase; LTG XR; 300 mg/day
1181996|NCT00355082|O1|Outcome|Lamotrigine Extended-release (LTG XR), 300 mg|Treatment phase participants; LTG XR, 300 mg/day
1181997|NCT00355082|O2|Outcome|LTG XR, 250 mg|LTG XR, 250 mg/day
1181998|NCT00355082|O1|Outcome|Lamotrigine Extended-release (LTG XR), 300 mg|LTG XR, 300 mg/day
1181999|NCT00355082|O2|Outcome|LTG XR, 250 mg|LTG XR, 250 mg/day
1182000|NCT00355082|O1|Outcome|Lamotrigine Extended-release (LTG XR), 300 mg|LTG XR, 300 mg/day
1182001|NCT00355082|O2|Outcome|LTG XR, 250 mg|LTG XR, 250 mg/day
1182002|NCT00355082|O1|Outcome|Lamotrigine Extended-release (LTG XR), 300 mg|LTG XR, 300 mg/day
1182003|NCT00355082|O2|Outcome|LTG XR, 250 mg|LTG XR, 250 mg/day
1182004|NCT00355082|O1|Outcome|Lamotrigine Extended-release (LTG XR), 300 mg|LTG XR, 300 mg/day
1182005|NCT00355082|O1|Outcome|LTG XR, 250 mg|LTG XR, 250 mg/day
1182006|NCT00355082|O1|Outcome|Lamotrigine Extended-release (LTG XR), 300 mg|LTG XR, 300 mg/day
1182007|NCT00355082|E4|Reported Event|Continuation Phase: Baseline Failures|Baseline failures that entered the Continuation Phase; LTG XR; 300 mg/day
1182008|NCT00355082|E3|Reported Event|Continuation Phase: LTG XR, 300 mg|Treatment phase participants; LTG XR, 300 mg/day
1182009|NCT00355082|E2|Reported Event|Treatment Phase: LTG XR, 250 mg|LTG XR, 250 mg/day in the Treatment phase
1182010|NCT00355082|E1|Reported Event|Treatment Phase: LTG XR, 300 mg|LTG XR, 300 mg/day in the Treatment phase
1182011|NCT00355030|B3|Baseline|Total|Total of all reporting groups
1182012|NCT00355030|B2|Baseline|Somatropin|0.05mg/kg/day subcutaneous somatropin only
1182013|NCT00355030|B1|Baseline|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
1182014|NCT00355030|P2|Participant Flow|Somatropin: Experimental Arm 2|0.05mg/kg/day subcutaneous somatropin only
1182015|NCT00355030|P1|Participant Flow|Somatropin and Leuprorelin: Experimental Arm 1|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
1182016|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
1182048|NCT00354887|P1|Participant Flow|Oxaliplatin + Capecitabine|Intravenous Oxaliplatin 130 mg/m^2, Day 1 + Oral Capecitabine 750 mg/m^2 twice daily Days 1-14.
1182017|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
1182018|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
1182019|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
1182020|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
1182059|NCT00354770|E1|Reported Event|N-Acetyl Cysteine|N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day
1190878|NCT00325897|E1|Reported Event|Azithromycin|Azithromycin, 250 mg
1182021|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
1182022|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
1182023|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
1182024|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
1182025|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
1182026|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
1182027|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
1182028|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
1182029|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
1182030|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
1182031|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
1182032|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
1182033|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
1182034|NCT00355030|E2|Reported Event|Somatropin|Somatropin n=45
1182035|NCT00355030|E1|Reported Event|Somatropin and Leuprorelin|Somatropin and leuprorelin n=46
1182036|NCT00354978|B1|Baseline|FOLFIRI Plus Bevacizumab|FOLFIRI [folinic acid (leucovorin) 400 mg/m^2 by vein (IV) Day 1; 5-FU 400 mg/m^2 IV injection Day 1 immediately followed by 2.4 g/m^2 IV over 46 hours over Days 1-3; Irinotecan 180 mg/m^2 IV on Day 1] + Bevacizumab 5 mg/kg over 90 minutes on Day 1 administered alone then 5 mg/kg IV on Day 1 of 14 day cycle.
1182037|NCT00354978|P1|Participant Flow|FOLFIRI Plus Bevacizumab|FOLFIRI [folinic acid (leucovorin) 400 mg/m^2 by vein (IV) Day 1; 5-FU 400 mg/m^2 IV injection Day 1 immediately followed by 2.4 g/m^2 IV over 46 hours over Days 1-3; Irinotecan 180 mg/m^2 IV on Day 1] + Bevacizumab 5 mg/kg over 90 minutes on Day 1 administered alone then 5 mg/kg IV on Day 1 of 14 day cycle.
1182038|NCT00354978|O1|Outcome|FOLFIRI Plus Bevacizumab|FOLFIRI [folinic acid (leucovorin) 400 mg/m^2 by vein (IV) Day 1; 5-FU 400 mg/m^2 IV injection Day 1 immediately followed by 2.4 g/m^2 IV over 46 hours over Days 1-3; Irinotecan 180 mg/m^2 IV on Day 1] + Bevacizumab 5 mg/kg over 90 minutes on Day 1 administered alone then 5 mg/kg IV on Day 1 of 14 day cycle.
1182039|NCT00354978|E1|Reported Event|FOLFIRI Plus Bevacizumab|FOLFIRI [folinic acid (leucovorin) 400 mg/m^2 by vein (IV) Day 1; 5-FU 400 mg/m^2 IV injection Day 1 immediately followed by 2.4 g/m^2 IV over 46 hours over Days 1-3; Irinotecan 180 mg/m^2 IV on Day 1] + Bevacizumab 5 mg/kg over 90 minutes on Day 1 administered alone then 5 mg/kg IV on Day 1 of 14 day cycle.
1182040|NCT00354913|B1|Baseline|Imatinib Mesylate+Hydroxyurea|All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
1182041|NCT00354913|P1|Participant Flow|Imatinib Mesylate+Hydroxyurea|All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
1182042|NCT00354913|O1|Outcome|Imatinib Mesylate+Hydroxyurea|All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
1182043|NCT00354913|O1|Outcome|Imatinib Mesylate+Hydroxyurea|All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
1182044|NCT00354913|O1|Outcome|Imatinib Mesylate+Hydroxyurea|All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
1182045|NCT00354913|O1|Outcome|Imatinib Mesylate+Hydroxyurea|All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
1182046|NCT00354913|E1|Reported Event|Imatinib Mesylate+Hydroxyurea|All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
1182049|NCT00354887|O1|Outcome|Oxaliplatin + Capecitabine|Intravenous Oxaliplatin 130 mg/m^2, Day 1 + Oral Capecitabine 750 mg/m^2 twice daily Days 1-14.
1182050|NCT00354887|E1|Reported Event|Oxaliplatin + Capecitabine|Intravenous Oxaliplatin 130 mg/m^2, Day 1 + Oral Capecitabine 750 mg/m^2 twice daily Days 1-14.
1182051|NCT00354770|B3|Baseline|Total|Total of all reporting groups
1182052|NCT00354770|B2|Baseline|Placebo|Placebo pills
1182053|NCT00354770|B1|Baseline|N-Acetyl Cysteine|N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day
1182054|NCT00354770|P2|Participant Flow|Placebo|Placebo pills
1182055|NCT00354770|P1|Participant Flow|N-Acetyl Cysteine|N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day
1182056|NCT00354770|O2|Outcome|Placebo|Placebo pills
1182060|NCT00354744|B1|Baseline|High_Risk_Rhabdomyosarcoma|Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.
1182061|NCT00354744|P1|Participant Flow|High_Risk_Rhabdomyosarcoma|Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.
1182062|NCT00354744|O1|Outcome|High_Risk_Rhabdomyosarcoma|Patients with parameningeal (without intracranial extension) and paraspinal tumors should receive chemotherapy beginning Week 1 and begin radiation therapy at Week 20. Weeks 1-6 vincristine sulfate (VCR) & irinotecan hydrochloride (IRIN), Weeks 7-34 vincristine sulfate (VCR), Cyclophosphamide (CPM) with MESNA, Doxorubicin hydrochloride (DOX), Etoposide (ETOP), Ifosfamide (IFOS) with MESNA. Weeks 35-54 vincristine sulfate (VCR), Dactinomycin (DACT) and Cyclophosphamide (CPM) with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.
1182063|NCT00354744|O1|Outcome|High_Risk_Rhabdomyosarcoma|Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients
1182064|NCT00354744|E1|Reported Event|High_Risk_Rhabdomyosarcoma|Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.
1182065|NCT00354679|B1|Baseline|Irinotecan, Cisplatin, Bevacizumab, Radiotherapy, & Surger|Irinotecan, Cisplatin, Bevacizumab and Concurrent Radiotherapy in Locally Advanced Esophageal Adenocarcinoma
1182066|NCT00354679|P1|Participant Flow|Irinotecan, Cisplatin, Bevacizumab, Radiotherapy, & Surger|Irinotecan, Cisplatin, Bevacizumab and Concurrent Radiotherapy in Locally Advanced Esophageal Adenocarcinoma
1182067|NCT00354679|O1|Outcome|Irinotecan, Cisplatin, Bevacizumab, Radiotherapy, & Surger|Irinotecan, Cisplatin, Bevacizumab and Concurrent Radiotherapy in Locally Advanced Esophageal Adenocarcinoma
1182068|NCT00354679|E1|Reported Event|Irinotecan, Cisplatin, Bevacizumab, Radiotherapy, & Surger|Irinotecan, Cisplatin, Bevacizumab and Concurrent Radiotherapy in Locally Advanced Esophageal Adenocarcinoma
1182069|NCT00354640|B1|Baseline|Anastrozole and Simvastatin|"adjuvant therapy : laboratory analysis~pharmacological study : laboratory analysis~simvastatin : 40 milligram tablet PO QD for 14 days~anastrozole : 1 milligram tablet PO QD for 14 days"
1182070|NCT00354640|P1|Participant Flow|Anastrozole and Simvastatin|"adjuvant therapy : laboratory analysis~pharmacological study : laboratory analysis~simvastatin : 40 milligram tablet PO QD for 14 days~anastrozole : 1 milligram tablet PO QD for 14 days"
1182071|NCT00354640|O1|Outcome|Anastrozole and Simvastatin|"adjuvant therapy : laboratory analysis~pharmacological study : laboratory analysis~simvastatin : 40 milligram tablet PO QD for 14 days~anastrozole : 1 milligram tablet PO QD for 14 days"
1182072|NCT00354640|O1|Outcome|Anastrozole and Simvastatin|"adjuvant therapy : laboratory analysis~pharmacological study : laboratory analysis~simvastatin : 40 milligram tablet PO QD for 14 days~anastrozole : 1 milligram tablet PO QD for 14 days"
1182073|NCT00354640|E1|Reported Event|Anastrozole and Simvastatin|"adjuvant therapy : laboratory analysis~pharmacological study : laboratory analysis~simvastatin : 40 milligram tablet PO QD for 14 days~anastrozole : 1 milligram tablet PO QD for 14 days"
1182074|NCT00354601|B1|Baseline|Docetaxel and Capecitabine|Docetaxel and Capecitabine therapy per protocol
1182075|NCT00354601|P1|Participant Flow|Docetaxel and Capecitabine|Docetaxel and Capecitabine therapy per protocol
1182076|NCT00354601|O1|Outcome|Docetaxel and Capecitabine|Docetaxel and Capecitabine therapy per protocol
1182077|NCT00354601|O1|Outcome|Docetaxel and Capecitabine|Docetaxel and Capecitabine therapy per protocol
1182078|NCT00354601|O1|Outcome|Docetaxel and Capecitabine|Docetaxel and Capecitabine therapy per protocol
1182081|NCT00354484|B3|Baseline|Total|Total of all reporting groups
1182082|NCT00354484|B2|Baseline|Ferrous Sulfate Tablets|325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
1182083|NCT00354484|B1|Baseline|Ferric Carboxymaltose (FCM)|Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.
1182084|NCT00354484|P2|Participant Flow|Ferrous Sulfate Tablets|325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
1182085|NCT00354484|P1|Participant Flow|Ferric Carboxymaltose (FCM)|Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.
1182086|NCT00354484|O2|Outcome|Ferrous Sulfate Tablets|325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
1182087|NCT00354484|O1|Outcome|Ferric Carboxymaltose (FCM)|Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.
1182088|NCT00354484|E2|Reported Event|Ferrous Sulfate Tablets|325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
1182089|NCT00354484|E1|Reported Event|Ferric Carboxymaltose (FCM)|Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.
1182090|NCT00354432|B5|Baseline|Total|Total of all reporting groups
1182091|NCT00354432|B4|Baseline|Arm IV - Soy + Venlafaxine|Patients receive oral venlafaxine pill and oral soy protein/isoflavones powder once daily.
1182092|NCT00354432|B3|Baseline|Arm III - Venlafaxine|Patients receive oral venlafaxine pill and oral placebo powder once daily.
1182093|NCT00354432|B2|Baseline|Arm II - Soy|Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
1182094|NCT00354432|B1|Baseline|Arm I - Placebo|Patients receive oral placebo pill and oral placebo powder once daily.
1182095|NCT00354432|P4|Participant Flow|Arm IV - Soy + Venlafaxin|Patients receive oral venlafaxine pill and oral soy protein/isoflavones powder once daily.
1182096|NCT00354432|P3|Participant Flow|Arm III - Venlafaxine|Patients receive oral venlafaxine pill and oral placebo powder once daily.
1182097|NCT00354432|P2|Participant Flow|Arm II - Soy|Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
1182098|NCT00354432|P1|Participant Flow|Arm I - Placebo|Patients receive oral placebo pill and oral placebo powder once daily.
1182099|NCT00354432|O4|Outcome|Arm IV - Soy + Venlafaxine|Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.
1182100|NCT00354432|O3|Outcome|Arm III - Venlafaxine|Patients receive oral Venlafaxine pill and placebo powder once daily.
1182101|NCT00354432|O2|Outcome|Arm II - Soy|Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
1182102|NCT00354432|O1|Outcome|Arm I - Placebo|Patients receive oral placebo pill and oral placebo powder once daily.
1182103|NCT00354432|O4|Outcome|Arm IV - Soy + Venlafaxine|Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.
1182104|NCT00354432|O3|Outcome|Arm III - Venlafaxine|Patients receive oral Venlafaxine pill and placebo powder once daily.
1182105|NCT00354432|O2|Outcome|Arm II - Soy|Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
1182106|NCT00354432|O1|Outcome|Arm I - Placebo|Patients receive oral placebo pill and oral placebo powder once daily.
1182107|NCT00354432|E4|Reported Event|Arm IV - Soy + Venlafaxine|Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.
1182108|NCT00354432|E3|Reported Event|Arm III - Venlafaxine|Patients receive oral Venlafaxine pill and placebo powder once daily.
1182109|NCT00354432|E2|Reported Event|Arm II - Soy|Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.
1182110|NCT00354432|E1|Reported Event|Arm I - Placebo|Patients receive oral placebo pill and oral placebo powder once daily.
1182111|NCT00354341|B3|Baseline|Total|Total of all reporting groups
1182112|NCT00354341|B2|Baseline|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
1182113|NCT00354341|B1|Baseline|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
1182114|NCT00354341|P2|Participant Flow|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was less than (<) 10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
1182115|NCT00354341|P1|Participant Flow|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 International Units (IU) subcutaneously (SC) once weekly to reach and maintain target hemoglobin (Hb) between 13 and 15 grams per deciliter (g/dL), for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
1182116|NCT00354341|O2|Outcome|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
1182117|NCT00354341|O1|Outcome|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
1182244|NCT00353652|B4|Baseline|Irbesartan|"Drug: Irbesartan~150 mg taken orally, once daily"
1182118|NCT00354341|O2|Outcome|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
1182119|NCT00354341|O1|Outcome|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
1182143|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
1182188|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
1182120|NCT00354341|O2|Outcome|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
1182121|NCT00354341|O1|Outcome|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
1182122|NCT00354341|O2|Outcome|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
1182123|NCT00354341|O1|Outcome|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
1182124|NCT00354341|O2|Outcome|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
1182125|NCT00354341|O1|Outcome|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
1182126|NCT00354341|O2|Outcome|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
1182127|NCT00354341|O1|Outcome|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
1182128|NCT00354341|E2|Reported Event|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
1182129|NCT00354341|E1|Reported Event|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
1182130|NCT00354172|B1|Baseline|Patients Treated for Refractory Hematologic Cancers|All patients receiving at least partial study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
1182131|NCT00354172|P1|Participant Flow|Patients Treated for Refractory Hematologic Cancers|All patients receiving at least partial study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
1182132|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
1182133|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
1182134|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
1182135|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
1182136|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
1182137|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
1182138|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
1182320|NCT00353418|E2|Reported Event|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
1182139|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
1182140|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
1182141|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
1182142|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
1182144|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
1182145|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
1182146|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
1182147|NCT00354172|E1|Reported Event|Patients Treated for Refractory Hematologic Cancers|All patients receiving at least partial study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
1182148|NCT00354159|B3|Baseline|Total|Total of all reporting groups
1182149|NCT00354159|B2|Baseline|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
1182150|NCT00354159|B1|Baseline|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
1182151|NCT00354159|P2|Participant Flow|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
1182152|NCT00354159|P1|Participant Flow|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
1182153|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
1182154|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
1182155|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
1182156|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
1182157|NCT00354159|O1|Outcome|Chronicle ICD Implanted Subjects|Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system
1182158|NCT00354159|O1|Outcome|Chronicle ICD Implanted Subjects|Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system
1182159|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
1182160|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
1182161|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
1182162|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
1182163|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
1182164|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
1182165|NCT00354159|O2|Outcome|Heart Failure Event Control Subjects|Subjects randomized to the Control Arm that had a heart failure event during the 12-month randomized period
1182166|NCT00354159|O1|Outcome|Heart Failure Event Free Control Subjects|Subjects randomized to the Control Arm that did not have a heart failure related event during the 12-month randomized period
1182167|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
1182168|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
1182169|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
1182170|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
1182171|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
1182172|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
1182173|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
1182174|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
1182175|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
1182176|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
1182177|NCT00354159|O2|Outcome|Control Arm|Physicians do NOT have access to device-based hemodynamic monitor information to guide patient management
1182178|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
1182179|NCT00354159|O2|Outcome|Control Arm|Physicians do NOT have access to device-based hemodynamic monitor information to guide patient management
1182180|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
1182181|NCT00354159|O2|Outcome|Control Arm|Physicians do NOT have access to device-based hemodynamic monitor information to guide patient management
1182182|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
1182183|NCT00354159|O2|Outcome|Control Arm|Physicians do NOT have access to device-based hemodynamic monitor information to guide patient management
1182184|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
1182185|NCT00354159|O2|Outcome|Control Arm|Physicians do NOT have access to device-based hemodynamic monitor information to guide patient management
1182186|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
1182187|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
1182189|NCT00354159|O1|Outcome|Chronicle IHM Implanted Subjects|Analysis cohort includes the one subject with a Chronicle IHM implant attempt
1182190|NCT00354159|O1|Outcome|Chronicle ICD Implanted Subjects|Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system.
1182191|NCT00354159|E3|Reported Event|Enrolled, Not Randomized|42 subjects were enrolled but exited the study prior to randomization
1182192|NCT00354159|E2|Reported Event|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
1182193|NCT00354159|E1|Reported Event|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
1182194|NCT00354107|B1|Baseline|Treatment (Monoclonal Antibody Therapy, Chemotherapy)|"Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses** in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5).~Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study."
1182195|NCT00354107|P1|Participant Flow|Treatment (Monoclonal Antibody Therapy, Chemotherapy)|"Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses** in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5).~Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study."
1182196|NCT00354107|O1|Outcome|Treatment (Monoclonal Antibody Therapy, Chemotherapy)|"Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses** in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5).~Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study."
1182197|NCT00354107|E1|Reported Event|Treatment (Monoclonal Antibody Therapy, Chemotherapy)|"Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses** in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5).~Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study."
1182198|NCT00354029|B3|Baseline|Total|Total of all reporting groups
1182199|NCT00354029|B2|Baseline|Placebo|
1182200|NCT00354029|B1|Baseline|S (+) Ketamine|
1182201|NCT00354029|P2|Participant Flow|Placebo|
1182202|NCT00354029|P1|Participant Flow|S (+) Ketamine|
1182203|NCT00354029|O2|Outcome|Placebo|
1182204|NCT00354029|O1|Outcome|S (+) Ketamine|
1182205|NCT00354029|E2|Reported Event|Placebo|
1182206|NCT00354029|E1|Reported Event|S (+) Ketamine|
1182207|NCT00353977|B1|Baseline|Alvac pp65 Vaccine|Subjects received 2 or 3 doses of the vaccine
1182208|NCT00353977|P1|Participant Flow|Alvac pp65 Vaccine|Subjects received 2 or 3 doses of the vaccine
1182209|NCT00353977|O1|Outcome|Alvac pp65 Vaccine|Subjects received 2 or 3 doses of the vaccine
1182210|NCT00353977|E1|Reported Event|Alvac pp65 Vaccine|Subjects received 1, 2 or 3 doses of the vaccine
1182211|NCT00353873|B3|Baseline|Total|Total of all reporting groups
1182212|NCT00353873|B2|Baseline|SFC 50/100 mcg BD|Participants received one inhalation from dry powder inhaler A (SFC 50/100 mcg) and dry powder inhaler B (placebo for FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
1182213|NCT00353873|B1|Baseline|FP 200 mcg BD|Participants received one inhalation from dry powder inhaler A (FP 100 mcg) and dry powder inhaler B (FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
1182214|NCT00353873|P2|Participant Flow|Salmeterol/Fluticasone Propionate (SFC) 50/100 mcg BD|Participants received one inhalation from dry powder inhaler A (SFC 50/100 mcg) and dry powder inhaler B (placebo for FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
1182215|NCT00353873|P1|Participant Flow|FP 200 mcg BD|Participants received one inhalation from dry powder inhaler A (FP 100 mcg) and dry powder inhaler B (FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation metered dose inhaler (MDI) to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
1182216|NCT00353873|O2|Outcome|SFC 50/100 mcg BD|Participants received one inhalation from dry powder inhaler A (SFC 50/100 mcg) and dry powder inhaler B (placebo for FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
1182217|NCT00353873|O1|Outcome|FP 200 mcg BD|Participants received one inhalation from dry powder inhaler A (FP 100 mcg) and dry powder inhaler B (FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
1182218|NCT00353873|O2|Outcome|SFC 50/100 mcg BD|Participants received one inhalation from dry powder inhaler A (SFC 50/100 mcg) and dry powder inhaler B (placebo for FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
1182219|NCT00353873|O1|Outcome|FP 200 mcg BD|Participants received one inhalation from dry powder inhaler A (FP 100 mcg) and dry powder inhaler B (FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
1182220|NCT00353873|O2|Outcome|SFC 50/100 mcg BD|Participants received one inhalation from dry powder inhaler A (SFC 50/100 mcg) and dry powder inhaler B (placebo for FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
1182221|NCT00353873|O1|Outcome|FP 200 mcg BD|Participants received one inhalation from dry powder inhaler A (FP 100 mcg) and dry powder inhaler B (FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
1182222|NCT00353873|O2|Outcome|SFC 50/100 mcg BD|Participants received one inhalation from dry powder inhaler A (SFC 50/100 mcg) and dry powder inhaler B (placebo for FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
1182223|NCT00353873|O1|Outcome|FP 200 mcg BD|Participants received one inhalation from dry powder inhaler A (FP 100 mcg) and dry powder inhaler B (FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
1182224|NCT00353873|E2|Reported Event|SFC 50/100 mcg BD|Participants received one inhalation from dry powder inhaler A (SFC 50/100 mcg) and dry powder inhaler B (placebo for FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation MDI to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
1182225|NCT00353873|E1|Reported Event|FP 200 mcg BD|Participants received one inhalation from dry powder inhaler A (FP 100 mcg) and dry powder inhaler B (FP 100 mcg) BD, in the morning and evening for 12 weeks. Participants were provided salbutamol 100 mcg per actuation metered dose inhaler (MDI) to be used as needed throughout the study, for prevention of exercise induced asthma and symptomatic relief from asthma symptoms.
1182226|NCT00353795|B1|Baseline|Participants|Participants in the MESA trial (http://www.mesa-nhlbi.org/) randomly selected by the University of Washington Coordinating center who agreed to participate. Enrollment from October 2005 to February 2008
1182227|NCT00353795|P1|Participant Flow|Participants|Participants in the MESA trial (http://www.mesa-nhlbi.org/) randomly selected by the University of Washington Coordinating center who agreed to participate. Enrollment from October 2005 to February 2008
1182228|NCT00353795|O1|Outcome|Participants|Participants in the MESA trial (http://www.mesa-nhlbi.org/) randomly selected by the University of Washington Coordinating center who agreed to participate. Enrollment from October 2005 to February 2008
1182229|NCT00353795|E1|Reported Event|Participants|Participants in the MESA trial (http://www.mesa-nhlbi.org/) randomly selected by the University of Washington Coordinating center who agreed to participate. Enrollment from October 2005 to February 2008
1182230|NCT00353704|B3|Baseline|Total|Total of all reporting groups
1182231|NCT00353704|B2|Baseline|Placebo|
1182232|NCT00353704|B1|Baseline|Pregabalin|
1182233|NCT00353704|P2|Participant Flow|Placebo|
1182234|NCT00353704|P1|Participant Flow|Pregabalin|
1182235|NCT00353704|O2|Outcome|Placebo|
1182236|NCT00353704|O1|Outcome|Pregabalin|
1182237|NCT00353704|O2|Outcome|Placebo|
1182238|NCT00353704|O1|Outcome|Pregabalin|
1182239|NCT00353704|E2|Reported Event|Placebo|
1182240|NCT00353704|E1|Reported Event|Pregabalin|
1182241|NCT00353652|B7|Baseline|Total|Total of all reporting groups
1182242|NCT00353652|B6|Baseline|Spironolactone|Spironolactone: 25-75 mg taken orally, once daily
1182243|NCT00353652|B5|Baseline|Chlorthalidone|Chlorthalidone: 12.5-25 mg taken orally, once daily
1182245|NCT00353652|B3|Baseline|Chlorthalidone Plus Irbesartan|"Chlorthalidone: 12.5-25 mg taken orally, once daily~Irbesartan: 150 mg taken orally, once daily"
1182246|NCT00353652|B2|Baseline|Chlorthalidone Plus Spironolactone|"Chlorthalidone: 12.5-25 mg taken orally, once daily~Spironolactone: 50-75 mg taken orally, once daily"
1182247|NCT00353652|B1|Baseline|Chlorthalidone Alone|Chlorthalidone: 12.5-25 mg taken orally, once daily
1182248|NCT00353652|P6|Participant Flow|Spironolactone|Spironolactone 25-75 mg taken orally daily
1182249|NCT00353652|P5|Participant Flow|Chlorthalidone|Chlorthalidone 12.5-25 mg taken orally daily
1182250|NCT00353652|P4|Participant Flow|Irbesartan|"Drug: Irbesartan~150 mg taken orally, once daily"
1182251|NCT00353652|P3|Participant Flow|Chlorthalidone Plus Irbesartan|"Chlorthalidone: 12.5-25 mg taken orally, once daily~Irbesartan: 150 mg taken orally, once daily"
1182252|NCT00353652|P2|Participant Flow|Chlorthalidone Plus Spironolactone|"Chlorthalidone: 12.5-25 mg taken orally, once daily~Spironolactone: 50-75 mg taken orally, once daily"
1182253|NCT00353652|P1|Participant Flow|Chlorthalidone Alone|Chlorthalidone: 12.5-25 mg taken orally, once daily
1182254|NCT00353652|O6|Outcome|Irbesartan|Irbesartan 150 mg taken orally once a day
1182255|NCT00353652|O5|Outcome|Chlorthalidone|Chlorthalidone 12.5-25 mg taken orally
1182256|NCT00353652|O4|Outcome|Spironolactone|Spironolactone 25-50 mg taken orally daily
1182257|NCT00353652|O3|Outcome|Chlorthalidone Plus Irbesartan|"Chlorthalidone: 12.5-25 mg taken orally, once daily~Irbesartan: 150 mg taken orally, once daily"
1182258|NCT00353652|O2|Outcome|Chlorthalidone Plus Spironolactone|"Chlorthalidone: 12.5-25 mg taken orally, once daily~Spironolactone: 50-75 mg taken orally, once daily"
1182259|NCT00353652|O1|Outcome|Chlorthalidone Alone|Chlorthalidone: 12.5-25 mg taken orally, once daily
1182260|NCT00353652|E6|Reported Event|Spironolactone|Spironolactone 25-75 mg taken orally daily
1182261|NCT00353652|E5|Reported Event|Chlorthalidone|Chlorthalidone 12.5-25 mg taken orally daily
1182262|NCT00353652|E4|Reported Event|Irbesartan|Drug: Irbesartan 150 mg taken orally, once daily
1182263|NCT00353652|E3|Reported Event|Chlorthalidone Plus Irbesartan|"Chlorthalidone: 12.5-25 mg taken orally, once daily~Irbesartan: 150 mg taken orally, once daily"
1182264|NCT00353652|E2|Reported Event|Chlorthalidone Plus Spironolactone|"Chlorthalidone: 12.5-25 mg taken orally, once daily~Spironolactone: 50-75 mg taken orally, once daily"
1182265|NCT00353652|E1|Reported Event|Chlorthalidone Alone|Chlorthalidone: 12.5-25 mg taken orally, once daily
1182266|NCT00353496|B3|Baseline|Total|Total of all reporting groups
1182267|NCT00353496|B2|Baseline|Placebo|Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
1182268|NCT00353496|B1|Baseline|Lanreotide (Autogel Formulation)|120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
1182269|NCT00353496|P2|Participant Flow|Placebo|Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
1182270|NCT00353496|P1|Participant Flow|Lanreotide (Autogel Formulation)|120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
1182271|NCT00353496|O2|Outcome|Placebo|Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
1182272|NCT00353496|O1|Outcome|Lanreotide (Autogel Formulation)|lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
1182273|NCT00353496|O2|Outcome|Placebo|Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
1182274|NCT00353496|O1|Outcome|Lanreotide (Autogel Formulation)|lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
1182275|NCT00353496|O2|Outcome|Placebo|Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
1182276|NCT00353496|O1|Outcome|Lanreotide (Autogel Formulation)|lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
1182277|NCT00353496|O1|Outcome|Lanreotide (Autogel Formulation)|lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
1182278|NCT00353496|O2|Outcome|Placebo|Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
1182279|NCT00353496|O1|Outcome|Lanreotide (Autogel Formulation)|lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
1182280|NCT00353496|O2|Outcome|Placebo|Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
1182281|NCT00353496|O1|Outcome|Lanreotide (Autogel Formulation)|lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
1182282|NCT00353496|E2|Reported Event|Placebo|Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
1182283|NCT00353496|E1|Reported Event|Lanreotide (Autogel Formulation)|120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
1182284|NCT00353431|B3|Baseline|Total|Total of all reporting groups
1182285|NCT00353431|B2|Baseline|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
1182286|NCT00353431|B1|Baseline|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
1182321|NCT00353418|E1|Reported Event|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
1182322|NCT00353366|B1|Baseline|Rotarix Group|Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks
1182323|NCT00353366|P1|Participant Flow|Rotarix Group|Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks
1182287|NCT00353431|P2|Participant Flow|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
1182288|NCT00353431|P1|Participant Flow|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
1182289|NCT00353431|O2|Outcome|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
1182290|NCT00353431|O1|Outcome|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
1182291|NCT00353431|O2|Outcome|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
1182292|NCT00353431|O1|Outcome|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
1182293|NCT00353431|O2|Outcome|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
1182294|NCT00353431|O1|Outcome|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
1182295|NCT00353431|O2|Outcome|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
1182296|NCT00353431|O1|Outcome|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
1182297|NCT00353431|O2|Outcome|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
1182298|NCT00353431|O1|Outcome|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
1182299|NCT00353431|E2|Reported Event|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
1182300|NCT00353431|E1|Reported Event|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
1182301|NCT00353418|B3|Baseline|Total|Total of all reporting groups
1182302|NCT00353418|B2|Baseline|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
1182303|NCT00353418|B1|Baseline|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
1182304|NCT00353418|P2|Participant Flow|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
1182305|NCT00353418|P1|Participant Flow|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
1182306|NCT00353418|O2|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
1182307|NCT00353418|O1|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
1182308|NCT00353418|O2|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
1182309|NCT00353418|O1|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
1182310|NCT00353418|O2|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
1182311|NCT00353418|O1|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
1182312|NCT00353418|O2|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
1182313|NCT00353418|O1|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
1182314|NCT00353418|O2|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
1182315|NCT00353418|O1|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
1182316|NCT00353418|O2|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
1182317|NCT00353418|O1|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
1182318|NCT00353418|O2|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
1182319|NCT00353418|O1|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
1182324|NCT00353366|O1|Outcome|Rotarix Group|Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks
1182325|NCT00353366|O1|Outcome|Rotarix Group|Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks
1182326|NCT00353366|O1|Outcome|Rotarix Group|Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks
1182327|NCT00353366|O1|Outcome|Rotarix Group|Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks
1182328|NCT00353366|E1|Reported Event|Rotarix Group|Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks
1182329|NCT00353301|B1|Baseline|Erlotinib and Sirolimus|Erlotinib (Tarceva) therapy was started at 150 mg by mouth daily from day 1 to be taken at least 1 hour before or 2 hours after a meal. Sirolimus was initiated on day 8 (D8) with a loading dose of 6mg by mouth, followed by a daily dose of 2mg by mouth, on the basis of the product prescribing information for low-to-moderate immunologic risk renal transplant patients.
1182380|NCT00352911|E2|Reported Event|Placebo for VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
1182330|NCT00353301|P1|Participant Flow|Erlotinib and Sirolimus|Erlotinib (Tarceva) therapy was started at 150 mg by mouth daily from day 1 to be taken at least 1 hour before or 2 hours after a meal. Sirolimus was initiated on day 8 (D8) with a loading dose of 6mg by mouth, followed by a daily dose of 2mg by mouth, on the basis of the product prescribing information for low-to-moderate immunologic risk renal transplant patients.
1182331|NCT00353301|O1|Outcome|Erlotinib and Sirolimus|Erlotinib (Tarceva) therapy was started at 150 mg by mouth daily from day 1 to be taken at least 1 hour before or 2 hours after a meal. Sirolimus was initiated on day 8 (D8) with a loading dose of 6mg by mouth, followed by a daily dose of 2mg by mouth, on the basis of the product prescribing information for low-to-moderate immunologic risk renal transplant patients.
1182332|NCT00353301|O1|Outcome|Erlotinib and Sirolimus|Erlotinib (Tarceva) therapy was started at 150 mg by mouth daily from day 1 to be taken at least 1 hour before or 2 hours after a meal. Sirolimus was initiated on day 8 (D8) with a loading dose of 6mg by mouth, followed by a daily dose of 2mg by mouth, on the basis of the product prescribing information for low-to-moderate immunologic risk renal transplant patients.
1182333|NCT00353301|E1|Reported Event|Erlotinib and Sirolimus|Erlotinib (Tarceva) therapy was started at 150 mg by mouth daily from day 1 to be taken at least 1 hour before or 2 hours after a meal. Sirolimus was initiated on day 8 (D8) with a loading dose of 6mg by mouth, followed by a daily dose of 2mg by mouth, on the basis of the product prescribing information for low-to-moderate immunologic risk renal transplant patients.
1182334|NCT00353275|B3|Baseline|Total|Total of all reporting groups
1182335|NCT00353275|B2|Baseline|Conventional Glycemic Control|Blood glucose target range is 110-140 mg/dL.
1182336|NCT00353275|B1|Baseline|Strict Glycemic Control|Blood glucose target range is 80-110 mg/dL.
1182337|NCT00353275|P2|Participant Flow|Conventional Glycemic Control|Blood glucose target range is 110-140 mg/dL.
1182338|NCT00353275|P1|Participant Flow|Strict Glycemic Control|Blood glucose target range is 80-110 mg/dL.
1182339|NCT00353275|O2|Outcome|Conventional Glycemic Control|Blood glucose target range is 110-140 mg/dL.
1182340|NCT00353275|O1|Outcome|Strict Glycemic Control|Blood glucose target range is 80-110 mg/dL.
1182341|NCT00353275|E2|Reported Event|Conventional Glycemic Control|Blood glucose target range is 110-140 mg/dL.
1182342|NCT00353275|E1|Reported Event|Strict Glycemic Control|Blood glucose target range is 80-110 mg/dL.
1182343|NCT00353262|B1|Baseline|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
1182344|NCT00353262|P1|Participant Flow|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
1182345|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
1182370|NCT00353119|O1|Outcome|Placebo|Patients randomized to initiate the study with placebo for the first 12 weeks - Group 1
1182371|NCT00353119|E2|Reported Event|Etanercept|Patients randomized to etanercept who received etanercept 50 mg subcutaneously twice weekly for 24 weeks AND patients who crossed over to etanercept 50 mg subcutaneously twice a week for 12 weeks.
1182372|NCT00353119|E1|Reported Event|Placebo|Patients randomized to initiate the study with placebo for the first 12 weeks
1182373|NCT00352911|B3|Baseline|Total|Total of all reporting groups
1182374|NCT00352911|B2|Baseline|Placebo for VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
1182346|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
1182381|NCT00352911|E1|Reported Event|VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
1182347|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
1182348|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
1182349|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
1182350|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
1182351|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
1182352|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
1182353|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
1182354|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
1182355|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
1182356|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
1182357|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
1182358|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
1182359|NCT00353262|E1|Reported Event|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
1182360|NCT00353119|B3|Baseline|Total|Total of all reporting groups
1182361|NCT00353119|B2|Baseline|Etanercept|Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks
1182362|NCT00353119|B1|Baseline|Placebo Then Etanercept|Patients randomized to initiate the study with placebo for the first 12 weeks - Group 1 then crossed over to etanercept 50mg twice weekly for weeks 12 to 24
1182363|NCT00353119|P2|Participant Flow|Etanercept|Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks
1182364|NCT00353119|P1|Participant Flow|Placebo Then Etanercept|Patients randomized to initiate the study with placebo for the first 12 weeks - Group 1 then crossed over to etanercept 50mg twice weekly for weeks 12 to 24
1182365|NCT00353119|O1|Outcome|Etanercept After Placebo|Group 1 patients that crossed over to etanercept 50mg twice weekly for weeks 12 to 24 after having initiated the study with placebo for the first 12 weeks
1182366|NCT00353119|O1|Outcome|Etanercept|Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks
1182367|NCT00353119|O2|Outcome|Etanercept|Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks AND Patients that crossed over to etanercept 50 mg subcutanously twice weekly after taking placebo for the first 12 weeks.
1182368|NCT00353119|O1|Outcome|Placebo|Patients randomized to initiate the study with placebo for the first 12 weeks - Group 1
1182369|NCT00353119|O2|Outcome|Etanercept|Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks
1182375|NCT00352911|B1|Baseline|VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
1182376|NCT00352911|P2|Participant Flow|Placebo for VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
1182377|NCT00352911|P1|Participant Flow|VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
1182378|NCT00352911|O2|Outcome|Placebo for VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
1182379|NCT00352911|O1|Outcome|VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
1182383|NCT00352885|B2|Baseline|Placebo|Participants will receive placebo and IL-2 treatment
1182384|NCT00352885|B1|Baseline|Escitalopram|Participants will receive escitalopram and IL-2 treatment
1182385|NCT00352885|P2|Participant Flow|Placebo|Participants will receive placebo 2 weeks before and during IL-2 treatment
1182386|NCT00352885|P1|Participant Flow|Escitalopram|Participants will receive escitalopram 10-20 mg/day 2 weeks before and during IL-2 treatment
1182387|NCT00352885|O2|Outcome|Placebo|Participants will receive placebo and IL-2 treatment
1182388|NCT00352885|O1|Outcome|Escitalopram|Participants will receive escitalopram and IL-2 treatment
1182389|NCT00352885|E2|Reported Event|Placebo|Participants will receive placebo and IL-2 treatment
1182390|NCT00352885|E1|Reported Event|Escitalopram|Participants will receive escitalopram and IL-2 treatment
1182391|NCT00352846|B3|Baseline|Total|Total of all reporting groups
1182392|NCT00352846|B2|Baseline|Vitamin D + Calcium Carbonate + Zoledronic Acid|Oral Vitamin D 400 mg daily and Calcium 1200 mg daily; Zoledronic Acid 4 mg/m^2 intravenous at baseline and 6 months.
1182393|NCT00352846|B1|Baseline|Vitamin D + Calcium Carbonate|Oral Vitamin D 400 mg daily + Calcium 1200 mg daily
1182394|NCT00352846|P2|Participant Flow|Vitamin D + Calcium Carbonate + Zoledronic Acid|Oral Vitamin D 400 mg daily and Calcium 1200 mg daily; Zoledronic Acid 4 mg/m^2 intravenous at baseline and 6 months.
1182395|NCT00352846|P1|Participant Flow|Vitamin D + Calcium Carbonate|Oral Vitamin D 400 mg daily + Calcium 1200 mg daily
1182396|NCT00352846|O2|Outcome|Vitamin D + Calcium Carbonate + Zoledronic Acid|Oral Vitamin D 400 mg daily and Calcium 1200 mg daily; Zoledronic Acid 4 mg/m^2 intravenous at baseline and 6 months.
1182397|NCT00352846|O1|Outcome|Vitamin D + Calcium Carbonate|Oral Vitamin D 400 mg daily + Calcium 1200 mg daily
1182398|NCT00352846|E2|Reported Event|Vitamin D + Calcium Carbonate + Zoledronic Acid|Oral Vitamin D 400 mg daily and Calcium 1200 mg daily; Zoledronic Acid 4 mg/m^2 intravenous at baseline and 6 months.
1182399|NCT00352846|E1|Reported Event|Vitamin D + Calcium Carbonate|Oral Vitamin D 400 mg daily + Calcium 1200 mg daily
1182400|NCT00352781|B1|Baseline|Nicotine Replacement Therapy (NRT)|Open-label Nicotine Replacement Therapy + counseling
1182401|NCT00352781|P1|Participant Flow|Nicotine Replacement Therapy + Counseling|Up to 10 weeks of open-label nicotine replacement therapy (as per product monograph) + counseling
1182402|NCT00352781|O1|Outcome|Nicotine Replacement Therapy|Open-label nicotine replacement therapy (as per product monograph) plus counseling
1182403|NCT00352781|O1|Outcome|Nicotine Replacement Therapy|Open-label nicotine replacement therapy (as per product monograph) plus counseling
1182404|NCT00352781|E1|Reported Event|Nicotine Replacement Therapy + Counseling|Up to 10 weeks of open-label nicotine replacement therapy + counseling
1182405|NCT00352755|B1|Baseline|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy~IP 5FU 600 mg/m^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.~FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m^2 over 2 hours with leucovorin at 400 mg/m^2 and IV 5-FU at 2400 mg/m^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
1182406|NCT00352755|P1|Participant Flow|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy~IP 5FU 600 mg/m^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.~FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m^2 over 2 hours with leucovorin at 400 mg/m^2 and IV 5-FU at 2400 mg/m^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
1182407|NCT00352755|O1|Outcome|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy~IP 5FU 600 mg/m^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.~FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m^2 over 2 hours with leucovorin at 400 mg/m^2 and IV 5-FU at 2400 mg/m^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
1182408|NCT00352755|O1|Outcome|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy~IP 5FU 600 mg/m^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.~FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m^2 over 2 hours with leucovorin at 400 mg/m^2 and IV 5-FU at 2400 mg/m^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
1182409|NCT00352755|O1|Outcome|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy~IP 5FU 600 mg/m^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.~FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m^2 over 2 hours with leucovorin at 400 mg/m^2 and IV 5-FU at 2400 mg/m^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
1182410|NCT00352755|O1|Outcome|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy~IP 5FU 600 mg/m^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.~FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m^2 over 2 hours with leucovorin at 400 mg/m^2 and IV 5-FU at 2400 mg/m^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
1182450|NCT00352612|E2|Reported Event|Clindamycin|
1182451|NCT00352612|E1|Reported Event|Cephalexin|
1182452|NCT00352534|B3|Baseline|Total|Total of all reporting groups
1182411|NCT00352755|O1|Outcome|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy~IP 5FU 600 mg/m^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.~FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m^2 over 2 hours with leucovorin at 400 mg/m^2 and IV 5-FU at 2400 mg/m^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
1182412|NCT00352755|E1|Reported Event|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy~IP 5FU 600 mg/m2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.~FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m2 over 2 hours with leucovorin at 400 mg/m2 and IV 5-FU at 2400 mg/m2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
1182413|NCT00352690|B3|Baseline|Total|Total of all reporting groups
1182460|NCT00352534|P2|Participant Flow|Stage III|Patients who have either Standard Risk, Stage III and High Risk Patients prior to final Risk Group Assignment.
1182461|NCT00352534|P1|Participant Flow|Stage I/II|Patients who have either Very Low Risk Disease, Low Risk Stage I or II no LOH, and Standard Risk, Stage I or II with LOH prior to final Risk Group Assignment
1182414|NCT00352690|B2|Baseline|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
1182415|NCT00352690|B1|Baseline|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
1182416|NCT00352690|P2|Participant Flow|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
1182417|NCT00352690|P1|Participant Flow|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
1182418|NCT00352690|O2|Outcome|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
1182419|NCT00352690|O1|Outcome|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
1182420|NCT00352690|O2|Outcome|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
1182421|NCT00352690|O1|Outcome|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
1182422|NCT00352690|O2|Outcome|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
1182423|NCT00352690|O1|Outcome|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
1182453|NCT00352534|B2|Baseline|Stage III|Patients who have either Standard Risk, Stage III and High Risk Patients prior to final Risk Group Assignment.
1182454|NCT00352534|B1|Baseline|Stage I or II|Patients who have either Very Low Risk Disease, Low Risk Stage I or II no LOH, and Standard Risk, Stage I or II with LOH prior to final Risk Group Assignment.
1182455|NCT00352534|P7|Participant Flow|High Risk|Treatment arm. High risk.
1195557|NCT00313144|O1|Outcome|Year Prior to Baseline|
1182424|NCT00352690|O2|Outcome|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
1182462|NCT00352534|O1|Outcome|Very Low Risk|Very Low Risk
1182463|NCT00352534|O1|Outcome|Very Low Risk|Very Low Risk
1182464|NCT00352534|O3|Outcome|Standard Risk, Stage III|Standard Risk, Stage III
1182465|NCT00352534|O2|Outcome|Standard Risk, Stage I or II, With LOH|Standard Risk, Stage I or II, with LOH
1182425|NCT00352690|O1|Outcome|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
1182426|NCT00352690|O2|Outcome|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
1182427|NCT00352690|O1|Outcome|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
1182428|NCT00352690|O2|Outcome|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
1182429|NCT00352690|O1|Outcome|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
1182430|NCT00352690|O2|Outcome|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
1182431|NCT00352690|O1|Outcome|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
1182432|NCT00352690|E2|Reported Event|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
1182433|NCT00352690|E1|Reported Event|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
1182434|NCT00352664|B3|Baseline|Total|Total of all reporting groups
1182435|NCT00352664|B2|Baseline|Placebo|Oral Placebo tablet daily x 7 days
1182436|NCT00352664|B1|Baseline|Donepezil|Oral Donepezil 5 mg daily x 7 days
1182437|NCT00352664|P2|Participant Flow|Placebo|Oral Placebo tablet daily x 7 days
1182438|NCT00352664|P1|Participant Flow|Donepezil|Oral Donepezil 5 mg daily x 7 days
1182439|NCT00352664|O2|Outcome|Placebo|Oral Placebo tablet daily x 7 days
1182440|NCT00352664|O1|Outcome|Donepezil|Oral Donepezil 5 mg daily x 7 days
1182441|NCT00352664|E2|Reported Event|Placebo|Oral Placebo tablet daily x 7 days
1182442|NCT00352664|E1|Reported Event|Donepezil|Oral Donepezil 5 mg daily x 7 days
1182443|NCT00352612|B3|Baseline|Total|Total of all reporting groups
1182444|NCT00352612|B2|Baseline|Group 2|clindamycin arm
1182445|NCT00352612|B1|Baseline|Group 1|cephalexin arm
1182446|NCT00352612|P2|Participant Flow|Clindamycin|those who received clindamycin
1182447|NCT00352612|P1|Participant Flow|Cephalexin|patients who received cephalexin
1182448|NCT00352612|O2|Outcome|Clindamycin|those patients who received clindamycin
1182449|NCT00352612|O1|Outcome|Cephalexin|those patients who received cephalexin
1182456|NCT00352534|P6|Participant Flow|Standard Risk, Stage III|Treatment arm. Standard Risk, Stage III.
1182457|NCT00352534|P5|Participant Flow|Standard Risk, Stage I or II With LOH|Treatment arm. Standard Risk, Stage I or II with LOH.
1182458|NCT00352534|P4|Participant Flow|Low Risk, Stage I or II, no LOH|Treatment arm. Low risk, stage I or II, no loss of heterozygosity (LOH).
1182459|NCT00352534|P3|Participant Flow|Very Low Risk Disease|Treatment arm. Nephrectomy and re-evaluation,very low-risk disease.
1182467|NCT00352534|O3|Outcome|Standard Risk, Stage III|Standard Risk, Stage III
1182468|NCT00352534|O2|Outcome|Standard Risk, Stage I or II, With LOH|Standard Risk, Stage I or II, with LOH
1182469|NCT00352534|O1|Outcome|Very Low Risk|Very Low Risk
1182470|NCT00352534|E5|Reported Event|High Risk|High risk.
1182471|NCT00352534|E4|Reported Event|Standard Risk, Stage III|Nephrectomy/Biopsy, Chemotherapy
1182472|NCT00352534|E3|Reported Event|Standard Risk, Stage I or II, With LOH|Standard Risk, Stage I or II, with loss of heterozygosity (LOH).
1182473|NCT00352534|E2|Reported Event|Low Risk, Stage I or II, no LOH|Low risk, stage I or II, no loss of heterozygosity (LOH).
1182474|NCT00352534|E1|Reported Event|Very Low Risk Disease|Nephrectomy and Re-evaluation
1182475|NCT00352417|B3|Baseline|Total|Total of all reporting groups
1182476|NCT00352417|B2|Baseline|Matching Placebo|Placebo Dose
1182477|NCT00352417|B1|Baseline|VIA-2291|100-mg dose
1182478|NCT00352417|P2|Participant Flow|Matching Placebo|Placebo Dose
1182479|NCT00352417|P1|Participant Flow|VIA-2291|100-mg dose
1182480|NCT00352417|O2|Outcome|Matching Placebo|Placebo Dose
1182481|NCT00352417|O1|Outcome|VIA-2291|100-mg dose
1182482|NCT00352417|O2|Outcome|Matching Placebo|Placebo Dose
1182483|NCT00352417|O1|Outcome|VIA-2291|100-mg dose
1182484|NCT00352417|O2|Outcome|Matching Placebo|Placebo Dose
1182485|NCT00352417|O1|Outcome|VIA-2291|100-mg dose
1182486|NCT00352417|O2|Outcome|Matching Placebo|Placebo Dose
1182487|NCT00352417|O1|Outcome|VIA-2291|100-mg dose
1182488|NCT00352417|O2|Outcome|Matching Placebo|Placebo Dose
1182489|NCT00352417|O1|Outcome|VIA-2291|100-mg dose
1182490|NCT00352417|E2|Reported Event|Matching Placebo|Placebo Dose
1182491|NCT00352417|E1|Reported Event|VIA-2291|100-mg dose
1182492|NCT00352365|B1|Baseline|Induction Therapy|Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
1182493|NCT00352365|P1|Participant Flow|Lenalidomide|Induction Therapy: Oral lenalidomide once daily on days 1-14, 1-21, or 1-28. Maintenance Therapy: Oral lenalidomide once daily on days 1-21 (1 cycle = 28 days)
1182494|NCT00352365|O1|Outcome|Induction Therapy|Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
1182495|NCT00352365|O1|Outcome|Induction Therapy|Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
1182496|NCT00352365|O2|Outcome|Nonresponders|Eligible and evaluable patients who did not achieve CR/CRi/PR
1182497|NCT00352365|O1|Outcome|Responders|Eligible and evaluable patients who achieved CR/CRi/PR
1182498|NCT00352365|O2|Outcome|Maintenance Therapy|Oral lenalidomide once daily on days 1-21 (1 cycle = 28 days)
1182499|NCT00352365|O1|Outcome|Induction Therapy|Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
1182500|NCT00352365|E2|Reported Event|Maintenance Therapy|Oral lenalidomide once daily on days 1-21 (1 cycle = 28 days)
1182501|NCT00352365|E1|Reported Event|Induction Therapy|Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
1182502|NCT00352118|B1|Baseline|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
1182503|NCT00352118|P1|Participant Flow|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
1182504|NCT00352118|O1|Outcome|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
1182505|NCT00352118|O1|Outcome|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
1182506|NCT00352118|O1|Outcome|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
1182507|NCT00352118|O1|Outcome|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
1182508|NCT00352118|O1|Outcome|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
1182509|NCT00352118|O1|Outcome|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
1182510|NCT00352118|O1|Outcome|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
1182511|NCT00352118|E1|Reported Event|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
1182512|NCT00352105|B1|Baseline|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
1182513|NCT00352105|P1|Participant Flow|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
1182514|NCT00352105|O1|Outcome|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
1182515|NCT00352105|O1|Outcome|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
1182516|NCT00352105|O1|Outcome|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
1182517|NCT00352105|O1|Outcome|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
1182518|NCT00352105|O1|Outcome|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
1182519|NCT00352105|O1|Outcome|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
1182520|NCT00352105|E1|Reported Event|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
1182521|NCT00352053|B3|Baseline|Total|Total of all reporting groups
1182522|NCT00352053|B2|Baseline|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks.
1182523|NCT00352053|B1|Baseline|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks.
1182524|NCT00352053|P2|Participant Flow|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks.
1182525|NCT00352053|P1|Participant Flow|Tenofovir DF|Tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg tablets plus a genotype-guided optimized background regimen (OBR; 3 minimum (min.)/5 maximum (max.) antiretroviral agents (ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks.
1182526|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182527|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182528|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182529|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182530|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182531|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182532|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182533|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182534|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182535|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182536|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182537|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182538|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182539|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182540|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182541|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182542|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182543|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182544|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182545|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182546|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182547|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182548|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
1182549|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
1182550|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182551|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182552|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
1182553|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
1182554|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182555|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182702|NCT00352027|O2|Outcome|HOD05 - Grade 3|Participants in current study.
1182556|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182557|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182558|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182559|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1190879|NCT00325819|B3|Baseline|Total|Total of all reporting groups
1182560|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182561|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182562|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182563|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182564|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182565|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182566|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA >= 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182567|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182568|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182569|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182570|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182571|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182572|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182573|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182574|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
1182575|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
1182576|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182703|NCT00352027|O1|Outcome|HOD05 - Grade 2|Participants in current study.
1182725|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182577|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182578|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
1182579|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
1182727|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1191315|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
1182580|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182581|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182582|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182583|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182584|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182585|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182586|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182587|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182588|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182589|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182590|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182591|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182592|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182593|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182594|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182595|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182596|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182597|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182722|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
1195558|NCT00313144|O5|Outcome|>18 Months to ≤24 Months|
1182598|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182599|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182600|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
1182601|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
1182602|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182603|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182604|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
1182605|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
1182606|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182607|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182608|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182609|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182610|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182611|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182612|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182613|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182614|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182615|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182616|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182617|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182618|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182726|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
1182619|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182620|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182621|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182622|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182623|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182624|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182625|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182626|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
1182627|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
1182628|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182629|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182630|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
1182631|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
1182632|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182633|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182634|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182635|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182636|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182637|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182638|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182639|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182774|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
1182640|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182641|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182642|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182643|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182644|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182645|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182646|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182647|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182648|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182649|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182650|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182651|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182652|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
1182653|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
1182654|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182655|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182656|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
1182657|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
1182658|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182659|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182660|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182723|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
1182661|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182662|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182663|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182664|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182665|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182666|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182667|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182668|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182669|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182670|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182671|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182672|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182673|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182674|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182675|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
1182676|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182677|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182678|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
1182679|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
1182680|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182681|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
1182724|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
1182682|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
1182683|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
1182728|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182729|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
1182684|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
1182685|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
1182686|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
1182687|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
1182688|NCT00352053|E3|Reported Event|All TDF|"Adverse events reported for the All TDF group include those reported during the double-blind phase and/or extension phase for subjects who were randomized to TDF group plus adverse events reported during the extension phase only for subjects who switched from placebo to open-label TDF.~Tenofovir DF 300-mg tablets in participants initially randomized to the Tenofovir DF group, and in those initially randomized to the Placebo group who later switched to open-label TDF 300 mg."
1182689|NCT00352053|E2|Reported Event|Placebo|"Adverse events occurring in the double-blind phase are presented for this reporting group.~Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks."
1182690|NCT00352053|E1|Reported Event|Tenofovir DF|"Adverse events occurring in the double-blind phase are presented for this reporting group.~TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks."
1182691|NCT00352027|B1|Baseline|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
1182692|NCT00352027|P1|Participant Flow|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
1182693|NCT00352027|O1|Outcome|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
1182694|NCT00352027|O1|Outcome|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
1182695|NCT00352027|O1|Outcome|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
1182696|NCT00352027|O8|Outcome|HOD99 - Grade 5|Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
1182697|NCT00352027|O7|Outcome|HOD99 - Grade 4|Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
1182698|NCT00352027|O6|Outcome|HOD99 - Grade 3|Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
1182699|NCT00352027|O5|Outcome|HOD99 - Grade 2|Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
1182700|NCT00352027|O4|Outcome|HOD05 - Grade 5|Participants in current study.
1182701|NCT00352027|O3|Outcome|HOD05 - Grade 4|Participants in current study.
1182730|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182731|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
1182732|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182733|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1183410|NCT00350402|B2|Baseline|Sham MST|Low intensity muscle strength training (5% MIP)
1182704|NCT00352027|O2|Outcome|HOD99 Participants|"Intermediate Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital. Intermediate Risk was defined as participants with stage classified as:~EITHER Ann Arbor stage IB and IIIA, OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).~Participants received 2 alternating cycles of VAMP/COP chemotherapy (total of 4 cycles of chemotherapy) plus low-dose, involved-field radiotherapy. VAMP chemotherapy includes vinblastine, adriamycin, methotrexate and prednisone. COP chemotherapy includes Cyclophosphamide, Oncovin and Procarbazine."
1182705|NCT00352027|O1|Outcome|HOD05 Participants|"Current study defined as Intermediate Risk single arm classified as:~EITHER Ann Arbor stage IB and IIIA,~OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).~Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
1182706|NCT00352027|O2|Outcome|HOD99 Participants|"Intermediate Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital. Intermediate Risk was defined as participants with stage classified as:~EITHER Ann Arbor stage IB and IIIA, OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).~Participants received 2 alternating cycles of VAMP/COP chemotherapy (total of 4 cycles of chemotherapy) plus low-dose, involved-field radiotherapy. VAMP chemotherapy includes vinblastine, adriamycin, methotrexate and prednisone. COP chemotherapy includes Cyclophosphamide, Oncovin and Procarbazine."
1182707|NCT00352027|O1|Outcome|HOD05 Participants|"Current study defined as Intermediate Risk single arm classified as:~EITHER Ann Arbor stage IB and IIIA,~OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).~Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
1182708|NCT00352027|O2|Outcome|HOD99 Participants|"Intermediate Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital. Intermediate Risk was defined as participants with stage classified as:~EITHER Ann Arbor stage IB and IIIA,~OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).~Participants received 2 alternating cycles of VAMP/COP chemotherapy (total of 4 cycles of chemotherapy) plus low-dose, involved-field radiotherapy. VAMP chemotherapy includes vinblastine, adriamycin, methotrexate and prednisone. COP chemotherapy includes Cyclophosphamide, Oncovin and Procarbazine."
1182709|NCT00352027|O1|Outcome|HOD05 Participants|"Current study defined as Intermediate Risk single arm classified as:~EITHER Ann Arbor stage IB and IIIA,~OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).~Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
1182710|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
1182711|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
1182712|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
1182713|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
1182714|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
1182715|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
1182716|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
1182717|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
1182718|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
1182719|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
1182720|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
1182721|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
1182734|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
1182735|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182736|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
1182737|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182738|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182739|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
1182740|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182741|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
1182742|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182743|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182744|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
1182745|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182746|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
1182747|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182748|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182749|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
1182750|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182751|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
1182752|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182753|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182754|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
1182755|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182756|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
1182757|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182758|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182759|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
1182760|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182761|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
1182762|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182763|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182764|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
1182765|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182766|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
1182767|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182768|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182769|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
1182770|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182771|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
1182772|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182773|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182884|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
1182775|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182776|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
1182777|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182778|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182779|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
1182780|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182781|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
1182782|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182783|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182784|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
1182785|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182786|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
1182787|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182788|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182789|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
1182790|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182791|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
1182792|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182793|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182794|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
1182795|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182796|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
1182797|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182798|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182799|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
1182800|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182801|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
1182802|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182803|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182804|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
1182805|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182806|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
1182807|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182808|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182809|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
1182810|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182811|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
1182812|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182813|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182814|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
1182815|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182816|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
1182817|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182818|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182819|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
1182820|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182821|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
1182822|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182823|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182824|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
1182825|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182826|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
1182827|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182828|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182829|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
1182830|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182831|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
1182832|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182833|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182834|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
1183439|NCT00350220|B3|Baseline|Total|Total of all reporting groups
1182835|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182836|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
1182837|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182838|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182839|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
1182840|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182841|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
1182842|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182843|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182844|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
1182845|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182846|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
1182847|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182848|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182849|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
1182850|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182851|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
1182852|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182853|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182854|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
1182855|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182856|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
1182857|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182858|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182859|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
1182860|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182861|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
1182862|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182863|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182864|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
1182865|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182866|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
1182867|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182868|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182869|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
1182870|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182871|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
1182872|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182873|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182874|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
1182875|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182876|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
1182877|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182878|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182879|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
1182880|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182881|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
1182882|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182883|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182885|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182886|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
1182887|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182888|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182889|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
1182890|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182891|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
1182892|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182893|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182894|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
1182895|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182896|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
1182897|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182898|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182899|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
1182900|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182901|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
1182902|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182903|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182904|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
1182905|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182906|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
1182907|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182908|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182909|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
1182910|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182911|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
1182912|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182913|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182914|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
1182915|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182916|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
1182917|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182918|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182919|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
1182920|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182921|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
1182922|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182923|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182924|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
1182925|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182926|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
1182927|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182928|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182929|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
1182930|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182931|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
1182932|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182933|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182934|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
1182935|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182936|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
1182937|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182938|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182939|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
1182940|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182941|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
1195559|NCT00313144|O4|Outcome|>12 Months to ≤18 Months|
1182942|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182943|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182944|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
1182945|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182946|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
1182947|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182948|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182949|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
1182950|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
1182951|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
1182952|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
1182953|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
1182954|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
1182955|NCT00352027|O1|Outcome|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
1182956|NCT00352027|O1|Outcome|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
1182957|NCT00352027|O1|Outcome|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
1182958|NCT00352027|O1|Outcome|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
1182959|NCT00352027|E1|Reported Event|Stanford V Chemotherapy|"Intermediate risk single arm study defined as~EITHER Ann Arbor stage IB and IIIA,~OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).~Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
1182960|NCT00351936|B1|Baseline|Cross-over Aripiprazole and Placebo|This double-blind, placebo-controlled, crossover study consisted of 2 random-order 4-week treatment arms(aripiprazole 15 mg or placebo) separated by a 2-week adjuvant treatment washout. After baseline, subjects were randomized, double blind, to either aripiprazole or placebo for 4 weeks. After the initial 4 weeks of medication, subjects were reassessed, had a 2-week washout period, and then another complete assessment before receiving the other treatment of another 4 weeks. All assessments were again repeated at week 10.
1182961|NCT00351936|P1|Participant Flow|Cross-over Aripiprazole and Placebo|This double-blind, placebo-controlled, crossover study consisted of 2 random-order 4-week treatment arms(aripiprazole 15 mg or placebo) separated by a 2-week adjuvant treatment washout. After baseline, subjects were randomized, double blind, to either aripiprazole or placebo for 4 weeks. After the initial 4 weeks of medication, subjects were reassessed, had a 2-week washout period, and then another complete assessment before receiving the other treatment of another 4 weeks. All assessments were again repeated at week 10.
1182962|NCT00351936|O2|Outcome|Placebo|Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
1182963|NCT00351936|O1|Outcome|Aripiprazole|Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
1182964|NCT00351936|O2|Outcome|Placebo|Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
1182965|NCT00351936|O1|Outcome|Aripiprazole|Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
1182966|NCT00351936|O2|Outcome|Placebo|Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
1182967|NCT00351936|O1|Outcome|Aripiprazole|Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
1182968|NCT00351936|O2|Outcome|Placebo|Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
1183371|NCT00350636|E1|Reported Event|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
1182969|NCT00351936|O1|Outcome|Aripiprazole|Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
1182970|NCT00351936|O2|Outcome|Placebo|Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
1182971|NCT00351936|O1|Outcome|Aripiprazole|Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
1182972|NCT00351936|O2|Outcome|Placebo|Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
1182973|NCT00351936|O1|Outcome|Aripiprazole|Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
1182974|NCT00351936|O2|Outcome|Placebo|Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
1182975|NCT00351936|O1|Outcome|Aripiprazole|Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
1182976|NCT00351936|E1|Reported Event|Cross-over Aripiprazole and Placebo|This double-blind, placebo-controlled, crossover study consisted of 2 random-order 4-week treatment arms(aripiprazole 15 mg or placebo) separated by a 2-week adjuvant treatment washout. After baseline, subjects were randomized, double blind, to either aripiprazole or placebo for 4 weeks. After the initial 4 weeks of medication, subjects were reassessed, had a 2-week washout period, and then another complete assessment before receiving the other treatment of another 4 weeks. All assessments were again repeated at week 10.
1182977|NCT00351741|B3|Baseline|Total|Total of all reporting groups
1182978|NCT00351741|B2|Baseline|Conventional|Low-tidal volume ventilation
1182979|NCT00351741|B1|Baseline|High Frequency|Intervention with high frequency percussive ventilation
1182980|NCT00351741|P2|Participant Flow|Conventional|Low-tidal volume ventilation
1182981|NCT00351741|P1|Participant Flow|High Frequency|Intervention with high frequency percussive ventilation
1182982|NCT00351741|O2|Outcome|Conventional|Low-tidal volume ventilation
1182983|NCT00351741|O1|Outcome|High Frequency|Intervention with high frequency percussive ventilation
1182984|NCT00351741|O2|Outcome|Conventional|Low-tidal volume ventilation
1182985|NCT00351741|O1|Outcome|High Frequency|Intervention with high frequency percussive ventilation
1182986|NCT00351741|O2|Outcome|Conventional|Low-tidal volume ventilation
1182987|NCT00351741|O1|Outcome|High Frequency|Intervention with high frequency percussive ventilation
1182988|NCT00351741|O2|Outcome|Conventional|Low-tidal volume ventilation
1182989|NCT00351741|O1|Outcome|High Frequency|Intervention with high frequency percussive ventilation
1182990|NCT00351741|O2|Outcome|Conventional|Low-tidal volume ventilation
1182991|NCT00351741|O1|Outcome|High Frequency|Intervention with high frequency percussive ventilation
1182992|NCT00351741|O2|Outcome|Conventional|Low-tidal volume ventilation
1182993|NCT00351741|O1|Outcome|High Frequency|Intervention with high frequency percussive ventilation
1182994|NCT00351741|O2|Outcome|Conventional|Low-tidal volume ventilation
1182995|NCT00351741|O1|Outcome|High Frequency|Intervention with high frequency percussive ventilation
1182996|NCT00351741|E2|Reported Event|Conventional|Low-tidal volume ventilation
1182997|NCT00351741|E1|Reported Event|High Frequency|Intervention with high frequency percussive ventilation
1182998|NCT00351533|B3|Baseline|Total|Total of all reporting groups
1182999|NCT00351533|B2|Baseline|Enteral Saline|7.5cc 0.9% saline every 6 hours
1183000|NCT00351533|B1|Baseline|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
1183001|NCT00351533|P2|Participant Flow|Enteral Saline|7.5cc 0.9% saline every 6 hours
1183002|NCT00351533|P1|Participant Flow|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
1183003|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
1183004|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
1183005|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
1183006|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
1183007|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
1183008|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
1183009|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
1183010|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
1183011|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
1183012|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
1183013|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
1183014|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
1183015|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
1183016|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
1183017|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
1183018|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
1183019|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
1183020|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
1183021|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
1183022|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
1183023|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
1183024|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
1183025|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
1183026|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
1183027|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
1183028|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
1183029|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
1183030|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
1183031|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
1183032|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
1183033|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
1183034|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
1183035|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
1191321|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
1183036|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
1183037|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
1183038|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
1183039|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
1183040|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
1183041|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
1183042|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
1183043|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
1183044|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
1183045|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
1183046|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
1183047|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
1183048|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
1183049|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
1183050|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
1183051|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
1183052|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
1183053|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
1183054|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
1183055|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
1183056|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
1183057|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
1183058|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
1183059|NCT00351533|E2|Reported Event|Enteral Saline|7.5cc 0.9% saline every 6 hours
1183060|NCT00351533|E1|Reported Event|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
1183061|NCT00351468|B1|Baseline|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
1183062|NCT00351468|P1|Participant Flow|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
1183063|NCT00351468|O1|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
1183064|NCT00351468|O1|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
1183065|NCT00351468|O1|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
1183066|NCT00351468|O1|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
1183067|NCT00351468|O1|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
1183068|NCT00351468|O1|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
1183372|NCT00350623|B4|Baseline|Total|Total of all reporting groups
1183069|NCT00351468|O1|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
1183070|NCT00351468|O1|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
1183246|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
1183071|NCT00351468|O1|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
1183072|NCT00351468|O1|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
1183073|NCT00351468|O1|Outcome|Eltrombopag|Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.
1183074|NCT00351468|E2|Reported Event|Eltrombopag, >1 to 30 Days Post-Therapy|Eltrombopag, >1 to 30 Days Post-Therapy
1183075|NCT00351468|E1|Reported Event|Eltrombopag, Treatment + 1 Day|Eltrombopag, Treatment + 1 day
1183076|NCT00351416|B3|Baseline|Total|Total of all reporting groups
1183077|NCT00351416|B2|Baseline|Aromatase Inhibitor LFP|"Letrozole administration (20 mg daily x 2) at follicle size of > 16 mm (LFP; late follicular phase) in cycle 2.~Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.~Letrozole: Letrozole 20 mg orally one time~NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously"
1183078|NCT00351416|B1|Baseline|Aromatase Inhibitor EFP|"Letrozole administration (20 mg) on day 2-4 (EFP; early follicular phase) of cycle 2 and~Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.~Letrozole: Letrozole 20 mg orally one time~NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously"
1183079|NCT00351416|P2|Participant Flow|Aromatase Inhibitor LFP|"Letrozole administration (20 mg daily x 2) at follicle size of > 16 mm (LFP; late follicular phase) in cycle 2.~Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.~Letrozole: Letrozole 20 mg orally one time~NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously"
1183080|NCT00351416|P1|Participant Flow|Aromatase Inhibitor EFP|"Letrozole administration (20 mg) on day 2-4 (EFP; early follicular phase) of cycle 2 and~Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.~Letrozole: Letrozole 20 mg orally one time~NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously"
1183081|NCT00351416|O2|Outcome|Aromatase Inhibitor LFP|"Letrozole administration (20 mg daily x 2) at follicle size of > 16 mm (LFP; late follicular phase) in cycle 2.~Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.~Letrozole: Letrozole 20 mg orally one time~NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously"
1183082|NCT00351416|O1|Outcome|Aromatase Inhibitor EFP|"Letrozole administration (20 mg) on day 2-4 (EFP; early follicular phase) of cycle 2 and~Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.~Letrozole: Letrozole 20 mg orally one time~NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously"
1183083|NCT00351416|E2|Reported Event|Aromatase Inhibitor LFP|"Letrozole administration (20 mg daily x 2) at follicle size of > 16 mm (LFP; late follicular phase) in cycle 2.~Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.~Letrozole: Letrozole 20 mg orally one time~NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously"
1183084|NCT00351416|E1|Reported Event|Aromatase Inhibitor EFP|"Letrozole administration (20 mg) on day 2-4 (EFP; early follicular phase) of cycle 2 and~Nal-Glu GnRH antagonist used to estimate the overall amount of GnRH secreted.~Letrozole: Letrozole 20 mg orally one time~NAL-GLU GnRH antagonist: 5 mcg/kg of the NAL-GLU GnRH antagonist subcutaneously"
1183085|NCT00351377|B1|Baseline|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
1183086|NCT00351377|P1|Participant Flow|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
1183087|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
1183088|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
1183089|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
1183090|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
1183091|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
1183092|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
1183504|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183093|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
1183094|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
1183095|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
1183096|NCT00351377|E1|Reported Event|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
1183097|NCT00351351|B3|Baseline|Total|Total of all reporting groups
1183098|NCT00351351|B2|Baseline|Currently Available Lithotripsy Techology|"Currently available lithotripsy technology~single probe ultrasonic : FDA-approved - single probe ultrasonic"
1183099|NCT00351351|B1|Baseline|Cyberwand|"Cyberwand~Cyberwand : FDA approved - dual probe intracorporeal lithotrite"
1183100|NCT00351351|P2|Participant Flow|Currently Available Lithotripsy Technology|"Currently available lithotripsy technology~single probe ultrasonic : FDA-approved - single probe ultrasonic"
1183101|NCT00351351|P1|Participant Flow|Cyberwand|"Cyberwand~Cyberwand : FDA approved - dual probe intracorporeal lithotrite"
1183102|NCT00351351|O2|Outcome|Currently Available Lithotripsy Techology|"Currently available lithotripsy technology~single probe ultrasonic : FDA-approved - single probe ultrasonic"
1183103|NCT00351351|O1|Outcome|Cyberwand|"Cyberwand~Cyberwand : FDA approved - dual probe intracorporeal lithotrite"
1183104|NCT00351351|E2|Reported Event|Currently Available Lithotripsy Technology|"Currently available lithotripsy technology~single probe ultrasonic : FDA-approved - single probe ultrasonic"
1183105|NCT00351351|E1|Reported Event|Cyberwand|"Cyberwand~Cyberwand : FDA approved - dual probe intracorporeal lithotrite"
1183106|NCT00351299|B3|Baseline|Total|Total of all reporting groups
1183107|NCT00351299|B2|Baseline|Standard of Care|Standard of care per treating physician preference
1183108|NCT00351299|B1|Baseline|Infusion of Dexmedetomidine|"infusion 0.3-0.7 dexmedetomidine~Dexmedetomidine: dexmedetomidine infusion titrated to effect"
1183109|NCT00351299|P2|Participant Flow|Standard of Care|Standard of care per treating physician preference
1183110|NCT00351299|P1|Participant Flow|Infusion of Dexmedetomidine|"infusion 0.2-0.7 dexmedetomidine~Dexmedetomidine: dexmedetomidine infusion titrated to effect"
1183111|NCT00351299|O2|Outcome|Standard of Care|Standard of Care Per treating physician's preference
1183112|NCT00351299|O1|Outcome|Infusion of Dexmedetomidine|"infusion 0.3-0.7 dexmedetomidine~Dexmedetomidine: dexmedetomidine infusion titrated to effect"
1183113|NCT00351299|O2|Outcome|Standard of Care|Standard of care per attending physician's preference
1183114|NCT00351299|O1|Outcome|Infusion of Dexmedetomidine|"infusion 0.3-0.7 dexmedetomidine~Dexmedetomidine: dexmedetomidine infusion titrated to effect"
1183115|NCT00351299|O2|Outcome|Standard of Care|Standard of Care Per attending physician preference
1183116|NCT00351299|O1|Outcome|Infusion of Dexmedetomidine|"infusion 0.3-0.7 dexmedetomidine~Dexmedetomidine: dexmedetomidine infusion titrated to effect"
1183117|NCT00351299|O2|Outcome|Standard of Care|Standard of Care Per treating physician preference
1183118|NCT00351299|O1|Outcome|Infusion of Dexmedetomidine|"infusion 0.3-0.7 dexmedetomidine~Dexmedetomidine: dexmedetomidine infusion titrated to effect"
1183119|NCT00351299|O2|Outcome|Standard of Care|Standard of Care Per treating attending physician preference
1183120|NCT00351299|O1|Outcome|Infusion of Dexmedetomidine|"infusion 0.3-0.7 dexmedetomidine~Dexmedetomidine: dexmedetomidine infusion titrated to effect"
1183121|NCT00351299|E2|Reported Event|Standard of Care|Standard of care per treating physician preference
1183122|NCT00351299|E1|Reported Event|Infusion of Dexmedetomidine|"infusion 0.3-0.7 dexmedetomidine~Dexmedetomidine: dexmedetomidine infusion titrated to effect"
1183123|NCT00351273|B4|Baseline|Total|Total of all reporting groups
1183124|NCT00351273|B3|Baseline|Placebo|Participants will receive placebo
1183125|NCT00351273|B2|Baseline|Doxycycline & Rifampin|Participants will receive Doxycycline and Rifampin
1183126|NCT00351273|B1|Baseline|Azithromycin & Rifampin|Participants will receive Azithromycin and Rifampin
1183127|NCT00351273|P3|Participant Flow|Placebo|Participants will receive placebo
1183128|NCT00351273|P2|Participant Flow|Doxycycline & Rifampin|Participants will receive Doxycycline and Rifampin
1183129|NCT00351273|P1|Participant Flow|Azithromycin & Rifampin|Participants will receive Azithromycin and Rifampin
1183130|NCT00351273|O3|Outcome|Placebo|Participants will receive placebo
1183131|NCT00351273|O2|Outcome|Doxycycline & Rifampin|Participants will receive Doxycycline and Rifampin
1183132|NCT00351273|O1|Outcome|Azithromycin & Rifampin|Participants will receive Azithromycin and Rifampin
1183133|NCT00351273|E3|Reported Event|Placebo|Participants will receive placebo
1183134|NCT00351273|E2|Reported Event|Doxycycline & Rifampin|Participants will receive Doxycycline and Rifampin
1183135|NCT00351273|E1|Reported Event|Azithromycin & Rifampin|Participants will receive Azithromycin and Rifampin
1183136|NCT00351039|B1|Baseline|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:~Bevacizumab 15mg/kg Day 1 every 21 days (Q21); Pemetrexed 500 mg/m2 Day 1 Q 21; Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive). This dose was then recommended to be Phase II dose."
1183505|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183137|NCT00351039|P1|Participant Flow|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:~Bevacizumab 15mg/kg Day 1 every 21 days (Q21); Pemetrexed 500 mg/m2 Day 1 Q 21; Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive). This dose was then recommended to be Phase II dose."
1183138|NCT00351039|O1|Outcome|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg PO QD for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:~Bevacizumab 15mg/kg Day 1 Q21 Pemetrexed 500 mg/m2 Day 1 Q 21 Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive) This dose was then recommended to be phase II dose."
1183139|NCT00351039|O1|Outcome|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg PO QD for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:~Bevacizumab 15mg/kg Day 1 Q21 Pemetrexed 500 mg/m2 Day 1 Q 21 Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive) This dose was then recommended to be phase II dose."
1183140|NCT00351039|O1|Outcome|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:~Bevacizumab 15mg/kg Day 1 every 21 days (Q21); Pemetrexed 500 mg/m2 Day 1 Q 21; Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive). This dose was then recommended to be Phase II dose."
1183141|NCT00351039|O1|Outcome|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:~Bevacizumab 15mg/kg Day 1 every 21 days (Q21); Pemetrexed 500 mg/m2 Day 1 Q 21; Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive). This dose was then recommended to be Phase II dose."
1183142|NCT00351039|O1|Outcome|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:~Bevacizumab 15mg/kg Day 1 every 21 days (Q21); Pemetrexed 500 mg/m2 Day 1 Q 21; Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive). This dose was then recommended to be Phase II dose."
1183143|NCT00351039|O1|Outcome|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg PO QD for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:~Bevacizumab 15mg/kg Day 1 Q21 Pemetrexed 500 mg/m2 Day 1 Q 21 Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive) This dose was then recommended to be phase II dose."
1183144|NCT00351039|E1|Reported Event|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:~Bevacizumab 15mg/kg Day 1 every 21 days (Q21); Pemetrexed 500 mg/m2 Day 1 Q 21; Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive). This dose was then recommended to be Phase II dose."
1183145|NCT00351000|B1|Baseline|Open-label Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine or olanzapine dose will be unchanged during the trial.
1183146|NCT00351000|P1|Participant Flow|Open-label Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine or olanzapine dose will be unchanged during the trial.
1183147|NCT00351000|O2|Outcome|Olanzapine Treatment With Adjunctive Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine dose will be unchanged during the trial.
1183148|NCT00351000|O1|Outcome|Clozapine Treatment With Adjunctive Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine dose will be unchanged during the trial.
1183149|NCT00351000|O2|Outcome|Olanzapine Treatment With Adjunctive Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's olanzapine dosage will be unchanged during the trial.
1183150|NCT00351000|O1|Outcome|Clozapine Treatment With Adjunctive Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine dosage will be unchanged during the trial.
1183151|NCT00351000|E1|Reported Event|Open-label Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine or olanzapine dose will be unchanged during the trial.
1183152|NCT00350870|B5|Baseline|Total|Total of all reporting groups
1183153|NCT00350870|B4|Baseline|Disulfiram Plus Contingency Management|"Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Disulfiram plus Contingency Management: 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT."
1183154|NCT00350870|B3|Baseline|Placebo Plus Contingency Management|"Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Placebo plus Contingency Management: Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT"
1183155|NCT00350870|B2|Baseline|Disulfiram|"Disulfiram (plus CBT)~disulfiram: 250mg per day of Disulfiram plus CBT"
1183156|NCT00350870|B1|Baseline|Placebo|"Placebo (plus Cognitive Behavioral Therapy- CBT)~Placebo: Placebo plus CBT"
1183157|NCT00350870|P4|Participant Flow|Disulfiram Plus Contingency Management|"Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Disulfiram plus Contingency Management: 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT."
1183158|NCT00350870|P3|Participant Flow|Placebo Plus Contingency Management|"Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Placebo plus Contingency Management: Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT"
1183159|NCT00350870|P2|Participant Flow|Disulfiram|"Disulfiram (plus CBT)~disulfiram: 250mg per day of Disulfiram plus CBT"
1183160|NCT00350870|P1|Participant Flow|Placebo|"Placebo (plus Cognitive Behavioral Therapy- CBT)~Placebo: Placebo plus CBT"
1183161|NCT00350870|O4|Outcome|Disulfiram Plus Contingency Management|"Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Disulfiram plus Contingency Management: 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT."
1183162|NCT00350870|O3|Outcome|Placebo Plus Contingency Management|"Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Placebo plus Contingency Management: Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT"
1183163|NCT00350870|O2|Outcome|Disulfiram|"Disulfiram (plus CBT)~disulfiram: 250mg per day of Disulfiram plus CBT"
1183164|NCT00350870|O1|Outcome|Placebo|"Placebo (plus Cognitive Behavioral Therapy- CBT)~Placebo: Placebo plus CBT"
1183165|NCT00350870|O4|Outcome|Disulfiram Plus Contingency Management|"Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Disulfiram plus Contingency Management: 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT."
1183166|NCT00350870|O3|Outcome|Placebo Plus Contingency Management|"Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Placebo plus Contingency Management: Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT"
1183167|NCT00350870|O2|Outcome|Disulfiram|"Disulfiram (plus CBT)~disulfiram: 250mg per day of Disulfiram plus CBT"
1183168|NCT00350870|O1|Outcome|Placebo|"Placebo (plus Cognitive Behavioral Therapy- CBT)~Placebo: Placebo plus CBT"
1183169|NCT00350870|E4|Reported Event|Disulfiram Plus Contingency Management|"Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Disulfiram plus Contingency Management: 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT."
1183170|NCT00350870|E3|Reported Event|Placebo Plus Contingency Management|"Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Placebo plus Contingency Management: Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT"
1183171|NCT00350870|E2|Reported Event|Disulfiram|"Disulfiram (plus CBT)~disulfiram: 250mg per day of Disulfiram plus CBT"
1183172|NCT00350870|E1|Reported Event|Placebo|"Placebo (plus Cognitive Behavioral Therapy- CBT)~Placebo: Placebo plus CBT"
1183173|NCT00350844|B1|Baseline|Hydroxyurea|Hydroxyurea : 20 mg/kg/day and dose escalating every 2 months until maximum tolerated dose.
1183174|NCT00350844|P1|Participant Flow|Hydroxyurea|Hydroxyurea : 20 mg/kg/day and dose escalating every 2 months until maximum tolerated dose.
1183175|NCT00350844|O1|Outcome|Hydroxyurea|Hydroxyurea : 20 mg/kg/day and dose escalating every 2 months until maximum tolerated dose.
1183176|NCT00350844|E1|Reported Event|Hydroxyurea|Hydroxyurea : 20 mg/kg/day and dose escalating every 2 months until maximum tolerated dose.
1183177|NCT00350792|B1|Baseline|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.~Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
1183178|NCT00350792|P1|Participant Flow|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.~Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
1183179|NCT00350792|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.~Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
1183180|NCT00350792|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.~Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
1183181|NCT00350792|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.~Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
1183182|NCT00350792|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.~Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
1183183|NCT00350792|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.~Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
1183184|NCT00350792|E1|Reported Event|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.~Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
1183185|NCT00350779|B3|Baseline|Total|Total of all reporting groups
1183247|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
1183186|NCT00350779|B2|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
1183187|NCT00350779|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
1183188|NCT00350779|P2|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
1183189|NCT00350779|P1|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
1183190|NCT00350779|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
1183191|NCT00350779|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
1183192|NCT00350779|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
1183193|NCT00350779|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
1183194|NCT00350779|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
1183195|NCT00350779|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
1183196|NCT00350779|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
1183197|NCT00350779|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
1183198|NCT00350779|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
1183199|NCT00350779|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
1183200|NCT00350779|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
1183201|NCT00350779|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
1183202|NCT00350779|E4|Reported Event|Placebo Data Through Week 54|
1183203|NCT00350779|E3|Reported Event|Sitagliptin 100 mg Data Through Week 54|
1183204|NCT00350779|E2|Reported Event|Placebo Data Through Week 18|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
1183205|NCT00350779|E1|Reported Event|Sitagliptin 100 mg Data Through Week 18|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
1183206|NCT00350727|B4|Baseline|Total|Total of all reporting groups
1183207|NCT00350727|B3|Baseline|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
1183208|NCT00350727|B2|Baseline|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
1183248|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
1183249|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
1183209|NCT00350727|B1|Baseline|Phase I: Pazopanib 200-800 mg/Lapatinib 500-1500 mg|Starting dose of oral pazopanib of 200 milligrams (mg) once daily (OD) and oral lapatinib 1500 mg OD. The dose of pazopanib (200-800 mg) and lapatinib (500-1500 mg) in cohorts enrolled subsequent to the first dose cohort was determined by the toxicity profile of the combination therapy and the pharmacokinetic results from the prior cohort.
1183210|NCT00350727|P3|Participant Flow|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
1183211|NCT00350727|P2|Participant Flow|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
1183212|NCT00350727|P1|Participant Flow|Phase I: Pazopanib 200-800 mg/Lapatinib 500-1500 mg|Starting dose of oral pazopanib of 200 milligrams (mg) once daily (OD) and oral lapatinib 1500 mg OD. The dose of pazopanib (200-800 mg) and lapatinib (500-1500 mg) in cohorts enrolled subsequent to the first dose cohort was determined by the toxicity profile of the combination therapy and the pharmacokinetic results from the prior cohort.
1183213|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
1183214|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
1183215|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
1183216|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed EGFRvIII and/or PTEN.
1183217|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
1183218|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
1183219|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
1183220|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
1183221|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
1183222|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
1183223|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
1183224|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed EGFRvIII and/or PTEN.
1183225|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
1183226|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
1183227|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
1183228|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
1183229|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
1183230|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
1183231|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
1183232|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
1183233|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
1183234|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
1183235|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
1183236|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
1183237|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
1183238|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
1183239|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
1183240|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
1183241|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
1183242|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
1183243|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
1195560|NCT00313144|O3|Outcome|>6 Months to ≤12 Months|
1183244|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
1183245|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
1183250|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
1183251|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
1183252|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
1183253|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
1183254|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
1183255|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
1183256|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
1183257|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
1183258|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
1183259|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
1183260|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
1183261|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
1183262|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
1183263|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
1183264|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
1183265|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
1183266|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
1183267|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
1183268|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
1183269|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
1183270|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
1183271|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
1183272|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
1183273|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
1183274|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
1183275|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
1183276|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
1183277|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg /Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
1183278|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg /Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
1183279|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
1183280|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
1183281|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
1183282|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
1183283|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
1183284|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
1183285|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
1183286|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
1183287|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
1183288|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
1183289|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
1183290|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
1183291|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
1183292|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
1183293|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
1183294|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
1183295|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
1183296|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
1183297|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
1183298|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
1183299|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
1183300|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
1183301|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
1183302|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
1183303|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
1183304|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
1183305|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
1183306|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
1183307|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
1183308|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
1183309|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
1183310|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
1183311|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
1183312|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
1183313|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg /Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
1183314|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg /Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
1183315|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
1183316|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
1183317|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
1183318|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
1183319|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
1183320|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
1183321|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
1183322|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
1183323|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
1183324|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
1183325|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
1183326|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
1183327|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
1183328|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
1183329|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
1183330|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
1183331|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
1183332|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
1183333|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
1183373|NCT00350623|B3|Baseline|MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
1183334|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
1183335|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
1183336|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
1183337|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
1183338|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
1183339|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
1183340|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
1183341|NCT00350727|O3|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
1183342|NCT00350727|O2|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
1183343|NCT00350727|O1|Outcome|Phase I: Pazopanib 200-800 mg/Lapatinib 500-1500 mg|Starting dose of oral pazopanib of 200 milligrams (mg) once daily (OD) and oral lapatinib 1500 mg OD. The dose of pazopanib (200-800 mg) and lapatinib (500-1500 mg) in cohorts enrolled subsequent to the first dose cohort was determined by the toxicity profile of the combination therapy and the pharmacokinetic results from the prior cohort.
1183344|NCT00350727|O3|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
1183345|NCT00350727|O2|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
1183346|NCT00350727|O1|Outcome|Phase I: Pazopanib 200-800 mg/Lapatinib 500-1500 mg|Starting dose of oral pazopanib of 200 milligrams (mg) once daily (OD) and oral lapatinib 1500 mg OD. The dose of pazopanib (200-800 mg) and lapatinib (500-1500 mg) in cohorts enrolled subsequent to the first dose cohort was determined by the toxicity profile of the combination therapy and the pharmacokinetic results from the prior cohort.
1183347|NCT00350727|O3|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
1183348|NCT00350727|O2|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
1183349|NCT00350727|O1|Outcome|Phase I: Pazopanib 200-800 mg/Lapatinib 500-1500 mg|Starting dose of oral pazopanib of 200 milligrams (mg) once daily (OD) and oral lapatinib 1500 mg OD. The dose of pazopanib (200-800 mg) and lapatinib (500-1500 mg) in cohorts enrolled subsequent to the first dose cohort was determined by the toxicity profile of the combination therapy and the pharmacokinetic results from the prior cohort.
1183350|NCT00350727|E3|Reported Event|Phase II: Biomarker Negative|All participants received pazopanib 400 mg QD and lapatinib 1000 mg QD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
1183351|NCT00350727|E2|Reported Event|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (QD) and lapatinib 1000 mg QD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
1183352|NCT00350727|E1|Reported Event|Phase I: Pazopanib 200-800 mg/Lapatinib 500-1500 mg|Starting dose of oral pazopanib of 200 milligrams (mg) once daily (OD) and oral lapatinib 1500 mg OD. The dose of pazopanib (200-800 mg) and lapatinib (500-1500 mg) in cohorts enrolled subsequent to the first dose cohort was determined by the toxicity profile of the combination therapy and the pharmacokinetic results from the prior cohort.
1183353|NCT00350636|B3|Baseline|Total|Total of all reporting groups
1183354|NCT00350636|B2|Baseline|Placebo Topical Gel|1 g placebo topical gel
1183355|NCT00350636|B1|Baseline|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
1183356|NCT00350636|P2|Participant Flow|Placebo Topical Gel|1 g placebo topical gel
1183357|NCT00350636|P1|Participant Flow|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
1183358|NCT00350636|O2|Outcome|Placebo Topical Gel|1 g placebo topical gel
1183359|NCT00350636|O1|Outcome|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
1183360|NCT00350636|O2|Outcome|Placebo Topical Gel|1 g placebo topical gel
1183361|NCT00350636|O1|Outcome|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
1183362|NCT00350636|O2|Outcome|Placebo Topical Gel|1 g placebo topical gel
1183363|NCT00350636|O1|Outcome|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
1183364|NCT00350636|O2|Outcome|Placebo Topical Gel|1 g placebo topical gel
1183365|NCT00350636|O1|Outcome|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
1183366|NCT00350636|O2|Outcome|Placebo Topical Gel|1 g placebo topical gel
1183367|NCT00350636|O1|Outcome|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
1183368|NCT00350636|O2|Outcome|Placebo Topical Gel|1 g placebo topical gel
1183369|NCT00350636|O1|Outcome|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
1183370|NCT00350636|E2|Reported Event|Placebo Topical Gel|1 g placebo topical gel
1183374|NCT00350623|B2|Baseline|MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
1183375|NCT00350623|B1|Baseline|MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
1183376|NCT00350623|P3|Participant Flow|MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
1183377|NCT00350623|P2|Participant Flow|MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
1183378|NCT00350623|P1|Participant Flow|MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
1183379|NCT00350623|O3|Outcome|MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
1183380|NCT00350623|O2|Outcome|MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
1183381|NCT00350623|O1|Outcome|MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
1183382|NCT00350623|E3|Reported Event|MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
1183383|NCT00350623|E2|Reported Event|MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
1183384|NCT00350623|E1|Reported Event|MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
1183385|NCT00350532|B3|Baseline|Total|Total of all reporting groups
1183386|NCT00350532|B2|Baseline|Healthy Subjects|Healthy subjects with no existing pain conditions. Outcome criterion is acetylcholine concentration in cerebrospinal fluid (CSF) at 60 minutes after injection.
1183387|NCT00350532|B1|Baseline|Neuropathic Pain Subjects|Subjects with existing neuropathic pain Outcome criterion is acetylcholine concentration in cerebrospinal fluid (CSF) at 60 minutes after injection.
1183388|NCT00350532|P2|Participant Flow|Healthy Subjects|Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
1183389|NCT00350532|P1|Participant Flow|Neuropathic Pain Subjects|Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
1183390|NCT00350532|O2|Outcome|Healthy Subjects|Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
1183391|NCT00350532|O1|Outcome|Neuropathic Pain Subjects|Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
1183392|NCT00350532|E2|Reported Event|Healthy Subjects|Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
1183393|NCT00350532|E1|Reported Event|Neuropathic Pain Subjects|Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
1183394|NCT00350519|B3|Baseline|Total|Total of all reporting groups
1183395|NCT00350519|B2|Baseline|STANDARD THERAPY|Participants received standard of care based on the Institution’s treatment policy
1183396|NCT00350519|B1|Baseline|PROCRIT (Epoetin Alfa)|Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
1183397|NCT00350519|P2|Participant Flow|STANDARD THERAPY|Participants received standard of care based on the Institution’s treatment policy
1183398|NCT00350519|P1|Participant Flow|PROCRIT (Epoetin Alfa)|Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
1183399|NCT00350519|O2|Outcome|STANDARD THERAPY|Participants received standard of care based on the Institution’s treatment policy
1183400|NCT00350519|O1|Outcome|PROCRIT (Epoetin Alfa)|Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
1183401|NCT00350519|O2|Outcome|STANDARD THERAPY|Participants received standard of care based on the Institution’s treatment policy
1183402|NCT00350519|O1|Outcome|PROCRIT (Epoetin Alfa)|Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
1183403|NCT00350519|O2|Outcome|STANDARD THERAPY|Participants received standard of care based on the Institution’s treatment policy
1183404|NCT00350519|O1|Outcome|PROCRIT (Epoetin Alfa)|Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
1183405|NCT00350519|O2|Outcome|STANDARD THERAPY|Participants received standard of care based on the Institution’s treatment policy
1183406|NCT00350519|O1|Outcome|PROCRIT (Epoetin Alfa)|Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
1183407|NCT00350519|E2|Reported Event|STANDARD THERAPY|Participants received standard of care based on the Institution’s treatment policy
1183408|NCT00350519|E1|Reported Event|PROCRIT (Epoetin Alfa)|Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
1183411|NCT00350402|B1|Baseline|Inspiratory Muscle Strength Training (IMST)|high intensity respiratory muscle strength training, 75% MIP
1183412|NCT00350402|P2|Participant Flow|Sham MST|Low intensity muscle strength training (5% MIP)
1183413|NCT00350402|P1|Participant Flow|Inspiratory Muscle Strength Training (IMST)|high intensity respiratory muscle strength training, 75% MIP
1183414|NCT00350402|O2|Outcome|Sham IMST: 5% MIP|"This intervention is identical in all ways to real treatment, except that training device requires less inspiratory effort. The training device is set at 5% MIP. )"
1183415|NCT00350402|O1|Outcome|Inspiratory Muscle Strength Training (IMST): 75% MIP|Same as previously described. This intervention involves high intensity respiratory muscle strength training over 4 week period, 5 days a week, with training device set at 75% maximal inspiratory pressure (MIP). The MIP is determined weekly and the training device recalibrated to take into account changes.
1183416|NCT00350402|O2|Outcome|Sham IMST: 5% MIP|Low intensity muscle strength training (5% MIP)
1183417|NCT00350402|O1|Outcome|Inspiratory Muscle Strength Training (IMST): 75% MIP|high intensity respiratory muscle strength training, 75% MIP
1183418|NCT00350402|O2|Outcome|Sham IMST: 5% MIP|"Same as previously described. The Sham IMST intervention was identical to the real intervention in all ways except that the MIP is set for 5% MIP. Thus, less muscle effort was required during the exercise training."
1183419|NCT00350402|O1|Outcome|Inspiratory Muscle Strength Training (IMST): 75% MIP|"Same as previously described. High intensity respiratory muscle strength training took place over 4 weeks, 5 days a week. Each exercise session involved sets of breathing exercises taking approximately 20 minutes/day. The inspiratory exercises involved a breathing device that required individuals to take deep breaths and breathe in (i.e., inspire). Settings on breathing device were determined by obtaining the individual's maximal inspiratory pressure (MIP) using a specialized breathing gauge. The MIP was determined each week, and the exercise breathing trainer was adjusted and set at 75% of the participant's MIP. Exercises took place in the home setting, with weekly visit by staff."
1183420|NCT00350402|O2|Outcome|Sham IMST: 5% MIP|"The Sham IMST intervention was identical to the real intervention in all ways except that the MIP is set for 5% MIP. Thus, less muscle effort was required during the exercise training."
1183421|NCT00350402|O1|Outcome|Inspiratory Muscle Strength Training (IMST): 75% MIP|"High intensity respiratory muscle strength training took place over 4 weeks, 5 days a week. Each exercise session involved sets of breathing exercises taking approximately 20 minutes/day. The inspiratory exercises involved a breathing device that required individuals to take deep breaths and breathe in (i.e., inspire). Settings on breathing device were determined by obtaining the individual's maximal inspiratory pressure (MIP) using a specialized breathing gauge. The MIP was determined each week, and the exercise breathing trainer was adjusted and set at 75% of the participant's MIP. Exercises took place in the home setting, with weekly visit by staff."
1183422|NCT00350402|E2|Reported Event|Sham MST|Low intensity muscle strength training (5% MIP)
1183423|NCT00350402|E1|Reported Event|Inspiratory Muscle Strength Training (IMST)|high intensity respiratory muscle strength training, 75% MIP
1183424|NCT00350363|B1|Baseline|1 Day of Gatifloxacin|eyes receiving gatifloxacin 4 times per day 1 day before surgery
1183425|NCT00350363|P1|Participant Flow|1 Day of Gatifloxacin|eyes receiving gatifloxacin 4 times per day 1 day before surgery
1183426|NCT00350363|O1|Outcome|1 Day of Gatifloxacin|eyes receiving gatifloxacin 4 times per day 1 day before surgery
1183427|NCT00350363|E1|Reported Event|1 Day of Gatifloxacin|eyes receiving gatifloxacin 4 times per day 1 day before surgery
1183428|NCT00350272|B3|Baseline|Total|Total of all reporting groups
1183429|NCT00350272|B2|Baseline|Elvucitabine|Elvucitabine (blinded) 10 mg/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
1183430|NCT00350272|B1|Baseline|Lamivudine|Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
1183431|NCT00350272|P2|Participant Flow|Lamivudine,Efavirenz,Tenofovir|Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
1183432|NCT00350272|P1|Participant Flow|Elvucitabine, Efavirenz,Tenofovir|Elvucitabine (blinded) 10 mg/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
1183433|NCT00350272|O2|Outcome|Lamivudine,Efavirenz,Tenofovir|Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
1183434|NCT00350272|O1|Outcome|Elvucitabine, Efavirenz,Tenofovir|Elvucitabine (blinded) 10 mg/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
1183435|NCT00350272|O2|Outcome|Elvucitabine|Elvucitabine (blinded) 10 mg/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
1183436|NCT00350272|O1|Outcome|Lamivudine|Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
1183437|NCT00350272|E2|Reported Event|Elvucitabine|Elvucitabine (blinded) 10 mg/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
1183438|NCT00350272|E1|Reported Event|Lamivudine|Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
1183440|NCT00350220|B2|Baseline|Low Hb (Restrictive) Group|Low Hb transfusion group; RBCs are not transfused unless the Hb <9.0 g/dl and clinical indications for transfusion are met.
1183441|NCT00350220|B1|Baseline|High Hemoglobin (Liberal) Group|High Hemoglobin group; goal Hb >13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.
1183442|NCT00350220|P2|Participant Flow|Low Hb (Restrictive) Group|Low Hb transfusion group; RBCs are not transfused unless the Hb <9.0 g/dl and clinical indications for transfusion are met.
1183443|NCT00350220|P1|Participant Flow|High Hemoglobin (Liberal) Group|High Hemoglobin group; goal Hb >13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.
1183444|NCT00350220|O2|Outcome|Low Hb (Restrictive) Group|Low Hb transfusion group; RBCs are not transfused unless the Hb <9.0 g/dl and clinical indications for transfusion are met.
1183445|NCT00350220|O1|Outcome|High Hemoglobin (Liberal) Group|High Hemoglobin group; goal Hb >13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.
1183446|NCT00350220|O2|Outcome|Low Hb (Restrictive) Group|Low Hb transfusion group; RBCs are not transfused unless the Hb <9.0 g/dl and clinical indications for transfusion are met.
1183447|NCT00350220|O1|Outcome|High Hemoglobin (Liberal) Group|High Hemoglobin group; goal Hb >13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.
1183448|NCT00350220|E2|Reported Event|Low Hb (Restrictive) Group|Low Hb transfusion group; RBCs are not transfused unless the Hb <9.0 g/dl and clinical indications for transfusion are met.
1183449|NCT00350220|E1|Reported Event|High Hemoglobin (Liberal) Group|High Hemoglobin group; goal Hb >13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.
1183450|NCT00350207|B4|Baseline|Total|Total of all reporting groups
1183451|NCT00350207|B3|Baseline|Placebo|Matching Placebo
1183452|NCT00350207|B2|Baseline|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183453|NCT00350207|B1|Baseline|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183454|NCT00350207|P3|Participant Flow|Placebo|Matching Placebo
1183455|NCT00350207|P2|Participant Flow|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183456|NCT00350207|P1|Participant Flow|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183457|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183458|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183459|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183460|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183461|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183462|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183463|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183464|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183465|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183466|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183467|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183468|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183469|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183470|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183471|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183472|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183473|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183474|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183475|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183476|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183477|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183478|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183479|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183480|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183481|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183482|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183483|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183484|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183485|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183486|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183487|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183488|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183489|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183490|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183491|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183492|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183493|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183494|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183495|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183496|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183497|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183498|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183499|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183500|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183501|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183502|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183503|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1191432|NCT00324168|B3|Baseline|Total|Total of all reporting groups
1183506|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183507|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183508|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183509|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183510|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183511|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183512|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183513|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183514|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183515|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183516|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183517|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183518|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183519|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183520|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183521|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183522|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183523|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183524|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183525|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183526|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183527|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183528|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183529|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183530|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183531|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183532|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183533|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183534|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183535|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183536|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183537|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183538|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183539|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183540|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183541|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183542|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183543|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183544|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183545|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183546|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183547|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183548|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183549|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183550|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183551|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183552|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183553|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183554|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183555|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183556|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183557|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183558|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183559|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183560|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183561|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183562|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183563|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183564|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183565|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183566|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183567|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183568|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183569|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183570|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183571|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183572|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183573|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183574|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183575|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183576|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183577|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183578|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183579|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183580|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183581|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183582|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183583|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183584|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183585|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183586|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183587|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183588|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183589|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183590|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183591|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183592|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183593|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183594|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183595|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183596|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183597|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183598|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183599|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183600|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183601|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183602|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183603|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183604|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183605|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183606|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183607|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183608|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183609|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183610|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183611|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183612|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183613|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183614|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183615|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183616|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183617|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183618|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183619|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183620|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183621|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183622|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183623|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183624|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183625|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183626|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183627|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183628|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183629|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183630|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183631|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183632|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183633|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183634|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183635|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183636|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183637|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183638|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183639|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183640|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183641|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183642|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183643|NCT00350207|O3|Outcome|Placebo|Matching Placebo
1183644|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183645|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183646|NCT00350207|E3|Reported Event|Placebo|Matching Placebo
1183647|NCT00350207|E2|Reported Event|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
1183648|NCT00350207|E1|Reported Event|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
1183649|NCT00350142|B1|Baseline|SBRT|25 Gy single fraction dose using Trilogy linear accelerator
1183650|NCT00350142|P1|Participant Flow|Stereotactic Body Radiotherapy|"patients that received a single fraction of 25 Gy Stereotactic Body Radiotherapy followed by weekly Gemcitabine administered at 1000mg/m2 over 100 minutes.~Patients will be followed at 4-6 weeks, 3 months, 6 months, 9 months and 1 year, in year 2 follow up will be every 4 months and in year 3 follow up will be every 6 months."
1183767|NCT00349388|E1|Reported Event|Asacol Once a Day Dosing|"Asacol total dose in mg/kg given once a day~Asacol: Asacol is given once a day versus twice or three times a day"
1183651|NCT00350142|O1|Outcome|Stereotactic Body Radiotherapy|"single fraction 25 Gy dose Stereotactic Body Radiotherapy on Trilogy Linear Accelerator, followed by weekly Gemcitabine~Stereotactic Body Radiotherapy: Stereotactic Body Radiotherapy will be performed using Trilogy Linear Accelerator~Gemcitabine: Weekly Gemcitabine will be administered at 1000mg/m2 over 100 minutes"
1183652|NCT00350142|O1|Outcome|Stereotactic Radiosurgery|patients w/ pancreas Cancer receiving Stereotactic Radiosurgery and Gemcitabine
1183653|NCT00350142|E1|Reported Event|SBRT With Gem|patient with locally advanced pancreas cancer receiving Gem + SBRT
1183654|NCT00350025|B3|Baseline|Total|Total of all reporting groups
1183655|NCT00350025|B2|Baseline|Arm B Paclitaxel and Cetuximab Combination Treatment Arm|"Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle. Cetuximab 250mg/m2 IV weekly for every 28 day cycle.~Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle.~Paclitaxel: Paclitaxel 80mg/m2 IV weekly for each 28 day cycle."
1183656|NCT00350025|B1|Baseline|Arm A - Cetuximab Treatment Arm|"Cetuximab 250mg/m2 IV weekly during each 28 day cycle. Arm A closed to accrual June 11, 2009 for lack of efficacy~Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle."
1183657|NCT00350025|P2|Participant Flow|Arm B Paclitaxel and Cetuximab Combination Treatment Arm|"Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle. Cetuximab 250mg/m2 IV weekly for every 28 day cycle.~Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle.~Paclitaxel: Paclitaxel 80mg/m2 IV weekly for each 28 day cycle."
1183658|NCT00350025|P1|Participant Flow|Arm A - Cetuximab Treatment Arm|"Cetuximab 250mg/m2 IV weekly during each 28 day cycle. Arm A closed to accrual June 11, 2009 for lack of efficacy~Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle."
1183659|NCT00350025|O2|Outcome|Arm B Paclitaxel and Cetuximab Combination Treatment Arm|"Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle. Cetuximab 250mg/m2 IV weekly for every 28 day cycle.~Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle.~Paclitaxel: Paclitaxel 80mg/m2 IV weekly for each 28 day cycle."
1183660|NCT00350025|O1|Outcome|Arm A - Cetuximab Treatment Arm|"Cetuximab 250mg/m2 IV weekly during each 28 day cycle. Arm A closed to accrual June 11, 2009 for lack of efficacy~Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle."
1183661|NCT00350025|O2|Outcome|Arm B Paclitaxel and Cetuximab Combination Treatment Arm|"Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle. Cetuximab 250mg/m2 IV weekly for every 28 day cycle.~Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle.~Paclitaxel: Paclitaxel 80mg/m2 IV weekly for each 28 day cycle."
1183662|NCT00350025|O1|Outcome|Arm A - Cetuximab Treatment Arm|"Cetuximab 250mg/m2 IV weekly during each 28 day cycle. Arm A closed to accrual June 11, 2009 for lack of efficacy~Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle."
1183663|NCT00350025|E2|Reported Event|Arm B Paclitaxel and Cetuximab Combination Treatment Arm|"Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle. Cetuximab 250mg/m2 IV weekly for every 28 day cycle.~Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle.~Paclitaxel: Paclitaxel 80mg/m2 IV weekly for each 28 day cycle."
1183664|NCT00350025|E1|Reported Event|Arm A - Cetuximab Treatment Arm|"Cetuximab 250mg/m2 IV weekly during each 28 day cycle. Arm A closed to accrual June 11, 2009 for lack of efficacy~Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle."
1183665|NCT00349921|B5|Baseline|Total|Total of all reporting groups
1183666|NCT00349921|B4|Baseline|Adenosine First, Then Placebo|adenosine given in first injection placebo given in second injection
1183667|NCT00349921|B3|Baseline|Clonidine Given First, Then Placebo|clonidine given first placebo given in second injection
1183668|NCT00349921|B2|Baseline|Adenosine Given First, Then Clonidine|adenosine given in first injection clonidine given in second injection
1183669|NCT00349921|B1|Baseline|Clonidine First, Then Adenosine|clonidine given in first injection adenosine given in second injection
1183670|NCT00349921|P4|Participant Flow|Adenosine First, Then Placebo|Adenosine given during the first period and placebo given during the second
1183671|NCT00349921|P3|Participant Flow|Clonidine First, Then Placebo|Clonidine given as during the first period, then placebo during the second
1183672|NCT00349921|P2|Participant Flow|Adenosine First, Then Clonidine|Adenosine given during the first period and adenosine given during the second
1183673|NCT00349921|P1|Participant Flow|Clonidine First, Then Adenosine|Clonidine given during the first period and adenosine given during the second period
1183674|NCT00349921|O3|Outcome|Placebo|Placebo received as either first or second injection
1183675|NCT00349921|O2|Outcome|Adenosine|Adenosine received as either first or second injection
1183676|NCT00349921|O1|Outcome|Clonidine|clonidine received as either first or second injection
1183677|NCT00349921|E4|Reported Event|Adenosine First, Then Placebo|adenosine given in first injection placebo given in second injection
1183678|NCT00349921|E3|Reported Event|Clonidine First, Then Placebo|clonidine given first placebo given in second injection
1183679|NCT00349921|E2|Reported Event|Adenosine First, Then Clonidine|adenosine given in first injection clonidine given in second injection
1183680|NCT00349921|E1|Reported Event|Clonidine First, Then Adenosine|clonidine given in first injection adenosine given in second injection
1183681|NCT00349908|B3|Baseline|Total|Total of all reporting groups
1183682|NCT00349908|B2|Baseline|Atherosclerosis Arm|Symptomatic stenosis in intracranial arteries
1183683|NCT00349908|B1|Baseline|Aneurysm Arm|Intracranial wide-necked aneurysms
1183684|NCT00349908|P2|Participant Flow|Atherosclerosis Arm|Symptomatic stenosis in intracranial arteries
1183685|NCT00349908|P1|Participant Flow|Aneurysm Arm|Intracranial wide-necked aneurysms
1183700|NCT00349908|E2|Reported Event|Group 2: Aneurysm Arm|This is the events from the Aneurysm Arm
1183701|NCT00349908|E1|Reported Event|Group 1: Atherosclerosis Arm|This is the events from the Atherosclerosis Arm
1183702|NCT00349752|B3|Baseline|Total|Total of all reporting groups
1183703|NCT00349752|B2|Baseline|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
1183704|NCT00349752|B1|Baseline|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
1183705|NCT00349752|P2|Participant Flow|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
1183706|NCT00349752|P1|Participant Flow|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
1183707|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
1183708|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
1183709|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
1183710|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
1183711|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
1183712|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
1183713|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
1183714|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
1183715|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
1183716|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
1183717|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
1183718|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
1183719|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
1183720|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
1183721|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
1183722|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
1183723|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
1183724|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
1183725|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
1183726|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
1183727|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
1183728|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
1183729|NCT00349752|E2|Reported Event|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
1183730|NCT00349752|E1|Reported Event|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
1183731|NCT00349622|B3|Baseline|Total|Total of all reporting groups
1183732|NCT00349622|B2|Baseline|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
1183733|NCT00349622|B1|Baseline|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
1183734|NCT00349622|P2|Participant Flow|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
1183735|NCT00349622|P1|Participant Flow|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
1183768|NCT00349349|B4|Baseline|Total|Total of all reporting groups
1184066|NCT00347932|O1|Outcome|ISV-403|Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
1183736|NCT00349622|O2|Outcome|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
1183737|NCT00349622|O1|Outcome|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
1183738|NCT00349622|O2|Outcome|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
1183739|NCT00349622|O1|Outcome|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
1183740|NCT00349622|O2|Outcome|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
1183741|NCT00349622|O1|Outcome|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
1183742|NCT00349622|O2|Outcome|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
1183743|NCT00349622|O1|Outcome|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
1183744|NCT00349622|O2|Outcome|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
1183745|NCT00349622|O1|Outcome|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
1183746|NCT00349622|O2|Outcome|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
1183747|NCT00349622|O1|Outcome|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
1183748|NCT00349622|E2|Reported Event|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
1183749|NCT00349622|E1|Reported Event|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
1183750|NCT00349466|B3|Baseline|Total|Total of all reporting groups
1183751|NCT00349466|B2|Baseline|Placebo|Placebo tablets q12 hours for 12 weeks
1183752|NCT00349466|B1|Baseline|CF101 1 mg|CF101 1 mg q12 hours
1183753|NCT00349466|P2|Participant Flow|Placebo|Placebo tablets q12 hours for 12 weeks
1183754|NCT00349466|P1|Participant Flow|CF101 1 mg|CF101 1 mg q12 hours
1183755|NCT00349466|O2|Outcome|Placebo BID|Oral tablets given every 12 hours for 12 weeks
1183756|NCT00349466|O1|Outcome|CF101 1 mg BID|Oral tablets given every 12 hours for 12 weeks
1183757|NCT00349466|E2|Reported Event|Placebo|Placebo tablets q12 hours for 12 weeks
1183758|NCT00349466|E1|Reported Event|CF101 1 mg|CF101 1 mg q12 hours
1183759|NCT00349388|B3|Baseline|Total|Total of all reporting groups
1183760|NCT00349388|B2|Baseline|Asacol BID/TID Dosing|"Asacol total dose split BID or TID~Asacol: Asacol is given once a day versus twice or three times a day"
1183761|NCT00349388|B1|Baseline|Asacol Once a Day Dosing|"Asacol total dose in mg/kg given once a day~Asacol: Asacol is given once a day versus twice or three times a day"
1183762|NCT00349388|P2|Participant Flow|Asacol BID/TID Dosing|"Asacol total dose split BID or TID~Asacol: Asacol is given once a day versus twice or three times a day"
1195561|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
1183763|NCT00349388|P1|Participant Flow|Asacol Once a Day Dosing|"Asacol total dose in mg/kg given once a day~Asacol: Asacol is given once a day versus twice or three times a day"
1183764|NCT00349388|O2|Outcome|Asacol BID/TID Dosing|"Asacol total dose split BID or TID~Asacol: Asacol is given once a day versus twice or three times a day"
1183765|NCT00349388|O1|Outcome|Asacol Once a Day Dosing|"Asacol total dose in mg/kg given once a day~Asacol: Asacol is given once a day versus twice or three times a day"
1183766|NCT00349388|E2|Reported Event|Asacol BID/TID Dosing|"Asacol total dose split BID or TID~Asacol: Asacol is given once a day versus twice or three times a day"
1183769|NCT00349349|B3|Baseline|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
1183770|NCT00349349|B2|Baseline|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
1183771|NCT00349349|B1|Baseline|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
1183772|NCT00349349|P3|Participant Flow|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
1183773|NCT00349349|P2|Participant Flow|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
1183774|NCT00349349|P1|Participant Flow|2000 mg Ofatumumab + DR|Ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The independent endpoint review committee (IRC) classified these participants as double refractory (DR), defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
1183775|NCT00349349|O1|Outcome|2000 mg Ofatumumab + Total|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. Data from all three groups of participants (DR, BFR, and Other) have been combined.
1183776|NCT00349349|O1|Outcome|2000 mg Ofatumumab + Total|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. Data from all three groups of participants (DR, BFR, and Other) have been combined.
1183777|NCT00349349|O1|Outcome|2000 mg Ofatumumab + Total|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. Data from all three groups of participants (DR, BFR, and Other) have been combined.
1183778|NCT00349349|O1|Outcome|2000 mg Ofatumumab + Total|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. Data from all three groups of participants (DR, BFR, and Other) have been combined
1183779|NCT00349349|O1|Outcome|2000 mg Ofatumumab + Total|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. Data from all three groups of participants (DR, BFR, and Other) have been combined.
1183780|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
1183781|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
1183782|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
1183783|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
1183784|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
1183785|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
1183786|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
1183787|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
1183788|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
1183873|NCT00348881|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.
1183789|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
1183790|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
1183791|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
1183792|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
1183793|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
1183794|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
1183795|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
1183796|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
1183797|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
1183798|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
1183799|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
1183800|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
1183801|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
1183802|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
1183803|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
1183804|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
1183805|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
1183806|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
1183807|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
1183808|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
1183809|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
1183810|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
1183811|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
1183812|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
1183813|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
1183814|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
1183815|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
1183816|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
1183817|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
1183818|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
1183819|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
1183820|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
1183821|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
1183822|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
1183823|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
1183824|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
1183825|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
1183826|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
1183827|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
1183828|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
1183829|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
1183830|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
1183831|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
1183832|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
1183833|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
1183834|NCT00349349|E3|Reported Event|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
1183835|NCT00349349|E2|Reported Event|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
1183836|NCT00349349|E1|Reported Event|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
1183837|NCT00349336|B3|Baseline|Total|Total of all reporting groups
1183838|NCT00349336|B2|Baseline|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
1183839|NCT00349336|B1|Baseline|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
1183840|NCT00349336|P2|Participant Flow|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
1183841|NCT00349336|P1|Participant Flow|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
1183842|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
1183843|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
1183844|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
1183845|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
1183846|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
1184061|NCT00347932|P2|Participant Flow|Vehicle|Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
1183847|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
1183874|NCT00348881|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
1184067|NCT00347932|O2|Outcome|Vehicle|Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
1183848|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
1183849|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
1183850|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
1183851|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
1183852|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
1183853|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
1183854|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
1183855|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
1183856|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
1183857|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
1183858|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
1183859|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
1183860|NCT00349336|E2|Reported Event|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
1183861|NCT00349336|E1|Reported Event|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
1183862|NCT00348933|B1|Baseline|Metafolin, Betaine, Creatine, B12 Treatment|Participants will receive two daily doses of Metafolin, betaine, and creatine, and one daily dose of vitamin B12 for 12 months.
1183863|NCT00348933|P1|Participant Flow|Metafolin, Betaine, Creatine, B12 Treatment|Participants will receive two daily doses of Metafolin, betaine, and creatine, and one daily dose of vitamin B12 for 12 months.
1183864|NCT00348933|O1|Outcome|Treatment (Metafolin/Creatine/Betaine/B12)|
1183865|NCT00348933|O1|Outcome|Treatment (Metafolin/Creatine/Betain/B12)|All participants received treatment. Compared to a placebo group from a previous study.
1183866|NCT00348933|O1|Outcome|Treatment (Metafolin/Creatine/Betaine/B12)|
1183867|NCT00348933|E1|Reported Event|Metafolin, Betaine, Creatine, B12 Treatment|Participants will receive two daily doses of Metafolin, betaine, and creatine, and one daily dose of vitamin B12 for 12 months.
1183868|NCT00348881|B3|Baseline|Total|Total of all reporting groups
1183869|NCT00348881|B2|Baseline|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.
1183870|NCT00348881|B1|Baseline|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
1183871|NCT00348881|P2|Participant Flow|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.
1183872|NCT00348881|P1|Participant Flow|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
1184064|NCT00347932|O1|Outcome|ISV-403|Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
1183875|NCT00348881|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.
1183876|NCT00348881|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
1183877|NCT00348881|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/Hib™ Concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.
1183878|NCT00348881|O1|Outcome|Group 1: DTaP-Hep B-PRP-T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP-T Concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.
1183879|NCT00348881|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with OPV vaccines at 6, 10 and 14 weeks of age.
1183880|NCT00348881|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.
1183881|NCT00348881|E2|Reported Event|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.
1183882|NCT00348881|E1|Reported Event|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
1183883|NCT00348816|B1|Baseline|Docetaxel (Single Arm)|"Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.~Adjuvant therapy: radical prostatectomy as part of standard care~Radiation therapy: Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions."
1183884|NCT00348816|P1|Participant Flow|Docetaxel (Single Arm)|"Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.~Adjuvant therapy: radical prostatectomy as part of standard care~Radiation therapy: Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions."
1183885|NCT00348816|O1|Outcome|Docetaxel (Single Arm)|Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD. Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions.
1183886|NCT00348816|E1|Reported Event|Docetaxel (Single Arm)|"Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.~Adjuvant therapy: radical prostatectomy as part of standard care~Radiation therapy: Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions."
1183887|NCT00348790|B1|Baseline|Vatalanib|"Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.~Patients who are responding may remain on study treatment for 12 months."
1183888|NCT00348790|P1|Participant Flow|Vatalanib|"Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.~Patients who are responding may remain on study treatment for 12 months."
1183889|NCT00348790|O1|Outcome|Vatalanib|"Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.~Patients who are responding may remain on study treatment for 12 months."
1183890|NCT00348790|O1|Outcome|Vatalanib|"Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.~Patients who are responding may remain on study treatment for 12 months."
1183891|NCT00348790|E1|Reported Event|Vatalanib|"Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.~Patients who are responding may remain on study treatment for 12 months.~vatalanib"
1183892|NCT00348686|B1|Baseline|Candesartan|
1183893|NCT00348686|P1|Participant Flow|Candesartan|Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
1183894|NCT00348686|O1|Outcome|Candesartan|Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
1184285|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
1183895|NCT00348686|O1|Outcome|Candesartan|Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
1183896|NCT00348686|O1|Outcome|Candesartan|Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
1183897|NCT00348686|O1|Outcome|Candesartan|Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
1183898|NCT00348686|O1|Outcome|Candesartan|Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
1183899|NCT00348686|O1|Outcome|Candesartan|Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
1183900|NCT00348686|E1|Reported Event|Candesartan|
1183901|NCT00348673|B9|Baseline|Total|Total of all reporting groups
1183902|NCT00348673|B8|Baseline|Placebo|Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1 or 3 placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
1183903|NCT00348673|B7|Baseline|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
1183904|NCT00348673|B6|Baseline|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
1183905|NCT00348673|B5|Baseline|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
1183906|NCT00348673|B4|Baseline|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
1183907|NCT00348673|B3|Baseline|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
1183908|NCT00348673|B2|Baseline|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
1183909|NCT00348673|B1|Baseline|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
1183910|NCT00348673|P9|Participant Flow|Placebo Once/Twice Daily (Stage 2)|Three placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
1183911|NCT00348673|P8|Participant Flow|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
1183912|NCT00348673|P7|Participant Flow|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
1183913|NCT00348673|P6|Participant Flow|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
1183914|NCT00348673|P5|Participant Flow|Placebo Once/Twice Daily (Stage 1)|Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
1183915|NCT00348673|P4|Participant Flow|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
1183916|NCT00348673|P3|Participant Flow|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
1183917|NCT00348673|P2|Participant Flow|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
1183918|NCT00348673|P1|Participant Flow|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
1183919|NCT00348673|O7|Outcome|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
1183920|NCT00348673|O6|Outcome|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
1183921|NCT00348673|O5|Outcome|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
1183922|NCT00348673|O4|Outcome|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
1183923|NCT00348673|O3|Outcome|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
1183924|NCT00348673|O2|Outcome|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
1183925|NCT00348673|O1|Outcome|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
1195562|NCT00313144|O1|Outcome|Year Prior to Baseline|
1183926|NCT00348673|O7|Outcome|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
1183927|NCT00348673|O6|Outcome|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
1193517|NCT00319592|B3|Baseline|Total|Total of all reporting groups
1183928|NCT00348673|O5|Outcome|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
1183929|NCT00348673|O4|Outcome|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
1183930|NCT00348673|O3|Outcome|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
1183931|NCT00348673|O2|Outcome|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
1183932|NCT00348673|O1|Outcome|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
1183933|NCT00348673|O7|Outcome|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
1183934|NCT00348673|O6|Outcome|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
1183935|NCT00348673|O5|Outcome|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
1183936|NCT00348673|O4|Outcome|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
1183937|NCT00348673|O3|Outcome|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
1183938|NCT00348673|O2|Outcome|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
1183939|NCT00348673|O1|Outcome|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
1183940|NCT00348673|O8|Outcome|Placebo|Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1 or 3 placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
1183941|NCT00348673|O7|Outcome|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
1183942|NCT00348673|O6|Outcome|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
1183943|NCT00348673|O5|Outcome|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
1183944|NCT00348673|O4|Outcome|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
1183945|NCT00348673|O3|Outcome|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
1183946|NCT00348673|O2|Outcome|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
1183947|NCT00348673|O1|Outcome|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
1183948|NCT00348673|O8|Outcome|Placebo|Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1 or 3 placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
1183949|NCT00348673|O7|Outcome|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
1183950|NCT00348673|O6|Outcome|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
1183951|NCT00348673|O5|Outcome|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
1183952|NCT00348673|O4|Outcome|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
1183953|NCT00348673|O3|Outcome|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
1183954|NCT00348673|O2|Outcome|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
1183955|NCT00348673|O1|Outcome|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
1183956|NCT00348673|E8|Reported Event|Placebo|Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1 or 3 placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
1184111|NCT00347360|B10|Baseline|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
1183957|NCT00348673|E7|Reported Event|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
1183958|NCT00348673|E6|Reported Event|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
1183959|NCT00348673|E5|Reported Event|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
1183960|NCT00348673|E4|Reported Event|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
1183961|NCT00348673|E3|Reported Event|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
1183962|NCT00348673|E2|Reported Event|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
1183963|NCT00348673|E1|Reported Event|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
1183964|NCT00348556|B1|Baseline|Nesiritide|Subjects received an intrarenal infusion of nesiritide at 0.005 microgram/kg/min for 6 hours, 0.01 microgram/kg/min for 6 hours, 0.02 microgram/kg/min for 6 hours, and 0.03 microgram/kg/min for 6 hours.
1183965|NCT00348556|P1|Participant Flow|Nesiritide|Subjects received an intrarenal infusion of nesiritide at 0.005 microgram/kg/min for 6 hours, 0.01 microgram/kg/min for 6 hours, 0.02 microgram/kg/min for 6 hours, and 0.03 microgram/kg/min for 6 hours.
1183966|NCT00348556|O1|Outcome|Nesiritide|Subjects received an intrarenal infusion of nesiritide at 0.005 microgram/kg/min for 6 hours, 0.01 microgram/kg/min for 6 hours, 0.02 microgram/kg/min for 6 hours, and 0.03 microgram/kg/min for 6 hours.
1183967|NCT00348556|O1|Outcome|Nesiritide|Subjects received an intrarenal infusion of nesiritide at 0.005 microgram/kg/min for 6 hours, 0.01 microgram/kg/min for 6 hours, 0.02 microgram/kg/min for 6 hours, and 0.03 microgram/kg/min for 6 hours.
1183968|NCT00348556|E1|Reported Event|Nesiritide|Subjects received an intrarenal infusion of nesiritide at 0.005 microgram/kg/min for 6 hours, 0.01 microgram/kg/min for 6 hours, 0.02 microgram/kg/min for 6 hours, and 0.03 microgram/kg/min for 6 hours.
1183969|NCT00348374|B3|Baseline|Total|Total of all reporting groups
1183970|NCT00348374|B2|Baseline|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
1183971|NCT00348374|B1|Baseline|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
1183972|NCT00348374|P2|Participant Flow|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
1183973|NCT00348374|P1|Participant Flow|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
1183974|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
1183975|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
1183976|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
1183977|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
1183978|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
1184057|NCT00347958|E1|Reported Event|Adacel® Vaccine Group|Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
1184058|NCT00347932|B3|Baseline|Total|Total of all reporting groups
1183979|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
1184065|NCT00347932|O2|Outcome|Vehicle|Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
1196617|NCT00308737|B1|Baseline|Technosphere® Insulin|Technosphere Insulin
1183980|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
1183981|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
1183982|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
1183983|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
1183984|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
1183985|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
1183986|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
1183987|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
1183988|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
1183989|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
1183990|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents.
1183991|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
1183992|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
1183993|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
1183994|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
1183995|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
1183996|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
1183997|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
1183998|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
1183999|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
1184000|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
1184001|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
1184002|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
1184003|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
1184004|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
1184005|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
1184006|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
1184007|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
1184008|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
1184009|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
1184010|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
1184011|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
1184059|NCT00347932|B2|Baseline|Vehicle|Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
1195563|NCT00313144|O4|Outcome|>18 Months to ≤24 Months|
1184012|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
1184013|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
1184014|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
1184015|NCT00348374|E2|Reported Event|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
1184016|NCT00348374|E1|Reported Event|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
1184017|NCT00348348|B3|Baseline|Total|Total of all reporting groups
1184018|NCT00348348|B2|Baseline|Besifloxacin Suspension|Besifloxacin ophthalmic suspension 0.6%
1184019|NCT00348348|B1|Baseline|Moxifloxacin Solution|Moxifloxacin hydrochloride ophthalmic solution 0.5%
1184020|NCT00348348|P2|Participant Flow|Besifloxacin Suspension|Besifloxacin ophthalmic suspension 0.6%
1184021|NCT00348348|P1|Participant Flow|Moxifloxacin Solution|Moxifloxacin hydrochloride ophthalmic solution 0.5%
1184022|NCT00348348|O2|Outcome|Besifloxacin Suspension|Besifloxacin ophthalmic suspension 0.6%
1184023|NCT00348348|O1|Outcome|Moxifloxacin Solution|Moxifloxacin hydrochloride ophthalmic solution 0.5%
1184024|NCT00348348|O2|Outcome|Besifloxacin Suspension|Besifloxacin ophthalmic suspension 0.6%
1184025|NCT00348348|O1|Outcome|Moxifloxacin Solution|Moxifloxacin hydrochloride ophthalmic solution 0.5%
1184026|NCT00348348|O2|Outcome|Besifloxacin Suspension|Besifloxacin ophthalmic suspension 0.6%
1184027|NCT00348348|O1|Outcome|Moxifloxacin Solution|Moxifloxacin hydrochloride ophthalmic solution 0.5%
1184028|NCT00348348|O2|Outcome|Besifloxacin Suspension|Besifloxacin ophthalmic suspension 0.6%
1184029|NCT00348348|O1|Outcome|Moxifloxacin Solution|Moxifloxacin hydrochloride ophthalmic solution 0.5%
1184030|NCT00348348|E2|Reported Event|Besifloxacin Suspension|Besifloxacin ophthalmic suspension 0.6%
1184031|NCT00348348|E1|Reported Event|Moxifloxacin Solution|Moxifloxacin hydrochloride ophthalmic solution 0.5%
1184032|NCT00348283|B3|Baseline|Total|Total of all reporting groups
1184033|NCT00348283|B2|Baseline|Adalimumab 40 mg Every Other Week|At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow.
1184034|NCT00348283|B1|Baseline|Placebo|At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow.
1184035|NCT00348283|P2|Participant Flow|Adalimumab|40 mg SC eow
1184036|NCT00348283|P1|Participant Flow|Placebo|SC dosing eow
1184037|NCT00348283|O2|Outcome|Adalimumab|40 mg every other week
1184038|NCT00348283|O1|Outcome|Placebo|
1184039|NCT00348283|O2|Outcome|Adalimumab|40 mg every other week
1184040|NCT00348283|O1|Outcome|Placebo|
1184041|NCT00348283|O2|Outcome|Adalimumab|40 mg every other week
1184042|NCT00348283|O1|Outcome|Placebo|
1184043|NCT00348283|O2|Outcome|Adalimumab|40 mg every other week
1184044|NCT00348283|O1|Outcome|Placebo|
1184045|NCT00348283|O2|Outcome|Adalimumab|40 mg every other week
1184046|NCT00348283|O1|Outcome|Placebo|
1184047|NCT00348283|O2|Outcome|Adalimumab|40 mg every other week
1184048|NCT00348283|O1|Outcome|Placebo|
1184049|NCT00348283|E2|Reported Event|Adalimumab|All subjects (135 subjects) enrolled in the study received adalimumab 160 mg at Baseline followed by adalimumab 80 mg at Week 2 (Induction dose).
1184050|NCT00348283|E1|Reported Event|Placebo|
1184051|NCT00347958|B1|Baseline|Adacel® Vaccine Group|Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
1184052|NCT00347958|P1|Participant Flow|Adacel® Vaccine Group|Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
1184053|NCT00347958|O1|Outcome|Adacel® Vaccine Group|Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
1184054|NCT00347958|O1|Outcome|Adacel® Vaccine Group|Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
1184055|NCT00347958|O1|Outcome|Adacel® Vaccine Group|Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
1184056|NCT00347958|O1|Outcome|Adacel® Vaccine Group|Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
1184060|NCT00347932|B1|Baseline|ISV-403|Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
1184062|NCT00347932|P1|Participant Flow|ISV-403|Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
1184063|NCT00347932|O2|Outcome|Vehicle|Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
1184068|NCT00347932|O1|Outcome|ISV-403|Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
1184069|NCT00347932|O2|Outcome|Vehicle|Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
1184070|NCT00347932|O1|Outcome|ISV-403|Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
1184071|NCT00347932|E2|Reported Event|Vehicle|Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
1184072|NCT00347932|E1|Reported Event|ISV-403|Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
1184073|NCT00347919|B4|Baseline|Total|Total of all reporting groups
1184074|NCT00347919|B3|Baseline|Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
1184075|NCT00347919|B2|Baseline|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
1184076|NCT00347919|B1|Baseline|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
1184077|NCT00347919|P3|Participant Flow|Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
1184078|NCT00347919|P2|Participant Flow|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
1184079|NCT00347919|P1|Participant Flow|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
1184080|NCT00347919|O1|Outcome|Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
1184081|NCT00347919|O3|Outcome|Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
1184082|NCT00347919|O2|Outcome|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
1184083|NCT00347919|O1|Outcome|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
1184084|NCT00347919|O3|Outcome|Cohort 2: Lapatinib 1500 mg/ Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
1184085|NCT00347919|O2|Outcome|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
1184086|NCT00347919|O1|Outcome|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
1184087|NCT00347919|O3|Outcome|Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
1184088|NCT00347919|O2|Outcome|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
1184089|NCT00347919|O1|Outcome|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
1184090|NCT00347919|O3|Outcome|Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
1184091|NCT00347919|O2|Outcome|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
1184092|NCT00347919|O1|Outcome|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
1184093|NCT00347919|O2|Outcome|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
1184094|NCT00347919|O1|Outcome|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
1184095|NCT00347919|E3|Reported Event|Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
1184096|NCT00347919|E2|Reported Event|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
1184097|NCT00347919|E1|Reported Event|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
1184098|NCT00347438|B1|Baseline|Capecitabine|Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
1184099|NCT00347438|P1|Participant Flow|Capecitabine|Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
1184100|NCT00347438|O1|Outcome|Capecitabine|Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
1184101|NCT00347438|O1|Outcome|Capecitabine|Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
1184102|NCT00347438|O1|Outcome|Capecitabine|Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
1184103|NCT00347438|O1|Outcome|Capecitabine|Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
1184104|NCT00347438|E1|Reported Event|Capecitabine|Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
1184105|NCT00347360|B16|Baseline|Total|Total of all reporting groups
1184106|NCT00347360|B15|Baseline|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
1184107|NCT00347360|B14|Baseline|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
1184108|NCT00347360|B13|Baseline|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
1184109|NCT00347360|B12|Baseline|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
1184110|NCT00347360|B11|Baseline|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
1184112|NCT00347360|B9|Baseline|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
1184113|NCT00347360|B8|Baseline|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
1184114|NCT00347360|B7|Baseline|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
1184115|NCT00347360|B6|Baseline|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
1184116|NCT00347360|B5|Baseline|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
1184117|NCT00347360|B4|Baseline|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
1184118|NCT00347360|B3|Baseline|Lisinopril 40|lisinopril 40 mg once daily
1184119|NCT00347360|B2|Baseline|Lisinopril 20|lisinopril 20 mg once daily
1184120|NCT00347360|B1|Baseline|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
1184121|NCT00347360|P15|Participant Flow|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
1184122|NCT00347360|P14|Participant Flow|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
1184123|NCT00347360|P13|Participant Flow|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
1184124|NCT00347360|P12|Participant Flow|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
1184125|NCT00347360|P11|Participant Flow|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
1184126|NCT00347360|P10|Participant Flow|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
1184127|NCT00347360|P9|Participant Flow|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
1184128|NCT00347360|P8|Participant Flow|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
1184129|NCT00347360|P7|Participant Flow|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
1184130|NCT00347360|P6|Participant Flow|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
1184131|NCT00347360|P5|Participant Flow|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
1184132|NCT00347360|P4|Participant Flow|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
1184133|NCT00347360|P3|Participant Flow|Lisinopril 40|lisinopril 40 mg once daily
1184134|NCT00347360|P2|Participant Flow|Lisinopril 20|lisinopril 20 mg once daily
1184135|NCT00347360|P1|Participant Flow|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
1184136|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
1184137|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
1184138|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
1184139|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
1184140|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
1184141|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
1184142|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
1184143|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
1184144|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
1184145|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
1184146|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
1184147|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
1184148|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
1184149|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
1184150|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
1184151|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
1184152|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
1184153|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
1184154|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
1184155|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
1184156|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
1184157|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
1184158|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
1184159|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
1184160|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
1184161|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
1184162|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
1184163|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
1184164|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
1184165|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
1184166|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
1184167|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
1184168|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
1184169|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
1184170|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
1184171|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
1184172|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
1184173|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
1184174|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
1184175|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
1184176|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
1184177|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
1184178|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
1184179|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
1184180|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
1184181|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
1184182|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
1184183|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
1184184|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
1184185|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
1184186|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
1184187|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
1184188|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
1184189|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
1184190|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
1184191|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
1184192|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
1184193|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
1184194|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
1184195|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
1184196|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
1184197|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
1184198|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
1184199|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
1184200|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
1184201|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
1184202|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
1184203|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
1184204|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
1184205|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
1184206|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
1184207|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
1184208|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
1184209|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
1184210|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
1184211|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
1184212|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
1184213|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
1184214|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
1184215|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
1184216|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
1184217|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
1184218|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
1184219|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
1184220|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
1184221|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
1184222|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
1184223|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
1184224|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
1184225|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
1184226|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
1184227|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
1184228|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
1184229|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
1184230|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
1184231|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
1184232|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
1184233|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
1184234|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
1184235|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
1184236|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
1184237|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
1184238|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
1184239|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
1184240|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
1184241|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
1184242|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
1184243|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
1184244|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
1184245|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
1184246|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
1184247|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
1184248|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
1184249|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
1184250|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
1184251|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
1184252|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
1184253|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
1184254|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
1184255|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
1184256|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
1184257|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
1184258|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
1184259|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
1184260|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
1184261|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
1184262|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
1184263|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
1184264|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
1184265|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
1184266|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
1184267|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
1184268|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
1184269|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
1184270|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
1184271|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
1184272|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
1184273|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
1184274|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
1184275|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
1184276|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
1184277|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
1184278|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
1184279|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
1184280|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
1184281|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
1184282|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
1184283|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
1184284|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
1184286|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
1184287|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
1184288|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
1184289|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
1184290|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
1184291|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
1184292|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
1184293|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
1184294|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
1184295|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
1184296|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
1184297|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
1184298|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
1184299|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
1184300|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
1184301|NCT00347360|E15|Reported Event|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
1184302|NCT00347360|E14|Reported Event|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
1184303|NCT00347360|E13|Reported Event|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
1184304|NCT00347360|E12|Reported Event|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
1184305|NCT00347360|E11|Reported Event|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
1184306|NCT00347360|E10|Reported Event|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
1184307|NCT00347360|E9|Reported Event|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
1184308|NCT00347360|E8|Reported Event|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
1184309|NCT00347360|E7|Reported Event|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
1184310|NCT00347360|E6|Reported Event|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
1184311|NCT00347360|E5|Reported Event|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
1184312|NCT00347360|E4|Reported Event|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
1184313|NCT00347360|E3|Reported Event|Lisinopril 40|lisinopril 40 mg once daily
1184314|NCT00347360|E2|Reported Event|Lisinopril 20|lisinopril 20 mg once daily
1184315|NCT00347360|E1|Reported Event|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
1184316|NCT00347308|B1|Baseline|Group 1|All patients entered into the study
1184317|NCT00347308|P1|Participant Flow|Group 1|All patients entered into the study
1184318|NCT00347308|O1|Outcome|Group 1|All patients entered into the study
1184319|NCT00347308|E1|Reported Event|Group 1|All patients entered into the study
1184320|NCT00347269|B3|Baseline|Total|Total of all reporting groups
1184321|NCT00347269|B2|Baseline|Treatment as Usual (TAU)|"Participants assigned to TAU with their primary care provider (PCP)~Treatment as Usual: Participants in the control group will receive standard treatment from their PCP."
1184322|NCT00347269|B1|Baseline|CALM Intervention|"Participants assigned to coordinated anxiety learning and management (CALM)--~CALM consists of: patient choice of Cognitive Behavioral Therapy (CBT), psychotropic (anti-anxiety) medication optimization or both.~Optimization: 8 weeks of an evidence based anxiety medication at appropriate dose~Cognitive-behavioral therapy: Participants in CALM will choose to receive CBT, medication, or both for the treatment of their anxiety. CBT includes computer-assisted CBT with an anxiety clinical specialist.~Psychotropic medication optimization: For those participants in CALM who choose medication, the ACS will facilitate the delivery of, and adherence to, anti-anxiety medication which will be prescribed by the participants' PCP."
1184323|NCT00347269|P2|Participant Flow|Treatment as Usual (TAU)|"Participants assigned to TAU with their primary care provider (PCP)~Treatment as Usual: Participants in the control group will receive standard treatment from their PCP."
1184324|NCT00347269|P1|Participant Flow|CALM Intervention|"Participants assigned to coordinated anxiety learning and management (CALM)--~CALM consists of: patient choice of Cognitive Behavioral Therapy (CBT), psychotropic (anti-anxiety) medication optimization or both.~Optimization: 8 weeks of an evidence based anxiety medication at appropriate dose~Cognitive-behavioral therapy: Participants in CALM will choose to receive CBT, medication, or both for the treatment of their anxiety. CBT includes computer-assisted CBT with an anxiety clinical specialist.~Psychotropic medication optimization: For those participants in CALM who choose medication, the ACS will facilitate the delivery of, and adherence to, anti-anxiety medication which will be prescribed by the participants' PCP."
1184325|NCT00347269|O2|Outcome|Treatment as Usual (TAU)|"Participants assigned to TAU with their primary care provider (PCP)~Treatment as Usual: Participants in the control group will receive standard treatment from their PCP."
1184326|NCT00347269|O1|Outcome|CALM Intervention|"Participants assigned to coordinated anxiety learning and management (CALM)--~CALM consists of: patient choice of Cognitive Behavioral Therapy (CBT), psychotropic (anti-anxiety) medication optimization or both.~Optimization: 8 weeks of an evidence based anxiety medication at appropriate dose~Cognitive-behavioral therapy: Participants in CALM will choose to receive CBT, medication, or both for the treatment of their anxiety. CBT includes computer-assisted CBT with an anxiety clinical specialist.~Psychotropic medication optimization: For those participants in CALM who choose medication, the ACS will facilitate the delivery of, and adherence to, anti-anxiety medication which will be prescribed by the participants' PCP."
1184327|NCT00347269|E2|Reported Event|Treatment as Usual (TAU)|"Participants assigned to TAU with their primary care provider (PCP)~Treatment as Usual: Participants in the control group will receive standard treatment from their PCP."
1184328|NCT00347269|E1|Reported Event|CALM Intervention|"Participants assigned to coordinated anxiety learning and management (CALM)--~CALM consists of: patient choice of Cognitive Behavioral Therapy (CBT), psychotropic (anti-anxiety) medication optimization or both.~Optimization: 8 weeks of an evidence based anxiety medication at appropriate dose~Cognitive-behavioral therapy: Participants in CALM will choose to receive CBT, medication, or both for the treatment of their anxiety. CBT includes computer-assisted CBT with an anxiety clinical specialist.~Psychotropic medication optimization: For those participants in CALM who choose medication, the ACS will facilitate the delivery of, and adherence to, anti-anxiety medication which will be prescribed by the participants' PCP."
1184329|NCT00347022|B3|Baseline|Total|Total of all reporting groups
1184330|NCT00347022|B2|Baseline|Visipaque|Patient will be injected with Visipaque 270
1184331|NCT00347022|B1|Baseline|Xenetix|Patient will be injected with Xenetix 300
1184332|NCT00347022|P2|Participant Flow|Visipaque|Patient will receive one injection of Visipaque 270
1184333|NCT00347022|P1|Participant Flow|Xenetix|Patient will receive one injection of Xenetix 300
1184334|NCT00347022|O2|Outcome|Visipaque|Patient will receive one injection of Visipaque 270
1184335|NCT00347022|O1|Outcome|Xenetix|Patient will receive one injection of Xenetix 300
1184336|NCT00347022|E2|Reported Event|Vispaque|Patient will be injected with Visipaque 270
1184337|NCT00347022|E1|Reported Event|Xenetix|Patient will be injected with Xenetix 300
1184338|NCT00347009|B1|Baseline|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
1184339|NCT00347009|P1|Participant Flow|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
1184340|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
1184341|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
1184342|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
1184343|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
1184344|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
1184345|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
1184346|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
1184347|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
1184348|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
1184349|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
1184350|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
1184351|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
1184352|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
1184353|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
1184354|NCT00347009|E1|Reported Event|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
1184355|NCT00346697|B3|Baseline|Total|Total of all reporting groups
1184356|NCT00346697|B2|Baseline|Placebo|Corn oil placebo, plus dietary counselling
1184357|NCT00346697|B1|Baseline|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
1184358|NCT00346697|P2|Participant Flow|Placebo|Corn oil placebo, plus dietary counselling
1184359|NCT00346697|P1|Participant Flow|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
1184360|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
1184361|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
1184362|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
1184363|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
1184364|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
1184365|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
1184366|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
1184367|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
1184368|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
1184369|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
1184370|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
1184371|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
1184372|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
1184373|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
1184374|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
1184375|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
1184376|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
1184377|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
1184378|NCT00346697|O2|Outcome|Placebo|"Corn oil placebo, plus dietary counselling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
1184379|NCT00346697|O1|Outcome|LOVAZA|"4 g/d of omega-3 fatty acid esters, plus dietary counseling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
1184380|NCT00346697|O2|Outcome|Placebo|"Corn oil placebo, plus dietary counselling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
1184381|NCT00346697|O1|Outcome|LOVAZA|"4 g/d of omega-3 fatty acid esters, plus dietary counseling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
1184382|NCT00346697|O2|Outcome|Placebo|"Corn oil placebo, plus dietary counselling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
1184440|NCT00346632|O13|Outcome|Arm A - 500 mg/Day: Day 1|KW2449-001 500 mg/day (Treatment Arm A)
1184383|NCT00346697|O1|Outcome|LOVAZA|"4 g/d of omega-3 fatty acid esters, plus dietary counseling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
1184384|NCT00346697|O2|Outcome|Placebo|"Corn oil placebo, plus dietary counselling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
1184385|NCT00346697|O1|Outcome|LOVAZA|"4 g/d of omega-3 fatty acid esters, plus dietary counseling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
1184386|NCT00346697|O2|Outcome|Placebo|"Corn oil placebo, plus dietary counselling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
1184387|NCT00346697|O1|Outcome|LOVAZA|"4 g/d of omega-3 fatty acid esters, plus dietary counseling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
1184388|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
1198127|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1184389|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
1184390|NCT00346697|E2|Reported Event|Placebo|"Corn oil placebo, plus dietary counselling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
1184391|NCT00346697|E1|Reported Event|LOVAZA|"4 g/d of omega-3 fatty acid esters, plus dietary counseling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
1184392|NCT00346632|B3|Baseline|Total|Total of all reporting groups
1184393|NCT00346632|B2|Baseline|Arm B: KW-2449 28-day Regimen|Sequential ascending oral doses of KW-2449 given for 28-day cycles
1184394|NCT00346632|B1|Baseline|Arm A: KW-2449 14-day Regimen|Sequential ascending oral doses of KW-2449 given for 14-day cycles
1184395|NCT00346632|P10|Participant Flow|100 mg/Day KW-2449 28-day Regimen (Arm B)|Arm B has sequential ascending oral doses of KW-2449 given for 28-day cycles
1184396|NCT00346632|P9|Participant Flow|50 mg/Day KW-2449 28-day Regimen (Arm B)|Arm B has sequential ascending oral doses of KW-2449 given for 28-day cycles
1184397|NCT00346632|P8|Participant Flow|25 mg/Day KW-2449 28-day Regimen (Arm B)|Arm B has sequential ascending oral doses of KW-2449 given for 28-day cycles
1184398|NCT00346632|P7|Participant Flow|500 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
1184399|NCT00346632|P6|Participant Flow|400 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
1184400|NCT00346632|P5|Participant Flow|300 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
1184401|NCT00346632|P4|Participant Flow|200 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
1184402|NCT00346632|P3|Participant Flow|100 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
1184403|NCT00346632|P2|Participant Flow|50 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
1184404|NCT00346632|P1|Participant Flow|25 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
1184405|NCT00346632|O12|Outcome|Arm B - Total|Total Patients in Treatment Arm B
1184406|NCT00346632|O11|Outcome|Arm B - 100 mg/Day|KW2449-001 100 mg/day (Treatment Arm B)
1184407|NCT00346632|O10|Outcome|Arm B - 50 mg/Day|KW2449-001 50 mg/day (Treatment Arm B)
1184408|NCT00346632|O9|Outcome|Arm B - 25 mg/Day|KW2449-001 25 mg/day (Treatment Arm B)
1184409|NCT00346632|O8|Outcome|Arm A - Total|Total Patients in Treatment Arm A
1184410|NCT00346632|O7|Outcome|Arm A - 500 mg/Day|KW2449-001 500 mg/day (Treatment Arm A)
1184411|NCT00346632|O6|Outcome|Arm A - 400 mg/Day|KW2449-001 400 mg/day (Treatment Arm A)
1184412|NCT00346632|O5|Outcome|Arm A - 300 mg/Day|KW2449-001 300 mg/day (Treatment Arm A)
1184413|NCT00346632|O4|Outcome|Arm A - 200 mg/Day|KW2449-001 200 mg/day (Treatment Arm A)
1184414|NCT00346632|O3|Outcome|Arm A - 100 mg/Day|KW2449-001 100 mg/day (Treatment Arm A)
1184415|NCT00346632|O2|Outcome|Arm A - 50 mg/Day|KW2449-001 50 mg/day (Treatment Arm A)
1184416|NCT00346632|O1|Outcome|Arm A - 25 mg/Day|KW2449-001 25 mg/day (Treatment Arm A)
1184417|NCT00346632|O13|Outcome|Arm B - 100 mg/Day: Day 28|KW2449-001 100 mg/day (Treatment Arm B)
1184418|NCT00346632|O12|Outcome|Arm B - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm B)
1184419|NCT00346632|O11|Outcome|Arm B - 50 mg/Day: Day 28|KW2449-001 50 mg/day (Treatment Arm B)
1184420|NCT00346632|O10|Outcome|Arm B - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm B)
1184421|NCT00346632|O9|Outcome|Arm B - 25 mg/Day: Day 28|KW2449-001 25 mg/day (Treatment Arm B)
1184422|NCT00346632|O8|Outcome|Arm B - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm B)
1184423|NCT00346632|O7|Outcome|Arm A - 500 mg/Day: Day 14|KW2449-001 500 mg/day (Treatment Arm A)
1184424|NCT00346632|O6|Outcome|Arm A - 400 mg/Day: Day 14|KW2449-001 400 mg/day (Treatment Arm A)
1184425|NCT00346632|O5|Outcome|Arm A - 300 mg/Day: Day 14|KW2449-001 300 mg/day (Treatment Arm A)
1184426|NCT00346632|O4|Outcome|Arm A - 200 mg/Day: Day 14|KW2449-001 200 mg/day (Treatment Arm A)
1184427|NCT00346632|O3|Outcome|Arm A - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm A)
1184428|NCT00346632|O2|Outcome|Arm A - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm A)
1184429|NCT00346632|O1|Outcome|Arm A - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm A)
1184430|NCT00346632|O23|Outcome|Arm B - 100 mg/Day: Day 28|KW2449-001 100 mg/day (Treatment Arm B)
1184431|NCT00346632|O22|Outcome|Arm B - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm B)
1184432|NCT00346632|O21|Outcome|Arm B - 100 mg.Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
1184433|NCT00346632|O20|Outcome|Arm B - 50 mg/Day: Day 28|KW2449-001 50 mg/day (Treatment Arm B)
1184434|NCT00346632|O19|Outcome|Arm B - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm B)
1184435|NCT00346632|O18|Outcome|Arm B - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm B)
1184436|NCT00346632|O17|Outcome|Arm B - 25 mg/Day: Day 28|KW2449-001 25 mg/day (Treatment Arm B)
1184437|NCT00346632|O16|Outcome|Arm B - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm B)
1184438|NCT00346632|O15|Outcome|Arm B - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm B)
1184439|NCT00346632|O14|Outcome|Arm A - 500 mg/Day: Day 14|KW2449-001 500 mg/day (Treatment Arm A)
1184441|NCT00346632|O12|Outcome|Arm A - 400 mg/Day: Day 14|KW2449-001 400 mg/day (Treatment Arm A)
1184442|NCT00346632|O11|Outcome|Arm A - 400 mg/Day: Day 1|KW2449-001 400 mg/day (Treatment Arm A)
1184443|NCT00346632|O10|Outcome|Arm A - 300 mg/Day: Day 14|KW2449-001 300 mg/day (Treatment Arm A)
1184444|NCT00346632|O9|Outcome|Arm A - 300 mg/Day: Day 1|KW2449-001 300 mg/day (Treatment Arm A)
1184445|NCT00346632|O8|Outcome|Arm A - 200 mg/Day: Day 14|KW2449-001 200 mg/day (Treatment Arm A)
1184446|NCT00346632|O7|Outcome|Arm A - 200 mg/Day: Day 1|KW2449-001 200 mg/day (Treatment Arm A)
1184447|NCT00346632|O6|Outcome|Arm A - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm A)
1184448|NCT00346632|O5|Outcome|Arm A - 100 mg/Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
1184449|NCT00346632|O4|Outcome|Arm A - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm A)
1184450|NCT00346632|O3|Outcome|Arm A - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm A)
1184451|NCT00346632|O2|Outcome|Arm A - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm A)
1184452|NCT00346632|O1|Outcome|Arm A - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm A)
1184453|NCT00346632|O23|Outcome|Arm B - 100 mg/Day: Day 28|KW2449-001 100 mg/day (Treatment Arm B)
1184454|NCT00346632|O22|Outcome|Arm B - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm B)
1184455|NCT00346632|O21|Outcome|Arm B - 100 mg.Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
1184456|NCT00346632|O20|Outcome|Arm B - 50 mg/Day: Day 28|KW2449-001 50 mg/day (Treatment Arm B)
1184457|NCT00346632|O19|Outcome|Arm B - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm B)
1184458|NCT00346632|O18|Outcome|Arm B - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm B)
1184459|NCT00346632|O17|Outcome|Arm B - 25 mg/Day: Day 28|KW2449-001 25 mg/day (Treatment Arm B)
1184460|NCT00346632|O16|Outcome|Arm B - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm B)
1184461|NCT00346632|O15|Outcome|Arm B - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm B)
1184462|NCT00346632|O14|Outcome|Arm A - 500 mg/Day: Day 14|KW2449-001 500 mg/day (Treatment Arm A)
1184463|NCT00346632|O13|Outcome|Arm A - 500 mg/Day: Day 1|KW2449-001 500 mg/day (Treatment Arm A)
1184464|NCT00346632|O12|Outcome|Arm A - 400 mg/Day: Day 14|KW2449-001 400 mg/day (Treatment Arm A)
1184465|NCT00346632|O11|Outcome|Arm A - 400 mg/Day: Day 1|KW2449-001 400 mg/day (Treatment Arm A)
1184466|NCT00346632|O10|Outcome|Arm A - 300 mg/Day: Day 14|KW2449-001 300 mg/day (Treatment Arm A)
1184467|NCT00346632|O9|Outcome|Arm A - 300 mg/Day: Day 1|KW2449-001 300 mg/day (Treatment Arm A)
1184468|NCT00346632|O8|Outcome|Arm A - 200 mg/Day: Day 14|KW2449-001 200 mg/day (Treatment Arm A)
1184469|NCT00346632|O7|Outcome|Arm A - 200 mg/Day: Day 1|KW2449-001 200 mg/day (Treatment Arm A)
1184470|NCT00346632|O6|Outcome|Arm A - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm A)
1184471|NCT00346632|O5|Outcome|Arm A - 100 mg/Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
1184472|NCT00346632|O4|Outcome|Arm A - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm A)
1184473|NCT00346632|O3|Outcome|Arm A - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm A)
1184474|NCT00346632|O2|Outcome|Arm A - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm A)
1184475|NCT00346632|O1|Outcome|Arm A - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm A)
1184476|NCT00346632|O23|Outcome|Arm B - 100 mg/Day: Day 28|KW2449-001 100 mg/day (Treatment Arm B)
1184477|NCT00346632|O22|Outcome|Arm B - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm B)
1184478|NCT00346632|O21|Outcome|Arm B - 100 mg.Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
1184479|NCT00346632|O20|Outcome|Arm B - 50 mg/Day: Day 28|KW2449-001 50 mg/day (Treatment Arm B)
1184480|NCT00346632|O19|Outcome|Arm B - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm B)
1184481|NCT00346632|O18|Outcome|Arm B - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm B)
1184482|NCT00346632|O17|Outcome|Arm B - 25 mg/Day: Day 28|KW2449-001 25 mg/day (Treatment Arm B)
1184483|NCT00346632|O16|Outcome|Arm B - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm B)
1184484|NCT00346632|O15|Outcome|Arm B - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm B)
1184485|NCT00346632|O14|Outcome|Arm A - 500 mg/Day: Day 14|KW2449-001 500 mg/day (Treatment Arm A)
1184486|NCT00346632|O13|Outcome|Arm A - 500 mg/Day: Day 1|KW2449-001 500 mg/day (Treatment Arm A)
1184487|NCT00346632|O12|Outcome|Arm A - 400 mg/Day: Day 14|KW2449-001 400 mg/day (Treatment Arm A)
1184488|NCT00346632|O11|Outcome|Arm A - 400 mg/Day: Day 1|KW2449-001 400 mg/day (Treatment Arm A)
1184489|NCT00346632|O10|Outcome|Arm A - 300 mg/Day: Day 14|KW2449-001 300 mg/day (Treatment Arm A)
1184490|NCT00346632|O9|Outcome|Arm A - 300 mg/Day: Day 1|KW2449-001 300 mg/day (Treatment Arm A)
1184491|NCT00346632|O8|Outcome|Arm A - 200 mg/Day: Day 14|KW2449-001 200 mg/day (Treatment Arm A)
1184492|NCT00346632|O7|Outcome|Arm A - 200 mg/Day: Day 1|KW2449-001 200 mg/day (Treatment Arm A)
1184493|NCT00346632|O6|Outcome|Arm A - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm A)
1184494|NCT00346632|O5|Outcome|Arm A - 100 mg/Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
1184495|NCT00346632|O4|Outcome|Arm A - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm A)
1184496|NCT00346632|O3|Outcome|Arm A - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm A)
1184497|NCT00346632|O2|Outcome|Arm A - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm A)
1184498|NCT00346632|O1|Outcome|Arm A - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm A)
1184499|NCT00346632|O23|Outcome|Arm B - 100 mg/Day: Day 28|KW2449-001 100 mg/day (Treatment Arm B)
1184500|NCT00346632|O22|Outcome|Arm B - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm B)
1184501|NCT00346632|O21|Outcome|Arm B - 100 mg.Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
1184502|NCT00346632|O20|Outcome|Arm B - 50 mg/Day: Day 28|KW2449-001 50 mg/day (Treatment Arm B)
1184503|NCT00346632|O19|Outcome|Arm B - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm B)
1184504|NCT00346632|O18|Outcome|Arm B - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm B)
1184505|NCT00346632|O17|Outcome|Arm B - 25 mg/Day: Day 28|KW2449-001 25 mg/day (Treatment Arm B)
1195564|NCT00313144|O3|Outcome|>12 Months to ≤18 Months|
1184506|NCT00346632|O16|Outcome|Arm B - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm B)
1184507|NCT00346632|O15|Outcome|Arm B - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm B)
1184508|NCT00346632|O14|Outcome|Arm A - 500 mg/Day: Day 14|KW2449-001 500 mg/day (Treatment Arm A)
1184509|NCT00346632|O13|Outcome|Arm A - 500 mg/Day: Day 1|KW2449-001 500 mg/day (Treatment Arm A)
1184510|NCT00346632|O12|Outcome|Arm A - 400 mg/Day: Day 14|KW2449-001 400 mg/day (Treatment Arm A)
1184511|NCT00346632|O11|Outcome|Arm A - 400 mg/Day: Day 1|KW2449-001 400 mg/day (Treatment Arm A)
1184512|NCT00346632|O10|Outcome|Arm A - 300 mg/Day: Day 14|KW2449-001 300 mg/day (Treatment Arm A)
1184513|NCT00346632|O9|Outcome|Arm A - 300 mg/Day: Day 1|KW2449-001 300 mg/day (Treatment Arm A)
1184514|NCT00346632|O8|Outcome|Arm A - 200 mg/Day: Day 14|KW2449-001 200 mg/day (Treatment Arm A)
1184515|NCT00346632|O7|Outcome|Arm A - 200 mg/Day: Day 1|KW2449-001 200 mg/day (Treatment Arm A)
1184516|NCT00346632|O6|Outcome|Arm A - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm A)
1184517|NCT00346632|O5|Outcome|Arm A - 100 mg/Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
1184518|NCT00346632|O4|Outcome|Arm A - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm A)
1184519|NCT00346632|O3|Outcome|Arm A - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm A)
1184520|NCT00346632|O2|Outcome|Arm A - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm A)
1184521|NCT00346632|O1|Outcome|Arm A - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm A)
1184522|NCT00346632|O12|Outcome|Arm B - Total|Total Patients in Treatment Arm B
1184523|NCT00346632|O11|Outcome|Arm B - 100 mg/Day|KW2449-001 100 mg/day (Treatment Arm B)
1184524|NCT00346632|O10|Outcome|Arm B - 50 mg/Day|KW2449-001 50 mg/day (Treatment Arm B)
1184525|NCT00346632|O9|Outcome|Arm B - 25 mg/Day|KW2449-001 25 mg/day (Treatment Arm B)
1184526|NCT00346632|O8|Outcome|Arm A - Total|Total Patients in Treatment Arm A
1184527|NCT00346632|O7|Outcome|Arm A - 500 mg/Day|KW2449-001 500 mg/day (Treatment Arm A)
1184528|NCT00346632|O6|Outcome|Arm A - 400 mg/Day|KW2449-001 400 mg/day (Treatment Arm A)
1184529|NCT00346632|O5|Outcome|Arm A - 300 mg/Day|KW2449-001 300 mg/day (Treatment Arm A)
1184530|NCT00346632|O4|Outcome|Arm A - 200 mg/Day|KW2449-001 200 mg/day (Treatment Arm A)
1184531|NCT00346632|O3|Outcome|Arm A - 100 mg/Day|KW2449-001 100 mg/day (Treatment Arm A)
1184532|NCT00346632|O2|Outcome|Arm A - 50 mg/Day|KW2449-001 50 mg/day (Treatment Arm A)
1184533|NCT00346632|O1|Outcome|Arm A - 25 mg/Day|KW2449-001 25 mg/day (Treatment Arm A)
1184534|NCT00346632|E12|Reported Event|Arm B - Total|Total Patients in Treatment Arm B
1184535|NCT00346632|E11|Reported Event|Arm B - 100 mg/Day|KW2449-001 100 mg/day (Treatment Arm B)
1184536|NCT00346632|E10|Reported Event|Arm B - 50 mg/Day|KW2449-001 50 mg/day (Treatment Arm B)
1184537|NCT00346632|E9|Reported Event|Arm B - 25 mg/Day|KW2449-001 25 mg/day (Treatment Arm B)
1184538|NCT00346632|E8|Reported Event|Arm A - Total|Total Patients in Treatment Arm A
1184539|NCT00346632|E7|Reported Event|Arm A - 500 mg/Day|KW2449-001 500 mg/day (Treatment Arm A)
1184540|NCT00346632|E6|Reported Event|Arm A - 400 mg/Day|KW2449-001 400 mg/day (Treatment Arm A)
1184541|NCT00346632|E5|Reported Event|Arm A - 300 mg/Day|KW2449-001 300 mg/day (Treatment Arm A)
1184542|NCT00346632|E4|Reported Event|Arm A - 200 mg/Day|KW2449-001 200 mg/day (Treatment Arm A)
1184543|NCT00346632|E3|Reported Event|Arm A - 100 mg/Day|KW2449-001 100 mg/day (Treatment Arm A)
1184544|NCT00346632|E2|Reported Event|Arm A - 50 mg/Day|KW2449-001 50 mg/day (Treatment Arm A)
1184545|NCT00346632|E1|Reported Event|Arm A - 25 mg/Day|KW2449-001 25 mg/day (Treatment Arm A)
1184546|NCT00346476|B1|Baseline|Participants|Individuals in the Masiphumelele Township of Cape Town, South Africa, who have been potentially exposed to TB and/or HIV
1184547|NCT00346476|P1|Participant Flow|Participants|Individuals in the Masiphumelele Township of Cape Town, South Africa, who have been potentially exposed to TB and/or HIV
1184548|NCT00346476|O1|Outcome|Participants|Individuals in the Masiphumelele Township of Cape Town, South Africa, who have been potentially exposed to TB and/or HIV
1184549|NCT00346476|O1|Outcome|Participants|Individuals in the Masiphumelele Township of Cape Town, South Africa, who have been potentially exposed to TB and/or HIV
1184550|NCT00346476|E1|Reported Event|Participants|Individuals in the Masiphumelele Township of Cape Town, South Africa, who have been potentially exposed to TB and/or HIV
1184551|NCT00346398|B3|Baseline|Total|Total of all reporting groups
1184552|NCT00346398|B2|Baseline|Placebo|Participants were administered via the same route as the experimental group an oral placebo solution daily for 12 months. The placebo consisted of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
1184553|NCT00346398|B1|Baseline|OMIP With Timothy Grass, Cat and House Dust Mite Allergens|Participants were administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. OMIP consisted of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
1184554|NCT00346398|P2|Participant Flow|Placebo|Participants were administered via the same route as the experimental group an oral placebo solution daily for 12 months. The placebo consisted of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
1184555|NCT00346398|P1|Participant Flow|OMIP With Timothy Grass, Cat and House Dust Mite Allergens|Participants were administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. OMIP consisted of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
1184638|NCT00346151|B1|Baseline|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
1184556|NCT00346398|O2|Outcome|Placebo|Participants were administered via the same route as the experimental group an oral placebo solution daily for 12 months. The placebo consisted of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
1184557|NCT00346398|O1|Outcome|OMIP With Timothy Grass, Cat and House Dust Mite Allergens|Participants were administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. OMIP consisted of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
1184679|NCT00345878|E1|Reported Event|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
1184558|NCT00346398|O2|Outcome|Placebo|Participants were administered via the same route as the experimental group an oral placebo solution daily for 12 months. The placebo consisted of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
1184559|NCT00346398|O1|Outcome|OMIP With Timothy Grass, Cat and House Dust Mite Allergens|Participants were administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. OMIP consisted of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
1184560|NCT00346398|O2|Outcome|Placebo|Participants were administered via the same route as the experimental group an oral placebo solution daily for 12 months. The placebo consisted of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
1184561|NCT00346398|O1|Outcome|OMIP With Timothy Grass, Cat and House Dust Mite Allergens|Participants were administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. OMIP consisted of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
1184562|NCT00346398|E2|Reported Event|Placebo|Participants were administered via the same route as the experimental group an oral placebo solution daily for 12 months. The placebo consisted of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
1184563|NCT00346398|E1|Reported Event|OMIP With Timothy Grass, Cat and House Dust Mite Allergens|Participants were administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. OMIP consisted of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
1184564|NCT00346333|B3|Baseline|Total|Total of all reporting groups
1184565|NCT00346333|B2|Baseline|Lutein Plus Vitamin A|12mg Lutein plus 15,000IU Vitamin A palmitate daily
1184566|NCT00346333|B1|Baseline|Control Plus Vitamin A|cornstarch control plus 15,000IU Vitamin A palmitate daily
1184567|NCT00346333|P2|Participant Flow|Lutein Plus Vitamin A|12mg Lutein plus 15,000 IU Vitamin A palmitate daily
1184568|NCT00346333|P1|Participant Flow|Control Plus Vitamin A|cornstarch control plus 15,000 IU Vitamin A palmitate daily
1184569|NCT00346333|O2|Outcome|Lutein Plus Vitamin A|12mg Lutein plus 15,000 IU Vitamin A palmitate daily
1184570|NCT00346333|O1|Outcome|Control Plus Vitamin A|cornstarch control plus 15,000 IU Vitamin A palmitate daily
1184571|NCT00346333|O2|Outcome|Lutein Plus Vitamin A|12mg Lutein plus 15,000 IU Vitamin A palmitate daily
1184572|NCT00346333|O1|Outcome|Control Plus Vitamin A|cornstarch control plus 15,000 IU Vitamin A palmitate daily
1184573|NCT00346333|O2|Outcome|Control Plus Vitamin A|cornstarch control plus 15,000 IU Vitamin A palmitate daily
1184574|NCT00346333|O1|Outcome|Lutein Plus Vitamin A|12mg Lutein plus 15,000 IU Vitamin A palmitate daily
1184575|NCT00346333|O2|Outcome|Lutein Plus Vitamin A|12mg Lutein plus 15,000 IU Vitamin A palmitate daily
1184576|NCT00346333|O1|Outcome|Control Plus Vitamin A|cornstarch control plus 15,000 IU Vitamin A palmitate daily
1184577|NCT00346333|O2|Outcome|Lutein Plus Vitamin A|12mg Lutein plus 15,000 IU Vitamin A palmitate daily
1184578|NCT00346333|O1|Outcome|Control Plus Vitamin A|cornstarch control plus 15,000 IU Vitamin A palmitate daily
1184579|NCT00346333|E2|Reported Event|Lutein Plus Vitamin A|12mg Lutein plus 15,000IU Vitamin A daily.
1184580|NCT00346333|E1|Reported Event|Control Plus Vitamin A|Daily intake of cornstarch control plus 15,000IU Vitamin A palmitate
1184581|NCT00346268|B3|Baseline|Total|Total of all reporting groups
1184582|NCT00346268|B2|Baseline|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184583|NCT00346268|B1|Baseline|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184584|NCT00346268|P2|Participant Flow|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184585|NCT00346268|P1|Participant Flow|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184639|NCT00346151|P1|Participant Flow|Belatacept|Immunosuppressive protocol consisting of belatacept, glucocorticoids, antithymocyte globulin (ATG), and sirolimus.
1195565|NCT00313144|O2|Outcome|>6 Months to ≤12 Months|
1184586|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184587|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184644|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
1184588|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184589|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184590|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184591|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184592|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184593|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184594|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184595|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184596|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184597|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184598|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184599|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184600|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184601|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184602|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184603|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184604|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184605|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184606|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184640|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
1184607|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184608|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184609|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184610|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184611|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184612|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184613|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184614|NCT00346268|E2|Reported Event|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184615|NCT00346268|E1|Reported Event|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
1184616|NCT00346216|B4|Baseline|Total|Total of all reporting groups
1184617|NCT00346216|B3|Baseline|Naproxen|Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
1184618|NCT00346216|B2|Baseline|Ibuprofen|Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily
1184619|NCT00346216|B1|Baseline|Celecoxib|Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily
1184620|NCT00346216|P3|Participant Flow|Naproxen|Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
1184621|NCT00346216|P2|Participant Flow|Ibuprofen|Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily
1184622|NCT00346216|P1|Participant Flow|Celecoxib|Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily
1184623|NCT00346216|O3|Outcome|Naproxen|Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
1184624|NCT00346216|O2|Outcome|Ibuprofen|Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily
1184625|NCT00346216|O1|Outcome|Celecoxib|Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily
1184626|NCT00346216|O3|Outcome|Naproxen|Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
1184627|NCT00346216|O2|Outcome|Ibuprofen|Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily
1184628|NCT00346216|O1|Outcome|Celecoxib|Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily
1184629|NCT00346216|O3|Outcome|Naproxen|Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
1184630|NCT00346216|O2|Outcome|Ibuprofen|Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily
1184631|NCT00346216|O1|Outcome|Celecoxib|Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily
1184632|NCT00346216|O3|Outcome|Naproxen|Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
1184633|NCT00346216|O2|Outcome|Ibuprofen|Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily
1184634|NCT00346216|O1|Outcome|Celecoxib|Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily
1184635|NCT00346216|E3|Reported Event|Naproxen|Naproxen 375-500 mg twice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match ibuprofen 600-800 mg thrice daily.
1184636|NCT00346216|E2|Reported Event|Ibuprofen|Ibuprofen 600-800 mg thrice daily with placebo to match celecoxib 100-200 mg twice daily and placebo to match naproxen 375-500 mg twice daily
1184637|NCT00346216|E1|Reported Event|Celecoxib|Celecoxib 100-200 mg twice daily with placebo to match ibuprofen 600-800 mg thrice daily and placebo to match naproxen 375-500 mg twice daily
1184641|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
1184642|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
1184643|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
1184680|NCT00345839|B3|Baseline|Total|Total of all reporting groups
1184645|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
1184646|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
1184647|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
1184648|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
1184649|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
1184650|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
1184651|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
1184652|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
1184653|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
1184654|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
1184655|NCT00346151|E1|Reported Event|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
1184656|NCT00346034|B1|Baseline|Pregabalin|Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.
1184657|NCT00346034|P1|Participant Flow|Pregabalin|Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.
1184658|NCT00346034|O1|Outcome|Pregabalin|Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.
1184659|NCT00346034|O1|Outcome|Pregabalin|Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.
1184660|NCT00346034|E1|Reported Event|Pregabalin|Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.
1184661|NCT00345878|B3|Baseline|Total|Total of all reporting groups
1184662|NCT00345878|B2|Baseline|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
1184663|NCT00345878|B1|Baseline|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
1184664|NCT00345878|P2|Participant Flow|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
1184665|NCT00345878|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
1184666|NCT00345878|O2|Outcome|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
1184667|NCT00345878|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
1184668|NCT00345878|O2|Outcome|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
1184669|NCT00345878|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
1184670|NCT00345878|O2|Outcome|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
1184671|NCT00345878|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
1184672|NCT00345878|O2|Outcome|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
1184673|NCT00345878|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
1184674|NCT00345878|O2|Outcome|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
1184675|NCT00345878|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
1184676|NCT00345878|O2|Outcome|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
1184677|NCT00345878|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
1184678|NCT00345878|E2|Reported Event|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
1184757|NCT00345631|O1|Outcome|Roll-In|Roll-In patients were device training patients
1184681|NCT00345839|B2|Baseline|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
1184682|NCT00345839|B1|Baseline|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
1184683|NCT00345839|P2|Participant Flow|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
1184684|NCT00345839|P1|Participant Flow|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
1184685|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
1184686|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
1184687|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
1184688|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
1184689|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
1184690|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
1184691|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
1184692|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
1184693|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
1184694|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
1184695|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
1184696|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
1184697|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
1184698|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
1184699|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
1184700|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
1184701|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
1184702|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
1184703|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
1184704|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
1184705|NCT00345839|E2|Reported Event|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
1184706|NCT00345839|E1|Reported Event|Placebo|
1184707|NCT00345683|B3|Baseline|Total|Total of all reporting groups
1184708|NCT00345683|B2|Baseline|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184709|NCT00345683|B1|Baseline|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184752|NCT00345631|O3|Outcome|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
1184754|NCT00345631|O1|Outcome|Roll-In|Roll-In patients were device training patients
1195566|NCT00313144|O1|Outcome|Baseline to ≤6 Months|
1184710|NCT00345683|P2|Participant Flow|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184758|NCT00345631|O3|Outcome|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
1184711|NCT00345683|P1|Participant Flow|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184712|NCT00345683|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184713|NCT00345683|O1|Outcome|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184714|NCT00345683|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184715|NCT00345683|O1|Outcome|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184716|NCT00345683|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184717|NCT00345683|O1|Outcome|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184718|NCT00345683|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184719|NCT00345683|O1|Outcome|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184720|NCT00345683|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184721|NCT00345683|O1|Outcome|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184722|NCT00345683|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184723|NCT00345683|O1|Outcome|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184753|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
1184724|NCT00345683|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184725|NCT00345683|O1|Outcome|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184726|NCT00345683|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184727|NCT00345683|O1|Outcome|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184728|NCT00345683|E2|Reported Event|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184729|NCT00345683|E1|Reported Event|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184730|NCT00345631|B4|Baseline|Total|Total of all reporting groups
1184731|NCT00345631|B3|Baseline|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
1184732|NCT00345631|B2|Baseline|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
1184733|NCT00345631|B1|Baseline|Roll-In|Roll-In patients were device training patients
1184734|NCT00345631|P3|Participant Flow|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
1184735|NCT00345631|P2|Participant Flow|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
1184736|NCT00345631|P1|Participant Flow|Roll-In|Roll-In patients were device training patients
1184737|NCT00345631|O3|Outcome|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
1184738|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
1184739|NCT00345631|O1|Outcome|Roll-In|Roll-In patients were device training patients
1184740|NCT00345631|O3|Outcome|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
1184741|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
1184742|NCT00345631|O1|Outcome|Roll-In|Roll-In patients were device training patients
1184743|NCT00345631|O3|Outcome|Manual Compression (Not Applicable for Device Success)|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
1184744|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
1184745|NCT00345631|O1|Outcome|Roll-In|Roll-In patients were device training patients
1184746|NCT00345631|O3|Outcome|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
1184747|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
1184748|NCT00345631|O1|Outcome|Roll-In|Roll-In patients were device training patients
1184749|NCT00345631|O3|Outcome|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
1184750|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
1184751|NCT00345631|O1|Outcome|Roll-In|Roll-In patients were device training patients
1184755|NCT00345631|O3|Outcome|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
1184756|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
1184759|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
1184760|NCT00345631|O1|Outcome|Roll-In|Roll-In patients were device training patients
1184761|NCT00345631|O3|Outcome|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
1184762|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
1184763|NCT00345631|O1|Outcome|Roll-In|patients were device training patients
1184764|NCT00345631|E3|Reported Event|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
1184765|NCT00345631|E2|Reported Event|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
1184766|NCT00345631|E1|Reported Event|Roll-In|Roll-In patients were device training patients
1184767|NCT00345605|B1|Baseline|High-dose Arginine vs Low-dose Arginine Plus Buphenyl|
1184768|NCT00345605|P2|Participant Flow|Low Dose First|low dose arm 3 day wash-out followed by 7 days of: Arg 100 mg/kg/d or 2 g/m2 BSA NaPBA 500 mg/kg/d or 10 g/m2 BSA interval then: Arg 500 mg/kg/d or 10 g/m2 BSA Placebo instead of NaPBA
1184769|NCT00345605|P1|Participant Flow|High Dose First|High dose arm 3 day wash-out followed by 7 days of: Arg 500 mg/kg/d or 10 g/m2 BSA Placebo instead of NaPBA interval then: Arg 100 mg/kg/d or 2 g/m2 BSA NaPBA 500 mg/kg/d or 10 g/m2 BSA
1184770|NCT00345605|O2|Outcome|High Dose Arginine Alone|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of arginine alone; a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine
1184771|NCT00345605|O1|Outcome|Low-dose Arginine Plus Buphenyl|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine; a 3-day washout period; a 1-week treatment period of arginine alone.
1184772|NCT00345605|O2|Outcome|High Dose Arginine Alone|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of arginine alone; a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine
1184773|NCT00345605|O1|Outcome|Low-dose Arginine Plus Buphenyl|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine; a 3-day washout period; a 1-week treatment period of arginine alone.
1184774|NCT00345605|O2|Outcome|High Dose Arginine Alone|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of arginine alone; a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine
1184775|NCT00345605|O1|Outcome|Low-dose Arginine Plus Buphenyl|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine; a 3-day washout period; a 1-week treatment period of arginine alone.
1184776|NCT00345605|O2|Outcome|Low-dose Arginine Plus Buphenyl|
1184777|NCT00345605|O1|Outcome|High-dose Arginine Alone|
1184778|NCT00345605|O2|Outcome|Low-dose Arginine Plus Buphenyl|
1184779|NCT00345605|O1|Outcome|High-dose Arginine Alone|
1184780|NCT00345605|O2|Outcome|Low-dose Arginine Plus Buphenyl|
1184781|NCT00345605|O1|Outcome|High-dose Arginine Alone|
1184782|NCT00345605|O2|Outcome|High Dose Arginine Alone|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of arginine alone; a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine
1184783|NCT00345605|O1|Outcome|Low-dose Arginine Plus Buphenyl|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine; a 3-day washout period; a 1-week treatment period of arginine alone.
1184784|NCT00345605|E2|Reported Event|Low-dose Arginine Plus Buphenyl|
1184785|NCT00345605|E1|Reported Event|High-dose Arginine Alone|
1184786|NCT00345592|B3|Baseline|Total|Total of all reporting groups
1184787|NCT00345592|B2|Baseline|Traditional Arm|"Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias.~Dual (atrial and ventricular) implantable defibrillator: In hospital application of anti arrhythmic therapies via the device~Dual (atrial and ventricular) implantable defibrillator: Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment"
1184788|NCT00345592|B1|Baseline|Device Managed Arm|"Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.~Dual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed."
1184822|NCT00345540|O1|Outcome|NOV-002 Plus Carboplatin|NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.
1195567|NCT00313144|O4|Outcome|>18 Months to ≤24 Months|
1184789|NCT00345592|P2|Participant Flow|Traditional Arm|"Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias.~Dual (atrial and ventricular) implantable defibrillator: In hospital application of anti arrhythmic therapies via the device~Dual (atrial and ventricular) implantable defibrillator: Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment"
1184825|NCT00345397|P1|Participant Flow|Subjects Receiving PEC Tube|All Enrolled Subjects receiving PEC Placement
1184965|NCT00344500|B2|Baseline|Lifestyle Balance|Weight management education and counseling
1184790|NCT00345592|P1|Participant Flow|Device Managed Arm|"Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.~Dual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed."
1184791|NCT00345592|O2|Outcome|Traditional Arm|"Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias.~Dual (atrial and ventricular) implantable defibrillator: In hospital application of anti arrhythmic therapies via the device~Dual (atrial and ventricular) implantable defibrillator: Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment"
1184792|NCT00345592|O1|Outcome|Device Managed Arm|"Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.~Dual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed."
1184793|NCT00345592|E2|Reported Event|Traditional Arm|"Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias.~Dual (atrial and ventricular) implantable defibrillator: In hospital application of anti arrhythmic therapies via the device~Dual (atrial and ventricular) implantable defibrillator: Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment"
1184794|NCT00345592|E1|Reported Event|Device Managed Arm|"Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.~Dual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed."
1184795|NCT00345579|B3|Baseline|Total|Total of all reporting groups
1184796|NCT00345579|B2|Baseline|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184797|NCT00345579|B1|Baseline|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184798|NCT00345579|P2|Participant Flow|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184799|NCT00345579|P1|Participant Flow|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184800|NCT00345579|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184801|NCT00345579|O1|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184802|NCT00345579|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184803|NCT00345579|O1|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184804|NCT00345579|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184805|NCT00345579|O1|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184826|NCT00345397|O2|Outcome|SCI-Specific QoL Evaluation in Subjects Receiving PEC Tube|SCI-Specific QoL evaluation before and after device placement
1184806|NCT00345579|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184807|NCT00345579|O1|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184808|NCT00345579|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184809|NCT00345579|O1|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184810|NCT00345579|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184811|NCT00345579|O1|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184812|NCT00345579|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184813|NCT00345579|O1|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184814|NCT00345579|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184815|NCT00345579|O1|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184816|NCT00345579|E2|Reported Event|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184817|NCT00345579|E1|Reported Event|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
1184818|NCT00345540|B1|Baseline|NOV-002 Plus Carboplatin|NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.
1184819|NCT00345540|P1|Participant Flow|NOV-002 Plus Carboplatin|NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.
1184820|NCT00345540|O1|Outcome|NOV-002 Plus Carboplatin|NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.
1184821|NCT00345540|O1|Outcome|NOV-002 Plus Carboplatin|NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.
1195568|NCT00313144|O3|Outcome|>12 Months to ≤18 Months|
1184823|NCT00345540|E1|Reported Event|NOV-002 Plus Carboplatin|NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.
1184824|NCT00345397|B1|Baseline|Subjects Receiving Percutaneous Endoscopic Colostomy (PEC)|Quality of Life (QOL) evaluation before and after device placement
1184827|NCT00345397|O1|Outcome|Global SCI-QoL Score in Subjects Receiving PEC Tube|Global SCI-QoL Score before and after device placement
1184828|NCT00345397|E1|Reported Event|Subjects Receiving PEC Tube|QoL evaluation before and after device placement
1184829|NCT00345384|B3|Baseline|Total|Total of all reporting groups
1184830|NCT00345384|B2|Baseline|Dexmedetomidine|titrated IV for 24 hours post ICU
1184831|NCT00345384|B1|Baseline|Normal Saline|Standard of care
1184832|NCT00345384|P2|Participant Flow|Dexmedetomidine|Received Dexmedetomidine for 24 hours
1184833|NCT00345384|P1|Participant Flow|Normal Saline|Blinded Normal saline infusion titrated as if study drug
1184834|NCT00345384|O2|Outcome|Dexmedetomidine|"Study group to receive a continuous infusion of dexmedetomidine titrated from 0.1 - 0.5 mics/kg/h to control pain for up to 30 hours after they are admitted to an open nursing unit after discharge from the PACU or ICU~Dexmedetomidine: Dexmedetomidine titrated over 24 hours"
1184835|NCT00345384|O1|Outcome|Placebo|Control group to receive a normal saline infusion, set at a rate as if it were the active drug.
1184836|NCT00345384|O2|Outcome|Dexmedetomidine|Patient group to receive Dexmedetomidine.
1184837|NCT00345384|O1|Outcome|Placebo|Patient group to receive placebo (saline).
1184838|NCT00345384|E2|Reported Event|Study Drug Group|Dexmedetomidine titrated IV from 0.1 microgram/kg/h upto 0.5 microgram/kg/h to control pain for 24 hours post ICU
1184839|NCT00345384|E1|Reported Event|Normal Saline Group|Normal saline infused at calculated rate as if it were study drug
1184840|NCT00345371|B3|Baseline|Total|Total of all reporting groups
1184841|NCT00345371|B2|Baseline|Placebo Oral Tablet|"After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.~Placebo Oral Tablet"
1184842|NCT00345371|B1|Baseline|Topiramate|"Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.~Topiramate"
1184843|NCT00345371|P2|Participant Flow|Placebo Oral Tablet|"After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.~Placebo Oral Tablet"
1184844|NCT00345371|P1|Participant Flow|Topiramate|"Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.~Topiramate"
1184845|NCT00345371|O2|Outcome|Placebo Oral Tablet|"After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.~Placebo Oral Tablet"
1184846|NCT00345371|O1|Outcome|Topiramate|"Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.~Topiramate"
1184847|NCT00345371|O2|Outcome|Placebo Oral Tablet|"After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.~Placebo Oral Tablet"
1184848|NCT00345371|O1|Outcome|Topiramate|"Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.~Topiramate"
1184849|NCT00345371|E2|Reported Event|Placebo Oral Tablet|"After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.~Placebo Oral Tablet"
1184850|NCT00345371|E1|Reported Event|Topiramate|"Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.~Topiramate"
1184851|NCT00345293|B1|Baseline|DC/PC3 Vaccine|"3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)~autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity"
1184852|NCT00345293|P2|Participant Flow|DC/PC3- Adherent|3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and 2) pulsed with apoptotic PC3-M1 cells (control apoptotic cells) and 3) pulsed with KLH (control antigen). Maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 10^6 DCs. DCs were made from precursors isolated using the adherence method.
1184853|NCT00345293|P1|Participant Flow|DC/PC3 Vaccine-selected|3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and 2) pulsed with apoptotic PC3-M1 cells (control apoptotic cells) and 3) pulsed with KLH (control antigen). Maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 10^6 DCs. DCs were made from precursors isolated using antibodies.
1184854|NCT00345293|O1|Outcome|DC/PC3 Vaccine|"3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)~autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity"
1184855|NCT00345293|O2|Outcome|DC/PC3- Adherent|"3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)~autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells (control apoptotic cells) and pulsed with KLH (control antigen).~Dendritic cells were made from the adherent subset of peripheral blood mononuclear cells."
1184856|NCT00345293|O1|Outcome|DC/PC3 Vaccine- Selected|"3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)~autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells (control apoptotic cells) and pulsed with KLH (control antigen).~Dendritic cells were made from antibody selected cells."
1184899|NCT00345046|P3|Participant Flow|Prednisolone Acetate 1%|Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.
1184966|NCT00344500|B1|Baseline|Usual Care|Usual Care control group
1184857|NCT00345293|O1|Outcome|DC/PC3 Vaccine|"3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)~autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity"
1184858|NCT00345293|E1|Reported Event|DC/PC3 Vaccine|"3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)~autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity"
1184859|NCT00345254|B3|Baseline|Total|Total of all reporting groups
1184860|NCT00345254|B2|Baseline|Untouched Cord|The cord was untouched after delivery of the anterior shoulder and prior to extraction of the body.
1184861|NCT00345254|B1|Baseline|Severing Cord|"The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body.~severing cord: The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body."
1184862|NCT00345254|P2|Participant Flow|Untouched Cord|The cord was untouched after delivery of the anterior shoulder and prior to extraction of the body.
1184863|NCT00345254|P1|Participant Flow|Severing Cord|"The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body.~severing cord: The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body."
1184864|NCT00345254|O2|Outcome|Untouched Cord|The cord was untouched after delivery of the anterior shoulder and prior to extraction of the body.
1184865|NCT00345254|O1|Outcome|Severing Cord|"The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body.~severing cord: The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body."
1184866|NCT00345254|E2|Reported Event|Untouched Cord|The cord was untouched after delivery of the anterior shoulder and prior to extraction of the body.
1184867|NCT00345254|E1|Reported Event|Severing Cord|"The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body.~severing cord: The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body."
1184868|NCT00345176|B5|Baseline|Total|Total of all reporting groups
1184869|NCT00345176|B4|Baseline|Lutein/Zeaxanthin + DHA/EPA|lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
1184870|NCT00345176|B3|Baseline|DHA/EPA|DHA (350 mg)/EPA (650 mg)
1184871|NCT00345176|B2|Baseline|Lutein/Zeaxanthin|lutein (10mg)/zeaxanthin (2 mg)
1184872|NCT00345176|B1|Baseline|Placebo/Control|Considered control because all participants received the AREDS formulation
1184873|NCT00345176|P4|Participant Flow|Lutein/Zeaxanthin + DHA/EPA|lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
1184874|NCT00345176|P3|Participant Flow|DHA/EPA|DHA (350 mg)/EPA (650 mg)
1184875|NCT00345176|P2|Participant Flow|Lutein/Zeaxanthin|lutein (10mg)/zeaxanthin (2 mg)
1184876|NCT00345176|P1|Participant Flow|Placebo/Control|Considered control because all participants received the AREDS formulation
1184877|NCT00345176|O2|Outcome|Lutein/Zeaxanthin|Lutein main effect - includes all participants who received Lutein/Zeaxanthin
1184878|NCT00345176|O1|Outcome|No Lutein/Zeaxanthin|Lutein main effect - includes participants who did not receive Lutein/Zeaxanthin
1184879|NCT00345176|O4|Outcome|Lutein/Zeaxanthin + DHA/EPA|lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
1184880|NCT00345176|O3|Outcome|DHA/EPA|DHA (350 mg)/EPA (650 mg)
1184881|NCT00345176|O2|Outcome|Lutein/Zeaxanthin|lutein (10mg)/zeaxanthin (2 mg)
1184882|NCT00345176|O1|Outcome|Placebo/Control|Considered control because all participants received the AREDS formulation
1184883|NCT00345176|O4|Outcome|Lutein/Zeaxanthin + DHA/EPA|lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
1184884|NCT00345176|O3|Outcome|DHA/EPA|DHA (350 mg)/EPA (650 mg)
1184885|NCT00345176|O2|Outcome|Lutein/Zeaxanthin|lutein (10mg)/zeaxanthin (2 mg)
1184886|NCT00345176|O1|Outcome|Placebo/Control|Considered control because all participants received the AREDS formulation
1184887|NCT00345176|O4|Outcome|Lutein/Zeaxanthin + DHA/EPA|lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
1184888|NCT00345176|O3|Outcome|DHA/EPA|DHA (350 mg)/EPA (650 mg)
1184889|NCT00345176|O2|Outcome|Lutein/Zeaxanthin|lutein (10mg)/zeaxanthin (2 mg)
1184890|NCT00345176|O1|Outcome|Placebo/Control|Considered control because all participants received the AREDS formulation
1184891|NCT00345176|E4|Reported Event|Lutein/Zeaxanthin + DHA/EPA|lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
1184892|NCT00345176|E3|Reported Event|DHA/EPA|DHA (350 mg)/EPA (650 mg)
1184893|NCT00345176|E2|Reported Event|Lutein/Zeaxanthin|lutein (10mg)/zeaxanthin (2 mg)
1184894|NCT00345176|E1|Reported Event|Placebo/Control|Considered control because all participants received the AREDS formulation
1184895|NCT00345046|B4|Baseline|Total|Total of all reporting groups
1184896|NCT00345046|B3|Baseline|Prednisolone Acetate|"Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.~Prednisolone Acetate: Dosed four times daily decreasing to once daily over four weeks."
1184957|NCT00344682|O1|Outcome|Placebo|Placebo comparator : 5mg - 20mg PO daily over 8 weeks
1184958|NCT00344682|O2|Outcome|Memantine|memantine : memantine 5mg - 20mg PO daily
1184897|NCT00345046|B2|Baseline|EconoPred Plus|"EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.~EconoPred Plus: Prednisolone Acetate four times daily decreasing to once daily over four weeks."
1184898|NCT00345046|B1|Baseline|Pred Forte|"Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.~Pred Forte: Four drops daily decreasing to once daily over four weeks."
1198855|NCT00302718|B5|Baseline|Total|Total of all reporting groups
1184900|NCT00345046|P2|Participant Flow|EconPred Plus 1%|EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.
1184901|NCT00345046|P1|Participant Flow|Pred Forte 1%|Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.
1184902|NCT00345046|O3|Outcome|Predisolone Acetate 1%|"Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.~Prednisolone Acetate: Dosed four times daily decreasing to once daily over four weeks."
1184903|NCT00345046|O2|Outcome|Econo Pred Plus 1%|"EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.~EconoPred Plus: Prednisolone Acetate four times daily decreasing to once daily over four weeks."
1184904|NCT00345046|O1|Outcome|Pred Forte 1%|Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.
1184905|NCT00345046|E3|Reported Event|Prednisolone Acetate 1%|"Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.~Prednisolone Acetate: Dosed four times daily decreasing to once daily over four weeks."
1184906|NCT00345046|E2|Reported Event|EconoPred Plus 1%|"EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.~EconoPred Plus: Prednisolone Acetate four times daily decreasing to once daily over four weeks."
1184907|NCT00345046|E1|Reported Event|Pred Forte 1%|"Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.~Pred Forte: Four drops daily decreasing to once daily over four weeks."
1184908|NCT00345033|B3|Baseline|Total|Total of all reporting groups
1184909|NCT00345033|B2|Baseline|Placebo|Participants will take placebo for 8 weeks.
1184910|NCT00345033|B1|Baseline|Aripiprazole|Participants will take aripiprazole for 8 weeks.
1184911|NCT00345033|P2|Participant Flow|Placebo|Participants will take placebo for 8 weeks.
1184912|NCT00345033|P1|Participant Flow|Aripiprazole|Participants will take aripiprazole for 8 weeks.
1184913|NCT00345033|O2|Outcome|Placebo|Participants will take placebo for 8 weeks.
1184914|NCT00345033|O1|Outcome|Aripiprazole|Participants will take aripiprazole for 8 weeks.
1184915|NCT00345033|O2|Outcome|Placebo|Participants will take placebo for 8 weeks.
1184916|NCT00345033|O1|Outcome|Aripiprazole|Participants will take aripiprazole for 8 weeks.
1184917|NCT00345033|O2|Outcome|Placebo|Participants will take placebo for 8 weeks.
1184918|NCT00345033|O1|Outcome|Aripiprazole|Participants will take aripiprazole for 8 weeks.
1184919|NCT00345033|O2|Outcome|Placebo|Participants will take placebo for 8 weeks.
1184920|NCT00345033|O1|Outcome|Aripiprazole|Participants will take aripiprazole for 8 weeks.
1184921|NCT00345033|O2|Outcome|Placebo|Participants will take placebo for 8 weeks.
1184922|NCT00345033|O1|Outcome|Aripiprazole|Participants will take aripiprazole for 8 weeks.
1184923|NCT00345033|O2|Outcome|Placebo|Participants will take placebo for 8 weeks.
1184924|NCT00345033|O1|Outcome|Aripiprazole|Participants will take aripiprazole for 8 weeks.
1184925|NCT00345033|E2|Reported Event|Placebo|Participants will take placebo for 8 weeks.
1184926|NCT00345033|E1|Reported Event|Aripiprazole|Participants will take aripiprazole for 8 weeks.
1184927|NCT00344968|B4|Baseline|Total|Total of all reporting groups
1184928|NCT00344968|B3|Baseline|0.5 ug/Day Implant|Dose 0.5 ug/day Medidur implant
1184929|NCT00344968|B2|Baseline|0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
1184930|NCT00344968|B1|Baseline|Sham Comparator|Procedure: Standard of care laser photocoagulation
1184931|NCT00344968|P3|Participant Flow|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur implant
1184932|NCT00344968|P2|Participant Flow|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
1184933|NCT00344968|P1|Participant Flow|Sham Comparator|Procedure: Standard of care laser photocoagulation
1184934|NCT00344968|O3|Outcome|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur implant
1184935|NCT00344968|O2|Outcome|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
1184936|NCT00344968|O1|Outcome|Sham Comparator|Procedure: Standard of care laser photocoagulation
1184937|NCT00344968|O3|Outcome|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur implant
1184938|NCT00344968|O2|Outcome|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur implant
1184939|NCT00344968|O1|Outcome|Sham Comparator|Procedure: Standard of care laser photocoagulation
1184940|NCT00344968|E3|Reported Event|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur implant
1184941|NCT00344968|E2|Reported Event|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur implant
1184942|NCT00344968|E1|Reported Event|Sham Comparator|Standard of care laser photocoagulation
1184943|NCT00344773|B1|Baseline|Gefitinib|Gefitinib 250mg tablet
1184944|NCT00344773|P1|Participant Flow|Gefitinib|Gefitinib 250mg tablet
1184945|NCT00344773|O1|Outcome|Gefitinib|Gefitinib 250mg tablet
1184946|NCT00344773|O1|Outcome|Gefitinib|Gefitinib 250mg tablet
1184947|NCT00344773|O1|Outcome|Gefitinib|Gefitinib 250mg tablet
1184948|NCT00344773|E1|Reported Event|Gefitinib|Gefitinib 250mg tablet
1184949|NCT00344682|B3|Baseline|Total|Total of all reporting groups
1184950|NCT00344682|B2|Baseline|Memantine|memantine : memantine 5mg - 20mg PO daily
1184951|NCT00344682|B1|Baseline|Placebo|Placebo comparator : 5mg - 20mg PO daily over 8 weeks
1184952|NCT00344682|P2|Participant Flow|Memantine|memantine : memantine 5mg - 20mg PO daily
1184953|NCT00344682|P1|Participant Flow|Placebo|Placebo comparator : 5mg - 20mg PO daily over 8 weeks
1184954|NCT00344682|O2|Outcome|Memantine|memantine : memantine 5mg - 20mg PO daily
1184955|NCT00344682|O1|Outcome|Placebo|Placebo comparator : 5mg - 20mg PO daily over 8 weeks
1184956|NCT00344682|O2|Outcome|Memantine|memantine : memantine 5mg - 20mg PO daily
1184959|NCT00344682|O1|Outcome|Placebo|Placebo comparator : 5mg - 20mg PO daily over 8 weeks
1184960|NCT00344682|O2|Outcome|Memantine|memantine : memantine 5mg - 20mg PO daily
1184961|NCT00344682|O1|Outcome|Placebo|Placebo comparator : 5mg - 20mg PO daily over 8 weeks
1184962|NCT00344682|E2|Reported Event|Memantine|memantine : memantine 5mg - 20mg PO daily
1184963|NCT00344682|E1|Reported Event|Placebo|Placebo comparator : 5mg - 20mg PO daily over 8 weeks
1184964|NCT00344500|B3|Baseline|Total|Total of all reporting groups
1184967|NCT00344500|P3|Participant Flow|Changeover|Participants originally randomized to Usual Care who were allowed to change over to Lifestyle Balance at month 6 per their request.
1184968|NCT00344500|P2|Participant Flow|Lifestyle Balance|"Weight management education and counseling~Behavioral Weight Loss Program: Patients randomized to the behavioral weight loss program (Lifestyle Balance Program) will do the following: -Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient~Be given a 7% weight loss goal~Be assisted in obtaining a 500 calorie reduction per day~Exercise for at least 30 min/day, at least 5 days a week~Maintain weekly food and exercise diaries~Be quizzed on their knowledge of healthy eating habits and nutrition"
1184969|NCT00344500|P1|Participant Flow|Usual Care|Usual Care control group
1184970|NCT00344500|O2|Outcome|Lifestyle Balance (LB)|Behavioral Weight Loss Program
1184971|NCT00344500|O1|Outcome|Usual Care (UC)|Usual Care control group
1184972|NCT00344500|O2|Outcome|Lifestyle Balance (LB)|Behavioral Weight Loss Program
1184973|NCT00344500|O1|Outcome|Usual Care (UC)|Usual Care control group
1184974|NCT00344500|O2|Outcome|Lifestyle Balance (LB)|Behavioral Weight Loss Program
1184975|NCT00344500|O1|Outcome|Usual Care (UC)|Usual Care control group
1184976|NCT00344500|E3|Reported Event|Changeover|Participants originally randomized to Usual Care who were allowed to change over to Lifestyle Balance at month 6 per their request.
1184977|NCT00344500|E2|Reported Event|Lifestyle Balance|"Weight management education and counseling~Behavioral Weight Loss Program: Patients randomized to the behavioral weight loss program (Lifestyle Balance Program) will do the following: -Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient~Be given a 7% weight loss goal~Be assisted in obtaining a 500 calorie reduction per day~Exercise for at least 30 min/day, at least 5 days a week~Maintain weekly food and exercise diaries~Be quizzed on their knowledge of healthy eating habits and nutrition"
1184978|NCT00344500|E1|Reported Event|Usual Care|Usual Care control group
1184979|NCT00344487|B1|Baseline|Kaletra|Lopinavir/Ritonavir (Kaletra) 400/100 mgby mouth twice a day for 48 weeks
1184980|NCT00344487|P1|Participant Flow|Kaletra|Lopinavir/Ritonavir (Kaletra) 400/100 mg by mouth twice a day for 48 weeks.
1184981|NCT00344487|O1|Outcome|Kaletra|
1184982|NCT00344487|E1|Reported Event|Group 1|
1184983|NCT00344448|B3|Baseline|Total|Total of all reporting groups
1184984|NCT00344448|B2|Baseline|Placebo|Weekly subcutaneous injection of a placebo (formulated to match the commercial vial of Raptiva in appearance and content except for the active ingredient) for the first 12 weeks of the study.
1184985|NCT00344448|B1|Baseline|Raptiva|At the beginning of the first (week 1) and second (week 13) phases, all patients will receive reduced dose of the study medication determined at 0.7 mg/kg/week. During all the subsequent administrations, all patients will receive full dose of the study medication determined at 1 mg/kg/week.
1184986|NCT00344448|P2|Participant Flow|Placebo|Weekly subcutaneous injection of a placebo (formulated to match the commercial vial of Raptiva in appearance and content except for the active ingredient) for the first 12 weeks of the study.
1184987|NCT00344448|P1|Participant Flow|Raptiva|At the beginning of the first (week 1) and second (week 13) phases, all patients will receive reduced dose of the study medication determined at 0.7 mg/kg/week. During all the subsequent administrations, all patients will receive full dose of the study medication determined at 1 mg/kg/week.
1184988|NCT00344448|O2|Outcome|Placebo|Weekly subcutaneous injection of a placebo (formulated to match the commercial vial of Raptiva in appearance and content except for the active ingredient) for the first 12 weeks of the study.
1184989|NCT00344448|O1|Outcome|Raptiva|At the beginning of the first (week 1) and second (week 13) phases, all patients will receive reduced dose of the study medication determined at 0.7 mg/kg/week. During all the subsequent administrations, all patients will receive full dose of the study medication determined at 1 mg/kg/week.
1184990|NCT00344448|E2|Reported Event|Placebo|Weekly subcutaneous injection of a placebo (formulated to match the commercial vial of Raptiva in appearance and content except for the active ingredient) for the first 12 weeks of the study.
1184991|NCT00344448|E1|Reported Event|Raptiva|At the beginning of the first (week 1) and second (week 13) phases, all patients will receive reduced dose of the study medication determined at 0.7 mg/kg/week. During all the subsequent administrations, all patients will receive full dose of the study medication determined at 1 mg/kg/week.
1184992|NCT00344370|B3|Baseline|Total|Total of all reporting groups
1184993|NCT00344370|B2|Baseline|Atorvastatin 40 mg|Atorvastatin 40 mg once daily
1184994|NCT00344370|B1|Baseline|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
1184995|NCT00344370|P2|Participant Flow|Atorvastatin 40 mg|Atorvastatin 40 mg once daily
1184996|NCT00344370|P1|Participant Flow|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
1184997|NCT00344370|O2|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg once daily
1184998|NCT00344370|O1|Outcome|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
1184999|NCT00344370|O2|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg once daily
1185000|NCT00344370|O1|Outcome|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
1185001|NCT00344370|E2|Reported Event|Atorvastatin 40 mg|Atorvastatin 40 mg once daily
1185002|NCT00344370|E1|Reported Event|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
1185003|NCT00344305|B3|Baseline|Total|Total of all reporting groups
1185004|NCT00344305|B2|Baseline|Trivalent Influenza Virus Vaccine 24 to < 60 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
1185047|NCT00344175|E1|Reported Event|Pitavastatin 4 mg|Ptavastatin 4 mg once daily
1185005|NCT00344305|B1|Baseline|Trivalent Influenza Virus Vaccine 6 to < 24 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
1185006|NCT00344305|P2|Participant Flow|Trivalent Influenza Virus Vaccine 24 to < 60 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
1185007|NCT00344305|P1|Participant Flow|Trivalent Influenza Virus Vaccine 6 to < 24 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
1185008|NCT00344305|O2|Outcome|Trivalent Influenza Virus Vaccine 24 to < 60 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
1185009|NCT00344305|O1|Outcome|Trivalent Influenza Virus Vaccine 6 to < 24 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
1185010|NCT00344305|O2|Outcome|Trivalent Influenza Virus Vaccine 24 to < 60 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
1185011|NCT00344305|O1|Outcome|Trivalent Influenza Virus Vaccine 6 to < 24 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
1185012|NCT00344305|O2|Outcome|Trivalent Influenza Virus Vaccine 24 to < 60 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
1185013|NCT00344305|O1|Outcome|Trivalent Influenza Virus Vaccine 6 to < 24 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
1185014|NCT00344305|O1|Outcome|Trivalent Influenza Virus Vaccine|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
1185015|NCT00344305|O1|Outcome|Trivalent Influenza Virus Vaccine|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
1185016|NCT00344305|O1|Outcome|Trivalent Influenza Virus Vaccine|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
1185017|NCT00344305|O2|Outcome|Trivalent Influenza Virus Vaccine 24 to < 60 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
1185018|NCT00344305|O1|Outcome|Trivalent Influenza Virus Vaccine 6 to < 24 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
1185019|NCT00344305|O2|Outcome|Trivalent Influenza Virus Vaccine 24 to < 60 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
1185020|NCT00344305|O1|Outcome|Trivalent Influenza Virus Vaccine 6 to < 24 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
1185021|NCT00344305|O2|Outcome|Trivalent Influenza Virus Vaccine 24 to < 60 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
1185022|NCT00344305|O1|Outcome|Trivalent Influenza Virus Vaccine 6 to < 24 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
1185023|NCT00344305|O2|Outcome|Trivalent Influenza Virus Vaccine 24 to < 60 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
1185024|NCT00344305|O1|Outcome|Trivalent Influenza Virus Vaccine 6 to < 24 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
1185025|NCT00344305|O2|Outcome|Trivalent Influenza Virus Vaccine 24 to < 60 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
1185026|NCT00344305|O1|Outcome|Trivalent Influenza Virus Vaccine 6 to < 24 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
1185027|NCT00344305|O2|Outcome|Trivalent Influenza Virus Vaccine 24 to < 60 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
1185028|NCT00344305|O1|Outcome|Trivalent Influenza Virus Vaccine 6 to < 24 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
1185029|NCT00344305|O2|Outcome|Trivalent Influenza Virus Vaccine 24 to < 60 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
1185030|NCT00344305|O1|Outcome|Trivalent Influenza Virus Vaccine 6 to < 24 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
1185031|NCT00344305|O2|Outcome|Trivalent Influenza Virus Vaccine 24 to < 60 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
1185032|NCT00344305|O1|Outcome|Trivalent Influenza Virus Vaccine 6 to < 24 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
1185033|NCT00344305|E2|Reported Event|Trivalent Influenza Virus Vaccine 24 to < 60 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
1185034|NCT00344305|E1|Reported Event|Trivalent Influenza Virus Vaccine 6 to < 24 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
1185035|NCT00344175|B3|Baseline|Total|Total of all reporting groups
1185036|NCT00344175|B2|Baseline|Simvastatin 40mg/80mg|Simvastatin 40 mg or 80 mg once daily
1185037|NCT00344175|B1|Baseline|Pitavastatin 4 mg|Ptavastatin 4 mg once daily
1185038|NCT00344175|P2|Participant Flow|Simvastatin 40mg/80mg|Simvastatin 40 mg or 80 mg once daily
1185039|NCT00344175|P1|Participant Flow|Pitavastatin 4 mg|Ptavastatin 4 mg once daily
1185040|NCT00344175|O2|Outcome|Simvastatin 40mg/80mg|Simvastatin 40 mg or 80 mg once daily
1185041|NCT00344175|O1|Outcome|Pitavastatin 4 mg|Ptavastatin 4 mg once daily
1185042|NCT00344175|O2|Outcome|Simvastatin 40mg/80mg|Simvastatin 40 mg or 80 mg once daily
1185043|NCT00344175|O1|Outcome|Pitavastatin 4 mg|Ptavastatin 4 mg once daily
1185044|NCT00344175|O2|Outcome|Simvastatin 40mg/80mg|Simvastatin 40 mg or 80 mg once daily
1185045|NCT00344175|O1|Outcome|Pitavastatin 4 mg|Ptavastatin 4 mg once daily
1185046|NCT00344175|E2|Reported Event|Simvastatin 40mg/80mg|Simvastatin 40 mg or 80 mg once daily
1185049|NCT00344032|B2|Baseline|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
1185050|NCT00344032|B1|Baseline|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
1185051|NCT00344032|P2|Participant Flow|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
1185052|NCT00344032|P1|Participant Flow|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
1185053|NCT00344032|O2|Outcome|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
1185054|NCT00344032|O1|Outcome|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
1185055|NCT00344032|O2|Outcome|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
1185056|NCT00344032|O1|Outcome|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
1185057|NCT00344032|O2|Outcome|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
1185058|NCT00344032|O1|Outcome|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
1185059|NCT00344032|O2|Outcome|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
1185060|NCT00344032|O1|Outcome|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
1185061|NCT00344032|O2|Outcome|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
1185062|NCT00344032|O1|Outcome|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
1185063|NCT00344032|O2|Outcome|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
1185064|NCT00344032|O1|Outcome|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
1185065|NCT00344032|E2|Reported Event|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
1185066|NCT00344032|E1|Reported Event|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
1185067|NCT00343915|B3|Baseline|Total|Total of all reporting groups
1185068|NCT00343915|B2|Baseline|3-dose Engerix|subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
1185069|NCT00343915|B1|Baseline|2-dose Engerix|subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
1185070|NCT00343915|P2|Participant Flow|3-dose Engerix|subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
1185071|NCT00343915|P1|Participant Flow|2-dose Engerix|subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
1185072|NCT00343915|O2|Outcome|3-dose Engerix|subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
1185073|NCT00343915|O1|Outcome|2-dose Engerix|subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
1185074|NCT00343915|O2|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
1185075|NCT00343915|O1|Outcome|2-dose Engerix|Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
1185076|NCT00343915|O2|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively
1185077|NCT00343915|O1|Outcome|2-dose Engerix|Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
1185078|NCT00343915|O2|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
1185079|NCT00343915|O1|Outcome|2-dose Engerix|Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
1185080|NCT00343915|O2|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
1185081|NCT00343915|O1|Outcome|2-dose Engerix|Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
1185082|NCT00343915|O2|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
1185083|NCT00343915|O1|Outcome|2-dose Engerix|Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
1185084|NCT00343915|O2|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
1185085|NCT00343915|O1|Outcome|2-dose Engerix|Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
1185086|NCT00343915|O2|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively
1185087|NCT00343915|O1|Outcome|2-dose Engerix|Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
1185088|NCT00343915|O2|Outcome|3-dose Engerix|subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
1185089|NCT00343915|O1|Outcome|2-dose Engerix|subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
1185090|NCT00343915|O2|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
1185091|NCT00343915|O1|Outcome|2-dose Engerix|Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
1185092|NCT00343915|E2|Reported Event|3-dose Engerix|subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
1185120|NCT00343564|B11|Baseline|10 mg/m2 With GCSF|Phase 1 dose escalation cohort 5 with GCSF support
1185093|NCT00343915|E1|Reported Event|2-dose Engerix|subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
1185094|NCT00343889|B3|Baseline|Total|Total of all reporting groups
1185095|NCT00343889|B2|Baseline|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
1185096|NCT00343889|B1|Baseline|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
1185127|NCT00343564|B4|Baseline|5 mg/m2 Without GCSF|Phase 1 dose escalation cohort 4 without GCSF support
1185097|NCT00343889|P2|Participant Flow|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
1185098|NCT00343889|P1|Participant Flow|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
1185099|NCT00343889|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
1185100|NCT00343889|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
1185101|NCT00343889|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
1185102|NCT00343889|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
1185103|NCT00343889|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
1185104|NCT00343889|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
1185105|NCT00343889|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
1185106|NCT00343889|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
1185107|NCT00343889|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
1185108|NCT00343889|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
1185109|NCT00343889|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
1185110|NCT00343889|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
1185111|NCT00343889|E2|Reported Event|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
1185112|NCT00343889|E1|Reported Event|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
1185113|NCT00343785|B1|Baseline|Treatment (Conditioning Regimen, Transplant, GVHD Prophylaxis)|Patients receive a conditioning regimen comprising cyclophosphamide IV on days -5 to -2 and anti-thymocyte globulin IV over 4-10 hours on days -4 to -2. Patients undergo allogeneic bone marrow transplantation on day 0. Patients then receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1 hour or PO twice daily on days -1 to 50, followed by a taper until 6 months after grafting.
1185114|NCT00343785|P1|Participant Flow|Treatment (Conditioning Regimen, Transplant, GVHD Prophylaxis)|Patients receive a conditioning regimen comprising cyclophosphamide IV on days -5 to -2 and anti-thymocyte globulin IV over 4-10 hours on days -4 to -2. Patients undergo allogeneic bone marrow transplantation on day 0. Patients then receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1 hour or PO twice daily on days -1 to 50, followed by a taper until 6 months after grafting.
1185115|NCT00343785|O1|Outcome|Treatment (Conditioning Regimen, Transplant, GVHD Prophylaxis)|Patients receive a conditioning regimen comprising cyclophosphamide IV on days -5 to -2 and anti-thymocyte globulin IV over 4-10 hours on days -4 to -2. Patients undergo allogeneic bone marrow transplantation on day 0. Patients then receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1 hour or PO twice daily on days -1 to 50, followed by a taper until 6 months after grafting.
1185116|NCT00343785|O1|Outcome|Treatment (Conditioning Regimen, Transplant, GVHD Prophylaxis)|Patients receive a conditioning regimen comprising cyclophosphamide IV on days -5 to -2 and anti-thymocyte globulin IV over 4-10 hours on days -4 to -2. Patients undergo allogeneic bone marrow transplantation on day 0. Patients then receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1 hour or PO twice daily on days -1 to 50, followed by a taper until 6 months after grafting.
1185117|NCT00343785|O1|Outcome|Patients Receive a Conditioning Regimen Comprising Cyclophosph|Patients receive a conditioning regimen comprising cyclophosphamide IV on days -5 to -2 and anti-thymocyte globulin IV over 4-10 hours on days -4 to -2. Patients undergo allogeneic bone marrow transplantation on day 0. Patients then receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1 hour or PO twice daily on days -1 to 50, followed by a taper until 6 months after grafting.
1185118|NCT00343785|E1|Reported Event|Treatment (Conditioning Regimen, Transplant, GVHD Prophylaxis)|Patients receive a conditioning regimen comprising cyclophosphamide IV on days -5 to -2 and anti-thymocyte globulin IV over 4-10 hours on days -4 to -2. Patients undergo allogeneic bone marrow transplantation on day 0. Patients then receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1 hour or PO twice daily on days -1 to 50, followed by a taper until 6 months after grafting.
1185119|NCT00343564|B12|Baseline|Total|Total of all reporting groups
1185279|NCT00343252|B3|Baseline|Total|Total of all reporting groups
1185121|NCT00343564|B10|Baseline|9 mg/m2 With GCSF|Phase 1 dose escalation cohort 4 with GCSF support
1185122|NCT00343564|B9|Baseline|8 mg/m2 With GCSF|Phase 1 dose escalation cohort 3 with GCSF support
1185123|NCT00343564|B8|Baseline|7 mg/m2 With GCSF|Phase 1 dose escalation cohort 2 with GCSF support
1185124|NCT00343564|B7|Baseline|6 mg/m2 With GCSF|Phase 1 dose escalation cohort 1 with GCSF support
1185125|NCT00343564|B6|Baseline|7 mg/m2 Without GCSF|Phase 1 dose escalation cohort 6 without GCSF support
1185126|NCT00343564|B5|Baseline|6 mg/m2 Without GCSF|Phase 1 dose escalation cohort 5 without GCSF support
1185128|NCT00343564|B3|Baseline|4 mg/m2 Without GCSF|Phase 1 dose escalation cohort 3 without GCSF support
1185129|NCT00343564|B2|Baseline|3 mg/m2 Without GCSF|Phase 1 dose escalation cohort 2 without GCSF support
1185130|NCT00343564|B1|Baseline|2 mg/m2 Without GCSF|Phase 1 dose escalation cohort 1 without GCSF support
1185131|NCT00343564|P11|Participant Flow|10 mg/m2 With GCSF|Phase 1 dose escalation cohort 5 with GCSF support
1185132|NCT00343564|P10|Participant Flow|9 mg/m2 With GCSF|Phase 1 dose escalation cohort 4 with GCSF support
1185133|NCT00343564|P9|Participant Flow|8 mg/m2 With GCSF|Phase 1 dose escalation cohort 3 with GCSF support
1185134|NCT00343564|P8|Participant Flow|7 mg/m2 With GCSF|Phase 1 dose escalation cohort 2 with GCSF support
1185135|NCT00343564|P7|Participant Flow|6 mg/m2 With GCSF|Phase 1 dose escalation cohort 1 with GCSF support
1185136|NCT00343564|P6|Participant Flow|7 mg/m2 Without GCSF|Phase 1 dose escalation cohort 6 without GCSF support
1185137|NCT00343564|P5|Participant Flow|6 mg/m2 Without GCSF|Phase 1 dose escalation cohort 5 without GCSF support
1185138|NCT00343564|P4|Participant Flow|5 mg/m2 Without GCSF|Phase 1 dose escalation cohort 4 without GCSF support
1185139|NCT00343564|P3|Participant Flow|4 mg/m2 Without GCSF|Phase 1 dose escalation cohort 3 without GCSF support
1185140|NCT00343564|P2|Participant Flow|3 mg/m2 Without GCSF|Phase 1 dose escalation cohort 2 without GCSF support
1185141|NCT00343564|P1|Participant Flow|2 mg/m2 Without GCSF|Phase 1 dose escalation cohort 1 without GCSF support
1185142|NCT00343564|O2|Outcome|Dose Escalation Cohorts 7-11 (w/ GCSF)|Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support (cohorts 7,8,9,10 and 11)
1185143|NCT00343564|O1|Outcome|Dose Escalation Cohorts 1-6 (w/o GCSF)|Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support (cohorts 1,2,3,4,5 and 6).
1185144|NCT00343564|E11|Reported Event|10 mg/m2 With GCSF|Phase 1 dose escalation cohort 5 with GCSF support
1185145|NCT00343564|E10|Reported Event|9 mg/m2 With GCSF|Phase 1 dose escalation cohort 4 with GCSF support
1185146|NCT00343564|E9|Reported Event|8 mg/m2 With GCSF|Phase 1 dose escalation cohort 3 with GCSF support
1185147|NCT00343564|E8|Reported Event|7 mg/m2 With GCSF|Phase 1 dose escalation cohort 2 with GCSF support
1185148|NCT00343564|E7|Reported Event|6 mg/m2 With GCSF|Phase 1 dose escalation cohort 1 with GCSF support
1185149|NCT00343564|E6|Reported Event|7 mg/m2 Without GCSF|Phase 1 dose escalation cohort 6 without GCSF support
1185150|NCT00343564|E5|Reported Event|6 mg/m2 Without GCSF|Phase 1 dose escalation cohort 5 without GCSF support
1185151|NCT00343564|E4|Reported Event|5 mg/m2 Without GCSF|Phase 1 dose escalation cohort 4 without GCSF support
1185152|NCT00343564|E3|Reported Event|4 mg/m2 Without GCSF|Phase 1 dose escalation cohort 3 without GCSF support
1185153|NCT00343564|E2|Reported Event|3 mg/m2 Without GCSF|Phase 1 dose escalation cohort 2 without GCSF support
1185154|NCT00343564|E1|Reported Event|2 mg/m2 Without GCSF|Phase 1 dose escalation cohort 1 without GCSF support
1185155|NCT00343512|B1|Baseline|Therapeutic Intervention|Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
1185156|NCT00343512|P1|Participant Flow|Therapeutic Intervention|Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
1185157|NCT00343512|O1|Outcome|Therapeutic Intervention|Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
1185158|NCT00343512|O1|Outcome|Therapeutic Intervention|
1185159|NCT00343512|O1|Outcome|Therapeutic Intervention|Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
1185160|NCT00343512|E1|Reported Event|Therapeutic Intervention|Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
1185161|NCT00343460|B7|Baseline|Total|Total of all reporting groups
1185162|NCT00343460|B6|Baseline|Cycle 1 Aloxi 0.25 Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
1185163|NCT00343460|B5|Baseline|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
1185164|NCT00343460|B4|Baseline|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
1185165|NCT00343460|B3|Baseline|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
1185166|NCT00343460|B2|Baseline|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
1185167|NCT00343460|B1|Baseline|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
1185168|NCT00343460|P3|Participant Flow|Aloxi 0.25 mg|Aloxi 0.25 mg - Safety Population
1185169|NCT00343460|P2|Participant Flow|APF530 10 mg|APF530 10 mg - Safety Population
1185170|NCT00343460|P1|Participant Flow|APF530 5 mg|APF530 5 mg - Safety Population
1185171|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
1185172|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
1185173|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
1185174|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
1185175|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
1185378|NCT00342563|O1|Outcome|Mecamylamine|mecamylamine: mecamylamine 10mg/day
1185176|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
1185177|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
1185178|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
1185179|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
1185180|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
1185387|NCT00342563|E2|Reported Event|Mecamylamine Non-Smoker|mecamylamine: mecamylamine 10mg/day
1185181|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
1185182|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
1185183|NCT00343460|O4|Outcome|Cycles 1, 2, 3, and 4 - Highly|APF530 10 mg
1185184|NCT00343460|O3|Outcome|Cycles 1, 2, 3 and 4 - Highly|APF530 5 mg
1185185|NCT00343460|O2|Outcome|Cycles 1, 2, 3, and 4 - Moderately|APF530 10 mg
1185186|NCT00343460|O1|Outcome|Cycles 1, 2, 3 and 4 - Moderately|APF530 5 mg
1185187|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
1185188|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
1185189|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
1185190|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
1185191|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
1185192|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
1185193|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
1185194|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
1185195|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
1185196|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
1185197|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
1185198|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
1185199|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
1185200|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
1185201|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
1185202|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
1185203|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
1185204|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
1185205|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
1185206|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
1185207|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
1185208|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
1185209|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
1185210|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
1185211|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
1185212|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
1185213|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
1185214|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
1185215|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
1185216|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
1185217|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
1185218|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
1185219|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
1185220|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
1185221|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
1185222|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
1185223|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
1185224|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
1185225|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
1185226|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
1185227|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
1185228|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
1185229|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
1185230|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
1185231|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
1185232|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
1185233|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
1185234|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
1185235|NCT00343460|E5|Reported Event|Cycle 2-4 APF530 10 mg|Serious Treatment-Emergent Adverse Events - Cycles 2-4 - Safety Population
1185236|NCT00343460|E4|Reported Event|Cycles 2-4 APF530 5 mg|Serious Treatment-Emergent Adverse Events - Cycles 2-4 - Safety Population
1185237|NCT00343460|E3|Reported Event|Cycle 1 Aloxi 0.25 mg|Serious Treatment-Emergent Adverse Events - Cycle 1 - Safety Population
1185238|NCT00343460|E2|Reported Event|Cycle 1 APF530 10 mg|Serious Treatment-Emergent Adverse Events - Cycle 1 - Safety Population
1185239|NCT00343460|E1|Reported Event|Cycle 1 APF530 5 mg|Serious Treatment-Emergent Adverse Events - Cycle 1 - Safety Population
1185240|NCT00343382|B4|Baseline|Total|Total of all reporting groups
1185241|NCT00343382|B3|Baseline|Pilocarpine 4 Times Per Day|Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
1185242|NCT00343382|B2|Baseline|Pilocarpine 2 Times Per Day|Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
1185243|NCT00343382|B1|Baseline|Collective Placebo|Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
1185244|NCT00343382|P3|Participant Flow|Pilocarpine 4 Times Per Day|Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
1185245|NCT00343382|P2|Participant Flow|Pilocarpine 2 Times Per Day|Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
1185246|NCT00343382|P1|Participant Flow|Collective Placebo|Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
1185247|NCT00343382|O3|Outcome|Pilocarpine 4 Times Per Day|Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
1185248|NCT00343382|O2|Outcome|Pilocarpine 2 Times Per Day|Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
1185249|NCT00343382|O1|Outcome|Collective Placebo|Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
1185250|NCT00343382|O3|Outcome|Pilocarpine 4 Times Per Day|Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
1185251|NCT00343382|O2|Outcome|Pilocarpine 2 Times Per Day|Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
1185252|NCT00343382|O1|Outcome|Collective Placebo|Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
1185253|NCT00343382|O3|Outcome|Pilocarpine 4 Times Per Day|Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
1185254|NCT00343382|O2|Outcome|Pilocarpine 2 Times Per Day|Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
1185255|NCT00343382|O1|Outcome|Collective Placebo|Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
1185256|NCT00343382|O3|Outcome|Pilocarpine 4 Times Per Day|Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
1185257|NCT00343382|O2|Outcome|Pilocarpine 2 Times Per Day|Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
1185258|NCT00343382|O1|Outcome|Collective Placebo|Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
1185259|NCT00343382|E3|Reported Event|Collective Placebo|Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
1185260|NCT00343382|E2|Reported Event|Pilocarpine 4 Times Per Day|Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
1185261|NCT00343382|E1|Reported Event|Pilocarpine 2 Times Per Day|Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
1185262|NCT00343291|B3|Baseline|Total|Total of all reporting groups
1185263|NCT00343291|B2|Baseline|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Cycles 1-3:~Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles~Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
1185264|NCT00343291|B1|Baseline|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Paclitaxel 200mg/m² on day 1 of every 3 week cycle~Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle~Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
1185265|NCT00343291|P2|Participant Flow|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Cycles 1-3:~Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles~Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
1185280|NCT00343252|B2|Baseline|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
1185266|NCT00343291|P1|Participant Flow|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Paclitaxel 200mg/m² on day 1 of every 3 week cycle~Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle~Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
1185284|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
1199135|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
1185267|NCT00343291|O2|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Cycles 1-3:~Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles~Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
1185268|NCT00343291|O1|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Paclitaxel 200mg/m² on day 1 of every 3 week cycle~Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle~Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
1185269|NCT00343291|O2|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Cycles 1-3:~Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles~Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
1185270|NCT00343291|O1|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Paclitaxel 200mg/m² on day 1 of every 3 week cycle~Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle~Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
1185271|NCT00343291|O2|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Cycles 1-3:~Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles~Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
1185272|NCT00343291|O1|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Paclitaxel 200mg/m² on day 1 of every 3 week cycle~Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle~Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
1185273|NCT00343291|O2|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Cycles 1-3:~Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles~Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
1185274|NCT00343291|O1|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Paclitaxel 200mg/m² on day 1 of every 3 week cycle~Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle~Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
1185275|NCT00343291|O2|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Cycles 1-3:~Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles~Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
1185276|NCT00343291|O1|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Paclitaxel 200mg/m² on day 1 of every 3 week cycle~Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle~Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
1185277|NCT00343291|E2|Reported Event|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Cycles 1-3:~Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles~Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
1185278|NCT00343291|E1|Reported Event|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Paclitaxel 200mg/m² on day 1 of every 3 week cycle~Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle~Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
1185281|NCT00343252|B1|Baseline|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
1185282|NCT00343252|P2|Participant Flow|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
1185283|NCT00343252|P1|Participant Flow|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
1185386|NCT00342563|E3|Reported Event|Placebo Smoker|Placebo: Placebo
1185285|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
1185286|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
1185287|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
1185288|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
1185289|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
1185290|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
1185291|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
1185292|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
1185293|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
1185294|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
1185295|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
1185296|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
1185297|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
1185298|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
1185299|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
1185300|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
1185301|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
1185302|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
1185303|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
1185304|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
1185305|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
1185306|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
1185307|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
1185308|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
1185309|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
1185310|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
1185311|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
1185312|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
1185313|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
1185314|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
1185315|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
1185316|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
1185317|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
1185318|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
1185319|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
1185320|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
1185321|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
1185322|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
1185323|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
1185324|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
1185325|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
1185326|NCT00343252|E2|Reported Event|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
1185327|NCT00343252|E1|Reported Event|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
1185328|NCT00343083|B1|Baseline|Cetuximab (ERBITUX) and Concurrent Carboplatin|
1185377|NCT00342563|O2|Outcome|Placebo|Placebo: Placebo
1185329|NCT00343083|P1|Participant Flow|Cetuximab (ERBITUX) and Concurrent Carboplatin|". Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy. Chemotherapy will be given every week for a total of 8 weeks. Paclitaxel will be given at a dose of 40 mg/m2 as a 1 hour infusion dose followed by cetuximab and then carboplatin AUC = 2/week.~The initial dose of cetuximab is 400 mg/m2 IV on day 1, followed by weekly infusions at 250 mg/m2 IV."
1185330|NCT00343083|O1|Outcome|Concurrent Chemo Raditaion Wtih Cetuximab|The addition of CTX to weekly PC and daily RT
1199136|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
1185331|NCT00343083|O1|Outcome|Concurrent Chemo Raditaion Wtih Cetuximab|The addition of CTX to weekly PC and daily RT
1185332|NCT00343083|O1|Outcome|Concurrent Chemo Raditaion Wtih Cetuximab|The addition of CTX to weekly PC and daily RT
1185333|NCT00343083|O1|Outcome|Concurrent Chemo Raditaion Wtih Cetuximab|The addition of CTX to weekly PC and daily RT.
1185334|NCT00343083|O1|Outcome|Concurrent Chemo Raditaion Wtih Cetuximab|The addition of CTX to weekly PC and daily RT.
1185335|NCT00343083|O1|Outcome|Concurrent Chemo Raditaion Wtih Cetuximab|The addition of CTX to weekly PC and daily RT.
1185336|NCT00343083|E1|Reported Event|Cetuximab (ERBITUX) and Concurrent Carboplatin|
1185337|NCT00343044|B1|Baseline|Combined Weekly Topotecan and Biweekly Bevacizumab|Treatment was administered in 28 day cycles, with IV bevacizumab 10 mg/kg given on days 1 and 15 and IV topotecan 4 mg/m2 given on days 1 and 8. Treatment was continued until progressive disease defined by RECIST, symptomatic deterioration related to clinical progression, excessive toxicity. Dose reductions of bevacizumab were not permitted.
1185338|NCT00343044|P1|Participant Flow|Combined Weekly Topotecan and Biweekly Bevacizumab|Treatment was administered in 28 day cycles, with IV bevacizumab 10 mg/kg given on days 1 and 15 and IV topotecan 4 mg/m2 given on days 1 and 8. Treatment was continued until progressive disease defined by RECIST, symptomatic deterioration related to clinical progression, excessive toxicity. Dose reductions of bevacizumab were not permitted.
1185339|NCT00343044|O1|Outcome|Combined Weekly Topotecan and Biweekly Bevacizumab|Treatment was administered in 28 day cycles, with IV bevacizumab 10 mg/kg given on days 1 and 15 and IV topotecan 4 mg/m2 given on days 1 and 8. Treatment was continued until progressive disease defined by RECIST, symptomatic deterioration related to clinical progression, excessive toxicity. Dose reductions of bevacizumab were not permitted.
1185340|NCT00343044|O1|Outcome|Combined Weekly Topotecan and Biweekly Bevacizumab|Treatment was administered in 28 day cycles, with IV bevacizumab 10 mg/kg given on days 1 and 15 and IV topotecan 4 mg/m2 given on days 1 and 8. Treatment was continued until progressive disease defined by RECIST, symptomatic deterioration related to clinical progression, excessive toxicity. Dose reductions of bevacizumab were not permitted.
1185341|NCT00343044|O1|Outcome|Combined Weekly Topotecan and Biweekly Bevacizumab|Treatment was administered in 28 day cycles, with IV bevacizumab 10 mg/kg given on days 1 and 15 and IV topotecan 4 mg/m2 given on days 1 and 8. Treatment was continued until progressive disease defined by RECIST, symptomatic deterioration related to clinical progression, excessive toxicity. Dose reductions of bevacizumab were not permitted.
1185342|NCT00343044|O1|Outcome|Combined Weekly Topotecan and Biweekly Bevacizumab|Treatment was administered in 28 day cycles, with IV bevacizumab 10 mg/kg given on days 1 and 15 and IV topotecan 4 mg/m2 given on days 1 and 8. Treatment was continued until progressive disease defined by RECIST, symptomatic deterioration related to clinical progression, excessive toxicity. Dose reductions of bevacizumab were not permitted.
1185343|NCT00343044|E1|Reported Event|Arm 1|Patients (N=40)
1185344|NCT00342628|B4|Baseline|Total|Total of all reporting groups
1185345|NCT00342628|B3|Baseline|DTP Vaccines|DTP at 2, 4, and 6 months of age
1185346|NCT00342628|B2|Baseline|Hib-TT Plus DTP|Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
1185347|NCT00342628|B1|Baseline|Vi-rEPA Plus DTP|Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
1185348|NCT00342628|P3|Participant Flow|DTP Vaccines|DTP at 2, 4, and 6 months of age
1185349|NCT00342628|P2|Participant Flow|Hib-TT Plus DTP|Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
1185350|NCT00342628|P1|Participant Flow|Vi-rEPA Plus DTP|Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
1185351|NCT00342628|O3|Outcome|DTP Vaccines|DTP at 2, 4, and 6 months of age
1185352|NCT00342628|O2|Outcome|Hib-TT Plus DTP|Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
1185353|NCT00342628|O1|Outcome|Vi-rEPA Plus DTP|Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
1185354|NCT00342628|O3|Outcome|DTP Vaccines|DTP at 2, 4, and 6 months of age
1185355|NCT00342628|O2|Outcome|Hib-TT Plus DTP|Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
1185356|NCT00342628|O1|Outcome|Vi-rEPA Plus DTP|Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
1185357|NCT00342628|O3|Outcome|DTP Vaccines|DTP at 2, 4, and 6 months of age
1185358|NCT00342628|O2|Outcome|Hib-TT Plus DTP|Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
1185359|NCT00342628|O1|Outcome|Vi-rEPA Plus DTP|Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
1185360|NCT00342628|O3|Outcome|DTP Vaccines|DTP at 2, 4, and 6 months of age
1185361|NCT00342628|O2|Outcome|Hib-TT Plus DTP|Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
1185362|NCT00342628|O1|Outcome|Vi-rEPA Plus DTP|Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
1185363|NCT00342628|E3|Reported Event|DTP Vaccines|DTP at 2, 4, and 6 months of age
1185364|NCT00342628|E2|Reported Event|Hib-TT Plus DTP|Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
1185365|NCT00342628|E1|Reported Event|Vi-rEPA Plus DTP|Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
1185366|NCT00342563|B5|Baseline|Total|Total of all reporting groups
1185367|NCT00342563|B4|Baseline|Placebo- Non-Smoker|
1185368|NCT00342563|B3|Baseline|Placebo-Smoker|Placebo: Placebo
1185369|NCT00342563|B2|Baseline|Mecamylamine-Non-Smoker|
1185370|NCT00342563|B1|Baseline|Mecamylamine-Smoker|mecamylamine: mecamylamine 10mg/day
1185371|NCT00342563|P4|Participant Flow|Placebo Non-Smoker|
1185372|NCT00342563|P3|Participant Flow|Placebo Smoker|
1185373|NCT00342563|P2|Participant Flow|Mecamylamine Non-Smoker|
1185374|NCT00342563|P1|Participant Flow|Mecamylamine- Smoker|mecamylamine: mecamylamine 10mg/day
1185375|NCT00342563|O2|Outcome|Placebo|Placebo: Placebo
1185376|NCT00342563|O1|Outcome|Mecamylamine|mecamylamine: mecamylamine 10mg/day
1185380|NCT00342563|O1|Outcome|Mecamylamine|mecamylamine: mecamylamine 10mg/day
1185381|NCT00342563|O4|Outcome|Placebo- Non-Smoker|
1185382|NCT00342563|O3|Outcome|Placebo-Smoker|Placebo
1185383|NCT00342563|O2|Outcome|Mecamylamine- Non-Smoker|mecamylamine: mecamylamine 10mg/day
1185384|NCT00342563|O1|Outcome|Mecamylamine- Smokers|mecamylamine: mecamylamine 10mg/day
1185385|NCT00342563|E4|Reported Event|Placebo Non-Smoker|Placebo: Placebo
1185388|NCT00342563|E1|Reported Event|Mecamylamine Smoker|mecamylamine: mecamylamine 10mg/day
1185389|NCT00342355|B5|Baseline|Total|Total of all reporting groups
1185390|NCT00342355|B4|Baseline|d4T + 3TC + r/LPV|Stavudine + Lamivudine + lopinavir/ritonavir
1185391|NCT00342355|B3|Baseline|d4T + 3TC + EFV|Stavudine + Lamivudine + efavirenz
1185392|NCT00342355|B2|Baseline|AZT + ddI + r/LPV|Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV]
1185393|NCT00342355|B1|Baseline|AZT+ddI+EFV|Zidovudine + Didanosine+Efavirenz
1185394|NCT00342355|P4|Participant Flow|d4T + 3TC + r/LPV|Stavudine + Lamivudine + lopinavir/ritonavir
1185395|NCT00342355|P3|Participant Flow|d4T + 3TC + EFV|Stavudine + Lamivudine + Efavirenz
1185396|NCT00342355|P2|Participant Flow|AZT + ddI + r/LPV|Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV]
1185397|NCT00342355|P1|Participant Flow|AZT+ddI+EFV|Zidovudine + Didanosine+Efavirenz
1185398|NCT00342355|O4|Outcome|d4T + 3TC + r/LPV|Stavudine + Lamivudine + lopinavir/ritonavir
1185399|NCT00342355|O3|Outcome|d4T + 3TC + EFV|Stavudine + Lamivudine + efavirenz
1185400|NCT00342355|O2|Outcome|AZT + ddI + r/LPV|Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV]
1185401|NCT00342355|O1|Outcome|AZT+ddI+EFV|Zidovudine + Didanosine+Efavirenz
1185402|NCT00342355|O4|Outcome|d4T + 3TC + r/LPV|Stavudine + Lamivudine + lopinavir/ritonavir
1185403|NCT00342355|O3|Outcome|d4T + 3TC + EFV|Stavudine + Lamivudine + efavirenz
1185404|NCT00342355|O2|Outcome|AZT + ddI + r/LPV|Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV]
1185405|NCT00342355|O1|Outcome|AZT+ddI+EFV|Zidovudine + Didanosine+Efavirenz
1185406|NCT00342355|E4|Reported Event|d4T + 3TC + r/LPV|Stavudine + Lamivudine + lopinavir/ritonavir
1185407|NCT00342355|E3|Reported Event|d4T + 3TC + EFV|Stavudine + Lamivudine + efavirenz
1185408|NCT00342355|E2|Reported Event|AZT + ddI + r/LPV|Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV]
1185409|NCT00342355|E1|Reported Event|AZT+ddI+EFV|Zidovudine + Didanosine+Efavirenz
1185410|NCT00340834|B6|Baseline|Total|Total of all reporting groups
1185411|NCT00340834|B5|Baseline|Interferon β-1a/Fingolimod 0.5 mg|Patients who received Interferon β-1a 30 µg in the core phase of the study were randomized to receive self-administered fingolimod 0.5 mg capsules orally once daily.
1185412|NCT00340834|B4|Baseline|Interferon β-1a/Fingolimod 1.25 mg|Patients who received Interferon β-1a 30 µg in the core phase of the study were randomized to receive self-administered fingolimod 1.25 mg capsules orally once daily.
1185413|NCT00340834|B3|Baseline|Interferon β-1a 30 µg|Patients self-administered interferon β-1a 30 μg in an intramuscular (im) injection once weekly. In addition, they self-administered a fingolimod placebo capsule orally once daily.
1185414|NCT00340834|B2|Baseline|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
1185415|NCT00340834|B1|Baseline|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
1185416|NCT00340834|P5|Participant Flow|Interferon β-1a/Fingolimod 0.5 mg|Patients who received Interferon β-1a 30 µg in the core phase of the study were randomized to receive self-administered fingolimod 0.5 mg capsules orally once daily.
1185417|NCT00340834|P4|Participant Flow|Interferon β-1a/Fingolimod 1.25 mg|Patients who received Interferon β-1a 30 µg in the core phase of the study were randomized to receive self-administered fingolimod 1.25 mg capsules orally once daily.
1185418|NCT00340834|P3|Participant Flow|Interferon β-1a 30 µg|Patients self-administered interferon β-1a 30 μg in an intramuscular (im) injection once weekly. In addition, they self-administered a fingolimod placebo capsule orally once daily.
1185419|NCT00340834|P2|Participant Flow|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
1185420|NCT00340834|P1|Participant Flow|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
1185421|NCT00340834|O3|Outcome|Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg|Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.
1185422|NCT00340834|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
1185423|NCT00340834|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
1185424|NCT00340834|O3|Outcome|Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg|Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.
1185425|NCT00340834|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
1185426|NCT00340834|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
1185427|NCT00340834|O3|Outcome|Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg|Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.
1185428|NCT00340834|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
1185429|NCT00340834|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
1185430|NCT00340834|O3|Outcome|Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg|Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.
1185431|NCT00340834|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
1185432|NCT00340834|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
1185433|NCT00340834|O3|Outcome|Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg|Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.
1185434|NCT00340834|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
1185435|NCT00340834|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
1185436|NCT00340834|O3|Outcome|Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg|Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.
1185437|NCT00340834|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
1185438|NCT00340834|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
1185439|NCT00340834|E5|Reported Event|EXT FTY720 0.5 mg|EXT FTY720 0.5 mg
1185440|NCT00340834|E4|Reported Event|EXT FTY720 1.25 mg|EXT FTY720 1.25 mg
1185441|NCT00340834|E3|Reported Event|COR Interferon Beta-1a|COR Interferon beta-1a
1185442|NCT00340834|E2|Reported Event|COR FTY720 0.5 mg|COR FTY720 0.5 mg
1185443|NCT00340834|E1|Reported Event|COR FTY720 1.25 mg|COR FTY720 1.25 mg
1185444|NCT00340704|B10|Baseline|Total|Total of all reporting groups
1185445|NCT00340704|B9|Baseline|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
1185446|NCT00340704|B8|Baseline|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
1185447|NCT00340704|B7|Baseline|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
1185448|NCT00340704|B6|Baseline|Tamsulosin - High Dose Level (Group D-Denovo)|Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
1185605|NCT00339183|O1|Outcome|Wild-type KRAS - Panitumumab Plus FOLFIRI|Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
1185606|NCT00339183|O4|Outcome|Mutant KRAS - FOLFIRI Alone|Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
1185607|NCT00339183|O3|Outcome|Mutant KRAS - Panitumumab Plus FOLFIRI|Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
1186050|NCT00337662|O2|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1185449|NCT00340704|B5|Baseline|Tamsulosin - Medium Dose Level (Group D-Denovo)|Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
1185450|NCT00340704|B4|Baseline|Tamsulosin - Low Dose Level (Group D-Denovo)|Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
1185451|NCT00340704|B3|Baseline|Tamsulosin - High Dose Level (PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight. In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd,body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
1185452|NCT00340704|B2|Baseline|Tamsulosin - Medium Dose Level (PK Study)|Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
1185453|NCT00340704|B1|Baseline|Tamsulosin - Low Dose Level (PK Study)|Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
1185454|NCT00340704|P9|Participant Flow|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185455|NCT00340704|P8|Participant Flow|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185456|NCT00340704|P7|Participant Flow|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185603|NCT00339183|O3|Outcome|Mutant KRAS - Panitumumab Plus FOLFIRI|Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
1185457|NCT00340704|P6|Participant Flow|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1- 100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185458|NCT00340704|P5|Participant Flow|Tamsulosin - Medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185459|NCT00340704|P4|Participant Flow|Tamsulosin - Low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185460|NCT00340704|P3|Participant Flow|Tamsulosin - High Dose Level (PK Study)|"Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.~In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd,body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185461|NCT00340704|P2|Participant Flow|Tamsulosin - Medium Dose Level (PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185462|NCT00340704|P1|Participant Flow|Tamsulosin - Low Dose Level (PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185463|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185464|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
1185604|NCT00339183|O2|Outcome|Wild-type KRAS - FOLFIRI Alone|Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
1185465|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185466|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185467|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
1185468|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185469|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185470|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
1185471|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185472|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185821|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
1185473|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
1185474|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185475|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185476|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
1185477|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185478|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185479|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
1185480|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185481|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185482|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
1185483|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185484|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185485|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
1185486|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185487|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185488|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
1185489|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185490|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185491|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
1185492|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185493|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185494|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
1185495|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185496|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185822|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
1185497|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
1185498|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185499|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185500|NCT00340704|O1|Outcome|PK Study - Single Dose|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride once daily dependent on a subject's body weight (12.1 – 25.0 kg, 25.1 – 50.0 kg and 50.1 – 100.0 kg), by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.~In PK Single dose study, it was planned to obtain the Low dose PK data after single dose from all the 30 patients randomized to Low, Medium and high. However as per the protocol amendment, the PK sampling after first drug administration of low dose level was stopped after inclusion of 11 patients and therefore the PK sample of 11 patients were evaluated for PK single dose."
1185501|NCT00340704|O1|Outcome|PK Study - Single Dose|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride once daily dependent on a subject's body weight (12.1 – 25.0 kg, 25.1 – 50.0 kg and 50.1 – 100.0 kg), by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.~In PK Single dose study, it was planned to obtain the Low dose PK data after single dose from all the 30 patients randomized to Low, Medium and high. However as per the protocol amendment, the PK sampling after first drug administration of low dose level was stopped after inclusion of 11 patients and therefore the PK sample of 11 patients were evaluated for PK single dose."
1185502|NCT00340704|O1|Outcome|PK Study - Single Dose|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride once daily dependent on a subject's body weight (12.1 – 25.0 kg, 25.1 – 50.0 kg and 50.1 – 100.0 kg), by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.~In PK Single dose study, it was planned to obtain the Low dose PK data after single dose from all the 30 patients randomized to Low, Medium and high. However as per the protocol amendment, the PK sampling after first drug administration of low dose level was stopped after inclusion of 11 patients and therefore the PK sample of 11 patients were evaluated for PK single dose."
1185503|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185504|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185599|NCT00339183|P1|Participant Flow|Panitumumab Plus FOLFIRI|Participants were randomized to 6 mg/kg panitumumab intravenous infusion plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
1185600|NCT00339183|O2|Outcome|FOLFIRI Alone|Participants received FOLFIRI chemotherapy regimen administered in cycles every two weeks.
1185601|NCT00339183|O1|Outcome|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab IV plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
1185505|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185506|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185507|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185508|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185509|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185510|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185511|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185512|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1186339|NCT00336700|E1|Reported Event|Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)|
1185513|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185514|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185515|NCT00340704|O6|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185516|NCT00340704|O5|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185517|NCT00340704|O4|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185518|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185519|NCT00340704|O2|Outcome|Tamsulosin-medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185520|NCT00340704|O1|Outcome|Tamsulosin-low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185521|NCT00340704|O6|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185522|NCT00340704|O5|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185523|NCT00340704|O4|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185524|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185525|NCT00340704|O2|Outcome|Tamsulosin-medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185526|NCT00340704|O1|Outcome|Tamsulosin-low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185527|NCT00340704|O6|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185528|NCT00340704|O5|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185529|NCT00340704|O4|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185530|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185531|NCT00340704|O2|Outcome|Tamsulosin-medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185532|NCT00340704|O1|Outcome|Tamsulosin-low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185533|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185534|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185535|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185536|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1195569|NCT00313144|O2|Outcome|>6 Months to ≤12 Months|
1185537|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185538|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185539|NCT00340704|O6|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185540|NCT00340704|O5|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185541|NCT00340704|O4|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185542|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185543|NCT00340704|O2|Outcome|Tamsulosin-medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185544|NCT00340704|O1|Outcome|Tamsulosin-low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185545|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185546|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185547|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185548|NCT00340704|O6|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185549|NCT00340704|O5|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185550|NCT00340704|O4|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185551|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185552|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
1185553|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
1185554|NCT00340704|E9|Reported Event|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
1185555|NCT00340704|E8|Reported Event|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
1185556|NCT00340704|E7|Reported Event|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
1185557|NCT00340704|E6|Reported Event|Tamsulosin - High Dose Level (Group D-Denovo)|Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1- 100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
1185558|NCT00340704|E5|Reported Event|Tamsulosin - Medium Dose Level (Group D-Denovo)|Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
1185559|NCT00340704|E4|Reported Event|Tamsulosin - Low Dose Level (Group D-Denovo)|Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
1185560|NCT00340704|E3|Reported Event|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
1185602|NCT00339183|O4|Outcome|Mutant KRAS - FOLFIRI Alone|Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
1186046|NCT00337662|O2|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1185561|NCT00340704|E2|Reported Event|Tamsulosin - Medium Dose Level (Steady State - PK Study)|Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
1185562|NCT00340704|E1|Reported Event|Tamsulosin - Low Dose Level (Steady State - PK Study)|Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
1185563|NCT00340678|B5|Baseline|Total|Total of all reporting groups
1185564|NCT00340678|B4|Baseline|Microalbuminuria Placebo|Subjects with Microalbuminuria were treated with placebo corresponding to each dose of losartan.
1185565|NCT00340678|B3|Baseline|Microalbuminuria Losartan|Subjects with microalbuminuria were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
1185566|NCT00340678|B2|Baseline|Normoalbuminuria Placebo|Subjects with normal urinary albumin excretion were treated with placebo corresponding to each dose of losartan.
1185567|NCT00340678|B1|Baseline|Normoalbuminuria Losartan|Subjects with normal urinary albumin excretion were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
1185568|NCT00340678|P4|Participant Flow|Microalbuminuria Placebo|Subjects with Microalbuminuria were treated with placebo corresponding to each dose of losartan.
1185569|NCT00340678|P3|Participant Flow|Microalbuminuria Losartan|Subjects with microalbuminuria were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
1185570|NCT00340678|P2|Participant Flow|Normoalbuminuria Placebo|Subjects with normal urinary albumin excretion were treated with placebo corresponding to each dose of losartan.
1185571|NCT00340678|P1|Participant Flow|Normoalbuminuria Losartan|Subjects with normal urinary albumin excretion were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
1185572|NCT00340678|O4|Outcome|Microalbuminuria Placebo|Subjects with Microalbuminuria were treated with placebo corresponding to each dose of losartan.
1185573|NCT00340678|O3|Outcome|Microalbuminuria Losartan|Subjects with microalbuminuria were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
1185574|NCT00340678|O2|Outcome|Normoalbuminuria Placebo|Subjects with normal urinary albumin excretion were treated with placebo corresponding to each dose of losartan.
1185575|NCT00340678|O1|Outcome|Normoalbuminuria Losartan|Subjects with normal urinary albumin excretion were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
1185576|NCT00340678|O4|Outcome|Microalbuminuria Placebo|Subjects with Microalbuminuria were treated with placebo corresponding to each dose of losartan.
1185577|NCT00340678|O3|Outcome|Microalbuminuria Losartan|Subjects with microalbuminuria were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
1185578|NCT00340678|O2|Outcome|Normoalbuminuria Placebo|Subjects with normal urinary albumin excretion were treated with placebo corresponding to each dose of losartan.
1185579|NCT00340678|O1|Outcome|Normoalbuminuria Losartan|Subjects with normal urinary albumin excretion were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
1185580|NCT00340678|E2|Reported Event|Placebo|Subjects received placebo
1185581|NCT00340678|E1|Reported Event|Losartan|Subjects received losartan
1185582|NCT00340379|B3|Baseline|Total|Total of all reporting groups
1185583|NCT00340379|B2|Baseline|Sertraline/Haloperidol|
1185584|NCT00340379|B1|Baseline|Ziprasidone|
1185585|NCT00340379|P2|Participant Flow|Sertraline/Haloperidol|Target dosage of 150-200mg/day for sertraline and 6-8mg/day for haloperidol.
1185586|NCT00340379|P1|Participant Flow|Ziprasidone|Target dosage of 120-160mg/day based on tolerance.
1185587|NCT00340379|O2|Outcome|Sertraline/Haloperidol|
1185588|NCT00340379|O1|Outcome|Ziprasidone|
1185589|NCT00340379|O2|Outcome|Sertraline/Haloperidol|
1185590|NCT00340379|O1|Outcome|Ziprasidone|
1185591|NCT00340379|O2|Outcome|Sertraline/Haloperidol|
1185592|NCT00340379|O1|Outcome|Ziprasidone|
1185593|NCT00340379|E2|Reported Event|Sertraline/Haloperidol|
1185594|NCT00340379|E1|Reported Event|Ziprasidone|
1185595|NCT00339183|B3|Baseline|Total|Total of all reporting groups
1185596|NCT00339183|B2|Baseline|FOLFIRI Alone|Participants were randomized to receive a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
1185597|NCT00339183|B1|Baseline|Panitumumab Plus FOLFIRI|Participants were randomized to 6 mg/kg panitumumab intravenous infusion plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
1185598|NCT00339183|P2|Participant Flow|FOLFIRI Alone|Participants were randomized to receive a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
1186098|NCT00337571|O1|Outcome|Placebo|
1185608|NCT00339183|O2|Outcome|Wild-type KRAS - FOLFIRI Alone|Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
1185609|NCT00339183|O1|Outcome|Wild-type KRAS - Panitumumab Plus FOLFIRI|Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
1185610|NCT00339183|O4|Outcome|Mutant KRAS - FOLFIRI Alone|Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
1185611|NCT00339183|O3|Outcome|Mutant KRAS - Panitumumab Plus FOLFIRI|Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
1185612|NCT00339183|O2|Outcome|Wild-type KRAS - FOLFIRI Alone|Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
1185613|NCT00339183|O1|Outcome|Wild-type KRAS - Panitumumab Plus FOLFIRI|Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
1185614|NCT00339183|O4|Outcome|Mutant KRAS - FOLFIRI Alone|Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
1185615|NCT00339183|O3|Outcome|Mutant KRAS - Panitumumab Plus FOLFIRI|Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
1185616|NCT00339183|O2|Outcome|Wild-type KRAS - FOLFIRI Alone|Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
1185617|NCT00339183|O1|Outcome|Wild-type KRAS - Panitumumab Plus FOLFIRI|Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
1185618|NCT00339183|O4|Outcome|Mutant KRAS - FOLFIRI Alone|Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
1185619|NCT00339183|O3|Outcome|Mutant KRAS - Panitumumab Plus FOLFIRI|Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
1185620|NCT00339183|O2|Outcome|Wild-type KRAS - FOLFIRI Alone|Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
1185621|NCT00339183|O1|Outcome|Wild-type KRAS - Panitumumab Plus FOLFIRI|Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
1185622|NCT00339183|E2|Reported Event|FOLFIRI Alone|Participants received FOLFIRI chemotherapy regimen administered in cycles every two weeks.
1185623|NCT00339183|E1|Reported Event|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab IV plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
1185624|NCT00339144|B4|Baseline|Total|Total of all reporting groups
1185625|NCT00339144|B3|Baseline|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
1185626|NCT00339144|B2|Baseline|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185627|NCT00339144|B1|Baseline|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185628|NCT00339144|P3|Participant Flow|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
1185629|NCT00339144|P2|Participant Flow|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185729|NCT00339079|P2|Participant Flow|Placebo|Patients only received placebo pills accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office
1185730|NCT00339079|P1|Participant Flow|Cognitive Behavioral Therapy (CBT)|Patients in this arm only received Cognitive Behavioral Therapy (CBT). Six, 60 minute weekly sessions were followed by 4 bi-weekly sessions and 3 monthly booster sessions.
1185630|NCT00339144|P1|Participant Flow|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185631|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
1185632|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185633|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185634|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
1185635|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185636|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185637|NCT00339144|O1|Outcome|Dasatinib (Total)|Dasatinib(100 mg, 150 mg, 200 mg) was administered once daily via oral route for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose would be escalated to next higher level. If a DLT was observed among one of three treated participants in the first course at a dose level, 3 participants would be additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose might be escalated to next higher dose level.
1185638|NCT00339144|O1|Outcome|Dasatinib (Total)|Dasatinib(100 mg, 150 mg, 200 mg) was administered once daily via oral route for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose would be escalated to next higher level. If a DLT was observed among one of three treated participants in the first course at a dose level, 3 participants would be additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose might be escalated to next higher dose level.
1185639|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
1185640|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185641|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185642|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
1185643|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185644|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185645|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
1185646|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185647|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185648|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
1185649|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185650|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185651|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
1185652|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185653|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185654|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
1185745|NCT00339040|B1|Baseline|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
1185746|NCT00339040|P2|Participant Flow|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
1186099|NCT00337571|O4|Outcome|Aripiprazole 15 mg|
1185655|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185656|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185657|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
1185658|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185659|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185660|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
1185661|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185662|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185663|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
1185664|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185665|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185666|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
1185747|NCT00339040|P1|Participant Flow|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
1185748|NCT00339040|O2|Outcome|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
1186100|NCT00337571|O3|Outcome|Aripiprazole 10 mg|
1185667|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185668|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185669|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
1185670|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185671|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185672|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
1185673|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185674|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185675|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
1185676|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185677|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185678|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
1185749|NCT00339040|O1|Outcome|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
1185750|NCT00339040|O2|Outcome|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
1186101|NCT00337571|O2|Outcome|Aripiprazole 5 mg|
1185679|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185680|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185681|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
1185682|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185683|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185684|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
1185685|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185686|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185687|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
1185688|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185689|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185690|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
1185751|NCT00339040|O1|Outcome|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
1185752|NCT00339040|O2|Outcome|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
1186102|NCT00337571|O1|Outcome|Placebo|
1185691|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185692|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185693|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
1185694|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185695|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185696|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
1185697|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185698|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185699|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
1185700|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185701|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185702|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
1185753|NCT00339040|O1|Outcome|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
1185754|NCT00339040|O2|Outcome|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
1186103|NCT00337571|O4|Outcome|Aripiprazole 15 mg|
1185703|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185704|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185705|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
1185706|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185707|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185708|NCT00339144|E3|Reported Event|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
1185709|NCT00339144|E2|Reported Event|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185710|NCT00339144|E1|Reported Event|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
1185711|NCT00339833|B3|Baseline|Total|Total of all reporting groups
1185712|NCT00339833|B2|Baseline|Placebo|Identical placebo for 7 days
1185713|NCT00339833|B1|Baseline|Salsalate|Salsalate (3g/day) for 7 days
1185714|NCT00339833|P2|Participant Flow|Placebo|Placebo for 7 days.
1185715|NCT00339833|P1|Participant Flow|Salsalate|The intervention was salsalate (3g/day) for 7 days
1185716|NCT00339833|O2|Outcome|Placebo|Identical placebo for 7 days
1185717|NCT00339833|O1|Outcome|Salsalate|Salsalate (3g/day) for 7 days
1185718|NCT00339833|O2|Outcome|Placebo|Identical placebo for 7 days
1185719|NCT00339833|O1|Outcome|Salsalate|Salsalate (3g/day) for 7 days
1185720|NCT00339833|E2|Reported Event|Placebo|Identical placebo for 7 days
1185721|NCT00339833|E1|Reported Event|Salsalate|Salsalate (3g/day) for 7 days
1185722|NCT00339079|B5|Baseline|Total|Total of all reporting groups
1185723|NCT00339079|B4|Baseline|Combined CBT and Fluoxetine|Patients in this arm received both CBT and the fluoxetine medication. Both interventions were administered in the same way as when administered alone in the other arms.
1185724|NCT00339079|B3|Baseline|Fluoxetine|Patients only received the SSRI Fluoxetine. Medication was adminstered on a fixed-flexible dosing regimen, beginning at 10mg/day for 2 weeks, then 20 mg/day for 2 weeks, 40 mg/day for two weeks, 60 mg/day for 2 weeks, and 80 mg/day (the target dose) thereafter.
1185725|NCT00339079|B2|Baseline|Placebo|Patients only received placebo pills
1185726|NCT00339079|B1|Baseline|Cognitive Behavioral Therapy (CBT)|Patients in this arm only received Cognitive Behavioral Therapy (CBT). Six, 60 minute weekly sessions were followed by 4 bi-weekly sessions and 3 monthly booster sessions.
1185727|NCT00339079|P4|Participant Flow|Combined CBT and Fluoxetine|Patients in this arm received both CBT and the fluoxetine medication. Both interventions were administered in the same way as when adminstered alone in the other arms.
1185728|NCT00339079|P3|Participant Flow|Fluoxetine|Patients only received the SSRI Fluoxetine. Medication was adminstered on a fixed-flexible dosing regimen, beginning at 10mg/day for 2 weeks, then 20 mg/day for 2 weeks, 40 mg/day for two weeks, 60 mg/day for 2 weeks, and 80 mg/day (the target dose) thereafter. This was accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office.
1185755|NCT00339040|O1|Outcome|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
1185756|NCT00339040|O2|Outcome|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
1185825|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
1185731|NCT00339079|O4|Outcome|Combined CBT and Fluoxetine|"Patients arm received both CBT and the fluoxetine medication. Both interventions were administered in the same way as when adminstered alone in the other arms.~Fluoxetine: Each patient will receive fluoxetine in 10 or 20 mg pills given according to the following schedule: 10 mg/day for two weeks, 20 mg/day for two weeks, 40 mg/day for two weeks, 60 mg/day for two weeks, and 80 mg/day thereafter. The maximum dose for patients who are age 60 or older will be 60 mg/day. The study psychiatrist will have the option of not increasing or lowering the dose if hypochondriacal symptoms have resolved nearly completely for the last two weeks or adverse effects thought to be due to fluoxetine have occurred.~Cognitive Behavioral Therapy (CBT): CBT is based upon the cognitive and perceptual model of hypochondriasis and incorporates established behavioral techniques. There will be six 60-minute individual sessions conducted at weekly intervals. Booster sessions of 20 to 30 minutes wi"
1185732|NCT00339079|O3|Outcome|Fluoxetine|"Patients received the SSRI Fluoxetine. Medication was adminstered on a fixed-flexible dosing regimen, beginning at 10mg/day for 2 weeks, then 20 mg/day for 2 weeks, 40 mg/day for two weeks, 60 mg/day for 2 weeks, and 80 mg/day (the target dose) thereafter. This was accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office.~Fluoxetine: Each patient will receive fluoxetine in 10 or 20 mg pills given according to the following schedule: 10 mg/day for two weeks, 20 mg/day for two weeks, 40 mg/day for two weeks, 60 mg/day for two weeks, and 80 mg/day thereafter. The maximum dose for patients who are age 60 or older will be 60 mg/day. The study psychiatrist will have the option of not increasing or lowering the dose if hypochondriacal symptoms have resolved nearly completely for the last two weeks or adverse effects thought to be due to fluoxetine have occurred.~Supportiv"
1185733|NCT00339079|O2|Outcome|Placebo|"Patients only received placebo pills accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office.~Supportive Therapy: The supportive therapy component of the treatment is similar to what might occur in a family physician's office. Participants will meet with the same psychiatrist throughout the study, who will offer general encouragement; review the participant's illness, physical symptoms and, adverse effects over the previous week; and monitor medication dosage accordingly. Patients will be seen at Weeks 1, 2, 3, 4, 6, 8, 10, and 12, for medication adjustment. Visits with the psychiatrist will last 30 minutes.~Placebo: Each patient will receive placebo in 10 or 20 mg pills given according to the following schedule: 10 mg/day for two weeks, 20 mg/day for two weeks, 40 mg/day for two weeks, 60 mg/day for two weeks, and 80 mg/day thereafter."
1185734|NCT00339079|O1|Outcome|Cognitive Behavioral Therapy (CBT)|"Patients in this arm only received Cognitive Behavioral Therapy (CBT). Six, 60 minute weekly sessions were followed by 4 bi-weekly sessions and 3 monthly booster sessions.~Cognitive Behavioral Therapy (CBT): CBT is based upon the cognitive and perceptual model of hypochondriasis and incorporates established behavioral techniques. There will be six 60-minute individual sessions conducted at weekly intervals. Booster sessions of 20 to 30 minutes will be conducted at Weeks 8 and 12. The introduction of boosters will make the CBT alone and medication alone arms identical in length."
1185735|NCT00339079|O4|Outcome|Combined CBT and Fluoxetine|Patients in this arm received both CBT and the fluoxetine medication. Both interventions were administered in the same way as when adminstered alone in the other arms.
1185736|NCT00339079|O3|Outcome|Fluoxetine|Patients only received the SSRI Fluoxetine. Medication was adminstered on a fixed-flexible dosing regimen, beginning at 10mg/day for 2 weeks, then 20 mg/day for 2 weeks, 40 mg/day for two weeks, 60 mg/day for 2 weeks, and 80 mg/day (the target dose) thereafter. This was accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office.
1185737|NCT00339079|O2|Outcome|Placebo|Patients only received placebo pills accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office
1185738|NCT00339079|O1|Outcome|Cognitive Behavioral Therapy (CBT)|Patients in this arm only received Cognitive Behavioral Therapy (CBT). Six, 60 minute weekly sessions were followed by 4 bi-weekly sessions and 3 monthly booster sessions.
1185739|NCT00339079|E4|Reported Event|Combined CBT and Fluoxetine|Patients in this arm received both CBT and the fluoxetine medication. Both interventions were administered in the same way as when adminstered alone in the other arms.
1185740|NCT00339079|E3|Reported Event|Fluoxetine|Patients only received the SSRI Fluoxetine. Medication was adminstered on a fixed-flexible dosing regimen, beginning at 10mg/day for 2 weeks, then 20 mg/day for 2 weeks, 40 mg/day for two weeks, 60 mg/day for 2 weeks, and 80 mg/day (the target dose) thereafter. This was accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office.
1185741|NCT00339079|E2|Reported Event|Placebo|"Patients only received placebo pills accompanied by medication management supportive therapy; including non-specific encouragement, support and explanation similar to that provide in a physician's office.~Supportive Therapy: The supportive therapy component of the treatment is similar to what might occur in a family physician's office. Participants will meet with the same psychiatrist throughout the study, who will offer general encouragement; review the participant's illness, physical symptoms and, adverse effects over the previous week; and monitor medication dosage accordingly. Patients will be seen at Weeks 1, 2, 3, 4, 6, 8, 10, and 12, for medication adjustment. Visits with the psychiatrist will last 30 minutes.~Placebo: Each patient will receive placebo in 10 or 20 mg pills given according to the following schedule: 10 mg/day for two weeks, 20 mg/day for two weeks, 40 mg/day for two weeks, 60 mg/day for two weeks, and 80 mg/day thereafter."
1185742|NCT00339079|E1|Reported Event|Cognitive Behavioral Therapy (CBT)|"Patients in this arm only received Cognitive Behavioral Therapy (CBT). Six, 60 minute weekly sessions were followed by 4 bi-weekly sessions and 3 monthly booster sessions.~Cognitive Behavioral Therapy (CBT): CBT is based upon the cognitive and perceptual model of hypochondriasis and incorporates established behavioral techniques. There will be six 60-minute individual sessions conducted at weekly intervals. Booster sessions of 20 to 30 minutes will be conducted at Weeks 8 and 12. The introduction of boosters will make the CBT alone and medication alone arms identical in length."
1185743|NCT00339040|B3|Baseline|Total|Total of all reporting groups
1185744|NCT00339040|B2|Baseline|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
1186104|NCT00337571|O3|Outcome|Aripiprazole 10 mg|
1185757|NCT00339040|O1|Outcome|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
1185758|NCT00339040|O2|Outcome|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
1185759|NCT00339040|O1|Outcome|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
1185760|NCT00339040|O2|Outcome|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
1185761|NCT00339040|O1|Outcome|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
1185762|NCT00339040|E2|Reported Event|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
1185763|NCT00339040|E1|Reported Event|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
1185764|NCT00338988|B1|Baseline|Capecitabine + Oxaliplatin|Combination of intravenous (IV) oxaliplatin 100 mg/m^2 Day 1 and oral capecitabine 750 mg/m^2 twice daily on Days 1-14.
1185765|NCT00338988|P1|Participant Flow|Capecitabine + Oxaliplatin|Combination of intravenous (IV) oxaliplatin 100 mg/m^2 Day 1 and oral capecitabine 750 mg/m^2 twice daily on Days 1-14.
1185766|NCT00338988|O1|Outcome|Capecitabine + Oxaliplatin|Combination of intravenous (IV) oxaliplatin 100 mg/m^2 Day 1 and oral capecitabine 750 mg/m^2 twice daily on Days 1-14.
1185767|NCT00338988|E2|Reported Event|Stratum 2: No Prior Therapy|Previously untreated. Capecitabine + Oxaliplatin: Experimental. Combination of IV oxaliplatin 100 mg/m^2 Day 1 and oral capecitabine 750 mg/m^2 twice daily on Day 1-14.
1185768|NCT00338988|E1|Reported Event|Stratum: 1 Prior Regimen|Received prior therapy. Capecitabine + Oxaliplatin: Experimental. Combination of IV oxaliplatin 100 mg/m^2 Day 1 and oral capecitabine 750 mg/m^2 twice daily on Day 1-14.
1185769|NCT00338962|B5|Baseline|Total|Total of all reporting groups
1185770|NCT00338962|B4|Baseline|Desipramine and Placebo|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.~desipramine: 200 mg per day~Placebo: placebo"
1185771|NCT00338962|B3|Baseline|Desipramine and Naltrexone|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~desipramine: 200 mg per day~Naltrexone: 50 mg per day"
1185772|NCT00338962|B2|Baseline|Paroxetine and Placebo|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.~paroxetine: paroxetine (40mg/day)~Placebo: placebo"
1185773|NCT00338962|B1|Baseline|Paroxetine and Naltrexone|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~paroxetine: paroxetine (40mg/day)~Naltrexone: 50 mg per day"
1185774|NCT00338962|P4|Participant Flow|Desipramine and Placebo|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.~desipramine: 200 mg per day~Placebo: placebo"
1185775|NCT00338962|P3|Participant Flow|Desipramine and Naltrexone|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~desipramine: 200 mg per day~Naltrexone: 50 mg per day"
1185776|NCT00338962|P2|Participant Flow|Paroxetine and Placebo|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.~paroxetine: paroxetine (40mg/day)~Placebo: placebo"
1185777|NCT00338962|P1|Participant Flow|Paroxetine and Naltrexone|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~paroxetine: paroxetine (40mg/day)~Naltrexone: 50 mg per day"
1185778|NCT00338962|O4|Outcome|Desipramine and Placebo|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.~desipramine: 200 mg per day~Placebo: placebo"
1185779|NCT00338962|O3|Outcome|Desipramine and Naltrexone|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~desipramine: 200 mg per day~Naltrexone: 50 mg per day"
1185780|NCT00338962|O2|Outcome|Paroxetine and Placebo|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.~paroxetine: paroxetine (40mg/day)~Placebo: placebo"
1185781|NCT00338962|O1|Outcome|Paroxetine and Naltrexone|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~paroxetine: paroxetine (40mg/day)~Naltrexone: 50 mg per day"
1185782|NCT00338962|O4|Outcome|Desipramine and Placebo|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.~desipramine: 200 mg per day~Placebo: placebo"
1185783|NCT00338962|O3|Outcome|Desipramine and Naltrexone|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~desipramine: 200 mg per day~Naltrexone: 50 mg per day"
1185784|NCT00338962|O2|Outcome|Paroxetine and Placebo|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.~paroxetine: paroxetine (40mg/day)~Placebo: placebo"
1185785|NCT00338962|O1|Outcome|Paroxetine and Naltrexone|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~paroxetine: paroxetine (40mg/day)~Naltrexone: 50 mg per day"
1185824|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
1185786|NCT00338962|O4|Outcome|Desipramine and Placebo|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.~desipramine: 200 mg per day~Placebo: placebo"
1185787|NCT00338962|O3|Outcome|Desipramine and Naltrexone|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~desipramine: 200 mg per day~Naltrexone: 50 mg per day"
1185788|NCT00338962|O2|Outcome|Paroxetine and Placebo|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.~paroxetine: paroxetine (40mg/day)~Placebo: placebo"
1185789|NCT00338962|O1|Outcome|Paroxetine and Naltrexone|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~paroxetine: paroxetine (40mg/day)~Naltrexone: 50 mg per day"
1185790|NCT00338962|O4|Outcome|Desipramine and Placebo|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.~desipramine: 200 mg per day~Placebo: placebo"
1185791|NCT00338962|O3|Outcome|Desipramine and Naltrexone|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~desipramine: 200 mg per day~Naltrexone: 50 mg per day"
1185792|NCT00338962|O2|Outcome|Paroxetine and Placebo|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.~paroxetine: paroxetine (40mg/day)~Placebo: placebo"
1185793|NCT00338962|O1|Outcome|Paroxetine and Naltrexone|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~paroxetine: paroxetine (40mg/day)~Naltrexone: 50 mg per day"
1185794|NCT00338962|E4|Reported Event|Desipramine and Placebo|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.~desipramine: 200 mg per day~Placebo: placebo"
1185795|NCT00338962|E3|Reported Event|Desipramine and Naltrexone|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~desipramine: 200 mg per day~Naltrexone: 50 mg per day"
1185796|NCT00338962|E2|Reported Event|Paroxetine and Placebo|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.~paroxetine: paroxetine (40mg/day)~Placebo: placebo"
1185797|NCT00338962|E1|Reported Event|Paroxetine and Naltrexone|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~paroxetine: paroxetine (40mg/day)~Naltrexone: 50 mg per day"
1185798|NCT00338884|B1|Baseline|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
1185799|NCT00338884|P1|Participant Flow|Sunitinib|37.5 milligrams (mg) oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
1185800|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
1185801|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
1185802|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
1185803|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
1185804|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
1185805|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
1185806|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
1185807|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
1185808|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
1185809|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
1185810|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
1185811|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
1185812|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
1185813|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
1185814|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
1185815|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
1185816|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
1185817|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
1185818|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
1185819|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
1185820|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
1185823|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
1186559|NCT00335504|B4|Baseline|Arm IV (Placebo)|Patients receive an oral placebo (maltodextrin powder) twice daily.
1185826|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
1185827|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
1185828|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
1185829|NCT00338884|E1|Reported Event|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
1185830|NCT00338741|B3|Baseline|Total|Total of all reporting groups
1185831|NCT00338741|B2|Baseline|Non-Rebif Exposed Pregnancies|Women with MS who had not received any IFN-beta therapy during pregnancy or within 90 days of conception
1185832|NCT00338741|B1|Baseline|Rebif Exposed Pregnancies|Women with multiple sclerosis (MS) who were exposed to Rebif (interferon-beta [IFN-beta]-1a) during pregnancy or within one week of conception
1185833|NCT00338741|P2|Participant Flow|Non-Rebif Exposed Pregnancies|Women with MS who had not received any IFN-beta therapy during pregnancy or within 90 days of conception
1185834|NCT00338741|P1|Participant Flow|Rebif Exposed Pregnancies|Women with multiple sclerosis (MS) who were exposed to Rebif (interferon-beta [IFN-beta]-1a) during pregnancy or within one week of conception
1185835|NCT00338741|O2|Outcome|Non-Rebif Exposed Pregnancies|Women with MS who had not received any IFN-beta therapy during pregnancy or within 90 days of conception
1185836|NCT00338741|O1|Outcome|Rebif Exposed Pregnancies|Women with multiple sclerosis (MS) who were exposed to Rebif (interferon-beta [IFN-beta]-1a) during pregnancy or within one week of conception
1185837|NCT00338741|O2|Outcome|Non-Rebif Exposed Pregnancies|Women with MS who had not received any IFN-beta therapy during pregnancy or within 90 days of conception
1185838|NCT00338741|O1|Outcome|Rebif Exposed Pregnancies|Women with multiple sclerosis (MS) who were exposed to Rebif (interferon-beta [IFN-beta]-1a) during pregnancy or within one week of conception
1185839|NCT00338741|E2|Reported Event|Non-Rebif Exposed Pregnancies|Women with MS who had not received any IFN-beta therapy during pregnancy or within 90 days of conception
1185840|NCT00338741|E1|Reported Event|Rebif Exposed Pregnancies|Women with multiple sclerosis (MS) who were exposed to Rebif (interferon-beta [IFN-beta]-1a) during pregnancy or within one week of conception
1185841|NCT00338598|B3|Baseline|Total|Total of all reporting groups
1185842|NCT00338598|B2|Baseline|Placebo|"placebo will be administered.~placebo"
1185843|NCT00338598|B1|Baseline|Glycine|"Glycine, 0.8 gr per kg given in two daily doses~Glycine: Glycine, 0.8 gr per kg given in two daily doses"
1185844|NCT00338598|P2|Participant Flow|Placebo|"placebo will be administered.~placebo"
1185845|NCT00338598|P1|Participant Flow|Glycine|"Glycine, 0.8 gr per kg given in two daily doses~Glycine: Glycine, 0.8 gr per kg given in two daily doses"
1185846|NCT00338598|O2|Outcome|Placebo|"placebo will be administered.~placebo"
1185847|NCT00338598|O1|Outcome|Glycine|"Glycine, 0.8 gr per kg given in two daily doses~Glycine: Glycine, 0.8 gr per kg given in two daily doses"
1185848|NCT00338598|O2|Outcome|Placebo|"placebo will be administered.~placebo"
1185849|NCT00338598|O1|Outcome|Glycine|"Glycine, 0.8 gr per kg given in two daily doses~Glycine: Glycine, 0.8 gr per kg given in two daily doses"
1185850|NCT00338598|O2|Outcome|Placebo|"placebo will be administered.~placebo"
1185851|NCT00338598|O1|Outcome|Glycine|"Glycine, 0.8 gr per kg given in two daily doses~Glycine: Glycine, 0.8 gr per kg given in two daily doses"
1185852|NCT00338598|O2|Outcome|Placebo|"placebo will be administered.~placebo"
1185853|NCT00338598|O1|Outcome|Glycine|"Glycine, 0.8 gr per kg given in two daily doses~Glycine: Glycine, 0.8 gr per kg given in two daily doses"
1185854|NCT00338598|O2|Outcome|Placebo|"placebo will be administered.~placebo"
1185855|NCT00338598|O1|Outcome|Glycine|"Glycine, 0.8 gr per kg given in two daily doses~Glycine: Glycine, 0.8 gr per kg given in two daily doses"
1185856|NCT00338598|O2|Outcome|Placebo|"placebo will be administered.~placebo"
1185857|NCT00338598|O1|Outcome|Glycine|"Glycine, 0.8 gr per kg given in two daily doses~Glycine: Glycine, 0.8 gr per kg given in two daily doses"
1185858|NCT00338598|O2|Outcome|Placebo|"placebo will be administered.~placebo"
1185859|NCT00338598|O1|Outcome|Glycine|"Glycine, 0.8 gr per kg given in two daily doses~Glycine: Glycine, 0.8 gr per kg given in two daily doses"
1185860|NCT00338598|E2|Reported Event|Placebo|"placebo will be administered.~placebo"
1185861|NCT00338598|E1|Reported Event|Glycine|"Glycine, 0.8 gr per kg given in two daily doses~Glycine: Glycine, 0.8 gr per kg given in two daily doses"
1185862|NCT00338455|B3|Baseline|Total|Total of all reporting groups
1185863|NCT00338455|B2|Baseline|Placebo + Standard Care + Dobutamine or Milrinone|Placebo - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
1185864|NCT00338455|B1|Baseline|Natrecor (Nesiritide)+Standard Care+Dobutamine or Milrinone|Nesiritide - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
1185865|NCT00338455|P2|Participant Flow|Placebo + Standard Care + Dobutamine or Milrinone|Placebo - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
1185866|NCT00338455|P1|Participant Flow|Natrecor (Nesiritide)+Standard Care+Dobutamine or Milrinone|Nesiritide - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
1185867|NCT00338455|O2|Outcome|Placebo + Standard Care + Dobutamine or Milrinone|Placebo - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
1185868|NCT00338455|O1|Outcome|Natrecor (Nesiritide)+Standard Care+Dobutamine or Milrinone|Nesiritide - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
1185869|NCT00338455|O2|Outcome|Placebo + Standard Care + Dobutamine or Milrinone|Placebo - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
1185870|NCT00338455|O1|Outcome|Natrecor (Nesiritide)+Standard Care+Dobutamine or Milrinone|Nesiritide - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
1185871|NCT00338455|O2|Outcome|Placebo + Standard Care + Dobutamine or Milrinone|Placebo - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
1199137|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
1185872|NCT00338455|O1|Outcome|Natrecor (Nesiritide)+Standard Care+Dobutamine or Milrinone|Nesiritide - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
1185873|NCT00338455|O2|Outcome|Placebo + Standard Care + Dobutamine or Milrinone|Placebo - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
1185874|NCT00338455|O1|Outcome|Natrecor (Nesiritide)+Standard Care+Dobutamine or Milrinone|Nesiritide - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
1185875|NCT00338455|E2|Reported Event|Placebo + Standard Care + Dobutamine or Milrinone|Placebo - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
1185876|NCT00338455|E1|Reported Event|Natrecor (Nesiritide)+Standard Care+Dobutamine or Milrinone|Nesiritide - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
1185877|NCT00338286|B3|Baseline|Total|Total of all reporting groups
1185878|NCT00338286|B2|Baseline|Epoetin Alfa|Participants recived SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
1185879|NCT00338286|B1|Baseline|Standard of Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.
1185880|NCT00338286|P2|Participant Flow|Epoetin Alfa|Participants recived SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
1185881|NCT00338286|P1|Participant Flow|Standard of Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.
1185882|NCT00338286|O2|Outcome|Epoetin Alfa|Participants recived SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
1185883|NCT00338286|O1|Outcome|Standard of Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.
1185884|NCT00338286|O2|Outcome|Epoetin Alfa|Participants recived SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
1185885|NCT00338286|O1|Outcome|Standard of Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.
1185886|NCT00338286|O2|Outcome|Epoetin Alfa|Participants recived SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
1185887|NCT00338286|O1|Outcome|Standard of Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.
1185888|NCT00338286|O2|Outcome|Epoetin Alfa|Participants recived SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
1185889|NCT00338286|O1|Outcome|Standard of Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.
1185890|NCT00338286|O2|Outcome|Epoetin Alfa|Participants recived SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
1185891|NCT00338286|O1|Outcome|Standard of Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.
1185892|NCT00338286|E2|Reported Event|Epoetin Alfa|Participants recived SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
1185893|NCT00338286|E1|Reported Event|Standard of Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.
1185894|NCT00338104|B4|Baseline|Total|Total of all reporting groups
1185895|NCT00338104|B3|Baseline|80% Group|Glargine at 80% of insulin drip rate
1185896|NCT00338104|B2|Baseline|60% Group|Glargine at 60% of insulin drip rate
1185897|NCT00338104|B1|Baseline|40% Group|Glargine at 40% of insulin drip rate
1185898|NCT00338104|P3|Participant Flow|80% Group|Glargine at 80% of insulin drip rate
1185899|NCT00338104|P2|Participant Flow|60% Group|Glargine at 60% of insulin drip rate
1185900|NCT00338104|P1|Participant Flow|40% Group|Glargine at 40% of insulin drip rate
1185901|NCT00338104|O3|Outcome|80% Group|Glargine at 80% of insulin drip rate
1185902|NCT00338104|O2|Outcome|60% Group|Glargine at 60% of insulin drip rate
1185903|NCT00338104|O1|Outcome|40% Group|Glargine at 40% of insulin drip rate
1185904|NCT00338104|O3|Outcome|80% Group|Glargine at 80% of insulin drip rate
1185905|NCT00338104|O2|Outcome|60% Group|Glargine at 60% of insulin drip rate
1185906|NCT00338104|O1|Outcome|40% Group|Glargine at 40% of insulin drip rate
1185907|NCT00338104|O3|Outcome|80% Group|Glargine at 80% of insulin drip rate
1185908|NCT00338104|O2|Outcome|60% Group|Glargine at 60% of insulin drip rate
1185909|NCT00338104|O1|Outcome|40% Group|Glargine at 40% of insulin drip rate
1185910|NCT00338039|B1|Baseline|Chemotherapy + Chemoradation|Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.
1185911|NCT00338039|P1|Participant Flow|Chemotherapy + Chemoradation|Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m^2 intravenous (IV)/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Grey delivered in 28 fractions.
1185941|NCT00337818|O2|Outcome|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
1185942|NCT00337818|O1|Outcome|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
1185912|NCT00338039|O1|Outcome|Chemotherapy + Chemoradation|Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.
1185913|NCT00338039|O1|Outcome|Chemotherapy + Chemoradation|Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.
1185914|NCT00338039|E1|Reported Event|Chemotherapy + Chemoradation|Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.
1185915|NCT00337987|B1|Baseline|Denileukin Diftitox/CHOP Administration|Patients received six 21-day cycles of therapy, up to a maximum of 8 cycle. Each cycle comprised of denileukin diftitox plus CHOP (cyclophasphamide, doxorubicin, vincristine, prednisone)
1185916|NCT00337987|P1|Participant Flow|Denileukin Diftitox/CHOP Administration|Patients received six 21-day cycles of therapy, up to a maximum of 8 cycle. Each cycle comprised of denileukin diftitox plus CHOP (cyclophasphamide, doxorubicin, vincristine, prednisone)
1185917|NCT00337987|O1|Outcome|Denileukin Diftitox/CHOP Administration|Patients received six 21-day cycles of therapy, up to a maximum of 8 cycle. Each cycle comprised of denileukin diftitox plus CHOP (cyclophasphamide, doxorubicin, vincristine, prednisone)
1185918|NCT00337987|O1|Outcome|Denileukin Diftitox/CHOP Administration|Patients received six 21-day cycles of therapy, up to a maximum of 8 cycle. Each cycle comprised of denileukin diftitox plus CHOP (cyclophasphamide, doxorubicin, vincristine, prednisone)
1185919|NCT00337987|E1|Reported Event|Denileukin Diftitox/CHOP Administration|Patients received six 21-day cycles of therapy, up to a maximum of 8 cycle. Each cycle comprised of denileukin diftitox plus CHOP (cyclophasphamide, doxorubicin, vincristine, prednisone)
1185920|NCT00337935|B3|Baseline|Total|Total of all reporting groups
1185921|NCT00337935|B2|Baseline|PROCRIT (Epoetin Alfa)|epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
1185922|NCT00337935|B1|Baseline|Standard of Care|Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).
1185923|NCT00337935|P2|Participant Flow|PROCRIT (Epoetin Alfa)|epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
1185924|NCT00337935|P1|Participant Flow|Standard of Care|Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).
1185925|NCT00337935|O2|Outcome|PROCRIT (Epoetin Alfa)|epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
1185926|NCT00337935|O1|Outcome|Standard of Care|Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs). Upper 95% confidence limit for the Standard of Care Group was not estimable because an insufficient number of participates reached the event at the final time point for assessment.
1185927|NCT00337935|O2|Outcome|PROCRIT (Epoetin Alfa)|epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
1185928|NCT00337935|O1|Outcome|Standard of Care|Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).
1185929|NCT00337935|O2|Outcome|PROCRIT (Epoetin Alfa)|epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
1185930|NCT00337935|O1|Outcome|Standard of Care|Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).
1185931|NCT00337935|E2|Reported Event|PROCRIT (Epoetin Alfa)|epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
1185932|NCT00337935|E1|Reported Event|Standard of Care|Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).
1185933|NCT00337818|B4|Baseline|Total|Total of all reporting groups
1185934|NCT00337818|B3|Baseline|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
1185935|NCT00337818|B2|Baseline|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
1185936|NCT00337818|B1|Baseline|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
1185937|NCT00337818|P3|Participant Flow|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
1185938|NCT00337818|P2|Participant Flow|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
1185939|NCT00337818|P1|Participant Flow|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
1185940|NCT00337818|O3|Outcome|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
1186105|NCT00337571|O2|Outcome|Aripiprazole 5 mg|
1186106|NCT00337571|O1|Outcome|Placebo|
1185943|NCT00337818|O3|Outcome|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
1185944|NCT00337818|O2|Outcome|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
1185945|NCT00337818|O1|Outcome|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
1185946|NCT00337818|O3|Outcome|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
1185947|NCT00337818|O2|Outcome|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
1185948|NCT00337818|O1|Outcome|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
1185949|NCT00337818|O3|Outcome|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
1185950|NCT00337818|O2|Outcome|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
1185951|NCT00337818|O1|Outcome|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
1185952|NCT00337818|O3|Outcome|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
1185953|NCT00337818|O2|Outcome|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
1185954|NCT00337818|O1|Outcome|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
1185955|NCT00337818|E3|Reported Event|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
1185956|NCT00337818|E2|Reported Event|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
1185957|NCT00337818|E1|Reported Event|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
1185958|NCT00337779|B3|Baseline|Total|Total of all reporting groups
1185959|NCT00337779|B2|Baseline|Glatiramer Acetate 40 mg|
1185960|NCT00337779|B1|Baseline|Glatiramer Acetate 20 mg|
1185961|NCT00337779|P2|Participant Flow|Glatiramer Acetate 40 mg|
1185962|NCT00337779|P1|Participant Flow|Glatiramer Acetate 20 mg|
1185963|NCT00337779|O2|Outcome|Glatiramer Acetate 40 mg|
1185964|NCT00337779|O1|Outcome|Glatiramer Acetate 20 mg|
1185965|NCT00337779|O2|Outcome|Glatiramer Acetate 40 mg|
1185966|NCT00337779|O1|Outcome|Glatiramer Acetate 20 mg|
1185967|NCT00337779|O2|Outcome|Glatiramer Acetate 40 mg|
1185968|NCT00337779|O1|Outcome|Glatiramer Acetate 20 mg|
1185969|NCT00337779|E2|Reported Event|Glatiramer Acetate 40 mg|
1185970|NCT00337779|E1|Reported Event|Glatiramer Acetate 20 mg|
1185971|NCT00337727|B3|Baseline|Total|Total of all reporting groups
1185972|NCT00337727|B2|Baseline|Standard Regimen|Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3.
1185973|NCT00337727|B1|Baseline|Aprepitant Regimen|Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3.
1185974|NCT00337727|P2|Participant Flow|Standard Regimen|Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3.
1185975|NCT00337727|P1|Participant Flow|Aprepitant Regimen|Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3.
1185976|NCT00337727|O2|Outcome|Standard Regimen|Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3.
1185977|NCT00337727|O1|Outcome|Aprepitant Regimen|Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3.
1185978|NCT00337727|O2|Outcome|Standard Regimen|Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3.
1185979|NCT00337727|O1|Outcome|Aprepitant Regimen|Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3.
1185980|NCT00337727|E2|Reported Event|Standard Regimen|Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3.
1185981|NCT00337727|E1|Reported Event|Aprepitant Regimen|Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3.
1185982|NCT00337675|B4|Baseline|Total|Total of all reporting groups
1186043|NCT00337662|O1|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186107|NCT00337571|O4|Outcome|Aripiprazole 15 mg|
1185983|NCT00337675|B3|Baseline|Placebo|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
1185984|NCT00337675|B2|Baseline|Intermittent Montelukast|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
1185985|NCT00337675|B1|Baseline|Daily Montelukast|Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
1185986|NCT00337675|P3|Participant Flow|Placebo|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
1185987|NCT00337675|P2|Participant Flow|Intermittent Montelukast|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
1185988|NCT00337675|P1|Participant Flow|Daily Montelukast|Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
1185989|NCT00337675|O3|Outcome|Placebo|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
1185990|NCT00337675|O2|Outcome|Intermittent Montelukast|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
1185991|NCT00337675|O1|Outcome|Daily Montelukast|Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
1185992|NCT00337675|O3|Outcome|Placebo|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
1185993|NCT00337675|O2|Outcome|Intermittent Montelukast|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
1185994|NCT00337675|O1|Outcome|Daily Montelukast|Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
1185995|NCT00337675|O3|Outcome|Placebo|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
1185996|NCT00337675|O2|Outcome|Intermittent Montelukast|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
1185997|NCT00337675|O1|Outcome|Daily Montelukast|Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
1185998|NCT00337675|E3|Reported Event|Placebo|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
1186044|NCT00337662|O2|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
1186045|NCT00337662|O1|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1185999|NCT00337675|E2|Reported Event|Intermittent Montelukast|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
1186000|NCT00337675|E1|Reported Event|Daily Montelukast|Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
1186001|NCT00337662|B4|Baseline|Total|Total of all reporting groups
1186002|NCT00337662|B3|Baseline|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186003|NCT00337662|B2|Baseline|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186004|NCT00337662|B1|Baseline|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
1186005|NCT00337662|P4|Participant Flow|Risperiodone Open-Label Lead-In|"All patients completed a 2-week open-label risperidone lead-in period. This group contains all patients who started Study Period II.~Risperidone: 2-6 mg, oral, daily"
1186006|NCT00337662|P3|Participant Flow|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186007|NCT00337662|P2|Participant Flow|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186008|NCT00337662|P1|Participant Flow|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
1186009|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186010|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186011|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
1186012|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186013|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186014|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
1186015|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186016|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186017|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
1186018|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186019|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186020|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
1186021|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186022|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186023|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
1186024|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186025|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186026|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
1186027|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186028|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186029|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
1186030|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186031|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186032|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
1186033|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186034|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186035|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
1186036|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186037|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186038|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
1186039|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186040|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186041|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
1186042|NCT00337662|O2|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186047|NCT00337662|O1|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186048|NCT00337662|O2|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
1186049|NCT00337662|O1|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186051|NCT00337662|O1|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186052|NCT00337662|O2|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
1186053|NCT00337662|O1|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186054|NCT00337662|O2|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186055|NCT00337662|O1|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
1186056|NCT00337662|E3|Reported Event|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks.
1186057|NCT00337662|E2|Reported Event|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks.
1186058|NCT00337662|E1|Reported Event|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks.
1186059|NCT00337610|B3|Baseline|Total|Total of all reporting groups
1186060|NCT00337610|B2|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
1186061|NCT00337610|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
1186062|NCT00337610|P2|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
1186063|NCT00337610|P1|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
1186064|NCT00337610|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
1186065|NCT00337610|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
1186066|NCT00337610|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
1186067|NCT00337610|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
1186068|NCT00337610|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
1186069|NCT00337610|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
1186070|NCT00337610|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
1186071|NCT00337610|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
1186072|NCT00337610|E2|Reported Event|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
1186073|NCT00337610|E1|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
1186074|NCT00337571|B5|Baseline|Total|Total of all reporting groups
1186075|NCT00337571|B4|Baseline|Aripiprazole 15 mg|
1186076|NCT00337571|B3|Baseline|Aripiprazole 10 mg|
1186077|NCT00337571|B2|Baseline|Aripiprazole 5 mg|
1186078|NCT00337571|B1|Baseline|Placebo|
1186079|NCT00337571|P4|Participant Flow|Aripiprazole 15 mg|
1186080|NCT00337571|P3|Participant Flow|Aripiprazole 10 mg|
1186081|NCT00337571|P2|Participant Flow|Aripiprazole 5 mg|
1186082|NCT00337571|P1|Participant Flow|Placebo|
1186083|NCT00337571|O4|Outcome|Aripiprazole 15 mg|
1186084|NCT00337571|O3|Outcome|Aripiprazole 10 mg|
1186085|NCT00337571|O2|Outcome|Aripiprazole 5 mg|
1186086|NCT00337571|O1|Outcome|Placebo|
1186087|NCT00337571|O4|Outcome|Aripiprazole 15 mg|
1186088|NCT00337571|O3|Outcome|Aripiprazole 10 mg|
1186089|NCT00337571|O2|Outcome|Aripiprazole 5 mg|
1186090|NCT00337571|O1|Outcome|Placebo|
1186091|NCT00337571|O4|Outcome|Aripiprazole 15 mg|
1186092|NCT00337571|O3|Outcome|Aripiprazole 10 mg|
1186093|NCT00337571|O2|Outcome|Aripiprazole 5 mg|
1186094|NCT00337571|O1|Outcome|Placebo|
1186095|NCT00337571|O4|Outcome|Aripiprazole 15 mg|
1186096|NCT00337571|O3|Outcome|Aripiprazole 10 mg|
1186097|NCT00337571|O2|Outcome|Aripiprazole 5 mg|
1186119|NCT00337467|B1|Baseline|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
1186120|NCT00337467|P1|Participant Flow|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
1187313|NCT00332605|B2|Baseline|N-Acetyl Cysteine|600mg tablets taken by mouth daily
1186121|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
1186122|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
1186123|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
1186124|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
1186125|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
1186126|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
1186127|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
1186128|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
1186129|NCT00337467|O1|Outcome|Proportion of Participants|Proportion of participants without virologic rebound at the end of interval
1186130|NCT00337467|O1|Outcome|Proportion of Participants|Proportion of participants without treatment failure at the end of interval
1186131|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
1186132|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
1186133|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
1186134|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
1186135|NCT00337467|E1|Reported Event|ATV/RTV Monotherapy|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
1186136|NCT00337428|B3|Baseline|Total|Total of all reporting groups
1186137|NCT00337428|B2|Baseline|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
1186138|NCT00337428|B1|Baseline|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
1186139|NCT00337428|P2|Participant Flow|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
1186140|NCT00337428|P1|Participant Flow|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
1186141|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
1186142|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
1186143|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
1186144|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
1186145|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
1186146|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
1186147|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
1186148|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
1186149|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
1186150|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
1186151|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
1187314|NCT00332605|B1|Baseline|Naltrexone|Naltrexone tablets - 50mg pills taken by mouth daily
1186152|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
1186153|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
1186154|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
1186155|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
1186156|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
1186157|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
1186158|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
1186159|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
1186160|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
1186161|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
1186162|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
1186163|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
1186164|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
1186165|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
1186166|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
1186167|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
1186168|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
1186169|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
1186170|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
1186171|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
1186172|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
1186173|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
1186174|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
1186175|NCT00337428|E2|Reported Event|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
1186176|NCT00337428|E1|Reported Event|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
1186177|NCT00337350|B3|Baseline|Total|Total of all reporting groups
1186178|NCT00337350|B2|Baseline|Placebo|matched placebo for rosiglitazone 4mg/day
1186179|NCT00337350|B1|Baseline|Rosiglitazone|rosiglitazone 4mg/day
1186180|NCT00337350|P2|Participant Flow|Placebo|matched placebo for rosiglitazone 4mg/day
1186181|NCT00337350|P1|Participant Flow|Rosiglitazone|rosiglitazone 4mg/day
1186182|NCT00337350|O2|Outcome|Placebo|matched placebo for rosiglitazone 4mg/day
1186183|NCT00337350|O1|Outcome|Rosiglitazone|rosiglitazone 4mg/day
1186184|NCT00337350|O2|Outcome|Placebo|matched placebo for rosiglitazone 4mg/day
1186185|NCT00337350|O1|Outcome|Rosiglitazone|rosiglitazone 4mg/day
1186186|NCT00337350|O2|Outcome|Placebo|matched placebo for rosiglitazone 4mg/day
1186187|NCT00337350|O1|Outcome|Rosiglitazone|rosiglitazone 4mg/day
1186188|NCT00337350|E2|Reported Event|Placebo|matched placebo for rosiglitazone 4mg/day
1186190|NCT00337285|B1|Baseline|Vyvanse|Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
1186191|NCT00337285|P1|Participant Flow|Vyvanse|Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
1187315|NCT00332605|P3|Participant Flow|Placebo|
1186192|NCT00337285|O1|Outcome|Vyvanse|Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
1186193|NCT00337285|O1|Outcome|Vyvanse|Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
1186194|NCT00337285|O1|Outcome|Vyvanse|Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
1186195|NCT00337285|E1|Reported Event|Vyvanse|Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
1186196|NCT00337272|B3|Baseline|Total|Total of all reporting groups
1186197|NCT00337272|B2|Baseline|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
1186198|NCT00337272|B1|Baseline|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
1186199|NCT00337272|P2|Participant Flow|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
1186200|NCT00337272|P1|Participant Flow|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
1186201|NCT00337272|O2|Outcome|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
1186202|NCT00337272|O1|Outcome|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
1186203|NCT00337272|O2|Outcome|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
1186204|NCT00337272|O1|Outcome|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
1186205|NCT00337272|O2|Outcome|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
1186206|NCT00337272|O1|Outcome|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
1186207|NCT00337272|O2|Outcome|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
1186208|NCT00337272|O1|Outcome|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
1186209|NCT00337272|O2|Outcome|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
1186210|NCT00337272|O1|Outcome|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
1186211|NCT00337272|O2|Outcome|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
1186212|NCT00337272|O1|Outcome|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
1186213|NCT00337272|O2|Outcome|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
1186214|NCT00337272|O1|Outcome|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
1186215|NCT00337272|O2|Outcome|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
1186216|NCT00337272|O1|Outcome|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
1186217|NCT00337272|E2|Reported Event|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
1186218|NCT00337272|E1|Reported Event|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
1186219|NCT00337207|B1|Baseline|Study Treatment|All patients received bevacizumab 15 mg/kg every 3 weeks until progressive disease or unacceptable toxicity.
1186220|NCT00337207|P1|Participant Flow|Study Treatment|All patients received bevacizumab 15 mg/kg every 3 weeks until progressive disease or unacceptable toxicity.
1186221|NCT00337207|O1|Outcome|Study Treatment|All patients received bevacizumab 15 mg/kg every 3 weeks until progressive disease or unacceptable toxicity.
1186222|NCT00337207|E1|Reported Event|Study Treatment|All patients received bevacizumab 15 mg/kg every 3 weeks until progressive disease or unacceptable toxicity.
1186223|NCT00337194|B3|Baseline|Total|Total of all reporting groups
1186224|NCT00337194|B2|Baseline|Arm II (Placebo, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~placebo: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1186225|NCT00337194|B1|Baseline|Arm I (SGN-30, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~monoclonal antibody SGN-30: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1186271|NCT00337077|P2|Participant Flow|Prior Taxane|Patients who received one prior taxane regimen. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1186272|NCT00337077|P1|Participant Flow|Chemonaive|Patients who did not receive any prior chemotherapy. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1186430|NCT00336323|O1|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
1186274|NCT00337077|O2|Outcome|Prior Taxane|Patients who received one prior taxane regimen. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1199138|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
1186226|NCT00337194|P2|Participant Flow|Arm II (Placebo, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~placebo: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1186227|NCT00337194|P1|Participant Flow|Arm I (SGN-30, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~monoclonal antibody SGN-30: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1186228|NCT00337194|O2|Outcome|Non-responders|Subset of patients who did not achieve an overall response, as defined in primary outcome measure 1
1186229|NCT00337194|O1|Outcome|Responders|Subset of patients who achieved an overall response, as describer in primary outcome measure 1.
1186230|NCT00337194|O2|Outcome|Non-responders|Subset of patients who did not achieve an overall response, as defined in primary outcome measure 1
1186231|NCT00337194|O1|Outcome|Responders|Subset of patients who achieved an overall response, as describer in primary outcome measure 1.
1186232|NCT00337194|O1|Outcome|Arm I (SGN-30, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~monoclonal antibody SGN-30: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1186233|NCT00337194|O2|Outcome|Arm II (Placebo, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~placebo: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1186234|NCT00337194|O1|Outcome|Arm I (SGN-30, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~monoclonal antibody SGN-30: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1186235|NCT00337194|O2|Outcome|Arm II (Placebo, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~placebo: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1186236|NCT00337194|O1|Outcome|Arm I (SGN-30, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~monoclonal antibody SGN-30: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1186237|NCT00337194|O2|Outcome|Arm II (Placebo, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~placebo: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1186273|NCT00337077|O3|Outcome|Two Prior Chemotherapy Regimens|Patients who received two prior chemotherapy regimens. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1186306|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
1186238|NCT00337194|O1|Outcome|Arm I (SGN-30, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~monoclonal antibody SGN-30: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1186239|NCT00337194|E2|Reported Event|Arm II (Placebo, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~placebo: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharma"
1186240|NCT00337194|E1|Reported Event|Arm I (SGN-30, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~monoclonal antibody SGN-30: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1186241|NCT00337168|B1|Baseline|Induction|
1186242|NCT00337168|P1|Participant Flow|Induction|Clofarabine (40 mg per meters squared per day) and cytarabine (1 g per meters squared per day)
1186243|NCT00337168|O1|Outcome|Induction|Up to two induction cycles with clofarabine and cytarabine
1186244|NCT00337168|O1|Outcome|Induction|
1186245|NCT00337168|O1|Outcome|Induction|
1186246|NCT00337168|O1|Outcome|Induction|
1186247|NCT00337168|E1|Reported Event|Induction|Up to two induction cycles with clofarabine and cytarabine
1186248|NCT00337129|B1|Baseline|Treatment (E7389 IV)|Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
1186249|NCT00337129|P1|Participant Flow|Treatment (E7389 IV)|Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
1186250|NCT00337129|O1|Outcome|Treatment (E7389 IV)|Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
1186251|NCT00337129|O1|Outcome|Treatment (E7389 IV)|Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
1186252|NCT00337129|O1|Outcome|Treatment (E7389 IV)|Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
1186253|NCT00337129|O1|Outcome|Treatment (E7389 IV)|Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
1186254|NCT00337129|E1|Reported Event|Treatment (E7389 IV)|Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle. Includes only patients who received drug.
1186255|NCT00337103|B3|Baseline|Total|Total of all reporting groups
1186256|NCT00337103|B2|Baseline|Capecitabine 2.5 g/m^2/Day|Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days
1186257|NCT00337103|B1|Baseline|Eribulin Mesylate 1.4 mg/m^2|Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days
1186258|NCT00337103|P2|Participant Flow|Capecitabine 2.5 g/m^2/Day|Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days
1186259|NCT00337103|P1|Participant Flow|Eribulin Mesylate 1.4 mg/m^2|Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days
1186260|NCT00337103|O2|Outcome|Capecitabine 2.5 g/m^2/Day|Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days
1186261|NCT00337103|O1|Outcome|Eribulin Mesylate 1.4 mg/m^2|Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days
1186262|NCT00337103|O2|Outcome|Capecitabine 2.5 g/m^2/Day|Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days
1186263|NCT00337103|O1|Outcome|Eribulin Mesylate 1.4 mg/m^2|Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days
1186264|NCT00337103|E2|Reported Event|Capecitabine 2.5 g/m^2/Day|Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days
1186265|NCT00337103|E1|Reported Event|Eribulin Mesylate 1.4 mg/m^2|Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days
1186266|NCT00337077|B4|Baseline|Total|Total of all reporting groups
1186267|NCT00337077|B3|Baseline|Two Prior Chemotherapy Regimens|Patients who received two prior chemotherapy regimens. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1186268|NCT00337077|B2|Baseline|Prior Taxane|Patients who received one prior taxane regimen. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1186269|NCT00337077|B1|Baseline|Chemonaive|Patients who did not receive any prior chemotherapy. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1186270|NCT00337077|P3|Participant Flow|Two Prior Chemotherapy Regimens|Patients who received two prior chemotherapy regimens. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1186305|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days"
1186275|NCT00337077|O1|Outcome|Chemonaive|Patients who did not receive any prior chemotherapy. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1186276|NCT00337077|O3|Outcome|Two Prior Chemotherapy Regimens|Patients who received two prior chemotherapy regimens. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1186277|NCT00337077|O2|Outcome|Prior Taxane|Patients who received one prior taxane regimen. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1186278|NCT00337077|O1|Outcome|Chemonaive|Patients who did not receive any prior chemotherapy. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1186279|NCT00337077|E1|Reported Event|Eribulin Mesylate|All treated patients are evaluated for toxicities except for one patient who died soon after starting treatment and was not assessed for toxicity.
1186280|NCT00336973|B1|Baseline|Efalizumab|After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
1186281|NCT00336973|P1|Participant Flow|Efalizumab|After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
1186282|NCT00336973|O1|Outcome|Efalizumab|After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
1186283|NCT00336973|O1|Outcome|Efalizumab|After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
1186284|NCT00336973|O1|Outcome|Efalizumab|After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
1186285|NCT00336973|O1|Outcome|Efalizumab|After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
1186286|NCT00336895|B1|Baseline|Liver Transplant Subjects|"All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.~Myfortic: Myfortic 360mg or 720 mg BID for 90 days."
1186287|NCT00336895|P1|Participant Flow|Liver Transplant Subjects|"All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.~Myfortic: Myfortic 360mg or 720 mg BID for 90 days."
1186288|NCT00336895|O1|Outcome|Liver Transplant Subjects|"All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.~Myfortic: Myfortic 360mg or 720 mg BID for 90 days."
1186289|NCT00336895|O1|Outcome|Liver Transplant Subjects|"All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.~Myfortic: Myfortic 360mg or 720 mg BID for 90 days."
1186290|NCT00336895|O1|Outcome|Liver Transplant Subjects|"All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.~Myfortic: Myfortic 360mg or 720 mg BID for 90 days."
1186291|NCT00336895|E1|Reported Event|Liver Transplant Subjects|"All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.~Myfortic: Myfortic 360mg or 720 mg BID for 90 days."
1186292|NCT00336856|B1|Baseline|IRINOTECAN AND CETUXIMAB|Subjects with metastatic, CRC who have failed a first-line chemotherapeutic regimen containing oxaliplatin and a fluoropyrimidine, and who have not previously received irinotecan or cetuximab for treatment of CRC who received Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV), followed by 500 mg/m2 every 2 weeks IV
1186293|NCT00336856|P1|Participant Flow|IRINOTECAN AND CETUXIMAB|Subjects with metastatic, CRC who have failed a first-line chemotherapeutic regimen containing oxaliplatin and a fluoropyrimidine, and who have not previously received irinotecan or cetuximab for treatment of CRC
1186294|NCT00336856|O1|Outcome|IRINOTECAN AND CETUXIMAB|"Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV) over 120 minutes, followed by 500 mg/m2 every 2 weeks IV over 60 minutes.~Irinotecan administered at a dose of 150 or 180 mg/m2 IV over 60 minutes every two weeks."
1186295|NCT00336856|O1|Outcome|IRINOTECAN AND CETUXIMAB|"Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV) over 120 minutes, followed by 500 mg/m2 every 2 weeks IV over 60 minutes.~Irinotecan administered at a dose of 150 or 180 mg/m2 IV over 60 minutes every two weeks."
1186296|NCT00336856|O1|Outcome|IRINOTECAN AND CETUXIMAB|"Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV) over 120 minutes, followed by 500 mg/m2 every 2 weeks IV over 60 minutes.~Irinotecan administered at a dose of 150 or 180 mg/m2 IV over 60 minutes every two weeks."
1186297|NCT00336856|E1|Reported Event|IRINOTECAN AND CETUXIMAB|"Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV) over 120 minutes, followed by 500 mg/m2 every 2 weeks IV over 60 minutes.~Irinotecan administered at a dose of 150 or 180 mg/m2 IV over 60 minutes every two weeks."
1186298|NCT00336817|B3|Baseline|Total|Total of all reporting groups
1186299|NCT00336817|B2|Baseline|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days"
1186300|NCT00336817|B1|Baseline|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
1186301|NCT00336817|P2|Participant Flow|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days"
1186302|NCT00336817|P1|Participant Flow|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
1186303|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days"
1186304|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
1186307|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days"
1187316|NCT00332605|P2|Participant Flow|N-Acetyl Cysteine|600mg tablets taken by mouth daily
1186308|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
1186309|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days~Results: 2 participants in the CellCept group discontinued drug use"
1186310|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days~Results: 1 participant in the Myfortic arm left at 6 weeks into the study to start hemodialysis"
1186311|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days~Results: 2 participants in the CellCept group discontinued drug use"
1186312|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days~Results: 1 participant in the Myfortic arm left at 6 weeks into the study to start hemodialysis"
1186313|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days"
1186314|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
1186315|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days"
1186316|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
1186317|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days"
1186318|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
1186319|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days"
1186320|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
1186321|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days"
1186322|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
1186323|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days"
1186324|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
1186325|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days"
1186326|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
1186327|NCT00336817|O2|Outcome|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days"
1186328|NCT00336817|O1|Outcome|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
1186329|NCT00336817|E2|Reported Event|CellCept Group|"Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days~CellCept: CellCept 500mg or 1000mg BID for 90 days"
1186330|NCT00336817|E1|Reported Event|Myfortic Group|"Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days~Myfortic: Myfortic 360mg or 720 mg BID for 90 days"
1186331|NCT00336700|B1|Baseline|Gemcitabine (900-1500 mg/m2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
1186332|NCT00336700|P1|Participant Flow|Gemcitabine (900-1500 mg/m2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
1186333|NCT00336700|O1|Outcome|Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
1186334|NCT00336700|O1|Outcome|Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
1186335|NCT00336700|O1|Outcome|Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
1186336|NCT00336700|O1|Outcome|Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
1186337|NCT00336700|O1|Outcome|Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
1186338|NCT00336700|O1|Outcome|Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
1186433|NCT00336323|O1|Outcome|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
1186340|NCT00336583|B1|Baseline|ESHAOx|The ESHAOx consisted of Etoposide (40 mg per square meter on days 1–4), Methylprednisolone (500 mg on days 1–5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles.
1186341|NCT00336583|P1|Participant Flow|ESHAOx|The ESHAOx consisted of Etoposide (40 mg per square meter on days 1–4), Methylprednisolone (500 mg on days 1–5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles.
1186342|NCT00336583|O1|Outcome|ESHAOx|The ESHAOx consisted of Etoposide (40 mg per square meter on days 1–4), Methylprednisolone (500 mg on days 1–5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles.
1186343|NCT00336583|O1|Outcome|ESHAOx|The ESHAOx consisted of Etoposide (40 mg per square meter on days 1–4), Methylprednisolone (500 mg on days 1–5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles.
1186344|NCT00336583|E1|Reported Event|ESHAOx|The ESHAOx consisted of Etoposide (40 mg per square meter on days 1–4), Methylprednisolone (500 mg on days 1–5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles.
1186345|NCT00336544|B3|Baseline|Total|Total of all reporting groups
1186346|NCT00336544|B2|Baseline|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
1186347|NCT00336544|B1|Baseline|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
1186348|NCT00336544|P2|Participant Flow|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
1186349|NCT00336544|P1|Participant Flow|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
1186350|NCT00336544|O2|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
1186351|NCT00336544|O1|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
1186352|NCT00336544|O2|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
1186353|NCT00336544|O1|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
1186354|NCT00336544|O2|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
1186355|NCT00336544|O1|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
1186356|NCT00336544|O2|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
1186357|NCT00336544|O1|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
1186358|NCT00336544|E2|Reported Event|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
1186359|NCT00336544|E1|Reported Event|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
1186360|NCT00336505|B3|Baseline|Total|Total of all reporting groups
1186361|NCT00336505|B2|Baseline|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
1186362|NCT00336505|B1|Baseline|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
1186363|NCT00336505|P2|Participant Flow|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
1186364|NCT00336505|P1|Participant Flow|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
1186365|NCT00336505|O2|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
1186366|NCT00336505|O1|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
1186367|NCT00336505|O2|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
1186368|NCT00336505|O1|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
1186369|NCT00336505|O2|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
1186370|NCT00336505|O1|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
1186371|NCT00336505|O2|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
1186372|NCT00336505|O1|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
1186373|NCT00336505|E2|Reported Event|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
1186374|NCT00336505|E1|Reported Event|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
1186375|NCT00336492|B4|Baseline|Total|Total of all reporting groups
1186376|NCT00336492|B3|Baseline|5 mg/kg Infliximab Every 12 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 12 wks
1186377|NCT00336492|B2|Baseline|5 mg/kg Infliximab Every 8 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 8 wks
1186378|NCT00336492|B1|Baseline|Not Randomized Group|Participants who were not randomized at Week 8
1186379|NCT00336492|P3|Participant Flow|5 mg/kg Infliximab Every 12 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 12 wks
1186380|NCT00336492|P2|Participant Flow|5 mg/kg Infliximab Every 8 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 8 wks
1186381|NCT00336492|P1|Participant Flow|Not Randomized Group|Participants who were not randomized at Week 8
1186382|NCT00336492|O2|Outcome|5 mg/kg Infliximab Every 12 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 12 wks
1186383|NCT00336492|O1|Outcome|5 mg/kg Infliximab Every 8 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 8 wks
1186384|NCT00336492|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg group
1186385|NCT00336492|E3|Reported Event|5 mg/kg Infliximab Every 12 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 12 wks
1186386|NCT00336492|E2|Reported Event|5 mg/kg Infliximab Every 8 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 8 wks
1186387|NCT00336492|E1|Reported Event|Not Randomized Group|Participants who were not randomized at Week 8
1186388|NCT00336479|B5|Baseline|Total|Total of all reporting groups
1186431|NCT00336323|O1|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
1186432|NCT00336323|O1|Outcome|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
1186389|NCT00336479|B4|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
1186390|NCT00336479|B3|Baseline|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
1186391|NCT00336479|B2|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
1186392|NCT00336479|B1|Baseline|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
1186393|NCT00336479|P4|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
1186394|NCT00336479|P3|Participant Flow|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
1186395|NCT00336479|P2|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
1186396|NCT00336479|P1|Participant Flow|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
1186397|NCT00336479|O1|Outcome|Telaprevir|All Subjects from “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week”, “Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week”, and “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week” reporting groups who received single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks.
1186398|NCT00336479|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
1186399|NCT00336479|O3|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
1186400|NCT00336479|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
1186401|NCT00336479|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
1186402|NCT00336479|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
1186403|NCT00336479|O3|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
1186404|NCT00336479|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
1186405|NCT00336479|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
1195570|NCT00313144|O1|Outcome|Baseline to ≤6 Months|
1186406|NCT00336479|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
1186407|NCT00336479|O3|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
1186408|NCT00336479|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
1186409|NCT00336479|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
1186410|NCT00336479|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
1186411|NCT00336479|O3|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
1186412|NCT00336479|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
1186413|NCT00336479|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
1186414|NCT00336479|E4|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
1186415|NCT00336479|E3|Reported Event|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
1186416|NCT00336479|E2|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
1186417|NCT00336479|E1|Reported Event|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
1186418|NCT00336323|B6|Baseline|Total|Total of all reporting groups
1186419|NCT00336323|B5|Baseline|1.25 mg Injection at Baseline, Laser at 3w + 1.25 mg Inj at 3w|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
1186420|NCT00336323|B4|Baseline|1.25 mg Injection at Baseline Only|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
1186421|NCT00336323|B3|Baseline|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
1186422|NCT00336323|B2|Baseline|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
1186423|NCT00336323|B1|Baseline|Laser at Baseline|Laser photocoagulation at baseline: If edema is present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
1186424|NCT00336323|P5|Participant Flow|1.25 mg Injection at Baseline, Laser at 3w + 1.25 mg Inj at 3w|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
1186425|NCT00336323|P4|Participant Flow|1.25 mg Injection at Baseline Only|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
1186426|NCT00336323|P3|Participant Flow|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
1186427|NCT00336323|P2|Participant Flow|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
1186428|NCT00336323|P1|Participant Flow|Laser at Baseline|Laser photocoagulation at baseline: If edema is present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
1186429|NCT00336323|O1|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
1186434|NCT00336323|O1|Outcome|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
1186435|NCT00336323|O1|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
1186436|NCT00336323|O1|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
1186437|NCT00336323|O1|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
1186438|NCT00336323|O1|Outcome|Pooled 1.25mg Initial Bevacizumab Injection Groups|The following are the treatment groups included in the Pooled 1.25mg Bevacizumab Groups: 1.25mg at baseline and 6 weeks; and 1.25mg at baseline only
1186439|NCT00336323|O1|Outcome|Pooled 1.25mg Initial Bevacizumab Injection Groups|The following are the treatment groups included in the Pooled 1.25mg Bevacizumab Groups: 1.25mg at baseline and 6 weeks; and 1.25mg at baseline only
1186440|NCT00336323|O1|Outcome|Pooled 1.25mg Initial Bevacizumab Injection Groups|The following are the treatment groups included in the Pooled 1.25mg Bevacizumab Groups: 1.25mg at baseline and 6 weeks; and 1.25mg at baseline only
1186441|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
1186442|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
1186443|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
1186444|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
1186445|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
1186446|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
1186447|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
1186448|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
1186449|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
1186450|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
1186451|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
1186452|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
1186453|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
1186454|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
1186455|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
1186456|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
1186457|NCT00336323|O5|Outcome|1.25 mg Injection at Baseline, Laser at 3w + 1.25 mg Inj at 3w|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
1186458|NCT00336323|O4|Outcome|1.25 mg Injection at Baseline Only|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
1186459|NCT00336323|O3|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
1186460|NCT00336323|O2|Outcome|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
1186461|NCT00336323|O1|Outcome|Laser at Baseline|Laser photocoagulation at baseline: If edema is present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
1186462|NCT00336323|O5|Outcome|1.25 mg Injection at Baseline, Laser at 3w + 1.25 mg Inj at 3w|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
1186463|NCT00336323|O4|Outcome|1.25 mg Injection at Baseline Only|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
1186464|NCT00336323|O3|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
1186465|NCT00336323|O2|Outcome|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
1186466|NCT00336323|O1|Outcome|Laser at Baseline|Laser photocoagulation at baseline: If edema is present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
1186467|NCT00336323|O5|Outcome|1.25 mg Injection at Baseline, Laser at 3w + 1.25 mg Inj at 3w|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
1186468|NCT00336323|O4|Outcome|1.25 mg Injection at Baseline Only|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
1186469|NCT00336323|O3|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
1186470|NCT00336323|O2|Outcome|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
1186471|NCT00336323|O1|Outcome|Laser at Baseline|Laser photocoagulation at baseline: If edema is present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
1186472|NCT00336323|O5|Outcome|1.25 mg Injection at Baseline, Laser at 3w + 1.25 mg Inj at 3w|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
1186473|NCT00336323|O4|Outcome|1.25 mg Injection at Baseline Only|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
1186474|NCT00336323|O3|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
1186475|NCT00336323|O2|Outcome|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
1186476|NCT00336323|O1|Outcome|Laser at Baseline|Laser photocoagulation at baseline: If edema is present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
1186477|NCT00336323|E5|Reported Event|1.25 mg Injection at Baseline, Laser at 3w + 1.25 mg Inj at 3w|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
1186478|NCT00336323|E4|Reported Event|1.25 mg Injection at Baseline Only|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
1186479|NCT00336323|E3|Reported Event|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
1186480|NCT00336323|E2|Reported Event|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
1186481|NCT00336323|E1|Reported Event|Laser at Baseline|Laser photocoagulation at baseline: If edema is present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
1186482|NCT00336284|B3|Baseline|Total|Total of all reporting groups
1186483|NCT00336284|B2|Baseline|Conventional|Home Monitoring programmed OFF
1186484|NCT00336284|B1|Baseline|Home Monitoring|Home Monitoring programmed ON
1186485|NCT00336284|P2|Participant Flow|Conventional|Home Monitoring programmed OFF
1186486|NCT00336284|P1|Participant Flow|Home Monitoring|Home Monitoring programmed ON
1186487|NCT00336284|O2|Outcome|Conventional|Home Monitoring programmed OFF
1186488|NCT00336284|O1|Outcome|Home Monitoring|Home Monitoring programmed ON
1186489|NCT00336284|O2|Outcome|Conventional|Home Monitoring programmed OFF
1186490|NCT00336284|O1|Outcome|Home Monitoring|Home Monitoring programmed ON
1186491|NCT00336284|O2|Outcome|Conventional|Home Monitoring programmed OFF
1186492|NCT00336284|O1|Outcome|Home Monitoring|Home Monitoring programmed ON
1186493|NCT00336284|O2|Outcome|Conventional|Home Monitoring programmed OFF
1186494|NCT00336284|O1|Outcome|Home Monitoring|Home Monitoring programmed ON
1186495|NCT00336284|E2|Reported Event|Conventional|Home Monitoring programmed OFF
1186496|NCT00336284|E1|Reported Event|Home Monitoring|Home Monitoring programmed ON
1186497|NCT00336232|B1|Baseline|Diet Intervention|"5 day baseline vitamin K~Vitamin K: phylloquinone (vitamin K1) 200 mcg daily~28 day diet low vitamin K~Vitamin K: phylloquinone (vitamin K1) approx. 10 mcg daily for 28 days~treatment started day 6, completed day 33~28 day diet high vitamin K~Vitamin K: phylloquinone (vitamin K1) 500 mcg daily in third month~treatment started day 34, ended day 61"
1186498|NCT00336232|P1|Participant Flow|Vitamin K Diet Intervention|"5 day baseline vitamin K~Vitamin K: phylloquinone (vitamin K1) 200 mcg daily~28 day diet low vitamin K~Vitamin K: phylloquinone (vitamin K1) approx. 10 mcg daily for 28 days~treatment started day 6, completed day 33~28 day diet high vitamin K~Vitamin K: phylloquinone (vitamin K1) 500 mcg daily in third month~treatment started day 34, ended day 61"
1186499|NCT00336232|O1|Outcome|Diet Intervention|"5 day baseline vitamin K~Vitamin K: phylloquinone (vitamin K1) 200 mcg daily~28 day diet low vitamin K~Vitamin K: phylloquinone (vitamin K1) approx. 10 mcg daily for 28 days~treatment started day 6, completed day 33~28 day diet high vitamin K~Vitamin K: phylloquinone (vitamin K1) 500 mcg daily in third month~treatment started day 34, ended day 61"
1186500|NCT00336232|E1|Reported Event|Diet Intervention|"5 day baseline vitamin K~Vitamin K: phylloquinone (vitamin K1) 200 mcg daily~28 day diet low vitamin K~Vitamin K: phylloquinone (vitamin K1) approx. 10 mcg daily for 28 days~treatment started day 6, completed day 33~28 day diet high vitamin K~Vitamin K: phylloquinone (vitamin K1) 500 mcg daily in third month~treatment started day 34, ended day 61"
1186501|NCT00335959|B1|Baseline|Chemotherapy, Chemoradiation, Surgery|Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
1186502|NCT00335959|P1|Participant Flow|Chemotherapy, Chemoradiation, Surgery|Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
1186812|NCT00334282|O2|Outcome|Placebo|Matching Placebo administered orally once a day
1186552|NCT00335556|E2|Reported Event|UH-1|Cyclophosphamide/carboplatin/etoposide;vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT
1186503|NCT00335959|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
1186504|NCT00335959|O1|Outcome|Chemotherapy, Chemoradiation and Surgery|Patients were to receive Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
1186505|NCT00335959|E1|Reported Event|Chemotherapy, Chemoradiation and Surgery|Patients were to receive Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
1186506|NCT00335777|B1|Baseline|Migranal: All Subjects|All subjects enrolled in study
1186507|NCT00335777|P1|Participant Flow|Migranal: All Subjects|All subjects enrolled in study
1186508|NCT00335777|O2|Outcome|Migranal Late Treatment|Treated a headache at greater or equal to 3.5 hours after onset of throbbing
1186509|NCT00335777|O1|Outcome|Migranal: Early Treatment|Treated headache within 1.25 hours of onset of throbbing
1186510|NCT00335777|E1|Reported Event|Migranal: All Subjects|All subjects enrolled in study
1186511|NCT00335725|B3|Baseline|Total|Total of all reporting groups
1186512|NCT00335725|B2|Baseline|Gonal-f|
1186513|NCT00335725|B1|Baseline|Fostimon|
1186514|NCT00335725|P2|Participant Flow|Gonal-f|Recombinant FSH
1186515|NCT00335725|P1|Participant Flow|Fostimon|Highly purified FSH
1186516|NCT00335725|O2|Outcome|Gonal-F|
1186517|NCT00335725|O1|Outcome|Fostimon|
1186518|NCT00335725|O2|Outcome|Gonal-f|
1186519|NCT00335725|O1|Outcome|Fostimon|
1186520|NCT00335725|E2|Reported Event|Gonal-F|
1186521|NCT00335725|E1|Reported Event|Fostimon|
1186522|NCT00335556|B7|Baseline|Total|Total of all reporting groups
1186523|NCT00335556|B6|Baseline|Regimen DD-4A|Vincristine/dactinomycin/doxorubicin x25 weeks; XRT.
1186524|NCT00335556|B5|Baseline|Regimen I|Vincristine/doxorubicin/cyclophosphamide; cyclophosphamide/etoposide x25 weeks; XRT.
1186525|NCT00335556|B4|Baseline|UH-2|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT.
1186526|NCT00335556|B3|Baseline|Window/UH-1|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
1186527|NCT00335556|B2|Baseline|UH-1|Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
1186528|NCT00335556|B1|Baseline|Surgery|Surgery Only
1186529|NCT00335556|P6|Participant Flow|Regimen DD-4A|Vincristine/dactinomycin/doxorubicin x25 weeks; XRT.
1186530|NCT00335556|P5|Participant Flow|Regimen I|Vincristine/doxorubicin/cyclophosphamide; cyclophosphamide/etoposide x25 weeks; XRT.
1186531|NCT00335556|P4|Participant Flow|UH-2|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT.
1186532|NCT00335556|P3|Participant Flow|Window/UH-1|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
1186533|NCT00335556|P2|Participant Flow|UH-1|Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
1186534|NCT00335556|P1|Participant Flow|Surgery|Surgery Only
1186535|NCT00335556|O4|Outcome|Regimen DD-4A|Vincristine/dactinomycin/doxorubicin x25 weeks; XRT
1186536|NCT00335556|O3|Outcome|UH-2|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT
1186537|NCT00335556|O2|Outcome|Window/UH-1|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide;vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
1186538|NCT00335556|O1|Outcome|UH-1|Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide;x 30 weeks; XRT.
1186539|NCT00335556|O2|Outcome|Window/UH-1|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
1186540|NCT00335556|O1|Outcome|UH-1|Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
1186541|NCT00335556|O1|Outcome|Combined UH-2, UH-1, Window/UH-1|Combined UH-1, UH-2, and Window/UH-1 for revised-UH toxicity monitoring
1186542|NCT00335556|O1|Outcome|Regimen DD-4A|Vincristine/dactinomycin/doxorubicin x25 weeks; XRT.
1186543|NCT00335556|O1|Outcome|Combined Window/UH-1 and UH-2|Combine window/UH-1 and UH-2 for response rate monitoring for window therapy.
1186544|NCT00335556|O1|Outcome|UH-1|Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphamide; x 30 weeks; XRT.
1186545|NCT00335556|O3|Outcome|UH-2|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT.
1186546|NCT00335556|O2|Outcome|Window/UH-1|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
1186547|NCT00335556|O1|Outcome|UH-1|Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT.
1186548|NCT00335556|E6|Reported Event|Regimen DD-4A|"Vincristine/dactinomycin/doxorubicin x25 weeks; XRT"
1186549|NCT00335556|E5|Reported Event|Regimen I|Vincristine/doxorubicin/cyclophosphamide; cyclophosphamide/etoposide x25 weeks; XRT
1186550|NCT00335556|E4|Reported Event|UH-2|Window therapy of vincristine/irinotecan;Cyclophosphamide/carboplatin/etoposide; vincristine/doxorubicin/cyclophosphomide; x 36 weeks; XRT
1186551|NCT00335556|E3|Reported Event|Window/UH-1|"Window therapy of vincristine/irinotecan; Cyclophosphamide/carboplatin/etoposide;vincristine/doxorubicin/cyclophosphomide; x 30 weeks; XRT"
1186813|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
1186560|NCT00335504|B3|Baseline|Arm III (Oligofructose-enriched Inulin)|Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
1186561|NCT00335504|B2|Baseline|Arm II (Sulindac)|Patients receive 150 mg tablet oral sulindac twice daily.
1186562|NCT00335504|B1|Baseline|Arm I (Atorvastatin Calcium)|Patients receive 20 mg tablet oral atorvastatin once daily.
1186563|NCT00335504|P4|Participant Flow|Arm IV (Placebo)|Patients receive an oral placebo (maltodextrin powder) twice daily.
1186564|NCT00335504|P3|Participant Flow|Arm III (Oligofructose-enriched Inulin)|Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
1186565|NCT00335504|P2|Participant Flow|Arm II (Sulindac)|Patients receive 150 mg tablet oral sulindac twice daily.
1186566|NCT00335504|P1|Participant Flow|Arm I (Atorvastatin Calcium)|Patients receive 20 mg tablet oral atorvastatin once daily.
1186567|NCT00335504|O4|Outcome|Arm IV (Placebo)|Patients receive an oral placebo (maltodextrin powder) twice daily.
1186568|NCT00335504|O3|Outcome|Arm III (Oligofructose-enriched Inulin)|Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
1186569|NCT00335504|O2|Outcome|Arm II (Sulindac)|Patients receive 150 mg tablet oral sulindac twice daily.
1186570|NCT00335504|O1|Outcome|Arm I (Atorvastatin Calcium)|Patients receive 20 mg tablet oral atorvastatin once daily.
1186571|NCT00335504|O4|Outcome|Arm IV (Placebo)|Patients receive an oral placebo (maltodextrin powder) twice daily.
1186572|NCT00335504|O3|Outcome|Arm III (Oligofructose-enriched Inulin)|Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
1186573|NCT00335504|O2|Outcome|Arm II (Sulindac)|Patients receive 150 mg tablet oral sulindac twice daily.
1186574|NCT00335504|O1|Outcome|Arm I (Atorvastatin Calcium)|Patients receive 20 mg tablet oral atorvastatin once daily.
1186575|NCT00335504|O4|Outcome|Arm IV (Placebo)|Patients receive an oral placebo (maltodextrin powder) twice daily.
1186576|NCT00335504|O3|Outcome|Arm III (Oligofructose-enriched Inulin)|Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
1186577|NCT00335504|O2|Outcome|Arm II (Sulindac)|Patients receive 150 mg tablet oral sulindac twice daily.
1186578|NCT00335504|O1|Outcome|Arm I (Atorvastatin Calcium)|Patients receive 20 mg tablet oral atorvastatin once daily.
1186579|NCT00335504|O4|Outcome|Arm IV (Placebo)|Patients receive an oral placebo (maltodextrin powder) twice daily.
1186580|NCT00335504|O3|Outcome|Arm III (Oligofructose-enriched Inulin)|Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
1186581|NCT00335504|O2|Outcome|Arm II (Sulindac)|Patients receive 150 mg tablet oral sulindac twice daily.
1186582|NCT00335504|O1|Outcome|Arm I (Atorvastatin Calcium)|Patients receive 20 mg tablet oral atorvastatin once daily.
1186583|NCT00335504|E4|Reported Event|Arm IV (Placebo)|Patients receive an oral placebo (maltodextrin powder) twice daily.
1186584|NCT00335504|E3|Reported Event|Arm III (Oligofructose-enriched Inulin)|Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
1186585|NCT00335504|E2|Reported Event|Arm II (Sulindac)|Patients receive 150 mg tablet oral sulindac twice daily.
1186586|NCT00335504|E1|Reported Event|Arm I (Atorvastatin Calcium)|Patients receive 20 mg tablet oral atorvastatin once daily.
1186587|NCT00335478|B1|Baseline|Daptomycin|6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is >500 cells/mm^3.
1186588|NCT00335478|P1|Participant Flow|Daptomycin|6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is >500 cells/mm^3.
1186589|NCT00335478|O1|Outcome|Daptomycin|6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is >500 cells/mm^3.
1186590|NCT00335478|E1|Reported Event|Daptomycin|6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is >500 cells/mm^3.
1186591|NCT00335452|B5|Baseline|Total|Total of all reporting groups
1186592|NCT00335452|B4|Baseline|Clopidogrel 600/150/75 mg + ASA High Dose|
1186593|NCT00335452|B3|Baseline|Clopidogrel 600/150/75 mg + ASA Low Dose|
1186594|NCT00335452|B2|Baseline|Clopidogrel 300/75/75 mg + ASA High Dose|
1186595|NCT00335452|B1|Baseline|Clopidogrel 300/75/75 mg + ASA Low Dose|
1186596|NCT00335452|P4|Participant Flow|Clopidogrel 600/150/75 mg + ASA High Dose|"Day 1: Clopidogrel 600 mg loading dose + ASA ≥ 300 mg~Day 2 to Day 7: Clopidogrel 150 mg + ASA 300-325 mg~Day 8 to Day 30: Clopidogrel 75 mg + ASA 300-325 mg"
1186597|NCT00335452|P3|Participant Flow|Clopidogrel 600/150/75 mg + ASA Low Dose|"Day 1: Clopidogrel 600 mg loading dose + ASA ≥ 300 mg~Day 2 to Day 7: Clopidogrel 150 mg + ASA 75-100 mg~Day 8 to Day 30: Clopidogrel 75 mg + ASA 75-100 mg"
1186598|NCT00335452|P2|Participant Flow|Clopidogrel 300/75/75 mg + ASA High Dose|"Day 1: Clopidogrel 300 mg loading dose + ASA ≥ 300 mg~Day 2 to Day 7: Clopidogrel 75 mg + ASA 300-325 mg~Day 8 to Day 30: Clopidogrel 75 mg + ASA 300-325 mg"
1186599|NCT00335452|P1|Participant Flow|Clopidogrel 300/75/75 mg + ASA Low Dose|"Day 1: Clopidogrel 300 mg loading dose + ASA ≥ 300 mg~Day 2 to Day 7: Clopidogrel 75 mg + ASA 75-100 mg~Day 8 to Day 30: Clopidogrel 75 mg + ASA 75-100 mg"
1186600|NCT00335452|O2|Outcome|Clopidogrel 600/150/75 mg + ASA|Patients randomized to the Clopidogrel 600/150/75 mg dose regimen irrespective of the ASA dose
1186601|NCT00335452|O1|Outcome|Clopidogrel 300/75/75 mg + ASA|Patients randomized to the Clopidogrel 300/75/75 mg dose regimen irrespective of the ASA dose
1186602|NCT00335452|O2|Outcome|Clopidogrel + ASA High Dose|Patients treated with ASA high dose irrespective of the Clopidogrel treatment regimen
1186603|NCT00335452|O1|Outcome|Clopidogrel + ASA Low Dose|Patients treated with ASA low dose irrespective of the Clopidogrel treatment regimen
1195571|NCT00313144|O5|Outcome|>18 Months to ≤24 Months|
1186604|NCT00335452|O2|Outcome|Clopidogrel 600/150/75 mg + ASA|Patients randomized to the Clopidogrel 600/150/75 mg dose regimen irrespective of the ASA dose
1186605|NCT00335452|O1|Outcome|Clopidogrel 300/75/75 mg + ASA|Patients randomized to the Clopidogrel 300/75/75 mg dose regimen irrespective of the ASA dose
1186606|NCT00335452|O4|Outcome|Clopidogrel 600/150/75 mg + ASA High Dose|
1186607|NCT00335452|O3|Outcome|Clopidogrel 600/150/75 mg + ASA Low Dose|
1186608|NCT00335452|O2|Outcome|Clopidogrel 300/75/75 mg + ASA High Dose|
1186609|NCT00335452|O1|Outcome|Clopidogrel 300/75/75 mg + ASA Low Dose|
1199139|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
1186610|NCT00335452|O2|Outcome|Clopidogrel + ASA High Dose|Patients treated with ASA high dose irrespective of the Clopidogrel treatment regimen
1186611|NCT00335452|O1|Outcome|Clopidogrel + ASA Low Dose|Patients treated with ASA low dose irrespective of the Clopidogrel treatment regimen
1186612|NCT00335452|O2|Outcome|Clopidogrel 600/150/75 mg + ASA|Patients randomized to the Clopidogrel 600/150/75 mg dose regimen irrespective of the ASA dose.
1186613|NCT00335452|O1|Outcome|Clopidogrel 300/75/75 mg + ASA|Patients randomized to the Clopidogrel 300/75/75 mg dose regimen irrespective of the ASA dose
1186614|NCT00335452|O2|Outcome|Clopidogrel 600/150/75 mg + ASA|Patients randomized to the Clopidogrel 600/150/75 mg dose regimen irrespective of the ASA dose
1186615|NCT00335452|O1|Outcome|Clopidogrel 300/75/75 mg + ASA|Patients randomized to the Clopidogrel 300/75/75 mg dose regimen irrespective of the ASA dose
1186616|NCT00335452|E4|Reported Event|Clopidogrel 600/150/75 mg + ASA High Dose|"Day 1: Clopidogrel 600 mg loading dose + ASA ≥ 300 mg~Day 2 to Day 7: Clopidogrel 150 mg + ASA 300-325 mg~Day 8 to Day 30: Clopidogrel 75 mg + ASA 300-325 mg"
1186617|NCT00335452|E3|Reported Event|Clopidogrel 600/150/75 mg + ASA Low Dose|"Day 1: Clopidogrel 600 mg loading dose + ASA ≥ 300 mg~Day 2 to Day 7: Clopidogrel 150 mg + ASA 75-100 mg~Day 8 to Day 30: Clopidogrel 75 mg + ASA 75-100 mg"
1186618|NCT00335452|E2|Reported Event|Clopidogrel 300/75/75 mg + ASA High Dose|"Day 1: Clopidogrel 300 mg loading dose + ASA ≥ 300 mg~Day 2 to Day 7: Clopidogrel 75 mg + ASA 300-325 mg~Day 8 to Day 30: Clopidogrel 75 mg + ASA 300-325 mg"
1186619|NCT00335452|E1|Reported Event|Clopidogrel 300/75/75 mg + ASA Low Dose|"Day 1: Clopidogrel 300 mg loading dose + ASA ≥ 300 mg~Day 2 to Day 7: Clopidogrel 75 mg + ASA 75-100 mg~Day 8 to Day 30: Clopidogrel 75 mg + ASA 75-100 mg"
1186620|NCT00335322|B4|Baseline|Total|Total of all reporting groups
1186621|NCT00335322|B3|Baseline|TDF/FTC+AZT+ABC|Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)
1186622|NCT00335322|B2|Baseline|TDF/FTC+r/ATV|Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV)
1186623|NCT00335322|B1|Baseline|TDF/FTC+EFV|
1186624|NCT00335322|P3|Participant Flow|TDF/FTC+AZT+ABC|Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)
1186625|NCT00335322|P2|Participant Flow|TDF/FTC+r/ATV|Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV)
1186626|NCT00335322|P1|Participant Flow|TDF/FTC+EFV|
1186627|NCT00335322|O3|Outcome|TDF/FTC+AZT+ABC|
1186628|NCT00335322|O2|Outcome|TDF/FTC+r/ATV|
1186629|NCT00335322|O1|Outcome|TDF/FTC+EFV|
1186630|NCT00335322|E3|Reported Event|TDF/FTC+AZT+ABC|Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)
1186631|NCT00335322|E2|Reported Event|TDF/FTC+r/ATV|Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV)
1186632|NCT00335322|E1|Reported Event|TDF/FTC+EFV|
1186633|NCT00335283|B3|Baseline|Total|Total of all reporting groups
1186634|NCT00335283|B2|Baseline|Placebo (Sugar Pill)|one tablet twice a day
1186635|NCT00335283|B1|Baseline|Lansoprazole|40 mg twice a day
1186636|NCT00335283|P2|Participant Flow|Placebo (Sugar Pill)|one tablet twice a day
1186637|NCT00335283|P1|Participant Flow|Lansoprazole|40 mg twice a day
1186638|NCT00335283|O2|Outcome|Placebo (Sugar Pill)|one tablet twice a day
1186639|NCT00335283|O1|Outcome|Lansoprazole|40 mg twice a day
1186640|NCT00335283|O2|Outcome|Placebo (Sugar Pill)|one tablet twice a day
1186641|NCT00335283|O1|Outcome|Lansoprazole|40 mg twice a day
1186642|NCT00335283|O2|Outcome|Placebo (Sugar Pill)|one tablet twice a day
1186643|NCT00335283|O1|Outcome|Lansoprazole|40 mg twice a day
1186644|NCT00335283|O2|Outcome|Placebo (Sugar Pill)|one tablet twice a day
1186645|NCT00335283|O1|Outcome|Lansoprazole|40 mg twice a day
1186646|NCT00335283|E2|Reported Event|Placebo (Sugar Pill)|one tablet twice a day
1186647|NCT00335283|E1|Reported Event|Lansoprazole|40 mg twice a day
1186648|NCT00335257|B4|Baseline|Total|Total of all reporting groups
1186649|NCT00335257|B3|Baseline|OCs Non-DRSP|Users of OCs containing other progestins
1186650|NCT00335257|B2|Baseline|OC DRSP-21d|OCs containing DRSP (Yasmin®, 21 day regimen)
1186651|NCT00335257|B1|Baseline|OC DRSP-24d|OCs containing DRSP (Yaz®, 24 day regimen )
1186652|NCT00335257|P3|Participant Flow|OCs Non-DRSP|Users of OCs containing other progestins
1186653|NCT00335257|P2|Participant Flow|OC DRSP-21d|OCs containing DRSP (Yasmin®, 21 day regimen)
1186654|NCT00335257|P1|Participant Flow|OC DRSP-24d|OCs containing DRSP (Yaz®, 24 day regimen)
1186655|NCT00335257|O5|Outcome|No Use|No (hormonal) contraception
1186656|NCT00335257|O4|Outcome|NOHC|Non-oral hormonal contraception (injections, implants, levonorgestrel-containing IUDs, or contraceptive patches)
1186657|NCT00335257|O3|Outcome|OCs Non-DRSP|Users of OCs containing other progestins
1186658|NCT00335257|O2|Outcome|OC DRSP-21d|21-day regimen of DRSP/EE
1186659|NCT00335257|O1|Outcome|OC DRSP-24d|24-day regimen of DRSP/EE
1186660|NCT00335257|O5|Outcome|No Use|No (hormonal) contraception at last contact
1186661|NCT00335257|O4|Outcome|NOHC|Non-oral hormonal contraception (injections, implants, levonorgestrel-containing IUDs, or contraceptive patches)
1186662|NCT00335257|O3|Outcome|OCs Non-DRSP|Users of OCs containing other progestins than DRSP
1186663|NCT00335257|O2|Outcome|OC DRSP-21d|21-day regimen of DRSP/EE
1186664|NCT00335257|O1|Outcome|OC DRSP-24d|24-day regimen of DRSP/EE
1186665|NCT00335257|E5|Reported Event|No Use|No (hormonal) contraception)
1186666|NCT00335257|E4|Reported Event|NOHC|Non-oral hormonal contraception (injections, implants, levonorgestrel-containing IUDs, or patches)
1186667|NCT00335257|E3|Reported Event|OCs Non-DRSP|Users of OCs containing other progestins
1186668|NCT00335257|E2|Reported Event|DRSP-21d|21-day regimen of DRSP/EE
1186669|NCT00335257|E1|Reported Event|DRSP-24d|24-day regimen of DRSP/EE
1186758|NCT00334802|O1|Outcome|Dose Level 1|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
1187317|NCT00332605|P1|Participant Flow|Naltrexone|Naltrexone tablets - 50mg pills taken by mouth daily
1186670|NCT00335153|B1|Baseline|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186671|NCT00335153|P1|Participant Flow|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive levodopa-carbidopa intestinal gel (LCIG), via the nasojejunal (NJ) tube during the NJ Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186672|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186673|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186674|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186675|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186676|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186677|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186678|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186711|NCT00334958|P1|Participant Flow|Rufinamide|For the 12-day Titration Phase, rufinamide was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
1195572|NCT00313144|O4|Outcome|>12 Months to ≤18 Months|
1186759|NCT00334802|O2|Outcome|Dose Level 2|Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
1186760|NCT00334802|O1|Outcome|Dose Level 1|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
1186679|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186680|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186681|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186682|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186683|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186684|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186685|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186686|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186687|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186688|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186729|NCT00334893|E2|Reported Event|Platinum-Sensitive Disease|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~eribulin mesylate : Given IV"
1186730|NCT00334893|E1|Reported Event|Platinum-Resistant Disease|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~eribulin mesylate : Given IV"
1186689|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186690|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186691|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186692|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186693|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186694|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186695|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186696|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186697|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186698|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186731|NCT00334815|B3|Baseline|Total|Total of all reporting groups
1186732|NCT00334815|B2|Baseline|High Risk Patient Stratum|
1186733|NCT00334815|B1|Baseline|Low Risk Patient Stratum|
1186756|NCT00334802|O1|Outcome|Gemcitabine + Paclitaxcel|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 Paclitaxcel: 175 mg/m2, intravenous (IV), day 1
1186699|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186700|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186701|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186702|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186703|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186704|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186705|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186706|NCT00335153|E1|Reported Event|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
1186707|NCT00334958|B3|Baseline|Total|Total of all reporting groups
1186708|NCT00334958|B2|Baseline|Placebo|For the 12-day Titration Phase, placebo was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day).
1186709|NCT00334958|B1|Baseline|Rufinamide|For the 12-day Titration Phase, rufinamide was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
1186710|NCT00334958|P2|Participant Flow|Placebo|For the 12-day Titration Phase, placebo was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day).
1186814|NCT00334282|O2|Outcome|Placebo|Matching Placebo administered once a day
1186712|NCT00334958|O2|Outcome|Placebo|For the 12-day Titration Phase, placebo was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day).
1186713|NCT00334958|O1|Outcome|Rufinamide|For the 12-day Titration Phase, rufinamide was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
1186714|NCT00334958|O2|Outcome|Placebo|For the 12-day Titration Phase, placebo was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day).
1186715|NCT00334958|O1|Outcome|Rufinamide|For the 12-day Titration Phase, rufinamide was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
1186716|NCT00334958|O2|Outcome|Placebo|For the 12-day Titration Phase, placebo was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day).
1186717|NCT00334958|O1|Outcome|Rufinamide|For the 12-day Titration Phase, rufinamide was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
1186718|NCT00334958|O2|Outcome|Placebo|For the 12-day Titration Phase, placebo was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day).
1186719|NCT00334958|O1|Outcome|Rufinamide|For the 12-day Titration Phase, rufinamide was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
1186720|NCT00334958|E2|Reported Event|Placebo|For the 12-day Titration Phase, placebo was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day).
1186721|NCT00334958|E1|Reported Event|Rufinamide|For the 12-day Titration Phase, rufinamide was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
1186722|NCT00334893|B3|Baseline|Total|Total of all reporting groups
1186723|NCT00334893|B2|Baseline|Platinum-Sensitive Cohort|Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1186724|NCT00334893|B1|Baseline|Platinum-Resistant Cohort|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~eribulin mesylate : Given IV"
1186725|NCT00334893|P2|Participant Flow|Platinum Sensitive Cohort|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~eribulin mesylate : Given IV"
1186726|NCT00334893|P1|Participant Flow|Platinum Resistant Cohort|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~eribulin mesylate : Given IV"
1186727|NCT00334893|O2|Outcome|Platinum-Sensitive Disease|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~eribulin mesylate : Given IV"
1186728|NCT00334893|O1|Outcome|Platinum-Resistant Disease|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~eribulin mesylate : Given IV"
1186757|NCT00334802|O2|Outcome|Dose Level 2|Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
1186734|NCT00334815|P2|Participant Flow|High Risk Patient Stratum|"Patients with at least one of the following characteristics: squamous histology, a primary tumor with cavitation or within 1 cm of a major blood vessel, a history of hemoptysis.~Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.~cisplatin: Given IV~etoposide: Given IV~radiation therapy: Undergo thoracic radiotherapy~docetaxel: Given IV~filgrastim: Given SC~pegfilgrastim: Given SC"
1186735|NCT00334815|P1|Participant Flow|Low Risk Patient Stratum|"Patients with non-squamous histology, a primary tumor with no cavitation and not within 1 cm of a major blood vessel, and no history of hemoptysis.~Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.~cisplatin: Given IV~etoposide: Given IV~radiation therapy: Undergo thoracic radiotherapy~docetaxel: Given IV~filgrastim: Given SC~pegfilgrastim: Given SC"
1186736|NCT00334815|O2|Outcome|High Risk Patient Stratum|"Patients with at least one of the following characteristics: squamous histology, a primary tumor with cavitation or within 1 cm of a major blood vessel, a history of hemoptysis.~Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.~cisplatin: Given IV~etoposide: Given IV~radiation therapy: Undergo thoracic radiotherapy~docetaxel: Given IV~filgrastim: Given SC~pegfilgrastim: Given SC"
1186737|NCT00334815|O1|Outcome|Low Risk Patient Stratum|"Patients with non-squamous histology, a primary tumor with no cavitation and not within 1 cm of a major blood vessel, and no history of hemoptysis.~Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.~cisplatin: Given IV~etoposide: Given IV~radiation therapy: Undergo thoracic radiotherapy~docetaxel: Given IV~filgrastim: Given SC~pegfilgrastim: Given SC"
1186738|NCT00334815|O2|Outcome|High Risk Patient Stratum|"Patients with at least one of the following characteristics: squamous histology, a primary tumor with cavitation or within 1 cm of a major blood vessel, a history of hemoptysis.~Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.~cisplatin: Given IV~etoposide: Given IV~radiation therapy: Undergo thoracic radiotherapy~docetaxel: Given IV~filgrastim: Given SC~pegfilgrastim: Given SC"
1186739|NCT00334815|O1|Outcome|Low Risk Patient Stratum|"Patients with non-squamous histology, a primary tumor with no cavitation and not within 1 cm of a major blood vessel, and no history of hemoptysis.~Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.~cisplatin: Given IV~etoposide: Given IV~radiation therapy: Undergo thoracic radiotherapy~docetaxel: Given IV~filgrastim: Given SC~pegfilgrastim: Given SC"
1186740|NCT00334815|O2|Outcome|High Risk Patient Stratum|"Patients with at least one of the following characteristics: squamous histology, a primary tumor with cavitation or within 1 cm of a major blood vessel, a history of hemoptysis.~Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.~cisplatin: Given IV~etoposide: Given IV~radiation therapy: Undergo thoracic radiotherapy~docetaxel: Given IV~filgrastim: Given SC~pegfilgrastim: Given SC"
1186741|NCT00334815|O1|Outcome|Low Risk Patient Stratum|"Patients with non-squamous histology, a primary tumor with no cavitation and not within 1 cm of a major blood vessel, and no history of hemoptysis.~Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.~cisplatin: Given IV~etoposide: Given IV~radiation therapy: Undergo thoracic radiotherapy~docetaxel: Given IV~filgrastim: Given SC~pegfilgrastim: Given SC"
1186742|NCT00334815|O2|Outcome|Consolidation Therapy With Docetaxel and Bevacizumab.|
1186743|NCT00334815|O1|Outcome|Concurrent Chemotherapy and Radiotherapy|
1186744|NCT00334815|E2|Reported Event|Consolidation Therapy With Docetaxel and Bevacizumab|All eligible patients, both low-risk and high-risk strata combined, who received consolidation therapy with Docetaxel and Bevacizumab.
1186745|NCT00334815|E1|Reported Event|Concurrent Chemotherapy and Radiotherapy|All eligible patients, both low-risk and high-risk strata combined, who received concurrent chemotherapy and radiotherapy.
1186746|NCT00334802|B3|Baseline|Total|Total of all reporting groups
1186747|NCT00334802|B2|Baseline|Dose Level 2|Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
1186748|NCT00334802|B1|Baseline|Dose Level 1|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
1186749|NCT00334802|P2|Participant Flow|Dose Level 2|Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
1186750|NCT00334802|P1|Participant Flow|Dose Level 1|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
1186751|NCT00334802|O2|Outcome|Gemcitabine|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8
1186752|NCT00334802|O1|Outcome|Gemcitabine + Paclitaxcel|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 Paclitaxcel: 175 mg/m2, intravenous (IV), day 1
1186753|NCT00334802|O2|Outcome|Gemcitabine|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8
1186754|NCT00334802|O1|Outcome|Gemcitabine + Paclitaxcel|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 Paclitaxcel: 175 mg/m2, intravenous (IV), day 1
1186755|NCT00334802|O2|Outcome|Gemcitabine|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8
1186811|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
1186761|NCT00334802|O1|Outcome|Dose Level 2|Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
1186762|NCT00334802|O2|Outcome|Dose Level 2|Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
1186763|NCT00334802|O1|Outcome|Dose Level 1|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
1186764|NCT00334802|E2|Reported Event|Dose Level 2|Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
1186765|NCT00334802|E1|Reported Event|Dose Level 1|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
1186766|NCT00334633|B4|Baseline|Total|Total of all reporting groups
1186767|NCT00334633|B3|Baseline|Tinidazole 1 gm|tinidazole 1 gm BID for 7 days; 196 particpants
1186768|NCT00334633|B2|Baseline|Tinidazole 500 mg|tinidazole 500 BID for 7 days; 200 particpants
1186769|NCT00334633|B1|Baseline|Metronidazole|metronidazole 500 BID for 7 days; 197 participants
1186770|NCT00334633|P3|Participant Flow|Tinidazole 1 gm|tinidazole 1 gm BID for 7 days; 196 particpants
1186771|NCT00334633|P2|Participant Flow|Tinidazole 500 mg|tinidazole 500 BID for 7 days; 200 particpants
1186772|NCT00334633|P1|Participant Flow|Metronidazole|metronidazole 500 twice a day (BID) for 7 days; 197 participants
1186773|NCT00334633|O3|Outcome|Tinidazole 1 gm|tinidazole 1 gm BID for 7 days; 196 particpants
1186774|NCT00334633|O2|Outcome|Tinidazole 500 mg|tinidazole 500 BID for 7 days; 200 particpants
1186775|NCT00334633|O1|Outcome|Metronidazole|metronidazole 500 BID for 7 days; 197 participants
1186776|NCT00334633|E3|Reported Event|Tinidazole 1 gm|tinidazole 1 gm BID for 7 days; 196 particpants
1186777|NCT00334633|E2|Reported Event|Tinidazole 500 mg|tinidazole 500 BID for 7 days; 200 particpants
1186778|NCT00334633|E1|Reported Event|Metronidazole|metronidazole 500 BID for 7 days; 197 participants
1186779|NCT00334542|B1|Baseline|Simvastatin|Simvastatin 40 mg for 24-28 weeks
1186780|NCT00334542|P1|Participant Flow|Simvastatin|Simvastatin 40 mg for 24-28 weeks
1186781|NCT00334542|O1|Outcome|Simvastatin|Simvastatin 40 mg for 24-28 weeks
1186782|NCT00334542|O1|Outcome|Simvastatin|Simvastatin 40 mg for 24-28 weeks
1186783|NCT00334542|E1|Reported Event|Simvastatin|Simvastatin 40 mg for 24-28 weeks
1186784|NCT00334295|B1|Baseline|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
1186785|NCT00334295|P1|Participant Flow|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
1186786|NCT00334295|O1|Outcome|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
1186787|NCT00334295|O1|Outcome|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
1186788|NCT00334295|O1|Outcome|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
1186789|NCT00334295|O1|Outcome|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
1186790|NCT00334295|O1|Outcome|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
1186791|NCT00334295|E1|Reported Event|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
1186792|NCT00334282|B3|Baseline|Total|Total of all reporting groups
1186793|NCT00334282|B2|Baseline|Placebo|Matching Placebo administered once a day
1186794|NCT00334282|B1|Baseline|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
1186795|NCT00334282|P2|Participant Flow|Placebo|Matching Placebo administered orally once a day
1186796|NCT00334282|P1|Participant Flow|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
1186797|NCT00334282|O2|Outcome|Placebo|Matching placebo administered orally once a day
1186798|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
1186799|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered once daily
1186800|NCT00334282|O2|Outcome|Placebo|Matching placebo administered orally once a day
1186801|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
1186802|NCT00334282|O2|Outcome|Placebo|Matching placebo administered orally once a day
1186803|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
1186804|NCT00334282|O2|Outcome|Placebo|Matching placebo administered orally once a day
1186805|NCT00334282|O1|Outcome|Pazopanib|Pazopanib 800 mg (tablets) administered orally once a day
1186806|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
1186807|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
1186808|NCT00334282|O2|Outcome|Placebo|Matching placebo administered orally once a day
1186809|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
1186810|NCT00334282|O2|Outcome|Placebo|Matching Placebo administered orally once a day
1186815|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
1186816|NCT00334282|E2|Reported Event|Placebo|Matching Placebo administered orally once a day
1186817|NCT00334282|E1|Reported Event|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
1186818|NCT00334204|B1|Baseline|Measure PFA-100|measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
1186853|NCT00333983|P1|Participant Flow|Planar Robot|Robot-assisted planar reaching x 60 minutes
1186819|NCT00334204|P1|Participant Flow|Measure PFA-100|measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
1186820|NCT00334204|O1|Outcome|Measure Platelet Function Analyser-100 (PFA-100)|measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
1186821|NCT00334204|O1|Outcome|Measure Platelet Function Analyser-100 (PFA-100)|measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
1186822|NCT00334204|O1|Outcome|Measure PFA-100|measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
1186823|NCT00334204|E1|Reported Event|Measure PFA-100|measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
1186824|NCT00334113|B3|Baseline|Total|Total of all reporting groups
1186825|NCT00334113|B2|Baseline|Treatment as Usual|"This is the treatment as usual condition. Participants in this condition will also have 2 sessions with an exercise physiologist and will receive an exercise prescription for a home based walking program. The will not receive the automated phone calls each week that are designed to motivate physical activity."
1186826|NCT00334113|B1|Baseline|TLC-PED|"Participants in this arm will meet with an exercise physiologist and obtain an exercise prescription for a walking program. In addition, they will be called every week by an automated telephone system that is designed to motivate individuals with type 2 diabetes to participate in regular physical activity.~Motivate physical activity in diabetic individuals.: Telephone-Linked Care - Promoting Exercise for Diabetes (TLC-PED), a method that uses interactive voice response and speech recognition technologies, will be developed to provide individualized and personalized motivational messages using automated telephone calls for veterans with Type 2 diabetes who participate in a home based walking program."
1186827|NCT00334113|P2|Participant Flow|Treatment as Usual|"This is the treatment as usual condition. Participants in this condition will also have 2 sessions with an exercise physiologist and will receive an exercise prescription for a home based walking program. The will not receive the automated phone calls each week that are designed to motivate physical activity."
1186828|NCT00334113|P1|Participant Flow|TLC-PED|"Participants in this arm will meet with an exercise physiologist and obtain an exercise prescription for a walking program. In addition, they will be called every week by an automated telephone system that is designed to motivate individuals with type 2 diabetes to participate in regular physical activity.~Motivate physical activity in diabetic individuals.: Telephone-Linked Care - Promoting Exercise for Diabetes (TLC-PED), a method that uses interactive voice response and speech recognition technologies, will be developed to provide individualized and personalized motivational messages using automated telephone calls for veterans with Type 2 diabetes who participate in a home based walking program."
1186829|NCT00334113|O2|Outcome|Treatment as Usual|"This is the treatment as usual condition. Participants in this condition will also have 2 sessions with an exercise physiologist and will receive an exercise prescription for a home based walking program. The will not receive the automated phone calls each week that are designed to motivate physical activity."
1186830|NCT00334113|O1|Outcome|TLC-PED|Participants in this arm will meet with an exercise physiologist and obtain an exercise prescription for a walking program. In addition, they will be called every week by an automated telephone system that is designed to motivate individuals with type 2 diabetes to participate in regular physical activity.
1186831|NCT00334113|E2|Reported Event|Treatment as Usual|"This is the treatment as usual condition. Participants in this condition will also have 2 sessions with an exercise physiologist and will receive an exercise prescription for a home based walking program. The will not receive the automated phone calls each week that are designed to motivate physical activity."
1186832|NCT00334113|E1|Reported Event|TLC-PED|Participants in this arm will meet with an exercise physiologist and obtain an exercise prescription for a walking program. In addition, they will be called every week by an automated telephone system that is designed to motivate individuals with type 2 diabetes to participate in regular physical activity.
1186833|NCT00334074|B1|Baseline|Clofarabine and Cytarabine|Clofarabine 40 mg/m2 IV infusion over 1 hour for 5 days; Cytarabine 1000 mg/m2 IV infusion 4 hours post clofarabine IVI.
1186834|NCT00334074|P1|Participant Flow|Clofarabine and Cytarabine|5 consecutive days of Clofarabine 40 mg/m^2 intravenous infusion over 1 hour followed 4 hours later by cytarabine 1000mg/m^2 intravenous infusion over 2 hours.Next cycle will start approximately 4 weeks after Day 1 of previous cycle. Patients will receive a maximum of 4 cycles of study treatment.
1186835|NCT00334074|O1|Outcome|Clofarabine and Cytarabine|Clofarabine 40 mg/m2 IV infusion over 1 hour for 5 days; Cytarabine 1000 mg/m2 IV infusion 4 hours post clofarabine IVI.
1186836|NCT00334074|O1|Outcome|Clofarabine Plus Cytarabine|Clofarabine 40 mg/m2 IV infusion over 1 hour for 5 days; Four hours post clofarabine infusion,Give cytarabine 1000 mg/m2 IV infusion over 2 hours.Patients will receive a maximum upto 4 cycles of study treatment.Next cycle will start approximately 4 weeks after Day 1 of previous cycle.
1186837|NCT00334074|E1|Reported Event|Clofarabine and Cytarabine|Clofarabine 40 mg/m2 intravenous infusion over 1 hour for 5 days; Cytarabine 1000 mg/m2 intravenous infusion 4 hours post clofarabine IVI.
1186838|NCT00334061|B1|Baseline|Penumbra System|
1186839|NCT00334061|P1|Participant Flow|Penumbra System|
1186840|NCT00334061|O1|Outcome|Penumbra System|
1186841|NCT00334061|O1|Outcome|Penumbra System|
1186842|NCT00334061|O1|Outcome|Penumbra System|
1186843|NCT00334061|O1|Outcome|Penumbra System|
1186844|NCT00334061|O1|Outcome|Penumbra System|
1186845|NCT00334061|O1|Outcome|Penumbra System|
1186846|NCT00334061|E1|Reported Event|Penumbra System|
1186847|NCT00333983|B4|Baseline|Total|Total of all reporting groups
1186848|NCT00333983|B3|Baseline|Intensive Conventional Exercise|Upper extremity stretching, skateboard reaching activities, range of motion, and arm ergometer training x 60 minutes.
1186849|NCT00333983|B2|Baseline|Planar + Vertical Robot|Robot-assisted planar and robot-assisted vertical reaching x 60 minutes.
1186850|NCT00333983|B1|Baseline|Planar Robot|Robot-assisted planar reaching x 60 minutes.
1186851|NCT00333983|P3|Participant Flow|Intensive Conventional Exercise|Upper extremity stretching, skateboard reaching activites, range of motion and arm ergometer x 60 minutes.
1186852|NCT00333983|P2|Participant Flow|Planar + Vertical Robot|Robot-assisted planar and robot-assisted vertical reaching x 60 minutes
1186854|NCT00333983|O3|Outcome|Intensive Conventional Exercise|Upper extremity stretching, skateboard reaching activities, range of motion, and arm ergometer training x 60 minutes.
1186855|NCT00333983|O2|Outcome|Planar + Vertical|Planar + Vertical Robot Exercise x 60 minutes.
1186856|NCT00333983|O1|Outcome|Planar Robot|Planar Robot Exercise x 60 minutes.
1186857|NCT00333983|E3|Reported Event|Intensive Conventional Exercise|Upper extremity stretching, skateboard reaching activities, range of motion and arm ergometer training.
1186858|NCT00333983|E2|Reported Event|Planar + Vertical Robot|Planar + Vertical Robot Exercise Group
1186859|NCT00333983|E1|Reported Event|Planar Robot|Planar Robot Exercise Group
1186860|NCT00333970|B3|Baseline|Total|Total of all reporting groups
1186861|NCT00333970|B2|Baseline|Arm 2|treatment as usual
1186862|NCT00333970|B1|Baseline|Arm 1|"cognitive remediation~cognitive remediation: individual cognitive training"
1186863|NCT00333970|P2|Participant Flow|Arm 2|treatment as usual
1186864|NCT00333970|P1|Participant Flow|Arm 1|"cognitive remediation~cognitive remediation: individual cognitive training"
1186865|NCT00333970|O2|Outcome|Arm 2|treatment as usual
1186866|NCT00333970|O1|Outcome|Arm 1|"cognitive remediation~cognitive remediation: individual cognitive training"
1186867|NCT00333970|E2|Reported Event|Arm 2|treatment as usual
1186868|NCT00333970|E1|Reported Event|Arm 1|"cognitive remediation~cognitive remediation: individual cognitive training"
1186869|NCT00333879|B1|Baseline|Virtual Sound System|Efficacy of using a virtual sound system to simulate street crossing conditions.
1186870|NCT00333879|P1|Participant Flow|Virtual Sound System|Efficacy of using a virtual sound system to simulate street crossing conditions.
1186871|NCT00333879|O1|Outcome|Virtual Sound System|Efficacy of using a virtual sound system to simulate street crossing conditions.
1186872|NCT00333879|O1|Outcome|Virtual Sound System|Efficacy of using a virtual sound system to simulate street crossing conditions.
1186873|NCT00333879|E1|Reported Event|Virtual Sound System|Efficacy of using a virtual sound system to simulate street crossing conditions.
1186874|NCT00333866|B5|Baseline|Total|Total of all reporting groups
1186875|NCT00333866|B4|Baseline|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
1186876|NCT00333866|B3|Baseline|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
1186877|NCT00333866|B2|Baseline|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
1186878|NCT00333866|B1|Baseline|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
1186879|NCT00333866|P4|Participant Flow|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
1186880|NCT00333866|P3|Participant Flow|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
1186881|NCT00333866|P2|Participant Flow|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
1186882|NCT00333866|P1|Participant Flow|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
1186883|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
1186884|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
1186885|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
1186886|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
1186887|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
1186888|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
1186889|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
1186890|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
1186891|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
1186892|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
1186893|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
1186894|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
1186895|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
1186896|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
1186897|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
1186898|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
1186899|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
1186900|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
1186901|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
1186902|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
1186903|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
1186904|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
1186905|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
1186906|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
1186907|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
1186908|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
1186909|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
1186910|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
1186911|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
1186912|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
1186913|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
1186914|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
1186915|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
1186916|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
1186917|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
1186918|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
1187034|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
1186919|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
1186920|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
1186921|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
1186922|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
1186923|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
1186924|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
1186925|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
1186926|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
1186927|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
1186928|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
1186929|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
1186930|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
1186931|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
1186932|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
1186933|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
1186934|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
1186935|NCT00333866|E4|Reported Event|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
1186936|NCT00333866|E3|Reported Event|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
1186937|NCT00333866|E2|Reported Event|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
1186938|NCT00333866|E1|Reported Event|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
1186939|NCT00333840|B3|Baseline|Total|Total of all reporting groups
1186940|NCT00333840|B2|Baseline|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (CSI151). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
1186941|NCT00333840|B1|Baseline|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
1186942|NCT00333840|P4|Participant Flow|IFN-a + Ara-C to Imatinib|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571) 400 mg orally once daily in the morning.
1187035|NCT00333788|E1|Reported Event|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
1187036|NCT00333775|B4|Baseline|Total|Total of all reporting groups
1195573|NCT00313144|O3|Outcome|>6 Months to ≤12 Months|
1186943|NCT00333840|P3|Participant Flow|Imatinib to IFN-a + Ara-C|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month.
1186944|NCT00333840|P2|Participant Flow|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
1186945|NCT00333840|P1|Participant Flow|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
1186946|NCT00333840|O1|Outcome|IFN-a + Ara-C to Imatinib|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571) 400 mg orally once daily in the morning.
1186947|NCT00333840|O2|Outcome|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
1186948|NCT00333840|O1|Outcome|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
1186949|NCT00333840|O2|Outcome|IFN-a + Ara-C to Imatinib|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571) 400 mg orally once daily in the morning.
1186950|NCT00333840|O1|Outcome|Imatinib to IFN-a + Ara-C|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 mu/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injection for 10 days every month in the second-line treatment period.
1186951|NCT00333840|O2|Outcome|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
1186952|NCT00333840|O1|Outcome|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
1186953|NCT00333840|O2|Outcome|IFN-a + Ara-C to Imatinib|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571) 400 mg orally once daily in the morning.
1186954|NCT00333840|O1|Outcome|Imatinib to IFN-a + Ara-C|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month.
1186955|NCT00333840|O2|Outcome|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
1186956|NCT00333840|O1|Outcome|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
1186957|NCT00333840|O2|Outcome|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
1186958|NCT00333840|O1|Outcome|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C) in the second-line treatment period. Maximum study duration was 11.5 years.
1186959|NCT00333840|O2|Outcome|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
1186960|NCT00333840|O1|Outcome|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
1186961|NCT00333840|O2|Outcome|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (CSI151). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
1186962|NCT00333840|O1|Outcome|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
1186963|NCT00333840|O2|Outcome|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
1186964|NCT00333840|O1|Outcome|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
1186965|NCT00333840|E4|Reported Event|IFN-a + Ara-C to Imatinib|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571) 400 mg orally once daily in the morning.
1186966|NCT00333840|E3|Reported Event|Imatinib to IFN-a + Ara-C|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month.
1187037|NCT00333775|B3|Baseline|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
1187000|NCT00333801|O1|Outcome|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
1187144|NCT00333229|P2|Participant Flow|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
1186967|NCT00333840|E2|Reported Event|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
1186968|NCT00333840|E1|Reported Event|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C) in the second-line treatment period. Maximum study duration was 11.5 years.
1186969|NCT00333814|B4|Baseline|Total|Total of all reporting groups
1186970|NCT00333814|B3|Baseline|Sham|Sham
1186971|NCT00333814|B2|Baseline|Dexamethasone 700 µg|Dexamethasone 700 µg
1186972|NCT00333814|B1|Baseline|Dexamethasone 350 µg|Dexamethasone 350 µg
1186973|NCT00333814|P3|Participant Flow|Sham|Sham
1186974|NCT00333814|P2|Participant Flow|Dexamethasone 700 µg|Dexamethasone 700 µg
1186975|NCT00333814|P1|Participant Flow|Dexamethasone 350 µg|Dexamethasone 350 µg
1186976|NCT00333814|O3|Outcome|Sham|Sham
1186977|NCT00333814|O2|Outcome|Dexamethasone 700 µg|Dexamethasone 700 µg
1186978|NCT00333814|O1|Outcome|Dexamethasone 350 µg|Dexamethasone 350 µg
1186979|NCT00333814|O3|Outcome|Sham|Sham
1186980|NCT00333814|O2|Outcome|Dexamethasone 700 µg|Dexamethasone 700 µg
1186981|NCT00333814|O1|Outcome|Dexamethasone 350 µg|Dexamethasone 350 µg
1186982|NCT00333814|O3|Outcome|Sham|Sham
1186983|NCT00333814|O2|Outcome|Dexamethasone 700 µg|Dexamethasone 700 µg
1186984|NCT00333814|O1|Outcome|Dexamethasone 350 µg|Dexamethasone 350 µg
1186985|NCT00333814|E3|Reported Event|Sham|Sham
1186986|NCT00333814|E2|Reported Event|Dexamethasone 700 µg|Dexamethasone 700 µg
1186987|NCT00333814|E1|Reported Event|Dexamethasone 350 µg|Dexamethasone 350 µg
1186988|NCT00333801|B3|Baseline|Total|Total of all reporting groups
1186989|NCT00333801|B2|Baseline|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
1186990|NCT00333801|B1|Baseline|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
1186991|NCT00333801|P2|Participant Flow|Individual Placement and Support (IPS)|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
1186992|NCT00333801|P1|Participant Flow|Vocational Rehabilitation Program (VRP)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training , compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist
1186993|NCT00333801|O2|Outcome|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
1186994|NCT00333801|O1|Outcome|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
1186995|NCT00333801|O2|Outcome|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
1186996|NCT00333801|O1|Outcome|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
1186997|NCT00333801|O2|Outcome|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
1186998|NCT00333801|O1|Outcome|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
1186999|NCT00333801|O2|Outcome|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
1187309|NCT00332644|E2|Reported Event|Nicotine Lozenge|nicotine lozenge alone treatment
1187001|NCT00333801|O2|Outcome|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
1187002|NCT00333801|O1|Outcome|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
1187003|NCT00333801|O2|Outcome|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
1187004|NCT00333801|O1|Outcome|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
1187005|NCT00333801|O2|Outcome|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
1187006|NCT00333801|O1|Outcome|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
1187007|NCT00333801|E2|Reported Event|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
1187008|NCT00333801|E1|Reported Event|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
1187009|NCT00333788|B1|Baseline|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
1187010|NCT00333788|P1|Participant Flow|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
1187011|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
1187012|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
1187013|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
1187014|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
1187015|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
1187016|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
1187017|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
1187018|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
1187019|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
1187020|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
1187021|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
1187022|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
1187023|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
1187024|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
1187025|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
1187026|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
1187027|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
1187028|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
1187029|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
1187030|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
1187031|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
1187032|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
1187033|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
1187038|NCT00333775|B2|Baseline|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
1187318|NCT00332605|O3|Outcome|Placebo|Placebo capsules
1187039|NCT00333775|B1|Baseline|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
1187040|NCT00333775|P3|Participant Flow|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
1187041|NCT00333775|P2|Participant Flow|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
1187042|NCT00333775|P1|Participant Flow|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
1187043|NCT00333775|O3|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
1187044|NCT00333775|O2|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
1187045|NCT00333775|O1|Outcome|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
1187046|NCT00333775|O3|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
1187047|NCT00333775|O2|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
1187048|NCT00333775|O1|Outcome|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
1187049|NCT00333775|O3|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
1187050|NCT00333775|O2|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
1187051|NCT00333775|O1|Outcome|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
1187052|NCT00333775|O3|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
1187053|NCT00333775|O2|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
1187054|NCT00333775|O1|Outcome|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
1187055|NCT00333775|O3|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
1187056|NCT00333775|O2|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
1187085|NCT00333619|O2|Outcome|Active Control|Active control: Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).
1187057|NCT00333775|O1|Outcome|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
1187058|NCT00333775|E3|Reported Event|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
1187059|NCT00333775|E2|Reported Event|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
1187060|NCT00333775|E1|Reported Event|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
1187061|NCT00333762|B1|Baseline|Arm 1: SWCS and SPAM|"Subjects traversed a prescribed route using electric powered wheelchairs~Smart Wheelchair Component System (SWCS) :~Smart Power Assistance Module (SPAM) :"
1187062|NCT00333762|P1|Participant Flow|Arm 1: SWCS and SPAM|"Subjects traversed a prescribed route using electric powered wheelchairs~Smart Wheelchair Component System (SWCS) :~Smart Power Assistance Module (SPAM) :"
1187063|NCT00333762|O1|Outcome|Arm 1: SWCS and SPAM|"Subjects traversed a prescribed route using electric powered wheelchairs~Smart Wheelchair Component System (SWCS) :~Smart Power Assistance Module (SPAM) :"
1187064|NCT00333762|E1|Reported Event|Arm 1: SWCS and SPAM|"Subjects traversed a prescribed route using electric powered wheelchairs~Smart Wheelchair Component System (SWCS) :~Smart Power Assistance Module (SPAM) :"
1187065|NCT00333710|B4|Baseline|Total|Total of all reporting groups
1187066|NCT00333710|B3|Baseline|Control Condition/Treatment as Usual|"Control condition/treatment as usual.~No active treatment"
1187067|NCT00333710|B2|Baseline|Individual Telephone Contact|"Individual telephone contact treatment~Telehealth Intervention: Individual telephone contact with educational and goal setting components"
1187068|NCT00333710|B1|Baseline|Individual Face-to-face Contact|"Individual face-to-face contact treatment~Individual psychotherapy: Individual face-to-face contact with educational and goal setting components"
1187069|NCT00333710|P3|Participant Flow|Control Condition/Treatment as Usual|Control condition/treatment as usual
1187070|NCT00333710|P2|Participant Flow|Individual Telephone Contact|"Individual telephone contact treatment~Telehealth Intervention: Individual telephone contact with educational and goal setting components"
1187071|NCT00333710|P1|Participant Flow|Individual Face-to-face Contact|"Individual face-to-face contact treatment~Individual psychotherapy: Individual face-to-face contact with educational and goal setting components"
1187072|NCT00333710|O3|Outcome|Control Condition/Treatment as Usual|Control condition/treatment as usual
1187073|NCT00333710|O2|Outcome|Individual Telephone Contact|"Individual telephone contact treatment~Telehealth Intervention: Individual telephone contact with educational and goal setting components"
1187074|NCT00333710|O1|Outcome|Individual Face-to-face Contact|"Individual face-to-face contact treatment~Individual psychotherapy: Individual face-to-face contact with educational and goal setting components"
1187075|NCT00333710|E3|Reported Event|Control Condition/Treatment as Usual|Control condition/treatment as usual
1187076|NCT00333710|E2|Reported Event|Individual Telephone Contact|"Individual telephone contact treatment~Telehealth Intervention: Individual telephone contact with educational and goal setting components"
1187077|NCT00333710|E1|Reported Event|Individual Face-to-face Contact|"Individual face-to-face contact treatment~Individual psychotherapy: Individual face-to-face contact with educational and goal setting components"
1187078|NCT00333619|B3|Baseline|Total|Total of all reporting groups
1187079|NCT00333619|B2|Baseline|Active Control|"Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).~Active control: Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions)."
1187080|NCT00333619|B1|Baseline|Nonpharmacological Sleep Intervention|"The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies.~Nonpharmacological sleep intervention: The intervention combines: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies"
1187081|NCT00333619|P2|Participant Flow|Active Control|Active control: Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).
1187082|NCT00333619|P1|Participant Flow|Nonpharmacological Sleep Intervention|The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies.
1187083|NCT00333619|O2|Outcome|Active Control|"Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).~Active control: Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions)."
1187084|NCT00333619|O1|Outcome|Nonpharmacological Sleep Intervention|"The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies.~Nonpharmacological sleep intervention: The intervention combines: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies"
1187086|NCT00333619|O1|Outcome|Nonpharmacological Sleep Intervention|The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies.
1187087|NCT00333619|E2|Reported Event|Active Control|"Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).~Active control: Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions)."
1187088|NCT00333619|E1|Reported Event|Nonpharmacological Sleep Intervention|"The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies.~Nonpharmacological sleep intervention: The intervention combines: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies"
1187089|NCT00333437|B1|Baseline|Treatment|Study subjects receive standard mycophenolate dosing.
1187090|NCT00333437|P1|Participant Flow|Single-group Study Treatment|Study subjects receive standard mycophenolate dosing 2 grams/day.
1187091|NCT00333437|O1|Outcome|Treatment|Study subjects receive standard mycophenolate dosing.
1187092|NCT00333437|O1|Outcome|Treatment|Study subjects receive standard mycophenolate dosing.
1187093|NCT00333437|O1|Outcome|Treatment|Study subjects receive standard mycophenolate dosing.
1187094|NCT00333437|O1|Outcome|Treatment|Study subjects receive standard mycophenolate dosing 2 grams/day.
1187095|NCT00333437|O1|Outcome|Treatment|Study subjects receive standard mycophenolate dosing.
1187096|NCT00333437|E1|Reported Event|Treatment|Study subjects receive standard mycophenolate dosing.
1187097|NCT00333359|B3|Baseline|Total|Total of all reporting groups
1187098|NCT00333359|B2|Baseline|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187099|NCT00333359|B1|Baseline|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187100|NCT00333359|P2|Participant Flow|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187101|NCT00333359|P1|Participant Flow|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187102|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187103|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187104|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187105|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187106|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187107|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187108|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187109|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187110|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187111|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187112|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187113|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187114|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187142|NCT00333229|B2|Baseline|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
1187115|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187319|NCT00332605|O2|Outcome|N-Acetyl Cysteine|600mg tablets, daily
1187116|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187117|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187118|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187119|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187120|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187121|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187122|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187123|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187124|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187125|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187126|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187127|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187128|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187129|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187130|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187131|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187132|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187133|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187134|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187135|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187136|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187137|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187138|NCT00333359|E3|Reported Event|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187139|NCT00333359|E2|Reported Event|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187140|NCT00333359|E1|Reported Event|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
1187141|NCT00333229|B3|Baseline|Total|Total of all reporting groups
1187143|NCT00333229|B1|Baseline|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
1187145|NCT00333229|P1|Participant Flow|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
1187146|NCT00333229|O2|Outcome|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
1187147|NCT00333229|O1|Outcome|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
1187148|NCT00333229|O2|Outcome|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
1187149|NCT00333229|O1|Outcome|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
1187150|NCT00333229|O2|Outcome|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
1187151|NCT00333229|O1|Outcome|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
1187152|NCT00333229|O2|Outcome|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
1187153|NCT00333229|O1|Outcome|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
1187154|NCT00333229|O2|Outcome|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
1187155|NCT00333229|O1|Outcome|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
1187156|NCT00333229|E2|Reported Event|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
1187157|NCT00333229|E1|Reported Event|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
1187158|NCT00333138|B4|Baseline|Total|Total of all reporting groups
1187159|NCT00333138|B3|Baseline|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187160|NCT00333138|B2|Baseline|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187161|NCT00333138|B1|Baseline|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187162|NCT00333138|P3|Participant Flow|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187163|NCT00333138|P2|Participant Flow|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187164|NCT00333138|P1|Participant Flow|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187165|NCT00333138|O2|Outcome|FTY720 5.0 mg/Day|Patients randomized to fingolimod 5.0 mg/d in the core study who received fingolimod 5.0 mg/d in the dose-blind period of the extension study. All patients received fingolimod 1.25 mg/d initially in the open-label period and were later converted to fingolimod 0.5 mg/d.
1187166|NCT00333138|O1|Outcome|FTY720 1.25 mg/Day|Patients randomized to fingolimod 1.25 mg/d in the core study who received fingolimod 1.25 mg/d in the dose-blind period of the extension study and initially in the open-label period and were later converted to fingolimod 0.5 mg/d.
1187167|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187168|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187213|NCT00332839|O2|Outcome|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
1190795|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
1187169|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187170|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187171|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187172|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187173|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187174|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187175|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187176|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187177|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187178|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187179|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187180|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187181|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187182|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187183|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187184|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187185|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187186|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187187|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187306|NCT00332644|E5|Reported Event|Bupropion + Nicotine Lozenge|bupropion + nicotine lozenge combination treatment
1187188|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187320|NCT00332605|O1|Outcome|Naltrexone|Naltrexone tablets
1187189|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187190|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187191|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187192|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187193|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187194|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187195|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187196|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187197|NCT00333138|E3|Reported Event|Fingolimod (FTY720) 5.0 mg|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187198|NCT00333138|E2|Reported Event|Fingolimod (FTY720) 1.25 mg|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187199|NCT00333138|E1|Reported Event|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
1187200|NCT00332839|B3|Baseline|Total|Total of all reporting groups
1187201|NCT00332839|B2|Baseline|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
1187202|NCT00332839|B1|Baseline|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
1187203|NCT00332839|P2|Participant Flow|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
1187204|NCT00332839|P1|Participant Flow|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
1187205|NCT00332839|O2|Outcome|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
1187206|NCT00332839|O1|Outcome|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
1187207|NCT00332839|O2|Outcome|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
1187208|NCT00332839|O1|Outcome|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
1187209|NCT00332839|O2|Outcome|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
1187210|NCT00332839|O1|Outcome|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
1187211|NCT00332839|O2|Outcome|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
1187212|NCT00332839|O1|Outcome|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
1187307|NCT00332644|E4|Reported Event|Bupropion|bupropion alone treatment
1187214|NCT00332839|O1|Outcome|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
1187321|NCT00332605|E3|Reported Event|Placebo|
1187215|NCT00332839|O2|Outcome|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
1187216|NCT00332839|O1|Outcome|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
1187217|NCT00332839|O2|Outcome|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
1187218|NCT00332839|O1|Outcome|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
1187219|NCT00332839|E2|Reported Event|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
1187220|NCT00332839|E1|Reported Event|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
1187221|NCT00332722|B3|Baseline|Total|Total of all reporting groups
1187222|NCT00332722|B2|Baseline|Group 2 - With Steroid|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
1187223|NCT00332722|B1|Baseline|Group 1- Without Steroid|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
1187224|NCT00332722|P2|Participant Flow|Group 2 With Steroids|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
1187225|NCT00332722|P1|Participant Flow|Group 1 Without Steroids|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
1187226|NCT00332722|O2|Outcome|Group 2 - With Steroids|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
1187227|NCT00332722|O1|Outcome|Group 1 - Without Steroids|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
1187228|NCT00332722|O2|Outcome|Group 2 - With Steroids|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
1187229|NCT00332722|O1|Outcome|Group 1 - Without Steroids|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
1187230|NCT00332722|E2|Reported Event|Group 2 - With Steroid|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
1187231|NCT00332722|E1|Reported Event|Group 1- Without Steroid|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
1187232|NCT00332709|B3|Baseline|Total|Total of all reporting groups
1187233|NCT00332709|B2|Baseline|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
1187234|NCT00332709|B1|Baseline|Letrozole|Letrozole 2.5 mg/day for 3 years
1187235|NCT00332709|P2|Participant Flow|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
1187236|NCT00332709|P1|Participant Flow|Letrozole|Letrozole 2.5 mg/day for 3 years
1187237|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
1187238|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
1187239|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
1187240|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
1187241|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
1187242|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
1187243|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
1187244|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
1187245|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
1187246|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
1187247|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
1187248|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
1187249|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
1187250|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
1187251|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
1187252|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
1187253|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
1187254|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
1187255|NCT00332709|E2|Reported Event|Letrozole + Zolendronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
1187256|NCT00332709|E1|Reported Event|Letrozole|Letrozole orally 2.5 mg/day for 3 years
1187257|NCT00332696|B3|Baseline|Total|Total of all reporting groups
1187258|NCT00332696|B2|Baseline|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
1187308|NCT00332644|E3|Reported Event|Nicotine Patch + Lozenge|nicotine patch + lozenge combination treatment
1187310|NCT00332644|E1|Reported Event|Nicotine Patch|nicotine patch alone treatment for nicotine dependence.
1187311|NCT00332605|B4|Baseline|Total|Total of all reporting groups
1187312|NCT00332605|B3|Baseline|Placebo|
1187259|NCT00332696|B1|Baseline|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
1187260|NCT00332696|P2|Participant Flow|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
1187261|NCT00332696|P1|Participant Flow|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
1187262|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
1187263|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
1187264|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
1187265|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
1187266|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
1187267|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
1187268|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
1187269|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
1187270|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
1187271|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
1187272|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
1187273|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
1187274|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
1187275|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
1187276|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
1187277|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
1187278|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
1187279|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
1187280|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
1187281|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
1187282|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
1187283|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
1187284|NCT00332696|E2|Reported Event|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
1187285|NCT00332696|E1|Reported Event|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
1187286|NCT00332644|B7|Baseline|Total|Total of all reporting groups
1187287|NCT00332644|B6|Baseline|Placebo Control|placebo control (no active medication) treatment
1187288|NCT00332644|B5|Baseline|Bupropion + Nicotine Lozenge|bupropion + nicotine lozenge combination treatment
1187289|NCT00332644|B4|Baseline|Bupropion|bupropion alone treatment
1187290|NCT00332644|B3|Baseline|Nicotine Patch + Lozenge|nicotine patch + lozenge combination treatment
1187291|NCT00332644|B2|Baseline|Nicotine Lozenge|nicotine lozenge alone treatment
1187292|NCT00332644|B1|Baseline|Nicotine Patch|nicotine patch alone treatment for nicotine dependence.
1187293|NCT00332644|P6|Participant Flow|Placebo Control|placebo control (no active medication) treatment
1187294|NCT00332644|P5|Participant Flow|Bupropion + Nicotine Lozenge|bupropion + nicotine lozenge combination treatment
1187295|NCT00332644|P4|Participant Flow|Bupropion|bupropion alone treatment
1187296|NCT00332644|P3|Participant Flow|Nicotine Patch + Lozenge|nicotine patch + lozenge combination treatment
1187297|NCT00332644|P2|Participant Flow|Nicotine Lozenge|nicotine lozenge alone treatment
1187298|NCT00332644|P1|Participant Flow|Nicotine Patch|nicotine patch alone treatment for nicotine dependence.
1187299|NCT00332644|O6|Outcome|Placebo Control|placebo control (no active medication) treatment
1187300|NCT00332644|O5|Outcome|Bupropion + Nicotine Lozenge|bupropion + nicotine lozenge combination treatment
1187301|NCT00332644|O4|Outcome|Bupropion|bupropion alone treatment
1187302|NCT00332644|O3|Outcome|Nicotine Patch + Lozenge|nicotine patch + lozenge combination treatment
1187303|NCT00332644|O2|Outcome|Nicotine Lozenge|nicotine lozenge alone treatment
1187304|NCT00332644|O1|Outcome|Nicotine Patch|nicotine patch alone treatment for nicotine dependence.
1187305|NCT00332644|E6|Reported Event|Placebo Control|placebo control (no active medication) treatment
1187322|NCT00332605|E2|Reported Event|N-Acetyl Cysteine|600mg tablets taken by mouth daily
1187323|NCT00332605|E1|Reported Event|Naltrexone|Naltrexone tablets - 50mg pills taken by mouth daily
1187324|NCT00332579|B3|Baseline|Total|Total of all reporting groups
1187325|NCT00332579|B2|Baseline|Placebo|Placebo tablets (identical to naltrexone pills) taken by mouth daily.
1187326|NCT00332579|B1|Baseline|Naltrexone|Naltrexone 50mg tablets taken daily. Dose range from 50mg-150mg by mouth daily. Started at 50mg and then titrated up based upon investigator discretion.
1187327|NCT00332579|P2|Participant Flow|Placebo|Placebo tablets (identical to naltrexone pills) taken by mouth daily.
1187328|NCT00332579|P1|Participant Flow|Naltrexone|Naltrexone 50mg tablets taken daily. Dose range from 50mg-150mg by mouth daily. Started at 50mg and then titrated up based upon investigator discretion.
1187329|NCT00332579|O2|Outcome|Placebo|Placebo tablets (identical to naltrexone pills) taken by mouth daily.
1187330|NCT00332579|O1|Outcome|Naltrexone|Naltrexone 50mg tablets taken daily. Dose range from 50mg-150mg by mouth daily. Started at 50mg and then titrated up based upon investigator discretion.
1187331|NCT00332579|E2|Reported Event|Placebo|Placebo tablets (identical to naltrexone pills) taken by mouth daily.
1187332|NCT00332579|E1|Reported Event|Naltrexone|Naltrexone 50mg tablets taken daily. Dose range from 50mg-150mg by mouth daily. Started at 50mg and then titrated up based upon investigator discretion.
1187333|NCT00332488|B4|Baseline|Total|Total of all reporting groups
1187334|NCT00332488|B3|Baseline|TI Inhalation Powder + Metformin|
1187335|NCT00332488|B2|Baseline|Metformin & Secretagogues|
1187336|NCT00332488|B1|Baseline|TI Inhalation Powder Alone|
1187337|NCT00332488|P3|Participant Flow|TI Inhalation Powder + Metformin|Technosphere® Insulin Inhalation Powder administered prior to each meal (dose individualized for each subject) & Metformin (>= 1,000 mg/day or maximum tolerate dose)
1187338|NCT00332488|P2|Participant Flow|Metformin & Secretagogues|Metformin (>= 1,000 mg/day or maximum tolerate dose) & Secretagogue (Sulfonylurea or meglitinide at >= half maximum manufacturer recommended dose or maximum tolerated dose)
1187339|NCT00332488|P1|Participant Flow|TI Inhalation Powder Alone|Technosphere® Insulin Inhalation Powder administered prior to each meal without any other anti-diabetic treatment; dose individualized for each subject
1187340|NCT00332488|O3|Outcome|TI Inhalation Powder + Metformin|Technosphere® Insulin Inhalation Powder & Metformin
1187341|NCT00332488|O2|Outcome|Metformin & Secretagogues|Metformin & Secretagogues
1187342|NCT00332488|O1|Outcome|TI Inhalation Powder Alone|Technosphere® Insulin Inhalation Powder
1187343|NCT00332488|O2|Outcome|Metformin & Secretagogues|Metformin & Secretagogues
1187344|NCT00332488|O1|Outcome|TI Inhalation Powder Alone|Technosphere® Insulin Inhalation Powder
1187345|NCT00332488|O2|Outcome|TI Inhalation Powder + Metformin|Technosphere® Insulin Inhalation Powder & Metformin
1187346|NCT00332488|O1|Outcome|Metformin & Secretagogues|Metformin & Secretagogues
1187347|NCT00332488|E3|Reported Event|TI Inhalation Powder + Metformin|Technosphere® Insulin Inhalation Powder & Metformin
1187348|NCT00332488|E2|Reported Event|Metformin & Secretagogues|Metformin & Secretagogues
1187349|NCT00332488|E1|Reported Event|TI Inhalation Powder Alone|Technosphere® Insulin Inhalation Powder
1187350|NCT00332462|B1|Baseline|Cyclosporine (Sandimmun®)|Period 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days followed by Period 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
1187351|NCT00332462|P1|Participant Flow|Cyclosporine (Sandimmun®)|Period 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days followed by Period 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
1187352|NCT00332462|O2|Outcome|6 Months After Transplantation|
1187353|NCT00332462|O1|Outcome|3 Months After Transplantation|
1187354|NCT00332462|O1|Outcome|Cyclosporine (Sandimmun®)|Period 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days followed by Period 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
1187355|NCT00332462|E2|Reported Event|Cyclosporine (Sandimmun® Optoral)|Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
1187356|NCT00332462|E1|Reported Event|Cyclosporine (Sandimmun® i.v.)|Cyclosporine (Sandimmun®) intravenous (i.v) given 2 times daily as an infusion over a four hour period staring at a dose of 2 X 200 mg/day and continuing for 7 days. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
1187357|NCT00332332|B1|Baseline|Etanercept|Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
1195574|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
1187358|NCT00332332|P1|Participant Flow|Etanercept|Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
1187359|NCT00332332|O1|Outcome|Etanercept|Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
1187360|NCT00332332|O1|Outcome|Etanercept|Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
1187361|NCT00332332|O1|Outcome|Etanercept|Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
1187362|NCT00332332|O1|Outcome|Etanercept|Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
1187363|NCT00332332|E1|Reported Event|Etanercept|Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
1187364|NCT00332241|B3|Baseline|Total|Total of all reporting groups
1187365|NCT00332241|B2|Baseline|Aripiprazole|oral aripiprazole 2 to 15 mg QD
1187366|NCT00332241|B1|Baseline|Placebo|oral placebo once daily (QD)
1187367|NCT00332241|P2|Participant Flow|Aripiprazole|oral aripiprazole 2 to 15 mg QD
1187368|NCT00332241|P1|Participant Flow|Placebo|oral placebo once daily (QD)
1187369|NCT00332241|O2|Outcome|Aripiprazole|oral aripiprazole 2 to 15 mg QD
1187370|NCT00332241|O1|Outcome|Placebo|oral placebo once daily (QD)
1187371|NCT00332241|O2|Outcome|Aripiprazole|oral aripiprazole 2 to 15 mg QD
1187372|NCT00332241|O1|Outcome|Placebo|oral placebo once daily (QD)
1187373|NCT00332241|O2|Outcome|Aripiprazole|oral aripiprazole 2 to 15 mg QD
1187374|NCT00332241|O1|Outcome|Placebo|oral placebo once daily (QD)
1187375|NCT00332241|O2|Outcome|Aripiprazole|oral aripiprazole 2 to 15 mg QD
1187376|NCT00332241|O1|Outcome|Placebo|oral placebo once daily (QD)
1187377|NCT00332241|O2|Outcome|Aripiprazole|oral aripiprazole 2 to 15 mg QD
1187378|NCT00332241|O1|Outcome|Placebo|oral placebo once daily (QD)
1187379|NCT00332241|O2|Outcome|Aripiprazole|oral aripiprazole 2 to 15 mg QD
1187380|NCT00332241|O1|Outcome|Placebo|oral placebo once daily (QD)
1187381|NCT00332241|O2|Outcome|Aripiprazole|oral aripiprazole 2 to 15 mg QD
1187382|NCT00332241|O1|Outcome|Placebo|oral placebo once daily (QD)
1187383|NCT00332241|O2|Outcome|Aripiprazole|oral aripiprazole 2 to 15 mg QD
1187384|NCT00332241|O1|Outcome|Placebo|oral placebo once daily (QD)
1187385|NCT00332241|E2|Reported Event|Placebo|
1187386|NCT00332241|E1|Reported Event|Aripiprazole|
1187387|NCT00332189|B1|Baseline|Total Patient Population|The mean (+/- SD) daily dose of study drug was 16.4 (+/-4.4) mg/kg. The final dose prescribed was 20 mg/kg/day for 73 (65.8%) subjects, 10 mg/kg/day for 33 (29.7%) subjects, and 5 mg/kg/day for 5 (4.5%) subjects.
1187388|NCT00332189|P1|Participant Flow|Total Patient Population|Phenoptin will be taken orally once daily as the number of tablets equivalent to that of the last prescribed dose of the previous study (PKU-004 NCT00225615 or PKU-006 NCT00272792). Subjects who participated in PKU-006 NCT00272792 will receive Phenoptin as the number of tablets equivalent to 20 mg/kg/day at enrollment. The Phenoptin dose may be adjusted up or down as needed at the discretion of the investigator in increments of approximately 5 mg/kg/day within a range of 5 mg/kg/day to 20 mg/kg/day to control blood Phe to levels consistent with local clinical site recommendations for blood Phe control.
1187389|NCT00332189|O1|Outcome|Total Patient Population|The mean (+/- SD) daily dose of study drug was 16.4 (+/-4.4) mg/kg. The final dose prescribed was 20 mg/kg/day for 73 (65.8%) subjects, 10 mg/kg/day for 33 (29.7%) subjects, and 5 mg/kg/day for 5 (4.5%) subjects.
1187390|NCT00332189|O1|Outcome|Total Patient Population|The safety analysis population includes all subjects who received at least one dose of study drug during the study.
1187391|NCT00332189|E1|Reported Event|Total Patient Population|The mean (+/- SD) daily dose of study drug was 16.4 (+/-4.4) mg/kg. The final dose prescribed was 20 mg/kg/day for 73 (65.8%) subjects, 10 mg/kg/day for 33 (29.7%) subjects, and 5 mg/kg/day for 5 (4.5%) subjects.
1187392|NCT00332163|B3|Baseline|Total|Total of all reporting groups
1187393|NCT00332163|B2|Baseline|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
1187394|NCT00332163|B1|Baseline|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
1187395|NCT00332163|P2|Participant Flow|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
1187396|NCT00332163|P1|Participant Flow|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
1187397|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
1187451|NCT00331799|O1|Outcome|Duloxetine|Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg.
1187452|NCT00331799|E1|Reported Event|Open Label Treatment|Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg.
1187398|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
1187399|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
1187456|NCT00331773|P2|Participant Flow|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
1187535|NCT00330967|O1|Outcome|Group 2|"Femoral Intralipid infusion subjects~20% Intralipid: lipid infusion"
1187400|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
1187401|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
1187402|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
1187403|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
1187404|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
1187405|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
1187406|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
1187407|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
1187408|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
1187409|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
1187410|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
1187411|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
1187412|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
1187413|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
1187414|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
1187415|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
1187453|NCT00331773|B3|Baseline|Total|Total of all reporting groups
1187489|NCT00331760|E2|Reported Event|Cervical Cancer: IMRT + Chemotherapy (Cisplatin)|Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
1187416|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
1187417|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
1187418|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
1187419|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
1187420|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
1187421|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
1187422|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
1187423|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
1187424|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
1187425|NCT00332163|E2|Reported Event|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
1187426|NCT00332163|E1|Reported Event|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
1187427|NCT00331864|B3|Baseline|Total|Total of all reporting groups
1187428|NCT00331864|B2|Baseline|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
1187429|NCT00331864|B1|Baseline|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
1187430|NCT00331864|P2|Participant Flow|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
1187431|NCT00331864|P1|Participant Flow|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
1187432|NCT00331864|O2|Outcome|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
1187433|NCT00331864|O1|Outcome|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
1187488|NCT00331760|O1|Outcome|Endometrial Cancer: IMRT|Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
1187434|NCT00331864|O2|Outcome|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
1187457|NCT00331773|P1|Participant Flow|Conventional 3D-CRT|Conventional 3D-CRT or intensity-modulated radiotherapy (IMRT): Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
1187643|NCT00330460|O1|Outcome|Alendronate 70 mg QW|
1187435|NCT00331864|O1|Outcome|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
1187436|NCT00331864|O1|Outcome|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
1187437|NCT00331864|O2|Outcome|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
1187438|NCT00331864|O1|Outcome|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
1187439|NCT00331864|O2|Outcome|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
1187440|NCT00331864|O1|Outcome|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
1187441|NCT00331864|O2|Outcome|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
1187442|NCT00331864|O1|Outcome|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
1187443|NCT00331864|O2|Outcome|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
1187444|NCT00331864|O1|Outcome|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
1187445|NCT00331864|O2|Outcome|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
1187446|NCT00331864|O1|Outcome|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
1187447|NCT00331864|E2|Reported Event|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
1187448|NCT00331864|E1|Reported Event|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
1187449|NCT00331799|B1|Baseline|Open Label Treatment|Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg.
1187450|NCT00331799|P1|Participant Flow|Open Label Treatment With Duloxetine|Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg / day .
1187454|NCT00331773|B2|Baseline|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
1187455|NCT00331773|B1|Baseline|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
1187458|NCT00331773|O2|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
1187459|NCT00331773|O1|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
1187460|NCT00331773|O2|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
1187461|NCT00331773|O1|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
1187462|NCT00331773|O2|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
1187463|NCT00331773|O1|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
1187464|NCT00331773|O2|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
1187465|NCT00331773|O1|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
1187466|NCT00331773|O2|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
1187467|NCT00331773|O1|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
1187468|NCT00331773|O2|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
1187469|NCT00331773|O1|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
1187470|NCT00331773|O2|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
1187471|NCT00331773|O1|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
1187472|NCT00331773|O2|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
1187473|NCT00331773|O1|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
1187474|NCT00331773|O2|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
1187475|NCT00331773|O1|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
1187476|NCT00331773|O2|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
1187477|NCT00331773|O1|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
1187478|NCT00331773|O2|Outcome|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
1187479|NCT00331773|O1|Outcome|Conventional 3D-CRT|Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
1187480|NCT00331773|E2|Reported Event|Hypofractionated 3D-CRT|Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
1187481|NCT00331773|E1|Reported Event|Conventional 3D-CRT|CConventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
1187482|NCT00331760|B3|Baseline|Total|Total of all reporting groups
1187483|NCT00331760|B2|Baseline|Cervical Cancer: IMRT + Chemotherapy (Cisplatin)|Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
1187484|NCT00331760|B1|Baseline|Endometrial Cancer: IMRT|Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
1187485|NCT00331760|P2|Participant Flow|Cervical Cancer: IMRT + Chemotherapy (Cisplatin)|Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
1187486|NCT00331760|P1|Participant Flow|Endometrial Cancer: IMRT|Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
1187487|NCT00331760|O2|Outcome|Cervical Cancer: IMRT + Chemotherapy (Cisplatin)|Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
1195575|NCT00313144|O1|Outcome|Year Prior to Baseline|
1187490|NCT00331760|E1|Reported Event|Endometrial Cancer: IMRT|Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
1187491|NCT00331682|B1|Baseline|Docetaxel and Flavopiridol|"Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~flavopiridol: Given IV~docetaxel: Given IV"
1187492|NCT00331682|P1|Participant Flow|Docetaxel and Flavopiridol|"Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~alvocidib: Given IV~docetaxel: Given IV"
1187530|NCT00330967|O1|Outcome|Group 2|Femoral Intralipid infusion group
1187493|NCT00331682|O1|Outcome|Docetaxel and Flavopiridol|"Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~flavopiridol: Given IV~docetaxel: Given IV"
1187494|NCT00331682|O1|Outcome|Docetaxel and Flavopiridol|"Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~flavopiridol: Given IV~docetaxel: Given IV"
1187495|NCT00331682|O1|Outcome|Docetaxel and Flavopiridol|"Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~flavopiridol: Given IV~docetaxel: Given IV"
1187496|NCT00331682|E1|Reported Event|Docetaxel and Flavopiridol|"Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~flavopiridol: Given IV~docetaxel: Given IV"
1187497|NCT00331422|B1|Baseline|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
1187498|NCT00331422|P1|Participant Flow|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
1187499|NCT00331422|O1|Outcome|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
1187500|NCT00331422|O1|Outcome|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
1187501|NCT00331422|O1|Outcome|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
1187502|NCT00331422|O1|Outcome|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
1187503|NCT00331422|O1|Outcome|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
1187504|NCT00331422|O1|Outcome|Evaluable Patients (Received 4 Cycles of Therapy and Surgery)|Includes patients treated with 4 cycles of study chemotherapy regimen and surgery.
1187505|NCT00331422|E1|Reported Event|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
1187506|NCT00331409|B1|Baseline|Everolimus and Imatinib Mesylate|"Everolimus: 2.5 mg daily by mouth~Imatinib Mesylate: 600 mg daily by mouth"
1187507|NCT00331409|P1|Participant Flow|Everolimus and Imatinib Mesylate|"Everolimus: 2.5 mg daily by mouth~Imatinib Mesylate: 600 mg daily by mouth"
1187508|NCT00331409|O1|Outcome|Everolimus and Imatinib Mesylate|"Everolimus: 2.5 mg daily by mouth~Imatinib Mesylate: 600 mg daily by mouth"
1187509|NCT00331409|O1|Outcome|Everolimus and Imatinib Mesylate|"Everolimus: 2.5 mg daily by mouth~Imatinib Mesylate: 600 mg daily by mouth"
1187510|NCT00331409|O1|Outcome|Everolimus and Imatinib Mesylate|"Everolimus: 2.5 mg daily by mouth~Imatinib Mesylate: 600 mg daily by mouth"
1187511|NCT00331409|O1|Outcome|Everolimus and Imatinib Mesylate|"Everolimus: 2.5 mg daily by mouth~Imatinib Mesylate: 600 mg daily by mouth"
1187512|NCT00331409|E1|Reported Event|Everolimus and Imatinib Mesylate|"Everolimus: 2.5 mg daily by mouth~Imatinib Mesylate: 600 mg daily by mouth"
1187513|NCT00331006|B1|Baseline|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
1187514|NCT00331006|P1|Participant Flow|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
1187515|NCT00331006|O1|Outcome|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
1187516|NCT00331006|O1|Outcome|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
1187517|NCT00331006|O1|Outcome|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
1187518|NCT00331006|O1|Outcome|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
1187519|NCT00331006|O1|Outcome|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
1187520|NCT00331006|O1|Outcome|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
1187521|NCT00331006|O1|Outcome|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
1187522|NCT00331006|O1|Outcome|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
1187523|NCT00331006|E1|Reported Event|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
1187524|NCT00330967|B3|Baseline|Total|Total of all reporting groups
1187525|NCT00330967|B2|Baseline|Group 2|"Femoral Intralipid infusion subjects~20% Intralipid: lipid infusion"
1187526|NCT00330967|B1|Baseline|Group 1|"Systemic Intralipid infusion subjects~20% Intralipid: lipid infusion"
1187527|NCT00330967|P2|Participant Flow|Group 2|"Femoral arterial Intralipid infusion subjects~20% Intralipid: lipid infusion"
1187528|NCT00330967|P1|Participant Flow|Group 1|"Systemic Intralipid infusion subjects~20% Intralipid: lipid infusion"
1187529|NCT00330967|O1|Outcome|Group 2|Femoral Intralipid infusion group
1187536|NCT00330967|E2|Reported Event|Group 2|"Femoral Intralipid infusion group~20% Intralipid: lipid infusion"
1187537|NCT00330967|E1|Reported Event|Group 1|"Systemic Intralipid infusion group~20% Intralipid: lipid infusion"
1187538|NCT00330928|B1|Baseline|Intravascular Coronary Imaging|Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
1187539|NCT00330928|P1|Participant Flow|Intravascular Coronary Imaging|Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
1187540|NCT00330928|O1|Outcome|Intravascular Coronary Imaging|Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
1187541|NCT00330928|O1|Outcome|Intravascular Coronary Imaging|Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
1187542|NCT00330928|E1|Reported Event|Intravascular Coronary Imaging|Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
1187543|NCT00330915|B1|Baseline|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
1187544|NCT00330915|P1|Participant Flow|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
1187545|NCT00330915|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
1187546|NCT00330915|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
1187547|NCT00330915|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
1187548|NCT00330915|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
1187549|NCT00330915|E1|Reported Event|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
1187550|NCT00330876|B1|Baseline|Safety Population|Subjects who received at least one dose of Pitavastatin 2 or 4 mg once daily
1187551|NCT00330876|P2|Participant Flow|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
1187552|NCT00330876|P1|Participant Flow|Pitavastatin 2 mg QD|Pitavastatin 2 mg once daily
1187553|NCT00330876|O2|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
1187554|NCT00330876|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg once daily
1187555|NCT00330876|O2|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
1187556|NCT00330876|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg once daily
1187557|NCT00330876|E2|Reported Event|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
1187558|NCT00330876|E1|Reported Event|Pitavastatin 2 mg QD|Pitavastatin 2 mg once daily
1187559|NCT00330759|B3|Baseline|Total|Total of all reporting groups
1187560|NCT00330759|B2|Baseline|Denosumab|Denosumab 120 mg by subcutaneous injection with an intravenous zoledronic acid placebo once every 4 weeks
1187561|NCT00330759|B1|Baseline|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
1187562|NCT00330759|P2|Participant Flow|Denosumab|Denosumab 120 mg by subcutaneous injection with an intravenous zoledronic acid placebo once every 4 weeks
1187563|NCT00330759|P1|Participant Flow|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
1187564|NCT00330759|O2|Outcome|Denosumab|Denosumab 120 mg by subcutaneous injection with an intravenous zoledronic acid placebo once every 4 weeks
1187565|NCT00330759|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
1187566|NCT00330759|O2|Outcome|Denosumab|Denosumab 120 mg by subcutaneous injection with an intravenous zoledronic acid placebo once every 4 weeks
1187567|NCT00330759|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
1187568|NCT00330759|O2|Outcome|Denosumab|Denosumab 120 mg by subcutaneous injection with an intravenous zoledronic acid placebo once every 4 weeks
1187569|NCT00330759|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
1187570|NCT00330759|E2|Reported Event|Denosumab 120 mg Q4W|
1187571|NCT00330759|E1|Reported Event|Zoledronic Acid 4 mg Q4W|
1187572|NCT00330733|B3|Baseline|Total|Total of all reporting groups
1187573|NCT00330733|B2|Baseline|Arm 2|"Salsalate~Salsalate: Salsalate therapy, double-masked"
1187574|NCT00330733|B1|Baseline|Arm 1|"Matching placebo~Placebo: Matching placebo"
1187575|NCT00330733|P2|Participant Flow|Arm 2|"Salsalate~Salsalate: Salsalate therapy"
1187576|NCT00330733|P1|Participant Flow|Arm 1|"Matching placebo~Placebo: Matching placebo~Seventy-eight individuals entered the placebo run-in phase. Of these, 71 were randomised and 70 returned to receive study medication"
1187577|NCT00330733|O2|Outcome|Arm 2|"Salsalate~Salsalate: Salsalate therapy"
1187578|NCT00330733|O1|Outcome|Arm 1|"Matching placebo~Placebo: Matching placebo"
1187579|NCT00330733|E2|Reported Event|Arm 2|"Salsalate~Salsalate: Salsalate therapy The frequency of tinnitus was relatively low (n=4 for salsalate, n= 2 for placebo), only one instance was graded > mild. Gastrointestinal complaints did not differ between groups (n= 8 for salsalate, n=5 for placebo). No hypoglycaemia occurred."
1187738|NCT00329901|E2|Reported Event|Tdap + Saline|Subjects received Tdap vaccine and saline (placebo)concomitantly, in separate arms
1187580|NCT00330733|E1|Reported Event|Arm 1|"Matching placebo~Placebo: Matching placebo The frequency of tinnitus was relatively low (n=4 for salsalate, n= 2 for placebo), only one instance was graded > mild. Gastrointestinal complaints did not differ between groups (n= 8 for salsalate, n=5 for placebo). No hypoglycaemia occurred."
1187581|NCT00330681|B3|Baseline|Total|Total of all reporting groups
1187582|NCT00330681|B2|Baseline|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
1187583|NCT00330681|B1|Baseline|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
1187584|NCT00330681|P2|Participant Flow|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
1187585|NCT00330681|P1|Participant Flow|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
1187586|NCT00330681|O2|Outcome|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
1187587|NCT00330681|O1|Outcome|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
1187588|NCT00330681|O2|Outcome|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
1187589|NCT00330681|O1|Outcome|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
1187590|NCT00330681|O2|Outcome|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
1187591|NCT00330681|O1|Outcome|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
1187592|NCT00330681|O2|Outcome|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
1187593|NCT00330681|O1|Outcome|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
1187594|NCT00330681|O2|Outcome|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
1187595|NCT00330681|O1|Outcome|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
1187596|NCT00330681|O2|Outcome|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
1187597|NCT00330681|O1|Outcome|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
1187598|NCT00330681|O2|Outcome|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
1187599|NCT00330681|O1|Outcome|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
1187600|NCT00330681|O2|Outcome|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
1187601|NCT00330681|O1|Outcome|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
1187602|NCT00330681|O2|Outcome|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
1187603|NCT00330681|O1|Outcome|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
1187604|NCT00330681|E2|Reported Event|Placebo of MCI-186|Edaravone matched placebo, intravenously infused over 60 min once daily.
1187605|NCT00330681|E1|Reported Event|MCI-186|Edaravone 60 mg, intravenously infused over 60 min once daily.
1187606|NCT00330668|B1|Baseline|rhIGF-1 Injection|All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily.
1187607|NCT00330668|P1|Participant Flow|rhIGF-1 Injection|All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily.
1187608|NCT00330668|O1|Outcome|rhIGF-1 Injection|All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily.
1187609|NCT00330668|O1|Outcome|rhIGF-1 Injection|All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily.
1187610|NCT00330668|O1|Outcome|rhIGF-1 Injection|All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily.
1187611|NCT00330668|O1|Outcome|rhIGF-1 Injection|All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily.
1187612|NCT00330668|E1|Reported Event|rhIGF-1 Injection|All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily.
1187613|NCT00330616|B1|Baseline|Bupropion SR|
1187614|NCT00330616|P1|Participant Flow|Bupropion SR|Dose level 1 = 100mg tablet of Bupropion SR morning, after one week dose 1, increased to Dose 2 twice daily 100mg of Bupropion SR morning and evening, after one week at dose 2 could increase to Dose 3 150mg Bupropion twice daily morning and evening. Subjects stayed at dose level 3 for 6 weeks if tolerated.
1187615|NCT00330616|O1|Outcome|Bupropion SR|
1187616|NCT00330616|O1|Outcome|Bupropion SR|
1187617|NCT00330616|O1|Outcome|Bupropion SR|
1187618|NCT00330616|O1|Outcome|Bupropion SR|
1187619|NCT00330616|O1|Outcome|Bupropion SR|
1187620|NCT00330616|O1|Outcome|Bupropion SR|
1187621|NCT00330616|O1|Outcome|Bupropion SR|
1187622|NCT00330616|O1|Outcome|Bupropion SR|
1187623|NCT00330616|O1|Outcome|Bupropion SR|
1187624|NCT00330616|O1|Outcome|Bupropion SR|
1187625|NCT00330616|O1|Outcome|Bupropion SR|
1187626|NCT00330616|O1|Outcome|Bupropion SR|
1187627|NCT00330616|O1|Outcome|Bupropion SR|
1187628|NCT00330616|O1|Outcome|Bupropion SR|
1187629|NCT00330616|O1|Outcome|Bupropion SR|
1187630|NCT00330616|O1|Outcome|Bupropion SR|
1187667|NCT00330382|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
1191415|NCT00324259|O2|Outcome|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
1187631|NCT00330616|E1|Reported Event|Bupropion SR|Dose level 1 = 100mg tablet of Bupropion SR morning, after one week dose 1, increased to Dose 2 twice daily 100mg of Bupropion SR morning and evening, after one week at dose 2 could increase to Dose 3 150mg Bupropion twice daily morning and evening. Subjects stayed at dose level 3 for 6 weeks if tolerated.
1187632|NCT00330564|B1|Baseline|SU011248 (Sutent, Sunitinib Malate)|50 mg/day orally for 4 weeks
1187633|NCT00330564|P1|Participant Flow|SU011248 (Sutent, Sunitinib Malate)|50 mg/day orally for 4 weeks
1187634|NCT00330564|O1|Outcome|SU011248 (Sutent, Sunitinib Malate)|50 mg/day orally for 4 weeks
1187635|NCT00330564|O1|Outcome|SU011248 (Sutent, Sunitinib Malate)|50 mg/day orally for 4 weeks
1187636|NCT00330564|E1|Reported Event|SU011248 (Sutent, Sunitinib Malate)|50 mg/day orally for 4 weeks
1187637|NCT00330460|B3|Baseline|Total|Total of all reporting groups
1187638|NCT00330460|B2|Baseline|Denosumab 60 mg Q6M|
1187639|NCT00330460|B1|Baseline|Alendronate 70 mg QW|
1187640|NCT00330460|P2|Participant Flow|Denosumab 60 mg Q6M|
1187641|NCT00330460|P1|Participant Flow|Alendronate 70 mg QW|
1187642|NCT00330460|O2|Outcome|Denosumab 60 mg Q6M|
1187654|NCT00330421|B1|Baseline|Group II (Metastatic or Inoperable Sarcomas)|"Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients with responding or stable disease may continue sorafenib in the absence of disease progression or unacceptable toxicity. Biopsy tissue and blood samples are examined for biomarkers and IFP is measured at baseline and on days 28 and 56.~laboratory biomarker analysis : Correlative studies~sorafenib tosylate : Given PO~pharmacological study : Correlative studies~computed tomography : Correlative studies~dynamic contrast-enhanced magnetic resonance imaging : Correlative studies"
1187655|NCT00330421|P2|Participant Flow|Group I (Sarcomas of Extremity)|Patients receive oral sorafenib twice daily on days 1-14. Patients undergo surgical resection of the tumor on approximately day 15. Once patients recover from surgery (and radiotherapy if indicated), patients who demonstrate a clinically and pathologically significant response (≥ 25% reduction in tumor size or ≥ 25% necrosis in the surgical specimen) may continue sorafenib as above for a maximum of 6 months in the absence of disease progression or unacceptable toxicity and at the discretion of the principal investigator. Biopsy tissue and blood samples are examined for biomarkers and interstitial fluid pressure (IFP) is measured at baseline and immediately before surgery.
1187656|NCT00330421|P1|Participant Flow|Group II (Metastatic or Inoperable Sarcomas)|"Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients with responding or stable disease may continue sorafenib in the absence of disease progression or unacceptable toxicity. Biopsy tissue and blood samples are examined for biomarkers and IFP is measured at baseline and on days 28 and 56.~laboratory biomarker analysis : Correlative studies~sorafenib tosylate : Given PO~pharmacological study : Correlative studies~computed tomography : Correlative studies~dynamic contrast-enhanced magnetic resonance imaging : Correlative studies"
1187657|NCT00330421|O1|Outcome|Group II (Metastatic or Inoperable Sarcomas)|"Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients with responding or stable disease may continue sorafenib in the absence of disease progression or unacceptable toxicity. Biopsy tissue and blood samples are examined for biomarkers and IFP is measured at baseline and on days 28 and 56.~laboratory biomarker analysis : Correlative studies~sorafenib tosylate : Given PO~pharmacological study : Correlative studies~computed tomography : Correlative studies~dynamic contrast-enhanced magnetic resonance imaging : Correlative studies"
1187658|NCT00330421|E1|Reported Event|Group II (Metastatic or Inoperable Sarcomas)|"Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients with responding or stable disease may continue sorafenib in the absence of disease progression or unacceptable toxicity. Biopsy tissue and blood samples are examined for biomarkers and IFP is measured at baseline and on days 28 and 56.~laboratory biomarker analysis : Correlative studies~sorafenib tosylate : Given PO~pharmacological study : Correlative studies~computed tomography : Correlative studies~dynamic contrast-enhanced magnetic resonance imaging : Correlative studies"
1187659|NCT00330382|B3|Baseline|Total|Total of all reporting groups
1187660|NCT00330382|B2|Baseline|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
1187661|NCT00330382|B1|Baseline|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
1187662|NCT00330382|P2|Participant Flow|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
1187663|NCT00330382|P1|Participant Flow|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
1187664|NCT00330382|O1|Outcome|Combined Bowman-Birk Inhibitor Concentrate and Placebo Groups|"Patients receive oral Bowman-Birk inhibitor concentrate or Placebo twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally Placebo: Given orally laboratory biomarker analysis: Correlative studies"
1187665|NCT00330382|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
1187666|NCT00330382|O1|Outcome|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
1187736|NCT00329901|O1|Outcome|Tdap+MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
1187668|NCT00330382|O1|Outcome|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
1187669|NCT00330382|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
1187670|NCT00330382|O1|Outcome|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
1187671|NCT00330382|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
1187672|NCT00330382|O1|Outcome|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
1187673|NCT00330382|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
1187674|NCT00330382|O1|Outcome|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
1187675|NCT00330382|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
1187676|NCT00330382|O1|Outcome|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
1187677|NCT00330382|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
1187678|NCT00330382|O1|Outcome|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
1187679|NCT00330382|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
1187680|NCT00330382|O1|Outcome|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
1187681|NCT00330382|E2|Reported Event|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
1187682|NCT00330382|E1|Reported Event|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
1187683|NCT00330174|B3|Baseline|Total|Total of all reporting groups
1187684|NCT00330174|B2|Baseline|Placebo|Matching placebo tablets
1187685|NCT00330174|B1|Baseline|Acamprosate|Acamprosate tablets
1187686|NCT00330174|P2|Participant Flow|Placebo|Matching placebo tablets
1187687|NCT00330174|P1|Participant Flow|Acamprosate|Acamprosate tablets
1187688|NCT00330174|O2|Outcome|Placebo|Matching placebo tablets
1187689|NCT00330174|O1|Outcome|Acamprosate|Acamprosate tablets
1187690|NCT00330174|O2|Outcome|Placebo|Matching placebo tablets
1187691|NCT00330174|O1|Outcome|Acamprosate|Acamprosate tablets
1187692|NCT00330174|O2|Outcome|Placebo|Matching placebo tablets
1187693|NCT00330174|O1|Outcome|Acamprosate|Acamprosate tablets
1187694|NCT00330174|O2|Outcome|Placebo|Matching placebo tablets
1187695|NCT00330174|O1|Outcome|Acamprosate|Acamprosate tablets
1187696|NCT00330174|E2|Reported Event|Placebo|Matching placebo tablets
1187697|NCT00330174|E1|Reported Event|Acamprosate|Acamprosate tablets
1187698|NCT00330161|B1|Baseline|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.~Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
1187699|NCT00330161|P1|Participant Flow|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.~Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
1187700|NCT00330161|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.~Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
1187701|NCT00330161|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.~Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
1187737|NCT00329901|E3|Reported Event|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
1195576|NCT00313144|O4|Outcome|>18 Months to ≤24 Months|
1187702|NCT00330161|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.~Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
1187703|NCT00330161|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.~Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
1187704|NCT00330161|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.~Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
1187750|NCT00329849|O1|Outcome|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
1187751|NCT00329849|O2|Outcome|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
1187705|NCT00330161|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.~Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
1187706|NCT00330161|E1|Reported Event|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.~Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
1187707|NCT00329901|B4|Baseline|Total|Total of all reporting groups
1187708|NCT00329901|B3|Baseline|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
1187709|NCT00329901|B2|Baseline|Tdap + Saline|Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
1187710|NCT00329901|B1|Baseline|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
1187711|NCT00329901|P3|Participant Flow|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
1187712|NCT00329901|P2|Participant Flow|Tdap + Saline|Subjects received Tdap vaccine and saline (placebo)concomitantly, in separate arms
1187713|NCT00329901|P1|Participant Flow|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
1187714|NCT00329901|O3|Outcome|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
1187715|NCT00329901|O2|Outcome|Tdap + Saline|Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
1187716|NCT00329901|O1|Outcome|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
1187717|NCT00329901|O2|Outcome|Tdap + Saline|Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
1187718|NCT00329901|O1|Outcome|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
1187719|NCT00329901|O2|Outcome|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
1187720|NCT00329901|O1|Outcome|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
1187721|NCT00329901|O2|Outcome|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
1187722|NCT00329901|O1|Outcome|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
1187723|NCT00329901|O2|Outcome|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
1187724|NCT00329901|O1|Outcome|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
1187725|NCT00329901|O2|Outcome|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
1187726|NCT00329901|O1|Outcome|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
1187727|NCT00329901|O2|Outcome|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
1187728|NCT00329901|O1|Outcome|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
1187729|NCT00329901|O2|Outcome|Tdap+Saline|Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
1187730|NCT00329901|O1|Outcome|Tdap+ MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
1187731|NCT00329901|O2|Outcome|Tdap+Saline|Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
1187732|NCT00329901|O1|Outcome|Tdap+ MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
1187733|NCT00329901|O2|Outcome|Tdap+Saline|Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
1187734|NCT00329901|O1|Outcome|Tdap+MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
1187735|NCT00329901|O2|Outcome|Tdap+Saline|Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
1187739|NCT00329901|E1|Reported Event|Tdap + MenACWY-CRM|Subjects received Tdap and MenACWY-CRM vaccines concomitantly, in separate arms
1187740|NCT00329849|B3|Baseline|Total|Total of all reporting groups
1187741|NCT00329849|B2|Baseline|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
1187742|NCT00329849|B1|Baseline|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
1187743|NCT00329849|P2|Participant Flow|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
1187744|NCT00329849|P1|Participant Flow|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
1187745|NCT00329849|O4|Outcome|MenACWY-PS_6 to 10 Years|Subjects ≥6 to ≤10 years of age received one vaccination of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
1187746|NCT00329849|O3|Outcome|MenACWY-CRM_6 to 10 Years|Subjects ≥6 to ≤10 years of age received one vaccination of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
1187747|NCT00329849|O2|Outcome|MenACWY-PS_2 to 5 Years|Subjects ≥2 to ≤5 years of age received one vaccination of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
1187748|NCT00329849|O1|Outcome|MenACWY-CRM_2 to 5 Years|Subjects ≥2 to ≤5 years of age received one vaccination of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
1187749|NCT00329849|O2|Outcome|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
1187752|NCT00329849|O1|Outcome|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
1187753|NCT00329849|O2|Outcome|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
1187754|NCT00329849|O1|Outcome|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
1187755|NCT00329849|O2|Outcome|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
1187756|NCT00329849|O1|Outcome|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
1187757|NCT00329849|O2|Outcome|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
1187758|NCT00329849|O1|Outcome|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
1187759|NCT00329849|O2|Outcome|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
1187760|NCT00329849|O1|Outcome|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
1187761|NCT00329849|E2|Reported Event|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
1187762|NCT00329849|E1|Reported Event|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
1187763|NCT00329836|B1|Baseline|Subjects With Cluster Headache|Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled.
1187764|NCT00329836|P1|Participant Flow|Subjects With Cluster Headache|Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled.
1187765|NCT00329836|O1|Outcome|Subjects With Cluster Headache|Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled.
1187766|NCT00329836|E1|Reported Event|Subjects With Cluster Headache|Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled.
1187767|NCT00329784|B5|Baseline|Total|Total of all reporting groups
1187768|NCT00329784|B4|Baseline|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
1187769|NCT00329784|B3|Baseline|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
1187770|NCT00329784|B2|Baseline|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
1187771|NCT00329784|B1|Baseline|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
1187772|NCT00329784|P4|Participant Flow|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
1187887|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
1187773|NCT00329784|P3|Participant Flow|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
1187774|NCT00329784|P2|Participant Flow|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
1187775|NCT00329784|P1|Participant Flow|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
1187776|NCT00329784|O2|Outcome|Peanut Consumption Group|Participants assigned to the peanut consumption group were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
1187777|NCT00329784|O1|Outcome|Peanut Avoidance Group|Participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation.
1187778|NCT00329784|O2|Outcome|Peanut Consumption Group|Participants assigned to the peanut consumption group were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
1187779|NCT00329784|O1|Outcome|Peanut Avoidance Group|Participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation.
1187780|NCT00329784|O2|Outcome|Peanut Consumption Group|Participants assigned to the peanut consumption group were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
1187781|NCT00329784|O1|Outcome|Peanut Avoidance Group|Participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation.
1187782|NCT00329784|O2|Outcome|Peanut Consumption Group|Participants assigned to the peanut consumption group were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
1187783|NCT00329784|O1|Outcome|Peanut Avoidance Group|Participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation.
1187784|NCT00329784|O2|Outcome|Peanut Consumption Group|Participants assigned to the peanut consumption group were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
1187785|NCT00329784|O1|Outcome|Peanut Avoidance Group|Participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation.
1187786|NCT00329784|O2|Outcome|Peanut Consumption Group|Participants assigned to the peanut consumption group were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
1187787|NCT00329784|O1|Outcome|Peanut Avoidance Group|Participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation.
1187788|NCT00329784|O4|Outcome|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
1187789|NCT00329784|O3|Outcome|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
1187790|NCT00329784|O2|Outcome|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
1187791|NCT00329784|O1|Outcome|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
1187792|NCT00329784|E4|Reported Event|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
1187793|NCT00329784|E3|Reported Event|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
1187888|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
1187889|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
1187890|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
1187794|NCT00329784|E2|Reported Event|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
1187795|NCT00329784|E1|Reported Event|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
1187796|NCT00329771|B1|Baseline|Episodic Migraineurs|Eligible subjects with episodic migraine (with or without aura)
1187797|NCT00329771|P1|Participant Flow|Episodic Migraineurs|Eligible subjects with episodic migraine (with or without aura)
1187798|NCT00329771|O1|Outcome|Episodic Migraineurs|Eligible subjects with episodic migraine (with or without aura)
1187799|NCT00329771|E1|Reported Event|Episodic Migraineurs|Eligible subjects with episodic migraine (with or without aura)
1187800|NCT00329745|B3|Baseline|Total|Total of all reporting groups
1187801|NCT00329745|B2|Baseline|Placebo Group|During the primary study (NCT00197210) subjects received two oral doses of placebo.
1187802|NCT00329745|B1|Baseline|Rotarix Group|During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.
1187803|NCT00329745|P2|Participant Flow|Placebo Group|During the primary study (NCT00197210) subjects received two oral doses of placebo.
1187804|NCT00329745|P1|Participant Flow|Rotarix Group|During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.
1187805|NCT00329745|O2|Outcome|Placebo Group|During the primary study (NCT00197210) subjects received two oral doses of placebo.
1199140|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
1187806|NCT00329745|O1|Outcome|Rotarix Group|During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.
1187807|NCT00329745|O2|Outcome|Placebo Group|During the primary study (NCT00197210) subjects received two oral doses of placebo.
1187808|NCT00329745|O1|Outcome|Rotarix Group|During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.
1187809|NCT00329745|E2|Reported Event|Placebo Group|During the primary study (NCT00197210) subjects received two oral doses of placebo.
1187810|NCT00329745|E1|Reported Event|Rotarix Group|During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.
1187811|NCT00329732|B3|Baseline|Total|Total of all reporting groups
1187812|NCT00329732|B2|Baseline|Saline (Placebo)|
1187813|NCT00329732|B1|Baseline|Lidocaine/Bupivicaine|
1187814|NCT00329732|P2|Participant Flow|Saline (Placebo)|
1187815|NCT00329732|P1|Participant Flow|Lidocaine/Bupivicaine|
1187816|NCT00329732|O1|Outcome|Lidocaine/Bupivicaine|
1187817|NCT00329732|E2|Reported Event|Saline (Placebo)|
1187818|NCT00329732|E1|Reported Event|Lidocaine/Bupivicaine|
1187819|NCT00329719|B5|Baseline|Total|Total of all reporting groups
1187820|NCT00329719|B4|Baseline|Phase II, Arm D|"Phase II, Arm D, Group III (patients who received prior anti-VEGF therapy)~Patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
1187821|NCT00329719|B3|Baseline|Phase II, Arm C|"Phase II, Arm C, Group II (patients undergoing surgery)~Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV~conventional surgery: Undergo surgery"
1187822|NCT00329719|B2|Baseline|Phase II, Arm B|"Phase II, Arm B, Group I (patients not undergoing surgery)~Patients receive sorafenib and temsirolimus at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
1187823|NCT00329719|B1|Baseline|Phase I, Arm A|"Phase I, Arm A, Dose Escalation~Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~sorafenib tosylate: Given PO~temsirolimus: Given IV"
1187824|NCT00329719|P4|Participant Flow|Phase II, Arm D|"Phase II, Arm D, Group III (patients who received prior anti-VEGF therapy)~Patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
1187825|NCT00329719|P3|Participant Flow|Phase II, Arm C|"Phase II, Arm C, Group II (patients undergoing surgery)~Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV~conventional surgery: Undergo surgery"
1187826|NCT00329719|P2|Participant Flow|Phase II, Arm B|"Phase II, Arm B, Group I (patients not undergoing surgery)~Patients receive sorafenib and temsirolimus at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
1187827|NCT00329719|P1|Participant Flow|Phase I, Arm A|"Phase I, Arm A, Dose Escalation~Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~sorafenib tosylate: Given PO~temsirolimus: Given IV"
1187828|NCT00329719|O4|Outcome|Phase II, Arm D|"Phase II, Arm D, Group III (patients who received prior anti-VEGF therapy)~Patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
1187891|NCT00329602|E3|Reported Event|Open-Label Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
1187829|NCT00329719|O3|Outcome|Phase II, Arm C|"Phase II, Arm C, Group II (patients undergoing surgery)~Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV~conventional surgery: Undergo surgery"
1187830|NCT00329719|O2|Outcome|Phase II, Arm B|"Phase II, Arm B, Group I (patients not undergoing surgery)~Patients receive sorafenib and temsirolimus at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
1187831|NCT00329719|O1|Outcome|Phase I, Arm A|"Phase I, Arm A, Dose Escalation~Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~sorafenib tosylate: Given PO~temsirolimus: Given IV"
1187832|NCT00329719|O4|Outcome|Phase II, Arm D|"Phase II, Arm D, Group III (patients who received prior anti-VEGF therapy)~Patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
1187833|NCT00329719|O3|Outcome|Phase II, Arm C|"Phase II, Arm C, Group II (patients undergoing surgery)~Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV~conventional surgery: Undergo surgery"
1188699|NCT00328627|P3|Participant Flow|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1187834|NCT00329719|O2|Outcome|Phase II, Arm B|"Phase II, Arm B, Group I (patients not undergoing surgery)~Patients receive sorafenib and temsirolimus at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
1187835|NCT00329719|O1|Outcome|Phase I, Arm A|"Phase I, Arm A, Dose Escalation~Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~sorafenib tosylate: Given PO~temsirolimus: Given IV"
1187836|NCT00329719|O4|Outcome|Phase II, Arm D|"Phase II, Arm D, Group III (patients who received prior anti-VEGF therapy)~Patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
1187837|NCT00329719|O3|Outcome|Phase II, Arm C|"Phase II, Arm C, Group II (patients undergoing surgery)~Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV~conventional surgery: Undergo surgery"
1187838|NCT00329719|O2|Outcome|Phase II, Arm B|"Phase II, Arm B, Group I (patients not undergoing surgery)~Patients receive sorafenib and temsirolimus at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
1187839|NCT00329719|O1|Outcome|Phase I, Arm A|"Phase I, Arm A, Dose Escalation~Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~sorafenib tosylate: Given PO~temsirolimus: Given IV"
1187840|NCT00329719|O4|Outcome|Phase II, Arm D|"Phase II, Arm D, Group III (patients who received prior anti-VEGF therapy)~Patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
1187841|NCT00329719|O3|Outcome|Phase II, Arm C|"Phase II, Arm C, Group II (patients undergoing surgery)~Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV~conventional surgery: Undergo surgery"
1187842|NCT00329719|O2|Outcome|Phase II, Arm B|"Phase II, Arm B, Group I (patients not undergoing surgery)~Patients receive sorafenib and temsirolimus at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
1187843|NCT00329719|O1|Outcome|Phase I, Arm A|"Phase I, Arm A, Dose Escalation~Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~sorafenib tosylate: Given PO~temsirolimus: Given IV"
1187844|NCT00329719|E4|Reported Event|Phase II, Arm D|"Patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
1187845|NCT00329719|E3|Reported Event|Phase II, Arm C|"Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV~conventional surgery: Undergo surgery"
1187846|NCT00329719|E2|Reported Event|Phase II, Arm B|"Patients receive sorafenib and temsirolimus at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
1187892|NCT00329602|E2|Reported Event|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
1187893|NCT00329602|E1|Reported Event|Double-blind Placebo|Matching placebo tablets
1187894|NCT00329550|B4|Baseline|Total|Total of all reporting groups
1187847|NCT00329719|E1|Reported Event|Phase I, Arm A|"Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~sorafenib tosylate: Given PO~temsirolimus: Given IV"
1187848|NCT00329641|B1|Baseline|Sorafenib, Carboplatin, Paclitaxel|
1187849|NCT00329641|P1|Participant Flow|Sorafenib, Carboplatin, Paclitaxel|Standard carboplatin and paclitaxel doses with the addition of sorafenib (800 mg daily)
1187850|NCT00329641|O1|Outcome|Intervention|Sorafenib, Carboplatin, Paclitaxel
1187851|NCT00329641|O1|Outcome|Sorafenib, Carboplatin, Paclitaxel|
1187852|NCT00329641|O1|Outcome|Sorafenib, Carboplatin, Paclitaxel|
1187853|NCT00329641|O1|Outcome|Sorafenib, Carboplatin, Paclitaxel|
1187854|NCT00329641|E1|Reported Event|Intervention|Sorafenib, Carboplatin, Paclitaxel
1187855|NCT00329602|B3|Baseline|Total|Total of all reporting groups
1187856|NCT00329602|B2|Baseline|Double-Blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
1187857|NCT00329602|B1|Baseline|Double-Blind Placebo|Matching placebo tablets
1187858|NCT00329602|P3|Participant Flow|Open-label Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
1188890|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1187859|NCT00329602|P2|Participant Flow|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
1187860|NCT00329602|P1|Participant Flow|Double-blind Placebo|Matching placebo tablets
1187861|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Double-Blind Ropinirole participants (receiving Ropinirole IR [immediate release] tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day) who were not excluded from the IRLS post-hoc analysis
1187862|NCT00329602|O1|Outcome|Double-blind Placebo|Double-Blind Placebo participants (receiving matching placebo tablets) who were not excluded from the IRLS post-hoc analysis
1187863|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Double-Blind Ropinirole participants (receiving Ropinirole IR [immediate release] tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day) who were not in the center groups with the highest or lowest treatment effects
1187864|NCT00329602|O1|Outcome|Double-blind Placebo|Double-Blind Placebo participants (receiving matching placebo tablets) who were not in the center groups with the highest or lowest treatment effects
1187865|NCT00329602|O1|Outcome|Open-label Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
1187866|NCT00329602|O4|Outcome|Open-label Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
1187867|NCT00329602|O3|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
1187868|NCT00329602|O2|Outcome|Double-blind Placebo|Matching placebo tablets
1187869|NCT00329602|O1|Outcome|Overall Study|
1187870|NCT00329602|O1|Outcome|Open-label Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
1187871|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
1187872|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
1187873|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
1187874|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
1187875|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
1187876|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
1187877|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
1187878|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
1187879|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
1187880|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
1187881|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
1187882|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
1187883|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
1187884|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
1187885|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
1187886|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
1188142|NCT00329550|E4|Reported Event|Total 1 (This Extension Study Only)|This includes all adverse event data collected in this extension study for all 40 subjects who entered this extension study.
1187895|NCT00329550|B3|Baseline|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187896|NCT00329550|B2|Baseline|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187897|NCT00329550|B1|Baseline|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187898|NCT00329550|P3|Participant Flow|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187899|NCT00329550|P2|Participant Flow|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187900|NCT00329550|P1|Participant Flow|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187901|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187902|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187903|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187904|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187905|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187906|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187907|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187908|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187909|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187910|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187911|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187912|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187913|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187914|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187915|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187916|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187917|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187918|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187919|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187920|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187921|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187922|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187923|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187924|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187925|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188629|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
1187926|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187927|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187928|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187929|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187930|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187931|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187932|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187933|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1190880|NCT00325819|B2|Baseline|Placebo|Subjects who were randomized to receive placebo
1187934|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187935|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187936|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187937|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187938|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187939|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187940|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187941|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187942|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187943|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187944|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187945|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187946|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187947|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187948|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187949|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187950|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187951|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187952|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187953|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187954|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187955|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187956|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188630|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
1188631|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
1187957|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187958|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187959|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187960|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187961|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187962|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187963|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187964|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187965|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187966|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187967|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187968|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187969|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187970|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187971|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187972|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187973|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187974|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187975|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187976|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187977|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187978|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187979|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187980|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187981|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187982|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187983|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187984|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187985|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187986|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187987|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188632|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
1188633|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
1187988|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187989|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187990|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187991|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187992|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187993|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187994|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187995|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187996|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187997|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187998|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1187999|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188000|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188001|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188002|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188003|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188004|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188005|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188006|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188007|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188008|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188009|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188010|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188011|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188012|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188013|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188014|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188015|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188016|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188017|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188018|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188634|NCT00329030|E2|Reported Event|R-BEAM|Rituxan/BEAM
1188635|NCT00329030|E1|Reported Event|B-BEAM|Bexxar/BEAM
1188019|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188020|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188021|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188022|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188023|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188024|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188025|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188026|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188027|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188028|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188029|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188030|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188031|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188032|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188033|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188034|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188035|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188036|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188037|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188038|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188039|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188040|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188041|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188042|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188043|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188044|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188045|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188046|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188047|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188048|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188049|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188636|NCT00328926|B4|Baseline|Total|Total of all reporting groups
1188050|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188051|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188052|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188053|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188054|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188055|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188056|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188057|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188058|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188059|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188060|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188061|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188062|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188063|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188064|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188065|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188066|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188067|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188068|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188069|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188070|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188071|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188072|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188073|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188074|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188075|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188076|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188077|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188078|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188079|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188080|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1190224|NCT00328614|P6|Participant Flow|Samarium-153 (2.0 mCi/kg)|Cohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
1188081|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188082|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188083|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188084|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188085|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188086|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188087|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188119|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188088|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188089|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188090|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188091|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188092|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188093|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188094|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188095|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188096|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188097|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188098|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188099|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188100|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188101|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188102|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188103|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188104|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188105|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188106|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188107|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188108|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188109|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188110|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188111|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1190847|NCT00326001|P1|Participant Flow|Gold Tip Catheter|Patients allocated to be ablated by 8-mm gold tip catheter
1188112|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188113|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188114|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188115|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188116|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188117|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188118|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188120|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188121|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188122|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188123|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188124|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188125|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188126|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188127|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188128|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188129|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188130|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188131|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188132|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188133|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188134|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188135|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188136|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188137|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188138|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188139|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188140|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188141|NCT00329550|E5|Reported Event|Total 2 (Treatment With CZP in Main Study and Extension Study)|This includes all adverse event data from the 6-week double-blind main study (NCT00291668) and this extension study for all 40 subjects who entered this extension study, whilst they were receiving treatment with certolizumab pegol (CZP) in either study. Adverse events recorded in the double-blind main study (NCT00291668) for subjects who received Placebo treatment during that study are not included here.
1190848|NCT00326001|O2|Outcome|Pt-Ir Tip Catheter|Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
1188143|NCT00329550|E3|Reported Event|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188144|NCT00329550|E2|Reported Event|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188145|NCT00329550|E1|Reported Event|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188146|NCT00329524|B1|Baseline|Active Versus Sham TMS|Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration.
1188147|NCT00329524|P1|Participant Flow|Active Versus Sham TMS|Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration.
1188174|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188148|NCT00329524|O1|Outcome|Active Versus Sham TMS|Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration.
1188149|NCT00329524|O1|Outcome|Active Versus Sham TMS|Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration.
1188150|NCT00329524|O1|Outcome|Active Versus Sham TMS|Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration.
1188151|NCT00329524|E1|Reported Event|Active Versus Sham Treatment|"Subjects randomly assigned to active and sham TMS separated by one week interval.~Repetitive Transcranial Magnetic Stimulation (rTMS): TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging. TMS will then be optimized by identifying the area of maximal tinnitus suppression, within the area of asymmetry, by delivering single 1-Hz pulses of TMS at the MT. The area of maximal tinnitus suppression, as reported by the patient, will then be targeted for treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days.If no area of maximal tinnitus suppression can be found in the hemisphere initially targeted for treatment based on PET, we will perform the optimization procedure in a homologous region of the opposite cerebral hemisphere to determine if maximal area of suppression can be found there. Each group will then crossover to sham and active stimulation conditions, respectiv"
1188152|NCT00329433|B3|Baseline|Total|Total of all reporting groups
1188153|NCT00329433|B2|Baseline|Heparin|Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).
1188154|NCT00329433|B1|Baseline|Desirudin|Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300.
1188155|NCT00329433|P2|Participant Flow|Heparin|Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).
1188156|NCT00329433|P1|Participant Flow|Desirudin|Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300.
1188157|NCT00329433|O2|Outcome|Heparin|Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).
1188158|NCT00329433|O1|Outcome|Desirudin|Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300.
1188159|NCT00329433|E2|Reported Event|Heparin|Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).
1188160|NCT00329433|E1|Reported Event|Desirudin|Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300.
1188161|NCT00329420|B4|Baseline|Total|Total of all reporting groups
1188162|NCT00329420|B3|Baseline|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188163|NCT00329420|B2|Baseline|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188164|NCT00329420|B1|Baseline|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188165|NCT00329420|P3|Participant Flow|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188166|NCT00329420|P2|Participant Flow|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188167|NCT00329420|P1|Participant Flow|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1190225|NCT00328614|P5|Participant Flow|Samarium-153 (1.5 mCi/kg)|Cohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
1188168|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188169|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188170|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188171|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188172|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188173|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188175|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188176|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188177|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188178|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188179|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188180|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188181|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188182|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188183|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188184|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188185|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188186|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188187|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188188|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188189|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188190|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188191|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188192|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188193|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188194|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188195|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188683|NCT00328627|B7|Baseline|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188196|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188197|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188198|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188199|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188200|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188201|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188202|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188203|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188204|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188205|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188206|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188207|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188208|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188209|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188210|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188211|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188212|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188213|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188214|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188215|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188216|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188217|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188218|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188219|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188220|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188221|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188222|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188223|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188224|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188225|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188226|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188227|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188228|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188229|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188230|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188231|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188232|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188233|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188234|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188235|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188236|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188237|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188238|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188239|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188240|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188241|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188242|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188243|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188244|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188245|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188246|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188247|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188248|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188249|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188250|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188251|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188252|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188684|NCT00328627|B6|Baseline|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188253|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188254|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188255|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188256|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188257|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188258|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188259|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188260|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188261|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188262|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188263|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188264|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188265|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188266|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188267|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188268|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188269|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188270|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188271|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188272|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188273|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188274|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188275|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188276|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188277|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188278|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188279|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188280|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188281|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188282|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188283|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188284|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188285|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188286|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188287|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188288|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188289|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188290|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188291|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188292|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188293|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188294|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188295|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188296|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188297|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188298|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188299|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188300|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188301|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188302|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188303|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188304|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188305|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188306|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188307|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188308|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188309|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188685|NCT00328627|B5|Baseline|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188310|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188311|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188312|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188313|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188314|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188315|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188316|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188317|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188318|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188319|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188320|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188321|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188322|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188323|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188324|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188325|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188326|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188327|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188328|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188329|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188330|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188331|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188332|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188333|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188334|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188335|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188336|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188337|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188338|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188339|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188340|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188341|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188342|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188343|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188344|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188345|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188346|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188347|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188348|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188349|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188350|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188351|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188352|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188353|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188354|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188355|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188356|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188357|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188358|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188359|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188360|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188361|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188362|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188363|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188364|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188365|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188366|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188686|NCT00328627|B4|Baseline|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188367|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188368|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188369|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188370|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188371|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188372|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188373|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188374|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188375|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188376|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188377|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188378|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188379|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188380|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188381|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188382|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188383|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188384|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188385|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188386|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188387|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188388|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188389|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188390|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188391|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188392|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188393|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188394|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188395|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188396|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188397|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188398|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188399|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188400|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188401|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188402|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188403|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188404|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188405|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188406|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188407|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188408|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188409|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188410|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188411|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188412|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188413|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188414|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188415|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188416|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188417|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188418|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188419|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188420|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188421|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188422|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188423|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188687|NCT00328627|B3|Baseline|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188424|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188425|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188426|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188427|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188428|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188429|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188430|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188431|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188432|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188433|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188434|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188435|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188436|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188437|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188438|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188439|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188440|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188441|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188442|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188443|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188444|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188445|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188446|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188447|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188448|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188449|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188450|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188451|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188452|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188453|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188454|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188455|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188456|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188457|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188458|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188459|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188460|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188461|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188462|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188463|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188464|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188465|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188466|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188467|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188468|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188469|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188470|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188471|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188472|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188473|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188474|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188475|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188476|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188477|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188478|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188479|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188480|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188688|NCT00328627|B2|Baseline|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188481|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188482|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188483|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188484|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188485|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188486|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188487|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188488|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188489|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188490|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188491|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188492|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188493|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188494|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188495|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188496|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188497|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188498|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188499|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188500|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188501|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188502|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188503|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188504|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188505|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188506|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188507|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188508|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188509|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188510|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188511|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188512|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188513|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188514|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188515|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188516|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188517|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188518|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188519|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188520|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188521|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188522|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188523|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188524|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188525|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188526|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188527|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188528|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188529|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188530|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188531|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188532|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188533|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188534|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188535|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188536|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188537|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188689|NCT00328627|B1|Baseline|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188538|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188539|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188540|NCT00329420|E5|Reported Event|Total 2 (Treatment With CZP in Main Study and Extension Study)|This includes all adverse event data from the 6-week double-blind main study (N00291668) and this extension study for all 46 subjects who entered this extension study C87048, whilst they were receiving treatment with certolizumab pegol (CZP) in either study. Adverse events recorded in the double-blind main study (NCT00291668) for subjects who received Placebo treatment during that study are not included here.
1188541|NCT00329420|E4|Reported Event|Total 1 (This Extension Study Only)|This includes all adverse event data collected in this extension study for all 46 subjects who entered this extension study.
1188542|NCT00329420|E3|Reported Event|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188543|NCT00329420|E2|Reported Event|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1199141|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
1188544|NCT00329420|E1|Reported Event|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
1188545|NCT00329407|B1|Baseline|Topiramate Treatment|In this open label non-placebo controlled trial all subjects received topiramate, the active medication.
1188546|NCT00329407|P1|Participant Flow|Topiramate Treatment|In this open label non-placebo controlled trial all subjects received topiramate, the active medication.
1188547|NCT00329407|O1|Outcome|Topiramate Treatment|In this open label non-placebo controlled trial all subjects received topiramate, the active medication.
1188548|NCT00329407|O1|Outcome|Topiramate Treatment|In this open label non-placebo controlled trial all subjects received topiramate, the active medication.
1188549|NCT00329407|E1|Reported Event|Topiramate Treatment|In this open label non-placebo controlled trial all subjects received topiramate, the active medication.
1188550|NCT00329238|B3|Baseline|Total|Total of all reporting groups
1188551|NCT00329238|B2|Baseline|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
1188552|NCT00329238|B1|Baseline|Dabigatran|150 mg twice daily, total daily dose 300 mg
1188553|NCT00329238|P2|Participant Flow|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
1188554|NCT00329238|P1|Participant Flow|Dabigatran|150 mg twice daily, total daily dose 300 mg
1188555|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
1188556|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
1188557|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
1188558|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
1188559|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
1188560|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
1188561|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
1188562|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
1188563|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
1188564|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
1188565|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
1188566|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
1188567|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
1188568|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
1188569|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
1188570|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
1188571|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
1188572|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
1188573|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
1188574|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
1188575|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
1188576|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
1188577|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
1188578|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
1188579|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
1188580|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
1188581|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
1188582|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
1188583|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
1188584|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
1188585|NCT00329238|E4|Reported Event|Post Warfarin|
1188586|NCT00329238|E3|Reported Event|Post Dabigatran|
1188587|NCT00329238|E2|Reported Event|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
1188588|NCT00329238|E1|Reported Event|Dabigatran|150 mg twice daily, total daily dose 300 mg
1188690|NCT00328627|P12|Participant Flow|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190311|NCT00328094|O1|Outcome|Continuous Insulin Infusion|Tight glucose group with insulin infusion
1188589|NCT00329160|B1|Baseline|Rosuvastatin|rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.
1188590|NCT00329160|P1|Participant Flow|Rosuvastatin|rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.
1188591|NCT00329160|O1|Outcome|Rosuvastatin|rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.
1188592|NCT00329160|O1|Outcome|Rosuvastatin|rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.
1188698|NCT00328627|P4|Participant Flow|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188593|NCT00329160|O1|Outcome|Rosuvastatin|rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.
1188594|NCT00329160|O1|Outcome|Rosuvastatin|rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.
1188595|NCT00329160|E1|Reported Event|Rosuvastatin|rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.
1188596|NCT00329108|B3|Baseline|Total|Total of all reporting groups
1188597|NCT00329108|B2|Baseline|Olanzapine|Olanzapine was started at 15 mg/day (15 mg once daily [QD]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator’s discretion.
1188598|NCT00329108|B1|Baseline|Ziprasidone|Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator’s discretion.
1188599|NCT00329108|P2|Participant Flow|Olanzapine|Olanzapine was started at 15 mg/day (15 mg once daily [QD]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator’s discretion.
1188600|NCT00329108|P1|Participant Flow|Ziprasidone|Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator’s discretion.
1188601|NCT00329108|O2|Outcome|Olanzapine|Olanzapine was started at 15 mg/day (15 mg once daily [QD]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator’s discretion.
1188602|NCT00329108|O1|Outcome|Ziprasidone|Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator’s discretion.
1188603|NCT00329108|E2|Reported Event|Olanzapine|Olanzapine was started at 15 mg/day (15 mg once daily [QD]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator’s discretion.
1188604|NCT00329108|E1|Reported Event|Ziprasidone|Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator’s discretion.
1188605|NCT00329030|B3|Baseline|Total|Total of all reporting groups
1188606|NCT00329030|B2|Baseline|R-BEAM|Rituxan/BEAM
1188607|NCT00329030|B1|Baseline|B-BEAM|Bexxar/BEAM
1188608|NCT00329030|P2|Participant Flow|R-BEAM|Patients received Rituxan/BEAM, with Rituxan 375 mg/m2 IV Days -19 and -12, BCNU 300 mg/m2 Day -6, Etoposide 100 mg/m2 BID Days -5 to -2, Cytarabine 100 mg/m2 BID Days -5 to -2, and Melphalan 140 mg/m2 Day -1 followed by ASCT
1188609|NCT00329030|P1|Participant Flow|B-BEAM|Patients received Bexxar/BEAM with the dosimetric dose of 5 mCi Bexxar on Day -19 and the therapeutic dose calculated to administer 75 cGy total body dose (TBD) on Day -12. Patients will then receive carmustine (BCNU) 300 mg/m2 Day -6, Etoposide 100 mg/m2 BID Days -5 to -2, Cytarabine 100 mg/m2 BID Days -5 to -2, and Melphalan 140 mg/m2 Day -1 followed by ASCT
1188610|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
1188611|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
1188612|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
1188613|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
1188614|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
1188615|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
1188616|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
1188617|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
1188618|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
1188619|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
1188620|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
1188621|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
1188622|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
1188623|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
1188624|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
1188625|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
1188626|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
1188627|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
1188628|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
1188637|NCT00328926|B3|Baseline|Placebo|Placebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
1188638|NCT00328926|B2|Baseline|Luveris® 25 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
1188639|NCT00328926|B1|Baseline|Luveris® 75 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 international unit (IU) administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum estradiol (E2) levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
1188640|NCT00328926|P3|Participant Flow|Placebo|Placebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
1188641|NCT00328926|P2|Participant Flow|Luveris® 25 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
1188642|NCT00328926|P1|Participant Flow|Luveris® 75 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 international unit (IU) administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum estradiol (E2) levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
1188643|NCT00328926|O3|Outcome|Placebo|Placebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
1188644|NCT00328926|O2|Outcome|Luveris® 25 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
1188645|NCT00328926|O1|Outcome|Luveris® 75 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 international unit (IU) administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum estradiol (E2) levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
1195577|NCT00313144|O3|Outcome|>12 Months to ≤18 Months|
1188646|NCT00328926|O3|Outcome|Placebo|Placebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
1188647|NCT00328926|O2|Outcome|Luveris® 25 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
1188648|NCT00328926|O1|Outcome|Luveris® 75 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 international unit (IU) administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum estradiol (E2) levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
1188649|NCT00328926|O3|Outcome|Placebo|Placebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
1188650|NCT00328926|O2|Outcome|Luveris® 25 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
1188651|NCT00328926|O1|Outcome|Luveris® 75 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 international unit (IU) administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum estradiol (E2) levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
1188652|NCT00328926|E3|Reported Event|Placebo|Placebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
1188653|NCT00328926|E2|Reported Event|Luveris® 25 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
1188654|NCT00328926|E1|Reported Event|Luveris® 75 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 international unit (IU) administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum estradiol (E2) levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
1188655|NCT00328861|B3|Baseline|Total|Total of all reporting groups
1188656|NCT00328861|B2|Baseline|NK Cells + IL-2: Renal Cell|Renal cell (kidney cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
1188657|NCT00328861|B1|Baseline|NK Cells + IL-2: Melanoma|Melanoma (skin cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
1188658|NCT00328861|P2|Participant Flow|NK Cells + IL-2: Renal Cell|Renal cell (kidney cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
1188659|NCT00328861|P1|Participant Flow|NK Cells + IL-2: Melanoma|Melanoma (skin cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
1190881|NCT00325819|B1|Baseline|Acetaminophen|Subjects who were randomized to receive acetaminophen
1188660|NCT00328861|O2|Outcome|NK Cells + IL-2: Renal Cell|Renal cell (kidney cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
1188661|NCT00328861|O1|Outcome|NK Cells + IL-2: Melanoma|Melanoma (skin cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
1188662|NCT00328861|O2|Outcome|NK Cells + IL-2: Renal Cell|Renal cell (kidney cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
1188663|NCT00328861|O1|Outcome|NK Cells + IL-2: Melanoma|Melanoma (skin cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
1188664|NCT00328861|E2|Reported Event|NK Cells + IL-2: Renal Cell|Renal cell (kidney cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
1188665|NCT00328861|E1|Reported Event|NK Cells + IL-2: Melanoma|Melanoma (skin cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
1188666|NCT00328783|B1|Baseline|Active Breathing Coordinator|"Patients breathe through the ABC device~Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms."
1188667|NCT00328783|P1|Participant Flow|Active Breathing Coordinator|"Patients breathe through the ABC device~Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms."
1188668|NCT00328783|O1|Outcome|Active Breathing Coordinator|"Patients breathe through the ABC device~Active Breathing Coordinator (ABC): The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms."
1188669|NCT00328783|O1|Outcome|Active Breathing Coordinator|"Patients breathe through the ABC device~Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms."
1188670|NCT00328783|E1|Reported Event|Active Breathing Coordinator|"Patients breathe through the ABC device~Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms."
1188671|NCT00328770|B1|Baseline|All Study Patients|All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation
1188672|NCT00328770|P1|Participant Flow|All Study Patients|All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation
1188673|NCT00328770|O1|Outcome|All Study Patients|All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation
1188674|NCT00328770|O1|Outcome|All Study Patients|All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation
1188675|NCT00328770|O1|Outcome|Patient Survival|1 and 4 year patient survival
1188676|NCT00328770|E1|Reported Event|All Study Patients|All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation
1188677|NCT00328627|B13|Baseline|Total|Total of all reporting groups
1188678|NCT00328627|B12|Baseline|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188679|NCT00328627|B11|Baseline|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188680|NCT00328627|B10|Baseline|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188681|NCT00328627|B9|Baseline|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188682|NCT00328627|B8|Baseline|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188691|NCT00328627|P11|Participant Flow|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188692|NCT00328627|P10|Participant Flow|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188693|NCT00328627|P9|Participant Flow|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188694|NCT00328627|P8|Participant Flow|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188695|NCT00328627|P7|Participant Flow|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188696|NCT00328627|P6|Participant Flow|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188697|NCT00328627|P5|Participant Flow|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188700|NCT00328627|P2|Participant Flow|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188701|NCT00328627|P1|Participant Flow|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188702|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188703|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188704|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188705|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188706|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188707|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188708|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188709|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188710|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188711|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188712|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188713|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188714|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188715|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188716|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188717|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188718|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188719|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188720|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188721|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188722|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188723|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188724|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188725|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188726|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1188727|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1188728|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1188729|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188730|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188731|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188732|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188733|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188734|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188735|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188736|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188737|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189236|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1188738|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188739|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188740|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188741|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188742|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188743|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188744|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188745|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188746|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188747|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188748|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188749|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188750|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188751|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188752|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188753|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1188754|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1188755|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1188756|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188757|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188758|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188759|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188760|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188761|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188762|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188763|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188764|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188765|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188766|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188998|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1188767|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188768|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188769|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188770|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188771|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188772|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188773|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188774|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188775|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188776|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188777|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188778|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188779|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188780|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1188781|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1188782|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1188783|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188784|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188785|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188786|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188787|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188788|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188789|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188790|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188791|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188792|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188793|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188794|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188795|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188796|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188797|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188798|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188799|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188800|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188801|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188802|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188803|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188804|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189992|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1188805|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188806|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188807|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1188808|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1188809|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1188810|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188811|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188812|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188813|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189237|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1188814|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188815|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188816|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188817|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188818|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188819|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188820|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188821|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188822|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188823|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188824|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188825|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188826|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188827|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188828|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188829|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188830|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188831|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188832|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188833|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188834|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1188835|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1188836|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1188837|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188838|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188839|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188840|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188841|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188842|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188843|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190312|NCT00328094|E2|Reported Event|Intermittent Insulin Bolus|Intermittent insulin boluses group
1188844|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188845|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188846|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188847|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188848|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188849|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188850|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188851|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188852|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188853|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188854|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188855|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188856|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188857|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188858|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188859|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188860|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188861|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1188862|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1188863|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1188864|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188865|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188866|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188867|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188868|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188869|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188870|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188871|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188872|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188873|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188874|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188875|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188876|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188877|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188878|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188879|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188880|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188881|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189993|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1188882|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188883|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188884|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188885|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188886|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188887|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188888|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1188889|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1191104|NCT00325195|P3|Participant Flow|Placebo|placebo infusion every 2 weeks
1188891|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188892|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188893|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188894|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188895|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188896|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188897|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188898|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188899|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188900|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188901|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188902|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188903|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188904|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188905|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188906|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188907|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188908|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188909|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188910|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188911|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188912|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188913|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188914|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188915|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1188916|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1188917|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1188918|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188919|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188920|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190313|NCT00328094|E1|Reported Event|Continuous Insulin Infusion|Tight glucose group with insulin infusion
1188921|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188922|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188923|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188924|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188925|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188926|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188927|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188928|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188929|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188930|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188931|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188932|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188933|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188934|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188935|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188936|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188937|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188938|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188939|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188940|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188941|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188942|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1188943|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1188944|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1188945|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188946|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188947|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188948|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188949|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188950|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188951|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188952|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188953|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188954|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188955|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188956|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188957|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188958|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189994|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1188959|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188960|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188961|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188962|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188963|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188964|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188965|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188966|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188967|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188968|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188969|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1188970|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1188971|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1188972|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188973|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188974|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188975|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188976|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188977|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188978|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188979|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188980|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188981|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188982|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188983|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188984|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188985|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188986|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1188987|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188988|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188989|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1188990|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188991|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188992|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1188993|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188994|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188995|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1188996|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1188997|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1188999|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189000|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189001|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189002|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189003|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189004|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189005|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189006|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189007|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189008|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189009|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189010|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189011|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189012|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189013|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189014|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189015|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189016|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189017|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189018|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189019|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189020|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189021|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189022|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189023|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1189024|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1189025|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1189026|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189027|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189028|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189029|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189030|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189031|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189032|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189033|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189034|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189035|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189036|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190314|NCT00328042|B3|Baseline|Total|Total of all reporting groups
1189037|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189038|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189039|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189040|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189041|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189042|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189043|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189044|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189045|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189046|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189047|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189048|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189049|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189050|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1189051|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1189052|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1189053|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189054|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189055|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189056|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189057|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189058|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189059|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189060|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189061|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189062|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189063|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189064|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189065|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189066|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189067|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189068|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189069|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189070|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189071|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189072|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189073|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189074|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190315|NCT00328042|B2|Baseline|Arm 2|Self-management self-study: This is an individual self-paced at home study program.
1189075|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189076|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189077|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1189078|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1189079|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1189080|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189081|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189082|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189083|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189084|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189085|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189086|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189087|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189088|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189089|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189090|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189091|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189092|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189093|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189094|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189095|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189096|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189097|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189098|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189099|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189100|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189101|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189102|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189103|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189104|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1189105|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1189106|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1189107|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189108|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189109|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189110|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189111|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189112|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189113|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190849|NCT00326001|O1|Outcome|Gold Tip Catheter|Patients allocated to be ablated by 8-mm gold tip catheter
1189114|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189115|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189116|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189117|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189118|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189119|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189120|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189121|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189122|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189123|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189124|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189125|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189126|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189127|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189128|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189129|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189130|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189131|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1189132|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1189133|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1189134|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189135|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189136|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189137|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189138|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189139|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189140|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189141|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189142|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189143|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189144|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189145|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189146|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189147|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189148|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189149|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189150|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189151|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190316|NCT00328042|B1|Baseline|Arm 1|Self-Management Workshop: The workshop is a once per week 2.5 hour group that meets for six weeks.
1189152|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189153|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189154|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189155|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189156|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189157|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189158|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189159|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189160|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189161|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189162|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189163|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189164|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189165|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189166|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189167|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189168|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189169|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189170|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189171|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189172|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189173|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189174|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189175|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189176|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189177|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189178|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189179|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189180|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189181|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189182|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1189183|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1189184|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1189185|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189186|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189187|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189188|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189189|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190850|NCT00326001|O2|Outcome|Pt-Ir Tip Catheter|Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
1189190|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189191|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189192|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189193|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189194|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189195|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189196|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189197|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189198|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189199|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189200|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189201|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189202|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189203|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189204|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189205|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189206|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189207|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189208|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189209|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1189210|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1189211|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1189212|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189213|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189214|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189215|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189216|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189217|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189218|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189219|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189220|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189221|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189222|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189223|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189224|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189225|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189226|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189227|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190851|NCT00326001|O1|Outcome|Gold Tip Catheter|Patients allocated to be ablated by 8-mm gold tip catheter
1189228|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189229|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189230|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189231|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189232|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189233|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189234|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189235|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189238|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1189239|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189240|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189241|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189242|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189243|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189244|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189245|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189246|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189247|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189248|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189249|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189250|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189251|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189252|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189253|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189254|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189255|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189256|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189257|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189258|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189259|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189260|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189261|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189262|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189263|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1189264|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1189265|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1189266|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1191416|NCT00324259|O1|Outcome|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
1189267|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189268|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189269|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189270|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189271|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189272|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189273|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189274|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189275|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1191316|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
1189276|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189277|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189278|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189279|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189280|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189281|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189282|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189283|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189284|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189285|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189286|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189287|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189288|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189289|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189290|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1189291|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1189292|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1189293|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189294|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189295|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189296|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189297|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189298|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189299|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189300|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189301|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189302|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189303|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189304|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190852|NCT00326001|O2|Outcome|Pt-Ir Tip Catheter|Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
1189305|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189306|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189307|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189308|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189309|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189310|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189311|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189312|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189313|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189314|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189315|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189316|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189317|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189318|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189319|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189320|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189321|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189322|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189323|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189324|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189325|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189326|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189327|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189328|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189329|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189330|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189331|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189332|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189333|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189334|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189335|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189336|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189337|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189338|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189339|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189340|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189341|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189342|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189343|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189344|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189345|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189346|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189347|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189348|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189349|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189350|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189351|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189352|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189353|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189354|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189355|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189356|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189357|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189358|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189359|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189360|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189361|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189362|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189363|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189364|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189365|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1189366|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1189367|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1189368|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189369|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189370|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189371|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189372|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189373|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189374|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189375|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189376|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189377|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189378|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189379|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189380|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190853|NCT00326001|O1|Outcome|Gold Tip Catheter|Patients allocated to be ablated by 8-mm gold tip catheter
1189381|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189382|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189383|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189384|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189385|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189386|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189387|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189388|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189389|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189390|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189391|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189392|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189393|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189394|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189395|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189396|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189397|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189398|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189399|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189400|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189401|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189402|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189403|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189404|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189405|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189406|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189407|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189408|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189409|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189410|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189411|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189412|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189413|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189414|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189415|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189416|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189417|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189418|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189419|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189420|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189421|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189422|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189423|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189424|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189425|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189426|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189427|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189428|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189429|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189430|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189431|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189432|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189433|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189434|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189435|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189436|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189437|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189438|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189439|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189440|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1189441|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1189442|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1189443|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189444|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189445|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189446|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189447|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189448|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189449|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189450|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189451|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189452|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189453|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189454|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189455|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189456|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190854|NCT00326001|O2|Outcome|Pt-Ir Tip Catheter|Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
1189457|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189458|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189459|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189460|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189461|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189462|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189463|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189464|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189465|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189466|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189467|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189468|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189469|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189470|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189471|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189472|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189473|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189474|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189475|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189476|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189477|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189478|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189479|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189480|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189481|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189482|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189483|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189484|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189485|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189486|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189487|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189488|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189489|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189490|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189491|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189492|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189493|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189494|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189495|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189496|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189497|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189498|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189499|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189500|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189501|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189502|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189503|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189504|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189505|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189506|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189507|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189508|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189509|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189510|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189511|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189512|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189513|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189514|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189515|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1189516|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1189517|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1189518|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189519|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189520|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189521|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189522|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189523|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189524|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189525|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189526|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189527|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189528|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189529|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189530|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189531|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189532|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190855|NCT00326001|O1|Outcome|Gold Tip Catheter|Patients allocated to be ablated by 8-mm gold tip catheter
1189533|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189534|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189535|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189536|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189537|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189538|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189539|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189540|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189541|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189542|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189543|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189544|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189545|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189546|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189547|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189548|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189549|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189550|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189551|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189552|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189553|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189554|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189555|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189556|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189557|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189558|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189559|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189560|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189561|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189562|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189563|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189564|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189565|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189566|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189567|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189568|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189569|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189570|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189571|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189572|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189573|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189574|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189575|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189576|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189577|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189578|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189579|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189580|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189581|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189582|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189583|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189584|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189585|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189586|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189587|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189588|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189589|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189590|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1189591|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1189592|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1189593|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189594|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189595|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189596|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189597|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189598|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189599|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189600|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189601|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189602|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189603|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189604|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189605|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189606|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189607|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189608|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190856|NCT00326001|E2|Reported Event|Pt-Ir Tip Catheter|Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
1189609|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189610|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189611|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189612|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189613|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189614|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189615|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189616|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189617|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189618|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189619|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189620|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189621|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189622|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189623|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189624|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189625|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189626|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189627|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189628|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189629|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189630|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189631|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189632|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189633|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189634|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189635|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189636|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189637|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189638|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189639|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189640|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189641|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189642|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189643|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189644|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189645|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189646|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189647|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189648|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189649|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189650|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189651|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189652|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189653|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189654|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189655|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189656|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189657|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189658|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189659|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189660|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189661|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189662|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189663|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189664|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189665|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1189666|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1189667|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1189668|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189669|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189670|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189671|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189672|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189673|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189674|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189675|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189676|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189677|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189678|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189679|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189680|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189681|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189682|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189683|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189684|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190857|NCT00326001|E1|Reported Event|Gold Tip Catheter|Patients allocated to be ablated by 8-mm gold tip catheter
1189685|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189686|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189687|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189688|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189689|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189690|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189691|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189692|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189693|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189694|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189695|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189696|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189697|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189698|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189699|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189700|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189701|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189702|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189703|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189704|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189705|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189706|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189707|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189708|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189709|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189710|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189711|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189712|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189713|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189714|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189715|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189716|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189717|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189718|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189719|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189720|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189721|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189722|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189723|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189724|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189725|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189726|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189727|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189728|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189729|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189730|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189731|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189732|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189733|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189734|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189735|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189736|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189737|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189738|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189739|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189740|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1189741|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1189742|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1189743|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189744|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189745|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189746|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189747|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189748|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189749|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189750|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189751|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189752|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189753|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189754|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189755|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189756|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189757|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189758|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189759|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189760|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190858|NCT00325897|B3|Baseline|Total|Total of all reporting groups
1190859|NCT00325897|B2|Baseline|Placebo|Inactive sugar pill
1189761|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189762|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189763|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189764|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189765|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189766|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189767|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189768|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189769|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189770|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189771|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189772|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189773|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189774|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189775|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189776|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189777|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189778|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189779|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189780|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189781|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189782|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189783|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189784|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189785|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189786|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189787|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189788|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189789|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189790|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189791|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189792|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189793|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189794|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189795|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189796|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189797|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189798|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189799|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189800|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189801|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189802|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189803|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189804|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189805|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189806|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189807|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189808|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189809|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189810|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189811|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189812|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189813|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189814|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189815|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1189816|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1189817|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1189818|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189819|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189820|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189821|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189822|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189823|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189824|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189825|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189826|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189827|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189828|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189829|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189830|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189831|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189832|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189833|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189834|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189835|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189836|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190860|NCT00325897|B1|Baseline|Azithromycin|Azithromycin, 250 mg
1190861|NCT00325897|P2|Participant Flow|Placebo|Inactive sugar pill
1189837|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189838|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189839|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189840|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189841|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189842|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189843|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189844|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189845|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189846|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189847|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189848|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189849|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189850|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189851|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189852|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189853|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189854|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189855|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189856|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189857|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189858|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189859|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189860|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189861|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189862|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189863|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189864|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189865|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189866|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189867|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189868|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189869|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189870|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189871|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189872|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189873|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189874|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189875|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189876|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189877|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189878|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189879|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189880|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189881|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189882|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189883|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189884|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189885|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189886|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189887|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189888|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189889|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189890|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1189891|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1189892|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1189893|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189894|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189895|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189896|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189897|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189898|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189899|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189900|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189901|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189902|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189903|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189904|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189905|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1189906|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1189907|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1189908|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189909|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189910|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189911|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189912|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189913|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190862|NCT00325897|P1|Participant Flow|Azithromycin|Azithromycin, 250 mg
1189914|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189915|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189916|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189917|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189918|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189919|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189920|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189921|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189922|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189923|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189924|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189925|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189926|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189927|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189928|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189929|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189930|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189931|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189932|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1189933|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1189934|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1189935|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189936|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189937|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189938|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189939|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189940|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189941|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189942|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189943|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189944|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189945|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189946|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189947|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1189948|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1189949|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1189950|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189951|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189952|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190863|NCT00325897|O2|Outcome|Placebo|"Inactive~Placebo: Placebo taken on a daily basis"
1189953|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189954|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189955|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189956|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189957|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189958|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189959|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189960|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189961|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189962|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1189963|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1189964|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1189965|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189966|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189967|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189968|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189969|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189970|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189971|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189972|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189973|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189974|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189975|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189976|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189977|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1189978|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1189979|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1189980|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189981|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189982|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189983|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189984|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189985|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189986|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189987|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189988|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1189989|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189990|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1189991|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1191417|NCT00324259|O2|Outcome|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
1189995|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189996|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189997|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1189998|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1189999|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190000|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190001|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190002|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190003|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190004|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190005|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190006|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190007|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1190008|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1190009|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1190010|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190011|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190012|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190013|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190014|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190015|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190016|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190017|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190018|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190019|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190020|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190021|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190022|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1190023|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1190024|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1190025|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190026|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190027|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190028|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190029|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190030|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190031|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190032|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190033|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1191418|NCT00324259|O1|Outcome|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
1190034|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190035|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190036|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190037|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1190038|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1190039|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1190040|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190041|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190042|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190235|NCT00328614|E2|Reported Event|Samarium-153 (0.5 mCi/kg)|Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
1190043|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190044|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190045|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190046|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190047|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190048|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190049|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190050|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190051|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190052|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190053|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190054|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190055|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190056|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190057|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190058|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190059|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190060|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190061|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190062|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190063|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190064|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190065|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190066|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190067|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190068|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190069|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190070|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190071|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1191007|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
1190072|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190073|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190074|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190075|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190076|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190077|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190078|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190079|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190080|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190081|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190082|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190083|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190084|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190085|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190086|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190087|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190088|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190089|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190090|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190091|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190092|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190093|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190094|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190095|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190096|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190097|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190098|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190099|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190100|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190101|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190102|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190103|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190104|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190105|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190106|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190107|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190108|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190109|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190110|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190111|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190112|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190113|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190114|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190115|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190116|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190117|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190118|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190119|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190120|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190121|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190122|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190123|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190124|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190125|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190126|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190127|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190128|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190129|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190130|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190131|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190132|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190133|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190134|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190135|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190136|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1190137|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1190138|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1190139|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190140|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190141|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45 mg|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190142|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190143|NCT00328627|O8|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190144|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190145|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190146|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190147|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1191008|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
1190148|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190149|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190150|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190151|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190152|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190153|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45 mg|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190154|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190155|NCT00328627|O8|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190156|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190157|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190158|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190159|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190160|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190161|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190162|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190163|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190164|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190165|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45 mg|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190166|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190167|NCT00328627|O8|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190168|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190169|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190170|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190171|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190172|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190173|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190174|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190175|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190176|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190177|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45 mg|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190178|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190179|NCT00328627|O8|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190180|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190181|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190182|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190183|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190184|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190223|NCT00328614|B1|Baseline|Samarium-153 (0.25 mCi/kg)|Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
1190185|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190186|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190187|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190188|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190189|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190190|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190191|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190192|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190193|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190194|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190195|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190196|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190197|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190198|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190199|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
1190200|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
1190201|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
1190202|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|"Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).~This combination group includes participants from the following three treatment arms:~Alogliptin 25 mg + Pioglitazone 15 mg~Alogliptin 25 mg + Pioglitazone 30 mg~Alogliptin 25 mg + Pioglitazone 45 mg"
1190203|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|"Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).~This combination group includes participants from the following three treatment arms:~Alogliptin 12.5 mg + Pioglitazone 15 mg~Alogliptin 12.5 mg + Pioglitazone 30 mg~Alogliptin 12.5 mg + Pioglitazone 45 mg"
1190204|NCT00328627|O1|Outcome|Pioglitazone Alone|"Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).~This combination group includes participants from the following three treatment arms:~Placebo + Pioglitazone 15 mg~Placebo + Pioglitazone 30 mg~Placebo + Pioglitazone 45 mg"
1190205|NCT00328627|E12|Reported Event|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190206|NCT00328627|E11|Reported Event|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190207|NCT00328627|E10|Reported Event|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
1190208|NCT00328627|E9|Reported Event|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190209|NCT00328627|E8|Reported Event|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190210|NCT00328627|E7|Reported Event|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
1190211|NCT00328627|E6|Reported Event|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190212|NCT00328627|E5|Reported Event|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190213|NCT00328627|E4|Reported Event|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
1190214|NCT00328627|E3|Reported Event|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190215|NCT00328627|E2|Reported Event|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190216|NCT00328627|E1|Reported Event|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
1190217|NCT00328614|B7|Baseline|Total|Total of all reporting groups
1190218|NCT00328614|B6|Baseline|Samarium-153 (2.0 mCi/kg)|Cohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
1190219|NCT00328614|B5|Baseline|Samarium-153 (1.5 mCi/kg)|Cohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
1190220|NCT00328614|B4|Baseline|Samarium-153 (1.0 mCi/kg)|Cohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
1190221|NCT00328614|B3|Baseline|Samarium-153 (0.75 mCi/kg)|Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
1190222|NCT00328614|B2|Baseline|Samarium-153 (0.5 mCi/kg)|Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
1190226|NCT00328614|P4|Participant Flow|Samarium-153 (1.0 mCi/kg)|Cohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
1190227|NCT00328614|P3|Participant Flow|Samarium-153 (0.75 mCi/kg)|Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
1190228|NCT00328614|P2|Participant Flow|Samarium-153 (0.5 mCi/kg)|Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
1190229|NCT00328614|P1|Participant Flow|Samarium-153 (0.25 mCi/kg)|Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
1190230|NCT00328614|O1|Outcome|Samarium-153|Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
1190231|NCT00328614|E6|Reported Event|Samarium-153 (2.0 mCi/kg)|Cohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
1190232|NCT00328614|E5|Reported Event|Samarium-153 (1.5 mCi/kg)|Cohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
1190233|NCT00328614|E4|Reported Event|Samarium-153 (1.0 mCi/kg)|Cohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
1190234|NCT00328614|E3|Reported Event|Samarium-153 (0.75 mCi/kg)|Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
1190236|NCT00328614|E1|Reported Event|Samarium-153 (0.25 mCi/kg)|Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
1190237|NCT00328562|B1|Baseline|Iressa and RT|"Iressa plus thoracic RT at the following dose levels:~Level 1: 42.0 Gy in 10 fractions of 4.2 Gy~Level 2: 50.4 Gy in 12 fractions of 4.2 Gy~Level 3: 63.0 Gy in 15 fractions of 4.2 Gy~ZD1839 (Iressa)~Thoracic Radiotherapy"
1190238|NCT00328562|P1|Participant Flow|Iressa and RT|"Iressa plus thoracic RT at the following dose levels:~Level 1: 42.0 Gy in 10 fractions of 4.2 Gy~Level 2: 50.4 Gy in 12 fractions of 4.2 Gy~Level 3: 63.0 Gy in 15 fractions of 4.2 Gy"
1190239|NCT00328562|O1|Outcome|Iressa and RT|"Iressa plus thoracic RT at the following dose levels:~Level 1: 42.0 Gy in 10 fractions of 4.2 Gy~Level 2: 50.4 Gy in 12 fractions of 4.2 Gy~Level 3: 63.0 Gy in 15 fractions of 4.2 Gy~ZD1839 (Iressa)~Thoracic Radiotherapy"
1190240|NCT00328562|O1|Outcome|Iressa and RT|"Iressa plus thoracic RT at the following dose levels:~Level 1: 42.0 Gy in 10 fractions of 4.2 Gy~Level 2: 50.4 Gy in 12 fractions of 4.2 Gy~Level 3: 63.0 Gy in 15 fractions of 4.2 Gy~ZD1839 (Iressa)~Thoracic Radiotherapy"
1190241|NCT00328562|O1|Outcome|Iressa and RT|"Iressa plus thoracic RT at the following dose levels:~Level 1: 42.0 Gy in 10 fractions of 4.2 Gy~Level 2: 50.4 Gy in 12 fractions of 4.2 Gy~Level 3: 63.0 Gy in 15 fractions of 4.2 Gy~ZD1839 (Iressa)~Thoracic Radiotherapy"
1190242|NCT00328562|O1|Outcome|Iressa and RT|"Iressa plus thoracic RT at the following dose levels:~Level 1: 42.0 Gy in 10 fractions of 4.2 Gy~Level 2: 50.4 Gy in 12 fractions of 4.2 Gy~Level 3: 63.0 Gy in 15 fractions of 4.2 Gy~ZD1839 (Iressa)~Thoracic Radiotherapy"
1190243|NCT00328562|E1|Reported Event|Iressa and RT|"Iressa plus thoracic RT at the following dose levels:~Level 1: 42.0 Gy in 10 fractions of 4.2 Gy~Level 2: 50.4 Gy in 12 fractions of 4.2 Gy~Level 3: 63.0 Gy in 15 fractions of 4.2 Gy~ZD1839 (Iressa)~Thoracic Radiotherapy"
1190244|NCT00328510|B3|Baseline|Total|Total of all reporting groups
1190245|NCT00328510|B2|Baseline|BrainLab Thermoplastic Mask|Participant undergoes SRT using the BrainLab thermoplastic mask to immobilize the participant's head during radiation therapy
1190246|NCT00328510|B1|Baseline|GTC Frame|Participant undergoes SRT using a GTC frame to immobilize the participant's heading during radiation therapy
1190247|NCT00328510|P2|Participant Flow|BrainLab Thermoplastic Mask|Participant undergoes SRT using the BrainLab thermoplastic mask to immobilize the participant's head during radiation therapy
1190248|NCT00328510|P1|Participant Flow|GTC Frame|Participant undergoes SRT using a GTC frame to immobilize the participant's heading during radiation therapy
1190249|NCT00328510|O2|Outcome|BrainLab Thermoplastic Mask|Participant undergoes SRT using the BrainLab thermoplastic mask to immobilize the participant's head during radiation therapy
1190250|NCT00328510|O1|Outcome|GTC Frame|Participant undergoes SRT using a GTC frame to immobilize the participant's heading during radiation therapy
1190251|NCT00328510|E2|Reported Event|BrainLab Thermoplastic Mask|Participant undergoes SRT using the BrainLab thermoplastic mask to immobilize the participant's head during radiation therapy
1190252|NCT00328510|E1|Reported Event|GTC Frame|Participant undergoes SRT using a GTC frame to immobilize the participant's heading during radiation therapy
1190253|NCT00328263|B3|Baseline|Total|Total of all reporting groups
1190254|NCT00328263|B2|Baseline|Placebo|98g/day of placebo (devoid of microorganisms)
1190255|NCT00328263|B1|Baseline|Bio-K+ CL1285|98g/day of Bio-K+ CL1285 containing 50 billion of live bacteria.
1190256|NCT00328263|P2|Participant Flow|Placebo|98g/day of placebo (devoid of microorganisms)
1190257|NCT00328263|P1|Participant Flow|Bio-K+ CL1285|98g/day of Bio-K+ CL1285 containing 50 billion of live bacteria.
1190258|NCT00328263|O2|Outcome|Placebo|98g/day of placebo (devoid of microorganisms)
1190259|NCT00328263|O1|Outcome|Bio-K+ CL1285|98g/day of Bio-K+ CL1285 containing 50 billion of live bacteria.
1190260|NCT00328263|E2|Reported Event|Placebo|98g/day of placebo (devoid of microorganisms)
1190261|NCT00328263|E1|Reported Event|Bio-K+ CL1285|98g/day of Bio-K+ CL1285 containing 50 billion of live bacteria.
1190262|NCT00328198|B1|Baseline|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
1190263|NCT00328198|P1|Participant Flow|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
1190264|NCT00328198|O1|Outcome|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
1195578|NCT00313144|O2|Outcome|>6 Months to ≤12 Months|
1190265|NCT00328198|O1|Outcome|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
1190266|NCT00328198|O1|Outcome|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
1190267|NCT00328198|O1|Outcome|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
1190268|NCT00328198|O1|Outcome|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
1190269|NCT00328198|O1|Outcome|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
1190270|NCT00328198|O1|Outcome|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
1190271|NCT00328198|E1|Reported Event|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
1190272|NCT00328172|B6|Baseline|Total|Total of all reporting groups
1190273|NCT00328172|B5|Baseline|Metformin|Patients randomized to receive treatment with metformin
1190274|NCT00328172|B4|Baseline|Linagliptin (BI 1356) 5.0 mg|Patients randomized to receive treatment with linagliptin 5.0 mg
1190275|NCT00328172|B3|Baseline|Linagliptin (BI 1356) 2.5 mg|Patients randomized to receive treatment with linagliptin 2.5 mg
1190276|NCT00328172|B2|Baseline|Linagliptin (BI 1356) 0.5 mg|Patients randomized to receive treatment with linagliptin 0.5 mg
1190277|NCT00328172|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
1190278|NCT00328172|P5|Participant Flow|Metformin|Patients randomized to receive treatment with metformin
1190279|NCT00328172|P4|Participant Flow|Linagliptin (BI 1356) 5.0 mg|Patients randomized to receive treatment with linagliptin 5.0 mg
1190280|NCT00328172|P3|Participant Flow|Linagliptin (BI 1356) 2.5 mg|Patients randomized to receive treatment with linagliptin 2.5 mg
1190281|NCT00328172|P2|Participant Flow|Linagliptin (BI 1356) 0.5 mg|Patients randomized to receive treatment with linagliptin 0.5 mg
1190282|NCT00328172|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
1190283|NCT00328172|O5|Outcome|Metformin|Patients randomized to receive treatment with metformin
1190284|NCT00328172|O4|Outcome|Linagliptin (BI 1356) 5.0 mg|Patients randomized to receive treatment with linagliptin 5.0 mg
1190285|NCT00328172|O3|Outcome|Linagliptin (BI 1356) 2.5 mg|Patients randomized to receive treatment with linagliptin 2.5 mg
1190286|NCT00328172|O2|Outcome|Linagliptin (BI 1356) 0.5 mg|Patients randomized to receive treatment with linagliptin 0.5 mg
1190287|NCT00328172|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1190288|NCT00328172|O5|Outcome|Metformin|Patients randomized to receive treatment with metformin
1190289|NCT00328172|O4|Outcome|Linagliptin (BI 1356) 5.0 mg|Patients randomized to receive treatment with linagliptin 5.0 mg
1190290|NCT00328172|O3|Outcome|Linagliptin (BI 1356) 2.5 mg|Patients randomized to receive treatment with linagliptin 2.5 mg
1190291|NCT00328172|O2|Outcome|Linagliptin (BI 1356) 0.5 mg|Patients randomized to receive treatment with linagliptin 0.5 mg
1190292|NCT00328172|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1190293|NCT00328172|O5|Outcome|Metformin|Patients randomized to receive treatment with metformin
1190294|NCT00328172|O4|Outcome|Linagliptin (BI 1356) 5.0 mg|Patients randomized to receive treatment with linagliptin 5.0 mg
1190295|NCT00328172|O3|Outcome|Linagliptin (BI 1356) 2.5 mg|Patients randomized to receive treatment with linagliptin 2.5 mg
1190296|NCT00328172|O2|Outcome|Linagliptin (BI 1356) 0.5 mg|Patients randomized to receive treatment with linagliptin 0.5 mg
1190297|NCT00328172|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1190298|NCT00328172|E5|Reported Event|Metformin|Patients randomized to receive treatment with metformin
1190299|NCT00328172|E4|Reported Event|Linagliptin (BI 1356) 5.0 mg|Patients randomized to receive treatment with linagliptin 5.0 mg
1190300|NCT00328172|E3|Reported Event|Linagliptin (BI 1356) 2.5 mg|Patients randomized to receive treatment with linagliptin 2.5 mg
1190301|NCT00328172|E2|Reported Event|Linagliptin (BI 1356) 0.5 mg|Patients randomized to receive treatment with linagliptin 0.5 mg
1190302|NCT00328172|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
1190303|NCT00328094|B3|Baseline|Total|Total of all reporting groups
1190304|NCT00328094|B2|Baseline|Intermittent Insulin Bolus|Intermittent insulin boluses group
1190305|NCT00328094|B1|Baseline|Continuous Insulin Infusion|Tight glucose group with insulin infusion
1190306|NCT00328094|P2|Participant Flow|Intermittent Insulin Bolus|Intermittent insulin boluses group
1190307|NCT00328094|P1|Participant Flow|Continuous Insulin Infusion|Tight glucose group with insulin infusion
1190308|NCT00328094|O2|Outcome|Intermittent Insulin Bolus|Intermittent insulin boluses group
1190309|NCT00328094|O1|Outcome|Continuous Insulin Infusion|Tight glucose group with insulin infusion
1190310|NCT00328094|O2|Outcome|Intermittent Insulin Bolus|Intermittent insulin boluses group
1195579|NCT00313144|O1|Outcome|Baseline to ≤6 Months|
1190317|NCT00328042|P2|Participant Flow|Information Only|Information Only: This group receives a Hepatitis C Information Booklet and an HCV Resource Guide. The materials are designed for individual self-study.
1190318|NCT00328042|P1|Participant Flow|Self-Management Workshop|Self-Management Workshop: In addition to receiving HCV information materials to take home, the in-person 2.5 hour group workshop occurs weekly for six weeks.
1190319|NCT00328042|O2|Outcome|Information Only|Information Only: This group receives a Hepatitis C Information Booklet and an HCV Resource Guide. The materials are designed for individual self-study.
1190320|NCT00328042|O1|Outcome|Self-Management Workshop|Self-Management Workshop: In addition to receiving HCV information materials to take home, the in-person 2.5 hour group workshop occurs weekly for six weeks.
1190321|NCT00328042|O2|Outcome|Arm 2|Self-management self-study: This is an individual self-paced at home study program.
1190322|NCT00328042|O1|Outcome|Arm 1|Self-Management Workshop: The workshop is a once per week 2.5 hour group that meets for six weeks.
1190323|NCT00328042|E2|Reported Event|Information-Only|Information Only: This group receives a Hepatitis C Information Booklet and an HCV Resource Guide. The materials are designed for individual self-study.
1190324|NCT00328042|E1|Reported Event|Self-Management Workshop|Self-Management Workshop: In addition to receiving HCV information materials to take home, the in-person 2.5 hour group workshop occurs weekly for six weeks.
1190326|NCT00327717|B2|Baseline|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
1190327|NCT00327717|B1|Baseline|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
1190328|NCT00327717|P2|Participant Flow|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
1190329|NCT00327717|P1|Participant Flow|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
1190330|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
1190331|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
1190332|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
1190333|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
1190334|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
1190335|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
1190336|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
1190337|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
1190338|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
1190339|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
1190340|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
1190341|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
1190342|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
1190343|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
1190344|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
1190416|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
1190345|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
1190346|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
1190347|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
1190348|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
1190349|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
1191317|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
1190350|NCT00327717|E2|Reported Event|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
1190351|NCT00327717|E1|Reported Event|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
1190352|NCT00327470|B3|Baseline|Total|Total of all reporting groups
1190353|NCT00327470|B2|Baseline|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
1190354|NCT00327470|B1|Baseline|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
1190355|NCT00327470|P2|Participant Flow|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
1190356|NCT00327470|P1|Participant Flow|Early Age-related Macular Degeneration (AMD)|Subjects with early choroidal neovascularization (CNV) lesions were distinguished from subjects with established CNV lesions based on the stage of evolution of their CNV as determined by fluorescein angiography and, where available, indocyanine green angiography as assessed by the investigator at Baseline. Subjects with early CNV lesions were treated in the study eye with Macugen (0.3 milligram [mg]) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
1190357|NCT00327470|O2|Outcome|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
1190358|NCT00327470|O1|Outcome|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
1190359|NCT00327470|O2|Outcome|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
1190360|NCT00327470|O1|Outcome|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
1190361|NCT00327470|O2|Outcome|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
1190362|NCT00327470|O1|Outcome|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
1190387|NCT00327444|E1|Reported Event|Placebo|Participants with advanced ovarian cancer administered placebo intravenously, once every two weeks in the DB period and 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.
1195580|NCT00313144|O5|Outcome|>18 Months to ≤24 Months|
1190363|NCT00327470|O2|Outcome|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
1190364|NCT00327470|O1|Outcome|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
1190365|NCT00327470|O2|Outcome|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
1190423|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
1199142|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
1190366|NCT00327470|O1|Outcome|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
1190367|NCT00327470|O2|Outcome|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
1190368|NCT00327470|O1|Outcome|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
1190369|NCT00327470|O2|Outcome|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
1190370|NCT00327470|O1|Outcome|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
1190371|NCT00327470|E2|Reported Event|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
1190372|NCT00327470|E1|Reported Event|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
1190373|NCT00327444|B3|Baseline|Total|Total of all reporting groups
1190374|NCT00327444|B2|Baseline|Aflibercept|Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period and the OL period.
1190375|NCT00327444|B1|Baseline|Placebo|Participants with advanced ovarian cancer administered placebo intravenously, once every two weeks in the DB period and 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.
1190376|NCT00327444|P2|Participant Flow|Aflibercept|Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period and the OL period.
1190377|NCT00327444|P1|Participant Flow|Placebo|Participants with advanced ovarian cancer administered placebo intravenously, once every two weeks in the DB period and 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.
1190378|NCT00327444|O2|Outcome|Open-Label (OL) Period|Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.
1190379|NCT00327444|O1|Outcome|Double Blind (DB) Period|Participants with advanced ovarian cancer administered placebo or 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period.
1190380|NCT00327444|O2|Outcome|Aflibercept|Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period and the OL period.
1190381|NCT00327444|O1|Outcome|Placebo|Participants with advanced ovarian cancer administered placebo intravenously, once every two weeks in the DB period and 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.
1190382|NCT00327444|O2|Outcome|Aflibercept|Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period and the OL period.
1190383|NCT00327444|O1|Outcome|Placebo|Participants with advanced ovarian cancer administered placebo intravenously, once every two weeks in the DB period and 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.
1190384|NCT00327444|O2|Outcome|Aflibercept|Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period and the OL period.
1190385|NCT00327444|O1|Outcome|Placebo|Participants with advanced ovarian cancer administered placebo intravenously, once every two weeks in the DB period and 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.
1190386|NCT00327444|E2|Reported Event|Aflibercept|Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period and the OL period.
1190388|NCT00327392|B1|Baseline|Fospropofol Disodium|Fospropofol disodium 6.5 mg/kg (no less than 390 mg and no more than 585 mg, based on age, weight, and American Society of Anesthesiologists [ASA] Status): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 1.63 mg/kg (no less than 97.5 mg and no more than 146 mg) were administered as needed.
1190389|NCT00327392|P1|Participant Flow|Fospropofol Disodium|Fospropofol disodium 6.5 mg/kg (no less than 390 mg and no more than 585 mg, based on age, weight, and American Society of Anesthesiologists [ASA] Status): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 1.63 mg/kg (no less than 97.5 mg and no more than 146 mg) were administered as needed.
1190390|NCT00327392|O1|Outcome|Fospropofol Disodium|Fospropofol disodium 6.5 mg/kg (no less than 390 mg and no more than 585 mg, based on age, weight, and American Society of Anesthesiologists [ASA] Status): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 1.63 mg/kg (no less than 97.5 mg and no more than 146 mg) were administered as needed.
1190424|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
1190391|NCT00327392|E1|Reported Event|Fospropofol Disodium|Fospropofol disodium 6.5 mg/kg (no less than 390 mg and no more than 585 mg, based on age, weight, and American Society of Anesthesiologists [ASA] Status): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 1.63 mg/kg (no less than 97.5 mg and no more than 146 mg) were administered as needed.
1190392|NCT00327340|B3|Baseline|Total|Total of all reporting groups
1190393|NCT00327340|B2|Baseline|OGX-011 / Docetaxel/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and -3 of cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Docetaxel was infused at a dose of 75 mg/m² over 60 minutes on day 1 of each cycle.
1190394|NCT00327340|B1|Baseline|OGX-011 / Mitoxantrone/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and-3 of cycle 1 (Pretreatment loading doses). OGX-011 was then infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone was infused at a dose of 12 mg/m² over 30 minutes on day 1 of each cycle.
1190395|NCT00327340|P2|Participant Flow|OGX-011 / Docetaxel/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and -3 of cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Docetaxel was infused at a dose of 75 mg/m² over 60 minutes on day 1 of each cycle.
1190396|NCT00327340|P1|Participant Flow|OGX-011 / Mitoxantrone/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and-3 of cycle 1 (Pretreatment loading doses). OGX-011 was then infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone was infused at a dose of 12 mg/m² over 30 minutes on day 1 of each cycle.
1190397|NCT00327340|O2|Outcome|OGX-011 + Docetaxel + Prednisone|custirsen (OGX-011) in combination with docetaxel and prednisone
1190398|NCT00327340|O1|Outcome|OGX-011 + Mitoxantrone + Prednisone|custirsen (OGX-011) in combination with mitoxantrone and prednisone
1190399|NCT00327340|O2|Outcome|OGX-011 + Docetaxel + Prednisone|custirsen (OGX-011) in combination with docetaxel and prednisone
1190400|NCT00327340|O1|Outcome|OGX-011 + Mitoxantrone + Prednisone|custirsen (OGX-011) in combination with mitoxantrone and prednisone
1190401|NCT00327340|O2|Outcome|OGX-011 / Docetaxel/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and -3 of cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Docetaxel was infused at a dose of 75 mg/m² over 60 minutes on day 1 of each cycle.
1190402|NCT00327340|O1|Outcome|OGX-011 / Mitoxantrone/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and-3 of cycle 1 (Pretreatment loading doses). OGX-011 was then infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone was infused at a dose of 12 mg/m² over 30 minutes on day 1 of each cycle.
1190403|NCT00327340|O2|Outcome|OGX-011 + Docetaxel + Prednisone|custirsen (OGX-011) in combination with docetaxel and prednisone
1190404|NCT00327340|O1|Outcome|OGX-011 + Mitoxantrone + Prednisone|custirsen (OGX-011) in combination with mitoxantrone and prednisone
1190405|NCT00327340|E2|Reported Event|OGX-011 / Docetaxel/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and -3 of cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Docetaxel was infused at a dose of 75 mg/m² over 60 minutes on day 1 of each cycle.
1190406|NCT00327340|E1|Reported Event|OGX-011 / Mitoxantrone/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and-3 of cycle 1 (Pretreatment loading doses). OGX-011 was then infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone was infused at a dose of 12 mg/m² over 30 minutes on day 1 of each cycle.
1190407|NCT00327171|B3|Baseline|Total|Total of all reporting groups
1190408|NCT00327171|B2|Baseline|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
1190409|NCT00327171|B1|Baseline|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
1190410|NCT00327171|P2|Participant Flow|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
1190411|NCT00327171|P1|Participant Flow|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
1190412|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
1190413|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
1190414|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
1190415|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
1190417|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
1190418|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
1190419|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
1190420|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
1190421|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
1190422|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
1190425|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
1190426|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
1190427|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
1190428|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
1190429|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
1190430|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
1190431|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
1190432|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
1190433|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
1190434|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
1190435|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
1190436|NCT00327171|E2|Reported Event|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
1190437|NCT00327171|E1|Reported Event|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
1190438|NCT00327015|B5|Baseline|Total|Total of all reporting groups
1190439|NCT00327015|B4|Baseline|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
1190440|NCT00327015|B3|Baseline|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
1190441|NCT00327015|B2|Baseline|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
1190442|NCT00327015|B1|Baseline|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin Immediate Release (IR) was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
1190443|NCT00327015|P4|Participant Flow|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
1190444|NCT00327015|P3|Participant Flow|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
1190445|NCT00327015|P2|Participant Flow|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
1190446|NCT00327015|P1|Participant Flow|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin Immediate Release (IR) was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
1190447|NCT00327015|O3|Outcome|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
1190448|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
1190796|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
1190449|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
1190450|NCT00327015|O3|Outcome|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
1190451|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
1190452|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
1190689|NCT00326716|E2|Reported Event|Infant ATV 400 mg / RTV 100 mg|Infants of mothers taking ATV 400 mg / RTV 100 mg at birth.
1199143|NCT00301262|O2|Outcome|DB Placebo Baseline to < Week 8|
1190453|NCT00327015|O3|Outcome|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
1190454|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
1190455|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
1190456|NCT00327015|O3|Outcome|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
1190457|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
1190458|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
1190459|NCT00327015|O3|Outcome|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
1190460|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
1190461|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
1190462|NCT00327015|O3|Outcome|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
1190463|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
1190464|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
1190465|NCT00327015|O3|Outcome|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
1190466|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
1190467|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
1190468|NCT00327015|O3|Outcome|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
1190469|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
1190470|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
1190471|NCT00327015|O3|Outcome|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
1190472|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
1190473|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
1190474|NCT00327015|O3|Outcome|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
1190573|NCT00326898|O2|Outcome|Arm B (Sorafenib + Sunitinib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
1190475|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
1190476|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
1190477|NCT00327015|O3|Outcome|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
1190478|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
1190479|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
1190480|NCT00327015|O3|Outcome|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
1190481|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
1190482|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
1190483|NCT00327015|E4|Reported Event|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
1190484|NCT00327015|E3|Reported Event|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
1190485|NCT00327015|E2|Reported Event|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
1190486|NCT00327015|E1|Reported Event|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
1190487|NCT00326963|B1|Baseline|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
1190488|NCT00326963|P1|Participant Flow|Enfuvirtide+PI+ARV’s|Eligible participants received Fuzeon® (enfuvirtide) 90 milligram (mg) subcutaneously (SC) two times a day (bid) for 24 weeks plus new protease inhibitor (PI) (darunavir/ritonavir) plus other investigator-choice antiretrovirals (ARVs). Participants selected their preferred injection device among the following three options: 27 gauge (G) ½” needle/syringe, 31G 8 millimeter (mm) needle/syringe or Biojector 2000 (B2000) needle-free injection device (NFID).
1190489|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
1190490|NCT00326963|O1|Outcome|Enfuride+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
1190491|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
1190492|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
1190570|NCT00326898|P2|Participant Flow|Arm B (Sorafenib + Sunitinib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
1190493|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
1190494|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
1190574|NCT00326898|O1|Outcome|Arm A (Sunitinib + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
1190495|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
1190496|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
1190497|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
1190498|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
1190499|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
1190500|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
1190501|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
1190502|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
1190503|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
1190504|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
1190505|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
1190506|NCT00326963|E1|Reported Event|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
1190507|NCT00326950|B1|Baseline|E7389|E7389 will be administered intravenously on Days 1 and 8 of a 21-day cycle. Initial dose level will be 0.7 mg/m^2, with planned dose levels of 1.0, 1.4, & 2.0 mg/m^2.
1190508|NCT00326950|P1|Participant Flow|E7389|E7389 will be administered intravenously on Days 1 and 8 of a 21-day cycle. Initial dose level will be 0.7 mg/m^2, with planned dose levels of 1.0, 1.4, & 2.0 mg/m^2.
1190509|NCT00326950|O1|Outcome|E7389|E7389 will be administered intravenously on Days 1 and 8 of a 21 day cycle. The initial dose level will be 0.7 mg/m^2, with planned dose levels of 1.0, 1.4, 2.0 mg/m^2.
1190510|NCT00326950|O1|Outcome|E7389|E7389 will be administered intravenously on Days 1 and 8 of a 21 day cycle. The initial dose level will be 0.7 mg/m^2, with planned dose levels of 1.0, 1.4, 2.0 mg/m^2.
1190511|NCT00326950|E1|Reported Event|E7389|E7389 will be administered intravenously on Days 1 and 8 of a 21-day cycle. Initial dose level will be 0.7 mg/m^2, with planned dose levels of 1.0, 1.4, & 2.0 mg/m^2.
1190512|NCT00326911|B3|Baseline|Total|Total of all reporting groups
1190513|NCT00326911|B2|Baseline|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190514|NCT00326911|B1|Baseline|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190797|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
1195581|NCT00313144|O4|Outcome|>12 Months to ≤18 Months|
1190515|NCT00326911|P2|Participant Flow|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190690|NCT00326716|E1|Reported Event|Infant ATV 300 mg / RTV 100 mg|Infants of mothers taking ATV 300 mg / RTV 100 mg at birth.
1190516|NCT00326911|P1|Participant Flow|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190517|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190518|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190519|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190520|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190521|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190522|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190523|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190524|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190525|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190526|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190527|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190571|NCT00326898|P1|Participant Flow|Arm A (Sunitinib + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
1190575|NCT00326898|O3|Outcome|Arm C (Sunitinib Placebo + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
1190691|NCT00326612|B3|Baseline|Total|Total of all reporting groups
1190692|NCT00326612|B2|Baseline|Rectal Diazepam|0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
1190528|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190529|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190530|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190531|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190532|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190533|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190534|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190535|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190536|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190537|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190538|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190539|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190540|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190798|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
1190541|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190542|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190543|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190544|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190545|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190546|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190547|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190548|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190549|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190550|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190551|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190552|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190553|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190572|NCT00326898|O3|Outcome|Arm C (Sunitinib Placebo + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
1190554|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190555|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190556|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190557|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190558|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190559|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190560|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190561|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190562|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190563|NCT00326911|E2|Reported Event|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190564|NCT00326911|E1|Reported Event|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
1190565|NCT00326898|B4|Baseline|Total|Total of all reporting groups
1190566|NCT00326898|B3|Baseline|Arm C (Sunitinib Placebo + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
1190567|NCT00326898|B2|Baseline|Arm B (Sorafenib + Sunitinib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
1190568|NCT00326898|B1|Baseline|Arm A (Sunitinib + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
1190569|NCT00326898|P3|Participant Flow|Arm C (Sunitinib Placebo + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
1190799|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
1190576|NCT00326898|O2|Outcome|Arm B (Sorafenib + Sunitinib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
1190577|NCT00326898|O1|Outcome|Arm A (Sunitinib + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
1190578|NCT00326898|O3|Outcome|Arm C (Sunitinib Placebo + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
1190579|NCT00326898|O2|Outcome|Arm B (Sorafenib + Sunitinib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
1190580|NCT00326898|O1|Outcome|Arm A (Sunitinib + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
1190581|NCT00326898|O3|Outcome|Arm C (Sunitinib Placebo + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
1190582|NCT00326898|O2|Outcome|Arm B (Sorafenib + Sunitinib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
1190583|NCT00326898|O1|Outcome|Arm A (Sunitinib + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
1190584|NCT00326898|E3|Reported Event|Arm C (Sunitinib Placebo + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
1190585|NCT00326898|E2|Reported Event|Arm B (Sorafenib + Sunitinib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
1190586|NCT00326898|E1|Reported Event|Arm A (Sunitinib + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
1190587|NCT00326885|B1|Baseline|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
1190588|NCT00326885|P1|Participant Flow|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
1190589|NCT00326885|O1|Outcome|Full Analysis Set|
1190590|NCT00326885|O1|Outcome|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
1190591|NCT00326885|O1|Outcome|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
1190592|NCT00326885|O1|Outcome|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
1190593|NCT00326885|O1|Outcome|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
1190594|NCT00326885|O1|Outcome|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
1190595|NCT00326885|E1|Reported Event|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
1190596|NCT00326872|B1|Baseline|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
1190597|NCT00326872|P1|Participant Flow|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
1190724|NCT00326599|O2|Outcome|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
1190598|NCT00326872|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
1190599|NCT00326872|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
1190600|NCT00326872|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
1190601|NCT00326872|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
1190602|NCT00326872|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
1190603|NCT00326872|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
1190604|NCT00326872|E1|Reported Event|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
1190605|NCT00326781|B3|Baseline|Total|Total of all reporting groups
1190606|NCT00326781|B2|Baseline|Nicotine Nasal Spray|Half of all participants received nicotine nasal spray. 8 weeks of self-administered nicotine nasal spray @ 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette.
1190607|NCT00326781|B1|Baseline|Transdermal Nicotine|Half of randomized participants received 8-weeks of transdermal nicotine (Nicoderm CQ). The dosing schedule was as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours.
1190608|NCT00326781|P2|Participant Flow|Nicotine Nasal Spray|Half of all participants received nicotine nasal spray. 8 weeks of self-administered nicotine nasal spray @ 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette.
1190609|NCT00326781|P1|Participant Flow|Transdermal Nicotine|Half of randomized participants received 8-weeks of transdermal nicotine (Nicoderm CQ). The dosing schedule was as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours.
1190610|NCT00326781|O2|Outcome|Nicotine Nasal Spray|Half of all participants received nicotine nasal spray. 8 weeks of self-administered nicotine nasal spray @ 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette.
1190611|NCT00326781|O1|Outcome|Transdermal Nicotine|Half of randomized participants received 8-weeks of transdermal nicotine (Nicoderm CQ). The dosing schedule was as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours.
1190612|NCT00326781|O2|Outcome|Nicotine Nasal Spray|Half of all participants received nicotine nasal spray. 8 weeks of self-administered nicotine nasal spray @ 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette.
1190613|NCT00326781|O1|Outcome|Transdermal Nicotine|Half of randomized participants received 8-weeks of transdermal nicotine (Nicoderm CQ). The dosing schedule was as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours.
1190614|NCT00326781|E2|Reported Event|Nicotine Nasal Spray|Half of all participants received nicotine nasal spray. 8 weeks of self-administered nicotine nasal spray @ 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette.
1190615|NCT00326781|E1|Reported Event|Transdermal Nicotine|Half of randomized participants received 8-weeks of transdermal nicotine (Nicoderm CQ). The dosing schedule was as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours.
1190616|NCT00326716|B3|Baseline|Total|Total of all reporting groups
1190617|NCT00326716|B2|Baseline|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190618|NCT00326716|B1|Baseline|Mother ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190619|NCT00326716|P4|Participant Flow|Infants ATV 400 mg / RTV 100 mg|Infants born to mothers receiving treatment with ATV 400 mg / RTV 100 mg during the third trimester of pregnancy.
1190620|NCT00326716|P3|Participant Flow|Infants ATV 300 mg / RTV 100 mg|Infants born to mothers receiving treatment with ATV 300 mg / RTV 100 mg during the third trimester of pregnancy.
1190621|NCT00326716|P2|Participant Flow|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190622|NCT00326716|P1|Participant Flow|Mother ATV 300 mg / RTV 100 mg|Mothers receiving atazanavir (ATV) / ritonavir (RTV) 300/100 mg once daily (QD) + lamivudine (ZDV) / zidovudine (3TC) 300/150 mg twice daily (BID) during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190623|NCT00326716|O3|Outcome|Mothers ATV 400 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190624|NCT00326716|O2|Outcome|Mothers ATV 300 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190625|NCT00326716|O1|Outcome|Mothers ATV 300 mg / 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190626|NCT00326716|O3|Outcome|Mothers ATV 400 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190627|NCT00326716|O2|Outcome|Mothers ATV 300 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190628|NCT00326716|O1|Outcome|Mothers ATV 300 mg / 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190629|NCT00326716|O3|Outcome|Mothers ATV 400 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190630|NCT00326716|O2|Outcome|Mothers ATV 300 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190631|NCT00326716|O1|Outcome|Mothers ATV 300 mg / 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190632|NCT00326716|O2|Outcome|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190633|NCT00326716|O1|Outcome|Mother ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190634|NCT00326716|O2|Outcome|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190635|NCT00326716|O1|Outcome|Mother ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190636|NCT00326716|O2|Outcome|Infant ATV 400 mg / RTV 100 mg|Infansts of mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190637|NCT00326716|O1|Outcome|Infant ATV 300 mg / RTV 100 mg|Infants of mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190638|NCT00326716|O2|Outcome|Mothers ATV 400 mg / RTV 100 mg|Infants born to mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID at the time of delivery. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190639|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID at the time of delivery. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190640|NCT00326716|O3|Outcome|Mothers ATV 400 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190787|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
1190788|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
1190641|NCT00326716|O2|Outcome|Mothers ATV 300 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190642|NCT00326716|O1|Outcome|Mothers ATV 300 mg / 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1199144|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
1190643|NCT00326716|O3|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190644|NCT00326716|O2|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190645|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg once daily (QD) + ZDV/3TC 300/150 mg twice daily (BID) during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190646|NCT00326716|O3|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190647|NCT00326716|O2|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190648|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg once daily (QD) + ZDV/3TC 300/150 mg twice daily (BID) during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190649|NCT00326716|O3|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190650|NCT00326716|O2|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190651|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg once daily (QD) + ZDV/3TC 300/150 mg twice daily (BID) during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190652|NCT00326716|O3|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190653|NCT00326716|O2|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190654|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg once daily (QD) + ZDV/3TC 300/150 mg twice daily (BID) during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190655|NCT00326716|O3|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190656|NCT00326716|O2|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190657|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg once daily (QD) + ZDV/3TC 300/150 mg twice daily (BID) during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190658|NCT00326716|O3|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190659|NCT00326716|O2|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190660|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg once daily (QD) + ZDV/3TC 300/150 mg twice daily (BID) during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190661|NCT00326716|O2|Outcome|Mothers ATV 400 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190662|NCT00326716|O1|Outcome|Mothers ATV 300 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190663|NCT00326716|O2|Outcome|Mothers ATV 400 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190664|NCT00326716|O1|Outcome|Mothers ATV 300 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190665|NCT00326716|O2|Outcome|Mothers ATV 400 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190666|NCT00326716|O1|Outcome|Mothers ATV 300 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190667|NCT00326716|O2|Outcome|Infant ATV 400 mg / RTV 100 mg|Infants of mothers taking ATV 400 mg / RTV 100 mg at birth.
1190668|NCT00326716|O1|Outcome|Infant ATV 300 mg / RTV 100 mg|Infants of mothers taking ATV 300 mg / RTV 100 mg at birth.
1190669|NCT00326716|O2|Outcome|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190670|NCT00326716|O1|Outcome|Mother ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190671|NCT00326716|O2|Outcome|All Infants|Data are pooled for infants in the ATV 300 mg / RTV 100 mg and the ATV 400 mg / 100 mg groups.
1190672|NCT00326716|O1|Outcome|All Treated Mothers|Data are pooled for mothers in the ATV 300 mg / RTV 100 mg and the ATV 400 mg / 100 mg groups.
1190673|NCT00326716|O2|Outcome|All Infants|Data are pooled for infants in the ATV 300 mg / RTV 100 mg and the ATV 400 mg / 100 mg groups.
1190674|NCT00326716|O1|Outcome|All Treated Mothers|Data are pooled for mothers in the ATV 300 mg / RTV 100 mg and the ATV 400 mg / 100 mg groups.
1190675|NCT00326716|O2|Outcome|Infant ATV 400 mg / RTV 100 mg|
1190676|NCT00326716|O1|Outcome|Infant ATV 300 mg / RTV 100 mg|
1190677|NCT00326716|O2|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190678|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190679|NCT00326716|O2|Outcome|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190680|NCT00326716|O1|Outcome|Mother ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190681|NCT00326716|O2|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190682|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190683|NCT00326716|O2|Outcome|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190684|NCT00326716|O1|Outcome|Mother ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190685|NCT00326716|O2|Outcome|Mothers ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190686|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190687|NCT00326716|E4|Reported Event|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190688|NCT00326716|E3|Reported Event|Mother ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
1190693|NCT00326612|B1|Baseline|Intranasal Midazolam|0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
1190694|NCT00326612|P2|Participant Flow|Rectal Diazepam|0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
1190695|NCT00326612|P1|Participant Flow|Intranasal Midazolam|0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
1190696|NCT00326612|O2|Outcome|Rectal Diazepam|Includes intubation
1190697|NCT00326612|O1|Outcome|Intranasal Midazolam|Patients who required oxygen at discharge from the Emergency Department
1190698|NCT00326612|O2|Outcome|Rectal Diazepam|0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
1190699|NCT00326612|O1|Outcome|Intranasal Midazolam|0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
1190700|NCT00326612|O2|Outcome|Rectal Diazepam|0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
1190701|NCT00326612|O1|Outcome|Intranasal Midazolam|0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
1190702|NCT00326612|O2|Outcome|Rectal Diazepam|0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
1190703|NCT00326612|O1|Outcome|Intranasal Midazolam|0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
1190704|NCT00326612|O2|Outcome|Rectal Diazepam|0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
1190705|NCT00326612|O1|Outcome|Intranasal Midazolam|0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
1190706|NCT00326612|O2|Outcome|Rectal Diazepam|Includes intubation
1190707|NCT00326612|O1|Outcome|Intranasal Midazolam|Patients who required oxygen at discharge from the Emergency Department
1190708|NCT00326612|O2|Outcome|Rectal Diazepam|Median time to seizure cessation from medication administration to seizures stop time.
1190709|NCT00326612|O1|Outcome|Intranasal Midazolam|Median time to seizure cessation from medication administration to seizures stop time.
1190710|NCT00326612|E2|Reported Event|Rectal Diazepam|0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
1190711|NCT00326612|E1|Reported Event|Intranasal Midazolam|0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
1190712|NCT00326599|B5|Baseline|Total|Total of all reporting groups
1190713|NCT00326599|B4|Baseline|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
1190714|NCT00326599|B3|Baseline|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
1190715|NCT00326599|B2|Baseline|Lead-in Phase: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
1190716|NCT00326599|B1|Baseline|Lead-in Phase: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 45mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
1190717|NCT00326599|P4|Participant Flow|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
1190718|NCT00326599|P3|Participant Flow|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
1190719|NCT00326599|P2|Participant Flow|Lead-in Phase: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
1190720|NCT00326599|P1|Participant Flow|Lead-in Phase: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 45mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
1190721|NCT00326599|O1|Outcome|Lead-in Phase: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 45mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
1190722|NCT00326599|O2|Outcome|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
1190723|NCT00326599|O1|Outcome|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
1190725|NCT00326599|O1|Outcome|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
1190726|NCT00326599|O2|Outcome|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
1190727|NCT00326599|O1|Outcome|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
1190909|NCT00325754|B1|Baseline|E-Cylinder|"22-lb E-cylinder towed on a cart~E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
1190728|NCT00326599|O2|Outcome|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
1190729|NCT00326599|O1|Outcome|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
1190730|NCT00326599|O2|Outcome|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
1190731|NCT00326599|O1|Outcome|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
1190732|NCT00326599|O2|Outcome|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
1190733|NCT00326599|O1|Outcome|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
1190734|NCT00326599|E4|Reported Event|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
1190735|NCT00326599|E3|Reported Event|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
1190736|NCT00326599|E2|Reported Event|Lead-in Phase: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
1190737|NCT00326599|E1|Reported Event|Lead-in Phase: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 45mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
1190738|NCT00326495|B1|Baseline|BAY 43-9006 & Cetuximab|"BAY 43-9006: Administered orally at a dose of 400 mg twice a day (BID)~BAY 43-9006: is a potent inhibitor of proto-oncogene c-Raf (c-raf), and wild-type and mutant proto-oncogene b-Raf (b-raf) in vitro.~Cetuximab will be given intravenously (IV) at a dose of 400 mg/m^2 initially as a loading dose on week 2, followed by 250 mg/m^2 weekly starting on week 3.~Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the epidermal growth factor receptor (epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 1 (HER1), c-ErbB) in normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha."
1190739|NCT00326495|P1|Participant Flow|BAY 43-9006 & Cetuximab|"BAY 43-9006: Administered orally at a dose of 400 mg twice a day (BID)~BAY 43-9006: is a potent inhibitor of proto-oncogene c-Raf (c-raf), and wild-type and mutant proto-oncogene b-Raf (b-raf) in vitro.~Cetuximab will be given intravenously (IV) at a dose of 400 mg/m^2 initially as a loading dose on week 2, followed by 250 mg/m^2 weekly starting on week 3.~Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the epidermal growth factor receptor (epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 1 (HER1), c-ErbB) in normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha."
1190740|NCT00326495|O1|Outcome|BAY 43-9006 & Cetuximab|"BAY 43-9006: Administered orally at a dose of 400 mg twice a day (BID)~BAY 43-9006: is a potent inhibitor of proto-oncogene c-Raf (c-raf), and wild-type and mutant proto-oncogene b-Raf (b-raf) in vitro.~Cetuximab will be given intravenously (IV) at a dose of 400 mg/m^2 initially as a loading dose on week 2, followed by 250 mg/m^2 weekly starting on week 3.~Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the epidermal growth factor receptor (epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 1 (HER1), c-ErbB) in normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha."
1190789|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
1190790|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
1190791|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
1190792|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
1190793|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
1190794|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
1190741|NCT00326495|O1|Outcome|BAY 43-9006 & Cetuximab|"BAY 43-9006: Administered orally at a dose of 400 mg twice a day (BID)~BAY 43-9006: is a potent inhibitor of proto-oncogene c-Raf (c-raf), and wild-type and mutant proto-oncogene b-Raf (b-raf) in vitro.~Cetuximab will be given intravenously (IV) at a dose of 400 mg/m^2 initially as a loading dose on week 2, followed by 250 mg/m^2 weekly starting on week 3.~Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the epidermal growth factor receptor (epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 1 (HER1), c-ErbB) in normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha."
1190866|NCT00325897|O1|Outcome|Azithromycin, 250 mg|"Macrolide Antibiotic (Azithromycin)~Macrolide Antibiotic (Azithromycin): Azithromycin (daily capsule, 250 mg for 12 months)"
1190742|NCT00326495|E1|Reported Event|BAY 43-9006 & Cetuximab|"BAY 43-9006: Administered orally at a dose of 400 mg twice a day (BID)~BAY 43-9006: is a potent inhibitor of proto-oncogene c-Raf (c-raf), and wild-type and mutant proto-oncogene b-Raf (b-raf) in vitro.~Cetuximab will be given intravenously (IV) at a dose of 400 mg/m^2 initially as a loading dose on week 2, followed by 250 mg/m^2 weekly starting on week 3.~Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the epidermal growth factor receptor (epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 1 (HER1), c-ErbB) in normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha."
1190743|NCT00326417|B3|Baseline|Total|Total of all reporting groups
1190744|NCT00326417|B2|Baseline|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
1190745|NCT00326417|B1|Baseline|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
1190746|NCT00326417|P4|Participant Flow|Fludarabine|Fludarabine only (no Cyclophosphamide administered)
1190747|NCT00326417|P3|Participant Flow|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
1190748|NCT00326417|P2|Participant Flow|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
1190749|NCT00326417|P1|Participant Flow|Cyclophosphamide 150mg|Fludarabine plus 150 mg/kg Cyclophosphamide (total dose)
1190750|NCT00326417|O2|Outcome|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
1190751|NCT00326417|O1|Outcome|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
1190752|NCT00326417|O2|Outcome|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
1190753|NCT00326417|O1|Outcome|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
1190754|NCT00326417|O2|Outcome|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
1190755|NCT00326417|O1|Outcome|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
1190756|NCT00326417|O2|Outcome|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
1190757|NCT00326417|O1|Outcome|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
1190758|NCT00326417|O2|Outcome|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
1190759|NCT00326417|O1|Outcome|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
1190760|NCT00326417|E4|Reported Event|Fludarabine|Fludarabine only (no Cyclophosphamide administered)
1190761|NCT00326417|E3|Reported Event|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
1190762|NCT00326417|E2|Reported Event|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
1190763|NCT00326417|E1|Reported Event|Cyclophosphamide 150mg|Fludarabine plus 150 mg/kg Cyclophosphamide (total dose)
1190764|NCT00326196|B3|Baseline|Total|Total of all reporting groups
1190765|NCT00326196|B2|Baseline|Coronary Artery Bypass Graft|Coronary artery bypass graft (CABG)
1190766|NCT00326196|B1|Baseline|Percutaneous Coronary Intervention|Percutaneous coronary intervention
1190767|NCT00326196|P2|Participant Flow|Coronary Artery Bypass Graft|Initial revascularization with Coronary artery bypass graft (CABG). Multiple arterial conduits for suitable target vessels will be encouraged in the surgical treatment.
1190768|NCT00326196|P1|Participant Flow|Percutaneous Coronary Intervention|"Initial revascularization with Percutaneous coronary intervention. Whenever possible, drug-eluting stents will be used in the percutaneous treatment. The use of multiple stents to achieve a complete revascularization will be encouraged in the PCI treatment"
1190769|NCT00326196|O2|Outcome|Coronary Artery Bypass Graft|Coronary artery bypass graft (CABG)
1190770|NCT00326196|O1|Outcome|Percutaneous Coronary Intervention|Percutaneous coronary intervention
1190771|NCT00326196|E2|Reported Event|Coronary Artery Bypass Graft|Coronary artery bypass graft (CABG)
1190772|NCT00326196|E1|Reported Event|Percutaneous Coronary Intervention|Percutaneous coronary intervention
1190773|NCT00326183|B3|Baseline|Total|Total of all reporting groups
1190774|NCT00326183|B2|Baseline|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
1190775|NCT00326183|B1|Baseline|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
1190776|NCT00326183|P2|Participant Flow|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
1190777|NCT00326183|P1|Participant Flow|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
1190778|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
1190779|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
1190780|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
1190781|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
1190782|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
1190783|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
1190784|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
1190785|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
1190786|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
1190800|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
1190801|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
1190802|NCT00326170|B1|Baseline|VPA + 5-aza + ATRA|Daily for 7 days, Valproic acid (VPA) starting dose 75 mg/m^2 subcutaneously in combination with 5-azacytidine (5-aza) 50 mg/kg orally; and all-trans retinoic acid (ATRA) 45 mg/m^2 orally daily (in two divided doses) for 5 days starting on day 3.
1190867|NCT00325897|O2|Outcome|Placebo|"Inactive~Placebo: Placebo taken on a daily basis"
1191022|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
1190803|NCT00326170|P1|Participant Flow|VPA + 5-aza + ATRA|Daily for 7 days, Valproic acid (VPA) starting dose 75 mg/m^2 subcutaneously in combination with 5-azacytidine (5-aza) 50 mg/kg orally; and all-trans retinoic acid (ATRA) 45 mg/m^2 orally daily (in two divided doses) for 5 days starting on day 3.
1190804|NCT00326170|O1|Outcome|VPA + 5-aza + ATRA|Daily for 7 days, Valproic acid (VPA) starting dose 75 mg/m^2 subcutaneously in combination with 5-azacytidine (5-aza) 50 mg/kg orally; and all-trans retinoic acid (ATRA) 45 mg/m^2 orally daily (in two divided doses) for 5 days starting on day 3.
1190805|NCT00326170|E1|Reported Event|VPA + 5-aza + ATRA|Daily for 7 days, Valproic acid (VPA) starting dose 75 mg/m^2 subcutaneously in combination with 5-azacytidine (5-aza) 50 mg/kg orally; and all-trans retinoic acid (ATRA) 45 mg/m^2 orally daily (in two divided doses) for 5 days starting on day 3.
1190806|NCT00326118|B3|Baseline|Total|Total of all reporting groups
1190807|NCT00326118|B2|Baseline|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190808|NCT00326118|B1|Baseline|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190809|NCT00326118|P2|Participant Flow|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190810|NCT00326118|P1|Participant Flow|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190811|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190812|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190813|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190814|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190815|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190816|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190817|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190818|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190819|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190820|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190821|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190822|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190846|NCT00326001|P2|Participant Flow|Pt-Ir Tip Catheter|Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
1190823|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190868|NCT00325897|O1|Outcome|Azithromycin, 250 mg|"Macrolide Antibiotic (Azithromycin)~Macrolide Antibiotic (Azithromycin): Azithromycin (daily capsule, 250 mg for 12 months)"
1190824|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190825|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190826|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190827|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190828|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190829|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190830|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190831|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190832|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190833|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm
1190834|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190835|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190836|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190837|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190838|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190839|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190840|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190841|NCT00326118|E2|Reported Event|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190842|NCT00326118|E1|Reported Event|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
1190843|NCT00326001|B3|Baseline|Total|Total of all reporting groups
1190844|NCT00326001|B2|Baseline|Pt-Ir Tip Catheter|Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
1190845|NCT00326001|B1|Baseline|Gold Tip Catheter|Patients allocated to be ablated by 8-mm gold tip catheter
1190864|NCT00325897|O1|Outcome|Azithromycin, 250 mg|"Macrolide Antibiotic (Azithromycin)~Macrolide Antibiotic (Azithromycin): Azithromycin (daily capsule, 250 mg for 12 months)"
1190865|NCT00325897|O2|Outcome|Placebo|"Inactive~Placebo: Placebo taken on a daily basis"
1190869|NCT00325897|O2|Outcome|Placebo|Inactive sugar pill
1190882|NCT00325819|P2|Participant Flow|Placebo|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. Children were to receive a maximum of five doses of the study medication and all doses were to be administered within 24 hours of vaccination. Parents were encouraged to take the bottle of study medication to the vaccination visit, and to give the first dose at that visit, after the child’s weight was assessed and within an hour before or after vaccination. Parents were instructed to give subsequent doses a minimum of four hours apart and to give the last dose of study medication no later than 24 hours after vaccination. Following the first dose, each subsequent dose was to be given no earlier than 4 hours following the previous dose. A maximum of five doses of study medication were to be given; the last dose no later than 24 hours after the study vaccination.
1190883|NCT00325819|P1|Participant Flow|Acetaminophen|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. Children were to receive a maximum of five doses of the study medication and all doses were to be administered within 24 hours of vaccination. Parents were encouraged to take the bottle of study medication to the vaccination visit, and to give the first dose at that visit, after the child’s weight was assessed and within an hour before or after vaccination. Parents were instructed to give subsequent doses a minimum of four hours apart and to give the last dose of study medication no later than 24 hours after vaccination. Following the first dose, each subsequent dose was to be given no earlier than 4 hours following the previous dose. A maximum of five doses of study medication were to be given; the last dose no later than 24 hours after the study vaccination. Study drug was formulated to provide 160 mg of acetaminophen per 5 cc dose.
1190884|NCT00325819|O2|Outcome|Placebo|Subjects who were randomized to receive placebo
1190885|NCT00325819|O1|Outcome|Acetaminophen|Subjects who were randomized to receive acetaminophen
1190886|NCT00325819|O2|Outcome|Placebo|Subjects who were randomized to receive placebo
1190887|NCT00325819|O1|Outcome|Acetaminophen|Subjects who were randomized to receive acetaminophen
1190888|NCT00325819|O2|Outcome|Placebo|Subjects who were randomized to receive placebo
1190889|NCT00325819|O1|Outcome|Acetaminophen|Subjects who were randomized to receive acetaminophen
1190890|NCT00325819|O2|Outcome|Placebo|Subjects who were randomized to receive placebo
1190891|NCT00325819|O1|Outcome|Acetaminophen|Subjects who were randomized to receive acetaminophen
1190892|NCT00325819|O2|Outcome|Placebo|Subjects who were randomized to receive placebo
1190893|NCT00325819|O1|Outcome|Acetaminophen|Subjects who were randomized to receive acetaminophen
1190894|NCT00325819|O2|Outcome|Placebo|Subjects who were randomized to receive placebo
1190895|NCT00325819|O1|Outcome|Acetaminophen|Subjects who were randomized to receive acetaminophen
1190896|NCT00325819|O2|Outcome|Placebo|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
1190897|NCT00325819|O1|Outcome|Acetaminophen|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
1190898|NCT00325819|O2|Outcome|Placebo|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
1190899|NCT00325819|O1|Outcome|Acetaminophen|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
1190900|NCT00325819|E2|Reported Event|Placebo|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. Children were to receive a maximum of five doses of the study medication and all doses were to be administered within 24 hours of vaccination. Parents were encouraged to take the bottle of study medication to the vaccination visit, and to give the first dose at that visit, after the child’s weight was assessed and within an hour before or after vaccination. Parents were instructed to give subsequent doses a minimum of four hours apart and to give the last dose of study medication no later than 24 hours after vaccination. Following the first dose, each subsequent dose was to be given no earlier than 4 hours following the previous dose. A maximum of five doses of study medication were to be given; the last dose no later than 24 hours after the study vaccination.
1190939|NCT00325468|B4|Baseline|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
1190940|NCT00325468|B3|Baseline|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
1190901|NCT00325819|E1|Reported Event|Acetaminophen|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. Children were to receive a maximum of five doses of the study medication and all doses were to be administered within 24 hours of vaccination. Parents were encouraged to take the bottle of study medication to the vaccination visit, and to give the first dose at that visit, after the child’s weight was assessed and within an hour before or after vaccination. Parents were instructed to give subsequent doses a minimum of four hours apart and to give the last dose of study medication no later than 24 hours after vaccination. Following the first dose, each subsequent dose was to be given no earlier than 4 hours following the previous dose. A maximum of five doses of study medication were to be given; the last dose no later than 24 hours after the study vaccination. Study drug was formulated to provide 160 mg of acetaminophen per 5 cc dose.
1190902|NCT00325780|B1|Baseline|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
1190903|NCT00325780|P1|Participant Flow|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
1190904|NCT00325780|O1|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
1190905|NCT00325780|O1|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
1190906|NCT00325780|E1|Reported Event|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
1190907|NCT00325754|B3|Baseline|Total|Total of all reporting groups
1190908|NCT00325754|B2|Baseline|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried~Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
1191318|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
1190910|NCT00325754|P2|Participant Flow|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried~Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
1190911|NCT00325754|P1|Participant Flow|E-Cylinder|"22-lb E-cylinder towed on a cart~E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
1190912|NCT00325754|O2|Outcome|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried~Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
1190913|NCT00325754|O1|Outcome|E-Cylinder|"22-lb E-cylinder towed on a cart~E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
1190914|NCT00325754|O2|Outcome|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried~Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
1190915|NCT00325754|O1|Outcome|E-Cylinder|"22-lb E-cylinder towed on a cart~E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
1190916|NCT00325754|O2|Outcome|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried~Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
1190917|NCT00325754|O1|Outcome|E-Cylinder|"22-lb E-cylinder towed on a cart~E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
1190918|NCT00325754|O2|Outcome|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried~Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
1190919|NCT00325754|O1|Outcome|E-Cylinder|"22-lb E-cylinder towed on a cart~E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
1190920|NCT00325754|O2|Outcome|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried~Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
1190921|NCT00325754|O1|Outcome|E-Cylinder|"22-lb E-cylinder towed on a cart~E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
1190922|NCT00325754|E2|Reported Event|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried~Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
1190923|NCT00325754|E1|Reported Event|E-Cylinder|"22-lb E-cylinder towed on a cart~E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
1190924|NCT00325598|B3|Baseline|Total|Total of all reporting groups
1190925|NCT00325598|B2|Baseline|Cohort 2 (40 Gy)|"40 Gy in 10 fractions BID over 5 treatment days~Partial Breast Irradiation (PBI)"
1190926|NCT00325598|B1|Baseline|Cohort 1 (36 Gy)|"36 Gy in 9 fractions BID x 4 1/2 treatment days~Partial Breast Irradiation (PBI)"
1190927|NCT00325598|P2|Participant Flow|Cohort 2 (40 Gy)|"40 Gy in 10 fractions BID over 5 treatment days~Partial Breast Irradiation (PBI)"
1190928|NCT00325598|P1|Participant Flow|Cohort 1 (36 Gy)|"36 Gy in 9 fractions BID x 4 1/2 treatment days~Partial Breast Irradiation (PBI)"
1190929|NCT00325598|O2|Outcome|Cohort 2 (40 Gy)|"40 Gy in 10 fractions BID over 5 treatment days~Partial Breast Irradiation (PBI)"
1190930|NCT00325598|O1|Outcome|Cohort 1 (36 Gy)|"36 Gy in 9 fractions BID x 4 1/2 treatment days~Partial Breast Irradiation (PBI)"
1190931|NCT00325598|O2|Outcome|Cohort 2 (40 Gy)|"40 Gy in 10 fractions BID over 5 treatment days~Partial Breast Irradiation (PBI)"
1190932|NCT00325598|O1|Outcome|Cohort 1 (36 Gy)|"36 Gy in 9 fractions BID x 4 1/2 treatment days~Partial Breast Irradiation (PBI)"
1190933|NCT00325598|E4|Reported Event|Cohort 2 (40 Gy) Late Toxicities|"40 Gy in 10 fractions BID over 5 treatment days~Partial Breast Irradiation (PBI)~Follow toxicities from Day 91 through end of follow-up"
1190934|NCT00325598|E3|Reported Event|Cohort 2 (40 Gy) Acute Toxicities|"40 Gy in 10 fractions BID over 5 treatment days~Partial Breast Irradiation (PBI)~Follow toxicities from Day 91 through end of follow-up"
1190935|NCT00325598|E2|Reported Event|Cohort 1 (36 Gy) Late Toxicities|"36 Gy in 9 fractions BID x 4 1/2 treatment days~Partial Breast Irradiation (PBI)~Follow toxicities from Day 1 through Day 90"
1190936|NCT00325598|E1|Reported Event|Cohort 1 (36 Gy) Acute Toxicities|"36 Gy in 9 fractions BID x 4 1/2 treatment days~Partial Breast Irradiation (PBI)~Follow toxicities from Day 1 through Day 90"
1190937|NCT00325468|B6|Baseline|Total|Total of all reporting groups
1190938|NCT00325468|B5|Baseline|Alendronate 70mg QW|In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
1191006|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
1191419|NCT00324259|O2|Outcome|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
1190941|NCT00325468|B2|Baseline|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
1190942|NCT00325468|B1|Baseline|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
1190943|NCT00325468|P5|Participant Flow|Alendronate 70mg QW|In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
1190944|NCT00325468|P4|Participant Flow|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
1190945|NCT00325468|P3|Participant Flow|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
1190946|NCT00325468|P2|Participant Flow|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
1191023|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
1190947|NCT00325468|P1|Participant Flow|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
1190948|NCT00325468|O5|Outcome|Alendronate 70mg QW|In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
1190949|NCT00325468|O4|Outcome|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
1190950|NCT00325468|O3|Outcome|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
1190951|NCT00325468|O2|Outcome|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
1190952|NCT00325468|O1|Outcome|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
1190953|NCT00325468|O5|Outcome|Alendronate 70mg QW|In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
1190954|NCT00325468|O4|Outcome|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
1190955|NCT00325468|O3|Outcome|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
1190956|NCT00325468|O2|Outcome|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
1190957|NCT00325468|O1|Outcome|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
1190958|NCT00325468|O5|Outcome|Alendronate 70mg QW|In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
1190959|NCT00325468|O4|Outcome|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
1190960|NCT00325468|O3|Outcome|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
1190961|NCT00325468|O2|Outcome|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
1190962|NCT00325468|O1|Outcome|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
1190963|NCT00325468|O5|Outcome|Alendronate 70mg QW|In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
1190964|NCT00325468|O4|Outcome|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
1190965|NCT00325468|O3|Outcome|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
1190966|NCT00325468|O2|Outcome|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
1190967|NCT00325468|O1|Outcome|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
1190968|NCT00325468|O5|Outcome|Alendronate 70mg QW|In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
1190969|NCT00325468|O4|Outcome|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
1190970|NCT00325468|O3|Outcome|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
1190971|NCT00325468|O2|Outcome|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
1190972|NCT00325468|O1|Outcome|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
1190973|NCT00325468|E6|Reported Event|All Participants|
1190974|NCT00325468|E5|Reported Event|Alendronate 70 mg QW|
1190975|NCT00325468|E4|Reported Event|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
1190976|NCT00325468|E3|Reported Event|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
1190977|NCT00325468|E2|Reported Event|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
1190978|NCT00325468|E1|Reported Event|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
1190979|NCT00325442|B3|Baseline|Total|Total of all reporting groups
1190980|NCT00325442|B2|Baseline|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
1190981|NCT00325442|B1|Baseline|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
1190982|NCT00325442|P2|Participant Flow|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
1190983|NCT00325442|P1|Participant Flow|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
1190984|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
1190985|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
1190986|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
1190987|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
1190988|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
1190989|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
1190990|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
1190991|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
1190992|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
1190993|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
1190994|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
1190995|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
1190996|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
1190997|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
1190998|NCT00325442|O3|Outcome|3.5 - 16 mg|Subjects in this group received 3.5 to 16 mg oral treprostinil twice daily.
1190999|NCT00325442|O2|Outcome|1.25 - 3.25 mg|Subjects in this group recieved 1.25 to 3.25 mg oral treprostinil twice daily.
1191000|NCT00325442|O1|Outcome|Less Than 1 mg or Discontinuation Due to Adverse Events|Subjects in this group received less than or equal to 1 mg oral treprostinil twice daily or discontinued treatment due to adverse events.
1191001|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
1191002|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
1191003|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
1191004|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
1191005|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
1191009|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
1191010|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
1191011|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
1191012|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
1191013|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
1191014|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
1191015|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
1191016|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
1191017|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
1191018|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
1191019|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
1191020|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
1191021|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
1191319|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
1191024|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
1191025|NCT00325442|E2|Reported Event|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
1191026|NCT00325442|E1|Reported Event|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
1191027|NCT00325416|B3|Baseline|Total|Total of all reporting groups
1191028|NCT00325416|B2|Baseline|Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
1191029|NCT00325416|B1|Baseline|Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 18 – 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
1191030|NCT00325416|P2|Participant Flow|Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
1191031|NCT00325416|P1|Participant Flow|Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 18 – 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
1191032|NCT00325416|O2|Outcome|Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
1191033|NCT00325416|O1|Outcome|Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 18 – 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
1191034|NCT00325416|O2|Outcome|Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
1191035|NCT00325416|O1|Outcome|Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 18 – 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
1191064|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
1191065|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
1191420|NCT00324259|O1|Outcome|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
1191036|NCT00325416|O2|Outcome|Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
1191037|NCT00325416|O1|Outcome|Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 18 – 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
1191038|NCT00325416|O2|Outcome|Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
1191074|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
1191075|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
1191039|NCT00325416|O1|Outcome|Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 18 – 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
1191040|NCT00325416|E2|Reported Event|Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
1191041|NCT00325416|E1|Reported Event|Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 18 – 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
1191042|NCT00325403|B3|Baseline|Total|Total of all reporting groups
1191043|NCT00325403|B2|Baseline|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population
1191044|NCT00325403|B1|Baseline|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
1191045|NCT00325403|P2|Participant Flow|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily (every 12 hours +/- 1 hour) and were included in the primary analysis population. Dose increases were made in the absence of dose-limiting drug-related AEs, to ensure the subject received the optimal clinical dose throughout the study.
1191046|NCT00325403|P1|Participant Flow|Placebo|These subjects were randomly allocated to receive matching oral placebo twice daily (every 12 hours +/- 1 hour) and were included in the primary analysis population. Dose increases were made in the absence of dose-limiting drug-related AEs, to ensure the subject received the optimal clinical dose throughout the study.
1191047|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily.
1191048|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily.
1191049|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily.
1191050|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily.
1191051|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily.
1191052|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily.
1191053|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily.
1191054|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily.
1191055|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
1191056|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
1191057|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
1191058|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
1191059|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
1191060|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
1191061|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
1191062|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
1191063|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
1195582|NCT00313144|O3|Outcome|>6 Months to ≤12 Months|
1191066|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
1191067|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
1191068|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
1191069|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
1191070|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
1191071|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
1191072|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
1191073|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
1191102|NCT00325195|B2|Baseline|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
1191076|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
1191077|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
1191078|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
1191079|NCT00325403|E2|Reported Event|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
1191080|NCT00325403|E1|Reported Event|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
1191081|NCT00325234|B3|Baseline|Total|Total of all reporting groups
1191082|NCT00325234|B2|Baseline|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.~Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
1191083|NCT00325234|B1|Baseline|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
1191084|NCT00325234|P2|Participant Flow|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.~Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
1191085|NCT00325234|P1|Participant Flow|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
1191086|NCT00325234|O2|Outcome|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.~Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
1191087|NCT00325234|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
1191088|NCT00325234|O2|Outcome|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.~Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
1191089|NCT00325234|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
1191090|NCT00325234|O2|Outcome|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.~Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
1191091|NCT00325234|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
1191092|NCT00325234|O2|Outcome|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.~Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
1191093|NCT00325234|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
1191094|NCT00325234|O2|Outcome|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.~Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
1191152|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191421|NCT00324259|E2|Reported Event|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
1191095|NCT00325234|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
1191096|NCT00325234|O2|Outcome|Gemcitabine/Vinorelbine|Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8. Gemcitabine 1200 mg/m^2 will be given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days.
1191097|NCT00325234|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0. The cycle of treatment was 21 days.
1191098|NCT00325234|E2|Reported Event|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.~Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
1191099|NCT00325234|E1|Reported Event|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
1191100|NCT00325195|B4|Baseline|Total|Total of all reporting groups
1191101|NCT00325195|B3|Baseline|Placebo|placebo infusion every 2 weeks
1191103|NCT00325195|B1|Baseline|q2 Wks|8 mg pegloticase every 2 weeks
1191105|NCT00325195|P2|Participant Flow|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
1191106|NCT00325195|P1|Participant Flow|q2 Wks|8 mg pegloticase every 2 weeks
1191107|NCT00325195|O3|Outcome|Placebo|placebo infusion every 2 weeks
1191108|NCT00325195|O2|Outcome|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
1191109|NCT00325195|O1|Outcome|q2 Wks|8 mg pegloticase every 2 weeks
1191110|NCT00325195|O3|Outcome|Placebo|placebo infusion every 2 weeks
1191111|NCT00325195|O2|Outcome|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
1191112|NCT00325195|O1|Outcome|q2 Wks|8 mg pegloticase every 2 weeks
1191113|NCT00325195|O3|Outcome|Placebo|placebo infusion every 2 weeks
1191114|NCT00325195|O2|Outcome|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
1191115|NCT00325195|O1|Outcome|q2 Wks|8 mg pegloticase every 2 weeks
1191116|NCT00325195|O3|Outcome|Placebo|placebo infusion every 2 weeks
1191117|NCT00325195|O2|Outcome|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
1191118|NCT00325195|O1|Outcome|q2 Wks|8 mg pegloticase every 2 weeks
1191119|NCT00325195|O3|Outcome|Placebo|placebo infusion every 2 weeks
1191120|NCT00325195|O2|Outcome|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
1191121|NCT00325195|O1|Outcome|q2 Wks|8 mg pegloticase every 2 weeks
1191122|NCT00325195|O3|Outcome|Placebo|placebo infusion every 2 weeks
1191123|NCT00325195|O2|Outcome|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
1191124|NCT00325195|O1|Outcome|q2 Wks|8 mg pegloticase every 2 weeks
1191125|NCT00325195|E3|Reported Event|Placebo|placebo infusion every 2 weeks
1191126|NCT00325195|E2|Reported Event|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
1191127|NCT00325195|E1|Reported Event|q2 Wks|8 mg pegloticase every 2 weeks
1191128|NCT00325156|B1|Baseline|Infanrix-IPV+ Hib Group|Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
1191129|NCT00325156|P1|Participant Flow|Infanrix-IPV+Hib Group|Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
1191130|NCT00325156|O1|Outcome|Infanrix-IPV+Hib Group|Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
1191131|NCT00325156|O1|Outcome|Infanrix-IPV+Hib Group|Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
1191132|NCT00325156|O1|Outcome|Infanrix-IPV+Hib Group|Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
1191153|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191133|NCT00325156|O1|Outcome|Infanrix-IPV+Hib Group|Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
1191134|NCT00325156|E1|Reported Event|Infanrix-IPV+Hib Group|Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
1191135|NCT00325143|B1|Baseline|Infanrix Hexa Group|Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028, additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally.
1191165|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191166|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191320|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
1191136|NCT00325143|P1|Participant Flow|Infanrix Hexa Group|Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028, additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally.
1191137|NCT00325143|O1|Outcome|Infanrix Hexa Group|Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028, additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally.
1191138|NCT00325143|O1|Outcome|Infanrix Hexa Group|Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028, additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally.
1191139|NCT00325143|O1|Outcome|Infanrix Hexa Group|Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028, additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally.
1191140|NCT00325143|O1|Outcome|Infanrix Hexa Group|Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028, additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally.
1191141|NCT00325143|E1|Reported Event|Infanrix Hexa Group|Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028, additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally.
1191142|NCT00325130|B3|Baseline|Total|Total of all reporting groups
1191143|NCT00325130|B2|Baseline|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191144|NCT00325130|B1|Baseline|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191145|NCT00325130|P2|Participant Flow|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191146|NCT00325130|P1|Participant Flow|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191147|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191148|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191149|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191150|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191151|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1195583|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
1191154|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191155|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191156|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191157|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191158|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191159|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191160|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191161|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191162|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191163|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191164|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191167|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191168|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191169|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191170|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191171|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191172|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191173|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191174|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191175|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191176|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191177|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191178|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191179|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191180|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191181|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191182|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191183|NCT00325130|E2|Reported Event|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191184|NCT00325130|E1|Reported Event|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
1191185|NCT00325078|B4|Baseline|Total|Total of all reporting groups
1191186|NCT00325078|B3|Baseline|Control Volunteer|Subjects who volunteer to participate in endoscopy and GI mucosal biopsies to provide controls for the study. The subjects in this arm may be healthy subjects, CGD subjects without GI symptoms, or subjects with Crohn’s disease (CD). The rate of infections in the CGD patients without IBD are monitored.
1191187|NCT00325078|B2|Baseline|Observation Group|CGD patients with IBD who are not treated with any study medication and are monitored for rate of infections.
1191188|NCT00325078|B1|Baseline|Treatment Group|"This group comprises patients with Chronic granulomatous disease (CGD) complicated by significant inflammatory bowel disease (IBD). The subjects are treated with a TNFa inhibitor at standard recommended doses for treatment of Crohn’s disease. Infliximab is administered as intravenous infusions at 5mg/kg on weeks 0, 2 and 6 for induction and every 6-8 weeks at 5-10mg/kg for maintenance. Adalimumab is administered at 160mg, 60mg, 40mg, 40mg on weeks 0, 2, 4 and 6 via subcutaneous injection.~Endoscopies and gastrointestinal mucosal biopsies are obtained before treatment, following induction, and again at completion of treatment."
1191189|NCT00325078|P3|Participant Flow|Control Volunteer|Subjects who volunteer to participate in endoscopy and GI mucosal biopsies to provide controls for the study. The subjects in this arm may be healthy subjects, CGD subjects without GI symptoms, or subjects with Crohn’s disease (CD). The rate of infections in the CGD patients without IBD are monitored.
1191190|NCT00325078|P2|Participant Flow|Observation Group|CGD patients with IBD who are not treated with any study medication and are monitored for rate of infections.
1191191|NCT00325078|P1|Participant Flow|Treatment Group|"This group comprises patients with Chronic granulomatous disease (CGD) complicated by significant inflammatory bowel disease (IBD). The subjects are treated with a TNFa inhibitor at standard recommended doses for treatment of Crohn’s disease. Infliximab is administered as intravenous infusions at 5mg/kg on weeks 0, 2 and 6 for induction and every 6-8 weeks at 5-10mg/kg for maintenance. Adalimumab is administered at 160mg, 60mg, 40mg, 40mg on weeks 0, 2, 4 and 6 via subcutaneous injection.~Endoscopies and gastrointestinal mucosal biopsies are obtained before treatment, following induction, and again at completion of treatment."
1191192|NCT00325078|O2|Outcome|Observation|CGD patients with IBD who are not treated with any study medication and are monitored for rate of infections.
1191193|NCT00325078|O1|Outcome|Treatment|"This group comprises patients with Chronic granulomatous disease (CGD) complicated by significant inflammatory bowel disease (IBD). The subjects are treated with a TNFa inhibitor at standard recommended doses for treatment of Crohn’s disease. Infliximab is administered as intravenous infusions at 5mg/kg on weeks 0, 2 and 6 for induction and every 6-8 weeks at 5-10mg/kg for maintenance. Adalimumab is administered at 160mg, 60mg, 40mg, 40mg on weeks 0, 2, 4 and 6 via subcutaneous injection.~Endoscopies and gastrointestinal mucosal biopsies are obtained before treatment, following induction, and again at completion of treatment."
1191194|NCT00325078|O3|Outcome|Control Volunteers|Subjects who volunteer to participate in endoscopy and GI mucosal biopsies to provide controls for the study. The subjects in this arm may be healthy subjects, CGD subjects without GI symptoms, or subjects with Crohn’s disease (CD). The rate of infections in the CGD patients without IBD are monitored.
1191195|NCT00325078|O2|Outcome|Observation|Subjects with IBD without TNFa inhibitor treatment
1191196|NCT00325078|O1|Outcome|Treatment|"This group comprises patients with Chronic granulomatous disease (CGD) complicated by significant inflammatory bowel disease (IBD). The subjects are treated with a TNFa inhibitor at standard recommended doses for treatment of Crohn’s disease. Infliximab is administered as intravenous infusions at 5mg/kg on weeks 0, 2 and 6 for induction and every 6-8 weeks at 5-10mg/kg for maintenance. Adalimumab is administered at 160mg, 60mg, 40mg, 40mg on weeks 0, 2, 4 and 6 via subcutaneous injection.~Endoscopies and gastrointestinal mucosal biopsies are obtained before treatment, following induction, and again at completion of treatment."
1191311|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
1191197|NCT00325078|E3|Reported Event|Control Volunteer|Subjects who volunteer to participate in endoscopy and GI mucosal biopsies to provide controls for the study. The subjects in this arm may be healthy subjects, CGD subjects without GI symptoms, or subjects with Crohn’s disease (CD). The rate of infections in the CGD patients without IBD are monitored.
1191198|NCT00325078|E2|Reported Event|Observation Group|CGD patients with IBD who are not treated with any study medication and are monitored for rate of infections.
1191199|NCT00325078|E1|Reported Event|Treatment Group|"This group comprises patients with Chronic granulomatous disease (CGD) complicated by significant inflammatory bowel disease (IBD). The subjects are treated with a TNFa inhibitor at standard recommended doses for treatment of Crohn’s disease. Infliximab is administered as intravenous infusions at 5mg/kg on weeks 0, 2 and 6 for induction and every 6-8 weeks at 5-10mg/kg for maintenance. Adalimumab is administered at 160mg, 60mg, 40mg, 40mg on weeks 0, 2, 4 and 6 via subcutaneous injection.~Endoscopies and gastrointestinal mucosal biopsies are obtained before treatment, following induction, and again at completion of treatment."
1191200|NCT00325039|B3|Baseline|Total|Total of all reporting groups
1191201|NCT00325039|B2|Baseline|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
1191202|NCT00325039|B1|Baseline|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
1191203|NCT00325039|P2|Participant Flow|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
1191204|NCT00325039|P1|Participant Flow|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
1191205|NCT00325039|O2|Outcome|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
1191206|NCT00325039|O1|Outcome|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
1191207|NCT00325039|O2|Outcome|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
1191208|NCT00325039|O1|Outcome|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
1191209|NCT00325039|O2|Outcome|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
1191210|NCT00325039|O1|Outcome|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
1191211|NCT00325039|O2|Outcome|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
1191212|NCT00325039|O1|Outcome|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
1191213|NCT00325039|O2|Outcome|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
1191214|NCT00325039|O1|Outcome|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
1191215|NCT00325039|E2|Reported Event|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
1191216|NCT00325039|E1|Reported Event|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
1191217|NCT00324961|B1|Baseline|10 mg Adefovir Dipivoxil (ADV)|10 mg ADV tablets once daily for 104 weeks
1191218|NCT00324961|P1|Participant Flow|10 mg Adefovir Dipivoxil (ADV)|10 mg ADV tablets once daily for 104 weeks
1191219|NCT00324961|O1|Outcome|10 mg Adefovir Dipivoxil (ADV)|10 mg ADV tablets once daily for 104 weeks
1191220|NCT00324961|O1|Outcome|10 mg Adefovir Dipivoxil (ADV|10 mg ADV tablets once daily for 104 weeks
1191221|NCT00324961|O1|Outcome|HBeAg- at Baseline|All participants who were Hepatitis B e Antigen (HBeAg) negative at baseline
1191222|NCT00324961|O1|Outcome|10 mg Adefovir Dipivoxil (ADV)|10 mg ADV tablets once daily for 104 weeks
1191223|NCT00324961|O1|Outcome|HBeAg- at Baseline|All participants who were Hepatitis B e Antigen (HBeAg) negative at baseline
1191224|NCT00324961|O1|Outcome|HBeAg- at Baseline|All participants who were Hepatitis B e Antigen (HBeAg) negative at baseline
1191225|NCT00324961|O1|Outcome|HBeAg- at Baseline|All participants who were Hepatitis B e Antigen (HBeAg) negative at baseline
1191226|NCT00324961|O1|Outcome|HBeAg- at Baseline|All participants who were Hepatitis B e Antigen (HBeAg) negative at baseline
1191227|NCT00324961|O1|Outcome|HBeAg- at Baseline|All participants who were Hepatitis B e Antigen (HBeAg) negative at baseline
1191228|NCT00324961|O1|Outcome|HBeAg- at Baseline|All participants who were Hepatitis B e Antigen (HBeAg) negative at baseline
1191229|NCT00324961|E1|Reported Event|10 mg Adefovir Dipivoxil (ADV)|10 mg ADV tablets once daily for 104 weeks
1191230|NCT00324896|B3|Baseline|Total|Total of all reporting groups
1191231|NCT00324896|B2|Baseline|Placebo|Those randomly assigned to matching placebo, took their dose each night at bedtime
1191232|NCT00324896|B1|Baseline|Eszopiclone|"eszopiclone. Those under 65yo received 3mg of eszoplicone (or randomized to matching placebo)and those 65yo or older received 2mg of eszoplicone (or randomized to matching placebo)taken each night at bedtime~eszopiclone : eszopiclone"
1191407|NCT00324259|O2|Outcome|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
1191233|NCT00324896|P2|Participant Flow|Placebo|Those randomly assigned to matching placebo, took their dose each night at bedtime
1191234|NCT00324896|P1|Participant Flow|Eszopiclone|"eszopiclone. Those under 65yo received 3mg of eszoplicone (or randomized to matching placebo)and those 65yo or older received 2mg of eszoplicone (or randomized to matching placebo)taken each night at bedtime~eszopiclone : eszopiclone"
1191235|NCT00324896|O2|Outcome|Placebo|Those randomly assigned to matching placebo, took their dose each night at bedtime
1191236|NCT00324896|O1|Outcome|Eszopiclone|"eszopiclone. Those under 65yo received 3mg of eszoplicone (or randomized to matching placebo)and those 65yo or older received 2mg of eszoplicone (or randomized to matching placebo)taken each night at bedtime~eszopiclone : eszopiclone"
1191237|NCT00324896|O2|Outcome|Placebo|Those randomly assigned to matching placebo, took their dose each night at bedtime
1191238|NCT00324896|O1|Outcome|Eszopiclone|"eszopiclone. Those under 65yo received 3mg of eszoplicone (or randomized to matching placebo)and those 65yo or older received 2mg of eszoplicone (or randomized to matching placebo)taken each night at bedtime~eszopiclone : eszopiclone"
1191239|NCT00324896|E2|Reported Event|Placebo|Those randomly assigned to matching placebo, took their dose each night at bedtime
1191240|NCT00324896|E1|Reported Event|Eszopiclone|"eszopiclone. Those under 65yo received 3mg of eszoplicone (or randomized to matching placebo)and those 65yo or older received 2mg of eszoplicone (or randomized to matching placebo)taken each night at bedtime~eszopiclone : eszopiclone"
1191312|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
1191313|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
1191241|NCT00324870|B1|Baseline|Arm I|"Phase I: Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.~Phase II: Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I.~vorinostat: Given orally~bevacizumab: Given IV"
1191242|NCT00324870|P1|Participant Flow|Arm I|"Phase I: Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.~Phase II: Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I.~vorinostat: Given orally~bevacizumab: Given IV"
1191243|NCT00324870|O1|Outcome|Arm I|"Phase I: Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.~Phase II: Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I.~vorinostat: Given orally~bevacizumab: Given IV"
1191244|NCT00324870|E1|Reported Event|Arm I|"Phase I: Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.~Phase II: Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I.~vorinostat: Given orally~bevacizumab: Given IV"
1191245|NCT00324857|B5|Baseline|Total|Total of all reporting groups
1191246|NCT00324857|B4|Baseline|Arm 4/ DA and MI|Decision aid and MI
1191247|NCT00324857|B3|Baseline|Arm 3/ Motivational Interview (MI)|Motivational Interviewing
1191248|NCT00324857|B2|Baseline|Arm 2/Decision Aid (DA)|Decision Aid video
1191249|NCT00324857|B1|Baseline|Arm 1/Attention Control|Attention control
1191250|NCT00324857|P4|Participant Flow|Arm 4/ DA and MI|"Decision Aid Video: The research interventionist will show the participant the Dartmouth Knee OA Decision Aid video entitled Treatment Choices for Knee Osteoarthritis. The video gives a detailed explanation of 1) the damage to the knee joint caused by OA; 2) treatment options including lifestyle changes, medications, injections, complementary therapy, and surgery; 3) the risks, benefits, and known efficacy of each treatment option.~Motivational Interviewing: The research intervention will conduct the fact-to-face MI session with the participant. This was used as a mechanism to help patients confront their thoughts about TKR and how to engage their primary care doctors about knee pain"
1191251|NCT00324857|P3|Participant Flow|Arm 3/ Motivational Interview (MI)|Motivational Interviewing: The research intervention will conduct the fact-to-face MI session with the participant. This was used as a mechanism to help patients confront their thoughts about TKR and how to engage their primary care doctors about knee pain
1191252|NCT00324857|P2|Participant Flow|Arm 2/Decision Aid (DA)|"Decision Aid Video: The research interventionist will show the participant the Dartmouth Knee OA Decision Aid video entitled Treatment Choices for Knee Osteoarthritis. The video gives a detailed explanation of 1) the damage to the knee joint caused by OA; 2) treatment options including lifestyle changes, medications, injections, complementary therapy, and surgery; 3) the risks, benefits, and known efficacy of each treatment option."
1191253|NCT00324857|P1|Participant Flow|Arm 1/Attention Control|Subjects randomized to the attention control arm received a patient educational booklet about OA published by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. This booklet provides a brief educational program that summarizes how to live with knee OA but does not specifically mention joint replacement
1191254|NCT00324857|O4|Outcome|Arm 4/ DA and MI|"Decision Aid Video: The research interventionist will show the participant the Dartmouth Knee OA Decision Aid video entitled Treatment Choices for Knee Osteoarthritis. The video gives a detailed explanation of 1) the damage to the knee joint caused by OA; 2) treatment options including lifestyle changes, medications, injections, complementary therapy, and surgery; 3) the risks, benefits, and known efficacy of each treatment option.~Motivational Interviewing: The research intervention will conduct the fact-to-face MI session with the participant. This was used as a mechanism to help patients confront their thoughts about TKR and how to engage their primary care doctors about knee pain"
1191408|NCT00324259|O1|Outcome|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
1191255|NCT00324857|O3|Outcome|Arm 3/ Motivational Interview (MI)|Motivational Interviewing: The research intervention will conduct the fact-to-face MI session with the participant. This was used as a mechanism to help patients confront their thoughts about TKR and how to engage their primary care doctors about knee pain
1191256|NCT00324857|O2|Outcome|Arm 2/Decision Aid (DA)|"Decision Aid Video: The research interventionist will show the participant the Dartmouth Knee OA Decision Aid video entitled Treatment Choices for Knee Osteoarthritis. The video gives a detailed explanation of 1) the damage to the knee joint caused by OA; 2) treatment options including lifestyle changes, medications, injections, complementary therapy, and surgery; 3) the risks, benefits, and known efficacy of each treatment option."
1191257|NCT00324857|O1|Outcome|Arm 1/Attention Control|Subjects randomized to the attention control arm received a patient educational booklet about OA published by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. This booklet provides a brief educational program that summarizes how to live with knee OA but does not specifically mention joint replacement
1191258|NCT00324857|E4|Reported Event|Arm 4/ DA and MI|Decision Aid and MI
1191259|NCT00324857|E3|Reported Event|Arm 3/ Motivational Interview (MI)|Motivational Interviewing
1191260|NCT00324857|E2|Reported Event|Arm 2/Decision Aid (DA)|Decision Aid
1191261|NCT00324857|E1|Reported Event|Arm 1/Attention Control|Attention Control
1191314|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
1191262|NCT00324740|B1|Baseline|Treatment (Vorinostat and Isotretinoin)|"Patients receive oral vorinostat (SAHA) twice daily and oral isotretinoin twice daily on days 3-5, 10-12, 17-19, and 24-26. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
1191263|NCT00324740|P3|Participant Flow|Dose Level 3: Vorinostat (300mg) and Isotretinoin (0.5 mg/kg)|"Patients receive oral vorinostat (SAHA-300 mg) twice daily and oral isotretinoin (0.5 mg/kg) twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
1191264|NCT00324740|P2|Participant Flow|Dose Level 2 Vorinostat (300mg) and Isotretinoin (0.375 mg/kg)|"Patients receive oral vorinostat (SAHA-300 mg) twice daily and oral isotretinoin (0.375 mg/kg) twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
1191265|NCT00324740|P1|Participant Flow|Dose Level 1: Vorinostat (300mg) and Isotretinoin (0.25 mg/kg)|"Patients receive oral vorinostat (SAHA-300 mg) twice daily and oral isotretinoin (0.25 mg/kg) twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
1191266|NCT00324740|O1|Outcome|Treatment (Vorinostat and Isotretinoin)|"Patients receive oral vorinostat (SAHA) twice daily and oral isotretinoin twice daily on days 3-5, 10-12, 17-19, and 24-26. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
1191267|NCT00324740|O3|Outcome|Dose Level 2 Vorinostat (300mg)and Isotretinoin (0.5 mg/kg)|"Patients receive oral vorinostat (SAHA) and oral isotretinoin twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
1191268|NCT00324740|O2|Outcome|Dose Level 2 Vorinostat (300mg)and Isotretinoin (0.375 mg/kg)|"Patients receive oral vorinostat (SAHA) and oral isotretinoin twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
1191269|NCT00324740|O1|Outcome|Dose Level 1: Vorinostat (300mg) and Isotretinoin (0.25 mg/kg)|"Patients receive oral vorinostat (SAHA) and oral isotretinoin twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
1191270|NCT00324740|E1|Reported Event|Treatment (Vorinostat and Isotretinoin)|"Patients receive oral vorinostat (SAHA) twice daily and oral isotretinoin twice daily on days 3-5, 10-12, 17-19, and 24-26. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
1191271|NCT00324701|B3|Baseline|Total|Total of all reporting groups
1191272|NCT00324701|B2|Baseline|Face-to-face Therapy|therapy delivered at the VAMC in the same room as the therapist
1191273|NCT00324701|B1|Baseline|Telepsychology|therapy done at patients house using in-home video conferencing technology
1191274|NCT00324701|P2|Participant Flow|Face-to-face Therapy|therapy delivered at the VAMC in the same room as the therapist
1191275|NCT00324701|P1|Participant Flow|Telepsychology|therapy done at patients house using in-home video conferencing technology
1191276|NCT00324701|O2|Outcome|Face-to-face Therapy|therapy delivered at the VAMC in the same room as the therapist
1191277|NCT00324701|O1|Outcome|Telepsychology|therapy done at patients house using in-home video conferencing technology
1191278|NCT00324701|O2|Outcome|Face-to-face Therapy|therapy delivered at the VAMC in the same room as the therapist
1191279|NCT00324701|O1|Outcome|Telepsychology|therapy done at patients house using in-home video conferencing technology
1191280|NCT00324701|E2|Reported Event|Face-to-face Therapy|therapy delivered at the VAMC in the same room as the therapist
1191281|NCT00324701|E1|Reported Event|Telepsychology|therapy done at patients house using in-home video conferencing technology
1191282|NCT00324675|B3|Baseline|Total|Total of all reporting groups
1191283|NCT00324675|B2|Baseline|Placebo|
1191284|NCT00324675|B1|Baseline|Rosiglitazone|
1191285|NCT00324675|P2|Participant Flow|Placebo|
1191286|NCT00324675|P1|Participant Flow|Rosiglitazone|
1191287|NCT00324675|O2|Outcome|Placebo|
1191288|NCT00324675|O1|Outcome|Rosiglitazone|
1191289|NCT00324675|E2|Reported Event|Placebo|
1191290|NCT00324675|E1|Reported Event|Rosiglitazone|
1191291|NCT00324649|B3|Baseline|Total|Total of all reporting groups
1191292|NCT00324649|B2|Baseline|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
1191293|NCT00324649|B1|Baseline|Truvada|Truvada + NNRTI or PI.
1191294|NCT00324649|P2|Participant Flow|Zidovudine/Lamivudine|Zidovudine/lamivudine + nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI).
1191295|NCT00324649|P1|Participant Flow|Truvada|Truvada + nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI).
1191296|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
1191297|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
1191298|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
1191299|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
1191300|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
1191301|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
1191302|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
1191303|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
1191304|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
1191305|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
1191306|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
1191307|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
1191308|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
1191309|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
1191310|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
1191322|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
1191323|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
1191324|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
1191325|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
1191326|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
1191327|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
1191328|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
1191329|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
1191330|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
1191331|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
1191332|NCT00324649|E2|Reported Event|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
1191333|NCT00324649|E1|Reported Event|Truvada|Truvada + NNRTI or PI.
1191334|NCT00324415|B1|Baseline|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
1191335|NCT00324415|P1|Participant Flow|Combined Modality Therapy|Combined modality therapy consists of cisplatin, 5-flourouracil, and irradiation plus cetuximab
1191336|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab
1191337|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab
1191338|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab
1191339|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab
1191340|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab
1191341|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
1191342|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
1191343|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
1191344|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
1191345|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
1191346|NCT00324415|E1|Reported Event|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab
1191347|NCT00324350|B3|Baseline|Total|Total of all reporting groups
1191348|NCT00324350|B2|Baseline|Standard Glycemic Control|standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
1191349|NCT00324350|B1|Baseline|Intensive Glycemic Control|intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
1191350|NCT00324350|P2|Participant Flow|Standard Glycemic Control|standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
1191351|NCT00324350|P1|Participant Flow|Intensive Glycemic Control|intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
1191352|NCT00324350|O2|Outcome|Standard Glycemic Control|standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
1191353|NCT00324350|O1|Outcome|Intensive Glycemic Control|intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
1191409|NCT00324259|O2|Outcome|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
1191354|NCT00324350|O2|Outcome|Standard Glycemic Control|standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
1191355|NCT00324350|O1|Outcome|Intensive Glycemic Control|intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%) in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
1191356|NCT00324350|O2|Outcome|Standard Glycemic Control|standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
1191357|NCT00324350|O1|Outcome|Intensive Glycemic Control|intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
1191358|NCT00324350|E2|Reported Event|Standard Glycemic Control|standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
1191359|NCT00324350|E1|Reported Event|Intensive Glycemic Control|intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
1191360|NCT00324272|B5|Baseline|Total|Total of all reporting groups
1191361|NCT00324272|B4|Baseline|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191433|NCT00324168|B2|Baseline|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
1199145|NCT00301262|O2|Outcome|DB Placebo / OL Viagra|
1191362|NCT00324272|B3|Baseline|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191363|NCT00324272|B2|Baseline|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191364|NCT00324272|B1|Baseline|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191365|NCT00324272|P4|Participant Flow|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191366|NCT00324272|P3|Participant Flow|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191367|NCT00324272|P2|Participant Flow|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191368|NCT00324272|P1|Participant Flow|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191410|NCT00324259|O1|Outcome|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
1191411|NCT00324259|O2|Outcome|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
1191412|NCT00324259|O1|Outcome|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
1191369|NCT00324272|O4|Outcome|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191370|NCT00324272|O3|Outcome|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191371|NCT00324272|O2|Outcome|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191434|NCT00324168|B1|Baseline|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
1191753|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
1191754|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
1191372|NCT00324272|O1|Outcome|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191373|NCT00324272|O4|Outcome|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191374|NCT00324272|O3|Outcome|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191375|NCT00324272|O2|Outcome|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191376|NCT00324272|O1|Outcome|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191377|NCT00324272|O4|Outcome|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191378|NCT00324272|O3|Outcome|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191379|NCT00324272|O2|Outcome|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191413|NCT00324259|O2|Outcome|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
1191414|NCT00324259|O1|Outcome|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
1195584|NCT00313144|O1|Outcome|Baseline|
1191380|NCT00324272|O1|Outcome|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191381|NCT00324272|O4|Outcome|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191435|NCT00324168|P2|Participant Flow|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, then twice a day for 1 week, and finally once a day for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
1191755|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
1191756|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
1191382|NCT00324272|O3|Outcome|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191383|NCT00324272|O2|Outcome|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191384|NCT00324272|O1|Outcome|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191385|NCT00324272|O4|Outcome|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191386|NCT00324272|O3|Outcome|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191387|NCT00324272|O2|Outcome|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191388|NCT00324272|O1|Outcome|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191389|NCT00324272|O4|Outcome|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191390|NCT00324272|O3|Outcome|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191391|NCT00324272|O2|Outcome|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191392|NCT00324272|O1|Outcome|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191393|NCT00324272|O4|Outcome|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191394|NCT00324272|O3|Outcome|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191395|NCT00324272|O2|Outcome|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191396|NCT00324272|O1|Outcome|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191397|NCT00324272|E4|Reported Event|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191398|NCT00324272|E3|Reported Event|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191399|NCT00324272|E2|Reported Event|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191400|NCT00324272|E1|Reported Event|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
1191401|NCT00324259|B3|Baseline|Total|Total of all reporting groups
1191402|NCT00324259|B2|Baseline|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
1191403|NCT00324259|B1|Baseline|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
1191404|NCT00324259|P2|Participant Flow|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
1191405|NCT00324259|P1|Participant Flow|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
1191406|NCT00324259|O1|Outcome|Arm 1 (6 mg Estradiol) and Arm 2 (30 mg Estradiol)|"Arm 1 = 6 mg of estradiol daily (2 mg tid).~Arm 2 = 30 mg of estradiol. (10 mg tid)"
1195585|NCT00313144|O4|Outcome|>12 Months to ≤18 Months|
1191422|NCT00324259|E1|Reported Event|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
1191423|NCT00324233|B3|Baseline|Total|Total of all reporting groups
1191424|NCT00324233|B2|Baseline|SCCM Then SC|SpeediCath Compact Male (SCCM)catheter in the first period then SpeediCath(SC)catheter in second period
1191425|NCT00324233|B1|Baseline|SC Then SCCM|SpeediCath (SC)catheter in first period then SpeediCath Compact Male (SCCM)catheter in second period
1191426|NCT00324233|P2|Participant Flow|SCCM Then SC|SpeediCath Compact Male (SCCM)catheter in the first period then SpeediCath(SC)catheter in second period
1191427|NCT00324233|P1|Participant Flow|SC Then SCCM|SpeediCath (SC)catheter in first period then SpeediCath Compact Male (SCCM)catheter in second period
1191428|NCT00324233|O2|Outcome|SpediCath Compact Male|
1191429|NCT00324233|O1|Outcome|SpeediCath|
1191430|NCT00324233|E2|Reported Event|SCCM Then SC|SpeediCath Compact Male (SCCM)catheter in the first period then SpeediCath(SC)catheter in second period
1191431|NCT00324233|E1|Reported Event|SC Then SCCM|SpeediCath (SC)catheter in first period then SpeediCath Compact Male (SCCM)catheter in second period
1191436|NCT00324168|P1|Participant Flow|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, then twice a day for 1 week, and finally once a day for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
1191437|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
1191438|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
1191439|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
1191440|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
1191441|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
1191442|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
1191443|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
1191444|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
1191445|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
1191446|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
1191447|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
1191448|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
1191449|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
1191450|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
1191451|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
1191452|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
1191507|NCT00324038|P2|Participant Flow|Co-codamol Tablets|combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
1191453|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
1191454|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
1191455|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
1191456|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
1191457|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
1191458|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
1191459|NCT00324168|E2|Reported Event|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
1191757|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
1191758|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
1191759|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
1191460|NCT00324168|E1|Reported Event|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
1191461|NCT00324155|B3|Baseline|Total|Total of all reporting groups
1191462|NCT00324155|B2|Baseline|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
1191463|NCT00324155|B1|Baseline|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
1191464|NCT00324155|P2|Participant Flow|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until disease progression (PD), unacceptable toxicity, or withdrawal of consent~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
1191465|NCT00324155|P1|Participant Flow|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks was continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
1191466|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
1191467|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
1191468|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
1191469|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks was continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
1191470|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; one dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
1191743|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
1191471|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10m g/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
1191472|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks then1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
1191473|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
1191474|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent"
1191760|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
1191475|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
1191476|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
1191477|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In maintenance phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
1191478|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; one dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
1191479|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression, (PD) unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
1191480|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
1191481|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
1191482|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
1191483|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1e dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
1191484|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
1191508|NCT00324038|P1|Participant Flow|Buprenorphine Transdermal System|Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days
1191509|NCT00324038|O2|Outcome|Co-codamol Tablets|combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
1191510|NCT00324038|O1|Outcome|Buprenorphine Transdermal System|Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days
1191485|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks was continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
1191486|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until disease progression (PD), unacceptable toxicity, or withdrawal of consent~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent"
1191487|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10mg/kg, every 12 weeks will be continued until disease progression. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
1191761|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
1191762|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
1191488|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
1191489|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks was continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
1191490|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent"
1191491|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
1191492|NCT00324155|E2|Reported Event|Placebo + Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks then 1 dose every 12 weeks starting at Week 24; until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
1191493|NCT00324155|E1|Reported Event|10 mg/kg Ipilimumab + Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10mg/kg, every 12 wks was continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
1191494|NCT00324116|B1|Baseline|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
1191495|NCT00324116|P1|Participant Flow|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
1191496|NCT00324116|O1|Outcome|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
1191497|NCT00324116|O1|Outcome|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
1191498|NCT00324116|O1|Outcome|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
1191499|NCT00324116|O1|Outcome|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
1191500|NCT00324116|O1|Outcome|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
1191501|NCT00324116|O1|Outcome|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
1191502|NCT00324116|O1|Outcome|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
1191503|NCT00324116|E1|Reported Event|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
1191504|NCT00324038|B3|Baseline|Total|Total of all reporting groups
1191505|NCT00324038|B2|Baseline|Co-codamol Tablets|combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
1191506|NCT00324038|B1|Baseline|Buprenorphine Transdermal System|Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days
1191744|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
1191511|NCT00324038|E2|Reported Event|Co-codamol Tablets|combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
1191512|NCT00324038|E1|Reported Event|Buprenorphine Transdermal System|Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days
1191513|NCT00323882|B6|Baseline|Total|Total of all reporting groups
1191514|NCT00323882|B5|Baseline|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191763|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
1191764|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
1191834|NCT00323284|O1|Outcome|A--iStent Plus Cataract Surgery|iStent plus Cataract Surgery
1191835|NCT00323284|O2|Outcome|B--Cataract Surgery Only|Cataract Surgery only
1191515|NCT00323882|B4|Baseline|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191516|NCT00323882|B3|Baseline|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191517|NCT00323882|B2|Baseline|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191518|NCT00323882|B1|Baseline|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes intravenously (IV) on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of stable disease (SD) or conflicting disease response assessment (CDRA) at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191519|NCT00323882|P5|Participant Flow|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191520|NCT00323882|P4|Participant Flow|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to Response Evaluation Criteria in Solid Tumors (RECIST), target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191521|NCT00323882|P3|Participant Flow|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191522|NCT00323882|P2|Participant Flow|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses (maintenance). The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191523|NCT00323882|P1|Participant Flow|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes intravenously (IV) on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of stable disease (SD) or conflicting disease response assessment (CDRA) at the end of the induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191524|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191808|NCT00323310|E1|Reported Event|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
1191809|NCT00323297|B3|Baseline|Total|Total of all reporting groups
1191836|NCT00323284|O1|Outcome|A--iStent Plus Cataract Surgery|iStent plus Cataract Surgery
1191837|NCT00323284|E2|Reported Event|B--Cataract Surgery Only|Cataract Surgery only
1191525|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191526|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191527|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191528|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191529|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191530|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191531|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191532|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191533|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191596|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
1191597|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
1191745|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
1191534|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191535|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191536|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191537|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191538|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191539|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191540|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191541|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191542|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191543|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191544|NCT00323882|O6|Outcome|All Treated Participants|All treatment groups are combined to show total overall survival at completion of Follow Up.
1191598|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
1191599|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
1191545|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191546|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191547|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191548|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191549|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191550|NCT00323882|O6|Outcome|All Treated Participants|All participants in all treatment arms combined.
1191551|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191552|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191553|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191554|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191555|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191600|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
1191601|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
1191556|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191557|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191558|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191559|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191560|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191561|NCT00323882|O3|Outcome|Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive)|In those participants with no prior chemotherapy, a single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191562|NCT00323882|O2|Outcome|Ipilimumab 10 mg/kg + XRT Combination (Prior Chemotherapy)|In those who received chemotherapy prior to enrolling in this study, a single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191563|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191564|NCT00323882|O3|Outcome|Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive)|In those participants who had received no chemotherapy prior to the study, a single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191602|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
1191603|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
1191574|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191565|NCT00323882|O2|Outcome|Ipilimumab 10 mg/kg + XRT Combination (Prior Chemotherapy)|In those who received chemotherapy prior to enrolling in this study, a single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191566|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191567|NCT00323882|O6|Outcome|Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive)|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191568|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination (Prior Chemotherapy)|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191569|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191570|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191571|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191572|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191573|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191604|NCT00323869|E1|Reported Event|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
1191736|NCT00323492|P3|Participant Flow|Delayed Truvada|Truvada + NNRTI or PI (participants from the control group who switched NRTIs to Truvada during Study Phase 2).
1191737|NCT00323492|P2|Participant Flow|Maintain Baseline Regimen|Maintain baseline regimen.
1191746|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
1191575|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191576|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191577|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191578|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191579|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191580|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191581|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191582|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191583|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191605|NCT00323739|B1|Baseline|Bevacizumab and Everolimus|Patients received 10mg/kg of bevacizumab by IV infusion on day 1 and day 15 of each 28-day treatment cycle. Patients took 1 10mg tablet of everolimus every day for 28 days. Treatment continued until evidence of their disease worsening was found or until the side effects of treatment became intolerable to the patient. The treating physician could also stop treatment if the patient's safety was felt to be at risk.
1191738|NCT00323492|P1|Participant Flow|Truvada|Truvada + nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI).
1191584|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191585|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191586|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191587|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191588|NCT00323882|E5|Reported Event|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191589|NCT00323882|E4|Reported Event|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191590|NCT00323882|E3|Reported Event|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191591|NCT00323882|E2|Reported Event|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191592|NCT00323882|E1|Reported Event|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
1191593|NCT00323869|B1|Baseline|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
1191594|NCT00323869|P1|Participant Flow|Bevacizumab + Carboplatin + Gemcitabine|"Bevacizumab in combination with carboplatin and gemcitabine~Bevacizumab was administered 15 mg/kg IV on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles in combination with chemotherapy, then continuing until evidence of progressive disease or significant treatment-related toxicity Gemcitabine, administered 1000 mg/m2 IV on days 1 and 8 of each 3-week cycle (twice per cycle) for up to 6 cycles Carboplatin, administered IV at area under the curve (AUC) of 5, every 3 weeks on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles~Carboplatin was administered before gemcitabine infusion.~Bevacizumab was administered 1 hour after end of all chemotherapy infusions.~Bevacizumab: Murine humanized anti-vascular endothelial growth factor A (VEGF-A) monoclonal antibody~Gemcitabine: Nucleoside analog~Carboplatin: Alkylating agent"
1191595|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
1191739|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
1191740|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
1191606|NCT00323739|P1|Participant Flow|Bevacizumab and Everolimus|Patients received 10mg/kg of bevacizumab by IV infusion on day 1 and day 15 of each 28-day treatment cycle. Patients took 1 10mg tablet of everolimus every day for 28 days. Treatment continued until evidence of their disease worsening was found or until the side effects of treatment became intolerable to the patient. The treating physician could also stop treatment if the patient's safety was felt to be at risk.
1191607|NCT00323739|O1|Outcome|Bevacizumab and Everolimus|Patients received 10mg/kg of bevacizumab by IV infusion on day 1 and day 15 of each 28-day treatment cycle. Patients took 1 10mg tablet of everolimus every day for 28 days. Treatment continued until evidence of their disease worsening was found or until the side effects of treatment became intolerable to the patient. The treating physician could also stop treatment if the patient's safety was felt to be at risk.
1191608|NCT00323739|O1|Outcome|Bevacizumab and Everolimus|Patients received 10mg/kg of bevacizumab by IV infusion on day 1 and day 15 of each 28-day treatment cycle. Patients took 1 10mg tablet of everolimus every day for 28 days. Treatment continued until evidence of their disease worsening was found or until the side effects of treatment became intolerable to the patient. The treating physician could also stop treatment if the patient's safety was felt to be at risk.
1191609|NCT00323739|E1|Reported Event|Bevacizumab + Everolimus|
1191610|NCT00323635|B3|Baseline|Total|Total of all reporting groups
1191611|NCT00323635|B2|Baseline|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
1191612|NCT00323635|B1|Baseline|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
1191613|NCT00323635|P2|Participant Flow|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
1191614|NCT00323635|P1|Participant Flow|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
1191615|NCT00323635|O2|Outcome|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
1191616|NCT00323635|O1|Outcome|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
1191617|NCT00323635|O2|Outcome|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
1191618|NCT00323635|O1|Outcome|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
1191619|NCT00323635|O2|Outcome|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
1191620|NCT00323635|O1|Outcome|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
1191621|NCT00323635|O2|Outcome|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
1191622|NCT00323635|O1|Outcome|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
1191623|NCT00323635|O2|Outcome|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
1191624|NCT00323635|O1|Outcome|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
1191625|NCT00323635|O2|Outcome|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
1191626|NCT00323635|O1|Outcome|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
1191627|NCT00323635|E2|Reported Event|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
1191628|NCT00323635|E1|Reported Event|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
1191629|NCT00323622|B9|Baseline|Total|Total of all reporting groups
1191630|NCT00323622|B8|Baseline|Cohort 2-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
1191631|NCT00323622|B7|Baseline|Cohort 2-Prevnar- Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
1191632|NCT00323622|B6|Baseline|Cohort 1-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
1191633|NCT00323622|B5|Baseline|Cohort 1-Prevnar-Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
1191634|NCT00323622|B4|Baseline|Cohort 2-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
1191647|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
1191635|NCT00323622|B3|Baseline|Cohort 2-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
1191831|NCT00323284|P2|Participant Flow|B--Cataract Surgery Only|Cataract Surgery only
1191832|NCT00323284|P1|Participant Flow|A--iStent Plus Cataract Surgery|iStent plus Cataract Surgery
1199146|NCT00301262|O1|Outcome|DB Viagra / OL Viagra|
1191636|NCT00323622|B2|Baseline|Cohort 1-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
1191637|NCT00323622|B1|Baseline|Cohort 1-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
1191638|NCT00323622|P8|Participant Flow|Cohort 2-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study
1191639|NCT00323622|P7|Participant Flow|Cohort 2-Prevnar- Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
1191640|NCT00323622|P6|Participant Flow|Cohort 1-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
1191641|NCT00323622|P5|Participant Flow|Cohort 1-Prevnar-Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
1191642|NCT00323622|P4|Participant Flow|Cohort 2-RTS,S/AS02A≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
1191643|NCT00323622|P3|Participant Flow|Cohort 2-RTS,S/AS02A<24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
1191644|NCT00323622|P2|Participant Flow|Cohort 1-RTS,S/AS02A≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
1191645|NCT00323622|P1|Participant Flow|Cohort 1-RTS,S/AS02A<24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection
1191646|NCT00323622|O2|Outcome|Cohort 1-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
1191727|NCT00323557|P1|Participant Flow|Pneumococcal Vaccine + GM-CSF|Vaccine subcutaneously + GM-CSF (3 Doses of 250 mg subcutaneously) given either Pre Vaccine at Day -7, Day -1 and Day 0 (day of pneumococcal vaccine) or Post Vaccine given at Day 0, Day +3 and Day +7.
1191728|NCT00323557|O3|Outcome|Pneumococcal Vaccine Alone|First vaccine dose subcutaneously, Day 0. No CM-CSF.
1191741|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
1191659|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
1191833|NCT00323284|O2|Outcome|B--Cataract Surgery Only|Cataract Surgery only
1191648|NCT00323622|O2|Outcome|Cohort 1-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
1191649|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
1191650|NCT00323622|O2|Outcome|Cohort 1-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
1191651|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
1191652|NCT00323622|O2|Outcome|Cohort 1-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
1191653|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
1191654|NCT00323622|O2|Outcome|Cohort 1-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
1191655|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
1191656|NCT00323622|O2|Outcome|Cohort 1-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
1191657|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
1191658|NCT00323622|O2|Outcome|Cohort 1-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
1191729|NCT00323557|O2|Outcome|Pneumococcal Vaccine + Post Vaccine GM-CSF|Vaccine subcutaneously + GM-CSF 3 Doses of 250 mg subcutaneously given Day 0 (day of pneumococcal vaccine), and post vaccination at Day +3 and Day +7.
1191660|NCT00323622|O4|Outcome|Cohort 2-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
1191661|NCT00323622|O3|Outcome|Cohort 2-Prevnar- Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
1191662|NCT00323622|O2|Outcome|Cohort 2-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
1191663|NCT00323622|O1|Outcome|Cohort 2-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
1191664|NCT00323622|O4|Outcome|Cohort 2-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. This group is part of the Cohort 2 of the study, which was followed for analysis of malaria disease, and pools subjects from the Cohort 2-Engerix-B ≥24M and Cohort 2-Prevnar-Hiberix <24M groups. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
1191665|NCT00323622|O3|Outcome|Cohort 2-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. This group is part of the Cohort 2 of the study, which was followed for analysis of malaria disease, and pools subjects from the Cohort 2-RTS,S/AS02A <24M and Cohort 2-RTS,S/AS02A ≥24M groups. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
1191666|NCT00323622|O2|Outcome|Cohort 1-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
1191667|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
1191668|NCT00323622|O8|Outcome|Cohort 2-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
1191730|NCT00323557|O1|Outcome|Pneumococcal Vaccine + Pre Vaccine GM-CSF|Vaccine subcutaneously + GM-CSF 3 Doses of 250 mg subcutaneously given pre vaccination Day -7, Day -1 and Day 0 (day of pneumococcal vaccine).
1191731|NCT00323557|E2|Reported Event|Pneumococcal Vaccine Alone|First vaccine dose subcutaneously, Day 0.
1191742|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
1191747|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
1191748|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
1191749|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
1191750|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
1191751|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
1191752|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
1191669|NCT00323622|O7|Outcome|Cohort 2-Prevnar- Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
1191670|NCT00323622|O6|Outcome|Cohort 1-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
1191671|NCT00323622|O5|Outcome|Cohort 1-Prevnar-Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
1191672|NCT00323622|O4|Outcome|Cohort 2-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
1191673|NCT00323622|O3|Outcome|Cohort 2-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
1191674|NCT00323622|O2|Outcome|Cohort 1-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
1191675|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
1191676|NCT00323622|E8|Reported Event|Cohort 2-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
1191677|NCT00323622|E7|Reported Event|Cohort 2-Prevnar- Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
1191678|NCT00323622|E6|Reported Event|Cohort 1-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
1191679|NCT00323622|E5|Reported Event|Cohort 1-Prevnar-Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
1191680|NCT00323622|E4|Reported Event|Cohort 2-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
1191732|NCT00323557|E1|Reported Event|Pneumococcal Vaccine + GM-CSF|Vaccine subcutaneously + GM-CSF (3 Doses of 250 mg subcutaneously) given either Pre Vaccine at Day -7, Day -1 and Day 0 (day of pneumococcal vaccine) or Post Vaccine given at Day 0, Day +3 and Day +7.
1191733|NCT00323492|B3|Baseline|Total|Total of all reporting groups
1191734|NCT00323492|B2|Baseline|Maintain Baseline Regimen|Maintain baseline regimen.
1191681|NCT00323622|E3|Reported Event|Cohort 2-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
1191682|NCT00323622|E2|Reported Event|Cohort 1-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
1191683|NCT00323622|E1|Reported Event|Cohort 1-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
1191684|NCT00323609|B3|Baseline|Total|Total of all reporting groups
1191685|NCT00323609|B2|Baseline|Vertebroplasty|This group of patients has received vertebroplasty procedure.
1191686|NCT00323609|B1|Baseline|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
1191687|NCT00323609|P4|Participant Flow|Vertebroplasty Not Treated Patients|Patients who met the enrollment criteria at screening and were randomized to treatment group had terminated prior to surgery or those who no longer met the inclusion criteria prior to surgery.
1191688|NCT00323609|P3|Participant Flow|Kyphoplasty Not Treated Patients|Patients who met the enrollment criteria at screening and were randomized to treatment group had terminated prior to surgery or those who no longer met the inclusion criteria prior to surgery.
1191689|NCT00323609|P2|Participant Flow|Vertebroplasty|This group of patients has received vertebroplasty procedure.
1191690|NCT00323609|P1|Participant Flow|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
1191691|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
1191692|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
1191693|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
1191694|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
1191695|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
1191696|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
1191697|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
1191698|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
1191699|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
1191700|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
1191701|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
1191702|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
1191703|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
1191704|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
1191705|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
1191706|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
1191707|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
1191708|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
1191709|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
1191710|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
1191711|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
1191712|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
1191713|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
1191714|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
1191715|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
1191716|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
1191717|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
1191718|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
1191719|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
1191720|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
1191721|NCT00323609|E2|Reported Event|Vertebroplasty|This group of patients has received vertebroplasty procedure.
1191722|NCT00323609|E1|Reported Event|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
1191723|NCT00323557|B3|Baseline|Total|Total of all reporting groups
1191724|NCT00323557|B2|Baseline|Pneumococcal Vaccine Alone|First vaccine dose subcutaneously, Day 0.
1191725|NCT00323557|B1|Baseline|Pneumococcal Vaccine + GM-CSF|Vaccine subcutaneously + GM-CSF (3 Doses of 250 mg subcutaneously) given either Pre Vaccine at Day -7, Day -1 and Day 0 (day of pneumococcal vaccine) or Post Vaccine given at Day 0, Day +3 and Day +7.
1191726|NCT00323557|P2|Participant Flow|Pneumococcal Vaccine Alone|First vaccine dose subcutaneously, Day 0.
1191735|NCT00323492|B1|Baseline|Truvada|Truvada + NNRTI or PI.
1191765|NCT00323492|E3|Reported Event|All Truvada|"Truvada + NNRTI or PI (all participants who received Truvada during the study, i.e., participants in the Truvada and Delayed Truvada groups). The number of participants at risk is the number who started the study by switching to Truvada (Truvada group), plus those who started the study by maintaining their baseline regimen but who switched to Truvada during the study (Delayed Truvada group). The number of participants at risk increases over time (from 47 at baseline to 72 when the last switch to Truvada took place; 25 participants switched to Truvada from the maintain baseline regimen group in Study Phase 2)."
1191766|NCT00323492|E2|Reported Event|Maintain Baseline Regimen|Maintain baseline regimen. The number of participants at risk is the number who started the study by maintaining their baseline regimen. Per protocol, participants in this group were allowed to switch to Truvada after Week 12 (Delayed TVD group), therefore the number of participants at risk declines over time (from 45 at baseline to 17 who completed Study Phase 2; with most participants switching to Truvada at Week 12).
1191767|NCT00323492|E1|Reported Event|Truvada|Truvada + NNRTI or PI. The number of participants at risk is the number who started the study by switching to Truvada. Participants in this group were to remain on Truvada for 48 weeks (duration of the study). The number at risk was reduced only by study discontinuation (from 47 at baseline to 40 who completed Study Phase 2).
1191768|NCT00323479|B1|Baseline|Anastrozole 1 mg|Anastrozole 1 mg once daily
1191769|NCT00323479|P1|Participant Flow|Anastrozole 1 mg|Anastrozole 1 mg once daily
1191770|NCT00323479|O1|Outcome|Anastrozole 1 mg|Anastrozole 1 mg once daily
1191771|NCT00323479|O1|Outcome|Anastrozole 1 mg|Anastrozole 1 mg once daily
1191772|NCT00323479|O1|Outcome|Anastrozole 1 mg|Anastrozole 1 mg once daily
1191773|NCT00323479|O1|Outcome|Anastrozole 1 mg|Anastrozole 1 mg once daily
1191774|NCT00323479|O1|Outcome|Anastrozole 1 mg|Anastrozole 1 mg once daily
1191775|NCT00323479|O1|Outcome|Anastrozole 1 mg|Anastrozole 1 mg once daily
1191776|NCT00323479|E1|Reported Event|Anastrozole 1 mg|Anastrozole 1 mg once daily
1191777|NCT00323427|B3|Baseline|Total|Total of all reporting groups
1191778|NCT00323427|B2|Baseline|Arm 2|Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
1191779|NCT00323427|B1|Baseline|Arm 1|Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator
1191780|NCT00323427|P2|Participant Flow|Hearing Aids|Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
1191781|NCT00323427|P1|Participant Flow|Group Aural Rehabilitation|Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator
1191782|NCT00323427|O2|Outcome|Arm 2|Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
1191783|NCT00323427|O1|Outcome|Arm 1|Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator
1191784|NCT00323427|O2|Outcome|Arm 2|Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
1191785|NCT00323427|O1|Outcome|Arm 1|Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator
1191786|NCT00323427|O2|Outcome|Arm 2|Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
1191787|NCT00323427|O1|Outcome|Arm 1|Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator
1191788|NCT00323427|E2|Reported Event|Arm 2|Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
1191789|NCT00323427|E1|Reported Event|Arm 1|Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator
1191790|NCT00323362|B1|Baseline|Gemcitabine Hydrochloride and Imatinib Mesylate|"gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.~imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days"
1191791|NCT00323362|P1|Participant Flow|Gemcitabine Hydrochloride and Imatinib Mesylate|"gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.~imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days"
1191792|NCT00323362|O1|Outcome|Gemcitabine Hydrochloride and Imatinib Mesylate|"gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.~imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days"
1191793|NCT00323362|O1|Outcome|Gemcitabine Hydrochloride and Imatinib Mesylate|"gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.~imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days"
1191794|NCT00323362|O1|Outcome|Gemcitabine Hydrochloride and Imatinib Mesylate|"gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.~imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days"
1191795|NCT00323362|E1|Reported Event|Gemcitabine Hydrochloride and Imatinib Mesylate|"gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.~imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days"
1191796|NCT00323310|B1|Baseline|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
1191797|NCT00323310|P1|Participant Flow|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
1191798|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
1191799|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
1191800|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
1191801|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
1191802|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
1191803|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
1191804|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
1191805|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
1191806|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
1191807|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
1191810|NCT00323297|B2|Baseline|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
1191811|NCT00323297|B1|Baseline|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months"
1191812|NCT00323297|P2|Participant Flow|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
1191813|NCT00323297|P1|Participant Flow|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
1191814|NCT00323297|O2|Outcome|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
1191815|NCT00323297|O1|Outcome|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months"
1191816|NCT00323297|O2|Outcome|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
1191817|NCT00323297|O1|Outcome|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months"
1191818|NCT00323297|O2|Outcome|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
1191819|NCT00323297|O1|Outcome|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months"
1191820|NCT00323297|O2|Outcome|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
1191821|NCT00323297|O1|Outcome|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months"
1191822|NCT00323297|O2|Outcome|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
1191823|NCT00323297|O1|Outcome|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months"
1191999|NCT00322556|O1|Outcome|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
1191824|NCT00323297|O2|Outcome|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
1191825|NCT00323297|O1|Outcome|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months"
1191826|NCT00323297|E2|Reported Event|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
1191827|NCT00323297|E1|Reported Event|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
1191828|NCT00323284|B3|Baseline|Total|Total of all reporting groups
1191829|NCT00323284|B2|Baseline|B--Cataract Surgery Only|Cataract Surgery only
1191830|NCT00323284|B1|Baseline|A--iStent Plus Cataract Surgery|iStent plus Cataract Surgery
1191838|NCT00323284|E1|Reported Event|A--iStent Plus Cataract Surgery|iStent plus Cataract Surgery
1191839|NCT00323271|B3|Baseline|Total|Total of all reporting groups
1191840|NCT00323271|B2|Baseline|Educational Intervention|"Interventional: Educational intervention~Interventional: Educational intervention: Session topics will include information on the etiology of MS, MS subtypes and disease progression, common symptoms of MS, medical management of MS, rehabilitation approaches to management of MS-related symptoms, exercise, sick day management, stress management, psychosocial adjustment, family involvement, and appropriate use of the health care system."
1191841|NCT00323271|B1|Baseline|Cognitive-behavior Therapy|"Behavioral: Cognitive-behavior therapy~Cognitive-behavior therapy: CBT: The components of CBT include (1) identification of idiosyncratic beliefs about pain and pain treatment, as well as reconceptualization of the pain experience as subject to personal control (sessions 1-2), (2) instruction in specific cognitive (e.g., distraction) and behavioral (e.g., change in activity patterns such as alternating activity with periods of rest) skills (sessions 3-8), and (3) consolidation of cognitive/behavioral skills through activities such as role playing (sessions 9-11)."
1191842|NCT00323271|P2|Participant Flow|Educational Intervention|"Interventional: Educational intervention~Interventional: Educational intervention: Session topics will include information on the etiology of MS, MS subtypes and disease progression, common symptoms of MS, medical management of MS, rehabilitation approaches to management of MS-related symptoms, exercise, sick day management, stress management, psychosocial adjustment, family involvement, and appropriate use of the health care system."
1191843|NCT00323271|P1|Participant Flow|Cognitive-behavior Therapy|"Behavioral: Cognitive-behavior therapy~Cognitive-behavior therapy: CBT: The components of CBT include (1) identification of idiosyncratic beliefs about pain and pain treatment, as well as reconceptualization of the pain experience as subject to personal control (sessions 1-2), (2) instruction in specific cognitive (e.g., distraction) and behavioral (e.g., change in activity patterns such as alternating activity with periods of rest) skills (sessions 3-8), and (3) consolidation of cognitive/behavioral skills through activities such as role playing (sessions 9-11)."
1191844|NCT00323271|O2|Outcome|Educational Intervention|"Interventional: Educational intervention~Interventional: Educational intervention: Session topics will include information on the etiology of MS, MS subtypes and disease progression, common symptoms of MS, medical management of MS, rehabilitation approaches to management of MS-related symptoms, exercise, sick day management, stress management, psychosocial adjustment, family involvement, and appropriate use of the health care system."
1191845|NCT00323271|O1|Outcome|Cognitive-behavior Therapy|"Behavioral: Cognitive-behavior therapy~Cognitive-behavior therapy: CBT: The components of CBT include (1) identification of idiosyncratic beliefs about pain and pain treatment, as well as reconceptualization of the pain experience as subject to personal control (sessions 1-2), (2) instruction in specific cognitive (e.g., distraction) and behavioral (e.g., change in activity patterns such as alternating activity with periods of rest) skills (sessions 3-8), and (3) consolidation of cognitive/behavioral skills through activities such as role playing (sessions 9-11)."
1191846|NCT00323271|O2|Outcome|Educational Intervention|"Interventional: Educational intervention~Interventional: Educational intervention: Session topics will include information on the etiology of MS, MS subtypes and disease progression, common symptoms of MS, medical management of MS, rehabilitation approaches to management of MS-related symptoms, exercise, sick day management, stress management, psychosocial adjustment, family involvement, and appropriate use of the health care system."
1191847|NCT00323271|O1|Outcome|Cognitive-behavior Therapy|"Behavioral: Cognitive-behavior therapy~Cognitive-behavior therapy: CBT: The components of CBT include (1) identification of idiosyncratic beliefs about pain and pain treatment, as well as reconceptualization of the pain experience as subject to personal control (sessions 1-2), (2) instruction in specific cognitive (e.g., distraction) and behavioral (e.g., change in activity patterns such as alternating activity with periods of rest) skills (sessions 3-8), and (3) consolidation of cognitive/behavioral skills through activities such as role playing (sessions 9-11)."
1191939|NCT00322712|B1|Baseline|Treatment Arm|Retrospective chart review for the period from 10/2005-8/2006 done on all patients with metastatic pancreatic cancer treated at the UNM Cancer Center with OIC (Oxaliplatin 60mg/m2, Irinotecan 90mg/m2, and Cetuximab 250 mg/m2 delivered every other week).
1191848|NCT00323271|E2|Reported Event|Educational Intervention|"Interventional: Educational intervention~Interventional: Educational intervention: Session topics will include information on the etiology of MS, MS subtypes and disease progression, common symptoms of MS, medical management of MS, rehabilitation approaches to management of MS-related symptoms, exercise, sick day management, stress management, psychosocial adjustment, family involvement, and appropriate use of the health care system."
1191849|NCT00323271|E1|Reported Event|Cognitive-behavior Therapy|"Behavioral: Cognitive-behavior therapy~Cognitive-behavior therapy: CBT: The components of CBT include (1) identification of idiosyncratic beliefs about pain and pain treatment, as well as reconceptualization of the pain experience as subject to personal control (sessions 1-2), (2) instruction in specific cognitive (e.g., distraction) and behavioral (e.g., change in activity patterns such as alternating activity with periods of rest) skills (sessions 3-8), and (3) consolidation of cognitive/behavioral skills through activities such as role playing (sessions 9-11)."
1191850|NCT00323258|B3|Baseline|Total|Total of all reporting groups
1191851|NCT00323258|B2|Baseline|Usual Care|"The usual care group received routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.~The control arm originally contained 72 subjects, 53 completed the 6 month follow-up phone call and 58 had refill records available at 6 months post-discharge. The periods listed here represent the same 6 month period with different numbers of particpants having the phone call or refill records available."
1191866|NCT00323258|E1|Reported Event|Intervention|Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
1191867|NCT00323193|B3|Baseline|Total|Total of all reporting groups
1191868|NCT00323193|B2|Baseline|Control Group|The control condition offers basic information about diet and exercise on a monthly basis.
1191852|NCT00323258|B1|Baseline|Intervention Arm|"Patients enrolled in the intervention arm received inpatient education on the importance of medication and assessment of barriers to adherence. A pill box, pocket medication card, and tips for remembering to take medications were provided. The community pharmacist was notified of the subject's enrollment. The community pharmacist was asked to reinforce importance of evidence-based medications and assess the subject's medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.~The intervention arm originally contained 71 subjects, 55 completed the 6 month follow-up phone call and 57 had refill records available at 6 months post-discharge. The periods listed here represent the same 6 month period with different numbers of particpants having the phone call or refill records available."
1191853|NCT00323258|P2|Participant Flow|Usual Care|"The usual care group received routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.~The control arm originally contained 72 subjects, 53 completed the 6 month follow-up phone call and 58 had refill records available at 6 months post-discharge. The periods listed here represent the same 6 month period with different numbers of particpants having the phone call or refill records available."
1191854|NCT00323258|P1|Participant Flow|Intervention Arm|"Patients enrolled in the intervention arm received inpatient education on the importance of medication and assessment of barriers to adherence. A pill box, pocket medication card, and tips for remembering to take medications were provided. The community pharmacist was notified of the subject's enrollment. The community pharmacist was asked to reinforce importance of evidence-based medications and assess the subject's medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.~The intervention arm originally contained 71 subjects, 55 completed the 6 month follow-up phone call and 57 had refill records available at 6 months post-discharge. The periods listed here represent the same 6 month period with different numbers of particpants having the phone call or refill records available."
1191855|NCT00323258|O2|Outcome|Usual Care|Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
1191856|NCT00323258|O1|Outcome|Intervention|Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
1191857|NCT00323258|O2|Outcome|Usual Care|Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
1191858|NCT00323258|O1|Outcome|Intervention|Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
1191859|NCT00323258|O2|Outcome|Usual Care|Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
1191860|NCT00323258|O1|Outcome|Intervention|Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
1191861|NCT00323258|O2|Outcome|Usual Care|Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
1192051|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
1191862|NCT00323258|O1|Outcome|Intervention|Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
1191863|NCT00323258|O2|Outcome|Usual Care|Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
1191864|NCT00323258|O1|Outcome|Intervention|Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
1191865|NCT00323258|E2|Reported Event|Usual Care|Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
1191869|NCT00323193|B1|Baseline|MOVE Group|"The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.~MOVE!: group based psychoeducation, motivation and support"
1191870|NCT00323193|P2|Participant Flow|Control Group|The control group offers basic information about diet and exercise every month for six months.
1191871|NCT00323193|P1|Participant Flow|MOVE Group|"The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.~MOVE!: group based psychoeducation, motivation and support"
1191872|NCT00323193|O2|Outcome|Control Group|The control group offers basic information about diet and exercise every month for six months.
1191873|NCT00323193|O1|Outcome|MOVE Group|"The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.~MOVE!: group based psychoeducation, motivation and support"
1191874|NCT00323193|O2|Outcome|Control Group|The control group offers basic information about diet and exercise every month for six months.
1191875|NCT00323193|O1|Outcome|MOVE Group|"The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.~MOVE!: group based psychoeducation, motivation and support"
1191876|NCT00323193|E2|Reported Event|Control Group|The control condition offers basic information about diet and exercise on a monthly basis.
1191877|NCT00323193|E1|Reported Event|MOVE Group|"The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.~MOVE!: group based psychoeducation, motivation and support"
1191878|NCT00323115|B1|Baseline|Vaccine|Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme (GBM) will be treated with radiotherapy and concurrent chemotherapy followed by intranodal vaccine with autologous dendritic cells (DCs) primed with tumor lysate. Adjuvant chemotherapy will be administered after vaccination for 1 year or until tumor progression
1191879|NCT00323115|P1|Participant Flow|Vaccine|Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme (GBM) will be treated with radiotherapy and concurrent chemotherapy followed by intranodal vaccine with autologous dendritic cells (DCs) primed with tumor lysate. Adjuvant chemotherapy will be administered after vaccination for 1 year or until tumor progression
1191880|NCT00323115|O1|Outcome|Vaccine|Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme (GBM) will be treated with radiotherapy and concurrent chemotherapy followed by intranodal vaccine with autologous dendritic cells (DCs) primed with tumor lysate. Adjuvant chemotherapy will be administered after vaccination for 1 year or until tumor progression
1191881|NCT00323115|O1|Outcome|Vaccine|Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme (GBM) will be treated with radiotherapy and concurrent chemotherapy followed by intranodal vaccine with autologous dendritic cells (DCs) primed with tumor lysate. Adjuvant chemotherapy will be administered after vaccination for 1 year or until tumor progression
1191882|NCT00323115|E1|Reported Event|Vaccine|Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme (GBM) will be treated with radiotherapy and concurrent chemotherapy followed by intranodal vaccine with autologous dendritic cells (DCs) primed with tumor lysate. Adjuvant chemotherapy will be administered after vaccination for 1 year or until tumor progression
1191883|NCT00323037|B3|Baseline|Total|Total of all reporting groups
1191884|NCT00323037|B2|Baseline|Coreg Controlled Release|
1191885|NCT00323037|B1|Baseline|Coreg Immediate Release|
1191886|NCT00323037|P2|Participant Flow|Coreg Controlled Release|
1191887|NCT00323037|P1|Participant Flow|Coreg Immediate Release|
1191888|NCT00323037|O2|Outcome|Coreg Controlled Release|
1191889|NCT00323037|O1|Outcome|Coreg Immediate Release|
1191890|NCT00322881|B1|Baseline|Carboplatin/Paclitaxel|Patients received chemotherapy on day 1 of a 21 day cycle for 6 cycles. Paclitaxel was given via peripheral or central IV catheter at the dose of 175 mg/m2 over 3 hours. IV carboplatin followed using a dose of Area Under the Curve (AUC) equal to 5 with creatinine clearance based on Jelliffe formula.
1191940|NCT00322712|P1|Participant Flow|Treatment Arm|Retrospective chart review for the period from 10/2005-8/2006 done on all patients with metastatic pancreatic cancer treated at the UNM Cancer Center with OIC (Oxaliplatin 60mg/m2, Irinotecan 90mg/m2, and Cetuximab 250 mg/m2 delivered every other week).
1191891|NCT00322881|P1|Participant Flow|Carboplatin/Paclitaxel|Patients received chemotherapy on day 1 of a 21 day cycle for 6 cycles. Paclitaxel was given via peripheral or central IV catheter at the dose of 175 mg/m2 over 3 hours. IV carboplatin followed using a dose of Area Under the Curve (AUC) equal to 5 with creatinine clearance based on Jelliffe formula.
1191892|NCT00322881|O1|Outcome|Carboplatin/Paclitaxel|Patients received chemotherapy on day 1 of a 21 day cycle for 6 cycles. Paclitaxel was given via peripheral or central IV catheter at the dose of 175 mg/m2 over 3 hours. IV carboplatin followed using a dose of Area Under the Curve (AUC) equal to 5 with creatinine clearance based on Jelliffe formula.
1191893|NCT00322881|E1|Reported Event|Carboplatin/Paclitaxel|"Paclitaxel: Chemotherapy will be given per standard treatment practices for 6 cycles (18 weeks)~Carboplatin: Chemotherapy will be given per standard treatment practices for 6 cycles (18 weeks)"
1191894|NCT00322855|B1|Baseline|Chart Review|patients diagnosed with soft tissue sarcoma
1191895|NCT00322855|P1|Participant Flow|Chart Review|patients diagnosed with soft tissue sarcoma
1191896|NCT00322855|O1|Outcome|Chart Review|patients diagnosed with soft tissue sarcoma
1191897|NCT00322855|E1|Reported Event|Chart Review|patients diagnosed with soft tissue sarcoma
1191898|NCT00322842|B3|Baseline|Total|Total of all reporting groups
1191899|NCT00322842|B2|Baseline|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1191900|NCT00322842|B1|Baseline|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1191955|NCT00322621|O4|Outcome|Rescue Arm|duloxetine 120 mg once daily
1192468|NCT00321906|O1|Outcome|Azathioprine|(tacrolimus,azathioprine/prednisone)
1191901|NCT00322842|P2|Participant Flow|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1191902|NCT00322842|P1|Participant Flow|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1191903|NCT00322842|O3|Outcome|All Participants|
1191904|NCT00322842|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1191905|NCT00322842|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1191906|NCT00322842|O3|Outcome|All Participants|
1191907|NCT00322842|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1191908|NCT00322842|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1191909|NCT00322842|O3|Outcome|All Participants|
1191910|NCT00322842|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1191911|NCT00322842|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1191912|NCT00322842|O3|Outcome|All Participants|
1191913|NCT00322842|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1191914|NCT00322842|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1191915|NCT00322842|O3|Outcome|All Participants|
1191998|NCT00322556|P1|Participant Flow|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
1191916|NCT00322842|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1191917|NCT00322842|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1191918|NCT00322842|O3|Outcome|All Participants|
1191919|NCT00322842|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1191920|NCT00322842|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1191921|NCT00322842|O3|Outcome|All Participants|
1191922|NCT00322842|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1191923|NCT00322842|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1191924|NCT00322842|E2|Reported Event|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1191925|NCT00322842|E1|Reported Event|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1191926|NCT00322777|B3|Baseline|Total|Total of all reporting groups
1191927|NCT00322777|B2|Baseline|Waitlist Control Group|Arm where participants began the intervention (the Spirituality Teaching Program) after an 8 week wait period. Therefore, the program was initiated at week 8 of the trial. Between week 1 and week 8, participants were instructed to carry out their day to day activities as before.
1191928|NCT00322777|B1|Baseline|Spirituality Group|Arm where participants began the intervention (the Spirituality Teaching Program) upon recruitment for an 8 week period. Therefore, the program was initiated at week 1 of the trial.
1191929|NCT00322777|P2|Participant Flow|Waitlist Control Group|Arm where participants began the intervention (the Spirituality Teaching Program) after an 8 week wait period. Therefore, the program was initiated at week 8 of the trial. Between week 1 and week 8, participants were instructed to carry out their day to day activities as before.
1191930|NCT00322777|P1|Participant Flow|Spirituality Group|Arm where participants began the intervention (the Spirituality Teaching Program) upon recruitment for an 8 week period. Therefore, the program was initiated at week 1 of the trial.
1191931|NCT00322777|O2|Outcome|Waitlist Control Group|Arm where participants began the intervention (the Spirituality Teaching Program) after an 8 week wait period. Therefore, the program was initiated at week 8 of the trial. Between week 1 and week 8, participants were instructed to carry out their day to day activities as before.
1191932|NCT00322777|O1|Outcome|Spirituality Group|Arm where participants began the intervention (the Spirituality Teaching Program) upon recruitment for an 8 week period. Therefore, the program was initiated at week 1 of the trial.
1191933|NCT00322777|O2|Outcome|Waitlist Control Group|Arm where participants began the intervention (the Spirituality Teaching Program) after an 8 week wait period. Therefore, the program was initiated at week 8 of the trial. Between week 1 and week 8, participants were instructed to carry out their day to day activities as before.
1191934|NCT00322777|O1|Outcome|Spirituality Group|Arm where participants began the intervention (the Spirituality Teaching Program) upon recruitment for an 8 week period. Therefore, the program was initiated at week 1 of the trial.
1191935|NCT00322777|O2|Outcome|Waitlist Control Group|Arm where participants began the intervention (the Spirituality Teaching Program) after an 8 week wait period. Therefore, the program was initiated at week 8 of the trial. Between week 1 and week 8, participants were instructed to carry out their day to day activities as before.
1191936|NCT00322777|O1|Outcome|Spirituality Group|Arm where participants began the intervention (the Spirituality Teaching Program) upon recruitment for an 8 week period. Therefore, the program was initiated at week 1 of the trial.
1191937|NCT00322777|E2|Reported Event|Waitlist Control Group|Arm where participants began the intervention (the Spirituality Teaching Program) after an 8 week wait period. Therefore, the program was initiated at week 8 of the trial. Between week 1 and week 8, participants were instructed to carry out their day to day activities as before.
1191938|NCT00322777|E1|Reported Event|Spirituality Group|Arm where participants began the intervention (the Spirituality Teaching Program) upon recruitment for an 8 week period. Therefore, the program was initiated at week 1 of the trial.
1192139|NCT00322452|E2|Reported Event|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
1191941|NCT00322712|O1|Outcome|Treatment Arm|Retrospective chart review for the period from 10/2005-8/2006 done on all patients with metastatic pancreatic cancer treated at the UNM Cancer Center with OIC (Oxaliplatin 60mg/m2, Irinotecan 90mg/m2, and Cetuximab 250 mg/m2 delivered every other week).
1191942|NCT00322712|E1|Reported Event|Treatment Arm|Retrospective chart review for the period from 10/2005-8/2006 done on all patients with metastatic pancreatic cancer treated at the UNM Cancer Center with OIC (Oxaliplatin 60mg/m2, Irinotecan 90mg/m2, and Cetuximab 250 mg/m2 delivered every other week).
1191943|NCT00322621|B1|Baseline|Acute Phase|All subjects receive 30 milligrams (mg) duloxetine once daily (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 7 weeks, then maintenance at 60 mg QD, PO for responders to 6 months and rescue at 120 mg QD, PO for non-responders to 6 months
1191944|NCT00322621|P3|Participant Flow|Rescue Arm|Duloxetine: 120 milligrams once daily.
1191945|NCT00322621|P2|Participant Flow|Maintenance Arm|Duloxetine: 60 milligrams once daily.
1191946|NCT00322621|P1|Participant Flow|Acute Phase|All subjects receive 30 milligrams (mg) duloxetine once daily (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 7 weeks, then maintenance at 60 mg QD, PO for responders to 6 months and rescue at 120 mg QD, PO for non-responders to 6 months.
1191947|NCT00322621|O2|Outcome|Duloxetine 120 mg|Duloxetine: 120 milligrams once daily
1191948|NCT00322621|O1|Outcome|Duloxetine 60 mg|Duloxetine: 60 milligrams once daily
1191949|NCT00322621|O2|Outcome|Duloxetine 120 mg|Duloxetine: 120 milligrams once daily
1191950|NCT00322621|O1|Outcome|Duloxetine 60 mg|Duloxetine: 60 milligrams once daily
1191951|NCT00322621|O2|Outcome|Duloxetine 120 mg|Duloxetine: 120 milligrams once daily
1191952|NCT00322621|O1|Outcome|Duloxetine 60 mg|Duloxetine: 60 milligrams once daily
1191953|NCT00322621|O2|Outcome|Duloxetine 120 mg|Duloxetine: 120 milligrams once daily
1191954|NCT00322621|O1|Outcome|Duloxetine 60 mg|Duloxetine: 60 milligrams once daily
1191956|NCT00322621|O3|Outcome|Maintenance Arm (Later Dose Increase)|duloxetine 60 mg once daily and then increasing to 120 mg once daily
1191957|NCT00322621|O2|Outcome|Maintenance Arm (No Dose Increase)|duloxetine 60 mg once daily
1191958|NCT00322621|O1|Outcome|All Maintenance / Rescue Participants|Total of the Maintenance (No Dose Increase), Maintenance (Later Dose Increase) and Rescue arms. Depending on the group the patient was in, they either received duloxetine 60 mg once daily; 60 mg once daily and then increased to 120 mg once daily; or 120 mg once daily.
1191959|NCT00322621|O1|Outcome|Acute Phase|All subjects receive 30 milligrams (mg) duloxetine once daily (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 7 weeks, then maintenance at 60 mg QD, PO for responders to 6 months and rescue at 120 mg QD, PO for non-responders to 6 months
1191960|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
1191961|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
1191962|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
1191963|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
1191964|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
1191965|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
1191966|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
1191967|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
1191968|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
1191969|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
1191970|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
1191971|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
1191972|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
1191973|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
1191974|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
1191975|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
1191976|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
1191977|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
1191978|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
1191979|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
1191980|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
1191981|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
1191982|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
1191983|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
1191984|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
1191985|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
1191986|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
1191987|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
1191988|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
1191989|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
1191990|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
1191991|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
1191992|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
1191993|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
1191994|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
1191995|NCT00322621|E2|Reported Event|Duloxetine 120 mg|Duloxetine: 120 milligrams once daily
1191996|NCT00322621|E1|Reported Event|Duloxetine 60 mg|Duloxetine: 60 milligrams once daily
1191997|NCT00322556|B1|Baseline|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
1192052|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
1192000|NCT00322556|O1|Outcome|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
1192001|NCT00322556|O1|Outcome|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
1192002|NCT00322556|O1|Outcome|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
1192003|NCT00322556|O1|Outcome|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
1192004|NCT00322556|O1|Outcome|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
1192005|NCT00322556|O1|Outcome|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
1192006|NCT00322556|O3|Outcome|IgPro10 (> 8 to ≤ 12 mg/kg/Min)|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the high maximum infusion rate (> 8 and ≤ 12 mg/kg/min) for old subjects.
1192007|NCT00322556|O2|Outcome|IgPro10 (≤ 8 mg/kg/Min)|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the low maximum infusion rate (≤ 8 mg/kg/min) for old subjects.
1192064|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
1192008|NCT00322556|O1|Outcome|IgPro10 (≤ 4 mg/kg/Min)|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the maximum infusion rate (≤ 4 mg/kg/min) for new subjects.
1192009|NCT00322556|O1|Outcome|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
1192010|NCT00322556|E1|Reported Event|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
1192011|NCT00322491|B3|Baseline|Total|Total of all reporting groups
1192012|NCT00322491|B2|Baseline|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1192013|NCT00322491|B1|Baseline|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1192014|NCT00322491|P2|Participant Flow|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1192015|NCT00322491|P1|Participant Flow|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1192016|NCT00322491|O3|Outcome|All Participants|
1192017|NCT00322491|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1192018|NCT00322491|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1192019|NCT00322491|O3|Outcome|All Participants|
1192020|NCT00322491|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1192021|NCT00322491|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1192022|NCT00322491|O3|Outcome|All Participants|
1192023|NCT00322491|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1192136|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
1192140|NCT00322452|E1|Reported Event|Gefitinib|Gefitinib 250mg daily
1192024|NCT00322491|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1192025|NCT00322491|O3|Outcome|All Participants|
1192026|NCT00322491|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1192027|NCT00322491|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1192028|NCT00322491|O3|Outcome|All Participants|
1192029|NCT00322491|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1192065|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
1192030|NCT00322491|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1192031|NCT00322491|O3|Outcome|All Participants|
1192032|NCT00322491|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1192033|NCT00322491|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1192034|NCT00322491|E2|Reported Event|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1192035|NCT00322491|E1|Reported Event|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1192036|NCT00322465|B5|Baseline|Total|Total of all reporting groups
1192037|NCT00322465|B4|Baseline|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
1192038|NCT00322465|B3|Baseline|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
1192039|NCT00322465|B2|Baseline|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
1192040|NCT00322465|B1|Baseline|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
1192041|NCT00322465|P4|Participant Flow|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
1192042|NCT00322465|P3|Participant Flow|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
1192043|NCT00322465|P2|Participant Flow|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
1192044|NCT00322465|P1|Participant Flow|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
1192045|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
1192046|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
1192047|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
1192048|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
1192049|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
1192050|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
1192053|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
1192054|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
1192055|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
1192056|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
1192057|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
1192058|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
1192059|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
1192060|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
1192061|NCT00322465|O1|Outcome|All Participants Analyzed|
1192062|NCT00322465|O1|Outcome|All Participants Analyzed|
1192063|NCT00322465|O1|Outcome|All Participants Analyzed|
1192066|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
1192067|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
1192068|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
1192069|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
1192070|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
1192071|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
1192072|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
1192073|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
1192074|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
1192075|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
1192076|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
1192077|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
1192078|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
1192079|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
1192080|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
1192081|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
1192082|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
1192083|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
1192084|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
1192085|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
1192086|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
1192087|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
1192137|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
1192138|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
1192088|NCT00322465|O2|Outcome|Azithromycin + (Azithromycin + Tinidazole)|Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole placebo single dose + (Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole single dose (4 tablets at 500 mg each))
1192089|NCT00322465|O1|Outcome|Doxycycline + (Doxycycline + Tinidazole)|Doxycycline 100 mg PO BID (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin PO single dose and placebo tinidazole + (Doxycycline 100 mg PO BID for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm PO single dose (4 tablets at 500 mg each)).
1192090|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
1192091|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
1192092|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
1192093|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
1192094|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
1192095|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
1192096|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
1192097|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
1192098|NCT00322465|E4|Reported Event|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
1192099|NCT00322465|E3|Reported Event|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
1192100|NCT00322465|E2|Reported Event|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
1192101|NCT00322465|E1|Reported Event|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
1192102|NCT00322452|B3|Baseline|Total|Total of all reporting groups
1192103|NCT00322452|B2|Baseline|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
1192104|NCT00322452|B1|Baseline|Gefitinib|Gefitinib 250mg daily
1192105|NCT00322452|P2|Participant Flow|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
1192106|NCT00322452|P1|Participant Flow|Gefitinib|Gefitinib 250mg daily
1192107|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
1192108|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
1192109|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
1192110|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
1192111|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
1192112|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
1192113|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
1192114|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
1192115|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
1192116|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
1192117|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
1192118|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
1192119|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
1192120|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
1192121|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
1192122|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
1192123|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
1192124|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
1192125|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
1192126|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
1192127|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
1192128|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
1192129|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
1192130|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
1192131|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
1192132|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
1192133|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
1192134|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
1192135|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
1192141|NCT00322439|B1|Baseline|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
1192142|NCT00322439|P1|Participant Flow|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
1192143|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
1192144|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
1192145|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
1192469|NCT00321906|O2|Outcome|Sirolimus|tacrolimus/sirolimus/prednisone
1192146|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
1192147|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
1192148|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
1192149|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
1192150|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
1192151|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
1192152|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
1192153|NCT00322439|E1|Reported Event|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
1192154|NCT00322387|B3|Baseline|Total|Total of all reporting groups
1192155|NCT00322387|B2|Baseline|Multiple Myeloma (MM)|Participants with multiple myeloma were assigned to any of the 4 treatment arms.
1192156|NCT00322387|B1|Baseline|Non-Hodgkin's Lymphoma (NHL)|Participants with non-Hodgkin's lymphoma were assigned to Plerixafor PM, Plerixafor AM, and Plerixafor After Chemo treatment arms.
1192157|NCT00322387|P2|Participant Flow|Multiple Myeloma (MM)|Participants with multiple myeloma were assigned to any of the 4 treatment arms.
1192158|NCT00322387|P1|Participant Flow|Non-Hodgkin's Lymphoma (NHL)|Participants with non-Hodgkin's lymphoma were assigned to Plerixafor PM, Plerixafor AM, and Plerixafor After Chemo treatment arms.
1192207|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192208|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192556|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192159|NCT00322387|O7|Outcome|Multiple Myeloma (MM): Plerixafor After Chemo|"Participants with MM who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.~Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
1192160|NCT00322387|O6|Outcome|Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM|Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days.
1192161|NCT00322387|O5|Outcome|Multiple Myeloma (MM): Plerixafor AM|Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
1192221|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192470|NCT00321906|O1|Outcome|Azathioprine|(tacrolimus,azathioprine/prednisone)
1192162|NCT00322387|O4|Outcome|Multiple Myeloma (MM): Plerixafor PM|Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
1192163|NCT00322387|O3|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo|"Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.~Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
1192164|NCT00322387|O2|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor AM|Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
1192165|NCT00322387|O1|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor PM|Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
1192166|NCT00322387|O7|Outcome|Multiple Myeloma (MM): Plerixafor After Chemo|"Participants with MM who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.~Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
1192167|NCT00322387|O6|Outcome|Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM|Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days.
1192168|NCT00322387|O5|Outcome|Multiple Myeloma (MM): Plerixafor AM|Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
1192169|NCT00322387|O4|Outcome|Multiple Myeloma (MM): Plerixafor PM|Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
1192209|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192210|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192170|NCT00322387|O3|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo|"Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.~Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
1192171|NCT00322387|O2|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor AM|Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
1192172|NCT00322387|O1|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor PM|Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
1192173|NCT00322387|O8|Outcome|All Participants|
1192174|NCT00322387|O7|Outcome|Multiple Myeloma (MM): Plerixafor After Chemo|"Participants with MM who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.~Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
1192175|NCT00322387|O6|Outcome|Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM|Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days.
1192176|NCT00322387|O5|Outcome|Multiple Myeloma (MM): Plerixafor AM|Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
1192177|NCT00322387|O4|Outcome|Multiple Myeloma (MM): Plerixafor PM|Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
1192178|NCT00322387|O3|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo|"Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.~Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
1192179|NCT00322387|O2|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor AM|Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
1192180|NCT00322387|O1|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor PM|Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
1192181|NCT00322387|E7|Reported Event|Multiple Myeloma (MM): Plerixafor After Chemo|"Participants with MM who followed the Plerixafor After Chemo treatment arm regimen.~Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
1192211|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192212|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192182|NCT00322387|E6|Reported Event|Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM|"Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen.~Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was adminstered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days."
1192183|NCT00322387|E5|Reported Event|Multiple Myeloma (MM): Plerixafor AM|Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
1192184|NCT00322387|E4|Reported Event|Multiple Myeloma (MM): Plerixafor PM|Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
1192471|NCT00321906|O2|Outcome|Sirolimus|tacrolimus/sirolimus/prednisone
1192185|NCT00322387|E3|Reported Event|Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo|"Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen.~Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
1192186|NCT00322387|E2|Reported Event|Non-Hodgkin's Lymphoma (NHL): Plerixafor AM|Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
1192187|NCT00322387|E1|Reported Event|Non-Hodgkin's Lymphoma (NHL): Plerixafor PM|Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
1192188|NCT00322374|B4|Baseline|Total|Total of all reporting groups
1192189|NCT00322374|B3|Baseline|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192190|NCT00322374|B2|Baseline|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192191|NCT00322374|B1|Baseline|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192192|NCT00322374|P4|Participant Flow|All Participants|
1192193|NCT00322374|P3|Participant Flow|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192194|NCT00322374|P2|Participant Flow|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192195|NCT00322374|P1|Participant Flow|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192196|NCT00322374|O2|Outcome|All Response-evaluable Participants|Participants treated at the MTD with a best response of either CR or PR.
1192197|NCT00322374|O1|Outcome|All Participants With Measurable Disease and Tumor Response|All participants with measurable disease and with a best tumor response of either CR or PR.
1192198|NCT00322374|O2|Outcome|All Response-evaluable Participants|Participants treated at the MTD with a best response of either CR or PR.
1192199|NCT00322374|O1|Outcome|All Participants With Measurable Disease and Tumor Response|All participants with measurable disease and with a best tumor response of either CR or PR.
1192200|NCT00322374|O2|Outcome|All Response-evaluable Participants|Participants treated at the MTD with measurable disease at baseline per RECIST
1192201|NCT00322374|O1|Outcome|All Participants With Measurable Disease|Participants with measurable disease at baseline per RECIST
1192202|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192203|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192204|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192205|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192206|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192213|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192214|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192215|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192216|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192217|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192218|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192219|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192220|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192222|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192223|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192224|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192225|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192226|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192227|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192228|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192229|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192230|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192231|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192232|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192233|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192234|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192235|NCT00322374|O1|Outcome|All Participants With Measurable Disease and Tumor Response|All participants received Ixabepilone administered as a 3-hour IV infusion following a 3- to 5-minute IV infusion of Epirubicin every 21 days.
1192236|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192237|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192238|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192239|NCT00322374|E3|Reported Event|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192240|NCT00322374|E2|Reported Event|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192241|NCT00322374|E1|Reported Event|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
1192242|NCT00322348|B3|Baseline|Total|Total of all reporting groups
1192243|NCT00322348|B2|Baseline|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
1192244|NCT00322348|B1|Baseline|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
1192245|NCT00322348|P2|Participant Flow|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
1192246|NCT00322348|P1|Participant Flow|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
1192247|NCT00322348|O2|Outcome|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
1192248|NCT00322348|O1|Outcome|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
1192249|NCT00322348|O2|Outcome|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
1192250|NCT00322348|O1|Outcome|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
1192251|NCT00322348|O2|Outcome|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
1192252|NCT00322348|O1|Outcome|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
1192253|NCT00322348|O2|Outcome|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
1192254|NCT00322348|O1|Outcome|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
1192255|NCT00322348|O2|Outcome|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
1192256|NCT00322348|O1|Outcome|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
1192257|NCT00322348|O2|Outcome|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
1192258|NCT00322348|O1|Outcome|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
1192259|NCT00322348|E2|Reported Event|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
1192260|NCT00322348|E1|Reported Event|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
1192261|NCT00322335|B4|Baseline|Total|Total of all reporting groups
1192262|NCT00322335|B3|Baseline|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
1192263|NCT00322335|B2|Baseline|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
1192264|NCT00322335|B1|Baseline|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
1192265|NCT00322335|P3|Participant Flow|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
1192266|NCT00322335|P2|Participant Flow|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
1192267|NCT00322335|P1|Participant Flow|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
1192268|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
1192269|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
1192316|NCT00322309|O1|Outcome|Mirtazapine|"Mirtazapine daily:~Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg"
1192317|NCT00322309|O2|Outcome|Placebo|Subjects received matched placebo capsules
1192318|NCT00322309|O1|Outcome|Mirtazapine|"Mirtazapine daily:~Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg"
1192270|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
1192271|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
1192272|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
1192406|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
1192472|NCT00321906|O1|Outcome|Azathioprine|(tacrolimus,azathioprine/prednisone)
1192273|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
1192274|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
1192275|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
1192276|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
1192277|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
1192278|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
1192279|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
1192280|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
1192281|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
1192319|NCT00322309|E2|Reported Event|Placebo|Matched placebo
1192610|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192282|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
1192283|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
1192284|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
1192285|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
1192286|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
1192287|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
1192288|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
1192289|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
1192290|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
1192291|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
1192292|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
1192293|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
1192320|NCT00322309|E1|Reported Event|Mirtazapine Daily: Days 1-4 15mg Days 5-9 30mg Mirtazapine|"Mirtazapine daily:~Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg"
1192294|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
1192295|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
1192296|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
1192297|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
1192298|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
1192299|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
1192300|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
1192301|NCT00322335|E3|Reported Event|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
1192302|NCT00322335|E2|Reported Event|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
1192303|NCT00322335|E1|Reported Event|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
1192304|NCT00322309|B3|Baseline|Total|Total of all reporting groups
1192305|NCT00322309|B2|Baseline|Placebo|Subjects received matched placebo capsules
1192306|NCT00322309|B1|Baseline|Mirtazapine|"Mirtazapine daily:~Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg"
1192307|NCT00322309|P2|Participant Flow|Placebo|Matched placebo given daily days 1-84
1192308|NCT00322309|P1|Participant Flow|Mirtazapine|"Mirtazapine daily:~Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg"
1192309|NCT00322309|O2|Outcome|Placebo|Matched placebo given daily days 1-84
1192310|NCT00322309|O1|Outcome|Mirtazapine|"Mirtazapine daily:~Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg"
1192311|NCT00322309|O2|Outcome|Placebo|Matched placebo given daily days 1-84
1192312|NCT00322309|O1|Outcome|Mirtazapine|"Mirtazapine daily:~Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg"
1192313|NCT00322309|O2|Outcome|Placebo|Matched placebo capsules
1192314|NCT00322309|O1|Outcome|Mirtazepine|"Mirtazapine daily:~Days 1-4 15mg Days 5-9 30mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg"
1192315|NCT00322309|O2|Outcome|Placebo|Subjects received matched placebo capsules
1192321|NCT00322231|B3|Baseline|Total|Total of all reporting groups
1192322|NCT00322231|B2|Baseline|Placebo / ZOSTAVAX™|0.65mL of placebo injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of Zoster vaccine live injected subcutaneously at Week 4 (Period 2)
1192323|NCT00322231|B1|Baseline|ZOSTAVAX™ / Placebo|0.65mL of Zoster vaccine live injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of placebo injected subcutaneously at Week 4 (Period 2)
1192324|NCT00322231|P2|Participant Flow|Placebo / ZOSTAVAX™|0.65mL of placebo injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of Zoster vaccine live injected subcutaneously at Week 4 (Period 2)
1192325|NCT00322231|P1|Participant Flow|ZOSTAVAX™ / Placebo|0.65mL of Zoster vaccine live injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of placebo injected subcutaneously at Week 4 (Period 2)
1192326|NCT00322231|O2|Outcome|Placebo|Participants included in this analysis were those who received Placebo in Placebo /ZOSTAVAX™ group (on Day 1). Participants who received ZOSTAVAX™ in the ZOSTAVAX™ / Placebo group were excluded in order to avoid a possible carry-over effect of ZOSTAVAX™ on immunogenicity measurements. In addition, 5 participants from the Placebo / ZOSTAVAX™ group were excluded in the prevaccination summaries (since their specimens were damaged or collected out of day range), and are not in the analysis.
1192327|NCT00322231|O1|Outcome|ZOSTAVAX™|Participants who received ZOSTAVAX™ in both, the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ group are included. In addition, 5 participants from the Placebo / ZOSTAVAX™ group were excluded in the prevaccination summaries (since their specimens were damaged or collected out of day range), and are not in the analysis.
1192328|NCT00322231|O2|Outcome|Placebo|Participants who received placebo (at Day 1) in Placebo / ZOSTAVAX™ group. Participants who received ZOSTAVAX™ at (Day 1) in the ZOSTAVAX™ / Placebo group were excluded to avoid a possible carry-over effect of ZOSTAVAX™ on immunogenicity measurements.
1192329|NCT00322231|O1|Outcome|ZOSTAVAX™|Participants who received ZOSTAVAX™ in both, the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ group (see participant flow section) are included.
1192330|NCT00322231|O2|Outcome|Placebo|Participants who received placebo in the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ Group (see participant flow section) are included.
1192331|NCT00322231|O1|Outcome|ZOSTAVAX™|Participants who received ZOSTAVAX™ in the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ group (see participant flow section) are included
1192332|NCT00322231|E2|Reported Event|Placebo|All participants that received Placebo in both, the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™. Five participants that received placebo were lost to follow up and not included in the analysis.
1192333|NCT00322231|E1|Reported Event|ZOSTAVAX™|All participants that received ZOSTAVAX™ from both, the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ group. Two participants that received ZOSTAVAX™ were lost to follow up and not included in the analysis.
1192334|NCT00322153|B3|Baseline|Total|Total of all reporting groups
1192335|NCT00322153|B2|Baseline|Memantine ER|28mg once daily oral administration for 24 weeks.
1192336|NCT00322153|B1|Baseline|Placebo|Matching placebo oral administration once daily for 24 weeks.
1192337|NCT00322153|P2|Participant Flow|Memantine ER|28mg once daily oral administration for 24 weeks.
1192338|NCT00322153|P1|Participant Flow|Placebo|Matching placebo oral administration once daily for 24 weeks.
1192339|NCT00322153|O2|Outcome|Memantine ER|28mg once daily oral administration for 24 weeks.
1192340|NCT00322153|O1|Outcome|Placebo|Matching placebo oral administration once daily for 24 weeks.
1192341|NCT00322153|O2|Outcome|Memantine ER|28mg once daily oral administration for 24 weeks.
1192342|NCT00322153|O1|Outcome|Placebo|Matching placebo oral administration once daily for 24 weeks.
1192343|NCT00322153|O2|Outcome|Memantine ER|28mg once daily oral administration for 24 weeks.
1192344|NCT00322153|O1|Outcome|Placebo|Matching placebo oral administration once daily for 24 weeks.
1192345|NCT00322153|E2|Reported Event|Memantine ER|28mg once daily oral administration for 24 weeks.
1192346|NCT00322153|E1|Reported Event|Placebo|Matching placebo oral administration once daily for 24 weeks.
1192347|NCT00322101|B3|Baseline|Total|Total of all reporting groups
1192348|NCT00322101|B2|Baseline|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.~Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.~Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.~TRANSPLANTATION: Patients undergo PBSC infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
1192349|NCT00322101|B1|Baseline|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
1192350|NCT00322101|P2|Participant Flow|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.~Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.~Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.~TRANSPLANTATION: Patients undergo PBSC infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
1192351|NCT00322101|P1|Participant Flow|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
1195586|NCT00313144|O3|Outcome|>6 Months to ≤12 Months|
1192352|NCT00322101|O2|Outcome|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.~Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.~Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.~TRANSPLANTATION: Patients undergo PBSC infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
1192353|NCT00322101|O1|Outcome|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
1192407|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV)( over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
1192408|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
1192473|NCT00321906|O2|Outcome|Sirolimus|tacrolimus/sirolimus/prednisone
1192354|NCT00322101|O2|Outcome|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.~Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.~Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.~TRANSPLANTATION: Patients undergo PBSC infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
1192355|NCT00322101|O1|Outcome|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
1192356|NCT00322101|O2|Outcome|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.~Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.~Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.~TRANSPLANTATION: Patients undergo PBSC infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
1192357|NCT00322101|O1|Outcome|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
1192358|NCT00322101|O2|Outcome|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.~Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.~Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.~TRANSPLANTATION: Patients undergo PBSC infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
1192359|NCT00322101|O1|Outcome|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
1192360|NCT00322101|O2|Outcome|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.~Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.~Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.~TRANSPLANTATION: Patients undergo PBSC infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
1192361|NCT00322101|O1|Outcome|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
1192362|NCT00322101|O2|Outcome|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.~Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.~Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.~TRANSPLANTATION: Patients undergo PBSC infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
1192399|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
1192400|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
1195587|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
1192363|NCT00322101|O1|Outcome|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
1192364|NCT00322101|E2|Reported Event|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.~Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.~Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.~TRANSPLANTATION: Patients undergo PBSC infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
1192365|NCT00322101|E1|Reported Event|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
1192366|NCT00321984|B4|Baseline|Total|Total of all reporting groups
1192367|NCT00321984|B3|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
1192368|NCT00321984|B2|Baseline|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
1192369|NCT00321984|B1|Baseline|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
1192370|NCT00321984|P3|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
1192371|NCT00321984|P2|Participant Flow|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
1192372|NCT00321984|P1|Participant Flow|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
1192373|NCT00321984|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
1192374|NCT00321984|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
1192375|NCT00321984|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
1192376|NCT00321984|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
1192377|NCT00321984|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
1192378|NCT00321984|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
1192379|NCT00321984|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
1192380|NCT00321984|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
1192381|NCT00321984|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
1192382|NCT00321984|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
1192383|NCT00321984|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
1192384|NCT00321984|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
1192385|NCT00321984|E3|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
1192386|NCT00321984|E2|Reported Event|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
1192387|NCT00321984|E1|Reported Event|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
1192388|NCT00321932|B3|Baseline|Total|Total of all reporting groups
1192389|NCT00321932|B2|Baseline|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid IV over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
1192390|NCT00321932|B1|Baseline|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
1192391|NCT00321932|P2|Participant Flow|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid IV over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
1192392|NCT00321932|P1|Participant Flow|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
1192393|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
1192394|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
1192395|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
1192396|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
1192397|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
1192398|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
1192553|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1195588|NCT00313144|O1|Outcome|Baseline|
1192401|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
1192402|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
1192403|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
1192404|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
1192405|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
1199147|NCT00301262|O2|Outcome|DB Placebo / OL Viagra|
1192409|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
1192410|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
1192411|NCT00321932|E2|Reported Event|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid IV over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
1192412|NCT00321932|E1|Reported Event|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
1192413|NCT00321919|B3|Baseline|Total|Total of all reporting groups
1192414|NCT00321919|B2|Baseline|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
1192415|NCT00321919|B1|Baseline|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
1192416|NCT00321919|P2|Participant Flow|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL has occurred in order to reach a target Hb of 10.5-11.5 g/dL.
1192417|NCT00321919|P1|Participant Flow|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hemoglobin (Hb) level of 13-15 gram/decilitre (g/dL) with an individual Hb increase of at least 2 g/dL within approximately 3 months.
1192418|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
1192419|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
1192420|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
1192421|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
1192422|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
1192423|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
1192424|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
1192425|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
1192426|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
1192427|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
1192428|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
1192554|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1193431|NCT00320190|O1|Outcome|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
1192429|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
1192430|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
1192431|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
1192432|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
1192433|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
1192434|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
1192435|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
1192436|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
1192437|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months
1192438|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
1192439|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
1192440|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
1192441|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
1192442|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
1192443|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
1192444|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
1192445|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
1192446|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
1192447|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
1192448|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
1192449|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
1192450|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
1192451|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
1192452|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
1192453|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
1193432|NCT00320190|O2|Outcome|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
1192454|NCT00321919|E2|Reported Event|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
1192455|NCT00321919|E1|Reported Event|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
1192456|NCT00321906|B3|Baseline|Total|Total of all reporting groups
1192457|NCT00321906|B2|Baseline|Sirolimus|tacrolimus/sirolimus/prednisone
1192458|NCT00321906|B1|Baseline|Azathioprine|(tacrolimus,azathioprine/prednisone)
1192459|NCT00321906|P2|Participant Flow|Sirolimus|tacrolimus/sirolimus/prednisone
1192460|NCT00321906|P1|Participant Flow|Azathioprine|(tacrolimus,azathioprine/prednisone)
1192461|NCT00321906|O2|Outcome|Sirolimus|tacrolimus/sirolimus/prednisone
1192462|NCT00321906|O1|Outcome|Azathioprine|(tacrolimus,azathioprine/prednisone)
1192463|NCT00321906|O2|Outcome|Sirolimus|tacrolimus/sirolimus/prednisone
1192464|NCT00321906|O1|Outcome|Azathioprine|(tacrolimus,azathioprine/prednisone)
1192465|NCT00321906|O2|Outcome|Sirolimus|tacrolimus/sirolimus/prednisone
1192466|NCT00321906|O1|Outcome|Azathioprine|(tacrolimus,azathioprine/prednisone)
1192467|NCT00321906|O2|Outcome|Sirolimus|tacrolimus/sirolimus/prednisone
1192474|NCT00321906|O1|Outcome|Azathioprine|(tacrolimus,azathioprine/prednisone)
1192475|NCT00321906|O2|Outcome|Sirolimus|tacrolimus/sirolimus/prednisone
1192476|NCT00321906|O1|Outcome|Azathioprine|(tacrolimus,azathioprine/prednisone)
1192477|NCT00321906|E2|Reported Event|Sirolimus|tacrolimus/sirolimus/prednisone
1192478|NCT00321906|E1|Reported Event|Azathioprine|(tacrolimus,azathioprine/prednisone)
1192479|NCT00321893|B3|Baseline|Total|Total of all reporting groups
1192480|NCT00321893|B2|Baseline|Arm II: Placebo|Inhaled placebo twice daily for 1 year
1192481|NCT00321893|B1|Baseline|Arm I: Budesonide|Inhaled Budesonide 800 ug twice daily for 1 year
1192482|NCT00321893|P2|Participant Flow|Arm II: Placebo|Inhaled placebo twice daily for 1 year
1192483|NCT00321893|P1|Participant Flow|Arm I: Budesonide|Inhaled Budesonide 800 micrograms (ug) twice daily for 1 year
1192484|NCT00321893|O2|Outcome|Arm II: Placebo|Inhaled placebo twice daily for 1 year
1192485|NCT00321893|O1|Outcome|Arm I: Budesonide|Inhaled Budesonide 800 ug twice daily for 1 year
1192486|NCT00321893|O2|Outcome|Arm II: Placebo|Inhaled placebo twice daily for 1 year
1192487|NCT00321893|O1|Outcome|Arm I: Budesonide|Inhaled Budesonide 800 ug twice daily for 1 year
1192488|NCT00321893|O2|Outcome|Arm II: Placebo|Inhaled placebo twice daily for 1 year
1192489|NCT00321893|O1|Outcome|Arm I: Budesonide|Inhaled Budesonide 800 ug twice daily for 1 year
1192490|NCT00321893|O2|Outcome|Arm II: Placebo|Inhaled placebo twice daily for 1 year
1192491|NCT00321893|O1|Outcome|Arm I: Budesonide|Inhaled Budesonide 800 ug twice daily for 1 year
1192492|NCT00321893|E2|Reported Event|Arm II: Placebo|Inhaled placebo twice daily for 1 year
1192493|NCT00321893|E1|Reported Event|Arm I: Budesonide|Inhaled Budesonide 800 ug twice daily for 1 year
1192494|NCT00321854|B3|Baseline|Total|Total of all reporting groups
1192495|NCT00321854|B2|Baseline|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192496|NCT00321854|B1|Baseline|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192497|NCT00321854|P2|Participant Flow|Delayed Pramipexole|Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study.
1192498|NCT00321854|P1|Participant Flow|Early Pramipexole|Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study.
1192499|NCT00321854|O2|Outcome|Delayed Pramipexole|Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study.
1192500|NCT00321854|O1|Outcome|Early Pramipexole|Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study.
1192501|NCT00321854|O2|Outcome|Delayed Pramipexole|Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study.
1192502|NCT00321854|O1|Outcome|Early Pramipexole|Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study.
1192503|NCT00321854|O2|Outcome|Delayed Pramipexole|Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study.
1192555|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1195589|NCT00313144|O3|Outcome|>6 Months to ≤12 Months|
1192504|NCT00321854|O1|Outcome|Early Pramipexole|Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study.
1192505|NCT00321854|O2|Outcome|Delayed Pramipexole|Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study.
1192506|NCT00321854|O1|Outcome|Early Pramipexole|Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study.
1192507|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192508|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192509|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192510|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192511|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192512|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192513|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192514|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192515|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192516|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192517|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192518|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192519|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192520|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192521|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192522|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192523|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192524|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192525|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192526|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192527|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192528|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192529|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192530|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192531|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192532|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192533|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192534|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192535|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192536|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192537|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192538|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192539|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192540|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192541|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192542|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192543|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192544|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192545|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192546|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192547|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192548|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192549|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192550|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192551|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192552|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192557|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192558|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192559|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192560|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192561|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192562|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192563|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192564|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192565|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192566|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192567|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192568|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192569|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192570|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192571|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192572|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192720|NCT00321737|P1|Participant Flow|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
1192573|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192574|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192575|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192576|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192577|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192578|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192579|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192580|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192581|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192582|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192583|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192584|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192585|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192586|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192587|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192588|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192589|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192590|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192591|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192592|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192593|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192594|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192595|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192596|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192597|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192598|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192599|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192600|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192601|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192602|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192603|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192604|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192605|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192606|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192607|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192608|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192609|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192611|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192612|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192613|NCT00321854|E2|Reported Event|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
1192614|NCT00321854|E1|Reported Event|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
1192615|NCT00321828|B1|Baseline|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
1192616|NCT00321828|P1|Participant Flow|Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
1192617|NCT00321828|O1|Outcome|Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
1192618|NCT00321828|E1|Reported Event|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
1192619|NCT00321789|B3|Baseline|Total|Total of all reporting groups
1192620|NCT00321789|B2|Baseline|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
1192621|NCT00321789|B1|Baseline|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
1192622|NCT00321789|P2|Participant Flow|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
1192623|NCT00321789|P1|Participant Flow|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
1192624|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
1192625|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
1192626|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
1192627|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
1192628|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
1192629|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
1192630|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
1192631|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
1192632|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
1192633|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
1192634|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
1192635|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
1192636|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
1192922|NCT00319982|O1|Outcome|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
1192637|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
1192638|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
1192639|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
1192640|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
1192641|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
1192642|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
1192721|NCT00321737|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
1192643|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
1192644|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
1192645|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
1192646|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
1192647|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
1192648|NCT00321789|E2|Reported Event|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
1192649|NCT00321789|E1|Reported Event|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
1192650|NCT00321763|B5|Baseline|Total|Total of all reporting groups
1192651|NCT00321763|B4|Baseline|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
1192652|NCT00321763|B3|Baseline|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192653|NCT00321763|B2|Baseline|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192654|NCT00321763|B1|Baseline|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192655|NCT00321763|P4|Participant Flow|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
1192656|NCT00321763|P3|Participant Flow|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192657|NCT00321763|P2|Participant Flow|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192658|NCT00321763|P1|Participant Flow|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192659|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
1192660|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
1192661|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192662|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192663|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192664|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
1192665|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
1192666|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1195129|NCT00314353|E1|Reported Event|Capecitabine, Oxaliplatin, Bevacizumab|
1192667|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192668|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192669|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
1192670|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
1192671|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192672|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192673|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192674|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
1192675|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
1192676|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192677|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192678|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192679|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
1192680|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
1192681|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192682|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192683|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192684|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
1192752|NCT00321711|P1|Participant Flow|Romiplostim (AMG 531) Placebo Plus Azacitidine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
1192685|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
1192686|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192687|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192688|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192689|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
1192690|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
1192691|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192692|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192693|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192694|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
1192695|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
1192696|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192697|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192698|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192699|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
1192700|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
1192701|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192702|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192703|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192704|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
1192705|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
1192706|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192707|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192708|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192709|NCT00321763|E5|Reported Event|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
1192753|NCT00321711|O5|Outcome|Romiplostim (AMG 531) 750 Mcg Plus Decitabine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
1192710|NCT00321763|E4|Reported Event|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
1192711|NCT00321763|E3|Reported Event|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192712|NCT00321763|E2|Reported Event|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192713|NCT00321763|E1|Reported Event|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1192714|NCT00321737|B4|Baseline|Total|Total of all reporting groups
1192715|NCT00321737|B3|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
1192716|NCT00321737|B2|Baseline|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
1192717|NCT00321737|B1|Baseline|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
1192718|NCT00321737|P3|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
1192719|NCT00321737|P2|Participant Flow|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
1192722|NCT00321737|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
1192723|NCT00321737|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
1192724|NCT00321737|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
1192725|NCT00321737|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
1192726|NCT00321737|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
1192727|NCT00321737|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
1192728|NCT00321737|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
1192729|NCT00321737|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
1192730|NCT00321737|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
1192731|NCT00321737|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
1192732|NCT00321737|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
1192733|NCT00321737|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
1192734|NCT00321737|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
1192735|NCT00321737|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
1192736|NCT00321737|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
1192737|NCT00321737|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
1192738|NCT00321737|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
1192739|NCT00321737|E3|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
1192740|NCT00321737|E2|Reported Event|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
1192741|NCT00321737|E1|Reported Event|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
1192742|NCT00321711|B6|Baseline|Total|Total of all reporting groups
1192743|NCT00321711|B5|Baseline|Romiplostim (AMG 531) 750 Mcg Plus Decitabine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
1192744|NCT00321711|B4|Baseline|Romiplostim (AMG 531) Placebo Plus Decitabine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
1192745|NCT00321711|B3|Baseline|Romiplostim (AMG 531) 750 Mcg Plus Azacitidine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
1192746|NCT00321711|B2|Baseline|Romiplostim (AMG 531) 500 Mcg Plus Azacitidine|500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
1192747|NCT00321711|B1|Baseline|Romiplostim (AMG 531) Placebo Plus Azacitidine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
1192748|NCT00321711|P5|Participant Flow|Romiplostim (AMG 531) 750 Mcg Plus Decitabine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
1192749|NCT00321711|P4|Participant Flow|Romiplostim (AMG 531) Placebo Plus Decitabine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
1192750|NCT00321711|P3|Participant Flow|Romiplostim (AMG 531) 750 Mcg Plus Azacitidine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
1192751|NCT00321711|P2|Participant Flow|Romiplostim (AMG 531) 500 Mcg Plus Azacitidine|500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
1192923|NCT00319982|O2|Outcome|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
1192754|NCT00321711|O4|Outcome|Romiplostim (AMG 531) Placebo Plus Decitabine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
1192755|NCT00321711|O3|Outcome|Romiplostim (AMG 531) 750 Mcg Plus Azacitidine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
1192756|NCT00321711|O2|Outcome|Romiplostim (AMG 531) 500 Mcg Plus Azacitidine|500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
1192757|NCT00321711|O1|Outcome|Romiplostim (AMG 531) Placebo Plus Azacitidine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
1192758|NCT00321711|O5|Outcome|Romiplostim (AMG 531) 750 Mcg Plus Decitabine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
1192759|NCT00321711|O4|Outcome|Romiplostim (AMG 531) Placebo Plus Decitabine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
1192760|NCT00321711|O3|Outcome|Romiplostim (AMG 531) 750 Mcg Plus Azacitidine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
1192761|NCT00321711|O2|Outcome|Romiplostim (AMG 531) 500 Mcg Plus Azacitidine|500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
1192762|NCT00321711|O1|Outcome|Romiplostim (AMG 531) Placebo Plus Azacitidine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
1193518|NCT00319592|B2|Baseline|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
1192763|NCT00321711|O5|Outcome|Romiplostim (AMG 531) 750 Mcg Plus Decitabine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
1192764|NCT00321711|O4|Outcome|Romiplostim (AMG 531) Placebo Plus Decitabine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
1192765|NCT00321711|O3|Outcome|Romiplostim (AMG 531) 750 Mcg Plus Azacitidine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
1192766|NCT00321711|O2|Outcome|Romiplostim (AMG 531) 500 Mcg Plus Azacitidine|500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
1192767|NCT00321711|O1|Outcome|Romiplostim (AMG 531) Placebo Plus Azacitidine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
1192768|NCT00321711|O5|Outcome|Romiplostim (AMG 531) 750 Mcg Plus Decitabine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
1192769|NCT00321711|O4|Outcome|Romiplostim (AMG 531) Placebo Plus Decitabine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
1192770|NCT00321711|O3|Outcome|Romiplostim (AMG 531) 750 Mcg Plus Azacitidine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
1192771|NCT00321711|O2|Outcome|Romiplostim (AMG 531) 500 Mcg Plus Azacitidine|500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
1192772|NCT00321711|O1|Outcome|Romiplostim (AMG 531) Placebo Plus Azacitidine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
1192773|NCT00321711|E5|Reported Event|Part B Romiplostim 750 µg|
1192774|NCT00321711|E4|Reported Event|Part B Placebo|
1192775|NCT00321711|E3|Reported Event|Part A Romiplostim 750 µg|
1192776|NCT00321711|E2|Reported Event|Part A Romiplostim 500 µg|
1192777|NCT00321711|E1|Reported Event|Part A Placebo|
1192778|NCT00321698|B6|Baseline|Total|Total of all reporting groups
1192779|NCT00321698|B5|Baseline|Phase II, MTD Dose|"Drug: docetaxel~Phase II with no phase I dose-limiting toxicities=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
1192780|NCT00321698|B4|Baseline|Phase I, Dose 3|"Drug: docetaxel~4 groups of men in phase I study.~Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
1192781|NCT00321698|B3|Baseline|Phase I, Dose 2|"Drug: docetaxel~4 groups of men in phase I study.~Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation;~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
1192782|NCT00321698|B2|Baseline|Phase I, Dose 1|"Drug: docetaxel~4 groups of men in phase I study.~Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation;~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
1192783|NCT00321698|B1|Baseline|Phase I, Radiation Only|"Drug: N/A~4 groups of men in phase I study.~Group 1=radiation only~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
1192784|NCT00321698|P5|Participant Flow|Phase II, MTD Dose|"MTD=Docetaxel IV over 30mins, 30mg/m2 weekly x 5 weeks starting on day one of radiation plus external beam radiation, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions).~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
1192885|NCT00321373|O1|Outcome|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1195590|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
1192785|NCT00321698|P4|Participant Flow|Phase I, Dose 3|"Group 4=IV over 30mins, 30mg/m2 weekly x 5 weeks starting on day one of radiation;~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)~Chemotherapy (Groups 2-4): Docetaxel IV over 30mins weekly x 5 weeks starting on day one of radiation. The maximum planned dose of 30 mg/m2 was reached without Dose-Limiting Toxicities."
1192786|NCT00321698|P3|Participant Flow|Phase I, Dose 2|"Group 3=IV over 30mins, 20mg/m2 weekly x 5 weeks starting on day one of radiation;~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)~Chemotherapy (Groups 2-4): Docetaxel IV over 30mins weekly x 5 weeks starting on day one of radiation. The maximum planned dose of 30 mg/m2 was reached without Dose-Limiting Toxicities."
1192787|NCT00321698|P2|Participant Flow|Phase I, Dose 1|"Group 2=IV over 30mins, 10mg/m2 weekly x 5 weeks starting on day one of radiation;~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)~Chemotherapy (Groups 2-4): Docetaxel IV over 30mins weekly x 5 weeks starting on day one of radiation. The maximum planned dose of 30 mg/m2 was reached without Dose-Limiting Toxicities."
1192788|NCT00321698|P1|Participant Flow|Phase I, Radiation Only|"Group 1=radiation only;~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
1192812|NCT00321672|B2|Baseline|Control Group, 60 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
1199148|NCT00301262|O1|Outcome|DB Viagra / OL Viagra|
1192789|NCT00321698|O1|Outcome|All Research Participants|"This Outcome Measure was assessed in aggregate, combining participants from both phases of the study, as per the planned protocol.~Phase I: Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.~Phase II: Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)."
1192790|NCT00321698|O1|Outcome|All Research Participants|"This Outcome Measure was assessed in aggregate, combining participants from both phases of the study, as per the planned protocol.~Phase I: Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.~Phase II: Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)."
1192791|NCT00321698|O2|Outcome|Phase II MTD Dose|"Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
1192792|NCT00321698|O1|Outcome|Phase I Dose 1-4|"Group 1=radiation only; Group 2=Docetaxel IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=Docetaxel IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
1192793|NCT00321698|O1|Outcome|All Research Participants|"This Outcome Measure was assessed in aggregate, combining participants from both phases of the study, as per the planned protocol.~Phase I: Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.~Phase II: Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)."
1192794|NCT00321698|O1|Outcome|Phase II MTD Dose|"Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
1192795|NCT00321698|O1|Outcome|Phase I Dose 1-4|"4 groups of men in phase I study.~Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation."
1192796|NCT00321698|E5|Reported Event|Phase II, MTD Dose|"Drug: docetaxel~Phase II with no phase I dose-limiting toxicities=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
1192797|NCT00321698|E4|Reported Event|Phase I, Dose 3|"Drug: docetaxel~4 groups of men in phase I study.~Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
1192798|NCT00321698|E3|Reported Event|Phase I, Dose 2|"Drug: docetaxel~4 groups of men in phase I study.~Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation;~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
1192799|NCT00321698|E2|Reported Event|Phase I, Dose 1|"Drug: docetaxel~4 groups of men in phase I study.~Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation;~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
1192800|NCT00321698|E1|Reported Event|Phase I, Radiation Only|"Drug: N/A~4 groups of men in phase I study.~Group 1=radiation only~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
1192886|NCT00321373|O3|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1193041|NCT00320671|P2|Participant Flow|Participants Will Take Risperidone Arm 2|-96 participants were randomized to to Arm 2
1192801|NCT00321685|B1|Baseline|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.~Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.~Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.~Postoperative chemotherapy: Approximately 4-8 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab."
1192813|NCT00321672|B1|Baseline|NGX-4010, 60 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 60 minutes.
1192814|NCT00321672|P4|Participant Flow|Control Group , 30 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
1192802|NCT00321685|P1|Participant Flow|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.~Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.~Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.~Postoperative chemotherapy: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab.~radiation therapy: Patients undergo 3-dimensional conformal radiation therapy once daily 5 days"
1192803|NCT00321685|O1|Outcome|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.~Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.~Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.~Postoperative chemotherapy: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab."
1192804|NCT00321685|O1|Outcome|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.~Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.~Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.~Postoperative chemotherapy: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab."
1192805|NCT00321685|O1|Outcome|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.~Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.~Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.~Postoperative chemotherapy: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab."
1192806|NCT00321685|O1|Outcome|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.~Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.~Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.~Postoperative chemotherapy: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab."
1192807|NCT00321685|O1|Outcome|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.~Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.~Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.~Postoperative chemotherapy: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab."
1192808|NCT00321685|E1|Reported Event|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.~Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.~Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.~Postoperative chemotherapy: Approximately 4-8 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab."
1192809|NCT00321672|B5|Baseline|Total|Total of all reporting groups
1192918|NCT00319982|B1|Baseline|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
1195591|NCT00313144|O1|Outcome|Baseline|
1192810|NCT00321672|B4|Baseline|Control Group , 30 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
1192811|NCT00321672|B3|Baseline|NGX-4010, 30 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 minutes.
1193303|NCT00320255|P1|Participant Flow|Cohort 1: Placebo|Participants received placebo tablets once daily
1192815|NCT00321672|P3|Participant Flow|NGX-4010, 30 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 minutes.
1192816|NCT00321672|P2|Participant Flow|Control Group, 60 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
1192817|NCT00321672|P1|Participant Flow|NGX-4010, 60 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 60 minutes.
1192818|NCT00321672|O6|Outcome|Control, Total|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 or 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
1192819|NCT00321672|O5|Outcome|NGX-4010 Total|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 or 60 minutes.
1192820|NCT00321672|O4|Outcome|Control Group , 30 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
1192821|NCT00321672|O3|Outcome|NGX-4010, 30 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 minutes.
1192822|NCT00321672|O2|Outcome|Control Group, 60 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
1192823|NCT00321672|O1|Outcome|NGX-4010, 60 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 60 minutes.
1192824|NCT00321672|O6|Outcome|Control, Total|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 or 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
1192825|NCT00321672|O5|Outcome|NGX-4010 Total|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 or 60 minutes.
1192826|NCT00321672|O4|Outcome|Control Group , 30 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
1192827|NCT00321672|O3|Outcome|NGX-4010, 30 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 minutes.
1192828|NCT00321672|O2|Outcome|Control Group, 60 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
1192829|NCT00321672|O1|Outcome|NGX-4010, 60 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 60 minutes.
1192919|NCT00319982|P2|Participant Flow|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
1192830|NCT00321672|O6|Outcome|Control, Total|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 or 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
1192831|NCT00321672|O5|Outcome|NGX-4010 Total|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 or 60 minutes.
1192832|NCT00321672|O4|Outcome|Control Group , 30 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
1192833|NCT00321672|O3|Outcome|NGX-4010, 30 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 minutes.
1192834|NCT00321672|O2|Outcome|Control Group, 60 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
1192835|NCT00321672|O1|Outcome|NGX-4010, 60 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 60 minutes.
1192836|NCT00321672|E6|Reported Event|Control, Total|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 or 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
1192837|NCT00321672|E5|Reported Event|NGX-4010 Total|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 or 60 minutes.
1192838|NCT00321672|E4|Reported Event|Control Group , 30 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
1192839|NCT00321672|E3|Reported Event|NGX-4010, 30 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 minutes.
1192840|NCT00321672|E2|Reported Event|Control Group, 60 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
1192841|NCT00321672|E1|Reported Event|NGX-4010, 60 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 60 minutes.
1192842|NCT00321646|B1|Baseline|Chemotherapy|"docetaxel and bevacizumab prior to prostatectomy~Docetaxel : Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.~Bevacizumab : Bevacizumab (marketed as Avastin, Genentech) is an antibody to all isoforms of vascular endothelial growth factor and is the first putative anti-angiogenic agent approved by the Food and Drug Administration (FDA) for the treatment of cancer.All subjects will be treated with intravenous docetaxel and bevacizumab for 5 cycles, followed by docetaxel alone for Cycle 6. Bevacizumab will be given first, at a starting dose of 15 mg/kg. Bevacizumab will be given once every 21 days in the infusion center."
1192843|NCT00321646|P1|Participant Flow|Chemotherapy|"docetaxel and bevacizumab prior to prostatectomy~Docetaxel : Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.~Bevacizumab : Bevacizumab (marketed as Avastin, Genentech) is an antibody to all isoforms of vascular endothelial growth factor and is the first putative anti-angiogenic agent approved by the Food and Drug Administration (FDA) for the treatment of cancer.All subjects will be treated with intravenous docetaxel and bevacizumab for 5 cycles, followed by docetaxel alone for Cycle 6. Bevacizumab will be given first, at a starting dose of 15 mg/kg. Bevacizumab will be given once every 21 days in the infusion center."
1192844|NCT00321646|O1|Outcome|Chemotherapy|"docetaxel and bevacizumab prior to prostatectomy~Docetaxel : Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.~Bevacizumab : Bevacizumab (marketed as Avastin, Genentech) is an antibody to all isoforms of vascular endothelial growth factor and is the first putative anti-angiogenic agent approved by the Food and Drug Administration (FDA) for the treatment of cancer.All subjects will be treated with intravenous docetaxel and bevacizumab for 5 cycles, followed by docetaxel alone for Cycle 6. Bevacizumab will be given first, at a starting dose of 15 mg/kg. Bevacizumab will be given once every 21 days in the infusion center."
1192845|NCT00321646|O1|Outcome|Chemotherapy|"docetaxel and bevacizumab prior to prostatectomy~Docetaxel : Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.~Bevacizumab : Bevacizumab (marketed as Avastin, Genentech) is an antibody to all isoforms of vascular endothelial growth factor and is the first putative anti-angiogenic agent approved by the Food and Drug Administration (FDA) for the treatment of cancer.All subjects will be treated with intravenous docetaxel and bevacizumab for 5 cycles, followed by docetaxel alone for Cycle 6. Bevacizumab will be given first, at a starting dose of 15 mg/kg. Bevacizumab will be given once every 21 days in the infusion center."
1192920|NCT00319982|P1|Participant Flow|I- Diltiazem (Active Arm)|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
1192846|NCT00321646|E1|Reported Event|Chemotherapy|"docetaxel and bevacizumab prior to prostatectomy~Docetaxel : Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.~Bevacizumab : Bevacizumab (marketed as Avastin, Genentech) is an antibody to all isoforms of vascular endothelial growth factor and is the first putative anti-angiogenic agent approved by the Food and Drug Administration (FDA) for the treatment of cancer.All subjects will be treated with intravenous docetaxel and bevacizumab for 5 cycles, followed by docetaxel alone for Cycle 6. Bevacizumab will be given first, at a starting dose of 15 mg/kg. Bevacizumab will be given once every 21 days in the infusion center."
1192847|NCT00321620|B3|Baseline|Total|Total of all reporting groups
1192848|NCT00321620|B2|Baseline|Denosumab|Denosumab 120 mg subcutaneously with an intravenous zoledronic acid placebo once every 4 weeks
1192849|NCT00321620|B1|Baseline|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
1192850|NCT00321620|P2|Participant Flow|Denosumab|Denosumab 120 mg subcutaneously with an intravenous zoledronic acid placebo once every 4 weeks
1192851|NCT00321620|P1|Participant Flow|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
1192852|NCT00321620|O2|Outcome|Denosumab|Denosumab 120 mg subcutaneously with an intravenous zoledronic acid placebo once every 4 weeks
1192853|NCT00321620|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
1192854|NCT00321620|O2|Outcome|Denosumab|Denosumab 120 mg subcutaneously with an intravenous zoledronic acid placebo once every 4 weeks
1192855|NCT00321620|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
1192856|NCT00321620|O2|Outcome|Denosumab|Denosumab 120 mg subcutaneously with an intravenous zoledronic acid placebo once every 4 weeks
1192857|NCT00321620|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
1192858|NCT00321620|E2|Reported Event|Denosumab 120 mg Q4W|
1192859|NCT00321620|E1|Reported Event|Zoledronic Acid 4 mg Q4W|
1192860|NCT00321464|B3|Baseline|Total|Total of all reporting groups
1192861|NCT00321464|B2|Baseline|Denosumab|Denomsumab 120 mg subcutaneously with intravenous zoledronic acid placebo once every 4 weeks
1192862|NCT00321464|B1|Baseline|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks
1192863|NCT00321464|P2|Participant Flow|Denosumab|Denomsumab 120 mg subcutaneously with intravenous zoledronic acid placebo once every 4 weeks
1192864|NCT00321464|P1|Participant Flow|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks
1192865|NCT00321464|O2|Outcome|Denosumab|Denomsumab 120 mg subcutaneously with intravenous zoledronic acid placebo once every 4 weeks
1192866|NCT00321464|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks
1192867|NCT00321464|O2|Outcome|Denosumab|Denomsumab 120 mg subcutaneously with intravenous zoledronic acid placebo once every 4 weeks
1192868|NCT00321464|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks
1192869|NCT00321464|O2|Outcome|Denosumab|Denomsumab 120 mg subcutaneously with intravenous zoledronic acid placebo once every 4 weeks
1192870|NCT00321464|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks
1192871|NCT00321464|E2|Reported Event|Denosumab 120 mg Q4W|
1192872|NCT00321464|E1|Reported Event|Zoledronic Acid 4 mg Q4W|
1192873|NCT00321373|B4|Baseline|Total|Total of all reporting groups
1192874|NCT00321373|B3|Baseline|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1192875|NCT00321373|B2|Baseline|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1192876|NCT00321373|B1|Baseline|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1192877|NCT00321373|P3|Participant Flow|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1192878|NCT00321373|P2|Participant Flow|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1192879|NCT00321373|P1|Participant Flow|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1192880|NCT00321373|O3|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1192881|NCT00321373|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1192882|NCT00321373|O1|Outcome|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1192883|NCT00321373|O3|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1192884|NCT00321373|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1192887|NCT00321373|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1192888|NCT00321373|O1|Outcome|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1192889|NCT00321373|O3|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1192890|NCT00321373|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1192891|NCT00321373|O1|Outcome|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1192892|NCT00321373|O3|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1192893|NCT00321373|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1192894|NCT00321373|O1|Outcome|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1192895|NCT00321373|O3|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1192896|NCT00321373|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1192897|NCT00321373|O1|Outcome|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1192898|NCT00321373|E3|Reported Event|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1192899|NCT00321373|E2|Reported Event|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1192900|NCT00321373|E1|Reported Event|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
1192901|NCT00321321|B1|Baseline|Sulfonylurea|
1192902|NCT00321321|P1|Participant Flow|Sulfonylurea|
1192903|NCT00321321|O1|Outcome|Sulfonylurea|
1192904|NCT00321321|E1|Reported Event|Sulfonylurea|Sulfonylurea-treated patients
1192905|NCT00321269|B3|Baseline|Total|Total of all reporting groups
1192906|NCT00321269|B2|Baseline|8-Week Phone-based Comorbid Illness Management|"Nursing intervention to treat Congestive Heart Failure and emotional coping~CHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping"
1192907|NCT00321269|B1|Baseline|8-week Phone Based Single Illness Management|"Standard nursing intervention to treat Congestive Heart Failure~Education & behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure"
1192908|NCT00321269|P2|Participant Flow|8-week Phone Based Comorbid Illness Management|"Nursing intervention to treat Congestive Heart Failure and emotional coping~CHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping"
1192909|NCT00321269|P1|Participant Flow|8-week Phone Based Single Illness Management|"Standard nursing intervention to treat Congestive Heart Failure~Education & behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure"
1192910|NCT00321269|O2|Outcome|8-Week Phone-Based Comorbid Illness Management|"Nursing intervention to treat Congestive Heart Failure and emotional coping~CHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping"
1192911|NCT00321269|O1|Outcome|8-Week Phone-Based Single Illness Management|"Standard nursing intervention to treat Congestive Heart Failure~Education & behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure"
1192912|NCT00321269|O2|Outcome|8-week Phone-based Comorbid Illness Management|"Nursing intervention to treat Congestive Heart Failure and emotional coping~CHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping"
1192913|NCT00321269|O1|Outcome|8-week Phone-based Single Illness Management|"Standard nursing intervention to treat Congestive Heart Failure~Education & behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure"
1192914|NCT00321269|E2|Reported Event|8-Week Phone Based Comorbid Illness Management|"Nursing intervention to treat Congestive Heart Failure and emotional coping~CHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping"
1192915|NCT00321269|E1|Reported Event|8-week Telephone Based Single Illness Management|"Standard nursing intervention to treat Congestive Heart Failure~Education & behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure"
1192916|NCT00319982|B3|Baseline|Total|Total of all reporting groups
1192917|NCT00319982|B2|Baseline|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
1192921|NCT00319982|O2|Outcome|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
1192924|NCT00319982|O1|Outcome|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
1192925|NCT00319982|O2|Outcome|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
1192926|NCT00319982|O1|Outcome|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
1192927|NCT00319982|O2|Outcome|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
1192928|NCT00319982|O1|Outcome|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
1192929|NCT00319982|O2|Outcome|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
1192930|NCT00319982|O1|Outcome|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
1192931|NCT00319982|O2|Outcome|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
1192932|NCT00319982|O1|Outcome|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
1192933|NCT00319982|O2|Outcome|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
1192934|NCT00319982|O1|Outcome|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
1192935|NCT00319982|E2|Reported Event|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
1192936|NCT00319982|E1|Reported Event|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
1192937|NCT00320801|B3|Baseline|Total|Total of all reporting groups
1192938|NCT00320801|B2|Baseline|Double-blind BTDS 20|Test treatment: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
1192939|NCT00320801|B1|Baseline|Double-blind BTDS 5|Reference treatment: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
1192940|NCT00320801|P4|Participant Flow|Extension Phase|Subjects received open-label buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear for up to 52 weeks.
1192941|NCT00320801|P3|Participant Flow|Double-blind BTDS 20|Test treatment: buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
1192942|NCT00320801|P2|Participant Flow|Double-blind BTDS 5|Reference treatment: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
1192943|NCT00320801|P1|Participant Flow|Run-in Period|(≤14 days). The run-in period was designed to select subjects who tolerated and responded to BTDS 20. Subjects were eligible to enter the double-blind phase if they tolerated BTDS 20 and achieved stable analgesia.
1192944|NCT00320801|O4|Outcome|Overall BTDS Exposure|Overall core and extension phase combined (run-in period, double-blind phase, and extension phase)
1192945|NCT00320801|O3|Outcome|Run-in Period|The run-in period was designed to determine tolerability of BTDS 20. Subjects were eligible to enter the double-blind phase if they tolerated BTDS 20 and achieved stable analgesia.
1192946|NCT00320801|O2|Outcome|Double-blind BTDS 20|Test treatment: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
1192947|NCT00320801|O1|Outcome|Double-blind BTDS 5|Reference treatment: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
1192948|NCT00320801|E4|Reported Event|Overall BTDS Exposure|Overall core and extension phase combined (run-in period, double-blind phase, and extension phase)
1192949|NCT00320801|E3|Reported Event|Open-label Run-in Period|The run-in period (14 days) was designed to identify subjects whose pain was controlled with and who tolerated BTDS 20. Open-label BTDS 10 or 20 mcg/h applied for 7-day wear to qualify for randomization into the double-blind phase.
1192950|NCT00320801|E2|Reported Event|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
1192951|NCT00320801|E1|Reported Event|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
1192952|NCT00320788|B6|Baseline|Total|Total of all reporting groups
1192953|NCT00320788|B5|Baseline|Aflibercept Injection 4.0mg q12|Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
1192954|NCT00320788|B4|Baseline|Aflibercept Injection 2.0mg q12|Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
1192955|NCT00320788|B3|Baseline|Aflibercept Injection 2.0mg q4|Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
1192956|NCT00320788|B2|Baseline|Aflibercept Injection 0.5mg q12|Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
1192957|NCT00320788|B1|Baseline|Aflibercept Injection 0.5mg q4|Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
1192958|NCT00320788|P5|Participant Flow|Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 4.0mg q12|Participants received 4.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
1192959|NCT00320788|P4|Participant Flow|Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q12|Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
1192960|NCT00320788|P3|Participant Flow|Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q4|Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12.
1192961|NCT00320788|P2|Participant Flow|Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q12|Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
1192962|NCT00320788|P1|Participant Flow|Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q4|Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12.
1192963|NCT00320788|O6|Outcome|Total|
1192964|NCT00320788|O5|Outcome|Aflibercept Injection 4.0mg q12|Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
1192965|NCT00320788|O4|Outcome|Aflibercept Injection 2.0mg q12|Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
1192966|NCT00320788|O3|Outcome|Aflibercept Injection 2.0mg q4|Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
1193433|NCT00320190|O1|Outcome|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
1192967|NCT00320788|O2|Outcome|Aflibercept Injection 0.5mg q12|Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
1192968|NCT00320788|O1|Outcome|Aflibercept Injection 0.5mg q4|Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
1192969|NCT00320788|O6|Outcome|Total|
1192970|NCT00320788|O5|Outcome|Aflibercept Injection 4.0mg q12|Participants received 4.0mg of aflibercept injection at 12 week intervals through Week 12.
1192971|NCT00320788|O4|Outcome|Aflibercept Injection 2.0mg q12|Participants received 2.0mg of aflibercept injection at 12 week intervals through Week 12.
1192972|NCT00320788|O3|Outcome|Aflibercept Injection 2.0mg q4|Participants received 2.0mg of aflibercept injection at 4 week intervals through Week 12.
1192973|NCT00320788|O2|Outcome|Aflibercept Injection 0.5mg q12|Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
1192974|NCT00320788|O1|Outcome|Aflibercept Injection 0.5mg q4|Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
1192975|NCT00320788|O6|Outcome|Total|
1192976|NCT00320788|O5|Outcome|Aflibercept Injection 4.0mg q12|Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
1192977|NCT00320788|O4|Outcome|Aflibercept Injection 2.0mg q12|Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
1192978|NCT00320788|O3|Outcome|Aflibercept Injection 2.0mg q4|Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
1192979|NCT00320788|O2|Outcome|Aflibercept Injection 0.5mg q12|Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
1192980|NCT00320788|O1|Outcome|Aflibercept Injection 0.5mg q4|Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
1192981|NCT00320788|O6|Outcome|Total|
1192982|NCT00320788|O5|Outcome|Aflibercept Injection 4.0mg q12|Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
1192983|NCT00320788|O4|Outcome|Aflibercept Injection 2.0mg q12|Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
1192984|NCT00320788|O3|Outcome|Aflibercept Injection 2.0mg q4|Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
1192985|NCT00320788|O2|Outcome|Aflibercept Injection 0.5mg q12|Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
1192986|NCT00320788|O1|Outcome|Aflibercept Injection 0.5mg q4|Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
1192987|NCT00320788|O6|Outcome|Total|
1192988|NCT00320788|O5|Outcome|Aflibercept Injection 4.0mg q12|Participants received 4.0mg of aflibercept injection at 12 week intervals through Week 12.
1192989|NCT00320788|O4|Outcome|Aflibercept Injection 2.0mg q12|Participants received 2.0mg of aflibercept injection at 12 week intervals through Week 12.
1192990|NCT00320788|O3|Outcome|Aflibercept Injection 2.0mg q4|Participants received 2.0mg of aflibercept injection at 4 week intervals through Week 12.
1192991|NCT00320788|O2|Outcome|Aflibercept Injection 0.5mg q12|Participants received 0.5mg of aflibercept injection at 12 week intervals through Week 12.
1192992|NCT00320788|O1|Outcome|Aflibercept Injection 0.5mg q4|Participants received 0.5mg of aflibercept injection at 4 week intervals through Week 12.
1192993|NCT00320788|O6|Outcome|Total|
1192994|NCT00320788|O5|Outcome|Aflibercept Injection 4.0mg q12|Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
1192995|NCT00320788|O4|Outcome|Aflibercept Injection 2.0mg q12|Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
1192996|NCT00320788|O3|Outcome|Aflibercept Injection 2.0mg q4|Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
1192997|NCT00320788|O2|Outcome|Aflibercept Injection 0.5mg q12|Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
1192998|NCT00320788|O1|Outcome|Aflibercept Injection 0.5mg q4|Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
1192999|NCT00320788|E5|Reported Event|Aflibercept Injection 4.0mg q12|Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
1193000|NCT00320788|E4|Reported Event|Aflibercept Injection 2.0mg q12|Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
1193001|NCT00320788|E3|Reported Event|Aflibercept Injection 2.0mg q4|Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
1193002|NCT00320788|E2|Reported Event|Aflibercept Injection 0.5mg q12|Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
1193003|NCT00320788|E1|Reported Event|Aflibercept Injection 0.5mg q4|Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
1193004|NCT00320749|B1|Baseline|Capecitabine, Gemcitabine and Docetaxel|Docetaxel i.v. over 30 min on days 1 and 8; Capecitabine p.o. in split doses bid on days 8-21, Gemcitabine i.v. over 75 min on days 8 and 15.
1193005|NCT00320749|P3|Participant Flow|Dose Level 3|Docetaxel at 36 mg/m2 on days 1 and 8, Gemcitabine at 750 mg/m2 (over 75 minutes) on days 8 and 15 and capecitabine at 625 mg/m2/12 hours on days 8-21
1193006|NCT00320749|P2|Participant Flow|Dose Level 2|Docetaxel at 30 mg/m2 on days 1 and 8, Gemcitabine at 750 mg/m2 (over 75 minutes) on days 8 and 15 and capecitabine at 625 mg/m2/12 hours on days 8-21
1193007|NCT00320749|P1|Participant Flow|Dose Level 1|Docetaxel at 30 mg/m2 on days 1 and 8, Gemcitabine at 750 mg/m2 (over 75 minutes) on days 8 and 15 and capecitabine at 500 mg/m2/12 hours on days 8-21
1193008|NCT00320749|O1|Outcome|Capecitabine, Docetaxel, Gemcitabine|Dose escalation study of mGTX using three dose levels (DL1-3). Patients received docetaxel on days 1 and 8, gemcitabine on days 8 and 15, and capecitabine on days 8 through 21. Gemcitabine fixed dose at 750 mg/m2 over 75 min, capecitabine twice daily and escalated from 500 to 650 mg/m2 at DL2 and docetaxel increased from 30 to 36 mg/m2 at DL3.
1193009|NCT00320749|O1|Outcome|Capecitabine, Docetaxel, Gemcitabine|Dose escalation study of mGTX using three dose levels (DL1-3). Patients received docetaxel on days 1 and 8, gemcitabine on days 8 and 15, and capecitabine on days 8 through 21. Gemcitabine fixed dose at 750 mg/m2 over 75 min, capecitabine twice daily and escalated from 500 to 650 mg/m2 at DL2 and docetaxel increased from 30 to 36 mg/m2 at DL3.
1193042|NCT00320671|P1|Participant Flow|Participants Will Take Aripiprazole Arm 1|-102 were allocated to Arm 1.
1193010|NCT00320749|O1|Outcome|Capecitabine, Docetaxel, Gemcitabine|"Dose escalation study of mGTX using three dose levels (DL1-3). Patients received docetaxel on days 1 and 8, gemcitabine on days 8 and 15, and capecitabine on days 8 through 21. Gemcitabine fixed dose at 750 mg/m2 over 75 min, capecitabine twice daily and escalated from 500 to 650 mg/m2 at DL2 and docetaxel increased from 30 to 36 mg/m2 at DL3.~Capecitabine: Will be give on days 8-21~Docetaxel: Will be given on days 1 and 8,~Gemcitabine: A fixed dose rate will be give on days 8 and 15."
1193011|NCT00320749|E1|Reported Event|Capecitabine, Docetaxel, Gemcitabine|Dose escalation study of mGTX using three dose levels (DL1-3). Patients received docetaxel on days 1 and 8, gemcitabine on days 8 and 15, and capcitabine on days 8 through 21. Gemcitabine fixed dose at 750 mg/m2 over 75 min, capecitabine twice daily and escalated from 500 to 650 mg/m2 at DL2 and docetaxel increased from 30 to 36 mg/m2 at DL3.
1193012|NCT00320710|B4|Baseline|Total|Total of all reporting groups
1193013|NCT00320710|B3|Baseline|Placebo / Zoledronic Acid|Participants randomized to this arm received placebo but the arm was later dropped and participants in this arm were later switched to the zoledronic acid q 4 weeks according to a study amendment.
1193014|NCT00320710|B2|Baseline|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
1193015|NCT00320710|B1|Baseline|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
1193444|NCT00320112|B3|Baseline|Total|Total of all reporting groups
1193016|NCT00320710|P3|Participant Flow|Placebo / Zoledronic Acid|Participants randomized to this arm received placebo but the arm was later dropped and participants in this arm were later switched to the zoledronic acid q 4 weeks according to a study amendment.
1193017|NCT00320710|P2|Participant Flow|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
1193018|NCT00320710|P1|Participant Flow|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
1193019|NCT00320710|O2|Outcome|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
1193020|NCT00320710|O1|Outcome|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
1193021|NCT00320710|O2|Outcome|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
1193022|NCT00320710|O1|Outcome|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
1193023|NCT00320710|O2|Outcome|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
1193024|NCT00320710|O1|Outcome|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
1193025|NCT00320710|O2|Outcome|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
1193026|NCT00320710|O1|Outcome|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
1193027|NCT00320710|O2|Outcome|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
1193028|NCT00320710|O1|Outcome|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
1193029|NCT00320710|O2|Outcome|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
1193030|NCT00320710|O1|Outcome|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
1193031|NCT00320710|O2|Outcome|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
1193032|NCT00320710|O1|Outcome|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
1193033|NCT00320710|O2|Outcome|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
1193034|NCT00320710|O1|Outcome|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
1193035|NCT00320710|E3|Reported Event|Placebo / Zoledronic Acid|Participants randomized to this arm received placebo but the arm was later dropped and participants in this arm were later switched to the zoledronic acid q 4 weeks according to a study amendment.
1193036|NCT00320710|E2|Reported Event|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
1193037|NCT00320710|E1|Reported Event|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
1193038|NCT00320671|B3|Baseline|Total|Total of all reporting groups
1193039|NCT00320671|B2|Baseline|Participants Will Take Risperidone|"Participants will take risperidone~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day in capsule form. The dose of risperidone will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks, then every 2 weeks until the 12th week, and then monthly until the study end."
1193040|NCT00320671|B1|Baseline|Participants Will Take Aripiprazole|"Participants will take aripiprazole~Aripiprazole: The dosage for aripiprazole will be 5 mg to 30 mg per day in capsule form. The dose of aripiprazole will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks and then every 2 weeks until the 12th week and then monthly until study end."
1193043|NCT00320671|O2|Outcome|Percentage of Participants That Reposonded to Risperidone|Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day in capsule form. The dose of risperidone will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks, then every 2 weeks until the 12th week, and then monthly until the study end.
1193044|NCT00320671|O1|Outcome|Percentage of Participants That Reposonded to Aripiprazole|Aripiprazole: The dosage for aripiprazole will be 5 mg to 30 mg per day in capsule form. The dose of aripiprazole will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks and then every 2 weeks until the 12th week and then monthly until study end.
1193045|NCT00320671|E2|Reported Event|Participants Will Take Risperidone|Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day in capsule form. The dose of risperidone will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks, then every 2 weeks until the 12th week, and then monthly until the study end.
1193046|NCT00320671|E1|Reported Event|Participants Will Take Aripiprazole|Aripiprazole: The dosage for aripiprazole will be 5 mg to 30 mg per day in capsule form. The dose of aripiprazole will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks and then every 2 weeks until the 12th week and then monthly until study end.
1193047|NCT00320606|B1|Baseline|Immunosuppression Withdrawal Arm|Subjects will be tapered off of their single immunosuppression drug (cyclosporine or tacrolimus)
1193048|NCT00320606|P1|Participant Flow|Immunosuppression Withdrawal Arm|Subjects will be tapered off of their single immunosuppression drug (cyclosporine or tacrolimus)
1193049|NCT00320606|O1|Outcome|Immunosuppression Withdrawal Arm|Subjects will be tapered off of their single immunosuppression drug (cyclosporine or tacrolimus)
1193050|NCT00320606|E1|Reported Event|Immunosuppression Withdrawal Arm|Subjects will be tapered off of their single immunosuppression drug (cyclosporine or tacrolimus)
1193051|NCT00320593|B3|Baseline|Total|Total of all reporting groups
1193052|NCT00320593|B2|Baseline|Single Vision Lenses (SVLs)|Standard single vision lenses
1193053|NCT00320593|B1|Baseline|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
1193054|NCT00320593|P2|Participant Flow|Single Vision Lenses (SVLs)|Standard single vision lenses
1193055|NCT00320593|P1|Participant Flow|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
1193056|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
1193057|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
1193058|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
1193059|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
1193060|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
1193061|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
1193062|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
1193063|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
1193064|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
1193065|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
1193066|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
1193067|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
1193068|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
1193069|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
1193070|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
1193071|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
1193072|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
1193073|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
1193074|NCT00320593|E2|Reported Event|Single Vision Lenses (SVLs)|Standard single vision lenses
1193075|NCT00320593|E1|Reported Event|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
1193076|NCT00320541|B3|Baseline|Total|Total of all reporting groups
1193077|NCT00320541|B2|Baseline|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
1193078|NCT00320541|B1|Baseline|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
1193079|NCT00320541|P2|Participant Flow|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
1193080|NCT00320541|P1|Participant Flow|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
1193081|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
1193434|NCT00320190|O2|Outcome|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
1193082|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
1193083|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
1193084|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
1193085|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
1193086|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
1194498|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
1193087|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
1193088|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
1193089|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
1193090|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
1193091|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
1193092|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
1193093|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
1193094|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
1193095|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
1193096|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
1193097|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
1193098|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
1193099|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
1193100|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
1193101|NCT00320541|E2|Reported Event|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
1193102|NCT00320541|E1|Reported Event|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
1193103|NCT00320528|B4|Baseline|Total|Total of all reporting groups
1193104|NCT00320528|B3|Baseline|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193219|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
1193105|NCT00320528|B2|Baseline|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193106|NCT00320528|B1|Baseline|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193107|NCT00320528|P3|Participant Flow|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193108|NCT00320528|P2|Participant Flow|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193109|NCT00320528|P1|Participant Flow|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193110|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193111|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193112|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193113|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193114|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193115|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193116|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193117|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193118|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193119|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193120|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193121|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193122|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193123|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193124|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193125|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193126|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193127|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193128|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193129|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193130|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193131|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193132|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193133|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193134|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193135|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193136|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193137|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193138|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193139|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193140|NCT00320528|E3|Reported Event|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193141|NCT00320528|E2|Reported Event|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193142|NCT00320528|E1|Reported Event|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
1193143|NCT00320515|B1|Baseline|Pemetrexed + Cisplatin|Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
1193144|NCT00320515|P1|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
1193145|NCT00320515|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
1193146|NCT00320515|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
1193147|NCT00320515|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
1193148|NCT00320515|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
1193149|NCT00320515|E1|Reported Event|Pemetrexed + Cisplatin|Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
1193150|NCT00320489|B3|Baseline|Total|Total of all reporting groups
1193151|NCT00320489|B2|Baseline|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
1193152|NCT00320489|B1|Baseline|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
1193153|NCT00320489|P2|Participant Flow|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
1193220|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
1193154|NCT00320489|P1|Participant Flow|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
1193155|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
1193156|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
1193157|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
1193158|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
1193159|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
1193445|NCT00320112|B2|Baseline|Nurse Case Management|participants were randomized to receive usual care with an initial educational session to review lab results and discuss any questions related to educational handouts
1193160|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
1193161|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
1193162|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
1193163|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
1193164|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
1193165|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
1193166|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
1193167|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
1193168|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
1193169|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
1193170|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
1193171|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
1193172|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
1193173|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
1193174|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
1193175|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
1193176|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
1193177|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
1193178|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
1193179|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
1193180|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
1193181|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
1193182|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
1193183|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
1193221|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
1195592|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
1193184|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
1193185|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
1193186|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
1193187|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
1193188|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
1193189|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
1193190|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
1193191|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
1193192|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
1193193|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
1193194|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
1193195|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
1193196|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
1193197|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
1193198|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
1193199|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
1193200|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
1193201|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
1193202|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
1193203|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
1193204|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
1193205|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
1193206|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
1193207|NCT00320489|E2|Reported Event|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
1193208|NCT00320489|E1|Reported Event|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
1193209|NCT00320411|B1|Baseline|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
1193210|NCT00320411|P1|Participant Flow|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
1193211|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
1193212|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
1193213|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
1193214|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
1193215|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
1193216|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
1193217|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
1193218|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
1195593|NCT00313144|O1|Outcome|Baseline|
1193222|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
1193223|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
1193224|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
1193225|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
1193226|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
1193227|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
1193228|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
1193229|NCT00320411|E1|Reported Event|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
1193230|NCT00320385|B3|Baseline|Total|Total of all reporting groups
1193231|NCT00320385|B2|Baseline|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
1193510|NCT00319644|P1|Participant Flow|Tracheal Aspirates|No intervention. Standard of care in ICU.
1199149|NCT00301262|O2|Outcome|DB Placebo/ OL Viagra|
1193232|NCT00320385|B1|Baseline|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
1193233|NCT00320385|P2|Participant Flow|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
1193234|NCT00320385|P1|Participant Flow|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
1193235|NCT00320385|O2|Outcome|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
1193236|NCT00320385|O1|Outcome|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
1193237|NCT00320385|O2|Outcome|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
1193238|NCT00320385|O1|Outcome|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
1193239|NCT00320385|O2|Outcome|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
1193240|NCT00320385|O1|Outcome|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
1193241|NCT00320385|O2|Outcome|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
1193242|NCT00320385|O1|Outcome|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
1193243|NCT00320385|O2|Outcome|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
1193244|NCT00320385|O1|Outcome|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
1193245|NCT00320385|O2|Outcome|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
1193246|NCT00320385|O1|Outcome|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
1193247|NCT00320385|O2|Outcome|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
1193248|NCT00320385|O1|Outcome|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
1193249|NCT00320385|O2|Outcome|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
1193250|NCT00320385|O1|Outcome|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
1193251|NCT00320385|E2|Reported Event|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
1193252|NCT00320385|E1|Reported Event|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
1193253|NCT00320372|B4|Baseline|Total|Total of all reporting groups
1193254|NCT00320372|B3|Baseline|Treatment as Usual (TAU)|Non-VNS Patients - Treatment-resistant depression patients not receiving VNS Therapy. Subjects that entered the TRD Registry without previous VNS Therapy treatment and selected the TAU study arm.
1193296|NCT00320255|B2|Baseline|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
1193297|NCT00320255|B1|Baseline|Cohort 1: Placebo|Participants received placebo tablets once daily
1195594|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
1193255|NCT00320372|B2|Baseline|VNS Therapy D-21 Rollover|Subjects that entered the TRD Registry, having previously participated in the D-21 study and still being treated with VNS Therapy treatment were included within the VNS Therapy group. Based on the duration from initial implant to enrollment date, the D-21 rollover patients entered at the appropriate D-23 follow-up interval (i.e., patient enrolls at 24 months post implant for their first D-23 follow up visit. This 24 month visit corresponds to the 24 month follow up in the TRD Registry). Starting with the first TRD Registry visit, the D-21 long-term patients were to follow the same data collection schedule as other Original VNS and TAU Registry patients.
1193256|NCT00320372|B1|Baseline|VNS Therapy D-23 Original|Subjects that entered the TRD Registry without previous VNS Therapy treatment and selected the VNS Therapy study arm.
1193257|NCT00320372|P2|Participant Flow|Treatment as Usual (TAU)|Disposition of study patients from baseline to the end of the study. The TAU arm were subjects that entered the TRD Registry without previous VNS Therapy treatment and selected the TAU study arm.
1193511|NCT00319644|O2|Outcome|Tracheal Aspirates|No intervention. Standard of care in ICU. the aspirates were sent for micro culture.
1193258|NCT00320372|P1|Participant Flow|VNS Therapy|Disposition of study patients from baseline to the end of the study. The VNS Therapy arm, was comprised of D-23 Original patients (Patients that entered the TRD Registry without previous VNS Therapy treatment and selected the VNS Therapy study arm) and D-21 Rollover patients (Patients that entered the TRD Registry, having previously participated in the D-21 study-NCT00305565 and still being treated with VNS Therapy).
1193259|NCT00320372|O1|Outcome|ITT Population|VNS Therapy and Treatment as Usual (TAU)
1193260|NCT00320372|O1|Outcome|ITT Population|VNS Therapy and Treatment as Usual (TAU)
1193261|NCT00320372|O1|Outcome|ITT Population|VNS Therapy and Treatment as Usual (TAU)
1193262|NCT00320372|O2|Outcome|Treatment As Usual (TAU)|Change from Baseline Score
1193263|NCT00320372|O1|Outcome|VNS Therapy|Change from Baseline Score
1193264|NCT00320372|O1|Outcome|ITT Population|VNS Therapy and Treatment as Usual (TAU)
1193265|NCT00320372|O2|Outcome|Treatment as Usual (TAU)|Non-VNS Patients - Treatment-resistant depression patients not receiving VNS Therapy
1193266|NCT00320372|O1|Outcome|VNS Therapy|VNS Patients - Treatment-resistant depression patients treated with VNS Therapy
1193267|NCT00320372|O2|Outcome|Treatment as Usual (TAU)|Non-VNS Patients - Treatment-resistant depression patients not receiving VNS Therapy
1193268|NCT00320372|O1|Outcome|VNS Therapy|VNS Patients - Treatment-resistant depression patients treated with VNS Therapy
1193269|NCT00320372|O2|Outcome|Treatment as Usual (TAU)|Non-VNS Patients - Treatment-resistant depression patients not receiving VNS Therapy
1193270|NCT00320372|O1|Outcome|VNS Therapy|VNS Patients - Treatment-resistant depression patients treated with VNS Therapy
1193271|NCT00320372|O2|Outcome|Treatment as Usual (TAU)|Non-VNS Patients - Treatment-resistant depression patients not receiving VNS Therapy
1193272|NCT00320372|O1|Outcome|VNS Therapy|VNS Patients - Treatment-resistant depression patients treated with VNS Therapy
1193273|NCT00320372|O2|Outcome|Treatment as Usual (TAU)|Non-VNS Patients - Treatment-resistant depression patients not receiving VNS Therapy
1193274|NCT00320372|O1|Outcome|VNS Therapy|VNS Patients - Treatment-resistant depression patients treated with VNS Therapy
1193275|NCT00320372|O2|Outcome|Treatment As Usual (TAU)|MADRS % Remitters (Percentage of Subjects in Remission)
1193276|NCT00320372|O1|Outcome|VNS Therapy|MADRS % Remitters (Percentage of Subjects in Remission)
1193277|NCT00320372|O2|Outcome|Treatment As Usual (TAU)|Time until recurrence based on the MADRS
1193278|NCT00320372|O1|Outcome|VNS Therapy|Time until recurrence based on the MADRS
1193279|NCT00320372|O2|Outcome|Treatment As Usual (TAU)|MADRS % Responders (Percentage of Responders)
1193280|NCT00320372|O1|Outcome|VNS Therapy|MADRS % Responders (Percentage of Responders)
1193281|NCT00320372|E1|Reported Event|Safety Events|N/A (not collected)
1193282|NCT00320281|B3|Baseline|Total|Total of all reporting groups
1193283|NCT00320281|B2|Baseline|Group 2-saline Group|Group 2 is the control group and received injections of saline instead of the saline plus botox A injections that the treatment group received
1193284|NCT00320281|B1|Baseline|Group 1-Botox A Group|This group received the active drug, botox a injections.
1193285|NCT00320281|P2|Participant Flow|Group 2-saline Group|Group 2 is the control group and received injections of saline instead of the saline plus botox A injections that the treatment group received
1193286|NCT00320281|P1|Participant Flow|Group 1-Botox A Group|This group received the active drug, botox a injections.
1193287|NCT00320281|O2|Outcome|Group 2-saline Group|Those randomized to this treatment group received injections based on treatment plan devised by study PI and study physical therapist. 25 cc of saline were used for these injections. Multiple injections may have occured during a single clinic visit based on pain/stiffness upon assesment by the study treatment team.
1193288|NCT00320281|O1|Outcome|Group 1-Botox A Group|Those randomized to this treatment group received injections based on treatment plan designed by PI and study physical therapist. Botulism toxin A was diluted in 25 cc of saline for the injections. Multiple injections may have occured during a single clinic visit based on pain/stiffness upon assesment by the study treatment team.
1193289|NCT00320281|E2|Reported Event|Group 2-saline Group|Group 2 is the control group and received injections of saline instead of the saline plus botox A injections that the treatment group received
1193290|NCT00320281|E1|Reported Event|Group 1-Botox A Group|This group received the active drug, botox a injections.
1193291|NCT00320255|B7|Baseline|Total|Total of all reporting groups
1193292|NCT00320255|B6|Baseline|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
1193293|NCT00320255|B5|Baseline|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
1193294|NCT00320255|B4|Baseline|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
1193295|NCT00320255|B3|Baseline|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
1195595|NCT00313144|O1|Outcome|Baseline|
1193298|NCT00320255|P6|Participant Flow|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
1193299|NCT00320255|P5|Participant Flow|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
1193300|NCT00320255|P4|Participant Flow|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
1193301|NCT00320255|P3|Participant Flow|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
1193302|NCT00320255|P2|Participant Flow|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
1193304|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
1193305|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
1193306|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
1193307|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
1193308|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
1193309|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
1193310|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
1193311|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
1193312|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
1193313|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
1193314|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
1193315|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
1193316|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
1193317|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
1193318|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
1193319|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
1193320|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
1193321|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
1193322|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
1193323|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
1193324|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
1193325|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
1193326|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
1193327|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
1193328|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
1193329|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
1193330|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
1193331|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
1193332|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
1193333|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
1193428|NCT00320190|O2|Outcome|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
1193334|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
1193335|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
1193336|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
1193337|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
1193338|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
1193339|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
1193340|NCT00320255|O6|Outcome|Cohort 2: Apixiban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
1193341|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
1193342|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
1193343|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
1193344|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
1193345|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
1193346|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
1193347|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
1193348|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
1193349|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
1193350|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
1193351|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
1193352|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
1193353|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
1193354|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
1193355|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
1193356|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
1193357|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
1193358|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
1193359|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
1193360|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
1193361|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
1193362|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
1193363|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
1193364|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
1193365|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
1193366|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
1193367|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
1193368|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
1193369|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
1193429|NCT00320190|O1|Outcome|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
1193370|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
1193371|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
1193372|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
1193373|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
1193374|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
1193375|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
1193376|NCT00320255|E6|Reported Event|Cohort : Apixaban, 5 mg|:Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
1193377|NCT00320255|E5|Reported Event|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
1193378|NCT00320255|E4|Reported Event|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
1193379|NCT00320255|E3|Reported Event|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
1193380|NCT00320255|E2|Reported Event|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
1193381|NCT00320255|E1|Reported Event|Cohort 1: Placebo|Participants received placebo tablets once daily
1193382|NCT00320216|B6|Baseline|Total|Total of all reporting groups
1193383|NCT00320216|B5|Baseline|Group V: Ustekinumab 90 mg Weekly for 4 Weeks|Participants received ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
1193384|NCT00320216|B4|Baseline|Group IV: Ustekinumab 45 mg Weekly for 4 Weeks|Participants received ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
1193385|NCT00320216|B3|Baseline|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
1193386|NCT00320216|B2|Baseline|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
1193387|NCT00320216|B1|Baseline|Group I: Placebo|Participants received placebo at Weeks 0, 1, 2 and 3. At week 16, all participants received placebo regardless of Physician's Global Assessment (PGA). At week 20, all participants received a single dose of ustekinumab 90 mg.
1193388|NCT00320216|P5|Participant Flow|Ustekinumab 90 mg Weekly for 4 Weeks (CP)|Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA >= 3 received ustekinumab 90 mg.
1193389|NCT00320216|P4|Participant Flow|Ustekinumab 45 mg Weekly for 4 Weeks (CP)|Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA >= 3 received ustekinumab 45 mg.
1193390|NCT00320216|P3|Participant Flow|Ustekinumab 90 mg (CP)|Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0. At week 16, participants with PGA >= 3 received ustekinumab 90 mg.
1193391|NCT00320216|P2|Participant Flow|Ustekinumab 45 mg (CP)|Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0. At week 16, participants with PGA >= 3 received ustekinumab 45 mg.
1193392|NCT00320216|P1|Participant Flow|Placebo (CP)|Controlled period (Week 0-20) - receiving placebo at Weeks 0, 1, 2, 3 and 16.
1193393|NCT00320216|O5|Outcome|Group V: Ustekinumab 90 mg Weekly for 4 Weeks|Participants received ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
1193394|NCT00320216|O4|Outcome|Group IV: Ustekinumab 45 mg Weekly for 4 Weeks|Participants received ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
1193395|NCT00320216|O3|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
1193396|NCT00320216|O2|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
1193397|NCT00320216|O1|Outcome|Group I: Placebo|Participants received placebo at Weeks 0, 1, 2 and 3. At week 16, all participants received placebo regardless of Physician's Global Assessment (PGA). At week 20, all participants received a single dose of ustekinumab 90 mg.
1193398|NCT00320216|O5|Outcome|Group V: Ustekinumab 90 mg Weekly for 4 Weeks|Participants received ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
1193430|NCT00320190|O2|Outcome|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
1195596|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
1193399|NCT00320216|O4|Outcome|Group IV: Ustekinumab 45 mg Weekly for 4 Weeks|Participants received ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
1193400|NCT00320216|O3|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
1193401|NCT00320216|O2|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
1193512|NCT00319644|O1|Outcome|Mini-BAL|BAL for quantitative culture as TA group.
1199150|NCT00301262|O1|Outcome|DB Viagra / OL Viagra|
1193402|NCT00320216|O1|Outcome|Group I: Placebo|Participants received placebo at Weeks 0, 1, 2 and 3. At week 16, all participants received placebo regardless of Physician's Global Assessment (PGA). At week 20, all participants received a single dose of ustekinumab 90 mg.
1193403|NCT00320216|O5|Outcome|Group V: Ustekinumab 90 mg Weekly for 4 Weeks|Participants received ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
1193404|NCT00320216|O4|Outcome|Group IV: Ustekinumab 45 mg Weekly for 4 Weeks|Participants received ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
1193405|NCT00320216|O3|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
1193406|NCT00320216|O2|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
1193407|NCT00320216|O1|Outcome|Group I: Placebo|Participants received placebo at Weeks 0, 1, 2 and 3. At week 16, all participants received placebo regardless of Physician's Global Assessment (PGA). At week 20, all participants received a single dose of ustekinumab 90 mg.
1193408|NCT00320216|O5|Outcome|Group V: Ustekinumab 90 mg Weekly for 4 Weeks|Participants received ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
1193409|NCT00320216|O4|Outcome|Group IV: Ustekinumab 45 mg Weekly for 4 Weeks|Participants received ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
1193410|NCT00320216|O3|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
1193411|NCT00320216|O2|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
1193412|NCT00320216|O1|Outcome|Group I: Placebo|Participants received placebo at Weeks 0, 1, 2 and 3. At week 16, all participants received placebo regardless of Physician's Global Assessment (PGA). At week 20, all participants received a single dose of ustekinumab 90 mg.
1193413|NCT00320216|E10|Reported Event|Ustekinumab 90 mg Weekly for 4 Weeks (After CP)|After Controlled period (Week 20-36) - receiving ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At Week 16, participants with PGA >= 3 received ustekinumab 90 mg.
1193414|NCT00320216|E9|Reported Event|Ustekinumab 45 mg Weekly for 4 Weeks (After CP)|After Controlled period (Week 20-36) - receiving ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At Week 16, participants with PGA >= 3 received ustekinumab 45 mg.
1193415|NCT00320216|E8|Reported Event|Ustekinumab 90 mg (After CP)|After Controlled period (Week 20-36) - receiving ustekinumab 90 mg at Week 0. At Week 16, participants with PGA >= 3 received ustekinumab 90 mg.
1193416|NCT00320216|E7|Reported Event|Ustekinumab 45 mg (After CP)|After Controlled period (Week 20-36) - receiving ustekinumab 45 mg at Week 0. At Week 16, participants with PGA >= 3 received ustekinumab 45 mg.
1193417|NCT00320216|E6|Reported Event|Placebo -> Ustekinumab 90 mg (After CP)|After Controlled period (Week 20-36) - receiving placebo at Weeks 0, 1, 2, 3 and 16 -> receiving ustekinumab 90 mg at Week 20.
1193418|NCT00320216|E5|Reported Event|Ustekinumab 90 mg Weekly for 4 Weeks (CP)|Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA >= 3 received ustekinumab 90 mg.
1193419|NCT00320216|E4|Reported Event|Ustekinumab 45 mg Weekly for 4 Weeks (CP)|Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA >= 3 received ustekinumab 45 mg.
1193420|NCT00320216|E3|Reported Event|Ustekinumab 90 mg (CP)|Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0. At week 16, participants with PGA >= 3 received ustekinumab 90 mg.
1193421|NCT00320216|E2|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0. At week 16, participants with PGA >= 3 received ustekinumab 45 mg.
1193422|NCT00320216|E1|Reported Event|Placebo (CP)|Controlled period (Week 0-20) - receiving placebo at Weeks 0, 1, 2, 3 and 16.
1193423|NCT00320190|B3|Baseline|Total|Total of all reporting groups
1193424|NCT00320190|B2|Baseline|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
1193425|NCT00320190|B1|Baseline|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
1193426|NCT00320190|P2|Participant Flow|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
1193427|NCT00320190|P1|Participant Flow|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
1195597|NCT00313144|O1|Outcome|Baseline|
1193435|NCT00320190|O1|Outcome|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
1193436|NCT00320190|O2|Outcome|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
1193437|NCT00320190|O1|Outcome|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
1193438|NCT00320190|O2|Outcome|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
1193439|NCT00320190|O1|Outcome|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
1193440|NCT00320190|O2|Outcome|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
1193441|NCT00320190|O1|Outcome|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
1193442|NCT00320190|E2|Reported Event|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily
1193443|NCT00320190|E1|Reported Event|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
1193446|NCT00320112|B1|Baseline|Receiprocal Peer Support|"participants in the intervention arm are paired with a peer~Peer-support telephone calls: peers are paired during the group visit and are encouraged to speak with their partner at least once a week for the 6 month duration of the study.~group outpatient counseling visits: participants are given the option to attend 3 optional group visits with other participants and case managers. this gives them the opportunity to ask any diabetes related questions of nurses or other participants who have diabetes."
1193447|NCT00320112|P2|Participant Flow|Nurse Case Management|participants were randomized to receive usual care with an initial educational session to review lab results and discuss any questions related to educational handouts. particpants were also provided information about nurse case managements services and encouraged to use the service regularly.
1193448|NCT00320112|P1|Participant Flow|Reciprocal Diabetes Peer Support Program (RPS)|"participants in the intervention arm are paired with a peer~Peer-support telephone calls: peers are paired during the group visit and are encouraged to speak with their partner at least once a week for the 6 month duration of the study.~group outpatient counseling visits: participants are given the option to attend 3 optional group visits with other participants and case managers. this gives them the opportunity to ask any diabetes related questions of nurses or other participants who have diabetes."
1193449|NCT00320112|O2|Outcome|Nurse Case Management Grouop|patients were provided an educational session and discussed nurse case management services. participants were encouraged to meet wit their case manager regularly.
1193450|NCT00320112|O1|Outcome|Reciprocal Peer Support Group|patients were age-matched and assigned to a peer. they were asked to make weekly calls using a telephone support system to check in and discuss their diabetes
1193451|NCT00320112|O2|Outcome|Nurse Case Management Group|participants in the nurse case management group receive initial educational session on diabetes and information bout case management services. they are encouraged to contact their nurse case manager regularly.
1193452|NCT00320112|O1|Outcome|Reciprocal Peer Support Group|participants are age-matched with a peer and asked to talk with each other weekly using a telephone support sytem
1193453|NCT00320112|O2|Outcome|Change in Systsolic at 6 Months for Nurse Mgt Group|change in systolic blood pressure from baseline to six months in the nurse case management group
1193454|NCT00320112|O1|Outcome|Change in Systolic BP at 6 Months for Peer Support Group|change in systolic blood pressure from baseline to six months among participants in the peer support group
1193455|NCT00320112|O2|Outcome|Nurse Case Management Group|Nurse Case Management group was offered an educational session with nurse case managers on diabetes and informed of case management services. they were encouraged to utilize this service regularly.
1193456|NCT00320112|O1|Outcome|Reciprocal Peer Support Group|"participants in the intervention arm are paired with a peer~Peer-support telephone calls: peers are paired during the group visit and are encouraged to speak with their partner at least once a week for the 6 month duration of the study.~group outpatient counseling visits: participants are given the option to attend 3 optional group visits with other participants and case managers. this gives them the opportunity to ask any diabetes related questions of nurses or other participants who have diabetes."
1193457|NCT00320112|E2|Reported Event|Nurse Case Management Intervention|participants were randomized to receive usual care with an initial educational session to review lab results and discuss any questions related to educational handouts
1193458|NCT00320112|E1|Reported Event|Reciprocal Peer Support Intervention|"participants in the intervention arm are paired with a peer~Peer-support telephone calls: peers are paired during the group visit and are encouraged to speak with their partner at least once a week for the 6 month duration of the study.~group outpatient counseling visits: participants are given the option to attend 3 optional group visits with other participants and case managers. this gives them the opportunity to ask any diabetes related questions of nurses or other participants who have diabetes."
1193459|NCT00319748|B1|Baseline|Patients Treated With 852A Study Drug|Patients that received at least one dose of study treatment with 852A (0.6 mg/m^2 to 1.2 mg/m^2 dose, 2 times/week for 12 weeks).
1193460|NCT00319748|P1|Participant Flow|Patients Treated With 852A|Patients that received at least one dose of study treatment with 852A (0.6 mg/m^2 to 1.2 mg/m^2 dose, 2 times/week for 12 weeks).
1193461|NCT00319748|O1|Outcome|Patients Treated With 852A|Difference in range values from pre-treatment to post-treatment for cytokine level of TNF-a in patients treated with 852A.
1193462|NCT00319748|O1|Outcome|Patients Treated With 852A|Difference in range values from pre-treatment to post-treatment for cytokine level of sCD40L in patients treated with 852A.
1193463|NCT00319748|O1|Outcome|Patients Treated With 852A|Difference in range values from pre-treatment to post-treatment for cytokine level of MIP-1b in patients treated with 852A.
1193464|NCT00319748|O1|Outcome|Patients Treated With 852A|Difference in range values from pre-treatment to post-treatment for Macrophage Inflammatory Protein-1 Alpha (cytokine) level in patients treated with 852A.
1193465|NCT00319748|O1|Outcome|Patients Treated With 852A|Difference in range values from pre-treatment to post-treatment for cytokine level of IP-10 in patients treated with 852A.
1193466|NCT00319748|O1|Outcome|Patients Treated With 852A|Difference in range values from pre-treatment to post-treatment for cytokine level of IL1ra in patients treated with 852A.
1195598|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
1193467|NCT00319748|O1|Outcome|Patients With Ovarian Cancer|Participants with ovarian cancer who received all 24 doses of 852A.
1193468|NCT00319748|E1|Reported Event|Patients Treated With 852A Study Drug|Patients that received at least one dose of study treatment with 852A (0.6 mg/m^2 to 1.2 mg/m^2 dose, 2 times/week for 12 weeks).
1193469|NCT00319735|B1|Baseline|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
1193513|NCT00319644|O2|Outcome|Tracheal Aspirates|No intervention. Standard of care in ICU. the aspirates were sent for micro culture.
1193470|NCT00319735|P1|Participant Flow|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
1193471|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
1193472|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
1193473|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
1193474|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
1193475|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
1193476|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36 Combined with radiation therapy for six weeks. Surgical esophageal resection after 6 to 8 week rest period.~Subjects who consent will provide tissue samples.~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
1193500|NCT00319696|O5|Outcome|At Least 4 New Ulcers|Number of new DUs includes the new number at each visit and the transient ulcers between visits.
1193501|NCT00319696|O4|Outcome|At Least 3 New Ulcers|Number of new DUs includes the new number at each visit and the transient ulcers between visits.
1193502|NCT00319696|O3|Outcome|At Least 2 New Ulcers|Number of new DUs includes the new number at each visit and the transient ulcers between visits.
1193503|NCT00319696|O2|Outcome|At Least 1 New Ulcer|Number of new DUs includes the new number at each visit and the transient ulcers between visits.
1193477|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
1193514|NCT00319644|O1|Outcome|Mini-BAL|BAL for quantitative culture as TA group.
1193515|NCT00319644|E2|Reported Event|Tracheal Aspirates|No intervention. Standard of care in ICU.
1193516|NCT00319644|E1|Reported Event|Minibal Arm|Using Mini bronchoalveolar lavage
1193478|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36 Combined with radiation therapy for six weeks. Surgical esophageal resection after 6 to 8 week rest period.~Subjects who consent will provide tissue samples.~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
1193479|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
1193480|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36 Combined with radiation therapy for six weeks. Surgical esophageal resection after 6 to 8 week rest period.~Subjects who consent will provide tissue samples.~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
1193481|NCT00319735|E1|Reported Event|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
1193482|NCT00319696|B1|Baseline|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
1193483|NCT00319696|P1|Participant Flow|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
1193484|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
1193485|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
1193486|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
1193487|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
1193488|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
1193489|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
1193490|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
1193491|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
1193492|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
1193493|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
1193494|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
1193495|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
1193496|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
1193497|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
1193498|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
1193499|NCT00319696|O6|Outcome|At Least 5 New Ulcers|Number of new DUs includes the new number at each visit and the transient ulcers between visits.
1193635|NCT00319046|O1|Outcome|Miglustat|miglustat oral capsules 100mg three times a day
1193504|NCT00319696|O1|Outcome|0 New Ulcers|Number of new DUs includes the new number at each visit and the transient ulcers between visits.
1193505|NCT00319696|E1|Reported Event|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
1193506|NCT00319644|B3|Baseline|Total|Total of all reporting groups
1193507|NCT00319644|B2|Baseline|Tracheal Aspirates|No intervention. Standard of care in ICU.
1193508|NCT00319644|B1|Baseline|Minibal Arm|Using Mini bronchoalveolar lavage
1193509|NCT00319644|P2|Participant Flow|Minibal Arm|Using Mini bronchoalveolar lavage
1193519|NCT00319592|B1|Baseline|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
1193520|NCT00319592|P2|Participant Flow|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
1193521|NCT00319592|P1|Participant Flow|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
1193522|NCT00319592|O2|Outcome|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
1193523|NCT00319592|O1|Outcome|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
1193524|NCT00319592|O2|Outcome|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
1193525|NCT00319592|O1|Outcome|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
1193526|NCT00319592|O2|Outcome|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
1193527|NCT00319592|O1|Outcome|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
1193528|NCT00319592|O2|Outcome|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
1193529|NCT00319592|O1|Outcome|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
1193530|NCT00319592|O2|Outcome|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
1193531|NCT00319592|O1|Outcome|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
1193532|NCT00319592|E2|Reported Event|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
1193533|NCT00319592|E1|Reported Event|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
1193534|NCT00319553|B3|Baseline|Total|Total of all reporting groups
1193535|NCT00319553|B2|Baseline|Boostrix® Vaccine Group|
1193536|NCT00319553|B1|Baseline|Adacel® Vaccine Group|
1193537|NCT00319553|P2|Participant Flow|Boostrix® Vaccine Group|
1193538|NCT00319553|P1|Participant Flow|Adacel® Vaccine Group|
1193539|NCT00319553|O2|Outcome|Boostrix® Vaccine Group|
1193540|NCT00319553|O1|Outcome|Adacel® Vaccine Group|
1193541|NCT00319553|O2|Outcome|Boostrix® Vaccine Group|
1193542|NCT00319553|O1|Outcome|Adacel® Vaccine Group|
1193543|NCT00319553|O2|Outcome|Boostrix® Vaccine Group|
1193544|NCT00319553|O1|Outcome|Adacel® Vaccine Group|
1193545|NCT00319553|O2|Outcome|Boostrix® Vaccine Group|
1193546|NCT00319553|O1|Outcome|Adacel® Vaccine Group|
1193547|NCT00319553|E2|Reported Event|Boostrix® Vaccine Group|
1193548|NCT00319553|E1|Reported Event|Adacel® Vaccine Group|
1193549|NCT00319501|B3|Baseline|Total|Total of all reporting groups
1193550|NCT00319501|B2|Baseline|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
1193551|NCT00319501|B1|Baseline|Diazepam|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). Additional doses were permissible as needed during the Open-label and Open-label Extension Periods.
1193552|NCT00319501|P2|Participant Flow|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
1193553|NCT00319501|P1|Participant Flow|Diazepam|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). Additional doses were permissible as needed during the Open-label and Open-label Extension Periods.
1195599|NCT00313144|O1|Outcome|Baseline|
1193554|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). Additional doses were permissible during this period.
1193555|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). Additional doses were permissible during this period.
1193556|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). Additional doses were permissible during this period.
1193557|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). Additional doses were permissible during this period.
1199151|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
1193558|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). Additional doses were permissible during this period.
1193559|NCT00319501|O2|Outcome|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
1193560|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
1193561|NCT00319501|O2|Outcome|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
1193562|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
1193563|NCT00319501|O2|Outcome|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
1193564|NCT00319501|O1|Outcome|Diazepam|Participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
1193565|NCT00319501|O2|Outcome|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
1193566|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
1193567|NCT00319501|O2|Outcome|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
1193568|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
1193569|NCT00319501|O1|Outcome|Diazepam|Participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
1193570|NCT00319501|O2|Outcome|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
1193571|NCT00319501|O1|Outcome|Diazepam|Participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
1193572|NCT00319501|E4|Reported Event|Placebo (Double-blind Period)|Participants received a single dose of diazepam-matching solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
1193636|NCT00319046|O1|Outcome|Miglustat|miglustat oral capsules 100mg three times a day
1193573|NCT00319501|E3|Reported Event|Diazepam (Open-label Extension)|Participants continued to receive diazepam in an age- and weight-appropriate dose of administered using a spring-driven, pressure-activated, prefilled autoinjector. Additional doses were permissible as needed at the onset of an ARS episode. Participants were to continue until drug became marketed.
1193574|NCT00319501|E2|Reported Event|Diazepam (Open-label Period)|Participants received an age- and weight-appropriate dose of placebo solution administered using a spring-driven, pressure-activated, prefilled autoinjector. Additional doses were permissible as needed.
1193575|NCT00319501|E1|Reported Event|Diazepam (Double-blind Period)|Participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
1193576|NCT00319449|B3|Baseline|Total|Total of all reporting groups
1193577|NCT00319449|B2|Baseline|Placebo 10 mg|Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
1193578|NCT00319449|B1|Baseline|Ezetimibe 10 mg|Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
1193579|NCT00319449|P2|Participant Flow|Placebo 10 mg|Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
1194499|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
1193580|NCT00319449|P1|Participant Flow|Ezetimibe 10 mg|Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
1193581|NCT00319449|O2|Outcome|Placebo 10 mg|Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
1193582|NCT00319449|O1|Outcome|Ezetimibe 10 mg|Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
1193583|NCT00319449|O2|Outcome|Placebo 10 mg|Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
1193584|NCT00319449|O1|Outcome|Ezetimibe 10 mg|Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
1193585|NCT00319449|O2|Outcome|Placebo 10 mg|Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
1193586|NCT00319449|O1|Outcome|Ezetimibe 10 mg|Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
1193587|NCT00319449|E2|Reported Event|Placebo 10 mg|Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
1193588|NCT00319449|E1|Reported Event|Ezetimibe 10 mg|Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
1193589|NCT00319436|B3|Baseline|Total|Total of all reporting groups
1193590|NCT00319436|B2|Baseline|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
1193591|NCT00319436|B1|Baseline|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child’s emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child’s emotional needs.
1193592|NCT00319436|P2|Participant Flow|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
1193593|NCT00319436|P1|Participant Flow|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
1193637|NCT00319046|O1|Outcome|Miglustat|miglustat oral capsules 100mg three times a day
1193638|NCT00319046|O1|Outcome|Miglustat|miglustat oral capsules 100mg three times a day
1193639|NCT00319046|E1|Reported Event|Miglustat|miglustat oral capsules 100mg three times a day
1193594|NCT00319436|O2|Outcome|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
1193644|NCT00319020|P1|Participant Flow|Patients With Previous Bosentan|"This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablets) during FUTURE 1 and FUTURE 2 (initiatied at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated).~Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
1193595|NCT00319436|O1|Outcome|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
1193596|NCT00319436|O2|Outcome|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
1193597|NCT00319436|O1|Outcome|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
1193598|NCT00319436|O2|Outcome|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
1193599|NCT00319436|O1|Outcome|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
1193600|NCT00319436|O2|Outcome|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
1193640|NCT00319020|B3|Baseline|Total|Total of all reporting groups
1193641|NCT00319020|B2|Baseline|Bosentan-naive Patients|"This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablets) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for Patients with previous bosentan.~Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
1193738|NCT00318591|B2|Baseline|Conveen Uncoated|Uncoated intermittent catheter
1193739|NCT00318591|B1|Baseline|SpeediCath|Hydrophilic coated intermittent catheter
1193608|NCT00319436|E2|Reported Event|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
1193601|NCT00319436|O1|Outcome|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
1193602|NCT00319436|O2|Outcome|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
1193603|NCT00319436|O1|Outcome|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
1193604|NCT00319436|O2|Outcome|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
1193605|NCT00319436|O1|Outcome|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
1193606|NCT00319436|O2|Outcome|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
1193607|NCT00319436|O1|Outcome|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
1193642|NCT00319020|B1|Baseline|Patients With Previous Bosentan|This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablets) during FUTURE 1 and FUTURE 2 (initiation at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated).
1193692|NCT00318708|P2|Participant Flow|Placebo + Fluticasone|placebo clarithromycin + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
1195600|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
1193609|NCT00319436|E1|Reported Event|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child’s emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child’s emotional needs.
1193610|NCT00319254|B1|Baseline|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
1193611|NCT00319254|P1|Participant Flow|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
1193612|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
1193613|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
1193614|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
1193615|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
1193616|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
1193617|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
1193618|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
1193619|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
1193620|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
1193621|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
1193622|NCT00319254|E1|Reported Event|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
1193623|NCT00319111|B1|Baseline|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
1193624|NCT00319111|P1|Participant Flow|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
1193625|NCT00319111|O1|Outcome|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
1193626|NCT00319111|O1|Outcome|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
1193627|NCT00319111|O1|Outcome|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
1193628|NCT00319111|O1|Outcome|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
1193629|NCT00319111|O1|Outcome|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
1193630|NCT00319111|O1|Outcome|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
1193631|NCT00319111|O1|Outcome|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
1193632|NCT00319111|E1|Reported Event|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
1193633|NCT00319046|B1|Baseline|Miglustat|miglustat oral capsules 100mg three times a day
1193634|NCT00319046|P1|Participant Flow|Miglustat|miglustat oral capsules 100mg three times a day
1195601|NCT00313144|O1|Outcome|Baseline|
1193643|NCT00319020|P2|Participant Flow|Bosentan-naive Patients|"This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablets) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for Patients with previous bosentan.~Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
1193645|NCT00319020|O3|Outcome|Total|All patients (bosentan-naive patients and patients treated with film-coated bosentan tablets before enrollment) who received at least one dose of study drug (bosentan dispersible tablets) in the combined FUTURE 1 / FUTURE 2 trial periods.
1194500|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
1193646|NCT00319020|O2|Outcome|Bosentan-naive Patients|"This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for Patients with previous bosentan.~Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
1193647|NCT00319020|O1|Outcome|Patients With Previous Bosentan|This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 (initiation at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated).
1193648|NCT00319020|O3|Outcome|Total|All patients (bosentan-naive patients and patients treated with film-coated bosentan tablets before enrollment) who received at least one dose of study drug (bosentan dispersible tablets) in the combined FUTURE 1 / FUTURE 2 trial periods.
1193649|NCT00319020|O2|Outcome|Bosentan-naive Patients|"This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for Patients with previous bosentan.~Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
1193650|NCT00319020|O1|Outcome|Patients With Previous Bosentan|This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 (initiation at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated).
1193651|NCT00319020|O3|Outcome|Total|All patients (bosentan-naive patients and patients treated with film-coated bosentan tablets before enrollment) who received at least one dose of study drug (bosentan dispersible tablets) in the combined FUTURE 1 / FUTURE 2 trial periods.
1193652|NCT00319020|O2|Outcome|Bosentan-naive Patients|"This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for Patients with previous bosentan.~Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
1193653|NCT00319020|O1|Outcome|Patients With Previous Bosentan|This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 (initiation at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated).
1193654|NCT00319020|O3|Outcome|Total|All patients (bosentan-naive patients and patients treated with film-coated bosentan tablets before enrollment) who received at least one dose of study drug (bosentan dispersible tablets) in the combined FUTURE 1 / FUTURE 2 trial periods.
1193655|NCT00319020|O2|Outcome|Bosentan-naive Patients|"This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for Patients with previous bosentan.~Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
1193656|NCT00319020|O1|Outcome|Patients With Previous Bosentan|This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 (initiation at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated).
1193657|NCT00319020|O3|Outcome|Total|All patients (bosentan-naive patients and patients treated with film-coated bosentan tablets before enrollment) who received at least one dose of study drug (bosentan dispersible tablets) in the combined FUTURE 1 / FUTURE 2 trial periods.
1193658|NCT00319020|O2|Outcome|Bosentan-naive Patients|"This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for Patients with previous bosentan.~Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
1193659|NCT00319020|O1|Outcome|Patients With Previous Bosentan|This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 (initiation at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated).
1193660|NCT00319020|O3|Outcome|Total|All patients (bosentan-naive patients and patients treated with film-coated bosentan tablets before enrollment) who received at least one dose of study drug (bosentan dispersible tablets) in the combined FUTURE 1 / FUTURE 2 trial periods.
1193661|NCT00319020|O2|Outcome|Bosentan-naive Patients|"This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for Patients with previous bosentan.~Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
1193741|NCT00318591|P1|Participant Flow|SpeediCath|Hydrophilic coated intermittent catheter
1193742|NCT00318591|O2|Outcome|Conveen Uncoated|Uncoated intermittent catheter
1193662|NCT00319020|O1|Outcome|Patients With Previous Bosentan|This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 (initiation at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated).
1193663|NCT00319020|O3|Outcome|Total|All patients (bosentan-naive patients and patients treated with film-coated bosentan tablets before enrollment) who received at least one dose of study drug (bosentan dispersible tablets) in the combined FUTURE 1 / FUTURE 2 trial periods.
1193664|NCT00319020|O2|Outcome|Bosentan-naive Patients|"This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for Patients with previous bosentan.~Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
1193665|NCT00319020|O1|Outcome|Patients With Previous Bosentan|This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 (initiation at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated).
1193666|NCT00319020|O3|Outcome|Total|All patients (bosentan-naive patients and patients treated with film-coated bosentan tablets before enrollment) who received at least one dose of study drug (bosentan dispersible tablets) in the combined FUTURE 1 / FUTURE 2 trial periods.
1193667|NCT00319020|O2|Outcome|Bosentan-naive Patients|"This group included patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 according to the same dosing regimen as described for Patients with previous bosentan.~Note: In this single arm trial, data are presented according to whether patients received bosentan or not before enrollment in FUTURE 1 but all the subjects received the study drug according to the same regimen."
1193668|NCT00319020|O1|Outcome|Patients With Previous Bosentan|This group included patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan (dispersible tablet) during FUTURE 1 and FUTURE 2 (initiation at 2 mg/kg b.i.d. for 4 weeks, then up-titrated to the maintenance dose of 4 mg/kg b.i.d. for the next 8 weeks of the FUTURE 1 trial (AC-052- 365) and to be continued in FUTURE 2. The dose could be down-titrated to 2 mg/kg b.i.d. if not tolerated).
1193669|NCT00319020|E3|Reported Event|Single Arm Bosentan_Total|All patients included in Future 1 / FUTURE 2 whether they received bosentan or not bosentan before enrollment in FUTURE 1
1193670|NCT00319020|E2|Reported Event|Bosentan_naive Patients|Patients who were not treated with bosentan before enrollment in FUTURE 1, and received the pediatric formulation of bosentan during FUTURE 1 / FUTURE 2
1193671|NCT00319020|E1|Reported Event|Patients With Previous Bosentan|Patients who already received bosentan (film-coated tablets) before enrollment in FUTURE 1, and then received the pediatric formulation of bosentan during FUTURE 1 / FUTURE 2
1193672|NCT00318929|B1|Baseline|Depakote ER|Dosing regimen from 750 to 1250 mg once a day.
1193673|NCT00318929|P1|Participant Flow|Depakote ER|Dosing regimen from 750 to 1250 mg once a day.
1193674|NCT00318929|O1|Outcome|Depakote ER|Dosing regimen from 750 to 1250 mg once a day.
1193675|NCT00318929|E1|Reported Event|Depakote ER|Dosing regimen from 750 to 1250 mg once a day.
1193676|NCT00318812|B3|Baseline|Total|Total of all reporting groups
1193677|NCT00318812|B2|Baseline|Iron Sucrose|Iron Sucrose q month IV x 6 months
1193678|NCT00318812|B1|Baseline|Heme Iron|Heme Iron Polypeptide 11mg PO tid for 6 months
1193679|NCT00318812|P2|Participant Flow|Iron Sucrose|Iron Sucrose q month IV x 6 months
1193680|NCT00318812|P1|Participant Flow|Heme Iron|Heme Iron Polypeptide 11mg PO tid for 6 months
1193681|NCT00318812|O2|Outcome|Iron Sucrose|Iron Sucrose q month IV x 6 months
1193682|NCT00318812|O1|Outcome|Heme Iron|Heme Iron Polypeptide 11mg PO tid for 6 months
1193683|NCT00318812|O2|Outcome|Iron Sucrose|Iron Sucrose q month IV x 6 months
1193684|NCT00318812|O1|Outcome|Heme Iron|Heme Iron Polypeptide 11mg PO tid for 6 months
1193685|NCT00318812|O2|Outcome|Iron Sucrose|Iron Sucrose q month IV x 6 months
1193686|NCT00318812|O1|Outcome|Heme Iron|Heme Iron Polypeptide 11mg PO tid for 6 months
1193687|NCT00318812|E2|Reported Event|Iron Sucrose|Iron Sucrose q month IV x 6 months
1193688|NCT00318812|E1|Reported Event|Heme Iron|Heme Iron Polypeptide 11mg PO tid for 6 months
1193689|NCT00318708|B3|Baseline|Total|Total of all reporting groups
1193690|NCT00318708|B2|Baseline|Placebo + Fluticasone|Fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid)
1193691|NCT00318708|B1|Baseline|Clarithromycin + Fluticasone|Clarithromycin 500 mg bid (Biaxin) + fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid)
1193693|NCT00318708|P1|Participant Flow|Clarithromycin + Fluticasone|clarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
1193694|NCT00318708|O2|Outcome|Placebo + Fluticasone|placebo clarithromycin + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
1193695|NCT00318708|O1|Outcome|Clarithromycin + Fluticasone|clarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
1193696|NCT00318708|E2|Reported Event|Placebo + Fluticasone|Fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid)
1193697|NCT00318708|E1|Reported Event|Clarithromycin + Fluticasone|Clarithromycin 500 mg bid (Biaxin) + fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid)
1193698|NCT00318656|B3|Baseline|Total|Total of all reporting groups
1193743|NCT00318591|O1|Outcome|SpeediCath|Hydrophilic coated intermittent catheter
1193744|NCT00318591|O2|Outcome|Conveen Uncoated|Uncoated intermittent catheter
1193745|NCT00318591|O1|Outcome|SpeediCath|Hydrophilic coated intermittent catheter
1193746|NCT00318591|O2|Outcome|Conveen Uncoated|Uncoated intermittent catheter
1193699|NCT00318656|B2|Baseline|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
1193700|NCT00318656|B1|Baseline|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
1193701|NCT00318656|P2|Participant Flow|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
1193702|NCT00318656|P1|Participant Flow|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of Rosiglitazone (RSG) and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
1193703|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
1193704|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
1193705|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
1193706|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
1193707|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
1193708|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
1193709|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
1193740|NCT00318591|P2|Participant Flow|Conveen Uncoated|Uncoated intermittent catheter
1193710|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
1193747|NCT00318591|O1|Outcome|SpeediCath|Hydrophilic coated intermittent catheter
1193748|NCT00318591|O2|Outcome|Conveen Uncoated|Uncoated intermittent catheter
1193749|NCT00318591|O1|Outcome|SpeediCath|Hydrophilic coated intermittent catheter
1193750|NCT00318591|O2|Outcome|Conveen Uncoated|Uncoated intermittent catheter
1193751|NCT00318591|O1|Outcome|SpeediCath|Hydrophilic coated intermittent catheter
1193752|NCT00318591|O2|Outcome|Conveen Uncoated|Uncoated intermittent catheter
1193753|NCT00318591|O1|Outcome|SpeediCath Catheter|Hydrophilic coated intermittent catheter
1193711|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
1193712|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
1193713|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
1193714|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
1193715|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
1193716|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
1193717|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
1193718|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
1193719|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
1193720|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
1193721|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
1193722|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
1193736|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
1193737|NCT00318591|B3|Baseline|Total|Total of all reporting groups
1193754|NCT00318591|O2|Outcome|Conveen Uncoated|uncoated intermittent catheter
1193755|NCT00318591|O1|Outcome|SpeediCath Catheter|Hydrophilic coated intermittent catheter
1193756|NCT00318591|E2|Reported Event|Conveen Uncoated|Uncoated intermittent catheter
1193757|NCT00318591|E1|Reported Event|SpeediCath|Hydrophilic coated intermittent catheter
1193723|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
1193724|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
1193725|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
1193726|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
1193727|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
1193728|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
1193729|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
1193730|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
1193731|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
1193732|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
1193733|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
1193734|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
1193735|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
1193758|NCT00318565|B1|Baseline|Ablation Group|Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter.
1193759|NCT00318565|P1|Participant Flow|Ablation Group|Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter.
1193760|NCT00318565|O1|Outcome|Ablation Group|Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter.
1193761|NCT00318565|O1|Outcome|Ablation Group|Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter.
1193762|NCT00318565|E1|Reported Event|Ablation Group|Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter.
1193763|NCT00318474|B3|Baseline|Total|Total of all reporting groups
1193764|NCT00318474|B2|Baseline|Placebo|Subjects receive ACEi and FOS and placebo.
1193765|NCT00318474|B1|Baseline|Mycophenolate Mofetil (MMF)|"Subjects receive ACEi, FOS, and MMF. Dose is based on body size (between 25mg/kg/day and 36mg/kg/day with a maximum dose 1gm BID; initial dose to be used in the first 2 weeks of therapy will be approximately 1/2-2/3 of the full dose). Route of administration is oral. Frequency is daily. MMF will be administered up to 12 months.~Mycophenolate Mofetil (MMF)"
1193766|NCT00318474|P2|Participant Flow|Placebo|Subjects receive ACEi and FOS and placebo.
1193767|NCT00318474|P1|Participant Flow|Mycophenolate Mofetil (MMF)|"Subjects receive angiotensin-converting enzyme inhibitors (ACEi), fish oil supplements (FOS), and MMF. Dose is based on body size (between 25mg/kg/day and 36mg/kg/day with a maximum dose 1gm BID; initial dose to be used in the first 2 weeks of therapy will be approximately 1/2-2/3 of the full dose). Route of administration is oral. Frequency is daily. MMF will be administered up to 12 months.~Mycophenolate Mofetil (MMF)"
1193768|NCT00318474|O2|Outcome|Placebo|Subjects receive ACEi and FOS and placebo.
1193769|NCT00318474|O1|Outcome|Mycophenolate Mofetil (MMF)|"Subjects receive ACEi, FOS, and MMF. Dose is based on body size (between 25mg/kg/day and 36mg/kg/day with a maximum dose 1gm BID; initial dose to be used in the first 2 weeks of therapy will be approximately 1/2-2/3 of the full dose). Route of administration is oral. Frequency is daily. MMF will be administered up to 12 months.~Mycophenolate Mofetil (MMF)"
1193770|NCT00318474|E2|Reported Event|Placebo|Subjects receive ACEi and FOS and placebo.
1193771|NCT00318474|E1|Reported Event|Mycophenolate Mofetil (MMF)|"Subjects receive ACEi, FOS, and MMF. Dose is based on body size (between 25mg/kg/day and 36mg/kg/day with a maximum dose 1gm BID; initial dose to be used in the first 2 weeks of therapy will be approximately 1/2-2/3 of the full dose). Route of administration is oral. Frequency is daily. MMF will be administered up to 12 months.~Mycophenolate Mofetil (MMF)"
1193772|NCT00318461|B6|Baseline|Total|Total of all reporting groups
1193773|NCT00318461|B5|Baseline|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193774|NCT00318461|B4|Baseline|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193775|NCT00318461|B3|Baseline|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193776|NCT00318461|B2|Baseline|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193777|NCT00318461|B1|Baseline|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193778|NCT00318461|P5|Participant Flow|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193779|NCT00318461|P4|Participant Flow|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193780|NCT00318461|P3|Participant Flow|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193781|NCT00318461|P2|Participant Flow|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1194202|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
1194203|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
1193782|NCT00318461|P1|Participant Flow|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193783|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193784|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193785|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193786|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193787|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1194501|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
1193788|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193789|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193790|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193791|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193792|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193793|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193794|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193795|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193796|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193797|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193798|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193799|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193800|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193801|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193802|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193803|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193804|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193805|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193806|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193807|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193808|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193809|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193952|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
1193810|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193811|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193812|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193813|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193814|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193815|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193816|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193817|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193818|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193819|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193820|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193821|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193822|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193823|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193824|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193825|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193826|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193827|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193828|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193829|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193830|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193831|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193832|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193833|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193834|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193835|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193836|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193837|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193953|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
1193838|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193839|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193840|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193841|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193842|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193843|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193844|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193845|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193846|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193847|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193848|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193849|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193850|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193851|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193852|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193853|NCT00318461|E5|Reported Event|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193854|NCT00318461|E4|Reported Event|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193855|NCT00318461|E3|Reported Event|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193856|NCT00318461|E2|Reported Event|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193857|NCT00318461|E1|Reported Event|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
1193858|NCT00318409|B3|Baseline|Total|Total of all reporting groups
1193859|NCT00318409|B2|Baseline|Placebo|Placebo 300mg daily
1193860|NCT00318409|B1|Baseline|Bupropion|Bupropion XL 300mg daily
1193861|NCT00318409|P2|Participant Flow|Placebo|Placebo 300mg daily
1193862|NCT00318409|P1|Participant Flow|Bupropion|Bupropion XL 300mg daily
1193863|NCT00318409|O2|Outcome|Placebo|
1193864|NCT00318409|O1|Outcome|Bupropion|
1193865|NCT00318409|O2|Outcome|Placebo|
1193866|NCT00318409|O1|Outcome|Bupropion|
1193867|NCT00318409|O2|Outcome|Placebo|
1193868|NCT00318409|O1|Outcome|Bupropion|
1193869|NCT00318409|O2|Outcome|Placebo|
1193870|NCT00318409|O1|Outcome|Bupropion|
1193871|NCT00318409|O2|Outcome|Placebo|
1193872|NCT00318409|O1|Outcome|Bupropion|
1193873|NCT00318409|O2|Outcome|Placebo|
1193874|NCT00318409|O1|Outcome|Bupropion|
1193875|NCT00318409|O2|Outcome|Placebo|
1193876|NCT00318409|O1|Outcome|Bupropion|
1193877|NCT00318409|O1|Outcome|Persons Screened|
1193878|NCT00318409|E2|Reported Event|Placebo|
1193879|NCT00318409|E1|Reported Event|Bupropion|
1193880|NCT00318370|B1|Baseline|Far Only and Chemo Plus Far and Maintenance Far Only|"Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).~Chemo+Far: paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle plus farletuzumab, 100 mg/m2.~Maintenance Far Only: farletuzumab, 100 milligrams (mg)/square meter (m2) for those subjects who completed the Period, Chemo Plus Far."
1193881|NCT00318370|P3|Participant Flow|Maintenance Far Only|Maintenance Far Only: farletuzumab, 100 milligrams (mg)/square meter (m2) for those subjects who completed Period 2, Chemo Plus Far.
1193882|NCT00318370|P2|Participant Flow|Chemo Plus Far|Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.
1193883|NCT00318370|P1|Participant Flow|Far Only|Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).
1193884|NCT00318370|O1|Outcome|Chemo Plus Far Plus Maintenance Far Only|"Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.~Maintenace Far Only: farletuzumab, 100 mg/m2"
1193885|NCT00318370|O1|Outcome|Chemo Plus Far Plus Maintenance Far Only|"Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.~Maintenace Far Only: farletuzumab, 100 mg/m2"
1193886|NCT00318370|O1|Outcome|Chemo Plus Far|Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.
1194502|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
1193887|NCT00318370|O1|Outcome|Chemo Plus Far|Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.
1193888|NCT00318370|O1|Outcome|Chemo Plus Far|Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.
1193889|NCT00318370|O1|Outcome|Chemo Plus Far|Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.
1193890|NCT00318370|O1|Outcome|Far Only|Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).
1193891|NCT00318370|E1|Reported Event|Far Only and Chemo Plus Far and Maintenance Far Only|"Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).~Chemo+Far: paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle plus farletuzumab, 100 mg/m2.~Maintenance Far Only: farletuzumab, 100 milligrams (mg)/square meter (m2) for those subjects who completed the Period, Chemo Plus Far."
1193892|NCT00317239|B3|Baseline|Total|Total of all reporting groups
1193893|NCT00317239|B2|Baseline|Ferrous Sulfate Tablets|325 mg/TID x 8 weeks
1193894|NCT00317239|B1|Baseline|Ferric Carboxymaltose (FCM)|A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
1193895|NCT00317239|P2|Participant Flow|Ferrous Sulfate Tablets|325 mg/TID x 8 weeks
1193896|NCT00317239|P1|Participant Flow|Ferric Carboxymaltose (FCM)|A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
1193897|NCT00317239|O2|Outcome|Ferrous Sulfate Tablets|325 mg/TID x 8 weeks
1193898|NCT00317239|O1|Outcome|Ferric Carboxymaltose (FCM)|A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
1193899|NCT00317239|E2|Reported Event|Ferrous Sulfate Tablets|325 mg/TID x 8 weeks
1193900|NCT00317239|E1|Reported Event|Ferric Carboxymaltose (FCM)|A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
1193901|NCT00317226|B1|Baseline|Ferric Carboxymaltose (FCM)|maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit based on TSAT and Ferritin levels
1193902|NCT00317226|P1|Participant Flow|Ferric Carboxymaltose (FCM)|maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit based on TSAT and Ferritin levels
1193903|NCT00317226|O1|Outcome|Ferric Carboxymaltose (FCM)|maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit based on TSAT and Ferritin levels
1193904|NCT00317226|E1|Reported Event|Ferric Carboxymaltose (FCM)|maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit based on TSAT and Ferritin levels
1193905|NCT00318292|B3|Baseline|Total|Total of all reporting groups
1193906|NCT00318292|B2|Baseline|Placebo|Placebo for preemptive local analgesia.
1193907|NCT00318292|B1|Baseline|Preemptive Local Analgesia (PLA)|Active preemptive local analgesia.
1193908|NCT00318292|P2|Participant Flow|Placebo|Placebo for preemptive local analgesia.
1193909|NCT00318292|P1|Participant Flow|Preemptive Local Analgesia (PLA)|Active preemptive local analgesia.
1193910|NCT00318292|O2|Outcome|Placebo|Placebo for preemptive local analgesia.
1193911|NCT00318292|O1|Outcome|Preemptive Local Analgesia (PLA)|Active preemptive local analgesia.
1193912|NCT00318292|E2|Reported Event|Placebo|Placebo for preemptive local analgesia.
1193913|NCT00318292|E1|Reported Event|Preemptive Local Analgesia (PLA)|Active preemptive local analgesia.
1193914|NCT00318136|B1|Baseline|Treated With Bevacizumab|Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
1193915|NCT00318136|P1|Participant Flow|Treated With Bevacizumab|Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
1193916|NCT00318136|O1|Outcome|Treated With Bevacizumab|Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
1193917|NCT00318136|O1|Outcome|Treated With Bevacizumab|Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
1194132|NCT00317044|E2|Reported Event|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
1193918|NCT00318136|O1|Outcome|Treated With Bevacizumab|Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
1193919|NCT00318136|O1|Outcome|Treated With Bevacizumab|Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
1193920|NCT00318136|E1|Reported Event|Treated With Bevacizumab|Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
1193921|NCT00317941|B3|Baseline|Total|Total of all reporting groups
1193922|NCT00317941|B2|Baseline|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
1193923|NCT00317941|B1|Baseline|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
1194503|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
1193924|NCT00317941|P3|Participant Flow|Group C: IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
1193925|NCT00317941|P2|Participant Flow|Group B: IFNB-1b 250 Mcg (Betaseron) Via Betaject Light|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject Light
1193926|NCT00317941|P1|Participant Flow|Group A: IFNB-1b 250 Mcg (Betaseron) Via Betaject|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject
1193927|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
1193928|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
1193929|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
1193930|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
1193931|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
1193932|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron) Via Betaject|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject
1193933|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
1193934|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron) Via Betaject|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject
1193935|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
1193936|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron) Via Betaject|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject
1193937|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
1193938|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron) Via Betaject|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject
1193939|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
1193940|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
1193941|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
1193942|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
1193943|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
1193944|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
1193945|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
1193946|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
1193947|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
1193948|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
1193949|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
1193950|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
1193951|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
1194204|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
1193954|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
1193955|NCT00317941|O3|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
1193956|NCT00317941|O2|Outcome|IFNB-1b 250 Mcg (Betaseron) Via Betaject Light|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject Light
1193957|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron) Via Betaject|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject
1193958|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
1193959|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
1199152|NCT00301262|O3|Outcome|DB Placebo Week 8|
1193960|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
1193961|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
1193962|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
1193963|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
1193964|NCT00317941|E2|Reported Event|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II. Participants at risk from Group C in Participant flow.
1193965|NCT00317941|E1|Reported Event|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light. Participants at risk from Group A and Group B in Participant flow.
1193966|NCT00317720|B1|Baseline|Trastuzumab + RAD001|Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 10 mg given orally daily.
1193967|NCT00317720|P2|Participant Flow|BIDMC/DFCI Trastuzumab + RAD001|"Phase I: Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 5 or 10 mg by mouth daily.~Phase II: RAD001 10 mg/kg daily~ClinicalTrials.gov ID NCT00458237"
1193968|NCT00317720|P1|Participant Flow|MDACC Trastuzumab + RAD001|"Phase I: Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 (Everolimus) 10 mg orally (PO) daily.~Phase II: RAD001 10 mg/kg daily + Trastuzumab 6 mg/kg maintenance dose~ClinicalTrials.gov ID: NCT00317720"
1193969|NCT00317720|O1|Outcome|Trastuzumab + RAD001|Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 10 mg PO (by mouth) daily.
1193970|NCT00317720|O1|Outcome|Trastuzumab + RAD001|Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 10 mg PO (by mouth) daily.
1193971|NCT00317720|E1|Reported Event|Trastuzumab + RAD001|Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 10 mg PO (by mouth) daily.
1193972|NCT00317642|B3|Baseline|Total|Total of all reporting groups
1193973|NCT00317642|B2|Baseline|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1193974|NCT00317642|B1|Baseline|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1193975|NCT00317642|P2|Participant Flow|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1193976|NCT00317642|P1|Participant Flow|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1193977|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1193978|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1193979|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1193980|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1193981|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1194142|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
1194504|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
1193982|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1193983|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1193984|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1193985|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1193986|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1193987|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1193988|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1193989|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1193990|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1193991|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1193992|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1193993|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1193994|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1194133|NCT00317044|E1|Reported Event|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
1193995|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1193996|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1199153|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
1193997|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1193998|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1193999|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1194000|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1194001|NCT00317642|O2|Outcome|Placebo and Cytarabine (FAS)|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1194002|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine (FAS)|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1194003|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1194004|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1194005|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1194006|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1194007|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1194008|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1194009|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1194134|NCT00316914|B3|Baseline|Total|Total of all reporting groups
1194135|NCT00316914|B2|Baseline|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
1194010|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1194011|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1194012|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1194013|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1194014|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1194015|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1194016|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1194017|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1194018|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1194019|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1194020|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1194021|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1194022|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1194023|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1194024|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1194205|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
1194206|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
1194025|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1194026|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1194027|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1194028|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1194029|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1194030|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1194031|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1194032|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1194033|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1194034|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1194035|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1194036|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1194037|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1194038|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1194039|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1194136|NCT00316914|B1|Baseline|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
1195602|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
1194040|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1194041|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1194042|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1194043|NCT00317642|O2|Outcome|Placebo and Cytarabine (FAS)|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1194044|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine (FAS)|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1194045|NCT00317642|E3|Reported Event|Overall|Combined total for the two Arms/Groups
1194046|NCT00317642|E2|Reported Event|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
1194047|NCT00317642|E1|Reported Event|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
1194048|NCT00317109|B3|Baseline|Total|Total of all reporting groups
1194049|NCT00317109|B2|Baseline|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194050|NCT00317109|B1|Baseline|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194051|NCT00317109|P2|Participant Flow|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194052|NCT00317109|P1|Participant Flow|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194053|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194054|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194055|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1195603|NCT00313144|O1|Outcome|Baseline|
1194056|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194143|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
1194216|NCT00316706|B2|Baseline|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
1194057|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194058|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194059|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194060|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194061|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194062|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194063|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194064|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194065|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194066|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194067|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194068|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194137|NCT00316914|P2|Participant Flow|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
1194138|NCT00316914|P1|Participant Flow|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
1194082|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194069|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194070|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194071|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194072|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194073|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194074|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194075|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194076|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194077|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194078|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194079|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194080|NCT00317109|O1|Outcome|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194081|NCT00317109|O2|Outcome|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194139|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
1194207|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
1194208|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
1194083|NCT00317109|E2|Reported Event|Tritanrix-HepB/Hiberix-Mencevax AC Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™-Mencevax™ AC vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194084|NCT00317109|E1|Reported Event|Tritanrix-HepB/Hiberix Group|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317122), were boosted in the current study with one dose of the same vaccine at 15 to 18 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1194085|NCT00317044|B4|Baseline|Total|Total of all reporting groups
1194086|NCT00317044|B3|Baseline|Placebo|Placebo
1194087|NCT00317044|B2|Baseline|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
1194088|NCT00317044|B1|Baseline|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
1194089|NCT00317044|P3|Participant Flow|Placebo|Placebo
1194090|NCT00317044|P2|Participant Flow|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
1194091|NCT00317044|P1|Participant Flow|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
1194092|NCT00317044|O3|Outcome|Placebo|Placebo
1194093|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
1194094|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
1194095|NCT00317044|O3|Outcome|Placebo|Placebo
1194096|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
1194097|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
1194098|NCT00317044|O3|Outcome|Placebo|Placebo
1194099|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
1194100|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
1194101|NCT00317044|O3|Outcome|Placebo|Placebo
1194102|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
1194103|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
1194104|NCT00317044|O3|Outcome|Placebo|Placebo
1194105|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
1194106|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
1194107|NCT00317044|O3|Outcome|Placebo|Placebo
1194108|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
1194109|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
1194110|NCT00317044|O3|Outcome|Placebo|Placebo
1194111|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
1194112|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
1194113|NCT00317044|O3|Outcome|Placebo|Placebo
1194114|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
1194115|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
1194116|NCT00317044|O3|Outcome|Placebo|Placebo
1194117|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
1194118|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
1194119|NCT00317044|O3|Outcome|Placebo|Placebo
1194120|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
1194121|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
1194122|NCT00317044|O3|Outcome|Placebo|Placebo
1194123|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
1194124|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
1194125|NCT00317044|O3|Outcome|Placebo|Placebo
1194126|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
1194127|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
1194128|NCT00317044|O3|Outcome|Placebo|Placebo
1194129|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
1194130|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
1194131|NCT00317044|E3|Reported Event|Placebo|Placebo
1194198|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
1194140|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
1194141|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
1194144|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
1194145|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
1194146|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
1194147|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
1194148|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
1194149|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
1194150|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
1194151|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
1194152|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
1194153|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
1194154|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
1194155|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
1194156|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
1194157|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
1194158|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
1194159|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
1194160|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
1194161|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
1194162|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
1194163|NCT00316914|E2|Reported Event|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
1194164|NCT00316914|E1|Reported Event|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
1194165|NCT00316888|B3|Baseline|Total|Total of all reporting groups
1194166|NCT00316888|B2|Baseline|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
1194167|NCT00316888|B1|Baseline|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
1194199|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
1194200|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
1194168|NCT00316888|P2|Participant Flow|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
1194214|NCT00316719|E1|Reported Event|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
1194215|NCT00316706|B3|Baseline|Total|Total of all reporting groups
1194254|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
1194169|NCT00316888|P1|Participant Flow|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
1194170|NCT00316888|O2|Outcome|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
1194171|NCT00316888|O1|Outcome|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
1194172|NCT00316888|O2|Outcome|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
1194173|NCT00316888|O1|Outcome|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
1194174|NCT00316888|O2|Outcome|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
1194175|NCT00316888|O1|Outcome|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
1194176|NCT00316888|O2|Outcome|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
1194177|NCT00316888|O1|Outcome|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
1194178|NCT00316888|O2|Outcome|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
1194179|NCT00316888|O1|Outcome|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
1194201|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
1194180|NCT00316888|E2|Reported Event|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
1194181|NCT00316888|E1|Reported Event|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
1194182|NCT00316862|B1|Baseline|Treatment (Chemotherapy, Chemoradiotherapy, Surgery)|"INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin 30 mg/m^2 intravenously (IV) over 30 minutes and irinotecan hydrochloride 65 mg/m^2 IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor."
1194183|NCT00316862|P1|Participant Flow|Treatment (Chemotherapy, Chemoradiotherapy, Surgery)|"INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin 30 mg/m^2 intravenously (IV) over 30 minutes and irinotecan hydrochloride 65 mg/m^2 IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor."
1194184|NCT00316862|O1|Outcome|Treatment (Chemotherapy, Chemoradiotherapy, Surgery)|"INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin 30 mg/m^2 intravenously (IV) over 30 minutes and irinotecan hydrochloride 65 mg/m^2 IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor."
1194185|NCT00316862|O1|Outcome|Treatment (Chemotherapy, Chemoradiotherapy, Surgery)|"INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin 30 mg/m^2 intravenously (IV) over 30 minutes and irinotecan hydrochloride 65 mg/m^2 IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor."
1194186|NCT00316862|O1|Outcome|Treatment (Chemotherapy, Chemoradiotherapy, Surgery)|"INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin 30 mg/m^2 intravenously (IV) over 30 minutes and irinotecan hydrochloride 65 mg/m^2 IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor."
1194187|NCT00316862|E1|Reported Event|Treatment (Chemotherapy, Chemoradiotherapy, Surgery)|"INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin 30 mg/m^2 intravenously (IV) over 30 minutes and irinotecan hydrochloride 65 mg/m^2 IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor."
1194188|NCT00316719|B3|Baseline|Total|Total of all reporting groups
1194189|NCT00316719|B2|Baseline|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
1194190|NCT00316719|B1|Baseline|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
1194191|NCT00316719|P2|Participant Flow|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
1194192|NCT00316719|P1|Participant Flow|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
1194193|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
1194194|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
1194195|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
1194196|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
1194197|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
1194209|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
1194210|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
1194211|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
1194212|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
1194213|NCT00316719|E2|Reported Event|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
1199154|NCT00301262|O1|Outcome|DB Viagra Week 8|
1194217|NCT00316706|B1|Baseline|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
1194218|NCT00316706|P2|Participant Flow|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
1194219|NCT00316706|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
1194220|NCT00316706|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
1194221|NCT00316706|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
1194222|NCT00316706|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
1194223|NCT00316706|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
1194224|NCT00316706|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
1194225|NCT00316706|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
1194226|NCT00316706|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
1194227|NCT00316706|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
1194228|NCT00316706|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
1194229|NCT00316706|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
1194230|NCT00316706|E2|Reported Event|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
1194231|NCT00316706|E1|Reported Event|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
1194232|NCT00316693|B3|Baseline|Total|Total of all reporting groups
1194233|NCT00316693|B2|Baseline|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
1194234|NCT00316693|B1|Baseline|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
1194235|NCT00316693|P2|Participant Flow|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
1194236|NCT00316693|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
1194237|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
1194238|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
1194239|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
1194240|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
1194241|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
1194242|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
1194243|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
1194244|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
1194245|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
1194246|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
1194247|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
1194248|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
1195604|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
1194249|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
1194250|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
1194251|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
1194252|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
1194253|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
1194505|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
1194255|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
1194256|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
1194257|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
1194258|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
1194259|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
1194260|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
1194261|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
1194262|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
1194263|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
1194264|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
1194265|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
1194266|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
1194267|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
1194268|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
1194269|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
1194270|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
1194271|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
1194272|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
1194273|NCT00316693|E2|Reported Event|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
1194274|NCT00316693|E1|Reported Event|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
1194275|NCT00316355|B3|Baseline|Total|Total of all reporting groups
1194276|NCT00316355|B2|Baseline|Stepped-Care CBT|"Stepped-care CBT~Stepped-Care CBT: In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP)."
1194277|NCT00316355|B1|Baseline|Traditional CBT|"Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)~Traditional CBT: CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention."
1194278|NCT00316355|P2|Participant Flow|Stepped-Care CBT|"Stepped-care CBT~Stepped-Care CBT: In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP)."
1194279|NCT00316355|P1|Participant Flow|Traditional CBT|"Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)~Cognitive-Behavioral Therapy with EX/RP: CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention."
1194280|NCT00316355|O2|Outcome|Stepped-Care CBT|"Stepped-care CBT~Stepped-Care CBT: In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP)."
1194281|NCT00316355|O1|Outcome|Traditional CBT|"Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)~Cognitive-Behavioral Therapy with EX/RP: CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention."
1194282|NCT00316355|O2|Outcome|Stepped-Care CBT|"Stepped-care CBT~Stepped-Care CBT: In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP)."
1194399|NCT00316225|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
1194283|NCT00316355|O1|Outcome|Traditional CBT|"Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)~Cognitive-Behavioral Therapy with EX/RP: CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention."
1194284|NCT00316355|E2|Reported Event|Stepped-Care CBT|"Stepped-care CBT~Stepped-Care CBT: In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP)."
1194370|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1199155|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
1194285|NCT00316355|E1|Reported Event|Traditional CBT|"Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)~Cognitive-Behavioral Therapy with EX/RP: CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention."
1194286|NCT00316303|B3|Baseline|Total|Total of all reporting groups
1194287|NCT00316303|B2|Baseline|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, hepatitis A (HAV) and hepatitis B (HBV)immunizations, and any necessary treatments.
1194288|NCT00316303|B1|Baseline|STIRR Intervention|The STIRR Intervention involves Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
1194289|NCT00316303|P2|Participant Flow|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, hepatitis A (HAV) and hepatitis B (HBV)immunizations, and any necessary treatments.
1194290|NCT00316303|P1|Participant Flow|STIRR Intervention|The STIRR Intervention involves Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
1194291|NCT00316303|O2|Outcome|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, HAV and HBV immunizations, and any necessary treatments.
1194292|NCT00316303|O1|Outcome|STIRR Intervention|The STIRR Intervention involved Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
1194293|NCT00316303|O2|Outcome|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, HAV and HBV immunizations, and any necessary treatments.
1194294|NCT00316303|O1|Outcome|STIRR Intervention|The STIRR Intervention involved Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
1194295|NCT00316303|O2|Outcome|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, HAV and HBV immunizations, and any necessary treatments.
1194296|NCT00316303|O1|Outcome|STIRR Intervention|The STIRR Intervention involved Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
1194297|NCT00316303|O2|Outcome|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, hepatitis A and hepatitis B immunizations, and any necessary treatments.
1194298|NCT00316303|O1|Outcome|STIRR Intervention|The STIRR Intervention involved Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
1194299|NCT00316303|O2|Outcome|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, hepatitis A (HAV) and hepatitis B (HBV)immunizations, and any necessary treatments.
1194300|NCT00316303|O1|Outcome|STIRR Intervention|The STIRR Intervention involves Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
1194301|NCT00316303|E2|Reported Event|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, HAV and HBV immunizations, and any necessary treatments.
1194302|NCT00316303|E1|Reported Event|STIRR Intervention|The STIRR Intervention involved Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
1194303|NCT00316277|B3|Baseline|Total|Total of all reporting groups
1194304|NCT00316277|B2|Baseline|Buprenorphine/Nx With SMM|All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
1194305|NCT00316277|B1|Baseline|Buprenorphine/Nx With EMM|All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional.
1194306|NCT00316277|P2|Participant Flow|Buprenorphine/Nx With SMM|All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
1194307|NCT00316277|P1|Participant Flow|Buprenorphine/Nx With EMM|All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional.
1194506|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
1194308|NCT00316277|O2|Outcome|Buprenorphine/Nx With SMM|All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
1194309|NCT00316277|O1|Outcome|Buprenorphine/Nx With EMM|All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional.
1194310|NCT00316277|O2|Outcome|Success in Phase 2 Among Participants Without Heroin Use|
1194311|NCT00316277|O1|Outcome|Success in Phase 2 Among Participants With Heroin Use|
1194312|NCT00316277|O2|Outcome|Success in Phase 1 Among Participants Without Heroin Use|
1194313|NCT00316277|O1|Outcome|Success in Phase 1 Among Participants With Heroin Use|
1194314|NCT00316277|O2|Outcome|Success in Phase 2 Among Participants Without Chronic Pain|
1194315|NCT00316277|O1|Outcome|Success in Phase 2 Among Participants With Chronic Pain|"Patients were designated at baseline as having current chronic pain if they reported pain other than everyday kinds of pain excluding withdrawal-related pain, for at least 3 months."
1194316|NCT00316277|O2|Outcome|Success in Phase 1 Among Participants Without Chronic Pain|
1194317|NCT00316277|O1|Outcome|Success in Phase 1 Among Participants With Chronic Pain|"Patients were designated at baseline as having current chronic pain if they reported pain other than everyday kinds of pain excluding withdrawal-related pain, for at least 3 months."
1194318|NCT00316277|O2|Outcome|Buprenorphine/Nx With SMM|All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
1194319|NCT00316277|O1|Outcome|Buprenorphine/Nx With EMM|All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional.
1194320|NCT00316277|O2|Outcome|Buprenorphine/Nx With SMM|All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
1194321|NCT00316277|O1|Outcome|Buprenorphine/Nx With EMM|All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional.
1194322|NCT00316277|E2|Reported Event|Buprenorphine/Nx With SMM|All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
1194323|NCT00316277|E1|Reported Event|Buprenorphine/Nx With EMM|All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional.
1194324|NCT00316264|B4|Baseline|Total|Total of all reporting groups
1194325|NCT00316264|B3|Baseline|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194326|NCT00316264|B2|Baseline|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194327|NCT00316264|B1|Baseline|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194328|NCT00316264|P3|Participant Flow|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194329|NCT00316264|P2|Participant Flow|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194330|NCT00316264|P1|Participant Flow|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194331|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194332|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194333|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194334|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194335|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194400|NCT00316225|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
1194336|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194337|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194338|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194339|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194340|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194341|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194342|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194343|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194344|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194345|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194346|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194347|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194348|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194349|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194350|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194351|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194352|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194353|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194354|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194355|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194356|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194357|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194358|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194359|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194360|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194361|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194362|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194363|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194364|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194365|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194366|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
1195605|NCT00313144|O1|Outcome|Baseline|
1194367|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194368|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194369|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194371|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194372|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194373|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194374|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194375|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194376|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194377|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194378|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194379|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194380|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194381|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194382|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194383|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194384|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194385|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194386|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194387|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194388|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194389|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194390|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194391|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194392|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194393|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194394|NCT00316264|E3|Reported Event|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194395|NCT00316264|E2|Reported Event|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194396|NCT00316264|E1|Reported Event|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
1194397|NCT00316225|B1|Baseline|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
1194398|NCT00316225|P1|Participant Flow|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
1194401|NCT00316225|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
1194402|NCT00316225|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
1194403|NCT00316225|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
1194404|NCT00316225|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
1194405|NCT00316225|E1|Reported Event|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
1194406|NCT00316199|B1|Baseline|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.~Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
1194407|NCT00316199|P1|Participant Flow|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.~Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
1194408|NCT00316199|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.~Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
1194409|NCT00316199|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.~Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
1194410|NCT00316199|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.~Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
1194411|NCT00316199|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.~Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
1194412|NCT00316199|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.~Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
1194413|NCT00316199|E1|Reported Event|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.~Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
1194414|NCT00316186|B1|Baseline|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
1194415|NCT00316186|P1|Participant Flow|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
1194416|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
1194417|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
1194418|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
1194419|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
1194420|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
1194421|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
1194422|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
1194423|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
1194424|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
1194425|NCT00316186|E1|Reported Event|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
1194426|NCT00316173|B3|Baseline|Total|Total of all reporting groups
1194427|NCT00316173|B2|Baseline|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
1194428|NCT00316173|B1|Baseline|Dose-finding Phase|Starting dose of 2.0 milligrams (mg)/square meter (m2) topotecan (Days 1 and 8, every 21 days) and area under the curve (AUC) 5 carboplatin (Day 1 every 21 days)
1194429|NCT00316173|P2|Participant Flow|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
1194430|NCT00316173|P1|Participant Flow|Dose-finding Phase|Starting dose of 2.0 milligrams (mg)/square meter (m2) topotecan (Days 1 and 8, every 21 days) and area under the curve (AUC) 5 carboplatin (Day 1 every 21 days)
1194431|NCT00316173|O1|Outcome|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
1194432|NCT00316173|O1|Outcome|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
1194433|NCT00316173|O1|Outcome|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
1194434|NCT00316173|O1|Outcome|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
1194435|NCT00316173|O1|Outcome|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
1194455|NCT00316082|P5|Participant Flow|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
1194436|NCT00316173|O1|Outcome|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
1194437|NCT00316173|O1|Outcome|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
1194458|NCT00316082|P2|Participant Flow|Saxagliptin 5 mg QAM|The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
1194438|NCT00316173|E2|Reported Event|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
1194439|NCT00316173|E1|Reported Event|Dose-finding Phase|Starting dose of 2.0 milligrams (mg)/square meter (m2) topotecan (Days 1 and 8, every 21 days) and area under the curve (AUC) 5 carboplatin (Day 1 every 21 days)
1194440|NCT00316121|B3|Baseline|Total|Total of all reporting groups
1194441|NCT00316121|B2|Baseline|Control|Autograft is bone taken from the subject’s own hip and placed in and around the spinal implant and spinal instrumentation. Local bone (bone from the area of surgery and placed in the fusion site) may be used in combination with autograft.
1194442|NCT00316121|B1|Baseline|HEALOS|"HEALOS is a synthetic bone graft material made of collagen (a fibrous protein) and hydroxyapatite (a natural mineral structure). The collagen is a bovine derivative (obtained from cows). HEALOS is similar to what is found in natural bone and has the clearance of the U.S. Food and Drug Administration for use in filling bony voids or gaps of the skeletal system. It is combined with bone marrow (a vascular or vessel-like tissue found in the cavity of bone) to form new bone. HEALOS with bone marrow aspirate is currently available for use in a procedure where rods and screws are placed in the back with graft material to fuse the vertebrae.~The Leopard cage is a spinal implant made of a material called carbon fiber. HEALOS, when used with the Leopard Cage is an investigational device. An investigational device is one that is being tested and has not yet received approval from the Food and Drug Administration for the use in which it is being tested."
1194443|NCT00316121|P2|Participant Flow|Control|Autograft is bone taken from the subject’s own hip and placed in and around the spinal implant and spinal instrumentation. Local bone (bone from the area of surgery and placed in the fusion site) may be used in combination with autograft.
1194444|NCT00316121|P1|Participant Flow|HEALOS|"HEALOS is a synthetic bone graft material made of collagen (a fibrous protein) and hydroxyapatite (a natural mineral structure). The collagen is a bovine derivative (obtained from cows). HEALOS is similar to what is found in natural bone and has the clearance of the U.S. Food and Drug Administration for use in filling bony voids or gaps of the skeletal system. It is combined with bone marrow (a vascular or vessel-like tissue found in the cavity of bone) to form new bone. HEALOS with bone marrow aspirate is currently available for use in a procedure where rods and screws are placed in the back with graft material to fuse the vertebrae.~The Leopard cage is a spinal implant made of a material called carbon fiber. HEALOS, when used with the Leopard Cage is an investigational device. An investigational device is one that is being tested and has not yet received approval from the Food and Drug Administration for the use in which it is being tested."
1194445|NCT00316121|O2|Outcome|Control|Autograft is bone taken from the subject’s own hip and placed in and around the spinal implant and spinal instrumentation. Local bone (bone from the area of surgery and placed in the fusion site) may be used in combination with autograft.
1194446|NCT00316121|O1|Outcome|HEALOS|"HEALOS is a synthetic bone graft material made of collagen (a fibrous protein) and hydroxyapatite (a natural mineral structure). The collagen is a bovine derivative (obtained from cows). HEALOS is similar to what is found in natural bone and has the clearance of the U.S. Food and Drug Administration for use in filling bony voids or gaps of the skeletal system. It is combined with bone marrow (a vascular or vessel-like tissue found in the cavity of bone) to form new bone. HEALOS with bone marrow aspirate is currently available for use in a procedure where rods and screws are placed in the back with graft material to fuse the vertebrae.~The Leopard cage is a spinal implant made of a material called carbon fiber. HEALOS, when used with the Leopard Cage is an investigational device. An investigational device is one that is being tested and has not yet received approval from the Food and Drug Administration for the use in which it is being tested."
1194447|NCT00316121|E2|Reported Event|Control|Autograft is bone taken from the subject’s own hip and placed in and around the spinal implant and spinal instrumentation. Local bone (bone from the area of surgery and placed in the fusion site) may be used in combination with autograft.
1194448|NCT00316121|E1|Reported Event|HEALOS|"HEALOS is a synthetic bone graft material made of collagen (a fibrous protein) and hydroxyapatite (a natural mineral structure). The collagen is a bovine derivative (obtained from cows). HEALOS is similar to what is found in natural bone and has the clearance of the U.S. Food and Drug Administration for use in filling bony voids or gaps of the skeletal system. It is combined with bone marrow (a vascular or vessel-like tissue found in the cavity of bone) to form new bone. HEALOS with bone marrow aspirate is currently available for use in a procedure where rods and screws are placed in the back with graft material to fuse the vertebrae.~The Leopard cage is a spinal implant made of a material called carbon fiber. HEALOS, when used with the Leopard Cage is an investigational device. An investigational device is one that is being tested and has not yet received approval from the Food and Drug Administration for the use in which it is being tested."
1194449|NCT00316082|B6|Baseline|Total|Total of all reporting groups
1194450|NCT00316082|B5|Baseline|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
1194451|NCT00316082|B4|Baseline|Saxagliptin 5 mg Once in the Evening (QPM)|The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
1194452|NCT00316082|B3|Baseline|Saxagliptin 2.5/5 mg QAM|The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
1194453|NCT00316082|B2|Baseline|Saxagliptin 5 mg QAM|The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
1194454|NCT00316082|B1|Baseline|Saxagliptin 2.5 mg Once in the Morning (QAM)|The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
1195063|NCT00314951|E2|Reported Event|Fidaxomicin|200 mg administered twice daily (q12hr)
1194456|NCT00316082|P4|Participant Flow|Saxagliptin 5 mg Once in the Evening (QPM)|The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
1194457|NCT00316082|P3|Participant Flow|Saxagliptin 2.5/5 mg QAM|The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
1199156|NCT00301262|O3|Outcome|DB Placebo Week 8|
1194459|NCT00316082|P1|Participant Flow|Saxagliptin 2.5 mg Once in the Morning (QAM)|The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
1194460|NCT00316082|O5|Outcome|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
1194461|NCT00316082|O4|Outcome|Saxagliptin 5 mg Once in the Evening (QPM)|The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
1194462|NCT00316082|O3|Outcome|Saxagliptin 2.5/5 mg QAM|The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
1194463|NCT00316082|O2|Outcome|Saxagliptin 5 mg QAM|The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
1194464|NCT00316082|O1|Outcome|Saxagliptin 2.5 mg Once in the Morning (QAM)|The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
1194465|NCT00316082|O5|Outcome|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
1194466|NCT00316082|O4|Outcome|Saxagliptin 5 mg Once in the Evening (QPM)|The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
1194467|NCT00316082|O3|Outcome|Saxagliptin 2.5/5 mg QAM|The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
1194468|NCT00316082|O2|Outcome|Saxagliptin 5 mg QAM|The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
1194469|NCT00316082|O1|Outcome|Saxagliptin 2.5 mg Once in the Morning (QAM)|The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
1194470|NCT00316082|O5|Outcome|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
1194471|NCT00316082|O4|Outcome|Saxagliptin 5 mg Once in the Evening (QPM)|The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
1194472|NCT00316082|O3|Outcome|Saxagliptin 2.5/5 mg QAM|The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
1194473|NCT00316082|O2|Outcome|Saxagliptin 5 mg QAM|The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
1194474|NCT00316082|O1|Outcome|Saxagliptin 2.5 mg Once in the Morning (QAM)|The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
1194475|NCT00316082|O2|Outcome|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
1194476|NCT00316082|O1|Outcome|Saxagliptin 5 mg QPM|The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
1194477|NCT00316082|O4|Outcome|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
1194478|NCT00316082|O3|Outcome|Saxagliptin 2.5/5 mg QAM|The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
1194479|NCT00316082|O2|Outcome|Saxagliptin 5 mg QAM|The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
1194480|NCT00316082|O1|Outcome|Saxagliptin 2.5 mg QAM|The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
1194481|NCT00316082|E5|Reported Event|Saxagliptin 5 mg QPM|The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
1194482|NCT00316082|E4|Reported Event|Saxagliptin 5 mg QAM|The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
1194483|NCT00316082|E3|Reported Event|Saxagliptin 2.5 mg QAM|The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
1194484|NCT00316082|E2|Reported Event|Saxagliptin 2.5/5 mg QAM|The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
1194485|NCT00316082|E1|Reported Event|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
1194486|NCT00316017|B4|Baseline|Total|Total of all reporting groups
1194487|NCT00316017|B3|Baseline|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
1194488|NCT00316017|B2|Baseline|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
1194489|NCT00316017|B1|Baseline|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
1194490|NCT00316017|P3|Participant Flow|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
1194491|NCT00316017|P2|Participant Flow|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
1195064|NCT00314951|E1|Reported Event|Vancomycin|125 mg administered 4 times daily (q6hr)
1194492|NCT00316017|P1|Participant Flow|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
1194493|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
1194494|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
1194495|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
1194496|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
1194497|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
1194507|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
1194508|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
1194509|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
1194510|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
1194511|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
1194512|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
1194513|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
1194514|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
1194515|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
1194516|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
1194517|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
1194518|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
1194519|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
1194520|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
1194521|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
1194522|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
1194523|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
1194524|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
1194525|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
1194526|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
1194527|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
1194528|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
1194529|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
1194530|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
1194531|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
1194532|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
1194533|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
1194534|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
1194535|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
1194536|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
1194537|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
1194538|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
1194539|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
1194540|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
1194541|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
1194542|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
1194543|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
1194544|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
1194545|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
1194546|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
1194547|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
1194548|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
1194549|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
1194550|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
1194551|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
1194552|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
1194553|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
1194554|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
1194555|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
1194556|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
1194557|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
1194558|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
1194559|NCT00316017|E3|Reported Event|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
1194560|NCT00316017|E2|Reported Event|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
1194561|NCT00316017|E1|Reported Event|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
1194562|NCT00316004|B4|Baseline|Total|Total of all reporting groups
1194563|NCT00316004|B3|Baseline|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194564|NCT00316004|B2|Baseline|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194565|NCT00316004|B1|Baseline|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194566|NCT00316004|P3|Participant Flow|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194567|NCT00316004|P2|Participant Flow|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194568|NCT00316004|P1|Participant Flow|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194569|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194570|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194571|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194572|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194573|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194574|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194575|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194576|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194577|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194578|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194579|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194580|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194581|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194582|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194583|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194584|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194585|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194586|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194587|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194588|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194589|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194590|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194591|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194592|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194621|NCT00315939|B2|Baseline|Experimental: Group B Order: IBMF-1, IBMF-2, SMBG|Group B will begin with level 2, followed by level 3 and then level 1. Each level will continue for 3 months.
1194593|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194594|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194595|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194596|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194597|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194598|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194599|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194600|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194601|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194602|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194603|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194604|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194605|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194606|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194607|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194608|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194609|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194610|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194611|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194612|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194613|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194614|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194615|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194616|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194617|NCT00316004|E3|Reported Event|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194618|NCT00316004|E2|Reported Event|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194619|NCT00316004|E1|Reported Event|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
1194620|NCT00315939|B3|Baseline|Total|Total of all reporting groups
1195622|NCT00313014|O1|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
1194622|NCT00315939|B1|Baseline|Experimental: Group A Order: SMBG, IBMF-1, IBMF-2|Group A will perform routine SMBG alone (level 1), followed sequentially by levels 2 and 3. Each level continued for 3 months.
1194623|NCT00315939|P2|Participant Flow|Experimental: Group B Order: IBMF-1, IBMF-2, SMBG|Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1) level 2 followed by IBMF-2, level 3 and then SMBG only. IBMF-1 (level 2) retained level 1, but an HHC (hand-held computer) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia, and glucose variability. The subjects were asked to carry the HHC and enter all their glucose readings when performing SMBG. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry. IBMF-2 (level 3) retained level 2, but the HHC asked subjects to provide symptom ratings when BG (blood glucose) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure.
1194624|NCT00315939|P1|Participant Flow|Experimental: Group A Order: SMBG, IBMF-1, IBMF-2|Self-monitored blood glucose (SMBG) alone (level 1), followed sequentially by Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1) level 2 and IBMF-2, level 3. IBMF-1 (level 2) retained level 1, but an HHC (hand-held computer) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia, and glucose variability. The subjects were asked to carry the HHC and enter all their glucose readings when performing SMBG. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry. IBMF-2 (level 3) retained level 2, but the HHC asked subjects to provide symptom ratings when BG (blood glucose) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure.
1194625|NCT00315939|O1|Outcome|Experimental Groups A and B|"Group A: SMBG alone (level 1), followed sequentially by levels 2 and 3. Group B: Level 2, followed by level 3 and then level 1.~Each level continued for 3 months.~IBMF-1 (level 2) retained level 1, but an HHC (hand-held computer) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia, and glucose variability. The subjects were asked to carry the HHC and enter all their glucose readings when performing SMBG. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry.~IBMF-2 (level 3) retained level 2, but the HHC asked subjects to provide symptom ratings when BG (blood glucose) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure."
1194626|NCT00315939|O1|Outcome|Experimental Groups A and B|"Group A: SMBG alone (level 1), followed sequentially by levels 2 and 3. Group B: Level 2, followed by level 3 and then level 1.~Each level continued for 3 months.~IBMF-1 (level 2) retained level 1, but an HHC (hand-held computer) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia, and glucose variability. The subjects were asked to carry the HHC and enter all their glucose readings when performing SMBG. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry.~IBMF-2 (level 3) retained level 2, but the HHC asked subjects to provide symptom ratings when BG (blood glucose) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure."
1194627|NCT00315939|E2|Reported Event|IBMF-2|IBMF-2 retains level 2, but the HHC asks subjects to provide symptom ratings when BG (blood glucose) is low and at an equal number of matching euglycemic readings. From these data, the HHC estimates a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure.
1194628|NCT00315939|E1|Reported Event|IBMF-1|IBMF-1 will use the OneTouch® UltraSmart® glucometer (LifeScan, Milpitas, CA) to collect routine SMBG data and the subject transfers the blood glucose (BG) value into a hand-held computer (HHC) for processing. As the subject checks BG on a daily basis, the IBMF-1 software calculates an estimate of HbA1c, acute risk for hypoglycemia and chronic risk for hypoglycemia. This information will be presented back to the subject. Specifically, (i) alarms for immediate action if BG<50 mg/dL is registered; (ii) a running HbA1c estimate (71); (iii) a warning to be more careful and measure BG more frequently over the next 24 hours if elevated acute risk for hypoglycemia is found, and (iv) an indication of the subject's chronic risk for hypoglycemia in one of 4 categories (minimal, low, moderate, and high). At moderate and high risk the subject will be prompted to consider altering his/her behavior. HbA1c and chronic risk change slowly (2-3 weeks), while acute risk can change daily.
1194629|NCT00315822|B3|Baseline|Total|Total of all reporting groups
1194630|NCT00315822|B2|Baseline|80% Oxygen|"Subject undergoing surgery will receive supplemental oxygen~80% oxygen: Supplemental oxygen will be administered during surgery"
1194631|NCT00315822|B1|Baseline|30% Oxygen|"Subjects undergoing surgery will receive routine administration of oxygen~30% oxygen: Subjects undergoing surgery will receive routine administration of oxygen"
1194632|NCT00315822|P2|Participant Flow|80% Oxygen|"Subject undergoing surgery will receive supplemental oxygen~80% oxygen: Supplemental oxygen will be administered during surgery"
1194633|NCT00315822|P1|Participant Flow|30% Oxygen|"Subjects undergoing surgery will receive routine administration of oxygen~30% oxygen: Subjects undergoing surgery will receive routine administration of oxygen"
1194634|NCT00315822|O2|Outcome|80% Oxygen|"Subject undergoing surgery will receive supplemental oxygen~80% oxygen: Supplemental oxygen will be administered during surgery"
1194635|NCT00315822|O1|Outcome|30% Oxygen|"Subjects undergoing surgery will receive routine administration of oxygen~30% oxygen: Subjects undergoing surgery will receive routine administration of oxygen"
1194636|NCT00315822|E2|Reported Event|80% Oxygen|"Subject undergoing surgery will receive supplemental oxygen~80% oxygen: Supplemental oxygen will be administered during surgery"
1194637|NCT00315822|E1|Reported Event|30% Oxygen|"Subjects undergoing surgery will receive routine administration of oxygen~30% oxygen: Subjects undergoing surgery will receive routine administration of oxygen"
1194758|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
1194638|NCT00315731|B1|Baseline|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
1194639|NCT00315731|P1|Participant Flow|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
1194640|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
1194641|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
1194642|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
1194643|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
1194644|NCT00315731|O2|Outcome|Tellurium-Derived Iodine I-131 Tositumomab|Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab Dosimetric dose (administered on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
1194645|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
1194749|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
1194646|NCT00315731|O2|Outcome|Tellurium-Derived Iodine I-131 Tositumomab|Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab Dosimetric dose (administered on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
1194671|NCT00315705|O1|Outcome|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously
1194672|NCT00315705|O1|Outcome|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously.
1194759|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
1194647|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
1194648|NCT00315731|O2|Outcome|Tellurium-Derived Iodine I-131 Tositumomab|Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab Dosimetric dose (administered on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
1194649|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
1194650|NCT00315731|O2|Outcome|Tellurium-Derived Iodine I-131 Tositumomab|Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab Dosimetric dose (administered on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
1194651|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
1194652|NCT00315731|O2|Outcome|Tellurium-Derived Iodine I-131 Tositumomab|Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab Dosimetric dose (administered on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
1194653|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
1194654|NCT00315731|O2|Outcome|Tellurium-Derived Iodine I-131 Tositumomab|Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab Dosimetric dose (administered on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
1194667|NCT00315705|P1|Participant Flow|Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2. > Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously
1194655|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
1194760|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
1194656|NCT00315731|O2|Outcome|Tellurium-Derived Iodine I-131 Tositumomab|Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
1194657|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
1194658|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
1194659|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
1194660|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
1194661|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
1194662|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
1194663|NCT00315731|E1|Reported Event|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
1194664|NCT00315705|B3|Baseline|Total|Total of all reporting groups
1194665|NCT00315705|B2|Baseline|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously
1194666|NCT00315705|B1|Baseline|Phase 1: Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2.
1194668|NCT00315705|O1|Outcome|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously
1195027|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
1194669|NCT00315705|O1|Outcome|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously.
1194670|NCT00315705|O1|Outcome|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously
1194755|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
1194673|NCT00315705|O1|Outcome|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously
1194674|NCT00315705|O1|Outcome|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously
1194675|NCT00315705|O1|Outcome|Phase 1: Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2.
1194676|NCT00315705|O1|Outcome|Phase 1: Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2.
1194677|NCT00315705|O1|Outcome|Phase 1: Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2.
1194678|NCT00315705|O1|Outcome|Phase 1: Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2.
1194679|NCT00315705|O1|Outcome|Phase 1: Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2.
1194680|NCT00315705|O1|Outcome|Phase 1: Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2.
1194681|NCT00315705|O5|Outcome|Phase 1 - Cohort 5|Participants were treated with clofarabine 40 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
1194682|NCT00315705|O4|Outcome|Phase 1 - Cohort 4|Participants were treated with clofarabine 30 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
1194683|NCT00315705|O3|Outcome|Phase 1 - Cohort 3|Participants were treated with clofarabine 20 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
1194684|NCT00315705|O2|Outcome|Phase 1 - Cohort 2|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 440 mg/m^2.
1194685|NCT00315705|O1|Outcome|Phase 1 - Cohort 1|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 340 mg/m^2.
1194686|NCT00315705|O5|Outcome|Phase 1 - Cohort 5|Participants were treated with clofarabine 40 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
1194687|NCT00315705|O4|Outcome|Phase 1 - Cohort 4|Participants were treated with clofarabine 30 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
1194688|NCT00315705|O3|Outcome|Phase 1 - Cohort 3|Participants were treated with clofarabine 20 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
1194689|NCT00315705|O2|Outcome|Phase 1 - Cohort 2|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 440 mg/m^2.
1194690|NCT00315705|O1|Outcome|Phase 1 - Cohort 1|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 340 mg/m^2.
1194691|NCT00315705|O5|Outcome|Phase 1 - Cohort 5|Participants were treated with clofarabine 40 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
1194692|NCT00315705|O4|Outcome|Phase 1 - Cohort 4|Participants were treated with clofarabine 30 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
1194693|NCT00315705|O3|Outcome|Phase 1 - Cohort 3|Participants were treated with clofarabine 20 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
1194694|NCT00315705|O2|Outcome|Phase 1 - Cohort 2|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 440 mg/m^2.
1194695|NCT00315705|O1|Outcome|Phase 1 - Cohort 1|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 340 mg/m^2.
1194696|NCT00315705|E7|Reported Event|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously.
1194697|NCT00315705|E6|Reported Event|Phase 1 - Total|All participants from Cohorts 1-5 in Phase 1
1194698|NCT00315705|E5|Reported Event|Phase 1 - Cohort 5|Participants were treated with clofarabine 40 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
1194699|NCT00315705|E4|Reported Event|Phase 1 - Cohort 4|Participants were treated with clofarabine 30 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
1194700|NCT00315705|E3|Reported Event|Phase 1 - Cohort 3|Participants were treated with clofarabine 20 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
1194701|NCT00315705|E2|Reported Event|Phase 1 - Cohort 2|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 440 mg/m^2.
1194702|NCT00315705|E1|Reported Event|Phase 1 - Cohort 1|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 340 mg/m^2.
1194703|NCT00315627|B1|Baseline|Islet Transplantation|Islet transplantation: Islet transplantation
1194704|NCT00315627|P1|Participant Flow|Islet Transplantation|Single arm study. Subjects with Type 1 Diabetes, severe hypoglycemia and hypoglycemia unawareness received intrahepatic islet transplantation (1 or 2 infusions) under alemtuzumab induction and rapamycin + MMF maintenance immunosuppression.
1194705|NCT00315627|O1|Outcome|Islet Transplantation|Single arm study. Subjects with Type 1 Diabetes, severe hypoglycemia and hypoglycemia unawareness received intrahepatic islet transplantation (1 or 2 infusions) under alemtuzumab induction and rapamycin + MMF maintenance immunosuppression.
1194706|NCT00315627|O1|Outcome|Islet Transplantation|"Islet Alone Transplantation under Alentuzumab (Campath1H) induction.~Islet transplantation: Islet transplantation"
1194707|NCT00315627|O1|Outcome|Islet Transplantation|Islet Alone Transplantation under Alentuzumab (Campath1H) induction.
1194708|NCT00315627|O1|Outcome|Islet Transplantation|Islet Alone Transplantation under Alentuzumab (Campath1H) induction.
1194756|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
1194757|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
1194709|NCT00315627|O1|Outcome|Islet Transplantation|Single arm study. Subjects with Type 1 Diabetes, severe hypoglycemia and hypoglycemia unawareness received intrahepatic islet transplantation (1 or 2 infusions) under alemtuzumab induction and rapamycin + MMF maintenance immunosuppression.
1194710|NCT00315627|E1|Reported Event|Islet Transplantation|Islet transplantation alone under alentuzumab (Campath1H) induction.
1194711|NCT00315614|B1|Baseline|Islet Transplantation and CD34 Bone Marrow|Islet Transplantation: Islet transplantation
1194712|NCT00315614|P1|Participant Flow|Islet Transplantation and Bone Marrow|Islet transplantation and CD34 Bone Marrow infusion in subjects with type 1 diabetes, impaired hypoglycemia awareness and severe hypoglycemia.
1194713|NCT00315614|O1|Outcome|Islet Transplantation and Bone Marrow|Islet transplantation and CD34 Bone Marrow infusion in subjects with type 1 diabetes, impaired hypoglycemia awareness and severe hypoglycemia.
1194714|NCT00315614|O1|Outcome|Islet Transplantation and Bone Marrow|Islet transplantation and CD34 Bone Marrow infusion in subjects with type 1 diabetes, impaired hypoglycemia awareness and severe hypoglycemia.
1194715|NCT00315614|O1|Outcome|Islet Transplantation and Bone Marrow|Islet transplantation and CD34 Bone Marrow infusion in subjects with type 1 diabetes, impaired hypoglycemia awareness and severe hypoglycemia.
1194716|NCT00315614|O1|Outcome|Islet Transplantation and CD34 Bone Marrow|Islet Transplantation: Islet transplantation
1194717|NCT00315614|E1|Reported Event|Islet Transplantation and CD34 Bone Marrow|Islet Transplantation: Islet transplantation
1194718|NCT00315588|B1|Baseline|Islet Transplantation|Islet transplantation in subjects with previous kidney transplant
1194719|NCT00315588|P1|Participant Flow|Islet Transplantation|Islet transplantation in subjects with previous kidney transplant.
1194720|NCT00315588|O1|Outcome|Islet Transplantation|Islet transplantation in subjects with a previous kidney transplant
1194721|NCT00315588|O1|Outcome|Islet Transplantation|Islet transplantation in subjects with previous kidney transplant.
1194722|NCT00315588|O1|Outcome|Islet Transplantation|Islet transplantation in subjects with a previous kidney transplant.
1194723|NCT00315588|O1|Outcome|Islet Transplantation|Islet transplantation in subjects with previous kidney transplant.
1194724|NCT00315588|E1|Reported Event|Islet Transplantation|Islet transplantation in subjects with previous kidney transplant
1194725|NCT00315458|B3|Baseline|Total|Total of all reporting groups
1194726|NCT00315458|B2|Baseline|Double-blind BTDS|Test treatments buprenorphine transdermal patch (BTDS) 10 or BTDS 20 applied for 7-day wear
1194727|NCT00315458|B1|Baseline|Double-blind Placebo Patch|Reference Treatment placebo 10 or 20 applied for 7-day wear
1194728|NCT00315458|P4|Participant Flow|Extension Phase BTDS 5/10/20|Subjects who finished the entire 12-week (84-day) double-blind phase were eligible to participate in the open-label extension phase. Subjects began treatment with BTDS 5 and their doses were titrated to BTDS 10 or BTDS 20 as needed.
1194729|NCT00315458|P3|Participant Flow|Run-in Period BTDS 5/10/20|All subjects were started on BTDS 5 and titrated to BTDS 10 and 20. Subjects who met the protocol-specified criteria for adequate analgesia were eligible for entry into the double-blind phase. Subjects who could not tolerate at least BTDS 10 were discontinued from the study.
1194730|NCT00315458|P2|Participant Flow|Double-blind BTDS 10/20|Test treatments buprenorphine transdermal patch (BTDS) 10 or BTDS 20 applied for 7-day wear
1194731|NCT00315458|P1|Participant Flow|Double-blind Placebo Patch|Reference Treatment placebo 10 or 20 applied for 7-day wear
1194732|NCT00315458|O4|Outcome|Overall BTDS Exposure|Total number of subjects exposed to BTDS for overall study which includes the core study and extension phase.
1194733|NCT00315458|O3|Outcome|Run-in Period|All subjects were started on BTDS 5 and titrated to BTDS 10 and 20. Subjects who met the protocol-specified criteria for adequate analgesia were eligible for entry into the double-blind phase. Subjects who could not tolerate at least BTDS 10 were discontinued from the study.
1194734|NCT00315458|O2|Outcome|Double-blind BTDS|Test treatment buprenoprhine transdermal patch (BTDS) 10 or BTDS 20 applied for 7-day wear
1194735|NCT00315458|O1|Outcome|Double-blind Placebo|Reference treatment placebo 10 or 20 applied for 7-day wear
1194736|NCT00315458|E4|Reported Event|Overall BTDS Exposure|Total number of subjects exposed to BTDS for overall study which includes the core study and extension phase.
1194737|NCT00315458|E3|Reported Event|Run-in Period|Open-label Run-in period (BTDS 5, 10, or 20) applied for 7-day wear
1194738|NCT00315458|E2|Reported Event|Double-blind BTDS 10/20|Test treatment buprenorphine transdermal patch (BTDS) 10 or BTDS 20 applied for 7-day wear
1194739|NCT00315458|E1|Reported Event|Double-blind Placebo Patch|Reference Treatment placebo 10 or 20 applied for 7-day wear
1194740|NCT00315445|B4|Baseline|Total|Total of all reporting groups
1194741|NCT00315445|B3|Baseline|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
1194742|NCT00315445|B2|Baseline|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
1194743|NCT00315445|B1|Baseline|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
1194744|NCT00315445|P3|Participant Flow|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
1194745|NCT00315445|P2|Participant Flow|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
1194746|NCT00315445|P1|Participant Flow|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
1194747|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
1194748|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
1194750|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
1194751|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
1194752|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
1194753|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
1194754|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
1194761|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
1194762|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
1194763|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
1194764|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
1194765|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
1194766|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
1194767|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
1194768|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
1194769|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
1194770|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
1194771|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
1194772|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
1194773|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
1194774|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
1194775|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
1194776|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
1194777|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
1194778|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
1194779|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
1194780|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
1194781|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
1194782|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
1194783|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
1194784|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
1194785|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
1194786|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
1194787|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
1194788|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
1194789|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
1194790|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
1194791|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
1194792|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
1194793|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
1194794|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
1194795|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
1194796|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
1194797|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
1194798|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
1194799|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
1194800|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
1194801|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
1194802|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
1194803|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
1194804|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
1194805|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
1194806|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
1194807|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
1194808|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
1195625|NCT00313014|O1|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
1194809|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
1194810|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
1194811|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
1194812|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
1194813|NCT00315445|E3|Reported Event|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
1194814|NCT00315445|E2|Reported Event|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
1194815|NCT00315445|E1|Reported Event|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
1194816|NCT00315341|B3|Baseline|Total|Total of all reporting groups
1194817|NCT00315341|B2|Baseline|Methadone|
1194818|NCT00315341|B1|Baseline|Buprenorphine/Nx|
1194819|NCT00315341|P2|Participant Flow|Methadone|The mean dose of methadone was 93.2 mg.
1194820|NCT00315341|P1|Participant Flow|Buprenorphine/Nx|Participants received medication for 24 weeks in the active phase of the study. The mean dose of buprenorphine was 22.3 mg. Blood samples for measurement of liver function were taken at baseline and at Weeks 1, 2, 4 8, 12, 16, 20, and 24 with follow-up at Week 32.
1194821|NCT00315341|O2|Outcome|Methadone|
1194822|NCT00315341|O1|Outcome|Buprenorphine/Nx|
1194823|NCT00315341|E2|Reported Event|Methadone|For the MET group, all participants will receive a maximum of 30 mg for the first dose and a maximum of 40 mg on Day 1. It is recommended that participants receive a dose on day 2 that is 10 mg higher than their total day 1 dose, and a dose on day 3 that is 10 mg higher than their total day 2 dose, unless, in the clinical judgment of the physician, a slower induction is needed. Doses will be adjusted on Day 4 and thereafter according to clinical impression and depending upon the participant’s clinical need with no specific upper limit. Investigators are encouraged to dose adequately to decrease craving and to obtain negative urine toxicology specimens.
1194824|NCT00315341|E1|Reported Event|Buprenorphine/Nx|For the BUP/NX group, all participants will receive up to 16 mg BUP/4 mg NX on day 1 and up to 32 mg BUP/8 mg NX on day 2. It is recommended that dose changes be made in 2 to 8 mg buprenorphine increments, with the range of allowable daily doses between 2 mg and 32 mg starting on day 3 and thereafter according to clinical impression and depending upon the participant’s clinical need. Investigators are encouraged to dose adequately to decrease craving and to obtain negative urine toxicology specimens.
1194825|NCT00315328|B5|Baseline|Total|Total of all reporting groups
1194826|NCT00315328|B4|Baseline|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
1194827|NCT00315328|B3|Baseline|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
1194828|NCT00315328|B2|Baseline|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
1194829|NCT00315328|B1|Baseline|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
1194830|NCT00315328|P4|Participant Flow|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
1194831|NCT00315328|P3|Participant Flow|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
1194832|NCT00315328|P2|Participant Flow|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
1194833|NCT00315328|P1|Participant Flow|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
1194834|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
1194835|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
1194836|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
1194837|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
1195028|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
1194838|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
1194839|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
1194840|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
1194841|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
1194842|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
1194843|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
1194844|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
1194845|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
1194846|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
1194847|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
1194848|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
1194849|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
1194850|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
1194851|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
1194852|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
1194853|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
1194854|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
1194855|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
1194856|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
1194857|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
1194858|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
1194859|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
1194860|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
1194861|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
1194862|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
1194863|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
1194864|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
1194865|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
1194866|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
1194867|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
1194868|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
1194869|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
1194870|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
1194871|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
1195606|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
1194872|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
1194873|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
1194874|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
1194875|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
1194876|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
1194877|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
1194878|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
1194879|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
1194880|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
1194881|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
1194882|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
1194883|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
1194884|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
1194885|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
1194886|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
1194887|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
1194888|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
1194889|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
1194890|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
1194891|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
1194892|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
1194893|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
1194894|NCT00315328|E4|Reported Event|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
1194895|NCT00315328|E3|Reported Event|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
1194896|NCT00315328|E2|Reported Event|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
1194897|NCT00315328|E1|Reported Event|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
1194898|NCT00315302|B5|Baseline|Total|Total of all reporting groups
1194899|NCT00315302|B4|Baseline|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
1194900|NCT00315302|B3|Baseline|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
1194901|NCT00315302|B2|Baseline|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
1194902|NCT00315302|B1|Baseline|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
1194903|NCT00315302|P4|Participant Flow|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
1194904|NCT00315302|P3|Participant Flow|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
1194905|NCT00315302|P2|Participant Flow|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
1194906|NCT00315302|P1|Participant Flow|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
1195607|NCT00313144|O1|Outcome|Baseline|
1195608|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
1194907|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
1194908|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
1194909|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
1194910|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
1194911|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
1194912|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
1194913|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
1195774|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
1194914|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
1194915|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
1194916|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
1194917|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
1194918|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
1194919|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
1194920|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
1194921|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
1194922|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
1194923|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
1194924|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
1194925|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
1194926|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
1194927|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
1194928|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
1194929|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
1194930|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
1194931|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
1194932|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
1194933|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
1194934|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
1194935|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
1194936|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
1194937|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
1194938|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
1194939|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
1194940|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
1194941|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
1194942|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
1194943|NCT00315302|E4|Reported Event|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
1195609|NCT00313144|O1|Outcome|Baseline|
1194944|NCT00315302|E3|Reported Event|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
1194945|NCT00315302|E2|Reported Event|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
1194946|NCT00315302|E1|Reported Event|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
1194947|NCT00315146|B5|Baseline|Total|Total of all reporting groups
1194956|NCT00315146|O4|Outcome|Hypocaloric Diet,Resistance Training, Pioglitazone/Actos™|"Pioglitazone~Resistance exercise training to maximize muscle power~Hypocaloric diet"
1194957|NCT00315146|O3|Outcome|Hypocaloric Diet and a PPAR- γ Agonist (Pioglitazone/Actos™)|"Pioglitazone~Hypocaloric diet"
1194958|NCT00315146|O2|Outcome|Hypocaloric Diet, Resist. Training to Maximize Power, Placebo|"Resistance exercise training to maximize muscle power~Hypocaloric diet~Placebo"
1194959|NCT00315146|O1|Outcome|Hypocaloric Diet (and Placebo)|"Hypocaloric diet~Placebo"
1195344|NCT00313716|O1|Outcome|TT7 Group|Patients had hemoglobin concentration maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
1194948|NCT00315146|B4|Baseline|Hypocaloric Weight Loss + Resistance Training + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants.~The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body.~Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone."
1194949|NCT00315146|B3|Baseline|Hypocaloric Weight-loss +Resistance Training|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.~The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body. Training sessions ended with a cool-down session of light stretching."
1194950|NCT00315146|B2|Baseline|Hypocaloric Weight Loss + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.~Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks, but none were reported. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone. In order to understand the potential effects of changes in body composition independent of drug effects, a 1-week wash-out period preceded the follow-up outcome assessment."
1194951|NCT00315146|B1|Baseline|Hypocaloric Weight Loss Only|Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day. The macronutrient goal for each individual was ~55-60% carbohydrates, ~15% protein, and ~25% fat.
1194952|NCT00315146|P4|Participant Flow|Hypocaloric Weight Loss + Resistance Training + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants.~The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body.~Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone."
1194953|NCT00315146|P3|Participant Flow|Hypocaloric Weight-loss +Resistance Training|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.~The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body. Training sessions ended with a cool-down session of light stretching."
1194954|NCT00315146|P2|Participant Flow|Hypocaloric Weight Loss + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.~Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks, but none were reported. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone. In order to understand the potential effects of changes in body composition independent of drug effects, a 1-week wash-out period preceded the follow-up outcome assessment."
1195029|NCT00315120|E4|Reported Event|Sham OMT + Sham UST|Sham osteopathic manipulation and sham ultrasound therapy
1195610|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
1194955|NCT00315146|P1|Participant Flow|Hypocaloric Weight Loss Only|Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day. The macronutrient goal for each individual was ~55-60% carbohydrates, ~15% protein, and ~25% fat.
1194960|NCT00315146|O4|Outcome|Hypocaloric Weight Loss + Resistance Training + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants.~The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body.~Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone."
1194961|NCT00315146|O3|Outcome|Hypocaloric Weight-loss +Resistance Training|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.~The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body. Training sessions ended with a cool-down session of light stretching."
1194962|NCT00315146|O2|Outcome|Hypocaloric Weight Loss + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.~Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks, but none were reported. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone. In order to understand the potential effects of changes in body composition independent of drug effects, a 1-week wash-out period preceded the follow-up outcome assessment."
1194963|NCT00315146|O1|Outcome|Hypocaloric Weight Loss Only|Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day. The macronutrient goal for each individual was ~55-60% carbohydrates, ~15% protein, and ~25% fat.
1194964|NCT00315146|E4|Reported Event|Hypocaloric Weight Loss + Resistance Training + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants.~The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body.~Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone."
1194965|NCT00315146|E3|Reported Event|Hypocaloric Weight-loss +Resistance Training|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.~The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body. Training sessions ended with a cool-down session of light stretching."
1195030|NCT00315120|E3|Reported Event|OMT + Sham UST|Active osteopathic manipulation and sham ultrasound therapy
1195031|NCT00315120|E2|Reported Event|Sham OMT + UST|Sham osteopathic manipulation and active ultrasound therapy
1195032|NCT00315120|E1|Reported Event|OMT + UST|Active osteopathic manipulation and active ultrasound therapy
1195033|NCT00315055|B3|Baseline|Total|Total of all reporting groups
1195611|NCT00313144|O1|Outcome|Baseline|
1195612|NCT00313144|E1|Reported Event|Overall Study|
1194966|NCT00315146|E2|Reported Event|Hypocaloric Weight Loss + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.~Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks, but none were reported. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone. In order to understand the potential effects of changes in body composition independent of drug effects, a 1-week wash-out period preceded the follow-up outcome assessment."
1195069|NCT00314808|O1|Outcome|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
1199157|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
1194967|NCT00315146|E1|Reported Event|Hypocaloric Weight Loss Only|Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day. The macronutrient goal for each individual was ~55-60% carbohydrates, ~15% protein, and ~25% fat.
1194968|NCT00315120|B5|Baseline|Total|Total of all reporting groups
1194969|NCT00315120|B4|Baseline|Sham OMT + Sham UST|Sham osteopathic manipulation and sham ultrasound physical therapy
1194970|NCT00315120|B3|Baseline|OMT + Sham UST|Active osteopathic manipulation and sham ultrasound physical therapy
1194971|NCT00315120|B2|Baseline|Sham OMT + UST|Sham osteopathic manipulation and active ultrasound physical therapy
1194972|NCT00315120|B1|Baseline|OMT + UST|Active osteopathic manipulation and active ultrasound physical therapy
1194973|NCT00315120|P4|Participant Flow|Sham OMT + Sham UST|Sham osteopathic manipulation and sham ultrasound physical therapy
1194974|NCT00315120|P3|Participant Flow|OMT + Sham UST|Active osteopathic manipulation and sham ultrasound physical therapy
1194975|NCT00315120|P2|Participant Flow|Sham OMT + UST|Sham osteopathic manipulation and active ultrasound physical therapy
1194976|NCT00315120|P1|Participant Flow|OMT + UST|Active osteopathic manipulation and active ultrasound physical therapy
1194977|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
1194978|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
1194979|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
1194980|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
1194981|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
1194982|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
1194983|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
1194984|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
1194985|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
1194986|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
1194987|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
1194988|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
1194989|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
1194990|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
1194991|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
1194992|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
1194993|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
1194994|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
1194995|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
1194996|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
1194997|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
1194998|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
1194999|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
1195000|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
1195001|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
1195002|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
1195003|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
1195004|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
1195005|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
1195006|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
1195007|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
1195008|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
1195009|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
1195010|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
1195011|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
1195012|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
1195013|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
1195014|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
1195015|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
1195016|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
1195017|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound therapy
1195018|NCT00315120|O1|Outcome|Active UST|Active ultrasound therapy
1195019|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
1195020|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
1195021|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
1195022|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
1195023|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
1195024|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
1195025|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
1195026|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
1195034|NCT00315055|B2|Baseline|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
1195035|NCT00315055|B1|Baseline|DTaP-IPV-Hep B-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
1195036|NCT00315055|P2|Participant Flow|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
1195037|NCT00315055|P1|Participant Flow|DTaP-IPV-Hep B-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
1195038|NCT00315055|O2|Outcome|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
1195039|NCT00315055|O1|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
1195040|NCT00315055|O2|Outcome|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP IPV PRP T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX®) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
1195041|NCT00315055|O1|Outcome|DTaP-IPV-HB-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP IPV Hep B PRP T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
1195042|NCT00315055|O2|Outcome|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP IPV PRP T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX®) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
1195043|NCT00315055|O1|Outcome|DTaP-IPV-HB-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP IPV Hep B PRP T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
1195044|NCT00315055|O2|Outcome|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
1195045|NCT00315055|O1|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
1195046|NCT00315055|O2|Outcome|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
1195047|NCT00315055|O1|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
1195048|NCT00315055|O2|Outcome|PENTAXIM™ and ENGERIX® PEDIATRIC|Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
1195049|NCT00315055|O1|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
1195050|NCT00315055|E2|Reported Event|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
1195051|NCT00315055|E1|Reported Event|DTaP-IPV-Hep B-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
1195052|NCT00314951|B3|Baseline|Total|Total of all reporting groups
1195053|NCT00314951|B2|Baseline|Fidaxomicin|200 mg administered twice daily (q12hr)
1195054|NCT00314951|B1|Baseline|Vancomycin|125 mg administered 4 times daily (q6hr)
1195055|NCT00314951|P2|Participant Flow|Fidaxomicin|200 mg administered twice daily (q12hr)
1195056|NCT00314951|P1|Participant Flow|Vancomycin|125 mg administered 4 times daily (q6hr)
1195057|NCT00314951|O2|Outcome|Fidaxomicin|200 mg administered twice daily (q12hr)
1195058|NCT00314951|O1|Outcome|Vancomycin|125 mg administered 4 times daily (q6hr)
1195059|NCT00314951|O2|Outcome|Fidaxomicin|200 mg administered twice daily (q12hr)
1195060|NCT00314951|O1|Outcome|Vancomycin|125 mg administered 4 times daily (q6hr)
1195061|NCT00314951|O2|Outcome|Fidaxomicin|200 mg administered twice daily (q12hr)
1195062|NCT00314951|O1|Outcome|Vancomycin|125 mg administered 4 times daily (q6hr)
1195613|NCT00313014|B4|Baseline|Total|Total of all reporting groups
1195065|NCT00314808|B1|Baseline|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
1195066|NCT00314808|P1|Participant Flow|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
1195067|NCT00314808|O1|Outcome|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
1195068|NCT00314808|O1|Outcome|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
1199158|NCT00301262|O1|Outcome|DB Viagra Week 8|
1195070|NCT00314808|O1|Outcome|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
1195071|NCT00314808|O1|Outcome|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
1195072|NCT00314808|E1|Reported Event|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
1195073|NCT00314574|B3|Baseline|Total|Total of all reporting groups
1195074|NCT00314574|B2|Baseline|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
1195075|NCT00314574|B1|Baseline|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
1195076|NCT00314574|P2|Participant Flow|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
1195077|NCT00314574|P1|Participant Flow|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
1195078|NCT00314574|O2|Outcome|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
1195079|NCT00314574|O1|Outcome|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
1195080|NCT00314574|O2|Outcome|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
1195081|NCT00314574|O1|Outcome|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
1195082|NCT00314574|O2|Outcome|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
1195083|NCT00314574|O1|Outcome|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
1195235|NCT00313846|P2|Participant Flow|Double-blind BTDS|Test treatment in the double-blind phase. Buprenorphine transdermal patches 5, 10, or 20 applied for 7-day wear.
1195084|NCT00314574|O2|Outcome|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
1195085|NCT00314574|O1|Outcome|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
1195086|NCT00314574|O2|Outcome|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
1195087|NCT00314574|O1|Outcome|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
1195088|NCT00314574|E2|Reported Event|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
1195089|NCT00314574|E1|Reported Event|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
1195090|NCT00314366|B3|Baseline|Total|Total of all reporting groups
1195091|NCT00314366|B2|Baseline|Control|"Control (Placebo) patients will receive injections of plasma control instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
1195092|NCT00314366|B1|Baseline|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
1195093|NCT00314366|P2|Participant Flow|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
1195094|NCT00314366|P1|Participant Flow|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
1195095|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
1195096|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
1195097|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
1195098|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
1195099|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
1195100|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
1195236|NCT00313846|P1|Participant Flow|Double-blind Placebo|Reference treatment in the double-blind phase. Placebo transdermal patches matched the BTDS patches applied for 7-day wear.
1195101|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
1195102|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
1195125|NCT00314353|P1|Participant Flow|Capecitabine, Oxaliplatin, Bevacizumab|
1195126|NCT00314353|O2|Outcome|Capecitabine, Irinotecan, Bevacizumab|
1195127|NCT00314353|O1|Outcome|Capecitabine, Oxaliplatin, Bevacizumab|
1195128|NCT00314353|E2|Reported Event|Capecitabine, Irinotecan, Bevacizumab|
1195103|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
1195104|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
1195105|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
1195106|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
1195107|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
1195108|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
1195109|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
1195110|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
1195111|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
1195112|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
1195113|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~At 6 months, subject is offered stem cell therapy and then followed for 12 months.~Control (plasma): Placebo patients receive an injection of plasma (control) containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
1195114|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
1195115|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
1195116|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
1195117|NCT00314366|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
1195118|NCT00314366|O1|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~At 6 months, subject is offered stem cell therapy and then followed for 12 months.~Control (plasma): Placebo patients receive an injection of plasma (control) containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
1195119|NCT00314366|E2|Reported Event|Control|"Placebo (control) patients will receive injections of plasma control instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
1195616|NCT00313014|B1|Baseline|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
1195120|NCT00314366|E1|Reported Event|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
1195121|NCT00314353|B3|Baseline|Total|Total of all reporting groups
1195122|NCT00314353|B2|Baseline|Capecitabine, Irinotecan, Bevacizumab|
1195123|NCT00314353|B1|Baseline|Capecitabine, Oxaliplatin, Bevacizumab|
1195124|NCT00314353|P2|Participant Flow|Capecitabine, Irinotecan, Bevacizumab|
1195130|NCT00314340|B1|Baseline|Prescription Opioid Abusers|The subjective effects of the study drug were evaluated with the short form of the Addiction Research Center Inventory (ARCI. This inventory consists of 49 true/ false questions which survey major domains of drug effects. Participants indicated the pleasurable effects or desirability of the medications on 4 locally developed drug-liking ratings: craving, liking, strong desire, and “want more pain medication.” Ratings were made on a 100-mm VAS anchored with 0 at the low end and 10 at the high end. Participants also responded to 11 locally developed drug-effect ratings to assess psychoactive effects. Ratings were again made on a 100-mmVAS anchoredwith 0 at the lowend and 10 at the high end for:“on cloud 9,” “high,” “good drug effect,” “bad drug effect,” “impaired,”“stoned,” “sedated,” “confused,” “nauseated from,” “anxious,” and “down”. The rating levels over a six hour period were examined to explore the timing of these effects.
1195131|NCT00314340|P1|Participant Flow|All Participants|All participants were randomized to receive the ER morphine tablets, 45 mg, hydrocodone 30 mg plus N-acetyl-para-aminophenol 975 mg, or placebo in a 3 way cross over design.
1195132|NCT00314340|O3|Outcome|Placebo|
1195133|NCT00314340|O2|Outcome|Hydrocodone 30 mg Plus N-acetyl-para-aminophenol 975 mg|These findings all argue against the hypothesis that the hydrocodone product induced a greater euphoric or reinforcing effect than that of ER morphine.
1195134|NCT00314340|O1|Outcome|ER Morphine Tablets, 45mg|Scores of the 5 Addiction Research Center Inventory dimensions did not change significantly between baseline and 300 min under any treatment condition.
1195135|NCT00314340|E1|Reported Event|Prescription Opioid Abusers|The subjective effects of the study drug were evaluated with the short form of the Addiction Research Center Inventory (ARCI. This inventory consists of 49 true/ false questions which survey major domains of drug effects. Participants indicated the pleasurable effects or desirability of the medications on 4 locally developed drug-liking ratings: craving, liking, strong desire, and “want more pain medication.” Ratings were made on a 100-mm VAS anchored with 0 at the low end and 10 at the high end. Participants also responded to 11 locally developed drug-effect ratings to assess psychoactive effects. Ratings were again made on a 100-mmVAS anchoredwith 0 at the lowend and 10 at the high end for:“on cloud 9,” “high,” “good drug effect,” “bad drug effect,” “impaired,”“stoned,” “sedated,” “confused,” “nauseated from,” “anxious,” and “down”. The rating levels over a six hour period were examined to explore the timing of these effects.
1195136|NCT00314327|B1|Baseline|Long-acting Injectable Risperidone|"One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.~long-acting injectable risperidone: One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection."
1195137|NCT00314327|P1|Participant Flow|Long-acting Injectable Risperidone|"One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.~long-acting injectable risperidone: One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection."
1195138|NCT00314327|O1|Outcome|Long-acting Injectable Risperidone|"One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.~long-acting injectable risperidone: One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection."
1195139|NCT00314327|E1|Reported Event|Long-acting Injectable Risperidone|"One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.~long-acting injectable risperidone: One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection."
1195140|NCT00314262|B1|Baseline|Erlotinib & Celecoxib|"Erlotinib & Celecoxib: Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.~Celecoxib given 400 mg orally BID continuously for 6 months."
1197008|NCT00308074|O1|Outcome|Aripiprazole|aripiprazole monotherapy
1195141|NCT00314262|P1|Participant Flow|Erlotinib & Celecoxib|"Erlotinib & Celecoxib: Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.~Celecoxib given 400 mg orally BID continuously for 6 months."
1195142|NCT00314262|O1|Outcome|Erlotinib & Celecoxib|"Erlotinib & Celecoxib: Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.~Celecoxib given 400 mg orally BID continuously for 6 months."
1195143|NCT00314262|O1|Outcome|Erlotinib & Celecoxib|"Erlotinib & Celecoxib: Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.~Celecoxib given 400 mg orally BID continuously for 6 months."
1195144|NCT00314262|O1|Outcome|Erlotinib & Celecoxib|"Erlotinib & Celecoxib: Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.~Celecoxib given 400 mg orally BID continuously for 6 months."
1199159|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
1195145|NCT00314262|E1|Reported Event|Erlotinib & Celecoxib|"Erlotinib & Celecoxib: Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.~Celecoxib given 400 mg orally BID continuously for 6 months."
1195146|NCT00314249|B3|Baseline|Total|Total of all reporting groups
1195147|NCT00314249|B2|Baseline|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
1195148|NCT00314249|B1|Baseline|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
1195149|NCT00314249|P2|Participant Flow|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
1195150|NCT00314249|P1|Participant Flow|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
1195151|NCT00314249|O2|Outcome|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
1195152|NCT00314249|O1|Outcome|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
1195153|NCT00314249|O2|Outcome|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
1195154|NCT00314249|O1|Outcome|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
1195155|NCT00314249|O2|Outcome|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
1195156|NCT00314249|O1|Outcome|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
1195157|NCT00314249|O2|Outcome|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
1195158|NCT00314249|O1|Outcome|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
1195159|NCT00314249|O2|Outcome|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
1195160|NCT00314249|O1|Outcome|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
1195161|NCT00314249|O2|Outcome|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
1195162|NCT00314249|O1|Outcome|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
1195163|NCT00314249|E2|Reported Event|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
1195164|NCT00314249|E1|Reported Event|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
1195165|NCT00314236|B3|Baseline|Total|Total of all reporting groups
1195166|NCT00314236|B2|Baseline|Control|Microfracture alone
1195167|NCT00314236|B1|Baseline|Experimental|BST-CarGel applied to a Microfractured lesion
1195168|NCT00314236|P2|Participant Flow|Control|Microfracture alone
1195169|NCT00314236|P1|Participant Flow|Experimental|BST-CarGel applied to a Microfractured lesion
1195170|NCT00314236|O2|Outcome|Control|Microfracture alone
1195171|NCT00314236|O1|Outcome|Experimental|BST-CarGel applied to a Microfractured lesion
1195172|NCT00314236|O2|Outcome|Control|Microfracture alone
1195173|NCT00314236|O1|Outcome|Experimental|BST-CarGel applied to a Microfractured lesion
1195174|NCT00314236|O2|Outcome|Control|Microfracture alone
1195175|NCT00314236|O1|Outcome|Experimental|BST-CarGel applied to a Microfractured lesion
1195176|NCT00314236|O2|Outcome|Control|Microfracture alone
1195177|NCT00314236|O1|Outcome|Experimental|BST-CarGel applied to a Microfractured lesion
1195178|NCT00314236|E2|Reported Event|Control|Microfracture alone
1195179|NCT00314236|E1|Reported Event|Experimental|BST-CarGel applied to a Microfractured lesion
1195180|NCT00314145|B3|Baseline|Total|Total of all reporting groups
1195181|NCT00314145|B2|Baseline|ChimeriVax™-JE|All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms.
1195182|NCT00314145|B1|Baseline|JE-VAX®|All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
1195183|NCT00314145|P2|Participant Flow|ChimeriVax™-JE|All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms.
1195184|NCT00314145|P1|Participant Flow|JE-VAX®|All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
1195185|NCT00314145|O2|Outcome|ChimeriVax™-JE|All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms.
1195186|NCT00314145|O1|Outcome|JE-VAX®|All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
1195237|NCT00313846|O2|Outcome|Double-blind BTDS|Test treatment in the double-blind phase. Buprenorphine transdermal patches 5, 10, or 20 applied for 7-day wear.
1195187|NCT00314145|O2|Outcome|ChimeriVax™-JE|All participants received 1 subcutaneous dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 PFU and saline placebo into different arms.
1195188|NCT00314145|O1|Outcome|JE-VAX®|All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
1195189|NCT00314145|O2|Outcome|ChimeriVax™-JE|All participants received 1 subcutaneous dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 PFU and saline placebo into different arms.
1195190|NCT00314145|O1|Outcome|JE-VAX®|All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
1195623|NCT00313014|O3|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
1195191|NCT00314145|O2|Outcome|ChimeriVax™-JE|All participants received 1 subcutaneous dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 PFU and saline placebo into different arms.
1195192|NCT00314145|O1|Outcome|JE-VAX®|All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
1195193|NCT00314145|E2|Reported Event|ChimeriVax™-JE|All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms.
1195194|NCT00314145|E1|Reported Event|JE-VAX®|All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
1195195|NCT00314132|B3|Baseline|Total|Total of all reporting groups
1195196|NCT00314132|B2|Baseline|ChimeriVax™-JE 4 log10 PFU Vaccine|Participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.
1195197|NCT00314132|B1|Baseline|Placebo|Participants received a single injection of placebo on Day 0.
1195198|NCT00314132|P2|Participant Flow|ChimeriVax™-JE 4 log10 PFU Vaccine|Participants received a single injection of ChimeriVax™-JE 4 log10 Plaque-forming unit (PFU) Vaccine on Day 0.
1195199|NCT00314132|P1|Participant Flow|Placebo|Participants received a single injection of placebo on Day 0.
1195200|NCT00314132|O2|Outcome|ChimeriVax™-JE 4 log10 PFU Vaccine|Participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.
1195201|NCT00314132|O1|Outcome|Placebo|Participants received a single injection of placebo on Day 0.
1195202|NCT00314132|O2|Outcome|ChimeriVax™-JE 4 log10 PFU Vaccine|All participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.
1195203|NCT00314132|O1|Outcome|Placebo|All subjects received a single injection of placebo on Day 0.
1195204|NCT00314132|E2|Reported Event|ChimeriVax™-JE 4 log10 PFU Vaccine|Participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.
1195205|NCT00314132|E1|Reported Event|Placebo|Participants received a single injection of placebo on Day 0.
1195206|NCT00314106|B3|Baseline|Total|Total of all reporting groups
1195207|NCT00314106|B2|Baseline|TBI 1200 cGy + TIL +HD IL-2, no Prior IL-2|Patients that have not received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses)
1195208|NCT00314106|B1|Baseline|TBI 1200 cGy + TIL +HD IL-2, Prior IL-2|Patients that received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses).
1195209|NCT00314106|P2|Participant Flow|TBI 1200 cGy + TIL +HD IL-2, no Prior IL-2|Patients that have not received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses)
1195210|NCT00314106|P1|Participant Flow|TBI 1200 cGy + TIL +HD IL-2, Prior IL-2|Patients that received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses).
1195211|NCT00314106|O2|Outcome|TBI 1200 cGy + TIL +HD IL-2, no Prior IL-2|Patients that have not received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses)
1195212|NCT00314106|O1|Outcome|TBI 1200 cGy + TIL +HD IL-2, Prior IL-2|Patients that received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses).
1197009|NCT00308074|O1|Outcome|Aripiprazole|aripiprazole monotherapy
1195213|NCT00314106|O2|Outcome|TBI 1200 cGy + TIL +HD IL-2, no Prior IL-2|Patients that have not received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses)
1195310|NCT00313781|O2|Outcome|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
1195624|NCT00313014|O2|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
1195214|NCT00314106|O1|Outcome|TBI 1200 cGy + TIL +HD IL-2, Prior IL-2|Patients that received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses).
1195215|NCT00314106|E2|Reported Event|TBI 1200 cGy + TIL +HD IL-2, no Prior IL-2|Patients that have not received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses)
1195216|NCT00314106|E1|Reported Event|TBI 1200 cGy + TIL +HD IL-2, Prior IL-2|Patients that received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses).
1195217|NCT00313911|B3|Baseline|Total|Total of all reporting groups
1195218|NCT00313911|B2|Baseline|Tritanrix-Hep B/Hib™ + OPV|Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
1195219|NCT00313911|B1|Baseline|DTaP-IPV-Hep B-PRP~T|Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
1195220|NCT00313911|P2|Participant Flow|Tritanrix-Hep B/Hib™ + OPV|Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
1195221|NCT00313911|P1|Participant Flow|DTaP-IPV-Hep B-PRP~T|Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
1195222|NCT00313911|O2|Outcome|Tritanrix-Hep B/Hib™ + OPV|Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
1195223|NCT00313911|O1|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
1195224|NCT00313911|O2|Outcome|Tritanrix-Hep B/Hib™ + OPV|Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
1195225|NCT00313911|O1|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
1195226|NCT00313911|O2|Outcome|Tritanrix-Hep B/Hib™ + OPV|Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
1195227|NCT00313911|O1|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
1195228|NCT00313911|O2|Outcome|Tritanrix-Hep B/Hib™ + OPV|Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
1195229|NCT00313911|O1|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
1195230|NCT00313911|E2|Reported Event|Tritanrix-Hep B/Hib™ + OPV|Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
1195231|NCT00313911|E1|Reported Event|DTaP-IPV-Hep B-PRP~T|Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
1195232|NCT00313846|B3|Baseline|Total|Total of all reporting groups
1195233|NCT00313846|B2|Baseline|Double-blind BTDS|Test treatment in the double-blind phase. Buprenorphine transdermal patches 5, 10, or 20 applied for 7-day wear.
1195234|NCT00313846|B1|Baseline|Double-blind Placebo|Reference treatment in the double-blind phase. Placebo transdermal patches matched the BTDS patches applied for 7-day wear.
1195238|NCT00313846|O1|Outcome|Double-blind Placebo|Reference treatment in the double-blind phase. Placebo transdermal patches matched the BTDS patches applied for 7-day wear.
1195239|NCT00313846|O2|Outcome|Double-blind BTDS|Test treatment in the double-blind phase. Buprenorphine transdermal patches 5, 10, or 20 applied for 7-day wear.
1195240|NCT00313846|O1|Outcome|Double-blind Placebo|Reference treatment in the double-blind phase. Placebo transdermal patches matched the BTDS patches applied for 7-day wear.
1195241|NCT00313846|E3|Reported Event|Open-label Run-in Period BTDS 5, 10, or 20|Open-label Run-in Period (less than or equal to 21 days): All subjects began treatment on BTDS 5 and titrated to a maximum of BTDS 20 to achieve effective pain control. Subjects were treated for a minimum of 3 days with any given dose of BTDS before up-titration to the next strength patch was considered. One down-titration was permitted. Subjects meeting protocol-defined criteria for adequate analgesia within 21 days were eligible for entry into the double-blind phase.
1195242|NCT00313846|E2|Reported Event|Double-blind BTDS 5, 10, or 20|Test treatments in the double-blind phase
1195243|NCT00313846|E1|Reported Event|Double-blind Placebo Patch 5, 10, or 20|Reference treatment in the double-blind phase
1195244|NCT00313820|B3|Baseline|Total|Total of all reporting groups
1195245|NCT00313820|B2|Baseline|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195246|NCT00313820|B1|Baseline|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195247|NCT00313820|P2|Participant Flow|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195248|NCT00313820|P1|Participant Flow|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195249|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195250|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195251|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195252|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195253|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195254|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195255|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195614|NCT00313014|B3|Baseline|Double-blind Oxycodone Immediate-Release|Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
1195256|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195257|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195258|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195259|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195260|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195261|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195262|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195263|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195264|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195265|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195266|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195267|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195268|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195269|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195270|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195271|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195272|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195273|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195274|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195275|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195276|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195277|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195278|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195279|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195280|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195281|NCT00313820|E2|Reported Event|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195282|NCT00313820|E1|Reported Event|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
1195283|NCT00313781|B3|Baseline|Total|Total of all reporting groups
1195284|NCT00313781|B2|Baseline|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
1195308|NCT00313781|O2|Outcome|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
1195285|NCT00313781|B1|Baseline|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
1195343|NCT00313716|O2|Outcome|TT10 Group|Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 arm, Epo2/TT10 arm, and Placebo/TT10 arm combined)
1199160|NCT00301262|O3|Outcome|DB Placebo Week 8|
1195286|NCT00313781|P3|Participant Flow|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
1195287|NCT00313781|P2|Participant Flow|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
1195288|NCT00313781|P1|Participant Flow|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion intravenously (IV) over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21 days cycle, up to 17 cycles.
1195289|NCT00313781|O2|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
1195290|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
1195291|NCT00313781|O2|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
1195292|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
1195293|NCT00313781|O2|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
1195294|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
1195295|NCT00313781|O2|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
1195296|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
1195297|NCT00313781|O3|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
1195298|NCT00313781|O2|Outcome|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
1195299|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
1195300|NCT00313781|O3|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
1195301|NCT00313781|O2|Outcome|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
1195302|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
1195303|NCT00313781|O2|Outcome|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
1195304|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
1195305|NCT00313781|O2|Outcome|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
1195306|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
1195307|NCT00313781|O3|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
1195615|NCT00313014|B2|Baseline|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
1195309|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
1195311|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
1195312|NCT00313781|O3|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
1195313|NCT00313781|O2|Outcome|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
1195314|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
1195315|NCT00313781|O3|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
1195316|NCT00313781|O2|Outcome|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
1195317|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
1195318|NCT00313781|E3|Reported Event|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
1195319|NCT00313781|E2|Reported Event|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
1195320|NCT00313781|E1|Reported Event|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
1195321|NCT00313716|B7|Baseline|Total|Total of all reporting groups
1195322|NCT00313716|B6|Baseline|Placebo/TT10 Arm|Patients received saline and transfused to keep hemoglobin concentration at least 10 g/dl
1195323|NCT00313716|B5|Baseline|Epo2/TT10 Arm|Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury and transfused to keep hemoglobin concentration at least 10 g/dl
1195324|NCT00313716|B4|Baseline|Epo1/TT10 Arm|Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury and transfused to keep hemoglobin at least 10 g/dl
1195325|NCT00313716|B3|Baseline|Placebo/TT7 Arm|Patients received saline and transfused to keep hemoglobin concentration at least 7 g/dl
1195326|NCT00313716|B2|Baseline|Epo2/TT7 Arm|Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury and transfused to keep hemoglobin concentration at least 7 g/dl
1195327|NCT00313716|B1|Baseline|Epo1/TT7 Arm|Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury and transfused to keep hemoglobin at least 7 g/dl
1195328|NCT00313716|P6|Participant Flow|Placebo/TT10 Arm|Placebo (patients received saline) and hemoglobin transfusion threshold 10 gm/dl
1195329|NCT00313716|P5|Participant Flow|Epo2/TT10 Arm|Low dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 10 gm/dl
1195330|NCT00313716|P4|Participant Flow|Epo1/TT10 Arm|High dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 10 gm/dl
1195331|NCT00313716|P3|Participant Flow|Placebo/TT7 Arm|Placebo (patients received saline) and hemoglobin transfusion threshold 7 gm/dl
1195332|NCT00313716|P2|Participant Flow|Epo2/TT7 Arm|Low dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 7 gm/dl
1195333|NCT00313716|P1|Participant Flow|Epo1/TT7 Arm|High dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 7 gm/dl
1195334|NCT00313716|O2|Outcome|TT10 Group|Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 group, Epo2/TT10 group, and Placebo/TT10 group combined)
1195335|NCT00313716|O1|Outcome|TT7 Group|Patients had hemoglobin concentration maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
1195336|NCT00313716|O2|Outcome|TT10 Group|Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 arm, Epo2/TT10 arm, and Placebo/TT10 arm combined)
1195337|NCT00313716|O1|Outcome|TT7 Group|Patients had hemoglobin concentration maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
1195338|NCT00313716|O5|Outcome|TT10 Group|Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 arm, Epo2/TT10 arm, and Placebo/TT10 arm combined)
1195339|NCT00313716|O4|Outcome|TT7 Group|Patients had hemoglobin maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
1195340|NCT00313716|O3|Outcome|Placebo Group|Patients received saline (Placebo/TT10 arm and Placebo/TT7 arm combined)
1195341|NCT00313716|O2|Outcome|Epo2 Group|Patients received 500 IU/kg within 6 hrs after injury, and at 9 and 16 days after injury (Epo2/TT10 arm and Epo2/TT7 arm combined)
1195342|NCT00313716|O1|Outcome|Epo1 Group|Patients received 500 IU/kg erythropoietin within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury (Epo1/TT10 arm and Epo1/TT7 arm combined)
1199161|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
1195345|NCT00313716|O5|Outcome|TT10 Group|Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 arm, Epo2/TT10 arm, and Placebo/TT10 arm combined)
1195346|NCT00313716|O4|Outcome|TT7 Group|Patients had hemoglobin concentration maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
1195347|NCT00313716|O3|Outcome|Placebo Group|Patients received saline (Placebo/TT10 arm and Placebo/TT7 arm combined)
1195348|NCT00313716|O2|Outcome|Epo2 Group|Patients received erythropoietin 500 IU/kg within 6hrs of injury, and at 9 and 16 days after injury (Epo2/TT10 arm and Epo2/TT7 arm combined)
1195349|NCT00313716|O1|Outcome|Epo1 Group|Patients received erythropoietin 500 IU/kg within 6hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury (Epo1/TT10 arm and Epo1/TT7 arm combined)
1195350|NCT00313716|E5|Reported Event|TT10 Group|Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 arm, Epo2/TT10 arm, and Placebo/TT10 arm combined)
1195351|NCT00313716|E4|Reported Event|TT7 Group|Patients had hemoglobin concentration maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
1195352|NCT00313716|E3|Reported Event|Placebo Group|Patients received saline (Placebo/TT10 arm and Placebo/TT7 arm combined)
1195353|NCT00313716|E2|Reported Event|Epo2 Group|Patients received erythropoietin 500 IU/kg within 6 hrs of injury, and at 9 and 16 days after injury (Epo1/TT10 arm and Epo1/TT7 arm combined)
1195354|NCT00313716|E1|Reported Event|Epo1 Group|Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury (Epo1/TT10 arm and Epo1/TT7 arm combined)
1195355|NCT00313703|B5|Baseline|Total|Total of all reporting groups
1195356|NCT00313703|B4|Baseline|Other|Met other International Headache Society criteria
1195357|NCT00313703|B3|Baseline|Unclassifiable|Had recurrent headache disorder but did not meet any International Headache Society criteria
1195358|NCT00313703|B2|Baseline|Tension-type Headache|met International Headache Society tension-type headache criteria
1195359|NCT00313703|B1|Baseline|Migraine|met International Headache Society migraine criteria
1195360|NCT00313703|P4|Participant Flow|Other|Met other International Headache Society criteria
1195361|NCT00313703|P3|Participant Flow|Unclassifiable|Had recurrent headache disorder but did not meet any International Headache Society criteria
1195362|NCT00313703|P2|Participant Flow|Tension-type Headache|met International Headache Society tension-type headache criteria
1195363|NCT00313703|P1|Participant Flow|Migraine|met International Headache Society migraine criteria
1195364|NCT00313703|O4|Outcome|Other|Met other International Headache Society criteria
1195365|NCT00313703|O3|Outcome|Unclassifiable|Had recurrent headache disorder but did not meet any International Headache Society criteria
1195366|NCT00313703|O2|Outcome|Tension-type Headache|met International Headache Society tension-type headache criteria
1195367|NCT00313703|O1|Outcome|Migraine|met International Headache Society migraine criteria
1195368|NCT00313703|O4|Outcome|Other|Met other International Headache Society criteria
1195369|NCT00313703|O3|Outcome|Unclassifiable|Had recurrent headache disorder but did not meet any International Headache Society criteria
1195370|NCT00313703|O2|Outcome|Tension-type Headache|met International Headache Society tension-type headache criteria
1195371|NCT00313703|O1|Outcome|Migraine|met International Headache Society migraine criteria
1195372|NCT00313703|E4|Reported Event|Other|Met other International Headache Society criteria
1195373|NCT00313703|E3|Reported Event|Unclassifiable|Had recurrent headache disorder but did not meet any International Headache Society criteria
1195374|NCT00313703|E2|Reported Event|Tension-type Headache|met International Headache Society tension-type headache criteria
1195375|NCT00313703|E1|Reported Event|Migraine|met International Headache Society migraine criteria
1195376|NCT00313612|B3|Baseline|Total|Total of all reporting groups
1195377|NCT00313612|B2|Baseline|Treatment Stratum II (Oxaliplatin Plus Topotecan)|"Treatment stratum II (oxaliplatin plus topotecan) is sensitive to prior platinum therapy. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
1195378|NCT00313612|B1|Baseline|Treatment Stratum I: (Oxaliplatin Plus Topotecan)|"Treatment stratum I (oxaliplatin plus topotecan) is resistant to prior platinum therapy. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
1195379|NCT00313612|P2|Participant Flow|Treatment Stratum II (Oxaliplatin Plus Topotecan)|"Treatment stratum II (oxaliplatin plus topotecan) is sensitive to prior platinum therapy. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
1195380|NCT00313612|P1|Participant Flow|Treatment Stratum I (Oxaliplatin Plus Topotecan)|"Treatment stratum I (oxaliplatin plus topotecan) is resistant to prior platinum therapy. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
1195381|NCT00313612|O2|Outcome|Treatment Stratum II (Oxaliplatin Plus Topotecan)|"Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
1195382|NCT00313612|O1|Outcome|Treatment Stratum I (Oxaliplatin Plus Topotecan)|"Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
1195383|NCT00313612|O2|Outcome|Treatment Stratum II (Oxaliplatin Plus Topotecan)|"Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
1195384|NCT00313612|O1|Outcome|Treatment Stratum I (Oxaliplatin Plus Topotecan)|"Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
1195385|NCT00313612|E2|Reported Event|Treatment Stratum II (Oxaliplatin Plus Topotecan)|"Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
1195386|NCT00313612|E1|Reported Event|Treatment Stratum I (Oxaliplatin Plus Topotecan)|"Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
1195387|NCT00313586|B5|Baseline|Total|Total of all reporting groups
1195388|NCT00313586|B4|Baseline|Arm B (Azacitidine + Entinostat; Treatment-induced Cohort)|Treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
1195389|NCT00313586|B3|Baseline|Arm A (Azacitidine; Treatment-induced Cohort)|Treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
1195390|NCT00313586|B2|Baseline|Arm B (Azacitidine + Entinostat; Non-treatment-induced Cohort)|Non-treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
1195391|NCT00313586|B1|Baseline|Arm A (Azacitidine; Non-treatment-induced Cohort)|Non-treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
1195392|NCT00313586|P4|Participant Flow|Arm B (Azacitidine + Entinostat; Treatment-induced Cohort)|Treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
1195393|NCT00313586|P3|Participant Flow|Arm A (Azacitidine; Treatment-induced Cohort)|Treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
1195394|NCT00313586|P2|Participant Flow|Arm B (Azacitidine + Entinostat; Non-treatment-induced Cohort)|Non-treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
1195395|NCT00313586|P1|Participant Flow|Arm A (Azacitidine; Non-treatment-induced Cohort)|Non-treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
1195396|NCT00313586|O4|Outcome|Arm B (Azacitidine + Entinostat; Treatment-induced Cohort)|Treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
1195397|NCT00313586|O3|Outcome|Arm A (Azacitidine; Treatment-induced Cohort)|Treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
1195398|NCT00313586|O2|Outcome|Arm B (Azacitidine + Entinostat; Non-treatment-induced Cohort)|Non-treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
1195399|NCT00313586|O1|Outcome|Arm A (Azacitidine; Non-treatment-induced Cohort)|Non-treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
1195400|NCT00313586|E2|Reported Event|Arm B (Azacitidine + Entinostat)|Patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
1195401|NCT00313586|E1|Reported Event|Arm A (Azacitidine)|Patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
1195402|NCT00313443|B1|Baseline|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
1195403|NCT00313443|P1|Participant Flow|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
1195404|NCT00313443|O1|Outcome|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
1195405|NCT00313443|O1|Outcome|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
1195406|NCT00313443|O1|Outcome|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
1195407|NCT00313443|O1|Outcome|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
1195408|NCT00313443|O1|Outcome|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
1195409|NCT00313443|E1|Reported Event|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
1195410|NCT00313313|B4|Baseline|Total|Total of all reporting groups
1195427|NCT00313313|O2|Outcome|Saxagliptin 5 mg + Glyburide 7.5 mg|The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
1195411|NCT00313313|B3|Baseline|Placebo + Glyburide 7.5 mg|The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
1195452|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also, ≤165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
1195775|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
1195412|NCT00313313|B2|Baseline|Saxagliptin 5 mg + Glyburide 7.5 mg|The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
1195413|NCT00313313|B1|Baseline|Saxagliptin 2.5 mg + Glyburide 7.5 mg|The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
1195414|NCT00313313|P3|Participant Flow|Placebo + Glyburide 7.5 mg|The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
1195415|NCT00313313|P2|Participant Flow|Saxagliptin 5 mg + Glyburide 7.5 mg|The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
1195416|NCT00313313|P1|Participant Flow|Saxagliptin 2.5 mg + Glyburide 7.5 mg|The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
1195417|NCT00313313|O3|Outcome|Placebo + Glyburide 7.5 mg|The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
1195418|NCT00313313|O2|Outcome|Saxagliptin 5 mg + Glyburide 7.5 mg|The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
1195419|NCT00313313|O1|Outcome|Saxagliptin 2.5 mg + Glyburide 7.5 mg|The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
1195420|NCT00313313|O3|Outcome|Placebo + Glyburide 7.5 mg|The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
1195421|NCT00313313|O2|Outcome|Saxagliptin 5 mg + Glyburide 7.5 mg|The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
1195422|NCT00313313|O1|Outcome|Saxagliptin 2.5 mg + Glyburide 7.5 mg|The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
1195423|NCT00313313|O3|Outcome|Placebo + Glyburide 7.5 mg|The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
1195424|NCT00313313|O2|Outcome|Saxagliptin 5 mg + Glyburide 7.5 mg|The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
1195425|NCT00313313|O1|Outcome|Saxagliptin 2.5 mg + Glyburide 7.5 mg|The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
1195426|NCT00313313|O3|Outcome|Placebo + Glyburide 7.5 mg|The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
1195449|NCT00313300|O4|Outcome|Apixaban 10mg BID|"Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B this treatment group was terminated."
1195428|NCT00313313|O1|Outcome|Saxagliptin 2.5 mg + Glyburide 7.5 mg|The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
1195620|NCT00313014|O3|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
1195429|NCT00313313|E3|Reported Event|Saxagliptin 5 mg + Glyburide 7.5 mg|The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
1195430|NCT00313313|E2|Reported Event|Saxagliptin 2.5 mg + Glyburide 7.5 mg|The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
1195431|NCT00313313|E1|Reported Event|Placebo + Glyburide 7.5 mg|The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
1195432|NCT00313300|B6|Baseline|Total|Total of all reporting groups
1195433|NCT00313300|B5|Baseline|Apixaban 20 mg QD|"Tablet of apixaban, oral, for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B, this treatment group was terminated."
1195434|NCT00313300|B4|Baseline|Apixaban 10mg BID|"Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B, this treatment group was terminated"
1195435|NCT00313300|B3|Baseline|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
1195436|NCT00313300|B2|Baseline|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
1195437|NCT00313300|B1|Baseline|Placebo|Tablet of Placebo for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
1195438|NCT00313300|P5|Participant Flow|Apixaban 20 mg QD|"Phase B of the Study: Tablet of Apixaban 20 mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B, the DSMB recommended that the apixaban 20 mg QD group, be terminated due to excess bleeding for participants receiving aspirin and clopidogrel concomitantly with the apixaban. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants)."
1195439|NCT00313300|P4|Participant Flow|Apixaban 10mg BID|"Phase B of the Study: Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B, the DSMB recommended that the 10 mg BID QD group, be terminated due to excess bleeding for participants receiving aspirin and clopidogrel concomitantly with the 10 mg BID apixaban. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants)."
1195440|NCT00313300|P3|Participant Flow|Apixaban 10mg QD|In both Phase A and Phase B of the study: Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants).
1195441|NCT00313300|P2|Participant Flow|Apixaban 2.5mg BID|In both Phase A and Phase B of the study: Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants).
1195442|NCT00313300|P1|Participant Flow|Placebo|Study was conducted in 2 Phases (A and B). A tablet of Placebo along with ≤ 165 mg of aspirin was given daily for 26 weeks. 75 mg of clopidogrel once a day (QD) was allowed at the investigator’s discretion. After 547 subjects were randomized to Phase A, an independent Data and Safety Monitoring Board (DSMB) recommended expanding the randomization to 2 higher doses of apixaban (10 mg BID and 20 mg QD) in Phase B of the study. Approximately 6 months after the start of Phase B, the DSMB recommended apixaban high dose groups be terminated due to excess bleeding in those participants receiving aspirin and clopidogrel concomitantly with high dose apixaban. Treatment and any new randomization into these 2 groups was halted, while randomization and treatment in the placebo and lower dose apixaban groups continued. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants).
1195443|NCT00313300|O5|Outcome|Apixaban 20 mg QD|"Tablet of apixaban QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B this treatment group was terminated."
1195444|NCT00313300|O4|Outcome|Apixaban 10mg BID|"Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B this treatment group was terminated."
1195445|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
1195446|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
1195447|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
1195448|NCT00313300|O5|Outcome|Apixaban 20 mg QD|"Tablet of apixaban QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B this treatment group was terminated."
1195544|NCT00313144|O4|Outcome|>12 Months to ≤18 Months|
1195545|NCT00313144|O3|Outcome|>6 Months to ≤12 Months|
1195450|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
1195451|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
1195453|NCT00313300|O5|Outcome|Apixaban 20 mg QD|"Tablet of apixaban QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B this treatment group was terminated."
1195454|NCT00313300|O4|Outcome|Apixaban 10mg BID|"Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B this treatment group was terminated."
1195455|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
1195456|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
1195457|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
1195458|NCT00313300|O5|Outcome|Apixaban 20 mg QD|"Tablet of apixaban QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B this treatment group was terminated."
1195459|NCT00313300|O4|Outcome|Apixaban 10mg BID|"Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B this treatment group was terminated."
1195460|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
1195461|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
1195462|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo, oral, for 26 weeks. Also ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
1195463|NCT00313300|O5|Outcome|Apixaban 20 mg QD|"Tablet of apixaban QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B this treatment group was terminated."
1195464|NCT00313300|O4|Outcome|Apixaban 10mg BID|"Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B this treatment group was terminated."
1195465|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
1195466|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
1195467|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also, ≤165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
1195468|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
1195469|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
1195470|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also, ≤165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
1195471|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
1195472|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
1195473|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also, ≤165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
1195474|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
1195475|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
1195476|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also, ≤165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
1195477|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
1195478|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
1195479|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also, less than, equal to (≤) 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
1195480|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
1195481|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
1195482|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also, less than, equal to (≤) 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
1195546|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
1195483|NCT00313300|E8|Reported Event|Phase B Placebo|Participants treated with at least one dose of Placebo during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)
1195484|NCT00313300|E7|Reported Event|Phase B Apixaban 2.5mg BID|Participants treated with at least one dose of 2.5 mg BID apixaban during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)
1195621|NCT00313014|O2|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
1195485|NCT00313300|E6|Reported Event|Phase B Apixaban 20mg QD|Participants treated with at least one dose of 20 mg QD apixaban during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)
1195486|NCT00313300|E5|Reported Event|Phase B Apixaban 10mg QD|Participants treated with at least one dose of 10 mg QD apixaban during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)
1195487|NCT00313300|E4|Reported Event|Phase B Apixaban 10mg BID|Participants treated with at least one dose of 10 mg BID apixaban during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)
1195488|NCT00313300|E3|Reported Event|Phase A+B Placebo|Total Phase A and Phase B participants combined who received at least 1 dose of placebo during the study.
1195489|NCT00313300|E2|Reported Event|Phase A+B Apixaban 2.5mg BID|Total Phase A and Phase B participants combined who received at least 1 dose of 2.5 mg BID apixaban during the study.
1195490|NCT00313300|E1|Reported Event|Phase A+B Apixaban 10mg QD|Total Phase A and Phase B participants combined who received at least 1 dose of 10 mg QD apixaban during the study.
1195491|NCT00313209|B3|Baseline|Total|Total of all reporting groups
1195492|NCT00313209|B2|Baseline|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
1195493|NCT00313209|B1|Baseline|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
1195494|NCT00313209|P2|Participant Flow|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
1195495|NCT00313209|P1|Participant Flow|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
1195496|NCT00313209|O2|Outcome|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
1195497|NCT00313209|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
1195498|NCT00313209|O2|Outcome|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
1195499|NCT00313209|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
1195500|NCT00313209|O2|Outcome|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
1195501|NCT00313209|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
1195502|NCT00313209|O2|Outcome|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
1195503|NCT00313209|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
1195504|NCT00313209|O2|Outcome|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
1195505|NCT00313209|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
1195506|NCT00313209|E2|Reported Event|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
1195507|NCT00313209|E1|Reported Event|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
1195508|NCT00313170|B4|Baseline|Total|Total of all reporting groups
1195509|NCT00313170|B3|Baseline|Fulvestrant 500 mg|Fulvestrant 500 mg
1195510|NCT00313170|B2|Baseline|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
1195511|NCT00313170|B1|Baseline|Fulvestrant 250 mg|Fulvestrant 250 mg
1195512|NCT00313170|P3|Participant Flow|Fulvestrant 500 mg|Fulvestrant 500 mg
1195513|NCT00313170|P2|Participant Flow|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
1195514|NCT00313170|P1|Participant Flow|Fulvestrant 250 mg|Fulvestrant 250 mg
1195515|NCT00313170|O1|Outcome|Fulvestrant|Fulvestrant arms pooled
1195516|NCT00313170|O1|Outcome|Fulvestrant|Fulvestrant arms pooled
1195517|NCT00313170|O3|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
1195518|NCT00313170|O2|Outcome|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
1195519|NCT00313170|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg
1195520|NCT00313170|O3|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
1195521|NCT00313170|O2|Outcome|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
1195522|NCT00313170|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg
1195523|NCT00313170|O3|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
1195524|NCT00313170|O2|Outcome|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
1195525|NCT00313170|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg
1195526|NCT00313170|E3|Reported Event|Fulvestrant 500 mg|Fulvestrant 500 mg
1195527|NCT00313170|E2|Reported Event|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
1195528|NCT00313170|E1|Reported Event|Fulvestrant 250 mg|Fulvestrant 250 mg
1195529|NCT00313144|B1|Baseline|Overall Study|
1195530|NCT00313144|P1|Participant Flow|Overall Study|Participants were treated with ARALAST according to dose and frequency of infusions recommended by their physician.
1195531|NCT00313144|O4|Outcome|>18 Months to ≤24 Months|
1195532|NCT00313144|O3|Outcome|>12 Months to ≤18 Months|
1195533|NCT00313144|O2|Outcome|>6 Months to ≤12 Months|
1195534|NCT00313144|O1|Outcome|Baseline to ≤6 Months|
1195535|NCT00313144|O4|Outcome|>18 Months to ≤24 Months|
1195536|NCT00313144|O3|Outcome|>12 Months to ≤18 Months|
1195537|NCT00313144|O2|Outcome|>6 Months to ≤12 Months|
1195538|NCT00313144|O1|Outcome|Baseline to ≤6 Months|
1195539|NCT00313144|O4|Outcome|>18 Months to ≤24 Months|
1195540|NCT00313144|O3|Outcome|>12 Months to ≤18 Months|
1195541|NCT00313144|O2|Outcome|>6 Months to ≤12 Months|
1195542|NCT00313144|O1|Outcome|Baseline to ≤6 Months|
1195543|NCT00313144|O5|Outcome|>18 Months to ≤24 Months|
1195617|NCT00313014|P3|Participant Flow|Double-blind Oxycodone Immediate-Release|Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
1195618|NCT00313014|P2|Participant Flow|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
1195619|NCT00313014|P1|Participant Flow|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
1199162|NCT00301262|O1|Outcome|DB Viagra Week 8|
1195626|NCT00313014|O3|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
1195627|NCT00313014|O2|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
1195628|NCT00313014|O1|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
1195629|NCT00313014|O3|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
1195630|NCT00313014|O2|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
1195631|NCT00313014|O1|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
1195632|NCT00313014|E4|Reported Event|Open-label Run-in Period, BTDS 10/20|Open-label BTDS 10 or 20 mcg/h applied for 7-day wear
1195633|NCT00313014|E3|Reported Event|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
1195634|NCT00313014|E2|Reported Event|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
1195635|NCT00313014|E1|Reported Event|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
1195636|NCT00312923|B3|Baseline|Total|Total of all reporting groups
1195637|NCT00312923|B2|Baseline|Control Group|Placebo : Two capsules of 10 mg of microcrystalline cellulose daily
1195638|NCT00312923|B1|Baseline|Treatment Group|"20 mg daily of policosanol~Policosanol : 20 mg of policosanol in capsular form daily"
1195639|NCT00312923|P2|Participant Flow|Control Group|Placebo : Two capsules of 10 mg of microcrystalline cellulose daily
1195640|NCT00312923|P1|Participant Flow|Treatment Group|"20 mg daily of policosanol~Policosanol : 20 mg of policosanol in capsular form daily"
1195641|NCT00312923|O2|Outcome|Control Group|Placebo : Two capsules of 10 mg of microcrystalline cellulose daily
1195642|NCT00312923|O1|Outcome|Treatment Group|"20 mg daily of policosanol~Policosanol : 20 mg of policosanol in capsular form daily"
1195643|NCT00312923|O2|Outcome|Control Group|Placebo : Two capsules of 10 mg of microcrystalline cellulose daily
1195644|NCT00312923|O1|Outcome|Treatment Group|"20 mg daily of policosanol~Policosanol : 20 mg of policosanol in capsular form daily"
1195645|NCT00312923|E2|Reported Event|Control Group|Placebo : Two capsules of 10 mg of microcrystalline cellulose daily
1195646|NCT00312923|E1|Reported Event|Treatment Group|"20 mg daily of policosanol~Policosanol : 20 mg of policosanol in capsular form daily"
1195647|NCT00312884|B3|Baseline|Total|Total of all reporting groups
1195648|NCT00312884|B2|Baseline|Intervention Arm|Received daily home monitoring
1195649|NCT00312884|B1|Baseline|Usual Care|Recieved usual follow-up care
1195650|NCT00312884|P2|Participant Flow|Usual Care|Received usual hospital care with no Telemonitoring
1195651|NCT00312884|P1|Participant Flow|Intervention Arm|Recieved home telemonitoring daily HomMed Telemonitoring System: The HomeMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home
1195652|NCT00312884|O2|Outcome|Intervention Arm|"Recieved telemonitoring~HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
1195653|NCT00312884|O1|Outcome|Usual Care|"Recieved usual hospital and community care~HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
1195654|NCT00312884|O2|Outcome|Intervention Arm|"Recieved telemonitoring~HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
1195655|NCT00312884|O1|Outcome|Usual Care|"Recieved usual hospital and community care~HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
1195656|NCT00312884|O2|Outcome|Intervention Arm|"Recieved telemonitoring~HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
1195657|NCT00312884|O1|Outcome|Usual Care|"Recieved usual hospital and community care~HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
1195658|NCT00312884|O2|Outcome|Intervention Arm|"Recieved telemonitoring~HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
1195659|NCT00312884|O1|Outcome|Usual Care|"Recieved usual hospital and community care~HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
1195660|NCT00312884|E2|Reported Event|Intervention Arm|Recieved telemonitoring daily via the HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home
1195661|NCT00312884|E1|Reported Event|Usual Care|Recieved usual hospital care
1195662|NCT00312858|B3|Baseline|Total|Total of all reporting groups
1195663|NCT00312858|B2|Baseline|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
1195664|NCT00312858|B1|Baseline|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
1195665|NCT00312858|P2|Participant Flow|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
1195666|NCT00312858|P1|Participant Flow|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
1195667|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
1195668|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
1195669|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
1195670|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
1195671|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
1195672|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
1195673|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
1195674|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
1195675|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
1195676|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
1195677|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
1195678|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
1195679|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
1195680|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
1195681|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
1195724|NCT00312845|O2|Outcome|Rituximab|375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses).
1197010|NCT00308074|E1|Reported Event|Aripiprazole|aripiprazole monotherapy
1195682|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
1195683|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
1195684|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
1195728|NCT00312728|B1|Baseline|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
1195685|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
1195686|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
1195687|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
1195688|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
1195689|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
1195690|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
1195691|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
1195692|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
1195693|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
1195694|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
1195695|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
1195696|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
1195697|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
1195698|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
1195699|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
1195700|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
1195701|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
1195763|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
1195702|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
1195703|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
1195704|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
1195705|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
1195706|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
1195707|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
1195708|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
1195709|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
1195710|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
1195711|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
1195712|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
1195713|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
1195714|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
1195715|NCT00312858|E2|Reported Event|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
1195716|NCT00312858|E1|Reported Event|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
1195717|NCT00312845|B3|Baseline|Total|Total of all reporting groups
1195718|NCT00312845|B2|Baseline|Rituximab|375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses).
1195719|NCT00312845|B1|Baseline|Bortezomib + Rituximab|1.6 mg/m^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab).
1195720|NCT00312845|P2|Participant Flow|Rituximab|375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses).
1195721|NCT00312845|P1|Participant Flow|Bortezomib + Rituximab|1.6 mg/m^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab).
1195722|NCT00312845|O2|Outcome|Rituximab|375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses).
1195723|NCT00312845|O1|Outcome|Bortezomib + Rituximab|1.6 mg/m^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab).
1196484|NCT00309608|O5|Outcome|Glimepiride|Patients randomized to receive treatment with Glimepiride
1195725|NCT00312845|O1|Outcome|Bortezomib + Rituximab|1.6 mg/m^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab).
1195726|NCT00312845|E2|Reported Event|Rituximab|375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses).
1195727|NCT00312845|E1|Reported Event|Bortezomib + Rituximab|1.6 mg/m^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab).
1195773|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
1195729|NCT00312728|P1|Participant Flow|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
1195730|NCT00312728|O1|Outcome|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
1195731|NCT00312728|O1|Outcome|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
1195732|NCT00312728|O1|Outcome|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
1195733|NCT00312728|O1|Outcome|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
1195734|NCT00312728|O1|Outcome|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
1195735|NCT00312728|O1|Outcome|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
1195736|NCT00312728|E1|Reported Event|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
1195737|NCT00312572|B3|Baseline|Total|Total of all reporting groups
1195738|NCT00312572|B2|Baseline|Double-blind BTDS 20|Initial doses (Level 1) of BTDS 20. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
1195739|NCT00312572|B1|Baseline|Double-blind BTDS 10/20|Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their dose adjusted to BTDS 20 (Level 2) on or after day 4. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
1195740|NCT00312572|P2|Participant Flow|Double-blind BTDS 20|Initial doses (Level 1) of BTDS 20. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
1195741|NCT00312572|P1|Participant Flow|Double-blind BTDS 10/20|Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their dose adjusted to BTDS 20 (Level 2) on or after day 4. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
1195742|NCT00312572|O3|Outcome|Combined Total|Combined percentages from BTDS 10/20 and BTDS 20
1195743|NCT00312572|O2|Outcome|Double-blind BTDS 20|Initial doses (Level 1) of BTDS 20. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
1195744|NCT00312572|O1|Outcome|Double-blind BTDS 10/20|Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their dose adjusted to BTDS 20 (Level 2) on or after day 4. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
1195745|NCT00312572|E3|Reported Event|Open-label Run-in Period - Vicodin|N = 266 subjects received a stable regimen of Vicodin® in the Run-in period and were eligible for randomization if they reported a daily “average pain over the last 24 hours” score of 0 = none or 1 = mild on at least 5 of the 7 days; and used ≤ 2 doses of supplemental analgesic per day for their osteoarthritic (OA) pain. N = 204 completed the run-in.
1195746|NCT00312572|E2|Reported Event|Double-blind BTDS 20|Initial doses (Level 1) of BTDS 20. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
1195747|NCT00312572|E1|Reported Event|Double-blind BTDS 10/20|Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their dose adjusted to BTDS 20 (Level 2) on or after day 4. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
1195748|NCT00312494|B4|Baseline|Total|Total of all reporting groups
1195749|NCT00312494|B3|Baseline|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
1195750|NCT00312494|B2|Baseline|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
1195751|NCT00312494|B1|Baseline|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
1195752|NCT00312494|P3|Participant Flow|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
1195753|NCT00312494|P2|Participant Flow|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
1195754|NCT00312494|P1|Participant Flow|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
1195755|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
1195756|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
1195757|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
1195758|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
1195759|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
1195760|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
1195761|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
1195762|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
1195764|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
1195765|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
1195766|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
1195767|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
1195768|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
1195769|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
1195770|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
1195771|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
1195772|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
1195776|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
1195777|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
1195778|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
1195779|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
1195780|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
1195781|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
1195782|NCT00312494|E3|Reported Event|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
1195783|NCT00312494|E2|Reported Event|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
1195784|NCT00312494|E1|Reported Event|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
1195785|NCT00312377|B3|Baseline|Total|Total of all reporting groups
1195786|NCT00312377|B2|Baseline|Placebo Plus Docetaxel|Placebo plus docetaxel
1195787|NCT00312377|B1|Baseline|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
1195788|NCT00312377|P2|Participant Flow|Placebo Plus Docetaxel|Placebo tablet taken once daily plus docetaxel 75 mg/m2 IVb infusion every 21 days up to a maximum of 6 cycles
1195789|NCT00312377|P1|Participant Flow|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg oral tablet taken once daily in combination with docetaxel 75 mg/m2 IVb infusion every 21 days up to a maximum of 6 cycles
1195790|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
1195791|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
1195792|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
1195793|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
1195794|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
1195795|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
1195796|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
1195797|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
1195798|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
1195799|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
1195800|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
1195801|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
1195802|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
1195803|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
1195804|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
1195805|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
1195806|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
1195807|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
1195808|NCT00312377|E2|Reported Event|Placebo Plus Docetaxel|Placebo plus docetaxel
1195809|NCT00312377|E1|Reported Event|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
1195810|NCT00312338|B3|Baseline|Total|Total of all reporting groups
1195811|NCT00312338|B2|Baseline|Healthy Subjects|Healthy Subjects
1195812|NCT00312338|B1|Baseline|Infected Patients|Infected Patients
1195813|NCT00312338|P2|Participant Flow|Healthy Subjects|Healthy Subjects
1195814|NCT00312338|P1|Participant Flow|Infected Patients|Infected Patients
1195815|NCT00312338|O2|Outcome|Healthy Subjects|Healthy Subjects
1195816|NCT00312338|O1|Outcome|Infected Patients|Infected Patients
1195817|NCT00312338|O2|Outcome|Healthy Subjects|Healthy Subjects
1195818|NCT00312338|O1|Outcome|Infected Patients|Infected Patients
1195819|NCT00312338|O2|Outcome|Healthy Subjects|Healthy Subjects
1195820|NCT00312338|O1|Outcome|Infected Patients|Infected Patients
1195821|NCT00312338|E2|Reported Event|Healthy Subjects|Healthy Subjects
1195822|NCT00312338|E1|Reported Event|Infected Patients|Infected Patients
1195823|NCT00312221|B4|Baseline|Total|Total of all reporting groups
1195824|NCT00312221|B3|Baseline|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
1195825|NCT00312221|B2|Baseline|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
1195826|NCT00312221|B1|Baseline|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
1195827|NCT00312221|P4|Participant Flow|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
1196737|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1195828|NCT00312221|P3|Participant Flow|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
1195829|NCT00312221|P2|Participant Flow|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
1195830|NCT00312221|P1|Participant Flow|Run-in Period|The run-in period was designed to select subjects whose pain was adequately controlled by and who tolerated BTDS 20 treatment. BTDS 10 or 20 was applied for 7-day wear during the 3-week run-in period.
1195831|NCT00312221|O3|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
1195832|NCT00312221|O2|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
1195833|NCT00312221|O1|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
1195834|NCT00312221|O3|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
1195835|NCT00312221|O2|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
1195836|NCT00312221|O1|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
1195837|NCT00312221|O3|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
1195838|NCT00312221|O2|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
1195839|NCT00312221|O1|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
1195840|NCT00312221|O3|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
1195841|NCT00312221|O2|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
1195842|NCT00312221|O1|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
1195843|NCT00312221|E4|Reported Event|Run-in, Open-label BTDS 10 and 20|The run-in period was designed to select subjects whose pain was adequately controlled by and who tolerated BTDS 20 treatment. BTDS 10 or 20 was applied for 7-day wear during the 3-week run-in period.
1195844|NCT00312221|E3|Reported Event|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours) during the 12-week double-blind phase.
1195845|NCT00312221|E2|Reported Event|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
1195846|NCT00312221|E1|Reported Event|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear during the 12-week double-blind phase
1195847|NCT00312208|B3|Baseline|Total|Total of all reporting groups
1195848|NCT00312208|B2|Baseline|Docetaxel + Doxorubicin and Cyclophosphamide (TAC)|TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
1195849|NCT00312208|B1|Baseline|Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)|AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
1195850|NCT00312208|P2|Participant Flow|Docetaxel + Doxorubicin and Cyclophosphamide (TAC)|TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
1195851|NCT00312208|P1|Participant Flow|Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)|AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
1195852|NCT00312208|O2|Outcome|Docetaxel + Doxorubicin and Cyclophosphamide (TAC)|TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
1195853|NCT00312208|O1|Outcome|Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)|AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
1195854|NCT00312208|O2|Outcome|Docetaxel + Doxorubicin and Cyclophosphamide (TAC)|TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
1195855|NCT00312208|O1|Outcome|Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)|AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
1195856|NCT00312208|E2|Reported Event|Docetaxel + Doxorubicin and Cyclophosphamide (TAC)|TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
1195857|NCT00312208|E1|Reported Event|Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)|AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
1195858|NCT00312195|B3|Baseline|Total|Total of all reporting groups
1195859|NCT00312195|B2|Baseline|Double-blind BTDS|Test drug - buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear.
1195860|NCT00312195|B1|Baseline|Double-blind Placebo Patch|Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
1195861|NCT00312195|P2|Participant Flow|Double-blind BTDS|Test drug - buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear.
1195862|NCT00312195|P1|Participant Flow|Double-blind Placebo Patch|Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
1195863|NCT00312195|O2|Outcome|Double-blind BTDS|Test drug - buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
1198106|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1195864|NCT00312195|O1|Outcome|Double-blind Placebo Patch|Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
1195865|NCT00312195|O2|Outcome|Double-blind BTDS|Test drug - buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
1195866|NCT00312195|O1|Outcome|Double-blind Placebo Patch|Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
1195867|NCT00312195|O2|Outcome|Double-blind BTDS|Test drug - buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
1195868|NCT00312195|O1|Outcome|Double-blind Placebo Patch|Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
1195869|NCT00312195|O3|Outcome|Total|Placebo and BTDS combined.
1195870|NCT00312195|O2|Outcome|Double-blind BTDS|Test drug - buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
1195871|NCT00312195|O1|Outcome|Double-blind Placebo Patch|Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
1195872|NCT00312195|E3|Reported Event|Open-label Run-in Period BTDS 5, 10 or 20|Buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear.
1196217|NCT00310804|O5|Outcome|TIV Group|Subjects in this group received one dose of Egg-Derived Trivalent Subunit Influenza Vaccine(TIV).
1195873|NCT00312195|E2|Reported Event|Double-blind BTDS|Test drug - buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear.
1195874|NCT00312195|E1|Reported Event|Double-blind Placebo Patch|Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
1195875|NCT00311766|B3|Baseline|Total|Total of all reporting groups
1195876|NCT00311766|B2|Baseline|Thymosin Beta 4|"Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days~Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days"
1195877|NCT00311766|B1|Baseline|Placebo|"Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days~Placebo : Topical administration, 0.00% qd up to 56 days"
1195878|NCT00311766|P2|Participant Flow|Thymosin Beta 4|"Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days~Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days"
1195879|NCT00311766|P1|Participant Flow|Placebo|"Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days~Placebo : Topical administration, 0.00% qd up to 56 days"
1195880|NCT00311766|O2|Outcome|Thymosin Beta 4|"Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days~Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days"
1195881|NCT00311766|O1|Outcome|Placebo|"Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days~Placebo : Topical administration, 0.00% qd up to 56 days"
1195882|NCT00311766|O2|Outcome|Thymosin Beta 4|"Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days~Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days"
1195883|NCT00311766|O1|Outcome|Placebo|"Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days~Placebo : Topical administration, 0.00% qd up to 56 days"
1195884|NCT00311766|E2|Reported Event|Thymosin Beta 4|"Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days~Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days"
1195885|NCT00311766|E1|Reported Event|Placebo|"Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days~Placebo : Topical administration, 0.00% qd up to 56 days"
1195886|NCT00311584|B3|Baseline|Total|Total of all reporting groups
1195887|NCT00311584|B2|Baseline|Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide)|"Measurable by CT scan (Computed Tomography) or MRI scan (Magnetic Resonance Imaging). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV"
1195888|NCT00311584|B1|Baseline|Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide)|"Evaluation by bone marrow or MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV"
1195889|NCT00311584|P2|Participant Flow|Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide)|"Measurable by CT scan (Computed Tomography) or MRI scan (Magnetic Resonance Imaging). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV"
1195890|NCT00311584|P1|Participant Flow|Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide)|"Evaluation by bone marrow or MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical). Patients receive irinotecan hydrochloride IV (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV"
1195891|NCT00311584|O2|Outcome|Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide)|"Measurable by CT scan (Computed Tomography) or MRI scan (Magnetic Resonance Imaging). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV"
1195892|NCT00311584|O1|Outcome|Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide)|"Evaluation by bone marrow or MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV"
1195893|NCT00311584|E2|Reported Event|Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide)|"Measurable by CT scan (Computed Tomography) or MRI scan (Magnetic Resonance Imaging). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV"
1195894|NCT00311584|E1|Reported Event|Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide)|"Evaluation by bone marrow or MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV"
1195895|NCT00311402|B3|Baseline|Total|Total of all reporting groups
1195896|NCT00311402|B2|Baseline|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
1195897|NCT00311402|B1|Baseline|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
1195898|NCT00311402|P2|Participant Flow|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
1195899|NCT00311402|P1|Participant Flow|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
1195900|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
1199163|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
1195901|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
1195902|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
1195903|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
1195904|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
1195905|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
1195906|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
1195907|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
1195908|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
1195909|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
1195910|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
1195911|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
1195912|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
1195913|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
1195914|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
1195915|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
1195916|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
1195917|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
1195918|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
1195919|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
1195920|NCT00311402|E2|Reported Event|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
1195921|NCT00311402|E1|Reported Event|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
1195922|NCT00311376|B4|Baseline|Total|Total of all reporting groups
1195923|NCT00311376|B3|Baseline|Placebo|Normal saline (placebo)
1195924|NCT00311376|B2|Baseline|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
1195925|NCT00311376|B1|Baseline|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
1195926|NCT00311376|P3|Participant Flow|Placebo|Normal saline (placebo)
1195927|NCT00311376|P2|Participant Flow|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
1195928|NCT00311376|P1|Participant Flow|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
1195929|NCT00311376|O3|Outcome|Placebo|Normal saline (placebo)
1195930|NCT00311376|O2|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
1195931|NCT00311376|O1|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
1195932|NCT00311376|O3|Outcome|Placebo|Normal saline (placebo)
1195933|NCT00311376|O2|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
1195934|NCT00311376|O1|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
1195935|NCT00311376|O3|Outcome|Placebo|Normal saline (placebo)
1195936|NCT00311376|O2|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
1195937|NCT00311376|O1|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
1195938|NCT00311376|O3|Outcome|Placebo|Normal saline (placebo)
1195939|NCT00311376|O2|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
1195940|NCT00311376|O1|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
1195941|NCT00311376|E3|Reported Event|Placebo|Normal saline (placebo)
1195942|NCT00311376|E2|Reported Event|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
1195943|NCT00311376|E1|Reported Event|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
1195944|NCT00311363|B4|Baseline|Total|Total of all reporting groups
1195945|NCT00311363|B3|Baseline|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet.
1195946|NCT00311363|B2|Baseline|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet.
1195947|NCT00311363|B1|Baseline|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn).
1195948|NCT00311363|P3|Participant Flow|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet.
1195949|NCT00311363|P2|Participant Flow|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet.
1195950|NCT00311363|P1|Participant Flow|Single-blind (SB) GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn).
1195951|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
1195952|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
1195953|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
1195954|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
1195955|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
1195956|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
1195957|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
1195958|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
1195959|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
1195960|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
1195961|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
1195962|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
1195963|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
1195964|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
1195965|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
1195966|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
1195967|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
1195968|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
1195969|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
1195970|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
1195971|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
1195972|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
1195973|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
1195974|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
1195975|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
1195976|NCT00311363|O2|Outcome|DB GEn 1200mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
1195977|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
1195978|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
1195979|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
1195980|NCT00311363|O2|Outcome|GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
1195981|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
1195982|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
1195983|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
1195984|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
1195985|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
1195986|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
1195987|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
1195988|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
1195989|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
1195990|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
1195991|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
1195992|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
1195993|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
1195994|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
1195995|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
1195996|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
1195997|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
1195998|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
1195999|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
1196000|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
1196001|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
1196002|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
1196003|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
1196004|NCT00311363|E3|Reported Event|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
1196005|NCT00311363|E2|Reported Event|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
1196006|NCT00311363|E1|Reported Event|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
1196007|NCT00311311|B3|Baseline|Total|Total of all reporting groups
1196008|NCT00311311|B2|Baseline|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
1196009|NCT00311311|B1|Baseline|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
1198107|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1196010|NCT00311311|P2|Participant Flow|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to cyclosporine (CsA) (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
1196032|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
1196137|NCT00310817|O2|Outcome|MenACWY-CRM(Ad+) 12-35M12+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 12 months after the first vaccination.
1199164|NCT00301262|O3|Outcome|DB Placebo Week 8|
1196011|NCT00311311|P1|Participant Flow|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 nanogram per milliliter [ng/mL] by 3-6 months post-transplant) plus mycophenolate mofetil (MMF) (greater than or equal to [>=] 500 milligram per day [mg/day]) or mycophenolate sodium (MPS) (>= 360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or azathioprine (AZA) (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
1196012|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
1196013|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
1196014|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
1196015|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
1196016|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
1196017|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
1196018|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
1196019|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
1196020|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
1196092|NCT00310856|O1|Outcome|MenACWY-CRM_6-12 M|Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
1198446|NCT00303667|B3|Baseline|Total|Total of all reporting groups
1196054|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
1196021|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
1196022|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
1196023|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
1196024|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
1196025|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
1196026|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
1196027|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
1196028|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
1196029|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
1196030|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
1196031|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
1196130|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M12+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 12 months after the first vaccination.
1196033|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
1196034|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
1196035|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
1196036|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
1196037|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
1196038|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
1196039|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
1196040|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
1196041|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
1196042|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
1196093|NCT00310856|O2|Outcome|MenACWY-CRM_12 M|Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
1196131|NCT00310817|O4|Outcome|MenACWY-CRM(Ad-) 12-35M6-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 6 months after the first vaccination.
1196095|NCT00310856|O2|Outcome|MenACWY-CRM_12 M|Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
1196096|NCT00310856|O1|Outcome|MenACWY-CRM_6-12 M|Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
1196043|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
1196044|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
1196045|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
1196046|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
1196047|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
1196048|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
1196049|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
1196050|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
1196051|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
1196052|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
1196053|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
1196132|NCT00310817|O3|Outcome|MenACWY-CRM(Ad+) 12-35M6+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 6 months after the first vaccination.
1196055|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
1196056|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
1196057|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
1196058|NCT00311311|E2|Reported Event|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
1196059|NCT00311311|E1|Reported Event|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
1196060|NCT00311181|B1|Baseline|Group 1|
1196061|NCT00311181|P1|Participant Flow|Group 1|
1196062|NCT00311181|O1|Outcome|Group 1|
1196063|NCT00311181|O1|Outcome|Group 1|
1196064|NCT00311181|O1|Outcome|Group 1|
1196065|NCT00311181|E1|Reported Event|Group 1|
1196066|NCT00311155|B1|Baseline|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olemesartan 20 mg to start. Hydrochlorothiazide 12.5 mg and then 25 mg was added, if necessary. If blood pressure goal was still not achieved, amlodipine 5 mg and then 10 mg were added, if needed. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg.
1196067|NCT00311155|P1|Participant Flow|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olemesartan 20 mg to start. Hydrochlorothiazide 12.5 mg and then 25 mg was added, if necessary. If blood pressure goal was still not achieved, amlodipine 5 mg and then 10 mg were added, if needed. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg.
1196068|NCT00311155|O1|Outcome|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
1196069|NCT00311155|O1|Outcome|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
1196070|NCT00311155|O1|Outcome|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
1196094|NCT00310856|O1|Outcome|MenACWY-CRM_6-12 M|Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
1196097|NCT00310856|E3|Reported Event|MenC-CRM_12M_MenACWY-CRM_18M|Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months). Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib- IPV (at 18 months)
1196138|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M6+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 6 months after the first vaccination.
1196071|NCT00311155|O1|Outcome|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
1196072|NCT00311155|O1|Outcome|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
1196073|NCT00311155|O1|Outcome|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
1196074|NCT00311155|E1|Reported Event|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olemesartan 20 mg to start. Hydrochlorothiazide 12.5 mg and then 25 mg was added, if necessary. If blood pressure goal was still not achieved, amlodipine 5 mg and then 10 mg were added, if needed. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg.
1196075|NCT00310856|B4|Baseline|Total|Total of all reporting groups
1196076|NCT00310856|B3|Baseline|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).~Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
1196077|NCT00310856|B2|Baseline|MenACWY-CRM_12 M|Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
1196078|NCT00310856|B1|Baseline|MenACWY-CRM_6-12 M|Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
1196079|NCT00310856|P3|Participant Flow|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose of MenC-CRM (at 12 months of age) and 1 dose of MenACWY-CRM (at 18 months of age).~Subjects also received routine vaccines: 1 dose of PCV7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
1196080|NCT00310856|P2|Participant Flow|MenACWY-CRM_12 M|Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age).
1196081|NCT00310856|P1|Participant Flow|MenACWY-CRM_6-12 M|Subjects received 2 doses of MenACWY-CRM (1 dose at 6 and 12 months of age). Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age).
1196082|NCT00310856|O3|Outcome|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).~Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
1196083|NCT00310856|O2|Outcome|MenACWY-CRM_12 M|Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
1196084|NCT00310856|O1|Outcome|MenACWY-CRM_6-12 M|Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
1196085|NCT00310856|O1|Outcome|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).~Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
1196086|NCT00310856|O1|Outcome|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).~Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
1196087|NCT00310856|O1|Outcome|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).~Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
1196088|NCT00310856|O1|Outcome|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).~Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
1196089|NCT00310856|O1|Outcome|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).~Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
1196090|NCT00310856|O1|Outcome|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).~Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
1196091|NCT00310856|O2|Outcome|MenACWY-CRM_12 M|Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
1196170|NCT00310817|O1|Outcome|MenACWY-CRM(Ad-) (36 to 59 M6-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 169 (6 months after the first vaccination).
1196098|NCT00310856|E2|Reported Event|MenACWY-CRM_12M|Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months)
1196099|NCT00310856|E1|Reported Event|MenACWY-CRM_6-12M|Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months)
1196100|NCT00310817|B5|Baseline|Total|Total of all reporting groups
1196101|NCT00310817|B4|Baseline|MenACWY-PS (36 to 59 Months)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 or day 337.
1196102|NCT00310817|B3|Baseline|MenACWY-CRM(Ad-) 36 to 59 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 169 or day 337.
1196103|NCT00310817|B2|Baseline|MenACWY-CRM(Ad-) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
1196104|NCT00310817|B1|Baseline|MenACWY-CRM(Ad+) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
1196105|NCT00310817|P4|Participant Flow|MenACWY-PS (36 to 59 Months)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY conjugate vaccine without adjuvant on day 169 or day 337.
1196106|NCT00310817|P3|Participant Flow|MenACWY-CRM(Ad-) 36 to 59 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 169 or day 337.
1196107|NCT00310817|P2|Participant Flow|MenACWY-CRM(Ad-) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
1196108|NCT00310817|P1|Participant Flow|MenACWY-CRM(Ad+) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
1196109|NCT00310817|O4|Outcome|MenACWY-PS 36 to 59 Months|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 or day 337.
1196110|NCT00310817|O3|Outcome|MenACWY-CRM(Ad-) 36 to 59 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 169 or day 337.
1196111|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
1196112|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
1196113|NCT00310817|O4|Outcome|MenACWY-PS 36 to 59 Months|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 or day 337.
1196114|NCT00310817|O3|Outcome|MenACWY-CRM(Ad-) 36 to 59 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 169 or day 337.
1196115|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
1196116|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
1196117|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12-35M1-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
1196118|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M1+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
1196119|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12-35M1-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
1196120|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M1+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
1196121|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12-35M1-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
1196122|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M1+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
1196123|NCT00310817|O4|Outcome|MenACWY-CRM(Ad-) 12-35M6-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 6 months after the first vaccination.
1196124|NCT00310817|O3|Outcome|MenACWY-CRM(Ad+) 12-35M6+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 6 months after the first vaccination.
1196125|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12-35M12-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 12 months after the first vaccination.
1196126|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M12+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 12 months after the first vaccination.
1196127|NCT00310817|O4|Outcome|MenACWY-CRM(Ad-) 12-35M6-|Subjects received one dose of MEnACWY-CRM(Ad-) vaccine on day 1 and second dose at 6 months after the first vaccination.
1196128|NCT00310817|O3|Outcome|MenACWY-CRM(Ad+) 12-35M6+|Subjects received one dose of MEnACWY-CRM(Ad+) vaccine on day 1 and second dose at 6 months after the first vaccination.
1196129|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12-35M12-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 12 months after the first vaccination.
1196133|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12-35M12-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 12 months after the first vaccination.
1196134|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M12+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 12 months after the first vaccination.
1196135|NCT00310817|O4|Outcome|MenACWY-CRM(Ad-) 12-35M12-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 12 months after the first vaccination.
1196136|NCT00310817|O3|Outcome|MenACWY-CRM(Ad-) 12-35M6-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 6 months after the first vaccination.
1196216|NCT00310804|O1|Outcome|cTIV_lot 1|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1.
1196139|NCT00310817|O4|Outcome|MenACWY-CRM(Ad-) (12-35M12- )|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 12 months after the first vaccination.
1196140|NCT00310817|O3|Outcome|MenACWY-CRM(Ad-) 12-35M6-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 6 months after the first vaccination.
1196141|NCT00310817|O2|Outcome|MenACWY-CRM(Ad+) 12-35M12+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 12 months after the first vaccination.
1196142|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M6+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 6 months after the first vaccination.
1196143|NCT00310817|O4|Outcome|MenACWY-CRM(Ad-) 12-35M12-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 12 months after the first vaccination.
1196144|NCT00310817|O3|Outcome|MenACWY-CRM(Ad-) 12-35M6-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 6 months after the first vaccination.
1196145|NCT00310817|O2|Outcome|MenACWY-CRM(Ad+) 12-35M12+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 12 months after the first vaccination.
1196146|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M6+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 6 months after the first vaccination.
1196147|NCT00310817|O2|Outcome|MenACWY-CRM (Ad-)12-35M1-|Subjects received one dose of MenACWY-CRM(Ad-)vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
1196148|NCT00310817|O1|Outcome|MenACWY-CRM (Ad+) 12-35M1+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
1196149|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12-35M1-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
1196150|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M1+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
1196151|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12-35M1-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
1196152|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M1+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
1196153|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) (12 to 35 Months)|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
1196154|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) (12 to 35 Months)|Subjects received one dose of MenACWY-CRM(Ad+) vaccine with on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
1196155|NCT00310817|O2|Outcome|MenACWY-CRM( Ad-) (12 to 35 Months)|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
1196156|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) (12 to 35 Months)|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
1196157|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) (12 to 35 Months)|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
1196158|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) (12 to 35 Months)|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
1196159|NCT00310817|O4|Outcome|MenACWY-PS (36-59 M12PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 358 (12 months after first vaccination).
1196160|NCT00310817|O3|Outcome|MenACWY-PS (36-59 M6PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).
1196161|NCT00310817|O2|Outcome|MenACWY-CRM( Ad-) (36 to 59 M12-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 358 (12 months after the first vaccination).
1196162|NCT00310817|O1|Outcome|MenACWY-CRM(Ad-) (36 to 59 M6-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 169 (6 months after the first vaccination).
1196163|NCT00310817|O4|Outcome|MenACWY-PS (36-59 M12PS)|Subjects received one dose of MenACWY PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 358 (12 months after first vaccination).
1196164|NCT00310817|O3|Outcome|MenACWY-PS (36-59 M6PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) on day 169 (6 months after first vaccination).
1196165|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) (36 to 59 M12-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 358 (12 months after the first vaccination).
1196166|NCT00310817|O1|Outcome|MenACWY-CRM(Ad-) (36 to 59 M6-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 169 (6 months after the first vaccination).
1196167|NCT00310817|O4|Outcome|MeMenACWY-PS (36-59 M12PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
1196168|NCT00310817|O3|Outcome|MenACWY-PS (36-59 M6PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).
1196169|NCT00310817|O2|Outcome|MenACWY-CRM( Ad-) (36 to 59 M12-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 358 (12 months after the first vaccination).
1196171|NCT00310817|O4|Outcome|MenACWY-PS (36-59 M12PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
1196172|NCT00310817|O3|Outcome|MenACWY-PS (36-59 M6PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).
1196173|NCT00310817|O2|Outcome|MenACWY-CRM( Ad-) (36 to 59 M12-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 358 (12 months after the first vaccination).
1196174|NCT00310817|O1|Outcome|MenACWY-CRM(Ad-) (36 to 59 M6-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 169 (6 months after the first vaccination).
1196175|NCT00310817|O4|Outcome|MenACWY-PS (36-59 M12PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
1196618|NCT00308737|P3|Participant Flow|Non-diabetes|Subjects without abnormalities in glucose control
1196176|NCT00310817|O3|Outcome|MenACWY-PS (36-59 M6PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).
1196177|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) (36 to 59 M12-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 358 (12 months after the first vaccination).
1196178|NCT00310817|O1|Outcome|MenACWY-CRM(Ad)- (36 to 59 M6-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 169 (6 months after the first vaccination).
1196179|NCT00310817|O4|Outcome|MenACWY-PS (36-59 M12PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
1196180|NCT00310817|O3|Outcome|MenACWY-PS (36-59 M6PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).
1196181|NCT00310817|O2|Outcome|MenACWY-CRM( Ad-) (36 to 59 M12-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 358 (12 months after the first vaccination).
1196182|NCT00310817|O1|Outcome|MenACWY-CRM(Ad-) (36 to 59 M6-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 169 (6 months after the first vaccination).
1196183|NCT00310817|O2|Outcome|MenACWY-PS (36 to 59 Months)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 or day 337.
1196184|NCT00310817|O1|Outcome|MenACWY-CRM(Ad-) (36 to 59 Months)|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.
1196185|NCT00310817|O2|Outcome|MenACWY-PS (36 to 59 Months)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 or day 337.
1196186|NCT00310817|O1|Outcome|MenACWY-CRM(Ad-) (36 to 59 Months)|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337
1196187|NCT00310817|O2|Outcome|MenACWY-PS (36 to 59 Months)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-)vaccine on day 169 or day 337.
1196188|NCT00310817|O1|Outcome|MenACWY-CRM(Ad-) (36 to 59 Months)|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.
1196189|NCT00310817|E4|Reported Event|MenACWY-PS (36 to 59 Months)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY conjugate vaccine without adjuvant on day 169 or day 337.
1196190|NCT00310817|E3|Reported Event|MenACWY-CRM(Ad-) 36 to 59 Months|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 169 or day 337.
1196191|NCT00310817|E2|Reported Event|MenACWY-CRM(Ad-) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad-)vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
1196192|NCT00310817|E1|Reported Event|MenACWY-CRM(Ad+) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad+)vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
1196193|NCT00310804|B3|Baseline|Total|Total of all reporting groups
1196194|NCT00310804|B2|Baseline|TIV Group|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
1196195|NCT00310804|B1|Baseline|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
1196196|NCT00310804|P2|Participant Flow|TIV Group|Subjects in this group received one dose of Egg derived Trivalent Subunit Influenza Vaccine (TIV).
1196197|NCT00310804|P1|Participant Flow|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
1196198|NCT00310804|O4|Outcome|TIV Group Day 23 to Day 181|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
1196199|NCT00310804|O3|Outcome|TIV Group Day 1 to Day 22|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
1196200|NCT00310804|O2|Outcome|cTIV (Combined) Day 23 to Day 181|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
1196201|NCT00310804|O1|Outcome|cTIV (Combined) Day 1 to Day 22|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot 1, Lot2 or Lot3).
1196202|NCT00310804|O5|Outcome|TIV Group|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
1196203|NCT00310804|O4|Outcome|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
1196204|NCT00310804|O3|Outcome|cTIV_lot3|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3.
1196205|NCT00310804|O2|Outcome|cTIV_lot2|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2.
1196206|NCT00310804|O1|Outcome|cTIV_lot1|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1.
1196207|NCT00310804|O5|Outcome|TIV Group|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
1196208|NCT00310804|O4|Outcome|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
1196209|NCT00310804|O3|Outcome|cTIV_lot3|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from lot 3.
1196210|NCT00310804|O2|Outcome|cTIV_lot 2|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2.
1196211|NCT00310804|O1|Outcome|cTIV_lot1|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1.
1196212|NCT00310804|O5|Outcome|TIV Group|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
1196213|NCT00310804|O4|Outcome|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
1196214|NCT00310804|O3|Outcome|cTIV_lot 3|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3.
1196215|NCT00310804|O2|Outcome|cTIV_lot 2|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2.
1196218|NCT00310804|O4|Outcome|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
1196219|NCT00310804|O3|Outcome|cTIV_lot3|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3.
1196220|NCT00310804|O2|Outcome|cTIV_lot 2|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2.
1196221|NCT00310804|O1|Outcome|cTIV_lot1|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1.
1196222|NCT00310804|O5|Outcome|TIV Group|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
1196223|NCT00310804|O4|Outcome|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
1196224|NCT00310804|O3|Outcome|cTIV_lot3|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3.
1196225|NCT00310804|O2|Outcome|cTIV_lot 2|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2
1196226|NCT00310804|O1|Outcome|cTIV_lot1|Subjects in this group received one dose of Cell-Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1.
1196227|NCT00310804|E2|Reported Event|TIV Group|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
1196228|NCT00310804|E1|Reported Event|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
1196229|NCT00310791|B3|Baseline|Total|Total of all reporting groups
1196230|NCT00310791|B2|Baseline|Active|
1196231|NCT00310791|B1|Baseline|Placebo|
1196232|NCT00310791|P2|Participant Flow|Active|
1196233|NCT00310791|P1|Participant Flow|Placebo|
1196234|NCT00310791|O2|Outcome|Active|DHEA+HRT
1196235|NCT00310791|O1|Outcome|Placebo|Sugar Pill
1196236|NCT00310791|E2|Reported Event|Active|
1196237|NCT00310791|E1|Reported Event|Placebo|
1196238|NCT00310466|B3|Baseline|Total|Total of all reporting groups
1196239|NCT00310466|B2|Baseline|Placebo|Corresponding placebo for sublingual administration
1196240|NCT00310466|B1|Baseline|SLITone Birch|Birch pollen extract for sublingual administration
1196241|NCT00310466|P2|Participant Flow|Placebo|Corresponding placebo for sublingual administration
1196242|NCT00310466|P1|Participant Flow|SLITone Birch|Birch pollen extract for sublingual administration
1196243|NCT00310466|O2|Outcome|Placebo|Corresponding placebo for sublingual administration
1196244|NCT00310466|O1|Outcome|SLITone Birch|Birch pollen extract for sublingual administration
1196245|NCT00310466|O2|Outcome|Placebo|Corresponding placebo for sublingual administration
1196246|NCT00310466|O1|Outcome|SLITone Birch|Birch pollen extract for sublingual administration
1196247|NCT00310466|O2|Outcome|Placebo|Corresponding placebo for sublingual administration
1196248|NCT00310466|O1|Outcome|SLITone Birch|Birch pollen extract for sublingual administration
1196249|NCT00310466|O2|Outcome|Placebo|Corresponding placebo for sublingual administration
1196250|NCT00310466|O1|Outcome|SLITone Birch|Birch pollen extract for sublingual administration
1196251|NCT00310466|E2|Reported Event|Placebo|Corresponding placebo for sublingual administration
1196252|NCT00310466|E1|Reported Event|SLITone Birch|Birch pollen extract for sublingual administration
1196253|NCT00310440|B3|Baseline|Total|Total of all reporting groups
1196254|NCT00310440|B2|Baseline|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
1196255|NCT00310440|B1|Baseline|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
1196256|NCT00310440|P2|Participant Flow|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
1196257|NCT00310440|P1|Participant Flow|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
1196368|NCT00310310|B1|Baseline|Usual Care|"Usual sleep apnea and cpap care~Usual care: Usual sleep apnea and cpap care"
1196258|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
1196259|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
1196260|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
1196490|NCT00309608|O4|Outcome|Linagliptin 10 mg|Patients randomized to receive treatment with Linagliptin 10 mg
1199165|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
1196261|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
1196262|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
1196263|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
1196264|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
1196265|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
1196266|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
1196267|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
1196268|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
1196269|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
1196270|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
1196271|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
1196272|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
1196273|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
1196274|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
1196275|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
1196370|NCT00310310|P1|Participant Flow|Usual Care|"Usual sleep apnea and cpap care~Usual care: Usual sleep apnea and cpap care"
1196276|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
1196277|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
1196278|NCT00310440|E2|Reported Event|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
1196279|NCT00310440|E1|Reported Event|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
1196280|NCT00310427|B3|Baseline|Total|Total of all reporting groups
1196281|NCT00310427|B2|Baseline|Placebo|Subjects received placebo orally on a daily basis.
1196282|NCT00310427|B1|Baseline|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
1196283|NCT00310427|P2|Participant Flow|Placebo|Subjects received placebo orally on a daily basis.
1196284|NCT00310427|P1|Participant Flow|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
1196285|NCT00310427|O2|Outcome|Placebo|Subjects received placebo orally on a daily basis.
1196286|NCT00310427|O1|Outcome|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
1196287|NCT00310427|O2|Outcome|Placebo|Subjects received placebo orally on a daily basis.
1196288|NCT00310427|O1|Outcome|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
1196289|NCT00310427|O2|Outcome|Placebo|Subjects received placebo orally on a daily basis.
1196290|NCT00310427|O1|Outcome|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
1196291|NCT00310427|O2|Outcome|Placebo|Subjects received placebo orally on a daily basis.
1196292|NCT00310427|O1|Outcome|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
1196293|NCT00310427|O2|Outcome|Placebo|Subjects received placebo orally on a daily basis.
1196294|NCT00310427|O1|Outcome|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
1196295|NCT00310427|O2|Outcome|Placebo|Subjects received placebo orally on a daily basis.
1196296|NCT00310427|O1|Outcome|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
1196297|NCT00310427|O2|Outcome|Placebo|Subjects received placebo orally on a daily basis.
1196298|NCT00310427|O1|Outcome|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
1196299|NCT00310427|O2|Outcome|Placebo|Subjects received placebo orally on a daily basis.
1196300|NCT00310427|O1|Outcome|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
1196301|NCT00310427|E2|Reported Event|Placebo|Subjects received placebo orally on a daily basis.
1196302|NCT00310427|E1|Reported Event|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
1196303|NCT00310401|B3|Baseline|Total|Total of all reporting groups
1196304|NCT00310401|B2|Baseline|Saline|
1196305|NCT00310401|B1|Baseline|Albuterol|
1196306|NCT00310401|P2|Participant Flow|Saline|
1196307|NCT00310401|P1|Participant Flow|Albuterol|
1196308|NCT00310401|O2|Outcome|Saline|
1196309|NCT00310401|O1|Outcome|Albuterol|
1196310|NCT00310401|E2|Reported Event|Saline|
1196311|NCT00310401|E1|Reported Event|Albuterol|
1196312|NCT00310375|B3|Baseline|Total|Total of all reporting groups
1196313|NCT00310375|B2|Baseline|Retigabine in Parent Study|
1196314|NCT00310375|B1|Baseline|Placebo in Parent Study|
1196315|NCT00310375|P2|Participant Flow|Retigabine in Parent Study|Participants received retigabine tablets as a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation until withdrawal, withdrawn consent or switched to commercial product. Participants who received retigabine in parent study are included in this arm.
1196316|NCT00310375|P1|Participant Flow|Placebo in Parent Study|Participants received retigabine tablets as a total dose of between 600 to 1200 mg/day (dose administered twice daily or Thrice daily [TID]) as an adjunct therapy to their ongoing antiepileptic drugs (AEDs) with or without vagal nerve stimulation (VNS) until withdrawal, withdrawn consent or switched to commercial product. Participants who received placebo in parent study are included in this arm.
1196317|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196318|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196319|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196369|NCT00310310|P2|Participant Flow|Self-Management|"sleep apnea self-management program - 4 sessions, group-based~Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
1196320|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196321|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196322|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196491|NCT00309608|O3|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5 mg
1196323|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196324|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196325|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196326|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196327|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196328|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196329|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196330|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196331|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196332|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196333|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196334|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196335|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196336|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196337|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196338|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196339|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196340|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196341|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196342|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196343|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196344|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196345|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196346|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196347|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196348|NCT00310375|O1|Outcome|Overall Study|
1196349|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196350|NCT00310375|O1|Outcome|Overall Study|
1196351|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196352|NCT00310375|E1|Reported Event|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
1196353|NCT00310362|B4|Baseline|Total|Total of all reporting groups
1196354|NCT00310362|B3|Baseline|IVR7|Arm 3 (IVR7) included interactive voice response calls delivered to patients 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
1196355|NCT00310362|B2|Baseline|IVR3|Arm 2 (IVR3) included interactive voice response calls delivered to patients 3 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures..
1196356|NCT00310362|B1|Baseline|Usual Care|Usual Care--Nurses telephoned patients 7 days prior to appointment to remind patients about scheduled GI appointment and to answer any questions.
1196357|NCT00310362|P3|Participant Flow|IVR7|Arm 3 (IVR7) included interactive voice response calls delivered to patients 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
1196358|NCT00310362|P2|Participant Flow|IVR3|Arm 2 (IVR3) included interactive voice response calls delivered to patients 3 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
1196359|NCT00310362|P1|Participant Flow|Usual Care|Usual care included nurse phone calls to participants 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and opportunities for education on preparation procedures.
1196360|NCT00310362|O3|Outcome|IVR7|Arm 3 (IVR7) included interactive voice response calls delivered to patients 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
1196361|NCT00310362|O2|Outcome|IVR3|Arm 2 (IVR3) included interactive voice response calls delivered to patients 3 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
1196362|NCT00310362|O1|Outcome|Usual Care|Usual care included nurse phone calls to participants 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and opportunities for education on preparation procedures.
1196363|NCT00310362|E3|Reported Event|IVR7|Arm 2 (IVR3) included interactive voice response calls delivered to patients 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
1196364|NCT00310362|E2|Reported Event|IVR3|Arm 2 (IVR3) included interactive voice response calls delivered to patients 3 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
1196365|NCT00310362|E1|Reported Event|Usual Care|Usual Care--Nurses telephoned patients 7 days prior to appointment to remind patients about scheduled GI appointment and to answer any questions.
1196366|NCT00310310|B3|Baseline|Total|Total of all reporting groups
1196367|NCT00310310|B2|Baseline|Self-Management|"sleep apnea self-management program - 4 sessions, group-based~Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
1196371|NCT00310310|O2|Outcome|Self-Management|"sleep apnea self-management program - 4 sessions, group-based~Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
1196372|NCT00310310|O1|Outcome|Usual Care|"Usual sleep apnea and cpap care~Usual care: Usual sleep apnea and cpap care"
1196373|NCT00310310|O2|Outcome|Self-Management|"sleep apnea self-management program - 4 sessions, group-based~Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
1196374|NCT00310310|O1|Outcome|Usual Care|"Usual sleep apnea and cpap care~Usual care: Usual sleep apnea and cpap care"
1196375|NCT00310310|O2|Outcome|Self-Management|"sleep apnea self-management program - 4 sessions, group-based~Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
1196376|NCT00310310|O1|Outcome|Usual Care|"Usual sleep apnea and cpap care~Usual care: Usual sleep apnea and cpap care"
1196377|NCT00310310|O2|Outcome|Self-Management|"sleep apnea self-management program - 4 sessions, group-based~Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
1196378|NCT00310310|O1|Outcome|Usual Care|"Usual sleep apnea and cpap care~Usual care: Usual sleep apnea and cpap care"
1196379|NCT00310310|O2|Outcome|Self-Management|"sleep apnea self-management program - 4 sessions, group-based~Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
1196380|NCT00310310|O1|Outcome|Usual Care|"Usual sleep apnea and cpap care~Usual care: Usual sleep apnea and cpap care"
1196381|NCT00310310|O2|Outcome|Self-Management|"sleep apnea self-management program - 4 sessions, group-based~Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
1196382|NCT00310310|O1|Outcome|Usual Care|"Usual sleep apnea and cpap care~Usual care: Usual sleep apnea and cpap care"
1196383|NCT00310310|O2|Outcome|Self-Management|"sleep apnea self-management program - 4 sessions, group-based~Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
1196384|NCT00310310|O1|Outcome|Usual Care|"Usual sleep apnea and cpap care~Usual care: Usual sleep apnea and cpap care"
1196385|NCT00310310|O2|Outcome|Self-Management|"sleep apnea self-management program - 4 sessions, group-based~Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
1196386|NCT00310310|O1|Outcome|Usual Care|"Usual sleep apnea and cpap care~Usual care: Usual sleep apnea and cpap care"
1196387|NCT00310310|O2|Outcome|Self-Management|"sleep apnea self-management program - 4 sessions, group-based~Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
1196388|NCT00310310|O1|Outcome|Usual Care|"Usual sleep apnea and cpap care~Usual care: Usual sleep apnea and cpap care"
1196389|NCT00310310|O2|Outcome|Self-Management|"sleep apnea self-management program - 4 sessions, group-based~Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
1196390|NCT00310310|O1|Outcome|Usual Care|"Usual sleep apnea and cpap care~Usual care: Usual sleep apnea and cpap care"
1196391|NCT00310310|E2|Reported Event|Self-Management|"sleep apnea self-management program - 4 sessions, group-based~Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based."
1196392|NCT00310310|E1|Reported Event|Usual Care|"Usual sleep apnea and cpap care~Usual care: Usual sleep apnea and cpap care"
1196393|NCT00310076|B1|Baseline|Chemo Therapy Followed by Thalidomide|After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
1196394|NCT00310076|P1|Participant Flow|Chemo Therapy Followed by Thalidomide|After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
1196395|NCT00310076|O1|Outcome|Chemo Therapy Followed by Thalidomide|After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
1196396|NCT00310076|E1|Reported Event|Chemo Therapy Followed by Thalidomide|After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
1196397|NCT00309985|B3|Baseline|Total|Total of all reporting groups
1196398|NCT00309985|B2|Baseline|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
1196399|NCT00309985|B1|Baseline|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
1196400|NCT00309985|P2|Participant Flow|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
1196401|NCT00309985|P1|Participant Flow|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
1196402|NCT00309985|O2|Outcome|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
1196403|NCT00309985|O1|Outcome|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
1196404|NCT00309985|O2|Outcome|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
1198680|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
1196405|NCT00309985|O1|Outcome|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
1196406|NCT00309985|O2|Outcome|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
1196407|NCT00309985|O1|Outcome|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
1196408|NCT00309985|O2|Outcome|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
1196409|NCT00309985|O1|Outcome|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
1196410|NCT00309985|O2|Outcome|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
1196411|NCT00309985|O1|Outcome|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
1196412|NCT00309985|O2|Outcome|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
1196413|NCT00309985|O1|Outcome|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
1196414|NCT00309985|E2|Reported Event|Arm B|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
1196415|NCT00309985|E1|Reported Event|Arm A|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
1196416|NCT00309946|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
1196417|NCT00309946|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
1196418|NCT00309946|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
1196419|NCT00309946|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
1196420|NCT00309946|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
1196421|NCT00309946|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
1196422|NCT00309907|B1|Baseline|Etanercept and Corticosteroid Therapy|"Patients receive etanercept IV (dose 0.4 mg/kg- max 25 mg) over 30 minutes on day 0 and subcutaneously (dose 0.4 mg/kg- max 25 mg) on days 3, 7, 10, 14, 17, 21, and 24. Treatment continues in the absence of an infectious pathogen, disease progression, or unacceptable toxicity. Patients also receive methylprednisolone (or corticosteroid equivalent) IV (dose 2.0 mg/kg/day) on days 0-2 and then orally with a taper beginning day 7. Dose on days 7-20 (1.0 mg/kg/day), days 21-34 (0.5 mg/kg/day), days 35-48 (0.25 mg/kg/day) and days 49-56 (0.25 mg/kg/every other day) discontinuing on day 56.~etanercept: Given IV and subcutaneously~methylprednisolone: Given IV and orally"
1196423|NCT00309907|P1|Participant Flow|Etanercept and Corticosteroid Therapy|"Patients receive etanercept IV (dose 0.4 mg/kg- max 25 mg) over 30 minutes on day 0 and subcutaneously (dose 0.4 mg/kg- max 25 mg) on days 3, 7, 10, 14, 17, 21, and 24. Treatment continues in the absence of an infectious pathogen, disease progression, or unacceptable toxicity. Patients also receive methylprednisolone (or corticosteroid equivalent) IV (dose 2.0 mg/kg/day) on days 0-2 and then orally with a taper beginning day 7. Dose on days 7-20 (1.0 mg/kg/day), days 21-34 (0.5 mg/kg/day), days 35-48 (0.25 mg/kg/day) and days 49-56 (0.25 mg/kg/every other day) discontinuing on day 56.~etanercept: Given IV and subcutaneously~methylprednisolone: Given IV and orally"
1196482|NCT00309608|O2|Outcome|Linagliptin 1 mg|Patients randomized to receive treatment with Linagliptin 1 mg
1196483|NCT00309608|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1199114|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
1196424|NCT00309907|O1|Outcome|Etanercept and Corticosteroid Therapy|"Patients receive etanercept IV (dose 0.4 mg/kg- max 25 mg) over 30 minutes on day 0 and subcutaneously (dose 0.4 mg/kg- max 25 mg) on days 3, 7, 10, 14, 17, 21, and 24. Treatment continues in the absence of an infectious pathogen, disease progression, or unacceptable toxicity. Patients also receive methylprednisolone (or corticosteroid equivalent) IV (dose 2.0 mg/kg/day) on days 0-2 and then orally with a taper beginning day 7. Dose on days 7-20 (1.0 mg/kg/day), days 21-34 (0.5 mg/kg/day), days 35-48 (0.25 mg/kg/day) and days 49-56 (0.25 mg/kg/every other day) discontinuing on day 56.~etanercept: Given IV and subcutaneously~methylprednisolone: Given IV and orally"
1196492|NCT00309608|O2|Outcome|Linagliptin 1 mg|Patients randomized to receive treatment with Linagliptin 1 mg
1196493|NCT00309608|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1196494|NCT00309608|E5|Reported Event|Glimepiride|Patients randomized to receive treatment with Glimepiride
1196425|NCT00309907|E1|Reported Event|Etanercept and Corticosteroid Therapy|"Patients receive etanercept IV (dose 0.4 mg/kg- max 25 mg) over 30 minutes on day 0 and subcutaneously (dose 0.4 mg/kg- max 25 mg) on days 3, 7, 10, 14, 17, 21, and 24. Treatment continues in the absence of an infectious pathogen, disease progression, or unacceptable toxicity. Patients also receive methylprednisolone (or corticosteroid equivalent) IV (dose 2.0 mg/kg/day) on days 0-2 and then orally with a taper beginning day 7. Dose on days 7-20 (1.0 mg/kg/day), days 21-34 (0.5 mg/kg/day), days 35-48 (0.25 mg/kg/day) and days 49-56 (0.25 mg/kg/every other day) discontinuing on day 56.~etanercept: Given IV and subcutaneously~methylprednisolone: Given IV and orally"
1196426|NCT00309777|B5|Baseline|Total|Total of all reporting groups
1196427|NCT00309777|B4|Baseline|Simvastatin 40 mg|Simvastatn 40 mg once daily
1196428|NCT00309777|B3|Baseline|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
1196429|NCT00309777|B2|Baseline|Simvastatin 20 mg|Simvastatin 20 mg once daily
1196430|NCT00309777|B1|Baseline|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
1196431|NCT00309777|P4|Participant Flow|Simvastatin 40 mg|Simvastatn 40 mg once daily
1196432|NCT00309777|P3|Participant Flow|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
1196433|NCT00309777|P2|Participant Flow|Simvastatin 20 mg|Simvastatin 20 mg once daily
1196434|NCT00309777|P1|Participant Flow|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
1196435|NCT00309777|O4|Outcome|Simvastatin 40 mg|Simvastatn 40 mg once daily
1196436|NCT00309777|O3|Outcome|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
1196437|NCT00309777|O2|Outcome|Simvastatin 20 mg|Simvastatin 20 mg once daily
1196438|NCT00309777|O1|Outcome|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
1196439|NCT00309777|O4|Outcome|Simvastatin 40 mg|Simvastatn 40 mg once daily
1196440|NCT00309777|O3|Outcome|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
1196441|NCT00309777|O2|Outcome|Simvastatin 20 mg|Simvastatin 20 mg once daily
1196442|NCT00309777|O1|Outcome|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
1196443|NCT00309777|E4|Reported Event|Simvastatin 40 mg|Simvastatn 40 mg once daily
1196444|NCT00309777|E3|Reported Event|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
1196445|NCT00309777|E2|Reported Event|Simvastatin 20 mg|Simvastatin 20 mg once daily
1196446|NCT00309777|E1|Reported Event|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
1196447|NCT00309751|B3|Baseline|Total|Total of all reporting groups
1196448|NCT00309751|B2|Baseline|Atorvastatin 20 mg QD|Atorvastatin 20 mg once daily
1196449|NCT00309751|B1|Baseline|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
1196450|NCT00309751|P2|Participant Flow|Atorvastatin 20 mg QD|Atorvastatin 20 mg once daily
1196451|NCT00309751|P1|Participant Flow|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
1196452|NCT00309751|O2|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg once daily
1196453|NCT00309751|O1|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
1196454|NCT00309751|O2|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg once daily
1196455|NCT00309751|O1|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
1196456|NCT00309751|E2|Reported Event|Atorvastatin 20 mg QD|Atorvastatin 20 mg once daily
1196457|NCT00309751|E1|Reported Event|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
1196458|NCT00309738|B3|Baseline|Total|Total of all reporting groups
1196459|NCT00309738|B2|Baseline|Simvastatin 40 mg QD|Simvastatin 40 mg once daily
1196460|NCT00309738|B1|Baseline|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
1196461|NCT00309738|P2|Participant Flow|Simvastatin 40 mg QD|Simvastatin 40 mg once daily
1196462|NCT00309738|P1|Participant Flow|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
1196463|NCT00309738|O2|Outcome|Simvastatin 40 mg QD|Simvastatin 40 mg once daily
1196464|NCT00309738|O1|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
1196465|NCT00309738|O2|Outcome|Simvastatin 40 mg QD|Simvastatin 40 mg once daily
1196466|NCT00309738|O1|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
1196467|NCT00309738|E2|Reported Event|Simvastatin 40 mg QD|Simvastatin 40 mg once daily
1196468|NCT00309738|E1|Reported Event|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
1196469|NCT00309608|B6|Baseline|Total|Total of all reporting groups
1196470|NCT00309608|B5|Baseline|Glimepiride|Patients randomized to receive treatment with Glimepiride
1196471|NCT00309608|B4|Baseline|Linagliptin 10 mg|Patients randomized to receive treatment with Linagliptin 10 mg
1196472|NCT00309608|B3|Baseline|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5 mg
1196473|NCT00309608|B2|Baseline|Linagliptin 1 mg|Patients randomized to receive treatment with Linagliptin 1 mg
1196474|NCT00309608|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
1196475|NCT00309608|P5|Participant Flow|Glimepiride|Patients randomized to receive treatment with Glimepiride
1196476|NCT00309608|P4|Participant Flow|Linagliptin 10 mg|Patients randomized to receive treatment with Linagliptin 10 mg
1196477|NCT00309608|P3|Participant Flow|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5 mg
1196478|NCT00309608|P2|Participant Flow|Linagliptin 1 mg|Patients randomized to receive treatment with Linagliptin 1 mg
1196479|NCT00309608|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
1196480|NCT00309608|O4|Outcome|Linagliptin 10 mg|Patients randomized to receive treatment with Linagliptin 10 mg
1196481|NCT00309608|O3|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5 mg
1199115|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
1196485|NCT00309608|O4|Outcome|Linagliptin 10 mg|Patients randomized to receive treatment with Linagliptin 10 mg
1196486|NCT00309608|O3|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5 mg
1196487|NCT00309608|O2|Outcome|Linagliptin 1 mg|Patients randomized to receive treatment with Linagliptin 1 mg
1196488|NCT00309608|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1196489|NCT00309608|O5|Outcome|Glimepiride|Patients randomized to receive treatment with Glimepiride
1199166|NCT00301262|O1|Outcome|DB Viagra Week 8|
1196495|NCT00309608|E4|Reported Event|Linagliptin 10 mg|Patients randomized to receive treatment with Linagliptin 10 mg
1196496|NCT00309608|E3|Reported Event|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5 mg
1196497|NCT00309608|E2|Reported Event|Linagliptin 1 mg|Patients randomized to receive treatment with Linagliptin 1 mg
1196498|NCT00309608|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
1196499|NCT00309465|B7|Baseline|Total|Total of all reporting groups
1196500|NCT00309465|B6|Baseline|Dose Table (Insulin Glargine Plus Bolus Group)|Subjects were instructed to self administer: (a) 80% of the usual insulin glargine dose if the midpoint of self-reported usual fasting blood glucose range was <150 mg/dl or (b) 100% of the usual insulin glargine dose if the midpoint of the self-reported usual fasting blood glucose range was > or = 150 mg/dl.
1196501|NCT00309465|B5|Baseline|Call Physician (Insulin Glargine Plus Bolus Group|Subjects were instructed to call their own physician for the insulin glargine dose to administer the evening before surgery.
1196502|NCT00309465|B4|Baseline|Take 80% (Insulin Glargine Plus Bolus Group)|Subjects were instructed to self-administer 80% of the usual insulin glargine dose the evening before surgery
1196503|NCT00309465|B3|Baseline|Dose Table (Insulin Glargine Only Group)|Subjects were instructed to self-administer: (a) 50% of their usual insulin glargine if the midpoint of their usual self-reported fasting blood glucose range was < 150 mg/dl or (b) 80% of their usual insulin glargine if the midpoint of their usual fasting blood glucose range was > or = 150 mg/dl.
1196504|NCT00309465|B2|Baseline|Call Physician (Insulin Glargine Only Group)|Subjects were instructed to call their physician for the insulin glargine dose to administer the evening before surgery.
1196505|NCT00309465|B1|Baseline|Take 80% (Insulin Glargine Only Group)|Subjects were instructed to self-administer 80% of the usual insulin glargine dose on the evening before surgery.
1196506|NCT00309465|P6|Participant Flow|Dose Table (Insulin Glargine Plus Bolus Group)|Subjects were instructed to self-administer: (a) 80% of the usual insulin glargine dose if the midpoint of self-reported usual fasting blood glucose value was <150 mg/dl or (b) 100% of the usual insulin glargine dose if the midpoint of the self-reported usual fasting blood glucose range was > or = 150 mg/dl.
1196507|NCT00309465|P5|Participant Flow|Call Physician (Insulin Glargine Plus Bolus Group|Subjects were instructed to call their own physician for the insulin glargine dose to administer the evening before surgery.
1196508|NCT00309465|P4|Participant Flow|Take 80% (Insulin Glargine Plus Bolus Group)|Subjects were instructed to self-administer 80% of the usual insulin glargine dose the evening before surgery
1196509|NCT00309465|P3|Participant Flow|Dose Table (Insulin Glargine Only Group)|Subjects were instructed to self-administer: (a) 50% of their usual insulin glargine if the midpoint of their usual self-reported fasting blood glucose value was < 150 mg/dl or (b) 80% of their usual insulin glargine if the midpoint of their usual self-reported fasting blood glucose range was > or = 150 mg/dl.
1196510|NCT00309465|P2|Participant Flow|Call Physician (Insulin Glargine Only Group)|Subjects were instructed to call their own physician for the insulin glargine dose to administer the evening before surgery.
1196511|NCT00309465|P1|Participant Flow|Take 80% (Insulin Glargine Only Group)|Subjects were instructed to self-administer 80% of the usual insulin glargine dose on the evening before surgery.
1196512|NCT00309465|O6|Outcome|Dose Table (Insulin Glargine Plus Bolus Group)|Subjects administered: (a) 80% of their usual insulin glargine dose if the midpoint of self-reported usual fasting blood glucose range was <150 mg/dl or (b) 100% of their usual insulin glargine dose if midpoint of self-reported usual fasting blood glucose ragne was > or = 150 mg/dl
1196513|NCT00309465|O5|Outcome|Call Physician (Insulin Glargine Plus Bolus Group|Subjects called their own physicians for the insulin glargine dose to administer on the evening before surgery
1196514|NCT00309465|O4|Outcome|Take 80% (Insulin Glargine Plus Bolus Group)|Subjects self-administered 80% of the usual insulin glargine dose on the evening before surgery
1196515|NCT00309465|O3|Outcome|Dose Table (Insulin Glargine Only Group)|Subjects administered: (a) 50% of their usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose range was <150 mg/dl or (b) 80% of usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose range was > or = 150 mg/dl
1196516|NCT00309465|O2|Outcome|Call Physician (Insulin Glargine Only Group)|Subjects called their own physicians for insulin glargine dose on the evening before surgery
1196517|NCT00309465|O1|Outcome|Take 80% (Insulin Glargine Only Group)|Subjects self-administered 80% of usual insulin glargine dose on the evening before surgery
1196518|NCT00309465|E6|Reported Event|Dose Table (Insulin Glargine Plus Bolus Group)|Subjects administered: (a) 80% of usual insulin glargine if midpoint of usual self-reported fasting blood glucose was <150 mg/dl or (b) 100% of usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose was < or =150 mg/dl.
1196519|NCT00309465|E5|Reported Event|Call Physician (Insulin Glargine Plus Bolus Group)|Subjects called physician for the insulin glargine dose to administer on the evening before surgery.
1196520|NCT00309465|E4|Reported Event|Take 80% (Insuling Glargine Plus Bolus Group)|Subjects self-administered 80% of usual insulin glargine dose on the evening before surgery
1196589|NCT00309244|O2|Outcome|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
1199116|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
1196521|NCT00309465|E3|Reported Event|Dose Table (Insulin Glargine Only Group)|Subjects administered: (a) 50% of usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose <150 mg/dl or (b) 80% of usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose > or =150 mg/dl
1196522|NCT00309465|E2|Reported Event|Call Physician (Insulin Glargine Only Group)|Subjects called physician for the insulin glargine dose on the evening before surgery.
1196523|NCT00309465|E1|Reported Event|Take 80% (Insulin Glargine Only Group)|Subjects self-administered 80% of usual insulin glargine dose on the evening before surgery
1196524|NCT00309452|B3|Baseline|Total|Total of all reporting groups
1196536|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
1199212|NCT00301262|O3|Outcome|DB Placebo Week 8|
1196525|NCT00309452|B2|Baseline|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
1196526|NCT00309452|B1|Baseline|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
1196527|NCT00309452|P2|Participant Flow|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
1196528|NCT00309452|P1|Participant Flow|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
1196529|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
1196530|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
1196531|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
1196532|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
1196533|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
1196534|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
1196590|NCT00309244|O1|Outcome|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
1196591|NCT00309244|O2|Outcome|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
1196592|NCT00309244|O1|Outcome|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
1196593|NCT00309244|E2|Reported Event|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
1196594|NCT00309244|E1|Reported Event|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
1196535|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
1196537|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
1196538|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
1196539|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
1196540|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
1196541|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
1196542|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
1196543|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
1196544|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
1196545|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
1196546|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
1196595|NCT00308997|B3|Baseline|Total|Total of all reporting groups
1196673|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
1196547|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
1196548|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
1196549|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
1196550|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
1196551|NCT00309452|E2|Reported Event|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
1196552|NCT00309452|E1|Reported Event|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
1196553|NCT00309387|B3|Baseline|Total|Total of all reporting groups
1196554|NCT00309387|B2|Baseline|Placebo|
1196555|NCT00309387|B1|Baseline|Treatment|
1196556|NCT00309387|P2|Participant Flow|Placebo|
1196557|NCT00309387|P1|Participant Flow|Treatment|
1196558|NCT00309387|O2|Outcome|Placebo|Placebo
1196559|NCT00309387|O1|Outcome|Treatment|Centrum
1196560|NCT00309387|O2|Outcome|Placebo|Placebo
1196561|NCT00309387|O1|Outcome|Treatment|Centrum
1196562|NCT00309387|O2|Outcome|Placebo|Placebo
1196563|NCT00309387|O1|Outcome|Treatment|Centrum
1196564|NCT00309387|O2|Outcome|Placebo|placebo
1196565|NCT00309387|O1|Outcome|Treatment|Centrum
1196566|NCT00309387|O2|Outcome|Placebo|Placebo
1196567|NCT00309387|O1|Outcome|Treatment|Centrum
1196568|NCT00309387|O2|Outcome|Placebo|Placebo
1196569|NCT00309387|O1|Outcome|Treatment|Centrum
1196570|NCT00309387|E2|Reported Event|Placebo|
1196571|NCT00309387|E1|Reported Event|Treatment|
1196572|NCT00309244|B3|Baseline|Total|Total of all reporting groups
1196573|NCT00309244|B2|Baseline|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
1196574|NCT00309244|B1|Baseline|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
1196575|NCT00309244|P2|Participant Flow|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart subcutaneous injection (rDNA origin), administered twice daily (before breakfast and before main evening meal). Doses are individualized for each patient.
1196576|NCT00309244|P1|Participant Flow|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder (administered at each meal) + subcutaneous insulin glargine (administered once daily at bedtime). Doses are individualized for each patient.
1196577|NCT00309244|O2|Outcome|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
1196578|NCT00309244|O1|Outcome|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
1196579|NCT00309244|O2|Outcome|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
1196580|NCT00309244|O1|Outcome|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
1196581|NCT00309244|O2|Outcome|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
1196582|NCT00309244|O1|Outcome|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
1196583|NCT00309244|O2|Outcome|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
1196584|NCT00309244|O1|Outcome|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
1196585|NCT00309244|O2|Outcome|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
1196586|NCT00309244|O1|Outcome|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
1196587|NCT00309244|O2|Outcome|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
1196588|NCT00309244|O1|Outcome|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
1196596|NCT00308997|B2|Baseline|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area~1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
1196597|NCT00308997|B1|Baseline|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area~Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
1196614|NCT00308737|B4|Baseline|Total|Total of all reporting groups
1196615|NCT00308737|B3|Baseline|Non-diabetes|Subjects without abnormalities in glucose control
1196616|NCT00308737|B2|Baseline|Usual Care|Usual care
1196598|NCT00308997|P2|Participant Flow|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area~1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
1196599|NCT00308997|P1|Participant Flow|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area~Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
1196600|NCT00308997|O2|Outcome|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area~1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
1196601|NCT00308997|O1|Outcome|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area~Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
1196602|NCT00308997|O2|Outcome|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area~1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
1196603|NCT00308997|O1|Outcome|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area~Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
1196604|NCT00308997|O2|Outcome|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area~1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
1196605|NCT00308997|O1|Outcome|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area~Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
1196606|NCT00308997|O2|Outcome|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area~1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
1196607|NCT00308997|O1|Outcome|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area~Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
1196608|NCT00308997|O2|Outcome|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area~1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
1196609|NCT00308997|O1|Outcome|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area~Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
1196610|NCT00308997|O2|Outcome|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area~1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
1196611|NCT00308997|O1|Outcome|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area~Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
1196612|NCT00308997|E2|Reported Event|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area~1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
1196613|NCT00308997|E1|Reported Event|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area~Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
1196619|NCT00308737|P2|Participant Flow|Usual Care|Usual care may consist of oral anti-diabetic medications, basal insulin, subcutaneous prandial insulin, or any combination of the previous.
1196620|NCT00308737|P1|Participant Flow|Technosphere® Insulin|Technosphere Insulin with or without basal insulin, or oral anti-diabetic medications, or any combination of the previous.
1196621|NCT00308737|O2|Outcome|Usual Care|Usual care
1196622|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
1196623|NCT00308737|O3|Outcome|Non-diabetes|Subjects without abnormalities in glucose control
1196624|NCT00308737|O2|Outcome|Usual Care|Usual care
1196625|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
1196626|NCT00308737|O2|Outcome|Usual Care|Usual care
1196627|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
1196628|NCT00308737|O3|Outcome|Non-diabetes|Subjects without abnormalities in glucose control
1196629|NCT00308737|O2|Outcome|Usual Care|Usual care
1196630|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
1196631|NCT00308737|O3|Outcome|Non-diabetes|Subjects without abnormalities in glucose control
1196632|NCT00308737|O2|Outcome|Usual Care|Usual care
1196633|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
1196634|NCT00308737|O3|Outcome|Non-diabetes|Subjects without abnormalities in glucose control
1196635|NCT00308737|O2|Outcome|Usual Care|Usual care
1196636|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
1196637|NCT00308737|O3|Outcome|Non-diabetes|Subjects without abnormalities in glucose control
1196638|NCT00308737|O2|Outcome|Usual Care|Usual care
1196639|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
1196640|NCT00308737|O3|Outcome|Non-diabetes|Subjects without abnormalities in glucose control
1196641|NCT00308737|O2|Outcome|Usual Care|Usual care
1196642|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
1196643|NCT00308737|O3|Outcome|Non-diabetes|Subjects without abnormalities in glucose control
1196644|NCT00308737|O2|Outcome|Usual Care|Usual care
1196645|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
1196646|NCT00308737|O3|Outcome|Non-diabetes|Subjects without abnormalities in glucose control
1196647|NCT00308737|O2|Outcome|Usual Care|Usual care
1196648|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
1196649|NCT00308737|O2|Outcome|Usual Care|Usual care
1196650|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
1196651|NCT00308737|O2|Outcome|Usual Care|Usual care
1196652|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
1196653|NCT00308737|E3|Reported Event|Non-diabetes|Subjects without abnormalities in glucose control
1196654|NCT00308737|E2|Reported Event|Usual Care|Usual care (taking insulin)
1196655|NCT00308737|E1|Reported Event|Technosphere® Insulin|Technosphere Insulin
1196656|NCT00308711|B4|Baseline|Total|Total of all reporting groups
1196657|NCT00308711|B3|Baseline|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
1196658|NCT00308711|B2|Baseline|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
1196659|NCT00308711|B1|Baseline|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
1196660|NCT00308711|P3|Participant Flow|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
1196661|NCT00308711|P2|Participant Flow|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
1196662|NCT00308711|P1|Participant Flow|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
1196663|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
1196664|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
1196665|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
1196666|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
1196667|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
1196668|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
1196669|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
1196670|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
1196671|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
1196672|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
1196674|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
1196675|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
1196676|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
1196677|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
1196678|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
1196679|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
1196680|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
1196681|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
1196682|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
1196683|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
1196684|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
1196685|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
1196686|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
1196687|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
1196688|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
1196689|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
1196690|NCT00308711|E3|Reported Event|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
1196691|NCT00308711|E2|Reported Event|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
1196692|NCT00308711|E1|Reported Event|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
1196693|NCT00308620|B4|Baseline|Total|Total of all reporting groups
1196694|NCT00308620|B3|Baseline|Chloroquine 250mg|Chloroquine 250mg PO once daily x 8 weeks
1196695|NCT00308620|B2|Baseline|Placebo|Placebo once daily for 8 weeks
1196696|NCT00308620|B1|Baseline|Chloroquine 500mg|Chloroquine 500mg PO once daily x 8 weeks
1196697|NCT00308620|P3|Participant Flow|Chloroquine 250mg|Chloroquine 250mg PO once daily x 8 weeks
1196698|NCT00308620|P2|Participant Flow|Placebo|Placebo once daily for 8 weeks
1196699|NCT00308620|P1|Participant Flow|Chloroquine 500mg|Chloroquine 500mg PO once daily x 8 weeks
1196700|NCT00308620|O2|Outcome|Placebo|Placebo orally once daily for 8 weeks
1196701|NCT00308620|O1|Outcome|Chloroquine 250mg or 500mg|Chloroquine 500mg orally once daily x 8 weeks
1196702|NCT00308620|O2|Outcome|Placebo|Placebo orally once daily for 8 weeks
1196703|NCT00308620|O1|Outcome|Chloroquine 250mg or 500mg|Chloroquine 250mg or 500mg orally once daily x 8 weeks. n=6 for 250mg; n=3 for 500mg
1196704|NCT00308620|E3|Reported Event|Chloroquine 250mg|Chloroquine 250mg PO once daily x 8 weeks
1196705|NCT00308620|E2|Reported Event|Placebo|Placebo once daily for 8 weeks
1196706|NCT00308620|E1|Reported Event|Chloroquine 500mg|Chloroquine 500mg PO once daily x 8 weeks
1196707|NCT00308581|B1|Baseline|Overall|Overall Induction
1196708|NCT00308581|P3|Participant Flow|Overall|Overall Induction
1196709|NCT00308581|P2|Participant Flow|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196710|NCT00308581|P1|Participant Flow|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196711|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196712|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196713|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196714|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196715|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196716|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196717|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196718|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196719|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196720|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196721|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196722|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196723|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196724|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196725|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196726|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196727|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196728|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196729|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196730|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196731|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196732|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196733|NCT00308581|O1|Outcome|Overall|Overall Induction
1196734|NCT00308581|O1|Outcome|Overall|Overall Induction
1196735|NCT00308581|O1|Outcome|Overall|Overall Induction
1196736|NCT00308581|O1|Outcome|Overall|Overall Induction
1196738|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196739|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196740|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196741|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196742|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196743|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196744|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196745|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196746|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196747|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196748|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196749|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1199213|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
1196750|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196751|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196752|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196753|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196754|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196755|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196756|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196757|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196758|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196759|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196760|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196761|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196762|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196763|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196764|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196765|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196766|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196767|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196768|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196769|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196770|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196771|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196772|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196773|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196774|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196775|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196776|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196777|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196778|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196779|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196780|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196781|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196782|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196783|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196784|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196785|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196786|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196787|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196788|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196789|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196790|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196791|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196792|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196793|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196794|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196795|NCT00308581|O1|Outcome|Overall|Overall Induction
1196796|NCT00308581|O1|Outcome|Overall|Overall Induction
1196797|NCT00308581|O1|Outcome|Overall|Overall Induction
1196798|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196799|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196800|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196801|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196802|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196803|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196804|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196805|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196806|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196807|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196808|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196809|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196810|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196811|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196812|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196813|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196814|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196815|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196816|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196817|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196818|NCT00308581|O1|Outcome|Overall|Overall Induction
1196819|NCT00308581|O1|Outcome|Overall|Overall Induction
1196820|NCT00308581|O1|Outcome|Overall|Overall Induction
1196821|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196822|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196823|NCT00308581|O1|Outcome|Overall|Overall Induction
1196824|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196825|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196826|NCT00308581|O1|Outcome|Overall|Overall Induction
1196827|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
1196828|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
1196829|NCT00308581|O1|Outcome|Overall|Overall Induction
1196830|NCT00308581|E3|Reported Event|Induction Phase|Overall population in the Induction phase + safety follow-up period following induction phase.
1196831|NCT00308581|E2|Reported Event|Q2W Regimen|Subjects who were randomized to and received Q2W regimen (every 2 weeks: 400 mg Certolizumab Pegol); randomized maintenance phase + safety follow-up period following randomized maintenance phase.
1196832|NCT00308581|E1|Reported Event|Q4W Regimen|Subjects who were randomized to and received Q4W regimen (every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol); randomized maintenance phase + safety follow-up period following randomized maintenance phase.
1196833|NCT00308555|B3|Baseline|Total|Total of all reporting groups
1196834|NCT00308555|B2|Baseline|Oxycontin|Patients using oxycodone hydrochloride (OxyContin)every 12 hours for chronic pain
1196835|NCT00308555|B1|Baseline|MS Contin|Patients using morphine sulfate (MS Contin) every 12 hours for chronic pain
1196836|NCT00308555|P2|Participant Flow|Oxycontin|Patients using oxycodone hydrochloride (OxyContin) every 12 hours for chronic pain were administered vaporized cannabis (3.96% delta 9-THC) equivalent to one 0.9 g cigarette on the following schedule: 20:00 on Day 1, 08:00/14:00/20:00 on Days 2 through 4, and 08:00 on Day 5.
1196837|NCT00308555|P1|Participant Flow|MS Contin|Patients using morphine sulfate (MS Contin) every 12 hours for chronic pain were administered vaporized cannabis (3.96% delta 9-THC) equivalent to one 0.9 g cigarette on the following schedule: 20:00 on Day 1, 08:00/14:00/20:00 on Days 2 through 4, and 08:00 on Day 5.
1196838|NCT00308555|O2|Outcome|Oxycodone|Participants on oxycodone treatment
1196839|NCT00308555|O1|Outcome|MS Contin|Participants on morphine treatment
1196840|NCT00308555|E2|Reported Event|Oxycontin|Patients using oxycodone hydrochloride (OxyContin)every 12 hours for cancer pain
1196841|NCT00308555|E1|Reported Event|MS Contin|Patients using morphine sulfate (MS Contin) every 12 hours for cancer pain
1196842|NCT00308516|B3|Baseline|Total|Total of all reporting groups
1196843|NCT00308516|B2|Baseline|Postoperative 5FU/Radiation/Bevacizumab|"All patients enrolled in cohort B received 5-fluorouracil (5-FU) 225 mg/m2 IVCI on days 1-42. Bevacizumab was administered at 5 mg/kg IV on day 1 every 2 weeks. These patients also received radiation to 50.4 Gy (1.8 Gy/day or 28 fractions)Monday through Friday during weeks 1-6.~Six weeks after the completion of adjuvant 5-FU/radiation, patients began treatment with 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
1196844|NCT00308516|B1|Baseline|Preoperative 5FU/Radiation/Bevacizumab|"Each patient enrolled in the preoperative cohort received 5-fluorouracil (5-FU) 225 mg/m2 as a continuous infusion (IVCI) on days 1-42 through a portable infusion pump and central venous catheter. Bevacizumab 5 mg/kg was administered intravenously (IV) on days 1 and 15. Additionally these patients received radiation therapy to 50.4 Gy (1.8 Gy/day or 28 fractions) Monday through Friday during weeks 1-6.~At least 8 weeks after surgery, patients in cohort A began 4 months of chemotherapy and bevacizumab. This adjuvant treatment consisted of 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
1196845|NCT00308516|P2|Participant Flow|Postoperative 5FU/Radiation/Bevacizumab|"All patients enrolled in cohort B received 5-fluorouracil (5-FU) 225 mg/m2 IVCI on days 1-42. Bevacizumab was administered at 5 mg/kg IV on day 1 every 2 weeks. These patients also received radiation to 50.4 Gy (1.8 Gy/day or 28 fractions)Monday through Friday during weeks 1-6.~Six weeks after the completion of adjuvant 5-FU/radiation, patients began treatment with 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
1196885|NCT00308230|E2|Reported Event|Congenital Heart Disease|Tetralogy of Fallot, d-transposition of the great arteries, congenitally corrected transposition of the great arteries
1196886|NCT00308230|E1|Reported Event|Control Group|Structurally normal heart without heart disease
1196887|NCT00308139|B3|Baseline|Total|Total of all reporting groups
1196846|NCT00308516|P1|Participant Flow|Preoperative 5FU/Radiation/Bevacizumab|"Each patient enrolled in the preoperative cohort received 5-fluorouracil (5-FU) 225 mg/m2 as a continuous infusion (IVCI) on days 1-42 through a portable infusion pump and central venous catheter. Bevacizumab 5 mg/kg was administered intravenously (IV) on days 1 and 15. Additionally these patients received radiation therapy to 50.4 Gy (1.8 Gy/day or 28 fractions) Monday through Friday during weeks 1-6.~At least 8 weeks after surgery, patients in cohort A began 4 months of chemotherapy and bevacizumab. This adjuvant treatment consisted of 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
1196891|NCT00308139|P1|Participant Flow|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
1196892|NCT00308139|O5|Outcome|Exenatide Once Weekly With Non-SU|Subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -> exenatide once weekly (WK 31-364), and exenatide twice daily -> exenatide once weekly (WK 31-364).
1196847|NCT00308516|O2|Outcome|Postoperative 5FU/Radiation/Bevacizumab|"All patients enrolled in cohort B received 5-fluorouracil (5-FU) 225 mg/m2 IVCI on days 1-42. Bevacizumab was administered at 5 mg/kg IV on day 1 every 2 weeks. These patients also received radiation to 50.4 Gy (1.8 Gy/day or 28 fractions)Monday through Friday during weeks 1-6.~Six weeks after the completion of adjuvant 5-FU/radiation, patients began treatment with 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
1196848|NCT00308516|O1|Outcome|Preoperative 5FU/Radiation/Bevacizumab|"Each patient enrolled in the preoperative cohort received 5-fluorouracil (5-FU) 225 mg/m2 as a continuous infusion (IVCI) on days 1-42 through a portable infusion pump and central venous catheter. Bevacizumab 5 mg/kg was administered intravenously (IV) on days 1 and 15. Additionally these patients received radiation therapy to 50.4 Gy (1.8 Gy/day or 28 fractions) Monday through Friday during weeks 1-6.~At least 8 weeks after surgery, patients in cohort A began 4 months of chemotherapy and bevacizumab. This adjuvant treatment consisted of 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
1196849|NCT00308516|E2|Reported Event|Postoperative 5FU/Radiation/Bevacizumab|"All patients enrolled in cohort B received 5-fluorouracil (5-FU) 225 mg/m2 IVCI on days 1-42. Bevacizumab was administered at 5 mg/kg IV on day 1 every 2 weeks. These patients also received radiation to 50.4 Gy (1.8 Gy/day or 28 fractions)Monday through Friday during weeks 1-6.~Six weeks after the completion of adjuvant 5-FU/radiation, patients began treatment with 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
1196850|NCT00308516|E1|Reported Event|Preoperative 5FU/Radiation/Bevacizumab|"Each patient enrolled in the preoperative cohort received 5-fluorouracil (5-FU) 225 mg/m2 as a continuous infusion (IVCI) on days 1-42 through a portable infusion pump and central venous catheter. Bevacizumab 5 mg/kg was administered intravenously (IV) on days 1 and 15. Additionally these patients received radiation therapy to 50.4 Gy (1.8 Gy/day or 28 fractions) Monday through Friday during weeks 1-6.~At least 8 weeks after surgery, patients in cohort A began 4 months of chemotherapy and bevacizumab. This adjuvant treatment consisted of 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
1196851|NCT00308308|B3|Baseline|Total|Total of all reporting groups
1196852|NCT00308308|B2|Baseline|Insulin Aspart + Insulin Glargine|Comparator
1196853|NCT00308308|B1|Baseline|TI + Insulin Glargine|TI + Insulin glargine
1196854|NCT00308308|P2|Participant Flow|Insulin Aspart + Insulin Glargine|Comparator
1196855|NCT00308308|P1|Participant Flow|TI + Insulin Glargine|TI + Insulin glargine
1196856|NCT00308308|O2|Outcome|Insulin Aspart + Insulin Glargine|Comparator
1196857|NCT00308308|O1|Outcome|TI + Insulin Glargine|TI + Insulin glargine
1196858|NCT00308308|O2|Outcome|Insulin Aspart + Insulin Glargine|Comparator
1196859|NCT00308308|O1|Outcome|TI + Insulin Glargine|TI + Insulin glargine
1196860|NCT00308308|O2|Outcome|Insulin Aspart + Insulin Glargine|Comparator
1196861|NCT00308308|O1|Outcome|TI + Insulin Glargine|TI + Insulin glargine
1196862|NCT00308308|O2|Outcome|Insulin Aspart + Insulin Glargine|Comparator
1196863|NCT00308308|O1|Outcome|TI + Insulin Glargine|TI + Insulin glargine
1196864|NCT00308308|O2|Outcome|Insulin Aspart + Insulin Glargine|Comparator
1196865|NCT00308308|O1|Outcome|TI + Insulin Glargine|TI + Insulin glargine
1196866|NCT00308308|O2|Outcome|Insulin Aspart + Insulin Glargine|Comparator
1196867|NCT00308308|O1|Outcome|TI + Insulin Glargine|TI + Insulin glargine
1196868|NCT00308308|O2|Outcome|Insulin Aspart + Insulin Glargine|Comparator
1196869|NCT00308308|O1|Outcome|TI + Insulin Glargine|TI + Insulin glargine
1196870|NCT00308308|O2|Outcome|Insulin Aspart + Insulin Glargine|Comparator
1196871|NCT00308308|O1|Outcome|TI + Insulin Glargine|TI + Insulin glargine
1196872|NCT00308308|E2|Reported Event|Insulin Aspart + Insulin Glargine|Comparator
1196873|NCT00308308|E1|Reported Event|TI + Insulin Glargine|TI + Insulin glargine
1196874|NCT00308230|B4|Baseline|Total|Total of all reporting groups
1196875|NCT00308230|B3|Baseline|Heart Failure|Acquired left ventricular heart failure, no history of congenital heart disease
1196876|NCT00308230|B2|Baseline|Congenital Heart Disease|Tetralogy of Fallot, d-transposition of the great arteries, congenitally corrected transposition of the great arteries
1196877|NCT00308230|B1|Baseline|Control|Structurally normal heart without heart disease
1196878|NCT00308230|P3|Participant Flow|Heart Failure|Acquired left ventricular heart failure, no history of congenital heart disease
1196879|NCT00308230|P2|Participant Flow|Congenital Heart Disease|Tetralogy of Fallot, d-transposition of the great arteries, congenitally corrected transposition of the great arteries
1196880|NCT00308230|P1|Participant Flow|Control Group|Structurally normal heart without heart disease.
1196881|NCT00308230|O3|Outcome|Heart Failure|Left ventricular failure
1196882|NCT00308230|O2|Outcome|Congenital Heart Disease|TOF, DTGA, CCTGA-tetralogy of Fallot, the transposition of the great arteries, congenitally corrected transposition
1196883|NCT00308230|O1|Outcome|Control Group|Structurally normal hearts
1196884|NCT00308230|E3|Reported Event|Heart Failure|Acquired left ventricular heart failure, no history of congenital heart disease
1196969|NCT00308113|O4|Outcome|Enhanced Standard of Care|Enhanced standard of care.
1196888|NCT00308139|B2|Baseline|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
1196889|NCT00308139|B1|Baseline|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
1196890|NCT00308139|P2|Participant Flow|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
1197019|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
1196893|NCT00308139|O4|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly With Non-SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week not using concomitant SU at screening. Week 31 to week 364.
1196894|NCT00308139|O3|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly With Non-SU|Subjects subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening. Week 31 to week 364
1196895|NCT00308139|O2|Outcome|Exenatide Twice Daily With Non-SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) not using concomitant SU at screening. Week 0 to week 30.
1196896|NCT00308139|O1|Outcome|Exenatide Once Weekly With Non-SU|Subjects subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening. Week 0 to week 30.
1196897|NCT00308139|O5|Outcome|Exenatide Once Weekly With SU|Subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -> exenatide once weekly (WK 31-364), and exenatide twice daily -> exenatide once weekly (WK 31-364).
1196898|NCT00308139|O4|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly With SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364.
1196899|NCT00308139|O3|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly With SU|Subjects subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364
1196900|NCT00308139|O2|Outcome|Exenatide Twice Daily With SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) using concomitant SU at screening. Week 0 to week 30.
1196901|NCT00308139|O1|Outcome|Exenatide Once Weekly With SU|Subjects subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Week 0 to week 30.
1196902|NCT00308139|O3|Outcome|All Treatment|
1196903|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
1196904|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
1196905|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
1196906|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
1196907|NCT00308139|O3|Outcome|All Treatment|
1196908|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
1196909|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
1196910|NCT00308139|O3|Outcome|All Treatment|
1196911|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
1196912|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
1196913|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
1196914|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
1196915|NCT00308139|O3|Outcome|All Treatment|
1196916|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
1196917|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
1196918|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
1196919|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
1196920|NCT00308139|O3|Outcome|All Treatment|
1196921|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once WeeklyEdit|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
1196922|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
1196923|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
1196924|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
1196925|NCT00308139|O3|Outcome|All Treatment|
1196926|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
1196927|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
1196928|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
1196929|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
1196930|NCT00308139|O3|Outcome|All Treatment|
1196931|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
1196932|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
1196933|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 week).
1196934|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
1196935|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
1196936|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
1196937|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
1196938|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
1196939|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
1196940|NCT00308139|O3|Outcome|All Treatmeat|
1196941|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
1196942|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
1196943|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
1196944|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
1196945|NCT00308139|O3|Outcome|All Treatment|
1196946|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
1196947|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
1196948|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
1196949|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
1196950|NCT00308139|O3|Outcome|All Treatment|
1196951|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
1196952|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
1196953|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
1196954|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
1196955|NCT00308139|E5|Reported Event|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -> exenatide once weekly (WK 31-364), and exenatide twice daily -> exenatide once weekly (WK 31-364).
1196956|NCT00308139|E4|Reported Event|Exenatide Twice Daily -> Exenatide Once Weekly (WK 31-364)|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
1196957|NCT00308139|E3|Reported Event|Exenatide Once Weekly -> Exenatide Once Weekly (WK 31-364)|Subcutaneous injection of 2 mg exenatide, once a week.
1196958|NCT00308139|E2|Reported Event|Exenatide Twice Daily (WK 0-30)|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
1196959|NCT00308139|E1|Reported Event|Exenatide Once Weekly (WK 0-30)|Subcutaneous injection of 2 mg exenatide, once a week.
1196960|NCT00308113|B5|Baseline|Total|Total of all reporting groups
1196961|NCT00308113|B4|Baseline|Enhanced Standard of Care|Enhanced standard of care.
1196962|NCT00308113|B3|Baseline|Coenzyme Q10 and Prednisone|"CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.~Prednisone : Prednisone 0/75 mg/kg/day."
1196963|NCT00308113|B2|Baseline|Prednisone Alone|"Prednisone taken once a day each morning by mouth~Prednisone : Prednisone 0/75 mg/kg/day."
1196964|NCT00308113|B1|Baseline|Coenzyme Q10 Alone|"CoenzymeQ10 taken once a day each morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL."
1196965|NCT00308113|P4|Participant Flow|Enhanced Standard of Care|Enhanced standard of care.
1196966|NCT00308113|P3|Participant Flow|Coenzyme Q10 and Prednisone|"CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.~Prednisone : Prednisone 0/75 mg/kg/day."
1196967|NCT00308113|P2|Participant Flow|Prednisone Alone|"Prednisone taken once a day each morning by mouth~Prednisone : Prednisone 0/75 mg/kg/day."
1196968|NCT00308113|P1|Participant Flow|Coenzyme Q10 Alone|"CoenzymeQ10 taken once a day each morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL."
1196970|NCT00308113|O3|Outcome|Coenzyme Q10 and Prednisone|"CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.~Prednisone : Prednisone 0/75 mg/kg/day."
1196971|NCT00308113|O2|Outcome|Prednisone Alone|"Prednisone taken once a day each morning by mouth~Prednisone : Prednisone 0/75 mg/kg/day."
1196972|NCT00308113|O1|Outcome|Coenzyme Q10 Alone|"CoenzymeQ10 taken once a day each morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL."
1196973|NCT00308113|O4|Outcome|Enhanced Standard of Care|Enhanced standard of care.
1196974|NCT00308113|O3|Outcome|Coenzyme Q10 and Prednisone|"CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.~Prednisone : Prednisone 0/75 mg/kg/day."
1196975|NCT00308113|O2|Outcome|Prednisone Alone|"Prednisone taken once a day each morning by mouth~Prednisone : Prednisone 0/75 mg/kg/day."
1197020|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
1196976|NCT00308113|O1|Outcome|Coenzyme Q10 Alone|"CoenzymeQ10 taken once a day each morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL."
1196977|NCT00308113|O4|Outcome|Enhanced Standard of Care|Enhanced standard of care.
1196978|NCT00308113|O3|Outcome|Coenzyme Q10 and Prednisone|"CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.~Prednisone : Prednisone 0/75 mg/kg/day."
1196979|NCT00308113|O2|Outcome|Prednisone Alone|"Prednisone taken once a day each morning by mouth~Prednisone : Prednisone 0/75 mg/kg/day."
1196980|NCT00308113|O1|Outcome|Coenzyme Q10 Alone|"CoenzymeQ10 taken once a day each morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL."
1196981|NCT00308113|E4|Reported Event|Enhanced Standard of Care|Enhanced standard of care.
1196982|NCT00308113|E3|Reported Event|Coenzyme Q10 and Prednisone|"CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.~Prednisone : Prednisone 0/75 mg/kg/day."
1196983|NCT00308113|E2|Reported Event|Prednisone Alone|"Prednisone taken once a day each morning by mouth~Prednisone : Prednisone 0/75 mg/kg/day."
1196984|NCT00308113|E1|Reported Event|Coenzyme Q10 Alone|"CoenzymeQ10 taken once a day each morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL."
1196985|NCT00308087|B3|Baseline|Total|Total of all reporting groups
1196986|NCT00308087|B2|Baseline|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
1196987|NCT00308087|B1|Baseline|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
1196988|NCT00308087|P2|Participant Flow|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
1196989|NCT00308087|P1|Participant Flow|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
1196990|NCT00308087|O2|Outcome|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
1196991|NCT00308087|O1|Outcome|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
1196992|NCT00308087|O2|Outcome|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
1196993|NCT00308087|O1|Outcome|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
1196994|NCT00308087|O2|Outcome|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
1196995|NCT00308087|O1|Outcome|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
1196996|NCT00308087|O2|Outcome|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
1196997|NCT00308087|O1|Outcome|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
1196998|NCT00308087|O2|Outcome|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
1196999|NCT00308087|O1|Outcome|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
1197000|NCT00308087|O2|Outcome|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
1197001|NCT00308087|O1|Outcome|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
1197002|NCT00308087|E2|Reported Event|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
1197003|NCT00308087|E1|Reported Event|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
1197004|NCT00308074|B1|Baseline|Aripiprazole|aripiprazole monotherapy
1197005|NCT00308074|P1|Participant Flow|Aripiprazole|"aripiprazole monotherapy~Aripiprazole will be started at 2.5 or 5mg depending on clinical impression and severity of aggression and agitation. The dose will be evaluated weekly, according to clinical impression and adjusted if deemed appropriate, in not more than 5mg increments . The lowest effective dose will be used."
1197006|NCT00308074|O1|Outcome|Aripiprazole|aripiprazole monotherapy
1197007|NCT00308074|O1|Outcome|Aripiprazole|aripiprazole monotherapy
1197011|NCT00307931|B1|Baseline|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
1197012|NCT00307931|P1|Participant Flow|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
1197013|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
1197014|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
1197015|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
1197016|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
1197017|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
1197018|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
1197021|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
1197022|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
1197023|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
1197024|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
1197025|NCT00307931|E1|Reported Event|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
1197026|NCT00307801|B3|Baseline|Total|Total of all reporting groups
1197027|NCT00307801|B2|Baseline|Placebo|Matching placebo to be taken orally daily.
1197028|NCT00307801|B1|Baseline|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197029|NCT00307801|P2|Participant Flow|Placebo|Matching placebo to be taken orally daily
1197030|NCT00307801|P1|Participant Flow|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197031|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1197032|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197033|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1197034|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197035|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197036|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197037|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197038|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197039|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197040|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197041|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197042|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197043|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197044|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197045|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197046|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197047|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197048|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197049|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197050|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197051|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197465|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197052|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197053|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197054|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197055|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197056|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197057|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197205|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
1197058|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197059|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197060|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197061|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197062|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197063|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197064|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197065|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197066|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197067|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197068|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197069|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197070|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197071|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197072|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197073|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197074|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197075|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197076|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197077|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197078|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197079|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197080|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197081|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197082|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197083|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197084|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197085|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197194|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
1197195|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
1197086|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197087|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197088|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197089|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197090|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197091|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197092|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197093|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197094|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197095|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197096|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197097|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197098|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197099|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197100|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197101|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197102|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197103|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197104|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197105|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197106|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197107|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197108|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197109|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197110|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197111|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197112|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197113|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197114|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197115|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197116|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197117|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197118|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197119|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197196|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
1197197|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
1197120|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197121|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197122|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197123|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197124|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197125|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197126|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197127|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197128|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197129|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197130|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197131|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197132|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197133|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197134|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197135|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
1197136|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197137|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1197138|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197139|NCT00307801|E2|Reported Event|Placebo|Matching placebo to be taken orally daily
1197140|NCT00307801|E1|Reported Event|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
1197141|NCT00307736|B1|Baseline|5-fluorocuracil, Bevacizumab, Erlotinib and Radiation|All patients receive chemoradiation with continuous infusion 5-fluorouracil, bevacizumab and erlotinib.
1197142|NCT00307736|P4|Participant Flow|Phase II (100mg Erlotinib)|"Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.~5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.~bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.~erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.~External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
1197143|NCT00307736|P3|Participant Flow|Phase 1 (150mg Erlotinib)|"Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.~5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.~bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.~erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.~External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
1197144|NCT00307736|P2|Participant Flow|Phase 1 (100mg Erlotinib)|"Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.~5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.~bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.~erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.~External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
1197145|NCT00307736|P1|Participant Flow|Phase 1 (Erlotinib 50mg)|"Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.~5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.~bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.~erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.~External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
1197146|NCT00307736|O3|Outcome|Treated at MTD|"Patients who were treated with erlotinib at maximum tolerated dose, along with standard study therapy.~All patients receive chemoradiation with continuous infusion of 5-fluorouracil, bevacizumab and erlotinib."
1197147|NCT00307736|O2|Outcome|Underwent Resection|"Patients who underwent R0 resection following study therapy~All patients receive chemoradiation with continuous infusion 5-fluorouracil, bevacizumab and erlotinib."
1197148|NCT00307736|O1|Outcome|Completed Study Therapy|"Patients who had pathologic complete response following completion of study therapy.~All patients receive chemo-radiation with continuous infusion 5-fluorouracil, bevacizumab and erlotinib."
1197149|NCT00307736|O1|Outcome|Surgery, 5-fluorocuracil, Bevacizumab, Erlotinib and Radiation|"Patients undergoing R0 resection following chemotherapy and radiation.~Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.~5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.~bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.~erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.~External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
1197206|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
1197207|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
1197208|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
1197209|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
1197150|NCT00307736|O1|Outcome|5-fluorocuracil, Bevacizumab, Erlotinib and Radiation|"Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.~5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.~bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.~erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.~External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
1197151|NCT00307736|O2|Outcome|Grade 4|"Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.~5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.~bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.~erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.~External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
1197152|NCT00307736|O1|Outcome|Grade 3|"Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.~5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.~bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.~erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.~External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
1197153|NCT00307736|O1|Outcome|5-FU, Bevacizumab, Erlotinib and Radiation|All patients received chemoradiation with continuous infusion 5-fluorouracil, bevacizumab and erlotinib. (phase 1 participants)
1197154|NCT00307736|E1|Reported Event|5-fluorocuracil, Bevacizumab, Erlotinib and Radiation|"Continuous infusion 5-fluorouracil 225 mg/M2/d, bevacizumab 5 mg/kg IV q 14 days, erlotinib 50-150 mg orally daily for duration of radiation.~5-fluorouracil: Given as a 24-hour infusion on days 1-14 of each 14-day cycle for a total of 3 cycles.~bevacizumab: Given intravenously on day 1 of each 14-day cycle for a total of 3 cycles.~erlotinib: Taken orally on days 1-14 of each 14-day cycle for a total of 3 cycles.~External beam radiation therapy (EBRT): Given on days 1-5 and 8-12"
1197155|NCT00307684|B1|Baseline|Overall Study Population|Prolonged release (PR) Osmotic Release Oral Systems (OROS) MPH 18 to 90 mg once daily during the OL phase. Subjects who had received at 52 weeks of uninterrupted treatment with PR OROS MPH and provided consent for the DB phase were randomly assigned to placebo or their previous dose of PR OROS MPH (18 to 90 mg once daily)
1197156|NCT00307684|P3|Participant Flow|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
1197157|NCT00307684|P2|Participant Flow|Placebo|matching placebo
1197158|NCT00307684|P1|Participant Flow|Active|PR OROS MPH 18 to 90 mg once daily
1197159|NCT00307684|O3|Outcome|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
1197160|NCT00307684|O2|Outcome|Placebo|matching placebo
1197161|NCT00307684|O1|Outcome|Active|PR OROS MPH 18 to 90 mg once daily
1197162|NCT00307684|O3|Outcome|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
1197163|NCT00307684|O2|Outcome|Placebo|matching placebo
1197164|NCT00307684|O1|Outcome|Active|PR OROS MPH 18 to 90 mg once daily
1197165|NCT00307684|O3|Outcome|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
1197166|NCT00307684|O2|Outcome|Placebo|matching placebo
1197167|NCT00307684|O1|Outcome|Active|PR OROS MPH 18 to 90 mg once daily
1197168|NCT00307684|O3|Outcome|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
1197169|NCT00307684|O2|Outcome|Placebo|matching placebo
1197170|NCT00307684|O1|Outcome|Active|PR OROS MPH 18 to 90 mg once daily
1197171|NCT00307684|O3|Outcome|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
1197172|NCT00307684|O2|Outcome|Placebo|matching placebo
1197173|NCT00307684|O1|Outcome|Active|PR OROS MPH 18 to 90 mg once daily
1197174|NCT00307684|O3|Outcome|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
1197175|NCT00307684|O2|Outcome|Placebo|matching placebo
1197176|NCT00307684|O1|Outcome|Active|PR OROS MPH 18 to 90 mg once daily
1197177|NCT00307684|O3|Outcome|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
1197178|NCT00307684|O2|Outcome|Placebo|matching placebo
1197179|NCT00307684|O1|Outcome|Active|PR OROS MPH 18 to 90 mg once daily
1197180|NCT00307684|E3|Reported Event|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
1197181|NCT00307684|E2|Reported Event|Placebo|matching placebo
1197182|NCT00307684|E1|Reported Event|Active|PR OROS MPH 18 to 90 mg once daily
1197183|NCT00307489|B3|Baseline|Total|Total of all reporting groups
1197184|NCT00307489|B2|Baseline|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
1197185|NCT00307489|B1|Baseline|Tenofovir DF|tenofovir DF 300 mg QD
1197186|NCT00307489|P2|Participant Flow|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
1197187|NCT00307489|P1|Participant Flow|Tenofovir DF|tenofovir DF 300 mg QD
1197188|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
1197189|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
1197190|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
1197191|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
1197192|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
1197193|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
1197461|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197198|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
1197199|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
1197200|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
1197201|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
1197202|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
1197203|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
1197204|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
1197210|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
1197211|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
1197212|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
1197213|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
1197214|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
1197215|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
1197216|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
1197217|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
1197218|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
1197219|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
1197220|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
1197221|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
1197222|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
1197223|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
1197224|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
1197225|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
1197226|NCT00307489|E2|Reported Event|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
1197227|NCT00307489|E1|Reported Event|Tenofovir DF|tenofovir DF 300 mg QD
1197228|NCT00307437|B4|Baseline|Total|Total of all reporting groups
1197229|NCT00307437|B3|Baseline|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, participants who achieved a greater than and equal 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 90 mg every 12 week or dose adjust to 90 mg every 8 week dosing.
1197230|NCT00307437|B2|Baseline|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, participants who achieved a greater than and equal to 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 45 mg every 12 week or dose adjust to 45 mg every 8 week dosing.
1197231|NCT00307437|B1|Baseline|Group I: Placebo|Placebo participants received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
1197232|NCT00307437|P7|Participant Flow|Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) – patients receiving ustekinumab 90 mg at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 16 to Week 244.
1197233|NCT00307437|P6|Participant Flow|Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) – patients receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving ustekinumab 45 mg q12wk or q8wk from Week 16 to Week 244. Some patients in this group dose escalated from ustekinumab 45 mg to 90 mg after Week 52.
1197234|NCT00307437|P5|Participant Flow|Placebo -> Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 12 to Week 244.
1197235|NCT00307437|P4|Participant Flow|Placebo -> Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg q12wk or q8wk from Week 12 to Week 244. Some patients in this group dose escalated from ustekinumab 45 mg to 90 mg after Week 52.
1197236|NCT00307437|P3|Participant Flow|Ustekinumab 90 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 90 mg group
1197237|NCT00307437|P2|Participant Flow|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg group
1197238|NCT00307437|P1|Participant Flow|Placebo (CP)|Controlled period (Week 0-12) - Placebo group
1197239|NCT00307437|O6|Outcome|Group 6: Combined (12 Week Dosing)|Combined Groups 2 and 4 (dosing every 12 weeks)
1197240|NCT00307437|O5|Outcome|Group 5: Combined (8 Week Dosing)|Combined Groups 1 and 3 (dosing every 8 weeks)
1197241|NCT00307437|O4|Outcome|Group 4: Ustekinumab 90 mg Every 12 Weeks|Participants received ustekinumab 90 mg at Weeks 0, 4, 16, 28 and 40.
1197242|NCT00307437|O3|Outcome|Group 3: Ustekinumab 90 mg Every 8 Weeks|Participants received ustekinumab 90 mg at Weeks 0, 4, 16., 28, 36 and 44.
1197243|NCT00307437|O2|Outcome|Group 2: Ustekinumab 45mg Every 12 Weeks|Participants received ustekinumab 45 mg at Weeks 0, 4, 16, 28 and 40.
1197244|NCT00307437|O1|Outcome|Group 1: Ustekinumab 45mg Every 8 Weeks|Participants received ustekinumab 45 mg at Weeks 0, 4, 16, 28, 36 and 44.
1197245|NCT00307437|O3|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, participants who achieved a greater than and equal 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 90 mg every 12 week or dose adjust to 90 mg every 8 week dosing.
1199117|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
1197246|NCT00307437|O2|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, participants who achieved a greater than and equal 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 45 mg every 12 week or dose adjust to 45 mg every 8 week dosing.
1197247|NCT00307437|O1|Outcome|Group I: Placebo|Placebo participants received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
1197248|NCT00307437|O3|Outcome|Group III: Ustekinumab 90 mg|Partcipants received ustekinumab 90 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, partcipants who achieved a greater than and equal to 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 90 mg every 12 week or dose adjust to 90 mg every 8 week dosing.
1197284|NCT00307164|P1|Participant Flow|NucleomaxX|Participants received NucleomaxX for uridine through week 48
1197285|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
1197249|NCT00307437|O2|Outcome|Group II: Ustekinumab 45 mg|Partcipants received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, partcipants who achieved a greater than and equal 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 45 mg every 12 week or dose adjust to 45 mg every 8 week dosing.
1197250|NCT00307437|O1|Outcome|Group I: Placebo|Placebo partcipants received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
1197251|NCT00307437|O3|Outcome|Group III: Ustekinumab 90 mg|Partcipants received ustekinumab 90 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, partcipants who achieved a greater than and equal 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 90 mg every 12 week or dose adjust to 90 mg every 8 week dosing.
1197252|NCT00307437|O2|Outcome|Group II: Ustekinumab 45 mg|Partcipants received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, partcipants who achieved a greater than and equal 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 45 mg every 12 week or dose adjust to 45 mg every 8 week dosing.
1197253|NCT00307437|O1|Outcome|Group I: Placebo|Placebo participants received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
1197254|NCT00307437|E7|Reported Event|Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) – patients receiving ustekinumab 90 mg at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 16 to Week 244.
1197255|NCT00307437|E6|Reported Event|Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) – patients receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving ustekinumab 45 mg q12wk or q8wk from Week 16 to Week 244. Some patients in this group dose escalated from ustekinumab 45 mg to 90 mg after Week 52.
1197256|NCT00307437|E5|Reported Event|Placebo -> Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 12 to Week 244.
1197257|NCT00307437|E4|Reported Event|Placebo -> Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg q12wk or q8wk from Week 12 to Week 244. Some patients in this group dose escalated from ustekinumab 45 mg to 90 mg after Week 52.
1197258|NCT00307437|E3|Reported Event|Ustekinumab 90 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 90 mg group
1197259|NCT00307437|E2|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg group
1197260|NCT00307437|E1|Reported Event|Placebo (CP)|Controlled period (Week 0-12) - Placebo group
1197261|NCT00307333|B3|Baseline|Total|Total of all reporting groups
1197262|NCT00307333|B2|Baseline|Control|Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
1197263|NCT00307333|B1|Baseline|Intervention|Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
1197264|NCT00307333|P2|Participant Flow|Control|Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
1197265|NCT00307333|P1|Participant Flow|Intervention|Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
1197266|NCT00307333|O2|Outcome|Control|Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
1197267|NCT00307333|O1|Outcome|Intervention|Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
1197268|NCT00307333|O2|Outcome|Control|Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
1197269|NCT00307333|O1|Outcome|Intervention|Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
1197270|NCT00307333|O2|Outcome|Control|Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
1197271|NCT00307333|O1|Outcome|Intervention|Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
1197272|NCT00307333|O2|Outcome|Control|Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
1197273|NCT00307333|O1|Outcome|Intervention|Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
1197274|NCT00307333|E2|Reported Event|Control|Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
1197275|NCT00307333|E1|Reported Event|Intervention|Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
1197276|NCT00307294|B1|Baseline|Thalidomide and Doxil|"Combination of Thalidomide and Doxil~Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg~Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days"
1197277|NCT00307294|P1|Participant Flow|Thalidomide and Doxil|"Combination of Thalidomide and Doxil~Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg~Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days"
1197278|NCT00307294|O1|Outcome|Thalidomide and Doxil|"Combination of Thalidomide and Doxil~Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg~Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days"
1197279|NCT00307294|E1|Reported Event|Thalidomide and Doxil|"Combination of Thalidomide and Doxil~Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg~Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days"
1197280|NCT00307164|B3|Baseline|Total|Total of all reporting groups
1197281|NCT00307164|B2|Baseline|Placebo|Participants received NucleomaxX placebo through week 48
1197282|NCT00307164|B1|Baseline|NucleomaxX|Participants received NucleomaxX for uridine through week 48
1197283|NCT00307164|P2|Participant Flow|Placebo|Participants received NucleomaxX placebo through week 48
1197578|NCT00306917|B3|Baseline|Total|Total of all reporting groups
1197286|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
1197287|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
1197288|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
1197289|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
1197290|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
1197291|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
1197292|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
1197293|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
1197294|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
1197295|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
1197296|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
1197297|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
1197298|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
1197299|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
1197300|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
1197301|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
1197302|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
1197303|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
1197304|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
1197305|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
1197306|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
1197307|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
1197308|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
1197309|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
1197310|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
1197311|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
1197312|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
1197313|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
1197314|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
1197315|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
1197316|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
1197317|NCT00307164|E2|Reported Event|Placebo|Participants received NucleomaxX placebo through week 48
1197318|NCT00307164|E1|Reported Event|NucleomaxX|Participants received NucleomaxX for uridine through week 48
1197319|NCT00307151|B5|Baseline|Total|Total of all reporting groups
1197320|NCT00307151|B4|Baseline|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
1197321|NCT00307151|B3|Baseline|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
1197322|NCT00307151|B2|Baseline|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
1197323|NCT00307151|B1|Baseline|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
1197324|NCT00307151|P4|Participant Flow|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
1197325|NCT00307151|P3|Participant Flow|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
1197326|NCT00307151|P2|Participant Flow|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
1197327|NCT00307151|P1|Participant Flow|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
1197328|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
1197329|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
1197330|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
1197331|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
1197332|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
1197333|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
1197334|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
1197335|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
1197336|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
1197337|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
1197338|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
1197339|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
1197340|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
1197341|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
1197342|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
1197343|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
1197344|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
1197345|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
1197346|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
1197347|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
1197348|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
1197349|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
1197350|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
1197351|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
1197352|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
1197353|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
1197354|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
1197355|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
1197356|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
1197357|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
1197358|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
1197359|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
1197360|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
1197361|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
1197362|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
1197363|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
1197364|NCT00307151|E4|Reported Event|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen.
1197365|NCT00307151|E3|Reported Event|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen.
1197366|NCT00307151|E2|Reported Event|Coh I: LPV/r|Cohort II: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
1197367|NCT00307151|E1|Reported Event|Coh I: NVP|Cohort II: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
1197368|NCT00307125|B3|Baseline|Total|Total of all reporting groups
1197369|NCT00307125|B2|Baseline|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
1197370|NCT00307125|B1|Baseline|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
1197371|NCT00307125|P3|Participant Flow|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
1197372|NCT00307125|P2|Participant Flow|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
1197373|NCT00307125|P1|Participant Flow|Screening Phase|Kidney (renal) transplant recipients with no detectable anti-human leukocyte antigen (HLA) antibodies prior to transplant. Participants were screened for the development of anti-HLA antibodies once every 3 months up to 36 months post-transplantation and yearly thereafter until Month 60.
1197374|NCT00307125|O2|Outcome|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
1197462|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197375|NCT00307125|O1|Outcome|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
1197376|NCT00307125|O2|Outcome|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
1197377|NCT00307125|O1|Outcome|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
1197378|NCT00307125|O2|Outcome|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
1197379|NCT00307125|O1|Outcome|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
1197380|NCT00307125|O2|Outcome|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
1197381|NCT00307125|O1|Outcome|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
1197382|NCT00307125|O2|Outcome|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
1197383|NCT00307125|O1|Outcome|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
1197384|NCT00307125|O2|Outcome|Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject ≤18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression is site-specific."
1197385|NCT00307125|O1|Outcome|Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects ≤18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
1197386|NCT00307125|O2|Outcome|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
1197387|NCT00307125|O1|Outcome|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
1197388|NCT00307125|O2|Outcome|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
1197389|NCT00307125|O1|Outcome|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
1197390|NCT00307125|O1|Outcome|Screening Phase|Participants who were analyzed during the screening phase of the study
1197391|NCT00307125|O1|Outcome|Screening Phase|Participants who were analyzed during the screening phase/stage of the study
1197392|NCT00307125|E2|Reported Event|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
1197393|NCT00307125|E1|Reported Event|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
1197394|NCT00307086|B1|Baseline|Autologous PBSCT|"bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous peripheral blood stem cell transplant~Bortezomib : the maximum tolerated dose (MTD) of bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous stem cell transplant~PBSCT : PBSCT #1 Day 0 PBSCT #2 Day 0 (approx 90 days =/- 15 days after PBSCT #1)~Melphalan : Day -4 melphalan 100 mg/m2 intravenously over 30 minutes, Day -3 melphalan 100 mg/m2 intravenously over 30 minutes"
1197395|NCT00307086|P1|Participant Flow|Autologous PBSCT|"bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous peripheral blood stem cell transplant~Bortezomib : the maximum tolerated dose (MTD) of bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous stem cell transplant~PBSCT : PBSCT #1 Day 0 PBSCT #2 Day 0 (approx 90 days =/- 15 days after PBSCT #1)~Melphalan : Day -4 melphalan 100 mg/m2 intravenously over 30 minutes, Day -3 melphalan 100 mg/m2 intravenously over 30 minutes"
1197396|NCT00307086|O1|Outcome|Autologous PBSCT|"bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous peripheral blood stem cell transplant~Bortezomib : the maximum tolerated dose (MTD) of bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous stem cell transplant~PBSCT : PBSCT #1 Day 0 PBSCT #2 Day 0 (approx 90 days =/- 15 days after PBSCT #1)~Melphalan : Day -4 melphalan 100 mg/m2 intravenously over 30 minutes, Day -3 melphalan 100 mg/m2 intravenously over 30 minutes"
1197463|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197464|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1199118|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
1197397|NCT00307086|E1|Reported Event|Autologous PBSCT|"bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous peripheral blood stem cell transplant~Bortezomib : the maximum tolerated dose (MTD) of bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous stem cell transplant~PBSCT : PBSCT #1 Day 0 PBSCT #2 Day 0 (approx 90 days =/- 15 days after PBSCT #1)~Melphalan : Day -4 melphalan 100 mg/m2 intravenously over 30 minutes, Day -3 melphalan 100 mg/m2 intravenously over 30 minutes"
1197398|NCT00307047|B3|Baseline|Total|Total of all reporting groups
1197399|NCT00307047|B2|Baseline|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197400|NCT00307047|B1|Baseline|XIENCE V®|Patients recieving the XIENCE V® stent
1197401|NCT00307047|P2|Participant Flow|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197402|NCT00307047|P1|Participant Flow|XIENCE V®|Patients recieving the XIENCE V® stent
1197403|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197404|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197405|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197406|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197407|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197408|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197409|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197410|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197411|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197412|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197413|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197414|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197415|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197416|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197417|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197418|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197419|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197420|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197421|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197422|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197423|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197424|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197425|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197426|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197427|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197428|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197429|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197430|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197431|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197432|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197433|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197434|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197435|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197436|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197437|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197438|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197439|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197440|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197441|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197442|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197443|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197444|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197445|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197446|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197447|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197448|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197449|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197450|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197451|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197452|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197453|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197454|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197455|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197456|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197457|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197458|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197459|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197460|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197466|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197467|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197468|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197469|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197470|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197471|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197472|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197473|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197474|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197475|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197476|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197477|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197478|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197479|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197480|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197481|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197482|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197483|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197484|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197485|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197486|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197487|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197488|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197489|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197490|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197491|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197492|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197493|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197494|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197495|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197496|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197497|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197498|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197499|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197500|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197501|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197502|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197503|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197504|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197505|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197506|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197507|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197508|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197509|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197510|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197511|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197512|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197513|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197514|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197515|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197516|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197517|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197518|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197519|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197520|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197521|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197522|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197523|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197524|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197525|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197526|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197527|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197528|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197529|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197530|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197531|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197532|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197533|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197534|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
1197535|NCT00307047|E2|Reported Event|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
1197536|NCT00307047|E1|Reported Event|XIENCE V®|Patients recieving the XIENCE V® stent
1197537|NCT00307034|B3|Baseline|Total|Total of all reporting groups
1197538|NCT00307034|B2|Baseline|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197539|NCT00307034|B1|Baseline|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197540|NCT00307034|P2|Participant Flow|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197541|NCT00307034|P1|Participant Flow|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197542|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197543|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197544|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197545|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197546|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197601|NCT00306891|O1|Outcome|Arm 1 - Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
1197602|NCT00306891|O2|Outcome|Arm 2 - Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
1197603|NCT00306891|O1|Outcome|Arm 1 - Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
1197604|NCT00306891|O2|Outcome|Arm 2 - Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
1197605|NCT00306891|O1|Outcome|Arm 1 - Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
1197547|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197617|NCT00306852|B1|Baseline|Trabeculectomy|"Trabeculectomy with mitomycin C~Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
1197760|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
1197548|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197549|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197550|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197551|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197552|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197553|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197554|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197555|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197556|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197606|NCT00306891|O2|Outcome|Arm 2 - Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
1197607|NCT00306891|O1|Outcome|Arm 1 - Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
1199119|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
1197557|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197558|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197559|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197560|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197561|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197562|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197563|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197564|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197565|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197566|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197608|NCT00306891|O2|Outcome|Arm 2 - Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
1197609|NCT00306891|O1|Outcome|Arm 1 - Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
1197610|NCT00306891|O2|Outcome|Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
1197567|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197568|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197569|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197570|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197571|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197572|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197573|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197574|NCT00307034|O2|Outcome|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197575|NCT00307034|O1|Outcome|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197576|NCT00307034|E2|Reported Event|Synflorix II Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2, 3 and 4 months of age, co-administered with 2 doses of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib) at 2 and 4 months of age, followed by a booster dose of the Synflorix™ vaccine at 11 months of age, co-administered with one dose of the Infanrix™ combined vaccine, according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197611|NCT00306891|O1|Outcome|Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
1197612|NCT00306891|E3|Reported Event|Cediranib 30 - 90 mg Dose Escalation|Cediranib 30 - 90 mg Dose Escalation
1199120|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
1197577|NCT00307034|E1|Reported Event|Synflorix I Group|Healthy male or female subjects between and including 8 to 16 weeks (56-120 days) of age at the time of first vaccination, received a 2-dose primary vaccination course of Synflorix™ (10Pn-PD-DiT) vaccine at 2 and 4 months of age, followed by a booster dose of the same vaccine at 11 months of age, each dose being co-administered with one dose of Infanrix Hexa™ (DTPa-HBV-IPV/Hib) or Infanrix™-IPV/Hib (DTPa-IPV/Hib), according to national recommendations. Synflorix™ vaccine was administered intramuscularly into the right antero-lateral thigh and Infanrix™ combined vaccine was administered intramuscularly into the left antero-lateral thigh.
1197579|NCT00306917|B2|Baseline|Porocoat Porous Coated|The Summit™ Porocoat® stems are primary, cementless hip implants that a feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The lower portion of the stems has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
1197580|NCT00306917|B1|Baseline|DuoFix HA|The Summit™ DuoFix™ HA stems are primary, cementless hip implants. Summit™ cementless stems feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The DuoFix™ HA stem also has a thin coating of hydroxyapatite on this porous-coated surface. This HA coating is only 35 microns thick, so the optimum pore size is maintained. The lower portion of the stem has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
1197581|NCT00306917|P2|Participant Flow|Porocoat Porous Coated|The Summit™ Porocoat® stems are primary, cementless hip implants that a feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The lower portion of the stems has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
1197582|NCT00306917|P1|Participant Flow|DuoFix HA|The Summit™ DuoFix™ HA stems are primary, cementless hip implants. Summit™ cementless stems feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The DuoFix™ HA stem also has a thin coating of hydroxyapatite on this porous-coated surface. This HA coating is only 35 microns thick, so the optimum pore size is maintained. The lower portion of the stem has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
1197583|NCT00306917|O2|Outcome|Porocoat Porous Coated|The Summit™ Porocoat® stems are primary, cementless hip implants that a feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The lower portion of the stems has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
1197584|NCT00306917|O1|Outcome|DuoFix HA|The Summit™ DuoFix™ HA stems are primary, cementless hip implants. Summit™ cementless stems feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The DuoFix™ HA stem also has a thin coating of hydroxyapatite on this porous-coated surface. This HA coating is only 35 microns thick, so the optimum pore size is maintained. The lower portion of the stem has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
1197585|NCT00306917|E2|Reported Event|Porocoat Porous Coated|The Summit™ Porocoat® stems are primary, cementless hip implants that a feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The lower portion of the stems has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
1197586|NCT00306917|E1|Reported Event|DuoFix HA|The Summit™ DuoFix™ HA stems are primary, cementless hip implants. Summit™ cementless stems feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The DuoFix™ HA stem also has a thin coating of hydroxyapatite on this porous-coated surface. This HA coating is only 35 microns thick, so the optimum pore size is maintained. The lower portion of the stem has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
1197587|NCT00306891|B5|Baseline|Total|Total of all reporting groups
1197588|NCT00306891|B4|Baseline|Cediranib 30 to 90 mg Dose Escalation|Part B: Cediranib Dose Escalation
1197589|NCT00306891|B3|Baseline|Cediranib 45 mg Fixed Dose|Part B: Cediranib 45 mg Fixed Dose
1197590|NCT00306891|B2|Baseline|Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
1197591|NCT00306891|B1|Baseline|Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
1197592|NCT00306891|P4|Participant Flow|Cediranib 30 to 90 mg Dose Escalation|Part B: Cediranib Dose Escalation
1197593|NCT00306891|P3|Participant Flow|Cediranib 45 mg Fixed Dose|Part B: Cediranib 45 mg Fixed Dose
1197594|NCT00306891|P2|Participant Flow|Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
1197595|NCT00306891|P1|Participant Flow|Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
1197596|NCT00306891|O2|Outcome|Arm 4 - Cediranib 30-90 mg Dose Escalation|Part B: Cediranib 30-90 mg Dose Escalation
1197597|NCT00306891|O1|Outcome|Arm 3 - Cediranib 45 mg Fixed Dose|Part B: Cediranib 45 mg Fixed Dose
1197598|NCT00306891|O2|Outcome|Arm 4 - Cediranib 30-90 mg Dose Escalation|Part B: Cediranib 30-90 mg Dose Escalation
1197599|NCT00306891|O1|Outcome|Arm 3 - Cediranib 45 mg Fixed Dose|Part B: Cediranib 45 mg Fixed Dose
1197600|NCT00306891|O2|Outcome|Arm 2 - Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
1197613|NCT00306891|E2|Reported Event|Cediranib 45 mg Fixed Dose|Part B: Cediranib 45 mg Fixed Dose
1197614|NCT00306891|E1|Reported Event|Cediranib 45 mg Part A|Part A: Cediranib 45 mg
1197615|NCT00306852|B3|Baseline|Total|Total of all reporting groups
1197616|NCT00306852|B2|Baseline|Implant|"Baerveldt Implant~Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
1197759|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
1197618|NCT00306852|P2|Participant Flow|Implant|"Baerveldt Implant~Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
1197619|NCT00306852|P1|Participant Flow|Trabeculectomy|"Trabeculectomy with mitomycin C~Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
1197620|NCT00306852|O2|Outcome|Implant|"Baerveldt Implant~Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
1197621|NCT00306852|O1|Outcome|Trabeculectomy|"Trabeculectomy with mitomycin C~Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
1197622|NCT00306852|O2|Outcome|Implant|"Baerveldt Implant~Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
1197623|NCT00306852|O1|Outcome|Trabeculectomy|"Trabeculectomy with mitomycin C~Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
1197624|NCT00306852|O2|Outcome|Implant|"Baerveldt Implant~Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
1197625|NCT00306852|O1|Outcome|Trabeculectomy|"Trabeculectomy with mitomycin C~Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
1197626|NCT00306852|O2|Outcome|Implant|"Baerveldt Implant~Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
1197627|NCT00306852|O1|Outcome|Trabeculectomy|"Trabeculectomy with mitomycin C~Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
1197628|NCT00306852|O2|Outcome|Implant|"Baerveldt Implant~Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
1197629|NCT00306852|O1|Outcome|Trabeculectomy|"Trabeculectomy with mitomycin C~Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
1197630|NCT00306852|O2|Outcome|Implant|"Baerveldt Implant~Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
1197631|NCT00306852|O1|Outcome|Trabeculectomy|"Trabeculectomy with mitomycin C~Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
1197632|NCT00306852|E2|Reported Event|Implant|"Baerveldt Implant~Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
1197633|NCT00306852|E1|Reported Event|Trabeculectomy|"Trabeculectomy with mitomycin C~Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
1197634|NCT00306787|B3|Baseline|Total|Total of all reporting groups
1197635|NCT00306787|B2|Baseline|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
1197636|NCT00306787|B1|Baseline|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
1197637|NCT00306787|P2|Participant Flow|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
1197638|NCT00306787|P1|Participant Flow|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
1197639|NCT00306787|O2|Outcome|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
1198108|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1197640|NCT00306787|O1|Outcome|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
1197641|NCT00306787|O2|Outcome|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
1199214|NCT00301262|O1|Outcome|DB Viagra Week 8|
1197642|NCT00306787|O1|Outcome|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
1197643|NCT00306787|O2|Outcome|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
1197644|NCT00306787|O1|Outcome|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
1197645|NCT00306787|O2|Outcome|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
1197646|NCT00306787|O1|Outcome|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
1197647|NCT00306787|O2|Outcome|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
1197648|NCT00306787|O1|Outcome|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
1197649|NCT00306787|O2|Outcome|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
1197650|NCT00306787|O1|Outcome|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
1197651|NCT00306787|E2|Reported Event|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
1197652|NCT00306787|E1|Reported Event|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
1197653|NCT00306670|B3|Baseline|Total|Total of all reporting groups
1197654|NCT00306670|B2|Baseline|Oral Cyclophosphamide|"Patients will receive oral cyclophosphamide.~prednisone: <30 mg/day"
1197655|NCT00306670|B1|Baseline|Rituximab|"Patients will receive rituximab.~Rituxan: Acquired Hemophilia A Patients Who Have Developed Anti-Factor VIII Antibodies~prednisone: <30 mg/day"
1197656|NCT00306670|P2|Participant Flow|Oral Cyclophosphamide|"Patients will receive oral cyclophosphamide.~prednisone: <30 mg/day"
1197657|NCT00306670|P1|Participant Flow|Rituximab|"Patients will receive rituximab.~Rituxan: Acquired Hemophilia A Patients Who Have Developed Anti-Factor VIII Antibodies~prednisone: <30 mg/day"
1197658|NCT00306670|O2|Outcome|Oral Cyclophosphamide|"Patients will receive oral cyclophosphamide.~prednisone: <30 mg/day"
1197659|NCT00306670|O1|Outcome|Rituximab|"Patients will receive rituximab.~Rituxan: Acquired Hemophilia A Patients Who Have Developed Anti-Factor VIII Antibodies~prednisone: <30 mg/day"
1197660|NCT00306670|E2|Reported Event|Oral Cyclophosphamide|"Patients will receive oral cyclophosphamide.~prednisone: <30 mg/day"
1197661|NCT00306670|E1|Reported Event|Rituximab|"Patients will receive rituximab.~Rituxan: Acquired Hemophilia A Patients Who Have Developed Anti-Factor VIII Antibodies~prednisone: <30 mg/day"
1197662|NCT00306592|B1|Baseline|300 mg Natalizumab IV Monthly|All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
1197754|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
1197663|NCT00306592|P2|Participant Flow|Natalizumab Study 101-MS-321 (NCT00297232)|Open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 268 weeks. (Week 52 through Week 480 of Study 101-MS-321 (NCT00297232) is considered to be the Long-Term Treatment Period).
1197664|NCT00306592|P1|Participant Flow|Natalizumab Study 101-MS-322 (NCT00306592)|Open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
1199215|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
1197665|NCT00306592|O1|Outcome|300 mg Natalizumab IV Monthly|All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
1197666|NCT00306592|O1|Outcome|300 mg Natalizumab IV Monthly|All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
1197667|NCT00306592|O1|Outcome|300 mg Natalizumab IV Monthly|All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
1197668|NCT00306592|E1|Reported Event|300 mg Natalizumab IV Monthly|All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
1197669|NCT00306527|B5|Baseline|Total|Total of all reporting groups
1197670|NCT00306527|B4|Baseline|Elderly (cTIV\TIV) + (TIV\TIV)|Subjects (≥61 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.
1197671|NCT00306527|B3|Baseline|Adults (cTIV\TIV) + (TIV\TIV)|Subjects (18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.
1197672|NCT00306527|B2|Baseline|Elderly (cTIV\cTIV) + (TIV\cTIV)|Subjects(≥61 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine, received one dose of cTIV in this study, one year later.
1197673|NCT00306527|B1|Baseline|Adults (cTIV\cTIV) + (TIV\cTIV)|Subjects(18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine, received one dose of cTIV in this study, one year later.
1197674|NCT00306527|P4|Participant Flow|Elderly (cTIV\TIV) + (TIV\TIV)|Subjects (≥61years) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.
1197675|NCT00306527|P3|Participant Flow|Elderly (cTIV\cTIV) + (TIV\cTIV)|Subjects(≥61years of age ) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of cTIV in this study, one year later.
1197676|NCT00306527|P2|Participant Flow|Adults (cTIV\TIV) + (TIV\TIV)|Subjects (18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.
1197677|NCT00306527|P1|Participant Flow|Adults (cTIV\cTIV) + (TIV\cTIV)|Subjects (18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of cTIV in this study, one year later.
1197678|NCT00306527|O8|Outcome|TIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
1197679|NCT00306527|O7|Outcome|TIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
1197680|NCT00306527|O6|Outcome|TIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
1197681|NCT00306527|O5|Outcome|TIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
1197682|NCT00306527|O4|Outcome|cTIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
1197683|NCT00306527|O3|Outcome|cTIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
1197684|NCT00306527|O2|Outcome|cTIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
1197685|NCT00306527|O1|Outcome|cTIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
1197686|NCT00306527|O8|Outcome|TIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
1197687|NCT00306527|O7|Outcome|TIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
1197688|NCT00306527|O6|Outcome|TIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
1197689|NCT00306527|O5|Outcome|TIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
1197690|NCT00306527|O4|Outcome|cTIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
1197691|NCT00306527|O3|Outcome|cTIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
1197692|NCT00306527|O2|Outcome|cTIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
1197693|NCT00306527|O1|Outcome|cTIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
1197694|NCT00306527|O8|Outcome|TIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
1197695|NCT00306527|O7|Outcome|TIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
1197696|NCT00306527|O6|Outcome|TIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
1197697|NCT00306527|O5|Outcome|TIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
1197698|NCT00306527|O4|Outcome|cTIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
1197699|NCT00306527|O3|Outcome|cTIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
1197700|NCT00306527|O2|Outcome|cTIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
1197701|NCT00306527|O1|Outcome|cTIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
1197702|NCT00306527|O8|Outcome|TIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
1197703|NCT00306527|O7|Outcome|TIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
1197704|NCT00306527|O6|Outcome|TIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
1197705|NCT00306527|O5|Outcome|TIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
1197706|NCT00306527|O4|Outcome|cTIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
1197707|NCT00306527|O3|Outcome|cTIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
1197708|NCT00306527|O2|Outcome|cTIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
1197709|NCT00306527|O1|Outcome|cTIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
1197710|NCT00306527|O8|Outcome|TIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
1197711|NCT00306527|O7|Outcome|TIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
1197712|NCT00306527|O6|Outcome|TIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
1197713|NCT00306527|O5|Outcome|TIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
1197714|NCT00306527|O4|Outcome|cTIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
1197715|NCT00306527|O3|Outcome|cTIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
1197716|NCT00306527|O2|Outcome|cTIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
1197755|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
1197717|NCT00306527|O1|Outcome|cTIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
1197718|NCT00306527|O8|Outcome|TIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
1197719|NCT00306527|O7|Outcome|TIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
1197720|NCT00306527|O6|Outcome|TIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
1197721|NCT00306527|O5|Outcome|TIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
1197722|NCT00306527|O4|Outcome|cTIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
1197723|NCT00306527|O3|Outcome|cTIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
1197724|NCT00306527|O2|Outcome|cTIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
1197725|NCT00306527|O1|Outcome|cTIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
1197726|NCT00306527|E4|Reported Event|Elderly (cTIV\TIV) + (TIV\TIV)|Subjects (≥61 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.
1197727|NCT00306527|E3|Reported Event|Elderly (cTIV\cTIV) + (TIV\cTIV)|Subjects(≥61 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of cTIV in this study, one year later.
1197728|NCT00306527|E2|Reported Event|Adults (cTIV/TIV) + (TIV\TIV)|Subjects (18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.
1197729|NCT00306527|E1|Reported Event|Adults (cTIV\cTIV) + (TIV\cTIV)|Subjects(18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of cTIV in this study, one year later.
1197730|NCT00306488|B1|Baseline|Participant Information|
1197731|NCT00306488|P2|Participant Flow|Fellow Eye|The fellow eye was not treated with the study medication (OT-511 antioxidant eye drops).
1197732|NCT00306488|P1|Participant Flow|Study Eye: OT-511 Antioxidant Eye Drop|The study eye was treated with one drop (40µL) of 0.45% OT-551 antioxidant eye drops three times a day.
1197733|NCT00306488|O2|Outcome|Fellow Eye|The fellow eye was not treated with the study medication (OT-511 antioxidant eye drops).
1197734|NCT00306488|O1|Outcome|Study Eye: OT-511 Antioxidant Eye Drop|The study eye was treated with one drop (40µL) of 0.45% OT-551 antioxidant eye drops three times a day.
1197735|NCT00306488|O2|Outcome|Fellow Eye|The fellow eye was not treated with the study medication (OT-511 antioxidant eye drops).
1197736|NCT00306488|O1|Outcome|Study Eye: OT-511 Antioxidant Eye Drop|The study eye was treated with one drop (40µL) of 0.45% OT-551 antioxidant eye drops three times a day.
1197737|NCT00306488|O2|Outcome|Fellow Eye|The fellow eye was not treated with the study medication (OT-511 antioxidant eye drops).
1197738|NCT00306488|O1|Outcome|Study Eye: OT-511 Antioxidant Eye Drop|The study eye was treated with one drop (40µL) of 0.45% OT-551 antioxidant eye drops three times a day.
1197739|NCT00306488|O2|Outcome|Fellow Eye|The fellow eye was not treated with the study medication (OT-511 antioxidant eye drops).
1197740|NCT00306488|O1|Outcome|Study Eye: OT-511 Antioxidant Eye Drop|The study eye was treated with one drop (40µL) of 0.45% OT-551 antioxidant eye drops three times a day.
1197741|NCT00306488|E1|Reported Event|Participant Adverse Event Information|
1197742|NCT00306384|B4|Baseline|Total|Total of all reporting groups
1197743|NCT00306384|B3|Baseline|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
1197744|NCT00306384|B2|Baseline|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
1197745|NCT00306384|B1|Baseline|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
1197746|NCT00306384|P3|Participant Flow|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
1197747|NCT00306384|P2|Participant Flow|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
1197748|NCT00306384|P1|Participant Flow|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
1197749|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
1197750|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
1197751|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
1197752|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
1197753|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
1197756|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
1197757|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
1197758|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
1198122|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1197761|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
1197762|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
1197763|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
1197764|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
1197765|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
1197766|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
1197767|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
1197768|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
1197769|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
1197770|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
1197771|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
1197772|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
1197773|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
1197774|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
1197775|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
1197776|NCT00306384|E3|Reported Event|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
1197777|NCT00306384|E2|Reported Event|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
1197778|NCT00306384|E1|Reported Event|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
1197779|NCT00306202|B4|Baseline|Total|Total of all reporting groups
1197780|NCT00306202|B3|Baseline|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
1197781|NCT00306202|B2|Baseline|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
1197782|NCT00306202|B1|Baseline|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
1197783|NCT00306202|P3|Participant Flow|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
1197784|NCT00306202|P2|Participant Flow|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
1197785|NCT00306202|P1|Participant Flow|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
1197786|NCT00306202|O1|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
1197787|NCT00306202|O1|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
1197788|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
1198123|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1197789|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
1197790|NCT00306202|O3|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
1197791|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
1197792|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
1197793|NCT00306202|O3|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
1197794|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
1197795|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
1197796|NCT00306202|O3|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
1197797|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
1197798|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
1197799|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
1197800|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
1197801|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
1197802|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
1197803|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
1197804|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
1197805|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
1197806|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
1197807|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
1197808|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
1197809|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
1198124|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1197810|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
1197811|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
1197812|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
1197813|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
1197814|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
1197815|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
1197816|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
1197817|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
1197818|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
1197819|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
1197820|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
1197821|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
1197822|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
1197823|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
1197824|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
1197825|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
1197826|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
1197827|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
1197828|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
1197829|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
1197830|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
1197831|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
1197832|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
1197833|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
1198109|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1197834|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
1197835|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
1197836|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
1197837|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2 QD Starting Dose|"Stratum 1 (Ph+ CP-CML): Participants with imatinib-resistant Ph+ CML in CP; Stratum 2/3 (PH+ ALL OR AP/BP-CML): Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in AP, or in MBP, or in LBP; or relapsed or refractory Ph+ ALL after imatinib use; or second or subsequent relapse of Ph+ AML; Stratum 4 (PH- ALL/AML): Participants with second or subsequent relapse of Ph- ALL or Ph- AML.~Strata 1, 2/3, and 4: 60 mg/m^2 starting dose; 80 mg/m^2 escalated/dose level 2; Stratum 4: 100 mg/m^2 escalated/dose level 3 and 120 mg/m^2 escalated/dose level 4. QD, as long as clinical benefit was observed."
1197838|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2 QD Starting Dose|"Stratum 1 (Ph+ CP-CML): Participants with imatinib-resistant Ph+ CML in CP; Stratum 2/3 (PH+ ALL OR AP/BP-CML): Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in AP, or in MBP, or in LBP; or relapsed or refractory Ph+ ALL after imatinib use; or second or subsequent relapse of Ph+ AML; Stratum 4 (PH- ALL/AML): Participants with second or subsequent relapse of Ph- ALL or Ph- AML.~Strata 1, 2/3, and 4: 60 mg/m^2 starting dose; 80 mg/m^2 escalated/dose level 2; Stratum 4: 100 mg/m^2 escalated/dose level 3 and 120 mg/m^2 escalated/dose level 4. QD, as long as clinical benefit was observed."
1197839|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2 QD Starting Dose|"Stratum 1 (Ph+ CP-CML): Participants with imatinib-resistant Ph+ CML in CP; Stratum 2/3 (PH+ ALL OR AP/BP-CML): Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in AP, or in MBP, or in LBP; or relapsed or refractory Ph+ ALL after imatinib use; or second or subsequent relapse of Ph+ AML; Stratum 4 (PH- ALL/AML): Participants with second or subsequent relapse of Ph- ALL or Ph- AML.~Strata 1, 2/3, and 4: 60 mg/m^2 starting dose; 80 mg/m^2 escalated/dose level 2; Stratum 4: 100 mg/m^2 escalated/dose level 3 and 120 mg/m^2 escalated/dose level 4. QD, as long as clinical benefit was observed."
1197840|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2 QD Starting Dose|"Stratum 1 (Ph+ CP-CML): Participants with imatinib-resistant Ph+ CML in CP; Stratum 2/3 (PH+ ALL OR AP/BP-CML): Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in AP, or in MBP, or in LBP; or relapsed or refractory Ph+ ALL after imatinib use; or second or subsequent relapse of Ph+ AML; Stratum 4 (PH- ALL/AML): Participants with second or subsequent relapse of Ph- ALL or Ph- AML.~Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Strata 1, 2/3, and 4: 60 mg/m^2 starting dose; 80 mg/m^2 escalated/dose level 2; Stratum 4: 100 mg/m^2 escalated/dose level 3 and 120 mg/m^2 escalated/dose level 4. QD, as long as clinical benefit was observed."
1197841|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2 QD Starting Dose|"Stratum 1 (Ph+ CP-CML): Participants with imatinib-resistant Ph+ CML in CP; Stratum 2/3 (PH+ ALL OR AP/BP-CML): Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in AP, or in MBP, or in LBP; or relapsed or refractory Ph+ ALL after imatinib use; or second or subsequent relapse of Ph+ AML; Stratum 4 (PH- ALL/AML): Participants with second or subsequent relapse of Ph- ALL or Ph- AML.~Strata 1, 2/3, and 4: 60 mg/m^2 starting dose; 80 mg/m^2 escalated/dose level 2; Stratum 4: 100 mg/m^2 escalated/dose level 3 and 120 mg/m^2 escalated/dose level 4. QD, as long as clinical benefit was observed."
1197842|NCT00306202|O3|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
1197843|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
1197844|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
1197845|NCT00306202|O3|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2.~QD, as long as clinical benefit was maintained."
1197846|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
1197847|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
1197848|NCT00306202|O2|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
1197889|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
1198110|NCT00305565|O1|Outcome|Log Dose-Response Regression Coefficient|All dosing groups
1197849|NCT00306202|O1|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
1197850|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
1197851|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
1197852|NCT00306202|O1|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
1197853|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
1197854|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
1197855|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
1197856|NCT00306202|O1|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
1197857|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2 QD, as long as clinical benefit was maintained."
1197858|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2 QD, as long as clinical benefit was maintained."
1197859|NCT00306202|O1|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2 QD, as long as clinical benefit was maintained."
1197860|NCT00306202|O4|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained.
1197861|NCT00306202|O3|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained.
1197862|NCT00306202|O2|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
1197863|NCT00306202|O1|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
1197864|NCT00306202|O2|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
1197865|NCT00306202|O1|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
1197866|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
1197867|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
1197868|NCT00306202|O2|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
1198111|NCT00305565|O1|Outcome|Log Dose-Response Regression Coefficient|All dosing groups
1197869|NCT00306202|O1|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
1197870|NCT00306202|O6|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained.
1199216|NCT00301262|O3|Outcome|DB Placebo Week 8|
1197871|NCT00306202|O5|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained.
1197872|NCT00306202|O4|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
1197873|NCT00306202|O3|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
1197874|NCT00306202|O2|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
1197875|NCT00306202|O1|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
1197876|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
1197877|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
1197878|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
1197879|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 1 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
1197880|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
1197881|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
1197882|NCT00306202|O2|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
1197883|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
1197884|NCT00306202|O4|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
1197885|NCT00306202|O3|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
1197886|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
1197887|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
1197888|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Ph+ chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
1198112|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1198113|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1197890|NCT00306202|O4|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
1198125|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1198126|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1197891|NCT00306202|O3|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
1197892|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Ph+ chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
1197893|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
1197894|NCT00306202|O8|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained.
1197895|NCT00306202|O7|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained.
1197896|NCT00306202|O6|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
1197897|NCT00306202|O5|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
1197898|NCT00306202|O4|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
1197899|NCT00306202|O3|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
1197900|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 80 mg/m^2, as long as clinical benefit was maintained."
1197901|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
1197902|NCT00306202|O8|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained.
1197903|NCT00306202|O7|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained.
1197904|NCT00306202|O6|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
1197905|NCT00306202|O5|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
1197906|NCT00306202|O4|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
1197907|NCT00306202|O3|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
1197908|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 80 mg/m^2, as long as clinical benefit was maintained."
1197909|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
1197910|NCT00306202|O8|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained.
1197911|NCT00306202|O7|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained.
1197912|NCT00306202|O6|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
1197913|NCT00306202|O5|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
1197937|NCT00306202|E3|Reported Event|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
1197914|NCT00306202|O4|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
1197915|NCT00306202|O3|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
1197916|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
1197917|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
1197918|NCT00306202|O8|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained.
1197919|NCT00306202|O7|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained.
1197920|NCT00306202|O6|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
1197921|NCT00306202|O5|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
1197922|NCT00306202|O4|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
1197923|NCT00306202|O3|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
1197924|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
1197925|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
1197926|NCT00306202|O8|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained.
1197927|NCT00306202|O7|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained.
1197928|NCT00306202|O6|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
1197929|NCT00306202|O5|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
1197930|NCT00306202|O4|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
1197931|NCT00306202|O3|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
1197932|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
1197933|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
1197934|NCT00306202|O3|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2, escalated/dose level 3 of 100 mg/m^2, escalated/dose level 3 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
1197935|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
1197936|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
1198008|NCT00305773|O1|Outcome|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
1198009|NCT00305773|O2|Outcome|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
1197938|NCT00306202|E2|Reported Event|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
1197939|NCT00306202|E1|Reported Event|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
1197940|NCT00306189|B5|Baseline|Total|Total of all reporting groups
1197941|NCT00306189|B4|Baseline|Placebo|
1197942|NCT00306189|B3|Baseline|Denosumab 100 mg Q6M|
1197943|NCT00306189|B2|Baseline|Denosumab 60 mg Q6M|
1197944|NCT00306189|B1|Baseline|Denosumab 14 mg Q6M|
1197945|NCT00306189|P4|Participant Flow|Placebo|
1197946|NCT00306189|P3|Participant Flow|Denosumab 100 mg Q6M|
1197947|NCT00306189|P2|Participant Flow|Denosumab 60 mg Q6M|
1197948|NCT00306189|P1|Participant Flow|Denosumab 14 mg Q6M|
1197949|NCT00306189|O4|Outcome|Denosumab 100 mg Q6M|
1197950|NCT00306189|O3|Outcome|Denosumab 60 mg Q6M|
1197951|NCT00306189|O2|Outcome|Denosumab 14 mg Q6M|
1197952|NCT00306189|O1|Outcome|Placebo|
1197953|NCT00306189|E4|Reported Event|Denosumab 100 mg Q6M|
1197954|NCT00306189|E3|Reported Event|Denosumab 60 mg Q6M|
1197955|NCT00306189|E2|Reported Event|Denosumab 14 mg Q6M|
1197956|NCT00306189|E1|Reported Event|Placebo|
1197957|NCT00306163|B3|Baseline|Total|Total of all reporting groups
1197958|NCT00306163|B2|Baseline|Fluticasone|100 µg, twice daily
1197959|NCT00306163|B1|Baseline|Ciclesonide|160 µg, once daily
1197960|NCT00306163|P2|Participant Flow|Fluticasone|100 µg, twice daily
1197961|NCT00306163|P1|Participant Flow|Ciclesonide|160 µg, once daily
1197962|NCT00306163|O2|Outcome|Fluticasone|100 µg, twice daily
1197963|NCT00306163|O1|Outcome|Ciclesonide|160 µg, once daily
1197964|NCT00306163|E2|Reported Event|Fluticasone|100 µg, twice daily
1197965|NCT00306163|E1|Reported Event|Ciclesonide|160 µg, once daily
1197966|NCT00305942|B1|Baseline|Topotecan/Carboplatin|Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
1197967|NCT00305942|P1|Participant Flow|Topotecan/Carboplatin|Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
1197968|NCT00305942|O1|Outcome|Topotecan/Carboplatin|Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
1197969|NCT00305942|O1|Outcome|Topotecan/Carboplatin|Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
1197970|NCT00305942|O1|Outcome|Topotecan/Carboplatin|Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
1197971|NCT00305942|E1|Reported Event|Topotecan/Carboplatin|Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
1197972|NCT00305877|B3|Baseline|Total|Total of all reporting groups
1197973|NCT00305877|B2|Baseline|Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)|Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
1197974|NCT00305877|B1|Baseline|Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)|Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
1197975|NCT00305877|P2|Participant Flow|Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)|Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
1197976|NCT00305877|P1|Participant Flow|Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)|Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
1197977|NCT00305877|O2|Outcome|Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)|Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
1197978|NCT00305877|O1|Outcome|Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)|Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
1197979|NCT00305877|O2|Outcome|Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)|Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
1197980|NCT00305877|O1|Outcome|Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)|Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
1197981|NCT00305877|O2|Outcome|Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)|Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
1197982|NCT00305877|O1|Outcome|Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)|Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
1197983|NCT00305877|E2|Reported Event|Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)|Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
1197984|NCT00305877|E1|Reported Event|Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)|Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
1197985|NCT00305864|B5|Baseline|Total|Total of all reporting groups
1197986|NCT00305864|B4|Baseline|Phase II: MGd 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1197987|NCT00305864|B3|Baseline|Phase I: MGd 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1197988|NCT00305864|B2|Baseline|Phase I: MGd 4 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1197989|NCT00305864|B1|Baseline|Phase I: MGd 3 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1197990|NCT00305864|P4|Participant Flow|Phase II: MGd 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1197991|NCT00305864|P3|Participant Flow|Phase I: MGd 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1197992|NCT00305864|P2|Participant Flow|Phase I: MGd 4 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1198007|NCT00305773|O2|Outcome|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
1198114|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1198115|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1197993|NCT00305864|P1|Participant Flow|Phase I: MGd 3 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1197994|NCT00305864|O1|Outcome|All MGd 5mg/kg Patients (Phase I and II Arms Combined)|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1197995|NCT00305864|O3|Outcome|Phase I: 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1197996|NCT00305864|O2|Outcome|Phase I: MGd 4 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1197997|NCT00305864|O1|Outcome|Phase I: MGd 3 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1197998|NCT00305864|E4|Reported Event|Phase II: MGd 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1197999|NCT00305864|E3|Reported Event|Phase I: MGd 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1198000|NCT00305864|E2|Reported Event|Phase I: MGd 4 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1198001|NCT00305864|E1|Reported Event|Phase I: MGd 3 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
1198002|NCT00305773|B3|Baseline|Total|Total of all reporting groups
1198003|NCT00305773|B2|Baseline|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
1198004|NCT00305773|B1|Baseline|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
1198005|NCT00305773|P2|Participant Flow|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
1198006|NCT00305773|P1|Participant Flow|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
1198010|NCT00305773|O1|Outcome|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
1198011|NCT00305773|O2|Outcome|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
1198012|NCT00305773|O1|Outcome|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
1198013|NCT00305773|O2|Outcome|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
1198014|NCT00305773|O1|Outcome|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
1198015|NCT00305773|O2|Outcome|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
1198016|NCT00305773|O1|Outcome|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
1198017|NCT00305773|E2|Reported Event|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
1198018|NCT00305773|E1|Reported Event|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
1198019|NCT00305760|B1|Baseline|Group 1|
1198020|NCT00305760|P1|Participant Flow|Group 1|
1198021|NCT00305760|O1|Outcome|Cyclophosphamide, Pancreatic Tumor Vaccine, Cetuximab|
1198022|NCT00305760|E1|Reported Event|Cyclophosphamide, Pancreatic Tumor Vaccine, Cetuximab|"Cetuximab: Cetuximab will be administered at an initial dose of 400 mg/m2, followed by weekly doses of 250 mg/m2 for a total of 6 cycles that last 3 weeks each.~Pancreatic tumor vaccine: Vaccine will be administered one day after cyclophosphamide (day 1) every three weeks for 6 cycles.~Cyclophosphamide: Cyclophosphamide 250 mg/m2 will be administered one day prior to vaccination (day 0) every three weeks for 6 cycles."
1198023|NCT00305643|B3|Baseline|Total|Total of all reporting groups
1198024|NCT00305643|B2|Baseline|Arm II: Placebo + Capecitabine|Arm II: Placebo with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
1198025|NCT00305643|B1|Baseline|Arm I: Celecoxib + Capecitabine|Arm I: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
1198026|NCT00305643|P2|Participant Flow|Arm II: Placebo + Capecitabine|Arm II: Placebo with standard Capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
1198027|NCT00305643|P1|Participant Flow|Arm I: Celecoxib + Capecitabine|Arm I: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
1198028|NCT00305643|O2|Outcome|Arm II: Placebo + Capecitabine|Arm II: Placebo with standard Capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
1198029|NCT00305643|O1|Outcome|Arm I: Celecoxib + Capecitabine|Arm I: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
1198030|NCT00305643|O2|Outcome|Arm II: Placebo + Capecitabine|Arm II: Placebo with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
1198031|NCT00305643|O1|Outcome|Arm I: Celecoxib + Capecitabine|Arm I: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
1198032|NCT00305643|E2|Reported Event|Arm II: Placebo + Capecitabine|Arm II: Placebo with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
1198033|NCT00305643|E1|Reported Event|Arm I: Celecoxib + Capecitabine|Arm I: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
1198034|NCT00305604|B3|Baseline|Total|Total of all reporting groups
1198035|NCT00305604|B2|Baseline|Placebo|Sitagliptin-matching placebo tablets.
1198036|NCT00305604|B1|Baseline|Sitagliptin|Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study.
1198037|NCT00305604|P2|Participant Flow|Placebo|Sitagliptin-matching placebo tablets.
1198038|NCT00305604|P1|Participant Flow|Sitagliptin|Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study.
1198039|NCT00305604|O2|Outcome|Placebo|Sitagliptin-matching placebo tablets.
1198040|NCT00305604|O1|Outcome|Sitagliptin|Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study.
1198041|NCT00305604|O2|Outcome|Placebo|Sitagliptin-matching placebo tablets.
1198042|NCT00305604|O1|Outcome|Sitagliptin|Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study.
1198043|NCT00305604|O2|Outcome|Placebo|Sitagliptin-matching placebo tablets.
1198105|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1198044|NCT00305604|O1|Outcome|Sitagliptin|Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study.
1198045|NCT00305604|O2|Outcome|Placebo|Sitagliptin-matching placebo tablets.
1198120|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1198121|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1198046|NCT00305604|O1|Outcome|Sitagliptin|Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study.
1198047|NCT00305604|E2|Reported Event|Placebo|Sitagliptin-matching placebo tablets.
1198048|NCT00305604|E1|Reported Event|Sitagliptin|Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study.
1198049|NCT00305578|B3|Baseline|Total|Total of all reporting groups
1198050|NCT00305578|B2|Baseline|Memantine|"Daily dose Memantine~Memantine : Memantine will be given orally. Subjects will be started at a dose of 5 mg for the first week and then increased by 5 mg every week up to a maximum of 20 mg depending on response and tolerance and will be kept at that level for the rest of the study. This is an 8 week study."
1198051|NCT00305578|B1|Baseline|Placebo|"Placebo daily~Placebo : No active medication, only placebo"
1198052|NCT00305578|P2|Participant Flow|Memantine|"Daily dose Memantine~Memantine : Memantine will be given orally. Subjects will be started at a dose of 5 mg for the first week and then increased by 5 mg every week up to a maximum of 20 mg depending on response and tolerance and will be kept at that level for the rest of the study. This is an 8 week study."
1198053|NCT00305578|P1|Participant Flow|Placebo|"Placebo daily~Placebo : No active medication, only placebo"
1198054|NCT00305578|O2|Outcome|Memantine|"Daily dose Memantine~Memantine : Memantine will be given orally. Subjects will be started at a dose of 5 mg for the first week and then increased by 5 mg every week up to a maximum of 20 mg depending on response and tolerance and will be kept at that level for the rest of the study. This is an 8 week study."
1198055|NCT00305578|O1|Outcome|Placebo|"Placebo daily~Placebo : No active medication, only placebo"
1198056|NCT00305578|E2|Reported Event|Memantine|"Daily dose Memantine~Memantine : Memantine will be given orally. Subjects will be started at a dose of 5 mg for the first week and then increased by 5 mg every week up to a maximum of 20 mg depending on response and tolerance and will be kept at that level for the rest of the study. This is an 8 week study."
1198057|NCT00305578|E1|Reported Event|Placebo|"Placebo daily~Placebo : No active medication, only placebo"
1198058|NCT00305565|B4|Baseline|Total|Total of all reporting groups
1198059|NCT00305565|B3|Baseline|High Dose|Received output current 1.0-1.5 mA
1198060|NCT00305565|B2|Baseline|Medium Dose|Received output current 0.5-1.0 mA
1198061|NCT00305565|B1|Baseline|Low Dose|Received output current 0.25 mA
1198062|NCT00305565|P3|Participant Flow|High Dose|Received output current 1.0-1.5 mA
1198063|NCT00305565|P2|Participant Flow|Medium Dose|Received output current 0.5-1.0 mA
1198064|NCT00305565|P1|Participant Flow|Low Dose|Received output current 0.25 milliamps (mA)
1198065|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1198066|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1198067|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1198068|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1198069|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1198070|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1198071|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1198072|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1198073|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1198074|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1198075|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1198076|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1198077|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1198078|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1198079|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1198080|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1198081|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1198082|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1198083|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1198084|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1198085|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1198086|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1198087|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1198088|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1198089|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1198090|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1198091|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1198092|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1198093|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1198094|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1198095|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1198096|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1198097|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1198098|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1198099|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1198100|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1198101|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1198102|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1198103|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1198104|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1198116|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1198117|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1198118|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1198119|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1198128|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1198129|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1198130|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1198131|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1198132|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1198133|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1198134|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1198135|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1198136|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1198137|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1198138|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1198139|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1198140|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1198141|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1198142|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1198143|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1198144|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1198145|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1198146|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1198147|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1198148|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1198149|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1198150|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1198151|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1198152|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1198153|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1198154|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1198155|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1198156|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1198157|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1198158|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1198159|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1198160|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1198161|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1198162|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1198163|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1198164|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1198165|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1198166|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1198167|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1198168|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1198169|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1198170|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1198171|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1198172|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
1198173|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
1198174|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
1198175|NCT00305565|E3|Reported Event|High Dose|Received output current 1.0-1.5 mA
1198176|NCT00305565|E2|Reported Event|Medium Dose|Received output current 0.5-1.0 mA
1198177|NCT00305565|E1|Reported Event|Low Dose|Received output current 0.25 mA
1198178|NCT00305448|B4|Baseline|Total|Total of all reporting groups
1198179|NCT00305448|B3|Baseline|Fulvestrant 500 mg|Fulvestrant 500 mg
1198180|NCT00305448|B2|Baseline|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
1198181|NCT00305448|B1|Baseline|Fulvestrant 250 mg|Fulvestrant 250 mg
1198182|NCT00305448|P3|Participant Flow|Fulvestrant 500 mg|Fulvestrant 500 mg
1198183|NCT00305448|P2|Participant Flow|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
1198184|NCT00305448|P1|Participant Flow|Fulvestrant 250 mg|Fulvestrant 250 mg
1198185|NCT00305448|O1|Outcome|Fulvestrant|Fulvestrant
1198186|NCT00305448|O1|Outcome|Fulvestrant|Fulvestrant
1198187|NCT00305448|O3|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
1198188|NCT00305448|O2|Outcome|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
1198189|NCT00305448|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg
1198190|NCT00305448|O3|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
1198191|NCT00305448|O2|Outcome|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
1198192|NCT00305448|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg
1198193|NCT00305448|O3|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
1198194|NCT00305448|O2|Outcome|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
1198195|NCT00305448|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg
1198196|NCT00305448|E3|Reported Event|Fulvestrant 500 mg|Fulvestrant 500 mg
1198197|NCT00305448|E2|Reported Event|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
1198198|NCT00305448|E1|Reported Event|Fulvestrant 250 mg|Fulvestrant 250 mg
1198199|NCT00305344|B1|Baseline|Cord Blood Recipient|Umbilical Cord Recipient
1198200|NCT00305344|P1|Participant Flow|Cord Blood Recipient|Umbilical Cord Recipient
1198201|NCT00305344|O1|Outcome|Recipients Receiving Cord Blood|Children with type 1 diabetes who underwent an autologous cord blood infusion
1198202|NCT00305344|E1|Reported Event|Cord Blood Recipients|Children with type 1 diabetes who underwent an autologous cord blood infusion
1198203|NCT00305253|B3|Baseline|Total|Total of all reporting groups
1199217|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
1198204|NCT00305253|B2|Baseline|Post-Intervention|facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.
1198205|NCT00305253|B1|Baseline|Pre-Intervention|facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.
1198206|NCT00305253|P2|Participant Flow|Post-Intervention|Post-intervention (NASG) period: patients experiencing obstetric hemorrhage were treated with standardized evidence-based protocol plus NASG.
1198207|NCT00305253|P1|Participant Flow|Pre-Intervention|Pre-intervention period: patients experiencing obstetric hemorrhage were treated with standardized evidence-based protocol.
1198208|NCT00305253|O2|Outcome|Post-Intervention|facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.
1198209|NCT00305253|O1|Outcome|Pre-Intervention|facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.
1198210|NCT00305253|O2|Outcome|Post-Intervention|facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.
1198211|NCT00305253|O1|Outcome|Pre-Intervention|facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.
1198212|NCT00305253|O2|Outcome|Post-Intervention|facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.
1198213|NCT00305253|O1|Outcome|Pre-Intervention|facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.
1198214|NCT00305253|E2|Reported Event|Post-Intervention|facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.
1198215|NCT00305253|E1|Reported Event|Pre-Intervention|facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.
1198216|NCT00305227|B3|Baseline|Total|Total of all reporting groups
1198217|NCT00305227|B2|Baseline|Placebo|Vaginal capsule - placebo. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
1198218|NCT00305227|B1|Baseline|Lactin-V|Vaginal capsule containing Lactobacillus crispatus in high concentration. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
1198219|NCT00305227|P2|Participant Flow|Placebo|Vaginal capsule - placebo. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
1198220|NCT00305227|P1|Participant Flow|Lactin-V|Vaginal capsule containing Lactobacillus crispatus in high concentration. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
1198221|NCT00305227|O2|Outcome|Placebo|Vaginal capsule - placebo. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
1198222|NCT00305227|O1|Outcome|Lactin-V|Vaginal capsule containing Lactobacillus crispatus in high concentration. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
1198223|NCT00305227|E2|Reported Event|Placebo|Vaginal capsule - placebo. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
1198224|NCT00305227|E1|Reported Event|Lactin-V|Vaginal capsule containing Lactobacillus crispatus in high concentration. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
1198225|NCT00305162|B3|Baseline|Total|Total of all reporting groups
1198226|NCT00305162|B2|Baseline|Clopidogrel Arm|clopidogrel arm: clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
1198227|NCT00305162|B1|Baseline|Cangrelor Arm|cangrelor arm: placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4mcg/kg/min) followed by clopidogrel (600 mg) post infusion
1198228|NCT00305162|P2|Participant Flow|Clopidogrel Arm|clopidogrel arm: clopidogrel capsules (600 mg)at PCI start + placebo bolus & infusion followed by placebo capsules post infusion
1198229|NCT00305162|P1|Participant Flow|Cangrelor Arm|cangrelor arm: placebo capsules at PCI start + cangrelor bolus(30 mcg/kg) & infusion (4mcg/kg/min) followed by clopidogrel (600 mg) post infusion
1198230|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
1198231|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
1198232|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
1198233|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
1198234|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
1198262|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg)at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
1198235|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
1198236|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
1198237|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
1198238|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
1198239|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
1198240|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
1198241|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
1198242|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
1198243|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
1198244|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
1198245|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
1198246|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
1198247|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
1198248|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
1198249|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
1198250|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
1198251|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
1198252|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
1198253|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
1198254|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
1198255|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
1198256|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
1198257|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
1198258|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
1198259|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
1198260|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
1198261|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
1198263|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
1198264|NCT00305162|E2|Reported Event|Clopidogrel Arm|clopidogrel arm: clopidogrel capsules (600 mg)at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
1198265|NCT00305162|E1|Reported Event|Cangrelor Arm|cangrelor arm: placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4mcg/kg/min) followed by clopidogrel (600 mg) post infusion
1198266|NCT00304954|B5|Baseline|Total|Total of all reporting groups
1198381|NCT00304031|P3|Participant Flow|Dose-dense Adjuvant TMZ|Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
1198267|NCT00304954|B4|Baseline|Observation|Participants randomly assigned to the observation group were given injections of either bevacizumab (1.25 mg/0.05 mL or 2.5 mg/0.1 mL) or ranibizumab (0.5 mg) if they presented with recurrence of intraretinal or subretinal fluid as seen on Stratus Optical Coherence Tomography.
1198268|NCT00304954|B3|Baseline|Oral Rapamycin|Participants randomly assigned to rapamycin received 2 mg in capsule form every other day for 6 months.
1198269|NCT00304954|B2|Baseline|Intravenous Infliximab|Participants randomized to IV infliximab received 3 mg/kg of IV infliximab monthly for 6 months.
1198270|NCT00304954|B1|Baseline|Intravenous Daclizumab|Participants randomly assigned to intravenous (IV) daclizumab received 8 mg/kg of IV daclizumab at baseline, then 4 mg/kg of IV daclizumab at Week 2 and then 2 mg/kg of IV daclizumab monthly for the rest of the 6-month study.
1198271|NCT00304954|P4|Participant Flow|Observation|Participants randomly assigned to the observation group were given injections of either bevacizumab (1.25 mg/0.05 mL or 2.5 mg/0.1 mL) or ranibizumab (0.5 mg) if they presented with recurrence of intraretinal or subretinal fluid as seen on Stratus Optical Coherence Tomography.
1198272|NCT00304954|P3|Participant Flow|Oral Rapamycin|Participants randomly assigned to rapamycin received 2 mg in capsule form every other day for 6 months.
1198273|NCT00304954|P2|Participant Flow|Intravenous Infliximab|Participants randomized to IV infliximab received 3 mg/kg of IV infliximab monthly for 6 months.
1198274|NCT00304954|P1|Participant Flow|Intravenous Daclizumab|Participants randomly assigned to intravenous (IV) daclizumab received 8 mg/kg of IV daclizumab at baseline, then 4 mg/kg of IV daclizumab at Week 2 and then 2 mg/kg of IV daclizumab monthly for the rest of the 6-month study.
1198275|NCT00304954|O4|Outcome|Sixth-Month OCT - Fellow Eye|
1198276|NCT00304954|O3|Outcome|Baseline OCT - Fellow Eye|
1198277|NCT00304954|O2|Outcome|Sixth-Month OCT - Study Eye|
1198278|NCT00304954|O1|Outcome|Baseline OCT - Study Eye|
1198279|NCT00304954|O4|Outcome|Sixth-Month Vision - Fellow Eye|
1198280|NCT00304954|O3|Outcome|Baseline Vision - Fellow Eye|
1198281|NCT00304954|O2|Outcome|Sixth-Month Vision - Study Eye|
1198282|NCT00304954|O1|Outcome|Baseline Vision - Study Eye|
1198283|NCT00304954|O4|Outcome|Observation|Participants randomly assigned to the observation group were given injections of either bevacizumab (1.25 mg/0.05 mL or 2.5 mg/0.1 mL) or ranibizumab (0.5 mg) if they presented with recurrence of intraretinal or subretinal fluid as seen on Stratus Optical Coherence Tomography.
1198284|NCT00304954|O3|Outcome|Oral Rapamycin|Participants randomly assigned to rapamycin received 2 mg in capsule form every other day for 6 months.
1198285|NCT00304954|O2|Outcome|Intravenous Infliximab|Participants randomized to IV infliximab received 3 mg/kg of IV infliximab monthly for 6 months.
1198286|NCT00304954|O1|Outcome|Intravenous Daclizumab|Participants randomly assigned to intravenous (IV) daclizumab received 8 mg/kg of IV daclizumab at baseline, then 4 mg/kg of IV daclizumab at Week 2 and then 2 mg/kg of IV daclizumab monthly for the rest of the 6-month study.
1198287|NCT00304954|E4|Reported Event|Observation|Participants randomly assigned to the observation group were given injections of either bevacizumab (1.25 mg/0.05 mL or 2.5 mg/0.1 mL) or ranibizumab (0.5 mg) if they presented with recurrence of intraretinal or subretinal fluid as seen on Stratus Optical Coherence Tomography.
1198288|NCT00304954|E3|Reported Event|Oral Rapamycin|Participants randomly assigned to rapamycin received 2 mg in capsule form every other day for 6 months.
1198289|NCT00304954|E2|Reported Event|Intravenous Infliximab|Participants randomized to IV infliximab received 3 mg/kg of IV infliximab monthly for 6 months.
1198290|NCT00304954|E1|Reported Event|Intravenous Daclizumab|Participants randomly assigned to intravenous (IV) daclizumab received 8 mg/kg of IV daclizumab at baseline, then 4 mg/kg of IV daclizumab at Week 2 and then 2 mg/kg of IV daclizumab monthly for the rest of the 6-month study.
1198291|NCT00304915|B3|Baseline|Total|Total of all reporting groups
1198292|NCT00304915|B2|Baseline|Arm 2: Usual Care|Usual care arm. Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The HI-TIDES depression care team will not be a part of the usual care condition.
1198293|NCT00304915|B1|Baseline|Arm 1: Collaborative Care Intervention|Collaborative Care Intervention: Patients in the intervention group will be supported by a depression collaborative care team that will include a depression nurse care manager, clinical pharmacist, and psychiatrist. The depression nurse care manager will evaluate depression symptom severity, antidepressant side effects, depression and HIV medication adherence every two weeks over the phone during the acute phase of treatment and will record these results in CPRS. After a 50% improvement in depression severity, the intervention subject will move into the continuation phase of treatment and the patient will be contacted every four weeks by the depression nurse case manager.
1198294|NCT00304915|P2|Participant Flow|Arm 2: Usual Care|Usual care arm. Usual care will include depression screening with the same 9-item Patient Health Questionnaire (PHQ-9) screener used for Arm 1. The HI-TIDES depression care team will not be a part of the usual care condition.
1198295|NCT00304915|P1|Participant Flow|Arm 1: Collaborative Care Intervention|Collaborative Care Intervention: Patients in the intervention group will be supported by a depression collaborative care team that will include a depression nurse care manager, clinical pharmacist, and psychiatrist. The depression nurse care manager will evaluate depression symptom severity, antidepressant side effects, depression and HIV medication adherence every two weeks over the phone during the acute phase of treatment and will record these results in VA electronic medical record. After a 50% improvement in depression severity, the intervention subject will move into the continuation phase of treatment and the patient will be contacted every four weeks by the depression nurse case manager.
1198296|NCT00304915|O2|Outcome|Arm 2: Usual Care|Usual care arm. Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The HI-TIDES depression care team will not be a part of the usual care condition.
1198327|NCT00304265|E2|Reported Event|5th Dose Pertussis Vaccine Group|Participants who had received at least 3 doses of whole-cell pertussis vaccine during infant immunization and at least 1 subsequent booster vaccination in the 2nd to 7th years of life received either REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 5th (booster) dose as adolescents.
1198688|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
1198297|NCT00304915|O1|Outcome|Arm 1: Collaborative Care Intervention|Collaborative Care Intervention: Patients in the intervention group will be supported by a depression collaborative care team that will include a depression nurse care manager, clinical pharmacist, and psychiatrist. The depression nurse care manager will evaluate depression symptom severity, antidepressant side effects, depression and HIV medication adherence every two weeks over the phone during the acute phase of treatment and will record these results in CPRS. After a 50% improvement in depression severity, the intervention subject will move into the continuation phase of treatment and the patient will be contacted every four weeks by the depression nurse case manager.
1198298|NCT00304915|E2|Reported Event|Arm 2: Usual Care|Usual care arm. Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The HI-TIDES depression care team will not be a part of the usual care condition.
1198299|NCT00304915|E1|Reported Event|Arm 1: Collaborative Care Intervention|Collaborative Care Intervention: Patients in the intervention group will be supported by a depression collaborative care team that will include a depression nurse care manager, clinical pharmacist, and psychiatrist. The depression nurse care manager will evaluate depression symptom severity, antidepressant side effects, depression and HIV medication adherence every two weeks over the phone during the acute phase of treatment and will record these results in CPRS. After a 50% improvement in depression severity, the intervention subject will move into the continuation phase of treatment and the patient will be contacted every four weeks by the depression nurse case manager.
1198300|NCT00304746|B3|Baseline|Total|Total of all reporting groups
1198301|NCT00304746|B2|Baseline|Placebo Gel|Placebo gel identical in appearance to the testosterone gel
1198302|NCT00304746|B1|Baseline|Testosterone Gel|AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
1198303|NCT00304746|P2|Participant Flow|Placebo Gel|Placebo gel identical in appearance to the testosterone gel
1198304|NCT00304746|P1|Participant Flow|Testosterone Gel|AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
1198305|NCT00304746|O2|Outcome|Placebo Gel|Placebo gel identical in appearance to the testosterone gel
1198306|NCT00304746|O1|Outcome|Testosterone Gel|AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
1198307|NCT00304746|O2|Outcome|Placebo Gel|Placebo gel identical in appearance to the testosterone gel
1198308|NCT00304746|O1|Outcome|Testosterone Gel|AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
1198309|NCT00304746|E2|Reported Event|Placebo Gel|Placebo gel identical in appearance to the testosterone gel
1198310|NCT00304746|E1|Reported Event|Testosterone Gel|AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
1198311|NCT00304707|B3|Baseline|Total|Total of all reporting groups
1198312|NCT00304707|B2|Baseline|Placebo|"placebo~placebo: placebo"
1198313|NCT00304707|B1|Baseline|Bupropion 300-mg Capsules|"participants in this arm receive bupropion~Bupropion: 300 mg QD"
1198314|NCT00304707|P2|Participant Flow|Placebo|"placebo~placebo: placebo"
1198315|NCT00304707|P1|Participant Flow|Bupropion 300-mg Capsules|"participants in this arm receive bupropion~Bupropion: 300 mg QD"
1198316|NCT00304707|O2|Outcome|Placebo|"placebo~placebo: placebo"
1198317|NCT00304707|O1|Outcome|Bupropion 300-mg Capsules|"participants in this arm receive bupropion~Bupropion: 300 mg QD"
1198318|NCT00304707|E2|Reported Event|Placebo|"placebo~placebo: placebo"
1198319|NCT00304707|E1|Reported Event|Bupropion 300-mg Capsules|"participants in this arm receive bupropion~Bupropion: 300 mg QD"
1198320|NCT00304265|B3|Baseline|Total|Total of all reporting groups
1198321|NCT00304265|B2|Baseline|5th Dose Pertussis Vaccine Group|Participants who had received at least 3 doses of whole-cell pertussis vaccine during infant immunization and at least 1 subsequent booster vaccination in the 2nd to 7th years of life received either REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 5th (booster) dose as adolescents.
1198322|NCT00304265|B1|Baseline|6th Dose Pertussis Vaccine Group|Participants who had received 5 doses of BIKEN acellular pertussis vaccine in Study 371-03/01 received REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 6th (booster) dose as adolescents.
1198323|NCT00304265|P2|Participant Flow|5th Dose Pertussis Vaccine Group|Participants who had received at least 3 doses of whole-cell pertussis vaccine during infant immunization and at least 1 subsequent booster vaccination in the 2nd to 7th years of life received either REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 5th (booster) dose as adolescents.
1198324|NCT00304265|P1|Participant Flow|6th Dose Pertussis Vaccine Group|Participants who had received 5 doses of BIKEN acellular pertussis vaccine in Study 371-03/01 received REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 6th (booster) dose as adolescents.
1198325|NCT00304265|O2|Outcome|5th Dose Pertussis Vaccine Group|Participants who had received at least 3 doses of whole-cell pertussis vaccine during infant immunization and at least 1 subsequent booster vaccination in the 2nd to 7th years of life received either REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 5th (booster) dose as adolescents.
1198326|NCT00304265|O1|Outcome|6th Dose Pertussis Vaccine Group|Participants who had received 5 doses of BIKEN acellular pertussis vaccine in Study 371-03/01 received REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 6th (booster) dose as adolescents.
1198375|NCT00304070|O1|Outcome|Stratum 1|Stage I Disease (surgery, observation)
1198376|NCT00304070|E1|Reported Event|Stratum 3|Stage III OR IV Disease (chemotherapy)
1198377|NCT00304031|B4|Baseline|Total|Total of all reporting groups
1199121|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
1198380|NCT00304031|B1|Baseline|No Adjuvant TMZ (Not Randomized )|Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Not randomized to either adjuvant TMZ arm.
1198328|NCT00304265|E1|Reported Event|6th Dose Pertussis Vaccine Group|Participants who had received 5 doses of BIKEN acellular pertussis vaccine in Study 371-03/01 received REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 6th (booster) dose as adolescents.
1198329|NCT00304187|B3|Baseline|Total|Total of all reporting groups
1198330|NCT00304187|B2|Baseline|Placebo|"Participants will take matched placebo.~Placebo : Placebo, 250 mg or 500 mg, three times a day for 6 weeks"
1198331|NCT00304187|B1|Baseline|Erythromycin|"Subjects with Bulimia Nervosa will take erythromycin.~Erythromycin : Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks"
1198332|NCT00304187|P2|Participant Flow|Placebo|"Participants will take matched placebo.~Placebo : Placebo, 250 mg or 500 mg, three times a day for 6 weeks"
1198333|NCT00304187|P1|Participant Flow|Erythromycin|"Subjects with Bulimia Nervosa will take erythromycin.~Erythromycin : Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks"
1198334|NCT00304187|O2|Outcome|Placebo|"Participants will take matched placebo.~Placebo : Placebo, 250 mg or 500 mg, three times a day for 6 weeks"
1198335|NCT00304187|O1|Outcome|Erythromycin|"Subjects with Bulimia Nervosa will take erythromycin.~Erythromycin : Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks"
1198336|NCT00304187|E2|Reported Event|Placebo|"Participants will take matched placebo.~Placebo : Placebo, 250 mg or 500 mg, three times a day for 6 weeks"
1198337|NCT00304187|E1|Reported Event|Erythromycin|"Subjects with Bulimia Nervosa will take erythromycin.~Erythromycin : Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks"
1198338|NCT00304161|B3|Baseline|Total|Total of all reporting groups
1198339|NCT00304161|B2|Baseline|Placebo|Participants will receive placebo treatment
1198340|NCT00304161|B1|Baseline|Atomoxetine|Participants will receive atomoxetine treatment
1198341|NCT00304161|P2|Participant Flow|Placebo|Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.
1198342|NCT00304161|P1|Participant Flow|Atomoxetine|Participants will receive 40-80mgs of atomoxetine orally once daily.
1198343|NCT00304161|O2|Outcome|Placebo|Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.
1198344|NCT00304161|O1|Outcome|Atomoxetine|Participants will receive 40-80mgs of atomoxetine orally once daily.
1198345|NCT00304161|O2|Outcome|Placebo|Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.
1198346|NCT00304161|O1|Outcome|Atomoxetine|Participants will receive 40-80mgs of atomoxetine orally once daily.
1198347|NCT00304161|E2|Reported Event|Placebo|Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.
1198348|NCT00304161|E1|Reported Event|Atomoxetine|Participants will receive 40-80mgs of atomoxetine orally once daily.
1198349|NCT00304096|B3|Baseline|Total|Total of all reporting groups
1198350|NCT00304096|B2|Baseline|Stratum 2: Had Not Received Hormonal Therapy|Participants had not received hormonal therapy
1198351|NCT00304096|B1|Baseline|Stratum 1: Received Hormonal Therapy|Participants received hormonal therapy
1198352|NCT00304096|P2|Participant Flow|Stratum 2: Had Not Received Hormonal Therapy|Participants had not received hormonal therapy
1198353|NCT00304096|P1|Participant Flow|Stratum 1: Received Hormonal Therapy|Participants received hormonal therapy
1198354|NCT00304096|O2|Outcome|Stratum 2: Had Not Received Hormonal Therapy|Participants had not received hormonal therapy
1198355|NCT00304096|O1|Outcome|Stratum 1: Received Hormonal Therapy|Participants received hormonal therapy
1198356|NCT00304096|O2|Outcome|Stratum 2: Had Not Received Hormonal Therapy|Participants had not received hormonal therapy
1198357|NCT00304096|O1|Outcome|Stratum 1: Received Hormonal Therapy|Participants received hormonal therapy
1198358|NCT00304096|E2|Reported Event|Stratum 2: Had Not Received Hormonal Therapy|Participants had not received hormonal therapy
1198359|NCT00304096|E1|Reported Event|Stratum 1: Received Hormonal Therapy|Participants received hormonal therapy
1198360|NCT00304070|B4|Baseline|Total|Total of all reporting groups
1198361|NCT00304070|B3|Baseline|Stratum 3|Stage III OR IV Disease (chemotherapy)
1198362|NCT00304070|B2|Baseline|Stratum 2|Stage II Disease (surgery, observation)
1198363|NCT00304070|B1|Baseline|Stratum 1|Stage I Disease (surgery, observation)
1198364|NCT00304070|P3|Participant Flow|Stratum 3|Stage III OR IV Disease (chemotherapy)
1198365|NCT00304070|P2|Participant Flow|Stratum 2|Stage II Disease (surgery, observation)
1198366|NCT00304070|P1|Participant Flow|Stratum 1|Stage I Disease (surgery, observation)
1198367|NCT00304070|O1|Outcome|All Patients|The number of eligible patients who have surgical resection of the primary tumor and have tumor spillage at the time of resection.
1198368|NCT00304070|O1|Outcome|All Patients|Regardless of Arm/Group assignment, the number of eligible patients who had surgery at study enrollment and have A43 del33bp mutation of (beta)-catenins.
1198369|NCT00304070|O1|Outcome|All Patients|Regardless of Arm/Group assignment, the number of eligible patients from whom blood was obtained as well as the frequency of the relevant mutation in each group.
1198370|NCT00304070|O1|Outcome|All Patients|Regardless of Arm/Group assignment, the frequency reflects the total number of patients who had lymph node involvement by imaging at study enrollment.
1198371|NCT00304070|O1|Outcome|All Patients|The complication rate is estimated as the proportion of evaluable patients that have a complication as it relates to surgery.
1198372|NCT00304070|O1|Outcome|Stratum 3|Stage III OR IV Disease (chemotherapy)
1198373|NCT00304070|O3|Outcome|Stratum 3|Stage III OR IV Disease (chemotherapy)
1198374|NCT00304070|O2|Outcome|Stratum 2|Stage II Disease (surgery, observation)
1198378|NCT00304031|B3|Baseline|Dose-dense Adjuvant TMZ|Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
1198379|NCT00304031|B2|Baseline|Conventional Adjuvant TMZ|Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.
1198382|NCT00304031|P2|Participant Flow|Conventional Adjuvant TMZ|Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.
1198383|NCT00304031|P1|Participant Flow|No Adjuvant TMZ (Not Randomized)|Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Not randomized to either adjuvant TMZ arm.
1198384|NCT00304031|O2|Outcome|Dose-dense Adjuvant TMZ|Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
1198385|NCT00304031|O1|Outcome|Conventional Adjuvant TMZ|Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.
1198386|NCT00304031|E3|Reported Event|Dose-dense Adjuvant TMZ|"Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.~Concurrent temozolomide: Daily oral temozolomide (75 mg/m2) up to 49 doses.~Concurrent radiation therapy: 60 Gy in 2 Gy fractions~75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle: Oral temozolomide on days 1-21 of a 28-day cycle. Dose starts at 75mg/m2 for first cycle, increases to 100mg/m2 for subsequent cycles if no unacceptable toxicity. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease may receive up to 6 more courses of temozolomide."
1198387|NCT00304031|E2|Reported Event|Conventional Adjuvant TMZ|"Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.~Concurrent temozolomide: Daily oral temozolomide (75 mg/m2) up to 49 doses.~Concurrent radiation therapy: 60 Gy in 2 Gy fractions~100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle: Oral temozolomide on days 1-5 of a 28-day cycle. Dose starts at 150mg/m2 for first cycle, increases to 200mg/m2 for subsequent cycles if no unacceptable toxicity. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease may receive up to 6 more courses of temozolomide."
1198388|NCT00304031|E1|Reported Event|No Adjuvant TMZ (Not Randomized)|"Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Not randomized to either adjuvant TMZ arm.~Concurrent temozolomide: Daily oral temozolomide (75 mg/m2) up to 49 doses.~Concurrent radiation therapy: 60 Gy in 2 Gy fractions"
1198389|NCT00303979|B4|Baseline|Total|Total of all reporting groups
1198390|NCT00303979|B3|Baseline|Cohort C (18 Month)|"18 Month Cohort: Approximately 10,000 patients reviewed at single time point~Evidence based guidelines and tools : Education, guidelines, tools"
1198391|NCT00303979|B2|Baseline|Cohort B (6 Month)|"6 Month Cohort: Approximately 10,000 patients reviewed at single time point~Evidence based guidelines and tools : Education, guidelines, tools"
1198392|NCT00303979|B1|Baseline|Cohort A (Longitudinal)|"Longitudinal Cohort: Approximately 15,000 patients followed at baseline, 12 months and 24 months~Evidence based guidelines and tools : Education, guidelines, tools"
1198393|NCT00303979|P3|Participant Flow|Cohort C (18 Month)|"18 Month Cohort: Approximately 10,000 patients reviewed at single time point~Evidence based guidelines and tools : Education, guidelines, tools"
1198394|NCT00303979|P2|Participant Flow|Cohort B (6 Month)|"6 Month Cohort: Approximately 10,000 patients reviewed at single time point~Evidence based guidelines and tools : Education, guidelines, tools"
1198395|NCT00303979|P1|Participant Flow|Cohort A (Longitudinal)|"Longitudinal Cohort: Approximately 15,000 patients followed at baseline, 12 months and 24 months~Evidence based guidelines and tools : Education, guidelines, tools"
1198396|NCT00303979|O1|Outcome|Cohort C (18 Month)|The number of sites in Cohort C.
1198397|NCT00303979|O1|Outcome|Cohort B (6 Month)|Number of sites in Cohort B (6 Month).
1198398|NCT00303979|O1|Outcome|Corhort A (Longitudinal)|The number of sites in Cohort A.
1198399|NCT00303979|O1|Outcome|Corhort A (Longitudinal)|The number of sites in Cohort A.
1198400|NCT00303979|O1|Outcome|Cohort A (Longitudinal)|"For this longitudinal cohort, data are collected at baseline, 12 months and 24 months after the principle investigator and HF nurse attend an educational workshop. All longitudinal analyses will be performed on this cohort of patients. There will be two analysis sets from this cohort:~All Patients: All patients with baseline data Completers: Patients who have a qualifying visit at both baseline and 24 months who were living at the 24 month chart review and are qualified for at least one performance measure at 24 months."
1198401|NCT00303979|E3|Reported Event|Cohort C (18 Month)|"18 Month Cohort: Approximately 10,000 patients reviewed at single time point~Evidence based guidelines and tools : Education, guidelines, tools"
1198402|NCT00303979|E2|Reported Event|Cohort B (6 Month)|"6 Month Cohort: Approximately 10,000 patients reviewed at single time point~Evidence based guidelines and tools : Education, guidelines, tools"
1198403|NCT00303979|E1|Reported Event|Cohort A (Longitudinal)|"Longitudinal Cohort: Approximately 15,000 patients followed at baseline, 12 months and 24 months~Evidence based guidelines and tools : Education, guidelines, tools"
1198404|NCT00303966|B1|Baseline|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1198405|NCT00303966|P1|Participant Flow|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1198444|NCT00303823|E2|Reported Event|Placebo|
1198445|NCT00303823|E1|Reported Event|Polyphenon E|
1198406|NCT00303966|O1|Outcome|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1198407|NCT00303966|O1|Outcome|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1198408|NCT00303966|O1|Outcome|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1198409|NCT00303966|O1|Outcome|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1198410|NCT00303966|O1|Outcome|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1198411|NCT00303966|O1|Outcome|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1198412|NCT00303966|E1|Reported Event|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
1198413|NCT00303953|B1|Baseline|PXD101|Only eligible patients were included in the analyses. Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
1198414|NCT00303953|P1|Participant Flow|PXD101|Only eligible patients were included in the analyses. Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
1198415|NCT00303953|O1|Outcome|PXD101|Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
1198416|NCT00303953|O1|Outcome|PXD101|Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
1198417|NCT00303953|O1|Outcome|PXD101|Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
1198418|NCT00303953|E1|Reported Event|PXD101|Only eligible patients were included in the analyses. Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
1198419|NCT00303901|B1|Baseline|Cryosurgery|"cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.~cryosurgery~positron emission tomography"
1198420|NCT00303901|P1|Participant Flow|Cryosurgery|"cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.~cryosurgery~positron emission tomography"
1198421|NCT00303901|O1|Outcome|Cryosurgery|"cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.~cryosurgery~positron emission tomography"
1198422|NCT00303901|O1|Outcome|Cryosurgery|"cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.~cryosurgery~positron emission tomography"
1198423|NCT00303901|E1|Reported Event|Cryosurgery|"cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.~cryosurgery~positron emission tomography"
1198424|NCT00303862|B1|Baseline|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
1198425|NCT00303862|P1|Participant Flow|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
1198426|NCT00303862|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
1198427|NCT00303862|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
1198428|NCT00303862|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
1198429|NCT00303862|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
1198430|NCT00303862|E1|Reported Event|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
1198431|NCT00303823|B3|Baseline|Total|Total of all reporting groups
1198432|NCT00303823|B2|Baseline|Placebo|
1198433|NCT00303823|B1|Baseline|Polyphenon E|
1198434|NCT00303823|P2|Participant Flow|Placebo|Patients receive oral placebo once daily for 16 weeks
1198435|NCT00303823|P1|Participant Flow|Polyphenon E (Defined Green Tea Catechin Extract)|Patients receive oral Polyphenon E daily for 16 weeks
1198436|NCT00303823|O2|Outcome|Placebo|
1198437|NCT00303823|O1|Outcome|Polyphenon E|
1198438|NCT00303823|O2|Outcome|Placebo|
1198439|NCT00303823|O1|Outcome|Polyphenon E|
1198440|NCT00303823|O2|Outcome|Placebo|
1198441|NCT00303823|O1|Outcome|Polyphenon E|
1198442|NCT00303823|O2|Outcome|Placebo|
1198443|NCT00303823|O1|Outcome|Polyphenon E|
1198447|NCT00303667|B2|Baseline|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
1198448|NCT00303667|B1|Baseline|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
1198689|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
1198690|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
1198449|NCT00303667|P2|Participant Flow|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
1198450|NCT00303667|P1|Participant Flow|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
1198451|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
1198452|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
1198453|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
1198454|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
1198455|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
1198456|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
1198457|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
1198458|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
1198459|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
1198460|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
1198461|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
1198462|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
1198463|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
1198464|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
1198465|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
1198466|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
1198467|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
1198468|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
1198469|NCT00303667|E2|Reported Event|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
1198470|NCT00303667|E1|Reported Event|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
1198471|NCT00303628|B3|Baseline|Total|Total of all reporting groups
1198472|NCT00303628|B2|Baseline|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV~bevacizumab: Given IV"
1198473|NCT00303628|B1|Baseline|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV"
1198474|NCT00303628|P2|Participant Flow|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV~bevacizumab: Given IV"
1198475|NCT00303628|P1|Participant Flow|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV"
1198476|NCT00303628|O2|Outcome|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV~bevacizumab: Given IV"
1198477|NCT00303628|O1|Outcome|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV"
1198478|NCT00303628|O2|Outcome|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV~bevacizumab: Given IV"
1198479|NCT00303628|O1|Outcome|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV"
1198480|NCT00303628|O2|Outcome|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV~bevacizumab: Given IV"
1198481|NCT00303628|O1|Outcome|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV"
1198482|NCT00303628|O2|Outcome|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV~bevacizumab: Given IV"
1198483|NCT00303628|O1|Outcome|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV"
1198484|NCT00303628|O2|Outcome|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV~bevacizumab: Given IV"
1198485|NCT00303628|O1|Outcome|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV"
1198486|NCT00303628|O2|Outcome|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV~bevacizumab: Given IV"
1198487|NCT00303628|O1|Outcome|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV"
1198488|NCT00303628|E2|Reported Event|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I
1198691|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
1198692|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
1198489|NCT00303628|E1|Reported Event|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|Patients receive oxaliplatin intravenously (IV) over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses* in the absence of disease progression or unacceptable toxicity.
1198490|NCT00303602|B3|Baseline|Total|Total of all reporting groups
1198491|NCT00303602|B2|Baseline|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
1198492|NCT00303602|B1|Baseline|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
1198493|NCT00303602|P2|Participant Flow|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
1198494|NCT00303602|P1|Participant Flow|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
1198495|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
1198496|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
1198497|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
1198498|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
1198499|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
1198500|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
1198501|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
1198502|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
1198503|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
1198504|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
1198505|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
1198506|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
1198507|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
1198508|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
1198509|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
1198510|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
1198511|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
1198512|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
1198513|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
1198514|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
1198515|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
1198516|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
1198517|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
1198518|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
1198519|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
1198681|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
1198682|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
1198520|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
1198521|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
1198693|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
1198694|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
1198522|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
1198523|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
1198524|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
1198525|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
1198526|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
1198527|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
1198528|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
1198529|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
1198530|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
1198531|NCT00303602|E2|Reported Event|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
1198532|NCT00303602|E1|Reported Event|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
1198533|NCT00303511|B1|Baseline|ACHD With Pacemaker|
1198534|NCT00303511|P1|Participant Flow|ACHD With Pacemaker|
1198535|NCT00303511|O1|Outcome|Cohort|
1198536|NCT00303511|E1|Reported Event|ACHD With Pacemaker|
1198537|NCT00303485|B3|Baseline|Total|Total of all reporting groups
1198538|NCT00303485|B2|Baseline|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
1198539|NCT00303485|B1|Baseline|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
1198540|NCT00303485|P2|Participant Flow|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
1198541|NCT00303485|P1|Participant Flow|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
1198542|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
1198543|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
1198544|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
1198545|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
1198546|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
1198547|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
1198548|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
1198549|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
1198550|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
1198551|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
1198552|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
1198553|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
1198554|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
1198695|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
1198696|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
1198555|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
1198556|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
1198557|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
1198558|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
1198559|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
1198560|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
1198561|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
1198562|NCT00303485|E2|Reported Event|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
1198563|NCT00303485|E1|Reported Event|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
1198564|NCT00303472|B8|Baseline|Total|Total of all reporting groups
1198565|NCT00303472|B7|Baseline|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
1198566|NCT00303472|B6|Baseline|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
1198567|NCT00303472|B5|Baseline|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198568|NCT00303472|B4|Baseline|Part A: 1500 µg Romiplostim|Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198569|NCT00303472|B3|Baseline|Part A: 1000 µg Romiplostim|Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198570|NCT00303472|B2|Baseline|Part A: 700 µg Romiplostim|Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198571|NCT00303472|B1|Baseline|Part A: 300 µg Romiplostim|Cohort 1 in Part A, participants received romiplostim 300 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198572|NCT00303472|P7|Participant Flow|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
1198573|NCT00303472|P6|Participant Flow|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
1198574|NCT00303472|P5|Participant Flow|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198575|NCT00303472|P4|Participant Flow|Part A: 1500 µg Romiplostim|Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198576|NCT00303472|P3|Participant Flow|Part A: 1000 µg Romiplostim|Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198577|NCT00303472|P2|Participant Flow|Part A: 700 µg Romiplostim|Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198578|NCT00303472|P1|Participant Flow|Part A: 300 µg Romiplostim|Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198579|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
1198580|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
1198581|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198582|NCT00303472|O4|Outcome|Part A: 1500 µg Romiplostim|Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198583|NCT00303472|O3|Outcome|Part A: 1000 µg Romiplostim|Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198584|NCT00303472|O2|Outcome|Part A: 700 µg Romiplostim|Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198585|NCT00303472|O1|Outcome|Part A: 300 µg Romiplostim|Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198586|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
1198587|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198588|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
1198589|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198590|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
1198591|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198592|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
1198593|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198594|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
1198595|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198596|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
1198597|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
1198598|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198599|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
1198600|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
1198601|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198602|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
1198603|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
1198683|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
1198604|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198605|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
1198606|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
1198607|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198608|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
1198609|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
1198610|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198611|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
1198612|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
1198613|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198614|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
1198615|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
1198616|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198617|NCT00303472|O4|Outcome|Part A: 1500 µg Romiplostim|Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198618|NCT00303472|O3|Outcome|Part A: 1000 µg Romiplostim|Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198619|NCT00303472|O2|Outcome|Part A: 700 µg Romiplostim|Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198620|NCT00303472|O1|Outcome|Part A: 300 µg Romiplostim|Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198621|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
1198622|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
1198623|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198624|NCT00303472|O4|Outcome|Part A: 1500 µg Romiplostim|Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198625|NCT00303472|O3|Outcome|Part A: 1000 µg Romiplostim|Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198626|NCT00303472|O2|Outcome|Part A: 700 µg Romiplostim|Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198627|NCT00303472|O1|Outcome|Part A: 300 µg Romiplostim|Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198684|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
1198628|NCT00303472|E7|Reported Event|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
1198629|NCT00303472|E6|Reported Event|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
1198630|NCT00303472|E5|Reported Event|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198631|NCT00303472|E4|Reported Event|Part A: 1500 µg Romiplostim|Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198632|NCT00303472|E3|Reported Event|Part A: 1000 µg Romiplostim|Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198633|NCT00303472|E2|Reported Event|Part A: 700 µg Romiplostim|Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198634|NCT00303472|E1|Reported Event|Part A: 300 µg Romiplostim|Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
1198635|NCT00303459|B3|Baseline|Total|Total of all reporting groups
1198636|NCT00303459|B2|Baseline|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
1198637|NCT00303459|B1|Baseline|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
1198638|NCT00303459|P2|Participant Flow|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
1198639|NCT00303459|P1|Participant Flow|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet, twice a day (b.i.d.) for 4 weeks then bosentan/125 mg tablet/b.i.d."
1198640|NCT00303459|O2|Outcome|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
1198641|NCT00303459|O1|Outcome|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
1198642|NCT00303459|O2|Outcome|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
1198643|NCT00303459|O1|Outcome|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
1198644|NCT00303459|O2|Outcome|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
1198645|NCT00303459|O1|Outcome|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
1198646|NCT00303459|O2|Outcome|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
1198647|NCT00303459|O1|Outcome|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
1198648|NCT00303459|O2|Outcome|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
1198649|NCT00303459|O1|Outcome|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet, b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
1198650|NCT00303459|O2|Outcome|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
1198651|NCT00303459|O1|Outcome|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
1198652|NCT00303459|O2|Outcome|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
1198653|NCT00303459|O1|Outcome|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
1198654|NCT00303459|O2|Outcome|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
1198655|NCT00303459|O1|Outcome|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
1198656|NCT00303459|O2|Outcome|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
1198657|NCT00303459|O1|Outcome|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
1198658|NCT00303459|O2|Outcome|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
1198659|NCT00303459|O1|Outcome|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
1198660|NCT00303459|E2|Reported Event|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
1198661|NCT00303459|E1|Reported Event|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
1198662|NCT00303446|B3|Baseline|Total|Total of all reporting groups
1198663|NCT00303446|B2|Baseline|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
1198664|NCT00303446|B1|Baseline|Placebo|Matched placebo, one tablet daily
1198665|NCT00303446|P2|Participant Flow|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
1198666|NCT00303446|P1|Participant Flow|Placebo|Matched placebo, one tablet daily
1198667|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
1198668|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
1198669|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
1198670|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
1198671|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
1198672|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
1198673|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
1198674|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
1198675|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
1198676|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
1198677|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
1198678|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
1198679|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
1198685|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
1198686|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
1198687|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
1198697|NCT00303446|E2|Reported Event|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
1198698|NCT00303446|E1|Reported Event|Placebo|Matched placebo, one tablet daily
1198699|NCT00303329|B3|Baseline|Total|Total of all reporting groups
1198700|NCT00303329|B2|Baseline|Rare Anemias Patients|Deferasirox (5-40 mg/kg/day)
1198701|NCT00303329|B1|Baseline|β-thalassemia Patients|Deferasirox (5-40 mg/kg/day)
1198702|NCT00303329|P2|Participant Flow|Rare Anemias Patients|Deferasirox (5-40 mg/kg/day)
1198703|NCT00303329|P1|Participant Flow|β-thalassemia Patients|Deferasirox (5-40 mg/kg/day)
1198704|NCT00303329|O2|Outcome|Rare Anemias Patients|Deferasirox (5-40 mg/kg/day)
1198705|NCT00303329|O1|Outcome|β-thalassemia Patients|Deferasirox (5-40 mg/kg/day)
1198706|NCT00303329|O2|Outcome|Rare Anemias Patients|Deferasirox (5-40 mg/kg/day)
1198707|NCT00303329|O1|Outcome|β-thalassemia Patients|Deferasirox (5-40 mg/kg/day)
1198708|NCT00303329|O2|Outcome|Rare Anemias Patients|Deferasirox (5-40 mg/kg/day)
1198709|NCT00303329|O1|Outcome|β-thalassemia Patients|Deferasirox (5-40 mg/kg/day)
1198710|NCT00303329|O2|Outcome|Rare Anemias Patients|Deferasirox (5-40 mg/kg/day)
1198711|NCT00303329|O1|Outcome|β-thalassemia Patients|Deferasirox (5-40 mg/kg/day)
1198712|NCT00303329|E2|Reported Event|Rare Anemias|Deferasirox (5-40 mg/kg/day)
1198713|NCT00303329|E1|Reported Event|Beta-thalassemia|Deferasirox (5-40 mg/kg/day)
1198714|NCT00303316|B3|Baseline|Total|Total of all reporting groups
1198715|NCT00303316|B2|Baseline|PENTAXIM™ and ENGERIX B® Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
1198716|NCT00303316|B1|Baseline|DTacP-IPV-Hep B-PRP~T Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
1198717|NCT00303316|P2|Participant Flow|PENTAXIM™ and ENGERIX B® Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
1198718|NCT00303316|P1|Participant Flow|DTacP-IPV-Hep B-PRP~T Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
1198719|NCT00303316|O2|Outcome|PENTAXIM™ and ENGERIX B® Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
1198720|NCT00303316|O1|Outcome|DTacP-IPV-Hep B-PRP~T Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
1198721|NCT00303316|O2|Outcome|PENTAXIM™ and ENGERIX B® Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
1198722|NCT00303316|O1|Outcome|DTacP-IPV-Hep B-PRP~T Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
1198723|NCT00303316|O2|Outcome|PENTAXIM™ and ENGERIX B® Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
1198724|NCT00303316|O1|Outcome|DTacP-IPV-Hep B-PRP~T Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
1198725|NCT00303316|O2|Outcome|PENTAXIM™ and ENGERIX B® Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
1198784|NCT00303069|B2|Baseline|V710 30 μg|V710 30 μg single dose at baseline.
1198726|NCT00303316|O1|Outcome|DTacP-IPV-Hep B-PRP~T Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
1198727|NCT00303316|E2|Reported Event|PENTAXIM™ and ENGERIX B® Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
1198748|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
1199218|NCT00301262|O1|Outcome|DB Viagra Week 8|
1198728|NCT00303316|E1|Reported Event|DTacP-IPV-Hep B-PRP~T Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
1198729|NCT00303186|B1|Baseline|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
1198730|NCT00303186|P1|Participant Flow|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
1198731|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
1198732|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
1198733|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
1198734|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
1198735|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
1198736|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
1198737|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
1198738|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
1198739|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
1198740|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
1198741|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
1198742|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
1198743|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
1198744|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
1198745|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
1198785|NCT00303069|B1|Baseline|V710 5 μg|V710 5 μg single dose at baseline.
1198746|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
1198747|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
1199219|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
1198749|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
1198750|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
1198751|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
1198752|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
1198753|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
1198754|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
1198755|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
1198756|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
1198757|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
1198758|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
1198759|NCT00303186|E1|Reported Event|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
1198760|NCT00303108|B4|Baseline|Total|Total of all reporting groups
1198761|NCT00303108|B3|Baseline|D+C+H|Doxil, Carboplatin, and Herceptin
1198762|NCT00303108|B2|Baseline|D+C and Taxane Pretreated|Doxil, Carboplatin and Taxane pretreated
1198763|NCT00303108|B1|Baseline|D+C and Taxane Naive|Doxil, Carboplatin and Taxane naive
1198764|NCT00303108|P3|Participant Flow|D+C+H|Doxil, Carboplatin, and Herceptin
1198765|NCT00303108|P2|Participant Flow|D+C and Taxane Pretreated|Doxil, Carboplatin and Taxane pretreated
1198766|NCT00303108|P1|Participant Flow|D+C and Taxane Naive|Doxil, Carboplatin and Taxane naive
1198767|NCT00303108|O3|Outcome|D+C+H|Doxil, Carboplatin, and Herceptin
1198768|NCT00303108|O2|Outcome|D+C and Taxane Pretreated|Doxil, Carboplatin and Taxane pretreated
1198769|NCT00303108|O1|Outcome|D+C and Taxane Naive|Doxil, Carboplatin and Taxane naive
1198770|NCT00303108|O3|Outcome|D+C+H|Doxil, Carboplatin, and Herceptin
1198771|NCT00303108|O2|Outcome|D+C and Taxane Pretreated|Doxil, Carboplatin and Taxane pretreated
1198772|NCT00303108|O1|Outcome|D+C and Taxane Naive|Doxil, Carboplatin and Taxane naive
1198773|NCT00303108|O3|Outcome|D+C+H|Doxil, Carboplatin, and Herceptin
1198774|NCT00303108|O2|Outcome|D+C and Taxane Pretreated|Doxil, Carboplatin and Taxane pretreated
1198775|NCT00303108|O1|Outcome|D+C and Taxane Naive|Doxil, Carboplatin and Taxane naive
1198776|NCT00303108|O3|Outcome|D+C+H|Doxil, Carboplatin, and Herceptin
1198777|NCT00303108|O2|Outcome|D+C and Taxane Pretreated|Doxil, Carboplatin and Taxane pretreated
1198778|NCT00303108|O1|Outcome|D+C and Taxane Naive|Doxil, Carboplatin and Taxane naive
1198779|NCT00303108|E2|Reported Event|D+C+H|Doxil, Carboplatin, and Herceptin
1198780|NCT00303108|E1|Reported Event|D+C and Taxane Naive or Pretreated|Doxil, Carboplatin and Taxane naive or pretreated.
1198781|NCT00303069|B5|Baseline|Total|Total of all reporting groups
1198782|NCT00303069|B4|Baseline|Placebo|Saline placebo single dose at baseline.
1198783|NCT00303069|B3|Baseline|V710 90 μg|V710 90 μg single dose at baseline.
1198786|NCT00303069|P4|Participant Flow|Placebo|"Panel A (dose-ranging) consisted of 36 subjects divided into 3 sequential enrollment periods (Periods 1, 2, and 3), which evaluated the safety of V710 Staphylococcus aureus vaccine at incremental dosages (5 μg, 30 μg, and 90 μg). Subjects in each period were randomized at a 3:1 ratio to receive a single intramuscular (IM) injection of either V710 (5 μg at Period 1; 30 μg in Period 2; and 90 μg in Period 3).~Following the completion of Panel A and satisfactory interim review of the immunogenicity and safety data, the open-enrollment phase (Panel B) was initiated. Panel B consisted of 88 subjects randomized in a 1:1:1:1 ratio to receive a single IM injection of 1 of the 3 V710 dosages (5 μg, 30 μg, or 90 μg) or saline placebo. Enrollment in Panel B was stratified by age, with half of the subjects 18 to 39 years of age, the other half 40 to 55 years of age."
1198854|NCT00302848|E1|Reported Event|Users of Drospirenone (DRSP)|Women who use oral contraceptives (OCs) containing DRSP as progestin
1198787|NCT00303069|P3|Participant Flow|V710 90 μg|"Panel A (dose-ranging) consisted of 36 subjects divided into 3 sequential enrollment periods (Periods 1, 2, and 3), which evaluated the safety of V710 Staphylococcus aureus vaccine at incremental dosages (5 μg, 30 μg, and 90 μg). Subjects in each period were randomized at a 3:1 ratio to receive a single intramuscular (IM) injection of either V710 (5 μg at Period 1; 30 μg in Period 2; and 90 μg in Period 3).~Following the completion of Panel A and satisfactory interim review of the immunogenicity and safety data, the open-enrollment phase (Panel B) was initiated. Panel B consisted of 88 subjects randomized in a 1:1:1:1 ratio to receive a single IM injection of 1 of the 3 V710 dosages (5 μg, 30 μg, or 90 μg) or saline placebo. Enrollment in Panel B was stratified by age, with half of the subjects 18 to 39 years of age, the other half 40 to 55 years of age."
1198788|NCT00303069|P2|Participant Flow|V710 30 μg|"Panel A (dose-ranging) consisted of 36 subjects divided into 3 sequential enrollment periods (Periods 1, 2, and 3), which evaluated the safety of V710 Staphylococcus aureus vaccine at incremental dosages (5 μg, 30 μg, and 90 μg). Subjects in each period were randomized at a 3:1 ratio to receive a single intramuscular (IM) injection of either V710 (5 μg at Period 1; 30 μg in Period 2; and 90 μg in Period 3).~Following the completion of Panel A and satisfactory interim review of the immunogenicity and safety data, the open-enrollment phase (Panel B) was initiated. Panel B consisted of 88 subjects randomized in a 1:1:1:1 ratio to receive a single IM injection of 1 of the 3 V710 dosages (5 μg, 30 μg, or 90 μg) or saline placebo. Enrollment in Panel B was stratified by age, with half of the subjects 18 to 39 years of age, the other half 40 to 55 years of age."
1198789|NCT00303069|P1|Participant Flow|V710 5 μg|"Panel A (dose-ranging) consisted of 36 subjects divided into 3 sequential enrollment periods (Periods 1, 2, and 3), which evaluated the safety of V710 Staphylococcus aureus vaccine at incremental dosages (5 μg, 30 μg, and 90 μg). Subjects in each period were randomized at a 3:1 ratio to receive a single intramuscular (IM) injection of either V710 (5 μg at Period 1; 30 μg in Period 2; and 90 μg in Period 3).~Following the completion of Panel A and satisfactory interim review of the immunogenicity and safety data, the open-enrollment phase (Panel B) was initiated. Panel B consisted of 88 subjects randomized in a 1:1:1:1 ratio to receive a single IM injection of 1 of the 3 V710 dosages (5 μg, 30 μg, or 90 μg) or saline placebo. Enrollment in Panel B was stratified by age, with half of the subjects 18 to 39 years of age, the other half 40 to 55 years of age."
1198790|NCT00303069|O4|Outcome|Placebo|Saline placebo single dose at baseline.
1198791|NCT00303069|O3|Outcome|V710 90 μg|V710 90 μg single dose at baseline.
1198792|NCT00303069|O2|Outcome|V710 30 μg|V710 30 μg single dose at baseline.
1198793|NCT00303069|O1|Outcome|V710 5 μg|V710 5 μg single dose at baseline.
1198794|NCT00303069|O4|Outcome|Placebo|Saline placebo single dose at baseline.
1198795|NCT00303069|O3|Outcome|V710 90 μg|V710 90 μg single dose at baseline.
1198796|NCT00303069|O2|Outcome|V710 30 μg|V710 30 μg single dose at baseline.
1198797|NCT00303069|O1|Outcome|V710 5 μg|V710 5 μg single dose at baseline.
1198798|NCT00303069|O4|Outcome|Placebo|Saline placebo single dose at baseline.
1198799|NCT00303069|O3|Outcome|V710 90 μg|V710 90 μg single dose at baseline.
1198800|NCT00303069|O2|Outcome|V710 30 μg|V710 30 μg single dose at baseline.
1198801|NCT00303069|O1|Outcome|V710 5 μg|V710 5 μg single dose at baseline.
1198802|NCT00303069|E4|Reported Event|Placebo|Saline placebo single dose at baseline.
1198803|NCT00303069|E3|Reported Event|V710 90 μg|V710 90 μg single dose at baseline.
1198804|NCT00303069|E2|Reported Event|V710 30 μg|V710 30 μg single dose at baseline.
1198805|NCT00303069|E1|Reported Event|V710 5 μg|V710 5 μg single dose at baseline.
1198806|NCT00302952|B3|Baseline|Total|Total of all reporting groups
1198807|NCT00302952|B2|Baseline|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
1198808|NCT00302952|B1|Baseline|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
1198809|NCT00302952|P2|Participant Flow|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
1198810|NCT00302952|P1|Participant Flow|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
1198811|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
1198812|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
1198813|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
1198814|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
1198815|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
1198816|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
1198817|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
1198818|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
1198819|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
1198820|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
1198821|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
1198822|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
1198823|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
1198824|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
1198825|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
1198826|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
1198827|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
1198847|NCT00302848|P3|Participant Flow|Users of Other Oral Contraceptives (OCs)|Women who use oral contraceptives (OCs) containing other progestins
1199122|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
1198828|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
1198829|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
1198830|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
1198831|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
1198832|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
1198833|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
1198834|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
1198835|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
1198836|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
1198837|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
1198838|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
1198839|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
1198840|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
1198841|NCT00302952|E2|Reported Event|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
1198842|NCT00302952|E1|Reported Event|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
1198843|NCT00302848|B4|Baseline|Total|Total of all reporting groups
1198844|NCT00302848|B3|Baseline|Users of Other Oral Contraceptives (OCs)|Women who use oral contraceptives (OCs) containing other progestins
1198845|NCT00302848|B2|Baseline|Users of Levonorgestrel (LNG)|Women who use oral contraceptives (OCs) containing LNG as progestin
1198846|NCT00302848|B1|Baseline|Users of Drospirenone (DRSP)|Women who use oral contraceptives (OCs) containing DRSP as progestin
1199123|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
1198848|NCT00302848|P2|Participant Flow|Users of Levonorgestrel (LNG)|Women who use oral contraceptives (OCs) containing LNG as progestin
1198849|NCT00302848|P1|Participant Flow|Users of Drospirenone (DRSP)|Women who use oral contraceptives (OCs) containing DRSP as progestin
1198850|NCT00302848|O2|Outcome|Users of LNG|Women who use authorized oral contraceptives containing LNG prescribed by their gynecologist
1198851|NCT00302848|O1|Outcome|Users of DRSP|Women who use authorized oral contraceptives containing DRSP prescribed by their gynecologist
1198852|NCT00302848|E3|Reported Event|Users of Other Oral Contraceptives (OCs)|Women who use oral contraceptives (OCs) containing other progestins
1198853|NCT00302848|E2|Reported Event|Users of Levonorgestrel (LNG)|Women who use oral contraceptives (OCs) containing LNG as progestin
1198856|NCT00302718|B4|Baseline|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
1198857|NCT00302718|B3|Baseline|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care~Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
1198858|NCT00302718|B2|Baseline|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care~Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
1198859|NCT00302718|B1|Baseline|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care~Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
1198860|NCT00302718|P4|Participant Flow|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
1198861|NCT00302718|P3|Participant Flow|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care~Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
1198862|NCT00302718|P2|Participant Flow|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care~Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
1198863|NCT00302718|P1|Participant Flow|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care~Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
1198864|NCT00302718|O2|Outcome|Intervention Group|This group is a combination of the physician and non-physician participants and the patients on the panels of the physician participants from the three intervention arms: physician-level, practice-level, and physician- and practice-level financial incentives.
1198865|NCT00302718|O1|Outcome|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
1198866|NCT00302718|O4|Outcome|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
1198867|NCT00302718|O3|Outcome|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care~Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
1198868|NCT00302718|O2|Outcome|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care~Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
1198869|NCT00302718|O1|Outcome|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care~Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
1198870|NCT00302718|O4|Outcome|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
1198871|NCT00302718|O3|Outcome|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care~Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
1198872|NCT00302718|O2|Outcome|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care~Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
1199124|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
1198873|NCT00302718|O1|Outcome|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care~Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
1198874|NCT00302718|O4|Outcome|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
1198875|NCT00302718|O3|Outcome|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care~Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
1199220|NCT00301262|O3|Outcome|DB Placebo Week 8|
1198876|NCT00302718|O2|Outcome|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care~Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
1198877|NCT00302718|O1|Outcome|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care~Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
1198878|NCT00302718|O4|Outcome|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
1198879|NCT00302718|O3|Outcome|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care~Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
1198880|NCT00302718|O2|Outcome|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care~Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
1198881|NCT00302718|O1|Outcome|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care~Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
1198882|NCT00302718|O4|Outcome|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
1198883|NCT00302718|O3|Outcome|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care~Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
1198884|NCT00302718|O2|Outcome|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care~Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
1198885|NCT00302718|O1|Outcome|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care~Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
1198886|NCT00302718|O4|Outcome|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
1198887|NCT00302718|O3|Outcome|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care~Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
1198888|NCT00302718|O2|Outcome|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care~Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
1198889|NCT00302718|O1|Outcome|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care~Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
1198890|NCT00302718|E4|Reported Event|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
1198891|NCT00302718|E3|Reported Event|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care~Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
1198892|NCT00302718|E2|Reported Event|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care~Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
1198893|NCT00302718|E1|Reported Event|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care~Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
1198894|NCT00302458|B1|Baseline|Healthy Volunteers|Healthy volunteers each received IR-MPH, OROS-MPH, and matched placebo (in four separate visits) in a four way crossover design.
1198895|NCT00302458|P1|Participant Flow|Healthy Volunteers|Healthy volunteers each received IR MPH, Oros MPH, and matched placebo (at four separate study visits) in a four way crossover design.
1198896|NCT00302458|O5|Outcome|OROS-MPH+ IR-MPH|Healthy volunteers received a dose of OROS-Methylphenidate at hour 0, followed by a dose of Immediate Release Methylphenidate four hours later
1199221|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
1198897|NCT00302458|O4|Outcome|OROS-MPH+OROS-MPH|Healthy volunteers received a dose of OROS-Methylphenidate at hour 0, followed by a dose of OROS-Methylphenidate four hours later
1198898|NCT00302458|O3|Outcome|IR-MPH +IR-MPH|Healthy volunteers received a dose of Immediatate Release Methylphenidate at hour 0, followed by a dose of Immediate Release Methylphenidate four hours later
1198899|NCT00302458|O2|Outcome|IR-MPH + OROS MPH|Healthy volunteers received a dose of Immediatate Release Methylphenidate at hour 0, followed by a dose of OROS-Methylphenidate four hours later
1198900|NCT00302458|O1|Outcome|Placebo- Placebo|Healthy volunteers received a placebo, followed by a placebo four hours later
1198901|NCT00302458|E1|Reported Event|Healthy Volunteers|Healthy volunteers each received IR MPH, Oros MPH, and matched placebo (at four separate study visits) in a four way crossover design.
1198902|NCT00302328|B4|Baseline|Total|Total of all reporting groups
1198903|NCT00302328|B3|Baseline|tb Peeling|trypan blue (tb) peeling
1198904|NCT00302328|B2|Baseline|ICG Peeling|indocyanine green (ICG) peeling
1198905|NCT00302328|B1|Baseline|no Peeling|no peeling used
1198906|NCT00302328|P3|Participant Flow|tb Peeling|trypan blue (tb) peeling
1198907|NCT00302328|P2|Participant Flow|ICG Peeling|indocyanine (ICG) peeling
1198908|NCT00302328|P1|Participant Flow|no Peeling|no peeling used
1198909|NCT00302328|O3|Outcome|tb Peeling|vitrectomy with trypan blue assisted ilm peeling
1198910|NCT00302328|O2|Outcome|ICG Peeling|vitrectomy with icg assited ilm peeling
1198911|NCT00302328|O1|Outcome|no Peeling|vitrectomy without ilm peeling
1198912|NCT00302328|O3|Outcome|tb Peeling|vitrectomy with trypan blue assited ilm peeling
1198913|NCT00302328|O2|Outcome|ICG Peeling|vitrectomy with icg assited ilm peeling
1198914|NCT00302328|O1|Outcome|no Peeling|vitrectomy without ilm peeling
1198915|NCT00302328|O3|Outcome|tb Peeling|vitrectomy with trypan blue assisted ilm peeling
1198916|NCT00302328|O2|Outcome|ICG Peeling|vitrectomy with icg-assisted ilm peeling
1198917|NCT00302328|O1|Outcome|no Peeling|Vitrectomy without peeling
1198918|NCT00302328|E3|Reported Event|tb Peeling|vitrectomy with trypan blue assited ilm peeling
1198919|NCT00302328|E2|Reported Event|ICG Peeling|vitrectomy with icg assited ilm peeling
1198920|NCT00302328|E1|Reported Event|no Peeling|vitrectomy without ilm peeling
1198921|NCT00302211|B4|Baseline|Total|Total of all reporting groups
1198922|NCT00302211|B3|Baseline|Placebo 6×/Day + Sildenafil +/- Bosentan|Blinded Inhaled placebo 6×/day plus sildenafil with or without bosentan
1198923|NCT00302211|B2|Baseline|Iloprost 4×/Day + Placebo 2x/Day + Sildenafil ± Bosentan|Blinded Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan
1198924|NCT00302211|B1|Baseline|Iloprost(5 μg) 6×/Day Plus Sildenafil +/- Bosentan|Blinded Inhaled iloprost(5 μg) 6×/day plus sildenafil with or without bosentan
1198925|NCT00302211|P5|Participant Flow|OL Inhaled Iloprost (5μg) (4x/Day) & Sildenafil ± Bosentan|Open-Label(OL) inhaled iloprost (5μg)plus sildenafil with or without bosentan
1198926|NCT00302211|P4|Participant Flow|OL Iloprost (5μg) 6x/Day Plus Sildenafil With/Without Bosentan|Open-Label(OL) inhaled iloprost (5μg)plus sildenafil with or without bosentan
1198927|NCT00302211|P3|Participant Flow|Placebo 6×/Day Plus Sildenafil With or Without Bosentan|Blinded Inhaled placebo 6×/day plus sildenafil with or without bosentan
1198928|NCT00302211|P2|Participant Flow|Iloprost 4×/Day and Placebo 2x/Day With Sildenafil ± Bosentan|Blinded Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day with sildenafil with or without bosentan
1198929|NCT00302211|P1|Participant Flow|Iloprost(5 μg) 6×/Day Plus Sildenafil With or Without Bosentan|Blinded Inhaled iloprost(5 μg) 6×/day plus sildenafil with or without bosentan
1198930|NCT00302211|O5|Outcome|OL Inhaled Iloprost (5μg) (4x/Day) & Sildenafil ± Bosentan|Open-Label(OL) inhaled iloprost (5μg)plus sildenafil with or without bosentan
1198931|NCT00302211|O4|Outcome|OL Iloprost (5μg) 6x/Day Plus Sildenafil With/Without Bosentan|Open-Label(OL) inhaled iloprost (5μg)plus sildenafil with or without bosentan
1198932|NCT00302211|O3|Outcome|Placebo 6×/Day Plus Sildenafil With or Without Bosentan|Blinded Inhaled placebo 6×/day plus sildenafil with or without bosentan
1198933|NCT00302211|O2|Outcome|Iloprost 4×/Day and Placebo 2x/Day With Sildenafil ± Bosentan|Blinded Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day with sildenafil with or without bosentan
1198934|NCT00302211|O1|Outcome|Iloprost(5 μg) 6×/Day Plus Sildenafil With or Without Bosentan|Blinded Inhaled iloprost(5 μg) 6×/day plus sildenafil with or without bosentan
1198935|NCT00302211|E5|Reported Event|OL Inhaled Iloprost (5μg) (4x/Day) & Sildenafil ± Bosentan|Open-Label(OL) inhaled iloprost (5μg)plus sildenafil with or without bosentan
1198936|NCT00302211|E4|Reported Event|OL Iloprost (5μg) 6x/Day Plus Sildenafil With/Without Bosentan|Open-Label(OL) inhaled iloprost (5μg)plus sildenafil with or without bosentan
1198937|NCT00302211|E3|Reported Event|Placebo 6×/Day Plus Sildenafil With or Without Bosentan|Blinded Inhaled placebo 6×/day plus sildenafil with or without bosentan
1198938|NCT00302211|E2|Reported Event|Iloprost 4×/Day and Placebo 2x/Day With Sildenafil ± Bosentan|Blinded Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day with sildenafil with or without bosentan
1198939|NCT00302211|E1|Reported Event|Iloprost(5 μg) 6×/Day Plus Sildenafil With or Without Bosentan|Blinded Inhaled iloprost(5 μg) 6×/day plus sildenafil with or without bosentan
1198976|NCT00302081|O3|Outcome|PEG2b 1.5/R (16 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 16 weeks
1198940|NCT00302159|B1|Baseline|Valproic Acid|"adjuvant therapy~Temozolomide Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.~Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
1198941|NCT00302159|P1|Participant Flow|Valproic Acid|"adjuvant therapy~Temozolomide Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.~Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
1199028|NCT00302042|O1|Outcome|Experimental: 1: Brief Counseling Plus Group Lifestyle|Brief counseling for pre-diabetes plus access to a group-based diabetes prevention lifestyle intervention in the community
1198942|NCT00302159|O1|Outcome|Valproic Acid|"Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~adjuvant therapy~Temozolomide: Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.~Valproic Acid: Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~Radiation therapy: External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
1198943|NCT00302159|O1|Outcome|Valproic Acid|"Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~adjuvant therapy~Temozolomide: Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.~Valproic Acid: Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~Radiation therapy: External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
1198944|NCT00302159|O1|Outcome|Valproic Acid|"Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~adjuvant therapy~Temozolomide: Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.~Valproic Acid: Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~Radiation therapy: External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
1198945|NCT00302159|O1|Outcome|Valproic Acid|"Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~adjuvant therapy~Temozolomide: Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.~Valproic Acid: Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~Radiation therapy: External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
1198946|NCT00302159|O1|Outcome|Valproic Acid|"adjuvant therapy~Temozolomide Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.~Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
1198947|NCT00302159|O1|Outcome|Valproic Acid|"adjuvant therapy~Temozolomide Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.~Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
1198948|NCT00302159|E1|Reported Event|Valproic Acid|"adjuvant therapy~Temozolomide Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.~Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
1198949|NCT00302133|B3|Baseline|Total|Total of all reporting groups
1198950|NCT00302133|B2|Baseline|Placebo|"Placebo add on to valproate open label~Placebo add on to open label valproate for 12 weeks"
1198951|NCT00302133|B1|Baseline|Naltrexone|"Naltrexone add on to valproate open label~naltrexone add on to open label valproate: naltrexone 50 mg/day for 12 weeks add on to open label valproate"
1198952|NCT00302133|P2|Participant Flow|Placebo|"Placebo add on to valproate open label~Placebo one capsule daily for 12 weeks"
1198953|NCT00302133|P1|Participant Flow|Naltrexone|"Naltrexone add on to valproate open label~Naltrexone Hydrochloride 50 mg daily for 12 weeks"
1198954|NCT00302133|O2|Outcome|Placebo|"Placebo add on to valproate open label~Placebo add on to open label valproate for 12 weeks"
1198955|NCT00302133|O1|Outcome|Naltrexone|"Naltrexone add on to valproate open label~naltrexone add on to open label valproate: naltrexone 50 mg/day for 12 weeks add on to open label valproate"
1198956|NCT00302133|O2|Outcome|Placebo|"Placebo add on to valproate open label~Placebo add on to open label valproate for 12 weeks"
1198957|NCT00302133|O1|Outcome|Naltrexone|"Naltrexone add on to valproate open label~naltrexone add on to open label valproate: naltrexone 50 mg/day for 12 weeks add on to open label valproate"
1198958|NCT00302133|E2|Reported Event|Placebo|"Placebo add on to valproate open label~Placebo add on to open label valproate for 12 weeks"
1198959|NCT00302133|E1|Reported Event|Naltrexone|"Naltrexone add on to valproate open label~naltrexone add on to open label valproate: naltrexone 50 mg/day for 12 weeks add on to open label valproate"
1198960|NCT00302107|B3|Baseline|Total|Total of all reporting groups
1198961|NCT00302107|B2|Baseline|Placebo|Placebo up to three tablets qhs
1198962|NCT00302107|B1|Baseline|Mirtazapine|Mirtazapine up to 45 mg/qhs as tolerated
1198963|NCT00302107|P2|Participant Flow|Placebo|Placebo up to three pills qhs
1198964|NCT00302107|P1|Participant Flow|Mirtazapine|Mirtazapine up to 45mg/qhs (three 15mg pills) as tolerated.
1198965|NCT00302107|O2|Outcome|Placebo|Placebo up to 3 tablets qhs
1198966|NCT00302107|O1|Outcome|Mirtazapine|Mirtazapine up to 45mg/qhs as tolerated
1198967|NCT00302107|E2|Reported Event|Placebo|Placebo up to 3 tablets qhs
1198968|NCT00302107|E1|Reported Event|Mirtazapine|Mirtazapine up to 45mg/qhs as tolerated
1198969|NCT00302081|B4|Baseline|Total|Total of all reporting groups
1198970|NCT00302081|B3|Baseline|PEG2b 1.5/R (16 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 16 weeks
1198971|NCT00302081|B2|Baseline|PEG2b 1.0/R (24 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 24 weeks
1198972|NCT00302081|B1|Baseline|PEG2b 1.5/R (24 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg daily for 24 weeks
1198973|NCT00302081|P3|Participant Flow|PEG2b 1.5/R (16 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 16 weeks
1198974|NCT00302081|P2|Participant Flow|PEG2b 1.0/R (24 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 24 weeks
1198975|NCT00302081|P1|Participant Flow|PEG2b 1.5/R (24 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg daily for 24 weeks
1198977|NCT00302081|O2|Outcome|PEG2b 1.0/R (24 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 24 weeks
1198978|NCT00302081|O1|Outcome|PEG2b 1.5/R (24 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg daily for 24 weeks
1198979|NCT00302081|E3|Reported Event|PEG2b 1.5/R*(16 Weeks)|
1198980|NCT00302081|E2|Reported Event|PEG2b 1.0/R*(24 Weeks)|
1198981|NCT00302081|E1|Reported Event|PEG2b 1.5/R*(24 Weeks)|
1198982|NCT00302068|B4|Baseline|Total|Total of all reporting groups
1198983|NCT00302068|B3|Baseline|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
1198984|NCT00302068|B2|Baseline|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
1198985|NCT00302068|B1|Baseline|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
1198986|NCT00302068|P3|Participant Flow|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
1198987|NCT00302068|P2|Participant Flow|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
1198988|NCT00302068|P1|Participant Flow|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
1198989|NCT00302068|O3|Outcome|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
1198990|NCT00302068|O2|Outcome|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
1198991|NCT00302068|O1|Outcome|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
1198992|NCT00302068|O3|Outcome|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
1198993|NCT00302068|O2|Outcome|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
1198994|NCT00302068|O1|Outcome|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
1198995|NCT00302068|O3|Outcome|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
1198996|NCT00302068|O2|Outcome|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
1198997|NCT00302068|O1|Outcome|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
1198998|NCT00302068|O3|Outcome|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
1198999|NCT00302068|O2|Outcome|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
1199125|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
1199000|NCT00302068|O1|Outcome|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
1199029|NCT00302042|E2|Reported Event|Active Comparator: 2: Brief Counseling Alone|Brief Counseling for pre-diabetes alone without access to group lifestyle
1199222|NCT00301262|O1|Outcome|DB Viagra Week 8|
1199001|NCT00302068|O3|Outcome|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
1199002|NCT00302068|O2|Outcome|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
1199003|NCT00302068|O1|Outcome|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
1199004|NCT00302068|O3|Outcome|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects..
1199005|NCT00302068|O2|Outcome|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
1199006|NCT00302068|O1|Outcome|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
1199007|NCT00302068|O3|Outcome|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
1199008|NCT00302068|O2|Outcome|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
1199009|NCT00302068|O1|Outcome|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
1199010|NCT00302068|E3|Reported Event|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
1199011|NCT00302068|E2|Reported Event|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
1199012|NCT00302068|E1|Reported Event|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
1199013|NCT00302055|B3|Baseline|Total|Total of all reporting groups
1199014|NCT00302055|B2|Baseline|Group-based Community Lifestyle|Clinical referral to group diabetes prevention lifestyle intervention program in community
1199015|NCT00302055|B1|Baseline|One-on-one Lifestyle|Clinical referral for diabetes prevention lifestyle intervention at School of Medicine campus
1199016|NCT00302055|P2|Participant Flow|Group-based Community Lifestyle|Clinical referral to group diabetes prevention lifestyle intervention program in community
1199017|NCT00302055|P1|Participant Flow|One-on-one Lifestyle|Clinical referral for diabetes prevention lifestyle intervention at School of Medicine campus
1199018|NCT00302055|O2|Outcome|Group-based Community Lifestyle|Clinical referral to group diabetes prevention lifestyle intervention program in community
1199019|NCT00302055|O1|Outcome|One-on-one Lifestyle|Clinical referral for diabetes prevention lifestyle intervention at School of Medicine campus
1199020|NCT00302055|E2|Reported Event|Group-based Community Lifestyle|Clinical referral to group diabetes prevention lifestyle intervention program in community
1199021|NCT00302055|E1|Reported Event|One-on-one Lifestyle|Clinical referral for diabetes prevention lifestyle intervention at School of Medicine campus
1199022|NCT00302042|B3|Baseline|Total|Total of all reporting groups
1199023|NCT00302042|B2|Baseline|Active Comparator: 2: Brief Counseling Alone|Brief Counseling for pre-diabetes alone without access to group lifestyle
1199024|NCT00302042|B1|Baseline|Experimental: 1: Brief Counseling Plus Group Lifestyle|Brief counseling for pre-diabetes plus access to a group-based diabetes prevention lifestyle intervention in the community
1199025|NCT00302042|P2|Participant Flow|Active Comparator: 2: Brief Counseling Alone|Brief Counseling for pre-diabetes alone without access to group lifestyle
1199051|NCT00301834|O1|Outcome|Single Arm - Transplant Pre-conditioning Per Study Protocol|Conditioning with Alemtuzumab, busulfan and fludarabine followed by allogeneic hematopoietic cell transplant.
1199026|NCT00302042|P1|Participant Flow|Experimental: 1: Brief Counseling Plus Group Lifestyle|Brief counseling for pre-diabetes plus access to a group-based diabetes prevention lifestyle intervention in the community
1199027|NCT00302042|O2|Outcome|Active Comparator: 2: Brief Counseling Alone|Brief Counseling for pre-diabetes alone without access to group lifestyle
1199030|NCT00302042|E1|Reported Event|Experimental: 1: Brief Counseling Plus Group Lifestyle|Brief counseling for pre-diabetes plus access to a group-based diabetes prevention lifestyle intervention in the community
1199031|NCT00302003|B1|Baseline|Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim|"Treatment consists of 3 cycles of Doxorubicin hydrochloride IV (25 mg/m2) days 1 & 2, Vincristine sulfate IV (1.4 mg/m2 [max 2.8 mg]) Days 1 & 8, Prednisone orally (40 mg/m2) Days 1-7, Cyclophosphamide IV (600 mg/m2) Days 1 & 2, Filgrastim by mouth or IV (5 micrograms/kg/dose) 24 hours after Cyclophosphamide complete. See detailed description for remainder of therapy.~radiation therapy: Undergo radiation therapy~doxorubicin hydrochloride: Given IV~vincristine sulfate: Given IV~prednisone: Given orally~cyclophosphamide: Given IV~ifosfamide: Given IV~vinorelbine tartrate: Given IV~dexamethasone: Given IV~etoposide phosphate: Given IV~cisplatin: Given IV~cytarabine: Given IV~filgrastim: Given IV or subcutaneously"
1199032|NCT00302003|P1|Participant Flow|Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim|"Treatment consists of 3 cycles of Doxorubicin hydrochloride IV (25 mg/m2) days 1 & 2, Vincristine sulfate IV (1.4 mg/m2 [max 2.8 mg]) Days 1 & 8, Prednisone orally (40 mg/m2) Days 1-7, Cyclophosphamide IV (600 mg/m2) Days 1 & 2, Filgrastim by mouth or IV (5 micrograms/kg/dose) 24 hours after Cyclophosphamide complete. See detailed description for remainder of therapy.~radiation therapy: Undergo radiation therapy~doxorubicin hydrochloride: Given IV~vincristine sulfate: Given IV~prednisone: Given orally~cyclophosphamide: Given IV~ifosfamide: Given IV~vinorelbine tartrate: Given IV~dexamethasone: Given IV~etoposide phosphate: Given IV~cisplatin: Given IV~cytarabine: Given IV~filgrastim: Given IV or subcutaneously"
1199033|NCT00302003|O1|Outcome|Group 1|Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
1199034|NCT00302003|O1|Outcome|Group 1|Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
1199035|NCT00302003|O1|Outcome|Group 1|Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
1199036|NCT00302003|O1|Outcome|Group 1|Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
1199037|NCT00302003|E1|Reported Event|Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim|"Treatment consists of 3 cycles of Doxorubicin hydrochloride IV (25 mg/m2) days 1 & 2, Vincristine sulfate IV (1.4 mg/m2 [max 2.8 mg]) Days 1 & 8, Prednisone orally (40 mg/m2) Days 1-7, Cyclophosphamide IV (600 mg/m2) Days 1 & 2, Filgrastim by mouth or IV (5 micrograms/kg/dose) 24 hours after Cyclophosphamide complete. See detailed description for remainder of therapy.~radiation therapy: Undergo radiation therapy~doxorubicin hydrochloride: Given IV~vincristine sulfate: Given IV~prednisone: Given orally~cyclophosphamide: Given IV~ifosfamide: Given IV~vinorelbine tartrate: Given IV~dexamethasone: Given IV~etoposide phosphate: Given IV~cisplatin: Given IV~cytarabine: Given IV~filgrastim: Given IV or subcutaneously"
1199038|NCT00301964|B1|Baseline|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
1199039|NCT00301964|P1|Participant Flow|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
1199040|NCT00301964|O1|Outcome|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
1199041|NCT00301964|O1|Outcome|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
1199042|NCT00301964|E1|Reported Event|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
1199043|NCT00301873|B1|Baseline|IV Zometa|Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
1199044|NCT00301873|P1|Participant Flow|IV Zometa|Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
1199045|NCT00301873|O1|Outcome|IV Zometa|Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
1199046|NCT00301873|O1|Outcome|IV Zometa|Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
1199047|NCT00301873|O1|Outcome|IV Zometa|Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
1199048|NCT00301873|E1|Reported Event|IV Zometa|Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
1199049|NCT00301834|B1|Baseline|Single Arm - Transplant Pre-conditioning Per Study Protocol|All eligible patients received pre-transplant conditioning with Alemtuzumab, fludarabine and targeted busulfan followed by allogeneic transplant. The initial dose of busulfan was determined by performing PK (pharmacokinetics) analysis on a test dose of busulfan on the day prior to initiating conditioning. Based on the PK results a starting dose of busulfan was determined. A second PK study was done after the starting dose to ensure that the targeted dose was achieved. If it wasn't achieved, then a dose modification was made and a third PK study done.
1199050|NCT00301834|P1|Participant Flow|Single Arm - Transplant Pre-conditioning Per Study Protocol|All eligible patients received pre-transplant conditioning with Alemtuzumab, fludarabine and targeted busulfan followed by allogeneic transplant. The initial dose of busulfan was determined by performing PK (pharmacokinetics) analysis on a test dose of busulfan on the day prior to initiating conditioning. Based on the PK results a starting dose of busulfan was determined. A second PK study was done after the starting dose to ensure that the targeted dose was achieved. If it wasn't achieved, then a dose modification was made and a third PK study done.
1199111|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
1199052|NCT00301834|O2|Outcome|CMV Seropositive Participants|"seropositivity means the presence of anti-CMV IgG, indicating past infection by the virus"
1199053|NCT00301834|O1|Outcome|CMV Seronegative Participants|"seronegativity means no detected presence of anti-CMV IgG, indicating no past infection by the virus"
1199054|NCT00301834|O1|Outcome|Single Arm|Conditioning with Alemtuzumab, busulfan and fludarabine followed by allogeneic hematopoietic cell transplant.
1199055|NCT00301834|O1|Outcome|Single Arm - Transplant Pre-conditioning Per Study Protocol|Conditioning with Alemtuzumab, busulfan and fludarabine followed by allogeneic hematopoietic cell transplant.
1199133|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
1199056|NCT00301834|O1|Outcome|Single Arm - Transplant Pre-conditioning Per Study Protocol|Conditioning with Alemtuzumab, busulfan and fludarabine followed by allogeneic hematopoietic cell transplant.
1199057|NCT00301834|E1|Reported Event|Single Arm - Transplant Pre-conditioning Per Study Protocol|All eligible patients received pre-transplant conditioning with Alemtuzumab, fludarabine and targeted busulfan followed by allogeneic transplant. The initial dose of busulfan was determined by performing PK (pharmacokinetics) analysis on a test dose of busulfan on the day prior to initiating conditioning. Based on the PK results a starting dose of busulfan was determined. A second PK study was done after the starting dose to ensure that the targeted dose was achieved. If it wasn't achieved, then a dose modification was made and a third PK study done.
1199058|NCT00301821|B1|Baseline|Epratuzumab + Rituximab + CHOP|One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
1199059|NCT00301821|P1|Participant Flow|Epratuzumab + Rituximab + CHOP|One arm open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate
1199060|NCT00301821|O1|Outcome|Epratuzumab + Rituximab + CHOP|One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
1199061|NCT00301821|O1|Outcome|Epratuzumab + Rituximab + CHOP|One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
1199062|NCT00301821|O1|Outcome|Epratuzumab + Rituximab + CHOP|One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
1199063|NCT00301821|O1|Outcome|Epratuzumab + Rituximab + CHOP|One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
1199064|NCT00301821|E1|Reported Event|Epratuzumab + Rituximab + CHOP|One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
1199065|NCT00301808|B1|Baseline|Cisplatin, Docetaxel & Radiation Therapy|"Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.~Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43~Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle~Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43~Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy."
1199066|NCT00301808|P1|Participant Flow|Cisplatin, Docetaxel & Radiation Therapy|"Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.~Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43~Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle~Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43~Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy."
1199067|NCT00301808|O1|Outcome|Cisplatin, Docetaxel & Radiation Therapy|"Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.~Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43~Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle~Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43~Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy."
1199068|NCT00301808|E1|Reported Event|Cisplatin, Docetaxel & Radiation Therapy|"Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.~Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43~Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle~Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43~Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy."
1199069|NCT00301756|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1199070|NCT00301756|P1|Participant Flow|Treatment (Belinostat / Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1199071|NCT00301756|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV"
1199072|NCT00301756|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV"
1199073|NCT00301756|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV"
1199074|NCT00301756|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV"
1199075|NCT00301756|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV"
1199076|NCT00301756|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1199077|NCT00301756|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1199112|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
1199113|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
1199078|NCT00301418|B1|Baseline|Tarceva (Erlotinib)|Erlotinib: Tarceva®: Will be given at a starting dose of 150mg QD dose for the first cycle which is 28 days. This will be followed by 14 days of 100mg PO on a bid schedule and 150mg PO on a bid schedule for the final 14 days of the second cycle. Assuming no dose limiting toxicity, 150 mg PO tid will be continued for up to 10 more cycles. This is an outpatient regimen, in which the drug is admininistered orally. Tumor response will be assessed after every 2nd treatment cycle. Patients may receive a maximum of 12 cycles of treatment under this research protocol.
1199134|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
1199079|NCT00301418|P1|Participant Flow|Tarceva (Erlotinib)|Erlotinib: Tarceva®: Will be given at a starting dose of 150mg QD dose for the first cycle which is 28 days. This will be followed by 14 days of 100mg PO on a bid schedule and 150mg PO on a bid schedule for the final 14 days of the second cycle. Assuming no dose limiting toxicity, 150 mg PO tid will be continued for up to 10 more cycles. This is an outpatient regimen, in which the drug is admininistered orally. Tumor response will be assessed after every 2nd treatment cycle. Patients may receive a maximum of 12 cycles of treatment under this research protocol.
1199080|NCT00301418|O1|Outcome|Tarceva (Erlotinib)|Erlotinib: Tarceva®: Will be given at a starting dose of 150mg QD dose for the first cycle which is 28 days. This will be followed by 14 days of 100mg PO on a bid schedule and 150mg PO on a bid schedule for the final 14 days of the second cycle. Assuming no dose limiting toxicity, 150 mg PO tid will be continued for up to 10 more cycles. This is an outpatient regimen, in which the drug is admininistered orally. Tumor response will be assessed after every 2nd treatment cycle. Patients may receive a maximum of 12 cycles of treatment under this research protocol.
1199081|NCT00301418|O1|Outcome|Tarceva (Erlotinib)|Erlotinib: Tarceva®: Will be given at a starting dose of 150mg QD dose for the first cycle which is 28 days. This will be followed by 14 days of 100mg PO on a bid schedule and 150mg PO on a bid schedule for the final 14 days of the second cycle. Assuming no dose limiting toxicity, 150 mg PO tid will be continued for up to 10 more cycles. This is an outpatient regimen, in which the drug is admininistered orally. Tumor response will be assessed after every 2nd treatment cycle. Patients may receive a maximum of 12 cycles of treatment under this research protocol.
1199082|NCT00301418|O1|Outcome|Tarceva (Erlotinib)|Erlotinib: Tarceva®: Will be given at a starting dose of 150mg QD dose for the first cycle which is 28 days. This will be followed by 14 days of 100mg PO on a bid schedule and 150mg PO on a bid schedule for the final 14 days of the second cycle. Assuming no dose limiting toxicity, 150 mg PO tid will be continued for up to 10 more cycles. This is an outpatient regimen, in which the drug is admininistered orally. Tumor response will be assessed after every 2nd treatment cycle. Patients may receive a maximum of 12 cycles of treatment under this research protocol.
1199083|NCT00301418|E1|Reported Event|Tarceva (Erlotinib)|Erlotinib: Tarceva®: Will be given at a starting dose of 150mg QD dose for the first cycle which is 28 days. This will be followed by 14 days of 100mg PO on a bid schedule and 150mg PO on a bid schedule for the final 14 days of the second cycle. Assuming no dose limiting toxicity, 150 mg PO tid will be continued for up to 10 more cycles. This is an outpatient regimen, in which the drug is admininistered orally. Tumor response will be assessed after every 2nd treatment cycle. Patients may receive a maximum of 12 cycles of treatment under this research protocol.
1199084|NCT00301366|B1|Baseline|Entered Study|
1199085|NCT00301366|P1|Participant Flow|Alpha-1MP Treatment Group|All subjects received open-label weekly IV infusions of 60 mg/kg body weight of functional Alpha-1 MP for 20 weeks
1199086|NCT00301366|O1|Outcome|Alpha-1 MP Treatment Group|
1199087|NCT00301366|E1|Reported Event|Alpha-1MP Treatment Group|All subjects received open-label weekly IV infusions of 60 mg/kg body weight of functional Alpha-1 MP for 20 weeks
1199088|NCT00301262|B3|Baseline|Total|Total of all reporting groups
1199089|NCT00301262|B2|Baseline|Start : DB Placebo|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).
1199090|NCT00301262|B1|Baseline|Start : DB Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks).
1199091|NCT00301262|P2|Participant Flow|DB Placebo/OL Viagra|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
1199092|NCT00301262|P1|Participant Flow|DB Viagra / OL Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
1199093|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
1199094|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
1199095|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
1199096|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
1199097|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
1199098|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
1199099|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
1199100|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
1199101|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
1199102|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
1199103|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
1199104|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
1199105|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
1199106|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
1199107|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
1199108|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
1199109|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
1199110|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
1199126|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
1199127|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
1199128|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
1199129|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
1199130|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
1199131|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
1199132|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
1199167|NCT00301262|O2|Outcome|DB Placebo|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).
1199168|NCT00301262|O1|Outcome|DB Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)
1199169|NCT00301262|O2|Outcome|DB Placebo|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).
1199170|NCT00301262|O1|Outcome|DB Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)
1199171|NCT00301262|O2|Outcome|DB Placebo|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).
1199172|NCT00301262|O1|Outcome|DB Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)
1199173|NCT00301262|O2|Outcome|DB Placebo|
1199174|NCT00301262|O1|Outcome|DB Viagra|
1199175|NCT00301262|O2|Outcome|DB Placebo/OL Viagra|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
1199176|NCT00301262|O1|Outcome|DB Viagra / OL Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
1199177|NCT00301262|O2|Outcome|DB Placebo/OL Viagra|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
1199178|NCT00301262|O1|Outcome|DB Viagra / OL Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
1199257|NCT00301080|O3|Outcome|D-cycloserine 200mg|D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
1199179|NCT00301262|O2|Outcome|DB Placebo|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).
1199180|NCT00301262|O1|Outcome|DB Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)
1199181|NCT00301262|O2|Outcome|DB Placebo|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).
1199182|NCT00301262|O1|Outcome|DB Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)
1199183|NCT00301262|O4|Outcome|Week 14 DB Placebo/OL Viagra|
1199184|NCT00301262|O3|Outcome|Week 14 DB Viagra/OL Viagra|
1199185|NCT00301262|O2|Outcome|Week 8 DB Placebo|
1199186|NCT00301262|O1|Outcome|Week 8 DB Viagra|
1199187|NCT00301262|O4|Outcome|Week 14 DB Placebo/OL Viagra|
1199188|NCT00301262|O3|Outcome|Week 14 DB Viagra/OL Viagra|
1199189|NCT00301262|O2|Outcome|Week 8 DB Placebo|
1199190|NCT00301262|O1|Outcome|Week 8 DB Viagra|
1199191|NCT00301262|O4|Outcome|Week 14 DB Placebo/OL Viagra|
1199192|NCT00301262|O3|Outcome|Week 14 DB Viagra/OL Viagra|
1199193|NCT00301262|O2|Outcome|Week 8 DB Placebo|
1199194|NCT00301262|O1|Outcome|Week 8 DB Viagra|
1199195|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
1199196|NCT00301262|O3|Outcome|DB Placebo Week 8|
1199197|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
1199198|NCT00301262|O1|Outcome|DB Viagra Week 8|
1199199|NCT00301262|O2|Outcome|DB Placebo|
1199200|NCT00301262|O1|Outcome|DB Viagra|
1199201|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
1199202|NCT00301262|O3|Outcome|DB Placebo Week 8|
1199203|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
1199204|NCT00301262|O1|Outcome|DB Viagra Week 8|
1199205|NCT00301262|O2|Outcome|DB Placebo|
1199206|NCT00301262|O1|Outcome|DB Viagra|
1199207|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
1199208|NCT00301262|O3|Outcome|DB Placebo Week 8|
1199209|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
1199210|NCT00301262|O1|Outcome|DB Viagra Week 8|
1199211|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
1199223|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
1199224|NCT00301262|O3|Outcome|DB Placebo Week 8|
1199225|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
1199226|NCT00301262|O1|Outcome|DB Viagra Week 8|
1199227|NCT00301262|O2|Outcome|DB Placebo|
1199228|NCT00301262|O1|Outcome|DB Viagra|
1199229|NCT00301262|O2|Outcome|DB Placebo|
1199230|NCT00301262|O1|Outcome|DB Viagra|
1199231|NCT00301262|O2|Outcome|DB Placebo|
1199232|NCT00301262|O1|Outcome|DB Viagra|
1199233|NCT00301262|O2|Outcome|DB Placebo|
1199234|NCT00301262|O1|Outcome|DB Viagra|
1199235|NCT00301262|O2|Outcome|DB Placebo|
1199236|NCT00301262|O1|Outcome|DB Viagra|
1199237|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
1199238|NCT00301262|O3|Outcome|DB Placebo Week 8|
1199239|NCT00301262|O2|Outcome|DB Viagra /OL Viagra Week 14|
1199240|NCT00301262|O1|Outcome|DB Viagra Week 8|
1199241|NCT00301262|O2|Outcome|DB Placebo|
1199242|NCT00301262|O1|Outcome|DB Viagra|
1199243|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
1199244|NCT00301262|O3|Outcome|DB Placebo Week 8|
1199245|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
1199246|NCT00301262|O1|Outcome|DB Viagra Week 8|
1199247|NCT00301262|O2|Outcome|DB Placebo|
1199248|NCT00301262|O1|Outcome|DB Viagra|
1199249|NCT00301080|B1|Baseline|All Participants (Original Version)|All 7 patients enrolled were during the original version of the study design (2 arms: d-cycloserine 250mg vs. placebo - twice daily for 4 weeks). Since the study went on to change design and then terminate prior to completing accrual, it is not useful to report baseline measures by the original arms/groups.
1199250|NCT00301080|P5|Participant Flow|Placebo (Revised Version)|Placebo administered orally at a dose of twice per day for 12 weeks.
1199251|NCT00301080|P4|Participant Flow|D-cycloserine 50 mg|D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
1199252|NCT00301080|P3|Participant Flow|D-cycloserine 200mg|D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
1199253|NCT00301080|P2|Participant Flow|Placebo (Original Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
1199254|NCT00301080|P1|Participant Flow|D-cycloserine 250mg|This was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks.
1199255|NCT00301080|O5|Outcome|Placebo (Revised Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
1199256|NCT00301080|O4|Outcome|D-cycloserine 50 mg|D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
1199258|NCT00301080|O2|Outcome|Placebo (Original Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
1199259|NCT00301080|O1|Outcome|D-cycloserine 250mg|This was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks.
1199260|NCT00301080|O5|Outcome|Placebo (Revised Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
1199261|NCT00301080|O4|Outcome|D-cycloserine 50 mg|D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
1199262|NCT00301080|O3|Outcome|D-cycloserine 200mg|D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
1199263|NCT00301080|O2|Outcome|Placebo (Original Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
1199264|NCT00301080|O1|Outcome|D-cycloserine 250mg|This was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks.
1199265|NCT00301080|O5|Outcome|Placebo (Revised Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
1199266|NCT00301080|O4|Outcome|D-cycloserine 50 mg|D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
1199267|NCT00301080|O3|Outcome|D-cycloserine 200mg|D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
1199268|NCT00301080|O2|Outcome|Placebo (Original Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
1199269|NCT00301080|O1|Outcome|D-cycloserine 250mg|This was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks.
1199270|NCT00301080|O5|Outcome|Placebo (Revised Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
1199271|NCT00301080|O4|Outcome|D-cycloserine 50 mg|D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
1199272|NCT00301080|O3|Outcome|D-cycloserine 200mg|D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
1199273|NCT00301080|O2|Outcome|Placebo (Original Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
1199274|NCT00301080|O1|Outcome|D-cycloserine 250mg|This was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks.
1199275|NCT00301080|O5|Outcome|Placebo (Revised Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
1199276|NCT00301080|O4|Outcome|D-cycloserine 50 mg|D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
1199277|NCT00301080|O3|Outcome|D-cycloserine 200mg|D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
1199278|NCT00301080|O2|Outcome|Placebo (Original Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
1199279|NCT00301080|O1|Outcome|D-cycloserine 250mg|This was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks.
1199280|NCT00301080|E2|Reported Event|D-cycloserine 250mg|
1199281|NCT00301080|E1|Reported Event|Placebo (Original Version)|
1199282|NCT00301028|B1|Baseline|Cetuximab + Carboplatin/Paclitaxel|Cetuximab beginning weekly dose 400 mg/m^2 intravenous (IV), and 250 mg/m^2 weeks 2-6; Weekly Carboplatin AUC 2 and Paclitaxel 135 mg/m^2 for 6 courses.
1199385|NCT00300482|O5|Outcome|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
1199386|NCT00300482|O4|Outcome|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
1199283|NCT00301028|P1|Participant Flow|Cetuximab + Carboplatin/Paclitaxel|Cetuximab beginning weekly dose 400 mg/m^2 intravenous (IV), and 250 mg/m^2 weeks 2-6; Weekly Carboplatin Area Under the Curve (AUC) 2 and Paclitaxel 135 mg/m^2 for 6 courses.
1199284|NCT00301028|O1|Outcome|Cetuximab + Carboplatin/Paclitaxel|Cetuximab beginning weekly dose 400 mg/m^2 intravenous (IV), and 250 mg/m^2 weeks 2-6; Weekly Carboplatin AUC 2 and Paclitaxel 135 mg/m^2 for 6 courses.
1199285|NCT00301028|E1|Reported Event|Cetuximab + Carboplatin/Paclitaxel|Cetuximab beginning weekly dose 400 mg/m^2 intravenous (IV), and 250 mg/m^2 weeks 2-6; Weekly Carboplatin AUC 2 and Paclitaxel 135 mg/m^2 for 6 courses.
1199286|NCT00300885|B3|Baseline|Total|Total of all reporting groups
1199287|NCT00300885|B2|Baseline|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
1199288|NCT00300885|B1|Baseline|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
1199289|NCT00300885|P2|Participant Flow|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
1199290|NCT00300885|P1|Participant Flow|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
1199291|NCT00300885|O2|Outcome|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
1199292|NCT00300885|O1|Outcome|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
1199415|NCT00300482|E5|Reported Event|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
1199293|NCT00300885|O2|Outcome|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
1199294|NCT00300885|O1|Outcome|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
1199295|NCT00300885|O2|Outcome|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
1199296|NCT00300885|O1|Outcome|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
1199297|NCT00300885|O2|Outcome|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
1199298|NCT00300885|O1|Outcome|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
1199299|NCT00300885|O2|Outcome|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
1199300|NCT00300885|O1|Outcome|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
1199301|NCT00300885|O2|Outcome|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
1199331|NCT00300742|O1|Outcome|Topiramate/BBCET|Escalating dose of up to 300 mg/day of Topiramate, plus BBCET (Brief Behavioral Compliance Enhancement Treatment)at 12 weekly visits following the initial baseline and randomization visits
1199302|NCT00300885|O1|Outcome|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
1199303|NCT00300885|E2|Reported Event|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
1199304|NCT00300885|E1|Reported Event|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
1199305|NCT00300755|B4|Baseline|Total|Total of all reporting groups
1199306|NCT00300755|B3|Baseline|High Dose Pantoprazole (Approximately 1.2 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years.
1199307|NCT00300755|B2|Baseline|Medium Dose Pantoprazole (Approximately 0.6 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
1199308|NCT00300755|B1|Baseline|Low Dose Pantoprazole (Approximately 0.3 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
1199309|NCT00300755|P3|Participant Flow|High Dose Pantoprazole (Approximately 1.2 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years.
1199310|NCT00300755|P2|Participant Flow|Medium Dose Pantoprazole (Approximately 0.6 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
1199311|NCT00300755|P1|Participant Flow|Low Dose Pantoprazole (Approximately 0.3 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
1199312|NCT00300755|O3|Outcome|High Dose Pantoprazole (Approximately 1.2 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years.
1199313|NCT00300755|O2|Outcome|Medium Dose Pantoprazole (Approximately 0.6 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
1199314|NCT00300755|O1|Outcome|Low Dose Pantoprazole (Approximately 0.3 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
1200529|NCT00297102|P2|Participant Flow|Placebo|once daily
1199315|NCT00300755|O3|Outcome|High Dose Pantoprazole (Approximately 1.2 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years.
1199316|NCT00300755|O2|Outcome|Medium Dose Pantoprazole (Approximately 0.6 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
1199317|NCT00300755|O1|Outcome|Low Dose Pantoprazole (Approximately 0.3 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
1199318|NCT00300755|O3|Outcome|High Dose Pantoprazole (Approximately 1.2 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years.
1199319|NCT00300755|O2|Outcome|Medium Dose Pantoprazole (Approximately 0.6 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
1199320|NCT00300755|O1|Outcome|Low Dose Pantoprazole (Approximately 0.3 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
1199321|NCT00300755|O3|Outcome|High Dose Pantoprazole (Approximately 1.2 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years.
1199322|NCT00300755|O2|Outcome|Medium Dose Pantoprazole (Approximately 0.6 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
1199323|NCT00300755|O1|Outcome|Low Dose Pantoprazole (Approximately 0.3 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
1199324|NCT00300755|E3|Reported Event|High Dose Pantoprazole (Approximately 1.2 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years.
1199325|NCT00300755|E2|Reported Event|Medium Dose Pantoprazole (Approximately 0.6 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
1199326|NCT00300755|E1|Reported Event|Low Dose Pantoprazole (Approximately 0.3 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
1199327|NCT00300742|B1|Baseline|Topiramate/BBCET|Escalating dose of up to 300 mg/day of Topiramate
1199328|NCT00300742|P1|Participant Flow|Topiramate/BBCET|Escalating dose of up to 300 mg/day of Topiramate
1199329|NCT00300742|O1|Outcome|Topiramate/BBCET|Patients receiving an escalating dose of up to 300 mg/day of Topiramate, plus BBCET (Brief Behavioral Compliance Enhancement Treatment)
1199330|NCT00300742|O1|Outcome|Topiramate/BBCET|Escalating dose of up to 300 mg/day of Topiramate, plus BBCET (Brief Behavioral Compliance Enhancement Treatment)at 12 weekly visits following the initial baseline and randomization visits
1199384|NCT00300482|O6|Outcome|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
1199332|NCT00300742|O1|Outcome|Topiramate/BBCET|Escalating dose of up to 300 mg/day of Topiramate, plus BBCET (Brief Behavioral Compliance Enhancement Treatment)at 12 weekly visits following the initial baseline and randomization visits
1199333|NCT00300742|O1|Outcome|Topiramate/BBCET|Patients receiving an escalating dose of up to 300 mg/day of Topiramate, plus BBCET (Brief Behavioral Compliance Enhancement Treatment)
1199334|NCT00300742|E1|Reported Event|Topiramate/BBCET|Escalating dose of up to 300 mg/day of Topiramate
1199335|NCT00300677|B1|Baseline|Voriconazole|400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3
1199336|NCT00300677|P1|Participant Flow|Voriconazole|400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3
1199337|NCT00300677|O1|Outcome|Voriconazole|400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3
1199338|NCT00300677|O1|Outcome|Voriconazole|400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3
1199339|NCT00300677|O1|Outcome|Voriconazole|400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3
1199340|NCT00300677|O1|Outcome|Voriconazole|400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3
1199341|NCT00300677|E1|Reported Event|Voriconazole|400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3
1199342|NCT00300495|B3|Baseline|Total|Total of all reporting groups
1199343|NCT00300495|B2|Baseline|2 - Control|"Control arm, standard care with no perioperative amiodarone~Control arm, standard care: Control"
1199344|NCT00300495|B1|Baseline|1 - Amiodarone|"Perioperative amiodarone~Amiodarone: Perioperative orally administered"
1199345|NCT00300495|P2|Participant Flow|2 - Control|"Control arm, standard care with no perioperative amiodarone~Control arm, standard care: Control"
1199346|NCT00300495|P1|Participant Flow|1 - Amiodarone|"Perioperative amiodarone~Amiodarone: Perioperative orally administered~Patients received 200 mg of amiodarone three times a day for one week prior to surgery and 200 mg twice a day for one week after the surgery"
1199347|NCT00300495|O2|Outcome|2 - Control|"Control arm, standard care with no perioperative amiodarone~Control arm, standard care: Control"
1199348|NCT00300495|O1|Outcome|1 - Amiodarone|"Perioperative amiodarone~Amiodarone: Perioperative orally administered~Patients received 200 mg of amiodarone three times a day for one week prior to surgery and 200 mg twice a day for one week after the surgery"
1199349|NCT00300495|O2|Outcome|2 - Control|"Control arm, standard care with no perioperative amiodarone~Control arm, standard care: Control"
1199350|NCT00300495|O1|Outcome|1 - Amiodarone|"Perioperative amiodarone~Amiodarone: Perioperative orally administered~Patients received 200 mg of amiodarone three times a day for one week prior to surgery and 200 mg twice a day for one week after the surgery"
1199351|NCT00300495|E2|Reported Event|2 - Control|"Control arm, standard care with no perioperative amiodarone~Control arm, standard care: Control"
1199416|NCT00300482|E4|Reported Event|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
1199417|NCT00300482|E3|Reported Event|ABT-335|ABT-335 monotherapy once daily
1199352|NCT00300495|E1|Reported Event|1 - Amiodarone|"Perioperative amiodarone~Amiodarone: Perioperative orally administered~Patients received 200 mg of amiodarone three times a day for one week prior to surgery and 200 mg twice a day for one week after the surgery"
1199353|NCT00300482|B7|Baseline|Total|Total of all reporting groups
1199354|NCT00300482|B6|Baseline|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
1199355|NCT00300482|B5|Baseline|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
1199356|NCT00300482|B4|Baseline|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
1199357|NCT00300482|B3|Baseline|ABT-335|ABT-335 monotherapy once daily
1199358|NCT00300482|B2|Baseline|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
1199359|NCT00300482|B1|Baseline|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
1199360|NCT00300482|P6|Participant Flow|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
1199361|NCT00300482|P5|Participant Flow|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
1199362|NCT00300482|P4|Participant Flow|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
1199363|NCT00300482|P3|Participant Flow|ABT-335|ABT-335 monotherapy once daily
1199364|NCT00300482|P2|Participant Flow|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
1199365|NCT00300482|P1|Participant Flow|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
1199366|NCT00300482|O6|Outcome|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
1199367|NCT00300482|O5|Outcome|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
1199368|NCT00300482|O4|Outcome|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
1199369|NCT00300482|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
1199370|NCT00300482|O2|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
1199371|NCT00300482|O1|Outcome|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
1199372|NCT00300482|O6|Outcome|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
1199373|NCT00300482|O5|Outcome|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
1199374|NCT00300482|O4|Outcome|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
1199375|NCT00300482|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
1199376|NCT00300482|O2|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
1199377|NCT00300482|O1|Outcome|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
1199378|NCT00300482|O6|Outcome|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
1199379|NCT00300482|O5|Outcome|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
1199380|NCT00300482|O4|Outcome|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
1199381|NCT00300482|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
1199382|NCT00300482|O2|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
1199383|NCT00300482|O1|Outcome|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
1199387|NCT00300482|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
1199388|NCT00300482|O2|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
1199389|NCT00300482|O1|Outcome|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
1199390|NCT00300482|O6|Outcome|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
1199391|NCT00300482|O5|Outcome|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
1199392|NCT00300482|O4|Outcome|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
1199393|NCT00300482|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
1199394|NCT00300482|O2|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
1199395|NCT00300482|O1|Outcome|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
1199396|NCT00300482|O6|Outcome|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
1199397|NCT00300482|O5|Outcome|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
1199398|NCT00300482|O4|Outcome|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
1199399|NCT00300482|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
1199400|NCT00300482|O2|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
1199401|NCT00300482|O1|Outcome|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
1199402|NCT00300482|O6|Outcome|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
1199403|NCT00300482|O5|Outcome|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
1199404|NCT00300482|O4|Outcome|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
1199405|NCT00300482|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
1199406|NCT00300482|O2|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
1199407|NCT00300482|O1|Outcome|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
1199408|NCT00300482|O6|Outcome|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
1199409|NCT00300482|O5|Outcome|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
1199410|NCT00300482|O4|Outcome|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
1199411|NCT00300482|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
1199412|NCT00300482|O2|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
1199413|NCT00300482|O1|Outcome|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
1199414|NCT00300482|E6|Reported Event|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
1200790|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1199418|NCT00300482|E2|Reported Event|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
1199419|NCT00300482|E1|Reported Event|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
1199420|NCT00300469|B7|Baseline|Total|Total of all reporting groups
1199421|NCT00300469|B6|Baseline|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
1199422|NCT00300469|B5|Baseline|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
1199423|NCT00300469|B4|Baseline|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
1199424|NCT00300469|B3|Baseline|ABT-335|ABT-335 monotherapy once daily
1199425|NCT00300469|B2|Baseline|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
1199426|NCT00300469|B1|Baseline|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
1199427|NCT00300469|P6|Participant Flow|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
1199428|NCT00300469|P5|Participant Flow|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
1199429|NCT00300469|P4|Participant Flow|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
1199430|NCT00300469|P3|Participant Flow|ABT-335|ABT-335 monotherapy once daily
1199431|NCT00300469|P2|Participant Flow|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
1199432|NCT00300469|P1|Participant Flow|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
1199433|NCT00300469|O6|Outcome|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
1199434|NCT00300469|O5|Outcome|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
1199435|NCT00300469|O4|Outcome|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
1199436|NCT00300469|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
1199437|NCT00300469|O2|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
1199438|NCT00300469|O1|Outcome|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
1199439|NCT00300469|O6|Outcome|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
1199440|NCT00300469|O5|Outcome|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
1199441|NCT00300469|O4|Outcome|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
1199442|NCT00300469|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
1199443|NCT00300469|O2|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
1199444|NCT00300469|O1|Outcome|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
1199445|NCT00300469|O6|Outcome|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
1199446|NCT00300469|O5|Outcome|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
1199447|NCT00300469|O4|Outcome|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
1199448|NCT00300469|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
1199449|NCT00300469|O2|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
1199450|NCT00300469|O1|Outcome|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
1199451|NCT00300469|O6|Outcome|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
1199452|NCT00300469|O5|Outcome|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
1199453|NCT00300469|O4|Outcome|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
1199454|NCT00300469|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
1199455|NCT00300469|O2|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
1199456|NCT00300469|O1|Outcome|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
1199457|NCT00300469|O6|Outcome|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
1199458|NCT00300469|O5|Outcome|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
1199459|NCT00300469|O4|Outcome|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
1199460|NCT00300469|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
1199461|NCT00300469|O2|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
1199462|NCT00300469|O1|Outcome|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
1199463|NCT00300469|O6|Outcome|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
1199464|NCT00300469|O5|Outcome|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
1199465|NCT00300469|O4|Outcome|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
1199466|NCT00300469|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
1199467|NCT00300469|O2|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
1199468|NCT00300469|O1|Outcome|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
1199469|NCT00300469|O6|Outcome|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
1199470|NCT00300469|O5|Outcome|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
1199471|NCT00300469|O4|Outcome|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
1199472|NCT00300469|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
1199473|NCT00300469|O2|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
1199474|NCT00300469|O1|Outcome|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
1199475|NCT00300469|O6|Outcome|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
1199476|NCT00300469|O5|Outcome|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
1199477|NCT00300469|O4|Outcome|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
1199478|NCT00300469|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
1199479|NCT00300469|O2|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
1199480|NCT00300469|O1|Outcome|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
1199481|NCT00300469|E6|Reported Event|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
1200791|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1199482|NCT00300469|E5|Reported Event|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
1199483|NCT00300469|E4|Reported Event|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
1199484|NCT00300469|E3|Reported Event|ABT-335|ABT-335 monotherapy once daily
1199485|NCT00300469|E2|Reported Event|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
1199486|NCT00300469|E1|Reported Event|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
1199487|NCT00300456|B7|Baseline|Total|Total of all reporting groups
1199488|NCT00300456|B6|Baseline|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
1199489|NCT00300456|B5|Baseline|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
1199490|NCT00300456|B4|Baseline|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
1199491|NCT00300456|B3|Baseline|ABT-335|ABT-335 monotherapy once daily
1199492|NCT00300456|B2|Baseline|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
1199493|NCT00300456|B1|Baseline|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
1199494|NCT00300456|P6|Participant Flow|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
1199495|NCT00300456|P5|Participant Flow|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
1199496|NCT00300456|P4|Participant Flow|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
1199497|NCT00300456|P3|Participant Flow|ABT-335|ABT-335 monotherapy once daily
1199498|NCT00300456|P2|Participant Flow|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
1199499|NCT00300456|P1|Participant Flow|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
1199500|NCT00300456|O6|Outcome|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
1199501|NCT00300456|O5|Outcome|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
1199502|NCT00300456|O4|Outcome|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
1199503|NCT00300456|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
1199504|NCT00300456|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
1199505|NCT00300456|O1|Outcome|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
1199506|NCT00300456|O6|Outcome|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
1199507|NCT00300456|O5|Outcome|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
1199508|NCT00300456|O4|Outcome|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
1199509|NCT00300456|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
1199510|NCT00300456|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
1199511|NCT00300456|O1|Outcome|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
1199512|NCT00300456|O6|Outcome|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
1199513|NCT00300456|O5|Outcome|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
1199514|NCT00300456|O4|Outcome|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
1199515|NCT00300456|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
1199516|NCT00300456|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
1199517|NCT00300456|O1|Outcome|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
1199518|NCT00300456|O6|Outcome|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
1199519|NCT00300456|O5|Outcome|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
1199520|NCT00300456|O4|Outcome|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
1199521|NCT00300456|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
1199522|NCT00300456|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
1199523|NCT00300456|O1|Outcome|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
1199524|NCT00300456|O6|Outcome|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
1199525|NCT00300456|O5|Outcome|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
1199526|NCT00300456|O4|Outcome|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
1199527|NCT00300456|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
1199528|NCT00300456|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
1199529|NCT00300456|O1|Outcome|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
1199530|NCT00300456|O6|Outcome|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
1199531|NCT00300456|O5|Outcome|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
1199532|NCT00300456|O4|Outcome|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
1199533|NCT00300456|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
1199534|NCT00300456|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
1199535|NCT00300456|O1|Outcome|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
1199536|NCT00300456|O6|Outcome|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
1199537|NCT00300456|O5|Outcome|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
1199538|NCT00300456|O4|Outcome|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
1199539|NCT00300456|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
1199540|NCT00300456|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
1199541|NCT00300456|O1|Outcome|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
1199542|NCT00300456|O6|Outcome|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
1199543|NCT00300456|O5|Outcome|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
1199544|NCT00300456|O4|Outcome|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
1199545|NCT00300456|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
1199546|NCT00300456|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
1199547|NCT00300456|O1|Outcome|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
1199548|NCT00300456|E6|Reported Event|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
1199549|NCT00300456|E5|Reported Event|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
1199550|NCT00300456|E4|Reported Event|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
1199551|NCT00300456|E3|Reported Event|ABT-335|ABT-335 monotherapy once daily
1199552|NCT00300456|E2|Reported Event|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
1199553|NCT00300456|E1|Reported Event|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
1199554|NCT00300430|B4|Baseline|Total|Total of all reporting groups
1199555|NCT00300430|B3|Baseline|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
1199556|NCT00300430|B2|Baseline|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
1199557|NCT00300430|B1|Baseline|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
1199558|NCT00300430|P3|Participant Flow|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
1199559|NCT00300430|P2|Participant Flow|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
1199560|NCT00300430|P1|Participant Flow|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
1199561|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
1199562|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
1199563|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
1199564|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
1199565|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
1199566|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
1199567|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
1199568|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
1199569|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
1199570|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
1199571|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
1199572|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
1199573|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
1199574|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
1199575|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
1199576|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
1199577|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
1199578|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
1199579|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
1199580|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
1199581|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
1199582|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
1199583|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
1199584|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
1199585|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
1199586|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
1199587|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
1199588|NCT00300430|E3|Reported Event|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
1199589|NCT00300430|E2|Reported Event|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
1199590|NCT00300430|E1|Reported Event|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
1199591|NCT00300274|B4|Baseline|Total|Total of all reporting groups
1199592|NCT00300274|B3|Baseline|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
1199593|NCT00300274|B2|Baseline|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
1199594|NCT00300274|B1|Baseline|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
1199595|NCT00300274|P3|Participant Flow|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
1199596|NCT00300274|P2|Participant Flow|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
1199597|NCT00300274|P1|Participant Flow|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
1199598|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
1199599|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
1199600|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
1199601|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
1199602|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
1199603|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
1199604|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
1199605|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
1199606|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
1199607|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
1199669|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199608|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
1199609|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
1199610|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
1199611|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
1199612|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
1199613|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
1199614|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
1199615|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
1199616|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
1199651|NCT00300235|E1|Reported Event|Age 5-9.9 HbSS/HbSβ0|Subjects 5 to 9.9 yrs w/SCD diagnosis HbSS/HbSβ0
1199652|NCT00299975|B4|Baseline|Total|Total of all reporting groups
1200432|NCT00297427|O1|Outcome|Acupuncture|True acupuncture twice a week for 6 weeks
1199617|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
1199618|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
1199619|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
1199620|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
1199621|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
1199622|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
1199623|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
1199624|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
1199625|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
1199626|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
1199670|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1200009|NCT00299000|O2|Outcome|Naglazyme, 2.0 mg/kg|weekly infusions for minimum of 52 weeks
1199627|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
1199628|NCT00300274|E3|Reported Event|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
1199629|NCT00300274|E2|Reported Event|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
1199630|NCT00300274|E1|Reported Event|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
1199631|NCT00300235|B6|Baseline|Total|Total of all reporting groups
1199632|NCT00300235|B5|Baseline|Age >15 HbSC/HbSβ+|Subjects > 15 yrs w/SCD diagnosis HbSC/HbSβ+
1199633|NCT00300235|B4|Baseline|Age >25 HbSS/HbSβ0|Subjects > 25 yrs w/SCD diagnosis HbSS/HbSβ0
1199634|NCT00300235|B3|Baseline|Age 15-24.9 HbSS/HbSβ0|Subjects 15 to 24.9 yrs w/SCD diagnosis HbSS/HbSβ0
1199635|NCT00300235|B2|Baseline|Age 10-14.9 HbSS/HbSβ0|Subjects 10 to 14.9 ys w/SCD diagnosis HbSS/HbSβ0
1199636|NCT00300235|B1|Baseline|Age 5-9.9 HbSS/HbSβ0|Subjects 5 to 9.9 yrs w/SCD diagnosis HbSS/HbSβ0
1199637|NCT00300235|P5|Participant Flow|Age >15 HbSC/HbSβ+|Subjects > 15 yrs w/SCD diagnosis HbSC/HbSβ+
1199638|NCT00300235|P4|Participant Flow|Age >25 HbSS/HbSβ0|Subjects > 25 yrs w/SCD diagnosis HbSS/HbSβ0
1199639|NCT00300235|P3|Participant Flow|Age 15-24.9 HbSS/HbSβ0|Subjects 15 to 24.9 yrs w/SCD diagnosis HbSS/HbSβ0
1199640|NCT00300235|P2|Participant Flow|Age 10-14.9 HbSS/HbSβ0|Subjects 10 to 14.9 ys w/SCD diagnosis HbSS/HbSβ0
1199641|NCT00300235|P1|Participant Flow|Age 5-9.9 HbSS/HbSβ0|Subjects 5 to 9.9 yrs w/SCD diagnosis HbSS/HbSβ0
1199642|NCT00300235|O5|Outcome|Age >15 HbSC/HbSβ+|Subjects > 15 yrs w/SCD diagnosis HbSC/HbSβ+
1199643|NCT00300235|O4|Outcome|Age >25 HbSS/HbSβ0|Subjects > 25 yrs w/SCD diagnosis HbSS/HbSβ0
1199644|NCT00300235|O3|Outcome|Age 15-24.9 HbSS/HbSβ0|Subjects 15 to 24.9 yrs w/SCD diagnosis HbSS/HbSβ0
1199645|NCT00300235|O2|Outcome|Age 10-14.9 HbSS/HbSβ0|Subjects 10 to 14.9 ys w/SCD diagnosis HbSS/HbSβ0
1199646|NCT00300235|O1|Outcome|Age 5-9.9 HbSS/HbSβ0|Subjects 5 to 9.9 yrs w/SCD diagnosis HbSS/HbSβ0
1199647|NCT00300235|E5|Reported Event|Age >15 HbSC/HbSβ+|Subjects > 15 yrs w/SCD diagnosis HbSC/HbSβ+
1199648|NCT00300235|E4|Reported Event|Age >25 HbSS/HbSβ0|Subjects > 25 yrs w/SCD diagnosis HbSS/HbSβ0
1199649|NCT00300235|E3|Reported Event|Age 15-24.9 HbSS/HbSβ0|Subjects 15 to 24.9 yrs w/SCD diagnosis HbSS/HbSβ0
1199650|NCT00300235|E2|Reported Event|Age 10-14.9 HbSS/HbSβ0|Subjects 10 to 14.9 ys w/SCD diagnosis HbSS/HbSβ0
1199653|NCT00299975|B3|Baseline|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199654|NCT00299975|B2|Baseline|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199655|NCT00299975|B1|Baseline|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199656|NCT00299975|P3|Participant Flow|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199657|NCT00299975|P2|Participant Flow|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199658|NCT00299975|P1|Participant Flow|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199659|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199660|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199661|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199662|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199663|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199664|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199665|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199666|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199667|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199668|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199671|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199672|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199673|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199674|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199675|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199676|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199677|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199678|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199679|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199680|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199681|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199682|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199683|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199684|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199685|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199686|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199687|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199688|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199689|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199690|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199691|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199692|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199693|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199694|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199695|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199696|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199697|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199698|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199699|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199700|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199701|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199702|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199703|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199704|NCT00299975|E3|Reported Event|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199705|NCT00299975|E2|Reported Event|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199706|NCT00299975|E1|Reported Event|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
1199707|NCT00299741|B1|Baseline|Metastatic Prostate Cancer Treated With Sunitinib|Sunitinib
1199708|NCT00299741|P1|Participant Flow|Metastatic Prostate Cancer Treated With Sunitinib|Sunitinib administered orally at a dosage of 37.5 mg once daily
1199709|NCT00299741|O1|Outcome|Metastatic Prostate Cancer Treated With Sunitinib|Sunitinib
1199710|NCT00299741|O1|Outcome|Metastatic Prostate Cancer Treated With Sunitinib|Sunitinib
1199711|NCT00299741|E1|Reported Event|Metastatic Prostate Cancer Treated With Sunitinib|Sunitinib
1199712|NCT00299702|B3|Baseline|Total|Total of all reporting groups
1199713|NCT00299702|B2|Baseline|Abilify|10-30 mg once daily oral for 104 weeks
1199714|NCT00299702|B1|Baseline|Risperdal Consta|25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks
1199715|NCT00299702|P2|Participant Flow|Abilify|10-30 mg once daily oral for 104 weeks
1199716|NCT00299702|P1|Participant Flow|Risperdal Consta|25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks
1199717|NCT00299702|O2|Outcome|Abilify|10-30 mg once daily oral for 104 weeks
1199718|NCT00299702|O1|Outcome|Risperdal Consta|25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks
1199719|NCT00299702|O2|Outcome|Abilify|10-30 mg once daily oral for 104 weeks
1199720|NCT00299702|O1|Outcome|Risperdal Consta|25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks
1199721|NCT00299702|E2|Reported Event|Abilify|10-30 mg once daily oral for 104 weeks
1199722|NCT00299702|E1|Reported Event|RISPERDAL CONSTA|25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks
1199723|NCT00299689|B1|Baseline|Intervention|"Single-arm: Ontak~Denileukin diftitox : 12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles."
1199724|NCT00299689|P1|Participant Flow|Intervention|"Single-arm: Ontak~Denileukin diftitox : 12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles."
1199725|NCT00299689|O1|Outcome|Intervention|"Single-arm: Ontak~Denileukin diftitox : 12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles."
1199726|NCT00299689|E1|Reported Event|Intervention|"Single-arm: Ontak~Denileukin diftitox : 12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles."
1199727|NCT00299546|B4|Baseline|Total|Total of all reporting groups
1199728|NCT00299546|B3|Baseline|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
1199729|NCT00299546|B2|Baseline|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); Golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
1199730|NCT00299546|B1|Baseline|Group 1: Placebo|Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); Golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; Golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
1199731|NCT00299546|P3|Participant Flow|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
1199732|NCT00299546|P2|Participant Flow|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); Golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
1199733|NCT00299546|P1|Participant Flow|Group 1: Placebo|Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); Golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; Golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
1199734|NCT00299546|O4|Outcome|Combined Golimumab|Combines Group 2 (golimumab 50 mg) and Group 3 (golimumab 100 mg).
1199735|NCT00299546|O3|Outcome|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
1199736|NCT00299546|O2|Outcome|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
1199737|NCT00299546|O1|Outcome|Group 1: Placebo|Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
1199738|NCT00299546|O4|Outcome|Combined Golimumab|Combines Group 2 (golimumab 50 mg) and Group 3 (golimumab 100 mg).
1199739|NCT00299546|O3|Outcome|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
1200010|NCT00299000|O1|Outcome|Naglazyme, 1.0 mg/kg|weekly infusions for minimum of 52 weeks
1199740|NCT00299546|O2|Outcome|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
1199741|NCT00299546|O1|Outcome|Group 1: Placebo|Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
1199742|NCT00299546|O4|Outcome|Combined Golimumab|Combines Group 2 (golimumab 50 mg) and Group 3 (golimumab 100 mg).
1199743|NCT00299546|O3|Outcome|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
1199744|NCT00299546|O2|Outcome|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
1199745|NCT00299546|O1|Outcome|Group 1: Placebo|Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
1199746|NCT00299546|O4|Outcome|Combined Golimumab|Combines Group 2 (golimumab 50 mg) and Group 3 (golimumab 100 mg).
1199747|NCT00299546|O3|Outcome|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
1199748|NCT00299546|O2|Outcome|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
1199749|NCT00299546|O1|Outcome|Group 1: Placebo|Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
1199750|NCT00299546|O4|Outcome|Combined Golimumab|Combines Group 2 (golimumab 50 mg) and Group 3 (golimumab 100 mg).
1199751|NCT00299546|O3|Outcome|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
1199752|NCT00299546|O2|Outcome|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
1199753|NCT00299546|O1|Outcome|Group 1: Placebo|Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
1199754|NCT00299546|E3|Reported Event|Group 3: Golimumab 50 and 100 mg SC Injections|Participants who were treated with golimumab and received at least one injection of both golimumab 50 mg and golimumab 100 mg during the study.
1199755|NCT00299546|E2|Reported Event|Group 2: Golimumab 100 mg SC Injections Only|Participants who were treated with golimumab and received golimumab 100 mg injections only during the study.
1199756|NCT00299546|E1|Reported Event|Group 1: Golimumab 50 mg SC Injections Only|Participants who were treated with golimumab and received golimumab 50 mg injections only during the study.
1199757|NCT00299416|B1|Baseline|Caffeinol|Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg.
1199758|NCT00299416|P1|Participant Flow|Caffeinol|Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg.
1199759|NCT00299416|O1|Outcome|Caffeinol|Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg.
1199760|NCT00299416|O1|Outcome|Caffeinol|Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg.
1199761|NCT00299416|O1|Outcome|Caffeinol|Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg.
1199762|NCT00299416|E1|Reported Event|Caffeinol|Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg.
1199763|NCT00299221|B3|Baseline|Total|Total of all reporting groups
1199764|NCT00299221|B2|Baseline|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
1200011|NCT00299000|O2|Outcome|Naglazyme, 2.0 mg/kg|weekly infusions for minimum of 52 weeks
1200012|NCT00299000|O1|Outcome|Naglazyme, 1.0 mg/kg|weekly infusions for minimum of 52 weeks
1199765|NCT00299221|B1|Baseline|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
1199766|NCT00299221|P2|Participant Flow|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
1199767|NCT00299221|P1|Participant Flow|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
1199768|NCT00299221|O2|Outcome|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
1199769|NCT00299221|O1|Outcome|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
1199770|NCT00299221|O2|Outcome|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
1199771|NCT00299221|O1|Outcome|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
1199772|NCT00299221|O2|Outcome|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
1199773|NCT00299221|O1|Outcome|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
1199774|NCT00299221|O2|Outcome|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
1199775|NCT00299221|O1|Outcome|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
1199776|NCT00299221|O2|Outcome|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
1199777|NCT00299221|O1|Outcome|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
1200433|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
1199778|NCT00299221|E2|Reported Event|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
1199779|NCT00299221|E1|Reported Event|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
1199780|NCT00299156|B4|Baseline|Total|Total of all reporting groups
1199781|NCT00299156|B3|Baseline|Randomized, Oral Clofarabine 20mg|Arm B: 20 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
1199782|NCT00299156|B2|Baseline|Randomized, Oral Clofarabine 10mg|Arm A: 10 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
1199783|NCT00299156|B1|Baseline|Oral Clofarabine|Original dose of 40 mg oral reduced to 30mg and than lower dose of either 10 mg (Group 1) or 20 mg (Group 2) tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
1199784|NCT00299156|P3|Participant Flow|Randomized, Oral Clofarabine 20mg|Arm B: 20 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
1199785|NCT00299156|P2|Participant Flow|Randomized, Oral Clofarabine 10mg|Arm A: 10 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
1199786|NCT00299156|P1|Participant Flow|Oral Clofarabine|Original dose of 40 mg oral reduced to 30mg and than lower dose of either 10 mg (Group 1) or 20 mg (Group 2) tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
1199787|NCT00299156|O3|Outcome|Randomized, Oral Clofarabine 20mg|Arm B: 20 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
1199788|NCT00299156|O2|Outcome|Randomized, Oral Clofarabine 10mg|Arm A: 10 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
1199789|NCT00299156|O1|Outcome|Oral Clofarabine|Original dose of 40 mg oral reduced to 30mg and than lower dose of either 10 mg (Group 1) or 20 mg (Group 2) tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
1199790|NCT00299156|E3|Reported Event|Randomized, Oral Clofarabine 20mg|Arm B: 20 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
1199791|NCT00299156|E2|Reported Event|Randomized, Oral Clofarabine 10mg|Arm A: 10 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
1199792|NCT00299156|E1|Reported Event|Oral Clofarabine|Original dose of 40 mg oral reduced to 30mg and than lower dose of either 10 mg (Group 1) or 20 mg (Group 2) tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
1199793|NCT00299130|B4|Baseline|Total|Total of all reporting groups
1199794|NCT00299130|B3|Baseline|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1200013|NCT00299000|E2|Reported Event|Naglazyme, 2.0 mg/kg|weekly infusions for minimum of 52 weeks
1199795|NCT00299130|B2|Baseline|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199796|NCT00299130|B1|Baseline|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199797|NCT00299130|P3|Participant Flow|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199798|NCT00299130|P2|Participant Flow|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199799|NCT00299130|P1|Participant Flow|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 milligrams (mg) intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199800|NCT00299130|O1|Outcome|Rituximab + MTX|"Participants received 0.5 g or 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199801|NCT00299130|O2|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199802|NCT00299130|O1|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199803|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199804|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199805|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199918|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
1200014|NCT00299000|E1|Reported Event|Naglazyme, 1.0 mg/kg|weekly infusions for minimum of 52 weeks
1200590|NCT00296647|E3|Reported Event|Bupropion|
1199806|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199807|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199808|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199809|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199810|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199811|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199912|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
1200096|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1199812|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199813|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199814|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199815|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199816|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199817|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199818|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199819|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199820|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199821|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199822|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199913|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1200434|NCT00297427|O1|Outcome|Acupuncture|True acupuncture twice a week for 6 weeks
1199823|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199824|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199825|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199826|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199827|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199828|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199829|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199830|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199831|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199832|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199833|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199856|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199834|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199835|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199836|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199837|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199838|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199839|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199840|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199841|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199842|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199843|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199844|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199868|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199845|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199846|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199847|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199848|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199919|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1200323|NCT00297778|P1|Participant Flow|Placebo|Placebo tablet matching active treatment
1199849|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199850|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199851|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199852|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199853|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199854|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199855|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199908|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1200435|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
1199857|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199858|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199859|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199860|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199861|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199862|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199863|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199864|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199865|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199866|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199867|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199909|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
1200097|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1199869|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199870|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199871|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199872|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199873|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199874|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199875|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199876|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199877|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199878|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199879|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199910|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1200436|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
1199880|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199881|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199882|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199883|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199884|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199885|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199886|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199887|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199888|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199889|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199890|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199911|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1200437|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
1199891|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199892|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199893|NCT00299130|E7|Reported Event|Rituximab 2 x 1.0 g + MTX – Extended Safety Follow-up Period|Participants received no treatment during the extended safety follow-up period.
1199894|NCT00299130|E6|Reported Event|Rituximab 2 x 0.5 g + MTX – Extended Safety Follow-up Period|Participants received no treatment during the extended safety follow-up period.
1199895|NCT00299130|E5|Reported Event|Switch Population: Rituximab|Includes all data from the point of switch for participants who switched from Placebo + Methotrexate to treatment with rituximab.
1199896|NCT00299130|E4|Reported Event|Switch Population: Placebo + MTX|Includes all data up to the point of switch for participants in the Placebo + Methotrexate treatment group who switched to treatment with rituximab after Week 24.
1199936|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
1199897|NCT00299130|E3|Reported Event|Rituximab 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199898|NCT00299130|E2|Reported Event|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199899|NCT00299130|E1|Reported Event|Placebo + MTX|"Includes all data for participants who remained on placebo, and data up to the point of switch if the participant switched to treatment with rituximab.~Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
1199900|NCT00299104|B4|Baseline|Total|Total of all reporting groups
1199901|NCT00299104|B3|Baseline|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199902|NCT00299104|B2|Baseline|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199903|NCT00299104|B1|Baseline|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
1199904|NCT00299104|P3|Participant Flow|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199905|NCT00299104|P2|Participant Flow|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199906|NCT00299104|P1|Participant Flow|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
1199907|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1200438|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
1199914|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199915|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
1199916|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199917|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1200004|NCT00299000|P1|Participant Flow|Naglazyme, 1.0 mg/kg|weekly infusions for minimum of 52 weeks
1200005|NCT00299000|O2|Outcome|Naglazyme, 2.0 mg/kg|weekly infusions for minimum of 52 weeks
1199920|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199921|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
1199922|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199923|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199924|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
1199925|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199926|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199927|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
1199928|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199929|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1200058|NCT00298558|O1|Outcome|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
1199930|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
1199931|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199932|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199933|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
1199934|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199935|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199937|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199938|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199939|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
1199940|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199941|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199942|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
1199943|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199944|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199945|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
1199978|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
1200792|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1199946|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199947|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199948|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
1199949|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199950|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199951|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
1200006|NCT00299000|O1|Outcome|Naglazyme, 1.0 mg/kg|weekly infusions for minimum of 52 weeks
1200007|NCT00299000|O2|Outcome|Naglazyme, 2.0 mg/kg|weekly infusions for minimum of 52 weeks
1200008|NCT00299000|O1|Outcome|Naglazyme, 1.0 mg/kg|weekly infusions for minimum of 52 weeks
1199952|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199953|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199954|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
1199955|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199956|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199957|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
1199958|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199959|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199960|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
1199961|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1200054|NCT00298558|O1|Outcome|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
1199962|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199963|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
1199964|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199965|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199966|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
1199967|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199968|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199969|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
1199970|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199971|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199972|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
1199973|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199974|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199975|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
1199976|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199977|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1200055|NCT00298558|O4|Outcome|Control|This group did not complete any cognitive training interventions
1200059|NCT00298558|O4|Outcome|Control|This group did not complete any cognitive training interventions
1200793|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1199979|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199980|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199981|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
1199982|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199983|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199984|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
1199985|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199986|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199987|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
1199988|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199989|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199990|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
1199991|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199992|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199993|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
1199994|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1200056|NCT00298558|O3|Outcome|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
1199995|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199996|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
1199997|NCT00299104|E3|Reported Event|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199998|NCT00299104|E2|Reported Event|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
1199999|NCT00299104|E1|Reported Event|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
1200000|NCT00299000|B3|Baseline|Total|Total of all reporting groups
1200001|NCT00299000|B2|Baseline|Naglazyme, 2.0 mg/kg|weekly infusions for minimum of 52 weeks
1200002|NCT00299000|B1|Baseline|Naglazyme, 1.0 mg/kg|weekly infusions for minimum of 52 weeks
1200003|NCT00299000|P2|Participant Flow|Naglazyme, 2.0 mg/kg|weekly infusions for minimum of 52 weeks
1200015|NCT00298766|B1|Baseline|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
1200016|NCT00298766|P1|Participant Flow|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
1200017|NCT00298766|O1|Outcome|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
1200018|NCT00298766|O1|Outcome|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
1200019|NCT00298766|O1|Outcome|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
1200020|NCT00298766|O1|Outcome|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
1200021|NCT00298766|O1|Outcome|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
1200022|NCT00298766|O1|Outcome|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
1200023|NCT00298766|E1|Reported Event|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
1200024|NCT00298610|B1|Baseline|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.~Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
1200025|NCT00298610|P1|Participant Flow|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.~Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
1200026|NCT00298610|O1|Outcome|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.~Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
1200057|NCT00298558|O2|Outcome|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
1200794|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200027|NCT00298610|O1|Outcome|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.~Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
1200028|NCT00298610|O1|Outcome|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.~Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
1200029|NCT00298610|O1|Outcome|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.~Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
1200030|NCT00298610|O1|Outcome|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.~Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
1200031|NCT00298610|O1|Outcome|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.~Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
1200032|NCT00298610|O1|Outcome|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.~Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
1200033|NCT00298610|E1|Reported Event|Artesunate and Malarone|"Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.~Artesunate and Malarone: Intravenous Artesunate (2.4 mg/kg) once a day for three days and Malarone (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)"
1200034|NCT00298558|B5|Baseline|Total|Total of all reporting groups
1200035|NCT00298558|B4|Baseline|Control|This group did not complete any cognitive training interventions
1200036|NCT00298558|B3|Baseline|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
1200037|NCT00298558|B2|Baseline|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
1200120|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200591|NCT00296647|E2|Reported Event|Nicotine Lozenge|
1200038|NCT00298558|B1|Baseline|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
1200039|NCT00298558|P4|Participant Flow|Control|This group did not complete any cognitive training interventions
1200040|NCT00298558|P3|Participant Flow|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
1200041|NCT00298558|P2|Participant Flow|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
1200042|NCT00298558|P1|Participant Flow|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
1200043|NCT00298558|O4|Outcome|Control|This group did not complete any cognitive training interventions
1200044|NCT00298558|O3|Outcome|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
1200045|NCT00298558|O2|Outcome|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
1200046|NCT00298558|O1|Outcome|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
1200047|NCT00298558|O4|Outcome|Control|This group did not complete any cognitive training interventions
1200048|NCT00298558|O3|Outcome|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
1200049|NCT00298558|O2|Outcome|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
1200050|NCT00298558|O1|Outcome|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
1200051|NCT00298558|O4|Outcome|Control|This group did not complete any cognitive training interventions
1200052|NCT00298558|O3|Outcome|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
1200053|NCT00298558|O2|Outcome|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
1200060|NCT00298558|O3|Outcome|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
1200061|NCT00298558|O2|Outcome|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
1200062|NCT00298558|O1|Outcome|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
1200063|NCT00298558|O4|Outcome|Control|This group did not complete any cognitive training interventions
1200064|NCT00298558|O3|Outcome|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
1200065|NCT00298558|O2|Outcome|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
1200066|NCT00298558|O1|Outcome|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
1200067|NCT00298558|E4|Reported Event|Control|This group did not complete any cognitive training interventions
1200068|NCT00298558|E3|Reported Event|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
1200069|NCT00298558|E2|Reported Event|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
1200070|NCT00298558|E1|Reported Event|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
1200071|NCT00298363|B4|Baseline|Total|Total of all reporting groups
1200072|NCT00298363|B3|Baseline|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200073|NCT00298363|B2|Baseline|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200074|NCT00298363|B1|Baseline|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200075|NCT00298363|P3|Participant Flow|Entecavir|Participants in this group were randomized to receive DB ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline, and may have been unblinded (due to either lack of adequate decrease of HBV DNA or virologic breakthrough) and switched to OL FTC/TDF.
1200076|NCT00298363|P2|Participant Flow|FTC/TDF|Participants in this group were randomized to receive DB FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline, and may have been unblinded (due to either lack of adequate decrease of HBV DNA or virologic breakthrough) and switched to OL FTC/TDF.
1200077|NCT00298363|P1|Participant Flow|Tenofovir DF|Participants in this group were randomized to receive double-blind (DB) TDF 300 mg + FTC)/TDF placebo + ETV placebo at baseline, and may have been unblinded (due to either lack of adequate decrease of HBV DNA or virologic breakthrough) and switched to open-label (OL) FTC/TDF (this study enrolled participants with decompensated liver disease, and early intervention strategies were provided if profound viral suppression was not achieved quickly).
1200078|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
1200079|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200080|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200081|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200082|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
1200083|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200084|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200085|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200086|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
1200087|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200088|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200089|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200090|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
1200091|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200092|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200093|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200094|NCT00298363|O4|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200095|NCT00298363|O3|Outcome|TDF or FTC/TDF|Participants in this group include all participants who received TDF or FTC/TDF during the study.
1200439|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
1200098|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200099|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200100|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200101|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200102|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200103|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200104|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200105|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200106|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200107|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
1200108|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200109|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200110|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200111|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
1200112|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200113|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200114|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200115|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
1200116|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200117|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200118|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200119|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
1200121|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200122|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200123|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
1200124|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200125|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200126|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200127|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
1200128|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200129|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200130|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200131|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
1200132|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200133|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200134|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200135|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
1200136|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200137|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200138|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200139|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
1200140|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200141|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200142|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200143|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
1200144|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200145|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200146|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200147|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
1200148|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200149|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200150|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200151|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
1200152|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200153|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200154|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200155|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
1200156|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200157|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200158|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200159|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
1200160|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200161|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200162|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200163|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
1200164|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200165|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200166|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200167|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
1200168|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200169|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200170|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200171|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
1200172|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200173|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200174|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200175|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
1200176|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200177|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200178|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200179|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
1200180|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200181|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200182|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200183|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
1200184|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200185|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200186|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200187|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
1200188|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200189|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200190|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200191|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
1200192|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200193|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200194|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200195|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
1200196|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200197|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200198|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200199|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
1200200|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200201|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200202|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200203|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
1200204|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200205|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200206|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200207|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
1200208|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200209|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200210|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200211|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
1200212|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200213|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200214|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200215|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
1200216|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200217|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200218|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200219|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
1200220|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200221|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200222|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200223|NCT00298363|O4|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
1200224|NCT00298363|O3|Outcome|TDF or FTC/TDF|Participants in this group include all participants who received TDF or FTC/TDF during the study.
1200225|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
1200226|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
1200227|NCT00298363|E5|Reported Event|All TDF|Participants in this group received a TDF-containing treatment (all double-blind TDF, FTC/TDF, or open-label FTC/TDF) during the study.
1200228|NCT00298363|E4|Reported Event|Open Label FTC/TDF|Participants in this group were randomized to receive TDF, FTC/TDF, or ETV at the beginning of the study, but switched to open label FTC/TDF during the study.
1200229|NCT00298363|E3|Reported Event|Double Blind ETV|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo
1200230|NCT00298363|E2|Reported Event|Double Blind FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo
1200231|NCT00298363|E1|Reported Event|Double Blind TDF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo
1200232|NCT00298272|B3|Baseline|Total|Total of all reporting groups
1200246|NCT00298272|O1|Outcome|Rituximab|The rituximab treatment group received rituximab 500 mg by intravenous infusion (IV) on Day 1 and Day 15. Prior to rituximab infusion, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
1200430|NCT00297427|O1|Outcome|Responders|50% or greater reduction in incontinent episodes following true acupuncture
1200233|NCT00298272|B2|Baseline|Double-blind Placebo/Open Label Rituximab|"The double-blind placebo treatment group received saline solution IV on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
1200234|NCT00298272|B1|Baseline|Double-blind/Open Label Rituximab|"The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
1200235|NCT00298272|P2|Participant Flow|Double-blind Placebo/Open Label Rituximab|"The double-blind placebo treatment group received saline solution IV on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
1200236|NCT00298272|P1|Participant Flow|Double-blind/Open Label Rituximab|"The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
1200237|NCT00298272|O2|Outcome|Double-blind Placebo/Open Label Rituximab|"The double-blind placebo treatment group received saline solution IV on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
1200238|NCT00298272|O1|Outcome|Double-blind/Open Label Rituximab|"The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
1200321|NCT00297778|B1|Baseline|Placebo|Placebo tablet matching active treatment
1200592|NCT00296647|E1|Reported Event|Patch|
1200239|NCT00298272|O2|Outcome|Double-blind Placebo/Open Label Rituximab|"The double-blind placebo treatment group received saline solution IV on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
1200240|NCT00298272|O1|Outcome|Double-blind/Open Label Rituximab|"The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
1200241|NCT00298272|O2|Outcome|Double-blind Placebo/Open Label Rituximab|"The double-blind placebo treatment group received saline solution IV on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
1200242|NCT00298272|O1|Outcome|Double-blind/Open Label Rituximab|"The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
1200243|NCT00298272|O2|Outcome|Double-blind Placebo/Open Label Rituximab|"The double-blind placebo treatment group received saline solution IV on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
1200244|NCT00298272|O1|Outcome|Double-blind/Open Label Rituximab|"The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
1200245|NCT00298272|O2|Outcome|Placebo|The placebo treatment group received saline solution IV on Day 1 and Day 15. Prior to each infusion of placebo, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
1200347|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
1200431|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
1200247|NCT00298272|O2|Outcome|Placebo|The placebo treatment group received saline solution IV on Day 1 and Day 15. Prior to each infusion of placebo, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
1200248|NCT00298272|O1|Outcome|Rituximab|The rituximab treatment group received rituximab 500 mg by intravenous infusion (IV) on Day 1 and Day 15. Prior to rituximab infusion, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
1200249|NCT00298272|O2|Outcome|Placebo|The placebo treatment group received saline solution IV on Day 1 and Day 15. Prior to each infusion of placebo, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
1200250|NCT00298272|O1|Outcome|Rituximab|The rituximab treatment group received rituximab 500 mg by intravenous infusion (IV) on Day 1 and Day 15. Prior to rituximab infusion, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
1200251|NCT00298272|O2|Outcome|Placebo|The placebo treatment group received saline solution IV on Day 1 and Day 15. Prior to each infusion of placebo, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
1200252|NCT00298272|O1|Outcome|Rituximab|The rituximab treatment group received rituximab 500 mg by intravenous infusion (IV) on Day 1 and Day 15. Prior to rituximab infusion, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
1200253|NCT00298272|E3|Reported Event|Cumulative Rituximab|The cumulative rituximab treatment group included all participants who received rituximab at any time during the study, including participants who received rituximab in the double-blind period and did not participate in the OL period, those who received placebo in the double-blind period and rituximab in the OL, and those who received rituximab in the double-blind and OL periods. Prior to rituximab infusion, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
1200254|NCT00298272|E2|Reported Event|Double-Blind Placebo|The placebo treatment group received saline solution IV on Day 1 and Day 15. Prior to each infusion of placebo, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
1200255|NCT00298272|E1|Reported Event|Double-Blind Rituximab|The rituximab treatment group received rituximab 500 mg by intravenous infusion (IV) on Day 1 and Day 15. Prior to rituximab infusion, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
1200256|NCT00298233|B3|Baseline|Total|Total of all reporting groups
1200257|NCT00298233|B2|Baseline|Double Dose Oseltamivir|All participants that were randomized and received doubledose oseltamivir
1200258|NCT00298233|B1|Baseline|Standarad Dose Oseltamivir|All participants that were randomized and received standard dose oseltamivir
1200259|NCT00298233|P4|Participant Flow|Double Dose Oseltamivir Child Cohort|All Participants <15 years received high-dose oseltamivir (150 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) for 5 to 10 days.
1200260|NCT00298233|P3|Participant Flow|Standard Dose Oseltamivir Child Cohort|All participants <15 years received standard dose oseltamivir (75 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) for 5 to 10 days.
1200261|NCT00298233|P2|Participant Flow|Double Dose Oseltamivir Adult Cohort|All Participants >= 15 years received high-dose oseltamivir (150 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) for 5 to 10 days.
1200262|NCT00298233|P1|Participant Flow|Standard Dose Oseltamivir Adult Cohort|All participants >= 15 years received standard-dose oseltamivir (75 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) for 5 to 10 days.
1200263|NCT00298233|O2|Outcome|Standard Dose Oseltamivir|All participants receiving standard dose oseltamivir
1200264|NCT00298233|O1|Outcome|Double Dose Oseltamivir|All participants receiving double dose oseltamivir
1200265|NCT00298233|O2|Outcome|Standard Dose Oseltamivir|All participants receiving standard dose oseltamivir
1200266|NCT00298233|O1|Outcome|Double Dose Oseltamivir|All participants receiving double dose oseltamivir
1200267|NCT00298233|O2|Outcome|Standard Dose Oseltamivir|All participants receiving standard dose oseltamivir
1200268|NCT00298233|O1|Outcome|Double Dose Oseltamivir|All participants receiving double dose oseltamivir
1200269|NCT00298233|O2|Outcome|Standard Dose Oseltamivir|All participants receiving standard dose oseltamivir
1200270|NCT00298233|O1|Outcome|Double Dose Oseltamivir|All participants receiving double dose oseltamivir
1200271|NCT00298233|O2|Outcome|Standard Dose Oseltamivir|All participants receiving standard dose oseltamivir
1200272|NCT00298233|O1|Outcome|Double Dose Oseltamivir|All participants receiving double dose oseltamivir
1200273|NCT00298233|O2|Outcome|Standard Dose Oseltamivir|All participants receiving standard dose oseltamivir
1200274|NCT00298233|O1|Outcome|Double Dose Oseltamivir|All participants receiving double dose oseltamivir
1200275|NCT00298233|E2|Reported Event|Standard Dose Oseltamivir|The study recorded only cumulative data (total number of adverse events (AEs) per type, per Arm, but not number of subjects affected per AE type). Therefore data are the number of events and not the number of participants with events.
1200276|NCT00298233|E1|Reported Event|Double Dose Oseltamivir|The study recorded only cumulative data (total number of adverse events (AEs) per type, per Arm, but not number of subjects affected per AE type). Therefore data are the number of events and not the number of participants with events.
1200277|NCT00298155|B4|Baseline|Total|Total of all reporting groups
1200278|NCT00298155|B3|Baseline|Group 3|"Begin bicalutamide for one week, goserelin injection; begin dutasteride, ketoconazole (and replacement hydrocortisone), continue bicalutamide for the full 12 weeks~goserelin with bicalutamide and dutasteride and ketoconazole: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot), begin dutasteride 3.5 mg qd and ketoconazole 200 mg tid (with hydrocortisone 30 mg)."
1200279|NCT00298155|B2|Baseline|Group 2|"Bicalutamide for one week, begin goserelin plus dutasteride, continue bicalutamide for the full 12 weeks~goserelin with bicalutamide and dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd."
1200280|NCT00298155|B1|Baseline|Group 1|"Goserelin + dutasteride~goserelin with dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd; continue bicalutamide for one more week."
1200281|NCT00298155|P3|Participant Flow|Group 3|"Begin bicalutamide for one week, goserelin injection; begin dutasteride, ketoconazole (and replacement hydrocortisone), continue bicalutamide for the full 12 weeks~goserelin with bicalutamide and dutasteride and ketoconazole: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot), begin dutasteride 3.5 mg qd and ketoconazole 200 mg tid (with hydrocortisone 30 mg)."
1200282|NCT00298155|P2|Participant Flow|Group 2|"Bicalutamide for one week, begin goserelin plus dutasteride, continue bicalutamide for the full 12 weeks~goserelin with bicalutamide and dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd."
1200283|NCT00298155|P1|Participant Flow|Group 1|"Goserelin + dutasteride~goserelin with dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd; continue bicalutamide for one more week."
1200284|NCT00298155|O3|Outcome|Group 3|"Begin bicalutamide for one week, goserelin injection; begin dutasteride, ketoconazole (and replacement hydrocortisone), continue bicalutamide for the full 12 weeks~goserelin with bicalutamide and dutasteride and ketoconazole: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot), begin dutasteride 3.5 mg qd and ketoconazole 200 mg tid (with hydrocortisone 30 mg)."
1200285|NCT00298155|O2|Outcome|Group 2|"Bicalutamide for one week, begin goserelin plus dutasteride, continue bicalutamide for the full 12 weeks~goserelin with bicalutamide and dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd."
1200286|NCT00298155|O1|Outcome|Group 1|"Goserelin + dutasteride~goserelin with dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd; continue bicalutamide for one more week."
1200287|NCT00298155|O3|Outcome|Group 3|"Begin bicalutamide for one week, goserelin injection; begin dutasteride, ketoconazole (and replacement hydrocortisone), continue bicalutamide for the full 12 weeks~goserelin with bicalutamide and dutasteride and ketoconazole: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot), begin dutasteride 3.5 mg qd and ketoconazole 200 mg tid (with hydrocortisone 30 mg)."
1200288|NCT00298155|O2|Outcome|Group 2|"Bicalutamide for one week, begin goserelin plus dutasteride, continue bicalutamide for the full 12 weeks~goserelin with bicalutamide and dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd."
1200289|NCT00298155|O1|Outcome|Group 1|"Goserelin + dutasteride~goserelin with dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd; continue bicalutamide for one more week."
1200322|NCT00297778|P2|Participant Flow|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
1200593|NCT00296517|B3|Baseline|Total|Total of all reporting groups
1200290|NCT00298155|E3|Reported Event|Group 3|"Begin bicalutamide for one week, goserelin injection; begin dutasteride, ketoconazole (and replacement hydrocortisone), continue bicalutamide for the full 12 weeks~goserelin with bicalutamide and dutasteride and ketoconazole: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot), begin dutasteride 3.5 mg qd and ketoconazole 200 mg tid (with hydrocortisone 30 mg)."
1200291|NCT00298155|E2|Reported Event|Group 2|"Bicalutamide for one week, begin goserelin plus dutasteride, continue bicalutamide for the full 12 weeks~goserelin with bicalutamide and dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd."
1200292|NCT00298155|E1|Reported Event|Group 1|"Goserelin + dutasteride~goserelin with dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd; continue bicalutamide for one more week."
1200293|NCT00298090|B1|Baseline|StO2 Values|StO2 values pre and post arterial line placement.
1200294|NCT00298090|P1|Participant Flow|StO2 Values Pre and Post Arterial Line Placement|single arm study of StO2 in subjects undergoing placement of arterial line. Measurements of StO2 will be taken before and after arterial line placement.
1200295|NCT00298090|O1|Outcome|StO2 Values|StO2 pre and post catheter placement
1200296|NCT00298090|E1|Reported Event|StO2|StO2 measurements pre and post arterial line catheter placement.
1200297|NCT00297830|B4|Baseline|Total|Total of all reporting groups
1200298|NCT00297830|B3|Baseline|Reference Group|The reference group included concurrently transplanted patients with T scores of -1.5 or greater.
1200299|NCT00297830|B2|Baseline|Placebo Infusion and Active Alendronate|Group 2 will receive an infusion of placebo during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.
1200300|NCT00297830|B1|Baseline|Active Zoledronic Acid and Placebo Alendronate|Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion.
1200301|NCT00297830|P3|Participant Flow|Reference Group|The reference group included concurrently transplanted patients with T scores of -1.5 or greater.
1200302|NCT00297830|P2|Participant Flow|Placebo Zoledronic Acid and Active Alendronate|Group 2 will receive an infusion of placebo during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.
1200303|NCT00297830|P1|Participant Flow|Active Zoledronic Acid and Placebo Alendronate|Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion.
1200304|NCT00297830|O3|Outcome|Reference Group|The reference group included concurrently transplanted patients with T scores of -1.5 or greater.
1200305|NCT00297830|O2|Outcome|Placebo Zoledronic Acid and Active Alendronate|Group 2 will receive an infusion of placebo during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.
1200306|NCT00297830|O1|Outcome|Active Zoledronic Acid and Placebo Alendronate|Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion.
1200307|NCT00297830|O3|Outcome|Reference Group|The reference group included concurrently transplanted patients with T scores of -1.5 or greater.
1200422|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
1200423|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
1200308|NCT00297830|O2|Outcome|Placebo Zoledronic Acid and Active Alendronate|Group 2 will receive an infusion of placebo during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.
1200309|NCT00297830|O1|Outcome|Active Zoledronic Acid and Placebo Alendronate|Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion.
1200310|NCT00297830|O3|Outcome|Reference Group|The reference group included concurrently transplanted patients with T scores of -1.5 or greater.
1200311|NCT00297830|O2|Outcome|Placebo Zoledronic Acid and Active Alendronate|Group 2 will receive an infusion of placebo during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.
1200312|NCT00297830|O1|Outcome|Active Zoledronic Acid and Placebo Alendronate|Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion.
1200313|NCT00297830|O3|Outcome|Reference Group|The reference group included concurrently transplanted patients with T scores of -1.5 or greater.
1200314|NCT00297830|O2|Outcome|Placebo Zoledronic Acid and Active Alendronate|Group 2 will receive an infusion of placebo during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.
1200315|NCT00297830|O1|Outcome|Active Zoledronic Acid and Placebo Alendronate|Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion.
1200316|NCT00297830|E3|Reported Event|Reference Group|The reference group included concurrently transplanted patients with T scores of -1.5 or greater.
1200317|NCT00297830|E2|Reported Event|Placebo Infusion and Active Alendronate|Group 2 will receive an infusion of placebo during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.https://register.clinicaltrials.gov/prs/html/results_definitions.html#Result_ParticipantFlow_Period_title
1200318|NCT00297830|E1|Reported Event|Active Zoledronic Acid and Placebo Alendronate|Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion.
1200319|NCT00297778|B3|Baseline|Total|Total of all reporting groups
1200320|NCT00297778|B2|Baseline|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
1200324|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
1200325|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
1200326|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
1200327|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
1200328|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
1200329|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
1200330|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
1200331|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
1200332|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
1200333|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
1200334|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
1200335|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
1200336|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
1200337|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
1200338|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
1200339|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
1200340|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
1200341|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
1200342|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
1200343|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
1200344|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
1200345|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
1200346|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
1200348|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
1200349|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
1200350|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
1200351|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
1200352|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
1200353|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
1200354|NCT00297778|E2|Reported Event|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
1200355|NCT00297778|E1|Reported Event|Placebo|Placebo tablet matching active treatment
1200356|NCT00297648|B1|Baseline|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200357|NCT00297648|P1|Participant Flow|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200358|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200359|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200462|NCT00297258|O4|Outcome|Pazopanib 800mg - Other Soft Tissue Sarcoma (STS)|Pazopanib 800 mg (tablets) administered orally once a day
1200360|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200361|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200362|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200363|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200364|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200365|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200366|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200424|NCT00297427|O1|Outcome|Acupuncture|True acupuncture twice a week for 6 weeks
1200367|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200368|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200369|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200370|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200371|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200372|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200463|NCT00297258|O3|Outcome|Pazopanib 800 mg - Synovial Sarcoma|Pazopanib 800 mg (tablets) administered orally once a day
1200464|NCT00297258|O2|Outcome|Pazopanib 800 mg - Leiomyosarcoma|Pazopanib 800 mg (tablets) administered orally once a day
1200373|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200374|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200375|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200376|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200377|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200378|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200379|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200425|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture twice a week for 6 weeks
1200426|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: True acupuncture twice weekly for 6 weeks
1200427|NCT00297427|O2|Outcome|Non-responders|Less than a 50% reduction in incontinent episodes following true acupuncture
1200380|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200381|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200382|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200383|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200384|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200385|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200386|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200387|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200388|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200389|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200390|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200391|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200392|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200428|NCT00297427|O1|Outcome|Responders|50% or greater reduction in incontinent episodes following true acupuncture
1200429|NCT00297427|O2|Outcome|Non-responders|Less than a 50% reduction in incontinent episodes following true acupuncture
1200795|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200393|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200394|NCT00297648|E1|Reported Event|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
1200395|NCT00297596|B1|Baseline|Oxaliplatin/Trastuzumab|Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. Oxaliplatin : Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab Trastuzumab : Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.
1200396|NCT00297596|P1|Participant Flow|Oxaliplatin/Trastuzumab|Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. Oxaliplatin : Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab Trastuzumab : Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.
1200465|NCT00297258|O1|Outcome|Pazopanib 800 mg - Adipocytic Tumors|Pazopanib 800 mg (tablets) administered orally once a day
1200466|NCT00297258|O4|Outcome|Pazopanib 800mg - Other Soft Tissue Sarcoma (STS)|Pazopanib 800 mg (tablets) administered orally once a day
1200467|NCT00297258|O3|Outcome|Pazopanib 800 mg - Synovial Sarcoma|Pazopanib 800 mg (tablets) administered orally once a day
1200468|NCT00297258|O2|Outcome|Pazopanib 800 mg - Leiomyosarcoma|Pazopanib 800 mg (tablets) administered orally once a day
1200397|NCT00297596|O1|Outcome|Oxaliplatin/Trastuzumab|Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. Oxaliplatin : Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab Trastuzumab : Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.
1200398|NCT00297596|E1|Reported Event|Oxaliplatin/Trastuzumab|Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. Oxaliplatin : Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab Trastuzumab : Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.
1200399|NCT00297492|B4|Baseline|Total|Total of all reporting groups
1200400|NCT00297492|B3|Baseline|Minimal Intervention|Minimal intervention to mimic intervention at a primary care office
1200401|NCT00297492|B2|Baseline|Abrupt Cessation|Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date
1200402|NCT00297492|B1|Baseline|Gradual Reduction|Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date
1200403|NCT00297492|P3|Participant Flow|Minimal Intervention|Minimal intervention to mimic intervention at a primary care office
1200404|NCT00297492|P2|Participant Flow|Abrupt Cessation|Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date
1200405|NCT00297492|P1|Participant Flow|Gradual Reduction|Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date
1200406|NCT00297492|O3|Outcome|Minimal Intervention|Minimal intervention to mimic intervention at a primary care office; nicotine lozenges were provided for use starting on the quit date.
1200407|NCT00297492|O2|Outcome|Abrupt Cessation|Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date; nicotine lozenges were provided for use starting on the quit date.
1200408|NCT00297492|O1|Outcome|Gradual Reduction|Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date; nicotine lozenges were provided to aid reduction prior to the quit date and for use on and following the quit date.
1200409|NCT00297492|E3|Reported Event|Minimal Intervention|Minimal intervention to mimic intervention at a primary care office
1200410|NCT00297492|E2|Reported Event|Abrupt Cessation|Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date
1200411|NCT00297492|E1|Reported Event|Gradual Reduction|Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date
1200412|NCT00297427|B3|Baseline|Total|Total of all reporting groups
1200413|NCT00297427|B2|Baseline|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
1200414|NCT00297427|B1|Baseline|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
1200415|NCT00297427|P2|Participant Flow|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
1200416|NCT00297427|P1|Participant Flow|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
1200417|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
1200418|NCT00297427|O1|Outcome|Acupuncture|True acupuncture twice a week for 6 weeks
1200419|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
1200420|NCT00297427|O1|Outcome|Acupuncture|True acupuncture twice a week for 6 weeks
1200421|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
1200440|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
1200441|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
1200442|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
1200443|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
1200444|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture twice weekly for 6 weeks
1200445|NCT00297427|O1|Outcome|True Acupuncture|True Acupuncture twice weekly for 6 weeks.
1200446|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
1200447|NCT00297427|O1|Outcome|Acupuncture|Ture acupuncture twice a week for 6 weeks
1200448|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
1200449|NCT00297427|O1|Outcome|Acupuncture|True acupuncture twice a week for 6 weeks
1200450|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
1200451|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
1200452|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
1200453|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
1200454|NCT00297427|E2|Reported Event|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
1200455|NCT00297427|E1|Reported Event|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
1200456|NCT00297258|B1|Baseline|Pazopanib 800 mg|Pazopanib 800 milligram (mg) (tablets) administered orally once a day
1200457|NCT00297258|P1|Participant Flow|Pazopanib 800 mg|Pazopanib 800 milligram (mg) (tablets) administered orally once a day
1200458|NCT00297258|O4|Outcome|Pazopanib 800mg - Other Soft Tissue Sarcoma (STS)|Pazopanib 800 mg (tablets) administered orally once a day
1200459|NCT00297258|O3|Outcome|Pazopanib 800 mg - Synovial Sarcoma|Pazopanib 800 mg (tablets) administered orally once a day
1200460|NCT00297258|O2|Outcome|Pazopanib 800 mg - Leiomyosarcoma|Pazopanib 800 mg (tablets) administered orally once a day
1200461|NCT00297258|O1|Outcome|Pazopanib 800 mg - Adipocytic Tumors|Pazopanib 800 mg (tablets) administered orally once a day
1200584|NCT00296647|O4|Outcome|Patch + Lozenge|
1200469|NCT00297258|O1|Outcome|Pazopanib 800 mg - Adipocytic Tumors|Pazopanib 800 mg (tablets) administered orally once a day
1200470|NCT00297258|O4|Outcome|Pazopanib 800mg - Other Soft Tissue Sarcoma (STS)|Pazopanib 800 mg (tablets) administered orally once a day
1200471|NCT00297258|O3|Outcome|Pazopanib 800 mg - Synovial Sarcoma|Pazopanib 800 mg (tablets) administered orally once a day
1200472|NCT00297258|O2|Outcome|Pazopanib 800 mg - Leiomyosarcoma|Pazopanib 800 mg (tablets) administered orally once a day
1200473|NCT00297258|O1|Outcome|Pazopanib 800 mg - Adipocytic Tumors|Pazopanib 800 mg (tablets) administered orally once a day
1200474|NCT00297258|E1|Reported Event|Pazopanib 800 mg|Pazopanib 800 milligram (mg) (tablets) administered orally once a day
1200475|NCT00297232|B1|Baseline|Natalizumab|300 mg IV infusions once every 4 weeks for up to 480 weeks
1200476|NCT00297232|P1|Participant Flow|Natalizumab|300 mg intravenous (IV) infusions once every 4 weeks for up to 480 weeks
1200477|NCT00297232|O1|Outcome|Natalizumab|300 mg IV infusions once every 4 weeks for up to 480 weeks
1200478|NCT00297232|O1|Outcome|Natalizumab|300 mg IV infusions once every 4 weeks for up to 480 weeks
1200479|NCT00297232|O1|Outcome|Natalizumab|300 mg IV infusions once every 4 weeks for up to 480 weeks
1200480|NCT00297232|E1|Reported Event|Natalizumab|300 mg IV infusions once every 4 weeks for up to 480 weeks
1200481|NCT00297167|B1|Baseline|Entire Study Population|Includes participants who received EUR-1008 (APT-1008) in open-label dose titration and stabilization phase; and EUR-1008 (APT-1008) first and placebo first after randomization to study treatment.
1200482|NCT00297167|P3|Participant Flow|EUR-1008 (APT-1008) (Open-label)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily at a fixed stabilized dose during open-label normalization period 1 (5 to 14 days) after first double-blind interventional period and during open-label normalization period 2 (7 days) after second double-blind interventional period.
1200483|NCT00297167|P2|Participant Flow|EUR-1008 (APT-1008) First, Then Placebo|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first double-blind intervention period followed by placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
1200497|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
1200530|NCT00297102|P1|Participant Flow|Roflumilast|500 mcg, once daily, oral administration in the morning
1200531|NCT00297102|O2|Outcome|Placebo|once daily
1200484|NCT00297167|P1|Participant Flow|Placebo First, Then EUR-1008 (APT-1008)|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first double-blind intervention period followed by EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units per kilogram body weight per day (lipase units/kg/day).
1200485|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
1200486|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
1200487|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
1200488|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
1200489|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
1200585|NCT00296647|O3|Outcome|Bupropion|
1200586|NCT00296647|O2|Outcome|Lozenge|
1200490|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
1200491|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
1200492|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
1200493|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
1200494|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
1200495|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
1200496|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
1200498|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
1200499|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
1200500|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
1200501|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
1200502|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
1200503|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
1200587|NCT00296647|O1|Outcome|Patch|
1200588|NCT00296647|E5|Reported Event|Buproion + Lozenge|
1200589|NCT00296647|E4|Reported Event|Patch + Lozenge|
1200504|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
1200505|NCT00297167|E2|Reported Event|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule was given orally daily in the first and second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
1200506|NCT00297167|E1|Reported Event|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule was given orally daily in the first and second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. Participants received EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule was given orally daily at a fixed stabilized dose for 5 to 14 days during open-label dose normalization period 1 and for 7 days during open-label dose normalization period 2 which was maintained after each double-blind intervention period. The stabilized dose was not to exceed 10,000 lipase units per kilogram body weight per day (units/kg/day).
1200507|NCT00297115|B3|Baseline|Total|Total of all reporting groups
1200508|NCT00297115|B2|Baseline|Placebo|once daily
1200509|NCT00297115|B1|Baseline|Roflumilast|500 mcg, once daily, oral administration in the morning
1200510|NCT00297115|P2|Participant Flow|Placebo|once daily
1200511|NCT00297115|P1|Participant Flow|Roflumilast|500 mcg, once daily, oral administration in the morning
1200512|NCT00297115|O2|Outcome|Placebo|once daily
1200513|NCT00297115|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
1200514|NCT00297115|O2|Outcome|Placebo|once daily
1200515|NCT00297115|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
1200516|NCT00297115|O2|Outcome|Placebo|once daily
1200517|NCT00297115|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
1200518|NCT00297115|O2|Outcome|Placebo|once daily
1200519|NCT00297115|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
1200520|NCT00297115|O2|Outcome|Placebo|once daily
1200521|NCT00297115|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
1200522|NCT00297115|O2|Outcome|Placebo|once daily
1200523|NCT00297115|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
1200524|NCT00297115|E2|Reported Event|Placebo|once daily
1200525|NCT00297115|E1|Reported Event|Roflumilast|500 mcg, once daily, oral administration in the morning
1200526|NCT00297102|B3|Baseline|Total|Total of all reporting groups
1200527|NCT00297102|B2|Baseline|Placebo|once daily
1200528|NCT00297102|B1|Baseline|Roflumilast|500 mcg, once daily, oral administration in the morning
1200532|NCT00297102|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
1200533|NCT00297102|O2|Outcome|Placebo|once daily
1200534|NCT00297102|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
1200535|NCT00297102|O2|Outcome|Placebo|once daily
1200536|NCT00297102|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
1200537|NCT00297102|O2|Outcome|Placebo|once daily
1200538|NCT00297102|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
1200539|NCT00297102|O2|Outcome|Placebo|once daily
1200540|NCT00297102|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
1200541|NCT00297102|O2|Outcome|Placebo|once daily
1200542|NCT00297102|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
1200543|NCT00297102|E2|Reported Event|Placebo|once daily
1200544|NCT00297102|E1|Reported Event|Roflumilast|500 mcg, once daily, oral administration in the morning
1200545|NCT00297037|B3|Baseline|Total|Total of all reporting groups
1200546|NCT00297037|B2|Baseline|Vehicle Cream|0.25 grams of vehicle cream (identical in composition and appearance to pimecrolimus 1% cream without active product) applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes
1200547|NCT00297037|B1|Baseline|Pimecrolimus 1% Cream|0.25 grams of pimecrolimus 1% cream applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes
1200548|NCT00297037|P2|Participant Flow|Vehicle Cream|0.25 grams of vehicle cream (identical in composition and appearance to pimecrolimus 1% cream without active product) applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes
1200549|NCT00297037|P1|Participant Flow|Pimecrolimus 1% Cream|0.25 grams of pimecrolimus 1% cream applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes
1200550|NCT00297037|O2|Outcome|Vehicle|During the 6 week double blind phase all patients were randomly assigned to receive either pimecrolimus 1% cream or vehicle twice daily with occlusion on the affected areas.
1200551|NCT00297037|O1|Outcome|Pimecrolimus Cream|During the 6 week double blind phase all patients were randomly assigned to receive either pimecrolimus 1% cream or vehicle twice daily with occlusion on the affected areas.
1200552|NCT00297037|O2|Outcome|Vehicle Cream|"During the 6-week double-blind phase, all patients will be randomly assigned to receive either pimecrolimus 1% cream or its vehicle twice daily with occlusion on the affected areas. Topical application of pimecrolimus1% cream for oral erosive lichen planus for a duration of 6 weeks; ¼ gram of cream will be applied to each of the 2 sides of the mouth BID with a 2x2 gauze."
1200553|NCT00297037|O1|Outcome|Pimecrolimus Cream|"During the 6-week double-blind phase, all patients will be randomly assigned to receive either pimecrolimus 1% cream or its vehicle twice daily with occlusion on the affected areas. Topical application of pimecrolimus1% cream for oral erosive lichen planus for a duration of 6 weeks; ¼ gram of cream will be applied to each of the 2 sides of the mouth BID with a 2x2 gauze."
1200554|NCT00297037|O2|Outcome|Vehicle Cream|"During the 6-week double-blind phase, all patients will be randomly assigned to receive either pimecrolimus 1% cream or its vehicle twice daily with occlusion on the affected areas. Topical application of pimecrolimus1% cream for oral erosive lichen planus for a duration of 6 weeks; ¼ gram of cream will be applied to each of the 2 sides of the mouth BID with a 2x2 gauze."
1200555|NCT00297037|O1|Outcome|Pimecrolimus Cream|"During the 6-week double-blind phase, all patients will be randomly assigned to receive either pimecrolimus 1% cream or its vehicle twice daily with occlusion on the affected areas. Topical application of pimecrolimus1% cream for oral erosive lichen planus for a duration of 6 weeks; ¼ gram of cream will be applied to each of the 2 sides of the mouth BID with a 2x2 gauze."
1200556|NCT00297037|E2|Reported Event|Vehicle Cream|0.25 grams of vehicle cream (identical in composition and appearance to pimecrolimus 1% cream without active product) applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes
1200557|NCT00297037|E1|Reported Event|Pimecrolimus 1% Cream|0.25 grams of pimecrolimus 1% cream applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes
1200558|NCT00296816|B3|Baseline|Total|Total of all reporting groups
1200559|NCT00296816|B2|Baseline|Oxaliplatin/Docetaxel/Bevacizumab (Non-Measurable Disease)|"Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery, who did not have a measurable disease at baseline.~Measurable disease was defined as having at least one lesion that could be accurately measured in at least one dimension."
1200560|NCT00296816|B1|Baseline|Oxaliplatin/Docetaxel/Bevacizumab (Measurable Disease)|"Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery, with a measurable disease at baseline.~Measurable disease was defined as having at least one lesion that could be accurately measured in at least one dimension."
1200561|NCT00296816|P1|Participant Flow|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
1200562|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
1200563|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
1200605|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
1200796|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200564|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
1200565|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
1200566|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
1200567|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
1200568|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
1200569|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
1200570|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
1200571|NCT00296816|E1|Reported Event|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
1200572|NCT00296647|B6|Baseline|Total|Total of all reporting groups
1200573|NCT00296647|B5|Baseline|Buproion + Lozenge|
1200574|NCT00296647|B4|Baseline|Patch + Lozenge|
1200575|NCT00296647|B3|Baseline|Bupropion|
1200576|NCT00296647|B2|Baseline|Nicotine Lozenge|
1200577|NCT00296647|B1|Baseline|Patch|
1200578|NCT00296647|P5|Participant Flow|Buproion + Lozenge|
1200579|NCT00296647|P4|Participant Flow|Patch + Lozenge|
1200580|NCT00296647|P3|Participant Flow|Bupropion|
1200581|NCT00296647|P2|Participant Flow|Nicotine Lozenge|
1200582|NCT00296647|P1|Participant Flow|Patch|
1200583|NCT00296647|O5|Outcome|Buproion + Lozenge|
1200594|NCT00296517|B2|Baseline|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
1200595|NCT00296517|B1|Baseline|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
1200596|NCT00296517|P2|Participant Flow|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
1200597|NCT00296517|P1|Participant Flow|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
1200598|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
1200599|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
1200600|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
1200601|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
1200602|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
1200603|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
1200604|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
1200606|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
1200607|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
1200608|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
1200609|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
1200610|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
1200611|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
1200612|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
1200613|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
1200614|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
1200615|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
1200616|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
1200617|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
1200618|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
1200619|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
1200620|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
1200621|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
1200622|NCT00296517|E2|Reported Event|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
1200623|NCT00296517|E1|Reported Event|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
1200624|NCT00296504|B9|Baseline|Total|Total of all reporting groups
1200625|NCT00296504|B8|Baseline|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
1200626|NCT00296504|B7|Baseline|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
1200627|NCT00296504|B6|Baseline|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
1200628|NCT00296504|B5|Baseline|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
1200629|NCT00296504|B4|Baseline|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
1200630|NCT00296504|B3|Baseline|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
1200631|NCT00296504|B2|Baseline|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
1200632|NCT00296504|B1|Baseline|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
1200633|NCT00296504|P9|Participant Flow|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
1200634|NCT00296504|P8|Participant Flow|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
1200635|NCT00296504|P7|Participant Flow|Protease Inhibitor (PI)-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
1200787|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200636|NCT00296504|P6|Participant Flow|FPV/RTV Twice Daily (BID) Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
1200637|NCT00296504|P5|Participant Flow|FPV/RTV Once Daily (QD) Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
1200638|NCT00296504|P4|Participant Flow|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
1200639|NCT00296504|P3|Participant Flow|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
1200640|NCT00296504|P2|Participant Flow|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received nelfinavir (NFV) in APV30001
1200641|NCT00296504|P1|Participant Flow|FPV Population (APV30001)|Fosamprenavir (FPV) +/- ritonavir (RTV) + background regimen in participants who had received FPV in APV30001 (NCT00008554)
1200642|NCT00296504|O4|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
1200643|NCT00296504|O3|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
1200644|NCT00296504|O2|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
1200645|NCT00296504|O1|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
1200646|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
1200647|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
1200648|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
1200649|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
1200650|NCT00296504|O8|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
1200651|NCT00296504|O7|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
1200652|NCT00296504|O6|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
1200653|NCT00296504|O5|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
1200654|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
1200655|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
1200656|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
1200657|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
1200658|NCT00296504|O1|Outcome|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
1200753|NCT00296491|O1|Outcome|Fluticasone Prop/Salmeterol/Montelukast (FSC+MON)|
1200754|NCT00296491|O2|Outcome|Fluticasone Propionate/Salmeterol (FSC)|
1200659|NCT00296504|O4|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
1200660|NCT00296504|O3|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
1200661|NCT00296504|O2|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
1200662|NCT00296504|O1|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
1200663|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
1200664|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
1200665|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
1200666|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
1200667|NCT00296504|O4|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
1200668|NCT00296504|O3|Outcome|PI-Naïve Population (Other Studies)|FFPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
1200669|NCT00296504|O2|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
1200670|NCT00296504|O1|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
1200671|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
1200672|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
1200673|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
1200674|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
1200675|NCT00296504|O1|Outcome|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
1200676|NCT00296504|O4|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
1200677|NCT00296504|O3|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
1200678|NCT00296504|O2|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
1200679|NCT00296504|O1|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
1200680|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
1200681|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
1200682|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
1200683|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
1200684|NCT00296504|O1|Outcome|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
1200685|NCT00296504|O4|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
1200686|NCT00296504|O3|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
1200687|NCT00296504|O2|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
1200688|NCT00296504|O1|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
1200689|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
1200690|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
1200691|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
1200692|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
1200693|NCT00296504|O1|Outcome|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
1200694|NCT00296504|O4|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
1200695|NCT00296504|O3|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
1200696|NCT00296504|O2|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
1200697|NCT00296504|O1|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
1200698|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
1200699|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
1200700|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
1200701|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
1200702|NCT00296504|O1|Outcome|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
1200703|NCT00296504|O8|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
1200704|NCT00296504|O7|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
1200705|NCT00296504|O6|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
1200706|NCT00296504|O5|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
1200707|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
1200708|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
1200709|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
1200710|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
1200711|NCT00296504|O1|Outcome|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
1200712|NCT00296504|O8|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
1200713|NCT00296504|O7|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
1200714|NCT00296504|O6|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
1200715|NCT00296504|O5|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
1200716|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
1200717|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
1200718|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
1200719|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
1200720|NCT00296504|E9|Reported Event|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
1200721|NCT00296504|E8|Reported Event|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
1200788|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200789|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200722|NCT00296504|E7|Reported Event|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
1200723|NCT00296504|E6|Reported Event|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
1200724|NCT00296504|E5|Reported Event|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
1200725|NCT00296504|E4|Reported Event|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
1200726|NCT00296504|E3|Reported Event|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
1200727|NCT00296504|E2|Reported Event|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
1200728|NCT00296504|E1|Reported Event|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
1200729|NCT00296491|B5|Baseline|Total|Total of all reporting groups
1200730|NCT00296491|B4|Baseline|Montelukast (MON)|Montelukast (MON) = Placebo DISKUS BID, plus vehicle placebo nasal spray once a day (QD), plus MON (once a day) QD.
1200731|NCT00296491|B3|Baseline|Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)|Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS) = FSC twice a day (BID), plus FPANS (once a day) QD, plus placebo capsule once a day (QD).
1200732|NCT00296491|B2|Baseline|Fluticasone Propionate/Salmeterol (FSC)|Fluticasone Propionate/Salmeterol (FSC) = FSC BID, plus vehicle placebo nasal spray once a day (QD), plus placebo capsule once a day (QD).
1200733|NCT00296491|B1|Baseline|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON) = FSC twice a day (BID), plus vehicle placebo nasal spray once a day (QD), plus MON once a day (QD)
1200734|NCT00296491|P4|Participant Flow|Montelukast (MON)|
1200735|NCT00296491|P3|Participant Flow|Fluticasone Propionate/Salmeterol (FSC)|
1200736|NCT00296491|P2|Participant Flow|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)|
1200737|NCT00296491|P1|Participant Flow|Flut Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)|Flut Prop = Fluticasone Propionate.
1200738|NCT00296491|O2|Outcome|Fluticasone Propionate/Salmeterol (FSC)|
1200739|NCT00296491|O1|Outcome|Fluticasone Propionate + Salmeterol & Montelukast (FSC+MON)|
1200740|NCT00296491|O2|Outcome|Montelukast (MON)|
1200741|NCT00296491|O1|Outcome|Fluticasone Propionate/Salmeterol (FSC)|
1200742|NCT00296491|O2|Outcome|Fluticasone Propionate/Salmeterol (FSC)|
1200743|NCT00296491|O1|Outcome|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)|
1200744|NCT00296491|O2|Outcome|Montelukast (MON)|
1200745|NCT00296491|O1|Outcome|Fluticasone Propionate/Salmeterol (FSC)|
1200746|NCT00296491|O2|Outcome|Fluticasone Propionate/Salmeterol (FSC)|
1200747|NCT00296491|O1|Outcome|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)|
1200748|NCT00296491|O2|Outcome|Montelukast (MON)|
1200749|NCT00296491|O1|Outcome|Fluticasone Propionate/Salmeterol (FSC)|
1200750|NCT00296491|O2|Outcome|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)|
1200751|NCT00296491|O1|Outcome|Flut Prop/Salmeterol/Flut Nasal Spray (FSC+FPANS)|
1200752|NCT00296491|O2|Outcome|Fluticasone Prop/Salmeterol/Flut Nasal Spray (FSC+FPANS)|
1200755|NCT00296491|O1|Outcome|Flut Prop/Salmeterol/Montelukast (FSC+MON)|
1200756|NCT00296491|O2|Outcome|Montelukast (MON)|
1200757|NCT00296491|O1|Outcome|Fluticasone Prop/Salmeterol (FSC)|
1200758|NCT00296491|E4|Reported Event|Montelukast (MON)|Montelukast (MON) = Placebo DISKUS BID, plus vehicle placebo nasal spray once a day (QD), plus MON (once a day) QD.
1200759|NCT00296491|E3|Reported Event|Fluticasone Propionate/Salmeterol (FSC)|Fluticasone Propionate/Salmeterol (FSC) = FSC BID, plus vehicle placebo nasal spray once a day (QD), plus placebo capsule once a day (QD).
1200760|NCT00296491|E2|Reported Event|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON) = FSC twice a day (BID), plus vehicle placebo nasal spray once a day (QD), plus MON once a day (QD)
1200761|NCT00296491|E1|Reported Event|Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)|Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS) = FSC twice a day (BID), plus FPANS (once a day) QD, plus placebo capsule once a day (QD).
1200762|NCT00296400|B4|Baseline|Total|Total of all reporting groups
1200763|NCT00296400|B3|Baseline|Atorvastatin 80 mg|
1200764|NCT00296400|B2|Baseline|Rosuvastatin 40 mg|
1200765|NCT00296400|B1|Baseline|Rosuvastatin 10 mg|
1200766|NCT00296400|P3|Participant Flow|Atorvastatin 80 mg|
1200767|NCT00296400|P2|Participant Flow|Rosuvastatin 40 mg|
1200768|NCT00296400|P1|Participant Flow|Rosuvastatin 10 mg|
1200769|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200770|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200771|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200772|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200773|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200774|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200775|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200776|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200777|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200778|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200779|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200780|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200781|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200782|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200783|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200784|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200785|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200786|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200797|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200798|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200799|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200800|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200801|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200802|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200803|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200804|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200805|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200806|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200807|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200808|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200809|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200810|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200811|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200812|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200813|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200814|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200815|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200816|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200817|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200818|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200819|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200820|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200821|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200822|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200823|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200824|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200825|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200826|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200827|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200828|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200829|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200830|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200831|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200832|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200833|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200834|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200835|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200836|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200837|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200838|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200839|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200840|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200841|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200842|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200843|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200844|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200845|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200846|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200847|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200848|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200849|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200850|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200851|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200852|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200853|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200854|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200855|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200856|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200857|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200858|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200859|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200860|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200861|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200862|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200863|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200864|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200865|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200866|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200867|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200868|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200869|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200870|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200871|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200872|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200873|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200874|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200875|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200876|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200877|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200878|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200879|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200880|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200881|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200882|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200883|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200884|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200885|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200886|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200887|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200888|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200889|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200890|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200891|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200892|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200893|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200894|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200895|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200896|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200897|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200898|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200899|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200900|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200901|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200902|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200903|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200904|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200905|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200906|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200907|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200908|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200909|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200910|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200911|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200912|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200913|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200914|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200915|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200916|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200917|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200918|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200919|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200920|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200921|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200922|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200923|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200924|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200925|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200926|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200927|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200928|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200929|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200930|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200931|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200932|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200933|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200934|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200935|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200936|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200937|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200938|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200939|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200940|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200941|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200942|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200943|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200944|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200945|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200946|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200947|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200948|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200949|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200950|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200951|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200952|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200953|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200954|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200955|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200956|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200957|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200958|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200959|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200960|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200961|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200962|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200963|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200964|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
1200965|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200966|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200967|NCT00296400|O3|Outcome|Atorvastatin 80 mg|
1200968|NCT00296400|O2|Outcome|Rosuvastatin 40 mg|
1200969|NCT00296400|O1|Outcome|Rosuvastatin 10 mg|
1200970|NCT00296400|O3|Outcome|Atorvastatin 80 mg|
1200971|NCT00296400|O2|Outcome|Rosuvastatin 40 mg|
1200972|NCT00296400|O1|Outcome|Rosuvastatin 10 mg|
1200973|NCT00296400|O3|Outcome|Atorvastatin 80 mg|
1200974|NCT00296400|O2|Outcome|Rosuvastatin 40 mg|
1200975|NCT00296400|O1|Outcome|Rosuvastatin 10 mg|
1200976|NCT00296400|O3|Outcome|Atorvastatin 80 mg|
1200977|NCT00296400|O2|Outcome|Rosuvastatin 40 mg|
1200978|NCT00296400|O1|Outcome|Rosuvastatin 10 mg|
1200979|NCT00296400|O3|Outcome|Atorvastatin 80 mg|
1200980|NCT00296400|O2|Outcome|Rosuvastatin 40 mg|
1200981|NCT00296400|O1|Outcome|Rosuvastatin 10 mg|
1200982|NCT00296400|O3|Outcome|Atorvastatin 80 mg|
1200983|NCT00296400|O2|Outcome|Rosuvastatin 40 mg|
1200984|NCT00296400|O1|Outcome|Rosuvastatin 10 mg|
1200985|NCT00296400|E3|Reported Event|Atorvastatin 80 mg|
1200986|NCT00296400|E2|Reported Event|Rosuvastatin 40 mg|
1200987|NCT00296400|E1|Reported Event|Rosuvastatin 10 mg|
1200988|NCT00296374|B4|Baseline|Total|Total of all reporting groups
1200989|NCT00296374|B3|Baseline|Atorvastatin 80mg|
1200990|NCT00296374|B2|Baseline|Rosuvastatin 40mg|
1200991|NCT00296374|B1|Baseline|Rosuvastatin 10mg|
1200992|NCT00296374|P3|Participant Flow|Atorvastatin 80mg|
1200993|NCT00296374|P2|Participant Flow|Rosuvastatin 40mg|
1200994|NCT00296374|P1|Participant Flow|Rosuvastatin 10mg|
1200995|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1200996|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1200997|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1200998|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1200999|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201000|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201001|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201002|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201003|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201004|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201005|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201006|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201007|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201008|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201009|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201010|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201011|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201012|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201013|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201014|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201015|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201016|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201017|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201018|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201019|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201020|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201021|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201022|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201023|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201024|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201025|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201026|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201027|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201028|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201029|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201030|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201031|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201032|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201033|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201034|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201035|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201036|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201037|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201038|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201039|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201040|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201041|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201042|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201043|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201044|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201045|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201046|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201047|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201048|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201049|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201050|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201051|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201052|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201053|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201054|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201055|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201056|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201057|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201058|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201059|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201060|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201061|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201062|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201063|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201064|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201065|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201066|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201067|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201068|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201069|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201070|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201071|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201072|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201073|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201074|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201075|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201076|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201077|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201078|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201079|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201080|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201081|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201082|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201083|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201084|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201085|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201086|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201087|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201088|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201089|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201090|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201091|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201092|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201093|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201094|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201095|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201096|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201097|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201098|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201099|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201100|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201101|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201102|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201103|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201104|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201105|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201106|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201107|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201108|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201109|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201110|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201111|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201112|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201113|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201114|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201115|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201116|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201117|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201118|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201119|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201120|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201121|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201122|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201123|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201124|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201125|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201126|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201127|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201128|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201129|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201130|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201131|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201132|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201133|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201134|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201135|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201136|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201137|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201138|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201139|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201140|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201141|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201142|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201143|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201144|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201145|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201146|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201147|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201148|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201149|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201150|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201151|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201152|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201153|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201154|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201155|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201156|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201157|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201158|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201159|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201160|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201161|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201162|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201163|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201164|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201165|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201166|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201167|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201168|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201169|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201170|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201171|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201172|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201173|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201174|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201175|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201176|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201177|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201178|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201179|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201180|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201181|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201182|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201183|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201184|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201185|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201186|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201187|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201188|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201189|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201190|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
1201191|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
1201192|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
1201193|NCT00296374|O3|Outcome|Atorvastatin 80 mg|
1201194|NCT00296374|O2|Outcome|Rosuvastatin 40 mg|
1201195|NCT00296374|O1|Outcome|Rosuvastatin 10 mg|
1201196|NCT00296374|O3|Outcome|Atorvastatin 80mg|
1201197|NCT00296374|O2|Outcome|Rosuvastatin 40mg|
1201198|NCT00296374|O1|Outcome|Rosuvastatin 10mg|
1201199|NCT00296374|O3|Outcome|Atorvastatin 80mg|
1201200|NCT00296374|O2|Outcome|Rosuvastatin 40mg|
1201201|NCT00296374|O1|Outcome|Rosuvastatin 10mg|
1201202|NCT00296374|O3|Outcome|Atorvastatin 80mg|
1201203|NCT00296374|O2|Outcome|Rosuvastatin 40mg|
1201204|NCT00296374|O1|Outcome|Rosuvastatin 10mg|
1201205|NCT00296374|O3|Outcome|Atorvastatin 80mg|
1201206|NCT00296374|O2|Outcome|Rosuvastatin 40mg|
1201207|NCT00296374|O1|Outcome|Rosuvastatin 10mg|
1201208|NCT00296374|O3|Outcome|Atorvastatin 80mg|
1201209|NCT00296374|O2|Outcome|Rosuvastatin 40mg|
1201210|NCT00296374|O1|Outcome|Rosuvastatin 10mg|
1201211|NCT00296374|E3|Reported Event|Atorvastatin 80mg|
1201212|NCT00296374|E2|Reported Event|Rosuvastatin 40mg|
1201213|NCT00296374|E1|Reported Event|Rosuvastatin 10mg|
1201214|NCT00296335|B3|Baseline|Total|Total of all reporting groups
1201215|NCT00296335|B2|Baseline|Mitomycin, Doxifluridine and Cisplatin|Experimental armMitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)
1201216|NCT00296335|B1|Baseline|Mitomycin and Doxifluridine|Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)
1201217|NCT00296335|P2|Participant Flow|Mitomycin, Doxifluridine and Cisplatin|Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)
1201218|NCT00296335|P1|Participant Flow|Mitomycin and Doxifluridine|Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)
1201219|NCT00296335|O2|Outcome|Mitomycin Plus Long-term Fluoropyrimidine and Monthly Cisplati|Experimental arm
1201220|NCT00296335|O1|Outcome|Mitomycin Plus Short-term Fluoropyrimidine|Control arm
1201221|NCT00296335|O2|Outcome|Mitomycin Plus Long-term Fluoropyrimidine and Monthly Cisplati|Experimental arm
1201222|NCT00296335|O1|Outcome|Mitomycin Plus Short-term Fluoropyrimidine|Control arm
1201275|NCT00296192|O5|Outcome|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
1201276|NCT00296192|O4|Outcome|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
1201223|NCT00296335|O2|Outcome|Mitomycin Plus Long-term Fluoropyrimidine and Monthly Cisplati|Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)
1201224|NCT00296335|O1|Outcome|Mitomycin Plus Short-term Fluoropyrimidine|Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)
1201225|NCT00296335|E2|Reported Event|Mitomycin Plus Long-term Fluoropyrimidine and Monthly Cisplati|Experimental arm
1201226|NCT00296335|E1|Reported Event|Mitomycin Plus Short-term Fluoropyrimidine|Control arm
1201227|NCT00296322|B3|Baseline|Total|Total of all reporting groups
1201228|NCT00296322|B2|Baseline|iceMFP|Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
1201229|NCT00296322|B1|Baseline|Mitomycin and Short-term Fluoropyrimidine|Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery)
1201230|NCT00296322|P2|Participant Flow|iceMFP|Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
1201231|NCT00296322|P1|Participant Flow|Mitomycin and Short-term Fluoropyrimidine|Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery)
1201232|NCT00296322|O2|Outcome|iceMFP|Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
1201233|NCT00296322|O1|Outcome|Mitomycin and Short-term Fluoropyrimidine|Mitomycin and short-term flouropyrimidine
1201234|NCT00296322|O2|Outcome|iceMFP|Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
1201235|NCT00296322|O1|Outcome|Mitomycin and Short-term Fluoropyrimidine|Mitomycin and short-term flouropyrimidine
1201236|NCT00296322|O2|Outcome|iceMFP|Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
1201237|NCT00296322|O1|Outcome|Mitomycin and Short-term Fluoropyrimidine|Mitomycin and short-term flouropyrimidine
1201238|NCT00296322|E2|Reported Event|iceMFP|Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
1201239|NCT00296322|E1|Reported Event|Mitomycin and Short-term Fluoropyrimidine|Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery)
1201240|NCT00296244|B3|Baseline|Total|Total of all reporting groups
1201241|NCT00296244|B2|Baseline|Study Group|Study group- basiliximab, tacrolimus, EC-MPA
1201242|NCT00296244|B1|Baseline|Control Group|Control group -basiliximab, tacrolimus, EC-MPA, steroids
1201243|NCT00296244|P2|Participant Flow|Study Group|Study group- basiliximab (Simulect), tacrolimus (Prograf), EC-MPA (Myfortic)
1201244|NCT00296244|P1|Participant Flow|Control Group|Control group- basiliximab (Simulect), tacrolimus (Prograf), EC-MPA (Myfortic)with steroids
1201245|NCT00296244|O2|Outcome|Study Group|Study group - basiliximab, tacrolimus, EC-MPA
1201246|NCT00296244|O1|Outcome|Control Group|Control group- basiliximab, tacrolimus, EC-MPA, steroids
1201247|NCT00296244|O2|Outcome|Study Group|Study group- basiliximab, tacrolimus, EC-MPA
1201248|NCT00296244|O1|Outcome|Control Group|Control group)-basiliximab, tacrolimus, EC-MPA, steroids
1201249|NCT00296244|O2|Outcome|Study Group|Study group- basiliximab, tacrolimus, EC-MPA
1201250|NCT00296244|O1|Outcome|Control Group|Control group)-basiliximab, tacrolimus, EC-MPA, steroids
1201251|NCT00296244|O2|Outcome|Study Group|Study group -basiliximab, tacrolimus, EC-MPA
1201252|NCT00296244|O1|Outcome|Control Group|Control group -basiliximab, tacrolimus, EC-MPA, steroids
1201253|NCT00296244|O2|Outcome|Study Group|Study group- basiliximab, tacrolimus, EC-MPA
1201254|NCT00296244|O1|Outcome|Control Group|Control group -basiliximab, tacrolimus, EC-MPA, steroids
1201255|NCT00296244|O2|Outcome|Study Group|Study group- basiliximab, tacrolimus, EC-MPA
1201256|NCT00296244|O1|Outcome|Control Group|Control group-basiliximab, tacrolimus, EC-MPA, steroids
1201257|NCT00296244|E2|Reported Event|Study Group|Study group- basiliximab, tacrolimus, EC-MPA
1201258|NCT00296244|E1|Reported Event|Control Group|Control group -basiliximab, tacrolimus, EC-MPA, steroids
1201259|NCT00296231|B1|Baseline|Nassal High Frequency Ventilation|Stable infants, born at less than 1501 g birthweight, who were at least 7 days of age and requiring nasal continuous positive airway pressure ventilatory support
1201260|NCT00296231|P1|Participant Flow|Nassal High Frequency Ventilation|Stable infants, born at less than 1501 g birthweight, who were at least 7 days of age and requiring nasal continuous positive airway pressure ventilatory support
1201261|NCT00296231|O1|Outcome|Nassal High Frequency Ventilation|Stable infants, born at less than 1501 g birthweight, who were at least 7 days of age and requiring nasal continuous positive airway pressure ventilatory support
1201262|NCT00296231|O1|Outcome|Nassal High Frequency Ventilation|Stable infants, born at less than 1501 g birthweight, who were at least 7 days of age and requiring nasal continuous positive airway pressure ventilatory support
1201263|NCT00296231|E1|Reported Event|Nassal High Frequency Ventilation|Stable infants, born at less than 1501 g birthweight, who were at least 7 days of age and requiring nasal continuous positive airway pressure ventilatory support
1201264|NCT00296192|B6|Baseline|Total|Total of all reporting groups
1201265|NCT00296192|B5|Baseline|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
1201266|NCT00296192|B4|Baseline|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
1201267|NCT00296192|B3|Baseline|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
1201268|NCT00296192|B2|Baseline|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
1201269|NCT00296192|B1|Baseline|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
1201270|NCT00296192|P5|Participant Flow|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
1201271|NCT00296192|P4|Participant Flow|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
1201272|NCT00296192|P3|Participant Flow|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
1201273|NCT00296192|P2|Participant Flow|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
1201274|NCT00296192|P1|Participant Flow|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
1201277|NCT00296192|O3|Outcome|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
1201278|NCT00296192|O2|Outcome|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
1201279|NCT00296192|O1|Outcome|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
1201280|NCT00296192|O5|Outcome|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
1201281|NCT00296192|O4|Outcome|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
1201282|NCT00296192|O3|Outcome|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
1201283|NCT00296192|O2|Outcome|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
1201284|NCT00296192|O1|Outcome|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
1201285|NCT00296192|O5|Outcome|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
1201286|NCT00296192|O4|Outcome|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
1201287|NCT00296192|O3|Outcome|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
1201288|NCT00296192|O2|Outcome|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
1201289|NCT00296192|O1|Outcome|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
1201290|NCT00296192|O5|Outcome|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
1201291|NCT00296192|O4|Outcome|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
1201292|NCT00296192|O3|Outcome|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
1201293|NCT00296192|O2|Outcome|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
1201294|NCT00296192|O1|Outcome|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
1201295|NCT00296192|O5|Outcome|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
1201296|NCT00296192|O4|Outcome|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
1201297|NCT00296192|O3|Outcome|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
1201298|NCT00296192|O2|Outcome|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
1201299|NCT00296192|O1|Outcome|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
1201300|NCT00296192|E5|Reported Event|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
1201301|NCT00296192|E4|Reported Event|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
1201302|NCT00296192|E3|Reported Event|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
1201303|NCT00296192|E2|Reported Event|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
1201304|NCT00296192|E1|Reported Event|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
1201305|NCT00296036|B3|Baseline|Total|Total of all reporting groups
1201306|NCT00296036|B2|Baseline|Placebo Cream|Patients receive placebo cream applied to palms and soles twice daily on days 1-21.
1201307|NCT00296036|B1|Baseline|Urea/Lactic Acid Cream|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21.
1201308|NCT00296036|P6|Participant Flow|Arm VI: (Placebo)|Patients receive placebo cream applied to palms and soles twice daily on days 1-21.
1201309|NCT00296036|P5|Participant Flow|Arm V: Urea/Lactic Acid|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21.
1201310|NCT00296036|P4|Participant Flow|Arm IV: (Placebo + Placebo)|Patients receive placebo cream and oral placebo.
1201311|NCT00296036|P3|Participant Flow|Arm III: (Placebo +Vit B6)|Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in Arm I
1201312|NCT00296036|P2|Participant Flow|Arm II: (Urea/Lactic Acid + Placebo)|Patients receive topical urea/lactic acid-based cream as in arm I (closed to accrual as of 10/24/2007) and oral placebo once daily on days 1-21.
1201313|NCT00296036|P1|Participant Flow|Arm I: (Urea/Lactic Acid +Vit B6)|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily and oral pyridoxine once daily on days 1-21.
1201314|NCT00296036|O6|Outcome|Arm VI: (Placebo)|Patients receive placebo cream applied to palms and soles twice daily on days 1-21.
1201315|NCT00296036|O5|Outcome|Arm V: Urea/Lactic Acid|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21.
1201316|NCT00296036|O4|Outcome|Arm IV: (Placebo + Placebo)|Patients receive placebo cream as in arm III and oral placebo as in arm II (closed to accrual as of 10/24/2007).
1201317|NCT00296036|O3|Outcome|Arm III: (Placebo +Vit B6)|Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in arm I (closed to accrual as of 10/24/2007).
1201318|NCT00296036|O2|Outcome|Arm II: (Urea/Lactic Acid + Placebo)|"Patients receive topical urea/lactic acid-based cream as in arm I (closed to accrual as of 10/24/2007) and oral placebo once daily on days 1-21.~urea/lactic acid-based topical cream: Applied topically~placebo: Given orally or applied topically"
1201319|NCT00296036|O1|Outcome|Arm I: (Urea/Lactic Acid +Vit B6)|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily and oral pyridoxine once daily on days 1-21.
1201320|NCT00296036|O6|Outcome|Arm VI: (Placebo)|Patients receive placebo cream applied to palms and soles twice daily on days 1-21.
1201321|NCT00296036|O5|Outcome|Arm V: Urea/Lactic Acid|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21.
1201322|NCT00296036|O4|Outcome|Arm IV: (Placebo + Placebo)|Patients receive placebo cream as in arm III and oral placebo as in arm II.
1201323|NCT00296036|O3|Outcome|Arm III: (Placebo +Vit B6)|Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in arm I.
1201324|NCT00296036|O2|Outcome|Arm II: (Urea/Lactic Acid + Placebo)|Patients receive topical urea/lactic acid-based cream as in arm I (closed to accrual as of 10/24/2007) and oral placebo once daily on days 1-21.
1201325|NCT00296036|O1|Outcome|Arm I: (Urea/Lactic Acid +Vit B6)|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily and oral pyridoxine once daily on days 1-21.
1201326|NCT00296036|O6|Outcome|Arm VI: (Placebo)|Patients receive placebo cream applied to palms and soles twice daily on days 1-21.
1201327|NCT00296036|O5|Outcome|Arm V: Urea/Lactic Acid|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21.
1203749|NCT00288704|O2|Outcome|Rilonacept 160 mg|
1201328|NCT00296036|O4|Outcome|Arm IV: (Placebo + Placebo)|Patients receive placebo cream and oral placebo.
1201329|NCT00296036|O3|Outcome|Arm III: (Placebo +Vit B6)|Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in Arm I
1201330|NCT00296036|O2|Outcome|Arm II: (Urea/Lactic Acid + Placebo)|Patients receive topical urea/lactic acid-based cream as in arm I (closed to accrual as of 10/24/2007) and oral placebo once daily on days 1-21.
1201331|NCT00296036|O1|Outcome|Arm I: (Urea/Lactic Acid +Vit B6)|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily and oral pyridoxine once daily on days 1-21.
1201332|NCT00296036|O2|Outcome|Placebo Cream|Patients receive placebo cream applied to palms and soles twice daily.
1201333|NCT00296036|O1|Outcome|Urea/Lactic Acid Cream|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily.
1201334|NCT00296036|O2|Outcome|Placebo Cream|Patients receive placebo cream applied to palms and soles twice daily.
1201335|NCT00296036|O1|Outcome|Urea/Lactic Acid Cream|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily.
1201336|NCT00296036|E2|Reported Event|Placebo Cream|Patients receive placebo cream applied to palms and soles twice daily on days 1-21.
1201337|NCT00296036|E1|Reported Event|Urea/Lactic Acid Cream|Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21.
1201338|NCT00295880|B1|Baseline|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
1201339|NCT00295880|P1|Participant Flow|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
1201340|NCT00295880|O1|Outcome|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
1201341|NCT00295880|O1|Outcome|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
1201342|NCT00295880|O1|Outcome|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
1201343|NCT00295880|O1|Outcome|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
1201344|NCT00295880|O1|Outcome|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
1201345|NCT00295880|O1|Outcome|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
1201346|NCT00295880|O1|Outcome|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
1201347|NCT00295880|O1|Outcome|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
1201348|NCT00295880|E1|Reported Event|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
1201349|NCT00295854|B4|Baseline|Total|Total of all reporting groups
1201396|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
1201397|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
1205610|NCT00282672|O4|Outcome|HGD Radiofrequency Ablation|
1201350|NCT00295854|B3|Baseline|Placebo|Patients received placebo. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
1201351|NCT00295854|B2|Baseline|MN-001 500 mg BID|Patients received MN-001 500 mg BID. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
1201352|NCT00295854|B1|Baseline|MN-001 500 mg qd|This group received MN-001 500mg orally (PO)once a day. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
1201353|NCT00295854|P3|Participant Flow|Placebo|Patients received placebo. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
1201354|NCT00295854|P2|Participant Flow|MN-001 500 mg BID|Patients received MN-001 500 mg BID. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
1201355|NCT00295854|P1|Participant Flow|MN-001 500 mg qd|This group received MN-001 500mg orally (PO)once a day. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
1201356|NCT00295854|O3|Outcome|Placebo|Patients received placebo. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
1201357|NCT00295854|O2|Outcome|MN-001 500 mg BID|Patients received MN-001 500 mg BID. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
1201358|NCT00295854|O1|Outcome|MN-001 500 mg qd|This group received MN-001 500mg orally (PO)once a day. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
1201359|NCT00295854|O3|Outcome|Placebo|Patients received placebo. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
1201360|NCT00295854|O2|Outcome|MN-001 500 mg BID|Patients received MN-001 500 mg BID. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
1201361|NCT00295854|O1|Outcome|MN-001 500 mg qd|This group received MN-001 500mg orally (PO)once a day. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
1201398|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
1202601|NCT00291187|P2|Participant Flow|VEC-162 20 mg|20 mg taken orally 30 minutes prior to bedtime
1201362|NCT00295854|E3|Reported Event|Placebo|Patients received placebo. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
1201363|NCT00295854|E2|Reported Event|MN-001 500 mg BID|Patients received MN-001 500 mg BID. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
1201364|NCT00295854|E1|Reported Event|MN-001 500 mg qd|This group received MN-001 500mg orally (PO)once a day. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
1201365|NCT00295750|B4|Baseline|Total|Total of all reporting groups
1201366|NCT00295750|B3|Baseline|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
1201367|NCT00295750|B2|Baseline|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
1201368|NCT00295750|B1|Baseline|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
1201369|NCT00295750|P3|Participant Flow|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
1201370|NCT00295750|P2|Participant Flow|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
1201371|NCT00295750|P1|Participant Flow|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
1201372|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
1201373|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
1201374|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
1201375|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
1201376|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
1201377|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
1201378|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
1201379|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
1201380|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
1201381|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
1201382|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
1201383|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
1201384|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
1201385|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
1201386|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
1201387|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
1201388|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
1201389|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
1201390|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
1201391|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
1201392|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
1201393|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
1201394|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
1201395|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
1201399|NCT00295750|E3|Reported Event|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
1201400|NCT00295750|E2|Reported Event|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
1201401|NCT00295750|E1|Reported Event|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
1201402|NCT00295633|B4|Baseline|Total|Total of all reporting groups
1201403|NCT00295633|B3|Baseline|Placebo Plus Open-label TZD|The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
1201404|NCT00295633|B2|Baseline|Saxagliptin 5 mg Plus Open-label TZD|The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
1201405|NCT00295633|B1|Baseline|Saxagliptin 2.5 mg Plus Open-label TZD|The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
1201406|NCT00295633|P3|Participant Flow|Placebo Plus Open-label TZD|The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
1201407|NCT00295633|P2|Participant Flow|Saxagliptin 5 mg Plus Open-label TZD|The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
1201408|NCT00295633|P1|Participant Flow|Saxagliptin 2.5 mg Plus Open-label Thiazolidinedione (TZD)|The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
1201409|NCT00295633|O3|Outcome|Placebo Plus Open-label TZD|The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
1201410|NCT00295633|O2|Outcome|Saxagliptin 5 mg Plus Open-label TZD|The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
1201411|NCT00295633|O1|Outcome|Saxagliptin 2.5 mg Plus Open-label TZD|The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
1201412|NCT00295633|O3|Outcome|Placebo Plus Open-label TZD|The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
1201413|NCT00295633|O2|Outcome|Saxagliptin 5 mg Plus Open-label TZD|The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
1201414|NCT00295633|O1|Outcome|Saxagliptin 2.5 mg Plus Open-label TZD|The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
1201415|NCT00295633|O3|Outcome|Placebo Plus Open-label TZD|The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
1201416|NCT00295633|O2|Outcome|Saxagliptin 5 mg Plus Open-label TZD|The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
1201417|NCT00295633|O1|Outcome|Saxagliptin 2.5 mg Plus Open-label TZD|The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
1201418|NCT00295633|O3|Outcome|Placebo Plus Open-label TZD|The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
1201419|NCT00295633|O2|Outcome|Saxagliptin 5 mg Plus Open-label TZD|The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
1201420|NCT00295633|O1|Outcome|Saxagliptin 2.5 mg Plus Open-label TZD|The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
1201421|NCT00295633|E3|Reported Event|SAXA 5MG + TZD|
1201422|NCT00295633|E2|Reported Event|SAXA 2.5MG + TZD|
1201423|NCT00295633|E1|Reported Event|PLA + TZD|
1201424|NCT00295503|B1|Baseline|Cisplatin, Pemetrexed and Bevacizumab|cisplatin 75 mg/m2, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg IV every 3 weeks
1201425|NCT00295503|P1|Participant Flow|Cisplatin, Pemetrexed and Bevacizumab|cisplatin 75 mg/m2, pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg IV every 3 weeks
1201426|NCT00295503|O1|Outcome|Cisplatin, Pemetrexed and Bevacizumab|cisplatin 75 mg/m2, pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg IV every 3 weeks
1201427|NCT00295503|O1|Outcome|Cisplatin, Pemetrexed, Bevacizumab|cisplatin 75 mg/m2, pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg IV every 3 weeks
1201428|NCT00295503|O1|Outcome|Cisplatin, Pemetrexed, Bevacizumab|cisplatin 75 mg/m2, pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg IV every 3 weeks
1201429|NCT00295503|E1|Reported Event|Experimental Arm|cisplatin, pemetrexed, and bevacizumab
1201430|NCT00295490|B5|Baseline|Total|Total of all reporting groups
1201431|NCT00295490|B4|Baseline|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
1201432|NCT00295490|B3|Baseline|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
1201433|NCT00295490|B2|Baseline|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
1201434|NCT00295490|B1|Baseline|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
1201435|NCT00295490|P4|Participant Flow|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
1201436|NCT00295490|P3|Participant Flow|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
1201437|NCT00295490|P2|Participant Flow|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
1201438|NCT00295490|P1|Participant Flow|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
1201490|NCT00295009|B1|Baseline|1-Level Fusion|Circumferential fusion at a single lumbar level.
1203750|NCT00288704|O1|Outcome|Placebo|
1201439|NCT00295490|O4|Outcome|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
1201440|NCT00295490|O3|Outcome|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
1201441|NCT00295490|O2|Outcome|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
1201442|NCT00295490|O1|Outcome|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
1201443|NCT00295490|O4|Outcome|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
1201444|NCT00295490|O3|Outcome|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
1201445|NCT00295490|O2|Outcome|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
1201446|NCT00295490|O1|Outcome|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
1201447|NCT00295490|O4|Outcome|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
1201448|NCT00295490|O3|Outcome|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
1201449|NCT00295490|O2|Outcome|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
1201450|NCT00295490|O1|Outcome|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
1201781|NCT00294515|O2|Outcome|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
1201451|NCT00295490|O4|Outcome|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
1201452|NCT00295490|O3|Outcome|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
1201453|NCT00295490|O2|Outcome|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
1201454|NCT00295490|O1|Outcome|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
1201455|NCT00295490|O4|Outcome|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
1201456|NCT00295490|O3|Outcome|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
1201457|NCT00295490|O2|Outcome|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
1201458|NCT00295490|O1|Outcome|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
1201459|NCT00295490|O4|Outcome|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
1201460|NCT00295490|O3|Outcome|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
1201491|NCT00295009|P6|Participant Flow|2-Level ProDisc (Continued Access)|Non-randomized total disc arthroplasty with the ProDisc device at two spinal lumbar levels. Continued Access patients only followed out to 24 months.
1201461|NCT00295490|O2|Outcome|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
1201462|NCT00295490|O1|Outcome|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
1201463|NCT00295490|O4|Outcome|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
1201464|NCT00295490|O3|Outcome|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
1201465|NCT00295490|O2|Outcome|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
1201466|NCT00295490|O1|Outcome|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
1201467|NCT00295490|O4|Outcome|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
1201468|NCT00295490|O3|Outcome|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
1201469|NCT00295490|O2|Outcome|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
1201470|NCT00295490|O1|Outcome|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
1201471|NCT00295490|E4|Reported Event|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
1201472|NCT00295490|E3|Reported Event|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
1201473|NCT00295490|E2|Reported Event|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
1201474|NCT00295490|E1|Reported Event|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
1201475|NCT00295061|B3|Baseline|Total|Total of all reporting groups
1201476|NCT00295061|B2|Baseline|Prolastin / Alpha-1 MP|Sequential, blinded treatment periods of Prolastin (active comparator), then crossed-over to Alpha-1 MP (experimental), followed by open-label Alpha-1 MP
1201477|NCT00295061|B1|Baseline|Alpha-1 MP / Prolastin|Sequential, blinded treatment periods of Alpha-1 MP (experimental), then crossed-over to Prolastin (active comparator), followed by open-label Alpha-1 MP
1201478|NCT00295061|P2|Participant Flow|Prolastin / Alpha-1 MP|Sequential, blinded treatment periods of Prolastin (active comparator), then crossed-over to Alpha-1 MP (experimental), followed by open-label Alpha-1 MP
1201479|NCT00295061|P1|Participant Flow|Alpha-1 MP / Prolastin|Sequential, blinded treatment periods of Alpha-1 modified process (MP) (experimental), then crossed-over to Prolastin (active comparator), followed by open-label Alpha-1 MP
1201480|NCT00295061|O2|Outcome|Prolastin|Sequential, blinded treatment periods of Prolastin (active comparator), then crossed-over to Alpha-1 MP (experimental), followed by open-label Alpha-1 MP
1201481|NCT00295061|O1|Outcome|Alpha-1 MP|Sequential, blinded treatment periods of Alpha-1 MP (experimental), then crossed-over to Prolastin (active comparator), followed by open-label Alpha-1 MP
1201482|NCT00295061|E2|Reported Event|Prolastin|Sequential, blinded treatment periods of Prolastin (active comparator), then crossed-over to Alpha-1 MP (experimental), followed by open-label Alpha-1 MP
1201483|NCT00295061|E1|Reported Event|Alpha-1 MP|Sequential, blinded treatment periods of Alpha-1 MP (experimental), then crossed-over to Prolastin (active comparator), followed by open-label Alpha-1 MP
1201484|NCT00295009|B7|Baseline|Total|Total of all reporting groups
1201485|NCT00295009|B6|Baseline|2-Level ProDisc (Continued Access)|Non-randomized total disc arthroplasty with the ProDisc device at two spinal lumbar levels. Continued Access patients only followed out to 24 months.
1201486|NCT00295009|B5|Baseline|2-Level ProDisc|Total disc arthroplasty with the ProDisc device at two adjacent lumbar levels.
1201487|NCT00295009|B4|Baseline|2-Level Fusion|Circumferential fusion at two adjacent lumbar levels.
1201488|NCT00295009|B3|Baseline|1-Level ProDisc (Non-randomized)|Non-randomized total disc arthroplasty with the ProDisc device at one spinal lumbar level.
1201489|NCT00295009|B2|Baseline|1-Level ProDisc|Total disc arthroplasty with the ProDisc device at one spinal lumbar level.
1201492|NCT00295009|P5|Participant Flow|2-Level ProDisc|Total disc arthroplasty with the ProDisc device at two adjacent lumbar levels.
1201493|NCT00295009|P4|Participant Flow|2-Level Fusion|Circumferential fusion at two adjacent lumbar levels.
1201494|NCT00295009|P3|Participant Flow|1-Level ProDisc (Non-Randomized)|Non-randomized total disc arthroplasty with the ProDisc device at one spinal lumbar level.
1201495|NCT00295009|P2|Participant Flow|1-Level ProDisc|Total disc arthroplasty with the ProDisc device at one spinal lumbar level.
1201496|NCT00295009|P1|Participant Flow|1-Level Fusion|Circumferential fusion at a single lumbar level.
1201497|NCT00295009|O6|Outcome|2-Level ProDisc (Continued Access)|Non-randomized total disc arthroplasty with the ProDisc device at two spinal lumbar levels. Continued Access patients only followed out to 24 months.
1201498|NCT00295009|O5|Outcome|2-Level ProDisc|Total disc arthroplasty with the ProDisc device at two adjacent lumbar levels.
1201499|NCT00295009|O4|Outcome|2-Level Fusion|Circumferential fusion at two adjacent lumbar levels.
1201500|NCT00295009|O3|Outcome|1-Level ProDisc (Non-randomized)|Non-randomized total disc arthroplasty with the ProDisc device at one spinal lumbar level.
1201501|NCT00295009|O2|Outcome|1-Level ProDisc|Total disc arthroplasty with the ProDisc device at one spinal lumbar level.
1201502|NCT00295009|O1|Outcome|1-Level Fusion|Circumferential fusion at a single lumbar level.
1201503|NCT00295009|O6|Outcome|2-Level ProDisc (Continued Access)|Non-randomized total disc arthroplasty with the ProDisc device at two spinal lumbar levels. Continued Access patients only followed out to 24 months.
1201504|NCT00295009|O5|Outcome|2-Level ProDisc|Total disc arthroplasty with the ProDisc device at two adjacent lumbar levels.
1201505|NCT00295009|O4|Outcome|2-Level Fusion|Circumferential fusion at two adjacent lumbar levels.
1201506|NCT00295009|O3|Outcome|1-Level ProDisc (Non-randomized)|Non-randomized total disc arthroplasty with the ProDisc device at one spinal lumbar level.
1201507|NCT00295009|O2|Outcome|1-Level ProDisc|Total disc arthroplasty with the ProDisc device at one spinal lumbar level.
1201508|NCT00295009|O1|Outcome|1-Level Fusion|Circumferential fusion at a single lumbar level.
1201509|NCT00295009|E6|Reported Event|2-Level ProDisc (Continued Access)|Non-randomized total disc arthroplasty with the ProDisc device at two spinal lumbar levels. Continued Access patients only followed out to 24 months.
1201510|NCT00295009|E5|Reported Event|2-Level ProDisc|Total disc arthroplasty with the ProDisc device at two adjacent lumbar levels.
1201511|NCT00295009|E4|Reported Event|2-Level Fusion|Circumferential fusion at two adjacent lumbar levels.
1201512|NCT00295009|E3|Reported Event|1-Level ProDisc (Non-Randomized)|Non-randomized total disc arthroplasty with the ProDisc device at one spinal lumbar level.
1201513|NCT00295009|E2|Reported Event|1-Level ProDisc|Total disc arthroplasty with the ProDisc device at one spinal lumbar level.
1201514|NCT00295009|E1|Reported Event|1-Level Fusion|Circumferential fusion at a single lumbar level.
1201515|NCT00292370|B4|Baseline|Total|Total of all reporting groups
1201516|NCT00292370|B3|Baseline|Arm 3/OL Paroxetine & Double-blind Quetiapine|"Phase II: Double-blind quetiapine~In Phase II, participants will continue taking open-label paroxetine and will be randomized to the addition of quetiapine in a double-blind fashion."
1201782|NCT00294515|O1|Outcome|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
1201517|NCT00292370|B2|Baseline|Arm 2/OL Paroxetine & Double-blind Placebo|"Phase II: Double-blind placebo~In Phase II, participants will continue taking open-label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind fashion."
1201518|NCT00292370|B1|Baseline|Arm 1/Open-Label (OL) Paroxetine|"Phase I : Open-label Paroxetine~In Phase I, eligible participants will take open-label (OL) paroxetine (up to 60 mg daily) for 8 weeks. Participants who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS score of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for Phase II"
1201519|NCT00292370|P3|Participant Flow|Arm 3/OL Paroxetine & Double-blind Quetiapine|"Phase II : Double-blind quetiapine~In Phase II, participants will continue taking open-label paroxetine and will be randomized to the addition of quetiapine for 8 weeks in a double-blind fashion."
1201520|NCT00292370|P2|Participant Flow|Arm 2/OL Paroxetine & Double-blind Placebo|"Phase II : Double-blind placebo~In Phase II, participants will continue taking open-label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind fashion."
1201521|NCT00292370|P1|Participant Flow|Arm 1/Open-Label (OL) Paroxetine|"Phase I : Open-label Paroxetine~In Phase I, eligible participants will take open-label (OL) paroxetine (up to 60 mg daily) for 8 weeks. Participants who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS score of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for Phase II"
1201522|NCT00292370|O2|Outcome|Arm 3: OL Paroxetine + DB Quetiapine|"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.~Open Label (OL) Paroxetine: Open-label Paroxetine~Quetiapine: Double-blind quetiapine taken with OL paroxetine"
1201523|NCT00292370|O1|Outcome|Arm 2 OL Paroxetine + DB Placebo|"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind (DB) fashion.~Open Label (OL) Paroxetine: Open-label Paroxetine~Placebo: Double-blind placebo taken with OL paroxetine"
1201524|NCT00292370|E3|Reported Event|Arm 3: OL Paroxetine + DB Quetiapine|"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.~Open Label (OL) Paroxetine: Open-label Paroxetine~Quetiapine: Double-blind quetiapine taken with OL paroxetine"
1201525|NCT00292370|E2|Reported Event|Arm 2 OL Paroxetine + DB Placebo|"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind (DB) fashion.~Open Label (OL) Paroxetine: Open-label Paroxetine~Placebo: Double-blind placebo taken with OL paroxetine"
1201526|NCT00292370|E1|Reported Event|Arm 1: Open Label (OL) Paroxetine|"In Phase I, eligible participants will take open-label (OL) Paroxetine (up to 60 mg) daily for 8 weeks. Participants who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for Phase II.~Open Label (OL) Paroxetine: Open-label Paroxetine"
1201527|NCT00294762|B3|Baseline|Total|Total of all reporting groups
1202141|NCT00293241|O2|Outcome|MVP Off|Managed Ventricular Pacing programmed off: conventional pacing
1201528|NCT00294762|B2|Baseline|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
1201529|NCT00294762|B1|Baseline|Erlotinib|150 mg erlotinib daily
1201530|NCT00294762|P2|Participant Flow|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
1201531|NCT00294762|P1|Participant Flow|Erlotinib|150 mg erlotinib daily
1201532|NCT00294762|O2|Outcome|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
1201533|NCT00294762|O1|Outcome|Erlotinib|150 mg erlotinib daily
1201534|NCT00294762|O2|Outcome|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
1201535|NCT00294762|O1|Outcome|Erlotinib|150 mg erlotinib daily
1201536|NCT00294762|O2|Outcome|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
1201537|NCT00294762|O1|Outcome|Erlotinib|150 mg erlotinib daily
1201538|NCT00294762|O2|Outcome|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
1201539|NCT00294762|O1|Outcome|Erlotinib|150 mg erlotinib daily
1201540|NCT00294762|O2|Outcome|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
1201541|NCT00294762|O1|Outcome|Erlotinib|150 mg erlotinib daily
1201542|NCT00294762|O2|Outcome|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
1201543|NCT00294762|O1|Outcome|Erlotinib|150 mg erlotinib daily
1201544|NCT00294762|E2|Reported Event|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
1201545|NCT00294762|E1|Reported Event|Erlotinib|150 mg erlotinib daily
1201546|NCT00294723|B4|Baseline|Total|Total of all reporting groups
1201547|NCT00294723|B3|Baseline|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
1201548|NCT00294723|B2|Baseline|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
1201549|NCT00294723|B1|Baseline|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
1201550|NCT00294723|P3|Participant Flow|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
1201551|NCT00294723|P2|Participant Flow|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
1201552|NCT00294723|P1|Participant Flow|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
1201553|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
1201554|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
1201555|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
1201556|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
1201557|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
1201558|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
1201559|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
1201560|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
1201561|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
1201562|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
1201563|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
1201564|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
1201565|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
1201566|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
1201567|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
1201568|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
1201569|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
1201570|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
1201571|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
1201572|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
1201573|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
1201574|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
1201575|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
1201576|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
1201577|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
1201933|NCT00293813|E1|Reported Event|Placebo|
1201578|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
1201579|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
1201580|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
1201581|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
1201582|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
1201583|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
1201584|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
1201585|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
1201586|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
1201587|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
1201588|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
1201589|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
1201590|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
1201591|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
1201592|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
1203751|NCT00288704|O2|Outcome|Rilonacept 160 mg|
1201593|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
1201594|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
1201595|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
1201596|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
1201597|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
1201598|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
1201599|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
1201600|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
1201601|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
1201602|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
1201603|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
1201604|NCT00294723|E6|Reported Event|Glimepiride (Weeks 104-195)|Open-label glimepiride 8 mg once daily in the additional extension period (weeks 104-195)
1201605|NCT00294723|E5|Reported Event|Lira 1.2 (Weeks 104-195)|Open-label liraglutide 1.2 mg once daily in the additional extension period (weeks 104-195)
1201606|NCT00294723|E4|Reported Event|Lira 1.8 (Weeks 104-195)|Open-label liraglutide 1.8 mg once daily in the additional extension period (weeks 104-195)
1201607|NCT00294723|E3|Reported Event|Glimepiride (Weeks 0-104)|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension period (weeks 52-104)
1201608|NCT00294723|E2|Reported Event|Lira 1.2 (Weeks 0-104)|Liraglutide 1.2 mg once daily + glimepiride placebo 8mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension period (weeks 52-104)
1201609|NCT00294723|E1|Reported Event|Lira 1.8 (Weeks 0-104)|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension period (weeks 52-104)
1201610|NCT00294684|B3|Baseline|Total|Total of all reporting groups
1201611|NCT00294684|B2|Baseline|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
1201612|NCT00294684|B1|Baseline|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
1201613|NCT00294684|P2|Participant Flow|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
1201614|NCT00294684|P1|Participant Flow|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
1201673|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
1201674|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
1201755|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
1201615|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
1201616|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
1201617|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
1201618|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
1201619|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
1201696|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
1201620|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
1201621|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
1201622|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
1201623|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
1201624|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
1201675|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
1201676|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
1202142|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
1201625|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
1201626|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
1201627|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
1201628|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
1201629|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
1201630|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
1201631|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
1201632|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
1201633|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
1201634|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
1201677|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
1201678|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
1202143|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
1201635|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
1201636|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
1201637|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
1201638|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
1201639|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
1201640|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
1201641|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
1201642|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
1201643|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
1201644|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
1201679|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
1201680|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
1202144|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
1201645|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
1201646|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
1201647|NCT00294684|O2|Outcome|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
1201648|NCT00294684|O1|Outcome|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
1201649|NCT00294684|E2|Reported Event|Placebo|"Placebo: Schedule and dosing of placebo following portoenterostomy in infants with biliary atresia:~Days 1-3: IV - normal saline 4 mg/kg/day, divided BID Days 4-7: PO placebo 4 mg/kg/day, divided BID Week 2: PO placebo 4 mg/kg/day, divided BID Week 3: PO placebo 2 mg/kg/day, divided BID Week 4: PO placebo 2 mg/kg/day, divided BID Week 5: PO placebo 1 mg/kg/day, once a day Week 6: PO placebo 1 mg/kg/day, once a day Week 7: PO placebo 0.8 mg/kg/day, once a day Week 8: PO placebo 0.6 mg/kg/day, once a day Week 9: PO placebo 0.4 mg/kg/day, once a day Week 10: PO placebo 0.2 mg/kg/day, once a day Week 11: PO placebo 0.1 mg/kg/day, once a day Week 12-13: PO placebo 0.1 mg/kg/day, once a day every other day Week 14: Stop"
1201650|NCT00294684|E1|Reported Event|Corticosteroids|"Corticosteroids: Schedule and dosing of corticosteroids following portoenterostomy in infants with biliary atresia are listed below.~Days 1-3: Methylprednisolone, IV-4mg/kg/day, divided BID Days 4-7: Prednisolone, PO-4mg/kg/day, divided BID Week 2: 4 mg/kg/day, divided BID Week 3: 2 mg/kg/day, divided BID Week 4: 2 mg/kg/day, divided BID Week 5: 1 mg/kg/day, once a day Week 6: 1 mg/kg/day, once a day Week 7: 0.8 mg/kg/day, once a day Week 8: 0.6 mg/kg/day, once a day Week 9: 0.4 mg/kg/day, once a day Week 10: 0.2 mg/kg/day, once a day Week 11: 0.1 mg/kg/day, once a day Week 12-13: 0.1 mg/kg/day, every other day Week 14: Stop"
1201651|NCT00294671|B3|Baseline|Total|Total of all reporting groups
1201652|NCT00294671|B2|Baseline|Placebo|Placebo, an inactive substance, taken by mouth twice daily for 24 months
1201653|NCT00294671|B1|Baseline|Diflunisal|Diflunisal 250 mg taken by mouth twice daily for 24 months
1201654|NCT00294671|P2|Participant Flow|Placebo|Placebo, an inactive substance, taken by mouth twice daily for 24 months
1201655|NCT00294671|P1|Participant Flow|Diflunisal|Diflunisal 250 mg taken by mouth twice daily for 24 months
1201656|NCT00294671|O2|Outcome|Placebo|Placebo, an inactive substance, taken by mouth twice daily for 24 months
1201657|NCT00294671|O1|Outcome|Diflunisal|Diflunisal 250 mg taken by mouth twice daily for 24 months
1201658|NCT00294671|O2|Outcome|Placebo|Placebo, an inactive substance, taken by mouth twice daily for 24 months
1201659|NCT00294671|O1|Outcome|Diflunisal|Diflunisal 250 mg taken by mouth twice daily for 24 months
1201660|NCT00294671|O2|Outcome|Placebo|Placebo, an inactive substance, taken by mouth twice daily for 24 months
1201661|NCT00294671|O1|Outcome|Diflunisal|Diflunisal 250 mg taken by mouth twice daily for 24 months
1201662|NCT00294671|O2|Outcome|Placebo|Placebo, an inactive substance, taken by mouth twice daily for 24 months
1201663|NCT00294671|O1|Outcome|Diflunisal|Diflunisal 250 mg taken by mouth twice daily for 24 months
1201664|NCT00294671|O2|Outcome|Placebo|Placebo, an inactive substance, taken by mouth twice daily for 24 months
1201665|NCT00294671|O1|Outcome|Diflunisal|Diflunisal 250 mg taken by mouth twice daily for 24 months
1201666|NCT00294671|E2|Reported Event|Placebo|Placebo, an inactive substance, taken by mouth twice daily for 24 months
1201667|NCT00294671|E1|Reported Event|Diflunisal|Diflunisal 250 mg taken by mouth twice daily for 24 months
1201668|NCT00294658|B3|Baseline|Total|Total of all reporting groups
1201669|NCT00294658|B2|Baseline|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
1201670|NCT00294658|B1|Baseline|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
1201671|NCT00294658|P2|Participant Flow|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen had been taken every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
1201672|NCT00294658|P1|Participant Flow|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy had been performed as soon as possible after randomization."
1201754|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
1203752|NCT00288704|O1|Outcome|Placebo|
1201681|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
1201682|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
1201683|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
1201684|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
1201685|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
1201686|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
1201687|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
1201688|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
1201689|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
1201690|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
1201691|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
1201692|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
1201693|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
1201694|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
1201695|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
1202477|NCT00292461|O2|Outcome|Lamotrigine|once daily orally for 16 weeks
1201697|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
1201698|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
1201699|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
1201700|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
1201701|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
1201702|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
1201703|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
1201704|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
1201705|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
1201706|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
1201707|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
1201708|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
1201709|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
1201710|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
1201711|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
1201712|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
1201713|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
1203753|NCT00288704|O2|Outcome|Rilonacept 160 mg|
1201714|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
1201715|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
1201716|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
1201717|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
1201718|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
1201719|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
1201720|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
1201721|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
1201722|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
1201723|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
1201724|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
1201725|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
1201726|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
1201727|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
1201728|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
1201729|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
1201730|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
1201731|NCT00294658|E2|Reported Event|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
1201732|NCT00294658|E1|Reported Event|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
1201733|NCT00294645|B3|Baseline|Total|Total of all reporting groups
1201734|NCT00294645|B2|Baseline|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
1201735|NCT00294645|B1|Baseline|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
1201736|NCT00294645|P2|Participant Flow|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
1201737|NCT00294645|P1|Participant Flow|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
1201738|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
1201739|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
1201740|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
1201741|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
1201742|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
1201743|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
1201744|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
1201745|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
1201746|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
1201747|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
1201748|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
1201749|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
1201750|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
1201751|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
1201752|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
1201753|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
1201756|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
1201757|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
1201758|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
1201759|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
1201760|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
1201761|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
1201762|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
1201763|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
1201764|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
1201765|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
1201766|NCT00294645|E2|Reported Event|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
1201767|NCT00294645|E1|Reported Event|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
1201768|NCT00294515|B3|Baseline|Total|Total of all reporting groups
1201769|NCT00294515|B2|Baseline|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
1201770|NCT00294515|B1|Baseline|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
1201771|NCT00294515|P2|Participant Flow|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
1201772|NCT00294515|P1|Participant Flow|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
1201773|NCT00294515|O2|Outcome|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
1201774|NCT00294515|O1|Outcome|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
1201775|NCT00294515|O2|Outcome|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
1201776|NCT00294515|O1|Outcome|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
1201777|NCT00294515|O2|Outcome|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
1201778|NCT00294515|O1|Outcome|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
1201779|NCT00294515|O2|Outcome|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
1201780|NCT00294515|O1|Outcome|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
1202478|NCT00292461|O1|Outcome|Zonegran|once or twice daily orally for 16 weeks
1201783|NCT00294515|E2|Reported Event|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
1201784|NCT00294515|E1|Reported Event|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
1201785|NCT00294398|B3|Baseline|Total|Total of all reporting groups
1201786|NCT00294398|B2|Baseline|ICS Prescription + Standard ED Discharge Therapy|"Subjects were given a prescription for a 30 day supply of an inhaled corticosteroid based on age:~1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily"
1201787|NCT00294398|B1|Baseline|Standard Asthma ED Discharge Therapy|Subjects were instructed to use albuterol as needed (up to every 4 hours), may have been prescribed prednisone and asked to follow-up with their primary doctor in 3-5 days. All viewed an educational video about asthma control and are provided a home nebulizer if needed.
1201788|NCT00294398|P2|Participant Flow|ICS Prescription + Standard Asthma ED Discharge Therapy|"Subjects were given a prescription for a 30 day supply of an inhaled corticosteroid based on age:~1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily"
1201789|NCT00294398|P1|Participant Flow|Standard Asthma ED Discharge Therapy|Subjects were instructed to use albuterol as needed (up to every 4 hours), may have been prescribed prednisone and asked to follow-up with their primary doctor in 3-5 days. All viewed an educational video about asthma control and were provided a home nebulizer if needed.
1201790|NCT00294398|O2|Outcome|ICS Prescription + Standard Asthma ED Discharge Therapy:|"Subjects are given a prescription for a 30 day supply of an inhaled corticosteroid based on age:~1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily"
1201791|NCT00294398|O1|Outcome|Standard Asthma ED Discharge Therapy|Subjects are instructed to use albuterol as needed (up to every 4 hours), may be prescribed prednisone and to follow-up with their primary doctor in 3-5 days. All view an educational video about asthma control and are provided a home nebulizer if needed.
1201792|NCT00294398|O2|Outcome|ICS Prescription + Standard Asthma ED Discharge Therapy:|"Subjects are given a prescription for a 30 day supply of an inhaled corticosteroid based on age:~1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily"
1201793|NCT00294398|O1|Outcome|Standard Asthma ED Discharge Therapy|Subjects are instructed to use albuterol as needed (up to every 4 hours), may be prescribed prednisone and to follow-up with their primary doctor in 3-5 days. All view an educational video about asthma control and are provided a home nebulizer if needed.
1201794|NCT00294398|E2|Reported Event|ICS Prescription + Standard Asthma ED Discharge Therapy|"Subjects are given a prescription for a 30 day supply of an inhaled corticosteroid based on age:~1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily"
1203754|NCT00288704|O1|Outcome|Placebo|
1201795|NCT00294398|E1|Reported Event|Standard Asthma ED Discharge Therapy|Subjects are instructed to use albuterol as needed (up to every 4 hours), may be prescribed prednisone and to follow-up with their primary doctor in 3-5 days. All view an educational video about asthma control and are provided a home nebulizer if needed.
1201796|NCT00294060|B1|Baseline|Pacing Patients|Patients implanted with a pacemaker.
1201797|NCT00294060|P1|Participant Flow|Pacing Patients|Patients implanted with a pacemaker.
1201798|NCT00294060|O1|Outcome|Pacing Patients|Patients implanted with a pacemaker.
1201799|NCT00294060|O1|Outcome|Pacing Patients|Patients implanted with a pacemaker.
1201800|NCT00294060|O1|Outcome|Pacing Patients|Patients implanted with a pacemaker.
1201801|NCT00294060|E1|Reported Event|Pacing Patients|Patients implanted with a pacemaker.
1201802|NCT00294047|B3|Baseline|Total|Total of all reporting groups
1201803|NCT00294047|B2|Baseline|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201804|NCT00294047|B1|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201805|NCT00294047|P2|Participant Flow|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201806|NCT00294047|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201807|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201808|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201809|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201810|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201811|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201812|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1202479|NCT00292461|O2|Outcome|Lamotrigine|once daily orally for 16 weeks
1201813|NCT00294047|O2|Outcome|Aluminium Hydroxide|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201814|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201815|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201816|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201817|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201818|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201819|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201820|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201821|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201822|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201823|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201824|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201825|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201826|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201827|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201828|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201829|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201830|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201831|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201832|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201833|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201834|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201835|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201836|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201837|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201838|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201839|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201840|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201841|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201842|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201843|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201844|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201845|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201846|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201847|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201848|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201849|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201850|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201851|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201852|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201853|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201854|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201855|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201856|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201857|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201858|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201859|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201860|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201861|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201862|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201863|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201864|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201865|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201866|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201867|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201868|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201869|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201870|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201871|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201872|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201873|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201874|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201875|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201876|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201877|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201878|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201879|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201880|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201881|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201882|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201883|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201884|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201885|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201886|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201887|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201888|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201889|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201890|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201891|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201892|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201893|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201894|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201895|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201896|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201897|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201898|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201899|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201900|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201901|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201902|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201903|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201904|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201905|NCT00294047|E2|Reported Event|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201906|NCT00294047|E1|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1201907|NCT00292318|B3|Baseline|Total|Total of all reporting groups
1201908|NCT00292318|B2|Baseline|Study Grp/Biofeedback|"Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.~Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem."
1201909|NCT00292318|B1|Baseline|Control|"Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.~control group: Medical counseling and ano-sphinctal exercises."
1201910|NCT00292318|P2|Participant Flow|Study Grp/Biofeedback|"Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.~Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem."
1201911|NCT00292318|P1|Participant Flow|Control|"Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.~control group: Medical counseling and ano-sphinctal exercises."
1201948|NCT00293709|B1|Baseline|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
1202145|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
1201912|NCT00292318|O2|Outcome|Study Grp/Biofeedback|"Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.~Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem."
1201913|NCT00292318|O1|Outcome|Control|"Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.~control group: Medical counseling and ano-sphinctal exercises."
1201914|NCT00292318|O2|Outcome|Study Grp/Biofeedback|"Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.~Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem."
1201915|NCT00292318|O1|Outcome|Control|"Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.~control group: Medical counseling and ano-sphinctal exercises."
1201916|NCT00292318|E2|Reported Event|Study Grp/Biofeedback|"Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.~Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem."
1201917|NCT00292318|E1|Reported Event|Control|"Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.~control group: Medical counseling and ano-sphinctal exercises."
1201918|NCT00293813|B4|Baseline|Total|Total of all reporting groups
1201919|NCT00293813|B3|Baseline|Placebo|Placebo
1201920|NCT00293813|B2|Baseline|Denosumab 60 mg Q6M|Denosumab 60 mg Q6M
1201921|NCT00293813|B1|Baseline|Alendronate 70 mg QW|Alendronate 70 mg QW
1201922|NCT00293813|P3|Participant Flow|Placebo|Placebo
1201923|NCT00293813|P2|Participant Flow|Denosumab 60 mg Q6M|Denosumab 60 mg Q6M
1201924|NCT00293813|P1|Participant Flow|Alendronate 70 mg QW|Alendronate 70 mg QW
1201925|NCT00293813|O3|Outcome|Placebo|Placebo
1201926|NCT00293813|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg Q6M
1201927|NCT00293813|O1|Outcome|Alendronate 70 mg QW|Alendronate 70 mg QW
1201928|NCT00293813|O3|Outcome|Placebo|Placebo
1201929|NCT00293813|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg Q6M
1201930|NCT00293813|O1|Outcome|Alendronate 70 mg QW|Alendronate 70 mg QW
1201931|NCT00293813|E3|Reported Event|Denosumab 60 mg Q6M|
1201932|NCT00293813|E2|Reported Event|Alendronate 70 mg QW|
1201934|NCT00293722|B1|Baseline|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
1201935|NCT00293722|P1|Participant Flow|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
1201936|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
1201937|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
1201938|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
1201939|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
1201940|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
1201941|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
1201942|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
1201943|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
1201944|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
1201945|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
1201946|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
1201947|NCT00293722|E1|Reported Event|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
1201949|NCT00293709|P1|Participant Flow|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
1201950|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
1201951|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
1201952|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
1201953|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
1201954|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
1201955|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
1201956|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
1201957|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
1201958|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
1201959|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
1201960|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
1201961|NCT00293709|E1|Reported Event|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
1201962|NCT00293579|B1|Baseline|Pemetrexed|pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
1201963|NCT00293579|P1|Participant Flow|Pemetrexed|pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
1201964|NCT00293579|O1|Outcome|Pemetrexed|pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
1201965|NCT00293579|O1|Outcome|Pemetrexed|"pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles~Pemetrexed: 500 mg/m2 IV every 3 weeks for 6 cycles"
1201966|NCT00293579|O1|Outcome|Pemetrexed|pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
1201967|NCT00293579|O1|Outcome|Pemetrexed|pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
1201968|NCT00293579|E1|Reported Event|Pemetrexed|pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
1201969|NCT00293540|B3|Baseline|Total|Total of all reporting groups
1201970|NCT00293540|B2|Baseline|B Mid-follicular Surgery|
1201971|NCT00293540|B1|Baseline|A Mid-luteal Surgery|
1201972|NCT00293540|P2|Participant Flow|B Mid-follicular Surgery|
1201973|NCT00293540|P1|Participant Flow|A Mid-luteal Surgery|
1201974|NCT00293540|O2|Outcome|B Mid-follicular Surgery|
1201975|NCT00293540|O1|Outcome|A Mid-luteal Surgery|
1201976|NCT00293540|E2|Reported Event|B Mid-follicular Surgery|
1201977|NCT00293540|E1|Reported Event|A Mid-luteal Surgery|
1201978|NCT00293462|B4|Baseline|Total|Total of all reporting groups
1201979|NCT00293462|B3|Baseline|Arm III: Salt & Soda Switched to GM-CSF (SG)|Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
1201980|NCT00293462|B2|Baseline|Arm II: Salt & Soda Group (SS)|Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
1201981|NCT00293462|B1|Baseline|Arm I: GM-CSF Group (GG)|Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
1201982|NCT00293462|P3|Participant Flow|Arm III: Salt & Soda Switched to GM-CSF (SG)|Arm III: Patients were randomized to receive oral salt and soda (SS) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving GM-CSF treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
1201983|NCT00293462|P2|Participant Flow|Arm II: Salt & Soda Group (SS)|Arm II: Patients were randomized to receive salt and soda (SS) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving SS treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
1201984|NCT00293462|P1|Participant Flow|Arm I: GM-CSF Group (GG)|Arm I: Patients were randomized to receive oral sargramostim (GM-CSF) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving GM-CSF treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
1201985|NCT00293462|O3|Outcome|Arm III: Salt & Soda Switched to GM-CSF (SG)|Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
1202139|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
1201986|NCT00293462|O2|Outcome|Arm II: Salt & Soda Group (SS)|Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
1201987|NCT00293462|O1|Outcome|Arm I: GM-CSF Group (GG)|Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
1201988|NCT00293462|O3|Outcome|Arm III: Salt & Soda Switched to GM-CSF (SG)|Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
1201989|NCT00293462|O2|Outcome|Arm II: Salt & Soda Group (SS)|Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
1201990|NCT00293462|O1|Outcome|Arm I: GM-CSF Group (GG)|Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
1201991|NCT00293462|O3|Outcome|Arm III: Salt & Soda Switched to GM-CSF (SG)|Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
1201992|NCT00293462|O2|Outcome|Arm II: Salt & Soda Group (SS)|Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
1201993|NCT00293462|O1|Outcome|Arm I: GM-CSF Group (GG)|Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
1201994|NCT00293462|O3|Outcome|Arm III: Salt & Soda Switched to GM-CSF (SG)|Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
1201995|NCT00293462|O2|Outcome|Arm II: Salt & Soda Group (SS)|Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
1201996|NCT00293462|O1|Outcome|Arm I: GM-CSF Group (GG)|Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
1201997|NCT00293462|O2|Outcome|Arm II: Salt & Soda Group (SS)|Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
1201998|NCT00293462|O1|Outcome|Arm I: GM-CSF Group (GG)|Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
1201999|NCT00293462|E3|Reported Event|Arm III: Salt & Soda Switched to GM-CSF (SG)|Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
1202000|NCT00293462|E2|Reported Event|Arm II: Salt & Soda Group (SS)|Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
1202001|NCT00293462|E1|Reported Event|Arm I: GM-CSF Group (GG)|Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
1202002|NCT00293384|B1|Baseline|Aprepitant, Dexamethasone, Cytoxan & Kytril|"Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.~Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.~Days 2 & 3: Aprepitant 80 mg once daily in the morning.~Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3~Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes~Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.~Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration."
1202003|NCT00293384|P1|Participant Flow|Aprepitant, Dexamethasone, Cytoxan & Kytril|"Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.~Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.~Days 2 & 3: Aprepitant 80 mg once daily in the morning.~Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3~Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes~Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.~Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration."
1202004|NCT00293384|O1|Outcome|Aprepitant, Dexamethasone, Cytoxan & Kytril|"Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.~Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.~Days 2 & 3: Aprepitant 80 mg once daily in the morning.~Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3~Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes~Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.~Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration."
1202005|NCT00293384|O1|Outcome|Aprepitant, Dexamethasone, Cytoxan & Kytril|"Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.~Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.~Days 2 & 3: Aprepitant 80 mg once daily in the morning.~Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3~Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes~Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.~Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration."
1202006|NCT00293384|O1|Outcome|Aprepitant, Dexamethasone, Cytoxan & Kytril|"Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.~Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.~Days 2 & 3: Aprepitant 80 mg once daily in the morning.~Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3~Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes~Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.~Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration."
1202140|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
1202007|NCT00293384|O1|Outcome|Aprepitant, Dexamethasone, Cytoxan & Kytril|"Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.~Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.~Days 2 & 3: Aprepitant 80 mg once daily in the morning.~Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3~Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes~Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.~Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration."
1202008|NCT00293384|E1|Reported Event|Aprepitant, Dexamethasone, Cytoxan & Kytril|"Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.~Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.~Days 2 & 3: Aprepitant 80 mg once daily in the morning.~Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3~Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes~Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.~Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration."
1202009|NCT00293293|B3|Baseline|Total|Total of all reporting groups
1202010|NCT00293293|B2|Baseline|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
1202011|NCT00293293|B1|Baseline|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
1202012|NCT00293293|P2|Participant Flow|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
1202013|NCT00293293|P1|Participant Flow|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
1202014|NCT00293293|O2|Outcome|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
1202015|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
1202016|NCT00293293|O2|Outcome|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
1202017|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
1202018|NCT00293293|O2|Outcome|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
1202019|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
1202020|NCT00293293|O2|Outcome|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
1202021|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
1202022|NCT00293293|O2|Outcome|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
1202023|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
1202024|NCT00293293|O1|Outcome|Chemotherapy Plus CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
1202025|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
1202026|NCT00293293|O1|Outcome|Chemotherapy Plus CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
1202027|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
1202028|NCT00293293|O1|Outcome|Chemotherapy Plus CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
1202029|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
1202030|NCT00293293|O1|Outcome|Chemotherapy Plus CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
1202031|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
1202032|NCT00293293|O2|Outcome|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
1202033|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
1202034|NCT00293293|O2|Outcome|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
1202035|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
1202036|NCT00293293|E2|Reported Event|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
1202037|NCT00293293|E1|Reported Event|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
1202038|NCT00293267|B3|Baseline|Total|Total of all reporting groups
1202039|NCT00293267|B2|Baseline|Placebo + OBT|
1202040|NCT00293267|B1|Baseline|Raltegravir 400 mg b.i.d. + OBT|
1202041|NCT00293267|P2|Participant Flow|Placebo + OBT|
1202042|NCT00293267|P1|Participant Flow|Raltegravir 400 mg b.i.d. + OBT|
1202043|NCT00293267|O2|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
1202044|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
1202045|NCT00293267|O2|Outcome|Placebo + OBT|
1202046|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
1202047|NCT00293267|O2|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
1202048|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
1202049|NCT00293267|O2|Outcome|Placebo + OBT|
1202050|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
1202051|NCT00293267|O2|Outcome|Placebo + OBT|
1202052|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
1202053|NCT00293267|O2|Outcome|Placebo + OBT|
1202054|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
1202055|NCT00293267|O2|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
1202480|NCT00292461|O1|Outcome|Zonegran|once or twice daily orally for 16 weeks
1202056|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
1202057|NCT00293267|O2|Outcome|Placebo + OBT|
1202058|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
1202059|NCT00293267|O2|Outcome|Placebo + OBT|
1202060|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
1202061|NCT00293267|O2|Outcome|Placebo + OBT|
1202062|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
1202063|NCT00293267|O2|Outcome|Placebo + OBT|
1202064|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
1202065|NCT00293267|O2|Outcome|Placebo + OBT|
1202066|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
1202067|NCT00293267|O2|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
1202068|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
1202069|NCT00293267|O2|Outcome|Placebo + OBT|
1202070|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
1202071|NCT00293267|O2|Outcome|Placebo + OBT|
1202072|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
1202073|NCT00293267|O2|Outcome|Placebo + OBT|
1202074|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
1202075|NCT00293267|O2|Outcome|Placebo + OBT|
1202076|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
1202077|NCT00293267|E2|Reported Event|Placebo Plus OBT|Includes all participants initially randomized to placebo, including those without virologic failure who continued into the open-label phase at Week 156 and those who entered the OLPVF phase due to virologic failure. During either open-label phase up to Week 240, these participants continued to receive raltegravir 400 mg b.i.d. plus OBT.
1202078|NCT00293267|E1|Reported Event|Raltegravir 400 mg b.i.d Plus OBT|"Includes all participants initially randomized to raltegravir, including those without virologic failure who~continued into the open-label phase at Week 156 and those who entered the OLPVF phase due to virologic failure. During either open-label phase up to Week 240, these participants continued to receive raltegravir 400 mg b.i.d. plus OBT."
1202079|NCT00293254|B3|Baseline|Total|Total of all reporting groups
1202080|NCT00293254|B2|Baseline|Placebo + OBT|
1202081|NCT00293254|B1|Baseline|Raltegravir 400 mg b.i.d. + OBT|
1202082|NCT00293254|P2|Participant Flow|Placebo + OBT|
1202083|NCT00293254|P1|Participant Flow|Raltegravir 400 mg b.i.d. + OBT|
1202084|NCT00293254|O2|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
1202085|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d. plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
1202086|NCT00293254|O2|Outcome|Placebo + OBT|
1202087|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
1202088|NCT00293254|O2|Outcome|Placebo + OBT|
1202089|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
1202090|NCT00293254|O2|Outcome|Placebo + OBT|
1202091|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
1202092|NCT00293254|O2|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
1202093|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d. plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
1202094|NCT00293254|O2|Outcome|Placebo + OBT|
1202095|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
1202096|NCT00293254|O2|Outcome|Placebo + OBT|
1202097|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
1202098|NCT00293254|O2|Outcome|Placebo + OBT|
1202099|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
1202100|NCT00293254|O2|Outcome|Placebo + OBT|
1202101|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
1202102|NCT00293254|O2|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
1202103|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d. plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
1202104|NCT00293254|O2|Outcome|Placebo + OBT|
1202105|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
1202106|NCT00293254|O2|Outcome|Placebo + OBT|
1202107|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
1202108|NCT00293254|O2|Outcome|Placebo + OBT|
1202109|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
1202481|NCT00292461|O2|Outcome|Lamotrigine|once daily orally for 16 weeks
1202482|NCT00292461|O1|Outcome|Zonegran|once or twice daily orally for 16 weeks
1202110|NCT00293254|O2|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
1202111|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d. plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
1202112|NCT00293254|O2|Outcome|Placebo + OBT|
1202113|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
1202114|NCT00293254|O2|Outcome|Placebo + OBT|
1202115|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
1202116|NCT00293254|O2|Outcome|Placebo + OBT|
1202117|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
1202118|NCT00293254|E2|Reported Event|Placebo Plus OBT|Includes all participants initially randomized to placebo, including those without virologic failure who continued into the open-label phase at Week 156 and those who entered the OLPVF phase due to virologic failure. During either open-label phase up to Week 240, these participants continued to receive raltegravir 400 mg b.i.d. plus OBT.
1202119|NCT00293254|E1|Reported Event|Raltegravir 400 mg b.i.d. Plus OBT|"Includes all participants initially randomized to raltegravir, including those without virologic failure who~continued into the open-label phase at Week 156 and those who entered the OLPVF phase due to virologic failure. During either open-label phase up to Week 240, these participants continued to receive raltegravir 400 mg b.i.d. plus OBT."
1202120|NCT00293241|B3|Baseline|Total|Total of all reporting groups
1202121|NCT00293241|B2|Baseline|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
1202122|NCT00293241|B1|Baseline|MVP ON|Managed Ventricular Pacing programmed on
1202123|NCT00293241|P2|Participant Flow|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
1202124|NCT00293241|P1|Participant Flow|MVP ON|Managed Ventricular Pacing programmed on
1202125|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
1202126|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
1202127|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
1202128|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
1202129|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
1202130|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
1202131|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
1202132|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
1202133|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
1202134|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
1202135|NCT00293241|O2|Outcome|MVP OFF|"Managed Ventricular Pacing programmed off: conventional pacing~Managed Ventricular Pacing programmed ON/OFF: Device programming"
1202136|NCT00293241|O1|Outcome|MVP ON|"Managed Ventricular Pacing programmed on~Managed Ventricular Pacing programmed ON/OFF: Device programming"
1202137|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
1202138|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
1202146|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
1202147|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
1202148|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
1202149|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
1202150|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
1202151|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
1202152|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
1202153|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
1202154|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
1202155|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
1202156|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
1202157|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
1202158|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
1202159|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
1202160|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
1202161|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
1202162|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
1202163|NCT00293241|E2|Reported Event|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
1202164|NCT00293241|E1|Reported Event|MVP ON|Managed Ventricular Pacing programmed on
1202165|NCT00292227|B3|Baseline|Total|Total of all reporting groups
1202166|NCT00292227|B2|Baseline|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202167|NCT00292227|B1|Baseline|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202168|NCT00292227|P3|Participant Flow|Placebo Patch (Infusion: Placebo-Moxifloxacin)|Placebo Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule. Placebo saline solution 250 mL infused over 1 hour on Day 32. Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour on Day 39.
1202169|NCT00292227|P2|Participant Flow|Placebo Patch (Infusion: Moxifloxacin-Placebo)|Placebo Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule. Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour on Day 32. Placebo saline solution 250 mL infused over 1 hour on Day 39.
1202170|NCT00292227|P1|Participant Flow|Rotigotine Patch (Infusion: Placebo-Placebo)|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule. Placebo saline solution 250 mL infused over 1 hour on Day 32 and on Day 39.
1202171|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
1202172|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
1202173|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
1202174|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
1202175|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
1202176|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
1202177|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
1202178|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
1202179|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
1202180|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
1202181|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
1202182|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
1202183|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
1202184|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
1202185|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
1202186|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
1202187|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
1202188|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
1202189|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
1202190|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
1202191|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
1202192|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
1202193|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
1202194|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
1202195|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
1202196|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
1202197|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202198|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202199|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202200|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202201|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202202|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202203|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202204|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202205|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202206|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202207|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202208|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202209|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202210|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202211|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202212|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202483|NCT00292461|E2|Reported Event|Lamotrigine|once daily orally for 16 weeks
1202213|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202214|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202215|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202216|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202217|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202218|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202219|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202220|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202221|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202222|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202223|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202224|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202225|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202226|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202227|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202228|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202229|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202230|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202231|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202232|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202233|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202234|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202235|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202236|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202237|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202238|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202239|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202240|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202241|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202242|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202243|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202244|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202245|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202246|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202247|NCT00292227|E2|Reported Event|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202248|NCT00292227|E1|Reported Event|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
1202249|NCT00292188|B3|Baseline|Total|Total of all reporting groups
1202250|NCT00292188|B2|Baseline|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
1202484|NCT00292461|E1|Reported Event|Zonegran|once or twice daily orally for 16 weeks
1202485|NCT00291876|B1|Baseline|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
1202251|NCT00292188|B1|Baseline|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
1202252|NCT00292188|P3|Participant Flow|Double-Blind Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
1202253|NCT00292188|P2|Participant Flow|Double-Blind Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
1202254|NCT00292188|P1|Participant Flow|Single-Blind Placebo|All subjects received placebo capsules for the 2-week screening period, subjects were then randomized to placebo or pregabalin treatment.
1202255|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
1202256|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
1202257|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
1202258|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
1202259|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
1202260|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
1202261|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
1202262|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
1202263|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
1202763|NCT00290732|O1|Outcome|Intraductal Arm- 0 mg PLD|Participants received intraductal administration of dextrose prior to conventional surgery for breast cancer.
1202264|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
1202265|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
1202266|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
1202267|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
1202268|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
1202269|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
1202270|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
1202271|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
1202486|NCT00291876|P1|Participant Flow|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
1202602|NCT00291187|P1|Participant Flow|Placebo|taken orally 30 minutes prior to bedtime
1202272|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
1202273|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
1202274|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
1202275|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
1202276|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
1202277|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
1202278|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
1202279|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
1202280|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
1202281|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
1202282|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
1202283|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
1202284|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
1202285|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
1202286|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
1202287|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
1202288|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
1202289|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
1202290|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
1202291|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
1202292|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
1202293|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
1202294|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
1202295|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
1202296|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
1202297|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
1202298|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
1202299|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
1202300|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
1202301|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
1202302|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
1202303|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
1202304|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
1202305|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
1202306|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
1202307|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
1202308|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
1202309|NCT00292188|E3|Reported Event|Double-Blind Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
1202310|NCT00292188|E2|Reported Event|Double-Blind Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
1202311|NCT00292188|E1|Reported Event|Single-Blind Placebo|All subjects received placebo capsules for the 2-week screening period, subjects were then randomized to placebo or pregabalin treatment.
1202312|NCT00292162|B3|Baseline|Total|Total of all reporting groups
1202313|NCT00292162|B2|Baseline|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
1202314|NCT00292162|B1|Baseline|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
1202315|NCT00292162|P2|Participant Flow|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
1202487|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
1202316|NCT00292162|P1|Participant Flow|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
1202317|NCT00292162|O2|Outcome|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
1202318|NCT00292162|O1|Outcome|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
1202319|NCT00292162|O2|Outcome|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
1202320|NCT00292162|O1|Outcome|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
1202321|NCT00292162|O2|Outcome|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
1202322|NCT00292162|O1|Outcome|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
1202323|NCT00292162|O2|Outcome|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
1202324|NCT00292162|O1|Outcome|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
1202325|NCT00292162|O2|Outcome|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
1202326|NCT00292162|O1|Outcome|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
1202327|NCT00292162|O2|Outcome|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
1202328|NCT00292162|O1|Outcome|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
1203755|NCT00288704|O2|Outcome|Rilonacept 160 mg|
1202329|NCT00292162|E2|Reported Event|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
1202330|NCT00292162|E1|Reported Event|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
1202331|NCT00293059|B3|Baseline|Total|Total of all reporting groups
1202332|NCT00293059|B2|Baseline|Placebo|Matching placebo to be taken orally daily
1202333|NCT00293059|B1|Baseline|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202334|NCT00293059|P2|Participant Flow|Placebo|Matching placebo to be taken orally daily
1202335|NCT00293059|P1|Participant Flow|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202336|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202337|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202338|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202488|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
1202489|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
1202339|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202340|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202341|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202342|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202343|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202344|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202345|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202346|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202347|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202348|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202349|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202350|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202351|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202352|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202353|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202354|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202355|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202356|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202357|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202358|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202359|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202360|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202361|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202362|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202990|NCT00289978|E3|Reported Event|Placebo|Patients self-administered a fingolimod placebo capsule orally once daily.
1202363|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202364|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202365|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202366|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202367|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202368|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202369|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202370|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202371|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202372|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202594|NCT00291187|B5|Baseline|Total|Total of all reporting groups
1202373|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202374|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202375|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202376|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202377|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202378|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202379|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202380|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202381|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202382|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202383|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202384|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202385|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202386|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202387|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202388|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202389|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202390|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202391|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202392|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202393|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202394|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202395|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202396|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202518|NCT00291655|E1|Reported Event|Levetiracetam Open- Label Treatment|Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
1202397|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202398|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202399|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202400|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202401|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202402|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202403|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202404|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202405|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202406|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202407|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202408|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202409|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202410|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202411|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202412|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202413|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202414|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202415|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202416|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202417|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202418|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202419|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202420|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202421|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202422|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202423|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202424|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202425|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202426|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202427|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202428|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202429|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202430|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202672|NCT00291018|O1|Outcome|ProDisc-C|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7~Total Disc Replacement~Randomized Group"
1202431|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202432|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202433|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202434|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202435|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202436|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202437|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202438|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202439|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202440|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202441|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202442|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
1202443|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202444|NCT00293059|E2|Reported Event|Placebo|Matching placebo to be taken orally daily
1202445|NCT00293059|E1|Reported Event|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
1202446|NCT00293020|B1|Baseline|Open Label Fentanyl Treatment|BioErodible Muco Adhesive(BEMA) Fentanyl
1202447|NCT00293020|P1|Participant Flow|Open Label Fentanyl Treatment|BioErodible Muco Adhesive(BEMA) Fentanyl
1202448|NCT00293020|O1|Outcome|Open Label Fentanyl Treatment|BioErodible Muco Adhesive(BEMA) Fentanyl
1202449|NCT00293020|E1|Reported Event|Open Label Fentanyl Treatment|BioErodible Muco Adhesive(BEMA) Fentanyl
1202450|NCT00292981|B1|Baseline|C1 Esterase Inhibitor|
1202451|NCT00292981|P1|Participant Flow|C1 Esterase Inhibitor|
1202452|NCT00292981|O1|Outcome|C1 Esterase Inhibitor|
1202453|NCT00292981|O1|Outcome|C1 Esterase Inhibitor|
1202454|NCT00292981|O1|Outcome|C1 Esterase Inhibitor|
1202455|NCT00292981|O1|Outcome|C1 Esterase Inhibitor|
1202456|NCT00292981|E1|Reported Event|C1 Esterase Inhibitor|
1202457|NCT00292591|B4|Baseline|Total|Total of all reporting groups
1202458|NCT00292591|B3|Baseline|Cholecalciferol 4000 IU|"Experimental group receiving 4000 IU/day cholecalciferol~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
1202459|NCT00292591|B2|Baseline|Cholecalciferol 2000 IU|"Experimental group receiving 2000 IU total vitamin D3/day.~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
1202460|NCT00292591|B1|Baseline|Cholecalciferol-400 IU|"Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
1202461|NCT00292591|P3|Participant Flow|Cholecalciferol 4000 IU|"Experimental group receiving 4000 IU/day cholecalciferol~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
1202462|NCT00292591|P2|Participant Flow|Cholecalciferol 2000 IU|"Experimental group receiving 2000 IU total vitamin D3/day.~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
1202463|NCT00292591|P1|Participant Flow|Cholecalciferol-400 IU|"Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
1202464|NCT00292591|O3|Outcome|Cholecalciferol 4000 IU|"Experimental group receiving 4000 IU/day cholecalciferol~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
1202465|NCT00292591|O2|Outcome|Cholecalciferol 2000 IU|"Experimental group receiving 2000 IU total vitamin D3/day.~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
1202918|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202466|NCT00292591|O1|Outcome|Cholecalciferol-400 IU|"Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
1202467|NCT00292591|E3|Reported Event|Cholecalciferol 4000 IU|"Experimental group receiving 4000 IU/day cholecalciferol~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
1202468|NCT00292591|E2|Reported Event|Cholecalciferol 2000 IU|"Experimental group receiving 2000 IU total vitamin D3/day.~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
1202469|NCT00292591|E1|Reported Event|Cholecalciferol-400 IU|"Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
1202470|NCT00292461|B3|Baseline|Total|Total of all reporting groups
1202471|NCT00292461|B2|Baseline|Lamotrigine|once daily orally for 16 weeks
1202472|NCT00292461|B1|Baseline|Zonegran|once or twice daily orally for 16 weeks
1202473|NCT00292461|P2|Participant Flow|Lamotrigine|once daily orally for 16 weeks
1202474|NCT00292461|P1|Participant Flow|Zonegran|once or twice daily orally for 16 weeks
1202475|NCT00292461|O2|Outcome|Lamotrigine|once daily orally for 16 weeks
1202476|NCT00292461|O1|Outcome|Zonegran|once or twice daily orally for 16 weeks
1202490|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
1202491|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
1202492|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
1202493|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
1202494|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
1202495|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
1202496|NCT00291876|E1|Reported Event|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
1202497|NCT00291694|B3|Baseline|Total|Total of all reporting groups
1202498|NCT00291694|B2|Baseline|Placebo|Placebo for six months
1202499|NCT00291694|B1|Baseline|Celecoxib|Celecoxib for six months
1202500|NCT00291694|P2|Participant Flow|Celecoxib|Celecoxib for 12 months
1202501|NCT00291694|P1|Participant Flow|Placebo|Placebo for 12 months
1202502|NCT00291694|O2|Outcome|Placebo|"Matched blinded placebo twice daily for 12 months~placebo: placebo"
1202503|NCT00291694|O1|Outcome|Celecoxib|"Oral Celecoxib 400 mg twice daily for 12 months~celecoxib: Celecoxib 400 mg BID"
1202504|NCT00291694|O2|Outcome|Placebo|"Matched blinded placebo twice daily for 12 months~placebo: placebo"
1202505|NCT00291694|O1|Outcome|Celecoxib|"Oral Celecoxib 400 mg twice daily for 12 months~celecoxib: Celecoxib 400 mg BID"
1202506|NCT00291694|O2|Outcome|Placebo|"Matched blinded placebo twice daily for 12 months~placebo: placebo"
1202507|NCT00291694|O1|Outcome|Celecoxib|"Oral Celecoxib 400 mg twice daily for 12 months~celecoxib: Celecoxib 400 mg BID"
1202508|NCT00291694|O2|Outcome|Placebo|"Matched blinded placebo twice daily for 12 months~placebo: placebo"
1202509|NCT00291694|O1|Outcome|Celecoxib|"Oral Celecoxib 400 mg twice daily for 12 months~celecoxib: Celecoxib 400 mg BID"
1202510|NCT00291694|O2|Outcome|Placebo|Randomized to receive placebo daily for 12 months
1202511|NCT00291694|O1|Outcome|Celecoxib|Randomized to receive celecoxib daily for 12 months
1202512|NCT00291694|E2|Reported Event|Placebo|Randomized to receive palcebo daily for 12 months
1202513|NCT00291694|E1|Reported Event|Celecoxib|Randomized to receive celecoxib daily for 12 months
1202514|NCT00291655|B1|Baseline|Levetiracetam Open- Label Treatment|Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
1202515|NCT00291655|P1|Participant Flow|Levetiracetam Open- Label Treatment|Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
1202516|NCT00291655|O1|Outcome|Levetiracetam Open- Label Treatment|Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
1202517|NCT00291655|O1|Outcome|Levetiracetam Open- Label Treatment|Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
1203756|NCT00288704|O1|Outcome|Placebo|
1202519|NCT00291577|B1|Baseline|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
1202520|NCT00291577|P1|Participant Flow|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
1202521|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
1202522|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
1202523|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
1202524|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
1202525|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
1202526|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
1202595|NCT00291187|B4|Baseline|VEC-162 100 mg|100 mg taken orally 30 minutes prior to bedtime.
1202527|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
1202528|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
1202529|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
1202530|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
1202531|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
1202532|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
1202533|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
1202534|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
1202535|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
1202536|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
1202537|NCT00291577|E1|Reported Event|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
1202538|NCT00291551|B1|Baseline|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
1202539|NCT00291551|P1|Participant Flow|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
1202540|NCT00291551|O1|Outcome|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
1202541|NCT00291551|O1|Outcome|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
1202542|NCT00291551|O1|Outcome|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
1202543|NCT00291551|O1|Outcome|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
1202544|NCT00291551|O1|Outcome|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
1202545|NCT00291551|O1|Outcome|Non-randomized, Single Arm, Treatment|
1202546|NCT00291551|O1|Outcome|Non-randomized, Single Arm, Treatment|
1202547|NCT00291551|O1|Outcome|Non-randomized, Single Arm, Treatment|
1202548|NCT00291551|O1|Outcome|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
1202549|NCT00291551|O1|Outcome|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
1202550|NCT00291551|O1|Outcome|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
1202551|NCT00291551|O1|Outcome|Non-randomized, Single Arm, Treatment|
1202552|NCT00291551|E1|Reported Event|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
1202553|NCT00291330|B3|Baseline|Total|Total of all reporting groups
1202554|NCT00291330|B2|Baseline|Warfarin|PRN to maintain an INR of 2.0-3.0
1202555|NCT00291330|B1|Baseline|Dabigatran 150 mg|bid (twice daily) oral
1202556|NCT00291330|P2|Participant Flow|Warfarin|PRN to maintain an INR of 2.0-3.0
1202557|NCT00291330|P1|Participant Flow|Dabigatran 150 mg|bid (twice daily) oral
1202558|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
1202559|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
1202560|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
1202561|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
1202562|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
1202563|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
1202564|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
1202565|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
1202566|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
1202567|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
1202568|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
1202569|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
1202570|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
1202571|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
1202572|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
1202573|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
1202574|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
1202575|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
1202576|NCT00291330|E2|Reported Event|Warfarin|PRN to maintain an INR of 2.0-3.0
1202577|NCT00291330|E1|Reported Event|Dabigatran 150 mg|bid (twice daily) oral
1202631|NCT00291161|P1|Participant Flow|Veterans: Partners in Dementia Care Intervention|A two-person care coordinator team, one based at the VA and one based at the Alzheimer Association, provided telephone-based support to patients with dementia and their caregivers over a 12-month period. The team addressed medical and nonmedical needs through education, coaching, linkages to needed resources, and mobilization of an informal care network. The program consisted of an upfront assessment, development of care goals and action steps, and ongoing monitoring and intervention by the two coordinators, who communicated with each other regularly.
1203757|NCT00288704|O2|Outcome|Rilonacept 160 mg|
1202578|NCT00291317|B1|Baseline|FES Cycle Exercise|Participants exercised using functional electrical stimulation cycling (FES) using the RT 300 FES cycle (Restorative Therapies, Baltimore, MD). Stimulation rpm (45-50), pulse duration (250 μs), and frequency (33.3 Hz) were fixed. Amplitude ranged from 70-120mA, and average stim ranged from 16.50-29.7 μC. Participants were monitored for autonomic dysreflexia during training. Blood pressure and heart rate were monitored during the initial evaluation and the first session of cycling. Once it was established that there were no adverse physiological responses, ongoing blood pressure and heart rate monitoring did not continue for subsequent sessions. No participant experienced a dysreflexive episode in response to electrical stimulation during this study. Children were scheduled to attend three cycling sessions per week on non-consecutive days for up to 30 minutes (plus a 2 minute warm up and 30 second cool down) per session over a 9 month period.
1202579|NCT00291317|P1|Participant Flow|FES Cycle Exercise|Participants exercised using functional electrical stimulation cycling (FES) using the RT 300 FES cycle (Restorative Therapies, Baltimore, MD). Stimulation rpm (45-50), pulse duration (250 μs), and frequency (33.3 Hz) were fixed. Amplitude ranged from 70-120mA, and average stim ranged from 16.50-29.7 μC. Participants were monitored for autonomic dysreflexia during training. Blood pressure and heart rate were monitored during the initial evaluation and the first session of cycling. Once it was established that there were no adverse physiological responses, ongoing blood pressure and heart rate monitoring did not continue for subsequent sessions. No participant experienced a dysreflexive episode in response to electrical stimulation during this study. Children were scheduled to attend three cycling sessions per week on non-consecutive days for up to 30 minutes (plus a 2 minute warm up and 30 second cool down) per session over a 9 month period.
1202580|NCT00291317|O1|Outcome|DEXA|
1202581|NCT00291317|O1|Outcome|FES Cycle Exercise|Participants exercised using functional electrical stimulation cycling (FES) using the RT 300 FES cycle (Restorative Therapies, Baltimore, MD). Stimulation rpm (45-50), pulse duration (250 μs), and frequency (33.3 Hz) were fixed. Amplitude ranged from 70-120mA, and average stim ranged from 16.50-29.7 μC. Participants were monitored for autonomic dysreflexia during training. Blood pressure and heart rate were monitored during the initial evaluation and the first session of cycling. Once it was established that there were no adverse physiological responses, ongoing blood pressure and heart rate monitoring did not continue for subsequent sessions. No participant experienced a dysreflexive episode in response to electrical stimulation during this study. Children were scheduled to attend three cycling sessions per week on non-consecutive days for up to 30 minutes (plus a 2 minute warm up and 30 second cool down) per session over a 9 month period.
1202596|NCT00291187|B3|Baseline|VEC-162 50 mg|50 mg taken orally 30 minutes prior to bedtime.
1202597|NCT00291187|B2|Baseline|VEC-162 20 mg|20 mg taken orally 30 minutes prior to bedtime.
1202598|NCT00291187|B1|Baseline|Placebo|Taken orally 30 minutes prior to bedtime.
1202599|NCT00291187|P4|Participant Flow|VEC-162 100 mg|100 mg taken orally 30 minutes prior to bedtime
1202600|NCT00291187|P3|Participant Flow|VEC-162 50 mg|50 mg taken orally 30 minutes prior to bedtime
1202582|NCT00291317|E1|Reported Event|FES Cycle Exercise|Participants exercised using functional electrical stimulation cycling (FES) using the RT 300 FES cycle (Restorative Therapies, Baltimore, MD). Stimulation rpm (45-50), pulse duration (250 μs), and frequency (33.3 Hz) were fixed. Amplitude ranged from 70-120mA, and average stim ranged from 16.50-29.7 μC. Participants were monitored for autonomic dysreflexia during training. Blood pressure and heart rate were monitored during the initial evaluation and the first session of cycling. Once it was established that there were no adverse physiological responses, ongoing blood pressure and heart rate monitoring did not continue for subsequent sessions. No participant experienced a dysreflexive episode in response to electrical stimulation during this study. Children were scheduled to attend three cycling sessions per week on non-consecutive days for up to 30 minutes (plus a 2 minute warm up and 30 second cool down) per session over a 9 month period.
1202583|NCT00291226|B3|Baseline|Total|Total of all reporting groups
1202584|NCT00291226|B2|Baseline|Placebo Group|"Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or “sprinkles” (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing. Since earlier product testing by Glytech revealed that a few individuals did not like the somewhat granular texture of the sprinkles, subjects could switch to a second Glytech formulation, consisting of proprietary pre-flavored glycine or sugar powders to be dissolved in 8 ounces of water.~Placebo: Placebo"
1202585|NCT00291226|B1|Baseline|Glycine|"Glycine dosing was fixed at an initial dose of 0.2 g/kg q.h.s for 3 days, then 0.2 g/kg b.i.d. for 4 days, then 0.2 g/kg in the a.m. and 0.4 g/kg in the p.m. for 4 days, and finally 0.4 g/kg b.i.d. Subjects weighing > 100 kg were limited to a total daily dose of 80 g daily.~Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or “sprinkles” (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing.~Glycine: Glycine 0.4 g/kg bid"
1202586|NCT00291226|P2|Participant Flow|Placebo Group|Glycine and placebo dosing group.
1202587|NCT00291226|P1|Participant Flow|Glycine|Glycine dosing group.
1202588|NCT00291226|O2|Outcome|Placebo Group|"Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or “sprinkles” (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing. Since earlier product testing by Glytech revealed that a few individuals did not like the somewhat granular texture of the sprinkles, subjects could switch to a second Glytech formulation, consisting of proprietary pre-flavored glycine or sugar powders to be dissolved in 8 ounces of water.~Placebo: Placebo"
1202589|NCT00291226|O1|Outcome|Glycine|"Glycine dosing was fixed at an initial dose of 0.2 g/kg q.h.s for 3 days, then 0.2 g/kg b.i.d. for 4 days, then 0.2 g/kg in the a.m. and 0.4 g/kg in the p.m. for 4 days, and finally 0.4 g/kg b.i.d. Subjects weighing > 100 kg were limited to a total daily dose of 80 g daily.~Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or “sprinkles” (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing.~Glycine: Glycine 0.4 g/kg bid"
1202632|NCT00291161|O2|Outcome|Usual Care Comparison|Patients and caregivers were provided usual care and an educational booklet on dementia
1202673|NCT00291018|O3|Outcome|ProDisc-C Continued Access|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7~Total Disc Replacement~Non-Randomized Group"
1202590|NCT00291226|O2|Outcome|Placebo Group|"Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or “sprinkles” (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing. Since earlier product testing by Glytech revealed that a few individuals did not like the somewhat granular texture of the sprinkles, subjects could switch to a second Glytech formulation, consisting of proprietary pre-flavored glycine or sugar powders to be dissolved in 8 ounces of water.~Placebo: Placebo"
1202591|NCT00291226|O1|Outcome|Glycine|"Glycine dosing was fixed at an initial dose of 0.2 g/kg q.h.s for 3 days, then 0.2 g/kg b.i.d. for 4 days, then 0.2 g/kg in the a.m. and 0.4 g/kg in the p.m. for 4 days, and finally 0.4 g/kg b.i.d. Subjects weighing > 100 kg were limited to a total daily dose of 80 g daily.~Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or “sprinkles” (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing.~Glycine: Glycine 0.4 g/kg bid"
1202592|NCT00291226|E2|Reported Event|Placebo Group|"Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or “sprinkles” (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing. Since earlier product testing by Glytech revealed that a few individuals did not like the somewhat granular texture of the sprinkles, subjects could switch to a second Glytech formulation, consisting of proprietary pre-flavored glycine or sugar powders to be dissolved in 8 ounces of water.~Placebo: Placebo"
1202593|NCT00291226|E1|Reported Event|Glycine|"Glycine dosing was fixed at an initial dose of 0.2 g/kg q.h.s for 3 days, then 0.2 g/kg b.i.d. for 4 days, then 0.2 g/kg in the a.m. and 0.4 g/kg in the p.m. for 4 days, and finally 0.4 g/kg b.i.d. Subjects weighing > 100 kg were limited to a total daily dose of 80 g daily.~Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or “sprinkles” (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing.~Glycine: Glycine 0.4 g/kg bid"
1202603|NCT00291187|O4|Outcome|VEC-162 100 mg|100 mg taken orally 30 minutes prior to bedtime.
1202604|NCT00291187|O3|Outcome|VEC-162 50 mg|50 mg taken orally 30 minutes prior to bedtime.
1202605|NCT00291187|O2|Outcome|VEC-162 20 mg|20 mg taken orally 30 minutes prior to bedtime.
1202606|NCT00291187|O1|Outcome|Placebo|Taken orally 30 minutes prior to bedtime
1202607|NCT00291187|O4|Outcome|VEC-162 100 mg|100 mg taken orally 30 minutes prior to bedtime.
1202608|NCT00291187|O3|Outcome|VEC-162 50 mg|50 mg taken orally 30 minutes prior to bedtime.
1202609|NCT00291187|O2|Outcome|VEC-162 20 mg|20 mg taken orally 30 minutes prior to bedtime.
1202610|NCT00291187|O1|Outcome|Placebo|Taken orally 30 minutes prior to bedtime.
1202611|NCT00291187|O4|Outcome|VEC-162 100 mg|100 mg taken orally 30 minutes prior to bedtime
1202612|NCT00291187|O3|Outcome|VEC-162 50 mg|50 mg taken orally 30 minutes prior to bedtime
1202613|NCT00291187|O2|Outcome|VEC-162 20 mg|20 mg taken orally 30 minutes prior to bedtime
1202614|NCT00291187|O1|Outcome|Placebo|Taken orally 30 minutes prior to bedtime.
1202615|NCT00291187|O4|Outcome|VEC-162 100 mg|100 mg taken orally 30 minutes prior to bedtime.
1202616|NCT00291187|O3|Outcome|VEC-162 50 mg|50 mg taken orally 30 minutes prior to bedtime.
1202617|NCT00291187|O2|Outcome|VEC-162 20 mg|20 mg taken orally 30 minutes prior to bedtime.
1202618|NCT00291187|O1|Outcome|Placebo|Taken orally 30 minutes prior to bedtime.
1202619|NCT00291187|E4|Reported Event|VEC-162 100 mg|100 mg taken orally 30 minutes prior to bedtime.
1202620|NCT00291187|E3|Reported Event|VEC-162 50 mg|50 mg taken orally 30 minutes prior to bedtime.
1202621|NCT00291187|E2|Reported Event|VEC-162 20 mg|20 mg taken orally 30 minutes prior to bedtime.
1202622|NCT00291187|E1|Reported Event|Placebo|Taken orally 30 minutes prior to bedtime.
1202623|NCT00291161|B5|Baseline|Total|Total of all reporting groups
1202624|NCT00291161|B4|Baseline|Caregivers-Usual Care Comparison Group|Caregivers to veterans with diagnosed dementia receiving educational materials and usual care
1202625|NCT00291161|B3|Baseline|Caregivers-PDC Group|Caregivers to veterans with diagnosed dementia receiving the PDC Intervention
1202626|NCT00291161|B2|Baseline|Veterans-Usual Care Comparison Group|Veterans with diagnosed dementia receiving educational materials and usual care
1202627|NCT00291161|B1|Baseline|Veterans-PDC Group|Veterans with diagnosed dementia receiving the PDC Intervention
1202628|NCT00291161|P4|Participant Flow|Caregivers: Usual Care Comparison|Caregivers of the Veterans assigned to the Usual Care Comparison
1202629|NCT00291161|P3|Participant Flow|Caregivers: Partners in Dementia Care Intervention|Caregivers for Veterans assigned to the Partners in Dementia Care Intervention
1202630|NCT00291161|P2|Participant Flow|Veterans: Usual Care Comparison|Patients and caregivers were provided usual care and an educational booklet on dementia
1202674|NCT00291018|O2|Outcome|Control|"Anterior Cervical Discectomy and Fusion~ACDF~Randomized Group"
1203758|NCT00288704|O1|Outcome|Placebo|
1202633|NCT00291161|O1|Outcome|Partners in Dementia Care Intervention|A two-person care coordinator team, one based at the VA and one based at the Alzheimer Association, provided telephone-based support to patients with dementia and their caregivers over a 12-month period. The team addressed medical and nonmedical needs through education, coaching, linkages to needed resources, and mobilization of an informal care network. The program consisted of an upfront assessment, development of care goals and action steps, and ongoing monitoring and intervention by the two coordinators, who communicated with each other regularly.
1202634|NCT00291161|O2|Outcome|Caregivers: Usual Care Comparison|Patients and caregivers were provided usual care and an educational booklet on dementia
1202635|NCT00291161|O1|Outcome|Caregivers: Partners in Dementia Care Intervention|A two-person care coordinator team, one based at the VA and one based at the Alzheimer Association, provided telephone-based support to patients with dementia and their caregivers over a 12-month period. The team addressed medical and nonmedical needs through education, coaching, linkages to needed resources, and mobilization of an informal care network. The program consisted of an upfront assessment, development of care goals and action steps, and ongoing monitoring and intervention by the two coordinators, who communicated with each other regularly.
1202636|NCT00291161|E2|Reported Event|Veterans-Usual Care Comparison Group|Veterans with diagnosed dementia receiving educational materials and usual care
1202637|NCT00291161|E1|Reported Event|Veterans-PDC Group|Veterans with diagnosed dementia receiving the PDC Intervention
1202638|NCT00291135|B1|Baseline|Letrozole|Letrozole, 2.5 mg daily for six months
1202639|NCT00291135|P1|Participant Flow|Letrozole|Letrozole, 2.5 mg daily for six months
1202640|NCT00291135|O1|Outcome|Letrozole|Letrozole, 2.5 mg daily for six months
1202641|NCT00291135|E1|Reported Event|Letrozole|Letrozole, 2.5 mg daily for six months
1202642|NCT00291018|B4|Baseline|Total|Total of all reporting groups
1202643|NCT00291018|B3|Baseline|ProDisc-C Continued Access|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7~Total Disc Replacement~Non-Randomized"
1202644|NCT00291018|B2|Baseline|Control|"Anterior Cervical Discectomy and Fusion~ACDF~Randomized"
1202645|NCT00291018|B1|Baseline|ProDisc-C|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7~Total Disc Replacement~Randomized"
1202646|NCT00291018|P3|Participant Flow|ProDisc-C Continued Access|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7~Total Disc Replacement~Non-Randomized Group"
1202647|NCT00291018|P2|Participant Flow|Control|"Anterior Cervical Discectomy and Fusion~ACDF~Randomized Group"
1202648|NCT00291018|P1|Participant Flow|ProDisc-C|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7~Total Disc Replacement~Randomized Group"
1202649|NCT00291018|O3|Outcome|ProDisc-C Continued Access|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7~Total Disc Replacement~Non-Randomized Group"
1202650|NCT00291018|O2|Outcome|Control|"Anterior Cervical Discectomy and Fusion~ACDF~Randomized Group"
1202651|NCT00291018|O1|Outcome|ProDisc-C|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7~Total Disc Replacement~Randomized Group"
1202652|NCT00291018|O3|Outcome|ProDisc-C Continued Access|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7~Total Disc Replacement~Non-Randomized Group"
1202653|NCT00291018|O2|Outcome|Control|"Anterior Cervical Discectomy and Fusion~ACDF~Randomized Group"
1202654|NCT00291018|O1|Outcome|ProDisc-C|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7~Total Disc Replacement~Randomized Group"
1202655|NCT00291018|O3|Outcome|ProDisc-C Continued Access|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7~Total Disc Replacement~Non-Randomized Group"
1202656|NCT00291018|O2|Outcome|Control|"Anterior Cervical Discectomy and Fusion~ACDF~Randomized Group"
1202657|NCT00291018|O1|Outcome|ProDisc-C|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7~Total Disc Replacement~Randomized Group"
1202658|NCT00291018|O3|Outcome|ProDisc-C Continued Access|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7~Total Disc Replacement~Non-Randomized Group"
1202659|NCT00291018|O2|Outcome|Control|"Anterior Cervical Discectomy and Fusion~ACDF~Randomized Group"
1202660|NCT00291018|O1|Outcome|ProDisc-C|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7~Total Disc Replacement~Randomized Group"
1202661|NCT00291018|O3|Outcome|ProDisc-C Continued Access|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7~Total Disc Replacement~Non-Randomized Group"
1202662|NCT00291018|O2|Outcome|Control|"Anterior Cervical Discectomy and Fusion~ACDF~Randomized Group"
1202663|NCT00291018|O1|Outcome|ProDisc-C|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7~Total Disc Replacement~Randomized Group"
1202664|NCT00291018|O3|Outcome|ProDisc-C Continued Access|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7~Total Disc Replacement~Non-Randomized Group"
1202665|NCT00291018|O2|Outcome|Control|"Anterior Cervical Discectomy and Fusion~ACDF~Randomized Group"
1202666|NCT00291018|O1|Outcome|ProDisc-C|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7~Total Disc Replacement~Randomized Group"
1202667|NCT00291018|O3|Outcome|ProDisc-C Continued Access|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7~Total Disc Replacement~Non-Randomized Group"
1202668|NCT00291018|O2|Outcome|Control|"Anterior Cervical Discectomy and Fusion~ACDF~Randomized Group"
1202669|NCT00291018|O1|Outcome|ProDisc-C|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7~Total Disc Replacement~Randomized Group"
1202670|NCT00291018|O3|Outcome|ProDisc-C Continued Access|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7~Total Disc Replacement~Non-Randomized Group"
1202671|NCT00291018|O2|Outcome|Control|"Anterior Cervical Discectomy and Fusion~ACDF~Randomized Group"
1202675|NCT00291018|O1|Outcome|ProDisc-C|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7~Total Disc Replacement~Randomized Group"
1202676|NCT00291018|O3|Outcome|ProDisc-C Continued Access|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7~Total Disc Replacement~Non-Randomized Group"
1202677|NCT00291018|O2|Outcome|Control|"Anterior Cervical Discectomy and Fusion~ACDF~Randomized Group"
1202678|NCT00291018|O1|Outcome|ProDisc-C|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7~Total Disc Replacement~Randomized Group"
1202679|NCT00291018|O3|Outcome|ProDisc-C Continued Access|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7~Total Disc Replacement~Non-Randomized"
1202680|NCT00291018|O2|Outcome|Control|"Anterior Cervical Discectomy and Fusion~ACDF~Randomized"
1202681|NCT00291018|O1|Outcome|ProDisc-C|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7~Total Disc Replacement~Randomized"
1202682|NCT00291018|E3|Reported Event|ProDisc-C Continued Access|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7~Total Disc Replacement~Non-Randomized Group"
1202683|NCT00291018|E2|Reported Event|Control|"Anterior Cervical Discectomy and Fusion~ACDF~Randomized Group"
1202684|NCT00291018|E1|Reported Event|ProDisc-C|"ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7~Total Disc Replacement~Randomized Group"
1202685|NCT00290888|B3|Baseline|Total|Total of all reporting groups
1202686|NCT00290888|B2|Baseline|Arthroscopic Rotator Cuff Repair With Acromioplasty|Arthroscopic rotator cuff repair with acromioplasty (ACR-A)
1202687|NCT00290888|B1|Baseline|Arthroscopic Rotator Cuff Repair Without Acromioplasty|Arthroscopic rotator cuff repair without acromioplasty (ACR)
1202688|NCT00290888|P2|Participant Flow|Arthorscopic Rotator Cuff Repair With Acromioplasty|"ACR-A~Acromioplasty"
1202689|NCT00290888|P1|Participant Flow|Arthroscopic Rotator Cuff Repair Without Acromioplasty|"ACR~Acromioplasty"
1202690|NCT00290888|O2|Outcome|Arthorscopic Rotator Cuff Repair With Acromioplasty|ACR-A Acromioplasty
1202691|NCT00290888|O1|Outcome|Arthroscopic Rotator Cuff Repair Without Acromioplasty|ACR
1202692|NCT00290888|O2|Outcome|Arthroscopic Rotator Cuff Repair With Acromioplasty|"ACR-A~Acromioplasty"
1202693|NCT00290888|O1|Outcome|Arthroscopic Rotator Cuff Repair Without Acromioplasty|ACR
1202694|NCT00290888|E2|Reported Event|Arthroscopic Rotator Cuff Repair With Acromioplasty|"ACR-A~Acromioplasty"
1202695|NCT00290888|E1|Reported Event|Arthroscopic Rotator Cuff Repair Without Acromioplasty|ACR
1202696|NCT00290810|B1|Baseline|Treatment (Monoclonal Antibody Therapy)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1202697|NCT00290810|P1|Participant Flow|Treatment (Monoclonal Antibody Therapy)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1202740|NCT00290758|O1|Outcome|Arm A (Genistein)|Patients received oral genistein once daily for 6 months
1202698|NCT00290810|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1202699|NCT00290810|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1202700|NCT00290810|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1202701|NCT00290810|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1202702|NCT00290810|E1|Reported Event|Treatment (Monoclonal Antibody Therapy)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1202703|NCT00290771|B3|Baseline|Total|Total of all reporting groups
1202704|NCT00290771|B2|Baseline|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
1202705|NCT00290771|B1|Baseline|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
1202706|NCT00290771|P2|Participant Flow|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
1202707|NCT00290771|P1|Participant Flow|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
1202708|NCT00290771|O3|Outcome|All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg|Patients took either imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal or imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals.
1202709|NCT00290771|O2|Outcome|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
1202710|NCT00290771|O1|Outcome|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
1202711|NCT00290771|O3|Outcome|All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg|Patients took either imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal or imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals.
1202712|NCT00290771|O2|Outcome|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
1202713|NCT00290771|O1|Outcome|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
1202714|NCT00290771|O3|Outcome|All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg|Patients took either imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal or imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals.
1202715|NCT00290771|O2|Outcome|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
1202741|NCT00290758|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo once daily for up to 6 months.
1202716|NCT00290771|O1|Outcome|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
1202717|NCT00290771|O3|Outcome|All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg|Patients took either imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal or imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals.
1202718|NCT00290771|O2|Outcome|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
1202719|NCT00290771|O1|Outcome|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
1202720|NCT00290771|O3|Outcome|All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg|Patients took either imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal or imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals.
1202721|NCT00290771|O2|Outcome|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
1202722|NCT00290771|O1|Outcome|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
1202723|NCT00290771|O3|Outcome|All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg|Patients took either imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal or imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals.
1202724|NCT00290771|O2|Outcome|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
1202725|NCT00290771|O1|Outcome|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
1202726|NCT00290771|E2|Reported Event|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
1202727|NCT00290771|E1|Reported Event|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
1202728|NCT00290758|B3|Baseline|Total|Total of all reporting groups
1202729|NCT00290758|B2|Baseline|Arm B|Patients receive oral placebo once daily for up to 6 months.
1202730|NCT00290758|B1|Baseline|Arm A|Patients receive oral genistein once daily for up to 6 months.
1202731|NCT00290758|P2|Participant Flow|Arm B (Placebo)|Patients received oral placebo once daily for 6 months
1202732|NCT00290758|P1|Participant Flow|Arm A (Genistein)|Patients received oral genistein once daily for 6 months
1202733|NCT00290758|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo once daily for up to 6 months.
1202734|NCT00290758|O1|Outcome|Arm I (Genistein)|Patients receive oral genistein once daily for up to 6 months.
1202735|NCT00290758|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo once daily for up to 6 months.
1202736|NCT00290758|O1|Outcome|Arm I (Genistein)|Patients receive oral genistein once daily for up to 6 months.
1202737|NCT00290758|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for up to 6 months.
1202738|NCT00290758|O1|Outcome|Arm A (Genistein)|Patients receive oral genistein once daily for up to 6 months.
1202739|NCT00290758|O2|Outcome|Arm B (Placebo)|Patients received oral placebo once daily for 6 months
1202742|NCT00290758|O1|Outcome|Arm I (Genistein)|Patients receive oral genistein once daily for up to 6 months.
1202743|NCT00290758|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for up to 6 months.
1202744|NCT00290758|O1|Outcome|Arm A (Genistein)|Patients receive oral genistein once daily for up to 6 months.
1202745|NCT00290758|O2|Outcome|Arm B (Placebo)|Patients received oral placebo once daily for 6 months
1202746|NCT00290758|O1|Outcome|Arm A (Genistein)|Patients received oral genistein once daily for 6 months
1202747|NCT00290758|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for up to 6 months.
1202748|NCT00290758|O1|Outcome|Arm A (Genistein)|Patients receive oral genistein once daily for up to 6 months.
1202749|NCT00290758|E2|Reported Event|Arm B (Placebo)|Patients take oral placebo once daily for up to 6 months.
1202750|NCT00290758|E1|Reported Event|Arm A (Genistein)|Patients take oral genistein once daily for up to 6 months.
1202751|NCT00290732|B3|Baseline|Total|Total of all reporting groups
1202752|NCT00290732|B2|Baseline|Intravenous Arm|Participants receiving standard intravenous administration of pegylated liposomal doxorubicin prior to breast biopsy for drug concentrations.
1202753|NCT00290732|B1|Baseline|Intraductal Arm|Participants received intraductal administration of dextrose or dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD) prior to conventional surgery for breast cancer.
1202754|NCT00290732|P5|Participant Flow|Intravenous Arm|Participants receiving standard intravenous administration of pegylated liposomal doxorubicin prior to breast biopsy for drug concentrations.
1202755|NCT00290732|P4|Participant Flow|Intraductal Arm- 10 mg PLD|Participants received intraductal administration of pegylated liposomal doxorubicin hydrochloride (or PLD), 10 mg, prior to conventional surgery for breast cancer.
1202756|NCT00290732|P3|Participant Flow|Intraductal Arm- 5 mg PLD|Participants received intraductal administration of pegylated liposomal doxorubicin hydrochloride (or PLD), 5 mg, prior to conventional surgery for breast cancer.
1202757|NCT00290732|P2|Participant Flow|Intraductal Arm- 2 mg PLD|Participants received intraductal administration of pegylated liposomal doxorubicin hydrochloride (or PLD), 2 mg, prior to conventional surgery for breast cancer.
1202758|NCT00290732|P1|Participant Flow|Intraductal Arm- 0 mg PLD|Participants received intraductal administration of dextrose prior to conventional surgery for breast cancer.
1202759|NCT00290732|O5|Outcome|Intravenous Arm|Participants receiving standard intravenous administration of pegylated liposomal doxorubicin prior to breast biopsy for drug concentrations.
1202760|NCT00290732|O4|Outcome|Intraductal Arm- 10 mg PLD|Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 10 mg, prior to conventional surgery for breast cancer.
1202761|NCT00290732|O3|Outcome|Intraductal Arm- 5 mg PLD|Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 5 mg, prior to conventional surgery for breast cancer.
1202762|NCT00290732|O2|Outcome|Intraductal Arm- 2 mg PLD|Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 2 mg, prior to conventional surgery for breast cancer.
1202987|NCT00289978|O3|Outcome|Placebo|Patients self-administered a fingolimod placebo capsule orally once daily.
1202764|NCT00290732|O5|Outcome|Intravenous Arm|Participants receiving standard intravenous administration of pegylated liposomal doxorubicin prior to breast biopsy for drug concentrations.
1202765|NCT00290732|O4|Outcome|Intraductal Arm- 10 mg PLD|Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 10 mg, prior to conventional surgery for breast cancer.
1202766|NCT00290732|O3|Outcome|Intraductal Arm- 5 mg PLD|Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 5 mg, prior to conventional surgery for breast cancer.
1202767|NCT00290732|O2|Outcome|Intraductal Arm- 2 mg PLD|Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 2 mg, prior to conventional surgery for breast cancer.
1202768|NCT00290732|O1|Outcome|Intraductal Arm- 0 mg PLD|Participants received intraductal administration of dextrose prior to conventional surgery for breast cancer.
1202769|NCT00290732|O1|Outcome|Intraductal Arm|Participants received intraductal administration of dextrose or dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD) prior to conventional surgery for breast cancer.
1202770|NCT00290732|E5|Reported Event|Intravenous Arm|Note: Adverse events were not collected in the intravenous group/arm; only the concentration of doxorubicin in tissue applied to this group of participants.
1202771|NCT00290732|E4|Reported Event|Intraductal Arm- 10 mg PLD|
1202772|NCT00290732|E3|Reported Event|Intraductal Arm- 5 mg PLD|
1202773|NCT00290732|E2|Reported Event|Intraductal Arm- 2 mg PLD|
1202774|NCT00290732|E1|Reported Event|Intraductal Arm- 0 mg PLD|
1202775|NCT00290693|B1|Baseline|CapTere (Capecitabine + Docetaxel)|"Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks~Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle"
1202776|NCT00290693|P1|Participant Flow|CapTere (Capecitabine + Docetaxel)|"Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks~Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle"
1202777|NCT00290693|O1|Outcome|CapTere (Capecitabine + Docetaxel)|"Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks~Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle"
1202778|NCT00290693|O1|Outcome|CapTere (Capecitabine + Docetaxel)|"Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks~Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle"
1202779|NCT00290693|E1|Reported Event|CapTere (Capecitabine + Docetaxel)|"Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks~Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle"
1202780|NCT00290654|B1|Baseline|MammoSite Treatment Group|Patients with ductal carcinoma in situ (DCIS, a non-invasive form of breast cancer) treated with standard lumpectomy/brachytherapy following by radiation using the MammoSite (FDA approved a balloon-catheter device placed in the lumpectomy cavity through which high dose radiation is delivered). Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient.
1203037|NCT00289900|P3|Participant Flow|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
1202781|NCT00290654|P1|Participant Flow|MammoSite Treatment Group|Patients with ductal carcinoma in situ (DCIS, a non-invasive form of breast cancer) treated with standard lumpectomy/brachytherapy following by radiation using the MammoSite (FDA approved a balloon-catheter device placed in the lumpectomy cavity through which high dose radiation is delivered). Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient.
1202782|NCT00290654|O1|Outcome|Evaluable Patients|Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
1202783|NCT00290654|O1|Outcome|Evaluable Patients|Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
1202784|NCT00290654|O1|Outcome|Evaluable Patients|Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
1202785|NCT00290654|O1|Outcome|Evaluable Patients|Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
1202786|NCT00290654|O1|Outcome|Evaluable Patients|Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
1202787|NCT00290654|O1|Outcome|Evaluable Patients|Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
1202788|NCT00290654|O1|Outcome|Evaluable Patients|Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
1202789|NCT00290654|O1|Outcome|Evaluable Patients|Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
1202790|NCT00290654|E1|Reported Event|MammoSite Treatment Group|Patients with ductal carcinoma in situ (DCIS, a non-invasive form of breast cancer) treated with standard lumpectomy/brachytherapy following by radiation using the MammoSite (FDA approved a balloon-catheter device placed in the lumpectomy cavity through which high dose radiation is delivered). Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient.
1202791|NCT00290615|B1|Baseline|Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab|"Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.~Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.~Cycles are 21 days."
1202792|NCT00290615|P1|Participant Flow|Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab|"Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.~Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.~Cycles are 21 days."
1202793|NCT00290615|O1|Outcome|Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab|"Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.~Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.~Cycles are 21 days."
1202988|NCT00289978|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily.
1202794|NCT00290615|O1|Outcome|Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab|"Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.~Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.~Cycles are 21 days."
1202795|NCT00290615|O1|Outcome|Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab|"Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.~Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.~Cycles are 21 days."
1202796|NCT00290615|O1|Outcome|Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab|"Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.~Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.~Cycles are 21 days."
1202797|NCT00290615|E1|Reported Event|Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab|"Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.~Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.~Cycles are 21 days."
1202798|NCT00290537|B1|Baseline|ZD6474|Part One: three 3-week cycles 300 mg of ZD6474 daily.
1202799|NCT00290537|P2|Participant Flow|Part Two: ZD6474 + Carboplatin + Paclitaxel|Second part of two part treatment, Part One /Two: participants randomized to receive 300 mg of ZD6474 daily, or 100 mg of ZD6474 daily plus carboplatin AUC 6.0 intravenous (IV) over 15-30 minutes and paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 every 3 weeks.
1202800|NCT00290537|P1|Participant Flow|Part One: ZD6474|First part of two part treatment, Part One: three 3-week cycles 300 mg of ZD6474 daily. Second part, Part Two: participants randomized to receive 300 mg of ZD6474 daily, or 100 mg of ZD6474 daily plus carboplatin AUC 6.0 intravenous (IV) over 15-30 minutes and paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 every 3 weeks
1202801|NCT00290537|O2|Outcome|ZD6474 + Carboplatin + Paclitaxel|Second part, patients randomized to receive 300 mg of ZD6474 daily, or 100 mg of ZD6474 daily plus carboplatin and paclitaxel every 3 weeks.
1202802|NCT00290537|O1|Outcome|ZD6474|First part of treatment: three 3-week cycles 300 mg of ZD6474 daily. Second part, patients randomized to receive 300 mg of ZD6474 daily, or 100 mg of ZD6474 daily plus carboplatin and paclitaxel every 3 weeks.
1202803|NCT00290537|E1|Reported Event|ZD6474|Part One: three 3-week cycles 300 mg of ZD6474 daily.
1202804|NCT00290472|B4|Baseline|Total|Total of all reporting groups
1203082|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
1202805|NCT00290472|B3|Baseline|Chronic Lymphocytic Leukemia|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
1202806|NCT00290472|B2|Baseline|Follicular Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.
1202807|NCT00290472|B1|Baseline|Aggressive B-cell Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.
1202808|NCT00290472|P3|Participant Flow|Chronic Lymphocytic Leukemia|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
1202809|NCT00290472|P2|Participant Flow|Follicular Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.
1202810|NCT00290472|P1|Participant Flow|Aggressive B-cell Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.
1202811|NCT00290472|O3|Outcome|Chronic Lymphocytic Leukemia|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
1202812|NCT00290472|O2|Outcome|Follicular Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.
1202813|NCT00290472|O1|Outcome|Aggressive B-cell Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.
1202842|NCT00290329|O2|Outcome|Mencevax ACWY 6-17 YOA Group|Filipino male or female subjects, between and including 6 to 17 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
1203759|NCT00288704|O2|Outcome|Rilonacept 160 mg|
1202814|NCT00290472|O3|Outcome|Chronic Lymphocytic Leukemia|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
1202815|NCT00290472|O2|Outcome|Follicular Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.
1202816|NCT00290472|O1|Outcome|Aggressive B-cell Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.
1202817|NCT00290472|O3|Outcome|Chronic Lymphocytic Leukemia|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
1202818|NCT00290472|O2|Outcome|Follicular Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.
1202819|NCT00290472|O1|Outcome|Aggressive B-cell Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.
1202820|NCT00290472|E1|Reported Event|Temsirolimus|All patients
1202821|NCT00290407|B1|Baseline|RITUXIMAB PLUS ORAL Β-GLUCAN|
1202822|NCT00290407|P1|Participant Flow|RITUXIMAB PLUS ORAL Β-GLUCAN|
1202823|NCT00290407|O1|Outcome|RITUXIMAB PLUS ORAL Β-GLUCAN|
1202824|NCT00290407|E1|Reported Event|RITUXIMAB PLUS ORAL Β-GLUCAN|
1202825|NCT00290329|B4|Baseline|Total|Total of all reporting groups
1202826|NCT00290329|B3|Baseline|Mencevax ACWY ≥ 18 YOA Group|Filipino male or female subjects, aged 18 or older, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
1202827|NCT00290329|B2|Baseline|Mencevax ACWY 6-17 YOA Group|Filipino male or female subjects, between and including 6 to 17 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
1202828|NCT00290329|B1|Baseline|Mencevax ACWY 2-5 YOA Group|Filipino male or female subjects, between and including 2 to 5 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
1202829|NCT00290329|P3|Participant Flow|Mencevax ACWY ≥ 18 YOA Group|Filipino male or female subjects, aged 18 or older, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
1202830|NCT00290329|P2|Participant Flow|Mencevax ACWY 6-17 YOA Group|Filipino male or female subjects, between and including 6 to 17 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
1202831|NCT00290329|P1|Participant Flow|Mencevax ACWY 2-5 YOA Group|Filipino male or female subjects, between and including 2 to 5 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
1202832|NCT00290329|O3|Outcome|Mencevax ACWY ≥ 18 YOA Group|Filipino male or female subjects, aged 18 or older, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
1202833|NCT00290329|O2|Outcome|Mencevax ACWY 6-17 YOA Group|Filipino male or female subjects, between and including 6 to 17 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
1202834|NCT00290329|O1|Outcome|Mencevax ACWY 2-5 YOA Group|Filipino male or female subjects, between and including 2 to 5 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
1202835|NCT00290329|O3|Outcome|Mencevax ACWY ≥ 18 YOA Group|Filipino male or female subjects, aged 18 or older, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
1202836|NCT00290329|O2|Outcome|Mencevax ACWY 6-17 YOA Group|Filipino male or female subjects, between and including 6 to 17 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
1202837|NCT00290329|O1|Outcome|Mencevax ACWY 2-5 YOA Group|Filipino male or female subjects, between and including 2 to 5 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
1202838|NCT00290329|O2|Outcome|Mencevax ACWY ≥ 18 YOA Group|Filipino male or female subjects, aged 18 or older, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
1202839|NCT00290329|O1|Outcome|Mencevax ACWY 6-17 YOA Group|Filipino male or female subjects, between and including 6 to 17 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
1202840|NCT00290329|O1|Outcome|Mencevax ACWY 2-5 YOA Group|Filipino male or female subjects, between and including 2 to 5 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
1202841|NCT00290329|O3|Outcome|Mencevax ACWY ≥ 18 YOA Group|Filipino male or female subjects, aged 18 or older, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
1202989|NCT00289978|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily.
1202843|NCT00290329|O1|Outcome|Mencevax ACWY 2-5 YOA Group|Filipino male or female subjects, between and including 2 to 5 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
1202844|NCT00290329|O3|Outcome|Mencevax ACWY ≥ 18 YOA Group|Filipino male or female subjects, aged 18 or older, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
1202845|NCT00290329|O2|Outcome|Mencevax ACWY 6-17 YOA Group|Filipino male or female subjects, between and including 6 to 17 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
1202846|NCT00290329|O1|Outcome|Mencevax ACWY 2-5 YOA Group|Filipino male or female subjects, between and including 2 to 5 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
1202847|NCT00290329|E3|Reported Event|Mencevax ACWY ≥ 18 YOA Group|Filipino male or female subjects, aged 18 or older, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
1202848|NCT00290329|E2|Reported Event|Mencevax ACWY 6-17 YOA Group|Filipino male or female subjects, between and including 6 to 17 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
1202849|NCT00290329|E1|Reported Event|Mencevax ACWY 2-5 YOA Group|Filipino male or female subjects, between and including 2 to 5 years of age, received a single dose of the Mencevax™ ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm.
1202850|NCT00290290|B3|Baseline|Total|Total of all reporting groups
1202851|NCT00290290|B2|Baseline|Chlorhexidine-alcohol|Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol
1202852|NCT00290290|B1|Baseline|Povidone-iodine|Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine
1202853|NCT00290290|P2|Participant Flow|Chlorhexidine-Alcohol|Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol
1202854|NCT00290290|P1|Participant Flow|Povidone-Iodine|Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine
1202855|NCT00290290|O2|Outcome|Chlorhexidine-Alcohol|Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol
1202856|NCT00290290|O1|Outcome|Povidone-Iodine|Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine
1202857|NCT00290290|E2|Reported Event|Chlorhexidine-Alcohol|Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol
1202858|NCT00290290|E1|Reported Event|Povidone-Iodine|Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine
1202859|NCT00290251|B1|Baseline|Eligible Women|All women who consented and were eligible
1202860|NCT00290251|P3|Participant Flow|Placebo (PLC)|Women received placebo capsules for 90 - 102 days or three menstrual cycles.
1202861|NCT00290251|P2|Participant Flow|Ulipristal Acetate- 10 mg|Women received ulipristal acetate at a daily dose of 10 mg for 90 - 102 days or three menstrual cycles.
1202862|NCT00290251|P1|Participant Flow|Ulipristal Acetate - 20 mg|Women received ulipristal acetate at a daily dose of 20 mg for 90 - 102 days or three menstrual cycles.
1202863|NCT00290251|O2|Outcome|Placebo|Women received placebo capsules for 90 - 102 days or three menstrual cycles.
1202864|NCT00290251|O1|Outcome|Ulipristal Acetate -10 and 20mg|Women received ulipristal acetate at a daily dose of 10 or 20 mg for 90 - 102 days or three menstrual cycles.
1202865|NCT00290251|O3|Outcome|Placebo|Women received placebo capsules for 90 - 102 days or three menstrual cycles.
1202866|NCT00290251|O2|Outcome|Ulipristal Acetate - 10 mg|Women received ulipristal acetate at 10 mg/day for 90 - 102 days or three menstrual cycles.
1202867|NCT00290251|O1|Outcome|Ulipristal Acetate -20mg|Women received ulipristal acetate at 20 mg/day for 90 - 102 days or three menstrual cycles.
1202868|NCT00290251|E3|Reported Event|Placebo|Women received placebo capsules for 90 - 102 days or three menstrual cycles.
1202869|NCT00290251|E2|Reported Event|CDB-2914 - 10 mg|Women received CDB-2914 at a daily dose of 10 mg for 90 - 102 days or three menstrual cycles.
1202870|NCT00290251|E1|Reported Event|CDB-2914 -20mg|Women received CDB-2914 at a daily dose of 20 mg for 90 - 102 days or three menstrual cycles.
1202871|NCT00290238|B3|Baseline|Total|Total of all reporting groups
1202872|NCT00290238|B2|Baseline|Transcutaneous Electrical Nerve Stimulation (TENS)|Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds.
1202873|NCT00290238|B1|Baseline|Percutaneous Neuromodulation Therapy (PNT)|Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform.
1202874|NCT00290238|P2|Participant Flow|Transcutaneous Electrical Nerve Stimulation (TENS)|Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds.
1202875|NCT00290238|P1|Participant Flow|Percutaneous Neuromodulation Therapy (PNT)|Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform.
1202876|NCT00290238|O2|Outcome|Transcutaneous Electrical Nerve Stimulation (TENS)|Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds.
1202877|NCT00290238|O1|Outcome|Percutaneous Neuromodulation Therapy (PNT)|Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform.
1202878|NCT00290238|O2|Outcome|Transcutaneous Electrical Nerve Stimulation (TENS)|Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds.
1202917|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202879|NCT00290238|O1|Outcome|Percutaneous Neuromodulation Therapy (PNT)|Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform.
1202880|NCT00290238|E2|Reported Event|Transcutaneous Electrical Nerve Stimulation (TENS)|Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds.
1202881|NCT00290238|E1|Reported Event|Percutaneous Neuromodulation Therapy (PNT)|Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform.
1202882|NCT00290199|B3|Baseline|Total|Total of all reporting groups
1202883|NCT00290199|B2|Baseline|No Foley|No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
1202884|NCT00290199|B1|Baseline|Transcervical Foley|Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
1202885|NCT00290199|P2|Participant Flow|No Foley|No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
1202886|NCT00290199|P1|Participant Flow|Transcervical Foley|Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
1202887|NCT00290199|O2|Outcome|No Foley|No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
1202888|NCT00290199|O1|Outcome|Transcervical Foley|Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
1202889|NCT00290199|O2|Outcome|No Foley|No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
1202890|NCT00290199|O1|Outcome|Transcervical Foley|Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
1202891|NCT00290199|O2|Outcome|No Foley|No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
1202892|NCT00290199|O1|Outcome|Transcervical Foley|Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
1202893|NCT00290199|O2|Outcome|No Foley|No transcervical foley catheter inserted to induce labor
1202894|NCT00290199|O1|Outcome|Transcervical Foley|Insertion of a a transcervical foley catheter to induce labor
1202895|NCT00290199|E2|Reported Event|No Foley|No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
1202896|NCT00290199|E1|Reported Event|Transcervical Foley|Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
1202897|NCT00290186|B3|Baseline|Total|Total of all reporting groups
1203083|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
1202898|NCT00290186|B2|Baseline|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202899|NCT00290186|B1|Baseline|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202900|NCT00290186|P2|Participant Flow|Hyperbaric Air Treatment (HBA)|"Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total~24 Were allocated to HBA 22 Completed all 40 treatments~1 Withdrew prior to treatments~1 Withdrawn during treatments for seizures due to shunt malfunction 22 Completed post treatment testing~1 Study terminated prior to 3-month followup testing 21 Completed 3-month followup testing~1 Did not return for 6-month followup testing~1 Missed 6-month followup testing due to illness not related to study 19 Completed 6-month followup testing 22 Included in pre and post treatment analyses 21 Included in pre, post, and 3-month analyses 19 Included in pre, post, 3-month and 6-month analyses"
1202901|NCT00290186|P1|Participant Flow|Hyperbaric Oxygen Treatment (HBO)|"Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total~25 Were allocated to HBO 24 Completed all 40 treatments~1 Withdrawn during treatments due to right ear problems and rectal bleeding 24 Completed post treatment testing~Study terminated prior to 3-month followup testing~Did not return for 3- or 6-month followup testing~1 Missed 3-month followup due to illness not related to study but returned for 6-month followup testing 20 Completed 3-month followup testing 20 Completed 6-month testing 24 Included in pre and post treatment analyses 20 Included in pre, post, and 3-month analyses 20 Included in pre, post, 3-month and 6-month analyses"
1202902|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202903|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202904|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202905|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202906|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202907|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202908|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202909|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202910|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202911|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202912|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202913|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202914|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202915|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202916|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202919|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202920|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202921|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202922|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202923|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202924|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202925|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202926|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202927|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202928|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202929|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202930|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202931|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202932|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|"14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total~Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total"
1202933|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|"100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total~Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total"
1202934|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202935|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202936|NCT00290186|E2|Reported Event|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202937|NCT00290186|E1|Reported Event|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
1202938|NCT00290147|B3|Baseline|Total|Total of all reporting groups
1202939|NCT00290147|B2|Baseline|5.0 mg of D1ME100 Vaccine|"5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months~D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
1202940|NCT00290147|B1|Baseline|1.0 mg of D1ME100 Vaccine|"1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months~D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
1202941|NCT00290147|P2|Participant Flow|5.0 mg of D1ME100 Vaccine|"5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months~D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
1202942|NCT00290147|P1|Participant Flow|1.0 mg of D1ME100 Vaccine|"1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months~D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
1202943|NCT00290147|O2|Outcome|5.0 mg of D1ME100 Vaccine|"5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months~D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
1202944|NCT00290147|O1|Outcome|1.0 mg of D1ME100 Vaccine|"1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months~D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
1202945|NCT00290147|O2|Outcome|5.0 mg of D1ME100 Vaccine|"5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months~D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
1202946|NCT00290147|O1|Outcome|1.0 mg of D1ME100 Vaccine|"1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months~D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
1202947|NCT00290147|E2|Reported Event|5.0 mg of D1ME100 Vaccine|"5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months~D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
1202948|NCT00290147|E1|Reported Event|1.0 mg of D1ME100 Vaccine|"1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months~D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector"
1202949|NCT00289991|B3|Baseline|Total|Total of all reporting groups
1202950|NCT00289991|B2|Baseline|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
1202951|NCT00289991|B1|Baseline|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
1202952|NCT00289991|P2|Participant Flow|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
1202953|NCT00289991|P1|Participant Flow|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen intravenous (IV) for first 24 hours: 6 milligrams per kilogram (mg/kg) of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) twice daily (BID) or 200 mg tablet or powder for oral suspension by mouth (PO) BID (subjects greater than or equal to [≥] 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects less than [<] 40 kg body weight).
1202954|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
1202955|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
1202956|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
1202957|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
1202958|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
1202959|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
1202960|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
1202961|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
1202962|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
1202963|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
1202964|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
1203004|NCT00289913|O5|Outcome|VAQTA™/ VAQTA™ (Stage 2)|"Day 1: The first dose of VAQTA™ was administered.~Week 24: The second dose of VAQTA™ was administered."
1202965|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
1202966|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
1202967|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
1202968|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
1202969|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
1202970|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
1202971|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
1202972|NCT00289991|E2|Reported Event|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
1202973|NCT00289991|E1|Reported Event|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
1202974|NCT00289978|B4|Baseline|Total|Total of all reporting groups
1202975|NCT00289978|B3|Baseline|Placebo|Patients self-administered a fingolimod placebo capsule orally once daily.
1202976|NCT00289978|B2|Baseline|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily.
1202977|NCT00289978|B1|Baseline|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily.
1202978|NCT00289978|P3|Participant Flow|Placebo|Patients self-administered a fingolimod placebo capsule orally once daily.
1202979|NCT00289978|P2|Participant Flow|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily.
1202980|NCT00289978|P1|Participant Flow|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily.
1202981|NCT00289978|O3|Outcome|Placebo|Patients self-administered a fingolimod placebo capsule orally once daily.
1202982|NCT00289978|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily.
1202983|NCT00289978|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily.
1202984|NCT00289978|O3|Outcome|Placebo|Patients self-administered a fingolimod placebo capsule orally once daily.
1202985|NCT00289978|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily.
1202986|NCT00289978|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily.
1202991|NCT00289978|E2|Reported Event|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily.
1202992|NCT00289978|E1|Reported Event|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily.
1202993|NCT00289913|B6|Baseline|Total|Total of all reporting groups
1202994|NCT00289913|B5|Baseline|VAQTA™/ VAQTA™ (Stage 2)|"Day 1: The first dose of VAQTA™ was administered.~Week 24: The second dose of VAQTA™ was administered."
1202995|NCT00289913|B4|Baseline|PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ was administered.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
1202996|NCT00289913|B3|Baseline|VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
1202997|NCT00289913|B2|Baseline|PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
1202998|NCT00289913|B1|Baseline|VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
1202999|NCT00289913|P5|Participant Flow|VAQTA™/ VAQTA™ (Stage 2)|"Day 1: The first dose of VAQTA™ was administered.~Week 24: The second dose of VAQTA™ was administered."
1203000|NCT00289913|P4|Participant Flow|PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ was administered.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
1203001|NCT00289913|P3|Participant Flow|VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
1203002|NCT00289913|P2|Participant Flow|PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
1203003|NCT00289913|P1|Participant Flow|VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
1203005|NCT00289913|O4|Outcome|PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ was administered.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
1203006|NCT00289913|O3|Outcome|VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
1203007|NCT00289913|O2|Outcome|PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
1203008|NCT00289913|O1|Outcome|VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
1203009|NCT00289913|O3|Outcome|VAQTA™/VAQTA™|All participants receiving VAQTA™ alone (from Stage II) on Day 1 and Day 24.
1203010|NCT00289913|O2|Outcome|Non-concomitant VAQTA™ Separate From Infanrix™ and PedvaxHIB™|All participants receiving VAQTA™ non-concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ were pooled for safety analysis; and includes participants from Groups 2: PedvaxHIB™ and Infanrix™/VAQTA™/VAQTA™ (Stage 1); and Group 4: PedvaxHIB™/VAQTA™/VAQTA™ (Stage 1).
1203011|NCT00289913|O1|Outcome|Concomitant VAQTA™ With Infanrix™ and PedvaxHIB™ or PedvaxHIB™|All participants receiving VAQTA™ Concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ were pooled for safety analysis; and includes participants from Groups 1: VAQTA™, PedvaxHIB™ and Infanrix™/VAQTA™ (Stage 1); and Group 3: VAQTA™, PedvaxHIB™/VAQTA™ (Stage 1).
1203012|NCT00289913|O5|Outcome|VAQTA™/ VAQTA™ (Stage 2)|"Day 1: The first dose of VAQTA™ was administered.~Week 24: The second dose of VAQTA™ was administered."
1203013|NCT00289913|O4|Outcome|PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ was administered.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
1203014|NCT00289913|O3|Outcome|VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
1203015|NCT00289913|O2|Outcome|PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
1203016|NCT00289913|O1|Outcome|VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
1203017|NCT00289913|O5|Outcome|VAQTA™/ VAQTA™ (Stage 2)|"Day 1: The first dose of VAQTA™ was administered.~Week 24: The second dose of VAQTA™ was administered."
1203018|NCT00289913|O4|Outcome|PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ was administered.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
1203019|NCT00289913|O3|Outcome|VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
1203020|NCT00289913|O2|Outcome|PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
1203062|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
1203760|NCT00288704|O1|Outcome|Placebo|
1203021|NCT00289913|O1|Outcome|VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
1203022|NCT00289913|E5|Reported Event|VAQTA™/ VAQTA™ (Stage 2)|"Day 1: The first dose of VAQTA™ was administered.~Week 24: The second dose of VAQTA™ was administered."
1203023|NCT00289913|E4|Reported Event|PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage I)|"Day 1: PedvaxHIB™ was administered.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
1203024|NCT00289913|E3|Reported Event|VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
1203025|NCT00289913|E2|Reported Event|PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
1203026|NCT00289913|E1|Reported Event|VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
1203027|NCT00289900|B7|Baseline|Total|Total of all reporting groups
1203028|NCT00289900|B6|Baseline|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
1203029|NCT00289900|B5|Baseline|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
1203030|NCT00289900|B4|Baseline|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
1203031|NCT00289900|B3|Baseline|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
1203032|NCT00289900|B2|Baseline|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
1203033|NCT00289900|B1|Baseline|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
1203034|NCT00289900|P6|Participant Flow|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
1203035|NCT00289900|P5|Participant Flow|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
1203036|NCT00289900|P4|Participant Flow|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
1203038|NCT00289900|P2|Participant Flow|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
1203039|NCT00289900|P1|Participant Flow|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
1203040|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
1203041|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
1203042|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
1203043|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
1203044|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
1203045|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
1203046|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
1203047|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
1203048|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
1203049|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
1203050|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
1203051|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
1203052|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
1203053|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
1203054|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
1203055|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
1203056|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
1203057|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
1203058|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
1203059|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
1203060|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
1203061|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
1203761|NCT00288704|E2|Reported Event|Placebo|
1203063|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
1203064|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
1203065|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg and MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
1203066|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
1203067|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg and MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
1203068|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
1203069|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
1203070|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
1203071|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
1203072|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
1203073|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
1203074|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
1203075|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
1203076|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
1203077|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
1203078|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
1203079|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
1203080|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
1203081|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
1203084|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
1203085|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
1203086|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
1203087|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
1203088|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
1203089|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
1203090|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
1203091|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
1203092|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
1203093|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
1203094|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
1203095|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
1203096|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
1203097|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
1203098|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
1203099|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
1203100|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
1203101|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
1203102|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
1203103|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
1203104|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
1203105|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
1203106|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
1203107|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
1203762|NCT00288704|E1|Reported Event|Rilonacept 160 mg|
1203108|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
1203109|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
1203110|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
1203111|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
1203112|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
1203113|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
1203114|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
1203115|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
1203116|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
1203117|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
1203118|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
1203119|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
1203120|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
1203121|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
1203122|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
1203123|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
1203124|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
1203125|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
1203126|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
1203983|NCT00286754|B3|Baseline|Usual Care (UC)|treatment as usual for hypertension
1203127|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
1203128|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
1203129|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
1203130|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
1203131|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
1203132|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
1203133|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
1203134|NCT00289900|E6|Reported Event|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
1203135|NCT00289900|E5|Reported Event|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
1203136|NCT00289900|E4|Reported Event|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
1203137|NCT00289900|E3|Reported Event|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
1203138|NCT00289900|E2|Reported Event|MK-0524B 2g/40 mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
1203139|NCT00289900|E1|Reported Event|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
1203140|NCT00289887|B3|Baseline|Total|Total of all reporting groups
1203141|NCT00289887|B2|Baseline|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
1203142|NCT00289887|B1|Baseline|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
1203143|NCT00289887|P2|Participant Flow|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
1203144|NCT00289887|P1|Participant Flow|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
1203145|NCT00289887|O2|Outcome|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
1203146|NCT00289887|O1|Outcome|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
1203147|NCT00289887|O2|Outcome|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
1203148|NCT00289887|O1|Outcome|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
1203149|NCT00289887|O2|Outcome|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
1203150|NCT00289887|O1|Outcome|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
1203151|NCT00289887|O2|Outcome|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
1203152|NCT00289887|O1|Outcome|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
1203153|NCT00289887|O2|Outcome|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
1203154|NCT00289887|O1|Outcome|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
1203155|NCT00289887|O2|Outcome|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
1203156|NCT00289887|O1|Outcome|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
1203157|NCT00289887|E2|Reported Event|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
1203158|NCT00289887|E1|Reported Event|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
1203159|NCT00289874|B3|Baseline|Total|Total of all reporting groups
1203160|NCT00289874|B2|Baseline|Placebo|Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
1203161|NCT00289874|B1|Baseline|Montelukast 5 mg|Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
1203162|NCT00289874|P2|Participant Flow|Placebo|Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
1203163|NCT00289874|P1|Participant Flow|Montelukast 5 mg|Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
1203164|NCT00289874|O2|Outcome|Placebo|Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
1203165|NCT00289874|O1|Outcome|Montelukast 5 mg|Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
1203166|NCT00289874|O2|Outcome|Placebo|Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
1203167|NCT00289874|O1|Outcome|Montelukast 5 mg|Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
1203168|NCT00289874|E2|Reported Event|Placebo|Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
1203169|NCT00289874|E1|Reported Event|Montelukast 5 mg|Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
1203170|NCT00289848|B3|Baseline|Total|Total of all reporting groups
1203171|NCT00289848|B2|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
1203172|NCT00289848|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
1203173|NCT00289848|P2|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
1203174|NCT00289848|P1|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
1203175|NCT00289848|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
1203176|NCT00289848|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
1203177|NCT00289848|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
1203178|NCT00289848|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
1203179|NCT00289848|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
1203180|NCT00289848|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
1203181|NCT00289848|E2|Reported Event|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
1203182|NCT00289848|E1|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
1203183|NCT00289783|B3|Baseline|Total|Total of all reporting groups
1203184|NCT00289783|B2|Baseline|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203373|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
1203830|NCT00288574|B2|Baseline|Placebo|Placebo group
1203185|NCT00289783|B1|Baseline|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203186|NCT00289783|P2|Participant Flow|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203187|NCT00289783|P1|Participant Flow|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203188|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203189|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203385|NCT00289757|O1|Outcome|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
1204237|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1203190|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203191|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203192|NCT00289783|O2|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203193|NCT00289783|O1|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203194|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203195|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203196|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203197|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203374|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
1203198|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203199|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203200|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203201|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203202|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1204709|NCT00286429|B4|Baseline|Total|Total of all reporting groups
1203203|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203204|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203205|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203206|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203207|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203208|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203209|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203210|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203375|NCT00289770|E1|Reported Event|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
1204969|NCT00285584|B3|Baseline|Total|Total of all reporting groups
1203211|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203212|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203213|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203214|NCT00289783|O2|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203215|NCT00289783|O1|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203216|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203217|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203218|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203219|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203220|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203221|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203222|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203223|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203402|NCT00289744|O1|Outcome|Twinrix Group|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
1205518|NCT00283595|B2|Baseline|Placebo Group|Treatment with Placebo
1203224|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203225|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203226|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203227|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203228|NCT00289783|O2|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203229|NCT00289783|O1|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203230|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203231|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203232|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203233|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203234|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203235|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203236|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203403|NCT00289744|O1|Outcome|Twinrix Group|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
1203831|NCT00288574|B1|Baseline|Fluoxetine|"fluoxetine up to 80 mg per day~Fluoxetine"
1203237|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203238|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203239|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203240|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203241|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203242|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203243|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203244|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203245|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203246|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203247|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203248|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203249|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203455|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
1203456|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
1203457|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
1203250|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203251|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203252|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203253|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203254|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203255|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203256|NCT00289783|O5|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203257|NCT00289783|O4|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203258|NCT00289783|O3|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203259|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203260|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203261|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203262|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203458|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
1203459|NCT00289536|E1|Reported Event|Safety Population (26 Participants)|Participants who received at least 1 infusion of rAHF-PFM
1203263|NCT00289783|O5|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203264|NCT00289783|O4|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203265|NCT00289783|O3|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203266|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203267|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203268|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203269|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203270|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203271|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203272|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203273|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203274|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203275|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203460|NCT00289471|B1|Baseline|Cognitive Screening|"Cognitive screening~No intervention delivered.: No intervention delivered."
1203832|NCT00288574|P2|Participant Flow|Placebo|Placebo group
1203276|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203277|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203278|NCT00289783|O5|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203279|NCT00289783|O4|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203280|NCT00289783|O3|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203281|NCT00289783|O2|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203282|NCT00289783|O1|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203283|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203284|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203285|NCT00289783|O5|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203286|NCT00289783|O4|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203287|NCT00289783|O3|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203288|NCT00289783|O2|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203461|NCT00289471|P1|Participant Flow|Cognitive Screening|"Cognitive screening~No intervention delivered.: No intervention delivered."
1203289|NCT00289783|O1|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203290|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203291|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203292|NCT00289783|O5|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203293|NCT00289783|O4|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203294|NCT00289783|O3|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203295|NCT00289783|O2|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203296|NCT00289783|O1|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203297|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203298|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203299|NCT00289783|O5|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203300|NCT00289783|O4|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203301|NCT00289783|O3|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203462|NCT00289471|O1|Outcome|Cognitive Screening|"Cognitive screening~No intervention delivered.: No intervention delivered."
1203302|NCT00289783|O2|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203303|NCT00289783|O1|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203304|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203305|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203306|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203307|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203308|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203309|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203310|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203311|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203312|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203313|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203314|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203463|NCT00289471|E1|Reported Event|Cognitive Screening|"Cognitive screening~No intervention delivered.: No intervention delivered."
1203464|NCT00289458|B4|Baseline|Total|Total of all reporting groups
1203315|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203316|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203317|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203318|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203319|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203320|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203321|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203322|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203323|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203324|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203325|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203326|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203327|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203507|NCT00289289|B2|Baseline|Off-On|Subjects have intervention pacing features turned Off according to the randomization assignment for the first crossover period and then On in the second period.
1203328|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203329|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203330|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203331|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203332|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203333|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203334|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203335|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203336|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203337|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203338|NCT00289783|O5|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203339|NCT00289783|O4|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203340|NCT00289783|O3|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203508|NCT00289289|B1|Baseline|On-Off|Subjects have intervention pacing features turned On according to randomization assignment in the first crossover period then Off in the second period.
1203341|NCT00289783|O2|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203342|NCT00289783|O1|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203343|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203344|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203345|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203346|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203347|NCT00289783|O5|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203348|NCT00289783|O4|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203349|NCT00289783|O3|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203350|NCT00289783|O2|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203351|NCT00289783|O1|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203352|NCT00289783|O5|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203353|NCT00289783|O4|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203509|NCT00289289|P3|Participant Flow|Non-Randomized Group|Subjects exiting prior to the 3-month randomization visit or subjects with no AT/AF burden during the 3-month observation period
1203354|NCT00289783|O3|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203355|NCT00289783|O2|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203356|NCT00289783|O1|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203357|NCT00289783|O5|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203358|NCT00289783|O4|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203359|NCT00289783|O3|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203360|NCT00289783|O2|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203361|NCT00289783|O1|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203362|NCT00289783|E2|Reported Event|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203363|NCT00289783|E1|Reported Event|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
1203364|NCT00289770|B1|Baseline|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
1203365|NCT00289770|P1|Participant Flow|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
1203366|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
1203367|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
1203368|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
1203369|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
1203370|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
1203371|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
1203372|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
1203833|NCT00288574|P1|Participant Flow|Fluoxetine|"fluoxetine up to 80 mg per day~Fluoxetine"
1203376|NCT00289757|B1|Baseline|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
1203377|NCT00289757|P1|Participant Flow|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
1203378|NCT00289757|O1|Outcome|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
1203379|NCT00289757|O1|Outcome|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
1203380|NCT00289757|O1|Outcome|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
1203381|NCT00289757|O1|Outcome|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
1203382|NCT00289757|O1|Outcome|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
1203383|NCT00289757|O1|Outcome|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
1203384|NCT00289757|O1|Outcome|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
1203386|NCT00289757|E1|Reported Event|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
1203387|NCT00289744|B1|Baseline|Twinrix Group|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
1203388|NCT00289744|P3|Participant Flow|Engerix-B Additional Dose (Pediatric)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
1203389|NCT00289744|P2|Participant Flow|Engerix-B Additional Dose (Adult)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose).
1203390|NCT00289744|P1|Participant Flow|Twinrix Group|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
1203391|NCT00289744|O2|Outcome|Engerix-B Additional Dose (Pediatric)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
1203392|NCT00289744|O1|Outcome|Engerix-B Additional Dose (Adult)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose).
1203393|NCT00289744|O2|Outcome|Engerix-B Additional Dose (Pediatric)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
1203394|NCT00289744|O1|Outcome|Engerix-B Additional Dose (Adult)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose).
1203395|NCT00289744|O2|Outcome|Engerix-B Additional Dose (Pediatric)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
1203396|NCT00289744|O1|Outcome|Engerix-B Additional Dose (Adult)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose).
1203397|NCT00289744|O1|Outcome|Twinrix Group|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
1203398|NCT00289744|O2|Outcome|Engerix-B Additional Dose (Pediatric)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
1203399|NCT00289744|O1|Outcome|Engerix-B Additional Dose (Adult)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose).
1203400|NCT00289744|O2|Outcome|Engerix-B Additional Dose (Pediatric)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
1203401|NCT00289744|O1|Outcome|Engerix-B Additional Dose (Adult)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose).
1203834|NCT00288574|O2|Outcome|Placebo|Placebo group
1203404|NCT00289744|E3|Reported Event|Engerix-B Additional Dose (Pediatric)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
1203405|NCT00289744|E2|Reported Event|Twinrix Group|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
1203406|NCT00289744|E1|Reported Event|Engerix-B Additional Dose (Adult)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose).
1203407|NCT00289718|B1|Baseline|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
1203408|NCT00289718|P1|Participant Flow|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
1203409|NCT00289718|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
1203410|NCT00289718|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
1203411|NCT00289718|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
1203412|NCT00289718|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
1203413|NCT00289718|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
1203479|NCT00289458|O1|Outcome|Control Group|Continued with usual activity and care, no intervention
1203414|NCT00289718|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
1203415|NCT00289718|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
1203416|NCT00289718|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
1203417|NCT00289718|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
1203418|NCT00289718|E1|Reported Event|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
1203419|NCT00289536|B1|Baseline|Treated Participants|Participants who received at least 1 infusion of rAHF-PFM.
1203420|NCT00289536|P3|Participant Flow|High Dose|50 IU/kg rAHF-PFM
1203421|NCT00289536|P2|Participant Flow|Medium Dose|30 IU/kg rAHF-PFM
1203422|NCT00289536|P1|Participant Flow|Low Dose|15 IU/kg rAHF-PFM
1203423|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
1203424|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
1203425|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
1203426|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
1203427|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
1203428|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
1203429|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
1203430|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
1203431|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
1203432|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
1203433|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
1203434|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
1203435|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
1203436|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
1203437|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
1203438|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
1203439|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
1203440|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
1203441|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
1203442|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
1203443|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
1203444|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
1203445|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
1203446|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
1203447|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
1203448|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
1203449|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
1203450|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
1203451|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
1203452|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
1203453|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
1203454|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
1203465|NCT00289458|B3|Baseline|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
1203466|NCT00289458|B2|Baseline|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
1203467|NCT00289458|B1|Baseline|Control Group|Continued with usual activity and care, no intervention
1203468|NCT00289458|P3|Participant Flow|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
1203469|NCT00289458|P2|Participant Flow|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
1203470|NCT00289458|P1|Participant Flow|Control Group|Continued with usual activity and care, no intervention
1203471|NCT00289458|O3|Outcome|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
1203472|NCT00289458|O2|Outcome|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
1203473|NCT00289458|O1|Outcome|Control Group|Continued with usual activity and care, no intervention
1203474|NCT00289458|O3|Outcome|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
1203475|NCT00289458|O2|Outcome|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
1203476|NCT00289458|O1|Outcome|Control Group|Continued with usual activity and care, no intervention
1203477|NCT00289458|O3|Outcome|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
1203478|NCT00289458|O2|Outcome|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
1203697|NCT00288886|B3|Baseline|Total|Total of all reporting groups
1203480|NCT00289458|O3|Outcome|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
1203481|NCT00289458|O2|Outcome|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
1203482|NCT00289458|O1|Outcome|Control Group|Continued with usual activity and care, no intervention
1203483|NCT00289458|O3|Outcome|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
1203484|NCT00289458|O2|Outcome|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
1203485|NCT00289458|O1|Outcome|Control Group|Continued with usual activity and care, no intervention
1203486|NCT00289458|O3|Outcome|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
1203487|NCT00289458|O2|Outcome|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
1203488|NCT00289458|O1|Outcome|Control Group|Continued with usual activity and care, no intervention
1203489|NCT00289458|E3|Reported Event|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
1203490|NCT00289458|E2|Reported Event|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
1203491|NCT00289458|E1|Reported Event|Control Group|Continued with usual activity and care, no intervention
1203492|NCT00289341|B3|Baseline|Total|Total of all reporting groups
1203493|NCT00289341|B2|Baseline|Placebo|
1203494|NCT00289341|B1|Baseline|Dendritic Cells Pulsed With LNCaP (DC/LNCaP)|12 patients, receiving DC/LNCaP vaccine and the DC/LNCaP-M1 and DC/KLH immunizations over 8 weeks. THE PURPOSE OF THESE 2 ARMS IS TO COMPARE ADVERSE EVENTS (AEs) DURING THE 1ST 8 WKS ONLY.
1203495|NCT00289341|P2|Participant Flow|Placebo|
1203496|NCT00289341|P1|Participant Flow|Dendritic Cells Pulsed With LNCaP (DC/LNCaP)|12 patients, receiving DC/LNCaP vaccine and the DC/LNCaP-M1 and DC/KLH immunizations over 8 weeks. THE PURPOSE OF THESE 2 ARMS IS TO COMPARE ADVERSE EVENTS (AEs) DURING THE 1ST 8 WKS ONLY.
1203497|NCT00289341|O1|Outcome|Pre-vs Post-vaccination PSA Slope|
1203498|NCT00289341|O1|Outcome|Median Difference, Post-Pre Vaccination|For each antigen group, the difference between the post and pre-vaccination T cell proliferation response was calculated.
1203499|NCT00289341|O2|Outcome|Placebo|12 patients receiving vehicle only
1203500|NCT00289341|O1|Outcome|Dendritic Cells Pulsed With LNCaP (DC/LNCaP)|12 patients, receiving DC/LNCaP vaccine and the DC/LNCaP-M1 and DC/KLH immunizations over 8 weeks. THE PURPOSE OF THESE 2 ARMS IS TO COMPARE ADVERSE EVENTS (AEs) DURING THE 1ST 8 WKS ONLY.
1203501|NCT00289341|E4|Reported Event|Arm 1 and 2 Post-Vaccination Phase|unblinded
1203502|NCT00289341|E3|Reported Event|Arm 2 Vaccine Phase|Unblinded
1203503|NCT00289341|E2|Reported Event|Arm 1 Vaccine Phase|Single blind
1203504|NCT00289341|E1|Reported Event|Arm 2 Placebo Phase|Single-blind
1203505|NCT00289289|B4|Baseline|Total|Total of all reporting groups
1203506|NCT00289289|B3|Baseline|Non-Randomized Group|Subjects exiting prior to the 3-month randomization visit or subjects with no AT/AF burden during the 3-month observation period
1203510|NCT00289289|P2|Participant Flow|Off-On|Subjects have intervention pacing features turned Off according to the randomization assignment for the first crossover period and then On in the second period.
1203511|NCT00289289|P1|Participant Flow|On-Off|Subjects have intervention pacing features turned On according to randomization assignment in the first crossover period then Off in the second period.
1203512|NCT00289289|O2|Outcome|Intervention Pacing Features Programmed OFF|6-month period subjects had the intervention pacing features programmed OFF. For subjects randomized to the ON-OFF group, this was the 9-15 month post-implant period. For subjects randomized to the OFF-ON group this was the 3-9 month post-implant period.
1203513|NCT00289289|O1|Outcome|Intervention Pacing Features Programmed ON|6-month period subjects had the intervention pacing features programmed ON. For subjects randomized to the ON-OFF group, this was the 3-9 month post-implant period. For subjects randomized to the OFF-ON group this was the 9-15 month post-implant period.
1203514|NCT00289289|O2|Outcome|Intervention Pacing Features Programmed OFF|6-month period subjects had the intervention pacing features programmed OFF. For subjects randomized to the ON-OFF group, this was the 9-15 month post-implant period. For subjects randomized to the OFF-ON group this was the 3-9 month post-implant period.
1203515|NCT00289289|O1|Outcome|Intervention Pacing Features Programmed ON|6-month period subjects had the intervention pacing features programmed ON. For subjects randomized to the ON-OFF group, this was the 3-9 month post-implant period. For subjects randomized to the OFF-ON group this was the 9-15 month post-implant period.
1203516|NCT00289289|O2|Outcome|Intervention Pacing Features Programmed OFF|6-month period subjects had the intervention pacing features programmed OFF. For subjects randomized to the ON-OFF group, this was the 9-15 month post-implant period. For subjects randomized to the OFF-ON group this was the 3-9 month post-implant period.
1203517|NCT00289289|O1|Outcome|Intervention Pacing Features Programmed ON|6-month period subjects had the intervention pacing features programmed ON. For subjects randomized to the ON-OFF group, this was the 3-9 month post-implant period. For subjects randomized to the OFF-ON group this was the 9-15 month post-implant period.
1203518|NCT00289289|O2|Outcome|Intervention Pacing Features Programmed OFF|6-month period subjects had the intervention pacing features programmed OFF. For subjects randomized to the ON-OFF group, this was the 9-15 month post-implant period. For subjects randomized to the OFF-ON group this was the 3-9 month post-implant period.
1203878|NCT00287872|B1|Baseline|Bortezomib and Thalidomide|"The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.~bortezomib~thalidomide"
1203519|NCT00289289|O1|Outcome|Intervention Pacing Features Programmed ON|6-month period subjects had the intervention pacing features programmed ON. For subjects randomized to the ON-OFF group, this was the 3-9 month post-implant period. For subjects randomized to the OFF-ON group this was the 9-15 month post-implant period.
1203520|NCT00289289|E3|Reported Event|Non-Randomized Group|Subjects exiting prior to the 3-month randomization visit or subjects with no AT/AF burden during the 3-month observation period
1203521|NCT00289289|E2|Reported Event|Off-On|Subjects have intervention pacing features turned Off according to the randomization assignment for the first crossover period and then On in the second period.
1203522|NCT00289289|E1|Reported Event|On-Off|Subjects have intervention pacing features turned On according to randomization assignment in the first crossover period then Off in the second period.
1203523|NCT00289276|B3|Baseline|Total|Total of all reporting groups
1203524|NCT00289276|B2|Baseline|FAST Expansion|FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.
1203525|NCT00289276|B1|Baseline|FAST Pivotal|FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
1203526|NCT00289276|P2|Participant Flow|FAST Expansion|FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.
1203527|NCT00289276|P1|Participant Flow|FAST Pivotal|FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
1203528|NCT00289276|O2|Outcome|FAST Expansion|FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.
1203529|NCT00289276|O1|Outcome|FAST Pivotal|FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
1203530|NCT00289276|O2|Outcome|FAST Expansion|FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.
1203531|NCT00289276|O1|Outcome|FAST Pivotal|FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
1203532|NCT00289276|O2|Outcome|FAST Expansion|FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.
1203835|NCT00288574|O1|Outcome|Fluoxetine|"fluoxetine up to 80 mg per day~Fluoxetine"
1203836|NCT00288574|E2|Reported Event|Placebo|Placebo Medication
1203533|NCT00289276|O1|Outcome|FAST Pivotal|FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
1203534|NCT00289276|O2|Outcome|FAST Expansion|FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.
1203535|NCT00289276|O1|Outcome|FAST Pivotal|FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
1203536|NCT00289276|E2|Reported Event|FAST Expansion|FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.
1203537|NCT00289276|E1|Reported Event|FAST Pivotal|FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
1203538|NCT00289211|B4|Baseline|Total|Total of all reporting groups
1203539|NCT00289211|B3|Baseline|Open-label C1INH-nf Only|Twelve subjects were never randomized but received open-label C1INH-nf for treatment of laryngeal angioedema and/or prior to emergency surgical procedures. These subjects were analyzed for safety only.
1203540|NCT00289211|B2|Baseline|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
1203541|NCT00289211|B1|Baseline|C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
1203542|NCT00289211|P3|Participant Flow|Open-label C1INH-nf Only|Twelve subjects were never randomized but received open-label C1INH-nf for treatment of laryngeal angioedema and/or prior to emergency surgical procedures. These subjects were analyzed for safety only.
1203543|NCT00289211|P2|Participant Flow|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
1203544|NCT00289211|P1|Participant Flow|C1INH-nf|1,000 Units (U) of C1 esterase inhibitor (C1INH-nf) administered intravenously (IV). If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
1203545|NCT00289211|O2|Outcome|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
1203546|NCT00289211|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
1203547|NCT00289211|O2|Outcome|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
1203548|NCT00289211|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
1203549|NCT00289211|O2|Outcome|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
1203550|NCT00289211|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
1203551|NCT00289211|O2|Outcome|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
1203552|NCT00289211|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
1203553|NCT00289211|O2|Outcome|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
1203554|NCT00289211|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
1203555|NCT00289211|O2|Outcome|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
1203556|NCT00289211|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
1203557|NCT00289211|E2|Reported Event|Placebo|
1203558|NCT00289211|E1|Reported Event|C1INH-nf|
1203559|NCT00289185|B3|Baseline|Total|Total of all reporting groups
1203560|NCT00289185|B2|Baseline|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203561|NCT00289185|B1|Baseline|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203562|NCT00289185|P2|Participant Flow|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203563|NCT00289185|P1|Participant Flow|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203564|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203565|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203566|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203567|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203568|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203569|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203570|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203571|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203572|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203573|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203574|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203575|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203576|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203577|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203578|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203579|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203837|NCT00288574|E1|Reported Event|Fluoxetine|"fluoxetine up to 80 mg per day~Fluoxetine"
1203580|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203581|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203582|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203583|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203584|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203585|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203586|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203587|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203588|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203589|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203590|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203591|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203592|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203593|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203594|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203595|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203596|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203838|NCT00288509|B1|Baseline|Dysport|250-1000 units
1203597|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203598|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203599|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in left anterolateral thigh, and the TETRActHib vaccine in the right anterolateral thigh.
1203600|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203601|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203602|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203603|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203604|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203605|NCT00289185|E2|Reported Event|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in left anterolateral thigh, and the TETRActHib vaccine in the right anterolateral thigh.
1203606|NCT00289185|E1|Reported Event|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1203607|NCT00289133|B3|Baseline|Total|Total of all reporting groups
1203608|NCT00289133|B2|Baseline|XLK Poly|Cross-linked polyethylene tibial insert total knee arthroplasty: cross-linked polyethylene tibial insert
1203609|NCT00289133|B1|Baseline|GVF Poly|Gamma Vacuum Foil polyethylene tibial insert total knee arthroplasty: Gamma Vacuum Foil polyethylene tibial insert
1203610|NCT00289133|P2|Participant Flow|XLK Poly|Cross-linked polyethylene tibial component
1203611|NCT00289133|P1|Participant Flow|GVF Poly|Gamma Vacuum Foil polyethylene tibial component
1203612|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene
1203613|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene
1203614|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene
1203615|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene
1203616|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene
1203617|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene
1203618|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene
1203619|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene
1203620|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene
1203621|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene
1203622|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene
1203623|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene
1203624|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene tibial component
1203625|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene tibial component
1203626|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene
1203627|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene
1203628|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene tibial insert total knee arthroplasty: cross-linked polyethylene tibial insert
1203629|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene tibial insert total knee arthroplasty: Gamma Vacuum Foil polyethylene tibial insert
1203630|NCT00289133|E2|Reported Event|XLK Poly|Cross-linked polyethylene tibial component
1203631|NCT00289133|E1|Reported Event|GVF Poly|Gamma Vacuum Foil polyethylene tibial component
1203632|NCT00289120|B1|Baseline|Cola First, Then Water|"Phase 1: Subjects will be given 500cc of Cola beverage twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet.~There will be a 3-week wash out period before subjects enter phase 2 of the study.~Phase 2: Subjects will be given 500 cc of deionized water beverage twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet."
1203839|NCT00288509|P1|Participant Flow|Dysport|250-1000 units
1203633|NCT00289120|P1|Participant Flow|Cola First, Then Water|"Phase 1: Subjects will be given 500cc of Cola beverage twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet.~There will be a three weeks wash-out period before patients entere phase 2 of thre study.~Phase 2: Subjects will be given 500cc of deionized water twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet."
1203634|NCT00289120|O2|Outcome|Cola|they ingested 500 mL of cola (regular Publix brand©) twice daily, with breakfast and dinner.
1203635|NCT00289120|O1|Outcome|Water|participants ingested 500 mL of deionized water twice daily, with breakfast and dinner.
1203636|NCT00289120|O2|Outcome|Water|participants ingested 500 mL of deionized water twice daily, with breakfast and dinner.
1203637|NCT00289120|O1|Outcome|Cola|they ingested 500 mL of cola (regular Publix brand©) twice daily, with breakfast and dinner.
1203638|NCT00289120|O2|Outcome|Cola|they ingested 500 mL of cola (regular Publix brand©) twice daily, with breakfast and dinner.
1203639|NCT00289120|O1|Outcome|Water|participants ingested 500 mL of deionized water twice daily, with breakfast and dinner.
1203640|NCT00289120|O2|Outcome|Cola|they ingested 500 mL of cola (regular Publix brand©) twice daily, with breakfast and dinner.
1203641|NCT00289120|O1|Outcome|Water|participants ingested 500 mL of deionized water twice daily, with breakfast and dinner.
1203642|NCT00289120|O2|Outcome|Cola|they ingested 500 mL of cola (regular Publix brand©) twice daily, with breakfast and dinner.
1203643|NCT00289120|O1|Outcome|Water|participants ingested 500 mL of deionized water twice daily, with breakfast and dinner.
1203644|NCT00289120|O2|Outcome|Water|participants ingested 500 mL of deionized water twice daily, with breakfast and dinner.
1203645|NCT00289120|O1|Outcome|Cola|they ingested 500 mL of cola (regular Publix brand©) twice daily, with breakfast and dinner.
1203646|NCT00289120|E2|Reported Event|Deionized Water Drinking Phase|"Subjects were given 500cc of regular deionized water twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet.~No adverse event reported."
1203939|NCT00287716|E1|Reported Event|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
1203647|NCT00289120|E1|Reported Event|Cola Beverage Phase|"Subjects were given 500cc of Cola twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet.~There will be a three weeks interval (wash out period) before crossover to the other treatment arm.~No adverse event reported."
1203648|NCT00289107|B3|Baseline|Total|Total of all reporting groups
1203649|NCT00289107|B2|Baseline|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
1203650|NCT00289107|B1|Baseline|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
1203651|NCT00289107|P2|Participant Flow|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
1203652|NCT00289107|P1|Participant Flow|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
1203653|NCT00289107|O2|Outcome|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
1203654|NCT00289107|O1|Outcome|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
1203655|NCT00289107|E2|Reported Event|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
1203656|NCT00289107|E1|Reported Event|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
1203657|NCT00289094|B3|Baseline|Total|Total of all reporting groups
1203658|NCT00289094|B2|Baseline|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
1203659|NCT00289094|B1|Baseline|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
1203660|NCT00289094|P2|Participant Flow|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
1203661|NCT00289094|P1|Participant Flow|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
1203662|NCT00289094|O2|Outcome|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
1203663|NCT00289094|O1|Outcome|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
1203664|NCT00289094|E2|Reported Event|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
1203665|NCT00289094|E1|Reported Event|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
1203666|NCT00289016|B1|Baseline|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
1203840|NCT00288509|O1|Outcome|Dysport|250-1000 units
1203841|NCT00288509|O1|Outcome|Dysport|250-1000 units
1203842|NCT00288509|O1|Outcome|Dysport|250-1000 units
1203843|NCT00288509|O1|Outcome|Dysport|250-1000 units
1203667|NCT00289016|P1|Participant Flow|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
1203668|NCT00289016|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
1203669|NCT00289016|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
1203670|NCT00289016|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
1203879|NCT00287872|P1|Participant Flow|Bortezomib and Thalidomide|"The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.~bortezomib~thalidomide"
1203671|NCT00289016|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
1203672|NCT00289016|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
1203673|NCT00289016|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
1203674|NCT00289016|E1|Reported Event|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
1203675|NCT00288912|B4|Baseline|Total|Total of all reporting groups
1203676|NCT00288912|B3|Baseline|Arm 3|"Osteoarthritis Self-Management~Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis."
1203677|NCT00288912|B2|Baseline|Arm 2|Usual Medical Care
1203678|NCT00288912|B1|Baseline|Arm 1|"Health Education Intervention~Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics."
1203679|NCT00288912|P3|Participant Flow|Arm 3|"Osteoarthritis Self-Management~Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis."
1203680|NCT00288912|P2|Participant Flow|Arm 2|Usual Medical Care
1203681|NCT00288912|P1|Participant Flow|Arm 1|"Health Education Intervention~Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics."
1203682|NCT00288912|O3|Outcome|Arm 3|"Osteoarthritis Self-Management~Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis."
1203683|NCT00288912|O2|Outcome|Arm 2|Usual Medical Care
1203684|NCT00288912|O1|Outcome|Arm 1|"Health Education Intervention~Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics."
1203685|NCT00288912|O3|Outcome|Arm 3|"Osteoarthritis Self-Management~Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis."
1203686|NCT00288912|O2|Outcome|Arm 2|Usual Medical Care
1203687|NCT00288912|O1|Outcome|Arm 1|"Health Education Intervention~Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics."
1203844|NCT00288509|E1|Reported Event|Dysport|250-1000 units
1203845|NCT00288080|B3|Baseline|Total|Total of all reporting groups
1203688|NCT00288912|O3|Outcome|Arm 3|"Osteoarthritis Self-Management~Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis."
1203689|NCT00288912|O2|Outcome|Arm 2|Usual Medical Care
1203690|NCT00288912|O1|Outcome|Arm 1|"Health Education Intervention~Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics."
1203691|NCT00288912|O3|Outcome|Arm 3|"Osteoarthritis Self-Management~Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis."
1203692|NCT00288912|O2|Outcome|Arm 2|Usual Medical Care
1203693|NCT00288912|O1|Outcome|Arm 1|"Health Education Intervention~Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics."
1203694|NCT00288912|E3|Reported Event|Arm 3|"Osteoarthritis Self-Management~Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis."
1203695|NCT00288912|E2|Reported Event|Arm 2|Usual Medical Care
1203696|NCT00288912|E1|Reported Event|Arm 1|"Health Education Intervention~Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics."
1203698|NCT00288886|B2|Baseline|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
1203699|NCT00288886|B1|Baseline|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
1203700|NCT00288886|P2|Participant Flow|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
1203701|NCT00288886|P1|Participant Flow|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
1203702|NCT00288886|O2|Outcome|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
1203703|NCT00288886|O1|Outcome|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
1203736|NCT00288704|P2|Participant Flow|Rilonacept 160 mg|"If assigned, subjects received rilonacept 160 mg during 1) the first 6 weeks of the study (Part A) or 2) during the randomized withdrawal period from weeks 15-24 (Part B). Note: Between weeks 6 and 15 (Parts A and B), all subjects received rilonacept 160 mg.~Study drug is administered as a 2.0 mL subcutaneous injection once a week. At baseline (week 0) subjects receive a loading dose of rilonacept 320 mg."
1203737|NCT00288704|P1|Participant Flow|Placebo|If assigned, subjects received Placebo during 1) the first 6 weeks of the study (Part A) or 2) during the randomized withdrawal period from weeks 15-24 (Part B). No subject received Placebo during the open-label extension (after week 24). The drug is administered subcutaneously on a weekly basis.
1203738|NCT00288704|O1|Outcome|Rilonacept 160 mg|
1203704|NCT00288886|O2|Outcome|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
1203705|NCT00288886|O1|Outcome|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
1203766|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
1203880|NCT00287872|O1|Outcome|Bortezomib and Thalidomide|"The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.~bortezomib~thalidomide"
1203981|NCT00287053|E1|Reported Event|1. Inactive Placebo Pill|Inactive placebo pill
1203706|NCT00288886|O2|Outcome|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
1203707|NCT00288886|O1|Outcome|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
1203708|NCT00288886|O2|Outcome|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
1203709|NCT00288886|O1|Outcome|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
1203710|NCT00288886|O2|Outcome|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
1203711|NCT00288886|O1|Outcome|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
1203712|NCT00288886|O2|Outcome|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
1203713|NCT00288886|O1|Outcome|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
1203739|NCT00288704|O1|Outcome|Rilonacept 160 mg|
1203740|NCT00288704|O1|Outcome|Rilonacept 160 mg|
1203741|NCT00288704|O2|Outcome|Rilonacept 160 mg|
1203742|NCT00288704|O1|Outcome|Placebo|
1203714|NCT00288886|O2|Outcome|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
1203715|NCT00288886|O1|Outcome|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
1203716|NCT00288886|E2|Reported Event|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
1203717|NCT00288886|E1|Reported Event|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
1203718|NCT00288860|B3|Baseline|Total|Total of all reporting groups
1203719|NCT00288860|B2|Baseline|Treatment-As-Usual|"Treatment as usual~Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)"
1203720|NCT00288860|B1|Baseline|Telephone Monitoring|"Telephone monitoring as augmentation to treatment as usual~Telephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)"
1203721|NCT00288860|P2|Participant Flow|Treatment-As-Usual|"Treatment as usual~Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)"
1203722|NCT00288860|P1|Participant Flow|Telephone Monitoring|"Telephone monitoring as augmentation to treatment as usual~Telephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)"
1203723|NCT00288860|O2|Outcome|Treatment-As-Usual|"Mental health Treatment As Usual, potentially including case management, pharmacotherapy, and individual and/or group psychotherapy.~TAU: Outpatient mental health Treatment As Usual (psychotherapy and/or medications)"
1203724|NCT00288860|O1|Outcome|Telephone Monitoring|"Biweekly monitoring and support by telephone (up to 6 calls over 3 months) as augmentation to mental health care as usual.~Telephone monitoring: Three months of biweekly telephone monitoring and support~TAU: Outpatient mental health Treatment As Usual (psychotherapy and/or medications)"
1203725|NCT00288860|O2|Outcome|Treatment-As-Usual|"Treatment as usual~Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)"
1203726|NCT00288860|O1|Outcome|Telephone Monitoring|"Telephone monitoring as augmentation to treatment as usual~Telephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)"
1203727|NCT00288860|O2|Outcome|Treatment as Usual|"Treatment as usual~Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)"
1203728|NCT00288860|O1|Outcome|Telephone Monitoring|"Telephone monitoring as augmentation to treatment as usual~Telephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)"
1203729|NCT00288860|E2|Reported Event|Treatment-As-Usual|"Treatment as usual~Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)"
1203730|NCT00288860|E1|Reported Event|Telephone Monitoring|"Telephone monitoring as augmentation to treatment as usual~Telephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)"
1203731|NCT00288704|B4|Baseline|Total|Total of all reporting groups
1203732|NCT00288704|B3|Baseline|Open-Label Rilonacept 160 mg|57 new subjects entered the study directly into the OLE. This was not part of the double blind or randomized withdrawal portion of the results. The 44 subjects who completed Parts A and B were not included in this category for baseline characteristics. Pediatric subjects , age 7 or older, received rilonacept dosed 2.2 mg/kg weekly up to 160 mg during the OLE.
1203733|NCT00288704|B2|Baseline|Rilonacept 160 mg|
1203734|NCT00288704|B1|Baseline|Placebo|
1203735|NCT00288704|P3|Participant Flow|Open-Label Extension (OLE) Rilonacept 160 mg|"After week 24 of study, all subjects received weekly injections of rilonacept 160 mg until the end of the study. This was not part of the double blind (Part A) or randomized withdrawal (Part B) portion of the results. Pediatric subjects received rilonacept dosed 2.2 mg/kg weekly up to 160 mg.~Study drug is administered as a 2.0 mL subcutaneous injection once a week."
1203743|NCT00288704|O2|Outcome|Rilonacept 160 mg|
1203744|NCT00288704|O1|Outcome|Placebo|
1203745|NCT00288704|O2|Outcome|Rilonacept 160 mg|
1203746|NCT00288704|O1|Outcome|Placebo|
1203747|NCT00288704|O2|Outcome|Rilonacept 160 mg|
1203748|NCT00288704|O1|Outcome|Placebo|
1203763|NCT00288639|B1|Baseline|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
1203764|NCT00288639|P1|Participant Flow|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
1203765|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
1203767|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
1203768|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
1203769|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
1203770|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
1203771|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
1203772|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
1203773|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
1203774|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
1203775|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
1203776|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
1203777|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
1203917|NCT00287716|O2|Outcome|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
1203778|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
1203779|NCT00288639|E1|Reported Event|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
1203780|NCT00288626|B1|Baseline|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to > 500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
1203781|NCT00288626|P1|Participant Flow|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥ 2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to > 500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
1203782|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
1203783|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
1203784|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
1203785|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
1203846|NCT00288080|B2|Baseline|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
1203786|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
1203787|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
1203877|NCT00288054|E1|Reported Event|Cetuximab + Chest Radiation Therapy|
1203788|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
1203789|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
1203790|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
1203791|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
1203792|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
1203847|NCT00288080|B1|Baseline|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
1203918|NCT00287716|O1|Outcome|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
1203919|NCT00287716|O3|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
1203793|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
1203794|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
1203795|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
1203796|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
1203797|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
1203798|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
1203799|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥ 2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
1203848|NCT00288080|P2|Participant Flow|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
1203800|NCT00288626|O1|Outcome|HDIT and HCT|Participants received Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to > 500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
1203801|NCT00288626|O1|Outcome|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until ≥2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to >500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
1203982|NCT00286754|B4|Baseline|Total|Total of all reporting groups
1203802|NCT00288626|E1|Reported Event|HDIT and HCT|Participants recv'd Granulocyte Colony Stimulating Factor (G-CSF) by injection for 4-5 days to increase the number of blood stem cells in the blood stream by mobilizing them from the bone marrow. Leukapheresis was performed until > 2.0 x 10^6 CD34+ hematopoietic progenitor cells (HPCs) per kg were collected and frozen for future use. After ≥7 days following the last G-CSF dose, patients were hospitalized and received high-dose immunosuppression (HDIT) and immunosuppressive agent thymoglobulin 2.5 mg/kg over the course of 6 days. HDIT consisted of carmustine 300mg/m^2, etoposide 200 mg/m^2 cytarabine 200 mg/m^2, and melphalan 140 mg/m^2. CD34+ HPCs were thawed and infused according to institutional best practice for blood component transfusion over approximately 30 minutes. Patients were hospitalized until recovery of ANC to > 500/uL for at least 2 days. Prednisone was administered (0.5 mg/kg/day) from Days 7 to 21 after HCT and tapered over 2 weeks to prevent engraftment syndrome.
1203803|NCT00288600|B3|Baseline|Total|Total of all reporting groups
1203804|NCT00288600|B2|Baseline|Control Group- Normal Saline|"Normal Saline solution and Phototherapy~Normal saline solution: Normal saline solution 10 ml/Kg"
1203805|NCT00288600|B1|Baseline|Experimental Group - Immunoglobulin|"Intravenous Immunoglobulin and Phototherapy~Intravenous Immunoglobulin: Intravenous Immunoglobulin"
1203806|NCT00288600|P2|Participant Flow|Control Group|"Normal Saline solution~Normal saline solution: Normal saline solution 10 ml/Kg"
1203807|NCT00288600|P1|Participant Flow|Experimental Group|"Intravenous Immunoglobulin~Intravenous Immunoglobulin: Intravenous Immunoglobulin"
1203808|NCT00288600|O2|Outcome|Control Group|"Normal Saline solution~Normal saline solution: Normal saline solution 10 ml/Kg"
1203809|NCT00288600|O1|Outcome|Experimental Group|"Intravenous Immunoglobulin~Intravenous Immunoglobulin: Intravenous Immunoglobulin"
1203810|NCT00288600|E2|Reported Event|Control Group|"Normal Saline solution~Normal saline solution: Normal saline solution 10 ml/Kg"
1203811|NCT00288600|E1|Reported Event|Experimental Group|"Intravenous Immunoglobulin~Intravenous Immunoglobulin: Intravenous Immunoglobulin"
1203812|NCT00288587|B3|Baseline|Total|Total of all reporting groups
1203813|NCT00288587|B2|Baseline|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
1203814|NCT00288587|B1|Baseline|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
1203815|NCT00288587|P2|Participant Flow|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
1203816|NCT00288587|P1|Participant Flow|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
1203817|NCT00288587|O2|Outcome|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
1203818|NCT00288587|O1|Outcome|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
1203819|NCT00288587|O2|Outcome|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
1203820|NCT00288587|O1|Outcome|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
1203821|NCT00288587|O2|Outcome|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
1203822|NCT00288587|O1|Outcome|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
1203823|NCT00288587|O2|Outcome|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
1203824|NCT00288587|O1|Outcome|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
1203825|NCT00288587|O2|Outcome|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
1203826|NCT00288587|O1|Outcome|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
1203827|NCT00288587|E2|Reported Event|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
1203828|NCT00288587|E1|Reported Event|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
1203829|NCT00288574|B3|Baseline|Total|Total of all reporting groups
1203849|NCT00288080|P1|Participant Flow|Androgen Suppression + Radiation Therapy (RT)|Androgen suppression (AS; luteinizing hormone-releasing hormone (LHRH) agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
1203850|NCT00288080|O2|Outcome|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
1203851|NCT00288080|O1|Outcome|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
1203852|NCT00288080|O2|Outcome|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
1203853|NCT00288080|O1|Outcome|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
1203854|NCT00288080|O2|Outcome|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
1203855|NCT00288080|O1|Outcome|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
1203856|NCT00288080|O2|Outcome|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
1203857|NCT00288080|O1|Outcome|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
1203858|NCT00288080|O2|Outcome|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
1203859|NCT00288080|O1|Outcome|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
1203860|NCT00288080|O2|Outcome|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
1203861|NCT00288080|O1|Outcome|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
1203862|NCT00288080|E2|Reported Event|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
1203863|NCT00288080|E1|Reported Event|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
1203864|NCT00288067|B1|Baseline|Fenretinide and Rituximab|"PHASE I: Patients receive fenretinide PO BID on days 1-5. Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8. Treatment continues in the absence of disease progression or unacceptable toxicity.~pharmacological study : Correlative studies~rituximab : Given IV~fenretinide : Given PO"
1203865|NCT00288067|P1|Participant Flow|Fenretinide and Rituximab|"PHASE I: Patients receive fenretinide PO BID on days 1-5. Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8. Treatment continues in the absence of disease progression or unacceptable toxicity.~pharmacological study : Correlative studies~rituximab : Given IV~fenretinide : Given PO"
1203866|NCT00288067|O2|Outcome|Fenretinide and Rituximab (Rituximab Pre Treated)|PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8.
1203867|NCT00288067|O1|Outcome|Fenretinide and Rituximab (Rituximab Naive)|PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8.
1203916|NCT00287716|O3|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
1204970|NCT00285584|B2|Baseline|Placebo|Participants in this arm received placebo.
1203868|NCT00288067|O1|Outcome|Fenretinide and Rituximab|"PHASE I: Patients receive fenretinide PO BID on days 1-5. Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8. Treatment continues in the absence of disease progression or unacceptable toxicity.~pharmacological study : Correlative studies~rituximab : Given IV~fenretinide : Given PO"
1203869|NCT00288067|E1|Reported Event|Fenretinide and Rituximab|"PHASE I: Patients receive fenretinide PO BID on days 1-5. Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8. Treatment continues in the absence of disease progression or unacceptable toxicity.~pharmacological study : Correlative studies~rituximab : Given IV~fenretinide : Given PO"
1203870|NCT00288054|B1|Baseline|Cohort 1: Cetuximab + Radiotherapy (no Docetaxel)|Eligible patients who began protocol treatment were included in the analysis.
1203871|NCT00288054|P1|Participant Flow|Cohort 1: Cetuximab + Radiotherapy (no Docetaxel)|Eligible patients who began protocol treatment were included in the analysis.
1203872|NCT00288054|O1|Outcome|Cohort 1: Cetuximab + Radiotherapy (no Docetaxel)|
1203873|NCT00288054|O1|Outcome|Cohort 1: Cetuximab + Radiotherapy (no Docetaxel)|
1203874|NCT00288054|O1|Outcome|Cohort 1: Cetuximab + Radiotherapy (no Docetaxel)|
1203875|NCT00288054|O1|Outcome|Cohort 1: Cetuximab + Radiotherapy (no Docetaxel)|Eligible patients who began protocol treatment were included in the analysis.
1203876|NCT00288054|O1|Outcome|Cetuximab + Chest Radiation Therapy|
1203881|NCT00287872|O1|Outcome|Bortezomib and Thalidomide|"The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.~bortezomib~thalidomide"
1203882|NCT00287872|E1|Reported Event|Bortezomib and Thalidomide|"The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.~bortezomib~thalidomide"
1203883|NCT00287729|B3|Baseline|Total|Total of all reporting groups
1203884|NCT00287729|B2|Baseline|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
1203885|NCT00287729|B1|Baseline|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
1203886|NCT00287729|P2|Participant Flow|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
1203887|NCT00287729|P1|Participant Flow|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
1203888|NCT00287729|O2|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
1203889|NCT00287729|O1|Outcome|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
1203890|NCT00287729|O2|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
1203891|NCT00287729|O1|Outcome|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
1203892|NCT00287729|O2|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
1203893|NCT00287729|O1|Outcome|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
1203894|NCT00287729|O2|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
1203895|NCT00287729|O1|Outcome|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
1203896|NCT00287729|O2|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
1203897|NCT00287729|O1|Outcome|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
1203898|NCT00287729|O2|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
1203899|NCT00287729|O1|Outcome|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
1203900|NCT00287729|O2|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
1203901|NCT00287729|O1|Outcome|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
1203902|NCT00287729|O2|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
1203903|NCT00287729|O1|Outcome|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
1203904|NCT00287729|E2|Reported Event|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
1203905|NCT00287729|E1|Reported Event|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
1203906|NCT00287716|B4|Baseline|Total|Total of all reporting groups
1203907|NCT00287716|B3|Baseline|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
1203908|NCT00287716|B2|Baseline|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
1203909|NCT00287716|B1|Baseline|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
1203910|NCT00287716|P3|Participant Flow|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
1203911|NCT00287716|P2|Participant Flow|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
1203912|NCT00287716|P1|Participant Flow|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
1203913|NCT00287716|O3|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
1203914|NCT00287716|O2|Outcome|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
1203915|NCT00287716|O1|Outcome|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
1203920|NCT00287716|O2|Outcome|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
1203921|NCT00287716|O1|Outcome|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
1203922|NCT00287716|O3|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
1203923|NCT00287716|O2|Outcome|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
1203924|NCT00287716|O1|Outcome|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
1203925|NCT00287716|O3|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
1203926|NCT00287716|O2|Outcome|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
1203927|NCT00287716|O1|Outcome|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
1203928|NCT00287716|O3|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
1203929|NCT00287716|O2|Outcome|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
1203930|NCT00287716|O1|Outcome|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
1203931|NCT00287716|O3|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
1203932|NCT00287716|O2|Outcome|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
1203933|NCT00287716|O1|Outcome|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
1203934|NCT00287716|O3|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
1203935|NCT00287716|O2|Outcome|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
1203936|NCT00287716|O1|Outcome|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
1203937|NCT00287716|E3|Reported Event|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
1203938|NCT00287716|E2|Reported Event|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
1203940|NCT00287365|B1|Baseline|Mildly Asthmatic Subjects With GSTM1 Null Genotype Compared to|"Mildly asthmatic subjects with GSTM1 null genotype compared to GSTM1 sufficient subjects~ozone: 2 hour exposure to 0.4 ppm ozone"
1203941|NCT00287365|P1|Participant Flow|Mildly Asthmatic Subjects With GSTM1 Null Genotype Compared to|"Mildly asthmatic subjects with GSTM1 null genotype compared to GSTM1 sufficient subjects~ozone: 2 hour exposure to 0.4 ppm ozone"
1203942|NCT00287365|O2|Outcome|GSTM1 Sufficient|GSTM1 sufficient mild asthmatics
1203943|NCT00287365|O1|Outcome|GSTM1 Null|GSTM1 null mild asthmatics
1203944|NCT00287365|O2|Outcome|GSTM Sufficient|GSTM1 sufficient mild asthmatics
1203945|NCT00287365|O1|Outcome|GSTM1 Null|GSTM1 null mild asthmatics
1203946|NCT00287365|E1|Reported Event|Mildly Asthmatic Subjects With GSTM1 Null Genotype Compared to|"Mildly asthmatic subjects with GSTM1 null genotype compared to GSTM1 sufficient subjects~ozone: 2 hour exposure to 0.4 ppm ozone"
1203947|NCT00287339|B3|Baseline|Total|Total of all reporting groups
1203948|NCT00287339|B2|Baseline|Placebo|Upon successful completion of the run-in period, participants randomized to receive to the placebo arm got a capsule identical to the esomeprazole arm, but containing an inert substance, twice daily for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner.
1203949|NCT00287339|B1|Baseline|Esomeprazole Arm|Upon successful completion of the run-in period, participants in the esomeprazole arm were given the compound at a dose of 40mg for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner. Esomeprazole was supplied by the investigational pharmacy at the University of North Carolina as blue capsules without identifying features.
1203950|NCT00287339|P2|Participant Flow|Placebo|Upon successful completion of the run-in period, participants randomized to receive to the placebo arm got a capsule identical to the esomeprazole arm, but containing an inert substance, twice daily for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner.
1203951|NCT00287339|P1|Participant Flow|Esomeprazole Arm|Upon successful completion of the run-in period, participants in the esomeprazole arm were given the compound at a dose of 40mg for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner. Esomeprazole was supplied by the investigational pharmacy at the University of North Carolina as blue capsules without identifying features.
1203952|NCT00287339|O2|Outcome|Placebo|Upon successful completion of the run-in period, participants randomized to receive to the placebo arm got a capsule identical to the esomeprazole arm, but containing an inert substance, twice daily for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner.
1203953|NCT00287339|O1|Outcome|Esomeprazole Arm|Upon successful completion of the run-in period, participants in the esomeprazole arm were given the compound at a dose of 40mg for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner. Esomeprazole was supplied by the investigational pharmacy at the University of North Carolina as blue capsules without identifying features.
1203954|NCT00287339|E2|Reported Event|Placebo|Upon successful completion of the run-in period, participants randomized to receive to the placebo arm got a capsule identical to the esomeprazole arm, but containing an inert substance, twice daily for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner.
1203955|NCT00287339|E1|Reported Event|Esomeprazole Arm|Upon successful completion of the run-in period, participants in the esomeprazole arm were given the compound at a dose of 40mg for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner. Esomeprazole was supplied by the investigational pharmacy at the University of North Carolina as blue capsules without identifying features.
1203956|NCT00287222|B1|Baseline|Bevacizumab and Erlotinib|Subjects will be treated with bevacizumab and erlotinib
1203957|NCT00287222|P1|Participant Flow|Bevacizumab and Erlotinib|Subjects will be treated with bevacizumab and erlotinib
1203958|NCT00287222|O1|Outcome|Bevacizumab and Erlotinib|Subjects will be treated with bevacizumab and erlotinib
1203959|NCT00287222|E1|Reported Event|Bevacizumab and Erlotinib|Subjects will be treated with bevacizumab and erlotinib
1203960|NCT00287079|B3|Baseline|Total|Total of all reporting groups
1203961|NCT00287079|B2|Baseline|No Treatment|Participants in this group did not receive any treatment.
1203962|NCT00287079|B1|Baseline|Rebif 44 Mcg|Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
1203963|NCT00287079|P2|Participant Flow|No Treatment|Participants in this group did not receive any treatment.
1203964|NCT00287079|P1|Participant Flow|Rebif 44 Mcg|Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
1203965|NCT00287079|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
1203966|NCT00287079|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
1203967|NCT00287079|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
1203968|NCT00287079|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
1203969|NCT00287079|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
1203970|NCT00287079|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
1203971|NCT00287079|E2|Reported Event|No Treatment|Participants in this group did not receive any treatment.
1203972|NCT00287079|E1|Reported Event|Rebif 44 Mcg|Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
1203973|NCT00287053|B3|Baseline|Total|Total of all reporting groups
1203974|NCT00287053|B2|Baseline|2. Active Medication|Active medication
1203975|NCT00287053|B1|Baseline|1. Inactive Placebo Pill|Inactive placebo pill
1203976|NCT00287053|P2|Participant Flow|2. Active Medication|Active medication
1203977|NCT00287053|P1|Participant Flow|1. Inactive Placebo Pill|Inactive placebo pill
1203978|NCT00287053|O2|Outcome|2. Active Medication|Active medication
1203979|NCT00287053|O1|Outcome|1. Inactive Placebo Pill|Inactive placebo pill
1203980|NCT00287053|E2|Reported Event|2. Active Medication|Active medication
1203984|NCT00286754|B2|Baseline|Health Education Intervention (HEI)|6 monthly calls of nontailored counseling for diet, medication and exercise
1203985|NCT00286754|B1|Baseline|Stage-Matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
1203986|NCT00286754|P3|Participant Flow|Usual Care (UC)|treatment as usual with no additional counseling
1203987|NCT00286754|P2|Participant Flow|Health Education Intervention (HEI)|6 monthly phone calls of non-tailored counseling for diet, medication and exercise
1203988|NCT00286754|P1|Participant Flow|Stage-matched Intervention (SM)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
1203989|NCT00286754|O3|Outcome|Usual Care (UC)|treatment as usual for hypertension
1203990|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 monthly calls of nontailored counseling for diet, medication and exercise
1203991|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
1203992|NCT00286754|O3|Outcome|Usual Care (UC)|treatment as usual for hypertension
1203993|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 monthly calls of nontailored counseling for diet, medication and exercise
1203994|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
1203995|NCT00286754|O3|Outcome|Usual Care (UC)|treatment as usual
1203996|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 monthly calls of nontailored counseling for diet, medication and exercise
1203997|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
1203998|NCT00286754|O3|Outcome|Usual Care (UC)|treatment as usual for hypertension
1203999|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 months of non-tailored counseling for diet, medication and exercise
1204000|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
1204001|NCT00286754|O3|Outcome|Usual Care (UC)|treatment as usual for hypertension
1204002|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 monthly calls of nontailored counseling for diet, medication and exercise
1204003|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
1204004|NCT00286754|O3|Outcome|Usual Care (UC)|Treatment as usual for hypertension with no counseling
1204005|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 monthly calls of non-tailored education about diet, medication and exercise recommendations
1204006|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly calls targeting diet, medication and exercise adherence tailored using the Transtheoretical Model
1204007|NCT00286754|O3|Outcome|Usual Care (UC)|treatment as usual for hypertension
1204008|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 monthly phone calls of nontailored counseling for diet, medication and exercise
1204009|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
1204010|NCT00286754|O3|Outcome|Usual Care (UC)|treatment as usual for hypertension
1204011|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 monthly calls of nontailored counseling for diet, medication and exercise
1204012|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
1204013|NCT00286754|O3|Outcome|Usual Care (UC)|treatment as usual for hypertension
1204014|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 monthly calls of nontailored counseling for diet, medication and exercise
1204015|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
1204016|NCT00286754|E3|Reported Event|Usual Care (UC)|treatment as usual for hypertension
1204017|NCT00286754|E2|Reported Event|Health Education Intervention (HEI)|6 monthly phone calls of nontailored counseling for diet, medication and exercise
1204018|NCT00286754|E1|Reported Event|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
1204019|NCT00286741|B3|Baseline|Total|Total of all reporting groups
1204020|NCT00286741|B2|Baseline|Arm 2|control
1204021|NCT00286741|B1|Baseline|Arm 1|"Medical group visits~Diabetes Group Management Visits: Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist."
1204022|NCT00286741|P2|Participant Flow|Control|control
1204023|NCT00286741|P1|Participant Flow|Medical Group Visits|"Medical group visits~Diabetes Group Management Visits: Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist."
1204024|NCT00286741|O2|Outcome|Treatment as Usual Control|control
1204025|NCT00286741|O1|Outcome|Medical Group Visits|"Medical group visits~Diabetes Group Management Visits: Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist."
1204026|NCT00286741|O2|Outcome|Control|Treatment as Usual Control
1204027|NCT00286741|O1|Outcome|Medical Group Visits|Diabetes Group Management Visits: Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist.
1204028|NCT00286741|E2|Reported Event|Control|Treatment as Usual Control
1204029|NCT00286741|E1|Reported Event|Medical Group Visits|Diabetes Group Management Visits: Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist.
1204030|NCT00286728|B3|Baseline|Total|Total of all reporting groups
1204031|NCT00286728|B2|Baseline|Arm 2 Usual Care|Usual care
1204032|NCT00286728|B1|Baseline|Arm 1 Intensive Referral|"Intensive referral to dual-focused self-help groups~Intensive referral to dual-focused self-help: 4 group sessions to introduce patients to dual focused groups"
1204033|NCT00286728|P2|Participant Flow|Arm 2 Usual Care|Usual care
1204034|NCT00286728|P1|Participant Flow|Arm 1 Intensive Referral|"Intensive referral to dual-focused self-help groups~Intensive referral to dual-focused self-help: 4 group sessions to introduce patients to dual focused groups"
1204035|NCT00286728|O2|Outcome|Arm 2 Usual Care|Usual care
1204036|NCT00286728|O1|Outcome|Arm 1 Intensive Referral|"Intensive referral to dual-focused self-help groups~Intensive referral to dual-focused self-help: 4 group sessions to introduce patients to dual focused groups"
1204037|NCT00286728|E2|Reported Event|Arm 2 Usual Care|Usual care
1204038|NCT00286728|E1|Reported Event|Arm 1 Intensive Referral|"Intensive referral to dual-focused self-help groups~Intensive referral to dual-focused self-help: 4 group sessions to introduce patients to dual focused groups"
1204039|NCT00286494|B4|Baseline|Total|Total of all reporting groups
1204040|NCT00286494|B3|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204041|NCT00286494|B2|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204042|NCT00286494|B1|Baseline|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204043|NCT00286494|P3|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204044|NCT00286494|P2|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204045|NCT00286494|P1|Participant Flow|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204046|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204047|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204048|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204049|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204050|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204051|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204052|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204053|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204054|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204214|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204055|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204056|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204057|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204058|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204059|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204060|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204061|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204062|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204063|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204064|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204065|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204066|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204067|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204068|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204069|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204070|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204071|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204072|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204073|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204074|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204075|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204076|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204077|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204078|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204079|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204080|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204081|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204082|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204083|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204084|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204085|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204086|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204087|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204088|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204089|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204090|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204091|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204092|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204093|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204094|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204095|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204096|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204097|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204098|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204099|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204100|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204101|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204102|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204103|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204104|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204105|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204106|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204107|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204108|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204109|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204110|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204111|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204112|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204113|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204114|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204115|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204116|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204117|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204118|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204119|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204120|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204121|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204122|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204123|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204124|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204125|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204126|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204127|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204128|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204129|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204130|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204131|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204132|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204133|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204134|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204135|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204136|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204137|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204138|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204139|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204140|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204141|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204142|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204143|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204144|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204145|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204146|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204147|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204148|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204149|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204150|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204151|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204152|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204153|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204154|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204155|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204156|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204157|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204158|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204159|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204160|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204161|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204162|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204163|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204164|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204165|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204166|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204167|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204168|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204169|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204170|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204171|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204172|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204173|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204174|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204175|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204176|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204177|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204178|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204179|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204180|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204181|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204182|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204183|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204184|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204185|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204186|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204187|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204188|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204189|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204190|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204191|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204192|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204193|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204194|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204195|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204196|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204197|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204198|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204199|NCT00286494|E3|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204200|NCT00286494|E2|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204201|NCT00286494|E1|Reported Event|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
1204202|NCT00286468|B4|Baseline|Total|Total of all reporting groups
1204203|NCT00286468|B3|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204204|NCT00286468|B2|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204205|NCT00286468|B1|Baseline|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204206|NCT00286468|P3|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204207|NCT00286468|P2|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204208|NCT00286468|P1|Participant Flow|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204209|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204210|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204211|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204212|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204213|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204215|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204216|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204217|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204218|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204219|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204220|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204221|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204222|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204223|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204224|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204225|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204226|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204227|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204228|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204229|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204230|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204231|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204232|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204233|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204234|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204235|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204236|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204238|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204239|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204240|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204241|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204242|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204243|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204244|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204245|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204246|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204247|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204248|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204249|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204250|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204251|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204252|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204253|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204254|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204255|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204256|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204257|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204258|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204259|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204260|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204261|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204262|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204263|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204264|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204265|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204266|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204267|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204268|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204269|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204270|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204271|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204272|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204273|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204274|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204275|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204276|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204277|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204278|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204279|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204280|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204281|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204282|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204283|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204284|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204285|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204286|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204287|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204288|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204289|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204290|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204291|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204292|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204293|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204294|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204295|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204296|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204297|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204298|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204299|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204300|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204301|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204302|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204303|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204304|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204305|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204306|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204307|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204308|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204309|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204310|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204311|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204312|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204313|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204314|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204315|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204316|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204317|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204318|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204319|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204320|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204321|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204322|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204323|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204324|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204325|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204326|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204327|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204328|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204329|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204330|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204331|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204332|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204333|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204334|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204335|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204336|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204337|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204338|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204339|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204340|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204341|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204342|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204343|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204344|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204345|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204346|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204347|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204348|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204349|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204350|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204351|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204352|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204353|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204354|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204355|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204356|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204357|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204358|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204359|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204360|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204361|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204362|NCT00286468|E3|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204363|NCT00286468|E2|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
1204364|NCT00286468|E1|Reported Event|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
1204365|NCT00286455|B4|Baseline|Total|Total of all reporting groups
1204366|NCT00286455|B3|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204367|NCT00286455|B2|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204971|NCT00285584|B1|Baseline|Bupropion|Participants in this arm received bupropion.
1204368|NCT00286455|B1|Baseline|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204369|NCT00286455|P3|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204370|NCT00286455|P2|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204371|NCT00286455|P1|Participant Flow|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204372|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204373|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204374|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204375|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204376|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204377|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204378|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204379|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204380|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204381|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204382|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204383|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204384|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204385|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204386|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204387|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204388|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204389|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204390|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204391|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204392|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204393|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204394|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204395|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204396|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204397|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204398|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204399|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204400|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204401|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204402|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204403|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204404|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204405|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204406|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204407|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204408|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204409|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204410|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204411|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204412|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204413|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204414|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204415|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204416|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204417|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204418|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204419|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204420|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204421|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204422|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204423|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204424|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204425|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204426|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204427|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204428|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204429|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204430|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204431|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204432|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204433|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204434|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204435|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204436|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204437|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204438|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204439|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204440|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204441|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204442|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204443|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204444|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204445|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204446|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204447|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204448|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204449|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204450|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204451|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204452|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204453|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204454|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204455|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204456|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204457|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204458|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204459|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204460|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204461|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204462|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204463|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204464|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204465|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204466|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204467|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204468|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204469|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204470|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204471|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204472|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204473|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204474|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204475|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204476|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204477|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204478|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204479|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204480|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204481|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204482|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204483|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204484|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204485|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204486|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204487|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204488|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204489|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204490|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204491|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204492|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204493|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204494|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204495|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204496|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204497|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204498|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204499|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204500|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204501|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204502|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204503|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204504|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204505|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204506|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204507|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204508|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204509|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204510|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204511|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204512|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204513|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204514|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204515|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204516|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204517|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204518|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204519|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204520|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204521|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204522|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204523|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204524|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204525|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204526|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204527|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204528|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204529|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204530|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204531|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204532|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204533|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204534|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204535|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204536|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204537|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204538|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204539|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204540|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204541|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204542|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204543|NCT00286455|E3|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
1204544|NCT00286455|E2|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
1204545|NCT00286455|E1|Reported Event|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
1204546|NCT00286442|B4|Baseline|Total|Total of all reporting groups
1204547|NCT00286442|B3|Baseline|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204548|NCT00286442|B2|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204549|NCT00286442|B1|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204550|NCT00286442|P3|Participant Flow|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204551|NCT00286442|P2|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204552|NCT00286442|P1|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204553|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204554|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204555|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204556|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204557|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204558|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204559|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204560|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204561|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204562|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204563|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204564|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204565|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204566|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204567|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204568|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204569|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204570|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204571|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204572|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204573|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204574|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204575|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204576|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204577|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204578|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204579|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204580|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204581|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204582|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204583|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204584|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204585|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204586|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204587|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204588|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204589|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204590|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204591|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204592|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204593|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204594|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204595|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204596|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204597|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204598|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204599|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204600|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204601|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204602|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204603|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204604|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204605|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204606|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204607|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204608|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204609|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204610|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204611|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204612|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204613|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204614|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204615|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204616|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204617|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204618|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204619|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204620|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204621|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204622|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204623|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204624|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204625|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204626|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204627|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204628|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204629|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204630|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204631|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204632|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204633|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204634|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204635|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204636|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204637|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204638|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204639|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204640|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204641|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204642|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204643|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204644|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204645|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204646|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204647|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204648|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204649|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204650|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204651|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204652|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204653|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204654|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204655|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204656|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204657|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204658|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204659|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204660|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204661|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204662|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204663|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204664|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204665|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204666|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204667|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204668|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204669|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204670|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204671|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204672|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204673|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204674|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204675|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204676|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204677|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204678|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204679|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204680|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204681|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204682|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204683|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204684|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204685|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204686|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204687|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204688|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204689|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204690|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204691|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204692|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204693|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204694|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204695|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204696|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204697|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204698|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204699|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204700|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204701|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204702|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204703|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204704|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204705|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204706|NCT00286442|E3|Reported Event|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
1204707|NCT00286442|E2|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204708|NCT00286442|E1|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
1204710|NCT00286429|B3|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204711|NCT00286429|B2|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204712|NCT00286429|B1|Baseline|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204713|NCT00286429|P3|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204714|NCT00286429|P2|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204715|NCT00286429|P1|Participant Flow|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204716|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204717|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204718|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204719|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204720|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204721|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204722|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204723|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204724|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204725|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204726|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204727|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204728|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204729|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204730|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204731|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204732|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204733|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204734|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204735|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204736|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204737|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204738|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204739|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204740|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204741|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204742|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204743|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204744|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204745|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204746|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204747|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204748|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204749|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204750|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204751|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204752|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204753|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204754|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204755|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204756|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204757|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204758|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204759|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204760|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204761|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204762|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204763|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204764|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204765|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204766|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204767|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204768|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204769|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204770|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204771|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204772|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204773|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204774|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204775|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204776|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204777|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204778|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204779|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204780|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204781|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204782|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204783|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204784|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204785|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204786|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204787|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204788|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204789|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204790|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204791|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204792|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204793|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204794|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204795|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204796|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204797|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204798|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204799|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204800|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204801|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204802|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204803|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204804|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204805|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204806|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204807|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204808|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204809|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204810|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204811|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204812|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204813|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204814|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204815|NCT00286429|E3|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204816|NCT00286429|E2|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
1204817|NCT00286429|E1|Reported Event|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
1204818|NCT00286325|B1|Baseline|Treated|Open label study subjects all treated with rituximab
1204819|NCT00286325|P1|Participant Flow|Treated|Open label study subjects all treated with rituximab
1204820|NCT00286325|O1|Outcome|Treated|Open label study subjects all treated with rituximab
1204821|NCT00286325|O1|Outcome|Treated|Open label study subjects all treated with rituximab
1204822|NCT00286325|O1|Outcome|Treated|Open label study subjects all treated with rituximab
1204823|NCT00286325|O1|Outcome|Treated|Open label study subjects all treated with rituximab
1204824|NCT00286325|O1|Outcome|Treated|Open label study subjects all treated with rituximab
1204825|NCT00286325|E1|Reported Event|Treated|Open label study subjects all treated with rituximab
1204826|NCT00286182|B3|Baseline|Total|Total of all reporting groups
1204827|NCT00286182|B2|Baseline|Placebo|"Placebo consists of saline injections.~Placebo: Placebo"
1204828|NCT00286182|B1|Baseline|Erythropoietin Alpha|Subcutaneous erythropoietin will be administered once weekly to achieve a target hemoglobin of 13 g/dL. Subjects will be dosed with the study drug for 24 weeks. The administration of study drug will be performed according to a pre-specified treatment algorithm that adjust erythropoietin dosages based on the rate of rise of the hemoglobin.
1204829|NCT00286182|P2|Participant Flow|Placebo|"Placebo consists of saline injections.~Placebo: Placebo"
1204830|NCT00286182|P1|Participant Flow|Erythropoietin Alpha|"Subcutaneous erythropoietin will be administered once weekly to achieve a target hemoglobin of 13 g/dL. Subjects will be dosed with the study drug for 24 weeks. The administration of study drug will be performed according to a pre-specified treatment algorithm that adjust erythropoietin dosages based on the rate of rise of the hemoglobin.~Erythropoietin alpha: Erythropoietin alpha is administered weekly by subcutaneous injection using a pre-specified dosing algorithm. The dosing algorithm is designed to make adjustments based on the rate of rise (ROR) of the hemoglobin over a one week period, as well as the absolute hemoglobin value. Subjects initially received active treatment with 7,500 units of erythropoietin given weekly by subcutaneously injection. Subjects are carefully monitored (e.g. every week) to avoid rapid increases in hemoglobin/hematocrit and/or increasing blood pressure control. Dose adjustments are made if the hemoglobin rises too rapidly (greater than 0.3 g/dL) in"
1204831|NCT00286182|O2|Outcome|Placebo|"Placebo consists of saline injections.~Placebo: Placebo"
1204859|NCT00286091|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
1204917|NCT00282828|P2|Participant Flow|Venlafaxine|Phase I non-responders randomized to this group switched to venlafaxine with flexible titration up to 225 mg/d.
1204832|NCT00286182|O1|Outcome|Erythropoietin Alpha|"Subcutaneous erythropoietin will be administered once weekly to achieve a target hemoglobin of 13 g/dL. Subjects will be dosed with the study drug for 24 weeks. The administration of study drug will be performed according to a pre-specified treatment algorithm that adjust erythropoietin dosages based on the rate of rise of the hemoglobin.~Erythropoietin alpha: Erythropoietin alpha is administered weekly by subcutaneous injection using a pre-specified dosing algorithm. The dosing algorithm is designed to make adjustments based on the rate of rise (ROR) of the hemoglobin over a one week period, as well as the absolute hemoglobin value. Subjects initially received active treatment with 7,500 units of erythropoietin given weekly by subcutaneously injection. Subjects are carefully monitored (e.g. every week) to avoid rapid increases in hemoglobin/hematocrit and/or increasing blood pressure control. Dose adjustments are made if the hemoglobin rises too rapidly (greater than 0.3 g/dL) in"
1204833|NCT00286182|E2|Reported Event|Placebo|"Placebo consists of saline injections.~Placebo: Placebo"
1204834|NCT00286182|E1|Reported Event|Erythropoietin Alpha|Subcutaneous erythropoietin will be administered once weekly to achieve a target hemoglobin of 13 g/dL. Subjects will be dosed with the study drug for 24 weeks. The administration of study drug will be performed according to a pre-specified treatment algorithm that adjust erythropoietin dosages based on the rate of rise of the hemoglobin.
1204835|NCT00286156|B4|Baseline|Total|Total of all reporting groups
1204836|NCT00286156|B3|Baseline|Standard Care|Standard Care: fluid intake primarily water of 2500-3000ml/24hrs, low sodium diet of 2300mg/24 hrs, caffeine avoidance, control of hypertension
1204837|NCT00286156|B2|Baseline|Low Dose Rapamycin (LD)|"Arm 2 Rapamune dose 2-6 mg aimed at maintaining trough levels of 2-5ng/ml~Rapamycin: Group 2 - doses of Rapamune aimed at maintaining trough levels 2-5ng/ml"
1204838|NCT00286156|B1|Baseline|Standard Rapamycin Dose (STD)|"Arm 1 Rapamune dose 2-6mg aimed at maintaining trough levels 5-8 ng/ml~Rapamycin: Group 1- doses of Rapamune aimed at maintaining trough levels 5-8ng/ml"
1204839|NCT00286156|P3|Participant Flow|Standard Care|Standard Care: fluid intake primarily water of 2500-3000ml/24hrs, low sodium diet of 2300mg/24 hrs, caffeine avoidance, control of hypertension
1204840|NCT00286156|P2|Participant Flow|Low Dose Rapamycin (LD)|"Arm 2 Rapamune dose 2-6 mg aimed at maintaining trough levels of 2-5ng/ml~Rapamycin: Group 2 - doses of Rapamune aimed at maintaining trough levels 2-5ng/ml"
1204841|NCT00286156|P1|Participant Flow|Standard Rapamycin Dose (STD)|"Arm 1 Rapamune dose 2-6mg aimed at maintaining trough levels 5-8 ng/ml~Rapamycin: Group 1- doses of Rapamune aimed at maintaining trough levels 5-8ng/ml"
1204842|NCT00286156|O3|Outcome|Standard Care|Standard Care: fluid intake primarily water of 2500-3000ml/24hrs, low sodium diet of 2300mg/24 hrs, caffeine avoidance, control of hypertension
1204843|NCT00286156|O2|Outcome|Low Dose Rapamycin (LD)|"Arm 2 Rapamune dose 2-6 mg aimed at maintaining trough levels of 2-5ng/ml~Rapamycin: Group 2 - doses of Rapamune aimed at maintaining trough levels 2-5ng/ml"
1204844|NCT00286156|O1|Outcome|Standard Rapamycin Dose (STD)|"Arm 1 Rapamune dose 2-6mg aimed at maintaining trough levels 5-8 ng/ml~Rapamycin: Group 1- doses of Rapamune aimed at maintaining trough levels 5-8ng/ml"
1204845|NCT00286156|O3|Outcome|Standard Care|Standard Care: fluid intake primarily water of 2500-3000ml/24hrs, low sodium diet of 2300mg/24 hrs, caffeine avoidance, control of hypertension
1204846|NCT00286156|O2|Outcome|Low Dose Rapamycin (LD)|"Arm 2 Rapamune dose 2-6 mg aimed at maintaining trough levels of 2-5ng/ml~Rapamycin: Group 2 - doses of Rapamune aimed at maintaining trough levels 2-5ng/ml"
1204847|NCT00286156|O1|Outcome|Standard Rapamycin Dose (STD)|"Arm 1 Rapamune dose 2-6mg aimed at maintaining trough levels 5-8 ng/ml~Rapamycin: Group 1- doses of Rapamune aimed at maintaining trough levels 5-8ng/ml"
1204848|NCT00286156|E3|Reported Event|Standard Care|Standard Care: fluid intake primarily water of 2500-3000ml/24hrs, low sodium diet of 2300mg/24 hrs, caffeine avoidance, control of hypertension
1204849|NCT00286156|E2|Reported Event|Low Dose Rapamycin (LD)|"Arm 2 Rapamune dose 2-6 mg aimed at maintaining trough levels of 2-5ng/ml~Rapamycin: Group 2 - doses of Rapamune aimed at maintaining trough levels 2-5ng/ml"
1204850|NCT00286156|E1|Reported Event|Standard Rapamycin Dose (STD)|"Arm 1 Rapamune dose 2-6mg aimed at maintaining trough levels 5-8 ng/ml~Rapamycin: Group 1- doses of Rapamune aimed at maintaining trough levels 5-8ng/ml"
1204851|NCT00286091|B3|Baseline|Total|Total of all reporting groups
1204852|NCT00286091|B2|Baseline|Denosumab|Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
1204853|NCT00286091|B1|Baseline|Placebo|Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
1204854|NCT00286091|P2|Participant Flow|Denosumab|Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
1204855|NCT00286091|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
1204856|NCT00286091|O2|Outcome|Denosumab|Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
1204857|NCT00286091|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
1204858|NCT00286091|O2|Outcome|Denosumab|Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
1204915|NCT00282828|B1|Baseline|Sertraline and Clonazepam|Participants will take both sertraline and clonazepam
1204916|NCT00282828|P3|Participant Flow|Sertraline and Placebo|Phase I non-responders randomized to this group received prolonged sertraline and placebo.
1204860|NCT00286091|O2|Outcome|Denosumab|Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
1204861|NCT00286091|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
1204862|NCT00286091|E4|Reported Event|OLE: Denosumab/ Denosumab 120 mg Q4W|Participants who received denosumab in the double-blind treatment phase received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
1204863|NCT00286091|E3|Reported Event|OLE: Placebo/ Denosumab 120 mg Q4W|Participants who received placebo in the double-blind treatment phase received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension (OLE) phase.
1204864|NCT00286091|E2|Reported Event|DB: Denosumab 120 mg Q4W|Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase.
1204865|NCT00286091|E1|Reported Event|DB: Placebo|Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind (DB) treatment phase.
1204866|NCT00286078|B3|Baseline|Total|Total of all reporting groups
1204867|NCT00286078|B2|Baseline|Control|"Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.~Precision: Implantable neurostimulator"
1204868|NCT00286078|B1|Baseline|Treatment|"Stimulation on~Precision: Implantable neurostimulator"
1204869|NCT00286078|P2|Participant Flow|Control|"Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.~Precision: Implantable neurostimulator"
1204870|NCT00286078|P1|Participant Flow|Treatment|"Stimulation on~Precision: Implantable neurostimulator"
1204871|NCT00286078|O2|Outcome|Control|"Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.~Precision: Implantable neurostimulator"
1204872|NCT00286078|O1|Outcome|Treatment|"Stimulation on~Precision: Implantable neurostimulator"
1204873|NCT00286078|O2|Outcome|Control|"Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.~Precision: Implantable neurostimulator"
1204874|NCT00286078|O1|Outcome|Treatment|"Stimulation on~Precision: Implantable neurostimulator"
1204875|NCT00286078|E2|Reported Event|Control|"Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.~Precision: Implantable neurostimulator"
1204876|NCT00286078|E1|Reported Event|Treatment|"Stimulation on~Precision: Implantable neurostimulator"
1204877|NCT00285246|B1|Baseline|All Participants|Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
1204878|NCT00285246|P1|Participant Flow|All Participants|Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
1204879|NCT00285246|O1|Outcome|All Participants|Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
1204880|NCT00285246|O1|Outcome|All Participants|Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
1204881|NCT00285246|O1|Outcome|All Participants|Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
1204882|NCT00285246|O1|Outcome|All Participants|Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
1204883|NCT00285246|E1|Reported Event|All Participants|Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
1204884|NCT00285207|B3|Baseline|Total|Total of all reporting groups
1204885|NCT00285207|B2|Baseline|A007|Experimental A007
1204886|NCT00285207|B1|Baseline|Placebo|Placebo (no treatment)
1204887|NCT00285207|P2|Participant Flow|A007|Experimental A007
1204888|NCT00285207|P1|Participant Flow|Placebo|Placebo (no treatment)
1204889|NCT00285207|O2|Outcome|A007|Experimental A007
1204890|NCT00285207|O1|Outcome|Placebo|Placebo (no treatment)
1204891|NCT00285207|E2|Reported Event|A007|Experimental A007
1204892|NCT00285207|E1|Reported Event|Placebo|Placebo (no treatment)
1204893|NCT00282867|B4|Baseline|Total|Total of all reporting groups
1204894|NCT00282867|B3|Baseline|Usual Care Group|target level 70 - 300 mg/dL
1204895|NCT00282867|B2|Baseline|Loose Control Group|target glucose level 70 – 200 mg/dL
1204896|NCT00282867|B1|Baseline|Tight Control Group|target glucose level 70-110 mg/dL
1204897|NCT00282867|P3|Participant Flow|Usual Care Group|target level 70 - 300 mg/dL
1204898|NCT00282867|P2|Participant Flow|Loose Control Group|target glucose level 70 – 200 mg/dL
1204899|NCT00282867|P1|Participant Flow|Tight Control Group|target glucose level 70-110 mg/dL
1204900|NCT00282867|O3|Outcome|Usual Care Group|target level 70 - 300 mg/dL
1204901|NCT00282867|O2|Outcome|Loose Control Group|target glucose level 70 – 200 mg/dL
1204902|NCT00282867|O1|Outcome|Tight Control Group|target glucose level 70-110 mg/dL
1204903|NCT00282867|O3|Outcome|Usual Care Group|target level 70 - 300 mg/dL
1204904|NCT00282867|O2|Outcome|Loose Control Group|target glucose level 70 – 200 mg/dL
1204905|NCT00282867|O1|Outcome|Tight Control Group|target glucose level 70-110 mg/dL
1204906|NCT00282867|O3|Outcome|Usual Care Group|target level 70 - 300 mg/dL
1204907|NCT00282867|O2|Outcome|Loose Control Group|target glucose level 70 – 200 mg/dL
1204908|NCT00282867|O1|Outcome|Tight Control Group|target glucose level 70-110 mg/dL
1204909|NCT00282867|O3|Outcome|Usual Care Group|target level 70 - 300 mg/dL
1204910|NCT00282867|O2|Outcome|Loose Control Group|target glucose level 70 – 200 mg/dL
1204911|NCT00282867|O1|Outcome|Tight Control Group|target glucose level 70-110 mg/dL
1204912|NCT00282828|B4|Baseline|Total|Total of all reporting groups
1204913|NCT00282828|B3|Baseline|Sertraline and Placebo|Participants will take both sertraline and placebo
1204914|NCT00282828|B2|Baseline|Venlafaxine|Participants will take venlafaxine only
1204918|NCT00282828|P1|Participant Flow|Sertraline and Clonazepam|Phase I non-responders randomized to this group remained on sertraline with the addition of clonazepam up to 3.0mg/d.
1204919|NCT00282828|O3|Outcome|Sertraline and Placebo|Phase I non-responders randomized to this group received prolonged sertraline and placebo.
1204920|NCT00282828|O2|Outcome|Venlafaxine|Phase I non-responders randomized to this group switched to venlafaxine with flexible titration up to 225 mg/d.
1204921|NCT00282828|O1|Outcome|Sertraline and Clonazepam|Phase I non-responders randomized to this group remained on sertraline with the addition of clonazepam up to 3.0mg/d.
1204922|NCT00282828|O3|Outcome|Sertraline and Placebo|Phase I non-responders randomized to this group received prolonged sertraline and placebo.
1204923|NCT00282828|O2|Outcome|Venlafaxine|Phase I non-responders randomized to this group switched to venlafaxine with flexible titration up to 225 mg/d.
1204924|NCT00282828|O1|Outcome|Sertraline and Clonazepam|Phase I non-responders randomized to this group remained on sertraline with the addition of clonazepam up to 3.0mg/d.
1204925|NCT00282828|E3|Reported Event|Sertraline and Placebo|Participants will take both sertraline and placebo
1204926|NCT00282828|E2|Reported Event|Venlafaxine|Participants will take venlafaxine only
1204927|NCT00282828|E1|Reported Event|Sertraline and Clonazepam|Participants will take both sertraline and clonazepam
1204928|NCT00282815|B3|Baseline|Total|Total of all reporting groups
1204929|NCT00282815|B2|Baseline|Sham Continuous Positive Airway Pressure (CPAP)|Subtherapeutic CPAP
1204930|NCT00282815|B1|Baseline|Active Continuous Positive Airway Pressure (CPAP)|
1204931|NCT00282815|P2|Participant Flow|Sham Continuous Positive Airway Pressure (CPAP)|Subtherapeutic CPAP
1204932|NCT00282815|P1|Participant Flow|Active Continuous Positive Airway Pressure (CPAP)|
1204933|NCT00282815|O2|Outcome|Sham Continuous Positive Airway Pressure (CPAP)|Subtherapeutic CPAP
1204934|NCT00282815|O1|Outcome|Active Continuous Positive Airway Pressure (CPAP)|
1204935|NCT00282815|O1|Outcome|After Randomization|
1204936|NCT00282815|O2|Outcome|Sham CPAP|
1204937|NCT00282815|O1|Outcome|Active CPAP|
1204938|NCT00282815|E2|Reported Event|Sham Continuous Positive Airway Pressure (CPAP)|Subtherapeutic CPAP
1204939|NCT00282815|E1|Reported Event|Active Continuous Positive Airway Pressure (CPAP)|
1204940|NCT00285857|B1|Baseline|Lovastatin|Lovastatin: 80 mg; 40 mg orally twice per day
1204941|NCT00285857|P1|Participant Flow|Lovastatin 80 mg/Day|Lovastatin 80 mg/day given as 40 mg orally twice per day
1204942|NCT00285857|O1|Outcome|Lovastatin 80 mg/Day|Lovastatin 80 mg/day given as 40 mg orally twice per day
1204943|NCT00285857|O1|Outcome|Lovastatin 80 mg/Day|Lovastatin 80 mg/day given as 40 mg orally twice per day
1204944|NCT00285857|O1|Outcome|Lovastatin 80 mg/Day|Lovastatin 80 mg/day given as 40 mg orally twice per day
1204945|NCT00285857|O5|Outcome|Baseline Biopsy Acellular|Those subjects whose pre-treatment evaluation by RPFNA (random periareolar fine needle aspiration) generated a sample that was acellular
1204946|NCT00285857|O4|Outcome|Baseline Carcinoma in Situ or Invasive Cancer (CIS/IC)|Those subjects whose pre-treatment evaluation by RPFNA (random periareolar fine needle aspiration) returned a diagnosis of carcinoma in situ or invasive cancer
1204947|NCT00285857|O3|Outcome|Baseline Proliferative Breast Disease With Atypia (PBD+A)|Those subjects whose pre-treatment evaluation by RPFNA (random periareolar fine needle aspiration) returned a diagnosis of proliferative breast disease with atypia
1204948|NCT00285857|O2|Outcome|Baseline Proliferative Breast Disease Without Atypia (PBD-A)|Those subjects whose pre-treatment evaluation by RPFNA (random periareolar fine needle aspiration) returned a diagnosis of proliferative breast disease without atypia
1204949|NCT00285857|O1|Outcome|Baseline Non-proliferative Breast Disease (NPBD)|Those subjects whose pre-treatment evaluation by RPFNA (random periareolar fine needle aspiration) returned a diagnosis of non-proliferative breast disease
1204950|NCT00285857|E1|Reported Event|Lovastatin|Lovastatin: 80 mg; 40 mg orally twice per day
1204951|NCT00285818|B3|Baseline|Total|Total of all reporting groups
1204952|NCT00285818|B2|Baseline|Placebo|"Patients receive a placebo pill one day before and for 5 additional days after starting ECT~Mifepristone: Mifepristone is a glucocorticoid receptor antagonist."
1204953|NCT00285818|B1|Baseline|Mifepristone|"Patients receive mifepristone one day before and for 5 additional days after starting ECT~Mifepristone: Mifepristone is a glucocorticoid receptor antagonist."
1204954|NCT00285818|P2|Participant Flow|Placebo|"Patients receive a placebo capsule one day before and for 5 additional days after starting ECT~Mifepristone: Mifepristone is a glucocorticoid receptor antagonist."
1204955|NCT00285818|P1|Participant Flow|Mifepristone|"Patients receive mifepristone one day before and for 5 additional days after starting ECT~Mifepristone: Mifepristone is a glucocorticoid receptor antagonist."
1204956|NCT00285818|O2|Outcome|Placebo|Patients receive a placebo pill one day before and for 5 additional days after starting ECT
1204957|NCT00285818|O1|Outcome|Mifepristone|"Patients receive mifepristone one day before and for 5 additional days after starting ECT~Mifepristone: Mifepristone is a glucocorticoid receptor antagonist."
1204958|NCT00285818|E2|Reported Event|Placebo|Patients receive a placebo pill one day before and for 5 additional days after starting ECT
1204959|NCT00285818|E1|Reported Event|Mifepristone|"Patients receive mifepristone one day before and for 5 additional days after starting ECT~Mifepristone: Mifepristone is a glucocorticoid receptor antagonist."
1204960|NCT00285779|B3|Baseline|Total|Total of all reporting groups
1204961|NCT00285779|B2|Baseline|Etanercept|Etanercept: etanercept 50 mg twice weekly for 12 weeks
1204962|NCT00285779|B1|Baseline|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
1204963|NCT00285779|P2|Participant Flow|Etanercept|Etanercept: etanercept 50 mg twice weekly for 12 weeks
1204964|NCT00285779|P1|Participant Flow|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
1204965|NCT00285779|O2|Outcome|Etanercept|Etanercept: etanercept 50 mg twice weekly for 12 weeks
1204966|NCT00285779|O1|Outcome|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
1204967|NCT00285779|E2|Reported Event|Etanercept|Etanercept: etanercept 50 mg twice weekly for 12 weeks
1204968|NCT00285779|E1|Reported Event|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
1204972|NCT00285584|P2|Participant Flow|Placebo|Participants in this arm received placebo.
1204973|NCT00285584|P1|Participant Flow|Bupropion|Participants in this arm received bupropion.
1204974|NCT00285584|O2|Outcome|Placebo|
1204975|NCT00285584|O1|Outcome|Bupropion|
1204976|NCT00285584|O2|Outcome|Placebo|Participants in this arm received placebo.
1204977|NCT00285584|O1|Outcome|Bupropion|Participants in this arm received bupropion.
1204978|NCT00285584|O2|Outcome|Placebo|
1204979|NCT00285584|O1|Outcome|Bupropion|
1204980|NCT00285584|O2|Outcome|Placebo|6 months
1204981|NCT00285584|O1|Outcome|Bupropion|6 months
1204982|NCT00285584|E2|Reported Event|Placebo|Participants in this arm received placebo.
1204983|NCT00285584|E1|Reported Event|Bupropion|Participants in this arm received bupropion.
1204984|NCT00285467|B3|Baseline|Total|Total of all reporting groups
1204985|NCT00285467|B2|Baseline|Cholecalciferol, Inactive Vitamin D|Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
1204986|NCT00285467|B1|Baseline|Doxercalciferol, Active Vitamin D|Doxercalciferol is an active Vitamin D readily usable by human body.
1204987|NCT00285467|P2|Participant Flow|Cholecalciferol, Inactive Vitamin D|Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
1204988|NCT00285467|P1|Participant Flow|Doxercalciferol, Active Vitamin D|Doxercalciferol is an active Vitamin D readily usable by human body.
1204989|NCT00285467|O2|Outcome|Cholecalciferol, Inactive Vitamin D|Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
1204990|NCT00285467|O1|Outcome|Doxercalciferol, Active Vitamin D|Doxercalciferol is an active Vitamin D readily usable by human body.
1204991|NCT00285467|O2|Outcome|Cholecalciferol, Inactive Vitamin D|Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
1204992|NCT00285467|O1|Outcome|Doxercalciferol, Active Vitamin D|Doxercalciferol is an active Vitamin D readily usable by human body.
1204993|NCT00285467|E2|Reported Event|Cholecalciferol, Inactive Vitamin D|Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
1204994|NCT00285467|E1|Reported Event|Doxercalciferol, Active Vitamin D|Doxercalciferol is an active Vitamin D readily usable by human body.
1204995|NCT00285012|B3|Baseline|Total|Total of all reporting groups
1204996|NCT00285012|B2|Baseline|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
1204997|NCT00285012|B1|Baseline|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
1204998|NCT00285012|P2|Participant Flow|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
1204999|NCT00285012|P1|Participant Flow|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
1205000|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
1205001|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
1205002|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
1205003|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
1205004|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
1205005|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
1205006|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
1205007|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
1205008|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
1205009|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
1205010|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
1205011|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
1205012|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
1205013|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
1205014|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
1205015|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
1205016|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
1205017|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
1205018|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
1205019|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
1205020|NCT00285012|E2|Reported Event|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
1205021|NCT00285012|E1|Reported Event|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
1205022|NCT00284934|B3|Baseline|Total|Total of all reporting groups
1205023|NCT00284934|B2|Baseline|High EC-MPS|Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
1205024|NCT00284934|B1|Baseline|Standard Dose EC-MPS|Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
1205025|NCT00284934|P2|Participant Flow|High EC-MPS|Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
1205026|NCT00284934|P1|Participant Flow|Standard Dose EC-MPS|Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
1205027|NCT00284934|O2|Outcome|High EC-MPS|Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
1205194|NCT00284518|B2|Baseline|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
1205028|NCT00284934|O1|Outcome|Standard Dose EC-MPS|Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
1205029|NCT00284934|O2|Outcome|High EC-MPS|Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
1205030|NCT00284934|O1|Outcome|Standard Dose EC-MPS|Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
1205031|NCT00284934|O2|Outcome|High EC-MPS|Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
1205032|NCT00284934|O1|Outcome|Standard Dose EC-MPS|Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
1205033|NCT00284934|O2|Outcome|High EC-MPS|Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
1205034|NCT00284934|O1|Outcome|Standard Dose EC-MPS|Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
1205035|NCT00284934|E2|Reported Event|High EC-MPS|Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
1205227|NCT00284518|O1|Outcome|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
1205036|NCT00284934|E1|Reported Event|Standard Dose EC-MPS|Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
1205037|NCT00284856|B4|Baseline|Total|Total of all reporting groups
1205038|NCT00284856|B3|Baseline|Placebo|Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
1205039|NCT00284856|B2|Baseline|Fluticasone|Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months
1205040|NCT00284856|B1|Baseline|Montelukast|Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
1205041|NCT00284856|P3|Participant Flow|Placebo|Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
1205042|NCT00284856|P2|Participant Flow|Fluticasone|Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months
1205043|NCT00284856|P1|Participant Flow|Montelukast|Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
1205044|NCT00284856|O3|Outcome|Placebo|Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
1205045|NCT00284856|O2|Outcome|Fluticasone|Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months
1205046|NCT00284856|O1|Outcome|Montelukast|Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
1205047|NCT00284856|O3|Outcome|Placebo|Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
1205048|NCT00284856|O2|Outcome|Fluticasone|Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months
1205049|NCT00284856|O1|Outcome|Montelukast|Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
1205050|NCT00284856|O3|Outcome|Placebo|Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
1205479|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
1205051|NCT00284856|O2|Outcome|Fluticasone|Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months
1205052|NCT00284856|O1|Outcome|Montelukast|Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
1205053|NCT00284856|E3|Reported Event|Placebo|Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
1205054|NCT00284856|E2|Reported Event|Fluticasone|Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months
1205055|NCT00284856|E1|Reported Event|Montelukast|Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
1205056|NCT00284739|B3|Baseline|Total|Total of all reporting groups
1205057|NCT00284739|B2|Baseline|Saline|Multiple normal saline injection into the abscess collection to improve percutaneous drainage
1205058|NCT00284739|B1|Baseline|Alteplase|Multiple Alteplase injection into the abscess collection to improve percutaneous drainage
1205059|NCT00284739|P2|Participant Flow|Saline|Multiple normal saline injection into the abscess collection to improve percutaneous drainage
1205060|NCT00284739|P1|Participant Flow|Alteplase|Multiple Alteplase injection into the abscess collection to improve percutaneous drainage
1205061|NCT00284739|O2|Outcome|Saline|Multiple normal saline injection into the abscess collection to improve percutaneous drainage
1205062|NCT00284739|O1|Outcome|Alteplase|Multiple Alteplase injection into the abscess collection to improve percutaneous drainage
1205063|NCT00284739|O2|Outcome|Saline|Multiple normal saline injection into the abscess collection to improve percutaneous drainage
1205064|NCT00284739|O1|Outcome|Alteplase|Multiple Alteplase injection into the abscess collection to improve percutaneous drainage
1205065|NCT00284739|O2|Outcome|Saline|Multiple normal saline injection into the abscess collection to improve percutaneous drainage
1205066|NCT00284739|O1|Outcome|Alteplase|Multiple Alteplase injection into the abscess collection to improve percutaneous drainage
1205067|NCT00284739|E2|Reported Event|Saline|Multiple normal saline injection into the abscess collection to improve percutaneous drainage
1205068|NCT00284739|E1|Reported Event|Alteplase|Multiple Alteplase injection into the abscess collection to improve percutaneous drainage
1205069|NCT00283296|B1|Baseline|Endeavor Wheelchair|Participants will receive an introduction to the Endeavor wheelchair, and will complete the Activities of Daily Living Course with their own personal wheelchair and with the Endeavor chair.
1205070|NCT00283296|P1|Participant Flow|Endeavor Wheelchair|All participants completed the Activities of Daily Living Course with their own personal wheelchair and with the Endeavor chair three times each. Testing was completed during a one-day visit that did not exceed 2 1/2 hours. For the in-home trial, subjects used the Endeavor as their primary means of mobility for two weeks and their own wheelchair for two weeks.
1205071|NCT00283296|O1|Outcome|Endeavor Wheelchair|For the in-home trial, subjects used the Endeavor as their primary means of mobility for two weeks and their own wheelchair for two weeks.
1205072|NCT00283296|O1|Outcome|Endeavor Wheelchair|For the in-home trial, subjects used the Endeavor as their primary means of mobility for two weeks and their own wheelchair for two weeks.
1205073|NCT00283296|O1|Outcome|Endeavor Wheelchair|All participants received an introduction to the Endeavor wheelchair, and completed the Activities of Daily Living Course with their own personal wheelchair and with the Endeavor chair.
1205074|NCT00283296|E1|Reported Event|Endeavor Wheelchair|Participants will receive an introduction to the Endeavor wheelchair, and will complete the Activities of Daily Living Course with their own personal wheelchair and with the Endeavor chair.
1205075|NCT00283244|B4|Baseline|Total|Total of all reporting groups
1205076|NCT00283244|B3|Baseline|Arm C (Gemcitabine + Erlotinib)|Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily
1205077|NCT00283244|B2|Baseline|Arm B (Erlotinib)|Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21.
1205078|NCT00283244|B1|Baseline|Arm A (Gemcitabine)|Patients receive gemcitabine hydrochloride 1200mg/m2 IV on days 1 and 8. Patients with progressive disease may cross over to arm B.
1205079|NCT00283244|P3|Participant Flow|Arm C (Gemcitabine + Erlotinib)|Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily
1205080|NCT00283244|P2|Participant Flow|Arm B (Erlotinib)|Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21.
1205081|NCT00283244|P1|Participant Flow|Arm A (Gemcitabine)|Patients receive gemcitabine hydrochloride 1200mg/m2 IV on days 1 and 8. Patients with progressive disease may cross over to arm B.
1205082|NCT00283244|O3|Outcome|Arm C (Gemcitabine + Erlotinib)|Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily
1205083|NCT00283244|O2|Outcome|Arm B (Erlotinib)|Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21.
1205084|NCT00283244|O1|Outcome|Arm A (Gemcitabine)|Patients receive gemcitabine hydrochloride 1200mg/m2 IV on days 1 and 8. Patients with progressive disease may cross over to arm B.
1205085|NCT00283244|O3|Outcome|Arm C (Gemcitabine + Erlotinib)|Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily
1205086|NCT00283244|O2|Outcome|Arm B (Erlotinib)|Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21.
1205087|NCT00283244|O1|Outcome|Arm A (Gemcitabine)|Patients receive gemcitabine hydrochloride 1200mg/m2 IV on days 1 and 8. Patients with progressive disease may cross over to arm B.
1205088|NCT00283244|O3|Outcome|Arm C (Gemcitabine + Erlotinib)|Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily
1205089|NCT00283244|O2|Outcome|Arm B (Erlotinib)|Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21.
1205090|NCT00283244|O1|Outcome|Arm A (Gemcitabine)|Patients receive gemcitabine hydrochloride 1200mg/m2 IV on days 1 and 8. Patients with progressive disease may cross over to arm B.
1205091|NCT00283244|O3|Outcome|Arm C (Gemcitabine + Erlotinib)|Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily
1205092|NCT00283244|O2|Outcome|Arm B (Erlotinib)|Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21.
1205093|NCT00283244|O1|Outcome|Arm A (Gemcitabine)|Patients receive gemcitabine hydrochloride 1200mg/m2 IV on days 1 and 8. Patients with progressive disease may cross over to arm B.
1205094|NCT00283244|O3|Outcome|Arm C (Gemcitabine + Erlotinib)|Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily
1205095|NCT00283244|O2|Outcome|Arm B (Erlotinib)|Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21
1205096|NCT00283244|O1|Outcome|Arm A (Gemcitabine)|Patients receive gemcitabine hydrochloride 1200mg/m2 IV on days 1 and 8. Patients with progressive disease may cross over to arm B.
1205097|NCT00283244|E3|Reported Event|Arm C (Gemcitabine + Erlotinib)|Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily
1205098|NCT00283244|E2|Reported Event|Arm B (Erlotinib)|Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21.
1205099|NCT00283244|E1|Reported Event|Arm A (Gemcitabine)|Patients receive gemcitabine hydrochloride 1200mg/m2 IV on days 1 and 8. Patients with progressive disease may cross over to arm B.
1205100|NCT00283075|B1|Baseline|All Participants|All participants who had at least one implantation of RENCA macrobeads, either at 8 RENCA macrobeads/kg body weight or 16 RENCA macrobeads/kg body weight.
1205101|NCT00283075|P2|Participant Flow|16 RENCA Macrobeads/kg Body Weight Implantation|RENCA macrobeads placement in abdominal cavity at 16 RENCA macrobeads/kg body weight.
1205102|NCT00283075|P1|Participant Flow|8 RENCA Macrobeads/kg Body Weight Implantation|RENCA macrobeads placement in abdominal cavity at 8 RENCA macrobeads/kg body weight.
1205103|NCT00283075|O2|Outcome|16 RENCA Macrobeads/kg Body Weight Implantation|RENCA macrobeads placement in abdominal cavity at 16 RENCA macrobeads/kg body weight.
1205104|NCT00283075|O1|Outcome|8 RENCA Macrobeads/kg Body Weight Implantation|RENCA macrobeads placement in abdominal cavity at 8 RENCA macrobeads/kg body weight.
1205105|NCT00283075|O4|Outcome|Day 28|Tumor marker response at Day 28 after the first implantation.
1205106|NCT00283075|O3|Outcome|Day 21|Tumor marker response at Day 21 after the first implantation.
1205107|NCT00283075|O2|Outcome|Day 14|Tumor marker response at Day 14 after the first implantation.
1205108|NCT00283075|O1|Outcome|Day 7|Tumor marker response at Day 7 after the first implantation.
1205109|NCT00283075|O1|Outcome|All Participants|All participants who had at least one implantation of RENCA macrobeads, either at 8 macrobeads/kg body weight or 16 macrobeads/kg body weight.
1205110|NCT00283075|O1|Outcome|All Participants|All participants who had at least one implantation of RENCA macrobeads, either at 8 RENCA macrobeads/kg body weight or 16 RENCA macrobeads/kg body weight.
1205111|NCT00283075|E1|Reported Event|All Participants|All participants who had at least one implantation of RENCA macrobeads, either at 8 macrobeads/kg body weight or 16 macrobeads/kg body weight.
1205112|NCT00283062|B5|Baseline|Total|Total of all reporting groups
1205113|NCT00283062|B4|Baseline|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
1205114|NCT00283062|B3|Baseline|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
1205115|NCT00283062|B2|Baseline|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
1205228|NCT00284518|O4|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
1205116|NCT00283062|B1|Baseline|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
1205117|NCT00283062|P4|Participant Flow|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
1205118|NCT00283062|P3|Participant Flow|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
1205119|NCT00283062|P2|Participant Flow|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
1205120|NCT00283062|P1|Participant Flow|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
1205121|NCT00283062|O4|Outcome|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
1205122|NCT00283062|O3|Outcome|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
1205123|NCT00283062|O2|Outcome|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
1205124|NCT00283062|O1|Outcome|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
1205195|NCT00284518|B1|Baseline|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
1205125|NCT00283062|O4|Outcome|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
1205126|NCT00283062|O3|Outcome|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
1205127|NCT00283062|O2|Outcome|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
1205128|NCT00283062|O1|Outcome|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
1205129|NCT00283062|O4|Outcome|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
1205130|NCT00283062|O3|Outcome|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
1205131|NCT00283062|O2|Outcome|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
1205132|NCT00283062|O1|Outcome|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
1205133|NCT00283062|O4|Outcome|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
1205134|NCT00283062|O3|Outcome|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
1205135|NCT00283062|O2|Outcome|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
1205136|NCT00283062|O1|Outcome|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
1205137|NCT00283062|O4|Outcome|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
1205138|NCT00283062|O3|Outcome|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
1205139|NCT00283062|O2|Outcome|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
1205140|NCT00283062|O1|Outcome|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
1205141|NCT00283062|O4|Outcome|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
1205142|NCT00283062|O3|Outcome|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
1205143|NCT00283062|O2|Outcome|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
1205144|NCT00283062|O1|Outcome|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
1205145|NCT00283062|E4|Reported Event|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
1205146|NCT00283062|E3|Reported Event|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
1205147|NCT00283062|E2|Reported Event|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
1205196|NCT00284518|P4|Participant Flow|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
1205148|NCT00283062|E1|Reported Event|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
1205149|NCT00283049|B4|Baseline|Total|Total of all reporting groups
1205150|NCT00283049|B3|Baseline|MET+SU + IG|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing additional prandial insulin therapy (HbA1c >6.5%)
1205151|NCT00283049|B2|Baseline|MET + TZD + IG|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a thiazolidinedione (TZD). Insulin glulisine will be added after Week 12 or later for those subjects needing additional prandial insulin therapy (HbA1c >6.5%)
1205152|NCT00283049|B1|Baseline|SU + TZD + IG|Arm 1: Insulin glargine(IG) administered subcutaneously once daily plus a sulfonylurea and a thiazolidinedione(TZD). Insulin glulisine will be added after Week 12 or later for those subjects needing additional prandial insulin therapy (HbA1c >6.5%)
1205153|NCT00283049|P3|Participant Flow|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
1205154|NCT00283049|P2|Participant Flow|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
1205155|NCT00283049|P1|Participant Flow|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
1205156|NCT00283049|O3|Outcome|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
1205157|NCT00283049|O2|Outcome|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
1205158|NCT00283049|O1|Outcome|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
1205159|NCT00283049|O3|Outcome|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
1205160|NCT00283049|O2|Outcome|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
1205161|NCT00283049|O1|Outcome|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
1205162|NCT00283049|O3|Outcome|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
1205163|NCT00283049|O2|Outcome|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
1205164|NCT00283049|O1|Outcome|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
1205165|NCT00283049|O3|Outcome|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
1205166|NCT00283049|O2|Outcome|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
1205167|NCT00283049|O1|Outcome|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
1205168|NCT00283049|O3|Outcome|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
1205169|NCT00283049|O2|Outcome|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
1205170|NCT00283049|O1|Outcome|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
1205171|NCT00283049|O3|Outcome|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
1205197|NCT00284518|P3|Participant Flow|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
1205172|NCT00283049|O2|Outcome|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
1205173|NCT00283049|O1|Outcome|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
1205174|NCT00283049|O3|Outcome|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
1205175|NCT00283049|O2|Outcome|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
1205176|NCT00283049|O1|Outcome|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
1205177|NCT00283049|E3|Reported Event|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
1205178|NCT00283049|E2|Reported Event|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
1205179|NCT00283049|E1|Reported Event|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
1205180|NCT00284557|B3|Baseline|Total|Total of all reporting groups
1205181|NCT00284557|B2|Baseline|Health Education Materials Only|Parent-child dyads allocated to Group 2 were provided with a standardized packet of health education materials addressing the recommended items from the expert committee guidelines (e.g., dietary recommendations using the Food Guide Pyramid and the Traffic Light Diet, a general prescription to increase physical activity to 60 minutes daily). They were also given a community resource list that provides contact and program information for community-based obesity treatment activities in their area.
1205182|NCT00284557|B1|Baseline|Group-based Behavioral Intervention|"The group-based behavioral intervention targets eating behaviors, physical activity, and screen time, and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter."
1205183|NCT00284557|P2|Participant Flow|Health Education Materials Only|Parent-child dyads allocated to Group 2 were provided with a standardized packet of health education materials addressing the recommended items from the expert committee guidelines (e.g., dietary recommendations using the Food Guide Pyramid and the Traffic Light Diet, a general prescription to increase physical activity to 60 minutes daily). They were also given a community resource list that provides contact and program information for community-based obesity treatment activities in their area.
1205184|NCT00284557|P1|Participant Flow|Group-based Behavioral Intervention|"The group-based behavioral intervention targets eating behaviors, physical activity, and screen time, and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter."
1205185|NCT00284557|O2|Outcome|Health Education Materials Only|Parent-child dyads allocated to Group 2 were provided with a standardized packet of health education materials addressing the recommended items from the expert committee guidelines (e.g., dietary recommendations using the Food Guide Pyramid and the Traffic Light Diet, a general prescription to increase physical activity to 60 minutes daily). They were also given a community resource list that provides contact and program information for community-based obesity treatment activities in their area.
1205186|NCT00284557|O1|Outcome|Group-based Behavioral Intervention|"The group-based behavioral intervention targets eating behaviors, physical activity, and screen time, and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter."
1205187|NCT00284557|O2|Outcome|Health Education Materials Only|Parent-child dyads allocated to Group 2 were provided with a standardized packet of health education materials addressing the recommended items from the expert committee guidelines (e.g., dietary recommendations using the Food Guide Pyramid and the Traffic Light Diet, a general prescription to increase physical activity to 60 minutes daily). They were also given a community resource list that provides contact and program information for community-based obesity treatment activities in their area.
1205188|NCT00284557|O1|Outcome|Group-based Behavioral Intervention|"The group-based behavioral intervention targets eating behaviors, physical activity, and screen time, and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter."
1205189|NCT00284557|E2|Reported Event|Health Education Materials Only|Parent-child dyads allocated to Group 2 were provided with a standardized packet of health education materials addressing the recommended items from the expert committee guidelines (e.g., dietary recommendations using the Food Guide Pyramid and the Traffic Light Diet, a general prescription to increase physical activity to 60 minutes daily). They were also given a community resource list that provides contact and program information for community-based obesity treatment activities in their area.
1205190|NCT00284557|E1|Reported Event|Group-based Behavioral Intervention|"The group-based behavioral intervention targets eating behaviors, physical activity, and screen time, and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter."
1205191|NCT00284518|B5|Baseline|Total|Total of all reporting groups
1205192|NCT00284518|B4|Baseline|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
1205193|NCT00284518|B3|Baseline|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
1205391|NCT00283842|B5|Baseline|Placebo|
1205198|NCT00284518|P2|Participant Flow|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
1205199|NCT00284518|P1|Participant Flow|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
1205200|NCT00284518|O4|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
1205201|NCT00284518|O3|Outcome|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
1205202|NCT00284518|O2|Outcome|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
1205203|NCT00284518|O1|Outcome|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
1205204|NCT00284518|O4|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
1205205|NCT00284518|O3|Outcome|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
1205206|NCT00284518|O2|Outcome|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
1205207|NCT00284518|O1|Outcome|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
1205208|NCT00284518|O4|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
1205209|NCT00284518|O3|Outcome|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
1205210|NCT00284518|O2|Outcome|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
1205211|NCT00284518|O1|Outcome|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
1205212|NCT00284518|O4|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
1205213|NCT00284518|O3|Outcome|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
1205214|NCT00284518|O2|Outcome|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
1205215|NCT00284518|O1|Outcome|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
1205216|NCT00284518|O4|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
1205217|NCT00284518|O3|Outcome|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
1205218|NCT00284518|O2|Outcome|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
1205219|NCT00284518|O1|Outcome|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
1205220|NCT00284518|O4|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
1205221|NCT00284518|O3|Outcome|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
1205222|NCT00284518|O2|Outcome|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
1205223|NCT00284518|O1|Outcome|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
1205224|NCT00284518|O4|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
1205225|NCT00284518|O3|Outcome|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
1205226|NCT00284518|O2|Outcome|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
1205229|NCT00284518|O3|Outcome|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
1205230|NCT00284518|O2|Outcome|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
1205231|NCT00284518|O1|Outcome|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
1205232|NCT00284518|E4|Reported Event|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
1205233|NCT00284518|E3|Reported Event|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
1205234|NCT00284518|E2|Reported Event|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
1205235|NCT00284518|E1|Reported Event|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
1205236|NCT00282984|B3|Baseline|Total|Total of all reporting groups
1205237|NCT00282984|B2|Baseline|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1205238|NCT00282984|B1|Baseline|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1205239|NCT00282984|P2|Participant Flow|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1205240|NCT00282984|P1|Participant Flow|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1205241|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1205242|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1205243|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1205244|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1205245|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1205246|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1205247|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1205248|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1205249|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1205250|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1205251|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1205252|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1205253|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1205254|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1205255|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1205256|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1205257|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1205258|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1205259|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1205260|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1205261|NCT00282984|E2|Reported Event|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1205262|NCT00282984|E1|Reported Event|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1205263|NCT00282971|B3|Baseline|Total|Total of all reporting groups
1205264|NCT00282971|B2|Baseline|Standard of Care|Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
1205265|NCT00282971|B1|Baseline|Inhaled Insulin|Inhaled insulin plus oral therapy
1205266|NCT00282971|P2|Participant Flow|Standard of Care|Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
1205267|NCT00282971|P1|Participant Flow|Inhaled Insulin|Inhaled insulin plus oral therapy
1205268|NCT00282971|O2|Outcome|Standard of Care|Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
1205269|NCT00282971|O1|Outcome|Inhaled Insulin|Inhaled insulin plus oral therapy
1205270|NCT00282971|O2|Outcome|Standard of Care|Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
1205271|NCT00282971|O1|Outcome|Inhaled Insulin|Inhaled insulin plus oral therapy
1205272|NCT00282971|O2|Outcome|Standard of Care|Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
1205273|NCT00282971|O1|Outcome|Inhaled Insulin|Inhaled insulin plus oral therapy
1205274|NCT00282971|E2|Reported Event|Standard of Care|Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
1205275|NCT00282971|E1|Reported Event|Inhaled Insulin|Inhaled insulin plus oral therapy
1205276|NCT00282919|B1|Baseline|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
1205277|NCT00282919|P1|Participant Flow|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
1205278|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
1205279|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
1205280|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
1205281|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
1205282|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
1205283|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
1205284|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
1205285|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
1205286|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
1205287|NCT00282919|E1|Reported Event|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
1205288|NCT00284180|B3|Baseline|Total|Total of all reporting groups
1205289|NCT00284180|B2|Baseline|Vinflunine/Trastuzumab|Vinflunine 280 mg/m2 every 21 days with trastuzumab administered with a loading dose of 8 mg/kg, followed by 6 mg/kg IV on day 1 of each subsequent cycle, repeated every 21 days. If no grade 3/4 adverse events were encountered after the first cycle, the dose could be escalated to 320 mg/m2
1205290|NCT00284180|B1|Baseline|Vinflunine|Vinflunine 320 mg/m2 intravenously day 1 over 20 minutes repeated every 21 days
1205291|NCT00284180|P2|Participant Flow|Vinflunine/Trastuzumab|Vinflunine 280 mg/m2 every 21 days with trastuzumab administered with a loading dose of 8 mg/kg, followed by 6 mg/kg IV on day 1 of each subsequent cycle, repeated every 21 days. If no grade 3/4 adverse events were encountered after the first cycle, the dose could be escalated to 320 mg/m2
1205292|NCT00284180|P1|Participant Flow|Vinflunine|Vinflunine 320 mg/m2 intravenously day 1 over 20 minutes repeated every 21 days
1205293|NCT00284180|O2|Outcome|Vinflunine/Trastuzumab|Vinflunine 280 mg/m2 every 21 days with trastuzumab administered with a loading dose of 8 mg/kg, followed by 6 mg/kg IV on day 1 of each subsequent cycle, repeated every 21 days. If no grade 3/4 adverse events were encountered after the first cycle of vinflunine/trastuzumab, the dose of vinflunine could be escalated to 320 mg/m2
1205294|NCT00284180|O1|Outcome|Vinflunine|Vinflunine 320 mg/m2 intravenously day 1 over 20 minutes repeated every 21 days
1205295|NCT00284180|E2|Reported Event|Vinflunine/Trastuzumab|
1205296|NCT00284180|E1|Reported Event|Vinflunine|
1205297|NCT00284154|B1|Baseline|Vinflunine|Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
1205298|NCT00284154|P1|Participant Flow|Vinflunine|Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
1205299|NCT00284154|O1|Outcome|Vinflunine|Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
1205300|NCT00284154|O1|Outcome|Vinflunine|Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
1205301|NCT00284154|O1|Outcome|Vinflunine|Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
1205302|NCT00284154|O1|Outcome|Vinflunine|Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
1205303|NCT00284154|E1|Reported Event|Vinflunine|Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
1205304|NCT00284141|B1|Baseline|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
1205305|NCT00284141|P1|Participant Flow|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
1205306|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
1205307|NCT00284141|O2|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by modified RECIST criteria.
1205308|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by Modified RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by RECIST criteria.
1205309|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
1205310|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
1205311|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
1205312|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
1205313|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
1205314|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
1205315|NCT00284141|O2|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by modified RECIST criteria.
1205316|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by Modified RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by RECIST criteria.
1205317|NCT00284141|O2|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by modified RECIST criteria.
1205318|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by Modified RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by RECIST criteria.
1205319|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
1205320|NCT00284141|O2|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by modified RECIST criteria.
1205321|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by Modified RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by RECIST criteria.
1205322|NCT00284141|E1|Reported Event|4 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
1205323|NCT00284089|B5|Baseline|Total|Total of all reporting groups
1205324|NCT00284089|B4|Baseline|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.5 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.36 years.
1205325|NCT00284089|B3|Baseline|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients enrolled in the extension phase received an intravitreal injection of 0.3 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.45 years.
1205343|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.3 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.45 years.
1205425|NCT00283816|O2|Outcome|Placebo|placebo pill in addition to oral contraceptive
1205326|NCT00284089|B2|Baseline|Group A: Ranibizumab 0.5 mg|In the single dose phase, all patients randomized in Group A received a single intravitreal injection of 0.5 mg of ranibizumab into the study eye. Those patients who successfully completed this phase entered the multiple dose phase, where they received an intravitreal injection of 0.5 mg of ranibizumab once a month for an additional 11 months. Subsequently Group A patients enrolling in the extension phase received an intravitreal injection of 0.5 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.93 years.
1205327|NCT00284089|B1|Baseline|Group A: Ranibizumab 0.3 mg|In the single dose phase, all patients randomized in Group A received a single intravitreal injection of 0.3 mg of ranibizumab into the study eye. Those patients who successfully completed this phase entered the multiple dose phase, where they received an intravitreal injection of 0.3 mg of ranibizumab once a month for an additional 11 months. Subsequently patients enrolling in the extension phase received an intravitreal injection of 0.3 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.70 years.
1205328|NCT00284089|P4|Participant Flow|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.5 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.36 years.
1205329|NCT00284089|P3|Participant Flow|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.3 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.45 years.
1205392|NCT00283842|B4|Baseline|Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg|400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
1205330|NCT00284089|P2|Participant Flow|Group A: Ranibizumab 0.5 mg|In the single dose phase, all patients randomized in Group A received a single intravitreal injection of 0.5 mg of ranibizumab into the study eye. Those patients who successfully completed this phase entered the multiple dose phase, where they received an intravitreal injection of 0.5 mg of ranibizumab once a month for an additional 11 months. Subsequently Group A patients enrolling in the extension phase received an intravitreal injection of 0.5 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.93 years.
1205331|NCT00284089|P1|Participant Flow|Group A: Ranibizumab 0.3 mg|In the single dose phase, all patients randomized in Group A received a single intravitreal injection of 0.3 mg of ranibizumab into the study eye. Those patients who successfully completed this phase entered the multiple dose phase, where they received an intravitreal injection of 0.3 mg of ranibizumab once a month for an additional 11 months. Subsequently patients enrolling in the extension phase received an intravitreal injection of 0.3 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.70 years.
1205332|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
1205333|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
1205334|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
1205335|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
1205336|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
1205337|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
1205338|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
1205339|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
1205340|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
1205341|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
1205342|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.5 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.36 years.
1205376|NCT00283868|B2|Baseline|Telephone|Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
1205426|NCT00283816|O1|Outcome|Metformin|metformin 2000mg in addition to oral contraceptive
1205344|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.5 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.36 years.
1205345|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.3 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.45 years.
1205346|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
1205347|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
1205348|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
1205349|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
1205350|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
1205351|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
1205393|NCT00283842|B3|Baseline|Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg|200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
1205352|NCT00284089|E4|Reported Event|Extension Group A+B: Ranibizumab 0.5 mg|In the extension phase, all patients received an intravitreal injection of 0.5 mg ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.36 years.
1205353|NCT00284089|E3|Reported Event|Extension Group A+B: Ranibizumab 0.3 mg|In the extension phase, enrolled patients received an intravitreal injection of 0.3 mg ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.45 years.
1205354|NCT00284089|E2|Reported Event|Core Group A+B: Ranibizumab 0.5 mg|“Core” means Single and Multiple Dose Phases. Group A patients received a single intravitreal injection of 0.5 mg of ranibizumab into the study eye, followed by 11 additional intravitreal injections of 0.5 mg of ranibizumab once a month. Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye.
1205355|NCT00284089|E1|Reported Event|Core Group A+B: Ranibizumab 0.3 mg|“Core” means Single and Multiple Dose Phases. Group A patients received a single intravitreal injection of 0.3 mg of ranibizumab into the study eye, followed by 11 additional intravitreal injections of 0.3 mg of ranibizumab once a month. Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye.
1205356|NCT00284050|B4|Baseline|Total|Total of all reporting groups
1205357|NCT00284050|B3|Baseline|Sham Injection|Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
1205358|NCT00284050|B2|Baseline|Ranibizumab 0.5 mg|Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
1205359|NCT00284050|B1|Baseline|Ranibizumab 0.3 mg|Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
1205360|NCT00284050|P3|Participant Flow|Sham Injection|Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
1205361|NCT00284050|P2|Participant Flow|Ranibizumab 0.5 mg|Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
1205377|NCT00283868|B1|Baseline|Telemedicine|Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
1205427|NCT00283816|O2|Outcome|Placebo|placebo pill in addition to oral contraceptive pill
1205362|NCT00284050|P1|Participant Flow|Ranibizumab 0.3 mg|Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
1205363|NCT00284050|O3|Outcome|Sham Injection|Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
1205364|NCT00284050|O2|Outcome|Ranibizumab 0.5 mg|Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
1205365|NCT00284050|O1|Outcome|Ranibizumab 0.3 mg|Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
1205394|NCT00283842|B2|Baseline|Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg|100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
1205480|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
1205366|NCT00284050|O3|Outcome|Sham Injection|Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
1205367|NCT00284050|O2|Outcome|Ranibizumab 0.5 mg|Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
1205368|NCT00284050|O1|Outcome|Ranibizumab 0.3 mg|Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
1205369|NCT00284050|O3|Outcome|Sham Injection|Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
1205370|NCT00284050|O2|Outcome|Ranibizumab 0.5 mg|Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
1205371|NCT00284050|O1|Outcome|Ranibizumab 0.3 mg|Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
1205372|NCT00284050|E3|Reported Event|Sham Injection|Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
1205373|NCT00284050|E2|Reported Event|Ranibizumab 0.5 mg|Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
1205374|NCT00284050|E1|Reported Event|Ranibizumab 0.3 mg|Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
1205375|NCT00283868|B3|Baseline|Total|Total of all reporting groups
1205378|NCT00283868|P2|Participant Flow|Telephone|Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
1205379|NCT00283868|P1|Participant Flow|Telemedicine|Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
1205380|NCT00283868|O2|Outcome|Telephone|Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
1205381|NCT00283868|O1|Outcome|Telemedicine|Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
1205382|NCT00283868|O2|Outcome|Telephone|Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
1205383|NCT00283868|O1|Outcome|Telemedicine|Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
1205384|NCT00283868|O2|Outcome|Telephone|Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
1205385|NCT00283868|O1|Outcome|Telemedicine|Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
1205386|NCT00283868|O2|Outcome|Telephone|Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
1205387|NCT00283868|O1|Outcome|Telemedicine|Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
1205388|NCT00283868|O2|Outcome|Telephone|Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
1205389|NCT00283868|O1|Outcome|Telemedicine|Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
1205390|NCT00283842|B6|Baseline|Total|Total of all reporting groups
1205395|NCT00283842|B1|Baseline|Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg|50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
1205396|NCT00283842|P5|Participant Flow|Placebo|
1205397|NCT00283842|P4|Participant Flow|Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg|400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
1205398|NCT00283842|P3|Participant Flow|Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg|200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
1205399|NCT00283842|P2|Participant Flow|Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg|100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
1205400|NCT00283842|P1|Participant Flow|Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg|50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
1205401|NCT00283842|O5|Outcome|Placebo|
1205402|NCT00283842|O4|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg|400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
1205403|NCT00283842|O3|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg|200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
1205404|NCT00283842|O2|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg|100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
1205405|NCT00283842|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg|50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
1205406|NCT00283842|O5|Outcome|Placebo|
1205407|NCT00283842|O4|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg|400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
1205408|NCT00283842|O3|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg|200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
1205409|NCT00283842|O2|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg|100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
1205410|NCT00283842|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg|50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
1205411|NCT00283842|E5|Reported Event|Placebo|
1205412|NCT00283842|E4|Reported Event|Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg|400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
1205413|NCT00283842|E3|Reported Event|Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg|200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
1205414|NCT00283842|E2|Reported Event|Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg|100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
1205415|NCT00283842|E1|Reported Event|Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg|50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
1205416|NCT00283816|B3|Baseline|Total|Total of all reporting groups
1205417|NCT00283816|B2|Baseline|Placebo|Subjects given a placebo in addition to oral contraceptive and lifestyle program
1205418|NCT00283816|B1|Baseline|Metformin|Subjects given 2000mg of metformin in addition to oral contraceptive and a lifestyle program
1205419|NCT00283816|P2|Participant Flow|Placebo|Subjects given a placebo in addition to oral contraceptive and lifestyle program
1205420|NCT00283816|P1|Participant Flow|Metformin|Subjects given 2000mg of metformin in addition to oral contraceptive and a lifestyle program
1205421|NCT00283816|O2|Outcome|Placebo|placebo pill in addition to oral contraceptive pill
1205422|NCT00283816|O1|Outcome|Metformin|2000mg of metformin in addition to oral contraceptive
1205423|NCT00283816|O2|Outcome|Placebo|placebo pill in addition to oral contraceptive pill
1205424|NCT00283816|O1|Outcome|Metformin|2000mg of metformin in addition to oral contraceptive
1205428|NCT00283816|O1|Outcome|Metformin|2000mg of metformin in addition to oral contraceptive
1205429|NCT00283816|E2|Reported Event|Placebo|Subjects given a placebo in addition to oral contraceptive and lifestyle program
1205430|NCT00283816|E1|Reported Event|Metformin|Subjects given 2000mg of metformin in addition to oral contraceptive and a lifestyle program
1205431|NCT00283712|B3|Baseline|Total|Total of all reporting groups
1205432|NCT00283712|B2|Baseline|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205433|NCT00283712|B1|Baseline|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205434|NCT00283712|P2|Participant Flow|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205435|NCT00283712|P1|Participant Flow|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205436|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205437|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205438|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205439|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205440|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205441|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205442|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205443|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205444|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205445|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205446|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205447|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205466|NCT00283712|E2|Reported Event|Placebo|Subjects randomized to the Placebo group
1205467|NCT00283712|E1|Reported Event|Infliximab|Subjects randomized to the Infliximab group
1205468|NCT00283686|B5|Baseline|Total|Total of all reporting groups
1205448|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205449|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205450|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205451|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205452|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205453|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205454|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205478|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
1205455|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205456|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205457|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205458|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205459|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205460|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205461|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205462|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205463|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205464|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205465|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
1205469|NCT00283686|B4|Baseline|ACE-I/Placebo and Low BP|"ACE-I + Placebo and low blood pressure control of 95-110/60-75 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve low blood pressure control of 95-110/60-75 mm Hg."
1205470|NCT00283686|B3|Baseline|ACE-I/Placebo and Standard BP|"ACE-I + Placebo and standard blood pressure control of 120-130/70-80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 120-130/70-80 mm Hg."
1205471|NCT00283686|B2|Baseline|ACE-I/ARB and Low BP|"ACE-I + ARB and low blood pressure control of 95-110/60-75 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve low blood pressure control of 95-110/60-75 mm Hg."
1205472|NCT00283686|B1|Baseline|ACE-I/ARB and Standard BP|"ACE-I + ARB and standard blood pressure control of 120-130/70-80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 120-130/70-80 mm Hg."
1205473|NCT00283686|P4|Participant Flow|ACE-I/Placebo and Low BP|"ACE-I + Placebo and low blood pressure control of 95-110/60-75 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve low blood pressure control of 95-110/60-75 mm Hg."
1205474|NCT00283686|P3|Participant Flow|ACE-I/Placebo and Standard BP|"ACE-I + Placebo and standard blood pressure control of 120-130/70-80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 120-130/70-80 mm Hg."
1205475|NCT00283686|P2|Participant Flow|ACE-I/ARB and Low BP|"ACE-I + angiotensin-receptor blocker (ARB) and low blood pressure control of 95-110/60-75 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve low blood pressure control of 95-110/60-75 mm Hg."
1205476|NCT00283686|P1|Participant Flow|ACE-I/ARB and Standard BP|"ACE-I + angiotensin-receptor blocker (ARB) and standard blood pressure control of 120-130/70-80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 120-130/70-80 mm Hg."
1205477|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
1205481|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
1205482|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
1205483|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
1205484|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
1205485|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
1205486|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
1205487|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
1205488|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
1205489|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
1205490|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
1205491|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
1205492|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
1205493|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
1205494|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
1205495|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
1205496|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
1205497|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
1205498|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
1205499|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
1205500|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
1205501|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
1205502|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
1205503|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
1205504|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
1205505|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
1205506|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
1205507|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
1205508|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
1205509|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
1205510|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
1205511|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
1205512|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
1205513|NCT00283686|E4|Reported Event|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
1205514|NCT00283686|E3|Reported Event|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
1205515|NCT00283686|E2|Reported Event|ACE-I Alone|ACE-I monotherapy (lisinopril only)
1205516|NCT00283686|E1|Reported Event|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
1205517|NCT00283595|B3|Baseline|Total|Total of all reporting groups
1205519|NCT00283595|B1|Baseline|Recombinant Human Growth Hormone Group|Treatment with rHGH
1205520|NCT00283595|P2|Participant Flow|Placebo (Subcutaneous Daily Injection)|Treatment with Placebo
1205521|NCT00283595|P1|Participant Flow|Recombinant Human Growth Hormone(Subcutaneous Daily Injection)|Treatment with rHGH
1205522|NCT00283595|O2|Outcome|Placebo Group|Treatment with Placebo
1205523|NCT00283595|O1|Outcome|Recombinant Human Growth Hormone Group|Treatment with rHGH
1205524|NCT00283595|O2|Outcome|Placebo Group|Treatment with Placebo
1205525|NCT00283595|O1|Outcome|Recombinant Human Growth Hormone Group|Treatment with rHGH
1205526|NCT00283595|E2|Reported Event|Placebo Group|Treatment with Placebo
1205527|NCT00283595|E1|Reported Event|Recombinant Human Growth Hormone Group|Treatment with rHGH
1205528|NCT00283439|B5|Baseline|Total|Total of all reporting groups
1205529|NCT00283439|B4|Baseline|Romiplostim 1000 µg|Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
1205530|NCT00283439|B3|Baseline|Romiplostim 700 µg|Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy
1205531|NCT00283439|B2|Baseline|Romiplostim 300 µg|Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy
1205532|NCT00283439|B1|Baseline|Romiplostim 100 µg|Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy
1205533|NCT00283439|P4|Participant Flow|Romiplostim 1000 µg|Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
1205534|NCT00283439|P3|Participant Flow|Romiplostim 700 µg|Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy
1205535|NCT00283439|P2|Participant Flow|Romiplostim 300 µg|Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy
1205536|NCT00283439|P1|Participant Flow|Romiplostim 100 µg|Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy
1205537|NCT00283439|O4|Outcome|Romiplostim 1000 µg|Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
1205538|NCT00283439|O3|Outcome|Romiplostim 700 µg|Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy
1205539|NCT00283439|O2|Outcome|Romiplostim 300 µg|Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy
1205540|NCT00283439|O1|Outcome|Romiplostim 100 µg|Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy
1205541|NCT00283439|O4|Outcome|Romiplostim 1000 µg|Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
1205603|NCT00282672|O1|Outcome|All Groups|
1205604|NCT00282672|O1|Outcome|All Groups|
1205542|NCT00283439|O3|Outcome|Romiplostim 700 µg|Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy
1205543|NCT00283439|O2|Outcome|Romiplostim 300 µg|Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy
1205544|NCT00283439|O1|Outcome|Romiplostim 100 µg|Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy
1205545|NCT00283439|O4|Outcome|Romiplostim 1000 µg|Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
1205546|NCT00283439|O3|Outcome|Romiplostim 700 µg|Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy
1205547|NCT00283439|O2|Outcome|Romiplostim 300 µg|Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy
1205548|NCT00283439|O1|Outcome|Romiplostim 100 µg|Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy
1205549|NCT00283439|O4|Outcome|Romiplostim 1000 µg|Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
1205550|NCT00283439|O3|Outcome|Romiplostim 700 µg|Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy
1205551|NCT00283439|O2|Outcome|Romiplostim 300 µg|Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy
1205552|NCT00283439|O1|Outcome|Romiplostim 100 µg|Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy
1205553|NCT00283439|E4|Reported Event|Romiplostim 1000 µg|
1205554|NCT00283439|E3|Reported Event|Romiplostim 700 µg|
1205555|NCT00283439|E2|Reported Event|Romiplostim 300 µg|
1205556|NCT00283439|E1|Reported Event|Romiplostim 100 µg|
1205557|NCT00283400|B5|Baseline|Total|Total of all reporting groups
1205558|NCT00283400|B4|Baseline|Dosage Tier 4|25% human albumin 2.5 g/kg
1205559|NCT00283400|B3|Baseline|Dosage Tier 3|25% human albumin 1.875 g/kg
1205560|NCT00283400|B2|Baseline|Dosage Tier 2|25% human albumin 1.25 g/kg
1205561|NCT00283400|B1|Baseline|Dosage Tier 1|25% human albumin 0.625 g/kg
1205562|NCT00283400|P4|Participant Flow|Dosage Tier 4|25% human albumin2.5 g/kg
1205563|NCT00283400|P3|Participant Flow|Dosage Tier 3|25% human albumin 1.875 g/kg
1205564|NCT00283400|P2|Participant Flow|Dosage Tier 2|25% human albumin 1.25 g/kg
1205565|NCT00283400|P1|Participant Flow|Dosage Tier 1|25% human albumin 0.625 g/kg
1205566|NCT00283400|O4|Outcome|Dosage Tier 4|25% human albumin 2.5 g/kg
1205567|NCT00283400|O3|Outcome|Dosage Tier 3|25% human albumin 1.875 g/kg
1205568|NCT00283400|O2|Outcome|Dosage Tier 2|25% human albumin 1.25 g/kg
1205569|NCT00283400|O1|Outcome|Dosage Tier 1|25% human albumin 0.625 g/kg
1205570|NCT00283400|O4|Outcome|Dosage Tier 4|25% human albumin 2.5 g/kg
1205571|NCT00283400|O3|Outcome|Dosage Tier 3|25% human albumin 1.875 g/kg
1205572|NCT00283400|O2|Outcome|Dosage Tier 2|25% human albumin 1.25 g/kg
1205573|NCT00283400|O1|Outcome|Dosage Tier 1|25% human albumin 0.625 g/kg
1205574|NCT00283400|O4|Outcome|Dosage Tier 4|25% human albumin 2.5 g/kg
1205575|NCT00283400|O3|Outcome|Dosage Tier 3|25% human albumin 1.875 g/kg
1205576|NCT00283400|O2|Outcome|Dosage Tier 2|25% human albumin 1.25 g/kg
1205577|NCT00283400|O1|Outcome|Dosage Tier 1|25% human albumin 0.625 g/kg
1205578|NCT00283400|E4|Reported Event|Dosage Tier 4|25% human albumin 2.5 g/kg
1205579|NCT00283400|E3|Reported Event|Dosage Tier 3|25% human albumin 1.875 g/kg
1205580|NCT00283400|E2|Reported Event|Dosage Tier 2|25% human albumin 1.25 g/kg
1205581|NCT00283400|E1|Reported Event|Dosage Tier 1|25% human albumin 0.625 g/kg
1205582|NCT00283387|B1|Baseline|Entire Study Population|Includes groups randomized to receive placebo first and betaine first.
1205583|NCT00283387|P2|Participant Flow|Placebo First, Then Betaine|Subjects received oral lactose placebo divided in two doses daily, for 2 months, followed by a 2 month washout period. Subjects then received oral betaine 10 gm (subjects >10 yrs old) or 6 gm (subjects <10 yrs old), divided in two doses daily, for 2 months.
1205584|NCT00283387|P1|Participant Flow|Betaine First, Then Placebo|Subjects received oral betaine 10 gm (subjects >10 yrs old) or 6 gm (subjects <10 yrs old) divided in two doses daily, for 2 months, followed by a 2 month washout period. Subjects then received oral lactose placebo divided in two doses daily, for 2 months.
1205585|NCT00283387|O2|Outcome|Placebo|Subjects received oral lactose placebo divided in two doses daily, for 2 months.
1205586|NCT00283387|O1|Outcome|Betaine|Subjects received oral betaine 10 gm (subjects >10 yrs old) or 6 gm (subjects <10 yrs old), divided in two doses daily, for 2 months.
1205587|NCT00283387|E2|Reported Event|Placebo|Subjects received oral lactose placebo divided in two doses daily, for 2 months.
1205588|NCT00283387|E1|Reported Event|Betaine|Subjects received oral betaine 10 gm (subjects >10 yrs old) or 6 gm (subjects <10 yrs old), divided in two doses daily, for 2 months.
1205589|NCT00282672|B5|Baseline|Total|Total of all reporting groups
1205590|NCT00282672|B4|Baseline|HGD Radiofrequency Ablation|
1205591|NCT00282672|B3|Baseline|HGD Sham Procedure First Then LGD Radiofrequency Ablation|After the 1 year follow up was completed, all sham patients were offered cross-over to receive RFA.
1205592|NCT00282672|B2|Baseline|LGD Radiofrequency Ablation|
1205593|NCT00282672|B1|Baseline|LGD Sham Procedure First Then LGD Radiofrequency Ablation|After the 1 year follow up was completed, all sham patients were offered cross-over to receive RFA.
1205594|NCT00282672|P4|Participant Flow|HGD Radiofrequency Ablation|
1205595|NCT00282672|P3|Participant Flow|HGD Sham Procedure First Then HGD Radiofrequency Ablation|After the 1 year follow up was completed, all sham patients were offered cross-over to receive RFA.
1205596|NCT00282672|P2|Participant Flow|LGD Radiofrequency Ablation|
1205597|NCT00282672|P1|Participant Flow|LGD Sham Procedure First Then LGD Radiofrequency Ablation|After the 1 year follow up was completed, all sham patients were offered cross-over to receive RFA.
1205598|NCT00282672|O2|Outcome|All HGD Patients|
1205599|NCT00282672|O1|Outcome|All LGD Patients|
1205600|NCT00282672|O1|Outcome|All Groups|
1205601|NCT00282672|O1|Outcome|All Study Participants|
1205602|NCT00282672|O1|Outcome|All Groups|
1205611|NCT00282672|O3|Outcome|HGD Sham Procedure First Then HGD Radiofrequency Ablation|
1205612|NCT00282672|O2|Outcome|LGD Radiofrequency Ablation|
1205613|NCT00282672|O1|Outcome|LGD Sham Procedure First Then LGD Radiofrequency Ablation|
1205614|NCT00282672|O1|Outcome|All Groups|
1205615|NCT00282672|O3|Outcome|HGD to IMC|
1205616|NCT00282672|O2|Outcome|LGD to IMC|
1205617|NCT00282672|O1|Outcome|LGD to HGD|
1205618|NCT00282672|O4|Outcome|HGD Sham Procedure First Then HGD Radiofrequency Ablation|
1205619|NCT00282672|O3|Outcome|HGD Radiofrequency Ablation|
1205620|NCT00282672|O2|Outcome|LGD Sham Procedure First Then LGD Radiofrequency Ablation|
1205621|NCT00282672|O1|Outcome|LGD Radiofrequency Ablation|
1205622|NCT00282672|O2|Outcome|HGD Sham Procedure First Then HGD Radiofrequency Ablation|
1205623|NCT00282672|O1|Outcome|HGD Radiofrequency Ablation|
1205624|NCT00282672|O4|Outcome|HGD Sham Procedure First Then HGD Radiofrequency Ablation|
1205625|NCT00282672|O3|Outcome|HGD Radiofrequency Ablation|
1205626|NCT00282672|O2|Outcome|LGD Sham Procedure First Then LGD Radiofrequency Ablation|
1205627|NCT00282672|O1|Outcome|LGD Radiofrequency Ablation|
1205628|NCT00282672|O2|Outcome|All HGD Patients|HGD: Sham procedure group crossed over to HGD: Radiofrequency group at 12 month
1205629|NCT00282672|O1|Outcome|All LGD Patients|LGD: Sham procedure group crossed over to LGD: Radiofrequency group at 12 month
1205630|NCT00282672|O4|Outcome|HGD Radiofrequency Ablation|
1205631|NCT00282672|O3|Outcome|HGD Sham Procedure First Then HGD Radiofrequency Ablation|Crossed over to HGD: Radiofrequency
1205632|NCT00282672|O2|Outcome|LGD:Radiofrequency|
1205633|NCT00282672|O1|Outcome|LGD Sham Procedure First Then LGD Radiofrequency Ablation|Crossed over to LGD:Radiofrequency
1205634|NCT00282672|O2|Outcome|HGD:Radiofrequency|
1205635|NCT00282672|O1|Outcome|LGD:Radiofrequency|
1205636|NCT00282672|O2|Outcome|HGD:Radiofrequency Ablation|
1205637|NCT00282672|O1|Outcome|LGD:Radiofrequency Ablation|
1205638|NCT00282672|E4|Reported Event|HGD Radiofrequency Ablation|
1205639|NCT00282672|E3|Reported Event|HGD Sham Procedure First Then HGD Radiofrequency Ablation|
1205640|NCT00282672|E2|Reported Event|LGD Radiofrequency Ablation|
1205641|NCT00282672|E1|Reported Event|LGD Sham Procedure First Then LGD Radiofrequency Ablation|
1205642|NCT00282568|B1|Baseline|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
1205722|NCT00282438|O2|Outcome|Allogeneic Stem Cell Transplantation|"Allogeneic stem cells will be injected after conditioning~Allogeneic stem cell transplantation: Allogeneic stem cells will be injected after conditioning"
1205643|NCT00282568|P1|Participant Flow|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
1205644|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
1205645|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
1205646|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
1205647|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
1205648|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
1205649|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
1205650|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
1205651|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
1205652|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
1205719|NCT00282438|B1|Baseline|Autologous Hematopoietic Stem Cell Transplantation|"Autologous stem cells will be injected after conditioning~Autologous hematopoietic stem cell transplantation: Autologous hematopoietic stem cells will be injected after conditioning"
1205653|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
1205654|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
1205655|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
1205656|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
1205657|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
1205658|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
1205659|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
1205660|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
1205661|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
1205662|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
1205720|NCT00282438|P2|Participant Flow|Allogeneic Stem Cell Transplantation|"Allogeneic stem cells will be injected after conditioning~Allogeneic stem cell transplantation: Allogeneic stem cells will be injected after conditioning"
1205663|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
1205664|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
1205665|NCT00282568|E1|Reported Event|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
1205666|NCT00282464|B3|Baseline|Total|Total of all reporting groups
1205667|NCT00282464|B2|Baseline|Placebo|
1205668|NCT00282464|B1|Baseline|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
1205669|NCT00282464|P2|Participant Flow|Placebo|
1205670|NCT00282464|P1|Participant Flow|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
1205671|NCT00282464|O2|Outcome|Placebo|
1205735|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
1206628|NCT00280917|P1|Participant Flow|CF101 0.1mg|CF101 0.1 mg q12 hours orally
1205672|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
1205673|NCT00282464|O2|Outcome|Placebo|
1205674|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
1205675|NCT00282464|O2|Outcome|Placebo|
1205676|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
1205677|NCT00282464|O2|Outcome|Placebo|
1205678|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
1205679|NCT00282464|O2|Outcome|Placebo|
1205680|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
1205681|NCT00282464|O2|Outcome|Placebo|
1205682|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
1205683|NCT00282464|O2|Outcome|Placebo|
1205684|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
1205685|NCT00282464|O2|Outcome|Placebo|
1205686|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
1205687|NCT00282464|O2|Outcome|Placebo|
1205721|NCT00282438|P1|Participant Flow|Autologous Hematopoietic Stem Cell Transplantation|"Autologous stem cells will be injected after conditioning~Autologous hematopoietic stem cell transplantation: Autologous hematopoietic stem cells will be injected after conditioning"
1205688|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
1205689|NCT00282464|O2|Outcome|Placebo|
1205690|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
1205691|NCT00282464|O2|Outcome|Placebo|
1205692|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
1205693|NCT00282464|O2|Outcome|Placebo|
1205694|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
1205695|NCT00282464|O2|Outcome|Placebo|
1205696|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
1205697|NCT00282464|O2|Outcome|Placebo|
1205698|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
1205699|NCT00282464|O2|Outcome|Placebo|
1205700|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
1205701|NCT00282464|O2|Outcome|Placebo|
1205702|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
1205703|NCT00282464|O2|Outcome|Placebo|
1205704|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
1205705|NCT00282464|O2|Outcome|Placebo|
1205706|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
1205707|NCT00282464|O2|Outcome|Placebo|
1205708|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
1205709|NCT00282464|O2|Outcome|Placebo|
1205710|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
1205711|NCT00282464|O2|Outcome|Placebo|
1205712|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
1205713|NCT00282464|O2|Outcome|Placebo|
1205714|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
1205715|NCT00282464|E2|Reported Event|Placebo|
1205716|NCT00282464|E1|Reported Event|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
1205717|NCT00282438|B3|Baseline|Total|Total of all reporting groups
1205718|NCT00282438|B2|Baseline|Allogeneic Stem Cell Transplantation|"Allogeneic stem cells will be injected after conditioning~Allogeneic stem cell transplantation: Allogeneic stem cells will be injected after conditioning"
1205723|NCT00282438|O1|Outcome|Autologous Hematopoietic Stem Cell Transplantation|"Autologous stem cells will be injected after conditioning~Autologous hematopoietic stem cell transplantation: Autologous hematopoietic stem cells will be injected after conditioning"
1205724|NCT00282438|E2|Reported Event|Allogeneic Stem Cell Transplantation|"Allogeneic stem cells will be injected after conditioning~Allogeneic stem cell transplantation: Allogeneic stem cells will be injected after conditioning"
1205725|NCT00282438|E1|Reported Event|Autologous Hematopoietic Stem Cell Transplantation|"Autologous stem cells will be injected after conditioning~Autologous hematopoietic stem cell transplantation: Autologous hematopoietic stem cells will be injected after conditioning"
1205726|NCT00282347|B3|Baseline|Total|Total of all reporting groups
1205727|NCT00282347|B2|Baseline|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
1205728|NCT00282347|B1|Baseline|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
1205729|NCT00282347|P2|Participant Flow|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
1205730|NCT00282347|P1|Participant Flow|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
1205731|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
1205732|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
1205733|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
1205734|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
1205769|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
1205736|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
1205737|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
1205738|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
1205739|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
1205740|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
1205741|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
1205742|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
1205743|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
1205744|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
1205745|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
1205746|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
1205747|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
1205748|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
1205749|NCT00282347|E4|Reported Event|Placebo - B Cell Follow-up Period|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
1205750|NCT00282347|E3|Reported Event|Rituximab - B Cell Follow-up Period|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
1205751|NCT00282347|E2|Reported Event|Placebo - Treatment and Safety Follow-up Periods|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
1205752|NCT00282347|E1|Reported Event|Rituximab - Treatment and Safety Follow-up Periods|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
1205753|NCT00282334|B3|Baseline|Total|Total of all reporting groups
1205754|NCT00282334|B2|Baseline|Telemonitoring of Home Blood Press|
1205755|NCT00282334|B1|Baseline|Conventional Blood Pressure Monitoring|
1205756|NCT00282334|P2|Participant Flow|Conventional|Conventional blood pressure monitoring
1205757|NCT00282334|P1|Participant Flow|Telemonitoring|Telemonitoring of home blood pressure
1205758|NCT00282334|O2|Outcome|Telemonitoring of Home Blood Press|
1205759|NCT00282334|O1|Outcome|Conventional Blood Pressure Monitoring|
1205760|NCT00282334|E2|Reported Event|Telemonitoring of Home Blood Press|
1205761|NCT00282334|E1|Reported Event|Conventional Blood Pressure Monitoring|
1205762|NCT00282308|B3|Baseline|Total|Total of all reporting groups
1205763|NCT00282308|B2|Baseline|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
1205764|NCT00282308|B1|Baseline|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
1205765|NCT00282308|P3|Participant Flow|All Patients (Combined Groups A and B)|Patients who qualified for re-treatment received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/week orally or subcutaneously. Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab. Patients received no treatment during the Safety Follow-up Period.
1205766|NCT00282308|P2|Participant Flow|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
1205767|NCT00282308|P1|Participant Flow|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
1205768|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
1206629|NCT00280917|O4|Outcome|Placebo|Matching placebo q12 hours for 12 weeks
1205770|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
1205771|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
1205772|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
1205773|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
1205774|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
1205775|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
1205776|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
1205777|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
1205778|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
1205779|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
1205780|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
1205781|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
1205782|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
1205783|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
1205784|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
1205785|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
1205786|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
1205787|NCT00282308|E6|Reported Event|Group B - Safety Follow-up Period|Patients received no treatment during the Safety Follow-up Period.
1205788|NCT00282308|E5|Reported Event|Group A - Safety Follow-up Period|Patients received no treatment during the Safety Follow-up Period.
1205923|NCT00282113|P3|Participant Flow|Placebo|A dilute preparation of pregestimil formula (negligible caloric content)
1205789|NCT00282308|E4|Reported Event|Group B - Optional Extension Re-treatment Period|Patients who qualified for re-treatment received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/week orally or subcutaneously. Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab.
1205790|NCT00282308|E3|Reported Event|Group A - Optional Extension Re-treatment Period|Patients who qualified for re-treatment received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/week orally or subcutaneously. Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab.
1205791|NCT00282308|E2|Reported Event|Methotrexate (Group B) - Treatment Period|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
1205792|NCT00282308|E1|Reported Event|Rituximab + Methotrexate (Group A) - Treatment Period|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
1205793|NCT00282295|B4|Baseline|Total|Total of all reporting groups
1205794|NCT00282295|B3|Baseline|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205795|NCT00282295|B2|Baseline|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205796|NCT00282295|B1|Baseline|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
1205797|NCT00282295|P3|Participant Flow|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205798|NCT00282295|P2|Participant Flow|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205799|NCT00282295|P1|Participant Flow|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
1205800|NCT00282295|O3|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205956|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
1205801|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205802|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-admisistered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
1205803|NCT00282295|O3|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205804|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205805|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-admisistered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
1205806|NCT00282295|O3|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205807|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205808|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-admisistered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
1205809|NCT00282295|O3|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205810|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205811|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-admisistered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
1205812|NCT00282295|O1|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205813|NCT00282295|O3|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205924|NCT00282113|P2|Participant Flow|Culturelle|Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.
1205814|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205815|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-admisistered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
1205816|NCT00282295|O1|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205817|NCT00282295|O3|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205818|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205819|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
1205820|NCT00282295|O1|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205821|NCT00282295|O2|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205822|NCT00282295|O1|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205823|NCT00282295|O3|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205824|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1206630|NCT00280917|O3|Outcome|CF101 4 mg|CF101 4 mg q12 hours for 12 weeks
1205825|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-admisistered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
1205826|NCT00282295|O3|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205827|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205828|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
1205829|NCT00282295|O3|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205830|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205831|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
1205832|NCT00282295|O1|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205833|NCT00282295|O3|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205834|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205835|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
1205836|NCT00282295|O2|Outcome|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205837|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-admisistered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
1205925|NCT00282113|P1|Participant Flow|ProBioPlus|ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks
1205838|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205839|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
1205840|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205841|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
1205842|NCT00282295|O2|Outcome|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205843|NCT00282295|O1|Outcome|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
1205844|NCT00282295|E3|Reported Event|Menactra-Boostrix Group|Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205845|NCT00282295|E2|Reported Event|Boostrix-Menactra Group|Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
1205846|NCT00282295|E1|Reported Event|Boostrix + Menactra Group|Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-admisistered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.
1205912|NCT00282152|O1|Outcome|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
1205847|NCT00282282|B1|Baseline|Tacrolimus and Sirolimus|Participants received a tacrolimus and sirolimus graft-versus-host disease (GVHD) prophylaxis regimen. Tacrolimus was given 0.05 mg/kg/day (in 2 daily divided doses) orally starting 3 days before bone marrow transplant with a target serum concentration of 5-10ng/mL. Sirolimus was administered with a 12mg oral loading dose 3 days prior to transplantwith a target serum concentration of 3-12ng/mL. Tapering of tacrolimus and sirolimus doses was encouraged starting 64 days after transplant with a goal of discontinuing immunosuppression therapy approximately 6 months after transplant if there were no signs of GVHD.
1205848|NCT00282282|P1|Participant Flow|Tacrolimus and Sirolimus|Participants received a tacrolimus and sirolimus graft-versus-host disease (GVHD) prophylaxis regimen. Tacrolimus was given 0.05 mg/kg/day (in 2 daily divided doses) orally starting 3 days before bone marrow transplant with a target serum concentration of 5-10ng/mL. Sirolimus was administered with a 12mg oral loading dose 3 days prior to transplantwith a target serum concentration of 3-12ng/mL. Tapering of tacrolimus and sirolimus doses was encouraged starting 64 days after transplant with a goal of discontinuing immunosuppression therapy approximately 6 months after transplant if there were no signs of GVHD.
1205849|NCT00282282|O1|Outcome|Tacrolimus and Sirolimus GVHD Prophylaxis|
1205850|NCT00282282|O1|Outcome|Tacrolimus and Sirolimus|
1205851|NCT00282282|O1|Outcome|Tacrolimus and Sirolimus|
1205852|NCT00282282|E1|Reported Event|Tacrolimus and Sirolimus|Participants received a tacrolimus and sirolimus graft-versus-host disease (GVHD) prophylaxis regimen. Tacrolimus was given 0.05 mg/kg/day (in 2 daily divided doses) orally starting 3 days before bone marrow transplant with a target serum concentration of 5-10ng/mL. Sirolimus was administered with a 12mg oral loading dose 3 days prior to transplantwith a target serum concentration of 3-12ng/mL. Tapering of tacrolimus and sirolimus doses was encouraged starting 64 days after transplant with a goal of discontinuing immunosuppression therapy approximately 6 months after transplant if there were no signs of GVHD.
1205853|NCT00282256|B1|Baseline|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
1205854|NCT00282256|P1|Participant Flow|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
1205855|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
1205856|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
1205857|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
1205858|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
1205859|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
1205860|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
1205954|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
1205955|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
1205861|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
1205862|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
1205863|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
1205864|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
1205865|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
1205866|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
1205867|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
1205868|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
1205926|NCT00282113|O3|Outcome|Placebo|A dilute preparation of pregestimil formula (negligible caloric content)
1205869|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
1205870|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
1205871|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
1205872|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
1206631|NCT00280917|O2|Outcome|CF101 1 mg|CF101 1 mg q12 hours for 12 weeks
1205873|NCT00282256|E1|Reported Event|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
1205874|NCT00282243|B1|Baseline|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
1205875|NCT00282243|P1|Participant Flow|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
1205876|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
1205877|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
1205878|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
1205927|NCT00282113|O2|Outcome|Culturelle|Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.
1205928|NCT00282113|O1|Outcome|ProBioPlus|ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks
1205929|NCT00282113|O3|Outcome|Placebo|A dilute preparation of pregestimil formula (negligible caloric content)
1205879|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
1205880|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
1205881|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
1206103|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
1205882|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
1205883|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
1205884|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
1205885|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
1205886|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
1205887|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
1205930|NCT00282113|O2|Outcome|Culturelle|Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.
1205931|NCT00282113|O1|Outcome|ProBioPlus|ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks
1205932|NCT00282113|O3|Outcome|Placebo|A dilute preparation of pregestimil formula (negligible caloric content)
1205888|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
1205889|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
1205890|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
1205891|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
1205892|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
1205893|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
1205894|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
1205895|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
1205896|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
1205933|NCT00282113|O2|Outcome|Culturelle|Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.
1205934|NCT00282113|O1|Outcome|ProBioPlus|ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks
1205935|NCT00282113|E3|Reported Event|Placebo|A dilute preparation of pregestimil formula (negligible caloric content)
1205897|NCT00282243|E1|Reported Event|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
1205898|NCT00282152|B3|Baseline|Total|Total of all reporting groups
1205899|NCT00282152|B2|Baseline|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.~B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson’s disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs"
1205900|NCT00282152|B1|Baseline|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
1206104|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
1205901|NCT00282152|P2|Participant Flow|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.~B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson’s disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs"
1205902|NCT00282152|P1|Participant Flow|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
1205903|NCT00282152|O2|Outcome|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.~B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson’s disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary."
1205904|NCT00282152|O1|Outcome|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
1205905|NCT00282152|O2|Outcome|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.~B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson’s disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary."
1205906|NCT00282152|O1|Outcome|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
1205907|NCT00282152|O2|Outcome|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.~B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson’s disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary."
1205908|NCT00282152|O1|Outcome|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
1205909|NCT00282152|O2|Outcome|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.~B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson’s disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary."
1205910|NCT00282152|O1|Outcome|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
1205911|NCT00282152|O2|Outcome|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.~B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson’s disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary."
1205913|NCT00282152|O2|Outcome|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive B-STN DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.~B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for advanced PD. DBS is not approved for early stage PD. The STN is a part of the brain that is very small in size and is located in the middle of the right and left sides of the brain. In this disease, this part of the brain becomes overactive and causes the symptoms of PD. It is thought that using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs"
1205914|NCT00282152|O1|Outcome|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
1205915|NCT00282152|O2|Outcome|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive bilateral subthalamic nucleus (B-STN) DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.~B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for mid- and advanced PD. DBS is not approved for early stage PD. In mid- and advanced stage Parkinson’s disease, using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary."
1205916|NCT00282152|O1|Outcome|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
1205917|NCT00282152|E2|Reported Event|Deep Brain Stimulation (DBS) Plus Optimal Drug Therapy (ODT)|"Subjects receive B-STN DBS and continue to take optimal drug therapy as prescribed by their treating neurologist.~B-STN DBS: Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for advanced PD. DBS is not approved for early stage PD. The STN is a part of the brain that is very small in size and is located in the middle of the right and left sides of the brain. In this disease, this part of the brain becomes overactive and causes the symptoms of PD. It is thought that using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs"
1205918|NCT00282152|E1|Reported Event|Optimal Drug Therapy (ODT)|"Patients receive optimal drug therapy as prescribed by their treating neurologist.~Optimal drug therapy: The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline."
1205919|NCT00282113|B4|Baseline|Total|Total of all reporting groups
1205920|NCT00282113|B3|Baseline|Placebo|A dilute preparation of pregestimil formula (negligible caloric content)
1205921|NCT00282113|B2|Baseline|Culturelle|Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.
1205922|NCT00282113|B1|Baseline|ProBioPlus|ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks
1205936|NCT00282113|E2|Reported Event|Culturelle|Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.
1205937|NCT00282113|E1|Reported Event|ProBioPlus|ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks
1205938|NCT00282087|B1|Baseline|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
1205939|NCT00282087|P1|Participant Flow|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|Gemcitabine 900 mg/m2 on days 1 and 8 intravenously over 90 minutes, followed by Docetaxel 75 mg/m2 on day 8 intravenously over 1 hour.
1205940|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
1205941|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
1205942|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
1205943|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
1205944|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
1205945|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
1205946|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
1205947|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
1205948|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|Number of major toxicity events
1205949|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
1205950|NCT00282087|E1|Reported Event|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
1205951|NCT00282048|B1|Baseline|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
1205952|NCT00282048|P1|Participant Flow|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
1205953|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
1205957|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
1205958|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
1205959|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
1205960|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
1205961|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
1205962|NCT00282048|E1|Reported Event|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
1205963|NCT00281957|B3|Baseline|Total|Total of all reporting groups
1205964|NCT00281957|B2|Baseline|Arm II: Sorafenib + Tipifarnib|Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21
1205965|NCT00281957|B1|Baseline|Arm I: Sorafenib + Temsirolimus|Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
1205966|NCT00281957|P2|Participant Flow|Sorafenib + Tipifarnib|Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21
1205967|NCT00281957|P1|Participant Flow|Sorafenib + Temsirolimus|Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
1205968|NCT00281957|O2|Outcome|Sorafenib+Tipifarnib|Sorafenib and Tipifarnib
1205969|NCT00281957|O1|Outcome|Sorafenib+Temsirolimus|Sorafenib and Temsirolimus
1205970|NCT00281957|O2|Outcome|Sorafenib+Tipifarnib|Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21
1205971|NCT00281957|O1|Outcome|Sorafenib+Temsirolimus|Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
1205972|NCT00281957|O2|Outcome|Sorafenib+Tipifarnib|Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21
1205973|NCT00281957|O1|Outcome|Sorafenib+Temsirolimus|Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
1205974|NCT00281957|O2|Outcome|Sorafenib+Tipifarnib|Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21
1205975|NCT00281957|O1|Outcome|Sorafenib+Temsirolimus|Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
1205976|NCT00281957|E2|Reported Event|Arm II|Sorafenib and Tipifarnib
1205977|NCT00281957|E1|Reported Event|Arm I|Sorafenib and Temsirolimu
1205978|NCT00281918|B3|Baseline|Total|Total of all reporting groups
1205979|NCT00281918|B2|Baseline|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
1205980|NCT00281918|B1|Baseline|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
1205981|NCT00281918|P2|Participant Flow|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
1205982|NCT00281918|P1|Participant Flow|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
1205983|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
1205984|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
1205985|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
1205986|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
1205987|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
1205988|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
1206105|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
1206106|NCT00281632|O1|Outcome|Pazopanib 800 mg|: 800 milligrams (mg) pazopanib administered orally once daily
1205989|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
1205990|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
1205991|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
1205992|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
1205993|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
1205994|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
1205995|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
1205996|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
1205997|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
1205998|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
1205999|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
1206000|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
1206001|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
1206002|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
1206003|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
1206004|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
1206005|NCT00281918|E2|Reported Event|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
1206006|NCT00281918|E1|Reported Event|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
1206007|NCT00281879|B9|Baseline|Total|Total of all reporting groups
1206018|NCT00281879|P6|Participant Flow|ATG For Cord Blood Transplants|If you are undergoing a pre-transplant conditioning regimen prior to undergoing a cord blood transplant, you will receive a drug called ATG to improve your chances of engraftment and decrease your risk of graft versus host disease. You may receive ATG 3 times during your transplant regimen on days –3 through days –1 in addition to your pre-transplant conditioning therapy. Methylprednisolone will also be given during each dose of ATG to help reduce any reactions during infusion.
1206107|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
1206008|NCT00281879|B8|Baseline|Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)|On the day after your admission, you will start receiving radiation therapy (TBI). Radiation will be given to you 2 times a day for 3 days. On the next day, you will then begin your chemotherapy with a drug called etoposide. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm for one day. After the etoposide treatment, on the next day you will receive cyclophosphamide (also known as Cytoxan) for 2 days. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. This allows your body time to remove and inactivate the chemotherapy. After a day of rest, you will be given your donor’s cells.
1206009|NCT00281879|B7|Baseline|DLI (Donor Leukocyte Infusion)|Donor Leukocyte Infusions: You will receive DLI from your original transplant donor. This will be given through a vein , usually in your arm. It will be similar to getting a platelet or blood transfusion. You may require more than one DLI. The decision to give you another infusion will be determined by your condition, relapse status, GVHD and how much DLI you were given before. You may need chemotherapy and/or radiation to improve your disease status prior to additional DLI’s.
1206010|NCT00281879|B6|Baseline|ATG For Cord Blood Transplants|If you are undergoing a pre-transplant conditioning regimen prior to undergoing a cord blood transplant, you will receive a drug called ATG to improve your chances of engraftment and decrease your risk of graft versus host disease. You may receive ATG 3 times during your transplant regimen on days –3 through days –1 in addition to your pre-transplant conditioning therapy. Methylprednisolone will also be given during each dose of ATG to help reduce any reactions during infusion.
1206011|NCT00281879|B5|Baseline|Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only)|On the day of your admission you will start to take a drug called Dilantin which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. On the next day, you will then begin your conditioning therapy with a drug called busulfan. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm four times per day for four days. After the busulfan treatment, you will receive 4 doses each of two drugs, cyclophosphamide (also known as Cytoxan) and fludarabine, over 2 hours into your vein.
1206012|NCT00281879|B4|Baseline|Low-Dose Fludarabine and TBI(for Second Stem Cell Donation)|A conditioning regimen of low-dose fludarabine and TBI is used in the event that a second donation of hematopoietic stem cells is necessary. Chemotherapy with Fludarabine will begin 4 days prior to your transplant. This drug will be given through the catheter in your chest daily for 3 days. TBI (radiation) will be given to you on the day of your transplant. After your TBI, your donor's stem cells / bone marrow will be given to you through your catheter. The drugs cyclosporine and mycophenolate mofetil (MMF) will be given orally to help you accept your donor's cells.
1206013|NCT00281879|B3|Baseline|BEAM Regimen|On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosine arabinoside (ARA-C), and melphalan. This conditioning regimen is known as the BEAM regimen. The dose of this therapy is high enough to kill cancer cells but will also kill all of your normal blood forming cells. Subjects undergoing the BEAM regimen will not have total body irradiation (TBI).
1206014|NCT00281879|B2|Baseline|Busulfan and Cyclophosphamide (Cytoxan)|On admission day, you will start to take a drug called Dilantin, which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol,which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin the therapy with a drug called busulfan. This medicine is take by mouth four times per day for four days. After the oral busulfan treatment, you will receive two doses of cyclophosphamide over 2 hours by vein (through a small tube leading into the bloodstream). When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. Subjects undergoing the Busulfan and Cyclophosphamide regimen will not have total body irradiation (TBI).
1206085|NCT00281658|O2|Outcome|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
1206015|NCT00281879|B1|Baseline|Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI)|On admission day, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin radiation therapy to your entire body at the start of your transplant treatment. This procedure is called TBI (total body irradiation). Radiation will be given to you 2 times a day for 3 or 4 days. After the radiation treatment, you will receive two doses of cyclophosphamide by vein (through a small plastic tube leading into the bloodstream). Each dose takes about 2 hours to administer. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy.
1206016|NCT00281879|P8|Participant Flow|Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)|On the day after your admission, you will start receiving radiation therapy (TBI). Radiation will be given to you 2 times a day for 3 days. On the next day, you will then begin your chemotherapy with a drug called etoposide. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm for one day. After the etoposide treatment, on the next day you will receive cyclophosphamide (also known as Cytoxan) for 2 days. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. This allows your body time to remove and inactivate the chemotherapy. After a day of rest, you will be given your donor’s cells.
1206017|NCT00281879|P7|Participant Flow|DLI (Donor Leukocyte Infusion)|Donor Leukocyte Infusions: You will receive DLI from your original transplant donor. This will be given through a vein , usually in your arm. It will be similar to getting a platelet or blood transfusion. You may require more than one DLI. The decision to give you another infusion will be determined by your condition, relapse status, GVHD and how much DLI you were given before. You may need chemotherapy and/or radiation to improve your disease status prior to additional DLI’s.
1206019|NCT00281879|P5|Participant Flow|Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only)|On the day of your admission you will start to take a drug called Dilantin which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. On the next day, you will then begin your conditioning therapy with a drug called busulfan. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm four times per day for four days. After the busulfan treatment, you will receive 4 doses each of two drugs, cyclophosphamide (also known as Cytoxan) and fludarabine, over 2 hours into your vein.
1206020|NCT00281879|P4|Participant Flow|Low-Dose Fludarabine and TBI(for Second Stem Cell Donation)|A conditioning regimen of low-dose fludarabine and TBI is used in the event that a second donation of hematopoietic stem cells is necessary. Chemotherapy with Fludarabine will begin 4 days prior to your transplant. This drug will be given through the catheter in your chest daily for 3 days. TBI (radiation) will be given to you on the day of your transplant. After your TBI, your donor's stem cells / bone marrow will be given to you through your catheter. The drugs cyclosporine and mycophenolate mofetil (MMF) will be given orally to help you accept your donor's cells.
1206021|NCT00281879|P3|Participant Flow|BEAM Regimen|On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosine arabinoside (ARA-C), and melphalan. This conditioning regimen is known as the BEAM regimen. The dose of this therapy is high enough to kill cancer cells but will also kill all of your normal blood forming cells. Subjects undergoing the BEAM regimen will not have total body irradiation (TBI).
1206022|NCT00281879|P2|Participant Flow|Busulfan and Cyclophosphamide (Cytoxan)|On admission day, you will start to take a drug called Dilantin, which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol,which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin the therapy with a drug called busulfan. This medicine is take by mouth four times per day for four days. After the oral busulfan treatment, you will receive two doses of cyclophosphamide over 2 hours by vein (through a small tube leading into the bloodstream). When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. Subjects undergoing the Busulfan and Cyclophosphamide regimen will not have total body irradiation (TBI).
1206023|NCT00281879|P1|Participant Flow|Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI)|On admission day, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin radiation therapy to your entire body at the start of your transplant treatment. This procedure is called TBI (total body irradiation). Radiation will be given to you 2 times a day for 3 or 4 days. After the radiation treatment, you will receive two doses of cyclophosphamide by vein (through a small plastic tube leading into the bloodstream). Each dose takes about 2 hours to administer. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy.
1206036|NCT00281879|E4|Reported Event|Low-Dose Fludarabine and TBI(for Second Stem Cell Donation)|A conditioning regimen of low-dose fludarabine and TBI is used in the event that a second donation of hematopoietic stem cells is necessary. Chemotherapy with Fludarabine will begin 4 days prior to your transplant. This drug will be given through the catheter in your chest daily for 3 days. TBI (radiation) will be given to you on the day of your transplant. After your TBI, your donor's stem cells / bone marrow will be given to you through your catheter. The drugs cyclosporine and mycophenolate mofetil (MMF) will be given orally to help you accept your donor's cells.
1206024|NCT00281879|O8|Outcome|Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)|On the day after your admission, you will start receiving radiation therapy (TBI). Radiation will be given to you 2 times a day for 3 days. On the next day, you will then begin your chemotherapy with a drug called etoposide. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm for one day. After the etoposide treatment, on the next day you will receive cyclophosphamide (also known as Cytoxan) for 2 days. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. This allows your body time to remove and inactivate the chemotherapy. After a day of rest, you will be given your donor's cells.
1206025|NCT00281879|O7|Outcome|DLI (Donor Leukocyte Infusion)|Donor Leukocyte Infusions: You will receive DLI from your original transplant donor. This will be given through a vein , usually in your arm. It will be similar to getting a platelet or blood transfusion. You may require more than one DLI. The decision to give you another infusion will be determined by your condition, relapse status, GVHD and how much DLI you were given before. You may need chemotherapy and/or radiation to improve your disease status prior to additional DLI's.
1206026|NCT00281879|O6|Outcome|ATG For Cord Blood Transplants|If you are undergoing a pre-transplant conditioning regimen prior to undergoing a cord blood transplant, you will receive a drug called ATG to improve your chances of engraftment and decrease your risk of graft versus host disease. You may receive ATG 3 times during your transplant regimen on days -3 through days -1 in addition to your pre-transplant conditioning therapy. Methylprednisolone will also be given during each dose of ATG to help reduce any reactions during infusion.
1206027|NCT00281879|O5|Outcome|Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only)|On the day of your admission you will start to take a drug called Dilantin which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. On the next day, you will then begin your conditioning therapy with a drug called busulfan. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm four times per day for four days. After the busulfan treatment, you will receive 4 doses each of two drugs, cyclophosphamide (also known as Cytoxan) and fludarabine, over 2 hours into your vein.
1206100|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
1206028|NCT00281879|O4|Outcome|Low-Dose Fludarabine and TBI(for Second Stem Cell Donation)|A conditioning regimen of low-dose fludarabine and TBI is used in the event that a second donation of hematopoietic stem cells is necessary. Chemotherapy with Fludarabine will begin 4 days prior to your transplant. This drug will be given through the catheter in your chest daily for 3 days. TBI (radiation) will be given to you on the day of your transplant. After your TBI, your donor's stem cells / bone marrow will be given to you through your catheter. The drugs cyclosporine and mycophenolate mofetil (MMF) will be given orally to help you accept your donor's cells.
1206029|NCT00281879|O3|Outcome|BEAM Regimen|On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosine arabinoside (ARA-C), and melphalan. This conditioning regimen is known as the BEAM regimen. The dose of this therapy is high enough to kill cancer cells but will also kill all of your normal blood forming cells. Subjects undergoing the BEAM regimen will not have total body irradiation (TBI).
1206030|NCT00281879|O2|Outcome|Busulfan and Cyclophosphamide (Cytoxan)|
1206031|NCT00281879|O1|Outcome|Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI)|
1206032|NCT00281879|E8|Reported Event|Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)|On the day after your admission, you will start receiving radiation therapy (TBI). Radiation will be given to you 2 times a day for 3 days. On the next day, you will then begin your chemotherapy with a drug called etoposide. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm for one day. After the etoposide treatment, on the next day you will receive cyclophosphamide (also known as Cytoxan) for 2 days. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. This allows your body time to remove and inactivate the chemotherapy. After a day of rest, you will be given your donor’s cells.
1206033|NCT00281879|E7|Reported Event|DLI (Donor Leukocyte Infusion)|Donor Leukocyte Infusions: You will receive DLI from your original transplant donor. This will be given through a vein , usually in your arm. It will be similar to getting a platelet or blood transfusion. You may require more than one DLI. The decision to give you another infusion will be determined by your condition, relapse status, GVHD and how much DLI you were given before. You may need chemotherapy and/or radiation to improve your disease status prior to additional DLI’s.
1206034|NCT00281879|E6|Reported Event|ATG For Cord Blood Transplants|If you are undergoing a pre-transplant conditioning regimen prior to undergoing a cord blood transplant, you will receive a drug called ATG to improve your chances of engraftment and decrease your risk of graft versus host disease. You may receive ATG 3 times during your transplant regimen on days –3 through days –1 in addition to your pre-transplant conditioning therapy. Methylprednisolone will also be given during each dose of ATG to help reduce any reactions during infusion.
1206035|NCT00281879|E5|Reported Event|Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only)|On the day of your admission you will start to take a drug called Dilantin which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. On the next day, you will then begin your conditioning therapy with a drug called busulfan. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm four times per day for four days. After the busulfan treatment, you will receive 4 doses each of two drugs, cyclophosphamide (also known as Cytoxan) and fludarabine, over 2 hours into your vein.
1206054|NCT00281697|B3|Baseline|Total|Total of all reporting groups
1206055|NCT00281697|B2|Baseline|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
1206136|NCT00281580|B1|Baseline|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
1206037|NCT00281879|E3|Reported Event|BEAM Regimen|On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosine arabinoside (ARA-C), and melphalan. This conditioning regimen is known as the BEAM regimen. The dose of this therapy is high enough to kill cancer cells but will also kill all of your normal blood forming cells. Subjects undergoing the BEAM regimen will not have total body irradiation (TBI).
1206038|NCT00281879|E2|Reported Event|Busulfan and Cyclophosphamide (Cytoxan)|On admission day, you will start to take a drug called Dilantin, which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol,which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin the therapy with a drug called busulfan. This medicine is take by mouth four times per day for four days. After the oral busulfan treatment, you will receive two doses of cyclophosphamide over 2 hours by vein (through a small tube leading into the bloodstream). When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. Subjects undergoing the Busulfan and Cyclophosphamide regimen will not have total body irradiation (TBI).
1206039|NCT00281879|E1|Reported Event|Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI)|On admission day, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin radiation therapy to your entire body at the start of your transplant treatment. This procedure is called TBI (total body irradiation). Radiation will be given to you 2 times a day for 3 or 4 days. After the radiation treatment, you will receive two doses of cyclophosphamide by vein (through a small plastic tube leading into the bloodstream). Each dose takes about 2 hours to administer. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy.
1206101|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
1206102|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
1206040|NCT00281840|B1|Baseline|Bevacizumab With Docetaxel and Radiation Therapy|Radiation therapy will be delivered using standard once-daily fractionation, five days a week for 8 weeks. Bevacizumab is administered intravenously once on day 1 every two weeks during the course of radiation and up to one year following completion of radiation therapy, at which point bevacizumab will be discontinued.Patients meeting planned neck dissection criteria, will not receive bevacizumab therapy following completion of concurrent chemo-radiation therapy (for at least 8 weeks prior to surgery). Bevacizumab therapy will restart 4 weeks after planned neck dissection for nine months.Docetaxel is administered intravenously once per week only during the course of radiation.
1206041|NCT00281840|P1|Participant Flow|Bevacizumab With Docetaxel and Radiation Therapy|Radiation therapy will be delivered using standard once-daily fractionation, five days a week for 8 weeks. Bevacizumab is administered intravenously once on day 1 every two weeks during the course of radiation and up to one year following completion of radiation therapy, at which point bevacizumab will be discontinued.Patients meeting planned neck dissection criteria, will not receive bevacizumab therapy following completion of concurrent chemo-radiation therapy (for at least 8 weeks prior to surgery). Bevacizumab therapy will restart 4 weeks after planned neck dissection for nine months.Docetaxel is administered intravenously once per week only during the course of radiation.
1206042|NCT00281840|O1|Outcome|Bevacizumab With Docetaxel and Radiation Therapy|"bevacizumab: Bevacizumab IV over 30-90 minutes once every 2 weeks for up to 1 year. Bevacizumab, which stops 8 weeks before surgery, may restart 4 weeks after surgery and continue for 9 months in the absence of disease progression or unacceptable toxicity.~docetaxel: docetaxel IV over 1 hour once a week for 8 weeks~conventional surgery: 8-10 weeks after the completion of chemoradiotherapy, patients may undergo neck dissection~radiation therapy: radiotherapy once daily, 5 days a week, for 8 weeks"
1206043|NCT00281840|O1|Outcome|Bevacizumab With Docetaxel and Radiation Therapy|Radiation therapy will be delivered using standard once-daily fractionation, five days a week for 8 weeks. Bevacizumab is administered intravenously once on day 1 every two weeks during the course of radiation and up to one year following completion of radiation therapy, at which point bevacizumab will be discontinued.Patients meeting planned neck dissection criteria, will not receive bevacizumab therapy following completion of concurrent chemo-radiation therapy (for at least 8 weeks prior to surgery). Bevacizumab therapy will restart 4 weeks after planned neck dissection for nine months.Docetaxel is administered intravenously once per week only during the course of radiation.
1206044|NCT00281840|E1|Reported Event|Bevacizumab With Docetaxel and Radiation Therapy|Radiation therapy will be delivered using standard once-daily fractionation, five days a week for 8 weeks. Bevacizumab is administered intravenously once on day 1 every two weeks during the course of radiation and up to one year following completion of radiation therapy, at which point bevacizumab will be discontinued.Patients meeting planned neck dissection criteria, will not receive bevacizumab therapy following completion of concurrent chemo-radiation therapy (for at least 8 weeks prior to surgery). Bevacizumab therapy will restart 4 weeks after planned neck dissection for nine months.Docetaxel is administered intravenously once per week only during the course of radiation.
1206045|NCT00281827|B1|Baseline|Intent-to-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
1206046|NCT00281827|P1|Participant Flow|Intent-to-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
1206047|NCT00281827|O1|Outcome|Intent-to-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
1206048|NCT00281827|O1|Outcome|Intent-to-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
1206049|NCT00281827|O1|Outcome|Intent-to-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
1206050|NCT00281827|O1|Outcome|Intent-To-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
1206051|NCT00281827|O1|Outcome|Intent-to-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
1206052|NCT00281827|O1|Outcome|Evaluable Patients|Patients receiving 3 complete cycles of treatment (all 3 drugs over 3 - 21 day time periods).
1206053|NCT00281827|E1|Reported Event|Intent-to-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
1206056|NCT00281697|B1|Baseline|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
1206057|NCT00281697|P2|Participant Flow|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
1206058|NCT00281697|P1|Participant Flow|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
1206059|NCT00281697|O2|Outcome|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
1206060|NCT00281697|O1|Outcome|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
1206061|NCT00281697|O2|Outcome|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
1206062|NCT00281697|O1|Outcome|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
1206063|NCT00281697|O2|Outcome|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
1206064|NCT00281697|O1|Outcome|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
1206065|NCT00281697|O2|Outcome|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
1206066|NCT00281697|O1|Outcome|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
1206067|NCT00281697|O2|Outcome|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
1206068|NCT00281697|O1|Outcome|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
1206069|NCT00281697|O2|Outcome|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
1206070|NCT00281697|O1|Outcome|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
1206071|NCT00281697|E2|Reported Event|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
1206072|NCT00281697|E1|Reported Event|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
1206073|NCT00281658|B3|Baseline|Total|Total of all reporting groups
1206074|NCT00281658|B2|Baseline|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
1206075|NCT00281658|B1|Baseline|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
1206076|NCT00281658|P3|Participant Flow|Lapatinib 1500 mg|Lapatinib 1500 mg administered once daily
1206077|NCT00281658|P2|Participant Flow|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
1206078|NCT00281658|P1|Participant Flow|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
1206079|NCT00281658|O2|Outcome|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
1206080|NCT00281658|O1|Outcome|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
1206081|NCT00281658|O2|Outcome|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
1206082|NCT00281658|O1|Outcome|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
1206083|NCT00281658|O2|Outcome|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
1206084|NCT00281658|O1|Outcome|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
1206086|NCT00281658|O1|Outcome|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
1206087|NCT00281658|O2|Outcome|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
1206088|NCT00281658|O1|Outcome|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
1206089|NCT00281658|O2|Outcome|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
1206090|NCT00281658|O1|Outcome|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
1206091|NCT00281658|E3|Reported Event|Lapatinib 1500 mg|Lapatinib 1500 mg administered once daily. This is not a comparative treatment arm.
1206092|NCT00281658|E2|Reported Event|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
1206093|NCT00281658|E1|Reported Event|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
1206094|NCT00281632|B1|Baseline|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
1206095|NCT00281632|P1|Participant Flow|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
1206096|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
1206097|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
1206098|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
1206099|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
1206108|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
1206109|NCT00281632|O3|Outcome|Pazopanib 800 mg All|800 milligrams (mg) pazopanib administered orally once daily All participants
1206110|NCT00281632|O2|Outcome|Pazopanib 800 mg Non-Responders|800 milligrams (mg) pazopanib administered orally once daily Non-Responders
1206111|NCT00281632|O1|Outcome|Pazopanib 800 mg Responders|800 milligrams (mg) pazopanib administered orally once daily Responders
1206112|NCT00281632|O3|Outcome|Pazopanib 800 mg All|All participants administered 800 milligrams (mg) pazopanib administered orally once daily
1206113|NCT00281632|O2|Outcome|Pazopanib 800 mg Without Measurable Disease|Participants without measureable disease at baseline who were administered 800 milligrams (mg) pazopanib administered orally once daily.
1206114|NCT00281632|O1|Outcome|Pazopanib 800 mg With Measurable Disease|Participants with measureable disease at baseline who were administered 800 milligrams (mg) pazopanib administered orally once daily
1206115|NCT00281632|O1|Outcome|Overall Study Arm|
1206116|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
1206117|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
1206118|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
1206119|NCT00281632|E1|Reported Event|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
1206120|NCT00281580|B17|Baseline|Total|Total of all reporting groups
1206121|NCT00281580|B16|Baseline|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
1206122|NCT00281580|B15|Baseline|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
1206123|NCT00281580|B14|Baseline|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
1206124|NCT00281580|B13|Baseline|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206125|NCT00281580|B12|Baseline|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206126|NCT00281580|B11|Baseline|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
1206127|NCT00281580|B10|Baseline|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
1206128|NCT00281580|B9|Baseline|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206129|NCT00281580|B8|Baseline|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
1206130|NCT00281580|B7|Baseline|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206131|NCT00281580|B6|Baseline|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
1206132|NCT00281580|B5|Baseline|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
1206133|NCT00281580|B4|Baseline|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
1206134|NCT00281580|B3|Baseline|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
1206135|NCT00281580|B2|Baseline|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
1206137|NCT00281580|P16|Participant Flow|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
1206138|NCT00281580|P15|Participant Flow|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
1206139|NCT00281580|P14|Participant Flow|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
1206140|NCT00281580|P13|Participant Flow|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206141|NCT00281580|P12|Participant Flow|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206142|NCT00281580|P11|Participant Flow|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
1206143|NCT00281580|P10|Participant Flow|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
1206144|NCT00281580|P9|Participant Flow|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206145|NCT00281580|P8|Participant Flow|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
1206146|NCT00281580|P7|Participant Flow|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206147|NCT00281580|P6|Participant Flow|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
1206148|NCT00281580|P5|Participant Flow|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
1206149|NCT00281580|P4|Participant Flow|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
1206150|NCT00281580|P3|Participant Flow|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
1206151|NCT00281580|P2|Participant Flow|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
1206152|NCT00281580|P1|Participant Flow|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
1206153|NCT00281580|O4|Outcome|Combination Therapy|Telmisartan 20/40/80mg tablet plus 2.5/5 mg capsule or 2 x 5mg capsules, QD in morning
1206154|NCT00281580|O3|Outcome|Amlodipine Monotherapy|encapsulated Amlodipine 2.5/5 mg capsule or 2 x 5mg capsules, QD in morning
1206155|NCT00281580|O2|Outcome|Telmisartan Monotherapy|Telmisartan 20/40/80mg tablet, QD in morning
1206156|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
1206157|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206158|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206159|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206160|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206161|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206162|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206163|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206164|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206165|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206166|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206167|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206168|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206169|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206170|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206171|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
1206172|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206173|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206174|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206175|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206176|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206177|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206178|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206179|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206180|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206181|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206182|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206183|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206184|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206185|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206186|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206187|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
1206188|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206189|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206190|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206191|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206192|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206193|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206194|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206195|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
1206196|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206197|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206198|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206199|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
1206200|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206201|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
1206202|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
1206203|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
1206204|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206205|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206206|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
1206207|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
1206208|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206209|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
1206210|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206211|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
1206212|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
1206213|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
1206214|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
1206215|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
1206216|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
1206217|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206218|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206219|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206220|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206221|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
1206222|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
1206223|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
1206224|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206225|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206226|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
1206227|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206228|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206229|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
1206230|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206231|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
1206232|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
1206233|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
1206234|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
1206235|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
1206236|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
1206237|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
1206238|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
1207589|NCT00275834|O3|Outcome|Zonisamide 400 mg|
1206239|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
1206240|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206241|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206242|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
1206243|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
1206244|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206245|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
1206246|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206247|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
1206248|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
1206249|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
1206250|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
1206251|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
1206252|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
1206253|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206254|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206255|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
1206256|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206257|NCT00281580|O15|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
1206258|NCT00281580|O14|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
1206259|NCT00281580|O13|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
1206260|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206261|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206262|NCT00281580|O10|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
1206263|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
1206264|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206265|NCT00281580|O7|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
1206266|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206267|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
1206268|NCT00281580|O4|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
1206269|NCT00281580|O3|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
1206270|NCT00281580|O2|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
1206271|NCT00281580|O1|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
1206272|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
1206273|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
1206274|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
1206275|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206276|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206277|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
1206278|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
1206279|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206280|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
1206281|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206282|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
1206283|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
1206284|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
1206285|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
1206286|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
1206287|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
1206288|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
1206289|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
1206290|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
1206291|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1238279|NCT00126581|O1|Outcome|Mutant|
1206292|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206293|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
1206294|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
1206295|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206296|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
1206297|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206298|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
1206299|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
1206300|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
1206301|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
1206302|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
1206303|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
1206304|NCT00281580|O4|Outcome|Amlodipine 10 mg (A10) - Overall|Overall: including all treatment groups involving A10
1206305|NCT00281580|O3|Outcome|Amlodipine 5 mg (A5) - Overall|Overall: including all treatment groups involving A5
1206306|NCT00281580|O2|Outcome|Amlodipine 2.5 mg (A2.5) - Overall|Overall: including all treatment groups involving A2.5
1206307|NCT00281580|O1|Outcome|Amlodipine 0 mg (A0) - Overall|Overall: including Pl, T20, T40, and T80 treatment groups
1206308|NCT00281580|O4|Outcome|Amlodipine 10 mg (A10) - Overall|Overall: including all treatment groups involving A10
1206309|NCT00281580|O3|Outcome|Amlodipine 5 mg (A5) - Overall|Overall: including all treatment groups involving A5
1206310|NCT00281580|O2|Outcome|Amlodipine 2.5 mg (A2.5) - Overall|Overall: including all treatment groups involving A2.5
1206311|NCT00281580|O1|Outcome|Amlodipine 0 mg (A0) - Overall|Overall: including Pl, T20, T40, and T80 treatment groups
1206312|NCT00281580|O4|Outcome|Amlodipine 10 mg (A10)|monotherapy (A5 titrated to A10)
1206313|NCT00281580|O3|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
1206314|NCT00281580|O2|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
1206315|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
1206316|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Overall: including all treatment groups involving T80
1206317|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Overall: including all treatment groups involving T40
1206318|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Overall: including all treatment groups involving T20
1206319|NCT00281580|O1|Outcome|Telmisartan 0 mg (T0)|Overall: including Pl, A2.5, A5, and A10 treated groups
1206320|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206321|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206322|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
1206323|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206324|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206325|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206326|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
1206327|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206328|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206329|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206330|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
1206331|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206332|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206333|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206334|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
1206335|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206336|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206337|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206338|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
1206339|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206340|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206341|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206342|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
1206343|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206599|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
1206344|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206345|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206346|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
1206347|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206348|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206349|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206350|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
1206351|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206352|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206353|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206354|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
1206355|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206356|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206357|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206358|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
1206359|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206360|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206361|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206362|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
1206363|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206364|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206365|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206366|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
1206367|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206368|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
1206369|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
1206370|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
1206371|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206372|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206373|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
1206374|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
1206375|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206376|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
1206377|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206378|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
1206379|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
1206380|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
1206381|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
1206382|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
1206383|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
1206384|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
1206385|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
1206386|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
1206387|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206388|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206389|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
1206390|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
1206391|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206392|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
1206393|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206394|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
1206395|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
1206396|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
1206397|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
1206398|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
1206399|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
1206400|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
1206401|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
1206402|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
1206403|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206404|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206405|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
1206406|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
1206407|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206408|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
1206409|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206410|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
1206411|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
1206412|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
1206413|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
1206414|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
1206415|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
1206416|NCT00281580|O15|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
1206417|NCT00281580|O14|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
1206418|NCT00281580|O13|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
1206419|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206565|NCT00281320|O1|Outcome|Asenapine 5mg BID Day 4|Pharmacokinetic parameter of asepanine for Day 4.
1206420|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206421|NCT00281580|O10|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
1206422|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
1206423|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206424|NCT00281580|O7|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
1206425|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206426|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
1206427|NCT00281580|O4|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
1206428|NCT00281580|O3|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
1206429|NCT00281580|O2|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
1206430|NCT00281580|O1|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
1206431|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
1206432|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
1206433|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
1206434|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206435|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206436|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
1206437|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
1206438|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206439|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
1206440|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206441|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
1206442|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
1206443|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
1206444|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
1206445|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
1206446|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
1206447|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
1206448|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
1238280|NCT00126581|O2|Outcome|Wild Type|
1206449|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
1206450|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206451|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
1206452|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
1206453|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
1206454|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
1206455|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
1206456|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
1206457|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
1206458|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
1206459|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
1206460|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
1206461|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
1206462|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
1206463|NCT00281580|O4|Outcome|Amlodipine 10 mg (A10)|monotherapy (A5 titrated to A10)
1206464|NCT00281580|O3|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
1206465|NCT00281580|O2|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
1206466|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
1206467|NCT00281580|O4|Outcome|Amlodipine 10 mg (A10)|monotherapy (A5 titrated to A10)
1206468|NCT00281580|O3|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
1206469|NCT00281580|O2|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
1206470|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
1206471|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Overall: including all treatment groups involving T80
1206472|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Overall: including all treatment groups involving T40
1206473|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Overall: including all treatment groups involving T20
1206474|NCT00281580|O1|Outcome|Telmisartan 0 mg (T0)|Overall: including Pl, A2.5, A5, and A10 treated groups
1206475|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Overall: including all treatment groups involving T80
1206476|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Overall: including all treatment groups involving T40
1206477|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Overall: including all treatment groups involving T20
1206478|NCT00281580|O1|Outcome|Telmisartan 0 mg (T0)|Overall: including Pl, A2.5, A5, and A10 treated groups
1206479|NCT00281580|E16|Reported Event|Amlodipine 10 mg (A10)|
1206480|NCT00281580|E15|Reported Event|Amlodipine 5 mg (A5)|
1206481|NCT00281580|E14|Reported Event|Amlodipine 2.5 mg (A2.5)|
1206482|NCT00281580|E13|Reported Event|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|
1206483|NCT00281580|E12|Reported Event|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|
1206484|NCT00281580|E11|Reported Event|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|
1206485|NCT00281580|E10|Reported Event|Telmisartan 80 mg (T80)|
1206486|NCT00281580|E9|Reported Event|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|
1206487|NCT00281580|E8|Reported Event|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|
1206488|NCT00281580|E7|Reported Event|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|
1206489|NCT00281580|E6|Reported Event|Telmisartan 40 mg (T40)|
1206490|NCT00281580|E5|Reported Event|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|
1206491|NCT00281580|E4|Reported Event|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|
1206492|NCT00281580|E3|Reported Event|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|
1206493|NCT00281580|E2|Reported Event|Telmisartan 20 mg (T20)|
1206494|NCT00281580|E1|Reported Event|PLACEBO|
1206495|NCT00281528|B4|Baseline|Total|Total of all reporting groups
1206496|NCT00281528|B3|Baseline|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
1206497|NCT00281528|B2|Baseline|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
1206498|NCT00281528|B1|Baseline|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
1206499|NCT00281528|P3|Participant Flow|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
1206500|NCT00281528|P2|Participant Flow|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
1206501|NCT00281528|P1|Participant Flow|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
1206502|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
1206503|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
1206504|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
1206505|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
1206506|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
1206507|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
1238281|NCT00126581|O1|Outcome|Mutant|
1206508|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
1206509|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
1206510|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
1206511|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
1206512|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
1206513|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
1206514|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
1206515|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
1206516|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
1206517|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
1206518|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
1206519|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
1206520|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
1206521|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
1206522|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
1206523|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
1206524|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
1206525|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
1206526|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
1206527|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
1206528|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
1206529|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
1206530|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
1206531|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
1206532|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
1206533|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
1206534|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
1206535|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
1206536|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
1206537|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
1206538|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
1206539|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
1206540|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
1206541|NCT00281528|E3|Reported Event|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
1206542|NCT00281528|E2|Reported Event|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
1206543|NCT00281528|E1|Reported Event|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
1206544|NCT00281463|B1|Baseline|Pushrim Activated Power Assist Wheelchair|"Participants will be asked to propel both their own chair and a pushrim activated power assist wheelchair on a computer controlled wheelchair dynamometer.~Pushrim Activated Power Assist: The PAPAW is an electrically-powered add-on unit for common manual wheelchairs. The unit automatically supplements the users manual pushrim input with additional rear-wheel torque for up to six kilometers/hour traveling velocity. The amount of added torque is provided proportional to the user input to the pushrims. Movement and braking assistance is provided for both forward and rearward travel. Several types and sizes are available based on users operating strength, needs and anthropometry. The PAPAWs to be tested during this study will be the JWII (Yamaha Motor Corporation)."
1206545|NCT00281463|P1|Participant Flow|Pushrim Activated Power Assist Wheelchair|"Participants will be asked to propel both their own chair and a pushrim activated power assist wheelchair on a computer controlled wheelchair dynamometer.~Pushrim Activated Power Assist: The PAPAW is an electrically-powered add-on unit for common manual wheelchairs. The unit automatically supplements the users manual pushrim input with additional rear-wheel torque for up to six kilometers/hour traveling velocity. The amount of added torque is provided proportional to the user input to the pushrims. Movement and braking assistance is provided for both forward and rearward travel. Several types and sizes are available based on users operating strength, needs and anthropometry. The PAPAWs to be tested during this study will be the JWII (Yamaha Motor Corporation)."
1206546|NCT00281463|O1|Outcome|Pushrim Activated Power Assist Wheelchair|Participants were asked to propel both their own chair and a pushrim activated power assist wheelchair on a computer controlled wheelchair dynamometer.
1206600|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
1250836|NCT00091273|O1|Outcome|Single Arm|
1206547|NCT00281463|O1|Outcome|Pushrim Activated Power Assist Wheelchair|Participants were asked to propel both their own chair and a pushrim activated power assist wheelchair on a computer controlled wheelchair dynamometer.
1206548|NCT00281463|E1|Reported Event|Pushrim Activated Power Assist Wheelchair|"Participants were asked to propel both their own chair and a pushrim activated power assist wheelchair on a computer controlled wheelchair dynamometer.~Pushrim Activated Power Assist: The PAPAW is an electrically-powered add-on unit for common manual wheelchairs. The unit automatically supplements the users manual pushrim input with additional rear-wheel torque for up to six kilometers/hour traveling velocity. The amount of added torque is provided proportional to the user input to the pushrims. Movement and braking assistance is provided for both forward and rearward travel. Several types and sizes are available based on users operating strength, needs and anthropometry. The PAPAWs to be tested during this study will be the JWII (Yamaha Motor Corporation)."
1206549|NCT00281320|B3|Baseline|Total|Total of all reporting groups
1206550|NCT00281320|B2|Baseline|Asenapine 5-10 mg BID|Asenapine 5 mg twice daily (BID) on Days 1 to 4 followed by 10 mg BID on Day 5 through the end of the trial (Week 6)
1206551|NCT00281320|B1|Baseline|Asenapine 2-10 mg BID|Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Day 5 through the end of the trial (Week 6)
1206552|NCT00281320|P2|Participant Flow|Asenapine 5-10 mg BID|Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Day 5 through the end of the trial (Week 6)
1206553|NCT00281320|P1|Participant Flow|Asenapine 2-10 mg Twice Daily (BID)|Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Day 5 through the end of the trial (Week 6)
1206554|NCT00281320|O2|Outcome|Asenapine 10mg BID Day 8|Pharmacokinetic parameter of asenapine for Day 8.
1206555|NCT00281320|O1|Outcome|Asenapine 5mg BID Day 4|Pharmacokinetic parameter of asenapine for Day 4.
1206556|NCT00281320|O2|Outcome|Asenapine 10mg BID Day 8|Pharmacokinetic parameter of asenapine for Day 8.
1206557|NCT00281320|O1|Outcome|Asenapine 5mg BID Day 4|Pharmacokinetic parameter of asenapine for Day 4.
1206558|NCT00281320|O2|Outcome|Asenapine 10mg BID Day 8|Pharmacokinetic parameters of asepanine for Day 8.
1206559|NCT00281320|O1|Outcome|Asenapine 5mg BID Day 4|Pharmacokinetic parameters of asepanine for Day 4.
1206560|NCT00281320|O2|Outcome|Asenapine 10mg BID Day 8|Pharmacokinetic parameter of asepanine for Day 8.
1206561|NCT00281320|O1|Outcome|Asenapine 5mg BID Day 4|Pharmacokinetic parameter of asepanine for Day 4.
1206562|NCT00281320|O2|Outcome|Asenapine 10mg BID Day 8|Pharmacokinetic parameter of asepanine for Day 8.
1206563|NCT00281320|O1|Outcome|Asenapine 5mg BID Day 4|Pharmacokinetic parameter of asepanine for Day 4.
1206564|NCT00281320|O2|Outcome|Asenapine 10mg BID Day 8|Pharmacokinetic parameter of asepanine for Day 8.
1206566|NCT00281320|O2|Outcome|Asenapine 5-10 mg BID|Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Days 5 through the end of the trial (Week 6)
1206567|NCT00281320|O1|Outcome|Asenapine 2-10 mg Twice Daily (BID)|Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Days 5 through the end of the trial (Week 6)
1206568|NCT00281320|O2|Outcome|Asenapine 5-10 mg BID|Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Days 5 through the end of the trial (Week 6)
1206569|NCT00281320|O1|Outcome|Asenapine 2-10 mg Twice Daily (BID)|Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Days 5 through the end of the trial (Week 6)
1206570|NCT00281320|E2|Reported Event|Asenapine 5-10mg BID|
1206571|NCT00281320|E1|Reported Event|Asenapine 2-10mg BID|
1206572|NCT00281099|B3|Baseline|Total|Total of all reporting groups
1206573|NCT00281099|B2|Baseline|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
1206574|NCT00281099|B1|Baseline|VVI 40 Pacing|Backup ventricular pacing at a rate of 40 beats per minute
1206575|NCT00281099|P2|Participant Flow|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
1206576|NCT00281099|P1|Participant Flow|VVI 40 Pacing|Backup ventricular pacing at a rate of 40 beats per minute
1206577|NCT00281099|O1|Outcome|All Screened Patients|All Patients Screened for Possible Enrollment
1206578|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
1206579|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
1206580|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
1206581|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
1206582|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
1206583|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
1206584|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
1206585|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
1206586|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
1206587|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
1206588|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
1206589|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
1206590|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
1206591|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
1206592|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
1206593|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
1206594|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
1206595|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
1206596|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
1206597|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
1206598|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
1206601|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
1206602|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
1206603|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
1206604|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
1206605|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
1206606|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
1206607|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
1206608|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
1206609|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
1206610|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
1206611|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
1206612|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
1206613|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
1206614|NCT00281099|E2|Reported Event|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
1206615|NCT00281099|E1|Reported Event|VVI 40 Pacing|Backup ventricular pacing at a rate of 40 beats per minute
1206616|NCT00281021|B1|Baseline|Erlotinib and Digoxin|"Erlotinib plus Digoxin~Erlotinib plus Digoxin : Each subject will receive erlotinib and digoxin daily until progression."
1206617|NCT00281021|P1|Participant Flow|Erlotinib and Digoxin|"Erlotinib plus Digoxin~Erlotinib plus Digoxin : Each subject will receive erlotinib and digoxin daily until progression."
1206618|NCT00281021|O1|Outcome|Erlotinib and Digoxin|"Erlotinib plus Digoxin~Erlotinib plus Digoxin : Each subject will receive erlotinib and digoxin daily until progression."
1206619|NCT00281021|E1|Reported Event|Erlotinib and Digoxin|"Erlotinib plus Digoxin~Erlotinib plus Digoxin : Each subject will receive erlotinib and digoxin daily until progression."
1206620|NCT00280917|B5|Baseline|Total|Total of all reporting groups
1206621|NCT00280917|B4|Baseline|Placebo|Matching Placebo q12 hours for 12 weeks
1206622|NCT00280917|B3|Baseline|CF101 4mg|CF101 4 mg q12 hours for 12 weeks
1206623|NCT00280917|B2|Baseline|CF101 1mg|CF101 1 mg q12 hours for 12 weeks
1206624|NCT00280917|B1|Baseline|CF101 0.1mg|CF101 0.1 mg q12 hours for 12 weeks
1206625|NCT00280917|P4|Participant Flow|Placebo|Matching placebo q12 hours orally
1206626|NCT00280917|P3|Participant Flow|CF101 4mg|CF101 4mg q12 hours orally
1206627|NCT00280917|P2|Participant Flow|CF101 1mg|CF101 1mg q12 hours orally
1206632|NCT00280917|O1|Outcome|CF101 0.1 mg|CF101 0.1 mg q12 hours for 12 weeks
1206633|NCT00280917|E4|Reported Event|Placebo|Matching placebo
1206634|NCT00280917|E3|Reported Event|CF101 4mg|CF101 4 mg given orally q12h for 12 weeks
1206635|NCT00280917|E2|Reported Event|CF101 1mg|CF101 1 mg given orally q12h for 12 weeks
1206636|NCT00280917|E1|Reported Event|CF101 0.1mg|CF101 0.1 mg given orally q12h for 12 weeks
1206637|NCT00280904|B1|Baseline|Ventriculoperitoneal Shunt Patients|Patients receiving a de novo standard or antibiotic (AI) catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.
1206638|NCT00280904|P1|Participant Flow|Ventriculoperitoneal Shunt Patients|Patients receiving a de novo standard or antibiotic (AI) catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.
1206639|NCT00280904|O1|Outcome|Ventriculoperitoneal Shunt Patients|Patients receiving a de novo antibiotic impregnated (AI) or standard catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.
1206640|NCT00280904|O1|Outcome|Ventriculoperitoneal Shunt Patients|Patients receiving a de novo antibiotic impregnated(AI)or standard catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.
1206641|NCT00280904|E1|Reported Event|Ventriculoperitoneal Shunt Patients|Patients receiving a de novo standard or antibiotic (AI) catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.
1206642|NCT00280826|B1|Baseline|Efalizumab|Treatment of cystoid macular edema due to uveitis
1206643|NCT00280826|P1|Participant Flow|Efalizumab|Treatment of cystoid macular edema due to uveitis
1206644|NCT00280826|O1|Outcome|Efalizumab|Treatment of cystoid macular edema due to uveitis
1206645|NCT00280826|O1|Outcome|Efalizumab|Treatment of cystoid macular edema due to uveitis
1206646|NCT00280826|O1|Outcome|Efalizumab|Treatment of cystoid macular edema due to uveitis
1206647|NCT00280826|O1|Outcome|Efalizumab|Treatment of cystoid macular edema due to uveitis
1206648|NCT00280826|O1|Outcome|Efalizumab|Treatment of cystoid macular edema due to uveitis
1206649|NCT00280826|E1|Reported Event|Efalizumab|Treatment of cystoid macular edema due to uveitis
1206650|NCT00280735|B1|Baseline|Single Arm Trial|"adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles~carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)~docetaxel: 75 mg/m² intravenously, once, every 3 weeks"
1206651|NCT00280735|P1|Participant Flow|Single Arm Trial|"adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles~carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)~docetaxel: 75 mg/m² intravenously, once, every 3 weeks"
1206690|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
1206691|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
1250837|NCT00091273|O1|Outcome|Single Arm|
1206652|NCT00280735|O1|Outcome|Single Arm Trial|"adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles~carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)~docetaxel: 75 mg/m² intravenously, once, every 3 weeks"
1206653|NCT00280735|O1|Outcome|Single Arm Trial|"adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles~carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)~docetaxel: 75 mg/m² intravenously, once, every 3 weeks"
1206654|NCT00280735|O3|Outcome|Grade 3/4 %|Percentage of patients receiving treatment who developed this toxicity
1206655|NCT00280735|O2|Outcome|Grade 4 %|Percentage of patients receiving treatment who developed this toxicity
1206656|NCT00280735|O1|Outcome|Grade 3 %|Percentage of patients receiving treatment who developed this toxicity
1206657|NCT00280735|O1|Outcome|Single Arm Trial|Patients who relapsed
1206658|NCT00280735|O1|Outcome|Single Arm Trial|"adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles~carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)~docetaxel: 75 mg/m² intravenously, once, every 3 weeks"
1206659|NCT00280735|E1|Reported Event|Single Arm Trial|"adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles~carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)~docetaxel: 75 mg/m² intravenously, once, every 3 weeks"
1206660|NCT00280683|B3|Baseline|Total|Total of all reporting groups
1206661|NCT00280683|B2|Baseline|Placebo|Placebo intervention
1206662|NCT00280683|B1|Baseline|Arginine|2.3. L-Arginine Intervention The randomization process and disbursement of L-arginine (0.05 g/kg twice daily; 6-10 g/day) and placebo were done by the UC Davis Investigational Drug Service to ensure that both the physician and participant were blinded. The subjects began the study medication on day 0 and continued for 90 days and were asked to discontinue use of any nutritional supplements prior to the start of the study.
1206663|NCT00280683|P2|Participant Flow|Placebo|2.3. L-Arginine Intervention The randomization process and disbursement of L-arginine and placebo were done by the UC Davis Investigational Drug Service to ensure that both the physician and participant were blinded.
1206664|NCT00280683|P1|Participant Flow|Arginine|2.3. L-Arginine Intervention The randomization process and disbursement of L-arginine and placebo were done by the UC Davis Investigational Drug Service to ensure that both the physician and participant were blinded.
1206665|NCT00280683|O2|Outcome|Placebo|Matching placebo tablets were disbursed by the Investigational Drug Service.
1206666|NCT00280683|O1|Outcome|Arginine|L-Arginine Intervention The randomization process and disbursement of L-arginine (0.05 g/kg twice daily; 6-10 g/day) and placebo were done by the UC Davis Investigational Drug Service to ensure that both the physician and participant were blinded. The subjects began the study medication on day 0 and continued for 90 days and were asked to discontinue use of any nutritional supplements prior to the start of the study.
1206667|NCT00280683|O2|Outcome|Placebo|Matching placebo tablets were made by Jarrow Formulas.
1206668|NCT00280683|O1|Outcome|Arginine|The L-arginine 1g tablets were from Jarrow formulas (Los Angeles, CA). The name of these tablets is Arginine 1000.
1206669|NCT00280683|E2|Reported Event|Placebo|Matching placebo tablets were purchased from Jarrow Formulas.
1206670|NCT00280683|E1|Reported Event|Arginine|L-arginine 1 g tablets were made by Jarrow Formulas.
1206671|NCT00280566|B3|Baseline|Total|Total of all reporting groups
1206672|NCT00280566|B2|Baseline|Placebo|Double-blind,randomized to placebo plus mood stabilizer. Subjects were tapered off ziprasidone onto placebo by decreasing 20 mg BID every 2 days during the first week of Period 2
1206673|NCT00280566|B1|Baseline|Ziprasidone|Double-blind, randomized ziprasidone at the dose level received during the last 4 weeks of Open Label Period.
1206674|NCT00280566|P3|Participant Flow|Placebo|Double-blind,randomized to placebo plus mood stabilizer. Subjects were tapered off ziprasidone onto placebo by decreasing 20 mg BID every 2 days during the first week of Period 2
1206675|NCT00280566|P2|Participant Flow|Ziprasidone|Double-blind, randomized ziprasidone at the dose level received during the last 4 weeks of Open Label Period.
1206676|NCT00280566|P1|Participant Flow|Period 1 Open Label Ziprasidone|40 - 80 milligram (mg) ziprasidone twice/day (BID) plus mood stabilizer. Dose adjusted on basis of toleration and efficacy.
1206677|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
1206678|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
1206679|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
1206680|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
1206681|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
1206682|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
1206683|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
1206684|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
1206685|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
1206686|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
1206687|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
1206688|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
1206689|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
1207590|NCT00275834|O2|Outcome|Zonisamide 200 mg|
1206692|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
1206693|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
1206694|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
1206695|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
1206696|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
1206697|NCT00280566|E3|Reported Event|Placebo|Double-blind,randomized to placebo plus mood stabilizer. Subjects were tapered off ziprasidone onto placebo by decreasing 20 mg BID every 2 days during the first week of Period 2
1206698|NCT00280566|E2|Reported Event|Ziprasidone|Double-blind, randomized ziprasidone at the dose level received during the last 4 weeks of Open Label Period.
1206699|NCT00280566|E1|Reported Event|Period 1 Open Label Ziprasidone|40 - 80 milligram (mg) ziprasidone twice/day (BID) plus mood stabilizer. Dose adjusted on basis of toleration and efficacy.
1206700|NCT00280397|B1|Baseline|E7080 Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
1206701|NCT00280397|P1|Participant Flow|E7080 Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
1206702|NCT00280397|O2|Outcome|E7080 - 20 mg Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
1206703|NCT00280397|O1|Outcome|E7080 - 16 mg Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
1206704|NCT00280397|O1|Outcome|E7080 Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
1206705|NCT00280397|O1|Outcome|E7080 Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
1206706|NCT00280397|E1|Reported Event|E7080 Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
1206707|NCT00280384|B9|Baseline|Total|Total of all reporting groups
1206708|NCT00280384|B8|Baseline|E2014 (Botulinum Toxin Type B) 500 U - Caucasian|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
1206709|NCT00280384|B7|Baseline|E2014 (Botulinum Toxin Type B) 100 U - Caucasian|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
1206710|NCT00280384|B6|Baseline|E2014 (Botulinum Toxin Type B) 20 U - Caucasian|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
1206711|NCT00280384|B5|Baseline|E2014 (Botulinum Toxin Type B) Placebo - Caucasian|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
1206712|NCT00280384|B4|Baseline|E2014 (Botulinum Toxin Type B) 500 U - Japanese|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
1206713|NCT00280384|B3|Baseline|E2014 (Botulinum Toxin Type B) 100 U - Japanese|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
1206714|NCT00280384|B2|Baseline|E2014 (Botulinum Toxin Type B) 20 U - Japanese|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
1206715|NCT00280384|B1|Baseline|E2014 (Botulinum Toxin Type B) Placebo- Japanese|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
1206716|NCT00280384|P8|Participant Flow|E2014 (Botulinum Toxin Type B) 500 U - Caucasian|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
1206717|NCT00280384|P7|Participant Flow|E2014 (Botulinum Toxin Type B) 100 U - Caucasian|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
1206718|NCT00280384|P6|Participant Flow|E2014 (Botulinum Toxin Type B) 20 U - Caucasian|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
1206719|NCT00280384|P5|Participant Flow|E2014 (Botulinum Toxin Type B) Placebo - Caucasian|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
1206720|NCT00280384|P4|Participant Flow|E2014 (Botulinum Toxin Type B) 500 U - Japanese|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
1206721|NCT00280384|P3|Participant Flow|E2014 (Botulinum Toxin Type B) 100 U - Japanese|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
1206722|NCT00280384|P2|Participant Flow|E2014 (Botulinum Toxin Type B) 20 U - Japanese|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
1206723|NCT00280384|P1|Participant Flow|E2014 (Botulinum Toxin Type B) Placebo- Japanese|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
1206884|NCT00279591|B2|Baseline|Intervention Group|Near Continuous Blood Pressure Monitoring
1206885|NCT00279591|B1|Baseline|Control Group|Oscillometric Blood Pressure Monitoring
1206724|NCT00280384|O8|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Caucasian|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
1206725|NCT00280384|O7|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Caucasian|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
1206726|NCT00280384|O6|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Caucasian|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
1206727|NCT00280384|O5|Outcome|E2014 (Botulinum Toxin Type B) Placebo - Caucasian|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
1206728|NCT00280384|O4|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Japanese|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
1206729|NCT00280384|O3|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Japanese|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
1206730|NCT00280384|O2|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Japanese|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
1206731|NCT00280384|O1|Outcome|E2014 (Botulinum Toxin Type B) Placebo- Japanese|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
1206732|NCT00280384|O8|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Caucasian|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
1206733|NCT00280384|O7|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Caucasian|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
1206734|NCT00280384|O6|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Caucasian|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
1206735|NCT00280384|O5|Outcome|E2014 (Botulinum Toxin Type B) Placebo - Caucasian|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
1206736|NCT00280384|O4|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Japanese|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
1206737|NCT00280384|O3|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Japanese|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
1206738|NCT00280384|O2|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Japanese|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
1206739|NCT00280384|O1|Outcome|E2014 (Botulinum Toxin Type B) Placebo- Japanese|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
1206740|NCT00280384|O8|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Caucasian|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
1206741|NCT00280384|O7|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Caucasian|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
1206742|NCT00280384|O6|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Caucasian|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
1206743|NCT00280384|O5|Outcome|E2014 (Botulinum Toxin Type B) Placebo - Caucasian|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
1206744|NCT00280384|O4|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Japanese|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
1206745|NCT00280384|O3|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Japanese|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
1206746|NCT00280384|O2|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Japanese|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
1206747|NCT00280384|O1|Outcome|E2014 (Botulinum Toxin Type B) Placebo- Japanese|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
1206748|NCT00280384|O8|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Caucasian|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
1206749|NCT00280384|O7|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Caucasian|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
1206750|NCT00280384|O6|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Caucasian|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
1206751|NCT00280384|O5|Outcome|E2014 (Botulinum Toxin Type B) Placebo - Caucasian|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
1206752|NCT00280384|O4|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Japanese|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
1206753|NCT00280384|O3|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Japanese|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
1206754|NCT00280384|O2|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Japanese|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
1206755|NCT00280384|O1|Outcome|E2014 (Botulinum Toxin Type B) Placebo- Japanese|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
1206756|NCT00280384|E8|Reported Event|E2014 (Botulinum Toxin Type B) 500 U - Caucasian|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
1206757|NCT00280384|E7|Reported Event|E2014 (Botulinum Toxin Type B) 100 U - Caucasian|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
1206758|NCT00280384|E6|Reported Event|E2014 (Botulinum Toxin Type B) 20 U - Caucasian|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
1206759|NCT00280384|E5|Reported Event|E2014 (Botulinum Toxin Type B) Placebo - Caucasian|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
1206760|NCT00280384|E4|Reported Event|E2014 (Botulinum Toxin Type B) 500 U - Japanese|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
1206761|NCT00280384|E3|Reported Event|E2014 (Botulinum Toxin Type B) 100 U - Japanese|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
1206762|NCT00280384|E2|Reported Event|E2014 (Botulinum Toxin Type B) 20 U - Japanese|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
1206763|NCT00280384|E1|Reported Event|E2014 (Botulinum Toxin Type B) Placebo- Japanese|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
1206764|NCT00280293|B3|Baseline|Total|Total of all reporting groups
1206765|NCT00280293|B2|Baseline|Placebo|Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
1206766|NCT00280293|B1|Baseline|Lamotrigine|Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
1206767|NCT00280293|P2|Participant Flow|Placebo|Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
1206768|NCT00280293|P1|Participant Flow|Lamotrigine|Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
1206769|NCT00280293|O2|Outcome|Placebo|Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
1206770|NCT00280293|O1|Outcome|Lamotrigine|Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
1206771|NCT00280293|O2|Outcome|Placebo|Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
1206772|NCT00280293|O1|Outcome|Lamotrigine|Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
1206773|NCT00280293|O2|Outcome|Placebo|Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
1206774|NCT00280293|O1|Outcome|Lamotrigine|Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
1206775|NCT00280293|O2|Outcome|Placebo|Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
1206776|NCT00280293|O1|Outcome|Lamotrigine|Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
1206777|NCT00280293|E2|Reported Event|Placebo|Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
1206778|NCT00280293|E1|Reported Event|Lamotrigine|Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
1206779|NCT00280241|B1|Baseline|FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB|"Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.~Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.~Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated."
1206780|NCT00280241|P1|Participant Flow|FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB|"Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.~Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.~Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated."
1206781|NCT00280241|O1|Outcome|FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB|"Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.~Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.~Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated."
1206782|NCT00280241|O1|Outcome|FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB|"Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.~Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.~Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated."
1206783|NCT00280241|O1|Outcome|FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB|"Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.~Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.~Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated."
1206784|NCT00280241|O1|Outcome|FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB|"Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.~Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.~Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated."
1206785|NCT00280241|E1|Reported Event|FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB|"Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.~Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.~Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated."
1206786|NCT00280059|B3|Baseline|Total|Total of all reporting groups
1206787|NCT00280059|B2|Baseline|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206788|NCT00280059|B1|Baseline|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206789|NCT00280059|P2|Participant Flow|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206790|NCT00280059|P1|Participant Flow|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206791|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206792|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206793|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1207591|NCT00275834|O1|Outcome|Placebo|
1206794|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206795|NCT00280059|O8|Outcome|Lamotrigine 500 mg/Day|Lamotrigine 500 mg/day administered BID
1206796|NCT00280059|O7|Outcome|Lamotrigine 400 mg/Day|Lamotrigine 400 mg/day administered BID
1206797|NCT00280059|O6|Outcome|Lamotrigine 200 mg/Day|Lamotrigine 200 mg/day administered BID
1206798|NCT00280059|O5|Outcome|Lamotrigine 100 mg/Day|Lamotrigine 100 mg/day administered BID
1206799|NCT00280059|O4|Outcome|Pregabalin 600 mg/Day|Pregabalin 600 mg/day administered BID
1206800|NCT00280059|O3|Outcome|Pregabalin 450 mg/Day|Pregabalin 450 mg/day administered BID
1206801|NCT00280059|O2|Outcome|Pregabalin 300 mg/Day|Pregabalin 300 mg/day administered BID
1206802|NCT00280059|O1|Outcome|Pregabalin 150 mg/Day|Pregabalin 150 mg/day administered twice daily (BID)
1206803|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206804|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206805|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206806|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206848|NCT00279955|E3|Reported Event|No OptiVol Measurement|All subjects either who were not followed for at least 6 months, or didn't have OptiVol Fluid Index measurements available.
1206807|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206808|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206809|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206810|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206811|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206812|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206813|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206814|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206815|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206816|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206817|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206818|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1207592|NCT00275834|O3|Outcome|Zonisamide 400 mg|
1206819|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206820|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206821|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206822|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206823|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206824|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206825|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206909|NCT00279214|B3|Baseline|Total|Total of all reporting groups
1207130|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
1206826|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206827|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206828|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206829|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206830|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206831|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206832|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206833|NCT00280059|E2|Reported Event|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206834|NCT00280059|E1|Reported Event|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
1206835|NCT00279955|B4|Baseline|Total|Total of all reporting groups
1206836|NCT00279955|B3|Baseline|No OptiVol Measurement|All subjects either who were not followed for at least 6 months, or didn't have OptiVol Fluid Index measurements available.
1206837|NCT00279955|B2|Baseline|No OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
1206838|NCT00279955|B1|Baseline|At Least 1 OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
1206839|NCT00279955|P3|Participant Flow|No OptiVol Measurement|All subjects either who were not followed for at least 6 months, or didn't have OptiVol Fluid Index measurements available.
1206886|NCT00279591|P2|Participant Flow|Intervention Group|Near Continuous Blood Pressure Monitoring
1206887|NCT00279591|P1|Participant Flow|Control Group|Oscillometric Blood Pressure Monitoring
1206840|NCT00279955|P2|Participant Flow|No OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
1206841|NCT00279955|P1|Participant Flow|At Least 1 OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
1206842|NCT00279955|O2|Outcome|No OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
1206843|NCT00279955|O1|Outcome|At Least 1 OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
1206844|NCT00279955|O2|Outcome|No OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
1206845|NCT00279955|O1|Outcome|At Least 1 OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
1206846|NCT00279955|O2|Outcome|No OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
1206847|NCT00279955|O1|Outcome|At Least 1 OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
1206849|NCT00279955|E2|Reported Event|No OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
1206850|NCT00279955|E1|Reported Event|At Least 1 OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
1206851|NCT00279916|B3|Baseline|Total|Total of all reporting groups
1206852|NCT00279916|B2|Baseline|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
1206853|NCT00279916|B1|Baseline|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
1206854|NCT00279916|P2|Participant Flow|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
1206855|NCT00279916|P1|Participant Flow|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
1206856|NCT00279916|O2|Outcome|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
1206857|NCT00279916|O1|Outcome|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
1206858|NCT00279916|O2|Outcome|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
1206859|NCT00279916|O1|Outcome|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
1206860|NCT00279916|O2|Outcome|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
1206861|NCT00279916|O1|Outcome|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
1250838|NCT00091273|O1|Outcome|Single Arm|
1206862|NCT00279916|O2|Outcome|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
1206863|NCT00279916|O1|Outcome|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
1206864|NCT00279916|O2|Outcome|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
1206865|NCT00279916|O1|Outcome|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
1206866|NCT00279916|O2|Outcome|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
1206867|NCT00279916|O1|Outcome|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
1206868|NCT00279916|O2|Outcome|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
1206910|NCT00279214|B2|Baseline|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
1207011|NCT00279201|O2|Outcome|Insulin Glargine Participants Who Did Not Maintain Goal|
1206869|NCT00279916|O1|Outcome|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
1206870|NCT00279916|O2|Outcome|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
1206871|NCT00279916|O1|Outcome|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
1206872|NCT00279916|E2|Reported Event|Placebo|"Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration."
1206873|NCT00279916|E1|Reported Event|Triamcinolone Acetonide|"Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.~Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration."
1206874|NCT00279708|B3|Baseline|Total|Total of all reporting groups
1206875|NCT00279708|B2|Baseline|Control Group (Placebo)|Placebo: In a double-blind fashion, subjects were assigned to receive the sham intervention which appeared the same as the intervention agent. For subjects meeting pre-specified criteria, a 50% dose reduction was applied during the 12 month treatment phase of the study.
1206876|NCT00279708|B1|Baseline|Intervention Group (Atorvastatin)|Atorvastatin: Subjects were assigned to the treatment intervention by way of double blind masking. Atorvastatin 80 mg/day was the initial treatment given, as tolerated for a 12 month period. During the study, a 50% dose reduction was applied for subjects meeting pre-specified criteria.
1206877|NCT00279708|P2|Participant Flow|Control Group (Placebo)|Placebo In a double-blind fashion, subjects were assigned to receive the sham intervention which appeared the same as the intervention agent. For subjects meeting pre-specified criteria, a 50% dose reduction was applied during the 12 month treatment phase of the study.
1206878|NCT00279708|P1|Participant Flow|Intervention Group (Atorvastatin)|Atorvastatin Subjects were assigned to the treatment intervention by way of double blind masking. Atorvastatin 80 mg/day was the initial treatment given, as tolerated for a 12 month period. During the study, a 50% dose reduction was applied for subjects meeting pre-specified criteria.
1206879|NCT00279708|O2|Outcome|Control Group (Placebo)|Placebo: In a double-blind fashion, subjects were assigned to receive the sham intervention which appeared the same as the intervention agent. For subjects meeting pre-specified criteria, a 50% dose reduction was applied during the 12 month treatment phase of the study: Placebo vs. Atorvastatin
1206880|NCT00279708|O1|Outcome|Intervention Group (Atorvastatin)|Atorvastatin: Subjects were assigned to the treatment intervention by way of double blind masking. Atorvastatin 80 mg/day was the initial treatment given, as tolerated for a 12 month period. During the study, a 50% dose reduction was applied for subjects meeting pre-specified criteria.
1206881|NCT00279708|E2|Reported Event|Control Group (Placebo)|Placebo: In a double-blind fashion, subjects were assigned to receive the sham intervention which appeared the same as the intervention agent. For subjects meeting pre-specified criteria, a 50% dose reduction was applied during the 12 month treatment phase of the study.
1206882|NCT00279708|E1|Reported Event|Intervention Group (Atorvastatin)|Atorvastatin: Subjects were assigned to the treatment intervention by way of double blind masking. Atorvastatin 80 mg/day was the initial treatment given, as tolerated for a 12 month period. During the study, a 50% dose reduction was applied for subjects meeting pre-specified criteria.
1206883|NCT00279591|B3|Baseline|Total|Total of all reporting groups
1206888|NCT00279591|O2|Outcome|Intervention Group|Near Continuous Blood Pressure Monitoring
1206889|NCT00279591|O1|Outcome|Control Group|Oscillometric Blood Pressure Monitoring
1206890|NCT00279591|O2|Outcome|Control Group|
1206891|NCT00279591|O1|Outcome|Intervention Group|
1206892|NCT00279591|O2|Outcome|Control Group|
1206893|NCT00279591|O1|Outcome|Intervention Group|
1206894|NCT00279591|O2|Outcome|Intervention Group|Near Continuous Blood Pressure Monitoring
1206895|NCT00279591|O1|Outcome|Control Group|Oscillometric Blood Pressure Monitoring
1206896|NCT00279591|O2|Outcome|Intervention Group|Near Continuous Blood Pressure Monitoring
1206897|NCT00279591|O1|Outcome|Control Group|Oscillometric Blood Pressure Monitoring
1206898|NCT00279591|E2|Reported Event|Intervention Group|Near Continuous Blood Pressure Monitoring
1206899|NCT00279591|E1|Reported Event|Control Group|Oscillometric Blood Pressure Monitoring
1206900|NCT00279305|B3|Baseline|Total|Total of all reporting groups
1206901|NCT00279305|B2|Baseline|Placebo|Placebo infusions were given to participants in control group on days 1, 8, 15, and 22.
1206902|NCT00279305|B1|Baseline|Rituximab Treatment|Four intravenous infusions (375 mg per square meter of body-surface area) were given on days 1, 8, 15, and 22 of the study
1206903|NCT00279305|P2|Participant Flow|Placebo|Placebo infusions were given to participants in control group on days 1, 8, 15, and 22.
1206904|NCT00279305|P1|Participant Flow|Rituximab Treatment|Four intravenous infusions (375 mg per square meter of body-surface area) were given on days 1, 8, 15, and 22 of the study
1206905|NCT00279305|O2|Outcome|Placebo|Placebo infusions were given to participants in control group on days 1, 8, 15, and 22.
1206906|NCT00279305|O1|Outcome|Rituximab Treatment|Four intravenous infusions (375 mg per square meter of body-surface area) were given on days 1, 8, 15, and 22 of the study
1206907|NCT00279305|E2|Reported Event|Placebo|Placebo infusions were given to participants in control group on days 1, 8, 15, and 22.
1206908|NCT00279305|E1|Reported Event|Rituximab Treatment|Four intravenous infusions (375 mg per square meter of body-surface area) were given on days 1, 8, 15, and 22 of the study
1206911|NCT00279214|B1|Baseline|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
1206912|NCT00279214|P2|Participant Flow|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
1206913|NCT00279214|P1|Participant Flow|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
1206914|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
1206915|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
1206916|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
1206917|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
1206918|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
1206919|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
1206920|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
1206921|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
1206922|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
1206923|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
1206924|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
1206925|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
1206926|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
1206927|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
1206928|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
1206929|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
1206930|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
1206931|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
1206932|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
1206933|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
1206934|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
1206935|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
1206936|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
1206937|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
1206938|NCT00279214|E2|Reported Event|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
1206939|NCT00279214|E1|Reported Event|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
1206940|NCT00279201|B3|Baseline|Total|Total of all reporting groups
1206941|NCT00279201|B2|Baseline|Lispro LM|Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
1207100|NCT00278954|P1|Participant Flow|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
1206942|NCT00279201|B1|Baseline|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
1206943|NCT00279201|P6|Participant Flow|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
1206944|NCT00279201|P5|Participant Flow|Basal Bolus Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
1206945|NCT00279201|P4|Participant Flow|Lispro Low Mix Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
1206946|NCT00279201|P3|Participant Flow|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
1206947|NCT00279201|P2|Participant Flow|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
1206948|NCT00279201|P1|Participant Flow|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
1206949|NCT00279201|O4|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
1206950|NCT00279201|O3|Outcome|Basal Bolus Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
1241310|NCT00117338|O2|Outcome|Placebo|
1206951|NCT00279201|O2|Outcome|Lispro LM Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
1206952|NCT00279201|O1|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
1206953|NCT00279201|O4|Outcome|Lispro Low Mix Prior Glargine Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
1206954|NCT00279201|O3|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
1206955|NCT00279201|O2|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
1206956|NCT00279201|O1|Outcome|Basal Bolus Prior Lispro LM Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
1206957|NCT00279201|O4|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
1206958|NCT00279201|O3|Outcome|Basal Bolus Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
1206959|NCT00279201|O2|Outcome|Lispro LM Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
1206960|NCT00279201|O1|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
1206961|NCT00279201|O4|Outcome|Lispro Low Mix Prior Glargine Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
1206962|NCT00279201|O3|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
1206963|NCT00279201|O2|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
1206964|NCT00279201|O1|Outcome|Basal Bolus Prior Lispro LM Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
1207323|NCT00276861|P1|Participant Flow|Oxaliplatin + Gemcitabine|
1206965|NCT00279201|O4|Outcome|Lispro Low Mix Prior Glargine Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
1206966|NCT00279201|O3|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
1206967|NCT00279201|O2|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
1206968|NCT00279201|O1|Outcome|Basal Bolus Prior Lispro LM Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
1206969|NCT00279201|O4|Outcome|Lispro Low Mix Prior Glargine Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
1206970|NCT00279201|O3|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
1206971|NCT00279201|O2|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
1206972|NCT00279201|O1|Outcome|Basal Bolus Prior Lispro LM Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
1207010|NCT00279201|O1|Outcome|Lispro LM Participants Who Maintained Goal|
1206973|NCT00279201|O4|Outcome|Lispro Low Mix Prior Glargine Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
1206974|NCT00279201|O3|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
1206975|NCT00279201|O2|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
1206976|NCT00279201|O1|Outcome|Basal Bolus Prior Lispro LM Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
1206977|NCT00279201|O4|Outcome|Lispro Low Mix Prior Glargine Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
1206978|NCT00279201|O3|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
1206979|NCT00279201|O2|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
1206980|NCT00279201|O1|Outcome|Basal Bolus Prior Lispro LM Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
1206981|NCT00279201|O4|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
1206982|NCT00279201|O3|Outcome|Basal Bolus Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
1206983|NCT00279201|O2|Outcome|Lispro LM Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
1206984|NCT00279201|O1|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
1206985|NCT00279201|O4|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
1206986|NCT00279201|O3|Outcome|Basal Bolus Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
1207324|NCT00276861|O1|Outcome|Oxaliplatin + Gemcitabine|
1206987|NCT00279201|O2|Outcome|Lispro LM Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
1206988|NCT00279201|O1|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
1206989|NCT00279201|O2|Outcome|Lispro LM Participants Who Did Not Maintain Goal|
1206990|NCT00279201|O1|Outcome|Lispro LM Participants Who Maintained Goal|
1206991|NCT00279201|O2|Outcome|Insulin Glargine Participants Who Did Not Maintain Goal|
1206992|NCT00279201|O1|Outcome|Insulin Glargine Participants Who Maintained Goal|
1206993|NCT00279201|O2|Outcome|Lispro LM Participants Who Did Not Maintain Goal|
1206994|NCT00279201|O1|Outcome|Lispro LM Participants Who Maintained Goal|
1206995|NCT00279201|O2|Outcome|Insulin Glargine Participants Who Did Not Maintain Goal|
1206996|NCT00279201|O1|Outcome|Insulin Glargine Participants Who Maintained Goal|
1206997|NCT00279201|O2|Outcome|Lispro LM Participants Who Did Not Maintain Goal|
1206998|NCT00279201|O1|Outcome|Lispro LM Participants Who Maintained Goal|
1206999|NCT00279201|O2|Outcome|Insulin Glargine Participants Who Did Not Maintain Goal|
1207000|NCT00279201|O1|Outcome|Insulin Glargine Participants Who Maintained Goal|
1207001|NCT00279201|O2|Outcome|Lispro LM Participants Who Did Not Maintain Goal|
1207002|NCT00279201|O1|Outcome|Lispro LM Participants Who Maintained Goal|
1207003|NCT00279201|O2|Outcome|Insulin Glargine Participants Who Did Not Maintain Goal|
1207004|NCT00279201|O1|Outcome|Insulin Glargine Participants Who Maintained Goal|
1207005|NCT00279201|O2|Outcome|Lispro LM Participants Who Did Not Maintain Goal|
1207006|NCT00279201|O1|Outcome|Lispro LM Participants Who Maintained Goal|
1207007|NCT00279201|O2|Outcome|Insulin Glargine Participants Who Did Not Maintain Goal|
1207008|NCT00279201|O1|Outcome|Insulin Glargine Participants Who Maintained Goal|
1207009|NCT00279201|O2|Outcome|Lispro LM Participants Who Did Not Maintain Goal|
1207012|NCT00279201|O1|Outcome|Insulin Glargine Participants Who Maintained Goal|
1207013|NCT00279201|O2|Outcome|Lispro LM Participants Who Did Not Maintain Goal|
1207014|NCT00279201|O1|Outcome|Lispro LM Participants Who Maintained Goal|
1207015|NCT00279201|O2|Outcome|Insulin Glargine Participants Who Did Not Maintain Goal|
1207016|NCT00279201|O1|Outcome|Insulin Glargine Participants Who Maintained Goal|
1207017|NCT00279201|O2|Outcome|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
1207018|NCT00279201|O1|Outcome|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
1207019|NCT00279201|O2|Outcome|Lispro Low Mix|Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
1207020|NCT00279201|O1|Outcome|Insulin Glargine|Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
1207021|NCT00279201|O2|Outcome|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
1207022|NCT00279201|O1|Outcome|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
1207023|NCT00279201|O2|Outcome|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
1207024|NCT00279201|O1|Outcome|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
1207025|NCT00279201|O2|Outcome|Lispro Low Mix|Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
1207026|NCT00279201|O1|Outcome|Insulin Glargine|Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
1207027|NCT00279201|O2|Outcome|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
1207028|NCT00279201|O1|Outcome|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
1207029|NCT00279201|O2|Outcome|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
1207030|NCT00279201|O1|Outcome|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
1207031|NCT00279201|O2|Outcome|Lispro Low Mix|Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
1207032|NCT00279201|O1|Outcome|Insulin Glargine|Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
1207033|NCT00279201|O2|Outcome|Lispro Low Mix|Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
1207034|NCT00279201|O1|Outcome|Insulin Glargine|Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
1207035|NCT00279201|O2|Outcome|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
1207325|NCT00276861|O1|Outcome|Single Arm|
1207036|NCT00279201|O1|Outcome|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks Maintenance: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
1207037|NCT00279201|O2|Outcome|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
1207038|NCT00279201|O1|Outcome|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
1207039|NCT00279201|O2|Outcome|Did Not Meet Goal|
1207040|NCT00279201|O1|Outcome|Met Goal|
1207041|NCT00279201|O2|Outcome|Did Not Meet Goal|
1207042|NCT00279201|O1|Outcome|Met Goal|
1207043|NCT00279201|O2|Outcome|Did Not Meet Goal|
1207044|NCT00279201|O1|Outcome|Met Goal|
1207045|NCT00279201|O2|Outcome|Did Not Meet Goal|
1207046|NCT00279201|O1|Outcome|Met Goal|
1207047|NCT00279201|O2|Outcome|Did Not Meet Goal|
1207048|NCT00279201|O1|Outcome|Met Goal|
1207049|NCT00279201|O2|Outcome|Did Not Meet Goal|
1207050|NCT00279201|O1|Outcome|Met Goal|
1207051|NCT00279201|O2|Outcome|Did Not Meet Goal|
1207052|NCT00279201|O1|Outcome|Met Goal|
1207053|NCT00279201|O2|Outcome|Did Not Meet Goal|
1207054|NCT00279201|O1|Outcome|Met Goal|
1207055|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
1207056|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
1207057|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
1207058|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
1207059|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
1207060|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
1207061|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
1207062|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
1207063|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
1207064|NCT00279201|O1|Outcome|Insulin Gargine|Insulin glargine for 24 weeks.
1207065|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
1207129|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
1207066|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
1207067|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
1207068|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
1207069|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
1207070|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
1207071|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
1207072|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
1207073|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
1207074|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
1207075|NCT00279201|O4|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
1207076|NCT00279201|O3|Outcome|Basal Bolus Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
1207077|NCT00279201|O2|Outcome|Lispro LM Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
1207078|NCT00279201|O1|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
1207079|NCT00279201|O2|Outcome|Lispro Low Mix|Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
1207080|NCT00279201|O1|Outcome|Insulin Glargine|Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
1207081|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
1207082|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
1207083|NCT00279201|E8|Reported Event|Lispro LM Maintenance|
1207084|NCT00279201|E7|Reported Event|Insulin Glargine Maintenance|
1207085|NCT00279201|E6|Reported Event|Basal Bolus Prior Glargine Addendum|
1207086|NCT00279201|E5|Reported Event|Basal Bolus Prior Lispro LM Addendum|
1207087|NCT00279201|E4|Reported Event|Lispro LM Prior Glargine Addendum|
1207088|NCT00279201|E3|Reported Event|Lispro Mid Mix Prior Lispro LM Addendum|
1207089|NCT00279201|E2|Reported Event|Lispro LM Initiation|
1207090|NCT00279201|E1|Reported Event|Insulin Glargine Initiation|
1207091|NCT00278993|B1|Baseline|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
1207092|NCT00278993|P1|Participant Flow|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
1207093|NCT00278993|O1|Outcome|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
1207094|NCT00278993|O1|Outcome|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
1207095|NCT00278993|O1|Outcome|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
1207096|NCT00278993|O1|Outcome|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
1207097|NCT00278993|O1|Outcome|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
1207098|NCT00278993|E1|Reported Event|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
1207099|NCT00278954|B1|Baseline|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
1207101|NCT00278954|O1|Outcome|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
1207102|NCT00278954|O1|Outcome|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
1207103|NCT00278954|O1|Outcome|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
1207104|NCT00278954|O1|Outcome|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
1207105|NCT00278954|O1|Outcome|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
1207106|NCT00278954|E1|Reported Event|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
1207107|NCT00278915|B1|Baseline|Fulvestrant|Fulvestrant (4 mg / kg)
1207108|NCT00278915|P1|Participant Flow|Fulvestrant|Fulvestrant (4 mg / kg)
1207109|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
1207110|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
1207111|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
1207112|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
1207113|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
1207114|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
1207115|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
1207116|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
1207117|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
1207118|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
1207119|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
1207120|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
1207121|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
1207122|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
1207123|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
1207124|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
1207125|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
1207126|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
1207127|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
1207128|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
1207131|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
1207132|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
1207133|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
1207134|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
1207135|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
1207136|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
1207137|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
1207138|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
1207139|NCT00278915|E1|Reported Event|Fulvestrant|Fulvestrant (4 mg / kg)
1207140|NCT00278889|B4|Baseline|Total|Total of all reporting groups
1207141|NCT00278889|B3|Baseline|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
1207142|NCT00278889|B2|Baseline|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
1207143|NCT00278889|B1|Baseline|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
1207144|NCT00278889|P3|Participant Flow|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
1207145|NCT00278889|P2|Participant Flow|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
1207146|NCT00278889|P1|Participant Flow|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
1207147|NCT00278889|O3|Outcome|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
1207148|NCT00278889|O2|Outcome|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
1207149|NCT00278889|O1|Outcome|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
1207150|NCT00278889|O3|Outcome|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
1207151|NCT00278889|O2|Outcome|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
1207152|NCT00278889|O1|Outcome|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
1207153|NCT00278889|O3|Outcome|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
1207154|NCT00278889|O2|Outcome|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
1207155|NCT00278889|O1|Outcome|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
1207156|NCT00278889|O3|Outcome|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
1207157|NCT00278889|O2|Outcome|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
1207158|NCT00278889|O1|Outcome|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
1207159|NCT00278889|O3|Outcome|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
1207160|NCT00278889|O2|Outcome|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
1207161|NCT00278889|O1|Outcome|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
1207162|NCT00278889|O3|Outcome|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
1207163|NCT00278889|O2|Outcome|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
1207164|NCT00278889|O1|Outcome|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
1207165|NCT00278889|O3|Outcome|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
1207166|NCT00278889|O2|Outcome|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
1207167|NCT00278889|O1|Outcome|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
1207168|NCT00278889|E3|Reported Event|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
1207169|NCT00278889|E2|Reported Event|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
1207170|NCT00278889|E1|Reported Event|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
1207171|NCT00278876|B1|Baseline|Imatinib Mesylate|patients receiving adjuvant imatinib mesylate
1207172|NCT00278876|P1|Participant Flow|Imatinib Mesylate|imatinib mesylate 400 mg daily for 2 years
1207173|NCT00278876|O1|Outcome|Imatinib Mesylate|"patients receiving adjuvant imatinib mesylate~Imatinib mesylate (Glivec): Imatinib mesylate 400mg/day per oral (day 1-28) every 4 weeks"
1207174|NCT00278876|O1|Outcome|Imatinib Mesylate|"patients receiving adjuvant imatinib mesylate~Imatinib mesylate (Glivec): Imatinib mesylate 400mg/day per oral (day 1-28) every 4 weeks"
1207175|NCT00278876|O1|Outcome|Imatinib Mesylate|"patients receiving adjuvant imatinib mesylate~Imatinib mesylate (Glivec): Imatinib mesylate 400mg/day per oral (day 1-28) every 4 weeks"
1207176|NCT00278876|E1|Reported Event|Imatinib Mesylate|"patients receiving adjuvant imatinib mesylate~Imatinib mesylate (Glivec): Imatinib mesylate 400mg/day per oral (day 1-28) every 4 weeks"
1207177|NCT00278863|B3|Baseline|Total|Total of all reporting groups
1207178|NCT00278863|B2|Baseline|Capecitabine 2 Weeks on/1 Week Off|Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1–14 of a 21-day cycle.
1207179|NCT00278863|B1|Baseline|S-1 for 2 Weeks on/1 Week Off|S-1 was given orally two times daily for 28 days, followed by 14 days’ rest. Three dosage levels of S-1 were defined according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40mg two times daily; BSA, 1.25 to 1.5 m2, 50 mg, two times daily; and BSA more than 1.5 m2, 60 mg two times daily.
1207180|NCT00278863|P2|Participant Flow|Capecitabine 2 Weeks on/1 Week Off|Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1–14 of a 21-day cycle.
1207181|NCT00278863|P1|Participant Flow|S-1 for 2 Week on/1 Week Off|S-1 was given orally two times daily for 28 days, followed by 14 days’ rest. Three dosage levels of S-1 were defined according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40mg two times daily; BSA, 1.25 to 1.5 m2, 50 mg, two times daily; and BSA more than 1.5 m2, 60 mg two times daily.
1207182|NCT00278863|O2|Outcome|Capecitabine 2 Weeks on/1 Week Off|Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1–14 of a 21-day cycle.
1207183|NCT00278863|O1|Outcome|S-1 for 2 Week on/1 Week Off|S-1 was given orally two times daily for 28 days, followed by 14 days’ rest. Three dosage levels of S-1 were defined according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40mg two times daily; BSA, 1.25 to 1.5 m2, 50 mg, two times daily; and BSA more than 1.5 m2, 60 mg two times daily.
1207184|NCT00278863|O2|Outcome|Capecitabine 2 Weeks on/1 Week Off|Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1–14 of a 21-day cycle.
1207185|NCT00278863|O1|Outcome|S-1 for 2 Week on/1 Week Off|S-1 was given orally two times daily for 28 days, followed by 14 days’ rest. Three dosage levels of S-1 were defined according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40mg two times daily; BSA, 1.25 to 1.5 m2, 50 mg, two times daily; and BSA more than 1.5 m2, 60 mg two times daily.
1207254|NCT00277394|B3|Baseline|Total|Total of all reporting groups
1207186|NCT00278863|E2|Reported Event|Capecitabine 2 Weeks on/1 Week Off|Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1–14 of a 21-day cycle.
1207187|NCT00278863|E1|Reported Event|S-1 for 2 Week on/1 Week Off|S-1 was given orally two times daily for 28 days, followed by 14 days’ rest. Three dosage levels of S-1 were defined according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40mg two times daily; BSA, 1.25 to 1.5 m2, 50 mg, two times daily; and BSA more than 1.5 m2, 60 mg two times daily.
1207188|NCT00278655|B1|Baseline|Stem Cell Transplantation|"All participants will undergo stem cell transplantation after receiving conditioning regimen.~hematopoietic stem cell transplantation : Autologous hematopoietic stem cell transplantation"
1207189|NCT00278655|P1|Participant Flow|Autologous Hematopoietic Stem Cell Transplantation|Patient's own blood stem cells collected after mobilization with cyclophosphamide (2.0 gm/m²)and granulocyte colony-stimulating factor (G-CSF) (5-10mcg/kg/day.Collected stem cells given back to the patient after receiving conditioning regimen (Cyclophosphamide 50 mg/kg/day for four days and either 20 mg alemtuzumab or 6mg/kg rabbit antithymocyte globulin.
1207190|NCT00278655|O1|Outcome|Autologous Hematopoietic Stem Cell Transplantation|Patient's own blood stem cells collected after mobilization with cyclophosphamide (2.0 gm/m²)and G-CSF (5-10 mcg/kg/day.Collected stem cells given back to the patient after receiving conditioning regimen (Cyclophosphamide 50 mg/kg/day for four days and either 20 mg alemtuzumab or 6mg/kg rabbit antithymocyte globulin.
1207191|NCT00278655|O1|Outcome|Stem Cell Transplantation|Autologous hematopoietic stem cell transplantation Peripheral blood stem cells were mobilised with 2g per square m intravenous (IV) cyclophosphamide (CY) followed by 10 µg per kg subcutaneous filgrastim daily from day 5. After neutrophil recovery, the mobilised cells were collected by apheresis. The recovered cells were unselected and cryopreserved. There was at least three weeks between mobilisation and the conditioning regimen. The conditioning regimen used was 200 mg per kg intravenous CY , given in four equal fractions between day -5 and day -2 with IV mesna, and one 20mg dose of IV alemtuzumab (CAMPATH-1H) given on day -2 with 250 mg intravenous methyl-prednisolone as premedication. Alemtuzumab was changed to rabbit antithymocyte globulin rATG) in the last 4 patients, who received 6 mg per kg rATG over 5 days instead of alemtuzumab . Stem cells wer reinfused 36 h after completion of CY. 5 µg/kg/day filgrastim was given from day 5 until neutrophil recovery.
1207192|NCT00278655|E1|Reported Event|Stem Cell Transplantation|"All participants will undergo stem cell transplantation after receiving conditioning regimen.~hematopoietic stem cell transplantation : Autologous hematopoietic stem cell transplantation"
1207193|NCT00278525|B3|Baseline|Total|Total of all reporting groups
1207194|NCT00278525|B2|Baseline|Standard of Care|medication as standard of care will be given
1207195|NCT00278525|B1|Baseline|Stem Cell Trasplantation|intervention as stem cell transplantation after conditioning regimen
1207196|NCT00278525|P2|Participant Flow|Stem Cell Trasplantation|intervention as stem cell transplantation after conditioning regimen
1207197|NCT00278525|P1|Participant Flow|Standard of Care|Cyclophosphamide will be given as approved immunosuppressive therapy
1207198|NCT00278525|O2|Outcome|Standard of Care|Intravenous (IV) will be given 1000 mg/m2 cyclophosphamide monthly for 6 months.
1207199|NCT00278525|O1|Outcome|Stem Cell Trasplantation|intervention as stem cell transplantation after conditioning regimen
1207200|NCT00278525|O2|Outcome|Standard of Care|Intravenous (IV) will be given 1000 mg/m2 cyclophosphamide monthly for 6 months.
1207201|NCT00278525|O1|Outcome|Stem Cell Trasplantation|intervention as stem cell transplantation after conditioning regimen
1207202|NCT00278525|E2|Reported Event|Standard of Care|medication as standard of care will be given
1207203|NCT00278525|E1|Reported Event|Stem Cell Trasplantation|intervention as stem cell transplantation after conditioning regimen
1207204|NCT00278473|B3|Baseline|Total|Total of all reporting groups
1207205|NCT00278473|B2|Baseline|Supportive Therapy|Social support problem-solving group. Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.
1207206|NCT00278473|B1|Baseline|Meta-Cognitive Therapy|Cognitive behavioral group. Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.
1207207|NCT00278473|P2|Participant Flow|Supportive Therapy|Social support problem-solving group. Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.
1207208|NCT00278473|P1|Participant Flow|Meta-Cognitive Therapy|Cognitive behavioral group. Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.
1207209|NCT00278473|O2|Outcome|Supportive Therapy|Social support problem-solving group. Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.
1207210|NCT00278473|O1|Outcome|Meta-Cognitive Therapy|Cognitive behavioral group. Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.
1207211|NCT00278473|O2|Outcome|Supportive Therapy|Social support problem-solving group. Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.
1207212|NCT00278473|O1|Outcome|Meta-Cognitive Therapy|Cognitive behavioral group. Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.
1207213|NCT00278473|O2|Outcome|Supportive Therapy|Social support problem-solving group. Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.
1207214|NCT00278473|O1|Outcome|Meta-Cognitive Therapy|Cognitive behavioral group. Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.
1207215|NCT00278473|O2|Outcome|Supportive Therapy|Social support problem-solving group. Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.
1208042|NCT00273754|O2|Outcome|Caffeine|Caffeine benzoate
1207216|NCT00278473|O1|Outcome|Meta-Cognitive Therapy|Cognitive behavioral group. Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.
1207217|NCT00278473|O2|Outcome|Supportive Therapy|Social support problem-solving group. Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.
1207218|NCT00278473|O1|Outcome|Meta-Cognitive Therapy|Cognitive behavioral group. Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.
1207219|NCT00278473|O2|Outcome|Supportive Therapy|Social support problem-solving group. Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.
1207220|NCT00278473|O1|Outcome|Meta-Cognitive Therapy|Cognitive behavioral group. Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.
1207221|NCT00278473|E2|Reported Event|Supportive Therapy|Social support problem-solving group. Social support problem-solving focuses on general support, problem solving, and information sharing. Each group consists of 6 to 8 members and sessions are led by a psychologist.
1207222|NCT00278473|E1|Reported Event|Meta-Cognitive Therapy|Cognitive behavioral group. Cognitive behavioral therapy focuses on changing patterns of thinking and behavior. Each group consists of 6 to 8 members and sessions are led by a psychologist.
1207223|NCT00278395|B1|Baseline|Vorinostat|The dose of vorinostat was 300 mg two times a day on the first 3 days of every week on a 4-week cycle.
1207224|NCT00278395|P1|Participant Flow|Vorinostat|The oral dose of vorinostat capsules was 300 mg two times a day for 3 consecutive days every week for 4 weeks, which constitutes on cycle of treatment. Treatment will be administered on an outpatient basis.
1207225|NCT00278395|O1|Outcome|Vorinostat|The dose of Vorinostat was 300 mg BID on the first 3 days of every week on a 4-week cycle. Dose reduction was allowed for adverse events (AE). Treatment was planned until disease progression (PD), death, unacceptable toxicity, or consent withdrawal.
1207226|NCT00278395|E1|Reported Event|Vorinostat|The dose of vorinostat was 300 mg two times a day on the first 3 days of every week on a 4-week cycle.
1207227|NCT00277524|B1|Baseline|Overall|All patients enrolled in OMNI.
1207228|NCT00277524|P4|Participant Flow|Subjects With CRT-D|Subjects implanted with a cardiac resynchronization therapy defibrillator (CRT-D).
1207229|NCT00277524|P3|Participant Flow|Subjects With Dual Chamber ICD|Subjects implanted with a dual chamber implantable cardioverter defibrillator (ICD).
1207230|NCT00277524|P2|Participant Flow|Subjects With Single Chamber ICD|Subjects implanted with a single chamber implantable cardioverter defibrillator (ICD).
1207231|NCT00277524|P1|Participant Flow|Subjects With IPG|Subjects implanted with an implantable pulse generator (IPG).
1207232|NCT00277524|O1|Outcome|ICD/CRT-D Group|Subjects implanted with Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy-Defibrillator (ICD/CRT-D).
1207233|NCT00277524|O4|Outcome|48-month Follow-up|Total subjects with disease progressed at 48 months
1207234|NCT00277524|O3|Outcome|36-month Follow-up|Total subjects with disease progressed at 36 months
1207235|NCT00277524|O2|Outcome|24-month Follow-up|Total subjects with disease progressed at 24 months
1207236|NCT00277524|O1|Outcome|12-month Follow-up|Total subjects with disease progressed at 12 months
1207237|NCT00277524|O2|Outcome|"SCD-HeFT Programming"|OMNI “SCD-HeFT” definition: programming combinations that result in shock therapy only for arrhythmias at cycle lengths of <320 ms or faster and no therapy for arrhythmias at cycle lengths ≥320 ms.
1207326|NCT00276861|E1|Reported Event|Single Arm|
1207593|NCT00275834|O2|Outcome|Zonisamide 200 mg|
1207238|NCT00277524|O1|Outcome|"PainFREE Programming"|OMNI “PainFREE” definition: programming combinations that result in ATP therapy for VT at cycle lengths <320 ms. Programming at cycle lengths ≥320 ms were not mandated.
1207239|NCT00277524|O1|Outcome|ATP During Charging|Patients who had an episode and were programmed with the ATP during charging feature.
1207240|NCT00277524|O2|Outcome|Patients With History of AV Block|Patients with MVP enabled and follow up data available
1207241|NCT00277524|O1|Outcome|Patients Without History of AV Block|Patients with MVP enabled and follow up data available
1207242|NCT00277524|O2|Outcome|ICD (N=1029)|ICD Patients with MVP enabled and follow up data available
1207243|NCT00277524|O1|Outcome|IPG (N=610)|IPG Patients with MVP enabled and follow up data available
1207244|NCT00277524|O1|Outcome|ICD/CRT-D Group|Subjects implanted with ICD/CRT-D
1207245|NCT00277524|O1|Outcome|IPG Group|Subjects implanted with IPG
1207246|NCT00277524|O1|Outcome|Implanted Subjects|All patients enrolled in OMNI.
1207247|NCT00277524|E1|Reported Event||The Medtronic OMNI Study is a post-market observational study conducted in the United States (US). Adverse events were not collected as a part of the OMNI study. Sites were instructed to report applicable events in the same manner as required for any commercially available device, through the Medical Device Reporting (MDR) process.
1207248|NCT00277446|B1|Baseline|Soy Isoflavone Supplement|This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks.
1207249|NCT00277446|P1|Participant Flow|Soy Isoflavone Supplement|This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks.
1207250|NCT00277446|O1|Outcome|Soy Isoflavone Supplement|This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks.
1207251|NCT00277446|O1|Outcome|Soy Isoflavone Supplement|This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks.
1207252|NCT00277446|O1|Outcome|Soy Isoflavone Supplement|This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks.
1207253|NCT00277446|E1|Reported Event|Soy Isoflavone Supplement|This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks.
1207255|NCT00277394|B2|Baseline|Heparin|Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
1207256|NCT00277394|B1|Baseline|Innohep®|innohep® 175 anti-Xa IU/kg once daily
1207257|NCT00277394|P2|Participant Flow|Heparin|Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
1207258|NCT00277394|P1|Participant Flow|Innohep®|innohep® 175 anti-Xa IU/kg once daily
1207259|NCT00277394|O2|Outcome|Heparin|Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
1207260|NCT00277394|O1|Outcome|Innohep®|innohep® 175 anti-Xa IU/kg once daily
1207261|NCT00277394|O2|Outcome|Heparin|Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
1207262|NCT00277394|O1|Outcome|Innohep®|innohep® 175 anti-Xa IU/kg once daily
1207263|NCT00277394|O2|Outcome|Heparin|Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
1207264|NCT00277394|O1|Outcome|Innohep®|innohep® 175 anti-Xa IU/kg once daily
1207265|NCT00277394|E2|Reported Event|Heparin|Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
1207266|NCT00277394|E1|Reported Event|Innohep®|innohep® 175 anti-Xa IU/kg once daily
1207267|NCT00277355|B3|Baseline|Total|Total of all reporting groups
1207268|NCT00277355|B2|Baseline|Matching Placebo Twice Daily|Matching placebo twice daily (minocycline to placebo 3:1 ratio randomization.
1207269|NCT00277355|B1|Baseline|Minocycline 100 mg Twice Daily|Minocycline 100 mg/twice daily (minocycline to placebo 3:1 ratio randomization).
1207270|NCT00277355|P2|Participant Flow|Matching Placebo Twice Daily|Matching placebo twice daily (minocycline to placebo 3:1 ratio randomization).
1207271|NCT00277355|P1|Participant Flow|Minocycline 100 mg Twice Daily|Minocycline 100 mg/twice daily (minocycline to placebo 3:1 ratio randomization).
1207272|NCT00277355|O2|Outcome|Matching Placebo Twice Daily|Matching placebo twice daily (minocycline to placebo 3:1 ratio randomization).
1207273|NCT00277355|O1|Outcome|Minocycline 100 mg Twice Daily|Minocycline 100 mg/twice daily (minocycline to placebo 3:1 ratio randomization).
1207274|NCT00277355|O2|Outcome|Matching Placebo Twice Daily|Matching placebo twice daily (minocycline to placebo 3:1 ratio randomization.
1207275|NCT00277355|O1|Outcome|Minocycline 100 mg Twice Daily|Minocycline 100 mg/twice daily (minocycline to placebo 3:1 ratio randomization).
1207276|NCT00277355|E2|Reported Event|Matching Placebo Twice Daily|Matching placebo twice daily (minocycline to placebo 3:1 ratio randomization.
1207277|NCT00277355|E1|Reported Event|Minocycline 100 mg Twice Daily|Minocycline 100 mg/twice daily (minocycline to placebo 3:1 ratio randomization).
1207278|NCT00277212|B1|Baseline|Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 1 (all subjects) - up to 24 weeks
1207279|NCT00277212|P3|Participant Flow|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
1207280|NCT00277212|P2|Participant Flow|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
1207281|NCT00277212|P1|Participant Flow|Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 1 (all subjects) - up to 24 weeks
1207282|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
1207283|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
1207284|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
1207285|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
1207286|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
1207287|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
1207288|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
1207289|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
1207290|NCT00277212|O1|Outcome|Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 1 (all subjects) - up to 24 weeks
1207291|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
1207292|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
1207293|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
1207294|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
1207295|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
1207296|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
1207297|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
1207341|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
1207298|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
1207299|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
1207300|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
1207301|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
1207302|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
1207303|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
1207304|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
1207305|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
1207306|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
1207307|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
1207308|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
1207309|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
1207310|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
1207311|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
1207312|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
1207313|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
1207314|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
1207315|NCT00277212|E3|Reported Event|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
1207316|NCT00277212|E2|Reported Event|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
1207317|NCT00277212|E1|Reported Event|Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 1 (all subjects) - up to 24 weeks
1207318|NCT00277095|B1|Baseline|ProACT|Implantable device
1207319|NCT00277095|P1|Participant Flow|Implantable Device|ProACT Implantable device for treatment of post-prostatectomy stress urinary incontinence in males.
1207320|NCT00277095|O1|Outcome|Urine Loss ( in Grams)|24 hour pad weight(in grams) demonstrating 50% reduction in urine loss (in grams)over 18th month
1207321|NCT00277095|E1|Reported Event|ProACT|Implantable device
1207322|NCT00276861|B1|Baseline|Single Arm|
1207327|NCT00276614|B1|Baseline|Bortezomib|Bortezomib 1.3 mg/m2 given on days 1, 4, 8, 11 of a 21 day cycle.
1207328|NCT00276614|P1|Participant Flow|Bortezomib|Bortezomib 1.3 mg/m2 given on days 1, 4, 8, 11 of a 21 day cycle.
1207329|NCT00276614|O1|Outcome|Bortezomib|Bortezomib 1.3 mg/m2 given on days 1, 4, 8, 11 of a 21 day cycle.
1207330|NCT00276614|E1|Reported Event|Bortezomib|Bortezomib 1.3 mg/m2 given on days 1, 4, 8, 11 of a 21 day cycle.
1207331|NCT00276549|B1|Baseline|Gemcitabine (Gemzar) and Docetaxel (Taxotere)|Gemcitabine (Gemzar) 800 mg/m2 administered intravenously over 30 to 60 minutes on Day 1 and 8 of each treatment cycle and docetaxel (Taxotere) 75 mg/m2 administered intravenously over 30 to 60 minutes on Day 8 followed the Day 8 infusion of gemcitabine.
1207332|NCT00276549|P1|Participant Flow|Gemcitabine (Gemzar) and Docetaxel (Taxotere)|Gemcitabine (Gemzar) 800 mg/m2 administered intravenously over 30 to 60 minutes on Day 1 and 8 of each treatment cycle and docetaxel (Taxotere) 75 mg/m2 administered intravenously over 30 to 60 minutes on Day 8 followed the Day 8 infusion of gemcitabine.
1207333|NCT00276549|O1|Outcome|Gemcitabine (Gemzar) and Docetaxel (Taxotere)|Gemcitabine (Gemzar) 800 mg/m2 administered intravenously over 30 to 60 minutes on Day 1 and 8 of each treatment cycle and docetaxel (Taxotere) 75 mg/m2 administered intravenously over 30 to 60 minutes on Day 8 followed the Day 8 infusion of gemcitabine.
1207334|NCT00276549|O1|Outcome|Gemcitabine (Gemzar) and Docetaxel (Taxotere)|Gemcitabine (Gemzar) 800 mg/m2 administered intravenously over 30 to 60 minutes on Day 1 and 8 of each treatment cycle and docetaxel (Taxotere) 75 mg/m2 administered intravenously over 30 to 60 minutes on Day 8 followed the Day 8 infusion of gemcitabine.
1207335|NCT00276549|E1|Reported Event|Gemcitabine (Gemzar) and Docetaxel (Taxotere)|Gemcitabine (Gemzar) 800 mg/m2 administered intravenously over 30 to 60 minutes on Day 1 and 8 of each treatment cycle and docetaxel (Taxotere) 75 mg/m2 administered intravenously over 30 to 60 minutes on Day 8 followed the Day 8 infusion of gemcitabine.
1207336|NCT00276484|B3|Baseline|Total|Total of all reporting groups
1207337|NCT00276484|B2|Baseline|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
1207338|NCT00276484|B1|Baseline|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
1207339|NCT00276484|P2|Participant Flow|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
1207340|NCT00276484|P1|Participant Flow|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
1208043|NCT00273754|O1|Outcome|Placebo|Normal Saline
1207342|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
1207343|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
1207344|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
1207345|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
1207346|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
1207347|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
1207348|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
1207349|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
1207350|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
1207351|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
1207352|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
1207353|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
1207354|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
1207355|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
1207356|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
1207357|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
1207358|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
1207359|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
1207360|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
1207361|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
1207362|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
1207363|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
1207364|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
1207365|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
1207366|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
1207367|NCT00276484|E2|Reported Event|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
1207368|NCT00276484|E1|Reported Event|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
1207369|NCT00276458|B3|Baseline|Total|Total of all reporting groups
1207370|NCT00276458|B2|Baseline|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
1207371|NCT00276458|B1|Baseline|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
1207372|NCT00276458|P2|Participant Flow|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
1207373|NCT00276458|P1|Participant Flow|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
1207374|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
1207375|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
1207376|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
1207377|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
1207378|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
1207379|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
1207380|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
1207544|NCT00276016|B7|Baseline|Total|Total of all reporting groups
1207381|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
1207382|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
1207383|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
1207384|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
1207385|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
1207386|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
1207387|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
1207388|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
1207389|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
1207390|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
1207391|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
1207392|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
1207393|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
1207394|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
1207395|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
1207396|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
1207397|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
1207398|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
1207399|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
1207400|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
1207401|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
1207402|NCT00276458|E2|Reported Event|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
1207403|NCT00276458|E1|Reported Event|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
1207404|NCT00276419|B3|Baseline|Total|Total of all reporting groups
1207485|NCT00276159|B1|Baseline|852A Treatment|Patients receiving at least 12 doses of 852A.
1207405|NCT00276419|B2|Baseline|Diclofenac First, Then Placebo (Arm B)|Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks.
1207406|NCT00276419|B1|Baseline|Placebo First, Then Diclofenac (Arm A)|Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
1207407|NCT00276419|P2|Participant Flow|Diclofenac First, Then Placebo (Arm B)|Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks.
1207408|NCT00276419|P1|Participant Flow|Placebo First, Then Diclofenac (Arm A)|Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
1207409|NCT00276419|O2|Outcome|Diclofenac First, Then Placebo (Arm B)|Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks.
1207410|NCT00276419|O1|Outcome|Placebo First, Then Diclofenac (Arm A)|Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
1207411|NCT00276419|O2|Outcome|Diclofenac First, Then Placebo (Arm B)|Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks.
1207412|NCT00276419|O1|Outcome|Placebo First, Then Diclofenac (Arm A)|Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
1207413|NCT00276419|O2|Outcome|Diclofenac First, Then Placebo (Arm B)|Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks.
1207414|NCT00276419|O1|Outcome|Placebo First, Then Diclofenac (Arm A)|Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
1207415|NCT00276419|E2|Reported Event|Diclofenac|Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
1207416|NCT00276419|E1|Reported Event|Placebo|Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks
1207417|NCT00276406|B3|Baseline|Total|Total of all reporting groups
1207418|NCT00276406|B2|Baseline|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
1207419|NCT00276406|B1|Baseline|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
1207420|NCT00276406|P2|Participant Flow|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
1207421|NCT00276406|P1|Participant Flow|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
1207422|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
1207423|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
1207424|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
1207583|NCT00275834|O3|Outcome|Zonisamide 400 mg|
1207584|NCT00275834|O2|Outcome|Zonisamide 200 mg|
1207585|NCT00275834|O1|Outcome|Placebo|
1207425|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
1207426|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
1207427|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
1207428|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
1207429|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
1207430|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
1207431|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
1207432|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
1207433|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
1207434|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
1207435|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
1207436|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
1208044|NCT00273754|O2|Outcome|Caffeine|Caffeine benzoate
1207437|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
1207438|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
1207439|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
1207440|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
1207441|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
1207442|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
1207443|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
1207444|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
1207445|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
1207446|NCT00276406|E2|Reported Event|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
1207447|NCT00276406|E1|Reported Event|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
1207448|NCT00276250|B4|Baseline|Total|Total of all reporting groups
1207449|NCT00276250|B3|Baseline|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
1207450|NCT00276250|B2|Baseline|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
1207451|NCT00276250|B1|Baseline|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
1207452|NCT00276250|P3|Participant Flow|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
1207453|NCT00276250|P2|Participant Flow|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
1207454|NCT00276250|P1|Participant Flow|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
1207586|NCT00275834|O3|Outcome|Zonisamide 400 mg|
1207587|NCT00275834|O2|Outcome|Zonisamide 200 mg|
1207455|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
1207456|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
1207457|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
1207458|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
1207459|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
1207460|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
1207461|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
1207462|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
1207486|NCT00276159|P1|Participant Flow|852A Treatment|Patients receiving at least 12 doses of 852A.
1207487|NCT00276159|O1|Outcome|852A Treatment|Patients receiving at least 12 doses of 852A.
1207463|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
1207464|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
1207465|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
1207466|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
1207467|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
1207468|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
1207469|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
1207470|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
1207471|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
1207472|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
1207473|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
1207474|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
1207475|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
1207476|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
1207477|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
1207588|NCT00275834|O1|Outcome|Placebo|
1207594|NCT00275834|O1|Outcome|Placebo|
1207478|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
1207479|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
1207480|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
1207481|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
1207482|NCT00276250|E3|Reported Event|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
1207483|NCT00276250|E2|Reported Event|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
1207484|NCT00276250|E1|Reported Event|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
1207488|NCT00276159|O1|Outcome|852A Treatment|Patients receiving at least 12 doses of 852A.
1207489|NCT00276159|O1|Outcome|852A Treatment|Patients receiving at least 12 doses of 852A.
1207490|NCT00276159|O1|Outcome|852A Treatment|Patients receiving at least 12 doses of 852A.
1207491|NCT00276159|E1|Reported Event|852A Treatment|Patients receiving at least 12 doses of 852A.
1207492|NCT00276094|B4|Baseline|Total|Total of all reporting groups
1207493|NCT00276094|B3|Baseline|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207494|NCT00276094|B2|Baseline|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207495|NCT00276094|B1|Baseline|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207496|NCT00276094|P3|Participant Flow|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207497|NCT00276094|P2|Participant Flow|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207498|NCT00276094|P1|Participant Flow|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207499|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207500|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207501|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207502|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207503|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207504|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207505|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207506|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207507|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207508|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207509|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207510|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207629|NCT00275561|O2|Outcome|Placebo|Placebo inhaler swallowed bid for 6 weeks
1207630|NCT00275561|O1|Outcome|Fluticasone|Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
1207511|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207512|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207513|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207514|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207515|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207516|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207517|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207518|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207519|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207520|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207521|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207522|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207523|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207524|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207525|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207526|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207527|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207528|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207529|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207530|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207531|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207532|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207533|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207534|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207535|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207536|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207537|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207538|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207539|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207540|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207541|NCT00276094|E3|Reported Event|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207542|NCT00276094|E2|Reported Event|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207543|NCT00276094|E1|Reported Event|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
1207545|NCT00276016|B6|Baseline|Placebo, Pseudoephedrine, Phenylephrine|Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration
1207546|NCT00276016|B5|Baseline|Pseudoephedrine, Phenylephrine, Placebo|"Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release~12 mg capsules for oral administration. Placebo: Placebo capsules."
1207547|NCT00276016|B4|Baseline|Phenylephrine, Placebo, Pseudoephedrine|Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
1207548|NCT00276016|B3|Baseline|Placebo, Phenylephrine, Pseudoephedrine|Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
1207549|NCT00276016|B2|Baseline|Pseudoephedrine, Placebo, Phenylephrine|Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration.
1207550|NCT00276016|B1|Baseline|Phenylephrine, Pseudoephedrine, Placebo|Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules
1207551|NCT00276016|P6|Participant Flow|Placebo, Pseudoephedrine, Phenylephrine|Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration
1207552|NCT00276016|P5|Participant Flow|Pseudoephedrine, Phenylephrine, Placebo|"Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release~12 mg capsules for oral administration. Placebo: Placebo capsules."
1207553|NCT00276016|P4|Participant Flow|Phenylephrine, Placebo, Pseudoephedrine|Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
1207554|NCT00276016|P3|Participant Flow|Placebo, Phenylephrine, Pseudoephedrine|Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
1207555|NCT00276016|P2|Participant Flow|Pseudoephedrine, Placebo, Phenylephrine|Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration.
1207556|NCT00276016|P1|Participant Flow|Phenylephrine, Pseudoephedrine, Placebo|Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules
1207557|NCT00276016|O2|Outcome|Placebo|
1207558|NCT00276016|O1|Outcome|Pseudoephedrine|
1207559|NCT00276016|O2|Outcome|Phenylephrine|
1207560|NCT00276016|O1|Outcome|Placebo|
1207561|NCT00276016|E3|Reported Event|Placebo|Placebo: Placebo capsules.
1207562|NCT00276016|E2|Reported Event|Pseudoephedrine|Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
1207563|NCT00276016|E1|Reported Event|Phenylephrine|Phenylephrine: Immediate-release 12 mg capsules for oral administration.
1207564|NCT00275834|B4|Baseline|Total|Total of all reporting groups
1207565|NCT00275834|B3|Baseline|Zonisamide 400 mg|
1207566|NCT00275834|B2|Baseline|Zonisamide 200 mg|
1207567|NCT00275834|B1|Baseline|Placebo|
1207568|NCT00275834|P3|Participant Flow|Zonisamide 400 mg|
1207569|NCT00275834|P2|Participant Flow|Zonisamide 200 mg|Dosing of matching placebo was identical.
1207570|NCT00275834|P1|Participant Flow|Placebo|"Zonisamide 100 mg and placebo capsules were prepared in accordance with Good Manufacturing Practice (GMP) guidelines in Duke Compounding Facility with active pharmaceutical ingredient (Sochinaz SA, Switzerland, distributed by Bachem Americas, King of Prussia, Pennsylvania) plus dextrose as an inactive ingredient. Identical-looking placebo capsules contained dextrose.~Each capsule contained zonisamide 100 mg or placebo, with patients and study staff blinded to contents. Dose was gradually titrated upward as follows: 1 capsule for 15 days, 2 during days 16-30, 3 capsules during days 31-45, and 4 from day 46 onward. The entire dose was taken at night. Blinded dose reduction was allowed and dose increase could be withheld. Patients had the option to discontinue the drug and remain in the study receiving only diet and lifestyle counseling."
1207571|NCT00275834|O3|Outcome|Zonisamide 400 mg|
1207572|NCT00275834|O2|Outcome|Zonisamide 200 mg|Dosing of matching placebo was identical.
1207573|NCT00275834|O1|Outcome|Placebo|"Zonisamide 100 mg and placebo capsules were prepared in accordance with Good Manufacturing Practice (GMP) guidelines in Duke Compounding Facility with active pharmaceutical ingredient (Sochinaz SA, Switzerland, distributed by Bachem Americas, King of Prussia, Pennsylvania) plus dextrose as an inactive ingredient. Identical-looking placebo capsules contained dextrose.~Each capsule contained zonisamide 100 mg or placebo, with patients and study staff blinded to contents. Dose was gradually titrated upward as follows: 1 capsule for 15 days, 2 during days 16-30, 3 capsules during days 31-45, and 4 from day 46 onward. The entire dose was taken at night. Blinded dose reduction was allowed and dose increase could be withheld. Patients had the option to discontinue the drug and remain in the study receiving only diet and lifestyle counseling."
1207574|NCT00275834|O3|Outcome|Zonisamide 400 mg|
1207575|NCT00275834|O2|Outcome|Zonisamide 200 mg|
1207576|NCT00275834|O1|Outcome|Placebo|
1207577|NCT00275834|O3|Outcome|Zonisamide 400 mg|
1207578|NCT00275834|O2|Outcome|Zonisamide 200 mg|Dosing of matching placebo was identical.
1207579|NCT00275834|O1|Outcome|Placebo|"Zonisamide 100 mg and placebo capsules were prepared in accordance with Good Manufacturing Practice (GMP) guidelines in Duke Compounding Facility with active pharmaceutical ingredient (Sochinaz SA, Switzerland, distributed by Bachem Americas, King of Prussia, Pennsylvania) plus dextrose as an inactive ingredient. Identical-looking placebo capsules contained dextrose.~Each capsule contained zonisamide 100 mg or placebo, with patients and study staff blinded to contents. Dose was gradually titrated upward as follows: 1 capsule for 15 days, 2 during days 16-30, 3 capsules during days 31-45, and 4 from day 46 onward. The entire dose was taken at night. Blinded dose reduction was allowed and dose increase could be withheld. Patients had the option to discontinue the drug and remain in the study receiving only diet and lifestyle counseling."
1207580|NCT00275834|O3|Outcome|Zonisamide 400 mg|
1207581|NCT00275834|O2|Outcome|Zonisamide 200 mg|
1207582|NCT00275834|O1|Outcome|Placebo|
1207595|NCT00275834|E3|Reported Event|Zonisamide 400 mg|
1207596|NCT00275834|E2|Reported Event|Zonisamide 200 mg|
1207597|NCT00275834|E1|Reported Event|Placebo|
1207598|NCT00275821|B4|Baseline|Total|Total of all reporting groups
1207599|NCT00275821|B3|Baseline|Ranibizumab 0.3 mg Monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
1207600|NCT00275821|B2|Baseline|Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
1207601|NCT00275821|B1|Baseline|Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
1207602|NCT00275821|P3|Participant Flow|Ranibizumab 0.3 mg Monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
1207603|NCT00275821|P2|Participant Flow|Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
1207631|NCT00275561|E2|Reported Event|Placebo|Placebo inhaler swallowed bid for 6 weeks
1207632|NCT00275561|E1|Reported Event|Fluticasone|Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
1207633|NCT00275392|B3|Baseline|Total|Total of all reporting groups
1207604|NCT00275821|P1|Participant Flow|Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
1207605|NCT00275821|O3|Outcome|Ranibizumab 0.3 mg Monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
1207606|NCT00275821|O2|Outcome|Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
1207607|NCT00275821|O1|Outcome|Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
1207608|NCT00275821|O3|Outcome|Ranibizumab 0.3 mg Monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
1207609|NCT00275821|O2|Outcome|Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
1207610|NCT00275821|O1|Outcome|Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
1207611|NCT00275821|O3|Outcome|Ranibizumab 0.3 mg Monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
1207612|NCT00275821|O2|Outcome|Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
1207613|NCT00275821|O1|Outcome|Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
1207614|NCT00275821|O3|Outcome|Ranibizumab 0.3 mg Monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
1207615|NCT00275821|O2|Outcome|Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
1207616|NCT00275821|O1|Outcome|Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
1210891|NCT00263328|B4|Baseline|Total|Total of all reporting groups
1207617|NCT00275821|E3|Reported Event|Ranibizumab 0.3 mg Monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
1207618|NCT00275821|E2|Reported Event|Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
1207619|NCT00275821|E1|Reported Event|Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
1207620|NCT00275561|B3|Baseline|Total|Total of all reporting groups
1207621|NCT00275561|B2|Baseline|Placebo|Placebo inhaler swallowed bid for 6 weeks
1207622|NCT00275561|B1|Baseline|Fluticasone|Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
1207623|NCT00275561|P2|Participant Flow|Placebo|Placebo inhaler swallowed bid for 6 weeks
1207624|NCT00275561|P1|Participant Flow|Fluticasone|Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
1207625|NCT00275561|O2|Outcome|Placebo|Placebo inhaler swallowed bid for 6 weeks
1207626|NCT00275561|O1|Outcome|Fluticasone|Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
1207627|NCT00275561|O2|Outcome|Placebo|Placebo inhaler swallowed bid for 6 weeks
1207628|NCT00275561|O1|Outcome|Fluticasone|Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
1207634|NCT00275392|B2|Baseline|Placebo|"placebo exercises plus standard balance and gait exercises~Placebo Vestibular rehabilitation: placebo vestibular exercises"
1207635|NCT00275392|B1|Baseline|Vestibular Rehabilitation|"vestibular exercises plus standard balance and gait exercises~Vestibular rehabilitation: vestibular adaptation and substitution exercises"
1207636|NCT00275392|P2|Participant Flow|Placebo|"placebo exercises plus standard balance and gait exercises~Placebo Vestibular rehabilitation: placebo vestibular exercises"
1207637|NCT00275392|P1|Participant Flow|Vestibular Rehabilitation|"vestibular exercises plus standard balance and gait exercises~Vestibular rehabilitation: vestibular adaptation and substitution exercises"
1207638|NCT00275392|O2|Outcome|Placebo|"placebo exercises plus standard balance and gait exercises~Placebo Vestibular rehabilitation: placebo vestibular exercises"
1207639|NCT00275392|O1|Outcome|Vestibular Rehabilitation|"vestibular exercises plus standard balance and gait exercises~Vestibular rehabilitation: vestibular adaptation and substitution exercises"
1207640|NCT00275392|O2|Outcome|Placebo|"placebo exercises plus standard balance and gait exercises~Placebo Vestibular rehabilitation: placebo vestibular exercises"
1207641|NCT00275392|O1|Outcome|Vestibular Rehabilitation|"vestibular exercises plus standard balance and gait exercises~Vestibular rehabilitation: vestibular adaptation and substitution exercises"
1207642|NCT00275392|E2|Reported Event|Placebo|"placebo exercises plus standard balance and gait exercises~Placebo Vestibular rehabilitation: placebo vestibular exercises"
1207643|NCT00275392|E1|Reported Event|Vestibular Rehabilitation|"vestibular exercises plus standard balance and gait exercises~Vestibular rehabilitation: vestibular adaptation and substitution exercises"
1207644|NCT00275340|B3|Baseline|Total|Total of all reporting groups
1207645|NCT00275340|B2|Baseline|Peer Support|In addition to usual care, patients randomly assigned to peer support received individualized pain management and exercise education via home-based peer support delivered by telephone.
1207646|NCT00275340|B1|Baseline|Usual Care|Patients allocated to usual care received the standard education/support offered to patients post coronary artery bypass graft surgery: preoperative/postoperative group education, preoperative video, general information booklet and preoperative/postoperative visits from in-hospital peer volunteers.
1207647|NCT00275340|P2|Participant Flow|Peer Support|In addition to usual care, patients randomly assigned to peer support received individualized pain management and exercise education via home-based peer support delivered by telephone.
1207648|NCT00275340|P1|Participant Flow|Usual Care|Patients allocated to usual care received the standard education/support offered to patients post coronary artery bypass graft surgery: preoperative/postoperative group education, preoperative video, general information booklet and preoperative/postoperative visits from in-hospital peer volunteers.
1207649|NCT00275340|O2|Outcome|Peer Support|In addition to usual care, patients randomly assigned to peer support received individualized pain management and exercise education via home-based peer support delivered by telephone.
1207650|NCT00275340|O1|Outcome|Usual Care|Patients allocated to usual care received the standard education/support offered to patients post coronary artery bypass graft surgery: preoperative/postoperative group education, preoperative video, general information booklet and preoperative/postoperative visits from in-hospital peer volunteers.
1207651|NCT00275301|B1|Baseline|All Subjects Were Open-label and Took the Same Dose.|This was an open-label study so all subjects were in the same group.
1207652|NCT00275301|P1|Participant Flow|All Subjects Took Open-label Olanzapine.|All subjects took open-label olanzapine. Subjects tritrated to up to 10mg
1207653|NCT00275301|O1|Outcome|All Subjects Were Open-label and Took the Same Dose.|This was an open-label study so all subjects were in the same group.
1207654|NCT00275301|E1|Reported Event|All Subjects Were Open-label and Took the Same Dose.|This was an open-label study so all subjects were in the same group.
1207655|NCT00275275|B4|Baseline|Total|Total of all reporting groups
1207656|NCT00275275|B3|Baseline|Mirapex to Requip 24-Hour of 1:5|Conversion factor of Mirapex to Ropinirole 24-Hour of 1:5
1211327|NCT00262080|B4|Baseline|Total|Total of all reporting groups
1207657|NCT00275275|B2|Baseline|Mirapex to Requip 24-Hour of 1:4|Conversion factor of Mirapex to Ropinirole 24-Hour of 1:4
1207658|NCT00275275|B1|Baseline|Mirapex to Requip 24-Hour of 1:3|Conversion factor of Mirapex to Ropinirole 24-Hour of 1:3
1207659|NCT00275275|P3|Participant Flow|Mirapex to Requip 24-Hour of 1:5|Conversion factor of Mirapex to Ropinirole 24-Hour of 1:5
1207660|NCT00275275|P2|Participant Flow|Mirapex to Requip 24-Hour of 1:4|Conversion factor of Mirapex to Ropinirole 24-Hour of 1:4
1207661|NCT00275275|P1|Participant Flow|Mirapex to Requip 24-Hour of 1:3|Conversion factor of Mirapex to Ropinirole 24-Hour of 1:3
1207662|NCT00275275|O2|Outcome|Preferred Mirapex|This is the group that preferred Mirapex to Requip PR
1207663|NCT00275275|O1|Outcome|Preferred Requip PR|This is the group of subjects that preferred Requip PR to Mirapex
1207664|NCT00275275|O2|Outcome|Preferred Mirapex|This group refers to the subjects that preferred Mirapex
1207665|NCT00275275|O1|Outcome|Preferred Requip PR|This group refers to the subjects that preferred Requip PR to Mirapex
1207666|NCT00275275|E2|Reported Event|Preferred Mirapex|These are the subjects that preferred Mirapex to Requip PR at the end of the study
1207667|NCT00275275|E1|Reported Event|Preferred Requip PR|These are the subjects that preferred Requip PR to Mirapex at the end of the study
1207668|NCT00275262|B3|Baseline|Total|Total of all reporting groups
1207669|NCT00275262|B2|Baseline|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
1207670|NCT00275262|B1|Baseline|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
1207671|NCT00275262|P2|Participant Flow|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
1207672|NCT00275262|P1|Participant Flow|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
1207673|NCT00275262|O2|Outcome|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
1207674|NCT00275262|O1|Outcome|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
1207675|NCT00275262|O2|Outcome|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
1207676|NCT00275262|O1|Outcome|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
1207677|NCT00275262|O2|Outcome|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
1207678|NCT00275262|O1|Outcome|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
1207679|NCT00275262|O2|Outcome|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
1207680|NCT00275262|O1|Outcome|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
1207681|NCT00275262|O2|Outcome|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
1207682|NCT00275262|O1|Outcome|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
1207683|NCT00275262|E2|Reported Event|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
1207684|NCT00275262|E1|Reported Event|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
1207685|NCT00275028|B1|Baseline|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1207686|NCT00275028|P1|Participant Flow|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1207687|NCT00275028|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1207688|NCT00275028|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1207689|NCT00275028|E1|Reported Event|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1207690|NCT00275002|B3|Baseline|Total|Total of all reporting groups
1207691|NCT00275002|B2|Baseline|Recurrent Brain Stem Tumors|Participants with recurrent or progressive brain stem tumors receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
1207692|NCT00275002|B1|Baseline|Recurrent High-Grade Gliomas|Participants with recurrent or progressive high-grade gliomas receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
1207739|NCT00274768|E1|Reported Event|Capecitabine|The starting dose of capecitabine was 3,000 mg (total daily dose) given in two divided daily doses for 14 days followed by 7 days of rest (1 cycle = 21 days). Missed doses were not substituted. Treatment was continued until unacceptable toxicity, disease progression, or withdrawal of consent.
1207693|NCT00275002|P2|Participant Flow|Recurrent Brain Stem Tumors|Participants with recurrent or progressive brain stem tumors receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
1207694|NCT00275002|P1|Participant Flow|Recurrent High-Grade Gliomas|Participants with recurrent or progressive high-grade gliomas receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
1207695|NCT00275002|O2|Outcome|Recurrent Brain Stem Tumors|Participants with recurrent or progressive brain stem tumors receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
1207696|NCT00275002|O1|Outcome|Recurrent High-Grade Gliomas|Participants with recurrent or progressive high-grade gliomas receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
1207697|NCT00275002|O2|Outcome|Recurrent Brain Stem Tumors|Participants with recurrent or progressive brain stem tumors receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
1207698|NCT00275002|O1|Outcome|Recurrent High-Grade Gliomas|Participants with recurrent or progressive high-grade gliomas receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
1208045|NCT00273754|O1|Outcome|Placebo|Normal Saline
1207699|NCT00275002|E2|Reported Event|Recurrent Brain Stem Tumors|Participants with recurrent or progressive brain stem tumors receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
1207700|NCT00275002|E1|Reported Event|Recurrent High-Grade Gliomas|Participants with recurrent or progressive high-grade gliomas receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
1207701|NCT00274937|B1|Baseline|Stratum II|AJCC Stage IIb - IV
1207702|NCT00274937|P1|Participant Flow|Stratum II|AJCC Stage IIb - IV
1207703|NCT00274937|O1|Outcome|Stratum II|AJCC Stage IIb - IV
1207704|NCT00274937|O1|Outcome|Stratum II|AJCC Stage IIb - IV
1207705|NCT00274937|O1|Outcome|Stratum II|AJCC Stage IIb - IV
1207706|NCT00274937|O1|Outcome|Stratum II|AJCC Stage IIb - IV
1207707|NCT00274937|E1|Reported Event|Stratum II (Chemotherapy, Chemoprotective Agent, Radiotherapy)|"Patients receive cisplatin IV over 6 hours on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 3 weeks for 3 courses. In weeks 10-18, patients undergo radiation therapy and receive amifostine trihydrate as in stratum I. Patients also receive 3 courses of cisplatin as before.~amifostine trihydrate: Given subcutaneously~fluorouracil: Given IV~cisplatin: Given IV~laboratory biomarker analysis: Correlative studies~radiation therapy: Undergo radiotherapy"
1207708|NCT00274924|B4|Baseline|Total|Total of all reporting groups
1207709|NCT00274924|B3|Baseline|No Mid-Treatment PET|Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who did not have mid-treatment PET scan for any reasons came off study and continued to be followed up for disease progression and survival.
1207710|NCT00274924|B2|Baseline|Group II (PET Negative)|Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who were PET negative after 3 cycles of R-CHOP received 2 more cycles of R-CHOP (6 cycles in total).
1207711|NCT00274924|B1|Baseline|Group I (PET Positive)|Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who were PET positive after 3 cycles of R-CHOP received Rituximab 375 mg/m2 IV Day 1, Ifosfamide 5000 mg/m2 IV over 24 hours Day 2, Carboplatin AUC 5 (max: 800 mg) IV Day 2, Etoposide 100 mg/m2 IV Days 1, 2, 3 (R-ICE), Mesna 5000 mg/m2 IV over 24 hours Day 2, and Filgrastim 5 mcg/kg/day subcutaneous (SC) Day 4 until absolute neutrophil count (ANC) recovery every 14 days for 4 cycles .
1207712|NCT00274924|P3|Participant Flow|No Mid-Treatment PET|Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who did not have mid-treatment PET scan for any reasons came off study and continued to be followed up for disease progression and survival.
1207713|NCT00274924|P2|Participant Flow|Group II (PET Negative)|Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who were PET negative after 3 cycles of R-CHOP received 2 more cycles of R-CHOP (6 cycles in total).
1207740|NCT00274742|B7|Baseline|Total|Total of all reporting groups
1207714|NCT00274924|P1|Participant Flow|Group I (PET Positive)|Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who were PET positive after 3 cycles of R-CHOP received Rituximab 375 mg/m2 IV Day 1, Ifosfamide 5000 mg/m2 IV over 24 hours Day 2, Carboplatin AUC 5 (max: 800 mg) IV Day 2, Etoposide 100 mg/m2 IV Days 1, 2, 3 (R-ICE), Mesna 5000 mg/m2 IV over 24 hours Day 2, and Filgrastim 5 mcg/kg/day subcutaneous (SC) Day 4 until absolute neutrophil count (ANC) recovery every 14 days for 4 cycles .
1207715|NCT00274924|O2|Outcome|Group II (PET Positive)|Eligible and treated patients who were PET positive after 3 cycles of R-CHOP received 4 cycles of R-ICE.
1207716|NCT00274924|O1|Outcome|Group I (PET Negative)|Eligible and treated patients who were PET negative after 3 cycles of R-CHOP received 2 more cycles of R-CHOP (6 cycles in total).
1207717|NCT00274924|O2|Outcome|Group II (PET Positive)|Eligible and treated patients who were PET positive after 3 cycles of R-CHOP received 4 cycles of R-ICE.
1207718|NCT00274924|O1|Outcome|Group I (PET Negative)|Eligible and treated patients who were PET negative after 3 cycles of R-CHOP received 2 more cycles of R-CHOP (6 cycles in total).
1207719|NCT00274924|E3|Reported Event|Step 2 - Mid-treatment PET Negative|Patients who were mid-treatment PET negative and who received additional R-CHOP in step 2 regardless of eligibility.
1207720|NCT00274924|E2|Reported Event|Step 2 - Mid-treatment PET Positive|Patients who were mid-treatment PET positive and who received R-ICE in step 2 regardless of eligibility.
1207721|NCT00274924|E1|Reported Event|Step 1 - All Treated Patients|All treated patients regardless of eligibility.
1207722|NCT00274846|B1|Baseline|Patients With Relapsed/Refractory Acute Myeloid Leukemia|Patients who met study criteria - relapsed or refractory acute myelogenous leukemia - and were enrolled.
1207723|NCT00274846|P1|Participant Flow|Patients With Relapsed/Refractory Acute Myeloid Leukemia|Patients who met study criteria - relapsed or refractory acute myelogenous leukemia - and were enrolled.
1207828|NCT00274716|O4|Outcome|Placebo High BMI|Participants administered placebo tablet once daily for 12 weeks
1208046|NCT00273754|E2|Reported Event|Caffeine|Caffeine benzoate
1207724|NCT00274846|O1|Outcome|Patients With Relapsed/Refractory AML - Evaluable Group|Patients who are evaluable; received adequate (dose of 1.5-8 x 10^7/kg natural killer (NK) cells 14 days after treatment with chemotherapy and allogeneic NK cell-enriched immune therapy.
1207725|NCT00274846|O1|Outcome|Patients Achieving Complete Remission - Responders|Patients who achieved complete remission (CR) as judged by morphological criteria; only these patients can be judged for time to relapse.
1207726|NCT00274846|O1|Outcome|Patients Achieving Complete Remission - Responders|Patients who achieved complete remission (CR) as judged by morphological criteria; only these patients can be judged for time to relapse.
1207727|NCT00274846|O1|Outcome|Patients With Relapsed/Refractory AML - Evaluable Group|Patients who are evaluable; received adequate (dose of 1.5-8 x 10^7/kg natural killer (NK) cells 14 days after treatment with chemotherapy and allogeneic NK cell-enriched immune therapy.
1207728|NCT00274846|O1|Outcome|Patients With Relapsed/Refractory AML - Evaluable Group|Patients who are evaluable; received adequate (dose of 1.5-8 x 10^7/kg natural killer (NK) cells 14 days after treatment with chemotherapy and allogeneic NK cell-enriched immune therapy.
1207729|NCT00274846|E1|Reported Event|Patients With Relapsed/Refractory Acute Myeloid Leukemia|Patients who met study criteria - relapsed or refractory acute myelogenous leukemia - and were enrolled.
1207730|NCT00274781|B1|Baseline|ATO (0.25mg/kg) and GO (3mg/m2)|ATO dosing was based on the phase 2 European Union regimen at a dose of 0.25 mg/kg administered intravenously on Days 1 through 5 during Week 1 and then twice weekly during Weeks 2 to 12, and GO at a dose of 3mg/m2 on Day 8 for 1 or 2 cycles of 12 weeks each.
1207731|NCT00274781|P1|Participant Flow|ATO (0.25mg/kg) and GO (3mg/m2)|ATO dosing was based on the phase 2 European Union regimen at a dose of 0.25 mg/kg administered intravenously on Days 1 through 5 during Week 1 and then twice weekly during Weeks 2 to 12, and GO at a dose of 3mg/m2 on Day 8 for 1 or 2 cycles of 12 weeks each.
1207732|NCT00274781|O1|Outcome|ATO (0.25mg/kg) and GO (3mg/m2)|ATO dosing was based on the phase 2 European Union regimen at a dose of 0.25 mg/kg administered intravenously on Days 1 through 5 during Week 1 and then twice weekly during Weeks 2 to 12, and GO at a dose of 3mg/m2 on Day 8 for 1 or 2 cycles of 12 weeks each.
1207733|NCT00274781|O1|Outcome|ATO (0.25mg/kg) and GO (3mg/m2)|ATO dosing was based on the phase 2 European Union regimen at a dose of 0.25 mg/kg administered intravenously on Days 1 through 5 during Week 1 and then twice weekly during Weeks 2 to 12, and GO at a dose of 3mg/m2 on Day 8 for 1 or 2 cycles of 12 weeks each.
1207734|NCT00274781|O1|Outcome|ATO + GO|"Arsenic Trioxide 0.25 mg/kg D1-5 Week 1/Twice Weekly W2-12 + Gemtuzumab Ozogamicin 3 mg/m^2 D8 for 1 or 2 Cycles of 12 Weeks each~arsenic trioxide: Arsenic trioxide will be administered at a dose of 0.25 mg/kg/day IV over 1-2 hours for 5 consecutive days during the first week. Subsequently, arsenic trioxide will be given at a dose of 0.25mg/kg/day twice a week for 11 additional weeks (weeks 2-12).~gemtuzumab ozogamicin: Gemtuzumab ozogamicin consists of a 2 hr infusion at a dose of 3mg/m2 on day 8 of each 12-week cycle. Gemtuzumab ozogamicin should be administered at a minimum of one hour after the completion of the arsenic trioxide infusion"
1207735|NCT00274781|E1|Reported Event|ATO (0.25mg/kg) and GO (3mg/m2)|ATO dosing was based on the phase 2 European Union regimen at a dose of 0.25 mg/kg administered intravenously on Days 1 through 5 during Week 1 and then twice weekly during Weeks 2 to 12, and GO at a dose of 3mg/m2 on Day 8 for 1 or 2 cycles of 12 weeks each.
1207736|NCT00274768|B1|Baseline|Capecitabine|The starting dose of capecitabine was 3,000 mg (total daily dose) given in two divided daily doses for 14 days followed by 7 days of rest (1 cycle = 21 days). Missed doses were not substituted. Treatment was continued until unacceptable toxicity, disease progression, or withdrawal of consent.
1207737|NCT00274768|P1|Participant Flow|Capecitabine|The starting dose of capecitabine was 3,000 mg (total daily dose) given in two divided daily doses for 14 days followed by 7 days of rest (1 cycle = 21 days). Missed doses were not substituted. Treatment was continued until unacceptable toxicity, disease progression, or withdrawal of consent.
1207738|NCT00274768|O1|Outcome|Capecitabine|The starting dose of capecitabine was 3,000 mg (total daily dose) given in two divided daily doses for 14 days followed by 7 days of rest (1 cycle = 21 days). Missed doses were not substituted. Treatment was continued until unacceptable toxicity, disease progression, or withdrawal of consent.
1207741|NCT00274742|B6|Baseline|Blinatumomab 90 µg/m²/d|Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
1207742|NCT00274742|B5|Baseline|Blinatumomab 60 µg/m²/d Step|Participants received blinatumomab 60 μg/m²/day as continuous intravenous infusion after initial lower doses of 5 and/or 15 μg/m²/day for a total treatment duration of 4-8 weeks in the first treatment cycle.
1207743|NCT00274742|B4|Baseline|Blinatumomab 60 µg/m²/d Flat|Participants received blinatumomab 60 µg/m²/day without a lower dose as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
1207744|NCT00274742|B3|Baseline|Blinatumomab 30 µg/m²/d|Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
1207745|NCT00274742|B2|Baseline|Blinatumomab 15 µg/m²/d|Participants received blinatumomab 15 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
1207746|NCT00274742|B1|Baseline|Blinatumomab ≤ 5 µg/m²/d|Participants received blinatumomab ≤ 5 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
1207747|NCT00274742|P6|Participant Flow|Blinatumomab 90 µg/m²/d|Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
1207748|NCT00274742|P5|Participant Flow|Blinatumomab 60 µg/m²/d Step|Participants received blinatumomab 60 μg/m²/day as continuous intravenous infusion after initial lower doses of 5 and/or 15 μg/m²/day for a total treatment duration of 4-8 weeks in the first treatment cycle.
1207749|NCT00274742|P4|Participant Flow|Blinatumomab 60 µg/m²/d Flat|Participants received blinatumomab 60 µg/m²/day without a lower dose as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
1207750|NCT00274742|P3|Participant Flow|Blinatumomab 30 µg/m²/d|Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
1207751|NCT00274742|P2|Participant Flow|Blinatumomab 15 µg/m²/d|Participants received blinatumomab 15 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
1207829|NCT00274716|O3|Outcome|MK-0916 6.0 mg High BMI|Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
1207752|NCT00274742|P1|Participant Flow|Blinatumomab ≤ 5 µg/m²/d|Participants received blinatumomab ≤ 5 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
1207753|NCT00274742|O6|Outcome|Blinatumomab 90 µg/m²/d|Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
1207754|NCT00274742|O5|Outcome|Blinatumomab 60 µg/m²/d Step|Participants received blinatumomab 60 μg/m²/day as continuous intravenous infusion after initial lower doses of 5 and/or 15 μg/m²/day for a total treatment duration of 4-8 weeks in the first treatment cycle.
1207755|NCT00274742|O4|Outcome|Blinatumomab 60 µg/m²/d Flat|Participants received blinatumomab 60 µg/m²/day without a lower dose as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
1207756|NCT00274742|O3|Outcome|Blinatumomab 30 µg/m²/d|Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
1207757|NCT00274742|O2|Outcome|Blinatumomab 15 µg/m²/d|Participants received blinatumomab 15 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
1207758|NCT00274742|O1|Outcome|Blinatumomab ≤ 5 µg/m²/d|Participants received blinatumomab ≤ 5 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
1207759|NCT00274742|O6|Outcome|Blinatumomab 90 µg/m²/d|Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
1207760|NCT00274742|O5|Outcome|Blinatumomab 60 µg/m²/d Step|Participants received blinatumomab 60 μg/m²/day as continuous intravenous infusion after initial lower doses of 5 and/or 15 μg/m²/day for a total treatment duration of 4-8 weeks in the first treatment cycle.
1207761|NCT00274742|O4|Outcome|Blinatumomab 60 µg/m²/d Flat|Participants received blinatumomab 60 µg/m²/day without a lower dose as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
1207762|NCT00274742|O3|Outcome|Blinatumomab 30 µg/m²/d|Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
1207763|NCT00274742|O2|Outcome|Blinatumomab 15 µg/m²/d|Participants received blinatumomab 15 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
1207764|NCT00274742|O1|Outcome|Blinatumomab ≤ 5 µg/m²/d|Participants received blinatumomab ≤ 5 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
1207765|NCT00274742|O5|Outcome|Blinatumomab 90 µg/m²/d|Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion in the first treatment cycle.
1207766|NCT00274742|O4|Outcome|Blinatumomab 60 µg/m²/d|Participants received blinatumomab 60 µg/m²/day as continuous intravenous infusion in the first treatment cycle.
1207767|NCT00274742|O3|Outcome|Blinatumomab 30 µg/m²/d|Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion in hte first treatment cycle.
1207768|NCT00274742|O2|Outcome|Blinatumomab 15 µg/m²/d|Participants who received blinatumomab 15 µg/m²/day as continuous intravenous infusion in the first treatment cyle.
1207769|NCT00274742|O1|Outcome|Blinatumomab 5 µg/m²/d|Participants who received blinatumomab 5 µg/m²/day as continuous intravenous infusion in the first treatment cycle.
1207770|NCT00274742|O6|Outcome|Blinatumomab 90 µg/m²/d|Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
1207771|NCT00274742|O5|Outcome|Blinatumomab 60 µg/m²/d Step|Participants received blinatumomab 60 μg/m²/day as continuous intravenous infusion after initial lower doses of 5 and/or 15 μg/m²/day for a total treatment duration of 4-8 weeks in the first treatment cycle.
1207772|NCT00274742|O4|Outcome|Blinatumomab 60 µg/m²/d Flat|Participants received blinatumomab 60 µg/m²/day without a lower dose as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
1207773|NCT00274742|O3|Outcome|Blinatumomab 30 µg/m²/d|Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
1207774|NCT00274742|O2|Outcome|Blinatumomab 15 µg/m²/d|Participants received blinatumomab 15 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
1207775|NCT00274742|O1|Outcome|Blinatumomab ≤ 5 µg/m²/d|Participants received blinatumomab ≤ 5 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
1207776|NCT00274742|E7|Reported Event|Blinatumomab Overall|All participants who received any dose of blinatumomab
1207777|NCT00274742|E6|Reported Event|Blinatumomab 90 µg/m²/d|Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
1207778|NCT00274742|E5|Reported Event|Blinatumomab 60 µg/m²/d Step|Participants received blinatumomab 60 μg/m²/day as continuous intravenous infusion after initial lower doses of 5 and/or 15 μg/m²/day for a total treatment duration of 4-8 weeks in the first treatment cycle.
1207779|NCT00274742|E4|Reported Event|Blinatumomab 60 µg/m²/d Flat|Participants received blinatumomab 60 µg/m²/day without a lower dose as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
1207780|NCT00274742|E3|Reported Event|Blinatumomab 30 µg/m²/d|Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
1207781|NCT00274742|E2|Reported Event|Blinatumomab 15 µg/m²/d|Participants received blinatumomab 15 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
1207782|NCT00274742|E1|Reported Event|Blinatumomab ≤ 5 µg/m²/d|Participants received blinatumomab ≤ 5 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
1207783|NCT00274716|B7|Baseline|Total|Total of all reporting groups
1207784|NCT00274716|B6|Baseline|Low BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
1207785|NCT00274716|B5|Baseline|Low BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
1207786|NCT00274716|B4|Baseline|High BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
1207787|NCT00274716|B3|Baseline|High BMI:MK-0916 6mg→MK-0916 6mg|Participants who received MK-0916 6 mg in Phase A and continued on MK-0916 6 mg for 12 weeks in Phase B
1208034|NCT00273754|O2|Outcome|Caffeine|Caffeine benzoate
1207788|NCT00274716|B2|Baseline|High BMI:MK-0736 7mg→Placebo|Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
1207789|NCT00274716|B1|Baseline|High BMI:MK-0736 2mg→Placebo|Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
1207790|NCT00274716|P6|Participant Flow|Low BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
1207791|NCT00274716|P5|Participant Flow|Low BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
1207792|NCT00274716|P4|Participant Flow|High BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
1207793|NCT00274716|P3|Participant Flow|High BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
1207794|NCT00274716|P2|Participant Flow|High BMI:MK-0736 7mg→Placebo|Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
1207795|NCT00274716|P1|Participant Flow|High BMI:MK-0736 2mg→Placebo|Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
1207796|NCT00274716|O6|Outcome|Low BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
1207797|NCT00274716|O5|Outcome|Low BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
1207798|NCT00274716|O4|Outcome|High BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
1207799|NCT00274716|O3|Outcome|High BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
1207800|NCT00274716|O2|Outcome|High BMI:MK-0736 7mg→Placebo|Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
1207801|NCT00274716|O1|Outcome|High BMI:MK-0736 2mg→Placebo|Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
1207802|NCT00274716|O6|Outcome|Low BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
1207803|NCT00274716|O5|Outcome|Low BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
1207804|NCT00274716|O4|Outcome|High BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
1207805|NCT00274716|O3|Outcome|High BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
1207806|NCT00274716|O2|Outcome|High BMI:MK-0736 7mg→Placebo|Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
1207807|NCT00274716|O1|Outcome|High BMI:MK-0736 2mg→Placebo|Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
1207808|NCT00274716|O6|Outcome|Low BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
1207809|NCT00274716|O5|Outcome|Low BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
1207810|NCT00274716|O4|Outcome|High BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
1207811|NCT00274716|O3|Outcome|High BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
1207812|NCT00274716|O2|Outcome|High BMI:MK-0736 7mg→Placebo|Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
1207813|NCT00274716|O1|Outcome|High BMI:MK-0736 2mg→Placebo|Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
1207814|NCT00274716|O6|Outcome|Low BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
1208452|NCT00272311|E4|Reported Event|Arm 4 of 5 Randomized Treatment Arms|650 mg Aspirin
1207815|NCT00274716|O5|Outcome|Low BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
1207816|NCT00274716|O4|Outcome|High BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
1207817|NCT00274716|O3|Outcome|High BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
1207818|NCT00274716|O2|Outcome|High BMI:MK-0736 7mg→Placebo|Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
1207819|NCT00274716|O1|Outcome|High BMI:MK-0736 2mg→Placebo|Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
1207820|NCT00274716|O4|Outcome|Placebo High BMI|Participants administered placebo tablet once daily for 12 weeks
1207821|NCT00274716|O3|Outcome|MK-0916 6.0 mg High BMI|Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
1207822|NCT00274716|O2|Outcome|MK-0736 7.0 mg High BMI|Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
1207823|NCT00274716|O1|Outcome|MK-0736 2.0 mg High BMI|Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
1207824|NCT00274716|O4|Outcome|Placebo High BMI|Participants administered placebo tablet once daily for 12 weeks
1207825|NCT00274716|O3|Outcome|MK-0916 6.0 mg High BMI|Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
1207826|NCT00274716|O2|Outcome|MK-0736 7.0 mg High BMI|Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
1207827|NCT00274716|O1|Outcome|MK-0736 2.0 mg High BMI|Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
1208035|NCT00273754|O1|Outcome|Placebo|Normal Saline
1207830|NCT00274716|O2|Outcome|MK-0736 7.0 mg High BMI|Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
1207831|NCT00274716|O1|Outcome|MK-0736 2.0 mg High BMI|Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
1207832|NCT00274716|O4|Outcome|Placebo High BMI|Participants administered placebo tablet once daily for 12 weeks
1207833|NCT00274716|O3|Outcome|MK-0916 6.0 mg High BMI|Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
1207834|NCT00274716|O2|Outcome|MK-0736 7.0 mg High BMI|Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
1207835|NCT00274716|O1|Outcome|MK-0736 2.0 mg High BMI|Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
1207836|NCT00274716|O4|Outcome|Placebo High BMI|Participants administered placebo tablet once daily for 12 weeks
1207837|NCT00274716|O3|Outcome|MK-0916 6.0 mg High BMI|Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
1207838|NCT00274716|O2|Outcome|MK-0736 7.0 mg High BMI|Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
1207839|NCT00274716|O1|Outcome|MK-0736 2.0 mg High BMI|Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
1207840|NCT00274716|O4|Outcome|Placebo High BMI|Participants administered placebo tablet once daily for 12 weeks
1207841|NCT00274716|O3|Outcome|MK-0916 6.0 mg High BMI|Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
1207842|NCT00274716|O2|Outcome|MK-0736 7.0 mg High BMI|Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
1207843|NCT00274716|O1|Outcome|MK-0736 2.0 mg High BMI|Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
1207844|NCT00274716|O4|Outcome|Placebo High BMI|Participants administered placebo tablet once daily for 12 weeks
1207845|NCT00274716|O3|Outcome|MK-0916 6.0 mg High BMI|Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
1207846|NCT00274716|O2|Outcome|MK-0736 7.0 mg High BMI|Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
1207847|NCT00274716|O1|Outcome|MK-0736 2.0 mg High BMI|Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
1207848|NCT00274716|E6|Reported Event|Low BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
1207849|NCT00274716|E5|Reported Event|Low BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
1207850|NCT00274716|E4|Reported Event|High BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
1207851|NCT00274716|E3|Reported Event|High BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
1207852|NCT00274716|E2|Reported Event|High BMI:MK-0736 7mg→Placebo|Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
1207853|NCT00274716|E1|Reported Event|High BMI:MK-0736 2mg→Placebo|Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
1207854|NCT00274651|B3|Baseline|Total|Total of all reporting groups
1207855|NCT00274651|B2|Baseline|PTCL (ITT Population)|"PTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
1207856|NCT00274651|B1|Baseline|CTCL (ITT Population)|"CTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
1207857|NCT00274651|P2|Participant Flow|Arm B (PTCL, ITT Population)|PXD101 1000 mg/m2 once daily for 5 days every 21 days
1207858|NCT00274651|P1|Participant Flow|Arm A (CTCL, ITT Population)|PXD101 1000 mg/m2 once daily for 5 days every 21 days
1207859|NCT00274651|O1|Outcome|Arm A (CTCL, ITT Population)|"CTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
1207860|NCT00274651|O2|Outcome|Arm B (PTCL, ITT Population)|"PTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
1207861|NCT00274651|O1|Outcome|Arm A (CTCL, ITT Population)|"CTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
1207862|NCT00274651|O2|Outcome|Arm B (PTCL, ITT Population)|"PTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
1207863|NCT00274651|O1|Outcome|Arm A (CTCL, ITT Population)|"CTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
1207864|NCT00274651|O2|Outcome|Arm B (PTCL, ITT Population)|"PTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
1207865|NCT00274651|O1|Outcome|Arm A (CTCL, ITT Population)|"CTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
1207866|NCT00274651|O1|Outcome|PTCL (ITT Population)|"PTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
1207867|NCT00274651|O1|Outcome|Arm A (CTCL, ITT Population)|"CTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
1207868|NCT00274651|E2|Reported Event|Arm B (PTCL, ITT Population)|"PTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
1207869|NCT00274651|E1|Reported Event|Arm A (CTCL, ITT Population)|"CTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
1207870|NCT00274625|B3|Baseline|Total|Total of all reporting groups
1207871|NCT00274625|B2|Baseline|Suture Closure|Control : Incision is closed without the placement of a graft material (standard of care control)
1207872|NCT00274625|B1|Baseline|Surgisis Gold|Surgisis Gold Graft is placed as an underlay following open bariatric surgery.
1207873|NCT00274625|P2|Participant Flow|Suture Closure|Control : Incision is closed without the placement of a graft material (standard of care control)
1207874|NCT00274625|P1|Participant Flow|Surgisis Gold|Surgisis Gold Graft is placed as an underlay following open bariatric surgery.
1207875|NCT00274625|O2|Outcome|Suture Closure|Control : Incision is closed without the placement of a graft material (standard of care control)
1207876|NCT00274625|O1|Outcome|Surgisis Gold|Surgisis Gold Graft is placed as an underlay following open bariatric surgery.
1207877|NCT00274625|E2|Reported Event|Suture Closure|Control : Incision is closed without the placement of a graft material (standard of care control)
1207878|NCT00274625|E1|Reported Event|Surgisis Gold|Surgisis Gold Graft is placed as an underlay following open bariatric surgery.
1207879|NCT00274469|B3|Baseline|Total|Total of all reporting groups
1207880|NCT00274469|B2|Baseline|Anastrozole 1 mg|Anastrozole 1 mg
1207881|NCT00274469|B1|Baseline|Fulvestrant 500 mg|Fulvestrant 500 mg
1207882|NCT00274469|P2|Participant Flow|Anastrozole 1 mg|Anastrozole 1 mg
1207883|NCT00274469|P1|Participant Flow|Fulvestrant 500 mg|Fulvestrant 500 mg
1207884|NCT00274469|O2|Outcome|Anastrozole 1 mg|Anastrozole 1 mg
1207885|NCT00274469|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
1207886|NCT00274469|O2|Outcome|Anastrozole 1 mg|Anastrozole 1 mg
1207887|NCT00274469|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
1207888|NCT00274469|O2|Outcome|Anastrozole 1 mg|Anastrozole 1 mg
1207889|NCT00274469|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
1207890|NCT00274469|O2|Outcome|Anastrozole 1 mg|Anastrozole 1 mg
1207891|NCT00274469|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
1207892|NCT00274469|O2|Outcome|Anastrozole 1 mg|Anastrozole 1 mg
1207893|NCT00274469|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
1207894|NCT00274469|E2|Reported Event|Anastrozole 1 mg|Anastrozole 1 mg
1207895|NCT00274469|E1|Reported Event|Fulvestrant 500 mg|Fulvestrant 500 mg
1207896|NCT00274456|B5|Baseline|Total|Total of all reporting groups
1207897|NCT00274456|B4|Baseline|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
1207898|NCT00274456|B3|Baseline|ABI-007 150 mg/m^2|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest.
1207899|NCT00274456|B2|Baseline|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
1207900|NCT00274456|B1|Baseline|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
1207901|NCT00274456|P4|Participant Flow|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
1207902|NCT00274456|P3|Participant Flow|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
1207903|NCT00274456|P2|Participant Flow|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
1207904|NCT00274456|P1|Participant Flow|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
1207905|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
1207906|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
1207907|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
1207908|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
1207909|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
1207910|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
1207911|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
1207912|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
1207913|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
1207914|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
1207915|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
1207916|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
1207917|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
1207918|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
1207919|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
1207920|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
1207921|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
1207922|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
1207923|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
1207924|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
1207925|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
1207926|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
1207927|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
1207928|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
1207929|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
1207930|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
1207931|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
1207932|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
1207933|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
1207934|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
1207935|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
1207936|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
1207937|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
1207938|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
1207939|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
1207940|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
1207941|NCT00274456|E4|Reported Event|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
1207942|NCT00274456|E3|Reported Event|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
1207943|NCT00274456|E2|Reported Event|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
1207944|NCT00274456|E1|Reported Event|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
1207945|NCT00274287|B1|Baseline|GM-CSF (Leukine)|Once patients have finished receiving the chemotherapy and no signs of disease progression they may receive GMCSF (Leukine) as outlined in the protocol. 250 micro grams/m2 daily for two weeks followed by two weeks of rest.
1207946|NCT00274287|P1|Participant Flow|GM-CSF (Leukine)|Once patients have finished receiving the chemotherapy and no signs of disease progression they may receive GMCSF (Leukine) as outlined in the protocol. 250 micro grams/m2 daily for two weeks followed by two weeks of rest.
1207947|NCT00274287|O1|Outcome|GM-CSF (Leukine)|Taxotere is given at 75 mg/m2 on day 1 intravenously over 60 minutes with appropriate and standard pre-medications. Patients are eligible to receive growth factor support with G-CSF or Neulasta on day 2 at the investigator's discretion.
1207948|NCT00274287|E1|Reported Event|GM-CSF (Leukine)|Once patients have finished receiving the chemotherapy and no signs of disease progression they may receive GMCSF (Leukine) as outlined in the protocol. 250 micro grams/m2 daily for two weeks followed by two weeks of rest.
1207949|NCT00274261|B3|Baseline|Total|Total of all reporting groups
1207950|NCT00274261|B2|Baseline|Conceptrol|Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5mL volume of gel.
1207951|NCT00274261|B1|Baseline|C31G|C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel
1207952|NCT00274261|P2|Participant Flow|Conceptrol|Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5mL volume of gel.
1207953|NCT00274261|P1|Participant Flow|C31G|C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel
1207954|NCT00274261|O2|Outcome|Conceptrol|Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5mL volume of gel.
1207955|NCT00274261|O1|Outcome|C31G|C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel
1207956|NCT00274261|E2|Reported Event|Conceptrol|Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5mL volume of gel.
1207957|NCT00274261|E1|Reported Event|C31G|C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel
1207958|NCT00273910|B7|Baseline|Total|Total of all reporting groups
1207959|NCT00273910|B6|Baseline|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
1207960|NCT00273910|B5|Baseline|Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
1207961|NCT00273910|B4|Baseline|Adj-3 A2 gp209(2M) in Saline ID + Imiquimod|gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days.
1207962|NCT00273910|B3|Baseline|Adj-3 A2 gp209(2M) in Saline ID|gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
1207963|NCT00273910|B2|Baseline|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
1207964|NCT00273910|B1|Baseline|Adj-3 A2 gp209(2M) in IFA SQ (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
1207965|NCT00273910|P6|Participant Flow|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
1207966|NCT00273910|P5|Participant Flow|Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
1207967|NCT00273910|P4|Participant Flow|Adj-3 A2 gp209(2M) in Saline ID + Imiquimod|gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days.
1207968|NCT00273910|P3|Participant Flow|Adj-3 A2 gp209(2M) in Saline ID|gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
1207969|NCT00273910|P2|Participant Flow|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
1207970|NCT00273910|P1|Participant Flow|Adj-3 A2 gp209(2M) in IFA SQ (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
1208036|NCT00273754|O2|Outcome|Caffeine|Caffeine benzoate
1208037|NCT00273754|O1|Outcome|Placebo|Normal Saline
1208038|NCT00273754|O2|Outcome|Caffeine|Caffeine benzoate
1207971|NCT00273910|O6|Outcome|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
1207972|NCT00273910|O5|Outcome|Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
1207973|NCT00273910|O4|Outcome|Adj-3 A2 gp209(2M) in Saline ID + Imiquimod|gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days.
1207974|NCT00273910|O3|Outcome|Adj-3 A2 gp209(2M) in Saline ID|gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
1207975|NCT00273910|O2|Outcome|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
1207976|NCT00273910|O1|Outcome|Adj-3 A2 gp209(2M) in IFA SQ (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
1207977|NCT00273910|O6|Outcome|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
1207978|NCT00273910|O5|Outcome|Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
1207979|NCT00273910|O4|Outcome|Adj-3 A2 gp209(2M) in Saline ID + Imiquimod|gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days.
1207980|NCT00273910|O3|Outcome|Adj-3 A2 gp209(2M) in Saline ID|gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
1207981|NCT00273910|O2|Outcome|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
1207982|NCT00273910|O1|Outcome|Adj-3 A2 gp209(2M) in IFA SQ (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
1207983|NCT00273910|E6|Reported Event|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
1207984|NCT00273910|E5|Reported Event|Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
1207985|NCT00273910|E4|Reported Event|Adj-3 A2 gp209(2M) in Saline ID + Imiquimod|gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days.
1207986|NCT00273910|E3|Reported Event|Adj-3 A2 gp209(2M) in Saline ID|gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
1207987|NCT00273910|E2|Reported Event|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
1207988|NCT00273910|E1|Reported Event|Adj-3 A2 gp209(2M) in IFA SQ (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
1207989|NCT00273858|B1|Baseline|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
1207990|NCT00273858|P1|Participant Flow|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
1207991|NCT00273858|O1|Outcome|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
1207992|NCT00273858|O1|Outcome|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
1207993|NCT00273858|O1|Outcome|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
1207994|NCT00273858|O1|Outcome|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
1207995|NCT00273858|O1|Outcome|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
1207996|NCT00273858|O1|Outcome|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
1207997|NCT00273858|E1|Reported Event|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
1207998|NCT00273793|B7|Baseline|Total|Total of all reporting groups
1208039|NCT00273754|O1|Outcome|Placebo|Normal Saline
1208040|NCT00273754|O2|Outcome|Caffeine|Caffeine benzoate
1208041|NCT00273754|O1|Outcome|Placebo|Normal Saline
1207999|NCT00273793|B6|Baseline|Non Contingent Incentives Are Available to Smokers With Early|Non contingent incentives are available to Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that are non-contingently delivered on a random basis.
1208000|NCT00273793|B5|Baseline|Fixed Value Incentives Are Used in Smokers With Early Success|fixed value incentives are used in Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that are fixed in value
1208001|NCT00273793|B4|Baseline|Ascending Incentives Values Used in Smokers With Early Success|Ascending incentives values used in Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that escalate in value with each delivery.
1208002|NCT00273793|B3|Baseline|Non Contingent Incentives Available to Hard to Treat Smokers|Non contingent incentives available to hard to treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives non-contingently on a random basis.
1208003|NCT00273793|B2|Baseline|Fixed Criterion Intervention for Hard-to-treat Smokers|fixed criterion intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives for COs < 3 ppm.
1208004|NCT00273793|B1|Baseline|Shaping Intervention for Hard-to-treat Smokers|Shaping intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives based upon a percentile schedule.
1208005|NCT00273793|P6|Participant Flow|Non Contingent Incentives Are Available to Smokers With Early|Non contingent incentives are available to Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that are non-contingently delivered on a random basis.
1208006|NCT00273793|P5|Participant Flow|Fixed Value Incentives Are Used in Smokers With Early Success|fixed value incentives are used in Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that are fixed in value
1208007|NCT00273793|P4|Participant Flow|Ascending Incentives Values Used in Smokers With Early Success|Ascending incentives values used in Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that escalate in value with each delivery.
1208008|NCT00273793|P3|Participant Flow|Non Contingent Incentives Available to Hard to Treat Smokers|Non contingent incentives available to hard to treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives non-contingently on a random basis.
1208009|NCT00273793|P2|Participant Flow|Fixed Criterion Intervention for Hard-to-treat Smokers|fixed criterion intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives for COs < 3 ppm.
1208010|NCT00273793|P1|Participant Flow|Shaping Intervention for Hard-to-treat Smokers|Shaping intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives based upon a percentile schedule.
1208011|NCT00273793|O6|Outcome|Non Contingent Incentives Are Available to Smokers With Early|
1208012|NCT00273793|O5|Outcome|Fixed Value Incentives Are Used in Smokers With Early Success|
1208013|NCT00273793|O4|Outcome|Ascending Incentive Values Used in Smokers With Early Success|
1208014|NCT00273793|O3|Outcome|Non Contingent Incentives Available to Hard-to-Treat Smokers|
1208015|NCT00273793|O2|Outcome|Fixed Criterion Intervention for Hard-to-Treat Smokers|
1208016|NCT00273793|O1|Outcome|Shaping Intervention for Hard-to-Treat Smokers|
1208017|NCT00273793|O6|Outcome|Non Contingent Incentives Are Available to Smokers With Early|
1208018|NCT00273793|O5|Outcome|Fixed Value Incentives Are Used in Smokers With Early Success|
1208019|NCT00273793|O4|Outcome|Ascending Incentive Values Used in Smokers With Early Success|
1208020|NCT00273793|O3|Outcome|Non Contingent Incentives Available to Hard-to-Treat Smokers|
1208021|NCT00273793|O2|Outcome|Fixed Criterion Intervention for Hard-to-Treat Smokers|
1208022|NCT00273793|O1|Outcome|Shaping Intervention for Hard-to-Treat Smokers|
1208023|NCT00273793|E6|Reported Event|Non Contingent Incentives Are Available to Smokers With Early|Non contingent incentives are available to Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that are non-contingently delivered on a random basis.
1208453|NCT00272311|E3|Reported Event|Arm 3 of 5 Randomized Treatment Arms|325 mg Aspirin
1208024|NCT00273793|E5|Reported Event|Fixed Value Incentives Are Used in Smokers With Early Success|fixed value incentives are used in Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that are fixed in value
1208025|NCT00273793|E4|Reported Event|Ascending Incentives Values Used in Smokers With Early Success|Ascending incentives values used in Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that escalate in value with each delivery.
1208026|NCT00273793|E3|Reported Event|Non Contingent Incentives Available to Hard to Treat Smokers|Non contingent incentives available to hard to treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives non-contingently on a random basis.
1208027|NCT00273793|E2|Reported Event|Fixed Criterion Intervention for Hard-to-treat Smokers|fixed criterion intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives for COs < 3 ppm.
1208028|NCT00273793|E1|Reported Event|Shaping Intervention for Hard-to-treat Smokers|Shaping intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives based upon a percentile schedule.
1208029|NCT00273754|B3|Baseline|Total|Total of all reporting groups
1208030|NCT00273754|B2|Baseline|Caffeine|Caffeine benzoate
1208031|NCT00273754|B1|Baseline|Placebo|Normal Saline
1208032|NCT00273754|P2|Participant Flow|Caffeine|Caffeine benzoate
1208033|NCT00273754|P1|Participant Flow|Placebo|Normal Saline
1208047|NCT00273754|E1|Reported Event|Placebo|Normal Saline
1208048|NCT00273182|B1|Baseline|All Subjects|Patients implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
1208049|NCT00273182|P1|Participant Flow|All Subjects|Patients successfully implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
1208050|NCT00273182|O1|Outcome|All Subjects|Patients successfully implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
1208051|NCT00273182|O1|Outcome|All Subjects|Patients implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
1208052|NCT00273182|O1|Outcome|All Subjects|Patients implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
1208053|NCT00273182|O1|Outcome|All Subjects|Patients successfully implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
1208054|NCT00273182|O1|Outcome|All Subjects|Patients successfully implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
1208055|NCT00273182|E1|Reported Event|All Patients|The analysis included data from all subjects enrolled in the InSync Registry study.
1208056|NCT00273052|B3|Baseline|Total|Total of all reporting groups
1208057|NCT00273052|B2|Baseline|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
1208058|NCT00273052|B1|Baseline|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
1208059|NCT00273052|P2|Participant Flow|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
1208060|NCT00273052|P1|Participant Flow|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
1208061|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
1208062|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
1208063|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
1208064|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
1208065|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
1208066|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
1208067|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
1208068|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
1208069|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
1208070|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
1208071|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
1208072|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
1208073|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
1208074|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
1208075|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
1208076|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
1208077|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
1208078|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
1208079|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
1208080|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
1208081|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
1208082|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
1208083|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
1208084|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
1208085|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
1208086|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
1208087|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
1208563|NCT00271596|P2|Participant Flow|Placebo|Matching daily placebo
1208088|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
1208089|NCT00273052|E2|Reported Event|Toprol XL|Results include only treatment emergent events.
1208090|NCT00273052|E1|Reported Event|Coreg CR|Results include only treatment emergent events.
1208091|NCT00272987|B4|Baseline|Total|Total of all reporting groups
1208092|NCT00272987|B3|Baseline|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
1208093|NCT00272987|B2|Baseline|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
1208094|NCT00272987|B1|Baseline|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
1208095|NCT00272987|P3|Participant Flow|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
1208096|NCT00272987|P2|Participant Flow|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
1208097|NCT00272987|P1|Participant Flow|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
1208098|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
1208127|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
1208099|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
1208100|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
1208101|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
1208102|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
1208103|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
1208163|NCT00272961|P3|Participant Flow|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
1208104|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
1208105|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
1208106|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
1208107|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
1208108|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
1208109|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
1208110|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
1208111|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
1208112|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
1208180|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
1213500|NCT00255177|E3|Reported Event|VGX-410 300mg Daily|
1208113|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
1208114|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
1208115|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
1208116|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
1208164|NCT00272961|P2|Participant Flow|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
1208165|NCT00272961|P1|Participant Flow|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
1208117|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
1208118|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
1208119|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
1208120|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
1208121|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
1208122|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
1208123|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
1208124|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
1208125|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
1208126|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
1208428|NCT00272337|O2|Outcome|2 of 5 Randomized Treatment Arms|162 mg Aspirin
1208429|NCT00272337|O1|Outcome|1 of 5 Randomized Treatment Arms|81 mg Aspirin
1208128|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
1208129|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
1208130|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
1208131|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
1208132|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
1208133|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
1208134|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
1208135|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
1208136|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
1208137|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
1208138|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
1208139|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
1208140|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
1208141|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
1208430|NCT00272337|E5|Reported Event|5 of 5 Randomized Treatment Arms|1300 mg Aspirin
1208431|NCT00272337|E4|Reported Event|4 of 5 Randomized Treatment Arms|650 mg Aspirin
1208142|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
1208143|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
1208144|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
1208145|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
1208146|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
1208147|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
1208148|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
1208149|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
1208150|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
1208151|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
1208152|NCT00272987|E3|Reported Event|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
1208153|NCT00272987|E2|Reported Event|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
1208154|NCT00272987|E1|Reported Event|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
1208155|NCT00272961|B6|Baseline|Total|Total of all reporting groups
1208156|NCT00272961|B5|Baseline|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
1208432|NCT00272337|E3|Reported Event|3 of 5 Randomized Treatment Arms|325 mg Aspirin
1213501|NCT00255177|E2|Reported Event|VGX-410 150mg Daily|
1208157|NCT00272961|B4|Baseline|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
1208158|NCT00272961|B3|Baseline|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
1208159|NCT00272961|B2|Baseline|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
1208160|NCT00272961|B1|Baseline|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
1208161|NCT00272961|P5|Participant Flow|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
1208162|NCT00272961|P4|Participant Flow|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
1208166|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
1208167|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
1208168|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
1208169|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
1208170|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
1208171|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
1208172|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
1208173|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
1208174|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
1208175|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
1208176|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
1208177|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
1208178|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
1208179|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
1213502|NCT00255177|E1|Reported Event|Placebo|
1208181|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
1208182|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
1208183|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
1208184|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
1208185|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
1208186|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
1208187|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
1208188|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
1208189|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
1208190|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
1208191|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
1208192|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
1208193|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
1208194|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
1208195|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
1208196|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
1208197|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
1208198|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
1208199|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
1208200|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
1208201|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
1208202|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
1208433|NCT00272337|E2|Reported Event|2 of 5 Randomized Treatment Arms|162 mg Aspirin
1208203|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
1208204|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
1208205|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
1208206|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
1208207|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
1208208|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
1208209|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
1208210|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
1208211|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
1208212|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
1208213|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
1208214|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
1208215|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
1208216|NCT00272961|E5|Reported Event|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
1208217|NCT00272961|E4|Reported Event|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
1208218|NCT00272961|E3|Reported Event|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
1208219|NCT00272961|E2|Reported Event|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
1208220|NCT00272961|E1|Reported Event|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
1208221|NCT00272792|B3|Baseline|Total|Total of all reporting groups
1208222|NCT00272792|B2|Baseline|Placebo|Placebo, provided as tablets similar to Phenoptin tablets, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4 8 oz (120–240 mL) of water or apple juice. for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
1208223|NCT00272792|B1|Baseline|Sapropterin Dihydrochloride|Phenoptin, provided in tablets containing 100 mg of sapropterin dihydrochloride each, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4-8 oz (120–240 mL) of water or apple juice for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
1208224|NCT00272792|P2|Participant Flow|Placebo|Placebo, provided as tablets similar to Phenoptin tablets, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4 8 oz (120–240 mL) of water or apple juice. for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
1208225|NCT00272792|P1|Participant Flow|Sapropterin Dihydrochloride|Phenoptin, provided in tablets containing 100 mg of sapropterin dihydrochloride each, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4-8 oz (120–240 mL) of water or apple juice for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
1208434|NCT00272337|E1|Reported Event|1 of 5 Randomized Treatment Arms|81 mg Aspirin
1208435|NCT00272311|B6|Baseline|Total|Total of all reporting groups
1208226|NCT00272792|O2|Outcome|Placebo|Placebo, provided as tablets similar to Phenoptin tablets, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4 8 oz (120–240 mL) of water or apple juice. for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
1208227|NCT00272792|O1|Outcome|Sapropterin Dihydrochloride|Phenoptin, provided in tablets containing 100 mg of sapropterin dihydrochloride each, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4-8 oz (120–240 mL) of water or apple juice for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
1208228|NCT00272792|O2|Outcome|Placebo|Placebo, provided as tablets similar to Phenoptin tablets, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4 8 oz (120–240 mL) of water or apple juice. for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
1208229|NCT00272792|O1|Outcome|Sapropterin Dihydrochloride|Phenoptin, provided in tablets containing 100 mg of sapropterin dihydrochloride each, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4-8 oz (120–240 mL) of water or apple juice for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
1208230|NCT00272792|E2|Reported Event|Placebo|Placebo, provided as tablets similar to Phenoptin tablets, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4 8 oz (120–240 mL) of water or apple juice. for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
1208231|NCT00272792|E1|Reported Event|Sapropterin Dihydrochloride|Phenoptin, provided in tablets containing 100 mg of sapropterin dihydrochloride each, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4-8 oz (120–240 mL) of water or apple juice for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
1208232|NCT00272779|B3|Baseline|Total|Total of all reporting groups
1208484|NCT00271947|E1|Reported Event|Stem Cell Transplantation|stem cell transplantation : Autologous Hematopoietic Stem Cell Transplantation will be performed on all participants randomized to transplant arm.
1208485|NCT00271856|B3|Baseline|Total|Total of all reporting groups
1208233|NCT00272779|B2|Baseline|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208234|NCT00272779|B1|Baseline|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208235|NCT00272779|P2|Participant Flow|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208236|NCT00272779|P1|Participant Flow|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208237|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208238|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208239|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208240|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208241|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208242|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208243|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208244|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208245|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208246|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208247|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208248|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208249|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208250|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208251|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208486|NCT00271856|B2|Baseline|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
1208252|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208253|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208254|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208255|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208256|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208257|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208258|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208259|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208260|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208261|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208262|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208263|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208264|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208436|NCT00272311|B5|Baseline|Arm 5 of 5 Randomized Treatment Arms|1300 mg Aspirin
1208437|NCT00272311|B4|Baseline|Arm 4 of 5 Randomized Treatment Arms|650 mg Aspirin
1208265|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208266|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208267|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208268|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208269|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208270|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208271|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208272|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208273|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208274|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208275|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208276|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208277|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208278|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208279|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208280|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208281|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208282|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208283|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208438|NCT00272311|B3|Baseline|Arm 3 of 5 Randomized Treatment Arms|325 mg Aspirin
1208439|NCT00272311|B2|Baseline|Arm 2 of 5 Randomized Treatment Arms|162 mg Aspirin
1208284|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208285|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208286|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208287|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208288|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208289|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208290|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208291|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208292|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208293|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208294|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208295|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208296|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208297|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208298|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208299|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208300|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208301|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208302|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208440|NCT00272311|B1|Baseline|Arm 1 of 5 Randomized Treatment Arms|81 mg Aspirin
1208441|NCT00272311|P5|Participant Flow|Arm 5 of 5 Randomized Treatment Arms|1300 mg Aspirin
1208303|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208304|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208305|NCT00272779|O1|Outcome|All Participants With Pharmacogenetic Blood Samples|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208306|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208307|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208308|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208309|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208310|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208311|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208312|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208313|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208314|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208315|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208316|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208317|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208318|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208319|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208320|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208321|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208442|NCT00272311|P4|Participant Flow|Arm 4 of 5 Randomized Treatment Arms|650 mg Aspirin
1208443|NCT00272311|P3|Participant Flow|Arm 3 of 5 Randomized Treatment Arms|325 mg Aspirin
1208322|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208323|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208324|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208325|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208326|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208327|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208328|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208329|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208330|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208331|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208332|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208333|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208334|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208335|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208336|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208337|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208338|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208339|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208340|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208444|NCT00272311|P2|Participant Flow|Arm 2 of 5 Randomized Treatment Arms|162 mg Aspirin
1208445|NCT00272311|P1|Participant Flow|Arm 1 of 5 Randomized Treatment Arms|81 mg Aspirin
1208341|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208342|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208343|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208344|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208345|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208346|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208347|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208348|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208349|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208350|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208351|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208352|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208353|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208354|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208355|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208356|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208357|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208358|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208359|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208446|NCT00272311|O5|Outcome|Arm 5 of 5 Randomized Treatment Arms|1300 mg Aspirin
1208447|NCT00272311|O4|Outcome|Arm 4 of 5 Randomized Treatment Arms|650 mg Aspirin
1208360|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208361|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208362|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208363|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208364|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208365|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208366|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208367|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208368|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208369|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208370|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208371|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208372|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208373|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208374|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208375|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208376|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208377|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208378|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208448|NCT00272311|O3|Outcome|Arm 3 of 5 Randomized Treatment Arms|325 mg Aspirin
1208449|NCT00272311|O2|Outcome|Arm 2 of 5 Randomized Treatment Arms|162 mg Aspirin
1208379|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208380|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208381|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208382|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208383|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208384|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208385|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208386|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208387|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208388|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208389|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208390|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208391|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208392|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208393|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208394|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208395|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208396|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208397|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208450|NCT00272311|O1|Outcome|Arm 1 of 5 Randomized Treatment Arms|81 mg Aspirin
1208451|NCT00272311|E5|Reported Event|Arm 5 of 5 Randomized Treatment Arms|1300 mg Aspirin
1208398|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208399|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208400|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208401|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208402|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208403|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208404|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208405|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208406|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208407|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208408|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208409|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208410|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208411|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208412|NCT00272779|E2|Reported Event|LPV/RTV/Tenofovir/Emtricitabine|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
1208413|NCT00272779|E1|Reported Event|ATV/RTV/Tenofovir/Emtricitabine|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
1208414|NCT00272337|B6|Baseline|Total|Total of all reporting groups
1208415|NCT00272337|B5|Baseline|5 of 5 Randomized Treatment Arms|1300 mg Aspirin
1208416|NCT00272337|B4|Baseline|4 of 5 Randomized Treatment Arms|650 mg Aspirin
1208417|NCT00272337|B3|Baseline|3 of 5 Randomized Treatment Arms|325 mg Aspirin
1208418|NCT00272337|B2|Baseline|2 of 5 Randomized Treatment Arms|162 mg Aspirin
1208419|NCT00272337|B1|Baseline|1 of 5 Randomized Treatment Arms|81 mg Aspirin
1208420|NCT00272337|P5|Participant Flow|5 of 5 Randomized Treatment Arms|1300 mg Aspirin
1208421|NCT00272337|P4|Participant Flow|4 of 5 Randomized Treatment Arms|650 mg Aspirin
1208422|NCT00272337|P3|Participant Flow|3 of 5 Randomized Treatment Arms|325 mg Aspirin
1208423|NCT00272337|P2|Participant Flow|2 of 5 Randomized Treatment Arms|162 mg Aspirin
1208424|NCT00272337|P1|Participant Flow|1 of 5 Randomized Treatment Arms|81 mg Aspirin
1208425|NCT00272337|O5|Outcome|5 of 5 Randomized Treatment Arms|1300 mg Aspirin
1208426|NCT00272337|O4|Outcome|4 of 5 Randomized Treatment Arms|650 mg Aspirin
1208427|NCT00272337|O3|Outcome|3 of 5 Randomized Treatment Arms|325 mg Aspirin
1208454|NCT00272311|E2|Reported Event|Arm 2 of 5 Randomized Treatment Arms|162 mg Aspirin
1208455|NCT00272311|E1|Reported Event|Arm 1 of 5 Randomized Treatment Arms|81 mg Aspirin
1208456|NCT00272168|B3|Baseline|Total|Total of all reporting groups
1208457|NCT00272168|B2|Baseline|Arm 2: Control|"Supportive Treatment for SMI (control)~Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
1208458|NCT00272168|B1|Baseline|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)~Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
1208459|NCT00272168|P2|Participant Flow|Arm 2: Control|"Supportive Treatment for Serious Mental Illness (control)~Supportive Treatment for Serious Mental Illness (SMI): Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
1208460|NCT00272168|P1|Participant Flow|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)~Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
1208487|NCT00271856|B1|Baseline|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
1208461|NCT00272168|O2|Outcome|Arm 2: Control|"Supportive Treatment for SMI (control)~Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
1208462|NCT00272168|O1|Outcome|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)~Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
1208463|NCT00272168|O2|Outcome|Arm 2: Control|"Supportive Treatment for SMI (control)~Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
1208464|NCT00272168|O1|Outcome|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)~Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
1208465|NCT00272168|O2|Outcome|Arm 2: Control|"Supportive Treatment for SMI (control)~Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
1208466|NCT00272168|O1|Outcome|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)~Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
1208467|NCT00272168|O2|Outcome|Arm 2: Control|"Supportive Treatment for SMI (control)~Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
1208468|NCT00272168|O1|Outcome|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)~Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
1208469|NCT00272168|O2|Outcome|Arm 2: Control|"Supportive Treatment for SMI (control)~Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
1208470|NCT00272168|O1|Outcome|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)~Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
1208471|NCT00272168|O2|Outcome|Arm 2: Control|"Supportive Treatment for SMI (control)~Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
1208472|NCT00272168|O1|Outcome|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)~Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
1208473|NCT00272168|E2|Reported Event|Arm 2: Control|"Supportive Treatment for SMI (control)~Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
1208474|NCT00272168|E1|Reported Event|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)~Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
1208475|NCT00272038|B1|Baseline|Tarceva|Tarceva 150 mg QD
1208476|NCT00272038|P1|Participant Flow|Tarceva|Tarceva 150 mg orally every day
1208477|NCT00272038|O1|Outcome|Tarceva|Tarceva 150 mg QD
1208478|NCT00272038|O1|Outcome|Tarceva|Tarceva 150 mg QD
1208479|NCT00272038|O1|Outcome|Tarceva|Tarceva 150 mg QD
1208480|NCT00272038|E1|Reported Event|Tarceva|Tarceva 150 mg QD
1208481|NCT00271947|B1|Baseline|Stem Cell Transplantation|stem cell transplantation : Autologous Hematopoietic Stem Cell Transplantation will be performed on all participants randomized to transplant arm.
1208482|NCT00271947|P1|Participant Flow|Autologous Stem Cell Transplantation|stem cell transplantation : Autologous Hematopoietic Stem Cell Transplantation will be performed after conditioning regimen
1208483|NCT00271947|O1|Outcome|Stem Cell Transplantation|stem cell transplantation : Autologous Hematopoietic Stem Cell Transplantation will be performed on all participants randomized to transplant arm.
1208560|NCT00271596|B3|Baseline|Total|Total of all reporting groups
1208488|NCT00271856|P2|Participant Flow|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
1208489|NCT00271856|P1|Participant Flow|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
1208490|NCT00271856|O2|Outcome|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
1208491|NCT00271856|O1|Outcome|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
1208492|NCT00271856|O2|Outcome|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
1208493|NCT00271856|O1|Outcome|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
1208494|NCT00271856|O2|Outcome|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
1208495|NCT00271856|O1|Outcome|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
1208496|NCT00271856|O2|Outcome|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
1208497|NCT00271856|O1|Outcome|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
1208498|NCT00271856|O2|Outcome|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
1208499|NCT00271856|O1|Outcome|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
1208500|NCT00271856|O2|Outcome|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
1208501|NCT00271856|O1|Outcome|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
1208502|NCT00271856|E2|Reported Event|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
1208503|NCT00271856|E1|Reported Event|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
1208504|NCT00271817|B4|Baseline|Total|Total of all reporting groups
1208505|NCT00271817|B3|Baseline|Ezetimibe/Simvastatin + Niacin|"(Part 1): Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg as noted above) taken orally once daily for 24 weeks.~(Part 2): Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks."
1208506|NCT00271817|B2|Baseline|Ezetimibe/Simvastatin|"(Part 1): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks.~(Part 2): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks."
1208507|NCT00271817|B1|Baseline|Niacin|(Part 1): Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms started taking niacin 500 mg and had their niacin dose increased 500 mg every 4 weeks to 2000 mg.
1208508|NCT00271817|P3|Participant Flow|Ezetimibe/Simvastatin + Niacin|"(Part 1): Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg as noted above) taken orally once daily for 24 weeks.~(Part 2): Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks."
1208509|NCT00271817|P2|Participant Flow|Ezetimibe/Simvastatin|"(Part 1): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks.~(Part 2): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks."
1208510|NCT00271817|P1|Participant Flow|Niacin|(Part 1): Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms started taking niacin 500 mg and had their niacin dose increased 500 mg every 4 weeks to 2000 mg. Patients in this treatment group were ramdomly reassigned for Part 2 of the study to one of two treatment groups- two-thirds of the patients enrolled in the niacin treatment group were randomly assigned to receive ezetimibe/simvastatin + niacin (ER) and the other one-third were randomly assigned to receive ezetimibe/simvastatin alone.
1213503|NCT00255164|B4|Baseline|Total|Total of all reporting groups
1208511|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
1208512|NCT00271817|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks.
1208513|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
1208514|NCT00271817|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks.
1208515|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
1208516|NCT00271817|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
1208517|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
1208518|NCT00271817|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
1208519|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
1208520|NCT00271817|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
1208521|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
1208561|NCT00271596|B2|Baseline|Placebo|Matching daily placebo
1208562|NCT00271596|B1|Baseline|Citalopram|20mg daily citalopram
1208522|NCT00271817|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
1208523|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
1208524|NCT00271817|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks.
1208525|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
1208526|NCT00271817|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks.
1208527|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
1208528|NCT00271817|O1|Outcome|Niacin|Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms had their niacin titrated (increased 500 mg every 4 weeks to 2000 mg).
1208529|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
1208530|NCT00271817|O1|Outcome|Niacin|Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms had their niacin titrated (increased 500 mg every 4 weeks to 2000 mg).
1208531|NCT00271817|E5|Reported Event|Ezetimibe/Simvastatin + Niacin - Part 2|Ezetimibe/Simvastatin + Niacin group from Part 2 All-Treated Patient as Treated Population
1208532|NCT00271817|E4|Reported Event|Ezetimibe/Simvastatin - Part 2|EZ/Simva group from Part 2 All-Treated Patient as Treated Population
1208533|NCT00271817|E3|Reported Event|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin + Niacin group from Part 1
1208534|NCT00271817|E2|Reported Event|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin group from Part 1
1208535|NCT00271817|E1|Reported Event|Niacin|Niacin group from Part 1
1208536|NCT00271739|B3|Baseline|Total|Total of all reporting groups
1208537|NCT00271739|B2|Baseline|Usual Care|Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant’s Primary Care Provider.
1208538|NCT00271739|B1|Baseline|Telemedicine Case Management|Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.
1208539|NCT00271739|P2|Participant Flow|Usual Care|Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant’s Primary Care Provider.
1208540|NCT00271739|P1|Participant Flow|Telemedicine Case Management|Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.
1208541|NCT00271739|O2|Outcome|Usual Care|Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant’s Primary Care Provider.
1208542|NCT00271739|O1|Outcome|Telemedicine Case Management|Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.
1208543|NCT00271739|O2|Outcome|Usual Care|Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant’s Primary Care Provider.
1208544|NCT00271739|O1|Outcome|Telemedicine Case Management|Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.
1208545|NCT00271739|O2|Outcome|Usual Care|Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant’s Primary Care Provider.
1208611|NCT00271544|O1|Outcome|4196 Lead|Subjects successfully implanted with a Model 4196 lead
1208546|NCT00271739|O1|Outcome|Telemedicine Case Management|Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.
1208547|NCT00271739|E2|Reported Event|Usual Care|Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant’s Primary Care Provider.
1208548|NCT00271739|E1|Reported Event|Telemedicine Case Management|Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.
1208549|NCT00271609|B3|Baseline|Total|Total of all reporting groups
1208550|NCT00271609|B2|Baseline|Glioblastoma Multiforme (GBM)|Glioblastoma multiforme Gliosarcoma
1208551|NCT00271609|B1|Baseline|Anaplastic Glioma (AG)|Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified)
1208552|NCT00271609|P2|Participant Flow|Anaplastic Glioma (AG)|Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified)
1208553|NCT00271609|P1|Participant Flow|Glioblastoma Multiforme (GBM)|Glioblastoma multiforme Gliosarcoma
1208554|NCT00271609|O2|Outcome|Glioblastoma Multiforme (GBM)|Glioblastoma multiforme Gliosarcoma
1208555|NCT00271609|O1|Outcome|Anaplastic Glioma (AG)|Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified)
1208556|NCT00271609|O2|Outcome|Glioblastoma Multiforme (GBM)|Glioblastoma multiforme Gliosarcoma
1208557|NCT00271609|O1|Outcome|Anaplastic Glioma (AG)|Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified)
1208558|NCT00271609|E2|Reported Event|Glioblastoma Multiforme (GBM)|Glioblastoma multiforme Gliosarcoma
1208559|NCT00271609|E1|Reported Event|Anaplastic Glioma (AG)|Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified)
1208564|NCT00271596|P1|Participant Flow|Citalopram|20mg daily citalopram
1208565|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
1208566|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
1208567|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
1208568|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
1208569|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
1208570|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
1208571|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
1208572|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
1208573|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
1208574|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
1208575|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
1208576|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
1208577|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
1208578|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
1208579|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
1208580|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
1208581|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
1208582|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
1208583|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
1208584|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
1208585|NCT00271596|E2|Reported Event|Placebo|Matching daily placebo
1208586|NCT00271596|E1|Reported Event|Citalopram|20mg daily citalopram
1208587|NCT00271570|B3|Baseline|Total|Total of all reporting groups
1208588|NCT00271570|B2|Baseline|Infliximab (5mg/kg)|Remicade (Infliximab Arm of 5mg/kg)
1208589|NCT00271570|B1|Baseline|IVIG Arm (2 gr/kg)|2nd dose of IVIG (2gr/kg)
1208590|NCT00271570|P2|Participant Flow|Infliximab (5mg/kg)|Remicade (Infliximab Arm of 5mg/kg)
1208591|NCT00271570|P1|Participant Flow|IVIG Arm (2 gr/kg)|2nd dose of IVIG (2gr/kg)
1208592|NCT00271570|O2|Outcome|Infliximab (5mg/kg)|Remicade (Infliximab Arm of 5mg/kg)
1208593|NCT00271570|O1|Outcome|IVIG Arm (2 gr/kg)|2nd dose of IVIG (2gr/kg)
1208594|NCT00271570|O2|Outcome|Infliximab (5mg/kg)|Remicade (Infliximab Arm of 5mg/kg)
1208595|NCT00271570|O1|Outcome|IVIG Arm (2 gr/kg)|2nd dose of IVIG (2gr/kg)
1208596|NCT00271570|E2|Reported Event|Infliximab (5mg/kg)|Remicade (Infliximab Arm of 5mg/kg)
1208597|NCT00271570|E1|Reported Event|IVIG Arm (2 gr/kg)|2nd dose of IVIG (2gr/kg)
1208598|NCT00271544|B1|Baseline|4196 Lead|Subjects underwent Model 4196 left ventricular lead implant attempt
1208599|NCT00271544|P1|Participant Flow|4196 Lead|Subjects underwent Model 4196 left ventricular lead implant attempt
1208600|NCT00271544|O1|Outcome|4196 Lead|All enrolled subjects
1208601|NCT00271544|O1|Outcome|4196 Lead|Subjects with ring electrode pacing impedance at 12-month
1208602|NCT00271544|O1|Outcome|4196 Lead|Subjects with ring electrode threshold captured at 0.5ms at 12-month
1208603|NCT00271544|O1|Outcome|4196 Lead|Subjects with ring electrode R-wave amplitude at implant
1208604|NCT00271544|O1|Outcome|4196 Lead|Subjects with tip electrode pacing impedance at 12-month
1208605|NCT00271544|O1|Outcome|4196 Lead|Subjects with tip electrode threshold captured at 0.5ms at 12-month
1208606|NCT00271544|O1|Outcome|4196 Lead|Subjects with tip electrode R-wave amplitude at 12-month
1208607|NCT00271544|O1|Outcome|4196 Lead|Subjects who underwent Model 4196 left ventricular lead implant attempt
1208608|NCT00271544|O1|Outcome|4196 Lead|Subjects successfully implanted with a Model 4196 lead
1208609|NCT00271544|O1|Outcome|4196 Lead|Subjects successfully implanted with a Model 4196 lead
1208610|NCT00271544|O1|Outcome|4196 Lead|Subjects successfully implanted with a Model 4196 lead
1208612|NCT00271544|O1|Outcome|4196 Lead|Subjects who underwent an implant attempt
1208613|NCT00271544|O1|Outcome|4196 Lead|Subjects who underwent an implant attempt
1208614|NCT00271544|O1|Outcome|4196 Lead|Subjects who underwent an implant attempt with successful CS cannulation
1208615|NCT00271544|O1|Outcome|4196 Lead|Subjects with ring electrode threshold captured at 0.5ms at 3-month
1208616|NCT00271544|O1|Outcome|4196 Lead|Subjects with tip electrode threshold capture at 0.5ms at 1-month
1208617|NCT00271544|O1|Outcome|4196 Lead|Subjects who underwent Model 4196 LV lead implant attempt
1208618|NCT00271544|O1|Outcome|4196 Lead|Subjects who underwent Model 4196 left ventricular lead implant attempt
1208619|NCT00271375|B4|Baseline|Total|Total of all reporting groups
1208620|NCT00271375|B3|Baseline|Control Group Usual Care|Control: Control group usual care
1208621|NCT00271375|B2|Baseline|Caring for You, Caring for me + Social Worker (Educational Int|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
1208622|NCT00271375|B1|Baseline|Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
1208623|NCT00271375|P3|Participant Flow|Control Group Usual Care|Control: Control group usual care
1208624|NCT00271375|P2|Participant Flow|Caring for You, Caring for me + Social Worker (Educational Int|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
1208625|NCT00271375|P1|Participant Flow|Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
1208626|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
1208627|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
1208628|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
1208629|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
1208673|NCT00271219|O2|Outcome|B Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
1208630|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
1208631|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
1208632|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
1208633|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
1208634|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
1208635|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
1208636|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
1208637|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
1208638|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
1208639|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
1208640|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
1208641|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
1208642|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
1208643|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
1208644|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
1208645|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
1208646|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
1208647|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
1208648|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
1208649|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
1208650|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
1208651|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
1208652|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
1208653|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
1208711|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
1208712|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
1208654|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
1208655|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
1208656|NCT00271375|O1|Outcome|Overall Evaluation|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
1208657|NCT00271375|E3|Reported Event|Arm 3: Control Group Usual Care|Control: Control group usual care
1208658|NCT00271375|E2|Reported Event|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
1208659|NCT00271375|E1|Reported Event|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
1208660|NCT00271219|B3|Baseline|Total|Total of all reporting groups
1208661|NCT00271219|B2|Baseline|Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
1208662|NCT00271219|B1|Baseline|Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
1208663|NCT00271219|P2|Participant Flow|Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
1208664|NCT00271219|P1|Participant Flow|Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
1208665|NCT00271219|O2|Outcome|Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
1208666|NCT00271219|O1|Outcome|Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
1208667|NCT00271219|O2|Outcome|B Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
1208668|NCT00271219|O1|Outcome|A Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
1208669|NCT00271219|O2|Outcome|B Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
1208670|NCT00271219|O1|Outcome|A Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
1208671|NCT00271219|O2|Outcome|B Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
1208672|NCT00271219|O1|Outcome|A Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
1208674|NCT00271219|O1|Outcome|A Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
1208675|NCT00271219|O2|Outcome|B Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
1208676|NCT00271219|O1|Outcome|A Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
1208677|NCT00271219|O2|Outcome|B Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
1208678|NCT00271219|O1|Outcome|A Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
1208679|NCT00271219|O2|Outcome|B Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
1208680|NCT00271219|O1|Outcome|A Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
1208681|NCT00271219|O2|Outcome|B Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
1208682|NCT00271219|O1|Outcome|A Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
1208683|NCT00271219|E4|Reported Event|Buprenorphine: Neonates|Neonates born to mothers maintained on buprenorphine
1208684|NCT00271219|E3|Reported Event|Methadone: Neonates|Neonates born to mothers maintained on methadone
1208685|NCT00271219|E2|Reported Event|Buprenorphine: Mothers|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
1208686|NCT00271219|E1|Reported Event|Methadone: Mothers|"Methadone~Methadone : daily oral dosing 20-140 mg"
1208687|NCT00271154|B3|Baseline|Total|Total of all reporting groups
1208688|NCT00271154|B2|Baseline|CRT ON|Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
1208689|NCT00271154|B1|Baseline|CRT OFF|Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
1208690|NCT00271154|P2|Participant Flow|CRT ON|Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
1208691|NCT00271154|P1|Participant Flow|CRT OFF|Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
1208692|NCT00271154|O2|Outcome|CRT ON|Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
1208693|NCT00271154|O1|Outcome|CRT OFF|Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
1208694|NCT00271154|O2|Outcome|CRT ON|Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
1208695|NCT00271154|O1|Outcome|CRT OFF|Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
1208696|NCT00271154|E3|Reported Event|Not Randomized|These patients were enrolled in the study, but not randomized to CRT ON or CRT OFF. Their adverse events were collected until they exited the study.
1208697|NCT00271154|E2|Reported Event|CRT ON|Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
1208698|NCT00271154|E1|Reported Event|CRT OFF|Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
1208699|NCT00271024|B5|Baseline|Total|Total of all reporting groups
1208700|NCT00271024|B4|Baseline|Placebo - FEMALE|Females receiving placebo as part of the trial
1208701|NCT00271024|B3|Baseline|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
1208702|NCT00271024|B2|Baseline|Placebo - MALE|Males receiving placebo as part of the trial
1208703|NCT00271024|B1|Baseline|Naltrexone - MALE|Males receiving naltrexone as part of the trial
1208704|NCT00271024|P4|Participant Flow|Placebo - FEMALE|Females receiving placebo as part of the trial
1208705|NCT00271024|P3|Participant Flow|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
1208706|NCT00271024|P2|Participant Flow|Placebo - MALE|Males receiving placebo as part of the trial
1208707|NCT00271024|P1|Participant Flow|Naltrexone - MALE|Males receiving naltrexone as part of the trial
1208708|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
1208709|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
1208710|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
1208713|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
1208714|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
1208715|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
1208716|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
1208717|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
1208718|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
1208719|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
1208720|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
1208721|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
1208722|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
1208723|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
1208724|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
1208725|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
1208726|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
1208727|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
1208728|NCT00271024|O2|Outcome|Naltrexone|Participants receiving Naltrexone as part of the trial
1208729|NCT00271024|O1|Outcome|Placebo|Participants receiving Placebo as part of the trial
1208730|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
1208731|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
1208732|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
1208733|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
1208734|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
1208735|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
1208736|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
1208737|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
1208738|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
1208739|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
1208740|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
1208741|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
1208742|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
1208743|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
1208744|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
1208745|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
1208746|NCT00271024|E2|Reported Event|Naltrexone|Participants receiving Naltrexone as part of the trial
1208747|NCT00271024|E1|Reported Event|Placebo|Participants receiving Placebo as part of the trial
1208748|NCT00271011|B1|Baseline|Mitomycin C, Irinotecan and Cetuximab|"Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.~Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle.~Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1*28 allele will receive irinotecan 110 mg/m2."
1208749|NCT00271011|P1|Participant Flow|Mitomycin C, Irinotecan and Cetuximab|"Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.~Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle.~Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1*28 allele will receive irinotecan 110 mg/m2."
1208750|NCT00271011|O1|Outcome|Mitomycin C, Irinotecan and Cetuximab|"Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.~Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle.~Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1*28 allele will receive irinotecan 110 mg/m2."
1208751|NCT00271011|O1|Outcome|Mitomycin C, Irinotecan and Cetuximab|"Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.~Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle.~Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1*28 allele will receive irinotecan 110 mg/m2."
1208752|NCT00271011|E1|Reported Event|Mitomycin C, Irinotecan and Cetuximab|"Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.~Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle.~Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1*28 allele will receive irinotecan 110 mg/m2."
1208753|NCT00270894|B1|Baseline|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
1208820|NCT00270634|O1|Outcome|High Dose Voclosporin|Starting dose of 0.8 mg/kg
1208821|NCT00270634|E4|Reported Event|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
1208754|NCT00270894|P1|Participant Flow|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
1208755|NCT00270894|O1|Outcome|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
1208756|NCT00270894|O1|Outcome|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
1208757|NCT00270894|O1|Outcome|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
1208758|NCT00270894|O1|Outcome|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
1208759|NCT00270894|O1|Outcome|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
1208760|NCT00270894|O1|Outcome|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
1209413|NCT00267098|P2|Participant Flow|Unsuccessful Implants|Subjects who underwent an implant attempt of a CRT-P or CRT-D device but were not successfully implanted
1208761|NCT00270894|O1|Outcome|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
1208762|NCT00270894|E1|Reported Event|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
1208763|NCT00270842|B4|Baseline|Total|Total of all reporting groups
1208764|NCT00270842|B3|Baseline|Tai Chi|"Exercise Group that participated in tai chi training classes~Tai Chi: This intervention is a 10 week Tai Chi group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
1208765|NCT00270842|B2|Baseline|Functional Balance Training|"Exercise group that participated in functional balance training~Functional Balance: This intervention is a 10 week Functional Balance group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
1208766|NCT00270842|B1|Baseline|Education Control Group|"Education group that is the control group for the study. Is a 10 week course with diverse health education topics.~Education Control group: This control group participated in 10 weeks of general health education classes."
1208767|NCT00270842|P3|Participant Flow|Tai Chi|"Exercise Group that participated in tai chi training classes~Tai Chi: This intervention is a 10 week Tai Chi group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
1208768|NCT00270842|P2|Participant Flow|Functional Balance Training|"Exercise group that participated in functional balance training~Functional Balance: This intervention is a 10 week Functional Balance group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
1208769|NCT00270842|P1|Participant Flow|Education Control Group|"Education group that is the control group for the study. Is a 10 week course with diverse health education topics.~Education Control group: This control group participated in 10 weeks of general health education classes."
1208770|NCT00270842|O3|Outcome|Tai Chi|"Exercise Group that participated in tai chi training classes~Tai Chi: This intervention is a 10 week Tai Chi group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
1208771|NCT00270842|O2|Outcome|Functional Balance Training|"Exercise group that participated in functional balance training~Functional Balance: This intervention is a 10 week Functional Balance group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
1208772|NCT00270842|O1|Outcome|Education Control Group|"Education group that is the control group for the study. Is a 10 week course with diverse health education topics.~Education Control group: This control group participated in 10 weeks of general health education classes."
1208773|NCT00270842|O3|Outcome|Tai Chi|"Exercise Group that participated in tai chi training classes~Tai Chi: This intervention is a 10 week Tai Chi group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
1208774|NCT00270842|O2|Outcome|Functional Balance Training|"Exercise group that participated in functional balance training~Functional Balance: This intervention is a 10 week Functional Balance group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
1208775|NCT00270842|O1|Outcome|Education Control Group|"Education group that is the control group for the study. Is a 10 week course with diverse health education topics.~Education Control group: This control group participated in 10 weeks of general health education classes."
1208776|NCT00270842|E3|Reported Event|Tai Chi|"Exercise Group that participated in tai chi training classes~Tai Chi: This intervention is a 10 week Tai Chi group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
1208822|NCT00270634|E3|Reported Event|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
1208823|NCT00270634|E2|Reported Event|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
1208777|NCT00270842|E2|Reported Event|Functional Balance Training|"Exercise group that participated in functional balance training~Functional Balance: This intervention is a 10 week Functional Balance group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
1208778|NCT00270842|E1|Reported Event|Education Control Group|"Education group that is the control group for the study. Is a 10 week course with diverse health education topics.~Education Control group: This control group participated in 10 weeks of general health education classes."
1208779|NCT00270790|B1|Baseline|AMIFOSTINE +CARBOPLATIN, TAXOL +RT|"EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.~Amifostine: Amifostine will be given at dose of 500 mg IV within one hour before radiation~Carboplatin: Carboplatin for 100 mg/m2~Taxol: Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose~Radiotherapy: Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy"
1208780|NCT00270790|P1|Participant Flow|AMIFOSTINE +2 Chemo Lines +RT|"EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.~Amifostine: Amifostine will be given at dose of 500 mg IV within one hour before radiation~Carboplatin: Carboplatin for 100 mg/m2~Taxol: Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose~Radiotherapy: Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy"
1208781|NCT00270790|O1|Outcome|AMIFOSTINE +CARBOPLATIN, TAXOL +RT|"EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.~Amifostine: Amifostine will be given at dose of 500 mg IV within one hour before radiation~Carboplatin: Carboplatin for 100 mg/m2~Taxol: Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose~Radiotherapy: Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy"
1208782|NCT00270790|O1|Outcome|AMIFOSTINE +CARBOPLATIN, TAXOL +RT|"EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.~Amifostine: Amifostine will be given at dose of 500 mg IV within one hour before radiation~Carboplatin: Carboplatin for 100 mg/m2~Taxol: Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose~Radiotherapy: Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy"
1208783|NCT00270790|E1|Reported Event|AMIFOSTINE +CARBOPLATIN, TAXOL +RT|"EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.~Amifostine: Amifostine will be given at dose of 500 mg IV within one hour before radiation~Carboplatin: Carboplatin for 100 mg/m2~Taxol: Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose~Radiotherapy: Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy"
1208784|NCT00270634|B5|Baseline|Total|Total of all reporting groups
1208785|NCT00270634|B4|Baseline|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
1208786|NCT00270634|B3|Baseline|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
1208787|NCT00270634|B2|Baseline|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
1208788|NCT00270634|B1|Baseline|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
1208789|NCT00270634|P4|Participant Flow|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
1208790|NCT00270634|P3|Participant Flow|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
1208791|NCT00270634|P2|Participant Flow|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
1208792|NCT00270634|P1|Participant Flow|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
1208793|NCT00270634|O4|Outcome|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
1208794|NCT00270634|O3|Outcome|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
1208795|NCT00270634|O2|Outcome|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
1208796|NCT00270634|O1|Outcome|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
1208797|NCT00270634|O4|Outcome|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
1208798|NCT00270634|O3|Outcome|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
1208799|NCT00270634|O2|Outcome|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
1208800|NCT00270634|O1|Outcome|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
1208801|NCT00270634|O4|Outcome|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
1208802|NCT00270634|O3|Outcome|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
1208803|NCT00270634|O2|Outcome|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
1208804|NCT00270634|O1|Outcome|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
1208805|NCT00270634|O4|Outcome|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
1208806|NCT00270634|O3|Outcome|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
1208807|NCT00270634|O2|Outcome|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
1208808|NCT00270634|O1|Outcome|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
1208809|NCT00270634|O4|Outcome|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
1208810|NCT00270634|O3|Outcome|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
1208811|NCT00270634|O2|Outcome|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
1208812|NCT00270634|O1|Outcome|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
1208813|NCT00270634|O4|Outcome|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
1208814|NCT00270634|O3|Outcome|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
1208815|NCT00270634|O2|Outcome|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
1208816|NCT00270634|O1|Outcome|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
1208817|NCT00270634|O4|Outcome|Tacrolimus|Standard dose
1208818|NCT00270634|O3|Outcome|Low Dose Voclosporin|Starting dose of 0.4 mg/kg
1208819|NCT00270634|O2|Outcome|Mid Dose Voclosporin|Starting dose of 0.6 mg/kg
1208824|NCT00270634|E1|Reported Event|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
1208825|NCT00270296|B4|Baseline|Total|Total of all reporting groups
1208826|NCT00270296|B3|Baseline|NVP Arm|"Participants in Arm 2 will have CD4 counts less than 200 cells/mm3 and will receive NVP once daily for the first 14 days, then twice daily, and 3TC/ZDV twice daily; these women will be in the observational group.~Nevirapine: 200 mg tablet taken orally daily for the first 14 days before receiving 200 mg tablet taken orally twice daily"
1208827|NCT00270296|B2|Baseline|Kaletra Arm|"Participants in Arm 1B will have CD4 counts of 200 cells/mm3 or more and will receive LPV/RTV and 3TC/ZDV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.~Lamivudine/Zidovudine: 150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily~Lopinavir/Ritonavir: 400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily"
1208828|NCT00270296|B1|Baseline|TZV Arm|"Participants in Arm 1A will have CD4 counts of 200 cells/mm3 or more and will receive TZV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.~Trizivir: 300 mg abacavir sulfate/150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily"
1208829|NCT00270296|P3|Participant Flow|NVP Arm|"Participants in Arm 2 will have CD4 counts less than 200 cells/mm3 and will receive NVP once daily for the first 14 days, then twice daily, and 3TC/ZDV twice daily; these women will be in the observational group.~Nevirapine: 200 mg tablet taken orally daily for the first 14 days before receiving 200 mg tablet taken orally twice daily"
1208830|NCT00270296|P2|Participant Flow|Kaletra Arm|"Participants in Arm 1B will have CD4 counts of 200 cells/mm3 or more and will receive LPV/RTV and 3TC/ZDV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.~Lamivudine/Zidovudine: 150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily~Lopinavir/Ritonavir: 400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily"
1208831|NCT00270296|P1|Participant Flow|TZV Arm|"Participants in Arm 1A will have CD4 counts of 200 cells/mm3 or more and will receive TZV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.~Trizivir: 300 mg abacavir sulfate/150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily"
1209605|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
1208832|NCT00270296|O3|Outcome|NVP Arm|"Participants in Arm 2 will have CD4 counts less than 200 cells/mm3 and will receive NVP once daily for the first 14 days, then twice daily, and 3TC/ZDV twice daily; these women will be in the observational group.~Nevirapine: 200 mg tablet taken orally daily for the first 14 days before receiving 200 mg tablet taken orally twice daily"
1208833|NCT00270296|O2|Outcome|Kaletra Arm|"Participants in Arm 1B will have CD4 counts of 200 cells/mm3 or more and will receive LPV/RTV and 3TC/ZDV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.~Lamivudine/Zidovudine: 150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily~Lopinavir/Ritonavir: 400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily"
1208834|NCT00270296|O1|Outcome|TZV Arm|"Participants in Arm 1A will have CD4 counts of 200 cells/mm3 or more and will receive TZV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.~Trizivir: 300 mg abacavir sulfate/150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily"
1208835|NCT00270296|O3|Outcome|NVP Arm|"Participants in Arm 2 will have CD4 counts less than 200 cells/mm3 and will receive NVP once daily for the first 14 days, then twice daily, and 3TC/ZDV twice daily; these women will be in the observational group.~Nevirapine: 200 mg tablet taken orally daily for the first 14 days before receiving 200 mg tablet taken orally twice daily"
1208836|NCT00270296|O2|Outcome|Kaletra Arm|"Participants in Arm 1B will have CD4 counts of 200 cells/mm3 or more and will receive LPV/RTV and 3TC/ZDV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.~Lamivudine/Zidovudine: 150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily~Lopinavir/Ritonavir: 400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily"
1208837|NCT00270296|O1|Outcome|TZV Arm|"Participants in Arm 1A will have CD4 counts of 200 cells/mm3 or more and will receive TZV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.~Trizivir: 300 mg abacavir sulfate/150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily"
1208838|NCT00270296|E3|Reported Event|NVP Arm|"Participants in Arm 2 will have CD4 counts less than 200 cells/mm3 and will receive NVP once daily for the first 14 days, then twice daily, and 3TC/ZDV twice daily; these women will be in the observational group.~Nevirapine: 200 mg tablet taken orally daily for the first 14 days before receiving 200 mg tablet taken orally twice daily"
1208839|NCT00270296|E2|Reported Event|Kaletra Arm|"Participants in Arm 1B will have CD4 counts of 200 cells/mm3 or more and will receive LPV/RTV and 3TC/ZDV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.~Lamivudine/Zidovudine: 150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily~Lopinavir/Ritonavir: 400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily"
1208840|NCT00270296|E1|Reported Event|TZV Arm|"Participants in Arm 1A will have CD4 counts of 200 cells/mm3 or more and will receive TZV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.~Trizivir: 300 mg abacavir sulfate/150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily"
1208841|NCT00270257|B3|Baseline|Total|Total of all reporting groups
1208842|NCT00270257|B2|Baseline|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.~Buprenorphine/Naloxone: Oral tablet"
1208843|NCT00270257|B1|Baseline|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52~Buprenorphine/Naloxone: Oral tablet"
1208844|NCT00270257|P2|Participant Flow|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.~Buprenorphine/Naloxone: Oral tablet"
1209453|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1208845|NCT00270257|P1|Participant Flow|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52~Buprenorphine/Naloxone: Oral tablet"
1208846|NCT00270257|O2|Outcome|Thailand|Long Term and Short arms were compared
1208847|NCT00270257|O1|Outcome|China|Long Term and Short arms were compared
1208848|NCT00270257|O2|Outcome|Thailand|Long Term and Short arms were compared
1208849|NCT00270257|O1|Outcome|China|Long Term and Short arms were compared
1208850|NCT00270257|O2|Outcome|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.~Buprenorphine/Naloxone: Oral tablet"
1208851|NCT00270257|O1|Outcome|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52~Buprenorphine/Naloxone: Oral tablet"
1208852|NCT00270257|O2|Outcome|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.~Buprenorphine/Naloxone: Oral tablet"
1208853|NCT00270257|O1|Outcome|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52~Buprenorphine/Naloxone: Oral tablet"
1208901|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
1208854|NCT00270257|O2|Outcome|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.~Buprenorphine/Naloxone: Oral tablet"
1208855|NCT00270257|O1|Outcome|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52~Buprenorphine/Naloxone: Oral tablet"
1208856|NCT00270257|O2|Outcome|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.~Buprenorphine/Naloxone: Oral tablet"
1208857|NCT00270257|O1|Outcome|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52~Buprenorphine/Naloxone: Oral tablet"
1208858|NCT00270257|O2|Outcome|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.~Buprenorphine/Naloxone: Oral tablet"
1208859|NCT00270257|O1|Outcome|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52~Buprenorphine/Naloxone: Oral tablet"
1208860|NCT00270257|E2|Reported Event|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.~Buprenorphine/Naloxone: Oral tablet"
1208861|NCT00270257|E1|Reported Event|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52~Buprenorphine/Naloxone: Oral tablet"
1208862|NCT00270231|B1|Baseline|Entire Study Population|Includes subjects with both OPRM1 genotypes (Asp40 (A/G or G/G allele vs. Asn40 (A/A) allele) who started Intervention Period 1.
1208863|NCT00270231|P2|Participant Flow|Placebo, Then Naltrexone|"These participants took placebo (sugar pill) during their first 4-day study period.~They received active naltrexone during the second 4-day study period. The dosing for naltrexone was the same for all participants. Day 1 = 12.5mg, Day 2 = 25mg, Days 3 & 4 = 50mg."
1208864|NCT00270231|P1|Participant Flow|Naltrexone, Then Placebo|"These participants took active naltrexone during their first 4-day study period. The dosing for naltrexone was the same for all participants. Day 1 = 12.5mg, Day 2 = 25mg, Days 3 & 4 = 50mg.~They received placebo (sugar pill) during the second 4-day study period."
1208865|NCT00270231|O2|Outcome|OPRM1 Genotype - A/G or G/G|Participants who have the Asp40 OPRM1=A/G or G/G
1208866|NCT00270231|O1|Outcome|OPRM1 Genotype - A/A|Participants who have the Asn40 OPRM1=A/A
1208867|NCT00270231|E2|Reported Event|Placebo Only|Placebo (sugar pill) recipients (taken for four days).
1208868|NCT00270231|E1|Reported Event|Naltrexone Only|Active medication recipients (Naltrexone taken for 4 days).
1208869|NCT00270205|B5|Baseline|Total|Total of all reporting groups
1208870|NCT00270205|B4|Baseline|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
1208871|NCT00270205|B3|Baseline|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
1208918|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
1208872|NCT00270205|B2|Baseline|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
1208873|NCT00270205|B1|Baseline|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
1208874|NCT00270205|P4|Participant Flow|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
1208875|NCT00270205|P3|Participant Flow|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
1208876|NCT00270205|P2|Participant Flow|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
1208877|NCT00270205|P1|Participant Flow|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
1208878|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
1212371|NCT00260429|B3|Baseline|Total|Total of all reporting groups
1208879|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
1208880|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
1208881|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
1208882|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
1208883|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
1208884|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
1208885|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
1208886|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
1208887|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
1208888|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
1208889|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
1208890|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
1208891|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
1208892|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
1208893|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
1208894|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
1208942|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
1214045|NCT00252967|O2|Outcome|Atorvastatin|
1208895|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
1208896|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
1208897|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
1208898|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
1208899|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
1208900|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
1208902|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
1208903|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
1208904|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
1208905|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
1208906|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
1208907|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
1208908|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
1208909|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
1208910|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
1208911|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
1208912|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
1208913|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
1208914|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
1208915|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
1208916|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
1208917|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
1209454|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1208919|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
1208920|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
1208921|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
1208922|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
1208923|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
1208924|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
1208925|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
1208926|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
1208927|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
1208928|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
1208929|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
1208930|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
1208931|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
1208932|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
1208933|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
1208934|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
1208935|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
1208936|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
1208937|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
1208938|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
1208939|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
1208940|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
1208941|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
1209455|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1208943|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
1208944|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
1208945|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
1208946|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
1208947|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
1208948|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
1208949|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
1208950|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
1208951|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
1208952|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
1208953|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
1208954|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
1208955|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
1208956|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
1208957|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
1208958|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
1208959|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
1208960|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
1208961|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
1208962|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
1208963|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
1208964|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
1208965|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
1209456|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1208966|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
1208967|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
1208968|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
1208969|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
1208970|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
1208971|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
1208972|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
1208973|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
1208974|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
1208975|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
1208976|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
1208977|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
1208978|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
1208979|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
1208980|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
1208981|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
1208982|NCT00270205|E4|Reported Event|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
1208983|NCT00270205|E3|Reported Event|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
1208984|NCT00270205|E2|Reported Event|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
1208985|NCT00270205|E1|Reported Event|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
1208986|NCT00269919|B1|Baseline|Risperidone Long-acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
1208987|NCT00269919|P1|Participant Flow|Risperidone Long-acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly (into a muscle) depending on Investigator’s discretion every 2 weeks for 2 years.
1208988|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
1208989|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
1208990|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg had been administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
1208991|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
1208992|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
1208993|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
1208994|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
1208995|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
1208996|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
1208997|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
1208998|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
1208999|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
1209000|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
1209093|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
1209001|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
1209002|NCT00269919|E1|Reported Event|Risperidone Long-acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
1209003|NCT00269633|B3|Baseline|Total|Total of all reporting groups
1209004|NCT00269633|B2|Baseline|Blue Light Box|"467 nm~Blue Light Box: 467 nm Blue LED Light"
1209005|NCT00269633|B1|Baseline|Red Light Box|"657 nm~Red Light Box: 657 nm Red LED Light"
1209006|NCT00269633|P2|Participant Flow|Blue Light Box 467 nm|LED Blue Light Box 467 nm
1209007|NCT00269633|P1|Participant Flow|Red Light Box 657 nm|LED Red Light Box 657 nm
1209008|NCT00269633|O2|Outcome|Blue Light Box 467 nm|LED Blue Light Box 467 nm
1209009|NCT00269633|O1|Outcome|Red Light Box 657 nm|LED Red Light Box 657 nm
1209010|NCT00269633|E2|Reported Event|Blue Light Box|"467 nm~Blue Light Box: 467 nm Blue LED Light"
1209011|NCT00269633|E1|Reported Event|Red Light Box|Red Light Box: 657 nm Blue LED Light
1209012|NCT00269477|B5|Baseline|Total|Total of all reporting groups
1209013|NCT00269477|B4|Baseline|Meningococcal Vaccine-naive Group 4|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
1209014|NCT00269477|B3|Baseline|Meningococcal Vaccine-naive Group 3|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination
1209015|NCT00269477|B2|Baseline|Menactra® Vaccine Group 2|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
1209016|NCT00269477|B1|Baseline|Menactra® Vaccine Group 1|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
1209017|NCT00269477|P4|Participant Flow|Meningococcal Vaccine-naive Group 4|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
1209018|NCT00269477|P3|Participant Flow|Meningococcal Vaccine-naive Group 3|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination
1209019|NCT00269477|P2|Participant Flow|Menactra® Vaccine Group 2|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
1209020|NCT00269477|P1|Participant Flow|Menactra® Vaccine Group 1|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
1209021|NCT00269477|O4|Outcome|Meningococcal Vaccine-naive Group 4|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
1209022|NCT00269477|O3|Outcome|Meningococcal Vaccine-naive Group 3|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination
1209279|NCT00267748|O1|Outcome|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
1209023|NCT00269477|O2|Outcome|Menactra® Vaccine Group 2|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
1209024|NCT00269477|O1|Outcome|Menactra® Vaccine Group 1|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
1209025|NCT00269477|O4|Outcome|Meningococcal Vaccine-naive Group 4|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
1209026|NCT00269477|O3|Outcome|Meningococcal Vaccine-naive Group 3|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination
1209027|NCT00269477|O2|Outcome|Menactra® Vaccine Group 2|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
1209028|NCT00269477|O1|Outcome|Menactra® Vaccine Group 1|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
1209479|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209029|NCT00269477|E4|Reported Event|Meningococcal Vaccine-naive Group 4|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
1209030|NCT00269477|E3|Reported Event|Meningococcal Vaccine-naive Group 3|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination
1209031|NCT00269477|E2|Reported Event|Menactra® Vaccine Group 2|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
1209032|NCT00269477|E1|Reported Event|Menactra® Vaccine Group 1|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
1209033|NCT00269152|B3|Baseline|Total|Total of all reporting groups
1209034|NCT00269152|B2|Baseline|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles
1209035|NCT00269152|B1|Baseline|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
1209036|NCT00269152|P2|Participant Flow|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 milligrams per milliliter*minute (mg/ml*min), intravenous (IV), every 21 days x 4 cycles
1209037|NCT00269152|P1|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
1209038|NCT00269152|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles
1209039|NCT00269152|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
1209040|NCT00269152|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles
1209041|NCT00269152|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
1209042|NCT00269152|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles
1209043|NCT00269152|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
1209044|NCT00269152|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles
1209045|NCT00269152|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
1209046|NCT00269152|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles
1209047|NCT00269152|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
1209048|NCT00269152|E2|Reported Event|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles
1209049|NCT00269152|E1|Reported Event|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
1209050|NCT00269113|B3|Baseline|Total|Total of all reporting groups
1209457|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209051|NCT00269113|B2|Baseline|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
1209052|NCT00269113|B1|Baseline|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
1209094|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
1212372|NCT00260429|B2|Baseline|Placebo|
1209053|NCT00269113|P2|Participant Flow|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
1209054|NCT00269113|P1|Participant Flow|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 milligrams per square meter (mg/m^2), intravenously (IV), on Days 1 and 2, chlorambucil 3 times (x) 3 mg/m^2, by mouth (PO), every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a complete remission (CR) or partial remission (PR) following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with interferon (IFN) alpha 3 x 4.5 million international units (IU) per week, subcutaneously (SC), until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
1209055|NCT00269113|O2|Outcome|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
1209056|NCT00269113|O1|Outcome|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
1209057|NCT00269113|O2|Outcome|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
1209058|NCT00269113|O1|Outcome|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
1209084|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
1214046|NCT00252967|O1|Outcome|Placebo|
1209059|NCT00269113|O2|Outcome|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
1209060|NCT00269113|O1|Outcome|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
1209061|NCT00269113|O2|Outcome|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
1209062|NCT00269113|O1|Outcome|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
1209063|NCT00269113|O2|Outcome|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
1209064|NCT00269113|O1|Outcome|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
1209065|NCT00269113|O2|Outcome|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
1209066|NCT00269113|O1|Outcome|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
1209085|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
1209086|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
1209067|NCT00269113|O2|Outcome|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
1209068|NCT00269113|O1|Outcome|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
1209069|NCT00269113|E2|Reported Event|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
1209070|NCT00269113|E1|Reported Event|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
1209071|NCT00268983|B3|Baseline|Total|Total of all reporting groups
1209072|NCT00268983|B2|Baseline|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
1209073|NCT00268983|B1|Baseline|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
1209074|NCT00268983|P2|Participant Flow|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
1209075|NCT00268983|P1|Participant Flow|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
1209076|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
1209077|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
1209078|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
1209079|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
1209080|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
1209081|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
1209082|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
1209083|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
1209087|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
1209458|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209088|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
1209089|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
1209090|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
1209091|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
1209092|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
1209414|NCT00267098|P1|Participant Flow|No Implant Attempt|Subjects who did not undergo an implant attempt of a CRT-P or CRT-D device and were not randomized
1209095|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
1209096|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
1209097|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
1209098|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
1209099|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
1209100|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
1209101|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
1209102|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
1209103|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
1209104|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
1209105|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
1209106|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
1209107|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
1209108|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
1209109|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
1209110|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
1209111|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
1209214|NCT00267969|O1|Outcome|Group 1: Ustekinumab 45 mg Withdrawal Group|Patients received ustekinumab 45 mg at Weeks 0, 4, 16 and 28.
1209280|NCT00267748|O2|Outcome|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
1209112|NCT00268983|E2|Reported Event|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
1209113|NCT00268983|E1|Reported Event|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
1209114|NCT00268905|B4|Baseline|Total|Total of all reporting groups
1209115|NCT00268905|B3|Baseline|Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6|Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
1209116|NCT00268905|B2|Baseline|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6|Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
1209117|NCT00268905|B1|Baseline|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5|Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
1209118|NCT00268905|P3|Participant Flow|Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6|Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
1209119|NCT00268905|P2|Participant Flow|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6|Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
1209120|NCT00268905|P1|Participant Flow|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5|Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
1209121|NCT00268905|O3|Outcome|Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6|Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
1209480|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209122|NCT00268905|O2|Outcome|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6|Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
1209123|NCT00268905|O1|Outcome|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5|Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
1209124|NCT00268905|O3|Outcome|Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6|Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
1209125|NCT00268905|O2|Outcome|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6|Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
1209126|NCT00268905|O1|Outcome|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5|Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
1209127|NCT00268905|O3|Outcome|Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6|Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
1209128|NCT00268905|O2|Outcome|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6|Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
1209129|NCT00268905|O1|Outcome|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5|Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
1209130|NCT00268905|E3|Reported Event|Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6|Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
1209131|NCT00268905|E2|Reported Event|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6|Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
1209132|NCT00268905|E1|Reported Event|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5|Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
1209133|NCT00268892|B4|Baseline|Total|Total of all reporting groups
1209134|NCT00268892|B3|Baseline|Degarelix 240/240@60(1-4-7-10)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
1209135|NCT00268892|B2|Baseline|Degarelix 240/240@60(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
1209136|NCT00268892|B1|Baseline|Degarelix 240/240@40(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
1209137|NCT00268892|P3|Participant Flow|Degarelix 240/240@60(1-4-7-10)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
1209138|NCT00268892|P2|Participant Flow|Degarelix 240/240@60(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
1209139|NCT00268892|P1|Participant Flow|Degarelix 240/240@40(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
1209140|NCT00268892|O3|Outcome|Degarelix 240/240@60(1-4-7-10)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
1209141|NCT00268892|O2|Outcome|Degarelix 240/240@60(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
1209281|NCT00267748|O1|Outcome|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
1209142|NCT00268892|O1|Outcome|Degarelix 240/240@40(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
1209143|NCT00268892|O3|Outcome|Degarelix 240/240@60(1-4-7-10)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
1209144|NCT00268892|O2|Outcome|Degarelix 240/240@60(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
1209145|NCT00268892|O1|Outcome|Degarelix 240/240@40(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
1209146|NCT00268892|E3|Reported Event|Degarelix 240/240@60(1-4-7-10)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
1209415|NCT00267098|O2|Outcome|CRT-D: Right Ventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
1209147|NCT00268892|E2|Reported Event|Degarelix 240/240@60(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
1209148|NCT00268892|E1|Reported Event|Degarelix 240/240@40(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
1209149|NCT00268762|B1|Baseline|Intervention|Argatroban IV bolus 100 mcg/kg bolus, followed by Argatroban IV Infusion 1 mcg/kg/min for 48 hours. Dose adjusted for target PTT of 1.75 times the patient's baseline.
1209150|NCT00268762|P1|Participant Flow|Intervention|Argatroban IV bolus 100 mcg/kg bolus, followed by Argatroban IV Infusion 1 mcg/kg/min for 48 hours. Dose adjusted for target partial thromboplastin time (PTT) of 1.75 times the patient's baseline.
1209151|NCT00268762|O1|Outcome|Intervention|Argatroban IV Infusion 1 mcg/kg/min for 48 hours
1209152|NCT00268762|O1|Outcome|Intervention|Argatroban IV Infusion 1 mcg/kg/min for 48 hours
1209153|NCT00268762|O1|Outcome|Intervention|Argatroban IV Infusion 1 mcg/kg/min for 48 hours
1209154|NCT00268762|E1|Reported Event|Intervention|Argatroban IV bolus 100 mcg/kg bolus, followed by Argatroban IV Infusion 1 mcg/kg/min for 48 hours. Dose adjusted for target PTT of 1.75 times the patient's baseline.
1209155|NCT00268463|B3|Baseline|Total|Total of all reporting groups
1209156|NCT00268463|B2|Baseline|Floxuridine + Oxaliplatin + Capecitabine|Floxuridine + Oxaliplatin + Capecitabine
1209157|NCT00268463|B1|Baseline|Capecitabine + Oxaliplatin|Capecitabine + Oxaliplatin
1209158|NCT00268463|P2|Participant Flow|Arm 2: Floxuridine + Oxaliplatin + Capecitabine|"Oxaliplatin 130 mg/m2 IV over 2 hours on day 22 every 42 days for 4 cycles and then on day 1 every 21 days for 4 cycles~Oral capecitabine 850 mg/m2 twice daily on days 22-35 every 42 days for 4 cycles and then on days 1-14 every 21 days for 4 cycles~Continuous hepatic arterial infusion of floxuridine 0.2 mg/kg on days 1-14 every 42 days for 4 cycles"
1209159|NCT00268463|P1|Participant Flow|Arm 1: Capecitabine + Oxaliplatin|"Oxaliplatin 130 mg/m2 IV over 2 hours on day 1 every 21 days for 8 cycles: Arm 1~Oral capecitabine 850 mg/m2 twice daily on days 1-14 every 21 days for 8 cycles: Arm 1"
1209160|NCT00268463|O2|Outcome|Arm 2: Floxuridine + Oxaliplatin + Capecitabine|"Oxaliplatin 130 mg/m2 IV over 2 hours on day 22 every 42 days for 4 cycles and then on day 1 every 21 days for 4 cycles~Oral capecitabine 850 mg/m2 twice daily on days 22-35 every 42 days for 4 cycles and then on days 1-14 every 21 days for 4 cycles~Continuous hepatic arterial infusion of floxuridine 0.2 mg/kg on days 1-14 every 42 days for 4 cycles"
1209161|NCT00268463|O1|Outcome|Arm 1: Capecitabine + Oxaliplatin|"Oxaliplatin 130 mg/m2 IV over 2 hours on day 1 every 21 days for 8 cycles: Arm 1~Oral capecitabine 850 mg/m2 twice daily on days 1-14 every 21 days for 8 cycles: Arm 1"
1209162|NCT00268463|E2|Reported Event|Floxuridine + Oxaliplatin + Capecitabine|Floxuridine + Oxaliplatin + Capecitabine
1209163|NCT00268463|E1|Reported Event|Capecitabine + Oxaliplatin|Capecitabine + Oxaliplatin
1209164|NCT00268437|B1|Baseline|Pemetrexed/Carboplatin|"Pemetrexed+Carboplatin+Radiation >~> carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment. >~> Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment. >~> conventional surgery >~> neoadjuvant therapy >~> radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field)."
1209165|NCT00268437|P1|Participant Flow|Pemetrexed/Carboplatin|"Pemetrexed+Carboplatin+Radiation carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.~Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.~Radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).~Conventional surgery"
1209166|NCT00268437|O1|Outcome|Pemetrexed/Carboplatin|"Pemetrexed+Carboplatin+Radiation carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.~Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.~Radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).~Conventional surgery"
1209215|NCT00267969|O3|Outcome|Ustekinumab 90 mg|Patients received ustekinumab 90 mg at Week 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 90 mg every 12 week maintenance therapy.
1214047|NCT00252967|O2|Outcome|Atorvastatin|
1209167|NCT00268437|O1|Outcome|Pemetrexed/Carboplatin|"Pemetrexed+Carboplatin+Radiation carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.~Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.~Radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).~conventional surgery"
1209168|NCT00268437|E1|Reported Event|Pemetrexed/Carboplatin|"Pemetrexed+Carboplatin+Radiation carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.~Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.~Radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).~Conventional surgery"
1209169|NCT00268346|B3|Baseline|Total|Total of all reporting groups
1209170|NCT00268346|B2|Baseline|Prior Chemotherapy|Patients may not have received more than one previous systemic treatment regimen. Systemic treatment may have been given as part of definitive (adjuvant, neoadjuvant, concurrent, or sequential) management or for metastatic or recurrent disease. Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
1209171|NCT00268346|B1|Baseline|No Prior Chem Therapy|Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
1209223|NCT00267969|O1|Outcome|Placebo|Patients received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
1209172|NCT00268346|P2|Participant Flow|Prior Chemotherapy|Patients may not have received more than one previous systemic treatment regimen. Systemic treatment may have been given as part of definitive (adjuvant, neoadjuvant, concurrent, or sequential) management or for metastatic or recurrent disease. Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
1209173|NCT00268346|P1|Participant Flow|No Prior Chem Therapy|Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
1209174|NCT00268346|O2|Outcome|Prior Chemotherapy|All patients will receive oral ZD1839 250 mg daily. Pill counts will be conducted at every visit to monitor compliance. Treatment will be continued for a minimum of 8 weeks.
1209175|NCT00268346|O1|Outcome|No Prior Therapy|All patients will receive oral ZD1839 250 mg daily. Pill counts will be conducted at every visit to monitor compliance. Treatment will be continued for a minimum of 8 weeks.
1209176|NCT00268346|E2|Reported Event|Prior Chemotherapy|Patients may not have received more than one previous systemic treatment regimen. Systemic treatment may have been given as part of definitive (adjuvant, neoadjuvant, concurrent, or sequential) management or for metastatic or recurrent disease. Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
1209177|NCT00268346|E1|Reported Event|No Prior Chem Therapy|Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
1209178|NCT00268242|B1|Baseline|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.~Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours~Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
1209179|NCT00268242|P1|Participant Flow|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.~Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours~Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
1209180|NCT00268242|O1|Outcome|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.~Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours~Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
1209181|NCT00268242|O1|Outcome|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.~Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours~Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
1209182|NCT00268242|O1|Outcome|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.~Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours~Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
1209183|NCT00268242|O1|Outcome|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.~Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours~Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
1209184|NCT00268242|O1|Outcome|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.~Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours~Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
1209185|NCT00268242|O1|Outcome|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.~Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours~Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
1209186|NCT00268242|E1|Reported Event|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.~Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours~Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
1209282|NCT00267748|E3|Reported Event|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
1214048|NCT00252967|O1|Outcome|Placebo|
1209187|NCT00268203|B1|Baseline|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
1209221|NCT00267969|O3|Outcome|Ustekinumab 90 mg|Patients received ustekinumab 90 mg at Week 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 90 mg every 12 week maintenance therapy.
1209222|NCT00267969|O2|Outcome|Ustekinumab 45 mg|Patients received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 45 mg every 12 week maintenance therapy.
1209188|NCT00268203|P1|Participant Flow|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
1209189|NCT00268203|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
1209190|NCT00268203|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
1209191|NCT00268203|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
1209192|NCT00268203|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
1209193|NCT00268203|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
1209216|NCT00267969|O2|Outcome|Ustekinumab 45 mg|Patients received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 45 mg every 12 week maintenance therapy.
1209217|NCT00267969|O1|Outcome|Placebo|Patients received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
1214049|NCT00252967|O2|Outcome|Atorvastatin|
1209194|NCT00268203|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
1209195|NCT00268203|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
1209196|NCT00268203|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
1209197|NCT00268203|E1|Reported Event|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
1209198|NCT00267969|B4|Baseline|Total|Total of all reporting groups
1209199|NCT00267969|B3|Baseline|Ustekinumab 90 mg|Patients received ustekinumab 90 mg at Week 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 90 mg every 12 week maintenance therapy.
1209200|NCT00267969|B2|Baseline|Ustekinumab 45 mg|Patients received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 45 mg every 12 week maintenance therapy.
1209201|NCT00267969|B1|Baseline|Placebo|Patients received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
1209202|NCT00267969|P7|Participant Flow|Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) – patients receiving ustekinumab 90 mg at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 16 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 90 q12w.
1209203|NCT00267969|P6|Participant Flow|Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) – patients receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving ustekinumab 45 mg q12wk or q8wk from Week 16 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 45 q12w.
1209204|NCT00267969|P5|Participant Flow|Placebo -> Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 12 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 90 q12w.
1209205|NCT00267969|P4|Participant Flow|Placebo -> Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg every 12 weeks (q12wk) or every 8 weeks (q8wk) from Week 12 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 45 q12w.
1209206|NCT00267969|P3|Participant Flow|Ustekinumab 90 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 90 mg group
1209207|NCT00267969|P2|Participant Flow|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg group
1209208|NCT00267969|P1|Participant Flow|Placebo (CP)|Controlled period (Week 0-12) - Placebo group
1209209|NCT00267969|O6|Outcome|Group 6: Combined Ustekinumab Every 12 Weeks|Groups 2 and 4 (Combined Ustekinumab every 12 weeks)
1209210|NCT00267969|O5|Outcome|Group 5: Withdrawal Combined Group|Groups 1 and 3 (Withdrawal Combined)
1209211|NCT00267969|O4|Outcome|Group 4: Ustekinumab 90 mg Every 12 Weeks|Patients received ustekinumab 90 mg at Weeks 0, 4, 16, 28 and 40.
1209212|NCT00267969|O3|Outcome|Group 3: Ustekinumab 90 mg Withdrawal|Patients received ustekinumab 90 mg at Weeks 0, 4, 16 and 28.
1209213|NCT00267969|O2|Outcome|Group 2: Ustekinumab 45 mg Every 12 Weeks|Patients received ustekinumab 45 mg at Weeks 0, 4, 16, 28 and 40.
1214050|NCT00252967|O1|Outcome|Placebo|
1209218|NCT00267969|O3|Outcome|Ustekinumab 90 mg|Patients received ustekinumab 90 mg at Week 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 90 mg every 12 week maintenance therapy.
1209219|NCT00267969|O2|Outcome|Ustekinumab 45 mg|Patients received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 45 mg every 12 week maintenance therapy.
1209220|NCT00267969|O1|Outcome|Placebo|Patients received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
1209601|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
1209224|NCT00267969|E7|Reported Event|Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) – patients receiving ustekinumab 90 mg at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 16 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 90 q12w.
1209225|NCT00267969|E6|Reported Event|Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) – patients receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving ustekinumab 45 mg q12wk or q8wk from Week 16 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 45 q12w.
1209226|NCT00267969|E5|Reported Event|Placebo -> Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 12 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 90 q12w.
1209227|NCT00267969|E4|Reported Event|Placebo -> Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg every 12 weeks (q12wk) or every 8 weeks (q8wk) from Week 12 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 45 q12w.
1209228|NCT00267969|E3|Reported Event|Ustekinumab 90 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 90 mg group
1209229|NCT00267969|E2|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg group
1209230|NCT00267969|E1|Reported Event|Placebo (CP)|Controlled period (Week 0-12) - Placebo group
1209231|NCT00267956|B3|Baseline|Total|Total of all reporting groups
1209232|NCT00267956|B2|Baseline|Group II: Ustekinumab x 4|Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
1209233|NCT00267956|B1|Baseline|Group I: Placebo|Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
1209234|NCT00267956|P4|Participant Flow|Ustekinumab x 4 (After CP)|After Controlled period (Week 12-36) - receiving ustekinumab at Weeks 0, 1, 2, and 3 -> receiving Placebo at Week 12 and Week 16
1209235|NCT00267956|P3|Participant Flow|Placebo -> Ustekinumab (After CP)|After Controlled period (Week 12-36) - receiving Placebo at Weeks 0, 1, 2, and 3 -> receiving ustekinumab at Week 12 and Week 16
1209236|NCT00267956|P2|Participant Flow|Ustekinumab x 4 (CP)|Controlled period (Week 0-12) - Ustekinumab x 4 Group
1209237|NCT00267956|P1|Participant Flow|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
1209238|NCT00267956|O2|Outcome|Group II: Ustekinumab x 4|Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
1209239|NCT00267956|O1|Outcome|Group I: Placebo|Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
1209240|NCT00267956|O2|Outcome|Group II: Ustekinumab x 4|Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
1209241|NCT00267956|O1|Outcome|Group I: Placebo|Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
1209242|NCT00267956|O2|Outcome|Group II: Ustekinumab x 4|Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
1209243|NCT00267956|O1|Outcome|Group I: Placebo|Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
1214051|NCT00252967|O2|Outcome|Atorvastatin|
1209244|NCT00267956|O2|Outcome|Group II: Ustekinumab x 4|Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
1209245|NCT00267956|O1|Outcome|Group I: Placebo|Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
1209246|NCT00267956|O2|Outcome|Group II: Ustekinumab x 4|Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
1209247|NCT00267956|O1|Outcome|Group I: Placebo|Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
1209331|NCT00267488|O1|Outcome|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
1209477|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209248|NCT00267956|O2|Outcome|Group II: Ustekinumab x 4|Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
1209249|NCT00267956|O1|Outcome|Group I: Placebo|Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
1209250|NCT00267956|E4|Reported Event|Ustekinumab x 4 (After CP)|After Controlled period (Week 12-36) - receiving ustekinumab at Weeks 0, 1, 2, and 3 -> receiving Placebo at Week 12 and Week 16
1209251|NCT00267956|E3|Reported Event|Placebo -> Ustekinumab (After CP)|After Controlled period (Week 12-36) - receiving Placebo at Weeks 0, 1, 2, and 3 -> receiving ustekinumab at Week 12 and Week 16
1209252|NCT00267956|E2|Reported Event|Ustekinumab x 4 (CP)|Controlled period (Week 0-12) - Ustekinumab (CNTO 1275) x 4 Group
1209253|NCT00267956|E1|Reported Event|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
1209254|NCT00267774|B3|Baseline|Total|Total of all reporting groups
1209255|NCT00267774|B2|Baseline|Angio-guided PCI|Angio-guided PCI
1209256|NCT00267774|B1|Baseline|FFR Guided PCI|Fractional flow reserve
1209257|NCT00267774|P2|Participant Flow|Angio-guided PCI|Angio-guided PCI
1209258|NCT00267774|P1|Participant Flow|FFR Guided PCI|Fractional flow reserve
1209259|NCT00267774|O2|Outcome|Angio-guided PCI|Angio-guided PCI
1209260|NCT00267774|O1|Outcome|FFR Guided PCI|Fractional flow reserve
1209261|NCT00267774|E2|Reported Event|Angio-guided PCI|Angio-guided PCI
1209262|NCT00267774|E1|Reported Event|FFR Guided PCI|Fractional flow reserve
1209263|NCT00267748|B4|Baseline|Total|Total of all reporting groups
1209264|NCT00267748|B3|Baseline|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
1209265|NCT00267748|B2|Baseline|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
1209266|NCT00267748|B1|Baseline|Sunitinib 37.5 mg + Interferon Alpha-2b|Sunitinib 37.5 mg or 50 mg self administered orally once daily in the evening for 4 consecutive weeks followed by 2 weeks off (Schedule 4/2) to comprise a complete 6-weeks cycle. Concomitant Interferon (IFN) alpha-2b self-administered at a dose of 3 million units (MU) or 6 MU or 9MU subcutaneously (s.c.) 3 times weekly on non-consecutive days for up to 1 year (9 cycles) of treatment or early withdrawal.
1209267|NCT00267748|P3|Participant Flow|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
1209268|NCT00267748|P2|Participant Flow|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
1209269|NCT00267748|P1|Participant Flow|Sunitinib 37.5 mg + Interferon Alpha-2b|Sunitinib 37.5 mg or 50 mg self administered orally once daily in the evening for 4 consecutive weeks followed by 2 weeks off (Schedule 4/2) to comprise a complete 6-weeks cycle. Concomitant Interferon (IFN) alpha-2b self-administered at a dose of 3 million units (MU) or 6 MU or 9MU subcutaneously (s.c.) 3 times weekly on non-consecutive days for up to 1 year (9 cycles) of treatment or early withdrawal.
1209270|NCT00267748|O2|Outcome|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
1209271|NCT00267748|O1|Outcome|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
1209272|NCT00267748|O2|Outcome|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
1209273|NCT00267748|O1|Outcome|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
1209274|NCT00267748|O2|Outcome|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
1209275|NCT00267748|O1|Outcome|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
1209276|NCT00267748|O2|Outcome|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
1209277|NCT00267748|O1|Outcome|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
1209278|NCT00267748|O2|Outcome|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
1210785|NCT00264004|B2|Baseline|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
1209283|NCT00267748|E2|Reported Event|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
1209284|NCT00267748|E1|Reported Event|Sunitinib 37.5 mg + Interferon Alpha-2b|Sunitinib 37.5 mg or 50 mg self administered orally once daily in the evening for 4 consecutive weeks followed by 2 weeks off (Schedule 4/2) to comprise a complete 6-weeks cycle. Concomitant Interferon (IFN) alpha-2b self-administered at a dose of 3 million units (MU) or 6 MU or 9MU subcutaneously (s.c.) 3 times weekly on non-consecutive days for up to 1 year (9 cycles) of treatment or early withdrawal.
1209285|NCT00267696|B1|Baseline|Gemcitabine/Carboplatin/Bevacizumab|"A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.~Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.~Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administred on day 1 and day 15 of a 28 day cycle~Carboplatin"
1209332|NCT00267488|O1|Outcome|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
1214077|NCT00252720|O2|Outcome|Placebo|Placebo Comparator
1209286|NCT00267696|P1|Participant Flow|Gemcitabine/Carboplatin/Bevacizumab|"A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.~Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.~Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle~Carboplatin"
1209287|NCT00267696|O1|Outcome|Gemcitabine/Carboplatin/Bevacizumab|"A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.~Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.~Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle~Carboplatin"
1209288|NCT00267696|O1|Outcome|Gemcitabine/Carboplatin/Bevacizumab|"A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.~Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.~Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle~Carboplatin"
1209289|NCT00267696|E1|Reported Event|Gemcitabine/Carboplatin/Bevacizumab|"A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.~Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.~Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle~Carboplatin"
1209290|NCT00267670|B3|Baseline|Total|Total of all reporting groups
1209291|NCT00267670|B2|Baseline|Placebo|Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose.
1209292|NCT00267670|B1|Baseline|Pentoxifylline|Patients in this group received pentoxifylline 400mg tid for 1 year.
1209293|NCT00267670|P2|Participant Flow|Placebo|This group was given a capsule identical to pentoxifylline that contained sucrose.
1209294|NCT00267670|P1|Participant Flow|Pentoxifylline|This group was given pentoxifylline 400mg thrice daily (tid) for 1 year
1209295|NCT00267670|O2|Outcome|Placebo|Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose thrice daily for 1 year.
1209296|NCT00267670|O1|Outcome|Pentoxifylline|Patients in this group received pentoxifylline 400mg tid for 1 year.
1209297|NCT00267670|O2|Outcome|Placebo|Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose thrice daily for 1 year.
1209298|NCT00267670|O1|Outcome|Pentoxifylline|Patients in this group received pentoxifylline 400mg tid for 1 year.
1209299|NCT00267670|O2|Outcome|Placebo|Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose.
1209300|NCT00267670|O1|Outcome|Pentoxifylline|Patients in this group received pentoxifylline 400mg tid for 1 year.
1209301|NCT00267670|O2|Outcome|Placebo|Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose.
1209302|NCT00267670|O1|Outcome|Pentoxifylline|Patients in this group received pentoxifylline 400mg tid for 1 year.
1209303|NCT00267670|E2|Reported Event|Placebo|Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose thrice daily for 1 year.
1209304|NCT00267670|E1|Reported Event|Pentoxifylline|Patients in this group received pentoxifylline 400mg tid for 1 year.
1209305|NCT00267644|B3|Baseline|Total|Total of all reporting groups
1209306|NCT00267644|B2|Baseline|Controls|
1209307|NCT00267644|B1|Baseline|Cases|
1209308|NCT00267644|P2|Participant Flow|Controls|Hydrated Pediatric Patients
1209309|NCT00267644|P1|Participant Flow|Cases|Dehydrated Pediatric Patients
1209310|NCT00267644|O2|Outcome|Controls|Hydrated Pediatric Patients
1209311|NCT00267644|O1|Outcome|Cases|Dehydrated Pediatric Patients
1209312|NCT00267644|O2|Outcome|Controls|Pediatric Patients that were hydrated
1209313|NCT00267644|O1|Outcome|Cases|Pediatric Patients who were dehydrated
1209314|NCT00267644|E2|Reported Event|Controls|
1209315|NCT00267644|E1|Reported Event|Cases|
1209316|NCT00267631|B3|Baseline|Total|Total of all reporting groups
1209317|NCT00267631|B2|Baseline|Normal Body Weight|Children with a BMI of 25 to 75%
1209318|NCT00267631|B1|Baseline|At Risk Body Weight|Children with BMI greater adn equal to 85%
1209319|NCT00267631|P2|Participant Flow|NOrmal Body Weight|Children with BMI of 25-75%
1209320|NCT00267631|P1|Participant Flow|At Risk Body Weight|Children with BMI greater and equal to 85%
1209321|NCT00267631|O2|Outcome|Normal Body Weight|Children with BMI of 25-75%
1209322|NCT00267631|O1|Outcome|At Risk Body Weight|Children with BMI greater and equal to 85%
1209323|NCT00267631|E2|Reported Event|Normal Body Weight|Children with a BMI of 25 to 75%
1209324|NCT00267631|E1|Reported Event|At Risk Body Weight|Children with a BMI greater and equal to 85%
1209325|NCT00267488|B1|Baseline|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
1209326|NCT00267488|P1|Participant Flow|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
1214052|NCT00252967|O1|Outcome|Placebo|
1209327|NCT00267488|O1|Outcome|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
1209328|NCT00267488|O1|Outcome|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
1209329|NCT00267488|O1|Outcome|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
1209330|NCT00267488|O1|Outcome|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
1209364|NCT00267202|O3|Outcome|All Patients|
1209478|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209333|NCT00267488|E1|Reported Event|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
1209334|NCT00267293|B4|Baseline|Total|Total of all reporting groups
1209335|NCT00267293|B3|Baseline|Group C: Ibuprofen Then Acetaminophen|Time 0 child is given Ibuprofen (10mg/kg) and at time 3 hours is given (15 mg/kg. Temperature in °C measured hourly for 6 hours.
1209336|NCT00267293|B2|Baseline|Group B: Ibuprofen and Acetaminophen|time 0 child Ibuprofen (10mg/kg) and Acetaminophen (15 mg/kg)given. Temperature in °C measured hourly for 6 hours.
1209337|NCT00267293|B1|Baseline|Group A: Ibuprofen Alone|Time 0 Ibuprofen (10mg/kg)given. Temperature in °C measured hourly for 6 hours.
1209338|NCT00267293|P3|Participant Flow|Group C: Ibuprofen Then Acetaminophen|Time 0 child is given Ibuprofen (10mg/kg) and at time 3 hours is given (15 mg/kg. Temperature in °C measured hourly for 6 hours.
1209339|NCT00267293|P2|Participant Flow|Group B: Ibuprofen and Acetaminophen|time 0 child Ibuprofen (10mg/kg) and Acetaminophen (15 mg/kg)given. Temperature in °C measured hourly for 6 hours.
1209340|NCT00267293|P1|Participant Flow|Group A: Ibuprofen Alone|Time 0 Ibuprofen (10mg/kg)given. Temperature in °C measured hourly for 6 hours.
1209341|NCT00267293|O3|Outcome|Group C: Ibuprofen Then Acetaminophen|Time 0 child is given Ibuprofen (10mg/kg) and at time 3 hours is given (15 mg/kg. Temperature in °C measured hourly for 6 hours.
1209342|NCT00267293|O2|Outcome|Group B: Ibuprofen and Acetaminophen|time 0 child Ibuprofen (10mg/kg) and Acetaminophen (15 mg/kg)given. Temperature in °C measured hourly for 6 hours.
1209343|NCT00267293|O1|Outcome|Group A: Ibuprofen Alone|Time 0 Ibuprofen (10mg/kg)given. Temperature in °C measured hourly for 6 hours.
1209344|NCT00267293|E3|Reported Event|Group C: Ibuprofen Then Acetaminophen|Time 0 child is given Ibuprofen (10mg/kg) and at time 3 hours is given (15 mg/kg. Temperature in °C measured hourly for 6 hours.
1209345|NCT00267293|E2|Reported Event|Group B: Ibuprofen and Acetaminophen|time 0 child Ibuprofen (10mg/kg) and Acetaminophen (15 mg/kg)given. Temperature in °C measured hourly for 6 hours.
1209346|NCT00267293|E1|Reported Event|Group A: Ibuprofen Alone|Time 0 Ibuprofen (10mg/kg)given. Temperature in °C measured hourly for 6 hours.
1209347|NCT00267202|B3|Baseline|Total|Total of all reporting groups
1209348|NCT00267202|B2|Baseline|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
1209349|NCT00267202|B1|Baseline|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
1209350|NCT00267202|P2|Participant Flow|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
1209351|NCT00267202|P1|Participant Flow|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
1209352|NCT00267202|O3|Outcome|All Patients|
1209353|NCT00267202|O2|Outcome|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
1209354|NCT00267202|O1|Outcome|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
1209355|NCT00267202|O3|Outcome|All Patients|
1209356|NCT00267202|O2|Outcome|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
1209357|NCT00267202|O1|Outcome|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
1209358|NCT00267202|O3|Outcome|All Patients|
1209403|NCT00267098|B4|Baseline|CRT-P: Right Ventricular Pacing Arm|Subjects who were implanted with a CRT-P device and randomized to receive right ventricular pacing
1209459|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209359|NCT00267202|O2|Outcome|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
1209360|NCT00267202|O1|Outcome|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
1209361|NCT00267202|O3|Outcome|All Patients|
1209362|NCT00267202|O2|Outcome|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
1209363|NCT00267202|O1|Outcome|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
1209365|NCT00267202|O2|Outcome|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
1209366|NCT00267202|O1|Outcome|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
1209367|NCT00267202|E2|Reported Event|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
1209368|NCT00267202|E1|Reported Event|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
1209369|NCT00267189|B3|Baseline|Total|Total of all reporting groups
1209370|NCT00267189|B2|Baseline|Group 2 (Control)|Standard CNI dose ± mycophenolate acid (MPA)/azathioprine (AZA) ± steroids
1209371|NCT00267189|B1|Baseline|Group 1 (Everolimus)|Reduced or discontinued CNI dose + everolimus (3-12 ng/mL) ± steroids
1209372|NCT00267189|P2|Participant Flow|Group 2 (Control)|Standard CNI dose ± mycophenolate acid (MPA)/azathioprine (AZA) ± steroids
1209373|NCT00267189|P1|Participant Flow|Group 1 (Everolimus)|Reduced or discontinued CNI dose + everolimus (3-12 ng/mL) ± steroids
1209374|NCT00267189|O2|Outcome|Group 2 (Control)|Standard CNI dose ± mycophenolate acid (MPA)/azathioprine (AZA) ± steroids
1209375|NCT00267189|O1|Outcome|Group 1 (Everolimus)|Reduced or discontinued CNI dose + everolimus (3-12 ng/mL) ± steroids
1209376|NCT00267189|O2|Outcome|Group 2 (Control)|Standard CNI dose ± mycophenolate acid (MPA)/azathioprine (AZA) ± steroids
1209377|NCT00267189|O1|Outcome|Group 1 (Everolimus)|Reduced or discontinued CNI dose + everolimus (3-12 ng/mL) ± steroids
1209378|NCT00267189|O2|Outcome|Group 2 (Control)|Standard CNI dose ± mycophenolate acid (MPA)/azathioprine (AZA) ± steroids
1209379|NCT00267189|O1|Outcome|Group 1 (Everolimus)|Reduced or discontinued CNI dose + everolimus (3-12 ng/mL) ± steroids
1209380|NCT00267189|E2|Reported Event|Group 2 (Control)|Standard calcineurin inhibitor dose ± mycophenolate acid/azathioprine ± steroids
1209381|NCT00267189|E1|Reported Event|Group 1 (Everolimus)|Reduced calcineurin inhibitor dose + everolimus (1.5 mg twice daily) ± steroids
1209382|NCT00267150|B1|Baseline|Enteric Coated Mycophenolate-sodium|Enteric coated tablets of mycophenolate-sodium taken orally twice a day for 6-8 weeks.
1209383|NCT00267150|P1|Participant Flow|Enteric Coated Mycophenolate-sodium|Enteric coated tablets of mycophenolate-sodium taken orally twice a day for 6-8 weeks.
1209384|NCT00267150|O1|Outcome|Enteric Coated Mycophenolate-sodium|Enteric coated tablets of mycophenolate-sodium taken orally twice a day for 6-8 weeks.
1209385|NCT00267150|O1|Outcome|Enteric Coated Mycophenolate-sodium|Enteric coated tablets of mycophenolate-sodium taken orally twice a day for 6-8 weeks.
1209386|NCT00267150|E1|Reported Event|All Patients|All patients
1209387|NCT00267111|B3|Baseline|Total|Total of all reporting groups
1209388|NCT00267111|B2|Baseline|Placebo Group|1 g Eucerin plus was used as a placebo.
1209389|NCT00267111|B1|Baseline|Amethocaine Gel 4% Group|1 g of topical amethocaine gel 4%.
1209390|NCT00267111|P2|Participant Flow|Placebo Group|1 g Eucerin plus was used as a placebo.
1209391|NCT00267111|P1|Participant Flow|Amethocaine Gel 4% Group|1 g of topical amethocaine gel 4%.
1209392|NCT00267111|O2|Outcome|Placebo Group|1 g Eucerin plus was used as a placebo
1209393|NCT00267111|O1|Outcome|Amethocaine Gel 4% Group|1 g Amethocaine gel 4% was used as the active drug
1209394|NCT00267111|O2|Outcome|Placebo Group|1 g Eucerin plus was used as a placebo
1209395|NCT00267111|O1|Outcome|1 g Amethocaine Gel 4%|1 g Amethocaine gel 4% was used as the active drug
1209396|NCT00267111|E2|Reported Event|Placebo Group|1 g Eucerin plus was used as a placebo.
1209397|NCT00267111|E1|Reported Event|Amethocaine Gel 4% Group|1 g of topical amethocaine gel 4%.
1209398|NCT00267098|B9|Baseline|Total|Total of all reporting groups
1209399|NCT00267098|B8|Baseline|CRT-D: Not Randomized|Subjects successfully implanted with a CRT-D device who were not randomized
1209400|NCT00267098|B7|Baseline|CRT-D: Right Ventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing.
1209401|NCT00267098|B6|Baseline|CRT-D: Biventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive biventricular pacing
1209402|NCT00267098|B5|Baseline|CRT-P: Not Randomized|Subjects successfully implanted with a CRT-P device who were not randomized
1209460|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209404|NCT00267098|B3|Baseline|CRT-P: Biventricular Pacing Arm|Subjects who were implanted with a CRT-P device and randomized to receive biventricular pacing
1209405|NCT00267098|B2|Baseline|Unsuccessful Implants|Subjects who underwent an implant attempt of a CRT-P or CRT-D device but were not successfully implanted
1209406|NCT00267098|B1|Baseline|No Implant Attempt|Subjects who did not undergo an implant attempt of a CRT-P or CRT-D device and were not randomized
1209407|NCT00267098|P8|Participant Flow|CRT-D: Not Randomized|Subjects successfully implanted with a CRT-D device who were not randomized
1209408|NCT00267098|P7|Participant Flow|CRT-D: Right Ventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing.
1209409|NCT00267098|P6|Participant Flow|CRT-D: Biventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive biventricular pacing
1209410|NCT00267098|P5|Participant Flow|CRT-P: Not Randomized|Subjects successfully implanted with a CRT-P device who were not randomized
1209411|NCT00267098|P4|Participant Flow|CRT-P: Right Ventricular Pacing Arm|Subjects who were implanted with a CRT-P device and randomized to receive right ventricular pacing
1209412|NCT00267098|P3|Participant Flow|CRT-P: Biventricular Pacing Arm|Subjects who were implanted with a CRT-P device and randomized to receive biventricular pacing
1209416|NCT00267098|O1|Outcome|CRT-D: Biventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive biventricular pacing
1209417|NCT00267098|O2|Outcome|Subjects With a CRT-D Implant Attempt|Subjects who underwent an implant attempt for a CRT-D device
1209418|NCT00267098|O1|Outcome|Subjects With a CRT-P Implant Attempt|Subjects who underwent an implant attempt for a CRT-P device
1209419|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing who either worsened prior to the 24 month visit or did not miss their 24 month visit due to study closure
1209420|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing who either worsened prior to the 24 month visit or did not miss their 24 month visit due to study closure
1209421|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing who either worsened prior to the 18 month visit or did not miss their 18 month visit due to study closure
1209422|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing who either worsened prior to the 18 month visit or did not miss their 18 month visit due to study closure
1209423|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing who either worsened prior to the 12 month visit or did not miss their 12 month visit due to study closure
1209424|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing who either worsened prior to the 12 month visit or did not miss their 12 month visit due to study closure
1209425|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209426|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209427|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209428|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209429|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209430|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209431|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209432|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209433|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209434|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209435|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209436|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209437|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209438|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209439|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209440|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209441|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209442|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209443|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209444|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209445|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209446|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209447|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209448|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209449|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209450|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209451|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209452|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209461|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209462|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209463|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209464|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209465|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209466|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209467|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209468|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209469|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209470|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209471|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209472|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209473|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209474|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209475|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209476|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209481|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209482|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209483|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209484|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209485|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209486|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209487|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209488|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209489|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209490|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209491|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209492|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209493|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209494|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209495|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209496|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209497|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209498|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209499|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209500|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209501|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209502|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209503|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209504|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209505|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209506|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209507|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209508|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209509|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209510|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209511|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209512|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209513|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209514|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209515|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209516|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209517|NCT00267098|O4|Outcome|CRT-D: Right Ventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
1210786|NCT00264004|B1|Baseline|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
1209518|NCT00267098|O3|Outcome|CRT-D: Biventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive biventricular pacing
1209519|NCT00267098|O2|Outcome|CRT-P: Right Ventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing.
1209520|NCT00267098|O1|Outcome|CRT-P: Biventricular Pacing Arm|Subjects implanted with a CRT-P device and randomized to receive biventricular pacing
1209521|NCT00267098|O4|Outcome|CRT-D: Right Ventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
1209522|NCT00267098|O3|Outcome|CRT-D: Biventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive biventricular pacing
1209523|NCT00267098|O2|Outcome|CRT-P: Right Ventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing.
1209524|NCT00267098|O1|Outcome|CRT-P: Biventricular Pacing Arm|Subjects implanted with a CRT-P device and randomized to receive biventricular pacing
1209525|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209526|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209527|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209528|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209529|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209530|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209531|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209532|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209533|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209534|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209602|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
1209535|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209536|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209537|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209538|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209539|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
1209540|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
1209541|NCT00267098|E5|Reported Event|No Implant Attempt|Subjects who did not undergo an implant attempt of a CRT-P or CRT-D device and were not randomized
1209542|NCT00267098|E4|Reported Event|Unsuccessful Implants|Subjects who underwent an implant attempt of a CRT-P or CRT-D device but were not successfully implanted
1209543|NCT00267098|E3|Reported Event|CRT: Not Randomized|Subjects successfully implanted with a CRT device who were not randomized
1209544|NCT00267098|E2|Reported Event|Right Ventricular Pacing Arm|Subjects who were implanted with a CRT device and randomized to receive right ventricular pacing
1209545|NCT00267098|E1|Reported Event|Biventricular Pacing Arm|Subjects who were implanted with a CRT device and randomized to receive biventricular pacing
1209546|NCT00267085|B1|Baseline|CML Vaccine|Imatinib mesylate subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, followed by monthly for 10 months
1209547|NCT00267085|P1|Participant Flow|CML Vaccine|Imatinib mesylate subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, followed by monthly for 10 months
1209548|NCT00267085|O1|Outcome|CML Vaccine|Imatinib mesylate subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, followed by monthly for 10 months
1209549|NCT00267085|E1|Reported Event|CML Vaccine|Imatinib mesylate subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, followed by monthly for 10 months
1209550|NCT00267059|B1|Baseline|Lenalidomide|10 mg/day, orally once a day for 28 days
1209551|NCT00267059|P1|Participant Flow|Lenalidomide|10 mg/day, orally once a day for 28 days
1209552|NCT00267059|O1|Outcome|Lenalidomide|10 mg/day, orally once a day for 28 days
1209553|NCT00267059|E1|Reported Event|Lenalidomide|10 mg/day, orally once a day for 28 days
1209554|NCT00267046|B3|Baseline|Total|Total of all reporting groups
1209555|NCT00267046|B2|Baseline|Placebo|"Placebo + Chemotherapy (AI or AP Regimen):~AI = Doxorubicin (Adriamycin) + Ifosfamide:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
1209556|NCT00267046|B1|Baseline|Palifermin|"Palifermin + Chemotherapy (AI or AP Regimen);~AI = Doxorubicin (Adriamycin) + Ifosfamide:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
1209557|NCT00267046|P2|Participant Flow|Placebo|"Placebo + Chemotherapy (AI or AP Regimen):~AI = Doxorubicin (Adriamycin) + Ifosfamide:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
1209628|NCT00266799|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
1209629|NCT00266799|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
1209558|NCT00267046|P1|Participant Flow|Palifermin|"Palifermin + Chemotherapy (AI or AP Regimen);~AI = Doxorubicin (Adriamycin) + Ifosfamide:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
1209559|NCT00267046|O2|Outcome|Placebo|"Placebo + Chemotherapy (AI or AP Regimen):~AI = Doxorubicin (Adriamycin) + Ifosfamide:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
1209560|NCT00267046|O1|Outcome|Palifermin|"Palifermin + Chemotherapy (AI or AP Regimen);~AI = Doxorubicin (Adriamycin) + Ifosfamide:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
1209561|NCT00267046|O2|Outcome|Placebo|"Placebo + Chemotherapy (AI or AP Regimen):~AI = Doxorubicin (Adriamycin) + Ifosfamide:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
1209603|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
1209604|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
1209562|NCT00267046|O1|Outcome|Palifermin|"Palifermin + Chemotherapy (AI or AP Regimen);~AI = Doxorubicin (Adriamycin) + Ifosfamide:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
1209563|NCT00267046|E2|Reported Event|Placebo|"Placebo + Chemotherapy (AI or AP Regimen):~AI = Doxorubicin (Adriamycin) + Ifosfamide:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
1209564|NCT00267046|E1|Reported Event|Palifermin|"Palifermin + Chemotherapy (AI or AP Regimen);~AI = Doxorubicin (Adriamycin) + Ifosfamide:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
1209565|NCT00267007|B3|Baseline|Total|Total of all reporting groups
1209566|NCT00267007|B2|Baseline|Placebo|Equivalent volume to PROCRIT (1 mL) administered every week (QW) for 18 weeks (intravenous or subcutaneous)
1209567|NCT00267007|B1|Baseline|PROCRIT 40,000 IU QW|Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (intravenous or subcutaneous)
1209568|NCT00267007|P2|Participant Flow|Placebo|Equivalent volume to PROCRIT (1 mL) administered every week (QW) for 18 weeks (intravenous or subcutaneous)
1209569|NCT00267007|P1|Participant Flow|PROCRIT 40,000 IU QW|Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (intravenous or subcutaneous)
1209570|NCT00267007|O2|Outcome|Placebo|Equivalent volume to PROCRIT (1 mL) administered every week (QW) for 18 weeks (intravenous or subcutaneous)
1209571|NCT00267007|O1|Outcome|PROCRIT 40,000 IU QW|Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (intravenous or subcutaneous)
1209572|NCT00267007|O2|Outcome|Placebo|Equivalent volume to PROCRIT (1 mL) administered every week (QW) for 18 weeks (intravenous or subcutaneous)
1209573|NCT00267007|O1|Outcome|PROCRIT 40,000 IU QW|Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (intravenous or subcutaneous)
1209574|NCT00267007|E2|Reported Event|Placebo|Equivalent volume to PROCRIT (1 mL) administered every week (QW) for 18 weeks (intravenous or subcutaneous)
1209575|NCT00267007|E1|Reported Event|PROCRIT 40,000 IU QW|Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (intravenous or subcutaneous)
1209576|NCT00266864|B3|Baseline|Total|Total of all reporting groups
1209577|NCT00266864|B2|Baseline|No Intervention|Subjects with normal testosterone levels (eugonadal) participated in identical outcome measurements at parallel time points.
1209578|NCT00266864|B1|Baseline|Testosterone Replacement Therapy|Subjects with Low Testosterone (Hypogonadal) Receive Testosterone Transdermal System (Androderm 5 mg patch)
1209579|NCT00266864|P2|Participant Flow|No Intervention|Control group: subjects in this group will receive no intervention, but will have the same outcome measures as arm 1 completed at the baseline, 12, and 24 month time points.
1209580|NCT00266864|P1|Participant Flow|Testosterone Replacement Therapy|Treatment group: Testosterone Replacement Therapy Patch 5 or 10mg daily (Androderm, Watson Pharma Inc.) for 12 months, with the dose adjusted to raise the serum testosterone concentration to within the normal range.
1209581|NCT00266864|O2|Outcome|No Intervention|Control group: subjects in this group will receive no intervention, but will have the same outcome measures as arm 1 completed at the baseline, 12, and 24 month time points.
1209582|NCT00266864|O1|Outcome|Testosterone Replacement Therapy|Testosterone Replacement Therapy Patch 5 or 10 mg daily
1209583|NCT00266864|O2|Outcome|No Intervention|Control group: subjects in this group will receive no intervention, but will have the same outcome measures as arm 1 completed at the baseline, 12, and 24 month time points.
1209584|NCT00266864|O1|Outcome|Testosterone Replacement Therapy|Treatment group: Testosterone Replacement Therapy Patch 5 or 10mg daily (Androderm, Watson Pharma Inc.) for 12 months, with the dose adjusted to raise the serum testosterone concentration to within the normal range.
1209585|NCT00266864|E1|Reported Event|Testosterone Replacement Therapy|A prospective, open-label, controlled drug intervention trial was performed in healthy hypogonadal and eugonadal outpatient men with chronic spinal cord injury (Treatment: serum testosterone concentration <4.0 mg/dL and Control: serum testosterone concentration ≥4.0 mg/dL). Treatment subjects received a transdermal testosterone patch (5 or 10 mg; Androderm, Watson Pharma Inc.) daily for 12 months, with the dose adjusted to raise the serum testosterone concentration to within the normal range. Only outcome measures were assessed for the no intervention arm; no adverse events were collected.
1209586|NCT00266825|B3|Baseline|Total|Total of all reporting groups
1209587|NCT00266825|B2|Baseline|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
1209588|NCT00266825|B1|Baseline|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
1209589|NCT00266825|P2|Participant Flow|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
1209590|NCT00266825|P1|Participant Flow|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
1209591|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
1209592|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
1209593|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
1209594|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
1209595|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
1209596|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
1209597|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
1209598|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
1209599|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
1209600|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
1209606|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
1209607|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
1209608|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
1209609|NCT00266825|E4|Reported Event|DHA Capsule - Infant|Infants born from Mothers in the DHA capsule group
1209610|NCT00266825|E3|Reported Event|DHA Capsule - Mother|"DHA capsule~DHA: 600 mg DHA"
1209611|NCT00266825|E2|Reported Event|Placebo Capsule - Infant|Infants born from Mothers in the Placebo capsule group
1209612|NCT00266825|E1|Reported Event|Placebo Capsule - Mother|"Placebo capsule~Placebo capsule: Placebo capsule"
1209613|NCT00266812|B3|Baseline|Total|Total of all reporting groups
1209614|NCT00266812|B2|Baseline|Radiotherapy Alone|2 regimens are allowed: a) 20 fractions of 2 Gray each, on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26; b) 10 fractions of 3 Gray each, administered on days 1 to 5 and 8 to 12.
1209615|NCT00266812|B1|Baseline|Chemotherapy With Temozolomide and Radiotherapy|Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2).
1209616|NCT00266812|P2|Participant Flow|Radiotherapy Alone|2 regimens are allowed: a) 20 fractions of 2 Gray each, on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26; b) 10 fractions of 3 Gray each, administered on days 1 to 5 and 8 to 12.
1209617|NCT00266812|P1|Participant Flow|Chemotherapy With Temozolomide and Radiotherapy|Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2).
1209618|NCT00266812|O2|Outcome|Radiotherapy Alone|2 regimens are allowed: a) 20 fractions of 2 Gray each, on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26; b) 10 fractions of 3 Gray each, administered on days 1 to 5 and 8 to 12.
1209619|NCT00266812|O1|Outcome|Chemotherapy With Temozolomide and Radiotherapy|Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2).
1209620|NCT00266812|E2|Reported Event|Radiotherapy Alone|2 regimens are allowed: a) 20 fractions of 2 Gray each, on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26; b) 10 fractions of 3 Gray each, administered on days 1 to 5 and 8 to 12.
1209621|NCT00266812|E1|Reported Event|Chemotherapy With Temozolomide and Radiotherapy|Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2).
1209622|NCT00266799|B3|Baseline|Total|Total of all reporting groups
1209623|NCT00266799|B2|Baseline|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
1209624|NCT00266799|B1|Baseline|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
1209625|NCT00266799|P2|Participant Flow|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
1209626|NCT00266799|P1|Participant Flow|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
1209627|NCT00266799|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
1214053|NCT00252967|O2|Outcome|Atorvastatin|
1209630|NCT00266799|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
1209631|NCT00266799|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
1209632|NCT00266799|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
1209633|NCT00266799|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
1209634|NCT00266799|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
1209635|NCT00266799|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
1209636|NCT00266799|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
1209637|NCT00266799|E2|Reported Event|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
1209638|NCT00266799|E1|Reported Event|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
1209639|NCT00266695|B1|Baseline|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
1209640|NCT00266695|P1|Participant Flow|Ruboxistaurin|32 milligrams (mg) given once daily as an oral tablet for 2 years.
1209641|NCT00266695|O1|Outcome|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
1209642|NCT00266695|O1|Outcome|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
1209643|NCT00266695|O1|Outcome|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
1209644|NCT00266695|O1|Outcome|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
1209645|NCT00266695|O1|Outcome|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
1209646|NCT00266695|O1|Outcome|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
1209647|NCT00266695|O1|Outcome|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
1209648|NCT00266695|E1|Reported Event|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
1209649|NCT00266656|B3|Baseline|Total|Total of all reporting groups
1209650|NCT00266656|B2|Baseline|Early Untreated|Early untreated n=33
1209651|NCT00266656|B1|Baseline|Early Treated|Early treated n=36
1209652|NCT00266656|P2|Participant Flow|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
1209653|NCT00266656|P1|Participant Flow|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
1209654|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
1209655|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
1209656|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
1209657|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
1209658|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
1209659|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
1209660|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
1209661|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
1209662|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
1209663|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
1209664|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
1209665|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
1209666|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
1209667|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
1209902|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209668|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
1209669|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
1209670|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
1209671|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
1209672|NCT00266656|E2|Reported Event|Early Untreated|"Humatrope administered according to investigator's clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
1209673|NCT00266656|E1|Reported Event|Early Treated|"Humatrope administered according to investigator's clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
1209674|NCT00266630|B3|Baseline|Total|Total of all reporting groups
1209675|NCT00266630|B2|Baseline|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
1209676|NCT00266630|B1|Baseline|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
1209677|NCT00266630|P2|Participant Flow|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
1209678|NCT00266630|P1|Participant Flow|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
1209754|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209679|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
1209680|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
1209681|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
1209682|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
1209683|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
1209684|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
1209685|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
1209686|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
1209687|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
1209688|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
1209689|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
1209690|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
1209691|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
1209692|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
1209693|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
1209694|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
1209695|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
1209696|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
1214054|NCT00252967|O1|Outcome|Placebo|
1209697|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
1209698|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
1209699|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
1209700|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
1209701|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
1209702|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
1209703|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
1209704|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
1209705|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
1209755|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1214609|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
1209706|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
1209707|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
1209708|NCT00266630|O1|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
1209709|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
1209710|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
1209711|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
1209712|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
1209713|NCT00266630|E2|Reported Event|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
1209714|NCT00266630|E1|Reported Event|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
1209715|NCT00266409|B5|Baseline|Total|Total of all reporting groups
1209716|NCT00266409|B4|Baseline|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209717|NCT00266409|B3|Baseline|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209718|NCT00266409|B2|Baseline|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209719|NCT00266409|B1|Baseline|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209720|NCT00266409|P4|Participant Flow|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209721|NCT00266409|P3|Participant Flow|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209722|NCT00266409|P2|Participant Flow|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209723|NCT00266409|P1|Participant Flow|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209724|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209725|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209726|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209727|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209728|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209729|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209730|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209731|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209732|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209733|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209734|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209735|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209736|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209737|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209738|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209739|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209740|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209741|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209742|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209743|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209744|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209745|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209746|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209747|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209748|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209749|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209750|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209751|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209752|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209753|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209756|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209757|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209758|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209759|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209760|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209761|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209762|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209763|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209764|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209765|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209766|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209767|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209768|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209769|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209770|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209771|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209772|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209773|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209774|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209775|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209776|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209777|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209778|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209779|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209780|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209781|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209782|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209783|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209784|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209785|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209786|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209787|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209788|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209789|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209790|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209791|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209958|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209792|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209793|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209794|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209795|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209796|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209797|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209798|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209799|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209800|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209801|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209802|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209803|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209804|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209805|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209806|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209807|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209808|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209809|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209810|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209811|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209812|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209813|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209814|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209815|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209816|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209817|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209818|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209819|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209820|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209821|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209822|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209823|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209824|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209825|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209826|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209827|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209828|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209829|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209830|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209831|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209832|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209833|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209834|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209835|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209836|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209837|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209838|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209839|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209840|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209841|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209842|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209843|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209844|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209845|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209846|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1210787|NCT00264004|P4|Participant Flow|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
1209847|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209848|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209849|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209850|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209851|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209852|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209853|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209854|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209855|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209856|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209857|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209858|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209859|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209860|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209861|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209862|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209863|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209864|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1210805|NCT00264004|O2|Outcome|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
1209865|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209866|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209867|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209868|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209869|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209870|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209871|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209872|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209873|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209874|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209875|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209876|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209877|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209878|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209879|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209880|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209881|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209882|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209883|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209884|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209885|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209886|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209887|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209888|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209889|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209890|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209891|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209892|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209893|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209894|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209895|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209896|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209897|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209898|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209899|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209900|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209901|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1214055|NCT00252967|O2|Outcome|Atorvastatin|
1209903|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209904|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209905|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209906|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209907|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209908|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209909|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209910|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209911|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209912|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209913|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209914|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209915|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209916|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209917|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209918|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209919|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209920|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209921|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209922|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209923|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209924|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209925|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209926|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209927|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209928|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209929|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209930|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209931|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209932|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209933|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209934|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209935|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209936|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209937|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209938|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209939|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209940|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209941|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209942|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209943|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209944|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209945|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209946|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209947|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209948|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209949|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209950|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209951|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209952|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209953|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209954|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209955|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209956|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209957|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1214056|NCT00252967|O1|Outcome|Placebo|
1209959|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209960|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209961|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209962|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209963|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209964|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209965|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209966|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209967|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209968|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209969|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209970|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209971|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209972|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209973|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209974|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209975|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209976|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209977|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209978|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209979|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209980|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209981|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209982|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209983|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209984|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209985|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209986|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209987|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209988|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209989|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209990|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209991|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209992|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209993|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209994|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209995|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1209996|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1209997|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1209998|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1209999|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1210000|NCT00266409|E4|Reported Event|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
1210001|NCT00266409|E3|Reported Event|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
1210002|NCT00266409|E2|Reported Event|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
1210003|NCT00266409|E1|Reported Event|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
1210004|NCT00265395|B3|Baseline|Total|Total of all reporting groups
1210005|NCT00265395|B2|Baseline|Extended Therapy (72-week Treatment)|Slow responders (defined as being PCR positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to continue treatment to Week 72.
1210006|NCT00265395|B1|Baseline|Standard Therapy (48-week Treatment)|Slow responders (defined as being polymerase chain reaction [PCR] positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to stop treatment at Week 48.
1210007|NCT00265395|P2|Participant Flow|Extended Therapy (72-week Treatment)|Slow responders (defined as being PCR positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to continue treatment to Week 72.
1210008|NCT00265395|P1|Participant Flow|Standard Therapy (48-week Treatment)|Slow responders (defined as being polymerase chain reaction [PCR] positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to stop treatment at Week 48.
1210395|NCT00265239|E1|Reported Event|Edaravone Group|"Edaravone Group~edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy"
1210009|NCT00265395|O2|Outcome|Extended Therapy (72-week Treatment)|Slow responders (defined as being PCR positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to continue treatment to Week 72.
1210010|NCT00265395|O1|Outcome|Standard Therapy (48-week Treatment)|Slow responders (defined as being polymerase chain reaction [PCR] positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to stop treatment at Week 48.
1210011|NCT00265395|E1|Reported Event|Standard Therapy (48-week Treatment)|
1210012|NCT00265382|B1|Baseline|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
1210013|NCT00265382|P1|Participant Flow|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 milligrams (mg)/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kilograms (kg). For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg twice a day [BID]). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
1210014|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
1210015|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
1214610|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
1210016|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
1210017|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
1210018|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
1210019|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
1210020|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
1210021|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
1210022|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
1210023|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
1210024|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
1210025|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
1210026|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
1210027|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
1210077|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210028|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
1210029|NCT00265382|E1|Reported Event|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 milligrams (mg)/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kilograms (kg). For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg twice a day [BID]). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
1210030|NCT00265343|B3|Baseline|Total|Total of all reporting groups
1210031|NCT00265343|B2|Baseline|Olanzapine|5-20 mg daily (QD) orally (PO)
1210032|NCT00265343|B1|Baseline|Asenapine|5-10 mg twice daily (bid) sublingual (SL)
1210033|NCT00265343|P2|Participant Flow|Olanzapine|5-20 mg daily (QD) orally (PO)
1210034|NCT00265343|P1|Participant Flow|Asenapine|5-10 mg twice daily (bid) sublingual (SL)
1210035|NCT00265343|O2|Outcome|Olanzapine|5-20 mg daily (QD) orally (PO)
1210036|NCT00265343|O1|Outcome|Asenapine|5-10 mg twice daily (bid) sublingual (SL)
1210037|NCT00265343|O2|Outcome|Olanzapine|5-20 mg daily (QD) orally (PO)
1210038|NCT00265343|O1|Outcome|Asenapine|5-10 mg twice daily (bid) sublingual (SL)
1210039|NCT00265343|E2|Reported Event|Olanzapine|
1210040|NCT00265343|E1|Reported Event|Asenapine|
1210041|NCT00265330|B1|Baseline|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
1210042|NCT00265330|P1|Participant Flow|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
1210043|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
1210044|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
1210045|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
1210046|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
1210047|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
1210048|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
1210049|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
1210050|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
1210051|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
1210052|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
1210053|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
1210054|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
1210055|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
1210056|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
1210057|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
1210058|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
1210346|NCT00265616|B2|Baseline|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
1210059|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
1210060|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
1210061|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
1210062|NCT00265330|E1|Reported Event|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
1210063|NCT00265317|B5|Baseline|Total|Total of all reporting groups
1210064|NCT00265317|B4|Baseline|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210065|NCT00265317|B3|Baseline|Sunitinib + Erlotinib|Sunitinib oral capsules, 37.5 mg QD in a continuous regimen, expressed in 4-week cycles and Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles.
1210066|NCT00265317|B2|Baseline|Sunitinib + Erlotinib (Amended Lead-in)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1, Arm A or 13 days in Cycle 1, Arm B) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1, Arm A or 26 days in Cycle 1, Arm B)
1210067|NCT00265317|B1|Baseline|Sunitinib + Erlotinib (Original Lead-In)|Sunitinib 37.5 mg oral capsules once daily (QD) for 28 days each cycle with exception of Cycle 2 (27 days) and Erlotinib 150 mg oral tablets QD for 28 days each cycle with exception of Cycle 1 (35 days).
1210068|NCT00265317|P4|Participant Flow|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210069|NCT00265317|P3|Participant Flow|Sunitinib + Erlotinib|Sunitinib oral capsules, 37.5 mg QD in a continuous regimen, expressed in 4-week cycles and Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles.
1210070|NCT00265317|P2|Participant Flow|Sunitinib + Erlotinib (Amended Lead-in)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1, Arm A or 13 days in Cycle 1, Arm B) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1, Arm A or 26 days in Cycle 1, Arm B)
1210071|NCT00265317|P1|Participant Flow|Sunitinib + Erlotinib (Original Lead-In)|Sunitinib 37.5 mg oral capsules once daily (QD) for 28 days each cycle with exception of Cycle 2 (27 days) and Erlotinib 150 mg oral tablets QD for 28 days each cycle with exception of Cycle 1 (35 days).
1210072|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210073|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210074|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210075|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210076|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210142|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (All Combined)|Combined Data from all participants in the Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), and Randomized Cohort
1210078|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210079|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210080|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210081|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210082|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210083|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210084|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210085|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210086|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210087|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210088|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210089|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210090|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210091|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210092|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210093|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210094|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210095|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210096|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210097|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210098|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210099|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210100|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210101|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210102|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210103|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210104|NCT00265317|O1|Outcome|All Participants|All participants in all phases.
1210105|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210106|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210107|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210108|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210109|NCT00265317|O1|Outcome|All Participants|All participants in all phases
1210396|NCT00265200|B1|Baseline|Zoledronic Acid|3.0-4.0 mg by IV (in the vein), once a month for 6 months
1210110|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210111|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210112|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210113|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210114|NCT00265317|O1|Outcome|All Participants|All participants in all phases.
1210115|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210116|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210117|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210118|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210806|NCT00264004|O1|Outcome|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
1210119|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210120|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210121|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210122|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210123|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210124|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210125|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210126|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210127|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210128|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210129|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210130|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210131|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210132|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210133|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210134|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210135|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210136|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210137|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210138|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210139|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (All Combined)|Combined Data from all participants in the Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), and Randomized Cohort
1210140|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (All Combined)|Combined Data from all participants in the Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), and Randomized Cohort
1210141|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (All Combined)|Combined Data from all participants in the Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), and Randomized Cohort
1214057|NCT00252967|O2|Outcome|Atorvastatin|
1210143|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (All Combined)|Combined Data from all participants in the Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), and Randomized Cohort
1210144|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (All Combined)|Combined Data from all participants in the Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), and Randomized Cohort
1210145|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
1210146|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
1210147|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
1210148|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm A)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1).
1210149|NCT00265317|O2|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
1210150|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Original Lead-In)|Sunitinib 37.5 mg oral capsules once daily (QD) for 28 days each cycle with exception of Cycle 2 (27 days)and Erlotinib 150 mg oral tablets QD for 28 days each cycle with exception of Cycle 1 (35 days).
1214611|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
1210151|NCT00265317|O2|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm A)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1).
1210152|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Original Lead-In)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1).
1210153|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
1210154|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm A)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1).
1210155|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
1210156|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
1210157|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
1210158|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm A)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1).
1210159|NCT00265317|O1|Outcome|Sunitinib+Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
1210160|NCT00265317|O1|Outcome|Sunitinib+Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
1210161|NCT00265317|O1|Outcome|Sunitinib+Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
1210162|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm A)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1).
1210163|NCT00265317|O1|Outcome|Sunitinib+Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
1210164|NCT00265317|O1|Outcome|Sunitinib+Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
1210165|NCT00265317|O1|Outcome|Sunitinib+Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
1210166|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm A)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1).
1210167|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210168|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210169|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210170|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210171|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210172|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210378|NCT00265473|O1|Outcome|Experimental|Islet infusion with MGA031 induction and sirolimus and tacrolimus maintenance immunosuppression.
1210173|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210174|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210175|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210176|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210177|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210178|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210179|NCT00265317|E4|Reported Event|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
1210180|NCT00265317|E3|Reported Event|Sunitinib + Erlotinib|Sunitinib oral capsules, 37.5 mg QD in a continuous regimen, expressed in 4-week cycles and Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles.
1210181|NCT00265317|E2|Reported Event|Sunitinib + Erlotinib (Amended Lead-in)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1, Arm A or 13 days in Cycle 1, Arm B) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1, Arm A or 26 days in Cycle 1, Arm B)
1210182|NCT00265317|E1|Reported Event|Sunitinib + Erlotinib (Original Lead-In)|Sunitinib 37.5 mg oral capsules once daily (QD) for 28 days each cycle with exception of Cycle 2 (27 days) and Erlotinib 150 mg oral tablets QD for 28 days each cycle with exception of Cycle 1 (35 days).
1210183|NCT00266279|B1|Baseline|Treatment With Study Drugs|"Treatment with combination of oxaliplatin and capecitabine using study dose and schedule.~Oxaliplatin, Capecitabine : Agent, DOSE AND SCHEDULE (28-days cycle):~Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21"
1210184|NCT00266279|P1|Participant Flow|Treatment With Study Drugs|"Treatment with combination of oxaliplatin and capecitabine using study dose and schedule.~Oxaliplatin, Capecitabine : Agent, DOSE AND SCHEDULE (28-days cycle):~Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21"
1210185|NCT00266279|O1|Outcome|Treatment With Study Drugs|"Treatment with combination of oxaliplatin and capecitabine using study dose and schedule.~Oxaliplatin, Capecitabine : Agent, DOSE AND SCHEDULE (28-days cycle):~Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21"
1210186|NCT00266279|E1|Reported Event|Treatment With Study Drugs|"Treatment with combination of oxaliplatin and capecitabine using study dose and schedule.~Oxaliplatin, Capecitabine : Agent, DOSE AND SCHEDULE (28-days cycle):~Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21"
1210187|NCT00266227|B3|Baseline|Total|Total of all reporting groups
1210188|NCT00266227|B2|Baseline|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
1210189|NCT00266227|B1|Baseline|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
1210190|NCT00266227|P3|Participant Flow|Rituximab-Not Randomized to Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate. Participants were not randomized to Retreatment.
1210191|NCT00266227|P2|Participant Flow|Arm B: Placebo Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by retreatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/week methotrexate.
1210192|NCT00266227|P1|Participant Flow|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
1210193|NCT00266227|O2|Outcome|Arm B: Placebo Re-treatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
1210194|NCT00266227|O1|Outcome|Arm A: Rituximab Re-treatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
1210195|NCT00266227|O2|Outcome|Arm B: Placebo Re-treatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
1210196|NCT00266227|O1|Outcome|Arm A: Rituximab Re-treatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
1210197|NCT00266227|O2|Outcome|Arm B: Placebo Re-treatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
1210198|NCT00266227|O1|Outcome|Arm A: Rituximab Re-treatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
1210199|NCT00266227|O2|Outcome|Arm B: Placebo Re-treatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
1210379|NCT00265473|O1|Outcome|Experimental|Islet infusion
1214058|NCT00252967|O1|Outcome|Placebo|
1210200|NCT00266227|O1|Outcome|Arm A: Rituximab Re-treatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
1210201|NCT00266227|O2|Outcome|Arm B: Placebo Re-treatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
1210202|NCT00266227|O1|Outcome|Arm A: Rituximab Re-treatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
1210203|NCT00266227|O2|Outcome|Arm B: Placebo Re-treatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
1210204|NCT00266227|O1|Outcome|Arm A: Rituximab Re-treatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
1210205|NCT00266227|O2|Outcome|Arm B: Placebo Re-treatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
1210807|NCT00264004|O4|Outcome|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
1210206|NCT00266227|O1|Outcome|Arm A: Rituximab Re-treatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
1210207|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
1210208|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
1210209|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
1210210|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
1210211|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
1210212|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
1210213|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
1210214|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
1210215|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
1210216|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
1210217|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
1210218|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
1210219|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
1210220|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
1210221|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
1210222|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
1210223|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
1210224|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
1210788|NCT00264004|P3|Participant Flow|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
1210225|NCT00266227|O2|Outcome|Arm B: Placebo Re-treatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
1210226|NCT00266227|O1|Outcome|Arm A: Rituximab Re-treatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
1210227|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
1210228|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
1210229|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
1210230|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
1210231|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
1210232|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
1210233|NCT00266227|E3|Reported Event|Rituximab-Not Randomized to Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate. Participants were not randomized to Retreatment.
1210234|NCT00266227|E2|Reported Event|Arm B: Placebo Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by retreatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/week methotrexate.
1210235|NCT00266227|E1|Reported Event|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
1210236|NCT00266110|B1|Baseline|Dendritic Cell Vaccine|"Therapeutic autologous dendritic cells (Dendritic Cell Vaccine) i.d. injection, 20 x 106 DCs given per treatment Trastuzumab infusion Vinorelbine ditartrate infusion~sargramostim: All patients will receive Leukine (GM-CSF) at 250 mcg/m2 starting one day after the administration of chemotherapy x 7 days. Patients with neutrophil counts below 1,000/mm3 on day 8 will continue GM-CSF therapy until the neutrophil count is greater than 1,000/mm3.~therapeutic autologous dendritic cells: patients will receive (10 x 106) peptide-pulsed DCs given by i.d injection into either axilla or the inguinal region with each peptide given into a separate site. The total dose will be 20 x 106 DCs given per treatment.~trastuzumab: Trastuzumab will be infused in the side-port of a freely flowing IV over 90 minutes and at 6mg/kg if the subject has not previously received Trastuzumab, or if it has been more than 30 days since any prior trastuzumab administration."
1210237|NCT00266110|P1|Participant Flow|Dendritic Cell Vaccine|"Therapeutic autologous dendritic cells (Dendritic Cell Vaccine) i.d. injection, 20 x 106 DCs given per treatment Trastuzumab infusion Vinorelbine ditartrate infusion~Sargramostim: All patients will receive Leukine (GM-CSF) at 250 mcg/m2 starting one day after the administration of chemotherapy x 7 days. Patients with neutrophil counts below 1,000/mm3 on day 8 will continue GM-CSF therapy until the neutrophil count is greater than 1,000/mm3.~Therapeutic autologous dendritic cells: patients will receive (10 x 106) peptide-pulsed dendritic cells (DCs) given by i.d injection into either axilla or the inguinal region with each peptide given into a separate site. The total dose will be 20 x 106 DCs given per treatment.~Trastuzumab: Trastuzumab will be infused in the side-port of a freely flowing IV over 90 minutes and at 6mg/kg if the subject has not previously received Trastuzumab, or if it has been more than 30 days since any prior trastuzumab administration."
1210238|NCT00266110|O1|Outcome|Dendritic Cell Vaccine|"Therapeutic autologous dendritic cells (Dendritic Cell Vaccine) i.d. injection, 20 x 106 DCs given per treatment Trastuzumab infusion Vinorelbine ditartrate infusion~sargramostim: All patients will receive Leukine (GM-CSF) at 250 mcg/m2 starting one day after the administration of chemotherapy x 7 days. Patients with neutrophil counts below 1,000/mm3 on day 8 will continue GM-CSF therapy until the neutrophil count is greater than 1,000/mm3.~therapeutic autologous dendritic cells: patients will receive (10 x 106) peptide-pulsed DCs given by i.d injection into either axilla or the inguinal region with each peptide given into a separate site. The total dose will be 20 x 106 DCs given per treatment.~trastuzumab: Trastuzumab will be infused in the side-port of a freely flowing IV over 90 minutes and at 6mg/kg if the subject has not previously received Trastuzumab, or if it has been more than 30 days since any prior trastuzumab administration."
1210239|NCT00266110|E1|Reported Event|Dendritic Cell Vaccine|"Therapeutic autologous dendritic cells (Dendritic Cell Vaccine) i.d. injection, 20 x 106 DCs given per treatment Trastuzumab infusion Vinorelbine ditartrate infusion~sargramostim: All patients will receive Leukine (GM-CSF) at 250 mcg/m2 starting one day after the administration of chemotherapy x 7 days. Patients with neutrophil counts below 1,000/mm3 on day 8 will continue GM-CSF therapy until the neutrophil count is greater than 1,000/mm3.~therapeutic autologous dendritic cells: patients will receive (10 x 106) peptide-pulsed DCs given by i.d injection into either axilla or the inguinal region with each peptide given into a separate site. The total dose will be 20 x 106 DCs given per treatment.~trastuzumab: Trastuzumab will be infused in the side-port of a freely flowing IV over 90 minutes and at 6mg/kg if the subject has not previously received Trastuzumab, or if it has been more than 30 days since any prior trastuzumab administration."
1210240|NCT00266032|B4|Baseline|Total|Total of all reporting groups
1210380|NCT00265473|E1|Reported Event|Experimental|Islet infusion with MGA031 induction and sirolimus and tacrolimus maintenance immunosuppression.
1210381|NCT00265239|B3|Baseline|Total|Total of all reporting groups
1210382|NCT00265239|B2|Baseline|Placebo Group|Placebo Group
1210241|NCT00266032|B3|Baseline|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
1210242|NCT00266032|B2|Baseline|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
1210243|NCT00266032|B1|Baseline|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1210294|NCT00265798|B1|Baseline|Sorafenib|Patients receive oral Sorafenib 400mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1210808|NCT00264004|O3|Outcome|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
1210244|NCT00266032|P3|Participant Flow|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
1210245|NCT00266032|P2|Participant Flow|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
1210246|NCT00266032|P1|Participant Flow|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1210247|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1210248|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1210249|NCT00266032|O2|Outcome|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
1210250|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1210251|NCT00266032|O3|Outcome|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
1210252|NCT00266032|O2|Outcome|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
1210253|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1210254|NCT00266032|O3|Outcome|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
1210383|NCT00265239|B1|Baseline|Edaravone Group|"Edaravone Group~edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy"
1210384|NCT00265239|P2|Participant Flow|Placebo Group|Placebo Group
1214059|NCT00252967|E2|Reported Event|Atorvastatin|
1210255|NCT00266032|O2|Outcome|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
1210256|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1210257|NCT00266032|O3|Outcome|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
1210258|NCT00266032|O2|Outcome|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
1210259|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1210260|NCT00266032|O3|Outcome|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
1210261|NCT00266032|O2|Outcome|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
1210262|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1210263|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1210264|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1210265|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1210266|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1210267|NCT00266032|O3|Outcome|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
1210268|NCT00266032|O2|Outcome|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
1210269|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1210270|NCT00266032|E3|Reported Event|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
1210271|NCT00266032|E2|Reported Event|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
1210272|NCT00266032|E1|Reported Event|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
1210273|NCT00265889|B1|Baseline|Poor Risk Patients|Poor Risk (primary progressive, recurrent, or resistant relapse)
1210274|NCT00265889|P1|Participant Flow|Poor Risk Patients|Poor Risk (primary progressive, recurrent, or resistant relapse)
1210275|NCT00265889|O1|Outcome|Poor Risk Patients|Poor Risk (primary progressive, recurrent, or resistant relapse)
1210276|NCT00265889|O1|Outcome|Poor Risk Patients|Poor Risk (primary progressive, recurrent, or resistant relapse)
1210277|NCT00265889|O1|Outcome|Poor Risk Patients|Poor Risk (primary progressive, recurrent, or resistant relapse)
1210278|NCT00265889|E1|Reported Event|Poor Risk Patients|Poor Risk (primary progressive, recurrent, or resistant relapse)
1210279|NCT00265850|B4|Baseline|Total|Total of all reporting groups
1210280|NCT00265850|B3|Baseline|Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
1210281|NCT00265850|B2|Baseline|Arm B: FOLFOX or FOLFIRI + Cetuximab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
1210282|NCT00265850|B1|Baseline|Arm A: FOLFOX or FOLFIRI + Bevacizumab|"Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
1210283|NCT00265850|P3|Participant Flow|Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
1210284|NCT00265850|P2|Participant Flow|Arm B: FOLFOX or FOLFIRI + Cetuximab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
1210285|NCT00265850|P1|Participant Flow|Arm A: FOLFOX or FOLFIRI + Bevacizumab|"Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
1210295|NCT00265798|P1|Participant Flow|Sorafenib|Patients receive oral Sorafenib 400mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1210296|NCT00265798|O1|Outcome|Sorafenib|Patients receive oral Sorafenib 400mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1210297|NCT00265798|O1|Outcome|Sorafenib|Patients receive oral Sorafenib 400mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1210286|NCT00265850|O3|Outcome|Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
1210287|NCT00265850|O2|Outcome|Arm B: FOLFOX or FOLFIRI + Cetuximab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
1210288|NCT00265850|O1|Outcome|Arm A: FOLFOX or FOLFIRI + Bevacizumab|"Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
1210289|NCT00265850|O3|Outcome|Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
1210290|NCT00265850|O2|Outcome|Arm B: FOLFOX or FOLFIRI + Cetuximab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
1210291|NCT00265850|O1|Outcome|Arm A: FOLFOX or FOLFIRI + Bevacizumab|"Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
1210292|NCT00265850|E2|Reported Event|Arm B: FOLFOX or FOLFIRI + Cetuximab|"Patients receive cetuximab 400mg/m^2 IV over 2 hours on the first day of treatment, then 250 mg/m^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
1210385|NCT00265239|P1|Participant Flow|Edaravone Group|"Edaravone Group~edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy"
1210386|NCT00265239|O2|Outcome|Placebo Group|Placebo Group
1210387|NCT00265239|O1|Outcome|Edaravone Group|"Edaravone Group~edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy"
1210388|NCT00265239|O2|Outcome|Placebo Group|Placebo Group
1210293|NCT00265850|E1|Reported Event|Arm A: FOLFOX or FOLFIRI + Bevacizumab|"Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned.~FOLFOX or: Patients receive oxaliplatin 85 mg/m^2 IV infused over two hours followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus, then 2400 mg/m^2 continuous IV infusion over 46-48 hours~FOLFIRI: Patients receive irinotecan 180 mg/m^2 IV infused over 90 minutes followed by leucovorin 400 mg/m^2 IV over 2 hours followed by 5-FU 400 mg/m^2 IV bolus following leucovorin then 2400 mg/m^2 continuous IV infusion over 46-48 hours."
1210298|NCT00265798|O1|Outcome|Sorafenib|Patients receive oral Sorafenib 400mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1210299|NCT00265798|E1|Reported Event|Sorafenib|Patients receive oral Sorafenib 400mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1210300|NCT00265785|B1|Baseline|Pemetrexed|Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
1210301|NCT00265785|P1|Participant Flow|Pemetrexed|Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
1210302|NCT00265785|O1|Outcome|Premetrexed|Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
1210303|NCT00265785|O1|Outcome|Premetrexed|Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
1210304|NCT00265785|O1|Outcome|Premetrexed|Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
1210305|NCT00265785|O1|Outcome|Premetrexed|Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
1210306|NCT00265785|E1|Reported Event|Pemetrexed|Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
1210307|NCT00265759|B7|Baseline|Total|Total of all reporting groups
1210308|NCT00265759|B6|Baseline|Cohort B Arm III: Week 2 Ki67 No Invasive Disease Present|Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the biopsy core contained insufficient tumor to perform the Ki67 assay patients could elect to be re-biopsied at 4 weeks or continue on AI therapy. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
1210309|NCT00265759|B5|Baseline|Cohort B Arm II: Week 2 Ki67 >10%|Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. Women whose two-week Ki67 level was > 10% were offered either a NCCN approved neoadjuvant chemotherapy regimen or surgery at the discretion of providers/patients. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
1210310|NCT00265759|B4|Baseline|Cohort B Arm I: Week 2 Ki67 <=10%|Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the Ki67 was ≤10% the patient continued AI therapy for another 12-14 weeks and then proceeded to surgery. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
1210311|NCT00265759|B3|Baseline|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
1210312|NCT00265759|B2|Baseline|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
1210313|NCT00265759|B1|Baseline|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
1210389|NCT00265239|O1|Outcome|Edaravone Group|"Edaravone Group~edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy"
1210390|NCT00265239|O2|Outcome|Placebo Group|Placebo Group
1210391|NCT00265239|O1|Outcome|Edaravone Group|"Edaravone Group~edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy"
1210392|NCT00265239|O2|Outcome|Placebo Group|Placebo Group
1210314|NCT00265759|P4|Participant Flow|Cohort B|Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the Ki67 was ≤10% the patient continued AI therapy for another 12-14 weeks and then proceeded to surgery. Women whose two-week Ki67 level was > 10% were offered either a NCCN approved neoadjuvant chemotherapy regimen or surgery at the discretion of providers/patients. If the biopsy core contained insufficient tumor to perform the Ki67 assay patients could elect to be re-biopsied at 4 weeks or continue on AI therapy. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
1210315|NCT00265759|P3|Participant Flow|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection.
1210316|NCT00265759|P2|Participant Flow|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection.
1210317|NCT00265759|P1|Participant Flow|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection.
1210318|NCT00265759|O3|Outcome|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
1210319|NCT00265759|O2|Outcome|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
1210320|NCT00265759|O1|Outcome|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
1210321|NCT00265759|O1|Outcome|Cohort B|Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the Ki67 was ≤10% the patient continued AI therapy for another 12-14 weeks and then proceeded to surgery. Women whose two-week Ki67 level was > 10% were offered either a NCCN approved neoadjuvant chemotherapy regimen or surgery at the discretion of providers/patients. If the biopsy core contained insufficient tumor to perform the Ki67 assay patients could elect to be re-biopsied at 4 weeks or continue on AI therapy. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
1210322|NCT00265759|O3|Outcome|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
1210323|NCT00265759|O2|Outcome|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
1210324|NCT00265759|O1|Outcome|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
1210325|NCT00265759|O3|Outcome|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
1210326|NCT00265759|O2|Outcome|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
1210327|NCT00265759|O1|Outcome|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
1210328|NCT00265759|O3|Outcome|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
1210329|NCT00265759|O2|Outcome|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
1210330|NCT00265759|O1|Outcome|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
1210331|NCT00265759|O3|Outcome|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
1210332|NCT00265759|O2|Outcome|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
1210333|NCT00265759|O1|Outcome|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
1210334|NCT00265759|O3|Outcome|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
1210335|NCT00265759|O2|Outcome|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
1210336|NCT00265759|O1|Outcome|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
1210337|NCT00265759|O1|Outcome|Cohort B Arm II: Week 2 Ki67 > 10%|Patients who after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy had a tumor Ki67 level of greater than 10% and switched to neoadjuvant chemotherapy.
1210338|NCT00265759|O3|Outcome|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
1210339|NCT00265759|O2|Outcome|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
1210340|NCT00265759|O1|Outcome|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
1210393|NCT00265239|O1|Outcome|Edaravone Group|"Edaravone Group~edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy"
1210394|NCT00265239|E2|Reported Event|Placebo Group|Placebo Group
1210341|NCT00265759|E4|Reported Event|Cohort B|Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the Ki67 was ≤10% the patient continued AI therapy for another 12-14 weeks and then proceeded to surgery. Women whose two-week Ki67 level was > 10% were offered either a NCCN approved neoadjuvant chemotherapy regimen or surgery at the discretion of providers/patients. If the biopsy core contained insufficient tumor to perform the Ki67 assay patients could elect to be re-biopsied at 4 weeks or continue on AI therapy. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
1210342|NCT00265759|E3|Reported Event|Cohort A Arm III: Anastrozole|Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
1210343|NCT00265759|E2|Reported Event|Cohort A Arm II: Letrozole|Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
1210344|NCT00265759|E1|Reported Event|Cohort A Arm I: Exemestane|Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
1210345|NCT00265616|B3|Baseline|Total|Total of all reporting groups
1210809|NCT00264004|O2|Outcome|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
1210347|NCT00265616|B1|Baseline|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
1210348|NCT00265616|P2|Participant Flow|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG); no maximum doses defined.
1210349|NCT00265616|P1|Participant Flow|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG);no maximum doses defined.
1210350|NCT00265616|O2|Outcome|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
1210351|NCT00265616|O1|Outcome|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
1210352|NCT00265616|O2|Outcome|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
1210353|NCT00265616|O1|Outcome|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
1210354|NCT00265616|O2|Outcome|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
1210355|NCT00265616|O1|Outcome|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
1210356|NCT00265616|O2|Outcome|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
1210357|NCT00265616|O1|Outcome|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
1210358|NCT00265616|O2|Outcome|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
1210359|NCT00265616|O1|Outcome|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
1210360|NCT00265616|O2|Outcome|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
1210361|NCT00265616|O1|Outcome|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
1210362|NCT00265616|E2|Reported Event|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
1210363|NCT00265616|E1|Reported Event|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
1210364|NCT00265512|B3|Baseline|Total|Total of all reporting groups
1210365|NCT00265512|B2|Baseline|Arm 2|"Continuing Care as Usual~Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment."
1210366|NCT00265512|B1|Baseline|Arm 1|"Telephone Case Monitoring Aftercare~Telephone Case Monitoring: Telephone Case Monitoring involves telephone delivery of continuing care treatment post intensive outpatient SUD treatment. It includes brief weekly phone calls with a counselor for up to 6 months."
1210367|NCT00265512|P2|Participant Flow|Arm 2|"Continuing Care as Usual~Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment."
1210368|NCT00265512|P1|Participant Flow|Arm 1|"Telephone Case Monitoring Aftercare~Telephone Case Monitoring: Telephone Case Monitoring involves telephone delivery of continuing care treatment post intensive outpatient SUD treatment. It includes brief weekly phone calls with a counselor for up to 6 months."
1210369|NCT00265512|O2|Outcome|Arm 2|"Continuing Care as Usual~Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment."
1210370|NCT00265512|O1|Outcome|Arm 1|"Telephone Case Monitoring Aftercare~Telephone Case Monitoring: Telephone Case Monitoring involves telephone delivery of continuing care treatment post intensive outpatient SUD treatment. It includes brief weekly phone calls with a counselor for up to 6 months."
1210371|NCT00265512|E2|Reported Event|Arm 2|"Continuing Care as Usual~Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment.~SAEs were tracked, but AEs were not tracked."
1210372|NCT00265512|E1|Reported Event|Arm 1|"Telephone Case Monitoring Aftercare~Telephone Case Monitoring: Telephone Case Monitoring involves telephone delivery of continuing care treatment post intensive outpatient SUD treatment. It includes brief weekly phone calls with a counselor for up to 6 months.~SAEs were tracked, but AEs were not tracked."
1210373|NCT00265473|B1|Baseline|Experimental|Islet infusion with MGA031 induction and sirolimus and tacrolimus maintenance immunosuppression.
1210374|NCT00265473|P1|Participant Flow|Experimental|Islet infusion with MGA031 induction and sirolimus and tacrolimus maintenance immunosuppression.
1210375|NCT00265473|O1|Outcome|Experimental|Islet infusion
1210376|NCT00265473|O1|Outcome|Experimental|Islet infusion
1210377|NCT00265473|O1|Outcome|Experimental|Islet infusion
1214060|NCT00252967|E1|Reported Event|Placebo|
1210397|NCT00265200|P1|Participant Flow|Zoledronic Acid|3.0-4.0 mg by IV (in the vein), once a month for 6 months
1210398|NCT00265200|O1|Outcome|Zoledronic Acid|3.0-4.0 mg by IV (in the vein), once a month for 6 months
1210399|NCT00265200|E1|Reported Event|Zoledronic Acid|3.0-4.0 mg by IV (in the vein), once a month for 6 months
1210400|NCT00265122|B7|Baseline|Total|Total of all reporting groups
1210401|NCT00265122|B6|Baseline|Population 2: Ustekinumab 4.5 mg/kg IV|Ustekinumab 4.5 mg given as one intravenous (IV) infusion at Week 0 during Intervention Period 1. No intervention given during Intervention Period 2.
1210402|NCT00265122|B5|Baseline|Population 2: Ustekinumab 90 mg SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week at Weeks 0-3 during Intervention Period 1. No intervention given during Intervention Period 2.
1210403|NCT00265122|B4|Baseline|Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV|Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2.
1210404|NCT00265122|B3|Baseline|Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV|Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2.
1210810|NCT00264004|O1|Outcome|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
1210811|NCT00264004|E4|Reported Event|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
1210405|NCT00265122|B2|Baseline|Population 1: Ustekinumab 90 mg SC Followed by Placebo SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
1210406|NCT00265122|B1|Baseline|Population 1: Placebo SC Followed by Ustekinumab SC|Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
1210407|NCT00265122|P6|Participant Flow|Population 2: Ustekinumab 4.5 mg/kg IV|Ustekinumab 4.5 mg given as one intravenous (IV) infusion at Week 0 during Intervention Period 1. No intervention given during Intervention Period 2.
1210408|NCT00265122|P5|Participant Flow|Population 2: Ustekinumab 90 mg SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week at Weeks 0-3 during Intervention Period 1. No intervention given during Intervention Period 2.
1210409|NCT00265122|P4|Participant Flow|Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV|Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2.
1210410|NCT00265122|P3|Participant Flow|Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV|Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2.
1210411|NCT00265122|P2|Participant Flow|Population 1: Ustekinumab 90 mg SC Followed by Placebo SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
1210412|NCT00265122|P1|Participant Flow|Population 1: Placebo SC Followed by Ustekinumab SC|Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
1210413|NCT00265122|O6|Outcome|Population 1: Ustekinumab SC and IV Combined|All participants who received Ustekinumab SC and Ustekinumab IV
1210414|NCT00265122|O5|Outcome|Population 1: Placebo SC and IV Combined|All participants who received Placebo SC and Placebo IV
1210415|NCT00265122|O4|Outcome|Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV|Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2.
1210416|NCT00265122|O3|Outcome|Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV|Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2.
1210417|NCT00265122|O2|Outcome|Population 1: Ustekinumab 90 mg SC Followed by Placebo SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
1210418|NCT00265122|O1|Outcome|Population 1:Placebo SC Followed by Ustekinumab 90 mg SC|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 1, 2, 3 (Intervention Period 1: Weeks 0-8), and 90 mg ustekinumab SC at Weeks 8, 9, 10 and 11 (Intervention Period 2: Weeks 8-28)
1210419|NCT00265122|O2|Outcome|Population 2: Ustekinumab 4.5 mg/kg IV|Ustekinumab 4.5 mg given as one intravenous (IV) infusion at Week 0 during Intervention Period 1. No intervention given during Intervention Period 2.
1210420|NCT00265122|O1|Outcome|Population 2: Ustekinumab 90 SC|Paticipants received ustekinumab 90 mg subcutaneously (SC) at Weeks 0, 1, 2, and 3 (Intervention Period 1: Weeks 0-8), and did not receive any study agent from Week 8 onward (Intervention Period 2: Weeks 8-28)
1210421|NCT00265122|O6|Outcome|Population 1: Ustekinumab SC and IV Combined|All participants who received Ustekinumab 90 mg SC and Ustekinumab 4.5 mg/kg IV
1210422|NCT00265122|O5|Outcome|Population 1: Placebo SC and IV Combined|All particpants who received Placebo SC and Placebo IV
1210423|NCT00265122|O4|Outcome|Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV|Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2.
1210424|NCT00265122|O3|Outcome|Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV|Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2.
1210425|NCT00265122|O2|Outcome|Population 1: Ustekinumab 90 mg SC Followed by Placebo SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
1210426|NCT00265122|O1|Outcome|Population 1: Placebo SC Followed by Ustekinumab SC|Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
1210427|NCT00265122|E6|Reported Event|Population 2: Ustekinumab 4.5 mg/kg IV|Ustekinumab 4.5 mg given as one intravenous (IV) infusion at Week 0 during Intervention Period 1. No intervention given during Intervention Period 2.
1210789|NCT00264004|P2|Participant Flow|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
1210428|NCT00265122|E5|Reported Event|Population 2: Ustekinumab 90 mg SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week at Weeks 0-3 during Intervention Period 1. No intervention given during Intervention Period 2.
1210429|NCT00265122|E4|Reported Event|Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV|"Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2. NOTE: 26 participants randomized to this treatment group + 1 participant randomized to treatment with Placebo IV followed by Ustekinumab 4.5 mg/kg IV who received ustekinumab IV at Week 0 was included in the Total # at Risk by any Serious Adverse Event and Total # at Risk by any Other Adverse Event listed below."
1210451|NCT00265096|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
1210452|NCT00265096|O4|Outcome|Combined: Group II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
1210430|NCT00265122|E3|Reported Event|Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV|"Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2. NOTE: 8 of 27 participants randomized to this treatment group were excluded from the Total # at Risk by any Serious Adverse Event and Total # at Risk by any Other Adverse Event listed below for the following reasons: 7 participants received placebo only were excluded from the analysis of adverse events and 1 participant received ustekinumab IV at Week 0 and was included in the analysis of adverse events in the treatment group labelled Ustekinumab 4.5 mg/kg IV followed by Placebo IV."
1210431|NCT00265122|E2|Reported Event|Population 1: Ustekinumab 90 mg SC Followed by Placebo SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
1210432|NCT00265122|E1|Reported Event|Population 1: Placebo SC Followed by Ustekinumab SC|"Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2. NOTE: 4 of 26 participants randomized to this treatment group received placebo only and were excluded from the Total # at Risk by any Serious Adverse Event and Total # at Risk by any Other Adverse Event listed below."
1210433|NCT00265109|B1|Baseline|Open-Label Levetiracetam|All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.
1210434|NCT00265109|P1|Participant Flow|Open-Label Levetiracetam|All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.
1210435|NCT00265109|O1|Outcome|Open-Label Levetiracetam|All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.
1210436|NCT00265109|E1|Reported Event|Open-Label Levetiracetam|All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.
1210437|NCT00265096|B4|Baseline|Total|Total of all reporting groups
1210438|NCT00265096|B3|Baseline|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 weeks from Wk 0 up to 5 yrs.
1210439|NCT00265096|B2|Baseline|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
1210440|NCT00265096|B1|Baseline|Group 1: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
1210441|NCT00265096|P3|Participant Flow|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 weeks from Wk 0 up to 5 yrs.
1210442|NCT00265096|P2|Participant Flow|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
1210443|NCT00265096|P1|Participant Flow|Group 1: Placebo|Group 1: Placebo Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
1210444|NCT00265096|O4|Outcome|Combined: Group II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
1210445|NCT00265096|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 weeks from Wk 0 up to 5 yrs.
1210446|NCT00265096|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
1210447|NCT00265096|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
1214061|NCT00252733|B3|Baseline|Total|Total of all reporting groups
1210448|NCT00265096|O4|Outcome|Combined: Group II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
1210449|NCT00265096|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 weeks from Wk 0 up to 5 yrs.
1210450|NCT00265096|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
1210453|NCT00265096|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
1210454|NCT00265096|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
1210455|NCT00265096|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
1210456|NCT00265096|O4|Outcome|Combined: Group II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
1210457|NCT00265096|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
1210458|NCT00265096|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
1210459|NCT00265096|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
1210460|NCT00265096|O4|Outcome|Combined: Group II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
1210461|NCT00265096|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
1210462|NCT00265096|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
1210463|NCT00265096|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
1210464|NCT00265096|O4|Outcome|Combined: Group II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
1210465|NCT00265096|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 weeks from Wk 0 up to 5 yrs.
1210466|NCT00265096|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
1210467|NCT00265096|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
1210468|NCT00265096|E3|Reported Event|Group 3: Golimumab 50 and 100 mg|Subjects who were treated with Golimumab and received at least one injection of both Golimumab 50 mg and Golimumab 100 mg.
1210469|NCT00265096|E2|Reported Event|Group 2: Golimumab 100 mg|Subjects who were treated with Golimumab and received Golimumab 100 mg injections only.
1210470|NCT00265096|E1|Reported Event|Group 1: Golimumab 50 mg|Subjects who were treated with Golimumab and received Golimumab 50 mg injections only.
1210471|NCT00265083|B4|Baseline|Total|Total of all reporting groups
1210472|NCT00265083|B3|Baseline|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
1210473|NCT00265083|B2|Baseline|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
1210474|NCT00265083|B1|Baseline|Group I: Placebo|Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
1210475|NCT00265083|P3|Participant Flow|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
1210584|NCT00264576|O1|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell- culture-derived trivalent influenza vaccine (cTIV).
1210476|NCT00265083|P2|Participant Flow|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
1210477|NCT00265083|P1|Participant Flow|Group 1: Placebo|Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
1210478|NCT00265083|O4|Outcome|Combined: Groups II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
1210479|NCT00265083|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
1210480|NCT00265083|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
1210593|NCT00264576|E2|Reported Event|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
1210481|NCT00265083|O1|Outcome|Group I: Placebo|Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
1210482|NCT00265083|O4|Outcome|Combined: Groups II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
1210483|NCT00265083|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
1210484|NCT00265083|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
1210485|NCT00265083|O1|Outcome|Group I: Placebo|Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
1210486|NCT00265083|O4|Outcome|Combined: Groups II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
1210487|NCT00265083|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
1210488|NCT00265083|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
1210489|NCT00265083|O1|Outcome|Group I: Placebo|Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
1210490|NCT00265083|O4|Outcome|Combined: Groups II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
1210491|NCT00265083|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
1210492|NCT00265083|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
1210493|NCT00265083|O1|Outcome|Group I: Placebo|Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
1210494|NCT00265083|E3|Reported Event|Group 3: Golimumab 50 and 100 mg|Subjects who were treated with Golimumab and received at least one injection of both Golimumab 50 mg and Golimumab 100 mg.
1210495|NCT00265083|E2|Reported Event|Group 2: Golimumab 100 mg|Subjects who were treated with Golimumab and received Golimumab 100 mg injections only.
1210496|NCT00265083|E1|Reported Event|Group 1: Golimumab 50 mg|Subjects who were treated with Golimumab and received Golimumab 50 mg injections only.
1210497|NCT00264875|B1|Baseline|Pregabalin|Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs).
1210498|NCT00264875|P1|Participant Flow|Pregabalin|Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs).
1210499|NCT00264875|O1|Outcome|Pregabalin|Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs).
1210500|NCT00264875|E1|Reported Event|Pregabalin|Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs).
1210501|NCT00264849|B3|Baseline|Total|Total of all reporting groups
1210502|NCT00264849|B2|Baseline|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
1210503|NCT00264849|B1|Baseline|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
1210585|NCT00264576|O2|Outcome|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
1210504|NCT00264849|P2|Participant Flow|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
1210505|NCT00264849|P1|Participant Flow|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
1210506|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
1214612|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
1210507|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
1210508|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
1210509|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
1210510|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
1210511|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
1210512|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
1210513|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
1210514|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
1210515|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
1210516|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
1210517|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
1210518|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
1210519|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
1210520|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
1210521|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
1210790|NCT00264004|P1|Participant Flow|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
1210522|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
1210523|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
1210524|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
1210525|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
1210526|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
1210527|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
1210528|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
1210529|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
1210530|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
1210531|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
1210532|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
1210533|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
1210534|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
1210535|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
1210536|NCT00264849|E2|Reported Event|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
1210537|NCT00264849|E1|Reported Event|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
1210538|NCT00264810|B3|Baseline|Total|Total of all reporting groups
1210539|NCT00264810|B2|Baseline|Sham Group (Stimulation OFF)|Group of subjects that have undergone RNS® System implantation that are randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the Blinded Evaluation Period. Stimulation is enabled after transition into the Open Label Period (sixth month post-implant) and may continue for the remainder of the subject's participation in the study.
1210540|NCT00264810|B1|Baseline|Treatment Group (Stimulation ON)|Group of subjects that have undergone RNS® System implantation that are randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the Blinded Evaluation Period. Stimulation is enabled during the Stimulation Optimization Period (second month post-implant) and may continue throughout the subject's participation in the study.
1210541|NCT00264810|P2|Participant Flow|Sham Group (Stimulation OFF)|Group of subjects that have undergone RNS® System implantation that are randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the Blinded Evaluation Period. Stimulation is enabled after transition into the Open Label Period (sixth month post-implant) and may continue for the remainder of the subject's participation in the study.
1210542|NCT00264810|P1|Participant Flow|Treatment Group (Stimulation ON)|Group of subjects that have undergone RNS® System implantation that are randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the Blinded Evaluation Period. Stimulation is enabled during the Stimulation Optimization Period (second month post-implant) and may continue throughout the subject's participation in the study.
1210594|NCT00264576|E1|Reported Event|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
1210595|NCT00264550|B5|Baseline|Total|Total of all reporting groups
1210543|NCT00264810|O2|Outcome|Sham Group (Stimulation OFF)|Group of subjects that have undergone RNS® System implantation that are randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the Blinded Evaluation Period. Stimulation is enabled after transition into the Open Label Period (sixth month post-implant) and may continue for the remainder of the subject's participation in the study.
1210544|NCT00264810|O1|Outcome|Treatment Group (Stimulation ON)|Group of subjects that have undergone RNS® System implantation that are randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the Blinded Evaluation Period. Stimulation is enabled during the Stimulation Optimization Period (second month post-implant) and may continue throughout the subject's participation in the study.
1210545|NCT00264810|O1|Outcome|Implanted Subjects|Subjects implanted with the RNS® System.
1210546|NCT00264810|O1|Outcome|Implanted Subjects|Subjects implanted with the RNS® System
1210547|NCT00264810|E2|Reported Event|Sham Group (Stimulation OFF)|Group of subjects that have undergone RNS® System implantation that are randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the Blinded Evaluation Period. Stimulation is enabled after transition into the Open Label Period (sixth month post-implant) and may continue for the remainder of the subject's participation in the study.
1210548|NCT00264810|E1|Reported Event|Treatment Group (Stimulation ON)|Group of subjects that have undergone RNS® System implantation that are randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the Blinded Evaluation Period. Stimulation is enabled during the Stimulation Optimization Period (second month post-implant) and may continue throughout the subject's participation in the study.
1210549|NCT00264797|B3|Baseline|Total|Total of all reporting groups
1210550|NCT00264797|B2|Baseline|Methylphenidate (Placebo)|Methylphenidate (OROS-MPH) - Placebo : Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
1210551|NCT00264797|B1|Baseline|Methylphenidate|Methylphenidate (OROS-MPH) : Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
1210552|NCT00264797|P2|Participant Flow|Methylphenidate (Placebo)|Methylphenidate (OROS-MPH) - Placebo : Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
1210553|NCT00264797|P1|Participant Flow|Methylphenidate|Methylphenidate (OROS-MPH) : Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
1210554|NCT00264797|O2|Outcome|Methylphenidate (Placebo)|Methylphenidate (OROS-MPH) - Placebo : Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
1210555|NCT00264797|O1|Outcome|Methylphenidate|Methylphenidate (OROS-MPH) : Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
1210556|NCT00264797|O2|Outcome|Methylphenidate (Placebo)|Methylphenidate (OROS-MPH) - Placebo : Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
1210586|NCT00264576|O1|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
1210587|NCT00264576|O2|Outcome|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
1210588|NCT00264576|O1|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
1210557|NCT00264797|O1|Outcome|Methylphenidate|Methylphenidate (OROS-MPH) : Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
1210684|NCT00264381|B2|Baseline|Dalteparin 200 U/kg Then 10,000 U Daily|"Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days~+ additional 7 days of same therapy based on results of ultrasound at day 7"
1210558|NCT00264797|O2|Outcome|Methylphenidate (Placebo)|Methylphenidate (OROS-MPH) - Placebo : Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
1210559|NCT00264797|O1|Outcome|Methylphenidate|Methylphenidate (OROS-MPH) : Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
1210560|NCT00264797|O2|Outcome|Methylphenidate (Placebo)|Methylphenidate (OROS-MPH) - Placebo : Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
1210561|NCT00264797|O1|Outcome|Methylphenidate|Methylphenidate (OROS-MPH) : Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
1210562|NCT00264797|E2|Reported Event|Methylphenidate (Placebo)|Methylphenidate (OROS-MPH) - Placebo : Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
1210563|NCT00264797|E1|Reported Event|Methylphenidate|Methylphenidate (OROS-MPH) : Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
1210564|NCT00264641|B3|Baseline|Total|Total of all reporting groups
1210565|NCT00264641|B2|Baseline|Low RAS Activity|Low RAS activity is defined in the protocol
1210566|NCT00264641|B1|Baseline|High RAS Activity|High RAS activity is defined in the protocol
1210567|NCT00264641|P2|Participant Flow|Low RAS Activity|Low RAS was defined as serum ACE and plasma angiotensinogen concentration in the lowest quartiles in the population combined with AT2 receptor genotype G
1210568|NCT00264641|P1|Participant Flow|High RAS Activity|High RAS was defined as serum ACE and plasma angiotensinogen concentration in the highest quartiles in the population combined with AT2 receptor genotype A
1210569|NCT00264641|O1|Outcome|All Study Participants|From a screening population ten subjects with high RAS activity – defined as serum ACE and plasma angiotensinogen concentrations in the highest quartile in the population combined with presence of AT2 receptor genotype A corresponding to low expression of the receptor (maximum stimulation via the AT1 receptor) – were selected And 10 males with low RAS activity – defined as serum ACE and plasma angiotensinogen concentrations in the lowest quartile in the population combined with the presence of AT2 receptor genotype G corresponding to high expression of the receptor (58) (minimum stimulation via the AT1 receptor) were selected
1210570|NCT00264641|E2|Reported Event|Low RAS Activity|Low RAS activity is described in the protocol
1210571|NCT00264641|E1|Reported Event|High RAS Activity|High RAS activity is described in the protocol
1210572|NCT00264576|B3|Baseline|Total|Total of all reporting groups
1210573|NCT00264576|B2|Baseline|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
1210574|NCT00264576|B1|Baseline|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
1210575|NCT00264576|P2|Participant Flow|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
1210576|NCT00264576|P1|Participant Flow|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
1210577|NCT00264576|O2|Outcome|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
1210578|NCT00264576|O1|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
1210579|NCT00264576|O2|Outcome|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
1210580|NCT00264576|O1|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
1210581|NCT00264576|O2|Outcome|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
1210582|NCT00264576|O1|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
1210583|NCT00264576|O2|Outcome|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
1210589|NCT00264576|O2|Outcome|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
1210590|NCT00264576|O1|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
1210591|NCT00264576|O2|Outcome|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
1210592|NCT00264576|O1|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
1210596|NCT00264550|B4|Baseline|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210597|NCT00264550|B3|Baseline|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210598|NCT00264550|B2|Baseline|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210599|NCT00264550|B1|Baseline|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210600|NCT00264550|P4|Participant Flow|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210601|NCT00264550|P3|Participant Flow|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210602|NCT00264550|P2|Participant Flow|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210603|NCT00264550|P1|Participant Flow|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210604|NCT00264550|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
1210605|NCT00264550|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210606|NCT00264550|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210607|NCT00264550|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210608|NCT00264550|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210609|NCT00264550|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
1210610|NCT00264550|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210685|NCT00264381|B1|Baseline|Ibuprofen 800 mg Tid|"Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days~+ additional 7 days of same therapy based on result of ultrasound at day 7"
1210687|NCT00264381|P1|Participant Flow|Ibuprofen 800 mg Tid|"Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days~+ additional 7 days of same therapy based on result of ultrasound at day 7"
1210611|NCT00264550|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210612|NCT00264550|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210613|NCT00264550|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210614|NCT00264550|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
1210615|NCT00264550|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210616|NCT00264550|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210617|NCT00264550|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210618|NCT00264550|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210619|NCT00264550|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
1210620|NCT00264550|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210621|NCT00264550|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210622|NCT00264550|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210623|NCT00264550|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210624|NCT00264550|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
1210625|NCT00264550|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210681|NCT00264498|E2|Reported Event|Experimental|Gefitinib
1210626|NCT00264550|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1214613|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
1210627|NCT00264550|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210628|NCT00264550|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210629|NCT00264550|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
1210630|NCT00264550|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210631|NCT00264550|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210632|NCT00264550|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210633|NCT00264550|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210634|NCT00264550|E3|Reported Event|Group 3: Golimumab 50 and 100 mg SC Injections|Participants who were treated with golimumab and received at least one injection of both golimumab 50 mg and golimumab 100 mg during the study. Participants also received either methotrexate or placebo capsules throughout the study.
1210635|NCT00264550|E2|Reported Event|Group 2: Golimumab 100 mg SC Injections Only|Participants who were treated with golimumab and received golimumab 100 mg injections only during the study. Participants also received either methotrexate or placebo capsules throughout the study.
1210636|NCT00264550|E1|Reported Event|Group 1: Golimumab 50 mg SC Injections Only|Participants who were treated with golimumab and received golimumab 50 mg injections only during the study. Participants also received methotrexate capsules throughout the study.
1210637|NCT00264537|B5|Baseline|Total|Total of all reporting groups
1210638|NCT00264537|B4|Baseline|Group 4: Golimumab 100 mg + Methotrexate|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210639|NCT00264537|B3|Baseline|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210640|NCT00264537|B2|Baseline|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate – Dr’s discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210641|NCT00264537|B1|Baseline|Group 1: Placebo + Methotrexate|Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab – Dr’s discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210642|NCT00264537|P4|Participant Flow|Group 4: Golimumab 100 mg + Methotrexate|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210682|NCT00264498|E1|Reported Event|Active Comparator|Gemcitabine + Carboplatin
1210643|NCT00264537|P3|Participant Flow|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210800|NCT00264004|O3|Outcome|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
1210644|NCT00264537|P2|Participant Flow|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate – Dr’s discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210645|NCT00264537|P1|Participant Flow|Group 1: Placebo + Methotrexate|Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab – Dr’s discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210646|NCT00264537|O5|Outcome|Combined: Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
1210647|NCT00264537|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210648|NCT00264537|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210649|NCT00264537|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate – Dr’s discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210650|NCT00264537|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab – Dr’s discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210651|NCT00264537|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
1210652|NCT00264537|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210653|NCT00264537|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210654|NCT00264537|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate – Dr’s discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210655|NCT00264537|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab – Dr’s discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210656|NCT00264537|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
1210657|NCT00264537|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate (MTX)|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210658|NCT00264537|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210683|NCT00264381|B3|Baseline|Total|Total of all reporting groups
1210791|NCT00264004|O4|Outcome|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
1214062|NCT00252733|B2|Baseline|Placebo|Placebo Comparator
1210686|NCT00264381|P2|Participant Flow|Dalteparin 200 U/kg Then 10,000 U Daily|"Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days~+ additional 7 days of same therapy based on results of ultrasound at day 7"
1210801|NCT00264004|O2|Outcome|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
1210802|NCT00264004|O1|Outcome|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
1210659|NCT00264537|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate – Dr’s discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210660|NCT00264537|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab – Dr’s discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210661|NCT00264537|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
1210662|NCT00264537|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210663|NCT00264537|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210664|NCT00264537|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate – Dr’s discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210665|NCT00264537|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab – Dr’s discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210666|NCT00264537|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
1210667|NCT00264537|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210668|NCT00264537|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210669|NCT00264537|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate – Dr’s discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210670|NCT00264537|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab – Dr’s discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
1210671|NCT00264537|E3|Reported Event|Group C: Golimumab 50 and 100 mg SC Injections|Participants who were treated with golimumab and received at least one injection of both golimumab 50 mg and golimumab 100 mg during the study. Participants also received either methotrexate or placebo capsules throughout the study. Participants were included from Group 1, Group 2, Group 3 and Group 4, who received Golimumab 50 mg and 100 mg SC Injections.
1210672|NCT00264537|E2|Reported Event|Group B: Golimumab 100 mg SC Injections Only|Participants who were treated with golimumab and received golimumab 100 mg injections only during the study. Participants also received either methotrexate or placebo capsules throughout the study. Participants were included from Group 1, Group 2 and Group 4, who received only Golimumab 100 mg SC Injections.
1210673|NCT00264537|E1|Reported Event|Group A: Golimumab 50 mg SC Injections Only|Participants who were treated with golimumab and received golimumab 50 mg injections only during the study. Participants also received methotrexate capsules throughout the study. Participants were included from Group 1 and Group 3, who received only Golimumab 50 mg SC Injections.
1210674|NCT00264498|B3|Baseline|Total|Total of all reporting groups
1210675|NCT00264498|B2|Baseline|Experimental|Gefitinib
1210676|NCT00264498|B1|Baseline|Active Comparator|Gemcitabine + Carboplatin
1210677|NCT00264498|P2|Participant Flow|Experimental|Gefitinib
1210678|NCT00264498|P1|Participant Flow|Active Comparator|Gemcitabine + Carboplatin
1210679|NCT00264498|O2|Outcome|Experimental|Gefitinib
1210680|NCT00264498|O1|Outcome|Active Comparator|Gemcitabine + Carboplatin
1210688|NCT00264381|O2|Outcome|Dalteparin 200 U/kg Then 10,000 U Daily|"Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days~+ additional 7 days of same therapy based on results of ultrasound at day 7"
1210689|NCT00264381|O1|Outcome|Ibuprofen 800 mg Tid|"Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days~+ additional 7 days of same therapy based on result of ultrasound at day 7"
1210690|NCT00264381|O2|Outcome|Dalteparin 200 U/kg Then 10,000 U Daily|"Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days~+ additional 7 days of same therapy based on results of ultrasound at day 7"
1210691|NCT00264381|O1|Outcome|Ibuprofen 800 mg Tid|"Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days~+ additional 7 days of same therapy based on result of ultrasound at day 7"
1210692|NCT00264381|O2|Outcome|Dalteparin 200 U/kg Then 10,000 U Daily|"Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days~+ additional 7 days of same therapy based on results of ultrasound at day 7"
1210693|NCT00264381|O1|Outcome|Ibuprofen 800 mg Tid|"Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days~+ additional 7 days of same therapy based on result of ultrasound at day 7"
1210694|NCT00264381|O2|Outcome|Dalteparin 200 U/kg Then 10,000 U Daily|"Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days~+ additional 7 days of same therapy based on results of ultrasound at day 7"
1210695|NCT00264381|O1|Outcome|Ibuprofen 800 mg Tid|"Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days~+ additional 7 days of same therapy based on result of ultrasound at day 7"
1210696|NCT00264381|E2|Reported Event|Dalteparin 200 U/kg Then 10,000 U Daily|"Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days~+ additional 7 days of same therapy based on results of ultrasound at day 7"
1210697|NCT00264381|E1|Reported Event|Ibuprofen 800 mg Tid|"Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days~+ additional 7 days of same therapy based on result of ultrasound at day 7"
1210698|NCT00264303|B3|Baseline|Total|Total of all reporting groups
1210699|NCT00264303|B2|Baseline|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
1210700|NCT00264303|B1|Baseline|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
1210701|NCT00264303|P2|Participant Flow|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
1210702|NCT00264303|P1|Participant Flow|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
1210703|NCT00264303|O2|Outcome|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
1210704|NCT00264303|O1|Outcome|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
1210705|NCT00264303|O2|Outcome|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
1210706|NCT00264303|O1|Outcome|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
1210707|NCT00264303|O2|Outcome|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
1210708|NCT00264303|O1|Outcome|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
1210709|NCT00264303|O2|Outcome|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
1210710|NCT00264303|O1|Outcome|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
1210711|NCT00264303|O2|Outcome|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
1210712|NCT00264303|O1|Outcome|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
1210713|NCT00264303|O2|Outcome|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
1210714|NCT00264303|O1|Outcome|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
1210715|NCT00264303|E2|Reported Event|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
1210716|NCT00264303|E1|Reported Event|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
1210717|NCT00264290|B3|Baseline|Total|Total of all reporting groups
1210718|NCT00264290|B2|Baseline|Valganciclovir|"900mg PO qd~Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone."
1210719|NCT00264290|B1|Baseline|Placebo|Placebo PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.
1210720|NCT00264290|P2|Participant Flow|Valganciclovir|"900mg PO qd~Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone."
1210721|NCT00264290|P1|Participant Flow|Placebo|Placebo PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone.
1210722|NCT00264290|O2|Outcome|Valganciclovir|"900mg PO qd~Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone."
1210723|NCT00264290|O1|Outcome|Placebo|placebo PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.
1210724|NCT00264290|E2|Reported Event|Valganciclovir|"900mg PO qd~Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone."
1210725|NCT00264290|E1|Reported Event|Placebo|Placebo PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.
1210782|NCT00264004|B5|Baseline|Total|Total of all reporting groups
1210783|NCT00264004|B4|Baseline|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
1210784|NCT00264004|B3|Baseline|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
1210726|NCT00264238|B1|Baseline|Memantine Open Label|"All subjects knowingly received (open label) memantine for up to 12 weeks with a target dose of 10 mg twice a day (20mg/d) taken orally.~Memantine: pharmacological dosing of memantine as adjunctive therapy for treatment-resistant obsessive-compulsive disorder"
1210727|NCT00264238|P1|Participant Flow|Memantine Open Label|"All subjects knowingly received (open label) memantine for up to 12 weeks with a target dose of 10 mg twice a day (20mg/d) taken orally.~Memantine: pharmacological dosing of memantine as adjunctive therapy for treatment-resistant obsessive-compulsive disorder"
1210728|NCT00264238|O2|Outcome|Non-Responders: Memantine Open Label|Participants who did not respond to memantine as adjunctive therapy
1210803|NCT00264004|O4|Outcome|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
1210804|NCT00264004|O3|Outcome|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
1210729|NCT00264238|O1|Outcome|Responders: Memantine Open Label|"Participants who respond to memantine as adjunctive therapy; that is, Y-BOCS decrease of greater than or equal to 25% from baseline and a CGI0I rating of much or very much improved."
1210730|NCT00264238|O2|Outcome|Non-Responders: Memantine Open Label|Participants who did not respond to memantine as adjunctive therapy
1210731|NCT00264238|O1|Outcome|Responders: Memantine Open Label|"Participants who respond to memantine as adjunctive therapy defined as Y-BOCS decrease of greater than or equal to 25% from baseline and a CGI-I rating of much or very much improved."
1210732|NCT00264238|E1|Reported Event|Memantine Open Label|"All subjects knowingly received (open label) memantine for up to 12 weeks with a target dose of 10 mg twice a day (20mg/d) taken orally.~Memantine: pharmacological dosing of memantine as adjunctive therapy for treatment-resistant obsessive-compulsive disorder"
1210733|NCT00264147|B6|Baseline|Total|Total of all reporting groups
1210734|NCT00264147|B5|Baseline|Etoricoxib 90 mg|Treatment I: Etoricoxib 90 mg orally once daily
1210735|NCT00264147|B4|Baseline|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
1210736|NCT00264147|B3|Baseline|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
1210737|NCT00264147|B2|Baseline|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
1210738|NCT00264147|B1|Baseline|Placebo|Treatment I: Placebo orally once daily
1210739|NCT00264147|P6|Participant Flow|Diclofenac 150 mg (Treatment II)|Treatment II: Diclofenac 75 mg orally twice daily
1210740|NCT00264147|P5|Participant Flow|Etoricoxib 90 mg|Treatment I and II: Etoricoxib 90 mg orally once daily
1210741|NCT00264147|P4|Participant Flow|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
1210742|NCT00264147|P3|Participant Flow|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
1210743|NCT00264147|P2|Participant Flow|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
1210744|NCT00264147|P1|Participant Flow|Placebo|Treatment I: Placebo orally once daily
1210745|NCT00264147|O5|Outcome|Etoricoxib 90 mg|Treatment I: Etoricoxib 90 mg orally once daily
1210746|NCT00264147|O4|Outcome|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
1210747|NCT00264147|O3|Outcome|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
1210748|NCT00264147|O2|Outcome|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
1210749|NCT00264147|O1|Outcome|Placebo|Treatment I: Placebo orally once daily
1210750|NCT00264147|O5|Outcome|Etoricoxib 90 mg|Treatment I: Etoricoxib 90 mg orally once daily
1210751|NCT00264147|O4|Outcome|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
1210752|NCT00264147|O3|Outcome|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
1210753|NCT00264147|O2|Outcome|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
1210754|NCT00264147|O1|Outcome|Placebo|Treatment I: Placebo orally once daily
1210755|NCT00264147|O5|Outcome|Etoricoxib 90 mg|Treatment I: Etoricoxib 90 mg orally once daily
1210756|NCT00264147|O4|Outcome|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
1210757|NCT00264147|O3|Outcome|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
1210758|NCT00264147|O2|Outcome|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
1210759|NCT00264147|O1|Outcome|Placebo|Treatment I: Placebo orally once daily
1210760|NCT00264147|O5|Outcome|Etoricoxib 90 mg|Treatment I: Etoricoxib 90 mg orally once daily
1210761|NCT00264147|O4|Outcome|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
1210762|NCT00264147|O3|Outcome|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
1210763|NCT00264147|O2|Outcome|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
1210764|NCT00264147|O1|Outcome|Placebo|Treatment I: Placebo orally once daily
1210765|NCT00264147|O5|Outcome|Etoricoxib 90 mg|Treatment I: Etoricoxib 90 mg orally once daily
1210766|NCT00264147|O4|Outcome|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
1210767|NCT00264147|O3|Outcome|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
1210768|NCT00264147|O2|Outcome|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
1210769|NCT00264147|O1|Outcome|Placebo|Treatment I: Placebo orally once daily
1210770|NCT00264147|O5|Outcome|Etoricoxib 90 mg|Treatment I: Etoricoxib 90 mg orally once daily
1210771|NCT00264147|O4|Outcome|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
1210772|NCT00264147|O3|Outcome|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
1210773|NCT00264147|O2|Outcome|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
1210774|NCT00264147|O1|Outcome|Placebo|Treatment I: Placebo orally once daily
1210775|NCT00264147|E7|Reported Event|Diclofenac 150 mg Treatment II Period|Treatment II: Diclofenac 75 mg orally twice daily
1210776|NCT00264147|E6|Reported Event|Etoricoxib 90 mg Treatment II Period|Treatment II: Etoricoxib 90 mg orally once daily
1210777|NCT00264147|E5|Reported Event|Etoricoxib 90 mg Treatment I Period|Treatment I: Etoricoxib 90 mg orally once daily
1210778|NCT00264147|E4|Reported Event|Etoricoxib 60 mg Treatment I Period|Treatment I: Etoricoxib 60 mg orally once daily
1210779|NCT00264147|E3|Reported Event|Etoricoxib 30 mg Treatment I Period|Treatment I: Etoricoxib 30 mg orally once daily
1210780|NCT00264147|E2|Reported Event|Etoricoxib 10 mg Treatment I Period|Treatment I: Etoricoxib 10 mg orally once daily
1210781|NCT00264147|E1|Reported Event|Placebo Treatment I Period|Treatment I: Placebo orally once daily
1210792|NCT00264004|O3|Outcome|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
1210793|NCT00264004|O2|Outcome|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
1210794|NCT00264004|O1|Outcome|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
1210795|NCT00264004|O4|Outcome|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
1210796|NCT00264004|O3|Outcome|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
1210797|NCT00264004|O2|Outcome|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
1210798|NCT00264004|O1|Outcome|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
1210799|NCT00264004|O4|Outcome|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
1210812|NCT00264004|E3|Reported Event|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
1210813|NCT00264004|E2|Reported Event|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
1210814|NCT00264004|E1|Reported Event|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
1210815|NCT00263887|B3|Baseline|Total|Total of all reporting groups
1210816|NCT00263887|B2|Baseline|Placebo|
1210817|NCT00263887|B1|Baseline|Prolastin (60 mg/kg Body Weight)|
1210818|NCT00263887|P2|Participant Flow|Placebo|
1210819|NCT00263887|P1|Participant Flow|Prolastin (60 mg/kg Body Weight)|
1210820|NCT00263887|O2|Outcome|Placebo|
1210821|NCT00263887|O1|Outcome|Prolastin (60 mg/kg Body Weight)|
1210822|NCT00263887|E2|Reported Event|Placebo|
1210823|NCT00263887|E1|Reported Event|Prolastin (60 mg/kg Body Weight)|
1210824|NCT00263757|B3|Baseline|Total|Total of all reporting groups
1210825|NCT00263757|B2|Baseline|Usual Care|Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
1210826|NCT00263757|B1|Baseline|Therapeutic Positive Airway Pressure|Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
1210827|NCT00263757|P2|Participant Flow|Usual Care|Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
1210828|NCT00263757|P1|Participant Flow|Therapeutic Positive Airway Pressure|Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
1210829|NCT00263757|O2|Outcome|Usual Care|Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
1210830|NCT00263757|O1|Outcome|Therapeutic Positive Airway Pressure|Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
1210831|NCT00263757|O2|Outcome|Usual Care|Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
1210832|NCT00263757|O1|Outcome|Therapeutic Positive Airway Pressure|Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
1210833|NCT00263757|O2|Outcome|Usual Care|Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
1210834|NCT00263757|O1|Outcome|Therapeutic Positive Airway Pressure|Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
1210835|NCT00263757|E2|Reported Event|Usual Care|Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
1210836|NCT00263757|E1|Reported Event|Therapeutic Positive Airway Pressure|Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
1210837|NCT00263666|B3|Baseline|Total|Total of all reporting groups
1210838|NCT00263666|B2|Baseline|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210839|NCT00263666|B1|Baseline|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210840|NCT00263666|P2|Participant Flow|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210841|NCT00263666|P1|Participant Flow|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210842|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210843|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210844|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210845|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210846|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210847|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210848|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210849|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210850|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210851|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210852|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210853|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210854|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210855|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210856|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210857|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210858|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210859|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210860|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1214614|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
1210861|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210862|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210863|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210864|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210865|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210866|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210867|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210868|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210869|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210870|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210871|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210872|NCT00263666|O1|Outcome|Rotarix Group 1|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210873|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210874|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210875|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210876|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210877|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210878|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210879|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210880|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210881|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210882|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210883|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210884|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210885|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210886|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210887|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210888|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210889|NCT00263666|E2|Reported Event|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210890|NCT00263666|E1|Reported Event|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
1210892|NCT00263328|B3|Baseline|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210893|NCT00263328|B2|Baseline|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211112|NCT00262925|P1|Participant Flow|Treatment (Chemotherapy, Enzyme Inhibitor Therapy)|"INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM ; oral dexamethasone ; and alemtuzumab SC.~CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.~CYTOREDUCTION THERAPY: Patients receive vincristine IV and methotrexate IV; leucovorin calcium IV; and oral dexamethasone.~MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone."
1210894|NCT00263328|B1|Baseline|Tofacitinib|Participants received tacrolimus BID, administered according to standard institutional practice. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210895|NCT00263328|P3|Participant Flow|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210896|NCT00263328|P2|Participant Flow|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210897|NCT00263328|P1|Participant Flow|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months posttransplant. Thereafter, steroids may have been discontinued at the investigator’s discretion.
1210898|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210899|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210900|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210901|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210902|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210903|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211171|NCT00262743|O1|Outcome|Phase II Polyphenon E|2000mg twice daily for 6 months
1210904|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210905|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210906|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210907|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210908|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210909|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210910|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210930|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211396|NCT00262041|O1|Outcome|MenACWY-CRM(Ad+)|Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
1210911|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210912|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210913|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210914|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210915|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210916|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210917|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210918|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210919|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210920|NCT00263328|O2|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211397|NCT00262041|O2|Outcome|MenACWY-PS|Subjects received one single dose of the MenACWY polysaccharide vaccine.
1210921|NCT00263328|O1|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator’s discretion.
1211135|NCT00262847|B3|Baseline|Arm III (Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-throughout therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks."
1211136|NCT00262847|B2|Baseline|Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-initiation therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
1210922|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210923|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210924|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210925|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210926|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210927|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210928|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210929|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211111|NCT00262925|B1|Baseline|Treatment (Chemotherapy, Enzyme Inhibitor Therapy)|"INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM; oral dexamethasone; and alemtuzumab SC on days 1, 4, and 7.~CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.~CYTOREDUCTION THERAPY: Patients receive vincristine IV and oral methotrexate IV; leucovorin calcium IV; and oral dexamethasone.~MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone."
1210931|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211172|NCT00262743|O1|Outcome|Phase II Polyphenon E|2000mg twice daily for 6 months
1210932|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210933|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210934|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210935|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210936|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210937|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210938|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210939|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210940|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211137|NCT00262847|B1|Baseline|Arm I (Placebo, Paclitaxel, Carboplatin)|"Control therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
1211138|NCT00262847|P3|Participant Flow|Arm III (Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-throughout therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks."
1211173|NCT00262743|E1|Reported Event|Phase II Polyphenon E|2000mg orally twice daily for 6 months
1211206|NCT00262600|O3|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
1210941|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210942|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210943|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210944|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210945|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210946|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210947|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210948|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210949|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210977|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210950|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210951|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210952|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210953|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210954|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210955|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210956|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210957|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210958|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211076|NCT00262964|P2|Participant Flow|NAFLD - Fenofibrate|Subjects diagnosed with NAFLD were randomized to an eight week regimen of fenofibrate
1211077|NCT00262964|P1|Participant Flow|NAFLD - Niacin|subjects diagnosed with NAFLD were randomized to a sixteen week regimen of niacin.
1211078|NCT00262964|O2|Outcome|NAFLD - Niacin|subjects with elevated levels of intra-hepatic trigleceride given a 16 week course of niacin.
1211079|NCT00262964|O1|Outcome|NAFLD - Fenofibrate|Subjects with elevated intrahepatic triglyceride given an eight week course of fenofibrate
1211080|NCT00262964|O2|Outcome|NAFLD - Niacin|subjects given niacin for 16 weeks
1214577|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
1210959|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210960|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210961|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210962|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210963|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210964|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210965|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210966|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210967|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211081|NCT00262964|O1|Outcome|NAFLD - Fenofibrate|Subjects diagnosed with NAFLD were randomized to an eight week regimen of fenofibrate
1211082|NCT00262964|O2|Outcome|NAFLD - Niacin|subjects given niacin for 16 weeks
1211083|NCT00262964|O1|Outcome|NAFLD - Fenofibrate|Subjects diagnosed with NAFLD were randomized to an eight week regimen of fenofibrate
1211084|NCT00262964|O2|Outcome|NAFLD - Niacin|subjects given Niacin for 16 weeks
1211085|NCT00262964|O1|Outcome|NAFLD - Fenofibrate|Subjects diagnosed with NAFLD were randomized to an eight week regimen of fenofibrate
1211398|NCT00262041|O1|Outcome|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
1210968|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210969|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210970|NCT00263328|O2|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210971|NCT00263328|O1|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210972|NCT00263328|O2|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210973|NCT00263328|O1|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210974|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210975|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210976|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211086|NCT00262964|O2|Outcome|NAFLD - Niacin|subjects with elevated levels of intra-hepatic trigleceride (>10% signal by MR spectroscopy) given a 16 week course of niacin
1211087|NCT00262964|O1|Outcome|NAFLD - Fenofibrate|Subjects with intrahepatic triglyceride signal greater than 10% per MR spectroscopy receiving fenofibrate for eight weeks.
1211088|NCT00262964|O2|Outcome|NAFLD - Niacin|subjects with elevated levels of intra-hepatic trigleceride given a 16 week course of niacin
1210978|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210979|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210980|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210981|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210982|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210983|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210984|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210985|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210986|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211089|NCT00262964|O1|Outcome|NAFLD - Fenofibrate|Subjects with intrahepatic triglyceride signal greater than 10% per MR spectroscopy given an eight week course of fenofibrate
1211090|NCT00262964|O2|Outcome|NAFLD - Niacin|subjects given Niacin for 16 weeks
1211091|NCT00262964|O1|Outcome|NAFLD - Fenofibrate|Subjects diagnosed with NAFLD were randomized to an eight week regimen of fenofibrate
1211092|NCT00262964|O2|Outcome|NAFLD - Niacin|subjects given niacin for 16 weeks
1211093|NCT00262964|O1|Outcome|NAFLD - Fenofibrate|Subjects diagnosed with NAFLD were randomized to an eight week regimen of fenofibrate
1211094|NCT00262964|O2|Outcome|Controls|subjects with normal intrahepatic triglyceride levels
1210987|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210988|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210989|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210990|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210991|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210992|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210993|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210994|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210995|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211095|NCT00262964|O1|Outcome|NAFLD|Subjects with elevated intrahepatic triglyceride (>10% signal compared to H2O) measured by MR Spectroscopy.
1211096|NCT00262964|O2|Outcome|Controls|subjects with normal levels of intra-hepatic trigleceride
1211097|NCT00262964|O1|Outcome|NAFLD|Subjects with intrahepatic triglyceride signal greater than 10% per MR spectroscopy
1211098|NCT00262964|O2|Outcome|Controls|subjects with normal levels of intra-hepatic trigleceride
1211099|NCT00262964|O1|Outcome|NAFLD|Subjects with intrahepatic triglyceride content greater than 10% per Magnetic Resonance Spectroscopy
1211100|NCT00262964|O2|Outcome|Controls|subjects with normal intra-hepatic triglyceride levels
1210996|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210997|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210998|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1210999|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211000|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211001|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211002|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211003|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211004|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211101|NCT00262964|O1|Outcome|NAFLD|subjects with intra-hepatic triglyceride content greater than 10%.
1211102|NCT00262964|E4|Reported Event|Controls|subjects with normal hepatic triglyceride.
1211103|NCT00262964|E3|Reported Event|NAFLD - no Drug|subjects with elevated hepatic triglyceride who did not receive any drug intervention
1211104|NCT00262964|E2|Reported Event|NAFLD - Niacin|subjects with intra-hepatic triglyceride signal greater than 10% placed on daily niacin for 16 weeks. The dose of medication will be gradually increased according to the protocol of most clinical trials (59): 500 mg/day during wk 1, 1000 mg/day during wk 2, 1500 mg/day during wks 3, and 2000mg/day during wks 4-16.
1211005|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211006|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211007|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211008|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211009|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211010|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211011|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211012|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211013|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211105|NCT00262964|E1|Reported Event|NAFLD - Fenofibrate|Subjects diagnosed with NAFLD were randomized to an weight week regimen of fenofibrate
1211106|NCT00262951|B1|Baseline|Pancreatic Adenocarcinoma Patients|Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery). Patients were given one cycle of continuous infusion 5-FU (175 mg/m^2/day for 38 days), weekly cisplatin 30 mg/m^2 over 1 hour, and IFN-alpha-2b (3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks) with radiation therapy (5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday –Friday, for 5½ weeks) followed by two cycles of bolus 5-FU alone (500 mg/m^2 weekly * 6, followed by 2 weeks of rest).
1211014|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211015|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211016|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211017|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211018|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211019|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211020|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211021|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211022|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211107|NCT00262951|P1|Participant Flow|Pancreatic Adenocarcinoma Patients|Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery). Patients were given one cycle of continuous infusion 5-FU (175 mg/m^2/day for 38 days), weekly cisplatin 30 mg/m^2 over 1 hour, and IFN-alpha-2b (3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks) with radiation therapy (5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday –Friday, for 5½ weeks) followed by two cycles of bolus 5-FU alone (500 mg/m^2 weekly * 6, followed by 2 weeks of rest).
1211248|NCT00262522|O4|Outcome|LPV/r 400/100 mg BID SGC (Through Week 8)|lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
1211023|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211024|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211025|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211026|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211027|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211028|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211029|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211030|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211031|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211108|NCT00262951|O1|Outcome|Pancreatic Adenocarcinoma Patients|Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery). Patients will be given one cycle of continuous infusion 5-FU (175 mg/m^2/day for 38 days), weekly cisplatin 30 mg/m^2 over 1 hour, and IFN-alpha-2b (3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks) with radiation therapy (5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday -Friday, for 5½ weeks) followed by two cycles of bolus 5-FU alone (500 mg/m^2 weekly * 6, followed by 2 weeks of rest).
1211249|NCT00262522|O3|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
1214578|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
1211032|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211033|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211034|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211035|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211036|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211037|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211038|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211039|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211040|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211109|NCT00262951|O1|Outcome|Pancreatic Adenocarcinoma Patients|Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery). Patients will be given one cycle of continuous infusion 5-FU (175 mg/m^2/day for 38 days), weekly cisplatin 30 mg/m^2 over 1 hour, and IFN-alpha-2b (3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks) with radiation therapy (5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday -Friday, for 5½ weeks) followed by two cycles of bolus 5-FU alone (500 mg/m^2 weekly * 6, followed by 2 weeks of rest).
1211250|NCT00262522|O2|Outcome|LPV/r 800/200 mg QD SGC (Through Week 8)|lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
1211041|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211042|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211043|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211044|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211045|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211046|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211047|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211048|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211049|NCT00263328|E3|Reported Event|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211110|NCT00262951|E1|Reported Event|Pancreatic Adenocarcinoma Patients|Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery). Patients were given one cycle of continuous infusion 5-FU (175 mg/m^2/day for 38 days), weekly cisplatin 30 mg/m^2 over 1 hour, and IFN-alpha-2b (3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks) with radiation therapy (5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday –Friday, for 5½ weeks) followed by two cycles of bolus 5-FU alone (500 mg/m^2 weekly * 6, followed by 2 weeks of rest).
1211251|NCT00262522|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
1211050|NCT00263328|E2|Reported Event|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211051|NCT00263328|E1|Reported Event|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
1211052|NCT00263211|B3|Baseline|Total|Total of all reporting groups
1211053|NCT00263211|B2|Baseline|Observation Only|Observation by treating physician
1211054|NCT00263211|B1|Baseline|Plavix and Aspirin|Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
1211055|NCT00263211|P2|Participant Flow|Observation Only|Observation by treating physician
1211056|NCT00263211|P1|Participant Flow|Plavix and Aspirin|Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
1211057|NCT00263211|O2|Outcome|Observation Only|Observation by treating physician
1211058|NCT00263211|O1|Outcome|Plavix and Aspirin|"Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.~Plavix"
1211059|NCT00263211|O2|Outcome|Observation Only|
1211060|NCT00263211|O1|Outcome|Plavix and Aspirin|
1211061|NCT00263211|O2|Outcome|Observation Only|Observation by treating physician
1211062|NCT00263211|O1|Outcome|Plavix and Aspirin|Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
1211063|NCT00263211|O2|Outcome|Observation Only|Observation by treating physician
1211064|NCT00263211|O1|Outcome|Plavix and Aspirin|Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
1211065|NCT00263211|O2|Outcome|Observation Only|Observation by treating physician
1211066|NCT00263211|O1|Outcome|Plavix and Aspirin|Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
1211067|NCT00263211|O2|Outcome|Observation Only|Observation by treating physician
1211068|NCT00263211|O1|Outcome|Plavix and Aspirin|Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
1211069|NCT00263211|E2|Reported Event|Observation Only|Observation by treating physician
1211070|NCT00263211|E1|Reported Event|Plavix and Aspirin|Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
1211071|NCT00262964|B3|Baseline|Total|Total of all reporting groups
1211072|NCT00262964|B2|Baseline|NAFLD|Subjects diagnosed with Non-Alcoholic Fatty Liver Disease(NAFLD). Determination of NAFLD was by magnetic resonance spectroscopy of intra-hepatic triglyceride content (defined by greater than 10% lipid to water signal). This group included subjects later randomized into the NAFLD-Niacin, NAFLD-Fenofibrate, and NAFLD-no intervention arms.
1211073|NCT00262964|B1|Baseline|Controls|Subjects with normal intra-hepatic triglyceride content (defined by less than 10% lipid to water signal in magnetic resonance spectroscopy).
1211074|NCT00262964|P4|Participant Flow|NAFLD - no Drug|Subjects with elevated intrahepatic triglyceride (IHTG) levels (>10%) who were measured only once (baseline). These subjects did not undergo drug therapy, in contrast to the NAFLD-niacin and NAFLD-fenofibrate group subjects. IHTG was measured using magnetic resonance spectroscopy and defined as the extrapolated ratio of triglyceride signal to water signal at time t = 0.
1211075|NCT00262964|P3|Participant Flow|Controls|Subjects with normal intrahepatic fat triglyceride(IHTG) levels (<10%). IHTG was measured using magnetic resonance spectroscopy and defined as the extrapolated ratio of triglyceride signal to water signal at time t = 0.
1211113|NCT00262925|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor Therapy)|"Detailed Description Section~INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM; oral dexamethasone; and alemtuzumab SC on days 1, 4, and 7.~CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.~CYTOREDUCTION THERAPY: Patients receive vincristine IV and oral methotrexate IV; leucovorin calcium IV; and oral dexamethasone.~MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone.~alemtuzumab: Given subcutaneously~asparaginase: Given IM~methotrexate: Given IV or orally~dexamethasone: Given orally~leucovorin calcium: Given IV~mercaptopurine tablet: Given orally~vincristine sulfate: Given IV~laboratory biomarker analysis: Correlative studies"
1211114|NCT00262925|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor Therapy)|"INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM; oral dexamethasone; and alemtuzumab SC on days 1, 4, and 7.~CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.~CYTOREDUCTION THERAPY: Patients receive vincristine IV and oral methotrexate IV; leucovorin calcium IV; and oral dexamethasone.~MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone."
1211115|NCT00262925|E2|Reported Event|MOAD+Campath-Step 2|"Campath 10 mg dose~INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM; oral dexamethasone; and alemtuzumab SC.~CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.~CYTOREDUCTION THERAPY: Patients receive vincristine IV and oral methotrexate IV; leucovorin calcium IV; and oral dexamethasone.~MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone."
1211116|NCT00262925|E1|Reported Event|MOAD+Campath-Step 1|"Campath 5mg dose~INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM; oral dexamethasone; and alemtuzumab SC.~CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.~CYTOREDUCTION THERAPY: Patients receive vincristine IV and oral methotrexate IV; leucovorin calcium IV; and oral dexamethasone.~MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone."
1211117|NCT00262873|B1|Baseline|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
1211118|NCT00262873|P1|Participant Flow|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
1211119|NCT00262873|O1|Outcome|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
1211120|NCT00262873|O1|Outcome|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
1211121|NCT00262873|O1|Outcome|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
1211122|NCT00262873|O1|Outcome|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
1211123|NCT00262873|O1|Outcome|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
1211124|NCT00262873|O1|Outcome|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
1211125|NCT00262873|O1|Outcome|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
1211126|NCT00262873|O1|Outcome|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
1211127|NCT00262873|E1|Reported Event|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
1211128|NCT00262860|B1|Baseline|Bortezomib, Gemcitabine Hydrochloride|"bortezomib~gemcitabine hydrochloride~Bortezomib was administered at a dose of 1 mg/m2 on days 1, 4, 8,and 11 of a 21-day schedule. Gemcitabine was administered at a dose of 800 mg/m2 on days 1 and 8 of the same 21-day schedule."
1211129|NCT00262860|P1|Participant Flow|Bortezomib, Gemcitabine Hydrochloride|"bortezomib~gemcitabine hydrochloride~Bortezomib was administered at a dose of 1 mg/m2 on days 1, 4, 8,and 11 of a 21-day schedule. Gemcitabine was administered at a dose of 800 mg/m2 on days 1 and 8 of the same 21-day schedule."
1211130|NCT00262860|O1|Outcome|Bortezomib, Gemcitabine Hydrochloride|"bortezomib~gemcitabine hydrochloride~Bortezomib was administered at a dose of 1 mg/m2 on days 1, 4, 8,and 11 of a 21-day schedule. Gemcitabine was administered at a dose of 800 mg/m2 on days 1 and 8 of the same 21-day schedule."
1211131|NCT00262860|O1|Outcome|Bortezomib, Gemcitabine Hydrochloride|"bortezomib~gemcitabine hydrochloride~Bortezomib was administered at a dose of 1 mg/m2 on days 1, 4, 8,and 11 of a 21-day schedule. Gemcitabine was administered at a dose of 800 mg/m2 on days 1 and 8 of the same 21-day schedule."
1211132|NCT00262860|O1|Outcome|Bortezomib, Gemcitabine Hydrochloride|"bortezomib~gemcitabine hydrochloride~Bortezomib was administered at a dose of 1 mg/m2 on days 1, 4, 8,and 11 of a 21-day schedule. Gemcitabine was administered at a dose of 800 mg/m2 on days 1 and 8 of the same 21-day schedule."
1211252|NCT00262522|E2|Reported Event|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
1211133|NCT00262860|E1|Reported Event|Bortezomib, Gemcitabine Hydrochloride|"bortezomib~gemcitabine hydrochloride~Bortezomib was administered at a dose of 1 mg/m2 on days 1, 4, 8,and 11 of a 21-day schedule. Gemcitabine was administered at a dose of 800 mg/m2 on days 1 and 8 of the same 21-day schedule."
1211134|NCT00262847|B4|Baseline|Total|Total of all reporting groups
1211170|NCT00262743|O1|Outcome|Phase II Polyphenon E|2000mg twice daily for 6 months
1211139|NCT00262847|P2|Participant Flow|Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-initiation therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
1211140|NCT00262847|P1|Participant Flow|Arm I (Placebo, Paclitaxel, Carboplatin)|"Control therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
1211141|NCT00262847|O3|Outcome|Arm III (Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-throughout therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks."
1211142|NCT00262847|O2|Outcome|Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-initiation therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
1211143|NCT00262847|O1|Outcome|Arm I (Placebo, Paclitaxel, Carboplatin)|"Control therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
1211144|NCT00262847|O3|Outcome|Arm III (Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-throughout therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks."
1211145|NCT00262847|O2|Outcome|Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-initiation therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
1211146|NCT00262847|O1|Outcome|Arm I (Placebo, Paclitaxel, Carboplatin)|"Control therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
1211147|NCT00262847|O3|Outcome|Arm III (Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-throughout therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks."
1211148|NCT00262847|O2|Outcome|Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-initiation therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
1211149|NCT00262847|O1|Outcome|Arm I (Placebo, Paclitaxel, Carboplatin)|"Control therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
1211150|NCT00262847|E3|Reported Event|Arm III (Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-throughout therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks."
1211151|NCT00262847|E2|Reported Event|Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-initiation therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
1211152|NCT00262847|E1|Reported Event|Arm I (Placebo, Paclitaxel, Carboplatin)|"Control therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
1211153|NCT00262834|B3|Baseline|Total|Total of all reporting groups
1211154|NCT00262834|B2|Baseline|Tissue Only|Women who declined vorinostat but agreed to donate tissues for biomarker assessment, signed a separate informed consent and were enrolled as controls.
1211155|NCT00262834|B1|Baseline|Vorinostat|Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy).
1211156|NCT00262834|P2|Participant Flow|Tissue Only|Women who declined vorinostat but agreed to donate tissues for biomarker assessment, signed a separate informed consent and were enrolled as controls.
1211157|NCT00262834|P1|Participant Flow|Vorinostat|Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy).
1211158|NCT00262834|O2|Outcome|Tissue Only|Women who declined vorinostat but agreed to donate tissues for biomarker assessment, signed a separate informed consent and were enrolled as controls.
1211159|NCT00262834|O1|Outcome|Vorinostat|Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy).
1211160|NCT00262834|O2|Outcome|Tissue Only|Women who declined vorinostat but agreed to donate tissues for biomarker assessment, signed a separate informed consent and were enrolled as controls.
1212946|NCT00257686|O5|Outcome|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
1211161|NCT00262834|O1|Outcome|Vorinostat|Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy).
1211162|NCT00262834|O1|Outcome|Vorinostat|Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy).
1211163|NCT00262834|E1|Reported Event|Vorinostat|Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy).
1211164|NCT00262743|B3|Baseline|Total|Total of all reporting groups
1211165|NCT00262743|B2|Baseline|Phase II Polyphenon E|2000mg twice daily for 6 months
1211166|NCT00262743|B1|Baseline|Phase I Polyphenon E|Dose ranging from 400 to 1,800 mg orally twice daily for 6 months
1211167|NCT00262743|P2|Participant Flow|Phase II Polyphenon E|2000mg orally twice daily for 6 months
1211168|NCT00262743|P1|Participant Flow|Phase I Polyphenon E|Dose ranging from 400 to 1,800 mg orally twice a day for 6 months
1211169|NCT00262743|O1|Outcome|Phase II Polyphenon E|2000mg twice daily for 6 months
1211174|NCT00262730|B1|Baseline|Treatment Arm - All Subjects|"poly ICLC, temozolomide, radiation: radiation therapy~poly ICLC : 20 mcg/kg 3x each week (Maintenance cycles)~temozolomide : daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant)~radiation therapy : RT: 60 Gy (6 weeks) concomitant therapy"
1211175|NCT00262730|P1|Participant Flow|Treatment Arm - All Subjects|"poly ICLC, temozolomide, radiation: radiation therapy~poly ICLC : 20 mcg/kg 3x each week (Maintenance cycles)~temozolomide : daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant)~radiation therapy : RT: 60 Gy (6 weeks) concomitant therapy"
1211176|NCT00262730|O1|Outcome|Treatment Arm - All Subjects|"poly ICLC, temozolomide, radiation: radiation therapy~poly ICLC : 20 mcg/kg 3x each week (Maintenance cycles)~temozolomide : daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant)~radiation therapy : RT: 60 Gy (6 weeks) concomitant therapy"
1211177|NCT00262730|E1|Reported Event|Treatment Arm All Subjects|"poly ICLC, TMZ, RT: poly ICLC : 20 mcg/kg 3x each week (Maintenance cycles) TMX : daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant) RT : RT: 60 Gy (6 weeks) concomitant therapy~AEs Grades 4 with Attributions of Possible, probably or definitely related to TMZ AND poly-ICLI"
1211178|NCT00262639|B5|Baseline|Total|Total of all reporting groups
1211179|NCT00262639|B4|Baseline|High CIWAar Flumazenil/Gabapentin|
1211180|NCT00262639|B3|Baseline|High CIWAar Placebo|
1211181|NCT00262639|B2|Baseline|Low CIWAar Flumazenil/Gabapentin|
1211182|NCT00262639|B1|Baseline|Low CIWAar Placebo|
1211183|NCT00262639|P4|Participant Flow|High CIWAar Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
1211184|NCT00262639|P3|Participant Flow|High CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
1211185|NCT00262639|P2|Participant Flow|Low CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
1211186|NCT00262639|P1|Participant Flow|Low CIWA Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
1211187|NCT00262639|O4|Outcome|High CIWAar Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
1211188|NCT00262639|O3|Outcome|High CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
1211189|NCT00262639|O2|Outcome|Low CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
1211190|NCT00262639|O1|Outcome|Low CIWA Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
1211191|NCT00262639|O4|Outcome|High CIWAar Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
1211192|NCT00262639|O3|Outcome|High CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
1211193|NCT00262639|O2|Outcome|Low CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
1211194|NCT00262639|O1|Outcome|Low CIWA Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
1211253|NCT00262522|E1|Reported Event|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
1211195|NCT00262639|E4|Reported Event|High CIWAar Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
1211196|NCT00262639|E3|Reported Event|High CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
1211197|NCT00262639|E2|Reported Event|Low CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
1211198|NCT00262639|E1|Reported Event|Low CIWA Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
1211199|NCT00262600|B4|Baseline|Total|Total of all reporting groups
1211200|NCT00262600|B3|Baseline|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
1211201|NCT00262600|B2|Baseline|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
1211202|NCT00262600|B1|Baseline|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
1211203|NCT00262600|P3|Participant Flow|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
1211204|NCT00262600|P2|Participant Flow|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
1211205|NCT00262600|P1|Participant Flow|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
1211207|NCT00262600|O2|Outcome|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
1211208|NCT00262600|O1|Outcome|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
1211209|NCT00262600|O3|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
1211210|NCT00262600|O2|Outcome|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
1211211|NCT00262600|O1|Outcome|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
1211212|NCT00262600|O3|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
1211213|NCT00262600|O2|Outcome|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
1211214|NCT00262600|O1|Outcome|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
1211215|NCT00262600|O3|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
1211216|NCT00262600|O2|Outcome|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
1211217|NCT00262600|O1|Outcome|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
1211218|NCT00262600|O3|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
1211219|NCT00262600|O2|Outcome|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
1211220|NCT00262600|O1|Outcome|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
1211221|NCT00262600|O3|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
1211222|NCT00262600|O2|Outcome|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
1211223|NCT00262600|O1|Outcome|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
1211224|NCT00262600|E3|Reported Event|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
1211225|NCT00262600|E2|Reported Event|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
1211226|NCT00262600|E1|Reported Event|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
1211227|NCT00262522|B5|Baseline|Total|Total of all reporting groups
1211228|NCT00262522|B4|Baseline|LPV/r 400/100 mg BID SGC (Through Week 8)|lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
1211229|NCT00262522|B3|Baseline|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
1211230|NCT00262522|B2|Baseline|LPV/r 800/200 mg QD SGC (Through Week 8)|lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
1211231|NCT00262522|B1|Baseline|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
1211232|NCT00262522|P4|Participant Flow|LPV/r 400/100 mg BID SGC (Through Week 8)|lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
1211233|NCT00262522|P3|Participant Flow|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
1211234|NCT00262522|P2|Participant Flow|LPV/r 800/200 mg QD SGC (Through Week 8)|lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
1211235|NCT00262522|P1|Participant Flow|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
1211236|NCT00262522|O4|Outcome|LPV/r 400/100 mg BID SGC (Through Week 8)|lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
1211237|NCT00262522|O3|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
1211238|NCT00262522|O2|Outcome|LPV/r 800/200 mg QD SGC (Through Week 8)|lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
1211239|NCT00262522|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
1211240|NCT00262522|O4|Outcome|LPV/r 400/100 mg BID SGC (Through Week 8)|lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
1211241|NCT00262522|O3|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
1211242|NCT00262522|O2|Outcome|LPV/r 800/200 mg QD SGC (Through Week 8)|lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
1211243|NCT00262522|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
1211244|NCT00262522|O4|Outcome|LPV/r 400/100 mg BID SGC (Through Week 8)|lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
1211245|NCT00262522|O3|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
1211246|NCT00262522|O2|Outcome|LPV/r 800/200 mg QD SGC (Through Week 8)|lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
1211247|NCT00262522|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
1211254|NCT00262509|B3|Baseline|Total|Total of all reporting groups
1211255|NCT00262509|B2|Baseline|First Intervention, Then Baseline|"Intervention First: Blind Participants are trained for 15 minutes in the use of the egress badge, then in two separate timed trials are walked into a building to different randomized locations, and are asked to find their way out of the building. Each Trial takes at most 15 minutes.~Baseline Next: For two separate timed trials Blind Participants are walked into a building to different randomized locations, and then asked to find their way out of the building. Each Trial takes at most 15 minutes."
1211256|NCT00262509|B1|Baseline|First Baseline, Then Intervention|"Baseline First: For two separate timed trials Blind Participants are walked into a building to different randomized locations, and then asked to find their way out of the building. Each Trial takes at most 15 minutes.~Intervention Next: Blind Participants are trained for 15 minutes in the use of the egress badge, then in two separate timed trials are walked into a building to different randomized locations, and are asked to find their way out of the building. Each Trial takes at most 15 minutes."
1211257|NCT00262509|P2|Participant Flow|Intervention First, Then Baseline|"Intervention First: Blind Participants are trained for 15 minutes in the use of the egress badge, then in two separate timed trials are walked into a building to different randomized locations, and are asked to find their way out of the building. Each Trial lasted at most 15 minutes.~Baseline Next: For two separate timed trials Blind Participants are walked into a building to different randomized locations, and then asked to find their way out of the building. Each Trial lasted at most 15 minutes."
1211296|NCT00262223|B1|Baseline|1) Seeking Safety + Sertraline|Seeking Safety, a cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders + Setraline, an anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type
1211335|NCT00262080|O2|Outcome|Placebo|Patients treated with placebo in the double-blind part.
1214615|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
1211258|NCT00262509|P1|Participant Flow|Baseline First, Then Intervention|"Baseline First: For two separate timed trials Blind Participants are walked into a building to different randomized locations, and then asked to find their way out of the building. Each Trial lasted at most 15 minutes.~Intervention Next: Blind Participants are trained for 15 minutes in the use of the egress badge, then in two separate timed trials are walked into a building to different randomized locations, and are asked to find their way out of the building. Each Trial lasted at most 15 minutes."
1211259|NCT00262509|O2|Outcome|Baseline|All Blind Participants, in two separate trials, are walked into a building to a specific location, and then are asked to find their way out of the building. Their egress performance is timed for each trial. The outcome measure is calculated as the average of the trial times.
1211260|NCT00262509|O1|Outcome|Intervention|All Blind Participants are trained for 15 minutes in the use of the egress device, then for two separate trials are walked into a building to a specific location, and are asked to find their way out of the building. Their egress performance is timed for each trial. The outcome measure is obtained by averaging the two trial times
1211261|NCT00262509|E2|Reported Event|Baseline Egress|Blind subjects are walked into a building to different locations in two separate trials and then asked to find their way out of the building.
1211262|NCT00262509|E1|Reported Event|Egress Badge Intervention|Blind Participants are trained for 15 minutes in the use of the egress badge, then for two separate trials they are walked into a building to a different locations, and are asked to find their way out of the building.
1211263|NCT00262314|B1|Baseline|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
1211264|NCT00262314|P1|Participant Flow|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
1211265|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
1211266|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
1211267|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
1211268|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
1211269|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
1211270|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
1211271|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
1211272|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
1211273|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
1211274|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
1211275|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
1211276|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
1211277|NCT00262314|E1|Reported Event|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
1211278|NCT00262301|B4|Baseline|Total|Total of all reporting groups
1211279|NCT00262301|B3|Baseline|"1 Vial (2100 IU) rhC1INH"|"Includes all subjects who received 1 vial (2100 IU) open-label rhC1INH in the open-label extension phase."
1211280|NCT00262301|B2|Baseline|Saline|Includes all subjects randomized and who received Saline solution in the double-blind phase.
1211281|NCT00262301|B1|Baseline|"100 IU/kg rhC1INH"|Includes all subjects randomized who received 100 IU/kg recombinant human C1 inhibitor in the double-blind phase.
1211282|NCT00262301|P3|Participant Flow|"1 Vial (2100 IU) rhC1INH"|"Includes all subjects who received, 1 vial (2100 IU) open-label rhC1INH in the open-label extension phase. Patients received 1 vial initially and could receive an additional 1-2 vials within 4 hours at the investigator's discretion."
1211283|NCT00262301|P2|Participant Flow|Saline|Includes all subjects randomized and who received Saline solution in the double-blind phase.
1211284|NCT00262301|P1|Participant Flow|"100 IU/kg rhC1INH"|Includes all subjects randomized and who received 100 IU/kg recombinant human C1 inhibitor in the double-blind phase.
1211285|NCT00262301|O3|Outcome|"1 Vial (2100 IU) rhC1INH"|"Includes all subjects who received 1 vial (2100 IU) open-label rhC1INH in the open-label extension phase."
1211286|NCT00262301|O2|Outcome|Saline|Includes all subjects randomized and who received Saline solution in the double-blind phase.
1211287|NCT00262301|O1|Outcome|"100 IU/kg rhC1INH"|Includes all subjects randomized who received 100 IU/kg recombinant human C1 inhibitor in the double-blind phase.
1211288|NCT00262301|O3|Outcome|"1 Vial (2100 IU) rhC1INH"|"Includes all subjects who received 1 vial (2100 IU) open-label rhC1INH in the open-label extension phase."
1211289|NCT00262301|O2|Outcome|Saline|Includes all subjects randomized and who received Saline solution in the double-blind phase.
1211290|NCT00262301|O1|Outcome|"100 IU/kg rhC1INH"|Includes all subjects randomized who received 100 IU/kg recombinant human C1 inhibitor in the double-blind phase.
1211291|NCT00262301|E3|Reported Event|"1 Vial (2100 IU) rhC1INH"|"Includes all subjects who received 1 vial (2100 IU) open-label rhC1INH in the open-label extension phase."
1211292|NCT00262301|E2|Reported Event|Saline|Includes all subjects randomized and who received Saline solution in the double-blind phase.
1211293|NCT00262301|E1|Reported Event|"100 IU/kg rhC1INH"|Includes all subjects randomized who received 100 IU/kg recombinant human C1 inhibitor in the double-blind phase.
1211294|NCT00262223|B3|Baseline|Total|Total of all reporting groups
1211295|NCT00262223|B2|Baseline|2) Seeking Safety + Placebo|Seeking Safety, a cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders + Pill placebo
1211334|NCT00262080|O1|Outcome|Ecallantide|Patients treated with ecallantide in the repeat-dose part.
1211411|NCT00262028|B10|Baseline|Total|Total of all reporting groups
1211297|NCT00262223|P2|Participant Flow|2) Seeking Safety + Placebo|"Seeking Safety + Placebo;~Seeking Safety: Seeking Safety cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders~Sertraline: An anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type"
1211298|NCT00262223|P1|Participant Flow|1) Seeking Safety + Sertraline|"Seeking Safety + Sertraline~Seeking Safety: Seeking Safety cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders~Sertraline: An anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type"
1211299|NCT00262223|O2|Outcome|2) Seeking Safety + Placebo|Seeking Safety + Placebo;
1211300|NCT00262223|O1|Outcome|1) Seeking Safety + Sertraline|Seeking Safety + Sertraline
1211301|NCT00262223|O2|Outcome|2) Seeking Safety + Placebo|Seeking Safety + Placebo
1211302|NCT00262223|O1|Outcome|1) Seeking Safety + Sertraline|Seeking Safety + Sertraline
1211303|NCT00262223|E2|Reported Event|Seeking Seeking + Placebo|Seeking Safety, a cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders + Pill Placebo
1211304|NCT00262223|E1|Reported Event|Seeking Safety + Sertraline|Seeking Safety, a cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders, + Setraline, an anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type
1211305|NCT00262119|B4|Baseline|Total|Total of all reporting groups
1211306|NCT00262119|B3|Baseline|DDDRP|"PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
1211307|NCT00262119|B2|Baseline|MVP Only|"PM programming according to actual clinical practice + MVP algorithm ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
1211308|NCT00262119|B1|Baseline|Control Group|"PM programming according to actual clinical practice~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
1211309|NCT00262119|P3|Participant Flow|DDDRP|"PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
1211310|NCT00262119|P2|Participant Flow|MVP Only|"PM programming according to actual clinical practice + MVP algorithm ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
1211311|NCT00262119|P1|Participant Flow|Control Group|"PM programming according to actual clinical practice~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
1211312|NCT00262119|O3|Outcome|DDDRP|"PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
1211313|NCT00262119|O2|Outcome|MVP Only|"PM programming according to actual clinical practice + MVP algorithm ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
1211314|NCT00262119|O1|Outcome|Control Group|"PM programming according to actual clinical practice~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
1211315|NCT00262119|O3|Outcome|DDDRP|"PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
1211316|NCT00262119|O2|Outcome|MVP Only|"PM programming according to actual clinical practice + MVP algorithm ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
1211317|NCT00262119|O1|Outcome|Control Group|"PM programming according to actual clinical practice~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
1211318|NCT00262119|O3|Outcome|DDDRP|"PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
1211319|NCT00262119|O2|Outcome|MVP Only|"PM programming according to actual clinical practice + MVP algorithm ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
1211320|NCT00262119|O1|Outcome|Control Group|"PM programming according to actual clinical practice~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
1211321|NCT00262119|O3|Outcome|DDDRP|"PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
1211322|NCT00262119|O2|Outcome|MVP Only|"PM programming according to actual clinical practice + MVP algorithm ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
1211323|NCT00262119|O1|Outcome|Control Group|"PM programming according to actual clinical practice~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
1211324|NCT00262119|E3|Reported Event|DDDRP|"PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
1211325|NCT00262119|E2|Reported Event|MVP Only|"PM programming according to actual clinical practice + MVP algorithm ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
1211326|NCT00262119|E1|Reported Event|Control Group|"PM programming according to actual clinical practice~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
1211328|NCT00262080|B3|Baseline|Ecallantide (Repeat-Dosing Part Only)|"Patients not treated in the double-blind part but treated with ecallantide in the repeat-dosing part.~One patient was omitted from analysis in the intent-to-treat and per-protocol populations due to the loss of the data for the 4-hour post-dose assessments during treatment episode 1."
1211329|NCT00262080|B2|Baseline|Placebo / Ecallantide|Patients treated with placebo in the double-blind part (ITT as treated) and eligible for treatment with ecallantide in the repeat-dosing part of the study once their Follow-up Visit 1 (Day 7) in the double-blind part was completed.
1211330|NCT00262080|B1|Baseline|Ecallantide / Ecallantide|Patients treated with ecallantide in the double-blind part (ITT as treated) and eligible for treatment with ecallantide in the repeat-dosing part of the study once their Follow-up Visit 1 (Day 7) in the double-blind part was completed.
1211331|NCT00262080|P3|Participant Flow|Ecallantide (Repeat Dose Only)|Patients not treated in the double-blind part but treated with ecallantide in the repeat-dosing part.
1211332|NCT00262080|P2|Participant Flow|Placebo / Ecallantide|Patients treated with placebo in the double-blind part and eligible for treatment with ecallantide in the repeat-dosing part of the study once their Follow-up Visit 1 (Day 7) in the double-blind part was completed.
1211333|NCT00262080|P1|Participant Flow|Ecallantide / Ecallantide|Patients treated with ecallantide in the double-blind part and eligible for treatment with ecallantide in the repeat-dosing part of the study once their Follow-up Visit 1 (Day 7) in the double-blind part was completed.
1214616|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
1211336|NCT00262080|O1|Outcome|Ecallantide|Patients treated with ecallantide in the double-blind part.
1211337|NCT00262080|O1|Outcome|Ecallantide|Patients treated with ecallantide in the repeat-dose part.
1211338|NCT00262080|O1|Outcome|Ecallantide|Patients treated with ecallantide in the repeat-dose part.
1211339|NCT00262080|O2|Outcome|Placebo|Patients treated with placebo in the double-blind part.
1211340|NCT00262080|O1|Outcome|Ecallantide|Patients treated with ecallantide in the double-blind part.
1211341|NCT00262080|O2|Outcome|Placebo|Patients treated with placebo in the double-blind part.
1211342|NCT00262080|O1|Outcome|Ecallantide|Patients treated with ecallantide in the double-blind part.
1211343|NCT00262080|O2|Outcome|Placebo|Patients treated with placebo in the double-blind part.
1211344|NCT00262080|O1|Outcome|Ecallantide|Patients treated with ecallantide in the double-blind part.
1211345|NCT00262080|E3|Reported Event|Repeat-Dosing Ecallantide|All patients treated with ecallantide in the repeat-dosing part, regardless of whether they were treated previously in the double-blind part or not. All adverse events reported in all repeat-dosing episodes are included. Patients reporting more than 1 AE with the same preferred term are counted only once for that preferred term.
1211346|NCT00262080|E2|Reported Event|Double-Blind Placebo|Patients treated with placebo in the double-blind part only.
1211347|NCT00262080|E1|Reported Event|Double Blind - Ecallantide|Patients treated with ecallantide in the double-blind part only.
1211348|NCT00262067|B5|Baseline|Total|Total of all reporting groups
1211349|NCT00262067|B4|Baseline|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
1211350|NCT00262067|B3|Baseline|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
1211351|NCT00262067|B2|Baseline|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
1211352|NCT00262067|B1|Baseline|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
1211353|NCT00262067|P4|Participant Flow|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
1211354|NCT00262067|P3|Participant Flow|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
1211355|NCT00262067|P2|Participant Flow|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
1211356|NCT00262067|P1|Participant Flow|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
1211357|NCT00262067|O4|Outcome|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
1211358|NCT00262067|O3|Outcome|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
1211359|NCT00262067|O2|Outcome|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
1211360|NCT00262067|O1|Outcome|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
1211361|NCT00262067|O4|Outcome|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
1211362|NCT00262067|O3|Outcome|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
1212947|NCT00257686|O4|Outcome|Pravastatin 20 mg|Pravastatin 20 mg once daily
1211363|NCT00262067|O2|Outcome|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
1211364|NCT00262067|O1|Outcome|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
1211365|NCT00262067|O4|Outcome|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
1211366|NCT00262067|O3|Outcome|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
1211367|NCT00262067|O2|Outcome|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
1211368|NCT00262067|O1|Outcome|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
1211369|NCT00262067|O4|Outcome|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
1212600|NCT00259090|E3|Reported Event|Anastrozole|Anastrozole 1 mg once daily tablet
1211370|NCT00262067|O3|Outcome|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
1211371|NCT00262067|O2|Outcome|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
1211372|NCT00262067|O1|Outcome|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
1211373|NCT00262067|O4|Outcome|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
1211374|NCT00262067|O3|Outcome|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
1211375|NCT00262067|O2|Outcome|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
1211376|NCT00262067|O1|Outcome|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
1211377|NCT00262067|O4|Outcome|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
1211378|NCT00262067|O3|Outcome|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
1211379|NCT00262067|O2|Outcome|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
1211380|NCT00262067|O1|Outcome|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
1211381|NCT00262067|E4|Reported Event|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
1211382|NCT00262067|E3|Reported Event|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
1211383|NCT00262067|E2|Reported Event|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
1211384|NCT00262067|E1|Reported Event|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
1211385|NCT00262041|B5|Baseline|Total|Total of all reporting groups
1211386|NCT00262041|B4|Baseline|MenACWY-PS -Stage 2|Subjects received a single dose of MenACWY polysaccharide vaccine (Stage 2 - 4:1 MenACWY-CRM:MenACWY-PS randomization scheme).
1211387|NCT00262041|B3|Baseline|MenACWY-PS - Stage 1|Subjects received a single of MenACWY polysaccharide vaccine on day 1 (Stage 1 - 1:1 randomization scheme).
1211388|NCT00262041|B2|Baseline|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
1211389|NCT00262041|B1|Baseline|MenACWY-CRM(Ad+)|Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
1211390|NCT00262041|P3|Participant Flow|MenACWY-PS|Subjects received one single dose of the MenACWY polysaccharide vaccine.
1211391|NCT00262041|P2|Participant Flow|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
1211392|NCT00262041|P1|Participant Flow|MenACWY-CRM(Ad+)|Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
1211393|NCT00262041|O4|Outcome|MenACWY-PS -Stage 2|Subjects received a single dose of MenACWY polysaccharide vaccine (Stage 2)
1211394|NCT00262041|O3|Outcome|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
1211395|NCT00262041|O2|Outcome|MenACWY-PS - Stage 1|Subjects received a single of MenACWY polysaccharide vaccine on day 1 (Stage 1)
1212948|NCT00257686|O3|Outcome|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
1211399|NCT00262041|O2|Outcome|MenACWY-PS|Subjects received one single dose of the MenACWY polysaccharide vaccine.
1211400|NCT00262041|O1|Outcome|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
1211401|NCT00262041|O3|Outcome|MenACWY-PS|Subjects received one single dose of the MenACWY polysaccharide vaccine.
1211402|NCT00262041|O2|Outcome|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
1211403|NCT00262041|O1|Outcome|MenACWY-CRM(Ad+)|Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
1211404|NCT00262041|O3|Outcome|MenACWY-PS|Subjects received one single dose of the MenACWY polysaccharide vaccine.
1211405|NCT00262041|O2|Outcome|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
1211406|NCT00262041|O1|Outcome|MenACWY-CRM(Ad+)|Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
1211407|NCT00262041|E4|Reported Event|MenACWY-PS -Stage 2|Subjects received a single dose of MenACWY polysaccharide vaccine (Stage 2 - 4:1 MenACWY-CRM:MenACWY-PS randomization scheme).
1211408|NCT00262041|E3|Reported Event|MenACWY-PS - Stage 1|Subjects received a single of MenACWY polysaccharide vaccine on day 1 (Stage 1 - 1:1 randomization scheme).
1211409|NCT00262041|E2|Reported Event|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
1211410|NCT00262041|E1|Reported Event|MenACWY-CRM(Ad+)|Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
1211412|NCT00262028|B9|Baseline|MenACWY+PS (3-5 YearsOld)|Children aged 3 to 5 years receiving MenACWY-PS from the first part of the study (Menomune, not licensed in US in children under 2 years of age) were used as controls for the 12-23-months-old part two toddlers.
1211413|NCT00262028|B8|Baseline|MenACWY+DTaP (16-23 Months Old)|Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with DTaP vaccine.
1211414|NCT00262028|B7|Baseline|MenACWY (16-23 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
1211415|NCT00262028|B6|Baseline|MenACWY-PnC (12-15 Months Old)|Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with pneumococcal conjugate vaccine.
1211416|NCT00262028|B5|Baseline|MenACWY (12-15 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
1211417|NCT00262028|B4|Baseline|MenACWY-PS (6-10 Years Old)|Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
1211418|NCT00262028|B3|Baseline|MenACWY (6-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
1211419|NCT00262028|B2|Baseline|MenACWY-PS (2-5 Years Old)|Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
1211420|NCT00262028|B1|Baseline|MenACWY (2-5 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
1211421|NCT00262028|P9|Participant Flow|MenACWY-PS (3-5 Years Old)|Children aged 3 to 5 years receiving MenACWY- polysaccharide (PS) vaccine from the first part of the study (Menomune, not licensed in US in children under 2 years of age) were used as controls for the 12-23-months-old part two toddlers.
1211422|NCT00262028|P8|Participant Flow|MenACWY+DTaP (16-23 Months)|Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with diphtheria-tetanus-acellular pertussis (DTaP) vaccine.
1211423|NCT00262028|P7|Participant Flow|MenACWY (16-23 Months)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
1211424|NCT00262028|P6|Participant Flow|MenACWY+PnC (12-15 Months)|Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with pneumococcal conjugate vaccine (PnC).
1211425|NCT00262028|P5|Participant Flow|MenACWY (12-15 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
1211426|NCT00262028|P4|Participant Flow|MenACWY-PS (6-10 Years Old)|Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
1211427|NCT00262028|P3|Participant Flow|MenACWY (6-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
1211428|NCT00262028|P2|Participant Flow|MenACWY-PS (2-5 Years Old)|Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
1211429|NCT00262028|P1|Participant Flow|MenACWY (2-5 Years Old)|Subjects received one dose of the investigational MenACWY-cross-reactive material (CRM) conjugate vaccine.
1211430|NCT00262028|O4|Outcome|MenACWY-CRM + DTaP (16-23 Months)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine in concomitant with DTaP
1211431|NCT00262028|O3|Outcome|MenACWY-CRM (16-23 Months)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
1211432|NCT00262028|O2|Outcome|MenACWY-CRM + PnC (12-15 Months Old)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine in concomitant with PnC
1211433|NCT00262028|O1|Outcome|MenACWY-CRM (12-15 Months Old)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
1211434|NCT00262028|O4|Outcome|MenACWY-PS (6-10 Years Old)|Subjects received one dose of licensed MenACWY-PS vaccine
1211435|NCT00262028|O3|Outcome|MenACWY-CRM (6-10 Years Old)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
1211436|NCT00262028|O2|Outcome|MenACWY-PS (2-5 Years Old)|Subjects received one dose of licensed MenACWY-PS vaccine
1211437|NCT00262028|O1|Outcome|MenACWY-CRM (2-5 Years Old)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
1211438|NCT00262028|O4|Outcome|MenACWY-CRM + DTaP (16-23 Months)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine concomitantly with DTaP
1211439|NCT00262028|O3|Outcome|MenACWY-CRM (16-23 Months)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
1211440|NCT00262028|O2|Outcome|MenACWY-CRM + PnC (12-15 Months)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine concomitantly with PnC
1211441|NCT00262028|O1|Outcome|MenACWY-CRM (12-15 Months)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
1211442|NCT00262028|O4|Outcome|MenACWY-PS (6-10 Years Old)|Subjects received one dose of licensed MenACWY-PS vaccine
1211443|NCT00262028|O3|Outcome|MenACWY-CRM (6-10 Years Old)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
1211444|NCT00262028|O2|Outcome|MenACWY-PS (2-5 Years Old)|Subjects received one dose of licensed MenACWY-PS vaccine
1211445|NCT00262028|O1|Outcome|MenACWY-CRM (2-5 Years Old)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
1211446|NCT00262028|O6|Outcome|MenACWY-PS (6-10 Years Old)|Subjects received one dose of the licensed MenACWY-PS vaccine
1211447|NCT00262028|O5|Outcome|MenACWY-CRM (6-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
1211448|NCT00262028|O4|Outcome|MenACWY-PS (2-5 Years Old)|Subjects received one dose of the licensed MenACWY-PS vaccine
1211449|NCT00262028|O3|Outcome|MenACWY-CRM (2-5 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
1211450|NCT00262028|O2|Outcome|MenACWY-PS (2-10 Years Old)|Subjects received one dose of the licensed MenACWY-PS vaccine
1211451|NCT00262028|O1|Outcome|MenACWY-CRM (2-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
1211452|NCT00262028|O6|Outcome|MenACWY-PS (6-10 Years)|Subjects received one dose of the licensed MenACWY-PS vaccine
1211453|NCT00262028|O5|Outcome|MenACWY-CRM (6-10 Years)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
1211454|NCT00262028|O4|Outcome|MenACWY-PS (2-5 Years)|Subjects received one dose of the licensed MenACWY-PS vaccine
1211455|NCT00262028|O3|Outcome|MenACWY-CRM (2-5 Years)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
1211456|NCT00262028|O2|Outcome|MenACWY-PS (2-10 Years)|Subjects received one dose of the licensed MenACWY-PS vaccine
1211457|NCT00262028|O1|Outcome|MenACWY-CRM (2-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
1211458|NCT00262028|O2|Outcome|MenACWY-PS (3-5 Years Old)|Subjects received one dose of the licensed MenACWY-PS vaccine This group was a subset of the Licensed comparator (2-5 year old) cohort that received one dose of licensed MenACWY-PS vaccine.
1211459|NCT00262028|O1|Outcome|MenACWY-CRM (12-23 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
1211460|NCT00262028|O4|Outcome|MenACWY-PS (6-10 Years Old)|Subjects received one dose of MenACWY-PS vaccine
1211461|NCT00262028|O3|Outcome|MenACWY-CRM (6-10 Years Old)|Subjects received one dose of MenACWY-CRM conjugate vaccine
1211462|NCT00262028|O2|Outcome|MenACWY-PS (2-5 Years Old)|Subjects received one dose of the MenACWY-PS vaccine
1211463|NCT00262028|O1|Outcome|MenACWY-CRM (2-5 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
1211464|NCT00262028|O2|Outcome|MenACWY-PS (2-10 Years)|Subjects received one dose of the licensed MenACWY-PS vaccine
1211465|NCT00262028|O1|Outcome|MenACWY-CRM (2-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
1211466|NCT00262028|O2|Outcome|MenACWY-PS (3-5 Years Old)|Subjects received one dose of the licensed MenACWY-PS vaccine. This group was a subset of the licensed comparator (2-5 years old) cohort that received one dose of licensed MenACWY-PS vaccine
1211467|NCT00262028|O1|Outcome|MenACWY-CRM (12-23 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
1211468|NCT00262028|O4|Outcome|MenACWY-PS (6-10 Years Old)|Subjects received one dose of licensed MenACWY-PS vaccine
1211469|NCT00262028|O3|Outcome|MenACWY-CRM (6-10 Years Old)|Subjects received one dose of investigational MenACWY-CRM vaccine
1211470|NCT00262028|O2|Outcome|MenACWY-PS (2-5 Years Old)|Subjects received one dose of the licensed MenACWY-PS vaccine
1211471|NCT00262028|O1|Outcome|MenACWY-CRM (2-5 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
1211472|NCT00262028|O2|Outcome|MenACWY-PS (2-10 Years)|Subjects received one dose of the licensed MenACWY-PS vaccine
1211473|NCT00262028|O1|Outcome|MenACWY-CRM (2-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
1211474|NCT00262028|E9|Reported Event|MenACWY-PS (3-5 Years Old)|Children aged 3 to 5 years receiving MenACWY-PS from the first part of the study (Menomune not licensed in US in children under 2 years of ages) served as controls for the 12-23-months-old part two toddlers.
1211475|NCT00262028|E8|Reported Event|MenACWY+DTaP (16-23 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine administered concomitantly with DTaP vaccine.
1211476|NCT00262028|E7|Reported Event|MenACWY (16-23 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
1211477|NCT00262028|E6|Reported Event|MenACWY-PnC (12-15 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine administered concomitantly with pneumococcal conjugate vaccine.
1211478|NCT00262028|E5|Reported Event|MenACWY (12-15 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
1211479|NCT00262028|E4|Reported Event|MenACWY-PS (6-10 Years Old)|Subjects received one dose of the licensed MenACWY-CRM polysaccharide vaccine.
1211480|NCT00262028|E3|Reported Event|MenACWY (6-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
1211481|NCT00262028|E2|Reported Event|MenACWY-PS (2-5 Years Old)|Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
1211482|NCT00262028|E1|Reported Event|MenACWY (2-5 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
1211483|NCT00262002|B8|Baseline|Total|Total of all reporting groups
1211484|NCT00262002|B7|Baseline|CA24- (MenACWY Ad- at 2,4m)|Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
1211485|NCT00262002|B6|Baseline|UK24- (MenACWY Ad- at 2,4m)|Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
1211486|NCT00262002|B5|Baseline|CA24+ (MenACWY Ad+ at 2,4m)|Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
1211509|NCT00262002|O6|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
1212949|NCT00257686|O2|Outcome|Pravastatin 10 mg|Pravastatin 10 mg once daily
1211487|NCT00262002|B4|Baseline|CA246+ (MenACWY Ad+ at 2,4,6m)|Three doses of MenACWY Ad+ vaccine were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
1211488|NCT00262002|B3|Baseline|UKMenC (Menjugate at 2,4m)|Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
1211489|NCT00262002|B2|Baseline|UK24+ (MenACWY Ad+ at 2,4 m)|Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
1211490|NCT00262002|B1|Baseline|UK234+ (MenACWY Ad+ at 2,3,4 m)|Three doses of MenACWY Ad+ vaccine were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
1211491|NCT00262002|P7|Participant Flow|CA24- (MenACWY Ad- at 2,4m)|"Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
1211492|NCT00262002|P6|Participant Flow|UK24- (MenACWY Ad- at 2,4m)|Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
1211493|NCT00262002|P5|Participant Flow|CA24+ (MenACWY Ad+ at 2,4m)|"Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
1211494|NCT00262002|P4|Participant Flow|CA246+ (MenACWY Ad+ at 2,4,6m)|Three doses of MenACWY Ad+ vaccine were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
1211495|NCT00262002|P3|Participant Flow|UKMenC (Menjugate at 2,4m)|Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
1211496|NCT00262002|P2|Participant Flow|UK24+ (MenACWY Ad+ at 2,4 m)|Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
1211497|NCT00262002|P1|Participant Flow|UK234+ (MenACWY Ad+ at 2,3,4 m)|Three doses of MenACWY Ad+ vaccine were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
1211498|NCT00262002|O10|Outcome|CA24- (MenACWY Ad- at 2, 4 m) - PS|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
1211499|NCT00262002|O9|Outcome|CA24- (MenACWY Ad- at 2, 4 m) - ACWY|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
1211500|NCT00262002|O8|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
1211501|NCT00262002|O7|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m) - PS|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
1211502|NCT00262002|O6|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m) - ACWY|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
1211503|NCT00262002|O5|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m) - PS|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
1211504|NCT00262002|O4|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m) - No Treatment|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
1211505|NCT00262002|O3|Outcome|UKMenC (Menjugate at 2, 4 m)|Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
1211506|NCT00262002|O2|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
1211507|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2,3,4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
1211508|NCT00262002|O7|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|"Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
1211510|NCT00262002|O5|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
1211511|NCT00262002|O4|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
1211512|NCT00262002|O3|Outcome|UKMenC (Menjugate at 2, 4 m)|Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
1211513|NCT00262002|O2|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
1211514|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
1212235|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1211515|NCT00262002|O5|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
1211516|NCT00262002|O4|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
1211517|NCT00262002|O3|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
1211518|NCT00262002|O2|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
1211519|NCT00262002|O1|Outcome|UKMenC (Menjugate at 2, 4 m)|Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
1211520|NCT00262002|O6|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
1211521|NCT00262002|O5|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
1211522|NCT00262002|O4|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
1211523|NCT00262002|O3|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
1211524|NCT00262002|O2|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
1211525|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
1211526|NCT00262002|O6|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
1211527|NCT00262002|O5|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
1211528|NCT00262002|O4|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
1211529|NCT00262002|O3|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
1211530|NCT00262002|O2|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
1211593|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
1211531|NCT00262002|O1|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
1211532|NCT00262002|O2|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
1211533|NCT00262002|O1|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
1211534|NCT00262002|O4|Outcome|CA24+ (MenACWY Ad+ at 2, 4m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
1212724|NCT00258674|B4|Baseline|Total|Total of all reporting groups
1211535|NCT00262002|O3|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
1211536|NCT00262002|O2|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was to be given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
1211537|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
1211538|NCT00262002|O2|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
1211539|NCT00262002|O1|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
1211540|NCT00262002|O2|Outcome|CA24- (MenACWY Ad- at 2, 4m)|"Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
1211541|NCT00262002|O1|Outcome|CA24+ (MenACWY Ad+ at 2, 4m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
1211542|NCT00262002|O1|Outcome|CA246+ (MenACWY Ad+ at 2, 4,6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
1211543|NCT00262002|O1|Outcome|CA246+ (MenACWY Ad+ at 2,4,6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
1211544|NCT00262002|O2|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
1211545|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
1211546|NCT00262002|O2|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
1211547|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age
1211548|NCT00262002|O5|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|"Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
1212267|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1211549|NCT00262002|O4|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
1211550|NCT00262002|O3|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
1211551|NCT00262002|O2|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
1211552|NCT00262002|O1|Outcome|UKMenC (Menjugate at 2, 4 m)|Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
1211553|NCT00262002|O5|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|"Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
1214617|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
1211554|NCT00262002|O4|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose ( of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
1211555|NCT00262002|O3|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
1211556|NCT00262002|O2|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
1211557|NCT00262002|O1|Outcome|UKMenC (Menjugate 2, 4 m)|Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
1211558|NCT00262002|O5|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|"Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
1211559|NCT00262002|O4|Outcome|CA24+ (MenACWY Ad+ at 2, 4m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
1211560|NCT00262002|O3|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
1211561|NCT00262002|O2|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
1211562|NCT00262002|O1|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
1211563|NCT00262002|O5|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
1211564|NCT00262002|O4|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
1211565|NCT00262002|O3|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
1211566|NCT00262002|O2|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
1211567|NCT00262002|O1|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
1211568|NCT00262002|O4|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
1211569|NCT00262002|O3|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
1211570|NCT00262002|O2|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
1211571|NCT00262002|O1|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
1211906|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211572|NCT00262002|O4|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
1211573|NCT00262002|O3|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
1211574|NCT00262002|O2|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
1211575|NCT00262002|O1|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
1211908|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211576|NCT00262002|O2|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
1211577|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
1211578|NCT00262002|O2|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
1211579|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
1211580|NCT00262002|O2|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
1211581|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant vaccine were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
1211582|NCT00262002|E7|Reported Event|CA24- (MenACWY Ad- at 2,4m)|Two doses of MenACWY Ad- vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar® at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was to be given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
1211583|NCT00262002|E6|Reported Event|UK24- (MenACWY Ad- at 2,4m)|Two doses of MenACWY Ad- vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was to be given at 12 months of age.
1211584|NCT00262002|E5|Reported Event|CA24+ (MenACWY Ad+ at 2,4m)|Two doses of MenACWY Ad+ vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was to be given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
1211585|NCT00262002|E4|Reported Event|CA246+ (MenACWY Ad+ at 2,4,6m)|Three doses of MenACWY Ad+ vaccine were to be given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar® at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was to be given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was to be administered one dose of MMR (and Prevnar, if available) at 12 months of age.
1211586|NCT00262002|E3|Reported Event|UKMenC (Menjugate at 2,4m)|Two doses of Menjugate® were to be given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was to be given at 12 months of age.
1211587|NCT00262002|E2|Reported Event|UK24+ (MenACWY Ad+ at 2,4 m)|Two doses of MenACWY Ad+ vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was to be given at 12 months of age.
1211588|NCT00262002|E1|Reported Event|UK234+ (MenACWY Ad+ at 2,3,4 m)|Three doses of MenACWY Ad+ vaccine were to be given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was to be given at 12 months of age.
1211589|NCT00261950|B1|Baseline|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
1211590|NCT00261950|P1|Participant Flow|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
1211591|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
1211592|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
1212428|NCT00260065|O1|Outcome|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.
1211594|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
1211595|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
1211596|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
1211597|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
1213036|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
1211598|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
1211599|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
1211600|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
1211601|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
1211602|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
1211603|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
1211604|NCT00261950|E1|Reported Event|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
1211605|NCT00261846|B12|Baseline|Total|Total of all reporting groups
1211606|NCT00261846|B11|Baseline|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211607|NCT00261846|B10|Baseline|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211608|NCT00261846|B9|Baseline|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211609|NCT00261846|B8|Baseline|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211610|NCT00261846|B7|Baseline|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211611|NCT00261846|B6|Baseline|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211612|NCT00261846|B5|Baseline|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211613|NCT00261846|B4|Baseline|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211614|NCT00261846|B3|Baseline|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211615|NCT00261846|B2|Baseline|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211635|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) resistant (R) chronic myelogenous leukemia (CML).
1211616|NCT00261846|B1|Baseline|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211617|NCT00261846|P14|Participant Flow|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211618|NCT00261846|P13|Participant Flow|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211619|NCT00261846|P12|Participant Flow|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211620|NCT00261846|P11|Participant Flow|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211621|NCT00261846|P10|Participant Flow|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211622|NCT00261846|P9|Participant Flow|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211623|NCT00261846|P8|Participant Flow|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211624|NCT00261846|P7|Participant Flow|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211625|NCT00261846|P6|Participant Flow|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211626|NCT00261846|P5|Participant Flow|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211627|NCT00261846|P4|Participant Flow|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211628|NCT00261846|P3|Participant Flow|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. Eleven participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
1211629|NCT00261846|P2|Participant Flow|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211630|NCT00261846|P1|Participant Flow|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211631|NCT00261846|O9|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL)
1211632|NCT00261846|O8|Outcome|BP-CML Total|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) chronic myelogenous leukemia (CML) who were imatinib (IM) resistant/intolerant (R/I) or Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I).
1211633|NCT00261846|O7|Outcome|AP-CML Total|All participants who received bosutinib 500 mg orally once daily in advanced phase (AP) chronic myelogenous leukemia (CML) who were imatinib (IM) resistant/intolerant (R/I) or Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I).
1211634|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML).
1211938|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211636|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML).
1211637|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML).
1211638|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
1212036|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211639|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM.
1211640|NCT00261846|O11|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211641|NCT00261846|O10|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211642|NCT00261846|O9|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211643|NCT00261846|O8|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211644|NCT00261846|O7|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211645|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211646|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211647|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211648|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211649|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211650|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211651|NCT00261846|O9|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211652|NCT00261846|O8|Outcome|BP-CML Total|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) chronic myelogenous leukemia (CML) who were imatinib (IM) resistant/intolerant (R/I) or Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211653|NCT00261846|O7|Outcome|AP-CML Total|All participants who received bosutinib 500 mg orally once daily in advanced phase (AP) chronic myelogenous leukemia (CML) who were imatinib (IM) resistant/intolerant (R/I) or Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211654|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211730|NCT00261846|O9|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211655|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211656|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1212361|NCT00260689|E1|Reported Event|Horse ATG/CsA Taper|Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
1211657|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211658|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211659|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211660|NCT00261846|O9|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211661|NCT00261846|O8|Outcome|BP-CML Total|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) chronic myelogenous leukemia (CML) who were imatinib (IM) resistant/intolerant (R/I) or Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211662|NCT00261846|O7|Outcome|AP-CML Total|All participants who received bosutinib 500 mg orally once daily in advanced phase (AP) chronic myelogenous leukemia (CML) who were imatinib (IM) resistant/intolerant (R/I) or Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211663|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211664|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211665|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211666|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211667|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211668|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211669|NCT00261846|O9|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211670|NCT00261846|O8|Outcome|BP-CML Total|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) chronic myelogenous leukemia (CML) who were imatinib (IM) resistant/intolerant (R/I) or Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211671|NCT00261846|O7|Outcome|AP-CML Total|All participants who received bosutinib 500 mg orally once daily in advanced phase (AP) chronic myelogenous leukemia (CML) who were imatinib (IM) resistant/intolerant (R/I) or Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211672|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211903|NCT00261495|P1|Participant Flow|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211673|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211674|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211675|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211676|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211677|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211678|NCT00261846|O9|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211679|NCT00261846|O8|Outcome|BP-CML Total|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) chronic myelogenous leukemia (CML) who were imatinib (IM) resistant/intolerant (R/I) or Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211680|NCT00261846|O7|Outcome|AP-CML Total|All participants who received bosutinib 500 mg orally once daily in advanced phase (AP) chronic myelogenous leukemia (CML) who were imatinib (IM) resistant/intolerant (R/I) or Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211681|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211682|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211683|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211684|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211685|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211686|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211687|NCT00261846|O9|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211688|NCT00261846|O8|Outcome|BP-CML Total|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) chronic myelogenous leukemia (CML) who were imatinib (IM) resistant/intolerant (R/I) or Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211689|NCT00261846|O7|Outcome|AP-CML Total|All participants who received bosutinib 500 mg orally once daily in advanced phase (AP) chronic myelogenous leukemia (CML) who were imatinib (IM) resistant/intolerant (R/I) or Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211690|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211904|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211691|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211692|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211693|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211694|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211695|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211696|NCT00261846|O11|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211697|NCT00261846|O10|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211698|NCT00261846|O9|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211699|NCT00261846|O8|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211700|NCT00261846|O7|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211701|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211702|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211703|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211704|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211705|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211706|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211707|NCT00261846|O5|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211708|NCT00261846|O4|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211709|NCT00261846|O3|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1212349|NCT00260689|P1|Participant Flow|Horse ATG/CsA Taper|Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
1211710|NCT00261846|O2|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211711|NCT00261846|O1|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211712|NCT00261846|O5|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211713|NCT00261846|O4|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211714|NCT00261846|O3|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211715|NCT00261846|O2|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211716|NCT00261846|O1|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211717|NCT00261846|O11|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211718|NCT00261846|O10|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211719|NCT00261846|O9|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211720|NCT00261846|O8|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211721|NCT00261846|O7|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211722|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211723|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211724|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211725|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211726|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211727|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211728|NCT00261846|O11|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211729|NCT00261846|O10|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211731|NCT00261846|O8|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211732|NCT00261846|O7|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211733|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211734|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211735|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211736|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211737|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211738|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211739|NCT00261846|O11|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211740|NCT00261846|O10|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211741|NCT00261846|O9|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211742|NCT00261846|O8|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211743|NCT00261846|O7|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211744|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211745|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211746|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211747|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211748|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211749|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211750|NCT00261846|O11|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211751|NCT00261846|O10|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211752|NCT00261846|O9|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211753|NCT00261846|O8|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211754|NCT00261846|O7|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211755|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211756|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211757|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211758|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211759|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211760|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211761|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211762|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211763|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211764|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211765|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211766|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211767|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211970|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211768|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1212100|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1211769|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211770|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211771|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211772|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211773|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211774|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211775|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211776|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211777|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211778|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211779|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211780|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211781|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211782|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211783|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211784|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
1212002|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211785|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1212362|NCT00260533|B3|Baseline|Total|Total of all reporting groups
1212363|NCT00260533|B2|Baseline|Placebo|Placebo
1211786|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211787|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
1211788|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211789|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211790|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
1211791|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211792|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211793|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
1211794|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211795|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211796|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1211797|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
1211798|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211799|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211800|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
1211801|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211802|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1212350|NCT00260689|O3|Outcome|Alemtuzumab|Alemtuzumab (Campath) administered for 10 days
1211839|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211803|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
1211804|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211805|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211806|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
1211807|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211808|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211809|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
1211810|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211811|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211812|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
1211813|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211814|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211815|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
1211816|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211817|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211818|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
1211819|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211820|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211821|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
1211822|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211823|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211824|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
1211825|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211826|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211827|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
1211828|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211829|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211830|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
1211831|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211832|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211833|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
1211834|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211835|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1211836|NCT00261846|O1|Outcome|All Treated Participants|All participants who received single oral dose of bosutinib 400 mg, 500 mg or 600 mg on Day 1 and then bosutinib 400 mg, 500 mg or 600 mg orally once daily continuously from Day 3 up to Week 4.
1211837|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
1211838|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
1212351|NCT00260689|O2|Outcome|Rabbit ATG/CsA|Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
1211840|NCT00261846|E3|Reported Event|Advanced Phase|All participants who received bosutinib 500 mg orally once daily for 48 weeks in advanced phase (AP) and blast phase (BP) chronic myelogenous leukemia (CML), and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).
1211841|NCT00261846|E2|Reported Event|CP3L-CML|All participants who received bosutinib 500 mg orally once daily for 48 weeks in chronic phase third-line (CP3L) chronic myelogenous leukemia (CML), participants were imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R), dasatinib (D) intolerant (I), nilotinib (NI) resistant (R), and dasatinib and nilotinib resistant/intolerant (R/I) or nilotinib intolerant (I).
1211842|NCT00261846|E1|Reported Event|CP2L-CML|All participants who received bosutinib 500 mg orally once daily for 48 weeks in chronic phase second-line (CP2L) chronic myelogenous leukemia (CML), who were imatinib (IM) resistant/refractory (R) and IM intolerant (I).
1211843|NCT00261833|B3|Baseline|Total|Total of all reporting groups
1211844|NCT00261833|B2|Baseline|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
1211845|NCT00261833|B1|Baseline|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
1211846|NCT00261833|P2|Participant Flow|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
1211847|NCT00261833|P1|Participant Flow|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
1211848|NCT00261833|O2|Outcome|Placebo|Placebo: Lyophilized preparation: 60 mg/kg body weight/week intravenous
1211849|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
1211850|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
1211851|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
1211852|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
1211853|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
1211854|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
1211855|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
1211856|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
1211857|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
1211858|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
1211859|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
1211860|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
1211861|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
1211862|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
1211863|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
1211864|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
1211865|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
1211866|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
1211867|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
1211868|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
1211869|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
1211870|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
1211871|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
1211872|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
1211873|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
1211874|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
1211875|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
1211876|NCT00261833|E2|Reported Event|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
1211877|NCT00261833|E1|Reported Event|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
1211878|NCT00261716|B3|Baseline|Total|Total of all reporting groups
1211879|NCT00261716|B2|Baseline|IPS+IE|"Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Illness Education (IE): Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search"
1211880|NCT00261716|B1|Baseline|IPS+VOMI|"Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Vocationally-Oriented Motivational Interviewing (VOMI): Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search"
1211881|NCT00261716|P2|Participant Flow|IPS+IE|"Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Illness Education (IE): Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search"
1211905|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211907|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1212364|NCT00260533|B1|Baseline|Atomoxetine|Atomoxetine
1211882|NCT00261716|P1|Participant Flow|IPS+VOMI|"Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Vocationally-Oriented Motivational Interviewing (VOMI): Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search"
1211883|NCT00261716|O2|Outcome|Not Employed|Participant indicated he/she was not employed at least part-time within one month of scheduled assessment
1211884|NCT00261716|O1|Outcome|Employed|Participant indicated he/she was employed at least part-time within one month of scheduled assessment
1211885|NCT00261716|O2|Outcome|Not Employed|Participant indicated he/she was not employed at least part-time within one month of scheduled assessment
1211886|NCT00261716|O1|Outcome|Employed|Participant indicated he/she was employed at least part-time within one month of scheduled assessment
1211887|NCT00261716|O2|Outcome|Not Employed|Participant indicated he/she was not employed at least part-time within one month of scheduled assessment
1211888|NCT00261716|O1|Outcome|Employed|Participant indicated he/she was employed at least part-time within one month of scheduled assessment
1211889|NCT00261716|O2|Outcome|IPS and IE|"Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching~IPS: Individual Placement and Support Evidence based supported employment~IE: Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search"
1211890|NCT00261716|O1|Outcome|IPS and VOMI|"Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching~IPS: Individual Placement and Support Evidence based supported employment~VOMI: Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search"
1211891|NCT00261716|O2|Outcome|IPS+IE|"Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Illness Education (IE): Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search"
1211892|NCT00261716|O1|Outcome|IPS+VOMI|"Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Vocationally-Oriented Motivational Interviewing (VOMI): Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search"
1211893|NCT00261716|O2|Outcome|IPS+IE|"Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Illness Education (IE): Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search"
1211894|NCT00261716|O1|Outcome|IPS+VOMI|"Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Vocationally-Oriented Motivational Interviewing (VOMI): Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search"
1211895|NCT00261716|O2|Outcome|IPS+IE|"Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Illness Education (IE): Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search"
1211896|NCT00261716|O1|Outcome|IPS+VOMI|"Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Vocationally-Oriented Motivational Interviewing (VOMI): Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search"
1211897|NCT00261716|E2|Reported Event|IPS+IE|"Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Illness Education (IE): Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search"
1211898|NCT00261716|E1|Reported Event|IPS+VOMI|"Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Vocationally-Oriented Motivational Interviewing (VOMI): Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search"
1211899|NCT00261495|B3|Baseline|Total|Total of all reporting groups
1211900|NCT00261495|B2|Baseline|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211901|NCT00261495|B1|Baseline|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211902|NCT00261495|P2|Participant Flow|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1212352|NCT00260689|O1|Outcome|Horse ATG/CsA Taper|Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
1211909|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211910|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211911|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211912|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211913|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211914|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211915|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211916|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211917|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211918|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211919|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211920|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211921|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211922|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211923|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211924|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211925|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211926|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211927|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211928|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211929|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211930|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211931|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211932|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211933|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211934|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211935|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211936|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211937|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1214579|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
1211939|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211940|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211941|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211942|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211943|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211944|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211945|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211946|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211947|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211948|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211949|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211950|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211951|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211952|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211953|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211954|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211955|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211956|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211957|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211958|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211959|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211960|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211961|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211962|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211963|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211964|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211965|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211966|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211967|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211968|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211969|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1214580|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
1211971|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211972|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211973|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211974|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211975|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211976|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211977|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211978|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211979|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211980|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211981|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211982|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211983|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211984|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211985|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211986|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211987|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211988|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211989|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211990|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211991|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211992|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211993|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211994|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211995|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211996|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211997|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1211998|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1211999|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1212000|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1212001|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1214581|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
1212003|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1212004|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1212005|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1212006|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1212007|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1212008|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1212009|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1212010|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1212011|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1212012|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1212013|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1212014|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1212015|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1212016|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1212017|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1212018|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1212019|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1212020|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1212021|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1212022|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1212023|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1212024|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1212025|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1212026|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1212027|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1212028|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1212029|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1212030|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1212031|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1212032|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1212033|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1214582|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
1212034|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1212035|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1212037|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1212038|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1212039|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1212040|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1212041|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1212042|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1212043|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1212044|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1212045|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1212046|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1212047|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1212048|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1212049|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1212050|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1212051|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1212052|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1212053|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1212054|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1212055|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1212056|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1212057|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1212058|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1212059|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1212060|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1212061|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1212062|NCT00261495|E2|Reported Event|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
1212063|NCT00261495|E1|Reported Event|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
1212064|NCT00261443|B3|Baseline|Total|Total of all reporting groups
1212065|NCT00261443|B2|Baseline|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212066|NCT00261443|B1|Baseline|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212067|NCT00261443|P3|Participant Flow|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): 10-mg, 15-mg, or 30-mg doses of aripiprazole and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
1212068|NCT00261443|P2|Participant Flow|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
1212069|NCT00261443|P1|Participant Flow|Pre-Randomized Participants|Phase 1 (2 to 8 Week Screening, Washout and Confirmation of Partial Nonresponse Phase): lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml. Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): 10-mg, 15-mg, or 30-mg doses of aripiprazole and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
1212070|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212071|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212072|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212073|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212074|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212075|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212076|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212077|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212078|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212079|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212080|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212081|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212082|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212083|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212084|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212085|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212086|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212087|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212088|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212089|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212090|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212091|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212092|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212093|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212094|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212095|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212096|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212097|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212231|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212098|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212099|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212365|NCT00260533|P2|Participant Flow|Placebo|Placebo (matched capsules to atomoxetine)
1212101|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212102|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212103|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212104|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212105|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212106|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212107|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212108|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212109|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212110|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212111|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212112|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212113|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212114|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212115|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212116|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212117|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212118|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212119|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212120|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212121|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212122|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212123|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212124|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212125|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212126|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212127|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212128|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212129|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212130|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212353|NCT00260689|O3|Outcome|Alemtuzumab|Alemtuzumab (Campath) administered for 10 days
1212131|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212132|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212133|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212134|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212135|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212136|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212137|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212138|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212139|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212140|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212141|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212142|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212143|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212144|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212145|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212146|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212147|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212148|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212149|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212150|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212151|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212152|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212153|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212154|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212155|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212156|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212157|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212158|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212159|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212160|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212161|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212162|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212163|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1214583|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
1212164|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212165|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212166|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212167|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212168|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212169|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212170|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212171|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212172|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212173|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212174|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212175|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212176|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212177|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212178|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212179|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212180|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212181|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212182|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212183|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212184|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212185|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212186|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212187|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212188|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212189|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212190|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212191|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212192|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212193|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212194|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212195|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212196|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1214584|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
1212197|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212198|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212199|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212200|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212201|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212202|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212203|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212204|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212205|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212206|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212207|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212208|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212209|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212210|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212211|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212212|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212213|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212214|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212215|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212216|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212217|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212218|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212219|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212220|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212221|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212222|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212223|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212224|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212225|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212226|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212227|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212228|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212229|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212230|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212354|NCT00260689|O2|Outcome|Rabbit ATG/CsA|Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
1212232|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212233|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212234|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1214618|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
1212236|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212237|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212238|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212239|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212240|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212241|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212242|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212243|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212244|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212245|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212246|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212247|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212248|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212249|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212250|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212251|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212252|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212253|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212254|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212255|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212256|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212257|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212258|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212259|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212260|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212261|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212262|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212263|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212264|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212265|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212266|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212268|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212269|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212270|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212271|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212272|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212273|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212274|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212275|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212276|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212277|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212278|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212279|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212280|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212281|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212282|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212283|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212284|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212285|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212286|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212287|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212288|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212289|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212290|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212291|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212292|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212293|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212294|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212295|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212296|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212297|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212298|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212299|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212300|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212301|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1214585|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
1212302|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212303|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212304|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212305|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212306|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212307|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212308|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
1212309|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
1212310|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212311|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212312|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212313|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212314|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212315|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212316|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212317|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
1212318|NCT00261443|E5|Reported Event|Extension Phase Aripiprazole|Phase 4 (Extension Phase): 10-mg, 15-mg, or 30-mg doses of aripiprazole and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
1212319|NCT00261443|E4|Reported Event|Extension Phase Placebo|Phase 4 (Extension Phase): matching placebo oral tablets and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
1212320|NCT00261443|E3|Reported Event|Double-Blind Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): 10-mg, 15-mg, or 30-mg doses of aripiprazole and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
1212321|NCT00261443|E2|Reported Event|Double-Blind Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
1212322|NCT00261443|E1|Reported Event|Single-Blind Aripiprazole|Phase 1 (2 to 8 Week Screening, Washout and Confirmation of Partial Nonresponse Phase): lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml. Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): 10-mg, 15-mg, or 30-mg doses of aripiprazole and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
1212323|NCT00260962|B3|Baseline|Total|Total of all reporting groups
1212324|NCT00260962|B2|Baseline|Olanzapine Plus Day Hospital|"After a 2-week baseline period, Olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of 10 mg/day. Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.~Olanzapine: After a 2-week baseline period, olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of at 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of of 10 mg/day.~Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
1212325|NCT00260962|B1|Baseline|Placebo Plus Day Hospital|"After a 2-week baseline period, placebo was administered for 10 weeks (weeks 3-12 of the study). Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.~Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
1212326|NCT00260962|P2|Participant Flow|Olanzapine Plus Day Hospital|"After a 2-week baseline period, Olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of 10 mg/day. Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.~Olanzapine: After a 2-week baseline period, olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of at 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of of 10 mg/day.~Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
1212355|NCT00260689|O1|Outcome|Horse ATG/CsA Taper|Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
1212356|NCT00260689|O3|Outcome|Alemtuzumab|Alemtuzumab (Campath) administered for 10 days
1212357|NCT00260689|O2|Outcome|Rabbit ATG/CsA|Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
1212327|NCT00260962|P1|Participant Flow|Placebo Plus Day Hospital|"After a 2-week baseline period, placebo was administered for 10 weeks (weeks 3-12 of the study). Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.~Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
1212366|NCT00260533|P1|Participant Flow|Atomoxetine|Atomoxetine 40-100 mg per day
1212367|NCT00260533|O2|Outcome|Placebo|Placebo
1212368|NCT00260533|O1|Outcome|Atomoxetine|Atomoxetine
1212369|NCT00260533|E2|Reported Event|Placebo|Placebo
1212370|NCT00260533|E1|Reported Event|Atomoxetine|Atomoxetine
1212328|NCT00260962|O2|Outcome|Olanzapine Plus Day Hospital|"After a 2-week baseline period, Olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of 10 mg/day. Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.~Olanzapine: After a 2-week baseline period, olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of at 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of of 10 mg/day.~Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
1212329|NCT00260962|O1|Outcome|Placebo Plus Day Hospital|"After a 2-week baseline period, placebo was administered for 10 weeks (weeks 3-12 of the study). Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.~Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
1212330|NCT00260962|O2|Outcome|Olanzapine Plus Day Hospital|"After a 2-week baseline period, Olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of 10 mg/day. Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.~Olanzapine: After a 2-week baseline period, olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of at 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of of 10 mg/day.~Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
1212331|NCT00260962|O1|Outcome|Placebo Plus Day Hospital|"After a 2-week baseline period, placebo was administered for 10 weeks (weeks 3-12 of the study). Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.~Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
1212332|NCT00260962|E2|Reported Event|Olanzapine Plus Day Hospital|"After a 2-week baseline period, Olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of 10 mg/day. Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.~Olanzapine: After a 2-week baseline period, olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of at 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of of 10 mg/day.~Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
1212333|NCT00260962|E1|Reported Event|Placebo Plus Day Hospital|"After a 2-week baseline period, placebo was administered for 10 weeks (weeks 3-12 of the study). Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.~Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy."
1212334|NCT00260832|B3|Baseline|Total|Total of all reporting groups
1212335|NCT00260832|B2|Baseline|Dacogen (Decitabine) Only|20 mg/m^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.
1212336|NCT00260832|B1|Baseline|Cytarabine or Supportive Care|Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)
1212337|NCT00260832|P2|Participant Flow|Dacogen (Decitabine) Only|20 mg/m^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.
1212338|NCT00260832|P1|Participant Flow|Cytarabine or Supportive Care|Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)
1212339|NCT00260832|O2|Outcome|Dacogen (Decitabine) Only|20 mg/m^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.
1212340|NCT00260832|O1|Outcome|Cytarabine or Supportive Care|Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)
1212341|NCT00260832|E2|Reported Event|Dacogen (Decitabine) Only|20 mg/m^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.
1212342|NCT00260832|E1|Reported Event|Cytarabine or Supportive Care|Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)
1212343|NCT00260689|B4|Baseline|Total|Total of all reporting groups
1212344|NCT00260689|B3|Baseline|Alemtuzumab|Alemtuzumab (Campath) administered for 10 days
1212345|NCT00260689|B2|Baseline|Rabbit ATG/CsA|Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
1212346|NCT00260689|B1|Baseline|Horse ATG/CsA Taper|Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
1212347|NCT00260689|P3|Participant Flow|Alemtuzumab|Alemtuzumab (Campath) administered for 10 days
1212348|NCT00260689|P2|Participant Flow|Rabbit ATG/CsA|Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
1212429|NCT00260065|O1|Outcome|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.
1212358|NCT00260689|O1|Outcome|Horse ATG/CsA Taper|Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
1212359|NCT00260689|E3|Reported Event|Alemtuzumab|Alemtuzumab (Campath) administered for 10 days
1212360|NCT00260689|E2|Reported Event|Rabbit ATG/CsA|Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
1212373|NCT00260429|B1|Baseline|AA4500|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
1212374|NCT00260429|P2|Participant Flow|Placebo|
1212375|NCT00260429|P1|Participant Flow|AA4500|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
1212376|NCT00260429|O2|Outcome|Placebo|
1212377|NCT00260429|O1|Outcome|AA4500|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
1212378|NCT00260429|E2|Reported Event|Placebo|
1212379|NCT00260429|E1|Reported Event|AA4500|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
1212380|NCT00260208|B3|Baseline|Total|Total of all reporting groups
1212381|NCT00260208|B2|Baseline|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
1212382|NCT00260208|B1|Baseline|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
1212383|NCT00260208|P2|Participant Flow|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
1212384|NCT00260208|P1|Participant Flow|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
1212385|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
1212386|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
1212387|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
1212388|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
1212389|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
1212427|NCT00260065|P1|Participant Flow|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.
1214586|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
1212390|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
1212391|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
1212434|NCT00259857|P2|Participant Flow|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
1213339|NCT00256698|O1|Outcome|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
1212392|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
1212393|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
1212394|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
1212395|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
1212396|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
1212397|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
1212398|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
1212399|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
1212400|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
1212401|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
1212402|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
1212403|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
1212587|NCT00259090|B1|Baseline|Fulvestrant|Fulvestrant 500 mg once monthly injection
1212404|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
1212405|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
1212406|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
1212407|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
1212408|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
1212409|NCT00260208|E2|Reported Event|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
1212410|NCT00260208|E1|Reported Event|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
1212411|NCT00260195|B3|Baseline|Total|Total of all reporting groups
1212412|NCT00260195|B2|Baseline|Wait-list Control Group|Students assigned to this group waited while the experimental arm received SSET, and then completed the first follow-up assessment. They then received SSET between the first and second follow-up assessment.
1212413|NCT00260195|B1|Baseline|School-based Cognitive Behavioral Support Group|Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
1212414|NCT00260195|P2|Participant Flow|Wait-list Control Group|Students assigned to this group waited while the experimental arm received SSET, and then completed the first follow-up assessment. They then received SSET between the first and second follow-up assessment.
1212415|NCT00260195|P1|Participant Flow|School-based Cognitive Behavioral Support Group|Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
1212416|NCT00260195|O2|Outcome|Wait-list Control Group|Waiting list
1212417|NCT00260195|O1|Outcome|School-based Cognitive Behavioral Support Group|Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
1212418|NCT00260195|O2|Outcome|Wait-list Control Group|Waiting list
1212419|NCT00260195|O1|Outcome|School-based Cognitive Behavioral Support Group|Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
1212420|NCT00260195|O2|Outcome|Wait-list Control Group|Waiting list
1212421|NCT00260195|O1|Outcome|School-based Cognitive Behavioral Support Group|Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
1212422|NCT00260195|O2|Outcome|Wait-list Control Group|Students assigned to this group waited while the experimental arm received SSET, and then completed the first follow-up assessment. They then received SSET between the first and second follow-up assessment.
1212423|NCT00260195|O1|Outcome|School-based Cognitive Behavioral Support Group|Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
1212424|NCT00260195|E2|Reported Event|Wait-list Control Group|Students assigned to this group waited while the experimental arm received SSET, and then completed the first follow-up assessment. They then received SSET between the first and second follow-up assessment.
1212425|NCT00260195|E1|Reported Event|School-based Cognitive Behavioral Support Group|Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
1212426|NCT00260065|B1|Baseline|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.
1212588|NCT00259090|P3|Participant Flow|Anastrozole|Anastrozole 1 mg once daily tablet
1212430|NCT00260065|E1|Reported Event|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.
1212431|NCT00259857|B3|Baseline|Total|Total of all reporting groups
1212432|NCT00259857|B2|Baseline|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
1212433|NCT00259857|B1|Baseline|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
1212463|NCT00259649|B1|Baseline|Eletriptan|Perimenstrual oral eletriptan 20 mg three times daily starting two days prior to the expected onset of menstruation and continued for a total of 6 days for 3 consecutive months
1212435|NCT00259857|P1|Participant Flow|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
1212436|NCT00259857|O2|Outcome|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
1212437|NCT00259857|O1|Outcome|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
1212438|NCT00259857|O2|Outcome|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
1212439|NCT00259857|O1|Outcome|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
1212440|NCT00259857|O2|Outcome|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
1212441|NCT00259857|O1|Outcome|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
1212442|NCT00259857|O2|Outcome|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
1212443|NCT00259857|O1|Outcome|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
1212444|NCT00259857|O2|Outcome|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
1212445|NCT00259857|O1|Outcome|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
1212446|NCT00259857|O2|Outcome|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
1212447|NCT00259857|O1|Outcome|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
1212448|NCT00259857|E2|Reported Event|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
1212449|NCT00259857|E1|Reported Event|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
1212450|NCT00259740|B3|Baseline|Total|Total of all reporting groups
1212451|NCT00259740|B2|Baseline|Denosumab 120 mg Q4W - Relapsed|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma
1212452|NCT00259740|B1|Baseline|Denosumab 120 mg Q4W - Plateau-Phase|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma
1212453|NCT00259740|P2|Participant Flow|Denosumab 120 mg Q4W - Relapsed|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma
1212454|NCT00259740|P1|Participant Flow|Denosumab 120 mg Q4W - Plateau-Phase|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma
1212455|NCT00259740|O2|Outcome|Denosumab 120 mg Q4W - Relapsed|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma
1212456|NCT00259740|O1|Outcome|Denosumab 120 mg Q4W - Plateau-Phase|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma
1212457|NCT00259740|O2|Outcome|Denosumab 120 mg Q4W - Relapsed|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma
1214587|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
1212458|NCT00259740|O1|Outcome|Denosumab 120 mg Q4W - Plateau-Phase|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma
1212459|NCT00259740|O2|Outcome|Denosumab 120 mg Q4W - Relapsed|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma
1212460|NCT00259740|O1|Outcome|Denosumab 120 mg Q4W - Plateau-Phase|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma
1212461|NCT00259740|E2|Reported Event|Denosumab 120 mg Q4W - Plateau-Phase|
1212462|NCT00259740|E1|Reported Event|Denosumab 120 mg Q4W - Relapsed|
1212598|NCT00259090|O2|Outcome|Fulvestrant + Anastrozole|Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
1212464|NCT00259649|P1|Participant Flow|Eletriptan|Perimenstrual oral eletriptan 20 mg three times daily starting two days prior to the expected onset of menstruation and continued for a total of 6 days for 3 consecutive months
1212465|NCT00259649|O1|Outcome|Eletriptan|Perimenstrual oral eletriptan 20 mg three times daily starting two days prior to the expected onset of menstruation and continued for a total of 6 days for 3 consecutive months
1212466|NCT00259649|E1|Reported Event|Eletriptan|Perimenstrual oral eletriptan 20 mg three times daily starting two days prior to the expected onset of menstruation and continued for a total of 6 days for 3 consecutive months
1212467|NCT00259610|B5|Baseline|Total|Total of all reporting groups
1212468|NCT00259610|B4|Baseline|MTX + Placebo SSZ + HCQ(ST)|methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
1212469|NCT00259610|B3|Baseline|MTX + Placebo Entaneracept|methotrexate (MTX) or MTX + Etanercept
1212470|NCT00259610|B2|Baseline|MTX+ Active SSZ +HCQ|methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
1212471|NCT00259610|B1|Baseline|MTX + Active Etanercept|Methotrexate (MTX) + etanercept
1212472|NCT00259610|P4|Participant Flow|MTX + Placebo SSZ + HCQ(ST)|Methotrexate (MTX)5mg -20mg/qw by mouth(within 12 weeks of entry in study) + sulfasalazine (SSZ) 500mg qd - 1000mg 2qd by mouth /hydroxychloroquine (HCQ)200mg 2qd by mouth
1212473|NCT00259610|P3|Participant Flow|MTX + Placebo Entaneracept|Methotrexate (MTX)5mg -20mg/qw by mouth(within 12 weeks of entry in study) + Etanercept(Placebo) 50mg/qw by injection
1212474|NCT00259610|P2|Participant Flow|MTX+ Active SSZ +HCQ|methotrexate (MTX)20mg/qw by mouth(within 12 weeks of entry in study) + sulfasalazine (SSZ) 500mg qd - 1000mg 2qd by mouth /hydroxychloroquine (HCQ)200mg 2qd by mouth
1212475|NCT00259610|P1|Participant Flow|MTX + Active Etanercept|Methotrexate (MTX)5mg -20mg/qw by mouth(within 12 weeks of entry in study) + etanercept 50mg/qw by injection
1212476|NCT00259610|O4|Outcome|MTX + Step-up SSZ + HCQ(ST)|methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
1212477|NCT00259610|O3|Outcome|MTX + Step-up Etanercept|methotrexate (MTX) or MTX + Etanercept
1212478|NCT00259610|O2|Outcome|MTX+ Immediate SSZ +HCQ|methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
1212479|NCT00259610|O1|Outcome|MTX + Immediate Etanercept|Methotrexate (MTX) + etanercept
1212480|NCT00259610|O4|Outcome|MTX + Step-up SSZ + HCQ(ST)|methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
1212481|NCT00259610|O3|Outcome|MTX + Step-up Etanercept|methotrexate (MTX) or MTX + Etanercept
1212482|NCT00259610|O2|Outcome|MTX+ Immediate SSZ +HCQ|methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
1212483|NCT00259610|O1|Outcome|MTX + Immediate Etanercept|Methotrexate (MTX) + etanercept
1212484|NCT00259610|E4|Reported Event|MTX + Placebo SSZ + HCQ(ST)|methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
1212485|NCT00259610|E3|Reported Event|MTX + Placebo Entaneracept|methotrexate (MTX) or MTX + Etanercept
1212486|NCT00259610|E2|Reported Event|MTX+ Active SSZ +HCQ|methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
1212487|NCT00259610|E1|Reported Event|MTX + Active Etanercept|Methotrexate (MTX) + etanercept
1212488|NCT00259298|B1|Baseline|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
1212489|NCT00259298|P1|Participant Flow|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
1212490|NCT00259298|O1|Outcome|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
1212491|NCT00259298|O1|Outcome|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
1212492|NCT00259298|O1|Outcome|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
1212493|NCT00259298|O1|Outcome|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
1212494|NCT00259298|O1|Outcome|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
1212495|NCT00259298|E1|Reported Event|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
1212496|NCT00259285|B1|Baseline|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
1212497|NCT00259285|P1|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
1212498|NCT00259285|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
1212499|NCT00259285|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
1212500|NCT00259285|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
1212501|NCT00259285|E1|Reported Event|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
1212502|NCT00259272|B5|Baseline|Total|Total of all reporting groups
1212503|NCT00259272|B4|Baseline|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
1212504|NCT00259272|B3|Baseline|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
1212505|NCT00259272|B2|Baseline|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
1212506|NCT00259272|B1|Baseline|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
1212507|NCT00259272|P4|Participant Flow|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
1212508|NCT00259272|P3|Participant Flow|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
1212509|NCT00259272|P2|Participant Flow|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
1212510|NCT00259272|P1|Participant Flow|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
1212511|NCT00259272|O3|Outcome|Cumulative|
1212512|NCT00259272|O2|Outcome|Proportion|
1212513|NCT00259272|O1|Outcome|Eigen Value|
1212514|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
1212515|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
1212516|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
1212517|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
1212518|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
1212519|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
1212520|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
1212521|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
1212522|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
1212523|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
1212524|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
1212525|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
1212526|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
1212527|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
1212528|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
1212529|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
1212530|NCT00259272|O3|Outcome|Neither|As assessed by the investigator according to his clinical experience.
1212531|NCT00259272|O2|Outcome|Thymic Hyper-Reactivity|As assessed by the investigator according to his clinical experience.
1212532|NCT00259272|O1|Outcome|Thymic Hypo-Reactivity|As assessed by the investigator according to his clinical experience.
1212533|NCT00259272|O3|Outcome|Neither|As assessed by the investigator according to his clinical experience.
1212534|NCT00259272|O2|Outcome|Thymic Hyper-Reactivity|As assessed by the investigator according to his clinical experience.
1212535|NCT00259272|O1|Outcome|Thymic Hypo-Reactivity|As assessed by the investigator according to his clinical experience.
1212536|NCT00259272|O3|Outcome|Neither|As assessed by the investigator according to his clinical experience.
1212537|NCT00259272|O2|Outcome|Thymic Hyper-Reactivity|As assessed by the investigator according to his clinical experience.
1212538|NCT00259272|O1|Outcome|Thymic Hypo-Reactivity|As assessed by the investigator according to his clinical experience.
1212539|NCT00259272|O3|Outcome|Neither|As assessed by the investigator according to his clinical experience.
1212540|NCT00259272|O2|Outcome|Thymic Hyper-Reactivity|As assessed by the investigator according to his clinical experience.
1212541|NCT00259272|O1|Outcome|Thymic Hypo-Reactive|As assessed by the investigator according to his clinical experience.
1212542|NCT00259272|O1|Outcome|Weight Gain Subgroup|Patients who gained more than 7% of body weight during the study.
1212543|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
1212544|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
1212545|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
1212950|NCT00257686|O1|Outcome|Pitavastatin 1 mg|Pitavastatin 1 mg once daily
1212546|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
1212547|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
1212548|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
1212549|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
1212550|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
1212551|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
1212599|NCT00259090|O1|Outcome|Fulvestrant|Fulvestrant 500 mg once monthly injection
1212552|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
1212553|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
1212554|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
1212555|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
1212556|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
1212557|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
1212558|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
1212559|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
1212560|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
1212561|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
1212562|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
1212563|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
1212564|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
1212565|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
1212566|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
1212567|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
1212568|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
1212569|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
1212570|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
1212571|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
1212572|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
1212573|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
1212574|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
1212575|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
1212576|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
1212577|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
1212578|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
1212579|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
1212580|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
1212581|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
1212582|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
1212583|NCT00259272|E1|Reported Event|Olanzapine|Olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks.
1212584|NCT00259090|B4|Baseline|Total|Total of all reporting groups
1212585|NCT00259090|B3|Baseline|Anastrozole|Anastrozole 1 mg once daily tablet
1212586|NCT00259090|B2|Baseline|Fulvestrant + Anastrozole|Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
1212589|NCT00259090|P2|Participant Flow|Fulvestrant + Anastrozole|Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
1212590|NCT00259090|P1|Participant Flow|Fulvestrant|Fulvestrant 500 mg once monthly injection
1212591|NCT00259090|O3|Outcome|Anastrozole|Anastrozole 1 mg once daily tablet
1212592|NCT00259090|O2|Outcome|Fulvestrant + Anastrozole|Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
1212593|NCT00259090|O1|Outcome|Fulvestrant|Fulvestrant 500 mg once monthly injection
1212594|NCT00259090|O3|Outcome|Anastrozole|Anastrozole 1 mg once daily tablet
1212595|NCT00259090|O2|Outcome|Fulvestrant + Anastrozole|Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
1212596|NCT00259090|O1|Outcome|Fulvestrant|Fulvestrant 500 mg once monthly injection
1212597|NCT00259090|O3|Outcome|Anastrozole|Anastrozole 1 mg once daily tablet
1213340|NCT00256698|O2|Outcome|Anastrozole|Anastrozole 1 mg
1212601|NCT00259090|E2|Reported Event|Fulvestrant + Anastrozole|Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
1212602|NCT00259090|E1|Reported Event|Fulvestrant|Fulvestrant 500 mg once monthly injection
1212603|NCT00259012|B3|Baseline|Total|Total of all reporting groups
1212604|NCT00259012|B2|Baseline|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
1212605|NCT00259012|B1|Baseline|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
1212606|NCT00259012|P2|Participant Flow|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
1212607|NCT00259012|P1|Participant Flow|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
1212608|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
1212609|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
1212610|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
1212611|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
1212612|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
1212613|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
1212614|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
1212615|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
1212616|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
1212617|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
1212618|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
1212619|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
1212717|NCT00258817|O1|Outcome|Influenza Vaccine-naive Group|Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.
1212620|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
1212621|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
1212622|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
1212623|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
1214619|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
1212624|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
1212625|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
1212626|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
1212627|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
1212628|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
1212629|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
1212630|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
1212631|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
1212632|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
1212633|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
1212634|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
1212635|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
1212636|NCT00259012|E2|Reported Event|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
1212637|NCT00259012|E1|Reported Event|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
1212638|NCT00258908|B1|Baseline|ADACEL™ Group|Participants received 1 dose of ADACEL™ (TdcP vaccine)
1212639|NCT00258908|P1|Participant Flow|ADACEL™ Group|Participants received 1 dose of ADACEL™ (TdcP vaccine)
1212640|NCT00258908|O1|Outcome|ADACEL™ Group|Participants received 1 dose of ADACEL™ (TdcP vaccine)
1212641|NCT00258908|O1|Outcome|ADACEL™ Group|Participants received 1 dose of ADACEL™ (TdcP vaccine)
1212642|NCT00258908|O1|Outcome|ADACEL™ Group|Participants received 1 dose of ADACEL™ (TdcP vaccine)
1212643|NCT00258908|E1|Reported Event|ADACEL™ Group|Participants received 1 dose of ADACEL™ (TdcP vaccine)
1212644|NCT00258895|B3|Baseline|Total|Total of all reporting groups
1212645|NCT00258895|B2|Baseline|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
1212646|NCT00258895|B1|Baseline|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
1212647|NCT00258895|P2|Participant Flow|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
1212648|NCT00258895|P1|Participant Flow|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
1212649|NCT00258895|O2|Outcome|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
1212650|NCT00258895|O1|Outcome|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
1212651|NCT00258895|O2|Outcome|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
1212652|NCT00258895|O1|Outcome|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
1214620|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
1212653|NCT00258895|O2|Outcome|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
1212654|NCT00258895|O1|Outcome|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
1212655|NCT00258895|O2|Outcome|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
1212656|NCT00258895|O1|Outcome|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
1212657|NCT00258895|O2|Outcome|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
1212658|NCT00258895|O1|Outcome|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
1212659|NCT00258895|E2|Reported Event|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
1212660|NCT00258895|E1|Reported Event|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
1212661|NCT00258882|B3|Baseline|Total|Total of all reporting groups
1212662|NCT00258882|B2|Baseline|Control Groups|Non-pregnant individuals matched by age to individuals who received Td vaccine but no live virus vaccine during the year prior to initiation of the study during the same month as Adacel vaccine recipient, but 1 year earlier.
1212663|NCT00258882|B1|Baseline|Adacel Vaccine Group|"Participants who received Adacel vaccine during the study period were sub-grouped as 1) pregnant at the time of vaccination or who became pregnant within 28 days after vaccination and 2) non-pregnant recipients classified by age at vaccination.~Each non-pregnant recipient served as their own control for evaluation of acute events. Rates of events occurring during Day 0 to 60 following vaccination were compared to rates of events occurring during Day 61 to 120 following vaccination (Short-term surveillance)"
1212664|NCT00258882|P2|Participant Flow|Control Groups|For each pregnant individual receiving Adacel vaccine, 3 control individuals not given Adacel vaccine were matched on age and month of their first positive pregnancy test. For non-pregnant individuals, age-matched individuals were identified who received Td vaccine but no live virus vaccine during the year prior to initiation of the study during the same month as Adacel vaccine recipient, but 1 year earlier.
1212665|NCT00258882|P1|Participant Flow|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period were sub-grouped as 1) pregnant at the time of vaccination or who became pregnant within 28 days after vaccination and 2) non-pregnant recipients classified by age at vaccination.
1212666|NCT00258882|O2|Outcome|Control Groups|Age matched pregnant controls who did not receive Adacel vaccine.
1212667|NCT00258882|O1|Outcome|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period and were pregnant at the time of vaccination or became pregnant within 28 days after vaccination
1212668|NCT00258882|O2|Outcome|Control Groups|Age matched pregnant controls who did not receive Adacel vaccine.
1212669|NCT00258882|O1|Outcome|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period and were pregnant at the time of vaccination or became pregnant within 28 days after vaccination.
1212670|NCT00258882|O2|Outcome|Control Groups|Age matched participants who received Td vaccine but no live virus vaccine, during the year prior to initiation of study during the same month as the Adacel vaccine recipient, 1 year earlier.
1212671|NCT00258882|O1|Outcome|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period.
1212672|NCT00258882|O2|Outcome|Control Groups|Age matched participants who received Td vaccine but no live virus vaccine, during the year prior to initiation of study during the same month as the Adacel vaccine recipient, 1 year earlier.
1212673|NCT00258882|O1|Outcome|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period.
1212674|NCT00258882|O2|Outcome|Control Groups|Age matched participants who received Td vaccine but no live virus vaccine, during the year prior to initiation of study during the same month as the Adacel vaccine recipient, 1 year earlier.
1212675|NCT00258882|O1|Outcome|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period.
1212676|NCT00258882|O2|Outcome|Control Groups|Age matched participants who received Td vaccine but no live virus vaccine, during the year prior to initiation of study during the same month as the Adacel vaccine recipient, 1 year earlier.
1212677|NCT00258882|O1|Outcome|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period.
1212678|NCT00258882|E1|Reported Event|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period. They are sub-grouped as those pregnant at the time of vaccination with Adacel or who became pregnant within 28 days after vaccination and other recipients are classified by age at vaccination.
1212679|NCT00258856|B5|Baseline|Total|Total of all reporting groups
1212680|NCT00258856|B4|Baseline|Meningococcal Vaccine-naïve Group 4|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination
1212681|NCT00258856|B3|Baseline|Meningococcal Vaccine-naïve Group 3|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.
1212682|NCT00258856|B2|Baseline|Menactra® Group 2|"Participants received Menactra® in Study 603-02.~Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination"
1212683|NCT00258856|B1|Baseline|Menactra® Group 1|"Participants received Menactra® in Study 603-02.~Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination"
1212684|NCT00258856|P4|Participant Flow|Meningococcal Vaccine-naïve Group 4|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination.
1212829|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212685|NCT00258856|P3|Participant Flow|Meningococcal Vaccine-naïve Group 3|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.
1212686|NCT00258856|P2|Participant Flow|Menactra® Group 2|"Participants received Menactra® in Study 603-02.~Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination"
1212687|NCT00258856|P1|Participant Flow|Menactra® Group 1|"Participants received Menactra® in Study 603-02.~Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination"
1212688|NCT00258856|O4|Outcome|Meningococcal Vaccine-naïve Group 4|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination
1212689|NCT00258856|O3|Outcome|Meningococcal Vaccine-naïve Group 3|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.
1212690|NCT00258856|O2|Outcome|Menactra® Group 2|"Participants received Menactra® in Study 603-02.~Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination"
1212691|NCT00258856|O1|Outcome|Menactra® Group 1|"Participants received Menactra® in Study 603-02.~Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination"
1212692|NCT00258856|E4|Reported Event|Meningococcal Vaccine-naïve Group 4|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination
1212693|NCT00258856|E3|Reported Event|Meningococcal Vaccine-naïve Group 3|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.
1212694|NCT00258856|E2|Reported Event|Menactra® Group 2|"Participants received Menactra® in Study 603-02.~Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination"
1212695|NCT00258856|E1|Reported Event|Menactra® Group 1|"Participants received Menactra® in Study 603-02.~Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination"
1212696|NCT00258830|B3|Baseline|Total|Total of all reporting groups
1212697|NCT00258830|B2|Baseline|Age 60 Years and Older|Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
1212698|NCT00258830|B1|Baseline|Age 18 to 59 Years|Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
1212699|NCT00258830|P2|Participant Flow|Age 60 Years and Older|Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
1212700|NCT00258830|P1|Participant Flow|Age 18 to 59 Years|Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
1212701|NCT00258830|O2|Outcome|Age 60 Years and Older|Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
1212702|NCT00258830|O1|Outcome|Age 18 to 59 Years|Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
1212703|NCT00258830|O2|Outcome|Age 60 Years and Older|Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
1212704|NCT00258830|O1|Outcome|Age 18 to 59 Years|Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
1212705|NCT00258830|O2|Outcome|Age 60 Years and Older|Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
1212706|NCT00258830|O1|Outcome|Age 18 to 59 Years|Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
1212707|NCT00258830|O2|Outcome|Age 60 Years and Older|Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
1212708|NCT00258830|O1|Outcome|Age 18 to 59 Years|Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
1212709|NCT00258830|E2|Reported Event|Age 60 Years and Older|Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
1212710|NCT00258830|E1|Reported Event|Age 18 to 59 Years|Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
1212711|NCT00258817|B3|Baseline|Total|Total of all reporting groups
1212712|NCT00258817|B2|Baseline|Influenza Vaccine-primed Group|Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
1212713|NCT00258817|B1|Baseline|Influenza Vaccine-naive Group|Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.
1212714|NCT00258817|P2|Participant Flow|Influenza Vaccine-primed Group|Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
1212715|NCT00258817|P1|Participant Flow|Influenza Vaccine-naive Group|Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.
1212716|NCT00258817|O2|Outcome|Influenza Vaccine-primed Group|Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
1214588|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
1212718|NCT00258817|O2|Outcome|Influenza Vaccine-primed Group|Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
1212719|NCT00258817|O1|Outcome|Influenza Vaccine-naive Group|Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.
1212720|NCT00258817|O2|Outcome|Influenza Vaccine-primed Group|Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
1212721|NCT00258817|O1|Outcome|Influenza Vaccine-naive Group|Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.
1212722|NCT00258817|E2|Reported Event|Influenza Vaccine-primed Group|Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
1212723|NCT00258817|E1|Reported Event|Influenza Vaccine-naive Group|Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.
1212725|NCT00258674|B3|Baseline|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
1212726|NCT00258674|B2|Baseline|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
1212727|NCT00258674|B1|Baseline|Claims|Physician feedback of patient process measures using Medicare claims data
1212728|NCT00258674|P3|Participant Flow|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
1212729|NCT00258674|P2|Participant Flow|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
1212730|NCT00258674|P1|Participant Flow|Claims|Physician feedback of patient process measures using Medicare claims data
1212731|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
1212732|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
1212733|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
1212734|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
1212735|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
1212736|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
1212737|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
1212738|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
1212739|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
1212740|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
1212741|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
1212742|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
1212743|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
1212744|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
1212745|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
1212746|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
1212747|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
1212748|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
1212749|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
1212750|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
1212751|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
1212752|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
1212753|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
1212754|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
1212755|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
1212756|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
1212757|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
1212944|NCT00257686|P1|Participant Flow|Pitavastatin 1 mg|Pitavastatin 1 mg once daily
1212758|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
1212759|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
1212760|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
1212761|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
1212762|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
1212763|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
1212830|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1212764|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
1212765|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
1212766|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
1212767|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
1212768|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
1212769|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
1212770|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
1212771|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
1212772|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
1212773|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
1212774|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
1212775|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
1212776|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
1212777|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
1212778|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
1212779|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
1212780|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
1212781|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
1212782|NCT00258674|E3|Reported Event|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
1212783|NCT00258674|E2|Reported Event|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
1212784|NCT00258674|E1|Reported Event|Claims|Physician feedback of patient process measures using Medicare claims data
1212785|NCT00258440|B4|Baseline|Total|Total of all reporting groups
1212786|NCT00258440|B3|Baseline|Interval Dosing (Epoetin Alfa) Non PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have NOT consented to pharmacokinetics (PK) testing.
1212787|NCT00258440|B2|Baseline|Interval Dosing (Epoetin Alfa) PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have consented to pharmacokinetics (PK) testing.
1212788|NCT00258440|B1|Baseline|Weekly Procrit (Epoetin Alfa) Dosing|Patients receive epoetin alfa subcutaneously (SC) once weekly. Treatment continues for 24 weeks in the absence of unacceptable toxicity. Patients then proceed to maintenance therapy.
1212789|NCT00258440|P3|Participant Flow|Interval Dosing (Epoetin Alfa) Non PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have NOT consented to pharmacokinetics (PK) testing.
1212790|NCT00258440|P2|Participant Flow|Interval Dosing (Epoetin Alfa) PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have consented to pharmacokinetics (PK) testing.
1212791|NCT00258440|P1|Participant Flow|Weekly Procrit (Epoetin Alfa) Dosing|Patients receive epoetin alfa subcutaneously (SC) once weekly. Treatment continues for 24 weeks in the absence of unacceptable toxicity. Patients then proceed to maintenance therapy.
1212792|NCT00258440|O3|Outcome|Interval Dosing (Epoetin Alfa) Non PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have NOT consented to pharmacokinetics (PK) testing.
1212793|NCT00258440|O2|Outcome|Interval Dosing (Epoetin Alfa) PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have consented to pharmacokinetics (PK) testing.
1214589|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
1212794|NCT00258440|O1|Outcome|Weekly Procrit (Epoetin Alfa) Dosing|Patients receive epoetin alfa subcutaneously (SC) once weekly. Treatment continues for 24 weeks in the absence of unacceptable toxicity. Patients then proceed to maintenance therapy.
1212795|NCT00258440|O3|Outcome|Interval Dosing (Epoetin Alfa) Non PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have NOT consented to pharmacokinetics (PK) testing.
1212796|NCT00258440|O2|Outcome|Interval Dosing (Epoetin Alfa) PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have consented to pharmacokinetics (PK) testing.
1212797|NCT00258440|O1|Outcome|Weekly Procrit (Epoetin Alfa) Dosing|Patients receive epoetin alfa subcutaneously (SC) once weekly. Treatment continues for 24 weeks in the absence of unacceptable toxicity. Patients then proceed to maintenance therapy.
1212798|NCT00258440|E3|Reported Event|Interval Dosing (Epoetin Alfa) Non PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have NOT consented to pharmacokinetics (PK) testing.
1212799|NCT00258440|E2|Reported Event|Interval Dosing (Epoetin Alfa) PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have consented to pharmacokinetics (PK) testing.
1212800|NCT00258440|E1|Reported Event|Weekly Procrit (Epoetin Alfa) Dosing|Patients receive epoetin alfa subcutaneously (SC) once weekly. Treatment continues for 24 weeks in the absence of unacceptable toxicity. Patients then proceed to maintenance therapy.
1212801|NCT00258362|B1|Baseline|Patients With Endometrial Cancer|Patients with advanced or recurrent endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin. This group excludes those patients with recurrent endometrial cancer.
1212802|NCT00258362|P1|Participant Flow|Patients With Endometrial Cancer|Patients with advanced or recurrent endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin.
1212803|NCT00258362|O1|Outcome|Patients With Endometrial Cancer|Patients with advanced or recurrent endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin.
1212804|NCT00258362|O1|Outcome|Patients With Endometrial Cancer|Patients with advanced endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin.
1212805|NCT00258362|E1|Reported Event|Patients With Endometrial Cancer|Patients with advanced endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin.
1212806|NCT00258349|B1|Baseline|Vorinostat +Trastuzumab|Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks; Vorinostat: 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle.
1212807|NCT00258349|P1|Participant Flow|Vorinostat +Trastuzumab|Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks; Vorinostat: 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle.
1212808|NCT00258349|O1|Outcome|Vorinostat +Trastuzumab|Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks; Vorinostat 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle
1212809|NCT00258349|O1|Outcome|Vorinostat +Trastuzumab|Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks; Vorinostat 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle
1212810|NCT00258349|O1|Outcome|Vorinostat +Trastuzumab|"Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks;~Vorinostat 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle"
1212811|NCT00258349|E2|Reported Event|Vorinostat +Trastuzumab (Phase I)|phase I patients for identify maximum tolerated dose
1212812|NCT00258349|E1|Reported Event|Vorinostat +Trastuzumab (Phase II)|Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks; Vorinostat 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle
1212813|NCT00258310|B1|Baseline|Capecitabine|"Capecitabine 1000mg/day for one year~capecitabine~adjuvant therapy"
1212814|NCT00258310|P1|Participant Flow|Capecitabine|"Capecitabine 1000mg/day for one year~capecitabine~adjuvant therapy"
1212815|NCT00258310|O1|Outcome|Capecitabine|"Capecitabine 1000mg/day for one year~capecitabine~adjuvant therapy"
1212816|NCT00258310|E1|Reported Event|Capcitabine|"Caoecutabube 1000mg/day for one year~capecitabine~adjuvant therapy"
1212817|NCT00258206|B1|Baseline|Rituximab + Cyclophosphamide|Rituximab 375 mg/m^2 on Days -10 and -7; Cyclophosphamide 50 mg/kg on days -3, -2, -1, and 0; Rituximab 375 mg/m^2 weekly x4 after platelet counts recover; For patients achieving at least stable disease, rituximab maintenance 375 mg/m^2 once each during months 3, 6, 9, and 12
1212818|NCT00258206|P1|Participant Flow|Rituximab + Cyclophosphamide|Rituximab 375 mg/m^2 on Days -10 and -7; Cyclophosphamide 50 mg/kg on days -3, -2, -1, and 0; Rituximab 375 mg/m^2 weekly x4 after platelet counts recover; For patients achieving at least stable disease, rituximab maintenance 375 mg/m^2 once each during months 3, 6, 9, and 12
1212819|NCT00258206|O1|Outcome|Rituximab + Cyclophosphamide|Rituximab 375 mg/m^2 on Days -10 and -7; Cyclophosphamide 50 mg/kg on days -3, -2, -1, and 0; Rituximab 375 mg/m^2 weekly x4 after platelet counts recover; For patients achieving at least stable disease, rituximab maintenance 375 mg/m^2 once each during months 3, 6, 9, and 12
1212820|NCT00258206|E1|Reported Event|Rituximab + Cyclophosphamide|Rituximab 375 mg/m^2 on Days -10 and -7; Cyclophosphamide 50 mg/kg on days -3, -2, -1, and 0; Rituximab 375 mg/m^2 weekly x4 after platelet counts recover; For patients achieving at least stable disease, rituximab maintenance 375 mg/m^2 once each during months 3, 6, 9, and 12
1212821|NCT00258154|B3|Baseline|Total|Total of all reporting groups
1212822|NCT00258154|B2|Baseline|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1212823|NCT00258154|B1|Baseline|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212945|NCT00257686|O6|Outcome|Pravastatin 40 mg|Pravastatin 40 mg once daily
1212824|NCT00258154|P2|Participant Flow|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1212825|NCT00258154|P1|Participant Flow|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212826|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1212827|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212828|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1213034|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
1212831|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212832|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1212833|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212834|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1212835|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212836|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1212837|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212838|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1212839|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212840|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1212841|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212842|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1212843|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212844|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1212845|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212846|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1212847|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212848|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1212849|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212850|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1212851|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212852|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1212853|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212854|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1212855|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212856|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1212857|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212858|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1212859|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212860|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1212861|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212862|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1212863|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212864|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1212865|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212866|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1212867|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212868|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1214621|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
1212869|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212870|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1212871|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212872|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1212873|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212874|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1212875|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212876|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1212877|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212878|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1212879|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212880|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1212881|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212882|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1212883|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212884|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1212885|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212886|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1212887|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212888|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1212889|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212890|NCT00258154|E2|Reported Event|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
1212891|NCT00258154|E1|Reported Event|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
1212892|NCT00258011|B1|Baseline|Aldurazyme (Laronidase) Treatment|Patients received weekly infusions of Aldurazyme (laronidase) at an intravenous dose of 100 Units/kg (0.58 mg/kg) body weight (labeled dose) for up to 73 weeks.
1212893|NCT00258011|P1|Participant Flow|Aldurazyme (Laronidase) Treatment|Patients received weekly infusions of Aldurazyme (laronidase) at an intravenous dose of 100 Units/kg (0.58 mg/kg) body weight (labeled dose) for up to 73 weeks.
1212894|NCT00258011|O1|Outcome|Aldurazyme (Laronidase) Treatment|Patients received weekly infusions of Aldurazyme (laronidase) at an intravenous dose of 100 Units/kg (0.58 mg/kg) body weight (labeled dose) for up to 73 weeks.
1212895|NCT00258011|O1|Outcome|Aldurazyme (Laronidase) Treatment|Patients received weekly infusions of Aldurazyme (laronidase) at an intravenous dose of 100 Units/kg (0.58 mg/kg) body weight (labeled dose) for up to 73 weeks.
1212896|NCT00258011|E1|Reported Event|Aldurazyme|Aldurazyme
1212897|NCT00257933|B3|Baseline|Total|Total of all reporting groups
1212898|NCT00257933|B2|Baseline|Lower Dose Prednisolone|Lower dose prednisolone: 1 mg/kg (maximum 30mg)of oral prednisolone every 12 hours alternating with placebo
1212899|NCT00257933|B1|Baseline|High Dose Prednisolone|High dose prednisolone: 1 mg/kg of oral prednisolone (maximum 30mg) every 6 hours
1212900|NCT00257933|P2|Participant Flow|Lower Dose Prednisolone|Lower dose prednisolone: 1 mg/kg (maximum 30mg)of oral prednisolone every 12 hours alternating with placebo
1212901|NCT00257933|P1|Participant Flow|High Dose Prednisolone|High dose prednisolone: 1 mg/kg of oral prednisolone (maximum 30mg) every 6 hours
1212902|NCT00257933|O2|Outcome|Lower Dose Prednisolone|Lower dose prednisolone: 1 mg/kg (maximum 30mg)of oral prednisolone every 12 hours alternating with placebo
1212903|NCT00257933|O1|Outcome|High Dose Prednisolone|High dose prednisolone: 1 mg/kg of oral prednisolone (maximum 30mg) every 6 hours
1212904|NCT00257933|E2|Reported Event|Lower Dose Prednisolone|Lower dose prednisolone: 1 mg/kg (maximum 30mg)of oral prednisolone every 12 hours alternating with placebo
1212905|NCT00257933|E1|Reported Event|High Dose Prednisolone|High dose prednisolone: 1 mg/kg of oral prednisolone (maximum 30mg) every 6 hours
1212906|NCT00257920|B3|Baseline|Total|Total of all reporting groups
1212907|NCT00257920|B2|Baseline|Hectorol First|3.6 mcg Hectorol Injection QOD for 6 doses in Period 1 and 6 mcg Zemplar Injection QOD for 6 doses in Period 2
1212908|NCT00257920|B1|Baseline|Zemplar First|6 mcg Zemplar Injection QOD for 6 doses in Period 1 and 3.6 mcg Hectorol Injection QOD for 6 doses in Period 2
1213515|NCT00255164|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
1212909|NCT00257920|P2|Participant Flow|Hectorol First|3.6 mcg Hectorol Injection QOD for 6 doses in Period 1 and 6 mcg Zemplar Injection QOD for 6 doses in Period 2
1212910|NCT00257920|P1|Participant Flow|Zemplar First|6 mcg Zemplar Injection every other day (QOD) for 6 doses in Period 1 and 3.6 mcg Hectorol Injection for 6 doses in Period 2
1212911|NCT00257920|O2|Outcome|Hectorol|3.6 mcg Hectorol Injection QOD for 6 doses in Period 1 or Period 2
1212912|NCT00257920|O1|Outcome|Zemplar|6 mcg Zemplar Injection QOD for 6 doses in Period 1 or Period 2
1212913|NCT00257920|O2|Outcome|Hectorol|3.6 mcg Hectorol Injection QOD for 6 doses in Period 1 or Period 2.
1212914|NCT00257920|O1|Outcome|Zemplar|6 mcg Zemplar Injection QOD for 6 doses in Period 1 or Period 2
1212915|NCT00257920|E2|Reported Event|Hectorol|3.6 mcg Hectorol Injection QOD for 6 doses in Period 1 or Period 2
1212916|NCT00257920|E1|Reported Event|Zemplar|6mcg Zemplar Injection QOD for 6 doses in Period 1 or Period 2.
1212917|NCT00257894|B3|Baseline|Total|Total of all reporting groups
1212918|NCT00257894|B2|Baseline|Placebo Condition|Placebo capsules identical to active medication, 3/day for 12 days.
1212919|NCT00257894|B1|Baseline|Baclofen Condition|Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
1212920|NCT00257894|P2|Participant Flow|Placebo Condition|Placebo capsules identical to active medication, 3/day for 12 days.
1212921|NCT00257894|P1|Participant Flow|Baclofen Condition|Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
1212922|NCT00257894|O2|Outcome|Placebo Condition|Placebo capsules identical to active medication, 3/day for 12 days.
1212923|NCT00257894|O1|Outcome|Baclofen Condition|Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
1212924|NCT00257894|O2|Outcome|Placebo Condition|Placebo capsules identical to active medication, 3/day for 12 days.
1212925|NCT00257894|O1|Outcome|Baclofen Condition|Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
1212926|NCT00257894|O2|Outcome|Placebo Condition|Placebo capsules identical to active medication, 3/day for 12 days.
1212927|NCT00257894|O1|Outcome|Baclofen Condition|Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
1212928|NCT00257894|O2|Outcome|Placebo Condition|Placebo capsules identical to active medication, 3/day for 12 days.
1212929|NCT00257894|O1|Outcome|Baclofen Condition|Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
1212930|NCT00257894|E2|Reported Event|Placebo Condition|Placebo capsules identical to active medication, 3/day for 12 days.
1212931|NCT00257894|E1|Reported Event|Baclofen Condition|Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
1212932|NCT00257686|B7|Baseline|Total|Total of all reporting groups
1212933|NCT00257686|B6|Baseline|Pravastatin 40 mg|Pravastatin 40 mg once daily
1212934|NCT00257686|B5|Baseline|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
1212935|NCT00257686|B4|Baseline|Pravastatin 20 mg|Pravastatin 20 mg once daily
1212936|NCT00257686|B3|Baseline|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
1212937|NCT00257686|B2|Baseline|Pravastatin 10 mg|Pravastatin 10 mg once daily
1212938|NCT00257686|B1|Baseline|Pitavastatin 1 mg|Pitavastatin 1 mg once daily
1212939|NCT00257686|P6|Participant Flow|Pravastatin 40 mg|Pravastatin 40 mg once daily
1212940|NCT00257686|P5|Participant Flow|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
1212941|NCT00257686|P4|Participant Flow|Pravastatin 20 mg|Pravastatin 20 mg once daily
1212942|NCT00257686|P3|Participant Flow|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
1212943|NCT00257686|P2|Participant Flow|Pravastatin 10 mg|Pravastatin 10 mg once daily
1212951|NCT00257686|O6|Outcome|Pravastatin 40 mg|Pravastatin 40 mg once daily
1212952|NCT00257686|O5|Outcome|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
1212953|NCT00257686|O4|Outcome|Pravastatin 20 mg|Pravastatin 20 mg once daily
1212954|NCT00257686|O3|Outcome|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
1212955|NCT00257686|O2|Outcome|Pravastatin 10 mg|Pravastatin 10 mg once daily
1212956|NCT00257686|O1|Outcome|Pitavastatin 1 mg|Pitavastatin 1 mg once daily
1212957|NCT00257686|E6|Reported Event|Pravastatin 40 mg|Pravastatin 40 mg once daily
1212958|NCT00257686|E5|Reported Event|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
1212959|NCT00257686|E4|Reported Event|Pravastatin 20 mg|Pravastatin 20 mg once daily
1212960|NCT00257686|E3|Reported Event|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
1212961|NCT00257686|E2|Reported Event|Pravastatin 10 mg|Pravastatin 10 mg once daily
1212962|NCT00257686|E1|Reported Event|Pitavastatin 1 mg|Pitavastatin 1 mg once daily
1212963|NCT00257660|B3|Baseline|Total|Total of all reporting groups
1212964|NCT00257660|B2|Baseline|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
1212965|NCT00257660|B1|Baseline|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
1212966|NCT00257660|P2|Participant Flow|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
1212967|NCT00257660|P1|Participant Flow|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
1212968|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
1212969|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
1212970|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
1212971|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
1212972|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
1212973|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
1212974|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
1212975|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
1212976|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
1212977|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
1212978|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
1212979|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
1212980|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
1212981|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
1212982|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
1212983|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
1212984|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
1212985|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
1212986|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
1212987|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
1212988|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
1212989|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
1212990|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
1212991|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
1212992|NCT00257660|E2|Reported Event|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
1212993|NCT00257660|E1|Reported Event|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
1212994|NCT00257608|B3|Baseline|Total|Total of all reporting groups
1212995|NCT00257608|B2|Baseline|Bevacizumab + Erlotinib|Participants received Bevacizumab 15 mg/kg IV on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily
1212996|NCT00257608|B1|Baseline|Bevacizumab + Placebo|Participants received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily
1212997|NCT00257608|P3|Participant Flow|Bevacizumab + Erlotinib|Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.
1212998|NCT00257608|P2|Participant Flow|Bevacizumab + Placebo|Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily.
1212999|NCT00257608|P1|Participant Flow|Bevacizumab + Chemotherapy|Participants received one of six chemotherapy regimens (Carboplatin + Paclitaxel or Carboplatin + Gemcitabine or Carboplatin + Docetaxel or Cisplatin + Gemcitabine or Cisplatin + Docetaxel / Cisplatin + vinorelbine) followed by Bevacizumab on Day 1 of each cycle up to 4 cycles.
1213000|NCT00257608|O2|Outcome|Bevacizumab + Erlotinib|Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.
1213001|NCT00257608|O1|Outcome|Bevacizumab + Placebo|Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily.
1213035|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
1213002|NCT00257608|O2|Outcome|Bevacizumab + Erlotinib|Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.
1213003|NCT00257608|O1|Outcome|Bevacizumab + Placebo|"Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib.~orally daily."
1213004|NCT00257608|O5|Outcome|Other|Included participants who received Cisplatin + Docetaxel or Cisplatin + vinorelbine, participants who received only one of the two chemotherapies planned followed by Bevacizumab of each 21-day cycle up to 4 cycles.
1213005|NCT00257608|O4|Outcome|Cisplatin + Gemcitabine|Participants received IV dose of Cisplatin 80 mg/m^2 on Day 1 of each 21-day cycle and Gemcitabine 1000-1250 mg/m^2 on Day 1 and Day 8 followed by Bevacizumab of each 21-day cycle up to 4 cycles.
1213006|NCT00257608|O3|Outcome|Carboplatin + Docetaxel|Participants received IV dose of Carboplatin at a dose based on the AUC of of 6 mg/mL × min and Docetaxel 75 mg/m^2, respectively followed by Bevacizumab on Day 1 of each 21-day cycle up to 4 cycles.
1213007|NCT00257608|O2|Outcome|Carboplatin + Gemcitabine|Participants received IV dose of Carboplatin at a dose based on the AUC of 5 mg/mL × min on Day 1 of each 21-day cycle and Gemcitabine 1200 mg/m^2 on Day 1 and Day 8 followed by Bevacizumab of each 21-day cycle up to 4 cycles.
1213008|NCT00257608|O1|Outcome|Carboplatin + Paclitaxel|Participants received Intravenous (IV) dose of Carboplatin at a dose based on an area under the concentration time curve (AUC) of 6 milligram /milliliter (mg/mL) × minute (min) and Paclitaxel 200 milligram per square meter (mg/m^2) over 3 hours, respectively followed by Bevacizumab on Day 1 of each 21-day cycle up to 4 cycles.
1213009|NCT00257608|O2|Outcome|Bevacizumab + Erlotinib|Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.
1213010|NCT00257608|O1|Outcome|Bevacizumab + Placebo|Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily.
1213011|NCT00257608|O2|Outcome|Bevacizumab + Erlotinib|Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.
1213012|NCT00257608|O1|Outcome|Bevacizumab + Placebo|Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily.
1213013|NCT00257608|O5|Outcome|Other|Included participants who received Cisplatin + Docetaxel or Cisplatin + vinorelbine, participants who received only one of the two chemotherapies planned followed by Bevacizumab of each 21-day cycle up to 4 cycles.
1213014|NCT00257608|O4|Outcome|Cisplatin + Gemcitabine|Participants received IV dose of Cisplatin 80 mg/m^2 on Day 1 of each 21-day cycle and Gemcitabine 1000-1250 mg/m^2 on Day 1 and Day 8 followed by Bevacizumab of each 21-day cycle up to 4 cycles.
1213015|NCT00257608|O3|Outcome|Carboplatin + Docetaxel|Participants received IV dose of Carboplatin at a dose based on the AUC of of 6 mg/mL × min and Docetaxel 75 mg/m^2, respectively followed by Bevacizumab on Day 1 of each 21-day cycle up to 4 cycles.
1213016|NCT00257608|O2|Outcome|Carboplatin + Gemcitabine|Participants received IV dose of Carboplatin at a dose based on the AUC of 5 mg/mL × min on Day 1 of each 21-day cycle and Gemcitabine 1200 mg/m^2 on Day 1 and Day 8 followed by Bevacizumab of each 21-day cycle up to 4 cycles.
1213017|NCT00257608|O1|Outcome|Carboplatin + Paclitaxel|Participants received Intravenous (IV) dose of Carboplatin at a dose based on an area under the concentration-time curve (AUC) of 6 milligram /milliliter (mg/mL) × minute (min) and Paclitaxel 200 milligram per square meter (mg/m^2) over 3 hours, respectively followed by Bevacizumab on Day 1 of each 21-day cycle up to 4 cycles.
1213018|NCT00257608|O2|Outcome|Bevacizumab + Erlotinib|Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.
1213019|NCT00257608|O1|Outcome|Bevacizumab + Placebo|Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily.
1213020|NCT00257608|E2|Reported Event|Bevacizumab + Erlotinib|Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.
1213021|NCT00257608|E1|Reported Event|Bevacizumab + Placebo|Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily.
1213022|NCT00257556|B3|Baseline|Total|Total of all reporting groups
1213023|NCT00257556|B2|Baseline|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
1213024|NCT00257556|B1|Baseline|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
1213025|NCT00257556|P2|Participant Flow|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
1213026|NCT00257556|P1|Participant Flow|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
1213027|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
1213028|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
1213029|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
1213030|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
1213031|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
1213032|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
1213033|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
1213037|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
1213038|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
1213039|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
1213040|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
1213041|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
1213042|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
1213043|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
1213044|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
1213045|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
1213046|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
1213047|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
1213048|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
1213049|NCT00257556|E2|Reported Event|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
1213050|NCT00257556|E1|Reported Event|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
1213051|NCT00257322|B1|Baseline|Chemo Therapy and GM-CSF|Granulocyte-Macrophage Colony-Stimulating Factor
1213052|NCT00257322|P1|Participant Flow|Chemo Therapy and GM-CSF|Granulocyte-macrophage colony-stimulating factor (GM-CSF) 250ug/m^2 SQ QD with a cap of 500mcg SQ QD
1213053|NCT00257322|O1|Outcome|Chemo Therapy and GM-CSF|Granulocyte-Macrophage Colony-Stimulating Factor
1213054|NCT00257322|O1|Outcome|Chemo Therapy and GM-CSF|Granulocyte-Macrophage Colony-Stimulating Factor
1213055|NCT00257322|E1|Reported Event|Chemo Therapy and GM-CSF|Granulocyte-Macrophage Colony-Stimulating Factor
1213056|NCT00257309|B3|Baseline|Total|Total of all reporting groups
1213057|NCT00257309|B2|Baseline|Primary Angioplasty|"Primary angioplasty~Primary angioplasty"
1213058|NCT00257309|B1|Baseline|Thrombolysis|"Weight adjusted tenecteplase bolus + Unfrationated heparin~Tenecteplase + UFH (+ clopidogrel, since 01/97)"
1213059|NCT00257309|P2|Participant Flow|Primary Angioplasty|"Primary angioplasty~Primary angioplasty"
1213060|NCT00257309|P1|Participant Flow|Thrombolysis|"Weight adjusted tenecteplase bolus + Unfrationated heparin~Tenecteplase + UFH (+ clopidogrel, since 01/97)"
1213061|NCT00257309|O2|Outcome|Primary Angioplasty|"Primary angioplasty~Primary angioplasty"
1213062|NCT00257309|O1|Outcome|Thrombolysis|"Weight adjusted tenecteplase bolus + Unfrationated heparin~Tenecteplase + UFH (+ clopidogrel, since 01/97)"
1213063|NCT00257309|O2|Outcome|Primary Angioplasty|"Primary angioplasty~Primary angioplasty"
1213064|NCT00257309|O1|Outcome|Thrombolysis|"Weight adjusted tenecteplase bolus + Unfrationated heparin~Tenecteplase + UFH (+ clopidogrel, since 01/97)"
1213065|NCT00257309|E2|Reported Event|Primary Angioplasty|"Primary angioplasty~Primary angioplasty"
1213066|NCT00257309|E1|Reported Event|Thrombolysis|"Weight adjusted tenecteplase bolus + Unfrationated heparin~Tenecteplase + UFH (+ clopidogrel, since 01/97)"
1213067|NCT00257192|B3|Baseline|Total|Total of all reporting groups
1213068|NCT00257192|B2|Baseline|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213069|NCT00257192|B1|Baseline|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213153|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
1213322|NCT00256724|E1|Reported Event|Sham ITD|sham Impedance Threshold Device
1213323|NCT00256698|B3|Baseline|Total|Total of all reporting groups
1213070|NCT00257192|P2|Participant Flow|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213071|NCT00257192|P1|Participant Flow|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213072|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213073|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213074|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213075|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213076|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213077|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213078|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213079|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213080|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213081|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213082|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213155|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
1213324|NCT00256698|B2|Baseline|Anastrozole|Anastrozole 1 mg
1213083|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213084|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213085|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213086|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213087|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213088|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213089|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213090|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213091|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213092|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213093|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213094|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213095|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213182|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213498|NCT00255177|O1|Outcome|Placebo|
1213096|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213097|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213098|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213099|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213100|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213101|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213102|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213103|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213104|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213105|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213106|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213107|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213108|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213154|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
1213109|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213110|NCT00257192|E2|Reported Event|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213128|NCT00257010|P1|Participant Flow|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
1213129|NCT00257010|O1|Outcome|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
1213130|NCT00257010|O1|Outcome|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
1213111|NCT00257192|E1|Reported Event|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
1213112|NCT00257166|B3|Baseline|Total|Total of all reporting groups
1213113|NCT00257166|B2|Baseline|Placebo|Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
1213114|NCT00257166|B1|Baseline|Ziprasidone|Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator’s discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
1213115|NCT00257166|P2|Participant Flow|Placebo|Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
1213116|NCT00257166|P1|Participant Flow|Ziprasidone|Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator’s discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
1213117|NCT00257166|O2|Outcome|Placebo|Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
1213118|NCT00257166|O1|Outcome|Ziprasidone|Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator’s discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
1213119|NCT00257166|O2|Outcome|Placebo|Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
1213120|NCT00257166|O1|Outcome|Ziprasidone|Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator’s discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
1213121|NCT00257166|O2|Outcome|Placebo|Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
1213122|NCT00257166|O1|Outcome|Ziprasidone|Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator’s discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
1213123|NCT00257166|O2|Outcome|Placebo|Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
1213124|NCT00257166|O1|Outcome|Ziprasidone|Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator’s discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
1213125|NCT00257166|E2|Reported Event|Placebo|Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
1213126|NCT00257166|E1|Reported Event|Ziprasidone|Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator’s discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
1213127|NCT00257010|B1|Baseline|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
1213335|NCT00256698|O1|Outcome|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
1213131|NCT00257010|O1|Outcome|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
1213132|NCT00257010|O1|Outcome|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
1213133|NCT00257010|O1|Outcome|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
1213134|NCT00257010|O1|Outcome|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
1213135|NCT00257010|E1|Reported Event|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
1213136|NCT00256997|B3|Baseline|Total|Total of all reporting groups
1213137|NCT00256997|B2|Baseline|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
1213138|NCT00256997|B1|Baseline|Risperidone Long-Acting Injection (LAI)|Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
1213139|NCT00256997|P2|Participant Flow|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
1213140|NCT00256997|P1|Participant Flow|Risperidone Long-Acting Injection (LAI)|Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
1213141|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
1213142|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
1213143|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
1213144|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
1213145|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
1213146|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
1213147|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
1213148|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
1213149|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
1213150|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
1213151|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
1213152|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
1213156|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
1213157|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
1213158|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
1213159|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
1213336|NCT00256698|O2|Outcome|Anastrozole|Anastrozole 1 mg
1213337|NCT00256698|O1|Outcome|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
1213160|NCT00256997|O1|Outcome|Risperidone Long-Acting Injection (LAI)|Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
1213161|NCT00256997|E2|Reported Event|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
1213162|NCT00256997|E1|Reported Event|Risperidone Long-Acting Injection (LAI)|Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
1213163|NCT00256984|B1|Baseline|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
1213164|NCT00256984|P1|Participant Flow|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
1213165|NCT00256984|O1|Outcome|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
1213166|NCT00256984|O1|Outcome|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
1213167|NCT00256984|O1|Outcome|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
1213168|NCT00256984|O1|Outcome|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
1213169|NCT00256984|O1|Outcome|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
1213170|NCT00256984|O1|Outcome|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
1213171|NCT00256984|O1|Outcome|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
1213172|NCT00256984|E1|Reported Event|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
1213173|NCT00256750|B4|Baseline|Total|Total of all reporting groups
1213174|NCT00256750|B3|Baseline|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213175|NCT00256750|B2|Baseline|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213176|NCT00256750|B1|Baseline|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213177|NCT00256750|P3|Participant Flow|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213178|NCT00256750|P2|Participant Flow|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213179|NCT00256750|P1|Participant Flow|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213180|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213181|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213183|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213184|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213185|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213186|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213338|NCT00256698|O2|Outcome|Anastrozole|Anastrozole 1 mg
1213187|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213188|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213189|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213190|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213191|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213192|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213193|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213194|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213195|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213196|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213197|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213198|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213199|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213200|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213201|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213202|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213203|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213204|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213205|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213206|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213207|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213208|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213209|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213210|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213211|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213212|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213213|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213214|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213215|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213216|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213217|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213218|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213219|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213220|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213221|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213222|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213223|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213224|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213225|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213226|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213227|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213228|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213229|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213230|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213231|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213232|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213233|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213234|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213317|NCT00256724|O2|Outcome|Active ITD|active impedance threshold device
1213235|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213236|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213237|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213238|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213239|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213240|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213241|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213242|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213243|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213244|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213245|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213246|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213247|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213248|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213249|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213250|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213251|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213252|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213253|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213254|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213255|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213256|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213257|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213258|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213259|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213260|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213318|NCT00256724|O1|Outcome|Sham ITD|sham Impedance Threshold Device
1213319|NCT00256724|O2|Outcome|Active ITD|active impedance threshold device
1213261|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213262|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213263|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213264|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213265|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213266|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213267|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213268|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213269|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213270|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213271|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213272|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213273|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213274|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213275|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213276|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213277|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213278|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213279|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213280|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213281|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213282|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213283|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213284|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213285|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213286|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213320|NCT00256724|O1|Outcome|Sham ITD|sham Impedance Threshold Device
1213321|NCT00256724|E2|Reported Event|Active ITD|active impedance threshold device
1213287|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213288|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213289|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213290|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213291|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213292|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213293|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213294|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213295|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213296|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213297|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213298|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213299|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213300|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213301|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213302|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213303|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213304|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213305|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213306|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213307|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213308|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213309|NCT00256750|E3|Reported Event|Belatacept - MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213310|NCT00256750|E2|Reported Event|Belatacept - LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
1213311|NCT00256750|E1|Reported Event|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
1213312|NCT00256724|B3|Baseline|Total|Total of all reporting groups
1213313|NCT00256724|B2|Baseline|Active ITD|active impedance threshold device
1213314|NCT00256724|B1|Baseline|Sham ITD|sham Impedance Threshold Device
1213315|NCT00256724|P2|Participant Flow|Active ITD|active impedance threshold device
1213316|NCT00256724|P1|Participant Flow|Sham ITD|sham Impedance Threshold Device
1213325|NCT00256698|B1|Baseline|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
1213326|NCT00256698|P2|Participant Flow|Anastrozole|Anastrozole 1 mg
1213327|NCT00256698|P1|Participant Flow|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
1213328|NCT00256698|O2|Outcome|Anastrozole|Anastrozole 1 mg
1213329|NCT00256698|O1|Outcome|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
1213330|NCT00256698|O2|Outcome|Anastrozole|Anastrozole 1 mg
1213331|NCT00256698|O1|Outcome|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
1213332|NCT00256698|O2|Outcome|Anastrozole|Anastrozole 1 mg
1213333|NCT00256698|O1|Outcome|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
1213334|NCT00256698|O2|Outcome|Anastrozole|Anastrozole 1 mg
1213341|NCT00256698|O1|Outcome|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
1213342|NCT00256698|E2|Reported Event|Anastrozole|Anastrozole 1 mg
1213343|NCT00256698|E1|Reported Event|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
1213344|NCT00256295|B1|Baseline|Gemcitabine Plus Oxaliplatin|"Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days.~Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days~Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days"
1213345|NCT00256295|P1|Participant Flow|Gemcitabine Plus Oxaliplatin|"Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days.~Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days~Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days"
1213346|NCT00256295|O1|Outcome|Gemcitabine Plus Oxaliplatin|"Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days.~Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days~Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days"
1213347|NCT00256295|O1|Outcome|Gemcitabine Plus Oxaliplatin|"Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days.~Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days~Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days"
1213348|NCT00256295|O1|Outcome|Gemcitabine Plus Oxaliplatin|"Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days.~Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days~Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days"
1213349|NCT00256295|E1|Reported Event|Gemcitabine Plus Oxaliplatin|"Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days.~Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days~Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days"
1213350|NCT00256243|B1|Baseline|Chemotherapy With GM-CSF|"Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with GM-CSF (day 2-6)~This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour."
1213351|NCT00256243|P1|Participant Flow|Chemotherapy With GM-CSF|"Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (day 2-6)~This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour."
1213352|NCT00256243|O1|Outcome|Chemotherapy With GM-CSF|"Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with GM-CSF (day 2-6)~This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour."
1213353|NCT00256243|O1|Outcome|Chemotherapy With GM-CSF|Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with GM-CSF (day 2-6) This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour.
1213354|NCT00256243|E1|Reported Event|Chemotherapy With GM-CSF|"Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with GM-CSF (day 2-6)~This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour."
1213355|NCT00256204|B5|Baseline|Total|Total of all reporting groups
1213356|NCT00256204|B4|Baseline|2mg Delayed Start|2mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
1213357|NCT00256204|B3|Baseline|2mg Early Start|2mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
1213358|NCT00256204|B2|Baseline|1mg Early Start|1mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
1213359|NCT00256204|B1|Baseline|1mg Delayed Start|1mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
1213360|NCT00256204|P4|Participant Flow|2mg Early Start|2mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
1213361|NCT00256204|P3|Participant Flow|2mg Delayed Start|2mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
1213362|NCT00256204|P2|Participant Flow|1mg Early Start|1mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
1213363|NCT00256204|P1|Participant Flow|1mg Delayed Start|1mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
1213364|NCT00256204|O4|Outcome|2mg Delayed Start|+1mg Delayed Start: see 1st column
1213365|NCT00256204|O3|Outcome|2mg Early Start|2mg early start active treatment arm (72 weeks active)
1213366|NCT00256204|O2|Outcome|1mg Early Start|1mg early start active treatment arm (72 weeks active)
1213367|NCT00256204|O1|Outcome|1mg Delayed Start|+ 2 mg Delayed Start: 36 week combined placebo group.
1213368|NCT00256204|O4|Outcome|2mg Delayed Start|2mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
1213369|NCT00256204|O3|Outcome|2mg Early Start|2mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
1213370|NCT00256204|O2|Outcome|1mg Early Start|1mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
1213371|NCT00256204|O1|Outcome|1mg Delayed Start|1mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
1213372|NCT00256204|E3|Reported Event|2mg Active Treatment|2mg Active & 2mg Delayed. This group includes those patients who received 2mg Rasagiline in both the early start active treatment arm (72 weeks active)and those patients who transitioned to active treatment in the 2mg Delayed start treatment arm (36 weeks active treatment)
1213373|NCT00256204|E2|Reported Event|1mg Active Treatment|1mg Active & 1mg Delayed. This group includes those patients who received 1mg Rasagiline in both the early start active treatment arm (72 weeks active)and those patients who transitioned to active treatment in the 1mg Delayed start treatment arm (36 weeks active treatment)
1213374|NCT00256204|E1|Reported Event|Placebo Combined Group|1mg & 2mg combined placebo group includes those patients in 1mg Delayed start and the 2mg Delayed start arms who received placebo for the first 36 weeks.
1213375|NCT00255970|B3|Baseline|Total|Total of all reporting groups
1213376|NCT00255970|B2|Baseline|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
1213377|NCT00255970|B1|Baseline|Regenafil|Regenafil graft
1213378|NCT00255970|P2|Participant Flow|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
1213379|NCT00255970|P1|Participant Flow|Regenafil|Regenafil graft
1213380|NCT00255970|O2|Outcome|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
1213381|NCT00255970|O1|Outcome|Regenafil|Regenafil graft
1213382|NCT00255970|O2|Outcome|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
1213383|NCT00255970|O1|Outcome|Regenafil|Regenafil graft
1213384|NCT00255970|O2|Outcome|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
1213385|NCT00255970|O1|Outcome|Regenafil|Regenafil graft
1213386|NCT00255970|O2|Outcome|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
1213387|NCT00255970|O1|Outcome|Regenafil|Regenafil graft
1213388|NCT00255970|O2|Outcome|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
1213389|NCT00255970|O1|Outcome|Regenafil|Regenafil graft
1213390|NCT00255970|O2|Outcome|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
1213391|NCT00255970|O1|Outcome|Regenafil|Regenafil graft
1213392|NCT00255970|O2|Outcome|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
1213393|NCT00255970|O1|Outcome|Regenafil|Regenafil graft
1213394|NCT00255970|E2|Reported Event|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
1213395|NCT00255970|E1|Reported Event|Regenafil|Regenafil graft
1213396|NCT00255840|B3|Baseline|Total|Total of all reporting groups
1213397|NCT00255840|B2|Baseline|Antiretroviral Therapy Managed by Primary Health Care Nurse|"First line antiretroviral regimen monitored by HIV-trained primary health care nurse:~Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)~Lamivudine (150mg twice daily) and~Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
1213398|NCT00255840|B1|Baseline|Antiretroviral Therapy Monitored by Medical Officer|"First line antiretroviral regimen monitored by a HIV-trained medical doctor:~Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)~Lamivudine (150mg twice daily) and~Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
1213399|NCT00255840|P2|Participant Flow|Antiretroviral Therapy Managed by Primary Health Care Nurse|"First line antiretroviral regimen monitored by HIV-trained primary health care nurse:~Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)~Lamivudine (150mg twice daily) and~Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
1213400|NCT00255840|P1|Participant Flow|Antiretroviral Therapy Monitored by Medical Officer|"First line antiretroviral regimen monitored by a HIV-trained medical doctor:~Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)~Lamivudine (150mg twice daily) and~Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
1213401|NCT00255840|O2|Outcome|Antiretroviral Therapy Managed by Primary Health Care Nurse|"First line antiretroviral regimen monitored by HIV-trained primary health care nurse:~Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)~Lamivudine (150mg twice daily) and~Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
1213402|NCT00255840|O1|Outcome|Antiretroviral Therapy Monitored by Medical Officer|"First line antiretroviral regimen monitored by a HIV-trained medical doctor:~Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)~Lamivudine (150mg twice daily) and~Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
1213403|NCT00255840|E2|Reported Event|Antiretroviral Therapy Managed by Primary Health Care Nurse|"First line antiretroviral regimen monitored by HIV-trained primary health care nurse:~Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)~Lamivudine (150mg twice daily) and~Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
1213449|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
1213404|NCT00255840|E1|Reported Event|Antiretroviral Therapy Monitored by Medical Officer|"First line antiretroviral regimen monitored by a HIV-trained medical doctor:~Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)~Lamivudine (150mg twice daily) and~Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
1213405|NCT00255723|B3|Baseline|Total|Total of all reporting groups
1213406|NCT00255723|B2|Baseline|Arm B|Augmented ICE x 2 cycles (2 risk factors)
1213407|NCT00255723|B1|Baseline|Arm A|Standard dose ICE x 1 cycle, followed by augmented ICE x 1 cycle (0-1 risk factors)
1213408|NCT00255723|P2|Participant Flow|Arm B|Augmented ICE x 2 cycles (2 risk factors)
1213409|NCT00255723|P1|Participant Flow|Arm A|Standard dose ICE x 1 cycle, followed by augmented ICE x 1 cycle (0-1 risk factors)
1213410|NCT00255723|O2|Outcome|Arm B|Augmented ICE x 2 cycles (2 risk factors)
1213411|NCT00255723|O1|Outcome|Arm A|Standard dose ICE x 1 cycle, followed by augmented ICE x 1 cycle (0-1 risk factors)
1213412|NCT00255723|E2|Reported Event|Arm B|Augmented ICE x 2 cycles (2 risk factors)
1213413|NCT00255723|E1|Reported Event|Arm A|Standard dose ICE x 1 cycle, followed by augmented ICE x 1 cycle (0-1 risk factors)
1213414|NCT00255684|B1|Baseline|Conditioning Therapy Followed by TBI|"Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil~graft-versus-tumor prophylaxis therapy~cyclophosphamide~cyclosporine~fludarabine phosphate~mycophenolate mofetil~umbilical cord blood transplantation~radiation therapy"
1213415|NCT00255684|P1|Participant Flow|Conditioning Therapy Followed by TBI|"Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil~graft-versus-tumor prophylaxis therapy~cyclophosphamide~cyclosporine~fludarabine phosphate~mycophenolate mofetil~umbilical cord blood transplantation~radiation therapy"
1213416|NCT00255684|O1|Outcome|Conditioning Therapy Followed by TBI|"Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil~graft-versus-tumor prophylaxis therapy~cyclophosphamide~cyclosporine~fludarabine phosphate~mycophenolate mofetil~umbilical cord blood transplantation~radiation therapy"
1213417|NCT00255684|O1|Outcome|Conditioning Therapy Followed by TBI|"Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil~graft-versus-tumor prophylaxis therapy~cyclophosphamide~cyclosporine~fludarabine phosphate~mycophenolate mofetil~umbilical cord blood transplantation~radiation therapy"
1213418|NCT00255684|E1|Reported Event|Conditioning Therapy Followed by TBI|"Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil~graft-versus-tumor prophylaxis therapy~cyclophosphamide~cyclosporine~fludarabine phosphate~mycophenolate mofetil~umbilical cord blood transplantation~radiation therapy"
1213419|NCT00255190|B3|Baseline|Total|Total of all reporting groups
1213420|NCT00255190|B2|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
1213421|NCT00255190|B1|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
1213422|NCT00255190|P2|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
1213423|NCT00255190|P1|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
1213424|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
1213425|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
1213426|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
1213427|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
1213428|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
1213429|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
1213430|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
1213431|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
1213432|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
1213433|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
1213434|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
1213435|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
1213436|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
1213437|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
1213499|NCT00255177|E4|Reported Event|VGX-410 300mg Twice Daily|
1213438|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
1213439|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
1213440|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
1213441|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
1213442|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
1213443|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
1213444|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
1213445|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
1213446|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
1213447|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
1213448|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
1213450|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
1213451|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
1213452|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
1213453|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
1213454|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
1213455|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
1213456|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
1213457|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
1213458|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
1213459|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
1213460|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
1213461|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
1213462|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
1213463|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
1213464|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
1213465|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
1213466|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
1213467|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
1213468|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
1213469|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
1213470|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
1213471|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
1213472|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
1213473|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
1213474|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
1213475|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
1213476|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
1213477|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
1213478|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
1213479|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
1213480|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
1213481|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
1213482|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
1213483|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
1213484|NCT00255190|E2|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
1213485|NCT00255190|E1|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
1213486|NCT00255177|B5|Baseline|Total|Total of all reporting groups
1213487|NCT00255177|B4|Baseline|VGX-410 300mg Twice Daily|
1213488|NCT00255177|B3|Baseline|VGX-410 300mg Daily|
1213489|NCT00255177|B2|Baseline|VGX-410 150mg Daily|
1213490|NCT00255177|B1|Baseline|Placebo|
1213491|NCT00255177|P4|Participant Flow|VGX-410 300mg Twice Daily|
1213492|NCT00255177|P3|Participant Flow|VGX-410 300mg Daily|
1213493|NCT00255177|P2|Participant Flow|VGX-410 150mg Daily|
1213494|NCT00255177|P1|Participant Flow|Placebo|
1213495|NCT00255177|O4|Outcome|VGX-410 300mg Twice Daily|
1213496|NCT00255177|O3|Outcome|VGX-410 300mg Daily|
1213497|NCT00255177|O2|Outcome|VGX-410 150mg Daily|
1213504|NCT00255164|B3|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
1213505|NCT00255164|B2|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
1213506|NCT00255164|B1|Baseline|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
1213507|NCT00255164|P3|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
1213508|NCT00255164|P2|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
1213509|NCT00255164|P1|Participant Flow|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
1213510|NCT00255164|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
1213511|NCT00255164|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
1213512|NCT00255164|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
1213513|NCT00255164|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
1213514|NCT00255164|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
1214622|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
1213516|NCT00255164|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
1213517|NCT00255164|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
1213518|NCT00255164|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
1213519|NCT00255164|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
1213520|NCT00255164|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
1213521|NCT00255164|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
1213522|NCT00255164|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
1213523|NCT00255164|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
1213524|NCT00255164|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
1213525|NCT00255164|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
1213526|NCT00255164|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
1213527|NCT00255164|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
1213528|NCT00255164|E3|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
1213529|NCT00255164|E2|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
1213530|NCT00255164|E1|Reported Event|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
1213531|NCT00255151|B4|Baseline|Total|Total of all reporting groups
1213532|NCT00255151|B3|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
1213533|NCT00255151|B2|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
1213534|NCT00255151|B1|Baseline|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
1213535|NCT00255151|P3|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
1213536|NCT00255151|P2|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
1213537|NCT00255151|P1|Participant Flow|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
1213538|NCT00255151|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
1213539|NCT00255151|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
1213540|NCT00255151|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
1213541|NCT00255151|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
1213542|NCT00255151|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
1213543|NCT00255151|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
1213544|NCT00255151|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
1213545|NCT00255151|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
1213546|NCT00255151|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
1213547|NCT00255151|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
1213548|NCT00255151|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
1213549|NCT00255151|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
1213550|NCT00255151|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
1213551|NCT00255151|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
1213552|NCT00255151|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
1213553|NCT00255151|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
1213554|NCT00255151|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
1213555|NCT00255151|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
1213556|NCT00255151|E3|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
1214063|NCT00252733|B1|Baseline|Candesartan|Candesartan cilexetil 32 mg once daily
1213557|NCT00255151|E2|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
1213558|NCT00255151|E1|Reported Event|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
1213559|NCT00255125|B3|Baseline|Total|Total of all reporting groups
1213560|NCT00255125|B2|Baseline|Arm Soy Supplement|"Soy Supplement~Soy Supplement: Soy protein supplement will be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
1213561|NCT00255125|B1|Baseline|Arm Placebo|"Placebo~Placebo: Placebo will consist of a capsule without the soy protein added to be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
1213562|NCT00255125|P2|Participant Flow|Arm Soy Supplement|"Soy Supplement~Soy Supplement: Soy protein supplement will be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
1213563|NCT00255125|P1|Participant Flow|Arm Placebo|"Placebo~Placebo: Placebo will consist of a capsule without the soy protein added to be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
1213564|NCT00255125|O2|Outcome|Arm Soy Supplement|"Soy Supplement~Soy Supplement: Soy protein supplement will be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
1213565|NCT00255125|O1|Outcome|Arm Placebo|"Placebo~Placebo: Placebo will consist of a capsule without the soy protein added to be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
1213566|NCT00255125|E2|Reported Event|Arm Soy Supplement|"Soy Supplement~Soy Supplement: Soy protein supplement will be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
1213567|NCT00255125|E1|Reported Event|Arm Placebo|"Placebo~Placebo: Placebo will consist of a capsule without the soy protein added to be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
1213568|NCT00255086|B3|Baseline|Total|Total of all reporting groups
1213569|NCT00255086|B2|Baseline|Control|10mg Placebo pill
1213570|NCT00255086|B1|Baseline|Memantine|"10mg Memantine~Memantine"
1213571|NCT00255086|P2|Participant Flow|Control|Participants were given Placebo
1213572|NCT00255086|P1|Participant Flow|Memantine|"10mg Memantine~Memantine"
1213573|NCT00255086|O2|Outcome|Control|10mg Placebo pill
1213574|NCT00255086|O1|Outcome|Memantine|"10mg Memantine~Memantine"
1213575|NCT00255086|O2|Outcome|Control|Participants were given Placebo
1213576|NCT00255086|O1|Outcome|Memantine|"10mg Memantine~Memantine"
1213577|NCT00255086|E2|Reported Event|Control|Participants were given matching placebo
1213578|NCT00255086|E1|Reported Event|Memantine|10mg Memantine
1213579|NCT00255047|B5|Baseline|Total|Total of all reporting groups
1213580|NCT00255047|B4|Baseline|Study Group 4: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
1213581|NCT00255047|B3|Baseline|Study Group 3: DTaP-IPV and ActHIB®|Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
1213582|NCT00255047|B2|Baseline|Study Group 2: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
1213583|NCT00255047|B1|Baseline|Study Group 1: DAPTACEL®, IPOL®, and ActHIB®|Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
1213584|NCT00255047|P4|Participant Flow|Study Group 4: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
1213585|NCT00255047|P3|Participant Flow|Study Group 3: DTaP-IPV and ActHIB®|Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
1213586|NCT00255047|P2|Participant Flow|Study Group 2: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
1213587|NCT00255047|P1|Participant Flow|Study Group 1: DAPTACEL®, IPOL®, and ActHIB®|Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
1213588|NCT00255047|O4|Outcome|Study Group 4: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
1213589|NCT00255047|O3|Outcome|Study Group 3: DTaP-IPV and ActHIB®|Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
1213590|NCT00255047|O2|Outcome|Study Group 2: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
1213591|NCT00255047|O1|Outcome|Study Group 1: DAPTACEL®, IPOL®, and ActHIB®|Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
1213592|NCT00255047|O4|Outcome|Study Group 4: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
1213593|NCT00255047|O3|Outcome|Study Group 3: DTaP-IPV and ActHIB®|Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
1213594|NCT00255047|O2|Outcome|Study Group 2: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
1213595|NCT00255047|O1|Outcome|Study Group 1: DAPTACEL®, IPOL®, and ActHIB®|Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
1213596|NCT00255047|O4|Outcome|Study Group 4: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
1213597|NCT00255047|O3|Outcome|Study Group 3: DTaP-IPV and ActHIB®|Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
1214064|NCT00252733|P2|Participant Flow|Placebo|Placebo Comparator
1213598|NCT00255047|O2|Outcome|Study Group 2: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
1213599|NCT00255047|O1|Outcome|Study Group 1: DAPTACEL®, IPOL®, and ActHIB®|Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
1213600|NCT00255047|O4|Outcome|Study Group 4: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
1213601|NCT00255047|O3|Outcome|Study Group 3: DTaP-IPV and ActHIB®|Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
1213602|NCT00255047|O2|Outcome|Study Group 2: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
1213603|NCT00255047|O1|Outcome|Study Group 1: DAPTACEL®, IPOL®, and ActHIB®|Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
1213604|NCT00255047|E4|Reported Event|Study Group 4: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
1213605|NCT00255047|E3|Reported Event|Study Group 3: DTaP-IPV and ActHIB®|Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
1213606|NCT00255047|E2|Reported Event|Study Group 2: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
1214623|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
1213607|NCT00255047|E1|Reported Event|Study Group 1: DAPTACEL®, IPOL®, and ActHIB®|Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
1213608|NCT00255034|B3|Baseline|Total|Total of all reporting groups
1213609|NCT00255034|B2|Baseline|48 Weeks of Therapy|Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks
1213610|NCT00255034|B1|Baseline|24 Weeks of Therapy|Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks
1213611|NCT00255034|P2|Participant Flow|48 Weeks of Therapy|Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks
1213612|NCT00255034|P1|Participant Flow|24 Weeks of Therapy|Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks
1213613|NCT00255034|O2|Outcome|48 Weeks of Therapy|Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks
1213614|NCT00255034|O1|Outcome|24 Weeks of Therapy|Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks
1213615|NCT00255034|E2|Reported Event|48 Weeks of Therapy|
1213616|NCT00255034|E1|Reported Event|24 Weeks of Therapy|
1213617|NCT00255008|B5|Baseline|Total|Total of all reporting groups
1213618|NCT00255008|B4|Baseline|Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w|Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
1213619|NCT00255008|B3|Baseline|Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w|Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 24 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
1213620|NCT00255008|B2|Baseline|Genotype 1 Caucasian PEG-IFN/RIB 48 w|Genotype 1 HCV-infected Caucasian subjects treated for up to 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
1213621|NCT00255008|B1|Baseline|Genotype 1 SEA PEG-IFN/RIB 48 w|Genotype 1 hepatitis C virus (HCV)-infected Southeastern Asian (SEA) subjects treated for up to 48 weeks with PegIntron (peginterferon alfa-2b; PEG-IFN) REDIPEN and REBETOL (ribavirin; RIB) combination therapy
1213622|NCT00255008|P4|Participant Flow|Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w|Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
1213623|NCT00255008|P3|Participant Flow|Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w|Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 24 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
1213624|NCT00255008|P2|Participant Flow|Genotype 1 Caucasian PEG-IFN/RIB 48 w|Genotype 1 HCV-infected Caucasian subjects treated for up to 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
1213625|NCT00255008|P1|Participant Flow|Genotype 1 SEA PEG-IFN/RIB 48 w|Genotype 1 hepatitis C virus (HCV)-infected Southeastern Asian (SEA) subjects treated for up to 48 weeks with PegIntron (peginterferon alfa-2b; PEG-IFN) REDIPEN and REBETOL (ribavirin; RIB) combination therapy
1213626|NCT00255008|O4|Outcome|Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w|Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
1213627|NCT00255008|O3|Outcome|Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w|Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 24 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
1213628|NCT00255008|O2|Outcome|Genotype 1 Caucasian PEG-IFN/RIB 48 w|Genotype 1 HCV-infected Caucasian subjects treated for up to 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
1213629|NCT00255008|O1|Outcome|Genotype 1 SEA PEG-IFN/RIB 48 w|Genotype 1 hepatitis C virus (HCV)-infected Southeastern Asian (SEA) subjects treated for up to 48 weeks with PegIntron (peginterferon alfa-2b; PEG-IFN) REDIPEN and REBETOL (ribavirin; RIB) combination therapy
1213630|NCT00255008|E4|Reported Event|Genotype 6,7,8,9 SEA PEG-IFN/RIB 48w|
1213631|NCT00255008|E3|Reported Event|Genotype 6,7,8,9 SEA PEG-IFN/RIB 24w|
1213632|NCT00255008|E2|Reported Event|Genotype 1 Caucasian PEG-IFN/RIB 48w|
1213633|NCT00255008|E1|Reported Event|Genotype 1 SEA PEG-IFN/RIB 48w|
1213634|NCT00254995|B3|Baseline|Total|Total of all reporting groups
1213635|NCT00254995|B2|Baseline|Control Group|"Each individual receiving Menactra vaccine served as their own control for evaluation of acute (Days 0–30) events (short-term surveillance). For the 6-month (long-term) surveillance, for each person receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a received tetanus and diphtheria toxoids (Td), hepatitis A, hepatitis B, or hepatitis A/hepatitis B combination vaccine during the same month 1 year earlier.~Kaiser Permanente database was used as no study vaccine was provided or administered as part of this study."
1213636|NCT00254995|B1|Baseline|Menactra Vaccine Recipients|"Kaiser Permanente members who received Menactra vaccine during the study period.~Kaiser Permanente database was used as no study vaccine was provided or administered as part of this study."
1214065|NCT00252733|P1|Participant Flow|Candesartan|Candesartan cilexetil 32 mg once daily
1214066|NCT00252733|O2|Outcome|Placebo|Placebo Comparator
1213637|NCT00254995|P2|Participant Flow|Control Group|"Each individual receiving Menactra vaccine served as their own control for evaluation of acute (Days 0–30) events (short-term surveillance). For the 6-month (long-term) surveillance, for each person receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a received tetanus and diphtheria toxoids (Td), hepatitis A, hepatitis B, or hepatitis A/hepatitis B combination vaccine during the same month 1 year earlier.~Kaiser Permanente databases were used; Menactra and control vaccine were administered according to routine clinical practice."
1213638|NCT00254995|P1|Participant Flow|Menactra Vaccine Recipients|"Kaiser Permanente members who received Menactra vaccine during the study period.~Kaiser Permanente databases were used; Menactra vaccine was administered according to routine clinical practice."
1213639|NCT00254995|O2|Outcome|Control Group|The 6-month surveillance: For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
1213640|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.~None administered in this study: N/A in this study"
1213641|NCT00254995|O2|Outcome|Control Group|The 6-month surveillance: For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
1213642|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.~None administered in this study: N/A in this study"
1213643|NCT00254995|O2|Outcome|Control Group|The 6-month surveillance: For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
1213644|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.~None administered in this study: N/A in this study"
1213645|NCT00254995|O2|Outcome|Control Group|For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
1213646|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.~None administered in this study: N/A in this study"
1213647|NCT00254995|O2|Outcome|Control Group|For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
1213648|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.~None administered in this study: N/A in this study"
1213649|NCT00254995|O2|Outcome|Control Group|For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
1213650|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.~None administered in this study: N/A in this study"
1213651|NCT00254995|O2|Outcome|Control Group|Individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0–30) events. Rates of events occurring during Days 0–30 following vaccination were compared to rates of events occurring during Days 31–60 following vaccination.
1213652|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.~None administered in this study: N/A in this study"
1213653|NCT00254995|O2|Outcome|Control Group|For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
1213654|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.~None administered in this study: N/A in this study"
1213655|NCT00254995|O2|Outcome|Control Group|"The individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0–30) events. Rates of events occurring during Days 0–30 following vaccination were compared to rates of events occurring during Days 31–60 following vaccination.~The 6-month surveillance: For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals."
1213656|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.~None administered in this study: N/A in this study"
1213657|NCT00254995|E1|Reported Event|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.~None administered in this study: N/A in this study"
1213658|NCT00254982|B3|Baseline|Total|Total of all reporting groups
1214590|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
1213659|NCT00254982|B2|Baseline|Group II (Low-need)|Adult participants with moderate to severe plaque psoriasis who had undergone pretreatment with no more than one currently available systemic therapy (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
1213660|NCT00254982|B1|Baseline|Group 1 (High-need)|Adult participants with moderate to severe plaque psoriasis who were either not controlled by, or were intolerant to or had contraindications to at least two currently available systemic therapies (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
1213661|NCT00254982|P2|Participant Flow|Group II (Low-need)|Adult participants with moderate to severe plaque psoriasis who had undergone pretreatment with no more than one currently available systemic therapy (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
1213743|NCT00254462|B1|Baseline|Atomoxetine|Recommended dosing once daily, divided dosing at investigator discretion. Maximum dose of 1.8 mg/kg/day.
1214624|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
1213662|NCT00254982|P1|Participant Flow|Group 1 (High-need)|Adult participants with moderate to severe plaque psoriasis who were either not controlled by, or were intolerant to or had contraindications to at least two currently available systemic therapies (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
1213663|NCT00254982|O2|Outcome|Group II (Low-need)|Adult participants with moderate to severe plaque psoriasis who had undergone pretreatment with no more than one currently available systemic therapy (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
1213664|NCT00254982|O1|Outcome|Group 1 (High-need)|Adult participants with moderate to severe plaque psoriasis who were either not controlled by, or were intolerant to or had contraindications to at least two currently available systemic therapies (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
1213665|NCT00254982|E2|Reported Event|Group 2 (Low-need)|
1213666|NCT00254982|E1|Reported Event|Group 1 (High-need)|
1213667|NCT00254592|B1|Baseline|Chemotherapy With GM-CSF|Doxorubicin and Cyclophosphamide (AC) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel
1213668|NCT00254592|P1|Participant Flow|Chemotherapy With GM-CSF|Doxorubicin and Cyclophosphamide (AC) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel
1213669|NCT00254592|O1|Outcome|Chemotherapy With GM-CSF|Doxorubicin and Cyclophosphamide (AC) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel
1213670|NCT00254592|E1|Reported Event|Chemotherapy With GM-CSF|Doxorubicin and Cyclophosphamide (AC) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel
1213671|NCT00254566|B3|Baseline|Total|Total of all reporting groups
1213672|NCT00254566|B2|Baseline|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
1213673|NCT00254566|B1|Baseline|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
1213674|NCT00254566|P2|Participant Flow|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
1213675|NCT00254566|P1|Participant Flow|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
1213676|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
1213677|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
1213678|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
1213679|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
1213680|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
1213681|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
1213682|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
1213683|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
1213684|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
1213685|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
1213686|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
1213687|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
1213688|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
1213689|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
1213690|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
1213691|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
1213692|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
1213693|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
1213694|NCT00254566|E2|Reported Event|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
1213695|NCT00254566|E1|Reported Event|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
1213696|NCT00254540|B3|Baseline|Total|Total of all reporting groups
1213697|NCT00254540|B2|Baseline|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
1213698|NCT00254540|B1|Baseline|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
1213699|NCT00254540|P2|Participant Flow|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
1213700|NCT00254540|P1|Participant Flow|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
1213701|NCT00254540|O1|Outcome|Overall|SU-011248 Capsule:First-line Treatment population plus Pretreated population
1213702|NCT00254540|O1|Outcome|Overall|SU-011248 Capsule:First-line Treatment population plus Pretreated population
1213703|NCT00254540|O1|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
1213704|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
1213705|NCT00254540|O1|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
1213706|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
1213707|NCT00254540|O1|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
1213737|NCT00254501|O2|Outcome|Pharmacists Consults Plus Out-of-pocket Cost Waiver|Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
1213983|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
1213708|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
1213738|NCT00254501|O1|Outcome|Usual Care Plus Out-of-pocket Cost Waiver|Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
1213739|NCT00254501|E2|Reported Event|EMPOWER Group|Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
1213709|NCT00254540|O2|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
1213710|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
1213711|NCT00254540|O2|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
1213712|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
1213713|NCT00254540|O2|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
1213714|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
1213715|NCT00254540|O2|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
1213716|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
1213717|NCT00254540|O2|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
1213718|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
1214038|NCT00252967|B1|Baseline|Placebo|
1213740|NCT00254501|E1|Reported Event|Usual Care Plus Out-of-pocket Cost Waiver|Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
1213741|NCT00254462|B3|Baseline|Total|Total of all reporting groups
1213742|NCT00254462|B2|Baseline|Placebo|Recommended dosing once daily, divided dosing at investigator discretion.
1213719|NCT00254540|O2|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
1213720|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
1213721|NCT00254540|O2|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
1213722|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
1213723|NCT00254540|O2|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
1213724|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
1213725|NCT00254540|E1|Reported Event|Overall|SU-011248 Capsule:First-line Treatment population plus Pretreated population
1213726|NCT00254501|B3|Baseline|Total|Total of all reporting groups
1213727|NCT00254501|B2|Baseline|EMPOWER Group|Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
1213728|NCT00254501|B1|Baseline|Usual Care Plus Out-of-pocket Cost Waiver|Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
1213729|NCT00254501|P2|Participant Flow|EMPOWER Group|Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
1213730|NCT00254501|P1|Participant Flow|Usual Care Plus Out-of-pocket Cost Waiver|Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
1213731|NCT00254501|O2|Outcome|EMPOWER|Patients were scheduled for free counseling with pharmacists including medication, diet, and other self-management items. Patients also received waiver of out-of-pocket expenses for diabetes care.
1213732|NCT00254501|O1|Outcome|Usual Care Plus Out-of-pocket Cost Waiver|Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
1213733|NCT00254501|O2|Outcome|Pharmacists Consults Plus Out-of-pocket Cost Waiver|Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
1213734|NCT00254501|O1|Outcome|Usual Care Plus Out-of-pocket Cost Waiver|Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
1213735|NCT00254501|O2|Outcome|EMPOWER Group|Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
1213736|NCT00254501|O1|Outcome|Usual Care Plus Out-of-pocket Cost Waiver|Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
1213744|NCT00254462|P2|Participant Flow|Placebo|Recommended dosing of once per day, with divided dosing allowed at investigators discretion.
1213745|NCT00254462|P1|Participant Flow|Atomoxetine|Recommended dosing of once per day, with divided dosing allowed at investigators discretion. Maximum dose of 1.8 mg/kg/day.
1213746|NCT00254462|O2|Outcome|Placebo|Recommended dosing once daily, divided dose at investigator discretion.
1213747|NCT00254462|O1|Outcome|Atomoxetine|Recommended dosing once daily, divided dose at investigator discretion. Maximum daily dose of 1.8 mg/kg/day.
1213748|NCT00254462|O2|Outcome|Placebo|Recommended dosing once daily, allowed to give in divided dose at investigator discretion.
1213749|NCT00254462|O1|Outcome|Atomoxetine|Recommended dosing once daily, allowed to give in divided dose at investigator discretion. Maximum dose of 1.8 mg/kg/day.
1213750|NCT00254462|E2|Reported Event|Placebo|Recommended dosing once daily, divided dosing at investigator discretion.
1213751|NCT00254462|E1|Reported Event|Atomoxetine|Recommended dosing once daily, divided dosing at investigator discretion. Maximum dose of 1.8 mg/kg/day.
1213752|NCT00254293|B7|Baseline|Total|Total of all reporting groups
1213753|NCT00254293|B6|Baseline|Placebo|Short term (ST) randomized 12 week period: Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks). Long term extension (LTE) variable dosing period: all placebo participants were rolled over to a variable dose of abatacept SC administered weekly following an IV loading dose of abatacept on Day 85.
1213754|NCT00254293|B5|Baseline|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
1213755|NCT00254293|B4|Baseline|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 4 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
1213756|NCT00254293|B3|Baseline|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 ((IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 3 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
1213757|NCT00254293|B2|Baseline|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
1213758|NCT00254293|B1|Baseline|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
1213759|NCT00254293|P7|Participant Flow|Fixed Dose 125 mg Abatacept|Participants who completed the variable dose long term extension (LTE)period and received variable doses of subcutaneous (SC) abatacept (75, 125, 200 mg SC) were rolled over into the LTE with fixed dose, irrespective of body weight: SC abatacept 125 milligram (mg) in pre-filled syringes, administered Weekly.
1213760|NCT00254293|P6|Participant Flow|Placebo|Short term (ST) randomized 12 week period: Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), by body weight. Long term extension (LTE) variable dosing period: all placebo participants rolled over to a variable dose of abatacept SC (75, 125, 200 mg) administered weekly following an IV loading dose of abatacept on Day 85. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
1213761|NCT00254293|P5|Participant Flow|Group 5: 1000 mg IV/200 mg SC|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo; body weight > 100 kg. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose based on weight as described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
1213980|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
1213762|NCT00254293|P4|Participant Flow|Group 4: 1000mg IV/125 mg SC|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo; Body weight > 100 kg. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose as described in group 1 description, or IV placebo for participants randomized to abatacept in ST period); variable long term for 125 mg SC: body weight <60 to >100 kg) . Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
1213781|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
1213782|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
1214078|NCT00252720|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
1213763|NCT00254293|P3|Participant Flow|Group 3 : 750 mg IV/125 mg SC|Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo (body weight 60-100 kg). Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Variable Long term for 125 mg SC: body weight <60 to >100 kg). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
1213764|NCT00254293|P2|Participant Flow|Group 2: 500 mg IV/125 mg SC|Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo;body weight < 60 kg. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period; loading dose described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Variable Long term for 125 mg SC: body weight <60 to >100 kg. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
1213765|NCT00254293|P1|Participant Flow|Group 1: 500 mg IV/75 mg SC|Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); body weight < 60 kg. Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose (IV abatacept for participants randomized to placebo in ST period, loading dose as described in group 1 description, or IV placebo for participants randomized to abatacept in ST period) on Day 85 (IV abatacept based on their weight at screening; < 60 kg received 500 mg abatacept IV, 60 - 100 kg received 750 mg abatacept IV, > 100 kg received 1000 mg abatacept IV for participants randomized to placebo in ST period)or, IV placebo for participants randomized to abatacept in ST period). At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
1213766|NCT00254293|O6|Outcome|LTE (Variable and Fixed Dosing Abatacept)|Long term extension (LTE) consisted of 2 periods: variable dosing of abatacept combined with DMARDS and fixed dosing abatacept combined with DMARDS. Participants were weighed prior to starting LTE (variable dosing) and dosing was assigned per body weight category. Variable dosing period required an IV loading dose prior to starting SC dosing (if participant had been randomized to placebo in the short term period). Variable dosing: 500 mg IV/75 mg SC and 500 mg IV/125 mg SC in participants less than (<)60 kg body weight; 750 mg IV/125 mg SC in participants between 60 and 100 kg body weight; 1000 mg IV/125 mg SC and 1000 mg IV/200 mg SC in participants greater than (>) 100 kg body weight. Participants were rolled over into a fixed SC dose of 125 mg per week in the fixed dosing period prior to their Year 2 anniversary visit for the study (as early as Day 533).
1213767|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Short term (ST) 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks).
1213768|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
1213769|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Short term (ST) 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
1213770|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Short term (ST) 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
1213771|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Short term (ST) 12 week period: Abatacept as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks)
1213772|NCT00254293|O1|Outcome|SC Abatacept|Overall summary of all participants in the LTE. LTE Period consisted of a variable dose (75 mg, 125 mg, 200 mg abatacept) phase first and at Day 533, a fixed dose phase of 125 mg abatacept SC weekly, irrespective of body weight.
1213773|NCT00254293|O1|Outcome|All Treated Participants|ECG Heart Rate change from screening after treatment were summarized for all participants treated with either abatacept or placebo in the Short Term Period
1213774|NCT00254293|O3|Outcome|200 mg SC Abatacept|200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, or IV placebo for participants randomized to abatacept in ST period); body weight >100kg. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
1213775|NCT00254293|O2|Outcome|125 mg SC Abatacept|125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose as described in group 1 description, or IV placebo for participants randomized to abatacept in ST period). Body weight <60 to >100 kg. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
1213776|NCT00254293|O1|Outcome|75 mg SC Abatacept|variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose (IV abatacept for participants randomized to placebo in ST period, or IV placebo for participants randomized to abatacept in ST period); body weight <60kg. At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
1213777|NCT00254293|O1|Outcome|All Treated Participants|ECG change from screening after treatment were summarized for all participants treated with either abatacept or placebo in the Short Term Period.
1213778|NCT00254293|O6|Outcome|Placebo (by Body Weight Category)|Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
1214039|NCT00252967|P2|Participant Flow|Atorvastatin|
1214040|NCT00252967|P1|Participant Flow|Placebo|
1213779|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 5 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 200 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
1213780|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
1214079|NCT00252720|O2|Outcome|Placebo|Placebo Comparator
1213783|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
1213784|NCT00254293|O6|Outcome|Placebo (by Body Weight Category)|Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
1213785|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 5 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 200 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
1213786|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
1213787|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
1213788|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
1213789|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
1213790|NCT00254293|O6|Outcome|Placebo (by Body Weight Category)|Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
1213791|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 5 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 200 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
1213792|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
1213793|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
1213794|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
1213795|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
1213796|NCT00254293|O6|Outcome|Placebo (by Body Weight Category)|Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
1213797|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 5 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 200 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
1213798|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
1213799|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
1213800|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
1213801|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
1213802|NCT00254293|O6|Outcome|Placebo (by Body Weight Category)|Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
1213803|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Short term (ST) 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks).
1213804|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Short term (ST) 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
1213805|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
1213806|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Short term (ST) 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
1213981|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
1213807|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Short term (ST) 12 week period: Abatacept as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks).
1213808|NCT00254293|O6|Outcome|Placebo (by Body Weight Category)|Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
1213809|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 5 received an IV loading dose of abatacept on Day 1 of 1000 mg followed by abatacept 200 mg SC (once weekly for 12 weeks).
1213810|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 4 received an IV loading dose of abatacept on Day 1 of 1000 mg followed by abatacept 125 mg SC (once weekly for 12 weeks).
1214080|NCT00252720|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
1214081|NCT00252720|O2|Outcome|Placebo|Placebo Comparator
1213811|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Subjects randomized to abatacept in group 3 received an IV loading dose of abatacept on Day 1 of 750 mg followed by abatacept 125 mg SC (once weekly for 12 weeks).
1213812|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 2 received an IV loading dose of abatacept on Day 1 of 500 mg followed by abatacept 125 mg SC (once weekly for 12 weeks).
1213813|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 1 received an IV loading dose of abatacept on Day 1 of 500 mg followed by abatacept 75 mg SC (once weekly for 12 weeks).
1213814|NCT00254293|O6|Outcome|Placebo (by Body Weight Category)|Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
1213815|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 5 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 200 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
1213816|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
1213817|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
1213818|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
1213819|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
1213820|NCT00254293|O3|Outcome|200 mg SC Abatacept (Body Weight > 100 kg)|200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (1000 mg IV abatacept for participants randomized to placebo in ST period, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
1213821|NCT00254293|O2|Outcome|125 mg SC Abatacept (Body Weight <60 to >100 kg)|Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose (IV abatacept for participants randomized to placebo in ST period, or IV placebo for participants randomized to abatacept in ST period) on Day 85 (IV abatacept based on their weight at screening; < 60 kg received 500 mg abatacept IV, 60 - 100 kg received 750 mg abatacept IV, > 100 kg received 1000 mg abatacept IV for participants randomized to placebo in ST period)or, IV placebo for participants randomized to abatacept in ST period). At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
1213822|NCT00254293|O1|Outcome|75 mg SC Abatacept (Body Weight < 60 kg)|Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose (IV abatacept for participants randomized to placebo in ST period, loading dose 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly), or IV placebo for participants randomized to abatacept in ST period) on Day 85 (IV abatacept based on their weight at screening; < 60 kg received 500 mg abatacept IV, 60 - 100 kg received 750 mg abatacept IV, > 100 kg received 1000 mg abatacept IV for participants randomized to placebo in ST period)or, IV placebo for participants randomized to abatacept in ST period). At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
1213823|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
1213824|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 4 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
1213825|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 ((IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 3 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
1213826|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
1213827|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
1213828|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
1213829|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 4 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
1213830|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 ((IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 3 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
1213831|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
1213832|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
1213833|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 5 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 200 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
1213834|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
1213835|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
1213836|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
1213837|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
1213838|NCT00254293|E7|Reported Event|Placebo (ST)|Short term (ST) randomized 12 week period: Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks). Long term extension (LTE) variable dosing period: all placebo participants rolled over to a variable dose of abatacept SC (75, 125, 200 mg) administered weekly following an IV loading dose of abatacept on Day 85. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
1213839|NCT00254293|E6|Reported Event|Abatacept (LT) 125 mg SC|Participants who completed the long term extension (LTE)period and received variable doses of subcutaneous (SC) abatacept (as described in Groups 1 - 5) were rolled over into the LTE with fixed dose: SC abatacept 125 milligram (mg) in pre-filled syringes, administered Weekly.
1213840|NCT00254293|E5|Reported Event|Abatacept 750mg IV/125mg SC|Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
1213841|NCT00254293|E4|Reported Event|Abatacept 500mg IV/75mg SC|Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept based on their weight at screening; < 60 kg received 500 mg abatacept IV, 60 - 100 kg received 750 mg abatacept IV, > 100 kg received 1000 mg abatacept IV for participants randomized to placebo in ST period)or, IV placebo for participants randomized to abatacept in ST period). At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
1213842|NCT00254293|E3|Reported Event|Abatacept 500mg IV/125mg SC|Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period; loading dose described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
1213843|NCT00254293|E2|Reported Event|Abatacept 1000mg IV/200mg SC|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose based on weight as described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
1213900|NCT00253747|P2|Participant Flow|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
1213844|NCT00254293|E1|Reported Event|Abatacept 1000mg IV/125mg SC|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose as described in group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
1213845|NCT00254163|B3|Baseline|Total|Total of all reporting groups
1213846|NCT00254163|B2|Baseline|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
1213847|NCT00254163|B1|Baseline|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
1213848|NCT00254163|P2|Participant Flow|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
1213849|NCT00254163|P1|Participant Flow|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
1213850|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
1213851|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
1213852|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
1213853|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
1213854|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
1213855|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
1213856|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
1213857|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
1213858|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
1213859|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
1213860|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
1213861|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
1213862|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
1213863|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
1213864|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
1213865|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
1213866|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
1213867|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
1213868|NCT00254163|E2|Reported Event|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
1213869|NCT00254163|E1|Reported Event|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
1213870|NCT00254072|B3|Baseline|Total|Total of all reporting groups
1213871|NCT00254072|B2|Baseline|Larger Stapler|4.8 mm Circular Stapler
1213872|NCT00254072|B1|Baseline|Smaller Stapler|3.5 mm Circular Stapler
1213873|NCT00254072|P2|Participant Flow|Larger Stapler|4.8 mm Circular Stapler
1213874|NCT00254072|P1|Participant Flow|Smaller Stapler|3.5 mm Circular Stapler
1213875|NCT00254072|O2|Outcome|Larger Stapler|4.8 mm Circular Stapler
1213876|NCT00254072|O1|Outcome|Smaller Stapler|3.5 mm Circular Stapler
1213877|NCT00254072|E2|Reported Event|Larger Stapler|4.8 mm Circular Stapler
1213878|NCT00254072|E1|Reported Event|Smaller Stapler|3.5 mm Circular Stapler
1213879|NCT00253981|B3|Baseline|Total|Total of all reporting groups
1213880|NCT00253981|B2|Baseline|Control|The control group followed the standard of care for the treatment of shin splints, usually physical therapy and medication.
1213881|NCT00253981|B1|Baseline|Experimental|The experimental group received the monochromatic light infrared energy treatment (MIRE).
1213882|NCT00253981|P2|Participant Flow|Standard of Care|Standard of care was characterized by the use of standard medical treatment to include medication.
1213883|NCT00253981|P1|Participant Flow|Infrared Light Therapy|Intervention: The use of infrared light therapy for the treatment of tibial fracture. The treatment was assigned three times a week for four weeks.
1213884|NCT00253981|O2|Outcome|Standard of Care|Standard of care was characterized by the use of standard medical treatment to include medication.
1213885|NCT00253981|O1|Outcome|Infrared Light Therapy|Intervention: The use of infrared light therapy for the treatment of tibial fracture. The treatment was assigned three times a week for four weeks.
1213886|NCT00253981|E2|Reported Event|Control|The control group followed the standard of care for the treatment of shin splints, usually physical therapy and medication.
1213887|NCT00253981|E1|Reported Event|Experimental|The experimental group received the monochromatic light infrared red energy treatment (MIRE).
1213888|NCT00253890|B3|Baseline|Total|Total of all reporting groups
1213889|NCT00253890|B2|Baseline|Placebo|1-3 at bedtime
1213890|NCT00253890|B1|Baseline|Trazodone|50-150mg at bedtime
1213891|NCT00253890|P2|Participant Flow|Placebo|1-3 capsules at bedtime
1213892|NCT00253890|P1|Participant Flow|Trazodone|50-150mg at bedtime
1213893|NCT00253890|O2|Outcome|Placebo|1-3 capsules at bedtime
1213894|NCT00253890|O1|Outcome|Trazodone|50-150mg at bedtime
1213895|NCT00253890|E2|Reported Event|Placebo|1-3 at bedtime
1213896|NCT00253890|E1|Reported Event|Trazodone|50-150mg at bedtime
1213897|NCT00253747|B3|Baseline|Total|Total of all reporting groups
1213898|NCT00253747|B2|Baseline|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1–11. All participants received transdermal nicotine patches.
1214041|NCT00252967|O2|Outcome|Atorvastatin|
1214042|NCT00252967|O1|Outcome|Placebo|
1213899|NCT00253747|B1|Baseline|Osmotic-Release Methylphenidate (OROS-MPH)|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1–11. All participants received transdermal nicotine patches.
1213952|NCT00253435|B1|Baseline|Poor Risk Patients|Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
1213901|NCT00253747|P1|Participant Flow|Osmotic-Release Methylphenidate (OROS-MPH)|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
1213902|NCT00253747|O2|Outcome|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
1213903|NCT00253747|O1|Outcome|Osmotic-Release Methylphenidate (OROS-MPH)|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
1213904|NCT00253747|O10|Outcome|Methylphenidate (OROS-MPH) - Placebo-Week 9|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
1213905|NCT00253747|O9|Outcome|Release Methylphenidate (OROS-MPH)-Week 9|OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
1213906|NCT00253747|O8|Outcome|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Week 7|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
1213907|NCT00253747|O7|Outcome|Release Methylphenidate (OROS-MPH)-Week 7|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
1213908|NCT00253747|O6|Outcome|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Week 4|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
1213909|NCT00253747|O5|Outcome|Release Methylphenidate (OROS-MPH)-Week 4|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
1213910|NCT00253747|O4|Outcome|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Week 11|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
1213911|NCT00253747|O3|Outcome|Osmotic-Release Methylphenidate (OROS-MPH)-Week 11|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
1213912|NCT00253747|O2|Outcome|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Baseline|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
1213913|NCT00253747|O1|Outcome|Osmotic-Release Methylphenidate (OROS-MPH)-Baseline|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
1213914|NCT00253747|O2|Outcome|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
1213915|NCT00253747|O1|Outcome|Osmotic-Release Methylphenidate (OROS-MPH)|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
1213916|NCT00253747|E2|Reported Event|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1–11. All participants received transdermal nicotine patches.
1213917|NCT00253747|E1|Reported Event|Osmotic-Release Methylphenidate (OROS-MPH)|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1–11. All participants received transdermal nicotine patches.
1213918|NCT00253643|B5|Baseline|Total|Total of all reporting groups
1214043|NCT00252967|O2|Outcome|Atorvastatin|
1214044|NCT00252967|O1|Outcome|Placebo|
1213919|NCT00253643|B4|Baseline|Arm IV (Fish Oil Placebo, Green Tea Placebo)|"Patients receive an oil placebo mimicking fish oil 3/day and another placebo mimicking green tea catechins 2/day~placebo: Given olive oil placebo orally 3 times/day~placebo: Given green tea placebo orally 2 times/day"
1213920|NCT00253643|B3|Baseline|Arm III (Fish Oil, Green Tea Placebo)|"Patients receive oral fish oil 3/day and a placebo mimicking green tea catechins 2/day~fish oil: Given orally 3 times/day~placebo: Given green tea placebo orally 2 times/day"
1213953|NCT00253435|P2|Participant Flow|Good Risk Patients|Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
1214625|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
1213921|NCT00253643|B2|Baseline|Arm II (Fish Oil Placebo, Green Tea Catechin Extract)|"Patients receive an oil placebo 3/day and oral green tea extract 2/day~green tea catechin extract: Given orally 2 times/day~placebo: Given olive oil placebo orally 3 times/day"
1213922|NCT00253643|B1|Baseline|Arm I (Fish Oil, Green Tea Catechin Extract)|"Patients receive oral fish oil 3/day and oral green tea extract 2/day~green tea catechin extract: Given orally 2 times/day~fish oil: Given orally 3 times/day"
1213923|NCT00253643|P4|Participant Flow|Arm IV (Fish Oil Placebo, Green Tea Placebo)|"Patients receive an oil placebo mimicking fish oil 3/day and another placebo mimicking green tea catechins 2/day~placebo: Given olive oil placebo orally 3 times/day~placebo: Given green tea placebo orally 2 times/day~laboratory biomarker analysis: Correlative studies~questionnaire administration: Ancillary studies"
1213924|NCT00253643|P3|Participant Flow|Arm III (Fish Oil, Green Tea Placebo)|"Patients receive oral fish oil 3/day and a placebo mimicking green tea catechins 2/day~fish oil: Given orally 3 times/day~placebo: Given green tea placebo orally 2 times/day~laboratory biomarker analysis: Correlative studies~questionnaire administration: Ancillary studies"
1213925|NCT00253643|P2|Participant Flow|Arm II (Fish Oil Placebo, Green Tea Catechin Extract)|"Patients receive an oil placebo 3/day and oral green tea extract 2/day~green tea catechin extract: Given orally 2 times/day~placebo: Given olive oil placebo orally 3 times/day~laboratory biomarker analysis: Correlative studies~questionnaire administration: Ancillary studies"
1213926|NCT00253643|P1|Participant Flow|Arm I (Fish Oil, Green Tea Catechin Extract)|"Patients receive oral fish oil 3/day and oral green tea extract 2/day~green tea catechin extract: Given orally 2 times/day~fish oil: Given orally 3 times/day~laboratory biomarker analysis: Correlative studies~questionnaire administration: Ancillary studies"
1213927|NCT00253643|O4|Outcome|Arm IV|Fish oil placebo, Green Tea placebo
1213928|NCT00253643|O3|Outcome|Arm III|Fish oil, Green Tea placebo
1213929|NCT00253643|O2|Outcome|Arm II|Fish oil placebo, Green Tea catechin extract
1213930|NCT00253643|O1|Outcome|Arm I|Fish oil, Green Tea catechin extract
1213931|NCT00253643|O4|Outcome|Arm IV|Fish oil placebo, Green Tea placebo
1213932|NCT00253643|O3|Outcome|Arm III|Fish oil, Green Tea placebo
1213933|NCT00253643|O2|Outcome|Arm II|Fish oil placebo, Green Tea catechin extract
1213934|NCT00253643|O1|Outcome|Arm I|Fish oil, Green Tea catechin extract
1213935|NCT00253643|E4|Reported Event|Arm IV (Fish Oil Placebo, Green Tea Placebo)|"Patients receive an oil placebo mimicking fish oil 3/day and another placebo mimicking green tea catechins 2/day~placebo: Given olive oil placebo orally 3 times/day~placebo: Given green tea placebo orally 2 times/day"
1213936|NCT00253643|E3|Reported Event|Arm III (Fish Oil, Green Tea Placebo)|"Patients receive oral fish oil 3/day and a placebo mimicking green tea catechins 2/day~fish oil: Given orally 3 times/day~placebo: Given green tea placebo orally 2 times/day"
1213937|NCT00253643|E2|Reported Event|Arm II (Fish Oil Placebo, Green Tea Catechin Extract)|"Patients receive an oil placebo 3/day and oral green tea extract 2/day~green tea catechin extract: Given orally 2 times/day~placebo: Given olive oil placebo orally 3 times/day"
1213938|NCT00253643|E1|Reported Event|Arm I (Fish Oil, Green Tea Catechin Extract)|"Patients receive oral fish oil 3/day and oral green tea extract 2/day~green tea catechin extract: Given orally 2 times/day~fish oil: Given orally 3 times/day"
1213939|NCT00253513|B1|Baseline|Treosulfan and Fludarabine Conditioning|Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
1213940|NCT00253513|P1|Participant Flow|Treosulfan and Fludarabine Conditioning|Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
1213941|NCT00253513|O1|Outcome|Treosulfan and Fludarabine Conditioning|Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
1213942|NCT00253513|O1|Outcome|Treosulfan and Fludarabine Conditioning|Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
1213943|NCT00253513|O1|Outcome|Treosulfan and Fludarabine Conditioning|Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
1213944|NCT00253513|O1|Outcome|Treosulfan and Fludarabine Conditioning|Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
1213945|NCT00253513|E1|Reported Event|Treosulfan and Fludarabine Conditioning|Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
1213946|NCT00253448|B1|Baseline|Stereotactic Radiosurgery Plus Conventional Radiotherapy|Single 15-24 Gy Gamma Knife radiosurgical treatment to MR-Spectroscopy active region followed by 60 Gy of conventionally fractionated radiotherapy (2.0 Gy will be given daily 5 days per week for a total of 60.0 Gy)
1213947|NCT00253448|P1|Participant Flow|Stereotactic Radiosurgery Plus Conventional Radiotherapy|Single 15-24 Gy Gamma Knife radiosurgical treatment to MR-Spectroscopy active region followed by 60 Gy of conventionally fractionated radiotherapy (2.0 Gy will be given daily 5 days per week for a total of 60.0 Gy)
1213948|NCT00253448|O1|Outcome|Stereotactic Radiosurgery Plus Conventional Radiotherapy|Single 15-24 Gy Gamma Knife radiosurgical treatment to MR-Spectroscopy active region followed by 60 Gy of conventionally fractionated radiotherapy (2.0 Gy will be given daily 5 days per week for a total of 60.0 Gy)
1213982|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
1213949|NCT00253448|E1|Reported Event|Stereotactic Radiosurgery Plus Conventional Radiotherapy|Single 15-24 Gy Gamma Knife radiosurgical treatment to MR-Spectroscopy active region followed by 60 Gy of conventionally fractionated radiotherapy (2.0 Gy will be given daily 5 days per week for a total of 60.0 Gy)
1213950|NCT00253435|B3|Baseline|Total|Total of all reporting groups
1213951|NCT00253435|B2|Baseline|Good Risk Patients|Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
1213954|NCT00253435|P1|Participant Flow|Poor Risk Patients|Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
1213955|NCT00253435|O2|Outcome|Good Risk Patients|Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
1213956|NCT00253435|O1|Outcome|Poor Risk Patients|Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
1213957|NCT00253435|O2|Outcome|Good Risk Patients|Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
1213958|NCT00253435|O1|Outcome|Poor Risk Patients|Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
1213959|NCT00253435|O2|Outcome|Good Risk Patients|Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
1213960|NCT00253435|O1|Outcome|Poor Risk Patients|Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
1213961|NCT00253435|O2|Outcome|Good Risk Patients|Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
1213962|NCT00253435|O1|Outcome|Poor Risk Patients|Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
1213963|NCT00253435|E2|Reported Event|Good Risk Patients|Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
1213964|NCT00253435|E1|Reported Event|Poor Risk Patients|Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
1213965|NCT00253370|B1|Baseline|BAY 43-9006, Docetaxel, Cisplatin|"Patients receive oral BAY 43-9006 twice daily on days 1-21. Patients also receive docetaxel IV over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~BAY 43-9006: Given orally~docetaxel: Given IV~cisplatin: Given IV"
1213966|NCT00253370|P1|Participant Flow|BAY 43-9006, Docetaxel, Cisplatin|"Patients receive oral BAY 43-9006 400 mg twice daily on days 1-21. Patients also receive docetaxel IV, 75mg/m2 over 1 hour and cisplatin IV, 75 mg/m2 over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~BAY 43-9006: Given orally~docetaxel: Given IV~cisplatin: Given IV"
1213967|NCT00253370|O1|Outcome|BAY 43-9006, Docetaxel, Cisplatin|"Patients receive oral BAY 43-9006 twice daily on days 1-21. Patients also receive docetaxel IV, 75 mg/m2 over 1 hour and cisplatin IV, 75 mg/m2 over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~BAY 43-9006: Given orally~docetaxel: Given IV~cisplatin: Given IV"
1213968|NCT00253370|O1|Outcome|BAY 43-9006, Docetaxel, Cisplatin|"Patients receive oral BAY 43-9006 twice daily on days 1-21. Patients also receive docetaxel IV, 75 mg/m2over 1 hour and cisplatin IV, 75 mg/m2 over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~BAY 43-9006: Given orally~docetaxel: Given IV~cisplatin: Given IV"
1213969|NCT00253370|O1|Outcome|BAY 43-9006, Docetaxel, Cisplatin|"Patients receive oral BAY 43-9006 twice daily on days 1-21. Patients also receive docetaxel IV, 75 mg/m2 over 1 hour and cisplatin IV, 75 mg/m2 over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~BAY 43-9006: Given orally~docetaxel: Given IV~cisplatin: Given IV"
1213970|NCT00253370|E1|Reported Event|BAY 43-9006, Docetaxel, Cisplatin|"Patients receive oral BAY 43-9006 twice daily on days 1-21. Patients also receive docetaxel IV over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~BAY 43-9006: Given orally~docetaxel: Given IV~cisplatin: Given IV"
1213971|NCT00251927|B3|Baseline|Total|Total of all reporting groups
1213972|NCT00251927|B2|Baseline|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
1213973|NCT00251927|B1|Baseline|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
1213974|NCT00251927|P2|Participant Flow|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
1213975|NCT00251927|P1|Participant Flow|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
1213976|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
1213977|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
1213978|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
1213979|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
1213984|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
1213985|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
1213986|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
1213987|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
1214076|NCT00252720|P1|Participant Flow|Candesartan|Candesartan cilexetil 32 mg once daily
1213988|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
1213989|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
1213990|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
1213991|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
1213992|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
1213993|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
1213994|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
1213995|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
1213996|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
1213997|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
1213998|NCT00251927|E3|Reported Event|Non-Surgical Arm|This group of patients was randomized to receive surgery but were on operated on and were followed for safety purposes
1213999|NCT00251927|E2|Reported Event|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
1214000|NCT00251927|E1|Reported Event|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
1214001|NCT00251862|B4|Baseline|Total|Total of all reporting groups
1214002|NCT00251862|B3|Baseline|Control|Standard Care
1214003|NCT00251862|B2|Baseline|DA Alone|Decision aid alone
1214004|NCT00251862|B1|Baseline|DA + YDR|Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback
1214005|NCT00251862|P3|Participant Flow|Control|Standard Care
1214006|NCT00251862|P2|Participant Flow|DA Alone|Decision aid alone
1214007|NCT00251862|P1|Participant Flow|DA + YDR|Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback
1214008|NCT00251862|O3|Outcome|Control|Standard Care
1214009|NCT00251862|O2|Outcome|DA Alone|Decision aid alone
1214010|NCT00251862|O1|Outcome|DA + YDR|Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback
1214011|NCT00251862|O3|Outcome|Control|Standard Care
1214012|NCT00251862|O2|Outcome|DA Alone|Decision aid alone
1214013|NCT00251862|O1|Outcome|DA + YDR|Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback
1214014|NCT00251862|O3|Outcome|Control|Standard Care
1214015|NCT00251862|O2|Outcome|DA Alone|Decision aid alone
1214016|NCT00251862|O1|Outcome|DA + YDR|Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback
1214017|NCT00251862|O3|Outcome|Control|Standard Care
1214018|NCT00251862|O2|Outcome|DA Alone|Decision aid alone
1214019|NCT00251862|O1|Outcome|DA + YDR|Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback
1214020|NCT00251862|E3|Reported Event|Control|Standard Care
1214021|NCT00251862|E2|Reported Event|DA Alone|Decision aid alone
1214022|NCT00251862|E1|Reported Event|DA + YDR|Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback
1214023|NCT00253019|B4|Baseline|Total|Total of all reporting groups
1214024|NCT00253019|B3|Baseline|Ortho Evra|Participants self-selected to receive Ortho Evra.
1214025|NCT00253019|B2|Baseline|Depo Provera|Participants self-selected to receive Depo Provera
1214026|NCT00253019|B1|Baseline|Oral Contraceptive|Participants self-selected to receive oral contraceptives.
1214027|NCT00253019|P3|Participant Flow|Ortho Evra|Participants self-selected to receive Ortho Evra.
1214028|NCT00253019|P2|Participant Flow|Depo Provera|Participants self-selected to receive Depo Provera
1214029|NCT00253019|P1|Participant Flow|Oral Contraceptive|Participants self-selected to receive oral contraceptives.
1214030|NCT00253019|O3|Outcome|Ortho Evra|Participants self-selected to receive Ortho Evra.
1214031|NCT00253019|O2|Outcome|Depo Provera|Participants self-selected to receive Depo Provera
1214032|NCT00253019|O1|Outcome|Oral Contraceptive|Participants self-selected to receive oral contraceptives.
1214033|NCT00253019|E3|Reported Event|Ortho Evra|participants self-selected to receive ortho evra
1214034|NCT00253019|E2|Reported Event|Depo Provera|Participants self-selected to use depo provera
1214035|NCT00253019|E1|Reported Event|Oral Contraceptives|participants self-selected to take oral contraceptives
1214036|NCT00252967|B3|Baseline|Total|Total of all reporting groups
1214037|NCT00252967|B2|Baseline|Atorvastatin|
1214067|NCT00252733|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
1214068|NCT00252733|O2|Outcome|Placebo|Placebo Comparator
1214069|NCT00252733|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
1214070|NCT00252733|E2|Reported Event|Placebo|Placebo Comparator
1214071|NCT00252733|E1|Reported Event|Candesartan|Candesartan cilexetil 32 mg once daily
1214072|NCT00252720|B3|Baseline|Total|Total of all reporting groups
1214073|NCT00252720|B2|Baseline|Placebo|Placebo Comparator
1214074|NCT00252720|B1|Baseline|Candesartan|Candesartan cilexetil 32 mg once daily
1214075|NCT00252720|P2|Participant Flow|Placebo|Placebo Comparator
1214082|NCT00252720|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
1214083|NCT00252720|O2|Outcome|Placebo|Placebo Comparator
1214084|NCT00252720|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
1214085|NCT00252720|E2|Reported Event|Placebo|Placebo Comparator
1214086|NCT00252720|E1|Reported Event|Candesartan|Candesartan cilexetil 32 mg once daily
1214087|NCT00252694|B3|Baseline|Total|Total of all reporting groups
1214088|NCT00252694|B2|Baseline|Placebo|Placebo Comparator
1214089|NCT00252694|B1|Baseline|Candesartan|Candesartan cilexetil 32 mg once daily
1214090|NCT00252694|P2|Participant Flow|Placebo|Placebo Comparator
1214091|NCT00252694|P1|Participant Flow|Candesartan|Candesartan cilexetil 32 mg once daily
1214092|NCT00252694|O2|Outcome|Placebo|Placebo Comparator
1214093|NCT00252694|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
1214094|NCT00252694|O2|Outcome|Placebo|Placebo Comparator
1214095|NCT00252694|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
1214096|NCT00252694|O2|Outcome|Placebo|Placebo Comparator
1214097|NCT00252694|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
1214098|NCT00252694|O2|Outcome|Placebo|Placebo Comparator
1214099|NCT00252694|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
1214100|NCT00252694|E2|Reported Event|Placebo|Placebo Comparator
1214101|NCT00252694|E1|Reported Event|Candesartan|Candesartan cilexetil 32 mg once daily
1214102|NCT00252629|B4|Baseline|Total|Total of all reporting groups
1214103|NCT00252629|B3|Baseline|Healthy Asymptomatic Control|"Eleven male veterans of first gulf war were screened for fatigue, pain and cognitive dysfunction by self report instrument.~They all score below the clinical thershold and assigned as healthy asymptomatic"
1214104|NCT00252629|B2|Baseline|Sham Nasal CPAP|The occurrence of the following 3 symptoms in a Gulf War veteran beginning after 8/90, lasting at least 6 months and present at the time of screening: fatigue that limits usual activity; musculoskeletal pain involving 2 or more regions of the body; and cognitive symptoms (memory, concentration, or attention difficulties). All 3 symptoms must be unexplained by any clearly defined organic illness.
1214105|NCT00252629|B1|Baseline|Therapeutic Nasal CPAP|The occurrence of the following 3 symptoms in a Gulf War veteran beginning after 8/90, lasting at least 6 months and present at the time of screening: fatigue that limits usual activity; musculoskeletal pain involving 2 or more regions of the body; and cognitive symptoms (memory, concentration, or attention difficulties). All 3 symptoms must be unexplained by any clearly defined organic illness.
1214106|NCT00252629|P3|Participant Flow|Comparison of IFL During Sleep in GWS and Healthy|"We recruited 18 male veterans with GWS (same group that were randomized to receive CPAP treatment) and 11 asymptomatic male veterans of the first Gulf war.~All veterans had a polysomnography to determine the presence of sleep disordered breathing.~We compared the prevalence of Inspiratory Flow Limitation (IFL) during supine stage 2 sleep among both groups."
1214107|NCT00252629|P2|Participant Flow|Sham Nasal CPAP|"Nine participants assigned to receive 3 weeks of treatment during sleep with sham nasal CPAP.~Using validated questionnaires, fatigue, pain, and cognitive dysfunction were assessed by self-report before and after the three weeks treatment trial.~We compared the change of veterans reported outcomes symptoms change before and after 3 weeks treatment period on sham nasal CPAP."
1214108|NCT00252629|P1|Participant Flow|Therapeutic Nasal CPAP|"Nine participants assigned to receive 3 weeks of treatment during sleep with therapeutic nasal CPAP.~Using validated questionnaires, fatigue, pain, and cognitive dysfunction were assessed by self-report before and after the three weeks treatment trial.~We compared the change of veterans reported outcomes symptoms change before and after 3 weeks treatment period on therapeutic nasal CPAP."
1214109|NCT00252629|O2|Outcome|Asymptomatic Male Veterans of Gulf War.|"A group of 11 asymptomatic male veterans of gulf war were examined. Each participant underwent full night polysomnogram while sleeping supine using a standard clinical monitoring for sleep and breathing. Inspiratory flow was measured using pneumotachograph and respiratory effort measured with supra-glottis catheter.~Sampling of flow and effort during continuous stage 2 sleep was obtained and compared among both groups.~Inspiratory flow was plotted against effort for each breath. IFL was defined as a 1 cm H2O or greater decrease in supraglotic pressure without a corresponding increase in airflow of at least 5 ml/second.~The percentage of flow limited breath was calculated as the total number of flow limited breaths divided by the total breaths in all the samples."
1214110|NCT00252629|O1|Outcome|GWS Male Group|"A group of18 male veterans with GWS were examined. Each participant underwent full night polysomnogram while sleeping supine using a standard clinical monitoring for sleep and breathing. Inspiratory flow was measured using pneumotachograph and respiratory effort measured with supra-glottis catheter.~Sampling of flow and effort during continuous stage 2 sleep was obtained and compared among both groups.~Inspiratory flow was plotted against effort for each breath. IFL was defined as a 1 cm H2O or greater decrease in supraglotic pressure without a corresponding increase in airflow of at least 5 ml/second.~The percentage of flow limited breath was calculated as the total number of flow limited breaths divided by the total breaths in all the samples."
1214293|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
1214111|NCT00252629|O2|Outcome|Sham Nasal CPAP|Comparing the change of cognitive dysfunction ( increasing difficulty with memory, ability to think, and ability to concentrate) complaints before and after 3 weeks treatment on sham nasal CPAP
1214112|NCT00252629|O1|Outcome|Therapeutic Nasal CPAP|Comparing the change of cognitive dysfunction ( increasing difficulty with memory, ability to think, and ability to concentrate) complaints before and after 3 weeks treatment of therapeutic nasal CPAP
1214113|NCT00252629|O2|Outcome|Sham Nasal CPAP|Comparing the change of pain complaint before and after treatment of 3 weeks on sham nasal CPAP
1214114|NCT00252629|O1|Outcome|Therapeutic Nasal CPAP|Comparing the change of pain complaint before and after 3 weeks treatment of therapeutic nasal CPAP
1214115|NCT00252629|O2|Outcome|Sham Nasal CPAP|Comparing the change of fatigue complaint before and after treatment of 3 weeks on sham nasal CPAP
1214116|NCT00252629|O1|Outcome|Therapeutic Nasal CPAP|Comparing the change of fatigue complaint before and after 3 weeks treatment of therapeutic nasal CPAP
1214210|NCT00252239|E1|Reported Event|TNK 0.1 mg/kg|Lowest dose tenecteplase
1214211|NCT00252187|B3|Baseline|Total|Total of all reporting groups
1214117|NCT00252629|E3|Reported Event|Comparison of IFL During Sleep in GWS and Healthy|"We recruited 11 asymptomatic male veterans of the first Gulf war. In addition to our 18 male veterans with GWS (same group that were randomized to receive CPAP treatment).~All veterans had a polysomnography to determine the presence of sleep disordered breathing.~We compared the prevalence of Inspiratory Flow Limitation (IFL) during supine stage 2 sleep among both groups."
1214118|NCT00252629|E2|Reported Event|Sham Nasal CPAP|Comparing change of veterans reported outcomes ( fatigue, pain and cognitive dysfunction) before and after 3 weeks treatment on sham nasal CPAP with change of symptoms on therapeutic nasal CPAP
1214119|NCT00252629|E1|Reported Event|Therapeutic Nasal CPAP|Comparing change of veterans reported outcomes ( fatigue, pain and cognitive dysfunction) before and after 3 weeks treatment on therapeutic nasal CPAP with change of symptoms on sham nasal CPAP
1214120|NCT00252590|B4|Baseline|Total|Total of all reporting groups
1214121|NCT00252590|B3|Baseline|Control - Treatment as Usual|"No added treatment control~Control - treatment as usual: Control group with no additional intervention"
1214122|NCT00252590|B2|Baseline|Health Education|"Non-personalized didactic health-related education~Health Education: Generalized health education related to alcohol use"
1214123|NCT00252590|B1|Baseline|Health Motivational Feedback|"Personalized health-related feedback~Health Motivational Feedback: Personalized feedback on health status"
1214124|NCT00252590|P3|Participant Flow|Control - Treatment as Usual|"No added treatment control~Control - treatment as usual: Control group with no additional intervention"
1214125|NCT00252590|P2|Participant Flow|Health Education|"Non-personalized didactic health-related education~Health Education: Generalized health education related to alcohol use provided in four once monthly 45-minute sessions. Topics for sessions include sleep, pain, cardiovascular health, and gastrointestinal health."
1214126|NCT00252590|P1|Participant Flow|Health Motivational Feedback|"Personalized health-related feedback~Health Motivational Feedback: Personalized feedback on health status provided in four once monthly 45 minute sessions. Information for feedback was attained with assessments and blood serum testing."
1214127|NCT00252590|O3|Outcome|Control - Treatment as Usual|"No added treatment control~Control - treatment as usual: Control group with no additional intervention"
1214128|NCT00252590|O2|Outcome|Health Education|"Non-personalized didactic health-related education~Health Education: Generalized health education related to alcohol use"
1214129|NCT00252590|O1|Outcome|Health Motivational Feedback|"Personalized health-related feedback~Health Motivational Feedback: Personalized feedback on health status"
1214130|NCT00252590|O3|Outcome|Control - Treatment as Usual|"No added treatment control~Control - treatment as usual: Control group with no additional intervention"
1214131|NCT00252590|O2|Outcome|Health Education|"Non-personalized didactic health-related education~Health Education: Generalized health education related to alcohol use"
1214132|NCT00252590|O1|Outcome|Health Motivational Feedback|"Personalized health-related feedback~Health Motivational Feedback: Personalized feedback on health status"
1214133|NCT00252590|E3|Reported Event|Control - Treatment as Usual|"No added treatment control~Control - treatment as usual: Control group with no additional intervention"
1214134|NCT00252590|E2|Reported Event|Health Education|"Non-personalized didactic health-related education~Health Education: Generalized health education related to alcohol use"
1214135|NCT00252590|E1|Reported Event|Health Motivational Feedback|"Personalized health-related feedback~Health Motivational Feedback: Personalized feedback on health status"
1214136|NCT00252564|B3|Baseline|Total|Total of all reporting groups
1214137|NCT00252564|B2|Baseline|Arm B|"(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.~Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU"
1214138|NCT00252564|B1|Baseline|Arm A|"(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via “T” connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.~Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU~Dosing on Days 1 and 15 of each 28-day cycle"
1214139|NCT00252564|P2|Participant Flow|Arm B|"(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.~Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU"
1214140|NCT00252564|P1|Participant Flow|Arm A|"(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via “T” connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.~Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU~Dosing on Days 1 and 15 of each 28-day cycle"
1214141|NCT00252564|O2|Outcome|Arm B|"(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.~Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU"
1214142|NCT00252564|O1|Outcome|Arm A|"(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via “T” connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.~Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU~Dosing on Days 1 and 15 of each 28-day cycle"
1214294|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
1214143|NCT00252564|O2|Outcome|Arm B|"(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.~Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU"
1214144|NCT00252564|O1|Outcome|Arm A|"(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via “T” connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.~Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU~Dosing on Days 1 and 15 of each 28-day cycle"
1214145|NCT00252564|O2|Outcome|Arm B|"(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.~Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU"
1214212|NCT00252187|B2|Baseline|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
1214626|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
1214146|NCT00252564|O1|Outcome|Arm A|"(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via “T” connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.~Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU~Dosing on Days 1 and 15 of each 28-day cycle"
1214147|NCT00252564|O2|Outcome|Arm B|"(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.~Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU"
1214148|NCT00252564|O1|Outcome|Arm A|"(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via “T” connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.~Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU~Dosing on Days 1 and 15 of each 28-day cycle"
1214149|NCT00252564|E2|Reported Event|Arm B|"(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.~Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU"
1214150|NCT00252564|E1|Reported Event|Arm A|"(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via “T” connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.~Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU~Dosing on Days 1 and 15 of each 28-day cycle"
1214151|NCT00252538|B1|Baseline|Group 1|"Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus, 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months~interferon-alpha: This is an observational study only. The patients are on interferon alpha therapy for HCV, but prescribing interferon is not a part of this research study protocol."
1214152|NCT00252538|P2|Participant Flow|Group 2 Non MDD|"Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus (HCV), 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months~This is an observational study that segregates patients who have HCV and are started on interferon alpha treatment into 2 groups based on whether they develop major depressive disorder (MDD) while on interferon alpha therapy for HCV and then examines genes that may confer risk for MDD development. group 1 MDD and group 2 no MDD"
1214153|NCT00252538|P1|Participant Flow|Group 1 MDD|"Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus (HCV), 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months~This is an observational study that segregates patients who have HCV and are started on interferon alpha treatment into 2 groups based on whether they develop major depressive disorder (MDD) while on interferon alpha therapy for HCV and then examines genes that may confer risk for MDD development. group 1 MDD and group 2 no MDD"
1214154|NCT00252538|O2|Outcome|Group 2- no MDD|"Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus, 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months~This is an observational study that segregates patients who have HCV and are started on interferon alpha treatment into 2 groups based on whether they develop major depressive disorder (MDD) while on interferon alpha therapy for HCV and then examines genes that may confer risk for MDD development. group 1 MDD and group 2 no MDD"
1214155|NCT00252538|O1|Outcome|Group 1- MDD|"Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus, 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months~This is an observational study that segregates patients who have HCV and are started on interferon alpha treatment into 2 groups based on whether they develop major depressive disorder (MDD) while on interferon alpha therapy for HCV and then examines genes that may confer risk for MDD development. group 1 MDD and group 2 no MDD"
1214156|NCT00252538|E1|Reported Event|Group 1|"Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus, 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months~interferon-alpha: This is an observational study only. The patients are on interferon alpha therapy for HCV, but prescribing interferon is not a part of this research study protocol."
1214157|NCT00252512|B3|Baseline|Total|Total of all reporting groups
1214158|NCT00252512|B2|Baseline|Placebo|"Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.~Placebo: Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results."
1214159|NCT00252512|B1|Baseline|Contingency Management|"Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are negative, they receive a chance to draw tokens from a bowl. Some tokens are social reinforcement. Others have monetary value ($1, $20 or $80 canteen voucher).~Contingency Management: Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value ($1, $20, or $80 canteen voucher)."
1214591|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
1214160|NCT00252512|P2|Participant Flow|Placebo|"Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.~Placebo: Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results."
1214161|NCT00252512|P1|Participant Flow|Contingency Management|"Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are negative, they receive a chance to draw tokens from a bowl. Some tokens are social reinforcement. Others have monetary value ($1, $20 or $80 canteen voucher).~Contingency Management: Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value ($1, $20, or $80 canteen voucher)."
1214593|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
1214162|NCT00252512|O2|Outcome|Arm 2|"Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.~Placebo: Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results."
1214163|NCT00252512|O1|Outcome|Arm 1|"Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are negative, they receive a chance to draw tokens from a bowl. Some tokens are social reinforcement. Others have monetary value ($1, $20 or $80 canteen voucher).~Contingency Management: Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value ($1, $20, or $80 canteen voucher)."
1214164|NCT00252512|E2|Reported Event|Baseline|"Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.~Placebo: Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results."
1214165|NCT00252512|E1|Reported Event|Contingency Management|"Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are negative, they receive a chance to draw tokens from a bowl. Some tokens are social reinforcement. Others have monetary value ($1, $20 or $80 canteen voucher).~Contingency Management: Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value ($1, $20, or $80 canteen voucher)."
1214166|NCT00252499|B4|Baseline|Total|Total of all reporting groups
1214167|NCT00252499|B3|Baseline|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
1214168|NCT00252499|B2|Baseline|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
1214169|NCT00252499|B1|Baseline|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
1214170|NCT00252499|P3|Participant Flow|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
1214171|NCT00252499|P2|Participant Flow|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
1214172|NCT00252499|P1|Participant Flow|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
1214173|NCT00252499|O3|Outcome|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
1214174|NCT00252499|O2|Outcome|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
1214175|NCT00252499|O1|Outcome|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
1214176|NCT00252499|O3|Outcome|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
1214177|NCT00252499|O2|Outcome|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
1214178|NCT00252499|O1|Outcome|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
1214179|NCT00252499|O3|Outcome|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
1214180|NCT00252499|O2|Outcome|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
1214181|NCT00252499|O1|Outcome|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
1214182|NCT00252499|O3|Outcome|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
1214183|NCT00252499|O2|Outcome|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
1214184|NCT00252499|O1|Outcome|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
1214185|NCT00252499|O3|Outcome|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
1214186|NCT00252499|O2|Outcome|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
1214187|NCT00252499|O1|Outcome|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
1214188|NCT00252499|O3|Outcome|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
1214189|NCT00252499|O2|Outcome|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
1214190|NCT00252499|O1|Outcome|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
1214191|NCT00252499|E3|Reported Event|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
1214192|NCT00252499|E2|Reported Event|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
1214193|NCT00252499|E1|Reported Event|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
1214194|NCT00252239|B5|Baseline|Total|Total of all reporting groups
1214195|NCT00252239|B4|Baseline|tPA 0.9 mg/kg|"tissue plasminogen activator, tPA~tissue plasminogen activator, tPA: To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke."
1214196|NCT00252239|B3|Baseline|TNK 0.4 mg/kg|Highest dose tenecteplase
1214197|NCT00252239|B2|Baseline|TNK 0.25 mg/kg|Medium dose tenecteplase
1214198|NCT00252239|B1|Baseline|TNK 0.1 mg/kg|Lowest dose tenecteplase
1214199|NCT00252239|P4|Participant Flow|tPA 0.9 mg/kg|"tissue plasminogen activator, tPA~tissue plasminogen activator, tPA: To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke."
1214200|NCT00252239|P3|Participant Flow|TNK 0.4 mg/kg|Highest dose tenecteplase
1214201|NCT00252239|P2|Participant Flow|TNK 0.25 mg/kg|Medium dose tenecteplase
1214202|NCT00252239|P1|Participant Flow|TNK 0.1 mg/kg|Lowest dose tenecteplase
1214203|NCT00252239|O4|Outcome|tPA 0.9 mg/kg|"tissue plasminogen activator, tPA~tissue plasminogen activator, tPA: To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke."
1214204|NCT00252239|O3|Outcome|TNK 0.4 mg/kg|Highest dose tenecteplase
1214205|NCT00252239|O2|Outcome|TNK 0.25 mg/kg|Medium dose tenecteplase
1214206|NCT00252239|O1|Outcome|TNK 0.1 mg/kg|Lowest dose tenecteplase
1214207|NCT00252239|E4|Reported Event|tPA 0.9 mg/kg|"tissue plasminogen activator, tPA~tissue plasminogen activator, tPA: To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke."
1214208|NCT00252239|E3|Reported Event|TNK 0.4 mg/kg|Highest dose tenecteplase
1214209|NCT00252239|E2|Reported Event|TNK 0.25 mg/kg|Medium dose tenecteplase
1214213|NCT00252187|B1|Baseline|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
1214214|NCT00252187|P2|Participant Flow|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
1214215|NCT00252187|P1|Participant Flow|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
1214216|NCT00252187|O2|Outcome|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
1214217|NCT00252187|O1|Outcome|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
1214218|NCT00252187|O2|Outcome|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
1214219|NCT00252187|O1|Outcome|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
1214220|NCT00252187|O2|Outcome|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
1214221|NCT00252187|O1|Outcome|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
1214222|NCT00252187|O2|Outcome|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
1214223|NCT00252187|O1|Outcome|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
1214224|NCT00252187|O2|Outcome|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
1214225|NCT00252187|O1|Outcome|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
1214226|NCT00252187|O2|Outcome|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
1214227|NCT00252187|O1|Outcome|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
1214228|NCT00252187|O2|Outcome|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
1214229|NCT00252187|O1|Outcome|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
1214230|NCT00252187|O2|Outcome|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
1214231|NCT00252187|O1|Outcome|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
1214232|NCT00252187|E2|Reported Event|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks
1214233|NCT00252187|E1|Reported Event|BPN Group|BNP (nesiritide) administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
1214234|NCT00252174|B4|Baseline|Total|Total of all reporting groups
1214235|NCT00252174|B3|Baseline|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
1214236|NCT00252174|B2|Baseline|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I~3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule~Dosage frequency and duration for the control arm (4 subjects):~Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
1214237|NCT00252174|B1|Baseline|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
1214238|NCT00252174|P3|Participant Flow|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
1214239|NCT00252174|P2|Participant Flow|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I~3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule~Dosage frequency and duration for the control arm (4 subjects):~Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
1214295|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
1214296|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
1214240|NCT00252174|P1|Participant Flow|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
1214241|NCT00252174|O3|Outcome|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
1214242|NCT00252174|O2|Outcome|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I~3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule~Dosage frequency and duration for the control arm (4 subjects):~Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
1214243|NCT00252174|O1|Outcome|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
1214244|NCT00252174|O3|Outcome|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
1214245|NCT00252174|O2|Outcome|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I~3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule~Dosage frequency and duration for the control arm (4 subjects):~Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
1214246|NCT00252174|O1|Outcome|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
1214247|NCT00252174|O3|Outcome|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
1214248|NCT00252174|O2|Outcome|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I~3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule~Dosage frequency and duration for the control arm (4 subjects):~Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
1214249|NCT00252174|O1|Outcome|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
1214250|NCT00252174|O3|Outcome|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
1214251|NCT00252174|O2|Outcome|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I~3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule~Dosage frequency and duration for the control arm (4 subjects):~Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
1214252|NCT00252174|O1|Outcome|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
1214297|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
1214298|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
1214592|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
1214253|NCT00252174|O3|Outcome|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
1214254|NCT00252174|O2|Outcome|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I~3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule~Dosage frequency and duration for the control arm (4 subjects):~Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
1214594|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
1214255|NCT00252174|O1|Outcome|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
1214256|NCT00252174|O3|Outcome|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
1214257|NCT00252174|O2|Outcome|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I~3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule~Dosage frequency and duration for the control arm (4 subjects):~Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
1214258|NCT00252174|O1|Outcome|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
1214259|NCT00252174|O3|Outcome|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
1214260|NCT00252174|O2|Outcome|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I~3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule~Dosage frequency and duration for the control arm (4 subjects):~Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
1214261|NCT00252174|O1|Outcome|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
1214262|NCT00252174|O3|Outcome|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
1214263|NCT00252174|O2|Outcome|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I~3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule~Dosage frequency and duration for the control arm (4 subjects):~Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
1214264|NCT00252174|O1|Outcome|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
1214265|NCT00252174|O3|Outcome|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
1214299|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
1214300|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
1214266|NCT00252174|O2|Outcome|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I~3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule~Dosage frequency and duration for the control arm (4 subjects):~Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
1214267|NCT00252174|O1|Outcome|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
1214595|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
1214268|NCT00252174|O3|Outcome|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
1214269|NCT00252174|O2|Outcome|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I~3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule~Dosage frequency and duration for the control arm (4 subjects):~Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
1214270|NCT00252174|O1|Outcome|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
1214271|NCT00252174|E3|Reported Event|Stage 2, Active|"The 4 subjects assigned in Stage I to the control arm will have the option to continue into Stage 2 to repeat the experimental procedures of Stage I but with open-label MDMA at the near-full to full dosage strength.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
1214272|NCT00252174|E2|Reported Event|Stage 1, Control|"4 individuals will receive sub-threshold to threshold minimal doses of MDMA in Stage I~3,4-methylenedioxymethamphetamine (MDMA): Drug: Dosage form: capsule~Dosage frequency and duration for the control arm (4 subjects):~Session 1: 25 mg followed 2.5 hours later with optional 12.5 mg for total of 37.5 g Session 2 (two to three weeks later): 25 mg followed 2.5 hours later with optional 12.5mg for total of 37.5mg."
1214273|NCT00252174|E1|Reported Event|Stage 1, Active|"8 subjects will receive full or nearly full doses of MDMA in Stage 1 and do not continue to participate into Stage 2.~3,4-methylenedioxymethamphetamine (MDMA): Dosage form: capsule~Dosage frequency and duration for the treatment arm (8 subjects in Stage 1 and the other 4 subjects in Stage 1 who may continue into Stage 2):~Session 1: 83.3mg followed 2.5 hours later with optional 41.7 mg for total of 125mg Session 2 (two to three weeks later): 125mg followed 2.5 hours later with optional 62.5mg for total of 187.5 mg."
1214274|NCT00252057|B3|Baseline|Total|Total of all reporting groups
1214275|NCT00252057|B2|Baseline|Standard Hospital Discharge|Participants received the routine, standard hospital discharge.
1214276|NCT00252057|B1|Baseline|Re-engineered Hospital Discharge|"Participants received the Re-Engineered Hospital Discharge, a set of 11 discrete, mutually reinforcing components provided by a Discharge Advocate and re-enforced by a telephone call 2-4 days after discharge by a clinical pharmacist."
1214277|NCT00252057|P2|Participant Flow|Standard Hospital Discharge|Participants received the routine, standard hospital discharge.
1214278|NCT00252057|P1|Participant Flow|Re-engineered Hospital Discharge|"Participants received the Re-Engineered Hospital Discharge, a set of 11 discrete, mutually reinforcing components provided by a Discharge Advocate and re-enforced by a telephone call 2-4 days after discharge by a clinical pharmacist."
1214279|NCT00252057|O2|Outcome|Standard Hospital Discharge|Participants received the routine, standard hospital discharge.
1214280|NCT00252057|O1|Outcome|Re-engineered Hospital Discharge|"Participants received the Re-Engineered Hospital Discharge, a set of 11 discrete, mutually reinforcing components provided by a Discharge Advocate and re-enforced by a telephone call 2-4 days after discharge by a clinical pharmacist."
1214281|NCT00252057|E2|Reported Event|Standard Hospital Discharge|Participants received the routine, standard hospital discharge.
1214282|NCT00252057|E1|Reported Event|Re-engineered Hospital Discharge|"Participants received the Re-Engineered Hospital Discharge, a set of 11 discrete, mutually reinforcing components provided by a Discharge Advocate and re-enforced by a telephone call 2-4 days after discharge by a clinical pharmacist."
1214283|NCT00251979|B3|Baseline|Total|Total of all reporting groups
1214284|NCT00251979|B2|Baseline|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
1214285|NCT00251979|B1|Baseline|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
1214286|NCT00251979|P2|Participant Flow|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
1214287|NCT00251979|P1|Participant Flow|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
1214288|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
1214289|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
1214290|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
1214291|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
1214292|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
1214301|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
1214302|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
1214303|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
1214304|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
1214305|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
1214306|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
1214307|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
1214596|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
1214308|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
1214309|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
1214310|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
1214311|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
1214312|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
1214313|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
1214314|NCT00251979|E2|Reported Event|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
1214315|NCT00251979|E1|Reported Event|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
1214316|NCT00251758|B4|Baseline|Total|Total of all reporting groups
1214317|NCT00251758|B3|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
1214318|NCT00251758|B2|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
1214319|NCT00251758|B1|Baseline|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
1214320|NCT00251758|P3|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
1214321|NCT00251758|P2|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
1214322|NCT00251758|P1|Participant Flow|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
1214323|NCT00251758|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
1214324|NCT00251758|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
1214325|NCT00251758|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
1214326|NCT00251758|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
1214327|NCT00251758|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
1214328|NCT00251758|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
1214329|NCT00251758|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
1214330|NCT00251758|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
1214331|NCT00251758|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
1214332|NCT00251758|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
1214333|NCT00251758|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
1214334|NCT00251758|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
1214335|NCT00251758|E3|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
1214336|NCT00251758|E2|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
1214337|NCT00251758|E1|Reported Event|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
1214338|NCT00251745|B4|Baseline|Total|Total of all reporting groups
1214339|NCT00251745|B3|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
1214340|NCT00251745|B2|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
1214341|NCT00251745|B1|Baseline|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
1214342|NCT00251745|P3|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
1214343|NCT00251745|P2|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
1214344|NCT00251745|P1|Participant Flow|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
1214345|NCT00251745|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
1214346|NCT00251745|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
1214347|NCT00251745|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
1214348|NCT00251745|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
1214349|NCT00251745|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
1214350|NCT00251745|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
1214351|NCT00251745|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
1214352|NCT00251745|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
1214353|NCT00251745|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
1214354|NCT00251745|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
1214569|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
1214355|NCT00251745|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
1214356|NCT00251745|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
1214357|NCT00251745|E3|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
1214358|NCT00251745|E2|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
1214359|NCT00251745|E1|Reported Event|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
1214360|NCT00251719|B4|Baseline|Total|Total of all reporting groups
1214361|NCT00251719|B3|Baseline|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
1214597|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
1214362|NCT00251719|B2|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
1214363|NCT00251719|B1|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
1214364|NCT00251719|P3|Participant Flow|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
1214365|NCT00251719|P2|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
1214366|NCT00251719|P1|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
1214367|NCT00251719|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
1214368|NCT00251719|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
1214369|NCT00251719|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
1214370|NCT00251719|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
1214371|NCT00251719|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
1214372|NCT00251719|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
1214373|NCT00251719|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
1214374|NCT00251719|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
1214375|NCT00251719|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
1214376|NCT00251719|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
1214377|NCT00251719|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
1214378|NCT00251719|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
1214379|NCT00251719|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
1214380|NCT00251719|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
1214381|NCT00251719|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
1214382|NCT00251719|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
1214383|NCT00251719|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
1214384|NCT00251719|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
1214385|NCT00251719|E3|Reported Event|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
1214386|NCT00251719|E2|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
1214387|NCT00251719|E1|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
1214388|NCT00251693|B4|Baseline|Total|Total of all reporting groups
1214389|NCT00251693|B3|Baseline|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
1214390|NCT00251693|B2|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
1214391|NCT00251693|B1|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
1214392|NCT00251693|P3|Participant Flow|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
1214393|NCT00251693|P2|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
1214394|NCT00251693|P1|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
1214395|NCT00251693|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
1214396|NCT00251693|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
1214397|NCT00251693|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
1214398|NCT00251693|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
1214399|NCT00251693|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
1214400|NCT00251693|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
1214401|NCT00251693|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
1214402|NCT00251693|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
1214403|NCT00251693|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
1214404|NCT00251693|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
1214405|NCT00251693|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
1214406|NCT00251693|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
1214407|NCT00251693|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
1214408|NCT00251693|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
1214409|NCT00251693|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
1214410|NCT00251693|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
1214411|NCT00251693|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
1214412|NCT00251693|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
1214413|NCT00251693|E3|Reported Event|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
1214414|NCT00251693|E2|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
1214415|NCT00251693|E1|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
1214416|NCT00251641|B3|Baseline|Total|Total of all reporting groups
1214417|NCT00251641|B2|Baseline|Methotrexate|Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
1214418|NCT00251641|B1|Baseline|Infliximab|The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
1214419|NCT00251641|P2|Participant Flow|Methotrexate|Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
1214420|NCT00251641|P1|Participant Flow|Infliximab|The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
1214421|NCT00251641|O2|Outcome|Methotrexate|Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
1214422|NCT00251641|O1|Outcome|Infliximab|The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
1214423|NCT00251641|O2|Outcome|Methotrexate|Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
1214424|NCT00251641|O1|Outcome|Infliximab|The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
1214425|NCT00251641|O2|Outcome|Methotrexate|Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
1214426|NCT00251641|O1|Outcome|Infliximab|The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
1214427|NCT00251641|O2|Outcome|Methotrexate|Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
1214428|NCT00251641|O1|Outcome|Infliximab|The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
1214429|NCT00251641|E4|Reported Event|Participants Who Switched From Methotrexate to Infliximab|Adverse events reported for participants who switched from methotrexate to infliximab at Week 16 (including only adverse events with begin dates on or after a switch in treatment).
1214430|NCT00251641|E3|Reported Event|Participants Who Switched From Infliximab to Methotrexate|Adverse events reported for participants who switched from infliximab to methotrexate at Week 16 (including only adverse events with begin dates on or after a switch in treatment).
1214431|NCT00251641|E2|Reported Event|Methotrexate|Adverse events reported through Week 26 for participants who did not switch treatment at Week 16 and adverse reported through Week 16 for those participants who switched treatment.
1214570|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
1214571|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
1214432|NCT00251641|E1|Reported Event|Infliximab|Adverse events reported through Week 26 for participants who did not switch treatment at Week 16 and adverse reported through Week 16 for those participants who switched treatment.
1214433|NCT00251589|B5|Baseline|Total|Total of all reporting groups
1214434|NCT00251589|B4|Baseline|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
1214598|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
1214435|NCT00251589|B3|Baseline|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
1214436|NCT00251589|B2|Baseline|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
1214437|NCT00251589|B1|Baseline|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
1214438|NCT00251589|P4|Participant Flow|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
1214439|NCT00251589|P3|Participant Flow|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
1214440|NCT00251589|P2|Participant Flow|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
1214441|NCT00251589|P1|Participant Flow|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
1214442|NCT00251589|O1|Outcome|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
1214443|NCT00251589|O4|Outcome|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
1214444|NCT00251589|O3|Outcome|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
1214445|NCT00251589|O2|Outcome|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
1214446|NCT00251589|O1|Outcome|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
1214447|NCT00251589|O4|Outcome|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
1214448|NCT00251589|O3|Outcome|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
1214449|NCT00251589|O2|Outcome|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
1214450|NCT00251589|O1|Outcome|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
1214451|NCT00251589|O4|Outcome|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
1214452|NCT00251589|O3|Outcome|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
1214453|NCT00251589|O2|Outcome|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
1214599|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
1214454|NCT00251589|O1|Outcome|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
1214455|NCT00251589|O4|Outcome|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
1214456|NCT00251589|O3|Outcome|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
1214457|NCT00251589|O2|Outcome|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
1214458|NCT00251589|O1|Outcome|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
1214459|NCT00251589|O4|Outcome|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
1214460|NCT00251589|O3|Outcome|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
1214461|NCT00251589|O2|Outcome|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
1214462|NCT00251589|O1|Outcome|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
1214463|NCT00251589|O4|Outcome|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
1214464|NCT00251589|O3|Outcome|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
1214465|NCT00251589|O2|Outcome|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
1214466|NCT00251589|O1|Outcome|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
1214467|NCT00251589|O4|Outcome|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
1214468|NCT00251589|O3|Outcome|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
1214469|NCT00251589|O2|Outcome|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
1214470|NCT00251589|O1|Outcome|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
1214572|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
1214573|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
1214471|NCT00251589|E4|Reported Event|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
1214600|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
1214601|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
1214602|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
1214472|NCT00251589|E3|Reported Event|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
1214473|NCT00251589|E2|Reported Event|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
1214474|NCT00251589|E1|Reported Event|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
1214475|NCT00251316|B3|Baseline|Total|Total of all reporting groups
1214476|NCT00251316|B2|Baseline|Placebo|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive placebo (look-alike capsules with no active ingredient).
1214477|NCT00251316|B1|Baseline|Lithium Carbonate|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive lithium capsules.
1214478|NCT00251316|P2|Participant Flow|Placebo|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive placebo (look-alike capsules with no active ingredient).
1214479|NCT00251316|P1|Participant Flow|Lithium Carbonate|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive lithium capsules.
1214480|NCT00251316|O2|Outcome|Placebo|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive placebo (look-alike capsules with no active ingredient).
1214481|NCT00251316|O1|Outcome|Lithium Carbonate|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive lithium capsules.
1214482|NCT00251316|E2|Reported Event|Placebo|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive placebo (look-alike capsules with no active ingredient).
1214483|NCT00251316|E1|Reported Event|Lithium Carbonate|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive lithium capsules.
1214484|NCT00251303|B3|Baseline|Total|Total of all reporting groups
1214485|NCT00251303|B2|Baseline|Placebo|"Placebo capsules were prepared by NIH Clinical Center Pharmacy to appear identical to active drug capsules. Dose was titrated upward as if active drug. Follow-up and laboratory studies were identical for active drug and placebo arms. At the end of the double-blind phase, subjects could elect to take open-label drug, which was titrated upward to the maximum dose, 100 mg daily.~Study blind was not broken for subjects or investigators until the final subject had completed the double-blind phase of the study."
1214486|NCT00251303|B1|Baseline|Riluzole|"In a 12-weeks long double-blind phase, the clinicians and subjects and their guardians were blind to active drug or placebo. There were approx. twice monthly in-person or telephone contacts.~Riluzole was titrated upward to at least 100 mg of active drug. If adverse effects are noted, dose titration was slowed, stopped, or reversed, or the drug was discontinued. Maximum permitted dose of riluzole was 120 mg/day. At the end of the 12 weeks study period, subjects and their families could elect to take open-label riluzole.Since neither subjects nor investigators knew whether subjects had been receiving active drug,the open-label administration was also titrated. Laboratory assays were obtained at 2, 4, 8, and 12 weeks after starting the open-label riluzole, as they had been during double-blind. Subsequently, testing was less frequent."
1214487|NCT00251303|P2|Participant Flow|Placebo|Placebo capsules were prepared by NIH Clinical Center Pharmacy to appear identical to active drug capsules. Dose was titrated upward as if active drug. Follow-up and laboratory studies were identical for active drug and placebo arms.
1214488|NCT00251303|P1|Participant Flow|Riluzole|Riluzole was titrated upward to at least 100 mg of active drug. If adverse effects are noted, dose titration was slowed, stopped, or reversed, or the drug was discontinued. Maximum permitted dose of riluzole was 120 mg/day.
1214489|NCT00251303|O2|Outcome|Placebo|Placebo capsules were prepared by NIH Clinical Center Pharmacy to appear identical to active drug capsules. Dose was titrated upward as if active drug. Follow-up and laboratory studies were identical for active drug and placebo arms.
1214490|NCT00251303|O1|Outcome|Riluzole|Riluzole was titrated upward to at least 100 mg of active drug. If adverse effects are noted, dose titration was slowed, stopped, or reversed, or the drug was discontinued. Maximum permitted dose of riluzole was 120 mg/day.
1214491|NCT00251303|O2|Outcome|Placebo|"Placebo capsules were prepared by NIH Clinical Center Pharmacy to appear identical to active drug capsules. Dose was titrated upward as if active drug. Follow-up and laboratory studies were identical for active drug and placebo arms. At the end of the double-blind phase, subjects could elect to take open-label drug, which was titrated upward to the maximum dose, 100 mg daily.~Study blind was not broken for subjects or investigators until the final subject had completed the double-blind phase of the study."
1214574|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
1214575|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
1214603|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
1214604|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
1214605|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
1214606|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
1214607|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
1214608|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
1214492|NCT00251303|O1|Outcome|Riluzole|"In a 12-weeks long double-blind phase, the clinicians and subjects and their guardians were blind to active drug or placebo. There were approx. twice monthly in-person or telephone contacts.~Riluzole was titrated upward to at least 100 mg of active drug. If adverse effects are noted, dose titration was slowed, stopped, or reversed, or the drug was discontinued. Maximum permitted dose of riluzole was 120 mg/day. At the end of the 12 weeks study period, subjects and their families could elect to take open-label riluzole.Since neither subjects nor investigators knew whether subjects had been receiving active drug,the open-label administration was also titrated. Laboratory assays were obtained at 2, 4, 8, and 12 weeks after starting the open-label riluzole, as they had been during double-blind. Subsequently, testing was less frequent."
1214493|NCT00251303|E2|Reported Event|Placebo|"Placebo capsules were prepared by NIH Clinical Center Pharmacy to appear identical to active drug capsules. Dose was titrated upward as if active drug. Follow-up and laboratory studies were identical for active drug and placebo arms. At the end of the double-blind phase, subjects could elect to take open-label drug, which was titrated upward to the maximum dose, 100 mg daily.~Study blind was not broken for subjects or investigators until the final subject had completed the double-blind phase of the study."
1214494|NCT00251303|E1|Reported Event|Riluzole|"In a 12-weeks long double-blind phase, the clinicians and subjects and their guardians were blind to active drug or placebo. There were approx. twice monthly in-person or telephone contacts.~Riluzole was titrated upward to at least 100 mg of active drug. If adverse effects are noted, dose titration was slowed, stopped, or reversed, or the drug was discontinued. Maximum permitted dose of riluzole was 120 mg/day. At the end of the 12 weeks study period, subjects and their families could elect to take open-label riluzole.Since neither subjects nor investigators knew whether subjects had been receiving active drug,the open-label administration was also titrated. Laboratory assays were obtained at 2, 4, 8, and 12 weeks after starting the open-label riluzole, as they had been during double-blind. Subsequently, testing was less frequent."
1214495|NCT00251238|B3|Baseline|Total|Total of all reporting groups
1214496|NCT00251238|B2|Baseline|Control Group|Receiving matching placebo
1214497|NCT00251238|B1|Baseline|Intervention Group|active treatment group, receiving film coated 120 mg Ginkgo Biloba special extract (EGb 761) two times a day for 10 weeks
1214498|NCT00251238|P2|Participant Flow|Placebo Group|receiving matching placebo
1214499|NCT00251238|P1|Participant Flow|Intervention Group|active treatment group, receiving oral film-coated tablet of 120-mg Ginkgo Biloba special extract (EGb 761) 2 times a day for 10 weeks, after an initial 2-week run-in phase
1214500|NCT00251238|O2|Outcome|Placebo Group|receiving placebo
1214501|NCT00251238|O1|Outcome|Intervention Group|active treatment group (EGb 761)
1214502|NCT00251238|O2|Outcome|Placebo Group|receiving placebo
1214503|NCT00251238|O1|Outcome|Intervention Group|active treatment group (EGb 761)
1214504|NCT00251238|O2|Outcome|Placebo Group|receiving placebo
1214505|NCT00251238|O1|Outcome|Intervention Group|active treatment group (EGb 761)
1214506|NCT00251238|E2|Reported Event|Placebo Group|receiving placebo
1214507|NCT00251238|E1|Reported Event|Intervention Group|active treatment group (EGb 761)
1214508|NCT00251004|B4|Baseline|Total|Total of all reporting groups
1214509|NCT00251004|B3|Baseline|Control Group|"1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
1214510|NCT00251004|B2|Baseline|High-dose Everolimus Group|"3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
1214511|NCT00251004|B1|Baseline|Low-dose Everolimus Group|"1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
1214512|NCT00251004|P3|Participant Flow|Control Group|"1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
1214513|NCT00251004|P2|Participant Flow|High-dose Everolimus Group|"3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
1214514|NCT00251004|P1|Participant Flow|Low-dose Everolimus Group|"1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
1214515|NCT00251004|O3|Outcome|Control Group|"1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
1214516|NCT00251004|O2|Outcome|High-dose Everolimus Group|"3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
1214517|NCT00251004|O1|Outcome|Low-dose Everolimus Group|"1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
1214518|NCT00251004|O3|Outcome|Control Group|"1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
1214519|NCT00251004|O2|Outcome|High-dose Everolimus Group|"3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
1214520|NCT00251004|O1|Outcome|Low-dose Everolimus Group|"1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
1214521|NCT00251004|O3|Outcome|Control Group|"1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
1214522|NCT00251004|O2|Outcome|High-dose Everolimus Group|"3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
1214523|NCT00251004|O1|Outcome|Low-dose Everolimus Group|"1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
1214524|NCT00251004|O3|Outcome|Control Group|"1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
1214525|NCT00251004|O2|Outcome|High-dose Everolimus Group|"3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
1214526|NCT00251004|O1|Outcome|Low-dose Everolimus Group|"1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
1214527|NCT00251004|E3|Reported Event|Control Group|"1.44 g Mycophenolic Acid (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
1214528|NCT00251004|E2|Reported Event|High-dose Everolimus Group|"3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
1214529|NCT00251004|E1|Reported Event|Low-dose Everolimus Group|"1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
1214530|NCT00250926|B1|Baseline|Bortezomib, Dexamethasone, Rituximab|A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.
1214531|NCT00250926|P1|Participant Flow|Bortezomib, Dexamethasone, Rituximab|A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.
1214532|NCT00250926|O1|Outcome|Bortezomib, Dexamethasone, Rituximab|"A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.~Bortezomib: Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles~Dexamethasone: Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles~Rituximab: Given intravenously after bortezomib and dexamethasone on day 11 of a 21-day cycle for 8 cycles"
1214533|NCT00250926|O1|Outcome|Bortezomib, Dexamethasone, Rituximab|"A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.~Bortezomib: Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles~Dexamethasone: Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles~Rituximab: Given intravenously after bortezomib and dexamethasone on day 11 of a 21-day cycle for 8 cycles"
1214534|NCT00250926|O1|Outcome|Bortezomib, Dexamethasone, Rituximab|A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.
1214535|NCT00250926|O1|Outcome|Bortezomib, Dexamethasone, Rituximab|A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.
1214536|NCT00250926|E1|Reported Event|Bortezomib, Dexamethasone, Rituximab|A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.
1214537|NCT00250835|B1|Baseline|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.~Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).~Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.~Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
1214538|NCT00250835|P1|Participant Flow|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.~Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).~Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.~Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
1214539|NCT00250835|O1|Outcome|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.~Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).~Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.~Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
1214540|NCT00250835|O1|Outcome|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.~Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).~Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.~Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
1214576|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
1214541|NCT00250835|O1|Outcome|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.~Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).~Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.~Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
1214542|NCT00250835|O1|Outcome|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.~Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).~Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.~Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
1214543|NCT00250835|O1|Outcome|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.~Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).~Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.~Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
1214544|NCT00250835|O1|Outcome|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.~Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).~Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.~Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
1214545|NCT00250835|E1|Reported Event|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.~Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).~Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.~Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
1214546|NCT00250718|B1|Baseline|Arm 1 Combination Treatment|"VP-16 at 50 mg/day, orally for 14 days every 28 days; Chlorambucil at 0.1 mg/kg/day orally for 14 days every 28 days; Vincristine at 2 mg intravenously every 14 days; Dexamethasone at 200 mg intravenously every 24 days; Rituxan (rituximab) at 375 mg/m2 intravenously every 14 day; Levofloxacin at 500 mg orally daily; Diflucan at 200 mg orally daily~One cycle lasts 28 days. At least 2 but no more than 8 cycles will be administered to each patient"
1214547|NCT00250718|P1|Participant Flow|Arm 1 Combination Treatment|"VP-16 at 50 mg/day, orally for 14 days every 28 days; Chlorambucil at 0.1 mg/kg/day orally for 14 days every 28 days; Vincristine at 2 mg intravenously every 14 days; Dexamethasone at 200 mg intravenously every 24 days; Rituxan (rituximab) at 375 mg/m2 intravenously every 14 day; Levofloxacin at 500 mg orally daily; Diflucan at 200 mg orally daily~One cycle lasts 28 days. At least 2 but no more than 8 cycles will be administered to each patient"
1214548|NCT00250718|O1|Outcome|Arm 1 Combination Treatment|"VP-16 at 50 mg/day, orally for 14 days every 28 days; Chlorambucil at 0.1 mg/kg/day orally for 14 days every 28 days; Vincristine at 2 mg intravenously every 14 days; Dexamethasone at 200 mg intravenously every 24 days; Rituxan (rituximab) at 375 mg/m2 intravenously every 14 day; Levofloxacin at 500 mg orally daily; Diflucan at 200 mg orally daily~One cycle lasts 28 days. At least 2 but no more than 8 cycles will be administered to each patient"
1214549|NCT00250718|O1|Outcome|Arm 1 Combination Treatment|"VP-16 at 50 mg/day, orally for 14 days every 28 days; Chlorambucil at 0.1 mg/kg/day orally for 14 days every 28 days; Vincristine at 2 mg intravenously every 14 days; Dexamethasone at 200 mg intravenously every 24 days; Rituxan (rituximab) at 375 mg/m2 intravenously every 14 day; Levofloxacin at 500 mg orally daily; Diflucan at 200 mg orally daily~One cycle lasts 28 days. At least 2 but no more than 8 cycles will be administered to each patient"
1214550|NCT00250718|E1|Reported Event|Arm 1 Combination Treatment|"VP-16 50mg/d PO x14 days q 28 days + Chlorambucil 0.1mg/kg/d PO x14 days q 28 days + Vincristine 2mg IV x14 days + Dexamethasone 200mg IV q 24 days + Rituxan (rituximab) 375 mg/m2 IVI x14 days + Levofloxacin 500 mg PO qd + Diflucan 200 mg PO qd~Vincristine: should be administered intravenously through a freely-running IV at 2mg q 14 days.~VP-16: The VP-16 is optional for the first cycle if the patient has delays in obtaining the drug. Dose and schedule 50 mg/d P.O. x14 days q 28 days.~Rituximab: The total amount of rituximab needed for a patient's entire infusions (one course) will be determined at study entry. A single dose of 375 mg/m2 will be based upon the patient's actual body surface area calculated during the baseline evaluation. The dose level of rituximab will not be adjusted.~Dexamethasone: Dexamethasone will be administered at 200mg q 14 days. Dexamethasone should be administered over a 1 hour infusion.~Levofloxacin: Levofloxacin will be administ"
1214551|NCT00250679|B4|Baseline|Total|Total of all reporting groups
1214552|NCT00250679|B3|Baseline|Arformoterol 25 Mcg 2x/Day|
1214553|NCT00250679|B2|Baseline|Arformoterol 15 Mcg 2x/Day|
1214554|NCT00250679|B1|Baseline|Formoterol 12 Mcg 2x/Day|
1214555|NCT00250679|P3|Participant Flow|Arformoterol 25 Mcg 2x/Day|
1214556|NCT00250679|P2|Participant Flow|Arformoterol 15 Mcg 2x/Day|
1214557|NCT00250679|P1|Participant Flow|Formoterol 12 Mcg 2x/Day|
1214558|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
1214559|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
1214560|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
1214561|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
1214562|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
1214563|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
1214564|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
1214565|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
1214566|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
1214567|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
1214568|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
1214627|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
1214628|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
1214629|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
1214630|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
1214631|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
1214632|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
1214633|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
1214634|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
1214635|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
1214636|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
1214637|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
1214638|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
1214639|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
1214640|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
1214641|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
1214642|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
1214643|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
1214644|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
1214645|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
1214646|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
1214647|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
1214648|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
1214649|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
1214650|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
1214651|NCT00250679|E3|Reported Event|Arformoterol 25 Mcg 2x/Day|
1214652|NCT00250679|E2|Reported Event|Arformoterol 15 Mcg 2x/Day|
1214653|NCT00250679|E1|Reported Event|Formoterol 12 Mcg 2x/Day|
1214654|NCT00250588|B4|Baseline|Total|Total of all reporting groups
1214655|NCT00250588|B3|Baseline|Standard Care|The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
1214656|NCT00250588|B2|Baseline|Care Coordination+Problem Solving|The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework – identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework – defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework – implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
1214657|NCT00250588|B1|Baseline|Care Coordination|The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor’s level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
1214658|NCT00250588|P3|Participant Flow|Standard Care|The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
1214766|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
1214767|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
1214659|NCT00250588|P2|Participant Flow|Care Coordination+Problem Solving|The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework - identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework - defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework - implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
1214660|NCT00250588|P1|Participant Flow|Care Coordination|The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor's level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
1214661|NCT00250588|O3|Outcome|Standard Care|The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
1214716|NCT00250432|B1|Baseline|Caspofungin 70/50 mg|Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)
1214717|NCT00250432|P2|Participant Flow|Caspofungin 150 mg|Caspofungin 150 mg IV daily
1214718|NCT00250432|P1|Participant Flow|Caspofungin 70/50 mg|Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)
1214662|NCT00250588|O2|Outcome|Care Coordination+Problem Solving|The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework - identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework - defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework - implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
1214663|NCT00250588|O1|Outcome|Care Coordination|The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor's level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
1214664|NCT00250588|O3|Outcome|Standard Care|The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
1214665|NCT00250588|O2|Outcome|Care Coordination+Problem Solving|The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework - identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework - defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework - implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
1214666|NCT00250588|O1|Outcome|Care Coordination|The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor's level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
1214667|NCT00250588|O3|Outcome|Standard Care|The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
1214698|NCT00250484|O1|Outcome|Transcranial Magnetic Stimulation|"Active treatment with TMS for 10 days.~Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
1214699|NCT00250484|O2|Outcome|Sham Transcranial Magnetic Stimulation|"Patients will receive no active TMS/treatment.~Sham Transcranial Magnetic Stimulation: Sham procedure of transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
1214700|NCT00250484|O1|Outcome|Transcranial Magnetic Stimulation|"Active treatment with TMS for 10 days.~Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
1214768|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
1214668|NCT00250588|O2|Outcome|Care Coordination+Problem Solving|The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework - identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework - defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework - implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
1214669|NCT00250588|O1|Outcome|Care Coordination|The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor's level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
1214670|NCT00250588|E3|Reported Event|Standard Care|The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
1214671|NCT00250588|E2|Reported Event|Care Coordination+Problem Solving|The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework - identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework - defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework - implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
1214672|NCT00250588|E1|Reported Event|Care Coordination|The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor's level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
1214673|NCT00250497|B3|Baseline|Total|Total of all reporting groups
1214674|NCT00250497|B2|Baseline|Control Group|All Girls PE Control Group
1214675|NCT00250497|B1|Baseline|Intervention Group|New Moves Intervention
1214676|NCT00250497|P2|Participant Flow|Control Group|All Girls PE Control group
1214677|NCT00250497|P1|Participant Flow|Intervention Group|New Moves Intervention
1214678|NCT00250497|O2|Outcome|Control Group|All Girls PE Control Group
1214679|NCT00250497|O1|Outcome|Intervention Group|New Moves Intervention Group
1214680|NCT00250497|O2|Outcome|Control Group|All Girls PE Control Group
1214681|NCT00250497|O1|Outcome|Intervention Group|New Moves Intervention Group
1214682|NCT00250497|O2|Outcome|Control Group|All Girls PE Control Group
1214683|NCT00250497|O1|Outcome|Intervention Group|New Moves Intervention Group
1214684|NCT00250497|O2|Outcome|Control Group|All Girls PE Control Group
1214685|NCT00250497|O1|Outcome|Intervention Group|New Moves Intervention Group
1214686|NCT00250497|O2|Outcome|Control Group|All Girls PE Control Group
1214687|NCT00250497|O1|Outcome|Intervention Group|New Moves Intervention Group
1214688|NCT00250497|O2|Outcome|Control Group|All Girls PE Control Group
1214689|NCT00250497|O1|Outcome|Intervention Group|New Moves Intervention Group
1214690|NCT00250497|E2|Reported Event|Control Group|All Girls PE Control Group
1214691|NCT00250497|E1|Reported Event|Intervention Group|New Moves Intervention Group
1214692|NCT00250484|B3|Baseline|Total|Total of all reporting groups
1214693|NCT00250484|B2|Baseline|Sham Transcranial Magnetic Stimulation|"Patients will receive no active TMS/treatment.~Sham Transcranial Magnetic Stimulation: Sham procedure of transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
1214694|NCT00250484|B1|Baseline|Transcranial Magnetic Stimulation|"Active treatment with TMS for 10 days.~Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
1214695|NCT00250484|P2|Participant Flow|Sham Transcranial Magnetic Stimulation|"Patients will receive no active TMS/treatment.~Sham Transcranial Magnetic Stimulation: Sham procedure of transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
1214696|NCT00250484|P1|Participant Flow|Transcranial Magnetic Stimulation|"Active treatment with TMS for 10 days.~Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
1214697|NCT00250484|O2|Outcome|Sham Transcranial Magnetic Stimulation|"Patients will receive no active TMS/treatment.~Sham Transcranial Magnetic Stimulation: Sham procedure of transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
1214765|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
1214701|NCT00250484|E2|Reported Event|Sham Transcranial Magnetic Stimulation|"Patients will receive no active TMS/treatment.~Sham Transcranial Magnetic Stimulation: Sham procedure of transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
1214702|NCT00250484|E1|Reported Event|Transcranial Magnetic Stimulation|"Active treatment with TMS for 10 days.~Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
1214703|NCT00250458|B3|Baseline|Total|Total of all reporting groups
1214704|NCT00250458|B2|Baseline|Placebo|Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack
1214705|NCT00250458|B1|Baseline|Rizatriptan 10 mg|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack
1214706|NCT00250458|P2|Participant Flow|Placebo|Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack
1214707|NCT00250458|P1|Participant Flow|Rizatriptan 10 mg|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack
1214708|NCT00250458|O2|Outcome|Placebo|Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack
1214709|NCT00250458|O1|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack
1214710|NCT00250458|O2|Outcome|Placebo|Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack
1214711|NCT00250458|O1|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack
1214712|NCT00250458|E2|Reported Event|Placebo|Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack
1214713|NCT00250458|E1|Reported Event|Rizatriptan 10 mg|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack
1214714|NCT00250432|B3|Baseline|Total|Total of all reporting groups
1214715|NCT00250432|B2|Baseline|Caspofungin 150 mg|Caspofungin 150 mg IV daily
1214719|NCT00250432|O2|Outcome|Caspofungin 150 mg|Caspofungin 150 mg IV daily
1214720|NCT00250432|O1|Outcome|Caspofungin 70/50 mg|Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)
1214721|NCT00250432|O2|Outcome|Caspofungin 150 mg|Caspofungin 150 mg IV daily
1214722|NCT00250432|O1|Outcome|Caspofungin 70/50 mg|Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)
1214723|NCT00250432|E2|Reported Event|Caspofungin 150 mg|Caspofungin 150 mg IV daily
1214724|NCT00250432|E1|Reported Event|Caspofungin 70/50 mg|Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)
1214725|NCT00249288|B3|Baseline|Total|Total of all reporting groups
1214726|NCT00249288|B2|Baseline|Folate|Patients underwent a 12 week trial of folate 2 mg/d
1214727|NCT00249288|B1|Baseline|Placebo|Participants received 2 mg/daily of placebo, for 12 weeks
1214728|NCT00249288|P2|Participant Flow|Placebo|
1214729|NCT00249288|P1|Participant Flow|Folate|Participants receiving 2 mg/daily of folate, for 12 weeks
1214730|NCT00249288|O2|Outcome|Placebo|"Participants will receive a 2 mg/ day dose of placebo, for 12 weeks~Placebo: Placebo taken by mouth daily as 2, 1mg capsule daily for 12 weeks"
1214731|NCT00249288|O1|Outcome|Folate|"Participants will receive a 2 mg/ day dose of folate, for 12 weeks~Folate: Folic acid taken as 2, 1mg capsule daily for 12 weeks"
1214732|NCT00249288|E2|Reported Event|Placebo|Participants receiving 2mg/daily of placebo, for 12 weeks
1214733|NCT00249288|E1|Reported Event|Folate|Participants receiving 2 mg/daily of folate, for 12 weeks
1214734|NCT00249249|B5|Baseline|Total|Total of all reporting groups
1214735|NCT00249249|B4|Baseline|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
1214736|NCT00249249|B3|Baseline|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
1214737|NCT00249249|B2|Baseline|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
1214738|NCT00249249|B1|Baseline|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
1214739|NCT00249249|P4|Participant Flow|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
1214740|NCT00249249|P3|Participant Flow|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
1214741|NCT00249249|P2|Participant Flow|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
1214742|NCT00249249|P1|Participant Flow|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
1214743|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
1214744|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
1214745|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
1214746|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
1214747|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
1214748|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
1214749|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
1214750|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
1214751|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
1214752|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
1214753|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
1214754|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
1214755|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
1214756|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
1214757|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
1214758|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
1214759|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
1214760|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
1214761|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
1214762|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
1214763|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
1214764|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
1214769|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
1214770|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
1214771|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
1214772|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
1214773|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
1214774|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
1214775|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
1214776|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
1214777|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
1214778|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
1214779|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
1214780|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
1214781|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
1214782|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
1214783|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
1214784|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
1214785|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
1214786|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
1214787|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
1214788|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
1214789|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
1214790|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
1214791|NCT00249249|E4|Reported Event|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
1214792|NCT00249249|E3|Reported Event|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
1214793|NCT00249249|E2|Reported Event|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
1214794|NCT00249249|E1|Reported Event|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
1214795|NCT00250276|B5|Baseline|Total|Total of all reporting groups
1214796|NCT00250276|B4|Baseline|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214797|NCT00250276|B3|Baseline|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214798|NCT00250276|B2|Baseline|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214799|NCT00250276|B1|Baseline|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214800|NCT00250276|P4|Participant Flow|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214801|NCT00250276|P3|Participant Flow|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214802|NCT00250276|P2|Participant Flow|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214803|NCT00250276|P1|Participant Flow|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214804|NCT00250276|O5|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214805|NCT00250276|O4|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
1214806|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214883|NCT00249873|P2|Participant Flow|Placebo + ASA|Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
1215064|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
1214807|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214808|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214809|NCT00250276|O5|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214810|NCT00250276|O4|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
1214811|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214812|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214894|NCT00249873|E1|Reported Event|Clopidogrel + ASA|Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
1214813|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214814|NCT00250276|O5|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214815|NCT00250276|O4|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
1214816|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214817|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214818|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214819|NCT00250276|O2|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured at lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214820|NCT00250276|O1|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
1214821|NCT00250276|O5|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214822|NCT00250276|O4|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
1214823|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214824|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214825|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1215191|NCT00247962|O1|Outcome|Etanercept|etanercept 50 mg once weekly
1214826|NCT00250276|O2|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured at lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214827|NCT00250276|O1|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
1214828|NCT00250276|O5|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214829|NCT00250276|O4|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
1214830|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214831|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214895|NCT00249821|B3|Baseline|Total|Total of all reporting groups
1216171|NCT00243659|O2|Outcome|Continuous Infusion|Approximately 50 IU/Kg Refacto AF then continuously
1214832|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214833|NCT00250276|O5|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214834|NCT00250276|O4|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
1214835|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214836|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214837|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214838|NCT00250276|O5|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214839|NCT00250276|O4|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
1214840|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214841|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214842|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214843|NCT00250276|O5|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214844|NCT00250276|O4|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
1214884|NCT00249873|P1|Participant Flow|Clopidogrel + ASA|Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
1215743|NCT00245102|B3|Baseline|Leiomyosarcoma|Sorafenib 400 mg PO BID
1214845|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214846|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214847|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214848|NCT00250276|O5|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214849|NCT00250276|O4|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
1214896|NCT00249821|B2|Baseline|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
1214850|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214851|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214852|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214853|NCT00250276|O5|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214854|NCT00250276|O4|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
1214855|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214856|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214857|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214858|NCT00250276|O4|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214859|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214860|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214861|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214862|NCT00250276|O4|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1215744|NCT00245102|B2|Baseline|MPNST|Sorafenib 400 mg PO BID
1214863|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214864|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214865|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214866|NCT00250276|O4|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214942|NCT00249613|P2|Participant Flow|Mixed-Gender Treatment 139 Subjects|Out-patient substance abuse treatment that included both women and men
1214867|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214868|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214869|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214870|NCT00250276|O5|Outcome|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214871|NCT00250276|O4|Outcome|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
1214872|NCT00250276|O3|Outcome|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214873|NCT00250276|O2|Outcome|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214874|NCT00250276|O1|Outcome|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214875|NCT00250276|E5|Reported Event|Cervarix Low Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214876|NCT00250276|E4|Reported Event|Pooled Group|The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.
1214877|NCT00250276|E3|Reported Event|Cervarix Lot3 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214878|NCT00250276|E2|Reported Event|Cervarix Lot2 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214879|NCT00250276|E1|Reported Event|Cervarix Lot1 Group|Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
1214880|NCT00249873|B3|Baseline|Total|Total of all reporting groups
1214881|NCT00249873|B2|Baseline|Placebo + ASA|Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
1214882|NCT00249873|B1|Baseline|Clopidogrel + ASA|Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
1214885|NCT00249873|O2|Outcome|Placebo + ASA|Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
1214886|NCT00249873|O1|Outcome|Clopidogrel + ASA|Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
1214887|NCT00249873|O2|Outcome|Placebo + ASA|Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
1214888|NCT00249873|O1|Outcome|Clopidogrel + ASA|Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
1214889|NCT00249873|O2|Outcome|Placebo + ASA|Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
1214890|NCT00249873|O1|Outcome|Clopidogrel + ASA|Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
1214891|NCT00249873|O2|Outcome|Placebo + ASA|Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
1214892|NCT00249873|O1|Outcome|Clopidogrel + ASA|Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
1214893|NCT00249873|E2|Reported Event|Placebo + ASA|Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
1217124|NCT00238121|B3|Baseline|Total|Total of all reporting groups
1214897|NCT00249821|B1|Baseline|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
1214898|NCT00249821|P2|Participant Flow|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
1214899|NCT00249821|P1|Participant Flow|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
1214900|NCT00249821|O2|Outcome|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
1214901|NCT00249821|O1|Outcome|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
1214902|NCT00249821|O2|Outcome|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
1214903|NCT00249821|O1|Outcome|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
1214904|NCT00249821|O2|Outcome|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
1214905|NCT00249821|O1|Outcome|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
1214906|NCT00249821|O2|Outcome|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
1214907|NCT00249821|O1|Outcome|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
1214908|NCT00249821|O2|Outcome|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
1214909|NCT00249821|O1|Outcome|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
1214910|NCT00249821|O2|Outcome|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
1214911|NCT00249821|O1|Outcome|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
1214912|NCT00249821|O2|Outcome|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
1214913|NCT00249821|O1|Outcome|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
1214914|NCT00249821|O2|Outcome|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
1214915|NCT00249821|O1|Outcome|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
1214916|NCT00249821|E2|Reported Event|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
1214917|NCT00249821|E1|Reported Event|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
1214918|NCT00249795|B3|Baseline|Total|Total of all reporting groups
1214919|NCT00249795|B2|Baseline|Placebo|matching placebo up to final follow-up visit
1214920|NCT00249795|B1|Baseline|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
1214921|NCT00249795|P2|Participant Flow|Placebo|matching placebo up to final follow-up visit
1214922|NCT00249795|P1|Participant Flow|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
1214923|NCT00249795|O2|Outcome|Placebo|matching placebo up to final follow-up visit
1214924|NCT00249795|O1|Outcome|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
1214925|NCT00249795|O2|Outcome|Placebo|matching placebo up to final follow-up visit
1214926|NCT00249795|O1|Outcome|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
1214927|NCT00249795|O2|Outcome|Placebo|matching placebo up to final follow-up visit
1214928|NCT00249795|O1|Outcome|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
1214929|NCT00249795|O2|Outcome|Placebo|matching placebo up to final follow-up visit
1214930|NCT00249795|O1|Outcome|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
1214931|NCT00249795|O2|Outcome|Placebo|matching placebo up to final follow-up visit
1214932|NCT00249795|O1|Outcome|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
1214933|NCT00249795|O2|Outcome|Placebo|matching placebo up to final follow-up visit
1214934|NCT00249795|O1|Outcome|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
1214935|NCT00249795|O2|Outcome|Placebo|matching placebo up to final follow-up visit
1214936|NCT00249795|O1|Outcome|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
1214937|NCT00249795|E2|Reported Event|Placebo|matching placebo up to final follow-up visit
1214938|NCT00249795|E1|Reported Event|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
1214939|NCT00249613|B3|Baseline|Total|Total of all reporting groups
1214940|NCT00249613|B2|Baseline|Mixed-Gender Treatment 139 Subjects|Out-patient substance abuse treatment for women and men
1214941|NCT00249613|B1|Baseline|Women-Only Treatment 152 Subjects|Out-patient gender-responsive substance abuse treatment for women only
1218932|NCT00227903|O1|Outcome|Brief Advice|Advice and education
1214943|NCT00249613|P1|Participant Flow|Women-Only Treatment 152 Subjects|Out patient gender-responsive substance abuse treatment for women only
1214944|NCT00249613|O1|Outcome|Group Status (Women-Only Compared to Mixed-Gender|Comparison of outcome in Women-Only vs. Mixed-Gender treatment
1214945|NCT00249613|O1|Outcome|Group Status (Women-Only Compared to Mixed-Gender)|Outpatient gender-responsive substance abuse treatment for women only vs. outpatient mixed-gender substance abuse treatment
1214946|NCT00249613|O1|Outcome|Women-Only Compared to Mixed-Gender|Outpatient gender-responsive substance abuse treatment for women only compared to outpatient substance abuse treatment for women and men
1214947|NCT00249613|O2|Outcome|Mixed-Gender|Substance abuse treatment program for both women and men
1214948|NCT00249613|O1|Outcome|Women-Only|"Substance abuse treatment program for women only~Women-Only: Gender-responsive treatment for women only"
1214949|NCT00249613|E2|Reported Event|Mixed-Gender|Outpatient mixed-gender substance abuse treatment
1214950|NCT00249613|E1|Reported Event|Women-Only|Outpatient gender-responsive substance abuse treatment for women only
1214951|NCT00249496|B3|Baseline|Total|Total of all reporting groups
1214952|NCT00249496|B2|Baseline|Contingency Management|"Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.~Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary."
1214953|NCT00249496|B1|Baseline|Employment Only|"Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.~Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work."
1214954|NCT00249496|P2|Participant Flow|Contingency Management|"Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.~Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary."
1214955|NCT00249496|P1|Participant Flow|Employment Only|"Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.~Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work."
1214956|NCT00249496|O2|Outcome|Contingency Management|"Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.~Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary."
1214957|NCT00249496|O1|Outcome|Employment Only|"Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.~Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work."
1214958|NCT00249496|E2|Reported Event|Contingency Management|"Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.~Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary."
1214959|NCT00249496|E1|Reported Event|Employment Only|"Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.~Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work."
1214960|NCT00249470|B3|Baseline|Total|Total of all reporting groups
1214987|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
1214988|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
1214961|NCT00249470|B2|Baseline|Work Only|"Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.~Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results."
1214962|NCT00249470|B1|Baseline|Abstinence & Work|"Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.~Abstinence & Work: Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour."
1214963|NCT00249470|P2|Participant Flow|Work Only|"Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.~Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results."
1214998|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
1216172|NCT00243659|O1|Outcome|Bolus Injection|Approximately 50 IU/kg Refacto AF for 6 consecutive days
1214964|NCT00249470|P1|Participant Flow|Abstinence & Work|"Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.~Abstinence & Work: Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour."
1214965|NCT00249470|O2|Outcome|Work Only|"Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.~Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results."
1214966|NCT00249470|O1|Outcome|Abstinence & Work|"Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.~Abstinence & Work: Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour."
1214967|NCT00249470|E2|Reported Event|Work Only|"Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.~Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results."
1214968|NCT00249470|E1|Reported Event|Abstinence & Work|"Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.~Abstinence & Work: Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour."
1214969|NCT00249379|B3|Baseline|Total|Total of all reporting groups
1214970|NCT00249379|B2|Baseline|Control|No specific intervention, monitored for outcomes
1214971|NCT00249379|B1|Baseline|Acamprosate|Criminal justice supervisees given acamprosate for alcohol dependence
1214972|NCT00249379|P2|Participant Flow|Control|No specific intervention, received standard Drug Court counseling, monitored for outcomes
1214973|NCT00249379|P1|Participant Flow|Acamprosate|Criminal justice supervisees given acamprosate 333 mg, 2 tablets orally 3 times daily for alcohol dependence for a 12-week period
1214974|NCT00249379|O2|Outcome|Control|
1214975|NCT00249379|O1|Outcome|Acamprosate|participants taking study medication
1214976|NCT00249379|O2|Outcome|Control|
1214977|NCT00249379|O1|Outcome|Acamprosate|participants taking study medication
1214978|NCT00249379|O2|Outcome|Control|
1214979|NCT00249379|O1|Outcome|Acamprosate|participants taking study medication
1214980|NCT00249379|O2|Outcome|Control|
1214981|NCT00249379|O1|Outcome|Acamprosate|participants taking study medication
1214982|NCT00249379|E2|Reported Event|Control|No specific intervention, monitored for outcomes
1214983|NCT00249379|E1|Reported Event|Acamprosate|Criminal justice supervisees given acamprosate for alcohol dependence
1214984|NCT00249002|B1|Baseline|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
1214985|NCT00249002|P1|Participant Flow|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
1214986|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
1214989|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
1214990|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
1214991|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
1214992|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
1214993|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
1214994|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
1214995|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
1214996|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
1214997|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
1214999|NCT00249002|E1|Reported Event|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
1215000|NCT00248807|B3|Baseline|Total|Total of all reporting groups
1215001|NCT00248807|B2|Baseline|Non-spinal Cord Injured Subjects|Non-spinal cord injured subjects underwent a 45 degree head-up tilt maneuver to lower blood pressure and monitor cerebral blood flow on 2 study visits. The first visit subject underwent the head-up tilt maneuver without drug and on the second visits subject underwent the head-up tilt maneuver following oral administration of an angiotensin converting enzyme inhibitor (ACE: 1.25 mg enalaprilat).
1215002|NCT00248807|B1|Baseline|Subjects With Spinal Cord Injury|Subjects with spinal cord injury underwent a 45 degree head-up tilt maneuver to lower blood pressure and monitor cerebral blood flow on 2 study visits. The first visit subject underwent the head-up tilt maneuver without drug and on the second visits subject underwent the head-up tilt maneuver following oral administration of an angiotensin converting enzyme inhibitor (ACE: 1.25 mg enalaprilat).
1215003|NCT00248807|P2|Participant Flow|Subjects Without SCI (Non-SCI)|Subjects without SCI (non-SCI) underwent a 45 degree head-up tilt maneuver to lower blood pressure and measure cerebral blood flow with and without enalaprilat (1.25 mg).
1215004|NCT00248807|P1|Participant Flow|Subjects With Spinal Cord Injury (SCI)|Subjects with SCI underwent a 45 degree head-up tilt maneuver to lower blood pressure and measure cerebral blood flow with and without enalaprilat (1.25 mg).
1215005|NCT00248807|O4|Outcome|ARM 4|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in able-bodied control subjects following intravenous administration of an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat).
1215006|NCT00248807|O3|Outcome|ARM 3|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in subjects with spinal cord injury following intravenous administration of an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat).
1215007|NCT00248807|O2|Outcome|ARM 2|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in able-bodied control subjects without drug.
1215008|NCT00248807|O1|Outcome|ARM 1|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in subjects with spinal cord injury without drug.
1215009|NCT00248807|O4|Outcome|ARM 4|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in able-bodied control subjects following intravenous administration of an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat).
1215010|NCT00248807|O3|Outcome|ARM 3|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in subjects with spinal cord injury following intravenous administration of an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat).
1215011|NCT00248807|O2|Outcome|ARM 2|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in able-bodied control subjects without drug
1215012|NCT00248807|O1|Outcome|ARM 1|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in subjects with spinal cord injury without drug
1215013|NCT00248807|E4|Reported Event|ARM 4|1.25 mg enalaprilat IV and 45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in able-bodied controls.
1215014|NCT00248807|E3|Reported Event|ARM 3|1.25 mg enalaprilat IV and 45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in subjects with spinal cord injury.
1215015|NCT00248807|E2|Reported Event|ARM 2|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in able-bodied controls.
1215016|NCT00248807|E1|Reported Event|ARM 1|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in subjects with spinal cord injury.
1215017|NCT00248794|B4|Baseline|Total|Total of all reporting groups
1215018|NCT00248794|B3|Baseline|Skills Group Only|Participants receive upto 5 hours of generic staff contact and weekly skills training group for 15 weeks
1215019|NCT00248794|B2|Baseline|ICBCR + Skills Group|Participants receive upto 5 hours of ICBCR and weekly skills training group for 15 weeks
1215020|NCT00248794|B1|Baseline|CRT +Skills Group|Participants receive upto 5 hours of CRT and weekly skills training group for 15 weeks
1215021|NCT00248794|P3|Participant Flow|Skills Group Control|Participants received weekly skills group + up to five individual contacts with research staff without active cognitive training
1215022|NCT00248794|P2|Participant Flow|ICBCR and Skills Training|"Individualized Computer Based Cognitive Remediation~Participants received up to 5 hours of ICBRC and weekly skills group"
1215063|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
1215023|NCT00248794|P1|Participant Flow|CRT + Skills Training|"Cognitive Remediation therapy+ skills training~Participants received up to 5 hours of CRT and weekly skills training group"
1215024|NCT00248794|O3|Outcome|Skills Group Control|Life skills group + up to five individual contacts with research staff without active cognitive training
1215025|NCT00248794|O2|Outcome|ICBCR and Skills Training|"Individualized Computer Based Cognitive Remediation-Up to 5 hours of of computer based cognitive remediation (ICBCR). All subjects randomized to this condition also are receiving the weekly skills group.~Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
1215026|NCT00248794|O1|Outcome|CRT + Skills Training|"Cognitive Remediation therapy-Up to 5 hours of one on one cognitive remediation using CRT. All subjects randomized to this condition also are receiving the weekly skills group.~Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
1215027|NCT00248794|O3|Outcome|Skills Group Control|Participants receive upto 5 hours of generic staff contact and weekly skills training group for 15 weeks
1215028|NCT00248794|O2|Outcome|ICBCR and Skills Training|Participants receive upto 5 hours of ICBCR and weekly skills training group for 15 weeks
1215029|NCT00248794|O1|Outcome|CRT + Skills Training|Participants receive upto 5 hours of CRT and weekly skills training group for 15 weeks
1215030|NCT00248794|O3|Outcome|Skills Group Control|Participants received weekly skills group + up to five individual contacts with research staff without active cognitive training
1215031|NCT00248794|O2|Outcome|ICBCR and Skills Training|"Individualized Computer Based Cognitive Remediation~Participants received up to 5 hours of ICBRC and weekly skills group"
1215237|NCT00247611|O4|Outcome|Intervention (On Protocol)|152 (55%) of the ITT included intervention arm participants
1215032|NCT00248794|O1|Outcome|CRT + Skills Training|"Cognitive Remediation therapy+ skills training~Participants received up to 5 hours of CRT and weekly skills training group"
1215033|NCT00248794|O3|Outcome|Skills Group Control|Life skills group + up to five individual contacts with research staff without active cognitive training
1215034|NCT00248794|O2|Outcome|ICBCR and Skills Training|"Individualized Computer Based Cognitive Remediation-Up to 5 hours of of computer based cognitive remediation (ICBCR). All subjects randomized to this condition also are receiving the weekly skills group.~Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
1215035|NCT00248794|O1|Outcome|CRT + Skills Training|"Cognitive Remediation therapy-Up to 5 hours of one on one cognitive remediation using CRT. All subjects randomized to this condition also are receiving the weekly skills group.~Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
1215036|NCT00248794|O3|Outcome|Skills Group Control|Life skills group + up to five individual contacts with research staff without active cognitive training
1215037|NCT00248794|O2|Outcome|ICBCR and Skills Training|"Individualized Computer Based Cognitive Remediation-Up to 5 hours of of computer based cognitive remediation (ICBCR). All subjects randomized to this condition also are receiving the weekly skills group.~Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
1215038|NCT00248794|O1|Outcome|CRT + Skills Training|"Cognitive Remediation therapy-Up to 5 hours of one on one cognitive remediation using CRT. All subjects randomized to this condition also are receiving the weekly skills group.~Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
1215039|NCT00248794|E3|Reported Event|Skills Group + Generic Contact|Life skills group + up to five individual contacts with research staff without active cognitive training
1215040|NCT00248794|E2|Reported Event|ICBCR + Skills Group|"Individualized Computer Based Cognitive Remediation-Up to 5 hours of of computer based cognitive remediation (ICBCR). All subjects randomized to this condition also are receiving the weekly skills group.~Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
1215041|NCT00248794|E1|Reported Event|CRT+Skills Group|"Cognitive Remediation therapy-Up to 5 hours of one on one cognitive remediation using CRT. All subjects randomized to this condition also are receiving the weekly skills group.~Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
1215042|NCT00248781|B3|Baseline|Total|Total of all reporting groups
1215043|NCT00248781|B2|Baseline|Arm 2|attention control (health education)
1215044|NCT00248781|B1|Baseline|Arm 1|Telecommunications system for exercise
1215045|NCT00248781|P2|Participant Flow|Attention Control Group|attention control (health education)
1215046|NCT00248781|P1|Participant Flow|Automated Exercise Group|Telecommunications system for exercise
1215047|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
1215048|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
1215049|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
1215050|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
1215051|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
1215052|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
1215053|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
1215054|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
1215055|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
1215056|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
1215057|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
1215058|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
1215059|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
1215060|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
1215061|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
1215062|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
1215065|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
1215066|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
1215067|NCT00248781|E2|Reported Event|Attention Control Group|attention control (health education)
1215068|NCT00248781|E1|Reported Event|Automated Exercise Group|Telecommunications system for exercise
1215069|NCT00248651|B4|Baseline|Total|Total of all reporting groups
1215070|NCT00248651|B3|Baseline|Placebo|Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
1215071|NCT00248651|B2|Baseline|Escitalopram|Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
1215072|NCT00248651|B1|Baseline|Amitriptyline|Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
1215073|NCT00248651|P3|Participant Flow|Placebo|Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
1215074|NCT00248651|P2|Participant Flow|Escitalopram|Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
1215199|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
1219016|NCT00227344|E1|Reported Event|Catheter Ablation|Catheter Ablation
1215075|NCT00248651|P1|Participant Flow|Amitriptyline|Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
1215076|NCT00248651|O3|Outcome|Placebo|Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
1215077|NCT00248651|O2|Outcome|Escitalopram|Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
1215078|NCT00248651|O1|Outcome|Amitriptyline|Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
1215079|NCT00248651|O3|Outcome|Placebo|Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
1215080|NCT00248651|O2|Outcome|Escitalopram|Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
1215081|NCT00248651|O1|Outcome|Amitriptyline|Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
1215082|NCT00248651|O3|Outcome|Placebo|Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
1215083|NCT00248651|O2|Outcome|Escitalopram|Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
1215084|NCT00248651|O1|Outcome|Amitriptyline|Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
1215085|NCT00248651|O3|Outcome|Placebo|Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
1215086|NCT00248651|O2|Outcome|Escitalopram|Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
1215087|NCT00248651|O1|Outcome|Amitriptyline|Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
1215088|NCT00248651|E3|Reported Event|Placebo|Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
1215089|NCT00248651|E2|Reported Event|Escitalopram|Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
1215090|NCT00248651|E1|Reported Event|Amitriptyline|Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
1215091|NCT00248638|B3|Baseline|Total|Total of all reporting groups
1215092|NCT00248638|B2|Baseline|Standard|Participants given standard nutrition without glutamine dipeptide
1215093|NCT00248638|B1|Baseline|Glutamine Dipeptide|Glutamine dipeptide supplemented nutrition to be given to participants.
1215094|NCT00248638|P2|Participant Flow|Standard|Participants given standard nutrition without glutamine dipeptide
1215095|NCT00248638|P1|Participant Flow|Glutamine Dipeptide|Glutamine dipeptide supplemented nutrition to be given to participants.
1215096|NCT00248638|O2|Outcome|Standard|"Participants given standard nutrition without glutamine dipeptide~Glutamine dipeptide: Subjects randomized to AG-PN will receive PN containing 0.5 g/kg/day of L alanyl L GLN (AG) dipeptide (Dipeptiven 20%; Fresenius-Kabi) and 1.0 g/kg/day of 15% Clinisol (Baxter Inc., Deerfield, IL) AA solution (total = 1.5 g/kg/day, with AG replacing 1/3 of Clinisol AA). Subjects randomized to STD-PN will receive PN AA as the standard, GLN-free amino acid solution (15% Clinisol). The AA solutions are nearly isonitrogenous; STD-PN provides 2.35 g nitrogen and the AG-PN provides 2.45 g nitrogen per 100 ml 15% AA solution. The amount of GLN dipeptide administered each day will be determined by daily PN volume intake data.~Study subjects will receive a maximum of 28 days of study PN (blinded placebo or GLN-dipeptide-supplemented PN). If the subject continues to require PN after Day 28, study PN and GLN dipeptide will be discontinued."
1215097|NCT00248638|O1|Outcome|Glutamine Dipeptide|"Glutamine dipeptide supplemented nutrition to be given to participants.~Glutamine dipeptide: Subjects randomized to AG-PN will receive PN containing 0.5 g/kg/day of L alanyl L GLN (AG) dipeptide (Dipeptiven 20%; Fresenius-Kabi) and 1.0 g/kg/day of 15% Clinisol (Baxter Inc., Deerfield, IL) AA solution (total = 1.5 g/kg/day, with AG replacing 1/3 of Clinisol AA). Subjects randomized to STD-PN will receive PN AA as the standard, GLN-free amino acid solution (15% Clinisol). The AA solutions are nearly isonitrogenous; STD-PN provides 2.35 g nitrogen and the AG-PN provides 2.45 g nitrogen per 100 ml 15% AA solution. The amount of GLN dipeptide administered each day will be determined by daily PN volume intake data.~Study subjects will receive a maximum of 28 days of study PN (blinded placebo or GLN-dipeptide-supplemented PN). If the subject continues to require PN after Day 28, study PN and GLN dipeptide will be discontinued."
1215098|NCT00248638|O2|Outcome|Standard|Participants given standard nutrition without glutamine dipeptide
1215099|NCT00248638|O1|Outcome|Glutamine Dipeptide|Glutamine dipeptide supplemented nutrition to be given to participants.
1215100|NCT00248638|E2|Reported Event|Standard|Participants given standard nutrition without glutamine dipeptide
1215101|NCT00248638|E1|Reported Event|Glutamine Dipeptide|Glutamine dipeptide supplemented nutrition to be given to participants.
1215102|NCT00248625|B3|Baseline|Total|Total of all reporting groups
1215238|NCT00247611|O3|Outcome|Control (On Protocol Sample)|176 (61%) of the ITT included control arm participants
1215103|NCT00248625|B2|Baseline|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive~Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
1215104|NCT00248625|B1|Baseline|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
1215105|NCT00248625|P2|Participant Flow|N-acetylcysteine (NAC)|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) and water. Volumes were adjusted for small children. Study medications were infused over 24 hours for up to 7 consecutive days in a dedicated line without other medications. Treatment was stopped earlier than 7 days in the case of hospital discharge, LTx, or death within 7 days of randomization.~N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study. The infusion is discontinued at the time of death, liver transplant or discharge."
1215106|NCT00248625|P1|Participant Flow|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to placebo consisting of D5W alone. Volumes were adjusted for small children. Study medications were infused over 24 hours for up to 7 consecutive days in a dedicated line without other medications. Treatment was stopped earlier than 7 days in the case of hospital discharge, liver transplantation, or death within 7 days of randomization.~Dextrose in water: Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive N-acetylcysteine (150 mg/kg/d) in 5% dextrose (D5W) and water or placebo consisting of an equal volume of D5W alone. Volumes were adjusted for small children. Study medications were infused over 24 hours for up to 7 consecutive days in a dedicated line without other medications."
1215107|NCT00248625|O2|Outcome|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive~Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
1215108|NCT00248625|O1|Outcome|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
1215109|NCT00248625|O2|Outcome|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive~Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
1215110|NCT00248625|O1|Outcome|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
1215111|NCT00248625|O2|Outcome|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive~Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
1215112|NCT00248625|O1|Outcome|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
1215113|NCT00248625|O2|Outcome|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive~Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
1215114|NCT00248625|O1|Outcome|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
1215188|NCT00247962|P2|Participant Flow|Sulphasalazine|Sulphasalazine (SSZ) titration up to 3 g daily
1215745|NCT00245102|B1|Baseline|Angiosarcoma|Sorafenib 400 mg PO BID
1215115|NCT00248625|O2|Outcome|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive~Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
1215116|NCT00248625|O1|Outcome|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
1215117|NCT00248625|O2|Outcome|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive~Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
1215200|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
1219411|NCT00224016|B2|Baseline|Oral Oxybutynin|Oxybutynin tablets
1215118|NCT00248625|O1|Outcome|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
1215119|NCT00248625|O2|Outcome|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive~Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
1215120|NCT00248625|O1|Outcome|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
1215121|NCT00248625|O2|Outcome|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive~Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
1215122|NCT00248625|O1|Outcome|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
1215123|NCT00248625|E2|Reported Event|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive~Dextrose in water: Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) and water or placebo consisting of an equal volume of D5W alone. Volumes were adjusted for small children. Study medications were infused over 24 hours for up to 7 consecutive days in a dedicated line without other medications. Treatment was stopped earlier than 7 days in the case of hospital discharge, LTx, or death within 7 days of randomization."
1215124|NCT00248625|E1|Reported Event|N-acetylcysteine (NAC)|"Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days~N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study. The infusion is discontinued at the time of death, liver transplant or discharge."
1215125|NCT00248560|B1|Baseline|Gemcitabine, Docetaxel|"docetaxel~gemcitabine hydrochloride"
1215126|NCT00248560|P1|Participant Flow|Gemcitabine, Docetaxel|"docetaxel~gemcitabine hydrochloride"
1215127|NCT00248560|O1|Outcome|Gemcitabine Hydrochloride, Docetaxel|Gemcitabine hydrochloride given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine hydrochloride.
1215128|NCT00248560|E1|Reported Event|Gemcitabine, Docetaxel|"docetaxel~gemcitabine hydrochloride"
1215129|NCT00248547|B3|Baseline|Total|Total of all reporting groups
1215130|NCT00248547|B2|Baseline|Placebo|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
1215131|NCT00248547|B1|Baseline|Aprepitant|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
1215132|NCT00248547|P2|Participant Flow|Placebo|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
1215133|NCT00248547|P1|Participant Flow|Aprepitant|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
1215134|NCT00248547|O2|Outcome|Placebo (Sugar Pill)|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
1215135|NCT00248547|O1|Outcome|Aprepitant|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
1215136|NCT00248547|E2|Reported Event|Placebo|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
1215137|NCT00248547|E1|Reported Event|Aprepitant|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
1215138|NCT00248495|B1|Baseline|Neoadjuvant Chemotherapy|"Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses~cisplatin: Given IV~pemetrexed disodium: Given IV~adjuvant therapy: Metastasis prevention/control~conventional surgery: Undergoing tissue removal~neoadjuvant therapy: Tumor Reduction"
1215189|NCT00247962|P1|Participant Flow|Etanercept|etanercept 50 mg once weekly
1215190|NCT00247962|O2|Outcome|Sulphasalazine|Sulphasalazine (SSZ) titration up to 3 g daily
1215139|NCT00248495|P1|Participant Flow|Neoadjuvant Chemotherapy|"Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses~cisplatin: Given IV~pemetrexed disodium: Given IV~adjuvant therapy: Metastasis prevention/control~conventional surgery: Undergoing tissue removal~neoadjuvant therapy: Tumor Reduction"
1215140|NCT00248495|O1|Outcome|Neoadjuvant Chemotherapy|"Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses~cisplatin: Given IV~pemetrexed disodium: Given IV~adjuvant therapy: Metastasis prevention/control~conventional surgery: Undergoing tissue removal~neoadjuvant therapy: Tumor Reduction"
1215141|NCT00248495|O1|Outcome|Neoadjuvant Chemotherapy|"Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses~cisplatin: Given IV~pemetrexed disodium: Given IV~adjuvant therapy: Metastasis prevention/control~conventional surgery: Undergoing tissue removal~neoadjuvant therapy: Tumor Reduction"
1215142|NCT00248495|O1|Outcome|Neoadjuvant Chemotherapy|"Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses~cisplatin: Given IV~pemetrexed disodium: Given IV~adjuvant therapy: Metastasis prevention/control~conventional surgery: Undergoing tissue removal~neoadjuvant therapy: Tumor Reduction"
1215143|NCT00248495|O1|Outcome|Neoadjuvant Chemotherapy|"Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses~cisplatin: Given IV~pemetrexed disodium: Given IV~adjuvant therapy: Metastasis prevention/control~conventional surgery: Undergoing tissue removal~neoadjuvant therapy: Tumor Reduction"
1215144|NCT00248495|O1|Outcome|Neoadjuvant Chemotherapy|"Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses~cisplatin: Given IV~pemetrexed disodium: Given IV~adjuvant therapy: Metastasis prevention/control~conventional surgery: Undergoing tissue removal~neoadjuvant therapy: Tumor Reduction"
1215145|NCT00248495|O1|Outcome|Neoadjuvant Chemotherapy|"Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses~cisplatin: Given IV~pemetrexed disodium: Given IV~adjuvant therapy: Metastasis prevention/control~conventional surgery: Undergoing tissue removal~neoadjuvant therapy: Tumor Reduction"
1215146|NCT00248495|E1|Reported Event|Neoadjuvant Chemotherapy|"Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses~cisplatin: Given IV~pemetrexed disodium: Given IV~adjuvant therapy: Metastasis prevention/control~conventional surgery: Undergoing tissue removal~neoadjuvant therapy: Tumor Reduction"
1215147|NCT00248287|B3|Baseline|Total|Total of all reporting groups
1215148|NCT00248287|B2|Baseline|Irinotecan+Carboplatin+Cetuximab|Patients treated with Irinotecan + Carboplatin + Cetuximab
1215149|NCT00248287|B1|Baseline|Irinotecan+Carboplatin|Patients treated with Irinotecan + Carboplatin
1215150|NCT00248287|P2|Participant Flow|Irinotecan+Carboplatin+Cetuximab|Patients treated with Irinotecan + Carboplatin + Cetuximab
1215151|NCT00248287|P1|Participant Flow|Irinotecan+Carboplatin|Patients treated with Irinotecan + Carboplatin
1215152|NCT00248287|O2|Outcome|Irinotecan+Carboplatin+Cetuximab|Patients treated with Irinotecan + Carboplatin + Cetuximab
1215153|NCT00248287|O1|Outcome|Irinotecan+Carboplatin|Patients treated with Irinotecan + Carboplatin
1215154|NCT00248287|O2|Outcome|Irinotecan+Carboplatin+Cetuximab|Patients treated with Irinotecan + Carboplatin + Cetuximab
1215155|NCT00248287|O1|Outcome|Irinotecan+Carboplatin|Patients treated with Irinotecan + Carboplatin
1215156|NCT00248287|O2|Outcome|Irinotecan+Carboplatin+Cetuximab|Patients treated with Irinotecan + Carboplatin + Cetuximab
1215157|NCT00248287|O1|Outcome|Irinotecan+Carboplatin|Patients treated with Irinotecan + Carboplatin
1215158|NCT00248287|O2|Outcome|Irinotecan+Carboplatin+Cetuximab|Patients treated with Irinotecan + Carboplatin + Cetuximab
1215159|NCT00248287|O1|Outcome|Irinotecan+Carboplatin|Patients treated with Irinotecan + Carboplatin
1215160|NCT00248287|E2|Reported Event|Irinotecan+Carboplatin+Cetuximab|Patients treated with Irinotecan + Carboplatin + Cetuximab
1215161|NCT00248287|E1|Reported Event|Irinotecan+Carboplatin|Patients treated with Irinotecan + Carboplatin
1215162|NCT00248170|B3|Baseline|Total|Total of all reporting groups
1215163|NCT00248170|B2|Baseline|Anastrozole|1 mg p.o. once daily
1215164|NCT00248170|B1|Baseline|Letrozole|2.5 mg by mouth (p.o.) once daily
1215165|NCT00248170|P2|Participant Flow|Anastrozole|1 mg p.o. once daily
1215166|NCT00248170|P1|Participant Flow|Letrozole|2.5 mg by mouth (p.o.) once daily
1215167|NCT00248170|O2|Outcome|Anastrozole|1 mg p.o. once daily
1215168|NCT00248170|O1|Outcome|Letrozole|2.5 mg by mouth (p.o.) once daily
1215169|NCT00248170|O2|Outcome|Anastrozole|1 mg p.o. once daily
1215170|NCT00248170|O1|Outcome|Letrozole|2.5 mg by mouth (p.o.) once daily
1215171|NCT00248170|O2|Outcome|Anastrozole|1 mg p.o. once daily
1215172|NCT00248170|O1|Outcome|Letrozole|2.5 mg by mouth (p.o.) once daily
1215173|NCT00248170|O2|Outcome|Anastrozole|1 mg p.o. once daily
1215174|NCT00248170|O1|Outcome|Letrozole|2.5 mg by mouth (p.o.) once daily
1215175|NCT00248170|O2|Outcome|Anastrozole|1 mg p.o. once daily
1215176|NCT00248170|O1|Outcome|Letrozole|2.5 mg by mouth (p.o.) once daily
1215177|NCT00248170|O2|Outcome|Anastrozole|1 mg p.o. once daily
1215178|NCT00248170|O1|Outcome|Letrozole|2.5 mg by mouth (p.o.) once daily
1215179|NCT00248170|O2|Outcome|Anastrozole|1 mg p.o. once daily
1215180|NCT00248170|O1|Outcome|Letrozole|2.5 mg by mouth (p.o.) once daily
1215181|NCT00248170|O2|Outcome|Anastrozole|1 mg p.o. once daily
1215182|NCT00248170|O1|Outcome|Letrozole|2.5 mg by mouth (p.o.) once daily
1215183|NCT00248170|E2|Reported Event|Anastrozole|Anastrozole
1215184|NCT00248170|E1|Reported Event|Letrozole|Letrozole
1215185|NCT00247962|B3|Baseline|Total|Total of all reporting groups
1215186|NCT00247962|B2|Baseline|Sulphasalazine|Sulphasalazine (SSZ) titration up to 3 g daily
1215187|NCT00247962|B1|Baseline|Etanercept|etanercept 50 mg once weekly
1215192|NCT00247962|O2|Outcome|Sulphasalazine|Sulphasalazine (SSZ) titration up to 3 g daily
1215193|NCT00247962|O1|Outcome|Etanercept|etanercept 50 mg once weekly
1215194|NCT00247962|E2|Reported Event|Sulphasalazine|Sulphasalazine (SSZ) titration up to 3 g daily
1215195|NCT00247962|E1|Reported Event|Etanercept|etanercept 50 mg once weekly
1215196|NCT00247676|B1|Baseline|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
1215197|NCT00247676|P1|Participant Flow|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
1215198|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
1219413|NCT00224016|P2|Participant Flow|Oral Oxybutynin|Oxybutynin tablets
1215201|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
1215202|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
1215203|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
1215204|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
1215205|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
1215206|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
1215207|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
1215208|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
1215209|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
1215210|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
1215211|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
1215212|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
1215213|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
1215214|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
1215215|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
1215216|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
1215217|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
1215218|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
1215219|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
1215220|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
1215221|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
1215222|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
1215223|NCT00247676|E1|Reported Event|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
1215224|NCT00247611|B3|Baseline|Total|Total of all reporting groups
1217790|NCT00235443|O7|Outcome|Total|All modal dose groups combined
1215225|NCT00247611|B2|Baseline|Intervention|Participants will receive the LifeWindows Intervention sessions
1215226|NCT00247611|B1|Baseline|Control|Participants will receive the control condition
1215227|NCT00247611|P2|Participant Flow|Intervention|Participants will receive the LifeWindows Intervention sessions
1215228|NCT00247611|P1|Participant Flow|Control|Participants will receive the control condition
1215229|NCT00247611|O2|Outcome|Total Excluded From OP Sample|ITT sample excluded from the post-hoc analysis of the participants provided >=6 assessments with no ART receipt interruptions (ITT - OP sample)
1215230|NCT00247611|O1|Outcome|On Protocol (OP) Sample|Post-hoc analysis of the participants provided >=6 assessments with no ART receipt interruptions
1215231|NCT00247611|O4|Outcome|Intervention (On Protocol Sample)|152 (55%) of the ITT included intervention arm participants
1215232|NCT00247611|O3|Outcome|Control (On Protocol Sample)|176 (61%) of the ITT included control arm participants
1215233|NCT00247611|O2|Outcome|Intervention (ITT Sample)|277 (96%) of the 290 randomized to Intervention condition
1215234|NCT00247611|O1|Outcome|Control (ITT Sample)|287 (94%) of the 304 randomized to control
1215235|NCT00247611|O2|Outcome|Intervention (ITT Sample)|277 (96%) of the 290 randomized to Intervention condition
1215236|NCT00247611|O1|Outcome|Control (ITT Sample)|287 (94%) of the 304 randomized to control
1215239|NCT00247611|O2|Outcome|Intervention (ITT Sample)|277 (96%) of the 290 randomized to Intervention condition
1215240|NCT00247611|O1|Outcome|Control (ITT Sample %)|287 (94%) of the 304 randomized to control
1215241|NCT00247611|E2|Reported Event|Intervention|Participants will receive the LifeWindows Intervention sessions
1215242|NCT00247611|E1|Reported Event|Control|Participants will receive the control condition
1215243|NCT00247416|B3|Baseline|Total|Total of all reporting groups
1215244|NCT00247416|B2|Baseline|Arm 2, Dexamethasone Pretreatment Test Arm|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8).
1215245|NCT00247416|B1|Baseline|Arm 1, Control, no Dexamethasone Pretreatment|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment.
1215246|NCT00247416|P2|Participant Flow|Arm 2, Dexamethasone Pretreatment Test Arm|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8).
1215247|NCT00247416|P1|Participant Flow|Arm 1, Control, no Dexamethasone Pretreatment|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment.
1215248|NCT00247416|O2|Outcome|Arm 2, Dexamethasone Pretreatment Test Arm|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8).
1215249|NCT00247416|O1|Outcome|Arm 1, Control, no Dexamethasone Pretreatment|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment.
1215250|NCT00247416|O2|Outcome|Arm 2, Dexamethasone Pretreatment Test Arm|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8).
1215251|NCT00247416|O1|Outcome|Arm 1, Control, no Dexamethasone Pretreatment|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment.
1215252|NCT00247416|O2|Outcome|Arm 2, Dexamethasone Pretreatment Test Arm|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8).
1215253|NCT00247416|O1|Outcome|Arm 1, Control, no Dexamethasone Pretreatment|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment.
1215254|NCT00247416|O2|Outcome|2 Dex|"Dexamethasone~Gemcitabine: Gemcitabine 1000 mg/m^2 intravenously over 30 minutes on days 5 and 12.~Dexamethasone: 16 mg bid for 4 days prior to each chemotherapy start.~Carboplatin: AUC 6.0 intravenously over 30 minutes on day 5."
1215255|NCT00247416|O1|Outcome|1 No Dex|"No Dexamethasone~Gemcitabine: Gemcitabine 1000 mg/m^2 intravenously over 30 minutes on days 5 and 12.~Carboplatin: AUC 6.0 intravenously over 30 minutes on day 5."
1215256|NCT00247416|E2|Reported Event|2 Dexamethasone|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8).
1215257|NCT00247416|E1|Reported Event|1 No Dexamethasone|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment.
1215258|NCT00247377|B3|Baseline|Total|Total of all reporting groups
1215259|NCT00247377|B2|Baseline|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
1215260|NCT00247377|B1|Baseline|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
1215261|NCT00247377|P2|Participant Flow|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
1215262|NCT00247377|P1|Participant Flow|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
1215263|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
1215264|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
1215265|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
1215266|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
1215267|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
1215268|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
1215269|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
1215270|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
1215271|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
1215272|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
1215273|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
1215274|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
1215275|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
1215276|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
1215277|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
1215278|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
1215279|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
1215280|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
1215281|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
1215282|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
1215283|NCT00247377|E2|Reported Event|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
1215284|NCT00247377|E1|Reported Event|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
1215285|NCT00247273|B3|Baseline|Total|Total of all reporting groups
1215286|NCT00247273|B2|Baseline|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
1215287|NCT00247273|B1|Baseline|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
1215288|NCT00247273|P2|Participant Flow|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
1215289|NCT00247273|P1|Participant Flow|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
1215290|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
1215291|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
1215292|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
1215293|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
1215294|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
1215295|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
1215296|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
1215297|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
1215298|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
1215299|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
1215300|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
1215301|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
1215302|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
1215303|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
1215304|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
1215305|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
1215306|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
1215307|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
1215308|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
1215309|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
1215310|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
1215311|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
1215312|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
1215313|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
1215314|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
1215315|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
1215316|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
1215317|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
1215318|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
1215319|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
1215320|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
1215321|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
1215322|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
1215323|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
1215324|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
1215325|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
1215326|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
1215327|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
1215328|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
1215329|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
1215330|NCT00247273|E2|Reported Event|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
1215331|NCT00247273|E1|Reported Event|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
1215332|NCT00246805|B3|Baseline|Total|Total of all reporting groups
1215333|NCT00246805|B2|Baseline|VRS OFF|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
1215334|NCT00246805|B1|Baseline|VRS ON|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
1215335|NCT00246805|P2|Participant Flow|VRS OFF|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
1215336|NCT00246805|P1|Participant Flow|VRS ON|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
1215337|NCT00246805|O2|Outcome|VRS OFF|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
1215338|NCT00246805|O1|Outcome|VRS ON|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
1215339|NCT00246805|E2|Reported Event|VRS OFF|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
1215340|NCT00246805|E1|Reported Event|VRS ON|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
1215341|NCT00246571|B3|Baseline|Total|Total of all reporting groups
1215342|NCT00246571|B2|Baseline|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
1215343|NCT00246571|B1|Baseline|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
1215344|NCT00246571|P2|Participant Flow|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 milligrams per square meter (mg/m^2) twice daily (BID) Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid intravenous (IV) infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If Response Evaluation Criteria in Solid Tumors (RECIST) defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
1215345|NCT00246571|P1|Participant Flow|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
1215346|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
1215347|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
1215348|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
1215349|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
1215350|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
1215351|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
1215367|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
1216511|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
1215352|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
1215353|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
1215354|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
1215355|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
1215356|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
1215357|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
1215358|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
1215359|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
1215360|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
1215361|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
1215362|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
1215363|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
1215415|NCT00246376|O2|Outcome|Group 2 - Diet/Exercise Only|These subjects participated in the diet/exercise program and took placebos.
1215416|NCT00246376|O1|Outcome|Group 1 - Usual Care|These subjects did not participate in the diet/exercise program and took placebos.
1215364|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
1215365|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
1215366|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
1215368|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
1215369|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
1215370|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
1215371|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
1215372|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
1215373|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
1215374|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
1215375|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
1215376|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
1215377|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
1215417|NCT00246376|O5|Outcome|Group 5 - Diet/Exercise + Fenofibrate + Niacin|These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
1215595|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
1215378|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
1215379|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
1215427|NCT00246376|O5|Outcome|Group 5 - Diet/Exercise + Fenofibrate + Niacin|
1215428|NCT00246376|O4|Outcome|Group 4 - Diet/Exercise + Niacin|
1215429|NCT00246376|O3|Outcome|Group 3 - Diet/Exercise + Fenofibrate|
1215430|NCT00246376|O2|Outcome|Group 2 - Diet/Exercise Only|
1215431|NCT00246376|O1|Outcome|Group 1 - Usual Care|
1215432|NCT00246376|O5|Outcome|Group 5 - Diet/Exercise + Fenofibrate + Niacin|These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
1222331|NCT00198822|B4|Baseline|Total|Total of all reporting groups
1215380|NCT00246571|E2|Reported Event|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 milligrams per square meter (mg/m^2) twice daily (BID) Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid intravenous (IV) infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If Response Evaluation Criteria in Solid Tumors (RECIST) defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
1215381|NCT00246571|E1|Reported Event|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
1215382|NCT00246519|B3|Baseline|Total|Total of all reporting groups
1215383|NCT00246519|B2|Baseline|HCTZ + Atenolol|HCTZ 12.5 mg then HCTZ 25 mg if BP < 120/70, then add atenolol 50 mg if BP < 120/70, then atenolol 100 mg if BP < 120/70.
1215384|NCT00246519|B1|Baseline|Atenolol +HCTZ Arm|atenolol 50 mg, then 100 mg if BP < 120/70, then add HCTZ 12.5 mg if BP < 120/70, then HCTZ 25 mg if BP < 120/70
1215385|NCT00246519|P2|Participant Flow|Hydrochlorothiazide (HCTZ) + Atenolol|HCTZ 12.5 mg then HCTZ 25 mg if BP < 120/70, then add atenolol 50 mg if BP < 120/70, then atenolol 100 mg if BP < 120/70.
1215386|NCT00246519|P1|Participant Flow|Atenolol + Hydroclorothiazide (HCTZ) Arm|atenolol 50 mg, then 100 mg if BP < 120/70, then add HCTZ 12.5 mg if BP < 120/70, then HCTZ 25 mg if BP < 120/70
1215387|NCT00246519|O2|Outcome|HCTZ + Atenolol|HCTZ 12.5 mg then HCTZ 25 mg if BP < 120/70, then add atenolol 50 mg if BP < 120/70, then atenolol 100 mg if BP < 120/70.
1215388|NCT00246519|O1|Outcome|Atenolol +HCTZ Arm|atenolol 50 mg, then 100 mg if BP < 120/70, then add HCTZ 12.5 mg if BP < 120/70, then HCTZ 25 mg if BP < 120/70
1215389|NCT00246519|E2|Reported Event|HCTZ + Atenolol|HCTZ 12.5 mg then HCTZ 25 mg if BP < 120/70, then add atenolol 50 mg if BP < 120/70, then atenolol 100 mg if BP < 120/70.
1215390|NCT00246519|E1|Reported Event|Atenolol +HCTZ Arm|atenolol 50 mg, then 100 mg if BP < 120/70, then add HCTZ 12.5 mg if BP < 120/70, then HCTZ 25 mg if BP < 120/70
1215391|NCT00246376|B6|Baseline|Total|Total of all reporting groups
1215392|NCT00246376|B5|Baseline|Group 5: Diet / Exercise + Niacin + Fenofibrate|Diet, exercise, Fenofibrate and Niaspan
1215393|NCT00246376|B4|Baseline|Group 4: Diet / Exercise + Niacin|Diet, exercise, Fenofibrate placebo, and Niaspan
1215394|NCT00246376|B3|Baseline|Group 3: Diet / Exercise + Fenofibrate|Diet, exercise, Fenofibrate, and Niaspan placebo
1215395|NCT00246376|B2|Baseline|Group 2: Diet / Exercise|Diet, exercise, and two placebos
1215396|NCT00246376|B1|Baseline|Group 1: Usual Care|Subjects receive lifestyle advice and placebos for Niaspan and Tricor
1215397|NCT00246376|P5|Participant Flow|Group 5: Diet / Exercise + Niacin + Fenofibrate|Diet, exercise, Fenofibrate and Niaspan
1215398|NCT00246376|P4|Participant Flow|Group 4: Diet / Exercise + Niacin|Diet, exercise, Fenofibrate placebo, and Niaspan
1215399|NCT00246376|P3|Participant Flow|Group 3: Diet / Exercise + Fenofibrate|Diet, exercise, Fenofibrate, and Niaspan placebo
1215400|NCT00246376|P2|Participant Flow|Group 2: Diet / Exercise|Diet, exercise, and two placebos
1215401|NCT00246376|P1|Participant Flow|Group 1: Usual Care|Subjects receive lifestyle advice and placebos for Niaspan and Tricor
1215402|NCT00246376|O5|Outcome|Group 5 - Diet/Exercise + Fenofibrate + Niacin|These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
1215403|NCT00246376|O4|Outcome|Group 4 - Diet/Exercise + Niacin|These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.
1215404|NCT00246376|O3|Outcome|Group 3 - Diet/Exercise + Fenofibrate|These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.
1215405|NCT00246376|O2|Outcome|Group 2 - Diet/Exercise Only|These subjects participated in the diet/exercise program and took placebos.
1215406|NCT00246376|O1|Outcome|Group 1 - Usual Care|These subjects did not participate in the diet/exercise program and took placebos.
1215407|NCT00246376|O5|Outcome|Group 5 - Diet/Exercise + Fenofibrate + Niacin|These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
1215408|NCT00246376|O4|Outcome|Group 4 - Diet/Exercise + Niacin|These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.
1215409|NCT00246376|O3|Outcome|Group 3 - Diet/Exercise + Fenofibrate|These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.
1215410|NCT00246376|O2|Outcome|Group 2 - Diet/Exercise Only|These subjects participated in the diet/exercise program and took placebos.
1215411|NCT00246376|O1|Outcome|Group 1 - Usual Care|These subjects did not participate in the diet/exercise program and took placebos.
1215412|NCT00246376|O5|Outcome|Group 5 - Diet/Exercise + Fenofibrate + Niacin|These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
1215413|NCT00246376|O4|Outcome|Group 4 - Diet/Exercise + Niacin|These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.
1215414|NCT00246376|O3|Outcome|Group 3 - Diet/Exercise + Fenofibrate|These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.
1215418|NCT00246376|O4|Outcome|Group 4 - Diet/Exercise + Niacin|These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.
1215419|NCT00246376|O3|Outcome|Group 3 - Diet/Exercise + Fenofibrate|These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.
1215420|NCT00246376|O2|Outcome|Group 2 - Diet/Exercise Only|These subjects participated in the diet/exercise program and took placebos.
1215421|NCT00246376|O1|Outcome|Group 1 - Usual Care|These subjects did not participate in the diet/exercise program and took placebos.
1215422|NCT00246376|O5|Outcome|Group 5 - Diet/Exercise + Fenofibrate + Niacin|
1215423|NCT00246376|O4|Outcome|Group 4 - Diet/Exercise + Niacin|
1215424|NCT00246376|O3|Outcome|Group 3 - Diet/Exercise + Fenofibrate|
1215425|NCT00246376|O2|Outcome|Group 2 - Diet/Exercise|
1215426|NCT00246376|O1|Outcome|Group 1 - Usual Care|
1215433|NCT00246376|O4|Outcome|Group 4 - Diet/Exercise + Niacin|These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.
1215434|NCT00246376|O3|Outcome|Group 3 - Diet/Exercise + Fenofibrate|These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.
1215435|NCT00246376|O2|Outcome|Group 2 - Diet/Exercise Only|These subjects participated in the diet/exercise program and took placebos.
1215436|NCT00246376|O1|Outcome|Group 1 - Usual Care|These subjects did not participate in the diet/exercise program and took placebos.
1215437|NCT00246376|E5|Reported Event|Group 5: Diet / Exercise + Niacin + Fenofibrate|Diet, exercise, Fenofibrate and Niaspan
1215438|NCT00246376|E4|Reported Event|Group 4: Diet / Exercise + Niacin|Diet, exercise, Fenofibrate placebo, and Niaspan
1215439|NCT00246376|E3|Reported Event|Group 3: Diet / Exercise + Fenofibrate|Diet, exercise, Fenofibrate, and Niaspan placebo
1215440|NCT00246376|E2|Reported Event|Group 2: Diet / Exercise|Diet, exercise, and two placebos
1215441|NCT00246376|E1|Reported Event|Group 1: Usual Care|Subjects receive lifestyle advice and placebos for Niaspan and Tricor
1215442|NCT00246337|B10|Baseline|Total|Total of all reporting groups
1215443|NCT00246337|B9|Baseline|Rizatriptan 10 mg|"Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
1215444|NCT00246337|B8|Baseline|MK0974 600 mg|"MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
1215445|NCT00246337|B7|Baseline|MK0974 400 mg|"MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
1215446|NCT00246337|B6|Baseline|MK0974 300 mg|"MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
1215447|NCT00246337|B5|Baseline|MK0974 200 mg|"MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
1215448|NCT00246337|B4|Baseline|MK0974 100 mg|"MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
1215449|NCT00246337|B3|Baseline|MK0974 50 mg|"MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
1215450|NCT00246337|B2|Baseline|MK0974 25 mg|"MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
1215451|NCT00246337|B1|Baseline|Placebo|"Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
1215452|NCT00246337|P9|Participant Flow|Rizatriptan 10 mg|Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215453|NCT00246337|P8|Participant Flow|MK0974 600 mg|MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215454|NCT00246337|P7|Participant Flow|MK0974 400 mg|MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215455|NCT00246337|P6|Participant Flow|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215456|NCT00246337|P5|Participant Flow|MK0974 200 mg|MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215457|NCT00246337|P4|Participant Flow|MK0974 100 mg|MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215458|NCT00246337|P3|Participant Flow|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215459|NCT00246337|P2|Participant Flow|MK0974 25 mg|MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215460|NCT00246337|P1|Participant Flow|Placebo|Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
1215461|NCT00246337|O9|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215462|NCT00246337|O8|Outcome|MK0974 600 mg|MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215463|NCT00246337|O7|Outcome|MK0974 400 mg|MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215464|NCT00246337|O6|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215465|NCT00246337|O5|Outcome|MK0974 200 mg|MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215466|NCT00246337|O4|Outcome|MK0974 100 mg|MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1224997|NCT00186888|O1|Outcome|Baseline|At study entry.
1215467|NCT00246337|O3|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215468|NCT00246337|O2|Outcome|MK0974 25 mg|MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215469|NCT00246337|O1|Outcome|Placebo|Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
1215470|NCT00246337|O9|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215471|NCT00246337|O8|Outcome|MK0974 600 mg|MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215472|NCT00246337|O7|Outcome|MK0974 400 mg|MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215473|NCT00246337|O6|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215474|NCT00246337|O5|Outcome|MK0974 200 mg|MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215475|NCT00246337|O4|Outcome|MK0974 100 mg|MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215476|NCT00246337|O3|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215477|NCT00246337|O2|Outcome|MK0974 25 mg|MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215478|NCT00246337|O1|Outcome|Placebo|Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
1215479|NCT00246337|O9|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215480|NCT00246337|O8|Outcome|MK0974 600 mg|MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215481|NCT00246337|O7|Outcome|MK0974 400 mg|MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215482|NCT00246337|O6|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215483|NCT00246337|O5|Outcome|MK0974 200 mg|MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215484|NCT00246337|O4|Outcome|MK0974 100 mg|MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215485|NCT00246337|O3|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215486|NCT00246337|O2|Outcome|MK0974 25 mg|MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215487|NCT00246337|O1|Outcome|Placebo|Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
1215488|NCT00246337|O9|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215489|NCT00246337|O8|Outcome|MK0974 600 mg|MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215490|NCT00246337|O7|Outcome|MK0974 400 mg|MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215491|NCT00246337|O6|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215492|NCT00246337|O5|Outcome|MK0974 200 mg|MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215493|NCT00246337|O4|Outcome|MK0974 100 mg|MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215494|NCT00246337|O3|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215495|NCT00246337|O2|Outcome|MK0974 25 mg|MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215496|NCT00246337|O1|Outcome|Placebo|Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
1215497|NCT00246337|E9|Reported Event|Rizatriptan 10 mg|Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215498|NCT00246337|E8|Reported Event|MK0974 600 mg|MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215499|NCT00246337|E7|Reported Event|MK0974 400 mg|MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215500|NCT00246337|E6|Reported Event|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215501|NCT00246337|E5|Reported Event|MK0974 200 mg|MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215502|NCT00246337|E4|Reported Event|MK0974 100 mg|MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215503|NCT00246337|E3|Reported Event|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215504|NCT00246337|E2|Reported Event|MK0974 25 mg|MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
1215505|NCT00246337|E1|Reported Event|Placebo|Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
1215506|NCT00246324|B1|Baseline|Inteferon, Then Interferon With Doxycycline|Men and women with RRMS who had received interferon beta-1a intramuscularly for at least six months and were experiencing breakthrough disease activity with the most recent relapse within 60 days of study entry.
1215507|NCT00246324|P1|Participant Flow|Inteferon, Then Interferon With Doxycycline|Men and women with RRMS who had received interferon beta-1a intramuscularly for at least six months and were experiencing breakthrough disease activity with the most recent relapse within 60 days of study entry.
1215508|NCT00246324|O1|Outcome|Inteferon, Then Interferon With Doxycycline|Men and women with RRMS who had received interferon beta-1a intramuscularly for at least six months and were experiencing breakthrough disease activity with the most recent relapse within 60 days of study entry.
1215509|NCT00246324|O1|Outcome|Inteferon, Then Interferon With Doxycycline|Men and women with RRMS who had received interferon beta-1a intramuscularly for at least six months and were experiencing breakthrough disease activity with the most recent relapse within 60 days of study entry.
1215510|NCT00246324|E1|Reported Event|Inteferon, Then Interferon With Doxycycline|Men and women with RRMS who had received interferon beta-1a intramuscularly for at least six months and were experiencing breakthrough disease activity with the most recent relapse within 60 days of study entry.
1215511|NCT00246259|B3|Baseline|Total|Total of all reporting groups
1215512|NCT00246259|B2|Baseline|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
1215513|NCT00246259|B1|Baseline|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
1215514|NCT00246259|P2|Participant Flow|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
1215515|NCT00246259|P1|Participant Flow|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
1215516|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
1215517|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
1215518|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
1215519|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
1215520|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
1215521|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
1215522|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
1215523|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
1215524|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
1215525|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
1215526|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
1215550|NCT00246090|O1|Outcome|E7389 1.4 mg/m^2|E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
1215551|NCT00246090|O1|Outcome|E7389 1.4 mg/m^2|E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
1215527|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
1215528|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
1215529|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
1215530|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
1215531|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
1215532|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
1215533|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
1215534|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
1215535|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
1215536|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
1215537|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
1215538|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
1215539|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
1215540|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
1215541|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
1215542|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
1215543|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
1215544|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
1215594|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
1215545|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
1215546|NCT00246259|E2|Reported Event|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
1215547|NCT00246259|E1|Reported Event|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
1215548|NCT00246090|B1|Baseline|E7389 1.4 mg/m^2|E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
1215549|NCT00246090|P1|Participant Flow|E7389 1.4 mg/m^2|E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
1215552|NCT00246090|E1|Reported Event|E7389 1.4 mg/m^2|E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
1215553|NCT00246025|B5|Baseline|Total|Total of all reporting groups
1215554|NCT00246025|B4|Baseline|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
1215555|NCT00246025|B3|Baseline|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
1215556|NCT00246025|B2|Baseline|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
1215557|NCT00246025|B1|Baseline|Treatment Group With Placebo|Patients were treated with matching Placebo.
1215558|NCT00246025|P4|Participant Flow|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
1215559|NCT00246025|P3|Participant Flow|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
1215560|NCT00246025|P2|Participant Flow|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
1215561|NCT00246025|P1|Participant Flow|Treatment Group With Placebo|Patients were treated with matching Placebo.
1215562|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
1215563|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
1215564|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
1215565|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
1215566|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
1215567|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
1215568|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
1215569|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
1215570|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
1215571|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
1215572|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
1215573|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
1215574|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
1215575|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
1215576|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
1215577|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
1215578|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
1215579|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
1215580|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
1215581|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
1215582|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
1215583|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
1215584|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
1215585|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
1215586|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
1215587|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
1215588|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
1215589|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
1215590|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
1215591|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
1215592|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
1215593|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
1215596|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
1215597|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
1215598|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
1215599|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
1215600|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
1215601|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
1215602|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
1215603|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
1215604|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
1215605|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
1215606|NCT00246025|E4|Reported Event|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
1215607|NCT00246025|E3|Reported Event|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
1215608|NCT00246025|E2|Reported Event|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
1215609|NCT00246025|E1|Reported Event|Treatment Group With Placebo|Patients were treated with matching Placebo.
1215610|NCT00246012|B10|Baseline|Total|Total of all reporting groups
1215611|NCT00246012|B9|Baseline|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1215612|NCT00246012|B8|Baseline|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
1215613|NCT00246012|B7|Baseline|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
1215614|NCT00246012|B6|Baseline|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
1215615|NCT00246012|B5|Baseline|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1215616|NCT00246012|B4|Baseline|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1215617|NCT00246012|B3|Baseline|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
1215618|NCT00246012|B2|Baseline|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
1215619|NCT00246012|B1|Baseline|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
1215620|NCT00246012|P9|Participant Flow|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1215733|NCT00245856|P1|Participant Flow|Dalteparin + Warfarin|"200 units per kg with transition Warfarin titrated to INR 2-3~This arm was completed and new treatment regimen was substituted for the remainder of the study."
1215734|NCT00245856|O1|Outcome|Dalteparin + Warfarin/Dalteparin Alone|Major bleeding rates
1215621|NCT00246012|P8|Participant Flow|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
1215622|NCT00246012|P7|Participant Flow|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
1215623|NCT00246012|P6|Participant Flow|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
1215748|NCT00245102|P4|Participant Flow|Undifferentiated Pleomorphic Sarcoma|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1216033|NCT00244621|O3|Outcome|Atacand .40 mg|candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
1215624|NCT00246012|P5|Participant Flow|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1215625|NCT00246012|P4|Participant Flow|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1215626|NCT00246012|P3|Participant Flow|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
1215627|NCT00246012|P2|Participant Flow|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
1215628|NCT00246012|P1|Participant Flow|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
1215629|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1215630|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
1215631|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
1215632|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
1215633|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
1215634|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
1215635|NCT00246012|O1|Outcome|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
1215735|NCT00245856|O1|Outcome|Dalteparin + Warfarin or Dalteparin Alone|Patients with arm DVT who received either 3 months of dalteparin + warfarin (INR 2-3) or Dalteparin alone
1215636|NCT00246012|O2|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1215637|NCT00246012|O1|Outcome|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1217185|NCT00237809|E3|Reported Event|D-serine/Cog Rehab|"D-serine/cog rehab~D-serine : D-serine (30 mg/kg)"
1215638|NCT00246012|O2|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1215639|NCT00246012|O1|Outcome|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1215640|NCT00246012|O2|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1215641|NCT00246012|O1|Outcome|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1215642|NCT00246012|O2|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1215643|NCT00246012|O1|Outcome|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1215644|NCT00246012|O2|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1215645|NCT00246012|O1|Outcome|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1215646|NCT00246012|O2|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1215647|NCT00246012|O1|Outcome|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1215736|NCT00245856|O1|Outcome|All DVT Treated Patients|Participants received dalteparin 200units/kg followed by warfarin or dalteparin only for 3 months
1215648|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1215649|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
1215749|NCT00245102|P3|Participant Flow|Leiomyosarcoma|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1215650|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
1215651|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
1215652|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1215653|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
1215654|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
1215655|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
1215656|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1215657|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
1215658|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
1215659|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
1215660|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1215661|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
1215662|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
1215663|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
1215664|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1215665|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
1215666|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
1215667|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
1215668|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1215669|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
1215670|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
1215671|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
1215672|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1215673|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
1215674|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
1215675|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
1215676|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1215677|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
1215678|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
1215679|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
1215680|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1215681|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
1215682|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
1215683|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
1215684|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1215685|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
1215686|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
1215687|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
1215688|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
1215689|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
1215690|NCT00246012|O1|Outcome|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
1215691|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
1215692|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
1215693|NCT00246012|O1|Outcome|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
1215694|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
1215695|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
1215742|NCT00245102|B4|Baseline|Undifferentiated Pleomorphic Sarcoma|Sorafenib 400 mg PO BID
1215696|NCT00246012|O1|Outcome|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
1215697|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
1217186|NCT00237809|E2|Reported Event|Placebo/Cog Rehab|"Placebo/cog rehab~Cognitive retraining : Cog rehab"
1215698|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
1215699|NCT00246012|O1|Outcome|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
1215700|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
1215701|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
1215702|NCT00246012|O1|Outcome|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
1215703|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
1215704|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
1215705|NCT00246012|O1|Outcome|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
1215706|NCT00246012|O5|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1215707|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1215708|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
1215709|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
1215737|NCT00245856|E2|Reported Event|Dalteparin Only|200 units/kg for one month At month one, dosage reduction based on weight
1215738|NCT00245856|E1|Reported Event|Dalteparin + Warfarin|"200 units per kg with transition Warfarin titrated to INR 2-3~This arm was completed and new treatment regimen was substituted for the remainder of the study."
1215739|NCT00245102|B7|Baseline|Total|Total of all reporting groups
1215740|NCT00245102|B6|Baseline|Other Histology|Sorafenib 400 mg PO BID
1215710|NCT00246012|O1|Outcome|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
1215750|NCT00245102|P2|Participant Flow|MPNST|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1215711|NCT00246012|E9|Reported Event|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1215712|NCT00246012|E8|Reported Event|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
1215713|NCT00246012|E7|Reported Event|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
1215714|NCT00246012|E6|Reported Event|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
1215715|NCT00246012|E5|Reported Event|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1215716|NCT00246012|E4|Reported Event|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
1215717|NCT00246012|E3|Reported Event|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
1215718|NCT00246012|E2|Reported Event|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
1215719|NCT00246012|E1|Reported Event|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
1215720|NCT00245960|B3|Baseline|Total|Total of all reporting groups
1215721|NCT00245960|B2|Baseline|Etanercept and Placebo|Period 1 received etanercept 50mg and placebo weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
1215722|NCT00245960|B1|Baseline|Etanercept|Period 1 received etanercept 50mg bi-weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
1215723|NCT00245960|P2|Participant Flow|Etanercept and Placebo|Period 1 received etanercept 50mg and placebo weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
1215724|NCT00245960|P1|Participant Flow|Etanercept|Period 1 received etanercept 50mg bi-weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
1215725|NCT00245960|O2|Outcome|Etanercept and Placebo|Period 1 received etanercept 50mg and placebo weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
1215726|NCT00245960|O1|Outcome|Etanercept|Period 1 received etanercept 50mg bi-weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
1215727|NCT00245960|O2|Outcome|Etanercept and Placebo|Period 1 received etanercept 50mg and placebo weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
1215728|NCT00245960|O1|Outcome|Etanercept|Period 1 received etanercept 50mg bi-weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
1215729|NCT00245960|E2|Reported Event|Etanercept and Placebo|Period 1 received etanercept 50mg and placebo weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
1215730|NCT00245960|E1|Reported Event|Etanercept|Period 1 received etanercept 50mg bi-weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
1215731|NCT00245856|B1|Baseline|All DVT Treated Patients|Participants received dalteparin 200units/kg followed by warfarin or dalteparin only for 3 months
1215732|NCT00245856|P2|Participant Flow|Dalteparin Only|200 units/kg for one month At month one, dosage reduction based on weight
1215741|NCT00245102|B5|Baseline|Fibrosarcoma|Sorafenib 400 mg PO BID
1215746|NCT00245102|P6|Participant Flow|Other Histology|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1215747|NCT00245102|P5|Participant Flow|Fibrosarcoma|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1215860|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
1225778|NCT00181610|B4|Baseline|Total|Total of all reporting groups
1215751|NCT00245102|P1|Participant Flow|Angiosarcoma|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1215752|NCT00245102|O6|Outcome|Other Histology|Sorafenib 400 mg PO BID
1215753|NCT00245102|O5|Outcome|Fibrosarcoma|Sorafenib 400 mg PO BID
1215754|NCT00245102|O4|Outcome|Undifferentiated Pleomorphic Sarcoma|Sorafenib 400 mg PO BID
1215755|NCT00245102|O3|Outcome|Leiomyosarcoma|Sorafenib 400 mg PO BID
1215756|NCT00245102|O2|Outcome|MPNST|Sorafenib 400 mg PO BID
1215757|NCT00245102|O1|Outcome|Angiosarcoma|Sorafenib 400 mg PO BID
1215758|NCT00245102|E6|Reported Event|Other Histology|Sorafenib 400 mg PO BID
1215759|NCT00245102|E5|Reported Event|Fibrosarcoma|Sorafenib 400 mg PO BID
1215760|NCT00245102|E4|Reported Event|Undifferentiated Pleomorphic Sarcoma|Sorafenib 400 mg PO BID
1215761|NCT00245102|E3|Reported Event|Leiomyosarcoma|Sorafenib 400 mg PO BID
1215762|NCT00245102|E2|Reported Event|MPNST|Sorafenib 400 mg PO BID
1215763|NCT00245102|E1|Reported Event|Angiosarcoma|Sorafenib 400 mg PO BID
1215764|NCT00245063|B3|Baseline|Total|Total of all reporting groups
1215765|NCT00245063|B2|Baseline|Arm B|"Patients receive oral AZD2171 30 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO"
1215766|NCT00245063|B1|Baseline|Arm A|"Patients receive oral AZD2171 45 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO"
1215767|NCT00245063|P2|Participant Flow|Arm B|"Patients receive oral AZD2171 30 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO"
1215768|NCT00245063|P1|Participant Flow|Arm A|"Patients receive oral AZD2171 45 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO"
1215769|NCT00245063|O2|Outcome|Arm B|"Patients receive oral AZD2171 30 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO"
1215770|NCT00245063|O1|Outcome|Arm A|"Patients receive oral AZD2171 45 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO"
1215771|NCT00245063|E2|Reported Event|Arm B|"Patients receive oral AZD2171 30 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO"
1215772|NCT00245063|E1|Reported Event|Arm A|"Patients receive oral AZD2171 45 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO"
1215773|NCT00245050|B3|Baseline|Total|Total of all reporting groups
1215774|NCT00245050|B2|Baseline|Placebo|Arm II: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral placebo 100 mg twice daily on days 1-28.
1215775|NCT00245050|B1|Baseline|Pyridoxine|Arm I: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral pyridoxine 100 mg twice daily on days 1-28.
1215776|NCT00245050|P2|Participant Flow|Placebo|Arm II: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral placebo 100 mg twice daily on days 1-28.
1215777|NCT00245050|P1|Participant Flow|Pyridoxine|Arm I: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral pyridoxine 100 mg twice daily on days 1-28.
1215778|NCT00245050|O2|Outcome|Placebo|Arm II: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral placebo 100 mg twice daily on days 1-28.
1215779|NCT00245050|O1|Outcome|Pyridoxine|Arm I: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral pyridoxine 100 mg twice daily on days 1-28.
1215780|NCT00245050|O2|Outcome|Placebo|Arm II: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral placebo 100 mg twice daily on days 1-28.
1215781|NCT00245050|O1|Outcome|Pyridoxine|Arm I: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral pyridoxine 100 mg twice daily on days 1-28.
1215782|NCT00245050|E2|Reported Event|Placebo|Arm II: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral placebo 100 mg twice daily on days 1-28.
1215783|NCT00245050|E1|Reported Event|Pyridoxine|Arm I: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral pyridoxine 100 mg twice daily on days 1-28.
1215784|NCT00245011|B1|Baseline|Samarium-153/Stem Cell Transplant/Radiation|"Samarium Sm153 Lexidronam Pentasodium/Stem Cell Transplant/Radiation arm will receive Ifosphamide IV in preparation for peripheral blood stem cell transplant followed by stem cell collection. Samarium Sm153 Lexidronam Pentasodium is administered after collection of peripheral blood stem cells. Once counts recover, while receiving filgrastim daily, a 2nd, higher dose of Samarium-153 is given, followed in 14 days by stem cell infusion.~Filgrastim: Filgrastim will be administered every day til count recovery Ifosfamide: Ifosfamide will be administered as part of Stem Cell transplant prep.~Peripheral blood stem cell transplantation: Before administration of Samarium, collection of autologous hematopoietic stem cells Radiation: Radiation Dosimetry performed at 4, 24, 48, and 72 after each infusion of Sm-EDTMP.~Samarium Sm 153 lexidronam pentasodium: First dose of Sm-EDTMP administered after autologous stem cell collection. Second, higher dose, of SM-EDTMP administered 7 days later."
1215785|NCT00245011|P1|Participant Flow|Samarium-153/Stem Cell Transplant/Radiation|"Samarium Sm153 Lexidronam Pentasodium (Samarium)/Stem Cell Transplant/Radiation arm: receive Ifosphamide IV in preparation for peripheral blood stem cell transplant followed by collection of stem cells. Samarium is administered after collection of peripheral blood stem cells (PBCT). Once counts recover, while receiving filgrastim daily, a second, higher dose of Samarium-153 is given, followed in 14 days by infusion of the stem cells.~Filgrastim: administered daily until count recovery Ifosfamide: administered as part of Stem Cell transplant preparation. PBCT: Before administration of Samarium, collection of autologous hematopoietic stem cells Radiation: Radiation Dosimetry performed at 4, 24, 48, and 72 after each infusion of Sm-EDTMP.~Samarium: First dose is administered after autologous stem cell collection. Second, higher dose, of SM-EDTMP administered after count recover. 14 days after administration of higher dose, patient undergoes autologous stem cell infusion."
1216034|NCT00244621|O2|Outcome|Atacand .20 mg|candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
1215786|NCT00245011|O1|Outcome|Samarium-153/Stem Cell Transplant/Radiation|"Samarium Sm153 Lexidronam Pentasodium (^153Sm-EDTMP)/Stem Cell Transplant/Radiation arm will receive Ifosphamide IV in preparation for peripheral blood stem cell transplant followed by stem cell harvest. ^153Sm-EDTMP is administered after collection of peripheral blood stem cells. Once counts recover, while receiving filgrastim daily, a 2nd, higher dose of ^153Sm-EDTMP is given, followed in 14 days by stem cell infusion.~filgrastim: Filgrastim is administered every day til count recovery.~ifosfamide: Ifosfamide is administered as part of Stem Cell transplant prep.~peripheral blood stem cell harvesting: completed before administration of ^153Sm-EDTMP, collection of autologous hematopoietic stem cells.~radiation: Radiation Dosimetry performed at 4, 24, 48, and 72 after each infusion of ^153Sm-EDTMP.~^153Sm-EDTMP: First dose is administered after autologous stem cell collection. Second, higher dose, is administered 1 week later."
1215787|NCT00245011|E1|Reported Event|Samarium-153|"Cytoxan+Ifosfamide, Filgrastim pre samarium.'Sm-EDTMP (low dose). once counts recover, Sm-EDTMP (high dose) given. Peripheral blood stem cell transplantation is done 14 days later.~filgrastim: Filgrastim will be administered post post chemotherapy until target WBC count is achieved.~ifosfamide: Ifosfamide administered IV.~peripheral blood stem cell transplantation: Peripheral blood stem cell transplantation is done 14 days after 2nd dose of Samarium is delivered~Sm-EDTMP (low dose): Sm-EDTMP (low dose) administered after autologous stem cell collection~sm-EDTMP (higher dose): Upon blood cell count recovery from Sm-EDTMP (low dose), Sm-EDTMP (higher dose) is administered followed in 14 days by peripheral blood stem cell transplantation."
1215788|NCT00244933|B1|Baseline|Gemcitabine, Genistein (Novasoy), Tumor Biopsy|"Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.~genistein: Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.~gemcitabine: Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days~Tumor biopsy: Biopsy of tumor prior to dose of genistein (Novasoy)"
1215789|NCT00244933|P1|Participant Flow|Gemcitabine, Genistein (Novasoy), Tumor Biopsy|"Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.~genistein: Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.~gemcitabine: Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days~Tumor biopsy: Biopsy of tumor prior to dose of genistein (Novasoy)"
1215790|NCT00244933|O1|Outcome|Gemcitabine & Genistein|Gemcitabine, genistein (Novasoy), Tumor biopsy Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days: Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
1215791|NCT00244933|E1|Reported Event|Gemcitabine & Genistein|Gemcitabine, genistein (Novasoy), Tumor biopsy Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days: Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
1215792|NCT00244881|B1|Baseline|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
1215793|NCT00244881|P1|Participant Flow|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
1215794|NCT00244881|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
1215795|NCT00244881|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
1215796|NCT00244881|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
1215797|NCT00244881|E1|Reported Event|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
1215798|NCT00244855|B3|Baseline|Total|Total of all reporting groups
1215799|NCT00244855|B2|Baseline|No Previous Treatment|"Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.~pharmacological study: Correlative studies~rituximab: Given IV~dexamethasone: Given IV~laboratory biomarker analysis: Correlative studies"
1215800|NCT00244855|B1|Baseline|Previous Treatment|"Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.~pharmacological study: Correlative studies~rituximab: Given IV~dexamethasone: Given IV~laboratory biomarker analysis: Correlative studies"
1215801|NCT00244855|P2|Participant Flow|Previous Treatment|"Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.~pharmacological study: Correlative studies~rituximab: Given IV~dexamethasone: Given IV~laboratory biomarker analysis: Correlative studies"
1215802|NCT00244855|P1|Participant Flow|No Previous Treatment|"Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.~pharmacological study: Correlative studies~rituximab: Given IV~dexamethasone: Given IV~laboratory biomarker analysis: Correlative studies"
1215857|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
1215858|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
1215803|NCT00244855|O2|Outcome|Previous Treatment|"Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.~pharmacological study: Correlative studies~rituximab: Given IV~dexamethasone: Given IV~laboratory biomarker analysis: Correlative studies"
1215804|NCT00244855|O1|Outcome|No Previous Treatment|"Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.~pharmacological study: Correlative studies~rituximab: Given IV~dexamethasone: Given IV~laboratory biomarker analysis: Correlative studies"
1215879|NCT00245557|E2|Reported Event|Depressed (Baseline)|Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.
1215805|NCT00244855|O2|Outcome|No Previous Treatment|"Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.~pharmacological study: Correlative studies~rituximab: Given IV~dexamethasone: Given IV~laboratory biomarker analysis: Correlative studies"
1215806|NCT00244855|O1|Outcome|Previous Treatment|"Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.~pharmacological study: Correlative studies~rituximab: Given IV~dexamethasone: Given IV~laboratory biomarker analysis: Correlative studies"
1215807|NCT00244855|E2|Reported Event|No Previous Treatment|"Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.~pharmacological study: Correlative studies~rituximab: Given IV~dexamethasone: Given IV~laboratory biomarker analysis: Correlative studies"
1215808|NCT00244855|E1|Reported Event|Previous Treatment|"Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.~pharmacological study: Correlative studies~rituximab: Given IV~dexamethasone: Given IV~laboratory biomarker analysis: Correlative studies"
1215809|NCT00245635|B3|Baseline|Total|Total of all reporting groups
1215810|NCT00245635|B2|Baseline|Placebo|"Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.~Placebo: Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score."
1215811|NCT00245635|B1|Baseline|Fluoxetine|"Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.~Fluoxetine: Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score."
1215812|NCT00245635|P2|Participant Flow|Placebo|"Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.~Placebo: Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score."
1215813|NCT00245635|P1|Participant Flow|Fluoxetine|"Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.~Fluoxetine: Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score."
1215814|NCT00245635|O2|Outcome|Placebo|"Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.~Placebo: Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score."
1215815|NCT00245635|O1|Outcome|Fluoxetine|"Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.~Fluoxetine: Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score."
1215816|NCT00245635|E2|Reported Event|Placebo|"Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.~Placebo: Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score."
1215817|NCT00245635|E1|Reported Event|Fluoxetine|"Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.~Fluoxetine: Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score."
1215818|NCT00245570|B1|Baseline|Overall Study Population|All randomized patients
1215819|NCT00245570|P6|Participant Flow|Placebo/ Salmeterol/ Montelukast|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder."
1215820|NCT00245570|P5|Participant Flow|Placebo/ Montelukast/ Salmeterol|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo~inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder."
1215859|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
1215880|NCT00245557|E1|Reported Event|Healthy Controls (Baseline)|Healthy Controls undergo MRI and neuropsychological testing
1215881|NCT00245466|B4|Baseline|Total|Total of all reporting groups
1215882|NCT00245466|B3|Baseline|Degarelix 80 + 20|In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
1215883|NCT00245466|B2|Baseline|Degarelix 40/40 + 40|In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
1215821|NCT00245570|P4|Participant Flow|Salmeterol/ Placebo/ Montelukast|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder."
1215822|NCT00245570|P3|Participant Flow|Salmeterol / Montelukast/ Placebo|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder."
1215823|NCT00245570|P2|Participant Flow|Montelukast/ Placebo/ Salmeterol|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder."
1215824|NCT00245570|P1|Participant Flow|Montelukast/ Salmeterol/Placebo|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder."
1215825|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
1215826|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
1215827|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
1215828|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
1215829|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
1215830|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
1215831|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
1215832|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
1215833|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
1215834|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
1215835|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
1215836|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
1215837|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
1215838|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
1215839|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
1215840|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
1215841|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
1215842|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
1215843|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
1215844|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
1215845|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
1215846|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
1215847|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
1215848|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
1215849|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
1215850|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
1215851|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
1215852|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
1215853|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
1215854|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
1215855|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
1215856|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
1215861|NCT00245570|E6|Reported Event|Placebo/ Salmeterol/ Montelukast|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder."
1215862|NCT00245570|E5|Reported Event|Placebo/ Montelukast/ Salmeterol|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo~inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder."
1215863|NCT00245570|E4|Reported Event|Salmeterol/ Placebo/ Montelukast|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder."
1215864|NCT00245570|E3|Reported Event|Salmeterol / Montelukast/ Placebo|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder."
1215865|NCT00245570|E2|Reported Event|Montelukast/ Placebo/ Salmeterol|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder."
1215866|NCT00245570|E1|Reported Event|Montelukast/ Salmeterol/Placebo|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder."
1215867|NCT00245557|B3|Baseline|Total|Total of all reporting groups
1215868|NCT00245557|B2|Baseline|Depressed (Baseline)|Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.
1215869|NCT00245557|B1|Baseline|Healthy Controls (Baseline)|Healthy Controls undergo MRI and neuropsychological testing
1215870|NCT00245557|P2|Participant Flow|Depressed (Baseline)|Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.
1215871|NCT00245557|P1|Participant Flow|Healthy Controls (Baseline)|Healthy Controls undergo MRI and neuropsychological testing
1215872|NCT00245557|O3|Outcome|Post-treatment Depressed|
1215873|NCT00245557|O2|Outcome|Depressed (Baseline)|Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.
1215874|NCT00245557|O1|Outcome|Healthy Controls (Baseline)|Healthy Controls undergo MRI and neuropsychological testing
1215875|NCT00245557|O2|Outcome|Depressed (Baseline)|Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.
1215876|NCT00245557|O1|Outcome|Healthy Controls (Baseline)|Healthy Controls undergo MRI and neuropsychological testing
1215877|NCT00245557|O2|Outcome|Depressed (Baseline)|Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.
1215878|NCT00245557|O1|Outcome|Healthy Controls (Baseline)|Healthy Controls undergo MRI and neuropsychological testing
1215884|NCT00245466|B1|Baseline|Degarelix 80/80 + 40|In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
1215885|NCT00245466|P3|Participant Flow|Degarelix 80 + 20|In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
1215886|NCT00245466|P2|Participant Flow|Degarelix 40/40 + 40|In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
1215887|NCT00245466|P1|Participant Flow|Degarelix 80/80 + 40|In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
1215888|NCT00245466|O3|Outcome|Degarelix 80 + 20|In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
1215889|NCT00245466|O2|Outcome|Degarelix 40/40 + 40|In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
1215890|NCT00245466|O1|Outcome|Degarelix 80/80 + 40|In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
1215891|NCT00245466|O3|Outcome|Degarelix 80 + 20|In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
1215892|NCT00245466|O2|Outcome|Degarelix 40/40 + 40|In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
1215893|NCT00245466|O1|Outcome|Degarelix 80/80 + 40|In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
1215894|NCT00245466|O3|Outcome|Degarelix 80 + 20|In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
1215895|NCT00245466|O2|Outcome|Degarelix 40/40 + 40|In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
1215896|NCT00245466|O1|Outcome|Degarelix 80/80 + 40|In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
1215897|NCT00245466|E3|Reported Event|Degarelix 80 + 20|In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
1215898|NCT00245466|E2|Reported Event|Degarelix 40/40 + 40|In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
1215899|NCT00245466|E1|Reported Event|Degarelix 80/80 + 40|In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
1215900|NCT00245219|B4|Baseline|Total|Total of all reporting groups
1215901|NCT00245219|B3|Baseline|Education|The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
1216453|NCT00242619|O2|Outcome|Drop-Outs|Subjects who dropped out of the study.
1215902|NCT00245219|B2|Baseline|Peer Support|The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
1215903|NCT00245219|B1|Baseline|Health Tracking (Control)|Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
1215919|NCT00245128|B1|Baseline|Imatinib Mesylate (Gleevec)|Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.
1215920|NCT00245128|P1|Participant Flow|Imatinib Mesylate (Gleevec)|Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.
1215921|NCT00245128|O1|Outcome|Imatinib Mesylate (Gleevec)|Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.
1228293|NCT00166504|O1|Outcome|Vytorin|Ezetimibe 10 mg/Simvastatin 20 mg
1215904|NCT00245219|P3|Participant Flow|Education|The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
1215905|NCT00245219|P2|Participant Flow|Peer Support|The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
1215906|NCT00245219|P1|Participant Flow|Health Tracking (Control)|Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
1215907|NCT00245219|O3|Outcome|Education|The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
1215908|NCT00245219|O2|Outcome|Peer Support|The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
1215909|NCT00245219|O1|Outcome|Health Tracking (Control)|Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
1215910|NCT00245219|O3|Outcome|Education|The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
1215911|NCT00245219|O2|Outcome|Peer Support|The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
1215912|NCT00245219|O1|Outcome|Health Tracking (Control)|Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
1215913|NCT00245219|O3|Outcome|Education|The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
1215914|NCT00245219|O2|Outcome|Peer Support|The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
1215915|NCT00245219|O1|Outcome|Health Tracking (Control)|Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
1215916|NCT00245219|E3|Reported Event|Education|The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
1215952|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1216454|NCT00242619|O1|Outcome|Completers|Subjects who completed the study.
1215917|NCT00245219|E2|Reported Event|Peer Support|The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
1215918|NCT00245219|E1|Reported Event|Health Tracking (Control)|Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
1215922|NCT00245128|E1|Reported Event|Imatinib Mesylate (Gleevec)|Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.
1215923|NCT00244764|B1|Baseline|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
1215924|NCT00244764|P1|Participant Flow|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
1215925|NCT00244764|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
1215926|NCT00244764|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
1215927|NCT00244764|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
1215928|NCT00244764|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
1215929|NCT00244764|E1|Reported Event|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
1215930|NCT00244725|B5|Baseline|Total|Total of all reporting groups
1215931|NCT00244725|B4|Baseline|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
1215932|NCT00244725|B3|Baseline|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215933|NCT00244725|B2|Baseline|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215934|NCT00244725|B1|Baseline|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215935|NCT00244725|P4|Participant Flow|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target International Normalized Ratio (INR) of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
1215936|NCT00244725|P3|Participant Flow|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet at Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215937|NCT00244725|P2|Participant Flow|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet at Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215938|NCT00244725|P1|Participant Flow|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil modified release (MR) 250 mg tablet at every 12 hours interval (Q12h)for the duration of 10 ± 2 days of double-blind treatment period.
1215939|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
1215940|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215941|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215942|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215943|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
1215944|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215945|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215946|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215947|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
1215948|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215949|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215950|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215951|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
1215953|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215954|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215955|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
1215956|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215957|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215958|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215959|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
1215960|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215961|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215962|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215963|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
1215964|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215965|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215966|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215967|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
1215968|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215969|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215970|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215971|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
1215972|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215973|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215974|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215975|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
1215976|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215977|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215978|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215979|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
1215980|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215981|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215982|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215983|NCT00244725|O4|Outcome|Warfarin INR 2.0 to 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
1216024|NCT00244712|E2|Reported Event|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
1215984|NCT00244725|O3|Outcome|Odiparcil MR 500 mg Tablet|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215985|NCT00244725|O2|Outcome|Odiparcil MR 375 mg Tablet|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215986|NCT00244725|O1|Outcome|Odiparcil MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215987|NCT00244725|E4|Reported Event|WARFARIN INR 2.0 TO 3.0|Eligible participants received overencapsulated warfarin 1 mg and 5 mg as guided by investigator to adjust warfarin to a target INR of 2.0 to 3.0 according to the investigators practice or participant status for the duration of 10 ± 2 days of double-blind treatment period.
1216032|NCT00244621|P1|Participant Flow|Atacand .05 mg|candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
1215988|NCT00244725|E3|Reported Event|ODIPARCIL MR 500 MG TABLET|Eligible participants received Odiparcil MR 500 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215989|NCT00244725|E2|Reported Event|ODIPARCIL MR 375 MG TABLET|Eligible participants received Odiparcil MR 375 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215990|NCT00244725|E1|Reported Event|ODIPARCIL MR 250 mg Tablet|Eligible participants received Odiparcil MR 250 mg tablet, Q12h for the duration of 10 ± 2 days of double-blind treatment period.
1215991|NCT00244712|B3|Baseline|Total|Total of all reporting groups
1215992|NCT00244712|B2|Baseline|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
1215993|NCT00244712|B1|Baseline|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
1215994|NCT00244712|P2|Participant Flow|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
1215995|NCT00244712|P1|Participant Flow|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
1215996|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
1215997|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
1215998|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
1215999|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
1216000|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
1216001|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
1216002|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
1216003|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
1216004|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
1216005|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
1216006|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
1216007|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
1216008|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
1216009|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
1216010|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
1216011|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
1216012|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
1216013|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
1216014|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
1216015|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
1216016|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
1216017|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
1216018|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
1216019|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
1216020|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
1216021|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
1216022|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
1216023|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
1216025|NCT00244712|E1|Reported Event|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
1216026|NCT00244621|B4|Baseline|Total|Total of all reporting groups
1216027|NCT00244621|B3|Baseline|Atacand .40 mg|candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
1216028|NCT00244621|B2|Baseline|Atacand .20 mg|candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
1216029|NCT00244621|B1|Baseline|Atacand .05 mg|candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
1216030|NCT00244621|P3|Participant Flow|Atacand .40 mg|candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
1216031|NCT00244621|P2|Participant Flow|Atacand .20 mg|candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
1216035|NCT00244621|O1|Outcome|Atacand .05 mg|candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
1216036|NCT00244621|O3|Outcome|Atacand .40 mg|candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
1216037|NCT00244621|O2|Outcome|Atacand .20 mg|candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
1216038|NCT00244621|O1|Outcome|Atacand .05 mg|candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
1216039|NCT00244621|O3|Outcome|Atacand .40 mg|candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
1216040|NCT00244621|O2|Outcome|Atacand .20 mg|candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
1216041|NCT00244621|O1|Outcome|Atacand .05 mg|candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
1216042|NCT00244621|O3|Outcome|Atacand .40 mg|candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
1216043|NCT00244621|O2|Outcome|Atacand .20 mg|candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
1216044|NCT00244621|O1|Outcome|Atacand .05 mg|candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
1216045|NCT00244621|E3|Reported Event|Atacand .40 mg|candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
1216046|NCT00244621|E2|Reported Event|Atacand .20 mg|candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
1216047|NCT00244621|E1|Reported Event|Atacand .05 mg|candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
1216048|NCT00244374|B1|Baseline|All Participants|Participants in pre-randomization cross-sectional study
1216049|NCT00244374|P5|Participant Flow|SEP + Outreach|Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
1216050|NCT00244374|P4|Participant Flow|SEP Only|Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6.
1216051|NCT00244374|P3|Participant Flow|AIC + Outreach|Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC)) for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
1216052|NCT00244374|P2|Participant Flow|AIC Only|Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC), for administration of viral hepatitis immunizations at Month 1, 2, 6.
1216053|NCT00244374|P1|Participant Flow|Cross-sectional/Screening|Cross-sectional screening to determine eligibility for vaccine adherence trial
1216054|NCT00244374|O1|Outcome|Screening Study Participants|Participants enrolled in the pre-randomization cross-sectional screening study completed a 60-minute survey, received client-centered risk reduction counseling, and underwent phlebotomy for viral testing. Participants were invited to return one week later for viral testing results, counseling, referrals, and subsequent enrollment in the vaccine adherence cohort study, if eligible.
1216055|NCT00244374|O1|Outcome|Cross-sectional Study Participants|Participants enrolled in the pre-randomization cross-sectional screening study completed a 60-minute survey, received client-centered risk reduction counseling, and underwent phlebotomy for viral testing. Participants were invited to return one week later for viral testing results, counseling, referrals, and subsequent enrollment in the vaccine adherence cohort study, if eligible.
1216056|NCT00244374|O2|Outcome|Did Not Travel in the Prior 3 Months|"Participants who answered no when asked if they had been on the road or traveling outside of San Francisco in the prior 3 months, or whose last 3 travel destinations within 30 miles of San Francisco"
1216057|NCT00244374|O1|Outcome|Traveled in the Prior 3 Months|"Participants who answered yes when asked if they had been on the road or traveling outside of San Francisco in the prior 3 months, and whose last 3 travel destinations were at least 30 miles from San Francisco"
1216058|NCT00244374|O2|Outcome|Anti-HCV Negative|Participants tested negative for Hepatitis C Virus (HCV) antibody
1216059|NCT00244374|O1|Outcome|Anti-HCV Positive|Participants tested positive for Hepatitis C Virus (HCV) antibody
1216060|NCT00244374|O4|Outcome|SEP + Outreach|Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
1216061|NCT00244374|O3|Outcome|SEP Only|Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6.
1216062|NCT00244374|O2|Outcome|AIC + Outreach|Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC)) for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
1216063|NCT00244374|O1|Outcome|AIC Only|Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC), for administration of viral hepatitis immunizations at Month 1, 2, 6.
1216064|NCT00244374|E4|Reported Event|SEP + Outreach|Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
1216065|NCT00244374|E3|Reported Event|SEP Only|Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6.
1216066|NCT00244374|E2|Reported Event|AIC + Outreach|Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC)) for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
1216067|NCT00244374|E1|Reported Event|AIC Only|Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC), for administration of viral hepatitis immunizations at Month 1, 2, 6.
1216068|NCT00244140|B3|Baseline|Total|Total of all reporting groups
1216069|NCT00244140|B2|Baseline|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
1216070|NCT00244140|B1|Baseline|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
1216071|NCT00244140|P2|Participant Flow|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
1216072|NCT00244140|P1|Participant Flow|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
1216073|NCT00244140|O2|Outcome|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
1216074|NCT00244140|O1|Outcome|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
1216075|NCT00244140|O2|Outcome|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
1216076|NCT00244140|O1|Outcome|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
1216077|NCT00244140|O2|Outcome|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
1216078|NCT00244140|O1|Outcome|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
1216079|NCT00244140|O2|Outcome|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
1216080|NCT00244140|O1|Outcome|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
1216081|NCT00244140|E2|Reported Event|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
1216082|NCT00244140|E1|Reported Event|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
1216083|NCT00244101|B4|Baseline|Total|Total of all reporting groups
1216084|NCT00244101|B3|Baseline|ISX Group|Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.
1216085|NCT00244101|B2|Baseline|NCPAP Group|Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.
1216086|NCT00244101|B1|Baseline|PS Group|Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
1216087|NCT00244101|P3|Participant Flow|ISX Group|Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.
1216088|NCT00244101|P2|Participant Flow|NCPAP Group|Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.
1216089|NCT00244101|P1|Participant Flow|PS Group|Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
1216090|NCT00244101|O3|Outcome|ISX Group|Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.
1216091|NCT00244101|O2|Outcome|NCPAP Group|Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.
1216092|NCT00244101|O1|Outcome|PS Group|Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
1216093|NCT00244101|E3|Reported Event|NCPAP|initial management with bubble nCPAP and selective surfactant treatment
1216094|NCT00244101|E2|Reported Event|Surfactant Extubated to nCPAP|prophylactic surfactant with rapid extubation to bubble nCPAP
1216095|NCT00244101|E1|Reported Event|Prophylactic Surfactant|Prophylactic surfactant followed by mechanical ventilation
1216096|NCT00244010|B3|Baseline|Total|Total of all reporting groups
1216097|NCT00244010|B2|Baseline|Donors|Parents of patients were enrolled onto the SAAHAP study to provide hematopoietic stem cells.
1216098|NCT00244010|B1|Baseline|Patients|Patients were enrolled to treat refractory severe aplastic anemia.
1216099|NCT00244010|P2|Participant Flow|Donors|Parents of patients were enrolled onto the SAAHAP study to provide hematopoietic stem cells.
1216100|NCT00244010|P1|Participant Flow|Patients|Patients were enrolled to treat refractory severe aplastic anemia.
1216101|NCT00244010|O2|Outcome|Donors|Parents of patients were enrolled onto the SAAHAP study to provide hematopoietic stem cells.
1216102|NCT00244010|O1|Outcome|Patients|Patients were enrolled to treat refractory severe aplastic anemia.
1216103|NCT00244010|E2|Reported Event|Donor|Donors were not assessed for adverse events.
1216104|NCT00244010|E1|Reported Event|Patients|Patients were enrolled to treat refractory severe aplastic anemia.
1216105|NCT00243932|B4|Baseline|Total|Total of all reporting groups
1216106|NCT00243932|B3|Baseline|1,800 mg CoQ10|35 patients. This dose group was discontinued after stage 1; only the 2,700 mg group was compared with placebo in the efficacy analysis.
1216107|NCT00243932|B2|Baseline|Placebo|35 subjects from stage 1 + 40 new subjects; all receiving placebo - total 75.
1216108|NCT00243932|B1|Baseline|2700mg CoQ10|35 subjects from stage 1 + 40 new subjects; all taking 2,700mg CoQ10 - total 75.
1216109|NCT00243932|P3|Participant Flow|1,800 mg CoQ10|35 patients. This dose group was discontinued after stage 1; only the 2,700 mg group was compared with placebo in the efficacy analysis.
1216110|NCT00243932|P2|Participant Flow|Placebo|35 subjects from stage 1 + 40 new subjects; all receiving placebo - total 75.
1216111|NCT00243932|P1|Participant Flow|2700mg CoQ10|35 subjects from stage 1 + 40 new subjects; all taking 2,700mg CoQ10 - total 75.
1216112|NCT00243932|O3|Outcome|1,800 mg CoQ10|35 patients. Mean and SD are presented but this group was not included in the efficacy analysis because the 1,800 mg dose was discontinued after stage 1.
1216113|NCT00243932|O2|Outcome|Placebo|40 new subjects plus 35 subjects from stage 1 receiving placebo - total 75.
1216114|NCT00243932|O1|Outcome|2700mg CoQ10|"40 new subjects and 35 subjects from stage 1 all taking 2,700mg CoQ10 - total 75.~Stage 1 - 35 participants per group compared CoQ10 doses of 1,800mg and 2,700 mg/day and placebo."
1217173|NCT00237809|O3|Outcome|D-serine/Cog Rehab|"D-serine/cog rehab~D-serine : D-serine (30 mg/kg)"
1216115|NCT00243932|E3|Reported Event|1,800 mg CoQ10|35 patients. This dose group was discontinued after stage 1; only the 2,700 mg group was compared with placebo in the efficacy analysis.
1216116|NCT00243932|E2|Reported Event|Placebo|35 subjects from stage 1 + 40 new subjects; all receiving placebo - total 75.
1216117|NCT00243932|E1|Reported Event|2700mg CoQ10|35 subjects from stage 1 + 40 new subjects; all taking 2,700mg CoQ10 - total 75.
1216118|NCT00243919|B4|Baseline|Total|Total of all reporting groups
1216119|NCT00243919|B3|Baseline|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
1216120|NCT00243919|B2|Baseline|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
1216168|NCT00243659|P1|Participant Flow|Bolus Injection|Approximately 50 IU/kg Refacto AF for 6 consecutive days
1216121|NCT00243919|B1|Baseline|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
1216122|NCT00243919|P3|Participant Flow|Home Exercise Program|Home Exercise Program (HEP) was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
1216123|NCT00243919|P2|Participant Flow|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
1216124|NCT00243919|P1|Participant Flow|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
1216125|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
1216126|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
1216127|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
1216128|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
1216129|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
1216130|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
1216131|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
1216132|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
1216133|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
1216134|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
1216135|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
1216136|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
1216137|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
1216138|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
1216139|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
1216140|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
1216141|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
1216142|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
1216169|NCT00243659|O2|Outcome|Continuous Infusion|Approximately 50 IU/Kg Refacto AF then continuously
1216170|NCT00243659|O1|Outcome|Bolus Injection|Approximately 50 IU/kg Refacto AF for 6 consecutive days
1216143|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
1216144|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
1216145|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
1216146|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
1216147|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
1216148|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
1216149|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
1216150|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
1216151|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
1216152|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
1216153|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
1216154|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
1216155|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
1216156|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
1216157|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
1216158|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
1216159|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
1216160|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
1216161|NCT00243919|E3|Reported Event|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
1216270|NCT00243386|O2|Outcome|Standard Prophylaxis|20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator
1216162|NCT00243919|E2|Reported Event|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
1216163|NCT00243919|E1|Reported Event|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
1216164|NCT00243659|B3|Baseline|Total|Total of all reporting groups
1216165|NCT00243659|B2|Baseline|Continuous Infusion|Approximately 50 IU/Kg Refacto AF then continuously
1216166|NCT00243659|B1|Baseline|Bolus Injection|Approximately 50 IU/kg Refacto AF for 6 consecutive days
1216167|NCT00243659|P2|Participant Flow|Continuous Infusion|Approximately 50 IU/Kg Refacto AF then continuously
1216173|NCT00243659|E2|Reported Event|Continuous Infusion|Approximately 50 IU/Kg Refacto AF then continuously
1216174|NCT00243659|E1|Reported Event|Bolus Injection|Approximately 50 IU/kg Refacto AF for 6 consecutive days
1216175|NCT00243503|B1|Baseline|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
1216176|NCT00243503|P1|Participant Flow|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
1216177|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
1216178|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
1216179|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
1216180|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
1216181|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
1216182|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
1216183|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
1216184|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
1216185|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
1216186|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
1216187|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles
1216188|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
1216189|NCT00243503|E1|Reported Event|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
1216190|NCT00243412|B3|Baseline|Total|Total of all reporting groups
1216449|NCT00242619|P2|Participant Flow|Drop-Outs|Subjects who dropped out and did not complete the 12 weeks on rosiglitazone.
1217869|NCT00235326|P1|Participant Flow|Unexposed to Gastroenteritis|
1216191|NCT00243412|B2|Baseline|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
1216192|NCT00243412|B1|Baseline|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
1216193|NCT00243412|P2|Participant Flow|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion, For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
1216512|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
1216194|NCT00243412|P1|Participant Flow|Arm A: 500 mg Rituximab|Rituximab: 1000 mg intravenous (IV) on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
1216195|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
1216196|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
1216197|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
1216198|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
1216199|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
1216200|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
1216201|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
1216202|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
1216203|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
1216204|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
1216205|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
1216450|NCT00242619|P1|Participant Flow|Completers|Subjects who completed the study and 12 weeks of taking rosiglitazone.
1216206|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
1216207|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
1216208|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
1216513|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
1216514|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
1216209|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
1216210|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
1216211|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
1216212|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
1216213|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
1216214|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
1216215|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
1216216|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
1216217|NCT00243412|E2|Reported Event|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
1216218|NCT00243412|E1|Reported Event|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
1216219|NCT00243386|B1|Baseline|All Study Participants|Participants first underwent an open-label evaluation of rAHF-PFM PK. 48 hours after the initial PK study, a 6 month period of on-demand treatment was conducted (Part 1). After completing the on-demand treatment, participants were randomized to 1 of 2 prophylactic regimens for 12 months ±2 weeks (Part 2). The standard prophylactic regimen was dosed at 20 to 40 IU/kg every 48 ±6 hours, and the PK-driven prophylaxis regimen was dosed at 20 to 80 IU/kg every 72 ±6 hours.
1216220|NCT00243386|P3|Participant Flow|Standard Prophylaxis|The standard prophylactic regimen was dosed at 20 to 40 IU/kg of rAHF-PFM every 48 ±6 hours
1216221|NCT00243386|P2|Participant Flow|PK-Driven Prophylaxis|The PK-driven prophylaxis regimen was dosed at 20 to 80 IU/kg of rAHF-PFM every 72 ±6 hours
1216334|NCT00243061|B1|Baseline|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Correlative studies"
1217174|NCT00237809|O2|Outcome|Placebo/Cog Rehab|"Placebo/cog rehab~Cognitive retraining : Cog rehab"
1216222|NCT00243386|P1|Participant Flow|All Study Participants|Participants first underwent an open-label pharmacokinetic (PK) evaluation of rAHF-PFM. 48 hours after the initial PK study, a 6 month period of on-demand treatment was conducted (Part 1). After completing the on-demand treatment, participants were randomized to 1 of 2 prophylactic regimens for 12 months ±2 weeks (Part 2). The standard prophylactic regimen was dosed at 20 to 40 IU/kg every 48 ±6 hours, and the PK-driven prophylaxis regimen was dosed at 20 to 80 IU/kg every 72 ±6 hours.
1216223|NCT00243386|O4|Outcome|Any Prophylaxis|Either Standard or PK-driven Prophylaxis
1216224|NCT00243386|O3|Outcome|PK-driven Prophylaxis|Dosed at 20 to 80 IU/kg every 72 ±6 hours for 12 months (Part 2)
1216225|NCT00243386|O2|Outcome|Standard Prophylaxis|Dosed at 20 to 40 IU/kg every 48 ±6 hours for 12 months (Part 2)
1216226|NCT00243386|O1|Outcome|On-Demand Regimen|After the initial PK study, a 6 month period of on-demand treatment was conducted (Part 1)
1216339|NCT00243061|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally"
1216227|NCT00243386|O1|Outcome|≥14 Years of Age|After an on-demand treatment period, participants were randomized to 1 of 2 prophylactic regimens for 12 months. The standard prophylactic regimen was dosed at 20 to 40 IU/kg every 48 ±6 hours, and the PK-driven prophylaxis regimen was dosed at 20 to 80 IU/kg every 72 ±6 hours.
1216228|NCT00243386|O1|Outcome|≥14 Years of Age|After an on-demand treatment period, participants were randomized to 1 of 2 prophylactic regimens for 12 months. The standard prophylactic regimen was dosed at 20 to 40 IU/kg every 48 ±6 hours, and the PK-driven prophylaxis regimen was dosed at 20 to 80 IU/kg every 72 ±6 hours.
1216229|NCT00243386|O2|Outcome|Standard Prophylaxis|Standard prophylaxis regimen dosed at 20 to 40 IU/kg every 48 ±6 hours
1216230|NCT00243386|O1|Outcome|PK-Driven Prophylaxis|PK-driven prophylaxis regimen dosed at 20 to 80 IU/kg every 72 ±6 hours
1216231|NCT00243386|O3|Outcome|On-Demand to Any Prophylaxis Treatment|
1216232|NCT00243386|O2|Outcome|On-Demand to PK-Driven Prophylaxis|
1216233|NCT00243386|O1|Outcome|On-Demand to Standard Prophylaxis|
1216234|NCT00243386|O4|Outcome|Any Prophylaxis Treatment|Any Prophylaxis Treatment (either Standard Prophylaxis or PK-Driven Prophylaxis) Standard Prophylaxis: 20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator PK-Driven Prophylaxis: 20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor
1216235|NCT00243386|O3|Outcome|PK-Driven Prophylaxis|20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor
1216236|NCT00243386|O2|Outcome|Standard Prophylaxis|20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator
1216237|NCT00243386|O1|Outcome|On-Demand Treatment|rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours
1216238|NCT00243386|O1|Outcome|Assessed Before Treatment|
1216239|NCT00243386|O3|Outcome|PK-Driven Prophylaxis|20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor
1216240|NCT00243386|O2|Outcome|Standard Prophylaxis|20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator
1216241|NCT00243386|O1|Outcome|On-Demand|rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours
1216242|NCT00243386|O1|Outcome|All Study Participants|All participants who were exposed to investigational product (IP)
1216243|NCT00243386|O4|Outcome|SAEs Outside of the 3 Treatment Arms|Participants with SAEs that occurred after exposure to investigational product, but outside of the three treatment arms
1216244|NCT00243386|O3|Outcome|PK-Driven Prophylaxis|20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor
1216245|NCT00243386|O2|Outcome|Standard Prophylaxis|20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator
1216246|NCT00243386|O1|Outcome|On-Demand|
1216247|NCT00243386|O3|Outcome|PK-Driven Prophylaxis|20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor
1216248|NCT00243386|O2|Outcome|Standard Prophylaxis|20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator
1216249|NCT00243386|O1|Outcome|On-Demand|rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours)
1216250|NCT00243386|O1|Outcome|All Study Participants|All participants who were exposed to IP
1216251|NCT00243386|O1|Outcome|All Study Participants|All participants who were exposed to IP
1216252|NCT00243386|O1|Outcome|All Study Participants|All participants who were exposed to Investigational Product (IP)
1216253|NCT00243386|O2|Outcome|<14 Years of Age|
1216254|NCT00243386|O1|Outcome|≥14 Years of Age|
1216255|NCT00243386|O2|Outcome|<14 Years of Age|
1216256|NCT00243386|O1|Outcome|≥14 Years of Age|
1216257|NCT00243386|O2|Outcome|<14 Years of Age|
1216258|NCT00243386|O1|Outcome|≥14 Years of Age|
1216259|NCT00243386|O2|Outcome|<14 Years of Age|
1216260|NCT00243386|O1|Outcome|≥14 Years of Age|
1216261|NCT00243386|O2|Outcome|<14 Years of Age|
1216262|NCT00243386|O1|Outcome|≥14 Years of Age|
1216263|NCT00243386|O2|Outcome|<14 Years of Age|
1216264|NCT00243386|O1|Outcome|≥14 Years of Age|
1216265|NCT00243386|O2|Outcome|<14 Years of Age|
1216266|NCT00243386|O1|Outcome|≥14 Years of Age|
1216267|NCT00243386|O2|Outcome|<14 Years of Age|
1216268|NCT00243386|O1|Outcome|≥14 Years of Age|
1216269|NCT00243386|O3|Outcome|PK-Driven Prophylaxis|20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor
1217175|NCT00237809|O1|Outcome|D-serine/Control|"D-serine/control~D-serine : D-serine (30 mg/kg)"
1216271|NCT00243386|O1|Outcome|On-Demand Regimen|rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours)
1216272|NCT00243386|O3|Outcome|PK-Driven Prophylaxis|20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor
1216273|NCT00243386|O2|Outcome|Standard Prophylaxis Treatment|20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator
1216340|NCT00243061|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally"
1216274|NCT00243386|O1|Outcome|On-Demand Treatment|rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours)
1216275|NCT00243386|O2|Outcome|Standard Prophylaxis|Standard prophylaxis regimen dosed at 20 to 40 IU/kg every 48 ±6 hours
1216276|NCT00243386|O1|Outcome|PK-Driven Prophylaxis|PK-driven prophylaxis regimen dosed at 20 to 80 IU/kg every 72 ±6 hours
1216277|NCT00243386|O1|Outcome|On-Demand Versus Any Prophylaxis|"On-demand: rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours)~Prophylaxis:~Standard prophylaxis: 20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator~PK-driven prophylaxis: 20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor"
1216278|NCT00243386|O1|Outcome|On-Demand Versus PK-Driven Prophylaxis|"On-demand: rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours)~PK-driven prophylaxis: 20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor"
1216279|NCT00243386|O1|Outcome|On-Demand Versus Standard Prophylaxis|"On-demand: rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, Gastrointestinal (GI), and intracranial (60-100 IU/kg every 8-12 hours)~Standard Prophylaxis: 20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator"
1216280|NCT00243386|O2|Outcome|Standard Prophylaxis|Standard prophylaxis regimen dosed at 20 to 40 IU/kg every 48 ±6 hours
1216281|NCT00243386|O1|Outcome|PK-Driven Prophylaxis|PK-driven prophylaxis regimen dosed at 20 to 80 IU/kg every 72 ±6 hours
1216282|NCT00243386|E4|Reported Event|SAEs Outside of the 3 Treatment Arms|Participants with SAEs that occurred after exposure to investigational product, but outside of the three treatment arms
1216283|NCT00243386|E3|Reported Event|PK-Driven Prophylaxis|PK-driven prophylaxis regimen dosed at 20 to 80 IU/kg (every 72 ±6 hours) exact regimen to be determined by the sponsor
1216284|NCT00243386|E2|Reported Event|Standard Prophylaxis|Standard prophylaxis regimen dosed at 20 to 40 IU/kg (every 48 ±6 hours), exact regimen to be determined by the investigator
1216285|NCT00243386|E1|Reported Event|On-Demand|On-demand: rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours)
1216286|NCT00243347|B1|Baseline|Cediranib 30 mg|Cediranib 30mg/Day
1216287|NCT00243347|P1|Participant Flow|Cediranib 30 mg|Cediranib 30mg/Day
1216288|NCT00243347|O1|Outcome|Cediranib 30 mg|Cediranib 30mg/Day
1216289|NCT00243347|O1|Outcome|Cediranib 30 mg|Cediranib 30mg/Day
1216290|NCT00243347|E1|Reported Event|Cediranib 30 mg|Cediranib 30mg/Day
1216291|NCT00243269|B5|Baseline|Total|Total of all reporting groups
1216292|NCT00243269|B4|Baseline|Active Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy- enhancing handout given to patients in Arm 1.~Patients received the same expectancy-enhancing CD given to patients in Arm 3."
1216293|NCT00243269|B3|Baseline|Control Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy-neutral handout given to patients in Arm 1.~Patients received the same relaxation CD as patients in the control condition with additional language inserted concerning efficacy of the acupressure bands and control of nausea. This additional language is under one minute in length and intended to strengthen patients’ beliefs that the acupressure bands would be effective by focusing patients’ attention on how effective the acupressure bands have been in reducing or eliminating nausea for other patients. In addition, it was suggested that since the acupressure bands were helpful to others, they might be helpful to them as well."
1216294|NCT00243269|B2|Baseline|Active Handout and Control Tape.|"Patients received two acupressure bands.~Patients received an expectancy-enhancing handout to enhance expected acupressure band efficacy. It was printed on Cancer Center letterhead and signed by a medical oncologist and two of the study investigators. The handout presented a very positive (and truthful) interpretation of the data from two prior acupressure band studies. Patients also received a medical prescription instructing them to use the acupressure bands for relief of nausea. The prescription was signed by a medical oncologist and had the instruction, “Wear Seabands for up to five days as needed to prevent or alleviate nausea.” Patients’ names were not on the prescription.~Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed."
1216451|NCT00242619|O2|Outcome|Drop-Outs|Subjects who dropped out and did not complete the 12 weeks on rosiglitazone.
1216305|NCT00243269|O3|Outcome|Control Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy-neutral handout given to patients in Arm 1.~Patients received the same relaxation CD as patients in the control condition with additional language inserted concerning efficacy of the acupressure bands and control of nausea. This additional language is under one minute in length and intended to strengthen patients’ beliefs that the acupressure bands would be effective by focusing patients’ attention on how effective the acupressure bands have been in reducing or eliminating nausea for other patients. In addition, it was suggested that since the acupressure bands were helpful to others, they might be helpful to them as well."
1228294|NCT00166504|E2|Reported Event|Atorvastatin|Atorvastatin 10 mg
1216295|NCT00243269|B1|Baseline|Control Handout and Control Tape.|Patients received two acupressure bands. Patients received an expectancy-neutral handout that simply thanked them for participating in the study. The wording of the letter was, “Thank you for agreeing to participate in this study regarding the use of acupressure bands to control chemotherapy-related nausea. The information you will provide is extremely valuable. It is only with the assistance of individuals, like you, who are willing to give their time that we can learn new ways to better control the side effects of cancer treatment. Wear the acupressure bands for up to five days, if helpful, to prevent or alleviate nausea. We are very appreciative of your contribution to this study.” Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
1216296|NCT00243269|P4|Participant Flow|Active Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy- enhancing handout given to patients in Arm 1.~Patients received the same expectancy-enhancing CD given to patients in Arm 3."
1216297|NCT00243269|P3|Participant Flow|Control Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy-neutral handout given to patients in Arm 1.~Patients received the same relaxation CD as patients in the control condition with additional language inserted concerning efficacy of the acupressure bands and control of nausea. This additional language is under one minute in length and intended to strengthen patients’ beliefs that the acupressure bands would be effective by focusing patients’ attention on how effective the acupressure bands have been in reducing or eliminating nausea for other patients. In addition, it was suggested that since the acupressure bands were helpful to others, they might be helpful to them as well."
1216298|NCT00243269|P2|Participant Flow|Active Handout and Control Tape.|"Patients received two acupressure bands.~Patients received an expectancy-enhancing handout to enhance expected acupressure band efficacy. It was printed on Cancer Center letterhead and signed by a medical oncologist and two of the study investigators. The handout presented a very positive (and truthful) interpretation of the data from two prior acupressure band studies. Patients also received a medical prescription instructing them to use the acupressure bands for relief of nausea. The prescription was signed by a medical oncologist and had the instruction, “Wear Seabands for up to five days as needed to prevent or alleviate nausea.” Patients’ names were not on the prescription.~Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed."
1216299|NCT00243269|P1|Participant Flow|Control Handout and Control Tape.|Patients received two acupressure bands. Patients received an expectancy-neutral handout that simply thanked them for participating in the study. The wording of the letter was, “Thank you for agreeing to participate in this study regarding the use of acupressure bands to control chemotherapy-related nausea. The information you will provide is extremely valuable. It is only with the assistance of individuals, like you, who are willing to give their time that we can learn new ways to better control the side effects of cancer treatment. Wear the acupressure bands for up to five days, if helpful, to prevent or alleviate nausea. We are very appreciative of your contribution to this study.” Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
1216300|NCT00243269|O4|Outcome|Active Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy- enhancing handout given to patients in Arm 1.~Patients received the same expectancy-enhancing CD given to patients in Arm 3."
1216301|NCT00243269|O3|Outcome|Control Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy-neutral handout given to patients in Arm 1.~Patients received the same relaxation CD as patients in the control condition with additional language inserted concerning efficacy of the acupressure bands and control of nausea. This additional language is under one minute in length and intended to strengthen patients’ beliefs that the acupressure bands would be effective by focusing patients’ attention on how effective the acupressure bands have been in reducing or eliminating nausea for other patients. In addition, it was suggested that since the acupressure bands were helpful to others, they might be helpful to them as well."
1216302|NCT00243269|O2|Outcome|Active Handout and Control Tape.|"Patients received two acupressure bands.~Patients received an expectancy-enhancing handout to enhance expected acupressure band efficacy. It was printed on Cancer Center letterhead and signed by a medical oncologist and two of the study investigators. The handout presented a very positive (and truthful) interpretation of the data from two prior acupressure band studies. Patients also received a medical prescription instructing them to use the acupressure bands for relief of nausea. The prescription was signed by a medical oncologist and had the instruction, “Wear Seabands for up to five days as needed to prevent or alleviate nausea.” Patients’ names were not on the prescription.~Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed."
1216303|NCT00243269|O1|Outcome|Control Handout and Control Tape.|Patients received two acupressure bands. Patients received an expectancy-neutral handout that simply thanked them for participating in the study. The wording of the letter was, “Thank you for agreeing to participate in this study regarding the use of acupressure bands to control chemotherapy-related nausea. The information you will provide is extremely valuable. It is only with the assistance of individuals, like you, who are willing to give their time that we can learn new ways to better control the side effects of cancer treatment. Wear the acupressure bands for up to five days, if helpful, to prevent or alleviate nausea. We are very appreciative of your contribution to this study.” Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
1216304|NCT00243269|O4|Outcome|Active Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy- enhancing handout given to patients in Arm 1.~Patients received the same expectancy-enhancing CD given to patients in Arm 3."
1216335|NCT00243061|P1|Participant Flow|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Correlative studies"
1216452|NCT00242619|O1|Outcome|Completers|Subjects who completed the study and 12 weeks of taking rosiglitazone.
1216306|NCT00243269|O2|Outcome|Active Handout and Control Tape.|"Patients received two acupressure bands.~Patients received an expectancy-enhancing handout to enhance expected acupressure band efficacy. It was printed on Cancer Center letterhead and signed by a medical oncologist and two of the study investigators. The handout presented a very positive (and truthful) interpretation of the data from two prior acupressure band studies. Patients also received a medical prescription instructing them to use the acupressure bands for relief of nausea. The prescription was signed by a medical oncologist and had the instruction, “Wear Seabands for up to five days as needed to prevent or alleviate nausea.” Patients’ names were not on the prescription.~Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed."
1216307|NCT00243269|O1|Outcome|Control Handout and Control Tape.|Patients received two acupressure bands. Patients received an expectancy-neutral handout that simply thanked them for participating in the study. The wording of the letter was, “Thank you for agreeing to participate in this study regarding the use of acupressure bands to control chemotherapy-related nausea. The information you will provide is extremely valuable. It is only with the assistance of individuals, like you, who are willing to give their time that we can learn new ways to better control the side effects of cancer treatment. Wear the acupressure bands for up to five days, if helpful, to prevent or alleviate nausea. We are very appreciative of your contribution to this study.” Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
1216308|NCT00243269|E4|Reported Event|Active Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy- enhancing handout given to patients in Arm 1.~Patients received the same expectancy-enhancing CD given to patients in Arm 3."
1216309|NCT00243269|E3|Reported Event|Control Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy-neutral handout given to patients in Arm 1.~Patients received the same relaxation CD as patients in the control condition with additional language inserted concerning efficacy of the acupressure bands and control of nausea. This additional language is under one minute in length and intended to strengthen patients’ beliefs that the acupressure bands would be effective by focusing patients’ attention on how effective the acupressure bands have been in reducing or eliminating nausea for other patients. In addition, it was suggested that since the acupressure bands were helpful to others, they might be helpful to them as well."
1216310|NCT00243269|E2|Reported Event|Active Handout and Control Tape.|"Patients received two acupressure bands.~Patients received an expectancy-enhancing handout to enhance expected acupressure band efficacy. It was printed on Cancer Center letterhead and signed by a medical oncologist and two of the study investigators. The handout presented a very positive (and truthful) interpretation of the data from two prior acupressure band studies. Patients also received a medical prescription instructing them to use the acupressure bands for relief of nausea. The prescription was signed by a medical oncologist and had the instruction, “Wear Seabands for up to five days as needed to prevent or alleviate nausea.” Patients’ names were not on the prescription.~Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed."
1216311|NCT00243269|E1|Reported Event|Control Handout and Control Tape.|Patients received two acupressure bands. Patients received an expectancy-neutral handout that simply thanked them for participating in the study. The wording of the letter was, “Thank you for agreeing to participate in this study regarding the use of acupressure bands to control chemotherapy-related nausea. The information you will provide is extremely valuable. It is only with the assistance of individuals, like you, who are willing to give their time that we can learn new ways to better control the side effects of cancer treatment. Wear the acupressure bands for up to five days, if helpful, to prevent or alleviate nausea. We are very appreciative of your contribution to this study.” Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
1216312|NCT00243243|B3|Baseline|Total|Total of all reporting groups
1216313|NCT00243243|B2|Baseline|Control|
1216314|NCT00243243|B1|Baseline|Experimental|Recombinant Factor VIIa : intravenous infusion of Factor VIIa
1216315|NCT00243243|P2|Participant Flow|Control- Placebo|Intravenous infusion of a placebo
1216316|NCT00243243|P1|Participant Flow|Experimental|Recombinant Factor VIIa : intravenous infusion of Factor VIIa
1216317|NCT00243243|O2|Outcome|Control- Placebo|Intravenous infusion of a placebo
1216318|NCT00243243|O1|Outcome|Experimental|Recombinant Factor VIIa : intravenous infusion of Factor VIIa
1216319|NCT00243243|E2|Reported Event|Control|
1216320|NCT00243243|E1|Reported Event|Experimental|Recombinant Factor VIIa : intravenous infusion of Factor VIIa
1216321|NCT00243191|B1|Baseline|Imatinib|
1216322|NCT00243191|P1|Participant Flow|Imatinib|
1216323|NCT00243191|O1|Outcome|Imatinib|
1216324|NCT00243191|E1|Reported Event|Imatinib|
1216325|NCT00243074|B1|Baseline|AZD2171|
1216326|NCT00243074|P1|Participant Flow|AZD2171 (Cediranib Maleate)|
1216327|NCT00243074|O1|Outcome|AZD2171 (Cediranib Maleate)|
1216328|NCT00243074|O1|Outcome|AZD2171|
1216329|NCT00243074|O1|Outcome|AZD2171|
1216330|NCT00243074|O1|Outcome|AZD2171|
1216331|NCT00243074|O1|Outcome|AZD2171|
1216332|NCT00243074|O1|Outcome|AZD2171 (Cediranib Maleate)|
1216333|NCT00243074|E1|Reported Event|AZD2171|
1216444|NCT00242632|E2|Reported Event|ApoE-e4-|This includes the 11 subjects who were non-carriers of the ApoE-e4 allele.
1216336|NCT00243061|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally"
1216337|NCT00243061|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally"
1216338|NCT00243061|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally"
1216341|NCT00243061|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Correlative studies"
1216342|NCT00243061|E1|Reported Event|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Correlative studies"
1216343|NCT00243022|B3|Baseline|Total|Total of all reporting groups
1216344|NCT00243022|B2|Baseline|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/daygiven orally"
1216345|NCT00243022|B1|Baseline|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
1216346|NCT00243022|P2|Participant Flow|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/day given orally"
1216347|NCT00243022|P1|Participant Flow|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
1216348|NCT00243022|O2|Outcome|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/daygiven orally"
1216349|NCT00243022|O1|Outcome|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
1216350|NCT00243022|O2|Outcome|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/daygiven orally"
1216351|NCT00243022|O1|Outcome|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
1216352|NCT00243022|O2|Outcome|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/daygiven orally"
1216353|NCT00243022|O1|Outcome|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
1216354|NCT00243022|O2|Outcome|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/daygiven orally"
1216355|NCT00243022|O1|Outcome|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
1216356|NCT00243022|O2|Outcome|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/daygiven orally"
1216357|NCT00243022|O1|Outcome|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
1216358|NCT00243022|O2|Outcome|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/daygiven orally"
1216359|NCT00243022|O1|Outcome|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
1216360|NCT00243022|O2|Outcome|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/daygiven orally"
1216361|NCT00243022|O1|Outcome|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
1216362|NCT00243022|E2|Reported Event|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/daygiven orally"
1216363|NCT00243022|E1|Reported Event|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
1216364|NCT00242710|B5|Baseline|Total|Total of all reporting groups
1216365|NCT00242710|B4|Baseline|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216508|NCT00242385|B1|Baseline|Subjects With Severe Congenital α1-PI Deficiency|Subjects were randomized to receive either single dose ARALAST 60 mg/kg or single-dose ARALAST Fr. IV-1 60 mg/kg at 0.2 mL/kg/min during the first treatment period with crossover to the alternate study product during the second treatment period, with a minimum of 7 days between the two treatment periods.
1216366|NCT00242710|B3|Baseline|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216367|NCT00242710|B2|Baseline|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216368|NCT00242710|B1|Baseline|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
1216369|NCT00242710|P4|Participant Flow|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216370|NCT00242710|P3|Participant Flow|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216371|NCT00242710|P2|Participant Flow|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216372|NCT00242710|P1|Participant Flow|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
1216373|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216374|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216375|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216376|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
1216377|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216378|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216379|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216380|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
1216445|NCT00242632|E1|Reported Event|ApoE-e4+|This includes the 11 subjects who were carriers of the ApoE-e4 allele.
1216381|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216382|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216383|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216384|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
1216385|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216386|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216387|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216388|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
1216389|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216390|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216391|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216392|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
1216393|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216394|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216395|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216396|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
1216397|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216446|NCT00242619|B3|Baseline|Total|Total of all reporting groups
1216447|NCT00242619|B2|Baseline|Drop-Outs|Subjects who met all criteria, took rosiglitazone, and did not complete the study.
1216398|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216399|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216400|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
1216401|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216402|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216403|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216404|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
1216405|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216406|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216407|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216408|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
1216409|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216410|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216411|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216412|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
1216413|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216414|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216448|NCT00242619|B1|Baseline|Completers|Subjects who met all criteria, took rosiglitazone, and completed the study.
1217870|NCT00235326|O2|Outcome|Exposed to Gastroenteritis|
1216415|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216416|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
1216417|NCT00242710|E4|Reported Event|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216418|NCT00242710|E3|Reported Event|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216419|NCT00242710|E2|Reported Event|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
1216420|NCT00242710|E1|Reported Event|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
1216421|NCT00242684|B1|Baseline|Transitional Care Unit Veterans|older patients admitted to a TCU unit
1216422|NCT00242684|P1|Participant Flow|Transitional Care Unit Veterans|older patients admitted to a TCU unit
1216423|NCT00242684|O1|Outcome|Transitional Care Unit Veterans|older patients admitted to a TCU unit
1216424|NCT00242684|O1|Outcome|Transitional Care Unit Veterans|older patients admitted to a TCU unit
1216425|NCT00242684|E1|Reported Event|Transitional Care Unit Veterans|older patients admitted to a TCU unit
1216426|NCT00242658|B3|Baseline|Total|Total of all reporting groups
1216427|NCT00242658|B2|Baseline|No Tailored Physical Activity Intervention Group|The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.
1216428|NCT00242658|B1|Baseline|Tailored Physical Activity Intervention Group|The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants’ needs; they also included an activity prescription.
1216429|NCT00242658|P2|Participant Flow|No Tailored Physical Activity Intervention Group|The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.
1216430|NCT00242658|P1|Participant Flow|Tailored Physical Activity Intervention Group|The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants’ needs; they also included an activity prescription.
1216431|NCT00242658|O2|Outcome|No Tailored Physical Activity Intervention Group|The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.
1216432|NCT00242658|O1|Outcome|Tailored Physical Activity Intervention Group|The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants’ needs; they also included an activity prescription.
1216433|NCT00242658|O2|Outcome|No Tailored Physical Activity Intervention Group|The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.
1216434|NCT00242658|O1|Outcome|Tailored Physical Activity Intervention Group|The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants’ needs; they also included an activity prescription.
1216435|NCT00242658|E2|Reported Event|No Tailored Physical Activity Intervention Group|The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.
1216436|NCT00242658|E1|Reported Event|Tailored Physical Activity Intervention Group|The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants’ needs; they also included an activity prescription.
1216437|NCT00242632|B3|Baseline|Total|Total of all reporting groups
1216438|NCT00242632|B2|Baseline|apoE-e4+|Subjects with the apoE-e4 allele
1216439|NCT00242632|B1|Baseline|apoE-e4-|Subjects without the apoE-e4 allele
1216440|NCT00242632|P2|Participant Flow|apoE-e4+|Subjects with the apoE-e4 allele
1216441|NCT00242632|P1|Participant Flow|apoE-e4-|Subjects without the apoE-e4 allele
1216442|NCT00242632|O1|Outcome|T1-T2|This arm includes all 22 subjects from Time 1 to Time 2, a 6-month period.
1216443|NCT00242632|O1|Outcome|T1-T2|This arm includes all 22 subjects from Time 1 to Time 2, a 6-month period.
1216455|NCT00242619|E2|Reported Event|Drop-Outs|Subjects who met all criteria, took rosiglitazone, and did not complete the study.
1216456|NCT00242619|E1|Reported Event|Completers|Subjects who met all criteria, took rosiglitazone, and completed the study.
1216457|NCT00242580|B4|Baseline|Total|Total of all reporting groups
1216509|NCT00242385|P2|Participant Flow|ARALAST Then ARALAST Fr. IV-1|Subjects were randomized to receive either single dose ARALAST 60 mg/kg or single-dose ARALAST Fr. IV-1 60 mg/kg at 0.2 mL/kg/min during the first treatment period with crossover to the alternate study product during the second treatment period, with a minimum of 7 days between the two treatment periods.
1216515|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
1216458|NCT00242580|B3|Baseline|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
1216459|NCT00242580|B2|Baseline|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
1216460|NCT00242580|B1|Baseline|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
1216461|NCT00242580|P3|Participant Flow|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
1216462|NCT00242580|P2|Participant Flow|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
1216463|NCT00242580|P1|Participant Flow|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
1216464|NCT00242580|O3|Outcome|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
1216465|NCT00242580|O2|Outcome|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
1216466|NCT00242580|O1|Outcome|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
1216467|NCT00242580|O3|Outcome|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
1216468|NCT00242580|O2|Outcome|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
1216510|NCT00242385|P1|Participant Flow|ARALAST Fr. IV-1 Then Aralast|Subjects were randomized to receive either single dose ARALAST 60 mg/kg or single-dose ARALAST Fr. IV-1 60 mg/kg at 0.2 mL/kg/min during the first treatment period with crossover to the alternate study product during the second treatment period, with a minimum of 7 days between the two treatment periods.
1216469|NCT00242580|O1|Outcome|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
1216470|NCT00242580|O3|Outcome|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
1216471|NCT00242580|O2|Outcome|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
1216472|NCT00242580|O1|Outcome|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
1216473|NCT00242580|O3|Outcome|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
1216474|NCT00242580|O2|Outcome|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
1216475|NCT00242580|O1|Outcome|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
1216476|NCT00242580|O3|Outcome|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
1216477|NCT00242580|O2|Outcome|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
1216478|NCT00242580|O1|Outcome|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
1216479|NCT00242580|O3|Outcome|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
1216507|NCT00242502|E1|Reported Event|Bevacizumab + Erlotinib|Bevacizumab 10 mg/kg intravenous every 14 days, repeat cycle every 28 days; Erlotinib 150 mg orally every day continuous dosing.
1216574|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
1217176|NCT00237809|O4|Outcome|Placebo/Control|"Placebo/control~Cognitive retraining : video"
1216480|NCT00242580|O2|Outcome|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
1216481|NCT00242580|O1|Outcome|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
1216482|NCT00242580|E3|Reported Event|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
1216483|NCT00242580|E2|Reported Event|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
1216484|NCT00242580|E1|Reported Event|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
1216485|NCT00242567|B3|Baseline|Total|Total of all reporting groups
1216486|NCT00242567|B2|Baseline|Delayed Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
1216487|NCT00242567|B1|Baseline|Early Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
1216488|NCT00242567|P2|Participant Flow|Delayed Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
1216489|NCT00242567|P1|Participant Flow|Early Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
1216490|NCT00242567|O2|Outcome|Delayed Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
1216491|NCT00242567|O1|Outcome|Early Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
1216492|NCT00242567|O2|Outcome|Delayed Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
1216493|NCT00242567|O1|Outcome|Early Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
1216494|NCT00242567|O2|Outcome|Delayed Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
1216495|NCT00242567|O1|Outcome|Early Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
1216496|NCT00242567|O2|Outcome|Delayed Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
1216497|NCT00242567|O1|Outcome|Early Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
1216498|NCT00242567|O2|Outcome|Delayed Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
1216499|NCT00242567|O1|Outcome|Early Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
1216500|NCT00242567|E4|Reported Event|Delayed Group (Zometa)|Delayed Group (Zometa)
1216501|NCT00242567|E3|Reported Event|Delayed Group (No Zometa)|Delayed Group (No Zometa)
1216502|NCT00242567|E2|Reported Event|Delayed Group (Overall)|Delayed Group (Overall)
1216503|NCT00242567|E1|Reported Event|Early Group|Early Group
1216504|NCT00242502|B1|Baseline|Bevacizumab + Erlotinib|Bevacizumab 10 mg/kg intravenous every 14 days, repeat cycle every 28 days; Erlotinib 150 mg orally every day continuous dosing.
1216505|NCT00242502|P1|Participant Flow|Bevacizumab + Erlotinib|Bevacizumab 10 mg/kg intravenous every 14 days, repeat cycle every 28 days; Erlotinib 150 mg orally every day continuous dosing.
1216506|NCT00242502|O1|Outcome|Bevacizumab + Erlotinib|Bevacizumab 10 mg/kg intravenous every 14 days, repeat cycle every 28 days; Erlotinib 150 mg orally every day continuous dosing.
1216516|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
1216517|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
1216518|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
1216519|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
1216520|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
1216521|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
1216522|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
1216523|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
1216524|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
1216525|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
1216526|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
1216527|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
1216528|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
1216529|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
1216530|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
1216531|NCT00242385|E2|Reported Event|ARALAST|Subjects received a single dose of ARALAST 60 mg/kg at 0.2 mL/kg/min
1216532|NCT00242385|E1|Reported Event|ARALAST Fr. IV-1|Subjects received a single dose of ARALAST Fr. IV-1 60 mg/kg at 0.2 mL/kg/min
1216533|NCT00242216|B3|Baseline|Total|Total of all reporting groups
1216534|NCT00242216|B2|Baseline|Fosamprenavir|
1216535|NCT00242216|B1|Baseline|Atazanavir|
1216536|NCT00242216|P2|Participant Flow|Fosamprenavir|Fosamprenavir/ritonavir (1400mg/100mg) once daily
1216537|NCT00242216|P1|Participant Flow|Atazanavir|Atazanavir/ritonavir (300mg/100mg) once daily
1216538|NCT00242216|O2|Outcome|Fosamprenavir|
1216539|NCT00242216|O1|Outcome|Atazanavir|
1216540|NCT00242216|O2|Outcome|Fosamprenavir|
1216541|NCT00242216|O1|Outcome|Atazanavir|
1216542|NCT00242216|E2|Reported Event|Fosamprenavir|
1216543|NCT00242216|E1|Reported Event|Atazanavir|
1216544|NCT00241839|B3|Baseline|Total|Total of all reporting groups
1216545|NCT00241839|B2|Baseline|B (Placebo)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, a Placebo, having the same appearance and dosage label(300mg)as allopurinol, was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional placebo (300mg)was added with total dose of 600mg daily. The dosage of placebo then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
1216546|NCT00241839|B1|Baseline|A (Allopurinol)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Allopurinol 300mg daily was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg allopurinol was added with total dose of 600mg daily. The dosage of allopurinol then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
1216547|NCT00241839|P2|Participant Flow|B(Placebo)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, a Placebo, having the same appearance and dosage label(300mg)as allopurinol, was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional placebo (300mg)was added with total dose of 600mg daily. The dosage of placebo then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
1216548|NCT00241839|P1|Participant Flow|A (Allopurinol)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Allopurinol 300mg daily was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg allopurinol was added with total dose of 600mg daily. The dosage of allopurinol then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
1216572|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
1216573|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
1217871|NCT00235326|O1|Outcome|Unexposed to Gastroenteritis|
1216549|NCT00241839|O2|Outcome|B (Placebo)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Placebo 300mg daily (identical in size, color, and dosage as allopurinol) was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg placebo was added with total dose of 600mg daily. The dosage of placebo then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
1216550|NCT00241839|O1|Outcome|A (Allopurinol)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Allopurinol 300mg daily was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg allopurinol was added with total dose of 600mg daily. The dosage of allopurinol then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
1216551|NCT00241839|O2|Outcome|B (Placebo)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Placebo 300mg daily (identical in size, color, and dosage as allopurinol) was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg placebo was added with total dose of 600mg daily. The dosage of placebo then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
1216552|NCT00241839|O1|Outcome|A (Allopurinol)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Allopurinol 300mg daily was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg allopurinol was added with total dose of 600mg daily. The dosage of allopurinol then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
1216553|NCT00241839|O2|Outcome|B (Placebo)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Placebo 300mg daily (identical in size, color, and dosage as allopurinol) was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg placebo was added with total dose of 600mg daily. The dosage of placebo then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
1216554|NCT00241839|O1|Outcome|A (Allopurinol)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Allopurinol 300mg daily was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg allopurinol was added with total dose of 600mg daily. The dosage of allopurinol then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
1216555|NCT00241839|O2|Outcome|B (Placebo)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Placebo 300mg daily (identical in size, color, and dosage as allopurinol) was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg placebo was added with total dose of 600mg daily. The dosage of placebo then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
1216556|NCT00241839|O1|Outcome|A (Allopurinol)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Allopurinol 300mg daily was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg allopurinol was added with total dose of 600mg daily. The dosage of allopurinol then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
1216557|NCT00241839|E2|Reported Event|B (Placebo)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Placebo 300mg daily (identical in size, color, and dosage as allopurinol) was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg placebo was added with total dose of 600mg daily. The dosage of placebo then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
1216558|NCT00241839|E1|Reported Event|A (Allopurinol)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Allopurinol 300mg daily was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg allopurinol was added with total dose of 600mg daily. The dosage of allopurinol then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
1216559|NCT00241644|B5|Baseline|Total|Total of all reporting groups
1216560|NCT00241644|B4|Baseline|Rotarix Pooled Group|Subjects received 2 or 3 doses of Rotarix™ (rotavirus vaccine).
1216561|NCT00241644|B3|Baseline|Placebo Group|Subjects received 3 doses of placebo.
1216562|NCT00241644|B2|Baseline|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
1216563|NCT00241644|B1|Baseline|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
1216564|NCT00241644|P4|Participant Flow|Rotarix Pooled Group|Subjects received 2 or 3 doses of Rotarix™ (rotavirus vaccine).
1216565|NCT00241644|P3|Participant Flow|Placebo Group|Subjects received 3 doses of placebo.
1216566|NCT00241644|P2|Participant Flow|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
1216567|NCT00241644|P1|Participant Flow|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
1216568|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
1216569|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
1216570|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
1216571|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
1216575|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
1216576|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
1216577|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
1216578|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
1216579|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
1216580|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
1216581|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
1216582|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
1216583|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
1216584|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
1216585|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
1228529|NCT00165646|B1|Baseline|Placebo|once daily orally for 4 weeks
1216586|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
1216587|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
1216588|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
1216589|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
1216590|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
1216591|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
1216592|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
1216593|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
1216594|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
1216595|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
1216596|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
1216597|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
1216598|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
1216599|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
1216600|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
1216601|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
1216602|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
1216603|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
1216604|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
1216605|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
1216606|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
1216607|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
1216608|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
1216609|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
1216610|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
1216611|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
1216612|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
1216613|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
1216614|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
1216615|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
1216616|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
1216617|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
1216618|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
1216619|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
1216620|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
1216621|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
1216622|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
1216623|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
1216624|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
1216695|NCT00241176|B1|Baseline|Sample|Sample of children and adolescents that enrolled in study to receive active medication. This was not a placebo controlled study.
1216625|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
1216626|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
1216627|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
1216628|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
1216629|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
1216630|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
1216631|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
1216632|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
1216633|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
1216634|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
1217187|NCT00237809|E1|Reported Event|D-serine/Control|"D-serine/control~D-serine : D-serine (30 mg/kg)"
1216635|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
1216636|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
1216637|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
1216638|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
1216639|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
1216640|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
1216641|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
1216642|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
1216643|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
1216644|NCT00241644|E4|Reported Event|Placebo Group|Subjects received 3 doses of placebo.
1216645|NCT00241644|E3|Reported Event|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
1216646|NCT00241644|E2|Reported Event|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
1216647|NCT00241644|E1|Reported Event|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
1216648|NCT00241358|B4|Baseline|Total|Total of all reporting groups
1216649|NCT00241358|B3|Baseline|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis~Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
1216650|NCT00241358|B2|Baseline|Recipients|"Conditioning Regimen~Cyclophosphamide 60mg/kg/day on Days -3 and -2~TBI 550cGy on Day -1~GVHD prophylaxis~*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100~PBSC transplant on Day 0"
1216651|NCT00241358|B1|Baseline|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
1216652|NCT00241358|P3|Participant Flow|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis~Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
1216653|NCT00241358|P2|Participant Flow|Recipients|"Conditioning Regimen~Cyclophosphamide 60mg/kg/day on Days -3 and -2~TBI 550cGy on Day -1~GVHD prophylaxis~*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100~PBSC transplant on Day 0"
1216654|NCT00241358|P1|Participant Flow|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
1216655|NCT00241358|O3|Outcome|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis~Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
1216656|NCT00241358|O2|Outcome|Recipients|"Conditioning Regimen~Cyclophosphamide 60mg/kg/day on Days -3 and -2~TBI 550cGy on Day -1~GVHD prophylaxis~*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100~PBSC transplant on Day 0"
1216657|NCT00241358|O1|Outcome|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
1216658|NCT00241358|O3|Outcome|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis~Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
1216659|NCT00241358|O2|Outcome|Recipients|"Conditioning Regimen~Cyclophosphamide 60mg/kg/day on Days -3 and -2~TBI 550cGy on Day -1~GVHD prophylaxis~*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100~PBSC transplant on Day 0"
1216660|NCT00241358|O1|Outcome|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
1216661|NCT00241358|O3|Outcome|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis~Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
1218548|NCT00230737|E2|Reported Event|B: High Dose|Melatonin 4.0 mg
1216662|NCT00241358|O2|Outcome|Recipients|"Conditioning Regimen~Cyclophosphamide 60mg/kg/day on Days -3 and -2~TBI 550cGy on Day -1~GVHD prophylaxis~*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100~PBSC transplant on Day 0"
1216663|NCT00241358|O1|Outcome|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
1216664|NCT00241358|O3|Outcome|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis~Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
1216665|NCT00241358|O2|Outcome|Recipients|"Conditioning Regimen~Cyclophosphamide 60mg/kg/day on Days -3 and -2~TBI 550cGy on Day -1~GVHD prophylaxis~*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100~PBSC transplant on Day 0"
1216666|NCT00241358|O1|Outcome|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
1217188|NCT00237796|B3|Baseline|Total|Total of all reporting groups
1216667|NCT00241358|O3|Outcome|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis~Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
1216668|NCT00241358|O2|Outcome|Recipients|"Conditioning Regimen~Cyclophosphamide 60mg/kg/day on Days -3 and -2~TBI 550cGy on Day -1~GVHD prophylaxis~*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100~PBSC transplant on Day 0"
1216669|NCT00241358|O1|Outcome|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
1216670|NCT00241358|O3|Outcome|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis~Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
1216671|NCT00241358|O2|Outcome|Recipients|"Conditioning Regimen~Cyclophosphamide 60mg/kg/day on Days -3 and -2~TBI 550cGy on Day -1~GVHD prophylaxis~*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100~PBSC transplant on Day 0"
1216672|NCT00241358|O1|Outcome|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
1216673|NCT00241358|O3|Outcome|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis~Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
1216674|NCT00241358|O2|Outcome|Recipients|"Conditioning Regimen~Cyclophosphamide 60mg/kg/day on Days -3 and -2~TBI 550cGy on Day -1~GVHD prophylaxis~*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100~PBSC transplant on Day 0"
1216675|NCT00241358|O1|Outcome|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
1216676|NCT00241358|O3|Outcome|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis~Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
1216677|NCT00241358|O2|Outcome|Recipients|"Conditioning Regimen~Cyclophosphamide 60mg/kg/day on Days -3 and -2~TBI 550cGy on Day -1~GVHD prophylaxis~*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100~PBSC transplant on Day 0"
1216678|NCT00241358|O1|Outcome|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
1216679|NCT00241358|O3|Outcome|Intravenous (IV) Treatment Plan - Donor|"Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis~Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
1216680|NCT00241358|O2|Outcome|Recipients|"Conditioning Regimen~Cyclophosphamide 60mg/kg/day on Days -3 and -2~TBI 550cGy on Day -1~GVHD prophylaxis~*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100~PBSC transplant on Day 0"
1216681|NCT00241358|O1|Outcome|Subcutaneous (SC) Treatment Plan - Donor|"Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis~If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3."
1216682|NCT00241358|E2|Reported Event|Recipients|Stem Cell Transplantation Day 0
1216683|NCT00241358|E1|Reported Event|Donors|AMD3100 SC 240 ug/kg/actual donor weight on Day 1 and possibly Day 3
1216684|NCT00241280|B3|Baseline|Total|Total of all reporting groups
1216685|NCT00241280|B2|Baseline|Test: Galyfilcon A|Subjects that were randomized to receive the Test lens galyfilcon A
1216686|NCT00241280|B1|Baseline|Control: Etafilcon A|Subjects that were randomized to receive the Control lens etafilcon A
1216687|NCT00241280|P2|Participant Flow|Test: Galyfilcon A|Subjects that were randomly assigned to wear the Test lens.
1216688|NCT00241280|P1|Participant Flow|Control: Etafilcon A|Subjects that were randomly assigned to wear Control lens.
1216689|NCT00241280|O2|Outcome|Test: Galyfilcon A|Subjects that were randomly assigned to wear the Test lens.
1216690|NCT00241280|O1|Outcome|Control: Etafilcon A|Subjects that were randomly assigned to wear the Control lens.
1216691|NCT00241280|O2|Outcome|Test: Galyfilcon A|"Subjects that were randomly assigned to wear the Test lens.~It was reported that for one subject eye, that the contact lens was dirty during the visual acuity testing."
1216692|NCT00241280|O1|Outcome|Control: Etafilcon A|Subjects that were randomly assigned to wear the Control lens.
1216693|NCT00241280|E2|Reported Event|Test: Galyfilcon A|Subjects that were randomly assigned to wear Test lens.
1216694|NCT00241280|E1|Reported Event|Control: Etafilcon A|Subjects that were randomly assigned to wear Control lens.
1216696|NCT00241176|P1|Participant Flow|Aripiprazole|Subjects received initial dose based on body weight at Visit 2: Subjects between 25-50 kg were started on 1.25 mg/day, Subjects between 50-70 kg were started on 2.5 mg/day, Subjects greater than 70 kg were started on 5 mg/day. Dosage was titrated at Visit 3, 5, 6, or 7 based on YGTSS and CGI-TS ratings at the discretion of the investigator. Subjects who showed evidence of response (reduction in CGI-TS by 1-2 points)remained on the same dose. Subjects who did not show evidence of response could be increased: Subjects between 25-50 kg were could be increased 1.25 mg/day at each titration visit, Subjects between 50-70 kg could be increased 2.5 mg/day at each titration visit, and Subjects greater than 70 kg could be increased 5 mg/day at each titration visit.
1216697|NCT00241176|O2|Outcome|Group 1 - Endpoint|Sample of children and adolescents that enrolled in study to receive active medication at endpoint prior to down titration.
1216698|NCT00241176|O1|Outcome|Group 1 - Baseline|Sample of children and adolescents that enrolled in study to receive active medication at baseline.
1216699|NCT00241176|O2|Outcome|Group 1 - Endpoint|Sample of children and adolescents that enrolled in study to receive active medication at endpoint prior to down titration.
1216700|NCT00241176|O1|Outcome|Group 1 - Baseline|Sample of children and adolescents that enrolled in study to receive active medication at baseline.
1216701|NCT00241176|E1|Reported Event|Sample|Sample of children and adolescents that enrolled in study to receive active medication. This was not a placebo controlled study.
1216702|NCT00240994|B1|Baseline|Alemtuzumab (Campath)|In this open-label, single-arm trial, participants were administered a 0.3 mg/kg dose of alemtuzumab intravenously one day prior to kidney transplantation and one day post kidney transplantation. Participants were then administered a maintenance immunosuppressive regimen of tacrolimus and mycophenolate mofetil (MMF) for 8 to 12 weeks, followed by sirolimus and MMF until 24 months post transplantation.
1216703|NCT00240994|P1|Participant Flow|Alemtuzumab (Campath)|In this open-label, single-arm trial, participants were administered a 0.3 mg/kg dose of alemtuzumab intravenously one day prior to kidney transplantation and one day post kidney transplantation. Participants were then administered a maintenance immunosuppressive regimen of tacrolimus and mycophenolate mofetil (MMF) for 8 to 12 weeks, followed by sirolimus and MMF until 24 months post transplantation.
1216704|NCT00240994|O1|Outcome|Alemtuzumab (Campath)|In this open-label, single-arm trial, participants were administered a 0.3 mg/kg dose of alemtuzumab intravenously one day prior to kidney transplantation and one day post kidney transplantation. Participants were then administered a maintenance immunosuppressive regimen of tacrolimus and mycophenolate mofetil (MMF) for 8 to 12 weeks, followed by sirolimus and MMF until 24 months post transplantation.
1216705|NCT00240994|E1|Reported Event|Alemtuzumab (Campath)|In this open-label, single-arm trial , participants were administered a 0.3 mg/kg dose of alemtuzumab intravenously one day prior to kidney transplantation and one day post kidney transplantation. Participants were then administered a maintenance immunosuppressive regimen of tacrolimus and mycophenolate mofetil (MMF) for 8 to 12 weeks, followed by sirolimus and MMF until 24 months post transplantation.
1216706|NCT00240981|B3|Baseline|Total|Total of all reporting groups
1216707|NCT00240981|B2|Baseline|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
1216708|NCT00240981|B1|Baseline|Treatment|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
1216709|NCT00240981|P2|Participant Flow|Placebo|
1216710|NCT00240981|P1|Participant Flow|Treatment|
1216711|NCT00240981|O2|Outcome|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
1216712|NCT00240981|O1|Outcome|Testosterone|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
1216713|NCT00240981|O2|Outcome|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
1216714|NCT00240981|O1|Outcome|Treatment|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
1216715|NCT00240981|O2|Outcome|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
1216716|NCT00240981|O1|Outcome|Treatment|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
1216717|NCT00240981|O2|Outcome|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
1216718|NCT00240981|O1|Outcome|Treatment|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
1216719|NCT00240981|O2|Outcome|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
1216720|NCT00240981|O1|Outcome|Treatment|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
1216721|NCT00240981|O2|Outcome|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
1216722|NCT00240981|O1|Outcome|Testosterone|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
1216723|NCT00240981|O2|Outcome|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
1216724|NCT00240981|O1|Outcome|Treatment|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
1216725|NCT00240981|O2|Outcome|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
1216726|NCT00240981|O1|Outcome|Treatment|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
1216727|NCT00240981|O2|Outcome|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
1216763|NCT00240526|P4|Participant Flow|Engerix 3D Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
1216728|NCT00240981|O1|Outcome|Treatment|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
1216729|NCT00240981|O2|Outcome|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
1216730|NCT00240981|O1|Outcome|Treatment|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
1216731|NCT00240981|E2|Reported Event|Placebo|Topical gel (placebo formulation): Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.
1216732|NCT00240981|E1|Reported Event|Treatment|Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
1216733|NCT00240539|B5|Baseline|Total|Total of all reporting groups
1216734|NCT00240539|B4|Baseline|HBsAg(-) & HBeAg(-) 4-dose Group|Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
1216735|NCT00240539|B3|Baseline|HBsAg(+) & HBeAg(+) 4-dose Group|Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
1216736|NCT00240539|B2|Baseline|HBsAg(+) & HBeAg(-) 4-dose Group|Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study.
1216737|NCT00240539|B1|Baseline|HBsAg(+) & HBeAg(+) 5-dose Group|Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study.
1216738|NCT00240539|P4|Participant Flow|HBsAg(-) & HBeAg(-) 4-dose Group|Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
1216739|NCT00240539|P3|Participant Flow|HBsAg(+) & HBeAg(+) 4-dose Group|Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
1216740|NCT00240539|P2|Participant Flow|HBsAg(+) & HBeAg(-) 4-dose Group|Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study.
1216741|NCT00240539|P1|Participant Flow|HBsAg(+) & HBeAg(+) 5-dose Group|Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study.
1216742|NCT00240539|O4|Outcome|HBsAg(-) & HBeAg(-) 4-dose Group|Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
1216743|NCT00240539|O3|Outcome|HBsAg(+) & HBeAg(+) 4-dose Group|Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
1216744|NCT00240539|O2|Outcome|HBsAg(+) & HBeAg(-) 4-dose Group|Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study.
1216745|NCT00240539|O1|Outcome|HBsAg(+) & HBeAg(+) 5-dose Group|Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study.
1216746|NCT00240539|O4|Outcome|HBsAg(-) & HBeAg(-) 4-dose Group|Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
1216747|NCT00240539|O3|Outcome|HBsAg(+) & HBeAg(+) 4-dose Group|Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
1216748|NCT00240539|O2|Outcome|HBsAg(+) & HBeAg(-) 4-dose Group|Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study.
1216749|NCT00240539|O1|Outcome|HBsAg(+) & HBeAg(+) 5-dose Group|Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study.
1216750|NCT00240539|O4|Outcome|HBsAg(-) & HBeAg(-) 4-dose Group|Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
1216751|NCT00240539|O3|Outcome|HBsAg(+) & HBeAg(+) 4-dose Group|Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
1216752|NCT00240539|O2|Outcome|HBsAg(+) & HBeAg(-) 4-dose Group|Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study.
1216753|NCT00240539|O1|Outcome|HBsAg(+) & HBeAg(+) 5-dose Group|Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study.
1216754|NCT00240539|E4|Reported Event|HBsAg(-) & HBeAg(-) 4-dose Group|Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
1216755|NCT00240539|E3|Reported Event|HBsAg(+) & HBeAg(+) 4-dose Group|Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
1216756|NCT00240539|E2|Reported Event|HBsAg(+) & HBeAg(-) 4-dose Group|Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study.
1216976|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216757|NCT00240539|E1|Reported Event|HBsAg(+) & HBeAg(+) 5-dose Group|Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study.
1216758|NCT00240526|B5|Baseline|Total|Total of all reporting groups
1216759|NCT00240526|B4|Baseline|Engerix 3D Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
1216760|NCT00240526|B3|Baseline|Engerix 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
1216761|NCT00240526|B2|Baseline|Engerix 3D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
1216762|NCT00240526|B1|Baseline|Engerix 4D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
1217488|NCT00236080|O1|Outcome|PROVIGIL 200 mg/Day|PROVIGIL 200 mg once daily only on nights worked
1216764|NCT00240526|P3|Participant Flow|Engerix 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
1216765|NCT00240526|P2|Participant Flow|Engerix 3D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
1216766|NCT00240526|P1|Participant Flow|Engerix 4D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
1216767|NCT00240526|O4|Outcome|Engerix 3D Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
1216768|NCT00240526|O3|Outcome|Engerix 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
1216769|NCT00240526|O2|Outcome|Engerix 3D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
1216770|NCT00240526|O1|Outcome|Engerix 4D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
1216771|NCT00240526|O4|Outcome|Engerix 3D Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
1216772|NCT00240526|O3|Outcome|Engerix 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
1216773|NCT00240526|O2|Outcome|Engerix 3D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
1216774|NCT00240526|O1|Outcome|Engerix 4D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
1216775|NCT00240526|O4|Outcome|ENGERIX 3D GROUP|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
1216776|NCT00240526|O3|Outcome|ENGERIX 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
1216777|NCT00240526|O2|Outcome|ENGERIX 3D + HBIG GROUP|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
1216778|NCT00240526|O1|Outcome|ENGERIX 4D + HBIG GROUP|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
1216779|NCT00240526|O4|Outcome|Engerix 3D Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
1216780|NCT00240526|O3|Outcome|Engerix 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
1216781|NCT00240526|O2|Outcome|Engerix 3D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
1216782|NCT00240526|O1|Outcome|Engerix 4D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
1216783|NCT00240526|O4|Outcome|ENGERIX 3D GROUP|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
1216784|NCT00240526|O3|Outcome|ENGERIX 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
1216785|NCT00240526|O2|Outcome|ENGERIX 3D + HBIG GROUP|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
1216786|NCT00240526|O1|Outcome|ENGERIX 4D + HBIG GROUP|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
1216787|NCT00240526|O4|Outcome|Engerix 3D Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
1216788|NCT00240526|O3|Outcome|Engerix 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
1216789|NCT00240526|O2|Outcome|Engerix 3D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
1216790|NCT00240526|O1|Outcome|Engerix 4D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
1216791|NCT00240526|E4|Reported Event|Engerix 3D Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
1216792|NCT00240526|E3|Reported Event|Engerix 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
1216793|NCT00240526|E2|Reported Event|Engerix 3D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
1216794|NCT00240526|E1|Reported Event|Engerix 4D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
1216795|NCT00240500|B7|Baseline|Total|Total of all reporting groups
1217177|NCT00237809|O3|Outcome|D-serine/Cog Rehab|"D-serine/cog rehab~D-serine : D-serine (30 mg/kg)"
1216796|NCT00240500|B6|Baseline|HBV 6 Group|neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
1216797|NCT00240500|B5|Baseline|HBV 3 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
1216798|NCT00240500|B4|Baseline|HBV 4 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
1216799|NCT00240500|B3|Baseline|HBV 1 Group|neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
1216800|NCT00240500|B2|Baseline|HBV 2 Group|neonates born to Hepatitis B surface antigen positive (HBsAg+) and Hepatitis B e antigen positive (HBeAg+) mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
1217489|NCT00236080|O5|Outcome|Placebo|Matching placebo tablets once daily only on nights worked
1216801|NCT00240500|B1|Baseline|HBV 5 Group|neonates born to Hepatitis B surface antigen negative (HBsAg-) and Hepatitis B e antigen negative (HBeAg-) mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
1216802|NCT00240500|P6|Participant Flow|HBV 6 Group|neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
1216803|NCT00240500|P5|Participant Flow|HBV 3 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
1216804|NCT00240500|P4|Participant Flow|HBV 4 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
1216805|NCT00240500|P3|Participant Flow|HBV 1 Group|neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
1216806|NCT00240500|P2|Participant Flow|HBV 2 Group|neonates born to Hepatitis B surface antigen positive (HBsAg+) and Hepatitis B e antigen positive (HBeAg+) mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
1216807|NCT00240500|P1|Participant Flow|HBV 5 Group|neonates born to Hepatitis B surface antigen negative (HBsAg-) and Hepatitis B e antigen negative (HBeAg-) mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
1216808|NCT00240500|O6|Outcome|HBV 6 Group|neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
1216809|NCT00240500|O5|Outcome|HBV 3 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
1216810|NCT00240500|O4|Outcome|HBV 4 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
1216811|NCT00240500|O3|Outcome|HBV 1 Group|neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
1216812|NCT00240500|O2|Outcome|HBV 2 Group|neonates born to Hepatitis B surface antigen positive (HBsAg+) and Hepatitis B e antigen positive (HBeAg+) mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
1216813|NCT00240500|O1|Outcome|HBV 5 Group|neonates born to Hepatitis B surface antigen negative (HBsAg-) and Hepatitis B e antigen negative (HBeAg-) mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
1216814|NCT00240500|O6|Outcome|HBV 6 Group|neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
1216815|NCT00240500|O5|Outcome|HBV 3 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
1216816|NCT00240500|O4|Outcome|HBV 4 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
1216817|NCT00240500|O3|Outcome|HBV 1 Group|neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
1216818|NCT00240500|O2|Outcome|HBV 2 Group|neonates born to Hepatitis B surface antigen positive (HBsAg+) and Hepatitis B e antigen positive (HBeAg+) mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
1216819|NCT00240500|O1|Outcome|HBV 5 Group|neonates born to Hepatitis B surface antigen negative (HBsAg-) and Hepatitis B e antigen negative (HBeAg-) mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
1216820|NCT00240500|O6|Outcome|HBV 6 Group|neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
1216821|NCT00240500|O5|Outcome|HBV 3 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
1216822|NCT00240500|O4|Outcome|HBV 4 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
1216823|NCT00240500|O3|Outcome|HBV 1 Group|neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
1216824|NCT00240500|O2|Outcome|HBV 2 Group|neonates born to Hepatitis B surface antigen positive (HBsAg+) and Hepatitis B e antigen positive (HBeAg+) mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
1216825|NCT00240500|O1|Outcome|HBV 5 Group|neonates born to Hepatitis B surface antigen negative (HBsAg-) and Hepatitis B e antigen negative (HBeAg-) mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
1216826|NCT00240487|B3|Baseline|Total|Total of all reporting groups
1218549|NCT00230737|E1|Reported Event|A: Low Dose|Melatonin 0.4 mg
1216827|NCT00240487|B2|Baseline|Delayed Nitric Oxide|Subjects received no intervention (no nitric oxide) for the first 4 hours of study participation. After which, they received 10 ppm nitric oxide for the next 4 hours of study participation. After the initial 8 hours of study participation, subjects will remain on whichever intervention (no nitric oxide versus 10 ppm nitric oxide) they responded best to.
1216828|NCT00240487|B1|Baseline|Nitric Oxide First|Subjects received 10 ppm nitric oxide for the first 4 hours of study participation After which, the NO was turned off and subjects received no intervention (no nitric oxide) for the next 4 hours of study participation. After the initial 8 hours of study participation, subjects will remain on whichever intervention (no nitric oxide versus 10 ppm nitric oxide) they responded best to.
1216889|NCT00240097|E1|Reported Event|Regimen A First Cycle|Regimen A Irinotecan (I.V.) 150-200 mg/m2; Day 1 (every 5 weeks) Oxaliplatin (I.V.) 85 mg/m2; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 1 (every 5 weeks)
1216829|NCT00240487|P2|Participant Flow|Delayed Nitric Oxide|Subjects who were randomized to receive delayed treatment with Nitric Oxide (NO) began the first 4 hours of study participation receiving no intervention (no nitric oxide). Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the NO was turned on and subjects received 10 ppm of nitric oxide for the next 4 hours of study participation. Blood gases were monitored once an hour for 4 hours.
1216830|NCT00240487|P1|Participant Flow|Nitric Oxide First|Subjects who were randomized to receive Nitric Oxide (NO) began receiving NO immediately after study entry, given at 10 parts per million (ppm) for the first 4 hours of study participation. Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the NO was turned off and subjects received no intervention (no nitric oxide) for the next 4 hours of study participation. Blood gases were monitored once an hour for 4 hours. After the initial 8 hours of study participation, subjects remained on whichever intervention (no intervention versus 10 ppm nitric oxide) they responded best to.
1216831|NCT00240487|O2|Outcome|Delayed Nitric Oxide Treatment|Subjects who were randomized to receive delayed treatment with Nitric Oxide (NO) began the first 4 hours of study participation receiving no intervention (no nitric oxide). During this time, all subjects received standard clinical care. Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the nitric oxide (NO) was turned on and subjects received 10 ppm of nitric oxide for the next 4 hours of study participation. Blood gases were monitored once an hour for 4 hours.
1216832|NCT00240487|O1|Outcome|Immediate Nitric Oxide Treatment|Subjects who were randomized to receive immediate treatment with nitric oxide (NO) began receiving NO immediately after study entry, given at 10 parts per million (ppm) for the first 4 hours of study participation. Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the nitric oxide (NO) was turned off and subjects received no intervention (no nitric oxide) for the next 4 hours of study participation. During this time, all subjects received treatment standard clinical care. Blood gases were monitored once an hour for 4 hours.
1216833|NCT00240487|E2|Reported Event|Delayed Treatment With Nitric Oxide|Subjects who were randomized to receive delayed treatment with Nitric Oxide (NO) began the first 4 hours of study participation receiving no intervention (no nitric oxide). During this time, all subjects received standard clinical care. Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the NO was turned on and subjects received 10 ppm of nitric oxide for the next 4 hours of study participation. Blood gases were monitored once an hour for 4 hours.
1216834|NCT00240487|E1|Reported Event|Immediate Treatment With Nitric Oxide|Subjects who were randomized to receive immediate treatment with nitric oxide (NO) began receiving NO immediately after study entry, given at 10 parts per million (ppm) for the first 4 hours of study participation. Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the nitric oxide (NO) was turned off and subjects received no intervention (no nitric oxide) for the next 4 hours of study participation. During this time, all subjects received standard clinical care. Blood gases were monitored once an hour for 4 hours.
1216835|NCT00240331|B3|Baseline|Total|Total of all reporting groups
1216836|NCT00240331|B2|Baseline|Placebo|Matching placebo
1216837|NCT00240331|B1|Baseline|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
1216838|NCT00240331|P2|Participant Flow|Placebo|Matching placebo
1216839|NCT00240331|P1|Participant Flow|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
1216840|NCT00240331|O2|Outcome|Placebo|Matching placebo
1216841|NCT00240331|O1|Outcome|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
1216842|NCT00240331|O2|Outcome|Placebo|Matching placebo
1216843|NCT00240331|O1|Outcome|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
1216844|NCT00240331|O2|Outcome|Placebo|Matching placebo
1216845|NCT00240331|O1|Outcome|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
1216846|NCT00240331|O2|Outcome|Placebo|Matching placebo
1216847|NCT00240331|O1|Outcome|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
1216848|NCT00240331|O2|Outcome|Placebo|Matching placebo
1216849|NCT00240331|O1|Outcome|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
1216850|NCT00240331|O2|Outcome|Placebo|Matching placebo
1216851|NCT00240331|O1|Outcome|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
1216852|NCT00240331|O2|Outcome|Placebo|Matching placebo
1216853|NCT00240331|O1|Outcome|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
1216854|NCT00240331|E2|Reported Event|Placebo|Matching placebo
1216855|NCT00240331|E1|Reported Event|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
1216856|NCT00240227|B1|Baseline|All Study Paricipants|"Placebo no active medication~placebo~Prazosin~FDA approved medication for hypertension"
1216857|NCT00240227|P1|Participant Flow|All Study Participants|"Placebo no active medication~placebo~Prazosin flexible dose titration up to 12 mg per day.~Prazosin: FDA approved medication for hypertension"
1216858|NCT00240227|O2|Outcome|Prazosin|"Prazosin flexible dose titration up to 12 mg per day.~Prazosin: FDA approved medication for hypertension"
1216859|NCT00240227|O1|Outcome|Placebo|"Placebo no active medication~placebo"
1216860|NCT00240227|E2|Reported Event|Prazosin|"Prazosin flexible dose titration up to 12 mg per day.~Prazosin: FDA approved medication for hypertension"
1216861|NCT00240227|E1|Reported Event|Placebo|"Placebo no active medication~placebo"
1216886|NCT00240097|E4|Reported Event|Regimen B Overall Toxicity|Regimen B Etoposide (I.V.) 100 mg/m2; Day 1, 2, 3 (every 5 weeks) Carboplatin (I.V.) AUC 6; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 4 (every 5 weeks)
1217178|NCT00237809|O2|Outcome|Placebo/Cog Rehab|"Placebo/cog rehab~Cognitive retraining : Cog rehab"
1216862|NCT00240162|B1|Baseline|PTK787/ZK 222584|Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
1216890|NCT00240071|B1|Baseline|Avastin(Bevacizumab) Plus Hormonal Therapy|Avastin (Bevacizumab)15mg/m2 IV every 3 weeks plus various daily oral hormonal therapies.
1216983|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216863|NCT00240162|P1|Participant Flow|PTK787/ZK 222584|Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
1216864|NCT00240162|O1|Outcome|PTK787/ZK 222584|Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
1216865|NCT00240162|O1|Outcome|PTK787/ZK 222584|Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
1216866|NCT00240162|O1|Outcome|PTK787/ZK 222584|Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
1216867|NCT00240162|O1|Outcome|PTK787/ZK 222584|Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
1216868|NCT00240162|E1|Reported Event|PTK787/ZK 222584|Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
1216869|NCT00240110|B3|Baseline|Total|Total of all reporting groups
1216870|NCT00240110|B2|Baseline|Lithium Carbonate Add on Valproate|Lithium carbonate started with titration to achieve blood levels within the therapeutic range and then participants randomized to valproate
1216871|NCT00240110|B1|Baseline|Lithium Carbonate Add on Placebo|Lithium carbonate started with titration to achieve blood levels within the therapeutic range and then participants randomized to placebo
1216872|NCT00240110|P2|Participant Flow|Lithium Carbonate Add on Valproate|Lithium carbonate started and participants randomized to valproate
1216873|NCT00240110|P1|Participant Flow|Lithium Carbonate Add on Placebo|Lithium started and then participants randomized to placebo
1216874|NCT00240110|O2|Outcome|Lithium Carbonate Add on Valproate|Open label lithium carbonate as standard treatment and double blinded valproate
1216875|NCT00240110|O1|Outcome|Lithium Carbonate Add on Placebo|Open label lithium carbonate as standard treatment and double blinded placebo
1216876|NCT00240110|O2|Outcome|Lithium Carbonate Add on Valproate|Lithium carbonate started with titration to achieve blood levels within the therapeutic range and then participants randomized to valproate
1216877|NCT00240110|O1|Outcome|Lithium Carbonate Add on Placebo|Lithium carbonate started with titration to achieve blood levels within the therapeutic range and then participants randomized to placebo
1216878|NCT00240110|E2|Reported Event|Lithium Carbonate Add on Valproate|Lithium carbonate as standard treatment add on double blind valproate
1216879|NCT00240110|E1|Reported Event|Lithium Carbonate Add on Placebo|Lithium carbonate as standard treatment add on double blind placebo
1216880|NCT00240097|B1|Baseline|Regimen A and B|Chemotherapy-naive patients with extensive SCLC will be treated in one of two regimens: Regimen A consists of treatment with irinotecan and oxaliplatin given every 2 weeks while Regimen B consists of etoposide and carboplatin given every 3 weeks. Both regimens will include re-evaluation for response at least every 8 weeks.
1216881|NCT00240097|P1|Participant Flow|Regimen A and B|"Regimen A Irinotecan (I.V.) 150-200 mg/m2; Day 1 (every 5 weeks) Oxaliplatin (I.V.) 85 mg/m2; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 1 (every 5 weeks)~Regimen B Etoposide (I.V.) 100 mg/m2; Day 1, 2, 3 (every 5 weeks) Carboplatin (I.V.) AUC 6; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 4 (every 5 weeks)"
1216882|NCT00240097|O1|Outcome|Part II - After Relapse|Study dosing with A and B based on relapse
1216883|NCT00240097|O1|Outcome|Regimen A and B|Chemotherapy-naive patients with extensive SCLC will be treated in one of two regimens: Regimen A consists of treatment with irinotecan and oxaliplatin given every 2 weeks while Regimen B consists of etoposide and carboplatin given every 3 weeks. Both regimens will include re-evaluation for response at least every 8 weeks
1216884|NCT00240097|O1|Outcome|Regimen A and B|Chemotherapy-naive patients with extensive SCLC will be treated in one of two regimens: Regimen A consists of treatment with irinotecan and oxaliplatin given every 2 weeks while Regimen B consists of etoposide and carboplatin given every 3 weeks. Both regimens will include re-evaluation for response at least every 8 weeks
1216885|NCT00240097|O1|Outcome|Regimen A and B|Chemotherapy-naive patients with extensive SCLC will be treated in one of two regimens: Regimen A consists of treatment with irinotecan and oxaliplatin given every 2 weeks while Regimen B consists of etoposide and carboplatin given every 3 weeks. Both regimens will include re-evaluation for response at least every 8 weeks
1216887|NCT00240097|E3|Reported Event|Regimen A Overall Toxicity|Regimen A Irinotecan (I.V.) 150-200 mg/m2; Day 1 (every 5 weeks) Oxaliplatin (I.V.) 85 mg/m2; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 1 (every 5 weeks)
1216888|NCT00240097|E2|Reported Event|Regimen B First Cycle|Regimen B Etoposide (I.V.) 100 mg/m2; Day 1, 2, 3 (every 5 weeks) Carboplatin (I.V.) AUC 6; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 4 (every 5 weeks)
1230710|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
1216891|NCT00240071|P1|Participant Flow|Avastin(Bevacizumab) Plus Hormonal Therapy|Avastin (Bevacizumab)15mg/m2 IV every 3 weeks plus various daily oral hormonal therapies.
1216892|NCT00240071|O1|Outcome|Avastin (Bevacizumab) Plus Hormone|All patients received Avastin (Bevacizumab) 15 mg/kg IV every three weeks as well as continuing with hormonal therapy they previously were taking.
1216893|NCT00240071|E1|Reported Event|Avastin(Bevacizumab) Plus Hormonal Therapy|Avastin (Bevacizumab)15mg/m2 IV every 3 weeks plus various daily oral hormonal therapies.
1216894|NCT00239928|B1|Baseline|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
1216895|NCT00239928|P1|Participant Flow|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
1216896|NCT00239928|O1|Outcome|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
1216897|NCT00239928|O1|Outcome|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
1216898|NCT00239928|O1|Outcome|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
1216899|NCT00239928|O1|Outcome|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
1216900|NCT00239928|O1|Outcome|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
1216901|NCT00239928|O1|Outcome|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
1216902|NCT00239928|O1|Outcome|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
1216903|NCT00239928|E1|Reported Event|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
1216904|NCT00239837|B3|Baseline|Total|Total of all reporting groups
1216905|NCT00239837|B2|Baseline|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
1216906|NCT00239837|B1|Baseline|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
1216907|NCT00239837|P2|Participant Flow|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
1216908|NCT00239837|P1|Participant Flow|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
1216909|NCT00239837|O2|Outcome|Foster Care Services as Usual|Foster Care Services as Usual: Participants continue with usual foster care
1216971|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216972|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216973|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216910|NCT00239837|O1|Outcome|Middle School Success Intervention (MSS)|"Middle School Success Intervention (MSS): Participants receive the preventative intervention~Middle School Success Intervention (MSS): This is a 10-month, psychosocial intervention for foster parents and girls, with administration of the intervention beginning the summer before entry into middle school. The intervention consists of: (1) six summer Pride groups for the girls, (2) six summer parenting intervention sessions for the foster parents; (3) weekly foster parent training and support sessions for foster parents during the first year of middle school; and (4) weekly individual skills training for the girls during the first year of middle school."
1216977|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216911|NCT00239837|O2|Outcome|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
1216912|NCT00239837|O1|Outcome|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
1216913|NCT00239837|O2|Outcome|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
1216914|NCT00239837|O1|Outcome|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
1216915|NCT00239837|O2|Outcome|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
1216916|NCT00239837|O1|Outcome|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
1216917|NCT00239837|O2|Outcome|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
1216974|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216975|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216978|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216979|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216980|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216981|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216982|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216918|NCT00239837|O1|Outcome|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
1216919|NCT00239837|O2|Outcome|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
1216920|NCT00239837|O1|Outcome|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
1216921|NCT00239837|O2|Outcome|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
1216922|NCT00239837|O1|Outcome|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
1216923|NCT00239837|O2|Outcome|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
1216924|NCT00239837|O1|Outcome|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
1216925|NCT00239837|E2|Reported Event|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
1216926|NCT00239837|E1|Reported Event|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
1216927|NCT00239733|B1|Baseline|Anti-D|"Participants will be given anti-D in an outpatient setting. Participants will be observed for any adverse effects for 1 hour postinfusion. Some participants may require additional doses of anti-D later in the study, depending on individual response to the drug; participants may receive 1 to 6 doses of anti-D.~Anti-D: 30-minute infusion administered in an outpatient setting"
1216928|NCT00239733|P1|Participant Flow|Anti-D|"Participants will be given anti-D in an outpatient setting. Participants will be observed for any adverse effects for 1 hour postinfusion. Some participants may require additional doses of anti-D later in the study, depending on individual response to the drug; participants may receive 1 to 6 doses of anti-D.~Anti-D: 30-minute infusion administered in an outpatient setting"
1216929|NCT00239733|O1|Outcome|Anti-D|"Participants will be given anti-D in an outpatient setting. Participants will be observed for any adverse effects for 1 hour postinfusion. Some participants may require additional doses of anti-D later in the study, depending on individual response to the drug; participants may receive 1 to 6 doses of anti-D.~Anti-D: 30-minute infusion administered in an outpatient setting"
1216930|NCT00239733|O1|Outcome|Anti-D|"Participants will be given anti-D in an outpatient setting. Participants will be observed for any adverse effects for 1 hour postinfusion. Some participants may require additional doses of anti-D later in the study, depending on individual response to the drug; participants may receive 1 to 6 doses of anti-D.~Anti-D: 30-minute infusion administered in an outpatient setting"
1216931|NCT00239733|E1|Reported Event|Anti-D|"Participants will be given anti-D in an outpatient setting. Participants will be observed for any adverse effects for 1 hour postinfusion. Some participants may require additional doses of anti-D later in the study, depending on individual response to the drug; participants may receive 1 to 6 doses of anti-D.~Anti-D: 30-minute infusion administered in an outpatient setting"
1216932|NCT00239720|B3|Baseline|Total|Total of all reporting groups
1216933|NCT00239720|B2|Baseline|Placebo|Intravenous dose of placebo given over 5 days of each 28 day cycle
1216934|NCT00239720|B1|Baseline|hOKT3gamma1 (Ala-Ala)|Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle
1216935|NCT00239720|P2|Participant Flow|Placebo|Intravenous dose of placebo given over 5 days of each 28 day cycle
1216936|NCT00239720|P1|Participant Flow|hOKT3gamma1 (Ala-Ala)|Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle
1216937|NCT00239720|O2|Outcome|Placebo|Intravenous dose of placebo given over 5 days of each 28 day cycle
1216938|NCT00239720|O1|Outcome|hOKT3gamma1 (Ala-Ala)|Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle
1216939|NCT00239720|E2|Reported Event|Placebo|Intravenous dose of placebo given over 5 days of each 28 day cycle
1216940|NCT00239720|E1|Reported Event|hOKT3gamma1 (Ala-Ala)|Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle
1216941|NCT00239681|B3|Baseline|Total|Total of all reporting groups
1216942|NCT00239681|B2|Baseline|Placebo|Placebo once daily
1216943|NCT00239681|B1|Baseline|Rosuvastatin|Rosuvastatin 20 mg once daily
1216944|NCT00239681|P2|Participant Flow|Placebo|Placebo once daily
1216945|NCT00239681|P1|Participant Flow|Rosuvastatin|Rosuvastatin 20 mg once daily
1216946|NCT00239681|O2|Outcome|Placebo|Placebo once daily
1216947|NCT00239681|O1|Outcome|Rosuvastatin|Rosuvastatin 20 mg once daily
1216948|NCT00239681|O2|Outcome|Placebo|Placebo once daily
1216949|NCT00239681|O1|Outcome|Rosuvastatin|Rosuvastatin 20 mg once daily
1216950|NCT00239681|O2|Outcome|Placebo|Placebo once daily
1216951|NCT00239681|O1|Outcome|Rosuvastatin|Rosuvastatin 20 mg once daily
1216952|NCT00239681|O2|Outcome|Placebo|Placebo once daily
1216953|NCT00239681|O1|Outcome|Rosuvastatin|Rosuvastatin 20 mg once daily
1216954|NCT00239681|O2|Outcome|Placebo|Placebo once daily
1216955|NCT00239681|O1|Outcome|Rosuvastatin|Rosuvastatin 20 mg once daily
1216956|NCT00239681|O2|Outcome|Placebo|Placebo once daily
1216957|NCT00239681|O1|Outcome|Rosuvastatin|Rosuvastatin 20 mg once daily
1216958|NCT00239681|E2|Reported Event|ROSUVASTATIN 20 MG|
1216959|NCT00239681|E1|Reported Event|PLACEBO|
1216960|NCT00239642|B4|Baseline|Total|Total of all reporting groups
1216961|NCT00239642|B3|Baseline|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216962|NCT00239642|B2|Baseline|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216963|NCT00239642|B1|Baseline|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216964|NCT00239642|P3|Participant Flow|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216965|NCT00239642|P2|Participant Flow|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216966|NCT00239642|P1|Participant Flow|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216967|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216968|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216969|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216970|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1217295|NCT00237666|E1|Reported Event|Ziprasidone|
1216984|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216985|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216986|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216987|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216988|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216989|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216990|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216991|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216992|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216993|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216994|NCT00239642|E3|Reported Event|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216995|NCT00239642|E2|Reported Event|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216996|NCT00239642|E1|Reported Event|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1216997|NCT00239356|B3|Baseline|Total|Total of all reporting groups
1216998|NCT00239356|B2|Baseline|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
1216999|NCT00239356|B1|Baseline|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
1217000|NCT00239356|P2|Participant Flow|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
1217001|NCT00239356|P1|Participant Flow|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
1217002|NCT00239356|O2|Outcome|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
1217003|NCT00239356|O1|Outcome|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
1217004|NCT00239356|O2|Outcome|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
1217005|NCT00239356|O1|Outcome|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
1217006|NCT00239356|O2|Outcome|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
1217007|NCT00239356|O1|Outcome|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
1217008|NCT00239356|O2|Outcome|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
1217009|NCT00239356|O1|Outcome|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
1217010|NCT00239356|O2|Outcome|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
1217011|NCT00239356|O1|Outcome|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
1217012|NCT00239356|O2|Outcome|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
1217013|NCT00239356|O1|Outcome|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
1217014|NCT00239356|O2|Outcome|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
1217015|NCT00239356|O1|Outcome|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
1217070|NCT00238420|E2|Reported Event|HER2- :RT and Paclitaxel|Paclitaxel chemotherapy concurrent with radiation therapy
1217016|NCT00239356|E2|Reported Event|Schizophrenia 10 - 30 mg QD|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
1217017|NCT00239356|E1|Reported Event|Bipolar I Disorder 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
1217018|NCT00239226|B5|Baseline|Total|Total of all reporting groups
1217019|NCT00239226|B4|Baseline|RAA Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to right atrial appendage (RAA) pacing.
1217020|NCT00239226|B3|Baseline|RAA Pacing Study Group|Patients with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to right atrial appendage (RAA) pacing.
1217021|NCT00239226|B2|Baseline|IAS Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to interatrial septum (IAS) pacing.
1217022|NCT00239226|B1|Baseline|IAS Pacing Study Group|Patients with with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to interatrial septum (IAS) pacing.
1217023|NCT00239226|P4|Participant Flow|RAA Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to right atrial appendage (RAA) pacing.
1217024|NCT00239226|P3|Participant Flow|RAA Pacing Study Group|Patients with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to right atrial appendage (RAA) pacing.
1217025|NCT00239226|P2|Participant Flow|IAS Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to interatrial septum (IAS) pacing.
1217026|NCT00239226|P1|Participant Flow|IAS Pacing Study Group|Patients with with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to interatrial septum (IAS) pacing.
1217027|NCT00239226|O4|Outcome|RAA Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to right atrial appendage (RAA) pacing.
1217028|NCT00239226|O3|Outcome|RAA Pacing Study Group|Patients with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to right atrial appendage (RAA) pacing.
1217029|NCT00239226|O2|Outcome|IAS Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to interatrial septum (IAS) pacing.
1217030|NCT00239226|O1|Outcome|IAS Pacing Study Group|Patients with with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to interatrial septum (IAS) pacing.
1217031|NCT00239226|E4|Reported Event|RAA Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to right atrial appendage (RAA) pacing.
1217032|NCT00239226|E3|Reported Event|RAA Pacing Study Group|Patients with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to right atrial appendage (RAA) pacing.
1217033|NCT00239226|E2|Reported Event|IAS Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to interatrial septum (IAS) pacing.
1217034|NCT00239226|E1|Reported Event|IAS Pacing Study Group|Patients with with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to interatrial septum (IAS) pacing.
1217035|NCT00239005|B3|Baseline|Total|Total of all reporting groups
1217036|NCT00239005|B2|Baseline|Mycophenolate Mofetil (MMF)|250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
1217037|NCT00239005|B1|Baseline|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
1217038|NCT00239005|P2|Participant Flow|Mycophenolate Mofetil (MMF)|250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
1217039|NCT00239005|P1|Participant Flow|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
1217040|NCT00239005|O2|Outcome|Mycophenolate Mofetil (MMF)|250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
1217041|NCT00239005|O1|Outcome|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
1217042|NCT00239005|O2|Outcome|Mycophenolate Mofetil (MMF)|250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
1217043|NCT00239005|O1|Outcome|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
1217044|NCT00239005|O2|Outcome|Mycophenolate Mofetil (MMF)|250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
1217045|NCT00239005|O1|Outcome|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
1217046|NCT00239005|E2|Reported Event|Mycophenolate Mofetil (MMF)|250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
1217047|NCT00239005|E1|Reported Event|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
1217048|NCT00238615|B1|Baseline|Group 1|
1217049|NCT00238615|P1|Participant Flow|Docetaxel / Carboplatin / XRT + Surgical Resection|Patients were treated on this prospective phase II trial of trimodality therapy. Induction treatment consisted of weekly docetaxel 20 mg/m2 and weekly carboplatin at an area under curve (AUC) of 2 concurrent with 45 Gy thoracic radiotherapy. Resection was performed unless felt to be unsafe or if patients had progressive disease. Postoperative consolidation consisted of docetaxel 75 mg/m2 and carboplatin at an AUC of 6 every 3 weeks for 3 cycles with growth factor support. Patients were followed for survival outcomes.
1217071|NCT00238420|E1|Reported Event|HER2+ :RT, Paclitaxel, and Trastuzumab|Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy
1217119|NCT00238238|O2|Outcome|Arm II - Lenalidomide|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12. Treatment repeats every 28 days.
1217050|NCT00238615|O1|Outcome|Docetaxel+Carboplatin +Radiation+Surgery|Patients were treated on this prospective phase II trial of trimodality therapy. Induction treatment consisted of weekly docetaxel 20 mg/m2 and weekly carboplatin at an area under curve (AUC) of 2 concurrent with 45 Gy thoracic radiotherapy. Resection was performed unless felt to be unsafe or if patients had progressive disease. Postoperative consolidation consisted of docetaxel 75 mg/m2 and carboplatin at an AUC of 6 every 3 weeks for 3 cycles with growth factor support. Patients were followed for survival and progression free survival outcomes.These results are published PMID: 21752720.
1217051|NCT00238615|O1|Outcome|Docetaxel / Carboplatin / XRT + Surgical Resection|This planned analysis of gene expression patterns was not performed.
1217257|NCT00237692|P1|Participant Flow|Arm 1- Control|A group of hypertensive patients who receive usual care
1217052|NCT00238615|O1|Outcome|Docetaxel / Carboplatin / XRT + Surgical Resection|"All patients enrolled had combined chemotherapy/radiation followed by surgical resection (other than 1 patient who had only chemotherapy/radiation) and were evaluated for a primary endpoint of 2 year overall survival. PET scans obtained pre and post 5 weeks of combined therapy were analyzed for predictive capacity relative to this endpoint.~Results were published PMID 21774104"
1217053|NCT00238615|E1|Reported Event|Docetaxel / Carboplatin / XRT + Surgical Resection|Adverse events for all enrolled patients were followed. Details are published in PMID: 21752720
1217054|NCT00238433|B1|Baseline|Busulfan/Melphalan/Thiotepa|"Treatment Plan:~Drug: Busulfan 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.~Drug: Melphalan 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.~Drug: Thiotepa 250 mg/m2/day/iv on days -3 and -2.~Procedure/Surgery: Peripheral blood stem cell transplantation. Performed 36-48 hours following last chemotherapy dose.~The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.~Administration Growth Factor: Filgrastim 5mcg/kg IVPB will be administered beginning on day +5 and continued until ANC> 1500 for 2 consecutive days."
1217055|NCT00238433|P1|Participant Flow|Busulfan/Melphalan/Thiotepa|"Treatment:~Drug: Busulfan 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.~Drug: Melphalan 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.~Drug: Thiotepa 250 mg/m2/day/iv on days -3 and -2.~Procedure/Surgery: Peripheral blood stem cell transplantation. Performed 36-48 hours following last chemotherapy dose.~The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.~Administration Growth Factor: Filgrastim 5mcg/kg intravenous piggyback (IVPB) will be administered beginning on day +5 and continued until absolute neutrophil count (ANC) > 1500 for 2 consecutive days."
1217056|NCT00238433|O1|Outcome|Busulfan/Melphalan/Thiotepa|"Treatment Plan:~Drug: Busulfan 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.~Drug: Melphalan 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.~Drug: Thiotepa 250 mg/m2/day/iv on days -3 and -2.~Procedure/Surgery: Peripheral blood stem cell transplantation. Performed 36-48 hours following last chemotherapy dose.~The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.~Administration Growth Factor: Filgrastim 5mcg/kg IVPB will be administered beginning on day +5 and continued until ANC> 1500 for 2 consecutive days."
1217057|NCT00238433|O1|Outcome|Busulfan/Melphalan/Thiotepa|"Busulfan: 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.~Melphalan: 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.~Thiotepa: 250 mg/m2/day/iv on days -3 and -2~Procedure/Surgery: bone marrow ablation with stem cell support~The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.~Procedure/Surgery: Peripheral blood stem cell transplantation. Performed 36-48 hours following last chemotherapy dose.~Growth factor administration: Filgrastim 5mcg/kg IVPB will be administered beginning on day +5 and continued until ANC> 1500 for 2 consecutive days."
1217058|NCT00238433|E1|Reported Event|BuMelTT|"*For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.~TREATMENT PLAN:~Busulfan: 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.~Melphalan: 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.~Thiotepa: 250 mg/m2/day/iv on days -3 and -2~Procedure/Surgery: bone marrow ablation with stem cell support~The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.~Procedure/Surgery: Peripheral blood stem cell transplantation. Performed 36-48 hours following last chemotherapy dose.~Growth factor administration: Filgrastim"
1217059|NCT00238420|B3|Baseline|Total|Total of all reporting groups
1217060|NCT00238420|B2|Baseline|HER2- :RT and Paclitaxel|Paclitaxel chemotherapy concurrent with radiation therapy
1217061|NCT00238420|B1|Baseline|HER2+ :RT, Paclitaxel, and Trastuzumab|Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy
1217062|NCT00238420|P2|Participant Flow|HER2- :RT and Paclitaxel|Paclitaxel chemotherapy concurrent with radiation therapy
1217063|NCT00238420|P1|Participant Flow|HER2+ :RT, Paclitaxel, and Trastuzumab|Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy
1217064|NCT00238420|O2|Outcome|HER2- :RT and Paclitaxel|Paclitaxel chemotherapy concurrent with radiation therapy
1217065|NCT00238420|O1|Outcome|HER2+ :RT, Paclitaxel, and Trastuzumab|Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy
1217066|NCT00238420|O2|Outcome|HER2- :RT and Paclitaxel|Paclitaxel chemotherapy concurrent with radiation therapy
1217067|NCT00238420|O1|Outcome|HER2+ :RT, Paclitaxel, and Trastuzumab|Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy
1217068|NCT00238420|O2|Outcome|HER2- :RT and Paclitaxel|Paclitaxel chemotherapy concurrent with radiation therapy
1217069|NCT00238420|O1|Outcome|HER2+ :RT, Paclitaxel, and Trastuzumab|Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy
1217072|NCT00238355|B1|Baseline|Voriconazole Plus Caspofungin|"Voriconazole: 6mg/kg iv q12 hours x 2 doses OR 400mg po q12hours on day 1 (loading doses). Maintenance doses on day 2 through day 84 may be either 4 mg/kg iv q12 hours, or 200 mg po q12 hours~Caspofungin: 70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84."
1217073|NCT00238355|P1|Participant Flow|Voriconazole Plus Caspofungin|"Voriconazole: 6mg/kg iv q12 hours x 2 doses OR 400mg po q12hours on day 1 (loading doses). Maintenance doses on day 2 through day 84 may be either 4 mg/kg iv q12 hours, or 200 mg po q12 hours~Caspofungin: 70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84."
1217478|NCT00236080|B1|Baseline|PROVIGIL 200 mg/Day|PROVIGIL 200 mg once daily only on nights worked
1217074|NCT00238355|O1|Outcome|Voriconazole Plus Caspofungin|"Voriconazole: 6mg/kg iv q12 hours x 2 doses OR 400mg po q12hours on day 1 (loading doses). Maintenance doses on day 2 through day 84 may be either 4 mg/kg iv q12 hours, or 200 mg po q12 hours~Caspofungin: 70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84."
1217075|NCT00238355|E1|Reported Event|Voriconazole Plus Caspofungin|"Voriconazole: 6mg/kg iv q12 hours x 2 doses OR 400mg po q12hours on day 1 (loading doses). Maintenance doses on day 2 through day 84 may be either 4 mg/kg iv q12 hours, or 200 mg po q12 hours~Caspofungin: 70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84."
1217076|NCT00238303|B4|Baseline|Total|Total of all reporting groups
1217077|NCT00238303|B3|Baseline|Stratum 3 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
1217078|NCT00238303|B2|Baseline|Stratum 2 (Undergoing Surgery)|"Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.~surgery : Patients undergo surgery to remove tumor"
1217079|NCT00238303|B1|Baseline|Stratum 1 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
1217080|NCT00238303|P3|Participant Flow|Stratum 3 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
1217081|NCT00238303|P2|Participant Flow|Stratum 2 (Undergoing Surgery)|"Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.~surgery : Patients undergo surgery to remove tumor"
1217082|NCT00238303|P1|Participant Flow|Stratum 1 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
1217083|NCT00238303|O3|Outcome|Stratum 3 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
1217084|NCT00238303|O2|Outcome|Stratum 2 (Undergoing Surgery)|"Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.~surgery : Patients undergo surgery to remove tumor"
1217085|NCT00238303|O1|Outcome|Stratum 1 Patients That Started Treatment|"Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
1217086|NCT00238303|O3|Outcome|Stratum 3 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
1217087|NCT00238303|O2|Outcome|Stratum 2 (Undergoing Surgery)|"Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.~surgery : Patients undergo surgery to remove tumor"
1217088|NCT00238303|O1|Outcome|Stratum 1 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
1217118|NCT00238238|O3|Outcome|Arm III - Lenalidomide and Rituximab|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12 Patients also receive rituximab 375 mg/m^2 IV on days 8, 15, 22 and 29.
1217089|NCT00238303|O3|Outcome|Stratum 3 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
1217122|NCT00238238|E2|Reported Event|Arm II - Lenalidomide|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12. Treatment repeats every 28 days.
1233028|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1217090|NCT00238303|O2|Outcome|Stratum 2 (Undergoing Surgery)|"Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.~surgery : Patients undergo surgery to remove tumor"
1217091|NCT00238303|O1|Outcome|Stratum 1 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
1217092|NCT00238303|O3|Outcome|Stratum 3 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
1217093|NCT00238303|O2|Outcome|Stratum 2 (Undergoing Surgery)|"Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.~surgery : Patients undergo surgery to remove tumor"
1217094|NCT00238303|O1|Outcome|Stratum 1 Patients That Started Treatment|"Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
1217095|NCT00238303|E3|Reported Event|Stratum 3 (Not Undergoing Surgery)|vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
1217096|NCT00238303|E2|Reported Event|Stratum 2 (Undergoing Surgery)|surgery : Patients undergo surgery to remove tumor
1217097|NCT00238303|E1|Reported Event|Stratum 1 (Not Undergoing Surgery)|vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
1217098|NCT00238264|B1|Baseline|Reduced-field Conformal Radiation Therapy|"Patients undergo reduced-field conformal radiation therapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.~radiation therapy: Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT"
1217099|NCT00238264|P1|Participant Flow|Reduced-field Conformal Radiation Therapy|"Patients undergo reduced-field conformal radiation therapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.~radiation therapy: Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT"
1217100|NCT00238264|O1|Outcome|Reduced-field Conformal Radiation Therapy|Reduced-field conformal radiation therapy 5 days a week for 6 weeks
1217101|NCT00238264|O1|Outcome|Reduced-field Conformal Radiation Therapy|Reduced-field conformal radiation therapy 5 days a week for 6 weeks
1217102|NCT00238264|O1|Outcome|Reduced-field Conformal Radiation Therapy|Reduced-field conformal radiation therapy 5 days a week for 6 weeks
1217103|NCT00238264|O1|Outcome|Reduced-field Conformal Radiation Therapy|Reduced-field conformal radiation therapy 5 days a week for 6 weeks
1217104|NCT00238264|O1|Outcome|Reduced-field Conformal Radiation Therapy|Reduced-field conformal radiation therapy 5 days a week for 6 weeks
1217105|NCT00238264|O1|Outcome|Reduced-field Conformal Radiation Therapy|Reduced-field conformal radiation therapy 5 days a week for 6 weeks
1217106|NCT00238264|O1|Outcome|Reduced-field Conformal Radiation Therapy|Reduced-field conformal radiation therapy 5 days a week for 6 weeks
1217107|NCT00238264|E1|Reported Event|Reduced-field Conformal Radiation Therapy|"Patients undergo reduced-field conformal radiation therapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.~radiation therapy: Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT"
1217108|NCT00238238|B4|Baseline|Total|Total of all reporting groups
1217109|NCT00238238|B3|Baseline|Arm III - Lenalidomide and Rituximab|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12 Patients also receive rituximab 375 mg/m^2 IV on days 8, 15, 22 and 29.
1217110|NCT00238238|B2|Baseline|Arm II - Lenalidomide|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12. Treatment repeats every 28 days.
1217111|NCT00238238|B1|Baseline|Arm I - Rituximab|Patients receive rituximab 375 mg/m^2 IV on days 1, 8, 15, and 22.
1217112|NCT00238238|P3|Participant Flow|Arm III - Lenalidomide and Rituximab|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12 Patients also receive rituximab 375 mg/m^2 IV on days 8, 15, 22 and 29.
1217113|NCT00238238|P2|Participant Flow|Arm II - Lenalidomide|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12. Treatment repeats every 28 days.
1217114|NCT00238238|P1|Participant Flow|Arm I - Rituximab|Patients receive rituximab 375 mg/m^2 IV on days 1, 8, 15, and 22.
1217115|NCT00238238|O3|Outcome|Arm III - Lenalidomide and Rituximab|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12 Patients also receive rituximab 375 mg/m^2 IV on days 8, 15, 22 and 29.
1217116|NCT00238238|O2|Outcome|Arm II - Lenalidomide|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12. Treatment repeats every 28 days.
1217117|NCT00238238|O1|Outcome|Arm I - Rituximab|Patients receive rituximab 375 mg/m^2 IV on days 1, 8, 15, and 22.
1217120|NCT00238238|O1|Outcome|Arm I - Rituximab|Patients receive rituximab 375 mg/m^2 IV on days 1, 8, 15, and 22.
1217121|NCT00238238|E3|Reported Event|Arm III - Lenalidomide and Rituximab|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12 Patients also receive rituximab 375 mg/m^2 IV on days 8, 15, 22 and 29.
1217123|NCT00238238|E1|Reported Event|Arm I - Rituximab|Patients receive rituximab 375 mg/m^2 IV on days 1, 8, 15, and 22.
1217125|NCT00238121|B2|Baseline|Carcinosarcoma|Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1217126|NCT00238121|B1|Baseline|Carcinoma|Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1217127|NCT00238121|P2|Participant Flow|Carcinosarcoma|Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1217128|NCT00238121|P1|Participant Flow|Carcinoma|Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1217129|NCT00238121|O2|Outcome|Carcinosarcoma|Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1217130|NCT00238121|O1|Outcome|Carcinoma|Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1217131|NCT00238121|O2|Outcome|Carcinosarcoma|Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1217132|NCT00238121|O1|Outcome|Carcinoma|Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1217133|NCT00238121|O2|Outcome|Carcinosarcoma|Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1217134|NCT00238121|O1|Outcome|Carcinoma|Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1217135|NCT00238121|O2|Outcome|Carcinosarcoma|Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1217136|NCT00238121|O1|Outcome|Carcinoma|Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1217137|NCT00238121|E1|Reported Event|Sorafenib|
1217138|NCT00238108|B3|Baseline|Total|Total of all reporting groups
1217139|NCT00238108|B2|Baseline|Placebo|Placebo
1217140|NCT00238108|B1|Baseline|Melatonin|Melatonin
1217141|NCT00238108|P2|Participant Flow|Placebo|Placebo
1217142|NCT00238108|P1|Participant Flow|Melatonin|Melatonin
1217143|NCT00238108|O2|Outcome|Placebo|Placebo
1217144|NCT00238108|O1|Outcome|Melatonin|Melatonin
1217145|NCT00238108|E2|Reported Event|Placebo|Placebo
1217146|NCT00238108|E1|Reported Event|Melatonin|Melatonin
1217147|NCT00237809|B5|Baseline|Total|Total of all reporting groups
1217148|NCT00237809|B4|Baseline|Placebo/Control|"Placebo/control~Cognitive retraining : Cog rehab"
1217149|NCT00237809|B3|Baseline|D-serine/Cog Rehab|"D-serine/cog rehab~D-serine : D-serine (30 mg/kg)"
1217150|NCT00237809|B2|Baseline|Placebo/Cog Rehab|"Placebo/cog rehab~Cognitive retraining : Cog rehab"
1217151|NCT00237809|B1|Baseline|D-serine/Control|"D-serine/control~D-serine : D-serine (30 mg/kg)"
1217152|NCT00237809|P4|Participant Flow|Placebo Drug/ Placebo CRT|Placebo/control
1217153|NCT00237809|P3|Participant Flow|D-serine Drug/CRT|"D-serine/cog rehab~D-serine : D-serine (30 mg/kg)"
1217154|NCT00237809|P2|Participant Flow|Placebo Drug /CRT|"Placebo/cog rehab~Cognitive retraining : Cog rehab"
1217155|NCT00237809|P1|Participant Flow|D-serine Drug /CRT Placebo|"D-serine/control~D-serine : D-serine (30 mg/kg)"
1217156|NCT00237809|O4|Outcome|Placebo/Control|"Placebo/control~Cognitive retraining : video"
1217157|NCT00237809|O3|Outcome|D-serine/Cog Rehab|"D-serine/cog rehab~D-serine : D-serine (30 mg/kg)"
1217158|NCT00237809|O2|Outcome|Placebo/Cog Rehab|"Placebo/cog rehab~Cognitive retraining : Cog rehab"
1217159|NCT00237809|O1|Outcome|D-serine/Control|"D-serine/control~D-serine : D-serine (30 mg/kg)"
1217160|NCT00237809|O4|Outcome|Placebo/Control|"Placebo/control~Cognitive retraining : video"
1217161|NCT00237809|O3|Outcome|D-serine/Cog Rehab|"D-serine/cog rehab~D-serine : D-serine (30 mg/kg)"
1217162|NCT00237809|O2|Outcome|Placebo/Cog Rehab|"Placebo/cog rehab~Cognitive retraining : Cog rehab"
1217163|NCT00237809|O1|Outcome|D-serine/Control|"D-serine/control~D-serine : D-serine (30 mg/kg)"
1217164|NCT00237809|O4|Outcome|Placebo/Control|"Placebo/control~Cognitive retraining : video"
1217165|NCT00237809|O3|Outcome|D-serine/Cog Rehab|"D-serine/cog rehab~D-serine : D-serine (30 mg/kg)"
1217166|NCT00237809|O2|Outcome|Placebo/Cog Rehab|"Placebo/cog rehab~Cognitive retraining : Cog rehab"
1217167|NCT00237809|O1|Outcome|D-serine/Control|"D-serine/control~D-serine : D-serine (30 mg/kg)"
1217168|NCT00237809|O4|Outcome|Placebo/Control|"Placebo/control~Cognitive retraining : video"
1217169|NCT00237809|O3|Outcome|D-serine/Cog Rehab|"D-serine/cog rehab~D-serine : D-serine (30 mg/kg)"
1217170|NCT00237809|O2|Outcome|Placebo/Cog Rehab|"Placebo/cog rehab~Cognitive retraining : Cog rehab"
1217171|NCT00237809|O1|Outcome|D-serine/Control|"D-serine/control~D-serine : D-serine (30 mg/kg)"
1217172|NCT00237809|O4|Outcome|Placebo/Control|"Placebo/control~Cognitive retraining : video"
1218918|NCT00227903|O1|Outcome|Brief Advice|Advice and education
1217179|NCT00237809|O1|Outcome|D-serine/Control|"D-serine/control~D-serine : D-serine (30 mg/kg)"
1217180|NCT00237809|O4|Outcome|Placebo/Control|"Placebo/control~Cognitive retraining : video"
1217181|NCT00237809|O3|Outcome|D-serine/Cog Rehab|"D-serine/cog rehab~D-serine : D-serine (30 mg/kg)"
1217182|NCT00237809|O2|Outcome|Placebo/Cog Rehab|"Placebo/cog rehab~Cognitive retraining : Cog rehab"
1217183|NCT00237809|O1|Outcome|D-serine/Control|"D-serine/control~D-serine : D-serine (30 mg/kg)"
1217184|NCT00237809|E4|Reported Event|Placebo/Control|"Placebo/control~Cognitive retraining : video"
1217189|NCT00237796|B2|Baseline|Goal Focused Supportive Contact (GFSC)|Goal Directed Supportive Care Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
1217190|NCT00237796|B1|Baseline|Cognitive Behavioral Social Skills Training (CBSST)|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
1217191|NCT00237796|P2|Participant Flow|Goal Focused Supportive Contact (GFSC)|Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
1217192|NCT00237796|P1|Participant Flow|Cognitive Behavioral Social Skills Training (CBSST)|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
1217193|NCT00237796|O2|Outcome|Goal Focused Supportive Contact|Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
1217194|NCT00237796|O1|Outcome|Cognitive Behavioral Social Skills Training|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
1217195|NCT00237796|O2|Outcome|Goal Focused Supportive Contact|Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
1217196|NCT00237796|O1|Outcome|Cognitive Behavioral Social Skills Training|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
1217197|NCT00237796|O2|Outcome|Goal Focused Supportive Contact|Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
1217198|NCT00237796|O1|Outcome|Cognitive Behavioral Social Skills Training|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
1217199|NCT00237796|O2|Outcome|Goal Focused Supportive Contact|Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
1217200|NCT00237796|O1|Outcome|Cognitive Behavioral Social Skills Training|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
1217201|NCT00237796|O2|Outcome|Goal Focused Supportive Contact|Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
1217202|NCT00237796|O1|Outcome|Cognitive Behavioral Social Skills Training|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
1217203|NCT00237796|O2|Outcome|Goal Focused Supportive Contact|Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
1217204|NCT00237796|O1|Outcome|Cognitive Behavioral Social Skills Training|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
1217205|NCT00237796|O2|Outcome|Goal Focused Supportive Contact|"Goal Focused Supportive Contact~Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months."
1217206|NCT00237796|O1|Outcome|Cognitive Behavioral Social Skills Training|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
1217207|NCT00237796|E2|Reported Event|Goal Directed Supportive Care|Goal Directed Supportive Care Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
1217208|NCT00237796|E1|Reported Event|CBSST|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
1217209|NCT00237770|B3|Baseline|Total|Total of all reporting groups
1217210|NCT00237770|B2|Baseline|Able-bodied Controls|Systolic blood pressure responses to head-up tilt were determined in able-bodied controls following placebo administration
1217211|NCT00237770|B1|Baseline|Individuals With Tetraplegia|Systolic blood pressure responses to head-up tilt were determined after placebo, L-NAME (1.0 mg/kg) and L-NAME administration (2.0 mg/kg) administration.
1217212|NCT00237770|P2|Participant Flow|Control Subjects|Systolic blood pressure responses to head-up tilt were determined in non-spinal cord injured control subjects following placebo administration. Control subjects visited the laboratory for 1 visit.
1217213|NCT00237770|P1|Participant Flow|Tetraplegic Subjects|All tetraplegic subjects underwent a head-up tilt maneuver to determine systolic blood pressure responses to placebo L-NAME 1.0 mg/kg and L-NAME 2.0 mg/kg. Subjects with tetraplegia visited the laboratory on 3 separate occasions.
1217214|NCT00237770|O4|Outcome|Tetraplegic Systolic Blood Pressure Responses to L-NAME 2.0 mg|Systolic blood pressure responses during head-up tilt were determined following L-NAME administration (2.0 mg/kg)
1217215|NCT00237770|O3|Outcome|Tetraplegic Systolic Blood Pressure Responses to L-NAME 1.0 mg|Systolic blood pressure responses to head-up tilt were determined following administration of L-NAME (1.0 mg/kg)
1217475|NCT00236080|B4|Baseline|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily only on nights worked
1217216|NCT00237770|O2|Outcome|Control Systolic Blood Pressure Responses to Placebo|Systolic blood pressure responses to head-up tilt were determined in non spinal cord injured controls following placebo administration
1217217|NCT00237770|O1|Outcome|Tetraplegic Systolic Blood Pressure Responses to Placebo|Systolic blood pressure responses to head-up tilt were determined after placebo administration in persons with tetraplegia
1217218|NCT00237770|E4|Reported Event|Tetraplegic Systolic Blood Pressure Responses to L-NAME 2.0 mg|Systolic blood pressure responses during head-up tilt were determined following L-NAME administration (2.0 mg/kg)
1217219|NCT00237770|E3|Reported Event|Tetraplegic Systolic Blood Pressure Responses to L-NAME 1.0 mg|Systolic blood pressure responses to head-up tilt were determined following administration of L-NAME (1.0 mg/kg)
1217220|NCT00237770|E2|Reported Event|Control Systolic Blood Pressure Responses to Placebo|Systolic blood pressure responses to head-up tilt were determined in non spinal cord injured controls following placebo administration
1217221|NCT00237770|E1|Reported Event|Tetraplegic Systolic Blood Pressure Responses to Placebo|Systolic blood pressure responses to head-up tilt were determined after placebo administration in persons with tetraplegia
1217222|NCT00237744|B4|Baseline|Total|Total of all reporting groups
1217223|NCT00237744|B3|Baseline|Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of shoulder/elbow=wrist hand
1217224|NCT00237744|B2|Baseline|Wrist/Hand FES + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of wrist hand >shoulder/elbow
1217225|NCT00237744|B1|Baseline|Shoulder/Elbow Robotics + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of shoulder/elbow > wrist hand.
1217226|NCT00237744|P3|Participant Flow|Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning.
1217227|NCT00237744|P2|Participant Flow|Shoulder/Elbow Robotics + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and shoulder/elbow robotics.
1217228|NCT00237744|P1|Participant Flow|Wrist/Hand FES + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and wrist/hand FES.
1217229|NCT00237744|O3|Outcome|Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning.
1217230|NCT00237744|O2|Outcome|Shoulder/Elbow Robotics + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and shoulder/elbow robotics.
1217231|NCT00237744|O1|Outcome|Wrist/Hand FES + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and wrist/hand FES.
1217232|NCT00237744|O3|Outcome|Whole Arm Motor Learning Group|Interventions included whole arm motor learning, FES and Robotics.
1217233|NCT00237744|O2|Outcome|Wrist/Hand FES+Whole Arm Motor Learning|The intervention provided in this group included surface FES and whole are motor learning.
1217234|NCT00237744|O1|Outcome|Shoulder/Elbow Robotics+Whole Arm Motor Learning|Subjects>6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and shoulder/elbow robotics.
1217235|NCT00237744|E3|Reported Event|Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of shoulder/elbow = wrist hand.
1217236|NCT00237744|E2|Reported Event|Shoulder/Elbow Robotics + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of shoulder/elbow > wrist hand.
1217237|NCT00237744|E1|Reported Event|Wrist/Hand FES + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of wrist/hand> shoulder/elbow.)
1217238|NCT00237718|B3|Baseline|Total|Total of all reporting groups
1217239|NCT00237718|B2|Baseline|Placebo|placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
1217240|NCT00237718|B1|Baseline|ALA and Vitamin E|600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
1217241|NCT00237718|P2|Participant Flow|Placebo|placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
1217242|NCT00237718|P1|Participant Flow|ALA and Vitamin E|600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
1217243|NCT00237718|O2|Outcome|Placebo|placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
1217244|NCT00237718|O1|Outcome|ALA and Vitamin E|600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
1217245|NCT00237718|O2|Outcome|Placebo|placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
1217246|NCT00237718|O1|Outcome|ALA and Vitamin E|600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
1217247|NCT00237718|E2|Reported Event|Placebo|placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
1217248|NCT00237718|E1|Reported Event|ALA and Vitamin E|600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
1217249|NCT00237692|B5|Baseline|Total|Total of all reporting groups
1217250|NCT00237692|B4|Baseline|Arm 4 - Combined Behavioral and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
1217476|NCT00236080|B3|Baseline|Armodafinil 200 mg/Day|Armodafinil 200 mg once daily only on nights worked
1217251|NCT00237692|B3|Baseline|Arm 3 - Nurse Med Managment Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
1217252|NCT00237692|B2|Baseline|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
1217253|NCT00237692|B1|Baseline|Arm 1- Control|A group of hypertensive patients who receive usual care
1217254|NCT00237692|P4|Participant Flow|Arm 4 - Combined Behavioral and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
1217255|NCT00237692|P3|Participant Flow|Arm 3 - Nurse Med Managment Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
1217256|NCT00237692|P2|Participant Flow|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
1217258|NCT00237692|O4|Outcome|Arm 4 - Combined Behaviorial and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
1217259|NCT00237692|O3|Outcome|Arm 3 - Nurse Med Management Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
1217260|NCT00237692|O2|Outcome|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
1217261|NCT00237692|O1|Outcome|Arm 1- Control|a group of hypertensive patients who receive usual care
1217262|NCT00237692|O4|Outcome|Arm 4 - Combined Behaviorial and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
1217263|NCT00237692|O3|Outcome|Arm 3 - Nurse Med Management Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
1217264|NCT00237692|O2|Outcome|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
1217265|NCT00237692|O1|Outcome|Arm 1- Control|a group of hypertensive patients who receive usual care
1217266|NCT00237692|O4|Outcome|Arm 4 - Combined Behaviorial and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
1217267|NCT00237692|O3|Outcome|Arm 3 - Nurse Med Management Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
1217268|NCT00237692|O2|Outcome|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
1217269|NCT00237692|O1|Outcome|Arm 1- Control|a group of hypertensive patients who receive usual care
1217270|NCT00237692|O4|Outcome|Arm 4 - Combined Behaviorial and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
1217271|NCT00237692|O3|Outcome|Arm 3 - Nurse Med Management Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
1217272|NCT00237692|O2|Outcome|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
1217273|NCT00237692|O1|Outcome|Arm 1- Control|a group of hypertensive patients who receive usual care
1217274|NCT00237692|O4|Outcome|Arm 4 - Combined Behaviorial and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
1217275|NCT00237692|O3|Outcome|Arm 3 - Nurse Med Management Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
1217276|NCT00237692|O2|Outcome|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
1217277|NCT00237692|O1|Outcome|Arm 1- Control|a group of hypertensive patients who receive usual care
1217278|NCT00237692|O4|Outcome|Arm 4 - Combined Behaviorial and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
1217279|NCT00237692|O3|Outcome|Arm 3 - Nurse Med Management Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
1217280|NCT00237692|O2|Outcome|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
1217281|NCT00237692|O1|Outcome|Arm 1- Control|a group of hypertensive patients who receive usual care
1217282|NCT00237692|E4|Reported Event|Arm 4 - Combined Behavioral and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
1217283|NCT00237692|E3|Reported Event|Arm 3 - Nurse Med Managment Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
1217284|NCT00237692|E2|Reported Event|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
1217285|NCT00237692|E1|Reported Event|Arm 1- Control|A group of hypertensive patients who receive usual care
1217286|NCT00237666|B1|Baseline|Ziprasidone|
1217287|NCT00237666|P1|Participant Flow|Ziprasidone|Patients will receive 8 weeks of active treatment with ziprasidone, initiated at 20mg BID. Depending on tolerability and clinical response, the dosage can be titrated up to a maximum of 60mg BID per day. Dosage can be lowered or temporarily stopped if necessary because of adverse events.
1217288|NCT00237666|O1|Outcome|Ziprasidone|Ziprasidone 20-60 mg BID
1217289|NCT00237666|O1|Outcome|Ziprasidone|Ziprasidone 20-60 mg BID
1217290|NCT00237666|O1|Outcome|Ziprasidone|Ziprasidone 20-60 mg BID
1217291|NCT00237666|O1|Outcome|Ziprasidone|Ziprasidone 20-60 mg BID
1217292|NCT00237666|O1|Outcome|Ziprasidone|Ziprasidone 20-60 mg BID
1217293|NCT00237666|O1|Outcome|Ziprasidone|Ziprasidone 20-60 mg BID
1217294|NCT00237666|O1|Outcome|Ziprasidone|Ziprasidone 20-60 mg BID
1217296|NCT00237458|B1|Baseline|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
1217297|NCT00237458|P1|Participant Flow|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
1217298|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
1217299|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
1217300|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
1217301|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
1217479|NCT00236080|P5|Participant Flow|Placebo|Matching placebo tablets once daily only on nights worked
1217302|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
1217303|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
1217304|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
1217305|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
1217306|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
1217307|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
1217308|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
1217309|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
1217310|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
1217311|NCT00237458|E1|Reported Event|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
1217312|NCT00237185|B3|Baseline|Total|Total of all reporting groups
1217313|NCT00237185|B2|Baseline|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
1217314|NCT00237185|B1|Baseline|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
1217315|NCT00237185|P2|Participant Flow|Imatinib Mesylate 600 mg|imatinib mesylate 600 mg once daily
1217316|NCT00237185|P1|Participant Flow|Imatinib Mesylate 400 mg|imatinib mesylate 400 mg once daily
1217317|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
1217318|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
1217319|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
1217320|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
1217321|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
1217322|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
1217323|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
1217324|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
1217325|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
1217326|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
1217327|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
1217328|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
1217329|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
1217330|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
1217331|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
1217332|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
1217333|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
1217334|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
1217335|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
1217336|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
1217337|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
1217338|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
1217339|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
1217340|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
1217341|NCT00237185|E2|Reported Event|Imatinib Mesylate 600 mg|600 mg
1217342|NCT00237185|E1|Reported Event|Imatinib Mesylate 400 mg|400 mg
1217343|NCT00237042|B4|Baseline|Total|Total of all reporting groups
1217344|NCT00237042|B3|Baseline|Continuous Oral Contraceptives|20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
1217345|NCT00237042|B2|Baseline|Targeted Self Management|Self management as described for the first arm. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
1217360|NCT00237042|O2|Outcome|Targeted Self Management|Self management as described for the first arm. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
1217477|NCT00236080|B2|Baseline|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily only on nights worked
1217346|NCT00237042|B1|Baseline|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
1217347|NCT00237042|P3|Participant Flow|Continuous Oral Contraceptives|20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
1217348|NCT00237042|P2|Participant Flow|Targeted Self Management|Self management as described for the first arm. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
1217349|NCT00237042|P1|Participant Flow|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
1217350|NCT00237042|O3|Outcome|Continuous Oral Contraceptives|20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
1217351|NCT00237042|O2|Outcome|Targeted Self Management|Self management as described for the first arm. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
1217352|NCT00237042|O1|Outcome|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
1217353|NCT00237042|O3|Outcome|Continuous Oral Contraceptives|20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
1217354|NCT00237042|O2|Outcome|Targeted Self Management|Self management as described for the first arm. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
1217355|NCT00237042|O1|Outcome|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
1217356|NCT00237042|O3|Outcome|Continuous Oral Contraceptives|20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
1217357|NCT00237042|O2|Outcome|Targeted Self Management|Self management as described for the first arm. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
1217358|NCT00237042|O1|Outcome|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
1217359|NCT00237042|O3|Outcome|Continuous Oral Contraceptives|20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
1217455|NCT00236197|B3|Baseline|Total|Total of all reporting groups
1217456|NCT00236197|B2|Baseline|Rabeprazole 10 mg|
1217457|NCT00236197|B1|Baseline|Placebo|
1217361|NCT00237042|O1|Outcome|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
1217362|NCT00237042|E3|Reported Event|Continuous Oral Contraceptives|20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
1217363|NCT00237042|E2|Reported Event|Targeted Self Management|Self management as described for the first arm. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
1217364|NCT00237042|E1|Reported Event|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
1217365|NCT00236977|B3|Baseline|Total|Total of all reporting groups
1217366|NCT00236977|B2|Baseline|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
1217367|NCT00236977|B1|Baseline|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
1217368|NCT00236977|P2|Participant Flow|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
1217369|NCT00236977|P1|Participant Flow|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
1217370|NCT00236977|O2|Outcome|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
1217371|NCT00236977|O1|Outcome|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
1217372|NCT00236977|O2|Outcome|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
1217373|NCT00236977|O1|Outcome|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
1217374|NCT00236977|O2|Outcome|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
1217375|NCT00236977|O1|Outcome|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
1217376|NCT00236977|O2|Outcome|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
1217377|NCT00236977|O1|Outcome|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
1217378|NCT00236977|O2|Outcome|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
1217379|NCT00236977|O1|Outcome|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
1217380|NCT00236977|O2|Outcome|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
1217381|NCT00236977|O1|Outcome|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
1217382|NCT00236977|O2|Outcome|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
1217383|NCT00236977|O1|Outcome|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
1217384|NCT00236977|E2|Reported Event|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
1217385|NCT00236977|E1|Reported Event|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
1217386|NCT00236951|B5|Baseline|Total|Total of all reporting groups
1217387|NCT00236951|B4|Baseline|Group D: Erythropoietin Only (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin only.
1217388|NCT00236951|B3|Baseline|Group C: Erythropoietin + Venofer (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
1217389|NCT00236951|B2|Baseline|Group B: Erythropoietin Only (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin only.
1217458|NCT00236197|P2|Participant Flow|Rabeprazole 10 mg|
1217390|NCT00236951|B1|Baseline|Group A: Erythropoietin + Venofer (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
1217391|NCT00236951|P4|Participant Flow|Group D: Erythropoietin Only (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin only.
1217392|NCT00236951|P3|Participant Flow|Group C: Erythropoietin + Venofer (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
1234736|NCT00138645|O2|Outcome|Healthy Diet|Healthy Diet
1217393|NCT00236951|P2|Participant Flow|Group B: Erythropoietin Only (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin only.
1217394|NCT00236951|P1|Participant Flow|Group A: Erythropoietin + Venofer (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
1217395|NCT00236951|O4|Outcome|Group D: Erythropoietin Only (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin only.
1217396|NCT00236951|O3|Outcome|Group C: Erythropoietin + Venofer (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
1217397|NCT00236951|O2|Outcome|Group B: Erythropoietin Only (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin only.
1217398|NCT00236951|O1|Outcome|Group A: Erythropoietin + Venofer (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
1217399|NCT00236951|E4|Reported Event|Group D: Erythropoietin Only (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin only.
1217400|NCT00236951|E3|Reported Event|Group C: Erythropoietin + Venofer (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
1217401|NCT00236951|E2|Reported Event|Group B: Erythropoietin Only (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin only.
1217402|NCT00236951|E1|Reported Event|Group A: Erythropoietin + Venofer (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
1217403|NCT00236938|B3|Baseline|Total|Total of all reporting groups
1217404|NCT00236938|B2|Baseline|Group B: Erythropoietin EPO Fixed Dose Only|Stable erythropoietin (EPO) dose and no supplemental iron.
1217405|NCT00236938|B1|Baseline|Group A: Venofer and Erythropoietin EPO Fixed Dose|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
1217406|NCT00236938|P2|Participant Flow|Group B: Erythropoietin EPO Fixed Dose Only|Stable erythropoietin (EPO) dose and no supplemental iron.
1217407|NCT00236938|P1|Participant Flow|Group A: Venofer and Erythropoietin EPO Fixed Dose|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
1217408|NCT00236938|O2|Outcome|Group B: Erythropoietin EPO Fixed Dose Only|Stable erythropoietin (EPO) dose and no supplemental iron.
1217409|NCT00236938|O1|Outcome|Group A: Venofer and Erythropoietin EPO Fixed Dose|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
1217410|NCT00236938|O2|Outcome|Group B: Erythropoietin EPO Fixed Dose Only|Stable erythropoietin (EPO) dose and no supplemental iron.
1217411|NCT00236938|O1|Outcome|Group A: Venofer and Erythropoietin EPO Fixed Dose|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
1217412|NCT00236938|O2|Outcome|Group B: Erythropoietin EPO Fixed Dose Only|Stable erythropoietin (EPO) dose and no supplemental iron.
1217413|NCT00236938|O1|Outcome|Group A: Venofer and Erythropoietin EPO Fixed Dose|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
1217414|NCT00236938|O2|Outcome|Group B: Erythropoietin EPO Fixed Dose Only|Stable erythropoietin (EPO) dose and no supplemental iron.
1217415|NCT00236938|O1|Outcome|Group A: Venofer and Erythropoietin EPO Fixed Dose|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
1217416|NCT00236938|E2|Reported Event|Group B: Erythropoietin EPO Fixed Dose Only|Stable erythropoietin (EPO) dose and no supplemental iron.
1217459|NCT00236197|P1|Participant Flow|Placebo|
1217460|NCT00236197|O2|Outcome|Rabeprazole 10 mg|
1217461|NCT00236197|O1|Outcome|Placebo|
1217462|NCT00236197|E2|Reported Event|Rabeprazole 10 mg|
1217417|NCT00236938|E1|Reported Event|Group A: Venofer and Erythropoietin EPO Fixed Dose|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
1217418|NCT00236899|B5|Baseline|Total|Total of all reporting groups
1217419|NCT00236899|B4|Baseline|Arm D: Paclitaxel and Gemcitabine (Weekly)|"Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
1217480|NCT00236080|P4|Participant Flow|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily only on nights worked
1217481|NCT00236080|P3|Participant Flow|Armodafinil 200 mg/Day|Armodafinil 200 mg once daily only on nights worked
1217420|NCT00236899|B3|Baseline|Arm C: Docetaxel and Gemcitabine (Weekly)|"Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
1217421|NCT00236899|B2|Baseline|Arm B: Paclitaxel and Gemcitabine (Tri-weekly)|"Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
1217422|NCT00236899|B1|Baseline|Arm A: Docetaxel and Gemcitabine (Tri-weekly)|"Docetaxel: 75 milligram per square meter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).~Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
1217423|NCT00236899|P4|Participant Flow|Arm D: Paclitaxel and Gemcitabine (Weekly)|"Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
1217424|NCT00236899|P3|Participant Flow|Arm C: Docetaxel and Gemcitabine (Weekly)|"Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
1217425|NCT00236899|P2|Participant Flow|Arm B: Paclitaxel and Gemcitabine (Tri-weekly)|"Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
1217426|NCT00236899|P1|Participant Flow|Arm A: Docetaxel and Gemcitabine (Tri-weekly)|"Docetaxel: 75 milligram per square meter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).~Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
1217427|NCT00236899|O4|Outcome|Arm D: Paclitaxel and Gemcitabine (Weekly)|"Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
1217428|NCT00236899|O3|Outcome|Arm C: Docetaxel and Gemcitabine (Weekly)|"Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
1217429|NCT00236899|O2|Outcome|Arm B: Paclitaxel and Gemcitabine (Tri-weekly)|"Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
1217430|NCT00236899|O1|Outcome|Arm A: Docetaxel and Gemcitabine (Tri-weekly)|"Docetaxel: 75 milligram per square meter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).~Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
1217431|NCT00236899|O4|Outcome|Arm D: Paclitaxel and Gemcitabine (Weekly)|"Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
1217432|NCT00236899|O3|Outcome|Arm C: Docetaxel and Gemcitabine (Weekly)|"Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
1217463|NCT00236197|E1|Reported Event|Placebo|
1217464|NCT00236184|B3|Baseline|Total|Total of all reporting groups
1217465|NCT00236184|B2|Baseline|Rabeprazole 10 mg|oral enteric-coated tablet
1217466|NCT00236184|B1|Baseline|Placebo|oral placebo tablet
1217433|NCT00236899|O2|Outcome|Arm B: Paclitaxel and Gemcitabine (Tri-weekly)|"Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
1217482|NCT00236080|P2|Participant Flow|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily only on nights worked
1217483|NCT00236080|P1|Participant Flow|PROVIGIL 200 mg/Day|PROVIGIL 200 mg once daily only on nights worked
1217484|NCT00236080|O5|Outcome|Placebo|Matching placebo tablets once daily only on nights worked
1217434|NCT00236899|O1|Outcome|Arm A: Docetaxel and Gemcitabine (Tri-weekly)|"Docetaxel: 75 milligram per square meter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).~Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
1217435|NCT00236899|O4|Outcome|Arm D: Paclitaxel and Gemcitabine (Weekly)|"Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
1217436|NCT00236899|O3|Outcome|Arm C: Docetaxel and Gemcitabine (Weekly)|"Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
1217437|NCT00236899|O2|Outcome|Arm B: Paclitaxel and Gemcitabine (Tri-weekly)|"Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
1217438|NCT00236899|O1|Outcome|Arm A: Docetaxel and Gemcitabine (Tri-weekly)|"Docetaxel: 75 milligram per square millimeter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs=≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).~Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
1217439|NCT00236899|O2|Outcome|Treatment Drug (Paclitaxel)|"Arm B, Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm D, Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15 followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until disease progression."
1217440|NCT00236899|O1|Outcome|Treatment Drug (Docetaxel)|"Arm A, Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1000 mg/m² 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm C, Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 min prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15, repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
1217441|NCT00236899|O2|Outcome|Treatment Drug (Paclitaxel)|"Arm B, Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm D, Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15 followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until disease progression."
1217442|NCT00236899|O1|Outcome|Treatment Drug (Docetaxel)|"Arm A, Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1000 mg/m² 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm C, Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 min prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15, repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
1217443|NCT00236899|O2|Outcome|Treatment Schedule (3 Weekly)|"Arm A, Docetaxel and Gemcitabine (3 Weekly):~Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm B, Paclitaxel and Gemcitabine (3 Weekly):~Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
1217467|NCT00236184|P2|Participant Flow|Rabeprazole 10 mg|
1217468|NCT00236184|P1|Participant Flow|Placebo|
1217469|NCT00236184|O2|Outcome|Rabeprazole 10 mg|
1217470|NCT00236184|O1|Outcome|Placebo|
1217471|NCT00236184|E2|Reported Event|Rabeprazole 10 mg|
1217472|NCT00236184|E1|Reported Event|Placebo|
1217473|NCT00236080|B6|Baseline|Total|Total of all reporting groups
1217474|NCT00236080|B5|Baseline|Placebo|Matching placebo tablets once daily only on nights worked
1217485|NCT00236080|O4|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily only on nights worked
1217486|NCT00236080|O3|Outcome|Armodafinil 200 mg/Day|Armodafinil 200 mg once daily only on nights worked
1217487|NCT00236080|O2|Outcome|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily only on nights worked
1217444|NCT00236899|O1|Outcome|Treatment Schedule (Weekly)|"Arm C, Docetaxel and Gemcitabine (Weekly):~Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm D, Paclitaxel and Gemcitabine (Weekly):~Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
1217445|NCT00236899|O2|Outcome|Treatment Drug (Paclitaxel)|"Arm B, Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm D, Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15 followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until disease progression."
1217446|NCT00236899|O1|Outcome|Treatment Drug (Docetaxel)|"Arm A, Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1000 mg/m² 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm C, Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 min prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15, repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
1217447|NCT00236899|O2|Outcome|Treatment Schedule (3 Weekly)|"Arm A, Docetaxel and Gemcitabine (3 Weekly):~Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm B, Paclitaxel and Gemcitabine (3 Weekly):~Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
1217448|NCT00236899|O1|Outcome|Treatment Schedule (Weekly)|"Arm C, Docetaxel and Gemcitabine (Weekly):~Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm D, Paclitaxel and Gemcitabine (Weekly):~Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
1217449|NCT00236899|O2|Outcome|Treatment Schedule (3 Weekly)|"Arm A, Docetaxel and Gemcitabine (3 Weekly):~Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm B, Paclitaxel and Gemcitabine (3 Weekly):~Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
1217450|NCT00236899|O1|Outcome|Treatment Schedule (Weekly)|"Arm C, Docetaxel and Gemcitabine (Weekly):~Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm D, Paclitaxel and Gemcitabine (Weekly):~Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
1217451|NCT00236899|E4|Reported Event|Arm D: Paclitaxel and Gemcitabine (Weekly)|"Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
1217452|NCT00236899|E3|Reported Event|Arm C: Docetaxel and Gemcitabine (Weekly)|"Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
1217453|NCT00236899|E2|Reported Event|Arm B: Paclitaxel and Gemcitabine (Tri-weekly)|"Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
1217454|NCT00236899|E1|Reported Event|Arm A: Docetaxel and Gemcitabine (Tri-weekly)|"Docetaxel: 75 milligram per square millimeter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs=≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).~Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
1217490|NCT00236080|O4|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily only on nights worked
1217491|NCT00236080|O3|Outcome|Armodafinil 200 mg/Day|Armodafinil 200 mg once daily only on nights worked
1217492|NCT00236080|O2|Outcome|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily only on nights worked
1217493|NCT00236080|O1|Outcome|PROVIGIL 200 mg/Day|PROVIGIL 200 mg once daily only on nights worked
1217494|NCT00236080|E5|Reported Event|Placebo|Matching placebo tablets once daily only on nights worked
1217495|NCT00236080|E4|Reported Event|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily only on nights worked
1217496|NCT00236080|E3|Reported Event|Armodafinil 200 mg/Day|Armodafinil 200 mg once daily only on nights worked
1217497|NCT00236080|E2|Reported Event|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily only on nights worked
1217498|NCT00236080|E1|Reported Event|PROVIGIL 200 mg/Day|PROVIGIL 200 mg once daily only on nights worked
1217499|NCT00235989|B5|Baseline|Total|Total of all reporting groups
1217500|NCT00235989|B4|Baseline|ET: IFNB-1b 250 mcg => 500 mcg|Extension Treatment 250 mcg increased to 500 mcg
1217501|NCT00235989|B3|Baseline|ET: IFNB-1b 500 mcg => 500 mcg|Extension Treatment 500 mcg continued
1217502|NCT00235989|B2|Baseline|ET: IFNB-1b 500 mcg => 250 mcg|Extension Treatment 500 mcg reduced to 250 mcg
1217503|NCT00235989|B1|Baseline|ET: IFNB-1b 250 mcg => 250 mcg|Extension Treatment 250 mcg continued
1217504|NCT00235989|P6|Participant Flow|CT: IFNB-1b 500mcg|Core Treatment 500 mcg
1217505|NCT00235989|P5|Participant Flow|CT: IFNB-1b 250mcg|Core Treatment 250 mcg
1217506|NCT00235989|P4|Participant Flow|ET: IFNB-1b 250 mcg => 500 mcg|Extension Treatment 250 mcg increased to 500 mcg
1217507|NCT00235989|P3|Participant Flow|ET: IFNB-1b 500 mcg => 500 mcg|Extension Treatment 500 mcg continued
1217508|NCT00235989|P2|Participant Flow|ET: IFNB-1b 500 mcg => 250 mcg|Extension Treatment 500 mcg reduced to 250 mcg
1217509|NCT00235989|P1|Participant Flow|ET: IFNB-1b 250 mcg => 250 mcg|Extension Treatment 250 mcg continued
1217510|NCT00235989|O4|Outcome|ET: IFNB-1b 250 mcg => 500 mcg|Extension Treatment 250 mcg increased to 500 mcg
1217511|NCT00235989|O3|Outcome|ET: IFNB-1b 500 mcg => 500 mcg|Extension Treatment 500 mcg continued
1217512|NCT00235989|O2|Outcome|ET: IFNB-1b 500 mcg => 250 mcg|Extension Treatment 500 mcg reduced to 250 mcg
1217513|NCT00235989|O1|Outcome|ET: IFNB-1b 250 mcg => 250 mcg|Extension Treatment 250 mcg continued
1217514|NCT00235989|O4|Outcome|ET: IFNB-1b 250 mcg => 500 mcg|Extension Treatment 250 mcg increased to 500 mcg
1217515|NCT00235989|O3|Outcome|ET: IFNB-1b 500 mcg => 500 mcg|Extension Treatment 500 mcg continued
1217516|NCT00235989|O2|Outcome|ET: IFNB-1b 500 mcg => 250 mcg|Extension Treatment 500 mcg reduced to 250 mcg
1217517|NCT00235989|O1|Outcome|ET: IFNB-1b 250 mcg => 250 mcg|Extension Treatment 250 mcg continued
1217518|NCT00235989|E4|Reported Event|ET: IFNB-1b 250 mcg => 500 mcg|Extension Treatment 250 mcg increased to 500 mcg
1217519|NCT00235989|E3|Reported Event|ET: IFNB-1b 500 mcg => 500 mcg|Extension Treatment 500 mcg continued
1217520|NCT00235989|E2|Reported Event|ET: IFNB-1b 500 mcg => 250 mcg|Extension Treatment 500 mcg reduced to 250 mcg
1217521|NCT00235989|E1|Reported Event|ET: IFNB-1b 250 mcg => 250 mcg|Extension Treatment 250 mcg continued
1217522|NCT00235872|B1|Baseline|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
1217523|NCT00235872|P1|Participant Flow|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
1217524|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
1217525|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
1217526|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
1217527|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
1217528|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
1217529|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
1217530|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
1217531|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
1217532|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
1217533|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
1217534|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
1217535|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
1217536|NCT00235872|E1|Reported Event|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
1217537|NCT00235833|B1|Baseline|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
1217538|NCT00235833|P1|Participant Flow|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
1217539|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
1217540|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
1217541|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
1234737|NCT00138645|O1|Outcome|MicroDiet|MicroDiet
1217542|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
1217543|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
1217544|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
1217545|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
1217546|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
1217547|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
1217548|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
1217549|NCT00235833|E1|Reported Event|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
1217550|NCT00235755|B4|Baseline|Total|Total of all reporting groups
1217551|NCT00235755|B3|Baseline|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
1217552|NCT00235755|B2|Baseline|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
1217553|NCT00235755|B1|Baseline|Placebo - Double Blind (DB) Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 milligrams (mg) and 100 mg were administered orally thrice a day (TID) during the 4-week Titration Phase and the 12-week Maintenance Phase
1217554|NCT00235755|P3|Participant Flow|Retigabine 300 mg TID|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks. Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the 12-week Maintenance Phase.
1217555|NCT00235755|P2|Participant Flow|Retigabine 200 mg TID|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks. Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the 12-week Maintenance Phase.
1217556|NCT00235755|P1|Participant Flow|Placebo|Matching placebo tablets of dummy strengths of 50 milligrams (mg) and 100 mg were administered orally thrice a day (TID) during the 4-week Titration Phase. Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 12-week Maintenance Phase.
1217557|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
1217558|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
1217559|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
1217560|NCT00235755|O3|Outcome|Retigabine 300 mg TID: Maintenance Phase|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the 12-week Maintenance Phase
1217561|NCT00235755|O2|Outcome|Retigabine 200 mg TID: Maintenance Phase|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the 12-week Maintenance Phase
1217562|NCT00235755|O1|Outcome|Placebo: Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 12-week Maintenance Phase
1217619|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12 week Maintenance Phase
1219394|NCT00224042|P2|Participant Flow|Oral Iron|
1217563|NCT00235755|O6|Outcome|Retigabine 300 mg TID - Transition Phase|Participants receiving retigabine 300 mg TID during the Maintenance Phase continued receiving retigabine 300 mg TID during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). Placebo doses were administered to maintain the blinding and were increased weekly by a maximum of 150 mg per day
1217564|NCT00235755|O5|Outcome|Retigabine 200 mg TID - Transition Phase|Participants receiving retigabine 200 mg TID during the Maintenance Phase were titrated to a target dose of 300 mg TID retigabine during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). Retigabine doses were increased weekly by a maximum of 150 mg per day
1217565|NCT00235755|O4|Outcome|Placebo - Transition Phase|Participants receiving placebo during the Maintenance Phase were titrated to a target dose of retigabine 300 mg TID during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). The starting dose for retigabine titration was 100 mg TID and was increased weekly by a maximum of 150 mg per day
1235429|NCT00134784|B1|Baseline|Placebo Group|Subjects on placebo
1217566|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
1217567|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
1217568|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
1217569|NCT00235755|O6|Outcome|Retigabine 300 mg TID - Transition Phase|Participants receiving retigabine 300 mg TID during the Maintenance Phase continued receiving retigabine 300 mg TID during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). Placebo doses were administered to maintain the blinding and were increased weekly by a maximum of 150 mg per day
1217570|NCT00235755|O5|Outcome|Retigabine 200 mg TID - Transition Phase|Participants receiving retigabine 200 mg TID during the Maintenance Phase were titrated to a target dose of 300 mg TID retigabine during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). Retigabine doses were increased weekly by a maximum of 150 mg per day
1217571|NCT00235755|O4|Outcome|Placebo - Transition Phase|Participants receiving placebo during the Maintenance Phase were titrated to a target dose of retigabine 300 mg TID during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). The starting dose for retigabine titration was 100 mg TID and was increased weekly by a maximum of 150 mg per day
1217572|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
1217573|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
1217574|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
1217575|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
1217576|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
1217577|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
1217578|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
1217579|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
1217580|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
1217650|NCT00235716|O4|Outcome|Placebo|Matching placebo pills for vitamin E and memantine
1217581|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
1217582|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
1217583|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
1217709|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217584|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
1217585|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
1217586|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
1217587|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
1217588|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
1217589|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
1217590|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
1217591|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
1217592|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
1217593|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
1217594|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
1217595|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
1217596|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
1217597|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
1217598|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
1217599|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
1217600|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
1217601|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
1217602|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
1217603|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
1217604|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
1217605|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
1217606|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
1217607|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
1217608|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
1217609|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
1217610|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
1217611|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
1217612|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
1217613|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
1217614|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
1217615|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
1217616|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
1217617|NCT00235755|O3|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
1217618|NCT00235755|O2|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
1217620|NCT00235755|O3|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
1217621|NCT00235755|O2|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
1217622|NCT00235755|O1|Outcome|Placebo - Double Blind (DB) Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 milligrams (mg) and 100 mg were administered orally thrice a day (TID) during the 4-week Titration Phase and the 12-week Maintenance Phase
1217623|NCT00235755|E6|Reported Event|Retigabine 300 mg TID - Transition Phase|Participants receiving retigabine 300 mg TID during the Maintenance Phase continued receiving retigabine 300 mg TID during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). Placebo doses were administered to maintain the blinding and were increased weekly by a maximum of 150 mg per day
1217624|NCT00235755|E5|Reported Event|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
1217625|NCT00235755|E4|Reported Event|Retigabine 200 mg TID - Transition Phase|Participants receiving retigabine 200 mg TID during the Maintenance Phase were titrated to a target dose of 300 mg TID retigabine during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). Retigabine doses were increased weekly by a maximum of 150 mg per day
1217626|NCT00235755|E3|Reported Event|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
1217627|NCT00235755|E2|Reported Event|Placebo - Transition Phase|Participants receiving placebo during the Maintenance Phase were titrated to a target dose of retigabine 300 mg TID during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). The starting dose for retigabine titration was 100 mg TID and was increased weekly by a maximum of 150 mg per day
1217628|NCT00235755|E1|Reported Event|Placebo - Double Blind (DB) Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 milligrams (mg) and 100 mg were administered orally thrice a day (TID) during the 4-week Titration Phase and the 12-week Maintenance Phase
1217629|NCT00235716|B5|Baseline|Total|Total of all reporting groups
1217630|NCT00235716|B4|Baseline|Placebo|Matching placebo pills for vitamin E and memantine
1217631|NCT00235716|B3|Baseline|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
1217632|NCT00235716|B2|Baseline|Memantine (Namenda)|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
1217633|NCT00235716|B1|Baseline|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
1217634|NCT00235716|P4|Participant Flow|Placebo|Matching placebo pills for vitamin E and memantine
1217635|NCT00235716|P3|Participant Flow|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
1217636|NCT00235716|P2|Participant Flow|Memantine (Namenda)|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
1217637|NCT00235716|P1|Participant Flow|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
1217638|NCT00235716|O4|Outcome|Placebo|Matching placebo pills for vitamin E and memantine
1217639|NCT00235716|O3|Outcome|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
1217640|NCT00235716|O2|Outcome|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
1217641|NCT00235716|O1|Outcome|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
1217642|NCT00235716|O4|Outcome|Placebo|Matching placebo pills for vitamin E and memantine
1217643|NCT00235716|O3|Outcome|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
1217644|NCT00235716|O2|Outcome|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
1217645|NCT00235716|O1|Outcome|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
1217646|NCT00235716|O4|Outcome|Placebo|Matching placebo pills for vitamin E and memantine
1217647|NCT00235716|O3|Outcome|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
1217648|NCT00235716|O2|Outcome|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
1217649|NCT00235716|O1|Outcome|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
1217651|NCT00235716|O3|Outcome|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
1217652|NCT00235716|O2|Outcome|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
1217653|NCT00235716|O1|Outcome|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
1217654|NCT00235716|O4|Outcome|Placebo|Matching placebo pills for vitamin E and memantine
1217655|NCT00235716|O3|Outcome|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
1217656|NCT00235716|O2|Outcome|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
1217839|NCT00235391|B7|Baseline|Total|Total of all reporting groups
1235662|NCT00133978|O2|Outcome|Antioxidants|Antioxidant supplementation
1217657|NCT00235716|O1|Outcome|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
1217658|NCT00235716|O4|Outcome|Placebo|Matching placebo pills for vitamin E and memantine
1217659|NCT00235716|O3|Outcome|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
1217660|NCT00235716|O2|Outcome|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
1217661|NCT00235716|O1|Outcome|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
1217662|NCT00235716|O4|Outcome|Placebo|Matching placebo pills for vitamin E and memantine
1217663|NCT00235716|O3|Outcome|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
1217664|NCT00235716|O2|Outcome|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
1217665|NCT00235716|O1|Outcome|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
1217666|NCT00235716|E4|Reported Event|Placebo|Matching placebo pills for vitamin E and memantine
1217667|NCT00235716|E3|Reported Event|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
1217668|NCT00235716|E2|Reported Event|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
1217669|NCT00235716|E1|Reported Event|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
1217670|NCT00235573|B1|Baseline|All Study Participants|All study participants received the same treatment of 3 doses of 9 micrograms of vitamin B12 at 6 hour intervals on day 1.
1217671|NCT00235573|P1|Participant Flow|All Study Participants|All study participants received the same treatment of 3 doses of 9 micrograms of vitamin B12 at 6 hour intervals on day 1.
1217672|NCT00235573|O1|Outcome|Vitamin B12 Group|All subjects received the same treatment of 3 doses of 9 micrograms of vitamin B12 at 6 hour intervals on day 1.
1217673|NCT00235573|E1|Reported Event|All Study Participants|All study participants received the same treatment of 3 doses of 9 micrograms of vitamin B12 at 6 hour intervals on day 1.
1217674|NCT00235456|B3|Baseline|Total|Total of all reporting groups
1217675|NCT00235456|B2|Baseline|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
1217676|NCT00235456|B1|Baseline|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
1217677|NCT00235456|P2|Participant Flow|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
1217678|NCT00235456|P1|Participant Flow|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
1217679|NCT00235456|O2|Outcome|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
1217680|NCT00235456|O1|Outcome|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
1217703|NCT00235443|P3|Participant Flow|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1218804|NCT00228943|E1|Reported Event|Full Strength Acute Tryptophan Depletion|No adverse events
1217681|NCT00235456|O2|Outcome|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
1217682|NCT00235456|O1|Outcome|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
1217971|NCT00234286|O2|Outcome|Post-Intervention|Number of Patients who died in ICU Post-Intervention
1217683|NCT00235456|O2|Outcome|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
1217684|NCT00235456|O1|Outcome|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
1217685|NCT00235456|O2|Outcome|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
1217686|NCT00235456|O1|Outcome|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
1217687|NCT00235456|O2|Outcome|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
1217688|NCT00235456|O1|Outcome|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
1217689|NCT00235456|O2|Outcome|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
1217690|NCT00235456|O1|Outcome|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
1217691|NCT00235456|E2|Reported Event|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
1217692|NCT00235456|E1|Reported Event|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
1217693|NCT00235443|B7|Baseline|Total|Total of all reporting groups
1217694|NCT00235443|B6|Baseline|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217695|NCT00235443|B5|Baseline|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217696|NCT00235443|B4|Baseline|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217697|NCT00235443|B3|Baseline|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217698|NCT00235443|B2|Baseline|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217699|NCT00235443|B1|Baseline|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217700|NCT00235443|P6|Participant Flow|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217701|NCT00235443|P5|Participant Flow|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217702|NCT00235443|P4|Participant Flow|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217704|NCT00235443|P2|Participant Flow|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217705|NCT00235443|P1|Participant Flow|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217706|NCT00235443|O7|Outcome|Total|All modal dose groups combined
1217707|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217708|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217972|NCT00234286|O1|Outcome|Pre-Intervention|Number of Individuals who died in ICU Pre-Intervention
1217710|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217711|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217712|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217713|NCT00235443|O7|Outcome|Total|All modal dose groups combined
1217714|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217715|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217716|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217717|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217718|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217719|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217720|NCT00235443|O7|Outcome|Total|All modal dose groups combined
1217721|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217722|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217723|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217724|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217725|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217726|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217727|NCT00235443|O7|Outcome|Total|All modal dose groups combined
1217728|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217729|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217730|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217731|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217732|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217733|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217734|NCT00235443|O7|Outcome|Total|All modal dose groups combined
1217735|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217736|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217737|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217738|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217739|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217740|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217741|NCT00235443|O7|Outcome|Total|All modal dose groups combined
1217742|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217743|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217744|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217745|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217746|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217747|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217748|NCT00235443|O7|Outcome|Total|All modal dose groups combined
1217749|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217750|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217751|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217752|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217753|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217754|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217755|NCT00235443|O7|Outcome|Total|All modal dose groups combined
1217756|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217757|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217758|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217759|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217760|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217761|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217762|NCT00235443|O7|Outcome|Total|All modal dose groups combined
1217763|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217764|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217765|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217766|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217767|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217768|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217769|NCT00235443|O7|Outcome|Total|All modal dose groups combined
1217770|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217771|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217772|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217773|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217774|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217775|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217776|NCT00235443|O7|Outcome|Total|All modal dose groups combined
1217777|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217778|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217779|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217780|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217781|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217782|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217783|NCT00235443|O7|Outcome|Total|All modal dose groups combined
1217784|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217785|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217786|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217787|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217788|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217789|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217791|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217792|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217793|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217794|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217795|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1218109|NCT00233103|O2|Outcome|Placebo|Placebo for 10 weeks
1217796|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217797|NCT00235443|O7|Outcome|Total|All modal dose groups combined
1217798|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217799|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217800|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217801|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217802|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217803|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217804|NCT00235443|O7|Outcome|Total|All modal dose groups combined
1217805|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217806|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217807|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217808|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217809|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217810|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217811|NCT00235443|O7|Outcome|Total|All modal dose groups combined
1217812|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217813|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217814|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217815|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217816|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217817|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217818|NCT00235443|O7|Outcome|Total|All modal dose groups combined
1217819|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217820|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217821|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217822|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217823|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217824|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217825|NCT00235443|O7|Outcome|Total|All modal dose groups combined
1217826|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217827|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217828|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217829|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217830|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217831|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217832|NCT00235443|E7|Reported Event|Total|All modal dose groups combined
1217833|NCT00235443|E6|Reported Event|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217834|NCT00235443|E5|Reported Event|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217835|NCT00235443|E4|Reported Event|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217836|NCT00235443|E3|Reported Event|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217837|NCT00235443|E2|Reported Event|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217838|NCT00235443|E1|Reported Event|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
1217840|NCT00235391|B6|Baseline|≥ 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
1217841|NCT00235391|B5|Baseline|50 to < 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
1217842|NCT00235391|B4|Baseline|16 to < 50 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
1217843|NCT00235391|B3|Baseline|12 to < 16 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
1217844|NCT00235391|B2|Baseline|6 to < 12 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
1217845|NCT00235391|B1|Baseline|2 to < 6 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
1217846|NCT00235391|P6|Participant Flow|≥ 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
1217847|NCT00235391|P5|Participant Flow|50 to < 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
1217848|NCT00235391|P4|Participant Flow|16 to < 50 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
1217849|NCT00235391|P3|Participant Flow|12 to < 16 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
1217850|NCT00235391|P2|Participant Flow|6 to < 12 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
1217851|NCT00235391|P1|Participant Flow|2 to < 6 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
1217852|NCT00235391|O6|Outcome|≥ 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
1217853|NCT00235391|O5|Outcome|50 to < 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
1217854|NCT00235391|O4|Outcome|16 to < 50 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
1217855|NCT00235391|O3|Outcome|12 to < 16 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
1217856|NCT00235391|O2|Outcome|6 to < 12 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
1217857|NCT00235391|O1|Outcome|2 to < 6 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
1217858|NCT00235391|O6|Outcome|≥ 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
1217859|NCT00235391|O5|Outcome|50 to < 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
1217860|NCT00235391|O4|Outcome|16 to < 50 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
1217861|NCT00235391|O3|Outcome|12 to < 16 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
1217862|NCT00235391|O2|Outcome|6 to < 12 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
1217863|NCT00235391|O1|Outcome|2 to < 6 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
1217864|NCT00235391|E1|Reported Event|All Participants|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
1217865|NCT00235326|B3|Baseline|Total|Total of all reporting groups
1217866|NCT00235326|B2|Baseline|Exposed to Gastroenteritis|
1217867|NCT00235326|B1|Baseline|Unexposed to Gastroenteritis|
1217868|NCT00235326|P2|Participant Flow|Exposed to Gastroenteritis|
1217872|NCT00234884|B1|Baseline|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
1217873|NCT00234884|P1|Participant Flow|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
1217874|NCT00234884|O1|Outcome|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
1217875|NCT00234884|O1|Outcome|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
1217876|NCT00234884|O1|Outcome|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
1217877|NCT00234884|O1|Outcome|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
1217878|NCT00234884|O1|Outcome|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
1217879|NCT00234884|E1|Reported Event|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
1217880|NCT00234832|B3|Baseline|Total|Total of all reporting groups
1217881|NCT00234832|B2|Baseline|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
1217882|NCT00234832|B1|Baseline|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
1217883|NCT00234832|P2|Participant Flow|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
1217884|NCT00234832|P1|Participant Flow|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
1217885|NCT00234832|O2|Outcome|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
1217886|NCT00234832|O1|Outcome|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
1217887|NCT00234832|O2|Outcome|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
1217888|NCT00234832|O1|Outcome|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
1217889|NCT00234832|O2|Outcome|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
1217890|NCT00234832|O1|Outcome|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
1217891|NCT00234832|O2|Outcome|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
1217892|NCT00234832|O1|Outcome|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
1217893|NCT00234832|O2|Outcome|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
1217894|NCT00234832|O1|Outcome|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
1217895|NCT00234832|O2|Outcome|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
1217896|NCT00234832|O1|Outcome|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
1217897|NCT00234832|O8|Outcome|CV + DM Randomized to Placebo|Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and with a history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.
1217898|NCT00234832|O7|Outcome|CV + DM Randomized to Sibutramine|Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and with a history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.
1217899|NCT00234832|O6|Outcome|CV Only Randomized to Placebo|Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, but no history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.
1217969|NCT00234286|O2|Outcome|Post-Intervention|Individuals who died with a nasogastric tube post-intervention
1217970|NCT00234286|O1|Outcome|Pre-Intervention|Individuals who died with a nasogastric tube pre-intervention
1217900|NCT00234832|O5|Outcome|CV Only Randomized to Sibutramine|Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, but no history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.
1217901|NCT00234832|O4|Outcome|DM Only Randomized to Placebo|Subjects with a history of type 2 DM with at least one other risk factor (i.e., hypertension controlled on medication, dyslipidemia, current cigarette smoking, diabetic nephropathy with evidence of microalbuminuria), but no history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.
1217902|NCT00234832|O3|Outcome|DM Only Randomized to Sibutramine|Subjects with a history of type 2 DM with at least one other risk factor (i.e., hypertension controlled on medication, dyslipidemia, current cigarette smoking, diabetic nephropathy with evidence of microalbuminuria), but no history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.
1217903|NCT00234832|O2|Outcome|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
1217904|NCT00234832|O1|Outcome|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
1217905|NCT00234832|E3|Reported Event|Randomized Placebo|Subjects who successfully completed a 6-week Lead-in Period and who were randomized to receive placebo plus standard care for weight management during the Treatment Period of the Randomizaiton Phase, and if placebo was prematurely discontinued, they received standard care for weight management during the Follow-up Period of the Randomization Phase.
1217906|NCT00234832|E2|Reported Event|Randomized Sibutramine|Subjects who successfully completed a 6-week Lead-in Period and who were randomized to receive sibutramine plus standard care for weight management during the Treatment Period of the Randomization Phase, and if sibutramine was prematurely discontinued, they received standard care for weight management during the Follow-up Period of the Randomization Phase.
1217907|NCT00234832|E1|Reported Event|Lead-in Period Sibutramine|Subjects who received sibutramine 10 mg QD plus standard care for weight management during a 6-week Lead-in Period.
1217908|NCT00234494|B1|Baseline|Single Group Assignment|"Cisplatin + Gemcitabine + Bevacizumab~Cisplatin: Cisplatin 70 mg/m2, day 1~Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8~Bevacizumab: Bevacizumab 15mg/kg, day 1"
1217909|NCT00234494|P1|Participant Flow|Single Group Assignment|"Cisplatin + Gemcitabine + Bevacizumab~Cisplatin: Cisplatin 70 mg/m2, day 1~Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8~Bevacizumab: Bevacizumab 15mg/kg, day 1"
1217910|NCT00234494|O1|Outcome|Single Group Assignment|"Cisplatin + Gemcitabine + Bevacizumab~Cisplatin: Cisplatin 70 mg/m2, day 1~Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8~Bevacizumab: Bevacizumab 15mg/kg, day 1"
1217911|NCT00234494|O1|Outcome|Single Group Assignment|"Cisplatin + Gemcitabine + Bevacizumab~Cisplatin: Cisplatin 70 mg/m2, day 1~Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8~Bevacizumab: Bevacizumab 15mg/kg, day 1"
1217912|NCT00234494|O1|Outcome|Single Group Assignment|"Cisplatin + Gemcitabine + Bevacizumab~Cisplatin: Cisplatin 70 mg/m2, day 1~Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8~Bevacizumab: Bevacizumab 15mg/kg, day 1"
1217913|NCT00234494|O1|Outcome|Single Group Assignment|"Cisplatin + Gemcitabine + Bevacizumab~Cisplatin: Cisplatin 70 mg/m2, day 1~Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8~Bevacizumab: Bevacizumab 15mg/kg, day 1"
1217914|NCT00234494|E1|Reported Event|Single Group Assignment|"Cisplatin + Gemcitabine + Bevacizumab~Cisplatin: Cisplatin 70 mg/m2, day 1~Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8~Bevacizumab: Bevacizumab 15mg/kg, day 1"
1217915|NCT00233519|B3|Baseline|Total|Total of all reporting groups
1217916|NCT00233519|B2|Baseline|Cohort 2-Three Escalating Doses of iPlex|N=9 Following approval of the safety monitoring committee who reviewed the data on the cohort 1, the second cohort received consecutive 8 week treatments of 0.5, 1.0, and 2.0 mg/kg/day of iPlex for a total of 24 weeks by self-administered subcuteanous injection.
1217917|NCT00233519|B1|Baseline|Cohort 1- Two Escalating Doses of iPlex|N=6 This group received self-administered subcuteanous injections of 0.5 mg/kg/day of iPlex for 8 weeks, followed by 1.0 mg/kg/day of iPlex for 16 weeks.
1217918|NCT00233519|P2|Participant Flow|Cohort 2-Three Escalating Doses of iPlex|N=9 Following approval of the safety monitoring committee who reviewed the data on the cohort 1, the second cohort received consecutive 8 week treatments of 0.5, 1.0, and 2.0 mg/kg/day of iPlex for a total of 24 weeks by self-administered subcuteanous injection.
1217919|NCT00233519|P1|Participant Flow|Cohort 1- Two Escalating Doses of iPlex|N=6 This group received self-administered subcuteanous injections of 0.5 mg/kg/day of iPlex for 8 weeks, followed by 1.0 mg/kg/day of iPlex for 16 weeks.
1217920|NCT00233519|O2|Outcome|Cohort 2-Three Escalating Doses of iPlex|N=9 Following approval of the safety monitoring committee who reviewed the data on the cohort 1, the second cohort received consecutive 8 week treatments of 0.5, 1.0, and 2.0 mg/kg/day of iPlex for a total of 24 weeks by self-administered subcuteanous injection.
1217962|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with antipsychotic medication ordered pre-intervention
1217921|NCT00233519|O1|Outcome|Cohort 1- Two Escalating Doses of iPlex|N=6 This group received self-administered subcuteanous injections of 0.5 mg/kg/day of iPlex for 8 weeks, followed by 1.0 mg/kg/day of iPlex for 16 weeks.
1217922|NCT00233519|E2|Reported Event|Cohort 2-Three Escalating Doses of iPlex|N=9 Following approval of the safety monitoring committee who reviewed the data on the cohort 1, the second cohort received consecutive 8 week treatments of 0.5, 1.0, and 2.0 mg/kg/day of iPlex for a total of 24 weeks by self-administered subcuteanous injection.
1217923|NCT00233519|E1|Reported Event|Cohort 1- Two Escalating Doses of iPlex|N=6 This group received self-administered subcuteanous injections of 0.5 mg/kg/day of iPlex for 8 weeks, followed by 1.0 mg/kg/day of iPlex for 16 weeks.
1217924|NCT00233454|B1|Baseline|Midostaurin|"100 mg midostaurin twice daily as oral capsules~Midostaurin: Midostaurin is a broad-spectrum protein kinase inhibitor, acting on conventional PKC isoforms (α, β, γ); PDFRβ; VEGFR2; Syk; PKCη; Flk-1; Flt3; Cdk1/B; PKA; c-Kit; c-Fgr; c-Src; VEGFR1; and EGFR"
1217925|NCT00233454|P1|Participant Flow|Midostaurin|"100 mg midostaurin twice daily as oral capsules~Midostaurin: Midostaurin is a broad-spectrum protein kinase inhibitor, acting on conventional PKC isoforms (α, β, γ); PDFRβ; VEGFR2; Syk; PKCη; Flk-1; Flt3; Cdk1/B; PKA; c-Kit; c-Fgr; c-Src; VEGFR1; and EGFR"
1217926|NCT00233454|O1|Outcome|Midostaurin|"100 mg midostaurin twice daily as oral capsules~Midostaurin: Midostaurin is a broad-spectrum protein kinase inhibitor, acting on conventional PKC isoforms (α, β, γ); PDFRβ; VEGFR2; Syk; PKCη; Flk-1; Flt3; Cdk1/B; PKA; c-Kit; c-Fgr; c-Src; VEGFR1; and EGFR"
1217927|NCT00233454|O1|Outcome|Midostaurin|"100 mg midostaurin twice daily as oral capsules~Midostaurin: Midostaurin is a broad-spectrum protein kinase inhibitor, acting on conventional PKC isoforms (α, β, γ); PDFRβ; VEGFR2; Syk; PKCη; Flk-1; Flt3; Cdk1/B; PKA; c-Kit; c-Fgr; c-Src; VEGFR1; and EGFR"
1217928|NCT00233454|E1|Reported Event|Midostaurin|"100 mg midostaurin twice daily as oral capsules~Midostaurin: Midostaurin is a broad-spectrum protein kinase inhibitor, acting on conventional PKC isoforms (α, β, γ); PDFRβ; VEGFR2; Syk; PKCη; Flk-1; Flt3; Cdk1/B; PKA; c-Kit; c-Fgr; c-Src; VEGFR1; and EGFR"
1217929|NCT00233402|B3|Baseline|Total|Total of all reporting groups
1217930|NCT00233402|B2|Baseline|Hexvix Fluorescence Cystoscopy|Standard White Light and Hexvix Fluorescence Cystoscopy
1217931|NCT00233402|B1|Baseline|Comparator|Standard White Light Cystoscopy
1217932|NCT00233402|P2|Participant Flow|Hexvix Fluorescence Cystoscopy|Standard White Light and Hexvix Fluorescence Cystoscopy
1217933|NCT00233402|P1|Participant Flow|Comparator|Standard White Light Cystoscopy
1217934|NCT00233402|O1|Outcome|Hexvix Fluorescence Cystoscopy|Standard White Light and Hexvix Fluorescence Cystoscopy
1217935|NCT00233402|O2|Outcome|White Light Group|
1217936|NCT00233402|O1|Outcome|Hexvix Group|
1217937|NCT00233402|O2|Outcome|White Light Group|
1217938|NCT00233402|O1|Outcome|Hexvix Group|
1217939|NCT00233402|O2|Outcome|White Light Group|
1217940|NCT00233402|O1|Outcome|Hexvix Group|The primary endpoint was assessed from patients randomized to the Hexvix group only
1217941|NCT00233402|E2|Reported Event|Hexvix Fluorescence Cystoscopy|Standard White Light and Hexvix Fluorescence Cystoscopy
1217942|NCT00233402|E1|Reported Event|Comparator|Standard White Light Cystoscopy
1217943|NCT00234286|B1|Baseline|Arm 1|"Comfort care education intervention, consisting of on-site staff training together with an electronic order set for palliative care and educational materials~Comfort care education intervention: Comfort care education intervention, consisting of on-site staff training together with an electronic order set for palliative care and educational materials"
1217944|NCT00234286|P1|Participant Flow|BEACON Intervention|"Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials~Comfort care education intervention: Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials"
1217945|NCT00234286|O2|Outcome|Post-Intervention|Individuals with documented Palliative Care Consultation pre-intervention in their medical record
1217946|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with documented Palliative Care Consultation pre-intervention in their medical record
1217947|NCT00234286|O2|Outcome|Post-Intervention|Individuals with Advanced Directive post-intervention based on abstraction of medical record
1217948|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with Advanced Directive pre-intervention based on abstraction of medical record
1217949|NCT00234286|O2|Outcome|Post-Intervention|Individuals with Pastoral Care visit post-intervention based on abstraction of medical record
1217950|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with Pastoral Care Visit pre-intervention based on abstraction of medical record
1217951|NCT00234286|O2|Outcome|Post-Intervention|Individuals with Sublingual administration of medication during post-intervention based on abstraction of medical record
1217952|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with Sublingual administration of medication during pre-intervention based on abstraction of medical record
1217953|NCT00234286|O2|Outcome|Post-Intervention|Individuals with Administration of scopolamine (for death rattle) during post -intervention based on abstraction of medical record
1217954|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with Administration of scopolamine (for death rattle) during pre-intervention based on abstraction of medical record
1217955|NCT00234286|O2|Outcome|Post-Intervention|Individuals with Administration of benzodiazepine medication during post-intervention based on abstraction of medical record
1217956|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with Administration of benzodiazepine medication during pre-intervention based on abstraction of medical record
1217957|NCT00234286|O2|Outcome|Post-Intervention|Individuals with Order for benzodiazepine medication during post-intervention period based on abstraction of medical record
1217958|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with Order for benzodiazepine medication during pre-intervention period based on abstraction of medical record
1217959|NCT00234286|O2|Outcome|Post-Intervention|Individuals with Administration of antipsychotic medication post-intervention
1217960|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with Administration of antipsychotic medication pre-intervention
1217961|NCT00234286|O2|Outcome|Post-Intervention|Individuals with antipsychotic medication ordered post-intervention
1217963|NCT00234286|O2|Outcome|Post-intervention|Individuals who received opioid medication post-intervention
1217964|NCT00234286|O1|Outcome|Pre-Intervention|Individuals who received opioid medication pre-intervention
1217965|NCT00234286|O2|Outcome|Post-Intervention|Individuals who died with restraints during post-intervention
1217966|NCT00234286|O1|Outcome|Pre-Intervention|Individuals who died with restraints during pre-intervention
1217967|NCT00234286|O2|Outcome|Post-Intervention|Individuals who died with an intravenous line post-intervention
1217968|NCT00234286|O1|Outcome|Pre-Intervention|Individuals who died with an intravenous line pre-intervention
1235663|NCT00133978|O1|Outcome|Glutamine|Glutamine supplementation
1217973|NCT00234286|O2|Outcome|Post-Intervention|"Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials~Comfort care education intervention: Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials"
1217974|NCT00234286|O1|Outcome|Pre-Intervention|"Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials~Comfort care education intervention: Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials"
1217975|NCT00234286|O2|Outcome|Post-Intervention|"Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials~Comfort care education intervention: Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials"
1217976|NCT00234286|O1|Outcome|Pre-Intervention|"Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials~Comfort care education intervention: Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials"
1217977|NCT00234286|E1|Reported Event|Arm 1|Arm 1: Comfort care education intervention, consisting of intensive, on-site staff training
1217978|NCT00234104|B5|Baseline|Total|Total of all reporting groups
1217979|NCT00234104|B4|Baseline|45 mg of OPC-41061|OPC-41061 45 mg/day
1217980|NCT00234104|B3|Baseline|30 mg of OPC-41061|OPC-41061 30 mg/day
1217981|NCT00234104|B2|Baseline|15 mg of OPC-41061|OPC-41061 15 mg/day
1217982|NCT00234104|B1|Baseline|Placebo|OPC-41061 0 mg/day
1217983|NCT00234104|P4|Participant Flow|45 mg of OPC-41061|OPC-41061 45 mg/day
1217984|NCT00234104|P3|Participant Flow|30 mg of OPC-41061|OPC-41061 30 mg/day
1217985|NCT00234104|P2|Participant Flow|15 mg of OPC-41061|OPC-41061 15 mg/day
1217986|NCT00234104|P1|Participant Flow|Placebo|OPC-41061 0 mg/day
1217987|NCT00234104|O4|Outcome|45 mg of OPC-41061|OPC-41061 45 mg/day
1217988|NCT00234104|O3|Outcome|30 mg of OPC-41061|OPC-41061 30 mg/day
1217989|NCT00234104|O2|Outcome|15 mg of OPC-41061|OPC-41061 15 mg/day
1217990|NCT00234104|O1|Outcome|Placebo|OPC-41061 0 mg/day
1217991|NCT00234104|E4|Reported Event|45 mg of OPC-41061|OPC-41061 45 mg/day
1217992|NCT00234104|E3|Reported Event|30 mg of OPC-41061|OPC-41061 30 mg/day
1217993|NCT00234104|E2|Reported Event|15 mg of OPC-41061|OPC-41061 15 mg/day
1217994|NCT00234104|E1|Reported Event|Placebo|OPC-41061 0 mg/day
1217995|NCT00234078|B5|Baseline|Total|Total of all reporting groups
1217996|NCT00234078|B4|Baseline|Placebo|0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
1217997|NCT00234078|B3|Baseline|2% OPC-12759|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
1217998|NCT00234078|B2|Baseline|1% OPC-12759|1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
1217999|NCT00234078|B1|Baseline|0.5% OPC-12759|0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
1218000|NCT00234078|P4|Participant Flow|Placebo|0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
1218001|NCT00234078|P3|Participant Flow|2% OPC-12759|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
1218002|NCT00234078|P2|Participant Flow|1% OPC-12759|1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
1218003|NCT00234078|P1|Participant Flow|0.5% OPC-12759|0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
1218004|NCT00234078|O4|Outcome|Placebo|0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
1218005|NCT00234078|O3|Outcome|2% OPC-12759|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
1218006|NCT00234078|O2|Outcome|1% OPC-12759|1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
1218007|NCT00234078|O1|Outcome|0.5% OPC-12759|0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
1218008|NCT00234078|O4|Outcome|Placebo|0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
1218009|NCT00234078|O3|Outcome|2% OPC-12759|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
1218010|NCT00234078|O2|Outcome|1% OPC-12759|1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
1218011|NCT00234078|O1|Outcome|0.5% OPC-12759|0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
1218012|NCT00234078|O4|Outcome|Placebo|0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
1218013|NCT00234078|O3|Outcome|2% OPC-12759|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
1218014|NCT00234078|O2|Outcome|1% OPC-12759|1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
1218015|NCT00234078|O1|Outcome|0.5% OPC-12759|0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
1218016|NCT00234078|O4|Outcome|Placebo|0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
1218017|NCT00234078|O3|Outcome|2% OPC-12759|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
1218018|NCT00234078|O2|Outcome|1% OPC-12759|1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
1218019|NCT00234078|O1|Outcome|0.5% OPC-12759|0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
1218020|NCT00234078|E4|Reported Event|Placebo|0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
1218021|NCT00234078|E3|Reported Event|2% OPC-12759|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
1218022|NCT00234078|E2|Reported Event|1% OPC-12759|1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
1218023|NCT00234078|E1|Reported Event|0.5% OPC-12759|0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
1218024|NCT00234065|B3|Baseline|Total|Total of all reporting groups
1218025|NCT00234065|B2|Baseline|Aspirin|Aspirin, oral tablet, 81 mg aspirin
1218026|NCT00234065|B1|Baseline|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
1218027|NCT00234065|P2|Participant Flow|Aspirin|Aspirin, oral tablet, 81 mg aspirin
1218028|NCT00234065|P1|Participant Flow|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
1218029|NCT00234065|O2|Outcome|Aspirin|Aspirin, oral tablet, 81 mg aspirin
1218030|NCT00234065|O1|Outcome|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
1218031|NCT00234065|O2|Outcome|Aspirin|Aspirin, oral tablet, 81 mg aspirin
1218032|NCT00234065|O1|Outcome|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
1218033|NCT00234065|O2|Outcome|Aspirin|Aspirin, oral tablet, 81 mg aspirin
1218034|NCT00234065|O1|Outcome|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
1218035|NCT00234065|O2|Outcome|Aspirin|Aspirin, oral tablet, 81 mg aspirin
1218036|NCT00234065|O1|Outcome|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
1218037|NCT00234065|O2|Outcome|Aspirin|Aspirin, oral tablet, 81 mg aspirin
1218038|NCT00234065|O1|Outcome|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
1218039|NCT00234065|O2|Outcome|Aspirin|Aspirin, oral tablet, 81 mg aspirin
1218040|NCT00234065|O1|Outcome|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
1218041|NCT00234065|E2|Reported Event|Aspirin|Aspirin, oral tablet, 81 mg aspirin
1218042|NCT00234065|E1|Reported Event|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
1218043|NCT00234039|B1|Baseline|Intravesical Gemcitabine|Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
1218044|NCT00234039|P1|Participant Flow|Intravesical Gemcitabine|Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
1218045|NCT00234039|O1|Outcome|Intravesical Gemcitabine|Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
1218046|NCT00234039|O1|Outcome|Intravesical Gemcitabine|Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
1218047|NCT00234039|O1|Outcome|Intravesical Gemcitabine|Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
1218048|NCT00234039|O1|Outcome|Intravesical Gemcitabine|Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
1218049|NCT00234039|E1|Reported Event|Intravesical Gemcitabine|Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
1218050|NCT00233987|B1|Baseline|High-dose Therapy Plus Tandem Transplant|Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
1218051|NCT00233987|P1|Participant Flow|High-dose Therapy Plus Tandem Transplant|Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either Total Body Irradiation(TBI)-based or 1,3-bis (2-chloroethyl)-1-nitrosourea(BCNU)-based high-dose therapy followed by infusion of at least 2 million cluster of differentiation 34 positive (CD34+) cells.
1218052|NCT00233987|O1|Outcome|High-dose Therapy Plus Tandem Transplant|Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
1218053|NCT00233987|O1|Outcome|High-dose Therapy Plus Tandem Transplant|Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
1218054|NCT00233987|O1|Outcome|High-dose Therapy Plus Tandem Transplant|Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
1218055|NCT00233987|O1|Outcome|High-dose Therapy Plus Tandem Transplant|Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
1218929|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
1218056|NCT00233987|E1|Reported Event|High-dose Therapy Plus Tandem Transplant|Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
1218057|NCT00233948|B3|Baseline|Total|Total of all reporting groups
1218058|NCT00233948|B2|Baseline|Phase II|Oral Nelfinavir at 3000 mg bid
1218059|NCT00233948|B1|Baseline|Phase I|Phase I dose escalation portion of the study. Initial dose of oral Nelfinavir was 1250 mg bid with escalation to the MTD at 4250 mg bid using a standard 3+3 dose escalation scheme.
1218060|NCT00233948|P6|Participant Flow|Phase II|Oral Nelfinavir at 3000mg bid
1218061|NCT00233948|P5|Participant Flow|Phase I: Dose Level V|Oral Nelfinavir at 4250mg bid.
1218062|NCT00233948|P4|Participant Flow|Phase I: Dose Level IV|Oral Nelfinavir at 3000mg bid.
1218063|NCT00233948|P3|Participant Flow|Phase I: Dose Level III|Oral Nelfinavir at 2125mg bid.
1218064|NCT00233948|P2|Participant Flow|Phase I: Dose Level II|Oral Nelfinavir at 1500mg bid.
1218065|NCT00233948|P1|Participant Flow|Phase I: Dose Level 1|Oral Nelfinavir at 1250mg bid.
1218066|NCT00233948|O1|Outcome|Phase II|Oral Nelfinavir at 3000 mg bid
1218067|NCT00233948|O1|Outcome|Phase I|All patients enrolled on the Phase I (dose-finding) portion of the study.
1218068|NCT00233948|O5|Outcome|Phase I: Dose Level V|Oral Nelfinavir at 4250mg bid.
1218069|NCT00233948|O4|Outcome|Phase I: Dose Level IV|Oral Nelfinavir at 3000mg bid.
1218070|NCT00233948|O3|Outcome|Phase I: Dose Level III|Oral Nelfinavir at 2125mg bid.
1218071|NCT00233948|O2|Outcome|Phase I: Dose Level II|Oral Nelfinavir at 1500mg bid.
1218072|NCT00233948|O1|Outcome|Phase I: Dose Level I|Oral Nelfinavir at 1250mg bid.
1218073|NCT00233948|E6|Reported Event|Phase II|Oral Nelfinavir at 3000 mg bid
1218074|NCT00233948|E5|Reported Event|Phase I: Dose Level V|Oral Nelfinavir at 4250mg bid.
1218075|NCT00233948|E4|Reported Event|Phase I: Dose Level IV|Oral Nelfinavir at 3000mg bid.
1218076|NCT00233948|E3|Reported Event|Phase I: Dose Level III|Oral Nelfinavir at 2125mg bid.
1218077|NCT00233948|E2|Reported Event|Phase I: Dose Level II|Oral Nelfinavir at 1500mg bid.
1218078|NCT00233948|E1|Reported Event|Phase I: Dose Level I|Oral Nelfinavir at 1250mg bid.
1218079|NCT00233324|B5|Baseline|Total|Total of all reporting groups
1218080|NCT00233324|B4|Baseline|Early Surfactant and Higher Range Oxygen|Intubation and administration of surfactant by 1 hour of age and oxygen adminstered in higher range (91-95%)
1218081|NCT00233324|B3|Baseline|Early Surfactant and Lower Range Oxygen|Intubation and administration of surfactant by 1 hour of age and oxygen adminstered in lower range (85-90%)
1218082|NCT00233324|B2|Baseline|CPAP and Higher Range Oxygen|Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU and oxygen adminstered in higher range (91-95%)
1218083|NCT00233324|B1|Baseline|CPAP and Lower Range Oxygen|Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU and oxygen administered in lower range (85-90%)
1218084|NCT00233324|P4|Participant Flow|CPAP and Higher Range Oxygen|Continuous Positive Airway Pressure (CPAP) and 91-95% target oxygen saturation
1218085|NCT00233324|P3|Participant Flow|CPAP and Lower Range Oxygen|Continuous Positive Airway Pressure (CPAP) and 85-89% target oxygen saturation
1218086|NCT00233324|P2|Participant Flow|Early Surfactant and Higher Range Oxygen|Early Surfactant and 91-95% target oxygen saturation
1218087|NCT00233324|P1|Participant Flow|Early Surfactant and Lower Range Oxygen|Early Surfactant and 85-89% target oxygen saturation
1218088|NCT00233324|O4|Outcome|Higher Oxygen Saturation Target|SpO2 range (91% to 95%) until the infant is no longer requiring ventilatory support or oxygen.
1218089|NCT00233324|O3|Outcome|Lower Oxygen Saturation Target|SpO2 range (85% to 89%) until the infant is no longer requiring ventilatory support or oxygen.
1218090|NCT00233324|O2|Outcome|Surfactant|Intubation and administration of surfactant by 1 hour of age
1218091|NCT00233324|O1|Outcome|CPAP|Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU
1218092|NCT00233324|O2|Outcome|Higher Oxygen Saturation Target|SpO2 range (91% to 95%) until the infant is no longer requiring ventilatory support or oxygen.
1218093|NCT00233324|O1|Outcome|Lower Oxygen Saturation Target|SpO2 range (85% to 89%) until the infant is no longer requiring ventilatory support or oxygen.
1218094|NCT00233324|O2|Outcome|Surfactant|Intubation and administration of surfactant by 1 hour of age
1218095|NCT00233324|O1|Outcome|CPAP|Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU
1218096|NCT00233324|E4|Reported Event|CPAP and Higher Range Oxygen|Continuous Positive Airway Pressure (CPAP) and 91-95% target oxygen saturation
1218097|NCT00233324|E3|Reported Event|CPAP and Lower Range Oxygen|Continuous Positive Airway Pressure (CPAP) and 85-89% target oxygen saturation
1218098|NCT00233324|E2|Reported Event|Surfactant and Higher Range Oxygen|Early Surfactant and 91-95% target oxygen saturation
1218805|NCT00228917|B5|Baseline|Total|Total of all reporting groups
1218099|NCT00233324|E1|Reported Event|Surfactant and Lower Range Oxygen|Early Surfactant and 85-89% target oxygen saturation
1218100|NCT00233103|B3|Baseline|Total|Total of all reporting groups
1218101|NCT00233103|B2|Baseline|Placebo|Placebo for 10 weeks
1218102|NCT00233103|B1|Baseline|Sertraline|Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
1218103|NCT00233103|P2|Participant Flow|Placebo|Placebo for 10 weeks
1218104|NCT00233103|P1|Participant Flow|Sertraline|Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg) for 10 weeks
1218105|NCT00233103|O2|Outcome|Placebo|Placebo for 10 weeks
1218106|NCT00233103|O1|Outcome|Sertraline|Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
1218107|NCT00233103|O2|Outcome|Placebo|Placebo for 10 weeks
1218108|NCT00233103|O1|Outcome|Sertraline|Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
1218110|NCT00233103|O1|Outcome|Sertraline|Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
1218111|NCT00233103|O2|Outcome|Placebo|Placebo for 10 weeks
1218112|NCT00233103|O1|Outcome|Sertraline|Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
1218113|NCT00233103|E2|Reported Event|Placebo|Placebo for 10 weeks
1218114|NCT00233103|E1|Reported Event|Sertraline|Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
1218115|NCT00233090|B3|Baseline|Total|Total of all reporting groups
1218116|NCT00233090|B2|Baseline|Placebo|daily dose of placebo for four weeks
1218117|NCT00233090|B1|Baseline|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
1218118|NCT00233090|P2|Participant Flow|Placebo|daily dose of placebo for four weeks
1218119|NCT00233090|P1|Participant Flow|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
1218120|NCT00233090|O2|Outcome|Placebo|daily dose of placebo for four weeks
1218121|NCT00233090|O1|Outcome|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
1218122|NCT00233090|O2|Outcome|Placebo|daily dose of placebo for four weeks
1218123|NCT00233090|O1|Outcome|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
1218124|NCT00233090|O2|Outcome|Placebo|daily dose of placebo for four weeks
1218125|NCT00233090|O1|Outcome|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
1218126|NCT00233090|O2|Outcome|Placebo|daily dose of placebo for four weeks
1218127|NCT00233090|O1|Outcome|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
1218128|NCT00233090|O2|Outcome|Placebo|daily dose of placebo for four weeks
1218129|NCT00233090|O1|Outcome|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
1218130|NCT00233090|O2|Outcome|Placebo|daily dose of placebo for four weeks
1218131|NCT00233090|O1|Outcome|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
1218132|NCT00233090|O2|Outcome|Placebo|daily dose of placebo for four weeks
1218133|NCT00233090|O1|Outcome|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
1218134|NCT00233090|O2|Outcome|Placebo|daily dose of placebo for four weeks
1218135|NCT00233090|O1|Outcome|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
1218136|NCT00233090|E2|Reported Event|Placebo|daily dose of placebo for four weeks
1218137|NCT00233090|E1|Reported Event|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
1218138|NCT00233064|B3|Baseline|Total|Total of all reporting groups
1218139|NCT00233064|B2|Baseline|Lyophilized Palivizumab|Lyophilized Palivizumab, 15 mg/kg IM q30 days X 5
1218140|NCT00233064|B1|Baseline|Liquid Palivizumab|Liquid Palivizumab, 15 mg/kg IM q30 days X 5
1218141|NCT00233064|P2|Participant Flow|Lyophilized Palivizumab|Lyophilized Palivizumab, 15 mg/kg IM q30 days X 5
1218142|NCT00233064|P1|Participant Flow|Liquid Palivizumab|Liquid Palivizumab, 15 mg/kg IM q30 days X 5
1218143|NCT00233064|O3|Outcome|Combined Liquid/Lyophilized Palivizumab|
1218144|NCT00233064|O2|Outcome|Lyophilized Palivizumab|Lyophilized Palivizumab, 15 mg/kg IM q30 days X 5
1218145|NCT00233064|O1|Outcome|Liquid Palivizumab|Liquid Palivizumab, 15 mg/kg IM q30 days X 5
1218146|NCT00233064|E2|Reported Event|Lyophilized Palivizumab|Lyophilized Palivizumab, 15 mg/kg IM q30 days X 5
1218147|NCT00233064|E1|Reported Event|Liquid Palivizumab|Liquid Palivizumab, 15 mg/kg IM q30 days X 5
1218148|NCT00232739|B1|Baseline|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
1218149|NCT00232739|P1|Participant Flow|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
1218150|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
1218151|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
1218152|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
1218153|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
1218154|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
1218155|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
1218156|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
1218157|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
1218158|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
1218159|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
1218160|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
1218161|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
1218207|NCT00232596|O1|Outcome|Placebo - Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks
1218162|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
1218163|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
1218164|NCT00232739|E1|Reported Event|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
1218165|NCT00232596|B3|Baseline|Total|Total of all reporting groups
1218166|NCT00232596|B2|Baseline|Retigabine - DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
1218167|NCT00232596|B1|Baseline|Placebo - Double-blind (DB) Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 milligrams (mg), 100 mg, and 300 mg administered orally thrice a day (TID) for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
1218168|NCT00232596|P2|Participant Flow|Retigabine|Titration Phase: retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID with a starting daily dose of 300 mg/day (in 3 equally divided doses). The dose increased weekly by 150 mg/day (50 mg TID) for the 6 weeks of the Titration Phase to a target daily dose of 1200 mg/day (400 mg TID) by the beginning of Week 7 of treatment. Maintenance Phase: Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks in participants who tolerated this dose. Participants who could not tolerate the 1200 mg/day dose were allowed to reduce the dose to 1050 mg/day (350 mg TID) at the end of the first week and then maintain this dose for the remainder of the 12 weeks.
1218169|NCT00232596|P1|Participant Flow|Placebo|Titration Phase: matching placebo tablets of dummy strengths of 50 milligrams (mg), 100 mg, and 300 mg administered orally thrice a day (TID) for 6 weeks. Maintenance Phase: matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks.
1218170|NCT00232596|O2|Outcome|Retigabine DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
1218171|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
1218172|NCT00232596|O2|Outcome|Retigabine - DB Phase (Titration and Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
1218173|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration and Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
1218174|NCT00232596|O4|Outcome|Retigabine (DB Phase) and Retigabine (Transition Phase)|Participants on retigabine during the DB phase were administered retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a total daily dose of 1200 mg/day (400 mg TID) for 6 weeks
1218175|NCT00232596|O3|Outcome|Retigabine - DB Phase (Titration and Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
1218176|NCT00232596|O2|Outcome|Placebo (DB Phase) and Retigabine (Transition Phase)|Participants on placebo during the DB phase were administered retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a total daily dose of 1200 mg/day (400 mg TID) for 6 weeks
1218177|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration and Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
1218178|NCT00232596|O4|Outcome|Retigabine (DB Phase) and Retigabine (Transition Phase)|Participants on retigabine during the DB phase were administered retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a total daily dose of 1200 mg/day (400 mg TID) for 6 weeks
1218179|NCT00232596|O3|Outcome|Retigabine - DB Phase (Titration and Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of the Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of the Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
1218242|NCT00232544|P1|Participant Flow|TLC-CPAP|A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)
1218180|NCT00232596|O2|Outcome|Placebo (DB Phase) and Retigabine (Transition Phase)|Participants on placebo during the DB phase were administered retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a total daily dose of 1200 mg/day (400 mg TID) for 6 weeks
1218181|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration and Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
1218182|NCT00232596|O2|Outcome|Retigabine DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
1218255|NCT00232180|B2|Baseline|Placebo|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
1218183|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
1218184|NCT00232596|O2|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
1218185|NCT00232596|O1|Outcome|Placebo - Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks
1218186|NCT00232596|O2|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
1218187|NCT00232596|O1|Outcome|Placebo - Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks
1218188|NCT00232596|O2|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
1218189|NCT00232596|O1|Outcome|Placebo - Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks
1218190|NCT00232596|O2|Outcome|Retigabine DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
1218191|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
1218192|NCT00232596|O2|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
1218193|NCT00232596|O1|Outcome|Placebo - Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks
1218194|NCT00232596|O2|Outcome|Retigabine DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
1218195|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
1218196|NCT00232596|O2|Outcome|Retigabine DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
1218197|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
1218198|NCT00232596|O2|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
1218199|NCT00232596|O1|Outcome|Placebo - Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks
1218200|NCT00232596|O2|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
1218201|NCT00232596|O1|Outcome|Placebo - Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks
1218202|NCT00232596|O2|Outcome|Retigabine DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
1218203|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
1218243|NCT00232544|O2|Outcome|TLC-Control|A TLC system for providing general health education
1218244|NCT00232544|O1|Outcome|TLC-CPAP|A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)
1218245|NCT00232544|O2|Outcome|TLC-Control|A TLC system for providing general health education
1218204|NCT00232596|O2|Outcome|Retigabine DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
1218205|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
1218206|NCT00232596|O2|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID), for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
1218208|NCT00232596|O2|Outcome|Retigabine - DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
1218209|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
1218210|NCT00232596|O2|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
1218211|NCT00232596|O1|Outcome|Placebo - Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks
1218212|NCT00232596|O2|Outcome|Retigabine - DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
1218213|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
1218214|NCT00232596|E4|Reported Event|Retigabine (DB Phase) and Retigabine (Transition Phase)|Participants on retigabine during the DB phase were administered retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a total daily dose of 1200 mg/day (400 mg TID) for 6 weeks
1218215|NCT00232596|E3|Reported Event|Retigabine - DB Phase (Titration and Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of the Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of the Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
1218216|NCT00232596|E2|Reported Event|Placebo (DB Phase) and Retigabine (Transition Phase)|Participants on placebo during the DB phase were administered retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a total daily dose of 1200 mg/day (400 mg TID) for 6 weeks
1218217|NCT00232596|E1|Reported Event|Placebo - Double-blind (DB) Phase (Titration and Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
1218218|NCT00232583|B3|Baseline|Total|Total of all reporting groups
1218219|NCT00232583|B2|Baseline|Metfomin, Pioglitazone & Glyburide|
1218220|NCT00232583|B1|Baseline|Metfomin & Insulin|
1218221|NCT00232583|P2|Participant Flow|Metfomin, Pioglitazone & Glyburide|
1218222|NCT00232583|P1|Participant Flow|Metfomin & Insulin|
1218223|NCT00232583|O2|Outcome|Metformin, GLyburide & Pioglitazone|
1218224|NCT00232583|O1|Outcome|Metformin & Insulin|
1218225|NCT00232583|E2|Reported Event|Metfomin, Pioglitazone & Glyburide|
1218226|NCT00232583|E1|Reported Event|Metfomin & Insulin|
1218227|NCT00232557|B3|Baseline|Total|Total of all reporting groups
1218228|NCT00232557|B2|Baseline|TLC-health Education|A TLC system for providing general health education
1218229|NCT00232557|B1|Baseline|TLC-Asthma|A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens
1218230|NCT00232557|P2|Participant Flow|TLC-health Education|A TLC system for providing general health education
1218231|NCT00232557|P1|Participant Flow|TLC-Asthma|A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens
1218232|NCT00232557|O2|Outcome|TLC-health Education|A TLC system for providing general health education
1218233|NCT00232557|O1|Outcome|TLC-Asthma|A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens
1218234|NCT00232557|O2|Outcome|TLC-health Education|A TLC system for providing general health education
1218235|NCT00232557|O1|Outcome|TLC-Asthma|A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens
1218236|NCT00232557|E2|Reported Event|Arm 2|A TLC system for providing general health education
1218237|NCT00232557|E1|Reported Event|Arm 1|A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens
1218238|NCT00232544|B3|Baseline|Total|Total of all reporting groups
1218239|NCT00232544|B2|Baseline|TLC-Control|A TLC system for providing general health education
1218240|NCT00232544|B1|Baseline|TLC-CPAP|A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)
1218241|NCT00232544|P2|Participant Flow|TLC-Control|A TLC system for providing general health education
1218910|NCT00227903|O1|Outcome|Brief Advice|Advice and education
1218246|NCT00232544|O1|Outcome|TLC-CPAP|A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)
1218247|NCT00232544|E2|Reported Event|TLC-Control|A TLC system for providing general health education
1218248|NCT00232544|E1|Reported Event|TLC-CPAP|A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)
1218249|NCT00232479|B1|Baseline|Group 1|treat with taxotere, herceptin, carboplatin in dose dense fashion
1218250|NCT00232479|P1|Participant Flow|Group 1|study group receives taxotere, herceptin and carboplatin in dose dense fashion
1218251|NCT00232479|O1|Outcome|Group 1|patients received herceptin, carboplatin and taxotere in a dose dense fashion.
1218252|NCT00232479|O1|Outcome|Group 1|patients received dose dense herceptin, carboplatin and taxotere
1218253|NCT00232479|E1|Reported Event|Group 1|patients received herceptin, carboplatin, taxotere in dose dense fashion
1218254|NCT00232180|B3|Baseline|Total|Total of all reporting groups
1218256|NCT00232180|B1|Baseline|Eplerenone|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
1218257|NCT00232180|P3|Participant Flow|Eplerenone: Open Label Phase|Participants from double blind phase received eplerenone 25 mg tablet orally once daily on top of standard heart failure therapy for 12 months. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an eGFR between 30 to 49 ml/min/1.73m^2 in the double blind phase, initial dose was 25 mg orally once every other day; at Week 4, dose might had been increased to a maximum of 25 mg once daily based on serum potassium level.
1218258|NCT00232180|P2|Participant Flow|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
1218259|NCT00232180|P1|Participant Flow|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
1218260|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
1218261|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
1218262|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
1218263|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
1218264|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
1218265|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
1218266|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
1218267|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
1218268|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
1218269|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
1218270|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
1218271|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
1218272|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
1218494|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1218273|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
1218274|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
1218275|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
1218276|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
1218277|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
1218278|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
1218279|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
1218280|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
1218281|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
1218282|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
1218283|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
1218284|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
1218285|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
1218286|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
1218287|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
1218288|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
1218289|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
1218290|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
1218291|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
1218292|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
1218293|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
1218495|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1218294|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
1218295|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
1218296|NCT00232180|E5|Reported Event|Eplerenone: Open Label Phase|Participants from double blind phase received eplerenone 25 mg tablet orally once daily on top of standard heart failure therapy for 12 months. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an eGFR between 30 to 49 ml/min/1.73m^2 in the double blind phase, initial dose was 25 mg orally once every other day; at Week 4, dose might had been increased to a maximum of 25 mg once daily based on serum potassium level.
1218297|NCT00232180|E4|Reported Event|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
1218298|NCT00232180|E3|Reported Event|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heartfailure therapy. Dose might have been increased at Week 4 to 50 mg once daily.For participants with an estimated glomerular filtration rate (eGFR) between 30 to49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initialdose was 25 mg orally once every other day; at Week 4, dose might have beenincreased to a maximum of 25 mg once daily based on serum potassium level.
1218299|NCT00232180|E2|Reported Event|Placebo: Double-blind Phase(May 25, 2010 Data Cutoff)|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
1218300|NCT00232180|E1|Reported Event|Eplerenone: Double-blind Phase (May 25, 2010 Data Cut-off)|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
1218301|NCT00232141|B3|Baseline|Total|Total of all reporting groups
1218302|NCT00232141|B2|Baseline|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218303|NCT00232141|B1|Baseline|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218304|NCT00232141|P2|Participant Flow|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218305|NCT00232141|P1|Participant Flow|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218306|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218307|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218308|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218309|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218310|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218311|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218312|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218313|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218314|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218315|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218496|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1218316|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218317|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218318|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218319|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218455|NCT00231153|B1|Baseline|Omiganan 1% Gel|
1218320|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218321|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218322|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218323|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218324|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218325|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218326|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218327|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218328|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218329|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218330|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218331|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218332|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218333|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218334|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218335|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218336|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218337|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218338|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218911|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
1218339|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218340|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218341|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218342|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218343|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218344|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218345|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218346|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218347|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218348|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218349|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218350|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218351|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218352|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218353|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218354|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218355|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218356|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218357|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218358|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218359|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218360|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218448|NCT00231179|O1|Outcome|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
1218361|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218362|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218363|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218364|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218365|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218366|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218367|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218368|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218369|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218370|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
1218371|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
1218372|NCT00231816|B3|Baseline|Total|Total of all reporting groups
1218373|NCT00231816|B2|Baseline|Nonconcomitant Group|Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4
1218374|NCT00231816|B1|Baseline|Concomitant Group|ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
1218375|NCT00231816|P2|Participant Flow|Nonconcomitant Group|Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4
1218376|NCT00231816|P1|Participant Flow|Concomitant Group|ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
1218377|NCT00231816|O2|Outcome|Nonconcomitant Group|Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4
1218378|NCT00231816|O1|Outcome|Concomitant Group|ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
1218379|NCT00231816|O2|Outcome|Nonconcomitant Group|Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4
1218380|NCT00231816|O1|Outcome|Concomitant Group|ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
1218381|NCT00231816|O2|Outcome|Nonconcomitant Group|Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4
1218382|NCT00231816|O1|Outcome|Concomitant Group|ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
1218383|NCT00231816|O1|Outcome|Concomitant Group|ZOSTAVAX™ 0.65 mL SC injection administered comcomitantly with 0.5 mL IM influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
1218384|NCT00231816|O2|Outcome|Nonconcomitant Group|Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4
1218385|NCT00231816|O1|Outcome|Concomitant Group|ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
1218386|NCT00231816|E2|Reported Event|Nonconcomitant Group|Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4
1218387|NCT00231816|E1|Reported Event|Concomitant Group|ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
1218388|NCT00231777|B3|Baseline|Total|Total of all reporting groups
1218497|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1218912|NCT00227903|O1|Outcome|Brief Advice|Advice and education
1218389|NCT00231777|B2|Baseline|Ondansetron IV 4 mg|"On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.~The formulation of MK0517 used in this study was a non polysorbate (PS80) formulation which was not further developed and is not available for use.~Data Reported is for all all participants who received active study therapy."
1218390|NCT00231777|B1|Baseline|MK0517 Intravenous (IV) 40 mg|"On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.~Data Reported is for all all participants who received active study therapy."
1218391|NCT00231777|P2|Participant Flow|Ondansetron IV 4 mg|On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
1218392|NCT00231777|P1|Participant Flow|MK0517 Intravenous (IV) 40 mg|On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.
1218393|NCT00231777|O2|Outcome|Ondansetron IV 4 mg|On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
1218394|NCT00231777|O1|Outcome|MK0517 Intravenous (IV) 40 mg|On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.
1218395|NCT00231777|O2|Outcome|Ondansetron IV 4 mg|On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
1218396|NCT00231777|O1|Outcome|MK0517 Intravenous (IV) 40 mg|On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.
1218397|NCT00231777|O2|Outcome|Ondansetron IV 4 mg|On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
1218398|NCT00231777|O1|Outcome|MK0517 Intravenous (IV) 40 mg|On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.
1218399|NCT00231777|O2|Outcome|Ondansetron IV 4 mg|On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
1218400|NCT00231777|O1|Outcome|MK0517 Intravenous (IV) 40 mg|On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.
1218401|NCT00231777|E2|Reported Event|Ondansetron IV 4 mg|On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
1218402|NCT00231777|E1|Reported Event|MK0517 Intravenous (IV) 40 mg|On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.
1218403|NCT00231478|B3|Baseline|Total|Total of all reporting groups
1218404|NCT00231478|B2|Baseline|Granisetron 40 ug/kg|Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
1218405|NCT00231478|B1|Baseline|Granisetron 20 ug/kg|Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
1218406|NCT00231478|P2|Participant Flow|Granisetron 40 ug/kg|Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
1218407|NCT00231478|P1|Participant Flow|Granisetron 20 ug/kg|Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
1218408|NCT00231478|O2|Outcome|Granisetron 40 ug/kg|Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
1218409|NCT00231478|O1|Outcome|Granisetron 20 ug/kg|Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
1218410|NCT00231478|O2|Outcome|Granisetron 40 ug/kg|Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
1218411|NCT00231478|O1|Outcome|Granisetron 20 ug/kg|Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
1218412|NCT00231478|O2|Outcome|Granisetron 40 ug/kg|Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
1218413|NCT00231478|O1|Outcome|Granisetron 20 ug/kg|Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
1218414|NCT00231478|O2|Outcome|Granisetron 40 ug/kg|Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
1218415|NCT00231478|O1|Outcome|Granisetron 20 ug/kg|Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
1218416|NCT00231478|E2|Reported Event|Granisetron 40 ug/kg|Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
1218417|NCT00231478|E1|Reported Event|Granisetron 20 ug/kg|Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
1218418|NCT00231465|B1|Baseline|Taxotere® (Docetaxel) + ZD1839 (IRESSA®)|"Patients will receive Taxotere at 75 mg/m2 given IV over 60 minutes on day 1 of a three week cycle.~ZD1839 will be administered orally at 250mg daily starting on day one, concurrently with the Taxotere.~ZD1839 : ZD1839 will be continued until progression, or until trial closure, whichever comes first.~docetaxel (Taxotere®) : Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued."
1218419|NCT00231465|P1|Participant Flow|Taxotere® (Docetaxel) + ZD1839 (IRESSA®)|Eligible patients were treated with docetaxel 75 mg/m2 every three weeks and gefitinib 250 mg orally daily. Docetaxel and ZD1839 (gefitinib) were given for two cycles beyond maximal response. Gefitinib was continued until disease progression. Co-morbidities and activities of daily living were assessed (IADL).
1218449|NCT00231179|O2|Outcome|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
1218498|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1219869|NCT00218634|O2|Outcome|ETAU|Enhanced Treatment as Usual
1218420|NCT00231465|O1|Outcome|Taxotere® (Docetaxel) + ZD1839 (IRESSA®)|"Patients will receive Taxotere at 75 mg/m2 given IV over 60 minutes on day 1 of a three week cycle.~ZD1839 will be administered orally at 250mg daily starting on day one, concurrently with the Taxotere.~ZD1839 : ZD1839 will be continued until progression, or until trial closure, whichever comes first.~docetaxel (Taxotere®) : Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued."
1218421|NCT00231465|O1|Outcome|Taxotere® (Docetaxel) + ZD1839 (IRESSA®)|"Patients will receive Taxotere at 75 mg/m2 given IV over 60 minutes on day 1 of a three week cycle.~ZD1839 will be administered orally at 250mg daily starting on day one, concurrently with the Taxotere.~ZD1839 : ZD1839 will be continued until progression, or until trial closure, whichever comes first.~docetaxel (Taxotere®) : Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued."
1218508|NCT00231062|E1|Reported Event|Balloon Dilation of Sinus Ostia|
1218509|NCT00230971|B3|Baseline|Total|Total of all reporting groups
1218422|NCT00231465|O1|Outcome|Taxotere® (Docetaxel) + ZD1839 (IRESSA®)|"Patients will receive Taxotere at 75 mg/m2 given IV over 60 minutes on day 1 of a three week cycle.~ZD1839 will be administered orally at 250mg daily starting on day one, concurrently with the Taxotere.~ZD1839 : ZD1839 will be continued until progression, or until trial closure, whichever comes first.~docetaxel (Taxotere®) : Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued."
1218423|NCT00231465|E1|Reported Event|Taxotere® (Docetaxel) + ZD1839 (IRESSA®)|"Patients will receive Taxotere at 75 mg/m2 given IV over 60 minutes on day 1 of a three week cycle.~ZD1839 will be administered orally at 250mg daily starting on day one, concurrently with the Taxotere.~ZD1839 : ZD1839 will be continued until progression, or until trial closure, whichever comes first.~docetaxel (Taxotere®) : Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued."
1218424|NCT00231309|B1|Baseline|Single Arm|Granulocyte Colony Stimulating Factor : Granulocyte Colony Stimulating Factor
1218425|NCT00231309|P1|Participant Flow|Granulocyte Colony Stimulating Factor|Granulocyte Colony Stimulating Factor : Granulocyte Colony Stimulating Factor
1218426|NCT00231309|O1|Outcome|Granulocyte Colony Stimulating Factor|Granulocyte Colony Stimulating Factor : Granulocyte Colony Stimulating Factor
1218427|NCT00231309|O1|Outcome|Granulocyte-stimulating Factor|Granulocyte Colony Stimulating Factor : Granulocyte Colony Stimulating Factor
1218428|NCT00231309|E1|Reported Event|Single Arm|Granulocyte Colony Stimulating Factor : Granulocyte Colony Stimulating Factor
1218429|NCT00231283|B1|Baseline|CYPHER NxT Stent on the BX SONIC OTW SDS|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
1218430|NCT00231283|P1|Participant Flow|CYPHER NxT Stent on the BX SONIC OTW SDS|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
1218431|NCT00231283|O1|Outcome|CYPHER NxT Stent on the BX SONIC OTW SDS|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
1218432|NCT00231283|O1|Outcome|CYPHER NxT Stent on the BX SONIC OTW SDS|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
1218433|NCT00231283|O1|Outcome|CYPHER NxT Stent on the BX SONIC OTW SDS|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
1218434|NCT00231283|O1|Outcome|CYPHER NxT Stent on the BX SONIC OTW SDS|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
1218435|NCT00231283|E1|Reported Event|CYPHER NxT Stent on the BX SONIC OTW SDS|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
1218436|NCT00231179|B3|Baseline|Total|Total of all reporting groups
1218437|NCT00231179|B2|Baseline|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
1218438|NCT00231179|B1|Baseline|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
1218439|NCT00231179|P2|Participant Flow|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
1218440|NCT00231179|P1|Participant Flow|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
1218441|NCT00231179|O2|Outcome|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
1218442|NCT00231179|O1|Outcome|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
1218443|NCT00231179|O2|Outcome|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
1218444|NCT00231179|O1|Outcome|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
1218445|NCT00231179|O2|Outcome|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
1218446|NCT00231179|O1|Outcome|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
1218447|NCT00231179|O2|Outcome|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
1218493|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1218546|NCT00230737|O1|Outcome|A: Low Dose|Melatonin 0.4 mg
1218450|NCT00231179|O1|Outcome|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
1218451|NCT00231179|E2|Reported Event|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
1218452|NCT00231179|E1|Reported Event|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
1218453|NCT00231153|B3|Baseline|Total|Total of all reporting groups
1218454|NCT00231153|B2|Baseline|Povidone-Iodine|
1218456|NCT00231153|P2|Participant Flow|Povidone-Iodine|"All treated patients: Properly consented patients who received 1 or more doses of Povidone-Iodine with any post baseline observations (Primary Safety Population).~Modified Intent to Treat Subset: all ITT patients who did not have a BSI at randomization (baseline BSI) as determined by EC adjudication. Patients classified as 'present' (i.e. failure) or 'indeterminate' for baseline BSI were excluded from the MITT population. Patients missing baseline BSI status from EC adjudication were excluded from the MITT population. MITT Among Survivors: patients from the MITT population who did not die on study or who died and were positive (indeterminate or failure)for the study endpoint being analyzed prior to death (as determined by EC adjudication)."
1218457|NCT00231153|P1|Participant Flow|Omiganan 1% Gel|"All treated patients: Properly consented patients who received 1 or more doses of omiganan 1% gel with any post baseline observations (Primary Safety Population).~Modified Intent to Treat Subset: all ITT patients who did not have a BSI at randomization (baseline BSI) as determined by EC adjudication. Patients classified as 'present' (i.e. failure) or 'indeterminate' for baseline BSI were excluded from the MITT population. Patients missing baseline BSI status from EC adjudication were excluded from the MITT population. MITT Among Survivors: patients from the MITT population who did not die on study or who died and were positive (indeterminate or failure)for the study endpoint being analyzed prior to death (as determined by EC adjudication)."
1218458|NCT00231153|O2|Outcome|Povidone-Iodine|
1218459|NCT00231153|O1|Outcome|Omiganan 1% Gel|
1218460|NCT00231153|O2|Outcome|Povidone-Iodine|
1218461|NCT00231153|O1|Outcome|Omiganan 1% Gel|
1218462|NCT00231153|O2|Outcome|Povidone-Iodine|
1218463|NCT00231153|O1|Outcome|Omiganan 1% Gel|
1218464|NCT00231114|B3|Baseline|Total|Total of all reporting groups
1218465|NCT00231114|B2|Baseline|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1218466|NCT00231114|B1|Baseline|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1218467|NCT00231114|P2|Participant Flow|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1218468|NCT00231114|P1|Participant Flow|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1218469|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1218470|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1218471|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1218472|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1218473|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1218474|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1218475|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1218476|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1218477|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1218478|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1218479|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1218480|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1218481|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1218482|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1218483|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1218484|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1218485|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1218486|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1218487|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1218488|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1218489|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1218490|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1218491|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1218492|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
1218547|NCT00230737|E3|Reported Event|C: Control|Placebo
1218499|NCT00231114|E4|Reported Event|Sham (Post-Treatment Period)|Six weeks after the last bronchoscopy session until 12 Months. Sham treatment.
1218500|NCT00231114|E3|Reported Event|Alair (Post-Treatment Period)|Six weeks after the last bronchoscopy session until 12 Months. Airways treated with the Alair System.
1218501|NCT00231114|E2|Reported Event|Sham (Treatment Period)|Day of first bronchoscopy session until 6 weeks after the last bronchoscopy session. Sham treatment.
1218502|NCT00231114|E1|Reported Event|Alair (Treatment Period)|Day of first bronchoscopy session until 6 weeks after the last bronchoscopy session. Airways treated with the Alair System.
1218503|NCT00231062|B1|Baseline|Balloon Dilation of Sinus Ostia|
1218504|NCT00231062|P1|Participant Flow|Balloon Dilation of Sinus Ostia|
1218505|NCT00231062|O1|Outcome|Balloon Dilation of Sinus Ostia|
1218506|NCT00231062|O1|Outcome|Balloon Dilation of Sinus Ostia|
1218507|NCT00231062|O1|Outcome|Balloon Dilation of Sinus Ostia|
1218510|NCT00230971|B2|Baseline|Ceftriaxone|Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.
1218511|NCT00230971|B1|Baseline|Tigecycline|Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
1218512|NCT00230971|P2|Participant Flow|Ceftriaxone|Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.
1218513|NCT00230971|P1|Participant Flow|Tigecycline|Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
1218514|NCT00230971|O2|Outcome|Ceftriaxone|Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.
1218515|NCT00230971|O1|Outcome|Tigecycline|Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
1218516|NCT00230971|O2|Outcome|Ceftriaxone|Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.
1218517|NCT00230971|O1|Outcome|Tigecycline|Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
1218518|NCT00230971|O2|Outcome|Ceftriaxone|Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.
1218519|NCT00230971|O1|Outcome|Tigecycline|Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
1218520|NCT00230971|O2|Outcome|Ceftriaxone|Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.
1218521|NCT00230971|O1|Outcome|Tigecycline|Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
1218522|NCT00230971|E2|Reported Event|Ceftriaxone|Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.
1218523|NCT00230971|E1|Reported Event|Tigecycline|Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
1218524|NCT00230802|B3|Baseline|Total|Total of all reporting groups
1218525|NCT00230802|B2|Baseline|3 Tablet Increase|Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
1218526|NCT00230802|B1|Baseline|2 Tablet Increase|Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)
1218527|NCT00230802|P2|Participant Flow|3 Tablet Increase|Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
1218528|NCT00230802|P1|Participant Flow|2 Tablet Increase|Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)
1218529|NCT00230802|O2|Outcome|3 Tablet Increase|"Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).~Anticipatory dose increase of levothyroxine: as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.~levothyroxine: patients will increase levothyroxine by 3 extra tablets of their current dose per week."
1218530|NCT00230802|O1|Outcome|2 Tablet Increase|"Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)~Anticipatory dose increase of levothyroxine: as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.~levothyroxine: patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week"
1218531|NCT00230802|O2|Outcome|3 Tablet Increase|"Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).~Anticipatory dose increase of levothyroxine: as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.~levothyroxine: patients will increase levothyroxine by 3 extra tablets of their current dose per week."
1218532|NCT00230802|O1|Outcome|2 Tablet Increase|"Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)~Anticipatory dose increase of levothyroxine: as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.~levothyroxine: patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week"
1218533|NCT00230802|O2|Outcome|3 Tablet Increase|Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
1218534|NCT00230802|O1|Outcome|2 Tablet Increase|Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)
1218535|NCT00230802|E2|Reported Event|3 Tablet Increase|Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
1218536|NCT00230802|E1|Reported Event|2 Tablet Increase|Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)
1218537|NCT00230737|B4|Baseline|Total|Total of all reporting groups
1218538|NCT00230737|B3|Baseline|C: Control|Placebo
1218539|NCT00230737|B2|Baseline|B: High Dose|Melatonin 4.0 mg
1218540|NCT00230737|B1|Baseline|A: Low Dose|Melatonin 0.4 mg
1218541|NCT00230737|P3|Participant Flow|C: Control|Placebo
1218542|NCT00230737|P2|Participant Flow|B: High Dose|Melatonin 4.0 mg
1218543|NCT00230737|P1|Participant Flow|A: Low Dose|Melatonin 0.4 mg
1218544|NCT00230737|O3|Outcome|C: Control|Placebo
1218545|NCT00230737|O2|Outcome|B: High Dose|Melatonin 4.0 mg
1218550|NCT00230282|B1|Baseline|Fludarabine and Cyclophosphamide, Followed by Alemtuzumab|Fludarabine 25 mg/m2/d IV and cyclophosphamide 250 mg/m2/d SC on days 1 to 3 for each of six 28-day cycles, when the assessment for Primary Completion occurred. Responders entered a no-treatment rest period (observation) for 3 to 8 weeks, then depending on status, continued on follow-up or on-study to receive alemtuzumab IV starting at 3 mg/day with the dose adjusted to the maximum tolerated dose (up to 30 mg).
1218551|NCT00230282|P1|Participant Flow|Fludarabine and Cyclophosphamide, Followed by Alemtuzumab|Fludarabine 25 mg/m2/d IV and cyclophosphamide 250 mg/m2/d SC on days 1 to 3 for each of six 28-day cycles, when the assessment for Primary Completion occurred. Responders entered a no-treatment rest period (observation) for 3 to 8 weeks, then depending on status, continued on follow-up or on-study to receive alemtuzumab IV starting at 3 mg/day with the dose adjusted to the maximum tolerated dose (up to 30 mg).
1218719|NCT00229723|O6|Outcome|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
1218720|NCT00229723|O5|Outcome|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
1218552|NCT00230282|O1|Outcome|Fludarabine and Cyclophosphamide, Followed by Alemtuzumab|Fludarabine 25 mg/m2/d IV and cyclophosphamide 250 mg/m2/d SC on days 1 to 3 for each of six 28-day cycles, when the assessment for Primary Completion occurred. Responders entered a no-treatment rest period (observation) for 3 to 8 weeks, then depending on status, continued on follow-up or on-study to receive alemtuzumab IV starting at 3 mg/day with the dose adjusted to the maximum tolerated dose (up to 30 mg).
1218553|NCT00230282|O1|Outcome|Fludarabine and Cyclophosphamide, Followed by Alemtuzumab|Fludarabine 25 mg/m2/d IV and cyclophosphamide 250 mg/m2/d SC on days 1 to 3 for each of six 28-day cycles, when the assessment for Primary Completion occurred. Responders entered a no-treatment rest period (observation) for 3 to 8 weeks, then depending on status, continued on follow-up or on-study to receive alemtuzumab IV starting at 3 mg/day with the dose adjusted to the maximum tolerated dose (up to 30 mg).
1218554|NCT00230282|E1|Reported Event|Fludarabine, Cytoxan, Then Alemtuzumab|"Fludarabine and cyclophosphamide days 1 to 3 for six 28-day cycles. Minimal residual disease positive responders continued on-treatment to receive alemtuzumab 30 mg weekly. MRD negative responders were observed.~Alemtuzumab: 3 to 30 mg, IV~Fludarabine: [(2R,3R,4S,5R)-5-(6-amino-2-fluoro-purin-9-yl)- 3,4-dihydroxy-oxolan-2-yl]methoxyphosphonic acid~Cytoxan: (RS)-N,N-bis(2-chloroethyl)-1,3,2-oxazaphosphinan-2-amine 2-oxide"
1218555|NCT00228813|B1|Baseline|Granulocyte Colony Stimulating Factor (G-CSF) Stimulation|Participants with hematologic malignancies or bone marrow failure syndrome received in vivo T-cell depleted granulocyte colony stimulating factor (G-CSF) stimulated bone marrow from a partially mismatched related donor.
1218556|NCT00228813|P1|Participant Flow|Granulocyte Colony Stimulating Factor (G-CSF) Stimulation|Participants with hematologic malignancies or bone marrow failure syndrome received in vivo T-cell depleted granulocyte colony stimulating factor (G-CSF) stimulated bone marrow from a partially mismatched related donor.
1218557|NCT00228813|O1|Outcome|Granulocyte Colony Stimulating Factor (G-CSF) Stimulation|Participants received bone marrow from donors who underwent Granulocyte Colony Stimulating Factor (G-CSF) stimulation prior to bone marrow collection.
1218558|NCT00228813|O1|Outcome|Granulocyte Colony Stimulating Factor (G-CSF) Stimulation|Participants received bone marrow from donors who underwent Granulocyte Colony Stimulating Factor (G-CSF) stimulation prior to bone marrow collection.
1218559|NCT00228813|O1|Outcome|Granulocyte Colony Stimulating Factor (G-CSF) Stimulation|Participants received bone marrow from donors who underwent Granulocyte Colony Stimulating Factor (G-CSF) stimulation prior to bone marrow collection.
1218560|NCT00228813|E1|Reported Event|Granulocyte Colony Stimulating Factor (G-CSF) Stimulation|Participants with hematologic malignancies or bone marrow failure syndrome received in vivo T-cell depleted granulocyte colony stimulating factor (G-CSF) stimulated bone marrow from a partially mismatched related donor.
1218561|NCT00230178|B4|Baseline|Total|Total of all reporting groups
1218562|NCT00230178|B3|Baseline|Allopurinol|Allopurinol (300 mg/day) given alone as a single agent for 5 days
1218563|NCT00230178|B2|Baseline|Rasburicase + Allopurinol|Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)
1218564|NCT00230178|B1|Baseline|Rasburicase|Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days
1218565|NCT00230178|P3|Participant Flow|Allopurinol|Allopurinol (300 mg/day) given alone as a single agent for 5 days
1218566|NCT00230178|P2|Participant Flow|Rasburicase + Allopurinol|Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)
1218567|NCT00230178|P1|Participant Flow|Rasburicase|Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days
1218568|NCT00230178|O3|Outcome|Allopurinol|Allopurinol (300 mg/day) given alone as a single agent for 5 days
1218569|NCT00230178|O2|Outcome|Rasburicase + Allopurinol|Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)
1218570|NCT00230178|O1|Outcome|Rasburicase|Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days
1218571|NCT00230178|O3|Outcome|Allopurinol|Allopurinol (300 mg/day) given alone as a single agent for 5 days
1218572|NCT00230178|O2|Outcome|Rasburicase + Allopurinol|Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)
1218573|NCT00230178|O1|Outcome|Rasburicase|Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days
1218574|NCT00230178|O3|Outcome|Allopurinol|Allopurinol (300 mg/day) given alone as a single agent for 5 days
1218575|NCT00230178|O2|Outcome|Rasburicase + Allopurinol|Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)
1218576|NCT00230178|O1|Outcome|Rasburicase|Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days
1218577|NCT00230178|E3|Reported Event|Allopurinol|Allopurinol (300 mg/day) given alone as a single agent for 5 days
1218578|NCT00230178|E2|Reported Event|Rasburicase + Allopurinol|Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)
1218579|NCT00230178|E1|Reported Event|Rasburicase|Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days
1218580|NCT00230126|B3|Baseline|Total|Total of all reporting groups
1218913|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
1218581|NCT00230126|B2|Baseline|Arm B: Cycle 1 - 150-200 mg/Day Depending on Body Weight|"Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to generate skin rash.~Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
1218582|NCT00230126|B1|Baseline|Arm A: 150 mg/Day|"150 mg/day~erlotinib: Arm A: 150 mg/day Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
1218721|NCT00229723|O4|Outcome|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
1218930|NCT00227903|O1|Outcome|Brief Advice|Advice and education
1218583|NCT00230126|P2|Participant Flow|Arm B: Erlotinib 150 to 200 mg/Day Depending on Body Weight; C|"Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to generate skin rash.~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
1218584|NCT00230126|P1|Participant Flow|Arm A: Erlotinib 150 mg/Day|"150 mg/day cycles 1 - 3~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
1218585|NCT00230126|O2|Outcome|B Erlotinib Cycle 1 Dose Modified According to Weight|"erlotinib Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to skin rash.~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
1218586|NCT00230126|O1|Outcome|A Erlotinib 150 mg/Day Cycles 1 - 3|"erlotinib 150 mg/day cycles 1 - 3~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
1218587|NCT00230126|O2|Outcome|B Erlotinib Cycle 1 Dose Modified According to Weight|"erlotinib Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to skin rash.~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
1218588|NCT00230126|O1|Outcome|A Erlotinib 150 mg/Day Cycles 1 - 3|"erlotinib 150 mg/day cycles 1 - 3~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
1218589|NCT00230126|O2|Outcome|Arm B: Cycle 1 - 175 or 200 mg/Day Depending on Body Weight; C|"Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to generate skin rash.~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
1218590|NCT00230126|O1|Outcome|Erlotinib: Arm A: 150 mg/Day Cycles 1 - 3.|"150 mg/day cycles 1 - 3~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
1218591|NCT00230126|E2|Reported Event|Arm B: Cycle 1 - 175 or 200 mg/Day Depending on Body Weight; C|"Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to generate skin rash.~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
1218592|NCT00230126|E1|Reported Event|Arm A: 150 mg/Day Cycles 1 - 3|"150 mg/day cycles 1 - 3~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
1218593|NCT00230100|B3|Baseline|Total|Total of all reporting groups
1218594|NCT00230100|B2|Baseline|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
1218595|NCT00230100|B1|Baseline|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
1218596|NCT00230100|P2|Participant Flow|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
1218668|NCT00229957|B1|Baseline|Intervention Group|A rehabilitation multi-component intervention delivered by a physiotherapist and occupational therapist in a primary care setting included collaborative goal setting for rehabilitation needs, a six-week chronic disease self-management workshop, referral to community programs and a web-based education programme.
1218914|NCT00227903|O1|Outcome|Brief Advice|Advice and education
1218606|NCT00230100|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
1218597|NCT00230100|P1|Participant Flow|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
1218598|NCT00230100|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
1218599|NCT00230100|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
1218600|NCT00230100|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
1218601|NCT00230100|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
1218602|NCT00230100|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
1218603|NCT00230100|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
1218604|NCT00230100|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
1218605|NCT00230100|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
1218669|NCT00229957|P2|Participant Flow|Control Group|Usual care from the primary health care team which did not include physiotherapy or occupational therapy.
1218714|NCT00229723|O4|Outcome|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
1220196|NCT00217022|O2|Outcome|Placebo|three tablets daily
1218607|NCT00230100|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
1218608|NCT00230100|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
1218609|NCT00230100|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
1218610|NCT00230100|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
1218611|NCT00230100|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
1218612|NCT00230100|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
1218613|NCT00230100|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
1218614|NCT00230100|E2|Reported Event|Mixed-gender Group Drug Counseling|The GDC is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance dependence; 3) increase patients’ self-awareness of the problems that substance dependence has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse.
1218670|NCT00229957|P1|Participant Flow|Intervention Group|A rehabilitation multi-component intervention delivered by a physiotherapist and occupational therapist in a primary care setting included collaborative goal setting for rehabilitation needs, a six-week chronic disease self-management workshop, referral to community programs and a web-based education programme.
1218671|NCT00229957|O2|Outcome|Control Group|Usual care from the primary health care team which did not include physiotherapy or occupational therapy.
1218715|NCT00229723|O3|Outcome|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
1220197|NCT00217022|O1|Outcome|Budesonide|9 mg daily
1218672|NCT00229957|O1|Outcome|Intervention Group|A rehabilitation multi-component intervention delivered by a physiotherapist and occupational therapist in a primary care setting included collaborative goal setting for rehabilitation needs, a six-week chronic disease self-management workshop, referral to community programs and a web-based education programme.
1218673|NCT00229957|E2|Reported Event|Control Group|Usual care from the primary health care team which did not include physiotherapy or occupational therapy.
1218864|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
1218615|NCT00230100|E1|Reported Event|Women's Recovery Group|The WRG is a manual-based group therapy for women heterogeneous with respect to their substance dependence, co-occurring psychiatric disorders, trauma history, and age and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (b) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (c) help participants with skills and strategies useful in preventing relapse and promote recovery.
1218616|NCT00230048|B3|Baseline|Total|Total of all reporting groups
1218617|NCT00230048|B2|Baseline|Brief Intervention|Brief computer-delivered intervention following 5As/5Rs approach.
1218618|NCT00230048|B1|Baseline|Assessment Only|This arm answered questions only, but received no intervention.
1218619|NCT00230048|P2|Participant Flow|Brief Intervention|Brief computer-delivered intervention following motivational approach, adapted from Motivational Interviewing: Decisional balance, normed feedback, and optional goal-setting.
1218620|NCT00230048|P1|Participant Flow|Assessment Only|This arm answered questions only, but received no intervention.
1218621|NCT00230048|O2|Outcome|Brief Intervention|Brief computer-delivered intervention following 5As/5Rs approach.
1218622|NCT00230048|O1|Outcome|Assessment Only|This arm answered questions only, but received no intervention.
1218623|NCT00230048|O2|Outcome|Brief Intervention|Assessment plus 20-minute interactive session with computer, designed to be maximally similar to a therapist-delivered motivational session.
1218624|NCT00230048|O1|Outcome|Assessment Only|Assessment only, via computer.
1218625|NCT00230048|E2|Reported Event|Brief Intervention|Brief computer-delivered intervention following 5As/5Rs approach.
1218626|NCT00230048|E1|Reported Event|Assessment Only|This arm answered questions only, but received no intervention.
1218627|NCT00230022|B3|Baseline|Total|Total of all reporting groups
1218628|NCT00230022|B2|Baseline|Assessment Only|Only assessment, same as completed by intervention group. No further interaction with computer.
1218629|NCT00230022|B1|Baseline|Brief Computer-delivered Motivational Intervention|Brief computer-delivered intervention in three components: decisional balance, feedback, and optional goal setting.
1218630|NCT00230022|P2|Participant Flow|Assessment Only|Only assessment, same as completed by intervention group. No further interaction with computer.
1218631|NCT00230022|P1|Participant Flow|Brief Computer-delivered Motivational Intervention|Brief computer-delivered intervention in three components: decisional balance, feedback, and optional goal setting.
1218632|NCT00230022|O2|Outcome|Assessment Only|Only assessment measures with no subsequent intervention.
1218633|NCT00230022|O1|Outcome|Brief Computer-delivered Motivational Intervention|A brief assessment, plus a brief (20-minute) motivational intervention delivered solely by computer. The software was synchronously interactive and followed a traditional motivational interviewing approach.
1218634|NCT00230022|E2|Reported Event|Assessment Only|Only assessment, same as completed by intervention group. No further interaction with computer.
1218635|NCT00230022|E1|Reported Event|Brief Computer-delivered Motivational Intervention|Brief computer-delivered intervention in three components: decisional balance, feedback, and optional goal setting.
1218636|NCT00230009|B3|Baseline|Total|Total of all reporting groups
1218637|NCT00230009|B2|Baseline|Brief Intervention Session|
1218638|NCT00230009|B1|Baseline|Assessment Only|
1218639|NCT00230009|P2|Participant Flow|Brief Intervention Session|Brief assessment using Audio Computer Assisted Self Interview (A-CASI) technology to obtain the data. Plus brief therapist-delivered motivational intervention, which was tied to the results of the A-CASI assessment (results from which were viewable immediately by the therapist).
1218640|NCT00230009|P1|Participant Flow|Assessment Only|Brief assessment using Audio Computer Assisted Self Interview (A-CASI) technology to obtain the data only.
1218641|NCT00230009|O2|Outcome|Brief Intervention Session|
1218642|NCT00230009|O1|Outcome|Assessment Only|
1218643|NCT00230009|O2|Outcome|Brief Intervention Session|
1218644|NCT00230009|O1|Outcome|Assessment Only|
1218645|NCT00230009|O2|Outcome|Brief Intervention Session|
1218646|NCT00230009|O1|Outcome|Assessment Only|
1218647|NCT00230009|O2|Outcome|Brief Intervention Session|
1218648|NCT00230009|O1|Outcome|Assessment Only|
1218649|NCT00230009|O2|Outcome|Brief Intervention Session|
1218650|NCT00230009|O1|Outcome|Assessment Only|
1218651|NCT00230009|E2|Reported Event|Brief Intervention Session|
1218652|NCT00230009|E1|Reported Event|Assessment Only|
1218653|NCT00229970|B4|Baseline|Total|Total of all reporting groups
1218654|NCT00229970|B3|Baseline|Placebo|Placebo Intravenous Administration
1218655|NCT00229970|B2|Baseline|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
1218656|NCT00229970|B1|Baseline|Montelukast 7 mg|Montelukast 7 mg Intravenous Administration
1218657|NCT00229970|P3|Participant Flow|Placebo|Placebo Intravenous Administration
1218658|NCT00229970|P2|Participant Flow|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
1218659|NCT00229970|P1|Participant Flow|Montelukast 7 mg|Montelukast 7 mg Intravenous Administration
1218660|NCT00229970|O3|Outcome|Placebo|Placebo Intravenous Administration
1218661|NCT00229970|O2|Outcome|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
1218662|NCT00229970|O1|Outcome|Montelukast 7 mg|Montelukast 7 mg Intravenous Administration
1218663|NCT00229970|E3|Reported Event|Placebo|Placebo Intravenous Administration
1218664|NCT00229970|E2|Reported Event|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
1218665|NCT00229970|E1|Reported Event|Montelukast 7 mg|Montelukast 7 mg Intravenous Administration
1218666|NCT00229957|B3|Baseline|Total|Total of all reporting groups
1218667|NCT00229957|B2|Baseline|Control Group|Usual care from the primary health care team which did not include physiotherapy or occupational therapy.
1218800|NCT00228943|O1|Outcome|Full Strength Acute Tryptophan Depletion|
1218674|NCT00229957|E1|Reported Event|Intervention Group|A rehabilitation multi-component intervention delivered by a physiotherapist and occupational therapist in a primary care setting included collaborative goal setting for rehabilitation needs, a six-week chronic disease self-management workshop, referral to community programs and a web-based education programme.
1218675|NCT00229723|B8|Baseline|Total|Total of all reporting groups
1218676|NCT00229723|B7|Baseline|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
1218677|NCT00229723|B6|Baseline|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
1218678|NCT00229723|B5|Baseline|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
1218679|NCT00229723|B4|Baseline|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
1218680|NCT00229723|B3|Baseline|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
1218681|NCT00229723|B2|Baseline|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
1218682|NCT00229723|B1|Baseline|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
1218683|NCT00229723|P7|Participant Flow|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
1218684|NCT00229723|P6|Participant Flow|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
1218685|NCT00229723|P5|Participant Flow|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
1218686|NCT00229723|P4|Participant Flow|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
1218687|NCT00229723|P3|Participant Flow|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
1218688|NCT00229723|P2|Participant Flow|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
1218689|NCT00229723|P1|Participant Flow|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
1218690|NCT00229723|O7|Outcome|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
1218691|NCT00229723|O6|Outcome|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
1218692|NCT00229723|O5|Outcome|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
1218693|NCT00229723|O4|Outcome|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
1218694|NCT00229723|O3|Outcome|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
1218695|NCT00229723|O2|Outcome|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
1218696|NCT00229723|O1|Outcome|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
1218697|NCT00229723|O7|Outcome|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
1218698|NCT00229723|O6|Outcome|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
1218699|NCT00229723|O5|Outcome|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
1218700|NCT00229723|O4|Outcome|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
1218701|NCT00229723|O3|Outcome|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
1218702|NCT00229723|O2|Outcome|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
1218703|NCT00229723|O1|Outcome|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
1218704|NCT00229723|O7|Outcome|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
1218705|NCT00229723|O6|Outcome|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
1218706|NCT00229723|O5|Outcome|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
1218707|NCT00229723|O4|Outcome|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
1218708|NCT00229723|O3|Outcome|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
1218709|NCT00229723|O2|Outcome|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
1218710|NCT00229723|O1|Outcome|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
1218711|NCT00229723|O7|Outcome|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
1218712|NCT00229723|O6|Outcome|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
1218713|NCT00229723|O5|Outcome|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
1218801|NCT00228943|O2|Outcome|Half-Strength Tryptophan Depletion - Control|
1218716|NCT00229723|O2|Outcome|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
1218717|NCT00229723|O1|Outcome|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
1218718|NCT00229723|O7|Outcome|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
1218722|NCT00229723|O3|Outcome|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
1218723|NCT00229723|O2|Outcome|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
1218724|NCT00229723|O1|Outcome|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
1218725|NCT00229723|O7|Outcome|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
1218726|NCT00229723|O6|Outcome|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
1218727|NCT00229723|O5|Outcome|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
1218728|NCT00229723|O4|Outcome|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
1218729|NCT00229723|O3|Outcome|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
1218730|NCT00229723|O2|Outcome|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
1218731|NCT00229723|O1|Outcome|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
1218732|NCT00229723|E7|Reported Event|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
1218733|NCT00229723|E6|Reported Event|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
1218734|NCT00229723|E5|Reported Event|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
1218735|NCT00229723|E4|Reported Event|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
1218736|NCT00229723|E3|Reported Event|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
1218737|NCT00229723|E2|Reported Event|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
1218738|NCT00229723|E1|Reported Event|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
1218739|NCT00229658|B3|Baseline|Total|Total of all reporting groups
1218740|NCT00229658|B2|Baseline|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
1218741|NCT00229658|B1|Baseline|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
1218742|NCT00229658|P2|Participant Flow|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
1218743|NCT00229658|P1|Participant Flow|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
1218744|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
1218745|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
1218746|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
1218747|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
1218748|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
1218749|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
1218750|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
1218751|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
1218752|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
1218753|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
1218754|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
1218755|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
1218756|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
1218757|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
1218758|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
1218759|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
1218760|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
1218761|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
1218762|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
1218763|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
1218764|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
1218765|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
1218766|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
1218767|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
1218768|NCT00229658|E2|Reported Event|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
1218769|NCT00229658|E1|Reported Event|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
1218802|NCT00228943|O1|Outcome|Full Strength Acute Tryptophan Depletion|
1218803|NCT00228943|E2|Reported Event|Half-Strength Tryptophan Depletion - Control|No adverse events
1220198|NCT00217022|O2|Outcome|Placebo|three tablets daily
1218770|NCT00229619|B1|Baseline|Rituximab Subjects|Rituximab will be given to moderate aplastic anemia (MAA), pure red cell aplasia or Diamond Blackfan anemia subjects. Rituxmiab will be given to evaluate if these bone marrow failure syndrome subjects will have an immune response to the intervention. The subjects will receive 375 mg/ meters squared of rituximab which will be infused intravenously once evey week for a total of 4 doses.
1218771|NCT00229619|P1|Participant Flow|Rituximab Treated Subjects|Rituximab will be given to moderate aplastic anemia (MAA), pure red cell aplasia or Diamond Blackfan anemia subjects. Rituxmiab will be given to evaluate if these bone marrow failure syndrome subjects will have an immune response to the intervention. The subjects will receive 375 mg/ meters squared of rituximab which will be infused intravenously once evey week for a total of 4 doses.
1218931|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
1218772|NCT00229619|O1|Outcome|Rituximab Subjects|Rituximab will be given to moderate aplastic anemia (MAA), pure red cell aplasia or Diamond Blackfan anemia subjects. Rituxmiab will be given to evaluate if these bone marrow failure syndrome subjects will have an immune response to the intervention. The subjects will receive 375 mg/ meters squared of rituximab which will be infused intravenously once evey week for a total of 4 doses.
1218773|NCT00229619|E1|Reported Event|Rituximab Subjects|Rituximab will be given to moderate aplastic anemia (MAA), pure red cell aplasia or Diamond Blackfan anemia subjects. Rituxmiab will be given to evaluate if these bone marrow failure syndrome subjects will have an immune response to the intervention. The subjects will receive 375 mg/ meters squared of rituximab which will be infused intravenously once evey week for a total of 4 doses.
1218774|NCT00228566|B1|Baseline|Armodafinil 150 to 250 mg/Day|Armodafinil 150 to 250 mg once daily in the morning
1218775|NCT00228566|P1|Participant Flow|Armodafinil 150 to 250 mg/Day|Armodafinil 150 to 250 mg once daily in the morning
1218776|NCT00228566|O1|Outcome|Armodafinil 150 to 250 mg/Day|Armodafinil 150 to 250 mg once daily in the morning
1218777|NCT00228566|E1|Reported Event|Armodafinil 150 to 250 mg/Day|Armodafinil 150 to 250 mg once daily in the morning
1218778|NCT00228553|B1|Baseline|Armodafinil 100 to 250 mg/Day|Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD)
1218779|NCT00228553|P1|Participant Flow|Armodafinil 100 to 250 mg/Day|Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD)
1218780|NCT00228553|O1|Outcome|Armodafinil 100 to 250 mg/Day|Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD)
1218781|NCT00228553|E1|Reported Event|Armodafinil 100 to 250 mg/Day|Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD)
1218782|NCT00229203|B3|Baseline|Total|Total of all reporting groups
1218783|NCT00229203|B2|Baseline|Plitidepsin + Dexamethasone|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
1218784|NCT00229203|B1|Baseline|Plitidepsin|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
1218785|NCT00229203|P2|Participant Flow|Plitidepsin + Dexamethasone|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
1218786|NCT00229203|P1|Participant Flow|Plitidepsin|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
1218787|NCT00229203|O2|Outcome|Plitidepsin + Dexamethasone|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
1218788|NCT00229203|O1|Outcome|Plitidepsin|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
1218789|NCT00229203|O2|Outcome|Plitidepsin + Dexamethasone|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
1218790|NCT00229203|O1|Outcome|Plitidepsin|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
1218791|NCT00229203|O2|Outcome|Plitidepsin + Dexamethasone|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
1218792|NCT00229203|O1|Outcome|Plitidepsin|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
1218793|NCT00229203|O2|Outcome|Plitidepsin + Dexamethasone|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
1218794|NCT00229203|O1|Outcome|Plitidepsin|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
1218795|NCT00229203|E2|Reported Event|Plitidepsin + Dexamethasone|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
1218796|NCT00229203|E1|Reported Event|Plitidepsin|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
1218797|NCT00228943|B1|Baseline|Entire Sample|"Consented subjects in the entire sample were randomized to one of two groups for the cross-over design study. One group of subjects received a full-strength tryptophan depletion drink during week 1 followed by a half-strength (control) drink week 2. The other group of subjects received a half-strength tryptophan depletion (control) drink during week 1 followed by a full-strength drink week 2.~The final analysis combined groups to compare full strength versus control."
1218798|NCT00228943|P1|Participant Flow|Full Strength Acute Tryptophan Depletion and Control|Subjects were randomized to receive both a full-strength acute tryptophan depletion drink and half-strength tryptophan depletion drink (control). Some participants received the full-strength drink first for week 1 and then crossed-over to the half-strength (control) drink for week 2; the other participants received the half-strength (control) drink for week 1 and then crossed over to the full-strength drink for week 2.
1218799|NCT00228943|O2|Outcome|Half-Strength Tryptophan Depletion - Control|
1218806|NCT00228917|B4|Baseline|TRITANRIX-HEPB+Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1218865|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
1218866|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
1218807|NCT00228917|B3|Baseline|TRITANRIX-HEPB/ HIBERIX +Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1218808|NCT00228917|B2|Baseline|Trianrix-Hepb/Mencevax+Trianrix-HepB/Hiberix GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1218809|NCT00228917|B1|Baseline|Trianrix-Hepb/Hib-MenAC-TT GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm.
1218810|NCT00228917|P4|Participant Flow|TRITANRIX-HEPB+Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/ NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1218811|NCT00228917|P3|Participant Flow|TRITANRIX-HEPB/ HIBERIX +Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/ NCT00317187) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1218812|NCT00228917|P2|Participant Flow|Trianrix-Hepb/Mencevax+Trianrix-HepB/Hiberix GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135/ NCT00317187) were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1218813|NCT00228917|P1|Participant Flow|Trianrix-Hepb/Hib-MenAC-TT GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135/ NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm.
1218814|NCT00228917|O4|Outcome|TRITANRIX-HEPB+Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1218815|NCT00228917|O3|Outcome|TRITANRIX-HEPB/ HIBERIX +Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1218816|NCT00228917|O2|Outcome|Trianrix-Hepb/Mencevax+Trianrix-HepB/Hiberix GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1218817|NCT00228917|O1|Outcome|Trianrix-Hepb/Hib-MenAC-TT GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm.
1218818|NCT00228917|O4|Outcome|TRITANRIX-HEPB+Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1218915|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
1218819|NCT00228917|O3|Outcome|TRITANRIX-HEPB/ HIBERIX +Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1218820|NCT00228917|O2|Outcome|Trianrix-Hepb/Mencevax+Trianrix-HepB/Hiberix GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1218821|NCT00228917|O1|Outcome|Trianrix-Hepb/Hib-MenAC-TT GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm.
1218822|NCT00228917|O4|Outcome|TRITANRIX-HEPB+Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1218823|NCT00228917|O3|Outcome|TRITANRIX-HEPB/ HIBERIX +Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1218824|NCT00228917|O2|Outcome|Trianrix-Hepb/Mencevax+Trianrix-HepB/Hiberix GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1218825|NCT00228917|O1|Outcome|Trianrix-Hepb/Hib-MenAC-TT GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm.
1218826|NCT00228917|O4|Outcome|TRITANRIX-HEPB+Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1218827|NCT00228917|O3|Outcome|TRITANRIX-HEPB/ HIBERIX +Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1218828|NCT00228917|O2|Outcome|Trianrix-Hepb/Mencevax+Trianrix-HepB/Hiberix GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1218829|NCT00228917|O1|Outcome|Trianrix-Hepb/Hib-MenAC-TT GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm.
1218830|NCT00228917|O4|Outcome|TRITANRIX-HEPB+Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1218831|NCT00228917|O3|Outcome|TRITANRIX-HEPB/ HIBERIX +Mencevax GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1218916|NCT00227903|O1|Outcome|Brief Advice|Advice and education
1218832|NCT00228917|O2|Outcome|Trianrix-Hepb/Mencevax+Trianrix-HepB/Hiberix GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1218833|NCT00228917|O1|Outcome|Trianrix-Hepb/Hib-MenAC-TT GROUP|Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135/NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm.
1218834|NCT00228917|E4|Reported Event|TRITANRIX-HEPB/ TRITANRIX-HEPB GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135 or NCT00317187 for the NCT00228917 study and NCT00317161 for the NCT00136604 study) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Tritanrix™-HepB/Hiberix™ vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1218835|NCT00228917|E3|Reported Event|TRITANRIX-HEPB/ HIBERIX GROUP|Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135 or NCT00317187 for the NCT00228917 study and NCT00317161 for the NCT00136604 study) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1218836|NCT00228917|E2|Reported Event|HIBERIX/TRITANRIX-HEPB GROUP|Subjects vaccinated with 3 doses of Mencevax™ ACW vaccine in the primary study (NCT00317135 or NCT00317187 for the NCT00228917 study and NCT00317161 for the NCT00136604 study) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Tritanrix™-HepB/Hiberix™ vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1218837|NCT00228917|E1|Reported Event|HIBERIX/ HIBERIX GROUP|Subjects vaccinated with 3 doses of Mencevax™ ACW vaccine in the primary study (NCT00317135 or NCT00317187 for the NCT00228917 study and NCT00317161 for the NCT00136604 study) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACW vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
1218838|NCT00228384|B3|Baseline|Total|Total of all reporting groups
1218839|NCT00228384|B2|Baseline|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
1218840|NCT00228384|B1|Baseline|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
1218841|NCT00228384|P2|Participant Flow|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
1218842|NCT00228384|P1|Participant Flow|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
1218843|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
1218844|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
1218845|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
1218846|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
1218847|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
1218848|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
1218849|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
1218850|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
1218851|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
1218852|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
1218853|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
1218854|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
1218855|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
1218856|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
1218857|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
1218858|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
1218859|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
1218860|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
1218917|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
1218861|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
1218862|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
1218863|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
1218928|NCT00227903|O1|Outcome|Brief Advice|Advice and education
1218867|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
1218868|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
1218869|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
1218870|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
1218871|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
1218872|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
1218873|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
1218874|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
1218875|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
1218876|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
1218877|NCT00228384|E2|Reported Event|Bare Nitinol Stent|Bare Nitinol Stent
1218878|NCT00228384|E1|Reported Event|GORE VIABAHN Endoprosthesis|GORE VIABAHN Endoprosthesis
1218879|NCT00227994|B3|Baseline|Total|Total of all reporting groups
1218880|NCT00227994|B2|Baseline|Donepezil|"Donepezil for 12 weeks~Donepezil: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks."
1218881|NCT00227994|B1|Baseline|Galantamine|"Galantamine for 12 weeks~Galantamine: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study."
1218882|NCT00227994|P2|Participant Flow|Donepezil|"Donepezil for 12 weeks~Donepezil: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks."
1218883|NCT00227994|P1|Participant Flow|Galantamine|"Galantamine for 12 weeks~Galantamine: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study."
1218884|NCT00227994|O2|Outcome|Donepezil|"Donepezil for 12 weeks~Donepezil: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks."
1218885|NCT00227994|O1|Outcome|Galantamine|"Galantamine for 12 weeks~Galantamine: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study."
1218886|NCT00227994|O2|Outcome|Donepezil|"Donepezil for 12 weeks~Donepezil: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks."
1218887|NCT00227994|O1|Outcome|Galantamine|"Galantamine for 12 weeks~Galantamine: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study."
1218888|NCT00227994|E2|Reported Event|Donepezil|"Donepezil for 12 weeks~Donepezil: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks."
1218889|NCT00227994|E1|Reported Event|Galantamine|"Galantamine for 12 weeks~Galantamine: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study."
1218890|NCT00227903|B3|Baseline|Total|Total of all reporting groups
1218891|NCT00227903|B2|Baseline|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
1218892|NCT00227903|B1|Baseline|Brief Advice|Advice and education
1218893|NCT00227903|P2|Participant Flow|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
1218894|NCT00227903|P1|Participant Flow|Brief Advice|Advice and education
1218895|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
1218896|NCT00227903|O1|Outcome|Brief Advice|Advice and education
1218897|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
1218898|NCT00227903|O1|Outcome|Brief Advice|Advice and education
1218899|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
1218900|NCT00227903|O1|Outcome|Brief Advice|Advice and education
1218901|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
1218902|NCT00227903|O1|Outcome|Brief Advice|Advice and education
1218903|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
1218904|NCT00227903|O1|Outcome|Brief Advice|Advice and education
1218905|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
1218906|NCT00227903|O1|Outcome|Brief Advice|Advice and education
1218907|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
1218908|NCT00227903|O1|Outcome|Brief Advice|Advice and education
1218909|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
1218919|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
1218920|NCT00227903|O1|Outcome|Brief Advice|Advice and education
1218921|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
1218922|NCT00227903|O1|Outcome|Brief Advice|Advice and education
1218923|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
1218924|NCT00227903|O1|Outcome|Brief Advice|Advice and education
1218925|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
1218926|NCT00227903|O1|Outcome|Brief Advice|Advice and education
1218927|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
1218933|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
1218934|NCT00227903|O1|Outcome|Brief Advice|Advice and education
1218935|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
1218936|NCT00227903|O1|Outcome|Brief Advice|Advice and education
1218937|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
1218938|NCT00227903|O1|Outcome|Brief Advice|Advice and education
1218939|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
1218940|NCT00227903|O1|Outcome|Brief Advice|Advice and education
1218941|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
1218942|NCT00227903|O1|Outcome|Brief Advice|Advice and education
1218943|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
1218944|NCT00227903|O1|Outcome|Brief Advice|Advice and education
1218945|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
1218946|NCT00227903|O1|Outcome|Brief Advice|Advice and education
1218947|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
1218948|NCT00227903|O1|Outcome|Brief Advice|Advice and education
1218949|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
1218950|NCT00227903|O1|Outcome|Brief Advice|Advice and education
1218951|NCT00227903|E2|Reported Event|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
1218952|NCT00227903|E1|Reported Event|Brief Advice|Advice and education
1218953|NCT00227760|B1|Baseline|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cediranib Maleate: Given PO~Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
1218954|NCT00227760|P1|Participant Flow|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cediranib Maleate: Given PO~Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
1218955|NCT00227760|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cediranib Maleate: Given PO~Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
1218956|NCT00227760|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cediranib Maleate: Given PO~Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
1218957|NCT00227760|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cediranib Maleate: Given PO~Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
1218958|NCT00227760|E1|Reported Event|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cediranib Maleate: Given PO~Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
1218959|NCT00227721|B1|Baseline|Docetaxel & Gemcitabine Hydrochloride|"Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle~Docetaxel: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days~Gemcitabine hydrochloride: 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days"
1218960|NCT00227721|P1|Participant Flow|Docetaxel & Gemcitabine Hydrochloride|"Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle~Docetaxel: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days~Gemcitabine hydrochloride: 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days"
1218961|NCT00227721|O1|Outcome|Docetaxel & Gemcitabine Hydrochloride|"Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle~Docetaxel: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days~Gemcitabine hydrochloride: 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days"
1218962|NCT00227721|E1|Reported Event|Docetaxel & Gemcitabine Hydrochloride|"Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle~Docetaxel: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days~Gemcitabine hydrochloride: 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days"
1218963|NCT00227591|B1|Baseline|Lenalidomide|Lenalidomide 10 mg/day plus prednisone X 28 days X 3 cycles
1218964|NCT00227591|P1|Participant Flow|Lenalidomide|Lenalidomide 10 mg/day plus prednisone X 28 days X 3 cycles
1218965|NCT00227591|O1|Outcome|Lenalidomide|Lenalidomide 10 mg/day plus prednisone X 28 days X 3 cycles
1218966|NCT00227591|E1|Reported Event|Lenalidomide|Lenalidomide 10 mg/day plus prednisone X 28 days X 3 cycles
1218967|NCT00227539|B1|Baseline|Neoadjuvant Therapy, PET Scan and Surgery|"cisplatin~pemetrexed disodium~adjuvant therapy~therapeutic conventional surgery~fludeoxyglucose F 18"
1218968|NCT00227539|P1|Participant Flow|Neoadjuvant Therapy, PET Scan and Surgery|"cisplatin~pemetrexed disodium~adjuvant therapy~therapeutic conventional surgery~fludeoxyglucose F 18"
1218969|NCT00227539|O1|Outcome|Neoadjuvant Therapy, PET Scan and Surgery|"cisplatin~pemetrexed disodium~adjuvant therapy~therapeutic conventional surgery~fludeoxyglucose F 18"
1218970|NCT00227539|O1|Outcome|Neoadjuvant Therapy, PET Scan and Surgery|"cisplatin~pemetrexed disodium~adjuvant therapy~therapeutic conventional surgery~fludeoxyglucose F 18"
1219017|NCT00227305|B1|Baseline|Quetiapine|Quetiapine 400mg/day to 800mg/day
1218971|NCT00227539|O1|Outcome|Neoadjuvant Therapy, PET Scan and Surgery|"cisplatin~pemetrexed disodium~adjuvant therapy~therapeutic conventional surgery~fludeoxyglucose F 18"
1218972|NCT00227539|E1|Reported Event|Neoadjuvant Therapy, PET Scan and Surgery|"cisplatin~pemetrexed disodium~adjuvant therapy~therapeutic conventional surgery~fludeoxyglucose F 18"
1218973|NCT00227370|B3|Baseline|Total|Total of all reporting groups
1218974|NCT00227370|B2|Baseline|Treatment Group|Upon randomisation at 3 months, patients remained on Valganciclovir for 9 additional months.
1218975|NCT00227370|B1|Baseline|Placebo Group|Upon randomisation at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis
1218976|NCT00227370|P2|Participant Flow|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
1218977|NCT00227370|P1|Participant Flow|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis). 3 months of Valganciclovir was the standard of care for CMV prevention at the time of study initiation. This was the prespecified placebo group/intervention arm.
1218978|NCT00227370|O2|Outcome|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
1218979|NCT00227370|O1|Outcome|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
1218980|NCT00227370|O2|Outcome|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
1218981|NCT00227370|O1|Outcome|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
1218982|NCT00227370|O2|Outcome|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
1218983|NCT00227370|O1|Outcome|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
1218984|NCT00227370|O2|Outcome|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
1218985|NCT00227370|O1|Outcome|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
1218986|NCT00227370|O2|Outcome|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
1218987|NCT00227370|O1|Outcome|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
1218988|NCT00227370|O2|Outcome|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
1218989|NCT00227370|O1|Outcome|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
1218990|NCT00227370|O2|Outcome|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
1218991|NCT00227370|O1|Outcome|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
1218992|NCT00227370|E2|Reported Event|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
1218993|NCT00227370|E1|Reported Event|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
1218994|NCT00227344|B3|Baseline|Total|Total of all reporting groups
1218995|NCT00227344|B2|Baseline|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
1218996|NCT00227344|B1|Baseline|Catheter Ablation|Catheter Ablation
1218997|NCT00227344|P2|Participant Flow|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
1218998|NCT00227344|P1|Participant Flow|Catheter Ablation|Catheter Ablation
1218999|NCT00227344|O2|Outcome|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
1219000|NCT00227344|O1|Outcome|Catheter Ablation|Catheter Ablation
1219001|NCT00227344|O2|Outcome|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
1219002|NCT00227344|O1|Outcome|Catheter Ablation|Catheter Ablation
1219003|NCT00227344|O2|Outcome|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
1219004|NCT00227344|O1|Outcome|Catheter Ablation|Catheter Ablation
1219005|NCT00227344|O2|Outcome|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
1219006|NCT00227344|O1|Outcome|Catheter Ablation|Catheter Ablation
1219395|NCT00224042|P1|Participant Flow|Ferrlecit|Sodium ferric gluconate complex in sucrose injection
1219007|NCT00227344|O2|Outcome|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
1219008|NCT00227344|O1|Outcome|Catheter Ablation|Catheter Ablation
1219009|NCT00227344|O2|Outcome|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
1219010|NCT00227344|O1|Outcome|Catheter Ablation|Catheter Ablation
1219011|NCT00227344|O2|Outcome|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
1219012|NCT00227344|O1|Outcome|Catheter Ablation|Catheter Ablation
1219013|NCT00227344|O2|Outcome|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
1219014|NCT00227344|O1|Outcome|Catheter Ablation|Catheter Ablation
1219015|NCT00227344|E2|Reported Event|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
1219018|NCT00227305|P1|Participant Flow|Quetiapine|Quetiapine 400mg/day to 800mg/day
1219019|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
1219020|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
1219021|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
1219022|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
1219023|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
1219024|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
1219025|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
1219026|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
1219027|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
1219028|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
1219029|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
1219030|NCT00227305|E1|Reported Event|Quetiapine|Quetiapine 400mg/day to 800mg/day
1219031|NCT00227266|B4|Baseline|Total|Total of all reporting groups
1219032|NCT00227266|B3|Baseline|Cohort 2 Standers and Walkers - Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
1219033|NCT00227266|B2|Baseline|Cohort 1b Sitters Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
1219034|NCT00227266|B1|Baseline|Cohort 1a Sitters Placebo Then Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor or equivalent placebo in the liquid form.
1219035|NCT00227266|P3|Participant Flow|Cohort 2 Standers and Walkers - Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
1219036|NCT00227266|P2|Participant Flow|Cohort 1b Sitters Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
1219037|NCT00227266|P1|Participant Flow|Cohort 1a Sitters Placebo Then Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor or equivalent placebo in the liquid form.
1219038|NCT00227266|O3|Outcome|Cohort 2 Standers and Walkers - Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
1219039|NCT00227266|O2|Outcome|Cohort 1b Sitters Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
1219040|NCT00227266|O1|Outcome|Cohort 1a Sitters Placebo Then Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor or equivalent placebo in the liquid form.
1219059|NCT00227019|O1|Outcome|Bevacizumab + Pemetrexed|Treatment group is adult patients with metastatic non squamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.
1219041|NCT00227266|O3|Outcome|Cohort 2 Standers and Walkers - Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
1219042|NCT00227266|O2|Outcome|Cohort 1b Sitters Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
1219157|NCT00225251|O1|Outcome|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day~bupropion XL: Antidepressant medication"
1219158|NCT00225251|E2|Reported Event|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
1219412|NCT00224016|B1|Baseline|Oxybutynin TDS|Oxybutynin Transdermal System
1219043|NCT00227266|O1|Outcome|Cohort 1a Sitters Placebo Then Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor or equivalent placebo in the liquid form.
1219044|NCT00227266|O2|Outcome|Cohort 1b Sitters Treatment|
1219045|NCT00227266|O1|Outcome|Cohort 1a Sitters Placebo Then Treatment|
1219046|NCT00227266|O1|Outcome|Cohort 2 Experimental|"Patients in cohort 2 (SMA standers and walkers) will receive VPA + Carnitine treatment for the entire 12 month time period."
1219047|NCT00227266|O3|Outcome|Cohort 2 Standers and Walkers - Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
1219048|NCT00227266|O2|Outcome|Cohort 1b Sitters Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
1219049|NCT00227266|O1|Outcome|Cohort 1a Sitters Placebo Then Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor or equivalent placebo in the liquid form.
1219050|NCT00227266|O3|Outcome|Cohort 2 Standers and Walkers - Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
1219051|NCT00227266|O2|Outcome|Cohort 1b Sitters Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
1219052|NCT00227266|O1|Outcome|Cohort 1a Sitters Placebo Then Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor or equivalent placebo in the liquid form.
1219053|NCT00227266|E3|Reported Event|Cohort 2 Standers and Walkers - Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
1219054|NCT00227266|E2|Reported Event|Cohort 1b Sitters Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
1219055|NCT00227266|E1|Reported Event|Cohort 1a Sitters Placebo Then Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor or equivalent placebo in the liquid form.
1219056|NCT00227019|B1|Baseline|Bevacizumab Plus Pemetrexed|Treatment group is adult patients with metastatic nonsquamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.
1219057|NCT00227019|P1|Participant Flow|Bevacizumab Plus Pemetrexed|Treatment group is adult patients with metastatic nonsquamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.
1219058|NCT00227019|O1|Outcome|Bevacizumab + Pemetrexed|Treatment group is adult patients with metastatic nonsquamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.
1219156|NCT00225251|O2|Outcome|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
1219396|NCT00224042|O2|Outcome|Oral Iron|
1219060|NCT00227019|O1|Outcome|Bevacizumab + Pemetrexed|Treatment group is adult patients with metastatic non squamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.
1219061|NCT00227019|E1|Reported Event|Bevacizumab Plus Pemetrexed|Treatment group is adult patients with metastatic non squamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.
1219159|NCT00225251|E1|Reported Event|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day~bupropion XL: Antidepressant medication"
1219062|NCT00226811|B1|Baseline|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
1219063|NCT00226811|P1|Participant Flow|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
1219064|NCT00226811|O1|Outcome|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
1219065|NCT00226811|O1|Outcome|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
1219066|NCT00226811|O1|Outcome|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
1219067|NCT00226811|O1|Outcome|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
1219068|NCT00226811|O1|Outcome|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
1219069|NCT00226811|O1|Outcome|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
1219070|NCT00226811|O1|Outcome|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
1219071|NCT00226811|E1|Reported Event|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
1219072|NCT00226655|B1|Baseline|hCRF|All patients will receive hCRF (XERECEPT) 2mg/day
1219073|NCT00226655|P1|Participant Flow|hCRF|All patients will receive hCRF (XERECEPT) 2mg/day
1219074|NCT00226655|O1|Outcome|hCRF|hCRF administered 1mg bid subcutaneously
1219075|NCT00226655|E1|Reported Event|hCRF|All patients will receive hCRF (XERECEPT) 2mg/day
1219076|NCT00226590|B1|Baseline|Combination Therapy|In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.
1219077|NCT00226590|P1|Participant Flow|Combination Therapy|In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.
1219078|NCT00226590|O1|Outcome|Combination Therapy|In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.
1219079|NCT00226590|O1|Outcome|Combination Therapy|In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.
1219080|NCT00226590|O1|Outcome|Combination Therapy|In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.
1219081|NCT00226590|O1|Outcome|Induction Therapy|Tolerance of Induction Therapy prior to Chemoradiation
1219082|NCT00226590|E1|Reported Event|Combination Therapy|In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.
1220199|NCT00217022|O1|Outcome|Budesonide|9 mg daily
1219083|NCT00226577|B1|Baseline|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
1219160|NCT00225212|B1|Baseline|Rituximab After ASCT|Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT
1219084|NCT00226577|P1|Participant Flow|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
1219085|NCT00226577|O1|Outcome|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
1219086|NCT00226577|O1|Outcome|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
1219087|NCT00226577|O1|Outcome|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
1219088|NCT00226577|O1|Outcome|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
1219089|NCT00226577|O1|Outcome|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
1219090|NCT00226577|E1|Reported Event|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
1219091|NCT00225784|B1|Baseline|Cetuximab/Gemcitabine/Radiotherapy|weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy
1219092|NCT00225784|P1|Participant Flow|Cetuximab, Gemcitabine, Radiotherapy|Weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy
1219093|NCT00225784|O1|Outcome|Cetuximab, Gemcitabine, Radiotherapy|Weekly cetuximab twice-weekly gemcitabine plus intensity modulated radiotherapy.
1219094|NCT00225784|O1|Outcome|Cetuximab, Gemcitabine, Radiotherapy|Weekly cetuximab twice-weekly gemcitabine plus intensity modulated radiotherapy.
1219095|NCT00225784|O1|Outcome|Cetuximab, Gemcitabine, Radiotherapy|Weekly cetuximab twice-weekly gemcitabine plus intensity modulated radiotherapy.
1219096|NCT00225784|O2|Outcome|Cetuximab, Gemcitabine, Radiotherapy in EGFR (+) Tumors|Percentage of response to weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy in patients with EGFR positive tumors.
1219097|NCT00225784|O1|Outcome|Cetuximab, Gemcitabine, Radiotherapy in EGFR (-) Tumors|Percentage of response to weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy in patients with EGFR negative tumors.
1219098|NCT00225784|O1|Outcome|Cetuximab, Gemcitabine, Radiotherapy|Weekly cetuximab twice-weekly gemcitabine plus intensity modulated radiotherapy.
1219099|NCT00225784|O1|Outcome|Cetuximab, Gemcitabine, Radiotherapy|Weekly cetuximab twice-weekly gemcitabine plus intensity modulated radiotherapy.
1219100|NCT00225784|O1|Outcome|Cetuximab, Gemcitabine, Radiotherapy|Weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy.
1219101|NCT00225784|E1|Reported Event|Cetuximab/Gemcitabine/Radiotherapy|weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy
1219102|NCT00225732|B3|Baseline|Total|Total of all reporting groups
1219103|NCT00225732|B2|Baseline|800 mg Intravenous Ibuprofen|The first dose of intravenous ibuprofen will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous ibuprofen will be administered every 6 hours. After receiving 8 doses of intravenous ibuprofen, intravenous ibuprofen will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
1219104|NCT00225732|B1|Baseline|Placebo|The first dose of intravenous placebo will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous placebo will be administered every 6 hours. After receiving 8 doses of intravenous placebo, intravenous placebo will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
1219161|NCT00225212|P1|Participant Flow|Rituximab After ASCT|Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT
1219162|NCT00225212|O1|Outcome|Rituximab After ASCT|Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT
1219105|NCT00225732|P2|Participant Flow|800 mg Intravenous Ibuprofen|The first dose of intravenous ibuprofen will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous ibuprofen will be administered every 6 hours. After receiving 8 doses of intravenous ibuprofen, intravenous ibuprofen will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
1219106|NCT00225732|P1|Participant Flow|Placebo|The first dose of intravenous placebo will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous placebo will be administered every 6 hours. After receiving 8 doses of intravenous placebo, intravenous placebo will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
1219107|NCT00225732|O2|Outcome|800 mg Intravenous Ibuprofen|The first dose of intravenous ibuprofen will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous ibuprofen will be administered every 6 hours. After receiving 8 doses of intravenous ibuprofen, intravenous ibuprofen will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
1219108|NCT00225732|O1|Outcome|Placebo|The first dose of intravenous placebo will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous placebo will be administered every 6 hours. After receiving 8 doses of intravenous placebo, intravenous placebo will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
1219109|NCT00225732|E2|Reported Event|800 mg Intravenous Ibuprofen|The first dose of intravenous ibuprofen will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous ibuprofen will be administered every 6 hours. After receiving 8 doses of intravenous ibuprofen, intravenous ibuprofen will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
1219110|NCT00225732|E1|Reported Event|Placebo|The first dose of intravenous placebo will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous placebo will be administered every 6 hours. After receiving 8 doses of intravenous placebo, intravenous placebo will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
1219111|NCT00225498|B1|Baseline|All Participants|Baseline characteristics for all participants prior to randomization are reported because treatment assignment information is not available. That information was not preserved when the orginally planned analyses were not conducted because the enrollment was insufficient for statistically valid results.
1219112|NCT00225498|P1|Participant Flow|Ziprasidone|ziprasidone target dose is 160 mg/day
1219113|NCT00225498|O1|Outcome|Ziprasidone|ziprasidone target dose is 160 mg/day
1219114|NCT00225498|E1|Reported Event|Ziprasidone|
1219115|NCT00225420|B1|Baseline|Overall Study|"Single Arm Docetaxel: Docetaxel will be administered per the designated cohort starting at 10, 15 or 20 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.~leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.~radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments."
1219116|NCT00225420|P3|Participant Flow|Docetaxel 20 mg/m2|"Single Arm~docetaxel: Docetaxel will be administered per the designated cohort starting at 20 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.~leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg intramuscular (IM) and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.~radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments"
1219117|NCT00225420|P2|Participant Flow|Docetaxel 15 mg/m2|"Single Arm~docetaxel: Docetaxel will be administered per the designated cohort starting at 15 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.~leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg intramuscular (IM) and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.~radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments"
1219118|NCT00225420|P1|Participant Flow|Docetaxel 10 mg/m2|"Single Arm~docetaxel: Docetaxel will be administered per the designated cohort starting at 10 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.~leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg intramuscular (IM) and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.~radiation therapy: The total dose will be 7800 centigray (cGy) in 200 cGy per fraction for a total of 39 treatments."
1219119|NCT00225420|O1|Outcome|Single Arm|"Single Arm~docetaxel: Docetaxel will be administered per the designated cohort starting at 10 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.~leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.~radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments."
1219120|NCT00225420|O3|Outcome|Docetaxel 20 mg/m2|"Single Arm~docetaxel: Docetaxel will be administered per the designated cohort starting at 20 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.~leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.~radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments"
1219121|NCT00225420|O2|Outcome|Docetaxel 15 mg/m2|"Single Arm~docetaxel: Docetaxel will be administered per the designated cohort starting at 15 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.~leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.~radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments"
1219122|NCT00225420|O1|Outcome|Docetaxel at 10 mg/m2|"Single Arm~docetaxel: Docetaxel will be administered per the designated cohort starting at 10 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.~leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.~radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments."
1219123|NCT00225420|E1|Reported Event|Single Arm|"Single Arm~docetaxel: Docetaxel will be administered per the designated cohort starting at 10 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.~leuprolide acetate: Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.~radiation therapy: The total dose will be 7800 cGy in 200 cGy per fraction for a total of 39 treatments."
1219124|NCT00225277|B3|Baseline|Total|Total of all reporting groups
1219125|NCT00225277|B2|Baseline|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
1219126|NCT00225277|B1|Baseline|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
1219127|NCT00225277|P2|Participant Flow|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
1219128|NCT00225277|P1|Participant Flow|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
1219129|NCT00225277|O2|Outcome|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
1219130|NCT00225277|O1|Outcome|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
1219131|NCT00225277|O2|Outcome|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
1219132|NCT00225277|O1|Outcome|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
1219133|NCT00225277|O2|Outcome|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
1219134|NCT00225277|O1|Outcome|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
1219135|NCT00225277|O2|Outcome|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
1219136|NCT00225277|O1|Outcome|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
1219137|NCT00225277|O2|Outcome|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
1219138|NCT00225277|O1|Outcome|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
1219139|NCT00225277|O2|Outcome|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
1219140|NCT00225277|O1|Outcome|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
1219141|NCT00225277|E2|Reported Event|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
1219142|NCT00225277|E1|Reported Event|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
1219143|NCT00225251|B3|Baseline|Total|Total of all reporting groups
1219144|NCT00225251|B2|Baseline|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
1219145|NCT00225251|B1|Baseline|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day~bupropion XL: Antidepressant medication"
1219146|NCT00225251|P2|Participant Flow|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
1219147|NCT00225251|P1|Participant Flow|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day~bupropion XL: Antidepressant medication"
1219148|NCT00225251|O2|Outcome|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
1219149|NCT00225251|O1|Outcome|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day~bupropion XL: Antidepressant medication"
1219150|NCT00225251|O2|Outcome|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
1219151|NCT00225251|O1|Outcome|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day~bupropion XL: Antidepressant medication"
1219152|NCT00225251|O2|Outcome|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
1219153|NCT00225251|O1|Outcome|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day~bupropion XL: Antidepressant medication"
1219154|NCT00225251|O2|Outcome|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
1219155|NCT00225251|O1|Outcome|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day~bupropion XL: Antidepressant medication"
1219163|NCT00225212|O1|Outcome|Rituximab After ASCT|Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT
1219164|NCT00225212|E1|Reported Event|Rituximab After ASCT|Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT
1219165|NCT00225147|B5|Baseline|Total|Total of all reporting groups
1219166|NCT00225147|B4|Baseline|"50 IU/kg Open-label rhC1INH"|"Baseline characteristics were calculated for the modified intention to treat (mITT)analysis population, which included all subjects who received 50 IU/kg open-label rhC1INH."
1219167|NCT00225147|B3|Baseline|Placebo|"Baseline characteristics were calculated for the modified intention to treat (mITT) analysis population, which included all subjects randomized to the placebo arm."
1219168|NCT00225147|B2|Baseline|"50 IU/kg rhC1INH"|"Baseline characteristics were calculated for the modified intention to treat (mITT) and per protocol analysis populations, which included subjects who received 50 IU/kg rhC1INH. One (1) subject was randomized to the 50 IU/kg rhC1INH arm, but did not receive study drug administration and was excluded from the mITT analysis population."
1219169|NCT00225147|B1|Baseline|"100 IU/kg rhC1INH"|"Baseline characteristics were calculated for the modified intention to treat (mITT) and per protocol analysis populations, which included all subjects who received 100 IU/kg rhC1INH."
1219170|NCT00225147|P4|Participant Flow|"50 IU/kg Open-label rhC1INH"|"Includes all subjects treated with 50 IU/kg open-label rhC1INH in the open-label phase."
1219171|NCT00225147|P3|Participant Flow|Placebo|Includes all subjects randomized and treated with Placebo in the double-blind phase
1219172|NCT00225147|P2|Participant Flow|"50 IU/kg rhC1INH"|Includes all subjects randomized and treated with 50 IU/kg Recombinant human C1 inhibitor in the double-blind phase
1219173|NCT00225147|P1|Participant Flow|"100 IU/kg rhC1INH"|Includes all subjects randomized and treated with 100 IU/kg Recombinant human C1 inhibitor in the double-blind phase
1219174|NCT00225147|O4|Outcome|"50 IU/kg Open-label rhC1INH"|Includes all subjects who received 50 IU/kg open-label Recombinant human C1 inhibitor
1219175|NCT00225147|O3|Outcome|Placebo|Includes all subjects enrolled and randomized to the Saline arm
1219176|NCT00225147|O2|Outcome|"50 IU/kg rhC1INH"|Includes all subjects enrolled and randomized to the 50 IU/kg Recombinant human C1 inhibitor arm
1219177|NCT00225147|O1|Outcome|"100 IU/kg rhC1INH"|Includes all subjects enrolled and randomized to the 100 IU/kg Recombinant human C1 inhibitor arm
1219178|NCT00225147|O4|Outcome|"50 IU/kg Open-label rhC1INH"|Includes all subjects who received 50 IU/kg open-label Recombinant human C1 inhibitor
1219179|NCT00225147|O3|Outcome|Placebo|Includes all subjects enrolled and randomized to the Saline arm
1219180|NCT00225147|O2|Outcome|"50 IU/kg rhC1INH"|Includes all subjects enrolled and randomized to the 50 IU/kg body weight recombinant human C1 Inhibitor arm
1219181|NCT00225147|O1|Outcome|"100 IU/kg rhC1INH"|Includes all subjects enrolled and randomized to the 100 IU/kg body weight recombinant human C1 Inhibitor arm
1219182|NCT00225147|E4|Reported Event|"50 IU/kg Open-label rhC1INH"|"Includes all subjects receiving 50 IU/kg open-label recombinant human C1 inhibitor and subjects receiving an additional dose of 50 IU/kg rhC1INH within 4 hours after initial administration."
1219183|NCT00225147|E3|Reported Event|Placebo|Includes all subjects receiving Saline solution
1219184|NCT00225147|E2|Reported Event|50 IU/kg rhC1INH|Includes all subjects receiving 50 IU/kg Recombinant human C1 inhibitor
1219185|NCT00225147|E1|Reported Event|100 IU/kg rhC1INH|Includes all subjects receiving 100 IU/kg Recombinant human C1 inhibitor
1219186|NCT00225017|B3|Baseline|Total|Total of all reporting groups
1219187|NCT00225017|B2|Baseline|Control (Continue Protease Inhibitor)|ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
1219188|NCT00225017|B1|Baseline|Atazanavir Switch|"ARM A: Switch current PI to atazanavir 400 mg once daily plus current > 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.~Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily."
1219189|NCT00225017|P2|Participant Flow|Control (Continue Protease Inhibitor)|ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
1219190|NCT00225017|P1|Participant Flow|Atazanavir Switch|"ARM A: Switch current PI to atazanavir 400 mg once daily plus current > 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.~Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily."
1219191|NCT00225017|O2|Outcome|Control (Continue Protease Inhibitor)|ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
1219192|NCT00225017|O1|Outcome|Atazanavir Switch|"ARM A: Switch current PI to atazanavir 400 mg once daily plus current > 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.~Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily."
1219193|NCT00225017|O2|Outcome|Control (Continue Protease Inhibitor)|ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
1219194|NCT00225017|O1|Outcome|Atazanavir Switch|"ARM A: Switch current PI to atazanavir 400 mg once daily plus current > 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.~Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily."
1219195|NCT00225017|O2|Outcome|Control (Continue Protease Inhibitor)|ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
1219196|NCT00225017|O1|Outcome|Atazanavir Switch|"ARM A: Switch current PI to atazanavir 400 mg once daily plus current > 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.~Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily."
1219197|NCT00225017|E2|Reported Event|Control (Continue Protease Inhibitor)|ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
1219408|NCT00224029|O1|Outcome|Oxybutynin Transdermal System|
1219198|NCT00225017|E1|Reported Event|Atazanavir Switch|"ARM A: Switch current PI to atazanavir 400 mg once daily plus current > 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.~Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily."
1219199|NCT00224874|B5|Baseline|Total|Total of all reporting groups
1219200|NCT00224874|B4|Baseline|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
1219201|NCT00224874|B3|Baseline|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
1219202|NCT00224874|B2|Baseline|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
1219203|NCT00224874|B1|Baseline|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
1219204|NCT00224874|P4|Participant Flow|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
1219205|NCT00224874|P3|Participant Flow|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
1219206|NCT00224874|P2|Participant Flow|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
1219207|NCT00224874|P1|Participant Flow|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
1219208|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
1219209|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
1219210|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
1219211|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
1219212|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
1219213|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
1219214|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
1219215|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
1219216|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
1219217|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
1219218|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
1219219|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
1219220|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
1219221|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
1219222|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
1219223|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
1219224|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
1219225|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
1219226|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
1219227|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
1219228|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
1219229|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
1219230|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
1219231|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
1219232|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
1219233|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
1219234|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
1219235|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
1219236|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
1219237|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
1219238|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
1219239|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
1219240|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
1219241|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
1219242|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
1219243|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
1219244|NCT00224874|E4|Reported Event|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
1219245|NCT00224874|E3|Reported Event|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
1219246|NCT00224874|E2|Reported Event|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
1219247|NCT00224874|E1|Reported Event|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
1219248|NCT00224770|B4|Baseline|Total|Total of all reporting groups
1219249|NCT00224770|B3|Baseline|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
1219250|NCT00224770|B2|Baseline|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo®) through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
1219251|NCT00224770|B1|Baseline|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
1219252|NCT00224770|P3|Participant Flow|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
1219253|NCT00224770|P2|Participant Flow|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
1219254|NCT00224770|P1|Participant Flow|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
1219255|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
1219256|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
1219257|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
1219258|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
1219279|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
1220200|NCT00217022|E2|Reported Event|Placebo|three tablets daily
1219259|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
1219260|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
1219261|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
1219409|NCT00224029|E1|Reported Event|Oxybutynin Transdermal System|
1219262|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
1219263|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
1219264|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
1219265|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
1219266|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
1219267|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
1219268|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
1219269|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
1219270|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative targeting technique as the MISTIE arm. No rt-PA administered, and in addition to best medical care.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
1219271|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
1219272|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
1219273|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
1219274|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
1219275|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
1219276|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
1219277|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
1219278|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
1219280|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
1219281|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
1219282|NCT00224770|E3|Reported Event|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
1219283|NCT00224770|E2|Reported Event|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
1219284|NCT00224770|E1|Reported Event|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
1219285|NCT00224484|B4|Baseline|Total|Total of all reporting groups
1219286|NCT00224484|B3|Baseline|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219287|NCT00224484|B2|Baseline|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219288|NCT00224484|B1|Baseline|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219289|NCT00224484|P3|Participant Flow|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219290|NCT00224484|P2|Participant Flow|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219291|NCT00224484|P1|Participant Flow|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219292|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219293|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219294|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219295|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219296|NCT00224484|O2|Outcome|Pooled Group|Pooled group of subjects 10-17 years of age from Havrix and Saline groups.
1219297|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219298|NCT00224484|O2|Outcome|Pooled Group|Pooled group of subjects 10-17 years of age from Havrix and Saline groups.
1219299|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219300|NCT00224484|O2|Outcome|Pooled Group|Pooled group of subjects 10-17 years of age from Havrix and Saline groups.
1219301|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219302|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219303|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219304|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219305|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219306|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219307|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219390|NCT00224055|E1|Reported Event|IV Iron|
1219391|NCT00224042|B3|Baseline|Total|Total of all reporting groups
1219392|NCT00224042|B2|Baseline|Oral Iron|
1219308|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219309|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219310|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219311|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219410|NCT00224016|B3|Baseline|Total|Total of all reporting groups
1219312|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219313|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219314|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219315|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219316|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219317|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219318|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219319|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219320|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219321|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219322|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219323|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219324|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219325|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219326|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219327|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219328|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219329|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219330|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219331|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219332|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219333|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219334|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219335|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219336|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219393|NCT00224042|B1|Baseline|Ferrlecit|Sodium ferric gluconate complex in sucrose injection
1219337|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219338|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219339|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219340|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219341|NCT00224484|O3|Outcome|Saline Group|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219342|NCT00224484|O2|Outcome|Havrix Group|Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219343|NCT00224484|O1|Outcome|gD2-AS04 Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219344|NCT00224484|E5|Reported Event|Pooled Group|Pooled group of subjects 10-17 years of age from Havrix and Saline groups, included in the Extended Safety Follow Up (ESFU) period.
1219345|NCT00224484|E4|Reported Event|GD2-AS04 (ESFU) Group|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219346|NCT00224484|E3|Reported Event|Group Saline|Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219347|NCT00224484|E2|Reported Event|Group Havrix|Female subjects aged 10-17 years, who received 3 doses of Havrix™ vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219348|NCT00224484|E1|Reported Event|Group GD2-AS04|Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
1219349|NCT00224289|B1|Baseline|Topical Latanoprost|"All participants will be taking Latanoprost; This study compares efficacy within age groups.~Latanoprost 0.005% : Latanoprost 0.005% ophthalmic solution QHS 8 weeks"
1219350|NCT00224289|P1|Participant Flow|Topical Latanoprost|"All participants will be taking Latanoprost; This study compares efficacy within age groups.~Latanoprost 0.005% : Latanoprost 0.005% ophthalmic solution QHS 8 weeks"
1219351|NCT00224289|O1|Outcome|Topical Latanoprost|"All participants will be taking Latanoprost; This study compares efficacy within age groups.~Latanoprost 0.005% : Latanoprost 0.005% ophthalmic solution QHS 8 weeks"
1219352|NCT00224289|O1|Outcome|Topical Latanoprost|"All participants will be taking Latanoprost; This study compares efficacy within age groups.~Latanoprost 0.005% : Latanoprost 0.005% ophthalmic solution QHS 8 weeks"
1219353|NCT00224289|E1|Reported Event|Topical Latanoprost|"All participants will be taking Latanoprost; This study compares efficacy within age groups.~Latanoprost 0.005% : Latanoprost 0.005% ophthalmic solution QHS 8 weeks"
1219354|NCT00224133|B1|Baseline|8 mg Silodosin Per Day With Food|
1219355|NCT00224133|P1|Participant Flow|8 mg Silodosin Per Day With Food|
1219356|NCT00224133|O1|Outcome|8 mg Silodosin Per Day With Food|
1219357|NCT00224133|E1|Reported Event|8 mg Silodosin Per Day With Food|
1219358|NCT00224120|B3|Baseline|Total|Total of all reporting groups
1219359|NCT00224120|B2|Baseline|Placebo|Matching placebo capsule once daily with food
1219360|NCT00224120|B1|Baseline|Silodosin|Silodosin 8 mg once daily with food
1219361|NCT00224120|P2|Participant Flow|Placebo|Matching placebo capsule once daily with food
1219362|NCT00224120|P1|Participant Flow|Silodosin|Silodosin 8 mg once daily with food
1219363|NCT00224120|O2|Outcome|Placebo|Matching placebo capsule once daily with food
1219364|NCT00224120|O1|Outcome|Silodosin|Silodosin 8 mg once daily with food
1219365|NCT00224120|O2|Outcome|Placebo|Matching placebo capsule once daily with food
1219366|NCT00224120|O1|Outcome|Silodosin|Silodosin 8 mg once daily with food
1219367|NCT00224120|E2|Reported Event|Placebo|Matching placebo capsule once daily with food
1219368|NCT00224120|E1|Reported Event|Silodosin|Silodosin 8 mg once daily with food
1219369|NCT00224107|B3|Baseline|Total|Total of all reporting groups
1219370|NCT00224107|B2|Baseline|Placebo|Matching placebo capsule once daily with food
1219371|NCT00224107|B1|Baseline|Silodosin|Silodosin 8 mg once daily with food
1219372|NCT00224107|P2|Participant Flow|Placebo|Matching placebo capsule once daily with food
1219373|NCT00224107|P1|Participant Flow|Silodosin|Silodosin 8 mg once daily with food
1219374|NCT00224107|O2|Outcome|Placebo|Matching placebo capsule once daily with food
1219375|NCT00224107|O1|Outcome|Silodosin|Silodosin 8 mg once daily with food
1219376|NCT00224107|O2|Outcome|Placebo|Matching placebo capsule once daily with food
1219377|NCT00224107|O1|Outcome|Silodosin|Silodosin 8 mg once daily with food
1219378|NCT00224107|E2|Reported Event|Placebo|Matching placebo capsule once daily with food
1219379|NCT00224107|E1|Reported Event|Silodosin|Silodosin 8 mg once daily with food
1219380|NCT00224055|B3|Baseline|Total|Total of all reporting groups
1219381|NCT00224055|B2|Baseline|Oral Iron|
1219382|NCT00224055|B1|Baseline|IV Iron|
1219383|NCT00224055|P2|Participant Flow|Oral Iron|
1219384|NCT00224055|P1|Participant Flow|IV Iron|
1219385|NCT00224055|O2|Outcome|Oral Iron|
1219386|NCT00224055|O1|Outcome|IV Iron|
1219387|NCT00224055|O2|Outcome|Oral Iron|
1219388|NCT00224055|O1|Outcome|IV Iron|
1219389|NCT00224055|E2|Reported Event|Oral Iron|
1219397|NCT00224042|O1|Outcome|Ferrlecit|Sodium ferric gluconate complex in sucrose injection
1219398|NCT00224042|O2|Outcome|Oral Iron|
1219399|NCT00224042|O1|Outcome|Ferrlecit|Sodium ferric gluconate complex in sucrose injection
1219400|NCT00224042|O2|Outcome|Oral Iron|
1219401|NCT00224042|O1|Outcome|Ferrlecit|Sodium ferric gluconate complex in sucrose injection
1219402|NCT00224042|O2|Outcome|Oral Iron|
1219403|NCT00224042|O1|Outcome|Ferrlecit|Sodium ferric gluconate complex in sucrose injection
1219404|NCT00224042|E2|Reported Event|Oral Iron|
1219405|NCT00224042|E1|Reported Event|Ferrlecit|Sodium ferric gluconate complex in sucrose injection
1219406|NCT00224029|B1|Baseline|Oxybutynin Transdermal System|
1219407|NCT00224029|P1|Participant Flow|Oxybutynin Transdermal System|
1219414|NCT00224016|P1|Participant Flow|Oxybutynin TDS|Oxybutynin Transdermal System
1219415|NCT00224016|O2|Outcome|Oral Oxybutynin|Oxybutynin tablets
1219416|NCT00224016|O1|Outcome|Oxybutynin TDS|Oxybutynin Transdermal System
1219417|NCT00224016|O2|Outcome|Oral Oxybutynin|Oxybutynin tablets
1219418|NCT00224016|O1|Outcome|Oxybutynin TDS|Oxybutynin Transdermal System
1219419|NCT00224016|E2|Reported Event|Oral Oxybutynin|Oxybutynin tablets
1219420|NCT00224016|E1|Reported Event|Oxybutynin TDS|Oxybutynin Transdermal System
1219421|NCT00224003|B1|Baseline|Sodium Ferric Gluconate Complex|
1219422|NCT00224003|P1|Participant Flow|Sodium Ferric Gluconate Complex|
1219423|NCT00224003|O1|Outcome|Sodium Ferric Gluconate Complex|
1219424|NCT00224003|O1|Outcome|Sodium Ferric Gluconate Complex|
1219425|NCT00223977|B4|Baseline|Total|Total of all reporting groups
1219426|NCT00223977|B3|Baseline|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
1219427|NCT00223977|B2|Baseline|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
1219428|NCT00223977|B1|Baseline|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
1219429|NCT00223977|P3|Participant Flow|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
1219430|NCT00223977|P2|Participant Flow|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
1219431|NCT00223977|P1|Participant Flow|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
1219432|NCT00223977|O3|Outcome|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
1219433|NCT00223977|O2|Outcome|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
1219434|NCT00223977|O1|Outcome|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
1219435|NCT00223977|O3|Outcome|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
1219436|NCT00223977|O2|Outcome|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
1219437|NCT00223977|O1|Outcome|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
1219438|NCT00223977|O3|Outcome|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
1219439|NCT00223977|O2|Outcome|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
1219440|NCT00223977|O1|Outcome|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
1219441|NCT00223977|O3|Outcome|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
1219442|NCT00223977|O2|Outcome|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
1219443|NCT00223977|O1|Outcome|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
1219444|NCT00223977|O3|Outcome|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
1219445|NCT00223977|O2|Outcome|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
1219446|NCT00223977|O1|Outcome|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
1219447|NCT00223977|E3|Reported Event|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
1219448|NCT00223977|E2|Reported Event|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
1219449|NCT00223977|E1|Reported Event|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
1219450|NCT00223821|B3|Baseline|Total|Total of all reporting groups
1219451|NCT00223821|B2|Baseline|Arm 2|"drug therapy + behavioral training~Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.~Behavior Training : Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training."
1219452|NCT00223821|B1|Baseline|Arm 1|"drug therapy alone~Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects."
1219453|NCT00223821|P2|Participant Flow|Drug Therapy + Behavioral Training|"drug therapy + behavioral training~Oxybutynin chloride, extended-release: Individually-titrated, extended-release oxybutynin chloride with management of side-effects.~Behavior Training: Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training."
1219454|NCT00223821|P1|Participant Flow|Drug Therapy Alone|"drug therapy alone~Oxybutynin chloride, extended-release: Individually-titrated, extended-release oxybutynin chloride with management of side-effects."
1219455|NCT00223821|O2|Outcome|Drug Therapy + Behavioral Training|"Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.~Behavior Training : Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training."
1219456|NCT00223821|O1|Outcome|Drug Therapy Alone|Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.
1219457|NCT00223821|O2|Outcome|Drug Therapy + Behavioral Training|"Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.~Behavior Training : Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training."
1219458|NCT00223821|O1|Outcome|Drug Therapy Alone|Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.
1219459|NCT00223821|E2|Reported Event|Arm 2|"drug therapy + behavioral training~Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.~Behavior Training : Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training."
1219460|NCT00223821|E1|Reported Event|Arm 1|"drug therapy alone~Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects."
1219461|NCT00223808|B4|Baseline|Total|Total of all reporting groups
1219462|NCT00223808|B3|Baseline|Control|Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot
1219521|NCT00223678|O2|Outcome|CNI Group|Patient will remain on calcineruin inhibitor with a low target serum levels 50ng/ml to 125ng/mg 12 hour trough
1219463|NCT00223808|B2|Baseline|Robot-High|Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy
1219464|NCT00223808|B1|Baseline|Robot-Low|Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy
1219465|NCT00223808|P3|Participant Flow|Control|Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot
1219466|NCT00223808|P2|Participant Flow|Robot-High|Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy
1219467|NCT00223808|P1|Participant Flow|Robot-Low|Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy
1219468|NCT00223808|O3|Outcome|Control|Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot. Maximum number of hours = 15.
1219469|NCT00223808|O2|Outcome|Robot-High|Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy. Maximum number of hours = 30.
1219470|NCT00223808|O1|Outcome|Robot-Low|Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy. Maximum number of hours = 15.
1219471|NCT00223808|O3|Outcome|Control|Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot. Maximum number of hours = 15.
1219472|NCT00223808|O2|Outcome|Robot-High|Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy. Maximum number of hours = 30.
1219473|NCT00223808|O1|Outcome|Robot-Low|Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy. Maximum number of hours = 15.
1219474|NCT00223808|O3|Outcome|Control|Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot. Maximum number of hours = 15.
1219475|NCT00223808|O2|Outcome|Robot-High|Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy. Maximum number of hours = 30.
1219476|NCT00223808|O1|Outcome|Robot-Low|Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy. Maximum number of hours = 15.
1219477|NCT00223808|O3|Outcome|Control|Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot. Maximum number of hours = 15.
1219478|NCT00223808|O2|Outcome|Robot-High|Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy. Maximum number of hours = 30.
1219479|NCT00223808|O1|Outcome|Robot-Low|Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy. Maximum number of hours = 15.
1219480|NCT00223808|E3|Reported Event|Control|Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot
1219481|NCT00223808|E2|Reported Event|Robot-High|Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy
1219482|NCT00223808|E1|Reported Event|Robot-Low|Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy
1219483|NCT00223795|B1|Baseline|Baseline Characteristics All Subjects|Community-dwelling patients with unilateral knee pain on movement which they scored at >35 mm on a 100-mm visual analogue scale (VAS) for most days of the previous month. Other inclusion criteria included having a weight less than 300 pounds, no cane use for the past 30 days, fulfillment of the American College of Rheumatology criteria for knee OA , and radiographic Kellgren-Lawrence scale knee OA grade > 1. We excluded individuals who had knee trauma or surgery, including arthroscopic surgery, within the past six months, upper body weakness, injury or amputation to the lower extremity joints, symptomatic spine, hip, ankle, or foot disease that would interfere with assessment of the knee, poor health that would impair compliance or assessment such as shortness of breath with exertion, or neurological disease including vestibular dysfunction, or impaired vision.
1219484|NCT00223795|P2|Participant Flow|Arm 2 - Cane|Single point cane first, then continue with single point cane
1219485|NCT00223795|P1|Participant Flow|Arm 1 - Control/Crossover|No cane first, then single point cane
1219486|NCT00223795|O2|Outcome|Arm 2- Cane Users|Study participants with symptomatic knee OA underwent gait analysis while walking with and without a cane at baseline and at end of first intervention period (2 months). Participants given a cane to use at home during the first intervention period and then for four months after the first intervention period.
1219514|NCT00223704|E2|Reported Event|Aminocaproic Acid Group|Aminocaproic acid is an antifibrinolytic drug
1219487|NCT00223795|O1|Outcome|Arm 1 - Waiting Control|Study participants with symptomatic knee OA underwent gait analysis while walking with and without a cane at baseline and at end of first intervention period (2 months). Participants not given a cane to use at home during the intervention period. They were given a cane to use for four months after the first intervention period
1219488|NCT00223795|E3|Reported Event|Arm 2- Single Point Cane|single point cane for 8 weeks then single point cane for next 4 months
1219489|NCT00223795|E2|Reported Event|Arm 1 - Intervention - Crossover to Cane|Given single point cane to use for 4 months following 8 weeks without a cane
1219490|NCT00223795|E1|Reported Event|Arm 1: Intervention - no Cane for First 8 Weeks|No cane for first 8 weeks
1219491|NCT00223704|B4|Baseline|Total|Total of all reporting groups
1219492|NCT00223704|B3|Baseline|HOE 140 Group|Bradykinin B2 receptor antagonist
1219493|NCT00223704|B2|Baseline|Aminocaproic Acid Group|Aminocaproic acid is an antifibrinolytic drug
1219494|NCT00223704|B1|Baseline|Placebo Group|Placebo was normal saline
1220606|NCT00214019|O4|Outcome|Salmeterol/Fluticasone|Participants on Salmeterol/Fluticasone
1219495|NCT00223704|P3|Participant Flow|HOE 140 Group|HOE 140 (a bradykinin B2 receptor antagonist) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. HOE 140 was given as an intravenous bolus of 22 µg/kg over one-half hour followed by an infusion of 18 µg/kg/hr.
1219496|NCT00223704|P2|Participant Flow|Aminocaproic Acid Group|Aminocaproic acid (an antifibrinolytic drug) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. Aminocaproic acid was given as an intravenous bolus of 100 mg/kg over one-half hour followed by an infusion of 30 mg/kg/hr.
1219497|NCT00223704|P1|Participant Flow|Placebo Group|Normal saline (placebo) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery.
1219498|NCT00223704|O3|Outcome|HOE 140 Group|HOE 140 (a bradykinin B2 receptor antagonist) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. HOE 140 was given as an intravenous bolus of 22 µg/kg over one-half hour followed by an infusion of 18 µg/kg/hr.
1219499|NCT00223704|O2|Outcome|Aminocaproic Acid Group|Aminocaproic acid (an antifibrinolytic drug) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. Aminocaproic acid was given as an intravenous bolus of 100 mg/kg over one-half hour followed by an infusion of 30 mg/kg/hr.
1219500|NCT00223704|O1|Outcome|Placebo Group|Normal saline (placebo) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery.
1219501|NCT00223704|O3|Outcome|HOE 140 Group|HOE 140 (a bradykinin B2 receptor antagonist) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. HOE 140 was given as an intravenous bolus of 22 µg/kg over one-half hour followed by an infusion of 18 µg/kg/hr.
1219502|NCT00223704|O2|Outcome|Aminocaproic Acid Group|Aminocaproic acid (an antifibrinolytic drug) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. Aminocaproic acid was given as an intravenous bolus of 100 mg/kg over one-half hour followed by an infusion of 30 mg/kg/hr.
1219503|NCT00223704|O1|Outcome|Placebo Group|Normal saline (placebo) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery.
1219504|NCT00223704|O3|Outcome|HOE 140 Group|HOE 140 (a bradykinin B2 receptor antagonist) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. HOE 140 was given as an intravenous bolus of 22 µg/kg over one-half hour followed by an infusion of 18 µg/kg/hr.
1219505|NCT00223704|O2|Outcome|Aminocaproic Acid Group|Aminocaproic acid (an antifibrinolytic drug) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. Aminocaproic acid was given as an intravenous bolus of 100 mg/kg over one-half hour followed by an infusion of 30 mg/kg/hr.
1219506|NCT00223704|O1|Outcome|Placebo Group|Normal saline (placebo) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery.
1219507|NCT00223704|O3|Outcome|HOE 140 Group|HOE 140 (a bradykinin B2 receptor antagonist) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. HOE 140 was given as an intravenous bolus of 22 µg/kg over one-half hour followed by an infusion of 18 µg/kg/hr.
1219508|NCT00223704|O2|Outcome|Aminocaproic Acid Group|Aminocaproic acid (an antifibrinolytic drug) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. Aminocaproic acid was given as an intravenous bolus of 100 mg/kg over one-half hour followed by an infusion of 30 mg/kg/hr.
1219509|NCT00223704|O1|Outcome|Placebo Group|Normal saline (placebo) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery.
1219510|NCT00223704|O3|Outcome|HOE 140 Group|HOE 140 (a bradykinin B2 receptor antagonist) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. HOE 140 was given as an intravenous bolus of 22 µg/kg over one-half hour followed by an infusion of 18 µg/kg/hr.
1219511|NCT00223704|O2|Outcome|Aminocaproic Acid Group|Aminocaproic acid (an antifibrinolytic drug) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. Aminocaproic acid was given as an intravenous bolus of 100 mg/kg over one-half hour followed by an infusion of 30 mg/kg/hr.
1219512|NCT00223704|O1|Outcome|Placebo Group|Normal saline (placebo) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery.
1219513|NCT00223704|E3|Reported Event|HOE 140 Group|Bradykinin B2 receptor antagonist
1219515|NCT00223704|E1|Reported Event|Placebo Group|Placebo was normal saline
1219516|NCT00223678|B3|Baseline|Total|Total of all reporting groups
1219517|NCT00223678|B2|Baseline|CYA/Prograf|Patient will remain on calcineruin inhibitor,CYA/Prograf
1219518|NCT00223678|B1|Baseline|Rapamycin|"pt will switch from calcineurin inhibitor (CYA, prograf) to Rapamycin~Rapamycin: Rapamycin will start within 24 hours of last calcineurin inhibitors (Cya, Prgraf). Initial dose of Rapamune 10mg will be given for 3 days and then dose will be adjusted to attain a target whole blood trough of 5-15"
1219519|NCT00223678|P2|Participant Flow|CYA/Prograf|Patient will remain on calcineruin inhibitor,CYA/Prograf
1219520|NCT00223678|P1|Participant Flow|Rapamycin|"pt will switch from calcineurin inhibitor (CYA, prograf) to Rapamycin~Rapamycin: Rapamycin will start within 24 hours of last calcineurin inhibitors (Cya, Prgraf). Initial dose of Rapamune 10mg will be given for 3 days and then dose will be adjusted to attain a target whole blood trough of 5-15"
1235830|NCT00132873|P1|Participant Flow|Xyrem (Sodium Oxybate)|
1219522|NCT00223678|O1|Outcome|Rapamycin Group|pt will switch from calcineurin inhibitor (CYA, prograf) to Rapamycin.Rapamycin: Rapamycin will start within 24 hours of last calcineurin inhibitors (Cya, Prgraf). Initial dose of Rapamune 10mg will be given for 3 days and then dose will be adjusted to attain a target whole blood trough of 5-15
1219523|NCT00223678|E2|Reported Event|CNI Group|
1219524|NCT00223678|E1|Reported Event|Rapamycin Group|
1219525|NCT00223652|B3|Baseline|Total|Total of all reporting groups
1219526|NCT00223652|B2|Baseline|Treatment as Usual|Treatment as usual control.
1219527|NCT00223652|B1|Baseline|Telephone-administered Cognitive-Behavioral Therapy|"Telephone cognitive behavioral therapy~Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
1219528|NCT00223652|P2|Participant Flow|Treatment as Usual|Treatment as usual control.
1219529|NCT00223652|P1|Participant Flow|Telephone-administered Cognitive-Behavioral Therapy|"Telephone cognitive behavioral therapy~Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
1219530|NCT00223652|O2|Outcome|Treatment as Usual|Treatment as usual control.
1219531|NCT00223652|O1|Outcome|Telephone Cognitive Behavioral Therapy|"Telephone cognitive behavioral therapy~Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
1219532|NCT00223652|O2|Outcome|Treatment as Usual|Treatment as usual control.
1219533|NCT00223652|O1|Outcome|Telephone Cognitive Behavioral Therapy|"Telephone cognitive behavioral therapy~Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
1219534|NCT00223652|O2|Outcome|Treatment as Usual|Treatment as usual control.
1219535|NCT00223652|O1|Outcome|Telephone-administered Cognitive-Behavioral Therapy|"Telephone cognitive behavioral therapy~Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
1219536|NCT00223652|O2|Outcome|Treatment as Usual|Treatment as usual control.
1219537|NCT00223652|O1|Outcome|Telephone-administered Cognitive-Behavioral Therapy|"Telephone cognitive behavioral therapy~Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
1219538|NCT00223652|O2|Outcome|Treatment as Usual|Treatment as usual control.
1219539|NCT00223652|O1|Outcome|Telephone-administered Cognitive-Behavioral Therapy|"Telephone cognitive behavioral therapy~Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
1219540|NCT00223652|O2|Outcome|Treatment as Usual|Treatment as usual control.
1219541|NCT00223652|O1|Outcome|Telephone-administered Cognitive-Behavioral Therapy|"Telephone cognitive behavioral therapy~Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
1219542|NCT00223652|E2|Reported Event|Treatment as Usual|Treatment as usual control.
1219543|NCT00223652|E1|Reported Event|Telephone-administered Cognitive-Behavioral Therapy|"Telephone cognitive behavioral therapy~Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
1219544|NCT00223496|B1|Baseline|Aripiprazole|Study recruited subjects with bipolar disorder who were currently in a depressed state according to rating scales. Subjects were started on divalproex. After 3 weeks on divalproex if patients were still exhibiting depression symptoms then they were started on aripriprazole in addition to divalproex. Those subject who were no longer in a depressed state were terminated from study. Subjects proceeded in study on both medications and were assessed by physician for depression and mania symtpoms using rating scales, until end of study.
1219578|NCT00221299|B1|Baseline|Parathyroid Hormone Injections and Risedronate Placebo Tablets|"parathyroid hormone (rhPTH 1-34) injections and risedronate placebo tablets for one year~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
1219545|NCT00223496|P1|Participant Flow|Aripiprazole Plus Divalproex ER|Study recruited subjects with bipolar disorder who were currently in a depressed state according to rating scales. Subjects were started on divalproex. After 3 weeks on divalproex if patients were still exhibiting depression symptoms then they were started on aripriprazole in addition to divalproex. Those subject who were no longer in a depressed state were terminated from study. Subjects proceeded in study on both medications and were assessed by physician for depression and mania symtpoms using rating scales, until end of study.
1219546|NCT00223496|O1|Outcome|Aripiprazole Plus Divalalproex ER|Study recruited subjects with bipolar disorder who were currently in a depressed state according to rating scales. Subjects were started on divalproex. After 3 weeks on divalproex if patients were still exhibiting depression symptoms then they were started on aripriprazole in addition to divalproex. Those subject who were no longer in a depressed state were terminated from study. Subjects proceeded in study on both medications and were assessed by physician for depression and mania symtpoms using rating scales, until end of study.
1219613|NCT00220961|O1|Outcome|Placebo|"Placebo tablet similar to pioglitazone tablet~Placebo: Placebo tablets similar to pioglitazone tablets"
1219547|NCT00223496|E1|Reported Event|Aripiprazole Plus Divalproex ER|Study recruited subjects with bipolar disorder who were currently in a depressed state according to rating scales. Subjects were started on divalproex. After 3 weeks on divalproex if patients were still exhibiting depression symptoms then they were started on aripriprazole in addition to divalproex. Those subject who were no longer in a depressed state were terminated from study. Subjects proceeded in study on both medications and were assessed by physician for depression and mania symtpoms using rating scales, until end of study.
1219548|NCT00223236|B3|Baseline|Total|Total of all reporting groups
1219549|NCT00223236|B2|Baseline|Placebo|Inactive ingredient matching the active medication in appearance
1219550|NCT00223236|B1|Baseline|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
1219551|NCT00223236|P2|Participant Flow|Placebo|Inactive ingredient matching the active medication in appearance
1219552|NCT00223236|P1|Participant Flow|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
1219553|NCT00223236|O2|Outcome|Placebo|Inactive ingredient matching the active medication in appearance
1219554|NCT00223236|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
1219555|NCT00223236|O2|Outcome|Placebo|Inactive ingredient matching the active medication in appearance
1219556|NCT00223236|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
1219557|NCT00223236|O2|Outcome|Placebo|Inactive ingredient matching the active medication in appearance
1219558|NCT00223236|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
1219559|NCT00223236|O2|Outcome|Placebo|Inactive ingredient matching the active medication in appearance
1219560|NCT00223236|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
1219561|NCT00223236|E2|Reported Event|Placebo|Inactive ingredient matching the active medication in appearance
1219562|NCT00223236|E1|Reported Event|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
1219563|NCT00222729|B1|Baseline|Pemetrexed + Bevacizumab|Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
1219564|NCT00222729|P1|Participant Flow|Pemetrexed + Bevacizumab|Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
1219565|NCT00222729|O1|Outcome|Pemetrexed + Bevacizumab|Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
1219566|NCT00222729|O1|Outcome|Pemetrexed + Bevacizumab|Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
1219567|NCT00222729|O1|Outcome|Pemetrexed + Bevacizumab|Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
1219568|NCT00222729|O1|Outcome|Pemetrexed + Bevacizumab|Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
1219569|NCT00222729|E1|Reported Event|Pemetrexed + Bevacizumab|Patients with previously untreated, recurrent, or metastatic SCCHN were treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
1219570|NCT00222105|B1|Baseline|Arm 1|"Doxil, Thalidomide, Dexamethasone~Doxil: Doxil 40 mg/m2 IV day 1~Thalidomide: 50-100 mg day 1-28~Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18"
1219571|NCT00222105|P1|Participant Flow|Arm 1|"Doxil, Thalidomide, Dexamethasone~Doxil: Doxil 40 mg/m2 IV day 1~Thalidomide: 50-100 mg day 1-28~Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18"
1219572|NCT00222105|O1|Outcome|Arm 1|"Doxil, Thalidomide, Dexamethasone~Doxil: Doxil 40 mg/m2 IV day 1~Thalidomide: 50-100 mg day 1-28~Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18"
1219573|NCT00222105|O1|Outcome|Arm 1|"Doxil, Thalidomide, Dexamethasone~Doxil: Doxil 40 mg/m2 IV day 1~Thalidomide: 50-100 mg day 1-28~Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18"
1219574|NCT00222105|E1|Reported Event|Arm 1|"Doxil, Thalidomide, Dexamethasone~Doxil: Doxil 40 mg/m2 IV day 1~Thalidomide: 50-100 mg day 1-28~Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18"
1219575|NCT00221299|B4|Baseline|Total|Total of all reporting groups
1219576|NCT00221299|B3|Baseline|Parathyroid Hormone Placebo Injections and Risedronate Tables|"parathyroid hormone (rhPTH 1-34) placebo injections and risedronate tablets for one year~Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year."
1219577|NCT00221299|B2|Baseline|Parathyroid Hormone Injections and Risedronate Tablets|"Parathyroid hormone (rhPTH 1-34) injections and risedronate tablets for one year~Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year.~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
1219608|NCT00220961|O2|Outcome|Pioglitazone|"Pioglitazone tablet similar to placebo tablet~Pioglitazone: Pioglitazone tablets"
1219866|NCT00218634|O1|Outcome|CBT-AD|Cognitive behavioral therapy for adherence and depression
1219579|NCT00221299|P4|Participant Flow|Group3-rhPTH-Placebo&Risedronate|"First phase (year 1) - parathyroid hormone (rhPTH 1-34), placebo SC injections of normal saline daily and risedronate tablets (35mg/wk) tablets for one year Second phase (year 2) - continue on risedronate tablets (35mg/wk) for second year.~Risedronate: One 35mg tab of risedronate/placebo taken once a week for two years.~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
1219614|NCT00220961|E2|Reported Event|Pioglitazone|"Pioglitazone tablet similar to placebo tablet~Pioglitazone: Pioglitazone tablets"
1219615|NCT00220961|E1|Reported Event|Placebo|"Placebo tablet similar to pioglitazone tablet~Placebo: Placebo tablets similar to pioglitazone tablets"
1219616|NCT00220805|B3|Baseline|Total|Total of all reporting groups
1219617|NCT00220805|B2|Baseline|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
1219580|NCT00221299|P3|Participant Flow|Group2-rhPTH&Risedronate|"First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate tablets (35mg/wk) tablets for one year Second phase (year 2) - continue on risedronate tablets (35mg/wk) for second year.~Risedronate: One 35mg tab of risedronate/placebo taken once a week for two years.~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
1219581|NCT00221299|P2|Participant Flow|Group1b-rhPTH&RisendronatePlacebo|"First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate placebo tablets for one year Second phase (year 2) - continue on risedronate placebo tablets for second year.~Risedronate: One 35mg tab of risedronate/placebo taken once a week for two years.~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
1219582|NCT00221299|P1|Participant Flow|Group1a-rhPTH&RIS-Placebo(Y1)&RIS(Y2)|"First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate placebo tablets for one year Second phase (year 2) - re-randomized to risedronate (35mg/wk) tablets for second year.~Risedronate: One 35mg tab of risedronate/placebo taken once a week for year 1. One 35mg tab of risedronate taken once a week for year 2.~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
1219583|NCT00221299|O3|Outcome|Parathyroid Hormone Placebo&Risedronate|"parathyroid hormone (rhPTH 1-34) placebo injections and risedronate tablets for one year~Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year."
1219584|NCT00221299|O2|Outcome|Parathyroid Hormone&Risedronate|"Parathyroid hormone (rhPTH 1-34) injections and risedronate tablets for one year~Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year.~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
1219585|NCT00221299|O1|Outcome|Parathyroid Hormone&Risedronate Placebo|"parathyroid hormone (rhPTH 1-34) injections and risedronate placebo tablets for one year~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
1219586|NCT00221299|E3|Reported Event|Parathyroid Hormone Placebo Injections and Risedronate Tablets|"parathyroid hormone (rhPTH 1-34) placebo injections and risedronate tablets for one year~Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year."
1219587|NCT00221299|E2|Reported Event|Parthyroid Hormone Injections and Risedronte Tablets|"Parathyroid hormone (rhPTH 1-34) injections and risedronate tablets for one year~Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year.~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
1219588|NCT00221299|E1|Reported Event|Parathyroid Hormone Injections and Risedronate Placebo Tablets|"parathyroid hormone (rhPTH 1-34) injections and risedronate placebo tablets for one year~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
1219589|NCT00221195|B3|Baseline|Total|Total of all reporting groups
1219590|NCT00221195|B2|Baseline|Prophylaxis First|Patients receive 6 months of prophylaxis therapy with study drug followed by 6 months on-demand therapy with study drug
1219591|NCT00221195|B1|Baseline|On-demand First|Patients receive 6 months of on-demand therapy with study drug followed by 6 months of prophylaxis therapy with study drug
1219592|NCT00221195|P2|Participant Flow|Prophylaxis First|Patients receive 6 months of prophylaxis therapy with study drug followed by 6 months on-demand therapy with study drug
1219593|NCT00221195|P1|Participant Flow|On-demand First|Patients receive 6 months of on-demand therapy with study drug followed by 6 months of prophylaxis therapy with study drug
1219594|NCT00221195|O2|Outcome|Bleeds During the Prophylaxis Period|
1219595|NCT00221195|O1|Outcome|Bleeds During the On-demand Period|
1219596|NCT00221195|E3|Reported Event|Washout Period|
1219597|NCT00221195|E2|Reported Event|Prophylaxis Period|
1219598|NCT00221195|E1|Reported Event|On-demand Period|
1219599|NCT00220961|B3|Baseline|Total|Total of all reporting groups
1219600|NCT00220961|B2|Baseline|Pioglitazone|"Pioglitazone tablet similar to placebo tablet~Pioglitazone: Pioglitazone tablets"
1219601|NCT00220961|B1|Baseline|Placebo|"Placebo tablet similar to pioglitazone tablet~Placebo: Placebo tablets similar to pioglitazone tablets"
1219602|NCT00220961|P2|Participant Flow|Pioglitazone|"Pioglitazone tablet similar to placebo tablet~Pioglitazone: Pioglitazone tablets - 45mg/day tablet"
1219603|NCT00220961|P1|Participant Flow|Placebo|"Placebo tablet similar to pioglitazone tablet~Placebo: Placebo tablets similar to pioglitazone tablets - 1 tablet/day"
1219604|NCT00220961|O2|Outcome|Pioglitazone|"Pioglitazone tablet similar to placebo tablet~Pioglitazone: Pioglitazone tablets"
1219605|NCT00220961|O1|Outcome|Placebo|"Placebo tablet similar to pioglitazone tablet~Placebo: Placebo tablets similar to pioglitazone tablets"
1219606|NCT00220961|O2|Outcome|Pioglitazone|"Pioglitazone tablet similar to placebo tablet~Pioglitazone: Pioglitazone tablets"
1219607|NCT00220961|O1|Outcome|Placebo|"Placebo tablet similar to pioglitazone tablet~Placebo: Placebo tablets similar to pioglitazone tablets"
1219867|NCT00218634|O2|Outcome|ETAU|Enhanced Treatment as Usual
1219609|NCT00220961|O1|Outcome|Placebo|"Placebo tablet similar to pioglitazone tablet~Placebo: Placebo tablets similar to pioglitazone tablets"
1219610|NCT00220961|O2|Outcome|Pioglitazone|"Pioglitazone tablet similar to placebo tablet~Pioglitazone: Pioglitazone tablets"
1219611|NCT00220961|O1|Outcome|Placebo|"Placebo tablet similar to pioglitazone tablet~Placebo: Placebo tablets similar to pioglitazone tablets"
1219612|NCT00220961|O2|Outcome|Pioglitazone|"Pioglitazone tablet similar to placebo tablet~Pioglitazone: Pioglitazone tablets"
1219618|NCT00220805|B1|Baseline|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
1219619|NCT00220805|P2|Participant Flow|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
1219620|NCT00220805|P1|Participant Flow|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
1219621|NCT00220805|O2|Outcome|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
1219622|NCT00220805|O1|Outcome|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
1219623|NCT00220805|O2|Outcome|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
1219624|NCT00220805|O1|Outcome|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
1219625|NCT00220805|O2|Outcome|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
1219626|NCT00220805|O1|Outcome|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
1219627|NCT00220805|O2|Outcome|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
1219628|NCT00220805|O1|Outcome|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
1219629|NCT00220805|O2|Outcome|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
1219630|NCT00220805|O1|Outcome|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
1219631|NCT00220805|O2|Outcome|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
1219632|NCT00220805|O1|Outcome|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
1219633|NCT00220805|O2|Outcome|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
1219634|NCT00220805|O1|Outcome|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
1219635|NCT00220805|E2|Reported Event|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
1219636|NCT00220805|E1|Reported Event|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
1219637|NCT00220779|B4|Baseline|Total|Total of all reporting groups
1219638|NCT00220779|B3|Baseline|Placebo (0.1% Albumin) 4 mL/kg bw/Infusion|
1219639|NCT00220779|B2|Baseline|IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg bw)|
1219640|NCT00220779|B1|Baseline|IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg bw)|
1219641|NCT00220779|P3|Participant Flow|Placebo (0.1% Albumin) 4 mL/kg Body Weight/Infusion|Immune globulin (intravenous) (IGIV)
1219642|NCT00220779|P2|Participant Flow|IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg Body Weight)|Immune globulin (intravenous) (IGIV)
1219643|NCT00220779|P1|Participant Flow|IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg Body Weight)|Immune globulin (intravenous) (IGIV)
1219644|NCT00220779|O3|Outcome|Placebo (0.1% Albumin) 4 mL/kg bw/Infusion|
1219645|NCT00220779|O2|Outcome|IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg bw)|
1219646|NCT00220779|O1|Outcome|IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg bw)|
1219647|NCT00220779|E3|Reported Event|Placebo (0.1% Albumin) 4 mL/kg bw/Infusion|
1219648|NCT00220779|E2|Reported Event|IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg bw)|
1219649|NCT00220779|E1|Reported Event|IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg bw)|
1219650|NCT00220740|B3|Baseline|Total|Total of all reporting groups
1219651|NCT00220740|B2|Baseline|Placebo|.1% albumin, 2 g/kg loading dose, followed by 1 g/kg maintenance dose
1219652|NCT00220740|B1|Baseline|IGIV-C|2 g/kg loading dose, followed by 1 g/kg maintenance dose
1219653|NCT00220740|P2|Participant Flow|Placebo|.1% albumin; 2g/kg loading dose and 1 g/kg maintenance dose
1219654|NCT00220740|P1|Participant Flow|IGIV-C|2 g/kg loading dose, followed by 1 g/kg maintenance dose
1219655|NCT00220740|O2|Outcome|Placebo|.1% albumin; 2g/kg loading dose and 1 g/kg maintenance dose
1219656|NCT00220740|O1|Outcome|IGIV-C|2 g/kg loading dose, followed by 1 g/kg maintenance dose
1219657|NCT00220740|O2|Outcome|Placebo|.1% albumin; 2g/kg loading dose and 1 g/kg maintenance dose
1219658|NCT00220740|O1|Outcome|IGIV-C|2 g/kg loading dose, followed by 1 g/kg maintenance dose
1219659|NCT00220740|O2|Outcome|Placebo|.1% albumin; 2g/kg loading dose and 1 g/kg maintenance dose
1219660|NCT00220740|O1|Outcome|IGIV-C|2 g/kg loading dose, followed by 1 g/kg maintenance dose
1219661|NCT00220740|O2|Outcome|Placebo|
1219662|NCT00220740|O1|Outcome|IGIV-C|
1219663|NCT00220740|E2|Reported Event|Placebo|".1% albumin; 2g/kg loading dose and 1 g/kg maintenance dose.~A total of 95 subjects were exposed to Placebo across all three treatments/periods."
1219664|NCT00220740|E1|Reported Event|IGIV-C|"2 g/kg loading dose, followed by 1 g/kg maintenance dose.~A total of 113 subjects were exposed to IGIV-C across all three treatments/periods."
1219665|NCT00220727|B3|Baseline|Total|Total of all reporting groups
1219666|NCT00220727|B2|Baseline|IGIV-C, 10% - 0.14/0.08 mL/kg/Min|Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.08 mL/kg/min)
1219667|NCT00220727|B1|Baseline|IGIV-C, 10% - 0.08/0.14 mL/kg/Min|Infusion #1 (Week 0 IGIV-C (0.08 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.14 mL/kg/min)
1219668|NCT00220727|P2|Participant Flow|IGIV-C, 10% - 0.14/0.08 mL/kg/Min|Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.08 mL/kg/min)
1219669|NCT00220727|P1|Participant Flow|IGIV-C, 10% - 0.08/0.14 mL/kg/Min|Infusion #1 (Week 0 IGIV-C (0.08 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.14 mL/kg/min)
1219670|NCT00220727|O2|Outcome|IGIV-C, 10% (0.14 mL/kg/Min)|Rapid Infusion Rate IGIV-C (0.14 mL/kg/min);
1219671|NCT00220727|O1|Outcome|IGIV-C, 10% (0.08 mL/kg/Min)|Slow Infusion Rate IGIV-C (0.08 mL/kg/min);
1219672|NCT00220727|O2|Outcome|IGIV-C, 10% (0.14 mL/kg/Min)|Rapid Infusion Rate IGIV-C (0.14 mL/kg/min);
1219673|NCT00220727|O1|Outcome|IGIV-C, 10% (0.08 mL/kg/Min)|Slow Infusion Rate IGIV-C (0.08 mL/kg/min);
1219674|NCT00220727|O2|Outcome|IGIV-C, 10% (0.14 mL/kg/Min)|Rapid Infusion Rate IGIV-C (0.14 mL/kg/min);
1219675|NCT00220727|O1|Outcome|IGIV-C, 10% (0.08 mL/kg/Min)|Slow Infusion Rate IGIV-C (0.08 mL/kg/min);
1219676|NCT00220727|O2|Outcome|IGIV-C, 10% (0.14 mL/kg/Min)|Rapid Infusion Rate IGIV-C (0.14 mL/kg/min);
1219677|NCT00220727|O1|Outcome|IGIV-C, 10% (0.08 mL/kg/Min)|Slow Infusion Rate IGIV-C (0.08 mL/kg/min);
1219678|NCT00220727|O2|Outcome|IGIV-C, 10% (0.14 mL/kg/Min)|Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.08 mL/kg/min)
1219679|NCT00220727|O1|Outcome|IGIV-C, 10% (0.08 mL/kg/Min)|Infusion #1 (Week 0 IGIV-C (0.08 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.14 mL/kg/min)
1219680|NCT00220727|E2|Reported Event|IGIV-C, 10% - 0.14 mL/kg/Min|IGIV-C (0.14 mL/kg/min);
1219681|NCT00220727|E1|Reported Event|IGIV-C, 10% - 0.08 mL/kg/Min|IGIV-C (0.08 mL/kg/min);
1219682|NCT00220701|B3|Baseline|Total|Total of all reporting groups
1219683|NCT00220701|B2|Baseline|Placebo|"inactive comparator~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
1219684|NCT00220701|B1|Baseline|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
1219685|NCT00220701|P2|Participant Flow|Placebo|"inactive comparator~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
1219686|NCT00220701|P1|Participant Flow|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
1219687|NCT00220701|O2|Outcome|Placebo|"inactive comparator~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
1219688|NCT00220701|O1|Outcome|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
1219689|NCT00220701|O2|Outcome|Placebo|"inactive comparator~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
1219690|NCT00220701|O1|Outcome|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
1219691|NCT00220701|O2|Outcome|Placebo|"inactive comparator~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
1219692|NCT00220701|O1|Outcome|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
1219693|NCT00220701|O2|Outcome|Placebo|"inactive comparator~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
1219694|NCT00220701|O1|Outcome|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
1219695|NCT00220701|O2|Outcome|Placebo|"inactive comparator~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
1219696|NCT00220701|O1|Outcome|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
1219697|NCT00220701|O2|Outcome|Placebo|"inactive comparator~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
1219698|NCT00220701|O1|Outcome|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
1219699|NCT00220701|E2|Reported Event|Placebo|"inactive comparator~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
1219700|NCT00220701|E1|Reported Event|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
1219701|NCT00220636|B1|Baseline|Aripiprazole|aripiprazole augmentation treatment
1219702|NCT00220636|P1|Participant Flow|Aripiprazole|aripiprazole augmentation treatment
1219703|NCT00220636|O1|Outcome|Aripiprazole|aripiprazole augmentation treatment
1219704|NCT00220636|O1|Outcome|Aripiprazole|aripiprazole augmentation treatment
1219705|NCT00220636|O1|Outcome|Aripiprazole|aripiprazole augmentation treatment for treatment resistant depression
1219706|NCT00220636|O1|Outcome|Aripiprazole|aripiprazole augmentation treatment
1219707|NCT00220636|E1|Reported Event|Aripiprazole|aripiprazole augmentation treatment
1219708|NCT00219557|B4|Baseline|Total|Total of all reporting groups
1219709|NCT00219557|B3|Baseline|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1219710|NCT00219557|B2|Baseline|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1219711|NCT00219557|B1|Baseline|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1219712|NCT00219557|P3|Participant Flow|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1219713|NCT00219557|P2|Participant Flow|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1219714|NCT00219557|P1|Participant Flow|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1219715|NCT00219557|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1219716|NCT00219557|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1219717|NCT00219557|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1220607|NCT00214019|O3|Outcome|Placebo/fFuticasone|Participants on Placebo/Fluticasone arm
1219718|NCT00219557|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1219719|NCT00219557|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1219720|NCT00219557|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1219721|NCT00219557|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1219722|NCT00219557|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1219723|NCT00219557|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1219724|NCT00219557|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1219725|NCT00219557|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1219726|NCT00219557|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1219727|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1219728|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1219729|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1219730|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1219731|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1219732|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1219733|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1219734|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1219735|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1219736|NCT00219557|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1219737|NCT00219557|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1219738|NCT00219557|E3|Reported Event|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1219739|NCT00219557|E2|Reported Event|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally twice daily (BID) from Day 1 of Cycle 1 (28 days) and all subsequent cycles (28 days). Gemcitabine 1000 mg/m^2 30-minute infusion on Day 1, 8 and 15 of each cycle.
1219740|NCT00219557|E1|Reported Event|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
1219741|NCT00219544|B1|Baseline|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
1219742|NCT00219544|P2|Participant Flow|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
1219743|NCT00219544|P1|Participant Flow|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
1219744|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
1219745|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
1219746|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
1219747|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
1219748|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
1219749|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
1219750|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
1219751|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
1219752|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
1219753|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
1219754|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
1219755|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
1219756|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
1219757|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
1219758|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
1219781|NCT00219349|P1|Participant Flow|Cognitive-behavioral Therapy|14 weekly sessions of individual cognitive-behavioral therapy
1219782|NCT00219349|O1|Outcome|Patients Who Started Escitalopram|Patients who completed the CBT phase and started escitalopram phase treatment
1219783|NCT00219349|E1|Reported Event|Group 1|all subject entered
1219759|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
1219760|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed.
1219761|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
1219833|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
1219762|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
1219763|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
1219764|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
1219765|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
1219766|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
1219767|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed.
1219768|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed.
1219769|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed.
1219770|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
1219771|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
1219772|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
1219773|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
1219774|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed.
1219775|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
1219776|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
1219777|NCT00219544|E3|Reported Event|Placebo Double-blind Phase|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
1219778|NCT00219544|E2|Reported Event|Pregabalin Double-blind Phase|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatent phase.
1219779|NCT00219544|E1|Reported Event|Pregabalin Single-blind Phase|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed.
1219780|NCT00219349|B1|Baseline|Cognitive-behavioral Therapy|14 weekly sessions of individual cognitive-behavioral therapy
1219784|NCT00219284|B3|Baseline|Total|Total of all reporting groups
1219785|NCT00219284|B2|Baseline|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
1219834|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
1219786|NCT00219284|B1|Baseline|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
1219787|NCT00219284|P2|Participant Flow|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
1219788|NCT00219284|P1|Participant Flow|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
1219789|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
1219790|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
1219791|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
1219792|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
1219793|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
1219794|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
1219828|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
1219868|NCT00218634|O1|Outcome|CBT-AD|Cognitive behavioral therapy for adherence and depression
1219795|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
1219796|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
1219797|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
1219798|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
1219799|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
1219800|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
1219801|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
1219802|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
1219803|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
1219804|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
1219829|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
1219830|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
1219805|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
1219806|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
1219807|NCT00219284|E2|Reported Event|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
1219808|NCT00219284|E1|Reported Event|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
1219809|NCT00219141|B4|Baseline|Total|Total of all reporting groups
1219810|NCT00219141|B3|Baseline|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
1219811|NCT00219141|B2|Baseline|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
1219812|NCT00219141|B1|Baseline|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
1219813|NCT00219141|P3|Participant Flow|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
1219814|NCT00219141|P2|Participant Flow|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
1219815|NCT00219141|P1|Participant Flow|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
1219816|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
1219817|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
1219818|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
1219819|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
1219820|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
1219821|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
1219822|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
1219823|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
1219824|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
1219825|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
1219826|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
1219827|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
1219865|NCT00218634|O2|Outcome|ETAU|Enhanced Treatment as Usual
1219831|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
1219832|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
1219880|NCT00218634|E1|Reported Event|CBT-AD|Cognitive behavioral therapy for adherence and depression
1219835|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
1219836|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
1219837|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
1219838|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
1219839|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
1219840|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
1219841|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
1219842|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
1219843|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
1219844|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
1219845|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
1219846|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
1219847|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
1219848|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
1219849|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
1219850|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
1219851|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
1219852|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
1219853|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
1219854|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
1219855|NCT00219141|E3|Reported Event|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
1219856|NCT00219141|E2|Reported Event|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
1219857|NCT00219141|E1|Reported Event|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
1219858|NCT00218634|B3|Baseline|Total|Total of all reporting groups
1219859|NCT00218634|B2|Baseline|ETAU|Enhanced Treatment as Usual
1219860|NCT00218634|B1|Baseline|CBT-AD|Cognitive behavioral therapy for adherence and depression
1219861|NCT00218634|P2|Participant Flow|ETAU|Enhanced Treatment as Usual
1219862|NCT00218634|P1|Participant Flow|CBT-AD|Cognitive behavioral therapy for adherence and depression
1219863|NCT00218634|O2|Outcome|ETAU|Enhanced Treatment as Usual
1219864|NCT00218634|O1|Outcome|CBT-AD|Cognitive behavioral therapy for adherence and depression
1219870|NCT00218634|O1|Outcome|CBT-AD|Cognitive behavioral therapy for adherence and depression
1219871|NCT00218634|O2|Outcome|ETAU|Enhanced treatment as usual
1219872|NCT00218634|O1|Outcome|CBT-AD|Cognitive behavioral therapy for adherence and depression
1219873|NCT00218634|O2|Outcome|ETAU|Enhanced treatment as usual
1219874|NCT00218634|O1|Outcome|CBT-AD|Cognitive behavioral therapy for adherence and depression
1219875|NCT00218634|O2|Outcome|Enhanced Treatment as Usual|Enhanced treatment as usual (ETAU).
1219876|NCT00218634|O1|Outcome|Cognitive Behavioral Therapy for Adherence and Depression|Cognitive behavioral therapy focusing on treating depression and adherence to medication (CBT-AD).
1219877|NCT00218634|O2|Outcome|ETAU|Enhanced treatment as usual
1219878|NCT00218634|O1|Outcome|CBT-AD|Cognitive behavioral therapy for adherence and depression
1219879|NCT00218634|E2|Reported Event|ETAU|Enhanced Treatment as Usual
1219881|NCT00218543|B1|Baseline|Atomoxetine|Initially, atomoxetine was administered at 20 mg/day for three days. This dose was then increased to 40 mg/day for four days. During the second week of the trial, the dose was increased to 60 mg/day and later increased to 80 mg/day at the start of Week 3. Patients were then maintained at 80 mg per day for four weeks. At the beginning of Week 7, patients were maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if there was less than a 50% reduction of ADHD symptoms (as determined by the Adult ADHD Rating Scale; Murphy, 1996) and if the patients were tolerating the medication well. They were then maintained at 80 mg/day or 100 mg/day for the remaining six weeks of the trial. All patients received two capsules to be taken once a day in the morning.
1219882|NCT00218543|P1|Participant Flow|Atomoxetine|Initially, atomoxetine was administered at 20 mg/day for three days. This dose was then increased to 40 mg/day for four days. During the second week of the trial, the dose was increased to 60 mg/day and later increased to 80 mg/day at the start of Week 3. Patients were then maintained at 80 mg per day for four weeks. At the beginning of Week 7, patients were maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if there was less than a 50% reduction of ADHD symptoms (as determined by the Adult ADHD Rating Scale; Murphy, 1996) and if the patients were tolerating the medication well. They were then maintained at 80 mg/day or 100 mg/day for the remaining six weeks of the trial. All patients received two capsules to be taken once a day in the morning.
1219883|NCT00218543|O1|Outcome|Atomoxetine|Initially, atomoxetine was administered at 20 mg/day for three days. This dose was then increased to 40 mg/day for four days. During the second week of the trial, the dose was increased to 60 mg/day and later increased to 80 mg/day at the start of Week 3. Patients were then maintained at 80 mg per day for four weeks. At the beginning of Week 7, patients were maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if there was less than a 50% reduction of ADHD symptoms (as determined by the Adult ADHD Rating Scale; Murphy, 1996) and if the patients were tolerating the medication well. They were then maintained at 80 mg/day or 100 mg/day for the remaining six weeks of the trial. All patients received two capsules to be taken once a day in the morning.
1219884|NCT00218543|O1|Outcome|Atomoxetine|Initially, atomoxetine was administered at 20 mg/day for three days. This dose was then increased to 40 mg/day for four days. During the second week of the trial, the dose was increased to 60 mg/day and later increased to 80 mg/day at the start of Week 3. Patients were then maintained at 80 mg per day for four weeks. At the beginning of Week 7, patients were maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if there was less than a 50% reduction of ADHD symptoms (as determined by the Adult ADHD Rating Scale; Murphy, 1996) and if the patients were tolerating the medication well. They were then maintained at 80 mg/day or 100 mg/day for the remaining six weeks of the trial. All patients received two capsules to be taken once a day in the morning.
1219885|NCT00218543|E1|Reported Event|Atomoxetine|Initially, atomoxetine was administered at 20 mg/day for three days. This dose was then increased to 40 mg/day for four days. During the second week of the trial, the dose was increased to 60 mg/day and later increased to 80 mg/day at the start of Week 3. Patients were then maintained at 80 mg per day for four weeks. At the beginning of Week 7, patients were maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if there was less than a 50% reduction of ADHD symptoms (as determined by the Adult ADHD Rating Scale; Murphy, 1996) and if the patients were tolerating the medication well. They were then maintained at 80 mg/day or 100 mg/day for the remaining six weeks of the trial. All patients received two capsules to be taken once a day in the morning.
1219886|NCT00218465|B3|Baseline|Total|Total of all reporting groups
1219887|NCT00218465|B2|Baseline|Placebo|Placebo group for 5 week relapse prevention trial.
1219888|NCT00218465|B1|Baseline|816 Group|Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.
1219889|NCT00218465|P2|Participant Flow|Placebo|Placebo group for 5 week relapse prevention trial.
1219890|NCT00218465|P1|Participant Flow|816 Group|Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.
1219891|NCT00218465|O2|Outcome|Placebo|Placebo group for 5 week relapse prevention trial.
1219892|NCT00218465|O1|Outcome|816 Group|Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.
1219893|NCT00218465|O2|Outcome|Placebo|Placebo group for 5 week relapse prevention trial.
1219894|NCT00218465|O1|Outcome|816 Group|Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.
1219895|NCT00218465|O2|Outcome|Placebo|Placebo group for 5 week relapse prevention trial.
1219896|NCT00218465|O1|Outcome|816 Group|Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.
1219897|NCT00218465|E2|Reported Event|Placebo|Placebo group for 5 week relapse prevention trial.
1219898|NCT00218465|E1|Reported Event|816 Group|Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.
1219899|NCT00218439|B3|Baseline|Total|Total of all reporting groups
1219900|NCT00218439|B2|Baseline|Paroxetine First 4 Weeks, Then Placebo for 4 Weeks|Paroxetine 10 mg daily for 1 week then increased to 20 mg once daily for remainder of first intervention period, placebo once daily in second intervention period
1219901|NCT00218439|B1|Baseline|Placebo First 4 Weeks, Then Paroxetine for 4 Weeks|Placebo once daily in first intervention period and Paroxetine 10 mg daily for 1 week then increased to 20 mg once daily for remainder of second intervention period
1219902|NCT00218439|P2|Participant Flow|Paroxetine (4 Weeks) the Placebo (4 Weeks)|Paroxetine 10 mg daily for 1 week then increased to 20 mg once daily for remainder of first intervention period, placebo once daily in second intervention period
1219903|NCT00218439|P1|Participant Flow|Placebo (4 Weeks) Then Paroxetine (4 Weeks)|Placebo once daily in first intervention period and Paroxetine 10 mg daily for 1 week then increased to 20 mg once daily for remainder of second intervention period
1219904|NCT00218439|O2|Outcome|After 4 Weeks of Paroxetine|Change in plasma norepinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of paroxetine (1 week of 10 mg once daily followed by 3 weeks of 20 mg once daily)
1219905|NCT00218439|O1|Outcome|After 4 Weeks of Placebo|Change in plasma norepinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of placebo
1219906|NCT00218439|O2|Outcome|After 4 Weeks of Paroxetine|Change in plasma epinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of paroxetine (1 week of 10 mg once daily followed by 3 weeks of 20 mg once daily)
1235831|NCT00132873|O1|Outcome|Xyrem (Sodium Oxybate)|
1219907|NCT00218439|O1|Outcome|After 4 Weeks of Placebo|Change in plasma epinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of placebo
1219908|NCT00218439|O2|Outcome|After 4 Weeks of Paroxetine|Change in heart rate from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of paroxetine (1 week of 10 mg once daily followed by 3 weeks of 20 mg once daily)
1219909|NCT00218439|O1|Outcome|After 4 Weeks of Placebo|Change in heart rate from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of placebo
1219910|NCT00218439|O2|Outcome|After 4 Weeks of Paroxetine|Change in diastolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of paroxetine (1 week of 10 mg once daily followed by 3 weeks of 20 mg once daily)
1219911|NCT00218439|O1|Outcome|After 4 Weeks of Placebo|Change in diastolic blood pressure fom Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of placebo
1219912|NCT00218439|O2|Outcome|After 4 Weeks of Paroxetine|Change in systolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of paroxetine (1 week of 10 mg once daily followed by 3 weeks of 20 mg once daily)
1219913|NCT00218439|O1|Outcome|After 4 Weeks of Placebo|Change in systolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of placebo
1219914|NCT00218439|E2|Reported Event|During 4 Weeks of Paroxetine|Participants received paroxetine 10 mg once daily for 1 week followed by 20 mg once daily for 3 weeks
1219915|NCT00218439|E1|Reported Event|During 4 Weeks of Placebo|Participants receive placebo daily for 4 weeks
1219916|NCT00218335|B5|Baseline|Total|Total of all reporting groups
1219917|NCT00218335|B4|Baseline|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
1219918|NCT00218335|B3|Baseline|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
1219919|NCT00218335|B2|Baseline|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
1219920|NCT00218335|B1|Baseline|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
1219921|NCT00218335|P4|Participant Flow|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
1219922|NCT00218335|P3|Participant Flow|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
1219923|NCT00218335|P2|Participant Flow|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
1219924|NCT00218335|P1|Participant Flow|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
1219925|NCT00218335|O2|Outcome|Control Participants|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
1219926|NCT00218335|O1|Outcome|Intervention Participants|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
1219927|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
1219928|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
1220042|NCT00217724|E1|Reported Event|Oral Glutamine x 4 Days|Oral glutamine 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days.
1220122|NCT00217087|O3|Outcome|Photodynamic Therapy FISH POSITIVE|FISH cytology results were positive prior to therapy
1219929|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
1219930|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
1219931|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
1220124|NCT00217087|O1|Outcome|Endoscopic Mucosal Resection FISH Polysomy Negative|FISH cytology results prior to therapy were negative
1219932|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
1219933|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
1219934|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
1219935|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
1219936|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
1219937|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
1219938|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
1219939|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
1219940|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
1219941|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
1219942|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
1219943|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
1219944|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
1219945|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
1219946|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
1219947|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
1219948|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
1219949|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
1219950|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
1219951|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
1219952|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
1219953|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
1219954|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
1219955|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
1219956|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
1219957|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
1219958|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
1219959|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
1219960|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
1219961|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
1219962|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
1219963|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
1219964|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
1219965|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
1219966|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
1219967|NCT00218335|O2|Outcome|Control Participants|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
1219968|NCT00218335|O1|Outcome|Intervention Participants|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
1219969|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
1219970|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
1219971|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
1219972|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
1219973|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
1219974|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
1219975|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
1220201|NCT00217022|E1|Reported Event|Budesonide|9 mg daily
1219976|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
1219977|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
1219978|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
1220608|NCT00214019|O2|Outcome|Placebo/Salmeterol|Participants on Placebo/Salmeterol arm
1219979|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
1219980|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
1219981|NCT00218335|E4|Reported Event|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
1219982|NCT00218335|E3|Reported Event|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
1219983|NCT00218335|E2|Reported Event|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
1219984|NCT00218335|E1|Reported Event|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
1219985|NCT00218296|B3|Baseline|Total|Total of all reporting groups
1219986|NCT00218296|B2|Baseline|Reduction Group|Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
1219987|NCT00218296|B1|Baseline|Usual Care Group|Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
1219988|NCT00218296|P2|Participant Flow|Reduction Group|Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date. Reduction is facilitated by using nicotine lozenge or ST brand switching resulting in reduced nicotine exposure.
1219989|NCT00218296|P1|Participant Flow|Usual Care Group|Usual Care consisted of setting an immediate quit date and receiving 2 weeks of nicotine patch and behavioral counseling during the 6 week intervention period.
1219990|NCT00218296|O2|Outcome|Reduction Group|Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
1219991|NCT00218296|O1|Outcome|Usual Care Group|Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
1219992|NCT00218296|O2|Outcome|Reduction Group|Reduction group subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date. Reduction is facilitated using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
1219993|NCT00218296|O1|Outcome|Usual Care Group|Usual Care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
1219994|NCT00218296|O2|Outcome|Reduction Group|Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
1219995|NCT00218296|O1|Outcome|Usual Care Group|Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
1219996|NCT00218296|O2|Outcome|Reduction Group|Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
1219997|NCT00218296|O1|Outcome|Usual Care Group|Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
1219998|NCT00218296|O2|Outcome|Reduction Group|Reduction group subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date. Reduction is facilitated using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
1219999|NCT00218296|O1|Outcome|Usual Care Group|Usual Care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
1220000|NCT00218296|O2|Outcome|Reduction Group|Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
1220001|NCT00218296|O1|Outcome|Usual Care Group|Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
1220002|NCT00218296|E2|Reported Event|Reduction Group|Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
1220003|NCT00218296|E1|Reported Event|Usual Care Group|Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
1220004|NCT00218023|B5|Baseline|Total|Total of all reporting groups
1220005|NCT00218023|B4|Baseline|Placebo Plus MI, CM, and CBT|"Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
1220125|NCT00217087|O2|Outcome|Photodynamic Therapy|Patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy.
1220126|NCT00217087|O1|Outcome|Endoscopic Mucosal Resection|Patients will undergo endoscopic mucosal resection at time of endoscopy if indicated.
1220006|NCT00218023|B3|Baseline|Naltrexone HCl Plus MI, CM, and CBT|"Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
1220007|NCT00218023|B2|Baseline|Levodopa/Carbidopa Plus MI, CM, and CBT|"Levodopa–carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
1220008|NCT00218023|B1|Baseline|Modafinil Plus MI, CM, and CBT|"The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
1220009|NCT00218023|P4|Participant Flow|Placebo Plus MI, CM, and CBT|"Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
1220010|NCT00218023|P3|Participant Flow|Naltrexone HCl Plus MI, CM, and CBT|"Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
1220011|NCT00218023|P2|Participant Flow|Levodopa/Carbidopa Plus MI, CM, and CBT|"Levodopa–carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
1220012|NCT00218023|P1|Participant Flow|Modafinil Plus MI, CM, and CBT|"The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
1220013|NCT00218023|O4|Outcome|Placebo Plus MI, CM, and CBT|"Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
1220014|NCT00218023|O3|Outcome|Naltrexone HCl Plus MI, CM, and CBT|"Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
1220015|NCT00218023|O2|Outcome|Levodopa/Carbidopa Plus MI, CM, and CBT|"Levodopa–carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
1220016|NCT00218023|O1|Outcome|Modafinil Plus MI, CM, and CBT|"The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
1220017|NCT00218023|O4|Outcome|Placebo Plus MI, CM, and CBT|"Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
1220018|NCT00218023|O3|Outcome|Naltrexone HCl Plus MI, CM, and CBT|"Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
1220019|NCT00218023|O2|Outcome|Levodopa/Carbidopa Plus MI, CM, and CBT|"Levodopa–carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
1220020|NCT00218023|O1|Outcome|Modafinil Plus MI, CM, and CBT|"The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
1220021|NCT00218023|E4|Reported Event|Placebo Plus MI, CM, and CBT|"Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
1220022|NCT00218023|E3|Reported Event|Naltrexone HCl Plus MI, CM, and CBT|"Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
1220023|NCT00218023|E2|Reported Event|Levodopa/Carbidopa Plus MI, CM, and CBT|"Levodopa–carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
1220024|NCT00218023|E1|Reported Event|Modafinil Plus MI, CM, and CBT|"The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase II.~The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.~Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).~Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II."
1220025|NCT00217971|B3|Baseline|Total|Total of all reporting groups
1220026|NCT00217971|B2|Baseline|Placebo|Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day
1220027|NCT00217971|B1|Baseline|Dronabinol|Dronabinol: 20mg bid for a daily maximum dose of 40mg.
1220028|NCT00217971|P2|Participant Flow|Placebo|Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day
1220029|NCT00217971|P1|Participant Flow|Dronabinol|Dronabinol: 20mg bid for a daily maximum dose of 40mg.
1220030|NCT00217971|O2|Outcome|Placebo|Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day
1220031|NCT00217971|O1|Outcome|Dronabinol|Dronabinol: 20mg bid for a daily maximum dose of 40mg.
1220032|NCT00217971|E2|Reported Event|Placebo|Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day
1220033|NCT00217971|E1|Reported Event|Dronabinol|Dronabinol: 20mg bid for a daily maximum dose of 40mg.
1220034|NCT00217724|B1|Baseline|Entire Study Population|Includes those randomized to Arms 1 and 2 in both course 1 and 2.
1220035|NCT00217724|P2|Participant Flow|Oral Placebo x 4 Days|Oral placebo 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days starting day 2 of course 1 during Paclitaxel treatment.
1220036|NCT00217724|P1|Participant Flow|Oral Glutamine x 4 Days|Oral glutamine 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days starting day 2 of course 1 during Paclitaxel treatment.
1220037|NCT00217724|O2|Outcome|Oral Placebo x 4 Days|Oral placebo 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days.
1220038|NCT00217724|O1|Outcome|Oral Glutamine x 4 Days|Oral glutamine 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days.
1220039|NCT00217724|O2|Outcome|Oral Placebo x 4 Days|Oral placebo 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days.
1220040|NCT00217724|O1|Outcome|Oral Glutamine x 4 Days|Oral glutamine 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days.
1220041|NCT00217724|E2|Reported Event|Oral Placebo x 4 Days|Oral placebo 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days.
1220127|NCT00217087|E2|Reported Event|Photodynamic Therapy|patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy.
1220128|NCT00217087|E1|Reported Event|Endoscopic Mucosl Resection|patients will undergo endoscopic mucosal resection at time of endoscopy if indicated
1220129|NCT00216099|B1|Baseline|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
1220609|NCT00214019|O1|Outcome|Placebo/Placebo|Participants on Placebo/Placebo arm
1220043|NCT00217672|B1|Baseline|Docetaxel + Bevacizumab|"docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.~A total of 104 participants were screened for the study. Twenty six participants did not meet eligibility criteria and 2 withdrew consent.~Seventy six participants were registered to the Treatment Period, 7 to arm A and 69 to arm B. Six out of 7 participants randomized to arm A elected to cross over to arm B once bevacizumab became available. Two out of the 69 participants randomized to arm B were found ineligible and taken off study before receiving treatment. As a result, the efficacy analysis was performed on 67 patients."
1220044|NCT00217672|P2|Participant Flow|Docetaxel|docetaxel: 75 mg/m2 IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
1220045|NCT00217672|P1|Participant Flow|Docetaxel+Bevacizumab|docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
1220046|NCT00217672|O1|Outcome|Docetaxel + Bevacizumab|docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
1220047|NCT00217672|O1|Outcome|Docetaxel + Bevacizumab|docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
1220048|NCT00217672|O1|Outcome|Docetaxel + Bevacizumab|docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
1220049|NCT00217672|E1|Reported Event|Docetaxel and/or Bevacizumab|docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
1220050|NCT00217620|B1|Baseline|Sorafenib (BAY 43-9006)|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
1220051|NCT00217620|P1|Participant Flow|Sorafenib (BAY 43-9006)|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
1220052|NCT00217620|O1|Outcome|Sorafenib (BAY 43-9006)|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
1220053|NCT00217620|O3|Outcome|Vascular Sarcomas|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
1220054|NCT00217620|O2|Outcome|Liposarcoma|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
1220055|NCT00217620|O1|Outcome|Leiomyosarcoma|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
1220056|NCT00217620|O4|Outcome|Total|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
1220057|NCT00217620|O3|Outcome|Vascular Sarcomas|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
1220058|NCT00217620|O2|Outcome|Liposarcoma|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
1220059|NCT00217620|O1|Outcome|Leiomyosarcoma|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
1220060|NCT00217620|E1|Reported Event|Sorafenib (BAY 43-9006)|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
1220061|NCT00217581|B1|Baseline|Docetaxel, Oxaliplatin & Bevacizumab|"Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.~Bevacizumab: Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes."
1220062|NCT00217581|P1|Participant Flow|Docetaxel, Oxaliplatin & Bevacizumab|"Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.~Bevacizumab: Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes."
1220063|NCT00217581|O1|Outcome|Docetaxel, Oxaliplatin & Bevacizumab|"Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.~Bevacizumab: Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes."
1220064|NCT00217581|E1|Reported Event|Docetaxel, Oxaliplatin & Bevacizumab|"Administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; 1st cycle, bevacizumab will be delivered over 90 +/- 15 mins. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 +/- 10 mins. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min +/- 10 mins.~Bevacizumab: Administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 +/- 15 mins. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 +/- 10 mins. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min +/- 10 mins.~Docetaxel: Must be administered 2nd after Bevacizumab then Oxaliplatin.70 mg/m(2), IV over 60 minutes, day 1 of each cycle;"
1220065|NCT00217490|B5|Baseline|Total|Total of all reporting groups
1220066|NCT00217490|B4|Baseline|Physcial Activity-computer|Physical activity counseling delivered by computer only
1220067|NCT00217490|B3|Baseline|Combined|Dietary counseling delivered using computer program and nutritionist
1220068|NCT00217490|B2|Baseline|Counseling Only|Dietary counseling delivered by nutritionist
1220069|NCT00217490|B1|Baseline|Computer Only|Dietary Counseling delivered by interactive computer
1220070|NCT00217490|P4|Participant Flow|Physcial Activity-computer|Physical activity counseling delivered by computer only
1220071|NCT00217490|P3|Participant Flow|Combined|Dietary counseling delivered using computer program and nutritionist
1220072|NCT00217490|P2|Participant Flow|Counseling Only|Dietary counseling delivered by nutritionist
1220073|NCT00217490|P1|Participant Flow|Computer Only|Dietary Counseling delivered by interactive computer
1220074|NCT00217490|O4|Outcome|Physcial Activity-computer|Physical activity counseling delivered by computer only
1220075|NCT00217490|O3|Outcome|Combined|Dietary counseling delivered using computer program and nutritionist
1220076|NCT00217490|O2|Outcome|Counseling Only|Dietary counseling delivered by nutritionist
1220077|NCT00217490|O1|Outcome|Computer Only|Dietary Counseling delivered by interactive computer
1220078|NCT00217490|O4|Outcome|Physcial Activity-computer|"Physical activity counseling delivered by computer only~physical activity counseling via computer: An interactive computer program that addresses increase to physical activity, barriers to change and possible solution to barriers to develop an action plan"
1220079|NCT00217490|O3|Outcome|Combined|"Dietary counseling delivered using computer program and nutritionist~combined computer and nutritionist: An interactive computer program plus one on one nutrition counseling that addresses dietary change, barriers to change and possible solution to barriers to develop an action plan"
1220080|NCT00217490|O2|Outcome|Counseling Only|"Dietary counseling delivered by nutritionist~dietary counseling via nutritionist: A one on one counseling sessions to addresses dietary change, barriers to change and possible solution to barriers to develop an action plan"
1220081|NCT00217490|O1|Outcome|Computer Only|"Dietary Counseling delivered by interactive computer~dietary counseling via computer: An interactive computer program that addresses dietary change, barriers to change and possible solution to barriers to develop an action plan"
1220082|NCT00217490|E4|Reported Event|Physcial Activity-computer|Physical activity counseling delivered by computer only
1220083|NCT00217490|E3|Reported Event|Combined|Dietary counseling delivered using computer program and nutritionist
1220084|NCT00217490|E2|Reported Event|Counseling Only|Dietary counseling delivered by nutritionist
1220085|NCT00217490|E1|Reported Event|Computer Only|Dietary Counseling delivered by interactive computer
1220086|NCT00217464|B1|Baseline|Fulvestrant|"Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity.~fulvestrant: intramuscularly"
1220087|NCT00217464|P1|Participant Flow|Fulvestrant|"Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity.~fulvestrant: intramuscularly"
1220088|NCT00217464|O1|Outcome|Fulvestrant|"Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity.~fulvestrant: intramuscularly"
1220089|NCT00217464|O1|Outcome|Fulvestrant|"Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity.~fulvestrant: intramuscularly"
1220090|NCT00217464|E1|Reported Event|Fulvestrant|"Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity.~fulvestrant: intramuscularly"
1220091|NCT00217438|B3|Baseline|Total|Total of all reporting groups
1220092|NCT00217438|B2|Baseline|Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
1220117|NCT00217087|P2|Participant Flow|Photodynamic Therapy|Patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy.
1220123|NCT00217087|O2|Outcome|Endoscopic Mucosal Resection FISH Positive Positive|FISH cytology results were positive prior to therapy
1220093|NCT00217438|B1|Baseline|Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
1220094|NCT00217438|P2|Participant Flow|Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
1220095|NCT00217438|P1|Participant Flow|Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
1220096|NCT00217438|O2|Outcome|Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
1220097|NCT00217438|O1|Outcome|Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
1220098|NCT00217438|O2|Outcome|Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
1220099|NCT00217438|O1|Outcome|Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
1220100|NCT00217438|E2|Reported Event|Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
1220118|NCT00217087|P1|Participant Flow|Endoscopic Mucosal Resection|Patients will undergo endoscopic mucosal resection at time of endoscopy if indicated.
1220119|NCT00217087|O2|Outcome|Endoscopic Mucosal Resection and Photodynamic Therapy|Patients will have EMR (if indicated at time of endoscopy) followed by photodynamic therapy
1220120|NCT00217087|O1|Outcome|Endoscopic Mucosal Resection|Patients will undergo EMR at time of endoscopy if indicated.
1220101|NCT00217438|E1|Reported Event|Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
1220102|NCT00217425|B1|Baseline|Treatment (A-CHOP Followed by MA)|Patients receive 6-8 cycles of bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP) followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 [max. 2 mg]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.
1220103|NCT00217425|P1|Participant Flow|Treatment (A-CHOP Followed by MA)|Patients receive 6-8 cycles of bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP) followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 [max. 2 mg]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.
1220104|NCT00217425|O1|Outcome|Treatment (A-CHOP Followed by MA)|Patients receive 6-8 cycles of bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP) followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 [max. 2 mg]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.
1220105|NCT00217425|O1|Outcome|Treatment (A-CHOP Followed by MA)|Patients receive 6-8 cycles of bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP) followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 [max. 2 mg]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.
1220106|NCT00217425|O1|Outcome|Treatment (A-CHOP Followed by MA)|Patients receive 6-8 cycles of bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP) followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 [max. 2 mg]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.
1220107|NCT00217425|E1|Reported Event|Treatment (ACHOP Followed by MA)|Adverse events in all treated patients regardless of eligibility.
1220108|NCT00217399|B1|Baseline|Sorafenib and Anastrozole|A single arm of 35 patients with advanced or metastatic breast cancer receiving a combination of sorafenib and anastrozole.
1220109|NCT00217399|P1|Participant Flow|Sorafenib and Anastrozole|A single arm of 35 patients with advanced or metastatic breast cancer receiving a combination of sorafenib and anastrozole.
1220110|NCT00217399|O1|Outcome|Circulating Endothelial Cells|All patients received sorafenib and anastrozole. Blood was drawn prior to beginning treatment and at set time points to analyze for circulating endothelial cells by flow cytometry
1220111|NCT00217399|O1|Outcome|Sorefenib and Anastrozole|All patients receive sorafenib (400mg by mouth twice daily) and anastrazole (1 mg by mouth daily)
1220112|NCT00217399|O1|Outcome|Sorafenib and Anastrozole|All patients receive sorafenib and anastrozole.
1220113|NCT00217399|E1|Reported Event|Sorafenib and Anastrozole|A single arm of 35 patients with advanced or metastatic breast cancer receiving a combination of sorafenib and anastrozole.
1220114|NCT00217087|B3|Baseline|Total|Total of all reporting groups
1220115|NCT00217087|B2|Baseline|Photodynamic Therapy|patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy.
1220116|NCT00217087|B1|Baseline|Endoscopic Mucosl Resection|patients will undergo endoscopic mucosal resection at time of endoscopy if indicated
1220121|NCT00217087|O4|Outcome|Photodynamic Therapy FISH NEGATIVE|FISH cytology results prior to therapy were negative
1220130|NCT00216099|P1|Participant Flow|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
1220131|NCT00216099|O1|Outcome|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
1220132|NCT00216099|O1|Outcome|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
1220133|NCT00216099|O1|Outcome|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
1220134|NCT00216099|O1|Outcome|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
1220135|NCT00216099|O1|Outcome|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
1220136|NCT00216099|O1|Outcome|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
1220137|NCT00216099|O1|Outcome|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
1220138|NCT00216099|O1|Outcome|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
1220139|NCT00216099|E1|Reported Event|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
1220140|NCT00216086|B1|Baseline|Single Group Assignment|"Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles *For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Capecitabine: Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles~*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Irinotecan: Irinotecan 200 mg/m2 IV, day 1~EUS: biopsy per EUS~Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles~Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4~Surgery: Surgery within 8 weeks following chemoradiotherapy~Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion"
1220141|NCT00216086|P1|Participant Flow|Single Group Assignment|"Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles *For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Capecitabine: Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles~*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Irinotecan: Irinotecan 200 mg/m2 IV, day 1~EUS: biopsy per EUS~Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles~Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4~Surgery: Surgery within 8 weeks following chemoradiotherapy~Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion"
1220142|NCT00216086|O1|Outcome|Single Group Assignment|"Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles *For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Capecitabine: Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles~*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Irinotecan: Irinotecan 200 mg/m2 IV, day 1~EUS: biopsy per EUS~Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles~Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4~Surgery: Surgery within 8 weeks following chemoradiotherapy~Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion"
1220143|NCT00216086|O1|Outcome|Single Group Assignment|"Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles *For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Capecitabine: Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles~*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Irinotecan: Irinotecan 200 mg/m2 IV, day 1~EUS: biopsy per EUS~Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles~Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4~Surgery: Surgery within 8 weeks following chemoradiotherapy~Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion"
1220173|NCT00215943|P2|Participant Flow|Active Comparator: Thalidomide and Dexamethasone Treatment|Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
1220202|NCT00216736|B3|Baseline|Total|Total of all reporting groups
1220203|NCT00216736|B2|Baseline|Dexamethasone|
1220204|NCT00216736|B1|Baseline|Placebo|
1220205|NCT00216736|P2|Participant Flow|Dexamethasone|
1220206|NCT00216736|P1|Participant Flow|Placebo|
1220144|NCT00216086|O1|Outcome|Single Group Assignment|"Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles *For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Capecitabine: Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles~*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Irinotecan: Irinotecan 200 mg/m2 IV, day 1~EUS: biopsy per EUS~Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles~Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4~Surgery: Surgery within 8 weeks following chemoradiotherapy~Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion"
1220636|NCT00210639|P2|Participant Flow|Comparator|Participants who received comparator in the previous studies.
1220145|NCT00216086|O1|Outcome|Single Group Assignment|"Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles *For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Capecitabine: Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles~*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Irinotecan: Irinotecan 200 mg/m2 IV, day 1~EUS: biopsy per EUS~Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles~Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4~Surgery: Surgery within 8 weeks following chemoradiotherapy~Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion"
1220146|NCT00216086|E1|Reported Event|Single Group Assignment|"Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles *For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Capecitabine: Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles~*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Irinotecan: Irinotecan 200 mg/m2 IV, day 1~EUS: biopsy per EUS~Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles~Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4~Surgery: Surgery within 8 weeks following chemoradiotherapy~Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion"
1220147|NCT00216060|B3|Baseline|Total|Total of all reporting groups
1220148|NCT00216060|B2|Baseline|Placebo|daily oral placebo combined with androgen deprivation
1220149|NCT00216060|B1|Baseline|Risedronate|Daily oral risedronate combined with androgen deprivation
1220150|NCT00216060|P2|Participant Flow|Placebo|daily oral placebo combined with androgen deprivation
1220151|NCT00216060|P1|Participant Flow|Risedronate|Daily oral risedronate combined with androgen deprivation
1220152|NCT00216060|O2|Outcome|Placebo Arm|"daily oral placebo combined with androgen deprivation~Placebo: Daily oral placebo combined with androgen deprivation"
1220153|NCT00216060|O1|Outcome|Risedronate Arm|"Daily oral risedronate combined with androgen deprivation~Risedronate: Daily oral risedronate combined with androgen deprivation"
1220154|NCT00216060|O2|Outcome|Placebo Arm|"daily oral placebo combined with androgen deprivation~Placebo: Daily oral placebo combined with androgen deprivation"
1220155|NCT00216060|O1|Outcome|Risedronate Arm|"Daily oral risedronate combined with androgen deprivation~Risedronate: Daily oral risedronate combined with androgen deprivation"
1220156|NCT00216060|O2|Outcome|Placebo Arm|"daily oral placebo combined with androgen deprivation~Placebo: Daily oral placebo combined with androgen deprivation"
1220157|NCT00216060|O1|Outcome|Risedronate Arm|"Daily oral risedronate combined with androgen deprivation~Risedronate: Daily oral risedronate combined with androgen deprivation"
1220158|NCT00216060|O2|Outcome|Placebo|daily oral placebo combined with androgen deprivation
1220159|NCT00216060|O1|Outcome|Risedronate|Daily oral risedronate combined with androgen deprivation
1220160|NCT00216060|O2|Outcome|Placebo Arm|"daily oral placebo combined with androgen deprivation~Placebo: Daily oral placebo combined with androgen deprivation"
1220161|NCT00216060|O1|Outcome|Risedronate Arm|"Daily oral risedronate combined with androgen deprivation~Risedronate: Daily oral risedronate combined with androgen deprivation"
1220162|NCT00216060|O2|Outcome|Placebo Arm|"daily oral placebo combined with androgen deprivation~Placebo: Daily oral placebo combined with androgen deprivation"
1220163|NCT00216060|O1|Outcome|Risedronate Arm|"Daily oral risedronate combined with androgen deprivation~Risedronate: Daily oral risedronate combined with androgen deprivation"
1220164|NCT00216060|O2|Outcome|Placebo Arm|"daily oral placebo combined with androgen deprivation~Placebo: Daily oral placebo combined with androgen deprivation"
1220165|NCT00216060|O1|Outcome|Risedronate Arm|"Daily oral risedronate combined with androgen deprivation~Risedronate: Daily oral risedronate combined with androgen deprivation"
1220166|NCT00216060|O2|Outcome|Placebo Arm|"daily oral placebo combined with androgen deprivation~Placebo: Daily oral placebo combined with androgen deprivation"
1220167|NCT00216060|O1|Outcome|Risedronate Arm|"Daily oral risedronate combined with androgen deprivation~Risedronate: Daily oral risedronate combined with androgen deprivation"
1220168|NCT00216060|E2|Reported Event|Risedronate|Daily oral risedronate combined with androgen deprivation
1220169|NCT00216060|E1|Reported Event|Placebo|daily oral placebo combined with androgen deprivation
1220170|NCT00215943|B3|Baseline|Total|Total of all reporting groups
1220171|NCT00215943|B2|Baseline|Active Comparator: Thalidomide and Dexamethasone Treatment|Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
1220172|NCT00215943|B1|Baseline|Active Comparator: VAD Treatment|"VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one cycle of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle."
1220194|NCT00217022|P2|Participant Flow|Placebo|three tablets daily
1220195|NCT00217022|P1|Participant Flow|Budesonide|9 mg daily
1220174|NCT00215943|P1|Participant Flow|Active Comparator: VAD Treatment|"VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one cycle of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle."
1220175|NCT00215943|O2|Outcome|Active Comparator: Thalidomide and Dexamethasone Treatment|Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
1220176|NCT00215943|O1|Outcome|Active Comparator: VAD Treatment|"VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one cycle of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle."
1220177|NCT00215943|O2|Outcome|Active Comparator: Thalidomide and Dexamethasone Treatment|Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
1220178|NCT00215943|O1|Outcome|Active Comparator: VAD Treatment|"VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one cycle of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle."
1220179|NCT00215943|O2|Outcome|Active Comparator: Thalidomide and Dexamethasone Treatment|Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
1220180|NCT00215943|O1|Outcome|Active Comparator: VAD Treatment|"VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one cycle of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle."
1220181|NCT00215943|O2|Outcome|Active Comparator: Thalidomide and Dexamethasone Treatment|Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
1220182|NCT00215943|O1|Outcome|Active Comparator: VAD Treatment|"VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one cycle of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle."
1220183|NCT00215943|E2|Reported Event|Active Comparator: Thalidomide and Dexamethasone Treatment|Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
1220184|NCT00215943|E1|Reported Event|Active Comparator: VAD Treatment|"VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one cycle of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle."
1220185|NCT00215930|B1|Baseline|Double Agent Chemotherapy|Molecular Analysis-Directed Chemotherapy Assignment based on gene expression.
1220186|NCT00215930|P1|Participant Flow|Double Agent Chemotherapy|Molecular Analysis-Directed Chemotherapy Assignment based on gene expression of Ribonucleotide reductase subunit 1(ERCC1) and Excision repair cross-complementing group 1 gene (RRM1). GD group was treated with gemcitabine (1,250 mg/m2 on days 1 and 8) and docetaxel (40 mg/m2 on days 1 and 8) every 21 days. DC group was treated with docetaxel (75 mg/m2 on day 1) and carboplatin (AUC 5 on day 1) every 21 days. DV group was treated with vinorelbine (45mg/m2ondays 1 and 15) and docetaxel (60mg/m2ondays 1 and 15) every 28 days. GC group was treated with gemcitabine (1,250 mg/m2 on days 1 and 8) and carboplatin (area under the concentration-time curve [AUC] of 5 on day 1) every 21 days.
1220187|NCT00215930|O1|Outcome|Double Agent Chemotherapy|Molecular Analysis-Directed Chemotherapy Assignment based on gene expression.
1220188|NCT00215930|O1|Outcome|Double Agent Chemotherapy|Molecular Analysis-Directed Chemotherapy Assignment based on gene expression.
1220189|NCT00215930|O1|Outcome|Double Agent Chemotherapy|Molecular Analysis-Directed Chemotherapy Assignment based on gene expression. Complete Response (CR): disappearance of all target lesions. Partial Response (PR): at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive Disease (PD): at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started.
1220190|NCT00215930|E1|Reported Event|Double Agent Chemotherapy|Molecular Analysis-Directed Chemotherapy Assignment based on gene expression.
1220191|NCT00217022|B3|Baseline|Total|Total of all reporting groups
1220192|NCT00217022|B2|Baseline|Placebo|three tablets daily
1220193|NCT00217022|B1|Baseline|Budesonide|9 mg daily
1220207|NCT00216736|O2|Outcome|Dexamethasone|
1220208|NCT00216736|O1|Outcome|Placebo|
1220209|NCT00216736|O2|Outcome|Dexamethasone|
1220210|NCT00216736|O1|Outcome|Placebo|
1220211|NCT00216736|O2|Outcome|Dexamethasone|
1220212|NCT00216736|O1|Outcome|Placebo|
1220213|NCT00216736|O2|Outcome|Dexamethasone|
1220214|NCT00216736|O1|Outcome|Placebo|
1220215|NCT00216736|E2|Reported Event|Dexamethasone|
1220216|NCT00216736|E1|Reported Event|Placebo|
1220217|NCT00216671|B3|Baseline|Total|Total of all reporting groups
1220443|NCT00215150|O2|Outcome|Randomization Phase for Ziprasidone Group|The group of subjects randomized to receive Ziprasidone for the second 8 weeks
1220218|NCT00216671|B2|Baseline|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
1220219|NCT00216671|B1|Baseline|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.
1220220|NCT00216671|P2|Participant Flow|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days.
1220221|NCT00216671|P1|Participant Flow|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days.
1220222|NCT00216671|O2|Outcome|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
1220223|NCT00216671|O1|Outcome|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.
1220224|NCT00216671|O2|Outcome|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
1220225|NCT00216671|O1|Outcome|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.
1220226|NCT00216671|O2|Outcome|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
1220227|NCT00216671|O1|Outcome|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.
1220228|NCT00216671|O2|Outcome|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
1220229|NCT00216671|O1|Outcome|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.
1220230|NCT00216671|O2|Outcome|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
1220231|NCT00216671|O1|Outcome|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.
1220482|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
1220232|NCT00216671|O2|Outcome|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
1220444|NCT00215150|O1|Outcome|Open Label Phase|The open label treatment phase for the first 8 weeks
1220445|NCT00215150|E3|Reported Event|Randomization Phase for Placebo|The second phase of treatment with subjects randomized to placebo augmentation.
1220233|NCT00216671|O1|Outcome|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.
1220234|NCT00216671|E2|Reported Event|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days.
1220235|NCT00216671|E1|Reported Event|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days.
1220236|NCT00216476|B3|Baseline|Total|Total of all reporting groups
1220237|NCT00216476|B2|Baseline|Quetiapine|oral, target dose of 300-400 mg b.i.d. or t.i.d.
1220238|NCT00216476|B1|Baseline|Risperidone LAI|intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
1220239|NCT00216476|P3|Participant Flow|Aripiprazole|oral Aripiprazole, recommended maintenance dose of 10-30 mg once daily (q.d.)
1220240|NCT00216476|P2|Participant Flow|Quetiapine|oral Quetiapine, target dose of 300-400 mg twice daily (b.i.d.) or three times daily (t.i.d.)
1220241|NCT00216476|P1|Participant Flow|Risperidone LAI|Risperidone Long Acting Injectable (LAI) intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
1220242|NCT00216476|O3|Outcome|Aripiprazole|oral Aripiprazole, recommended maintenance dose of 10-30 mg once daily (q.d.)
1220243|NCT00216476|O2|Outcome|Quetiapine|oral Quetiapine, target dose of 300-400 mg twice daily (b.i.d.) or three times daily (t.i.d.)
1220244|NCT00216476|O1|Outcome|Risperidone LAI|Risperidone Long Acting Injectable (LAI) intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
1220245|NCT00216476|O3|Outcome|Aripiprazole|oral Aripiprazole, recommended maintenance dose of 10-30 mg once daily (q.d.)
1220246|NCT00216476|O2|Outcome|Quetiapine|oral Quetiapine, target dose of 300-400 mg twice daily (b.i.d.) or three times daily (t.i.d.)
1220247|NCT00216476|O1|Outcome|Risperidone LAI|Risperidone Long Acting Injectable (LAI) intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
1220248|NCT00216476|O3|Outcome|Aripiprazole|oral Aripiprazole, recommended maintenance dose of 10-30 mg once daily (q.d.)
1220249|NCT00216476|O2|Outcome|Quetiapine|oral Quetiapine, target dose of 300-400 mg twice daily (b.i.d.) or three times daily (t.i.d.)
1220250|NCT00216476|O1|Outcome|Risperidone LAI|Risperidone Long Acting Injectable (LAI) intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
1220251|NCT00216476|O1|Outcome|Aripiprazole|oral, recommended maintenance dose of 10-30 mg q.d.
1220252|NCT00216476|O2|Outcome|Quetiapine|oral, target dose of 300-400 mg b.i.d. or t.i.d.
1220253|NCT00216476|O1|Outcome|Risperidone LAI|intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
1220254|NCT00216476|E3|Reported Event|Aripiprazole|oral Aripiprazole, recommended maintenance dose of 10-30 mg once daily (q.d.)
1220255|NCT00216476|E2|Reported Event|Quetiapine|oral Quetiapine, target dose of 300-400 mg twice daily (b.i.d.) or three times daily (t.i.d.)
1220256|NCT00216476|E1|Reported Event|Risperidone LAI|Risperidone Long Acting Injectable (LAI) intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
1220257|NCT00216320|B4|Baseline|Total|Total of all reporting groups
1220258|NCT00216320|B3|Baseline|Arm 3: No Crossover|Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
1220259|NCT00216320|B2|Baseline|Arm 2: Ankle Foot Orthosis|Subjects started with the AFO and crossed over to the WalkAide after six weeks.
1220260|NCT00216320|B1|Baseline|Arm 1: WalkAide|Subjects started with the WalkAide and crossed over to the AFO after six weeks.
1220261|NCT00216320|P3|Participant Flow|Arm 3: No Crossover|Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
1220262|NCT00216320|P2|Participant Flow|Arm 2: Ankle Foot Orthosis|Subjects started with the AFO and crossed over to the WalkAide after six weeks.
1220263|NCT00216320|P1|Participant Flow|Arm 1: WalkAide|Subjects started with the WalkAide and crossed over to the AFO after six weeks.
1220264|NCT00216320|O3|Outcome|Arm 3: No Crossover|Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
1220265|NCT00216320|O2|Outcome|Arm 2: Ankle Foot Orthosis|Subjects started with the AFO and crossed over to the WalkAide after six weeks.
1220266|NCT00216320|O1|Outcome|Arm 1: WalkAide|Subjects started with the WalkAide and crossed over to the AFO after six weeks.
1220267|NCT00216320|O3|Outcome|Arm 3: No Crossover|Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
1220268|NCT00216320|O2|Outcome|Arm 2: Ankle Foot Orthosis|Subjects started with the AFO and crossed over to the WalkAide after six weeks.
1220269|NCT00216320|O1|Outcome|Arm 1: WalkAide|Subjects started with the WalkAide and crossed over to the AFO after six weeks.
1220270|NCT00216320|O3|Outcome|Arm 3: No Crossover|Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
1220271|NCT00216320|O2|Outcome|Arm 2: Ankle Foot Orthosis|Subjects started with the AFO and crossed over to the WalkAide after six weeks.
1220272|NCT00216320|O1|Outcome|Arm 1: WalkAide|Subjects started with the WalkAide and crossed over to the AFO after six weeks.
1220273|NCT00216320|O1|Outcome|Subjects Who Used Both WA and AFO|Subjects in arm 1 (wore WalkAide for 6 weeks followed by AFO for 6 weeks) and arm 2 (wore AFO for 6 weeks followed by WalkAide for 6 weeks)were given the option of continuing for 12 more weeks with their choice of device
1220274|NCT00216320|E3|Reported Event|Arm 3|All subjects used AFO for all 12 weeks of study.
1220275|NCT00216320|E2|Reported Event|Arm 2|All subjects used AFO for the first 6 weeks and WalkAide for the second six weeks.
1220276|NCT00216320|E1|Reported Event|Arm 1|All subjects used WalkAide for the first 6 weeks and AFO for the second six weeks.
1220446|NCT00215150|E2|Reported Event|Randomization Phase for Ziprasidone|The second phase of treatment with subjects randomized to ziprasidone augmentation.
1220447|NCT00215150|E1|Reported Event|Open Label Phase|The first 8 weeks of treatment on sertraline
1220277|NCT00216203|B1|Baseline|Pemetrexed + Cetuximab|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.~Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles~Cetuximab: Cetuximab 400 mg/m2, week 1, day 1~Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
1220278|NCT00216203|P1|Participant Flow|Pemetrexed + Cetuximab|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.~Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles~Cetuximab: Cetuximab 400 mg/m2, week 1, day 1~Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
1220279|NCT00216203|O1|Outcome|Pemetrexed + Cetuximab|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.~Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles~Cetuximab: Cetuximab 400 mg/m2, week 1, day 1~Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
1220280|NCT00216203|O1|Outcome|Pemetrexed + Cetuximab|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.~Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles~Cetuximab: Cetuximab 400 mg/m2, week 1, day 1~Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
1220281|NCT00216203|O1|Outcome|Pemetrexed + Cetuximab|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.~Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles~Cetuximab: Cetuximab 400 mg/m2, week 1, day 1~Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
1220282|NCT00216203|O1|Outcome|Pemetrexed + Cetuximab|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.~Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles~Cetuximab: Cetuximab 400 mg/m2, week 1, day 1~Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
1220283|NCT00216203|O1|Outcome|Investigational Treatment|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.~Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles~Cetuximab: Cetuximab 400 mg/m2, week 1, day 1~Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
1220284|NCT00216203|E1|Reported Event|Pemetrexed + Cetuximab|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.~Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles~Cetuximab: Cetuximab 400 mg/m2, week 1, day 1~Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
1220285|NCT00216125|B1|Baseline|Pre-Randomization|"Prior to randomization patients received Cisplatin 50 mg/m^2 days 1,8,29,36 + Etoposide 50 mg/m^2 days 1-5, 29-33 + Radiation 5940 cGy (180 cGy/day). Patients with CR, PR or SD with manageable toxicity were randomized to either Docetaxel arm or Observation only arm.~Cisplatin: Cisplatin 50 mg/m2 day 1, 8, 29, 36~Etoposide: Etoposide 50 mg/m2, days 1-5, 29-33~Radiation: Radiation 5940 cGy (180 cGy/day)"
1220286|NCT00216125|P3|Participant Flow|Observation Only|Patients were followed for Observation.
1220287|NCT00216125|P2|Participant Flow|Consolidation Docetaxel|"Docetaxel 75 mg/m^2 q3wk X 3 cycles.~Docetaxel: docetaxel 75mg/m2 q3wk x 3 cycles"
1220288|NCT00216125|P1|Participant Flow|Pre-Randomization|"Prior to randomization patients received Cisplatin 50 mg/m^2 days 1,8,29,36 + Etoposide 50 mg/m^2 days 1-5, 29-33 + Radiation 5940 cGy (180 cGy/day). Patients with CR, PR or SD with manageable toxicity were randomized to either Docetaxel arm or Observation only arm.~Cisplatin: Cisplatin 50 mg/m2 day 1, 8, 29, 36~Etoposide: Etoposide 50 mg/m2, days 1-5, 29-33~Radiation: Radiation 5940 cGy (180 cGy/day)"
1220289|NCT00216125|O2|Outcome|Observation Only|Patients were followed for Observation.
1220290|NCT00216125|O1|Outcome|Consolidation Docetaxel|"Docetaxel 75 mg/m^2 q3wk X 3 cycles.~Docetaxel: docetaxel 75mg/m2 q3wk x 3 cycles"
1220291|NCT00216125|O2|Outcome|Observation Only|Patients were followed for Observation.
1220292|NCT00216125|O1|Outcome|Consolidation Docetaxel|"Docetaxel 75 mg/m^2 q3wk X 3 cycles.~Docetaxel: docetaxel 75mg/m2 q3wk x 3 cycles"
1220293|NCT00216125|E3|Reported Event|Observation Only|Patients were followed for Observation.
1220294|NCT00216125|E2|Reported Event|Consolidation Docetaxel|"Docetaxel 75 mg/m^2 q3wk X 3 cycles.~Docetaxel: docetaxel 75mg/m2 q3wk x 3 cycles"
1220295|NCT00216125|E1|Reported Event|Pre-Randomization|"Prior to randomization patients received Cisplatin 50 mg/m^2 days 1,8,29,36 + Etoposide 50 mg/m^2 days 1-5, 29-33 + Radiation 5940 cGy (180 cGy/day). Patients with CR, PR or SD with manageable toxicity were randomized to either Docetaxel arm or Observation only arm.~Cisplatin: Cisplatin 50 mg/m2 day 1, 8, 29, 36~Etoposide: Etoposide 50 mg/m2, days 1-5, 29-33~Radiation: Radiation 5940 cGy (180 cGy/day)~Adverse events reported in this arm consist only of participants that were not randomized into the Consolidation Docetaxel or Observation Only arms."
1220296|NCT00215787|B1|Baseline|Lansoprazole|Lansoprazole 30mg BID for one year
1220297|NCT00215787|P1|Participant Flow|Lansoprazole|Lansoprazole 30mg BID for one year
1220298|NCT00215787|O1|Outcome|Lansoprazole|Lansoprazole 30mg BID for one year
1220299|NCT00215787|E1|Reported Event|Lansoprazole|Lansoprazole 30mg BID for one year
1220300|NCT00215683|B4|Baseline|Total|Total of all reporting groups
1220301|NCT00215683|B3|Baseline|Degarelix 160 mg|Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
1220302|NCT00215683|B2|Baseline|Degarelix 120 mg|Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
1220303|NCT00215683|B1|Baseline|Degarelix 80 mg|Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
1220304|NCT00215683|P3|Participant Flow|Degarelix 160 mg|Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
1220305|NCT00215683|P2|Participant Flow|Degarelix 120 mg|Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
1220306|NCT00215683|P1|Participant Flow|Degarelix 80 mg|Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
1220307|NCT00215683|O3|Outcome|Degarelix 160 mg|Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
1220308|NCT00215683|O2|Outcome|Degarelix 120 mg|Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
1220309|NCT00215683|O1|Outcome|Degarelix 80 mg|Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
1220310|NCT00215683|O3|Outcome|Degarelix 160 mg|Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
1220311|NCT00215683|O2|Outcome|Degarelix 120 mg|Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
1220312|NCT00215683|O1|Outcome|Degarelix 80 mg|Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
1220313|NCT00215683|E3|Reported Event|Degarelix 160 mg|Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
1220314|NCT00215683|E2|Reported Event|Degarelix 120 mg|Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
1220315|NCT00215683|E1|Reported Event|Degarelix 80 mg|Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
1220316|NCT00215657|B9|Baseline|Total|Total of all reporting groups
1220317|NCT00215657|B8|Baseline|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
1220318|NCT00215657|B7|Baseline|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
1220319|NCT00215657|B6|Baseline|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
1220320|NCT00215657|B5|Baseline|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
1220321|NCT00215657|B4|Baseline|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
1220322|NCT00215657|B3|Baseline|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
1220323|NCT00215657|B2|Baseline|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
1220324|NCT00215657|B1|Baseline|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
1220325|NCT00215657|P8|Participant Flow|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
1220326|NCT00215657|P7|Participant Flow|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
1220327|NCT00215657|P6|Participant Flow|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
1220328|NCT00215657|P5|Participant Flow|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
1220329|NCT00215657|P4|Participant Flow|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
1220330|NCT00215657|P3|Participant Flow|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
1220331|NCT00215657|P2|Participant Flow|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
1220332|NCT00215657|P1|Participant Flow|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
1220333|NCT00215657|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
1220334|NCT00215657|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
1220335|NCT00215657|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
1220336|NCT00215657|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
1220337|NCT00215657|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
1220338|NCT00215657|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
1220339|NCT00215657|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
1220340|NCT00215657|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
1220341|NCT00215657|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
1220342|NCT00215657|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
1220343|NCT00215657|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
1220344|NCT00215657|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
1220345|NCT00215657|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
1220346|NCT00215657|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
1220347|NCT00215657|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
1220348|NCT00215657|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
1220349|NCT00215657|E8|Reported Event|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
1220350|NCT00215657|E7|Reported Event|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
1220351|NCT00215657|E6|Reported Event|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
1220352|NCT00215657|E5|Reported Event|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
1220353|NCT00215657|E4|Reported Event|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
1220354|NCT00215657|E3|Reported Event|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
1220355|NCT00215657|E2|Reported Event|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
1220356|NCT00215657|E1|Reported Event|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
1220357|NCT00215553|B8|Baseline|Total|Total of all reporting groups
1220483|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
1220358|NCT00215553|B7|Baseline|B.3 SoC|Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
1220638|NCT00210639|O2|Outcome|Comparator|Participants who received comparator in the previous studies.
1220359|NCT00215553|B6|Baseline|B.2 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
1220360|NCT00215553|B5|Baseline|B.1 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
1220361|NCT00215553|B4|Baseline|A.4 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
1220362|NCT00215553|B3|Baseline|A.3 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
1220363|NCT00215553|B2|Baseline|A.2 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
1220364|NCT00215553|B1|Baseline|A.1 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
1220365|NCT00215553|P7|Participant Flow|B.3 SoC|Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
1220366|NCT00215553|P6|Participant Flow|B.2 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
1220367|NCT00215553|P5|Participant Flow|B.1 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
1220368|NCT00215553|P4|Participant Flow|A.4 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
1220369|NCT00215553|P3|Participant Flow|A.3 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
1220370|NCT00215553|P2|Participant Flow|A.2 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
1220371|NCT00215553|P1|Participant Flow|A.1 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
1220372|NCT00215553|O7|Outcome|B.3 SoC|Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
1220373|NCT00215553|O6|Outcome|B.2 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
1220374|NCT00215553|O5|Outcome|B.1 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
1220375|NCT00215553|O4|Outcome|A.4 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
1220376|NCT00215553|O3|Outcome|A.3 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
1220377|NCT00215553|O2|Outcome|A.2 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
1220378|NCT00215553|O1|Outcome|A.1 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
1220379|NCT00215553|O7|Outcome|B.3 SoC|Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
1220380|NCT00215553|O6|Outcome|B.2 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
1220381|NCT00215553|O5|Outcome|B.1 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
1220382|NCT00215553|O4|Outcome|A.4 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
1220383|NCT00215553|O3|Outcome|A.3 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
1220384|NCT00215553|O2|Outcome|A.2 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
1220385|NCT00215553|O1|Outcome|A.1 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
1220386|NCT00215553|O7|Outcome|B.3 SoC|Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
1220387|NCT00215553|O6|Outcome|B.2 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
1220484|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
1220388|NCT00215553|O5|Outcome|B.1 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
1220389|NCT00215553|O4|Outcome|A.4 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
1220390|NCT00215553|O3|Outcome|A.3 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
1220391|NCT00215553|O2|Outcome|A.2 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
1220392|NCT00215553|O1|Outcome|A.1 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
1220393|NCT00215553|E7|Reported Event|B.3 SoC|Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
1220394|NCT00215553|E6|Reported Event|B.2 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
1220395|NCT00215553|E5|Reported Event|B.1 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
1220396|NCT00215553|E4|Reported Event|A.4 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
1220397|NCT00215553|E3|Reported Event|A.3 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
1220398|NCT00215553|E2|Reported Event|A.2 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
1220399|NCT00215553|E1|Reported Event|A.1 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
1220400|NCT00215540|B4|Baseline|Total|Total of all reporting groups
1220401|NCT00215540|B3|Baseline|Placebo|Sham air using 3.0 mL/kg volume of air
1220402|NCT00215540|B2|Baseline|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
1220403|NCT00215540|B1|Baseline|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
1220404|NCT00215540|P3|Participant Flow|Placebo|Sham air using 3.0 mL/kg volume of air
1220405|NCT00215540|P2|Participant Flow|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
1220406|NCT00215540|P1|Participant Flow|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
1220407|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
1220408|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
1220409|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
1220410|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
1220411|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
1220412|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
1220413|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
1220414|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
1220415|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
1220416|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
1220417|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
1220418|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
1220419|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
1220420|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
1220421|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
1220422|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
1220423|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
1220424|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
1220425|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
1220426|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
1220427|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
1220428|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
1220429|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
1220430|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
1220431|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
1220432|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
1220433|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
1220434|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
1220435|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
1220436|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
1220437|NCT00215540|E3|Reported Event|Placebo|Sham air using 3.0 mL/kg volume of air
1220438|NCT00215540|E2|Reported Event|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
1220439|NCT00215540|E1|Reported Event|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
1220440|NCT00215150|B1|Baseline|Study Treatment|8 weeks of open label treatment with sertraline followed by 8 weeks of treatment with ziprasidone/placebo for qualifying subjects
1220441|NCT00215150|P1|Participant Flow|Open Label Treatment|8 weeks of open label treatment with sertraline (50-200mg/day)followed by 8 weeks of randomized, Double Blind (DB), placebo-controlled augmentation with ziprasidone (40-160mg/day)for qualifying subjects.
1220442|NCT00215150|O3|Outcome|Randomization Phase for Placebo Group|The group of subjects randomized to receive placebo for the second 8 weeks
1220448|NCT00215137|B1|Baseline|Open Label Escitalopram|Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects.
1220449|NCT00215137|P3|Participant Flow|Randomization Escitalopram|Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).
1220450|NCT00215137|P2|Participant Flow|Randomization Placebo|Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).
1220451|NCT00215137|P1|Participant Flow|Open Label Escitalopram|Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects.
1220452|NCT00215137|O3|Outcome|Randomization Escitalopram|Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).Data presented is based on an intent to treat (ITT), last observation carried forward (LOCF) from beginning of the study phase sample.
1220453|NCT00215137|O2|Outcome|Randomization Placebo|Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).Data presented is based on an intent to treat (ITT), last observation carried forward (LOCF) from post beginning of the study phase sample.
1220454|NCT00215137|O1|Outcome|Open Label Escitalopram|Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects.Data presented is based on an intent to treat (ITT), last observation carried forward (LOCF) from post baseline sample.
1220455|NCT00215137|E3|Reported Event|Randomization Escitalopram|Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).
1220456|NCT00215137|E2|Reported Event|Randomization Placebo|Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).
1220457|NCT00215137|E1|Reported Event|Open Label Escitalopram|Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects.
1220458|NCT00214903|B5|Baseline|Total|Total of all reporting groups
1220459|NCT00214903|B4|Baseline|Non-oral HRT|Users of non-oral HRT preparations
1220460|NCT00214903|B3|Baseline|ooHRT|Users of oral but not continuous combined HRT preparations
1220461|NCT00214903|B2|Baseline|ooccHRT|Users of other oral continuous combined HRT preparations containing other progestogens
1220462|NCT00214903|B1|Baseline|DRSP/E2|Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol
1220463|NCT00214903|P4|Participant Flow|Non-oral HRT|Users of non-oral HRT preparations
1220464|NCT00214903|P3|Participant Flow|ooHRT|Users of oral but not continuous combined HRT preparations
1220465|NCT00214903|P2|Participant Flow|ooccHRT|Users of other oral continuous combined HRT preparations containing other progestogens
1220466|NCT00214903|P1|Participant Flow|DRSP/E2|Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol
1220467|NCT00214903|O4|Outcome|Non-oral HRT|Users of non-oral HRT preparations
1220468|NCT00214903|O3|Outcome|ooHRT|Users of oral but not continuous combined HRT preparations
1220469|NCT00214903|O2|Outcome|ooccHRT|Users of other oral continuous combined HRT preparations containing other progestogens
1220470|NCT00214903|O1|Outcome|DRSP/E2|Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol
1220471|NCT00214903|O4|Outcome|Non-oral HRT|Users of non-oral HRT preparations
1220472|NCT00214903|O3|Outcome|ooHRT|Users of oral but not continuous combined HRT preparations
1220473|NCT00214903|O2|Outcome|ooccHRT|Users of other oral continuous combined HRT preparations containing other progestogens
1220474|NCT00214903|O1|Outcome|DRSP/E2|Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol
1220475|NCT00214903|E4|Reported Event|Non-oral HRT|Users of non-oral HRT preparations
1220476|NCT00214903|E3|Reported Event|ooHRT|Users of oral but not continuous combined HRT preparations
1220477|NCT00214903|E2|Reported Event|ooccHRT|Users of other oral continuous combined HRT preparations containing other progestogens
1220478|NCT00214903|E1|Reported Event|DRSP/E2|Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol
1220479|NCT00214786|B1|Baseline|Islet Cell|Patients with allogeneic islet cell transplantation
1220480|NCT00214786|P1|Participant Flow|Islet Cell Transplantation|Patients who received islet cell transplantation. The recipients will be given islet cell preparation with more than 4000 Islet Equivalent (IE)/kg for multiple times up to 3 infusions.
1220481|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
1220485|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
1220486|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
1220487|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
1220488|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
1220489|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
1220490|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
1220491|NCT00214786|E1|Reported Event|Islet Cell|Patients with allogeneic islet cell transplantation
1220492|NCT00214539|B3|Baseline|Total|Total of all reporting groups
1220637|NCT00210639|P1|Participant Flow|Levofloxacin|Participants who received levofloxacin in the previous studies.
1220493|NCT00214539|B2|Baseline|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
1220494|NCT00214539|B1|Baseline|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
1220495|NCT00214539|P2|Participant Flow|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
1220496|NCT00214539|P1|Participant Flow|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
1220497|NCT00214539|O2|Outcome|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
1220498|NCT00214539|O1|Outcome|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
1220499|NCT00214539|O2|Outcome|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
1220500|NCT00214539|O1|Outcome|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
1220501|NCT00214539|O2|Outcome|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
1220502|NCT00214539|O1|Outcome|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
1220503|NCT00214539|O2|Outcome|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
1220504|NCT00214539|O1|Outcome|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
1220505|NCT00214539|O2|Outcome|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
1220506|NCT00214539|O1|Outcome|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
1220507|NCT00214539|O2|Outcome|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
1220508|NCT00214539|O1|Outcome|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
1220509|NCT00214539|O2|Outcome|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
1220510|NCT00214539|O1|Outcome|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
1220511|NCT00214539|O2|Outcome|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
1220512|NCT00214539|O1|Outcome|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
1220513|NCT00214539|E6|Reported Event|Control (Steroid Wean and Reduced Steroid Phases)|
1220514|NCT00214539|E5|Reported Event|Alair (Steroid Wean and Reduced Steroid Phases)|
1220515|NCT00214539|E4|Reported Event|Control (Steroid Stable Phase)|
1220516|NCT00214539|E3|Reported Event|Alair (Steroid Stable Phase)|
1220517|NCT00214539|E2|Reported Event|Control (Treatment Period)|
1220518|NCT00214539|E1|Reported Event|Alair (Treatment Period)|
1220519|NCT00214526|B3|Baseline|Total|Total of all reporting groups
1220520|NCT00214526|B2|Baseline|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
1220521|NCT00214526|B1|Baseline|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
1220522|NCT00214526|P2|Participant Flow|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
1220523|NCT00214526|P1|Participant Flow|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
1220524|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
1220703|NCT00211887|B1|Baseline|IFN + GA|Interferon beta-1a intramuscularly weekly and glatiramer acetate daily
1220710|NCT00211887|O3|Outcome|Glatiramer|glatiramer acetate
1220525|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
1220526|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
1220559|NCT00214461|B3|Baseline|Medium-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
1220527|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
1220528|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
1220529|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
1220530|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
1220531|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
1220532|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
1220533|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
1220534|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
1220535|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
1220536|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
1220537|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
1220538|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
1220539|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
1220540|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
1220541|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
1220542|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
1220543|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
1220544|NCT00214526|E4|Reported Event|Control (Post-Treatment Period)|From 6 weeks after last Control visit through 1 year.
1220545|NCT00214526|E3|Reported Event|Alair (Post-Treatment Period)|From 6 weeks after last Treatment visit through 1 year.
1220546|NCT00214526|E2|Reported Event|Control (Treatment Period)|From first Control visit through 6 weeks after last Control visit.
1220547|NCT00214526|E1|Reported Event|Alair (Treatment Period)|From first Treatment visit through 6 weeks after last Treatment visit.
1220548|NCT00214487|B3|Baseline|Total|Total of all reporting groups
1220549|NCT00214487|B2|Baseline|Control|"Single vision soft contact lenses~Placebo Control: Single vision soft contact lenses"
1220550|NCT00214487|B1|Baseline|Bifocal Contact Lenses|"Use of bifocal contact lenses to control the progression of myopia~Bifocal Contact Lenses: Use of bifocal contact lenses of varying add powers to control the progression of myopia"
1220551|NCT00214487|P2|Participant Flow|Control|"Single vision soft contact lenses~Placebo Control: Single vision soft contact lenses"
1220552|NCT00214487|P1|Participant Flow|Bifocal Contact Lenses|"Use of bifocal contact lenses to control the progression of myopia~Bifocal Contact Lenses: Use of bifocal contact lenses of varying add powers to control the progression of myopia"
1220553|NCT00214487|O2|Outcome|Control|"Single vision soft contact lenses~Placebo Control: Single vision soft contact lenses"
1220554|NCT00214487|O1|Outcome|Bifocal Contact Lenses|"Use of bifocal contact lenses to control the progression of myopia~Bifocal Contact Lenses: Use of bifocal contact lenses of varying add powers to control the progression of myopia"
1220555|NCT00214487|E2|Reported Event|Control|"Single vision soft contact lenses~Placebo Control: Single vision soft contact lenses"
1220704|NCT00211887|P3|Participant Flow|Glatiramer Acetate|glatiramer acetate 20mg daily
1220556|NCT00214487|E1|Reported Event|Bifocal Contact Lenses|"Use of bifocal contact lenses to control the progression of myopia~Bifocal Contact Lenses: Use of bifocal contact lenses of varying add powers to control the progression of myopia"
1220557|NCT00214461|B5|Baseline|Total|Total of all reporting groups
1220558|NCT00214461|B4|Baseline|High-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
1220560|NCT00214461|B2|Baseline|Low-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
1220561|NCT00214461|B1|Baseline|Placebo Vaccine Group|Participants who received a dose of placebo, on Days 0, 28, and 56, respectively.
1220562|NCT00214461|P4|Participant Flow|High-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
1220563|NCT00214461|P3|Participant Flow|Medium-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
1220564|NCT00214461|P2|Participant Flow|Low-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
1220565|NCT00214461|P1|Participant Flow|Placebo Vaccine Group|Participants who received a dose of placebo, on Days 0, 28, and 56, respectively.
1220566|NCT00214461|O4|Outcome|High-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
1220567|NCT00214461|O3|Outcome|Medium-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
1220568|NCT00214461|O2|Outcome|Low-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
1220569|NCT00214461|O1|Outcome|Placebo Vaccine Group|Participants who received a dose of placebo, on Days 0, 28, and 56, respectively.
1220570|NCT00214461|O4|Outcome|High-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
1220571|NCT00214461|O3|Outcome|Medium-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
1220572|NCT00214461|O2|Outcome|Low-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
1220573|NCT00214461|O1|Outcome|Placebo Vaccine Group|Participants who received a dose of placebo, on Days 0, 28, and 56, respectively.
1220574|NCT00214461|E4|Reported Event|High-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
1220575|NCT00214461|E3|Reported Event|Medium-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
1220576|NCT00214461|E2|Reported Event|Low-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
1220577|NCT00214461|E1|Reported Event|Placebo Vaccine Group|Participants who received a dose of placebo, on Days 0, 28, and 56, respectively.
1220578|NCT00214383|B3|Baseline|Total|Total of all reporting groups
1220579|NCT00214383|B2|Baseline|Control|Control-usual care
1220580|NCT00214383|B1|Baseline|CHESS + Case Mgt|Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
1220581|NCT00214383|P2|Participant Flow|Control|Control-usual care
1220582|NCT00214383|P1|Participant Flow|CHESS + Case Mgt|Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
1220583|NCT00214383|O2|Outcome|Control|Control-usual care
1220584|NCT00214383|O1|Outcome|CHESS + Case Mgt|Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
1220585|NCT00214383|O2|Outcome|Control|Control-usual care
1220586|NCT00214383|O1|Outcome|CHESS + Case Mgt|Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
1220587|NCT00214383|O2|Outcome|Control|Control-usual care
1220588|NCT00214383|O1|Outcome|CHESS + Case Mgt|Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
1220589|NCT00214383|E2|Reported Event|Control|Control-usual care
1220590|NCT00214383|E1|Reported Event|CHESS + Case Mgt|Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
1220591|NCT00214201|B3|Baseline|Total|Total of all reporting groups
1220592|NCT00214201|B2|Baseline|CNI Withdrawal Post Campath 1H|"Calcineurin inhibitor withdrawal~Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy"
1220593|NCT00214201|B1|Baseline|CNI Control Post Campath 1H|Standard of Care CNI immunosuppression
1220594|NCT00214201|P2|Participant Flow|CNI Withdrawal Post Campath 1H|"Calcineurin inhibitor withdrawal~Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy"
1220595|NCT00214201|P1|Participant Flow|CNI Control Post Campath 1H|Standard of Care CNI immunosuppression
1220596|NCT00214201|O2|Outcome|CNI Withdrawal Post Campath 1H|Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy
1220597|NCT00214201|O1|Outcome|CNI Control Post Campath 1H|Standard of Care CNI immunosuppression
1220598|NCT00214201|O2|Outcome|CNI Withdrawal Post Campath 1H|Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy
1220599|NCT00214201|O1|Outcome|CNI Control Post Campath 1H|Standard of care CNI Immunosuppression
1220600|NCT00214201|O2|Outcome|CNI Withdrawal Post Campath 1H|Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy
1220601|NCT00214201|O1|Outcome|CNI Control Post Campath 1H|Standard of Care CNI immunosuppression
1220602|NCT00214201|E2|Reported Event|CNI Withdrawal Post Campath 1H|"Calcineurin inhibitor withdrawal~Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy"
1220603|NCT00214201|E1|Reported Event|CNI Control Post Campath 1H|Standard of Care CNI immunosuppression
1220604|NCT00214019|B1|Baseline|4 Way Cross Over|"Participants completed all 4 arms:~Placebo Salmeterol diskus 40 mcg twice per day Placebo then fluticasone Salmeterol then Fluticasone"
1220605|NCT00214019|P1|Participant Flow|Placebo/Placebo|Placebo Diskus/Placebo Diskus 28 days
1235832|NCT00132873|O1|Outcome|Xyrem (Sodium Oxybate)|
1220610|NCT00214019|E1|Reported Event|4 Way Cross Over|"Participants completed all 4 treatments:~Placebo Salmeterol diskus 50 mcg twice per day Placebo then Fluticasone Salmeterol then Fluticasone"
1220611|NCT00213135|B4|Baseline|Total|Total of all reporting groups
1220612|NCT00213135|B3|Baseline|Placebo|Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
1220613|NCT00213135|B2|Baseline|Cladribine 3.5 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
1220614|NCT00213135|B1|Baseline|Cladribine 5.25 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
1220615|NCT00213135|P3|Participant Flow|Placebo|Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
1220616|NCT00213135|P2|Participant Flow|Cladribine 3.5 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
1220617|NCT00213135|P1|Participant Flow|Cladribine 5.25 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
1220618|NCT00213135|O3|Outcome|Placebo|Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
1220619|NCT00213135|O2|Outcome|Cladribine 3.5 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
1220620|NCT00213135|O1|Outcome|Cladribine 5.25 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
1220621|NCT00213135|O3|Outcome|Placebo|Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
1220622|NCT00213135|O2|Outcome|Cladribine 3.5 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
1220623|NCT00213135|O1|Outcome|Cladribine 5.25 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
1220624|NCT00213135|O3|Outcome|Placebo|Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
1220625|NCT00213135|O2|Outcome|Cladribine 3.5 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
1220626|NCT00213135|O1|Outcome|Cladribine 5.25 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
1220627|NCT00213135|O3|Outcome|Placebo|Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
1220628|NCT00213135|O2|Outcome|Cladribine 3.5 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
1220629|NCT00213135|O1|Outcome|Cladribine 5.25 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
1220630|NCT00213135|E3|Reported Event|Placebo|Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
1220705|NCT00211887|P2|Participant Flow|Interferon Beta 1a|Interferon beta-1a 30µg intramuscularly weekly
1220706|NCT00211887|P1|Participant Flow|IFN + GA|Interferon beta-1a 30µg intramuscularly weekly and glatiramer acetate (GA) 20mg daily
1220631|NCT00213135|E2|Reported Event|Cladribine 3.5 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
1220632|NCT00213135|E1|Reported Event|Cladribine 5.25 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
1220633|NCT00210639|B3|Baseline|Total|Total of all reporting groups
1220634|NCT00210639|B2|Baseline|Comparator|Participants who received comparator in the previous studies.
1220635|NCT00210639|B1|Baseline|Levofloxacin|Participants who received levofloxacin in the previous studies.
1235833|NCT00132873|E1|Reported Event|Xyrem (Sodium Oxybate)|
1220639|NCT00210639|O1|Outcome|Levofloxacin|Participants who received levofloxacin in the previous studies.
1220640|NCT00210639|E2|Reported Event|Comparator|Participants who received comparator in the previous studies.
1220641|NCT00210639|E1|Reported Event|Levofloxacin|Participants who received levofloxacin in the previous studies.
1220642|NCT00210626|B3|Baseline|Total|Total of all reporting groups
1220643|NCT00210626|B2|Baseline|Placebo|Placebo given at equivalent volume (1 mL) as Procrit
1220644|NCT00210626|B1|Baseline|PROCRIT|40,000 IU/mL/week for maximum of 12 weeks
1220645|NCT00210626|P2|Participant Flow|Placebo|Placebo given at equivalent volume (1 mL) as Procrit
1220646|NCT00210626|P1|Participant Flow|PROCRIT|40,000 IU/mL/week for maximum of 12 weeks
1220647|NCT00210626|O2|Outcome|Placebo|Placebo given at equivalent volume (1 mL) as Procrit
1220648|NCT00210626|O1|Outcome|PROCRIT|40,000 IU/mL/week for maximum of 12 weeks
1220649|NCT00210626|O2|Outcome|Placebo|Placebo given at equivalent volume (1 mL) as Procrit
1220650|NCT00210626|O1|Outcome|PROCRIT|40,000 IU/mL/week for maximum of 12 weeks
1220651|NCT00210626|E2|Reported Event|Placebo|Placebo given at equivalent volume (1 mL) as Procrit
1220652|NCT00210626|E1|Reported Event|PROCRIT|40,000 IU/mL/week for maximum of 12 weeks
1220653|NCT00212758|B1|Baseline|All Participants|Subjects will be randomized to either a low or standard arm. The low dose will get 0.025 mg/kg/day of growth hormone therapy and the standard dose arm will receive 0.05 mg/kg/dose given subcutaneously. After one week of therapy and 2 weeks of wash out, subjects will change the dose of GH therapy and will receive the alternate dose for another week. After that all subjects will be treated with the standard dose of GH therapy of 0.05 mg/kg/day for 6 months, re-evaluate growth velocity and then continue for another 6 months on GH.
1220654|NCT00212758|P2|Participant Flow|Standard- Low- Standard GH|This group was randomized to receive 0.05 mg/kg/day of growth hormone for 7 doses given subcutaneously followed by 2 weeks of wash out and then another 7 days of GH therapy (Nutropin AQ) at the low dose of 0.025 mg/kg/day for 7 days.
1220655|NCT00212758|P1|Participant Flow|Low-standard-standard GH|This group was randomized to receive 0.025 mg/kg/day of growth hormone for 7 doses given subcutaneously, followed by 2 weeks of wash out and then another 7 days of GH therapy (Nutropin AQ) at the standard dose of 0.05 mg/kg/day for 7 days.
1220656|NCT00212758|O1|Outcome|All Participants|Subjects will be randomized to either a low or standard arm. The low dose will get 0.025 mg/kg/day of growth hormone therapy and the standard dose arm will receive 0.05 mg/kg/dose given subcutaneously. After one week of therapy and 2 weeks of wash out, subjects will change the dose of GH therapy and will receive the alternate dose for another week. After that all subjects will be treated with the standard dose of GH therapy of 0.05 mg/kg/day for 6 months, re-evaluate growth velocity and then continue for another 6 months on GH.
1220657|NCT00212758|O2|Outcome|Standard Dose GH|Subjects will be randomized to either a low or standard arm. The Standard dose GH group will get 0.05 mg/kg/day of growth hormone therapy for 7 days followed by 2 week wash out and then another 7 days of GH therapy on the low dose of 0.025 mg/kg/dose given subcutaneously.
1220658|NCT00212758|O1|Outcome|Low Dose GH|Subjects will be randomized to either a low or standard arm. The low dose GH group will get 0.025 mg/kg/day of growth hormone therapy for 7 days followed by 2 weeks of wash out and then another 7 days of GH therapy on the standard dose of 0.05 mg/kg/dose given subcutaneously.
1220659|NCT00212758|E1|Reported Event|All Participants|There will be 2 arms in the study who will be randomized in a cross over design. The low dose will get 0.025 mg/kg/day of growth hormone therapy and the standard dose arm will receive 0.05 mg/kg/dose given subcutaneously. After one week of therapy and 2 weeks of wash out, subjects will change the dose of GH therapy and will receive the alternate dose for another week. After that all subjects will be treated with the standard dose of GH therapy of 0.05 mg/kg/day for 6 months.
1220660|NCT00212355|B1|Baseline|NPC-02|"zinc acetate~NPC-02: zinc acetate"
1220661|NCT00212355|P1|Participant Flow|NPC-02|"zinc acetate~NPC-02: zinc acetate"
1220662|NCT00212355|O1|Outcome|NPC-02|"zinc acetate~NPC-02: zinc acetate"
1220663|NCT00212355|E1|Reported Event|NPC-02|"zinc acetate~NPC-02: zinc acetate"
1220664|NCT00212264|B4|Baseline|Total|Total of all reporting groups
1220665|NCT00212264|B3|Baseline|Placebo Comparator|No treatment control
1220666|NCT00212264|B2|Baseline|Behavioral Therapy Plus Technologies|"Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies~Pelvic Floor Electrical Stimulation: Pelvic Floor Electrical Stimulation daily for 8 weeks~Biofeedback: Pelvic Floor Muscle training via biofeedback"
1220667|NCT00212264|B1|Baseline|Behavioral Therapy|"Behavioral Therapy (Pelvic floor muscle training, bladder control strategies)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies"
1220668|NCT00212264|P3|Participant Flow|Placebo Comparator|No treatment control
1220707|NCT00211887|O3|Outcome|Glatiramer|glatiramer acetate
1220708|NCT00211887|O2|Outcome|IFB-1a|Interferon beta-1a
1220709|NCT00211887|O1|Outcome|IFN + GA|Interferon beta-1a intramuscularly weekly and glatiramer acetate daily
1220669|NCT00212264|P2|Participant Flow|Behavioral Therapy Plus Technologies|"Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies~Pelvic Floor Electrical Stimulation: Pelvic Floor Electrical Stimulation daily for 8 weeks~Biofeedback: Pelvic Floor Muscle training via biofeedback"
1220670|NCT00212264|P1|Participant Flow|Behavioral Therapy|"Behavioral Therapy (Pelvic floor muscle training, bladder control strategies)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies"
1220671|NCT00212264|O2|Outcome|Behavioral Therapy Plus Technologies|"Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies~Pelvic Floor Electrical Stimulation: Pelvic Floor Electrical Stimulation daily for 8 weeks~Biofeedback: Pelvic Floor Muscle training via biofeedback"
1220672|NCT00212264|O1|Outcome|Behavioral Therapy|"Behavioral Therapy (Pelvic floor muscle training, bladder control strategies)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies"
1220673|NCT00212264|O3|Outcome|Placebo Comparator|No treatment control
1220830|NCT00209417|E1|Reported Event|Iodixanol 320-Arm 1|"Iodixanol 320 mg I/mL~Iodixanol 320-Arm 1"
1220674|NCT00212264|O2|Outcome|Behavioral Therapy Plus Technologies|"Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies~Pelvic Floor Electrical Stimulation: Pelvic Floor Electrical Stimulation daily for 8 weeks~Biofeedback: Pelvic Floor Muscle training via biofeedback"
1220675|NCT00212264|O1|Outcome|Behavioral Therapy|"Behavioral Therapy (Pelvic floor muscle training, bladder control strategies)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies"
1220676|NCT00212264|E3|Reported Event|Placebo Comparator|No treatment control
1220677|NCT00212264|E2|Reported Event|Behavioral Therapy Plus Technologies|"Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies~Pelvic Floor Electrical Stimulation: Pelvic Floor Electrical Stimulation daily for 8 weeks~Biofeedback: Pelvic Floor Muscle training via biofeedback"
1220678|NCT00212264|E1|Reported Event|Behavioral Therapy|"Behavioral Therapy (Pelvic floor muscle training, bladder control strategies)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies"
1220679|NCT00212134|B3|Baseline|Total|Total of all reporting groups
1220680|NCT00212134|B2|Baseline|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: aphakic intraocular lens"
1220681|NCT00212134|B1|Baseline|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: aphakic contact lens"
1220682|NCT00212134|P2|Participant Flow|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: aphakic intraocular lens"
1220683|NCT00212134|P1|Participant Flow|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: aphakic contact lens"
1220684|NCT00212134|O2|Outcome|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: aphakic intraocular lens"
1220685|NCT00212134|O1|Outcome|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: aphakic contact lens"
1220686|NCT00212134|O2|Outcome|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: aphakic intraocular lens"
1220687|NCT00212134|O1|Outcome|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: aphakic contact lens"
1220688|NCT00212134|O2|Outcome|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: aphakic intraocular lens"
1220689|NCT00212134|O1|Outcome|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: aphakic contact lens"
1220690|NCT00212134|O2|Outcome|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: aphakic intraocular lens"
1220691|NCT00212134|O1|Outcome|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: aphakic contact lens"
1220692|NCT00212134|O2|Outcome|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: aphakic intraocular lens"
1220693|NCT00212134|O1|Outcome|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: aphakic contact lens"
1220694|NCT00212134|O2|Outcome|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: At the time of surgery to remove the cataractous natural lens, an intraocular lens was implanted to correct the large hyperopic refractive error induced by the cataract surgery.~primary implantation of aphakic intraocular lens: optical correction of surgical aphakia with intraocular lens"
1220695|NCT00212134|O1|Outcome|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: use of an external contact lens (CL) to correct the large hyperopic refractive error produced by surgically extracting the natural cataractous lens. As the eye grows, the refractive error changes and the power of the CL can be changed accordingly.~hyperopic correction of infant surgical aphakia with Contact Lens: optical correction of infant surgical aphakia with Contact lens"
1220696|NCT00212134|O2|Outcome|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: The refractive error induced by surgical removal of the cataractous natural lens is partially corrected by the implantation of an intraocular lens (IOL) at the time of surgery. This is deemed a permanent correction as the IOL may only be removed in a subsequent surgery."
1220697|NCT00212134|O1|Outcome|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: use of an external contact lens (CL) to correct the large hyperopic refractive error produced by surgically extracting the natural cataractous lens. As the eye grows, the refractive error changes and the power of the CL can be changed accordingly."
1220698|NCT00212134|E2|Reported Event|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: aphakic intraocular lens"
1220699|NCT00212134|E1|Reported Event|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: aphakic contact lens"
1220700|NCT00211887|B4|Baseline|Total|Total of all reporting groups
1220701|NCT00211887|B3|Baseline|Glatiramer|glatiramer acetate
1220702|NCT00211887|B2|Baseline|IFB-1a|Interferon beta-1a
1220711|NCT00211887|O2|Outcome|IFB-1a|Interferon beta-1a
1220712|NCT00211887|O1|Outcome|IFN + GA|Interferon beta-1a intramuscularly weekly and glatiramer acetate daily
1220713|NCT00211887|O3|Outcome|Glatiramer|glatiramer acetate
1220714|NCT00211887|O2|Outcome|IFB-1a|Interferon beta-1a
1220715|NCT00211887|O1|Outcome|IFN + GA|Interferon beta-1a intramuscularly weekly and glatiramer acetate daily
1220716|NCT00211887|O3|Outcome|Glatiramer|glatiramer acetate
1220717|NCT00211887|O2|Outcome|IFB-1a|Interferon beta-1a
1220718|NCT00211887|O1|Outcome|IFN + GA|Interferon beta-1a intramuscularly weekly and glatiramer acetate daily
1220719|NCT00211887|E3|Reported Event|Glatiramer|glatiramer acetate
1220720|NCT00211887|E2|Reported Event|IFB-1a|Interferon beta-1a
1220721|NCT00211887|E1|Reported Event|IFN + GA|Interferon beta-1a intramuscularly weekly and glatiramer acetate daily
1220722|NCT00211809|B1|Baseline|Body Dysmorphic Disorder|Participants with body dysmorphic disorder
1220946|NCT00209027|B1|Baseline|Schizophrenia Subjects|Baseline fMRI, switch from baseline medication to aripiprazole, then repeat fMRI scan after 12 weeks of treatment.
1220723|NCT00211809|P1|Participant Flow|Body Dysmorphic Disorder|"Participants with body dysmorphic disorder~Standard Psychiatric Evaluation~Venlafaxine: start dose of 37.5 mg/day and increased to a minimum of 150mg/day, generally over the first 4 weeks and then maintained at that dose for 8 weeks."
1220724|NCT00211809|O2|Outcome|Endpoint|Participants with Body Dysmorphic Disorder after Venlafaxine treatment up to 16 weeks
1220725|NCT00211809|O1|Outcome|Baseline|Participants with Body Dysmorphic Disorder at baseline
1220726|NCT00211809|O2|Outcome|Endpoint|Participants with Body Dysmorphic Disorder after Venlafaxine treatment up to 16 weeks
1220727|NCT00211809|O1|Outcome|Baseline|Participants with Body Dysmorphic Disorder at baseline
1220728|NCT00211809|O2|Outcome|Endpoint|Participants with Body Dysmorphic Disorder after Venlafaxine treatment up to 16 weeks
1220729|NCT00211809|O1|Outcome|Baseline|Participants with Body Dysmorphic Disorder at baseline
1220730|NCT00211809|O1|Outcome|Body Dysmorphic Disorder|Participants with body dysmorphic disorder after Venlafaxine treatment up to 16 weeks
1220731|NCT00211809|O2|Outcome|Endpoint|Participants with Body Dysmorphic Disorder after Venlafaxine treatment up to 16 weeks
1220732|NCT00211809|O1|Outcome|Baseline|Participants with Body Dysmorphic Disorder at baseline
1220733|NCT00211809|O2|Outcome|Endpoint|Participants with Body Dysmorphic Disorder after Venlafaxine treatment up to 16 weeks
1220734|NCT00211809|O1|Outcome|Baseline|Participants with Body Dysmorphic Disorder at baseline
1220735|NCT00211809|E1|Reported Event|Body Dysmorphic Disorder|Participants with body dysmorphic disorder
1220736|NCT00211692|B3|Baseline|Total|Total of all reporting groups
1220737|NCT00211692|B2|Baseline|Group B Duration Based on Viral Response|CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given for 52-72 weeks (from time of viral response +48 weeks) (group B)
1220738|NCT00211692|B1|Baseline|Group A 52 Weeks Treatment|Daily CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given 52 weeks (group A)
1220739|NCT00211692|P2|Participant Flow|Group B Duration Based on Viral Response|CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given for 52-72 weeks (from time of viral response +48 weeks) (group B)
1220740|NCT00211692|P1|Participant Flow|Group A 52 Weeks Treatment|Daily CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given 52 weeks (group A)
1220741|NCT00211692|O1|Outcome|Overall|
1220742|NCT00211692|O1|Outcome|Overall|
1220743|NCT00211692|O1|Outcome|Overall|
1220744|NCT00211692|O2|Outcome|B (Duration Based on Viral Response)|
1220745|NCT00211692|O1|Outcome|A (52 Weeks Treatment)|
1220746|NCT00211692|E1|Reported Event|Overall|
1220747|NCT00211536|B3|Baseline|Total|Total of all reporting groups
1220748|NCT00211536|B2|Baseline|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.~For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
1220749|NCT00211536|B1|Baseline|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
1220750|NCT00211536|P2|Participant Flow|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.~For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
1220787|NCT00211237|P1|Participant Flow|Balloon Kyphoplasty|Randomized, Unblinded Controlled Study
1220788|NCT00211237|O2|Outcome|Non Surgical Management|Non-surgical treatment aimed at alleviation of back pain and restoration of decreased function associated with VCF(s).
1220789|NCT00211237|O1|Outcome|Balloon Kyphoplasty|Randomized, Unblinded Controlled Study
1220790|NCT00211237|E2|Reported Event|Non Surgical Management|Non-surgical treatment aimed at alleviation of back pain and restoration of decreased function associated with VCF(s).
1220751|NCT00211536|P1|Participant Flow|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
1220831|NCT00209339|B1|Baseline|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220752|NCT00211536|O2|Outcome|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.~For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
1220753|NCT00211536|O1|Outcome|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
1220754|NCT00211536|O2|Outcome|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.~For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
1220755|NCT00211536|O1|Outcome|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
1220756|NCT00211536|O2|Outcome|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.~For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
1220757|NCT00211536|O1|Outcome|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
1220758|NCT00211536|O2|Outcome|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.~For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
1220791|NCT00211237|E1|Reported Event|Balloon Kyphoplasty|Randomized, Unblinded Controlled Study
1220792|NCT00211172|B3|Baseline|Total|Total of all reporting groups
1220819|NCT00209560|E1|Reported Event|Fospropofol Disodium|525 mg to 980 mg (dose based on weight and age): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 105 mg to 140 mg (based on weight and age) were administered as needed.
1220820|NCT00209417|B3|Baseline|Total|Total of all reporting groups
1220821|NCT00209417|B2|Baseline|Iopamidol 300-Arm 2|"Iopamidol 300 mg I/mL~Iopamidol 300-Arm 2"
1220822|NCT00209417|B1|Baseline|Iodixanol 320-Arm 1|"Iodixanol 320 mg I/mL~Iodixanol 320-Arm 1"
1220759|NCT00211536|O1|Outcome|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
1220760|NCT00211536|O2|Outcome|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.~For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
1220761|NCT00211536|O1|Outcome|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
1220762|NCT00211536|E2|Reported Event|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.~For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group. All randomized subjects were assessed for safety risk."
1220763|NCT00211536|E1|Reported Event|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.~Results were analyzed for subjects that completed beyond V5, which was the end of the first 90 day period of IP insulin therapy. These were considered to be the As Treated group.~All randomized subjects were assessed for safety risk."
1220764|NCT00211510|B3|Baseline|Total|Total of all reporting groups
1220765|NCT00211510|B2|Baseline|Paradigm 715 Insulin Pump|subjects will use the Paradigm 715 insulin pump for insulin infusion
1220766|NCT00211510|B1|Baseline|Paradigm 722 Sensor Augmented Pump|subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring
1220767|NCT00211510|P2|Participant Flow|Paradigm 715 Insulin Pump|subjects with use the Paradigm 715 insulin pump for insulin infusion
1220768|NCT00211510|P1|Participant Flow|Paradigm 722 Sensor Augmented Pump|subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring
1220769|NCT00211510|O2|Outcome|Paradigm 715 Insulin Pump|subjects will use the Paradigm 715 insulin pump for insulin infusion
1220770|NCT00211510|O1|Outcome|Paradigm 722 Sensor Augmented Pump|subjects will use the Paradigm 711 sensor augmented pump for insulin infusion and continuous glucose monitoring
1220771|NCT00211510|O2|Outcome|Paradigm 715 Insulin Pump|subjects will use the Paradigm 715 insulin pump for insulin infusion
1220772|NCT00211510|O1|Outcome|Paradigm 722 Sensor Augmented Pump|subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring
1220773|NCT00211510|O2|Outcome|Paradigm 715 Insulin Pump|subjects will use the Paradigm 715 insulin pump for insulin infusion
1220774|NCT00211510|O1|Outcome|Paradigm 722 Sensor Augmented Pump|subjects with use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring
1220775|NCT00211510|O2|Outcome|Paradigm 715 Insulin Pump|subjects will use the Paradigm 715 insulin pump for insulin infusion
1220776|NCT00211510|O1|Outcome|Paradigm 722 Sensor Augmented Pump|subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring
1220777|NCT00211510|O2|Outcome|Paradigm 715 Insulin Pump|subjects will use the Paradigm 715 pump for insulin infusion
1220778|NCT00211510|O1|Outcome|Paradigm 722 Sensor Augmented Pump|subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring
1220779|NCT00211510|O2|Outcome|Paradigm 715 Insulin Pump|subjects will use the Paradigm 715 insulin pump for insulin infusion
1220780|NCT00211510|O1|Outcome|Paradigm 722 Sensor Augmented Pump|subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring
1220781|NCT00211510|E2|Reported Event|Paradigm 715 Insulin Pump|subjects will use the Paradigm 715 insulin pump for insulin infusion
1220782|NCT00211510|E1|Reported Event|Paradigm 722 Sensor Augmented Pump|subjects will use the Paradigm 722 sensor augmented pump for insulin infusion and continuous glucose monitoring
1220783|NCT00211237|B3|Baseline|Total|Total of all reporting groups
1220784|NCT00211237|B2|Baseline|Non Surgical Management|Non-surgical treatment aimed at alleviation of back pain and restoration of decreased function associated with VCF(s).
1220785|NCT00211237|B1|Baseline|Balloon Kyphoplasty|Randomized, Unblinded Controlled Study
1220786|NCT00211237|P2|Participant Flow|Non Surgical Management|Non-surgical treatment aimed at alleviation of back pain and restoration of decreased function associated with VCF(s).
1220793|NCT00211172|B2|Baseline|Reminder Mailing|The intervention consisted of 2 mailed communications. A personalized letter was mailed first, followed approximately 2 months later by a similar letter and an accompanying brochure. Both mailings also included a wallet card that suggested questions for the patient to ask their clinician, space to list their medications, and space to record additional queries. The communications contained nearly identical information, stressing the importance of lifetime use of beta-blockers following acute myocardial infarction (AMI) and that adverse effects can be managed and the importance of remembering to refill their prescription. They also included a brief mention of other therapies (statins, ACE inhibitors [ACEIs], and aspirin).
1220794|NCT00211172|B1|Baseline|Usual Care|Usual care patients were not contacted by the study.
1220795|NCT00211172|P2|Participant Flow|Reminder Mailing|The intervention consisted of 2 mailed communications. A personalized letter was mailed first, followed approximately 2 months later by a similar letter and an accompanying brochure. Both mailings also included a wallet card that suggested questions for the patient to ask their clinician, space to list their medications, and space to record additional queries. The communications contained nearly identical information, stressing the importance of lifetime use of beta-blockers following acute myocardial infarction (AMI) and that adverse effects can be managed and the importance of remembering to refill their prescription. They also included a brief mention of other therapies (statins, ACE inhibitors [ACEIs], and aspirin).
1220796|NCT00211172|P1|Participant Flow|Usual Care|Usual care patients were not contacted by the study.
1220797|NCT00211172|O2|Outcome|Reminder Mailing|The intervention consisted of 2 mailed communications. A personalized letter was mailed first, followed approximately 2 months later by a similar letter and an accompanying brochure. Both mailings also included a wallet card that suggested questions for the patient to ask their clinician, space to list their medications, and space to record additional queries. The communications contained nearly identical information, stressing the importance of lifetime use of beta-blockers following acute myocardial infarction (AMI) and that adverse effects can be managed and the importance of remembering to refill their prescription. They also included a brief mention of other therapies (statins, ACE inhibitors [ACEIs], and aspirin).
1220798|NCT00211172|O1|Outcome|Usual Care|Usual care patients were not contacted by the study.
1220799|NCT00211172|E2|Reported Event|Reminder Mailing|The intervention consisted of 2 mailed communications. A personalized letter was mailed first, followed approximately 2 months later by a similar letter and an accompanying brochure. Both mailings also included a wallet card that suggested questions for the patient to ask their clinician, space to list their medications, and space to record additional queries. The communications contained nearly identical information, stressing the importance of lifetime use of beta-blockers following acute myocardial infarction (AMI) and that adverse effects can be managed and the importance of remembering to refill their prescription. They also included a brief mention of other therapies (statins, ACE inhibitors [ACEIs], and aspirin).
1220800|NCT00211172|E1|Reported Event|Usual Care|Usual care patients were not contacted by the study.
1220801|NCT00211081|B1|Baseline|Spironolactone|Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
1220802|NCT00211081|P1|Participant Flow|Spironolactone|Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
1220803|NCT00211081|O1|Outcome|Spironolactone|Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
1220804|NCT00211081|E1|Reported Event|Spironolactone|Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
1220805|NCT00210470|B1|Baseline|IRX-2 Regimen|The IRX-2 regimen is the combination of a 2-week course of IRX-2 itself, an initial dose of cyclophosphamide, and a 3-week course of indomethacin and zinc supplementation.
1220806|NCT00210470|P1|Participant Flow|IRX-2 Regimen|The IRX-2 regimen is the combination of a 2-week course of IRX-2 itself, an initial dose of cyclophosphamide, and a 3-week course of indomethacin and zinc supplementation.
1220807|NCT00210470|O1|Outcome|IRX-2 Regimen|A 2-week course of IRX-2, an initial low dose of cyclophosphamide, and a 3-week course of indomethacin and zinc supplementation
1220808|NCT00210470|E1|Reported Event|IRX-2 Regimen|The IRX-2 regimen is the combination of a 2-week course of IRX-2 itself, an initial dose of cyclophosphamide, and a 3-week course of indomethacin and zinc supplementation.
1220809|NCT00209560|B3|Baseline|Total|Total of all reporting groups
1220810|NCT00209560|B2|Baseline|Midazolam|0.5 to 2 mg (dose based on weight and age): one initial i.v. bolus dose. Supplemental doses of midazolam 0.25 mg to 1 mg (based on weight and age) were administered as needed.
1220811|NCT00209560|B1|Baseline|Fospropofol Disodium|525 mg to 980 mg (dose based on weight and age): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 105 mg to 140 mg (based on weight and age) were administered as needed.
1220812|NCT00209560|P2|Participant Flow|Midazolam|0.5 to 2 mg (dose based on weight and age): one initial i.v. bolus dose. Supplemental doses of midazolam 0.25 mg to 1 mg (based on weight and age) were administered as needed.
1220813|NCT00209560|P1|Participant Flow|Fospropofol Disodium|525 mg to 980 mg (dose based on weight and age): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 105 mg to 140 mg (based on weight and age) were administered as needed.
1220814|NCT00209560|O2|Outcome|Midazolam|0.5 to 2 mg (dose based on weight and age): one initial i.v. bolus dose. Supplemental doses of midazolam 0.25 mg to 1 mg (based on weight and age) were administered as needed.
1220815|NCT00209560|O1|Outcome|Fospropofol Disodium|525 mg to 980 mg (dose based on weight and age): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 105 mg to 140 mg (based on weight and age) were administered as needed.
1220816|NCT00209560|O2|Outcome|Midazolam|0.5 to 2 mg (dose based on weight and age): one initial i.v. bolus dose. Supplemental doses of midazolam 0.25 mg to 1 mg (based on weight and age) were administered as needed.
1220817|NCT00209560|O1|Outcome|Fospropofol Disodium|525 mg to 980 mg (dose based on weight and age): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 105 mg to 140 mg (based on weight and age) were administered as needed.
1220818|NCT00209560|E2|Reported Event|Midazolam|0.5 to 2 mg (dose based on weight and age): one initial i.v. bolus dose. Supplemental doses of midazolam 0.25 mg to 1 mg (based on weight and age) were administered as needed.
1220823|NCT00209417|P2|Participant Flow|Iopamidol 300-Arm 2|"Iopamidol 300 mg I/mL~Iopamidol 300-Arm 2"
1220824|NCT00209417|P1|Participant Flow|Iodixanol 320-Arm 1|"Iodixanol 320 mg I/mL~Iodixanol 320-Arm 1"
1220825|NCT00209417|O2|Outcome|Iopamidol 300-Arm 2|"Iopamidol 300 mg I/mL~Iopamidol 300-Arm 2"
1220826|NCT00209417|O1|Outcome|Iodixanol 320-Arm 1|"Iodixanol 320 mg I/mL~Iodixanol 320-Arm 1"
1220827|NCT00209417|O2|Outcome|Iopamidol 300-Arm 2|"Iopamidol 300 mg I/mL~Iopamidol 300-Arm 2"
1220828|NCT00209417|O1|Outcome|Iodixanol 320-Arm 1|"Iodixanol 320 mg I/mL~Iodixanol 320-Arm 1"
1220829|NCT00209417|E2|Reported Event|Iopamidol 300-Arm 2|"Iopamidol 300 mg I/mL~Iopamidol 300-Arm 2"
1220945|NCT00209027|B2|Baseline|Controls|Baseline fMRI scan
1220832|NCT00209339|P1|Participant Flow|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220833|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220834|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220835|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220836|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220837|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220838|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220839|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220840|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220841|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220842|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220843|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220844|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220845|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220846|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220847|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220848|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220849|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220850|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220851|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220852|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220853|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1221137|NCT00207740|B2|Baseline|Group II: Golimumab 50 mg|Golimumab (CNTO148) 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
1220854|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220855|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220856|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220857|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220947|NCT00209027|P2|Participant Flow|Controls|Baseline fMRI scan
1220858|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220859|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220860|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220861|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220862|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220863|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220864|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220865|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220866|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220867|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220868|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220869|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220870|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220871|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220872|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220873|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220874|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220875|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220876|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220877|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220878|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220879|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220880|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220881|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220882|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220883|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220884|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220885|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220886|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220887|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220888|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220889|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220890|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220891|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220892|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220893|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220894|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220895|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220896|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220897|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220898|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220899|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220900|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220901|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220902|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220903|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220904|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220905|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220906|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220907|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220908|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220909|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220910|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220911|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220912|NCT00209339|E1|Reported Event|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
1220913|NCT00209170|B3|Baseline|Total|Total of all reporting groups
1220914|NCT00209170|B2|Baseline|Beating the Blues CBT + Placebo|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with placebo (taken orally one to two tablets daily) for 6 months
1220915|NCT00209170|B1|Baseline|Beating the Blues CBT + Escitalopram|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with the selective serotonin reuptake inhibitor (SSRI) antidepressant, escitalopram (10 mg taken orally once or twice daily) for 6 months
1220916|NCT00209170|P2|Participant Flow|Beating the Blues CBT + Placebo|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with placebo (taken orally one to two tablets daily) for 6 months
1220917|NCT00209170|P1|Participant Flow|Beating the Blues CBT + Escitalopram|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with the selective serotonin reuptake inhibitor (SSRI) antidepressant, escitalopram (10 mg taken orally once or twice daily) for 6 months
1220918|NCT00209170|O2|Outcome|Beating the Blues CBT + Placebo|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with placebo (taken orally one to two tablets daily) for 6 months
1220919|NCT00209170|O1|Outcome|Beating the Blues CBT + Escitalopram|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with the selective serotonin reuptake inhibitor (SSRI) antidepressant, escitalopram (10 mg taken orally once or twice daily) for 6 months
1220920|NCT00209170|E2|Reported Event|Beating the Blues CBT + Placebo|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with placebo (taken orally one to two tablets daily) for 6 months
1220921|NCT00209170|E1|Reported Event|Beating the Blues CBT + Escitalopram|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with the selective serotonin reuptake inhibitor (SSRI) antidepressant, escitalopram (10 mg taken orally once or twice daily) for 6 months
1220922|NCT00209131|B3|Baseline|Total|Total of all reporting groups
1220923|NCT00209131|B2|Baseline|Sugar Pill|Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
1220924|NCT00209131|B1|Baseline|Flomax|Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.
1220925|NCT00209131|P2|Participant Flow|Sugar Pill|Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
1220926|NCT00209131|P1|Participant Flow|Flomax|Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.
1220927|NCT00209131|O2|Outcome|Sugar Pill|Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
1220928|NCT00209131|O1|Outcome|Flomax|Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.
1220929|NCT00209131|O2|Outcome|Sugar Pill|Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
1220930|NCT00209131|O1|Outcome|Flomax|Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.
1220931|NCT00209131|E2|Reported Event|Sugar Pill|Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
1220932|NCT00209131|E1|Reported Event|Flomax|Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.
1220933|NCT00209092|B3|Baseline|Total|Total of all reporting groups
1220934|NCT00209092|B2|Baseline|Arm B:Concurrent Therapy|Docetaxel will be given at 50mg/m^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
1220935|NCT00209092|B1|Baseline|Arm A:Sequential Therapy|Docetaxel will be given at 100mg/m^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
1220936|NCT00209092|P2|Participant Flow|Arm B:Concurrent Therapy|Docetaxel will be given at 50mg/m^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
1220937|NCT00209092|P1|Participant Flow|Arm A:Sequential Therapy|Docetaxel will be given at 100mg/m^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
1220938|NCT00209092|O2|Outcome|Arm B:Concurrent Therapy|Docetaxel will be given at 50mg/m^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
1220939|NCT00209092|O1|Outcome|Arm A:Sequential Therapy|Docetaxel will be given at 100mg/m^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
1221138|NCT00207740|B1|Baseline|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
1220940|NCT00209092|O2|Outcome|Arm B:Concurrent Therapy|Docetaxel will be given at 50mg/m^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
1220941|NCT00209092|O1|Outcome|Arm A:Sequential Therapy|Docetaxel will be given at 100mg/m^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
1220942|NCT00209092|E2|Reported Event|Arm B:Concurrent Therapy|Docetaxel will be given at 50mg/m^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
1220943|NCT00209092|E1|Reported Event|Arm A:Sequential Therapy|Docetaxel will be given at 100mg/m^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
1220944|NCT00209027|B3|Baseline|Total|Total of all reporting groups
1220948|NCT00209027|P1|Participant Flow|Schizophrenia Subjects|Baseline fMRI, switch from baseline medication to aripiprazole, then repeat fMRI scan after 12 weeks of treatment.
1220949|NCT00209027|O2|Outcome|Controls|Healthy males without a psychiatric diagnosis
1220950|NCT00209027|O1|Outcome|Schizophrenia Subjects|Males patients with schizophrenia
1220951|NCT00209027|E2|Reported Event|Controls|Baseline fMRI scan
1220952|NCT00209027|E1|Reported Event|Schizophrenia Subjects|Baseline fMRI, switch from baseline medication to aripiprazole, then repeat fMRI scan after 12 weeks of treatment.
1220953|NCT00208975|B1|Baseline|Fludarabine and Cyclophosphamide With Sequential Administratio|Patients will receive fludarabine and cyclophosphamide with sequential administration of GM-CSF on days 6 and 7 and rituximab on day 8.
1220954|NCT00208975|P1|Participant Flow|Fludarabine and Cyclophosphamide With Sequential Administratio|Patients will receive fludarabine and cyclophosphamide with sequential administration of GM-CSF on days 6 and 7 and rituximab on day 8.
1220955|NCT00208975|O2|Outcome|Non Hodgkin Lymphoma|"Non-Hodgkin's lymphoma, also called non-Hodgkin lymphoma, is cancer that originates in your lymphatic system, the disease-fighting network spread throughout your body. In non-Hodgkin's lymphoma, tumors develop from lymphocytes — a type of white blood cell.~Fludarabine-based combination provide effective treatment for patients with low-grade NHL and CLL with high complete response rates that are improved with the addition of Rituximab."
1220956|NCT00208975|O1|Outcome|Chronic Lymphocytic Leukemia|"Chronic Lymphocytic Leukemia (CLL) is a condition characterized by an accumulation of abnormal lymphocytes in the blood and the bone marrow. These lymphocytes do not perform their functions as normal ones would and interfere with the production of other blood cells necessary for the normal functioning of the blood, leading to a host of complications like deficiency of the immune system, coagulation problems, swollen lymph nodes, and many other conditions.~Fludarabine-based combination provide effective treatment for patients with low-grade NHL and CLL with high complete response rates that are improved with the addition of Rituximab."
1220957|NCT00208975|E1|Reported Event|Fludarabine and Cyclophosphamide With Sequential Administratio|Patients will receive fludarabine and cyclophosphamide with sequential administration of GM-CSF on days 6 and 7 and rituximab on day 8.
1220958|NCT00208949|B3|Baseline|Total|Total of all reporting groups
1220959|NCT00208949|B2|Baseline|G-CSF and GM-CSF (Granulocyte Macrophage)|Combined use of G-CSF and GM-CSF
1220960|NCT00208949|B1|Baseline|G-CSF (Granulocyte Colony- Stimulating Factor)|Single use of G-CSF
1220961|NCT00208949|P2|Participant Flow|G-CSF and GM-CSF (Granulocyte Macrophage)|Combined use of G-CSF and GM-CSF
1220962|NCT00208949|P1|Participant Flow|G-CSF (Granulocyte Colony- Stimulating Factor)|Single use of G-CSF
1220963|NCT00208949|O2|Outcome|G-CSF and GM-CSF (Granulocyte Macrophage)|Combined use of G-CSF(Granulocyte Colony-Stimulating Factor ) and GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) (G-CSF 7.5 µg/kg / GM-CSF 7.5 µg/kg.)
1220964|NCT00208949|O1|Outcome|G-CSF (Granulocyte Colony- Stimulating Factor)|Single use of G-CSF(Granulocyte Colony-Stimulating Factor ) G-CSF 7.5 µg/kg twice a day
1220965|NCT00208949|O2|Outcome|G-CSF and GM-CSF (Granulocyte Macrophage)|Combined use of G-CSF(Granulocyte Colony-Stimulating Factor ) and GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) (G-CSF 7.5 µg/kg / GM-CSF 7.5 µg/kg.)
1220966|NCT00208949|O1|Outcome|G-CSF (Granulocyte Colony- Stimulating Factor)|Single use of G-CSF(Granulocyte Colony-Stimulating Factor ) G-CSF 7.5 µg/kg twice a day
1220967|NCT00208949|E2|Reported Event|G-CSF and GM-CSF (Granulocyte Macrophage)|Combined use of G-CSF and GM-CSF
1220968|NCT00208949|E1|Reported Event|G-CSF (Granulocyte Colony- Stimulating Factor)|Single use of G-CSF
1220969|NCT00208767|B3|Baseline|Total|Total of all reporting groups
1220970|NCT00208767|B2|Baseline|Placebo|Patients received a placebo instead of Valsartan
1220971|NCT00208767|B1|Baseline|Valsartan|"Valsartan titrated up to 320 mg orally daily~Valsartan: Valsartan was titrated to a target dose of 320 mg orally daily"
1220972|NCT00208767|P2|Participant Flow|Placebo|Patients received a placebo instead of Valsartan
1220973|NCT00208767|P1|Participant Flow|Valsartan|"Valsartan titrated up to 320 mg orally daily~Valsartan: Valsartan was titrated to a target dose of 320 mg orally daily"
1220974|NCT00208767|O2|Outcome|Placebo|Patients received a placebo instead of Valsartan
1220975|NCT00208767|O1|Outcome|Valsartan|"Valsartan titrated up to 320 mg orally daily~Valsartan: Valsartan was titrated to a target dose of 320 mg orally daily"
1220976|NCT00208767|E2|Reported Event|Placebo|Patients received a placebo instead of Valsartan
1220977|NCT00208767|E1|Reported Event|Valsartan|"Valsartan titrated up to 320 mg orally daily~Valsartan: Valsartan was titrated to a target dose of 320 mg orally daily"
1220978|NCT00208507|B3|Baseline|Total|Total of all reporting groups
1220979|NCT00208507|B2|Baseline|Pinnacle™ Acetabular Cup With Marathon® Polyethylene|Pinnacle™ acetabular shells are a hemispherical type of acetabulum replacement prosthesis that incorporates Porocoat® porous coating for biologic fixation to host bone. The 28mm ceramic femoral heads were used with Marathon® polyethylene liners. The polyethylene insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
1220980|NCT00208507|B1|Baseline|Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup System|The Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis System consists of a modular ceramic bearing insert that attaches to a Pinnacle™ Acetabular Shell by a taper locking mechanism. The ceramic insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
1220981|NCT00208507|P2|Participant Flow|Pinnacle™ Acetabular Cup With Marathon® Polyethylene|Pinnacle™ acetabular shells are a hemispherical type of acetabulum replacement prosthesis that incorporates Porocoat® porous coating for biologic fixation to host bone. The 28mm ceramic femoral heads were used with Marathon® polyethylene liners. The polyethylene insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
1220982|NCT00208507|P1|Participant Flow|Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup System|The Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis System consists of a modular ceramic bearing insert that attaches to a Pinnacle™ Acetabular Shell by a taper locking mechanism. The ceramic insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
1220983|NCT00208507|O2|Outcome|Pinnacle™ Acetabular Cup With Marathon® Polyethylene|Pinnacle™ acetabular shells are a hemispherical type of acetabulum replacement prosthesis that incorporates Porocoat® porous coating for biologic fixation to host bone. The 28mm ceramic femoral heads were used with Marathon® polyethylene liners. The polyethylene insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
1220984|NCT00208507|O1|Outcome|Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup System|The Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis System consists of a modular ceramic bearing insert that attaches to a Pinnacle™ Acetabular Shell by a taper locking mechanism. The ceramic insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
1220985|NCT00208507|E2|Reported Event|Pinnacle™ Acetabular Cup With Marathon® Polyethylene|Pinnacle™ acetabular shells are a hemispherical type of acetabulum replacement prosthesis that incorporates Porocoat® porous coating for biologic fixation to host bone. The 28mm ceramic femoral heads were used with Marathon® polyethylene liners. The polyethylene insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
1220986|NCT00208507|E1|Reported Event|Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup System|The Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis System consists of a modular ceramic bearing insert that attaches to a Pinnacle™ Acetabular Shell by a taper locking mechanism. The ceramic insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
1220987|NCT00208494|B3|Baseline|Total|Total of all reporting groups
1220988|NCT00208494|B2|Baseline|Metal-on-Metal (MOM) Total Hip Implant|The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert.
1220989|NCT00208494|B1|Baseline|Ceramic-on-Metal (COM) Total Hip Implant|The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert.
1220990|NCT00208494|P2|Participant Flow|Metal-on-Metal (MOM) Total Hip Implant|The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert.
1220991|NCT00208494|P1|Participant Flow|Ceramic-on-Metal (COM) Total Hip Implant|The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert.
1220992|NCT00208494|O2|Outcome|Metal-on-Metal (MOM) Total Hip Implant|The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert.
1220993|NCT00208494|O1|Outcome|Ceramic-on-Metal (COM) Total Hip Implant|The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert.
1220994|NCT00208494|E2|Reported Event|Metal-on-Metal (MOM) Total Hip Implant|The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert.
1220995|NCT00208494|E1|Reported Event|Ceramic-on-Metal (COM) Total Hip Implant|The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert.
1220996|NCT00208325|B5|Baseline|Total|Total of all reporting groups
1220997|NCT00208325|B4|Baseline|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1220998|NCT00208325|B3|Baseline|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1220999|NCT00208325|B2|Baseline|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221000|NCT00208325|B1|Baseline|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221001|NCT00208325|P4|Participant Flow|PFC Mobile Bearing PCL Retained|"Mobile bearing~P.F.C Sigma Mobile Bearing Total knee system: Orthopaedic implant for total knee replacement"
1221002|NCT00208325|P3|Participant Flow|PFC Fixed Bearing PCL Retained|"Fixed bearing~P.F.C Sigma Fixed Bearing Total knee system: Orthopaedic implant for total knee replacement"
1221003|NCT00208325|P2|Participant Flow|PFC Mobile Bearing PCL Sacrificed|"Mobile bearing~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221004|NCT00208325|P1|Participant Flow|PFC Fixed Bearing PCL Sacrificed|"Fixed bearing~P.F.C Sigma Fixed Bearing Total knee system: Orthopaedic implant for total knee replacement"
1221005|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221006|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221007|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221008|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221009|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221010|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221011|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221012|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221013|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221014|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221015|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221016|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221017|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221018|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221019|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221020|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221021|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221022|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221023|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221024|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221025|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221026|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221027|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221028|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221029|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221030|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221031|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221032|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221033|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221034|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221035|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221036|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221037|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221038|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221039|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221139|NCT00207740|P4|Participant Flow|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
1221040|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221041|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221042|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221043|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221044|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221045|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221046|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221047|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221048|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221049|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221050|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221051|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221052|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221053|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221054|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221055|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221056|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221057|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221058|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221059|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221060|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221061|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221062|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221063|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221064|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221065|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221066|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221067|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221068|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221069|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221070|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221071|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221140|NCT00207740|P3|Participant Flow|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
1221072|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221073|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221074|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221075|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221076|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221077|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221078|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221079|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221080|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221081|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221082|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221083|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221084|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221085|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221086|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221087|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221088|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221089|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221090|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221091|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221092|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221093|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221094|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221095|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221096|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221097|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221098|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221099|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221100|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221101|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221102|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221103|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221141|NCT00207740|P2|Participant Flow|Group II: Golimumab 50 mg|Golimumab (CNTO148) 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
1221104|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221105|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221106|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221107|NCT00208325|E4|Reported Event|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221108|NCT00208325|E3|Reported Event|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221109|NCT00208325|E2|Reported Event|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
1221110|NCT00208325|E1|Reported Event|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
1221111|NCT00208091|B1|Baseline|Botulinum Toxin, Type B|Diluted botulinum toxin (500 Units/0.1 ml) is injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosage according to muscle(s) and symptom severity. Injection occurs at first visit only, after neurological evaluation.
1221112|NCT00208091|P1|Participant Flow|Botulinum Toxin, Type B|Diluted botulinum toxin (500 Units/0.1 ml) is injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosage according to muscle(s) and symptom severity. Injection occurs at first visit only, after neurological evaluation.
1221113|NCT00208091|O1|Outcome|Post-injection Subjective Change|Subjective assessment 6 weeks after diluted botulinum toxin (500 Units/0.1 ml) was injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosages varied for each patient according to symptom severity and involved muscle(s).
1221114|NCT00208091|O2|Outcome|Note Errors, Post-injection|Note errors (related to errors in loudness) 6 weeks after diluted botulinum toxin (500 Units/0.1 ml) was injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosages varied for each patient according to symptom severity and involved muscle(s).
1221115|NCT00208091|O1|Outcome|Note Errors, Baseline|Note errors (related to errors in loudness) were calculated as a measure of difference between the affected and unaffected hand performing multiple scale sequences of 8 to 16 notes. This was obtained by averaging sequences, note by note, for each hand and taking the square root of the mean of the square of the differences (root mean square error) in note loudness.
1221116|NCT00208091|O2|Outcome|Note Errors (Related to Errors in Duration), Post-injection|Note errors 6 weeks after diluted botulinum toxin (500 Units/0.1 ml) was injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosages varied for each patient according to symptom severity and involved muscle(s).
1221117|NCT00208091|O1|Outcome|Note Errors (Related to Errors in Duration), Baseline|Note errors (related to errors in duration) were calculated as measures of difference between the affected and unaffected hand performing multiple scale sequences of 8 to 16 notes played. This was obtained by averaging sequences, note by note, for each hand and taking the square root of the mean of the square of the differences (root mean square error) in note duration.
1221118|NCT00208091|E1|Reported Event|Botulinum Toxin, Type B|Diluted botulinum toxin (500 Units/0.1 ml) is injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosage according to muscle(s) and symptom severity. Injection occurs at first visit only, after neurological evaluation.
1221119|NCT00208026|B1|Baseline|Elidel (Pimecrolimus) 1% Cream|Treatment with drug/Elidel.Single arm-open-label treatment arm. A Pilot Study of the Efficacy and Safety of Pimecrolimus Cream 1% for the Treatment of Netherton Syndrome:
1221120|NCT00208026|P1|Participant Flow|Elidel (Pimecrolimus) 1% Cream|Treatment with drug/Elidel.Single arm-open-label treatment arm. A Pilot Study of the Efficacy and Safety of Pimecrolimus Cream 1% for the Treatment of Netherton Syndrome:
1221121|NCT00208026|O1|Outcome|Pimecrolimus 1% Cream|"Treatment with drug/Elidel. Single arm-open-label treatment arm. A Pilot Study of the Efficacy and Safety of Pimecrolimus Cream 1% for the Treatment of Netherton Syndrome:~Pimecrolimus 1% Cream: Open label single arm"
1221122|NCT00208026|E1|Reported Event|Elidel (Pimecrolimus) 1% Cream|Treatment with drug/Elidel.Single arm-open-label treatment arm. A Pilot Study of the Efficacy and Safety of Pimecrolimus Cream 1% for the Treatment of Netherton Syndrome:
1221123|NCT00207883|B3|Baseline|Total|Total of all reporting groups
1221124|NCT00207883|B2|Baseline|Group 2 - US|ultra sound assisted CVC placement
1221125|NCT00207883|B1|Baseline|Group 1 - LM|traditional anatomic landmark CVC placement utilizing palpation and the Seldinger technique
1221126|NCT00207883|P2|Participant Flow|Group 2 - Ultra Sound US|ultra sound assisted CVC placement
1221127|NCT00207883|P1|Participant Flow|Group 1 - Traditional Anatomic Landmark- LM|traditional anatomic landmark CVC placement utilizing palpation and the Seldinger technique
1221128|NCT00207883|O2|Outcome|Group 2 - US|ultra sound assisted CVC placement
1221129|NCT00207883|O1|Outcome|Group 1 - LM|traditional anatomic landmark CVC placement utilizing palpation and the Seldinger technique
1221130|NCT00207883|O2|Outcome|Group 2 - US|ultra sound assisted CVC placement
1221131|NCT00207883|O1|Outcome|Group 1 - LM|traditional anatomic landmark CVC placement utilizing palpation and the Seldinger technique
1221132|NCT00207883|E2|Reported Event|Group 2 - US|ultra sound assisted central line placement 10/118 (8.5%) had arterial puncture. None was considered serious.
1221133|NCT00207883|E1|Reported Event|Group 1 - LM|"traditional anatomic landmark central line placement utilizing palpation and the Seldinger technique.~18/93 (19.4%) had arterial puncture. None was considered serious."
1221134|NCT00207740|B5|Baseline|Total|Total of all reporting groups
1221135|NCT00207740|B4|Baseline|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
1221136|NCT00207740|B3|Baseline|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
1221142|NCT00207740|P1|Participant Flow|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
1221143|NCT00207740|O5|Outcome|Combined: Group III & IV|Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
1221144|NCT00207740|O4|Outcome|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
1221145|NCT00207740|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
1221146|NCT00207740|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
1221147|NCT00207740|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
1221148|NCT00207740|O5|Outcome|Combined: Group III & IV|Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
1221149|NCT00207740|O4|Outcome|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
1221150|NCT00207740|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
1221151|NCT00207740|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
1221152|NCT00207740|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from Wk 0 to Wk 52
1221153|NCT00207740|O5|Outcome|Combined: Group III & IV|Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
1221154|NCT00207740|O4|Outcome|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
1221155|NCT00207740|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
1221156|NCT00207740|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 75 milligram (mg) SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
1221157|NCT00207740|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from Wk 0 to Wk 52
1221158|NCT00207740|O5|Outcome|Combined: Group III & IV|Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
1221159|NCT00207740|O4|Outcome|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
1221160|NCT00207740|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
1221161|NCT00207740|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
1221162|NCT00207740|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
1221163|NCT00207740|O5|Outcome|Combined: Group III & IV|Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
1221164|NCT00207740|O4|Outcome|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
1221165|NCT00207740|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
1221166|NCT00207740|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 75 milligram (mg) SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
1221167|NCT00207740|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
1221168|NCT00207740|O5|Outcome|Combined: Group III & IV|Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
1221169|NCT00207740|O4|Outcome|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
1221170|NCT00207740|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
1221171|NCT00207740|O2|Outcome|Group II: Golimumab 50 mg|Golimumab (CNTO148) 75 milligram (mg) SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
1221172|NCT00207740|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
1221173|NCT00207740|O5|Outcome|Combined: Group III & IV|Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
1221174|NCT00207740|O4|Outcome|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
1221175|NCT00207740|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
1221176|NCT00207740|O2|Outcome|Group II: Golimumab 50 mg|Golimumab (CNTO148) 75 milligram (mg) SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
1221177|NCT00207740|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
1221178|NCT00207740|E4|Reported Event|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 wks to Wk 52
1221179|NCT00207740|E3|Reported Event|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 wks to Wk 52
1221180|NCT00207740|E2|Reported Event|Group II: Golimumab 50 mg|Golimumab (CNTO148) 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 wks to Wk 52
1221181|NCT00207740|E1|Reported Event|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 wks from Wk 0 to Wk 52
1221182|NCT00207727|B6|Baseline|Total|Total of all reporting groups
1221183|NCT00207727|B5|Baseline|Group V: Ustekinumab 180 mg Every 4 Weeks|Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
1221184|NCT00207727|B4|Baseline|Group IV: Ustekinumab 90 mg Every 4 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
1221185|NCT00207727|B3|Baseline|Group III: Ustekinumab 90 mg Every 8 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
1221186|NCT00207727|B2|Baseline|Group II: Ustekinumab 27 mg Every 4 Weeks|Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
1221187|NCT00207727|B1|Baseline|Group I: Placebo|Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
1221188|NCT00207727|P5|Participant Flow|Group V: Ustekinumab 180 mg Every 4 Weeks|Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
1221189|NCT00207727|P4|Participant Flow|Group IV: Ustekinumab 90 mg Every 4 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
1221190|NCT00207727|P3|Participant Flow|Group III: Ustekinumab 90 mg Every 8 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
1221191|NCT00207727|P2|Participant Flow|Group II: Ustekinumab 27 mg Every 4 Weeks|Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
1221192|NCT00207727|P1|Participant Flow|Group I: Placebo|Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
1221193|NCT00207727|O5|Outcome|Group V: Ustekinumab 180 mg Every 4 Weeks|Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
1221194|NCT00207727|O4|Outcome|Group IV: Ustekinumab 90 mg Every 4 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
1221195|NCT00207727|O3|Outcome|Group III: Ustekinumab 90 mg Every 8 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
1221279|NCT00207142|O2|Outcome|Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
1221196|NCT00207727|O2|Outcome|Group II: Ustekinumab 27 mg Every 4 Weeks|Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
1221197|NCT00207727|O1|Outcome|Group I: Placebo|Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
1221198|NCT00207727|O5|Outcome|Group V: Ustekinumab 180 mg Every 4 Weeks|Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
1221199|NCT00207727|O4|Outcome|Group IV: Ustekinumab 90 mg Every 4 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
1221200|NCT00207727|O3|Outcome|Group III: Ustekinumab 90 mg Every 8 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
1221201|NCT00207727|O2|Outcome|Group II: Ustekinumab 27 mg Every 4 Weeks|Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
1221202|NCT00207727|O1|Outcome|Group I: Placebo|Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
1221203|NCT00207727|O5|Outcome|Group V: Ustekinumab 180 mg Every 4 Weeks|Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
1221204|NCT00207727|O4|Outcome|Group IV: Ustekinumab 90 mg Every 4 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
1221205|NCT00207727|O3|Outcome|Group III: Ustekinumab 90 mg Every 8 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
1221206|NCT00207727|O2|Outcome|Group II: Ustekinumab 27 mg Every 4 Weeks|Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
1221207|NCT00207727|O1|Outcome|Group I: Placebo|Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
1221208|NCT00207727|E5|Reported Event|Group V: Ustekinumab 180 mg Every 4 Weeks|Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
1221209|NCT00207727|E4|Reported Event|Group IV: Ustekinumab 90 mg Every 4 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
1221210|NCT00207727|E3|Reported Event|Group III: Ustekinumab 90 mg Every 8 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
1221211|NCT00207727|E2|Reported Event|Group II: Ustekinumab 27 mg Every 4 Weeks|Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
1221212|NCT00207727|E1|Reported Event|Group I: Placebo|Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
1221213|NCT00207714|B6|Baseline|Total|Total of all reporting groups
1221214|NCT00207714|B5|Baseline|Group V: Golimumab 100 mg Every 2 or 4 Weeks|Golimumab 100 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group V: Golimumab 100 mg every 2 or 4 Wks.
1221215|NCT00207714|B4|Baseline|Group IV: Golibumab 100 mg Every 4 Weeks|Golimumab 100 mg SC injections every 4 Wks thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study. Also referred to as Group IV: golimumab 100 mg plus placebo every 4 Wks.
1221216|NCT00207714|B3|Baseline|Group III: Golimumab 50 mg Every 2 or 4 Weeks|Golimumab 50 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as GroupIII: Golimumab 50 mg every 2 or 4 Wks.
1221217|NCT00207714|B2|Baseline|Group II: Golimumab 50 mg Every 4 Weeks|Golimumab (CNTO148) 50 milligram (mg) SC injections every 4 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group II: golimumab 50 mg plus placebo every 4 Wks.
1221218|NCT00207714|B1|Baseline|Group I: Placebo Crossover to Infliximab|Placebo subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab intravenous (IV) infusions: 3 milligrams per kilogram (mg/kg) at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study.
1221219|NCT00207714|P5|Participant Flow|Group V: Golimumab 100 mg Every 2 or 4 Weeks|Golimumab 100 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group V: Golimumab 100 mg every 2 or 4 Wks.
1221269|NCT00207142|O2|Outcome|Nonrandomized Subjects|All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
1221220|NCT00207714|P4|Participant Flow|Group IV: Golibumab 100 mg Every 4 Weeks|Golimumab 100 mg SC injections every 4 Wks thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study. Also referred to as Group IV: golimumab 100 mg plus placebo every 4 Wks.
1221221|NCT00207714|P3|Participant Flow|Group III: Golimumab 50 mg Every 2 or 4 Weeks|Golimumab 50 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as GroupIII: Golimumab 50 mg every 2 or 4 Wks.
1221280|NCT00207142|O1|Outcome|Switch Regimen|ATV 400 mg QD + 2 NRTIs
1221281|NCT00207142|E3|Reported Event|Non-Randomized Participants|All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300mg + RTV 100mg QD + 2NRTIs)
1221222|NCT00207714|P2|Participant Flow|Group II: Golimumab 50 mg Every 4 Weeks|Golimumab (CNTO148) 50 milligram (mg) SC injections every 4 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group II: golimumab 50 mg plus placebo every 4 Wks.
1221223|NCT00207714|P1|Participant Flow|Group I: Placebo Crossover to Infliximab|Placebo subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab intravenous (IV) infusions: 3 milligrams per kilogram (mg/kg) at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study.
1221224|NCT00207714|O6|Outcome|Combined: Groups II, III, IV & V|Combines Groups II (golimumab 50 mg plus placebo), III (golimumab 50 mg every 2/4 wks), IV (golimumab 100 mg plus placebo) & V (golimumab 100 mg every 2/4 wks).
1221225|NCT00207714|O5|Outcome|Group V: Golimumab 100 mg Every 2 or 4 Weeks|Golimumab 100 mg SC injections every 2 wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 weeks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
1221226|NCT00207714|O4|Outcome|Group IV: Golibumab 100 mg Every 4 Weeks|Golimumab 100 mg SC injections every 4 wks thru Wk 18 plus MTX (Weeks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Weeks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study.
1221227|NCT00207714|O3|Outcome|Group III: Golimumab 50 mg Every 2 or 4 Weeks|Golimumab 50 mg SC injections every 2 wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 weeks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
1221228|NCT00207714|O2|Outcome|Group II: Golimumab 50 mg Every 4 Weeks|Golimumab (CNTO148) 50 mg SC injections every 4 wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
1221229|NCT00207714|O1|Outcome|Group I: Placebo Crossover to Infliximab|Placebo SC injections every 2 wks from Wk 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab IV infusions: 3 mg/kg at Wks 20, 22, 28 and then every 8 wks thru Wk 44. Continue stable dose of MTX throughout the study.
1221230|NCT00207714|O6|Outcome|Combined: Groups II, III, IV & V|Combines Groups II (golimumab 50 mg plus placebo), III (golimumab 50 mg every 2/4 Wks), IV (golimumab 100 mg plus placebo) & V (golimumab 100 mg every 2/4 Wks).
1221231|NCT00207714|O5|Outcome|Group V: Golimumab 100 mg Every 2 or 4 Weeks|Golimumab 100 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
1221232|NCT00207714|O4|Outcome|Group IV: Golibumab 100 mg Every 4 Weeks|Golimumab 100 mg SC injections every 4 Wks thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study.
1221233|NCT00207714|O3|Outcome|Group III: Golimumab 50 mg Every 2 or 4 Weeks|Golimumab 50 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
1221234|NCT00207714|O2|Outcome|Group II: Golimumab 50 mg Every 4 Weeks|Golimumab (CNTO148) 50 mg SC injections every 4 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
1221235|NCT00207714|O1|Outcome|Group I: Placebo Crossover to Infliximab|Placebo SC injections every 2 weeks (Wks) from week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab IV infusions: 3 mg/kg at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study.
1221236|NCT00207714|E5|Reported Event|Group V: Golimumab 100 mg Every 2 or 4 Weeks|Golimumab 100 milligrams (mg) subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Patients continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded thru the end of study. Also referred to as Group V: Golimumab 100 mg every 2 or 4 Wks.
1221270|NCT00207142|O1|Outcome|Randomized Subjects|All participants who were randomized at the end of Induction Phase to receive either Switch Regimen (ATV 400 mg QD + 2 NRTIs) or Continuation Regimen (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
1221271|NCT00207142|O2|Outcome|Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
1221237|NCT00207714|E4|Reported Event|Group IV: Golibumab 100 mg Every 4 Weeks|Golimumab 100 mg subcutaneous (SC) injections every 4 weeks (Wks) thru Week (Wk) 18 plus methotrexate (MTX) (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Patients continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded through the end of study. Also referred to as Group IV: golimumab 100 mg plus placebo every 4 Wks.
1221282|NCT00207142|E2|Reported Event|Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
1221283|NCT00207142|E1|Reported Event|Switch Regimen|ATV 400 mg QD + 2 NRTIs
1221392|NCT00206076|O2|Outcome|CNI Reduction|calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment
1221393|NCT00206076|O1|Outcome|CNI Discontinued|complete withdrawal of calcineurin inhibitors (CNI)
1221238|NCT00207714|E3|Reported Event|Group III: Golimumab 50 mg Every 2 or 4 Weeks|Golimumab 50 miligram (mg) subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Patients continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded thru the end of study. Also referred to as GroupIII: Golimumab 50 mg every 2 or 4 Wks.
1221239|NCT00207714|E2|Reported Event|Group II: Golimumab 50 mg Every 4 Weeks|Golimumab (CNTO148) 50 milligram (mg) subcutaneous (SC) injections every 4 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus methotrexate (MTX) (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Patients continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded thru the end of study. Also referred to as Group II: golimumab 50 mg plus placebo every 4 Wks.
1221240|NCT00207714|E1|Reported Event|Group I: Placebo Crossover to Infliximab|Placebo subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab intravenous (IV) infusions: 3 milligrams per kilogram (mg/kg) at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study.
1221241|NCT00207142|B4|Baseline|Total|Total of all reporting groups
1221242|NCT00207142|B3|Baseline|Nonrandomized Subjects|All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase: ATV 300 mg + RTV 100 mg QD + 2 NRTIs
1221243|NCT00207142|B2|Baseline|Randomized Subjects: Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
1221244|NCT00207142|B1|Baseline|Randomized Subjects: Switch Regimen|ATV 400 mg QD + 2 NRTIs
1221245|NCT00207142|P4|Participant Flow|Rescue Treatment|Participants without confirmed undetectable viral load at the end of Induction Phase were not randomized, but were offered to continue on ATV 300 mg + RTV 100 mg QD + 2 NRTIs for an additional 48 weeks (continued previous NRTI).
1221246|NCT00207142|P3|Participant Flow|Maintenance Treatment: Continuation Regimen|Participants with confirmed undetectable viral load (ie, HIV-1 RNA viral load < 50 c/mL on 2 consecutive on-treatment measurements performed from Week 16 up until Week 28 of the Induction Phase) at the end of Induction Phase, who were then randomized to ATV 300 mg + RTV 100 mg QD for an additional 48 weeks (continued previous NRTI).
1221247|NCT00207142|P2|Participant Flow|Maintenance Treatment: Switch Regimen|Participants with confirmed undetectable viral load (ie, HIV-1 RNA viral load < 50 c/mL on 2 consecutive on-treatment measurements performed from Week 16 up until Week 28 of the Induction Phase), at the end of Induction Phase, who were then randomized to ATV 400 mg QD for an additional 48 weeks (continued previous NRTI).
1221248|NCT00207142|P1|Participant Flow|Induction Treatment|Atazanavir (ATV) 300 mg + ritonavir (RTV) 100 mg, given once daily (QD) + 2 nucleoside reverse transcriptase inhibitors (NRTIs) during a 26- to 30-week Induction Phase
1221249|NCT00207142|O2|Outcome|Continuation Regimen|ATV 300mg + RTV 100mg QD + 2NRTIs
1221250|NCT00207142|O1|Outcome|Switch Regimen|ATV 400mg QD + 2NRTIs
1221251|NCT00207142|O1|Outcome|Rescue Treatment|Nonrandomized participants completing Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
1221252|NCT00207142|O2|Outcome|Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
1221253|NCT00207142|O1|Outcome|Switch Regimen|ATV 400 mg QD + 2 NRTIs
1221254|NCT00207142|O3|Outcome|Total|All participants treated with Induction Phase therapy (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
1221255|NCT00207142|O2|Outcome|Nonrandomized Subjects|All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
1221256|NCT00207142|O1|Outcome|Randomized Subjects|All participants who were randomized at the end of Induction Phase to receive either Switch Regimen (ATV 400 mg QD + 2 NRTIs) or Continuation Regimen (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
1221257|NCT00207142|O2|Outcome|Nonrandomized Subjects|All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300mg + RTV 100mg QD + 2NRTIs)
1221258|NCT00207142|O1|Outcome|Randomized Subjects|All participants who were randomized at the end of Induction Phase to receive either Switch Regimen (ATV 400mg QD + 2NRTIs) or Continuation Regimen (ATV 300mg + RTV 100mg QD + 2NRTIs)
1221259|NCT00207142|O2|Outcome|Nonrandomized Subjects|All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300mg + RTV 100mg QD + 2NRTIs)
1221260|NCT00207142|O1|Outcome|Randomized Subjects|All participants who were randomized at the end of Induction Phase to receive either Switch Regimen (ATV 400mg QD + 2NRTIs) or Continuation Regimen (ATV 300mg + RTV 100mg QD + 2NRTIs)
1221261|NCT00207142|O1|Outcome|Rescue Treatment|Nonrandomized participants completing Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
1221262|NCT00207142|O1|Outcome|Rescue Treatment|Nonrandomized participants completing Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
1221263|NCT00207142|O1|Outcome|Rescue Treatment|Nonrandomized participants completing Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
1221264|NCT00207142|O3|Outcome|Total|All participants treated with Induction Phase therapy (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
1221265|NCT00207142|O2|Outcome|Nonrandomized Subjects|All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
1221266|NCT00207142|O1|Outcome|Randomized Subjects|All participants who were randomized at the end of Induction Phase to receive either Switch Regimen (ATV 400 mg QD + 2 NRTIs) or Continuation Regimen (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
1221267|NCT00207142|O1|Outcome|Rescue Treatment|Nonrandomized participants completing Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
1221268|NCT00207142|O3|Outcome|Total|All participants treated with Induction Phase therapy (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
1221272|NCT00207142|O1|Outcome|Switch Regimen|ATV 400 mg QD + 2 NRTIs
1221273|NCT00207142|O2|Outcome|Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
1221274|NCT00207142|O1|Outcome|Switch Regimen|ATV 400 mg QD + 2 NRTIs
1221275|NCT00207142|O2|Outcome|Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
1221276|NCT00207142|O1|Outcome|Switch Regimen|ATV 400 mg QD + 2 NRTIs
1221277|NCT00207142|O2|Outcome|Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
1221278|NCT00207142|O1|Outcome|Switch Regimen|ATV 400 mg QD + 2 NRTIs
1221284|NCT00207090|B1|Baseline|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
1221285|NCT00207090|P1|Participant Flow|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
1221286|NCT00207090|O1|Outcome|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
1221287|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2.
1221288|NCT00207090|O1|Outcome|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
1221289|NCT00207090|O1|Outcome|Ixabepilone + Rifampin|Each participant was administered an oral dose of 600 mg of rifampin while in a fasted state on Day 22 (Cycle 2). Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2.
1221290|NCT00207090|O1|Outcome|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
1221291|NCT00207090|O1|Outcome|All Participants|All participants who were enrolled into the study, 24 hours before ixabepilone administration on Day -1. Each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2 on Day 1 of Cycle 1. Each participant was administered an oral dose of 600 mg of rifampin while in a fasted state on Day 22 (Cycle 2). Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23 through 28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food during Cycle 2.
1221313|NCT00206726|B1|Baseline|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
1221314|NCT00206726|P1|Participant Flow|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
1221292|NCT00207090|O2|Outcome|Ixabepilone + Rifampin|Having already received ixabepilone on Day 1 of Cycle 1 (see the “ixabepilone” treatment arm), participants were administered an oral dose of 600 mg rifampin on in the clinic on Day 15. On Days 16-21, participants self-administered rifampin once daily, at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
1221293|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. (Participants then proceeded through the rest of Cycle 1 and on to further cycles – see the “ixabepilone + rifampin” treatment arm).
1221294|NCT00207090|O1|Outcome|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
1221295|NCT00207090|O2|Outcome|Ixabepilone + Rifampin|Having already received ixabepilone on Day 1 of Cycle 1 (see the “ixabepilone” treatment arm), participants were administered an oral dose of 600 mg rifampin on in the clinic on Day 15. On Days 16-21, participants self-administered rifampin once daily, at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
1221296|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. (Participants then proceeded through the rest of Cycle 1 and on to further cycles – see the “ixabepilone + rifampin” treatment arm).
1221297|NCT00207090|O2|Outcome|Ixabepilone + Rifampin|Having already received ixabepilone on Day 1 of Cycle 1 (see the “ixabepilone” treatment arm), participants were administered an oral dose of 600 mg rifampin on in the clinic on Day 15. On Days 16-21, participants self-administered rifampin once daily, at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
1221298|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. (Participants then proceeded through the rest of Cycle 1 and on to further cycles – see the “ixabepilone + rifampin” treatment arm).
1221299|NCT00207090|O2|Outcome|Ixabepilone + Rifampin|Having already received ixabepilone on Day 1 of Cycle 1 (see the “ixabepilone” treatment arm), participants were administered an oral dose of 600 mg rifampin on in the clinic on Day 15. On Days 16-21, participants self-administered rifampin once daily, at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
1221300|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. (Participants then proceeded through the rest of Cycle 1 and on to further cycles – see the “ixabepilone + rifampin” treatment arm).
1221301|NCT00207090|O2|Outcome|Ixabepilone + Rifampin|Having already received ixabepilone on Day 1 of Cycle 1 (see the “ixabepilone” treatment arm), participants were administered an oral dose of 600 mg rifampin on in the clinic on Day 15. On Days 16-21, participants self-administered rifampin once daily, at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
1221302|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. (Participants then proceeded through the rest of Cycle 1 and on to further cycles – see the “ixabepilone + rifampin” treatment arm).
1221315|NCT00206726|O1|Outcome|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
1221316|NCT00206726|O1|Outcome|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
1221385|NCT00206076|B3|Baseline|Total|Total of all reporting groups
1221303|NCT00207090|O2|Outcome|Ixabepilone + Rifampin|Having already received ixabepilone on Day 1 of Cycle 1 (see the “ixabepilone” treatment arm), participants were administered an oral dose of 600 mg rifampin on in the clinic on Day 15. On Days 16-21, participants self-administered rifampin once daily, at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
1221304|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. (Participants then proceeded through the rest of Cycle 1 and on to further cycles – see the “ixabepilone + rifampin” treatment arm).
1221305|NCT00207090|O1|Outcome|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
1221306|NCT00207090|O1|Outcome|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
1221307|NCT00207090|O1|Outcome|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
1221308|NCT00207090|O2|Outcome|Ixabepilone + Rifampin|Having already received ixabepilone on Day 1 of Cycle 1 (see the “ixabepilone” treatment arm), participants were administered an oral dose of 600 mg rifampin on in the clinic on Day 15. On Days 16-21, participants self-administered rifampin once daily, at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
1221309|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. (Participants then proceeded through the rest of Cycle 1 and on to further cycles – see the “ixabepilone + rifampin” treatment arm).
1221310|NCT00207090|O2|Outcome|Ixabepilone + Rifampin|Having already received ixabepilone on Day 1 of Cycle 1 (see the “ixabepilone” treatment arm), participants were administered an oral dose of 600 mg rifampin on in the clinic on Day 15. On Days 16-21, participants self-administered rifampin once daily, at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
1221311|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. (Participants then proceeded through the rest of Cycle 1 and on to further cycles – see the “ixabepilone + rifampin” treatment arm).
1221312|NCT00207090|E1|Reported Event|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
1221317|NCT00206726|O1|Outcome|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
1221318|NCT00206726|O1|Outcome|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
1221319|NCT00206726|O1|Outcome|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
1221320|NCT00206726|O1|Outcome|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
1221321|NCT00206726|E1|Reported Event|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
1221322|NCT00206518|B3|Baseline|Total|Total of all reporting groups
1221678|NCT00205712|B3|Baseline|Total|Total of all reporting groups
1221323|NCT00206518|B2|Baseline|B: AC Adriamycin/Cytoxan|"In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.~Adriamycin/Cytoxan: Adriamycin/Cytoxan"
1221324|NCT00206518|B1|Baseline|A: Taxotere/Docetaxel|"Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.~Taxotere/Docetaxel: Taxotere~doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery."
1221325|NCT00206518|P2|Participant Flow|B: AC Adriamycin/Cytoxan|"In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.~Adriamycin/Cytoxan: Adriamycin/Cytoxan"
1221326|NCT00206518|P1|Participant Flow|A: Taxotere/Docetaxel|"Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.~Taxotere/Docetaxel: Taxotere~doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery."
1221327|NCT00206518|O2|Outcome|B: AC Adriamycin/Cytoxan|"In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.~Adriamycin/Cytoxan: Adriamycin/Cytoxan"
1221328|NCT00206518|O1|Outcome|A: Taxotere/Docetaxel|"Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.~Taxotere/Docetaxel: Taxotere~doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery."
1221329|NCT00206518|O2|Outcome|B: AC Adriamycin/Cytoxan|"In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.~Adriamycin/Cytoxan: Adriamycin/Cytoxan"
1221330|NCT00206518|O1|Outcome|A: Taxotere/Docetaxel|"Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.~Taxotere/Docetaxel: Taxotere~doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery."
1221331|NCT00206518|O2|Outcome|B: AC Adriamycin/Cytoxan|"In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.~Adriamycin/Cytoxan: Adriamycin/Cytoxan"
1221332|NCT00206518|O1|Outcome|A: Taxotere/Docetaxel|"Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.~Taxotere/Docetaxel: Taxotere~doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery."
1221382|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
1221383|NCT00206102|E2|Reported Event|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
1221384|NCT00206102|E1|Reported Event|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
1221333|NCT00206518|E2|Reported Event|B: AC Adriamycin/Cytoxan|"In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.~Adriamycin/Cytoxan: Adriamycin/Cytoxan"
1221389|NCT00206076|P1|Participant Flow|MMF, CNI Discontinued|Received Mycophenolate Mofetil (MMF); Complete withdrawal of calcineurin inhibitors (CNI)
1221390|NCT00206076|O2|Outcome|MMF; CNI Decreased|Received Mycophenolate Mofetil (MMF); calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment dosage
1221391|NCT00206076|O1|Outcome|MMF, CNI Discontinued|Received Mycophenolate Mofetil (MMF); Complete withdrawal of calcineurin inhibitors (CNI)
1221334|NCT00206518|E1|Reported Event|A: Taxotere/Docetaxel|"Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.~Taxotere/Docetaxel: Taxotere~doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery."
1221335|NCT00206440|B3|Baseline|Total|Total of all reporting groups
1221336|NCT00206440|B2|Baseline|Sugar Pill|Subjects will be given placebo(surgar pill) 40mg daily by mouth for Cycle 1 Days 1-5 and Cycle 2 Days 1-5.
1221337|NCT00206440|B1|Baseline|Esomeprazole|Subjects will be given esomeprazole 40mg daily by mouth for Cycle 1 Days 1-5 and Cycle 2 Days 1-5.
1221338|NCT00206440|P2|Participant Flow|Sugar Pill|Subjects will be given placebo(surgar pill) 40mg daily by mouth for Cycle 1 Days 1-5 and Cycle 2 Days 1-5.
1221339|NCT00206440|P1|Participant Flow|Esomeprazole|Subjects will be given esomeprazole 40mg daily by mouth for Cycle 1 Days 1-5 and Cycle 2 Days 1-5.
1221340|NCT00206440|O2|Outcome|Sugar Pill|The frist dose of sugar pill 40 mg will be administrated prior to the initiation of chemotherapy along with the standard antiemetics for each cycle. On day 2 to 5 following chemotherapy, the patient will take one capsule each morning.
1221341|NCT00206440|O1|Outcome|Esomeprazole|The first dose of esomeprazole 40 mg will be administrated prior to the initiation of chemotherapy along with the standard antiemetics for each cycle. On day 2 to 5 following chemotherapy, the patient will take one capsule each morning.
1221342|NCT00206440|E2|Reported Event|Sugar Pill|The frist dose of sugar pill 40 mg will be administrated prior to the initiation of chemotherapy along with the standard antiemetics for each cycle. On day 2 to 5 following chemotherapy, the patient will take one capsule each morning.
1221343|NCT00206440|E1|Reported Event|Esomeprazole|The frist dose of esomeprazole 40 mg will be administrated prior to the initiation of chemotherapy along with the standard antiemetics for each cycle. On day 2 to 5 following chemotherapy, the patient will take one capsule each morning.
1221344|NCT00206427|B1|Baseline|GW572016 1500mg|patients received GW572016 1500mg daily
1221345|NCT00206427|P1|Participant Flow|GW572016 1500mg|The study had only 1 treatment group and all patient had GW572016 1500mg daily.
1221346|NCT00206427|O1|Outcome|GW572016 1500mg|patients received GW572016 1500mg daily
1221347|NCT00206427|E1|Reported Event|GW572016 1500mg|patients received GW572016 1500mg daily
1221348|NCT00206102|B3|Baseline|Total|Total of all reporting groups
1221349|NCT00206102|B2|Baseline|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
1221350|NCT00206102|B1|Baseline|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
1221351|NCT00206102|P2|Participant Flow|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
1221352|NCT00206102|P1|Participant Flow|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
1221353|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
1221354|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
1221355|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
1221356|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
1221357|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
1221358|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
1221359|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
1221360|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
1221361|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
1221362|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
1221363|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
1221364|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
1221365|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
1221366|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
1221367|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
1221368|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
1221369|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
1221370|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
1221371|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
1221372|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
1221373|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
1221374|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
1221375|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
1221376|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
1221377|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
1221378|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
1221379|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
1221380|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
1221381|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
1221386|NCT00206076|B2|Baseline|MMF; CNI Decreased|Received Mycophenolate Mofetil (MMF); calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment dosage
1221387|NCT00206076|B1|Baseline|MMF, CNI Discontinued|Received Mycophenolate Mofetil (MMF); Complete withdrawal of calcineurin inhibitors (CNI)
1221388|NCT00206076|P2|Participant Flow|MMF; CNI Decreased|Received Mycophenolate Mofetil (MMF); calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment dosage
1221394|NCT00206076|O2|Outcome|MMF; CNI Decreased|Received Mycophenolate Mofetil (MMF); calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment dosage
1221395|NCT00206076|O1|Outcome|MMF, CNI Discontinued|Received Mycophenolate Mofetil (MMF); Complete withdrawal of calcineurin inhibitors (CNI)
1221396|NCT00206076|E2|Reported Event|MMF; CNI Decreased|Received Mycophenolate Mofetil (MMF); calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment dosage
1221397|NCT00206076|E1|Reported Event|MMF, CNI Discontinued|Received Mycophenolate Mofetil (MMF); Complete withdrawal of calcineurin inhibitors (CNI)
1221398|NCT00205881|B1|Baseline|Bilaterally Implanted|31 Subjects were bilaterally implanted with Bionic ear systems within the same surgery. 1 Subject was unilaterally implanted.
1221399|NCT00205881|P1|Participant Flow|Bilaterally Implanted|31 Subjects were bilaterally implanted with Bionic ear systems within the same surgery. 1 Subject was unilaterally implanted.
1221400|NCT00205881|O2|Outcome|8 Months Post-device Activation|Testing conducted with bilateral implants.
1221401|NCT00205881|O1|Outcome|Baseline|Testing with hearing aids in best-aided condition.
1221402|NCT00205881|E1|Reported Event|Bilaterally Implanted|31 Subjects were bilaterally implanted with Bionic ear systems within the same surgery. 1 Subject was unilaterally implanted.
1221403|NCT00205855|B1|Baseline|Spinal Cord Stimulation (SCS) Group|Precision Spinal Cord Stimulation therapy group
1221404|NCT00205855|P1|Participant Flow|Spinal Cord Stimulation (SCS) Group|"Upon meeting entry criteria and a baselineline evaluation all eligible subjects then receive either a temporary lead or a permanent lead (both leads are considered trial durign this phase) attached to an external stimulator for a minimum period of 48 hours. Patients who are determined to have 50% improvement in the VAS score from baseline after the trial phase were implanted with the Precision Spinal Cord Stimulation System."
1221405|NCT00205855|O1|Outcome|Spinal Cord Stimulation (SCS) Group|Precision Spinal Cord Stimulation therapy group
1221406|NCT00205855|E1|Reported Event|Spinal Cord Stimulation (SCS) Group|Precision Spinal Cord Stimulation therapy group
1221407|NCT00205803|B3|Baseline|Total|Total of all reporting groups
1221408|NCT00205803|B2|Baseline|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
1221409|NCT00205803|B1|Baseline|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
1221410|NCT00205803|P2|Participant Flow|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
1221411|NCT00205803|P1|Participant Flow|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
1221412|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
1221413|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
1221414|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
1221415|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
1221416|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
1221731|NCT00204932|P1|Participant Flow|Conjugated Linoleic Acid|4 grams per day of 78% CLA for 6 months
1221417|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
1221418|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
1221419|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
1221420|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
1221421|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
1221422|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
1221423|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series).
1221424|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
1221425|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
1221426|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
1221427|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
1221428|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
1221429|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
1221430|NCT00205803|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
1221431|NCT00205803|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
1221432|NCT00205803|O2|Outcome|7vPnC Before Toddler Dose|Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
1221433|NCT00205803|O1|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
1221434|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
1221435|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
1221436|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
1221467|NCT00205777|P6|Participant Flow|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221437|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
1221438|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
1221439|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
1221440|NCT00205803|O8|Outcome|7vPnC Toddler Dose|Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
1221441|NCT00205803|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
1221442|NCT00205803|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
1221443|NCT00205803|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
1221444|NCT00205803|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
1221445|NCT00205803|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
1221446|NCT00205803|O2|Outcome|7vPnc Dose 1|Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
1221447|NCT00205803|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
1221448|NCT00205803|O8|Outcome|7vPnC Toddler Dose|Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
1221449|NCT00205803|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
1221450|NCT00205803|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
1221451|NCT00205803|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
1221452|NCT00205803|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
1221453|NCT00205803|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
1221454|NCT00205803|O2|Outcome|7vPnc Dose 1|Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
1221455|NCT00205803|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
1221456|NCT00205803|E6|Reported Event|7vPnC 6-Month Follow-up|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
1221457|NCT00205803|E5|Reported Event|13vPnC 6-Month Follow-up|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
1221458|NCT00205803|E4|Reported Event|7vPnC Toddler Dose|Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
1221459|NCT00205803|E3|Reported Event|13vPnC Toddler Dose|Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
1221460|NCT00205803|E2|Reported Event|7vPnC Infant Series|Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
1221461|NCT00205803|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
1221462|NCT00205777|B5|Baseline|Total|Total of all reporting groups
1221463|NCT00205777|B4|Baseline|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221464|NCT00205777|B3|Baseline|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221465|NCT00205777|B2|Baseline|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221466|NCT00205777|B1|Baseline|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221732|NCT00204932|O2|Outcome|Placebo|3 grams per day of sunflower oil for 7 months
1221733|NCT00204932|O1|Outcome|Conjugated Linoleic Acid|3 grams per day for 7 months
1221468|NCT00205777|P5|Participant Flow|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221469|NCT00205777|P4|Participant Flow|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221470|NCT00205777|P3|Participant Flow|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221471|NCT00205777|P2|Participant Flow|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221472|NCT00205777|P1|Participant Flow|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 milligram (mg) capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221473|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221474|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221475|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221476|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221477|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221478|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221479|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221480|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221481|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221482|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221483|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221484|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221485|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221486|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221487|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221488|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221489|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221490|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221491|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221538|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221492|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221493|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221494|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221495|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221679|NCT00205712|B2|Baseline|Ketamine Plus Dexmedetomidine|ketamine infusion plus dexmedetomidine
1221496|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221497|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221498|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221499|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221500|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221501|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221502|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221503|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221504|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221505|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221506|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221507|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221508|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221509|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221510|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221511|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221512|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221513|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221514|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221734|NCT00204932|E2|Reported Event|Placebo|4 grams per day of sunflower oil for 6 months
1221735|NCT00204932|E1|Reported Event|Conjugated Linoleic Acid|4 grams of 78% active CLA per day for 6 months
1221515|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221516|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221517|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221518|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221519|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221520|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221521|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221522|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221523|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221524|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221525|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221526|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221527|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221528|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221529|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221530|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221531|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221532|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221533|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221534|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221535|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221536|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221537|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221853|NCT00203476|O1|Outcome|Niacin|Niacin added to max tolerated dose of statin
1221539|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221540|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221541|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221680|NCT00205712|B1|Baseline|Ketamine Alone|ketamine without dexmedetomidine
1221542|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221543|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221544|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221545|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221546|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221547|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221548|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221549|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221550|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221551|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221552|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221553|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221554|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221555|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221556|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221557|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221558|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221559|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221560|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221583|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221561|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221562|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221563|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221564|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221565|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221566|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221567|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221568|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221569|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221570|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221571|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221572|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221573|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221574|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221575|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221576|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221577|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221578|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221579|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221580|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221581|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221582|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221675|NCT00205777|E3|Reported Event|Raloxifene 60 mg (Core Study)|Raloxifene 60 mg capsule orally once daily in the core study along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221584|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221585|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221586|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221681|NCT00205712|P2|Participant Flow|Ketamine Plus Dexmedetomidine|Ketamine infusion plus dexmedetomidine
1235834|NCT00132808|B4|Baseline|Total|Total of all reporting groups
1221587|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221588|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221589|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221590|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221591|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221592|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221593|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221594|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221595|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221596|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221597|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221598|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221599|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221600|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221601|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221602|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221603|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221604|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221605|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221606|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1222198|NCT00201006|B4|Baseline|Total|Total of all reporting groups
1221607|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221608|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221609|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1238472|NCT00125515|O1|Outcome|Placebo|Placebo plus oral naltrexone
1221610|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221611|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221612|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221613|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221614|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221615|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221616|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221617|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221618|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221619|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221620|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221621|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221622|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221623|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221624|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221625|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221626|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221627|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221628|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221629|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1224836|NCT00187200|B3|Baseline|Total|Total of all reporting groups
1221630|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221631|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1240104|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE
1221632|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221633|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221634|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221635|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221636|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221637|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221638|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221639|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221640|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221641|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221642|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221643|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221644|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221645|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221646|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221647|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221648|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221649|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221650|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221651|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221729|NCT00204932|B1|Baseline|Conjugated Linoleic Acid|3 grams per day for 7 months
1221652|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221653|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221682|NCT00205712|P1|Participant Flow|Ketamine Alone|Ketamine without dexmedetomidine
1221683|NCT00205712|O2|Outcome|Ketamine Plus Dexmedetomidine|Ketamine infusion with dexmedetomidine
1221654|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221655|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221656|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221657|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221658|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221659|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221660|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221661|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221662|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221663|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221664|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221665|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221666|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221667|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221668|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221669|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221670|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221671|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221672|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221673|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
1221674|NCT00205777|E4|Reported Event|Placebo|Matching placebo capsule orally once daily along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily in the core study, study extension I and II.
1221730|NCT00204932|P2|Participant Flow|Placebo|4 grams per day of sunflower oil for 6 months
1221676|NCT00205777|E2|Reported Event|Bazedoxifene 40/ 20 mg|Bazedoxifene acetate 40 mg capsule orally once daily in the core study, in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, and II along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
1221677|NCT00205777|E1|Reported Event|Bazedoxifene 20 mg|Bazedoxifene acetate 20 mg capsule orally once daily along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily in core study, study extension I and II.
1221684|NCT00205712|O1|Outcome|Ketamine Alone|Ketamine without dexmedetomidine
1221685|NCT00205712|O2|Outcome|Ketamine Plus Dexmedetomidine|Ketamine infusion with dexmedetomidine
1221686|NCT00205712|O1|Outcome|Ketamine Alone|Ketamine without dexmedetomidine
1221687|NCT00205712|O2|Outcome|Ketamine Plus Dexmedetomidine|ketamine infusion plus dexmedetomidine
1221688|NCT00205712|O1|Outcome|Ketamine Alone|ketamine without dexmedetomidine
1221689|NCT00205712|E2|Reported Event|Ketamine Plus Dexmedetomidine|Ketamine infusion with dexmedetomidine
1221690|NCT00205712|E1|Reported Event|Ketamine Alone|Ketamine without dexmedetomidine
1221691|NCT00205504|B3|Baseline|Total|Total of all reporting groups
1221692|NCT00205504|B2|Baseline|Lean Women|Women with Body Mass Index)BMI <25 kg/m²
1221693|NCT00205504|B1|Baseline|Obese Women|"Women with Body Mass Index (BMI) >30 kg/m².~Note: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use."
1221694|NCT00205504|P2|Participant Flow|Lean Women|Women with Body Mass Index)BMI <25 kg/m²
1221695|NCT00205504|P1|Participant Flow|Obese Women|"Women with Body Mass Index (BMI) >30 kg/m².~Note: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use."
1221696|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index (BMI) <25 kg/m²
1221697|NCT00205504|O1|Outcome|Obese Women|Women with Body Mass Index (BMI) >30 kg/m²
1221698|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index (BMI) <25 kg/m²
1221699|NCT00205504|O1|Outcome|Obese Women|Women with Body Mass Index (BMI) >30 kg/m²
1221700|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index (BMI) <25 kg/m²
1221701|NCT00205504|O1|Outcome|Obese Women|Women with Body Mass Index (BMI) >30 kg/m²
1221702|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index)BMI <25 kg/m²
1221703|NCT00205504|O1|Outcome|Obese Women|"Women with Body Mass Index (BMI) >30 kg/m².~Note: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use."
1221704|NCT00205504|O2|Outcome|Lean Women|Women with BMI >25 kg/m²
1221705|NCT00205504|O1|Outcome|Obese Women|Women with BMI >30 kg/m²
1221706|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index (BMI) <25 kg/m²
1221707|NCT00205504|O1|Outcome|Obese Women|Women with Body Mass Index (BMI) >30 kg/m²
1221708|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index)BMI <25 kg/m²
1221709|NCT00205504|O1|Outcome|Obese Women|"Women with Body Mass Index (BMI) >30 kg/m².~Note: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use."
1221710|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index (BMI) <25 kg/m²
1221711|NCT00205504|O1|Outcome|Obese Women|Women with Body Mass Index (BMI) >30 kg/m²
1221712|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index (BMI) <25 kg/m²
1221713|NCT00205504|O1|Outcome|Obese Women|Women with Body Mass Index (BMI) >30 kg/m²
1221714|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index (BMI) <25 kg/m²
1221715|NCT00205504|O1|Outcome|Obese Women|Women with Body Mass Index (BMI) >30 kg/m²
1221716|NCT00205504|E2|Reported Event|Lean Women|Women with Body Mass Index)BMI <25 kg/m²
1221717|NCT00205504|E1|Reported Event|Obese Women|"Women with Body Mass Index (BMI) >30 kg/m².~Note: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use."
1221718|NCT00205049|B3|Baseline|Total|Total of all reporting groups
1221719|NCT00205049|B2|Baseline|Placebo|All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days
1221720|NCT00205049|B1|Baseline|Pentoxifylline|All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days
1221721|NCT00205049|P2|Participant Flow|Placebo|All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days
1221722|NCT00205049|P1|Participant Flow|Pentoxifylline|All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days
1221723|NCT00205049|O2|Outcome|Placebo|
1221724|NCT00205049|O1|Outcome|Pentoxifylline|
1221725|NCT00205049|E2|Reported Event|Placebo|
1221726|NCT00205049|E1|Reported Event|Pentoxifylline|
1221727|NCT00204932|B3|Baseline|Total|Total of all reporting groups
1221728|NCT00204932|B2|Baseline|Placebo|3 grams per day of sunflower oil for 7 months
1221736|NCT00204373|B1|Baseline|Single Group|This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
1221737|NCT00204373|P1|Participant Flow|Single Group|This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
1221738|NCT00204373|O1|Outcome|Single Group|This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
1221863|NCT00203476|E3|Reported Event|Ezetimibe|Ezetimibe added to max tolerated dose statin
1221864|NCT00203476|E2|Reported Event|Colestipol|Colestipol added to max dose statin
1221739|NCT00204373|O1|Outcome|Single Group|This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
1221740|NCT00204373|E1|Reported Event|Single Group|This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
1221741|NCT00203996|B7|Baseline|Total|Total of all reporting groups
1221742|NCT00203996|B6|Baseline|Aim 3: All Participants|Includes groups randomized to any experimental ordering in Aim 3
1221743|NCT00203996|B5|Baseline|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
1221744|NCT00203996|B4|Baseline|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
1221745|NCT00203996|B3|Baseline|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
1221746|NCT00203996|B2|Baseline|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
1221747|NCT00203996|B1|Baseline|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
1221748|NCT00203996|P10|Participant Flow|Aim 3: Baseline - SWS Supp - REM Frag|"Each subject was assessed under three experimental conditions in the following order.~Baseline: Baseline sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention.~SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.~REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed."
1221749|NCT00203996|P9|Participant Flow|Aim 3: SWS Supp - REM Frag - Baseline|"Each subject was assessed under three experimental conditions in the following order.~SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.~REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.~Baseline: Baseline sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention."
1221750|NCT00203996|P8|Participant Flow|Aim 3: Baseline - REM Frag - SWS Supp|"Each subject was assessed under three experimental conditions in the following order.~Baseline: Baseline sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention.~REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.~SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed."
1221751|NCT00203996|P7|Participant Flow|Aim 3: REM Frag - Baseline - SWS Supp|"Each subject was assessed under three experimental conditions in the following order.~REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.~Baseline: Baseline sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention.~SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed."
1221752|NCT00203996|P6|Participant Flow|Aim 3: REM Frag - SWS Supp - Baseline|"Each subject was assessed under three experimental conditions in the following order.~REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.~SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.~Baseline: Baseline sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention."
1221753|NCT00203996|P5|Participant Flow|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
1221754|NCT00203996|P4|Participant Flow|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
1221755|NCT00203996|P3|Participant Flow|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
1221756|NCT00203996|P2|Participant Flow|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
1221757|NCT00203996|P1|Participant Flow|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
1221758|NCT00203996|O2|Outcome|Aim 3: SWS Suppression|Slow wave sleep (SWS) suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.
1221759|NCT00203996|O1|Outcome|Aim 3: REM Fragmentation|Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.
1221760|NCT00203996|O2|Outcome|Aim 3: SWS Suppression|Slow wave sleep (SWS) suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.
1221761|NCT00203996|O1|Outcome|Aim 3: REM Fragmentation|Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.
1221762|NCT00203996|O2|Outcome|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
1221865|NCT00203476|E1|Reported Event|Niacin|Niacin added to max tolerated dose of statin
1221866|NCT00203424|B1|Baseline|Erlotinib + Bevacizumab|Participants that entered treatment period.
1221763|NCT00203996|O1|Outcome|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
1221764|NCT00203996|O2|Outcome|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
1221765|NCT00203996|O1|Outcome|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
1221766|NCT00203996|O2|Outcome|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
1221767|NCT00203996|O1|Outcome|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
1221768|NCT00203996|O2|Outcome|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
1221769|NCT00203996|O1|Outcome|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
1221770|NCT00203996|O2|Outcome|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
1221771|NCT00203996|O1|Outcome|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
1221772|NCT00203996|O2|Outcome|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
1221773|NCT00203996|O1|Outcome|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
1221774|NCT00203996|O3|Outcome|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
1221775|NCT00203996|O2|Outcome|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
1221776|NCT00203996|O1|Outcome|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
1221777|NCT00203996|O3|Outcome|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
1221778|NCT00203996|O2|Outcome|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
1221779|NCT00203996|O1|Outcome|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
1221780|NCT00203996|O3|Outcome|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
1221781|NCT00203996|O2|Outcome|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
1221782|NCT00203996|O1|Outcome|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
1221783|NCT00203996|O3|Outcome|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
1221784|NCT00203996|O2|Outcome|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
1221785|NCT00203996|O1|Outcome|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
1221786|NCT00203996|O2|Outcome|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
1221787|NCT00203996|O1|Outcome|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
1221788|NCT00203996|O2|Outcome|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
1221789|NCT00203996|O1|Outcome|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
1221790|NCT00203996|O3|Outcome|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
1221791|NCT00203996|O2|Outcome|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
1221792|NCT00203996|O1|Outcome|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
1221793|NCT00203996|O3|Outcome|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
1221794|NCT00203996|O2|Outcome|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
1221795|NCT00203996|O1|Outcome|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
1221796|NCT00203996|E7|Reported Event|Aim 3: SWS Suppression|SWS: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.
1221797|NCT00203996|E6|Reported Event|Aim 3: REM Fragmentation|Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.
1221956|NCT00203047|B1|Baseline|GA + Placebo|Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
1221798|NCT00203996|E5|Reported Event|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
1221799|NCT00203996|E4|Reported Event|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
1221800|NCT00203996|E3|Reported Event|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
1221801|NCT00203996|E2|Reported Event|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
1221802|NCT00203996|E1|Reported Event|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
1221803|NCT00203931|B3|Baseline|Total|Total of all reporting groups
1221804|NCT00203931|B2|Baseline|Cetuximab and Pemetrexed|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
1221805|NCT00203931|B1|Baseline|Cetuximab|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
1221806|NCT00203931|P2|Participant Flow|Cetuximab and Pemetrexed|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
1221807|NCT00203931|P1|Participant Flow|Cetuximab|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
1221808|NCT00203931|O2|Outcome|Good Prognosis|"VeriStrat assigned classification based on mass spectrometry-based assay of serum samples collect at baseline. Details of how this was done is provided in Mass spectrometry to classify non-small-cell lung cancer patients for clinical outcome after treatment with epidermal growth factor receptor tyrosine kinase inhibitors: a multicohort cross-institutional study. by Taguchi et al. in J Natl Cancer Inst 2007 99(11): 838-46."
1221809|NCT00203931|O1|Outcome|Poor Prognosis|"VeriStrat assigned classification based on mass spectrometry-based assay of serum samples collect at baseline. Details of how this was done is provided in Mass spectrometry to classify non-small-cell lung cancer patients for clinical outcome after treatment with epidermal growth factor receptor tyrosine kinase inhibitors: a multicohort cross-institutional study. by Taguchi et al. in J Natl Cancer Inst 2007 99(11): 838-46."
1221810|NCT00203931|O2|Outcome|Cetuximab and Pemetrexed|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
1221811|NCT00203931|O1|Outcome|Cetuximab|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
1221812|NCT00203931|O2|Outcome|Cetuximab and Pemetrexed|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
1221813|NCT00203931|O1|Outcome|Cetuximab|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
1221814|NCT00203931|O2|Outcome|No Early Rash|Absence of rash (grade 1 or higher) by day 21 of cetuximab therapy
1221815|NCT00203931|O1|Outcome|Early Rash|Presence of rash (grade 1 or higher) by day 21 of cetuximab therapy
1221816|NCT00203931|O2|Outcome|Cetuximab and Pemetrexed|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
1221817|NCT00203931|O1|Outcome|Cetuximab|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
1221818|NCT00203931|E2|Reported Event|Cetuximab and Pemetrexed|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
1221819|NCT00203931|E1|Reported Event|Cetuximab|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
1221820|NCT00203892|B4|Baseline|Total|Total of all reporting groups
1221821|NCT00203892|B3|Baseline|C: CEA Peptide 1000mcg|Vaccine contained the modified CEA peptide (1000mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
1221822|NCT00203892|B2|Baseline|B: CEA Peptide 100 mcg|Vaccine contained the modified CEA peptide (100mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
1221823|NCT00203892|B1|Baseline|A: CEA Peptide 10mcg|Vaccine contained the modified CEA peptide (10mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
1221824|NCT00203892|P3|Participant Flow|C: CEA Peptide 1000mcg|Vaccine contained the modified CEA peptide (1000mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
1221854|NCT00203476|O3|Outcome|Ezetimibe|Ezetimibe added to max tolerated dose statin
1221855|NCT00203476|O2|Outcome|Colestipol|Colestipol added to max dose statin
1227894|NCT00168805|E1|Reported Event|Dabigatran 220mg|qd (once daily) oral
1221825|NCT00203892|P2|Participant Flow|B: CEA Peptide 100 mcg|Vaccine contained the modified CEA peptide (100mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
1221826|NCT00203892|P1|Participant Flow|A: CEA Peptide 10mcg|Vaccine contained the modified CEA peptide (10mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
1221827|NCT00203892|O3|Outcome|C: CEA Peptide 1000mcg|Vaccine contained the modified CEA peptide (1000mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
1221828|NCT00203892|O2|Outcome|B: CEA Peptide 100 mcg|Vaccine contained the modified CEA peptide (100mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
1221829|NCT00203892|O1|Outcome|A: CEA Peptide 10mcg|Vaccine contained the modified CEA peptide (10mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
1221830|NCT00203892|O3|Outcome|C: CEA Peptide 1000mcg|Vaccine contained the modified CEA peptide (1000mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
1221831|NCT00203892|O2|Outcome|B: CEA Peptide 100 mcg|Vaccine contained the modified CEA peptide (100mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
1221832|NCT00203892|O1|Outcome|A: CEA Peptide 10mcg|Vaccine contained the modified CEA peptide (10mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
1221833|NCT00203892|E3|Reported Event|C: CEA Peptide 1000mcg|Vaccine contained the modified CEA peptide (1000mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
1221834|NCT00203892|E2|Reported Event|B: CEA Peptide 100 mcg|Vaccine contained the modified CEA peptide (100mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
1221835|NCT00203892|E1|Reported Event|A: CEA Peptide 10mcg|Vaccine contained the modified CEA peptide (10mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
1221836|NCT00203502|B1|Baseline|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2~+ Avastin 15 mg/kg~Q 3 weeks X 4 cycles~Bevacizumab/Avastin: IV 15mg/kg 21 days~Cyclophosphamide: 500mg per meter squared, IV every 21 days~Doxorubicin: 60 mg per meter squared, IV every 21 days"
1221837|NCT00203502|P1|Participant Flow|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2~+ Avastin 15 mg/kg~Q 3 weeks X 4 cycles~Bevacizumab/Avastin: IV 15mg/kg 21 days~Cyclophosphamide: 500mg per meter squared, IV every 21 days~Doxorubicin: 60 mg per meter squared, IV every 21 days"
1221838|NCT00203502|O1|Outcome|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2~+ Avastin 15 mg/kg~Q 3 weeks X 4 cycles~Bevacizumab/Avastin: IV 15mg/kg 21 days~Cyclophosphamide: 500mg per meter squared, IV every 21 days~Doxorubicin: 60 mg per meter squared, IV every 21 days"
1221839|NCT00203502|O1|Outcome|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2~+ Avastin 15 mg/kg~Q 3 weeks X 4 cycles~Bevacizumab/Avastin: IV 15mg/kg 21 days~Cyclophosphamide: 500mg per meter squared, IV every 21 days~Doxorubicin: 60 mg per meter squared, IV every 21 days"
1221840|NCT00203502|O1|Outcome|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2~+ Avastin 15 mg/kg~Q 3 weeks X 4 cycles~Bevacizumab/Avastin: IV 15mg/kg 21 days~Cyclophosphamide: 500mg per meter squared, IV every 21 days~Doxorubicin: 60 mg per meter squared, IV every 21 days"
1221841|NCT00203502|O1|Outcome|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2~+ Avastin 15 mg/kg~Q 3 weeks X 4 cycles~Bevacizumab/Avastin: IV 15mg/kg 21 days~Cyclophosphamide: 500mg per meter squared, IV every 21 days~Doxorubicin: 60 mg per meter squared, IV every 21 days"
1221842|NCT00203502|O1|Outcome|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2~+ Avastin 15 mg/kg~Q 3 weeks X 4 cycles~Bevacizumab/Avastin: IV 15mg/kg 21 days~Cyclophosphamide: 500mg per meter squared, IV every 21 days~Doxorubicin: 60 mg per meter squared, IV every 21 days"
1221843|NCT00203502|E1|Reported Event|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2~+ Avastin 15 mg/kg~Q 3 weeks X 4 cycles~Bevacizumab/Avastin: IV 15mg/kg 21 days~Cyclophosphamide: 500mg per meter squared, IV every 21 days~Doxorubicin: 60 mg per meter squared, IV every 21 days"
1221844|NCT00203476|B4|Baseline|Total|Total of all reporting groups
1221845|NCT00203476|B3|Baseline|Ezetimibe|Ezetimibe added to max tolerated dose statin
1221846|NCT00203476|B2|Baseline|Colestipol|Colestipol added to max dose statin
1221847|NCT00203476|B1|Baseline|Niacin|Niacin added to max tolerated dose of statin
1221848|NCT00203476|P3|Participant Flow|Ezetimibe|Ezetimibe added to max tolerated dose statin
1221849|NCT00203476|P2|Participant Flow|Colestipol|Colestipol added to max dose statin
1221850|NCT00203476|P1|Participant Flow|Niacin|Niacin added to max tolerated dose of statin
1221851|NCT00203476|O3|Outcome|Ezetimibe|Ezetimibe added to max tolerated dose statin
1221852|NCT00203476|O2|Outcome|Colestipol|Colestipol added to max dose statin
1221856|NCT00203476|O1|Outcome|Niacin|Niacin added to max tolerated dose of statin
1221857|NCT00203476|O3|Outcome|Ezetimibe|Ezetimibe added to max tolerated dose statin
1221858|NCT00203476|O2|Outcome|Colestipol|Colestipol added to max dose statin
1221859|NCT00203476|O1|Outcome|Niacin|Niacin added to max tolerated dose of statin
1221860|NCT00203476|O3|Outcome|Ezetimibe|Ezetimibe added to max tolerated dose statin
1221861|NCT00203476|O2|Outcome|Colestipol|Colestipol added to max dose statin
1221862|NCT00203476|O1|Outcome|Niacin|Niacin added to max tolerated dose of statin
1221867|NCT00203424|P1|Participant Flow|Erlotinib + Bevacizumab|27 participants were screened for the study. 4 did not meet eligibility criteria,23 were registered to treatment period. 1 withdrew consent a day after registration and did not initiate study treatment.22 participants entered treatment period. Participants received Erlotinib every day for 24 weeks and Bevacizumab every 3 weeks for a total of 8 doses. The protocol instructed that pts be treated for 6 cycles. Of the 22 pts that started treatment, 11 completed the 6 cycles and the other 11 had to stop treatment prior to administration of 6th cycle. Of the 11 pts that did not complete all 6 cycles, 5 stopped treatment due to adverse event and were entered into the follow-up period. The 6 that stopped treatment due to withdrawal of consent and progressive disease did not enter the follow-up period. So 11 pts that completed 6 cycles of treatment plus 5 pts that did not complete 6 cycles of treatment due to an adverse event gives a total of 16 patients who entered follow-up period.
1221868|NCT00203424|O1|Outcome|Bevacizumab+Erlotinib|
1221869|NCT00203424|O1|Outcome|Bevacizumab+Erlotinib|
1221870|NCT00203424|O1|Outcome|Bevacizumab+Erlotinib|
1221871|NCT00203424|O1|Outcome|Bevacizumab+Erlotinib|
1221872|NCT00203424|E1|Reported Event|Erlotinib + Bevacizumab|Participants that entered treatment period.
1221873|NCT00203411|B1|Baseline|Bevacizumab Plus Capecitabine|Bevacizumab 7.5 mg/kg every 3 weeks will be administered interavenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
1221874|NCT00203411|P1|Participant Flow|Bevacizumab Plus Capecitabine|"Bevacizumab 7.5 mg/kg every 3 weeks will be administered interavenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.~Capecitabine (Xeloda): 1000mg/m2 administered orally twice daily for two weeks followed by one week rest period~Bevacizumab: 7.5 mg/kg IV will be administered every 3 weeks"
1221875|NCT00203411|O1|Outcome|Bevacizumab Plus Capecitabine|Bevacizumab 7.5 mg/kg every 3 weeks will be administered intravenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
1221876|NCT00203411|O1|Outcome|Bevacizumab Plus Capecitabine|Bevacizumab 7.5 mg/kg every 3 weeks will be administered intravenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
1221877|NCT00203411|O1|Outcome|Bevacizumab Plus Capecitabine|Bevacizumab 7.5 mg/kg every 3 weeks will be administered intravenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
1221878|NCT00203411|O1|Outcome|Bevacizumab Plus Capecitabine|Bevacizumab 7.5 mg/kg every 3 weeks will be administered intravenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
1221879|NCT00203411|E1|Reported Event|Bevacizumab Plus Capecitabine|Bevacizumab 7.5 mg/kg every 3 weeks will be administered intravenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
1221880|NCT00203307|B3|Baseline|Total|Total of all reporting groups
1221881|NCT00203307|B2|Baseline|Placebo First, Then Olanzapine|Matching placebo during first intervention period, then olanzapine (5-10 mg. daily) during second intervention period (after washout period).
1221882|NCT00203307|B1|Baseline|Olanzapine First, Then Placeb|Olanzapine (5-10 mg daily) during first intervention period and matching placebo in second intervention period (after washout period)
1221883|NCT00203307|P2|Participant Flow|Placebo First, Then Olanzapine|Matching placebo during first intervention period, then olanzapine (5-10 mg. daily) during second intervention period (after washout period).
1221884|NCT00203307|P1|Participant Flow|Olanzapine First, Then Placeb|Olanzapine (5-10 mg daily) during first intervention period and matching placebo in second intervention period (after washout period)
1221885|NCT00203307|O2|Outcome|Placebo First, Then Olanzapine|Matching placebo during first intervention period, then olanzapine (5-10 mg. daily) during second intervention period (after washout period).
1221886|NCT00203307|O1|Outcome|Olanzapine First, Then Placeb|Olanzapine (5-10 mg daily) during first intervention period and matching placebo in second intervention period (after washout period)
1221887|NCT00203307|E2|Reported Event|Placebo First, Then Olanzapine|Matching placebo during first intervention period, then olanzapine (5-10 mg. daily) during second intervention period (after washout period).
1221888|NCT00203307|E1|Reported Event|Olanzapine First, Then Placeb|Olanzapine (5-10 mg daily) during first intervention period and matching placebo in second intervention period (after washout period)
1221889|NCT00203294|B3|Baseline|Total|Total of all reporting groups
1221890|NCT00203294|B2|Baseline|GON Block Plus Steroid|Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus triamcinolone 40 mg. Two cc were injected to each GON and 0.5 cc to each trigger point, to a total injected volume of 10 cc.
1221891|NCT00203294|B1|Baseline|GON Block Only|Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus saline. Two cc were injected to each GON (greater occipital nerve) and 0.5 cc to each trigger point, to a total injected volume of 10 cc.
1221892|NCT00203294|P2|Participant Flow|GON Block Plus Steroid|Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus triamcinolone 40 mg. Two cc were injected to each GON and 0.5 cc to each trigger point, to a total injected volume of 10 cc.
1221893|NCT00203294|P1|Participant Flow|GON Block Only|Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus saline. Two cc were injected to each GON (greater occipital nerve) and 0.5 cc to each trigger point, to a total injected volume of 10 cc.
1221894|NCT00203294|O2|Outcome|Lidocaine 2% and Bupivacaine 0.25% Plus Triamcinolone 40 mg.|Adult patients with Chronic Daily Headache (CDH), and headache of at least moderate intensity at time of treatment, were randomized to receive bilateral GONB and 12 trigger point injections
1221895|NCT00203294|O1|Outcome|Lidocaine 2% and Bupivacaine 0.25% Plus Saline|Adult patients with Chronic Daily Headache (CDH), and headache of at least moderate intensity at time of treatment, were randomized to receive bilateral GONB and 12 trigger point injections
1221896|NCT00203294|E2|Reported Event|GON Block Plus Steroid|Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus triamcinolone 40 mg. Two cc were injected to each GON and 0.5 cc to each trigger point, to a total injected volume of 10 cc.
1221897|NCT00203294|E1|Reported Event|GON Block Only|Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus saline. Two cc were injected to each GON (greater occipital nerve) and 0.5 cc to each trigger point, to a total injected volume of 10 cc.
1221898|NCT00203268|B1|Baseline|Treatment Group|Subjects who treated a moderate to severe migraine 2 hours and 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe.
1221899|NCT00203268|P1|Participant Flow|Treatment Group|Subjects who treated a moderate to severe migraine at 1 hour and at 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. intramuscular (IM). Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe
1221900|NCT00203268|O2|Outcome|Late Treatment|Subjects who treated a moderate to severe migraine 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe
1221901|NCT00203268|O1|Outcome|Early Treatment|Subjects who treated a moderate to severe migraine 2 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe.
1221902|NCT00203268|E2|Reported Event|Late Treatment|Subjects who treated a moderate to severe migraine 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe
1221903|NCT00203268|E1|Reported Event|Early Treatment|Subjects who treated a moderate to severe migraine 2 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe.
1221904|NCT00203242|B1|Baseline|Depacon IV and Depakote|Subjects will be treated with 2 consecutive days of IV Depacon (1000 mg/day) followed by oral Depakote ER (1000 mg/day). Subject continues oral Depakote ER until end of cluster cycle or for a maximum of 6 weeks, which ever comes first.
1221905|NCT00203242|P1|Participant Flow|Depacon IV and Depakote|Subjects will be treated with 2 consecutive days of IV Depacon (1000 mg/day) followed by oral Depakote ER (1000 mg/day). Subject continues oral Depakote ER until end of cluster cycle or for a maximum of 6 weeks, which ever comes first.
1221906|NCT00203242|O1|Outcome|Depacon IV and Depakote|Subjects will be treated with 2 consecutive days of IV Depacon (1000 mg/day) followed by oral Depakote ER (1000 mg/day). Subject continues oral Depakote ER until end of cluster cycle or for a maximum of 6 weeks, which ever comes first.
1221907|NCT00203242|E1|Reported Event|Depacon IV and Depakote|Subjects will be treated with 2 consecutive days of IV Depacon (1000 mg/day) followed by oral Depakote ER (1000 mg/day). Subject continues oral Depakote ER until end of cluster cycle or for a maximum of 6 weeks, which ever comes first.
1221908|NCT00203229|B3|Baseline|Total|Total of all reporting groups
1221909|NCT00203229|B2|Baseline|Lamotrigine|The intervention type is 'drug' and this arm is the active drug created and supplied by the manufacturers of lamotrigine (Lamictal). This is an anti-seizure medication.
1221910|NCT00203229|B1|Baseline|Placebo|The intervention type is 'drug' and this arm is a placebo pill created and supplied by the manufacturers of lamotrigine (Lamictal) to be exact replicas of the actual drug being studied. The placebo arm is titrated in the exact same manor as the active drug arm.
1221911|NCT00203229|P2|Participant Flow|Lamotrigine|The intervention type is 'drug' and this arm is the active drug supplied by the manufacturers of lamotrigine (Lamictal) to be exact replicas of the actual drug being studied. This drug is an anti-seizure medication.
1221912|NCT00203229|P1|Participant Flow|Placebo|The intervention type is 'drug' and this arm is a placebo pill created and supplied by the manufacturers of lamotrigine (Lamictal) to be exact replicas of the actual drug being studied. The placebo arm is titrated in the exact same manor as the active drug arm.
1221913|NCT00203229|O2|Outcome|Lamotrigine|Dosing Schedule Morning Evening Daily Total Week 1-2 ---- 50mg 50mg Week 3-4 50mg 50mg 100mg Week 5 100mg 100mg 200mg Week 6 150mg 150mg 300mg Week 7 200mg 200mg 400mg Week 8 (if needed for pain) 200mg 300mg 500mg Week 9 (if needed for pain) 300mg 300mg 600mg Week 10 (if needed for pain) 300mg 400mg 700mg
1221914|NCT00203229|O1|Outcome|Placebo|Dosing Schedule Morning Evening Daily Total Week 1-2 ---- 50mg 50mg Week 3-4 50mg 50mg 100mg Week 5 100mg 100mg 200mg Week 6 150mg 150mg 300mg Week 7 200mg 200mg 400mg Week 8 (if needed for pain) 200mg 300mg 500mg Week 9 (if needed for pain) 300mg 300mg 600mg Week 10 (if needed for pain) 300mg 400mg 700mg
1221915|NCT00203229|E2|Reported Event|Lamotrigine|Subjects who received Lamotrigine
1221916|NCT00203229|E1|Reported Event|Placebo|Subjects who received placebo
1221949|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
1221917|NCT00203216|B1|Baseline|Levetiracetam/Transcranial Magnetic Stimulation|In this open label trial, all subjects will receive levetiracetam. Subjects may be titrated up to their maximum tolerated dose (MTD) or 3000 mg daily, whichever is lowest. Subjects who cannot tolerate a dose of at least 1000mg per day will be discontinued from the trial. Transmagnetic stimulation will be performed to measure cortical excitability at various intervals during the study.
1221918|NCT00203216|P1|Participant Flow|Levetiracetam/Transcranial Magnetic Stimulation|In this open label trial, all subjects will receive levetiracetam. Subjects may be titrated up to their maximum tolerated dose (MTD) or 3000 mg daily, whichever is lowest. Subjects who cannot tolerate a dose of at least 1000mg per day will be discontinued from the trial. Transmagnetic stimulation will be performed to measure cortical excitability at various intervals during the study.
1221957|NCT00203047|P2|Participant Flow|GA + Prednisone|Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
1241311|NCT00117338|O1|Outcome|Montelukast Intravenous (IV) 5.25 mg|
1221919|NCT00203216|O1|Outcome|Levetiracetam/Transcranial Magnetic Stimulation|In this open label trial, all subjects will receive levetiracetam. Subjects may be titrated up to their maximum tolerated dose (MTD) or 3000 mg daily, whichever is lowest. Subjects who cannot tolerate a dose of at least 1000mg per day will be discontinued from the trial. Transmagnetic stimulation will be performed to measure cortical excitability at various intervals during the study.
1221920|NCT00203216|E1|Reported Event|Levetiracetam/Transcranial Magnetic Stimulation|In this open label trial, all subjects will receive levetiracetam. Subjects may be titrated up to their maximum tolerated dose (MTD) or 3000 mg daily, whichever is lowest. Subjects who cannot tolerate a dose of at least 1000mg per day will be discontinued from the trial. Transmagnetic stimulation will be performed to measure cortical excitability at various intervals during the study.
1221921|NCT00203203|B3|Baseline|Total|Total of all reporting groups
1221922|NCT00203203|B2|Baseline|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
1221923|NCT00203203|B1|Baseline|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
1221924|NCT00203203|P2|Participant Flow|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
1221925|NCT00203203|P1|Participant Flow|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
1221926|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
1221927|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
1221928|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
1221929|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
1221930|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
1221931|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
1221932|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
1221933|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
1221934|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
1221935|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
1221936|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
1221937|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
1221938|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
1221939|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
1221940|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
1221941|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
1221942|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
1221943|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
1221944|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
1221945|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
1221946|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
1221947|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
1221948|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
1221950|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
1221951|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
1221952|NCT00203203|E2|Reported Event|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
1221953|NCT00203203|E1|Reported Event|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
1221954|NCT00203047|B3|Baseline|Total|Total of all reporting groups
1221955|NCT00203047|B2|Baseline|GA + Prednisone|Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
1221998|NCT00202722|O1|Outcome|Remifentanil|"Pain scores~Satisfaction"
1221958|NCT00203047|P1|Participant Flow|GA + Placebo|Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
1221959|NCT00203047|O2|Outcome|GA + Prednisone|Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
1221960|NCT00203047|O1|Outcome|GA + Placebo|Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
1221961|NCT00203047|O2|Outcome|GA + Prednisone|Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
1221962|NCT00203047|O1|Outcome|GA + Placebo|Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
1221963|NCT00203047|O2|Outcome|GA + Prednisone|Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
1221964|NCT00203047|O1|Outcome|GA + Placebo|Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
1221965|NCT00203047|O2|Outcome|GA + Prednisone|Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
1221966|NCT00203047|O1|Outcome|GA + Placebo|Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
1221967|NCT00203047|E2|Reported Event|GA + Prednisone|Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
1221968|NCT00203047|E1|Reported Event|GA + Placebo|Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
1221969|NCT00202878|B3|Baseline|Total|Total of all reporting groups
1221970|NCT00202878|B2|Baseline|Simvastatin|One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
1221971|NCT00202878|B1|Baseline|Ezetimibe/Simvastatin|One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
1221972|NCT00202878|P2|Participant Flow|Simvastatin|One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
1221973|NCT00202878|P1|Participant Flow|Ezetimibe/Simvastatin|One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
1221974|NCT00202878|O2|Outcome|Simvastatin|One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
1221975|NCT00202878|O1|Outcome|Ezetimibe/Simvastatin|One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
1221976|NCT00202878|O2|Outcome|Simvastatin|One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
1221977|NCT00202878|O1|Outcome|Ezetimibe/Simvastatin|One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
1221978|NCT00202878|O2|Outcome|Simvastatin|One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
1221979|NCT00202878|O1|Outcome|Ezetimibe/Simvastatin|One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
1221980|NCT00202878|O2|Outcome|Simvastatin|One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
1221981|NCT00202878|O1|Outcome|Ezetimibe/Simvastatin|One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
1221982|NCT00202878|E2|Reported Event|Simvastatin|One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
1221983|NCT00202878|E1|Reported Event|Ezetimide/Simvastatin|One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
1221984|NCT00202839|B3|Baseline|Total|Total of all reporting groups
1221985|NCT00202839|B2|Baseline|48-Week Treatment|Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization)
1221986|NCT00202839|B1|Baseline|24-Week Treatment|Genotype 1 hepatitis C virus [HCV] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization)
1221987|NCT00202839|P2|Participant Flow|48-Week Treatment|Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization)
1221988|NCT00202839|P1|Participant Flow|24-Week Treatment|Genotype 1 hepatitis C virus [HCV] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization)
1221989|NCT00202839|O2|Outcome|48-Week Treatment|Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization)
1221990|NCT00202839|O1|Outcome|24-Week Treatment|Genotype 1 hepatitis C virus [HCV] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization)
1227895|NCT00168454|B7|Baseline|Total|Total of all reporting groups
1221991|NCT00202839|O2|Outcome|48-Week Treatment|Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization)
1221992|NCT00202839|O1|Outcome|24-Week Treatment|Genotype 1 hepatitis C virus [HCV] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization)
1221993|NCT00202839|E2|Reported Event|48-Week Treatment|
1221994|NCT00202839|E1|Reported Event|24-Week Treatment|
1221995|NCT00202722|B1|Baseline|Women in Labour Given Remifentanil Analgesia|Administration of remifentanil analgesia startet with cervical dilatation > 4 cm
1221996|NCT00202722|P1|Participant Flow|Effect and Side Effects of Remifentanil|Analgesic efficacy and side offects of remifentanil during labour and delivery
1221997|NCT00202722|O1|Outcome|Satisfaction With Remifentanil Analgesia|Patient satisfaction with remifentanil pain relief by use of questionnaire (within 24-hours after delivery)
1221999|NCT00202722|E1|Reported Event|Maternal Oxygen Desaturation|Oxygen saturation lower than 92% during labour and delivery
1222000|NCT00202449|B4|Baseline|Total|Total of all reporting groups
1222001|NCT00202449|B3|Baseline|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
1222002|NCT00202449|B2|Baseline|Paroxetine|Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.
1222003|NCT00202449|B1|Baseline|Prazosin|Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.
1222004|NCT00202449|P3|Participant Flow|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
1222005|NCT00202449|P2|Participant Flow|Paroxetine|Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.
1222006|NCT00202449|P1|Participant Flow|Prazosin|Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.
1222007|NCT00202449|O3|Outcome|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
1222008|NCT00202449|O2|Outcome|Paroxetine|Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.
1222009|NCT00202449|O1|Outcome|Prazosin|Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.
1222010|NCT00202449|O3|Outcome|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
1222011|NCT00202449|O2|Outcome|Paroxetine|Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.
1222012|NCT00202449|O1|Outcome|Prazosin|Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.
1222013|NCT00202449|O3|Outcome|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
1222014|NCT00202449|O2|Outcome|Paroxetine|Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.
1222015|NCT00202449|O1|Outcome|Prazosin|Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.
1222016|NCT00202449|E3|Reported Event|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
1222017|NCT00202449|E2|Reported Event|Paroxetine|Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.
1222018|NCT00202449|E1|Reported Event|Prazosin|Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.
1222019|NCT00201877|B1|Baseline|Velcade and Rituximab|"Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration.~Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14"
1222020|NCT00201877|P1|Participant Flow|Velcade and Rituximab|"Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration.~Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14"
1222021|NCT00201877|O1|Outcome|Velcade and Rituximab|"Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration.~Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14"
1222022|NCT00201877|O1|Outcome|Velcade and Rituximab|"Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration.~Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14"
1222023|NCT00201877|O1|Outcome|Velcade and Rituximab|"Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration.~Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14"
1222024|NCT00201877|E1|Reported Event|Velcade and Rituximab|"Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration.~Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14"
1222025|NCT00201864|B1|Baseline|Exemestane and Fulvestrant|"Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection~Exemestane: 25 mg orally per day~Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days."
1222026|NCT00201864|P1|Participant Flow|Exemestane and Fulvestrant|"Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection~Exemestane: 25 mg orally per day~Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days."
1222027|NCT00201864|O2|Outcome|IGFBP-3|IGFBP-3-insulin-like growth factor-binding
1222028|NCT00201864|O1|Outcome|IGF-1|IGF-1-insulin-like growth factor
1222029|NCT00201864|O1|Outcome|Exemestane and Fulvestrant|"Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection~Exemestane: 25 mg orally per day~Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days."
1222030|NCT00201864|O1|Outcome|Exemestane and Fulvestrant|"Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection~Exemestane: 25 mg orally per day~Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days."
1222031|NCT00201864|O1|Outcome|Exemestane and Fulvestrant|"Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection~Exemestane: 25 mg orally per day~Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days."
1222032|NCT00201864|E1|Reported Event|Single-arm Study|"Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection~Exemestane: 25 mg orally per day~Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days."
1222033|NCT00201851|B4|Baseline|Total|Total of all reporting groups
1222081|NCT00201734|P1|Participant Flow|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
1222207|NCT00201006|O1|Outcome|Face-to-face Counseling|26 biweekly face-to-face group counseling sessions
1222034|NCT00201851|B3|Baseline|C- Immediate Surgery - Nonrandomized|"Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
1222035|NCT00201851|B2|Baseline|B - Immediate Surgery|"Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
1222036|NCT00201851|B1|Baseline|A - Scheduled Surgery|"Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
1222037|NCT00201851|P3|Participant Flow|C- Immediate Surgery - Nonrandomized|"Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
1222038|NCT00201851|P2|Participant Flow|B - Immediate Surgery|"Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
1222039|NCT00201851|P1|Participant Flow|A - Scheduled Surgery|"Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
1222040|NCT00201851|O3|Outcome|C- Immediate Surgery - Nonrandomized|"Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
1222041|NCT00201851|O2|Outcome|B - Immediate Surgery|"Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
1222042|NCT00201851|O1|Outcome|A - Scheduled Surgery|"Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
1222043|NCT00201851|E3|Reported Event|C- Immediate Surgery - Nonrandomized|"Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
1222044|NCT00201851|E2|Reported Event|B - Immediate Surgery|"Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
1222045|NCT00201851|E1|Reported Event|A - Scheduled Surgery|"Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
1222046|NCT00201838|B3|Baseline|Total|Total of all reporting groups
1222047|NCT00201838|B2|Baseline|Control Arm|Patients received Gemcitabine alone
1222048|NCT00201838|B1|Baseline|Interventional Arm|Patients received Etanercept with gemcitabine
1222049|NCT00201838|P2|Participant Flow|Control Group|Patients received gemcitabine alone
1222076|NCT00201773|E1|Reported Event|Exemestane Alone|"Patients will receive exemestane 25 mg orally per day for 8 weeks. Starting in the 9th week, patients will receive celecoxib 400 mg orally twice per day for 8 weeks in addition to exemestane.~Exemestane: 25 mg orally once per day for 16 weeks.~Celecoxib: given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day should be instructed to take the drug with food."
1222050|NCT00201838|P1|Participant Flow|Experimental Group|"combination of gemcitabine and etanercept~Gemcitabine: The starting dose will be 1000mg/m2 IV, weekly x 7 with a one week rest followed by weekly x 3 with one week rest for the remainder of treatment.~Etanercept: Etanercept will be self administered subcutaneously by patients with injections 11 prepared by the investigational pharmacy, beginning 7 days prior to the first dose of gemcitabine and continued twice weekly for the duration of the study."
1222082|NCT00201734|O2|Outcome|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
1222208|NCT00201006|E3|Reported Event|Mail|received by mail 26 biweekly newsletters with weight management information
1222051|NCT00201838|O2|Outcome|Non Responders|"Gemcitabine: The starting dose will be 1000mg/m2 IV, weekly x 7 with a one week rest followed by weekly x 3 with one week rest for the remainder of treatment.~Etanercept: Etanercept will be self administered subcutaneously by patients with injections 11 prepared by the investigational pharmacy, beginning 7 days prior to the first dose of gemcitabine and continued twice weekly for the duration of the study."
1222052|NCT00201838|O1|Outcome|Responders|"combination of gemcitabine and etanercept~Gemcitabine: The starting dose will be 1000mg/m2 IV, weekly x 7 with a one week rest followed by weekly x 3 with one week rest for the remainder of treatment.~Etanercept: Etanercept will be self administered subcutaneously by patients with injections 11 prepared by the investigational pharmacy, beginning 7 days prior to the first dose of gemcitabine and continued twice weekly for the duration of the study."
1222053|NCT00201838|O2|Outcome|Control Group|gemcitabine alone
1222054|NCT00201838|O1|Outcome|Experimental Group|"combination of gemcitabine and etanercept~Gemcitabine: The starting dose will be 1000mg/m2 IV, weekly x 7 with a one week rest followed by weekly x 3 with one week rest for the remainder of treatment.~Etanercept: Etanercept will be self administered subcutaneously by patients with injections 11 prepared by the investigational pharmacy, beginning 7 days prior to the first dose of gemcitabine and continued twice weekly for the duration of the study."
1222055|NCT00201838|O2|Outcome|Control Group|Gemcitabine alone
1222056|NCT00201838|O1|Outcome|Experimental Group|Etanercept with gemcitabine
1222057|NCT00201838|O2|Outcome|Control Group|Patients received gemcitabine alone
1222058|NCT00201838|O1|Outcome|Experimental Group|"combination of gemcitabine and etanercept~Gemcitabine: The starting dose will be 1000mg/m2 IV, weekly x 7 with a one week rest followed by weekly x 3 with one week rest for the remainder of treatment.~Etanercept: Etanercept will be self administered subcutaneously by patients with injections 11 prepared by the investigational pharmacy, beginning 7 days prior to the first dose of gemcitabine and continued twice weekly for the duration of the study."
1222059|NCT00201838|O2|Outcome|Control Group|Patients received gemcitabine alone
1222060|NCT00201838|O1|Outcome|Experimental Group|Patients received etanercept 25mg subcutaneously twice-weekly with gemcitabine
1222061|NCT00201838|E2|Reported Event|Control Group|Patients in the control cohort received gemcitabine alone.
1222062|NCT00201838|E1|Reported Event|Experimental Group|Patients in the experimental group received etancercept 25 mg subcutaneously twice-weekly with gemcitabine.
1222063|NCT00201825|B1|Baseline|Docetaxel and Capecitabine|"Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.~Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks."
1222064|NCT00201825|P1|Participant Flow|Docetaxel and Capecitabine|"Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.~Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks."
1222065|NCT00201825|O1|Outcome|Docetaxel and Capecitabine|"Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.~Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks."
1222066|NCT00201825|O1|Outcome|Docetaxel and Capecitabine|"Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.~Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks."
1222067|NCT00201825|O1|Outcome|Docetaxel and Capecitabine|"Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.~Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks."
1222068|NCT00201825|O1|Outcome|Docetaxel and Capecitabine|"Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.~Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks."
1222069|NCT00201825|E1|Reported Event|Docetaxel and Capecitabine|"Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.~Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks."
1222070|NCT00201773|B1|Baseline|Exemestane & Celecoxib|"Patients will received exemestane 25 mg orally per day for 8 weeks. Starting in the 9th week, patients will receive celecoxib 400 mg orally twice per day for 8 weeks in addition to exemestane.~Exemestane: 25 mg orally once per day for 16 weeks.~Celecoxib: given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day and instructed to take the drug with food.~Correlative studies"
1222071|NCT00201773|P1|Participant Flow|Exemestane & Celecoxib|"Patients will receive exemestane 25 mg orally per day for 8 weeks. Starting in the 9th week, patients will receive celecoxib 400 mg orally twice per day for 8 weeks in addition to exemestane.~Exemestane: 25 mg orally once per day for 16 weeks.~Celecoxib: given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day should be instructed to take the drug with food.~Correlative studies"
1222072|NCT00201773|O1|Outcome|Exemestane & Celecoxib|"Patients will receive exemestane 25 mg orally per day for 8 weeks. Starting in the 9th week, patients will receive celecoxib 400 mg orally twice per day for 8 weeks in addition to exemestane.~Exemestane: 25 mg orally once per day for 16 weeks.~Celecoxib: given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day should be instructed to take the drug with food.~Correlative studies"
1222073|NCT00201773|O2|Outcome|Exemestane|Exemestane (8 weeks) vs. Baseline
1222074|NCT00201773|O1|Outcome|Exemestane + Celecoxib|Exemestane + celecoxib (16 weeks) vs. Baseline
1222075|NCT00201773|E2|Reported Event|Exemestane + Celecoxib|"Patients will receive exemestane 25 mg orally per day for 8 weeks. Starting in the 9th week, patients will receive celecoxib 400 mg orally twice per day for 8 weeks in addition to exemestane.~Exemestane: 25 mg orally once per day for 16 weeks.~Celecoxib: given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day should be instructed to take the drug with food."
1222077|NCT00201734|B3|Baseline|Total|Total of all reporting groups
1222078|NCT00201734|B2|Baseline|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
1222079|NCT00201734|B1|Baseline|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
1222080|NCT00201734|P2|Participant Flow|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
1222083|NCT00201734|O1|Outcome|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
1222084|NCT00201734|O2|Outcome|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
1222085|NCT00201734|O1|Outcome|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
1222086|NCT00201734|O2|Outcome|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
1222087|NCT00201734|O1|Outcome|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
1222088|NCT00201734|O2|Outcome|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
1222089|NCT00201734|O1|Outcome|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
1222090|NCT00201734|O2|Outcome|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
1222091|NCT00201734|O1|Outcome|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
1222092|NCT00201734|O1|Outcome|Phase I Patients|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
1222093|NCT00201734|E2|Reported Event|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
1222094|NCT00201734|E1|Reported Event|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
1222095|NCT00201643|B3|Baseline|Total|Total of all reporting groups
1222096|NCT00201643|B2|Baseline|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
1222097|NCT00201643|B1|Baseline|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
1222098|NCT00201643|P2|Participant Flow|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
1222099|NCT00201643|P1|Participant Flow|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
1222100|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
1222101|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
1222102|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
1222103|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
1222104|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
1222105|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
1222106|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
1222144|NCT00201240|B1|Baseline|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
1222209|NCT00201006|E2|Reported Event|Telephone|received 26 biweekly individual telephone counseling sessions
1222107|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
1222108|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
1222109|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
1222110|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
1222111|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
1222112|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
1222113|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
1222114|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
1222115|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
1222116|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
1222117|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
1222118|NCT00201643|E2|Reported Event|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
1222119|NCT00201643|E1|Reported Event|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
1222120|NCT00201448|B3|Baseline|Total|Total of all reporting groups
1222121|NCT00201448|B2|Baseline|Towne CMV Vaccine|
1222122|NCT00201448|B1|Baseline|Placebo (Hepatitis A)|
1222123|NCT00201448|P2|Participant Flow|Towne CMV Vaccine|
1222124|NCT00201448|P1|Participant Flow|Placebo (Hepatitis A)|
1222125|NCT00201448|O2|Outcome|Towne Vaccine|"Towne vaccine given at 3000 pfu/subject~Towne CMV Vaccine: Single dose given subcutaneously"
1222126|NCT00201448|O1|Outcome|Placebo (Hepatitis A)|"Placebo group~Hepatitis A Vaccine: Single dose give IM"
1222127|NCT00201448|O2|Outcome|Towne CMV Vaccine|
1222128|NCT00201448|O1|Outcome|(Placebo) Hepatitis a|This is the comparator group.
1222129|NCT00201448|E2|Reported Event|Towne CMV Vaccine|
1222130|NCT00201448|E1|Reported Event|Placebo (Hepatitis A)|
1222131|NCT00201409|B3|Baseline|Total|Total of all reporting groups
1222132|NCT00201409|B2|Baseline|Placebo Group|Participants will be randomized to receive placebo.
1222133|NCT00201409|B1|Baseline|GM-CSF Group|Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
1222134|NCT00201409|P2|Participant Flow|Placebo Group|Participants will be randomized to receive placebo.
1222135|NCT00201409|P1|Participant Flow|GM-CSF Group|Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
1222136|NCT00201409|O2|Outcome|Placebo Group|Participants will be randomized to receive placebo.
1222137|NCT00201409|O1|Outcome|GM-CSF Group|Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
1222138|NCT00201409|O2|Outcome|Placebo Group|Participants will be randomized to receive placebo.
1222199|NCT00201006|B3|Baseline|Mail Contact|26 biweekly newsletters with weight management advice
1222139|NCT00201409|O1|Outcome|GM-CSF Group|Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
1222140|NCT00201409|O2|Outcome|Placebo Group|Participants will be randomized to receive placebo.
1222141|NCT00201409|O1|Outcome|GM-CSF Group|Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
1222142|NCT00201409|E2|Reported Event|Placebo Group|Participants will be randomized to receive placebo.
1222143|NCT00201409|E1|Reported Event|GM-CSF Group|Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
1222145|NCT00201240|P1|Participant Flow|T Cell Depletion|T cell depletion using Miltenyi device for patients with acute myeloid leukemia (AML) in first or second complete remission
1222146|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
1222147|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with acute myeloid leukemia (AML) in first or second complete remission
1222148|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
1222149|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
1222150|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
1222151|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
1222152|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
1222153|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
1222154|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
1222155|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
1222156|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
1222157|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
1222158|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
1222159|NCT00201240|E1|Reported Event|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
1222160|NCT00201201|B3|Baseline|Total|Total of all reporting groups
1222161|NCT00201201|B2|Baseline|Control|"Control:~Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
1222162|NCT00201201|B1|Baseline|Education Intervention|"PEP education intervention~Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program."
1222163|NCT00201201|P2|Participant Flow|Control|"Control:~Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
1222164|NCT00201201|P1|Participant Flow|Education Intervention|"PEP education intervention~Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program generated by the PEP-NG software and reinforced by the APRN."
1222165|NCT00201201|O2|Outcome|Control|"Control:~Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
1222166|NCT00201201|O1|Outcome|Education Intervention|"PEP education intervention~Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program generated by the PEP-NG software and reinforced by the APRN."
1222167|NCT00201201|O2|Outcome|Control|"Control:~Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
1222168|NCT00201201|O1|Outcome|Education Intervention|"PEP education intervention~Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program generated by the PEP-NG software and reinforced by the APRN."
1222197|NCT00201123|E1|Reported Event|DOTS Control Group|"DOTS Control Group~IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy."
1222169|NCT00201201|O2|Outcome|Control|"Control:~Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
1222204|NCT00201006|P1|Participant Flow|Face-to-face Counseling|26 biweekly face-to-face group counseling sessions
1222205|NCT00201006|O3|Outcome|Mail Contact|26 biweekly newsletters with weight management advice
1222206|NCT00201006|O2|Outcome|Telephone Counseling|26 biweekly telephone counseling sessions
1222170|NCT00201201|O1|Outcome|Education Intervention|"PEP education intervention~Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program generated by the PEP-NG software and reinforced by the APRN."
1222171|NCT00201201|O2|Outcome|Control|"Control:~Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
1222172|NCT00201201|O1|Outcome|Education Intervention|"PEP education intervention~Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program generated by the PEP-NG software and reinforced by the APRN."
1222173|NCT00201201|O2|Outcome|Control|"Control:~Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
1222174|NCT00201201|O1|Outcome|Education Intervention|"PEP education intervention~Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program generated by the PEP-NG software and reinforced by the APRN."
1222175|NCT00201201|O2|Outcome|Control|"Control:~Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
1222176|NCT00201201|O1|Outcome|Education Intervention|"PEP education intervention~Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program generated by the PEP-NG software and reinforced by the APRN."
1222177|NCT00201201|E2|Reported Event|Control|Control group without education intervention.
1222178|NCT00201201|E1|Reported Event|Education|"PEP education intervention~Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension will be randomized to usual care and intervention groups. Both groups will enter medication taking behaviors on the PEP-NG and answer questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The intervention group will receive a tailored education program."
1222179|NCT00201123|B4|Baseline|Total|Total of all reporting groups
1222180|NCT00201123|B3|Baseline|Subcutaneous Interferon Gamma for TB|"Subcutaneous Interferon-Gamma~Subcutaneous Interferon-Gamma: Participants will receive subcutaneous interferon-gamma."
1222181|NCT00201123|B2|Baseline|Aerosol Interferon Gamma for TB|"Aerosol Interferon-Gamma~Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma."
1222182|NCT00201123|B1|Baseline|DOTS Control Group|"IRPE Anti-Tuberculous Therapy~IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy."
1222183|NCT00201123|P3|Participant Flow|Subcutaneous Interferon Gamma for TB|"Subcutaneous Interferon-Gamma~Subcutaneous Interferon-Gamma: Partcipants will receive subcutaneous interferon-gamma."
1222184|NCT00201123|P2|Participant Flow|Aerosol Interferon Gamma for TB|"Aerosol Interferon-Gamma~Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma."
1222185|NCT00201123|P1|Participant Flow|DOTS Control Group|"DOTS Control Group~IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy."
1222186|NCT00201123|O3|Outcome|Subcutaneous rlFN-y|
1222187|NCT00201123|O2|Outcome|Nebulized rlFN-y|
1222188|NCT00201123|O1|Outcome|DOTS|
1222189|NCT00201123|O3|Outcome|Subcutaneous Interferon Gamma for TB|"Subcutaneous Interferon-Gamma~Subcutaneous Interferon-Gamma: Participants will receive subcutaneous interferon-gamma."
1222190|NCT00201123|O2|Outcome|Aerosol Interferon Gamma for TB|"Aerosol Interferon-Gamma~Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma."
1222191|NCT00201123|O1|Outcome|DOTS Control Group|"IRPE Anti-Tuberculous Therapy~IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy."
1222192|NCT00201123|O3|Outcome|Subcutaneous Interferon Gamma for TB|"Subcutaneous Interferon-Gamma~Subcutaneous Interferon-Gamma: Partcipants will receive subcutaneous interferon-gamma."
1222193|NCT00201123|O2|Outcome|Aerosol Interferon Gamma for TB|"Aerosol Interferon-Gamma~Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma."
1222194|NCT00201123|O1|Outcome|DOTS Control Group|"IRPE Anti-Tuberculous Therapy~IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy."
1222195|NCT00201123|E3|Reported Event|Subcutaneous Interferon Gamma for TB|"Subcutaneous Interferon-Gamma~Subcutaneous Interferon-Gamma: Partcipants will receive subcutaneous interferon-gamma."
1222196|NCT00201123|E2|Reported Event|Aerosol Interferon Gamma for TB|"Aerosol Interferon-Gamma~Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma."
1222200|NCT00201006|B2|Baseline|Telephone Counseling|26 biweekly telephone counseling sessions
1222201|NCT00201006|B1|Baseline|Face-to-face Counseling|26 biweekly face-to-face group counseling sessions
1222202|NCT00201006|P3|Participant Flow|Mail Contact|26 biweekly newsletters with weight management advice
1222203|NCT00201006|P2|Participant Flow|Telephone Counseling|26 biweekly telephone counseling sessions
1222210|NCT00201006|E1|Reported Event|Face-to-face|received 26 biweekly office-based, face-to-face group counseling sessions
1222211|NCT00200967|B3|Baseline|Total|Total of all reporting groups
1222212|NCT00200967|B2|Baseline|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
1222213|NCT00200967|B1|Baseline|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
1222214|NCT00200967|P2|Participant Flow|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
1222215|NCT00200967|P1|Participant Flow|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
1222216|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
1222217|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
1222218|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
1222219|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
1222220|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
1222221|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
1222222|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
1222223|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
1222224|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
1222225|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
1222226|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
1222227|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
1222228|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
1222229|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
1222322|NCT00199914|P1|Participant Flow|Shortwave Diathermy|continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
1222230|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
1222231|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
1222232|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
1222273|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
1222233|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
1222234|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
1222235|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
1222236|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
1222237|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
1222238|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
1222239|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
1222240|NCT00200967|E2|Reported Event|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
1222241|NCT00200967|E1|Reported Event|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
1222242|NCT00200785|B3|Baseline|Total|Total of all reporting groups
1222243|NCT00200785|B2|Baseline|Garlic Powder: No Allicin|garlic powder in boiling water
1222244|NCT00200785|B1|Baseline|Garlic Powder: High Allicin|garlic powder in ambient water
1222245|NCT00200785|P2|Participant Flow|Garlic Powder: No Allicin|garlic powder in boiling water
1222246|NCT00200785|P1|Participant Flow|Garlic Powder: High Allicin|garlic powder in ambient water
1222247|NCT00200785|O2|Outcome|Garlic Powder: No Allicin|garlic powder in boiling water
1222248|NCT00200785|O1|Outcome|Garlic Powder: High Allicin|garlic powder in ambient water
1222249|NCT00200785|O2|Outcome|Garlic Powder: No Allicin|garlic powder in boiling water
1222250|NCT00200785|O1|Outcome|Garlic Powder: High Allicin|garlic powder in ambient water
1222251|NCT00200785|E2|Reported Event|Garlic Powder: No Allicin|garlic powder in boiling water
1222252|NCT00200785|E1|Reported Event|Garlic Powder: High Allicin|garlic powder in ambient water
1222253|NCT00200356|B3|Baseline|Total|Total of all reporting groups
1222254|NCT00200356|B2|Baseline|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
1222255|NCT00200356|B1|Baseline|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
1222256|NCT00200356|P2|Participant Flow|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
1222257|NCT00200356|P1|Participant Flow|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
1222258|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
1222259|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
1222260|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
1222261|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
1222262|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
1222263|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
1222264|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
1222265|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
1222266|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
1230700|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
1222267|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
1222268|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
1222269|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
1222270|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
1222271|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
1222272|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
1222274|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
1222275|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
1222276|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
1222277|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
1222278|NCT00200356|E2|Reported Event|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
1222279|NCT00200356|E1|Reported Event|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
1222280|NCT00200343|B4|Baseline|Total|Total of all reporting groups
1222281|NCT00200343|B3|Baseline|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
1222282|NCT00200343|B2|Baseline|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
1222283|NCT00200343|B1|Baseline|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
1222284|NCT00200343|P3|Participant Flow|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
1222285|NCT00200343|P2|Participant Flow|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
1222286|NCT00200343|P1|Participant Flow|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
1222287|NCT00200343|O3|Outcome|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
1222288|NCT00200343|O2|Outcome|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
1222289|NCT00200343|O1|Outcome|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
1222290|NCT00200343|O3|Outcome|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
1222291|NCT00200343|O2|Outcome|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
1222292|NCT00200343|O1|Outcome|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
1222293|NCT00200343|O3|Outcome|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
1222294|NCT00200343|O2|Outcome|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
1222295|NCT00200343|O1|Outcome|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
1222296|NCT00200343|O3|Outcome|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
1222297|NCT00200343|O2|Outcome|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
1222298|NCT00200343|O1|Outcome|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
1222299|NCT00200343|O3|Outcome|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
1222300|NCT00200343|O2|Outcome|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
1222301|NCT00200343|O1|Outcome|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
1222302|NCT00200343|O3|Outcome|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
1222303|NCT00200343|O2|Outcome|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
1222304|NCT00200343|O1|Outcome|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
1222305|NCT00200343|E3|Reported Event|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
1222306|NCT00200343|E2|Reported Event|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
1222307|NCT00200343|E1|Reported Event|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
1222308|NCT00200057|B1|Baseline|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
1222309|NCT00200057|P1|Participant Flow|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
1222310|NCT00200057|O1|Outcome|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
1222311|NCT00200057|O1|Outcome|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
1222312|NCT00200057|O1|Outcome|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
1222313|NCT00200057|O1|Outcome|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
1222314|NCT00200057|O1|Outcome|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
1222315|NCT00200057|O1|Outcome|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
1222316|NCT00200057|O1|Outcome|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
1222317|NCT00200057|E1|Reported Event|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
1222318|NCT00199914|B3|Baseline|Total|Total of all reporting groups
1222319|NCT00199914|B2|Baseline|Control|continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
1222320|NCT00199914|B1|Baseline|Shortwave Diathermy|continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
1222321|NCT00199914|P2|Participant Flow|Control|continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
1223068|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1222323|NCT00199914|O2|Outcome|Control|continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
1222324|NCT00199914|O1|Outcome|Shortwave Diathermy|continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
1222325|NCT00199914|E2|Reported Event|Control|continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
1222326|NCT00199914|E1|Reported Event|Shortwave Diathermy|continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
1222327|NCT00199381|B1|Baseline|Single Arm|Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
1222328|NCT00199381|P1|Participant Flow|Single Arm|Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
1222329|NCT00199381|O1|Outcome|Single Arm|Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
1222330|NCT00199381|E1|Reported Event|Single Arm|Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
1222332|NCT00198822|B3|Baseline|3 Beta-Carotene Group|Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
1222333|NCT00198822|B2|Baseline|2 Vitamin A Supplement|Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
1222334|NCT00198822|B1|Baseline|1 Placebo Control|Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
1222335|NCT00198822|P3|Participant Flow|3 Beta-Carotene Group|Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
1222336|NCT00198822|P2|Participant Flow|2 Vitamin A Supplement|Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
1222337|NCT00198822|P1|Participant Flow|1 Placebo Control|Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
1222338|NCT00198822|O3|Outcome|3 Beta-Carotene Group|Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
1222339|NCT00198822|O2|Outcome|2 Vitamin A Supplement|Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
1222340|NCT00198822|O1|Outcome|1 Placebo Control|Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
1222341|NCT00198822|O3|Outcome|3 Beta-Carotene Group|Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
1222342|NCT00198822|O2|Outcome|2 Vitamin A Supplement|Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
1222343|NCT00198822|O1|Outcome|1 Placebo Control|Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
1222344|NCT00198822|O3|Outcome|3 Beta-Carotene Group|Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
1222345|NCT00198822|O2|Outcome|2 Vitamin A Supplement|Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
1222346|NCT00198822|O1|Outcome|1 Placebo Control|Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
1222347|NCT00198822|O3|Outcome|3 Beta-Carotene Group|Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
1222348|NCT00198822|O2|Outcome|2 Vitamin A Supplement|Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
1222349|NCT00198822|O1|Outcome|1 Placebo Control|Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
1222350|NCT00198822|E3|Reported Event|3 Beta-Carotene Group|Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
1222351|NCT00198822|E2|Reported Event|2 Vitamin A Supplement|Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
1222352|NCT00198822|E1|Reported Event|1 Placebo Control|Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
1222353|NCT00197119|B3|Baseline|Total|Total of all reporting groups
1222354|NCT00197119|B2|Baseline|Group Twinrix Adult|Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
1222355|NCT00197119|B1|Baseline|Group Twinrix Junior|Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.
1222356|NCT00197119|P2|Participant Flow|Group Twinrix Adult|Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
1222357|NCT00197119|P1|Participant Flow|Group Twinrix Junior|Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.
1222358|NCT00197119|O2|Outcome|Group Twinrix Adult|Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
1222359|NCT00197119|O1|Outcome|Group Twinrix Junior|Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.
1222360|NCT00197119|O2|Outcome|Group Twinrix Adult|Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
1222361|NCT00197119|O1|Outcome|Group Twinrix Junior|Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.
1222362|NCT00197119|O2|Outcome|Group Twinrix Adult|Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
1222363|NCT00197119|O1|Outcome|Group Twinrix Junior|Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.
1222364|NCT00197119|E2|Reported Event|Group Twinrix Adult|Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
1222365|NCT00197119|E1|Reported Event|Group Twinrix Junior|Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.
1222366|NCT00198133|B3|Baseline|Total|Total of all reporting groups
1222367|NCT00198133|B2|Baseline|Thymic Carcinoma|Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
1222368|NCT00198133|B1|Baseline|Thymoma|Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
1222369|NCT00198133|P2|Participant Flow|Thymic Carcinoma|Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
1222370|NCT00198133|P1|Participant Flow|Thymoma|Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
1222371|NCT00198133|O2|Outcome|Thymic Carcinoma|Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
1222372|NCT00198133|O1|Outcome|Thymoma|Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
1222373|NCT00198133|O2|Outcome|Thymic Carcinoma|Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
1222374|NCT00198133|O1|Outcome|Thymoma|Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
1222375|NCT00198133|O2|Outcome|Thymic Carcinoma|Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
1222376|NCT00198133|O1|Outcome|Thymoma|Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
1222377|NCT00198133|E2|Reported Event|Thymic Carcinoma|Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
1222378|NCT00198133|E1|Reported Event|Thymoma|Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
1222379|NCT00198081|B3|Baseline|Total|Total of all reporting groups
1222380|NCT00198081|B2|Baseline|Medical Candidate|"COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP~COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP: 400 mg BID for 6 months prior to follow-up EUS or ERCP"
1222381|NCT00198081|B1|Baseline|Surgical Candidate|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
1222382|NCT00198081|P2|Participant Flow|Medical Candidate|"COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP~COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP: 400 mg BID for 6 months prior to follow-up EUS or ERCP"
1222383|NCT00198081|P1|Participant Flow|Surgical Candidate|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
1222384|NCT00198081|O5|Outcome|Surgical Candidate 6 Months|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
1222385|NCT00198081|O4|Outcome|Surgical Candidate 4 Weeks|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
1222386|NCT00198081|O3|Outcome|Surgical Candidate One Week|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
1222387|NCT00198081|O2|Outcome|Surgery Candidate Surgery|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
1222388|NCT00198081|O1|Outcome|Surgical Candidate Baseline|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
1222389|NCT00198081|O5|Outcome|Surgical Candidate 6 Months|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
1222390|NCT00198081|O4|Outcome|Surgical Candidate 4 Weeks|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
1222391|NCT00198081|O3|Outcome|Surgical Candidate One Week|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
1222392|NCT00198081|O2|Outcome|Surgery Candidate Surgery|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
1222393|NCT00198081|O1|Outcome|Surgical Candidate Baseline|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
1222394|NCT00198081|O5|Outcome|Surgical Candidate 6 Months|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
1222395|NCT00198081|O4|Outcome|Surgical Candidate 4 Weeks|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
1222396|NCT00198081|O3|Outcome|Surgical Candidate One Week|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
1222397|NCT00198081|O2|Outcome|Surgery Candidate Surgery|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
1222398|NCT00198081|O1|Outcome|Surgical Candidate Baseline|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
1222399|NCT00198081|O2|Outcome|Medical Candidate|"COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP~COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP: 400 mg BID for 6 months prior to follow-up EUS or ERCP"
1222400|NCT00198081|O1|Outcome|Surgical Candidate|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
1222401|NCT00198081|O5|Outcome|Surgical Candidate 6 Months|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
1222402|NCT00198081|O4|Outcome|Surgical Candidate 4 Weeks|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
1222403|NCT00198081|O3|Outcome|Surgical Candidate One Week|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
1222404|NCT00198081|O2|Outcome|Surgery Candidate Surgery|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
1222405|NCT00198081|O1|Outcome|Surgical Candidate Baseline|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
1222406|NCT00198081|E2|Reported Event|Medical Candidate|"COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP~COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP: 400 mg BID for 6 months prior to follow-up EUS or ERCP"
1222407|NCT00198081|E1|Reported Event|Surgical Candidate|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
1223069|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1222408|NCT00198042|B1|Baseline|Patients|Eighteen patients (including 12 men), mean age 35.5 6 8.7 years, who underwent ACL reconstruction.
1222409|NCT00198042|P1|Participant Flow|Patients|Eighteen patients (including 12 men), mean age 35.5 6 8.7 years, who underwent ACL reconstruction.
1222410|NCT00198042|O1|Outcome|All Patients|Tunnel expansion after ACL-R occurs early and primarily at the tunnel apertures. Expansion may not affect clinical outcome. Younger age, male sex, and delay from injury to ACL-R may be potential risks for enlargement.
1222411|NCT00198042|E1|Reported Event|Patients|Eighteen patients (including 12 men), mean age 35.5 6 8.7 years, who underwent ACL reconstruction.
1222412|NCT00198029|B1|Baseline|Open Label Group|Thirty-two patients were injected over ten months with Synvisc and followed for 6 months post injections.
1222413|NCT00198029|P1|Participant Flow|Synvisc Group|Thirty-two patients were injected once weekly for three weeks with Hylan G-F 20 and followed for 6 months post injections.
1222531|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
1222414|NCT00198029|O1|Outcome|Synvisc Group|Thirty-two patients were injected once weekly for three weeks with Hylan G-F 20 and followed for 6 months post injections.
1222415|NCT00198029|O1|Outcome|Synvisc Group|Thirty-two patients were injected once weekly for three weeks with Hylan G-F 20 and followed for 6 months post injections.
1222416|NCT00198029|E1|Reported Event|Open Label Group|Thirty-two patients were injected over ten months with Synvisc and followed for 6 months post injections.
1222417|NCT00197106|B3|Baseline|Total|Total of all reporting groups
1222418|NCT00197106|B2|Baseline|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
1222419|NCT00197106|B1|Baseline|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
1222420|NCT00197106|P3|Participant Flow|FP 200 mcg|FP 200 mcg (delivered as two 100 mcg puffs) BID via DISKUS inhaler
1222421|NCT00197106|P2|Participant Flow|Salmeterol/FP 50/100 mcg Plus Placebo|One puff Salmeterol/FP 50/100 mcg plus one puff placebo (matching one puff of FP in the 200 mcg group) BID via DISKUS inhaler
1222422|NCT00197106|P1|Participant Flow|Fluticasone Propionate (FP) 100 mcg|Fluticasone propionate (FP) 100 mcg (micrograms) twice daily (BID) via DISKUS inhaler
1222423|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
1222424|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
1222425|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
1222426|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
1222427|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
1222428|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
1222429|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
1222430|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
1222431|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
1222432|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
1222433|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
1222434|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
1222435|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
1222436|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
1222437|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
1222438|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
1222439|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
1222440|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
1222441|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
1222442|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
1222443|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
1222444|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
1222445|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
1222446|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
1222447|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
1222448|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
1222449|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
1222450|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
1222451|NCT00197106|O2|Outcome|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
1222452|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
1222453|NCT00197106|E2|Reported Event|FP 200 mcg|FP 200 mcg BID via DISKUS inhaler
1222454|NCT00197106|E1|Reported Event|Salmeterol/FP 50/100 mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
1222455|NCT00197028|B3|Baseline|Total|Total of all reporting groups
1222456|NCT00197028|B2|Baseline|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222457|NCT00197028|B1|Baseline|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222524|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
1230701|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
1222458|NCT00197028|P2|Participant Flow|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222459|NCT00197028|P1|Participant Flow|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222532|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
1222460|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222461|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222462|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222463|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222464|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222465|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222466|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222467|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222468|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222469|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222470|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222471|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222472|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222473|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222474|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222525|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
1223070|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1222475|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222476|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222477|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222478|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222479|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222480|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222481|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222482|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222483|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222484|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222485|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222486|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222487|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222488|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222489|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222490|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222491|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222526|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
1230707|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
1222492|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222493|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222494|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222495|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222496|NCT00197028|E2|Reported Event|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222497|NCT00197028|E1|Reported Event|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
1222498|NCT00197015|B4|Baseline|Total|Total of all reporting groups
1222499|NCT00197015|B3|Baseline|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
1222500|NCT00197015|B2|Baseline|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
1222501|NCT00197015|B1|Baseline|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
1222502|NCT00197015|P3|Participant Flow|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
1222503|NCT00197015|P2|Participant Flow|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
1222504|NCT00197015|P1|Participant Flow|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
1222505|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
1222506|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
1222507|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
1222508|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
1222509|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
1222510|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
1222511|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
1222512|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
1222513|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
1222514|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
1222515|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
1222516|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
1222517|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
1222518|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
1222519|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
1222520|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
1222521|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
1222522|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
1222523|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
1222527|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
1222528|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
1222529|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
1222530|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
1223081|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1222533|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
1222534|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
1222535|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
1222536|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
1222537|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
1222538|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
1222539|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
1222540|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
1222541|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
1222542|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
1222543|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
1222544|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
1222545|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
1222546|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
1222547|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
1222548|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
1222549|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
1222550|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
1222551|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
1222552|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
1222553|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
1222554|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
1222555|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
1222556|NCT00197015|E3|Reported Event|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
1222557|NCT00197015|E2|Reported Event|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
1222558|NCT00197015|E1|Reported Event|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
1222559|NCT00197002|B4|Baseline|Total|Total of all reporting groups
1222560|NCT00197002|B3|Baseline|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
1222561|NCT00197002|B2|Baseline|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
1222562|NCT00197002|B1|Baseline|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
1222563|NCT00197002|P3|Participant Flow|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
1231171|NCT00150618|O1|Outcome|SPD503 (1 mg)|Guanfacine HCl once daily
1222564|NCT00197002|P2|Participant Flow|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
1222565|NCT00197002|P1|Participant Flow|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
1222566|NCT00197002|O3|Outcome|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
1222861|NCT00196937|E3|Reported Event|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1222567|NCT00197002|O2|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
1222568|NCT00197002|O1|Outcome|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
1222569|NCT00197002|O3|Outcome|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
1222570|NCT00197002|O2|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
1222571|NCT00197002|O1|Outcome|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
1222572|NCT00197002|O3|Outcome|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
1222573|NCT00197002|O2|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
1222574|NCT00197002|O1|Outcome|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
1222575|NCT00197002|O3|Outcome|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
1222576|NCT00197002|O2|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
1222577|NCT00197002|O1|Outcome|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
1222578|NCT00197002|O3|Outcome|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
1222579|NCT00197002|O2|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
1222580|NCT00197002|O1|Outcome|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
1222581|NCT00197002|O3|Outcome|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
1222582|NCT00197002|O2|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
1222583|NCT00197002|O1|Outcome|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
1222584|NCT00197002|O1|Outcome|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
1222585|NCT00197002|O1|Outcome|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
1222586|NCT00197002|O2|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
1222587|NCT00197002|O1|Outcome|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
1222673|NCT00196976|O4|Outcome|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, did not receive any booster vaccination.
1222588|NCT00197002|O2|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
1222589|NCT00197002|O1|Outcome|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
1222590|NCT00197002|O2|Outcome|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
1222591|NCT00197002|O1|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
1222592|NCT00197002|O2|Outcome|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
1222593|NCT00197002|O1|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
1222594|NCT00197002|O2|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
1222595|NCT00197002|O1|Outcome|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
1222596|NCT00197002|O2|Outcome|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
1222597|NCT00197002|O1|Outcome|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
1222598|NCT00197002|E3|Reported Event|Prevnar Havrix Group|Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
1222599|NCT00197002|E2|Reported Event|Havrix+Prevnar Group|Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
1222600|NCT00197002|E1|Reported Event|Havrix Group|Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
1222601|NCT00196976|B15|Baseline|Total|Total of all reporting groups
1222602|NCT00196976|B14|Baseline|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, did not receive any booster vaccination.
1222603|NCT00196976|B13|Baseline|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
1222604|NCT00196976|B12|Baseline|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222605|NCT00196976|B11|Baseline|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222606|NCT00196976|B10|Baseline|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
1222607|NCT00196976|B9|Baseline|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222608|NCT00196976|B8|Baseline|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222609|NCT00196976|B7|Baseline|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222610|NCT00196976|B6|Baseline|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1223071|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1222611|NCT00196976|B5|Baseline|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222857|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
1222999|NCT00196326|B1|Baseline|DR-1011|Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
1222612|NCT00196976|B4|Baseline|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222613|NCT00196976|B3|Baseline|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222614|NCT00196976|B2|Baseline|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222615|NCT00196976|B1|Baseline|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222616|NCT00196976|P14|Participant Flow|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, did not receive any booster vaccination.
1222617|NCT00196976|P13|Participant Flow|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
1222618|NCT00196976|P12|Participant Flow|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222619|NCT00196976|P11|Participant Flow|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222620|NCT00196976|P10|Participant Flow|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
1222621|NCT00196976|P9|Participant Flow|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222622|NCT00196976|P8|Participant Flow|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222623|NCT00196976|P7|Participant Flow|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222624|NCT00196976|P6|Participant Flow|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222625|NCT00196976|P5|Participant Flow|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222674|NCT00196976|O3|Outcome|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
1222856|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1222626|NCT00196976|P4|Participant Flow|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222627|NCT00196976|P3|Participant Flow|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222628|NCT00196976|P2|Participant Flow|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222629|NCT00196976|P1|Participant Flow|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222630|NCT00196976|O4|Outcome|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, did not receive any booster vaccination.
1222631|NCT00196976|O3|Outcome|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
1222632|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222633|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222634|NCT00196976|O10|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
1222635|NCT00196976|O9|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222636|NCT00196976|O8|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222637|NCT00196976|O7|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222638|NCT00196976|O6|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222639|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222640|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222641|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222642|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222643|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222644|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222645|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222646|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222647|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222648|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222649|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222650|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222651|NCT00196976|O10|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
1222652|NCT00196976|O9|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222653|NCT00196976|O8|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222654|NCT00196976|O7|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222655|NCT00196976|O6|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222656|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1231172|NCT00150618|O5|Outcome|Placebo|once daily
1222657|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222658|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222659|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222660|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222661|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222662|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222663|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222664|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222665|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222666|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222667|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222668|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222669|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222670|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222671|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222672|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222846|NCT00196937|O3|Outcome|Cervarix (26-45 Years) Group|Women of 26-45 years of age received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule
1222675|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222858|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women of 46-55 years of age received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule
1222676|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222677|NCT00196976|O4|Outcome|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, did not receive any booster vaccination.
1222678|NCT00196976|O3|Outcome|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
1222679|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222680|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222681|NCT00196976|O4|Outcome|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, did not receive any booster vaccination.
1222682|NCT00196976|O3|Outcome|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
1222683|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222684|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222685|NCT00196976|O4|Outcome|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, did not receive any booster vaccination.
1222686|NCT00196976|O3|Outcome|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
1222687|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222688|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222689|NCT00196976|O4|Outcome|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, did not receive any booster vaccination.
1222690|NCT00196976|O3|Outcome|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
1222691|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222692|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222693|NCT00196976|O4|Outcome|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, did not receive any booster vaccination.
1222694|NCT00196976|O3|Outcome|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
1222847|NCT00196937|O2|Outcome|Cervarix (15-25 Years) Group|Women of 15-25 years of age received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule
1222695|NCT00196976|O2|Outcome|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222696|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222697|NCT00196976|O5|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
1222698|NCT00196976|O4|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222699|NCT00196976|O3|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222700|NCT00196976|O2|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222701|NCT00196976|O1|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222702|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222703|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222704|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222705|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222706|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222707|NCT00196976|O5|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
1222708|NCT00196976|O4|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222709|NCT00196976|O3|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222710|NCT00196976|O2|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222711|NCT00196976|O1|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222859|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women of 26-45 years of age received 3 doses of Cervarix™ (HPV vaccine)administered according to a 0, 1, 6-month schedule
1222860|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women of 15-25 years of age received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine)administered according to a 0, 1, 6-month schedule
1222712|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222713|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222714|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222715|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222716|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222717|NCT00196976|O10|Outcome|Control (C), Primary Group|Healthy male and female childrens (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
1222718|NCT00196976|O9|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female childrens (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222719|NCT00196976|O8|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female childrens (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222720|NCT00196976|O7|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female childrens (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222721|NCT00196976|O6|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female childrens (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222722|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222723|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222724|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222725|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222848|NCT00196937|O1|Outcome|Cervarix (46-55 Years) Group|Women of 46-55 years of age received 3 doses of Cervarix™ (HPV vaccine)administered according to a 0, 1, 6-month schedule
1231173|NCT00150618|O4|Outcome|SPD503 (4 mg)|Guanfacine HCl once daily
1222726|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222727|NCT00196976|O10|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
1222728|NCT00196976|O9|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222729|NCT00196976|O8|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222730|NCT00196976|O7|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222731|NCT00196976|O6|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222732|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222733|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222734|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222735|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222736|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222737|NCT00196976|O10|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
1222738|NCT00196976|O9|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222739|NCT00196976|O8|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222740|NCT00196976|O7|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222741|NCT00196976|O6|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222849|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1222742|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222743|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222744|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222745|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222746|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222747|NCT00196976|O10|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
1222748|NCT00196976|O9|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222749|NCT00196976|O8|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222750|NCT00196976|O7|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222751|NCT00196976|O6|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222752|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222753|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222754|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222755|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222850|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1231174|NCT00150618|O3|Outcome|SPD503 (3 mg)|Guanfacine HCl once daily
1222756|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222757|NCT00196976|O10|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
1222758|NCT00196976|O9|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222759|NCT00196976|O8|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222760|NCT00196976|O7|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222761|NCT00196976|O6|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222762|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222763|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222764|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222765|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222766|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222767|NCT00196976|O10|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
1222768|NCT00196976|O9|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222769|NCT00196976|O8|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222770|NCT00196976|O7|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222771|NCT00196976|O6|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222851|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
1222772|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222773|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222774|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222775|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222776|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222777|NCT00196976|O10|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
1222778|NCT00196976|O9|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222779|NCT00196976|O8|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222780|NCT00196976|O7|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222781|NCT00196976|O6|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222782|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222783|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222784|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222785|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222852|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women of 46-55 years of age received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule
1231175|NCT00150618|O2|Outcome|SPD503 (2 mg)|Guanfacine HCl once daily
1222786|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222787|NCT00196976|O10|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
1222788|NCT00196976|O9|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222789|NCT00196976|O8|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222790|NCT00196976|O7|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222791|NCT00196976|O6|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222792|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222793|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222794|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222795|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222796|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222797|NCT00196976|O10|Outcome|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
1222798|NCT00196976|O9|Outcome|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222799|NCT00196976|O8|Outcome|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222800|NCT00196976|O7|Outcome|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222801|NCT00196976|O6|Outcome|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222853|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women of 26-45 years of age received 3 doses of Cervarix™ (HPV vaccine)administered according to a 0, 1, 6-month schedule
1222802|NCT00196976|O5|Outcome|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222803|NCT00196976|O4|Outcome|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222804|NCT00196976|O3|Outcome|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222805|NCT00196976|O2|Outcome|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222806|NCT00196976|O1|Outcome|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222807|NCT00196976|E14|Reported Event|Control (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, did not receive any booster vaccination.
1222808|NCT00196976|E13|Reported Event|GSK134612A Form1 (C), Booster Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
1222809|NCT00196976|E12|Reported Event|Control (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222810|NCT00196976|E11|Reported Event|GSK134612A Form1 (T), Booster Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
1222811|NCT00196976|E10|Reported Event|Control (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
1222812|NCT00196976|E9|Reported Event|GSK134612A Form4 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222813|NCT00196976|E8|Reported Event|GSK134612A Form3 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222814|NCT00196976|E7|Reported Event|GSK134612A Form2 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222815|NCT00196976|E6|Reported Event|GSK134612A Form1 (C), Primary Group|Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).
1222816|NCT00196976|E5|Reported Event|Control (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec™ conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222854|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women of 15-25 years of age received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine)administered according to a 0, 1, 6-month schedule
1222855|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1223065|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1222817|NCT00196976|E4|Reported Event|GSK134612A Form4 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222818|NCT00196976|E3|Reported Event|GSK134612A Form3 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222819|NCT00196976|E2|Reported Event|GSK134612A Form2 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222820|NCT00196976|E1|Reported Event|GSK134612A Form1 (T), Primary Group|Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
1222821|NCT00196937|B4|Baseline|Total|Total of all reporting groups
1222822|NCT00196937|B3|Baseline|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1222823|NCT00196937|B2|Baseline|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1222824|NCT00196937|B1|Baseline|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
1222825|NCT00196937|P3|Participant Flow|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1222826|NCT00196937|P2|Participant Flow|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1222827|NCT00196937|P1|Participant Flow|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
1222828|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1222829|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1222830|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
1222831|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1222832|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1222833|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
1222834|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1222835|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1222836|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
1222837|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1222838|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1222839|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
1222840|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1222841|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1222842|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
1222843|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1222844|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1222845|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
1222862|NCT00196937|E2|Reported Event|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
1222863|NCT00196937|E1|Reported Event|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
1222864|NCT00197496|B3|Baseline|Total|Total of all reporting groups
1222865|NCT00197496|B2|Baseline|Control|Usual care
1222866|NCT00197496|B1|Baseline|BWSTT|Body weight supported treadmill training
1222867|NCT00197496|P2|Participant Flow|Control|Usual care
1222868|NCT00197496|P1|Participant Flow|BWSTT|Body weight supported treadmill training
1222869|NCT00197496|O2|Outcome|Control|Usual care
1222870|NCT00197496|O1|Outcome|BWSTT|Body weight supported treadmill training
1222871|NCT00197496|O2|Outcome|Control|Usual care
1222872|NCT00197496|O1|Outcome|BWSTT|Body weight supported treadmill training
1222873|NCT00197496|O2|Outcome|Control|Usual care
1222874|NCT00197496|O1|Outcome|BWSTT|Body weight supported treadmill training
1222875|NCT00197496|O2|Outcome|Control|Usual care
1222876|NCT00197496|O1|Outcome|BWSTT|Body weight supported treadmill training
1222877|NCT00197496|O1|Outcome|BWSTT|Body weight supported treadmill training
1222878|NCT00197496|E2|Reported Event|Usual Care|Usual care rehabilitation
1222879|NCT00197496|E1|Reported Event|BWSTT|Body weight supported treadmill training: hip fracture patients walk on a treadmill with body weight support
1222880|NCT00197392|B3|Baseline|Total|Total of all reporting groups
1222881|NCT00197392|B2|Baseline|Standard EVD|
1222882|NCT00197392|B1|Baseline|Bactiseal EVD|
1222883|NCT00197392|P2|Participant Flow|Conventional EVD Catheter|Subjects treated with Standard EVD catheter
1222884|NCT00197392|P1|Participant Flow|Bactiseal EVD|Subjects treated with Bactiseal EVD catheter
1222885|NCT00197392|O2|Outcome|Standard EVD|Subjects implanted with Standard EVD catheters.
1222886|NCT00197392|O1|Outcome|Bactiseal EVD|Subjects implanted with Bactiseal EVD catheters.
1222887|NCT00197392|O2|Outcome|Standard EVD Catheter|Subjects implanted with a standard EVD catheter
1222888|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Subjects implanted with Bactiseal EVD Catheter
1222889|NCT00197392|O2|Outcome|Standard EVD Catheter|Subjects implanted with a standard EVD catheter
1222890|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Subjects implanted with the Bactiseal EVD Catheter
1222891|NCT00197392|O2|Outcome|Standrad EVD Catheter|Subjects implanted with standard EVD catheter
1222892|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Subjects implanted with Bactiseal EVD Catheter
1222893|NCT00197392|O2|Outcome|Standard EVD Catheter|Subjects treated with standard EVD catheter
1222894|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Subjects treated with Bactiseal EVD Catheter
1222895|NCT00197392|O1|Outcome|Bactiseal EVD Catheter and Standard EVD Cathter|Patients implanted with Bactiseal EVD Catheter or Standard EVD Catheter.
1222896|NCT00197392|O2|Outcome|Standard EVD Catheter|Subjects implanted with standard EVD catheter
1222897|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Subjects implanted with Bactiseal EVD Catheter
1222898|NCT00197392|O2|Outcome|Standard EVD Catheter|Patients implanted with Standard EVD Catheter
1222899|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Patients implanted with Bactiseal EVD Catheter
1222900|NCT00197392|O2|Outcome|Standard EVD Catheter|Patients implanted with standard EVD catheter
1222901|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Patients implanted with Bactiseal EVD Catheter
1222902|NCT00197392|O2|Outcome|Standard EVD Catheter|Patients implanted with Standard EVD Catheter
1222903|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Patients implanted with Bactiseal EVD Catheter
1222904|NCT00197392|O2|Outcome|Standard EVD Catheter|Patient treated with Standard EVD Catheter
1222905|NCT00197392|O1|Outcome|Bactiseal - EVD Catheter|Patients treated with Bactiseal EVD catheter
1222906|NCT00197392|O2|Outcome|Standard EVD Catheter|Patients treated with standard EVD catheter.
1222907|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Patients treated with Codman Bactiseal EVD Catheter
1222908|NCT00197392|O2|Outcome|Standard EVD Cathter|Patients treated with Standard EVD Catheter
1222909|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Patients treated with Codman Bactiseal EVD Catheter
1222910|NCT00197392|E2|Reported Event|Bactiseal EVD|Subjects with Bactiseal EVD
1222911|NCT00197392|E1|Reported Event|Standard EVD|Subjects with standard EVD
1222912|NCT00197236|B4|Baseline|Total|Total of all reporting groups
1222913|NCT00197236|B3|Baseline|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
1222914|NCT00197236|B2|Baseline|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
1222915|NCT00197236|B1|Baseline|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
1222916|NCT00197236|P3|Participant Flow|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
1222917|NCT00197236|P2|Participant Flow|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
1222918|NCT00197236|P1|Participant Flow|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
1222919|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
1222920|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
1222921|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
1222922|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
1222923|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
1222924|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
1222925|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
1222926|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
1222927|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
1222928|NCT00197236|O3|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
1222929|NCT00197236|O2|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
1222930|NCT00197236|O1|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
1222931|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
1222932|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
1222933|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
1222934|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
1222935|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
1222936|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
1222937|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
1222938|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
1222939|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
1222940|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
1222941|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
1222942|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
1222943|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
1222944|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
1222945|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
1222946|NCT00197236|O3|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
1222947|NCT00197236|O2|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
1222948|NCT00197236|O1|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
1222949|NCT00197236|O3|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
1222950|NCT00197236|O2|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
1222951|NCT00197236|O1|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
1222952|NCT00197236|O3|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
1222953|NCT00197236|O2|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
1223066|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1222954|NCT00197236|O1|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
1222955|NCT00197236|O3|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
1222956|NCT00197236|O2|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
1222957|NCT00197236|O1|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
1223000|NCT00196326|P1|Participant Flow|DR-1011|Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
1222958|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
1222959|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
1222960|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
1222961|NCT00197236|E3|Reported Event|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
1222962|NCT00197236|E2|Reported Event|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
1222963|NCT00197236|E1|Reported Event|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
1222964|NCT00197184|B3|Baseline|Total|Total of all reporting groups
1222965|NCT00197184|B2|Baseline|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
1222966|NCT00197184|B1|Baseline|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
1222967|NCT00197184|P2|Participant Flow|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
1222968|NCT00197184|P1|Participant Flow|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
1222969|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
1222970|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
1222971|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
1222972|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
1222973|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
1222974|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
1222975|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
1222976|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
1222977|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
1222978|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
1222979|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
1222980|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
1222981|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
1222982|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
1222983|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
1222984|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
1222985|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
1222986|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
1222987|NCT00197184|E2|Reported Event|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
1222988|NCT00197184|E1|Reported Event|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
1222989|NCT00196716|B1|Baseline|Fabrazyme|Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months.
1222990|NCT00196716|P1|Participant Flow|Fabrazyme|Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months.
1222991|NCT00196716|O1|Outcome|Fabrazyme|Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months.
1222992|NCT00196716|O1|Outcome|Fabrazyme|Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months.
1222993|NCT00196716|O1|Outcome|Fabrazyme|Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months.
1223067|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1231176|NCT00150618|O1|Outcome|SPD503 (1 mg)|Guanfacine HCl once daily
1222994|NCT00196716|O1|Outcome|Fabrazyme|Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months.
1222995|NCT00196716|O1|Outcome|Fabrazyme|Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months.
1222996|NCT00196716|E3|Reported Event|Total|
1222997|NCT00196716|E2|Reported Event|0.3 mg/kg Fabrazyme|0.3 mg/kg Fabrazyme, Week 24 to Week 96.
1222998|NCT00196716|E1|Reported Event|1.0 mg/kg Fabrazyme|1.0 mg/kg Fabrazyme, Week 0 to Week 24.
1223001|NCT00196326|O1|Outcome|DR-1011|Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
1223002|NCT00196326|O1|Outcome|DR-1011|Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
1223003|NCT00196326|O1|Outcome|DR-1011|Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
1223004|NCT00196326|E1|Reported Event|DR-1011|Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
1223005|NCT00196313|B3|Baseline|Total|Total of all reporting groups
1223006|NCT00196313|B2|Baseline|Placebo|Placebo, 1 tablet daily
1223007|NCT00196313|B1|Baseline|Seasonique|"Seasonique~, 1 tablet daily"
1223008|NCT00196313|P2|Participant Flow|Placebo|Placebo, 1 tablet daily
1223009|NCT00196313|P1|Participant Flow|Seasonique|"Seasonique~, 1 tablet daily"
1223010|NCT00196313|O2|Outcome|Placebo|Placebo, 1 tablet daily
1223011|NCT00196313|O1|Outcome|Seasonique|Seasonique, 1 tablet daily
1223012|NCT00196313|O2|Outcome|Placebo|Placebo, 1 tablet daily
1223013|NCT00196313|O1|Outcome|Seasonique|"Seasonique~, 1 tablet daily"
1223014|NCT00196313|O2|Outcome|Placebo|Placebo, 1 tablet daily
1223015|NCT00196313|O1|Outcome|Seasonique|Seasonique, 1 tablet daily
1223016|NCT00196313|O2|Outcome|Placebo|Placebo, 1 tablet daily
1223017|NCT00196313|O1|Outcome|Seasonique|"Seasonique~, 1 tablet daily"
1223018|NCT00196313|O2|Outcome|Placebo|Placebo, 1 tablet daily
1223019|NCT00196313|O1|Outcome|Seasonique|"Seasonique~, 1 tablet daily"
1223020|NCT00196313|E2|Reported Event|Placebo|Placebo, 1 tablet daily
1223021|NCT00196313|E1|Reported Event|Seasonique|"Seasonique~, 1 tablet daily"
1223022|NCT00196196|B1|Baseline|Codman VPV System|
1223023|NCT00196196|P1|Participant Flow|Codman VPV System|
1223024|NCT00196196|O1|Outcome|Codman VPV System|
1223025|NCT00196196|O1|Outcome|Codman VPV System|
1223026|NCT00196196|E1|Reported Event|Codman VPV System|
1223027|NCT00196105|B4|Baseline|Total|Total of all reporting groups
1223028|NCT00196105|B3|Baseline|10 mm Wallstent|10 mm Stainless Steel Wallstent
1223029|NCT00196105|B2|Baseline|10 mm Zilver|10 mm Nitinol Zilver Stent
1223030|NCT00196105|B1|Baseline|6 mm Zilver|6 mm Nitinol Zilver Stent
1223031|NCT00196105|P3|Participant Flow|10 mm Wallstent|10 mm Stainless Steel Wallstent
1223032|NCT00196105|P2|Participant Flow|10 mm Zilver|10 mm Nitinol Zilver Stent
1223033|NCT00196105|P1|Participant Flow|6 mm Zilver|6 mm Nitinol Zilver Stent
1223034|NCT00196105|O3|Outcome|10 mm Wallstent|10 mm Stainless Steel Wallstent
1223035|NCT00196105|O2|Outcome|10 mm Zilver|10 mm Nitinol Zilver Stent
1223036|NCT00196105|O1|Outcome|6 mm Zilver|6 mm Nitinol Zilver Stent
1223037|NCT00196105|O3|Outcome|10 mm Wallstent|10 mm Stainless Steel Wallstent
1223038|NCT00196105|O2|Outcome|10 mm Zilver|10 mm Nitinol Zilver Stent
1223039|NCT00196105|O1|Outcome|6 mm Zilver|6 mm Nitinol Zilver Stent
1223040|NCT00196105|O3|Outcome|10 mm Wallstent|10 mm Stainless Steel Wallstent
1223041|NCT00196105|O2|Outcome|10 mm Zilver|10 mm Nitinol Zilver Stent
1223042|NCT00196105|O1|Outcome|6 mm Zilver|6 mm Nitinol Zilver Stent
1223043|NCT00196105|O3|Outcome|10 mm Wallstent|10 mm Stainless Steel Wallstent
1223044|NCT00196105|O2|Outcome|10 mm Zilver|10 mm Nitinol Zilver Stent
1223045|NCT00196105|O1|Outcome|6 mm Zilver|6 mm Nitinol Zilver Stent
1223046|NCT00196105|O3|Outcome|10 mm Wallstent|10 mm Stainless Steel Wallstent
1223047|NCT00196105|O2|Outcome|10 mm Zilver|10 mm Nitinol Zilver Stent
1223048|NCT00196105|O1|Outcome|6 mm Zilver|6 mm Nitinol Zilver Stent
1223049|NCT00196105|E3|Reported Event|10 mm Wallstent|10 mm Stainless Steel Wallstent
1223050|NCT00196105|E2|Reported Event|10 mm Zilver|10 mm Nitinol Zilver Stent
1223051|NCT00196105|E1|Reported Event|6 mm Zilver|6 mm Nitinol Zilver Stent
1223052|NCT00195819|B1|Baseline|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1223053|NCT00195819|P2|Participant Flow|Any Adalimumab|40 mg every other week (eow), subcutaneous (SC)
1223054|NCT00195819|P1|Participant Flow|Placebo 40 mg Every Other Week (Eow), Subcutaneous (SC)|
1223055|NCT00195819|O1|Outcome|Any Adalimumab|By duration of exposure to adalimumab 40 mg every other week, subcutaneous
1223056|NCT00195819|O2|Outcome|Placebo|(Week 52 - placebo plus up to 40 weeks of adalimumab)
1223057|NCT00195819|O1|Outcome|Adalimumab Exposure|Adalimumab 40 mg every other week (eow)
1223058|NCT00195819|O2|Outcome|Placebo|(Week 52 - Placebo plus up to 40 weeks adalimumab)
1223059|NCT00195819|O1|Outcome|Adalimumab|Adalimumab every other week (eow)
1223060|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1223061|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1223062|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1223063|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1223064|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1223072|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1223073|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1223074|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1223075|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1223076|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1223077|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1223078|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1223079|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1223080|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1223082|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1223083|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1223084|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1223085|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1223086|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1223087|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1223088|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1223089|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1223090|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1223091|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1223092|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1223093|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1223094|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1223095|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1223096|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1223097|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1223098|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1223099|NCT00195819|O1|Outcome|Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1223100|NCT00195819|O2|Outcome|Placebo|40 mg every other week, subcutaneous
1223101|NCT00195819|O1|Outcome|Adalimumab|40 mg every other week, subcutaneous
1223102|NCT00195819|E1|Reported Event|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1223103|NCT00195715|B1|Baseline|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
1223104|NCT00195715|P1|Participant Flow|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
1223105|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
1223106|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
1223107|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
1223108|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
1223109|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
1223110|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
1223111|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
1223112|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
1223113|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
1223114|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
1223115|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
1223116|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
1223117|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
1223118|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
1223119|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
1223120|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
1223121|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
1223122|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
1223123|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
1223124|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
1223125|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
1223126|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
1223127|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
1223128|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
1223129|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
1223130|NCT00195715|E1|Reported Event|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
1223131|NCT00195702|B4|Baseline|Total|Total of all reporting groups
1223132|NCT00195702|B3|Baseline|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
1223133|NCT00195702|B2|Baseline|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
1223134|NCT00195702|B1|Baseline|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
1223135|NCT00195702|P6|Participant Flow|DB Placebo ew/OL Adalimumab 40 mg Eow|Subjects received placebo weekly (ew) during the double-blind (DB) phase, then received adalimumab 40 mg every other week (eow) during the open-label (OL) extension phase. Subjects received concomitant methotrexate (MTX) during both phases of the study.
1223169|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
1223420|NCT00195338|O1|Outcome|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
1223136|NCT00195702|P5|Participant Flow|DB Adalimumab 40 mg Eow/OL Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) during the double-blind (DB) phase, then received adalimumab 40 mg every other week (eow) during the open-label (OL) extension phase. Subjects received concomitant methotrexate (MTX) during both phases of the study.
1223137|NCT00195702|P4|Participant Flow|DB Adalimumab 20 mg ew/OL Adalimumab 40 mg Eow|Subjects received adalimumab 20 mg weekly (ew) during the double-blind (DB) phase, then received adalimumab 40 mg every other week (eow) during the open-label (OL) extension phase. Subjects received concomitant methotrexate (MTX) during both phases of the study.
1223138|NCT00195702|P3|Participant Flow|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
1223139|NCT00195702|P2|Participant Flow|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
1223140|NCT00195702|P1|Participant Flow|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
1223141|NCT00195702|O3|Outcome|DB Placebo ew/OL Adalimumab 40 mg Eow|Subjects received placebo every week (ew) during the double-blind (DB) phase, followed by adalimumab 40 mg every other week (eow) during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).
1223142|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow/OL Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) during the double-blind (DB) phase, followed by adalimumab 40 mg eow during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).
1223143|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew/OL Adalimumab 40 mg Eow|Subjects received adalimumab 20 mg every week (ew) during the double-blind (DB) phase, followed by adalimumab every other week (eow) during the open-label (OL) extension, along with concomitant methotrexate (MTX).
1223144|NCT00195702|O3|Outcome|DB Placebo ew/OL Adalimumab 40 mg Eow|Subjects received placebo every week (ew) during the double-blind (DB) phase, followed by adalimumab 40 mg every other week (eow) during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).
1223145|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow/OL Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) during the double-blind (DB) phase, followed by adalimumab 40 mg eow during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).
1223146|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew/OL Adalimumab 40 mg Eow|Subjects received adalimumab 20 mg every week (ew) during the double-blind (DB) phase, followed by adalimumab every other week (eow) during the open-label (OL) extension, along with concomitant methotrexate (MTX).
1223147|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
1223148|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
1223149|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
1223150|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
1223151|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
1223152|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
1223153|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
1223154|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
1223155|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
1223156|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
1223157|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
1223158|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
1223159|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
1223160|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
1223161|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
1223162|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
1223163|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
1223164|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
1223165|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
1223166|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
1223167|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
1223168|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
1223170|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
1223171|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
1223172|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
1223173|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
1223174|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
1223175|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
1223176|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
1223177|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
1223178|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
1223179|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
1223180|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
1223181|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
1223182|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
1223183|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
1223184|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
1223185|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
1223186|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
1223187|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
1223188|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
1223189|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
1223190|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
1223191|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
1223192|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
1223193|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
1223194|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
1223195|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
1223196|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
1223197|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
1223198|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
1223199|NCT00195702|E4|Reported Event|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
1223200|NCT00195702|E3|Reported Event|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
1223201|NCT00195702|E2|Reported Event|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
1223202|NCT00195702|E1|Reported Event|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
1223203|NCT00195676|B1|Baseline|All Adalimumab Treatment|All participants in the study who received at least one dose of adalimumab. In this study, participants were treated with adalimumab 40 mg every other week (eow) or 40 mg every week by subcutaneous injection (SC) in Period O and then were retreated with open-label adalimumab 40 mg eow SC (after an 80 mg initial dose) in Period R after withdrawal from adalimumab treatment in Period W.
1223204|NCT00195676|P1|Participant Flow|All Adalimumab Treatment|All participants in the study who received at least one dose of adalimumab. In this study, participants were treated with adalimumab 40 mg every other week (eow) or 40 mg every week by subcutaneous injection (SC) in Period O and then were retreated with open-label adalimumab 40 mg eow SC (after an 80 mg initial dose) in Period R after withdrawal from adalimumab treatment in Period W.
1223205|NCT00195676|O1|Outcome|Period R Modified Intent-to-Treat Not Relapsed in Period W|A subset of the Period R modified Intent-to-Treat (mITT) population who had not relapsed (i.e., PGA not greater than or equal to 3) in Period W after adalimumab therapy was withdrawn.
1223206|NCT00195676|O1|Outcome|Period R mITT Population Relapsed in Period W|A subset of the Period R modified Intent-to-Treat (mITT) population who had relapsed in Period W after adalimumab therapy was withdrawn.
1223207|NCT00195676|O1|Outcome|Period W Modified Intent-to-treat Population|Participants from Period O who entered Period W with a PGA of 0 or 1 for the last 2 consecutive visits of Period O, at least 12 weeks apart, and received adalimumab 40 mg every other week for at least 12 weeks prior to entering Period W.
1223208|NCT00195676|O1|Outcome|Period O Adalimumab EOW Treatment Population|Participants in the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study.
1223209|NCT00195676|O1|Outcome|Period O Adalimumab EOW Treatment Population|Participants in the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study.
1223210|NCT00195676|O1|Outcome|Period R Modified Intent-to-Treat Population|Participants of the Period W Modified Intent-to-Treat(mITT) Population who received at least one retreatment dose of adalimumab 40 mg every other week in Period R. The Period W mITT Population had entered Period W from Period O with stable psoriasis control [i.e., had a PGA of 0 or 1 at the last 2 consecutive visits in Period O, at least 12 weeks apart, and were on adalimumab 40 mg every other week for the last 12 weeks of Period O).
1223211|NCT00195676|O1|Outcome|Period O Adalimumab EOW Treatment Population|Participants in the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study.
1223212|NCT00195676|O1|Outcome|Period O Adalimumab EOW Treatment Population|Participants in the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study.
1223213|NCT00195676|E1|Reported Event|All Adalimumab Treatment|All participants in the study who received at least one dose of adalimumab. In this study, participants were treated with adalimumab 40 mg every other week (eow) or 40 mg every week by subcutaneous injection (SC) in Period O and then were retreated with open-label adalimumab 40 mg eow SC (after an 80 mg initial dose) in Period R after withdrawal from adalimumab treatment in Period W.
1223214|NCT00195663|B4|Baseline|Total|Total of all reporting groups
1223215|NCT00195663|B3|Baseline|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
1223216|NCT00195663|B2|Baseline|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase and then adalimumab 40 mg every other week for up to 8 years in the open-label extension.
1223217|NCT00195663|B1|Baseline|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
1223218|NCT00195663|P3|Participant Flow|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
1223219|NCT00195663|P2|Participant Flow|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase and then adalimumab 40 mg every other week for up to 8 years in the open-label extension.
1223220|NCT00195663|P1|Participant Flow|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
1223221|NCT00195663|O2|Outcome|Adalimumab: HAQ Decrease ≥ 0.5|Participants with a decrease of least 0.5 in HAQ from baseline, who received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase and adalimumab 40 mg every other week during the 8-year open-label phase.
1223222|NCT00195663|O1|Outcome|Adalimumab: HAQ Decrease ≥ 0.22|Participants with a decrease of least 0.22 in HAQ from baseline, who received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase and adalimumab 40 mg every other week during the 8-year open-label phase.
1223223|NCT00195663|O1|Outcome|Any Adalimumab|Participants received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase. During the 8-year open-label phase all participants received adalimumab 40 mg every other week.
1223224|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
1231177|NCT00150618|O5|Outcome|Placebo|once daily
1223225|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase and then adalimumab 40 mg every other week for up to 8 years in the open-label extension.
1223226|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
1223227|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
1241312|NCT00117338|E2|Reported Event|Placebo|
1223228|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase and then adalimumab 40 mg every other week for up to 8 years in the open-label extension.
1223229|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
1223230|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
1223231|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase and then adalimumab 40 mg every other week for up to 8 years in the open-label extension.
1223232|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
1223233|NCT00195663|O2|Outcome|Adalimumab: DAS28 < 3.2|Participants with a DAS28 score less than 3.2, who received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase and adalimumab 40 mg every other week during the 8-year open-label phase.
1223234|NCT00195663|O1|Outcome|Adalimumab: DAS28 < 2.6|Participants with a DAS28 score less than 2.6, who received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase and adalimumab 40 mg every other week during the 8-year open-label phase.
1223235|NCT00195663|O1|Outcome|Any Adalimumab|Participants received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase. During the 8-year open-label phase all participants received adalimumab 40 mg every other week.
1223236|NCT00195663|O1|Outcome|Any Adalimumab|Participants received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase. During the 8-year open-label phase all participants received adalimumab 40 mg every other week.
1223237|NCT00195663|O1|Outcome|Any Adalimumab|Participants received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase. During the 8-year open-label phase all participants received adalimumab 40 mg every other week.
1223238|NCT00195663|O1|Outcome|Any Adalimumab|Participants received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase. During the 8-year open-label phase all participants received adalimumab 40 mg every other week.
1223239|NCT00195663|O1|Outcome|Any Adalimumab|Participants received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase. During the 8-year open-label phase all participants received adalimumab 40 mg every other week.
1223240|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223241|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
1223242|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223243|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223244|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
1223245|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223246|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223247|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
1223248|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223249|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223250|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
1223251|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223252|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223253|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
1223254|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223255|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223256|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
1223257|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223258|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223259|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
1223260|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223261|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223262|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
1223263|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223264|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223265|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
1223266|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223267|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223268|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
1223269|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223270|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223271|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
1223272|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223273|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223274|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
1223275|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223276|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223277|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
1223278|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223279|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223280|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
1223281|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223282|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223283|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
1223284|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223285|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223286|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
1223287|NCT00195663|O1|Outcome|Methotrexate Weekly|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223288|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223289|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
1223290|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223291|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223292|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
1223293|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223294|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223295|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
1223296|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223297|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223298|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
1223299|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223300|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223301|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
1223302|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223303|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223304|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
1223305|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223306|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223307|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
1223308|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223309|NCT00195663|E4|Reported Event|Any Adalimumab|"Participants received either methotrexate, adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase. During the 8-year open-label phase all participants received adalimumab 40 mg every other week.~Adverse events reported include those that occurred at any time during adalimumab exposure (up to 10 years)."
1223310|NCT00195663|E3|Reported Event|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223311|NCT00195663|E2|Reported Event|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
1223312|NCT00195663|E1|Reported Event|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
1223313|NCT00195650|B1|Baseline|Adalimumab|Open-label adalimumab 40 mg
1223314|NCT00195650|P1|Participant Flow|Adalimumab|Open-label adalimumab 40 mg
1223315|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
1223316|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
1223317|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
1223318|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
1223319|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
1223320|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
1223321|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
1223322|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
1223323|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
1223324|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
1223325|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
1223326|NCT00195650|E1|Reported Event|Adalimumab|Open-label adalimumab 40 mg
1223327|NCT00195507|B3|Baseline|Total|Total of all reporting groups
1223328|NCT00195507|B2|Baseline|Intermittent|etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
1223329|NCT00195507|B1|Baseline|Continuous|etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
1223330|NCT00195507|P2|Participant Flow|Intermittent|etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
1223331|NCT00195507|P1|Participant Flow|Continuous|etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
1223332|NCT00195507|O2|Outcome|Intermittent|etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
1223333|NCT00195507|O1|Outcome|Continuous|etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
1223334|NCT00195507|O2|Outcome|Intermittent|etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
1223335|NCT00195507|O1|Outcome|Continuous|etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
1223336|NCT00195507|O2|Outcome|Intermittent|etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
1223337|NCT00195507|O1|Outcome|Continuous|etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
1223338|NCT00195507|O2|Outcome|Intermittent|etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
1223339|NCT00195507|O1|Outcome|Continuous|etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
1223340|NCT00195507|E2|Reported Event|Intermittent|etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
1223341|NCT00195507|E1|Reported Event|Continuous|etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
1223342|NCT00195494|B3|Baseline|Total|Total of all reporting groups
1223372|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
1231178|NCT00150618|O4|Outcome|SPD503 (4 mg)|Guanfacine HCl once daily
1223343|NCT00195494|B2|Baseline|Year 1 E+M|"Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).~MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
1223344|NCT00195494|B1|Baseline|Year 1 M+Placebo|"Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites.~MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
1223345|NCT00195494|P6|Participant Flow|Year 1 E+M|"Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).~MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
1223346|NCT00195494|P5|Participant Flow|Year 1 M+Placebo|"Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites.~MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
1223347|NCT00195494|P4|Participant Flow|Year 1 M / Year 2 M|"Following a blinded transition from year one- Methotrexate dose consistent with the ending dose of year one (usually 20 mgs).~No reduction of MTX dose is permitted in year two."
1223348|NCT00195494|P3|Participant Flow|Year 1 E+M / Year 2 E|Following a blinded transition from year one-Etanercept two injections 25 mg weekly (given at the same time at different sites).
1223349|NCT00195494|P2|Participant Flow|Year 1 M / Year 2 E+M|"Following a blinded transition from year one- Etanercept two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).~Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two."
1223350|NCT00195494|P1|Participant Flow|Year 1 E+M / Year 2 E+M|"Following a blinded transition from year one- Etanercept injection- two injections 25 mg weekly (given at the same time at different sites)+ oral Methotrexate capsules weekly (same day as injection).~Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two."
1223351|NCT00195494|O6|Outcome|Year 1 E+M|"Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).~MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
1223352|NCT00195494|O5|Outcome|Year 1 M+Placebo|"Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites.~MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
1223353|NCT00195494|O4|Outcome|Year 2 M / M|"Following a blinded transition from year one- MTX dose consistent with the ending dose of year one (usually 20 mgs).~No reduction of MTX dose is permitted in year two."
1223354|NCT00195494|O3|Outcome|Year 2 E+M / E|Following a blinded transition from year one-Etanercept two injections 25 mg weekly (given at the same time at different sites).
1223355|NCT00195494|O2|Outcome|Year 2 M / E+M|"Following a blinded transition from year one- Etanercept two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).~Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two."
1223356|NCT00195494|O1|Outcome|Year 2 E+M / E+M|"Following a blinded transition from year one- Etanercept injection- two injections 25 mg weekly (given at the same time at different sites)+ oral Methotrexate capsules weekly (same day as injection).~Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two."
1223357|NCT00195494|O2|Outcome|Year 1 E+M|etanercept injection 50mg once weekly and oral methotrexate capsules 7.5 mg once weekly at the same time
1223358|NCT00195494|O1|Outcome|Year 1 M|Oral methotrexate capsules 7.5mg weekly and etanercept placebo at the same day and time.
1223359|NCT00195494|O2|Outcome|Year 1 E+M|etanercept injection 50mg once weekly and oral methotrexate capsules 7.5 mg once weekly at the same time
1223360|NCT00195494|O1|Outcome|Year 1 M|Oral methotrexate capsules 7.5mg weekly and etanercept placebo at the same day and time.
1223361|NCT00195494|E6|Reported Event|Year 1 E+M|"Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).~MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
1223362|NCT00195494|E5|Reported Event|Year 1 M+Placebo|"Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites.~MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
1223363|NCT00195494|E4|Reported Event|Year 1 M / Year 2 M|"Following a blinded transition from year one- Methotrexate dose consistent with the ending dose of year one (usually 20 mgs).~No reduction of MTX dose is permitted in year two."
1223364|NCT00195494|E3|Reported Event|Year 1 E+M / Year 2 E|Following a blinded transition from year one-Etanercept two injections 25 mg weekly (given at the same time at different sites).
1223365|NCT00195494|E2|Reported Event|Year 1 M / Year 2 E+M|"Following a blinded transition from year one- Etanercept two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).~Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two."
1223366|NCT00195494|E1|Reported Event|Year 1 E+M / Year 2 E+M|"Following a blinded transition from year one- Etanercept injection- two injections 25 mg weekly (given at the same time at different sites)+ oral Methotrexate capsules weekly (same day as injection).~Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two."
1223367|NCT00195442|B1|Baseline|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
1223368|NCT00195442|P1|Participant Flow|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
1223369|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
1223370|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
1223371|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
1223846|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
1223373|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
1223374|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
1223375|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
1223376|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
1223377|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
1223378|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
1223379|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
1223380|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
1223381|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
1223382|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
1223383|NCT00195442|E1|Reported Event|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
1223384|NCT00195429|B3|Baseline|Total|Total of all reporting groups
1223385|NCT00195429|B2|Baseline|Sirolimus + Prednisone|
1223386|NCT00195429|B1|Baseline|Sirolimus + Tacrolimus|
1223387|NCT00195429|P2|Participant Flow|Sirolimus + Prednisone|
1223388|NCT00195429|P1|Participant Flow|Sirolimus + Tacrolimus|
1223389|NCT00195429|O2|Outcome|Sirolimus + Prednisone|
1223390|NCT00195429|O1|Outcome|Sirolimus + Tacrolimus|
1223391|NCT00195429|O2|Outcome|Sirolimus + Prednisone|
1223392|NCT00195429|O1|Outcome|Sirolimus + Tacrolimus|
1223393|NCT00195429|E2|Reported Event|Sirolimus + Prednisone|
1223394|NCT00195429|E1|Reported Event|Sirolimus + Tacrolimus|
1223395|NCT00195403|B1|Baseline|Etanercept|Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
1223396|NCT00195403|P1|Participant Flow|Etanercept|Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
1223397|NCT00195403|O1|Outcome|Etanercept|Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
1223398|NCT00195403|O1|Outcome|Etanercept|Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
1223399|NCT00195403|O1|Outcome|Etanercept|Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
1223400|NCT00195403|E1|Reported Event|Etanercept|Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
1223401|NCT00195351|B3|Baseline|Total|Total of all reporting groups
1223402|NCT00195351|B2|Baseline|Ceftriaxone Sodium + Metronidazole|Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.
1223403|NCT00195351|B1|Baseline|Tigecycline|Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
1223404|NCT00195351|P2|Participant Flow|Ceftriaxone Sodium + Metronidazole|Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.
1223405|NCT00195351|P1|Participant Flow|Tigecycline|Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
1223406|NCT00195351|O2|Outcome|Ceftriaxone Sodium + Metronidazole|Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.
1223407|NCT00195351|O1|Outcome|Tigecycline|Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
1223408|NCT00195351|O2|Outcome|Ceftriaxone Sodium + Metronidazole|Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.
1223409|NCT00195351|O1|Outcome|Tigecycline|Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
1223410|NCT00195351|O2|Outcome|Ceftriaxone Sodium + Metronidazole|Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.
1223411|NCT00195351|O1|Outcome|Tigecycline|Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
1223412|NCT00195351|E2|Reported Event|Ceftriaxone Sodium + Metronidazole|Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.
1223413|NCT00195351|E1|Reported Event|Tigecycline|Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
1224540|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
1223414|NCT00195338|B1|Baseline|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
1223415|NCT00195338|P1|Participant Flow|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
1223416|NCT00195338|O1|Outcome|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
1223417|NCT00195338|O1|Outcome|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
1223418|NCT00195338|O1|Outcome|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
1223419|NCT00195338|O1|Outcome|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
1223856|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
1223421|NCT00195338|E1|Reported Event|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
1223422|NCT00195273|B3|Baseline|Total|Total of all reporting groups
1223423|NCT00195273|B2|Baseline|Cyclosporine (CsA)|"Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
1223424|NCT00195273|B1|Baseline|Sirolimus|"Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
1223425|NCT00195273|P2|Participant Flow|Cyclosporine (CsA)|"Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
1223426|NCT00195273|P1|Participant Flow|Sirolimus|"Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
1223427|NCT00195273|O2|Outcome|Cyclosporine (CsA)|"Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
1223428|NCT00195273|O1|Outcome|Sirolimus|"Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
1223429|NCT00195273|O2|Outcome|Cyclosporine (CsA)|"Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
1223430|NCT00195273|O1|Outcome|Sirolimus|"Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
1223446|NCT00195260|P5|Participant Flow|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223431|NCT00195273|O2|Outcome|Cyclosporine (CsA)|"Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
1223432|NCT00195273|O1|Outcome|Sirolimus|"Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
1223433|NCT00195273|O2|Outcome|Cyclosporine (CsA)|"Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
1223434|NCT00195273|O1|Outcome|Sirolimus|"Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
1223435|NCT00195273|E2|Reported Event|Cyclosporine (CsA)|"Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
1223436|NCT00195273|E1|Reported Event|Sirolimus|"Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
1223437|NCT00195260|B3|Baseline|Total|Total of all reporting groups
1223438|NCT00195260|B2|Baseline|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223439|NCT00195260|B1|Baseline|Part 1|Participants received bosutinib capsule orally once daily continuously in 21-day cycles in dose escalation schemes of 50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, MTD-lead in (500 mg) until disease progression, unacceptable toxicity, or consent withdrawal.
1223440|NCT00195260|P11|Participant Flow|Non-small Cell Lung Cancer (NSCLC)|Participants with NSCLC received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223441|NCT00195260|P10|Participant Flow|Pancreatic Cancer|Participants with pancreatic cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223847|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
1223442|NCT00195260|P9|Participant Flow|Colorectal Cancer|Participants with colorectal cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223443|NCT00195260|P8|Participant Flow|Maximum Tolerated Dose (MTD) lead-in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223444|NCT00195260|P7|Participant Flow|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223445|NCT00195260|P6|Participant Flow|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223447|NCT00195260|P4|Participant Flow|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223448|NCT00195260|P3|Participant Flow|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223449|NCT00195260|P2|Participant Flow|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223450|NCT00195260|P1|Participant Flow|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223451|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223452|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223453|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223454|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223455|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223456|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223457|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223458|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223459|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223460|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223461|NCT00195260|O5|Outcome|Bosutinib 400 mg (Part 1 + Part 2)|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal in both Part 1 and Part 2 participants.
1223462|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223463|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223464|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223465|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223466|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223467|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223468|NCT00195260|O5|Outcome|Bosutinib 400 mg (Part 1 + Part 2)|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal in both Part 1 and Part 2 participants.
1223469|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223470|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223471|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223472|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223473|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223474|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223475|NCT00195260|O5|Outcome|Bosutinib 400 mg (Part 1 + Part 2)|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal in both Part 1 and Part 2 participants.
1223476|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223477|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223478|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223479|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223480|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223649|NCT00194610|P1|Participant Flow|Saline|Total 2 cc injected periurethrally
1223481|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223482|NCT00195260|O5|Outcome|Bosutinib 400 mg (Part 1 + Part 2)|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal in both Part 1 and Part 2 participants.
1223483|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223484|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223485|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223486|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223487|NCT00195260|O3|Outcome|Non-small Cell Lung Cancer (NSCLC)|Participants with NSCLC received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223488|NCT00195260|O2|Outcome|Pancreatic Cancer|Participants with pancreatic cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223489|NCT00195260|O1|Outcome|Colorectal Cancer|Participants with colorectal cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223490|NCT00195260|O3|Outcome|Non-small Cell Lung Cancer (NSCLC)|Participants with NSCLC received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223491|NCT00195260|O2|Outcome|Pancreatic Cancer|Participants with pancreatic cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223492|NCT00195260|O1|Outcome|Colorectal Cancer|Participants with colorectal cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223493|NCT00195260|O9|Outcome|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223494|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223495|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223496|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223497|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223498|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223499|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223500|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223501|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223502|NCT00195260|O9|Outcome|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223503|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223504|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223505|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223506|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223507|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223508|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223848|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
1223509|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223510|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223511|NCT00195260|O9|Outcome|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223512|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223851|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
1223513|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223514|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223515|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223516|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223517|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223518|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223519|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223520|NCT00195260|O9|Outcome|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223521|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223522|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223523|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223524|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223525|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223526|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223527|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223528|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223529|NCT00195260|O9|Outcome|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223530|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223531|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223532|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223533|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223534|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223535|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223536|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223537|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223538|NCT00195260|O9|Outcome|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223539|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223540|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223541|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223542|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1231179|NCT00150618|O3|Outcome|SPD503 (3 mg)|Guanfacine HCl once daily
1223543|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223544|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223545|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223546|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223547|NCT00195260|O1|Outcome|All Participant|All participants who received bosutinib capsule (50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, MTD-lead in) orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223548|NCT00195260|O1|Outcome|All Participant|All participants who received bosutinib capsule (50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, MTD-lead in) orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223549|NCT00195260|O3|Outcome|Non-small Cell Lung Cancer (NSCLC)|Participants with NSCLC received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223550|NCT00195260|O2|Outcome|Pancreatic Cancer|Participants with pancreatic cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223551|NCT00195260|O1|Outcome|Colorectal Cancer|Participants with colorectal cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223552|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223553|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223554|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223555|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223556|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223557|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223558|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223559|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223560|NCT00195260|O9|Outcome|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223561|NCT00195260|O8|Outcome|MTD lead-in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223562|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223563|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223564|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223565|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223566|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223567|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223568|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223569|NCT00195260|O9|Outcome|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223570|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223571|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223572|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223573|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223574|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223575|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223849|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
1223576|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223577|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223578|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223579|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223580|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223581|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223582|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223583|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223584|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223585|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223586|NCT00195260|E9|Reported Event|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223587|NCT00195260|E8|Reported Event|MTD lead-in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223588|NCT00195260|E7|Reported Event|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223589|NCT00195260|E6|Reported Event|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223590|NCT00195260|E5|Reported Event|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223591|NCT00195260|E4|Reported Event|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223592|NCT00195260|E3|Reported Event|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223593|NCT00195260|E2|Reported Event|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223594|NCT00195260|E1|Reported Event|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
1223595|NCT00194896|B5|Baseline|Total|Total of all reporting groups
1223596|NCT00194896|B4|Baseline|Glyburide Autoantibody Negative|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
1223597|NCT00194896|B3|Baseline|Glyburide Autoantibody Positive|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), islet cell autoantibodies 512 (IA2).
1223598|NCT00194896|B2|Baseline|Rosiglitazone Autoantibody Negative|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
1223599|NCT00194896|B1|Baseline|Rosiglitazone Autoantibody Positive|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD),and/or islet cell autoantibodies 512 (IA2).
1223600|NCT00194896|P4|Participant Flow|Glyburide Autoantibody Negative|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
1223614|NCT00194896|E2|Reported Event|Rosiglitazone Autoantibody Negative|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
1231180|NCT00150618|O2|Outcome|SPD503 (2 mg)|Guanfacine HCl once daily
1223601|NCT00194896|P3|Participant Flow|Glyburide Autoantibody Positive|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), islet cell autoantibodies 512 (IA2).
1223852|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
1241313|NCT00117338|E1|Reported Event|Montelukast Intravenous (IV) 5.25 mg|
1223602|NCT00194896|P2|Participant Flow|Rosiglitazone Autoantibody Negative|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
1223603|NCT00194896|P1|Participant Flow|Rosiglitazone Autoantibody Positive|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD),and/or islet cell autoantibodies 512 (IA2).
1223604|NCT00194896|O4|Outcome|Glyburide Autoantibody Negative|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
1223605|NCT00194896|O3|Outcome|Glyburide Autoantibody Positive|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), islet cell autoantibodies 512 (IA2).
1223606|NCT00194896|O2|Outcome|Rosiglitazone Autoantibody Negative|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
1223607|NCT00194896|O1|Outcome|Rosiglitazone Autoantibody Positive|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD),and/or islet cell autoantibodies 512 (IA2).
1223608|NCT00194896|O4|Outcome|Glyburide Autoantibody Negative|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
1223609|NCT00194896|O3|Outcome|Glyburide Autoantibody Positive|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), islet cell autoantibodies 512 (IA2).
1223610|NCT00194896|O2|Outcome|Rosiglitazone Autoantibody Negative|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
1223611|NCT00194896|O1|Outcome|Rosiglitazone Autoantibody Positive|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD),and/or islet cell autoantibodies 512 (IA2).
1223612|NCT00194896|E4|Reported Event|Glyburide Autoantibody Negative|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
1223613|NCT00194896|E3|Reported Event|Glyburide Autoantibody Positive|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), islet cell autoantibodies 512 (IA2).
1223644|NCT00194675|E1|Reported Event|Testosterone Gel + Oral Placebo|Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
1223645|NCT00194610|B3|Baseline|Total|Total of all reporting groups
1231181|NCT00150618|O1|Outcome|SPD503 (1 mg)|Guanfacine HCl once daily
1223615|NCT00194896|E1|Reported Event|Rosiglitazone Autoantibody Positive|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD),and/or islet cell autoantibodies 512 (IA2).
1223616|NCT00194792|B1|Baseline|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description~exemestane: Given PO~triptorelin pamoate: Given IM~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~paclitaxel: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
1223617|NCT00194792|P1|Participant Flow|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description~exemestane: Given PO~triptorelin pamoate: Given IM~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~paclitaxel: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
1223618|NCT00194792|O1|Outcome|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description~exemestane: Given PO~triptorelin pamoate: Given IM~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~paclitaxel: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
1223619|NCT00194792|O1|Outcome|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description~exemestane: Given PO~triptorelin pamoate: Given IM~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~paclitaxel: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
1223620|NCT00194792|O1|Outcome|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description~exemestane: Given PO~triptorelin pamoate: Given IM~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~paclitaxel: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
1223621|NCT00194792|O1|Outcome|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description~exemestane: Given PO~triptorelin pamoate: Given IM~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~paclitaxel: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
1223622|NCT00194792|O1|Outcome|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description~exemestane: Given PO~triptorelin pamoate: Given IM~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~paclitaxel: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
1223623|NCT00194792|O1|Outcome|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description~exemestane: Given PO~triptorelin pamoate: Given IM~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~paclitaxel: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
1223624|NCT00194792|O1|Outcome|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description~exemestane: Given PO~triptorelin pamoate: Given IM~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~paclitaxel: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
1223625|NCT00194792|E1|Reported Event|Treatment (Hormone Therapy and Chemotherapy)|"See detailed description~exemestane: Given PO~triptorelin pamoate: Given IM~capecitabine: Given PO~methotrexate: Given IV~vinorelbine tartrate: Given IV~paclitaxel: Given IV~therapeutic conventional surgery: Undergo lumpectomy or mastectomy~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
1223626|NCT00194675|B3|Baseline|Total|Total of all reporting groups
1223627|NCT00194675|B2|Baseline|Testosterone Gel + Oral Dutasteride|Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
1223628|NCT00194675|B1|Baseline|Testosterone Gel + Oral Placebo|Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
1223629|NCT00194675|P2|Participant Flow|Testosterone Gel + Oral Dutasteride|Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
1223630|NCT00194675|P1|Participant Flow|Testosterone Gel + Oral Placebo|Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
1223631|NCT00194675|O2|Outcome|Testosterone Gel + Oral Dutasteride|Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
1223632|NCT00194675|O1|Outcome|Testosterone Gel + Oral Placebo|Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
1223633|NCT00194675|O2|Outcome|Testosterone Gel + Oral Dutasteride|Testosterone 1% gel 7.5 daily + dutasteride 0.5 mg po daily
1223634|NCT00194675|O1|Outcome|Testosterone Gel + Oral Placebo|Testosterone 1% gel 7.5 daily + oral placebo dutasteride daily
1223635|NCT00194675|O2|Outcome|Testosterone Gel + Oral Dutasteride|Testosterone 1% gel 7.5 daily + dutasteride 0.5 mg po daily
1223636|NCT00194675|O1|Outcome|Testosterone Gel + Oral Placebo|Testosterone 1% gel 7.5 daily + oral placebo dutasteride daily
1223637|NCT00194675|O2|Outcome|Testosterone Gel + Oral Dutasteride|Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
1223638|NCT00194675|O1|Outcome|Testosterone Gel + Oral Placebo|Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
1223639|NCT00194675|O2|Outcome|Testosterone Gel + Oral Dutasteride|Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
1223640|NCT00194675|O1|Outcome|Testosterone Gel + Oral Placebo|Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
1223641|NCT00194675|O2|Outcome|Testosterone Gel + Oral Dutasteride|Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
1223642|NCT00194675|O1|Outcome|Testosterone Gel + Oral Placebo|Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
1223643|NCT00194675|E2|Reported Event|Testosterone Gel + Oral Dutasteride|Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
1223646|NCT00194610|B2|Baseline|Botox|Botox 25 IU injected bilaterally periurethrally for a total of 50 IU. Possible but not mandatory was two more injections of 25 IU in each of two trigger points
1223647|NCT00194610|B1|Baseline|Saline|Total 2 cc injected periurethrally
1223648|NCT00194610|P2|Participant Flow|Botox|Botox 25 IU injected bilaterally periurethrally for a total of 50 IU. Possible but not mandatory was two more injections of 25 IU in each of two trigger points
1223650|NCT00194610|O2|Outcome|Experimental Intervention: Botox|Botulinum toxin 25 IU injected bilaterally periurethrally for a total of 50 IU. Possible, but not mandatory, injections of 25 IU in each of 2 trigger points.
1223651|NCT00194610|O1|Outcome|Placebo : Saline|Saline 2 cc total injected periurethrally
1223652|NCT00194610|E2|Reported Event|Botox|Botox 25 IU injected bilaterally periurethrally for a total of 50 IU. Possible but not mandatory was two more injections of 25 IU in each of two trigger points
1223653|NCT00194610|E1|Reported Event|Saline|Total 2 cc injected periurethrally
1223654|NCT00194532|B3|Baseline|Total|Total of all reporting groups
1223655|NCT00194532|B2|Baseline|Cefpodoxime|Cefpodoxime 100 mg BID X 3 days
1223656|NCT00194532|B1|Baseline|Ciprofloxacin|Ciprofloxacin 250 mg BID X 3 days
1223657|NCT00194532|P2|Participant Flow|Cefpodoxime|Cefpodoxime 100 mg BID X 3 days
1223658|NCT00194532|P1|Participant Flow|Ciprofloxacin|Ciprofloxacin 250 mg BID X 3 days
1223659|NCT00194532|O2|Outcome|Cefpodoxime|Cefpodoxime 100 mg BID X 3 days
1223660|NCT00194532|O1|Outcome|Ciprofloxacin|Ciprofloxacin 250 mg BID X 3 days
1223661|NCT00194532|O2|Outcome|Cefpodoxime|Cefpodoxime 100 mg BID X 3 days
1223662|NCT00194532|O1|Outcome|Ciprofloxacin|Ciprofloxacin 250 mg BID X 3 days
1223663|NCT00194532|E2|Reported Event|Cefpodoxime|Cefpodoxime 100 mg BID X 3 days
1223664|NCT00194532|E1|Reported Event|Ciprofloxacin|Ciprofloxacin 250 mg BID X 3 days
1223665|NCT00194129|B3|Baseline|Total|Total of all reporting groups
1223666|NCT00194129|B2|Baseline|Lithium Plus Placebo|
1223667|NCT00194129|B1|Baseline|Lithium Plus Divalproex|
1223668|NCT00194129|P2|Participant Flow|Lithium Plus Placebo|
1223669|NCT00194129|P1|Participant Flow|Lithium Plus Divalproex|
1223670|NCT00194129|O2|Outcome|Lithium Plus Placebo|
1223671|NCT00194129|O1|Outcome|Lithium Plus Divalproex|
1223672|NCT00194129|E2|Reported Event|Lithium Plus Placebo|
1223673|NCT00194129|E1|Reported Event|Lithium Plus Divalproex|
1223674|NCT00194077|B3|Baseline|Total|Total of all reporting groups
1223675|NCT00194077|B2|Baseline|Placebo|Placebo (Children with Symptoms of Mania Study)
1223676|NCT00194077|B1|Baseline|Aripiprazole|Abilify (Children with Symptoms of Mania Study)
1223677|NCT00194077|P2|Participant Flow|Placebo|Randomized assignment to placebo
1223678|NCT00194077|P1|Participant Flow|Aripiprazole|Random assignment with titrated dosing
1223679|NCT00194077|O2|Outcome|Placebo|Placebo dosing to mirror active treatment
1223680|NCT00194077|O1|Outcome|Aripiprazole|Aripiprazole dosing dependent upon response
1223681|NCT00194077|E2|Reported Event|Placebo|Placebo (Children With Symptoms of Mania Study)
1223682|NCT00194077|E1|Reported Event|Aripiprazole|Abilify (Children With Symptoms of Mania Study)
1223683|NCT00194025|B1|Baseline|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
1223684|NCT00194025|P1|Participant Flow|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
1223685|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
1223686|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
1223687|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
1223688|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
1223842|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
1223850|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
1223689|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
1223690|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
1223691|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
1223692|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
1223693|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
1223694|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
1223695|NCT00194025|E1|Reported Event|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
1223696|NCT00194012|B3|Baseline|Total|Total of all reporting groups
1223697|NCT00194012|B2|Baseline|Placebo Randomized Phase|abilify (aripiprazole) : dosing is 2mg, 5mg, 7mg, 10mg, 12mg or 15 mg depending on response and during the double blind arms may be randomized to placebo
1223698|NCT00194012|B1|Baseline|Abilify Randomized Phase|abilify (aripiprazole) : dosing is 2mg, 5mg, 7mg, 10mg, 12mg or 15 mg depending on response and during the double blind arms may be randomized to placebo
1223699|NCT00194012|P2|Participant Flow|Placebo|abilify (aripiprazole) : dosing is 2mg, 5mg, 7mg, 10mg, 12mg or 15 mg depending on response and during the double blind arms may be randomized to placebo
1223700|NCT00194012|P1|Participant Flow|Aripiprazle|abilify (aripiprazole) : dosing is 2mg, 5mg, 7mg, 10mg, 12mg or 15 mg depending on response and during the double blind arms may be randomized to placebo
1223701|NCT00194012|O2|Outcome|Placebo Randomized Phase|abilify (aripiprazole) : dosing is 2mg, 5mg, 7mg, 10mg, 12mg or 15 mg depending on response and during the double blind arms may be randomized to placebo
1223702|NCT00194012|O1|Outcome|Abilify Randomized Phase|abilify (aripiprazole) : dosing is 2mg, 5mg, 7mg, 10mg, 12mg or 15 mg depending on response and during the double blind arms may be randomized to placebo
1223703|NCT00194012|E4|Reported Event|Open Label Extension Phase|Previously randomized to placebo
1223704|NCT00194012|E3|Reported Event|Abilify Open Label Extension|Previously randomized to abilify
1223705|NCT00194012|E2|Reported Event|Placebo Randomized Phase|abilify (aripiprazole) : dosing is 2mg, 5mg, 7mg, 10mg, 12mg or 15 mg depending on response and during the double blind arms may be randomized to placebo
1223706|NCT00194012|E1|Reported Event|Abilify Randomized Phase|abilify (aripiprazole) : dosing is 2mg, 5mg, 7mg, 10mg, 12mg or 15 mg depending on response and during the double blind arms may be randomized to placebo
1223707|NCT00193609|B1|Baseline|Intervention|All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.
1223708|NCT00193609|P1|Participant Flow|Oxaliplatin/Capecitabine|All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.
1223709|NCT00193609|O1|Outcome|Intervention|All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.
1223710|NCT00193609|O1|Outcome|Intervention|All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.
1223711|NCT00193609|E1|Reported Event|Intervention|All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.
1223712|NCT00193596|B3|Baseline|Total|Total of all reporting groups
1223713|NCT00193596|B2|Baseline|Irinotecan/Gemcitabine/Gefitinib|"Irinotecan 100 mg/m2 IV, days 1 and 8~Gemcitabine 1000 mg/m2 IV, days 1 and 8~Regimen B was repeated at a 21-day interval"
1223714|NCT00193596|B1|Baseline|Paclitaxel/Carboplatin/Etoposide/Gefitinib|"Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1~Carboplatin area under the curve (AUC) 6.0 IV, day 1~Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10~Regimen A was repeated at a 21-day interval"
1223715|NCT00193596|P2|Participant Flow|Irinotecan/Gemcitabine/Gefitinib|"Irinotecan 100 mg/m2 IV, days 1 and 8~Gemcitabine 1000 mg/m2 IV, days 1 and 8~Regimen B was repeated at a 21-day interval"
1223716|NCT00193596|P1|Participant Flow|Paclitaxel/Carboplatin/Etoposide/Gefitinib|"Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1~Carboplatin area under the curve (AUC) 6.0 IV, day 1~Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10~Regimen A was repeated at a 21-day interval"
1223717|NCT00193596|O2|Outcome|Irinotecan/Gemcitabine/Gefitinib|"Irinotecan 100 mg/m2 IV, days 1 and 8~Gemcitabine 1000 mg/m2 IV, days 1 and 8~Regimen B was repeated at a 21-day interval"
1223718|NCT00193596|O1|Outcome|Paclitaxel/Carboplatin/Etoposide/Gefitinib|"Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1~Carboplatin area under the curve (AUC) 6.0 IV, day 1~Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10~Regimen A was repeated at a 21-day interval"
1223719|NCT00193596|O2|Outcome|Irinotecan/Gemcitabine/Gefitinib|"Irinotecan 100 mg/m2 IV, days 1 and 8~Gemcitabine 1000 mg/m2 IV, days 1 and 8~Regimen B was repeated at a 21-day interval"
1223720|NCT00193596|O1|Outcome|Paclitaxel/Carboplatin/Etoposide/Gefitinib|"Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1~Carboplatin area under the curve (AUC) 6.0 IV, day 1~Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10~Regimen A was repeated at a 21-day interval"
1223721|NCT00193596|E2|Reported Event|Irinotecan/Gemcitabine/Gefitinib|"Irinotecan 100 mg/m2 IV, days 1 and 8~Gemcitabine 1000 mg/m2 IV, days 1 and 8~Regimen B was repeated at a 21-day interval"
1223722|NCT00193596|E1|Reported Event|Paclitaxel/Carboplatin/Etoposide/Gefitinib|"Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1~Carboplatin area under the curve (AUC) 6.0 IV, day 1~Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10~Regimen A was repeated at a 21-day interval"
1223723|NCT00193492|B3|Baseline|Total|Total of all reporting groups
1223724|NCT00193492|B2|Baseline|Rituximab/Bevacizumab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). During the 4-week course of rituximab, all patients will receive 2 doses of bevacizumab 10mg/kg IV, given on Days 3 and 15. The first dose will be given on Day 3, following rituximab on Day 1. If both drugs are well tolerated during the first dose, rituximab and bevacizumab should be given on the same day for the Day 15 dose and all subsequent doses.~Bevacizumab~Rituximab"
1223725|NCT00193492|B1|Baseline|Rituximab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). Patients who have objective response or stable disease at week 12 reevaluation will receive 4 additional doses of rituximab (375 mg/m2) administered in months 3 (week 12), 5, 7, and 9.~Rituximab"
1223726|NCT00193492|P2|Participant Flow|Rituximab/Bevacizumab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). During the 4-week course of rituximab, all patients will receive 2 doses of bevacizumab 10mg/kg IV, given on Days 3 and 15. The first dose will be given on Day 3, following rituximab on Day 1. If both drugs are well tolerated during the first dose, rituximab and bevacizumab should be given on the same day for the Day 15 dose and all subsequent doses.~Bevacizumab~Rituximab"
1223727|NCT00193492|P1|Participant Flow|Rituximab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). Patients who have objective response or stable disease at week 12 reevaluation will receive 4 additional doses of rituximab (375 mg/m2) administered in months 3 (week 12), 5, 7, and 9.~Rituximab"
1223728|NCT00193492|O2|Outcome|Rituximab/Bevacizumab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). During the 4-week course of rituximab, all patients will receive 2 doses of bevacizumab 10mg/kg IV, given on Days 3 and 15. The first dose will be given on Day 3, following rituximab on Day 1. If both drugs are well tolerated during the first dose, rituximab and bevacizumab should be given on the same day for the Day 15 dose and all subsequent doses.~Bevacizumab~Rituximab"
1223729|NCT00193492|O1|Outcome|Rituximab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). Patients who have objective response or stable disease at week 12 reevaluation will receive 4 additional doses of rituximab (375 mg/m2) administered in months 3 (week 12), 5, 7, and 9.~Rituximab"
1223730|NCT00193492|O2|Outcome|Rituximab/Bevacizumab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). During the 4-week course of rituximab, all patients will receive 2 doses of bevacizumab 10mg/kg IV, given on Days 3 and 15. The first dose will be given on Day 3, following rituximab on Day 1. If both drugs are well tolerated during the first dose, rituximab and bevacizumab should be given on the same day for the Day 15 dose and all subsequent doses.~Bevacizumab~Rituximab"
1223731|NCT00193492|O1|Outcome|Rituximab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). Patients who have objective response or stable disease at week 12 reevaluation will receive 4 additional doses of rituximab (375 mg/m2) administered in months 3 (week 12), 5, 7, and 9.~Rituximab"
1223732|NCT00193492|E2|Reported Event|Rituximab/Bevacizumab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). During the 4-week course of rituximab, all patients will receive 2 doses of bevacizumab 10mg/kg IV, given on Days 3 and 15. The first dose will be given on Day 3, following rituximab on Day 1. If both drugs are well tolerated during the first dose, rituximab and bevacizumab should be given on the same day for the Day 15 dose and all subsequent doses.~Bevacizumab~Rituximab"
1223733|NCT00193492|E1|Reported Event|Rituximab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). Patients who have objective response or stable disease at week 12 reevaluation will receive 4 additional doses of rituximab (375 mg/m2) administered in months 3 (week 12), 5, 7, and 9.~Rituximab"
1223734|NCT00193479|B1|Baseline|CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab|Cyclophosphamide 500mg/m2 IV day 1; Mitoxantrone 10mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2 OR Cyclophosphamide 500mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2
1224837|NCT00187200|B2|Baseline|Sequential VV Pacing|V-V delay was optimized
1223735|NCT00193479|P1|Participant Flow|CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab|Cyclophosphamide 500mg/m2 IV day 1; Mitoxantrone 10mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2 OR Cyclophosphamide 500mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2
1241314|NCT00117312|B5|Baseline|Total|Total of all reporting groups
1223736|NCT00193479|O1|Outcome|CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab|Cyclophosphamide 500mg/m2 IV day 1; Mitoxantrone 10mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2 OR Cyclophosphamide 500mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2
1223737|NCT00193479|E1|Reported Event|CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab|Cyclophosphamide 500mg/m2 IV day 1; Mitoxantrone 10mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2 OR Cyclophosphamide 500mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2
1223738|NCT00193453|B1|Baseline|Intervention|Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
1223739|NCT00193453|P1|Participant Flow|Intervention|Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
1223740|NCT00193453|O1|Outcome|Intervention|Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
1223741|NCT00193453|O1|Outcome|Intervention|Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
1223742|NCT00193453|O1|Outcome|Intervention|Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
1223743|NCT00193453|E1|Reported Event|Intervention|Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
1223744|NCT00193427|B1|Baseline|Intervention|Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
1223745|NCT00193427|P1|Participant Flow|Intervention|Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
1223746|NCT00193427|O1|Outcome|Intervention|Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
1223747|NCT00193427|O1|Outcome|Intervention|Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
1223748|NCT00193427|O1|Outcome|Intervention|Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered.
1223749|NCT00193427|O1|Outcome|Intervention|Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
1223750|NCT00193427|E1|Reported Event|Intervention|Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
1223751|NCT00193414|B1|Baseline|Intervention|Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
1223752|NCT00193414|P1|Participant Flow|Intervention|Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
1223753|NCT00193414|O1|Outcome|Intervention|Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
1223754|NCT00193414|O1|Outcome|Intervention|Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
1224989|NCT00186888|O3|Outcome|1 Year|Participant age was 1 year ±3 months.
1223755|NCT00193414|O1|Outcome|Intervention|Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
1223853|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
1223756|NCT00193414|E1|Reported Event|Intervention|Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
1223757|NCT00193375|B1|Baseline|Intervention|Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
1223758|NCT00193375|P1|Participant Flow|Intervention|Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
1223759|NCT00193375|O1|Outcome|Intervention|Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
1223760|NCT00193375|O1|Outcome|Intervention|Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
1223761|NCT00193375|O1|Outcome|Intervention|Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
1223762|NCT00193375|E1|Reported Event|Intervention|Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
1223763|NCT00193258|B1|Baseline|Bevacizumab/Erlotinib/Imatinib|In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
1223764|NCT00193258|P1|Participant Flow|Bevacizumab/Erlotinib/Imatinib|In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
1223765|NCT00193258|O1|Outcome|Bevacizumab/Erlotinib/Imatinib|In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
1223766|NCT00193258|O1|Outcome|Bevacizumab/Erlotinib/Imatinib|In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
1223767|NCT00193258|O1|Outcome|Bevacizumab/Erlotinib/Imatinib|In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
1223768|NCT00193258|E1|Reported Event|Bevacizumab/Erlotinib/Imatinib|In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
1223769|NCT00193219|B1|Baseline|Bevacizumab/Cetuximab/FOLFOX|Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
1223770|NCT00193219|P1|Participant Flow|Bevacizumab/Cetuximab/FOLFOX|Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
1223771|NCT00193219|O1|Outcome|Bevacizumab/Cetuximab/FOLFOX|Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
1223772|NCT00193219|O1|Outcome|Bevacizumab/Cetuximab/FOLFOX|Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
1223854|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
1223855|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
1241326|NCT00117312|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
1223773|NCT00193219|O1|Outcome|Bevacizumab/Cetuximab/FOLFOX|Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
1223774|NCT00193219|E1|Reported Event|Bevacizumab/Cetuximab/FOLFOX|Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
1223775|NCT00193206|B1|Baseline|Intervention|"Systemic Therapy~ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles~Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles~Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles"
1223776|NCT00193206|P1|Participant Flow|Intervention|"Systemic Therapy~ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles~Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles~Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles"
1223777|NCT00193206|O1|Outcome|Intervention|"Systemic Therapy~ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles~Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles~Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles"
1223778|NCT00193206|E1|Reported Event|Intervention|"Systemic Therapy~ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles~Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles~Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles"
1223779|NCT00193180|B1|Baseline|Intervention|All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.
1223780|NCT00193180|P1|Participant Flow|Intervention|All patients in this study received docetaxel 30 mg/m^2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.
1223781|NCT00193180|O1|Outcome|Intervention|All patients in this study received docetaxel 30 mg/m^2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.
1223782|NCT00193180|O1|Outcome|Intervention|All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.
1223783|NCT00193180|O1|Outcome|Intervention|All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.
1223784|NCT00193180|E1|Reported Event|Docetaxel+Imatinib|Patients received docetaxel 30mg/m2 IV weekly on days 1, 8, and 15 of each 28 day cycle. Patients received oral imatinib 400mg daily. Fifteen patients initially received oral imatinib 600mg daily but had their dose reduced to 400mg daily when they were unable to tolerate the higher dose.
1223785|NCT00193128|B3|Baseline|Total|Total of all reporting groups
1223786|NCT00193128|B2|Baseline|Oxaliplatin/Docetaxel/Capecitabine/Radiation|"After completion of the first phase of the trial, the second cohort began treatment.~Oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).~Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved."
1223787|NCT00193128|B1|Baseline|Oxaliplatin/Docetaxel/Radiation|"An initial cohort of 10 patients was treated with oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).~Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved."
1223788|NCT00193128|P2|Participant Flow|Oxaliplatin/Docetaxel/Capecitabine/Radiation|"After completion of the first phase of the trial, the second cohort began treatment.~Oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).~Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved."
1223789|NCT00193128|P1|Participant Flow|Oxaliplatin/Docetaxel/Radiation|"An initial cohort of 10 patients was treated with oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).~Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved."
1223843|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
1223844|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
1231182|NCT00150618|O5|Outcome|Placebo|once daily
1223790|NCT00193128|O2|Outcome|Oxaliplatin/Docetaxel/Capecitabine/Radiation|"After completion of the first phase of the trial, the second cohort began treatment.~Oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).~Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved."
1223791|NCT00193128|O1|Outcome|Oxaliplatin/Docetaxel/Radiation|"An initial cohort of 10 patients was treated with oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).~Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved."
1223792|NCT00193128|E2|Reported Event|Oxaliplatin/Docetaxel/Capecitabine/Radiation|"After completion of the first phase of the trial, the second cohort began treatment.~Oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).~Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved."
1223793|NCT00193128|E1|Reported Event|Oxaliplatin/Docetaxel/Radiation|"An initial cohort of 10 patients was treated with oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).~Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved."
1223794|NCT00193063|B1|Baseline|Gemcitabine/Trastuzumab|All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
1223795|NCT00193063|P1|Participant Flow|Gemcitabine/Trastuzumab|All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
1223796|NCT00193063|O1|Outcome|Gemcitabine/Trastuzumab|All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
1223797|NCT00193063|O1|Outcome|Gemcitabine/Trastuzumab|All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
1223798|NCT00193063|O1|Outcome|Gemcitabine/Trastuzumab|All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
1223799|NCT00193063|E1|Reported Event|Intervention|All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
1223800|NCT00193050|B1|Baseline|Intervention|"In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles~Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.~After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.~After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines."
1223801|NCT00193050|P1|Participant Flow|Intervention|"In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles~Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.~After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.~After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines."
1223802|NCT00193050|O1|Outcome|Intervention|"In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles~Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.~After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.~After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines."
1223803|NCT00193050|E1|Reported Event|Intervention|"In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles~Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.~After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.~After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines."
1223804|NCT00193037|B3|Baseline|Total|Total of all reporting groups
1223845|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
1223805|NCT00193037|B2|Baseline|Arm B - Docetaxel Then Liposomal Doxorubicin|"Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.~Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided the patient still met the eligibility laboratory and performance status criteria."
1223806|NCT00193037|B1|Baseline|Arm A -Liposomal Doxorubicin Then Docetaxel|"Liposomal doxorubicin (Arm A)~Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.~Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided the patient still met the eligibility laboratory and performance status criteria."
1223807|NCT00193037|P2|Participant Flow|Arm B - Docetaxel Then Liposomal Doxorubicin|"Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.~Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided patient still met the eligibility laboratory and performance status criteria."
1223808|NCT00193037|P1|Participant Flow|Arm A -Liposomal Doxorubicin Then Docetaxel|"Liposomal doxorubicin (Arm A)~Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.~Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided patient still met the eligibility laboratory and performance status criteria."
1223809|NCT00193037|O2|Outcome|Arm B - Docetaxel Then Liposomal Doxorubicin|"Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.~Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided the patient still met the eligibility laboratory and performance status criteria."
1223810|NCT00193037|O1|Outcome|Arm A -Liposomal Doxorubicin Then Docetaxel|"Liposomal doxorubicin (Arm A)~Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.~Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided the patient still met the eligibility laboratory and performance status criteria."
1223811|NCT00193037|O2|Outcome|Arm B - Docetaxel Then Liposomal Doxorubicin|"Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.~Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided the patient still met the eligibility laboratory and performance status criteria."
1223812|NCT00193037|O1|Outcome|Arm A -Liposomal Doxorubicin Then Docetaxel|"Liposomal doxorubicin (Arm A)~Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.~Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided the patient still met the eligibility laboratory and performance status criteria."
1223813|NCT00193037|E2|Reported Event|Arm B - Docetaxel Then Liposomal Doxorubicin|Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8, and 15 followed by one week rest, administered on an every 28 day cycle. This dosing schedule will define one cycle. Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided patient still met the eligibility laboratory and performance status criteria.
1223814|NCT00193037|E1|Reported Event|Arm A - Liposomal Doxorubicin Then Docetaxel|Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q28 days thru peripheral vein or central venous access. This will define one cycle. Patients demonstrating progression on Liposomal Doxorubicin were eligible for crossover to treatment on Docetaxel, provided patient still met the eligibility lab and performance status criteria.
1223815|NCT00192296|B5|Baseline|Total|Total of all reporting groups
1223816|NCT00192296|B4|Baseline|MEDI-528 9 mg|
1223817|NCT00192296|B3|Baseline|MEDI-528 3 mg|
1223818|NCT00192296|B2|Baseline|MEDI-528 1 mg|
1223819|NCT00192296|B1|Baseline|MEDI-528 0.3 mg|
1223820|NCT00192296|P4|Participant Flow|MEDI-528 9 mg|
1223821|NCT00192296|P3|Participant Flow|MEDI-528 3 mg|
1223822|NCT00192296|P2|Participant Flow|MEDI-528 1 mg|
1223823|NCT00192296|P1|Participant Flow|MEDI-528 0.3 mg|
1223824|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
1223825|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
1223826|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
1223827|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
1223828|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
1223829|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
1223830|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
1223831|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
1223832|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
1223833|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
1223834|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
1223835|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
1223836|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
1223837|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
1223838|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
1223839|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
1223840|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
1223841|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
1231183|NCT00150618|O4|Outcome|SPD503 (4 mg)|Guanfacine HCl once daily
1223857|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
1223858|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
1223859|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
1223860|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
1223861|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
1223862|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
1223863|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
1223864|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
1223865|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
1223866|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
1223867|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
1223868|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
1223869|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
1223870|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
1223871|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
1223872|NCT00192296|E4|Reported Event|MEDI-528 9 mg|
1223873|NCT00192296|E3|Reported Event|MEDI-528 3 mg|
1223874|NCT00192296|E2|Reported Event|MEDI-528 1 mg|
1223875|NCT00192296|E1|Reported Event|MEDI-528 0.3 mg|
1223876|NCT00192647|B3|Baseline|Total|Total of all reporting groups
1223877|NCT00192647|B2|Baseline|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
1223878|NCT00192647|B1|Baseline|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
1223879|NCT00192647|P2|Participant Flow|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
1223880|NCT00192647|P1|Participant Flow|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with peginterferon (PEG-IFN) alfa-2a (Pegasys), 360 micrograms (mcg) subcutaneous (SC) once weekly, along with ribavirin, 1000 or 1200 milligrams (mg) orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
1223881|NCT00192647|O2|Outcome|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
1223882|NCT00192647|O1|Outcome|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
1223883|NCT00192647|O2|Outcome|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
1223884|NCT00192647|O1|Outcome|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
1223885|NCT00192647|O2|Outcome|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
1223886|NCT00192647|O1|Outcome|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
1223887|NCT00192647|O2|Outcome|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
1223922|NCT00192075|E1|Reported Event|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
1224165|NCT00191477|O2|Outcome|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
1223888|NCT00192647|O1|Outcome|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
1223889|NCT00192647|O2|Outcome|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
1223890|NCT00192647|O1|Outcome|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
1223891|NCT00192647|O2|Outcome|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
1223892|NCT00192647|O1|Outcome|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
1223893|NCT00192647|E2|Reported Event|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
1223894|NCT00192647|E1|Reported Event|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
1223895|NCT00192075|B3|Baseline|Total|Total of all reporting groups
1223896|NCT00192075|B2|Baseline|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
1223897|NCT00192075|B1|Baseline|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
1223898|NCT00192075|P2|Participant Flow|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
1223899|NCT00192075|P1|Participant Flow|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
1223900|NCT00192075|O1|Outcome|A + FOLFOX 4 - Avastin Subgroup|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
1223901|NCT00192075|O2|Outcome|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
1223902|NCT00192075|O1|Outcome|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
1223903|NCT00192075|O2|Outcome|A + FOLFOX 4 - Avastin Subgroup|Patients who received Avastin plus oxaliplatin plus 5FU/Folinic Acid
1223904|NCT00192075|O1|Outcome|A+FFG - Avastin Subgrouup|Patients who received Avastin plus gemcitabine plus 5FU/Folinic Acid
1223905|NCT00192075|O2|Outcome|A + FOLFOX 4 - Avastin Subgroup|Patients who received Avastin plus oxaliplatin plus 5FU/Folinic Acid
1223906|NCT00192075|O1|Outcome|A+FFG - Avastin Subgroup|Patients who received Avastin plus gemcitabine plus 5FU/Folinic Acid
1223907|NCT00192075|O2|Outcome|A + FOLFOX 4 - Avastin Subgroup|Patients who received Avastin plus oxaliplatin plus 5FU/Folinic Acid
1223908|NCT00192075|O1|Outcome|A+FFG - Avastin Subgroup|Patients who received Avastin plus gemcitabine plus 5FU/Folinic Acid
1223909|NCT00192075|O2|Outcome|A + FOLFOX 4 - Avastin Subgroup|Includes patients who received Avastin plus oxaliplatin plus 5FU/Folinic Acid
1223910|NCT00192075|O1|Outcome|A+FFG - Avastin Subgroup|Patients who received Avastin plus gemcitabine plus 5FU/Folinic Acid
1223911|NCT00192075|O2|Outcome|A + FOLFOX 4 - Avastin Subgroup|Patients who received Avastin plus oxaliplatin plus 5FU/Folinic Acid
1223912|NCT00192075|O1|Outcome|A+FFG - Avastin Subgroup|Patients who received Avastin plus gemcitabine plus 5FU/Folinic Acid
1223913|NCT00192075|O2|Outcome|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
1223914|NCT00192075|O1|Outcome|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
1223915|NCT00192075|O2|Outcome|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
1223916|NCT00192075|O1|Outcome|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
1223917|NCT00192075|O2|Outcome|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
1223918|NCT00192075|O1|Outcome|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
1223919|NCT00192075|O2|Outcome|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
1223920|NCT00192075|O1|Outcome|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
1223921|NCT00192075|E2|Reported Event|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
1223923|NCT00192036|B1|Baseline|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).~Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5."
1223924|NCT00192036|P1|Participant Flow|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).~Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5."
1224546|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
1223925|NCT00192036|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).~Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5."
1223926|NCT00192036|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).~Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5."
1223927|NCT00192036|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).~Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5."
1223928|NCT00192036|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).~Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5."
1223929|NCT00192036|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).~Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5."
1223930|NCT00192036|E1|Reported Event|Gemcitabine + Cisplatin|Gemcitabine: 1250 mg/m2, IV, day 1 and day 8 q 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5) Cisplatin: 80 mg/m2, IV, q 21 days x 5 cycles Radiation: 63 Gy in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5
1223931|NCT00192023|B3|Baseline|Total|Total of all reporting groups
1223932|NCT00192023|B2|Baseline|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
1223933|NCT00192023|B1|Baseline|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
1223934|NCT00192023|P2|Participant Flow|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
1223935|NCT00192023|P1|Participant Flow|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
1223936|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
1223937|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
1223938|NCT00192023|O2|Outcome|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
1223939|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
1223940|NCT00192023|O2|Outcome|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
1223941|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
1223942|NCT00192023|O2|Outcome|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
1223943|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
1223944|NCT00192023|O2|Outcome|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
1223945|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
1223946|NCT00192023|O2|Outcome|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
1223947|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
1223948|NCT00192023|O2|Outcome|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
1223949|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
1223950|NCT00192023|O2|Outcome|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
1223951|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
1224324|NCT00191165|O1|Outcome|High Dose Somatropin|Somatropin: 0.05 to 0.07 milligram/kilogram/day subcutaneous injection
1223952|NCT00192023|O2|Outcome|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
1223953|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
1223954|NCT00192023|E2|Reported Event|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
1223955|NCT00192023|E1|Reported Event|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
1223956|NCT00191984|B1|Baseline|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
1223957|NCT00191984|P1|Participant Flow|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
1223958|NCT00191984|O1|Outcome|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
1223959|NCT00191984|O1|Outcome|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
1223960|NCT00191984|O1|Outcome|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
1223961|NCT00191984|O1|Outcome|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
1223962|NCT00191984|O1|Outcome|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
1223963|NCT00191984|E1|Reported Event|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
1223964|NCT00191945|B3|Baseline|Total|Total of all reporting groups
1223965|NCT00191945|B2|Baseline|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
1223966|NCT00191945|B1|Baseline|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
1223967|NCT00191945|P2|Participant Flow|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
1223968|NCT00191945|P1|Participant Flow|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
1223969|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
1223970|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
1223971|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
1223972|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
1223973|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
1223974|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
1223975|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
1223976|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
1223977|NCT00191945|O1|Outcome|Atomoxetine|0.5 mg/kg/day QD, PO for 2 weeks, 1.2 - 1.4 mg/kg/day QD, PO for 10 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1 year
1223978|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
1223979|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
1223980|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
1223981|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
1223982|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
1223983|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
1223984|NCT00191945|O1|Outcome|Atomoxetine|0.5 mg/kg/day QD, PO for 2 weeks, 1.2 - 1.4 mg/kg/day QD, PO for 10 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1 year
1223985|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
1223986|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
1223987|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
1223988|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
1223989|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
1223990|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
1223991|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
1223992|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
1223993|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
1223994|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
1223995|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
1223996|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
1223997|NCT00191945|E2|Reported Event|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
1223998|NCT00191945|E1|Reported Event|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
1223999|NCT00191906|B5|Baseline|Total|Total of all reporting groups
1224000|NCT00191906|B4|Baseline|Reading Disordered Control|Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
1224001|NCT00191906|B3|Baseline|Normal Control|Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.
1224002|NCT00191906|B2|Baseline|Placebo First, Then Atomoxetine|Placebo for 4 weeks, 2 week washout, and then atomoxetine 1.2 mg/kg/day for 4 weeks.
1224003|NCT00191906|B1|Baseline|Atomoxetine First, Then Placebo|Atomoxetine 1.2 mg/kg/day for 4 weeks, 2 week washout, and then placebo for 4 weeks
1224004|NCT00191906|P4|Participant Flow|Reading Disordered Control|Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
1224005|NCT00191906|P3|Participant Flow|Normal Control|Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.
1224006|NCT00191906|P2|Participant Flow|Placebo First, Then Atomoxetine|Placebo every day, by mouth for 4 weeks, 2 week washout period and then cross-over to atomoxetine 1.2 mg/kg/day, by mouth for 4 weeks.
1224007|NCT00191906|P1|Participant Flow|Atomoxetine First, Then Placebo|Atomoxetine 1.2 mg/kg/day, by mouth for 4 weeks, 2 week washout period and then cross-over to placebo, every day, by mouth for 4 weeks.
1224008|NCT00191906|O3|Outcome|Reading Disordered Control|Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
1224009|NCT00191906|O2|Outcome|Reading Disorder|atomoxetine-treated Reading Disorder
1224010|NCT00191906|O1|Outcome|ADHD-C+RD|atomoxetine-treated Attention-Deficit/Hyperactivity Disorder-Combined Type + Reading Disorder
1224011|NCT00191906|O3|Outcome|Reading Disordered Control|Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
1224012|NCT00191906|O2|Outcome|Reading Disorder|atomoxetine-treated Reading Disorder
1224013|NCT00191906|O1|Outcome|ADHD-C+ RD|atomoxetine-treated Comorbid Attention-Deficit/Hyperactivity Disorder-Combined Type + Reading Disorder
1224014|NCT00191906|O2|Outcome|Normal Control|Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.
1224015|NCT00191906|O1|Outcome|ADHD-C|atomoxetine-treated Attention-Deficit/Hyperactivity Disorder-Combined Type
1224166|NCT00191477|O1|Outcome|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
1224016|NCT00191906|O2|Outcome|Normal Control|Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.
1224017|NCT00191906|O1|Outcome|ADHD-C|atomoxetine-treated Attention-Deficit/Hyperactivity Disorder-Combined Type
1224018|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
1224019|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
1224020|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
1224021|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
1224022|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
1224023|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
1224024|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
1224025|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
1224026|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
1224027|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
1224028|NCT00191906|O2|Outcome|Placebo|
1224029|NCT00191906|O1|Outcome|Atomoxetine|
1224030|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
1224031|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
1224032|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
1224033|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
1224034|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
1224035|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
1224036|NCT00191906|O3|Outcome|Reading Disordered Control|Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
1224037|NCT00191906|O2|Outcome|Reading Disorder|atomoxetine-treated Reading Disorder
1224038|NCT00191906|O1|Outcome|ADHD-C+RD|atomoxetine-treated Comorbid Attention-Deficit/Hyperactivity Disorder-Combined Type + Reading Disorder
1224039|NCT00191906|O2|Outcome|Normal Control|Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.
1224040|NCT00191906|O1|Outcome|ADHD-C|atomoxetine-treated Attention-Deficit/Hyperactivity Disorder-Combined Type
1224041|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
1224042|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
1224043|NCT00191906|E3|Reported Event|Open Label Atomoxetine|Patients in the Open Label extension receiving Atomoxetine
1224044|NCT00191906|E2|Reported Event|As Randomized Atomoxetine (Crossover)|Patients in either Crossover Period receiving Atomoxetine
1224045|NCT00191906|E1|Reported Event|As Randomized Placebo (Crossover)|Patients in either Crossover Period receiving Placebo
1224046|NCT00191854|B4|Baseline|Total|Total of all reporting groups
1224047|NCT00191854|B3|Baseline|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
1224048|NCT00191854|B2|Baseline|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
1224049|NCT00191854|B1|Baseline|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
1224050|NCT00191854|P3|Participant Flow|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
1224051|NCT00191854|P2|Participant Flow|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
1224052|NCT00191854|P1|Participant Flow|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
1224053|NCT00191854|O3|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
1224054|NCT00191854|O2|Outcome|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
1224055|NCT00191854|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
1224056|NCT00191854|O3|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
1224057|NCT00191854|O2|Outcome|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
1224058|NCT00191854|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
1224059|NCT00191854|O3|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
1224060|NCT00191854|O2|Outcome|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
1231184|NCT00150618|O3|Outcome|SPD503 (3 mg)|Guanfacine HCl once daily
1224061|NCT00191854|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
1224167|NCT00191477|O2|Outcome|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
1224062|NCT00191854|O3|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
1224063|NCT00191854|O2|Outcome|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
1224064|NCT00191854|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
1224065|NCT00191854|O3|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
1224066|NCT00191854|O2|Outcome|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
1224067|NCT00191854|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
1224068|NCT00191854|E3|Reported Event|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
1224069|NCT00191854|E2|Reported Event|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
1224070|NCT00191854|E1|Reported Event|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
1224071|NCT00191815|B1|Baseline|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
1224072|NCT00191815|P1|Participant Flow|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
1224073|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
1224074|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
1224075|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
1224076|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
1224077|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
1224078|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
1224079|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
1224080|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
1224081|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
1224082|NCT00191815|E1|Reported Event|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
1224083|NCT00191789|B1|Baseline|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
1224084|NCT00191789|P1|Participant Flow|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
1224085|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
1224086|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
1224163|NCT00191477|O2|Outcome|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
1224990|NCT00186888|O2|Outcome|6 Months|Participants at 6 months of age ±3 months.
1224168|NCT00191477|O1|Outcome|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
1224087|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
1224088|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
1224089|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
1224090|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
1224091|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
1224092|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
1224093|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
1224094|NCT00191789|E1|Reported Event|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
1224095|NCT00191724|B6|Baseline|Total|Total of all reporting groups
1224096|NCT00191724|B5|Baseline|Placebo|Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224097|NCT00191724|B4|Baseline|Drotrecogin Alfa (Activated) - 24|Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224098|NCT00191724|B3|Baseline|Drotrecogin Alfa (Activated) - 18|Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224099|NCT00191724|B2|Baseline|Drotrecogin Alfa (Activated) - 12|Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224100|NCT00191724|B1|Baseline|Drotrecogin Alfa (Activated) - 6|Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224101|NCT00191724|P5|Participant Flow|Placebo|Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224102|NCT00191724|P4|Participant Flow|Drotrecogin Alfa (Activated) - 24|Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224103|NCT00191724|P3|Participant Flow|Drotrecogin Alfa (Activated) - 18|Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224104|NCT00191724|P2|Participant Flow|Drotrecogin Alfa (Activated) - 12|Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224105|NCT00191724|P1|Participant Flow|Drotrecogin Alfa (Activated) - 6|Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224106|NCT00191724|O5|Outcome|Placebo|Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224107|NCT00191724|O4|Outcome|Drotrecogin Alfa (Activated) - 24|Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224319|NCT00191165|O2|Outcome|Label Dose Somatropin|Somatropin: 0.025 to 0.035 milligram/kilogram/day subcutaneous injection
1224108|NCT00191724|O3|Outcome|Drotrecogin Alfa (Activated) - 18|Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224109|NCT00191724|O2|Outcome|Drotrecogin Alfa (Activated) - 12|Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224110|NCT00191724|O1|Outcome|Drotrecogin Alfa (Activated) - 6|Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224111|NCT00191724|O5|Outcome|Placebo|Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224112|NCT00191724|O4|Outcome|Drotrecogin Alfa (Activated) - 24|Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224113|NCT00191724|O3|Outcome|Drotrecogin Alfa (Activated) - 18|Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224114|NCT00191724|O2|Outcome|Drotrecogin Alfa (Activated) - 12|Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224115|NCT00191724|O1|Outcome|Drotrecogin Alfa (Activated) - 6|Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224116|NCT00191724|O5|Outcome|Placebo|Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224117|NCT00191724|O4|Outcome|Drotrecogin Alfa (Activated) - 24|Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224118|NCT00191724|O3|Outcome|Drotrecogin Alfa (Activated) - 18|Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224119|NCT00191724|O2|Outcome|Drotrecogin Alfa (Activated) - 12|Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224120|NCT00191724|O1|Outcome|Drotrecogin Alfa (Activated) - 6|Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224121|NCT00191724|O5|Outcome|Placebo|Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224122|NCT00191724|O4|Outcome|Drotrecogin Alfa (Activated) - 24|Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224123|NCT00191724|O3|Outcome|Drotrecogin Alfa (Activated) - 18|Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224124|NCT00191724|O2|Outcome|Drotrecogin Alfa (Activated) - 12|Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224125|NCT00191724|O1|Outcome|Drotrecogin Alfa (Activated) - 6|Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224126|NCT00191724|E5|Reported Event|Placebo|Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224127|NCT00191724|E4|Reported Event|Drotrecogin Alfa (Activated) - 24|Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224128|NCT00191724|E3|Reported Event|Drotrecogin Alfa (Activated) - 18|Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224129|NCT00191724|E2|Reported Event|Drotrecogin Alfa (Activated) - 12|Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224130|NCT00191724|E1|Reported Event|Drotrecogin Alfa (Activated) - 6|Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
1224131|NCT00191646|B3|Baseline|Total|Total of all reporting groups
1224132|NCT00191646|B2|Baseline|Paclitaxel/Carboplatin|"Induction: Paclitaxel 175 mg/m^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m^2 IVPB, 3 hours every 28 days for 12 cycles (one year).~Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m^2 days 1, 8 to be repeated every 21 days."
1224164|NCT00191477|O1|Outcome|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
1224320|NCT00191165|O1|Outcome|High Dose Somatropin|Somatropin: 0.05 to 0.07 milligram/kilogram/day subcutaneous injection
1224133|NCT00191646|B1|Baseline|Gemcitabine/Carboplatin|"Induction: Gemcitabine 1000 mg/m^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.~Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).~Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m^2 day 1 to be repeated every 21 days."
1224134|NCT00191646|P2|Participant Flow|Paclitaxel/Carboplatin|"Induction: Paclitaxel 175 mg/m^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m^2 IVPB, 3 hours every 28 days for 12 cycles (one year).~Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m^2 days 1, 8 to be repeated every 21 days."
1224135|NCT00191646|P1|Participant Flow|Gemcitabine/Carboplatin|"Induction: Gemcitabine 1000 mg/m^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.~Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).~Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m^2 day 1 to be repeated every 21 days."
1224136|NCT00191646|O2|Outcome|Paclitaxel/Carboplatin|"Induction: Paclitaxel 175 mg/m^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m^2 IVPB, 3 hours every 28 days for 12 cycles (one year).~Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m^2 days 1, 8 to be repeated every 21 days."
1224137|NCT00191646|O1|Outcome|Gemcitabine/Carboplatin|"Induction: Gemcitabine 1000 mg/m^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.~Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).~Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m^2 day 1 to be repeated every 21 days."
1224138|NCT00191646|O2|Outcome|Paclitaxel/Carboplatin|"Induction: Paclitaxel 175 mg/m^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m^2 IVPB, 3 hours every 28 days for 12 cycles (one year).~Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m^2 days 1, 8 to be repeated every 21 days."
1224139|NCT00191646|O1|Outcome|Gemcitabine/Carboplatin|"Induction: Gemcitabine 1000 mg/m^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.~Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).~Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m^2 day 1 to be repeated every 21 days."
1224140|NCT00191646|O4|Outcome|Paclitaxel (Crossover)|Crossover (From Gemcitabine to Paclitaxel) - If no complete response on Gemcitabine, patient crossed over to receive Paclitaxel 175 mg/m^2, IV, day 1, q 21 days until complete response, disease progression or unacceptable toxicity
1224141|NCT00191646|O3|Outcome|Gemcitabine (Crossover)|Crossover (From Paclitaxel to Gemcitabine) - If no complete response on Paclitaxel, patient crossed over to receive Gemcitabine 1000 mg/m^2, IV, day 1 and day 8 q 21 days until complete response, disease progression or unacceptable toxicity
1224142|NCT00191646|O2|Outcome|Paclitaxel/Carboplatin (Induction)|Paclitaxel 175 milligrams per meter square (mg/m^2) administered intravenously (IV) Day 1 Carboplatin AUC 6 Day 1, six 21-day cycles
1224143|NCT00191646|O1|Outcome|Gemcitabine/Carboplatin (Induction)|Gemcitabine 1000 milligrams per meter square (mg/m^2) Day 1, Day 8, Carboplatin AUC 5 Day 1, six 21-day cycles
1224144|NCT00191646|O2|Outcome|Paclitaxel/Carboplatin|"Induction: Paclitaxel 175 mg/m^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m^2 IVPB, 3 hours every 28 days for 12 cycles (one year).~Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m^2 days 1, 8 to be repeated every 21 days."
1224145|NCT00191646|O1|Outcome|Gemcitabine/Carboplatin|"Induction: Gemcitabine 1000 mg/m^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.~Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).~Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m^2 day 1 to be repeated every 21 days."
1224146|NCT00191646|E6|Reported Event|Crossover (Gemcitabine to Paclitaxel)|Single agent Paclitaxel 175mg/m2 IV Day 1 to be repeated every 21 days.
1224147|NCT00191646|E5|Reported Event|Crossover (Paclitaxel to Gemcitabine)|Single agent Gemcitabine 1000mg/m2 IV, Day 1, Day 8 to be repeated every 21 days.
1224148|NCT00191646|E4|Reported Event|Consolidation (Paclitaxel to Paclitaxel)|Paclitaxel 135mg/m2 IV/3 hours every 28 days for 12 cycles (one year).
1224149|NCT00191646|E3|Reported Event|Consolidation (Gemcitabine to Paclitaxel)|Paclitaxel 135mg/m2 IV/3 hours every 28 days for 12 cycles (one year).
1224150|NCT00191646|E2|Reported Event|Paclitaxel/Carboplatin Induction|Paclitaxel 175 milligrams per meter square (mg/m2) administered intravenously (IV) Day 1 Carboplatin AUC 6 Day 1, 6 21 day cycles
1224151|NCT00191646|E1|Reported Event|Gemcitabine/Carboplatin Induction|Gemcitabine 1000 milligrams per meter square (mg/m2) Day 1, Day 8, Carboplatin AUC 5 Day 1, 6 21 day cycles
1224152|NCT00191477|B3|Baseline|Total|Total of all reporting groups
1224153|NCT00191477|B2|Baseline|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
1224154|NCT00191477|B1|Baseline|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
1224155|NCT00191477|P2|Participant Flow|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
1224156|NCT00191477|P1|Participant Flow|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
1224157|NCT00191477|O2|Outcome|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
1224158|NCT00191477|O1|Outcome|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
1224159|NCT00191477|O2|Outcome|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
1224160|NCT00191477|O1|Outcome|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
1224161|NCT00191477|O2|Outcome|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
1224162|NCT00191477|O1|Outcome|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
1224991|NCT00186888|O1|Outcome|Baseline|At study entry.
1224169|NCT00191477|E2|Reported Event|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of bladder tumor (TUR-BT)
1224170|NCT00191477|E1|Reported Event|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of bladder tumor (TUR-BT)
1224171|NCT00191451|B4|Baseline|Total|Total of all reporting groups
1224172|NCT00191451|B3|Baseline|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
1224173|NCT00191451|B2|Baseline|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
1224174|NCT00191451|B1|Baseline|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
1224175|NCT00191451|P3|Participant Flow|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
1224176|NCT00191451|P2|Participant Flow|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
1224177|NCT00191451|P1|Participant Flow|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
1224178|NCT00191451|O3|Outcome|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
1224179|NCT00191451|O2|Outcome|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
1224180|NCT00191451|O1|Outcome|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
1224181|NCT00191451|O3|Outcome|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
1224182|NCT00191451|O2|Outcome|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
1224183|NCT00191451|O1|Outcome|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
1224184|NCT00191451|O3|Outcome|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
1224204|NCT00191334|P1|Participant Flow|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.~Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
1224185|NCT00191451|O2|Outcome|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
1224321|NCT00191165|O2|Outcome|Label Dose Somatropin|Somatropin: 0.025 to 0.035 milligram/kilogram/day subcutaneous injection
1224186|NCT00191451|O1|Outcome|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
1224187|NCT00191451|O3|Outcome|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
1224188|NCT00191451|O2|Outcome|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
1224189|NCT00191451|O1|Outcome|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
1224190|NCT00191451|O3|Outcome|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
1224191|NCT00191451|O2|Outcome|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
1224192|NCT00191451|O1|Outcome|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
1224193|NCT00191451|E3|Reported Event|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
1224194|NCT00191451|E2|Reported Event|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
1224195|NCT00191451|E1|Reported Event|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
1224196|NCT00191386|B1|Baseline|Atomoxetine|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
1224197|NCT00191386|P1|Participant Flow|Atomoxetine|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
1224198|NCT00191386|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
1224199|NCT00191386|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
1224200|NCT00191386|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
1224201|NCT00191386|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
1224202|NCT00191386|E1|Reported Event|Atomoxetine|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
1224203|NCT00191334|B1|Baseline|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.~Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
1224314|NCT00191165|B3|Baseline|Total|Total of all reporting groups
1224315|NCT00191165|B2|Baseline|Label Dose Somatropin|Somatropin: 0.025 to 0.035 milligram/kilogram/day subcutaneous injection
1224205|NCT00191334|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.~Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
1224377|NCT00191113|B3|Baseline|Total|Total of all reporting groups
1224206|NCT00191334|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.~Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
1224207|NCT00191334|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.~Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
1224208|NCT00191334|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.~Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
1224209|NCT00191334|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.~Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
1224210|NCT00191334|E1|Reported Event|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.~Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
1224211|NCT00191308|B1|Baseline|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.~Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
1224212|NCT00191308|P1|Participant Flow|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.~Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
1224213|NCT00191308|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.~Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
1224214|NCT00191308|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.~Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
1224215|NCT00191308|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.~Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
1224216|NCT00191308|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.~Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
1224217|NCT00191308|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.~Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
1224218|NCT00191308|E1|Reported Event|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.~Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
1224219|NCT00191282|B3|Baseline|Total|Total of all reporting groups
1224220|NCT00191282|B2|Baseline|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
1224221|NCT00191282|B1|Baseline|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
1224222|NCT00191282|P2|Participant Flow|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
1224223|NCT00191282|P1|Participant Flow|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
1224224|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
1224225|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
1224226|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
1224322|NCT00191165|O1|Outcome|High Dose Somatropin|Somatropin: 0.05 to 0.07 milligram/kilogram/day subcutaneous injection
1224323|NCT00191165|O2|Outcome|Label Dose Somatropin|Somatropin: 0.025 to 0.035 milligram/kilogram/day subcutaneous injection
1224227|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
1224228|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
1224229|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
1224230|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
1224231|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
1224232|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
1224233|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
1224234|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
1224235|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
1224236|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
1224237|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
1224238|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
1224239|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
1224240|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
1224241|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
1224242|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
1224316|NCT00191165|B1|Baseline|High Dose Somatropin|Somatropin: 0.05 to 0.07 milligram/kilogram/day subcutaneous injection
1224243|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
1224244|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
1224245|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
1224246|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
1224247|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
1224248|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
1224249|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
1224250|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
1224251|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
1224252|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
1224253|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
1224254|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
1224255|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
1224256|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
1224257|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
1224258|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
1224317|NCT00191165|P2|Participant Flow|Label Dose Somatropin|Somatropin: 0.025 to 0.035 milligram/kilogram/day subcutaneous injection
1224259|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
1224260|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
1224261|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
1224262|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
1224263|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
1224264|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
1224265|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
1224266|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
1224267|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
1224268|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
1224269|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
1224270|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
1224271|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
1224272|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
1224273|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
1224274|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
1224318|NCT00191165|P1|Participant Flow|High Dose Somatropin|Somatropin: 0.05 to 0.07 milligram/kilogram/day subcutaneous injection
1224275|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
1224276|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
1224277|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
1224278|NCT00191282|E2|Reported Event|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
1224279|NCT00191282|E1|Reported Event|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
1224280|NCT00191269|B3|Baseline|Total|Total of all reporting groups
1224281|NCT00191269|B2|Baseline|Dose Level 2|Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
1224282|NCT00191269|B1|Baseline|Dose Level 1|Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
1224283|NCT00191269|P2|Participant Flow|Dose Level 2|Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
1224284|NCT00191269|P1|Participant Flow|Dose Level 1|Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
1224285|NCT00191269|O1|Outcome|Dose Normalized to 1250 Milligrams Per Square Meter|12 participants with a mean gemcitabine dose of 1120 milligrams per square meter
1224286|NCT00191269|O1|Outcome|Dose Normalized to 1250 Milligrams Per Square Meter|12 participants with a mean gemcitabine dose of 1120 milligrams per square meter
1224287|NCT00191269|O2|Outcome|Dose Level 2|Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
1224288|NCT00191269|O1|Outcome|Dose Level 1|Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
1224289|NCT00191269|O2|Outcome|Dose Level 2|Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
1224290|NCT00191269|O1|Outcome|Dose Level 1|Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
1224291|NCT00191269|O2|Outcome|Dose Level 2|Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
1224292|NCT00191269|O1|Outcome|Dose Level 1|Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
1224293|NCT00191269|O2|Outcome|Dose Level 2|Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
1224294|NCT00191269|O1|Outcome|Dose Level 1|Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
1224295|NCT00191269|E2|Reported Event|Dose Level 2|Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
1224296|NCT00191269|E1|Reported Event|Dose Level 1|Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
1224297|NCT00191191|B3|Baseline|Total|Total of all reporting groups
1224298|NCT00191191|B2|Baseline|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
1224299|NCT00191191|B1|Baseline|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
1224300|NCT00191191|P2|Participant Flow|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
1224301|NCT00191191|P1|Participant Flow|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
1224302|NCT00191191|O2|Outcome|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
1224303|NCT00191191|O1|Outcome|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
1224304|NCT00191191|O2|Outcome|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
1224305|NCT00191191|O1|Outcome|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
1224306|NCT00191191|O2|Outcome|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
1224307|NCT00191191|O1|Outcome|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
1224308|NCT00191191|O2|Outcome|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
1224309|NCT00191191|O1|Outcome|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
1224310|NCT00191191|O2|Outcome|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
1224311|NCT00191191|O1|Outcome|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
1224312|NCT00191191|E2|Reported Event|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
1224313|NCT00191191|E1|Reported Event|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
1224325|NCT00191165|E2|Reported Event|Label Dose Somatropin|Somatropin: 0.025 to 0.035 milligram/kilogram/day subcutaneous injection
1224326|NCT00191165|E1|Reported Event|High Dose Somatropin|Somatropin: 0.05 to 0.07 milligram/kilogram/day subcutaneous injection
1224327|NCT00191152|B3|Baseline|Total|Total of all reporting groups
1224328|NCT00191152|B2|Baseline|Docetaxel Plus Capecitabine|"Initial treatment: Docetaxel 75 milligrams per meter squared (mg/m2), intravenous (IV) on Day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth (PO), twice a day (BID),Days 1-14, every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.~Crossover treatment: gemcitabine 1000 mg/m2, IV, Days 1 and 8, every 21 days. This treatment continues until PD at which time all treatment is discontinued."
1224329|NCT00191152|B1|Baseline|Gemcitabine Plus Docetaxel|"Initial treatment: Gemcitabine 1000 milligrams per meter squared (mg/m2), intravenous (IV) on Days 1 and 8 every 21 days plus docetaxel 75 mg/m2 IV on Day 1 every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.~Crossover treatment: capecitabine 1000 mg/m2 by mouth (PO)twice a day (BID), Days 1-14, every 21 days until progressive disease (PD) at which time all treatment is discontinued."
1224330|NCT00191152|P2|Participant Flow|Docetaxel Plus Capecitabine|"Initial treatment: Docetaxel 75 milligrams per meter squared (mg/m2), intravenous (IV) on Day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth (PO), twice a day (BID), Days 1-14, every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.~Crossover treatment: gemcitabine 1000 mg/m2, IV, Days 1 and 8, every 21 days. This treatment continues until PD at which time all treatment is discontinued."
1224331|NCT00191152|P1|Participant Flow|Gemcitabine Plus Docetaxel|"Initial treatment: Gemcitabine 1000 milligrams per meter squared (mg/m2),intravenous (IV) on Days 1 and 8 every 21 days plus docetaxel 75 mg/m2 IV on Day 1 every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.~Crossover treatment: capecitabine 1000 mg/m2 by mouth (PO) twice a day (BID), Days 1-14, every 21 days until PD at which time all treatment is discontinued. PD during crossover was defined as the Response Evaluation Criteria in Solid Tumors (RECIST) guideline with the tumor measurement at the start of crossover treatment (or end of initial treatment) considered as the crossover baseline, with subsequent tumor measurements during crossover treatment compared to the crossover baseline."
1224332|NCT00191152|O2|Outcome|Gemcitabine|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.
1224333|NCT00191152|O1|Outcome|Capecitabine|capecitabine 1000 mg/m2, by mouth twice day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued.
1224334|NCT00191152|O2|Outcome|Docetaxel Plus Capecitabine|docetaxel 75 mg/m2, intravenous on Day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth, twice a day, days 1-14, every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
1224335|NCT00191152|O1|Outcome|Gemcitabine Plus Docetaxel|gemcitabine 1000 mg/m2, intravenous, on Days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, on Day 1 every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
1224336|NCT00191152|O2|Outcome|Gemcitabine|gemcitabine 1000 mg/m2 intravenously, days 1 and 8, every 21 days
1224337|NCT00191152|O1|Outcome|Capecitabine|capecitabine 1000 mg/m2, by mouth two times per day, days 1-14, every 21 days
1224338|NCT00191152|O2|Outcome|Docetaxel Plus Capecitabine|docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14, every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
1224339|NCT00191152|O1|Outcome|Gemcitabine Plus Docetaxel|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
1224340|NCT00191152|O2|Outcome|Gemcitabine|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.
1224341|NCT00191152|O1|Outcome|Capecitabine|capecitabine 1000 mg/m2, by mouth two times per day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued.
1224342|NCT00191152|O2|Outcome|Docetaxel Plus Capecitabine|docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14, every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
1224343|NCT00191152|O1|Outcome|Gemcitabine Plus Docetaxel|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
1224344|NCT00191152|O2|Outcome|Docetaxel Plus Capecitabine|docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14 every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
1224345|NCT00191152|O1|Outcome|Gemcitabine Plus Docetaxel|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
1224346|NCT00191152|O2|Outcome|Gemcitabine|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.
1224347|NCT00191152|O1|Outcome|Capecitabine|capecitabine 1000 mg/m2, by mouth two times per day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued.
1224348|NCT00191152|O2|Outcome|Docetaxel Plus Capecitabine|docetaxel 75 mg/m2, intravenous, on day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14, every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
1224539|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
1224349|NCT00191152|O1|Outcome|Gemcitabine Plus Docetaxel|gemcitabine 1000 mg/m2, intravenous on days 1 and 8 every 21 days plus docetaxel 75 mg/m2 intravenous on day 1 every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
1224350|NCT00191152|O2|Outcome|Docetaxel Plus Capecitabine|docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14 every 21 days. Treatment continues until progression of disease, at which time crossover treatment begins.
1224351|NCT00191152|O1|Outcome|Gemcitabine Plus Docetaxel|"gemcitabine 1000 milligrams per meter squared (mg/m2) intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days.~Treatment continues until progression of disease at which time crossover treatment begins."
1224352|NCT00191152|O2|Outcome|Gemcitabine|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.
1224353|NCT00191152|O1|Outcome|Capecitabine|capecitabine 1000 mg/m2, by mouth two times per day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued.
1224354|NCT00191152|O2|Outcome|Docetaxel Plus Capecitabine|docetaxel 75 mg/m2, intravenous, on day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14, every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
1224355|NCT00191152|O1|Outcome|Gemcitabine Plus Docetaxel|gemcitabine 1000 mg/m2, intravenous on days 1 and 8 every 21 days plus docetaxel 75 mg/m2 intravenous on day 1 every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
1224356|NCT00191152|O2|Outcome|Gemcitabine|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.
1224357|NCT00191152|O1|Outcome|Capecitabine|capecitabine 1000 mg/m2, by mouth two times per day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued.
1224358|NCT00191152|E2|Reported Event|Docetaxel Plus Capecitabine|"Initial treatment: Docetaxel 75 milligrams per meter squared (mg/m2), intravenous (IV) on Day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth (PO), twice a day (BID), Days 1-14, every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.~Crossover treatment: gemcitabine 1000 mg/m2, IV, Days 1 and 8, every 21 days. This treatment continues until PD at which time all treatment is discontinued."
1224359|NCT00191152|E1|Reported Event|Gemcitabine Plus Docetaxel|"Initial treatment: Gemcitabine 1000 milligrams per meter squared (mg/m2), intravenous (IV) on Days 1 and 8 every 21 days plus docetaxel 75 mg/m2 IV on Day 1 every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.~Crossover treatment: capecitabine 1000 mg/m2 by mouth (PO) twice a day (BID), Days 1-14, every 21 days until PD at which time all treatment is discontinued."
1224360|NCT00191139|B3|Baseline|Total|Total of all reporting groups
1224361|NCT00191139|B2|Baseline|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
1224362|NCT00191139|B1|Baseline|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
1224363|NCT00191139|P2|Participant Flow|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
1224364|NCT00191139|P1|Participant Flow|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
1224365|NCT00191139|O2|Outcome|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
1224366|NCT00191139|O1|Outcome|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
1224367|NCT00191139|O2|Outcome|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
1224368|NCT00191139|O1|Outcome|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
1224369|NCT00191139|O2|Outcome|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
1224370|NCT00191139|O1|Outcome|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
1224371|NCT00191139|O2|Outcome|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
1224372|NCT00191139|O1|Outcome|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
1224373|NCT00191139|O2|Outcome|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
1224374|NCT00191139|O1|Outcome|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
1231185|NCT00150618|O2|Outcome|SPD503 (2 mg)|Guanfacine HCl once daily
1224375|NCT00191139|E2|Reported Event|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
1224376|NCT00191139|E1|Reported Event|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
1224378|NCT00191113|B2|Baseline|As-Randomized Humatrope|Humatrope (0.05 mg/kg/dose) by subcutaneous injection 6 times per week. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).
1224379|NCT00191113|B1|Baseline|As-Randomized Control|Control arm; untreated with Humatrope. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).
1224380|NCT00191113|P2|Participant Flow|As-Randomized Humatrope|Humatrope (0.05 mg/kg/dose) by subcutaneous injection 6 times per week. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).
1224381|NCT00191113|P1|Participant Flow|As-Randomized Control|Control arm; untreated with Humatrope. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).
1224382|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
1224383|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
1224384|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
1224385|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
1224386|NCT00191113|O2|Outcome|Treated-As-Randomized Humatrope|Patients in the As-Randomized Humatrope group who received Humatrope
1224387|NCT00191113|O1|Outcome|Treated-As-Randomized Control|Patients in As-Randomized Control group who at each observed time point remained untreated with growth hormone.
1224388|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
1224389|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
1224390|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
1224391|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
1224392|NCT00191113|O2|Outcome|As-Treated Growth Humatrope|Patients who received Humatrope or another brand of growth hormone
1224393|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
1224394|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
1224395|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
1224396|NCT00191113|O2|Outcome|As-Treated Growth Humatrope|Patients who received Humatrope or another brand of growth hormone
1224397|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
1224398|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
1224399|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
1224400|NCT00191113|O2|Outcome|Treated-As-Randomized Humatrope|Patients in As-Randomized Humatrope group who received Humatrope treatment
1224401|NCT00191113|O1|Outcome|Treated-As-Randomized Control|Patients in As-Randomized Control group who at each observed time point remained untreated with growth hormone.
1224402|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
1224403|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
1224404|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
1224405|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
1224406|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
1224407|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
1224408|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
1224409|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
1224410|NCT00191113|O2|Outcome|As-Treated Growth Humatrope|Patients who received Humatrope or another brand of growth hormone
1224411|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
1224412|NCT00191113|O2|Outcome|As-Treated Growth Humatrope|Patients who received Humatrope or another brand of growth hormone
1224413|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
1224414|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
1224415|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
1224416|NCT00191113|O2|Outcome|As-Randomized Humatrope|Humatrope (0.05 mg/kg/dose) by subcutaneous injection 6 times per week. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).
1224417|NCT00191113|O1|Outcome|As-Randomized Control|Control arm; untreated with Humatrope. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).
1224418|NCT00191113|E2|Reported Event|Treated-As-Randomized Humatrope|Patients in the As-Randomized Humatrope group who received Humatrope
1224419|NCT00191113|E1|Reported Event|Treated-As-Randomized Control|Patients in the As-Randomized Control group who at each observed time point remained untreated with growth hormone.
1224420|NCT00191100|B3|Baseline|Total|Total of all reporting groups
1224421|NCT00191100|B2|Baseline|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week"
1224543|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
1224422|NCT00191100|B1|Baseline|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week~Two week rest period with no chemotherapy or radiation~Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
1224423|NCT00191100|P2|Participant Flow|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week"
1224424|NCT00191100|P1|Participant Flow|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week~Two week rest period with no chemotherapy or radiation~Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
1224425|NCT00191100|O2|Outcome|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week"
1224426|NCT00191100|O1|Outcome|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week~Two week rest period with no chemotherapy or radiation~Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
1224427|NCT00191100|O2|Outcome|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week"
1224428|NCT00191100|O1|Outcome|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week~Two week rest period with no chemotherapy or radiation~Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
1224429|NCT00191100|O2|Outcome|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week"
1224430|NCT00191100|O1|Outcome|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week~Two week rest period with no chemotherapy or radiation~Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
1224431|NCT00191100|O2|Outcome|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week"
1224432|NCT00191100|O1|Outcome|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week~Two week rest period with no chemotherapy or radiation~Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
1224433|NCT00191100|O2|Outcome|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week"
1224434|NCT00191100|O1|Outcome|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week~Two week rest period with no chemotherapy or radiation~Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
1224435|NCT00191100|O2|Outcome|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week"
1224436|NCT00191100|O1|Outcome|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week~Two week rest period with no chemotherapy or radiation~Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
1224437|NCT00191100|E2|Reported Event|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week"
1224438|NCT00191100|E1|Reported Event|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week~Two week rest period with no chemotherapy or radiation~Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
1224439|NCT00190983|B1|Baseline|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
1224440|NCT00190983|P1|Participant Flow|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
1224441|NCT00190983|O1|Outcome|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
1224442|NCT00190983|O1|Outcome|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
1224443|NCT00190983|O1|Outcome|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
1224444|NCT00190983|O1|Outcome|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
1224445|NCT00190983|E1|Reported Event|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
1224446|NCT00190775|B3|Baseline|Total|Total of all reporting groups
1224447|NCT00190775|B2|Baseline|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
1224448|NCT00190775|B1|Baseline|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
1224449|NCT00190775|P2|Participant Flow|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
1224450|NCT00190775|P1|Participant Flow|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
1224451|NCT00190775|O3|Outcome|Atomoxetine|Atomoxetine for 24 weeks
1224452|NCT00190775|O2|Outcome|Placebo/Atomoxetine Group 2|Placebo for 24 weeks followed by atomoxetine 40 mg/day for 7 days followed by 80 mg/day for 7 days
1224453|NCT00190775|O1|Outcome|Placebo/Atomoxetine Group 1|Placebo for 24 Weeks followed by atomoxetine 40 milligrams (mg)/day for 3 days followed by 80 mg/day for 11 days
1224454|NCT00190775|O3|Outcome|Placebo|Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
1224455|NCT00190775|O2|Outcome|Atomoxetine Group 2|Atomoxetine 40 mg/day for 7 days followed by 80 mg/day for 7 days
1224456|NCT00190775|O1|Outcome|Atomoxetine Group 1|Atomoxetine 40 milligrams (mg)/day for 3 days followed by 80 mg/day for 11 days
1224457|NCT00190775|O3|Outcome|Placebo|Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
1224458|NCT00190775|O2|Outcome|Atomoxetine Group 2|Atomoxetine 40 mg/day for 7 days followed by 80 mg/day for 7 days
1224459|NCT00190775|O1|Outcome|Atomoxetine Group 1|Atomoxetine 40 milligrams (mg)/day for 3 days followed by 80 mg/day for 4 days
1224460|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
1224461|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
1224462|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
1224463|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
1224464|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
1224465|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
1224466|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
1224467|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
1224468|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
1224469|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
1224470|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
1224471|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
1224472|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
1224473|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
1224474|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
1231186|NCT00150618|O1|Outcome|SPD503 (1 mg)|Guanfacine HCl once daily
1224475|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
1224544|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
1224545|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
1224476|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
1224477|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
1224478|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
1224479|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
1224480|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
1224481|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
1224482|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
1224483|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
1224484|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
1224485|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
1224486|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
1224487|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
1224488|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
1224489|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
1224490|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
1224491|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
1224492|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
1224493|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
1224494|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
1224495|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
1224496|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
1224497|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
1224498|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
1224499|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
1224500|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
1224501|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
1224502|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
1224503|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
1224504|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
1224505|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
1224506|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
1224507|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
1224508|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
1224509|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
1224510|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
1224511|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
1224512|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
1224513|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
1224514|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
1224515|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
1224516|NCT00190775|E2|Reported Event|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
1224517|NCT00190775|E1|Reported Event|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
1224518|NCT00190749|B3|Baseline|Total|Total of all reporting groups
1224519|NCT00190749|B2|Baseline|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
1224520|NCT00190749|B1|Baseline|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
1224521|NCT00190749|P2|Participant Flow|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
1224522|NCT00190749|P1|Participant Flow|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
1224523|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
1224524|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
1224525|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
1224526|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
1224527|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
1224528|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
1224529|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
1224530|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
1224531|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
1224532|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
1224533|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
1224534|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
1224535|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
1224536|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
1224537|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
1224538|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
1231187|NCT00150618|E5|Reported Event|Placebo|once daily
1224541|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
1224542|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
1224547|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
1224548|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
1224549|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
1224550|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
1224551|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
1224552|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
1224553|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
1224554|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
1224555|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
1224556|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
1224557|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
1224558|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
1224559|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
1224560|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
1224561|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
1224562|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
1224563|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
1224564|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
1224565|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
1224566|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
1224567|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
1224568|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
1224569|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
1224570|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
1224571|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
1224572|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
1224573|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
1224574|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
1224575|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
1224576|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
1224577|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
1224578|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
1224579|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
1224580|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
1224581|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
1224582|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
1224583|NCT00190749|E2|Reported Event|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
1224584|NCT00190749|E1|Reported Event|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
1224585|NCT00190684|B1|Baseline|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
1224586|NCT00190684|P1|Participant Flow|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
1224587|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
1224588|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
1224589|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
1224590|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
1233022|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1224591|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
1224592|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
1224593|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
1224594|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
1224595|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
1224596|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
1224597|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
1224598|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
1224599|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
1224600|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
1224601|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
1224602|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
1224603|NCT00190684|E1|Reported Event|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
1224604|NCT00190671|B3|Baseline|Total|Total of all reporting groups
1224605|NCT00190671|B2|Baseline|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
1224606|NCT00190671|B1|Baseline|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
1224607|NCT00190671|P2|Participant Flow|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
1224608|NCT00190671|P1|Participant Flow|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
1224609|NCT00190671|O2|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
1224610|NCT00190671|O1|Outcome|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
1224611|NCT00190671|O2|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
1224612|NCT00190671|O1|Outcome|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
1224613|NCT00190671|O2|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
1224614|NCT00190671|O1|Outcome|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
1224615|NCT00190671|O2|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
1224616|NCT00190671|O1|Outcome|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
1224617|NCT00190671|O2|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
1224618|NCT00190671|O1|Outcome|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
1224619|NCT00190671|O1|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
1224620|NCT00190671|O1|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
1224621|NCT00190671|O2|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
1224622|NCT00190671|O1|Outcome|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
1224842|NCT00187200|O1|Outcome|Simultaneous Pacing V-V Timing|Patients maintained on simultaneous V-V delay
1224623|NCT00190671|E2|Reported Event|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
1224624|NCT00190671|E1|Reported Event|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
1224625|NCT00189540|B3|Baseline|Total|Total of all reporting groups
1224626|NCT00189540|B2|Baseline|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
1224627|NCT00189540|B1|Baseline|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
1224628|NCT00189540|P2|Participant Flow|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
1224629|NCT00189540|P1|Participant Flow|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
1224630|NCT00189540|O2|Outcome|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
1224631|NCT00189540|O1|Outcome|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
1224632|NCT00189540|O2|Outcome|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
1224633|NCT00189540|O1|Outcome|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
1224634|NCT00189540|O2|Outcome|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
1224635|NCT00189540|O1|Outcome|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
1224636|NCT00189540|O2|Outcome|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
1224637|NCT00189540|O1|Outcome|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
1224638|NCT00189540|O2|Outcome|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
1224639|NCT00189540|O1|Outcome|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
1224640|NCT00189540|O2|Outcome|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
1224641|NCT00189540|O1|Outcome|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
1224642|NCT00189540|E2|Reported Event|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
1224643|NCT00189540|E1|Reported Event|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
1224644|NCT00189488|B3|Baseline|Total|Total of all reporting groups
1224645|NCT00189488|B2|Baseline|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
1224646|NCT00189488|B1|Baseline|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
1224647|NCT00189488|P2|Participant Flow|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg. Participants received conditioning therapy starting at least 24 hours after the last 60 μg dose of palifermin. Allogeneic stem cell transplant occurred on Day 0. Methotrexate dosing began at least 24 hours after the 180 μg/kg dose of palifermin on Days 1, 3, 6 and (planned) 11 administration (toxicity allowing) at doses of 15, 10, 10 and 10 mg/m^2 respectively
1224648|NCT00189488|P1|Participant Flow|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin once prior to transplant and at least 96 hours from the previous placebo dose. Participants received conditioning therapy starting at least 24 hours after the last 60 μg/kg dose of placebo to palifermin. Allogeneic stem cell transplant occurred on Day 0. Methotrexate dosing began at least 24 hours after the dose of placebo to palifermin 180 μg/kg on Days 1, 3, 6 and (planned) 11 administration (toxicity allowing) at doses of 15, 10, 10 and 10 mg/m^2 respectively.
1224649|NCT00189488|O2|Outcome|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
1224650|NCT00189488|O1|Outcome|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
1224651|NCT00189488|O2|Outcome|Palifermin|PaPalifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
1224652|NCT00189488|O1|Outcome|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
1224653|NCT00189488|O2|Outcome|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
1224654|NCT00189488|O1|Outcome|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
1224655|NCT00189488|O2|Outcome|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
1224656|NCT00189488|O1|Outcome|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
1224657|NCT00189488|O2|Outcome|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
1224658|NCT00189488|O1|Outcome|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
1224659|NCT00189488|O2|Outcome|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
1224660|NCT00189488|O1|Outcome|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
1224661|NCT00189488|O2|Outcome|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
1224662|NCT00189488|O1|Outcome|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
1224663|NCT00189488|O2|Outcome|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
1224664|NCT00189488|O1|Outcome|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
1224665|NCT00189488|E2|Reported Event|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
1224666|NCT00189488|E1|Reported Event|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
1224667|NCT00189475|B3|Baseline|Total|Total of all reporting groups
1224668|NCT00189475|B2|Baseline|Placebo|Treated for 4 months with placebo
1224669|NCT00189475|B1|Baseline|Montelukast|"Treated for 4 months with montelukast 4 mg per day~Montelukast"
1224670|NCT00189475|P2|Participant Flow|Placebo|Treated for 4 months with placebo
1224671|NCT00189475|P1|Participant Flow|Montelukast|"Treated for 4 months with montelukast 4 mg per day~Montelukast"
1224672|NCT00189475|O2|Outcome|Placebo|Treated for 6 days with placebo
1224673|NCT00189475|O1|Outcome|Montelukast|Montelukast 10mg per day for 6 days
1224674|NCT00189475|E2|Reported Event|Placebo|Treated for 4 months with placebo
1224675|NCT00189475|E1|Reported Event|Montelukast|"Treated for 4 months with montelukast 4 mg per day~Montelukast"
1224676|NCT00189462|B3|Baseline|Total|Total of all reporting groups
1224677|NCT00189462|B2|Baseline|Placebo|Treatment with placebo for 4 months
1224678|NCT00189462|B1|Baseline|Montelukast|"Treatment with montelukast for 4 months (4 mg per day)~Montelukast"
1224679|NCT00189462|P2|Participant Flow|Placebo|Treatment with placebo for 4 months
1224680|NCT00189462|P1|Participant Flow|Montelukast|"Treatment with montelukast for 4 months (4 mg per day)~Montelukast"
1224681|NCT00189462|O2|Outcome|Placebo|Treatment with placebo for 4 months
1224682|NCT00189462|O1|Outcome|Montelukast|"Treatment with montelukast for 4 months (4 mg per day)~Montelukast"
1224683|NCT00189462|E2|Reported Event|Placebo|Treatment with placebo for 4 months
1224684|NCT00189462|E1|Reported Event|Montelukast|"Treatment with montelukast for 4 months (4 mg per day)~Montelukast"
1224685|NCT00189436|B3|Baseline|Total|Total of all reporting groups
1224686|NCT00189436|B2|Baseline|Usual Care|"Subject is treated with usual care as provided by the doctor. Usual care normally consists of treatment with albuterol with or without an oral steroid.~Usual care (albuterol with or without oral steroid): Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)"
1224687|NCT00189436|B1|Baseline|Treatment With Budesonide|"Subject is treated with nebulized budesonide 0.5 BID for 3 weeks~Nebulized Budesonide: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks"
1224688|NCT00189436|P2|Participant Flow|Usual Care|"Subject is treated with usual care as provided by the doctor. Usual care normally consists of treatment with albuterol with or without an oral steroid.~Usual care (albuterol with or without oral steroid): Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)"
1224689|NCT00189436|P1|Participant Flow|Treatment With Budesonide|"Subject is treated with nebulized budesonide 0.5 BID for 3 weeks~Nebulized Budesonide: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks"
1224690|NCT00189436|O2|Outcome|Usual Care|"Subject is treated with usual care as provided by the doctor. Usual care normally consists of treatment with albuterol with or without an oral steroid.~Usual care (albuterol with or without oral steroid): Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)"
1224691|NCT00189436|O1|Outcome|Treatment With Budesonide|"Subject is treated with nebulized budesonide 0.5 BID for 3 weeks~Nebulized Budesonide: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks"
1224692|NCT00189436|E2|Reported Event|Usual Care|"Subject is treated with usual care as provided by the doctor. Usual care normally consists of treatment with albuterol with or without an oral steroid.~Usual care (albuterol with or without oral steroid): Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)"
1224693|NCT00189436|E1|Reported Event|Treatment With Budesonide|"Subject is treated with nebulized budesonide 0.5 BID for 3 weeks~Nebulized Budesonide: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks"
1224694|NCT00189423|B3|Baseline|Total|Total of all reporting groups
1233098|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1224695|NCT00189423|B2|Baseline|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
1224696|NCT00189423|B1|Baseline|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
1224697|NCT00189423|P2|Participant Flow|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
1224698|NCT00189423|P1|Participant Flow|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
1224699|NCT00189423|O2|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
1224700|NCT00189423|O1|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
1224701|NCT00189423|O2|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
1224702|NCT00189423|O1|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
1224703|NCT00189423|O2|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
1224704|NCT00189423|O1|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
1224705|NCT00189423|O2|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
1224706|NCT00189423|O1|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
1224707|NCT00189423|O2|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
1224708|NCT00189423|O1|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
1224709|NCT00189423|O2|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
1224710|NCT00189423|O1|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
1224711|NCT00189423|O2|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
1224712|NCT00189423|O1|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
1224713|NCT00189423|O2|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
1224714|NCT00189423|O1|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
1224715|NCT00189423|E2|Reported Event|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
1224716|NCT00189423|E1|Reported Event|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
1224717|NCT00189306|B1|Baseline|Aldara|Aldara (imiquimod) cream 5%
1224718|NCT00189306|P1|Participant Flow|Aldara|Aldara (imiquimod) cream 5%
1224719|NCT00189306|O1|Outcome|Aldara|Aldara (imiquimod) cream 5%
1224720|NCT00189306|O1|Outcome|Aldara|Aldara (imiquimod) cream 5%
1224721|NCT00189306|E1|Reported Event|Aldara|Aldara (imiquimod) cream 5%
1224722|NCT00189202|B1|Baseline|Sirolimus, Steroid Avoidance Arm|"Thymoglobulin induction, sirolimus and no maintenance corticosteroid.~Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid"
1224723|NCT00189202|P1|Participant Flow|Sirolimus, Steroid Avoidance Arm|"Thymoglobulin induction, sirolimus and no maintenance corticosteroid.~Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid"
1224724|NCT00189202|O1|Outcome|Sirolimus, Steroid Avoidance Arm|"Thymoglobulin induction, sirolimus and no maintenance corticosteroid.~Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid"
1224725|NCT00189202|O1|Outcome|Sirolimus, Steroid Avoidance Arm|"Thymoglobulin induction, sirolimus and no maintenance corticosteroid.~Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid"
1224726|NCT00189202|O1|Outcome|Sirolimus, Steroid Avoidance Arm|"Thymoglobulin induction, sirolimus and no maintenance corticosteroid.~Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid"
1224727|NCT00189202|O1|Outcome|Sirolimus, Steroid Avoidance Arm|"Thymoglobulin induction, sirolimus and no maintenance corticosteroid.~Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid"
1224728|NCT00189202|O1|Outcome|Sirolimus, Steroid Avoidance Arm|"Thymoglobulin induction, sirolimus and no maintenance corticosteroid.~Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid"
1224729|NCT00189202|O1|Outcome|Sirolimus, Steroid Avoidance Arm|"Thymoglobulin induction, sirolimus and no maintenance corticosteroid.~Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid"
1224730|NCT00189202|E1|Reported Event|Sirolimus, Steroid Avoidance Arm|"Thymoglobulin induction, sirolimus and no maintenance corticosteroid.~Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid"
1224731|NCT00189137|B3|Baseline|Total|Total of all reporting groups
1224732|NCT00189137|B2|Baseline|Gemcitabine and Docetaxel|"Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
1224733|NCT00189137|B1|Baseline|Doxorubicin and Ifosfamide|"Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
1224734|NCT00189137|P2|Participant Flow|Gemcitabine and Docetaxel|"Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
1224735|NCT00189137|P1|Participant Flow|Doxorubicin and Ifosfamide|"Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
1224757|NCT00189098|O2|Outcome|Placebo|The children in this group received placebo orally two times a day for 6 to 12 weeks.
1224736|NCT00189137|O2|Outcome|Gemcitabine and Docetaxel|"Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
1224843|NCT00187200|O2|Outcome|Sequential VV Pacing|V-V delay was optimized
1224737|NCT00189137|O1|Outcome|Doxorubicin and Ifosfamide|"Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
1224738|NCT00189137|O2|Outcome|Gemcitabine and Docetaxel|"Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
1224739|NCT00189137|O1|Outcome|Doxorubicin and Ifosfamide|"Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
1224740|NCT00189137|E2|Reported Event|Gemcitabine and Docetaxel|"Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
1224741|NCT00189137|E1|Reported Event|Doxorubicin and Ifosfamide|"Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
1224742|NCT00189098|B3|Baseline|Total|Total of all reporting groups
1224743|NCT00189098|B2|Baseline|Sulfamethoxazole-trimethoprim|Children assigned to the Sulfamethoxazole-trimethoprim group received Sulfamethoxazole-trimethoprim orally (18mg/kg two times a day) for 6 to 12 weeks. When at the first control visit after 6 weeks otorrhea was found to be present in either ear, the study medication was continued for another 6 weeks. The study medication was discontinued if both ears were found to be free from otorrhea and parents confirmed that they had seen no signs of otorrhea during the previous week. Parents were instructed to start the study medication again if symptoms of otorrhea recurred between the follow-up visits at 6 and 12 weeks. At inclusion and if otorrhea was present at 6 and 12 weeks follow-up, antibiotic with corticosteroid eardrops were prescribed in addition to the study medication for 7 to 10 days. After 12 weeks follow-up the study medication was discontinued irrespective of the presence or absence of otorrhea.
1224744|NCT00189098|B1|Baseline|Placebo|Children assigned to the placebo group received two times a day a placebo for 6 to 12 weeks. The placebo was a blinded suspension with an identical taste, bottle and fluid appearance as the sulfamethoxazole-trimethoprim suspension. When at the first control visit after 6 weeks otorrhea was found to be present in either ear, the study medication was continued for another 6 weeks. The study medication was discontinued if both ears were found to be free from otorrhea and parents confirmed that they had seen no signs of otorrhea during the previous week. Parents were instructed to start the study medication again if symptoms of otorrhea recurred between the follow-up visits at 6 and 12 weeks. At inclusion and if otorrhea was present at 6 and 12 weeks follow-up, antibiotic with corticosteroid eardrops were prescribed in addition to the study medication for 7 to 10 days. After 12 weeks follow-up the study medication was discontinued irrespective of the presence or absence of otorrhea.
1224745|NCT00189098|P2|Participant Flow|Sulfamethoxazole-trimethoprim|Children assigned to the Sulfamethoxazole-trimethoprim group received Sulfamethoxazole-trimethoprim orally (18mg/kg two times a day) for 6 to 12 weeks. When at the first control visit after 6 weeks otorrhea was found to be present in either ear, the study medication was continued for another 6 weeks. The study medication was discontinued if both ears were found to be free from otorrhea and parents confirmed that they had seen no signs of otorrhea during the previous week. Parents were instructed to start the study medication again if symptoms of otorrhea recurred between the follow-up visits at 6 and 12 weeks. At inclusion and if otorrhea was present at 6 and 12 weeks follow-up, antibiotic with corticosteroid eardrops were prescribed in addition to the study medication for 7 to 10 days. After 12 weeks follow-up the study medication was discontinued irrespective of the presence or absence of otorrhea.
1224746|NCT00189098|P1|Participant Flow|Placebo|Children assigned to the placebo group received two times a day a placebo for 6 to 12 weeks. The placebo was a blinded suspension with an identical taste, bottle and fluid appearance as the sulfamethoxazole-trimethoprim suspension. When at the first control visit after 6 weeks otorrhea was found to be present in either ear, the study medication was continued for another 6 weeks. The study medication was discontinued if both ears were found to be free from otorrhea and parents confirmed that they had seen no signs of otorrhea during the previous week. Parents were instructed to start the study medication again if symptoms of otorrhea recurred between the follow-up visits at 6 and 12 weeks. At inclusion and if otorrhea was present at 6 and 12 weeks follow-up, antibiotic with corticosteroid eardrops were prescribed in addition to the study medication for 7 to 10 days. After 12 weeks follow-up the study medication was discontinued irrespective of the presence or absence of otorrhea.
1224747|NCT00189098|O2|Outcome|Placebo|
1224748|NCT00189098|O1|Outcome|Sulfamethoxazole-trimethoprim|
1224749|NCT00189098|O2|Outcome|Placebo|
1224750|NCT00189098|O1|Outcome|Sulfamethoxazole-trimethoprim|
1224751|NCT00189098|O2|Outcome|Placebo|
1224752|NCT00189098|O1|Outcome|Sulfamethoxazole-trimethoprim|
1224753|NCT00189098|O2|Outcome|Placebo|
1224754|NCT00189098|O1|Outcome|Sulfamethoxazole-trimethoprim|
1224755|NCT00189098|O2|Outcome|Placebo|
1224756|NCT00189098|O1|Outcome|Sulfamethoxazole-trimethoprim|
1224758|NCT00189098|O1|Outcome|Sulfamethoxazole-trimethoprim|The children in this group received Sulfamethoxazole-trimethoprim orally (18 mg/kg, two times a day) for 6 to 12 weeks.
1224759|NCT00189098|E2|Reported Event|Placebo|
1224760|NCT00189098|E1|Reported Event|Sulfamethoxazole-trimethoprim|
1224761|NCT00187889|B3|Baseline|Total|Total of all reporting groups
1224762|NCT00187889|B2|Baseline|Placebo or Sugar Pill|Placebo blinded as 25 mg tablet once daily for 1 week then uptitrated to 2 pills daily for 15 weeks.
1224763|NCT00187889|B1|Baseline|Epleranone|Epleranone 25 mg daily for 1 week then uptitrated to 50 mg daily for 15 weeks.
1224764|NCT00187889|P2|Participant Flow|Placebo or Sugar Pill|Placebo blinded as 25 mg tablet once daily for 1 week then uptitrated to 2 pills daily for 15 weeks.
1224765|NCT00187889|P1|Participant Flow|Eplerenone|Eplerenone 25 mg (1 pill) daily for 1 week then uptitrated to 50 mg (2 pills) daily for 15 weeks.
1224766|NCT00187889|O2|Outcome|PLACEBO|Inert Placebo
1224767|NCT00187889|O1|Outcome|EPLERENONE|Active Drug
1224768|NCT00187889|O2|Outcome|PLACEBO|Inert Placebo
1224769|NCT00187889|O1|Outcome|EPLERINONE|Active drug
1224770|NCT00187889|E2|Reported Event|Placebo or Sugar Pill|Placebo blinded as 25 mg tablet once daily for 1 week then uptitrated to 2 pills daily for 15 weeks.
1224771|NCT00187889|E1|Reported Event|Epleranone|Epleranone 25 mg daily for 1 week then uptitrated to 50 mg daily for 15 weeks.
1224772|NCT00187876|B3|Baseline|Total|Total of all reporting groups
1224773|NCT00187876|B2|Baseline|ACL Biocleanse, Surgical|"The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.~ACL Biocleanse, surgical: The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process."
1224774|NCT00187876|B1|Baseline|ACL Reconstruction Control|"The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts.~ACL reconstruction control: The intervention consists of the reconstruction of the ACL ligament using aseptic patellar tendon allografts."
1224775|NCT00187876|P2|Participant Flow|ACL Biocleanse, Surgical|"The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.~ACL Biocleanse, surgical: The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process."
1224776|NCT00187876|P1|Participant Flow|ACL Reconstruction Control|"The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts.~ACL reconstruction control: The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts that are non- irradiated aseptically, processed BTB allografts."
1224777|NCT00187876|O2|Outcome|ACL Biocleanse, Surgical|"The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.~ACL Biocleanse, surgical: The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process."
1224778|NCT00187876|O1|Outcome|ACL Reconstruction Control|"The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts.~ACL reconstruction control: The intervention consists of the reconstruction of the ACL ligament using aseptic patellar tendon allografts."
1224779|NCT00187876|E2|Reported Event|ACL Biocleanse, Surgical|"The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.~ACL Biocleanse, surgical: The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process."
1224780|NCT00187876|E1|Reported Event|ACL Reconstruction Control|"The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts.~ACL reconstruction control: The intervention consists of the reconstruction of the ACL ligament using asceptic patellar tendon allografts."
1224781|NCT00187720|B3|Baseline|Total|Total of all reporting groups
1224782|NCT00187720|B2|Baseline|OCT2-variant Group|Subjects with OCT2-variant genotype will be given a single oral dose of 850 mg of metformin
1224783|NCT00187720|B1|Baseline|OCT2-reference Group|Subjects with OCT2-reference genotype will be given a single oral dose of 850 mg of metformin
1224784|NCT00187720|P2|Participant Flow|Organic Cation Transporter 2 (OCT2)-Reference Group|Subjects with OCT2-reference genotype will be given a single oral dose of 850 mg of metformin
1224785|NCT00187720|P1|Participant Flow|Organic Cation Transporter 2 (OCT2)-Variant Group|Subjects with OCT2-variant genotype will be given a single oral dose of 850 mg of metformin
1224786|NCT00187720|O2|Outcome|OCT2-reference Group|The renal clearance of metformin in subjects homozygous for the reference OCT2 genotype (808G/G) following a single oral dose of 850 mg of metformin.
1224787|NCT00187720|O1|Outcome|OCT2-variant Group|The renal clearance of metformin in subjects heterozygous for the variant OCT2 genotype (808G/T, *3D) following a single oral dose of 850 mg of metformin.
1224788|NCT00187720|E2|Reported Event|OCT2-variant Group|Subjects with OCT2-variant genotype will be given a single oral dose of 850 mg of metformin
1224789|NCT00187720|E1|Reported Event|OCT2-reference Group|Subjects with OCT2-reference genotype will be given a single oral dose of 850 mg of metformin
1224790|NCT00187681|B3|Baseline|Total|Total of all reporting groups
1224791|NCT00187681|B2|Baseline|OCT1-reference Group|Subjects with OCT1-reference alleles to be doses with 2 doses of Metformin (total 1850 mg).
1224792|NCT00187681|B1|Baseline|OCT1-variant Group|Subjects with OCT1-reference alleles to be doses with 2 doses of Metformin (total 1850 mg).
1224793|NCT00187681|P2|Participant Flow|Organic Cation Transporter 1 (OCT1)-Reference Group|Subjects with OCT1-reference alleles to be dosed with 2 doses of Metformin (total 1850 mg).
1224794|NCT00187681|P1|Participant Flow|Organic Cation Transporter 1 (OCT1)-Variant Group|Subjects with OCT1-variant alleles to be dosed with 2 doses of Metformin (total 1850 mg).
1224795|NCT00187681|O2|Outcome|OCT1-reference Group|Glucose lowering response to metformin (Glucose AUC) in subjects carrying the reference OCT1 genotype at all the four positions in the OCT1 gene.
1224796|NCT00187681|O1|Outcome|OCT1-variant Group|Glucose lowering response to metformin (Glucose AUC) in subjects carrying variant OCT1 genotypes (ie. carries at least one of four variant alleles OCT1-R61C, G401S, 420del, and/or OCT1-G465R).
1224797|NCT00187681|O2|Outcome|OCT1-reference Group|Metformin blood concentration-time profiles in subjects carrying the reference OCT1 allele at all the four positions in the OCT1 gene.
1224798|NCT00187681|O1|Outcome|OCT1-variant Group|Metformin blood concentration-time profiles in subjects carrying the variant OCT1 genotypes (ie. carries at least one of the four variant alleles OCT1-R61C, G401S, 420del, and/or OCT1-G465R).
1224799|NCT00187681|E2|Reported Event|OCT1-reference Group|Subjects with OCT1-reference alleles to be doses with 2 doses of Metformin (total 1850 mg).
1224800|NCT00187681|E1|Reported Event|OCT1-variant Group|Subjects with OCT1-reference alleles to be doses with 2 doses of Metformin (total 1850 mg).
1224801|NCT00187655|B1|Baseline|Cefotaxime|Cefotaxime will be administered as a single IV push of 2 grams over 5 minutes.
1224802|NCT00187655|P1|Participant Flow|Cefotaxime|Cefotaxime will be administered as a single IV push of 2 grams over 5 minutes.
1224803|NCT00187655|O2|Outcome|Homozygous for OAT3-Ile305Phe Variant|2 grams of Cefotaxime was administered as a single IV push of 2 grams over 5 minutes into healthy individuals that were identified as homozygous for the Ile305Phe variant and compared to volunteers that were heterozygous for the reference allele. Renal clearance and net secretory component of cefotaxime renal clearance (CLsec ) were analyzed.
1224804|NCT00187655|O1|Outcome|Heterozygous for the Ile305Phe Variant|2 grams of Cefotaxime was administered as a single IV push of 2 grams over 5 minutes into healthy individuals that were identified as heterozygous for the Ile305Phe variant and compared to volunteers that were homozygous for the reference allele. Renal clearance and net secretory component of cefotaxime renal clearance (CLsec ) were analyzed.
1224805|NCT00187655|E1|Reported Event|Cefotaxime|Cefotaxime will be administered as a single IV push of 2 grams over 5 minutes.
1224806|NCT00187486|B1|Baseline|Temodar Plus Tarceva Plus Radiotherapy|All patients were treated with radiotherapy and temozolomide; patients were treated with dosing of tarceva based upon use of enzyme-inducing antiepileptic drugs
1224807|NCT00187486|P1|Participant Flow|Temodar Plus Tarceva Plus Radiotherapy|All patients were treated with radiotherapy and temozolomide; patients were treated with dosing of tarceva based upon use of enzyme-inducing antiepileptic drugs
1224808|NCT00187486|O1|Outcome|Temodar Plus Tarceva Plus Radiotherapy|All patients were treated with radiotherapy and temozolomide; patients were treated with dosing of tarceva based upon use of enzyme-inducing antiepileptic drugs
1224809|NCT00187486|O1|Outcome|Temodar Plus Tarceva Plus Radiotherapy|All patients were treated with radiotherapy and temozolomide; patients were treated with dosing of tarceva based upon use of enzyme-inducing antiepileptic drugs
1224810|NCT00187486|E1|Reported Event|Temodar Plus Tarceva Plus Radiotherapy|All patients were treated with radiotherapy and temozolomide; patients were treated with dosing of tarceva based upon use of enzyme-inducing antiepileptic drugs
1224811|NCT00187226|B7|Baseline|Total|Total of all reporting groups
1224812|NCT00187226|B6|Baseline|2cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 2cm clinical target volume margin group.
1224813|NCT00187226|B5|Baseline|2cm Clinical Target Volume Margin - High-grade Glioma|Patients with High-grade glioma in the 2cm clinical target volume margin group.
1224814|NCT00187226|B4|Baseline|1cm Clinical Target Volume Margin - Other|Remaining patients in the 1cm clinical target volume margin group.
1224815|NCT00187226|B3|Baseline|1cm Clinical Target Volume Margin - Craniopharyngioma|Patients with Craniopharyngioma in the 1cm clinical target volume margin group.
1224816|NCT00187226|B2|Baseline|1cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 1cm clinical target volume margin group.
1224817|NCT00187226|B1|Baseline|1cm Clinical Target Volume Margin - Ependymoma|Patients with Ependymoma in the 1cm clinical target volume margin group.
1224818|NCT00187226|P6|Participant Flow|2cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 2cm clinical target volume margin group.
1224819|NCT00187226|P5|Participant Flow|2cm Clinical Target Volume Margin - High-grade Glioma|Patients with High-grade glioma in the 2cm clinical target volume margin group.
1224820|NCT00187226|P4|Participant Flow|1cm Clinical Target Volume Margin - Other|Remaining patients in the 1cm clinical target volume margin group.
1224821|NCT00187226|P3|Participant Flow|1cm Clinical Target Volume Margin - Craniopharyngioma|Patients with Craniopharyngioma in the 1cm clinical target volume margin group.
1224822|NCT00187226|P2|Participant Flow|1cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 1cm clinical target volume margin group.
1224823|NCT00187226|P1|Participant Flow|1cm Clinical Target Volume Margin - Ependymoma|Patients with Ependymoma in the 1cm clinical target volume margin group.
1224824|NCT00187226|O6|Outcome|2cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 2cm clinical target volume margin group.
1224825|NCT00187226|O5|Outcome|2cm Clinical Target Volume Margin - High-grade Glioma|Patients with High-grade glioma in the 2cm clinical target volume margin group.
1224826|NCT00187226|O4|Outcome|1cm Clinical Target Volume Margin - Other|Remaining patients in the 1cm clinical target volume margin group.
1224827|NCT00187226|O3|Outcome|1cm Clinical Target Volume Margin - Craniopharyngioma|Patients with Craniopharyngioma in the 1cm clinical target volume margin group.
1224828|NCT00187226|O2|Outcome|1cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 1cm clinical target volume margin group.
1224829|NCT00187226|O1|Outcome|1cm Clinical Target Volume Margin - Ependymoma|Patients with Ependymoma in the 1cm clinical target volume margin group.
1224830|NCT00187226|E6|Reported Event|2cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 2cm clinical target volume margin group.
1224831|NCT00187226|E5|Reported Event|2cm Clinical Target Volume Margin - High-grade Glioma|Patients with High-grade glioma in the 2cm clinical target volume margin group.
1224832|NCT00187226|E4|Reported Event|1cm Clinical Target Volume Margin - Other|Remaining patients in the 1cm clinical target volume margin group.
1224833|NCT00187226|E3|Reported Event|1cm Clinical Target Volume Margin - Craniopharyngioma|Patients with Craniopharyngioma in the 1cm clinical target volume margin group.
1224834|NCT00187226|E2|Reported Event|1cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 1cm clinical target volume margin group.
1224835|NCT00187226|E1|Reported Event|1cm Clinical Target Volume Margin - Ependymoma|Patients with Ependymoma in the 1cm clinical target volume margin group.
1224838|NCT00187200|B1|Baseline|Simultaneous Pacing V-V Timing|Patients maintained on simultaneous V-V delay
1224839|NCT00187200|P2|Participant Flow|Sequential VV Pacing|V-V delay was optimized
1224840|NCT00187200|P1|Participant Flow|Simultaneous Pacing V-V Timing|Patients maintained on simultaneous V-V delay
1224841|NCT00187200|O2|Outcome|Sequential VV Pacing|V-V delay was optimized
1224844|NCT00187200|O1|Outcome|Simultaneous Pacing V-V Timing|Patients maintained on simultaneous V-V delay
1224845|NCT00187200|O2|Outcome|Sequential VV Pacing|V-V delay was optimized
1224846|NCT00187200|O1|Outcome|Simultaneous Pacing V-V Timing|Patients maintained on simultaneous V-V delay
1224847|NCT00187200|O2|Outcome|Sequential VV Pacing|V-V delay was optimized per protocol
1224848|NCT00187200|O1|Outcome|Simultaneous Pacing V-V Timing|Patients maintained on simultaneous V-V delay per protocol
1224849|NCT00187200|E2|Reported Event|Sequential VV Pacing|V-V delay was optimized
1224850|NCT00187200|E1|Reported Event|Simultaneous Pacing V-V Timing|Patients maintained on simultaneous V-V delay
1224851|NCT00187135|B7|Baseline|Total|Total of all reporting groups
1224852|NCT00187135|B6|Baseline|Fentanyl 1/Placebo/Fentanyl 0.5|
1224853|NCT00187135|B5|Baseline|Fentanyl 1/Fentanyl 0.5/Placebo|
1224854|NCT00187135|B4|Baseline|Placebo/Fentanyl 1/Fentanyl 0.5|
1224855|NCT00187135|B3|Baseline|Placebo/Fentanyl 0.5/Fentanyl 1|
1224856|NCT00187135|B2|Baseline|Fentanyl 0.5/Fentanyl 1/Placebo|
1224857|NCT00187135|B1|Baseline|Fentanyl 0.5/Placebo/Fentanyl 1|
1224858|NCT00187135|P6|Participant Flow|Fentanyl 1 / Placebo /Fentanyl 0.5|Participants assigned to receive Fentanyl 1 micrograms per kilogram (mcg/kg) during their first visit Placebo during their second visit, and Fentanyl 0.5 micrograms per kilogram (mcg/kg) at the final visit.
1224859|NCT00187135|P5|Participant Flow|Fentanyl 1 / Fentanyl 0.5 / Placebo|Participants assigned to receive Fentanyl 1 micrograms per kilogram (mcg/kg) during their first visit Fentanyl 0.5 micrograms per kilogram (mcg/kg) during their second visit, and Placebo at the final visit.
1224860|NCT00187135|P4|Participant Flow|Placebo /Fentanyl 1 / Fentanyl 0.5|Participants assigned to receive Placebo during their first visit, Fentanyl 1 micrograms per kilogram (mcg/kg) during their second visit, and Fentanyl 0.5 micrograms per kilogram (mcg/kg) at the final visit.
1224861|NCT00187135|P3|Participant Flow|Placebo / Fentanyl 0.5 /Fentanyl 1|Participants assigned to receive Placebo during their first visit, Fentanyl 0.5 micrograms per kilogram (mcg/kg) during their second visit, and Fentanyl 1 micrograms per kilogram (mcg/kg) at the final visit.
1224862|NCT00187135|P2|Participant Flow|Fentanyl 0.5 /Fentanyl 1 / Placebo|Participants assigned to receive Fentanyl 0.5 micrograms per kilogram (mcg/kg) during their first visit, Fentanyl 1 micrograms per kilogram (mcg/kg) during their second visit, and Placebo at the final visit.
1224863|NCT00187135|P1|Participant Flow|Fentanyl 0.5 / Placebo / Fentanyl 1|Participants assigned to receive Fentanyl 0.5 micrograms per kilogram (mcg/kg) during their first visit, Placebo (Pl)during their second visit, and Fentanyl 1 micrograms per kilogram at the final visit.
1224864|NCT00187135|O3|Outcome|Placebo|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Placebo are included in this arm.
1224865|NCT00187135|O2|Outcome|Fentanyl 1mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 1mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
1224866|NCT00187135|O1|Outcome|Fentanyl 0.5mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 0.5 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
1224867|NCT00187135|O3|Outcome|Placebo|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Placebo are included in this arm.
1224868|NCT00187135|O2|Outcome|Fentanyl 1mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 1mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
1224869|NCT00187135|O1|Outcome|Fentanyl 0.5mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 0.5 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
1224870|NCT00187135|O3|Outcome|Placebo|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Placebo are included in this arm. Participants were included regardless of whether they received other treatments.
1224871|NCT00187135|O2|Outcome|Fentanyl 1mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 1mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
1224872|NCT00187135|O1|Outcome|Fentanyl 0.5mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 0.5 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
1224873|NCT00187135|O3|Outcome|Placebo|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Placebo are included in this arm. Participants were included regardless of whether they received other treatments.
1224874|NCT00187135|O2|Outcome|Fentanyl 1mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 1mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
1224875|NCT00187135|O1|Outcome|Fentanyl 0.5mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 0.5 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
1224876|NCT00187135|O1|Outcome|Fentanyl 0.5mcg/kg vs Fentanyl 1mcg/kg|Patients who completed treatment with Fentanyl 0.5 mcg/kg and Fentanyl 1mcg/kg.
1224877|NCT00187135|O2|Outcome|Fentanyl 0.5mcg/kg vs Placebo|Patients who completed treatment with Fentanyl 0.5 mcg/kg and placebo.
1224878|NCT00187135|O1|Outcome|Fentanyl 1mcg/kg vs Placebo|Patients who completed treatment with Fentanyl 1 mcg/kg and placebo.
1224879|NCT00187135|E3|Reported Event|Placebo|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Placebo are included in this arm. Participants were included regardless of whether they received other treatments.
1241327|NCT00117312|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
1224880|NCT00187135|E2|Reported Event|Fentanyl 1mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 1.0 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
1224881|NCT00187135|E1|Reported Event|Fentanyl 0.5mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 0.5 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
1224882|NCT00187096|B4|Baseline|Total|Total of all reporting groups
1224883|NCT00187096|B3|Baseline|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2.0 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
1224884|NCT00187096|B2|Baseline|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
1224885|NCT00187096|B1|Baseline|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Arm 1 participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
1224886|NCT00187096|P3|Participant Flow|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2.0 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
1224887|NCT00187096|P2|Participant Flow|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
1224888|NCT00187096|P1|Participant Flow|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|Participants with AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Arm 1 participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
1224889|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
1224890|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
1224891|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
1224892|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
1224893|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
1224894|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
1224895|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
1224934|NCT00186901|O1|Outcome|Apa 1 - AA Genotype|The AA genotype was observed in 68 (16.31%) out of 417 participants, with a median BMD Z score (a unit-less measure comparing to the age and gender matched national average) of -0.56.
1224935|NCT00186901|O4|Outcome|Supplement - (DXA)|53 of the 96 patients assessed at 36 months also had a DXA scan.
1224936|NCT00186901|O3|Outcome|Supplement - (QCT)|96 patients were assessed at 36 months using the QCT scan.
1224937|NCT00186901|O2|Outcome|Placebo - (DXA)|36 of the 84 patients assessed at 36 months also had a DXA scan.
1224939|NCT00186901|O4|Outcome|Supplement - (DXA)|51 of the 97 patients assessed at 24 months also had a DXA scan.
1224940|NCT00186901|O3|Outcome|Supplement - (QCT)|97 patients were assessed at 24 months using the QCT scan.
1224941|NCT00186901|O2|Outcome|Placebo - (DXA)|39 of the 91 patients assessed at 24 months also had a DXA scan.
1224942|NCT00186901|O1|Outcome|Placebo - (QCT)|91 patients were assessed at 24 months using the QCT scan.
1225857|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1224896|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
1224897|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
1224898|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
1224899|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
1224900|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
1224901|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
1224902|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
1224903|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
1224904|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
1224905|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
1224906|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
1224907|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
1224908|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
1224909|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
1224910|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
1224938|NCT00186901|O1|Outcome|Placebo - (QCT)|84 patients were assessed at 36 months using the QCT scan.
1224911|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
1224912|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
1224913|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
1224914|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
1224915|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
1224916|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
1224917|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
1224918|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
1224919|NCT00187096|E3|Reported Event|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
1224920|NCT00187096|E2|Reported Event|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
1224921|NCT00187096|E1|Reported Event|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
1224922|NCT00186901|B4|Baseline|Total|Total of all reporting groups
1224923|NCT00186901|B3|Baseline|Patients Ineligible for Randomization|424 patients were enrolled into the study, 149 were ineligible for randomization.
1224924|NCT00186901|B2|Baseline|Supplement Group|Nutritional counseling + supplementation with calcium, 1000mg/day + vitamin D, 800 units/day, for a 2 year period
1224925|NCT00186901|B1|Baseline|Placebo Group|Nutritional counseling + placebo
1224926|NCT00186901|P3|Participant Flow|Patients Ineligible for Randomization|424 patients were enrolled into the study, 149 were ineligible for randomization.
1224927|NCT00186901|P2|Participant Flow|Supplement Group|Nutritional counseling + supplementation with calcium, 1000mg/day + vitamin D, 800 units/day, for a 2 year period
1224928|NCT00186901|P1|Participant Flow|Placebo Group|Nutritional counseling + placebo
1224929|NCT00186901|O3|Outcome|Bsm - bb Genotype|The bb genotype was observed in 77 (18.47%) out of 417 participants, with a median BMD Z score of -0.17.
1224930|NCT00186901|O2|Outcome|Bsm - Bb Genotype|The Bb genotype was observed in 65 (15.59%) out of 417 participants, with a median BMD Z score of -0.17.
1224931|NCT00186901|O1|Outcome|Bsm - BB Genotype|The BB genotype was observed in 41 (09.83%) out of 417 participants, with a median BMD Z score (a unit-less measure comparing to the age and gender matched national average) of -0.5.
1224932|NCT00186901|O3|Outcome|Apa 1 - aa Genotype|The aa genotype was present in 49 (11.75%) out of 417 participants, with a median BMD Z score of -0.57.
1224933|NCT00186901|O2|Outcome|Apa 1 - Aa Genotype|The Aa genotype was observed in 104 (24.94%) out of 417 participants, with a median BMD Z score of -0.44.
1234350|NCT00140842|B3|Baseline|Total|Total of all reporting groups
1224943|NCT00186901|O4|Outcome|Supplement - (DXA)|47 of the 109 patients assessed at 12 months also had a DXA scan.
1224944|NCT00186901|O3|Outcome|Supplement - (QCT)|109 patients were assessed at 12 months using the QCT scan.
1224945|NCT00186901|O2|Outcome|Placebo - (DXA)|47 of the 109 patients assessed at 12 months also had a DXA scan.
1224946|NCT00186901|O1|Outcome|Placebo - (QCT)|109 patients were assessed at 12 months using the QCT scan.
1224947|NCT00186901|O4|Outcome|Supplement - (DXA)|61 of the 141 baseline patients also had a DXA scan.
1224948|NCT00186901|O3|Outcome|Supplement - (QCT)|141 patients were assessed at baseline using the QCT scan.
1224949|NCT00186901|O2|Outcome|Placebo - (DXA)|60 of the 134 baseline patients also had a DXA scan.
1224950|NCT00186901|O1|Outcome|Placebo - (QCT)|134 patients were assessed at baseline using the QCT scan.
1224951|NCT00186901|O4|Outcome|Above 22 Years|113 patients greater than 22 years of age were eligible for the study
1224952|NCT00186901|O3|Outcome|18 to 22 Years|74 patients between the ages of 18 and 22 were eligible for the study
1224953|NCT00186901|O2|Outcome|13 to 18 Years|139 patients between the ages of 13 and 18 were eligible for the study
1224954|NCT00186901|O1|Outcome|9 to 13 Years|98 patients between the ages of 9 and 13 were eligible for the study
1224955|NCT00186901|O2|Outcome|Non-white|59 non-white were eligible for the study
1224956|NCT00186901|O1|Outcome|White|365 white patients were eligible for the study
1224957|NCT00186901|O2|Outcome|Female|206 females were eligible for the study
1224958|NCT00186901|O1|Outcome|Male|218 males were eligible for the study
1224959|NCT00186901|O2|Outcome|Supplement|CVD Supplement Group (Experimental 1B): Patients who received calcium and vitamin D supplementation.
1224960|NCT00186901|O1|Outcome|Placebo|Placebo Group (Placebo Comparator 1A): Patients who received placebo pills.
1224961|NCT00186901|E3|Reported Event|Patients Ineligible for Randomization|424 patients were enrolled into the study, 149 were ineligible for randomization.
1224962|NCT00186901|E2|Reported Event|Supplement Group|Nutritional counseling + supplementation with calcium, 1000mg/day + vitamin D, 800 units/day, for a 2 year period
1224963|NCT00186901|E1|Reported Event|Placebo Group|Nutritional counseling + placebo
1224964|NCT00186888|B4|Baseline|Total|Total of all reporting groups
1224965|NCT00186888|B3|Baseline|Stratum C|Advanced Unilateral Retinoblastoma. Research participants with unilateral (unifocal or multifocal) advanced (Reese-Ellsworth group IV or V) intraocular disease will undergo upfront enucleation. Adjuvant therapy was also indicated in certain cases.
1224966|NCT00186888|B2|Baseline|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
1224967|NCT00186888|B1|Baseline|Stratum A|Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
1224968|NCT00186888|P3|Participant Flow|Stratum C|Advanced Unilateral Retinoblastoma. Research participants with unilateral (unifocal or multifocal) advanced (Reese-Ellsworth group IV or V) intraocular disease will undergo upfront enucleation. Adjuvant therapy was also indicated in certain cases.
1224969|NCT00186888|P2|Participant Flow|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
1224970|NCT00186888|P1|Participant Flow|Stratum A|Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
1224971|NCT00186888|O1|Outcome|5 Years|Participant age was 5 years ±3 months.
1224972|NCT00186888|O6|Outcome|5 Years|Participant age was 5 years ±3 months.
1224973|NCT00186888|O5|Outcome|3 Years|Participant age was 3 years ±3 months.
1224974|NCT00186888|O4|Outcome|2 Years|Participant age was 2 years ±3 months.
1224975|NCT00186888|O3|Outcome|1 Year|Participant age was 1 year ±3 months.
1224976|NCT00186888|O2|Outcome|6 Months|Participants at 6 months of age ±3 months.
1224977|NCT00186888|O1|Outcome|Baseline|At study entry.
1224978|NCT00186888|O6|Outcome|5 Years|Participant age was 5 years ±3 months.
1224979|NCT00186888|O5|Outcome|3 Years|Participant age was 3 years ±3 months.
1224980|NCT00186888|O4|Outcome|2 Years|Participant age was 2 years ±3 months.
1224981|NCT00186888|O3|Outcome|1 Year|Participant age was 1 year ±3 months.
1224982|NCT00186888|O2|Outcome|6 Months|Participants at 6 months of age ±3 months.
1224983|NCT00186888|O1|Outcome|Baseline|At study entry.
1224984|NCT00186888|O2|Outcome|Occupational Therapy Did Not Recommend Rehabilitation Services|Occupational therapy evaluation did not recommend rehabilitation services.
1224985|NCT00186888|O1|Outcome|Occupational Therapy Recommended Rehabilitation Services|Occupational therapy evaluation recommended rehabilitation services.
1224986|NCT00186888|O6|Outcome|5 Years|Participant age was 5 years ±3 months.
1224987|NCT00186888|O5|Outcome|3 Years|Participant age was 3 years ±3 months.
1224988|NCT00186888|O4|Outcome|2 Years|Participant age was 2 years ±3 months.
1224992|NCT00186888|O6|Outcome|5 Years|Participant age was 5 years ±3 months.
1224993|NCT00186888|O5|Outcome|3 Years|Participant age was 3 years ±3 months.
1224994|NCT00186888|O4|Outcome|2 Years|Participant age was 2 years ±3 months.
1224995|NCT00186888|O3|Outcome|1 Year|Participant age was 1 year ±3 months.
1224996|NCT00186888|O2|Outcome|6 Months|Participants at 6 months of age ±3 months.
1224998|NCT00186888|O4|Outcome|Stratum B-Advanced Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
1224999|NCT00186888|O3|Outcome|Stratum B-Early Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
1225000|NCT00186888|O2|Outcome|Stratum A-Advanced Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.~The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
1225001|NCT00186888|O1|Outcome|Stratum A-Early Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.~The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
1225002|NCT00186888|O4|Outcome|Stratum B-Advanced Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
1225003|NCT00186888|O3|Outcome|Stratum B-Early Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
1225004|NCT00186888|O2|Outcome|Stratum A-Advanced Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.~The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
1225005|NCT00186888|O1|Outcome|Stratum A-Early Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.~The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
1225006|NCT00186888|O4|Outcome|Stratum B-Advanced Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~The patients were re-classified into 2 groups of early (IC group=A and B) and advanced (IC group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
1225007|NCT00186888|O3|Outcome|Stratum B-Early Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~The patients were re-classified into 2 groups of early (IC group=A and B) and advanced (IC group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
1225041|NCT00186875|E1|Reported Event|Standard Risk|Participants with isolated extramedullary relapse (with blasts in bone marrow (BM) <5%) regardless of the timing of relapse, and participants with B-lineage ALL who develop a late hematological relapse (isolated BM or combined).
1225008|NCT00186888|O2|Outcome|Stratum A-Advanced Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.~The patients were re-classified into 2 groups of early (IC=A and B) and advanced (IC=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
1225009|NCT00186888|O1|Outcome|Stratum A-Early Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.~The patients were re-classified into 2 groups of early (IC group=A and B) and advanced (IC group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
1225010|NCT00186888|O4|Outcome|Stratum B-Advanced Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~The patients were re-classified into 2 groups of early (IC Group=A and B) and advanced (IC Group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
1225011|NCT00186888|O3|Outcome|Stratum B-Early Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~The patients were re-classified into 2 groups of early (IC Group=A and B) and advanced (IC Group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
1225012|NCT00186888|O2|Outcome|Stratum A-Advanced Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.~The patients were re-classified into 2 groups of early (IC Group=A and B) and advanced (IC Group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
1225013|NCT00186888|O1|Outcome|Stratum A-Early Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.~The patients were re-classified into 2 groups of early (IC Group=A and B) and advanced (IC Group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
1225014|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
1225015|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
1225016|NCT00186888|O1|Outcome|Stratum A|Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
1225017|NCT00186888|O1|Outcome|Stratum A|Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
1225018|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
1225019|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
1225020|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
1225021|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
1225042|NCT00186537|B4|Baseline|Total|Total of all reporting groups
1225022|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
1225046|NCT00186537|P3|Participant Flow|Calorie Restricted Diet|"calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks~Weight Loss"
1225023|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
1225024|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
1225025|NCT00186888|O1|Outcome|Stratum B|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~Two patients (3 eyes) in stratum B received external beam radiation therapy (EBRT), and the same 2 patients later required enucleation of the treated eye, thus the failure (event number) and censoring status were not changed for the 2 patients."
1225026|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
1225027|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
1225028|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
1225029|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
1225030|NCT00186888|E3|Reported Event|Stratum C|Advanced Unilateral Retinoblastoma. Research participants with unilateral (unifocal or multifocal) advanced (Reese-Ellsworth group IV or V) intraocular disease will undergo upfront enucleation. Adjuvant therapy was also indicated in certain cases.
1225031|NCT00186888|E2|Reported Event|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
1225032|NCT00186888|E1|Reported Event|Stratum A|Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
1225033|NCT00186875|B3|Baseline|Total|Total of all reporting groups
1225034|NCT00186875|B2|Baseline|High Risk|Participants with T-cell ALL who develop a hematological [isolated bone marrow (BM) or combined] relapse, irrespective of length of initial remission, participants with B-lineage ALL who develop early hematological relapse (isolated BM or combined), and participants relapsing after hematopoietic stem cell transplantation.
1225035|NCT00186875|B1|Baseline|Standard Risk|Participants with isolated extramedullary relapse (with blasts in bone marrow (BM) <5%) regardless of the timing of relapse, and participants with B-lineage ALL who develop a late hematological relapse (isolated BM or combined).
1225036|NCT00186875|P2|Participant Flow|High Risk|Participants with T-cell ALL who develop a hematological [isolated bone marrow (BM) or combined] relapse, irrespective of length of initial remission, participants with B-lineage ALL who develop early hematological relapse (isolated BM or combined), and participants relapsing after hematopoietic stem cell transplantation.
1225037|NCT00186875|P1|Participant Flow|Standard Risk|Participants with isolated extramedullary relapse (with blasts in bone marrow (BM) <5%) regardless of the timing of relapse, and participants with B-lineage ALL who develop a late hematological relapse (isolated BM or combined).
1225038|NCT00186875|O2|Outcome|High Risk|Participants with T-cell ALL who develop a hematological [isolated bone marrow (BM) or combined] relapse, irrespective of length of initial remission, participants with B-lineage ALL who develop early hematological relapse (isolated BM or combined), and participants relapsing after hematopoietic stem cell transplantation.
1225039|NCT00186875|O1|Outcome|Standard Risk|Participants with isolated extramedullary relapse (with blasts in bone marrow (BM) <5%) regardless of the timing of relapse, and participants with B-lineage ALL who develop a late hematological relapse (isolated BM or combined).
1225040|NCT00186875|E2|Reported Event|High Risk|Participants with T-cell ALL who develop a hematological [isolated bone marrow (BM) or combined] relapse, irrespective of length of initial remission, participants with B-lineage ALL who develop early hematological relapse (isolated BM or combined), and participants relapsing after hematopoietic stem cell transplantation.
1225562|NCT00183339|O2|Outcome|Fluoxetine|Participants treated with flexible dose fluoxetine solution
1225043|NCT00186537|B3|Baseline|Calorie Restricted Diet|"calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks~Weight Loss"
1225044|NCT00186537|B2|Baseline|Rosiglitazone|"4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks~Rosiglitazone"
1225045|NCT00186537|B1|Baseline|Fenofibrate|"160 mg daily for 12 weeks~Fenofibrate"
1225047|NCT00186537|P2|Participant Flow|Rosiglitazone|"4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks~Rosiglitazone"
1225048|NCT00186537|P1|Participant Flow|Fenofibrate|"160 mg daily for 12 weeks~Fenofibrate"
1225049|NCT00186537|O3|Outcome|Calorie Restricted Diet|"calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks~Weight Loss"
1225050|NCT00186537|O2|Outcome|Rosiglitazone|"4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks~Rosiglitazone"
1225051|NCT00186537|O1|Outcome|Fenofibrate|"160 mg daily for 12 weeks~Fenofibrate"
1225052|NCT00186537|O3|Outcome|Calorie Restricted Diet|"calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks~Weight Loss"
1225053|NCT00186537|O2|Outcome|Rosiglitazone|"4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks~Rosiglitazone"
1225054|NCT00186537|O1|Outcome|Fenofibrate|"160 mg daily for 12 weeks~Fenofibrate"
1225055|NCT00186537|O3|Outcome|Calorie Restricted Diet|"calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks~Weight Loss"
1225056|NCT00186537|O2|Outcome|Rosiglitazone|"4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks~Rosiglitazone"
1225057|NCT00186537|O1|Outcome|Fenofibrate|"160 mg daily for 12 weeks~Fenofibrate"
1225058|NCT00186537|E3|Reported Event|Calorie Restricted Diet|"calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks~Weight Loss"
1225059|NCT00186537|E2|Reported Event|Rosiglitazone|"4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks~Rosiglitazone"
1225060|NCT00186537|E1|Reported Event|Fenofibrate|"160 mg daily for 12 weeks~Fenofibrate"
1225061|NCT00186485|B1|Baseline|Right Sided Low Frequency Unilateral TMS|"Open treatment with 1Hz unilateral TMS delivered to the right DLPFC using the MagStim device~MagStim: The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain"
1225062|NCT00186485|P1|Participant Flow|Right Sided Low Frequency Unilateral TMS|"1Hz unilateral TMS delivered to the right DLPFC using the MagStim device~MagStim: The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain"
1225063|NCT00186485|O1|Outcome|Right Sided Low Frequency Unilateral TMS|"1Hz unilateral TMS delivered to the right DLPFC using the MagStim device~MagStim: The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain"
1225064|NCT00186485|O1|Outcome|Right Sided Low Frequency Unilateral TMS|"1Hz unilateral TMS delivered to the right DLPFC using the MagStim device~MagStim: The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain"
1225065|NCT00186485|O1|Outcome|Right Sided Low Frequency Unilateral TMS|"1Hz unilateral TMS delivered to the right DLPFC using the MagStim device~MagStim: The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain"
1225066|NCT00186485|E1|Reported Event|Right Sided Low Frequency Unilateral TMS|"Open treatment with 1Hz unilateral TMS delivered to the right DLPFC using the MagStim device~MagStim: The MagStim delivers low frequency 1Hz stimulation to the right frontal area of the brain"
1225067|NCT00186446|B1|Baseline|Bupropion and Smoking Cessation Behavioral Intervention|
1225068|NCT00186446|P1|Participant Flow|Bupropion and Smoking Cessation Behavioral Intervention|Medication for depression and behavioral intervention for smoking cessation
1225069|NCT00186446|O1|Outcome|Bupropion and Smoking Cessation Behavioral Intervention|bupropion and behavioral intervention
1225070|NCT00186446|O1|Outcome|Bupropion and Smoking Cessation Behavioral Intervention|Medication for depression and behavioral intervention for smoking cessation
1225071|NCT00186446|O1|Outcome|Bupropion and Smoking Cessation Behavioral Intervention|
1225072|NCT00186446|E1|Reported Event|Bupropion and Smoking Cessation Behavioral Intervention|
1225073|NCT00186186|B1|Baseline|Depakote ER|"Depakote ER up to 1500 mg/day~Depakote ER: Depakote ER"
1225074|NCT00186186|P1|Participant Flow|Depakote ER|Open-label. All subjects received Depakote extended release (ER) starting 250mg/daily at bedtime. Dose was increased every 4 days by 250mg/day as necessary and tolerated up to 1500 mg/day. All subjects took medication over a period of 7 weeks or terminated at the final visit (whichever came first).
1225075|NCT00186186|O1|Outcome|Depakote ER|Open-label. All subjects received Depakote extended release (ER) starting 250mg/daily at bedtime. Dose was increased every 4 days by 250mg/day as necessary and tolerated up to 1500 mg/day. All subjects took medication over a period of 7 weeks or terminated at the final visit (whichever came first).
1225076|NCT00186186|O1|Outcome|Depakote ER|Depakote ER up to 1500 mg/day
1225077|NCT00186186|E1|Reported Event|Depakote ER|Depakote ER up to 1500 mg/day
1225078|NCT00186069|B3|Baseline|Total|Total of all reporting groups
1225079|NCT00186069|B2|Baseline|Normal Saline|"Normal Saline 4 gram bolus, followed by 2 grams per hour~Normal Saline: Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion."
1225080|NCT00186069|B1|Baseline|Magnesium Sulfate|"Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour~Magnesium Sulfate: Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion."
1225081|NCT00186069|P2|Participant Flow|Normal Saline|"Normal Saline 4 gram bolus, followed by 2 grams per hour~Normal Saline: Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion."
1225082|NCT00186069|P1|Participant Flow|Magnesium Sulfate|"Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour~Magnesium Sulfate: Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion."
1225083|NCT00186069|O2|Outcome|Normal Saline|"Normal Saline 4 gram bolus, followed by 2 grams per hour~Normal Saline: Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion."
1225136|NCT00185588|B4|Baseline|Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
1225084|NCT00186069|O1|Outcome|Magnesium Sulfate|"Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour~Magnesium Sulfate: Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion."
1225165|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
1226020|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
1225085|NCT00186069|O2|Outcome|Normal Saline|"Normal Saline 4 gram bolus, followed by 2 grams per hour~Normal Saline: Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion."
1225086|NCT00186069|O1|Outcome|Magnesium Sulfate|"Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour~Magnesium Sulfate: Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion."
1225087|NCT00186069|O2|Outcome|Normal Saline|"Normal Saline 4 gram bolus, followed by 2 grams per hour~Normal Saline: Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion."
1225088|NCT00186069|O1|Outcome|Magnesium Sulfate|"Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour~Magnesium Sulfate: Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion."
1225089|NCT00186069|E2|Reported Event|Normal Saline|"Normal Saline 4 gram bolus, followed by 2 grams per hour~Normal Saline: Normal Saline infusion of 4 gram bolus, followed by 2 grams per hour with rate increases up to 4 grams per hour per physician discretion."
1225090|NCT00186069|E1|Reported Event|Magnesium Sulfate|"Magnesium Sulfate 4 gram bolus, followed by 2 grams per hour~Magnesium Sulfate: Magnesium Sulfate 4 gram bolus, followed by a maintenance dose at 2 grams per hour. Rate increases up to 4 grams per hour may be administered per physician discretion."
1225091|NCT00186056|B3|Baseline|Total|Total of all reporting groups
1225092|NCT00186056|B2|Baseline|Placebo|"Patients received placebo for 6 days~Mifepristone: Glucocorticoid antagonist"
1225093|NCT00186056|B1|Baseline|Mifepristone|"Patients received mifepristone for 6 days~Mifepristone: Glucocorticoid antagonist"
1225094|NCT00186056|P2|Participant Flow|Placebo|"Patients received placebo for 6 days~Mifepristone: Glucocorticoid antagonist"
1225095|NCT00186056|P1|Participant Flow|Mifepristone|"Patients received mifepristone for 6 days~Mifepristone: Glucocorticoid antagonist"
1225096|NCT00186056|O2|Outcome|Placebo|"Patients received placebo for 6 days~Mifepristone: Glucocorticoid antagonist"
1225097|NCT00186056|O1|Outcome|Mifepristone|"Patients received mifepristone for 6 days~Mifepristone: Glucocorticoid antagonist"
1225098|NCT00186056|E2|Reported Event|Placebo|"Patients received placebo for 6 days~Mifepristone: Glucocorticoid antagonist"
1225099|NCT00186056|E1|Reported Event|Mifepristone|"Patients received mifepristone for 6 days~Mifepristone: Glucocorticoid antagonist"
1225100|NCT00186017|B3|Baseline|Total|Total of all reporting groups
1225101|NCT00186017|B2|Baseline|Placebo|"Placebo~Olanzapine/Zyprexa"
1225102|NCT00186017|B1|Baseline|Olanzapine/Zyprexa|"Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week~Olanzapine/Zyprexa"
1225103|NCT00186017|P2|Participant Flow|Placebo|"Placebo~Olanzapine/Zyprexa"
1225104|NCT00186017|P1|Participant Flow|Olanzapine/Zyprexa|"Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week~Olanzapine/Zyprexa"
1225105|NCT00186017|O2|Outcome|Placebo|Placebo
1225106|NCT00186017|O1|Outcome|Olanzapine/Zyprexa|"Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week~Olanzapine/Zyprexa: Olanzapine was started at 2.5-10mg/day and adjusted by 2.5-5mg/day on a daily basis with a maximum dose of 20mg/day."
1225107|NCT00186017|O2|Outcome|Placebo|Placebo
1225108|NCT00186017|O1|Outcome|Olanzapine/Zyprexa|"Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week~Olanzapine/Zyprexa: Olanzapine was started at 2.5-10mg/day and adjusted by 2.5-5mg/day on a daily basis with a maximum dose of 20mg/day."
1225109|NCT00186017|O2|Outcome|Placebo|Placebo
1225110|NCT00186017|O1|Outcome|Olanzapine/Zyprexa|"Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week~Olanzapine/Zyprexa: Olanzapine was started at 2.5-10mg/day and adjusted by 2.5-5mg/day on a daily basis with a maximum dose of 20mg/day."
1225111|NCT00186017|O2|Outcome|Placebo|Placebo up to 8 per day for 1 week
1225112|NCT00186017|O1|Outcome|Olanzapine/Zyprexa|"Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week~Olanzapine/Zyprexa: Olanzapine was started at 2.5-10mg/day and adjusted by 2.5-5mg/day on a daily basis with a maximum dose of 20mg/day."
1225113|NCT00186017|E2|Reported Event|Placebo|Placebo taken in same manner as study drug up to 8 per day for 1 week
1225114|NCT00186017|E1|Reported Event|Olanzapine/Zyprexa|"Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week~Olanzapine/Zyprexa: Olanzapine was started at 2.5-10mg/day and adjusted by 2.5-5mg/day on a daily basis with a maximum dose of 20mg/day."
1225115|NCT00185965|B3|Baseline|Total|Total of all reporting groups
1225116|NCT00185965|B2|Baseline|Mycosis Fungoides (MF)|"Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment)~CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
1225117|NCT00185965|B1|Baseline|Lymphoma, B-cell Low-grade (BCL)|"Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure)~CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
1225118|NCT00185965|P2|Participant Flow|Mycosis Fungoides (MF)|"Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment)~CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
1225119|NCT00185965|P1|Participant Flow|Lymphoma, B-cell Low-grade (BCL)|"Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure)~CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
1225120|NCT00185965|O2|Outcome|Mycosis Fungoides (MF)|"Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment)~CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
1225137|NCT00185588|B3|Baseline|Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
1225121|NCT00185965|O1|Outcome|Lymphoma, B-cell Low-grade (BCL)|"Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure)~CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
1225122|NCT00185965|E2|Reported Event|Mycosis Fungoides (MF)|"Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment)~CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
1225123|NCT00185965|E1|Reported Event|Lymphoma, B-cell Low-grade (BCL)|"Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure)~CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
1225124|NCT00185692|B1|Baseline|Transplating of CD34+ Selected Hematopietic Cells|
1225125|NCT00185692|P1|Participant Flow|Transplating of CD34+ Selected Hematopietic Cells|
1225126|NCT00185692|O1|Outcome|Transplantation of CD34+ Cells|"Week #1: Total Lymphoid Inrradiation (TLI) 120 cGy + Anti-thymocyte Globulin (ATG) 1.5 mg/kg + Solumedrol 1.0 mg/kg Daily for 5 days.~Week #2: TLI 120 cGy (3 days a week, double on the 4th day) 5 days of CSP (oraly) one day after TLI was started. 3 days of MMF 4 days after TLI was started.~non-myeloablative hematopoietic cell transplantation: TLI and ATG infusion of the donor graft Post-transplant immunosuppression with cyclosporine and mycophenolate mofetil.~Anti-Thymocyte Globulin: 1.5 mg/kg QD x 5, IV. Dosage will be based on body weight.~Purified, sterile IgG fraction of immune serum of rabbits immumixied with human thymus lymphocyte. This drug acts to modify the number and function of lymphocytes.~Cyclosporine: 6.25 mg/kg BID, PO.Mechanism of action is inhibition of T-cell activation by binding to a cytoplasmic protein (cyclophillin).~Mycophenolate Mofetil: 15 mg/kg Q 8 hours, PO. Inhibtis the enzme inosine monophsophate dehydrogenase (MPDII) noncompetitively"
1225127|NCT00185692|O1|Outcome|Transplantation of CD34+ Cells|"Week #1: Total Lymphoid Inrradiation (TLI) 120 cGy + Anti-thymocyte Globulin (ATG) 1.5 mg/kg + Solumedrol 1.0 mg/kg Daily for 5 days.~Week #2: TLI 120 cGy (3 days a week, double on the 4th day) 5 days of CSP (oraly) one day after TLI was started. 3 days of MMF 4 days after TLI was started.~non-myeloablative hematopoietic cell transplantation: TLI and ATG infusion of the donor graft Post-transplant immunosuppression with cyclosporine and mycophenolate mofetil.~Anti-Thymocyte Globulin: 1.5 mg/kg QD x 5, IV. Dosage will be based on body weight.~Purified, sterile IgG fraction of immune serum of rabbits immumixied with human thymus lymphocyte. This drug acts to modify the number and function of lymphocytes.~Cyclosporine: 6.25 mg/kg BID, PO.Mechanism of action is inhibition of T-cell activation by binding to a cytoplasmic protein (cyclophillin).~Mycophenolate Mofetil: 15 mg/kg Q 8 hours, PO. Inhibtis the enzme inosine monophsophate dehydrogenase (MPDII) noncompetitively"
1225128|NCT00185692|E1|Reported Event|Transplating of CD34+ Selected Hematopietic Cells|
1225129|NCT00185679|B1|Baseline|Haploidentical Allogeneic Transplant Using CliniMACS System|"The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.~The CliniMACS System is a cell selection device consisting of the following components:~Computer-controlled instrument;~Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)~Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)~Wash buffer"
1225130|NCT00185679|P1|Participant Flow|Haploidentical Allogeneic Transplant Using CliniMACS System|"The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.~CliniMACS System: The CliniMACS System is a cell selection device consisting of the following components:~Computer-controlled instrument;~Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)~Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)~Wash buffer"
1225131|NCT00185679|O1|Outcome|Haploidentical Allogeneic Transplant Using CliniMACS System|"The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.~CliniMACS System: The CliniMACS System is a cell selection device consisting of the following components:~Computer-controlled instrument;~Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)~Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)~Wash buffer"
1225132|NCT00185679|O1|Outcome|Haploidentical Allogeneic Transplant Using CliniMACS System|"The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.~CliniMACS System: The CliniMACS System is a cell selection device consisting of the following components:~Computer-controlled instrument;~Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)~Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)~Wash buffer"
1225133|NCT00185679|O1|Outcome|Haploidentical Allogeneic Transplant Using CliniMACS System|"The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.~CliniMACS System: The CliniMACS System is a cell selection device consisting of the following components:~Computer-controlled instrument;~Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)~Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)~Wash buffer"
1225134|NCT00185679|E1|Reported Event|Haploidentical Allogeneic Transplant Using CliniMACS System|"The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.~CliniMACS System: The CliniMACS System is a cell selection device consisting of the following components:~Computer-controlled instrument;~Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)~Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)~Wash buffer"
1225135|NCT00185588|B5|Baseline|Total|Total of all reporting groups
1225563|NCT00183339|O1|Outcome|Placebo|participants who were treated with flexible dose placebo solution
1225138|NCT00185588|B2|Baseline|Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250|"Gemcitabine 850 mg/m2 + vatalanib 1250 mg~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
1225139|NCT00185588|B1|Baseline|Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250|"Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
1225140|NCT00185588|P4|Participant Flow|Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
1225141|NCT00185588|P3|Participant Flow|Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
1225142|NCT00185588|P2|Participant Flow|Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250|"Gemcitabine 850 mg/m2 + vatalanib 1250 mg~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
1225143|NCT00185588|P1|Participant Flow|Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250|"Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
1225144|NCT00185588|O4|Outcome|Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
1225145|NCT00185588|O3|Outcome|Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
1225146|NCT00185588|O2|Outcome|Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250|"Gemcitabine 850 mg/m2 + vatalanib 1250 mg~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
1225147|NCT00185588|O1|Outcome|Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250|"Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
1225148|NCT00185588|O4|Outcome|Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
1225149|NCT00185588|O3|Outcome|Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
1225150|NCT00185588|O2|Outcome|Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250|"Gemcitabine 850 mg/m2 + vatalanib 1250 mg~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
1225151|NCT00185588|O1|Outcome|Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250|"Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
1225152|NCT00185588|E4|Reported Event|Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
1225153|NCT00185588|E3|Reported Event|Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
1225154|NCT00185588|E2|Reported Event|Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250|"Gemcitabine 850 mg/m2 + vatalanib 1250 mg~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
1225155|NCT00185588|E1|Reported Event|Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250|"Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
1225156|NCT00185458|B1|Baseline|LNG IUS|Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.
1225157|NCT00185458|P1|Participant Flow|LNG IUS|Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.
1225158|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
1225159|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
1225160|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
1225161|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
1225162|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
1225163|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
1225164|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
1241328|NCT00117312|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
1225166|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
1225167|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
1225168|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
1225169|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
1225170|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
1225171|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
1225172|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
1225173|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
1225174|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
1225175|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
1225176|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
1225177|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
1225178|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
1225179|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
1225180|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
1225181|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
1225182|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
1225183|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
1225184|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
1225185|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
1225186|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
1225187|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
1225188|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
1225189|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
1225190|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
1225191|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
1225192|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
1225193|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
1225194|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
1225195|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
1225196|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
1225197|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
1225198|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
1225199|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
1225200|NCT00185458|O1|Outcome|LNG IUS|Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.
1225201|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
1225202|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
1225203|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
1225204|NCT00185458|O1|Outcome|LNG IUS|Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.
1225205|NCT00185458|O5|Outcome|Reference Period 4 (HRT Phase)|Patient assessment within day 271 to 360 of the HRT phase
1225206|NCT00185458|O4|Outcome|Reference Period 3 (HRT Phase)|Patient assessment within day 181 to 270 of the HRT phase
1225207|NCT00185458|O3|Outcome|Reference Period 2 (HRT Phase)|Patient assessment within day 91 to 180 of the HRT phase
1225208|NCT00185458|O2|Outcome|Reference Period 1 (HRT Phase)|Patient assessment within the first 90-days of the HRT phase
1225209|NCT00185458|O1|Outcome|Reference Period -1 (Contraception Phase)|Patient assessment within the last 90-days before starting the HRT
1241329|NCT00117312|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
1225210|NCT00185458|O5|Outcome|Reference Period 4 (HRT Phase)|Patient assessment within day 271 to 360 of the HRT phase
1225211|NCT00185458|O4|Outcome|Reference Period 3 (HRT Phase)|Patient assessment within day 181 to 270 of the HRT phase
1225212|NCT00185458|O3|Outcome|Reference Period 2 (HRT Phase)|Patient assessment within day 91 to 180 of the HRT phase
1225213|NCT00185458|O2|Outcome|Reference Period 1 (HRT Phase)|Patient assessment within the first 90-days of the HRT phase
1225214|NCT00185458|O1|Outcome|Reference Period -1 (Contraception Phase)|Patient assessment within the last 90-days before starting the HRT
1225215|NCT00185458|E1|Reported Event|LNG IUS|Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.
1225216|NCT00185380|B4|Baseline|Total|Total of all reporting groups
1225217|NCT00185380|B3|Baseline|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
1225218|NCT00185380|B2|Baseline|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
1225219|NCT00185380|B1|Baseline|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
1225220|NCT00185380|P3|Participant Flow|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
1225221|NCT00185380|P2|Participant Flow|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
1225222|NCT00185380|P1|Participant Flow|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
1225223|NCT00185380|O3|Outcome|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
1225224|NCT00185380|O2|Outcome|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
1225225|NCT00185380|O1|Outcome|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
1225226|NCT00185380|O3|Outcome|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
1225227|NCT00185380|O2|Outcome|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
1225228|NCT00185380|O1|Outcome|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
1225229|NCT00185380|O3|Outcome|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
1225230|NCT00185380|O2|Outcome|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
1225231|NCT00185380|O1|Outcome|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
1225232|NCT00185380|O3|Outcome|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
1225233|NCT00185380|O2|Outcome|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
1225234|NCT00185380|O1|Outcome|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
1225235|NCT00185380|O3|Outcome|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
1225236|NCT00185380|O2|Outcome|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
1225237|NCT00185380|O1|Outcome|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
1225238|NCT00185380|O3|Outcome|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
1225239|NCT00185380|O2|Outcome|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
1225240|NCT00185380|O1|Outcome|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
1225241|NCT00185380|O3|Outcome|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
1225242|NCT00185380|O2|Outcome|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
1225243|NCT00185380|O1|Outcome|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
1225244|NCT00185380|E3|Reported Event|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
1225245|NCT00185380|E2|Reported Event|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
1225246|NCT00185380|E1|Reported Event|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
1225247|NCT00185211|B3|Baseline|Total|Total of all reporting groups
1225248|NCT00185211|B2|Baseline|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
1225249|NCT00185211|B1|Baseline|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
1225250|NCT00185211|P2|Participant Flow|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
1225251|NCT00185211|P1|Participant Flow|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
1225252|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
1234522|NCT00139776|B3|Baseline|Total|Total of all reporting groups
1225253|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
1225254|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
1225255|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
1225256|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
1225257|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
1225258|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
1225259|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
1225260|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
1225261|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
1225262|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
1225263|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
1225264|NCT00185211|O1|Outcome|All Subjects|All subjects part of Intention-To-Treat (ITT) Population
1225265|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
1225266|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
1225267|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
1225268|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
1225269|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
1225270|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
1225271|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
1225272|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
1225273|NCT00185211|E2|Reported Event|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
1225274|NCT00185211|E1|Reported Event|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
1225275|NCT00184717|B4|Baseline|Total|Total of all reporting groups
1225276|NCT00184717|B3|Baseline|No Treatment|No somatropin (NN-220) treatment was given in the 52-week main period. Subjects was re-randomised to recive two dosing regimens (0.033 mg/kg/day or 0.067 mg/kg/day) in the 208-week extension period
1225277|NCT00184717|B2|Baseline|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
1225278|NCT00184717|B1|Baseline|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
1225279|NCT00184717|P5|Participant Flow|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
1225280|NCT00184717|P4|Participant Flow|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
1225281|NCT00184717|P3|Participant Flow|No Treatment|No somatropin (NN-220) treatment was given in the 52-week main period. Subjects was re-randomised to recive two dosing regimens (0.033 mg/kg/day or 0.067 mg/kg/day) in the 208-week extension period
1225282|NCT00184717|P2|Participant Flow|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
1225283|NCT00184717|P1|Participant Flow|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
1225564|NCT00183339|O2|Outcome|Fluoxetine|Participants will take liquid fluoxetine 2-20 mg
1225565|NCT00183339|O1|Outcome|Placebo|Participants will take the placebo
1225284|NCT00184717|O4|Outcome|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
1225285|NCT00184717|O3|Outcome|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
1225286|NCT00184717|O2|Outcome|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
1225287|NCT00184717|O1|Outcome|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
1225288|NCT00184717|O4|Outcome|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
1225289|NCT00184717|O3|Outcome|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
1225290|NCT00184717|O2|Outcome|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
1225291|NCT00184717|O1|Outcome|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
1225292|NCT00184717|O4|Outcome|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
1225293|NCT00184717|O3|Outcome|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
1225294|NCT00184717|O2|Outcome|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
1225295|NCT00184717|O1|Outcome|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
1225296|NCT00184717|O4|Outcome|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
1225297|NCT00184717|O3|Outcome|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
1225298|NCT00184717|O2|Outcome|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
1225299|NCT00184717|O1|Outcome|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
1225300|NCT00184717|O4|Outcome|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
1225301|NCT00184717|O3|Outcome|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
1225302|NCT00184717|O2|Outcome|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
1225303|NCT00184717|O1|Outcome|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
1225304|NCT00184717|O4|Outcome|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
1225305|NCT00184717|O3|Outcome|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
1225306|NCT00184717|O2|Outcome|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
1225307|NCT00184717|O1|Outcome|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
1225308|NCT00184717|O4|Outcome|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
1225309|NCT00184717|O3|Outcome|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
1225310|NCT00184717|O2|Outcome|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
1225311|NCT00184717|O1|Outcome|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
1225312|NCT00184717|O4|Outcome|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
1225313|NCT00184717|O3|Outcome|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
1225314|NCT00184717|O2|Outcome|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
1225315|NCT00184717|O1|Outcome|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
1225316|NCT00184717|E4|Reported Event|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
1225317|NCT00184717|E3|Reported Event|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
1225318|NCT00184717|E2|Reported Event|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
1225319|NCT00184717|E1|Reported Event|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
1225320|NCT00184600|B4|Baseline|Total|Total of all reporting groups
1225321|NCT00184600|B3|Baseline|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
1225322|NCT00184600|B2|Baseline|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
1225323|NCT00184600|B1|Baseline|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
1225324|NCT00184600|P3|Participant Flow|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
1225415|NCT00184548|E1|Reported Event|rFVIIa, Blunt Trauma|Three single doses of activated recombinant human factor VII (rFVIIa) (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
1225566|NCT00183339|E2|Reported Event|Fluoxetine|participants who were treated with flexible dose fluoxetine solution, 2-20mg per day
1225568|NCT00183274|B1|Baseline|Venlafaxine XR|"Venlafaxine XR flexible dose of 75 - 225 mg/d~Venlafaxine XR : All participants will take venlafaxine for 6 months. After this initial 6 months, participants who are not randomized to placebo will continue to take venlafaxine."
1225325|NCT00184600|P2|Participant Flow|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
1225326|NCT00184600|P1|Participant Flow|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
1225327|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
1225328|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
1225329|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
1225330|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
1225331|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
1225332|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
1225416|NCT00184054|B1|Baseline|Arsenic Trioxide (ATO) Plus Ascorbic Acid|All subjects received ATO 0.25 mg/kg/day intravenously for 25 days over a 35-day period and Ascorbic Acid 1000 mg/day intravenously every other day that ATO is given
1225567|NCT00183339|E1|Reported Event|Placebo|participants who were treated with flexible dose placebo solution
1225333|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
1225334|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
1225335|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
1225336|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
1225337|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
1225338|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
1225339|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
1225340|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
1225417|NCT00184054|P1|Participant Flow|Arsenic Trioxide (ATO) Plus Ascorbic Acid|All subjects received ATO 0.25 mg/kg/day intravenously for 25 days over a 35-day period and Ascorbic Acid 1000 mg/day intravenously every other day that ATO is given
1225418|NCT00184054|O1|Outcome|Arsenic Trioxide (ATO) Plus Ascorbic Acid|All subjects received ATO 0.25 mg/kg/day intravenously for 25 days over a 35-day period and Ascorbic Acid 1000 mg/day intravenously every other day that ATO is given
1225341|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
1225342|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
1225343|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
1225344|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
1225345|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
1225346|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
1225347|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
1225348|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
1225419|NCT00184054|O1|Outcome|Arsenic Trioxide (ATO) Plus Ascorbic Acid|All subjects received ATO 0.25 mg/kg/day intravenously for 25 days over a 35-day period and Ascorbic Acid 1000 mg/day intravenously every other day that ATO is given
1225855|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225349|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
1225350|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
1225351|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
1225352|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
1225353|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
1225354|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
1225355|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
1225356|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
1225420|NCT00184054|E1|Reported Event|Arsenic Trioxide (ATO) Plus Ascorbic Acid|All subjects received ATO 0.25 mg/kg/day intravenously for 25 days over a 35-day period and Ascorbic Acid 1000 mg/day intravenously every other day that ATO is given
1225680|NCT00182754|O1|Outcome|Arm I|Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously
1225357|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
1225358|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
1225359|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
1225360|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
1225361|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
1225362|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
1225363|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
1225364|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
1225421|NCT00184028|B1|Baseline|Taxotere Followed by Oxaliplatin|On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2. Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min. This treatment regimen will be repeated every 21 days.
1225681|NCT00182754|O2|Outcome|Arm II|Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
1225365|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
1225366|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
1225367|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
1225368|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
1225369|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
1225370|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
1225371|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
1225372|NCT00184600|E3|Reported Event|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
1225422|NCT00184028|P1|Participant Flow|Taxotere Followed by Oxaliplatin|On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2. Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min. This treatment regimen will be repeated every 21 days.
1225373|NCT00184600|E2|Reported Event|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
1225374|NCT00184600|E1|Reported Event|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
1225375|NCT00184548|B5|Baseline|Total|Total of all reporting groups
1225376|NCT00184548|B4|Baseline|Placebo, Penetrating Trauma|
1225377|NCT00184548|B3|Baseline|rFVIIa, Penetrating Trauma|
1225378|NCT00184548|B2|Baseline|Placebo, Blunt Trauma|
1225379|NCT00184548|B1|Baseline|rFVIIa, Blunt Trauma|
1225380|NCT00184548|P4|Participant Flow|Placebo, Penetrating Trauma|Three single doses of placebo (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
1225381|NCT00184548|P3|Participant Flow|rVIIa, Penetrating Trauma|Three single doses of activated recombinant human factor VII (rFVIIa) (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
1225382|NCT00184548|P2|Participant Flow|Placebo, Blunt Trauma|Three single doses of placebo (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
1225383|NCT00184548|P1|Participant Flow|rFVIIa, Blunt Trauma|Three single doses of activated recombinant human factor VII (rFVIIa) (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
1225384|NCT00184548|O4|Outcome|Placebo, Penetrating Trauma|
1225385|NCT00184548|O3|Outcome|rFVIIa, Penetrating Trauma|
1225386|NCT00184548|O2|Outcome|Placebo, Blunt Trauma|
1225387|NCT00184548|O1|Outcome|rFVIIa, Blunt Trauma|
1225388|NCT00184548|O4|Outcome|Placebo, Penetrating Trauma|
1225389|NCT00184548|O3|Outcome|rFVIIa, Penetrating Trauma|
1225390|NCT00184548|O2|Outcome|Placebo, Blunt Trauma|
1225391|NCT00184548|O1|Outcome|rFVIIa, Blunt Trauma|
1225392|NCT00184548|O4|Outcome|Placebo, Penetrating Trauma|
1225393|NCT00184548|O3|Outcome|rFVIIa, Penetrating Trauma|
1225394|NCT00184548|O2|Outcome|Placebo, Blunt Trauma|
1225395|NCT00184548|O1|Outcome|rFVIIa, Blunt Trauma|
1225396|NCT00184548|O4|Outcome|Placebo, Penetrating Trauma|
1225397|NCT00184548|O3|Outcome|rFVIIa, Penetrating Trauma|
1225398|NCT00184548|O2|Outcome|Placebo, Blunt Trauma|
1225399|NCT00184548|O1|Outcome|rFVIIa, Blunt Trauma|
1225400|NCT00184548|O4|Outcome|Placebo, Penetrating Trauma|
1225401|NCT00184548|O3|Outcome|rFVIIa, Penetrating Trauma|
1225402|NCT00184548|O2|Outcome|Placebo, Blunt Trauma|
1225403|NCT00184548|O1|Outcome|rFVIIa, Blunt Trauma|
1225404|NCT00184548|O4|Outcome|Placebo, Penetrating Trauma|
1225405|NCT00184548|O3|Outcome|rFVIIa, Penetrating Trauma|
1225406|NCT00184548|O2|Outcome|Placebo, Blunt Trauma|
1225407|NCT00184548|O1|Outcome|rFVIIa, Blunt Trauma|
1225408|NCT00184548|O4|Outcome|Placebo, Penetrating Trauma|
1225409|NCT00184548|O3|Outcome|rFVIIa, Penetrating Trauma|
1225410|NCT00184548|O2|Outcome|Placebo, Blunt Trauma|
1225411|NCT00184548|O1|Outcome|rFVIIa, Blunt Trauma|
1225412|NCT00184548|E4|Reported Event|Placebo, Penetrating Trauma|Three single doses of placebo (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
1225413|NCT00184548|E3|Reported Event|rVIIa, Penetrating Trauma|Three single doses of activated recombinant human factor VII (rFVIIa) (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
1225414|NCT00184548|E2|Reported Event|Placebo, Blunt Trauma|Three single doses of placebo (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
1225504|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
1225423|NCT00184028|O1|Outcome|Taxotere Followed by Oxaliplatin|On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2. Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min. This treatment regimen will be repeated every 21 days.
1225424|NCT00184028|O1|Outcome|Arm 1|Single arm study
1225425|NCT00184028|E1|Reported Event|Taxotere Followed by Oxaliplatin|On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2. Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min. This treatment regimen will be repeated every 21 days.
1225426|NCT00183963|B5|Baseline|Total|Total of all reporting groups
1225427|NCT00183963|B4|Baseline|Arm 4: High Dose Fulvestrant|
1225428|NCT00183963|B3|Baseline|Arm 3: Low Dose Fulvestrant|
1225429|NCT00183963|B2|Baseline|Arm 2: Tamoxifen Group|
1225430|NCT00183963|B1|Baseline|Arm 1: Control Group|
1225431|NCT00183963|P4|Participant Flow|Arm 4: High Dose Fulvestrant|"Fulvestrant 500mg~Fulvestrant : 500mg given on day 1, administered by IM Injection"
1225432|NCT00183963|P3|Participant Flow|Arm 3: Low Dose Fulvestrant|"Fulvestrant 250mg~Fulvestrant : 250mg given on day 1, administered by IM Injection"
1225433|NCT00183963|P2|Participant Flow|Arm 2: Tamoxifen Group|"Tamoxifen 20 mg~Tamoxifen : 20mg daily, by mouth x 21 days"
1225434|NCT00183963|P1|Participant Flow|Arm 1: Control Group|Placebo
1225435|NCT00183963|O4|Outcome|Arm 4: High Dose Fulvestrant|"Fulvestrant 500mg~Fulvestrant : 500mg given on day 1, administered by IM Injection"
1225436|NCT00183963|O3|Outcome|Arm 3: Low Dose Fulvestrant|"Fulvestrant 250mg~Fulvestrant : 250mg given on day 1, administered by IM Injection"
1225437|NCT00183963|O2|Outcome|Arm 2: Tamoxifen Group|"Tamoxifen 20 mg~Tamoxifen : 20mg daily, by mouth x 21 days"
1225438|NCT00183963|O1|Outcome|Arm 1: Control Group|Placebo
1225439|NCT00183963|O4|Outcome|Arm 4: High Dose Fulvestrant|500 mg given on day 1, administered by IM Injection
1225440|NCT00183963|O3|Outcome|Arm 3: Low Dose Fulvestrant|250 mg given on day 1, administered by IM Injection
1225441|NCT00183963|O2|Outcome|Arm 2: Tamoxifen Group|20 mg given by mouth daily for 21 days
1225442|NCT00183963|O1|Outcome|Arm 1: Control Group|Placebo
1225443|NCT00183963|E4|Reported Event|Arm 4: High Dose Fulvestrant|"Fulvestrant 500mg~Fulvestrant : 500mg given on day 1, administered by IM Injection"
1225444|NCT00183963|E3|Reported Event|Arm 3: Low Dose Fulvestrant|"Fulvestrant 250mg~Fulvestrant : 250mg given on day 1, administered by IM Injection"
1225445|NCT00183963|E2|Reported Event|Arm 2: Tamoxifen Group|"Tamoxifen 20 mg~Tamoxifen : 20mg daily, by mouth x 21 days"
1225446|NCT00183963|E1|Reported Event|Arm 1: Control Group|Placebo
1225447|NCT00183794|B1|Baseline|Gemcitabine and Docetaxel|Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
1225448|NCT00183794|P1|Participant Flow|Gemcitabine and Docetaxel|Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
1225449|NCT00183794|O1|Outcome|Gemcitabine and Docetaxel|Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
1225450|NCT00183794|O1|Outcome|Gemcitabine and Docetaxel|Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
1225451|NCT00183794|E1|Reported Event|Gemcitabine and Docetaxel|Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
1225452|NCT00183729|B3|Baseline|Total|Total of all reporting groups
1225453|NCT00183729|B2|Baseline|Placebo (2)|"Placebo for 12 weeks~Placebo: Placebo distribution is planned to mimic the active drug."
1225454|NCT00183729|B1|Baseline|Memantine (1)|"Memantine for 12 weeks~Memantine: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day."
1225455|NCT00183729|P2|Participant Flow|Placebo (2)|"Placebo for 12 weeks~Placebo: Placebo distribution is planned to mimic the active drug."
1225456|NCT00183729|P1|Participant Flow|Memantine (1)|"Memantine for 12 weeks~Memantine: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day."
1225457|NCT00183729|O2|Outcome|Placebo (2)|"Placebo for 12 weeks~Placebo: Placebo distribution is planned to mimic the active drug."
1225458|NCT00183729|O1|Outcome|Memantine (1)|"Memantine for 12 weeks~Memantine: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day."
1225459|NCT00183729|E2|Reported Event|Placebo (2)|"Placebo for 12 weeks~Placebo: Placebo distribution is planned to mimic the active drug."
1225460|NCT00183729|E1|Reported Event|Memantine (1)|"Memantine for 12 weeks~Memantine: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day."
1225461|NCT00183677|B1|Baseline|Open Label Escitalopram|Participants will receive treatment with escitalopram.
1225462|NCT00183677|P1|Participant Flow|Open Label Escitalopram|Participants will receive treatment with escitalopram.
1225463|NCT00183677|O1|Outcome|Open Label Escitalopram|Participants received open treatment with escitalopram.
1225464|NCT00183677|E1|Reported Event|Open Label Escitalopram|Participants will receive treatment with escitalopram.
1225465|NCT00183625|B3|Baseline|Total|Total of all reporting groups
1225466|NCT00183625|B2|Baseline|Olanzapine Treatment|
1225467|NCT00183625|B1|Baseline|Risperidone Treatment|
1225468|NCT00183625|P4|Participant Flow|Olanzapine + Supported Employment + Skills|Participants were randomized at baseline to risperidone or olanzapine and Individual Placement and Support with or without workplace fundamentals. The WIPS was not implemented until participant obtained a job.
1225469|NCT00183625|P3|Participant Flow|Risperidone + Supported Employment + Skills|Participants were randomized at baseline to risperidone or olanzapine and Individual Placement and Support with or without workplace fundamentals. The WIPS was not implemented until participant obtained a job.
1225561|NCT00183339|O1|Outcome|Placebo|participants who were treated with flexible dose placebo solution
1225470|NCT00183625|P2|Participant Flow|Olanzapine Plus Supported Employment|Individual Placement and Support plus Olanzapine. Participants were randomized at baseline to risperidone or olanzapine and Individual Placement and Support with or without workplace fundamentals. The WIPS was not implemented until participant obtained a job.
1225471|NCT00183625|P1|Participant Flow|Risperidone Plus Supported Employment|Participants were randomized at baseline to risperidone or olanzapine and Individual Placement and Support with or without workplace fundamentals. The WIPS was not implemented until participant obtained a job.
1225472|NCT00183625|O2|Outcome|Olanzapine Treatment|
1225473|NCT00183625|O1|Outcome|Risperidone Treatment|
1225474|NCT00183625|O2|Outcome|Individual Placement and Support With Workplace Fundamentals|Olanzapine and Risperidone Patients included.
1225475|NCT00183625|O1|Outcome|Individual Placement and Support (IPS)|IPS alone for risperidone and olanzapine subjects
1225476|NCT00183625|E2|Reported Event|Olanzapine Treatment|
1225477|NCT00183625|E1|Reported Event|Risperidone Treatment|
1225478|NCT00183469|B3|Baseline|Total|Total of all reporting groups
1225479|NCT00183469|B2|Baseline|Lamotrigine Plus Placebo Divalproex ER|
1225480|NCT00183469|B1|Baseline|Lamotrigine Plus Divalproex ER|Enrolled subjects received lamotrigine and divalproex ER
1225481|NCT00183469|P2|Participant Flow|Double-Blind Lamotrigine and Placebo Divalproex ER|Double-Blind randomized Participants will take active lamotrigine and placebo divalproex ER
1225482|NCT00183469|P1|Participant Flow|Double-Blind Lamotrigine and Divalproex ER|Double blind randomized participants will take active lamotrigine and active divalproex Er
1225483|NCT00183469|O2|Outcome|Double-Blind Lamotrigine and Placebo Divalproex ER|Double-Blind randomized Participants will take active lamotrigine and placebo divalproex ER
1225484|NCT00183469|O1|Outcome|Double-Blind Lamotrigine and Divalproex ER|Double blind randomized participants will take active lamotrigine and active divalproex Er
1225485|NCT00183469|E2|Reported Event|Lamotrigine Plus Placebo Divalproex ER|randomized subjects will take active lamotrigine and placebo divalproex ER
1225486|NCT00183469|E1|Reported Event|Lamotrigine Plus Active Divalproex ER|randomized participants will take active lamotrigine and active divalproex Er
1225487|NCT00183456|B5|Baseline|Total|Total of all reporting groups
1225488|NCT00183456|B4|Baseline|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
1225489|NCT00183456|B3|Baseline|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
1225490|NCT00183456|B2|Baseline|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
1225491|NCT00183456|B1|Baseline|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
1225492|NCT00183456|P4|Participant Flow|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
1225493|NCT00183456|P3|Participant Flow|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
1225494|NCT00183456|P2|Participant Flow|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
1225495|NCT00183456|P1|Participant Flow|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
1225496|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
1225497|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
1225498|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
1225499|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
1225500|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
1225501|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
1225502|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
1225503|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
1234681|NCT00138671|O2|Outcome|Subcutaneous Insulin|
1225505|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
1225506|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
1225507|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
1225508|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
1225509|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
1225510|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
1225511|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
1225512|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
1225513|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
1225514|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
1225515|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
1225516|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
1225517|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
1225518|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
1225519|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
1225520|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
1225521|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
1225522|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
1225523|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
1225524|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
1225525|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
1225526|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
1225527|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
1225528|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
1225529|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
1225530|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
1225531|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
1225532|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
1225533|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
1225534|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
1225535|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
1225536|NCT00183456|E4|Reported Event|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
1225537|NCT00183456|E3|Reported Event|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
1225538|NCT00183456|E2|Reported Event|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
1225539|NCT00183456|E1|Reported Event|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
1225540|NCT00183430|B3|Baseline|Total|Total of all reporting groups
1225541|NCT00183430|B2|Baseline|Placebo|"Participants will receive treatment with placebo plus psychotherapy~Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
1225542|NCT00183430|B1|Baseline|Prazosin|"Participants will receive treatment with prazosin plus psychotherapy~Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
1225543|NCT00183430|P2|Participant Flow|Placebo|"Participants will receive treatment with placebo plus psychotherapy~Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
1225544|NCT00183430|P1|Participant Flow|Prazosin|"Participants will receive treatment with prazosin plus psychotherapy~Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
1225545|NCT00183430|O2|Outcome|Placebo|"Participants will receive treatment with placebo plus psychotherapy~Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
1225546|NCT00183430|O1|Outcome|Prazosin|"Participants will receive treatment with prazosin plus psychotherapy~Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
1225547|NCT00183430|O2|Outcome|Placebo|"Participants will receive treatment with placebo plus psychotherapy~Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
1225548|NCT00183430|O1|Outcome|Prazosin|"Participants will receive treatment with prazosin plus psychotherapy~Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
1225549|NCT00183430|O2|Outcome|Placebo|"Participants will receive treatment with placebo plus psychotherapy~Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
1225550|NCT00183430|O1|Outcome|Prazosin|"Participants will receive treatment with prazosin plus psychotherapy~Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
1225551|NCT00183430|E2|Reported Event|Placebo|"Participants will receive treatment with placebo plus psychotherapy~Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
1225552|NCT00183430|E1|Reported Event|Prazosin|"Participants will receive treatment with prazosin plus psychotherapy~Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
1225553|NCT00183339|B3|Baseline|Total|Total of all reporting groups
1225554|NCT00183339|B2|Baseline|Fluoxetine|Participants will take liquid fluoxetine 2-20 mg
1225555|NCT00183339|B1|Baseline|Placebo|Participants will take the placebo
1225556|NCT00183339|P2|Participant Flow|Fluoxetine|Participants who received liquid fluoxetine 2-20 mg (of 4mg/1ml solution) in AM using a flexible dose strategy and planned 36 week titration schedule
1225557|NCT00183339|P1|Participant Flow|Placebo|Participants who received placebo solution between .5ml and 5.0ml
1225558|NCT00183339|O2|Outcome|Fluoxetine|Participants will take liquid fluoxetine 2-20 mg
1225559|NCT00183339|O1|Outcome|Placebo|Participants will take the placebo
1225560|NCT00183339|O2|Outcome|Fluoxetine|participants who were treated with flexible dose (2-20mg/D) fluoxetine solution
1225569|NCT00183274|P6|Participant Flow|Phase 3: Double-Blind Relapse Phase (Placebo After Placebo)|Patients administered placebo in Phase 2 continued to take placebo during Phase 3
1225570|NCT00183274|P5|Participant Flow|Phase 3: Double-Blind Relapse Phase (Placebo After Drug)|Patients administered venlafaxine XR in Phase 2 were given a placebo in Phase 3
1225571|NCT00183274|P4|Participant Flow|Phase 3: Double-Blind Relapse Phase (Drug After Drug)|Patients administered venlafaxine XR in phase 2 continued to take the drug during phase 3
1225572|NCT00183274|P3|Participant Flow|Phase 2: Double-Blind Placebo|Responders to 6 months of open-label venlafaxine XR treatment were randomized to double-blind treatment in a 60:40 ratio of drug to placebo
1225573|NCT00183274|P2|Participant Flow|Phase 2: Double-Blind Venlafaxine XR|Responders to 6 months of open-label venlafaxine XR treatment were randomized to double-blind treatment in 60:40 ratio of drug to placebo
1225574|NCT00183274|P1|Participant Flow|Phase 1: Open-Label|Patients received 75mg - 225 mg of open-label venlafaxine XR for 6 months.
1225575|NCT00183274|O6|Outcome|Placebo After Placebo|after receiving drug in phases 1 and placebo in phase 2, patients received placebo in phase 3
1225576|NCT00183274|O5|Outcome|Phase 3: Placebo After Drug|after receiving drug in phases 1 and 2, patients received placebo in phase 3
1225577|NCT00183274|O4|Outcome|Phase 3: Double-Blind Drug After Drug|after receiving drug in phases 1 and 2, patients continued to receive drug in phase 3
1225578|NCT00183274|O3|Outcome|Phase 2: Double-Blind Placebo|After receiving drug in Phase 1, patients began receiving placebo in phase 2
1225579|NCT00183274|O2|Outcome|Phase 2: Double-Blind Venlafaxine XR|after receiving drug in phase 1, patients continued to receive drug in phase 2
1225580|NCT00183274|O1|Outcome|Phase 1: Open-Label Venlafaxine XR|A 6-month administration of Venlafaxine XR that occurred between months 1 - 6 of study.
1225581|NCT00183274|O6|Outcome|Double-Blind Placebo After Placebo|A 6-month double-blind administration of placebo that occurred between months 13 - 18.
1225582|NCT00183274|O5|Outcome|Double-Blind Relapse Placebo After Drug|A 6-month double-blind administration of placebo that occurred between months 13 - 18.
1225583|NCT00183274|O4|Outcome|Double-Blind Relapse Drug After Drug|A 6-month double-blind administration of Venlafaxine XR that occurred between months 13 - 18.
1225584|NCT00183274|O3|Outcome|Double-Blind Placebo|A 6-month double-blind administration of placebo that occurred between months 7 - 12.
1225585|NCT00183274|O2|Outcome|Double-Blind Venlafaxine XR|A 6-month double-blind administration of Venlafaxine XR that occurred between months 7 - 12.
1225586|NCT00183274|O1|Outcome|Open-Label: Venlafaxine XR|A 6-month open label administration of flexible dose Venlafaxine XR that occurred between months 1 - 6 of study.
1225587|NCT00183274|E1|Reported Event|Venlafaxine XR|Adverse events were expected with venlafaxine XR. AEs were reported at least once by at least 5% of the study population for all patients who entered treatment. None of the adverse events that were expected or that occurred were considered serious or life threatening.
1225588|NCT00183248|B3|Baseline|Total|Total of all reporting groups
1225589|NCT00183248|B2|Baseline|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled ‘Detailed Description’ for additional treatment information.
1225590|NCT00183248|B1|Baseline|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled ‘Detailed Description’ for additional treatment information.
1225591|NCT00183248|P2|Participant Flow|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled ‘Detailed Description’ for additional treatment information.
1225592|NCT00183248|P1|Participant Flow|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled ‘Detailed Description’ for additional treatment information.
1225593|NCT00183248|O2|Outcome|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
1225594|NCT00183248|O1|Outcome|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
1225595|NCT00183248|O2|Outcome|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
1225596|NCT00183248|O1|Outcome|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
1234682|NCT00138671|O1|Outcome|Inhaled Insulin|
1225620|NCT00183196|E2|Reported Event|Naltrexone Plus Placebo and CBI|Naltrexone plus placebo and CBI individual counseling for 6 weeks then naltrexone and CBI counseling for 10 weeks.
1241330|NCT00117312|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
1225597|NCT00183248|O2|Outcome|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
1225598|NCT00183248|O1|Outcome|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
1225599|NCT00183248|O2|Outcome|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
1225600|NCT00183248|O1|Outcome|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
1225601|NCT00183248|O2|Outcome|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
1225602|NCT00183248|O1|Outcome|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
1225603|NCT00183248|O2|Outcome|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
1225604|NCT00183248|O1|Outcome|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
1225605|NCT00183248|O2|Outcome|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
1225606|NCT00183248|O1|Outcome|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
1225607|NCT00183248|E2|Reported Event|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled ‘Detailed Description’ for additional treatment information.
1225608|NCT00183248|E1|Reported Event|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled ‘Detailed Description’ for additional treatment information.
1225609|NCT00183196|B4|Baseline|Total|Total of all reporting groups
1225610|NCT00183196|B3|Baseline|Placebo Plus Placebo Plus CBI|Placebo plus placebo for 6 weeks and CBI individual counseling then placebo and CBI counseling for 10 additional weeks.
1225611|NCT00183196|B2|Baseline|Naltrexone Plus Placebo and CBI|Naltrexone plus placebo and CBI individual counseling for 6 weeks then naltrexone and CBI counseling for 10 weeks.
1225612|NCT00183196|B1|Baseline|Naltrexone Plus Gabapentin and CBI|Naltrexone plus gabapentin and CBI individual counseling for 6 weeks then naltrexone and CBI for 10 additional weeks.
1225613|NCT00183196|P3|Participant Flow|Placebo Plus Placebo Plus CBI|Placebo plus placebo for 6 weeks and CBI individual counseling then placebo and CBI counseling for 10 additional weeks.
1225614|NCT00183196|P2|Participant Flow|Naltrexone Plus Placebo and CBI|Naltrexone plus placebo and CBI individual counseling for 6 weeks then naltrexone and CBI counseling for 10 weeks.
1225615|NCT00183196|P1|Participant Flow|Naltrexone Plus Gabapentin and CBI|Naltrexone plus gabapentin and CBI individual counseling for 6 weeks then naltrexone and CBI for 10 additional weeks.
1225616|NCT00183196|O3|Outcome|Placebo Plus Placebo Plus CBI|Placebo plus placebo for 6 weeks and CBI individual counseling then placebo and CBI counseling for 10 additional weeks.
1225617|NCT00183196|O2|Outcome|Naltrexone Plus Placebo and CBI|Naltrexone plus placebo and CBI individual counseling for 6 weeks then naltrexone and CBI counseling for 10 weeks.
1225618|NCT00183196|O1|Outcome|Naltrexone Plus Gabapentin and CBI|Naltrexone plus gabapentin and CBI individual counseling for 6 weeks then naltrexone and CBI for 10 additional weeks.
1225619|NCT00183196|E3|Reported Event|Placebo Plus Placebo Plus CBI|Placebo plus placebo for 6 weeks and CBI individual counseling then placebo and CBI counseling for 10 additional weeks.
1225899|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225621|NCT00183196|E1|Reported Event|Naltrexone Plus Gabapentin and CBI|Naltrexone plus gabapentin and CBI individual counseling for 6 weeks then naltrexone and CBI for 10 additional weeks.
1225622|NCT00183092|B3|Baseline|Total|Total of all reporting groups
1225623|NCT00183092|B2|Baseline|Quinacrine|Quinacrine : 100mg by mouth three times a day
1225624|NCT00183092|B1|Baseline|Placebo|Placebo : 100mg by mouth three times a day
1225625|NCT00183092|P4|Participant Flow|Study Drug (Placebo) During Open-Label Period|Participants received Placebo during Double-Blind period and opted to continue study drug during Open-Label period
1225626|NCT00183092|P3|Participant Flow|Study Drug (Quinacrine) During Open-Label Period|Participants received Quinacrine during Double-Blind period and opted to continue study drug during Open-Label period
1225627|NCT00183092|P2|Participant Flow|Placebo|Double Blind Period: 100mg Placebo by mouth three times a day. Open Label Period: Choice of study drug or Quinacrine 100mg by mouth three times a day.
1225628|NCT00183092|P1|Participant Flow|Quinacrine|Double Blind Period: 100mg Quinacrine by mouth three times a day. Open Label Period: Choice of study drug or open-label Quinacrine 100mg by mouth three times a day.
1225629|NCT00183092|O2|Outcome|Quinacrine|Quinacrine : 100mg by mouth three times a day
1225630|NCT00183092|O1|Outcome|Placebo|Placebo : 100mg by mouth three times a day
1225631|NCT00183092|O2|Outcome|Quinacrine|Quinacrine : 100mg by mouth three times a day
1225632|NCT00183092|O1|Outcome|Placebo|Placebo : 100mg by mouth three times a day
1225633|NCT00183092|O2|Outcome|Quinacrine|Quinacrine : 100mg by mouth three times a day
1225634|NCT00183092|O1|Outcome|Placebo|Placebo : 100mg by mouth three times a day
1225635|NCT00183092|O2|Outcome|Quinacrine|Quinacrine : 100mg by mouth three times a day
1225636|NCT00183092|O1|Outcome|Placebo|Placebo : 100mg by mouth three times a day
1225637|NCT00183092|O2|Outcome|Quinacrine|Quinacrine : 100mg by mouth three times a day
1225638|NCT00183092|O1|Outcome|Placebo|Placebo : 100mg by mouth three times a day
1225639|NCT00183092|O2|Outcome|Quinacrine|Quinacrine : 100mg by mouth three times a day
1225640|NCT00183092|O1|Outcome|Placebo|Placebo : 100mg by mouth three times a day
1225641|NCT00183092|O2|Outcome|Quinacrine|Quinacrine : 100mg by mouth three times a day
1225642|NCT00183092|O1|Outcome|Placebo|Placebo : 100mg by mouth three times a day
1225643|NCT00183092|O2|Outcome|Quinacrine|Quinacrine : 100mg by mouth three times a day
1225644|NCT00183092|O1|Outcome|Placebo|Placebo : 100mg by mouth three times a day
1225645|NCT00183092|E3|Reported Event|Quinacrine Open-label|Quinacrine: Month 2 until death = optional open-label Quinacrine 100mg by mouth three times a day
1225646|NCT00183092|E2|Reported Event|Quinacrine Random Assignment|Quinacrine: 100mg by mouth three times a day. Baseline-Month 2 = random assignment (n=23), Month 2+ = optional continuation of assigned drug (n=1).
1225647|NCT00183092|E1|Reported Event|Placebo Random Assignment|Placebo : 100mg by mouth three times a day, Baseline-Month 2 = random assignment (n=28), Month 2+ = optional continuation of assigned drug (n=1).
1225648|NCT00182793|B1|Baseline|All Patients|Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®), one day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation, no more than 7 weeks later, patients proceed to course 2; OR Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.
1225649|NCT00182793|P1|Participant Flow|All Patients|Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®), one day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation, no more than 7 weeks later, patients proceed to course 2; OR Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.
1225650|NCT00182793|O1|Outcome|All Patients|Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®), one day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation, no more than 7 weeks later, patients proceed to course 2; OR Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.
1225651|NCT00182793|O1|Outcome|All Patients|Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®), one day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation, no more than 7 weeks later, patients proceed to course 2; OR Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.
1225682|NCT00182754|O1|Outcome|Arm I|Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously
1225683|NCT00182754|E2|Reported Event|Arm II|Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
1225684|NCT00182754|E1|Reported Event|Arm I|Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously
1225723|NCT00182091|O2|Outcome|AcroGHD Randomized to Placebo|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
1225777|NCT00181623|E1|Reported Event|Recombinant Human Prolactin Treatment|"Open label twice daily recombinant human prolactin~Recombinant Human Prolactin :"
1225652|NCT00182793|E1|Reported Event|All Patients|Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®), one day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation, no more than 7 weeks later, patients proceed to course 2; OR Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.
1225653|NCT00182767|B1|Baseline|Treatment (Ixabepilone and Doxorubicin)|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
1225654|NCT00182767|P5|Participant Flow|Ixabepilone: 16mg/m2 and Doxil 30 mg/m2: Level 5|"Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
1225655|NCT00182767|P4|Participant Flow|Ixabepilone: 13mg/m2 and Doxil 30 mg/m2: Level 4|"Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
1225656|NCT00182767|P3|Participant Flow|Ixabepilone: 40mg/m2 and Doxil 30 mg/m2: Level 3|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
1225657|NCT00182767|P2|Participant Flow|Ixabepilone: 32mg/m2 and Doxil 30 mg/m2: Level 2|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
1225658|NCT00182767|P1|Participant Flow|Ixabepilone: 24mg/m2 and Doxil 30 mg/m2: Level 1|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
1225659|NCT00182767|O1|Outcome|Treatment (Ixabepilone and Doxorubicin)|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
1225660|NCT00182767|O1|Outcome|Treatment (Ixabepilone and Doxorubicin)|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
1225661|NCT00182767|O1|Outcome|Treatment (Ixabepilone and Doxorubicin)|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
1225662|NCT00182767|O5|Outcome|Ixabepilone 16mg/m2 and Doxorubicin 30mg/m2: Level 5|"Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 28 days~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
1225663|NCT00182767|O4|Outcome|Ixabepilone 13mg/m2 and Doxorubicin 30mg/m2: Level 4|"Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 28 days~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
1225664|NCT00182767|O3|Outcome|Ixabepilone 40mg/m2 and Doxorubicin 30mg/m2: Level 3|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 21 days~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
1225665|NCT00182767|O2|Outcome|Ixabepilone 32mg/m2 and Doxorubicin 30mg/m2: Level 2|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 21 days~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
1225666|NCT00182767|O1|Outcome|Ixabepilone 24mg/m2 and Doxorubicin 30mg/m2: Level 1|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 21 days~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
1225667|NCT00182767|E5|Reported Event|Ixabepilone 16mg/m2 and Doxorubicin 30mg/m2: Level 5|"Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
1225668|NCT00182767|E4|Reported Event|Ixabepilone 13mg/m2 and Doxorubicin 30mg/m2: Level 4|"Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
1225669|NCT00182767|E3|Reported Event|Ixabepilone 40mg/m2 and Doxorubicin 30mg/m2: Level 3|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
1225670|NCT00182767|E2|Reported Event|Ixabepilone 32mg/m2 and Doxorubicin 30mg/m2: Level 2|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
1225671|NCT00182767|E1|Reported Event|Ixabepilone 24mg/m2 and Doxorubicin 30mg/m2: Level 1|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
1225672|NCT00182754|B3|Baseline|Total|Total of all reporting groups
1225673|NCT00182754|B2|Baseline|Arm II|Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
1225674|NCT00182754|B1|Baseline|Arm I|Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously
1225675|NCT00182754|P2|Participant Flow|Arm II|Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
1225676|NCT00182754|P1|Participant Flow|Arm I|Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously
1225677|NCT00182754|O2|Outcome|Arm II|Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
1225678|NCT00182754|O1|Outcome|Arm I|Patients receive 30 mg octreotide subcutaneously (SC) intramuscularly once on day 1. octreotide acetate: Given subcutaneously
1225679|NCT00182754|O2|Outcome|Arm II|Patients receive 2 milliliters placebo (0.9% sodium chloride) SC once on day 1. placebo: Given subcutaneously
1225685|NCT00182728|B1|Baseline|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.~surgery: conventional~therapy: neoadjuvant~radiation therapy: intraoperative radiation therapy"
1225686|NCT00182728|P1|Participant Flow|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.~surgery: conventional~therapy: neoadjuvant~radiation therapy: intraoperative radiation therapy"
1225687|NCT00182728|O1|Outcome|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.~surgery: conventional~therapy: neoadjuvant~radiation therapy: intraoperative radiation therapy"
1225688|NCT00182728|O1|Outcome|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.~surgery: conventional~therapy: neoadjuvant~radiation therapy: intraoperative radiation therapy"
1225689|NCT00182728|O1|Outcome|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.~surgery: conventional~therapy: neoadjuvant~radiation therapy: intraoperative radiation therapy"
1225690|NCT00182728|O1|Outcome|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.~surgery: conventional~therapy: neoadjuvant~radiation therapy: intraoperative radiation therapy"
1225691|NCT00182728|O1|Outcome|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.~surgery: conventional~therapy: neoadjuvant~radiation therapy: intraoperative radiation therapy"
1225692|NCT00182728|O1|Outcome|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.~surgery: conventional~therapy: neoadjuvant~radiation therapy: intraoperative radiation therapy"
1225693|NCT00182728|O1|Outcome|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.~surgery: conventional~therapy: neoadjuvant~radiation therapy: intraoperative radiation therapy"
1225694|NCT00182728|E1|Reported Event|Intraoperative Radiation Arm|"Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.~surgery: conventional~therapy: neoadjuvant~radiation therapy: intraoperative radiation therapy"
1225695|NCT00182689|B3|Baseline|Total|Total of all reporting groups
1225696|NCT00182689|B2|Baseline|Platinum-Refractory|Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or <=90 days after the last platinum treatment. All eligible patients who received treatment were included in baseline measures.
1225697|NCT00182689|B1|Baseline|Platinum-Sensitive|Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression >90 days after the last platinum treatment. All eligible patients who received treatment were included in baseline measures.
1225698|NCT00182689|P2|Participant Flow|Platinum-Refractory|Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or <=90 days after the last platinum treatment.
1225699|NCT00182689|P1|Participant Flow|Platinum-Sensitive|Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression >90 days after the last platinum treatment.
1225700|NCT00182689|O2|Outcome|Platinum-Refractory|Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or <=90 days after the last platinum treatment. All eligible patients who received treatment were included in baseline measures.
1225701|NCT00182689|O1|Outcome|Platinum-Sensitive|Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression >90 days after the last platinum treatment. All eligible patients who received treatment were included in baseline measures.
1225702|NCT00182689|O2|Outcome|Platinum-Refractory|Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or <=90 days after the last platinum treatment.
1225703|NCT00182689|O1|Outcome|Platinum-Sensitive|Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression >90 days after the last platinum treatment.
1225704|NCT00182689|O2|Outcome|Platinum Refractory|Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or <=90 days after the last platinum treatment.
1225705|NCT00182689|O1|Outcome|Platinum Sensitive|Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression >90 days after the last platinum treatment.
1225706|NCT00182689|E2|Reported Event|Platinum Refractory|
1225707|NCT00182689|E1|Reported Event|Platinum Sensitive|
1225708|NCT00182637|B1|Baseline|Bortezomib|administration of bortezomib
1225709|NCT00182637|P1|Participant Flow|Bortezomib|administration of bortezomib
1225710|NCT00182637|O1|Outcome|Bortezomib|administration of bortezomib
1225711|NCT00182637|O1|Outcome|Bortezomib|administration of bortezomib
1225712|NCT00182637|O1|Outcome|Bortezomib|bortezomib
1225713|NCT00182637|E1|Reported Event|Bortezomib|administration of bortezomib
1225714|NCT00182091|B5|Baseline|Total|Total of all reporting groups
1225715|NCT00182091|B4|Baseline|Active Acromegaly|Subjects with active acromegaly. This is not an interventional arm.
1225716|NCT00182091|B3|Baseline|AcroGHS|Subjects with a history of acromegaly who now have normal growth hormone levels. This is not an interventional arm.
1225717|NCT00182091|B2|Baseline|AcroGHD Randomized to Placebo|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
1225718|NCT00182091|B1|Baseline|AcroGHD Randomized to Growth Hormone|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
1225719|NCT00182091|P4|Participant Flow|Active Acromegaly|Subjects with active acromegaly. This is not an interventional arm.
1225720|NCT00182091|P3|Participant Flow|AcroGHS|Subjects with a history of acromegaly who now have normal growth hormone levels. This is not an interventional arm.
1225721|NCT00182091|P2|Participant Flow|AcroGHD Randomized to Placebo|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
1225722|NCT00182091|P1|Participant Flow|AcroGHD Randomized to Growth Hormone|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
1225776|NCT00181623|O1|Outcome|Recombinant Human Prolactin Treatment|"Open label twice daily recombinant human prolactin~Recombinant Human Prolactin :"
1225724|NCT00182091|O1|Outcome|AcroGHD Randomized to Growth Hormone|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
1225725|NCT00182091|O2|Outcome|AcroGHD Randomized to Placebo|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
1225726|NCT00182091|O1|Outcome|AcroGHD Randomized to Growth Hormone|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
1225727|NCT00182091|O2|Outcome|AcroGHD Randomized to Placebo|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
1225728|NCT00182091|O1|Outcome|AcroGHD Randomized to Growth Hormone|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
1225729|NCT00182091|O2|Outcome|AcroGHD Randomized to Placebo|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
1225730|NCT00182091|O1|Outcome|AcroGHD Randomized to Growth Hormone|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
1225731|NCT00182091|E4|Reported Event|Active Acromegaly|Subjects with active acromegaly. This is not an interventional arm.
1225732|NCT00182091|E3|Reported Event|AcroGHS|Subjects with a history of acromegaly who now have normal growth hormone levels. This is not an interventional arm.
1225733|NCT00182091|E2|Reported Event|AcroGHD Randomized to Placebo|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
1225734|NCT00182091|E1|Reported Event|AcroGHD Randomized to Growth Hormone|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
1225735|NCT00182078|B3|Baseline|Total|Total of all reporting groups
1225736|NCT00182078|B2|Baseline|Sertraline|Sertraline group received study medication every day for 12 weeks.
1225737|NCT00182078|B1|Baseline|Placebo|Placebo group who received no study medication.
1225738|NCT00182078|P2|Participant Flow|Sertraline - Received Study Medication|The drugs were administered for 24 weeks on a flexible fixed schedule beginning at 25mg per day, and increasing as high as 150 mg/day. Both groups received the assigned medication and dose over a 24-week period. At Week 12, the medication was tapered at a rate of 25mg every 3 days until it was discontinued.
1225739|NCT00182078|P1|Participant Flow|Placebo - Received Placebo|The placebo was administered for 24 weeks on a flexible fixed schedule beginning at 25mg per day, and increasing as high as 150 mg/day. Both groups received the assigned medication and dose over a 24-week period. At Week 12, the placebo was tapered at a rate of 25mg every 3 days until it was discontinued.
1225740|NCT00182078|O2|Outcome|Sertraline|Sertraline group received study medication every day for 12 weeks.
1225741|NCT00182078|O1|Outcome|Placebo|Placebo group who received no study medication.
1225742|NCT00182078|O2|Outcome|Sertraline|Sertraline group received study medication every day for 12 weeks.
1225743|NCT00182078|O1|Outcome|Placebo|Placebo group who received no study medication.
1225744|NCT00182078|O2|Outcome|Sertraline|Sertraline group received study medication every day for 12 weeks.
1225745|NCT00182078|O1|Outcome|Placebo|Placebo group who received no study medication.
1225746|NCT00182078|E2|Reported Event|Sertraline|Sertraline group received study medication every day for 12 weeks.
1225747|NCT00182078|E1|Reported Event|Placebo|Placebo group who received no study medication.
1225748|NCT00182000|B3|Baseline|Total|Total of all reporting groups
1225749|NCT00182000|B2|Baseline|Placebo|10 twice-weekly sessions of behavior therapy plus 100mg tablet of placebo
1225750|NCT00182000|B1|Baseline|Seromycin|10 twice-weekly sessions of behavior therapy plus 100mg tablet of seromycin
1225751|NCT00182000|P2|Participant Flow|Placebo|10 twice-weekly sessions of behavior therapy plus 100mg tablet of placebo
1225752|NCT00182000|P1|Participant Flow|Seromycin|10 twice-weekly sessions of behavior therapy plus 100mg tablet of seromycin
1225753|NCT00182000|O2|Outcome|Placebo|10 twice-weekly sessions of behavior therapy plus 100mg tablet of placebo
1225754|NCT00182000|O1|Outcome|Seromycin|10 twice-weekly sessions of behavior therapy plus 100mg tablet of seromycin
1225755|NCT00182000|E2|Reported Event|Placebo|10 twice-weekly sessions of behavior therapy plus 100mg tablet of placebo
1225756|NCT00182000|E1|Reported Event|Seromycin|10 twice-weekly sessions of behavior therapy plus 100mg tablet of seromycin
1225757|NCT00181883|B1|Baseline|Quetiapine|
1225758|NCT00181883|P1|Participant Flow|Quetiapine|
1225759|NCT00181883|O1|Outcome|Quetiapine|
1225760|NCT00181883|E1|Reported Event|Quetiapine|
1225761|NCT00181844|B1|Baseline|Lamotrigine|
1225762|NCT00181844|P1|Participant Flow|Lamotrigine|
1225763|NCT00181844|O1|Outcome|Lamotrigine|
1225764|NCT00181844|E1|Reported Event|Lamotrigine|
1225765|NCT00181766|B1|Baseline|Strattera (Atomoxetine)|Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
1225766|NCT00181766|P1|Participant Flow|Strattera (Atomoxetine)|Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
1225767|NCT00181766|O1|Outcome|Strattera (Atomoxetine)|Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
1225768|NCT00181766|O1|Outcome|Strattera (Atomoxetine)|Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
1225769|NCT00181766|E1|Reported Event|Strattera (Atomoxetine)|Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
1225770|NCT00181714|B1|Baseline|OROS-Methylphenidate|Youth ages 12-17 years with DSM-IV ADHD, treated with open-label OROS-MPH.
1225771|NCT00181714|P1|Participant Flow|OROS-Methylphenidate|Youth ages 12-17 years with DSM-IV ADHD, treated with open-label OROS-MPH.
1225772|NCT00181714|O1|Outcome|OROS-Methylphenidate|
1225773|NCT00181714|E1|Reported Event|OROS-Methylphenidate|Youth ages 12-17 years with DSM-IV ADHD, treated with open-label OROS-MPH.
1225774|NCT00181623|B1|Baseline|Recombinant Human Prolactin Treatment|"Open label twice daily recombinant human prolactin~Recombinant Human Prolactin :"
1225775|NCT00181623|P1|Participant Flow|Recombinant Human Prolactin Treatment|"Open label twice daily recombinant human prolactin 60 mcg/kg~Recombinant Human Prolactin :"
1225779|NCT00181610|B3|Baseline|Recombinant Human Prolactin Once Per Day|"Recombinant human prolactin alternating with placebo every 12 hours~Recombinant human prolactin : 60 mcg/kg given every 12 hours or every 24 hours"
1225780|NCT00181610|B2|Baseline|Recombinant Human Prolactin Twice Per Day|"Recombinant human prolactin every 12 hours~Recombinant Human Prolactin : 60 mcg/kg every 12 hours"
1225781|NCT00181610|B1|Baseline|Placebo Twice Per Day|"Placebo group~Normal Saline : twice per day"
1225782|NCT00181610|P3|Participant Flow|Recombinant Human Prolactin Alternating With Placebo|"Recombinant human prolactin alternating with placebo every 12 hours~Recombinant human prolactin : 60 mcg/kg given every 24 hours alternating with normal saline placebo given once every 24 hours"
1225783|NCT00181610|P2|Participant Flow|Recombinant Human Prolactin Twice Per Day|"Recombinant human prolactin every 12 hours~Recombinant Human Prolactin : 60 mcg/kg every 12 hours"
1225784|NCT00181610|P1|Participant Flow|Placebo Twice Per Day|"Placebo group~Normal Saline : twice per day"
1225785|NCT00181610|O3|Outcome|Recombinant Human Prolactin Alternating With Placebo|"Recombinant human prolactin alternating with placebo every 12 hours~Recombinant human prolactin : 60 mcg/kg given every 24 hours Placebo given every 24 hours"
1225786|NCT00181610|O2|Outcome|Recombinant Human Prolactin Twice Per Day|"Recombinant human prolactin every 12 hours~Recombinant Human Prolactin : 60 mcg/kg every 12 hours"
1225787|NCT00181610|O1|Outcome|Placebo Twice Per Day|"Placebo group~Normal Saline : twice per day"
1225788|NCT00181610|E3|Reported Event|Recombinant Human Prolactin Once Per Day|"Recombinant human prolactin alternating with placebo every 12 hours~Recombinant human prolactin : 60 mcg/kg given every 12 hours or every 24 hours"
1225789|NCT00181610|E2|Reported Event|Recombinant Human Prolactin Twice Per Day|"Recombinant human prolactin every 12 hours~Recombinant Human Prolactin : 60 mcg/kg every 12 hours"
1225790|NCT00181610|E1|Reported Event|Placebo Twice Per Day|"Placebo group~Normal Saline : twice per day"
1225791|NCT00181155|B1|Baseline|Intravenous Allopurinol|We randomized patients with nonischemic cardiomyopathy in a double-blind fashion to allopurinol (300 mg intravenously) or placebo infusion, 4-to-1, the latter for purposes of blinding only. The myocardial concentrations of ATP and creatine phosphate (PCr) and the rate of adenosine triphosphate (ATP) synthesis through CK (CK flux) were determined by 31-Phosphorus (31P) magnetic resonance spectroscopy.
1225792|NCT00181155|P2|Participant Flow|Placebo|Each participant underwent magnetic resonance spectroscopy before and following infusion of either allopurinol 300mg or placebo.
1225793|NCT00181155|P1|Participant Flow|Allopurinol|Each participant underwent magnetic resonance spectroscopy before and following infusion of either allopurinol 300mg or placebo.
1225794|NCT00181155|O1|Outcome|Intravenous Allopurinol|Infused Aloprim 300 mg in 50cc of 5% dextrose. Post infusion MRS data acquired on each subject.
1225795|NCT00181155|O1|Outcome|Intravenous Allopurinol|Infused Aloprim 300 mg in 50cc 5% dextrose. Post MRS data acquired on each subject.
1225796|NCT00181155|O1|Outcome|Baseline|Each participant underwent baseline MRS imaging prior to infusion of Aloprim 300 mg in 50 cc of 5% Dextrose.
1225797|NCT00181155|O1|Outcome|Baseline|Each participant underwent baseline MRS imaging prior to infusion of Aloprim 300 mg in 50 cc of 5% Dextrose.
1225798|NCT00181155|E2|Reported Event|Arm 2 - Placebo|Each participant received pre and post MRS images following infusion of 50 cc of 5% Dextrose (equivalent volume to active treatment arm).
1225799|NCT00181155|E1|Reported Event|Arm 1 - Intravenous Allopurinol|Each participant received pre and post MRS images following infusion of 50 cc of Aloprim 300mg in 5% Dextrose.
1225800|NCT00180687|B5|Baseline|Total|Total of all reporting groups
1225801|NCT00180687|B4|Baseline|Injected Bupivacaine Intraperitoneally|"Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)~Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity"
1225802|NCT00180687|B3|Baseline|Nebulised Bupivacaine Intraperitoneally|"Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)~Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)"
1225803|NCT00180687|B2|Baseline|IP Aerosolized Normal Saline|"Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)~Normal Saline: Nebulised Normal Saline"
1225804|NCT00180687|B1|Baseline|Control|"No intraperitoneal therapeutics (No nebulised Bupivacaine)~No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given"
1225805|NCT00180687|P4|Participant Flow|Injected Bupivacaine Intraperitoneally|"Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)~Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity"
1225806|NCT00180687|P3|Participant Flow|Nebulised Bupivacaine Intraperitoneally|"Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)~Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)"
1225807|NCT00180687|P2|Participant Flow|IP Aerosolized Normal Saline|"Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)~Normal Saline: Nebulised Normal Saline"
1225808|NCT00180687|P1|Participant Flow|Control|"No intraperitoneal therapeutics (No nebulised Bupivacaine)~No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given"
1225809|NCT00180687|O4|Outcome|Injected Bupivacaine Intraperitoneally|"Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)~Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity"
1225810|NCT00180687|O3|Outcome|Nebulised Bupivacaine Intraperitoneally|"Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)~Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)"
1225811|NCT00180687|O2|Outcome|IP Aerosolized Normal Saline|"Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)~Normal Saline: Nebulised Normal Saline"
1225812|NCT00180687|O1|Outcome|Control|"No intraperitoneal therapeutics (No nebulised Bupivacaine)~No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given"
1225813|NCT00180687|O4|Outcome|Injected Bupivacaine Intraperitoneally|"Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)~Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity"
1225814|NCT00180687|O3|Outcome|Nebulised Bupivacaine Intraperitoneally|"Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)~Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)"
1225815|NCT00180687|O2|Outcome|IP Aerosolized Normal Saline|"Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)~Normal Saline: Nebulised Normal Saline"
1225816|NCT00180687|O1|Outcome|Control|"No intraperitoneal therapeutics (No nebulised Bupivacaine)~No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given"
1225817|NCT00180687|O4|Outcome|Injected Bupivacaine Intraperitoneally|"Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)~Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity"
1225818|NCT00180687|O3|Outcome|Nebulised Bupivacaine Intraperitoneally|"Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)~Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)"
1225819|NCT00180687|O2|Outcome|IP Aerosolized Normal Saline|"Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)~Normal Saline: Nebulised Normal Saline"
1225820|NCT00180687|O1|Outcome|Control|"No intraperitoneal therapeutics (No nebulised Bupivacaine)~No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given"
1225821|NCT00180687|O4|Outcome|Injected Bupivacaine Intraperitoneally|"Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)~Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity"
1225822|NCT00180687|O3|Outcome|Nebulised Bupivacaine Intraperitoneally|"Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)~Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)"
1225823|NCT00180687|O2|Outcome|IP Aerosolized Normal Saline|"Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)~Normal Saline: Nebulised Normal Saline"
1225824|NCT00180687|O1|Outcome|Control|"No intraperitoneal therapeutics (No nebulised Bupivacaine)~No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given"
1225825|NCT00180687|E4|Reported Event|Injected Bupivacaine Intraperitoneally|"Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)~Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity"
1225826|NCT00180687|E3|Reported Event|Nebulised Bupivacaine Intraperitoneally|"Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)~Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)"
1225827|NCT00180687|E2|Reported Event|IP Aerosolized Normal Saline|"Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)~Normal Saline: Nebulised Normal Saline"
1225828|NCT00180687|E1|Reported Event|Control|"No intraperitoneal therapeutics (No nebulised Bupivacaine)~No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given"
1225829|NCT00180479|B3|Baseline|Total|Total of all reporting groups
1225830|NCT00180479|B2|Baseline|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225831|NCT00180479|B1|Baseline|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225832|NCT00180479|P2|Participant Flow|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225833|NCT00180479|P1|Participant Flow|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225834|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225835|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225836|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225837|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225838|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225839|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225840|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225841|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225842|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225843|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225844|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225845|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225846|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225847|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225848|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225849|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225850|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225851|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225852|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225853|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225854|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225856|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225858|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225859|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225860|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225861|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225862|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225863|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225864|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225865|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225866|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225867|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225868|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225869|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225870|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225871|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225872|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225873|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225874|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225875|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225876|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225877|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225878|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225879|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225880|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225881|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225882|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225883|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225884|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225885|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225886|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225887|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225888|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225889|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225890|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225891|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225892|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225893|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225894|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225895|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225896|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225897|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225898|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225900|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225901|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225902|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225903|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225904|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225905|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225906|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225907|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225908|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225909|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225910|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225911|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225912|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225913|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225914|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225915|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225916|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225917|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225918|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225919|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225920|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225921|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225922|NCT00180479|E2|Reported Event|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
1225923|NCT00180479|E1|Reported Event|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
1225924|NCT00180323|B1|Baseline|Group 1|
1225925|NCT00180323|P1|Participant Flow|Group 1|
1225926|NCT00180323|O1|Outcome|Cardiac Resynchronization Therapy ICD (Renewal CRT)|Velocity time integral will be measured at implant (baseline), 3 months and 6 months Follow-up. Measurements will be taken at each timepoint at intrinsic heart rate and 10, 20 and 30 Bpm above intrinsic heart rate (paced rhythm)
1225927|NCT00180323|O1|Outcome|Cardiac Resynchronization Therapy ICD (Renewal CRT)|6 minute walktest (6 MWT) was performed before implant (baseline ), 3months and 6 months Follow-up.
1225928|NCT00180323|O1|Outcome|Cardiac Resynchronization Therapy ICD (Renewal CRT)|Optimal AV-Delay will be measured at implant (baseline ), 3months and 6 months Follow-up for intrinsic heart rate, and 10, 20 and 30 Bpm above intrinsic heart rate.
1225929|NCT00180323|O1|Outcome|Cardiac Resynchronization Therapy ICD (Renewal CRT)|Velocity time integral will be measured at implant (baseline), 3 months and 6 months Follow-up. Measurements will be taken at each timepoint at intrinsic heart rate and 10, 20 and 30 Bpm above intrinsic heart rate (paced rhythm)
1225930|NCT00180323|E1|Reported Event|Group 1|
1225931|NCT00180271|B3|Baseline|Total|Total of all reporting groups
1225932|NCT00180271|B2|Baseline|Implantable Cardioverter Defibrillator Alone|Patients randomized to implantable cardioverter defibrillator (ICD) in addition to optimal pharmacologic therapy (as administered by the primary care physician). ICDs deliver shocks to terminate potentially lethal ventricular arrhythmias.
1225933|NCT00180271|B1|Baseline|Cardiac Resynchronization Therapy + Defibrillator|Patients randomized to cardiac resynchronization therapy with backup defibrillation (CRT-D) in addition to optimal pharmacologic therapy (as administered by the primary care physician). CRT-D devices both deliver shocks to terminate potentially lethal ventricular arrhythmias and pace both ventricles in patients with ventricular dyssynchrony.
1225934|NCT00180271|P2|Participant Flow|Implantable Cardioverter Defibrillator Alone|Patients randomized to implantable cardioverter defibrillator (ICD) in addition to optimal pharmacologic therapy (as administered by the primary care physician). ICDs deliver shocks to terminate potentially lethal ventricular arrhythmias.
1225935|NCT00180271|P1|Participant Flow|Cardiac Resynchronization Therapy + Defibrillator|Patients randomized to cardiac resynchronization therapy with backup defibrillation (CRT-D) in addition to optimal pharmacologic therapy (as administered by the primary care physician). CRT-D devices both deliver shocks to terminate potentially lethal ventricular arrhythmias and pace both ventricles in patients with ventricular dyssynchrony.
1225936|NCT00180271|O2|Outcome|Implantable Cardioverter Defibrillator Alone|Patients randomized to implantable cardioverter defibrillator (ICD) in addition to optimal pharmacologic therapy (as administered by the primary care physician). ICDs deliver shocks to terminate potentially lethal ventricular arrhythmias.
1226014|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
1225965|NCT00179660|E1|Reported Event|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
1225937|NCT00180271|O1|Outcome|Cardiac Resynchronization Therapy + Defibrillator|Patients randomized to cardiac resynchronization therapy with backup defibrillation (CRT-D) in addition to optimal pharmacologic therapy (as administered by the primary care physician). CRT-D devices both deliver shocks to terminate potentially lethal ventricular arrhythmias and pace both ventricles in patients with ventricular dyssynchrony.
1225938|NCT00180271|E2|Reported Event|Implantable Cardioverter Defibrillator Alone|Patients randomized to implantable cardioverter defibrillator (ICD) in addition to optimal pharmacologic therapy (as administered by the primary care physician). ICDs deliver shocks to terminate potentially lethal ventricular arrhythmias.
1225939|NCT00180271|E1|Reported Event|Cardiac Resynchronization Therapy + Defibrillator|Patients randomized to cardiac resynchronization therapy with backup defibrillation (CRT-D) in addition to optimal pharmacologic therapy (as administered by the primary care physician). CRT-D devices both deliver shocks to terminate potentially lethal ventricular arrhythmias and pace both ventricles in patients with ventricular dyssynchrony.
1225940|NCT00179959|B3|Baseline|Total|Total of all reporting groups
1225941|NCT00179959|B2|Baseline|Placebo|Intranasal petrolatum ointment treatment and plain water baths
1225942|NCT00179959|B1|Baseline|Treatment|Intranasal mupirocin ointment treatment and sodium hpochlorite (bleach baths)
1225943|NCT00179959|P2|Participant Flow|Placebo|Intranasal petrolatum ointment treatment and plain water baths
1225944|NCT00179959|P1|Participant Flow|Treatment|Intranasal mupirocin ointment treatment and sodium hpochlorite (bleach baths)
1225945|NCT00179959|O2|Outcome|Placebo|Intranasal petrolatum ointment treatment and plain water baths
1225946|NCT00179959|O1|Outcome|Treatment|Intranasal mupirocin ointment treatment and sodium hpochlorite (bleach baths)
1225947|NCT00179959|E2|Reported Event|Placebo|Intranasal petrolatum ointment treatment and plain water baths
1225948|NCT00179959|E1|Reported Event|Treatment|Intranasal mupirocin ointment treatment and sodium hpochlorite (bleach baths)
1225949|NCT00179673|B1|Baseline|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
1225950|NCT00179673|P1|Participant Flow|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
1225951|NCT00179673|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
1225952|NCT00179673|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
1225953|NCT00179673|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
1225954|NCT00179673|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
1225955|NCT00179673|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
1225956|NCT00179673|E1|Reported Event|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
1225957|NCT00179660|B1|Baseline|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
1225958|NCT00179660|P1|Participant Flow|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
1225959|NCT00179660|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
1225960|NCT00179660|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
1225961|NCT00179660|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
1225962|NCT00179660|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
1225963|NCT00179660|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
1225964|NCT00179660|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
1226015|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
1226016|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
1225966|NCT00179647|B1|Baseline|Lenalidomide|This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.
1225967|NCT00179647|P1|Participant Flow|Lenalidomide|This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.
1225968|NCT00179647|O1|Outcome|Lenalidomide|This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.
1225969|NCT00179647|E1|Reported Event|Lenalidomide|This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.
1225970|NCT00179621|B4|Baseline|Total|Total of all reporting groups
1225971|NCT00179621|B3|Baseline|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
1225972|NCT00179621|B2|Baseline|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
1225973|NCT00179621|B1|Baseline|Placebo|Placebo matching to active study arms.
1225974|NCT00179621|P4|Participant Flow|Placebo Crossover to 5 mg Open-label Period|Participants receiving placebo in the Double-Blind phase and Lenalidomide in the Open-Label phase.
1225975|NCT00179621|P3|Participant Flow|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
1225976|NCT00179621|P2|Participant Flow|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
1225977|NCT00179621|P1|Participant Flow|Placebo|Placebo matching to active study arms.
1225978|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
1225979|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
1225980|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
1225981|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
1225982|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
1225983|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
1225984|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
1225985|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
1225986|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
1225987|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
1225988|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
1225989|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
1225990|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
1225991|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
1225992|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
1225993|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
1225994|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
1225995|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
1225996|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
1225997|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
1225998|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
1225999|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
1226000|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
1226001|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
1226002|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
1226003|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
1226004|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
1226005|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
1226006|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
1226007|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
1226008|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
1226009|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
1226010|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
1226011|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
1226012|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
1226013|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
1226017|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
1226018|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
1226019|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
1226021|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
1226022|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
1226023|NCT00179621|E4|Reported Event|Placebo Crossover to 5 mg Open-label Period|Participants receiving placebo in the Double-Blind phase and Lenalidomide in the Open-Label phase.
1226024|NCT00179621|E3|Reported Event|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
1226025|NCT00179621|E2|Reported Event|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
1226026|NCT00179621|E1|Reported Event|Placebo|Placebo matching to active study arms.
1226027|NCT00179309|B3|Baseline|Total|Total of all reporting groups
1226028|NCT00179309|B2|Baseline|Arm II - Docetaxel Alone|"Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin (MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor(GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.~Docetaxel : given intravenous (IV)"
1226029|NCT00179309|B1|Baseline|Arm I - PANVAC + Docetaxel|"Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.~PANVAC-V : given subcutaneously~Sargramostim : given subcutaneously (NCI subjects only)~PANVAC-F : given subcutaneously~Docetaxel : given IV"
1226030|NCT00179309|P2|Participant Flow|Arm II - Docetaxel Alone|"Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin 1(MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.~Docetaxel : given intravenous (IV)"
1226031|NCT00179309|P1|Participant Flow|Arm I - PANVAC + Docetaxel|"Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.~PANVAC-V: given subcutaneously~Sargramostim : given subcutaneously (NCI subjects only)~PANVAC-F : given subcutaneously~Docetaxel : given IV"
1226032|NCT00179309|O2|Outcome|Arm II - Docetaxel Alone|"Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin (MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor(GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.~Docetaxel : given intravenous (IV)"
1226033|NCT00179309|O1|Outcome|Arm I - PANVAC + Docetaxel|"Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.~PANVAC-V : given subcutaneously~Sargramostim : given subcutaneously (NCI subjects only)~PANVAC-F : given subcutaneously~Docetaxel : given IV"
1226034|NCT00179309|O2|Outcome|Arm II - Docetaxel Alone|"Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin (MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor(GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.~Docetaxel : given intravenous (IV)"
1226035|NCT00179309|O1|Outcome|Arm I - PANVAC + Docetaxel|"Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.~PANVAC-V : given subcutaneously~Sargramostim : given subcutaneously (NCI subjects only)~PANVAC-F : given subcutaneously~Docetaxel : given IV"
1226061|NCT00178711|O1|Outcome|Hypothermia|"Induction and maintenance of moderate hypothermia to 33 degrees celsius achieved within 4 hours of injury and maintained for 48 hours.~Hypothermia: Induction of moderate hypothermia to 33 degrees celsius, within 4 hours from time of injury and maintained for 48 hours"
1226229|NCT00177970|O1|Outcome|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
1226062|NCT00178711|E4|Reported Event|Randomized to Normothermia Then Excluded|Maintenance of normothermia before trauma evaluation in ED and then excluded by second set of criteria
1226063|NCT00178711|E3|Reported Event|Randomized to Hypothermia and Then Excluded|Induction and maintenance of moderate hypothermia before trauma evaluation in ED and then excluded by second set of criteria
1226036|NCT00179309|E2|Reported Event|Arm II - Docetaxel Alone|"Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin (MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor(GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.~Docetaxel : given intravenous (IV)"
1226037|NCT00179309|E1|Reported Event|Arm I - PANVAC + Docetaxel|"Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.~PANVAC-V : given subcutaneously~Sargramostim : given subcutaneously (NCI subjects only)~PANVAC-F : given subcutaneously~Docetaxel : given IV"
1226038|NCT00178919|B3|Baseline|Total|Total of all reporting groups
1226039|NCT00178919|B2|Baseline|Hypertensives and Controls|To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system
1226040|NCT00178919|B1|Baseline|Autonomic Failure Patients|To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system.
1226041|NCT00178919|P2|Participant Flow|Hypertensives and Controls|The NO synthase inhibitor L-NMMA was infused intravenously at different doses (250, 500 mcg/kg/min) for 15 minutes each dose after acute transient pharmacological blockade of the autonomic nervous system with trimethaphan (4 mg/min) or with the autonomic nervous system intact.
1226042|NCT00178919|P1|Participant Flow|Autonomic Failure Patients|The NO synthase inhibitor L-NMMA was infused intravenously at different doses (125, 250 and 500 mcg/kg/min) until a systolic blood pressure of 150 mm Hg was reached.
1226043|NCT00178919|O2|Outcome|Hypertensives and Controls|To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system
1226044|NCT00178919|O1|Outcome|Autonomic Failure Patients|To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system.
1226045|NCT00178919|O2|Outcome|Hypertensives and Controls|To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system
1226046|NCT00178919|O1|Outcome|Autonomic Failure Patients|To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system.
1226047|NCT00178919|E2|Reported Event|Hypertensives and Controls|The NO synthase inhibitor L-NMMA was infused intravenously at different doses (250, 500 mcg/kg/min) for 15 minutes each dose after acute transient pharmacological blockade of the autonomic nervous system with trimethaphan (4 mg/min) or with the autonomic nervous system intact.
1226048|NCT00178919|E1|Reported Event|Autonomic Failure Patients|The NO synthase inhibitor L-NMMA was infused intravenously at different doses (125, 250 and 500 mcg/kg/min) until a systolic blood pressure of 150 mm Hg was reached.
1226049|NCT00178841|B1|Baseline|Single Arm Study|All enrolled patients received rosiglitazone in addition to oral bexarotene
1226050|NCT00178841|P1|Participant Flow|Rosiglitazone and Bexarotene|Patients maintained their dose of bexarotene during the study and added rosiglitazone. The initial dose of rosiglitazone was 4 mg once daily. If patients showed no response after 1 month and experienced no adverse effects, the dose was increased to a maximum of 8 mg once daily. Dose reductions of rosiglitazone or bexarotene were allowed during the study, but only if necessary to control AEs.
1226051|NCT00178841|O1|Outcome|Rosiglitazone and Bexarotene|Patients maintained their dose of bexarotene during the study and added rosiglitazone. The initial dose of rosiglitazone was 4 mg once daily. If patients showed no response after 1 month and experienced no adverse effects, the dose was increased to a maximum of 8 mg once daily. Dose reductions of rosiglitazone or bexarotene were allowed during the study, but only if necessary to control AEs.
1226052|NCT00178841|O1|Outcome|Rosiglitazone and Bexarotene|Patients maintained their dose of bexarotene during the study and added rosiglitazone. The initial dose of rosiglitazone was 4 mg once daily. If patients showed no response after 1 month and experienced no adverse effects, the dose was increased to a maximum of 8 mg once daily. Dose reductions of rosiglitazone or bexarotene were allowed during the study, but only if necessary to control AEs.
1226053|NCT00178841|O1|Outcome|Rosiglitazone and Bexarotene|All 4 enrolled patients received rosiglitazone in addition to oral bexarotene.
1226054|NCT00178841|E1|Reported Event|Rosiglitazone and Bexarotene|All enrolled patients received rosiglitazone in addition to oral bexarotene.
1226055|NCT00178711|B3|Baseline|Total|Total of all reporting groups
1226056|NCT00178711|B2|Baseline|Control|Treated at normothermia
1226057|NCT00178711|B1|Baseline|Hypothermia|"Induction and maintenance of moderate hypothermia to 33 degrees celsius achieved within 4 hours of injury and maintained for 48 hours.~Hypothermia: Induction of moderate hypothermia to 33 degrees celsius, within 4 hours from time of injury and maintained for 48 hours"
1226058|NCT00178711|P2|Participant Flow|Control|45 patients who had none of the second set of exclusion criteria and who has been randomized to normothermia served as the control group
1226059|NCT00178711|P1|Participant Flow|Hypothermia|"There were two sets of exclusion criteria-one in the field; the other after resuscitation in the ER. In the field, patients were excluded for suspected pregnancy, systolic blood pressure <110 mm Hg, diastolic blood pressure <60 mm Hg, sustained heart rate >120 beats per minute, or failure to be reached by study-affiliated personnel within 2.5 hours of injury.~Those that did not have any of the first set of exclusion criteria were further assessed for the presence of Glasgow Coma Scale 3-8 without life-threatening associated injuries. The second set of exclusion criteria were GCS 3 with nonreactive pupils, GCS 7-8 with normal brain CT scan, inability to obtain an accurate GCS, Abbreviated Injury Severity Score >4 for organs other than brain4, systolic blood pressure <110 mm Hg or diastolic blood pressure <60 mm Hg, persistent hypoxia, (oxygen saturation < 94%), or positive pregnancy test."
1226060|NCT00178711|O2|Outcome|Control|treated at normothermia
1226111|NCT00178477|E1|Reported Event|Group 1|MRI with Breath Hold
1226064|NCT00178711|E2|Reported Event|Randomized to Normothermia and Normothermia Maintained|Induction and maintenance of normothermia and not excluded by second set of exclusion criteria
1226065|NCT00178711|E1|Reported Event|Randomized to Hypothermia and Hypothermia Maintained|Induction and maintenance of moderate hypothermia and not excluded by second set of exclusion criteria
1226066|NCT00178685|B4|Baseline|Total|Total of all reporting groups
1226067|NCT00178685|B3|Baseline|Harm Reduction (HR)|The HR condition had the same features as EAS, but offered initiation of a first-line smoking cessation medication if unwilling to stop, but willing to reduce their cigarettes by half. Subjects were informed that there is no evidence to suggest that reducing cigarette use improves health, but that doing so might increase their confidence in stopping.
1226068|NCT00178685|B2|Baseline|Extended Autonomy Support (EAS|The EAS condition provided the same content as CC, but the intervention was extended: (1) from 6 to12 months; (2) to include 8 contacts (six in first 6 months and two in second 6-months); (3) by encouraging smokers to attend treatment, even if not ready to stop; and (4) by asking the smoker to bring an important other (non-health-care professional) to one 50-minute instructional session about how to support the smoker’s autonomy.
1226069|NCT00178685|B1|Baseline|Community Care|The CC condition was similar to the translated 6-month SDT and PHS Guideline-based intensive intervention validated in the previous trial and provided for the CC subjects who wanted to make a quit attempt. The clinical endpoint was to guide the subjects to be fully autonomous about stopping smoking, including not stopping if not willing to stop smoking. Once willing to stop, the Tobacco Dependence Counselor (TDC, 4 contacts) worked to provide problem solving and skills training as recommended in the PHS Guideline (Chapter 4) and the prescriber (2 visits) guided the subjects to be fully autonomous about use of effective medications. Those not wanting to stop within 30 days of the first appointment were asked to call back when ready.
1226070|NCT00178685|P3|Participant Flow|Harm Reduction (HR)|The HR condition had the same features as EAS, but offered initiation of a first-line smoking cessation medication if unwilling to stop, but willing to reduce their cigarettes by half. Subjects were informed that there is no evidence to suggest that reducing cigarette use improves health, but that doing so might increase their confidence in stopping.
1226071|NCT00178685|P2|Participant Flow|Extended Autonomy Support (EAS|The EAS condition provided the same content as CC, but the intervention was extended: (1) from 6 to12 months; (2) to include 8 contacts (six in first 6 months and two in second 6-months); (3) by encouraging smokers to attend treatment, even if not ready to stop; and (4) by asking the smoker to bring an important other (non-health-care professional) to one 50-minute instructional session about how to support the smoker’s autonomy.
1226072|NCT00178685|P1|Participant Flow|Community Care|The CC condition was similar to the translated 6-month SDT and PHS Guideline-based intensive intervention validated in the previous trial and provided for the CC subjects who wanted to make a quit attempt. The clinical endpoint was to guide the subjects to be fully autonomous about stopping smoking, including not stopping if not willing to stop smoking. Once willing to stop, the Tobacco Dependence Counselor (TDC, 4 contacts) worked to provide problem solving and skills training as recommended in the PHS Guideline (Chapter 4) and the prescriber (2 visits) guided the subjects to be fully autonomous about use of effective medications. Those not wanting to stop within 30 days of the first appointment were asked to call back when ready.
1226073|NCT00178685|O3|Outcome|Harm Reduction (HR)|The HR condition had the same features as EAS, but offered initiation of a first-line smoking cessation medication if unwilling to stop, but willing to reduce their cigarettes by half. Subjects were informed that there is no evidence to suggest that reducing cigarette use improves health, but that doing so might increase their confidence in stopping.
1226074|NCT00178685|O2|Outcome|Extended Autonomy Support (EAS|The EAS condition provided the same content as CC, but the intervention was extended: (1) from 6 to12 months; (2) to include 8 contacts (six in first 6 months and two in second 6-months); (3) by encouraging smokers to attend treatment, even if not ready to stop; and (4) by asking the smoker to bring an important other (non-health-care professional) to one 50-minute instructional session about how to support the smoker's autonomy.
1226075|NCT00178685|O1|Outcome|Community Care|The CC condition was similar to the translated 6-month SDT and PHS Guideline-based intensive intervention validated in the previous trial and provided for the CC subjects who wanted to make a quit attempt. The clinical endpoint was to guide the subjects to be fully autonomous about stopping smoking, including not stopping if not willing to stop smoking. Once willing to stop, the Tobacco Dependence Counselor (TDC, 4 contacts) worked to provide problem solving and skills training as recommended in the PHS Guideline (Chapter 4) and the prescriber (2 visits) guided the subjects to be fully autonomous about use of effective medications. Those not wanting to stop within 30 days of the first appointment were asked to call back when ready.
1226076|NCT00178685|O3|Outcome|Harm Reduction (HR)|The HR condition had the same features as EAS, but offered initiation of a first-line smoking cessation medication if unwilling to stop, but willing to reduce their cigarettes by half. Subjects were informed that there is no evidence to suggest that reducing cigarette use improves health, but that doing so might increase their confidence in stopping.
1226077|NCT00178685|O2|Outcome|Extended Autonomy Support (EAS|The EAS condition provided the same content as CC, but the intervention was extended: (1) from 6 to12 months; (2) to include 8 contacts (six in first 6 months and two in second 6-months); (3) by encouraging smokers to attend treatment, even if not ready to stop; and (4) by asking the smoker to bring an important other (non-health-care professional) to one 50-minute instructional session about how to support the smoker's autonomy.
1226078|NCT00178685|O1|Outcome|Community Care|The CC condition was similar to the translated 6-month SDT and PHS Guideline-based intensive intervention validated in the previous trial and provided for the CC subjects who wanted to make a quit attempt. The clinical endpoint was to guide the subjects to be fully autonomous about stopping smoking, including not stopping if not willing to stop smoking. Once willing to stop, the Tobacco Dependence Counselor (TDC, 4 contacts) worked to provide problem solving and skills training as recommended in the PHS Guideline (Chapter 4) and the prescriber (2 visits) guided the subjects to be fully autonomous about use of effective medications. Those not wanting to stop within 30 days of the first appointment were asked to call back when ready.
1226079|NCT00178685|E3|Reported Event|Harm Reduction (HR)|The HR condition had the same features as EAS, but offered initiation of a first-line smoking cessation medication if unwilling to stop, but willing to reduce their cigarettes by half. Subjects were informed that there is no evidence to suggest that reducing cigarette use improves health, but that doing so might increase their confidence in stopping.
1226080|NCT00178685|E2|Reported Event|Extended Autonomy Support (EAS|The EAS condition provided the same content as CC, but the intervention was extended: (1) from 6 to12 months; (2) to include 8 contacts (six in first 6 months and two in second 6-months); (3) by encouraging smokers to attend treatment, even if not ready to stop; and (4) by asking the smoker to bring an important other (non-health-care professional) to one 50-minute instructional session about how to support the smoker’s autonomy.
1226081|NCT00178685|E1|Reported Event|Community Care|The CC condition was similar to the translated 6-month SDT and PHS Guideline-based intensive intervention validated in the previous trial and provided for the CC subjects who wanted to make a quit attempt. The clinical endpoint was to guide the subjects to be fully autonomous about stopping smoking, including not stopping if not willing to stop smoking. Once willing to stop, the Tobacco Dependence Counselor (TDC, 4 contacts) worked to provide problem solving and skills training as recommended in the PHS Guideline (Chapter 4) and the prescriber (2 visits) guided the subjects to be fully autonomous about use of effective medications. Those not wanting to stop within 30 days of the first appointment were asked to call back when ready.
1226082|NCT00178633|B1|Baseline|Bariatric Surgery|Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
1226083|NCT00178633|P1|Participant Flow|Bariatric Surgery|
1226084|NCT00178633|O1|Outcome|Bariatric Surgery|Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
1226085|NCT00178633|O1|Outcome|Bariatric Surgery|Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
1226086|NCT00178633|O1|Outcome|Bariatric Surgery|Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
1226087|NCT00178633|O1|Outcome|Bariatric Surgery|Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
1226088|NCT00178633|E2|Reported Event|Bariatric Surgery, Follow up at 2 Years|Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
1226089|NCT00178633|E1|Reported Event|Bariatric Surgery, Follow up at 9 Months|Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
1226090|NCT00178503|B1|Baseline|MPH Trial|24 Participants with ASD-ADHD underwent 1 week of placebo, 1 week of Low dose, 1 week of Medium dose, and 1 week of High dose in the MPH treatment phase
1226091|NCT00178503|P1|Participant Flow|MPH Trial|24 participants with autism spectrum disorder and ADHD underwent a randomized, placebo-controlled, cross-over designed trial, which included: 1 week of placebo, 1 week of low dose methylphenidate, 1 week of medium dose methylphenidate, 1 week of high dose methylphenidate.
1226092|NCT00178503|O4|Outcome|MPH Trial: High Dose Week|Participants with ASD-ADHD underwent 1 week at a high dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
1226093|NCT00178503|O3|Outcome|MPH Trial: Med Dose Week|Participants with ASD-ADHD underwent 1 week at a medium dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
1226094|NCT00178503|O2|Outcome|MPH Trial: Low Dose Week|Participants with ASD-ADHD who will undergo 1 week at a low dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
1226095|NCT00178503|O1|Outcome|MPH Trial-Placebo Week|Participants with ASD-ADHD underwent 1 week of placebo in the MPH treatment phase
1226096|NCT00178503|O4|Outcome|MPH Trial: High Dose Week|Participants with ASD-ADHD underwent 1 week at a high dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
1226097|NCT00178503|O3|Outcome|MPH Trial: Med Dose Week|Participants with ASD-ADHD underwent 1 week at a medium dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
1226098|NCT00178503|O2|Outcome|MPH Trial: Low Dose Week|Participants with ASD-ADHD underwent 1 week at a low dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
1226099|NCT00178503|O1|Outcome|MPH Trial-Placebo Week|Participants with ASD-ADHD underwent 1 week of placebo in the MPH treatment phase
1226100|NCT00178503|O4|Outcome|MPH Trial: High Dose Week|All 24 participants with ASD-ADHD underwent 1 week at a high dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phasephase
1226101|NCT00178503|O3|Outcome|MPH Trial: Med Dose Week|All 24 participants with ASD-ADHD underwent 1 week at a medium dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
1226102|NCT00178503|O2|Outcome|MPH Trial: Low Dose Week|All 24 participants with ASD-ADHD underwent 1 week at a low dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
1226103|NCT00178503|O1|Outcome|MPH Trial-Placebo Week|All 24 participants with ASD-ADHD underwent 1 week of placebo in the MPH treatment phase
1226104|NCT00178503|E4|Reported Event|MPH Trial: High Dose|Participants with ASD-ADHD who will undergo 1 week at a high dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
1226105|NCT00178503|E3|Reported Event|MPH Trial: Med Dose|Participants with ASD-ADHD who will undergo 1 week at a medium dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
1226106|NCT00178503|E2|Reported Event|MPH Trial: Low Dose|Participants with ASD-ADHD who will undergo 1 week at a low dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
1226107|NCT00178503|E1|Reported Event|MPH Trial-Placebo|Participants with ASD-ADHD who will undergo 1 week of placebo in the MPH treatment phase
1226108|NCT00178477|B1|Baseline|Group 1|MRI with Breath Hold
1226109|NCT00178477|P1|Participant Flow|Breath Hold|MRI with Breath Hold
1226110|NCT00178477|O1|Outcome|Group 1|MRI with Breath Hold
1226112|NCT00178464|B1|Baseline|Aspirin|Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
1226231|NCT00177970|O1|Outcome|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
1226113|NCT00178464|P1|Participant Flow|Aspirin|Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
1226114|NCT00178464|O1|Outcome|Aspirin|Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
1226115|NCT00178464|O1|Outcome|Aspirin|Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
1226116|NCT00178464|E1|Reported Event|Aspirin|Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
1226117|NCT00177307|B1|Baseline|Oxaliplatin, Capecitabine, and Bevacizumab|"Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity~Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).~Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine"
1226118|NCT00177307|P1|Participant Flow|Oxaliplatin, Capecitabine, and Bevacizumab|"Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity~Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).~Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine"
1226119|NCT00177307|O1|Outcome|Oxaliplatin, Capecitabine, and Bevacizumab|"Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity~Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).~Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine"
1226120|NCT00177307|O1|Outcome|Oxaliplatin, Capecitabine, and Bevacizumab|"Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity~Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).~Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine"
1226121|NCT00177307|O1|Outcome|Oxaliplatin, Capecitabine, and Bevacizumab|"Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity~Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).~Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine"
1226122|NCT00177307|O1|Outcome|Oxaliplatin, Capecitabine, and Bevacizumab|"Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity~Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).~Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine"
1226123|NCT00177307|E1|Reported Event|Oxaliplatin, Capecitabine, and Bevacizumab|"Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity~Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).~Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine"
1226124|NCT00177294|B3|Baseline|Total|Total of all reporting groups
1226125|NCT00177294|B2|Baseline|Escitalopram Plus Depression Care Management (DCM)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management without interpersonal psychotherapy (IPT)
1226126|NCT00177294|B1|Baseline|Escitalopram Plus Interpersonal Psychotherapy (IPT)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT)
1226127|NCT00177294|P2|Participant Flow|Escitalopram Plus Depression Care Management (DCM)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management without interpersonal psychotherapy (IPT)
1226128|NCT00177294|P1|Participant Flow|Escitalopram Plus Interpersonal Psychotherapy (IPT)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT)
1226129|NCT00177294|O2|Outcome|Escitalopram Plus Depression Care Management (DCM)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management without interpersonal psychotherapy (IPT)
1226130|NCT00177294|O1|Outcome|Escitalopram Plus Interpersonal Psychotherapy (IPT)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT)
1226131|NCT00177294|E2|Reported Event|Escitalopram Plus Depression Care Management (DCM)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management without interpersonal psychotherapy (IPT)
1226132|NCT00177294|E1|Reported Event|Escitalopram Plus Interpersonal Psychotherapy (IPT)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT)
1226133|NCT00177255|B1|Baseline|Docetaxel + Capecitabine|"Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.~Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days. Cycle 2 will begin on day 22.~Docetaxel: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.~Cycle 2 will begin on day 22.~Capecitabine: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days.~Cycle 2 will begin on day 22."
1226134|NCT00177255|P1|Participant Flow|Docetaxel + Capecitabine|"Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.~Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days. Cycle 2 will begin on day 22.~Docetaxel: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.~Cycle 2 will begin on day 22.~Capecitabine: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days.~Cycle 2 will begin on day 22."
1226135|NCT00177255|O1|Outcome|Docetaxel + Capecitabine|"Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.~Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days. Cycle 2 will begin on day 22.~Docetaxel: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.~Cycle 2 will begin on day 22.~Capecitabine: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days.~Cycle 2 will begin on day 22."
1226136|NCT00177255|O1|Outcome|Docetaxel + Capecitabine|"Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.~Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days. Cycle 2 will begin on day 22.~Docetaxel: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.~Cycle 2 will begin on day 22.~Capecitabine: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days.~Cycle 2 will begin on day 22."
1226137|NCT00177255|E1|Reported Event|Docetaxel + Capecitabine|"Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.~Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days. Cycle 2 will begin on day 22.~Docetaxel: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.~Cycle 2 will begin on day 22.~Capecitabine: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days.~Cycle 2 will begin on day 22."
1226138|NCT00177216|B4|Baseline|Total|Total of all reporting groups
1226139|NCT00177216|B3|Baseline|Placebo Comparator: Placebo|A placebo capsule was given with instructions to take it every night by mouth, 30 minutes prior to bedtime.
1226140|NCT00177216|B2|Baseline|Experimental: Excitalopram|The antidepressant, escitalopram was initiated at 5 mg by mouth every night, 30 minutes prior to bedtime. If there were no side effects, the dose was increased every four days until the target dose of 20 mg (maximum dose) was reached by day 13. If significant side effects appeared, the highest tolerated dose was used.
1226226|NCT00177970|O2|Outcome|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
1226230|NCT00177970|O2|Outcome|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
1226232|NCT00177970|O2|Outcome|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
1226233|NCT00177970|O1|Outcome|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
1226141|NCT00177216|B1|Baseline|Experimental: Zolpidem|The benzodiazepine receptor agonist (BzRA), zolpidem was given in an initial dose of 5 mg by mouth every night, 30 minutes prior to bedtime. The dose was increased to a maximum of 10 mg after the first week if there was no improvement in overall symptoms (CGI score of 4 or >). The dose was decreased to 5 mg if side effects occurred.
1226142|NCT00177216|P3|Participant Flow|Placebo Comparator: Placebo|A placebo capsule was given with instructions to take it every night by mouth, 30 minutes prior to bedtime.
1226143|NCT00177216|P2|Participant Flow|Experimental: Excitalopram|The antidepressant, escitalopram was initiated at 5 mg by mouth every night, 30 minutes prior to bedtime. If there were no side effects, the dose was increased every four days until the target dose of 20 mg (maximum dose) was reached by day 13. If significant side effects appeared, the highest tolerated dose was used.
1226144|NCT00177216|P1|Participant Flow|Experimental: Zolpidem|The benzodiazepine receptor agonist (BzRA), zolpidem was given in an initial dose of 5 mg by mouth every night, 30 minutes prior to bedtime. The dose was increased to a maximum of 10 mg after the first week if there was no improvement in overall symptoms (CGI score of 4 or >). The dose was decreased to 5 mg if side effects occurred.
1226145|NCT00177216|O3|Outcome|Placebo|Participants receiving a placebo
1226146|NCT00177216|O2|Outcome|Escitalopram|Participants receiving an antidepressant, escitalopram
1226147|NCT00177216|O1|Outcome|Zolpidem|Participants receiving an benzodiazepine receptor agonist (BzRA), zolpidem
1226148|NCT00177216|O3|Outcome|Placebo Comparator: Placebo|A placebo capsule was given with instructions to take it every night by mouth, 30 minutes prior to bedtime.
1226149|NCT00177216|O2|Outcome|Experimental: Excitalopram|The antidepressant, escitalopram was initiated at 5 mg by mouth every night, 30 minutes prior to bedtime. If there were no side effects, the dose was increased every four days until the target dose of 20 mg (maximum dose) was reached by day 13. If significant side effects appeared, the highest tolerated dose was used.
1226150|NCT00177216|O1|Outcome|Experimental: Zolpidem|The benzodiazepine receptor agonist (BzRA), zolpidem was given in an initial dose of 5 mg by mouth every night, 30 minutes prior to bedtime. The dose was increased to a maximum of 10 mg after the first week if there was no improvement in overall symptoms (CGI score of 4 or >). The dose was decreased to 5 mg if side effects occurred.
1226151|NCT00177216|O3|Outcome|Placebo|Participants receiving a placebo
1226152|NCT00177216|O2|Outcome|Escitalpram|Participants receiving an antidepressant, escitalopram
1226153|NCT00177216|O1|Outcome|Zolpidem|Participants receiving an benzodiazepine receptor agonist (BzRA), zolpidem
1226154|NCT00177216|E3|Reported Event|Placebo|Participants receiving a placebo
1226155|NCT00177216|E2|Reported Event|Escitalopram|Participants receiving an antidepressant, escitalopram
1226156|NCT00177216|E1|Reported Event|Zolpidem|Participants receiving an benzodiazepine receptor agonist (BzRA), zolpidem
1226157|NCT00177164|B3|Baseline|Total|Total of all reporting groups
1226158|NCT00177164|B2|Baseline|Oral AAP|"Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole)~Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder"
1226159|NCT00177164|B1|Baseline|Risperidone LAI|"Oral Risperidone followed by Long acting Risperidone injections (Consta)~Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks"
1226160|NCT00177164|P2|Participant Flow|Oral AAP|"Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole)~Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder"
1226161|NCT00177164|P1|Participant Flow|Risperidone LAI|"Oral Risperidone followed by Long acting Risperidone injections (Consta)~Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks"
1226162|NCT00177164|O2|Outcome|Oral AAP|"Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole)~Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder"
1226163|NCT00177164|O1|Outcome|Risperidone LAI|"Oral Risperidone followed by Long acting Risperidone injections (Consta)~Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks"
1226164|NCT00177164|O2|Outcome|Oral AAP|"Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole)~Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder"
1226165|NCT00177164|O1|Outcome|Risperidone LAI|"Oral Risperidone followed by Long acting Risperidone injections (Consta)~Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks"
1226166|NCT00177164|O2|Outcome|Oral AAP|"Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole)~Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder"
1226167|NCT00177164|O1|Outcome|Risperidone LAI|"Oral Risperidone followed by Long acting Risperidone injections (Consta)~Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks"
1226168|NCT00177164|O2|Outcome|Oral AAP|"Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole)~Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder"
1226169|NCT00177164|O1|Outcome|Risperidone LAI|"Oral Risperidone followed by Long acting Risperidone injections (Consta)~Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks"
1226170|NCT00177164|E2|Reported Event|Oral AAP|
1226171|NCT00177164|E1|Reported Event|Risperidone LAI|
1226172|NCT00178256|B1|Baseline|Daily RT Plus Chemo on MWF|"Paclitaxel On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.~On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible~Radiation Therapy : Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible~Paclitaxel : On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am."
1234683|NCT00138671|O2|Outcome|Subcutaneous Insulin|
1226173|NCT00178256|P4|Participant Flow|Phase II Group (20mg/m2 Taxol)|"Once the MTD has been determined and confirmed with a total of six patients, up to 19 additional patients with measurable disease will be enrolled at that dose in order to obtain estimates of response rate and more information about toxicity Phase II enrollment will be in two stages. Initially 9 or 12 patients (depending on how many were tested at the MTD dose in the Phase I study) will be tested, for a total of 15 patients at the MTD. If fewer than 4 responses are observed, the study will end with 90% confidence that the true response rate is no greater than 40%, which is the minimum clinically interesting response rate.~If four or more responses are observed, additional patients will be enrolled to obtain 25 evaluable patients at the MTD. This will allow estimation of the true response rate and toxicity rates with standard errors of no more than 0.1."
1226174|NCT00178256|P3|Participant Flow|Third Dose Cohort (25mg/m2 Taxol) MWF and Daily RT|"A minimum of three patients will be assigned at each dose level.~If no DLTs are observed then the next three patients enrolled will receive a dose of 5 mg/m2 per dose more than the previous group.~If one or two instances of DLT are observed then an additional three patients will be tested at the same dose. If DLT is observed in at most two of six patients then dose escalation will continue in the next three patients enrolled.~Dose-limiting toxicity (DLT) is defined as grade 4 hematologic toxicity, or grade 3 and 4 non-hematologic toxicity excluding nausea and vomiting according to RTOG and Cooperative Group common toxicity criteria. The adverse event must be related to the treatment (paclitaxel or radiation) to be considered a DLT"
1226175|NCT00178256|P2|Participant Flow|Second Dose Cohort (20mg/m2 Taxol) MWF and Daily RT|"On Mondays, Wednesdays, and Fridays, paclitaxel infusion will given. On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given.~A minimum of three patients will be assigned at each dose level.~If no DLTs are observed then the next three patients enrolled will receive a dose of 5 mg/m2 per dose more than the previous group.~If one or two instances of DLT are observed then an additional three patients will be tested at the same dose. If DLT is observed in at most two of six patients then dose escalation will continue in the next three patients enrolled.~Dose-limiting toxicity (DLT) is defined as grade 4 hematologic toxicity, or grade 3 and 4 non-hematologic toxicity excluding nausea and vomiting according to RTOG and Cooperative Group common toxicity criteria. The adverse event must be related to the treatment (paclitaxel or radiation) to be considered a DLT"
1226176|NCT00178256|P1|Participant Flow|First Dose Cohort (15mg/m2 Taxol) MWF and Daily RT|"On Mondays, Wednesdays, and Fridays, paclitaxel infusion will given. On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given.~A minimum of three patients will be assigned at each dose level.~If no DLTs are observed then the next three patients enrolled will receive a dose of 5 mg/m2 per dose more than the previous group.~If one or two instances of DLT are observed then an additional three patients will be tested at the same dose. If DLT is observed in at most two of six patients then dose escalation will continue in the next three patients enrolled.~Dose-limiting toxicity (DLT) is defined as grade 4 hematologic toxicity, or grade 3 and 4 non-hematologic toxicity excluding nausea and vomiting according to RTOG and Cooperative Group common toxicity criteria. The adverse event must be related to the treatment (paclitaxel or radiation) to be considered a DLT"
1226177|NCT00178256|O1|Outcome|All Pts Enrolled Daily RT Plus Chemo on MWF|"Paclitaxel On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.~On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible~Radiation Therapy : Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible~Paclitaxel : On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am."
1226178|NCT00178256|O3|Outcome|3rd Dose Cohort --25mg/m2 Taxol Plus RT|"Paclitaxel: On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.~Radiation Therapy: Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible"
1226179|NCT00178256|O2|Outcome|2nd Dose cohort20 mg/m2 Taxol Plus Daily RT|"Paclitaxel: On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.~Radiation Therapy: Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible"
1226180|NCT00178256|O1|Outcome|1st Dose Cohort 15mg/m2 Taxol Plus RT|"15 mg/m2 Paclitaxel On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.~On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible~Paclitaxel: On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.~Radiation Therapy: Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible"
1226181|NCT00178256|E1|Reported Event|All Subjects Enrolled|
1226182|NCT00178191|B4|Baseline|Total|Total of all reporting groups
1226183|NCT00178191|B3|Baseline|Placebo|Placebo
1226184|NCT00178191|B2|Baseline|300 Units Botox|300 units Botulinum-A toxin
1226185|NCT00178191|B1|Baseline|200 Units Botox|200 units Botulinum-A toxin
1226186|NCT00178191|P3|Participant Flow|Placebo|Placebo
1226187|NCT00178191|P2|Participant Flow|300 Units Botox|300 units Botulinum-A toxin
1226188|NCT00178191|P1|Participant Flow|200 Units Botox|200 units Botulinum-A toxin
1226189|NCT00178191|O3|Outcome|Placebo|Placebo
1226190|NCT00178191|O2|Outcome|300 Units Botox|300 units Botulinum-A toxin
1226191|NCT00178191|O1|Outcome|200 Units Botox|200 units Botulinum-A toxin
1226192|NCT00178191|E3|Reported Event|Placebo|Placebo
1226193|NCT00178191|E2|Reported Event|300 Units Botox|300 units Botulinum-A toxin
1226194|NCT00178191|E1|Reported Event|200 Units Botox|200 units Botulinum-A toxin
1226195|NCT00178178|B5|Baseline|Total|Total of all reporting groups
1226196|NCT00178178|B4|Baseline|Placebo Comparator|"Receive liquid with no pain medication (placebo) through a catheter in one part of the operative knee via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
1226197|NCT00178178|B3|Baseline|Drug: Patellar Tendon Harvest Site and Intraarticular|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the Patellar Tendon Harvest Site and Intraarticular infusion via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
1226227|NCT00177970|O1|Outcome|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
1226228|NCT00177970|O2|Outcome|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
1226198|NCT00178178|B2|Baseline|Drug: Patellar Tendon Harvest Site Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the patellar tendon harvest site via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
1226199|NCT00178178|B1|Baseline|Drug: Intraarticularly Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) intraarticularly only via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
1226200|NCT00178178|P4|Participant Flow|Placebo|"Receive liquid with no pain medication (placebo) through a catheter in one part of the operative knee via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
1226201|NCT00178178|P3|Participant Flow|Patellar Tendon Harvest Site and Intraarticular|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the Patellar Tendon Harvest Site and Intraarticular infusion via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
1226202|NCT00178178|P2|Participant Flow|Patellar Tendon Harvest Site Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the patellar tendon harvest site via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
1226203|NCT00178178|P1|Participant Flow|Intraarticulary Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) intraarticularly only via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
1226204|NCT00178178|O4|Outcome|Placebo|"Receive liquid with no pain medication (placebo) through a catheter in one part of the operative knee via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
1226205|NCT00178178|O3|Outcome|Patellar Tendon Harvest Site and Intraarticular|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the Patellar Tendon Harvest Site and Intraarticular infusion via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
1226206|NCT00178178|O2|Outcome|Patellar Tendon Harvest Site Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the patellar tendon harvest site via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
1226207|NCT00178178|O1|Outcome|Intraarticulary Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) intraarticularly only via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
1226208|NCT00178178|E4|Reported Event|Placebo|"Receive liquid with no pain medication (placebo) through a catheter in one part of the operative knee via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
1226209|NCT00178178|E3|Reported Event|Patellar Tendon Harvest Site and Intraarticular|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the Patellar Tendon Harvest Site and Intraarticular infusion via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
1226210|NCT00178178|E2|Reported Event|Patellar Tendon Harvest Site Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the patellar tendon harvest site via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
1226211|NCT00178178|E1|Reported Event|Intraartciularly Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) intraarticularly only via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
1226212|NCT00178126|B3|Baseline|Total|Total of all reporting groups
1226213|NCT00178126|B2|Baseline|Skin Protection Cushion|"Receive seating assessment, wheelchair and cushion meeting CMS code for Skin Protection Wheelchair Cushion~Skin Protection Wheelchair Seat Cushion: Cushion receiving CMS code for Skin Protection Wheelchair Cushion"
1226214|NCT00178126|B1|Baseline|Segmented Foam Cushion|"Receive seating assessment, wheelchair and seat cushion representing the standard of care in nursing homes~Segmented Foam Wheelchair Seat Cushion: General use class wheelchair seat cushion"
1226215|NCT00178126|P2|Participant Flow|Skin Protection Cushion|"Receive seating assessment, wheelchair and cushion meeting CMS code for Skin Protection Wheelchair Cushion~Skin Protection Wheelchair Seat Cushion: Cushion receiving CMS code for Skin Protection Wheelchair Cushion"
1226216|NCT00178126|P1|Participant Flow|Segmented Foam Cushion|"Receive seating assessment, wheelchair and seat cushion representing the standard of care in nursing homes~Segmented Foam Wheelchair Seat Cushion: General use class wheelchair seat cushion"
1226217|NCT00178126|O2|Outcome|Skin Protection Cushion|"Receive seating assessment, wheelchair and cushion meeting CMS code for Skin Protection Wheelchair Cushion~Skin Protection Wheelchair Seat Cushion: Cushion receiving CMS code for Skin Protection Wheelchair Cushion"
1226218|NCT00178126|O1|Outcome|Segmented Foam Cushion|"Receive seating assessment, wheelchair and seat cushion representing the standard of care in nursing homes~Segmented Foam Wheelchair Seat Cushion: General use class wheelchair seat cushion"
1226219|NCT00178126|E2|Reported Event|Skin Protection Cushion|"Receive seating assessment, wheelchair and cushion meeting CMS code for Skin Protection Wheelchair Cushion~Skin Protection Wheelchair Seat Cushion: Cushion receiving CMS code for Skin Protection Wheelchair Cushion"
1226220|NCT00178126|E1|Reported Event|Segmented Foam Cushion|"Receive seating assessment, wheelchair and seat cushion representing the standard of care in nursing homes~Segmented Foam Wheelchair Seat Cushion: General use class wheelchair seat cushion"
1226221|NCT00177970|B3|Baseline|Total|Total of all reporting groups
1226222|NCT00177970|B2|Baseline|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
1226223|NCT00177970|B1|Baseline|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
1226224|NCT00177970|P2|Participant Flow|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
1226225|NCT00177970|P1|Participant Flow|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
1226234|NCT00177970|O2|Outcome|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
1226235|NCT00177970|O1|Outcome|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
1226236|NCT00177970|O2|Outcome|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
1226237|NCT00177970|O1|Outcome|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
1226238|NCT00177970|O2|Outcome|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
1226239|NCT00177970|O1|Outcome|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
1226240|NCT00177970|O2|Outcome|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
1226241|NCT00177970|O1|Outcome|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
1226242|NCT00177970|E2|Reported Event|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
1226243|NCT00177970|E1|Reported Event|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
1226244|NCT00177866|B3|Baseline|Total|Total of all reporting groups
1226245|NCT00177866|B2|Baseline|Placebo Followed by Celebrex|"Placebo PO BID for the first 8 weeks, followed by a 1 week washout period then Celebrex 200 mg PO BID for the remaining 8 weeks."
1226246|NCT00177866|B1|Baseline|Celebrex Followed by Placebo|"either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks~Celebrex: Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week washout period then placebo PO BID for the remaining 8 weeks -"
1226247|NCT00177866|P2|Participant Flow|Placebo Followed by Celebrex|"Placebo PO BID for the first 8 weeks, followed by a 1 week washout period then Celebrex 200 mg PO BID for the remaining 8 weeks."
1226248|NCT00177866|P1|Participant Flow|Celebrex Followed by Placebo|"either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks~Celebrex: Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week washout period then placebo PO BID for the remaining 8 weeks -"
1226249|NCT00177866|O2|Outcome|Placebo Followed by Celebrex|"Placebo PO BID for the first 8 weeks, followed by a 1 week washout period then Celebrex 200 mg PO BID for the remaining 8 weeks."
1226250|NCT00177866|O1|Outcome|Celebrex Followed by Placebo|"either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks~Celebrex: Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week washout period then placebo PO BID for the remaining 8 weeks -"
1226251|NCT00177866|O2|Outcome|Placebo Followed by Celebrex|"Placebo PO BID for the first 8 weeks, followed by a 1 week washout period then Celebrex 200 mg PO BID for the remaining 8 weeks."
1226252|NCT00177866|O1|Outcome|Celebrex Followed by Placebo|"either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks~Celebrex: Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week washout period then placebo PO BID for the remaining 8 weeks -"
1226253|NCT00177866|E2|Reported Event|Placebo Followed by Celebrex|"Placebo PO BID for the first 8 weeks, followed by a 1 week washout period then Celebrex 200 mg PO BID for the remaining 8 weeks."
1226254|NCT00177866|E1|Reported Event|Celebrex Followed by Placebo|"either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks~Celebrex: Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week washout period then placebo PO BID for the remaining 8 weeks -"
1226255|NCT00177671|B3|Baseline|Total|Total of all reporting groups
1226256|NCT00177671|B2|Baseline|Placebo|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo
1226257|NCT00177671|B1|Baseline|Donepezil|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
1226258|NCT00177671|P2|Participant Flow|Placebo|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo
1226259|NCT00177671|P1|Participant Flow|Donepezil|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
1226260|NCT00177671|O2|Outcome|Placebo|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo
1226261|NCT00177671|O1|Outcome|Donepezil|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
1226262|NCT00177671|O2|Outcome|Placebo|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo
1226263|NCT00177671|O1|Outcome|Donepezil|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
1226264|NCT00177671|O2|Outcome|Placebo|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo
1226265|NCT00177671|O1|Outcome|Donepezil|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
1226266|NCT00177671|O2|Outcome|Placebo|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo
1226267|NCT00177671|O1|Outcome|Donepezil|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
1226268|NCT00177671|E2|Reported Event|Placebo|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo
1226269|NCT00177671|E1|Reported Event|Donepezil|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
1226270|NCT00176917|B1|Baseline|Transplant Patients|Patients that received hematopoietic stem cell transplant.
1226271|NCT00176917|P1|Participant Flow|Transplant Patients|Patients that received hematopoietic stem cell transplant.
1226272|NCT00176917|O1|Outcome|Transplant Patients|Patients that received hematopoietic stem cell transplant.
1226273|NCT00176917|O1|Outcome|Transplant Patients|Patients that received hematopoietic stem cell transplant.
1226274|NCT00176917|O1|Outcome|Transplant Patients|Patients that received hematopoietic stem cell transplant.
1226275|NCT00176917|O1|Outcome|Transplant Patients|Patients that received hematopoietic stem cell transplant.
1226276|NCT00176917|E1|Reported Event|Transplant Patients|Patients that received hematopoietic stem cell transplant.
1226277|NCT00176904|B1|Baseline|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
1226278|NCT00176904|P1|Participant Flow|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
1226279|NCT00176904|O1|Outcome|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
1226280|NCT00176904|O1|Outcome|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
1226281|NCT00176904|O1|Outcome|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
1226282|NCT00176904|O1|Outcome|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
1226283|NCT00176904|O1|Outcome|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
1226284|NCT00176904|E1|Reported Event|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
1226285|NCT00176878|B1|Baseline|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
1226286|NCT00176878|P1|Participant Flow|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
1226287|NCT00176878|O1|Outcome|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
1226288|NCT00176878|O1|Outcome|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
1226289|NCT00176878|O1|Outcome|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
1226290|NCT00176878|O1|Outcome|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
1226291|NCT00176878|O1|Outcome|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
1226292|NCT00176878|O1|Outcome|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
1226293|NCT00176878|E1|Reported Event|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
1226294|NCT00176865|B4|Baseline|Total|Total of all reporting groups
1226295|NCT00176865|B3|Baseline|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226296|NCT00176865|B2|Baseline|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226297|NCT00176865|B1|Baseline|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226298|NCT00176865|P3|Participant Flow|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226299|NCT00176865|P2|Participant Flow|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226300|NCT00176865|P1|Participant Flow|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226301|NCT00176865|O3|Outcome|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226302|NCT00176865|O2|Outcome|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226303|NCT00176865|O1|Outcome|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226304|NCT00176865|O3|Outcome|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226305|NCT00176865|O2|Outcome|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226306|NCT00176865|O1|Outcome|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226307|NCT00176865|O3|Outcome|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226308|NCT00176865|O2|Outcome|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226309|NCT00176865|O1|Outcome|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226310|NCT00176865|O3|Outcome|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226311|NCT00176865|O2|Outcome|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226312|NCT00176865|O1|Outcome|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226313|NCT00176865|O3|Outcome|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226314|NCT00176865|O2|Outcome|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226315|NCT00176865|O1|Outcome|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226316|NCT00176865|O3|Outcome|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226317|NCT00176865|O2|Outcome|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226318|NCT00176865|O1|Outcome|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226319|NCT00176865|O3|Outcome|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226320|NCT00176865|O2|Outcome|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226321|NCT00176865|O1|Outcome|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226322|NCT00176865|O3|Outcome|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226404|NCT00176839|O1|Outcome|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
1226323|NCT00176865|O2|Outcome|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226324|NCT00176865|O1|Outcome|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226325|NCT00176865|O3|Outcome|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226326|NCT00176865|O2|Outcome|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226327|NCT00176865|O1|Outcome|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226328|NCT00176865|O3|Outcome|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226329|NCT00176865|O2|Outcome|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226330|NCT00176865|O1|Outcome|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226331|NCT00176865|E3|Reported Event|Arm 3 - Mismatched Double Cord Donors|"two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226332|NCT00176865|E2|Reported Event|Arm 2 - Matched Unrelated Donor|"HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor,~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226333|NCT00176865|E1|Reported Event|Arm 1 - Matched Sibling Donor|"human leukocyte antigen (HLA) genotypic matched sibling donor~Stem Cell Transplant: Reduced intensity chemotherapy followed by infusion of hematopoietic stem cells~Fludarabine, melphalan, ATG or Campath: all drugs are given intravenously (IV). Fludarabine x 5 days and melphalan x 1 day"
1226334|NCT00176852|B4|Baseline|Total|Total of all reporting groups
1226335|NCT00176852|B3|Baseline|Campath and TBI Conditioning (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226336|NCT00176852|B2|Baseline|Busulfan Conditioning (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226337|NCT00176852|B1|Baseline|Full Conditioning (Discontinued / A)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
1226338|NCT00176852|P3|Participant Flow|Campath and TBI Conditioning (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226339|NCT00176852|P2|Participant Flow|Busulfan Conditioning (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226405|NCT00176839|O1|Outcome|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
1234684|NCT00138671|O1|Outcome|Inhaled Insulin|
1226410|NCT00176826|O1|Outcome|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
1226340|NCT00176852|P1|Participant Flow|Full Conditioning (Discontinued / A)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
1226341|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226342|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226343|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
1226344|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226345|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226346|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
1226347|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226348|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226349|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
1226350|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226351|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226406|NCT00176839|E1|Reported Event|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
1226555|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
1226352|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
1226353|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226354|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226355|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
1226356|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226357|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226358|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
1226359|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226360|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226361|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
1226362|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226363|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226407|NCT00176826|B1|Baseline|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
1226556|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
1226364|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
1226365|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226366|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226367|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
1226368|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226369|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226370|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
1226371|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226372|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226373|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
1226374|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226375|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226408|NCT00176826|P1|Participant Flow|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
1234685|NCT00138671|O2|Outcome|Subcutaneous Insulin|
1226376|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
1226377|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226378|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226379|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
1226380|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226381|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226382|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
1226383|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226384|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226385|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
1226386|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226387|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226409|NCT00176826|O1|Outcome|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
1226557|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
1226388|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
1226389|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226390|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226391|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
1226392|NCT00176852|O3|Outcome|RIC Cy/Flu/TBI (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226393|NCT00176852|O2|Outcome|MA Bu/Cy (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226394|NCT00176852|O1|Outcome|RIC Bu/Flu (A) (Discontinued)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
1226395|NCT00176852|E3|Reported Event|Campath and TBI Conditioning (A2)|"Patients with sickle cell disease or thalassemia who do not have an HLA-identical sibling donor or who has pre-existing organ dysfunction making myeloablative condition ineligible will receive Campath on day -10 through -6, Cyclophosphamide on day -7, Fludarabine on day -6 through -2, total body irradiation (TBI) on day -1, stem cell infusion on Day 0.~Campath, Fludarabine, Cyclophosphamide: Receives Campath-1H 0.2 mg/kg Days -10 through -6, Fludarabine 35 mg/m2 intravenous (IV) Days -6 through -2, total body irradiation (TBI) 300 cGy Day -1.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226396|NCT00176852|E2|Reported Event|Busulfan Conditioning (B)|"Myeloablative Preparative Regimen for subjects with HLA identical sibling donors consists of Busulfan on day -9 through -6, Cyclophosphamide on day -5 through -2, ATG on day -3 through -1, stem cell infusion on Day 0 and Granulocyte Colony Stimulating Factor on day -3 until ANC >2500 x 2 days.~Busulfan, Cyclophosphamide, ATG, GCSF: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -9 through -6 Cyclophosphamide 50 mg/kg IV Days -5 through -2 ATG 30 mg/kg IV Day -1 GCSF 5 mcg/kg/day IV until ANC >2500 x 2 days.~Total Body Irradiation: 300 cGY Day -1~Stem cell infusion: Given Day 0"
1226397|NCT00176852|E1|Reported Event|Full Conditioning (Discontinued / A)|"Full Preparative Regimen for subjects with matched donors using Busulfan on Day -8 and -7, Fludarabine on Day -6 through -2, antithymocyte globulin (ATG) on Day -2 through -1, total lymphoid radiation (TLI) on Day -1, stem cell infusion on Day 0.~Busulfan, Fludarabine, ATG, TLI: Busulfan 0.8 mg/kg/dose intravenous (IV) Days -8 and -7 Fludarabine 35 mg/m2 IV Days -6 through -2 Antithymocyte globulin (ATG) 30 mg/kg IV Days -2 and -1 Total lymphoid radiation 300 cGy"
1226398|NCT00176839|B1|Baseline|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
1226399|NCT00176839|P1|Participant Flow|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
1226400|NCT00176839|O1|Outcome|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
1226401|NCT00176839|O1|Outcome|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
1226402|NCT00176839|O1|Outcome|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
1226403|NCT00176839|O1|Outcome|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
1226547|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
1226411|NCT00176826|O1|Outcome|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
1226412|NCT00176826|O1|Outcome|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
1226413|NCT00176826|O1|Outcome|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
1226414|NCT00176826|O1|Outcome|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
1226415|NCT00176826|O1|Outcome|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
1226416|NCT00176826|E1|Reported Event|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
1226417|NCT00176800|B1|Baseline|Chemoradiation and Tetrathiomolybdate (TM)|"Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.~Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.~Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50."
1226418|NCT00176800|P1|Participant Flow|Chemoradiation and Tetrathiomolybdate (TM)|"Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.~Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.~Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50."
1226419|NCT00176800|O1|Outcome|Chemoradiation and Tetrathiomolybdate (TM)|"Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.~Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.~Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50."
1226420|NCT00176800|O1|Outcome|Chemoradiation and Tetrathiomolybdate (TM)|"Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.~Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.~Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50."
1226421|NCT00176800|O1|Outcome|Chemoradiation and Tetrathiomolybdate (TM)|"Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.~Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.~Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50."
1226422|NCT00176800|E1|Reported Event|Chemoradiation and Tetrathiomolybdate (TM)|"Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.~Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.~Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50."
1226423|NCT00176644|B1|Baseline|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.~The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
1226424|NCT00176644|P1|Participant Flow|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.~The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
1226548|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
1226491|NCT00176202|B1|Baseline|Risperidone|"Risperidone is an antipsychotic medication and is used to treat mania. Its trade name is Risperdal.~Aim of the study is to cross compare the relative efficacy and safety of risperidone and divalproex sodium in treating/stabilizing mania in pediatric bipolar disorder."
1226425|NCT00176644|O1|Outcome|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.~The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
1226426|NCT00176644|O1|Outcome|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.~The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
1226427|NCT00176644|O1|Outcome|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.~The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
1226428|NCT00176644|O1|Outcome|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.~The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
1226429|NCT00176644|O1|Outcome|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.~The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
1226430|NCT00176644|E1|Reported Event|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.~The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
1226431|NCT00176631|B1|Baseline|Licorice Root Extract and Docetaxel|"licorice root extract : Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle.~docetaxel : All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle."
1226432|NCT00176631|P1|Participant Flow|Licorice Root Extract and Docetaxel|"licorice root extract : Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle.~docetaxel : All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle."
1226433|NCT00176631|O1|Outcome|Licorice Root Extract and Docetaxel|"licorice root extract : Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle.~docetaxel : All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle."
1226434|NCT00176631|O1|Outcome|Licorice Root Extract and Docetaxel|"licorice root extract : Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle.~docetaxel : All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle."
1226435|NCT00176631|E1|Reported Event|Licorice Root Extract and Docetaxel|"licorice root extract : Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle.~docetaxel : All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle."
1226436|NCT00176605|B1|Baseline|Arm 1 (Etoposide + Cyclophosphamide)|"Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.~Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration"
1226437|NCT00176605|P1|Participant Flow|Arm 1 (Etoposide + Cyclophosphamide)|"Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.~Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration"
1226438|NCT00176605|O1|Outcome|Arm 1 (Etoposide + Cyclophosphamide)|"Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.~Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration"
1226439|NCT00176605|O1|Outcome|Arm 1 (Etoposide + Cyclophosphamide)|"Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.~Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration"
1226440|NCT00176605|E1|Reported Event|Arm 1 (Etoposide + Cyclophosphamide)|"Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.~Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration"
1226441|NCT00176501|B1|Baseline|Irradiated Allogeneic Lymphocytes|therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
1226442|NCT00176501|P1|Participant Flow|Irradiated Allogeneic Lymphocytes|therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
1226443|NCT00176501|O1|Outcome|Irradiated Allogeneic Lymphocytes|therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
1226444|NCT00176501|O1|Outcome|Irradiated Allogeneic Lymphocytes|therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
1226445|NCT00176501|O1|Outcome|Irradiated Allogeneic Lymphocytes|therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
1226446|NCT00176501|E1|Reported Event|Irradiated Allogeneic Lymphocytes|therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
1226447|NCT00176488|B1|Baseline|Sequential Epirubicin/Vinorelbine|"For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.~epirubicin : Epirubicin (100 mg/m2) will be given on Day 1~vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17."
1226448|NCT00176488|P1|Participant Flow|Sequential Epirubicin/Vinorelbine|"For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.~epirubicin : Epirubicin (100 mg/m2) will be given on Day 1~vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17.~Beginning on cycle 1, patients will receive G-CSF (Neupogen) at a dose of 5 mcg/kg on Day 4 of treatment for 10 days OR pegfilgrastim (Neulasta) 6 mg on Day 4 of treatment."
1226449|NCT00176488|O1|Outcome|Sequential Epirubicin/Vinorelbine|"For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.~epirubicin : Epirubicin (100 mg/m2) will be given on Day 1~vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17."
1226450|NCT00176488|O1|Outcome|Sequential Epirubicin/Vinorelbine|"For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.~epirubicin : Epirubicin (100 mg/m2) will be given on Day 1~vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17."
1226451|NCT00176488|O1|Outcome|Sequential Epirubicin/Vinorelbine|"For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.~epirubicin : Epirubicin (100 mg/m2) will be given on Day 1~vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17."
1226549|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
1226550|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
1226452|NCT00176488|E1|Reported Event|Sequential Epirubicin/Vinorelbine|"For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.~epirubicin : Epirubicin (100 mg/m2) will be given on Day 1~vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17."
1226453|NCT00176462|B3|Baseline|Total|Total of all reporting groups
1226454|NCT00176462|B2|Baseline|Arm 2 High Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
1226455|NCT00176462|B1|Baseline|Arm 1 Standard Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin
1226456|NCT00176462|P2|Participant Flow|Arm 2 High Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
1226457|NCT00176462|P1|Participant Flow|Arm 1 Standard Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin
1226458|NCT00176462|O2|Outcome|Arm 2 High Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
1226459|NCT00176462|O1|Outcome|Arm 1 Standard Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin
1226460|NCT00176462|O1|Outcome|Arm 2 High Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
1226461|NCT00176462|E2|Reported Event|Arm 2 High Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
1226462|NCT00176462|E1|Reported Event|Arm 1 Standard Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin
1226463|NCT00176436|B3|Baseline|Total|Total of all reporting groups
1226464|NCT00176436|B2|Baseline|Placebo|Placebo medication, diet support group weekly and exercise sessions 3 times/week
1226465|NCT00176436|B1|Baseline|Active|Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24.
1226466|NCT00176436|P2|Participant Flow|Placebo|Placebo medication, diet support group weekly and exercise sessions 3 times/week
1226467|NCT00176436|P1|Participant Flow|Active|Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24.
1226468|NCT00176436|O2|Outcome|Placebo|Placebo medication, diet support group weekly and exercise sessions 3 times/week
1226469|NCT00176436|O1|Outcome|Active|Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24.
1226470|NCT00176436|E2|Reported Event|Placebo|Placebo medication, diet support group weekly and exercise sessions 3 times/week
1226471|NCT00176436|E1|Reported Event|Active|Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24.
1226472|NCT00176306|B1|Baseline|Levofloxacin Arm|patients receiving levofloxacin
1226473|NCT00176306|P1|Participant Flow|Levofloxacin Arm|Patients receive commercially available levofloxacin 750mg solution for intravnous use
1226474|NCT00176306|O1|Outcome|Levofloxacin Arm|Subjects receiving levofloxacin
1226475|NCT00176306|E1|Reported Event|Levofloxacin Arm|patients receiving levofloxacin
1226476|NCT00176254|B1|Baseline|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22~Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22~Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
1226477|NCT00176254|P1|Participant Flow|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22~Paclitaxel : 225 mg/m^2 intravenously over three hours on Days 1 and 22~Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
1226478|NCT00176254|O1|Outcome|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22~Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22~Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
1226479|NCT00176254|O1|Outcome|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22~Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22~Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
1226480|NCT00176254|O1|Outcome|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22~Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22~Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
1226481|NCT00176254|O1|Outcome|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22~Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22~Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
1226482|NCT00176254|O1|Outcome|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22~Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22~Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
1226483|NCT00176254|E1|Reported Event|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22~Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22~Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
1226484|NCT00176228|B1|Baseline|Lamotrigine|upto 200 mg
1226485|NCT00176228|P1|Participant Flow|Lamotrigine|upto 200 mg
1226486|NCT00176228|O1|Outcome|Lamotrigine|Lamotrigine: Response on CDRS-R
1226487|NCT00176228|O1|Outcome|Lamotrigine Effectiveness on YMRS (Mania Measure)|
1226488|NCT00176228|E1|Reported Event|Lamotrigine|upto 200 mg
1226489|NCT00176202|B3|Baseline|Total|Total of all reporting groups
1226490|NCT00176202|B2|Baseline|Divalproex|Divalproex sodium, also referred to as divalproex is an antiepileptic medication used for mania and is referred to as mood stabilizer. Its trade name is Depakote.
1226492|NCT00176202|P2|Participant Flow|Divalproex Sodium|This is antiepileptic medication and is a comparator drug to see if it is as efficacious as risperidone assumption is both have equal efficacy with no difference between the two.
1226493|NCT00176202|P1|Participant Flow|Risperidone|The study aimed to compare the antipsychotic medication i.e., risperidone's efficacy with that of divalproex sodium (which is an antiepileptic medication) in treating/stabilizing pediatric bipolar disorder.
1226494|NCT00176202|O2|Outcome|Divalproex Sodium|Antiepileptic medication used as mood stabilizer/antimanic agent
1226495|NCT00176202|O1|Outcome|Risperidone|Antipsychotic medication used as a anti manic agent
1226496|NCT00176202|O2|Outcome|Divalproex Sodium|Antiepileptic medication used as mood stabilizer/antimanic agent
1226497|NCT00176202|O1|Outcome|Risperidone|Antipsychotic medication used as a anti manic agent
1226498|NCT00176202|O2|Outcome|Risperidone|Risperidone was initiated at 0.25 mg to 0.50 mg per day. The dose was titrated to a maximum of 2 mg per day by increments of 0.25–0.5 mg every 2 days to achieve a maximum tolerable level by day 7.
1226499|NCT00176202|O1|Outcome|Divalproex|Divalproex was titrated up to 15 mg/kg/day over 3 days and serum level was measured at the end of 5 days. Divalproex dose was immediately adjusted on obtaining the serum level to aim for 80–120 μg/ml- trough, while ensuring that the dose was tolerated when increased. Serum valproate level was repeated at the end of the study.
1226500|NCT00176202|O2|Outcome|Risperidone|Risperidone was initiated at 0.25 mg to 0.50 mg per day. The dose was titrated to a maximum of 2 mg per day by increments of 0.25–0.5 mg every 2 days to achieve a maximum tolerable level by day 7.
1226501|NCT00176202|O1|Outcome|Divalproex|Divalproex was titrated up to 15 mg/kg/day over 3 days and serum level was measured at the end of 5 days. Divalproex dose was immediately adjusted on obtaining the serum level to aim for 80–120 μg/ml- trough, while ensuring that the dose was tolerated when increased. Serum valproate level was repeated at the end of the study.
1226502|NCT00176202|E2|Reported Event|Depakote or Divalproex Sodium|"Likely side effects include gastrointestinal side effects such as stomach discomfort, weight gain, agitation and sedation, fatigue or tiredness.~Clarification: We did not note any serious side effects with either drug. We reported any adverse event that is found in greater than 5% of the participants in each group. Frequency of adverse events do not equal the fact that they are serious adverse events at any individual level."
1226503|NCT00176202|E1|Reported Event|Risperidone|"Likely side effects include weight gain, muscle stiffness, sedation and tiredness.~Clarification: We did not note any serious side effects with either drug. We reported any adverse event that is found in greater than 5% of the participants in each group. Frequency of adverse events do not equal the fact that they are serious adverse events at any individual level."
1226504|NCT00175877|B1|Baseline|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1226505|NCT00175877|P1|Participant Flow|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1226506|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1226507|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1226508|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1226509|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1226510|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1226551|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
1226558|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
1226559|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
1226560|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
1226511|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1226512|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1226513|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1226514|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1226515|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1226516|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1226517|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1226518|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1226519|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1226520|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1226521|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1226522|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1226523|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1226552|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
1226553|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
1226554|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
1226524|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1226525|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1226526|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1226527|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1226528|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1226529|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1226530|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1226531|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1226532|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1226533|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1226534|NCT00175877|E1|Reported Event|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1226535|NCT00175019|B4|Baseline|Total|Total of all reporting groups
1226536|NCT00175019|B3|Baseline|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
1226537|NCT00175019|B2|Baseline|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
1226538|NCT00175019|B1|Baseline|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
1226539|NCT00175019|P3|Participant Flow|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
1226540|NCT00175019|P2|Participant Flow|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
1226541|NCT00175019|P1|Participant Flow|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
1226542|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
1226543|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
1226544|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
1226545|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
1226546|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
1226561|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
1226562|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
1226563|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
1226564|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
1226565|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
1226566|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
1226567|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
1226568|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
1226569|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
1226570|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
1226571|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
1226572|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
1226573|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
1226574|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
1226575|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
1226576|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
1226577|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
1226578|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
1226579|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
1226580|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
1226581|NCT00175019|E3|Reported Event|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
1226582|NCT00175019|E2|Reported Event|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
1226583|NCT00175019|E1|Reported Event|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
1226584|NCT00175006|B1|Baseline|Tophi Participants|Participants with palpable tophi >10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters.
1226585|NCT00175006|P1|Participant Flow|Tophi Participants|Participants with palpable tophi >10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters.
1226586|NCT00175006|O1|Outcome|Tophi Participants|Participants with palpable tophi >10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters.
1226587|NCT00175006|O1|Outcome|Tophi Participants|Participants with palpable tophi >10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters.
1226588|NCT00175006|E1|Reported Event|Tophi Participants|Participants with palpable tophi >10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters.
1226589|NCT00174967|B5|Baseline|Total|Total of all reporting groups
1226590|NCT00174967|B4|Baseline|Placebo QD|Placebo, orally, once daily
1226591|NCT00174967|B3|Baseline|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
1226592|NCT00174967|B2|Baseline|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
1226593|NCT00174967|B1|Baseline|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
1226594|NCT00174967|P4|Participant Flow|Placebo QD|Placebo, orally, once daily
1226595|NCT00174967|P3|Participant Flow|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
1226596|NCT00174967|P2|Participant Flow|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
1226597|NCT00174967|P1|Participant Flow|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
1226598|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
1226599|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
1226600|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
1226601|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
1226602|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
1226603|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
1226604|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
1226605|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
1226606|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
1226607|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
1226608|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
1226609|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
1226610|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
1226611|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
1226612|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
1226613|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
1226614|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
1226615|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
1226616|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
1226617|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
1226618|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
1226619|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
1226620|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
1226621|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
1226622|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
1226623|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
1226624|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
1226625|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
1226626|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
1226627|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
1226628|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
1226629|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
1226630|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
1226631|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
1226632|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
1226633|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
1226634|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
1226635|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
1226636|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
1226637|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
1226638|NCT00174967|E4|Reported Event|Placebo QD|Placebo, orally, once daily
1226639|NCT00174967|E3|Reported Event|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
1226640|NCT00174967|E2|Reported Event|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
1226641|NCT00174967|E1|Reported Event|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
1226642|NCT00174954|B1|Baseline|Palpable Gouty Tophi Subjects|Volumes/measurements of tophi determined by serial MRI
1226643|NCT00174954|P1|Participant Flow|Palpable Gouty Tophi Subjects|Volumes/measurements of tophi determined by serial MRI
1226644|NCT00174954|O1|Outcome|Palpable Gouty Tophi Subjects|Volumes/measurements of tophi determined by serial MRI
1226645|NCT00174954|O1|Outcome|Palpable Gouty Tophi Subjects|Volumes/measurements of tophi determined by serial MRI
1226646|NCT00174954|E1|Reported Event|Palpable Gouty Tophi Subjects|Volumes/measurements of tophi determined by serial MRI
1226647|NCT00174941|B4|Baseline|Total|Total of all reporting groups
1226648|NCT00174941|B3|Baseline|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level
1226649|NCT00174941|B2|Baseline|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level
1226650|NCT00174941|B1|Baseline|Febuxostat 40 mg QD|Febuxostat 40 mg orally, once daily, based on serum urate level.
1226651|NCT00174941|P4|Participant Flow|Total Febuxostat|
1226652|NCT00174941|P3|Participant Flow|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
1226653|NCT00174941|P2|Participant Flow|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
1226654|NCT00174941|P1|Participant Flow|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
1226655|NCT00174941|O4|Outcome|Total Febuxostat|
1226656|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
1226657|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
1226658|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
1226659|NCT00174941|O4|Outcome|Total Febuxostat|
1226660|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
1226661|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
1226662|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
1226663|NCT00174941|O4|Outcome|Total Febuxostat|
1226664|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
1226665|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
1226666|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
1226667|NCT00174941|O4|Outcome|Total Febuxostat|
1226668|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
1226669|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
1226670|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
1226671|NCT00174941|O4|Outcome|Total Febuxostat|
1226672|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
1226673|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
1226674|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
1226675|NCT00174941|O4|Outcome|Total Febuxostat|
1226676|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
1226677|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
1226678|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
1226679|NCT00174941|O4|Outcome|Total Febuxostat|
1226680|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
1226681|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
1226682|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
1226683|NCT00174941|O4|Outcome|Total Febuxostat|
1226684|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
1226685|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
1226686|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
1226687|NCT00174941|O4|Outcome|Total Febuxostat|
1226688|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
1226689|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
1226690|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
1226691|NCT00174941|O4|Outcome|Total Febuxostat|
1226692|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
1226693|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
1226694|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
1226695|NCT00174941|O4|Outcome|Total Febuxostat|
1226696|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
1226697|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
1226698|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
1226699|NCT00174941|O4|Outcome|Total Febuxostat|
1226700|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
1226701|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
1226702|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
1226703|NCT00174941|O4|Outcome|Total Febuxostat|
1226704|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
1226705|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
1226706|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
1226707|NCT00174941|O4|Outcome|Total Febuxostat|
1226708|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
1226709|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
1226710|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
1226711|NCT00174941|O4|Outcome|Total Febuxostat|
1226712|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
1226713|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
1226714|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
1226715|NCT00174941|O4|Outcome|Total Febuxostat|
1226716|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
1226717|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
1226718|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
1226719|NCT00174941|E4|Reported Event|Febuxostat Total|
1226720|NCT00174941|E3|Reported Event|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily, based on serum urate level
1226721|NCT00174941|E2|Reported Event|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily, based on serum urate level
1226722|NCT00174941|E1|Reported Event|Febuxostat 40 mg QD|Febuxostat 40 mg taken orally, once daily, based on serum urate level.
1226723|NCT00174915|B6|Baseline|Total|Total of all reporting groups
1226724|NCT00174915|B5|Baseline|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
1226725|NCT00174915|B4|Baseline|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
1226726|NCT00174915|B3|Baseline|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
1226727|NCT00174915|B2|Baseline|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
1226728|NCT00174915|B1|Baseline|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
1226729|NCT00174915|P5|Participant Flow|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
1226730|NCT00174915|P4|Participant Flow|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
1226731|NCT00174915|P3|Participant Flow|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
1226732|NCT00174915|P2|Participant Flow|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
1226733|NCT00174915|P1|Participant Flow|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
1226734|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
1226735|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
1226736|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
1226737|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
1226738|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
1226739|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
1226954|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
1226740|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
1226741|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
1226742|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
1226743|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
1226744|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
1226745|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
1226746|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
1226747|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
1226748|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
1226749|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
1226750|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
1226751|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
1226752|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
1226753|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
1226754|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
1226755|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
1226756|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
1226757|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
1226758|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
1226759|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
1226760|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
1226761|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
1226762|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
1226763|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
1226764|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
1226765|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
1226766|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
1226767|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
1226768|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
1226769|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
1226770|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
1226771|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
1226772|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
1226773|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
1226774|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
1226775|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
1226776|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
1226777|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
1226778|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
1226779|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
1226780|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
1226781|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
1226782|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
1226783|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
1226784|NCT00174915|E5|Reported Event|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
1226955|NCT00174252|E1|Reported Event|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
1226785|NCT00174915|E4|Reported Event|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
1226786|NCT00174915|E3|Reported Event|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
1226787|NCT00174915|E2|Reported Event|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
1226788|NCT00174915|E1|Reported Event|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
1226789|NCT00174785|B3|Baseline|Total|Total of all reporting groups
1226790|NCT00174785|B2|Baseline|Placebo|matching placebo tablets
1226791|NCT00174785|B1|Baseline|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
1226792|NCT00174785|P2|Participant Flow|Placebo|matching placebo tablets
1226793|NCT00174785|P1|Participant Flow|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
1226794|NCT00174785|O2|Outcome|Placebo|matching placebo tablets
1226795|NCT00174785|O1|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
1226796|NCT00174785|O2|Outcome|Placebo|matching placebo tablets
1226797|NCT00174785|O1|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
1226798|NCT00174785|O2|Outcome|Placebo|matching placebo tablets
1226799|NCT00174785|O1|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
1226800|NCT00174785|O2|Outcome|Placebo|matching placebo tablets
1226801|NCT00174785|O1|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
1226802|NCT00174785|O2|Outcome|Placebo|matching placebo tablets
1226803|NCT00174785|O1|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
1226804|NCT00174785|E2|Reported Event|Placebo|matching placebo tablets
1226805|NCT00174785|E1|Reported Event|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
1226806|NCT00174460|B3|Baseline|Total|Total of all reporting groups
1226807|NCT00174460|B2|Baseline|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
1226808|NCT00174460|B1|Baseline|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
1226809|NCT00174460|P2|Participant Flow|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
1226810|NCT00174460|P1|Participant Flow|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
1226811|NCT00174460|O1|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
1226812|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
1226813|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
1226814|NCT00174460|O1|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
1226815|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
1226816|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
1226817|NCT00174460|O1|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
1226818|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
1226819|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
1226820|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
1226821|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
1226956|NCT00174187|B3|Baseline|Total|Total of all reporting groups
1226822|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
1227042|NCT00171704|E2|Reported Event|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
1226823|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
1226824|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
1226825|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
1226826|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
1226827|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
1226828|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
1226829|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
1226830|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
1226831|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
1226832|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
1226833|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
1226834|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
1226835|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
1226836|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
1226837|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
1226838|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
1226839|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
1226840|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
1226841|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
1226842|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
1226843|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
1226844|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
1227442|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1226874|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
1226845|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
1226846|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
1226847|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
1226848|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
1226849|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
1226850|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
1226851|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
1226852|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
1226853|NCT00174460|E2|Reported Event|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
1226854|NCT00174460|E1|Reported Event|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
1226855|NCT00174447|B1|Baseline|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
1226856|NCT00174447|P1|Participant Flow|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
1226857|NCT00174447|O1|Outcome|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
1226858|NCT00174447|O1|Outcome|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
1226859|NCT00174447|O1|Outcome|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
1226860|NCT00174447|O1|Outcome|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
1226861|NCT00174447|O1|Outcome|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
1226862|NCT00174447|O1|Outcome|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
1226863|NCT00174447|E1|Reported Event|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
1226864|NCT00174382|B1|Baseline|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
1226865|NCT00174382|P1|Participant Flow|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
1226866|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
1226867|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
1226868|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
1226869|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
1226870|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
1226871|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
1226872|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
1226873|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
1227036|NCT00171704|O2|Outcome|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
1226875|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
1226876|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
1226877|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
1226878|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
1226879|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
1226880|NCT00174382|E1|Reported Event|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
1226881|NCT00174291|B3|Baseline|Total|Total of all reporting groups
1226882|NCT00174291|B2|Baseline|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1226883|NCT00174291|B1|Baseline|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1226884|NCT00174291|P2|Participant Flow|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1226885|NCT00174291|P1|Participant Flow|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1226886|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1226957|NCT00174187|B2|Baseline|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1227037|NCT00171704|O1|Outcome|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
1227038|NCT00171704|O2|Outcome|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
1227039|NCT00171704|O1|Outcome|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
1227040|NCT00171704|O2|Outcome|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
1227041|NCT00171704|O1|Outcome|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
1241711|NCT00116168|P2|Participant Flow|MEDI-528 1 mg|
1226887|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1226888|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1226889|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1226890|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1226891|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1226892|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1226893|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1226894|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1227896|NCT00168454|B6|Baseline|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
1226895|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1226896|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1226897|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1226898|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1226899|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1226900|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1226901|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1226902|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1227897|NCT00168454|B5|Baseline|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
1226903|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1226904|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1226905|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1226906|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1226907|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1226908|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1226909|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1226910|NCT00174291|E2|Reported Event|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1227898|NCT00168454|B4|Baseline|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
1226911|NCT00174291|E1|Reported Event|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1226912|NCT00174265|B3|Baseline|Total|Total of all reporting groups
1226913|NCT00174265|B2|Baseline|Olanzapine|5-20 mg by mouth once daily for 26 weeks
1226914|NCT00174265|B1|Baseline|Asenapine|5-10 mg sublingually twice daily for 26 weeks
1226915|NCT00174265|P2|Participant Flow|Olanzapine|5-20 mg by mouth once daily for 26 weeks
1226916|NCT00174265|P1|Participant Flow|Asenapine|5-10 mg sublingually twice daily for 26 weeks
1226917|NCT00174265|O2|Outcome|Olanzapine|5-20 mg by mouth once daily for 26 weeks
1226918|NCT00174265|O1|Outcome|Asenapine|5-10 mg sublingually twice daily for 26 weeks
1226919|NCT00174265|O2|Outcome|Olanzapine|5-20 mg by mouth once daily for 26 weeks
1226920|NCT00174265|O1|Outcome|Asenapine|5-10 mg sublingually twice daily for 26 weeks
1226921|NCT00174265|E2|Reported Event|Olanzapine|5-20 mg by mouth once daily for 26 weeks
1226922|NCT00174265|E1|Reported Event|Asenapine|5-10 mg sublingually twice daily for 26 weeks
1226923|NCT00174252|B1|Baseline|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
1226924|NCT00174252|P1|Participant Flow|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
1226925|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
1226926|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
1226927|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
1226928|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
1226929|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
1226930|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
1226931|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
1226932|NCT00174252|O2|Outcome|Genotonorm (IGF-1 > 2 SD at 9 and 12 Months)|
1226933|NCT00174252|O1|Outcome|Genotonorm (IGF-1 < = 2 SD at 9 or 12 Months)|
1226934|NCT00174252|O2|Outcome|Genotonorm (IGF-1 > 2 SD at 9 and 12 Months)|
1226935|NCT00174252|O1|Outcome|Genotonorm (IGF-1 < = 2 SD at 9 or 12 Months)|
1226936|NCT00174252|O2|Outcome|Genotonorm (IGF-1 > 2 SD at 9 and 12 Months)|
1226937|NCT00174252|O1|Outcome|Genotonorm (IGF-1 < = 2 SD at 9 or 12 Months)|
1226938|NCT00174252|O2|Outcome|Genotonorm (IGF-1 > 2 SD at 9 and 12 Months)|
1226939|NCT00174252|O1|Outcome|Genotonorm (IGF-1 < = 2 SD at 9 or 12 Months)|
1226940|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
1226941|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
1226942|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
1226943|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
1226944|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
1226945|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
1226946|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
1226947|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
1226948|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
1226949|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
1226950|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
1226951|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
1226952|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
1226953|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
1234686|NCT00138671|O1|Outcome|Inhaled Insulin|
1226958|NCT00174187|B1|Baseline|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226959|NCT00174187|P3|Participant Flow|Somatropin- After Year 3|Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1226960|NCT00174187|P2|Participant Flow|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226961|NCT00174187|P1|Participant Flow|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226962|NCT00174187|O1|Outcome|Somatropin- After Year 3|Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1226963|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226964|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226965|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226966|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226967|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226968|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226969|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226970|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226971|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226972|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226973|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1227034|NCT00171704|O2|Outcome|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
1227035|NCT00171704|O1|Outcome|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
1226974|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226975|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226976|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226977|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226978|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226979|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226980|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226981|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226982|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226983|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226984|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226985|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226986|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226987|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226988|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226989|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226990|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226991|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226992|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226993|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226994|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226995|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226996|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226997|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226998|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1226999|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1227000|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1227001|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1227002|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1227003|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1227004|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1227005|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1227006|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1227007|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1227008|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1227009|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1227010|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1227011|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1227012|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1227013|NCT00174187|O1|Outcome|Somatropin- After Year 3|Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1227014|NCT00174187|O1|Outcome|Somatropin- After Year 3|Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1227015|NCT00174187|O1|Outcome|Somatropin- After Year 3|Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1227016|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1227017|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1227018|NCT00174187|E3|Reported Event|Somatropin- After Year 3|Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
1227019|NCT00174187|E2|Reported Event|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1227020|NCT00174187|E1|Reported Event|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
1227021|NCT00171704|B3|Baseline|Total|Total of all reporting groups
1227022|NCT00171704|B2|Baseline|Tam-Let|Tamoxifen 20 mg once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
1227023|NCT00171704|B1|Baseline|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
1227024|NCT00171704|P2|Participant Flow|Tam-Let|Tamoxifen 20 mg once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
1227025|NCT00171704|P1|Participant Flow|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
1227026|NCT00171704|O2|Outcome|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
1227027|NCT00171704|O1|Outcome|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
1227028|NCT00171704|O2|Outcome|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
1227029|NCT00171704|O1|Outcome|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
1227030|NCT00171704|O2|Outcome|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
1227031|NCT00171704|O1|Outcome|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
1227032|NCT00171704|O2|Outcome|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
1227033|NCT00171704|O1|Outcome|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
1238622|NCT00124982|B3|Baseline|Total|Total of all reporting groups
1227043|NCT00171704|E1|Reported Event|Letrozole|2.5 mg once daily q.d. orally for 5 years
1227044|NCT00171340|B3|Baseline|Total|Total of all reporting groups
1227045|NCT00171340|B2|Baseline|Zoledronic Acid 4 mg Delayed|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
1227046|NCT00171340|B1|Baseline|Zoledronic Acid 4 mg Upfront|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
1227047|NCT00171340|P2|Participant Flow|Zoledronic Acid 4 mg Delayed|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
1227048|NCT00171340|P1|Participant Flow|Zoledronic Acid 4 mg Upfront|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
1227049|NCT00171340|O2|Outcome|Zoledronic Acid 4 mg Delayed|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
1227050|NCT00171340|O1|Outcome|Zoledronic Acid 4 mg Upfront|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
1227051|NCT00171340|O2|Outcome|Zolendronic Acid 4 mg Delayed|
1227052|NCT00171340|O1|Outcome|Zolendronic Acid 4 mg Upfront|
1227053|NCT00171340|O2|Outcome|Zolendronic Acid 4 mg Delayed|
1227054|NCT00171340|O1|Outcome|Zolendronic Acid 4 mg Upfront|
1227055|NCT00171340|O2|Outcome|Zolendronic Acid 4 mg Delayed|
1227056|NCT00171340|O1|Outcome|Zolendronic Acid 4 mg Upfront|
1227057|NCT00171340|O2|Outcome|Zoledronic Acid 4 mg Delayed|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
1227058|NCT00171340|O1|Outcome|Zoledronic Acid 4 mg Upfront|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
1227059|NCT00171340|E2|Reported Event|Zolendronic Acid 4mg Delayed|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
1227060|NCT00171340|E1|Reported Event|Zoledronic Acid 4mg Upfront|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1 and Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
1227061|NCT00171314|B3|Baseline|Total|Total of all reporting groups
1227062|NCT00171314|B2|Baseline|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
1227063|NCT00171314|B1|Baseline|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
1227064|NCT00171314|P2|Participant Flow|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
1227065|NCT00171314|P1|Participant Flow|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
1227066|NCT00171314|O2|Outcome|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
1227067|NCT00171314|O1|Outcome|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
1227068|NCT00171314|O2|Outcome|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
1227069|NCT00171314|O1|Outcome|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
1227443|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227070|NCT00171314|O2|Outcome|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
1227071|NCT00171314|O1|Outcome|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
1227072|NCT00171314|O2|Outcome|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
1227073|NCT00171314|O1|Outcome|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
1227074|NCT00171314|O2|Outcome|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
1227075|NCT00171314|O1|Outcome|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
1227076|NCT00171314|E2|Reported Event|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
1227077|NCT00171314|E1|Reported Event|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1
1227078|NCT00171301|B3|Baseline|Total|Total of all reporting groups
1227079|NCT00171301|B2|Baseline|Deferasirox (16 Years or Older)|Participants age 16 years or older received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient’s body weight.
1227080|NCT00171301|B1|Baseline|Deferasirox (Between 2 <16 Years )|Participants age 2 years up to 16 years received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient’s body weight.
1227081|NCT00171301|P2|Participant Flow|Deferasirox (16 Years or Older)|Participants age 16 years or older received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient’s body weight.
1227082|NCT00171301|P1|Participant Flow|Deferasirox (Between 2 <16 Years )|Participants age 2 years up to 16 years received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient’s body weight.
1227083|NCT00171301|O1|Outcome|Deferasirox (All Participants)|Participants received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
1227084|NCT00171301|O2|Outcome|Deferasirox (16 Years or Older)|Participants age 16 years or older received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
1227085|NCT00171301|O1|Outcome|Deferasirox (Between 2 <16 Years)|Participants age 2 years up to 16 years received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
1227086|NCT00171301|O2|Outcome|Deferasirox (16 Years or Older)|Participants age 16 years or older received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
1227087|NCT00171301|O1|Outcome|Deferasirox (Between 2 <16 Years)|Participants age 2 years up to 16 years received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
1227088|NCT00171301|O2|Outcome|Deferasirox (16 Years or Older)|Participants age 16 years or older received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
1227089|NCT00171301|O1|Outcome|Deferasirox (Between 2 <16 Years)|Participants age 2 years up to 16 years received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
1227127|NCT00172042|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
1227090|NCT00171301|E2|Reported Event|Deferasirox (16 Years or Older)|Participants age 16 years and older received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient’s body weight.
1227091|NCT00171301|E1|Reported Event|Deferasirox (Between 2 <16 Years)|Participants age 2 years up to 16 years received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient’s body weight.
1227092|NCT00172185|B5|Baseline|Total|Total of all reporting groups
1227093|NCT00172185|B4|Baseline|0.10/0.10|Received Teduglutide 0.10 mg/kg/d in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
1227094|NCT00172185|B3|Baseline|0.05/0.05|Received Teduglutide 0.05 mg/kg/d in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
1227095|NCT00172185|B2|Baseline|Placebo/0.10|Received placebo in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
1227096|NCT00172185|B1|Baseline|Placebo/0.05|Received placebo in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
1227097|NCT00172185|P4|Participant Flow|0.10/0.10|Received Teduglutide 0.10 mg/kg/d in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
1227098|NCT00172185|P3|Participant Flow|0.05/0.05|Received Teduglutide 0.05 mg/kg/d in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
1227099|NCT00172185|P2|Participant Flow|Placebo/0.10|Received placebo in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
1227100|NCT00172185|P1|Participant Flow|Placebo/0.05|Received placebo in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
1227101|NCT00172185|O4|Outcome|0.10/0.10|Received teduglutide 0.10 mg/kg/d in Study 004/ Received teduglutide 0.10 mg/kg/d in Study 005
1227102|NCT00172185|O3|Outcome|0.05/0.05|Received teduglutide 0.05 mg/kg/d in Study 004/ Received teduglutide 0.05 mg/kg/d in Study 005
1227103|NCT00172185|O2|Outcome|Placebo/0.10|Received placebo in Study 004/ Received teduglutide 0.10 mg/kg/d in Study 005
1227104|NCT00172185|O1|Outcome|Placebo/0.05|Received placebo in Study 004/ Received teduglutide 0.05 mg/kg/d in Study 005
1227105|NCT00172185|O4|Outcome|0.10/0.10|Received Teduglutide 0.10 mg/kg/d in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
1227106|NCT00172185|O3|Outcome|0.05/0.05|Received Teduglutide 0.05 mg/kg/d in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
1227107|NCT00172185|O2|Outcome|Placebo/0.10|Received placebo in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
1227108|NCT00172185|O1|Outcome|Placebo/0.05|Received placebo in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
1227109|NCT00172185|E4|Reported Event|0.10/0.10|Received teduglutide 0.10 mg/kg/d in Study 004/ Received teduglutide 0.10 mg/kg/d in Study 005
1227110|NCT00172185|E3|Reported Event|0.05/0.05|Received teduglutide 0.05 mg/kg/d in Study 004/ Received teduglutide 0.05 mg/kg/d in Study 005
1227111|NCT00172185|E2|Reported Event|Placebo/0.10|Received placebo in Study 004/ Received teduglutide 0.10 mg/kg/d in Study 005
1227112|NCT00172185|E1|Reported Event|Placebo/0.05|Received placebo in Study 004/ Received teduglutide 0.05 mg/kg/d in Study 005
1227113|NCT00172042|B3|Baseline|Total|Total of all reporting groups
1227114|NCT00172042|B2|Baseline|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
1227115|NCT00172042|B1|Baseline|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
1227116|NCT00172042|P2|Participant Flow|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
1227117|NCT00172042|P1|Participant Flow|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
1227118|NCT00172042|O2|Outcome|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
1227119|NCT00172042|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
1227120|NCT00172042|O2|Outcome|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
1227121|NCT00172042|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
1227122|NCT00172042|O2|Outcome|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
1227123|NCT00172042|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
1227124|NCT00172042|O2|Outcome|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
1227125|NCT00172042|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
1227126|NCT00172042|O2|Outcome|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
1227891|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
1227128|NCT00172042|O2|Outcome|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
1227900|NCT00168454|B2|Baseline|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
1227129|NCT00172042|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
1227130|NCT00172042|O2|Outcome|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
1227131|NCT00172042|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
1227132|NCT00172042|O2|Outcome|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
1227133|NCT00172042|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
1227134|NCT00172042|E2|Reported Event|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
1227135|NCT00172042|E1|Reported Event|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
1227136|NCT00171925|B3|Baseline|Total|Total of all reporting groups
1227137|NCT00171925|B2|Baseline|Control|No Treatment with study medication.
1227138|NCT00171925|B1|Baseline|Zoledronic Acid (ZOL446)|Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
1227139|NCT00171925|P2|Participant Flow|Control|No Treatment with study medication.
1227140|NCT00171925|P1|Participant Flow|Zoledronic Acid (ZOL446)|Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
1227141|NCT00171925|O2|Outcome|Control|No Treatment with study medication.
1227142|NCT00171925|O1|Outcome|Zoledronic Acid (ZOL446)|Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
1227143|NCT00171925|O2|Outcome|Control|No Treatment with study medication.
1227144|NCT00171925|O1|Outcome|Zoledronic Acid (ZOL446)|Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
1227145|NCT00171925|O2|Outcome|Control|No Treatment with study medication.
1227146|NCT00171925|O1|Outcome|Zoledronic Acid (ZOL446)|Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
1227147|NCT00171925|E2|Reported Event|Control|No treatment with study medication.
1227148|NCT00171925|E1|Reported Event|Zoledronic Acid|Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
1227149|NCT00171873|B3|Baseline|Total|Total of all reporting groups
1227150|NCT00171873|B2|Baseline|Placebo|Sodium chloride intramuscularly every 28 days
1227151|NCT00171873|B1|Baseline|Octreotide LAR (SMS995)|Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days
1227152|NCT00171873|P2|Participant Flow|Placebo|Sodium chloride intramuscularly every 28 days
1227153|NCT00171873|P1|Participant Flow|Octreotide LAR (SMS995)|Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days
1227154|NCT00171873|O2|Outcome|Placebo|Sodium chloride intramuscularly every 28 days
1227155|NCT00171873|O1|Outcome|Octreotide LAR (SMS995)|Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days
1227156|NCT00171873|E2|Reported Event|Placebo|Sodium chloride intramuscularly every 28 days
1227157|NCT00171873|E1|Reported Event|Octreotide LAR (SMS995)|Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days
1227158|NCT00171834|B8|Baseline|Total|Total of all reporting groups
1227159|NCT00171834|B7|Baseline|Patupilone 10 mg/m^2 (Phase II) NSCLC w.BM Cohort|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
1227160|NCT00171834|B6|Baseline|Patupilone 10 mg/m^2 (Phase II) NSCLC Cohort|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
1227161|NCT00171834|B5|Baseline|Patupilone 12.0-13.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
1227162|NCT00171834|B4|Baseline|Patupilone 10.0-11.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
1227163|NCT00171834|B3|Baseline|Patupilone 8.5-9.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
1227164|NCT00171834|B2|Baseline|Patupilone 7.5-8.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
1227165|NCT00171834|B1|Baseline|Patupilone ≤7.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
1227166|NCT00171834|P7|Participant Flow|Patupilone 10 mg/m^2 (Phase II) NSCLC w.BM Cohort|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
1227167|NCT00171834|P6|Participant Flow|Patupilone 10 mg/m^2 (Phase II) NSCLC Cohort|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
1227267|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
1227168|NCT00171834|P5|Participant Flow|Patupilone 12.0-13.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
1227169|NCT00171834|P4|Participant Flow|Patupilone 10.0-11.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
1227170|NCT00171834|P3|Participant Flow|Patupilone 8.5-9.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
1227171|NCT00171834|P2|Participant Flow|Patupilone 7.5-8.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
1227172|NCT00171834|P1|Participant Flow|Patupilone ≤7.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
1227173|NCT00171834|O2|Outcome|Patupilone (EPO906) Phase II|
1227174|NCT00171834|O1|Outcome|Patupilone (EPO906) Phase I|
1227175|NCT00171834|O2|Outcome|Patupilone (EPO906) Phase II|
1227176|NCT00171834|O1|Outcome|Patupilone (EPO906) Phase I|
1227177|NCT00171834|O2|Outcome|Patupilone (EPO906) Phase II|
1227178|NCT00171834|O1|Outcome|Patupilone (EPO906) Phase I|
1227179|NCT00171834|O1|Outcome|Patupilone 10 mg/m^2 (Phase II) NSCLC Cohort|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
1227180|NCT00171834|O13|Outcome|Patupilone 13.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
1227181|NCT00171834|O12|Outcome|Patupilone 12.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
1227182|NCT00171834|O11|Outcome|Patupilone 11.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
1227183|NCT00171834|O10|Outcome|Patupilone 11.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
1227184|NCT00171834|O9|Outcome|Patupilone 10.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
1227185|NCT00171834|O8|Outcome|Patupilone 10.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
1227186|NCT00171834|O7|Outcome|Patupilone 9.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
1227187|NCT00171834|O6|Outcome|Patupilone 9.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
1227188|NCT00171834|O5|Outcome|Patupilone 8.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
1227189|NCT00171834|O4|Outcome|Patupilone 8.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
1227190|NCT00171834|O3|Outcome|Patupilone 7.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
1227191|NCT00171834|O2|Outcome|Patupilone 7.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
1227192|NCT00171834|O1|Outcome|Patupilone 6.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
1227193|NCT00171834|O2|Outcome|Patupilone (EPO906) Phase II|
1227194|NCT00171834|O1|Outcome|Patupilone (EPO906) Phase I|
1227195|NCT00171834|O2|Outcome|Patupilone (EPO906) Phase II|
1227196|NCT00171834|O1|Outcome|Patupilone (EPO906) Phase I|
1227197|NCT00171834|O5|Outcome|Patupilone 12.0-13.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
1227198|NCT00171834|O4|Outcome|Patupilone 10.0-11.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
1227199|NCT00171834|O3|Outcome|Patupilone 8.5-9.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
1227200|NCT00171834|O2|Outcome|Patupilone 7.5-8.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
1227201|NCT00171834|O1|Outcome|Patupilone ≤7.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
1227300|NCT00170846|O2|Outcome|Group B : CNI Withdrawal|Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus (RAD001) 4 mg initial daily dose.
1227202|NCT00171834|E7|Reported Event|Patupilone 10 mg/m^2 (Phase II) NSCLC w. Brain Metastases (BM)|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
1227203|NCT00171834|E6|Reported Event|Patupilone 10 mg/m^2 (Phase II) NSCLC Cohort|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
1227204|NCT00171834|E5|Reported Event|Patupilone 12.0-13.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
1227205|NCT00171834|E4|Reported Event|Patupilone 10.0-11.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
1227206|NCT00171834|E3|Reported Event|Patupilone 8.5-9.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
1227207|NCT00171834|E2|Reported Event|Patupilone 7.5-8.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
1227208|NCT00171834|E1|Reported Event|Patupilone ≤7.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
1227209|NCT00171210|B3|Baseline|Total|Total of all reporting groups
1227210|NCT00171210|B2|Baseline|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
1227211|NCT00171210|B1|Baseline|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
1227212|NCT00171210|P2|Participant Flow|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
1227213|NCT00171210|P1|Participant Flow|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
1227214|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
1227215|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
1227216|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
1227217|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
1227218|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
1227219|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
1227220|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
1227221|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
1227222|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
1227223|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
1227224|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
1227225|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
1227226|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
1227227|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
1227228|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
1227229|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
1227230|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
1227231|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
1227232|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
1227233|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
1227234|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
1227235|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
1227236|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
1227237|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
1227238|NCT00171210|E2|Reported Event|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
1227239|NCT00171210|E1|Reported Event|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study continued this treatment in the extension study. Dosage based on body weight.
1227240|NCT00171054|B3|Baseline|Total|Total of all reporting groups
1227241|NCT00171054|B2|Baseline|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
1227242|NCT00171054|B1|Baseline|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
1227243|NCT00171054|P2|Participant Flow|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
1227244|NCT00171054|P1|Participant Flow|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
1227245|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
1227246|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
1227247|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
1227248|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
1227249|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
1227250|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
1227251|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
1227252|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
1227253|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
1227254|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
1227255|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
1227256|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
1227257|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
1227258|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
1227259|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
1227260|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
1227261|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
1227262|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
1227263|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
1227264|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
1227265|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
1227266|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
1227301|NCT00170846|O1|Outcome|Group A: No RAD|Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
1227268|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
1227269|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
1227270|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
1227271|NCT00171054|E2|Reported Event|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
1227272|NCT00171054|E1|Reported Event|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
1227273|NCT00170950|B3|Baseline|Total|Total of all reporting groups
1227274|NCT00170950|B2|Baseline|Benazepril/Hydrochlorothiazide|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
1227275|NCT00170950|B1|Baseline|Benazepril/Amlodipine|Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
1227276|NCT00170950|P2|Participant Flow|Benazepril/Hydrochlorothiazide|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
1227277|NCT00170950|P1|Participant Flow|Benazepril/Amlodipine|Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
1227278|NCT00170950|O2|Outcome|Benazepril/Hydrochlorothiazide|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
1227279|NCT00170950|O1|Outcome|Benazepril/Amlodipine|Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
1227280|NCT00170950|O2|Outcome|Benazepril/Hydrochlorothiazide|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
1227281|NCT00170950|O1|Outcome|Benazepril/Amlodipine|Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
1227282|NCT00170950|O2|Outcome|Benazepril/Hydrochlorothiazide|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
1227283|NCT00170950|O1|Outcome|Benazepril/Amlodipine|Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
1227284|NCT00170950|E2|Reported Event|Benazepril / HCTZ|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1), 40/12.5 mg (Dose Level 2), and 40/25 mg (Dose Level 3) capsules for oral administration once daily
1227285|NCT00170950|E1|Reported Event|Benazepril / Amlodipine|Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1), 40/5 mg (Dose Level 2), and 40/10 mg (Dose Level 3) capsules for oral administration once daily
1227286|NCT00170846|B4|Baseline|Total|Total of all reporting groups
1227287|NCT00170846|B3|Baseline|Group C: CNI Reduction|Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
1227288|NCT00170846|B2|Baseline|Group B : CNI Withdrawal|Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus (RAD001) 4 mg initial daily dose.
1227289|NCT00170846|B1|Baseline|Group A: No RAD|Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
1227290|NCT00170846|P3|Participant Flow|Group C: CNI Reduction|Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
1227291|NCT00170846|P2|Participant Flow|Group B : CNI Withdrawal|Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus (RAD001) 4 mg initial daily dose.
1227292|NCT00170846|P1|Participant Flow|Group A: No RAD|Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
1227293|NCT00170846|O3|Outcome|Group C: CNI Reduction|Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
1227294|NCT00170846|O2|Outcome|Group B : CNI Withdrawal|Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus (RAD001) 4 mg initial daily dose.
1227295|NCT00170846|O1|Outcome|Group A: No RAD|Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
1227296|NCT00170846|O3|Outcome|Group C: CNI Reduction|Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
1227297|NCT00170846|O2|Outcome|Group B : CNI Withdrawal|Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus (RAD001) 4 mg initial daily dose.
1227298|NCT00170846|O1|Outcome|Group A: No RAD|Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
1227299|NCT00170846|O3|Outcome|Group C: CNI Reduction|Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
1227892|NCT00168805|E3|Reported Event|Enoxaparin|40mg qd (once daily) subcutaneous
1227302|NCT00170846|E3|Reported Event|Group C: CNI Reduction|Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
1227303|NCT00170846|E2|Reported Event|Group B : CNI Withdrawal|Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus (RAD001) 4 mg initial daily dose.
1227304|NCT00170846|E1|Reported Event|Group A: No RAD|Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
1227305|NCT00170625|B1|Baseline|Hycamtin|Topotecan 1mg/m2/d on day 1-3, q 21d
1227306|NCT00170625|P1|Participant Flow|Hycamtin|Topotecan 1mg/m2/d on day 1-3, q 21 Carboplatin AUC 5 on day 3, q 21
1227307|NCT00170625|O1|Outcome|Hycamtin|Topotecan 1mg/m2/d on day 1-3, q 21d
1227308|NCT00170625|O1|Outcome|Hycamtin|Topotecan 1mg/m2/d on day 1-3, q 21d
1227309|NCT00170625|E1|Reported Event|Hycamtin|Topotecan 1mg/m2/d on day 1-3, q 21d
1227310|NCT00170157|B1|Baseline|Entire Study Population|All participants initially randomized.
1227311|NCT00170157|P2|Participant Flow|Androgen Ablative (AA) Then AA Therapy + MDX-010|"3 months of initial AA therapy alone~Androgen ablative (AA) therapy is received a combined regimen of GnRH agonist and androgen receptor blocker. GnRH agonists must be in the form of a 1 month depot of either leuprolide acetate (Lupron) 7.5 mg intramuscular (IM), or goserelin acetate (Zoladex) 3.6 mg subcutaneous (SC) and will be administered on Day 0 (baseline), Day 28 and Day 56. Androgen receptor blockade may be provided by oral administration of either flutamide (Eulexin) 250 mg orally 3 times daily, or bicalutamide (Casodex) 50 mg orally once daily."
1227312|NCT00170157|P1|Participant Flow|Androgen Ablative (AA) Therapy + MDX-010|"3 months of concurrent androgen ablative (AA) therapy + MDX-010~Androgen ablative (AA) therapy is received a combined regimen of GnRH agonist and androgen receptor blocker. GnRH agonists must be in the form of a 1 month depot of either leuprolide acetate (Lupron) 7.5 mg intramuscular (IM), or goserelin acetate (Zoladex) 3.6 mg subcutaneous (SC) and will be administered on Day 0 (baseline), Day 28 and Day 56. Androgen receptor blockade may be provided by oral administration of either flutamide (Eulexin) 250 mg orally 3 times daily, or bicalutamide (Casodex) 50 mg orally once daily.~MDX-010 is received as an infusion at a dose of 3.0 mg/kg on day 7."
1227313|NCT00170157|O2|Outcome|Androgen Ablative (AA) Then AA Therapy + MDX-010|"3 months of initial AA therapy alone~Androgen ablative (AA) therapy is received a combined regimen of GnRH agonist and androgen receptor blocker. GnRH agonists must be in the form of a 1 month depot of either leuprolide acetate (Lupron) 7.5 mg intramuscular (IM), or goserelin acetate (Zoladex) 3.6 mg subcutaneous (SC) and will be administered on Day 0 (baseline), Day 28 and Day 56. Androgen receptor blockade may be provided by oral administration of either flutamide (Eulexin) 250 mg orally 3 times daily, or bicalutamide (Casodex) 50 mg orally once daily"
1227314|NCT00170157|O1|Outcome|Androgen Ablative (AA) Therapy + MDX-010|"3 months of concurrent androgen ablative (AA) therapy + MDX-010~Androgen ablative (AA) therapy is received a combined regimen of GnRH agonist and androgen receptor blocker. GnRH agonists must be in the form of a 1 month depot of either leuprolide acetate (Lupron) 7.5 mg intramuscular (IM), or goserelin acetate (Zoladex) 3.6 mg subcutaneous (SC) and will be administered on Day 0 (baseline), Day 28 and Day 56. Androgen receptor blockade may be provided by oral administration of either flutamide (Eulexin) 250 mg orally 3 times daily, or bicalutamide (Casodex) 50 mg orally once daily.~MDX-010 is received as an infusion at a dose of 3.0 mg/kg on day 7."
1227315|NCT00170157|O1|Outcome|Entire Study Population|All participants (Androgen ablative (AA) therapy + MDX-010 and Androgen ablative (AA) therapy alone) initially randomized (i.e., before cross-over) were grouped together for this outcome.
1227316|NCT00170157|E1|Reported Event|Entire Study Population|All participants (Androgen ablative (AA) therapy + MDX-010 and Androgen ablative (AA) therapy alone the AA Therapy + MDX-010) were grouped together for this outcome.
1227317|NCT00169442|B7|Baseline|Total|Total of all reporting groups
1227318|NCT00169442|B6|Baseline|PRP Tritanrix-HepB Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227319|NCT00169442|B5|Baseline|PRP Tritanrix-HepB Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227320|NCT00169442|B4|Baseline|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
1227321|NCT00169442|B3|Baseline|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227322|NCT00169442|B2|Baseline|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227323|NCT00169442|B1|Baseline|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227324|NCT00169442|P6|Participant Flow|PRP Tritanrix-HepB Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received plain Polyribosil-Ribitol-Phosphate (PRP) polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227325|NCT00169442|P5|Participant Flow|PRP Tritanrix-HepB Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received plain Polyribosil-Ribitol-Phosphate (PRP) polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227444|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227326|NCT00169442|P4|Participant Flow|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
1227327|NCT00169442|P3|Participant Flow|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227328|NCT00169442|P2|Participant Flow|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227329|NCT00169442|P1|Participant Flow|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227330|NCT00169442|O3|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
1227331|NCT00169442|O2|Outcome|Mix Pooled Group|Tritanrix-HepB/Hiberix Kft. Mix Group, HB Tritanrix-HepB/Hiberix Kft. Mix Group and Tritanrix-HepB/Hiberix Kft. Ref Group were pooled into Mix Pooled Group.
1227332|NCT00169442|O1|Outcome|PRP Pooled Group|PRP Tritanrix-HepB Kft. Mix Group and PRP Tritanrix-HepB Kft. Ref Group were pooled into PRP Pooled Group.
1227333|NCT00169442|O3|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
1227334|NCT00169442|O2|Outcome|Mix Pooled Group|Tritanrix-HepB/Hiberix Kft. Mix Group, HB Tritanrix-HepB/Hiberix Kft. Mix Group and Tritanrix-HepB/Hiberix Kft. Ref Group were pooled into Mix Pooled Group.
1227335|NCT00169442|O1|Outcome|PRP Pooled Group|PRP Tritanrix-HepB Kft. Mix Group and PRP Tritanrix-HepB Kft. Ref Group were pooled into PRP Pooled Group.
1227336|NCT00169442|O3|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
1227337|NCT00169442|O2|Outcome|Mix Pooled Group|Tritanrix-HepB/Hiberix Kft. Mix Group, HB Tritanrix-HepB/Hiberix Kft. Mix Group and Tritanrix-HepB/Hiberix Kft. Ref Group were pooled into Mix Pooled Group.
1227338|NCT00169442|O1|Outcome|PRP Pooled Group|PRP Tritanrix-HepB Kft. Mix Group and PRP Tritanrix-HepB Kft. Ref Group were pooled into PRP Pooled Group.
1227339|NCT00169442|O3|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
1227340|NCT00169442|O2|Outcome|Mix Pooled Group|Tritanrix-HepB/Hiberix Kft. Mix Group, HB Tritanrix-HepB/Hiberix Kft. Mix Group and Tritanrix-HepB/Hiberix Kft. Ref Group were pooled into Mix Pooled Group.
1227341|NCT00169442|O1|Outcome|PRP Pooled Group|PRP Tritanrix-HepB Kft. Mix Group and PRP Tritanrix-HepB Kft. Ref Group were pooled into PRP Pooled Group.
1227342|NCT00169442|O2|Outcome|PRP Tritanrix-HepB Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227343|NCT00169442|O1|Outcome|PRP Tritanrix-HepB Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227344|NCT00169442|O2|Outcome|PRP Tritanrix-HepB Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227345|NCT00169442|O1|Outcome|PRP Tritanrix-HepB Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227346|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
1227347|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227348|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227349|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227893|NCT00168805|E2|Reported Event|Dabigatran 150mg|qd (once daily) oral
1227350|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
1227351|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227352|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227353|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227354|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
1227355|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227356|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227357|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227358|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
1227359|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227360|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227361|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227362|NCT00169442|O2|Outcome|PRP Tritanrix-HepB Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227363|NCT00169442|O1|Outcome|PRP Tritanrix-HepB Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227364|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
1227365|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227366|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227367|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227368|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
1227369|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227370|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227371|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227372|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
1227373|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227374|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227375|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227376|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
1227377|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227378|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227379|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227380|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
1227381|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227382|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227383|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227384|NCT00169442|O2|Outcome|PRP Tritanrix-HepB Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227385|NCT00169442|O1|Outcome|PRP Tritanrix-HepB Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227386|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
1227387|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227388|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227389|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227390|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
1227391|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227392|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227393|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227394|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
1227395|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227396|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227397|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227398|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
1227399|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227400|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227401|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227402|NCT00169442|O2|Outcome|PRP Tritanrix-HepB Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227403|NCT00169442|O1|Outcome|PRP Tritanrix-HepB Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227404|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
1227405|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227406|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227407|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227408|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
1227409|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227410|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227411|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227412|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
1227413|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227414|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227415|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227416|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
1227417|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227418|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227419|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227420|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
1227421|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227422|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227423|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227424|NCT00169442|O4|Outcome|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
1227425|NCT00169442|O3|Outcome|HB Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227426|NCT00169442|O2|Outcome|Tritanrix-HepB/Hiberix Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227427|NCT00169442|O1|Outcome|Tritanrix-HepB/Hiberix Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227428|NCT00169442|O2|Outcome|PRP Tritanrix-HepB Kft. Ref Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227429|NCT00169442|O1|Outcome|PRP Tritanrix-HepB Kft. Mix Group|Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.
1227430|NCT00169442|E5|Reported Event|PRP TRITANRIX-HEPB KFT. REF GROUP|Healthy male and female infants who were primed with Tritanrix ™-HepB/Hiberix™ vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age .
1227431|NCT00169442|E4|Reported Event|PRP TRITANRIX-HEPB KFT. MIX GROUP|Healthy male and female infants who were primed with Tritanrix ™-HepB/Hiberix™ Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age .
1227432|NCT00169442|E3|Reported Event|Tritanrix-HepB Kft.+Hiberix Group|Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.
1227433|NCT00169442|E2|Reported Event|Mix Pooled Group|Tritanrix-HepB/Hiberix Kft. Mix Group, HB Tritanrix-HepB/Hiberix Kft. Mix Group and Tritanrix-HepB/Hiberix Kft. Ref Group were pooled into Mix Pooled Group.
1227434|NCT00169442|E1|Reported Event|PRP Pooled Group|PRP Tritanrix-HepB Kft. Mix Group and PRP Tritanrix-HepB Kft. Ref Group were pooled into PRP Pooled Group.
1227435|NCT00168844|B4|Baseline|Total|Total of all reporting groups
1227436|NCT00168844|B3|Baseline|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227437|NCT00168844|B2|Baseline|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227438|NCT00168844|B1|Baseline|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227439|NCT00168844|P3|Participant Flow|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227440|NCT00168844|P2|Participant Flow|Tiotropium Respimat 10mcg (Tio R10)|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227441|NCT00168844|P1|Participant Flow|Tiotropium Respimat 5mcg (Tio R5)|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227445|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227446|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227447|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227448|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227449|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227450|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227451|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227452|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227453|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227454|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227455|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227456|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227457|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227458|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227459|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227460|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227461|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227462|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227463|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227464|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227465|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227466|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227467|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227468|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227469|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227470|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227471|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227472|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227473|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227474|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227475|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227476|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227477|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227478|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227479|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227480|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227481|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227482|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227483|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227484|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227485|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227486|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227487|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227488|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227489|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227490|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227491|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227492|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227493|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227494|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227495|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227496|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227497|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227498|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227499|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227500|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227501|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227502|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227503|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227504|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227505|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227506|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227507|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227508|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227509|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227510|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227511|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227512|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227513|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227514|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227515|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227516|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227517|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227518|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227519|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227520|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227521|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227522|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227523|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227524|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227525|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227526|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227527|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227528|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227529|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227530|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227531|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227532|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227533|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227534|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227535|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227536|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227537|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227538|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227539|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227540|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227541|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227542|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227543|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227544|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227545|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227546|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227547|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227548|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227549|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227550|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227551|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227552|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227553|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227554|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227555|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227556|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227557|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227558|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227559|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227560|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227561|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227562|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227563|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227564|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227565|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227566|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227567|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227568|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227569|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227570|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227571|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227572|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227573|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227574|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227575|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227576|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227577|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227578|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227579|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227580|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227581|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227582|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227583|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227584|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227585|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227586|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227587|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227588|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227589|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227590|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227591|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227592|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227593|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227594|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227595|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227596|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227597|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227598|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227599|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227600|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227601|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227602|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227603|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227604|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227605|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227606|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227607|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227608|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227609|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227610|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227611|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227612|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227613|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227614|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227615|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227616|NCT00168844|E3|Reported Event|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227617|NCT00168844|E2|Reported Event|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227618|NCT00168844|E1|Reported Event|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227619|NCT00168831|B4|Baseline|Total|Total of all reporting groups
1227620|NCT00168831|B3|Baseline|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227621|NCT00168831|B2|Baseline|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227622|NCT00168831|B1|Baseline|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227623|NCT00168831|P3|Participant Flow|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227624|NCT00168831|P2|Participant Flow|Tiotropium Respimat 10mcg (Tio R10)|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227625|NCT00168831|P1|Participant Flow|Tiotropium Respimat 5mcg (Tio R5)|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227626|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227627|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227628|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227629|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227630|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227631|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227632|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227633|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227634|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227635|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227636|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227637|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227638|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227639|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227640|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227641|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227642|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227643|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227644|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227645|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227646|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227647|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227648|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227649|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227650|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227651|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227652|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227653|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227654|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227655|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227656|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227657|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227658|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227659|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227660|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227661|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227662|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227663|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227664|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227665|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227666|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227667|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227668|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227669|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227670|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227671|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227672|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227673|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227674|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227675|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227676|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227677|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227678|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227679|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227680|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227681|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227682|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227683|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227684|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227685|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227686|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227687|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227688|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227689|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227690|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227691|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227692|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227693|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227694|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227695|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227696|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227697|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227698|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227699|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227700|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227701|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227702|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227703|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227704|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227705|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227706|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227707|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227708|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227709|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227710|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227711|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227712|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227713|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227714|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227715|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227716|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227717|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227718|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227719|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227720|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227721|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227722|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227723|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227724|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227725|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227726|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227727|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227728|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227729|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227730|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227731|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227732|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227733|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227734|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227735|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227736|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227737|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227738|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227739|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227740|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227741|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227742|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227743|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227744|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227745|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227746|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227747|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227748|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227749|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227750|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227751|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227752|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227753|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227754|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227755|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227756|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227757|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227758|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227759|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227760|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227761|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227762|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227763|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227764|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227765|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227766|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227767|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227768|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227769|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227770|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227771|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227772|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227773|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227774|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227775|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227776|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227777|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227778|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227779|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227780|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227781|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227782|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227783|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227784|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227785|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227786|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227787|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227788|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227789|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227790|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227791|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227792|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227793|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227794|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227795|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227796|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227797|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227798|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227799|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227800|NCT00168831|E3|Reported Event|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
1227801|NCT00168831|E2|Reported Event|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
1227802|NCT00168831|E1|Reported Event|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
1227803|NCT00168818|B4|Baseline|Total|Total of all reporting groups
1227804|NCT00168818|B3|Baseline|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
1227805|NCT00168818|B2|Baseline|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
1227806|NCT00168818|B1|Baseline|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
1227807|NCT00168818|P3|Participant Flow|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
1227808|NCT00168818|P2|Participant Flow|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
1227809|NCT00168818|P1|Participant Flow|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
1227810|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
1227811|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
1227812|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
1227813|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
1227814|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
1227815|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
1227816|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
1227817|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
1227818|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
1227819|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
1227820|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
1227821|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
1227822|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
1227823|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
1227824|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
1227825|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
1227826|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
1227827|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
1227828|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
1227829|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
1227830|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
1227831|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
1227832|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
1227833|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
1227899|NCT00168454|B3|Baseline|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
1227834|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
1227835|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
1227836|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
1227837|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
1227838|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
1227839|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
1227840|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
1227841|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
1227842|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
1227843|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
1227844|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
1227845|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
1227846|NCT00168818|E3|Reported Event|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
1227847|NCT00168818|E2|Reported Event|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
1227848|NCT00168818|E1|Reported Event|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
1227849|NCT00168805|B4|Baseline|Total|Total of all reporting groups
1227850|NCT00168805|B3|Baseline|Enoxaparin|40mg qd (once daily) subcutaneous
1227851|NCT00168805|B2|Baseline|Dabigatran 150mg|qd (once daily) oral
1227852|NCT00168805|B1|Baseline|Dabigatran 220mg|qd (once daily) oral
1227853|NCT00168805|P3|Participant Flow|Enoxaparin|40mg qd (once daily) subcutaneous
1227854|NCT00168805|P2|Participant Flow|Dabigatran 150mg|qd (once daily) oral
1227855|NCT00168805|P1|Participant Flow|Dabigatran 220mg|qd (once daily) oral
1227856|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
1227857|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
1227858|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
1227859|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
1227860|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
1227861|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
1227862|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
1227863|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
1227864|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
1227865|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
1227866|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
1227867|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
1227868|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
1227869|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
1227870|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
1227871|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
1227872|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
1227873|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
1227874|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
1227875|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
1227876|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
1227877|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
1227878|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
1227879|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
1227880|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
1227881|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
1227882|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
1227883|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
1227884|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
1227885|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
1227886|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
1227887|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
1227888|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
1227889|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
1227890|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
1227901|NCT00168454|B1|Baseline|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
1227902|NCT00168454|P6|Participant Flow|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
1227903|NCT00168454|P5|Participant Flow|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
1227904|NCT00168454|P4|Participant Flow|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
1227905|NCT00168454|P3|Participant Flow|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
1227906|NCT00168454|P2|Participant Flow|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
1227907|NCT00168454|P1|Participant Flow|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
1227908|NCT00168454|O6|Outcome|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
1227909|NCT00168454|O5|Outcome|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
1227910|NCT00168454|O4|Outcome|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
1227911|NCT00168454|O3|Outcome|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
1227912|NCT00168454|O2|Outcome|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
1227913|NCT00168454|O1|Outcome|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
1227914|NCT00168454|O6|Outcome|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
1227915|NCT00168454|O5|Outcome|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
1227916|NCT00168454|O4|Outcome|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
1227917|NCT00168454|O3|Outcome|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
1227918|NCT00168454|O2|Outcome|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
1227919|NCT00168454|O1|Outcome|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
1227920|NCT00168454|O6|Outcome|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
1227921|NCT00168454|O5|Outcome|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
1227922|NCT00168454|O4|Outcome|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
1227923|NCT00168454|O3|Outcome|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
1227924|NCT00168454|O2|Outcome|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
1227925|NCT00168454|O1|Outcome|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
1227926|NCT00168454|O6|Outcome|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
1227927|NCT00168454|O5|Outcome|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
1227928|NCT00168454|O4|Outcome|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
1227929|NCT00168454|O3|Outcome|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
1227930|NCT00168454|O2|Outcome|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
1227931|NCT00168454|O1|Outcome|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
1227932|NCT00168454|O6|Outcome|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
1227933|NCT00168454|O5|Outcome|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
1227934|NCT00168454|O4|Outcome|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
1227935|NCT00168454|O3|Outcome|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
1227936|NCT00168454|O2|Outcome|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
1227937|NCT00168454|O1|Outcome|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
1227938|NCT00168454|O6|Outcome|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
1227939|NCT00168454|O5|Outcome|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
1227940|NCT00168454|O4|Outcome|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
1227941|NCT00168454|O3|Outcome|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
1227942|NCT00168454|O2|Outcome|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
1227943|NCT00168454|O1|Outcome|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
1227944|NCT00168454|E6|Reported Event|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
1227945|NCT00168454|E5|Reported Event|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
1227946|NCT00168454|E4|Reported Event|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
1227947|NCT00168454|E3|Reported Event|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
1227948|NCT00168454|E2|Reported Event|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
1227949|NCT00168454|E1|Reported Event|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
1227950|NCT00168428|B3|Baseline|Total|Total of all reporting groups
1227951|NCT00168428|B2|Baseline|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
1227952|NCT00168428|B1|Baseline|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
1227953|NCT00168428|P2|Participant Flow|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
1228019|NCT00168389|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
1228020|NCT00168389|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1241712|NCT00116168|P1|Participant Flow|MEDI-528 0.3 mg|
1227954|NCT00168428|P1|Participant Flow|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
1227955|NCT00168428|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
1227956|NCT00168428|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
1227957|NCT00168428|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
1227958|NCT00168428|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
1227959|NCT00168428|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
1227960|NCT00168428|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
1227961|NCT00168428|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
1227962|NCT00168428|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
1227963|NCT00168428|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
1227964|NCT00168428|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
1227965|NCT00168428|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
1227966|NCT00168428|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
1227967|NCT00168428|E2|Reported Event|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
1227968|NCT00168428|E1|Reported Event|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
1227969|NCT00167310|B3|Baseline|Total|Total of all reporting groups
1227970|NCT00167310|B2|Baseline|Placebo|"Placebo (soy bean oil, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.~Placebo: 2 g of Placebo (soy bean oil) in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
1227971|NCT00167310|B1|Baseline|Omega-3 Fatty Acid|"Eicosapentaenoic acid (omega-3 fatty acid, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.~Eicosapentaenoic acid (omega-3 fatty acid): 2 g of Eicosapentaenoic acid in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
1227972|NCT00167310|P2|Participant Flow|Placebo|"Placebo (soy bean oil, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.~Placebo: 2 g of Placebo (soy bean oil) in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
1227973|NCT00167310|P1|Participant Flow|Omega-3 Fatty Acid|"Eicosapentaenoic acid (omega-3 fatty acid, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.~Eicosapentaenoic acid (omega-3 fatty acid): 2 g of Eicosapentaenoic acid in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
1227974|NCT00167310|O2|Outcome|Placebo|"Placebo (soy bean oil, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.~Placebo: 2 g of Placebo (soy bean oil) in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
1227975|NCT00167310|O1|Outcome|Omega-3 Fatty Acid|"Eicosapentaenoic acid (omega-3 fatty acid, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.~Eicosapentaenoic acid (omega-3 fatty acid): 2 g of Eicosapentaenoic acid in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
1227976|NCT00167310|O2|Outcome|Placebo|"Placebo (soy bean oil, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.~Placebo: 2 g of Placebo (soy bean oil) in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
1228105|NCT00168298|P1|Participant Flow|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
1227977|NCT00167310|O1|Outcome|Omega-3 Fatty Acid|"Eicosapentaenoic acid (omega-3 fatty acid, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.~Eicosapentaenoic acid (omega-3 fatty acid): 2 g of Eicosapentaenoic acid in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
1227978|NCT00167310|E2|Reported Event|Placebo|"Placebo (soy bean oil, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.~Placebo: 2 g of Placebo (soy bean oil) in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
1227979|NCT00167310|E1|Reported Event|Omega-3 Fatty Acid|"Eicosapentaenoic acid (omega-3 fatty acid, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.~Eicosapentaenoic acid (omega-3 fatty acid): 2 g of Eicosapentaenoic acid in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months"
1227980|NCT00167245|B3|Baseline|Total|Total of all reporting groups
1227981|NCT00167245|B2|Baseline|Group 2|placebo : placebo pills
1227982|NCT00167245|B1|Baseline|Group 1|"topiramate~Topiramate : 300mg/day for 13 weeks"
1227983|NCT00167245|P2|Participant Flow|Placebo|placebo : placebo pills
1227984|NCT00167245|P1|Participant Flow|Topiramate|"topiramate~Topiramate : 300mg/day for 13 weeks"
1227985|NCT00167245|O2|Outcome|Placebo|placebo : placebo pills
1227986|NCT00167245|O1|Outcome|Topiramate|"topiramate~Topiramate : 300mg/day for 13 weeks"
1227987|NCT00167245|O2|Outcome|Placebo|placebo : placebo pills
1227988|NCT00167245|O1|Outcome|Topirmate|"topiramate~Topiramate : 300mg/day for 13 weeks"
1227989|NCT00167245|E2|Reported Event|Placebo|placebo : placebo pills
1227990|NCT00167245|E1|Reported Event|Topiramate|"topiramate~Topiramate : 300mg/day for 13 weeks"
1227991|NCT00167206|B1|Baseline|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
1227992|NCT00167206|P1|Participant Flow|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
1227993|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
1227994|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
1227995|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
1227996|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
1227997|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
1227998|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
1227999|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
1228000|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
1228001|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
1228002|NCT00167206|E1|Reported Event|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
1228003|NCT00168389|B4|Baseline|Total|Total of all reporting groups
1228004|NCT00168389|B3|Baseline|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
1228005|NCT00168389|B2|Baseline|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228006|NCT00168389|B1|Baseline|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228007|NCT00168389|P3|Participant Flow|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
1228008|NCT00168389|P2|Participant Flow|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228009|NCT00168389|P1|Participant Flow|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228010|NCT00168389|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
1228011|NCT00168389|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228012|NCT00168389|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228013|NCT00168389|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
1228014|NCT00168389|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228015|NCT00168389|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228016|NCT00168389|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
1228017|NCT00168389|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228018|NCT00168389|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228021|NCT00168389|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228022|NCT00168389|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
1228023|NCT00168389|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228024|NCT00168389|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228025|NCT00168389|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
1228026|NCT00168389|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228027|NCT00168389|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228028|NCT00168389|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
1228029|NCT00168389|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228030|NCT00168389|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228031|NCT00168389|E3|Reported Event|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
1228032|NCT00168389|E2|Reported Event|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228033|NCT00168389|E1|Reported Event|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228034|NCT00168337|B4|Baseline|Total|Total of all reporting groups
1228035|NCT00168337|B3|Baseline|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
1228036|NCT00168337|B2|Baseline|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228037|NCT00168337|B1|Baseline|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228038|NCT00168337|P3|Participant Flow|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
1228039|NCT00168337|P2|Participant Flow|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228040|NCT00168337|P1|Participant Flow|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228041|NCT00168337|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
1228042|NCT00168337|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228043|NCT00168337|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228044|NCT00168337|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
1228045|NCT00168337|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228046|NCT00168337|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228047|NCT00168337|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
1228048|NCT00168337|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228049|NCT00168337|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228050|NCT00168337|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
1228051|NCT00168337|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228052|NCT00168337|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228053|NCT00168337|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
1228054|NCT00168337|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228106|NCT00168298|O3|Outcome|Sham Injection|Sham injection on Day 0.
1228055|NCT00168337|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228056|NCT00168337|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
1228057|NCT00168337|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228058|NCT00168337|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228059|NCT00168337|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
1228060|NCT00168337|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228061|NCT00168337|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228062|NCT00168337|E3|Reported Event|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
1228063|NCT00168337|E2|Reported Event|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228064|NCT00168337|E1|Reported Event|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
1228065|NCT00168324|B4|Baseline|Total|Total of all reporting groups
1228066|NCT00168324|B3|Baseline|Sham Injection Followed by 700 µg Dexamethasone|Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
1228067|NCT00168324|B2|Baseline|350 µg Dexamethasone Followed by 700 µg Dexamethasone|350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
1228068|NCT00168324|B1|Baseline|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
1228069|NCT00168324|P3|Participant Flow|Sham Injection Followed by 700 µg Dexamethasone|Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
1228070|NCT00168324|P2|Participant Flow|350 µg Dexamethasone Followed by 700 µg Dexamethasone|350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
1228071|NCT00168324|P1|Participant Flow|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
1228072|NCT00168324|O3|Outcome|Sham Injection|Sham injection on Day 0.
1228073|NCT00168324|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
1228074|NCT00168324|O1|Outcome|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0.
1228075|NCT00168324|O3|Outcome|Sham Injection|Sham injection on Day 0.
1228076|NCT00168324|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
1228077|NCT00168324|O1|Outcome|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0.
1228078|NCT00168324|O3|Outcome|Sham Injection|Sham injection on Day 0.
1228079|NCT00168324|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
1228080|NCT00168324|O1|Outcome|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0.
1228081|NCT00168324|O3|Outcome|Sham Injection|Sham injection on Day 0.
1228082|NCT00168324|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
1228083|NCT00168324|O1|Outcome|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0.
1228084|NCT00168324|O3|Outcome|Sham Injection|Sham injection on Day 0.
1228085|NCT00168324|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
1228086|NCT00168324|O1|Outcome|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0.
1228087|NCT00168324|E3|Reported Event|Sham Injection|Sham injection on Day 0.
1228088|NCT00168324|E2|Reported Event|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
1228089|NCT00168324|E1|Reported Event|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
1228090|NCT00168311|B3|Baseline|Total|Total of all reporting groups
1228091|NCT00168311|B2|Baseline|Sham Treatment|Sham bilateral rTMS treatment
1228092|NCT00168311|B1|Baseline|Active Treatment|Bilateral high frequency (10Hz) rTMS
1228093|NCT00168311|P2|Participant Flow|Sham Treatment|Sham bilateral rTMS treatment
1228094|NCT00168311|P1|Participant Flow|Active Treatment|Bilateral high frequency (10Hz) rTMS
1228095|NCT00168311|O2|Outcome|Sham Treatment|Sham bilateral rTMS treatment
1228096|NCT00168311|O1|Outcome|Active Treatment|Bilateral high frequency (10Hz) rTMS
1228097|NCT00168311|E2|Reported Event|Sham Treatment|Sham bilateral rTMS treatment
1228098|NCT00168311|E1|Reported Event|Active Treatment|Bilateral high frequency (10Hz) rTMS
1228099|NCT00168298|B4|Baseline|Total|Total of all reporting groups
1228100|NCT00168298|B3|Baseline|Sham Injection Followed by 700 µg Dexamethasone|Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
1228101|NCT00168298|B2|Baseline|350 µg Dexamethasone Followed by 700 µg Dexamethasone|350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
1228102|NCT00168298|B1|Baseline|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
1228103|NCT00168298|P3|Participant Flow|Sham Injection Followed by 700 µg Dexamethasone|Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
1228104|NCT00168298|P2|Participant Flow|350 µg Dexamethasone Followed by 700 µg Dexamethasone|350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
1228107|NCT00168298|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
1228291|NCT00166504|P1|Participant Flow|Vytorin|Ezetimibe 10 mg/Simvastatin 20 mg
1228108|NCT00168298|O1|Outcome|700 µg Dexamethasone|700 µg Dexamethasone intravitreal implant administered on Day 0.
1228109|NCT00168298|O3|Outcome|Sham Injection|Sham injection on Day 0.
1228110|NCT00168298|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
1228111|NCT00168298|O1|Outcome|700 µg Dexamethasone|700 µg Dexamethasone intravitreal implant administered on Day 0.
1228112|NCT00168298|O3|Outcome|Sham Injection|Sham injection on Day 0.
1228113|NCT00168298|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
1228114|NCT00168298|O1|Outcome|700 µg Dexamethasone|700 µg Dexamethasone intravitreal implant administered on Day 0.
1228115|NCT00168298|O3|Outcome|Sham Injection|Sham injection on Day 0.
1228116|NCT00168298|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
1228117|NCT00168298|O1|Outcome|700 µg Dexamethasone|700 µg Dexamethasone intravitreal implant administered on Day 0.
1228118|NCT00168298|E3|Reported Event|Sham Injection|Sham injection on Day 0.
1228119|NCT00168298|E2|Reported Event|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
1228120|NCT00168298|E1|Reported Event|700 µg Dexamethasone|700 µg Dexamethasone intravitreal implant administered on Day 0.
1228121|NCT00167102|B3|Baseline|Total|Total of all reporting groups
1228122|NCT00167102|B2|Baseline|Placebo|
1228123|NCT00167102|B1|Baseline|Alefacept|
1228124|NCT00167102|P2|Participant Flow|Placebo|
1228125|NCT00167102|P1|Participant Flow|Alefacept|
1228126|NCT00167102|O2|Outcome|Placebo|
1228127|NCT00167102|O1|Outcome|Alefacept|
1228128|NCT00167102|O2|Outcome|Placebo|Weekly intramuscular administration of placebo 15 mg for 12 weeks
1228129|NCT00167102|O1|Outcome|Alefacept|Weekly intramuscular administration of alefacept 15mg for 12 weeks
1228130|NCT00167102|E2|Reported Event|Placebo|
1228131|NCT00167102|E1|Reported Event|Alefacept|
1228132|NCT00166036|B3|Baseline|Total|Total of all reporting groups
1228133|NCT00166036|B2|Baseline|Pravastatin 80 mg|Subject treated with oral Pravastatin 80 mg for 12 Weeks.
1228134|NCT00166036|B1|Baseline|Atorvastatin 10 mg|Subject treated with oral Atorvastatin 10 mg for 12 Weeks.
1228135|NCT00166036|P2|Participant Flow|Pravastatin 80 mg|Once Daily for 12 Weeks
1228136|NCT00166036|P1|Participant Flow|Atorvastatin 10 mg|Once Daily for 12 Weeks
1228137|NCT00166036|O2|Outcome|Pravastatin 80 mg|Pravastatin 80 mg daily
1228138|NCT00166036|O1|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg daily
1228139|NCT00166036|O2|Outcome|Pravastatin 80 mg|Pravastatin 80 mg daily
1228140|NCT00166036|O1|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg taken daily
1228141|NCT00166036|E2|Reported Event|Pravastatin 80 mg|Subject treated with oral Pravastatin 80 mg for 12 Weeks.
1228142|NCT00166036|E1|Reported Event|Atorvastatin 10 mg|Subject treated with oral Atorvastatin 10 mg for 12 Weeks.
1228143|NCT00168103|B4|Baseline|Total|Total of all reporting groups
1228144|NCT00168103|B3|Baseline|Placebo|Baseline data presented here are for subjects included in the ITT population. All subjects enrolled and randomized to the Placebo arm were included in the ITT analysis population.
1228145|NCT00168103|B2|Baseline|C1-INH 20 U/kg bw|Baseline data presented here are for subjects included in the ITT population. All subjects enrolled and randomized to the C1-INH 20 U/kg bw arm were included in the ITT analysis population.
1228146|NCT00168103|B1|Baseline|C1-INH 10 U/kg bw|Baseline characteristics were calculated only for the intention to treat (ITT) and per protocol (PP) analysis populations, not for all enrolled subjects. Baseline data presented here are for subjects included in the ITT population. One (1) subject enrolled and randomized to the C1-INH 10 U/kg bw group was excluded from the ITT analysis population.
1228147|NCT00168103|P4|Participant Flow|Not Randomized|Includes one subject enrolled who was not randomized but received treatment with 20 U/kg bw C1-INH.
1228148|NCT00168103|P3|Participant Flow|Placebo|Includes all subjects enrolled and randomized to the Placebo arm.
1228149|NCT00168103|P2|Participant Flow|C1-INH 20 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 20 U/kg bw arm.
1228150|NCT00168103|P1|Participant Flow|C1-INH 10 U/kg bw|Includes all subjects enrolled and randomized to the C1 Esterase Inhibitor (C1-INH) 10 Units (U)/kg body weight (bw) arm.
1228151|NCT00168103|O3|Outcome|Placebo|Includes all subjects enrolled and randomized to the Placebo arm.
1228152|NCT00168103|O2|Outcome|C1-INH 20 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 20 U/kg bw arm.
1228153|NCT00168103|O1|Outcome|C1-INH 10 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 10 U/kg bw arm.
1228154|NCT00168103|O3|Outcome|Placebo|Includes all subjects enrolled and randomized to the Placebo arm.
1228155|NCT00168103|O2|Outcome|C1-INH 20 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 20 U/kg bw arm.
1228156|NCT00168103|O1|Outcome|C1-INH 10 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 10 U/kg bw arm.
1228157|NCT00168103|O3|Outcome|Placebo|Includes all subjects enrolled and randomized to the Placebo arm.
1228158|NCT00168103|O2|Outcome|C1-INH 20 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 20 U/kg bw arm.
1228159|NCT00168103|O1|Outcome|C1-INH 10 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 10 U/kg bw arm.
1228160|NCT00168103|O3|Outcome|Placebo|Includes all subjects enrolled and randomized to the Placebo arm.
1228161|NCT00168103|O2|Outcome|C1-INH 20 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 20 U/kg bw arm.
1228162|NCT00168103|O1|Outcome|C1-INH 10 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 10 U/kg bw arm.
1228163|NCT00168103|O3|Outcome|Placebo|Includes all subjects enrolled and randomized to the Placebo arm.
1228164|NCT00168103|O2|Outcome|C1-INH 20 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 20 U/kg bw arm.
1228165|NCT00168103|O1|Outcome|C1-INH 10 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 10 U/kg bw arm.
1228288|NCT00166504|B2|Baseline|Atorvastatin|Atorvastatin 10 mg
1228292|NCT00166504|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
1228166|NCT00168103|E3|Reported Event|Placebo|Includes subjects receiving Placebo and no rescue study medication within 4 hours after the start of the initial treatment.
1228167|NCT00168103|E2|Reported Event|C1-INH 20 U/kg bw|Includes subjects receiving 20 U/kg bw C1-INH and no rescue study medication within 4 hours after the start of the initial treatment (n=43). An additional 3 subjects not randomized to but treated with 20 U/kg bw C1-INH in this time period were also included in this group for the safety analysis.
1228168|NCT00168103|E1|Reported Event|C1-INH 10 U/kg bw|Includes subjects receiving 10 U/kg bw C1-INH and no rescue study medication within 4 hours after the start of the initial treatment.
1228169|NCT00168064|B3|Baseline|Total|Total of all reporting groups
1228170|NCT00168064|B2|Baseline|AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor|Compounded mechlorethamine-MCH (Nitrogen Mustard)in Aquaphor 0.02%
1228171|NCT00168064|B1|Baseline|PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel|Study formulation of mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel
1228172|NCT00168064|P2|Participant Flow|AP- Mechlorethamine 0.02% Compounded in Aquaphor|Compounded Mechlorethamine-MCH (Nitrogen Mustard) in Aquaphor 0.02%
1228173|NCT00168064|P1|Participant Flow|PG -Mechlorethamine (Nitrogen Mustard) 0.02% PG Gel|Study formulation of Mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel
1228174|NCT00168064|O2|Outcome|AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor|Compounded mechlorethamine-MCH (Nitrogen Mustard) in Aquaphor 0.02%
1228175|NCT00168064|O1|Outcome|PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel|Study formulation of mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel
1228176|NCT00168064|O2|Outcome|AP- Aquaphor Formulation Mechlorethamine-MCH (NM) 0.02%|Mechlorethamine-MCH (Nitrogen Mustard) compounded in Aquaphor 0.02%
1228177|NCT00168064|O1|Outcome|PG- Mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel|Study formulation of mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel
1228178|NCT00168064|E2|Reported Event|AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor|Compounded mechlorethamine-MCH (Nitrogen Mustard)in Aquaphor 0.02%
1228179|NCT00168064|E1|Reported Event|PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel|Study formulation of mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel
1228180|NCT00168038|B1|Baseline|IgPro10|All subjects treated with IgPro10
1228181|NCT00168038|P1|Participant Flow|IgPro10|All subjects treated with IgPro10
1228182|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
1228183|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
1228184|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
1228185|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
1228186|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
1228187|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
1228188|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
1228189|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
1228190|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
1228191|NCT00168038|E1|Reported Event|IgPro10|All subjects treated with IgPro10
1228192|NCT00167778|B1|Baseline|Amputee|Lower limb amputees who wore both rigid and torsion adapter pylons in random order and completed the study protocol.
1228193|NCT00167778|P1|Participant Flow|Amputee|This is a randomized cross-over study. Each participant wore both study prostheses: (1) a rigid pylon and (2) a transverse plane torsion adapter. The torsion adapter was initially set according to the manufacturer's recommendations based on body mass and activity level. After one week of acclimation, additional stiffness adjustments were made based on participant feedback. This process continued until the perceived stiffness was optimized. All participants were able to find a comfortable fit either on the first or second visit. Subjects were then randomized, provided with one of two study prostheses, and asked to wear it for 3 weeks. Data was then collected during lab visit 1, and following 1 more week, additional data was collected during lab visit 2. Subjects were then provided with the second study prosthesis and asked to wear it for 3 weeks. Data was then collected during lab visit 3, and following 1 more week, additional data was collected during lab visit 4.
1228194|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
1228195|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
1228196|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
1228197|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
1228198|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
1228199|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
1228200|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
1228201|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
1228202|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
1228203|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
1228204|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
1228205|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
1228289|NCT00166504|B1|Baseline|Vytorin|Ezetimibe 10 mg/Simvastatin 20 mg
1228206|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
1228207|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
1228208|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
1228209|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
1228210|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
1228211|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
1228212|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
1228213|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
1228214|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
1228215|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
1228216|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
1228217|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
1228218|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
1228219|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
1228220|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
1228221|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
1228222|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
1228223|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
1228224|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
1228225|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
1228226|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
1228227|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
1228228|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
1228229|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
1228230|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
1228231|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
1228232|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
1228233|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
1228234|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
1228235|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
1228236|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
1228237|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
1228238|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
1228239|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
1228240|NCT00167778|E1|Reported Event|Amputee|Lower limb amputees who wore both rigid and torsion adapter pylons in random order and completed the study protocol.
1228241|NCT00167544|B3|Baseline|Total|Total of all reporting groups
1228242|NCT00167544|B2|Baseline|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
1228243|NCT00167544|B1|Baseline|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
1228244|NCT00167544|P2|Participant Flow|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
1228245|NCT00167544|P1|Participant Flow|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
1228246|NCT00167544|O2|Outcome|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
1228247|NCT00167544|O1|Outcome|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
1228248|NCT00167544|O2|Outcome|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
1228249|NCT00167544|O1|Outcome|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
1228250|NCT00167544|O2|Outcome|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
1228251|NCT00167544|O1|Outcome|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
1228252|NCT00167544|O2|Outcome|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
1228253|NCT00167544|O1|Outcome|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
1228254|NCT00167544|O2|Outcome|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
1228255|NCT00167544|O1|Outcome|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
1228256|NCT00167544|E2|Reported Event|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
1228257|NCT00167544|E1|Reported Event|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
1228258|NCT00166712|B3|Baseline|Total|Total of all reporting groups
1228259|NCT00166712|B2|Baseline|Group 2: Alemtuzumab + Sirolimus + MMF|"Sirolimus will be taken by mouth before transplant surgery and will continue taking once daily after surgery. Group 2 will also receive 2 doses of Alemtuzumab: one during surgery and the second will be given on the second day after surgery. Mycophenolate mofetil will be give on the day of surgery and twice daily, by mouth, as instructed by the doctor.~If subjects do not experience kidney rejection after 6 months after surgery, they will be weaned off of the sirolimus and continue taking the mycophenolate mofetil."
1228260|NCT00166712|B1|Baseline|Group 1: Alemtuzumab + TAC (Prograf) + MMF|Receive two doses of alemtuzumab (Campath-1H, 30mg) by intravenous (IV) infusion. One dose during kidney transplant surgery and the second dose on day 2 (post-surgery) to achieve peripheral T-cell depletion. IV glucocorticoids will be given prior to Campath administration to limit cytokine release syndrome in association with this monoclonal antibody. MMF on the day of surgery and continue taking it by mouth, twice daily. TAC (Prograf) started on the 1st day after surgery, and then taken by mouth twice daily.
1228261|NCT00166712|P2|Participant Flow|Group 2: Alemtuzumab + Sirolimus + MMF|"Sirolimus will be taken by mouth before transplant surgery and will continue taking once daily after surgery. Group 2 will also receive 2 doses of Alemtuzumab: one during surgery and the second will be given on the second day after surgery. Mycophenolate mofetil will be give on the day of surgery and twice daily, by mouth, as instructed by the doctor.~If subjects do not experience kidney rejection after 6 months after surgery, they will be weaned off of the sirolimus and continue taking the mycophenolate mofetil."
1228262|NCT00166712|P1|Participant Flow|Group 1: Alemtuzumab + TAC (Prograf) + MMF|Receive two doses of alemtuzumab (Campath-1H, 30mg) by intravenous (IV) infusion. One dose during kidney transplant surgery and the second dose on day 2 (post-surgery) to achieve peripheral T-cell depletion. IV glucocorticoids will be given prior to Campath administration to limit cytokine release syndrome in association with this monoclonal antibody. MMF on the day of surgery and continue taking it by mouth, twice daily. TAC started on the 1st day after surgery, and then taken by mouth twice daily.
1228290|NCT00166504|P2|Participant Flow|Atorvastatin|Atorvastatin 10 mg
1228263|NCT00166712|O2|Outcome|Group 2: Alemtuzumab + Sirolimus + MMF|"Sirolimus will be taken by mouth before transplant surgery and will continue taking once daily after surgery. Group 2 will also receive 2 doses of Alemtuzumab: one during surgery and the second will be given on the second day after surgery. Mycophenolate mofetil will be give on the day of surgery and twice daily, by mouth, as instructed by the doctor.~If subjects do not experience kidney rejection after 6 months after surgery, they will be weaned off of the sirolimus and continue taking the mycophenolate mofetil."
1228264|NCT00166712|O1|Outcome|Group 1: Alemtuzumab + TAC (Prograf) + MMF|Receive two doses of alemtuzumab (Campath-1H, 30mg) by intravenous (IV) infusion. One dose during kidney transplant surgery and the second dose on day 2 (post-surgery) to achieve peripheral T-cell depletion. IV glucocorticoids will be given prior to Campath administration to limit cytokine release syndrome in association with this monoclonal antibody. MMF on the day of surgery and continue taking it by mouth, twice daily. TAC started on the 1st day after surgery, and then taken by mouth twice daily.
1228265|NCT00166712|O2|Outcome|Group 2: Alemtuzumab + Sirolimus + MMF|"Sirolimus will be taken by mouth before transplant surgery and will continue taking once daily after surgery. Group 2 will also receive 2 doses of Alemtuzumab: one during surgery and the second will be given on the second day after surgery. Mycophenolate mofetil will be give on the day of surgery and twice daily, by mouth, as instructed by the doctor.~If subjects do not experience kidney rejection after 6 months after surgery, they will be weaned off of the sirolimus and continue taking the mycophenolate mofetil."
1228266|NCT00166712|O1|Outcome|Group 1: Alemtuzumab + TAC (Prograf) + MMF|Receive two doses of alemtuzumab (Campath-1H, 30mg) by intravenous (IV) infusion. One dose during kidney transplant surgery and the second dose on day 2 (post-surgery) to achieve peripheral T-cell depletion. IV glucocorticoids will be given prior to Campath administration to limit cytokine release syndrome in association with this monoclonal antibody. MMF on the day of surgery and continue taking it by mouth, twice daily. TAC started on the 1st day after surgery, and then taken by mouth twice daily.
1228267|NCT00166712|O2|Outcome|Group 2|Evaluated for rejection of their transplanted kidney with a biopsy.
1228268|NCT00166712|O1|Outcome|Group 1|Evaluated for rejection of their transplanted kidney with a biopsy.
1228269|NCT00166712|O2|Outcome|Group 2: Alemtuzumab + Sirolimus + MMF|"Sirolimus will be taken by mouth before transplant surgery and will continue taking once daily after surgery. Group 2 will also receive 2 doses of Alemtuzumab: one during surgery and the second will be given on the second day after surgery. Mycophenolate mofetil will be give on the day of surgery and twice daily, by mouth, as instructed by the doctor.~If subjects do not experience kidney rejection after 6 months after surgery, they will be weaned off of the sirolimus and continue taking the mycophenolate mofetil."
1228270|NCT00166712|O1|Outcome|Group 1: Alemtuzumab + TAC (Prograf) + MMF|Receive two doses of alemtuzumab (Campath-1H, 30mg) by intravenous (IV) infusion. One dose during kidney transplant surgery and the second dose on day 2 (post-surgery) to achieve peripheral T-cell depletion. IV glucocorticoids will be given prior to Campath administration to limit cytokine release syndrome in association with this monoclonal antibody. MMF on the day of surgery and continue taking it by mouth, twice daily. TAC started on the 1st day after surgery, and then taken by mouth twice daily.
1228271|NCT00166712|O2|Outcome|Group 2|Evaluated for rejection of their transplanted kidney with a biopsy.
1228272|NCT00166712|O1|Outcome|Groups|Evaluated for rejection of their transplanted kidney with a biopsy.
1228273|NCT00166712|E3|Reported Event|Group 1: Post-conversion to Sirolimus|After conversion to Sirolimus, if no rejection of transplanted kidney within 9 months post-transplant, will be weaned off Sirolimus.
1228274|NCT00166712|E2|Reported Event|Group 2: Alemtuzumab + Sirolimus + MMF|"Sirolimus will be taken by mouth before transplant surgery and will continue taking once daily after surgery. Group 2 will also receive 2 doses of Alemtuzumab: one during surgery and the second will be given on the second day after surgery. Mycophenolate mofetil will be give on the day of surgery and twice daily, by mouth, as instructed by the doctor.~If subjects do not experience kidney rejection after 6 months after surgery, they will be weaned off of the sirolimus and continue taking the mycophenolate mofetil."
1228275|NCT00166712|E1|Reported Event|Group 1: Alemtuzumab + TAC + MMF|Receive two doses of alemtuzumab (Campath-1H, 30mg) by intravenous (IV) infusion. One dose during kidney transplant surgery and the second dose on day 2 (post-surgery) to achieve peripheral T-cell depletion. IV glucocorticoids will be given prior to Campath administration to limit cytokine release syndrome in association with this monoclonal antibody. MMF on the day of surgery and continue taking it by mouth, twice daily. TAC started on the 1st day after surgery, and then taken by mouth twice daily.
1228276|NCT00166517|B3|Baseline|Total|Total of all reporting groups
1228277|NCT00166517|B2|Baseline|Placebo|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
1228278|NCT00166517|B1|Baseline|RotaTeq™|Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
1228279|NCT00166517|P2|Participant Flow|Placebo|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
1228280|NCT00166517|P1|Participant Flow|RotaTeq™|Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
1228281|NCT00166517|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
1228282|NCT00166517|O1|Outcome|RotaTeq™|Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
1228283|NCT00166517|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
1228284|NCT00166517|O1|Outcome|RotaTeq™|Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
1228285|NCT00166517|E2|Reported Event|Placebo|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
1228286|NCT00166517|E1|Reported Event|RotaTeq™|Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
1228287|NCT00166504|B3|Baseline|Total|Total of all reporting groups
1228295|NCT00166504|E1|Reported Event|Vytorin|Ezetimibe 10 mg/Simvastatin 20 mg
1228296|NCT00166361|B3|Baseline|Total|Total of all reporting groups
1228297|NCT00166361|B2|Baseline|JJ Stent|Subjects assigned to this arm received a JJ stent.
1228298|NCT00166361|B1|Baseline|Memokath 051 Ureteral Stent|Subjects assigned to this arm received a Memokath 051 Ureteral Stent.
1228299|NCT00166361|P2|Participant Flow|JJ Stent|Subjects assigned to this arm received a JJ stent.
1228300|NCT00166361|P1|Participant Flow|Memokath 051 Ureteral Stent|Subjects assigned to this arm received a Memokath 051 Ureteral Stent.
1228301|NCT00166361|O2|Outcome|JJ Stent|Subjects assigned to this arm received a JJ stent.
1228302|NCT00166361|O1|Outcome|Memokath 051 Ureteral Stent|Subjects assigned to this arm received a Memokath 051 Ureteral Stent.
1228303|NCT00166361|E2|Reported Event|JJ Stent|Subjects assigned to this arm received a JJ stent.
1228304|NCT00166361|E1|Reported Event|Memokath 051 Ureteral Stent|Subjects assigned to this arm received a Memokath 051 Ureteral Stent.
1228305|NCT00166296|B3|Baseline|Total|Total of all reporting groups
1228306|NCT00166296|B2|Baseline|Placebo|Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
1228307|NCT00166296|B1|Baseline|Escitalopram|Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
1228308|NCT00166296|P2|Participant Flow|Placebo|Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
1228309|NCT00166296|P1|Participant Flow|Escitalopram|Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
1228310|NCT00166296|O2|Outcome|Placebo|Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
1228311|NCT00166296|O1|Outcome|Escitalopram|Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
1228312|NCT00166296|O2|Outcome|Placebo|Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
1228313|NCT00166296|O1|Outcome|Escitalopram|Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
1228314|NCT00166296|O2|Outcome|Placebo|Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
1228315|NCT00166296|O1|Outcome|Escitalopram|Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
1228316|NCT00166296|O2|Outcome|Placebo|Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
1228317|NCT00166296|O1|Outcome|Escitalopram|Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
1228318|NCT00166296|E2|Reported Event|Placebo|Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
1228319|NCT00166296|E1|Reported Event|Escitalopram|Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
1228320|NCT00166205|B1|Baseline|Swedish Adjustable Gastric Band (SAGB)|
1228321|NCT00166205|P1|Participant Flow|Swedish Adjustable Gastric Band (SAGB)|
1228322|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
1228323|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
1228324|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
1228325|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
1228326|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
1228327|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
1228328|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
1228329|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
1228330|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
1228331|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
1228332|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
1228333|NCT00166205|E1|Reported Event|Swedish Adjustable Gastric Band (SAGB)|
1228334|NCT00166166|B3|Baseline|Total|Total of all reporting groups
1228335|NCT00166166|B2|Baseline|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
1228336|NCT00166166|B1|Baseline|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
1228337|NCT00166166|P2|Participant Flow|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
1228338|NCT00166166|P1|Participant Flow|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
1228339|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of bradykinin, fluconazole and tetraethylammonium (TEA)
1228340|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of bradykinin and fluconazole
1228341|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of bradykinin and Tetraethylammonium (TEA)
1228342|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of bradykinin
1242853|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
1228343|NCT00166166|O2|Outcome|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of sodium nitroprusside
1228344|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of sodium nitroprusside
1228345|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of fluconazole and Tetraethylammonium (TEA)
1228346|NCT00166166|O2|Outcome|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of L-NG-monomethyl Arginine (L-NMMA) and fluconazole
1228347|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of L-NG-monomethyl Arginine (L-NMMA), and fluconazole
1228348|NCT00166166|O2|Outcome|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and fluconazole
1228349|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and fluconazole.
1228350|NCT00166166|O2|Outcome|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and L-NG-monomethyl Arginine (L-NMMA)
1228351|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and L-NG-monomethyl Arginine (L-NMMA)
1228352|NCT00166166|O2|Outcome|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and L-NG-monomethyl Arginine (L-NMMA)
1228353|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and L-NG-monomethyl Arginine (L-NMMA)
1228354|NCT00166166|O2|Outcome|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and Tetraethylammonium (TEA)
1228355|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and Tetraethylammonium (TEA).
1228356|NCT00166166|E2|Reported Event|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
1228357|NCT00166166|E1|Reported Event|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
1228358|NCT00166114|B3|Baseline|Total|Total of all reporting groups
1228359|NCT00166114|B2|Baseline|Desipramine|Subjects received 25 mg of desipramine for day 1-3, 50 mg of desipramine for day 4-7, 75 mg of desipramine for day 8-14, 100 mg of desipramine for day 15-21. Subjects titrated between 125 mg to 200 mg of desipramine for day 22-56 of intervention
1228360|NCT00166114|B1|Baseline|Escitalopram|Subjects received 10 mg of Escitalopram for 22 days and then were titrated up to 20 mg of Escitalopram after day 22 until day 56
1228361|NCT00166114|P2|Participant Flow|Desipramine|Subjects received 25 mg of desipramine for day 1-3, 50 mg of desipramine for day 4-7, 75 mg of desipramine for day 8-14, 100 mg of desipramine for day 15-21. Subjects titrated between 125 mg to 200 mg of desipramine for day 22-56 of intervention
1228362|NCT00166114|P1|Participant Flow|Escitalopram|Subjects received 10 mg of Escitalopram for 22 days and then were titrated up to 20 mg of Escitalopram after day 22 of intervention until day 56
1228363|NCT00166114|O2|Outcome|Desipramine|Subjects received 25 mg of desipramine for day 1-3, 50 mg of desipramine for day 4-7, 75 mg of desipramine for day 8-14, 100 mg of desipramine for day 15-21. Subjects titrated between 125 mg to 200 mg of desipramine for day 22-56 of intervention
1228364|NCT00166114|O1|Outcome|Escitalopram|Subjects received 10 mg of Escitalopram for 22 days and then were titrated up to 20 mg of Escitalopram after day 22 of intervention until day 56
1228365|NCT00166114|E2|Reported Event|Desipramine|25 mg of Desipramine for day 1-3, 50 mg of Desipramine for day 4-7, 75 mg of Desipramine for day 8-14, 100 mg of Desipramine for day 15-21. Titrated between 125 mg to 200 mg of Desipramine for day 22-56 of intervention
1228366|NCT00166114|E1|Reported Event|Escitalopram|10 mg of Escitalopram, and titrated up to 20 mg of Escitalopram after day 22 of intervention
1228367|NCT00165984|B1|Baseline|Single Ventricle Patients|Patients born with single ventricle heart disease
1228368|NCT00165984|P1|Participant Flow|Single Ventricle Patients|Patients born with single ventricle heart disease
1228369|NCT00165984|O3|Outcome|Heterozygotes|Transplant-free survival for patients heterozygous (G/T) at nucleotide 5665 at 7 years.
1228370|NCT00165984|O2|Outcome|Homozygous for Wild-type ppET1 5665|Transplant-free survival for patients homozygous for G at nucleotide 5665 at 7 years.
1228371|NCT00165984|O1|Outcome|Preproendothelin-1 (ppET1) 5665 Polymorphism Homozygotes|Transplant-free survival for patients homozygous for T at nucleotide 5665 at 7 years.
1228372|NCT00165984|O1|Outcome|Incidence of Preproendothelin-1 5665 Polymorphism|Incidence of Homozygosity for mutation at nucleotide 5665
1228373|NCT00165984|E1|Reported Event|Single Ventricle Patients|Patients born with single ventricle heart disease
1228374|NCT00165958|B3|Baseline|Total|Total of all reporting groups
1228375|NCT00165958|B2|Baseline|Traditional Excision|Excisional surgery of epidermal cyst : Traditional extirpation of cyst en toto
1228376|NCT00165958|B1|Baseline|Punch Excision|Punch incision of epidermal cyst : removal of cyst first with incisional effort with a punch biopsy tool
1228377|NCT00165958|P2|Participant Flow|Traditional Excision|Excisional surgery of epidermal cyst : Traditional extirpation of cyst en toto
1228378|NCT00165958|P1|Participant Flow|Punch Excision|Punch incision of epidermal cyst : removal of cyst first with incisional effort with a punch biopsy tool
1228379|NCT00165958|O2|Outcome|Traditional Excision|Excisional surgery of epidermal cyst : Traditional extirpation of cyst en toto
1228380|NCT00165958|O1|Outcome|Punch Incision|Punch incision of epidermal cyst : removal of cyst first with incisional effort with a punch biopsy tool
1242854|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
1228381|NCT00165958|E2|Reported Event|Traditional Excision|Excisional surgery of epidermal cyst : Traditional extirpation of cyst en toto
1228382|NCT00165958|E1|Reported Event|Punch Incision|Punch incision of epidermal cyst : removal of cyst first with incisional effort with a punch biopsy tool
1228383|NCT00165841|B3|Baseline|Total|Total of all reporting groups
1228384|NCT00165841|B2|Baseline|Placebo|Orally, once daily for 7 to 14-day courses intermittently during the 6-month Maintenance Treatment Phase (ITT population).
1228385|NCT00165841|B1|Baseline|Rabeprazole 20 mg|Orally, once daily for 7 to 14-day courses intermittently during the 6-month Maintenance Treatment Phase (ITT population).
1228386|NCT00165841|P2|Participant Flow|Placebo|Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.
1228387|NCT00165841|P1|Participant Flow|Rabeprazole 20 mg|Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.
1228388|NCT00165841|O2|Outcome|Placebo|Orally, once daily for 7 to 14-day courses intermittently during the 6-month Maintenance Treatment Phase (ITT population).
1228389|NCT00165841|O1|Outcome|Rabeprazole 20 mg|Orally, once daily for 7 to 14-day courses intermittently during the 6-month Maintenance Treatment Phase (ITT population).
1228390|NCT00165841|E2|Reported Event|Placebo|Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.
1228391|NCT00165841|E1|Reported Event|Rabeprazole 20 mg|Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.
1228392|NCT00165789|B5|Baseline|Total|Total of all reporting groups
1228393|NCT00165789|B4|Baseline|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
1228394|NCT00165789|B3|Baseline|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
1228395|NCT00165789|B2|Baseline|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
1228396|NCT00165789|B1|Baseline|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
1228397|NCT00165789|P4|Participant Flow|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
1228398|NCT00165789|P3|Participant Flow|Cohort 2- Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
1228399|NCT00165789|P2|Participant Flow|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
1228400|NCT00165789|P1|Participant Flow|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
1228401|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
1228402|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
1228403|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
1228404|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
1228405|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
1228406|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
1228407|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
1228408|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
1228409|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
1228410|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
1228411|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
1228412|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
1228413|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
1228414|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
1228415|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
1228416|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
1228417|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
1228418|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
1228419|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
1228420|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
1228421|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
1228422|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
1228423|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
1228424|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
1228425|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
1228426|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
1228427|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
1228428|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
1228429|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
1228430|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
1228431|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
1228432|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
1228433|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
1228434|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
1228435|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
1228436|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
1228437|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
1228438|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
1228439|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
1228440|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
1228441|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
1228442|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
1228443|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
1228444|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
1228445|NCT00165789|E4|Reported Event|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
1228446|NCT00165789|E3|Reported Event|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
1228447|NCT00165789|E2|Reported Event|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
1228448|NCT00165789|E1|Reported Event|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
1228449|NCT00165776|B5|Baseline|Total|Total of all reporting groups
1228450|NCT00165776|B4|Baseline|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
1228451|NCT00165776|B3|Baseline|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose. One subject from the 5,000 U/2 mL did not receive treatment after randomization.
1228452|NCT00165776|B2|Baseline|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
1228453|NCT00165776|B1|Baseline|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose. Two subjects from the placebo group did not receive treatment after randomization.
1228454|NCT00165776|P4|Participant Flow|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
1228455|NCT00165776|P3|Participant Flow|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
1228456|NCT00165776|P2|Participant Flow|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
1228457|NCT00165776|P1|Participant Flow|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
1228458|NCT00165776|O4|Outcome|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
1228459|NCT00165776|O3|Outcome|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
1228460|NCT00165776|O2|Outcome|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
1228461|NCT00165776|O1|Outcome|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
1228462|NCT00165776|O4|Outcome|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
1228463|NCT00165776|O3|Outcome|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
1228526|NCT00165646|B4|Baseline|Total|Total of all reporting groups
1228464|NCT00165776|O2|Outcome|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
1228465|NCT00165776|O1|Outcome|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
1243382|NCT00111657|O1|Outcome|Single Arm - Pegloticase|
1228466|NCT00165776|O4|Outcome|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
1228467|NCT00165776|O3|Outcome|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
1228468|NCT00165776|O2|Outcome|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
1228469|NCT00165776|O1|Outcome|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
1228470|NCT00165776|O4|Outcome|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
1228471|NCT00165776|O3|Outcome|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
1228472|NCT00165776|O2|Outcome|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
1228473|NCT00165776|O1|Outcome|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
1228474|NCT00165776|O4|Outcome|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
1228475|NCT00165776|O3|Outcome|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
1228476|NCT00165776|O2|Outcome|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
1228477|NCT00165776|O1|Outcome|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
1228478|NCT00165776|O4|Outcome|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
1228479|NCT00165776|O3|Outcome|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
1228480|NCT00165776|O2|Outcome|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
1228481|NCT00165776|O1|Outcome|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
1228482|NCT00165776|O4|Outcome|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
1228483|NCT00165776|O3|Outcome|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
1228484|NCT00165776|O2|Outcome|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
1228485|NCT00165776|O1|Outcome|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
1228486|NCT00165776|E4|Reported Event|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
1228487|NCT00165776|E3|Reported Event|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
1228488|NCT00165776|E2|Reported Event|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
1228489|NCT00165776|E1|Reported Event|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
1228490|NCT00165698|B3|Baseline|Total|Total of all reporting groups
1228491|NCT00165698|B2|Baseline|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
1228492|NCT00165698|B1|Baseline|Menatetrenone|15 mg t.i.d. orally for 12 months
1228493|NCT00165698|P2|Participant Flow|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
1228494|NCT00165698|P1|Participant Flow|Menatetrenone|15 mg t.i.d. orally for 12 months
1228495|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
1228496|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
1228497|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
1228498|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
1228499|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
1228500|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
1228501|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
1228502|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
1228503|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
1228504|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
1228505|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
1228506|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
1228507|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
1228508|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
1228509|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
1228510|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
1228511|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
1228512|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
1228513|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
1228514|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
1228515|NCT00165698|E2|Reported Event|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
1228516|NCT00165698|E1|Reported Event|Menatetrenone|15 mg t.i.d. orally for 12 months
1228517|NCT00165672|B3|Baseline|Total|Total of all reporting groups
1228518|NCT00165672|B2|Baseline|E3810 Pariet (Rabeprazole Sodium) 10 mg|E3810 10 mg: once daily orally for 4 weeks
1228519|NCT00165672|B1|Baseline|E3810 Pariet (Rabeprazole Sodium) 5 mg|E3810 5 mg: once daily orally for 4 weeks
1228520|NCT00165672|P2|Participant Flow|E3810 Pariet (Rabeprazole Sodium) 10 mg|E3810 10 mg: once daily orally for 4 weeks
1228521|NCT00165672|P1|Participant Flow|E3810 Pariet (Rabeprazole Sodium) 5 mg|E3810 5 mg: once daily orally for 4 weeks
1228522|NCT00165672|O2|Outcome|E3810 Pariet (Rabeprazole Sodium) 10 mg|E3810 10 mg: once daily orally for 4 weeks
1228523|NCT00165672|O1|Outcome|E3810 Pariet (Rabeprazole Sodium) 5 mg|E3810 5 mg: once daily orally for 4 weeks
1228524|NCT00165672|E2|Reported Event|E3810 Pariet (Rabeprazole Sodium) 10 mg|E3810 10 mg: once daily orally for 4 weeks
1228525|NCT00165672|E1|Reported Event|E3810 Pariet (Rabeprazole Sodium) 5 mg|E3810 5 mg: once daily orally for 4 weeks
1228527|NCT00165646|B3|Baseline|E3810 10 mg|E3810 (Pariet (Rabeprazole Sodium))10 mg once daily orally for 4 weeks
1228528|NCT00165646|B2|Baseline|E3810 5 mg|E3810 (Pariet (Rabeprazole Sodium)) 5 mg once daily orally for 4 weeks
1228530|NCT00165646|P3|Participant Flow|E3810 10 mg|E3810 (Pariet (Rabeprazole Sodium))10 mg once daily orally for 4 weeks
1228531|NCT00165646|P2|Participant Flow|E3810 5 mg|E3810 (Pariet (Rabeprazole Sodium)) 5 mg once daily orally for 4 weeks
1228532|NCT00165646|P1|Participant Flow|Placebo|once daily orally for 4 weeks
1228533|NCT00165646|O3|Outcome|E3810 10 mg|E3810 (Pariet (Rabeprazole Sodium))10 mg once daily orally for 4 weeks
1228534|NCT00165646|O2|Outcome|E3810 5 mg|E3810 (Pariet (Rabeprazole Sodium)) 5 mg once daily orally for 4 weeks
1228535|NCT00165646|O1|Outcome|Placebo|once daily orally for 4 weeks
1228536|NCT00165646|E3|Reported Event|E3810 10 mg|E3810 (Pariet (Rabeprazole Sodium))10 mg once daily orally for 4 weeks
1228537|NCT00165646|E2|Reported Event|E3810 5 mg|E3810 (Pariet (Rabeprazole Sodium)) 5 mg once daily orally for 4 weeks
1228538|NCT00165646|E1|Reported Event|Placebo|once daily orally for 4 weeks
1228539|NCT00165503|B1|Baseline|Cisplatin, Sodium Thiosulfate, Alimta|Heated Cisplatin will be given as a one-hour lavage of the chest and abdominal cavity following surgery.Cisplatin will also be administered intravenously as part of chemotherapy 6-10 weeks after surgery. It will be given on day 1 of each 21-day treatment cycle for 3 cycles. Sodium Thiosulfate Given intravenously over 6 hours following heated cisplatin lavage. Alimta Given intravenously on day 1 of each 21-day treatment cycle for a total of 3 cycles beginning 6-10 weeks after surgery.
1228540|NCT00165503|P1|Participant Flow|Cisplatin, Sodium Thiosulfate, Alimta|Heated Cisplatin will be given as a one-hour lavage of the chest and abdominal cavity following surgery.Cisplatin will also be administered intravenously as part of chemotherapy 6-10 weeks after surgery. It will be given on day 1 of each 21-day treatment cycle for 3 cycles. Sodium Thiosulfate Given intravenously over 6 hours following heated cisplatin lavage. Alimta Given intravenously on day 1 of each 21-day treatment cycle for a total of 3 cycles beginning 6-10 weeks after surgery.
1228541|NCT00165503|O1|Outcome|Surgery+Heated Cisplatin+Sodium Thiosulfate+Adjuvant CT|Participants undergo surgery, Pleurectomy/Decortication, followed by heated cisplatin given as a one-hour lavage of the chest and abdominal cavity then sodium thiosulfate given intravenously over 6 hours. The adjuvant chemotherapy regimen beginning 6-10 weeks after surgery is a combination of cisplatin and Alimta each given day 1 of a 21-day cycle for 3 cycles.
1228542|NCT00165503|E1|Reported Event|Surgery + Heated Cisplatin Lavage + Sodium Thiosulfate|Participants undergo surgery, Pleurectomy/Decortication, followed by heated cisplatin given as a one-hour lavage of the chest and abdominal cavity then sodium thiosulfate given intravenously over 6 hours.
1228543|NCT00163657|B4|Baseline|Total|Total of all reporting groups
1228544|NCT00163657|B3|Baseline|Treatment Arm 3|Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
1228545|NCT00163657|B2|Baseline|Treatment Arm 2|Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)
1228546|NCT00163657|B1|Baseline|Treatment Arm 1|Immunosuppression TAC (tacrolimus) and CS (cyclosporine)
1228547|NCT00163657|P3|Participant Flow|Treatment Arm 3|Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
1228548|NCT00163657|P2|Participant Flow|Treatment Arm 2|Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)
1228549|NCT00163657|P1|Participant Flow|Treatment Arm 1|Immunosuppression TAC (tacrolimus) and CS (cyclosporine)
1228550|NCT00163657|O3|Outcome|Treatment Arm 3|Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
1228551|NCT00163657|O2|Outcome|Treatment Arm 2|Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)
1228552|NCT00163657|O1|Outcome|Treatment Arm 1|Immunosuppression TAC (tacrolimus) and CS (cyclosporine)
1228553|NCT00163657|O3|Outcome|Treatment Arm 3|Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
1228554|NCT00163657|O2|Outcome|Treatment Arm 2|Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)
1228555|NCT00163657|O1|Outcome|Treatment Arm 1|Immunosuppression TAC (tacrolimus) and CS (cyclosporine)
1228556|NCT00163657|E3|Reported Event|Treatment Arm 3|Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
1228557|NCT00163657|E2|Reported Event|Treatment Arm 2|Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)
1228558|NCT00163657|E1|Reported Event|Treatment Arm 1|Immunosuppression TAC (tacrolimus) and CS (cyclosporine)
1228559|NCT00163293|B4|Baseline|Total|Total of all reporting groups
1228560|NCT00163293|B3|Baseline|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228561|NCT00163293|B2|Baseline|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228562|NCT00163293|B1|Baseline|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228563|NCT00163293|P3|Participant Flow|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228564|NCT00163293|P2|Participant Flow|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228565|NCT00163293|P1|Participant Flow|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228566|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228567|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228568|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228569|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228570|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1230261|NCT00156533|O2|Outcome|QHS Zolpidem|QHS (i.e., nightly) dosing with 10mg of zolpidem
1228571|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228572|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228573|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228574|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228575|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228576|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228577|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228578|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228579|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228580|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228581|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228582|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228583|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228584|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228585|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228586|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228587|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228588|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228589|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228590|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228591|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228592|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228593|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228594|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228595|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228596|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228597|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228598|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228599|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228600|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228601|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228602|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228603|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228604|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228605|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228606|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228607|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228608|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228609|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228610|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228611|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228612|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228613|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228614|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228615|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228616|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228617|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228618|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228619|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228620|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228621|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228622|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228623|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228624|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228625|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228626|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228627|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228628|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228629|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228630|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228631|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228632|NCT00163293|O3|Outcome|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228633|NCT00163293|O2|Outcome|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228634|NCT00163293|O1|Outcome|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228635|NCT00163293|E3|Reported Event|Placebo|Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228636|NCT00163293|E2|Reported Event|Ciclesonide 200 µg|Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228637|NCT00163293|E1|Reported Event|Ciclesonide 100 µg|Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
1228638|NCT00163215|B1|Baseline|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
1228639|NCT00163215|P1|Participant Flow|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
1228640|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
1228641|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
1228642|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
1228643|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
1228644|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
1228645|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
1228646|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
1228647|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
1228648|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
1228649|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
1228650|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
1228651|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
1228652|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
1228653|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
1228654|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
1243713|NCT00110305|B3|Baseline|TMC 150 mg|TMC278 150 mg once daily
1228655|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
1228656|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
1228657|NCT00163215|E1|Reported Event|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
1228658|NCT00163189|B1|Baseline|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
1228659|NCT00163189|P1|Participant Flow|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
1228660|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
1228661|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
1228662|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
1228663|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
1228664|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
1228665|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
1228666|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
1228667|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
1228668|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
1228669|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
1228670|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
1228671|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
1228672|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
1228673|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
1228674|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
1228675|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
1228676|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
1228677|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
1228678|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
1228679|NCT00163189|E1|Reported Event|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
1228680|NCT00163020|B3|Baseline|Total|Total of all reporting groups
1228681|NCT00163020|B2|Baseline|2 - Control (Castor Oil)|Control Group will receive a weekly dose of placebo (castor oil) via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first.
1228682|NCT00163020|B1|Baseline|1 Test Group (170HP)|Test Group will receive a weekly dose of 170HP via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first.
1228683|NCT00163020|P2|Participant Flow|2 - Control (Castor Oil)|Control Group will receive a weekly dose of placebo (castor oil) via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first.
1228684|NCT00163020|P1|Participant Flow|1 Test Group (170HP)|Test Group will receive a weekly dose of 170HP via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first.
1228685|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
1241034|NCT00117949|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
1228686|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
1230708|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
1228687|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
1228688|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
1228689|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
1228690|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
1228691|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
1228692|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
1228693|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
1228694|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
1228695|NCT00163020|O2|Outcome|Triplet Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Triplet Pregnancies
1228696|NCT00163020|O1|Outcome|Triplet Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Triplet Pregnancies
1228697|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
1228698|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
1228699|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
1228700|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
1228701|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
1228702|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
1228703|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
1228704|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
1228705|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
1228706|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
1228707|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
1228708|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
1228709|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
1228710|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
1228711|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
1228712|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
1228713|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
1228714|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
1228715|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
1228716|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
1228717|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
1228718|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
1228719|NCT00163020|E2|Reported Event|Control (Castor Oil)|Both Twins and Triplets in the Control Group received a weekly dose of placebo (castor oil) via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever came first.
1228720|NCT00163020|E1|Reported Event|Test Group (170HP)|Both Twins and Triplets in the Test Group received a weekly dose of 170HP via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever came first.
1228721|NCT00162981|B3|Baseline|Total|Total of all reporting groups
1228722|NCT00162981|B2|Baseline|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
1228723|NCT00162981|B1|Baseline|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
1228724|NCT00162981|P2|Participant Flow|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
1228725|NCT00162981|P1|Participant Flow|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
1228726|NCT00162981|O2|Outcome|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
1228727|NCT00162981|O1|Outcome|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
1228728|NCT00162981|O2|Outcome|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
1228729|NCT00162981|O1|Outcome|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
1228730|NCT00162981|O2|Outcome|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
1228731|NCT00162981|O1|Outcome|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
1228732|NCT00162981|O2|Outcome|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
1228733|NCT00162981|O1|Outcome|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
1228734|NCT00162981|O2|Outcome|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
1228735|NCT00162981|O1|Outcome|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
1230262|NCT00156533|O1|Outcome|Placebo|QHS (i.e., nightly) dosing with placebo
1228736|NCT00162981|E2|Reported Event|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
1228737|NCT00162981|E1|Reported Event|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
1228738|NCT00162942|B3|Baseline|Total|Total of all reporting groups
1228739|NCT00162942|B2|Baseline|Sham|Sham, ten apheresis sessions within 9 weeks
1228740|NCT00162942|B1|Baseline|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
1228741|NCT00162942|P2|Participant Flow|Sham|Sham, ten apheresis sessions within 9 weeks
1228742|NCT00162942|P1|Participant Flow|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
1228743|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
1228744|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
1228745|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
1228746|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
1228747|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
1228748|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
1228749|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
1228750|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
1228751|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
1228752|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
1228753|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
1228754|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
1228755|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
1228756|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
1228757|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
1228758|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
1228759|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
1228760|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
1228761|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
1228762|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
1228763|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
1228764|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
1228765|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
1228766|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
1228767|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
1228768|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
1228769|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
1228770|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
1228771|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
1228772|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
1228773|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
1228774|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
1228775|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
1228776|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
1228777|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
1228778|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
1228779|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
1228780|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
1228781|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
1228782|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
1228783|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
1228784|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
1228785|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
1228786|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
1228787|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
1228788|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
1228789|NCT00162370|B1|Baseline|Definity|"Open-lable, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri-, post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events.~Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection"
1228790|NCT00162370|P1|Participant Flow|Definity|"Open-lable, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri-, post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events.~Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection"
1228791|NCT00162370|O1|Outcome|Definity|"All patients will undergo a gray scale baseline unenhanced imaging session (apical 2- or 4 chamber view), as well as a DEFINITY (Perflutren Lipid Microsphere Injectable Suspension)-enhanced rest and a DEFINITY enhanced exercise or dobutamine stress echocardiography imaging session. The unenhanced and DEFINITY-enhanced rest and stress echocardiography imaging sessions will be performed on the same day. For the DEFINITY-enhanced imaging sessions all patients will receive diluted DEFINITY intravenously (IV). Diluted DEFINITY will be prepared by mixing 1 mL of activated DEFINITY® with 9 mL of normal saline in a 10 mL syringe.~Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection"
1228830|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
1230709|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
1228792|NCT00162370|O1|Outcome|Definity|"Open-lable, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri-, post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events.~Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection"
1228793|NCT00162370|E1|Reported Event|Definity|"Open-lable, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri-, post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events.~Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection"
1228794|NCT00162266|B4|Baseline|Total|Total of all reporting groups
1228795|NCT00162266|B3|Baseline|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228796|NCT00162266|B2|Baseline|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228797|NCT00162266|B1|Baseline|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228798|NCT00162266|P4|Participant Flow|Open-Label (OL) Abatacept (10 mg / kg)|Following a 5-month interim (where the placebo group was split into 2mg/kg abatacept or placebo and participants in 2 original abatacept continued at same dose), participants who enrolled in OL period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g.
1228799|NCT00162266|P3|Participant Flow|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228800|NCT00162266|P2|Participant Flow|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228801|NCT00162266|P1|Participant Flow|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228802|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228803|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228804|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228805|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228806|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228807|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228808|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228809|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DBperiod received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately weight-tiered dose of abatacept 10 mg/kg.
1228810|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228811|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228812|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228813|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228814|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228815|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228816|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228817|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228818|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228819|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228820|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228821|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228822|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg /kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228823|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the double-blind period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228824|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
1228825|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by an IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228826|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228827|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228828|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228829|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
1228998|NCT00162136|B4|Baseline|35 mg/m2|Ixabepilone
1228999|NCT00162136|B3|Baseline|30 mg/m2|Ixabepilone
1229000|NCT00162136|B2|Baseline|20 mg/m2|Ixabepilone
1228831|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
1228832|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
1228833|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
1228834|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
1228835|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228836|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228837|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228838|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228839|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228840|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228841|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228842|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228843|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228844|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228845|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228846|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228847|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228848|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228849|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228850|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1229001|NCT00162136|B1|Baseline|10 mg/m2|Ixabepilone
1241035|NCT00117949|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
1228851|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228852|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228853|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the double-blind period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228854|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228855|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228856|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228857|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228858|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228859|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228860|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228861|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228862|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228863|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228864|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228865|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228866|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228867|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228868|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228869|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228870|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1229002|NCT00162136|P1|Participant Flow|Ixabepilone|Intravenous (IV) Infusion; 10, 20, 30, 35, 40 & 45 mg/m2, once every 21 days (1 cycle), up to 9 cycles
1229003|NCT00162136|O1|Outcome|All Treated Participants|
1228871|NCT00162266|O1|Outcome|OL Abatacept (10 mg / kg)|OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by I) infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g.
1228872|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228873|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg /kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228874|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228875|NCT00162266|O1|Outcome|OL Abatacept (10 mg / kg)|OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g.
1228876|NCT00162266|O1|Outcome|OL Abatacept (10 mg / kg)|OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g.
1228877|NCT00162266|O1|Outcome|OL Abatacept (10 mg / kg)|OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g.
1228878|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228879|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg Group|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228880|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg Group|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by intravenous IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228881|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228882|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228883|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228884|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228885|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228886|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228887|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an on OL weight-tiered dose of abatacept 10 mg/kg.
1228888|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228889|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228890|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1229004|NCT00162136|O1|Outcome|Treated Subjects|All treated subjects with measurement at timepoint
1229005|NCT00162136|O5|Outcome|Grade 4|Life-threatening or disabling
1228891|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228892|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228893|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
1228894|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg Group|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228895|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg Group|Participants in the DBperiod received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228896|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
1228897|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg Group|Participants in the double-blind period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
1228898|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg Group|Participants in the double-blind period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
1228899|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228900|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228901|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228902|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228903|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228904|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228905|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228906|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228907|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228908|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228909|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228910|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228911|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228912|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228913|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228914|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228915|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228916|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228917|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228918|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228919|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228920|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1229006|NCT00162136|O4|Outcome|Grade 3|Severe
1229007|NCT00162136|O3|Outcome|Grade 2|Moderate
1229008|NCT00162136|O2|Outcome|Grade 1|Mild
1229009|NCT00162136|O1|Outcome|Grade 0|Absent
1228921|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228922|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228923|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228924|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228925|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
1228926|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228927|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
1228928|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228929|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228930|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228931|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228932|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228933|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228934|NCT00162266|O4|Outcome|Open-Label (OL) Abatacept (10 mg / kg)|Following a 5-month interim (where the placebo group was split into 2mg/kg abatacept or placebo and participants in 2 original abatacept continued at same dose), participants who enrolled in OL period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g.
1228935|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1229010|NCT00162136|O3|Outcome|All Grades|Grades 1-4
1229011|NCT00162136|O2|Outcome|Grade 3/4|Grade 3=Severe, Grade 4=Life-threatening or disabling
1229012|NCT00162136|O1|Outcome|Grade 1/2|Grade 1=Mild, Grade 2=Moderate
1228936|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228937|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228938|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228939|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228940|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228941|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
1228942|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
1228943|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
1228944|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
1228945|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
1228946|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
1228947|NCT00162266|O1|Outcome|OL Abatacept (10 mg / kg)|OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g.
1228948|NCT00162266|O1|Outcome|OL Abatacept (10 mg / kg)|OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g.
1228949|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
1228950|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
1228951|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
1229013|NCT00162136|O6|Outcome|45 mg/m2|Ixabepilone
1229014|NCT00162136|O5|Outcome|40 mg/m2|Ixabepilone
1229015|NCT00162136|O4|Outcome|35 mg/m2|Ixabepilone
1229016|NCT00162136|O3|Outcome|30 mg/m2|Ixabepilone
1229017|NCT00162136|O2|Outcome|20 mg/m2|Ixabepilone
1229018|NCT00162136|O1|Outcome|10 mg/m2|Ixabepilone
1228952|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228953|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228954|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228955|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228956|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228957|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228958|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228959|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228960|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228961|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228962|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228963|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228964|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1229019|NCT00162136|E6|Reported Event|Ixa 45 mg/m2|
1229020|NCT00162136|E5|Reported Event|Ixa 40 mg/m2|
1229021|NCT00162136|E4|Reported Event|Ixa 35 mg/m2|
1229022|NCT00162136|E3|Reported Event|Ixa 30 mg/m2|
1229023|NCT00162136|E2|Reported Event|Ixa 20 mg/m2|
1229024|NCT00162136|E1|Reported Event|Ixa 10 mg/m2|
1228965|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228966|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228967|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228968|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228969|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228970|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228971|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228972|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228973|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228974|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228975|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228976|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228977|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1229025|NCT00162123|B9|Baseline|Total|Total of all reporting groups
1229026|NCT00162123|B8|Baseline|Follow-up|Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
1229926|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
1228978|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228979|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228980|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228981|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228982|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228983|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228984|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228985|NCT00162266|O3|Outcome|DB Placebo + Methotrexate|Participants in the DB study received a placebo administered monthly IV plus methotrexate. Participants were maintained on a stable dose of methotrexate (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate(maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228986|NCT00162266|O2|Outcome|DB Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept administered monthly IV plus methotrexate. Participants were maintained on a stable dose of methotrexate(10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228987|NCT00162266|O1|Outcome|DB Abatacept 10 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept administered monthly IV plus methotrexateParticipants were maintained on a stable dose of methotrexate (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228988|NCT00162266|O3|Outcome|DB Placebo + Methotrexate|Participants in the DB study received a placebo that was administered IV monthly plus methotrexate. Participants were maintained on a stable dose of methotrexate (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate(maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold, or azathioprine) during Days 181 to 360 of the DB period.
1228989|NCT00162266|O2|Outcome|DB Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept administered IV monthly plus methotrexate. Participants were maintained on a stable dose of methotrexate (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold, or azathioprine) during Days 181 to 360 of the DB period.
1228990|NCT00162266|O1|Outcome|DB Abatacept 10 mg/kg + Methotrexate|Participants received a weight-tiered dose of 10 mg/kg of abatacept, administered intravenously(IV) monthly plus methotrexate. Participants were maintained on a stable dose of methotrexate(10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
1228991|NCT00162266|E4|Reported Event|Placebo+MTX|
1228992|NCT00162266|E3|Reported Event|Abatacept (LT)|
1228993|NCT00162266|E2|Reported Event|Aba 2mg/kg+MTX|
1228994|NCT00162266|E1|Reported Event|Aba 10mg/kg+MTX|
1228995|NCT00162136|B7|Baseline|Total|Total of all reporting groups
1228996|NCT00162136|B6|Baseline|45 mg/m2|Ixabepilone
1228997|NCT00162136|B5|Baseline|40 mg/m2|Ixabepilone
1229027|NCT00162123|B7|Baseline|Extended Maintenance: Ipilimumab, 0.3 mg/kg|Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
1229028|NCT00162123|B6|Baseline|Extended Maintenance: Ipilimumab, 3 mg/kg|Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
1229029|NCT00162123|B5|Baseline|Extended Maintenance: Ipilimumab, 10 mg/kg|Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
1229030|NCT00162123|B4|Baseline|First Reinduction: Ipilimumab, Other Dosage|Participants who received a dose other than 10, 3, or 0.3 mg/kg ipilimumab in parent study received a first reinduction of either 3 or 10 mg/kg in current study.
1229031|NCT00162123|B3|Baseline|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
1229032|NCT00162123|B2|Baseline|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
1229033|NCT00162123|B1|Baseline|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
1229034|NCT00162123|P8|Participant Flow|Follow-up|Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
1229035|NCT00162123|P7|Participant Flow|Extended Maintenance Only: Ipilimumab, 0.3 mg/kg|Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
1229036|NCT00162123|P6|Participant Flow|Extended Maintenance Only: Ipilimumab, 3 mg/kg|Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
1229037|NCT00162123|P5|Participant Flow|Extended Maintenance Only: Ipilimumab, 10 mg/kg|Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
1229038|NCT00162123|P4|Participant Flow|First Reinduction: Ipilimumab, Other Dosage|Participants who received a dose other than 10, 3, or 0.3 mg/kg ipilimumab in parent study received a first reinduction of either 3 or 10 mg/kg in current study.
1229039|NCT00162123|P3|Participant Flow|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
1229040|NCT00162123|P2|Participant Flow|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
1229041|NCT00162123|P1|Participant Flow|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
1229042|NCT00162123|O3|Outcome|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
1229043|NCT00162123|O2|Outcome|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
1229044|NCT00162123|O1|Outcome|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
1229045|NCT00162123|O3|Outcome|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
1229046|NCT00162123|O2|Outcome|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 3 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
1229047|NCT00162123|O1|Outcome|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
1229048|NCT00162123|O7|Outcome|Follow-up|Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
1229049|NCT00162123|O6|Outcome|Extended Maintenance: Ipilimumab, 0.3 mg/kg|Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
1229050|NCT00162123|O5|Outcome|Extended Maintenance: Ipilimumab, 3 mg/kg|Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
1229051|NCT00162123|O4|Outcome|Extended Maintenance: Ipilimumab, 10 mg/kg|Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
1229052|NCT00162123|O3|Outcome|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 0.3 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
1229053|NCT00162123|O2|Outcome|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
1229054|NCT00162123|O1|Outcome|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
1229055|NCT00162123|O3|Outcome|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
1229056|NCT00162123|O2|Outcome|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
1229057|NCT00162123|O1|Outcome|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
1229058|NCT00162123|O3|Outcome|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
1230263|NCT00156533|O4|Outcome|CTRL|Monitor only condition (no placebo and no zolpidem).
1229059|NCT00162123|O2|Outcome|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
1229060|NCT00162123|O1|Outcome|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
1229061|NCT00162123|E8|Reported Event|Follow-up|Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
1229062|NCT00162123|E7|Reported Event|Extended Maintenance Only: Ipilimumab, 0.3 mg/kg|Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
1229063|NCT00162123|E6|Reported Event|Extended Maintenance Only: Ipilimumab, 3 mg/kg|Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
1229064|NCT00162123|E5|Reported Event|Extended Maintenance Only: Ipilimumab, 10 mg/kg|Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
1229065|NCT00162123|E4|Reported Event|First Reinduction: Ipilimumab, Other Dosage|Participants who received a dose other than 10, 3, or 0.3 mg/kg ipilimumab in parent study received a first reinduction of either 3 or 10 mg/kg in current study.
1229066|NCT00162123|E3|Reported Event|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
1229067|NCT00162123|E2|Reported Event|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
1229068|NCT00162123|E1|Reported Event|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
1229069|NCT00162097|B5|Baseline|Total|Total of all reporting groups
1229070|NCT00162097|B4|Baseline|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
1229071|NCT00162097|B3|Baseline|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
1229072|NCT00162097|B2|Baseline|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
1229073|NCT00162097|B1|Baseline|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
1229074|NCT00162097|P4|Participant Flow|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
1241036|NCT00117949|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
1229075|NCT00162097|P3|Participant Flow|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
1229076|NCT00162097|P2|Participant Flow|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
1229077|NCT00162097|P1|Participant Flow|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
1229078|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
1229079|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
1229080|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
1229081|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
1229082|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
1229083|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
1229084|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
1229085|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
1229086|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
1229155|NCT00161616|O1|Outcome|rhBMP-2/ACS|InductOs (dibotermin alfa) contains 12 mg of recombinant human bone morphogenetic protein-2 (rhBMP-2) in the form of a 1.5 mg/ml solution on an absorbable collagen sponge (ACS) implanted once at the time of definitive fracture coverage + surgical fixation
1229156|NCT00161616|E2|Reported Event|Standard of Care|Standard of Care: Surgical fixation only
1229087|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
1229088|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
1229089|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
1229090|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
1229091|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
1229092|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
1229093|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
1229094|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
1229095|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
1229096|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
1229097|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
1229098|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
1229157|NCT00161616|E1|Reported Event|rhBMP-2/ACS|InductOs (dibotermin alfa) contains 12 mg of recombinant human bone morphogenetic protein-2 (rhBMP-2) in the form of a 1.5 mg/ml solution on an absorbable collagen sponge (ACS) implanted once at the time of definitive fracture coverage + surgical fixation
1229158|NCT00161473|B3|Baseline|Total|Total of all reporting groups
1229099|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
1229100|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
1229101|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
1229102|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
1229103|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
1229104|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
1229105|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
1229106|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
1229107|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
1229108|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
1229109|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
1229110|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
1229159|NCT00161473|B2|Baseline|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
1229160|NCT00161473|B1|Baseline|Prazosin|Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
1229111|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
1229112|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
1229113|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
1229114|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
1229115|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
1229116|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
1229117|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
1229118|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
1229119|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
1229120|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
1229121|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
1229122|NCT00162097|O5|Outcome|Participants Not Dosed|Participants were enrolled in the study and discontinued prior to study drug administration
1229123|NCT00162097|O4|Outcome|Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
1229161|NCT00161473|P2|Participant Flow|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
1230001|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
1229124|NCT00162097|O3|Outcome|Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
1229125|NCT00162097|O2|Outcome|Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
1229126|NCT00162097|O1|Outcome|Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
1229127|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
1229128|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
1229129|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
1229130|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
1229131|NCT00162097|E5|Reported Event|Not Dosed|
1229132|NCT00162097|E4|Reported Event|EFV600mg Participants With Normal Hepatic Function|
1229133|NCT00162097|E3|Reported Event|EFV600mg Participants With Severe Hepatic Impairment|
1229134|NCT00162097|E2|Reported Event|EFV600mg Participants With Moderate Hepatic Impairment|
1229135|NCT00162097|E1|Reported Event|EFV600mg Participants With Mild Hepatic Impairment|
1229136|NCT00162032|B3|Baseline|Total|Total of all reporting groups
1229137|NCT00162032|B2|Baseline|Adolescents (Ages 12-16)|Arm B children 12-16 years of age
1229138|NCT00162032|B1|Baseline|Children (Ages 4-11)|Arm A children 4-11 years of age
1229139|NCT00162032|P2|Participant Flow|Adolescents (Ages 12-16)|Arm B children 12-16 years of age
1229140|NCT00162032|P1|Participant Flow|Children (Ages 4-11)|Arm A children 4-11 years of age
1229141|NCT00162032|O4|Outcome|Adolescents (12-16 Years) Abnormal|sss (summed stress score >4, high risk
1229142|NCT00162032|O3|Outcome|Children (4-11 Years) Abnormal|SSS (summed stress score)>4, high risk
1229143|NCT00162032|O2|Outcome|Adolescents (12-16 Years) Normal|SSS (summed stress score) <4, low risk
1229144|NCT00162032|O1|Outcome|Children (4 -11 Years) Normal|SSS (summed stress score) <=4, low risk
1229145|NCT00162032|E2|Reported Event|Adolescents (Ages 12-16)|Arm B adolescents 12-16 years of age
1229146|NCT00162032|E1|Reported Event|Children (Ages 4-11)|Arm A children 4-11 years of age
1229147|NCT00161616|B3|Baseline|Total|Total of all reporting groups
1229148|NCT00161616|B2|Baseline|Standard of Care|Standard of Care: Surgical fixation only
1229149|NCT00161616|B1|Baseline|rhBMP-2/ACS|InductOs (dibotermin alfa) contains 12 mg of recombinant human bone morphogenetic protein-2 (rhBMP-2) in the form of a 1.5 mg/ml solution on an absorbable collagen sponge (ACS) implanted once at the time of definitive fracture coverage + surgical fixation
1229150|NCT00161616|P2|Participant Flow|Standard of Care|Standard of Care: Surgical fixation only
1229151|NCT00161616|P1|Participant Flow|rhBMP-2/ACS|InductOs (dibotermin alfa) contains 12 mg of recombinant human bone morphogenetic protein-2 (rhBMP-2) in the form of a 1.5 mg/ml solution on an absorbable collagen sponge (ACS) implanted once at the time of definitive fracture coverage + surgical fixation
1229152|NCT00161616|O2|Outcome|Standard of Care|Standard of Care: Surgical fixation only
1229153|NCT00161616|O1|Outcome|rhBMP-2/ACS|InductOs (dibotermin alfa) contains 12 mg of recombinant human bone morphogenetic protein-2 (rhBMP-2) in the form of a 1.5 mg/ml solution on an absorbable collagen sponge (ACS) implanted once at the time of definitive fracture coverage + surgical fixation
1229154|NCT00161616|O2|Outcome|Standard of Care|Standard of Care: Surgical fixation only
1229217|NCT00160693|E1|Reported Event|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
1241037|NCT00117949|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
1229162|NCT00161473|P1|Participant Flow|Prazosin|Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
1229163|NCT00161473|O2|Outcome|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
1229164|NCT00161473|O1|Outcome|Prazosin|Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
1229165|NCT00161473|O2|Outcome|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
1229166|NCT00161473|O1|Outcome|Prazosin|Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
1229167|NCT00161473|O2|Outcome|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
1229168|NCT00161473|O1|Outcome|Prazosin|Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
1229169|NCT00161473|O2|Outcome|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
1229170|NCT00161473|O1|Outcome|Prazosin|Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
1229171|NCT00161473|E2|Reported Event|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
1229172|NCT00161473|E1|Reported Event|Prazosin|Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
1229173|NCT00161382|B3|Baseline|Total|Total of all reporting groups
1229174|NCT00161382|B2|Baseline|Control Group|No intervention: Control curriculum consists of standard sexual education.
1229175|NCT00161382|B1|Baseline|Intervention Group|"Participants receiving HIV, STD, and pregnancy prevention curriculum~HIV, STD, Pregnancy Prevention Curriculum: This HIV, STD, and pregnancy intervention program entitled, It's Your Game...Keep it Real, consists of 12 lessons delivered in Grades 7 and 8. In each grade, the program integrates group-based classroom activities (e.g., role plays, group discussion, small group activities) with personalized journaling and individual tailored activities delivered on laptop computers. A life skills decision-making paradigm (Select, Detect, Protect) underlies the activities, teaching students to select personal limits regarding risk behaviors, to detect signs or situations that might challenge these limits, and to use refusal skills and other tactics to protect these limits."
1229176|NCT00161382|P2|Participant Flow|Control Group|No intervention: Control curriculum consists of standard sexual education.
1229177|NCT00161382|P1|Participant Flow|Intervention Group|"Participants receiving HIV, STD, and pregnancy prevention curriculum~HIV, STD, Pregnancy Prevention Curriculum: This HIV, STD, and pregnancy intervention program entitled, It's Your Game...Keep it Real, consists of 12 lessons delivered in Grades 7 and 8. In each grade, the program integrates group-based classroom activities (e.g., role plays, group discussion, small group activities) with personalized journaling and individual tailored activities delivered on laptop computers. A life skills decision-making paradigm (Select, Detect, Protect) underlies the activities, teaching students to select personal limits regarding risk behaviors, to detect signs or situations that might challenge these limits, and to use refusal skills and other tactics to protect these limits."
1229178|NCT00161382|O2|Outcome|Control Group|No intervention: Control curriculum consists of standard sexual education.
1229179|NCT00161382|O1|Outcome|Intervention Group|"Participants receiving HIV, STD, and pregnancy prevention curriculum~HIV, STD, Pregnancy Prevention Curriculum: This HIV, STD, and pregnancy intervention program entitled, It's Your Game...Keep it Real, consists of 12 lessons delivered in Grades 7 and 8. In each grade, the program integrates group-based classroom activities (e.g., role plays, group discussion, small group activities) with personalized journaling and individual tailored activities delivered on laptop computers. A life skills decision-making paradigm (Select, Detect, Protect) underlies the activities, teaching students to select personal limits regarding risk behaviors, to detect signs or situations that might challenge these limits, and to use refusal skills and other tactics to protect these limits."
1229180|NCT00161382|E2|Reported Event|Control Group|No intervention: Control curriculum consists of standard sexual education.
1229181|NCT00161382|E1|Reported Event|Intervention Group|"Participants receiving HIV, STD, and pregnancy prevention curriculum~HIV, STD, Pregnancy Prevention Curriculum: This HIV, STD, and pregnancy intervention program entitled, It's Your Game...Keep it Real, consists of 12 lessons delivered in Grades 7 and 8. In each grade, the program integrates group-based classroom activities (e.g., role plays, group discussion, small group activities) with personalized journaling and individual tailored activities delivered on laptop computers. A life skills decision-making paradigm (Select, Detect, Protect) underlies the activities, teaching students to select personal limits regarding risk behaviors, to detect signs or situations that might challenge these limits, and to use refusal skills and other tactics to protect these limits."
1229182|NCT00161213|B1|Baseline|Gemcitabine and Imatinib|"imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.~gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days."
1229183|NCT00161213|P1|Participant Flow|Gemcitabine and Imatinib|"imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.~gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days."
1229184|NCT00161213|O1|Outcome|Gemcitabine and Imatinib|"imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.~gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days."
1229185|NCT00161213|O1|Outcome|Gemcitabine and Imatinib|"imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.~gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days."
1229186|NCT00161213|O1|Outcome|Gemcitabine and Imatinib|"imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.~gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days."
1229187|NCT00161213|O1|Outcome|Gemcitabine and Imatinib|"imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.~gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days."
1229188|NCT00161213|E1|Reported Event|Gemcitabine and Imatinib|"imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.~gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days."
1229189|NCT00160706|B1|Baseline|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
1229190|NCT00160706|P1|Participant Flow|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
1229191|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
1229192|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
1229193|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
1229194|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
1229195|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
1229196|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
1229197|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
1229198|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
1229199|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
1229200|NCT00160706|E1|Reported Event|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
1229201|NCT00160693|B1|Baseline|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
1229202|NCT00160693|P1|Participant Flow|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
1229203|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
1229204|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
1229205|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
1229206|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
1229207|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
1229208|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
1229209|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
1229210|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
1229211|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
1229212|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
1229213|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
1229214|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
1229215|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
1229216|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
1241038|NCT00117949|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
1229218|NCT00160641|B1|Baseline|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1229219|NCT00160641|P1|Participant Flow|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1229220|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1229221|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1229222|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1229223|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1229224|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1229225|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1229226|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1229227|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1229228|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1229229|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1229230|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1229231|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1229232|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1229233|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1229234|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1229235|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1229236|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1229237|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1229238|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1229239|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1229240|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1229241|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1229242|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1229243|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1229244|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1229245|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1229246|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1229247|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1229248|NCT00160641|E1|Reported Event|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
1229249|NCT00160563|B4|Baseline|Total|Total of all reporting groups
1229250|NCT00160563|B3|Baseline|PLC-PLC|Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC)
1229251|NCT00160563|B2|Baseline|LCTZ-PLC|Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC)
1229252|NCT00160563|B1|Baseline|LCTZ-LCTZ|Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ)
1229253|NCT00160563|P3|Participant Flow|PLC-PLC|Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC)
1229254|NCT00160563|P2|Participant Flow|LCTZ-PLC|Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC)
1229255|NCT00160563|P1|Participant Flow|LCTZ-LCTZ|Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ)
1229256|NCT00160563|O3|Outcome|PLC-PLC|Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC)
1229257|NCT00160563|O2|Outcome|LCTZ-PLC|Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC)
1229258|NCT00160563|O1|Outcome|LCTZ-LCTZ|Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ)
1229259|NCT00160563|O3|Outcome|PLC-PLC|Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC)
1229260|NCT00160563|O2|Outcome|LCTZ-PLC|Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC)
1229261|NCT00160563|O1|Outcome|LCTZ-LCTZ|Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ)
1229262|NCT00160563|E4|Reported Event|PLC-LCTZ|Levocetirizine after having been randomized to Placebo in the preceding A00309 trial (PLC-LCTZ) erroneously (Patient 016/1709)
1229263|NCT00160563|E3|Reported Event|PLC-PLC|Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC)
1229264|NCT00160563|E2|Reported Event|LCTZ-PLC|Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC)
1229265|NCT00160563|E1|Reported Event|LCTZ-LCTZ|Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ)
1229266|NCT00160524|B1|Baseline|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
1229267|NCT00160524|P1|Participant Flow|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
1229268|NCT00160524|O1|Outcome|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
1229269|NCT00160524|O1|Outcome|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
1229270|NCT00160524|O1|Outcome|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
1229271|NCT00160524|O1|Outcome|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
1229272|NCT00160524|O1|Outcome|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
1229273|NCT00160524|O1|Outcome|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
1229274|NCT00160524|O1|Outcome|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
1229275|NCT00160524|O1|Outcome|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
1229401|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229276|NCT00160524|E1|Reported Event|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
1229277|NCT00160251|B7|Baseline|Total|Total of all reporting groups
1229278|NCT00160251|B6|Baseline|Arm 7: PEG + BOC 800|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229279|NCT00160251|B5|Baseline|Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229280|NCT00160251|B4|Baseline|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229281|NCT00160251|B3|Baseline|Arm 3: PEG + BOC 200 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229282|NCT00160251|B2|Baseline|Arm 2: PEG + BOC 100 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229283|NCT00160251|B1|Baseline|Arm 1A: PEG + RBV OR Arm 1B: PEG + RBV + BOC 400|"Arm 1A: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If participant was HCV-RNA negative, PEG + RBV was continued for another 36 weeks.~Arm 1B: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period."
1229284|NCT00160251|P8|Participant Flow|Arm 8: PEG + RBV + BOC 800|By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.
1229285|NCT00160251|P7|Participant Flow|Arm 7: PEG + BOC 800|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229286|NCT00160251|P6|Participant Flow|ARM 4+6: PEG + BOC 400 (24 + 48 Weeks)|A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229287|NCT00160251|P5|Participant Flow|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229288|NCT00160251|P4|Participant Flow|Arm 3: PEG + BOC 200 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229289|NCT00160251|P3|Participant Flow|Arm 2: PEG + BOC 100 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229290|NCT00160251|P2|Participant Flow|Arm 1B: PEG + RBV + BOC|A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229291|NCT00160251|P1|Participant Flow|Arm 1A: PEG + RBV|A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229292|NCT00160251|O6|Outcome|Arm 7: PEG + BOC 800|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229293|NCT00160251|O5|Outcome|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229294|NCT00160251|O4|Outcome|Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229295|NCT00160251|O3|Outcome|Arm 3: PEG + BOC 200 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229296|NCT00160251|O2|Outcome|Arm 2: PEG + BOC 100 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229297|NCT00160251|O1|Outcome|Arm 1B: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229298|NCT00160251|O8|Outcome|Missing Data|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
1229299|NCT00160251|O7|Outcome|Log Drop ≥5|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
1229300|NCT00160251|O6|Outcome|Log Drop 4 to <5|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
1229301|NCT00160251|O5|Outcome|Log Drop 3 to <4|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
1229402|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229302|NCT00160251|O4|Outcome|Log Drop 2 to <3|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
1229303|NCT00160251|O3|Outcome|Log Drop 1 to <2|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
1229304|NCT00160251|O2|Outcome|Log Drop 0 to <1|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
1229305|NCT00160251|O1|Outcome|Log Drop <0|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
1229306|NCT00160251|O5|Outcome|Log Drop ≥5|Arm 5: A single dose of PEG first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By protocol amendment 2, participants were switched to an increased dose of BOC 800 plus RBV with PEG for an additional 24 Weeks of Treatment.
1229307|NCT00160251|O4|Outcome|Log Drop 4 to <5|Arm 5: A single dose of PEG first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By protocol amendment 2, participants were switched to an increased dose of BOC 800 plus RBV with PEG for an additional 24 Weeks of Treatment.
1229308|NCT00160251|O3|Outcome|Log Drop 3 to <4|Arm 5: A single dose of PEG first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By protocol amendment 2, participants were switched to an increased dose of BOC 800 plus RBV with PEG for an additional 24 Weeks of Treatment.
1229309|NCT00160251|O2|Outcome|Log Drop 2 to <3|Arm 5: A single dose of PEG first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By protocol amendment 2, participants were switched to an increased dose of BOC 800 plus RBV with PEG for an additional 24 Weeks of Treatment.
1229310|NCT00160251|O1|Outcome|Log Drop 1 to <2|Arm 5: A single dose of PEG first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By protocol amendment 2, participants were switched to an increased dose of BOC 800 plus RBV with PEG for an additional 24 Weeks of Treatment.
1229311|NCT00160251|O6|Outcome|Log Drop ≥5|All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 [48 weeks]) and Arm 6 (PEG+BOC 400 [24 weeks]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.
1229312|NCT00160251|O5|Outcome|Log Drop 4 to <5|All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 [48 weeks]) and Arm 6 (PEG+BOC 400 [24 weeks]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.
1229313|NCT00160251|O4|Outcome|Log Drop 3 to <4|All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 [48 weeks]) and Arm 6 (PEG+BOC 400 [24 weeks]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.
1229314|NCT00160251|O3|Outcome|Log Drop 2 to <3|All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 [48 weeks]) and Arm 6 (PEG+BOC 400 [24 weeks]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.
1229315|NCT00160251|O2|Outcome|Log Drop 1 to <2|All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 [48 weeks]) and Arm 6 (PEG+BOC 400 [24 weeks]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.
1229316|NCT00160251|O1|Outcome|Log Drop 0 to <1|All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 [48 weeks]) and Arm 6 (PEG+BOC 400 [24 weeks]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.
1229317|NCT00160251|O8|Outcome|Arm 8: PEG + RBV + BOC 800|By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.
1229318|NCT00160251|O7|Outcome|Arm 7: PEG + BOC 800|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229319|NCT00160251|O6|Outcome|Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229320|NCT00160251|O5|Outcome|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229321|NCT00160251|O4|Outcome|Arm 3: PEG + BOC 200|A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229322|NCT00160251|O3|Outcome|Arm 2: PEG + BOC 100 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229323|NCT00160251|O2|Outcome|Arm 1B: PEG + RBV + BOC 400|Arm 1B: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229324|NCT00160251|O1|Outcome|Arm 1A: PEG + RBV|Arm 1A: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If participant was HCV-RNA negative, PEG + RBV was continued for another 36 weeks.
1229325|NCT00160251|O4|Outcome|BOC 800 mg Dose|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800 or PEG + RBV + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229326|NCT00160251|O3|Outcome|BOC 400 mg Dose|A single dose of PEG was given first, followed 1 week later by Arms 1B, 4, 5, 6, or 7. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229327|NCT00160251|O2|Outcome|BOC 200 mg Dose|A single dose of PEG was given first, followed 1 week later by Arm 3 (PEG + BOC 200). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229328|NCT00160251|O1|Outcome|BOC 100 mg Dose|A single dose of PEG was given first, followed 1 week later by Arm 2 (PEG + BOC 100). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229329|NCT00160251|O4|Outcome|BOC 800 mg Dose|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800 or PEG + RBV + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229330|NCT00160251|O3|Outcome|BOC 400 mg Dose|A single dose of PEG was given first, followed 1 week later by Arms 1B, 4, 5, 6, or 7. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229331|NCT00160251|O2|Outcome|BOC 200 mg Dose|A single dose of PEG was given first, followed 1 week later by Arm 3 (PEG + BOC 200). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229332|NCT00160251|O1|Outcome|BOC 100 mg Dose|A single dose of PEG was given first, followed 1 week later by Arm 2 (PEG + BOC 100). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229333|NCT00160251|O4|Outcome|BOC 800 mg Dose|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800 or PEG + RBV + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229334|NCT00160251|O3|Outcome|BOC 400 mg Dose|A single dose of PEG was given first, followed 1 week later by Arms 1B, 4, 5, 6, or 7. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229335|NCT00160251|O2|Outcome|BOC 200 mg Dose|A single dose of PEG was given first, followed 1 week later by Arm 3 (PEG + BOC 200). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229336|NCT00160251|O1|Outcome|BOC 100 mg Dose|A single dose of PEG was given first, followed 1 week later by Arm 2 (PEG + BOC 100). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229337|NCT00160251|O6|Outcome|Arm 7: PEG + BOC 800|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229338|NCT00160251|O5|Outcome|Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229339|NCT00160251|O4|Outcome|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229340|NCT00160251|O3|Outcome|Arm 3: PEG + BOC 200 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229341|NCT00160251|O2|Outcome|Arm 2: PEG + BOC 100 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229342|NCT00160251|O1|Outcome|Arm 1A: PEG + RBV and Arm 1B: PEG + RBV + BOC 400|"Arm 1A: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If participant was HCV-RNA negative, PEG + RBV was continued for another 36 weeks.~Arm 1B: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period."
1229343|NCT00160251|O3|Outcome|Arm 7: PEG + BOC 800|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229344|NCT00160251|O2|Outcome|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229345|NCT00160251|O1|Outcome|Arms 2, 3, 4, 6: PEG + BOC 100, 200, or 400|A single dose of PEG was given first, followed 1 week later by PEG + BOC. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229346|NCT00160251|O4|Outcome|>12 to 36 Weeks to First Negative HCV-RNA Group|Participants who achieved first negative HCV RNA between weeks 12 to 36.
1229347|NCT00160251|O3|Outcome|>8 to 12 Weeks to First Negative HCV-RNA Group|Participants who achieved first negative HCV RNA between weeks 8 to 12.
1229348|NCT00160251|O2|Outcome|>4 to 8 Weeks to First Negative HCV-RNA Group|Participants who achieved first negative HCV RNA between weeks 4 to 8.
1229349|NCT00160251|O1|Outcome|0 to ≤ 4 Weeks to First Negative HCV-RNA Group|Participants who achieved first negative HCV RNA within the first 4 weeks of treatment.
1229350|NCT00160251|O6|Outcome|Arm 7: PEG + BOC 800|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229351|NCT00160251|O5|Outcome|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229352|NCT00160251|O4|Outcome|Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229353|NCT00160251|O3|Outcome|Arm 3: PEG + BOC 200 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229354|NCT00160251|O2|Outcome|Arm 2: PEG + BOC 100 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229355|NCT00160251|O1|Outcome|Arm 1B: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229356|NCT00160251|E8|Reported Event|PEG + RBV + BOC 800|Arm 8: By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.
1229357|NCT00160251|E7|Reported Event|PEG + BOC 800 (24 Weeks)|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229358|NCT00160251|E6|Reported Event|PEG + BOC 400 (24 + 48 Weeks)|Arms 4 + 6: A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229359|NCT00160251|E5|Reported Event|PEG + RBV + BOC 400 (48 Weeks)|Arm 5: A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229360|NCT00160251|E4|Reported Event|PEG + BOC 200 (48 Weeks)|Arm 3: A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229361|NCT00160251|E3|Reported Event|PEG + BOC 100 (48 Weeks)|Arm 2: A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229362|NCT00160251|E2|Reported Event|PEG + RBV + BOC 400 (24 Weeks)|Arm 1B: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
1229363|NCT00160251|E1|Reported Event|PEG + RBV|Arm 1A: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If participant was HCV-RNA negative, PEG + RBV was continued for another 36 weeks.
1229364|NCT00160199|B3|Baseline|Total|Total of all reporting groups
1229365|NCT00160199|B2|Baseline|Prometrium 400 mg/Day|
1229366|NCT00160199|B1|Baseline|Prometrium 300 mg/Day|
1229367|NCT00160199|P2|Participant Flow|Prometrium 400 mg/Day|
1229368|NCT00160199|P1|Participant Flow|Prometrium 300 mg/Day|
1229369|NCT00160199|O2|Outcome|Prometrium 400 mg/Day|
1229370|NCT00160199|O1|Outcome|Prometrium 300 mg/Day|
1229371|NCT00160199|O2|Outcome|Prometrium 400 mg/Day|
1229372|NCT00160199|O1|Outcome|Prometrium 300 mg/Day|
1229373|NCT00160199|O2|Outcome|Prometrium 400 mg/Day|
1229374|NCT00160199|O1|Outcome|Prometrium 300 mg/Day|
1229375|NCT00160199|O2|Outcome|Prometrium 400 mg/Day|
1229376|NCT00160199|O1|Outcome|Prometrium 300 mg/Day|
1229377|NCT00160199|O2|Outcome|Prometrium 400 mg/Day|
1229378|NCT00160199|O1|Outcome|Prometrium 300 mg/Day|
1229379|NCT00160199|O2|Outcome|Prometrium 400 mg/Day|
1229380|NCT00160199|O1|Outcome|Prometrium 300 mg/Day|
1229381|NCT00160199|O2|Outcome|Prometrium 400 mg/Day|
1229382|NCT00160199|O1|Outcome|Prometrium 300 mg/Day|
1229383|NCT00160199|E2|Reported Event|Prometrium 400 mg/Day|
1229384|NCT00160199|E1|Reported Event|Prometrium 300 mg/Day|
1229385|NCT00159965|B3|Baseline|Total|Total of all reporting groups
1229386|NCT00159965|B2|Baseline|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229387|NCT00159965|B1|Baseline|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229388|NCT00159965|P2|Participant Flow|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229389|NCT00159965|P1|Participant Flow|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229390|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229391|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229392|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229393|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229394|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229395|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229396|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229397|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229398|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229399|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229400|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229403|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229404|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229405|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229406|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229407|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229408|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229409|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229410|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229411|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229412|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229413|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229414|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229415|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229416|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229417|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229418|NCT00159965|E2|Reported Event|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229419|NCT00159965|E1|Reported Event|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
1229420|NCT00159913|B5|Baseline|Total|Total of all reporting groups
1229421|NCT00159913|B4|Baseline|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
1229422|NCT00159913|B3|Baseline|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
1229423|NCT00159913|B2|Baseline|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
1229424|NCT00159913|B1|Baseline|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
1229425|NCT00159913|P4|Participant Flow|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
1229426|NCT00159913|P3|Participant Flow|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
1229427|NCT00159913|P2|Participant Flow|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
1229428|NCT00159913|P1|Participant Flow|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
1229429|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
1229430|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
1229431|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
1229432|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
1229433|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
1229434|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
1229435|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
1229436|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
1229437|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
1229470|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
1229438|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
1229439|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
1229440|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
1229441|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
1229442|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
1229443|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
1229444|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
1229445|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
1229446|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
1229447|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
1229448|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
1229449|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
1229450|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
1229451|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
1229452|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
1229453|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
1229454|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
1229455|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
1229456|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
1229457|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
1229458|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
1229459|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
1229460|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
1229461|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
1229462|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
1229463|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
1229464|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
1229465|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
1229466|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
1229467|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
1229468|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
1229469|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
1229471|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
1229472|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
1229473|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
1229474|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
1229475|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
1229476|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
1229477|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
1229478|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
1229479|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
1229480|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
1229481|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
1229482|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
1229483|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
1229484|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
1229485|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
1229486|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
1229487|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
1229488|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
1229489|NCT00159913|E5|Reported Event|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
1229490|NCT00159913|E4|Reported Event|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
1229491|NCT00159913|E3|Reported Event|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
1229492|NCT00159913|E2|Reported Event|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
1229493|NCT00159913|E1|Reported Event|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
1229494|NCT00159874|B8|Baseline|Total|Total of all reporting groups
1229495|NCT00159874|B7|Baseline|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
1229496|NCT00159874|B6|Baseline|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
1229497|NCT00159874|B5|Baseline|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
1229498|NCT00159874|B4|Baseline|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
1229499|NCT00159874|B3|Baseline|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229500|NCT00159874|B2|Baseline|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229501|NCT00159874|B1|Baseline|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229502|NCT00159874|P7|Participant Flow|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
1229731|NCT00159783|O2|Outcome|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
1229503|NCT00159874|P6|Participant Flow|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
1229504|NCT00159874|P5|Participant Flow|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
1229505|NCT00159874|P4|Participant Flow|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
1229506|NCT00159874|P3|Participant Flow|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229507|NCT00159874|P2|Participant Flow|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229508|NCT00159874|P1|Participant Flow|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229509|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
1229510|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
1229511|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
1229512|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
1229513|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
1229514|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
1229515|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
1229516|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
1229517|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
1229518|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
1229519|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229520|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229521|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229522|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
1229523|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
1229524|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
1229525|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
1229526|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229527|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229528|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229529|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
1229530|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
1229531|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
1229532|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
1229533|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229534|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229535|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229536|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
1229537|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
1229538|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
1229539|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
1229540|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
1229541|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
1229542|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
1229543|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
1229544|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
1229545|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
1229546|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
1229547|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
1229548|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
1229549|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
1229550|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
1229551|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
1229552|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229553|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229554|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229555|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
1229556|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
1229557|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
1229558|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
1229559|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
1230264|NCT00156533|O3|Outcome|Intermittant Zolpidem|Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed)
1229560|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
1229561|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
1229562|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
1229563|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
1229564|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
1229565|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
1229566|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
1229567|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
1229568|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229569|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229570|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229571|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
1229572|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
1229573|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
1229574|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
1229575|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229576|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229577|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229578|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
1229579|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
1229580|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
1229581|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
1229582|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229583|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229584|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229585|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
1229586|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
1229587|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
1229588|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
1229589|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
1229590|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
1229591|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
1241039|NCT00117949|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
1229592|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229593|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229594|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
1229595|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
1229596|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
1229597|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
1229598|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229599|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229600|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229601|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
1229602|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
1229603|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
1229604|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229605|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229606|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229607|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
1229608|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
1229609|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
1229610|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
1229611|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229612|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229613|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229614|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
1229615|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
1229616|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
1229617|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
1229618|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229619|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229620|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229621|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
1229622|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
1229623|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
1229624|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
1229625|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229626|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229627|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229628|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
1241040|NCT00117949|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
1229629|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
1229630|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
1229631|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
1229632|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229633|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229634|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229635|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
1229636|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
1229637|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
1229638|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
1229639|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
1229640|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
1229641|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
1229642|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
1229643|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
1229644|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
1229645|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
1229646|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
1229647|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
1229648|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229649|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229650|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229651|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
1229652|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
1229653|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
1229654|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
1229655|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229656|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229657|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229658|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
1230265|NCT00156533|O2|Outcome|QHS Zolpidem|QHS (i.e., nightly) dosing with 10mg of zolpidem
1229659|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
1229660|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
1229661|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
1229662|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229663|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229664|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229665|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
1229666|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
1229667|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
1229668|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
1229669|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229670|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229671|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
1229672|NCT00159874|E3|Reported Event|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
1229673|NCT00159874|E2|Reported Event|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
1229674|NCT00159874|E1|Reported Event|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
1229675|NCT00159861|B3|Baseline|Total|Total of all reporting groups
1229676|NCT00159861|B2|Baseline|Sildenafil/Sildenafil|Study A1481141: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study A1481153: Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
1229677|NCT00159861|B1|Baseline|Placebo/Sildenafil|Core Study: Placebo; Extension Study: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
1229678|NCT00159861|P2|Participant Flow|Sildenafil: Core Study / Sildenafil: Extension Study|Core Study (16 weeks, or at least 4 weeks for subjects who required a change in epoprostenol dose due to clinical deterioration): Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study (until last enrolled subject completed 3 years of treatment): Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
1229679|NCT00159861|P1|Participant Flow|Placebo: Core Study / Sildenafil: Extension Study|Core Study: Placebo (16 weeks, or at least 4 weeks for subjects who required a change in epoprostenol dose due to clinical deterioration); Extension Study: Sildenafil (until last enrolled subject completed 3 years of treatment) - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
1229680|NCT00159861|O2|Outcome|Sldenafil/Sildenafil|Core Study A1481141: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study A1481153: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
1229681|NCT00159861|O1|Outcome|Placebo/Sildenafil|Core Study A1481141: Placebo TID (3 times daily); Extension Study A1481153: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
1229682|NCT00159861|O2|Outcome|Sildenafil/Sildenafil|Core Study: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study: Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
1229683|NCT00159861|O1|Outcome|Placebo/Sildenafil|Core Study: Placebo; Extension Study: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
1229684|NCT00159861|O2|Outcome|Sildenafil/Sildenafil|Core Study: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study: Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
1229685|NCT00159861|O1|Outcome|Placebo/Sildenafil|Core Study: Placebo; Extension Study: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
1229686|NCT00159861|O2|Outcome|Sildenafil/Sildenafil|Core Study: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study: Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
1229687|NCT00159861|O1|Outcome|Placebo/Sildenafil|Core Study: Placebo; Extension Study: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
1229688|NCT00159861|O2|Outcome|Sildenafil/Sildenafil|Core Study: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study: Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
1229689|NCT00159861|O1|Outcome|Placebo/Sildenafil|Core Study: Placebo; Extension Study: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
1229690|NCT00159861|O2|Outcome|Sildenafil/Sildenafil|Core Study: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study: Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
1229691|NCT00159861|O1|Outcome|Placebo/Sildenafil|Core Study: Placebo; Extension Study: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
1229692|NCT00159861|O2|Outcome|Sildenafil/Sildenafil|Core Study: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study: Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
1229693|NCT00159861|O1|Outcome|Placebo/Sildenafil|Core Study: Placebo; Extension Study: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
1229694|NCT00159861|O1|Outcome|All Subjects|Core Study A1481141: Placebo or Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study A1481153: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator.
1229695|NCT00159861|O1|Outcome|All Subjects|Core Study A1481141: Placebo or Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study A1481153: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
1229696|NCT00159861|E3|Reported Event|Placebo/Discontinued|Core Study (16 weeks, or at least 4 weeks for subjects who required a change in epoprostenol dose due to clinical deterioration): Placebo; Extension Study (until last enrolled subject completed 3 years of treatment): Discontinued
1229697|NCT00159861|E2|Reported Event|Sildenafil/Sildenafil|Core Study (16 weeks, or at least 4 weeks for subjects who required a change in epoprostenol dose due to clinical deterioration): Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study (until last enrolled subject completed 3 years of treatment): Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
1229698|NCT00159861|E1|Reported Event|Placebo/Sildenafil|Core Study (16 weeks, or at least 4 weeks for subjects who required a change in epoprostenol dose due to clinical deterioration): Placebo; Extension Study (until last enrolled subject completed 3 years of treatment): Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
1229699|NCT00159822|B1|Baseline|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
1229700|NCT00159822|P1|Participant Flow|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
1229701|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
1229702|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
1229703|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
1229704|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
1229705|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
1230266|NCT00156533|O1|Outcome|Placebo|QHS (i.e., nightly) dosing with placebo
1229706|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
1229707|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
1229708|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
1229709|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
1229710|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
1229711|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
1229712|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
1229713|NCT00159822|E1|Reported Event|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
1229714|NCT00159783|B4|Baseline|Total|Total of all reporting groups
1229715|NCT00159783|B3|Baseline|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
1229716|NCT00159783|B2|Baseline|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
1229717|NCT00159783|B1|Baseline|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
1229718|NCT00159783|P3|Participant Flow|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
1229719|NCT00159783|P2|Participant Flow|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
1229720|NCT00159783|P1|Participant Flow|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
1229721|NCT00159783|O3|Outcome|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
1229722|NCT00159783|O2|Outcome|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
1229723|NCT00159783|O1|Outcome|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
1229724|NCT00159783|O3|Outcome|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
1229725|NCT00159783|O2|Outcome|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
1229726|NCT00159783|O1|Outcome|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
1229727|NCT00159783|O3|Outcome|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
1229728|NCT00159783|O2|Outcome|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
1229729|NCT00159783|O1|Outcome|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
1229730|NCT00159783|O3|Outcome|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
1230267|NCT00156533|E4|Reported Event|CTRL|Monitor only condition.
1229732|NCT00159783|O1|Outcome|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
1229733|NCT00159783|O3|Outcome|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
1229734|NCT00159783|O2|Outcome|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
1229735|NCT00159783|O1|Outcome|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
1229736|NCT00159783|O3|Outcome|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
1229737|NCT00159783|O2|Outcome|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
1229738|NCT00159783|O1|Outcome|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
1229739|NCT00159783|O3|Outcome|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
1229740|NCT00159783|O2|Outcome|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
1229741|NCT00159783|O1|Outcome|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
1229742|NCT00159783|O1|Outcome|All Treatment Groups|Asenapine 5-10 mg twice daily for 40 weeks or Olanzapine 5-20 mg daily for 40 weeks
1229743|NCT00159783|O3|Outcome|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
1229744|NCT00159783|O2|Outcome|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
1229745|NCT00159783|O1|Outcome|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
1229746|NCT00159783|E3|Reported Event|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
1229747|NCT00159783|E2|Reported Event|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
1229748|NCT00159783|E1|Reported Event|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
1229749|NCT00159432|B1|Baseline|Oxaliplatin Followed by Bevacizumab, With Capecitabine|oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
1229750|NCT00159432|P1|Participant Flow|Oxaliplatin Followed by Bevacizumab, With Capecitabine|oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
1229751|NCT00159432|O1|Outcome|Oxaliplatin Followed by Bevacizumab, With Capecitabine|oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
1229752|NCT00159432|O1|Outcome|Oxaliplatin Followed by Bevacizumab, With Capecitabine|oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
1229753|NCT00159432|E1|Reported Event|Oxaliplatin Followed by Bevacizumab, With Capecitabine|oxaliplatin 85/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
1229754|NCT00159419|B3|Baseline|Total|Total of all reporting groups
1229755|NCT00159419|B2|Baseline|Alendronate Treatment|
1229756|NCT00159419|B1|Baseline|Pamidronate Treatment|
1229757|NCT00159419|P2|Participant Flow|Alendronate Treatment|
1229758|NCT00159419|P1|Participant Flow|Pamidronate Treatment|
1229759|NCT00159419|O2|Outcome|Alendronate|
1229760|NCT00159419|O1|Outcome|Pamidronate Treatment|
1229761|NCT00159419|E2|Reported Event|Alendronate Treatment|
1229762|NCT00159419|E1|Reported Event|Pamidronate Treatment|Acute phase reaction with infusion
1229763|NCT00158925|B1|Baseline|EASYTRAK EPI Lead|"Subjects in this arm will be implanted or attempted with the EASYTRAK EPI lead.~EASYTRAK EPI lead: EASYTRAK EPI lead"
1229764|NCT00158925|P1|Participant Flow|EASYTRAK EPI Implant Group|This is a single arm study, all study subjects are to be implanted in 1 arm: the EASYTRAK EPI Implant Group.
1229765|NCT00158925|O1|Outcome|EASYTRAK EPI Implant Group|This is a single arm study, all study subjects are to be implanted in 1 arm: the EASYTRAK EPI Implant Group.
1229766|NCT00158925|O1|Outcome|EASYTRAK EPI Implant Group|This is a single arm study, all study subjects are to be implanted in 1 arm: the EASYTRAK EPI Implant Group.
1229767|NCT00158925|O1|Outcome|EASYTRAK EPI Implant Group|This is a single arm study, all study subjects are to be implanted in 1 arm: the EASYTRAK EPI Implant Group.
1229768|NCT00158925|O1|Outcome|EASYTRAK EPI Implant Group|This is a single arm study, all study subjects are to be implanted in 1 arm: the EASYTRAK EPI Implant Group.
1229769|NCT00158925|O1|Outcome|EASYTRAK EPI Implant Group|This is a single arm study, all study subjects are to be implanted in 1 arm: the EASYTRAK EPI Implant Group.
1229770|NCT00158925|E1|Reported Event|EASYTRAK EPI Implant Group|This is a single arm study, all study subjects are to be implanted in 1 arm: the EASYTRAK EPI Implant Group.
1229771|NCT00158743|B3|Baseline|Total|Total of all reporting groups
1229772|NCT00158743|B2|Baseline|Placebo|sodium chloride placebo
1229773|NCT00158743|B1|Baseline|Digoxin Immune Fab|"Digibind treatment plus standard of care~Anti-digoxin antibody (FAB fragment): intravenous administered, dose based on weight (assuming 4ng/mL EDLF concentration). Dose every 6 hours x 48 hours."
1229774|NCT00158743|P2|Participant Flow|Placebo|sodium chloride placebo
1229775|NCT00158743|P1|Participant Flow|Digoxin Immune Fab|"Digibind treatment plus standard of care~Anti-digoxin antibody (FAB fragment): intravenous administered, dose based on weight (assuming 4ng/mL EDLF concentration). Dose every 6 hours x 48 hours."
1229776|NCT00158743|O2|Outcome|Placebo|sodium chloride placebo
1229777|NCT00158743|O1|Outcome|Digoxin Immune Fab|"Digibind treatment plus standard of care~Anti-digoxin antibody (FAB fragment): intravenous administered, dose based on weight (assuming 4ng/mL EDLF concentration). Dose every 6 hours x 48 hours."
1229778|NCT00158743|E2|Reported Event|Placebo|sodium chloride placebo
1229779|NCT00158743|E1|Reported Event|Digoxin Immune Fab|"Digibind treatment plus standard of care~Anti-digoxin antibody (FAB fragment): intravenous administered, dose based on weight (assuming 4ng/mL EDLF concentration). Dose every 6 hours x 48 hours."
1229780|NCT00158600|B3|Baseline|Total|Total of all reporting groups
1229781|NCT00158600|B2|Baseline|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
1229782|NCT00158600|B1|Baseline|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
1229783|NCT00158600|P2|Participant Flow|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
1229784|NCT00158600|P1|Participant Flow|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
1229785|NCT00158600|O1|Outcome|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
1229786|NCT00158600|O1|Outcome|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
1229787|NCT00158600|O1|Outcome|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
1229788|NCT00158600|O2|Outcome|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
1229789|NCT00158600|O1|Outcome|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
1229790|NCT00158600|O2|Outcome|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
1229791|NCT00158600|O1|Outcome|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
1229792|NCT00158600|O2|Outcome|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
1229793|NCT00158600|O1|Outcome|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
1229794|NCT00158600|O2|Outcome|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
1229795|NCT00158600|O1|Outcome|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
1229796|NCT00158600|O2|Outcome|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
1229797|NCT00158600|O1|Outcome|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
1229798|NCT00158600|E3|Reported Event|Overall|
1229799|NCT00158600|E2|Reported Event|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
1229800|NCT00158600|E1|Reported Event|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
1229801|NCT00158379|B1|Baseline|Paclitaxel|Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
1229802|NCT00158379|P1|Participant Flow|Paclitaxel|Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
1229803|NCT00158379|O1|Outcome|Paclitaxel|Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
1229804|NCT00158379|O1|Outcome|Paclitaxel|Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
1229805|NCT00158379|E1|Reported Event|Paclitaxel|Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
1229806|NCT00158262|B3|Baseline|Total|Total of all reporting groups
1229807|NCT00158262|B2|Baseline|Propranolol|Following the occurrence of an acute psychologically traumatic event, an initial dose of short-acting propranolol 40 mg orally then one hour later, long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
1229808|NCT00158262|B1|Baseline|Placebo|Following the occurrence of an acute psychologically traumatic event, an initial dose of placebo-matching short-acting propranolol 40 mg orally then one hour later, placebo-matching long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of placebo-matching long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
1229809|NCT00158262|P2|Participant Flow|Propranolol|Following the occurrence of an acute psychologically traumatic event, an initial dose of short-acting propranolol 40 mg orally then one hour later, long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
1229810|NCT00158262|P1|Participant Flow|Placebo|Following the occurrence of an acute psychologically traumatic event, an initial dose of placebo-matching short-acting propranolol 40 mg orally then one hour later, placebo-matching long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of placebo-matching long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
1229811|NCT00158262|O2|Outcome|Propranolol|Following the occurrence of an acute psychologically traumatic event, an initial dose of short-acting propranolol 40 mg orally then one hour later, long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
1229812|NCT00158262|O1|Outcome|Placebo|Following the occurrence of an acute psychologically traumatic event, an initial dose of placebo-matching short-acting propranolol 40 mg orally then one hour later, placebo-matching long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of placebo-matching long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
1241041|NCT00117949|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
1229813|NCT00158262|O2|Outcome|Propranolol|Following the occurrence of an acute psychologically traumatic event, an initial dose of short-acting propranolol 40 mg orally then one hour later, long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
1229814|NCT00158262|O1|Outcome|Placebo|Following the occurrence of an acute psychologically traumatic event, an initial dose of placebo-matching short-acting propranolol 40 mg orally then one hour later, placebo-matching long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of placebo-matching long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
1229815|NCT00158262|O2|Outcome|Propranolol|Following the occurrence of an acute psychologically traumatic event, an initial dose of short-acting propranolol 40 mg orally then one hour later, long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
1229816|NCT00158262|O1|Outcome|Placebo|Following the occurrence of an acute psychologically traumatic event, an initial dose of placebo-matching short-acting propranolol 40 mg orally then one hour later, placebo-matching long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of placebo-matching long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
1229817|NCT00158262|E2|Reported Event|Propranolol|Following the occurrence of an acute psychologically traumatic event, an initial dose of short-acting propranolol 40 mg orally then one hour later, long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
1229818|NCT00158262|E1|Reported Event|Placebo|Following the occurrence of an acute psychologically traumatic event, an initial dose of placebo-matching short-acting propranolol 40 mg orally then one hour later, placebo-matching long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of placebo-matching long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
1229819|NCT00158249|B3|Baseline|Total|Total of all reporting groups
1229820|NCT00158249|B2|Baseline|Citicoline|"2 gm/day~citicoline: 2 gm/day, 8 weeks treatment"
1229821|NCT00158249|B1|Baseline|Placebo|"matched capsules~placebo: matched for physical appearance"
1229822|NCT00158249|P2|Participant Flow|Citicoline|"2 gm/day~citicoline: 2 gm/day, 8 weeks treatment"
1229823|NCT00158249|P1|Participant Flow|Placebo|"matched capsules~placebo: matched for physical appearance"
1229824|NCT00158249|O2|Outcome|Citicoline|"2 gm/day~citicoline: 2 gm/day, 8 weeks treatment"
1229825|NCT00158249|O1|Outcome|Placebo|"matched capsules~placebo: matched for physical appearance"
1229826|NCT00158249|O2|Outcome|Citicoline|"2 gm/day~citicoline: 2 gm/day, 8 weeks treatment"
1229827|NCT00158249|O1|Outcome|Placebo|"matched capsules~placebo: matched for physical appearance"
1229828|NCT00158249|E2|Reported Event|Citicoline|"2 gm/day~citicoline: 2 gm/day, 8 weeks treatment"
1229829|NCT00158249|E1|Reported Event|Placebo|"matched capsules~placebo: matched for physical appearance"
1229830|NCT00158223|B3|Baseline|Total|Total of all reporting groups
1229831|NCT00158223|B2|Baseline|Pimozide|Participants received pimozide flexible dosing
1229832|NCT00158223|B1|Baseline|Placebo|Participants received encapsulated placebo made to match active drug
1229833|NCT00158223|P2|Participant Flow|Pimozide|Participants received pimozide flexible dosing
1229834|NCT00158223|P1|Participant Flow|Placebo|Participants received encapsulated placebo made to match active drug
1229835|NCT00158223|O2|Outcome|Pimozide|Participants received pimozide flexible dosing
1229836|NCT00158223|O1|Outcome|Placebo|Participants received encapsulated placebo made to match active drug
1229837|NCT00158223|O2|Outcome|Pimozide|Participants received pimozide flexible dosing
1229838|NCT00158223|O1|Outcome|Placebo|Participants received encapsulated placebo made to match active drug
1229839|NCT00158223|O2|Outcome|Pimozide|Participants received pimozide flexible dosing
1229840|NCT00158223|O1|Outcome|Placebo|Participants received encapsulated placebo made to match active drug
1229841|NCT00158223|E2|Reported Event|Pimozide|Participants received pimozide flexible dosing
1229842|NCT00158223|E1|Reported Event|Placebo|Participants received encapsulated placebo made to match active drug
1229843|NCT00158197|B5|Baseline|Total|Total of all reporting groups
1229844|NCT00158197|B4|Baseline|Standard|Participants assigned to the standard condition will not receive vouchers for the provision of clean urines.
1229845|NCT00158197|B3|Baseline|Intermittent Unpredictable Schedule|"Those in the intermittent unpredictable condition will be eligible to receive a voucher on one day a week. This date will be randomly determined and they will not know in advance what day it will be. Participants in this group will receive a voucher following their first three methamphetamine-negative urine tests. Following that they will be eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. The day of the week on which the voucher will be available will be randomly selected for each week and the participants will not know which day of the week they will be eligible to receive a voucher until they have provided their urine test.~contingency managment voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
1229856|NCT00158197|O4|Outcome|Standard|Participants assigned to the standard condition will not receive vouchers for the provision of clean urines.
1230269|NCT00156533|E2|Reported Event|QHS Zolpidem|QHS dosing with 10mg of zolpidem
1229846|NCT00158197|B2|Baseline|Continuous Voucher Schedule|"Those in the continuous condition will receive a voucher each time they test negative for methamphetamine. The initial voucher value will be $2.50. Each consecutive instance of abstinence will increase the magnitude of the voucher by $1.50. Three consecutive abstinences will result in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.~contingency managment voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
1229847|NCT00158197|B1|Baseline|Intermittent Predictable Schedule|"Those in the intermittent predictable condition will earn a voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition will receive $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There are no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.~contingency managment voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
1229848|NCT00158197|P4|Participant Flow|Standard|Participants assigned to the standard condition did not receive vouchers for the provision of clean urines.
1229849|NCT00158197|P3|Participant Flow|Intermittent Unpredictable Schedule|"Participants in the unpredictable intermittent condition earned vouchers of the same magnitude as those in the predictable intermittent condition and at approximately the same rate (i.e., $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second week of methamphetamine-negative urines, etc). More specifically, participants in this group received a voucher for $22.00 following their first three methamphetamine-negative urine tests. Following that they were eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. This date was randomly determined and they did not know in advance what day it was.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
1229850|NCT00158197|P2|Participant Flow|Continuous Schedule|"Those in the continuous condition received a voucher each time they tested negative for methamphetamine. The initial voucher value was $2.50. Each consecutive instance of abstinence increased the magnitude of the voucher by $1.50. Three consecutive abstinences resulted in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, resulted in a reset in the voucher magnitude back to its original level from whence the progression could begin again.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
1229851|NCT00158197|P1|Participant Flow|Intermittent Predictable Schedule|"Those in the intermittent predictable condition earned a voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition received $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There were no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, resulted in a reset in the voucher magnitude back to its original level from whence the progression can begin again.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
1229852|NCT00158197|O4|Outcome|Standard|Participants assigned to the standard condition will not receive vouchers for the provision of clean urines.
1229853|NCT00158197|O3|Outcome|Intermittent Unpredictable Schedule|"Those in the intermittent unpredictable condition will be eligible to receive a voucher on one day a week. This date will be randomly determined and they will not know in advance what day it will be. Participants in this group will receive a voucher following their first three methamphetamine-negative urine tests. Following that they will be eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. The day of the week on which the voucher will be available will be randomly selected for each week and the participants will not know which day of the week they will be eligible to receive a voucher until they have provided their urine test.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
1229854|NCT00158197|O2|Outcome|Continuous Voucher Schedule|"Those in the continuous condition will receive a voucher each time they test negative for methamphetamine. The initial voucher value will be $2.50. Each consecutive instance of abstinence will increase the magnitude of the voucher by $1.50. Three consecutive abstinences will result in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
1229855|NCT00158197|O1|Outcome|Intermittent Predictable Schedule|"Those in the intermittent predictable condition will earn a voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition will receive $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There are no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
1230270|NCT00156533|E1|Reported Event|Placebo|QHS dosing with placebo
1229857|NCT00158197|O3|Outcome|Intermittent Unpredictable Schedule|"Those in the intermittent unpredictable condition will be eligible to receive a voucher on one day a week. This date will be randomly determined and they will not know in advance what day it will be. Participants in this group will receive a voucher following their first three methamphetamine-negative urine tests. Following that they will be eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. The day of the week on which the voucher will be available will be randomly selected for each week and the participants will not know which day of the week they will be eligible to receive a voucher until they have provided their urine test.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
1229858|NCT00158197|O2|Outcome|Continuous Voucher Schedule|"Those in the continuous condition will receive a voucher each time they test negative for methamphetamine. The initial voucher value will be $2.50. Each consecutive instance of abstinence will increase the magnitude of the voucher by $1.50. Three consecutive abstinences will result in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
1229859|NCT00158197|O1|Outcome|Intermittent Predictable Schedule|"Those in the intermittent predictable condition will earn a voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition will receive $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There are no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
1229860|NCT00158197|O4|Outcome|Standard|Participants assigned to the standard condition will not receive vouchers for the provision of clean urines.
1229861|NCT00158197|O3|Outcome|Intermittent Unpredictable Schedule|"Those in the intermittent unpredictable condition will be eligible to receive a voucher on one day a week. This date will be randomly determined and they will not know in advance what day it will be. Participants in this group will receive a voucher following their first three methamphetamine-negative urine tests. Following that they will be eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. The day of the week on which the voucher will be available will be randomly selected for each week and the participants will not know which day of the week they will be eligible to receive a voucher until they have provided their urine test.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
1229862|NCT00158197|O2|Outcome|Continuous Voucher Schedule|"Those in the continuous condition will receive a voucher each time they test negative for methamphetamine. The initial voucher value will be $2.50. Each consecutive instance of abstinence will increase the magnitude of the voucher by $1.50. Three consecutive abstinences will result in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
1229863|NCT00158197|O1|Outcome|Intermittent Predictable Schedule|"Those in the intermittent predictable condition will earn a voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition will receive $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There are no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
1229864|NCT00158197|E4|Reported Event|Standard|Participants assigned to the standard condition will not receive vouchers for the provision of clean urines. All participants will provide observed urine samples three times a week (e.g., M, W, & F) for twelve weeks and will complete study-related measures one time per week.
1229865|NCT00158197|E3|Reported Event|Intermittent Unpredictable Schedule|Those in the intermittent unpredictable condition will be eligible to receive a contingency management voucher on one day a week. Participants in this group will receive a voucher for $22.00 following their first 3 methamphetamine-negative urine tests. They will then be eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. They will receive a voucher for $35.50 for the provision of their second set of 3 consecutive instances of methamphetamine-negative urine samples, $49.00 for their third set of 3 consecutive instances, and so forth. The day of the week on which the voucher will be available will be randomly selected for each week and the participants will not know which day of the week they will be eligible to receive a voucher until they have provided their urine test. All participants will provide observed urine samples M, W, & F for 12 wks and complete measures 1x/wk.
1229880|NCT00158054|O1|Outcome|Enhanced Depression Care|The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
1229866|NCT00158197|E2|Reported Event|Intermittent Predictable Schedule|Those in the intermittent predictable condition will earn a contingency management voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition will receive $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There are no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again. All participants will provide observed urine samples three times a week (e.g., M, W, & F) for twelve weeks and will complete study-related measures one time per week.
1229867|NCT00158197|E1|Reported Event|Continuous Voucher Schedule|Those in the continuous condition will receive a contingency management voucher each time they test negative for methamphetamine. The initial voucher value will be $2.50. Each consecutive instance of abstinence will increase the magnitude of the voucher by $1.50. Three consecutive abstinences will result in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again. All participants will provide observed urine samples three times a week (e.g., M, W, & F) for twelve weeks and will complete study-related measures one time per week.
1229868|NCT00158054|B3|Baseline|Total|Total of all reporting groups
1229869|NCT00158054|B2|Baseline|Referred Depression Care|The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
1229870|NCT00158054|B1|Baseline|Enhanced Depression Care|The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
1229871|NCT00158054|P2|Participant Flow|Referred Depression Care|The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
1229872|NCT00158054|P1|Participant Flow|Enhanced Depression Care|The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
1229873|NCT00158054|O2|Outcome|Referred Depression Care|The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
1229874|NCT00158054|O1|Outcome|Enhanced Depression Care|The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
1229875|NCT00158054|O2|Outcome|Referred Depression Care|The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
1229876|NCT00158054|O1|Outcome|Enhanced Depression Care|The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
1229877|NCT00158054|O2|Outcome|Referred Depression Care|The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
1229878|NCT00158054|O1|Outcome|Enhanced Depression Care|The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
1229879|NCT00158054|O2|Outcome|Referred Depression Care|The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
1229925|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
1230271|NCT00156390|B3|Baseline|Total|Total of all reporting groups
1229881|NCT00158054|E2|Reported Event|Referred Depression Care|The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
1229882|NCT00158054|E1|Reported Event|Enhanced Depression Care|The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
1229883|NCT00157950|B3|Baseline|Total|Total of all reporting groups
1229884|NCT00157950|B2|Baseline|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
1229885|NCT00157950|B1|Baseline|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
1229886|NCT00157950|P2|Participant Flow|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
1229887|NCT00157950|P1|Participant Flow|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
1229888|NCT00157950|O2|Outcome|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
1229889|NCT00157950|O1|Outcome|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
1229890|NCT00157950|O2|Outcome|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
1229891|NCT00157950|O1|Outcome|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
1229892|NCT00157950|O2|Outcome|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
1229893|NCT00157950|O1|Outcome|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
1229894|NCT00157950|O2|Outcome|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
1229895|NCT00157950|O1|Outcome|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
1229896|NCT00157950|O2|Outcome|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
1229897|NCT00157950|O1|Outcome|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
1229898|NCT00157950|E2|Reported Event|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
1229899|NCT00157950|E1|Reported Event|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
1229900|NCT00157820|B4|Baseline|Total|Total of all reporting groups
1229901|NCT00157820|B3|Baseline|DC True Then SC Sim|"Dual chamber ICD initially programmed as a DDED-DDDR (DC true arm) then programmed as Single Chamber simulated"
1229902|NCT00157820|B2|Baseline|SC Simulated Then DC True|Dual chamber ICD initially programmed as Single Chamber ICD (simulated) then DC true programmed as Dual Chamber true (DDED-DDDR) NASPE/BPEG Defibrillator/Pacemaker Codes.
1229903|NCT00157820|B1|Baseline|SC True|Allocated to Single Chamber ICD (SC true arm) VVEV-VVI (NASPE/BPEG Defibrillator/Pacemaker Codes)
1229904|NCT00157820|P3|Participant Flow|DC True Then SC Sim|"Dual chamber ICD initially programmed as a DDED-DDDR (DC true arm) then programmed as Single Chamber simulated"
1229905|NCT00157820|P2|Participant Flow|SC Simulated Then DC True|Dual chamber ICD initially programmed as Single Chamber ICD (simulated) then DC true programmed as Dual Chamber true (DDED-DDDR) NASPE/BPEG Defibrillator/Pacemaker Codes.
1229906|NCT00157820|P1|Participant Flow|SC True|Allocated to Single Chamber ICD (SC true arm) VVEV-VVI (NASPE/BPEG Defibrillator/Pacemaker Codes)
1229907|NCT00157820|O3|Outcome|DC True|"Dual chamber ICD initially programmed as a DDED-DDDR (DC true arm)"
1229908|NCT00157820|O2|Outcome|SC Simulated|Dual chamber ICD initially programmed as Single Chamber ICD (simulated)
1229909|NCT00157820|O1|Outcome|SC True|Allocated to Single Chamber ICD (SC true arm)
1229910|NCT00157820|O3|Outcome|DC True|"Dual chamber ICD initially programmed as a DDED-DDDR (DC true arm"
1229911|NCT00157820|O2|Outcome|SC Simulated|Dual chamber ICD initially programmed as Single Chamber ICD (simulated)
1229912|NCT00157820|O1|Outcome|SC True|Allocated to Single Chamber ICD (SC true arm)
1229913|NCT00157820|E3|Reported Event|DC True|"Dual chamber ICD initially programmed as a DDED-DDDR (DC true arm)"
1229914|NCT00157820|E2|Reported Event|SC Simulated|Dual chamber ICD initially programmed as Single Chamber ICD (simulated
1229915|NCT00157820|E1|Reported Event|SC True|Allocated to Single Chamber ICD (SC true arm)
1229916|NCT00157755|B3|Baseline|Total|Total of all reporting groups
1229917|NCT00157755|B2|Baseline|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
1229918|NCT00157755|B1|Baseline|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
1229919|NCT00157755|P6|Participant Flow|Idiopathic: Not Randomized|This group contains subjects that were enrolled and analyzed as part of the idiopathic cohort. These subjects exited the study prior to randomization at 1.5 months.
1229920|NCT00157755|P5|Participant Flow|Idiopathic: OFF First, Then ON|This group contains subjects that were enrolled and analyzed as part of the idiopathic cohort. During the crossover phase of the study, this subject had the device OFF for three months, followed by device ON for three months.
1229921|NCT00157755|P4|Participant Flow|Idiopathic: ON First, Then OFF|This group contains subjects that were enrolled and analyzed as part of the idiopathic cohort. During the crossover phase of the study, this subject had the device ON for three months, followed by device OFF for three months.
1229922|NCT00157755|P3|Participant Flow|Diabetic: Not Randomized|This group contains subjects that were enrolled and analyzed as part of the diabetic cohort. These subjects exited the study prior to randomization at 1.5 months.
1229923|NCT00157755|P2|Participant Flow|Diabetic: OFF First, Then ON|This group contains subjects that were enrolled and analyzed as part of the diabetic cohort. During the crossover phase of the study, this subject had the device OFF for three months, followed by device ON for three months.
1229924|NCT00157755|P1|Participant Flow|Diabetic: ON First, Then OFF|This group contains subjects that were enrolled and analyzed as part of the diabetic cohort. During the crossover phase of the study, this subject had the device ON for three months, followed by device OFF for three months.
1229927|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
1229928|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
1229929|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
1229930|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
1229931|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
1229932|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
1229933|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
1229934|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
1229935|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
1229936|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
1229937|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
1229938|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
1229939|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
1229940|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
1229941|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
1229942|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
1229943|NCT00157755|E2|Reported Event|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
1229944|NCT00157755|E1|Reported Event|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
1229945|NCT00157573|B1|Baseline|GM-CSF, Sargramostim|"All enrolled eligible participants who participated in Cohort 1 or Cohort 2 of the study.~In Cohort 1 participants received GM-CSF, sargramostim 250 μg/m^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles.~In Cohort 2 participants received GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. GM-CSF, sargramostim dose escalation was permitted up to 250 μg/m^2 per day if applicable based on toxicity and white blood cell count."
1229946|NCT00157573|P2|Participant Flow|GM-CSF, Sargramostim Cohort 2|GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. GM-CSF, sargramostim dose escalation was permitted up to 250 μg/m^2 per day if applicable based on toxicity and the white blood cell count.
1229947|NCT00157573|P1|Participant Flow|GM-CSF, Sargramostim Cohort 1|GM-CSF, sargramostim 250 μg/m^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles.
1229948|NCT00157573|O1|Outcome|GM-CSF, Sargramostim|"All enrolled eligible participants who participated in Cohort 1 or Cohort 2 of the study.~In Cohort 1 participants received GM-CSF, sargramostim 250 μg/m^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles.~In Cohort 2 participants received GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. GM-CSF, sargramostim dose escalation was permitted up to 250 μg/m^2 per day if applicable based on toxicity and white blood cell count."
1229949|NCT00157573|O1|Outcome|GM-CSF, Sargramostim|"All enrolled eligible participants who participated in Cohort 1 or Cohort 2 of the study.~In Cohort 1 participants received GM-CSF, sargramostim 250 μg/m^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles.~In Cohort 2 participants received GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. GM-CSF, sargramostim dose escalation was permitted up to 250 μg/m^2 per day if applicable based on toxicity and white blood cell count."
1229950|NCT00157573|O1|Outcome|GM-CSF, Sargramostim|"All enrolled eligible participants who participated in Cohort 1 or Cohort 2 of the study.~In Cohort 1 participants received GM-CSF, sargramostim 250 μg/m^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles.~In Cohort 2 participants received GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. GM-CSF, sargramostim dose escalation was permitted up to 250 μg/m^2 per day if applicable based on toxicity and white blood cell count."
1229951|NCT00157573|O1|Outcome|GM-CSF, Sargramostim|"All enrolled eligible participants who participated in Cohort 1 or Cohort 2 of the study.~In Cohort 1 participants received GM-CSF, sargramostim 250 μg/m^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles.~In Cohort 2 participants received GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. GM-CSF, sargramostim dose escalation was permitted up to 250 μg/m^2 per day if applicable based on toxicity and white blood cell count."
1229952|NCT00157573|O1|Outcome|GM-CSF, Sargramostim|"All enrolled eligible participants who participated in Cohort 1 or Cohort 2 of the study.~In Cohort 1 participants received GM-CSF, sargramostim 250 μg/m^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles.~In Cohort 2 participants received GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. GM-CSF, sargramostim dose escalation was permitted up to 250 μg/m^2 per day if applicable based on toxicity and white blood cell count."
1230702|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
1229953|NCT00157573|E2|Reported Event|GM-CSF, Sargramostim Cohort 2|GM-CSF, sargramostim 150 μg/m^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. GM-CSF dose escalation was permitted up to 250 μg/m^2 per day if applicable based on toxicity and white blood cell count.
1229954|NCT00157573|E1|Reported Event|GM-CSF, Sargramostim Cohort 1|GM-CSF, sargramostim 250 μg/m^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles.
1229955|NCT00157248|B5|Baseline|Total|Total of all reporting groups
1229956|NCT00157248|B4|Baseline|Dabigatran Etexilate, 300 mg BID (Twice Daily)|Dosage used at study start
1229957|NCT00157248|B3|Baseline|Dabigatran Etexilate, 300 mg QD (Once Daily)|Dosage used at study start
1229958|NCT00157248|B2|Baseline|Dabigatran Etexilate, 150 mg BID (Twice Daily)|Dosage used at study start
1229959|NCT00157248|B1|Baseline|Dabigatran Etexilate, 150 mg QD (Once Daily)|Dosage used at study start
1229960|NCT00157248|P4|Participant Flow|Dabigatran Etexilate, 300 mg BID (Twice Daily)|Dosage used at study start
1229961|NCT00157248|P3|Participant Flow|Dabigatran Etexilate, 300 mg QD (Once Daily)|Dosage used at study start
1229962|NCT00157248|P2|Participant Flow|Dabigatran Etexilate, 150 mg BID (Twice Daily)|Dosage used at study start
1229963|NCT00157248|P1|Participant Flow|Dabigatran Etexilate, 150 mg QD (Once Daily)|Dosage used at study start
1229964|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
1229965|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
1229966|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
1229967|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
1229968|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
1229969|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
1229970|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
1229971|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
1229972|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
1229973|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
1229974|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
1229975|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
1229976|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
1229977|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
1229978|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
1229979|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
1229980|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
1229981|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
1229982|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
1229983|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
1229984|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
1229985|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
1229986|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
1229987|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
1229988|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
1229989|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
1229990|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
1229991|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
1229992|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
1229993|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
1229994|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
1229995|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
1229996|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
1229997|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
1229998|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
1229999|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
1230000|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
1230703|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
1230002|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
1230003|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
1230004|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
1230005|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
1230006|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
1230007|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
1230008|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
1230009|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
1230010|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
1230011|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
1230012|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
1230013|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
1230014|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
1230015|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
1230016|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
1230017|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
1230018|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
1230019|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
1230020|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
1230021|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
1230022|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
1230023|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
1230024|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
1230025|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
1230026|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
1230027|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
1230028|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
1230029|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
1230030|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
1230031|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
1230032|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
1230033|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
1230034|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
1230035|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
1230036|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
1230037|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
1230038|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
1230039|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
1230040|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
1230041|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
1230042|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
1230043|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
1230044|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
1230045|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
1230046|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
1230047|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
1230048|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
1230049|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
1230268|NCT00156533|E3|Reported Event|Intermittant Zolpidem|Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed
1230050|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
1230051|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
1230052|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
1230053|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
1230054|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
1230055|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
1230056|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
1230057|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
1230058|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
1230059|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
1230060|NCT00157248|E6|Reported Event|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
1230061|NCT00157248|E5|Reported Event|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
1230062|NCT00157248|E4|Reported Event|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
1230063|NCT00157248|E3|Reported Event|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
1230064|NCT00157248|E2|Reported Event|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
1230065|NCT00157248|E1|Reported Event|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
1230066|NCT00157209|B3|Baseline|Total|Total of all reporting groups
1230067|NCT00157209|B2|Baseline|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
1230068|NCT00157209|B1|Baseline|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
1230069|NCT00157209|P2|Participant Flow|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
1230070|NCT00157209|P1|Participant Flow|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
1230071|NCT00157209|O2|Outcome|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
1230072|NCT00157209|O1|Outcome|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
1230073|NCT00157209|O2|Outcome|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
1230114|NCT00157014|B3|Baseline|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
1230115|NCT00157014|B2|Baseline|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230116|NCT00157014|B1|Baseline|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230704|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
1230074|NCT00157209|O1|Outcome|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
1230075|NCT00157209|O2|Outcome|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
1230076|NCT00157209|O1|Outcome|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
1230077|NCT00157209|O2|Outcome|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
1230078|NCT00157209|O1|Outcome|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
1230079|NCT00157209|O2|Outcome|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
1230080|NCT00157209|O1|Outcome|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
1230081|NCT00157209|E2|Reported Event|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
1230082|NCT00157209|E1|Reported Event|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
1230083|NCT00157196|B1|Baseline|Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care|A single intravenous infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 mcg of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The BSC was provided at the investigator’s discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
1230117|NCT00157014|P4|Participant Flow|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
1241042|NCT00117949|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
1230084|NCT00157196|P1|Participant Flow|Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 microgram (mcg) of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The best standard of care (BSC) was provided at the investigator’s discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
1230085|NCT00157196|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care|A single intravenous infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 mcg of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The BSC was provided at the investigator’s discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
1230086|NCT00157196|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care|A single intravenous infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 mcg of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The BSC was provided at the investigator’s discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
1230087|NCT00157196|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care|A single intravenous infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 mcg of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The BSC was provided at the investigator’s discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
1230088|NCT00157196|E1|Reported Event|Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care|A single intravenous infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 mcg of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The BSC was provided at the investigator’s discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
1230089|NCT00157157|B1|Baseline|PUPs|
1230090|NCT00157157|P1|Participant Flow|Previously Untreated Patients (PUPs)|rAHF-PFM was dosed according to a therapeutic regimen which was determined by the investigator (ie: standard regimen [25 to 50 IU/kg body weight, 3 to 4 times per week]; a modified prophylactic regimen [dose and frequency selected by investigator] or on–demand treatment [dose selected by investigator]). The dosing regimen used to treat bleeding episodes (BEs) was at the discretion of the investigator and in accordance with the institution’s standard of care for the type of bleeding episodes diagnosed.
1230091|NCT00157157|O2|Outcome|PUPs - Developed Factor VIII Inhibitor|
1230092|NCT00157157|O1|Outcome|PUPs - Did Not Develop Factor VIII Inhibitor|
1230093|NCT00157157|O2|Outcome|PUPs - Developed Factor VIII Inhibitor|
1230094|NCT00157157|O1|Outcome|PUPs - Did Not Develop Factor VIII Inhibitor|
1230095|NCT00157157|O2|Outcome|PUPs - Developed Factor VIII Inhibitor|
1230096|NCT00157157|O1|Outcome|PUPs - Did Not Develop Factor VIII Inhibitor|
1230097|NCT00157157|O1|Outcome|PUPs|
1230098|NCT00157157|O1|Outcome|PUPs|
1230099|NCT00157157|O1|Outcome|PUPs|
1230100|NCT00157157|O1|Outcome|PUPs|
1230101|NCT00157157|O1|Outcome|PUPs|
1230102|NCT00157157|O2|Outcome|PUPs -Termination Visit|Incremental recovery at the Termination Study Visit
1230103|NCT00157157|O1|Outcome|PUPs -Initial Visit|Incremental recovery at the Initial Study Visit
1230104|NCT00157157|O3|Outcome|PUPs -During Perioperative Management|rAHF-PFM was administered intravenously via bolus infusion, or continuous infusion. The dosing regimen used was at the discretion of the investigator and in accordance with the institution’s standard of care.
1230105|NCT00157157|O2|Outcome|PUPs -During On-Demand Treatment|The dosing regimen used to treat BEs was at the discretion of the investigator and in accordance with the institution’s standard of care for the type of BE diagnosed.
1230106|NCT00157157|O1|Outcome|PUPs -During Prophylaxis|rAHF-PFM was dosed according to a therapeutic regimen which was determined by the investigator (ie: standard regimen [25 to 50 IU/kg body weight, 3 to 4 times per week]; a modified prophylactic regimen [dose and frequency selected by investigator]. The dosing regimen used to treat BEs was at the discretion of the investigator and in accordance with the institution’s standard of care for the type of bleeding episode (BE) diagnosed.
1230107|NCT00157157|O1|Outcome|PUPs|
1230108|NCT00157157|O1|Outcome|PUPs|
1230109|NCT00157157|O1|Outcome|PUPs|
1230110|NCT00157157|O1|Outcome|PUPs|
1230111|NCT00157157|E1|Reported Event|PUPs|
1230112|NCT00157014|B5|Baseline|Total|Total of all reporting groups
1230113|NCT00157014|B4|Baseline|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
1230118|NCT00157014|P3|Participant Flow|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
1230119|NCT00157014|P2|Participant Flow|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230120|NCT00157014|P1|Participant Flow|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230121|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
1230122|NCT00157014|O1|Outcome|Tacrolimus - Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
1230123|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
1230124|NCT00157014|O1|Outcome|Tacrolimus - Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
1230125|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
1230126|NCT00157014|O1|Outcome|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
1230127|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
1230128|NCT00157014|O1|Outcome|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
1230129|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
1230130|NCT00157014|O1|Outcome|Tacrolimus - Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
1230131|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
1230132|NCT00157014|O1|Outcome|Tacrolimus - Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
1230133|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
1230134|NCT00157014|O1|Outcome|Tacrolimus - Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
1230135|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
1230136|NCT00157014|O1|Outcome|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
1230137|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
1230138|NCT00157014|O1|Outcome|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
1230139|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
1230140|NCT00157014|O1|Outcome|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
1230141|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
1230142|NCT00157014|O1|Outcome|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
1230143|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230144|NCT00157014|O1|Outcome|Tacrolimus – Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230145|NCT00157014|O2|Outcome|Cyclosporine - Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230146|NCT00157014|O1|Outcome|Tacrolimus – Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230147|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230148|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230149|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230150|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230151|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230152|NCT00157014|O1|Outcome|Tacrolimus – Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230153|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230154|NCT00157014|O1|Outcome|Tacrolimus – Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230155|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230156|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230157|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230158|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230159|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230160|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230161|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230162|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230163|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230259|NCT00156533|O4|Outcome|CTRL|Monitor only condition.
1230164|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230165|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230166|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230167|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230168|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230169|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230170|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230171|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230172|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230173|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230174|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230175|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230176|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230177|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230178|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230179|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230180|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230181|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230182|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230183|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230184|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230185|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230186|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230187|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230188|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230189|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
1230190|NCT00157014|O1|Outcome|Tacrolimus - Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
1230191|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230192|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230193|NCT00157014|E4|Reported Event|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
1230194|NCT00157014|E3|Reported Event|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
1230195|NCT00157014|E2|Reported Event|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230196|NCT00157014|E1|Reported Event|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
1230197|NCT00156936|B3|Baseline|Total|Total of all reporting groups
1230198|NCT00156936|B2|Baseline|Oral Naltrexone to Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group switched from oral naltrexone 50 mg daily in the base study to receive VIVITROL (Medisorb naltrexone 380) mg via IM injection once every 4 weeks in this extension study.
1230199|NCT00156936|B1|Baseline|Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group received VIVITROL (Medisorb naltrexone 380 mg) via intramuscular (IM) injection once every 4 weeks throughout the base study and continued on the same regimen throughout this extension.
1230200|NCT00156936|P2|Participant Flow|Oral Naltrexone to Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group switched from oral naltrexone 50 mg daily in the base study to receive VIVITROL (Medisorb naltrexone 380) mg via IM injection once every 4 weeks in this extension study.
1230201|NCT00156936|P1|Participant Flow|Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group received VIVITROL (Medisorb naltrexone 380 mg) via intramuscular (IM) injection once every 4 weeks throughout the base study and continued on the same regimen throughout this extension.
1230202|NCT00156936|O2|Outcome|Oral Naltrexone to Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group switched from oral naltrexone 50 mg daily in the base study to receive VIVITROL (Medisorb naltrexone 380) mg via IM injection once every 4 weeks in this extension study.
1230203|NCT00156936|O1|Outcome|Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group received VIVITROL (Medisorb naltrexone 380 mg) via intramuscular (IM) injection once every 4 weeks throughout the base study and continued on the same regimen throughout this extension.
1230204|NCT00156936|E2|Reported Event|Oral Naltrexone to Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group switched from oral naltrexone 50 mg daily in the base study to receive VIVITROL (Medisorb naltrexone 380) mg via IM injection once every 4 weeks in this extension study.
1230260|NCT00156533|O3|Outcome|Intermittant Zolpidem|Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed
1230205|NCT00156936|E1|Reported Event|Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group received VIVITROL (Medisorb naltrexone 380 mg) via intramuscular (IM) injection once every 4 weeks throughout the base study and continued on the same regimen throughout this extension.
1230206|NCT00156923|B3|Baseline|Total|Total of all reporting groups
1230207|NCT00156923|B2|Baseline|Medisorb Naltrexone 190 mg|Administered via IM injection once every 4 weeks.
1230208|NCT00156923|B1|Baseline|Medisorb Naltrexone 380 mg|Administered via intramuscular (IM) injection once every 4 weeks.
1230209|NCT00156923|P2|Participant Flow|Medisorb Naltrexone 190 mg|Administered via IM injection once every 4 weeks.
1230210|NCT00156923|P1|Participant Flow|Medisorb Naltrexone 380 mg|Administered via intramuscular (IM) injection once every 4 weeks.
1230211|NCT00156923|O2|Outcome|Medisorb Naltrexone 190 mg|Administered via IM injection once every 4 weeks.
1230212|NCT00156923|O1|Outcome|Medisorb Naltrexone 380 mg|Administered via intramuscular (IM) injection once every 4 weeks.
1230213|NCT00156923|E2|Reported Event|Medisorb Naltrexone 190 mg|Administered via IM injection once every 4 weeks.
1230214|NCT00156923|E1|Reported Event|Medisorb Naltrexone 380 mg|Administered via intramuscular (IM) injection once every 4 weeks.
1230215|NCT00156910|B3|Baseline|Total|Total of all reporting groups
1230216|NCT00156910|B2|Baseline|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
1230217|NCT00156910|B1|Baseline|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
1230218|NCT00156910|P2|Participant Flow|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
1230219|NCT00156910|P1|Participant Flow|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
1230220|NCT00156910|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
1230221|NCT00156910|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
1230222|NCT00156910|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
1230223|NCT00156910|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
1230224|NCT00156910|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
1230225|NCT00156910|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
1230226|NCT00156910|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
1230227|NCT00156910|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
1230228|NCT00156910|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
1230229|NCT00156910|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
1230230|NCT00156910|E2|Reported Event|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
1230231|NCT00156910|E1|Reported Event|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
1230232|NCT00156819|B4|Baseline|Total|Total of all reporting groups
1230233|NCT00156819|B3|Baseline|Fluticasone Plus Salmeterol|"Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
1230234|NCT00156819|B2|Baseline|Montelukast|"Participants were changed to Montelukast (5 or 10 mg each night).~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
1230235|NCT00156819|B1|Baseline|Fluticasone|"Participants continued fluticasone (100 microgram twice daily) treatment.~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
1230236|NCT00156819|P3|Participant Flow|Fluticasone Plus Salmeterol|"Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
1230237|NCT00156819|P2|Participant Flow|Montelukast|"Participants were changed to Montelukast (5 or 10 mg each night).~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
1230238|NCT00156819|P1|Participant Flow|Fluticasone|"Participants continued fluticasone (100 microgram twice daily) treatment.~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
1230239|NCT00156819|O3|Outcome|Fluticasone Plus Salmeterol|"Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
1230240|NCT00156819|O2|Outcome|Montelukast|"Participants were changed to Montelukast (5 or 10 mg each night).~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
1230241|NCT00156819|O1|Outcome|Fluticasone|"Participants continued fluticasone (100 microgram twice daily) treatment.~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
1230242|NCT00156819|E3|Reported Event|Fluticasone Plus Salmeterol|"Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
1230243|NCT00156819|E2|Reported Event|Montelukast|"Participants were changed to Montelukast (5 or 10 mg each night).~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
1230244|NCT00156819|E1|Reported Event|Fluticasone|"Participants continued fluticasone (100 microgram twice daily) treatment.~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
1230245|NCT00156715|B1|Baseline|QUET|After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
1230246|NCT00156715|P1|Participant Flow|QUET|After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
1230247|NCT00156715|O1|Outcome|QUET|After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
1230248|NCT00156715|O1|Outcome|QUET|After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
1230249|NCT00156715|E1|Reported Event|QUET|After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
1230250|NCT00156533|B5|Baseline|Total|Total of all reporting groups
1230251|NCT00156533|B4|Baseline|CTRL|Monitor only condition.
1230252|NCT00156533|B3|Baseline|Intermittant Zolpidem|Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed
1230253|NCT00156533|B2|Baseline|QHS Zolpidem|QHS dosing with 10mg of zolpidem
1230254|NCT00156533|B1|Baseline|Placebo|QHS dosing with placebo
1230255|NCT00156533|P4|Participant Flow|CTRL|Monitor only condition.
1230256|NCT00156533|P3|Participant Flow|Intermittant Zolpidem|Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed
1230257|NCT00156533|P2|Participant Flow|QHS (Nightly) Zolpidem|Once nightly (QHS) dosing with 10mg of zolpidem
1230258|NCT00156533|P1|Participant Flow|Placebo|Once nightly dosing (quaque hora somni [QHS])with placebo
1230272|NCT00156390|B2|Baseline|LV Lead Placement as Per Standard of Care (Without Echo-guidan|"LV lead placement as per standard of care (without echo-guidance)~placement of the LV lead of the biventricular pacing device without echocardiographic guidance"
1230273|NCT00156390|B1|Baseline|Echo-guided LV Lead Placement|"echo-guided LV lead placement~echo-guided left ventricular lead placement: placement of the LV lead of the biventricular pacing device under echocardiographic guidance"
1230274|NCT00156390|P2|Participant Flow|LV Lead Placement as Per Standard of Care (Without Echo-guida|"LV lead placement as per standard of care (without echo-guidance)~placement of the LV lead of the biventricular pacing device without echocardiographic guidance"
1230275|NCT00156390|P1|Participant Flow|Echo-guided LV Lead Placement|"echo-guided LV lead placement~echo-guided left ventricular lead placement: placement of the LV lead of the biventricular pacing device under echocardiographic guidance"
1230276|NCT00156390|O2|Outcome|LV Lead Placement as Per Standard of Care (Without Echo-guidan|"LV lead placement as per standard of care (without echo-guidance)~placement of the LV lead of the biventricular pacing device without echocardiographic guidance"
1230277|NCT00156390|O1|Outcome|Echo-guided LV Lead Placement|"echo-guided LV lead placement~echo-guided left ventricular lead placement: placement of the LV lead of the biventricular pacing device under echocardiographic guidance"
1230278|NCT00156390|E2|Reported Event|LV Lead Placement as Per Standard of Care (Without Echo-guidan|"LV lead placement as per standard of care (without echo-guidance)~placement of the LV lead of the biventricular pacing device without echocardiographic guidance"
1230279|NCT00156390|E1|Reported Event|Echo-guided LV Lead Placement|"echo-guided LV lead placement~echo-guided left ventricular lead placement: placement of the LV lead of the biventricular pacing device under echocardiographic guidance"
1230280|NCT00156247|B1|Baseline|Etanercept With Acitretin|patients on etanercept taking open-label acitretin
1230281|NCT00156247|P1|Participant Flow|Etanercept With Acitretin|patients on etanercept taking open-label acitretin
1230282|NCT00156247|O1|Outcome|Etanercept With Acitretin|patients on etanercept taking open-label acitretin
1230283|NCT00156247|O1|Outcome|Etanercept With Acitretin|patients on etanercept taking open-label acitretin
1230284|NCT00156247|O1|Outcome|Etanercept With Acitretin|patients on etanercept taking open-label acitretin
1230285|NCT00156247|E1|Reported Event|Etanercept With Acitretin|patients on etanercept taking open-label acitretin
1230286|NCT00156065|B4|Baseline|Total|Total of all reporting groups
1230287|NCT00156065|B3|Baseline|Haloperidol/Haloperidol|Haloperidol 2-8 mg BID in Original Study and in Current Long-Term Extension
1230288|NCT00156065|B2|Baseline|Asenapine/Asenapine|Asenapine 5 or 10 mg BID in Original Study and in Current Long-Term Extension
1230289|NCT00156065|B1|Baseline|Placebo/Asenapine|Placebo in Original Study (NCT00156104) and Asenapine 5 or 10 mg BID (twice daily) in Current Long-Term Extension
1230290|NCT00156065|P3|Participant Flow|Haloperidol/Haloperidol|Haloperidol 2-8 mg BID in Original Study and in Current Long-Term Extension
1230291|NCT00156065|P2|Participant Flow|Asenapine/Asenapine|Asenapine 5 or 10 mg BID in Original Study and in Current Long-Term Extension
1230292|NCT00156065|P1|Participant Flow|Placebo/Asenapine|Placebo in Original Study (NCT00156104) and Asenapine 5 or 10 mg BID (twice daily) in Current Long-Term Extension
1230293|NCT00156065|O3|Outcome|Haloperidol/Haloperidol|Haloperidol 2-8 mg BID in Original Study and in Current Long-Term Extension
1230294|NCT00156065|O2|Outcome|Asenapine/Asenapine|Asenapine 5 or 10 mg BID in Original Study and in Current Long-Term Extension
1230295|NCT00156065|O1|Outcome|Placebo/Asenapine|Placebo in Original Study (NCT00156104) and Asenapine 5 or 10 mg BID (twice daily) in Current Long-Term Extension
1230296|NCT00156065|O3|Outcome|Haloperidol/Haloperidol|Haloperidol 2-8 mg BID in Original Study and in Current Long-Term Extension
1230297|NCT00156065|O2|Outcome|Asenapine/Asenapine|Asenapine 5 or 10 mg BID in Original Study and in Current Long-Term Extension
1230298|NCT00156065|O1|Outcome|Placebo/Asenapine|Placebo in Original Study (NCT00156104) and Asenapine 5 or 10 mg BID (twice daily) in Current Long-Term Extension
1230299|NCT00156065|E3|Reported Event|Haloperidol/Haloperidol|Haloperidol 2-8 mg BID in Original Study and in Current Long-Term Extension
1230300|NCT00156065|E2|Reported Event|Asenapine/Asenapine|Asenapine 5 or 10 mg BID in Original Study and in Current Long-Term Extension
1230301|NCT00156065|E1|Reported Event|Placebo/Asenapine|Placebo in Original Study (NCT00156104) and Asenapine 5 or 10 mg BID (twice daily) in Current Long-Term Extension
1230302|NCT00156013|B1|Baseline|Clofarabine|Clofarabine 4 mg/m^2 days 1-5 of every cycle for a maximum of 6 cycles.
1230303|NCT00156013|P1|Participant Flow|Clofarabine|Clofarabine 4 mg/m^2 days 1-5 of every cycle for a maximum of 6 cycles.
1230304|NCT00156013|O1|Outcome|Clofarabine|During the Phase I part of the study, the starting dose of clofarabine will be 4 mg/m2 administered by IVI over 1 hour for 5 consecutive days and repeated every 28 days until disease progression is observed or for a maximum of 6 cycles. Cohorts of 3 patients each will receive doses of clofarabine increased in increments of 2mg/m2. The MTD was 6mg/m2. The dose level immediately below the MTD (4mg/m2) will be used to treat patients in the Phase II part of the study.
1230305|NCT00156013|E1|Reported Event|Clofarabine|Clofarabine 4 mg/m^2 days 1-5 of every cycle for a maximum of 6 cycles.
1230306|NCT00154466|B4|Baseline|Total|Total of all reporting groups
1230307|NCT00154466|B3|Baseline|Healthy Controls|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
1230308|NCT00154466|B2|Baseline|Postinfarction Nontraining Patients|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
1230309|NCT00154466|B1|Baseline|Postinfarction Training Patients|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
1230310|NCT00154466|P3|Participant Flow|Healthy Controls|For comparison of myocardial perfusion and angiogenic cytokines, 19 age-, weight-, and height-matched subjects without cardiovascular risk factors were selected as healthy controls.
1230311|NCT00154466|P2|Participant Flow|Post-infarction Nontraining|in which patients continued their usual lifestyle.
1230312|NCT00154466|P1|Participant Flow|Post-infarction Training|which underwent a 3-month cardiac rehabilitation program
1230313|NCT00154466|O3|Outcome|Healthy Controls|19 age- and sex-matched healthy volunteers
1230314|NCT00154466|O2|Outcome|Post-infarction Nontraining|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
1230315|NCT00154466|O1|Outcome|Post-infarction Training|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
1230316|NCT00154466|O2|Outcome|Post-infarction Nontraining|Eligible patients who provided written informed consent were randomly assigned to the training group, which underwent a 3-month cardiac rehabilitation program, or the nontraining group in which patients continued their usual lifestyle. At baseline and the 3-month follow-up, all patients underwent a functional evaluation that included clinical evaluation, exercise testing, cardiac magnetic resonance imaging (MRI), and measurements of plasma angiogenic cytokines levels. Both groups were receiving stable and optimal pharmacologic treatment supervised by their physicians.
1230317|NCT00154466|O1|Outcome|Post-infarction Training|Eligible patients who provided written informed consent were randomly assigned to the training group, which underwent a 3-month cardiac rehabilitation program, or the nontraining group in which patients continued their usual lifestyle. At baseline and the 3-month follow-up, all patients underwent a functional evaluation that included clinical evaluation, exercise testing, cardiac magnetic resonance imaging (MRI), and measurements of plasma angiogenic cytokines levels. Both groups were receiving stable and optimal pharmacologic treatment supervised by their physicians.
1230318|NCT00154466|E3|Reported Event|Healthy Controls|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
1230319|NCT00154466|E2|Reported Event|Postinfarction Nontraining Patients|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
1230320|NCT00154466|E1|Reported Event|Postinfarction Training Patients|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
1230321|NCT00154375|B3|Baseline|Total|Total of all reporting groups
1230322|NCT00154375|B2|Baseline|Hydroxyurea Alone|1500 mg/day of HU given as 500 mg 3 times daily. Every 6 weeks after randomization and based on assessment of therapeutic response, the patients were either switched to combination arm or continued in monotherapy arm of hydroxyurea.
1230323|NCT00154375|B1|Baseline|Imatinib Mesylate + Hydroxyurea (HU)|Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Every 6 weeks after randomization based on assessment of therapeutic response, either patients continued with above mentioned dosing regimen or switched to receive a daily dose of 800 mg imatinib with 1000 mg HU. Patients were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening.
1230324|NCT00154375|P2|Participant Flow|Hydroxyurea Alone|1500 mg/day of HU given as 500 mg 3 times daily. Every 6 weeks after randomization and based on assessment of therapeutic response, the patients were either switched to combination arm or continued in monotherapy arm of hydroxyurea.
1230325|NCT00154375|P1|Participant Flow|Imatinib Mesylate + Hydroxyurea (HU)|Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Every 6 weeks after randomization based on assessment of therapeutic response, either patients continued with above mentioned dosing regimen or switched to receive a daily dose of 800 mg imatinib with 1000 mg HU. Patients were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening.
1230326|NCT00154375|O2|Outcome|Hydroxyurea Alone|1500 mg/day of HU given as 500 mg 3 times daily. Every 6 weeks after randomization and based on assessment of therapeutic response, the patients were either switched to combination arm or continued in monotherapy arm of hydroxyurea.
1230327|NCT00154375|O1|Outcome|Imatinib Mesylate + Hydroxyurea (HU)|Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Every 6 weeks after randomization based on assessment of therapeutic response, either patients continued with above mentioned dosing regimen or switched to receive a daily dose of 800 mg imatinib with 1000 mg HU. Patients were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening.
1230328|NCT00154375|O2|Outcome|Hydroxyurea Alone|1500 mg/day of HU given as 500 mg 3 times daily. Every 6 weeks after randomization and based on assessment of therapeutic response, the patients were either switched to combination arm or continued in monotherapy arm of hydroxyurea.
1230329|NCT00154375|O1|Outcome|Imatinib Mesylate + Hydroxyurea (HU)|Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Every 6 weeks after randomization based on assessment of therapeutic response, either patients continued with above mentioned dosing regimen or switched to receive a daily dose of 800 mg imatinib with 1000 mg HU. Patients were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening.
1230330|NCT00154375|E3|Reported Event|Period After Switch to Combination|After every 6 weeks from randomization, depending on the assessment of therapeutic effect, patients were switched from Hydroxyurea (1500 mg/day p.o) to combination arm where patients were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time).
1230331|NCT00154375|E2|Reported Event|Period With Hydroxyurea Alone|1500 mg/day of HU given as 500 mg 3 times daily.
1230332|NCT00154375|E1|Reported Event|Imatinib Mesylate + Hydroxyurea (HU)|Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Patients receiving a daily dose of 800 mg imatinib with 1000 mg HU were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening.
1230333|NCT00154310|B3|Baseline|Total|Total of all reporting groups
1230705|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
1230334|NCT00154310|B2|Baseline|Cyclosporine + Mycophenolate Sodium|Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
1230335|NCT00154310|B1|Baseline|Everolimus + Mycophenolate Sodium|Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
1230336|NCT00154310|P2|Participant Flow|Cyclosporine + Mycophenolate Sodium|Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
1230337|NCT00154310|P1|Participant Flow|Everolimus + Mycophenolate Sodium|Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
1230338|NCT00154310|O2|Outcome|Cyclosporine + Mycophenolate Sodium|Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
1230339|NCT00154310|O1|Outcome|Everolimus + Mycophenolate Sodium|Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
1230340|NCT00154310|O2|Outcome|Cyclosporine + Mycophenolate Sodium|Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
1230341|NCT00154310|O1|Outcome|Everolimus + Mycophenolate Sodium|Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
1230342|NCT00154310|O2|Outcome|Cyclosporine + Mycophenolate Sodium|Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
1230343|NCT00154310|O1|Outcome|Everolimus + Mycophenolate Sodium|Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
1230344|NCT00154310|O2|Outcome|Cyclosporine + Mycophenolate Sodium|Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
1230345|NCT00154310|O1|Outcome|Everolimus + Mycophenolate Sodium|Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
1230346|NCT00154310|O2|Outcome|Cyclosporine + Mycophenolate Sodium|Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
1230347|NCT00154310|O1|Outcome|Everolimus + Mycophenolate Sodium|Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
1230348|NCT00154310|E2|Reported Event|Sandimmun Optoral|Sandimmun Optoral
1230349|NCT00154310|E1|Reported Event|Certican|Certican
1230350|NCT00154297|B3|Baseline|Total|Total of all reporting groups
1230351|NCT00154297|B2|Baseline|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
1230352|NCT00154297|B1|Baseline|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
1230353|NCT00154297|P2|Participant Flow|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
1230560|NCT00153101|B2|Baseline|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
1230354|NCT00154297|P1|Participant Flow|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
1230355|NCT00154297|O2|Outcome|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
1230356|NCT00154297|O1|Outcome|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
1230357|NCT00154297|O2|Outcome|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
1230358|NCT00154297|O1|Outcome|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
1230359|NCT00154297|O2|Outcome|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
1230360|NCT00154297|O1|Outcome|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
1230361|NCT00154297|O2|Outcome|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
1230362|NCT00154297|O1|Outcome|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
1230363|NCT00154297|O2|Outcome|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
1230364|NCT00154297|O1|Outcome|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
1230365|NCT00154297|O2|Outcome|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
1230366|NCT00154297|O1|Outcome|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
1230367|NCT00154297|E2|Reported Event|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
1230368|NCT00154297|E1|Reported Event|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
1230369|NCT00154284|B3|Baseline|Total|Total of all reporting groups
1230370|NCT00154284|B2|Baseline|Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
1230371|NCT00154284|B1|Baseline|Everolimus (Certican) With Cyclosporine (Neoral) Continuation|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
1230372|NCT00154284|P2|Participant Flow|Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
1230373|NCT00154284|P1|Participant Flow|Everolimus (Certican) With Cyclosporine (Neoral) Continuation|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
1230374|NCT00154284|O2|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Continuation|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
1230375|NCT00154284|O1|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
1230376|NCT00154284|O2|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Continuation|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
1230377|NCT00154284|O1|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
1230378|NCT00154284|O2|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
1230379|NCT00154284|O1|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Continuation|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
1230380|NCT00154284|O2|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
1230381|NCT00154284|O1|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Continuation|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
1230382|NCT00154284|E2|Reported Event|Everolimus (Certican) With Cyclosporine (Neoral) Continuation|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
1230383|NCT00154284|E1|Reported Event|Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
1230384|NCT00154102|B3|Baseline|Total|Total of all reporting groups
1230561|NCT00153101|B1|Baseline|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
1230385|NCT00154102|B2|Baseline|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230386|NCT00154102|B1|Baseline|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230387|NCT00154102|P2|Participant Flow|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230388|NCT00154102|P1|Participant Flow|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230389|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230390|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230391|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230392|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230393|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230394|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230395|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230396|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230397|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230398|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230399|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230400|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230401|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230402|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230403|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230424|NCT00154063|P2|Participant Flow|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230404|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230405|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230406|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230407|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230408|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230409|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230410|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230411|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230412|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230413|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230414|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230415|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230416|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230417|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230418|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
1230419|NCT00154102|E2|Reported Event|FOLFIRI Alone|"Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops.~Safety population: includes all treated subjects"
1230420|NCT00154102|E1|Reported Event|Cetuximab Plus FOLFIRI|"Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops.~Safety population: includes all treated subjects."
1230421|NCT00154063|B3|Baseline|Total|Total of all reporting groups
1230422|NCT00154063|B2|Baseline|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230423|NCT00154063|B1|Baseline|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230697|NCT00152971|P2|Participant Flow|Dabigatran 150mg|qd (once daily) oral
1230425|NCT00154063|P1|Participant Flow|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230426|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230427|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230428|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230429|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230430|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230431|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230432|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230433|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230434|NCT00154063|O2|Outcome|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230435|NCT00154063|O1|Outcome|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230436|NCT00154063|O2|Outcome|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230437|NCT00154063|O1|Outcome|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230438|NCT00154063|O2|Outcome|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230439|NCT00154063|O1|Outcome|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230440|NCT00154063|O2|Outcome|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230441|NCT00154063|O1|Outcome|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230442|NCT00154063|O2|Outcome|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230443|NCT00154063|O1|Outcome|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230444|NCT00154063|O2|Outcome|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230445|NCT00154063|O1|Outcome|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230446|NCT00154063|O2|Outcome|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230518|NCT00153816|O2|Outcome|Full Factorial Calcium|"subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
1230447|NCT00154063|O1|Outcome|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230448|NCT00154063|O2|Outcome|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230449|NCT00154063|O1|Outcome|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230450|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230451|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230452|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230453|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230454|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230455|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230456|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230457|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230458|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230459|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230460|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230461|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230462|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230463|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230464|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230465|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230466|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230467|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230468|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230519|NCT00153816|O1|Outcome|Full Factorial Placebo|"subjects in 2X2 factorial design; randomized to daily placebo~placebo: placebo; two tablets per day"
1230469|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230470|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230471|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230472|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230473|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230474|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230475|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230476|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230477|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230478|NCT00154063|E2|Reported Event|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230479|NCT00154063|E1|Reported Event|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
1230480|NCT00153985|B1|Baseline|Transplant for Severe Hemoglobinopathies|Patients with severe hemoglobinopathies (eg. sickle cell disease, thalassemia major) with related donors who are identical at 6 HLA loci: (HLA-A, HLA-B, HLA-DRB1). The preparative regimen consisted of Busulfex, fludarabine and alemtuzumab.
1230481|NCT00153985|P1|Participant Flow|Transplant for Severe Hemoglobinopathies|Patients with severe hemoglobinopathies (eg. sickle cell disease, thalassemia major) with related donors who are identical at 6 HLA loci: (HLA-A, HLA-B, HLA-DRB1). The preparative regimen consisted of Busulfex, fludarabine and alemtuzumab.
1230482|NCT00153985|O1|Outcome|Transplant for Severe Hemoglobinopathies|Patients with severe hemoglobinopathies (eg. sickle cell disease, thalassemia major) with related donors who are identical at 6 HLA loci: (HLA-A, HLA-B, HLA-DRB1). The preparative regimen consisted of Busulfex, fludarabine and alemtuzumab.
1230483|NCT00153985|O1|Outcome|Transplant for Severe Hemoglobinopathies|Patients with severe hemoglobinopathies (eg. sickle cell disease, thalassemia major) with related donors who are identical at 6 HLA loci: (HLA-A, HLA-B, HLA-DRB1). The preparative regimen consisted of Busulfex, fludarabine and alemtuzumab.
1230484|NCT00153985|O1|Outcome|Transplant for Severe Hemoglobinopathies|Patients with severe hemoglobinopathies (eg. sickle cell disease, thalassemia major) with related donors who are identical at 6 HLA loci: (HLA-A, HLA-B, HLA-DRB1). The preparative regimen consisted of Busulfex, fludarabine and alemtuzumab.
1230485|NCT00153985|E1|Reported Event|Transplant for Severe Hemoglobinopathies|Patients with severe hemoglobinopathies (eg. sickle cell disease, thalassemia major) with related donors who are identical at 6 HLA loci: (HLA-A, HLA-B, HLA-DRB1). The preparative regimen consisted of Busulfex, fludarabine and alemtuzumab.
1230486|NCT00153920|B1|Baseline|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
1230487|NCT00153920|P1|Participant Flow|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
1230488|NCT00153920|O1|Outcome|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
1230489|NCT00153920|O1|Outcome|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
1230490|NCT00153920|O1|Outcome|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
1230559|NCT00153101|B3|Baseline|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
1230706|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
1230491|NCT00153920|O1|Outcome|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
1230492|NCT00153920|O1|Outcome|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
1230493|NCT00153920|O1|Outcome|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
1230494|NCT00153920|E1|Reported Event|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
1230495|NCT00153816|B7|Baseline|Total|Total of all reporting groups
1230496|NCT00153816|B6|Baseline|Two Arm Vitamin D|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
1230497|NCT00153816|B5|Baseline|Two Arm Placebo|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
1230498|NCT00153816|B4|Baseline|Full Factorial Calcium Plus Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
1230499|NCT00153816|B3|Baseline|Full Factorial Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
1230500|NCT00153816|B2|Baseline|Full Factorial Calcium|"subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
1230501|NCT00153816|B1|Baseline|Full Factorial Placebo|"subjects in 2X2 factorial design; randomized to daily placebo~placebo: placebo; two tablets per day"
1230502|NCT00153816|P6|Participant Flow|Two Arm Vitamin D|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
1230503|NCT00153816|P5|Participant Flow|Two Arm Placebo|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
1230504|NCT00153816|P4|Participant Flow|Full Factorial Calcium Plus Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
1230505|NCT00153816|P3|Participant Flow|Full Factorial Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
1230506|NCT00153816|P2|Participant Flow|Full Factorial Calcium|"subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
1230507|NCT00153816|P1|Participant Flow|Full Factorial Placebo|"subjects in 2X2 factorial design; randomized to daily placebo~placebo: placebo; two tablets per day"
1230508|NCT00153816|O6|Outcome|Two Arm Vitamin D|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
1230509|NCT00153816|O5|Outcome|Two Arm Placebo|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
1230510|NCT00153816|O4|Outcome|Full Factorial Calcium Plus Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
1230511|NCT00153816|O3|Outcome|Full Factorial Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
1230512|NCT00153816|O2|Outcome|Full Factorial Calcium|"subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
1230513|NCT00153816|O1|Outcome|Full Factorial Placebo|"subjects in 2X2 factorial design; randomized to daily placebo~placebo: placebo; two tablets per day"
1230514|NCT00153816|O6|Outcome|Two Arm Vitamin D|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
1230515|NCT00153816|O5|Outcome|Two Arm Placebo|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
1230516|NCT00153816|O4|Outcome|Full Factorial Calcium Plus Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
1230517|NCT00153816|O3|Outcome|Full Factorial Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
1230698|NCT00152971|P1|Participant Flow|Dabigatran 220mg|qd (once daily) oral
1230520|NCT00153816|E6|Reported Event|Two Arm Vitamin D|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
1230521|NCT00153816|E5|Reported Event|Two Arm Placebo|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
1230522|NCT00153816|E4|Reported Event|Full Factorial Calcium Plus Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
1230523|NCT00153816|E3|Reported Event|Full Factorial Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
1230524|NCT00153816|E2|Reported Event|Full Factorial Calcium|"subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
1230525|NCT00153816|E1|Reported Event|Full Factorial Placebo|"subjects in 2X2 factorial design; randomized to daily placebo~placebo: placebo; two tablets per day"
1230526|NCT00153179|B3|Baseline|Total|Total of all reporting groups
1230527|NCT00153179|B2|Baseline|Metabolic Syndrome|
1230528|NCT00153179|B1|Baseline|Healthy Controls|
1230529|NCT00153179|P4|Participant Flow|Metabolic Syndrome, Acipimox First, Then Placebo|The study is a randomized, placebo-controlled, double-blind, cross-over trial in subjects with the metabolic syndrome and healthy subjects with interventions assessed over one day of treatment and a washout period of 4 weeks. Acipimox (Pharmacia and Upjohn (Pfizer), Kalamazoo, MI), 250 mg, or matching placebo will be given at 7 PM, 1 AM, and 7 AM, and 11 AM prior to and on the day of study.
1230530|NCT00153179|P3|Participant Flow|Metabolic Syndrome, Placebo First, Then Acipimox|The study is a randomized, placebo-controlled, double-blind, cross-over trial in subjects with the metabolic syndrome and healthy subjects with interventions assessed over one day of treatment and a washout period of 4 weeks. Acipimox (Pharmacia and Upjohn (Pfizer), Kalamazoo, MI), 250 mg, or matching placebo will be given at 7 PM, 1 AM, and 7 AM, and 11 AM prior to and on the day of study.
1230531|NCT00153179|P2|Participant Flow|Healthy Controls, Acipimox First, Then Placebo|The study is a randomized, placebo-controlled, double-blind, cross-over trial in subjects with the metabolic syndrome and healthy subjects with interventions assessed over one day of treatment and a washout period of 4 weeks. Acipimox (Pharmacia and Upjohn (Pfizer), Kalamazoo, MI), 250 mg, or matching placebo will be given at 7 PM, 1 AM, and 7 AM, and 11 AM prior to and on the day of study.
1230532|NCT00153179|P1|Participant Flow|Healthy Controls, Placebo First, Then Acipimox|The study is a randomized, placebo-controlled, double-blind, cross-over trial in subjects with the metabolic syndrome and healthy subjects with interventions assessed over one day of treatment and a washout period of 4 weeks. Acipimox (Pharmacia and Upjohn (Pfizer), Kalamazoo, MI), 250 mg, or matching placebo will be given at 7 PM, 1 AM, and 7 AM, and 11 AM prior to and on the day of study.
1230533|NCT00153179|O4|Outcome|Metabolic Syndrome, Acipimox Treatment|
1230534|NCT00153179|O3|Outcome|Metabolic Syndrome, Placebo Treatment|
1230535|NCT00153179|O2|Outcome|Healthy Controls, Acipimox Treatment|
1230536|NCT00153179|O1|Outcome|Healthy Controls, Placebo Treatment|
1230537|NCT00153179|E2|Reported Event|Metabolic Syndrome|
1230538|NCT00153179|E1|Reported Event|Healthy Controls|
1230539|NCT00153166|B4|Baseline|Total|Total of all reporting groups
1230540|NCT00153166|B3|Baseline|PAD Without Diabetes|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less. These patients do not have diabetes.
1230541|NCT00153166|B2|Baseline|Patients With PAD|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less.
1230542|NCT00153166|B1|Baseline|Healthy Controls|Healthy individuals, non-smokers, normal CV examination.
1230543|NCT00153166|P3|Participant Flow|PAD (Excluding Patients With Diabetes)|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less. Excluding those patients with diabetes. Randomized to atorvastatin/pioglitazone, atorvastatin/placebo, placebo/pioglitazone, or placebo/placebo.
1230544|NCT00153166|P2|Participant Flow|Patients With PAD|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less. Randomized to atorvastatin/pioglitazone, atorvastatin/placebo, placebo/pioglitazone, or placebo/placebo.
1230545|NCT00153166|P1|Participant Flow|Healthy Controls|Healthy individuals, non-smokers, normal CV examination. Randomized to atorvastatin/pioglitazone, atorvastatin/placebo, placebo/pioglitazone, or placebo/placebo.
1230546|NCT00153166|O3|Outcome|PAD (Excluding Diabetes)|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less. These patients do not have diabetes.
1230547|NCT00153166|O2|Outcome|Patients With PAD|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less.
1230548|NCT00153166|O1|Outcome|Healthy Controls|Healthy individuals, non-smokers, normal CV examination.
1230549|NCT00153166|O3|Outcome|PAD (Excluding Diabetes)|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less. These patients do not have diabetes.
1230550|NCT00153166|O2|Outcome|Patients With PAD|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less.
1230551|NCT00153166|O1|Outcome|Healthy Controls|Healthy individuals, non-smokers, normal CV examination.
1230552|NCT00153166|E4|Reported Event|Received Placebo/Placebo|Including healthy subjects and subjects with PAD
1230553|NCT00153166|E3|Reported Event|Received Placebo/Pioglitazone|Including healthy subjects and subjects with PAD
1230554|NCT00153166|E2|Reported Event|Received Atorvastatin/Placebo|Including healthy subjects and subjects with PAD
1230555|NCT00153166|E1|Reported Event|Received Atorvastatin/Pioglitazone|Including healthy subjects and subjects with PAD
1230556|NCT00153101|B6|Baseline|Total|Total of all reporting groups
1230557|NCT00153101|B5|Baseline|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
1230558|NCT00153101|B4|Baseline|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
1230562|NCT00153101|P5|Participant Flow|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
1230563|NCT00153101|P4|Participant Flow|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
1230564|NCT00153101|P3|Participant Flow|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
1230565|NCT00153101|P2|Participant Flow|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
1230566|NCT00153101|P1|Participant Flow|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
1230567|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
1230568|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
1230569|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
1230570|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
1230571|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
1230572|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
1230573|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
1230574|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
1230575|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
1230576|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
1230577|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
1230578|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
1230579|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
1230580|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
1230581|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
1230582|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
1230583|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
1230584|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
1230585|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
1230586|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
1230587|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
1230588|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
1230589|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
1230590|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
1230591|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
1230592|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
1230593|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
1230594|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
1230595|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
1230596|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
1230597|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
1230598|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
1230599|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
1230600|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
1230601|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
1230602|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
1230603|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
1230604|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
1230605|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
1230606|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
1230607|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
1230608|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
1230609|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
1230610|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
1230611|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
1230612|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
1230613|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
1230614|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
1230615|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
1230616|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
1230617|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
1230618|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
1230619|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
1230620|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
1230621|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
1230622|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
1230623|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
1230624|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
1230625|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
1230626|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
1230627|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
1230628|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
1230629|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
1230630|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
1230631|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
1230632|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
1230633|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
1230634|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
1230635|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
1230636|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
1230637|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
1230638|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
1230639|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
1230640|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
1230641|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
1230642|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
1230643|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
1230644|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
1230645|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
1230646|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
1230647|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
1230648|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
1230649|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
1230650|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
1230699|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
1230651|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
1230652|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
1230653|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
1230654|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
1230655|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
1230656|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
1230657|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
1230658|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
1230659|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
1230660|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
1230661|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
1230662|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
1230663|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
1230664|NCT00153101|E5|Reported Event|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
1230665|NCT00153101|E4|Reported Event|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
1230666|NCT00153101|E3|Reported Event|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
1230667|NCT00153101|E2|Reported Event|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
1230668|NCT00153101|E1|Reported Event|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
1230669|NCT00153062|B5|Baseline|Total|Total of all reporting groups
1230670|NCT00153062|B4|Baseline|Clopidogrel / Placebo|clopidogrel 75 mg, once daily, tablet / placebo tablet
1230671|NCT00153062|B3|Baseline|Clopidogrel / Telmisartan|clopidogrel 75 mg, once daily, tablet / telmisartan 80 mg, once daily, tablet
1230672|NCT00153062|B2|Baseline|Aspirin + Extended Release Dipyridamole / Placebo|25 mg aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / placebo tablet
1230673|NCT00153062|B1|Baseline|Aspirin + Extended Release Dipyridamole / Telmisartan|25 milligrams (mg) aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / telmisartan 80 mg, once daily, tablet
1230674|NCT00153062|P4|Participant Flow|Clopidogrel / Placebo|clopidogrel 75 mg, once daily, tablet / placebo tablet
1230675|NCT00153062|P3|Participant Flow|Clopidogrel / Telmisartan|clopidogrel 75 mg, once daily, tablet / telmisartan 80 mg, once daily, tablet
1230676|NCT00153062|P2|Participant Flow|Aspirin + Extended Release Dipyridamole / Placebo|25 mg aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / placebo tablet
1230677|NCT00153062|P1|Participant Flow|Aspirin + Extended Release Dipyridamole / Telmisartan|25 milligrams (mg) aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / telmisartan 80 mg, once daily, tablet
1230678|NCT00153062|O2|Outcome|Placebo|Consists of patients in the two treatment groups: ASA+ERDP + placebo and Clopidogrel + placebo
1230679|NCT00153062|O1|Outcome|Telmisartan|Consists of patients in the two treatment groups: ASA+ERDP + telmisartan and Clopidogrel + telmisartan
1230680|NCT00153062|O2|Outcome|Placebo|Consists of patients in the two treatment groups: ASA+ERDP + placebo and Clopidogrel + placebo
1230681|NCT00153062|O1|Outcome|Telmisartan|Consists of patients in the two treatment groups: ASA+ERDP + telmisartan and Clopidogrel + telmisartan
1230682|NCT00153062|O2|Outcome|Placebo|Consists of patients in the two treatment groups: ASA+ERDP + placebo and Clopidogrel + placebo
1230683|NCT00153062|O1|Outcome|Telmisartan|Consists of patients in the two treatment groups: ASA+ERDP + telmisartan and Clopidogrel + telmisartan
1230684|NCT00153062|O2|Outcome|Clopidogrel|Consists of patients in the two treatment groups: Clopidogrel + telmisartan and Clopidogrel + placebo
1230685|NCT00153062|O1|Outcome|Aspirin + Extended Release Dipyridamole|Consists of patients in the two treatment groups: ASA+ERDP + telmisartan and ASA+ERDP + placebo
1230686|NCT00153062|O2|Outcome|Clopidogrel|Consists of patients in the two treatment groups: Clopidogrel + telmisartan and Clopidogrel + placebo
1230687|NCT00153062|O1|Outcome|Aspirin + Extended Release Dipyridamole|Consists of patients in the two treatment groups: ASA+ERDP + telmisartan and ASA+ERDP + placebo
1230688|NCT00153062|E4|Reported Event|Clopidogrel / Placebo|clopidogrel 75 mg, once daily, tablet / placebo tablet
1230689|NCT00153062|E3|Reported Event|Clopidogrel / Telmisartan|clopidogrel 75 mg, once daily, tablet / telmisartan 80 mg, once daily, tablet
1230690|NCT00153062|E2|Reported Event|Aspirin + Extended Release Dipyridamole / Placebo|25 mg aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / placebo tablet
1230691|NCT00153062|E1|Reported Event|Aspirin + Extended Release Dipyridamole / Telmisartan|25 milligrams (mg) aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / telmisartan 80 mg, once daily, tablet
1230692|NCT00152971|B4|Baseline|Total|Total of all reporting groups
1230693|NCT00152971|B3|Baseline|Enoxaparin|30mg bid (twice daily) subcutaneous
1230694|NCT00152971|B2|Baseline|Dabigatran 150mg|qd (once daily) oral
1230695|NCT00152971|B1|Baseline|Dabigatran 220mg|qd (once daily) oral
1230696|NCT00152971|P3|Participant Flow|Enoxaparin|30mg bid (twice daily) subcutaneous
1230711|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
1230712|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
1230713|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
1230714|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
1230715|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
1230716|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
1230717|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
1230718|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
1230719|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
1230720|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
1230721|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
1230722|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
1230723|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
1230724|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
1230725|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
1230726|NCT00152971|E3|Reported Event|Enoxaparin|30mg bid (twice daily) subcutaneous
1230727|NCT00152971|E2|Reported Event|Dabigatran 150mg|qd (once daily) oral
1230728|NCT00152971|E1|Reported Event|Dabigatran 220mg|qd (once daily) oral
1230729|NCT00152763|B5|Baseline|Total|Total of all reporting groups
1230730|NCT00152763|B4|Baseline|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
1230731|NCT00152763|B3|Baseline|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230732|NCT00152763|B2|Baseline|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
1230733|NCT00152763|B1|Baseline|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230734|NCT00152763|P4|Participant Flow|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
1230735|NCT00152763|P3|Participant Flow|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230736|NCT00152763|P2|Participant Flow|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
1230737|NCT00152763|P1|Participant Flow|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230738|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet. These data are on men and women combined within CBT.
1230739|NCT00152763|O1|Outcome|Usual Cardiac Care|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed. This includes all men and women who received UCC.
1230740|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
1230741|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230742|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
1230743|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1231188|NCT00150618|E4|Reported Event|SPD503 (4 mg)|Guanfacine HCl once daily
1230744|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
1231198|NCT00150592|O1|Outcome|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
1230745|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230746|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
1230747|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230748|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
1230749|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230750|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
1230751|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230752|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
1230753|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230754|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
1230755|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230756|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
1230757|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230758|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
1230759|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230760|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
1230761|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230762|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
1230763|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230764|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
1231196|NCT00150592|P1|Participant Flow|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
1230765|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230766|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
1230767|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230768|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
1230769|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230770|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
1230771|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230772|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
1230773|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230774|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
1230775|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230776|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
1230777|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230778|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
1230779|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230780|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
1230781|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230782|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
1230783|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230784|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
1231189|NCT00150618|E3|Reported Event|SPD503 (3 mg)|Guanfacine HCl once daily
1242809|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
1230785|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230786|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
1230787|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230788|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
1230789|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230790|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
1230791|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230792|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
1230793|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230794|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
1230795|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230796|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
1230797|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230798|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
1230799|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230800|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
1230801|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230802|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
1230803|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230804|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
1231190|NCT00150618|E2|Reported Event|SPD503 (2 mg)|Guanfacine HCl once daily
1242889|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
1230805|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230806|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
1230807|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230808|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
1230809|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230810|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
1230811|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230812|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
1230813|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230814|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
1230815|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230816|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
1230817|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230818|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
1230819|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230820|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
1230821|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230822|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
1230823|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230824|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
1231191|NCT00150618|E1|Reported Event|SPD503 (1 mg)|Guanfacine HCl once daily
1231192|NCT00150592|B3|Baseline|Total|Total of all reporting groups
1230825|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230826|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
1230827|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230828|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
1230829|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230830|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
1230831|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230832|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
1230833|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230834|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
1230835|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230836|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
1230837|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230838|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
1230839|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230840|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
1230841|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230842|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
1230843|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230844|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
1231193|NCT00150592|B2|Baseline|Placebo|
1231807|NCT00147745|B3|Baseline|Open-label Insulin Glargine|open-label Insulin Glargine for 12 weeks
1230845|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230846|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
1230847|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230848|NCT00152763|E4|Reported Event|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
1230849|NCT00152763|E3|Reported Event|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230850|NCT00152763|E2|Reported Event|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
1230851|NCT00152763|E1|Reported Event|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
1230852|NCT00152516|B1|Baseline|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
1230853|NCT00152516|P1|Participant Flow|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
1230854|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
1230855|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
1230856|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
1230857|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
1230858|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
1230859|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
1230860|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
1230861|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
1230862|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
1230863|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
1230864|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
1230865|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
1230866|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
1230867|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
1230868|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
1230869|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
1230870|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
1230871|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
1230872|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
1230873|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
1230874|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
1230875|NCT00152516|E1|Reported Event|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
1230876|NCT00152009|B5|Baseline|Total|Total of all reporting groups
1230877|NCT00152009|B4|Baseline|Placebo|Subjects were randomized to receive Placebo once-daily.
1230878|NCT00152009|B3|Baseline|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
1230879|NCT00152009|B2|Baseline|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
1230880|NCT00152009|B1|Baseline|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
1230881|NCT00152009|P4|Participant Flow|Placebo|Subjects were randomized to receive Placebo once-daily.
1230882|NCT00152009|P3|Participant Flow|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
1230883|NCT00152009|P2|Participant Flow|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
1230884|NCT00152009|P1|Participant Flow|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
1230885|NCT00152009|O4|Outcome|Placebo|Subjects were randomized to receive Placebo once-daily.
1230886|NCT00152009|O3|Outcome|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
1230887|NCT00152009|O2|Outcome|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
1230888|NCT00152009|O1|Outcome|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
1230889|NCT00152009|O4|Outcome|Placebo|Subjects were randomized to receive Placebo once-daily.
1230890|NCT00152009|O3|Outcome|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
1230891|NCT00152009|O2|Outcome|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
1230892|NCT00152009|O1|Outcome|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
1230893|NCT00152009|O4|Outcome|Placebo|Subjects were randomized to receive Placebo once-daily.
1230894|NCT00152009|O3|Outcome|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
1230895|NCT00152009|O2|Outcome|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
1230896|NCT00152009|O1|Outcome|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
1230897|NCT00152009|O4|Outcome|Placebo|Subjects were randomized to receive Placebo once-daily.
1230898|NCT00152009|O3|Outcome|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
1230899|NCT00152009|O2|Outcome|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
1230900|NCT00152009|O1|Outcome|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
1230901|NCT00152009|O4|Outcome|Placebo|Subjects were randomized to receive Placebo once-daily.
1230902|NCT00152009|O3|Outcome|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
1230903|NCT00152009|O2|Outcome|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
1230904|NCT00152009|O1|Outcome|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
1230905|NCT00152009|O4|Outcome|Placebo|Subjects were randomized to receive Placebo once-daily.
1230906|NCT00152009|O3|Outcome|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
1230907|NCT00152009|O2|Outcome|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
1230908|NCT00152009|O1|Outcome|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
1230909|NCT00152009|E4|Reported Event|Placebo|Subjects were randomized to receive Placebo once-daily.
1230910|NCT00152009|E3|Reported Event|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
1230911|NCT00152009|E2|Reported Event|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
1230912|NCT00152009|E1|Reported Event|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
1230913|NCT00151996|B3|Baseline|Total|Total of all reporting groups
1230914|NCT00151996|B2|Baseline|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
1230915|NCT00151996|B1|Baseline|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
1230916|NCT00151996|P2|Participant Flow|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
1230917|NCT00151996|P1|Participant Flow|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
1231197|NCT00150592|O2|Outcome|Placebo|
1230918|NCT00151996|O2|Outcome|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
1230919|NCT00151996|O1|Outcome|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
1230920|NCT00151996|O2|Outcome|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
1230921|NCT00151996|O1|Outcome|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
1230922|NCT00151996|O2|Outcome|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
1230923|NCT00151996|O1|Outcome|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
1230924|NCT00151996|O2|Outcome|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
1230925|NCT00151996|O1|Outcome|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
1230926|NCT00151996|O2|Outcome|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
1230927|NCT00151996|O1|Outcome|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
1230928|NCT00151996|E2|Reported Event|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
1230929|NCT00151996|E1|Reported Event|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
1230930|NCT00151892|B3|Baseline|Total|Total of all reporting groups
1230931|NCT00151892|B2|Baseline|Asacol|1.6g/day administered 800 mg BID
1230932|NCT00151892|B1|Baseline|SPD476|2.4 g/day QD
1230933|NCT00151892|P2|Participant Flow|Asacol|1.6g/day administered 800 mg twice daily (BID)
1230934|NCT00151892|P1|Participant Flow|SPD476|2.4 g/day once daily (QD)
1230935|NCT00151892|O2|Outcome|Asacol|1.6g/day administered 800 mg BID
1230936|NCT00151892|O1|Outcome|SPD476|2.4 g/day QD
1230937|NCT00151892|O2|Outcome|Asacol|1.6g/day administered 800 mg BID
1230938|NCT00151892|O1|Outcome|SPD476|2.4 g/day QD
1230939|NCT00151892|O2|Outcome|Asacol|1.6g/day administered 800 mg BID
1230940|NCT00151892|O1|Outcome|SPD476|2.4 g/day QD
1230941|NCT00151892|O2|Outcome|Asacol|1.6g/day administered 800 mg BID
1230942|NCT00151892|O1|Outcome|SPD476|2.4 g/day QD
1230943|NCT00151892|O2|Outcome|Asacol|1.6g/day administered 800 mg BID
1230944|NCT00151892|O1|Outcome|SPD476|2.4 g/day QD
1230945|NCT00151892|E2|Reported Event|Asacol|1.6g/day administered 800 mg BID
1230946|NCT00151892|E1|Reported Event|SPD476|2.4 g/day QD
1230947|NCT00151814|B4|Baseline|Total|Total of all reporting groups
1230948|NCT00151814|B3|Baseline|Olmesartan Group - 13 to 16 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
1230949|NCT00151814|B2|Baseline|Olmesartan Group - 6 to 12 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
1230950|NCT00151814|B1|Baseline|Olmesartan Group - 2 to 5 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
1230951|NCT00151814|P3|Participant Flow|Olmesartan Group - 13 to 16 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
1230952|NCT00151814|P2|Participant Flow|Olmesartan Group - 6 to 12 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
1230953|NCT00151814|P1|Participant Flow|Olmesartan Group - 2 to 5 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
1230954|NCT00151814|O2|Outcome|13-16 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
1230955|NCT00151814|O1|Outcome|6-12 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
1231020|NCT00151775|E10|Reported Event|Cohort B: Period 3 OM High Dose Continued|The 20 mg or 40 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.
1230956|NCT00151814|O2|Outcome|13-16 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
1230957|NCT00151814|O1|Outcome|6-12 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
1230958|NCT00151814|O2|Outcome|13-16 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
1230959|NCT00151814|O1|Outcome|6-12 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
1230960|NCT00151814|O2|Outcome|13-16 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
1230961|NCT00151814|O1|Outcome|6-12 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
1230962|NCT00151814|O2|Outcome|13-16 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
1230963|NCT00151814|O1|Outcome|6-12 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
1230964|NCT00151814|O2|Outcome|13-16 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
1230965|NCT00151814|O1|Outcome|6-12 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
1230966|NCT00151814|O2|Outcome|13-16 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
1230967|NCT00151814|O1|Outcome|6-12 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
1230968|NCT00151814|O2|Outcome|13-16 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
1230969|NCT00151814|O1|Outcome|6-12 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
1230970|NCT00151814|E3|Reported Event|Olmesartan Group - 13 to 16 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
1230971|NCT00151814|E2|Reported Event|Olmesartan Group - 6 to 12 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
1230972|NCT00151814|E1|Reported Event|Olmesartan Group - 2 to 5 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
1230973|NCT00151775|B6|Baseline|Total|Total of all reporting groups
1230974|NCT00151775|B5|Baseline|Cohort C: OM (Olmesartan Medoxomil)|Cohort C (1-5 years old) was given olmesartan medoxomil (OM) 0.3 mg/kg in Period 2 (open-label period) and a subgroup of Cohort C was given that dose of OM during Period 3 (double-blind, placebo-controlled period). In Period 4 (open-label period), all of Cohort C received an OM starting dose of 0.3 mg/kg. If hypertension was not controlled after two week the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
1230975|NCT00151775|B4|Baseline|Cohort B: Low Dose OM|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
1230976|NCT00151775|B3|Baseline|Cohort B: High Dose OM|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
1230977|NCT00151775|B2|Baseline|Cohort A: Low Dose OM|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
1243738|NCT00110305|O1|Outcome|TMC278 25mg|TMC278 25 mg once daily
1230978|NCT00151775|B1|Baseline|Cohort A: High Dose OM|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
1230979|NCT00151775|P12|Participant Flow|Cohort C: Placebo in Period 3 (From OM in Period 2)|Subgroup of Cohort C (1-5 years old) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5).
1230980|NCT00151775|P11|Participant Flow|Cohort C: OM in Periods 2, 3, 4|Cohort C (1-5 years old) was given olmesartan medoxomil (OM) 0.3 mg/kg in Period 2 (open-label period from day 0 to week 3) and a subgroup of Cohort C was given that dose of OM during Period 3 (double-blind, placebo-controlled period from week 3 to week 5). In Period 4 (open-label period from weeks 6-51), all of Cohort C received an OM starting dose of 0.3 mg/kg. If hypertension was not controlled after two week the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
1230981|NCT00151775|P10|Participant Flow|Cohort B: Period 4 Open-label OM|All members of Cohort B (6-16 years old comprised exclusively of Black participants) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4 (weeks 6-51). Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
1230982|NCT00151775|P9|Participant Flow|Cohort B: Placebo in Period 3 (From Low Dose in Period 2)|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous low dose of olmesartan.
1230983|NCT00151775|P8|Participant Flow|Cohort B: Placebo in Period 3 (From High Dose in Period 2)|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous high dose of olmesartan.
1230984|NCT00151775|P7|Participant Flow|Cohort B: Low Dose OM in Periods 2, 3|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5).
1230985|NCT00151775|P6|Participant Flow|Cohort B: High Dose OM in Periods 2, 3|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5).
1230986|NCT00151775|P5|Participant Flow|Cohort A: Period 4 Open-label OM|All members of Cohort A (6-16 years old with a limit on the number of Black participants) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4 (weeks 6-51). Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
1230987|NCT00151775|P4|Participant Flow|Cohort A: Placebo in Period 3 (From Low Dose in Period 2)|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous low dose of olmesartan.
1230988|NCT00151775|P3|Participant Flow|Cohort A: Placebo in Period 3 (From High Dose in Period 2)|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous high dose of olmesartan
1230989|NCT00151775|P2|Participant Flow|Cohort A: Low Dose OM in Periods 2, 3|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5).
1230990|NCT00151775|P1|Participant Flow|Cohort A: High Dose OM in Periods 2, 3|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5).
1230991|NCT00151775|O1|Outcome|Cohort C: OM (Olmesartan Medoxomil)|Cohort C (1-5 years old) was given olmesartan medoxomil (OM) 0.3 mg/kg in Period 2 (open-label period) and a subgroup of Cohort C was given that dose of OM during Period 3 (double-blind, placebo-controlled period). In Period 4 (open-label period), all of Cohort C received an OM starting dose of 0.3 mg/kg. If hypertension was not controlled after two week the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
1230992|NCT00151775|O3|Outcome|Cohorts A + B: Period 4 Open-label OM|All members of Cohorts A + B (6-16 years old) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
1230993|NCT00151775|O2|Outcome|Cohort B: Period 4 Open-label OM|All members of Cohort B (6-16 years old comprised exclusively of Black participants) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
1230994|NCT00151775|O1|Outcome|Cohort A: Period 4 Open-label OM|All members of Cohort A (6-16 years old with a limit on the number of Black participants) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
1230995|NCT00151775|O2|Outcome|Cohort C: Placebo Period 3|Cohort C consisted of children from 1 to 5 years of age. There were no racial restrictions. This group was switched from its Period 2 olmesartan dose of 0.3 mg/kg to placebo.
1230996|NCT00151775|O1|Outcome|Cohort C: OM Period 3|Cohort C consisted of children from 1 to 5 years of age. There were no racial restrictions. This group continued on its Period 2 olmesartan dose of 0.3 mg/kg.
1230997|NCT00151775|O6|Outcome|Cohorts A + B: Placebo Period 3|Cohorts A + B participants were 6-16 years old. Includes participants randomized to both the high and low dose of olmesartan medoxomil suspension in period 2, and changed to placebo in period 3.
1230998|NCT00151775|O5|Outcome|Cohorts A + B: OM Period 3|Cohort A + B participants were 6-16 years old. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily in period 2, and continued that dosage into period 3.
1230999|NCT00151775|O4|Outcome|Cohort B: Placebo Period 3|Cohort B participants were 6-16 years old and comprised exclusively of Black participants. Includes participants randomized to both the high and low dose of olmesartan medoxomil suspension in period 2, and changed to placebo in period 3.
1231000|NCT00151775|O3|Outcome|Cohort B: OM Period 3|Cohort B participants were 6-16 years old and comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily in period 2, and continued that dosage into period 3.
1231001|NCT00151775|O2|Outcome|Cohort A: Placebo Period 3|Cohort A participants were 6-16 years old with a limit on the number of Black participants. Includes participants randomized to both the high and low dose of olmesartan medoxomil suspension in period 2, and changed to placebo in period 3.
1231002|NCT00151775|O1|Outcome|Cohort A: OM Period 3|Cohort A participants were 6-16 years old with a limit on the number of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily in period 2, and continued that dosage into period 3.
1231003|NCT00151775|O6|Outcome|Cohorts A + B: High Dose OM|Subgroup from Cohorts A + B (6-16 years old) who received the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg depending on weight), administered once daily in Period 2. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants.
1231004|NCT00151775|O5|Outcome|Cohorts A + B: Low Dose OM|Subgroup from Cohorts A + B (6-16 years old) who received the low dose of olmesartan medoxomil suspension (OM 2.5 mg or 5.0 mg depending on weight), administered once daily in Period 2. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants.
1231005|NCT00151775|O4|Outcome|Cohort B: High Dose OM|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
1231006|NCT00151775|O3|Outcome|Cohort B: Low Dose OM|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
1231007|NCT00151775|O2|Outcome|Cohort A: High Dose OM|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
1231008|NCT00151775|O1|Outcome|Cohort A: Low Dose OM|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
1231009|NCT00151775|O3|Outcome|Cohorts A + B|Cohort A + B participants were 6-16 years old. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily.
1231010|NCT00151775|O2|Outcome|Cohort B|Cohort B participants were 6-16 years old and comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0 mg), depending on weight, administered once daily.
1231011|NCT00151775|O1|Outcome|Cohort A|Cohort A participants were 6-16 years old with a limit on the number of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily.
1231012|NCT00151775|E18|Reported Event|Cohort C: Period 4 Open-label OM|Participants received an olmesartan medoxomil suspension (OM) starting dose of 0.3 mg/kg. If hypertension was not controlled after two week the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
1231013|NCT00151775|E17|Reported Event|Cohort C: Period 3 Placebo|The 0.3 mg/kg dose of olmesartan medoxomil suspension (OM) was discontinued for these participants. They were switched to placebo.
1231014|NCT00151775|E16|Reported Event|Cohort C: Period 3 OM Dose Continued|The 0.3 mg/kg dose of OM was continued for these participants
1231015|NCT00151775|E15|Reported Event|Cohort C: Period 2 Open-label OM|The dose of olmesartan medoxomil suspension (OM) was 0.3 mg/kg for all particpants who were 1 to 5 years of age.
1231016|NCT00151775|E14|Reported Event|Cohort B: Period 4 Open-label OM|10 mg to 40 mg of olmesartan (OM) was administered as oral suspension or tablets depending on particpant weight and response. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
1231017|NCT00151775|E13|Reported Event|Cohort B: Period 3 Placebo From Low Dose|Placebo was given instead of the previous low dose of olmesartan
1231018|NCT00151775|E12|Reported Event|Cohort B: Period 3 OM Low Dose Continued|The 2.5 mg or 5 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.
1231019|NCT00151775|E11|Reported Event|Cohort B: Period 3 Placebo From High Dose|Placebo was given instead of the previous high dose of olmesartan
1231194|NCT00150592|B1|Baseline|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
1231021|NCT00151775|E9|Reported Event|Cohort B: Period 2 Low Dose OM|For Cohort B (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 2.5 mg or 5 mg, depending on weight.
1231022|NCT00151775|E8|Reported Event|Cohort B: Period 2 High Dose OM|For Cohort A (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 20 mg or 40 mg, depending on weight.
1231023|NCT00151775|E7|Reported Event|Cohort A: Period 4 Open-label OM|10 mg to 40 mg of olmesartan (OM) was administered as oral suspension or tablets depending on participant weight and response. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
1231024|NCT00151775|E6|Reported Event|Cohort A: Period 3 Placebo From Low Dose|Placebo was given instead of the previous low dose of olmesartan
1231025|NCT00151775|E5|Reported Event|Cohort A: Period 3 OM Low Dose Continued|The 2.5 mg or 5 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.
1231026|NCT00151775|E4|Reported Event|Cohort A: Period 3 Placebo From High Dose|Placebo was given instead of the previous high dose of olmesartan
1231027|NCT00151775|E3|Reported Event|Cohort A: Period 3 OM High Dose Continued|The 20 mg or 40 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.
1231028|NCT00151775|E2|Reported Event|Cohort A: Period 2 Low Dose OM|For Cohort A (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 2.5 mg or 5 mg, depending on weight.
1231029|NCT00151775|E1|Reported Event|Cohort A: Period 2 High Dose OM|For Cohort A (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 20 mg or 40 mg, depending on weight.
1231030|NCT00151476|B4|Baseline|Total|Total of all reporting groups
1231031|NCT00151476|B3|Baseline|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231032|NCT00151476|B2|Baseline|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: all patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231033|NCT00151476|B1|Baseline|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231034|NCT00151476|P2|Participant Flow|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231035|NCT00151476|P1|Participant Flow|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: all patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231036|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231037|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231038|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231039|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231040|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231195|NCT00150592|P2|Participant Flow|Placebo|
1231808|NCT00147745|B2|Baseline|Colesevelam Matching Placebo|Colesevelam matching placebo for 12 weeks
1231041|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231042|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231043|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231044|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231045|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231046|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231047|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231048|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231049|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231050|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231051|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231052|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231053|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231054|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231199|NCT00150592|O2|Outcome|Placebo|
1231055|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231056|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231057|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231058|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231059|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231060|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231061|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231062|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231063|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231064|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231065|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231066|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231067|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231106|NCT00151372|O1|Outcome|Treatment Adherence Intervention|In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease (COPD) treatment adherence and to help the participant overcome those obstacles.
1231809|NCT00147745|B1|Baseline|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
1231068|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231069|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231070|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231071|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231072|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231073|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231074|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231075|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231076|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231077|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231078|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231079|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231080|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231107|NCT00151372|E2|Reported Event|Enhanced Care|In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.
1232554|NCT00145496|O2|Outcome|Olanzapine|5-20 mg by mouth once daily for up to 26 weeks
1231081|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231082|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231083|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231084|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231085|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231086|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231087|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231088|NCT00151476|E1|Reported Event|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
1231089|NCT00151411|B3|Baseline|Total|Total of all reporting groups
1231090|NCT00151411|B2|Baseline|Placebo|Placebo (2 tablets twice a day) initiated in a step-up fashion
1231091|NCT00151411|B1|Baseline|Metformin|Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
1231092|NCT00151411|P2|Participant Flow|Placebo|Placebo (2 tablets twice a day) initiated in a step-up fashion
1231093|NCT00151411|P1|Participant Flow|Metformin|Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
1231094|NCT00151411|O2|Outcome|Placebo|Placebo (2 tablets twice a day) initiated in a step-up fashion
1231095|NCT00151411|O1|Outcome|Metformin|Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
1231096|NCT00151411|E2|Reported Event|Placebo|Placebo (2 tablets twice a day) initiated in a step-up fashion
1231097|NCT00151411|E1|Reported Event|Metformin|Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
1231098|NCT00151372|B3|Baseline|Total|Total of all reporting groups
1231099|NCT00151372|B2|Baseline|Enhanced Care|In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.
1231100|NCT00151372|B1|Baseline|Treatment Adherence Intervention|In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease (COPD) treatment adherence and to help the participant overcome those obstacles.
1231101|NCT00151372|P2|Participant Flow|Enhanced Care|In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.
1231102|NCT00151372|P1|Participant Flow|Treatment Adherence Intervention|In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease (COPD) treatment adherence and to help the participant overcome those obstacles.
1231103|NCT00151372|O2|Outcome|Enhanced Care|In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.
1231104|NCT00151372|O1|Outcome|Treatment Adherence Intervention|In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease (COPD) treatment adherence and to help the participant overcome those obstacles.
1231105|NCT00151372|O2|Outcome|Enhanced Care|In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.
1231108|NCT00151372|E1|Reported Event|Treatment Adherence Intervention|In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease (COPD) treatment adherence and to help the participant overcome those obstacles.
1231109|NCT00151320|B3|Baseline|Total|Total of all reporting groups
1231110|NCT00151320|B2|Baseline|Untreated MCL|with untreated mantle cell Non-Hodgkin’s Lymphoma
1231111|NCT00151320|B1|Baseline|Untreated DLBCL|with untreated Diffuse Large B-cell Lymphoma (n = 40)
1231112|NCT00151320|P1|Participant Flow|Arm 1|"Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles~Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)~VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by a dose escalation schedule.~Bortezomib, CHOP, Rituximab: Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)~VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule:~Level Dose/Schedule (-2) 0.7 mg/m2 on day 1 of each cycle (-1) 0.7 mg/m2 on days 1 and 8 (0) 0.7 mg/m2 on days 1 and 4 (+1) 1.0 mg/m2 on days 1 and 4 (+2) 1.3 mg/m2 on days 1 and 4"
1231113|NCT00151320|O2|Outcome|Untreated MCL|with untreated mantle cell Non-Hodgkin’s Lymphoma
1231114|NCT00151320|O1|Outcome|Untreated DLBCL|with untreated Diffuse Large B-cell Lymphoma (n = 40)
1231115|NCT00151320|E1|Reported Event|Arm 1|"Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles~Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)~VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by a dose escalation schedule.~Bortezomib, CHOP, Rituximab: Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)~VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule:~Level Dose/Schedule (-2) 0.7 mg/m2 on day 1 of each cycle (-1) 0.7 mg/m2 on days 1 and 8 (0) 0.7 mg/m2 on days 1 and 4 (+1) 1.0 mg/m2 on days 1 and 4 (+2) 1.3 mg/m2 on days 1 and 4"
1231116|NCT00150969|B3|Baseline|Total|Total of all reporting groups
1231117|NCT00150969|B2|Baseline|Placebo|dummy pill identicle to vitamin k
1231118|NCT00150969|B1|Baseline|Phyloquinone|5 mg Vitamin K1
1231119|NCT00150969|P2|Participant Flow|Placebo|dummy pill identicle to vitamin k
1231120|NCT00150969|P1|Participant Flow|Phyloquinone|5 mg Vitamin K1
1231121|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
1231122|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
1231123|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
1231124|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
1231125|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
1231126|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
1231127|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
1231128|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
1231129|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
1231130|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
1231131|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
1231132|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
1231133|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
1231134|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
1231135|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
1231136|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
1231137|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
1231138|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
1231139|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
1231140|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1
1231141|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
1231142|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1
1231143|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
1231144|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
1231145|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
1231146|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
1231147|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
1231148|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
1231149|NCT00150969|E2|Reported Event|Placebo|dummy pill identicle to vitamin k
1231150|NCT00150969|E1|Reported Event|Phyloquinone|5 mg Vitamin K1
1231151|NCT00150618|B6|Baseline|Total|Total of all reporting groups
1231152|NCT00150618|B5|Baseline|Placebo|once daily
1231153|NCT00150618|B4|Baseline|SPD503 (4 mg)|Guanfacine HCl once daily
1231154|NCT00150618|B3|Baseline|SPD503 (3 mg)|Guanfacine HCl once daily
1231155|NCT00150618|B2|Baseline|SPD503 (2 mg)|Guanfacine HCl once daily
1231156|NCT00150618|B1|Baseline|SPD503 (1 mg)|Guanfacine HCl once daily
1231157|NCT00150618|P5|Participant Flow|Placebo|once daily
1231158|NCT00150618|P4|Participant Flow|SPD503 (4 mg)|Guanfacine HCl once daily
1231159|NCT00150618|P3|Participant Flow|SPD503 (3 mg)|Guanfacine HCl once daily
1231160|NCT00150618|P2|Participant Flow|SPD503 (2 mg)|Guanfacine HCl once daily
1231161|NCT00150618|P1|Participant Flow|SPD503 (1 mg)|Guanfacine HCl once daily
1231162|NCT00150618|O5|Outcome|Placebo|once daily
1231163|NCT00150618|O4|Outcome|SPD503 (4 mg)|Guanfacine HCl once daily
1231164|NCT00150618|O3|Outcome|SPD503 (3 mg)|Guanfacine HCl once daily
1231165|NCT00150618|O2|Outcome|SPD503 (2 mg)|Guanfacine HCl once daily
1231166|NCT00150618|O1|Outcome|SPD503 (1 mg)|Guanfacine HCl once daily
1231167|NCT00150618|O5|Outcome|Placebo|once daily
1231168|NCT00150618|O4|Outcome|SPD503 (4 mg)|Guanfacine HCl once daily
1231169|NCT00150618|O3|Outcome|SPD503 (3 mg)|Guanfacine HCl once daily
1231170|NCT00150618|O2|Outcome|SPD503 (2 mg)|Guanfacine HCl once daily
1231200|NCT00150592|O1|Outcome|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
1231201|NCT00150592|O2|Outcome|Placebo|
1231202|NCT00150592|O1|Outcome|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
1231203|NCT00150592|O2|Outcome|Placebo|
1231204|NCT00150592|O1|Outcome|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
1231205|NCT00150592|O2|Outcome|Placebo|
1231206|NCT00150592|O1|Outcome|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
1231207|NCT00150592|O2|Outcome|Placebo|
1231208|NCT00150592|O1|Outcome|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
1231209|NCT00150592|O2|Outcome|Placebo|
1231210|NCT00150592|O1|Outcome|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
1231211|NCT00150592|O2|Outcome|Placebo|
1231212|NCT00150592|O1|Outcome|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
1231213|NCT00150592|E2|Reported Event|Placebo|
1231214|NCT00150592|E1|Reported Event|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
1231215|NCT00150462|B12|Baseline|Total|Total of all reporting groups
1231216|NCT00150462|B11|Baseline|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
1231217|NCT00150462|B10|Baseline|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
1231218|NCT00150462|B9|Baseline|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231219|NCT00150462|B8|Baseline|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231220|NCT00150462|B7|Baseline|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231221|NCT00150462|B6|Baseline|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231222|NCT00150462|B5|Baseline|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231223|NCT00150462|B4|Baseline|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231224|NCT00150462|B3|Baseline|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231225|NCT00150462|B2|Baseline|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231226|NCT00150462|B1|Baseline|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231227|NCT00150462|P11|Participant Flow|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
1231228|NCT00150462|P10|Participant Flow|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
1231229|NCT00150462|P9|Participant Flow|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231230|NCT00150462|P8|Participant Flow|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231231|NCT00150462|P7|Participant Flow|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231232|NCT00150462|P6|Participant Flow|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231233|NCT00150462|P5|Participant Flow|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231234|NCT00150462|P4|Participant Flow|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231235|NCT00150462|P3|Participant Flow|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231236|NCT00150462|P2|Participant Flow|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231237|NCT00150462|P1|Participant Flow|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1232555|NCT00145496|O1|Outcome|Asenapine|5-10 mg sublingually twice daily for up to 26 weeks
1231238|NCT00150462|O10|Outcome|CFZ 20/27 mg/m² (±DEX)|Participants in the Dose Expansion phase received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
1231811|NCT00147745|P2|Participant Flow|Colesevelam Matching Placebo|Colesevelam matching placebo for 12 weeks
1231239|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231240|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231241|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231242|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231243|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231244|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231245|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231246|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231247|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231248|NCT00150462|O10|Outcome|CFZ 20/27 mg/m² (±DEX)|Participants in the Dose Expansion phase received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
1231249|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231250|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231251|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231252|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231253|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231254|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231255|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231256|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231257|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231258|NCT00150462|O10|Outcome|CFZ 20/27 mg/m² (±DEX)|Participants in the Dose Expansion phase received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
1231259|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231260|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231261|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231262|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231263|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231264|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231265|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231266|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231267|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231268|NCT00150462|O11|Outcome|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
1231269|NCT00150462|O10|Outcome|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
1231801|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
1231270|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231812|NCT00147745|P1|Participant Flow|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
1231271|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231272|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231273|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231274|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231275|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231276|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231277|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231278|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231279|NCT00150462|O11|Outcome|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
1231280|NCT00150462|O10|Outcome|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
1231281|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231282|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231283|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231284|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231285|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231286|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231287|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231288|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231289|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231290|NCT00150462|O11|Outcome|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15, and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
1231291|NCT00150462|O10|Outcome|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15, and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
1231292|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231293|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231294|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231295|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231296|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231297|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231298|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231299|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231300|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231301|NCT00150462|O11|Outcome|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
1231302|NCT00150462|O10|Outcome|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
1231303|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231304|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231305|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231306|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231307|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231308|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231309|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231310|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231311|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231312|NCT00150462|O10|Outcome|CFZ 20/27 mg/m² (±DEX)|Participants in the Dose Expansion phase received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
1231313|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231314|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231315|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231316|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231317|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231318|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231319|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231320|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231321|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231322|NCT00150462|O11|Outcome|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
1231323|NCT00150462|O10|Outcome|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
1231324|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231325|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231326|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231327|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231328|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231329|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231330|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231331|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231332|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231333|NCT00150462|E11|Reported Event|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
1231802|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
1231334|NCT00150462|E10|Reported Event|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
1231335|NCT00150462|E9|Reported Event|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231336|NCT00150462|E8|Reported Event|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231337|NCT00150462|E7|Reported Event|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231338|NCT00150462|E6|Reported Event|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231339|NCT00150462|E5|Reported Event|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231340|NCT00150462|E4|Reported Event|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231341|NCT00150462|E3|Reported Event|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231342|NCT00150462|E2|Reported Event|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231343|NCT00150462|E1|Reported Event|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
1231344|NCT00150345|B3|Baseline|Total|Total of all reporting groups
1231345|NCT00150345|B2|Baseline|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231346|NCT00150345|B1|Baseline|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231347|NCT00150345|P2|Participant Flow|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231348|NCT00150345|P1|Participant Flow|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231349|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231350|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231351|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231352|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231418|NCT00150176|E3|Reported Event|Asenapine During Open-Label Phase and Not Randomized|Adverse Events for the Open-Label period. The 'Asenapine During Open-Label Phase & Not Randomized' Group includes subjects who received >= 1 dose of asenapine during the 26 week open-label phase, and did NOT continue to double-blind phase.
1231803|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
1231484|NCT00149747|O1|Outcome|Exercise Group|"Regular, aerobic endurance physical activity~Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity"
1231353|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231354|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231355|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231356|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231357|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231358|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231359|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231360|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231361|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231362|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231363|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231364|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231419|NCT00150176|E2|Reported Event|Placebo|Adverse Events for the Double Blind Period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.
1231804|NCT00147823|E2|Reported Event|Vitoss With Bone Marrow Aspirate|subjects who received Vitoss with bone marrow aspirate
1231365|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231366|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231367|NCT00150345|O2|Outcome|Deferred Voricoazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231368|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231369|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231370|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231371|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231372|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231373|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231374|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231375|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231376|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231420|NCT00150176|E1|Reported Event|Asenapine|Adverse Events for the Double Blind Period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.
1231421|NCT00149994|B3|Baseline|Total|Total of all reporting groups
1243739|NCT00110305|O5|Outcome|Efavirenz|Efavirenz 600 mg once daily
1231377|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231378|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231379|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231380|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231381|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231382|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231383|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231384|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231385|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231386|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231387|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231388|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231445|NCT00149890|O2|Outcome|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
1231389|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231390|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231391|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231392|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231393|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231394|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231395|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231396|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231397|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231398|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231399|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231400|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231446|NCT00149890|O1|Outcome|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
1246236|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
1231401|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231402|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231403|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231404|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231405|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231406|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231407|NCT00150345|E2|Reported Event|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231408|NCT00150345|E1|Reported Event|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
1231409|NCT00150176|B3|Baseline|Total|Total of all reporting groups
1231410|NCT00150176|B2|Baseline|Placebo|Baseline for the double-blind period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.
1231411|NCT00150176|B1|Baseline|Asenapine|Baseline for the double-blind period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.
1231412|NCT00150176|P2|Participant Flow|Placebo|Double Blind Placebo Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.
1231413|NCT00150176|P1|Participant Flow|Asenapine|Double Blind Asenapine Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.
1231414|NCT00150176|O2|Outcome|Placebo|Double Blind Placebo Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.
1231415|NCT00150176|O1|Outcome|Asenapine|Double Blind Asenapine Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.
1231416|NCT00150176|O2|Outcome|Placebo|Double Blind Placebo Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.
1231417|NCT00150176|O1|Outcome|Asenapine|Double Blind Asenapine Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.
1232556|NCT00145496|O2|Outcome|Olanzapine|5-20 mg by mouth once daily for up to 26 weeks
1231422|NCT00149994|B2|Baseline|Tacrolimus|Tacrolimus was given twice-daily at 12-hour intervals. Tacrolimus was administered within the first 24 hrs post- operatively (Study Day 1) at an initial dose of 0.1-0.15 mg/kg/day in two divided oral doses either by mouth or via an enteral feeding tube until the participant can swallow. The initial dosing level was determined by the participants's overall post-operative condition. The dose of tacrolimus was adjusted to achieve and maintain the pre-dose C-Oh (trough) target ranges post-transplantation 0-3 months: 10-15 ng/ml; 4-6 months: 5-10 ng/ml and > 6 months: 5-10 ng/ml . Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for OLTx was of auto-immune in nature.
1231423|NCT00149994|B1|Baseline|Cyclosporine A|Cyclosporine A was given twice-daily at 12-hour intervals. It was administered within the first 4 hours post-operatively (study day 1), at an initial dose of 10-15mg/kg/day in two doses. Cyclosporine A was adjusted to bring the 2 hour after oral dose (C-2h) level into the target range by Days 3-5 post-transplantation. The dose of Cyclosporine A was adjusted to achieve and maintain post transplantation C-2h levels 0- 3 months: 800- 1200 ng/mL, 4- 6 months: 700- 900 ng/mL and >6 months: 500- 700 ng/mL. Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for Orthotopic Liver Transplantation (OLTx) was of auto-immune nature.
1231424|NCT00149994|P2|Participant Flow|Tacrolimus|Tacrolimus was given twice-daily at 12-hour intervals. Tacrolimus was administered within the first 24 hrs post- operatively (Study Day 1) at an initial dose of 0.1-0.15 mg/kg/day in two divided oral doses either by mouth or via an enteral feeding tube until the participant can swallow. The initial dosing level was determined by the participants's overall post-operative condition. The dose of tacrolimus was adjusted to achieve and maintain the pre-dose C-Oh (trough) target ranges post-transplantation 0-3 months: 10-15 ng/ml; 4-6 months: 5-10 ng/ml and > 6 months: 5-10 ng/ml . Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for OLTx was of auto-immune in nature.
1231425|NCT00149994|P1|Participant Flow|Cyclosporine A|Cyclosporine A was given twice-daily at 12-hour intervals. It was administered within the first 4 hours post-operatively (study day 1), at an initial dose of 10-15mg/kg/day in two doses. Cyclosporine A was adjusted to bring the 2 hour after oral dose (C-2h) level into the target range by Days 3-5 post-transplantation. The dose of Cyclosporine A was adjusted to achieve and maintain post transplantation C-2h levels 0- 3 months: 800- 1200 ng/mL, 4- 6 months: 700- 900 ng/mL and >6 months: 500- 700 ng/mL. Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for Orthotopic Liver Transplantation (OLTx) was of auto-immune nature.
1231426|NCT00149994|O2|Outcome|Tacrolimus|Tacrolimus was given twice-daily at 12-hour intervals. Tacrolimus was administered within the first 24 hrs post- operatively (Study Day 1) at an initial dose of 0.1-0.15 mg/kg/day in two divided oral doses either by mouth or via an enteral feeding tube until the participant can swallow. The initial dosing level was determined by the participants's overall post-operative condition. The dose of tacrolimus was adjusted to achieve and maintain the pre-dose C-Oh (trough) target ranges post-transplantation 0-3 months: 10-15 ng/ml; 4-6 months: 5-10 ng/ml and > 6 months: 5-10 ng/ml . Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for OLTx was of auto-immune in nature.
1231427|NCT00149994|O1|Outcome|Cyclosporine A|Cyclosporine A was given twice-daily at 12-hour intervals. It was administered within the first 4 hours post-operatively (study day 1), at an initial dose of 10-15mg/kg/day in two doses. Cyclosporine A was adjusted to bring the 2 hour after oral dose (C-2h) level into the target range by Days 3-5 post-transplantation. The dose of Cyclosporine A was adjusted to achieve and maintain post transplantation C-2h levels 0- 3 months: 800- 1200 ng/mL, 4- 6 months: 700- 900 ng/mL and >6 months: 500- 700 ng/mL. Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for Orthotopic Liver Transplantation (OLTx) was of auto-immune nature.
1231428|NCT00149994|E2|Reported Event|Cyclosporine A|Cyclosporine A was given twice-daily at 12-hour intervals. It was administered within the first 4 hours post-operatively (study day 1), at an initial dose of 10-15mg/kg/day in two doses. Cyclosporine A was adjusted to bring the 2 hour after oral dose (C-2h) level into the target range by Days 3-5 post-transplantation. The dose of Cyclosporine A was adjusted to achieve and maintain post transplantation C-2h levels 0- 3 months: 800- 1200 ng/mL, 4- 6 months: 700- 900 ng/mL and >6 months: 500- 700 ng/mL. Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for Orthotopic Liver Transplantation (OLTx) was of auto-immune nature.
1231447|NCT00149890|O2|Outcome|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
1231483|NCT00149747|O2|Outcome|Attention-Control (Health Education) Group|"Weekly general health education classes~Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity"
1247968|NCT00098059|O4|Outcome|13 to < =18 Years|
1231429|NCT00149994|E1|Reported Event|Tacrolimus|Tacrolimus was given twice-daily at 12-hour intervals. Tacrolimus was administered within the first 24 hrs post- operatively (Study Day 1) at an initial dose of 0.1-0.15 mg/kg/day in two divided oral doses either by mouth or via an enteral feeding tube until the participant can swallow. The initial dosing level was determined by the participants's overall post-operative condition. The dose of tacrolimus was adjusted to achieve and maintain the pre-dose C-Oh (trough) target ranges post-transplantation 0-3 months: 10-15 ng/ml; 4-6 months: 5-10 ng/ml and > 6 months: 5-10 ng/ml . Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for OLTx was of auto-immune in nature.
1231430|NCT00149890|B3|Baseline|Total|Total of all reporting groups
1231431|NCT00149890|B2|Baseline|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
1231432|NCT00149890|B1|Baseline|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
1231433|NCT00149890|P2|Participant Flow|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
1231434|NCT00149890|P1|Participant Flow|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
1231435|NCT00149890|O2|Outcome|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
1231436|NCT00149890|O1|Outcome|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
1231437|NCT00149890|O2|Outcome|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
1231438|NCT00149890|O1|Outcome|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
1231439|NCT00149890|O2|Outcome|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
1231440|NCT00149890|O1|Outcome|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
1231441|NCT00149890|O2|Outcome|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
1231442|NCT00149890|O1|Outcome|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
1231443|NCT00149890|O2|Outcome|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
1231444|NCT00149890|O1|Outcome|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
1231448|NCT00149890|O1|Outcome|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
1231449|NCT00149890|E2|Reported Event|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
1231450|NCT00149890|E1|Reported Event|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
1231451|NCT00149825|B3|Baseline|Total|Total of all reporting groups
1231452|NCT00149825|B2|Baseline|MED+CTRL|Escitalopram plus control therapy for insomnia in depression
1231453|NCT00149825|B1|Baseline|MED+CBTI|Escitalopram plus cognitive behavioral therapy for insomnia
1231454|NCT00149825|P2|Participant Flow|MED+CTRL|Escitalopram plus control therapy for insomnia in depression
1231455|NCT00149825|P1|Participant Flow|MED+CBTI|Escitalopram plus cognitive behavioral therapy for insomnia
1231456|NCT00149825|O2|Outcome|MED+CTRL|Escitalopram plus control therapy for insomnia in depression
1231457|NCT00149825|O1|Outcome|MED+CBTI|Escitalopram plus cognitive behavioral therapy for insomnia
1231458|NCT00149825|O2|Outcome|MED+CTRL|Escitalopram plus control therapy for insomnia in depression
1231459|NCT00149825|O1|Outcome|MED+CBTI|Escitalopram plus cognitive behavioral therapy for insomnia
1231460|NCT00149825|E2|Reported Event|MED+CTRL|Escitalopram plus control therapy for insomnia in depression
1231461|NCT00149825|E1|Reported Event|MED+CBTI|Escitalopram plus cognitive behavioral therapy for insomnia
1231462|NCT00149799|B3|Baseline|Total|Total of all reporting groups
1231463|NCT00149799|B2|Baseline|Phase II: Placebo|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
1231464|NCT00149799|B1|Baseline|Phase II: Escitalopram|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
1231465|NCT00149799|P3|Participant Flow|Phase II: Placebo|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
1231466|NCT00149799|P2|Participant Flow|Phase II: Escitalopram|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
1231467|NCT00149799|P1|Participant Flow|Phase I: Open-Label Escitalopram|Participants taking 14 weeks of open-label escitalopram. Subjects received 10 mg/d weeks 1-3, 20 mg/d weeks 4-6, and 30 mg/d thereafter.
1231468|NCT00149799|O1|Outcome|Phase I: Open-Label Escitalopram|Participants taking 14 weeks of open-label escitalopram. Subjects received 10 mg/d weeks 1-3, 20 mg/d weeks 4-6, and 30 mg/d thereafter.
1231469|NCT00149799|O2|Outcome|Phase II: Placebo|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
1231470|NCT00149799|O1|Outcome|Phase II: Escitalopram|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
1231471|NCT00149799|E3|Reported Event|Phase II: Placebo|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
1231472|NCT00149799|E2|Reported Event|Phase II: Escitalopram|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
1231473|NCT00149799|E1|Reported Event|Phase I: Open-Label Escitalopram|Participants taking 14 weeks of open-label escitalopram. Subjects received 10 mg/d weeks 1-3, 20 mg/d weeks 4-6, and 30 mg/d thereafter.
1231474|NCT00149747|B3|Baseline|Total|Total of all reporting groups
1231475|NCT00149747|B2|Baseline|Attention-Control (Health Education) Group|"Weekly general health education classes~Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity"
1231476|NCT00149747|B1|Baseline|Exercise Group|"Regular, aerobic endurance physical activity~Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity"
1231477|NCT00149747|P2|Participant Flow|Attention-Control (Health Education) Group|"Weekly general health education classes~Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity"
1231478|NCT00149747|P1|Participant Flow|Exercise Group|"Regular, aerobic endurance physical activity~Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity"
1231479|NCT00149747|O2|Outcome|Attention-Control (Health Education) Group|"Weekly general health education classes~Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity"
1231480|NCT00149747|O1|Outcome|Exercise Group|"Regular, aerobic endurance physical activity~Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity"
1231481|NCT00149747|O2|Outcome|Attention-Control (Health Education) Group|"Weekly general health education classes~Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity"
1231482|NCT00149747|O1|Outcome|Exercise Group|"Regular, aerobic endurance physical activity~Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity"
1231485|NCT00149747|E2|Reported Event|Attention-Control (Health Education) Group|"Weekly general health education classes~Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity"
1231486|NCT00149747|E1|Reported Event|Exercise Group|"Regular, aerobic endurance physical activity~Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity"
1231487|NCT00149643|B3|Baseline|Total|Total of all reporting groups
1231488|NCT00149643|B2|Baseline|Placebo|Gelatin capsules Placebo capsules,identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
1231489|NCT00149643|B1|Baseline|Fluoxetine|Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.
1231490|NCT00149643|P2|Participant Flow|Placebo|Gelatin capsules Placebo capsules,identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
1231491|NCT00149643|P1|Participant Flow|Fluoxetine|Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.
1231492|NCT00149643|O2|Outcome|Placebo|Gelatin capsules Placebo capsules,identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
1231493|NCT00149643|O1|Outcome|Fluoxetine|Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.
1231494|NCT00149643|O2|Outcome|Placebo|Gelatin capsules Placebo capsules,identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
1231495|NCT00149643|O1|Outcome|Fluoxetine|Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.
1231496|NCT00149643|O2|Outcome|Placebo|Gelatin capsules Placebo capsules,identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
1231497|NCT00149643|O1|Outcome|Fluoxetine|Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.
1231498|NCT00149643|E2|Reported Event|Placebo|Gelatin capsules Placebo capsules,identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
1231499|NCT00149643|E1|Reported Event|Fluoxetine|Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.
1231500|NCT00149630|B3|Baseline|Total|Total of all reporting groups
1231501|NCT00149630|B2|Baseline|Placebo|Inactive medication (placebo) with methadone daily during study weeks 2-13. Inactive medication will be discontinued during study weeks 14-15.
1231502|NCT00149630|B1|Baseline|Disulfiram|250 mg/day with methadone daily during study weeks 2-13. Medication will be discontinued during study weeks 14-15.
1231503|NCT00149630|P2|Participant Flow|Placebo|Inactive medication (placebo) with methadone daily during study weeks 2-13. Inactive medication will be discontinued during study weeks 14-15.
1231504|NCT00149630|P1|Participant Flow|Disulfiram|250 mg/day with methadone daily during study weeks 2-13. Medication will be discontinued during study weeks 14-15.
1231505|NCT00149630|O2|Outcome|Placebo|Inactive medication (placebo) with methadone daily during study weeks 2-13. Inactive medication will be discontinued during study weeks 14-15.
1231506|NCT00149630|O1|Outcome|Disulfiram|250 mg/day with methadone daily during study weeks 2-13. Medication will be discontinued during study weeks 14-15.
1231507|NCT00149630|O4|Outcome|Disulfiram CT/TT|Subjects who received Disulfiram with genotype CT/TT.
1231508|NCT00149630|O3|Outcome|Disulfiram CC|Subjects who received Disulfiram with genotype CC.
1231509|NCT00149630|O2|Outcome|Placebo CT/TT|Subjects who received placebo with genotype CT/TT.
1231510|NCT00149630|O1|Outcome|Placebo CC|Subjects who received placebo with a genotype of CC.
1231511|NCT00149630|E2|Reported Event|Placebo|Inactive medicine (placebo)with methadone during study weeks 2-13. Inactive medicine discontinued during study weeks 14-15.
1231512|NCT00149630|E1|Reported Event|Disulfarim|250 mg/day with methadone daily during study weeks 2-13. Study medicine discontinued during study weeks 14-15.
1231513|NCT00149227|B3|Baseline|Total|Total of all reporting groups
1231514|NCT00149227|B2|Baseline|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
1231515|NCT00149227|B1|Baseline|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
1231516|NCT00149227|P2|Participant Flow|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
1231517|NCT00149227|P1|Participant Flow|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
1231805|NCT00147823|E1|Reported Event|Vitoss Without Bone Marrow Aspirate|subjects who received Vitoss without bone marrow aspirate
1231518|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
1231519|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
1231520|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
1231521|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
1231522|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
1231523|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
1231524|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
1231525|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
1231526|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
1231527|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
1231528|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
1231529|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
1231530|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
1231531|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
1231532|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
1231533|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
1231534|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
1231535|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
1231536|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
1231567|NCT00147316|P1|Participant Flow|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
1231568|NCT00147316|O1|Outcome|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
1231569|NCT00147316|O1|Outcome|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
1231537|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
1231538|NCT00149227|E2|Reported Event|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
1231539|NCT00149227|E1|Reported Event|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
1231540|NCT00149214|B3|Baseline|Total|Total of all reporting groups
1231541|NCT00149214|B2|Baseline|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
1231542|NCT00149214|B1|Baseline|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
1231543|NCT00149214|P2|Participant Flow|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
1231544|NCT00149214|P1|Participant Flow|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
1231545|NCT00149214|O2|Outcome|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
1231546|NCT00149214|O1|Outcome|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
1231547|NCT00149214|O2|Outcome|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
1231548|NCT00149214|O1|Outcome|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
1231549|NCT00149214|O2|Outcome|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
1231550|NCT00149214|O1|Outcome|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
1231551|NCT00149214|O2|Outcome|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
1231552|NCT00149214|O1|Outcome|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
1231553|NCT00149214|O2|Outcome|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
1231554|NCT00149214|O1|Outcome|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
1231555|NCT00149214|E2|Reported Event|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
1231556|NCT00149214|E1|Reported Event|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
1231557|NCT00148954|B3|Baseline|Total|Total of all reporting groups
1231558|NCT00148954|B2|Baseline|Medtronic Family|Selected Medtronic family devices
1231559|NCT00148954|B1|Baseline|VITALITY 2|VITALITY 2 ICD
1231560|NCT00148954|P2|Participant Flow|Medtronic Family|Selected Medtronic family devices
1231561|NCT00148954|P1|Participant Flow|VITALITY 2|VITALITY 2 ICD
1231562|NCT00148954|O2|Outcome|Medtronic Family|Selected Medtronic family devices
1231563|NCT00148954|O1|Outcome|VITALITY 2|VITALITY 2 ICD
1231564|NCT00148954|E2|Reported Event|Medtronic Family|This study did not collect serious adverse events
1231565|NCT00148954|E1|Reported Event|VITALITY 2|This study did not collect serious adverse events
1231566|NCT00147316|B1|Baseline|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
1231570|NCT00147316|E1|Reported Event|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
1231571|NCT00147290|B3|Baseline|Total|Total of all reporting groups
1231572|NCT00147290|B2|Baseline|Biventricular (BiV)|Anti Tachyarrhythmia Pacing (ATP) are delivered in both ventricles
1231573|NCT00147290|B1|Baseline|Right Ventricle (RV)|Anti Tachyarrhythmia Pacing (ATP) therapies are delivered in the right ventricle
1231574|NCT00147290|P2|Participant Flow|Biventricular (BiV)|Anti Tachyarrhythmia Pacing (ATP) are delivered in both ventricles
1231575|NCT00147290|P1|Participant Flow|Right Ventricle (RV)|Anti Tachyarrhythmia Pacing (ATP) therapies are delivered in the right ventricle
1231576|NCT00147290|O2|Outcome|Biventricular (BiV)|Anti Tachyarrhythmia Pacing (ATP) are delivered in both ventricles
1231577|NCT00147290|O1|Outcome|Right Ventricle (RV)|Anti Tachyarrhythmia Pacing (ATP) therapies are delivered in the right ventricle
1231578|NCT00147277|B3|Baseline|Total|Total of all reporting groups
1231579|NCT00147277|B2|Baseline|15 Pulses Anti-Tachycardia Pacing (ATP)|15 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
1231580|NCT00147277|B1|Baseline|8 Pulses Anti-Tachycardia Pacing (ATP)|8 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
1231581|NCT00147277|P2|Participant Flow|15 Pulses Anti-Tachycardia Pacing (ATP)|15 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
1231582|NCT00147277|P1|Participant Flow|8 Pulses Anti-Tachycardia Pacing (ATP)|8 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
1231583|NCT00147277|O2|Outcome|15 Pulses Anti-Tachycardia Pacing (ATP)|15 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
1231584|NCT00147277|O1|Outcome|8 Pulses Anti-Tachycardia Pacing (ATP)|8 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
1231585|NCT00147238|B1|Baseline|Ferumoxtran-10 MRI Contrast Agent|
1231586|NCT00147238|P1|Participant Flow|Ferumoxtran-10 MRI Contrast Agent|
1231587|NCT00147238|O1|Outcome|Ferumoxtran-10 MRI Contrast Agent|
1231588|NCT00147238|E1|Reported Event|Ferumoxtran-10 MRI Contrast Agent|
1231589|NCT00147225|B7|Baseline|Total|Total of all reporting groups
1231590|NCT00147225|B6|Baseline|10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
1231591|NCT00147225|B5|Baseline|5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
1231592|NCT00147225|B4|Baseline|10 mcg/kg Pre/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy"
1231593|NCT00147225|B3|Baseline|10 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
1231594|NCT00147225|B2|Baseline|3 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
1231595|NCT00147225|B1|Baseline|1 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
1231596|NCT00147225|P6|Participant Flow|10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses) of 21-28 day treatment cycle.~Chemotherapy :~Carboplatin [area under the concentration curve (AUC) = 11]; or~AI regimen [Adriamycin 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or~High dose Ifosfamide: 14 gm/m^2."
1231597|NCT00147225|P5|Participant Flow|5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses) of 21-28 day treatment cycle.~Chemotherapy :~Carboplatin [area under the concentration curve (AUC) = 11]; or~AI regimen [Adriamycin 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or~High dose Ifosfamide: 14 gm/m^2."
1231598|NCT00147225|P4|Participant Flow|10 mcg/kg Pre/Post Chemotherapy|"Cycle 1, Chemotherapy (Control Cycle); Beginning Cycle 2, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy (post dose) of 21-28 day treatment cycle.~Chemotherapy :~Carboplatin [area under the concentration curve (AUC) = 11]; or~AI regimen [Adriamycin 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or~High dose Ifosfamide: 14 gm/m^2."
1231599|NCT00147225|P3|Participant Flow|10 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later (study cycle) of 21-28 day treatment cycle.~Chemotherapy :~Carboplatin [area under the concentration curve (AUC) = 11]; or~AI regimen [Adriamycin 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or~High dose Ifosfamide: 14 gm/m^2."
1231600|NCT00147225|P2|Participant Flow|3 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later (study cycle) of 21-28 day treatment cycle.~Chemotherapy :~Carboplatin [area under the concentration curve (AUC) = 11]; or~AI regimen [Adriamycin 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or~High dose Ifosfamide: 14 gm/m^2."
1231601|NCT00147225|P1|Participant Flow|1 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later (study cycle) of 21-28 day treatment cycle.~Chemotherapy :~Carboplatin [area under the concentration curve (AUC) = 11]; or~Adriamycin /Ifosfamide (AI) regimens [Adriamycin (Doxorubicin) 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or~High dose Ifosfamide: 14 gm/m^2"
1231602|NCT00147225|O6|Outcome|10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
1231683|NCT00148733|B3|Baseline|Total|Total of all reporting groups
1231684|NCT00148733|B2|Baseline|Placebo|"Placebo~Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
1231603|NCT00147225|O5|Outcome|5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
1231604|NCT00147225|O4|Outcome|10 mcg/kg Pre/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy"
1231605|NCT00147225|O3|Outcome|10 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
1231606|NCT00147225|O2|Outcome|3 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
1231607|NCT00147225|O1|Outcome|1 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
1231608|NCT00147225|O6|Outcome|10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
1231609|NCT00147225|O5|Outcome|5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
1231610|NCT00147225|O4|Outcome|10 mcg/kg Pre/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy"
1231611|NCT00147225|O3|Outcome|10 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
1231612|NCT00147225|O2|Outcome|3 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
1231613|NCT00147225|O1|Outcome|1 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
1231614|NCT00147225|E6|Reported Event|10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
1231615|NCT00147225|E5|Reported Event|5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
1231616|NCT00147225|E4|Reported Event|10 mcg/kg Pre/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy"
1231617|NCT00147225|E3|Reported Event|10 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
1231618|NCT00147225|E2|Reported Event|3 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
1231619|NCT00147225|E1|Reported Event|1 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
1231620|NCT00147212|B1|Baseline|Trabectedin|Experimental arm treated with trabectedin (ET-743)
1231621|NCT00147212|P1|Participant Flow|Trabectedin|Experimental arm treated with trabectedin (ET-743)
1231622|NCT00147212|O1|Outcome|Trabectedin|Men with metastatic castration resistant prostate cancer (CRPC) treated with trabectedin
1231623|NCT00147212|E1|Reported Event|Trabectedin|Experimental arm treated with trabectedin (ET-743)
1231624|NCT00147199|B3|Baseline|Total|Total of all reporting groups
1231625|NCT00147199|B2|Baseline|Placebo|Identical placebo inhalation solution
1231626|NCT00147199|B1|Baseline|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
1231627|NCT00147199|P2|Participant Flow|Placebo|Identical placebo inhalation solution
1231628|NCT00147199|P1|Participant Flow|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
1231629|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
1231630|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
1231631|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
1231632|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
1231633|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
1231634|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
1231635|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
1231636|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
1231637|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
1231638|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
1231639|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
1231640|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
1231641|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
1231642|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
1231643|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
1231644|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
1231645|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
1231646|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
1231647|NCT00147199|E2|Reported Event|Placebo|Identical placebo inhalation solution
1231648|NCT00147199|E1|Reported Event|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
1231649|NCT00148798|B3|Baseline|Total|Total of all reporting groups
1231806|NCT00147745|B4|Baseline|Total|Total of all reporting groups
1231650|NCT00148798|B2|Baseline|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
1231651|NCT00148798|B1|Baseline|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
1231652|NCT00148798|P2|Participant Flow|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
1231653|NCT00148798|P1|Participant Flow|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
1231654|NCT00148798|O2|Outcome|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
1231655|NCT00148798|O1|Outcome|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
1231656|NCT00148798|O2|Outcome|Cetuximab Concentration Before Infusion Week 7|
1231657|NCT00148798|O1|Outcome|Cetuximab Concentration at End of Infusion Week 1|
1231658|NCT00148798|O2|Outcome|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
1231659|NCT00148798|O1|Outcome|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
1231660|NCT00148798|O2|Outcome|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
1231661|NCT00148798|O1|Outcome|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
1231662|NCT00148798|O2|Outcome|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
1231663|NCT00148798|O1|Outcome|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
1231664|NCT00148798|O2|Outcome|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
1231665|NCT00148798|O1|Outcome|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
1231666|NCT00148798|O2|Outcome|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
1231667|NCT00148798|O1|Outcome|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
1231668|NCT00148798|O2|Outcome|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
1231669|NCT00148798|O1|Outcome|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
1231670|NCT00148798|E2|Reported Event|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
1231671|NCT00148798|E1|Reported Event|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
1231672|NCT00148759|B3|Baseline|Total|Total of all reporting groups
1231673|NCT00148759|B2|Baseline|Group 2|Female subjects
1231674|NCT00148759|B1|Baseline|Group 1|Male subjects
1231675|NCT00148759|P2|Participant Flow|Female Arm|Female subjects
1231676|NCT00148759|P1|Participant Flow|Male Arm|Male subjects
1231677|NCT00148759|O2|Outcome|Group 2|Female subjects
1231678|NCT00148759|O1|Outcome|Group 1|Male subjects
1231679|NCT00148759|O2|Outcome|Group 2|Female subjects
1231680|NCT00148759|O1|Outcome|Group 1|Male subjects
1231681|NCT00148759|E2|Reported Event|Group 2|Female subjects
1231682|NCT00148759|E1|Reported Event|Group 1|Male subjects
1231685|NCT00148733|B1|Baseline|Zinc|"Zinc sulphate 10 or 20 mg (elemental zinc) per day. Intervention and placebo given perorally mixed with approximately 5 mL of breastmilk or clean water~Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
1231686|NCT00148733|P2|Participant Flow|Placebo|"Placebo~Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
1231687|NCT00148733|P1|Participant Flow|Zinc|"Zinc sulphate 10 or 20 mg (elemental zinc) per day. Intervention and placebo given perorally mixed with approximately 5 mL of breastmilk or clean water~Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
1231688|NCT00148733|O2|Outcome|Placebo|"Placebo~Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
1231689|NCT00148733|O1|Outcome|Zinc|"Zinc sulphate 10 or 20 mg (elemental zinc) per day. Intervention and placebo given perorally mixed with approximately 5 mL of breastmilk or clean water~Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
1231690|NCT00148733|E2|Reported Event|Placebo|"Placebo~Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
1231691|NCT00148733|E1|Reported Event|Zinc|"Zinc sulphate 10 or 20 mg (elemental zinc) per day. Intervention and placebo given perorally mixed with approximately 5 mL of breastmilk or clean water~Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
1231692|NCT00148668|B3|Baseline|Total|Total of all reporting groups
1231693|NCT00148668|B2|Baseline|Arm 2|Taxotere/carboplatin/herceptin
1231694|NCT00148668|B1|Baseline|Arm 1|Herceptin/navelbine
1231695|NCT00148668|P2|Participant Flow|Taxotere/Carboplatin/Herceptin|Taxotere (75mg/kg2)/carboplatin (AUC6)/herceptin(2mg/kg)[TC q 3 weeks/H q 1 wk) x 4 cycles
1231696|NCT00148668|P1|Participant Flow|Herceptin/Navelbine|Herceptin( 2mg/kg)navelbine (25mg/kg2) x 12 weeks
1231697|NCT00148668|O2|Outcome|Arm 2|Taxotere/carboplatin/herceptin
1231698|NCT00148668|O1|Outcome|Arm 1|Herceptin/navelbine
1231699|NCT00148668|E2|Reported Event|Arm 2|Taxotere/carboplatin/herceptin
1231700|NCT00148668|E1|Reported Event|Arm 1|Herceptin/navelbine
1231701|NCT00148122|B1|Baseline|Arm 1|"Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, &15)~Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.~Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule."
1231702|NCT00148122|P1|Participant Flow|Docetaxel and Capecitabine|"Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, &15)~Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.~Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule."
1231703|NCT00148122|O1|Outcome|Arm 1|"Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, &15)~Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.~Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule."
1231704|NCT00148122|O1|Outcome|Arm 1|"Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, &15)~Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.~Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule."
1231705|NCT00148122|O1|Outcome|Arm 1|"Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, &15)~Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.~Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule."
1231706|NCT00148122|E1|Reported Event|Arm 1|"Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, &15)~Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.~Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule."
1231707|NCT00148109|B3|Baseline|Total|Total of all reporting groups
1231708|NCT00148109|B2|Baseline|Epidermal Growth Factor Receptor Positive|Sarcoma expresses Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
1231709|NCT00148109|B1|Baseline|Epidermal Growth Factor Receptor Negative|Sarcoma does not express Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
1231797|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
1231810|NCT00147745|P3|Participant Flow|Open-label Insulin Glargine|open-label Insulin Glargine for 12 weeks
1243714|NCT00110305|B2|Baseline|TMC278 75 mg|TMC278 75 mg once daily
1231710|NCT00148109|P2|Participant Flow|Epidermal Growth Factor Receptor Positive|Sarcoma expresses Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
1231711|NCT00148109|P1|Participant Flow|Epidermal Growth Factor Receptor Negative|Sarcoma does not express Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
1231712|NCT00148109|O2|Outcome|Epidermal Growth Factor Receptor Positive|Tumor did express epidermal growth factor receptor
1231713|NCT00148109|O1|Outcome|Epidermal Growth Factor Receptor Negative|Tumor did not express epidermal growth factor receptor
1231714|NCT00148109|O2|Outcome|Epidermal Growth Factor Receptor Positive|Tumor did express epidermal growth factor receptor
1231715|NCT00148109|O1|Outcome|Epidermal Growth Factor Receptor Negative|Tumor did not express epidermal growth factor receptor
1231716|NCT00148109|O2|Outcome|Epidermal Growth Factor Receptor Positive|Tumor did express epidermal growth factor receptor
1231717|NCT00148109|O1|Outcome|Epidermal Growth Factor Receptor Negative|Tumor did not express epidermal growth factor receptor
1231718|NCT00148109|E2|Reported Event|Epidermal Growth Factor Receptor Positive|Sarcoma expresses Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
1231719|NCT00148109|E1|Reported Event|Epidermal Growth Factor Receptor Negative|Sarcoma does not express Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
1231720|NCT00147030|B3|Baseline|Total|Total of all reporting groups
1231721|NCT00147030|B2|Baseline|Non-cooled|Standard intensive care
1231722|NCT00147030|B1|Baseline|Cooled|Whole body mild induced hypothermia 72 hours, commencing by 6 hours of age followed by re-warming to normothermia.
1231723|NCT00147030|P2|Participant Flow|Non-cooled|Standard intensive care at normothermia
1231724|NCT00147030|P1|Participant Flow|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
1231725|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
1231726|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
1231727|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
1231728|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
1231729|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
1231730|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
1231731|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
1231732|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
1231733|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
1231734|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
1231735|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
1231736|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
1231737|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
1231738|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
1231739|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
1231740|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
1231741|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
1231742|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
1231743|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
1231798|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
1231799|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
1231744|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
1231745|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
1231746|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours, followed by normothermia.
1231747|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
1231748|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
1231749|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
1231750|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
1231751|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
1231752|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
1231753|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
1231754|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
1231755|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
1231756|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
1231757|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
1231758|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
1231759|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
1231760|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
1231761|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
1231762|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
1231763|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
1231764|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
1231765|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
1231766|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
1231767|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
1231768|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours, followed by normothermia.
1231769|NCT00147030|E2|Reported Event|Non-cooled|Standard intensive care
1231770|NCT00147030|E1|Reported Event|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
1231771|NCT00147966|B1|Baseline|Ritxumab|Rituximab at a dose of 1000 mg was given intravenously over 4-5 hours on day 0, and again on day 14.
1231772|NCT00147966|P1|Participant Flow|Ritxumab|Rituximab at a dose of 1000 mg was given intravenously over 4-5 hours on day 0, and again on day 14.
1231773|NCT00147966|O1|Outcome|Ritxumab|Rituximab at a dose of 1000 mg was given intravenously over 4-5 hours on day 0, and again on day 14.
1231774|NCT00147966|E1|Reported Event|Ritxumab|Rituximab at a dose of 1000 mg was given intravenously over 4-5 hours on day 0, and again on day 14.
1231775|NCT00147823|B3|Baseline|Total|Total of all reporting groups
1231776|NCT00147823|B2|Baseline|Vitoss Only|Vitoss: Synthetic bone graft material alone
1231777|NCT00147823|B1|Baseline|Vitoss Used With Bone Marrow Aspirate|Vitoss: Synthetic bone graft material mixed with Bone Marrow aspirate
1231778|NCT00147823|P2|Participant Flow|Vitoss With Bone Marrow Aspirate|"Addition of Vitoss to the bone marrow aspirate~Vitoss : Synthetic bone graft material"
1231779|NCT00147823|P1|Participant Flow|Vitoss Alone|No bone marrow aspirate used
1231780|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
1231781|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
1231782|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
1231783|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
1231784|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
1231785|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
1231786|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
1231787|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
1231788|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
1231789|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
1231790|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
1231791|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
1231792|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
1231793|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
1231794|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
1231795|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
1231796|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
1231800|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
1231813|NCT00147745|O1|Outcome|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
1231814|NCT00147745|O3|Outcome|Open-label Insulin Glargine|open-label Insulin Glargine for 12 weeks
1231815|NCT00147745|O2|Outcome|Colesevelam Matching Placebo|Colesevelam matching placebo for 12 weeks
1231816|NCT00147745|O1|Outcome|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
1231817|NCT00147745|O3|Outcome|Open-label Insulin Glargine|open-label Insulin Glargine for 12 weeks
1231818|NCT00147745|O2|Outcome|Colesevelam Matching Placebo|Colesevelam matching placebo for 12 weeks
1231819|NCT00147745|O1|Outcome|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
1231820|NCT00147745|O3|Outcome|Open-label Insulin Glargine|open-label Insulin Glargine for 12 weeks
1231821|NCT00147745|O2|Outcome|Colesevelam Matching Placebo|Colesevelam matching placebo for 12 weeks
1231822|NCT00147745|O1|Outcome|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
1231823|NCT00147745|O3|Outcome|Open-label Insulin Glargine|open-label Insulin Glargine for 12 weeks
1231824|NCT00147745|O2|Outcome|Colesevelam Matching Placebo|Colesevelam matching placebo for 12 weeks
1231825|NCT00147745|O1|Outcome|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
1231826|NCT00147745|E3|Reported Event|Open-label Insulin Glargine|open-label Insulin Glargine for 12 weeks
1231827|NCT00147745|E2|Reported Event|Colesevelam Matching Placebo|Colesevelam matching placebo for 12 weeks
1231828|NCT00147745|E1|Reported Event|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
1231829|NCT00147537|B5|Baseline|Total|Total of all reporting groups
1231830|NCT00147537|B4|Baseline|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231831|NCT00147537|B3|Baseline|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231832|NCT00147537|B2|Baseline|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231833|NCT00147537|B1|Baseline|CP-751,871 + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05/0.1/0.8/1.5/3/6/10/20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231834|NCT00147537|P11|Participant Flow|Paclitaxel(P)+Carboplatin(C) (Phase 2)|Paclitaxel (P) 200 mg/square meter (m^2) IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin (C) at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231835|NCT00147537|P10|Participant Flow|CP-751,871(F)+Paclitaxel(P)+Carboplatin(C) (Phase 2)|Single intravenous (IV) dose of CP‑751,871 (F) 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel (P) 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin (C) at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231836|NCT00147537|P9|Participant Flow|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231837|NCT00147537|P8|Participant Flow|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231838|NCT00147537|P7|Participant Flow|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231839|NCT00147537|P6|Participant Flow|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1232083|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
1232084|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
1232085|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
1231840|NCT00147537|P5|Participant Flow|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231841|NCT00147537|P4|Participant Flow|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231842|NCT00147537|P3|Participant Flow|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231843|NCT00147537|P2|Participant Flow|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231844|NCT00147537|P1|Participant Flow|CP-751,871 0.05 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231845|NCT00147537|O4|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2 NR)|Phase 2 Non-Randomized (NR) Extension Cohort. Single intravenous (IV) dose of CP‑751,871 20 mg/kg IV over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231846|NCT00147537|O3|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231847|NCT00147537|O2|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231848|NCT00147537|O1|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 mg/kg IV over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231849|NCT00147537|O4|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2 NR)|Phase 2 Non-Randomized (NR) Extension Cohort. Single intravenous (IV) dose of CP‑751,871 20 mg/kg IV over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231850|NCT00147537|O3|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231851|NCT00147537|O2|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231852|NCT00147537|O1|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 mg/kg IV over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231853|NCT00147537|O4|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2 NR)|Phase 2 Non-Randomized (NR) Extension Cohort. Single intravenous (IV) dose of CP‑751,871 20 mg/kg IV over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231854|NCT00147537|O3|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1232052|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
1232053|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
1232054|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
1231855|NCT00147537|O2|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231856|NCT00147537|O1|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 mg/kg IV over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231857|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231858|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231859|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231860|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231861|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231862|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231863|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231864|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231865|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231866|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231867|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231868|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231869|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231870|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231871|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin + Additional CP-751,871 (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 day cycle. Participants that were considered to be in stable disease after at least 4 cycles of treatment or in progressive disease at any time during the study could receive additional cycles of treatment with CP-751,871 in combination with Paclitaxel and Carboplatin or CP-751,871 alone.
1232055|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
1231872|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231873|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231874|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231875|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231876|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231877|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231878|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231879|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231880|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231881|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231882|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231883|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231884|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1232056|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
1232057|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
1232058|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
1231885|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231886|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231887|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231888|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231889|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231890|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231891|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231892|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231893|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231894|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231895|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231896|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231897|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1232059|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
1232060|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
1232557|NCT00145496|O1|Outcome|Asenapine|5-10 mg sublingually twice daily for up to 26 weeks
1231898|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231899|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231900|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231901|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231902|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231903|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231904|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter (mg/mL), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231905|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231906|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231907|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231908|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231909|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231910|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1232061|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
1232062|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
1232063|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
1231911|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231912|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231913|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231914|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231915|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231916|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231917|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231918|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231919|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231920|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231921|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231922|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231923|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1232064|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
1232065|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
1247969|NCT00098059|O3|Outcome|6 to <=12 Years|
1231924|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231925|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231926|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231927|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231928|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231929|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231930|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231931|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231932|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231933|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231934|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231935|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231936|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1232066|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
1232067|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
1232068|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
1231937|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231938|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231939|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231940|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231941|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231942|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231943|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231944|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231945|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231946|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231947|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231948|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231949|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1232069|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
1232070|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
1247970|NCT00098059|O2|Outcome|2 to <6 Years|
1231950|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231951|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231952|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231953|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231954|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231955|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231956|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231957|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231958|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231959|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231960|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231961|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231962|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1232071|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
1232072|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
1232558|NCT00145496|O2|Outcome|Olanzapine|5-20 mg by mouth once daily for up to 26 weeks
1231963|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231964|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231965|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231966|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231967|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231968|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231969|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231970|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231971|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231972|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231973|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231974|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231975|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1232073|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
1232074|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
1232075|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
1231976|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231977|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231978|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231979|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231980|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231981|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231982|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231983|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231984|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231985|NCT00147537|O8|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231986|NCT00147537|O7|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231987|NCT00147537|O6|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231988|NCT00147537|O5|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1232076|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
1232077|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
1232078|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
1231989|NCT00147537|O4|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231990|NCT00147537|O3|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231991|NCT00147537|O2|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231992|NCT00147537|O1|Outcome|CP-751,871 0.05 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231993|NCT00147537|O8|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231994|NCT00147537|O7|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231995|NCT00147537|O6|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231996|NCT00147537|O5|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231997|NCT00147537|O4|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231998|NCT00147537|O3|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1231999|NCT00147537|O2|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1232000|NCT00147537|O1|Outcome|CP-751,871 0.05 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1232001|NCT00147537|O2|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1232079|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
1232080|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
1232081|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
1232002|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05/0.1/0.8/1.5/3/6/10/20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1232003|NCT00147537|O2|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1232004|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05/0.1/0.8/1.5/3/6/10/20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1232005|NCT00147537|O1|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1232006|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1232007|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1232008|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05/0.1/0.8/1.5/3/6/10/20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1232009|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05/0.1/0.8/1.5/3/6/10/20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1232010|NCT00147537|E12|Reported Event|Paclitaxel + Carboplatin + Additional CP-751,871 (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 day cycle. Participants that were considered to be in stable disease after at least 4 cycles of treatment or in progressive disease at any time during the study could receive additional cycles of treatment with CP-751,871 in combination with Paclitaxel and Carboplatin or CP-751,871 alone.
1232011|NCT00147537|E11|Reported Event|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1232012|NCT00147537|E10|Reported Event|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1232013|NCT00147537|E9|Reported Event|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1232014|NCT00147537|E8|Reported Event|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1232015|NCT00147537|E7|Reported Event|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1232082|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
1232559|NCT00145496|O1|Outcome|Asenapine|5-10 mg sublingually twice daily for up to 26 weeks
1232016|NCT00147537|E6|Reported Event|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1232017|NCT00147537|E5|Reported Event|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1232018|NCT00147537|E4|Reported Event|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1232019|NCT00147537|E3|Reported Event|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1232020|NCT00147537|E2|Reported Event|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1232021|NCT00147537|E1|Reported Event|CP-751,871 0.05 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
1232022|NCT00147498|B5|Baseline|Total|Total of all reporting groups
1232023|NCT00147498|B4|Baseline|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
1232024|NCT00147498|B3|Baseline|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
1232025|NCT00147498|B2|Baseline|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
1232026|NCT00147498|B1|Baseline|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
1232027|NCT00147498|P4|Participant Flow|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
1232028|NCT00147498|P3|Participant Flow|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
1232029|NCT00147498|P2|Participant Flow|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
1232030|NCT00147498|P1|Participant Flow|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
1232031|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
1232032|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
1232033|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
1232034|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
1232035|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
1232036|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
1232037|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
1232038|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
1232039|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
1232040|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
1232041|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
1232042|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
1232043|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
1232044|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
1232045|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
1232046|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
1232047|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
1232048|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
1232049|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
1232050|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
1232051|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
1232086|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
1232087|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
1232088|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
1232089|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
1232090|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
1232091|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
1232092|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
1232093|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
1232094|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
1232095|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
1232096|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
1232097|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
1232098|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
1232099|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
1232100|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
1232101|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
1232102|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
1232103|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
1232104|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
1232105|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
1232106|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
1232107|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
1232108|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
1232109|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
1232110|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
1232111|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
1232112|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
1232113|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
1232114|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
1232115|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
1232116|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
1232117|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
1232118|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
1232119|NCT00147498|E4|Reported Event|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
1232120|NCT00147498|E3|Reported Event|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
1232121|NCT00147498|E2|Reported Event|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
1232122|NCT00147498|E1|Reported Event|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
1232123|NCT00147446|B3|Baseline|Total|Total of all reporting groups
1232124|NCT00147446|B2|Baseline|Wait List Control Condition|Wait list control provided treatment as usual for the first 10+ months of participation. A 5-hour workshop was provided after the 10th month. This allowed at least 2 post-treatment MRI evaluations that were not contaminated by the workshop
1232125|NCT00147446|B1|Baseline|Stress Management Therapy for Multiple Sclerosis|Stress management therapy for multiple sclerosis(SMT-MS)at baseline
1232126|NCT00147446|P2|Participant Flow|Wait List Control Condition|Wait list control provided treatment as usual for the first 10+ months of participants. A 5-hour workshop was provided afte the 10th month. This allowed at least 2 post-treatment MRI evaluations that were not contaminated by the workshop.
1232127|NCT00147446|P1|Participant Flow|Stress Management Therapy for Mulitple Sclerosis|Stress management therapy for MS(SMT-MS), provided 16 individual treatment sessions over 24 weeks, followed by a 24-week post-treatment follow-up.
1232128|NCT00147446|O2|Outcome|Wait List Control Condition|Wait list control provided treatment as usual for the first 10+ months of participants. A 5-hour workshop was provided afte the 10th month. This allowed at least 2 post-treatment MRI evaluations that were not contaminated by the workshop.
1232129|NCT00147446|O1|Outcome|Stress Management Therapy for Mulitple Sclerosis|Stress management therapy for MS(SMT-MS), provided 16 individual treatment sessions over 24 weeks, followed by a 24-week post-treatment follow-up.
1232416|NCT00145600|O1|Outcome|Patient At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
1232130|NCT00147446|O2|Outcome|Wait List Control Condition|Wait list control(WLC) provided treatment as usual for the first 10+ months of participants. A 5-hour workshop was provided after the 10th month. This allowed at least 2 post-treatment MRI evaluations that were not contaminated by the workshop
1232758|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232131|NCT00147446|O1|Outcome|Stress Management Therapy for Multiple Sclerosis|Stress management therapy for MS(SMT-MS), provided 16 individual treatment sessions over 24 weeks, followed by a 24-week post-treatment follow-up.
1232132|NCT00147446|E2|Reported Event|Wait List Control Condition|Wait list control provided treatment as usual for the first 10+ months of participants. A 5-hour workshop was provided after the 10th month. This allowed at least 2 post-treatment MRI evaluations that were not contaminated by the workshop
1232133|NCT00147446|E1|Reported Event|Stress Management Therapy for Multiple Sclerosis|Stress management therapy for MS(SMT-MS, provided 16 individual treatment sessions over 24 weeks, followed by a 24-week post-treatment follow-up.
1232134|NCT00146848|B4|Baseline|Total|Total of all reporting groups
1232135|NCT00146848|B3|Baseline|DDDR-40|Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
1232136|NCT00146848|B2|Baseline|DDD-70|Atrial Rate Support (atrial rate support above 70 bpm)
1232137|NCT00146848|B1|Baseline|DDD-40|Atrial Tracking (atrial rate support above 40 bpm)
1232138|NCT00146848|P3|Participant Flow|DDDR-40|Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
1232139|NCT00146848|P2|Participant Flow|DDD-70|Atrial Rate Support (atrial rate support above 70 bpm)
1232140|NCT00146848|P1|Participant Flow|DDD-40|Atrial Tracking (atrial rate support above 40 bpm)
1232141|NCT00146848|O3|Outcome|DDDR-40|Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
1232142|NCT00146848|O2|Outcome|DDD-70|Atrial Rate Support (atrial rate support above 70 bpm)
1232143|NCT00146848|O1|Outcome|DDD-40|Atrial Tracking (atrial rate support above 40 bpm)
1232144|NCT00146848|O3|Outcome|DDDR-40|Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
1232145|NCT00146848|O2|Outcome|DDD-70|Atrial Rate Support (atrial rate support above 70 bpm)
1232146|NCT00146848|O1|Outcome|DDD-40|Atrial Tracking (atrial rate support above 40 bpm)
1232147|NCT00146848|O3|Outcome|DDDR-40|Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
1232148|NCT00146848|O2|Outcome|DDD-70|Atrial Rate Support (atrial rate support above 70 bpm)
1232149|NCT00146848|O1|Outcome|DDD-40|Atrial Tracking (atrial rate support above 40 bpm)
1232150|NCT00146848|E3|Reported Event|DDDR-40|Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
1232151|NCT00146848|E2|Reported Event|DDD-70|Atrial Rate Support (atrial rate support above 70 bpm)
1232152|NCT00146848|E1|Reported Event|DDD-40|Atrial Tracking (atrial rate support above 40 bpm)
1232153|NCT00146770|B3|Baseline|Total|Total of all reporting groups
1232154|NCT00146770|B2|Baseline|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment.
1232155|NCT00146770|B1|Baseline|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment.
1232156|NCT00146770|P2|Participant Flow|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement prior to randomization in the Double-Blind Study.
1232157|NCT00146770|P1|Participant Flow|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
1232158|NCT00146770|O2|Outcome|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement prior to randomization in the Double-Blind Study.
1232159|NCT00146770|O1|Outcome|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
1232160|NCT00146770|O2|Outcome|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement prior to randomization in the Double-Blind Study.
1232161|NCT00146770|O1|Outcome|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
1232162|NCT00146770|O2|Outcome|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement prior to randomization in the Double-Blind Study.
1232163|NCT00146770|O1|Outcome|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
1232164|NCT00146770|O2|Outcome|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement prior to randomization in the Double-Blind Study.
1232549|NCT00145496|B3|Baseline|Total|Total of all reporting groups
1232165|NCT00146770|O1|Outcome|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
1232166|NCT00146770|O2|Outcome|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement prior to randomization in the Double-Blind Study.
1232167|NCT00146770|O1|Outcome|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
1232168|NCT00146770|O2|Outcome|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement prior to randomization in the Double-Blind Study.
1232169|NCT00146770|O1|Outcome|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
1232170|NCT00146770|O2|Outcome|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement prior to randomization in the Double-Blind Study.
1232171|NCT00146770|O1|Outcome|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
1232172|NCT00146770|E2|Reported Event|"Aldurazyme/|Aldurazyme***Check Title***"|"Aldurazyme/|Aldurazyme***Check Description***"
1232173|NCT00146770|E1|Reported Event|"Placebo/|Aldurazyme***Check Title***"|"Placebo/|Aldurazyme***Check Description***"
1232174|NCT00146757|B1|Baseline|Arms 1 and 2 Combined|
1232175|NCT00146757|P2|Participant Flow|Aldurazyme (rhIDU) 100-200 U/kg Every Week|After receiving 100 Units/kg dose of Aldurazyme (rhIDU) for the first 25 weeks, patients enrolling after January 1, 2004 were eligible to receive an increased dose of 200 Units/kg from Week 26 onwards if the patient’s urinary glycosaminoglycan (uGAG) levels were >200µg/mg creatinine at Week 22.
1232176|NCT00146757|P1|Participant Flow|Aldurazyme (rhIDU) 100 U/kg Every Week|Patients received Aldurazyme (recombinant human alpha-L-iduronidase (rhIDU)) once per week at a dose of 100 Units/kg (approximately 0.58 mg/kg) for up to 52 weeks – labeled dose.
1232177|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
1232178|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
1232179|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
1232180|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
1232181|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
1232182|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
1232183|NCT00146757|O2|Outcome|Aldurazyme (rhIDU) 100-200 U/kg Every Week|After receiving 100 Units/kg dose of Aldurazyme (rhIDU) for the first 25 weeks, patients enrolling after January 1, 2004 were eligible to receive an increased dose of 200 Units/kg from Week 26 onwards if the patient’s urinary glycosaminoglycan (uGAG) levels were >200µg/mg creatinine at Week 22.
1232184|NCT00146757|O1|Outcome|Aldurazyme (rhIDU) 100 U/kg Every Week|Patients received Aldurazyme (recombinant human alpha-L-iduronidase (rhIDU)) once per week at a dose of 100 Units/kg (approximately 0.58 mg/kg) for up to 52 weeks – labeled dose.
1232185|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
1232186|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
1232187|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
1232188|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
1232189|NCT00146757|O2|Outcome|Aldurazyme (rhIDU) 100-200 U/kg Every Week|After receiving 100 Units/kg dose of Aldurazyme (rhIDU) for the first 25 weeks, patients enrolling after January 1, 2004 were eligible to receive an increased dose of 200 Units/kg from Week 26 onwards if the patient’s urinary glycosaminoglycan (uGAG) levels were >200µg/mg creatinine at Week 22.
1232190|NCT00146757|O1|Outcome|Aldurazyme (rhIDU) 100 U/kg Every Week|Patients received Aldurazyme (recombinant human alpha-L-iduronidase (rhIDU)) once per week at a dose of 100 Units/kg (approximately 0.58 mg/kg) for up to 52 weeks – labeled dose.
1232191|NCT00146757|E1|Reported Event|Aldurazyme ***Check Title***|Aldurazyme ***check title***
1232192|NCT00146328|B4|Baseline|Total|Total of all reporting groups
1232193|NCT00146328|B3|Baseline|Group 3 (Tipranavir naïve Patients)|A total of 995 patients who entered 1182.17 from a 'core' TPV/r trial were treated with TPV/r and were included in the integrated database. Of the 995 patients from 241 sites in 19 countries worldwide, 449 patients were categorized into Group 3. Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.
1232194|NCT00146328|B2|Baseline|Group 2 (Highly Treatment Experienced Patients)|A total of 995 patients who entered 1182.17 from a 'core' TPV/r trial were treated with TPV/r and were included in the integrated database. Of the 995 patients from 241 sites in 19 countries worldwide, 255 patients were categorized into Group 2. Group 2: Patients from 1182.51 who rolled over into 1182.17.
1232195|NCT00146328|B1|Baseline|Group 1 (Patients With Varying Degrees of Treatment Experience|A total of 995 patients who entered 1182.17 from a 'core' TPV/r trial were treated with TPV/r and were included in the integrated database. Of the 995 patients from 241 sites in 19 countries worldwide, 291 patients were categorized into Group 1. Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48.
1232196|NCT00146328|P3|Participant Flow|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
1232749|NCT00144339|O1|Outcome|Placebo|Once daily
1232197|NCT00146328|P2|Participant Flow|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
1232458|NCT00145600|O3|Outcome|Unfavorable Risk, Group 1|Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).
1232198|NCT00146328|P1|Participant Flow|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
1232199|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
1232200|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
1232201|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
1232202|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
1232203|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
1232204|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
1232205|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
1232206|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
1232207|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
1232208|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
1232209|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
1232210|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
1232211|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
1232212|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
1232213|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
1232214|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
1232215|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
1232216|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
1232217|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
1232218|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
1232219|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
1232220|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
1232221|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
1232222|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
1232223|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
1247971|NCT00098059|O1|Outcome|1 to < 2 Years|
1232224|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
1232225|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
1232226|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
1232227|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
1232228|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
1232229|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
1232230|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
1232231|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
1232232|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
1232233|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
1232234|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
1232235|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
1232236|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
1232237|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
1232238|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
1232239|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
1232240|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
1232241|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
1232242|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
1232243|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
1232244|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
1232245|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
1232246|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
1232247|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
1232248|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
1232249|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
1232250|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
1232550|NCT00145496|B2|Baseline|Olanzapine|5-20 mg by mouth once daily for up to 26 weeks
1232251|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
1232252|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
1232253|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
1232254|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
1232255|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
1232256|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
1232257|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
1232258|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
1232259|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
1232260|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
1232261|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
1232262|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
1232263|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
1232264|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
1232265|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
1232266|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
1232267|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
1232268|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
1232269|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
1232270|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
1232271|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
1232272|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
1232273|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
1232274|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
1232275|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
1232276|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
1232277|NCT00146328|E3|Reported Event|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
1232551|NCT00145496|B1|Baseline|Asenapine|5-10 mg sublingually twice daily for up to 26 weeks
1232278|NCT00146328|E2|Reported Event|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
1232279|NCT00146328|E1|Reported Event|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
1232280|NCT00145795|B3|Baseline|Total|Total of all reporting groups
1232281|NCT00145795|B2|Baseline|Current Regimen|Patients in this study arm continued their current regimen.
1232282|NCT00145795|B1|Baseline|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
1232283|NCT00145795|P2|Participant Flow|Current Regimen|Patients in this study arm continued their current regimen.
1232284|NCT00145795|P1|Participant Flow|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
1232285|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
1232286|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
1232287|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
1232288|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
1232289|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
1232290|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
1232291|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
1232292|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
1232293|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
1232294|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
1232295|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
1232296|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
1232297|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
1232298|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
1232299|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
1232300|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
1232301|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
1232302|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
1232303|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
1232304|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
1232305|NCT00145795|E2|Reported Event|Current Regimen|Patients in this study arm continued their current regimen.
1232306|NCT00145795|E1|Reported Event|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
1232307|NCT00145704|B3|Baseline|Total|Total of all reporting groups
1232308|NCT00145704|B2|Baseline|Growth Hormone Only|Growth hormone use only, no bisphosphonate used
1232309|NCT00145704|B1|Baseline|Bisphosphonate and Growth Hormone Use|bisphosphonate use and growth hormone use
1232310|NCT00145704|P2|Participant Flow|Growth Hormone Only|Growth hormone only, no bisphosphonate will be used
1232311|NCT00145704|P1|Participant Flow|Bisphosphonate and Growth Hormone|bisphosphonate use and growth hormone use
1232312|NCT00145704|O2|Outcome|Growth Hormone Only|Growth hormone use only, no bisphosphonate used
1232313|NCT00145704|O1|Outcome|Bisphosphonate and Growth Hormone Use|bisphosphonate use and growth hormone use
1232314|NCT00145704|E2|Reported Event|Growth Hormone Only|Growth hormone use only, no bisphosphonate used
1232315|NCT00145704|E1|Reported Event|Bisphosphonate and Growth Hormone Use|bisphosphonate use and growth hormone use
1232316|NCT00145626|B3|Baseline|Total|Total of all reporting groups
1232317|NCT00145626|B2|Baseline|Expired|"Those participants who did not survive to at least one year post HSCT.~Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
1232318|NCT00145626|B1|Baseline|Alive|"Group of participants who survived to at least one year post HSCT.~Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
1232319|NCT00145626|P1|Participant Flow|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days post-transplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
1232377|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
1232378|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
1232757|NCT00144339|O1|Outcome|Placebo|Once daily
1232320|NCT00145626|O3|Outcome|Study Participants|"MRD data were collected on four study participants. Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
1232321|NCT00145626|O2|Outcome|Expired|Those participants who did not survive to at least one year post HSCT.
1232322|NCT00145626|O1|Outcome|Alive|Group of participants who survived to at least one year post HSCT.
1232323|NCT00145626|O3|Outcome|Study Participants|"Fourteen study participants were evaluable for the outcome measures. Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
1232324|NCT00145626|O2|Outcome|Expired|Those participants who did not survive to at least one year post HSCT.
1232325|NCT00145626|O1|Outcome|Alive|Group of participants who survived to at least one year post HSCT.
1232326|NCT00145626|O3|Outcome|Study Participants|"Fourteen study participants were evaluable for the outcome measures. Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
1232327|NCT00145626|O2|Outcome|Expired|Those participants who did not survive to at least one year post HSCT.
1232328|NCT00145626|O1|Outcome|Alive|Group of participants who survived to at least one year post HSCT.
1232329|NCT00145626|O3|Outcome|Study Participants|"Fourteen study participants were evaluable for the outcome measures. Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
1232330|NCT00145626|O2|Outcome|Expired|Those participants who did not survive to at least one year post HSCT.
1232331|NCT00145626|O1|Outcome|Alive|Group of participants who survived to at least one year post HSCT.
1232332|NCT00145626|O3|Outcome|Study Participants|"Fourteen study participants were evaluable for the outcome measures. Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
1232333|NCT00145626|O2|Outcome|Expired|Those participants who did not survive to at least one year post HSCT.
1232334|NCT00145626|O1|Outcome|Alive|Group of participants who survived to at least one year post HSCT.
1232335|NCT00145626|O3|Outcome|Study Participants|"Fourteen study participants were evaluable for the outcome measures. Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
1232336|NCT00145626|O2|Outcome|Expired|Those participants who did not survive to at least one year post HSCT.
1232337|NCT00145626|O1|Outcome|Alive|Group of participants who survived to at least one year post HSCT.
1232338|NCT00145626|O3|Outcome|Study Participants|"Fourteen study participants were evaluable for the outcome measures. Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
1232339|NCT00145626|O2|Outcome|Expired|Those participants who did not survive to at least one year post HSCT.
1232340|NCT00145626|O1|Outcome|Alive|Group of participants who survived to at least one year post HSCT.
1232341|NCT00145626|O1|Outcome|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days post-transplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
1232342|NCT00145626|O1|Outcome|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days post-transplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
1232343|NCT00145626|O1|Outcome|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days post-transplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
1232552|NCT00145496|P2|Participant Flow|Olanzapine|5-20 mg by mouth once daily for up to 26 weeks
1232344|NCT00145626|O1|Outcome|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
1232345|NCT00145626|E1|Reported Event|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days post-transplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
1232346|NCT00145600|B5|Baseline|Total|Total of all reporting groups
1232347|NCT00145600|B4|Baseline|Unfavorable Risk, Group 2|"Stage must be classified as one of the following:~a. Ann Arbor stage IIB, IIIB, or any IV"
1232348|NCT00145600|B3|Baseline|Unfavorable Risk, Group 1|Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).
1232349|NCT00145600|B2|Baseline|Intermediate Risk|"Stage must be classified as one of the following:~Ann Arbor stage IB and IIIA~Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)"
1232350|NCT00145600|B1|Baseline|Favorable Risk|"Ann Arbor stage IA or IIA with:~Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x-ray)~< 3 nodal regions involved on the same side of the diaphragm~No extranodal extension of disease"
1232351|NCT00145600|P4|Participant Flow|Unfavorable Risk, Group 2|"Stage must be classified as one of the following:~a. Ann Arbor stage IIB, IIIB, or any IV"
1232352|NCT00145600|P3|Participant Flow|Unfavorable Risk, Group 1|Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).
1232353|NCT00145600|P2|Participant Flow|Intermediate Risk|"Stage must be classified as one of the following:~Ann Arbor stage IB and IIIA~Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)"
1232354|NCT00145600|P1|Participant Flow|Favorable Risk|"Ann Arbor stage IA or IIA with:~Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x-ray)~< 3 nodal regions involved on the same side of the diaphragm~No extranodal extension of disease"
1232355|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
1232356|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
1232357|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
1232358|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
1232359|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
1232360|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
1232361|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
1232362|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
1232363|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
1232364|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
1232365|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
1232366|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
1232367|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
1232368|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
1232369|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
1232370|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
1232371|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
1232372|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
1232373|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
1232374|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
1232375|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
1232376|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
1232379|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
1232380|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
1232381|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
1232382|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
1232383|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
1232384|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
1232385|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
1232386|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
1232387|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
1232388|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
1232389|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
1232390|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
1232391|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
1232392|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
1232393|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
1232394|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
1232395|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
1232396|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
1232397|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
1232398|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
1232399|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
1232400|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
1232401|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
1232402|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
1232403|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
1232404|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
1232405|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
1232406|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
1232407|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
1232408|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
1232409|NCT00145600|O8|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
1232410|NCT00145600|O7|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
1232411|NCT00145600|O6|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
1232412|NCT00145600|O5|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
1232413|NCT00145600|O4|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
1232414|NCT00145600|O3|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
1232415|NCT00145600|O2|Outcome|Parent At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
1232417|NCT00145600|O8|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
1232418|NCT00145600|O7|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
1232419|NCT00145600|O6|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
1232420|NCT00145600|O5|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
1232421|NCT00145600|O4|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
1232422|NCT00145600|O3|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
1232423|NCT00145600|O2|Outcome|Parent At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
1232424|NCT00145600|O1|Outcome|Patient At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
1232425|NCT00145600|O8|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
1232426|NCT00145600|O7|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
1232427|NCT00145600|O6|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
1232428|NCT00145600|O5|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
1232429|NCT00145600|O4|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
1232430|NCT00145600|O3|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
1232431|NCT00145600|O2|Outcome|Parent At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
1232432|NCT00145600|O1|Outcome|Patient At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
1232433|NCT00145600|O8|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
1232434|NCT00145600|O7|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
1232435|NCT00145600|O6|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
1232436|NCT00145600|O5|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
1232437|NCT00145600|O4|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
1232438|NCT00145600|O3|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
1232439|NCT00145600|O2|Outcome|Parent At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
1232440|NCT00145600|O1|Outcome|Patient At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
1232441|NCT00145600|O8|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
1232442|NCT00145600|O7|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
1232443|NCT00145600|O6|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
1232444|NCT00145600|O5|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
1232445|NCT00145600|O4|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
1232446|NCT00145600|O3|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
1232447|NCT00145600|O2|Outcome|Parent At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
1232448|NCT00145600|O1|Outcome|Patient At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
1232449|NCT00145600|O8|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
1232450|NCT00145600|O7|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
1232451|NCT00145600|O6|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
1232452|NCT00145600|O5|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
1232453|NCT00145600|O4|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
1232454|NCT00145600|O3|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
1232455|NCT00145600|O2|Outcome|Parent At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
1232456|NCT00145600|O1|Outcome|Patient At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
1232553|NCT00145496|P1|Participant Flow|Asenapine|5-10 mg sublingually twice daily for up to 26 weeks
1232457|NCT00145600|O4|Outcome|Unfavorable Risk, Group 2|"Stage must be classified as one of the following:~a. Ann Arbor stage IIB, IIIB, or any IV"
1232459|NCT00145600|O2|Outcome|Intermediate Risk|"Stage must be classified as one of the following:~Ann Arbor stage IB and IIIA~Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)"
1232460|NCT00145600|O1|Outcome|Favorable Risk|"Ann Arbor stage IA or IIA with:~Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x-ray)~< 3 nodal regions involved on the same side of the diaphragm~No extranodal extension of disease"
1232461|NCT00145600|E4|Reported Event|Unfavorable Risk, Group 2|"Stage must be classified as one of the following:~a. Ann Arbor stage IIB, IIIB, or any IV"
1232462|NCT00145600|E3|Reported Event|Unfavorable Risk, Group 1|Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).
1232463|NCT00145600|E2|Reported Event|Intermediate Risk|"Stage must be classified as one of the following:~Ann Arbor stage IB and IIIA~Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)"
1232464|NCT00145600|E1|Reported Event|Favorable Risk|"Ann Arbor stage IA or IIA with:~Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x-ray)~< 3 nodal regions involved on the same side of the diaphragm~No extranodal extension of disease"
1232465|NCT00145587|B3|Baseline|Total|Total of all reporting groups
1232466|NCT00145587|B2|Baseline|Sibling|Genetic testing
1232467|NCT00145587|B1|Baseline|Haplo|Patients to receive a haploidentical hematopoietic stem cell transplantation (HSCT).
1232468|NCT00145587|P2|Participant Flow|Sibling|Genetic testing
1232469|NCT00145587|P1|Participant Flow|Haplo|Patients to receive a haploidentical hematopoietic stem cell transplantation (HSCT).
1232470|NCT00145587|O2|Outcome|Sibling|Genetic testing
1232471|NCT00145587|O1|Outcome|Haplo|Patients to receive a haploidentical hematopoietic stem cell transplantation (HSCT).
1232472|NCT00145587|E2|Reported Event|Sibling|Genetic testing
1232473|NCT00145587|E1|Reported Event|Haplo|Patients to receive a haploidentical hematopoietic stem cell transplantation (HSCT).
1232474|NCT00145574|B4|Baseline|Total|Total of all reporting groups
1232475|NCT00145574|B3|Baseline|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
1232476|NCT00145574|B2|Baseline|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
1232477|NCT00145574|B1|Baseline|Placebo|Placebo similar to active
1232478|NCT00145574|P3|Participant Flow|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
1232479|NCT00145574|P2|Participant Flow|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
1232480|NCT00145574|P1|Participant Flow|Placebo|Placebo similar to active
1232481|NCT00145574|O4|Outcome|All High Dose Colesevelam in Open Label Extension|Open Label Extension was an 18 week open-label treatment period. All participants were treated with 3750 mg colesevelam (high-dose).
1232482|NCT00145574|O3|Outcome|High Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period.
1232483|NCT00145574|O2|Outcome|Low Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period.
1232484|NCT00145574|O1|Outcome|Placebo|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period.
1232485|NCT00145574|O4|Outcome|All High Dose Colesevelam in Open Label Extension|Open Label Extension was an 18 week open-label treatment period. All participants were treated with 3750 mg colesevelam (high-dose).
1232486|NCT00145574|O3|Outcome|High Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period.
1232487|NCT00145574|O2|Outcome|Low Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period.
1232488|NCT00145574|O1|Outcome|Placebo|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period.
1232489|NCT00145574|O4|Outcome|All High Dose Colesevelam in Open Label Extension|Open Label Extension was an 18 week open-label treatment period. All participants were treated with 3750 mg colesevelam (high-dose).
1232490|NCT00145574|O3|Outcome|High Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period.
1232491|NCT00145574|O2|Outcome|Low Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period.
1232492|NCT00145574|O1|Outcome|Placebo|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period.
1232493|NCT00145574|O4|Outcome|All High Dose Colesevelam in Open Label Extension|Open Label Extension was an 18 week open-label treatment period. All participants were treated with 3750 mg colesevelam (high-dose).
1232494|NCT00145574|O3|Outcome|High Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period.
1232495|NCT00145574|O2|Outcome|Low Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period.
1247972|NCT00098059|O4|Outcome|13 to <= 18 Years|
1232496|NCT00145574|O1|Outcome|Placebo|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period.
1232759|NCT00144339|O1|Outcome|Placebo|Once daily
1232497|NCT00145574|O4|Outcome|All High Dose Colesevelam in Open Label Extension|Open Label Extension was an 18 week open-label treatment period. All participants were treated with 3750 mg colesevelam (high-dose).
1232498|NCT00145574|O3|Outcome|High Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period.
1232499|NCT00145574|O2|Outcome|Low Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period.
1232500|NCT00145574|O1|Outcome|Placebo|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period.
1232501|NCT00145574|O4|Outcome|All High Dose Colesevelam in Open Label Extension|Open Label Extension was an 18 week open-label treatment period. All participants were treated with 3750 mg colesevelam (high-dose).
1232502|NCT00145574|O3|Outcome|High Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period.
1232503|NCT00145574|O2|Outcome|Low Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period.
1232504|NCT00145574|O1|Outcome|Placebo|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period.
1232505|NCT00145574|O4|Outcome|All High Dose Colesevelam in Open Label Extension|Open Label Extension was an 18 week open-label treatment period. All participants were treated with 3750 mg colesevelam (high-dose).
1232506|NCT00145574|O3|Outcome|High Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period.
1232507|NCT00145574|O2|Outcome|Low Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period.
1232508|NCT00145574|O1|Outcome|Placebo|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period.
1232509|NCT00145574|O3|Outcome|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
1232510|NCT00145574|O2|Outcome|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
1232511|NCT00145574|O1|Outcome|Placebo|Placebo similar to active
1232512|NCT00145574|O3|Outcome|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
1232513|NCT00145574|O2|Outcome|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
1232514|NCT00145574|O1|Outcome|Placebo|Placebo similar to active
1232515|NCT00145574|O3|Outcome|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
1232516|NCT00145574|O2|Outcome|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
1232517|NCT00145574|O1|Outcome|Placebo|Placebo similar to active
1232518|NCT00145574|O3|Outcome|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
1232519|NCT00145574|O2|Outcome|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
1232520|NCT00145574|O1|Outcome|Placebo|Placebo similar to active
1232521|NCT00145574|O3|Outcome|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
1232522|NCT00145574|O2|Outcome|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
1232523|NCT00145574|O1|Outcome|Placebo|Placebo similar to active
1232524|NCT00145574|O3|Outcome|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
1232525|NCT00145574|O2|Outcome|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
1232526|NCT00145574|O1|Outcome|Placebo|Placebo similar to active
1232527|NCT00145574|O3|Outcome|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
1232528|NCT00145574|O2|Outcome|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
1232529|NCT00145574|O1|Outcome|Placebo|Placebo similar to active
1232530|NCT00145574|E4|Reported Event|High Dose Colesevelam Open Label Extension|All participants of the Open Label Extension (weeks 8-26) took colesevelam 3.8 grams per day.
1232531|NCT00145574|E3|Reported Event|High Dose Colesevelam Double Blind Period|High dose colesevelam 3.8 grams per day taken from day 1 to week 8.
1232532|NCT00145574|E2|Reported Event|Low Dose Colesevelam Double Blind Period|Low dose colesevelam 1.9 grams per day taken from day 1 to week 8.
1232533|NCT00145574|E1|Reported Event|Placebo Double Blind Period|Placebo taken from day 1 to week 8.
1232534|NCT00145509|B3|Baseline|Total|Total of all reporting groups
1232535|NCT00145509|B2|Baseline|Placebo|Placebo sublingually BID
1232536|NCT00145509|B1|Baseline|Asenapine|Asenapine 5 or 10 mg sublingually twice daily (BID)
1232537|NCT00145509|P2|Participant Flow|Placebo|Placebo sublingually BID
1232538|NCT00145509|P1|Participant Flow|Asenapine|Asenapine 5 or 10 mg sublingually twice daily (BID)
1232539|NCT00145509|O2|Outcome|Placebo|Placebo sublingually BID
1232540|NCT00145509|O1|Outcome|Asenapine|Asenapine 5 or 10 mg sublingually twice daily (BID)
1232541|NCT00145509|O2|Outcome|Placebo|Placebo sublingually BID
1232542|NCT00145509|O1|Outcome|Asenapine|Asenapine 5 or 10 mg sublingually twice daily (BID)
1232543|NCT00145509|O2|Outcome|Placebo|Placebo sublingually BID
1232544|NCT00145509|O1|Outcome|Asenapine|Asenapine 5 or 10 mg sublingually twice daily (BID)
1232545|NCT00145509|O2|Outcome|Placebo|Placebo sublingually BID
1232546|NCT00145509|O1|Outcome|Asenapine|Asenapine 5 or 10 mg sublingually twice daily (BID)
1232547|NCT00145509|E2|Reported Event|Placebo|Placebo sublingually BID
1232548|NCT00145509|E1|Reported Event|Asenapine|Asenapine 5 or 10 mg sublingually twice daily (BID)
1232560|NCT00145496|E2|Reported Event|Olanzapine|5-20 mg by mouth once daily for up to 26 weeks
1232561|NCT00145496|E1|Reported Event|Asenapine|5-10 mg sublingually twice daily for up to 26 weeks
1232562|NCT00145418|B1|Baseline|Oxaliplatin + Docetaxel|Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
1232563|NCT00145418|P1|Participant Flow|Oxaliplatin + Docetaxel|Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer. Oxaliplatin:85 mg/m2 on Days 1 and 15 every 28 days Docetaxel:30 mg/m2 on Days 1 and 8 every 28 days.Doses will be calculated using actual body weight unless in the investigators opinion it would be in the patient's best interest to use ideal body weight. Cycles will be repeated every 28 days for a maximum of 6 cycles.
1232564|NCT00145418|O1|Outcome|Oxaliplatin + Docetaxel|Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
1232565|NCT00145418|O1|Outcome|Oxaliplatin + Docetaxel|Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
1232566|NCT00145418|O1|Outcome|Oxaliplatin + Docetaxel|Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
1232567|NCT00145418|O1|Outcome|Oxaliplatin + Docetaxel|Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
1232568|NCT00145418|E1|Reported Event|Oxaliplatin + Docetaxel|Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
1232569|NCT00145327|B4|Baseline|Total|Total of all reporting groups
1232570|NCT00145327|B3|Baseline|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
1232571|NCT00145327|B2|Baseline|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
1232572|NCT00145327|B1|Baseline|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
1232573|NCT00145327|P3|Participant Flow|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
1232574|NCT00145327|P2|Participant Flow|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
1232575|NCT00145327|P1|Participant Flow|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
1232576|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
1232577|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
1232578|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
1232579|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
1232580|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
1232581|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
1232582|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
1232583|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
1232584|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
1232585|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
1232586|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
1232587|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
1232588|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
1232750|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232751|NCT00144339|O1|Outcome|Placebo|Once daily
1232589|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
1232590|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
1232591|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
1232592|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
1232593|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
1232594|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
1232595|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
1232596|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
1232597|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
1232598|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
1232599|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
1232600|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
1232601|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
1232602|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
1232603|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
1232604|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
1232605|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
1232606|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
1232607|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
1232608|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
1232609|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
1232610|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
1232611|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
1232612|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
1232613|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
1232614|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
1232615|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
1232616|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
1232617|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
1232618|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
1232619|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
1232620|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
1232621|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
1232622|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
1232623|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
1232624|NCT00145327|E3|Reported Event|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
1232625|NCT00145327|E2|Reported Event|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
1232626|NCT00145327|E1|Reported Event|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
1232627|NCT00145249|B4|Baseline|Total|Total of all reporting groups
1232628|NCT00145249|B3|Baseline|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
1232629|NCT00145249|B2|Baseline|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
1232630|NCT00145249|B1|Baseline|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
1232631|NCT00145249|P3|Participant Flow|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
1232632|NCT00145249|P2|Participant Flow|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
1232633|NCT00145249|P1|Participant Flow|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
1232634|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
1232635|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
1232636|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
1232637|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
1232638|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
1232639|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
1232640|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
1232641|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
1232642|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
1232643|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
1232644|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
1232645|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
1232646|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
1232647|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
1232648|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
1232649|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
1232650|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
1232651|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
1232652|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
1232653|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
1232654|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
1232655|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
1232656|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
1232657|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
1232658|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
1232659|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
1232660|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
1232661|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
1232662|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
1232663|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
1232664|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
1232665|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
1232666|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
1232667|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
1232668|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
1232669|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
1232670|NCT00145249|E3|Reported Event|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
1232752|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232753|NCT00144339|O1|Outcome|Placebo|Once daily
1232671|NCT00145249|E2|Reported Event|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
1232672|NCT00145249|E1|Reported Event|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
1232673|NCT00145119|B1|Baseline|Patients|Survivors of an acute Myocardial Infarction (AMI) with impaired left ventricular ejection fraction
1232674|NCT00145119|P1|Participant Flow|Patients|
1232675|NCT00145119|O1|Outcome|Patients|Survivors of an acute Myocardial Infarction (AMI) with impaired left ventricular ejection fraction
1232676|NCT00145119|E1|Reported Event|Patients|Survivors of an acute Myocardial Infarction (AMI) with impaired left ventricular ejection fraction.
1232677|NCT00144339|B3|Baseline|Total|Total of all reporting groups
1232678|NCT00144339|B2|Baseline|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232679|NCT00144339|B1|Baseline|Placebo|Once daily
1232680|NCT00144339|P2|Participant Flow|Tiotropium Bromide Inhalation Capsules 18 mcg|once daily
1232681|NCT00144339|P1|Participant Flow|Placebo|once daily
1232682|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232683|NCT00144339|O1|Outcome|Placebo|Once daily
1232684|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232685|NCT00144339|O1|Outcome|Placebo|Once daily
1232686|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232687|NCT00144339|O1|Outcome|Placebo|Once daily
1232688|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232689|NCT00144339|O1|Outcome|Placebo|Once daily
1232690|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232691|NCT00144339|O1|Outcome|Placebo|Once daily
1232692|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232693|NCT00144339|O1|Outcome|Placebo|Once daily
1232694|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232695|NCT00144339|O1|Outcome|Placebo|Once daily
1232696|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232697|NCT00144339|O1|Outcome|Placebo|Once daily
1232698|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232699|NCT00144339|O1|Outcome|Placebo|Once daily
1232700|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232701|NCT00144339|O1|Outcome|Placebo|Once daily
1232702|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232703|NCT00144339|O1|Outcome|Placebo|Once daily
1232704|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232705|NCT00144339|O1|Outcome|Placebo|Once daily
1232706|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232707|NCT00144339|O1|Outcome|Placebo|Once daily
1232708|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232709|NCT00144339|O1|Outcome|Placebo|Once daily
1232710|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232711|NCT00144339|O1|Outcome|Placebo|Once daily
1232712|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232713|NCT00144339|O1|Outcome|Placebo|Once daily
1232714|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232715|NCT00144339|O1|Outcome|Placebo|Once daily
1232716|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232717|NCT00144339|O1|Outcome|Placebo|Once daily
1232718|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232719|NCT00144339|O1|Outcome|Placebo|Once daily
1232720|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232721|NCT00144339|O1|Outcome|Placebo|Once daily
1232722|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232723|NCT00144339|O1|Outcome|Placebo|Once daily
1232724|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232725|NCT00144339|O1|Outcome|Placebo|Once daily
1232726|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232727|NCT00144339|O1|Outcome|Placebo|Once daily
1232728|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232729|NCT00144339|O1|Outcome|Placebo|Once daily
1232730|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232731|NCT00144339|O1|Outcome|Placebo|Once daily
1232732|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232733|NCT00144339|O1|Outcome|Placebo|Once daily
1232734|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232735|NCT00144339|O1|Outcome|Placebo|Once daily
1232736|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232737|NCT00144339|O1|Outcome|Placebo|Once daily
1232738|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232739|NCT00144339|O1|Outcome|Placebo|Once daily
1232740|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232741|NCT00144339|O1|Outcome|Placebo|Once daily
1232742|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232743|NCT00144339|O1|Outcome|Placebo|Once daily
1232744|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232745|NCT00144339|O1|Outcome|Placebo|Once daily
1232746|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232747|NCT00144339|O1|Outcome|Placebo|Once daily
1232748|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232754|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232755|NCT00144339|O1|Outcome|Placebo|Once daily
1232756|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232760|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232761|NCT00144339|O1|Outcome|Placebo|Once daily
1232762|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232763|NCT00144339|O1|Outcome|Placebo|Once daily
1232764|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232765|NCT00144339|O1|Outcome|Placebo|Once daily
1232766|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232767|NCT00144339|O1|Outcome|Placebo|Once daily
1232768|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232769|NCT00144339|O1|Outcome|Placebo|Once daily
1232770|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232771|NCT00144339|O1|Outcome|Placebo|Once daily
1232772|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232773|NCT00144339|O1|Outcome|Placebo|Once daily
1232774|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232775|NCT00144339|O1|Outcome|Placebo|Once daily
1232776|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232777|NCT00144339|O1|Outcome|Placebo|Once daily
1232778|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232779|NCT00144339|O1|Outcome|Placebo|Once daily
1232780|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232781|NCT00144339|O1|Outcome|Placebo|Once daily
1232782|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232783|NCT00144339|O1|Outcome|Placebo|Once daily
1232784|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232785|NCT00144339|O1|Outcome|Placebo|Once daily
1232786|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232787|NCT00144339|O1|Outcome|Placebo|Once daily
1232788|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232789|NCT00144339|O1|Outcome|Placebo|Once daily
1232790|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232791|NCT00144339|O1|Outcome|Placebo|Once daily
1232792|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232793|NCT00144339|O1|Outcome|Placebo|Once daily
1232794|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232795|NCT00144339|O1|Outcome|Placebo|Once daily
1232796|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232797|NCT00144339|O1|Outcome|Placebo|Once daily
1232798|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232799|NCT00144339|O1|Outcome|Placebo|Once daily
1232800|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232801|NCT00144339|O1|Outcome|Placebo|Once daily
1232802|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232803|NCT00144339|O1|Outcome|Placebo|Once daily
1232804|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232805|NCT00144339|O1|Outcome|Placebo|Once daily
1232806|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232807|NCT00144339|O1|Outcome|Placebo|Once daily
1232808|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232809|NCT00144339|O1|Outcome|Placebo|Once daily
1232810|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232811|NCT00144339|O1|Outcome|Placebo|Once daily
1232812|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232813|NCT00144339|O1|Outcome|Placebo|Once daily
1232814|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232815|NCT00144339|O1|Outcome|Placebo|Once daily
1232816|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232817|NCT00144339|O1|Outcome|Placebo|Once daily
1232818|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232819|NCT00144339|O1|Outcome|Placebo|Once daily
1232820|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232821|NCT00144339|O1|Outcome|Placebo|Once daily
1232822|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232823|NCT00144339|O1|Outcome|Placebo|Once daily
1232824|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232825|NCT00144339|O1|Outcome|Placebo|Once daily
1232826|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232827|NCT00144339|O1|Outcome|Placebo|Once daily
1232828|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232829|NCT00144339|O1|Outcome|Placebo|Once daily
1232830|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232831|NCT00144339|O1|Outcome|Placebo|Once daily
1232832|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232833|NCT00144339|O1|Outcome|Placebo|Once daily
1232834|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232835|NCT00144339|O1|Outcome|Placebo|Once daily
1232836|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232837|NCT00144339|O1|Outcome|Placebo|Once daily
1247973|NCT00098059|O3|Outcome|6 to <=12 Years|
1232838|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232839|NCT00144339|O1|Outcome|Placebo|Once daily
1232840|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232841|NCT00144339|O1|Outcome|Placebo|Once daily
1232842|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232843|NCT00144339|O1|Outcome|Placebo|Once daily
1232844|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232845|NCT00144339|O1|Outcome|Placebo|Once daily
1232846|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232847|NCT00144339|O1|Outcome|Placebo|Once daily
1232848|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232849|NCT00144339|O1|Outcome|Placebo|Once daily
1232850|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232851|NCT00144339|O1|Outcome|Placebo|Once daily
1232852|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232853|NCT00144339|O1|Outcome|Placebo|Once daily
1232854|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232855|NCT00144339|O1|Outcome|Placebo|Once daily
1232856|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232857|NCT00144339|O1|Outcome|Placebo|Once daily
1232858|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232859|NCT00144339|O1|Outcome|Placebo|Once daily
1232860|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232861|NCT00144339|O1|Outcome|Placebo|Once daily
1232862|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232863|NCT00144339|O1|Outcome|Placebo|Once daily
1232864|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232865|NCT00144339|O1|Outcome|Placebo|Once daily
1232866|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232867|NCT00144339|O1|Outcome|Placebo|Once daily
1232868|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232869|NCT00144339|O1|Outcome|Placebo|Once daily
1232870|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232871|NCT00144339|O1|Outcome|Placebo|Once daily
1232872|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232873|NCT00144339|O1|Outcome|Placebo|Once daily
1232874|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232875|NCT00144339|O1|Outcome|Placebo|Once daily
1232876|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232877|NCT00144339|O1|Outcome|Placebo|Once daily
1232878|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232879|NCT00144339|O1|Outcome|Placebo|Once daily
1232880|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232881|NCT00144339|O1|Outcome|Placebo|Once daily
1232882|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232883|NCT00144339|O1|Outcome|Placebo|Once daily
1232884|NCT00144339|E2|Reported Event|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
1232885|NCT00144339|E1|Reported Event|Placebo|Once daily
1232886|NCT00144300|B3|Baseline|Total|Total of all reporting groups
1232887|NCT00144300|B2|Baseline|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
1232888|NCT00144300|B1|Baseline|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
1232889|NCT00144300|P2|Participant Flow|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
1232890|NCT00144300|P1|Participant Flow|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
1232891|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
1232892|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
1232893|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
1232894|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
1232895|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
1232896|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
1232897|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
1232898|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
1232899|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
1232900|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
1232901|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
1232902|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
1232903|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
1232904|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
1232905|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
1232906|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
1232907|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
1232908|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
1232909|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
1232910|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
1232911|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
1232912|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
1232913|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
1232914|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
1232915|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
1232916|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
1232917|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
1232918|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
1232919|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
1232920|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
1232921|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
1232922|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
1232923|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
1232924|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
1232925|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
1232926|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
1232927|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
1232928|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
1232929|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
1232930|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
1232931|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
1232932|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
1232933|NCT00144300|E2|Reported Event|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
1232934|NCT00144300|E1|Reported Event|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
1232935|NCT00145041|B1|Baseline|Overall Study|This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
1232936|NCT00145041|P1|Participant Flow|Overall Study|This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
1232937|NCT00145041|O1|Outcome|Overall Study|This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
1232938|NCT00145041|O1|Outcome|Overall Study|This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
1232939|NCT00145041|O1|Outcome|Overall Study|This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
1232940|NCT00145041|E1|Reported Event|Overall Study|This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
1232941|NCT00144963|B1|Baseline|VSLI|Vincristine Sulfate Liposomes Injection (VSLI)
1232942|NCT00144963|P1|Participant Flow|VSLI|Vincristine Sulfate Liposomes Injection (VSLI)
1232943|NCT00144963|O1|Outcome|VSLI|Vincristine Sulfate Liposomes Injection (VSLI)
1232944|NCT00144963|E1|Reported Event|VSLI|Vincristine Sulfate Liposomes Injection (VSLI)
1232945|NCT00144781|B5|Baseline|Total|Total of all reporting groups
1232946|NCT00144781|B4|Baseline|1.8 mg/kg Aldurazyme Every 2 Weeks|1.8 mg Aldurazyme/kg of body weight (300 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
1232947|NCT00144781|B3|Baseline|1.2 mg/kg Aldurazyme Every 2 Weeks|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
1232948|NCT00144781|B2|Baseline|1.2 mg/kg Aldurazyme Every Week|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every week. Final Visit is Week 27 for patients randomized to every week regimen.
1232949|NCT00144781|B1|Baseline|0.58 mg/kg Aldurazyme Every Week|0.58 mg Aldurazyme/kg of body weight (100 U/kg) administered every week (labeled dose). Final Visit is Week 27 for patients randomized to every week regimen.
1232950|NCT00144781|P4|Participant Flow|1.8 mg/kg Aldurazyme Every 2 Weeks|1.8 mg Aldurazyme/kg of body weight (300 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
1232951|NCT00144781|P3|Participant Flow|1.2 mg/kg Aldurazyme Every 2 Weeks|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
1232952|NCT00144781|P2|Participant Flow|1.2 mg/kg Aldurazyme Every Week|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every week. Final Visit is Week 27 for patients randomized to every week regimen.
1232953|NCT00144781|P1|Participant Flow|0.58 mg/kg Aldurazyme Every Week|0.58 mg Aldurazyme/kg of body weight (100 U/kg) administered every week (labeled dose). Final Visit is Week 27 for patients randomized to every week regimen.
1232954|NCT00144781|O4|Outcome|1.8 mg/kg Aldurazyme Every 2 Weeks|1.8 mg Aldurazyme/kg of body weight (300 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
1232955|NCT00144781|O3|Outcome|1.2 mg/kg Aldurazyme Every 2 Weeks|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
1232956|NCT00144781|O2|Outcome|1.2 mg/kg Aldurazyme Every Week|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every week. Final Visit is Week 27 for patients randomized to every week regimen.
1232957|NCT00144781|O1|Outcome|0.58 mg/kg Aldurazyme Every Week|0.58 mg Aldurazyme/kg of body weight (100 U/kg) administered every week (labeled dose). Final Visit is Week 27 for patients randomized to every week regimen.
1233021|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1232958|NCT00144781|O4|Outcome|1.8 mg/kg Aldurazyme Every 2 Weeks|1.8 mg Aldurazyme/kg of body weight (300 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
1232959|NCT00144781|O3|Outcome|1.2 mg/kg Aldurazyme Every 2 Weeks|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
1233027|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1232960|NCT00144781|O2|Outcome|1.2 mg/kg Aldurazyme Every Week|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every week. Final Visit is Week 27 for patients randomized to every week regimen.
1232961|NCT00144781|O1|Outcome|0.58 mg/kg Aldurazyme Every Week|0.58 mg Aldurazyme/kg of body weight (100 U/kg) administered every week (labeled dose). Final Visit is Week 27 for patients randomized to every week regimen.
1232962|NCT00144781|O4|Outcome|1.8 mg/kg Aldurazyme Every 2 Weeks|1.8 mg Aldurazyme/kg of body weight (300 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
1232963|NCT00144781|O3|Outcome|1.2 mg/kg Aldurazyme Every 2 Weeks|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
1232964|NCT00144781|O2|Outcome|1.2 mg/kg Aldurazyme Every Week|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every week. Final Visit is Week 27 for patients randomized to every week regimen.
1232965|NCT00144781|O1|Outcome|0.58 mg/kg Aldurazyme Every Week|0.58 mg Aldurazyme/kg of body weight (100 U/kg) administered every week (labeled dose). Final Visit is Week 27 for patients randomized to every week regimen.
1232966|NCT00144781|E4|Reported Event|"Aldurazyme|Weekly|1.2 mg/kg***Check Title***"|"Aldurazyme|Weekly|1.2 mg/kg***Check Description***"
1232967|NCT00144781|E3|Reported Event|"Aldurazyme|Weekly|0.58 mg/kg***Check Title***"|"Aldurazyme|Weekly|0.58 mg/kg***Check Description***"
1232968|NCT00144781|E2|Reported Event|"Aldurazyme|Every Other|Week 1.8 mg/kg***Check Title***"|"Aldurazyme|Every Other|Week 1.8 mg/kg***Check Description***"
1232969|NCT00144781|E1|Reported Event|"Aldurazyme|Every Other|Week 1.2 mg/kg***Check Title***"|"Aldurazyme|Every Other|Week 1.2 mg/kg***Check Description***"
1232970|NCT00144170|B3|Baseline|Total|Total of all reporting groups
1232971|NCT00144170|B2|Baseline|Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1232972|NCT00144170|B1|Baseline|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1232973|NCT00144170|P2|Participant Flow|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1232974|NCT00144170|P1|Participant Flow|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1232975|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1232976|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1232977|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1232978|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1232979|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1232980|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1232981|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1232982|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1232983|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1232984|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1232985|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1232986|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1232987|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1232988|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1232989|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1232990|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1232991|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1232992|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1232993|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1232994|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1232995|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1232996|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1232997|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1232998|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1232999|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233000|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233001|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233002|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233003|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233004|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233005|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233006|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233007|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233008|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233009|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233010|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233011|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233012|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233013|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233014|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233015|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233016|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233017|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233018|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233019|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233020|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233023|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233024|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233025|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233026|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233029|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233030|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233031|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233032|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233033|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233034|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233035|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233036|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233037|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233038|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233039|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233040|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233041|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233042|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233043|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233044|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233045|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233046|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233047|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233048|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233049|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233050|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233051|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233052|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233053|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233054|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233055|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233056|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233057|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233058|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233059|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233060|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233061|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233062|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233063|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233064|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233065|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233066|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233067|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233068|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233069|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233070|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233071|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233072|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233073|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233074|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233075|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233076|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233077|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233078|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233079|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233080|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233081|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233082|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233083|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233084|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233085|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233086|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233087|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233088|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233089|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233090|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233091|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233092|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233093|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233094|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233095|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233096|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233097|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233099|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233100|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233101|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233102|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233103|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233104|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233105|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233106|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233107|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233108|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233109|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233110|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233111|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233112|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233113|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233114|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233115|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233116|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233117|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233118|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233119|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233120|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233121|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233122|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233123|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233124|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233125|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233126|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233127|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233128|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233129|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233130|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233131|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233132|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233133|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233134|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233135|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233136|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233137|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233138|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233139|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233140|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233141|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233142|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233143|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233144|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233145|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233146|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233147|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233148|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233149|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233150|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233151|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233152|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233153|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233154|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233155|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233156|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233157|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233158|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233159|NCT00144170|E2|Reported Event|Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
1233160|NCT00144170|E1|Reported Event|Tipranavir(TPV)/Low Dose Ritonavir(r)|
1233161|NCT00144027|B3|Baseline|Total|Total of all reporting groups
1233162|NCT00144027|B2|Baseline|Intervention Group|Antipsychotic medication adherence intervention: The medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits. The patient will receive a hard copy summary of their responses (top 3 barriers and top 3 facilitators and motivators) with brief adherence tips which are specific to the patient-selected barriers. The provider will received the same information in an electronic health record adherence note.
1233163|NCT00144027|B1|Baseline|Control/No Intervention|The control group will receive treatment as usual; meaning patients in the control group will not receive the medication adherence intervention.
1233187|NCT00143819|O2|Outcome|Placebo Spray (Psoriasis Patients)|"bilateral comparison~Subjects were randomized to apply placebo spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks."
1233188|NCT00143819|O1|Outcome|Neuroskin Forte Spray (Psoriasis Patients)|"bilateral comparison~Subjects were randomized to apply Neuroskin Forte study drug spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks."
1233164|NCT00144027|P2|Participant Flow|Antipsychotic Adherence Intervention Group|Antipsychotic medication adherence intervention: The medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits. The patient will receive a hard copy summary of their responses (top 3 barriers and top 3 facilitators and motivators) with brief adherence tips which are specific to the patient-selected barriers. The provider will received the same information in an electronic health record adherence note.
1233165|NCT00144027|P1|Participant Flow|Control|The control group will receive treatment as usual; meaning patients in the control group will not receive the medication adherence intervention.
1233166|NCT00144027|O2|Outcome|Intervention Group|Antipsychotic medication adherence intervention: The medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits. The patient will receive a hard copy summary of their responses (top 3 barriers and top 3 facilitators and motivators) with brief adherence tips which are specific to the patient-selected barriers. The provider will received the same information in an electronic health record adherence note.
1233167|NCT00144027|O1|Outcome|Control/No Intervention|The control group will receive treatment as usual; meaning patients in the control group will not receive the medication adherence intervention.
1233168|NCT00144027|E2|Reported Event|Intervention Group|Antipsychotic medication adherence intervention: The medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits. The patient will receive a hard copy summary of their responses (top 3 barriers and top 3 facilitators and motivators) with brief adherence tips which are specific to the patient-selected barriers. The provider will received the same information in an electronic health record adherence note.
1233169|NCT00144027|E1|Reported Event|Control/No Intervention|The control group will receive treatment as usual; meaning patients in the control group will not receive the medication adherence intervention.
1233170|NCT00143845|B1|Baseline|Immunosuppression Taper|Reduced intensity conditioning consisting of Busulfan and Fludarabine(fludarabine 150 mg/m2 IV, busulfan 6 mg/kg IV, total lymphoid irradiation 2 Gy), followed by a rapid immunosuppressive taper of Tacrolimus (0.06 mg/kg q12h, PO, Days -7 to +28), Methotrexate (5 mg/m2, IV, Days +1, +3, +6, +11) and Mycophenolate Mofetil (10 mg/kg every 8 hours, PO, Days -6 to +7).
1233171|NCT00143845|P1|Participant Flow|Immunosuppression Taper|Reduced intensity conditioning consisting of Busulfan and Fludarabine(fludarabine 150 mg/m2 IV, busulfan 6 mg/kg IV, total lymphoid irradiation 2 Gy), followed by a rapid immunosuppressive taper of Tacrolimus (0.06 mg/kg q12h, PO, Days -7 to +28), Methotrexate (5 mg/m2, IV, Days +1, +3, +6, +11) and Mycophenolate Mofetil (10 mg/kg every 8 hours, PO, Days -6 to +7).
1233172|NCT00143845|O1|Outcome|Immunosuppression Taper|Reduced intensity conditioning consisting of Busulfan and Fludarabine(fludarabine 150 mg/m2 IV, busulfan 6 mg/kg IV, total lymphoid irradiation 2 Gy), followed by a rapid immunosuppressive taper of Tacrolimus (0.06 mg/kg q12h, PO, Days -7 to +28), Methotrexate (5 mg/m2, IV, Days +1, +3, +6, +11) and Mycophenolate Mofetil (10 mg/kg every 8 hours, PO, Days -6 to +7).
1233173|NCT00143845|O1|Outcome|Immunosuppression Taper|Reduced intensity conditioning consisting of Busulfan and Fludarabine(fludarabine 150 mg/m2 IV, busulfan 6 mg/kg IV, total lymphoid irradiation 2 Gy), followed by a rapid immunosuppressive taper of Tacrolimus (0.06 mg/kg q12h, PO, Days -7 to +28), Methotrexate (5 mg/m2, IV, Days +1, +3, +6, +11) and Mycophenolate Mofetil (10 mg/kg every 8 hours, PO, Days -6 to +7).
1233174|NCT00143845|O1|Outcome|Immunosuppression Taper|Reduced intensity conditioning consisting of Busulfan and Fludarabine(fludarabine 150 mg/m2 IV, busulfan 6 mg/kg IV, total lymphoid irradiation 2 Gy), followed by a rapid immunosuppressive taper of Tacrolimus (0.06 mg/kg q12h, PO, Days -7 to +28), Methotrexate (5 mg/m2, IV, Days +1, +3, +6, +11) and Mycophenolate Mofetil (10 mg/kg every 8 hours, PO, Days -6 to +7).
1233175|NCT00143845|E1|Reported Event|Immunosuppression Taper|Reduced intensity conditioning consisting of Busulfan and Fludarabine(fludarabine 150 mg/m2 IV, busulfan 6 mg/kg IV, total lymphoid irradiation 2 Gy), followed by a rapid immunosuppressive taper of Tacrolimus (0.06 mg/kg q12h, PO, Days -7 to +28), Methotrexate (5 mg/m2, IV, Days +1, +3, +6, +11) and Mycophenolate Mofetil (10 mg/kg every 8 hours, PO, Days -6 to +7).
1233176|NCT00143819|B3|Baseline|Total|Total of all reporting groups
1233177|NCT00143819|B2|Baseline|Bilateral Comparison Group 2|"bilateral comparison~Placebo Application: Subjects will apply placebo sprays 3 times a day (with optional 4th application) to the assigned, randomized sides of the body for 8 weeks"
1233178|NCT00143819|B1|Baseline|Bilateral Comparison Group 1|"bilateral comparison~Neuroskin Forte: Subjects will apply study drug sprays 3 times a day (with optional 4th application) to the assigned, randomized sides of the body for 8 weeks"
1233179|NCT00143819|P2|Participant Flow|2 (Left Side: Placebo; Right Side: Active)|"bilateral comparison~Subjects randomized to Group 2 applied placebo sprays to the left side of the body and Neuroskin Forte study drug sprays to the right side of the body, 3 times a day (with optional 4th application), for 8 weeks."
1233180|NCT00143819|P1|Participant Flow|1 (Left Side: Active; Right Side: Placebo)|"bilateral comparison~Subjects randomized to Group 1 applied Neuroskin Forte study drug sprays to the left side of the body and placebo sprays to the right side of the body, 3 times a day (with optional 4th application), for 8 weeks."
1233181|NCT00143819|O2|Outcome|Placebo Spray|"bilateral comparison~Subjects were randomized to apply placebo spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks."
1233182|NCT00143819|O1|Outcome|Neuroskin Forte Spray|"bilateral comparison~Subjects were randomized to apply Neuroskin Forte study drug spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks."
1233183|NCT00143819|O2|Outcome|Placebo Spray|"bilateral comparison~Subjects were randomized to apply placebo spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks."
1233184|NCT00143819|O1|Outcome|Neuroskin Forte Spray|"bilateral comparison~Subjects were randomized to apply Neuroskin Forte study drug spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks."
1233185|NCT00143819|O2|Outcome|Placebo Spray (Eczema Patients)|"bilateral comparison~Subjects were randomized to apply placebo spray to one side of the body, 3 times a day (with optional 4th application), for 8 weeks."
1233186|NCT00143819|O1|Outcome|Neuroskin Forte Spray (Eczema Patients)|"bilateral comparison~Subjects were randomized to apply Neuroskin Forte study drug spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks."
1233189|NCT00143819|O2|Outcome|Placebo Spray|"bilateral comparison~Subjects were randomized to apply placebo spray to one side of the body, 3 times a day (with optional 4th application), for 8 weeks."
1233190|NCT00143819|O1|Outcome|Neuroskin Forte Spray|"bilateral comparison~Subjects were randomized to apply Neuroskin Forte study drug spray to one side of the body 3 times a day (with optional 4th application), for 8 weeks."
1233545|NCT00141817|O4|Outcome|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
1233191|NCT00143819|E1|Reported Event|Bilateral Comparison: Neuroskin Forte Spray vs Placebo Spray|"bilateral comparison~Subjects were randomized to apply Neuroskin Forte study drug spray to one side of the body and placebo spray to the other side of the body, 3 times a day (with optional 4th application), for 8 weeks."
1233192|NCT00143598|B3|Baseline|Total|Total of all reporting groups
1233193|NCT00143598|B2|Baseline|Placebo ECS|Placebo stockings with identical appearance but less than 5 mm Hg compression at the ankle.
1233194|NCT00143598|B1|Baseline|Active ECS|Active Elastic Compression Stockings. 30-40 mm Hg
1233195|NCT00143598|P2|Participant Flow|Placebo ECS|Placebo stockings with identical appearance but less than 5 mm Hg compression at the ankle.
1233196|NCT00143598|P1|Participant Flow|Active ECS|Active Elastic Compression Stockings. 30-40 mm Hg
1233197|NCT00143598|O2|Outcome|Placebo ECS|Placebo stockings with identical appearance to Active ECS and with < 5 mm Hg compression at the ankle.
1233198|NCT00143598|O1|Outcome|Active ECS|Active Elastic Compression Stockings (ECS) 30-40 mm Hg compression at the ankle.
1233199|NCT00143598|O2|Outcome|Placebo ECS|Placebo stockings with identical appearance to Active ECS and with < 5 mm Hg compression at the ankle.
1233200|NCT00143598|O1|Outcome|Active ECS|Active Elastic Compression Stockings (ECS) 30-40 mm Hg compression at the ankle.
1233201|NCT00143598|O2|Outcome|Placebo ECS|Placebo stockings with identical appearance to Active ECS and with < 5 mm Hg compression at the ankle.
1233202|NCT00143598|O1|Outcome|Active ECS|Active Elastic Compression Stockings (ECS) 30-40 mm Hg compression at the ankle.
1233203|NCT00143598|O2|Outcome|Placebo ECS|Placebo stockings with identical appearance to Active ECS and with < 5 mm Hg compression at the ankle.
1233204|NCT00143598|O1|Outcome|Active ECS|Active Elastic Compression Stockings (ECS) 30-40 mm Hg compression at the ankle.
1233205|NCT00143598|E2|Reported Event|Placebo ECS|Placebo stockings with identical appearance to Active ECS and with < 5 mm Hg compression at the ankle.
1233206|NCT00143598|E1|Reported Event|Active ECS|Active Elastic Compression Stockings (ECS) 30-40 mm Hg compression at the ankle.
1233207|NCT00143507|B3|Baseline|Total|Total of all reporting groups
1233208|NCT00143507|B2|Baseline|Placebo|Patients received placebo twice daily.
1233209|NCT00143507|B1|Baseline|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
1233210|NCT00143507|P2|Participant Flow|Placebo|Patients received placebo twice daily.
1233211|NCT00143507|P1|Participant Flow|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
1233212|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
1233213|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
1233214|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
1233215|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
1233216|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
1233217|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
1233218|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
1233219|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
1233220|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
1233221|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
1233222|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
1233223|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
1233224|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
1233225|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
1233226|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
1233227|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
1233228|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
1233229|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
1233230|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
1233231|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
1233232|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
1233233|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
1233234|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
1247974|NCT00098059|O2|Outcome|2 to <6 Years|
1233235|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
1233236|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
1233546|NCT00141817|O3|Outcome|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
1233237|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
1233238|NCT00143507|E2|Reported Event|Placebo|Patients received placebo twice daily.
1233239|NCT00143507|E1|Reported Event|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
1233240|NCT00143455|B5|Baseline|Total|Total of all reporting groups
1233241|NCT00143455|B4|Baseline|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233242|NCT00143455|B3|Baseline|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233243|NCT00143455|B2|Baseline|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233244|NCT00143455|B1|Baseline|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233245|NCT00143455|P4|Participant Flow|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233246|NCT00143455|P3|Participant Flow|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233247|NCT00143455|P2|Participant Flow|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233248|NCT00143455|P1|Participant Flow|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233249|NCT00143455|O4|Outcome|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233250|NCT00143455|O3|Outcome|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233251|NCT00143455|O2|Outcome|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233252|NCT00143455|O1|Outcome|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233253|NCT00143455|O4|Outcome|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233254|NCT00143455|O3|Outcome|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233255|NCT00143455|O2|Outcome|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233256|NCT00143455|O1|Outcome|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233257|NCT00143455|O4|Outcome|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233258|NCT00143455|O3|Outcome|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233259|NCT00143455|O2|Outcome|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233566|NCT00141778|B3|Baseline|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
1233260|NCT00143455|O1|Outcome|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233261|NCT00143455|O4|Outcome|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233262|NCT00143455|O3|Outcome|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233263|NCT00143455|O2|Outcome|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233264|NCT00143455|O1|Outcome|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233265|NCT00143455|O2|Outcome|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233266|NCT00143455|O1|Outcome|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233267|NCT00143455|O4|Outcome|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233268|NCT00143455|O3|Outcome|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233269|NCT00143455|O2|Outcome|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233270|NCT00143455|O1|Outcome|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233271|NCT00143455|O4|Outcome|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233272|NCT00143455|O3|Outcome|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233273|NCT00143455|O2|Outcome|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233274|NCT00143455|O1|Outcome|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233275|NCT00143455|E4|Reported Event|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233276|NCT00143455|E3|Reported Event|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233277|NCT00143455|E2|Reported Event|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233278|NCT00143455|E1|Reported Event|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
1233279|NCT00142415|B7|Baseline|Total|Total of all reporting groups
1233280|NCT00142415|B6|Baseline|Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 65 mCi/m^2 of 177-Lu."
1233281|NCT00142415|B5|Baseline|Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 70 mCi/m^2 of 177-Lu."
1233282|NCT00142415|B4|Baseline|Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 60 mCi/m^2 of 177-Lu."
1233283|NCT00142415|B3|Baseline|Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 50 mCi/m^2 of 177-Lu."
1233284|NCT00142415|B2|Baseline|Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 40 mCi/m^2 of 177-Lu."
1233285|NCT00142415|B1|Baseline|Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 mCi/m^2 of 177-Lu."
1233286|NCT00142415|P6|Participant Flow|Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 65 mCi/m^2 of 177-Lu."
1233287|NCT00142415|P5|Participant Flow|Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 70 mCi/m^2 of 177-Lu."
1233288|NCT00142415|P4|Participant Flow|Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 60 mCi/m^2 of 177-Lu."
1233289|NCT00142415|P3|Participant Flow|Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 50 mCi/m^2 of 177-Lu."
1233290|NCT00142415|P2|Participant Flow|Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 40 mCi/m^2 of 177-Lu."
1233291|NCT00142415|P1|Participant Flow|Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 mCi/m^2 of 177-Lu."
1233292|NCT00142415|O6|Outcome|Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 65 mCi/m^2 of 177-Lu."
1233293|NCT00142415|O5|Outcome|Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 70 mCi/m^2 of 177-Lu."
1233294|NCT00142415|O4|Outcome|Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 60 mCi/m^2 of 177-Lu."
1233295|NCT00142415|O3|Outcome|Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 50 mCi/m^2 of 177-Lu."
1233296|NCT00142415|O2|Outcome|Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 40 mCi/m^2 of 177-Lu."
1233297|NCT00142415|O1|Outcome|Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 mCi/m^2 of 177-Lu."
1233298|NCT00142415|O1|Outcome|Dosimetry Evaluable Analysis Set|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 to 70 mCi/m^2 of 177-Lu."
1233299|NCT00142415|O6|Outcome|Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 65 mCi/m^2 of 177-Lu."
1233300|NCT00142415|O5|Outcome|Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 70 mCi/m^2 of 177-Lu."
1233301|NCT00142415|O4|Outcome|Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 60 mCi/m^2 of 177-Lu."
1233302|NCT00142415|O3|Outcome|Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 50 mCi/m^2 of 177-Lu."
1233303|NCT00142415|O2|Outcome|Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 40 mCi/m^2 of 177-Lu."
1233372|NCT00143390|B1|Baseline|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
1233304|NCT00142415|O1|Outcome|Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 mCi/m^2 of 177-Lu."
1233305|NCT00142415|O6|Outcome|Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 65 mCi/m^2 of 177-Lu."
1233306|NCT00142415|O5|Outcome|Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 70 mCi/m^2 of 177-Lu."
1233307|NCT00142415|O4|Outcome|Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 60 mCi/m^2 of 177-Lu."
1233308|NCT00142415|O3|Outcome|Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 50 mCi/m^2 of 177-Lu."
1233309|NCT00142415|O2|Outcome|Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 40 mCi/m^2 of 177-Lu."
1233310|NCT00142415|O1|Outcome|Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 mCi/m^2 of 177-Lu."
1233311|NCT00142415|E7|Reported Event|Total|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 to 70 mCi/m^2 of 177-Lu."
1233312|NCT00142415|E6|Reported Event|Cohort 6, 65 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 65 mCi/m^2 of 177-Lu."
1233313|NCT00142415|E5|Reported Event|Cohort 5, 70 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 70 mCi/m^2 of 177-Lu."
1233314|NCT00142415|E4|Reported Event|Cohort 4, 60 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 60 mCi/m^2 of 177-Lu."
1233315|NCT00142415|E3|Reported Event|Cohort 3, 50 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 50 mCi/m^2 of 177-Lu."
1233316|NCT00142415|E2|Reported Event|Cohort 2, 40 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 40 mCi/m^2 of 177-Lu."
1233317|NCT00142415|E1|Reported Event|Cohort 1, 30 mCi/m^2 177-Lu-DOTA-cG250|"111-In-DOTA-cG250: On Day 1, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.~177-Lu-DOTA-cG250: On Day 8, 9, or 10, subjects received a single dose of 10 mg of cG250 coupled to DOTA and labeled with 30 mCi/m^2 of 177-Lu."
1233318|NCT00142298|B11|Baseline|Total|Total of all reporting groups
1233319|NCT00142298|B10|Baseline|Group C: Other Feeder Studies|Patients with either compensated or decompensated chronic hepatitis B, from 2401 (NCT00115245), 2402 (NCT00132652) and 010 (NCT00124241). Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
1233320|NCT00142298|B9|Baseline|Group C: LAM Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
1233321|NCT00142298|B8|Baseline|Group C: LdT Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
1233322|NCT00142298|B7|Baseline|Group B: LAM 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration studies 2301 (NCT00076336) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
1233323|NCT00142298|B6|Baseline|Group B: LdT 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration study 2301 (NCT00076336) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
1233324|NCT00142298|B5|Baseline|Group A: Feeder Study 010|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
1233567|NCT00141778|B2|Baseline|Ramipril|Angiotensin-converting enzyme inhibitor group
1233568|NCT00141778|B1|Baseline|Placebo|Placebo Group
1233325|NCT00142298|B4|Baseline|Group A: Feeder Study 2402|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
1233326|NCT00142298|B3|Baseline|Group A: Feeder Study 2401|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2401 (NCT00115245) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
1233327|NCT00142298|B2|Baseline|Group A : LAM Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
1233328|NCT00142298|B1|Baseline|Group A : LdT Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
1233329|NCT00142298|P10|Participant Flow|Group C: Other Feeder Studies|Patients with either compensated or decompensated chronic hepatitis B, from 2401 (NCT00115245), 2402 (NCT00132652) and 010 (NCT00124241). Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
1233330|NCT00142298|P9|Participant Flow|Group C: LAM Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
1233331|NCT00142298|P8|Participant Flow|Group C: LdT Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
1233332|NCT00142298|P7|Participant Flow|Group B: LAM 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration studies 2301 (NCT00076336) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
1233333|NCT00142298|P6|Participant Flow|Group B: LdT 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration study 2301 (NCT00076336) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
1233334|NCT00142298|P5|Participant Flow|Group A: Feeder Study 010|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
1233335|NCT00142298|P4|Participant Flow|Group A: Feeder Study 2402|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
1233336|NCT00142298|P3|Participant Flow|Group A: Feeder Study 2401|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2401 (NCT00115245) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
1233337|NCT00142298|P2|Participant Flow|Group A : LAM Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
1233338|NCT00142298|P1|Participant Flow|Group A : LdT Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
1233339|NCT00142298|O1|Outcome|Group C : Other Feeder Studies|Patients with either compensated or decompensated chronic hepatitis B, from 2401 (NCT00115245), 2402 (NCT00132652) and 010 (NCT00124241). Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
1233340|NCT00142298|O2|Outcome|Group C: LAM Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
1233341|NCT00142298|O1|Outcome|Group C : LdT Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
1233342|NCT00142298|O1|Outcome|Group B : LAM 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration studies 2301 (NCT00076336) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
1233343|NCT00142298|O1|Outcome|Group B : LdT 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration study 2301 (NCT00076336) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
1233569|NCT00141778|P3|Participant Flow|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist Group.Spironolactone was given as 25 mg/day.
1233344|NCT00142298|O3|Outcome|Group A: Feeder Study 010|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
1233345|NCT00142298|O2|Outcome|Group A: Feeder Study 2402|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
1233346|NCT00142298|O1|Outcome|Group A: Feeder Study 2401|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2401 (NCT00115245) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
1233347|NCT00142298|O1|Outcome|Group A : LAM Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
1233348|NCT00142298|O1|Outcome|Group A : LdT Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
1233349|NCT00142298|E10|Reported Event|Group C : Other Feeder Studies|Patients with either compensated or decompensated chronic hepatitis B, from 2401 (NCT00115245), 2402 (NCT00132652) and 010 (NCT00124241). Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
1233350|NCT00142298|E9|Reported Event|Group C: Lam Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
1233351|NCT00142298|E8|Reported Event|Group C : LdT Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
1233352|NCT00142298|E7|Reported Event|Group B: Lam 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration studies 2301 (NCT00076336) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
1233353|NCT00142298|E6|Reported Event|Group B: LdT 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration study 2301 (NCT00076336) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
1233354|NCT00142298|E5|Reported Event|Group A: Feeder 2402|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
1233355|NCT00142298|E4|Reported Event|Group A: Feeder 2401|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2401 (NCT00115245) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
1233356|NCT00142298|E3|Reported Event|Group A: Feeder Study 010|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
1233357|NCT00142298|E2|Reported Event|Group A : LAM Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
1233358|NCT00142298|E1|Reported Event|Group A : LdT Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
1233359|NCT00143403|B3|Baseline|Total|Total of all reporting groups
1233360|NCT00143403|B2|Baseline|Irinotecan + 5-FU/FA|irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
1233361|NCT00143403|B1|Baseline|5-FU/FA|simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
1233362|NCT00143403|P2|Participant Flow|Irinotecan + 5-FU/FA|irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
1233363|NCT00143403|P1|Participant Flow|5-FU/FA|simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
1233364|NCT00143403|O2|Outcome|Irinotecan + 5-FU/FA|irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
1233365|NCT00143403|O1|Outcome|5-FU/FA|simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
1233366|NCT00143403|O2|Outcome|Irinotecan + 5-FU/FA|irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
1233367|NCT00143403|O1|Outcome|5-FU/FA|simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
1233368|NCT00143403|E2|Reported Event|Irinotecan + 5-FU/FA|irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
1233369|NCT00143403|E1|Reported Event|5-FU/FA|simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
1233370|NCT00143390|B3|Baseline|Total|Total of all reporting groups
1233371|NCT00143390|B2|Baseline|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
1233827|NCT00141453|O2|Outcome|Placebo Comparator|Matching placebo tablets
1233373|NCT00143390|P2|Participant Flow|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
1233374|NCT00143390|P1|Participant Flow|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
1233375|NCT00143390|O2|Outcome|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
1233376|NCT00143390|O1|Outcome|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
1233377|NCT00143390|O2|Outcome|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
1233378|NCT00143390|O1|Outcome|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
1233379|NCT00143390|O2|Outcome|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
1233380|NCT00143390|O1|Outcome|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
1233381|NCT00143390|O2|Outcome|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
1233382|NCT00143390|O1|Outcome|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
1233383|NCT00143390|O2|Outcome|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
1233384|NCT00143390|O1|Outcome|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
1233385|NCT00143390|O2|Outcome|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
1233386|NCT00143390|O1|Outcome|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
1233387|NCT00143390|E2|Reported Event|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
1233388|NCT00143390|E1|Reported Event|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
1233389|NCT00143312|B1|Baseline|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
1233390|NCT00143312|P1|Participant Flow|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
1233391|NCT00143312|O1|Outcome|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
1233392|NCT00143312|O1|Outcome|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
1233393|NCT00143312|O1|Outcome|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
1233394|NCT00143312|O1|Outcome|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
1233414|NCT00142935|B3|Baseline|MMT Referral Post Release|Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.
1243715|NCT00110305|B1|Baseline|TMC278 25 mg|TMC278 25 mg once daily
1233395|NCT00143312|O1|Outcome|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
1233396|NCT00143312|O1|Outcome|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
1233397|NCT00143312|O1|Outcome|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
1233398|NCT00143312|E1|Reported Event|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
1233399|NCT00143247|B1|Baseline|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
1233400|NCT00143247|P1|Participant Flow|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
1233401|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
1233402|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
1233403|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
1233404|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
1233405|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
1233406|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
1233407|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
1233408|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
1233409|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
1233410|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
1233411|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
1233412|NCT00143247|E1|Reported Event|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
1233413|NCT00142935|B4|Baseline|Total|Total of all reporting groups
1234519|NCT00139997|O1|Outcome|LED Phototherapy|Phototherapy with light-emitting diode phototherapy device
1233415|NCT00142935|B2|Baseline|MMT Referral Post Release + Payment|Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs.
1233416|NCT00142935|B1|Baseline|Pre-release MMT Initiation + Referral Post Release + Payment|Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs.
1233417|NCT00142935|P3|Participant Flow|MMT Referral Post Release|Participants assigned to this arm will not begin treatment prior to release from incarceration or have treatment paid for by the study. However, study staff will work with participants to identify ways to pay for treatment, including assisting with Medicaid applications, etc. Further, the study will make the logistical arrangements for entering treatment if participant has a means to finance MMT.
1233418|NCT00142935|P2|Participant Flow|MMT Referral Post Release + Payment|Participants assigned to this arm will have all logistical arrangements made for entry into a community methadone clinic program within 24-48 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks.
1233419|NCT00142935|P1|Participant Flow|Pre-release MMT Initiation + Referral Post Release + Payment|Participants assigned to this arm will undergo extensive assessment (physical, medical history, drug use and treatment history) prior to initiating treatment. MMT will begin 1-30 days prior to release from incarceration. MMT first dose will begin at 5 mg with 2 mg increase per day until release or therapeutic dose of 60-120 mg is achieved. Daily observation by dosing nurses and twice weekly symptom review by Research Assistant will occur. Additionally, participants assigned to Arm 1 will have all logistical arrangements made for entry into a community methadone clinic program within 24 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks.
1233420|NCT00142935|O3|Outcome|As Assigned: MMT Referral Post Release|Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.
1233421|NCT00142935|O2|Outcome|As Assigned: MMT Referral Post Release + Payment|Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs.
1233422|NCT00142935|O1|Outcome|As Assigned: MMT Pre-release + Referral Post Release + Payment|Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs.
1233423|NCT00142935|O3|Outcome|As Assigned: MMT Referral Post Release|Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.
1233424|NCT00142935|O2|Outcome|As Assigned: MMT Referral Post Release + Payment|Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs.
1233425|NCT00142935|O1|Outcome|As Assigned: MMT Pre-release + Referral Post Release + Payment|Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs.
1233426|NCT00142935|O3|Outcome|As Assigned: MMT Referral Post Release|Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.
1233427|NCT00142935|O2|Outcome|As Assigned: MMT Referral Post Release + Payment|Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs.
1233428|NCT00142935|O1|Outcome|As Assigned: MMT Pre-release + Referral Post Release + Payment|Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs.
1233429|NCT00142935|O3|Outcome|As Assigned: MMT Referral Post Release|Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.
1233430|NCT00142935|O2|Outcome|As Assigned: MMT Referral Post Release + Payment|Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs.
1233431|NCT00142935|O1|Outcome|As Assigned: Pre-release MMT + Referral Post Release + Payment|Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs.
1233432|NCT00142935|O3|Outcome|As Assigned: MMT Referral Post Release|Participants enrolled in Group 3 will be referred to a methadone program of their choice upon release from incarceration without receiving financial assistance.
1233433|NCT00142935|O2|Outcome|As Assigned: MMT Referral Post Release + Payment|Participants enrolled in Group 2 will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.
1233434|NCT00142935|O1|Outcome|As Assigned: Pre-release MMT + Referral Post Release + Payment|Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.
1233435|NCT00142935|O3|Outcome|As Assigned: MMT Referral Post Release|Participants enrolled in Group 3 will be referred to a methadone program of their choice upon release from incarceration without receiving financial assistance.
1233436|NCT00142935|O2|Outcome|As Assigned: MMT Referral Post Release + Payment|Participants enrolled in Group 2 will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.
1233437|NCT00142935|O1|Outcome|As Assigned: Pre-release MMT + Referral Post Release + Payment|Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.
1245793|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
1233438|NCT00142935|E3|Reported Event|As Assigned: MMT Referral Post Release|"Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.~Fatal overdose deaths are calculated using all participants assigned to Arm 3. Other adverse events are calculated using self reported data from 12 month interviews."
1233439|NCT00142935|E2|Reported Event|As Assigned: MMT Referral Post Release + Payment|"Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs.~Fatal overdose deaths are calculated using all participants assigned to Arm 2. Other adverse events are calculated using self reported data from 12 month interviews."
1233440|NCT00142935|E1|Reported Event|As Assigned: Pre-release MMT + Referral Post Release + Payment|"Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs.~Fatal overdose deaths are calculated using all participants assigned to Arm 1. Other adverse events are calculated using self reported data from 12 month interviews."
1233441|NCT00142909|B3|Baseline|Total|Total of all reporting groups
1233442|NCT00142909|B2|Baseline|Placebo|
1233443|NCT00142909|B1|Baseline|Lofexidine|
1233444|NCT00142909|P2|Participant Flow|Placebo|Participants will receive daily placebo and follow the same schedule as the active intervention for 12 weeks.
1233445|NCT00142909|P1|Participant Flow|Lofexidine|"Lofexidine: Study medication~Participants will receive daily lofexidine and the dosing will be initiated at 0.4 mg bid and increased to 0.8mg in week 1 and 1.0 and 1.2 mg bid in week 2, and maintained at 1.2mg bid for weeks 3 to 12. They are then tapered down to 0 over the course of four days in week 12. While the target dose will be 2.4 mg daily, if any subject shows reduced tolerability at this or a lower dose, the dose will be adjusted to the maximum tolerated dose for that subject."
1233446|NCT00142909|O2|Outcome|Placebo|Placebo pill
1233447|NCT00142909|O1|Outcome|Lofexidine|Lofexidine: Study medication
1233448|NCT00142909|O2|Outcome|Placebo|Placebo pill
1233449|NCT00142909|O1|Outcome|Lofexidine|Lofexidine: Study medication
1233450|NCT00142909|O2|Outcome|Placebo|Placebo pill
1233451|NCT00142909|O1|Outcome|Lofexidine|Lofexidine: Study medication
1233452|NCT00142909|O2|Outcome|Placebo|Placebo pill
1233453|NCT00142909|O1|Outcome|Lofexidine|Lofexidine: Study medication
1233454|NCT00142909|O2|Outcome|Placebo|Placebo pill
1233455|NCT00142909|O1|Outcome|Lofexidine|Lofexidine: Study medication
1233456|NCT00142909|O2|Outcome|Placebo|Placebo pill
1233457|NCT00142909|O1|Outcome|Lofexidine|Lofexidine: Study medication
1233458|NCT00142909|E2|Reported Event|Placebo|Placebo pill
1233459|NCT00142909|E1|Reported Event|Lofexidine|Lofexidine: Study medication
1233460|NCT00142818|B5|Baseline|Total|Total of all reporting groups
1233461|NCT00142818|B4|Baseline|Double Placebo|"Placebo~Placebo: 400 mg and/or 100-150 mg placebo pills"
1233462|NCT00142818|B3|Baseline|Modafinil and Placebo|"Mod~Modafinil: 400 mg daily"
1233463|NCT00142818|B2|Baseline|Naltrexone and Placebo|"Nal~Naltrexone: 150 mg daily for males; 100 mg daily for females"
1233464|NCT00142818|B1|Baseline|ModNal|"Nal + Mod~Naltrexone: 150 mg daily for males; 100 mg daily for females~Modafinil: 400 mg daily"
1233465|NCT00142818|P4|Participant Flow|Double Placebo|"Placebo~Placebo: 400 mg and/or 100-150 mg placebo pills"
1233466|NCT00142818|P3|Participant Flow|Modafinil and Placebo|"Mod~Modafinil: 400 mg daily"
1233467|NCT00142818|P2|Participant Flow|Naltrexone and Placebo|"Nal~Naltrexone: 150 mg daily for males; 100 mg daily for females"
1233468|NCT00142818|P1|Participant Flow|ModNal|"Nal + Mod~Naltrexone: 150 mg daily for males; 100 mg daily for females~Modafinil: 400 mg daily"
1233469|NCT00142818|O4|Outcome|Double Placebo|"Placebo~Placebo: 400 mg and/or 100-150 mg placebo pills"
1233470|NCT00142818|O3|Outcome|Modafinil and Placebo|"Mod~Modafinil: 400 mg daily"
1233471|NCT00142818|O2|Outcome|Naltrexone and Placebo|"Nal~Naltrexone: 150 mg daily for males; 100 mg daily for females"
1233472|NCT00142818|O1|Outcome|ModNal|"Nal + Mod~Naltrexone: 150 mg daily for males; 100 mg daily for females~Modafinil: 400 mg daily"
1233473|NCT00142818|E4|Reported Event|Double Placebo|"Placebo~Placebo: 400 mg and/or 100-150 mg placebo pills"
1233474|NCT00142818|E3|Reported Event|Modafinil and Placebo|"Mod~Modafinil: 400 mg daily"
1233475|NCT00142818|E2|Reported Event|Naltrexone and Placebo|"Nal~Naltrexone: 150 mg daily for males; 100 mg daily for females"
1233476|NCT00142818|E1|Reported Event|ModNal|"Nal + Mod~Naltrexone: 150 mg daily for males; 100 mg daily for females~Modafinil: 400 mg daily"
1233477|NCT00142597|B3|Baseline|Total|Total of all reporting groups
1233478|NCT00142597|B2|Baseline|Sham Treatment|"Sham acupuncture is used.~Sham treatment: Fibromyalgia participants will be randomized to receive 9 sham treatments over the course of four weeks.~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
1233479|NCT00142597|B1|Baseline|Traditional Acupuncture|"Acupuncture sites will be used for active intervention.~Acupuncture: Involves the insertion and manual stimulation of thin acupuncture needles into specific points in the body.~Fibromyalgia participants will be randomized to receive 9 acupuncture treatments over the course of four weeks.~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
1233480|NCT00142597|P2|Participant Flow|Sham Treatment|"Sham acupuncture is used.~Sham treatment: Fibromyalgia participants will be randomized to receive 9 sham treatments over the course of four weeks.~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
1233481|NCT00142597|P1|Participant Flow|Traditional Acupuncture|"Acupuncture sites will be used for active intervention.~Acupuncture: Involves the insertion and manual stimulation of thin acupuncture needles into specific points in the body.~Fibromyalgia participants will be randomized to receive 9 acupuncture treatments over the course of four weeks.~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
1233482|NCT00142597|O2|Outcome|Sham Treatment|"Sham acupuncture is used.~Sham treatment: Fibromyalgia participants will be randomized to receive 9 sham treatments over the course of four weeks.~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
1233483|NCT00142597|O1|Outcome|Traditional Acupuncture|"Acupuncture sites will be used for active intervention.~Acupuncture: Involves the insertion and manual stimulation of thin acupuncture needles into specific points in the body.~Fibromyalgia participants will be randomized to receive 9 acupuncture treatments over the course of four weeks.~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
1233484|NCT00142597|E2|Reported Event|Sham Treatment|"Sham acupuncture is used.~Sham treatment: Fibromyalgia participants will be randomized to receive 9 sham treatments over the course of four weeks.~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
1233485|NCT00142597|E1|Reported Event|Traditional Acupuncture|"Acupuncture sites will be used for active intervention.~Acupuncture: Involves the insertion and manual stimulation of thin acupuncture needles into specific points in the body.~Fibromyalgia participants will be randomized to receive 9 acupuncture treatments over the course of four weeks.~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
1233486|NCT00142168|B1|Baseline|Lenalidomide and Rituximab|Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
1233487|NCT00142168|P1|Participant Flow|Lenalidomide and Rituximab|Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
1233488|NCT00142168|O1|Outcome|Lenalidomide and Rituximab|Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
1233489|NCT00142168|O1|Outcome|Lenalidomide and Rituximab|Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
1233490|NCT00142168|O1|Outcome|Lenalidomide and Rituximab|Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
1233491|NCT00142168|O1|Outcome|Lenalidomide and Rituximab|Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
1233492|NCT00142168|E1|Reported Event|Lenalidomide and Rituximab|Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
1233493|NCT00142116|B1|Baseline|All WM Patients|Waldenstrom's Macroglobulinemia Patients
1233494|NCT00142116|P1|Participant Flow|All WM Patients|Waldenstrom's Macroglobulinemia Patients
1233495|NCT00142116|O1|Outcome|Thalidomide and Rituximab|"Thalidomide 200mg orally once a day for 14 weeks if that dosage is tolerated well, it will be increased to 400mg for up to 50 weeks~Rituximab Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated well, this may be repeated 8 weeks later.~Thalidomide: 200mg orally once a day for 14 weeks if that dosage is tolerated well, it will be increased to 400mg for up to 50 weeks.~Rituximab: Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated well, this may be repeated 8 weeks later."
1233496|NCT00142116|O1|Outcome|All WM Patients|Waldenstrom's Macroglobulinemia Patients
1233497|NCT00142116|E1|Reported Event|All WM Patients|Waldenstrom's Macroglobulinemia Patients
1233520|NCT00141817|B5|Baseline|Total|Total of all reporting groups
1233521|NCT00141817|B4|Baseline|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
1233522|NCT00141817|B3|Baseline|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
1233523|NCT00141817|B2|Baseline|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
1233524|NCT00141817|B1|Baseline|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
1233525|NCT00141817|P4|Participant Flow|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
1233526|NCT00141817|P3|Participant Flow|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
1233527|NCT00141817|P2|Participant Flow|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
1233528|NCT00141817|P1|Participant Flow|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
1233529|NCT00141817|O4|Outcome|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
1233530|NCT00141817|O3|Outcome|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
1233531|NCT00141817|O2|Outcome|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
1233532|NCT00141817|O1|Outcome|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
1233533|NCT00141817|O4|Outcome|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
1233534|NCT00141817|O3|Outcome|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
1233535|NCT00141817|O2|Outcome|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
1233536|NCT00141817|O1|Outcome|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
1233537|NCT00141817|O4|Outcome|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
1233538|NCT00141817|O3|Outcome|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
1233539|NCT00141817|O2|Outcome|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
1233540|NCT00141817|O1|Outcome|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
1233541|NCT00141817|O4|Outcome|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
1233542|NCT00141817|O3|Outcome|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
1233543|NCT00141817|O2|Outcome|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
1233544|NCT00141817|O1|Outcome|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
1233547|NCT00141817|O2|Outcome|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
1233548|NCT00141817|O1|Outcome|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
1233549|NCT00141817|O4|Outcome|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
1233550|NCT00141817|O3|Outcome|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
1233551|NCT00141817|O2|Outcome|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
1233552|NCT00141817|O1|Outcome|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
1233553|NCT00141817|O4|Outcome|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
1233554|NCT00141817|O3|Outcome|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
1233555|NCT00141817|O2|Outcome|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
1233556|NCT00141817|O1|Outcome|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
1233557|NCT00141817|O4|Outcome|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
1233558|NCT00141817|O3|Outcome|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
1233559|NCT00141817|O2|Outcome|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
1233560|NCT00141817|O1|Outcome|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
1233561|NCT00141817|E4|Reported Event|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
1233562|NCT00141817|E3|Reported Event|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
1233563|NCT00141817|E2|Reported Event|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
1233564|NCT00141817|E1|Reported Event|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
1233565|NCT00141778|B4|Baseline|Total|Total of all reporting groups
1233570|NCT00141778|P2|Participant Flow|Ramipril|Angiotensin-Converting Enzyme Inhibitor Group. Ramipril was given as 2.5 mg the first 3 days followed by 5 mg/day, with the dose reduced to 2.5 mg/day on the first postoperative day only.
1233571|NCT00141778|P1|Participant Flow|Placebo|Placebo Group
1233572|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
1233573|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
1233574|NCT00141778|O1|Outcome|Placebo|Placebo Group
1233575|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
1233576|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
1233577|NCT00141778|O1|Outcome|Placebo|Placebo Group
1233578|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
1233579|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
1233580|NCT00141778|O1|Outcome|Placebo|Placebo Group
1233581|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
1233582|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
1233583|NCT00141778|O1|Outcome|Placebo|Placebo Group
1233584|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
1233585|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
1233586|NCT00141778|O1|Outcome|Placebo|Placebo Group
1233587|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
1233588|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
1233589|NCT00141778|O1|Outcome|Placebo|Placebo Group
1233590|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
1233591|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
1233592|NCT00141778|O1|Outcome|Placebo|Placebo Group
1233593|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
1233594|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
1233595|NCT00141778|O1|Outcome|Placebo|Placebo Group
1233596|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
1233597|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
1233598|NCT00141778|O1|Outcome|Placebo|Placebo Group
1233599|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
1233600|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
1233601|NCT00141778|O1|Outcome|Placebo|Placebo Group
1233602|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
1233603|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
1233604|NCT00141778|O1|Outcome|Placebo|Placebo Group
1233605|NCT00141778|E3|Reported Event|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
1233606|NCT00141778|E2|Reported Event|Ramipril|Angiotensin-converting enzyme inhibitor group
1233607|NCT00141778|E1|Reported Event|Placebo|Placebo Group
1233608|NCT00141765|B1|Baseline|Myeloablative Chemotherapy With Stem Cell Rescue|"Myeloablative Chemotherapy: High dose chemotherapy (carboplatin and thiotepa) transplant rescue~Stem Cell Rescue: autologous stem cell transplantation"
1233609|NCT00141765|P1|Participant Flow|Myeloablative Chemotherapy With Stem Cell Rescue|"Myeloablative Chemotherapy: High dose chemotherapy (carboplatin and thiotepa) transplant rescue~Stem Cell Rescue: autologous stem cell transplantation"
1233610|NCT00141765|O1|Outcome|Myeloablative Chemotherapy With Stem Cell Rescue|"Myeloablative Chemotherapy: High dose chemotherapy (carboplatin and thiotepa) transplant rescue~Stem Cell Rescue: autologous stem cell transplantation"
1234310|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
1233611|NCT00141765|E1|Reported Event|Myeloablative Chemotherapy With Stem Cell Rescue|"Myeloablative Chemotherapy: High dose chemotherapy (carboplatin and thiotepa) transplant rescue~Stem Cell Rescue: autologous stem cell transplantation"
1233612|NCT00141739|B1|Baseline|GVHD Prophylaxis|"GVHD prophylaxis with etanercept~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
1233613|NCT00141739|P1|Participant Flow|GVHD Prophylaxis|"GVHD prophylaxis with etanercept~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
1233614|NCT00141739|O2|Outcome|Non-TBI|"GVHD prophylaxis with etanercept~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
1233615|NCT00141739|O1|Outcome|Total Body Irradiation (TBI)|"GVHD prophylaxis with etanercept in patients receiving Total Body Irradiation (TBI) transplant conditioning.~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
1233616|NCT00141739|O2|Outcome|Non-TBI|"GVHD prophylaxis with etanercept~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
1233617|NCT00141739|O1|Outcome|Total Body Irradiation (TBI)|"GVHD prophylaxis with etanercept in patients receiving Total Body Irradiation (TBI) transplant conditioning.~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
1233828|NCT00141453|O1|Outcome|Olmesartan Medoxomil|Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
1233829|NCT00141453|O2|Outcome|Placebo Comparator|Matching placebo tablets
1233618|NCT00141739|O2|Outcome|Non-TBI|"GVHD prophylaxis with etanercept~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
1233619|NCT00141739|O1|Outcome|Total Body Irradiation (TBI)|"GVHD prophylaxis with etanercept in patients receiving Total Body Irradiation (TBI) transplant conditioning.~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
1233620|NCT00141739|O1|Outcome|GVHD Prophylaxis|"GVHD prophylaxis with etanercept~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
1233621|NCT00141739|O1|Outcome|GVHD Prophylaxis|"GVHD prophylaxis with etanercept~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
1233622|NCT00141739|E1|Reported Event|GVHD Prophylaxis|"GVHD prophylaxis with etanercept~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
1233623|NCT00141726|B1|Baseline|Etanercept Treatment|"Etanercept for lung injury~Etanercept: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages."
1233624|NCT00141726|P1|Participant Flow|Etanercept Treatment|"Etanercept for lung injury~Etanercept: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages."
1233625|NCT00141726|O1|Outcome|Etanercept Treatment|"Etanercept for lung injury~Etanercept: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages."
1233626|NCT00141726|O1|Outcome|Etanercept Treatment|"Etanercept for lung injury~Etanercept: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages."
1233627|NCT00141726|E1|Reported Event|Etanercept Treatment|"Etanercept for lung injury~Etanercept: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages."
1233628|NCT00141518|B4|Baseline|Total|Total of all reporting groups
1233629|NCT00141518|B3|Baseline|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233630|NCT00141518|B2|Baseline|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233631|NCT00141518|B1|Baseline|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233632|NCT00141518|P3|Participant Flow|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233633|NCT00141518|P2|Participant Flow|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233634|NCT00141518|P1|Participant Flow|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233635|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233830|NCT00141453|O1|Outcome|Olmesartan Medoxomil|Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
1233831|NCT00141453|O2|Outcome|Placebo Comparator|Matching placebo tablets
1233636|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233637|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233638|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233639|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233640|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233641|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233642|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233643|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233644|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233645|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233646|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233647|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233648|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233649|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233832|NCT00141453|O1|Outcome|Olmesartan Medoxomil|Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
1233833|NCT00141453|E2|Reported Event|Placebo Comparator|Matching placebo tablets
1233650|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233651|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233652|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233653|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233654|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233655|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233656|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233657|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233658|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233659|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233660|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233661|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233662|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233663|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233834|NCT00141453|E1|Reported Event|Olmesartan Medoxomil|Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
1233835|NCT00141297|B3|Baseline|Total|Total of all reporting groups
1233664|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233665|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233666|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233667|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233668|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233669|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233670|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233671|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233672|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233673|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233674|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233675|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233676|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233677|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1234153|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1233678|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233679|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233680|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233681|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233682|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233683|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233684|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233685|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233686|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233687|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233688|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233689|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233690|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233691|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1234154|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234155|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1233692|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233693|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233694|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233695|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233696|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233697|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233698|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233699|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233700|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233701|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233702|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233703|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233704|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233705|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1234156|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1233706|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233707|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233708|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233709|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233710|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233711|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233712|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233713|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233714|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233715|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233716|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233717|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233718|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233719|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1234157|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1233720|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233721|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233722|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233723|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233724|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233725|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233726|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233727|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233728|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233729|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233730|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233731|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233732|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233733|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1234158|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1234159|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1233734|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233735|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233736|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233737|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233738|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233739|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233740|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233741|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233742|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233743|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233744|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233745|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233746|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233747|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1234160|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1233748|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233749|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233750|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233751|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233752|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233753|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233754|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233755|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233756|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233757|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233758|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233759|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233760|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233761|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1234161|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1234351|NCT00140842|B2|Baseline|Obese Girls|Obese girls were required to have a BMI above the 95th percentile
1233762|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233763|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233764|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233765|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233766|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233767|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233768|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233769|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233770|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233771|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233772|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233773|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233774|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233775|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1234162|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1247975|NCT00098059|O1|Outcome|1 to < 2 Years|
1233776|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233777|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233778|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233779|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233780|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233781|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233782|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233783|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233784|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233785|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233786|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233787|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233788|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233789|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1234163|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1233790|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233791|NCT00141518|O1|Outcome|Total|Duodopa-naïve participants, Duodopa non-naïve participants treated with Duodopa for < 2 years, and Duodopa non-naïve participants treated with Duodopa for ≥ 2 years received Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233792|NCT00141518|O4|Outcome|Total|All participants
1233793|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233794|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233795|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233796|NCT00141518|O4|Outcome|Total|All participants
1233797|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233798|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233799|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233800|NCT00141518|O4|Outcome|Total|All participants
1234187|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234188|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1233801|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233802|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233803|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233804|NCT00141518|O4|Outcome|Total|All participants
1233805|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233806|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233859|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233807|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233808|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233809|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233810|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233811|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233812|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233813|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233814|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233848|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233815|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233816|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233817|NCT00141518|E3|Reported Event|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233818|NCT00141518|E2|Reported Event|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233819|NCT00141518|E1|Reported Event|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
1233820|NCT00141453|B3|Baseline|Total|Total of all reporting groups
1233821|NCT00141453|B2|Baseline|Placebo Comparator|Matching placebo tablets
1233822|NCT00141453|B1|Baseline|Olmesartan Medoxomil|Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
1233823|NCT00141453|P2|Participant Flow|Placebo Comparator|Matching placebo tablets
1233824|NCT00141453|P1|Participant Flow|Olmesartan Medoxomil|Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
1233825|NCT00141453|O2|Outcome|Placebo Comparator|Matching placebo tablets
1233826|NCT00141453|O1|Outcome|Olmesartan Medoxomil|Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
1233836|NCT00141297|B2|Baseline|PD 0332991 (14/21 Days)|Participants received PD 0332991 capsule orally once daily (QD), continuously for 14 days in 21-day cycles in dose escalation schemes of 100 mg, 150 mg and 200 mg, 225 mg. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233837|NCT00141297|B1|Baseline|PD 0332991 (21/28 Days)|Participants received PD 0332991 capsule orally once daily (QD), continuously for 21 days in 28-day cycles in dose escalation schemes of 25 mg, 50 mg, 75 mg, 100 mg, 125 mg and 150 mg. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233838|NCT00141297|P10|Participant Flow|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233839|NCT00141297|P9|Participant Flow|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233840|NCT00141297|P8|Participant Flow|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233841|NCT00141297|P7|Participant Flow|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233842|NCT00141297|P6|Participant Flow|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233843|NCT00141297|P5|Participant Flow|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233844|NCT00141297|P4|Participant Flow|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233845|NCT00141297|P3|Participant Flow|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233846|NCT00141297|P2|Participant Flow|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233847|NCT00141297|P1|Participant Flow|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234189|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1233849|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233850|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233851|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233852|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233853|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233854|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233855|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233856|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233857|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233858|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234148|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1233860|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233861|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233862|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233863|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233864|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233865|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233866|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233867|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233868|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233869|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233870|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233871|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233872|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234190|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234191|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1233873|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233874|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233875|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233876|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233877|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233878|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233879|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233880|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233881|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233882|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233883|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234149|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1233884|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233885|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233886|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233887|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233888|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233889|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233890|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233891|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233892|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233893|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233894|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233895|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233896|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233897|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233898|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233899|NCT00141297|O2|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233900|NCT00141297|O1|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233901|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233902|NCT00141297|O2|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233903|NCT00141297|O1|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233904|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233905|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234150|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234164|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1233906|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233907|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233908|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233909|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233910|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233911|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233912|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233913|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233914|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233915|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233916|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233917|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234467|NCT00140231|E2|Reported Event|Placebo|"Placebo, administered in same method as active arm.~placebo: placebo (no active drug)"
1233918|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233919|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233920|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233921|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233922|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233923|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233924|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233925|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233926|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233927|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233928|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233929|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233930|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233931|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233932|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233933|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233934|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233935|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233936|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233937|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233938|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233939|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234738|NCT00138645|E2|Reported Event|Healthy Diet|participants randomized to the low-calorie diet.
1233940|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233941|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233942|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233943|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233944|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233945|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233946|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233947|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233948|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233949|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233950|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233951|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233952|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233953|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233954|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233955|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233956|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233957|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233958|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233959|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233960|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233961|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234192|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1233962|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233963|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233964|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233965|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233966|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233967|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233968|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233969|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233970|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233971|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233972|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233973|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233974|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233975|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233976|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233977|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233978|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233979|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233980|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233981|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233982|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233983|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234005|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233984|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233985|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233986|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233987|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233988|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233989|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233990|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233991|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233992|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233993|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233994|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233995|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234352|NCT00140842|B1|Baseline|Normal-weight Girls|Normal-weight girls were required to have a BMI between the 15th-85th percentiles
1233996|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233997|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233998|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1233999|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234000|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234001|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234002|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234003|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234004|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1246136|NCT00104650|E3|Reported Event|Denosumab 180 mg Q4W|
1234006|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234007|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234008|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234009|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234010|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234011|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234012|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234013|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234014|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234015|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234016|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234017|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234151|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234018|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234019|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234020|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234021|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234022|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234023|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234024|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234025|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234026|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234027|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234028|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234029|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234030|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234031|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234032|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234033|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234034|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234035|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234036|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234037|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234038|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234039|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234152|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1234040|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234041|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234042|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234043|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234044|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234045|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234046|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234047|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234048|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234049|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234184|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234050|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234051|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234052|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234053|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234054|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234055|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234056|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234057|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234058|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234059|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234060|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234061|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234062|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234353|NCT00140842|P2|Participant Flow|Obese Girls|Obese adolescents between 12–18 years old.
1234063|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234064|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234065|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234066|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234067|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234068|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234069|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234070|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234071|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234072|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234185|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1234739|NCT00138645|E1|Reported Event|MicroDiet|Participants randomized to the MicroDiet
1234073|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234074|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234075|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234076|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234077|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234078|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234079|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234080|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234081|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234082|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234083|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234084|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234085|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234086|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1247976|NCT00098059|O4|Outcome|13 to <= 18 Years|
1234087|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234088|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234089|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234090|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234091|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234092|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234093|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234094|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234095|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234096|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234097|NCT00141297|O2|Outcome|PD 0332991 (14/21 Days)|Participants received PD 0332991 capsule orally once daily (QD), continuously for 14 days in 21-day cycles in dose escalation schemes of 100 mg, 150 mg and 200 mg, 225 mg. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234098|NCT00141297|O1|Outcome|PD 0332991 (21/28 Days)|Participants received PD 0332991 capsule orally once daily (QD), continuously for 21 days in 28-day cycles in dose escalation schemes of 25 mg, 50 mg, 75 mg, 100 mg, 125 mg and 150 mg. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234099|NCT00141297|O2|Outcome|PD 0332991 (14/21 Days)|Participants received PD 0332991 capsule orally once daily (QD), continuously for 14 days in 21-day cycles in dose escalation schemes of 100 mg, 150 mg and 200 mg, 225 mg. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234100|NCT00141297|O1|Outcome|PD 0332991 (21/28 Days)|Participants received PD 0332991 capsule orally once daily (QD), continuously for 21 days in 28-day cycles in dose escalation schemes of 25 mg, 50 mg, 75 mg, 100 mg, 125 mg and 150 mg. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234101|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234102|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234103|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234104|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234105|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234106|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234107|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234108|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234109|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234354|NCT00140842|P1|Participant Flow|Normal-weight Girls|Normal weight girls 12-18 years old
1234110|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234111|NCT00141297|E10|Reported Event|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234112|NCT00141297|E9|Reported Event|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234113|NCT00141297|E8|Reported Event|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234114|NCT00141297|E7|Reported Event|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234115|NCT00141297|E6|Reported Event|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234116|NCT00141297|E5|Reported Event|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234117|NCT00141297|E4|Reported Event|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234118|NCT00141297|E3|Reported Event|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234186|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234740|NCT00138424|B5|Baseline|Total|Total of all reporting groups
1234119|NCT00141297|E2|Reported Event|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234120|NCT00141297|E1|Reported Event|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
1234121|NCT00141271|B4|Baseline|Total|Total of all reporting groups
1234122|NCT00141271|B3|Baseline|Placebo|Subjects were assigned to placebo
1234123|NCT00141271|B2|Baseline|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234124|NCT00141271|B1|Baseline|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234125|NCT00141271|P3|Participant Flow|Placebo|Subjects were assigned to placebo
1234126|NCT00141271|P2|Participant Flow|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234127|NCT00141271|P1|Participant Flow|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234128|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1234129|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234130|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234131|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1234132|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234133|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234134|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1234135|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234136|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234137|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1234138|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234139|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234140|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1234141|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234142|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234143|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1234144|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234145|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234146|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1234147|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234355|NCT00140842|O2|Outcome|Obese Girls|Obese girls were required to have a BMI above the 95th percentile
1234165|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234166|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234167|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1234168|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234169|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234170|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1234171|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234172|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234173|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1234174|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234175|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234176|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1234177|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234178|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234179|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1234180|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234181|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234182|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1234183|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234193|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234194|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1234195|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234196|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234197|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1234198|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234199|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234200|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1234201|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234202|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234203|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1234204|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234205|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234206|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1234207|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234208|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234209|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1234210|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234211|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234212|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1234213|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234214|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234215|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1234216|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234217|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234218|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1234219|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234220|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234221|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1234222|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234223|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234224|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1234225|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234226|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234227|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1234228|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234229|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234230|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1234231|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234232|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234233|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1234234|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234235|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234236|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1234237|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234238|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234239|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
1234240|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234241|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234242|NCT00141271|E3|Reported Event|Placebo|Subjects were assigned to placebo
1234243|NCT00141271|E2|Reported Event|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
1234244|NCT00141271|E1|Reported Event|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
1234245|NCT00141219|B3|Baseline|Total|Total of all reporting groups
1234246|NCT00141219|B2|Baseline|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
1234247|NCT00141219|B1|Baseline|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
1234248|NCT00141219|P2|Participant Flow|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
1234249|NCT00141219|P1|Participant Flow|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
1234250|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
1234251|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
1234252|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
1234253|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
1234254|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
1234255|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
1234256|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
1234257|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
1234258|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
1234259|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
1234260|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
1234261|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
1234262|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
1234263|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
1234264|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
1234265|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
1234266|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
1234267|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
1234268|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
1234269|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
1234270|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
1234271|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
1234272|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
1234273|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
1234274|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
1234309|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
1246137|NCT00104650|E2|Reported Event|Denosumab 180 mg Q12W|
1234275|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
1234276|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
1234277|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
1234278|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
1234279|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
1234280|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
1234281|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
1234282|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
1234283|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
1234284|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
1234285|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
1234286|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
1234287|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
1234288|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
1234333|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
1234289|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
1234290|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
1234291|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
1234292|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
1234293|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
1234294|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
1234295|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
1234296|NCT00141219|E2|Reported Event|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
1234297|NCT00141219|E1|Reported Event|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
1234298|NCT00141102|B3|Baseline|Total|Total of all reporting groups
1234299|NCT00141102|B2|Baseline|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.
1234300|NCT00141102|B1|Baseline|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
1234301|NCT00141102|P2|Participant Flow|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
1234302|NCT00141102|P1|Participant Flow|Celecoxib|200 milligrams (mg) twice daily (BID) plus omeprazole placebo and diclofenac slow release (SR) placebo
1234303|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
1234304|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
1234305|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
1234306|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
1234307|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
1234308|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
1234311|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.
1234312|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
1234313|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
1234314|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
1234315|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.
1234316|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
1234317|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
1234318|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
1234319|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
1234320|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
1234321|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
1234322|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
1234323|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.
1234324|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
1234325|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
1234326|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
1234327|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
1234328|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
1234329|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
1234330|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
1234331|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
1234332|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
1234334|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
1234335|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
1234336|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
1234337|NCT00141102|E2|Reported Event|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
1234338|NCT00141102|E1|Reported Event|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
1234339|NCT00141037|B3|Baseline|Total|Total of all reporting groups
1234340|NCT00141037|B2|Baseline|Steroid-Based Immunosuppression|Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing <40kg and 1.5 mg/kg/day in subjects weighing >40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
1234341|NCT00141037|B1|Baseline|Steroid-Free Immunosuppression|Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
1234342|NCT00141037|P2|Participant Flow|Steroid-Based Immunosuppression|Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing <40kg and 1.5 mg/kg/day in subjects weighing >40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
1234343|NCT00141037|P1|Participant Flow|Steroid-Free Immunosuppression|Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
1234344|NCT00141037|O2|Outcome|Steroid-Based Immunosuppression|Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing <40kg and 1.5 mg/kg/day in subjects weighing >40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
1234345|NCT00141037|O1|Outcome|Steroid-Free Immunosuppression|Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
1234346|NCT00141037|O2|Outcome|Steroid-Based Immunosuppression|Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing <40kg and 1.5 mg/kg/day in subjects weighing >40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
1234347|NCT00141037|O1|Outcome|Steroid-Free Immunosuppression|Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
1234348|NCT00141037|E2|Reported Event|Steroid-Free Immunosuppression|Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
1234349|NCT00141037|E1|Reported Event|Steroid-Based Immunosuppression|Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing <40kg and 1.5 mg/kg/day in subjects weighing >40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
1234356|NCT00140842|O1|Outcome|Normal-weight Girls|Normal-weight girls were required to have a BMI between the 15th-85th percentiles
1234357|NCT00140842|O2|Outcome|Obese Girls|Obese girls were required to have a BMI above the 95th percentile
1234358|NCT00140842|O1|Outcome|Normal-weight Girls|Normal-weight girls were required to have a BMI between the 15th-85th percentiles
1234359|NCT00140842|E2|Reported Event|Obese Girls|Obese girls were required to have a BMI above the 95th percentile
1234360|NCT00140842|E1|Reported Event|Normal-weight Girls|Normal-weight girls were required to have a BMI between the 15th-85th percentiles
1234361|NCT00140621|B1|Baseline|Agalsidase Beta|Agalsidase beta 1 mg/kg intravenously once every 2 weeks up to 156 weeks.
1234362|NCT00140621|P1|Participant Flow|Agalsidase Beta (Fabrazyme [Recombinant Form])|Agalsidase beta 1 milligram per kilogram (mg/kg) intravenously once every 2 weeks up to 156 weeks.
1234363|NCT00140621|O1|Outcome|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
1234364|NCT00140621|O1|Outcome|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
1234365|NCT00140621|O1|Outcome|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
1234366|NCT00140621|O1|Outcome|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
1234367|NCT00140621|O1|Outcome|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
1234368|NCT00140621|O1|Outcome|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
1234369|NCT00140621|O1|Outcome|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
1234370|NCT00140621|E1|Reported Event|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
1234371|NCT00140556|B1|Baseline|Entire Study Population|
1234372|NCT00140556|P1|Participant Flow|Entire Study Population|
1234373|NCT00140556|O1|Outcome|Entire Study Population|
1234374|NCT00140556|E1|Reported Event|Entire Study Population|
1234375|NCT00140426|B3|Baseline|Total|Total of all reporting groups
1234376|NCT00140426|B2|Baseline|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
1234377|NCT00140426|B1|Baseline|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
1234378|NCT00140426|P2|Participant Flow|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
1234379|NCT00140426|P1|Participant Flow|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
1234427|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
1234380|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
1234381|NCT00140426|O1|Outcome|Risperidone or Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
1234382|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
1234383|NCT00140426|O1|Outcome|Risperidone or Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
1234384|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
1234385|NCT00140426|O1|Outcome|Risperidone or Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
1234386|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
1234387|NCT00140426|O1|Outcome|Risperidone or Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
1234388|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
1234389|NCT00140426|O1|Outcome|Risperidone or Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
1234390|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: this group of patients received the active study medication. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
1234520|NCT00139997|E2|Reported Event|Inactive Intervention|Equivalent exposure to inactive negative ion generator
1234391|NCT00140426|O1|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~This subject group received placebo tablets which appeared identical to risperidone"
1234392|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
1234393|NCT00140426|O1|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
1234394|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
1234395|NCT00140426|O1|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
1234396|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
1234397|NCT00140426|O1|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
1234398|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
1234399|NCT00140426|O1|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
1234400|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication.~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
1234401|NCT00140426|O1|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. This is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
1234402|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
1234403|NCT00140426|O1|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
1234404|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
1234405|NCT00140426|O1|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
1234406|NCT00140426|E2|Reported Event|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
1234407|NCT00140426|E1|Reported Event|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
1234408|NCT00140413|B4|Baseline|Total|Total of all reporting groups
1234409|NCT00140413|B3|Baseline|Treatment Group 2: Control|Subjects with normal growth were randomized to treatment or to control (no intervention).
1234410|NCT00140413|B2|Baseline|Treatment Group 1B: Randomized to GH|Subjects with normal growth were randomized to GH treatment or to control (no intervention).
1234411|NCT00140413|B1|Baseline|Treatment Group 1A: Assigned to GH|Subjects with growth deceleration were assigned to the GH replacement treatment group in accordance with standard of care.
1234412|NCT00140413|P2|Participant Flow|Treatment Group 2: Control|Treatment group assignment was based on subject’s stature SDS relative to the mid-parental target height (MPTH) at baseline and subsequent classification as growth deceleration or normal growth. Subjects with normal growth were randomized to treatment or to control. The control group received no intervention; however, control subjects were switched (crossed over) to the GH replacement group if, during the course of the study, they met criteria for growth deceleration.
1234413|NCT00140413|P1|Participant Flow|Treatment Group 1: Receiving Growth Hormone Treatment|Treatment group assignment was based on subject’s stature SDS relative to the mid-parental target height (MPTH) at baseline and subsequent classification as growth deceleration or normal growth. Subjects with growth deceleration were assigned to the GH replacement treatment group in accordance with standard of care. Subjects with normal growth were randomized to treatment or to control (no intervention). The starting dose for GH replacement was calculated as 0.3 mg/kg/wk and subsequently modified based on observed length/height velocity and serum IGF-I levels.
1234414|NCT00140413|O3|Outcome|Treatment Group 3: Control Crossed Over to Treatment|3 control subjects were switched (crossed over) to the GH replacement group during the course of the study due to growth deceleration.
1234444|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
1234521|NCT00139997|E1|Reported Event|LED Phototherapy|Phototherapy with light-emitting diode phototherapy device
1234415|NCT00140413|O2|Outcome|Treatment Group 2: Control|"Treatment group assignment was based on subject’s stature SDS relative to the mid-parental target height (MPTH) at baseline and subsequent classification as growth deceleration or normal growth. Subjects with normal growth were randomized to treatment or to control. The control group received no intervention; however control subjects were switched (crossed over) to the GH replacement group if, during the course of the study, they met criteria for growth deceleration.~A total of 7 subjects were randomized to the control group, 3 of whom were crossed over to treatment due to growth deceleration. Outcome measures for these 3 who crossed over were analyzed separately, under Treatment Group 3."
1234416|NCT00140413|O1|Outcome|Treatment Group 1: Receiving Growth Hormone Treatment|Treatment group assignment was based on subject’s stature SDS relative to the mid-parental target height (MPTH) at baseline and subsequent classification as growth deceleration or normal growth. Subjects with growth deceleration were assigned to the GH replacement treatment group in accordance with standard of care. Subjects with normal growth were randomized to treatment or to control (no intervention). The starting daily dose for GH replacement was calculated as 0.3 mg/kg/wk and subsequently modified based on observed length/height velocity and serum IGF-I levels.
1234417|NCT00140413|E2|Reported Event|Treatment Group 2: Control|The denominator below (# at risk) is based on the number of subjects in Group 2 who received at least one dose of growth hormone. Per protocol, control subjects received no intervention; however, 3 control subjects were switched (crossed over) to the GH replacement group during the course of the study due to growth deceleration.
1234418|NCT00140413|E1|Reported Event|Treatment Group 1: Receiving Growth Hormone Treatment|The denominator below (# at risk) is based on the number of subjects in Group 1 who received at least one dose of growth hormone.
1234419|NCT00140244|B1|Baseline|All Study Participants|"r-MetHuLeptin SubQ once daily~r-metHuLeptin/placebo then placebo/r-metHuLeptin"
1234420|NCT00140244|P2|Participant Flow|Placebo First, Then r-metHuLeptin|Subcutaneously once daily Placebo first, then r-metHuLeptin both at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
1234421|NCT00140244|P1|Participant Flow|r-MetHuLeptin First, Then Placebo|r-MetHuLeptin subcutaneously once daily first, then Placebo both at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
1234422|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
1234423|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
1234424|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
1234425|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
1234426|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
1234466|NCT00140231|O1|Outcome|Metreleptin|"r-metHuLeptin self-administered subcutaneously~r-metHuLeptin: recombinant human leptin"
1234428|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
1234429|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
1234430|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
1234431|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
1234432|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
1234433|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
1234434|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
1234435|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
1234436|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
1234437|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
1234438|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
1234439|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
1234440|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
1234441|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
1234442|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
1234443|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
1234516|NCT00139997|O2|Outcome|Inactive Intervention|Equivalent exposure to inactive negative ion generator
1234445|NCT00140244|O1|Outcome|r-metHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
1234446|NCT00140244|O2|Outcome|Placebo|Placebo at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
1234447|NCT00140244|O1|Outcome|r-MetHuLeptin|r-MetHuLeptin at a dose of 0.04 mg/kg/day divided into two equal doses, which were self-administered by sc injection at 0800 and 2000 h daily for 2 months.
1234448|NCT00140244|E2|Reported Event|Placebo|
1234449|NCT00140244|E1|Reported Event|r-MetHuLeptin|
1234450|NCT00140231|B3|Baseline|Total|Total of all reporting groups
1234451|NCT00140231|B2|Baseline|Iso Fed, Then Fasting w/ Placebo, Then Fasting w/ Metreleptin|"Placebo, administered in same method as active arm.~placebo: placebo (no active drug)"
1234452|NCT00140231|B1|Baseline|Iso Fed, Then Fasting w/ Metreleptin, Then Fasting w/ Placebo|"r-metHuLeptin self-administered subcutaneously~r-metHuLeptin: recombinant human leptin"
1234453|NCT00140231|P2|Participant Flow|Iso Fed, Then Fasting w/ Placebo, Then Fasting w/ Met|"Placebo, administered in same method as active arm.~placebo: placebo (no active drug)"
1234454|NCT00140231|P1|Participant Flow|Iso Fed, Then Fasting w/ Metreleptin, Then Fasting w/ Placebo|"Six young, healthy, and lean women (age, 22.8,; BMI,21.7kg/m2) who were eumenor- rheic were enrolled in a clinical researchcenter– based, randomized, cross-over interventional study involving three separate 5-day-long inpatient admissions (22). Six subjects with a cross-over design, enabling paired comparisons, would provide 80% power to detect a difference of 1.4 SD between different conditionsat the conventional~a=0.05 level. In thefirst admission, the subjects were studied in the isocaloric fed state, whereas in the following two admissions the subjects were studied in the prolonged fasting state for 72 h and were randomized to receive either placebo or metreleptin at replacement doses. A cross-over to the opposite arm took place in the later admission so that all six subjects received both placebo and metreleptin.~r-metHuLeptin self-administered subcutaneously~r-metHuLeptin: recombinant human leptin"
1234455|NCT00140231|O2|Outcome|Placebo|"Placebo, administered in same method as active arm.~placebo: placebo (no active drug)"
1234456|NCT00140231|O1|Outcome|Metreleptin|"r-metHuLeptin self-administered subcutaneously~r-metHuLeptin: recombinant human leptin"
1234457|NCT00140231|O2|Outcome|Placebo|"Placebo, administered in same method as active arm.~placebo: placebo (no active drug)"
1234458|NCT00140231|O1|Outcome|Metreleptin|"r-metHuLeptin self-administered subcutaneously~r-metHuLeptin: recombinant human leptin"
1234459|NCT00140231|O2|Outcome|Placebo|"Placebo, administered in same method as active arm.~placebo: placebo (no active drug)"
1234460|NCT00140231|O1|Outcome|Metreleptin|"r-metHuLeptin self-administered subcutaneously~r-metHuLeptin: recombinant human leptin"
1234461|NCT00140231|O2|Outcome|Placebo|"Placebo, administered in same method as active arm.~placebo: placebo (no active drug)"
1234462|NCT00140231|O1|Outcome|Metreleptin|"r-metHuLeptin self-administered subcutaneously~r-metHuLeptin: recombinant human leptin"
1234463|NCT00140231|O2|Outcome|Placebo|"Placebo, administered in same method as active arm.~placebo: placebo (no active drug)"
1234464|NCT00140231|O1|Outcome|Metreleptin|"r-metHuLeptin self-administered subcutaneously~r-metHuLeptin: recombinant human leptin"
1234465|NCT00140231|O2|Outcome|Placebo|"Placebo, administered in same method as active arm.~placebo: placebo (no active drug)"
1234468|NCT00140231|E1|Reported Event|Metreleptin|"r-metHuLeptin self-administered subcutaneously~r-metHuLeptin: recombinant human leptin"
1234469|NCT00140140|B4|Baseline|Total|Total of all reporting groups
1234470|NCT00140140|B3|Baseline|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
1234471|NCT00140140|B2|Baseline|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
1234472|NCT00140140|B1|Baseline|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
1234473|NCT00140140|P3|Participant Flow|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
1234474|NCT00140140|P2|Participant Flow|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
1234475|NCT00140140|P1|Participant Flow|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
1234476|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
1234477|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
1234478|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
1234479|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
1234480|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
1234481|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
1234482|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
1234483|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
1234484|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
1234485|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
1234486|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
1234487|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
1234488|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
1234489|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
1234490|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
1234491|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
1234492|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
1234493|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
1234517|NCT00139997|O1|Outcome|LED Phototherapy|Phototherapy with light-emitting diode phototherapy device
1234518|NCT00139997|O2|Outcome|Inactive Intervention|Equivalent exposure to inactive negative ion generator
1234494|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
1234495|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
1234496|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
1234497|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
1234498|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
1234499|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
1234500|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
1234501|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
1234502|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
1234503|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
1234504|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
1234505|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
1234506|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
1234507|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
1234508|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
1234509|NCT00140140|E2|Reported Event|90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants are from study Part 2.
1234510|NCT00140140|E1|Reported Event|80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants from study Parts 1 and 2 are combined.
1234511|NCT00139997|B3|Baseline|Total|Total of all reporting groups
1234512|NCT00139997|B2|Baseline|Inactive Intervention|Equivalent exposure to inactive negative ion generator
1234513|NCT00139997|B1|Baseline|LED Phototherapy|Phototherapy with light-emitting diode phototherapy device
1234514|NCT00139997|P2|Participant Flow|Inactive Intervention|Equivalent exposure to inactive negative ion generator
1234515|NCT00139997|P1|Participant Flow|LED Phototherapy|Phototherapy with light-emitting diode phototherapy device
1234523|NCT00139776|B2|Baseline|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
1234524|NCT00139776|B1|Baseline|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
1234525|NCT00139776|P4|Participant Flow|Celecoxib 200mg Intermittent Use|Period III Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
1234526|NCT00139776|P3|Participant Flow|Celecoxib 200mg Continuous Use|Period III Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
1234527|NCT00139776|P2|Participant Flow|Open-Label Celecoxib Run-in Period|Period II (14+/-2 days) run-in treatment with open label celecoxib to observe successful treatment of flare. Participants successfully treated randomized to 2 treatment groups in Period III (overall study).
1234528|NCT00139776|P1|Participant Flow|Wash-Out: Discontinue Non-Steroidal Anti-Inflammatories|Period I (14+/-2 days) wash out and discontinuation of non-steroidal anti-inflammatories (NSAIDs) leading to osteoarthritis (OA) flare.
1234529|NCT00139776|O1|Outcome|Celecoxib 200mg Open Label|Period II run-in (2 weeks). Celecoxib 200 mg daily until resolution of screening osteoarthritis flare as defined by IVRS
1234530|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
1234531|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
1234532|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
1234533|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
1234534|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
1234535|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
1234536|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
1234537|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
1234538|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
1234539|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
1234540|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
1234541|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
1234542|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
1234543|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
1234741|NCT00138424|B4|Baseline|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234544|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
1234545|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
1234546|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
1234547|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
1234548|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
1234549|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
1234550|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
1234551|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
1234552|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
1234553|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
1234554|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
1234555|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
1234556|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
1234557|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
1234558|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
1234559|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
1234560|NCT00139776|E2|Reported Event|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
1234561|NCT00139776|E1|Reported Event|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
1234562|NCT00139737|B1|Baseline|Ziprasidone|Ziprasidone treatment was continued at the same dose used in the previous protocol with subsequent dose adjustments within 20-40-60-80 mg twice daily according to investigator’s opinion on clinical status of subject. The maximum total daily oral dose allowed was 160 mg.
1234563|NCT00139737|P1|Participant Flow|Ziprasidone|Ziprasidone treatment was continued at the same dose used in the previous protocol with subsequent dose adjustments within 20-40-60-80 mg twice daily according to investigator’s opinion on clinical status of subject. The maximum total daily oral dose allowed was 160 mg.
1234564|NCT00139737|O1|Outcome|Ziprasidone|Ziprasidone treatment was continued at the same dose used in the previous protocol with subsequent dose adjustments within 20-40-60-80 mg twice daily according to investigator’s opinion on clinical status of subject. The maximum total daily oral dose allowed was 160 mg.
1234565|NCT00139737|E1|Reported Event|Ziprasidone|Ziprasidone treatment was continued at the same dose used in the previous protocol with subsequent dose adjustments within 20-40-60-80 mg twice daily according to investigator’s opinion on clinical status of subject. The maximum total daily oral dose allowed was 160 mg.
1234566|NCT00139659|B3|Baseline|Total|Total of all reporting groups
1234567|NCT00139659|B2|Baseline|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234568|NCT00139659|B1|Baseline|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234569|NCT00139659|P2|Participant Flow|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234570|NCT00139659|P1|Participant Flow|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234571|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234572|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234573|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234574|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234575|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234576|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234577|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234578|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234579|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234580|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234581|NCT00139659|O2|Outcome|Subcutaneous Insulin (Units/kg)|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234582|NCT00139659|O1|Outcome|Inhaled Insulin (mg/kg)|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234583|NCT00139659|O2|Outcome|Subcutaneous Insulin (Units)|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234584|NCT00139659|O1|Outcome|Inhaled Insulin (mg)|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234585|NCT00139659|O2|Outcome|Subcutaneous Insulin (Units/kg)|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234586|NCT00139659|O1|Outcome|Inhaled Insulin (mg/kg)|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234587|NCT00139659|O2|Outcome|Subcutaneous Insulin (Units)|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234588|NCT00139659|O1|Outcome|Inhaled Insulin (mg)|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234589|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234590|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234591|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234592|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234593|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234594|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234595|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234596|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234597|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234598|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234599|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234600|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234601|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234602|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234603|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234604|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234605|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234606|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234607|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234608|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234609|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234610|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234611|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234612|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234613|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234614|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234615|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234616|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234617|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234618|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234619|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234620|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234621|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234622|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234623|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234624|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234625|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234626|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234627|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234628|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234629|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234630|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234631|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234632|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234633|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234634|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234635|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234636|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234637|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234638|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234639|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234640|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234641|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234642|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234643|NCT00139659|E2|Reported Event|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234644|NCT00139659|E1|Reported Event|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234645|NCT00139477|B3|Baseline|Total|Total of all reporting groups
1234646|NCT00139477|B2|Baseline|Diet/Exercise Plus Metformin, Then Diet/Exercise Only|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period).
1234647|NCT00139477|B1|Baseline|Diet/Exercise Only, Then Diet/Exercise Plus Metformin|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period).
1234765|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234648|NCT00139477|P2|Participant Flow|Diet/Exercise Plus Metformin, Then Diet/Exercise Only|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period).
1234649|NCT00139477|P1|Participant Flow|Diet/Exercise Only, Then Diet/Exercise Plus Metformin|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period).
1234650|NCT00139477|O4|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Pubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
1234651|NCT00139477|O3|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Prepubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
1234652|NCT00139477|O2|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Pubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
1234653|NCT00139477|O1|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Prepubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
1234654|NCT00139477|O4|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Pubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
1234655|NCT00139477|O3|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Prepubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
1234656|NCT00139477|O2|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Pubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
1234657|NCT00139477|O1|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Prepubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
1234658|NCT00139477|O4|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Pubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
1234659|NCT00139477|O3|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Prepubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
1234660|NCT00139477|O2|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Pubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
1234661|NCT00139477|O1|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Prepubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
1234713|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234662|NCT00139477|O4|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Pubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
1234663|NCT00139477|O3|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Prepubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
1234664|NCT00139477|O2|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Pubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
1234665|NCT00139477|O1|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Prepubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
1234666|NCT00139477|E2|Reported Event|Diet/Exercise Plus Metformin, Then Diet/Exercise Only|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period).
1234667|NCT00139477|E1|Reported Event|Diet/Exercise Only, Then Diet/Exercise Plus Metformin|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period).
1234668|NCT00138671|B3|Baseline|Total|Total of all reporting groups
1234669|NCT00138671|B2|Baseline|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234670|NCT00138671|B1|Baseline|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234671|NCT00138671|P2|Participant Flow|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234672|NCT00138671|P1|Participant Flow|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234673|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234674|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234675|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234676|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234677|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234678|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234679|NCT00138671|O2|Outcome|Subcutaneous Insulin|
1234680|NCT00138671|O1|Outcome|Inhaled Insulin|
1234687|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234688|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234689|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234690|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234691|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234692|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234693|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234694|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234695|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234696|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234697|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234698|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234699|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234700|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234701|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234702|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234703|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234704|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234705|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234706|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234707|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234708|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234709|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234710|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234711|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234712|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234714|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234715|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234716|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234717|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234718|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234719|NCT00138671|E2|Reported Event|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234720|NCT00138671|E1|Reported Event|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234721|NCT00138658|B1|Baseline|OGX-011 - Intent to Treat Analysis Set|Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
1234722|NCT00138658|P1|Participant Flow|OGX-011 - Intent to Treat Analysis Set|Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
1234723|NCT00138658|O1|Outcome|Patients in Phase I Receiving 640 mg of OGX-011|Per protocol, ten subjects enrolled in the Phase I portion of the study. Three subjects received 480 mg; 6 subjects received 640 mg doses of OGX-011; and 1 patient discontinued prior to Cycle 1 Day 1 due to disease progression.
1234724|NCT00138658|O1|Outcome|Patients in Phase I Receiving 640 mg of OGX-011|Per protocol, ten subjects enrolled in the Phase I portion of the study. Three subjects received 480 mg; 6 subjects received 640 mg doses of OGX-011; and 1 patient discontinued prior to Cycle 1 Day 1 due to disease progression.
1234725|NCT00138658|O1|Outcome|OGX-011 - Intent to Treat Analysis Set|Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
1234726|NCT00138658|O1|Outcome|Patients in Phase I Receiving 640 mg of OGX-011|Per protocol, ten subjects enrolled in the Phase I portion of the study. Three subjects received 480 mg; 6 subjects received 640 mg doses of OGX-011; and 1 patient discontinued prior to Cycle 1 Day 1 due to disease progression.
1234727|NCT00138658|O1|Outcome|Mean Reduction in Serum Clusterin From Baseline|The mean reduction in serum clusterin was calculated by determining the difference from baseline to the minimum post baseline level. The reduction in serum clusterin was determined for all subjects who had baseline and at least one post-baseline serum clusterin assessment (n=55).
1234728|NCT00138658|O1|Outcome|OGX-011 - Intent to Treat Analysis Set|Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
1234729|NCT00138658|O1|Outcome|OGX-011 - Intent to Treat Analysis Set|Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
1234730|NCT00138658|E1|Reported Event|OGX-011 - Intent to Treat Analysis Set|Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
1234731|NCT00138645|B3|Baseline|Total|Total of all reporting groups
1234732|NCT00138645|B2|Baseline|Healthy Diet|Healthy Diet
1234733|NCT00138645|B1|Baseline|MicroDiet|MicroDiet
1234734|NCT00138645|P2|Participant Flow|Healthy Diet|Healthy Diet
1234735|NCT00138645|P1|Participant Flow|MicroDiet|MicroDiet
1234742|NCT00138424|B3|Baseline|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234743|NCT00138424|B2|Baseline|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234744|NCT00138424|B1|Baseline|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234745|NCT00138424|P4|Participant Flow|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234746|NCT00138424|P3|Participant Flow|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234747|NCT00138424|P2|Participant Flow|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234748|NCT00138424|P1|Participant Flow|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234749|NCT00138424|O2|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week - days 0, 7, 21, 35, 49)
1234750|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week - days 0, 7, 21, 35, 49)
1234751|NCT00138424|O2|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week - days 0, 7, 21, 35, 49)
1234752|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week - days 0, 7, 21, 35, 49)
1234753|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234754|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234755|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234756|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234757|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234758|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234759|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234760|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234761|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234762|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234763|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234764|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234766|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234767|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234768|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234769|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234770|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234771|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234772|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234773|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234774|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234775|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234776|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234777|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234778|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234779|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234780|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234781|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234782|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234783|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234784|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234785|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234786|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234787|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234788|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234789|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234790|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234791|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234792|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234793|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234794|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234795|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234796|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234797|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234798|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234799|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234800|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234801|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234802|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234803|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234804|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234805|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234806|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234807|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234808|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234809|NCT00138424|E4|Reported Event|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234810|NCT00138424|E3|Reported Event|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
1234811|NCT00138424|E2|Reported Event|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234812|NCT00138424|E1|Reported Event|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
1234813|NCT00138294|B1|Baseline|Intervention Cities|Eligible children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland with be offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program.
1234814|NCT00138294|P1|Participant Flow|Intervention Cities|Eligible children 4 years of age and older whose parents provided consent (assent for children>7 years) in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland) were offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program.
1234815|NCT00138294|O1|Outcome|Influenza Vaccine|Eligible children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland) were offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program. Serious adverse events (SAEs) and MAARI adverse events within 42 days post-LAIV vaccination were captured in seasonal and pandemic LAIV vaccinated study subjects in the intervention area.
1234816|NCT00138294|O2|Outcome|Comparison Cities|Children living in the comparison cities (Waco, Bryan and College Station) which are within 90 miles of the intervention cites received their influenza vaccines by the local healthcare providers. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.
1234817|NCT00138294|O1|Outcome|Intervention Cities|Eligible children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland were offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.
1234818|NCT00138294|O2|Outcome|Comparison Cities|Children living in the comparison cities (Waco, Bryan and College Station) which are within 90 miles of the intervention cites received their influenza vaccines by the local healthcare providers. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.
1234819|NCT00138294|O1|Outcome|Intervention Cities|Eligible children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland were offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.
1234820|NCT00138294|O2|Outcome|Comparison Cities|Children living in the comparison cities (Waco, Bryan and College Station) which are within 90 miles of the intervention cites received their influenza vaccines by the local healthcare providers. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.
1234821|NCT00138294|O1|Outcome|Intervention Cities|Eligible children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland were offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.
1234822|NCT00138294|E1|Reported Event|All Enrolled Study Participants|Children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland) with be offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program. Children living in the comparison cities (Waco, Bryan and College Station) which are within 90 miles of the intervention cites will received their influenza vaccines (live attenuated or inactivated influenza vaccines) by the local healthcare providers
1234823|NCT00138203|B1|Baseline|SAHA|Suberoylanilide Hydroxamic Acid (SAHA)
1234824|NCT00138203|P1|Participant Flow|SAHA|Suberoylanilide Hydroxamic Acid (SAHA), 400mg orally, once daily, in a 21 day cycle.
1234825|NCT00138203|O1|Outcome|SAHA|Suberoylanilide Hydroxamic Acid (SAHA)
1234826|NCT00138203|O1|Outcome|SAHA|Suberoylanilide Hydroxamic Acid (SAHA)
1234827|NCT00138203|O1|Outcome|SAHA|Suberoylanilide Hydroxamic Acid (SAHA)
1234828|NCT00138203|E1|Reported Event|SAHA|Suberoylanilide Hydroxamic Acid (SAHA)
1234829|NCT00138151|B1|Baseline|Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b|"Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle~Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle~Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days"
1234830|NCT00138151|P1|Participant Flow|Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b|"Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle~Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle~Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days"
1234831|NCT00138151|O1|Outcome|Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b|"Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle~Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle~Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days"
1234832|NCT00138151|O1|Outcome|Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b|"Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle~Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle~Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days"
1234833|NCT00138151|O1|Outcome|Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b|"Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle~Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle~Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days"
1234834|NCT00138151|E1|Reported Event|Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b|"Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle~Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle~Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days"
1235165|NCT00136760|O1|Outcome|CM + BUP|Contingent reinforcement plus bupropion
1234835|NCT00138125|B1|Baseline|Faslodex + Herceptin|"Faslodex : Administered IM at 500 mg on day 1 of cycle 1, followed by 500 mg on day 15 of cycle 1, then 500 mg on day 1 of each cycle thereafter.~Herceptin : Given at 4 mg/kg IV on day 1 (cycle 1) then 2mg/kg IV weekly"
1234836|NCT00138125|P1|Participant Flow|Faslodex + Herceptin|"Faslodex : Administered IM at 500 mg on day 1 of cycle 1, followed by 500 mg on day 15 of cycle 1, then 500 mg on day 1 of each cycle thereafter.~Herceptin : Given at 4 mg/kg IV on day 1 (cycle 1) then 2mg/kg IV weekly"
1234837|NCT00138125|O1|Outcome|Faslodex + Herceptin|"Faslodex : Administered IM at 500 mg on day 1 of cycle 1, followed by 500 mg on day 15 of cycle 1, then 500 mg on day 1 of each cycle thereafter.~Herceptin : Given at 4 mg/kg IV on day 1 (cycle 1) then 2mg/kg IV weekly"
1234838|NCT00138125|E1|Reported Event|Faslodex + Herceptin|"Faslodex : Administered IM at 500 mg on day 1 of cycle 1, followed by 500 mg on day 15 of cycle 1, then 500 mg on day 1 of each cycle thereafter.~Herceptin : Given at 4 mg/kg IV on day 1 (cycle 1) then 2mg/kg IV weekly"
1234839|NCT00138073|B1|Baseline|Web-based Waveform Interpretation Guide|"The arm has access to the Web-based waveform interpretation guide.~Web-based waveform interpretation guide: Use of an educational website."
1234840|NCT00138073|P1|Participant Flow|Web-based Waveform Interpretation Guide|"The arm has access to the Web-based waveform interpretation guide.~Web-based waveform interpretation guide: Use of an educational website."
1234841|NCT00138073|O1|Outcome|Web-based Waveform Interpretation Guide|"The arm has access to the Web-based waveform interpretation guide.~Web-based waveform interpretation guide: Use of an educational website."
1234842|NCT00138073|O1|Outcome|Web-based Waveform Interpretation Guide|"The arm has access to the Web-based waveform interpretation guide.~Web-based waveform interpretation guide: Use of an educational website."
1234843|NCT00138073|E1|Reported Event|Web-based Waveform Interpretation Guide|"The arm has access to the Web-based waveform interpretation guide.~Web-based waveform interpretation guide: Use of an educational website."
1234844|NCT00138034|B3|Baseline|Total|Total of all reporting groups
1234845|NCT00138034|B2|Baseline|Conservative Treatment|Conservative treatment of culprit lesion with dual antiplatelet therapy
1234846|NCT00138034|B1|Baseline|Percutaeous Coronary Intervention (PCI)|Stenting of culprit lesion followed by dual antiplatelet therapy
1234847|NCT00138034|P2|Participant Flow|Conservative Treatment|Conservative treatment of culprit lesion with dual antiplatelet therapy
1247977|NCT00098059|O3|Outcome|6 to <=12 Years|
1234848|NCT00138034|P1|Participant Flow|Percutaeous Coronary Intervention (PCI)|Stenting of culprit lesion followed by dual antiplatelet therapy
1234849|NCT00138034|O2|Outcome|Conservative Treatment|Conservative treatment of culprit lesion with dual antiplatelet therapy
1234850|NCT00138034|O1|Outcome|Percutaeous Coronary Intervention (PCI)|Stenting of culprit lesion followed by dual antiplatelet therapy
1234851|NCT00138034|O2|Outcome|Conservative Treatment|Conservative treatment of culprit lesion with dual antiplatelet therapy
1234852|NCT00138034|O1|Outcome|Percutaeous Coronary Intervention (PCI)|Stenting of culprit lesion followed by dual antiplatelet therapy
1234853|NCT00138034|E2|Reported Event|Conservative Treatment|Conservative treatment of culprit lesion with dual antiplatelet therapy
1234854|NCT00138034|E1|Reported Event|Percutaeous Coronary Intervention (PCI)|Stenting of culprit lesion followed by dual antiplatelet therapy
1234855|NCT00137969|B3|Baseline|Total|Total of all reporting groups
1234856|NCT00137969|B2|Baseline|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
1234857|NCT00137969|B1|Baseline|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
1234858|NCT00137969|P2|Participant Flow|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
1234859|NCT00137969|P1|Participant Flow|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
1234860|NCT00137969|O2|Outcome|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
1234861|NCT00137969|O1|Outcome|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
1234862|NCT00137969|O2|Outcome|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
1234863|NCT00137969|O1|Outcome|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
1234864|NCT00137969|O2|Outcome|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
1234865|NCT00137969|O1|Outcome|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
1234866|NCT00137969|O2|Outcome|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
1234867|NCT00137969|O1|Outcome|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
1234868|NCT00137969|O2|Outcome|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
1234869|NCT00137969|O1|Outcome|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
1234919|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234870|NCT00137969|O2|Outcome|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
1234871|NCT00137969|O1|Outcome|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
1234872|NCT00137969|O2|Outcome|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
1234873|NCT00137969|O1|Outcome|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
1234874|NCT00137969|O2|Outcome|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
1234875|NCT00137969|O1|Outcome|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
1234876|NCT00137969|E2|Reported Event|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
1234877|NCT00137969|E1|Reported Event|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
1234878|NCT00137631|B3|Baseline|Total|Total of all reporting groups
1234879|NCT00137631|B2|Baseline|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
1234880|NCT00137631|B1|Baseline|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
1234881|NCT00137631|P2|Participant Flow|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
1234882|NCT00137631|P1|Participant Flow|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
1234883|NCT00137631|O2|Outcome|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
1234884|NCT00137631|O1|Outcome|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
1234885|NCT00137631|O2|Outcome|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
1234886|NCT00137631|O1|Outcome|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
1234887|NCT00137631|O2|Outcome|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
1234888|NCT00137631|O1|Outcome|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
1234889|NCT00137631|O2|Outcome|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
1234890|NCT00137631|O1|Outcome|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
1234891|NCT00137631|O2|Outcome|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
1234892|NCT00137631|O1|Outcome|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
1234893|NCT00137631|E2|Reported Event|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
1234894|NCT00137631|E1|Reported Event|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
1234895|NCT00137449|B3|Baseline|Total|Total of all reporting groups
1234896|NCT00137449|B2|Baseline|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234897|NCT00137449|B1|Baseline|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234898|NCT00137449|P2|Participant Flow|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234945|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
1247978|NCT00098059|O2|Outcome|2 to <6 Years|
1234899|NCT00137449|P1|Participant Flow|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234900|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234901|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234902|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234903|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234904|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234905|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234906|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234907|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234908|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234909|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234910|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1235022|NCT00137046|B1|Baseline|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234911|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234912|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234913|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234914|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234915|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234916|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234917|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234918|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1235047|NCT00137046|O2|Outcome|Subcutaneous Insulin (Units/kg)|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234920|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234921|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234922|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234923|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234924|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234925|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234926|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234927|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234928|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234929|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234930|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234931|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234932|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234933|NCT00137449|E2|Reported Event|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234934|NCT00137449|E1|Reported Event|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
1234935|NCT00137436|B1|Baseline|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
1234936|NCT00137436|P1|Participant Flow|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|Sunitinib 37.5 milligrams (mg) plus (+) Docetaxel 75 mg per meters squared (mg/m^2) + Prednisone 5 mg given twice daily
1234937|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
1234938|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
1234939|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
1234940|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
1234941|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
1234942|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
1234943|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
1234944|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
1234946|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
1234947|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
1234948|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
1234949|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
1234950|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
1234951|NCT00137436|E1|Reported Event|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
1234952|NCT00137423|B3|Baseline|Total|Total of all reporting groups
1234953|NCT00137423|B2|Baseline|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
1234954|NCT00137423|B1|Baseline|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
1234955|NCT00137423|P2|Participant Flow|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
1234956|NCT00137423|P1|Participant Flow|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
1234957|NCT00137423|O2|Outcome|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
1235023|NCT00137046|P2|Participant Flow|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1234958|NCT00137423|O1|Outcome|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
1234959|NCT00137423|O2|Outcome|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
1234960|NCT00137423|O1|Outcome|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
1234961|NCT00137423|O2|Outcome|PM Dose Sunitinib Malate|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
1234962|NCT00137423|O1|Outcome|AM Dose Sunitinib Malate|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
1234963|NCT00137423|O2|Outcome|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
1234964|NCT00137423|O1|Outcome|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
1235048|NCT00137046|O1|Outcome|Inhaled Insulin (mg/kg)|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234965|NCT00137423|O2|Outcome|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
1234966|NCT00137423|O1|Outcome|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
1234967|NCT00137423|O2|Outcome|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
1234968|NCT00137423|O1|Outcome|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
1234969|NCT00137423|O2|Outcome|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
1234970|NCT00137423|O1|Outcome|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
1234971|NCT00137423|O2|Outcome|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
1234972|NCT00137423|O1|Outcome|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
1234973|NCT00137423|E2|Reported Event|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
1234974|NCT00137423|E1|Reported Event|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
1234975|NCT00137280|B3|Baseline|Total|Total of all reporting groups
1234976|NCT00137280|B2|Baseline|Usual Care|Continue with usual care
1234977|NCT00137280|B1|Baseline|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
1234978|NCT00137280|P2|Participant Flow|Usual Care|Continue with usual care
1234979|NCT00137280|P1|Participant Flow|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
1234980|NCT00137280|O2|Outcome|Usual Care|Continue with usual care
1234981|NCT00137280|O1|Outcome|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
1234982|NCT00137280|O2|Outcome|Usual Care|Continue with usual care
1235024|NCT00137046|P1|Participant Flow|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234983|NCT00137280|O1|Outcome|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
1234984|NCT00137280|O2|Outcome|Usual Care|Continue with usual care
1234985|NCT00137280|O1|Outcome|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
1234986|NCT00137280|O2|Outcome|Usual Care|Continue with usual care
1234987|NCT00137280|O1|Outcome|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
1234988|NCT00137280|E2|Reported Event|Usual Care|Continue with usual care
1234989|NCT00137280|E1|Reported Event|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
1234990|NCT00137267|B3|Baseline|Total|Total of all reporting groups
1234991|NCT00137267|B2|Baseline|Arm 2 - Health Education|"This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group.~Health Education: This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging."
1235049|NCT00137046|O2|Outcome|Subcutaneous Insulin (Units)|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1235050|NCT00137046|O1|Outcome|Inhaled Insulin (mg)|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1235051|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1235052|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234992|NCT00137267|B1|Baseline|Arm 1 - Time Limited Case Management (TLC)|"This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition.~Time limited case management: This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition."
1234993|NCT00137267|P2|Participant Flow|Health Education|"This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging.~Health Education: This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group."
1234994|NCT00137267|P1|Participant Flow|Time Limited Case Management|"This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition.~Time limited case management: This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition."
1234995|NCT00137267|O2|Outcome|Arm 2|"This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group.~Health Education: This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging."
1235025|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1235026|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1235027|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1235028|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1234996|NCT00137267|O1|Outcome|Arm 1|"This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition.~Time limited case management: This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition."
1234997|NCT00137267|O2|Outcome|Arm 2|"This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group.~Health Education: This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging."
1234998|NCT00137267|O1|Outcome|Arm 1|"This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition.~Time limited case management: This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition."
1234999|NCT00137267|E2|Reported Event|Arm 2|"This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group.~Health Education: This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging."
1235053|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1235054|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1235055|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1235056|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1235000|NCT00137267|E1|Reported Event|Arm 1|"This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition.~Time limited case management: This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition."
1235001|NCT00137111|B5|Baseline|Total|Total of all reporting groups
1235002|NCT00137111|B4|Baseline|Non Randomized|Patients not randomized for window study
1235003|NCT00137111|B3|Baseline|24 hr|24 hour High-Dose Methotrexate Infusion in upfront window treatment
1235004|NCT00137111|B2|Baseline|4 hr|4 hour High-Dose Methotrexate Infusion in upfront window treatment
1235005|NCT00137111|B1|Baseline|Total Therapy|Total therapy applies to all eligible patients and includes remission induction, consolidation, and continuation therapy.
1235006|NCT00137111|P4|Participant Flow|Non Randomized|Patients not randomized for window study
1235007|NCT00137111|P3|Participant Flow|24 hr|24 hour High-Dose Methotrexate Infusion in upfront window treatment
1235008|NCT00137111|P2|Participant Flow|4 hr|4 hour High-Dose Methotrexate Infusion in upfront window treatment
1235009|NCT00137111|P1|Participant Flow|Total Therapy|Total therapy applies to all eligible patients and includes remission induction, consolidation, and continuation therapy.
1235010|NCT00137111|O1|Outcome|Total Therapy|Total therapy applies to all eligible patients.
1235011|NCT00137111|O1|Outcome|Total Therapy|Total therapy applies to all eligible patients.
1235012|NCT00137111|O2|Outcome|24 hr|24 hour High-Dose Methotrexate Infusion in upfront window treatment
1235013|NCT00137111|O1|Outcome|4 hr|4 hour High-Dose Methotrexate Infusion in upfront window treatment
1235014|NCT00137111|O2|Outcome|24 hr|24 hour High-Dose Methotrexate Infusion in upfront window treatment
1235015|NCT00137111|O1|Outcome|4 hr|4 hour High-Dose Methotrexate Infusion in upfront window treatment
1235016|NCT00137111|O1|Outcome|Total Therapy|Total therapy applies to all eligible patients.
1235017|NCT00137111|O1|Outcome|Patients With High Risk of CNS Relapse|This is a subset of all patients enrolled. It is not a specific treatment arm.
1235018|NCT00137111|O1|Outcome|Total Therapy|Total therapy applies to all eligible patients.
1235019|NCT00137111|E1|Reported Event|Total Therapy|Total therapy applies to all eligible patients.
1235020|NCT00137046|B3|Baseline|Total|Total of all reporting groups
1235021|NCT00137046|B2|Baseline|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1235029|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1235030|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1235031|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1235032|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1235033|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1235034|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1235035|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1235036|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1235037|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1235038|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1235039|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1235040|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1235041|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1235042|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1235043|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1235044|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1235045|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1235046|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1235057|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1235058|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1235059|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1235060|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1235061|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1235062|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1235063|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1235064|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1235065|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1235066|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1235067|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1235068|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1235069|NCT00137046|E2|Reported Event|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
1235070|NCT00137046|E1|Reported Event|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
1235071|NCT00136955|B1|Baseline|Irinotecan/Cisplatin|Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
1235072|NCT00136955|P1|Participant Flow|Irinotecan/Cisplatin|Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
1235073|NCT00136955|O1|Outcome|Irinotecan/Cisplatin|Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
1235074|NCT00136955|O1|Outcome|Irinotecan/Cisplatin|Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
1235075|NCT00136955|O1|Outcome|Irinotecan/Cisplatin|Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
1235076|NCT00136955|O1|Outcome|Irinotecan/Cisplatin|Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
1235077|NCT00136955|E1|Reported Event|Irinotecan/Cisplatin|Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
1235078|NCT00136916|B3|Baseline|Total|Total of all reporting groups
1235079|NCT00136916|B2|Baseline|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
1235080|NCT00136916|B1|Baseline|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
1235081|NCT00136916|P2|Participant Flow|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
1235082|NCT00136916|P1|Participant Flow|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
1235083|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
1235084|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
1235085|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
1235086|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
1235087|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
1235088|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
1235089|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
1235225|NCT00135798|B4|Baseline|Total|Total of all reporting groups
1247979|NCT00098059|O1|Outcome|1 to < 2 Years|
1235090|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
1235091|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
1235092|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
1235093|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
1235094|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
1235095|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
1235096|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
1235097|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
1235098|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
1235099|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
1235100|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
1235101|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
1235102|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
1235103|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
1235104|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
1235105|NCT00136916|O2|Outcome|Subcutaneous Insulin (Units)|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
1235106|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®) (mg)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
1235107|NCT00136916|O2|Outcome|Subcutaneous Insulin (Units)|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
1235108|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®) (mg)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
1235109|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
1235110|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
1235111|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
1235112|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
1235113|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
1235226|NCT00135798|B3|Baseline|LADR Treatment: Genotypes 2 or 3|Patients in this subgroup were all assigned to LADR treatment.
1235114|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
1235115|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
1235116|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
1235117|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
1235118|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
1235119|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
1235120|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
1235121|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
1235122|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
1235123|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
1235124|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
1235125|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
1235126|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
1235127|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
1235128|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
1235129|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
1235130|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
1235131|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
1235132|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
1235133|NCT00136916|E2|Reported Event|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
1235134|NCT00136916|E1|Reported Event|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
1235135|NCT00136838|B1|Baseline|Study Participants|This is a within-group study design, all participant who completed the study completed 2 phases of treatment, done in random order, each lasting 5 days and separated by at least 2 weeks. During one of the phases participants were exposed to active cigarette cues (pack of cigarettes, smoke) and during the other phase they were exposed to sham control cues (water bottle and the glass)
1235136|NCT00136838|P2|Participant Flow|Active Cue First, Then Neutral Cue|"Each participant receives two consecutive interventions in random order.~Cigarette cue: during this phase of treatment participants were presented with active cigarette cue~Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue"
1235227|NCT00135798|B2|Baseline|LADR Treatment: Genotypes 1, 4, 6|Low Accelerating Dose Regimen (LADR): Subjects randomized to LADR treatment group 2:1 compared to standard care.
1235680|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
1235137|NCT00136838|P1|Participant Flow|Neutral Cue First, Then Active Cue|"Participants receives two consecutive interventions in random order.~Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue~Cigarette cue: during this phase of treatment participants were presented with active cigarette cue"
1235138|NCT00136838|O2|Outcome|Neutral Cue Craving|intensity of craving following cue exposure
1235139|NCT00136838|O1|Outcome|Active Cue Craving|intensity of craving following cue exposure
1235140|NCT00136838|O2|Outcome|Neutral Cue|During this phase of study participants were exposed to a neutral (sham) cue: a bottle of water and a glass
1235141|NCT00136838|O1|Outcome|Active Cue|During this phase participants were exposed to active cigarette cues: pack of cigarettes and a cigarette smoke
1235142|NCT00136838|E2|Reported Event|Active Cue|1.Cigarette cue: during this phase of treatment participants were presented with active cigarette cue.
1235143|NCT00136838|E1|Reported Event|Neutral Cue|Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue
1235144|NCT00136812|B3|Baseline|Total|Total of all reporting groups
1235145|NCT00136812|B2|Baseline|Brief Treatment|The intervention included a Transtheoretical Model-tailored computerized program and print workbook; brief on-unit counseling session; and nicotine replacement therapy (NRT) during hospitalization with access to 10 weeks of NRT post-hospitalization.
1235146|NCT00136812|B1|Baseline|Control|Usual care provided NRT during hospitalization with brief cessation advice.
1235147|NCT00136812|P2|Participant Flow|Brief Treatment|The intervention included a Transtheoretical Model-tailored computerized program and print workbook; brief on-unit counseling session; and nicotine replacement therapy (NRT) during hospitalization with access to 10 weeks of NRT post-hospitalization.
1235148|NCT00136812|P1|Participant Flow|Control|Usual care provided NRT during hospitalization with brief cessation advice.
1235149|NCT00136812|O2|Outcome|Brief Treatment|The intervention included a Transtheoretical Model-tailored computerized program and print workbook; brief on-unit counseling session; and nicotine replacement therapy (NRT) during hospitalization with access to 10 weeks of NRT post-hospitalization.
1235150|NCT00136812|O1|Outcome|Control|Usual care provided NRT during hospitalization with brief cessation advice.
1235151|NCT00136812|E2|Reported Event|2: Intervention|"intervention~Tobacco Use Cessation: This intervention consists of nicotine patch therapy during hospitalization; a stage-based self-help manual; an individualized, expert-system, feedback report at intake, 3 months and 6 months post-hospitalization with carbon copies sent to participants' outpatient clinicians; and an individual 30-min smoking cessation counseling sessions during hospitalization. Additionally, up to 10 weeks of nicotine patch is provided to intervention participants intending to stay quit following hospital discharge."
1235152|NCT00136812|E1|Reported Event|1: Enhanced Standard Care Control|enhanced standard care control
1235153|NCT00136760|B5|Baseline|Total|Total of all reporting groups
1235154|NCT00136760|B4|Baseline|NR + PLA|Non-contingent reinforcement plus placebo
1235155|NCT00136760|B3|Baseline|NR + BUP|Non-contingent reinforcement plus bupropion
1235156|NCT00136760|B2|Baseline|CM + PLA|Contingent reinforcement plus placebo
1235157|NCT00136760|B1|Baseline|CM + BUP|Contingent reinforcement plus bupropion
1235158|NCT00136760|P4|Participant Flow|NR + PLA|Non-contingent reinforcement plus placebo
1235159|NCT00136760|P3|Participant Flow|NR + BUP|Non-contingent reinforcement plus bupropion
1235160|NCT00136760|P2|Participant Flow|CM + PLA|Contingent reinforcement plus placebo
1235161|NCT00136760|P1|Participant Flow|CM + BUP|Contingent reinforcement plus bupropion
1235162|NCT00136760|O4|Outcome|NR + PLA|Non-contingent reinforcement plus placebo
1235163|NCT00136760|O3|Outcome|NR + BUP|Non-contingent reinforcement plus bupropion
1235164|NCT00136760|O2|Outcome|CM + PLA|Contingent reinforcement plus placebo
1235166|NCT00136760|O4|Outcome|NR + PLA|Non-contingent reinforcement plus placebo
1235167|NCT00136760|O3|Outcome|NR + BUP|Non-contingent reinforcement plus bupropion
1235168|NCT00136760|O2|Outcome|CM + PLA|Contingent reinforcement plus placebo
1235169|NCT00136760|O1|Outcome|CM + BUP|Contingent reinforcement plus bupropion
1235170|NCT00136760|E4|Reported Event|NR + PLA|Non-contingent reinforcement plus placebo
1235171|NCT00136760|E3|Reported Event|NR + BUP|Non-contingent reinforcement plus bupropion
1235172|NCT00136760|E2|Reported Event|CM + PLA|Contingent reinforcement plus placebo
1235173|NCT00136760|E1|Reported Event|CM + BUP|Contingent reinforcement plus bupropion
1235174|NCT00136695|B3|Baseline|Total|Total of all reporting groups
1235175|NCT00136695|B2|Baseline|Placebo|"placebo~anastrozole: 1 mg QD"
1235176|NCT00136695|B1|Baseline|Anastrozole|"anastrozole~anastrozole: 1 mg QD"
1235177|NCT00136695|P2|Participant Flow|Placebo|"placebo~anastrozole: 1 mg QD"
1235178|NCT00136695|P1|Participant Flow|Anastrozole|"anastrozole~anastrozole: 1 mg QD"
1235179|NCT00136695|O2|Outcome|Placebo|"placebo~anastrozole: 1 mg QD"
1235180|NCT00136695|O1|Outcome|Anastrozole|"anastrozole~anastrozole: 1 mg QD"
1235181|NCT00136695|E2|Reported Event|Placebo|"placebo~anastrozole: 1 mg QD"
1235182|NCT00136695|E1|Reported Event|Anastrozole|"anastrozole~anastrozole: 1 mg QD"
1235183|NCT00136357|B3|Baseline|Total|Total of all reporting groups
1235184|NCT00136357|B2|Baseline|Delayed Intervention|Comparison group not receiving intervention until after the initial intervention was completed.
1235185|NCT00136357|B1|Baseline|Mind-Body Skills Groups|12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques.
1235186|NCT00136357|P2|Participant Flow|Delayed Intervention|Comparison group not receiving intervention until after the initial intervention was completed.
1235187|NCT00136357|P1|Participant Flow|Mind-Body Skills Groups|12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques.
1235188|NCT00136357|O2|Outcome|Delayed Intervention|Comparison group not receiving intervention until after the initial intervention was completed.
1235681|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
1235189|NCT00136357|O1|Outcome|Mind-Body Skills Groups|"12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques.~Mind-Body Skills Groups: 12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques."
1235190|NCT00136357|E2|Reported Event|Delayed Intervention|Comparison group not receiving intervention until after the initial intervention was completed.
1235191|NCT00136357|E1|Reported Event|Mind-Body Skills Groups|"12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques.~Mind-Body Skills Groups: 12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques."
1235192|NCT00136318|B3|Baseline|Total|Total of all reporting groups
1235193|NCT00136318|B2|Baseline|Placebo|"After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.~Peginterferon alfa-2a :~Placebo :~Ribavirin :"
1235194|NCT00136318|B1|Baseline|Escitalopram|"After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.~Peginterferon alfa-2a :~Escitalopram :~Ribavirin :"
1235195|NCT00136318|P2|Participant Flow|Placebo|"After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.~Peginterferon alfa-2a :~Placebo :~Ribavirin :"
1235196|NCT00136318|P1|Participant Flow|Escitalopram|"After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.~Peginterferon alfa-2a :~Escitalopram :~Ribavirin :"
1235197|NCT00136318|O2|Outcome|Placebo|"After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.~Peginterferon alfa-2a :~Placebo :~Ribavirin :"
1235198|NCT00136318|O1|Outcome|Escitalopram|"After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.~Peginterferon alfa-2a :~Escitalopram :~Ribavirin :"
1235199|NCT00136318|O2|Outcome|Placebo|"After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.~Peginterferon alfa-2a :~Placebo :~Ribavirin :"
1235200|NCT00136318|O1|Outcome|Escitalopram|"After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.~Peginterferon alfa-2a :~Escitalopram :~Ribavirin :"
1235201|NCT00136318|O2|Outcome|Placebo|"After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.~Peginterferon alfa-2a :~Placebo :~Ribavirin :"
1235202|NCT00136318|O1|Outcome|Escitalopram|"After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.~Peginterferon alfa-2a :~Escitalopram :~Ribavirin :"
1235352|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
1235203|NCT00136318|O2|Outcome|Placebo|"After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.~Peginterferon alfa-2a :~Placebo :~Ribavirin :"
1235204|NCT00136318|O1|Outcome|Escitalopram|"After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.~Peginterferon alfa-2a :~Escitalopram :~Ribavirin :"
1235205|NCT00136318|O2|Outcome|Placebo|"After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.~Peginterferon alfa-2a :~Placebo :~Ribavirin :"
1235206|NCT00136318|O1|Outcome|Escitalopram|"After the preobservation period, patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.~Peginterferon alfa-2a :~Escitalopram :~Ribavirin :"
1235207|NCT00136318|E2|Reported Event|Placebo|
1235208|NCT00136318|E1|Reported Event|Escitalopram|
1235209|NCT00136084|B3|Baseline|Total|Total of all reporting groups
1235210|NCT00136084|B2|Baseline|Arm 2:(LDAC)|Low-dose Cytarabine (LDAC)
1235211|NCT00136084|B1|Baseline|Arm 1: (HDAC)|High-dose Cytarabine (HDAC)
1235212|NCT00136084|P2|Participant Flow|Arm 2:(LDAC)|Low-dose Cytarabine (LDAC)
1235213|NCT00136084|P1|Participant Flow|Arm 1: (HDAC)|High-dose Cytarabine (HDAC)
1235214|NCT00136084|O1|Outcome|Overall|17 of the 232 eligible patients
1235215|NCT00136084|O2|Outcome|Arm 2:(LDAC)|Low-dose Cytarabine (Ara-C) (LDAC)
1235216|NCT00136084|O1|Outcome|Arm 1: (HDAC)|High-dose Cytarabine (Ara-C) (HDAC)
1235217|NCT00136084|O1|Outcome|Overall|Evaluation of all study participants
1235218|NCT00136084|O1|Outcome|Overall|Post-GO Treatment MRD
1235219|NCT00136084|O1|Outcome|Overall|Patients who have no response to one course of induction therapy
1235220|NCT00136084|O1|Outcome|Overall|Post-GO Treatment MRD
1235221|NCT00136084|O2|Outcome|Arm 2:(LDAC)|Low-dose Cytarabine (LDAC)
1235222|NCT00136084|O1|Outcome|Arm 1: (HDAC)|High-dose Cytarabine (HDAC)
1235223|NCT00136084|E2|Reported Event|Arm 2:(LDAC)|Low-dose Cytarabine (LDAC)
1235224|NCT00136084|E1|Reported Event|Arm 1: (HDAC)|High-dose Cytarabine (HDAC)
1235228|NCT00135798|B1|Baseline|Standard Clinical Care: Genotypes 1, 4, 6|Subjects randomized to non-treatment group 1:2 compared to treatment group.
1235229|NCT00135798|P3|Participant Flow|LADR Treatment: Genotypes 2 or 3|Patients in this subgroup were all assigned to LADR treatment.
1235230|NCT00135798|P2|Participant Flow|LADR Treatment: Genotypes 1, 4, 6|Low Accelerating Dose Regimen (LADR): Subjects randomized to LADR treatment group 2:1 compared to standard care.
1235231|NCT00135798|P1|Participant Flow|Standard Clinical Care: Genotypes 1, 4, 6|Subjects randomized to non-treatment group 1:2 compared to treatment group.
1235232|NCT00135798|O3|Outcome|LADR Treatment Group: Genotypes 2, 3|All patients with Genotypes 2,3 received LADR treatment.
1235233|NCT00135798|O2|Outcome|LADR Treatment Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
1235234|NCT00135798|O1|Outcome|Standard Care Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
1235235|NCT00135798|O3|Outcome|LADR Treatment Group: Genotypes 2, 3|All patients with Genotypes 2,3 received LADR treatment.
1235236|NCT00135798|O2|Outcome|LADR Treatment Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
1235237|NCT00135798|O1|Outcome|Standard Care Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
1235238|NCT00135798|O3|Outcome|LADR Treatment Group: Genotypes 2, 3|All patients with Genotypes 2,3 received LADR treatment.
1235239|NCT00135798|O2|Outcome|LADR Treatment Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
1235240|NCT00135798|O1|Outcome|Standard Care Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
1235241|NCT00135798|O3|Outcome|LADR Treatment Group: Genotypes 2, 3|All patients with Genotypes 2,3 received LADR treatment.
1235242|NCT00135798|O2|Outcome|LADR Treatment Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
1235243|NCT00135798|O1|Outcome|Standard Care Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
1235244|NCT00135798|E2|Reported Event|LADR Treatment (All Genotypes)|This group combines all who received LADR treatment (Per Protocol analysis) for all Genotypes 1,4,6 and 2,3
1235245|NCT00135798|E1|Reported Event|Standard Clinical Care: Genotypes 1, 4, 6|Subjects who received no LADR treatment (Per Protocol analysis)
1235246|NCT00135694|B4|Baseline|Total|Total of all reporting groups
1235247|NCT00135694|B3|Baseline|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
1235248|NCT00135694|B2|Baseline|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
1235249|NCT00135694|B1|Baseline|Terminated Prior to Randomization|Subjects enrolled and transplanted into the trial but not eligible for randomization.
1235250|NCT00135694|P3|Participant Flow|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
1235251|NCT00135694|P2|Participant Flow|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
1235252|NCT00135694|P1|Participant Flow|Terminated Prior to Randomization|Subjects enrolled and transplanted into the trial but not eligible for randomization.
1235253|NCT00135694|O2|Outcome|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
1235254|NCT00135694|O1|Outcome|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
1235255|NCT00135694|O2|Outcome|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
1235256|NCT00135694|O1|Outcome|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
1235257|NCT00135694|O2|Outcome|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
1235258|NCT00135694|O1|Outcome|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
1235259|NCT00135694|O2|Outcome|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
1235260|NCT00135694|O1|Outcome|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
1235261|NCT00135694|O1|Outcome|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
1235262|NCT00135694|O1|Outcome|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
1235263|NCT00135694|O1|Outcome|All Enrolled|Subjects who underwent liver transplantation in the trial.
1235264|NCT00135694|O2|Outcome|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
1235265|NCT00135694|O1|Outcome|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
1235682|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
1235266|NCT00135694|E3|Reported Event|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
1235267|NCT00135694|E2|Reported Event|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
1235268|NCT00135694|E1|Reported Event|Terminated Prior to Randomization|Subjects enrolled and transplanted into the trial but not eligible for randomization.
1235269|NCT00135356|B3|Baseline|Total|Total of all reporting groups
1235270|NCT00135356|B2|Baseline|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
1235271|NCT00135356|B1|Baseline|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
1235272|NCT00135356|P2|Participant Flow|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
1235273|NCT00135356|P1|Participant Flow|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
1235274|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
1235275|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
1235276|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
1235277|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
1235278|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
1235279|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
1235280|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
1235281|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
1235427|NCT00134784|B3|Baseline|Levodopa 300 mg/Day|Subjects on 300 mg/day of Levodopa
1235282|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
1235283|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
1235284|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
1235285|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
1235286|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
1235287|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
1235288|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
1235289|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
1235290|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
1235291|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
1235324|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
1235292|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
1235293|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
1235294|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
1235295|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
1235296|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
1235297|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
1235298|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
1235299|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
1235300|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
1235301|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
1235302|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
1235303|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
1235304|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
1235305|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
1235306|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
1235307|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
1235308|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
1235309|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
1235310|NCT00135356|E2|Reported Event|PI/RTV Control Arm|
1235311|NCT00135356|E1|Reported Event|ATV/RTV Switch Arm|
1235312|NCT00135330|B4|Baseline|Total|Total of all reporting groups
1235313|NCT00135330|B3|Baseline|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
1235314|NCT00135330|B2|Baseline|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
1235315|NCT00135330|B1|Baseline|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
1235316|NCT00135330|P3|Participant Flow|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
1235317|NCT00135330|P2|Participant Flow|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
1235318|NCT00135330|P1|Participant Flow|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
1235319|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
1235320|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
1235321|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
1235322|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
1235323|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
1235325|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
1235326|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
1235327|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
1235328|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
1235329|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
1235330|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
1235331|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
1235332|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
1235333|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
1235334|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
1235335|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
1235336|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
1235337|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
1235338|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
1235339|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
1235340|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
1235341|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
1235342|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
1235343|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
1235344|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
1235345|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
1235346|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
1235347|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
1235348|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
1235349|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
1235350|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
1235351|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
1235353|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
1235354|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
1235355|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
1235356|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
1235357|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
1235358|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
1235359|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
1235360|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
1235361|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
1235362|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
1235363|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
1235364|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
1235365|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
1235366|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
1235367|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
1235368|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
1235369|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
1235370|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
1235371|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
1235372|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
1235373|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
1235374|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
1235375|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
1235376|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
1235377|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
1235378|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
1235379|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
1235380|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
1235381|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
1235382|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
1235383|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
1235384|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
1235385|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
1235386|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
1235387|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
1235388|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
1235389|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
1235390|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
1235391|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
1235392|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
1235393|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
1235394|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
1235395|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
1235396|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
1235397|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
1235428|NCT00134784|B2|Baseline|Levodopa 150mg/Day|Subjects on 150mg/day of Levodopa
1235398|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
1235399|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
1235400|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
1235401|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
1235402|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
1235403|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
1235404|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
1235405|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
1235406|NCT00135330|E3|Reported Event|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
1235407|NCT00135330|E2|Reported Event|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
1235408|NCT00135330|E1|Reported Event|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
1235409|NCT00135200|B1|Baseline|Bexxar Therapeutic|"The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the dosimetric infusion and the therapeutic infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose."
1235446|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235683|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
1235410|NCT00135200|P1|Participant Flow|Bexxar Therapeutic|"The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the dosimetric infusion and the therapeutic infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose."
1235411|NCT00135200|O1|Outcome|Bexxar Therapeutic|"The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the dosimetric infusion and the therapeutic infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose."
1235412|NCT00135200|O1|Outcome|Bexxar Therapeutic|"The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the dosimetric infusion and the therapeutic infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose."
1235413|NCT00135200|E1|Reported Event|Bexxar Therapeutic|"The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the dosimetric infusion and the therapeutic infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose."
1235414|NCT00134901|B3|Baseline|Total|Total of all reporting groups
1235415|NCT00134901|B2|Baseline|Placebo|Placebo daily dose
1235416|NCT00134901|B1|Baseline|Memantine|Memantine 40mg/day
1235417|NCT00134901|P2|Participant Flow|Placebo|Placebo daily dose
1235418|NCT00134901|P1|Participant Flow|Memantine|Memantine 40mg/day
1235419|NCT00134901|O2|Outcome|Placebo|"Placebo~placebo: placebo"
1235420|NCT00134901|O1|Outcome|Memantine|"Memantine~Memantine: Memantine"
1235421|NCT00134901|O2|Outcome|Placebo|Placebo daily dose
1235422|NCT00134901|O1|Outcome|Memantine|Memantine 40mg/day
1235423|NCT00134901|E2|Reported Event|Placebo|Placebo daily dose
1235424|NCT00134901|E1|Reported Event|Memantine|Memantine 40mg/day
1235425|NCT00134784|B5|Baseline|Total|Total of all reporting groups
1235426|NCT00134784|B4|Baseline|Levodopa 600 mg/Day|Subjects on Levodopa 600 mg/day
1235430|NCT00134784|P4|Participant Flow|Levodopa 600 mg/Day|Levodopa 600/day, [123I]ß-CIT and SPECT imaging
1235431|NCT00134784|P3|Participant Flow|Levodopa 300 mg/Day|Levodopa 300mg/day, [123I]ß-CIT and SPECT imaging
1235432|NCT00134784|P2|Participant Flow|Levodopa 150mg/Day|Levodopa 150mg/day, [123I]ß-CIT and SPECT imaging
1235433|NCT00134784|P1|Participant Flow|Placebo|Placebo group
1235434|NCT00134784|O4|Outcome|Levodopa 3|Subjects on 600 mg/day of Levodopa
1235435|NCT00134784|O3|Outcome|Levodopa 2|Subjects on 300 mg/day of Levodopa
1235436|NCT00134784|O2|Outcome|Levodopa|Subjects on 150 mg/day of Levodopa
1235437|NCT00134784|O1|Outcome|Placebo Group|Participants receiving placebo
1235438|NCT00134784|E1|Reported Event|I123BCIT|[123I]ß CIT and SPECT imaging' .
1235439|NCT00134719|B4|Baseline|Total|Total of all reporting groups
1235440|NCT00134719|B3|Baseline|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235441|NCT00134719|B2|Baseline|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235442|NCT00134719|B1|Baseline|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235443|NCT00134719|P3|Participant Flow|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235444|NCT00134719|P2|Participant Flow|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235445|NCT00134719|P1|Participant Flow|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235684|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
1235447|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235448|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235449|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235450|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235451|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235452|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235453|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235454|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235455|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235456|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235457|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235458|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235459|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235460|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235461|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235462|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235463|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235581|NCT00134563|O1|Outcome|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
1235582|NCT00134563|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
1235464|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235465|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235466|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235467|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235468|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235469|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235470|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235471|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235472|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235473|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235474|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235475|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235476|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235477|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235478|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235479|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235480|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235481|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235482|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235483|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235484|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235485|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235486|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235487|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235488|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235489|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235490|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235491|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235492|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235493|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235494|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235495|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235496|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235497|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235498|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235499|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235500|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235501|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235502|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235503|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235504|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235505|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235506|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235507|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235508|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235509|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235510|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235511|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235512|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235513|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235514|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235515|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235516|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235517|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235518|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235519|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235520|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235521|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235522|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235523|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235524|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235525|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235526|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235527|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235528|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235529|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235530|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235531|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235532|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235533|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235534|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235535|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235536|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235537|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235538|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235539|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235540|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235541|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235542|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235543|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235544|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235545|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235546|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235547|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235548|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235549|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235550|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235551|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235552|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235553|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235554|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235555|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235556|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235557|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235558|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235559|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235560|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235561|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235562|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235563|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235564|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235565|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235566|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235567|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235568|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235569|NCT00134719|E3|Reported Event|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
1235570|NCT00134719|E2|Reported Event|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235571|NCT00134719|E1|Reported Event|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
1235572|NCT00134563|B4|Baseline|Total|Total of all reporting groups
1235573|NCT00134563|B3|Baseline|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
1235574|NCT00134563|B2|Baseline|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
1235575|NCT00134563|B1|Baseline|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
1235576|NCT00134563|P3|Participant Flow|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
1235577|NCT00134563|P2|Participant Flow|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
1235578|NCT00134563|P1|Participant Flow|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
1235579|NCT00134563|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
1235580|NCT00134563|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
1235658|NCT00133978|O2|Outcome|Antioxidants|Antioxidant supplementation
1235583|NCT00134563|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
1235584|NCT00134563|O1|Outcome|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
1235585|NCT00134563|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
1235586|NCT00134563|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
1235587|NCT00134563|O1|Outcome|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
1235588|NCT00134563|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
1235589|NCT00134563|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
1235590|NCT00134563|O1|Outcome|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
1235591|NCT00134563|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
1235592|NCT00134563|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
1235593|NCT00134563|O1|Outcome|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
1235594|NCT00134563|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
1235595|NCT00134563|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
1235596|NCT00134563|O1|Outcome|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
1235597|NCT00134563|E3|Reported Event|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
1235598|NCT00134563|E2|Reported Event|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
1235599|NCT00134563|E1|Reported Event|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
1235600|NCT00134056|B3|Baseline|Total|Total of all reporting groups
1235601|NCT00134056|B2|Baseline|Arm II: Atrasentan|"Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.~atrasentan hydrochloride: Given orally~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally"
1235685|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
1235686|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
1235602|NCT00134056|B1|Baseline|Arm I: Placebo|"Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally~placebo: Given orally"
1235603|NCT00134056|P2|Participant Flow|Arm II: Atrasentan|"Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.~atrasentan hydrochloride: Given orally~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally"
1235604|NCT00134056|P1|Participant Flow|Arm I: Placebo|"Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally~placebo: Given orally"
1235605|NCT00134056|O2|Outcome|Arm II: Atrasentan Hydrochloride|"Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.~atrasentan hydrochloride: Given orally~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally"
1235606|NCT00134056|O1|Outcome|Arm I: Placebo|"Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally~placebo: Given orally"
1235607|NCT00134056|O2|Outcome|Arm II: Atrasentan|"Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.~atrasentan hydrochloride: Given orally~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally"
1235608|NCT00134056|O1|Outcome|Arm I: Placebo|"Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally~placebo: Given orally"
1235609|NCT00134056|O2|Outcome|Arm II: Atrasentan|"Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.~atrasentan hydrochloride: Given orally~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally"
1235610|NCT00134056|O1|Outcome|Arm I: Placebo|"Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally~placebo: Given orally"
1235659|NCT00133978|O1|Outcome|Glutamine|Glutamine supplementation
1235660|NCT00133978|O4|Outcome|Placebo|Non-isonitrogenic, iso-caloric placebo solution
1235661|NCT00133978|O3|Outcome|Glutamine + Antioxidants|Glutamine and antioxidant supplementation
1235611|NCT00134056|O2|Outcome|Arm II: Atrasentan|"Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.~atrasentan hydrochloride: Given orally~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally"
1235612|NCT00134056|O1|Outcome|Arm I: Placebo|"Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally~placebo: Given orally"
1235613|NCT00134056|O2|Outcome|Arm II: Atrasentan|Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.
1235614|NCT00134056|O1|Outcome|Arm I: Placebo|Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.
1235615|NCT00134056|O2|Outcome|Arm II: Atrasentan|"Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.~atrasentan hydrochloride: Given orally~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally"
1235616|NCT00134056|O1|Outcome|Arm I: Placebo|"Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally~placebo: Given orally"
1235633|NCT00134004|O1|Outcome|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
1235617|NCT00134056|O2|Outcome|Arm II: Atrasentan|"Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.~atrasentan hydrochloride: Given orally~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally"
1235618|NCT00134056|O1|Outcome|Arm I: Placebo|"Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally~placebo: Given orally"
1235619|NCT00134056|O2|Outcome|Arm II: Atrasentan|"Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.~atrasentan hydrochloride: Given orally~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally"
1235620|NCT00134056|O1|Outcome|Arm I: Placebo|"Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally~placebo: Given orally"
1235621|NCT00134056|E2|Reported Event|Arm II: Atrasentan|Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.
1235622|NCT00134056|E1|Reported Event|Arm I: Placebo|Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.
1235623|NCT00134043|B3|Baseline|Total|Total of all reporting groups
1235624|NCT00134043|B2|Baseline|MTC (Medullary Thyroid Cancer)|"Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.~vorinostat: Given orally"
1235625|NCT00134043|B1|Baseline|DTCs (Well-differentiated Thyroid Carcinomas)|"Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.~vorinostat: Given orally"
1235626|NCT00134043|P2|Participant Flow|MTC (Medullary Thyroid Cancer)|"Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.~vorinostat: Given orally"
1235627|NCT00134043|P1|Participant Flow|DTCs (Well-differentiated Thyroid Carcinomas)|"Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.~vorinostat: Given orally"
1235628|NCT00134043|O2|Outcome|MTC (Medullary Thyroid Cancer)|"Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.~vorinostat: Given orally"
1235629|NCT00134043|O1|Outcome|DTCs (Well-differentiated Thyroid Carcinomas)|Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.
1235630|NCT00134043|E1|Reported Event|Arm I & Arm II|"Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.~vorinostat: Given orally"
1235631|NCT00134004|B1|Baseline|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
1235632|NCT00134004|P1|Participant Flow|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
1235679|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
1235634|NCT00134004|O1|Outcome|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
1235635|NCT00134004|O1|Outcome|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
1235636|NCT00134004|O1|Outcome|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
1235637|NCT00134004|O1|Outcome|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
1235638|NCT00134004|E1|Reported Event|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
1235639|NCT00133978|B5|Baseline|Total|Total of all reporting groups
1235640|NCT00133978|B4|Baseline|Placebo|Non-isonitrogenic, iso-caloric placebo solution
1235641|NCT00133978|B3|Baseline|Glutamine + Antioxidants|Glutamine and antioxidant supplementation
1235642|NCT00133978|B2|Baseline|Antioxidants|Antioxidant supplementation
1235643|NCT00133978|B1|Baseline|Glutamine|Glutamine supplementation
1235644|NCT00133978|P4|Participant Flow|Placebo|Non-isonitrogenic, iso-caloric placebo solution
1235645|NCT00133978|P3|Participant Flow|Glutamine + Antioxidants|"Glutamine and antioxidant supplementation 0.35 g/kg/day of glutamine intravenously based on ideal body weight, provided as 0.50 g/kg/day of the dipeptide alanyl-glutamine and 30 g/day enterally, provided as alanyl-glutamine and glycine-glutamine dipeptides.~500 ug of selenium intravenously , and the following vitamins and minerals enterally-- selenium 300 g, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg."
1235646|NCT00133978|P2|Participant Flow|Antioxidants|Antioxidant supplementation 500 ug of selenium intravenously, and the following vitamins and minerals enterally-- selenium 300 g, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg.
1235647|NCT00133978|P1|Participant Flow|Glutamine|Glutamine supplementation 0.35 g/kg/day of glutamine intravenously based on ideal body weight, provided as 0.50 g/kg/day of the dipeptide alanyl-glutamine and 30 g/day enterally, provided as alanyl-glutamine and glycine-glutamine dipeptides.
1235648|NCT00133978|O4|Outcome|Placebo|Non-isonitrogenic, iso-caloric placebo solution
1235649|NCT00133978|O3|Outcome|Glutamine + Antioxidants|Glutamine and antioxidant supplementation
1235650|NCT00133978|O2|Outcome|Antioxidants|Antioxidant supplementation
1235651|NCT00133978|O1|Outcome|Glutamine|Glutamine supplementation
1235652|NCT00133978|O4|Outcome|No Antioxidants|Non-isonitrogenic, iso-caloric placebo solution
1235653|NCT00133978|O3|Outcome|Antioxidants|500 ug of selenium intravenously and the following vitamins and minerals enterally-- selenium 300 ug, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg.
1235654|NCT00133978|O2|Outcome|No Glutamine|Non-isonitrogenic, iso-caloric placebo solution
1235655|NCT00133978|O1|Outcome|Glutamine|0.35 g/kg/day of glutamine intravenously based on ideal body weight, provided as 0.50 g/kg/day of the dipeptide alanyl-glutamine and 30 g/day enterally, provided as alanyl-glutamine and glycine-glutamine dipeptides.
1235656|NCT00133978|O4|Outcome|Placebo|Non-isonitrogenic, iso-caloric placebo solution
1235657|NCT00133978|O3|Outcome|Glutamine + Antioxidants|Glutamine and antioxidant supplementation
1235664|NCT00133978|E4|Reported Event|Placebo|Non-isonitrogenic, iso-caloric placebo solution
1235665|NCT00133978|E3|Reported Event|Glutamine + Antioxidants|"Glutamine and antioxidant supplementation 0.35 g/kg/day of glutamine intravenously based on ideal body weight, provided as 0.50 g/kg/day of the dipeptide alanyl-glutamine and 30 g/day enterally, provided as alanyl-glutamine and glycine-glutamine dipeptides.~500 ug of selenium intravenously and the following vitamins and minerals enterally-- selenium 300 ug, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg."
1235666|NCT00133978|E2|Reported Event|Antioxidants|Antioxidant supplementation 500 ug of selenium intravenously and the following vitamins and minerals enterally-- selenium 300 ug, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg.
1235667|NCT00133978|E1|Reported Event|Glutamine|Glutamine supplementation 0.35 g/kg/day of glutamine intravenously based on ideal body weight, provided as 0.50 g/kg/day of the dipeptide alanyl-glutamine and 30 g/day enterally, provided as alanyl-glutamine and glycine-glutamine dipeptides.
1235668|NCT00133952|B3|Baseline|Total|Total of all reporting groups
1235669|NCT00133952|B2|Baseline|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
1235670|NCT00133952|B1|Baseline|Placebo|Taken orally daily for up to 48 months
1235671|NCT00133952|P2|Participant Flow|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
1235672|NCT00133952|P1|Participant Flow|Placebo|Taken orally daily for up to 48 months
1235673|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
1235674|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
1235675|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
1235676|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
1235677|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
1235678|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
1247980|NCT00098059|O4|Outcome|13 to <=18 Years|
1235687|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
1235688|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
1235689|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
1235690|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
1235691|NCT00133952|E2|Reported Event|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
1235692|NCT00133952|E1|Reported Event|Placebo|Taken orally daily for up to 48 months
1235693|NCT00133809|B1|Baseline|Islet Transplant|"10 subjects were found eligible and were can be matched to an appropriate donor will receive/have received an islet transplant---1 INELIGIBLE WHILE ON WAITLIST.~Transplantation of Human Islets: Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure"
1235694|NCT00133809|P1|Participant Flow|Islet Transplant|"All subjects who are found eligible and who can be matched to an appropriate donor will receive/have received an islet transplant~Transplantation of Human Islets: Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure"
1235695|NCT00133809|O1|Outcome|Islet Transplant|"All subjects who are found eligible and who can be matched to an appropriate donor will receive/have received an islet transplant~Transplantation of Human Islets: Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure"
1235696|NCT00133809|O1|Outcome|Islet Transplant|"All subjects who are found eligible and who can be matched to an appropriate donor will receive/have received an islet transplant~Transplantation of Human Islets: Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure"
1235697|NCT00133809|O1|Outcome|Islet Transplant|"All subjects who are found eligible and who can be matched to an appropriate donor will receive/have received an islet transplant~Transplantation of Human Islets: Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure"
1235698|NCT00133809|O1|Outcome|Islet Transplant|"All subjects who are found eligible and who can be matched to an appropriate donor will receive/have received an islet transplant~Transplantation of Human Islets: Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure"
1235699|NCT00133809|E1|Reported Event|Islet Transplant|"All subjects who are found eligible and who can be matched to an appropriate donor will receive/have received an islet transplant~Transplantation of Human Islets: Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure"
1235700|NCT00133705|B3|Baseline|Total|Total of all reporting groups
1235701|NCT00133705|B2|Baseline|Placebo|Twenty women received a placebo pill daily.
1235702|NCT00133705|B1|Baseline|Mifepristone 5 mg.|Twenty-two women received 5 mg. mifepristone daily.
1235703|NCT00133705|P2|Participant Flow|Placebo Group|These women received placebo capsules identical in appearance and weight to the 5 mg. mifepristone capsule to be taken once daily.
1235704|NCT00133705|P1|Participant Flow|Treatment Group|This group will receive 5 mg. capsules to be taken once daily.
1235705|NCT00133705|O2|Outcome|Placebo Group|These women received placebo capsules identical in appearance and weight to the 5 mg. mifepristone capsule to be taken once daily.
1235706|NCT00133705|O1|Outcome|Treatment Group|This group will receive 5 mg. capsules to be taken once daily.
1235707|NCT00133705|E2|Reported Event|Placebo Group|These women received placebo capsules identical in appearance and weight to the 5 mg. mifepristone capsule to be taken once daily.
1235708|NCT00133705|E1|Reported Event|Treatment Group|This group will receive 5 mg. capsules to be taken once daily.
1235709|NCT00133575|B8|Baseline|Total|Total of all reporting groups
1235710|NCT00133575|B7|Baseline|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
1235711|NCT00133575|B6|Baseline|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1235712|NCT00133575|B5|Baseline|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235835|NCT00132808|B3|Baseline|Placebo|Placebo given at randomization and Month 12
1235713|NCT00133575|B4|Baseline|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235714|NCT00133575|B3|Baseline|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235715|NCT00133575|B2|Baseline|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1235716|NCT00133575|B1|Baseline|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235717|NCT00133575|P7|Participant Flow|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
1235718|NCT00133575|P6|Participant Flow|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1235719|NCT00133575|P5|Participant Flow|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235720|NCT00133575|P4|Participant Flow|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235721|NCT00133575|P3|Participant Flow|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235722|NCT00133575|P2|Participant Flow|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1235723|NCT00133575|P1|Participant Flow|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235724|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
1235725|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1235726|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235727|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235728|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235729|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1235730|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235731|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
1235732|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1235733|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235734|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235735|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235736|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1235737|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235738|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
1235739|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1235740|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235741|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235742|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235743|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1235744|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235745|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
1235746|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1235747|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235748|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235749|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235750|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1235751|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235752|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
1235753|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1235754|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235755|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235756|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235757|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1235758|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235759|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
1235760|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1235761|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235762|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235763|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235764|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1247981|NCT00098059|O3|Outcome|6 to <13 Years|
1235765|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235766|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
1235767|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1235768|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235769|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235770|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235771|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1235772|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235773|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
1235774|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1235775|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235776|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235777|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235778|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1235779|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235780|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
1235781|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1235782|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235783|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235784|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235785|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1235786|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235787|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
1235788|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1235789|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235790|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235791|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235792|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1235793|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235794|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
1235795|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1235796|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235797|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235798|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235799|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1235800|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235801|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
1235802|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1235803|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235969|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
1235804|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235805|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235806|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1235807|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235808|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
1235809|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1235810|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235811|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235812|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235813|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1235814|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235815|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
1235816|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1235817|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235818|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235819|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235820|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1235821|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235822|NCT00133575|E7|Reported Event|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
1235823|NCT00133575|E6|Reported Event|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1235824|NCT00133575|E5|Reported Event|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235825|NCT00133575|E4|Reported Event|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235826|NCT00133575|E3|Reported Event|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
1235827|NCT00133575|E2|Reported Event|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
1235828|NCT00133575|E1|Reported Event|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
1235829|NCT00132873|B1|Baseline|Xyrem (Sodium Oxybate)|
1235836|NCT00132808|B2|Baseline|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
1235837|NCT00132808|B1|Baseline|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
1235838|NCT00132808|P3|Participant Flow|Placebo|Placebo given at randomization and Month 12
1235839|NCT00132808|P2|Participant Flow|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
1235840|NCT00132808|P1|Participant Flow|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
1235841|NCT00132808|O3|Outcome|Placebo|Placebo given at randomization and Month 12
1235842|NCT00132808|O2|Outcome|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
1235843|NCT00132808|O1|Outcome|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
1235844|NCT00132808|O3|Outcome|Placebo|Placebo given at randomization and Month 12
1235845|NCT00132808|O2|Outcome|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
1235846|NCT00132808|O1|Outcome|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
1235847|NCT00132808|O3|Outcome|Placebo|Placebo given at randomization and Month 12
1235848|NCT00132808|O2|Outcome|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
1235849|NCT00132808|O1|Outcome|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
1235850|NCT00132808|O3|Outcome|Placebo|Placebo given at randomization and Month 12
1235851|NCT00132808|O2|Outcome|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
1235852|NCT00132808|O1|Outcome|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
1235853|NCT00132808|O3|Outcome|Placebo|Placebo given at randomization and Month 12
1235854|NCT00132808|O2|Outcome|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
1235855|NCT00132808|O1|Outcome|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
1235856|NCT00132808|O3|Outcome|Placebo|Placebo given at randomization and Month 12
1235857|NCT00132808|O2|Outcome|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
1235858|NCT00132808|O1|Outcome|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
1235859|NCT00132808|E3|Reported Event|Placebo|Placebo given at randomization and Month 12
1235860|NCT00132808|E2|Reported Event|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
1235861|NCT00132808|E1|Reported Event|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
1235862|NCT00132769|B3|Baseline|Total|Total of all reporting groups
1235863|NCT00132769|B2|Baseline|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
1235864|NCT00132769|B1|Baseline|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
1235865|NCT00132769|P2|Participant Flow|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
1235866|NCT00132769|P1|Participant Flow|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
1235867|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
1235868|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
1235869|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
1235870|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
1235871|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
1235872|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
1235873|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
1235874|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
1235875|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
1235876|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
1235877|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
1235878|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
1235879|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
1235880|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
1235881|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
1235882|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
1235883|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
1235884|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
1235885|NCT00132769|E2|Reported Event|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
1235886|NCT00132769|E1|Reported Event|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
1235887|NCT00132730|B5|Baseline|Total|Total of all reporting groups
1235888|NCT00132730|B4|Baseline|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
1235889|NCT00132730|B3|Baseline|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
1235890|NCT00132730|B2|Baseline|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
1235891|NCT00132730|B1|Baseline|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
1235892|NCT00132730|P6|Participant Flow|Usual Care|Participants receive usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks in Periods IV and V (EXT2)
1235893|NCT00132730|P5|Participant Flow|MK-0873 2.5 mg + Usual Care|Participants receive MK-0873 2.5 mg tablets once daily plus usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks in Periods IV and V (EXT2)
1235894|NCT00132730|P4|Participant Flow|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
1235895|NCT00132730|P3|Participant Flow|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
1235896|NCT00132730|P2|Participant Flow|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), and MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base)
1235897|NCT00132730|P1|Participant Flow|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), and MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base)
1235898|NCT00132730|O4|Outcome|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
1235899|NCT00132730|O3|Outcome|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
1235900|NCT00132730|O2|Outcome|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
1235901|NCT00132730|O1|Outcome|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
1235902|NCT00132730|O4|Outcome|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
1235903|NCT00132730|O3|Outcome|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
1235904|NCT00132730|O2|Outcome|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
1235905|NCT00132730|O1|Outcome|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
1235906|NCT00132730|O4|Outcome|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
1235907|NCT00132730|O3|Outcome|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
1235908|NCT00132730|O2|Outcome|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
1235909|NCT00132730|O1|Outcome|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
1235910|NCT00132730|O4|Outcome|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
1235911|NCT00132730|O3|Outcome|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
1235912|NCT00132730|O2|Outcome|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
1235913|NCT00132730|O1|Outcome|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
1235914|NCT00132730|O4|Outcome|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
1235915|NCT00132730|O3|Outcome|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
1235916|NCT00132730|O2|Outcome|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
1235917|NCT00132730|O1|Outcome|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
1246138|NCT00104650|E1|Reported Event|Bisphosphonate IV Q4W|
1235918|NCT00132730|O4|Outcome|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
1235919|NCT00132730|O3|Outcome|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
1235920|NCT00132730|O2|Outcome|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
1235921|NCT00132730|O1|Outcome|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
1235922|NCT00132730|O4|Outcome|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
1235923|NCT00132730|O3|Outcome|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
1235924|NCT00132730|O2|Outcome|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
1235970|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
1235971|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy
1235925|NCT00132730|O1|Outcome|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
1235926|NCT00132730|O4|Outcome|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
1235927|NCT00132730|O3|Outcome|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
1235928|NCT00132730|O2|Outcome|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
1235929|NCT00132730|O1|Outcome|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
1235930|NCT00132730|E8|Reported Event|Usual Care EXT2|Participants receive usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks in Periods IV and V (EXT2)
1235931|NCT00132730|E7|Reported Event|MK-0873 2.5 mg + Usual Care EXT 2|Participants receive MK-0873 2.5 mg tablets once daily plus usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks in Periods IV and V (EXT2)
1235932|NCT00132730|E6|Reported Event|Placebo EXT 1|Participants receive placebo tablets once daily for 12 weeks in Period III (EXT1)
1235933|NCT00132730|E5|Reported Event|MK-0873 2.5 mg EXT 1|Participants receive MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
1235934|NCT00132730|E4|Reported Event|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
1235935|NCT00132730|E3|Reported Event|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
1235936|NCT00132730|E2|Reported Event|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), and MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base)
1235937|NCT00132730|E1|Reported Event|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), and MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base)
1235938|NCT00132691|B3|Baseline|Total|Total of all reporting groups
1235939|NCT00132691|B2|Baseline|Standard Systemic Treatment|Systemic corticosteroid therapy with immunosuppression as indicated
1235940|NCT00132691|B1|Baseline|Flucinolone Acetonide Intraocular Implant|Local therapy with fluocinolone acetonide 0.59 mg implant (Retisert; Bausch & Lomb Inc.) in each eye with uveitis of sufficient severity to justify treatment with systemic corticosteroids
1235941|NCT00132691|P2|Participant Flow|Standard Systemic Treatment|Systemic corticosteroid therapy with immunosuppression as indicated
1235942|NCT00132691|P1|Participant Flow|Flucinolone Acetonide Intraocular Implant|Local therapy with fluocinolone acetonide 0.59 mg implant (Retisert; Bausch & Lomb Inc.) in each eye with uveitis of sufficient severity to justify treatment with systemic corticosteroids
1235943|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
1235944|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
1235945|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
1235946|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
1235947|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
1235948|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
1235949|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
1235950|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
1235951|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
1235952|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
1235953|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
1235954|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
1235955|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy
1235956|NCT00132691|O1|Outcome|Fluocinolone Acetonide Implant|Participants randomized to receive implant therapy
1235957|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy
1235958|NCT00132691|O1|Outcome|Fluocinolone Acetonide Implant|Participants randomized to receive implant therapy
1235959|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
1235960|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
1235961|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy
1235962|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy
1235963|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy
1235964|NCT00132691|O1|Outcome|Fluocinolone Acetonide Implant|Participants randomized to receive implant therapy
1235965|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy
1235966|NCT00132691|O1|Outcome|Fluocinolone Acetonide Implant|Participants randomized to receive implant therapy
1235967|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
1235968|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
1247982|NCT00098059|O2|Outcome|2 to <6 Years|
1235972|NCT00132691|O1|Outcome|Fluocinolone Acetonide Implant|Participants randomized to receive implant therapy
1235973|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
1235974|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
1235975|NCT00132691|O2|Outcome|Systemic Therapy|Oral corticosteroids supplemented with immunosuppressive drugs if indicated were given according to published guidelines developed by an expert panel. For participants with active uveitis at baseline, 1 mg/kg/day up to 60 mg/day of prednisone was given until uveitis was controlled or 4 weeks had elapsed. When control was achieved, prednisone was tapered per study guidelines. Immunosuppressive drugs were added when uveitis was not initially controlled with prednisone alone, as corticosteroid-sparing agents when prednisone could not be tapered to 10 mg/day without reactivation of uveitis and for specific uveitis syndromes. Choice of immunosuppressant was made by the study ophthalmologist; immunosuppressant administration and monitoring for toxicity was conducted according to expert guidelines.
1235976|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|A fluocinolone acetonide intravitreal implant (0.59 mg) was surgically placed by a study-certified surgeon was placed in each eligible eye. The first eye was implanted within 28 days of randomization and, if eligible, the second eye within the next 28 days. Prior to implant surgery, topical, periocular or systemic corticosteroids where used as needed to quiet the anterior chamber. Post-implant, systemic corticosteroids and immunosuppressive drugs were tapered and discontinued. If the second eye was not eligible for an implant initially but later became eligible, an implant was placed in the second eye at that time. The treatment algorithm included re-implantation upon reactivation and treatment per best medical judgment for failure to achieve inflammation control, treatment-limiting toxicity and systemic disease requiring systemic therapy.
1235977|NCT00132691|E2|Reported Event|Systemic Therapy|Participants randomized to receive systemic therapy.
1235978|NCT00132691|E1|Reported Event|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
1235979|NCT00132678|B3|Baseline|Total|Total of all reporting groups
1235980|NCT00132678|B2|Baseline|Placebo|IM injection every 2 weeks
1235981|NCT00132678|B1|Baseline|RISPERDAL CONSTA|risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg IM injection every 2 weeks
1235982|NCT00132678|P3|Participant Flow|Open-Label Oral Risperidone|(flexible dosage) 1 to 6 mg/day for the first 3 weeks
1235983|NCT00132678|P2|Participant Flow|Placebo|intramuscular (IM) injection every 2 weeks
1235984|NCT00132678|P1|Participant Flow|RISPERDAL CONSTA|risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg intramuscular (IM) injection every 2 weeks
1235985|NCT00132678|O2|Outcome|Placebo|IM injection every 2 weeks
1235986|NCT00132678|O1|Outcome|RISPERDAL CONSTA|risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg IM injection every 2 weeks
1235987|NCT00132678|O2|Outcome|Placebo|IM injection every 2 weeks
1235988|NCT00132678|O1|Outcome|RISPERDAL CONSTA|risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg IM injection every 2 weeks
1235989|NCT00132678|O2|Outcome|Placebo|IM injection every 2 weeks
1235990|NCT00132678|O1|Outcome|RISPERDAL CONSTA|risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg IM injection every 2 weeks
1235991|NCT00132678|E4|Reported Event|Open Label RISPERDAL CONSTA|Open-label Period III. Risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg intramuscular (IM) injection every 2 weeks.
1235992|NCT00132678|E3|Reported Event|Open-Label Oral Risperidone|Open-label Period II. Flexible dosage. 1 to 6 mg/day for the first 3 weeks
1235993|NCT00132678|E2|Reported Event|Placebo|Double-blind Period IV. Intramuscular (IM) injection every 2 weeks
1235994|NCT00132678|E1|Reported Event|RISPERDAL CONSTA|Double-blind Period IV. Risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg intramuscular (IM) injection every 2 weeks.
1235995|NCT00132496|B3|Baseline|Total|Total of all reporting groups
1235996|NCT00132496|B2|Baseline|Rabeprazole 20 mg|once daily for 8 weeks
1235997|NCT00132496|B1|Baseline|Rabeprazole 10 mg|once daily for 8 weeks
1235998|NCT00132496|P2|Participant Flow|Rabeprazole 20 mg|once daily for 8 weeks
1235999|NCT00132496|P1|Participant Flow|Rabeprazole 10 mg|once daily for 8 weeks
1236000|NCT00132496|O2|Outcome|Rabeprazole 20 mg|once daily for 8 weeks
1236001|NCT00132496|O1|Outcome|Rabeprazole 10 mg|once daily for 8 weeks
1236002|NCT00132496|E2|Reported Event|Rabeprazole 20 mg|once daily for 8 weeks
1246146|NCT00104637|O2|Outcome|Placebo|Participants that received Placebo
1236003|NCT00132496|E1|Reported Event|Rabeprazole 10 mg|once daily for 8 weeks
1236004|NCT00132314|B3|Baseline|Total|Total of all reporting groups
1236005|NCT00132314|B2|Baseline|Oral Antipsychotic|oral antipsychotic medication
1236006|NCT00132314|B1|Baseline|Injectable Risperidone|long-acting injectable risperidone
1236007|NCT00132314|P2|Participant Flow|Oral Antipsychotic|oral antipsychotic medication
1236008|NCT00132314|P1|Participant Flow|Injectable Risperidone|long-acting injectable risperidone
1236009|NCT00132314|O2|Outcome|Oral Antipsychotic|oral antipsychotic medication
1236010|NCT00132314|O1|Outcome|Injectable Risperidone|long-acting injectable risperidone
1236011|NCT00132314|O2|Outcome|Oral Antipsychotic|oral antipsychotic medication
1236012|NCT00132314|O1|Outcome|Injectable Risperidone|long-acting injectable risperidone
1236013|NCT00132314|E2|Reported Event|Oral Antipsychotic|oral antipsychotic medication
1236014|NCT00132314|E1|Reported Event|Injectable Risperidone|long-acting injectable risperidone
1236015|NCT00132132|B3|Baseline|Total|Total of all reporting groups
1236016|NCT00132132|B2|Baseline|Standard of Care/Control|Standard of Care/control group received visits to the primary care provider and a referral to a nutritionist
1236017|NCT00132132|B1|Baseline|Behavioral Program|This is a long term randomized controlled study looking at the effect of a Behavioral program on BMI in a population 10-20years old with a BMI greater than or equal to 85%. The intervention group attends a monthly 4 hour session which incorporates exercise, education, empowerment and incentives. Both groups are referred to a dietician. The primary outcome is change in BMI and the secondary outcome is improvement in fasting metabolic parameters (lipid panel, insulin, glucose).
1236018|NCT00132132|P2|Participant Flow|Standard of Care/Control|Standard of Care/control group received visits to the primary care provider and a referral to a nutritionist
1236019|NCT00132132|P1|Participant Flow|Behavioral Program|This is a long term randomized controlled study looking at the effect of a Behavioral program on BMI in a population 10-20years old with a BMI greater than or equal to 85%. The intervention group attends a monthly 4 hour session which incorporates exercise, education, empowerment and incentives. Both groups are referred to a dietician. The primary outcome is change in BMI and the secondary outcome is improvement in fasting metabolic parameters (lipid panel, insulin, glucose).
1236020|NCT00132132|O2|Outcome|Standard of Care/Control Group|The Standard of Care/Control group received visits to primary care provider and referral to nutritionist
1236021|NCT00132132|O1|Outcome|Intervention Group|The intervention group attended monthly, 4 hour sessions for one year
1236022|NCT00132132|O2|Outcome|Standard of Care/Control Group|The Standard of Care/Control group received visits to primary care provider and referral to nutritionist
1236023|NCT00132132|O1|Outcome|Intervention Group|The intervention group attended monthly, 4 hour sessions for one year
1236024|NCT00132132|E2|Reported Event|Standard of Care/Control|Standard of Care/control group received visits to the primary care provider and a referral to a nutritionist
1236025|NCT00132132|E1|Reported Event|Behavioral Program|This is a long term randomized controlled study looking at the effect of a Behavioral program on BMI in a population 10-20years old with a BMI greater than or equal to 85%. The intervention group attends a monthly 4 hour session which incorporates exercise, education, empowerment and incentives. Both groups are referred to a dietician. The primary outcome is change in BMI and the secondary outcome is improvement in fasting metabolic parameters (lipid panel, insulin, glucose).
1236026|NCT00132028|B1|Baseline|SAHA (Vorinostat)|Patients receive vorinostat 400 mg/day on days 1-14 of every 21-day cycle. Patients continue treatment until progression.
1236027|NCT00132028|P1|Participant Flow|SAHA (Vorinostat)|Patients receive vorinostat 400 mg/day on days 1-14 of every 21-day cycle. Patients continue treatment until progression.
1236028|NCT00132028|O1|Outcome|SAHA (Vorinostat)|Patients receive vorinostat 400 mg/day on days 1-14 of every 21-day cycle. Patients continue treatment until progression.
1236029|NCT00132028|O1|Outcome|SAHA (Vorinostat)|Patients receive vorinostat 400 mg/day on days 1-14 of every 21-day cycle. Patients continue treatment until progression.
1236030|NCT00132028|O1|Outcome|SAHA (Vorinostat)|Patients receive vorinostat 400 mg/day on days 1-14 of every 21-day cycle. Patients continue treatment until progression.
1236031|NCT00132028|E1|Reported Event|SAHA (Vorinostat)|
1236032|NCT00132002|B1|Baseline|Arm 1|Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
1236033|NCT00132002|P1|Participant Flow|Arm 1|Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
1236034|NCT00132002|O1|Outcome|Arm 1|Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
1236035|NCT00132002|O1|Outcome|Arm 1|Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
1236036|NCT00132002|O1|Outcome|Arm 1|Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
1236037|NCT00132002|E1|Reported Event|Arm 1|Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
1236038|NCT00131937|B1|Baseline|Treatment (Sorafenib)|"Patients receive oral sorafenib 400 mg PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally"
1236039|NCT00131937|P1|Participant Flow|Treatment (Sorafenib)|"Patients receive oral sorafenib 400 mg PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally"
1236040|NCT00131937|O1|Outcome|Treatment (Sorafenib)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally"
1236041|NCT00131937|O1|Outcome|Treatment (Sorafenib)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally"
1236042|NCT00131937|O1|Outcome|Treatment (Sorafenib)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally"
1236043|NCT00131937|E1|Reported Event|Treatment (Sorafenib)|All patients who received Sorafenib treatment.
1236044|NCT00131911|B3|Baseline|Total|Total of all reporting groups
1236045|NCT00131911|B2|Baseline|Group B (Islet Cell and Other Neuroendocrine Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
1236046|NCT00131911|B1|Baseline|Group A (Patients With Carcinoid Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
1236047|NCT00131911|P2|Participant Flow|Group B (Islet Cell and Other Neuroendocrine Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
1236048|NCT00131911|P1|Participant Flow|Group A (Patients With Carcinoid Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
1236049|NCT00131911|O2|Outcome|Group B (Islet Cell and Other Neuroendocrine Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
1236050|NCT00131911|O1|Outcome|Group A (Patients With Carcinoid Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
1236051|NCT00131911|O2|Outcome|Group B (Islet Cell and Other Neuroendocrine Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
1236052|NCT00131911|O1|Outcome|Group A (Patients With Carcinoid Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
1236053|NCT00131911|O2|Outcome|Group B (Islet Cell and Other Neuroendocrine Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
1236054|NCT00131911|O1|Outcome|Group A (Patients With Carcinoid Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
1236055|NCT00131911|O2|Outcome|Group B (Islet Cell and Other Neuroendocrine Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
1236056|NCT00131911|O1|Outcome|Group A (Patients With Carcinoid Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
1236057|NCT00131911|O2|Outcome|Group B (Islet Cell and Other Neuroendocrine Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
1236058|NCT00131911|O1|Outcome|Group A (Patients With Carcinoid Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
1236059|NCT00131911|E1|Reported Event|All Patients|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
1236060|NCT00131885|B5|Baseline|Total|Total of all reporting groups
1236061|NCT00131885|B4|Baseline|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
1236062|NCT00131885|B3|Baseline|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
1236063|NCT00131885|B2|Baseline|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
1236064|NCT00131885|B1|Baseline|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
1236065|NCT00131885|P4|Participant Flow|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
1236066|NCT00131885|P3|Participant Flow|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
1236067|NCT00131885|P2|Participant Flow|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
1236068|NCT00131885|P1|Participant Flow|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
1236069|NCT00131885|O4|Outcome|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
1236070|NCT00131885|O3|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
1236071|NCT00131885|O2|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
1236072|NCT00131885|O1|Outcome|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
1236145|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
1236073|NCT00131885|O4|Outcome|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
1236074|NCT00131885|O3|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
1236075|NCT00131885|O2|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
1236076|NCT00131885|O1|Outcome|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
1236077|NCT00131885|O4|Outcome|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
1236078|NCT00131885|O3|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
1236079|NCT00131885|O2|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
1247983|NCT00098059|O1|Outcome|1 to < 2 Years|
1236080|NCT00131885|O1|Outcome|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
1236081|NCT00131885|O4|Outcome|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
1236082|NCT00131885|O3|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
1236083|NCT00131885|O2|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
1236084|NCT00131885|O1|Outcome|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
1236085|NCT00131885|O4|Outcome|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
1236086|NCT00131885|O3|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
1236087|NCT00131885|O2|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
1236088|NCT00131885|O1|Outcome|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
1236089|NCT00131885|O4|Outcome|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
1236090|NCT00131885|O3|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
1236091|NCT00131885|O2|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
1236092|NCT00131885|O1|Outcome|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
1236093|NCT00131885|E4|Reported Event|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
1236094|NCT00131885|E3|Reported Event|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
1236146|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
1238197|NCT00126776|B1|Baseline|Disease Management for COPD|disease management for COPD
1236095|NCT00131885|E2|Reported Event|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
1236096|NCT00131885|E1|Reported Event|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
1236097|NCT00131677|B3|Baseline|Total|Total of all reporting groups
1236098|NCT00131677|B2|Baseline|Placebo|Placebo arm--received matching placebo
1236099|NCT00131677|B1|Baseline|Tenofovir Disoproxil Fumarate|Active arm: assigned to take TDF, 300mg po daily.
1236100|NCT00131677|P2|Participant Flow|Placebo|Participants received matching placebo, to be taken daily.
1236101|NCT00131677|P1|Participant Flow|Tenofovir Disoproxil Fumarate|Participants received TDF 300mg orally daily for 24 months (immediate arm) or 15 months (delayed arm).
1236102|NCT00131677|O2|Outcome|Placebo|Placebo arm--received matching placebo
1236103|NCT00131677|O1|Outcome|Tenofovir Disoproxil Fumarate|Active arm: assigned to take TDF, 300mg po daily.
1236104|NCT00131677|O2|Outcome|Placebo|Placebo arm--received matching placebo
1236105|NCT00131677|O1|Outcome|Tenofovir Disoproxil Fumarate|Active arm: assigned to take TDF, 300mg po daily.
1236106|NCT00131677|O1|Outcome|All Enrolled Participants|
1236107|NCT00131677|O1|Outcome|Treatment Emergent Cohort|Includes all who entered treatment emergent cohort (active and placebo arms)
1236108|NCT00131677|O2|Outcome|Placebo|Matching placebo daily
1236109|NCT00131677|O1|Outcome|Tenofovir Disoproxil Fumarate|TDF, 300 mg orally daily.
1236110|NCT00131677|O2|Outcome|Placebo|Matching placebo daily
1236111|NCT00131677|O1|Outcome|Tenofovir Disoproxil Fumarate|TDF, 300 mg orally daily
1236112|NCT00131677|E2|Reported Event|Placebo|Matching placebo daily
1236113|NCT00131677|E1|Reported Event|Tenofovir Disoproxil Fumarate|Active arm: assigned to take TDF, 300mg po daily.
1236114|NCT00131664|B4|Baseline|Total|Total of all reporting groups
1236115|NCT00131664|B3|Baseline|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
1236116|NCT00131664|B2|Baseline|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
1236117|NCT00131664|B1|Baseline|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
1236118|NCT00131664|P6|Participant Flow|Metformin and Amaryl|Metformin Arm: At month 6, if patients not achieving A1C target of less than 7 received additional specified drug therapy. Amaryl™ was added and titrated up to 4 mg once daily maximum dose for an additional 6 months.
1236119|NCT00131664|P5|Participant Flow|Avandamet and Amaryl|Avandamet™ Arm: At month 6, if patients not achieving A1C target of less than 7 received additional specified drug therapy. Amaryl™ was added and titrated up to 4 mg once daily maximum dose for an additional 6 months
1236120|NCT00131664|P4|Participant Flow|Avandia, Amaryl and Metformin|Avandia™ + Amaryl™ Arm: At month 6, if patients not achieving A1C target of less than 7 received additional specified drug therapy. Metformin was added and titrated up to 1000 mg twice daily (BID) maximum dose for an additional 6 months.
1236121|NCT00131664|P3|Participant Flow|Metformin|Metformin Arm: initial dose of 500 mg twice daily (BID) was titrated up to 850 mg BID at month 2. At month 4, it was further titrated up to 1000 mg BID.
1236122|NCT00131664|P2|Participant Flow|Avandamet|Avandamet™ Arm: at month 2 the initial dose of 2 mg / 500 mg twice daily (BID) was titrated up to 4 mg / 500 mg BID; at month 4 it was be further titrated up to 4 mg / 1000 mg BID.
1236123|NCT00131664|P1|Participant Flow|Avandia and Amaryl|Avandia™ + Amaryl™ Arm: at month 2 initial dose of 4 mg + 1 mg once daily (OD) was titrated up to 8 mg + 1 mg OD; at month 4 it was further titrated up to 8 mg + 2 mg OD.
1236124|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
1236125|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
1236126|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
1236127|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
1236128|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
1236129|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
1236130|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
1236131|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
1236132|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
1236133|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
1236134|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
1236135|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
1236136|NCT00131664|O3|Outcome|Metformin|: 500 mg twice daily titration up to 1000 mg twice daily over 6 months
1236137|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
1236138|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
1236139|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
1236140|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
1236141|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
1236142|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
1236143|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
1236144|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
1236147|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
1236148|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
1236149|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
1236150|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
1236151|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
1236152|NCT00131664|O2|Outcome|Avandamet|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
1236153|NCT00131664|O1|Outcome|Avandia and Amaryl|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
1236154|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
1236155|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
1236156|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
1236157|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
1236158|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
1236159|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
1236160|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
1236161|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
1236162|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
1236163|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
1236164|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
1236165|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
1236166|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
1236167|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
1236168|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
1236169|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
1236170|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
1236171|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
1236172|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
1236173|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
1236174|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
1236175|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
1236176|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
1236177|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
1236178|NCT00131664|E3|Reported Event|Metformin|Metformin Arm: initial dose of 500 mg BID was titrated up to 850 mg BID at month 2. At month 4, it was further titrated up to 1000 mg BID. At month 6 (visit 6), patients not achieving target received additional specified drug therapy: Amaryl™ was added and titrated up to 4 mg OD maximum dose for an additional 6 months.
1236179|NCT00131664|E2|Reported Event|Avandamet|Avandamet™ Arm: at month 2 the initial dose of 2 mg / 500 mg BID was titrated up to 4 mg / 500 mg BID; at month 4 it was be further titrated up to 4 mg / 1000 mg BID. At month 6, patients not achieving target received additional specified drug therapy Amaryl™ was added and titrated up to 4 mg OD maximum dose for an additional 6 months
1236180|NCT00131664|E1|Reported Event|Avandia and Amaryl|Avandia™ + Amaryl™ Arm: at month 2 initial dose of 4 mg +1 mg OD was titrated up to 8 mg + 1 mg OD; at month 4 it was further titrated up to 8 mg / 2 mg OD. At month 6, patients not achieving target received additional specified drug therapy: Metformin was added and titrated up to 1000 mg BID maximum dose for an additional 6 months.
1236181|NCT00131573|B3|Baseline|Total|Total of all reporting groups
1236182|NCT00131573|B2|Baseline|Treatment|Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
1236183|NCT00131573|B1|Baseline|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
1236184|NCT00131573|P2|Participant Flow|Treatment|"Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit.~Stimulation On from 45 days post 12 month visit and on."
1236185|NCT00131573|P1|Participant Flow|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
1236186|NCT00131573|O2|Outcome|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
1236187|NCT00131573|O1|Outcome|Treatment|Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
1236188|NCT00131573|O2|Outcome|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
1236189|NCT00131573|O1|Outcome|Treatment|"Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit.~Stimulation On from 45 days post 12 month visit and on."
1236190|NCT00131573|E2|Reported Event|Treatment|Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
1238198|NCT00126776|P2|Participant Flow|Usual Care|usual care
1236191|NCT00131573|E1|Reported Event|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
1236192|NCT00131508|B3|Baseline|Total|Total of all reporting groups
1236193|NCT00131508|B2|Baseline|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
1236194|NCT00131508|B1|Baseline|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
1236195|NCT00131508|P2|Participant Flow|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
1236196|NCT00131508|P1|Participant Flow|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
1236197|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
1236198|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
1236199|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
1236200|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
1236201|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
1236202|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
1236203|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
1236204|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
1236205|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
1236206|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
1236207|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
1236208|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
1236209|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
1236210|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
1236211|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
1236212|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
1236213|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
1236214|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
1236215|NCT00131508|E2|Reported Event|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
1236216|NCT00131508|E1|Reported Event|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
1236217|NCT00131456|B3|Baseline|Total|Total of all reporting groups
1236218|NCT00131456|B2|Baseline|Venlafaxine|Venlafaxine: VEN-XR was titrated to the target dose of 225 mg/day (or the maximum tolerated dose) over the three weeks after randomization. After the fourth week post-randomization, patients with persistent depression who were not rated as having a CGI-Depression score of 1 (“very much improved’) and who were tolerating 225 mg/day had their dose increased to a maximum of 375 mg/day.
1236219|NCT00131456|B1|Baseline|Placebo|Matched Placebo
1236220|NCT00131456|P2|Participant Flow|Venlafaxine|"Venlafaxine: VEN-XR was titrated to the target dose of 225 mg/day (or the maximum tolerated dose) over the three weeks after randomization. After the fourth week post-randomization, patients with persistent depression who were not rated as having a CGI-Depression score of 1 (very much improved') and who were tolerating 225 mg/day had their dose increased to a maximum of 375 mg/day."
1236221|NCT00131456|P1|Participant Flow|Placebo|Matched Placebo
1236222|NCT00131456|O2|Outcome|Venlafaxine|Venlafaxine: VEN-XR was titrated to the target dose of 225 mg/day (or the maximum tolerated dose) over the three weeks after randomization. After the fourth week post-randomization, patients with persistent depression who were not rated as having a CGI-Depression score of 1 (“very much improved’) and who were tolerating 225 mg/day had their dose increased to a maximum of 375 mg/day.
1236223|NCT00131456|O1|Outcome|Placebo|Matched Placebo
1236224|NCT00131456|E2|Reported Event|Venlafaxine|Venlafaxine: VEN-XR was titrated to the target dose of 225 mg/day (or the maximum tolerated dose) over the three weeks after randomization. After the fourth week post-randomization, patients with persistent depression who were not rated as having a CGI-Depression score of 1 (“very much improved’) and who were tolerating 225 mg/day had their dose increased to a maximum of 375 mg/day.
1236225|NCT00131456|E1|Reported Event|Placebo|Matched Placebo
1236226|NCT00131378|B5|Baseline|Total|Total of all reporting groups
1236227|NCT00131378|B4|Baseline|Male on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
1236228|NCT00131378|B3|Baseline|Male on GH|"Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
1236229|NCT00131378|B2|Baseline|Female on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
1236230|NCT00131378|B1|Baseline|Female on GH|"Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
1236231|NCT00131378|P4|Participant Flow|Male on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
1236232|NCT00131378|P3|Participant Flow|Male on GH|"Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
1236233|NCT00131378|P2|Participant Flow|Female on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
1236234|NCT00131378|P1|Participant Flow|Female on GH|"Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
1236235|NCT00131378|O2|Outcome|Male on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
1236236|NCT00131378|O1|Outcome|Male on GH|"Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
1236237|NCT00131378|O2|Outcome|Female on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
1236238|NCT00131378|O1|Outcome|Female on GH|"Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
1236239|NCT00131378|O4|Outcome|Female on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
1236240|NCT00131378|O3|Outcome|Female on GH|"Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
1236241|NCT00131378|O2|Outcome|Male on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
1236273|NCT00131352|O1|Outcome|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
1236242|NCT00131378|O1|Outcome|Male on GH|"Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
1236243|NCT00131378|O4|Outcome|Female on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
1236244|NCT00131378|O3|Outcome|Female on GH|"Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
1236245|NCT00131378|O2|Outcome|Male on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
1236246|NCT00131378|O1|Outcome|Male on GH|"Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
1236247|NCT00131378|O4|Outcome|Female on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
1236248|NCT00131378|O3|Outcome|Female on GH|"Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
1236249|NCT00131378|O2|Outcome|Male on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
1236250|NCT00131378|O1|Outcome|Male on GH|"Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
1236251|NCT00131378|E4|Reported Event|Male on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
1236252|NCT00131378|E3|Reported Event|Male on GH|"Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
1236253|NCT00131378|E2|Reported Event|Female on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
1236254|NCT00131378|E1|Reported Event|Female on GH|"Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
1236255|NCT00131352|B3|Baseline|Total|Total of all reporting groups
1236256|NCT00131352|B2|Baseline|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
1236257|NCT00131352|B1|Baseline|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
1236258|NCT00131352|P2|Participant Flow|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline during the Initial Treatment Period.
1236259|NCT00131352|P1|Participant Flow|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period. Participants from both treatment arms had the opportunity to receive an additional 6 mL hylan G-F 20 (Synvisc) during the Repeat Treatment Period.
1236260|NCT00131352|O2|Outcome|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
1236261|NCT00131352|O1|Outcome|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
1236262|NCT00131352|O2|Outcome|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
1236263|NCT00131352|O1|Outcome|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
1236264|NCT00131352|O2|Outcome|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
1236265|NCT00131352|O1|Outcome|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
1236266|NCT00131352|O2|Outcome|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
1236267|NCT00131352|O1|Outcome|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
1236268|NCT00131352|O2|Outcome|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
1236269|NCT00131352|O1|Outcome|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
1236270|NCT00131352|O2|Outcome|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
1236271|NCT00131352|O1|Outcome|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
1236272|NCT00131352|O2|Outcome|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
1236274|NCT00131352|O2|Outcome|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
1236275|NCT00131352|O1|Outcome|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
1236276|NCT00131352|E4|Reported Event|Synvisc (From Saline Control) - Repeat Treatment Period|Participants from the Saline Control Initial Treatment Period had the opportunity to receive 6 mL hylan G-F 20 (Synvisc) during the Repeat Treatment Period (weeks 26-30).
1236277|NCT00131352|E3|Reported Event|Synvisc - Repeat Treatment Period|Participants from the Synvisc Initial Treatment Period had the opportunity to receive 6 mL hylan G-F 20 (Synvisc) during the Repeat Treatment Period (weeks 26-30).
1236278|NCT00131352|E2|Reported Event|Saline Control - Initial Treatment Period|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline during the initial treatment period.
1236279|NCT00131352|E1|Reported Event|Synvisc - Initial Treatment Period|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period (up to week 26).
1236280|NCT00131248|B1|Baseline|All Study Participants|
1236281|NCT00131248|P2|Participant Flow|Placebo, Medications, Placebo (Group 2)|"received 3-day course placebo, followed by 7-day course anti-reflux medication, followed by 4-day course placebo.~All study medication administered via nipple or OG tube. Metaclopramide (anti-reflux) given in 0.1mg/kg/dose q6hrs, 30min. prior to feedings. Ranitidine, 3mg/kg/dose, q12hrs. Saline placebo at same respective volumes."
1236282|NCT00131248|P1|Participant Flow|Medications, Placebo, Medications (Group 1)|"3-day course of anti-reflux medications, followed by 7-day course placebo, followed by 4-day course anti-reflux medications.~All study medication administered via nipple or OG tube. Metaclopramide (anti-reflux) given in 0.1mg/kg/dose q6hrs, 30min. prior to feedings. Ranitidine, 3mg/kg/dose, q12hrs. Saline placebo at same respective volumes."
1236283|NCT00131248|O2|Outcome|Placebo|
1236284|NCT00131248|O1|Outcome|Medications|
1236285|NCT00131248|E2|Reported Event|Placebo|
1236286|NCT00131248|E1|Reported Event|Medications|
1236287|NCT00130923|B3|Baseline|Total|Total of all reporting groups
1236288|NCT00130923|B2|Baseline|Oral Risperidone Aka Risperal|Oral Risperidone aka Risperdal. Participants who were randomized to take oral risperidone were titrated over two weeks up to a target dose of 4 mg per day. The maximum daily dose of oral risperidone was 6 mg.
1236289|NCT00130923|B1|Baseline|Risperidone Long Acting Injectable (LAI)|Risperidone Long Acting Injectable (LAI), begun with 25 mg dose given intramuscularly(IM)every two weeks. The dose was titrated up to a target dose of 37.5 mg IM, with injections given every two weeks. The maximum dose of LAI risperidone was 50 mg every two weeks.
1236290|NCT00130923|P2|Participant Flow|Oral Risperidone Aka Risperal|Oral Risperidone aka Risperdal. Participants who were randomized to take oral risperidone were titrated over two weeks up to a target dose of 4 mg per day. The maximum daily dose of oral risperidone was 6 mg.
1236291|NCT00130923|P1|Participant Flow|Risperidone Long Acting Injectable (LAI)|Risperidone Long Acting Injectable (LAI), begun with 25 mg dose given intramuscularly(IM)every two weeks. The dose was titrated up to a target dose of 37.5 mg IM, with injections given every two weeks. The maximum dose of LAI risperidone was 50 mg every two weeks.
1236292|NCT00130923|O2|Outcome|Oral Risperidone Aka Risperal|Oral Risperidone aka Risperdal. Participants who were randomized to take oral risperidone were titrated over two weeks up to a target dose of 4 mg per day. The maximum daily dose of oral risperidone was 6 mg.
1236293|NCT00130923|O1|Outcome|Risperidone Long Acting Injectable (LAI)|Risperidone Long Acting Injectable (LAI), begun with 25 mg dose given intramuscularly(IM)every two weeks. The dose was titrated up to a target dose of 37.5 mg IM, with injections given every two weeks. The maximum dose of LAI risperidone was 50 mg every two weeks.
1236294|NCT00130923|E2|Reported Event|Oral Risperidone Aka Risperal|Oral Risperidone aka Risperdal. Participants who were randomized to take oral risperidone were titrated over two weeks up to a target dose of 4 mg per day. The maximum daily dose of oral risperidone was 6 mg.
1236416|NCT00130117|O2|Outcome|Oral Contraceptive Pills (OCPs)|"PLACEBO~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.~Placebo: placebo (no active medication)"
1250394|NCT00091793|P1|Participant Flow|Denosumab 60 mg Q6M|
1236295|NCT00130923|E1|Reported Event|Risperidone Long Acting Injectable (LAI)|Risperidone Long Acting Injectable (LAI), begun with 25 mg dose given intramuscularly(IM)every two weeks. The dose was titrated up to a target dose of 37.5 mg IM, with injections given every two weeks. The maximum dose of LAI risperidone was 50 mg every two weeks.
1236296|NCT00130832|B3|Baseline|Total|Total of all reporting groups
1236297|NCT00130832|B2|Baseline|RotaTeq and Oral Poliovirus (OPV) Staggered|Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
1236298|NCT00130832|B1|Baseline|RotaTeq and Oral Poliovirus (OPV) Concomitantly|Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart
1236299|NCT00130832|P2|Participant Flow|RotaTeq and Oral Poliovirus (OPV) Staggered|Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
1236300|NCT00130832|P1|Participant Flow|RotaTeq and Oral Poliovirus (OPV) Concomitantly|Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart
1236301|NCT00130832|O2|Outcome|RotaTeq and Oral Poliovirus (OPV) Staggered|Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
1236302|NCT00130832|O1|Outcome|RotaTeq and Oral Poliovirus (OPV) Concomitantly|Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart
1236303|NCT00130832|O2|Outcome|RotaTeq and Oral Poliovirus (OPV) Staggered|Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
1236304|NCT00130832|O1|Outcome|RotaTeq and Oral Poliovirus (OPV) Concomitantly|Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart
1236305|NCT00130832|O2|Outcome|RotaTeq and Oral Poliovirus (OPV) Staggered|Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
1236306|NCT00130832|O1|Outcome|RotaTeq and Oral Poliovirus (OPV) Concomitantly|Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart
1236723|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
1236307|NCT00130832|E2|Reported Event|RotaTeq and Oral Poliovirus (OPV) Staggered|Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
1236308|NCT00130832|E1|Reported Event|RotaTeq and Oral Poliovirus (OPV) Concomitantly|Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart
1236309|NCT00130793|B3|Baseline|Total|Total of all reporting groups
1236310|NCT00130793|B2|Baseline|ZOSTAVAX™ With PGS|ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
1236311|NCT00130793|B1|Baseline|ZOSTAVAX™ With PGSU|ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
1236312|NCT00130793|P2|Participant Flow|ZOSTAVAX™ With PGS|ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
1236313|NCT00130793|P1|Participant Flow|ZOSTAVAX™ With PGSU|ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
1236314|NCT00130793|O2|Outcome|ZOSTAVAX™ With PGS|ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
1236315|NCT00130793|O1|Outcome|ZOSTAVAX™With PGSU|ZOSTAVAX™with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
1236316|NCT00130793|O2|Outcome|ZOSTAVAX™ With PGS|ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
1236317|NCT00130793|O1|Outcome|ZOSTAVAX™ With PGSU|ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
1236318|NCT00130793|O2|Outcome|ZOSTAVAX™ With PGS|ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
1236319|NCT00130793|O1|Outcome|ZOSTAVAX™ With PGSU|ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
1236320|NCT00130793|E2|Reported Event|ZOSTAVAX™ With PGS|ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
1236321|NCT00130793|E1|Reported Event|ZOSTAVAX™ With PGSU|ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
1236322|NCT00130780|B3|Baseline|Total|Total of all reporting groups
1236323|NCT00130780|B2|Baseline|B: Pre-Surgical Docetaxel, Cisplatin, and Adjuvant Bevacizumab|"Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab~Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab: Patients will receive preoperative 21-day cycles of cisplatin (75 mg/m2) and docetaxel (75 mg/m2) both given on Day 1 of each cycle.Patients will undergo repeat CT imaging after 2 cycles of therapy and patients with at least 10% reduction in bidimensional tumor volume will receive 2 additional neoadjuvant cycles of therapy (total 4 cycles of therapy).Surgery will occur at least 4 weeks after the last treatment with docetaxel and cisplatin.Adjuvant bevacizumab (15 mg/kg q21 days for 1 year, total 18 cycles) will be administered to all patients who undergo resection. Adjuvant bevacizumab will begin between days 42 and 56 after surgery.Patients may be referred for post-operative radiation therapy at the discretion of the treating physician. Every attempt will be made to administer the treatment on schedule. The treatment may be given +/- 3 days, and additionally"
1236355|NCT00130520|B1|Baseline|Bevacizumab and Erlotinib|This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
1236356|NCT00130520|P1|Participant Flow|Bevacizumab and Erlotinib|This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
1236498|NCT00129766|O1|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236324|NCT00130780|B1|Baseline|A: Pre-surgical Treatment With Bevacizumab Plus Chemotherapy|"Pre-surgical Treatment with Bevacizumab plus Chemotherapy~Pre-surgical Treatment with Bevacizumab + Chemotherapy: On Cycle 1 Day 1,patient will receive bevacizumab 15 mg/kg. On Cycle 1 Day 15, patients receive docetaxel (75 mg/m2), cisplatin (75 mg/m2). Cycle 2 begins 21 days after administration of docetaxel and cisplatin in Cycle 1. In Cycles 2 thru 3, patients will receive 2 preoperative 21-day cycles of docetaxel (75 mg/m2), cisplatin (75 mg/m2), and bevacizumab (15 mg/kg), all given on Day 1 of each cycle. The sequence of administration will be docetaxel, followed by cisplatin, followed by bevacizumab according to MSKCC Chemotherapy Guidelines. In Cycle 4 Day 1, patients will receive docetaxel (75 mg/m2) and cisplatin (75 mg/m2). Bevacizumab will not be given with Cycle 4. During Cycle 4, the only scheduled clinic visit will be on Day 1. Surgery will occur at least 42 days after the last treatment with bevacizumab. Every attempt will be made to administer the treatment on sc"
1236325|NCT00130780|P2|Participant Flow|B: Pre-Surgical Docetaxel, Cisplatin, and Adjuvant Bevacizumab|"Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab~Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab: Patients will receive preoperative 21-day cycles of cisplatin (75 mg/m2) and docetaxel (75 mg/m2) both given on Day 1 of each cycle.Patients will undergo repeat CT imaging after 2 cycles of therapy and patients with at least 10% reduction in bidimensional tumor volume will receive 2 additional neoadjuvant cycles of therapy (total 4 cycles of therapy).Surgery will occur at least 4 weeks after the last treatment with docetaxel and cisplatin.Adjuvant bevacizumab (15 mg/kg q21 days for 1 year, total 18 cycles) will be administered to all patients who undergo resection. Adjuvant bevacizumab will begin between days 42 and 56 after surgery.Patients may be referred for post-operative radiation therapy at the discretion of the treating physician. Every attempt will be made to administer the treatment on schedule. The treatment may be given +/- 3 days, and additionally"
1236326|NCT00130780|P1|Participant Flow|A: Pre-surgical Treatment With Bevacizumab Plus Chemotherapy|"Pre-surgical Treatment with Bevacizumab plus Chemotherapy~Pre-surgical Treatment with Bevacizumab + Chemotherapy: On Cycle 1 Day 1,patient will receive bevacizumab 15 mg/kg. On Cycle 1 Day 15, patients receive docetaxel (75 mg/m2), cisplatin (75 mg/m2). Cycle 2 begins 21 days after administration of docetaxel and cisplatin in Cycle 1. In Cycles 2 thru 3, patients will receive 2 preoperative 21-day cycles of docetaxel (75 mg/m2), cisplatin (75 mg/m2), and bevacizumab (15 mg/kg), all given on Day 1 of each cycle. The sequence of administration will be docetaxel, followed by cisplatin, followed by bevacizumab according to MSKCC Chemotherapy Guidelines. In Cycle 4 Day 1, patients will receive docetaxel (75 mg/m2) and cisplatin (75 mg/m2). Bevacizumab will not be given with Cycle 4. During Cycle 4, the only scheduled clinic visit will be on Day 1. Surgery will occur at least 42 days after the last treatment with bevacizumab. Every attempt will be made to administer the treatment on sc"
1236347|NCT00130689|P1|Participant Flow|Cetuximab|Patients received cetuximab at an initial dose of 400 mg/m2 administered IV over 120 min, followed by weekly infusions at 250 mg/m2 administered IV over 60 min. Once cycle was 4 weeks of therapy. Patients received treatment until disease progression or unacceptable toxicity.
1236724|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day
1236327|NCT00130780|O2|Outcome|B: Pre-Surgical Docetaxel, Cisplatin, and Adjuvant Bevacizumab|"Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab~Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab: Patients will receive preoperative 21-day cycles of cisplatin (75 mg/m2) and docetaxel (75 mg/m2) both given on Day 1 of each cycle.Patients will undergo repeat CT imaging after 2 cycles of therapy and patients with at least 10% reduction in bidimensional tumor volume will receive 2 additional neoadjuvant cycles of therapy (total 4 cycles of therapy).Surgery will occur at least 4 weeks after the last treatment with docetaxel and cisplatin.Adjuvant bevacizumab (15 mg/kg q21 days for 1 year, total 18 cycles) will be administered to all patients who undergo resection. Adjuvant bevacizumab will begin between days 42 and 56 after surgery.Patients may be referred for post-operative radiation therapy at the discretion of the treating physician. Every attempt will be made to administer the treatment on schedule. The treatment may be given +/- 3 days, and additionally"
1236328|NCT00130780|O1|Outcome|A: Pre-surgical Treatment With Bevacizumab Plus Chemotherapy|"Pre-surgical Treatment with Bevacizumab plus Chemotherapy~Pre-surgical Treatment with Bevacizumab + Chemotherapy: On Cycle 1 Day 1,patient will receive bevacizumab 15 mg/kg. On Cycle 1 Day 15, patients receive docetaxel (75 mg/m2), cisplatin (75 mg/m2). Cycle 2 begins 21 days after administration of docetaxel and cisplatin in Cycle 1. In Cycles 2 thru 3, patients will receive 2 preoperative 21-day cycles of docetaxel (75 mg/m2), cisplatin (75 mg/m2), and bevacizumab (15 mg/kg), all given on Day 1 of each cycle. The sequence of administration will be docetaxel, followed by cisplatin, followed by bevacizumab according to MSKCC Chemotherapy Guidelines. In Cycle 4 Day 1, patients will receive docetaxel (75 mg/m2) and cisplatin (75 mg/m2). Bevacizumab will not be given with Cycle 4. During Cycle 4, the only scheduled clinic visit will be on Day 1. Surgery will occur at least 42 days after the last treatment with bevacizumab. Every attempt will be made to administer the treatment on sc"
1236329|NCT00130780|E2|Reported Event|B: Pre-Surgical Docetaxel, Cisplatin, and Adjuvant Bevacizumab|"Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab~Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab: Patients will receive preoperative 21-day cycles of cisplatin (75 mg/m2) and docetaxel (75 mg/m2) both given on Day 1 of each cycle.Patients will undergo repeat CT imaging after 2 cycles of therapy and patients with at least 10% reduction in bidimensional tumor volume will receive 2 additional neoadjuvant cycles of therapy (total 4 cycles of therapy).Surgery will occur at least 4 weeks after the last treatment with docetaxel and cisplatin.Adjuvant bevacizumab (15 mg/kg q21 days for 1 year, total 18 cycles) will be administered to all patients who undergo resection. Adjuvant bevacizumab will begin between days 42 and 56 after surgery.Patients may be referred for post-operative radiation therapy at the discretion of the treating physician. Every attempt will be made to administer the treatment on schedule. The treatment may be given +/- 3 days, and additionally"
1236357|NCT00130520|O1|Outcome|Bevacizumab and Erlotinib|This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
1236358|NCT00130520|O1|Outcome|Bevacizumab and Erlotinib|This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
1250395|NCT00091793|O2|Outcome|Placebo|
1236330|NCT00130780|E1|Reported Event|A: Pre-surgical Treatment With Bevacizumab Plus Chemotherapy|"Pre-surgical Treatment with Bevacizumab plus Chemotherapy~Pre-surgical Treatment with Bevacizumab + Chemotherapy: On Cycle 1 Day 1,patient will receive bevacizumab 15 mg/kg. On Cycle 1 Day 15, patients receive docetaxel (75 mg/m2), cisplatin (75 mg/m2). Cycle 2 begins 21 days after administration of docetaxel and cisplatin in Cycle 1. In Cycles 2 thru 3, patients will receive 2 preoperative 21-day cycles of docetaxel (75 mg/m2), cisplatin (75 mg/m2), and bevacizumab (15 mg/kg), all given on Day 1 of each cycle. The sequence of administration will be docetaxel, followed by cisplatin, followed by bevacizumab according to MSKCC Chemotherapy Guidelines. In Cycle 4 Day 1, patients will receive docetaxel (75 mg/m2) and cisplatin (75 mg/m2). Bevacizumab will not be given with Cycle 4. During Cycle 4, the only scheduled clinic visit will be on Day 1. Surgery will occur at least 42 days after the last treatment with bevacizumab. Every attempt will be made to administer the treatment on sc"
1236331|NCT00130728|B3|Baseline|Total|Total of all reporting groups
1236332|NCT00130728|B2|Baseline|Erlotinib HCl + Placebo|oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
1236333|NCT00130728|B1|Baseline|Erlotinib HCl + Bevacizumab|oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
1236334|NCT00130728|P2|Participant Flow|Erlotinib HCl + Placebo|oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
1236335|NCT00130728|P1|Participant Flow|Erlotinib HCl + Bevacizumab|oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
1236336|NCT00130728|O2|Outcome|Erlotinib HCl + Placebo|oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
1236337|NCT00130728|O1|Outcome|Erlotinib HCl + Bevacizumab|oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
1236338|NCT00130728|O2|Outcome|Erlotinib HCl + Placebo|oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
1236339|NCT00130728|O1|Outcome|Erlotinib HCl + Bevacizumab|oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
1236340|NCT00130728|O2|Outcome|Erlotinib HCl + Placebo|oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
1236341|NCT00130728|O1|Outcome|Erlotinib HCl + Bevacizumab|oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
1236342|NCT00130728|O2|Outcome|Erlotinib HCl + Placebo|oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
1236343|NCT00130728|O1|Outcome|Erlotinib HCl + Bevacizumab|oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
1236344|NCT00130728|E2|Reported Event|Erlotinib HCl + Placebo|oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
1236345|NCT00130728|E1|Reported Event|Erlotinib HCl + Bevacizumab|oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
1236346|NCT00130689|B1|Baseline|Cetuximab|Patients received cetuximab at an initial dose of 400 mg/m2 administered IV over 120 min, followed by weekly infusions at 250 mg/m2 administered IV over 60 min. Once cycle was 4 weeks of therapy. Patients received treatment until disease progression or unacceptable toxicity.
1236348|NCT00130689|O1|Outcome|Cetuximab|Patients received cetuximab at an initial dose of 400 mg/m2 administered IV over 120 min, followed by weekly infusions at 250 mg/m2 administered IV over 60 min. Once cycle was 4 weeks of therapy. Patients received treatment until disease progression or unacceptable toxicity.
1236349|NCT00130689|E1|Reported Event|Cetuximab|Patients received cetuximab at an initial dose of 400 mg/m2 administered IV over 120 min, followed by weekly infusions at 250 mg/m2 administered IV over 60 min. Once cycle was 4 weeks of therapy. Patients received treatment until disease progression or unacceptable toxicity.
1236350|NCT00130637|B1|Baseline|Daclizumab|An induction regimen of intravenous (IV) daclizumab at 8 mg/kg was given on Day 0 followed by another IV dose of 4 mg/kg at Day 14, provided the safety endpoint was not met. Participants who showed a two-step reduction in their ocular inflammation or a decrease to inactivity, without serious adverse events, had the option to receive extended treatments of 2 mg/kg IV daclizumab treatments at 4-week intervals, beginning day 28, for up to a total of 52 weeks.
1236351|NCT00130637|P1|Participant Flow|Daclizumab|An induction regimen of intravenous (IV) daclizumab at 8 mg/kg was given on Day 0 followed by another IV dose of 4 mg/kg at Day 14, provided the safety endpoint was not met. Participants who showed a two-step reduction in their ocular inflammation or a decrease to inactivity, without serious adverse events, had the option to receive extended treatments of 2 mg/kg IV daclizumab treatments at 4-week intervals, beginning day 28, for up to a total of 52 weeks.
1236352|NCT00130637|O1|Outcome|Daclizumab|An induction regimen of intravenous (IV) daclizumab at 8 mg/kg was given on Day 0 followed by another IV dose of 4 mg/kg at Day 14, provided the safety endpoint was not met. Participants who showed a two-step reduction in their ocular inflammation or a decrease to inactivity, without serious adverse events, had the option to receive extended treatments of 2 mg/kg IV daclizumab treatments at 4-week intervals, beginning day 28, for up to a total of 52 weeks.
1236353|NCT00130637|O1|Outcome|Daclizumab|An induction regimen of intravenous (IV) daclizumab at 8 mg/kg was given on Day 0 followed by another IV dose of 4 mg/kg at Day 14, provided the safety endpoint was not met. Participants who showed a two-step reduction in their ocular inflammation or a decrease to inactivity, without serious adverse events, had the option to receive extended treatments of 2 mg/kg IV daclizumab treatments at 4-week intervals, beginning day 28, for up to a total of 52 weeks.
1236354|NCT00130637|E1|Reported Event|Daclizumab|An induction regimen of intravenous (IV) daclizumab at 8 mg/kg was given on Day 0 followed by another IV dose of 4 mg/kg at Day 14, provided the safety endpoint was not met. Participants who showed a two-step reduction in their ocular inflammation or a decrease to inactivity, without serious adverse events, had the option to receive extended treatments of 2 mg/kg IV daclizumab treatments at 4-week intervals, beginning day 28, for up to a total of 52 weeks.
1236359|NCT00130520|O1|Outcome|Bevacizumab and Erlotinib|This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
1236360|NCT00130520|E1|Reported Event|Bevacizumab and Erlotinib|This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
1236361|NCT00130286|B5|Baseline|Total|Total of all reporting groups
1236362|NCT00130286|B4|Baseline|Double Placebo|"Placebo for recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
1236363|NCT00130286|B3|Baseline|rhGH + Rosi Placebo|"Recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
1236364|NCT00130286|B2|Baseline|rhGH Placebo + Rosi|"Placebo for recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
1236365|NCT00130286|B1|Baseline|rhGH + Rosi|"Recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
1236366|NCT00130286|P4|Participant Flow|Double Placebo|"Placebo for recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
1236392|NCT00130247|O1|Outcome|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
1236367|NCT00130286|P3|Participant Flow|rhGH + Rosi Placebo|"Recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
1236368|NCT00130286|P2|Participant Flow|rhGH Placebo + Rosi|"Placebo for recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
1236369|NCT00130286|P1|Participant Flow|rhGH + Rosi|"Recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
1236370|NCT00130286|O4|Outcome|Double Placebo|"Placebo for recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
1236371|NCT00130286|O3|Outcome|rhGH + Rosi Placebo|"Recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
1236372|NCT00130286|O2|Outcome|rhGH Placebo + Rosi|"Placebo for recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
1236373|NCT00130286|O1|Outcome|rhGH + Rosi|"Recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
1236374|NCT00130286|O4|Outcome|Double Placebo|"Placebo for recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
1236375|NCT00130286|O3|Outcome|rhGH + Rosi Placebo|"Recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
1236376|NCT00130286|O2|Outcome|rhGH Placebo + Rosi|"Placebo for recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
1236377|NCT00130286|O1|Outcome|rhGH + Rosi|"Recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
1236378|NCT00130286|O4|Outcome|Double Placebo|"Placebo for recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
1236379|NCT00130286|O3|Outcome|rhGH + Rosi Placebo|"Recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
1236380|NCT00130286|O2|Outcome|rhGH Placebo + Rosi|"Placebo for recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
1236381|NCT00130286|O1|Outcome|rhGH + Rosi|"Recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
1236382|NCT00130286|E4|Reported Event|Double Placebo|"Placebo for recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
1236383|NCT00130286|E3|Reported Event|rhGH + Rosi Placebo|"Recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
1236384|NCT00130286|E2|Reported Event|rhGH Placebo + Rosi|"Placebo for recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
1236385|NCT00130286|E1|Reported Event|rhGH + Rosi|"Recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
1236386|NCT00130247|B3|Baseline|Total|Total of all reporting groups
1236387|NCT00130247|B2|Baseline|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
1236388|NCT00130247|B1|Baseline|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
1236389|NCT00130247|P2|Participant Flow|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
1236390|NCT00130247|P1|Participant Flow|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
1236391|NCT00130247|O2|Outcome|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
1236517|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236393|NCT00130247|O2|Outcome|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
1236394|NCT00130247|O1|Outcome|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
1236395|NCT00130247|O2|Outcome|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
1236396|NCT00130247|O1|Outcome|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
1236397|NCT00130247|O2|Outcome|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
1236398|NCT00130247|O1|Outcome|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
1236399|NCT00130247|O2|Outcome|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
1236400|NCT00130247|O1|Outcome|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
1236401|NCT00130247|O2|Outcome|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
1236402|NCT00130247|O1|Outcome|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
1236403|NCT00130247|E2|Reported Event|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
1236404|NCT00130247|E1|Reported Event|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
1236405|NCT00130117|B3|Baseline|Total|Total of all reporting groups
1236406|NCT00130117|B2|Baseline|Placebo|"placebo~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.~Placebo: placebo (no active medication)"
1236407|NCT00130117|B1|Baseline|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.~r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
1236408|NCT00130117|P2|Participant Flow|Placebo|"placebo~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.~Placebo: placebo (no active medication)"
1236409|NCT00130117|P1|Participant Flow|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.~r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
1236410|NCT00130117|O2|Outcome|Placebo|"placebo~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.~Placebo: placebo (no active medication)"
1236411|NCT00130117|O1|Outcome|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.~r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
1236412|NCT00130117|O2|Outcome|Placebo|"placebo~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.~Placebo: placebo (no active medication)"
1236413|NCT00130117|O1|Outcome|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.~r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
1236414|NCT00130117|O2|Outcome|Placebo|"placebo~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.~Placebo: placebo (no active medication)"
1236415|NCT00130117|O1|Outcome|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.~r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
1236417|NCT00130117|O1|Outcome|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.~r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
1236418|NCT00130117|O2|Outcome|Placebo|"placebo~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.~Placebo: placebo (no active medication)"
1236419|NCT00130117|O1|Outcome|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.~r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
1236420|NCT00130117|O2|Outcome|Placebo|"placebo~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.~Placebo: placebo (no active medication)"
1236421|NCT00130117|O1|Outcome|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.~r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
1236422|NCT00130117|O2|Outcome|Placebo|"placebo~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.~Placebo: placebo (no active medication)"
1236423|NCT00130117|O1|Outcome|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.~r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
1236424|NCT00130117|O1|Outcome|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.~r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
1236425|NCT00130117|O2|Outcome|Placebo|"placebo~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.~Placebo: placebo (no active medication)"
1236426|NCT00130117|O1|Outcome|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.~r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
1236427|NCT00130117|E2|Reported Event|Placebo|"placebo~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily.~Placebo: placebo (no active medication)"
1236518|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236725|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day
1236428|NCT00130117|E1|Reported Event|r-metHuLeptin|"r-metHuLeptin administered subcutaneously.~r-metHuLeptin: Starting dose: 0.08mg/kg once daily Subcutaneous injection.~Oral Contraceptive Pills (OCPs): Sprintec taken orally once daily."
1236429|NCT00130039|B3|Baseline|Total|Total of all reporting groups
1236430|NCT00130039|B2|Baseline|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
1236431|NCT00130039|B1|Baseline|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
1236432|NCT00130039|P2|Participant Flow|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
1236433|NCT00130039|P1|Participant Flow|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
1236434|NCT00130039|O2|Outcome|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
1236435|NCT00130039|O1|Outcome|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
1236436|NCT00130039|O2|Outcome|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
1236437|NCT00130039|O1|Outcome|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
1236438|NCT00130039|O2|Outcome|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
1236439|NCT00130039|O1|Outcome|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
1236440|NCT00130039|O2|Outcome|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
1236441|NCT00130039|O1|Outcome|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
1236442|NCT00130039|O2|Outcome|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
1236443|NCT00130039|O1|Outcome|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
1236444|NCT00130039|O2|Outcome|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
1236445|NCT00130039|O1|Outcome|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
1236446|NCT00130039|E2|Reported Event|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
1236447|NCT00130039|E1|Reported Event|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
1236448|NCT00129974|B1|Baseline|Arm 1|Pemetrexed and Gemcitabine
1236449|NCT00129974|P1|Participant Flow|Arm 1|Pemetrexed and Gemcitabine
1236450|NCT00129974|O1|Outcome|Arm 1|Pemetrexed and Gemcitabine
1236451|NCT00129974|O1|Outcome|Arm 1|Pemetrexed and Gemcitabine
1236452|NCT00129974|E1|Reported Event|Arm 1|
1236453|NCT00129961|B3|Baseline|Total|Total of all reporting groups
1236454|NCT00129961|B2|Baseline|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
1236455|NCT00129961|B1|Baseline|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
1236456|NCT00129961|P2|Participant Flow|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
1236457|NCT00129961|P1|Participant Flow|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
1236519|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236520|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236521|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236522|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236458|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
1236459|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
1236460|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
1236461|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
1236462|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
1250396|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
1236463|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
1236464|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
1236523|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236524|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236525|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236526|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1247984|NCT00098059|O4|Outcome|13 to <=18 Years|
1236465|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
1236466|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
1236467|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
1236468|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
1236469|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
1236470|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
1236471|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
1236527|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236528|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236529|NCT00129766|E2|Reported Event|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236530|NCT00129766|E1|Reported Event|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236472|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
1236473|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
1236474|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
1236475|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
1236476|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
1250397|NCT00091793|O2|Outcome|Placebo|
1236477|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
1236478|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
1236531|NCT00129727|B1|Baseline|Phase II of Carboplatin, Pacitaxel, and Bevacizumab|Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
1236532|NCT00129727|P1|Participant Flow|Phase II of Carboplatin, Pacitaxel, and Bevacizumab|Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
1236726|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
1236479|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
1236480|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
1236481|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
1236482|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
1236483|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
1236484|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
1236485|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
1236533|NCT00129727|O1|Outcome|Phase II of Carboplatin, Pacitaxel, and Bevacizumab|Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
1236534|NCT00129727|O1|Outcome|Phase II of Carboplatin, Pacitaxel, and Bevacizumab|Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
1236727|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
1236486|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
1236487|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
1236488|NCT00129961|E2|Reported Event|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
1236489|NCT00129961|E1|Reported Event|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
1236490|NCT00129766|B3|Baseline|Total|Total of all reporting groups
1236491|NCT00129766|B2|Baseline|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236492|NCT00129766|B1|Baseline|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236493|NCT00129766|P2|Participant Flow|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236494|NCT00129766|P1|Participant Flow|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236495|NCT00129766|O1|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236496|NCT00129766|O1|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236497|NCT00129766|O1|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236499|NCT00129766|O1|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236500|NCT00129766|O1|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236501|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236502|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236503|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236504|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236505|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236506|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236507|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236508|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236509|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236510|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236511|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236512|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236513|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236514|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236515|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236516|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
1236728|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
1236535|NCT00129727|O1|Outcome|Phase II of Carboplatin, Pacitaxel, and Bevacizumab|Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
1236536|NCT00129727|E1|Reported Event|Phase II of Carboplatin, Pacitaxel, and Bevacizumab|Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
1236537|NCT00129623|B3|Baseline|Total|Total of all reporting groups
1236538|NCT00129623|B2|Baseline|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
1236539|NCT00129623|B1|Baseline|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
1236540|NCT00129623|P2|Participant Flow|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
1236541|NCT00129623|P1|Participant Flow|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
1236542|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
1236543|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
1236544|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
1236545|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
1236546|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia who were administered 150 mg IBN tablet orally (PO) once monthly. All participants received 500 mg/d calcium and 400 international units [IU]/d vitamin D as dietary supplements consisting of one tablet a day of OSCAL for the duration of the study. Participants received 12 months of treatment and were followed for an additional period of 15 days.
1236547|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia who were administered matching placebo tablet PO once monthly. All participants received 500 mg/d calcium and 400 international units [IU]/d vitamin D as dietary supplements consisting of one tablet a day of OSCAL for the duration of the study. Participants received 12 months of treatment and were followed for an additional period of 15 days.
1250398|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
1236548|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
1236549|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
1236550|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
1236551|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
1236552|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
1236637|NCT00129402|O1|Outcome|Pooled Subjects Who Received Ezetimibe With Simvastatin|Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
1247985|NCT00098059|O3|Outcome|6 to <13 Years|
1236553|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
1236554|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
1236555|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
1236556|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
1236557|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
1236558|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
1236559|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
1236560|NCT00129623|E2|Reported Event|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
1236561|NCT00129623|E1|Reported Event|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
1236562|NCT00129545|B4|Baseline|Total|Total of all reporting groups
1236563|NCT00129545|B3|Baseline|Roll-in|Subjects received WATCHMAN Left Atrial Appendage Closure Technology but were not included in the outcome analysis
1236564|NCT00129545|B2|Baseline|Warfarin Control|Subjects were treated with current standard of care Oral Anticoagulation Therapy with Warfarin
1236565|NCT00129545|B1|Baseline|WATCHMAN|WATCHMAN Left Atrial Appendage Closure Technology:
1236566|NCT00129545|P3|Participant Flow|WARFARIN|Randomized to receive Warfarin control
1236567|NCT00129545|P2|Participant Flow|WATCHMAN|Randomized to receive implantation of the WATCHMAN left atrial appendage (LAA) closure Technology
1236568|NCT00129545|P1|Participant Flow|Roll-in|Investigational centers were allowed up to 3 roll in subjects before initiating the randomization phase
1250399|NCT00091793|O2|Outcome|Placebo|
1236569|NCT00129545|O1|Outcome|WATCHMAN|"Implantable WATCHMAN Left ATrial Appendage Occlusion Device~Implant of WATCHMAN Left Atrial Appendage Closure Technology"
1236570|NCT00129545|O2|Outcome|Warfarin Control|"Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin~Warfarin: Subjects receive warfarin"
1236571|NCT00129545|O1|Outcome|Implantable Device|"Implantable WATCHMAN Left ATrial Appendage Occlusion Device~WATCHMAN Left Atrial Appendage Closure Technology: Implant of WATCHMAN Left Atrial Appendage Closure Technology"
1236572|NCT00129545|O2|Outcome|Warfarin Control|"Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin~Warfarin: Subjects receive warfarin"
1236573|NCT00129545|O1|Outcome|Implantable Device|"Implantable WATCHMAN Left ATrial Appendage Occlusion Device~WATCHMAN Left Atrial Appendage Closure Technology: Implant of WATCHMAN Left Atrial Appendage Closure Technology"
1236574|NCT00129545|E3|Reported Event|WARFARIN|Randomized to receive Warfarin control
1236575|NCT00129545|E2|Reported Event|WATCHMAN|Randomized to receive implantation of the WATCHMAN LAA closure Device
1236576|NCT00129545|E1|Reported Event|Roll-in|Investigational centers were allowed up to 3 roll in subjects before initiating the randomization phase
1236577|NCT00129480|B3|Baseline|Total|Total of all reporting groups
1236578|NCT00129480|B2|Baseline|Treatment as Usual|Treatment as usual which includes standard pain care, clinician generated referrals for additional consultation and ancillary services
1236579|NCT00129480|B1|Baseline|Assistance With Pain Treatment|"Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers~Assistance with Pain treatment: Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months."
1236580|NCT00129480|P2|Participant Flow|Treatment as Usual|Treatment as usual
1236638|NCT00129402|O2|Outcome|Pooled Subjects Who Received Simvastatin Monotherapy|Pooled subjects who received ezetimibe placebo plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
1236729|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
1236581|NCT00129480|P1|Participant Flow|Assistance With Pain Treatment|"Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers~Assistance with Pain treatment: Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months."
1236582|NCT00129480|O2|Outcome|Treatment as Usual|Pain treatment as usual
1236583|NCT00129480|O1|Outcome|Assistance With Pain Treatment (Intervention)|"Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers~Assistance with Pain treatment: Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months."
1236584|NCT00129480|E2|Reported Event|Treatment as Usual|Treatment as usual, which includes standard pain care, clinician-generated referrals for additional consultation and ancillary services
1236585|NCT00129480|E1|Reported Event|Assistance With Pain Treatment|"Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers~Assistance with Pain treatment: Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months."
1236586|NCT00129467|B3|Baseline|Total|Total of all reporting groups
1236587|NCT00129467|B2|Baseline|Placebo + SSRI|During the 18-day blind treatment period, subjects will be prescribed placebo 1-2 capsules twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram.
1236588|NCT00129467|B1|Baseline|Methylphenidate + SSRI|During the 18-day blind treatment period, subjects will be prescribed Methylphenidate 5-10 mg twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram. Subjects who respond to methylphenidate treatment will have the option of continuing on methylphenidate, up to 15 mg bid, and an antidepressant in the 6 week open label portion of the study.
1236589|NCT00129467|P2|Participant Flow|Placebo + SSRI|During the 18-day blind treatment period, subjects will be prescribed placebo 1-2 capsules twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram.
1236590|NCT00129467|P1|Participant Flow|Methylphenidate + SSRI|During the 18-day blind treatment period, subjects will be prescribed Methylphenidate 5-10 mg twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram. Subjects who respond to methylphenidate treatment will have the option of continuing on methylphenidate, up to 15 mg bid, and an antidepressant in the 6 week open label portion of the study.
1236591|NCT00129467|O2|Outcome|Placebo + SSRI|During the 18-day blind treatment period, subjects will be prescribed placebo 1-2 capsules twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram.
1236592|NCT00129467|O1|Outcome|Methylphenidate + SSRI|During the 18-day blind treatment period, subjects will be prescribed Methylphenidate 5-10 mg twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram. Subjects who respond to methylphenidate treatment will have the option of continuing on methylphenidate, up to 15 mg bid, and an antidepressant in the 6 week open label portion of the study.
1236621|NCT00129402|P7|Participant Flow|Long-term Experience Ezetimbe/Simvastatin|Subjects who received long-term coadministration of ezetimibe with simvastatin once daily
1238199|NCT00126776|P1|Participant Flow|Disease Management for COPD|disease management for COPD
1236593|NCT00129467|E2|Reported Event|Placebo + SSRI|During the 18-day blind treatment period, subjects will be prescribed placebo 1-2 capsules twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram.
1236594|NCT00129467|E1|Reported Event|Methylphenidate + SSRI|During the 18-day blind treatment period, subjects will be prescribed Methylphenidate 5-10 mg twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram. Subjects who respond to methylphenidate treatment will have the option of continuing on methylphenidate, up to 15 mg bid, and an antidepressant in the 6 week open label portion of the study.
1236595|NCT00129441|B3|Baseline|Total|Total of all reporting groups
1236596|NCT00129441|B2|Baseline|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
1236597|NCT00129441|B1|Baseline|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
1236598|NCT00129441|P2|Participant Flow|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
1236599|NCT00129441|P1|Participant Flow|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
1236600|NCT00129441|O2|Outcome|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
1236601|NCT00129441|O1|Outcome|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
1236602|NCT00129441|O2|Outcome|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
1236603|NCT00129441|O1|Outcome|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
1236604|NCT00129441|O2|Outcome|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
1236605|NCT00129441|O1|Outcome|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
1236606|NCT00129441|O2|Outcome|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
1236607|NCT00129441|O1|Outcome|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
1236608|NCT00129441|O2|Outcome|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
1236609|NCT00129441|O1|Outcome|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
1236610|NCT00129441|O2|Outcome|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
1236611|NCT00129441|O1|Outcome|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
1236612|NCT00129441|O2|Outcome|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
1236613|NCT00129441|O1|Outcome|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
1236614|NCT00129441|O2|Outcome|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
1236615|NCT00129441|O1|Outcome|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
1236616|NCT00129441|E2|Reported Event|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
1236617|NCT00129441|E1|Reported Event|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
1236618|NCT00129402|B3|Baseline|Total|Total of all reporting groups
1236619|NCT00129402|B2|Baseline|Pooled Subjects Who Received Simvastatin Monotherapy|Pooled subjects who received ezetimibe placebo plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
1236620|NCT00129402|B1|Baseline|Pooled Subjects Who Received Ezetimibe With Simvastatin|Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
1238079|NCT00127413|B3|Baseline|Cognitive Behavioral Therapy-Integrated|Integrated treatment for comorbid chronic pain and PTSD
1236622|NCT00129402|P6|Participant Flow|Ezetimibe Matching Placebo/ Simvastatin 40|Subjects who received simvastatin monotherapy 40 mg once daily
1236623|NCT00129402|P5|Participant Flow|Ezetimibe Matching Placebo/ Simvastatin 20|Subjects who received simvastatin monotherapy 20 mg once daily
1236624|NCT00129402|P4|Participant Flow|Ezetimibe Matching Placebo/ Simvastatin 10|Subjects who received simvastatin monotherapy 10 mg once daily
1236625|NCT00129402|P3|Participant Flow|Ezetimibe/Simvastatin 10/40|Subjects who received ezetimibe 10 mg plus simvastatin 40 mg once daily
1236626|NCT00129402|P2|Participant Flow|Ezetimibe/Simvastatin 10/20|Subjects who received ezetimibe 10 mg with simvastatin 10 mg once daily
1236627|NCT00129402|P1|Participant Flow|Ezetimibe/Simvastatin 10/10|Subjects who received ezetimibe 10 mg plus simvastatin 10 mg once daily
1236628|NCT00129402|O2|Outcome|Pooled Subjects Who Received Simvastatin Monotherapy|Pooled subjects who received ezetimibe placebo plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
1236629|NCT00129402|O1|Outcome|Pooled Subjects Who Received Ezetimibe With Simvastatin|Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
1236630|NCT00129402|O2|Outcome|Pooled Subjects Who Received Simvastatin Monotherapy|Pooled subjects who received ezetimibe placebo plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
1236631|NCT00129402|O1|Outcome|Pooled Subjects Who Received Ezetimibe With Simvastatin|Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
1236632|NCT00129402|O2|Outcome|Pooled Subjects Who Received Simvastatin Monotherapy|Pooled subjects who received ezetimibe placebo plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
1236633|NCT00129402|O1|Outcome|Pooled Subjects Who Received Ezetimibe With Simvastatin|Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
1236634|NCT00129402|O2|Outcome|Pooled Subjects Who Received Simvastatin Monotherapy|Pooled subjects who received ezetimibe placebo plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
1236635|NCT00129402|O1|Outcome|Pooled Subjects Who Received Ezetimibe With Simvastatin|Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
1236636|NCT00129402|O2|Outcome|Pooled Subjects Who Received Simvastatin Monotherapy|pooled subjects who received simvastatin 10 mg monotherapy, simvastatin 20 mg monotherapy, or simvastatin 40 mg monotherapy
1236639|NCT00129402|O1|Outcome|Pooled Subjects Who Received Ezetimibe With Simvastatin|Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
1236640|NCT00129402|E3|Reported Event|Long-term Coadministration of Ezetimibe With Simvastatin|"Column 3 provides the combined AE data collected for~all subjects that participated during Period 3. One subject who entered Period 3 did not receive study medication and was not included in the analysis."
1236641|NCT00129402|E2|Reported Event|Simvastatin Monotherapy|"Column 2 provides the combined AE data collected for subjects in the simvastatin monotherapy treatment~groups during Period 1 and Period 2."
1236642|NCT00129402|E1|Reported Event|Ezetimibe With Simvastatin|Column 1 provides the combined AE data collected for subjects in the ezetimibe with simvastatin treatment groups during Period 1 and Period 2
1236643|NCT00129311|B3|Baseline|Total|Total of all reporting groups
1236644|NCT00129311|B2|Baseline|Placebo|"Placebo~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
1236645|NCT00129311|B1|Baseline|Selegiline|"Selegiline~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
1236646|NCT00129311|P2|Participant Flow|Placebo|"Placebo~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
1236647|NCT00129311|P1|Participant Flow|Selegiline|"Selegiline~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
1236648|NCT00129311|O2|Outcome|Placebo|"Placebo~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
1236649|NCT00129311|O1|Outcome|Selegiline|"Selegiline~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
1236650|NCT00129311|O2|Outcome|Placebo|"Placebo~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
1236651|NCT00129311|O1|Outcome|Selegiline|"Selegiline~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
1236652|NCT00129311|E2|Reported Event|Placebo|"Placebo~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
1236653|NCT00129311|E1|Reported Event|Selegiline|"Selegiline~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
1236654|NCT00129272|B3|Baseline|Total|Total of all reporting groups
1236655|NCT00129272|B2|Baseline|Matching Placebo|"Using a double-blind, randomized, placebo-controlled design, smokers received treatment with a matching placebo (to Bupropion-SR 150 mg) twice daily in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.~Placebo: Matching placebo (to Buproion-SR) twice daily for 9 weeks."
1236656|NCT00129272|B1|Baseline|Active Drug (Bupropion-SR)|"Using a double-blind, randomized, placebo-controlled design, smokers received active treatment with Bupropion-Sr (150 mg. twice daily) in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.~Bupropion-SR: 150mg tablets taken orally twice daily for 9 weeks."
1236657|NCT00129272|P2|Participant Flow|Matching Placebo|"This arm included placebo treatment twice daily for 9 weeks. Drug and placebo were compounded to look identical, masking both drug type and dosage.~All participants (both drug and placebo groups) received a modified version of the brief office intervention program for adolescent smokers, developed by the American Medical Association. Subjects met with a research counselor for 10 consecutive weekly sessions. The initial session (baseline visit) was 60 min. while the remaining sessions were 20-30 min. Each session was individualized to the needs of the adolescent, based on information gathered at the baseline assessment. The brief office intervention materials include checklists and guidelines for each session to assist the counselor in tailoring the session to the needs of the youth. It involved motivational interviewing, incorporating stages of change, peer and parental and other social influences; negative affect and other psychological factors, addiction and self-efficacy."
1236716|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
1236717|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
1236718|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
1236719|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
1247986|NCT00098059|O2|Outcome|2 to <6 Years|
1236658|NCT00129272|P1|Participant Flow|Active Drug (Burpropion-SR)|"In total 172 participants were recruited, and 144 were randomized.~Using a double-blind, randomized, placebo-controlled design, participants were randomized to active drug or placebo using the modified Efron’s biased coin toss method to ensure that the drug/placebo cells are balanced with respect to severe depression, presence of nicotine dependence symptoms and gender.~Participants received active treatment with Bupropion-SR (150 mg. twice daily) in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.~The participants had weekly visits with the target quitting date set for Day 8. The medication checks lasted about 30-45 minutes. The focus was on elicitation of smoking status, nicotine craving and withdrawal symptoms, depressive symptoms and side effects. Body weight and vital signs were measured as well as expired air for CO and urine cotinine levels. Plasma drug levels were obtained at 5 and 9 weeks of treatment."
1236659|NCT00129272|O2|Outcome|Matching Placebo|"Using a double-blind, randomized, placebo-controlled design, smokers received treatment with a matching placebo (to Bupropion-SR 150 mg) twice daily in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.~Placebo: Matching placebo (to Buproion-SR) twice daily for 9 weeks."
1236660|NCT00129272|O1|Outcome|Active Drug (Bupropion-SR)|"Using a double-blind, randomized, placebo-controlled design, smokers received active treatment with Bupropion-Sr (150 mg. twice daily) in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.~Bupropion-SR: 150mg tablets taken orally twice daily for 9 weeks."
1236661|NCT00129272|O2|Outcome|Matching Placebo|"Using a double-blind, randomized, placebo-controlled design, smokers received treatment with a matching placebo (to Bupropion-SR 150 mg) twice daily in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.~Placebo: Matching placebo (to Buproion-SR) twice daily for 9 weeks."
1236662|NCT00129272|O1|Outcome|Active Drug (Bupropion-SR)|"Using a double-blind, randomized, placebo-controlled design, smokers received active treatment with Bupropion-Sr (150 mg. twice daily) in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.~Bupropion-SR: 150mg tablets taken orally twice daily for 9 weeks."
1236663|NCT00129272|E2|Reported Event|Matching Placebo|"Using a double-blind, randomized, placebo-controlled design, smokers received treatment with a matching placebo (to Bupropion-SR 150 mg) twice daily in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.~Placebo: Matching placebo (to Buproion-SR) twice daily for 9 weeks."
1236664|NCT00129272|E1|Reported Event|Active Drug (Bupropion-SR)|"Using a double-blind, randomized, placebo-controlled design, smokers received active treatment with Bupropion-Sr (150 mg. twice daily) in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.~Bupropion-SR: 150mg tablets taken orally twice daily for 9 weeks."
1236665|NCT00129259|B3|Baseline|Total|Total of all reporting groups
1236666|NCT00129259|B2|Baseline|Diabetes Standard of Care Treatment|Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
1236667|NCT00129259|B1|Baseline|Anti-CD3 mAb Plus Diabetes Standard of Care Treatment|Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
1237238|NCT00128830|P1|Participant Flow|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
1236668|NCT00129259|P2|Participant Flow|Diabetes Standard of Care Treatment|"Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.~Iron supplementation was initiated status post treatment randomization."
1236669|NCT00129259|P1|Participant Flow|Anti-CD3 mAb Plus Diabetes Standard of Care Treatment|"Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.~Iron supplementation was initiated status post treatment randomization."
1236670|NCT00129259|O2|Outcome|Diabetes Standard of Care Treatment|Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
1236671|NCT00129259|O1|Outcome|Anti-CD3 mAb Plus Diabetes Standard of Care Treatment|Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
1236672|NCT00129259|O2|Outcome|Diabetes Standard of Care Treatment|Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
1247987|NCT00098059|O1|Outcome|1 to < 2 Years|
1236673|NCT00129259|O1|Outcome|Anti-CD3 mAb Plus Diabetes Standard of Care Treatment|Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
1236674|NCT00129259|O2|Outcome|Diabetes Standard of Care Treatment|Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
1236675|NCT00129259|O1|Outcome|Anti-CD3 mAb Plus Diabetes Standard of Care Treatment|Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
1236676|NCT00129259|E2|Reported Event|Diabetes Standard of Care Treatment|Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
1236677|NCT00129259|E1|Reported Event|Anti-CD3 mAb Plus Diabetes Standard of Care Treatment|Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
1236678|NCT00129246|B3|Baseline|Total|Total of all reporting groups
1236679|NCT00129246|B2|Baseline|Naltrexone +Bupropion|"The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).~Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
1236741|NCT00129129|P3|Participant Flow|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
1238200|NCT00126776|O2|Outcome|Usual Care|usual care
1236680|NCT00129246|B1|Baseline|Bupropion Only|"The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
1236681|NCT00129246|P2|Participant Flow|Naltrexone +Bupropion|"The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).~Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
1236682|NCT00129246|P1|Participant Flow|Bupropion Only|"The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
1236683|NCT00129246|O2|Outcome|Naltrexone +Bupropion|"The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).~Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
1236684|NCT00129246|O1|Outcome|Bupropion Only|"The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
1236720|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
1236721|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
1236722|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
1236685|NCT00129246|O2|Outcome|Naltrexone +Bupropion|"The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).~Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
1236686|NCT00129246|O1|Outcome|Bupropion Only|"The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
1236687|NCT00129246|O2|Outcome|Naltrexone +Bupropion|"The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).~Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
1236688|NCT00129246|O1|Outcome|Bupropion Only|"The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
1236689|NCT00129246|O2|Outcome|Naltrexone +Bupropion|"The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).~Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
1236690|NCT00129246|O1|Outcome|Bupropion Only|"The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
1236753|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236691|NCT00129246|E2|Reported Event|Naltrexone +Bupropion|"The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).~Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
1236692|NCT00129246|E1|Reported Event|Bupropion Only|"The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
1236693|NCT00129220|B4|Baseline|Total|Total of all reporting groups
1236694|NCT00129220|B3|Baseline|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
1236695|NCT00129220|B2|Baseline|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
1236696|NCT00129220|B1|Baseline|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
1236697|NCT00129220|P3|Participant Flow|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
1236698|NCT00129220|P2|Participant Flow|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
1236699|NCT00129220|P1|Participant Flow|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
1236700|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
1236701|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
1236702|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
1236703|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
1236704|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
1236705|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
1236706|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
1236707|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
1236708|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
1236709|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
1236710|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
1236711|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
1236712|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
1236713|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
1236714|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
1236715|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
1236730|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
1236731|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
1236732|NCT00129220|E3|Reported Event|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
1236733|NCT00129220|E2|Reported Event|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
1236734|NCT00129220|E1|Reported Event|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
1236735|NCT00129129|B4|Baseline|Total|Total of all reporting groups
1236736|NCT00129129|B3|Baseline|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
1236737|NCT00129129|B2|Baseline|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236738|NCT00129129|B1|Baseline|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh..
1236739|NCT00129129|P5|Participant Flow|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236740|NCT00129129|P4|Participant Flow|ActHIB/MenHibrix Group|Subjects primed with ActHIB vaccine who received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the fourth dose phase, Menhibrix and Prevnar vaccines were administered intramuscularly in the right and left upper thigh, respectively.
1237239|NCT00128830|O1|Outcome|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
1236742|NCT00129129|P2|Participant Flow|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236743|NCT00129129|P1|Participant Flow|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236744|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236745|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236746|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1247988|NCT00098059|O4|Outcome|13 to <=18 Years|
1236747|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236748|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236749|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236750|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236751|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236752|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236754|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236755|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236756|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236757|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236781|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1237283|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1247989|NCT00098059|O3|Outcome|6 to <13 Years|
1236758|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236759|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236760|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236761|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236762|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236763|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236799|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236764|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236765|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236766|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236767|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236768|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects primed with ActHIB vaccine who received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the fourth dose phase, Menhibrix and Prevnar vaccines were administered intramuscularly in the right and left upper thigh, respectively.
1236769|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236770|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236771|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236772|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236773|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236774|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236775|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236776|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236777|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236778|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236779|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236780|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1237284|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237408|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1236782|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236783|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236784|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236785|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236786|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236787|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236788|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236789|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236790|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236791|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236792|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1237285|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237680|NCT00128193|O12|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1236793|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236794|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236795|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236796|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236797|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236798|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236800|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236801|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236802|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236803|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1237286|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1238018|NCT00127803|O2|Outcome|Low Dose Vaccine Group|Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
1236804|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236805|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236806|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236807|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236808|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236809|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236810|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236811|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236812|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236813|NCT00129129|O3|Outcome|ActHIB/Menhibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236814|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236815|NCT00129129|O1|Outcome|Menhibrix Group|Subjects of 6-12 weeks of age received 3 doses of Menhibrix vaccine co-administered with Pediarix and Prevnar vaccines during the primary vaccination phase. Subjects received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the primary phase, Menhibrix vaccine was administered intramuscularly into the right upper thigh. Pediarix and Prevnar vaccines were administered intramuscularly into the left upper thigh and the left lower thigh, respectively. In the fourth dose phase, Menhibrix vaccine was administered by the same route at the same vaccination site and Prevnar was administered intramuscularly in the left upper thigh.
1247990|NCT00098059|O2|Outcome|2 to <6 Years|
1236816|NCT00129129|O3|Outcome|ActHIB/Menhibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236817|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236818|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236819|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects primed with ActHIB vaccine who received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the fourth dose phase, Menhibrix and Prevnar vaccines were administered intramuscularly in the right and left upper thigh, respectively.
1236820|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236821|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236822|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1238080|NCT00127413|B2|Baseline|Cognitive Processing Therapy-PTSD|Cognitive processing therapy for PTSD
1236823|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236824|NCT00129129|O1|Outcome|Menhibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236825|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236826|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236827|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236828|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236829|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236830|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236831|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236832|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236833|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236921|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
1238195|NCT00126776|B3|Baseline|Total|Total of all reporting groups
1236834|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236835|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236836|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236837|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects primed with ActHIB vaccine who received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the fourth dose phase, Menhibrix and Prevnar vaccines were administered intramuscularly in the right and left upper thigh, respectively.
1236838|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236839|NCT00129129|O1|Outcome|Menhibrix Group|Subjects of 6-12 weeks of age received 3 doses of Menhibrix vaccine co-administered with Pediarix and Prevnar vaccines during the primary vaccination phase. Subjects received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the primary phase, Menhibrix vaccine was administered intramuscularly into the right upper thigh. Pediarix and Prevnar vaccines were administered intramuscularly into the left upper thigh and the left lower thigh, respectively. In the fourth dose phase, Menhibrix vaccine was administered by the same route at the same vaccination site and Prevnar was administered intramuscularly in the left upper thigh.
1237287|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1236840|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236841|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236842|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236843|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236844|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236845|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236846|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236847|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236848|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236849|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1237288|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1238019|NCT00127803|O1|Outcome|Placebo Group|Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
1236850|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236851|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236852|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236853|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236854|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
1237225|NCT00128921|O1|Outcome|Cohort A|Cohort A: Received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11.
1238196|NCT00126776|B2|Baseline|Usual Care|usual care
1236855|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236856|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236857|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
1236858|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236859|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1237289|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1236860|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236861|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236862|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236863|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1237226|NCT00128921|O2|Outcome|Cohort B|Cohort B: Received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11.
1237227|NCT00128921|O1|Outcome|Cohort A|Cohort A: Received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11.
1250400|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
1236864|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236865|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236866|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236867|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236868|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1238025|NCT00127790|B4|Baseline|Wait-List Control (WL)|Waitlist Control condition (WL) with no contact during the intervention period.
1236869|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236870|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236871|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236872|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236873|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236874|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236875|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236876|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236877|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236878|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236879|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236880|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236881|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236882|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236883|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236884|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236885|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236886|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1238390|NCT00126113|O2|Outcome|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
1236887|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236888|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236889|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236890|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236891|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236892|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236893|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236894|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236895|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236896|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236897|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236898|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236899|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1237228|NCT00128921|O2|Outcome|Cohort B|Cohort B: Received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11).
1237229|NCT00128921|O1|Outcome|Cohort A|Cohort A: Received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11.
1236900|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236901|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236902|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236903|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236904|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1237290|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1238020|NCT00127803|E4|Reported Event|High Dose Vaccine Group|Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
1236905|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236906|NCT00129129|O1|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
1236907|NCT00129129|O1|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
1236908|NCT00129129|O1|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
1236909|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
1236910|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1250401|NCT00091793|O2|Outcome|Placebo|
1236911|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236912|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
1236913|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236914|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236915|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
1236916|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236951|NCT00129116|P4|Participant Flow|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236917|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236918|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
1236919|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236920|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1237230|NCT00128921|O2|Outcome|Cohort B|Cohort B: Received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11.
1236922|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236923|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236924|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
1236925|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236926|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236927|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
1237291|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1238513|NCT00125164|B3|Baseline|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
1236928|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236929|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236930|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
1236931|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1237231|NCT00128921|O1|Outcome|Cohort A|Cohort A: Received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11.
1237232|NCT00128921|O2|Outcome|Cohort B|Cohort B: Parathyroid hormone (participants received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11 for three 21-day cycles)
1237233|NCT00128921|O1|Outcome|Cohort A|Cohort A: Parathyroid hormone (participants received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11 for three 21-day cycles)
1236932|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236933|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
1236934|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236935|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236936|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
1236937|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236952|NCT00129116|P3|Participant Flow|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237292|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1236938|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236939|NCT00129129|E5|Reported Event|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236940|NCT00129129|E4|Reported Event|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
1236941|NCT00129129|E3|Reported Event|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
1237234|NCT00128921|E3|Reported Event|Bortezomib, Cohort c|treatment: 0.7 mg/m^2
1237235|NCT00128921|E2|Reported Event|Bortezomib, Cohort b|treatment: 1.0 mg/m^2
1237236|NCT00128921|E1|Reported Event|Bortezomib, Cohort a|treatment: 1.3 mg/m^2
1237237|NCT00128830|B1|Baseline|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
1236942|NCT00129129|E2|Reported Event|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
1236943|NCT00129129|E1|Reported Event|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
1236944|NCT00129116|B6|Baseline|Total|Total of all reporting groups
1236945|NCT00129116|B5|Baseline|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236946|NCT00129116|B4|Baseline|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236947|NCT00129116|B3|Baseline|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236948|NCT00129116|B2|Baseline|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236949|NCT00129116|B1|Baseline|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236950|NCT00129116|P5|Participant Flow|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237261|NCT00128713|O1|Outcome|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
1236953|NCT00129116|P2|Participant Flow|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236954|NCT00129116|P1|Participant Flow|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236955|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236956|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236957|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236958|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236959|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236960|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236961|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236962|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236963|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236964|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236965|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237262|NCT00128713|O3|Outcome|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
1236966|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236967|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236968|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236969|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236970|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236971|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236972|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236973|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236974|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236975|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236976|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236977|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236978|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237263|NCT00128713|O2|Outcome|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
1238555|NCT00125164|O1|Outcome|Untreated|Observational Group
1236979|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236980|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236981|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236982|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236983|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236984|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236985|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236986|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236987|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236988|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236989|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236990|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236991|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237264|NCT00128713|O1|Outcome|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
1247991|NCT00098059|O1|Outcome|1 to < 2 Years|
1236992|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236993|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236994|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236995|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236996|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236997|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236998|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1236999|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237000|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237001|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237002|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237003|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237004|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237265|NCT00128713|O3|Outcome|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
1237005|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237006|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237007|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237008|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1250402|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
1237009|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237010|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237011|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237012|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237013|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237014|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237015|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237016|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237017|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237266|NCT00128713|O2|Outcome|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
1248313|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
1237018|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237019|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237020|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237021|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237022|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237023|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237024|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237025|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237026|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237027|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237028|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237029|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237030|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237267|NCT00128713|O1|Outcome|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
1248314|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
1237031|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237032|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237033|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237034|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237035|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237036|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237037|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237038|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237039|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237040|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237041|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237042|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237043|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237268|NCT00128713|O3|Outcome|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
1248315|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
1237044|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237045|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237046|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237047|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237048|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237049|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237050|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237051|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237052|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237053|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237054|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237055|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237056|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237269|NCT00128713|O2|Outcome|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
1248316|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
1237057|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237058|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237059|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237060|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237061|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237062|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237063|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237064|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237065|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237066|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237067|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237068|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237069|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237270|NCT00128713|O1|Outcome|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
1237070|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237071|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237072|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237073|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1250403|NCT00091793|O2|Outcome|Placebo|
1237074|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237075|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237076|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237077|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237078|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237079|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237080|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237081|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237082|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237271|NCT00128713|O3|Outcome|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
1248317|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
1237083|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237084|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237085|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237086|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237087|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237088|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237089|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237090|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237091|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237092|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237093|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237094|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237095|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237272|NCT00128713|O2|Outcome|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
1248318|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
1237096|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237097|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237098|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237099|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237100|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237101|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237102|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237103|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237104|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237105|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237106|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237107|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237108|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237273|NCT00128713|O1|Outcome|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
1248319|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
1237109|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237110|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237111|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237112|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237113|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237114|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237115|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237116|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237117|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237118|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237119|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237120|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237121|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237274|NCT00128713|E3|Reported Event|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
1248320|NCT00096785|E2|Reported Event|ETV 0.5 mg|
1237122|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237123|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237124|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237125|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237126|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237127|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237128|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237129|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237130|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237131|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237132|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237133|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237134|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237275|NCT00128713|E2|Reported Event|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
1237135|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237136|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237137|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237138|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1250404|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
1237139|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237140|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237141|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237142|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237143|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237144|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237145|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237146|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237147|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237276|NCT00128713|E1|Reported Event|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
1237277|NCT00128661|B3|Baseline|Total|Total of all reporting groups
1237148|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237149|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237150|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237151|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237152|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237153|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237154|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237155|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237156|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237157|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237158|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237159|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237160|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237278|NCT00128661|B2|Baseline|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237161|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237162|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237163|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237164|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237165|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237166|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237167|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237168|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237169|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237170|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237171|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237172|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237173|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237279|NCT00128661|B1|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237174|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237175|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237176|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237177|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237178|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237179|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237180|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237181|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237182|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237183|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237184|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237185|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237186|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237280|NCT00128661|P2|Participant Flow|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237187|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237188|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237189|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237190|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237191|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237192|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237193|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237194|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237195|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237196|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237197|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237198|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237199|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237281|NCT00128661|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237200|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237201|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237202|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237203|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237204|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237205|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237206|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237207|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237208|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237209|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237210|NCT00129116|E5|Reported Event|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237211|NCT00129116|E4|Reported Event|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237212|NCT00129116|E3|Reported Event|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237282|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237213|NCT00129116|E2|Reported Event|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237214|NCT00129116|E1|Reported Event|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
1237215|NCT00128921|B4|Baseline|Total|Total of all reporting groups
1237216|NCT00128921|B3|Baseline|Bortezomib, Cohort c|treatment: 0.7 mg/m^2
1237217|NCT00128921|B2|Baseline|Bortezomib, Cohort b|treatment: 1.0 mg/m^2
1237218|NCT00128921|B1|Baseline|Bortezomib, Cohort a|treatment: 1.3 mg/m^2
1237219|NCT00128921|P3|Participant Flow|Bortezomib, Cohort c|treatment: 0.7 mg/m^2
1237220|NCT00128921|P2|Participant Flow|Bortezomib, Cohort b|treatment: 1.0 mg/m^2
1237221|NCT00128921|P1|Participant Flow|Bortezomib, Cohort a|treatment: 1.3 mg/m^2
1237222|NCT00128921|O2|Outcome|Cohort B|Cohort B: Received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11.
1237223|NCT00128921|O1|Outcome|Cohort A|Cohort A: Received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11.
1237224|NCT00128921|O2|Outcome|Cohort B|Cohort B: Received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11.
1250405|NCT00091793|O2|Outcome|Placebo|
1237240|NCT00128830|O1|Outcome|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
1237241|NCT00128830|O1|Outcome|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
1237242|NCT00128830|O1|Outcome|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
1237243|NCT00128830|O1|Outcome|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
1237244|NCT00128830|O1|Outcome|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
1237245|NCT00128830|O1|Outcome|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
1237246|NCT00128830|O1|Outcome|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
1237247|NCT00128830|O2|Outcome|Viral Load Less Than 50 Copies/mL|Viral load less than 50 copies/mL at TMC125-C229 Baseline
1237248|NCT00128830|O1|Outcome|Viral Load More Than or Equal to 50 Copies/mL|Viral load more than or equal to 50 copies/mL at TMC125-C229 Baseline
1237249|NCT00128830|O2|Outcome|Viral Load Less Than 50 Copies/mL|Viral load less than 50 copies/mL at TMC125-C229 Baseline
1237250|NCT00128830|O1|Outcome|Viral Load More Than or Equal to 50 Copies/mL|Viral load more than or equal to 50 copies/mL at TMC125-C229 Baseline
1237251|NCT00128830|E1|Reported Event|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
1237252|NCT00128713|B4|Baseline|Total|Total of all reporting groups
1237253|NCT00128713|B3|Baseline|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
1237254|NCT00128713|B2|Baseline|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
1237255|NCT00128713|B1|Baseline|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
1237256|NCT00128713|P3|Participant Flow|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
1237257|NCT00128713|P2|Participant Flow|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
1237258|NCT00128713|P1|Participant Flow|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
1237259|NCT00128713|O3|Outcome|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
1237260|NCT00128713|O2|Outcome|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
1237293|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237294|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237295|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237296|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237297|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237298|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237299|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237300|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237301|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237302|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237303|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237304|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237305|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237306|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237307|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237308|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237309|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1238065|NCT00127712|O1|Outcome|Amiodarone|Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
1237310|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237311|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237312|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237313|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237314|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237315|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237316|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237317|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237318|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237319|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237320|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237321|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237322|NCT00128661|E2|Reported Event|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237323|NCT00128661|E1|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
1237324|NCT00128492|B3|Baseline|Total|Total of all reporting groups
1238021|NCT00127803|E3|Reported Event|Medium Dose Vaccine Group|Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
1237325|NCT00128492|B2|Baseline|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
1237326|NCT00128492|B1|Baseline|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
1237327|NCT00128492|P2|Participant Flow|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
1237328|NCT00128492|P1|Participant Flow|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
1237329|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
1237330|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
1237331|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
1237332|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
1237333|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
1237334|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
1237335|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
1237336|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
1237337|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
1237338|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
1237339|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
1237340|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
1237341|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
1237342|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
1237343|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
1237344|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
1237345|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
1237346|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
1237347|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
1237348|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
1237580|NCT00128193|O10|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237349|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
1237350|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
1237351|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
1237352|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
1237353|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
1237354|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
1237355|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
1237356|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
1237357|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
1237358|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
1237359|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
1237360|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
1237361|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
1237362|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
1237363|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
1237364|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
1237365|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
1237366|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
1237367|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
1237368|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
1237369|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
1237370|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
1237371|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
1237372|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
1237407|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237373|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
1237374|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
1237375|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
1237376|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
1237377|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
1237378|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
1237379|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
1237380|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
1237381|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
1237382|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
1237383|NCT00128492|E2|Reported Event|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
1237384|NCT00128492|E1|Reported Event|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
1237385|NCT00128401|B3|Baseline|Total|Total of all reporting groups
1237386|NCT00128401|B2|Baseline|Placebo|
1237387|NCT00128401|B1|Baseline|D-cycloserine|
1238066|NCT00127712|E2|Reported Event|Control|Control group
1237388|NCT00128401|P2|Participant Flow|Placebo|"Subjects were randomized to receive cognitive behavioral therapy with augmentation of placebo administered on day of therapy session.~All subjects underwent the same intake procedures and the same procedures for the assessments for baseline severity. Morever all subjects began the same psychotherapy procedures using cognitive behavioral therapy. After cognitive behavioral therapy was initiated subjects were randomized into a 1:1 ratio by the NIH pharmacy to enter either continued therapy with placebo or continued therapy with the active agent."
1237389|NCT00128401|P1|Participant Flow|D-cycloserine|Subjects were randomized to receive cognitive behavioral therapy with augmentation of D-cycloserine 50 mg administered on day of therapy session. All subjects underwent the same intake procedures and the same procedures for the assessments for baseline severity. Morever all subjects began the same psychotherapy procedures using cognitive behavioral therapy. After cognitive behavioral therapy was initiated subjects were randomized into a 1:1 ratio by the NIH pharmacy to enter either continued therapy with placebo or continued therapy with the active agent.
1237390|NCT00128401|O2|Outcome|Placebo|
1237391|NCT00128401|O1|Outcome|D-cycloserine|
1237392|NCT00128401|O2|Outcome|Placebo|
1237393|NCT00128401|O1|Outcome|D-cycloserine|
1237394|NCT00128401|E3|Reported Event|Not Assigned|
1237395|NCT00128401|E2|Reported Event|Placebo|
1237396|NCT00128401|E1|Reported Event|D-cycloserine|
1237397|NCT00128219|B3|Baseline|Total|Total of all reporting groups
1237398|NCT00128219|B2|Baseline|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237399|NCT00128219|B1|Baseline|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237400|NCT00128219|P2|Participant Flow|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237401|NCT00128219|P1|Participant Flow|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237402|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237403|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237404|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237405|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237406|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237409|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237410|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237411|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237412|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237413|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237414|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237415|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237416|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237417|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237418|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237419|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237420|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237421|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237422|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237423|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237424|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237425|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237426|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1238067|NCT00127712|E1|Reported Event|Amiodarone|Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
1237427|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237428|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237429|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237430|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237431|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237432|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237433|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237434|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237435|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237436|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237437|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237438|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237439|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237440|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237441|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237442|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237443|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237444|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1248321|NCT00096785|E1|Reported Event|ADV 10 mg|
1237445|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237446|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237447|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237448|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237449|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237450|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237451|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237452|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237453|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237454|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237455|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237456|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237457|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237458|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237459|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237460|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237461|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237462|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237463|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237464|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237465|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237466|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237467|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237468|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237469|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237470|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237471|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237472|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237473|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237474|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237475|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237476|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237477|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237478|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
1237479|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
1237581|NCT00128193|O9|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
1237480|NCT00128219|E2|Reported Event|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine). The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment.
1237481|NCT00128219|E1|Reported Event|GBS III-TT Vaccine|The experimental arm received a single dose of GBS III-TT vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment.
1237482|NCT00128206|B3|Baseline|Total|Total of all reporting groups
1237483|NCT00128206|B2|Baseline|Rifampin|rifampin (600 mg orally) given daily for 4 months
1237484|NCT00128206|B1|Baseline|Isoniazid|isoniazid (INH) (900 mg orally) given twice weekly for 9 months
1237485|NCT00128206|P2|Participant Flow|Rifampin|rifampin (600 mg orally) given daily for 4 months
1237486|NCT00128206|P1|Participant Flow|Isoniazid|isoniazid (INH) (900 mg orally) given twice weekly for 9 months
1237487|NCT00128206|O2|Outcome|Rifampin|rifampin (600 mg orally) given daily for 4 months
1237488|NCT00128206|O1|Outcome|Isoniazid|isoniazid (INH) (900 mg orally) given twice weekly for 9 months
1237489|NCT00128206|E2|Reported Event|Rifampin|rifampin (600 mg orally) given daily for 4 months
1237490|NCT00128206|E1|Reported Event|Isoniazid|isoniazid (INH) (900 mg orally) given twice weekly for 9 months
1237491|NCT00128193|B13|Baseline|Total|Total of all reporting groups
1237492|NCT00128193|B12|Baseline|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237493|NCT00128193|B11|Baseline|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237494|NCT00128193|B10|Baseline|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237495|NCT00128193|B9|Baseline|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
1237496|NCT00128193|B8|Baseline|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237497|NCT00128193|B7|Baseline|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237498|NCT00128193|B6|Baseline|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237499|NCT00128193|B5|Baseline|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237500|NCT00128193|B4|Baseline|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237501|NCT00128193|B3|Baseline|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237502|NCT00128193|B2|Baseline|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237503|NCT00128193|B1|Baseline|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
1237504|NCT00128193|P12|Participant Flow|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237505|NCT00128193|P11|Participant Flow|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237506|NCT00128193|P10|Participant Flow|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237507|NCT00128193|P9|Participant Flow|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
1237508|NCT00128193|P8|Participant Flow|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237509|NCT00128193|P7|Participant Flow|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237510|NCT00128193|P6|Participant Flow|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237511|NCT00128193|P5|Participant Flow|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237512|NCT00128193|P4|Participant Flow|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237513|NCT00128193|P3|Participant Flow|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237514|NCT00128193|P2|Participant Flow|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1238022|NCT00127803|E2|Reported Event|Low Dose Vaccine Group|Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
1237515|NCT00128193|P1|Participant Flow|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
1237516|NCT00128193|O8|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237517|NCT00128193|O7|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237518|NCT00128193|O6|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237519|NCT00128193|O5|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237520|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
1237521|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
1237522|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
1237523|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
1237524|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
1237525|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
1237526|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
1237527|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
1237528|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237529|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1238068|NCT00127530|B3|Baseline|Total|Total of all reporting groups
1238069|NCT00127530|B2|Baseline|Fampridine-SR|10 milligram (mg) tablet twice a day (b.i.d.)
1237530|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237531|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237532|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
1237533|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
1237534|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
1237535|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
1237536|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237537|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237538|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237539|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237540|NCT00128193|O8|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237541|NCT00128193|O7|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237542|NCT00128193|O6|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237543|NCT00128193|O5|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237544|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
1237545|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
1237546|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
1237582|NCT00128193|O8|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237547|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
1237548|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
1237549|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
1237550|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
1237551|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
1237552|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237553|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237554|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237555|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237556|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
1237557|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
1237558|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
1237559|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
1237560|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237561|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1238070|NCT00127530|B1|Baseline|Placebo- Sugar Pill|Placebo control group
1237562|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237563|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237564|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237565|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237566|NCT00128193|O2|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237567|NCT00128193|O1|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
1237568|NCT00128193|O10|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237569|NCT00128193|O9|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237570|NCT00128193|O8|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237571|NCT00128193|O7|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237572|NCT00128193|O6|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
1237573|NCT00128193|O5|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
1237574|NCT00128193|O4|Outcome|C1 - High Dose in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237575|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
1237576|NCT00128193|O2|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237577|NCT00128193|O1|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237578|NCT00128193|O12|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237579|NCT00128193|O11|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237583|NCT00128193|O7|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237584|NCT00128193|O6|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237585|NCT00128193|O5|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237586|NCT00128193|O4|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237587|NCT00128193|O3|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237588|NCT00128193|O2|Outcome|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237589|NCT00128193|O1|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
1237590|NCT00128193|O2|Outcome|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of M. leprae Cell Wall Antigen (MLCwA), 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237591|NCT00128193|O1|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
1237592|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237593|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237594|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237595|NCT00128193|O1|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237596|NCT00128193|O5|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237597|NCT00128193|O4|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237598|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237599|NCT00128193|O2|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237600|NCT00128193|O1|Outcome|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of M. leprae Cell Wall Antigen (MLCwA), 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237601|NCT00128193|O1|Outcome|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of M. leprae Cell Wall Antigen (MLCwA), 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237602|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237603|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237604|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237605|NCT00128193|O1|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237606|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237607|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237608|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237609|NCT00128193|O5|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237610|NCT00128193|O4|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237611|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237612|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237613|NCT00128193|O1|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237614|NCT00128193|O6|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237615|NCT00128193|O5|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237616|NCT00128193|O4|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237617|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237618|NCT00128193|O2|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237619|NCT00128193|O1|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
1237620|NCT00128193|O1|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
1237621|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237622|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237623|NCT00128193|O1|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237624|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237625|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237626|NCT00128193|O1|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237627|NCT00128193|O8|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237628|NCT00128193|O7|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237629|NCT00128193|O6|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237630|NCT00128193|O5|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
1237631|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237632|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237633|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237634|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237635|NCT00128193|O8|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237636|NCT00128193|O7|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237637|NCT00128193|O6|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237638|NCT00128193|O5|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
1237639|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237640|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237641|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237642|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237643|NCT00128193|O3|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237644|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237645|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237646|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237647|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237648|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237649|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237650|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237651|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237652|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237653|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237654|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237655|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237656|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237657|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237658|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237659|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237660|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237661|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237662|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237663|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237664|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237665|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237666|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237667|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237668|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237669|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237670|NCT00128193|O10|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237671|NCT00128193|O9|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237672|NCT00128193|O8|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237673|NCT00128193|O7|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237674|NCT00128193|O6|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
1237675|NCT00128193|O5|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
1237676|NCT00128193|O4|Outcome|C1 - High Dose in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237677|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
1237678|NCT00128193|O2|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237679|NCT00128193|O1|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1238556|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
1237681|NCT00128193|O11|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237682|NCT00128193|O10|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237683|NCT00128193|O9|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
1237684|NCT00128193|O8|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237685|NCT00128193|O7|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237686|NCT00128193|O6|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237687|NCT00128193|O5|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237688|NCT00128193|O4|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237689|NCT00128193|O3|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237690|NCT00128193|O2|Outcome|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237691|NCT00128193|O1|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
1237692|NCT00128193|O5|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237693|NCT00128193|O4|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237694|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237695|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237696|NCT00128193|O1|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237697|NCT00128193|O6|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237698|NCT00128193|O5|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237699|NCT00128193|O4|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237700|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237701|NCT00128193|O2|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237702|NCT00128193|O1|Outcome|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of M. leprae Cell Wall Antigen (MLCwA), 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237703|NCT00128193|O5|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237704|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237705|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237706|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
1237707|NCT00128193|O1|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237708|NCT00128193|O6|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237709|NCT00128193|O5|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237710|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237711|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
1237712|NCT00128193|O2|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1250589|NCT00092495|O1|Outcome|Girls 10-15 Years|
1237713|NCT00128193|O1|Outcome|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of M. leprae Cell Wall Antigen (MLCwA), 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237714|NCT00128193|O5|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237715|NCT00128193|O4|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237716|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237717|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237718|NCT00128193|O1|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237719|NCT00128193|O6|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237720|NCT00128193|O5|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237721|NCT00128193|O4|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237722|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237723|NCT00128193|O2|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237724|NCT00128193|O1|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
1237725|NCT00128193|O5|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237726|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237727|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237728|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
1237729|NCT00128193|O1|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237730|NCT00128193|O6|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237731|NCT00128193|O5|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237732|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237733|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
1237734|NCT00128193|O2|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237735|NCT00128193|O1|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
1237736|NCT00128193|E12|Reported Event|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237737|NCT00128193|E11|Reported Event|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237738|NCT00128193|E10|Reported Event|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
1237739|NCT00128193|E9|Reported Event|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
1237740|NCT00128193|E8|Reported Event|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237741|NCT00128193|E7|Reported Event|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237742|NCT00128193|E6|Reported Event|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237743|NCT00128193|E5|Reported Event|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
1237744|NCT00128193|E4|Reported Event|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237745|NCT00128193|E3|Reported Event|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237746|NCT00128193|E2|Reported Event|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
1237747|NCT00128193|E1|Reported Event|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
1237748|NCT00128180|B3|Baseline|Total|Total of all reporting groups
1237749|NCT00128180|B2|Baseline|Placebo|Placebo group
1237750|NCT00128180|B1|Baseline|Active|Active drug
1237751|NCT00128180|P2|Participant Flow|Placebo|Placebo group
1237752|NCT00128180|P1|Participant Flow|Active|Active drug
1237753|NCT00128180|O2|Outcome|Placebo|Placebo group
1237754|NCT00128180|O1|Outcome|Active|Active drug
1237755|NCT00128180|O2|Outcome|Placebo|Placebo group
1237756|NCT00128180|O1|Outcome|Active|Active drug
1237757|NCT00128180|O2|Outcome|Placebo|Placebo group
1237758|NCT00128180|O1|Outcome|Active|Active drug
1237759|NCT00128180|O2|Outcome|Placebo|Placebo group
1237760|NCT00128180|O1|Outcome|Active|Active drug
1237761|NCT00128180|O2|Outcome|Placebo|Placebo group
1237762|NCT00128180|O1|Outcome|Active|Active drug
1237763|NCT00128180|O2|Outcome|Placebo|Placebo group
1237764|NCT00128180|O1|Outcome|Active|Active drug
1237765|NCT00128180|O2|Outcome|Placebo|Placebo group
1237766|NCT00128180|O1|Outcome|Active|Active drug
1237767|NCT00128180|O2|Outcome|Placebo|Placebo group
1237768|NCT00128180|O1|Outcome|Active|Active drug
1237769|NCT00128180|O2|Outcome|Placebo|Placebo group
1237770|NCT00128180|O1|Outcome|Active|Active drug
1237771|NCT00128180|O2|Outcome|Placebo|Placebo group
1237772|NCT00128180|O1|Outcome|Active|Active drug
1237773|NCT00128180|E2|Reported Event|Placebo|Placebo group
1237774|NCT00128180|E1|Reported Event|Active|Active drug
1237775|NCT00127933|B3|Baseline|Total|Total of all reporting groups
1237880|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237776|NCT00127933|B2|Baseline|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly~HER2-neu positive: capecitabine + docetaxel + trastuzumab~Duration: Four 3-week treatment cycles"
1237777|NCT00127933|B1|Baseline|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1~HER2-neu negative: capecitabine + docetaxel~Duration: Four 3-week treatment cycles"
1237778|NCT00127933|P2|Participant Flow|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly~HER2-neu positive: capecitabine + docetaxel + trastuzumab~Duration: Four 3-week treatment cycles"
1237779|NCT00127933|P1|Participant Flow|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1~HER2-neu negative: capecitabine + docetaxel~Duration: Four 3-week treatment cycles"
1237780|NCT00127933|O2|Outcome|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly~HER2-neu positive: capecitabine + docetaxel + trastuzumab~Duration: Four 3-week treatment cycles"
1237781|NCT00127933|O1|Outcome|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1~HER2-neu negative: capecitabine + docetaxel~Duration: Four 3-week treatment cycles"
1237782|NCT00127933|O2|Outcome|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly~HER2-neu positive: capecitabine + docetaxel + trastuzumab~Duration: Four 3-week treatment cycles"
1237783|NCT00127933|O1|Outcome|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1~HER2-neu negative: capecitabine + docetaxel~Duration: Four 3-week treatment cycles"
1237784|NCT00127933|O2|Outcome|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly~HER2-neu positive: capecitabine + docetaxel + trastuzumab~Duration: Four 3-week treatment cycles"
1237785|NCT00127933|O1|Outcome|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1~HER2-neu negative: capecitabine + docetaxel~Duration: Four 3-week treatment cycles"
1237786|NCT00127933|O2|Outcome|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly~HER2-neu positive: capecitabine + docetaxel + trastuzumab~Duration: Four 3-week treatment cycles"
1237787|NCT00127933|O1|Outcome|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1~HER2-neu negative: capecitabine + docetaxel~Duration: Four 3-week treatment cycles"
1237788|NCT00127933|O2|Outcome|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly~HER2-neu positive: capecitabine + docetaxel + trastuzumab~Duration: Four 3-week treatment cycles"
1238023|NCT00127803|E1|Reported Event|Placebo Group|Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
1237789|NCT00127933|O1|Outcome|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1~HER2-neu negative: capecitabine + docetaxel~Duration: Four 3-week treatment cycles"
1237790|NCT00127933|O2|Outcome|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly~HER2-neu positive: capecitabine + docetaxel + trastuzumab~Duration: Four 3-week treatment cycles"
1237791|NCT00127933|O1|Outcome|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1~HER2-neu negative: capecitabine + docetaxel~Duration: Four 3-week treatment cycles"
1237792|NCT00127933|E2|Reported Event|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly~HER2-neu positive: capecitabine + docetaxel + trastuzumab~Duration: Four 3-week treatment cycles"
1237793|NCT00127933|E1|Reported Event|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1~HER2-neu negative: capecitabine + docetaxel~Duration: Four 3-week treatment cycles"
1237794|NCT00127855|B6|Baseline|Total|Total of all reporting groups
1237795|NCT00127855|B5|Baseline|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237796|NCT00127855|B4|Baseline|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237797|NCT00127855|B3|Baseline|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1238071|NCT00127530|P2|Participant Flow|Fampridine-SR|10 milligram (mg) tablet twice a day (b.i.d.)
1238072|NCT00127530|P1|Participant Flow|Placebo- Sugar Pill|Placebo control group
1237798|NCT00127855|B2|Baseline|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237799|NCT00127855|B1|Baseline|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237800|NCT00127855|P5|Participant Flow|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237801|NCT00127855|P4|Participant Flow|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237802|NCT00127855|P3|Participant Flow|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237803|NCT00127855|P2|Participant Flow|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237804|NCT00127855|P1|Participant Flow|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237805|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237806|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237807|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237808|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237809|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237810|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1238024|NCT00127790|B5|Baseline|Total|Total of all reporting groups
1237811|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237812|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237813|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237814|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237815|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237816|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237817|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1238031|NCT00127790|P2|Participant Flow|Cognitive-Behavioral Therapy for Pain (CBT-P)|Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
1237818|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237819|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237820|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237821|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237822|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237823|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237824|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237825|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237826|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237827|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237828|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237829|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237830|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237831|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1238557|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
1237832|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237833|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237834|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237835|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237836|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237837|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1238073|NCT00127530|O2|Outcome|Fampridine-SR|10 milligram (mg) tablet twice a day (b.i.d.)
1238074|NCT00127530|O1|Outcome|Placebo- Sugar Pill|Placebo control group
1238075|NCT00127530|E2|Reported Event|Fampridine-SR|10 milligram (mg) tablet twice a day (b.i.d.)
1237838|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237839|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237840|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237841|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237842|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237843|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237844|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237845|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237846|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237847|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237848|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237849|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237850|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237851|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237852|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1250590|NCT00092495|O3|Outcome|Women 16-23 Years|
1237853|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237854|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237855|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237856|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237857|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237858|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237859|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237860|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237861|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237862|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237863|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237864|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237865|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237866|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237867|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237868|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237869|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237870|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237871|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237872|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237873|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1250591|NCT00092495|O2|Outcome|Boys 10-15 Years|
1237874|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237875|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237876|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237877|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237878|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237879|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237881|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237882|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237883|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237884|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237885|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237886|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237887|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237888|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237889|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237890|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237891|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237892|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237893|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237894|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1250592|NCT00092495|O1|Outcome|Girls 10-15 Years|
1237895|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237896|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237897|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237898|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237899|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237900|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237901|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237902|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237903|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237904|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237905|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237906|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237907|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237908|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237909|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237910|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237911|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237912|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237913|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237914|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237915|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1239274|NCT00123162|O1|Outcome|Sildenafil Citrate|A single vaginal dose of sildenafil citrate 100 mg.
1237916|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237917|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237918|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237919|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237920|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237921|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1238076|NCT00127530|E1|Reported Event|Placebo- Sugar Pill|Placebo control group
1238077|NCT00127413|B5|Baseline|Total|Total of all reporting groups
1238078|NCT00127413|B4|Baseline|Treat as Usual|Participants received care for pain and PTSD as usual from their primary care provider.
1237922|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237923|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237924|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237925|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237926|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237927|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237928|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237929|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237930|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237931|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237932|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237933|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237934|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237935|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237936|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1239275|NCT00123162|E2|Reported Event|Placebo|A single vaginal dose of placebo.
1237937|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237938|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237939|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237940|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237941|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237942|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237943|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237944|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237945|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237946|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237947|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237948|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237949|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237950|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237951|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237952|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237953|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237954|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237955|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237956|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237957|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1250839|NCT00091273|E1|Reported Event|Single Arm|
1237958|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237959|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237960|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237961|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237962|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237963|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237964|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237965|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237966|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237967|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237968|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237969|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237970|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237971|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237972|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237973|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237974|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237975|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237976|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237977|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237978|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1251139|NCT00090259|E1|Reported Event|Losartan 50 mg|
1237979|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237980|NCT00127855|E5|Reported Event|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237981|NCT00127855|E4|Reported Event|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237982|NCT00127855|E3|Reported Event|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237983|NCT00127855|E2|Reported Event|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1238032|NCT00127790|P1|Participant Flow|Cognitive-Behavioral Therapy for Insomnia (CBT-I)|Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
1237984|NCT00127855|E1|Reported Event|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
1237985|NCT00127842|B1|Baseline|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
1237986|NCT00127842|P1|Participant Flow|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
1237987|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
1237988|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
1237989|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
1237990|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
1237991|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
1237992|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
1237993|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
1237994|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
1237995|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
1237996|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
1237997|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
1237998|NCT00127842|E1|Reported Event|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
1237999|NCT00127803|B5|Baseline|Total|Total of all reporting groups
1238000|NCT00127803|B4|Baseline|High Dose Vaccine Group|Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
1238001|NCT00127803|B3|Baseline|Medium Dose Vaccine Group|Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
1238002|NCT00127803|B2|Baseline|Low Dose Vaccine Group|Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
1238003|NCT00127803|B1|Baseline|Placebo Group|Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
1238004|NCT00127803|P4|Participant Flow|High Dose Vaccine Group|Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
1238005|NCT00127803|P3|Participant Flow|Medium Dose Vaccine Group|Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
1238006|NCT00127803|P2|Participant Flow|Low Dose Vaccine Group|Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
1238007|NCT00127803|P1|Participant Flow|Placebo Group|Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
1238008|NCT00127803|O4|Outcome|High Dose Vaccine Group|Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
1238009|NCT00127803|O3|Outcome|Medium Dose Vaccine Group|Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
1238010|NCT00127803|O2|Outcome|Low Dose Vaccine Group|Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
1238011|NCT00127803|O1|Outcome|Placebo Group|Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
1238012|NCT00127803|O4|Outcome|High Dose Vaccine Group|Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
1238013|NCT00127803|O3|Outcome|Medium Dose Vaccine Group|Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
1238014|NCT00127803|O2|Outcome|Low Dose Vaccine Group|Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
1238015|NCT00127803|O1|Outcome|Placebo Group|Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
1238016|NCT00127803|O4|Outcome|High Dose Vaccine Group|Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
1238017|NCT00127803|O3|Outcome|Medium Dose Vaccine Group|Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
1251140|NCT00090233|B3|Baseline|Total|Total of all reporting groups
1238026|NCT00127790|B3|Baseline|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
1238027|NCT00127790|B2|Baseline|Cognitive-Behavioral Therapy for Pain (CBT-P)|Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
1238028|NCT00127790|B1|Baseline|Cognitive-Behavioral Therapy for Insomnia (CBT-I)|Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
1238029|NCT00127790|P4|Participant Flow|Wait-List Control (WL)|Waitlist Control condition (WL) with no contact during the intervention period.
1238030|NCT00127790|P3|Participant Flow|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
1238033|NCT00127790|O4|Outcome|Wait-List Control (WL)|Waitlist Control condition (WL) with no contact during the intervention period.
1238034|NCT00127790|O3|Outcome|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
1238035|NCT00127790|O2|Outcome|Cognitive-Behavioral Therapy for Pain (CBT-P)|Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
1238036|NCT00127790|O1|Outcome|Cognitive-Behavioral Therapy for Insomnia (CBT-I)|Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
1238037|NCT00127790|O4|Outcome|Wait-List Control (WL)|Waitlist Control condition (WL) with no contact during the intervention period.
1238038|NCT00127790|O3|Outcome|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
1238039|NCT00127790|O2|Outcome|Cognitive-Behavioral Therapy for Pain (CBT-P)|Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
1238040|NCT00127790|O1|Outcome|Cognitive-Behavioral Therapy for Insomnia (CBT-I)|Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
1238041|NCT00127790|O4|Outcome|Wait-List Control (WL)|Waitlist Control condition (WL) with no contact during the intervention period.
1238042|NCT00127790|O3|Outcome|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
1238043|NCT00127790|O2|Outcome|Cognitive-Behavioral Therapy for Pain (CBT-P)|Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
1238044|NCT00127790|O1|Outcome|Cognitive-Behavioral Therapy for Insomnia (CBT-I)|Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
1238045|NCT00127790|O4|Outcome|Wait-List Control (WL)|Waitlist Control condition (WL) with no contact during the intervention period.
1238046|NCT00127790|O3|Outcome|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
1238047|NCT00127790|O2|Outcome|Cognitive-Behavioral Therapy for Pain (CBT-P)|Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
1238048|NCT00127790|O1|Outcome|Cognitive-Behavioral Therapy for Insomnia (CBT-I)|Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
1238049|NCT00127790|E4|Reported Event|Wait-List Control (WL)|Waitlist Control condition (WL) with no contact during the intervention period.
1238100|NCT00127218|O1|Outcome|Niacin Plus Statin|Extended release niacin (1500 mg daily) plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
1238050|NCT00127790|E3|Reported Event|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
1238051|NCT00127790|E2|Reported Event|Cognitive-Behavioral Therapy for Pain (CBT-P)|Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
1238052|NCT00127790|E1|Reported Event|Cognitive-Behavioral Therapy for Insomnia (CBT-I)|Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
1238053|NCT00127712|B3|Baseline|Total|Total of all reporting groups
1238054|NCT00127712|B2|Baseline|Control|Control group
1238055|NCT00127712|B1|Baseline|Amiodarone|Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
1238056|NCT00127712|P2|Participant Flow|Control|Control group
1238057|NCT00127712|P1|Participant Flow|Amiodarone|Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
1238058|NCT00127712|O2|Outcome|Control|Control group
1238059|NCT00127712|O1|Outcome|Amiodarone|Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
1238060|NCT00127712|O2|Outcome|Control|Control group
1238061|NCT00127712|O1|Outcome|Amiodarone|Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
1238062|NCT00127712|O2|Outcome|Control|Control group
1238063|NCT00127712|O1|Outcome|Amiodarone|Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
1238064|NCT00127712|O2|Outcome|Control|Control group
1238081|NCT00127413|B1|Baseline|Cognitive Behavioral Therapy - Pain|Cognitive Behavioral Therapy targeting chronic pain
1238082|NCT00127413|P4|Participant Flow|Treat as Usual|Participants received care for pain and PTSD as usual from their primary care provider.
1238083|NCT00127413|P3|Participant Flow|Cognitive Behavioral Therapy - Integrated|Integrated treatment for comorbid chronic pain and PTSD
1238084|NCT00127413|P2|Participant Flow|Cognitive Processing Therapy - PTSD|Cognitive processing therapy for PTSD
1238085|NCT00127413|P1|Participant Flow|Cognitive Behavioral Therapy - Pain|Cognitive Behavioral Therapy targeting chronic pain
1238086|NCT00127413|O4|Outcome|Treat as Usual|Participants received care for pain and PTSD as usual from their primary care provider
1238087|NCT00127413|O3|Outcome|Cognitive Behavioral Therapy - Integrated|Cognitive Behavioral Therapy - Integrated treatment for pain and PTSD
1238088|NCT00127413|O2|Outcome|Cognitive Processing Therapy - PTSD|Cognitive processing therapy for PTSD
1238089|NCT00127413|O1|Outcome|Cognitive Behavioral Therapy - Pain|Cognitive Behavioral Therapy targeting chronic pain
1238090|NCT00127413|E4|Reported Event|Treat as Usual|Participants received care for pain and PTSD as usual from their primary care provider.
1238091|NCT00127413|E3|Reported Event|Cognitive Behavioral Therapy-Integrated|Integrated treatment for comorbid chronic pain and PTSD
1238092|NCT00127413|E2|Reported Event|Cognitive Processing Therapy - PTSD|Cognitive processing therapy for PTSD
1238093|NCT00127413|E1|Reported Event|Cognitive Behavioral Therapy - Pain|Cognitive Behavioral Therapy targeting chronic pain
1238094|NCT00127218|B3|Baseline|Total|Total of all reporting groups
1238095|NCT00127218|B2|Baseline|Placebo Plus Statin|placebo plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
1238096|NCT00127218|B1|Baseline|Niacin Plus Statin|Extended release niacin (1500 mg daily) plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
1238097|NCT00127218|P2|Participant Flow|Placebo Plus Statin|placebo plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
1238098|NCT00127218|P1|Participant Flow|Niacin Plus Statin|Extended release niacin (1500 mg daily) plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
1238099|NCT00127218|O2|Outcome|Placebo Plus Statin|placebo plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
1238174|NCT00127101|O2|Outcome|Cohort 2|Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
1238101|NCT00127218|E2|Reported Event|Placebo Plus Statin|placebo plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
1238102|NCT00127218|E1|Reported Event|Niacin Plus Statin|Extended release niacin (1500 mg daily) plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
1238103|NCT00127192|B6|Baseline|Total|Total of all reporting groups
1238104|NCT00127192|B5|Baseline|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
1238105|NCT00127192|B4|Baseline|Sitagliptin 200 mg QD|The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
1238106|NCT00127192|B3|Baseline|Sitagliptin 100 mg QD|The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
1238107|NCT00127192|B2|Baseline|Sitagliptin 50 mg QD|The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
1238108|NCT00127192|B1|Baseline|Sitagliptin 25 mg QD|The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
1238109|NCT00127192|P5|Participant Flow|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
1238110|NCT00127192|P4|Participant Flow|Sitagliptin 200 mg QD|The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
1238111|NCT00127192|P3|Participant Flow|Sitagliptin 100 mg QD|The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
1238112|NCT00127192|P2|Participant Flow|Sitagliptin 50 mg QD|The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
1238113|NCT00127192|P1|Participant Flow|Sitagliptin 25 mg QD|The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
1238114|NCT00127192|O5|Outcome|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
1238115|NCT00127192|O4|Outcome|Sitagliptin 200 mg QD|The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
1238116|NCT00127192|O3|Outcome|Sitagliptin 100 mg QD|The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
1238117|NCT00127192|O2|Outcome|Sitagliptin 50 mg QD|The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
1238118|NCT00127192|O1|Outcome|Sitagliptin 25 mg QD|The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
1238119|NCT00127192|O5|Outcome|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
1238120|NCT00127192|O4|Outcome|Sitagliptin 200 mg QD|The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
1238121|NCT00127192|O3|Outcome|Sitagliptin 100 mg QD|The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
1238122|NCT00127192|O2|Outcome|Sitagliptin 50 mg QD|The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
1238123|NCT00127192|O1|Outcome|Sitagliptin 25 mg QD|The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
1238124|NCT00127192|O5|Outcome|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
1238125|NCT00127192|O4|Outcome|Sitagliptin 200 mg QD|The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
1238126|NCT00127192|O3|Outcome|Sitagliptin 100 mg QD|The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
1238127|NCT00127192|O2|Outcome|Sitagliptin 50 mg QD|The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
1238128|NCT00127192|O1|Outcome|Sitagliptin 25 mg QD|The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
1238129|NCT00127192|E5|Reported Event|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
1238130|NCT00127192|E4|Reported Event|Sitagliptin 200 mg QD|The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
1238131|NCT00127192|E3|Reported Event|Sitagliptin 100 mg QD|The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
1238132|NCT00127192|E2|Reported Event|Sitagliptin 50 mg QD|The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
1238133|NCT00127192|E1|Reported Event|Sitagliptin 25 mg QD|The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
1238134|NCT00127166|B3|Baseline|Total|Total of all reporting groups
1238135|NCT00127166|B2|Baseline|Salmeterol / Montelukast|Period I- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
1240281|NCT00120406|O1|Outcome|Zilver PTX|Zilver® PTX™ Drug Eluting Vascular Stent
1238136|NCT00127166|B1|Baseline|Montelukast / Salmeterol|Period I- Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
1238137|NCT00127166|P2|Participant Flow|Salmeterol / Montelukast|Period I- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
1238138|NCT00127166|P1|Participant Flow|Montelukast / Salmeterol|Period I- Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
1238139|NCT00127166|O2|Outcome|Salmeterol|Salmeterol DPI 50 mcg twice daily, inhaled Fluticasone 100 mcg twice daily.
1238140|NCT00127166|O1|Outcome|Montelukast|Montelukast 5 mg oral tablet once daily, inhaled Fluticasone 100 mcg twice daily.
1238141|NCT00127166|O2|Outcome|Salmeterol|Salmeterol DPI 50 mcg twice daily, inhaled Fluticasone 100 mcg twice daily.
1238142|NCT00127166|O1|Outcome|Montelukast|Montelukast 5 mg oral tablet once daily, inhaled Fluticasone 100 mcg twice daily.
1238143|NCT00127166|O2|Outcome|Salmeterol|Salmeterol DPI 50 mcg twice daily, inhaled Fluticasone 100 mcg twice daily.
1238144|NCT00127166|O1|Outcome|Montelukast|Montelukast 5 mg oral tablet once daily, inhaled Fluticasone 100 mcg twice daily.
1238145|NCT00127166|O2|Outcome|Salmeterol|Salmeterol DPI 50 mcg twice daily, inhaled Fluticasone 100 mcg twice daily.
1238146|NCT00127166|O1|Outcome|Montelukast|Montelukast 5 mg oral tablet once daily, inhaled Fluticasone 100 mcg twice daily.
1238147|NCT00127166|O2|Outcome|Salmeterol|Salmeterol DPI 50 mcg twice daily, inhaled Fluticasone 100 mcg twice daily.
1238148|NCT00127166|O1|Outcome|Montelukast|Montelukast 5 mg oral tablet once daily, inhaled Fluticasone 100 mcg twice daily.
1238149|NCT00127166|E2|Reported Event|Salmeterol|"Period I- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks.~Period II- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks.~Inhaled Fluticasone 100 mcg twice daily throughout the study."
1238150|NCT00127166|E1|Reported Event|Montelukast|"Period I- Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks.~Period II- Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks.~Inhaled Fluticasone 100 mcg twice daily throughout the study."
1238151|NCT00127101|B7|Baseline|Total|Total of all reporting groups
1238152|NCT00127101|B6|Baseline|Cohort 7|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week [150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)]
1238153|NCT00127101|B5|Baseline|Cohort 6|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
1238154|NCT00127101|B4|Baseline|Cohort 2b|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter[2] daily x 7 days per week
1238155|NCT00127101|B3|Baseline|Cohort 2a|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter[2] daily x 7 days per week
1238156|NCT00127101|B2|Baseline|Cohort 2|Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
1238157|NCT00127101|B1|Baseline|Cohort 1|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
1238158|NCT00127101|P6|Participant Flow|Cohort 7|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week [150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)]
1238159|NCT00127101|P5|Participant Flow|Cohort 6|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
1238160|NCT00127101|P4|Participant Flow|Cohort 2b|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter[2] daily x 7 days per week
1238161|NCT00127101|P3|Participant Flow|Cohort 2a|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter[2] daily x 7 days per week
1238162|NCT00127101|P2|Participant Flow|Cohort 2|Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
1238163|NCT00127101|P1|Participant Flow|Cohort 1|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
1238164|NCT00127101|O6|Outcome|Cohort 7|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week [150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)]
1238165|NCT00127101|O5|Outcome|Cohort 6|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
1238166|NCT00127101|O4|Outcome|Cohort 2b|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter[2] daily x 7 days per week
1238167|NCT00127101|O3|Outcome|Cohort 2a|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter[2] daily x 7 days per week
1238168|NCT00127101|O2|Outcome|Cohort 2|Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
1238169|NCT00127101|O1|Outcome|Cohort 1|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
1238170|NCT00127101|O6|Outcome|Cohort 7|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week [150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)]
1238171|NCT00127101|O5|Outcome|Cohort 6|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
1238172|NCT00127101|O4|Outcome|Cohort 2b|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter[2] daily x 7 days per week
1238173|NCT00127101|O3|Outcome|Cohort 2a|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter[2] daily x 7 days per week
1251570|NCT00089661|O1|Outcome|Denosumab 60 mg Q6M|
1238175|NCT00127101|O1|Outcome|Cohort 1|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
1238176|NCT00127101|E6|Reported Event|Cohort 7|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week [150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)]
1238177|NCT00127101|E5|Reported Event|Cohort 6|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
1238178|NCT00127101|E4|Reported Event|Cohort 2b|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter[2] daily x 7 days per week
1238179|NCT00127101|E3|Reported Event|Cohort 2a|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter[2] daily x 7 days per week
1238180|NCT00127101|E2|Reported Event|Cohort 2|Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
1238181|NCT00127101|E1|Reported Event|Cohort 1|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
1238182|NCT00127036|B3|Baseline|Total|Total of all reporting groups
1238183|NCT00127036|B2|Baseline|XELIRI + Bevacizumab|Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
1238184|NCT00127036|B1|Baseline|XELOX + Bevacizumab|Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
1238185|NCT00127036|P2|Participant Flow|XELIRI + Bevacizumab|Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
1238186|NCT00127036|P1|Participant Flow|XELOX + Bevacizumab|Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
1238187|NCT00127036|O2|Outcome|XELIRI + Bevacizumab|Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
1238188|NCT00127036|O1|Outcome|XELOX + Bevacizumab|Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
1238189|NCT00127036|O2|Outcome|XELIRI + Bevacizumab|Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
1238190|NCT00127036|O1|Outcome|XELOX + Bevacizumab|Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
1238191|NCT00127036|O2|Outcome|XELIRI + Bevacizumab|Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
1238192|NCT00127036|O1|Outcome|XELOX + Bevacizumab|Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
1238193|NCT00127036|E2|Reported Event|XELIRI + Bevacizumab|Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
1238194|NCT00127036|E1|Reported Event|XELOX + Bevacizumab|Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
1238201|NCT00126776|O1|Outcome|Disease Management for COPD|disease management for COPD
1238202|NCT00126750|B3|Baseline|Total|Total of all reporting groups
1238203|NCT00126750|B2|Baseline|Control Arm/Group|Providers from eligible clinics that were allocated to the control arm.
1238204|NCT00126750|B1|Baseline|Intervention Arm/Group|Providers from eligible clinics that were allocated to the intervention arm.
1238205|NCT00126750|P2|Participant Flow|Control Group|Providers in control clinics were sent a link to an existing VA Web site that contained links to a wide range of clinical guidelines for various medical conditions.
1238206|NCT00126750|P1|Participant Flow|Intervention Group|The intervention included a multicomponent Web site and pushed e-mail cues with educational content.
1238207|NCT00126750|O2|Outcome|Control|Control Providers received a link to VA practice guidelines.
1238208|NCT00126750|O1|Outcome|Intervention|Intervention Providers received an interactive, educational website and motivational reminders.
1238209|NCT00126750|E2|Reported Event|Control Group|Because this was an RCT of clinics and providers utilization of web-based intervention, no serious (or non-serious) adverse events were collected.
1238210|NCT00126750|E1|Reported Event|Intervention Group|Because this was an RCT of clinics and providers utilization of web-based intervention, no serious (or non-serious) adverse events were collected.
1238211|NCT00126737|B5|Baseline|Total|Total of all reporting groups
1238212|NCT00126737|B4|Baseline|Usual Care|Usual care and non-specific health information (C). No intervention.
1238213|NCT00126737|B3|Baseline|Home-based Exercise Program|"Group assigned to a Home-based exercise program (Ex).~Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
1238214|NCT00126737|B2|Baseline|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
1238241|NCT00126737|E3|Reported Event|Home-based Exercise Program|"Group assigned to a Home-based exercise program (Ex).~Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
1251571|NCT00089661|O2|Outcome|Placebo|
1238215|NCT00126737|B1|Baseline|Weight Control Nutritional and Home-based Exercise Pro|"Group assigned to both a Weight Control Nutritional Program and home-based exercise Program (Ex+WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
1238216|NCT00126737|P4|Participant Flow|Usual Care|Usual care and non-specific health information (C). No intervention.
1238217|NCT00126737|P3|Participant Flow|Home-based Exercise Program|"Group assigned to a home-based exercise program (Ex).~Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
1238218|NCT00126737|P2|Participant Flow|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
1238219|NCT00126737|P1|Participant Flow|Weight Control Nutritional and Home-based Exercise Program|"Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises"
1238220|NCT00126737|O4|Outcome|Usual Care|Usual Care and non-specific health information (C). No intervention.
1238221|NCT00126737|O3|Outcome|Home-based Exercise Program|"Group assigned to a Home-based exercise program (Ex).~Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
1238222|NCT00126737|O2|Outcome|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
1238223|NCT00126737|O1|Outcome|Weight Control Nutritional and Home-based Exercise Pro|"Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
1238224|NCT00126737|O4|Outcome|Usual Care|Usual Care and non-specific health information (C). No intervention.
1238225|NCT00126737|O3|Outcome|Home-based Exercise Program|"Group assigned to a Home-based exercise program (Ex).~Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
1238226|NCT00126737|O2|Outcome|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
1238227|NCT00126737|O1|Outcome|Weight Control Nutritional and Home-based Exercise Pro|"Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
1238228|NCT00126737|O4|Outcome|Usual Care|Usual Care and non-specific health information (C). No intervention.
1238229|NCT00126737|O3|Outcome|Home-based Exercise Program|"Group assigned to a Home-based exercise program (Ex).~Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
1238230|NCT00126737|O2|Outcome|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
1238264|NCT00126594|O1|Outcome|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
1238405|NCT00125931|B1|Baseline|Open Label|Open label treatment with pentazocine
1238231|NCT00126737|O1|Outcome|Weight Control Nutritional and Home-based Exercise pr|"Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
1238232|NCT00126737|O4|Outcome|Usual Care|Usual Care and non-specific health information (C). No intervention.
1238233|NCT00126737|O3|Outcome|Home-based Exercise Program|"Group assigned to a Home-based exercise program (Ex).~Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
1238234|NCT00126737|O2|Outcome|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
1238235|NCT00126737|O1|Outcome|Weight Control Nutritional and Home-based Exercise Pro|"Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
1238236|NCT00126737|O4|Outcome|Usual Care|Usual care and non-specific health information (C). No intervention.
1238237|NCT00126737|O3|Outcome|Home-based Exercise Program|"Group assigned to a home-based exercise program (Ex).~Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
1238238|NCT00126737|O2|Outcome|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
1238239|NCT00126737|O1|Outcome|Weight Control Nutritional and Home-based Exercise Pro|"Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
1238240|NCT00126737|E4|Reported Event|Usual Care|Usual Care and non-specific health information (C). No intervention.
1238242|NCT00126737|E2|Reported Event|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
1238243|NCT00126737|E1|Reported Event|Weight Control Nutritional and Home-based Exercise Pro|"Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
1238244|NCT00126659|B4|Baseline|Total|Total of all reporting groups
1238245|NCT00126659|B3|Baseline|Sorafenib + Cytoreductive Nephrectomy Day 29|Group 3: Four weeks Sorafenib 400 mg orally mouth twice a day, Cytoreductive Nephrectomy, two weeks rest, 6 weeks Sorafenib
1238246|NCT00126659|B2|Baseline|Sorafenib + Cytoreductive Nephrectomy Day 8|Group 2: One week Sorafenib 400 mg orally mouth twice a day, cytoreductive nephrectomy, two weeks rest, 9 weeks Sorafenib
1238247|NCT00126659|B1|Baseline|Cytoreductive Nephrectomy Day 0|Group 1: Immediate cytoreductive nephrectomy, two weeks rest, and 10 weeks Sorafenib 400 mg orally mouth twice a day.
1238248|NCT00126659|P3|Participant Flow|Sorafenib + Cytoreductive Nephrectomy Day 29|Group 3: Four weeks Sorafenib 400 mg orally mouth twice a day, Cytoreductive Nephrectomy, two weeks rest, 6 weeks Sorafenib
1238249|NCT00126659|P2|Participant Flow|Sorafenib + Cytoreductive Nephrectomy Day 8|Group 2: One week Sorafenib 400 mg orally mouth twice a day, cytoreductive nephrectomy, two weeks rest, 9 weeks Sorafenib
1238250|NCT00126659|P1|Participant Flow|Cytoreductive Nephrectomy Day 0|Group 1: Immediate cytoreductive nephrectomy, two weeks rest, and 10 weeks Sorafenib 400 mg orally mouth twice a day.
1238251|NCT00126659|O3|Outcome|Sorafenib + Cytoreductive Nephrectomy Day 29|Group 3: Four weeks Sorafenib 400 mg orally mouth twice a day, Cytoreductive Nephrectomy, two weeks rest, 6 weeks Sorafenib
1238252|NCT00126659|O2|Outcome|Sorafenib + Cytoreductive Nephrectomy Day 8|Group 2: One week Sorafenib 400 mg orally mouth twice a day, cytoreductive nephrectomy, two weeks rest, 9 weeks Sorafenib
1238253|NCT00126659|O1|Outcome|Cytoreductive Nephrectomy Day 0|Group 1: Immediate cytoreductive nephrectomy, two weeks rest, and 10 weeks Sorafenib 400 mg orally mouth twice a day.
1238254|NCT00126659|E1|Reported Event|Sorafenib + Cytoreductive Nephrectomy|All participants received Sorafenib 400 mg orally mouth twice a day for a total of 10 weeks over the course of the study and had surgical procedure Cytoreductive Nephrectomy before treatment with Sorafenib or in between courses of Sorafenib
1238255|NCT00126594|B3|Baseline|Total|Total of all reporting groups
1238256|NCT00126594|B2|Baseline|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
1238257|NCT00126594|B1|Baseline|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
1238258|NCT00126594|P2|Participant Flow|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
1238259|NCT00126594|P1|Participant Flow|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
1238260|NCT00126594|O2|Outcome|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
1238261|NCT00126594|O1|Outcome|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
1238262|NCT00126594|O1|Outcome|Sorafenib Tosylate or Sorafenib Plus Interferon|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28 and Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
1238263|NCT00126594|O2|Outcome|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
1238265|NCT00126594|O2|Outcome|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
1238266|NCT00126594|O1|Outcome|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
1238267|NCT00126594|O2|Outcome|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
1238268|NCT00126594|O1|Outcome|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
1238269|NCT00126594|O2|Outcome|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
1238270|NCT00126594|O1|Outcome|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
1238271|NCT00126594|E2|Reported Event|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
1238272|NCT00126594|E1|Reported Event|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
1238273|NCT00126581|B3|Baseline|Total|Total of all reporting groups
1238274|NCT00126581|B2|Baseline|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
1238275|NCT00126581|B1|Baseline|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1238276|NCT00126581|P2|Participant Flow|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
1238277|NCT00126581|P1|Participant Flow|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1238278|NCT00126581|O2|Outcome|Wild Type|
1238282|NCT00126581|O2|Outcome|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
1238283|NCT00126581|O1|Outcome|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1238284|NCT00126581|O2|Outcome|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
1238285|NCT00126581|O1|Outcome|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1238286|NCT00126581|O2|Outcome|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
1238287|NCT00126581|O1|Outcome|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1238288|NCT00126581|O2|Outcome|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
1238289|NCT00126581|O1|Outcome|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1238290|NCT00126581|O2|Outcome|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
1238291|NCT00126581|O1|Outcome|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1238292|NCT00126581|O2|Outcome|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
1238293|NCT00126581|O1|Outcome|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1238294|NCT00126581|E2|Reported Event|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
1238295|NCT00126581|E1|Reported Event|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1238296|NCT00126568|B1|Baseline|BAY 43-9006|BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
1238297|NCT00126568|P1|Participant Flow|BAY 43-9006|BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
1238298|NCT00126568|O1|Outcome|BAY 43-9006|BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
1238299|NCT00126568|O1|Outcome|BAY 43-9006|BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
1238300|NCT00126568|O1|Outcome|BAY 43-9006|BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
1238301|NCT00126568|E1|Reported Event|BAY 43-9006|BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
1238302|NCT00126555|B1|Baseline|Gefitinib, Radiotherapy, Surgery|Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase.
1238303|NCT00126555|P1|Participant Flow|Gefitinib, Radiotherapy, Surgery|Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase.
1238304|NCT00126555|O4|Outcome|Maintenance Phase|Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase (Gefitinib Induction dose 250 mg/day or 500 mg/day dose escalation).
1238343|NCT00126438|P1|Participant Flow|AdreView - Heart Failure Group|AdreView (123I-mIBG [meta-iodobenzylguanidine]): 10 milliCurie (mCi) as a single intravenous dose.
1238305|NCT00126555|O3|Outcome|Radiation With Gefitinib|Participants received Radiation with Gefitinib therapy following evaluation for clinical response and resectability at Induction (with or without dose doubling): Resectable strata who achieved at least stable disease received surgery followed by radiation treatment and 12 additional months of Gefitinib post radiation; and the Unresectable strata who achieved at least stable disease received concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated).
1238306|NCT00126555|O2|Outcome|Induction Phase With Dose Escalation|Participants received Gefitinib Induction therapy daily for 2 months then were evaluated for clinical response and resectability: Gefitinib starting dose 250 mg/day with doubling to 500 mg/day for no response Day 15.
1238307|NCT00126555|O1|Outcome|Induction Phase|Participants received Gefitinib Induction therapy daily for 2 months then were evaluated for clinical response and resectability: Gefitinib Induction Phase dose 250 mg/day with no doubling for no response at Day 15.
1238308|NCT00126555|O1|Outcome|Gefitinib, Radiotherapy, Surgery|Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase.
1238309|NCT00126555|O1|Outcome|Gefitinib, Radiotherapy, Surgery|"Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase.~Gefitinib Induction Phase starting dose 250 mg/day, possible doubling to 500 mg/day for no response Day 15; Maintenance dose post radiation starts at same dose level as last dosing of Induction Phase."
1238310|NCT00126555|O4|Outcome|Maintenance|Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase (Gefitinib Induction dose 250 mg/day or 500 mg/day dose escalation).
1238311|NCT00126555|O3|Outcome|Radiation With Gefitinib|Participants received Radiation with Gefitinib therapy following evaluation for clinical response and resectability at Induction (with or without dose doubling): Resectable strata who achieved at least stable disease received surgery followed by radiation treatment and 12 additional months of Gefitinib post radiation; and the Unresectable strata who achieved at least stable disease received concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated).
1238312|NCT00126555|O2|Outcome|Induction With Dose Escalation|Participants received Gefitinib Induction therapy daily for 2 months then were evaluated for clinical response and resectability: Gefitinib starting dose 250 mg/day with doubling to 500 mg/day for no response Day 15.
1238313|NCT00126555|O1|Outcome|Induction Phase|Participants received Gefitinib Induction therapy daily for 2 months then were evaluated for clinical response and resectability: Gefitinib Induction Phase dose 250 mg/day with no doubling for no response at Day 15.
1238314|NCT00126555|O1|Outcome|Gefitinib, Radiotherapy, Surgery|"Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase.~Gefitinib Induction Phase starting dose 250 mg/day, possible doubling to 500 mg/day for no response Day 15; Maintenance dose post radiation starts at same dose level as last dosing of Induction Phase."
1238315|NCT00126555|E1|Reported Event|Gefitinib, Radiotherapy, Surgery|"Resectable Strata: Induction Gefitinib (60 days), Surgery followed 3-6 weeks later by daily Radiotherapy 5 days a week for approximately 6-7 weeks then after 4 weeks restart Maintenance Gefitinib for up to additional 12 months post radiation.~Unresectable Strata: Concomitant Radiation/Gefitinib and post-radiation (or post-surgery if surgery is indicated) Gefitinib. Daily Radiotherapy 5 days a week for approximately 6-7 weeks concurrent with Maintenance Gefitinib dose daily up to 12 months.~Gefitinib Induction Phase starting dose 250 mg/day, possible doubling to 500 mg/day for no response Day 15; Maintenance dose post radiation starts at same dose level as last dosing of Induction Phase."
1238316|NCT00126503|B3|Baseline|Total|Total of all reporting groups
1238317|NCT00126503|B2|Baseline|Phase II|Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
1238318|NCT00126503|B1|Baseline|Phase I|Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3 day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
1238319|NCT00126503|P2|Participant Flow|Phase II|Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
1238320|NCT00126503|P1|Participant Flow|Phase I|Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3 day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
1238321|NCT00126503|O2|Outcome|Phase II|Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1. No Phase II patients were in the Phase I cohort.
1238322|NCT00126503|O1|Outcome|Phase I|The highest dose in milligrams (mg) of BAY 43-9006 (Sorafenib) in combination with Bevacizumab while maintaining tolerability. The highest dose in milligrams/kilograms of body weight mg/kg of Bevacizumab in combination with BAY 43-9006 (Sorafenib) while maintaining tolerability. No Phase I patients moved to the Phase II cohort.
1238323|NCT00126503|O1|Outcome|Phase I|Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3 day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
1238324|NCT00126503|O2|Outcome|Phase II|Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
1238325|NCT00126503|O1|Outcome|Phase I|The highest dose in milligrams (mg) of BAY 43-9006 (Sorafenib) in combination with Bevacizumab while maintaining tolerability. The highest dose in milligrams/kilograms of body weight mg/kg of Bevacizumab in combination with BAY 43-9006 (Sorafenib) while maintaining tolerability.
1238326|NCT00126503|O2|Outcome|Phase II|Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
1238327|NCT00126503|O1|Outcome|Phase I|The highest dose in milligrams (mg) of BAY 43-9006 (Sorafenib) in combination with Bevacizumab while maintaining tolerability. The highest dose in milligrams/kilograms of body weight mg/kg of Bevacizumab in combination with BAY 43-9006 (Sorafenib) while maintaining tolerability.
1238328|NCT00126503|O1|Outcome|Phase I|Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3-day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
1238329|NCT00126503|E2|Reported Event|Phase II|Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
1238330|NCT00126503|E1|Reported Event|Phase I|Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3 day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
1238331|NCT00126490|B1|Baseline|Treatment (Bevacizumab, Aldesleukin)|Patients receive bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also receive interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeats every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then receive bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
1238332|NCT00126490|P1|Participant Flow|Treatment (Bevacizumab, Aldesleukin)|Patients receive bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also receive interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeats every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then receive bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
1238333|NCT00126490|O1|Outcome|Treatment (Bevacizumab, Aldesleukin)|Patients received bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also received interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeated every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then received bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeated every 12 weeks in the absence of disease progression or unacceptable toxicity.
1238370|NCT00126126|B1|Baseline|Intervention|Those subjects who were randomized to receive the Evidence Based Amputee Rehabilitation (EBAR) Program
1238371|NCT00126126|P2|Participant Flow|Wait-List Control Group|These individuals waited 8 weeks in order to begin the intervention.
1238372|NCT00126126|P1|Participant Flow|Intervention|"Evidence Based Amputee Rehabilitation Program~Exercise: Evidence Based Amputee Rehabilitation Program"
1238334|NCT00126490|O1|Outcome|Treatment (Bevacizumab, Aldesleukin)|Patients received bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also received interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeated every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then received bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeated every 12 weeks in the absence of disease progression or unacceptable toxicity.
1238335|NCT00126490|O1|Outcome|Treatment (Bevacizumab, Aldesleukin)|Patients received bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also received interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeated every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then received bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeated every 12 weeks in the absence of disease progression or unacceptable toxicity.
1238336|NCT00126490|O1|Outcome|Treatment (Bevacizumab, Aldesleukin)|Patients received bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also received interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeated every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then received bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeated every 12 weeks in the absence of disease progression or unacceptable toxicity.
1238337|NCT00126490|O1|Outcome|Treatment (Bevacizumab, Aldesleukin)|Patients received bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also received interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeated every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then received bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeated every 12 weeks in the absence of disease progression or unacceptable toxicity.
1238338|NCT00126490|E1|Reported Event|Treatment (Bevacizumab, Aldesleukin)|Patients receive bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also receive interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeats every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then receive bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
1238339|NCT00126438|B3|Baseline|Total|Total of all reporting groups
1238340|NCT00126438|B2|Baseline|Adreview - Control Group|AdreView (123I-mIBG): 10 mCi as a single intravenous dose.
1238341|NCT00126438|B1|Baseline|AdreView - Heart Failure|AdreView (123I-mIBG): 10 mCi as a single intravenous dose.
1238342|NCT00126438|P2|Participant Flow|Adreview - Control Group|AdreView (123I-mIBG): 10 mCi as a single intravenous dose.
1238344|NCT00126438|O2|Outcome|AdreView-Heart Failure Group With Low H/M Ratio|Participants in HF group who had low H/M ratio (less than 1.6).
1238345|NCT00126438|O1|Outcome|AdreView-Heart Failure Group With High H/M Ratio|Participants in HF group who had high H/M ratio (more than or equal to 1.6).
1238346|NCT00126438|E2|Reported Event|Adreview - Control Group|AdreView (123I-mIBG): 10 mCi as a single intravenous dose.
1238347|NCT00126438|E1|Reported Event|AdreView - Heart Failure|AdreView (123I-mIBG): 10 mCi as a single intravenous dose.
1238348|NCT00126425|B3|Baseline|Total|Total of all reporting groups
1238349|NCT00126425|B2|Baseline|AdreView--Control Group|123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose, to participants who were at no risk of heart failure.
1238350|NCT00126425|B1|Baseline|AdreView--Heart Failure Group|123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose, to participants who were at a high risk of heart failure.
1238351|NCT00126425|P2|Participant Flow|AdreView--Control Group|123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose.
1238352|NCT00126425|P1|Participant Flow|AdreView--Heart Failure Group|123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose.
1238353|NCT00126425|O2|Outcome|AdreView-Heart Failure Group With Low H/M Ratio|Participants in HF group who had low H/M ratio (less than 1.6)
1238354|NCT00126425|O1|Outcome|AdreView-Heart Failure Group With High H/M Ratio|Participants in HF group who had high H/M ratio (more than or equal to 1.6)
1238355|NCT00126425|E2|Reported Event|AdreView --Control Group|123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose.
1238356|NCT00126425|E1|Reported Event|AdreView--Heart Failure Group|123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose.
1238357|NCT00126191|B3|Baseline|Total|Total of all reporting groups
1238358|NCT00126191|B2|Baseline|High Risk|Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).
1238359|NCT00126191|B1|Baseline|Low Risk|Regimen A. Single focus of disease less than 10 cm in greatest dimension and a normal LDH. Participants at low risk received three cycles of Regimen A (AAA).
1238360|NCT00126191|P2|Participant Flow|High Risk|Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).
1238361|NCT00126191|P1|Participant Flow|Low Risk|Regimen A. Single focus of disease less than 10 cm in greatest dimension and a normal LDH. Participants at low risk received three cycles of Regimen A (AAA).
1238362|NCT00126191|O2|Outcome|High Risk|Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).
1238363|NCT00126191|O1|Outcome|Low Risk|Regimen A. Single focus of disease less than 10 cm in greatest dimension and a normal LDH. Participants at low risk received three cycles of Regimen A (AAA).
1238364|NCT00126191|O2|Outcome|High Risk|Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).
1238365|NCT00126191|O1|Outcome|Low Risk|Regimen A. Single focus of disease less than 10 cm in greatest dimension and a normal LDH. Participants at low risk received three cycles of Regimen A (AAA).
1238366|NCT00126191|E2|Reported Event|High Risk|Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).
1238367|NCT00126191|E1|Reported Event|Low Risk|Regimen A. Single focus of disease less than 10 cm in greatest dimension and a normal LDH. Participants at low risk received three cycles of Regimen A (AAA).
1238368|NCT00126126|B3|Baseline|Total|Total of all reporting groups
1238369|NCT00126126|B2|Baseline|Wait List Control Group|Those subjects who were randomized to the wait-list control group.
1250406|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
1238373|NCT00126126|O2|Outcome|Wait-List Control Group|These individuals waited 8 weeks in order to begin the intervention.
1238374|NCT00126126|O1|Outcome|Intervention|"Evidence Based Amputee Rehabilitation Program~Exercise: Evidence Based Amputee Rehabilitation Program"
1238375|NCT00126126|O2|Outcome|Wait-List Control Group|These individuals waited 8 weeks in order to begin the intervention.
1238376|NCT00126126|O1|Outcome|Intervention|"Evidence Based Amputee Rehabilitation Program~Exercise: Evidence Based Amputee Rehabilitation Program"
1238377|NCT00126126|E2|Reported Event|Wait-List Control Group|These individuals waited 8 weeks in order to begin the intervention.
1238378|NCT00126126|E1|Reported Event|Intervention|"Evidence Based Amputee Rehabilitation Program~Exercise: Evidence Based Amputee Rehabilitation Program"
1238379|NCT00126113|B3|Baseline|Total|Total of all reporting groups
1238380|NCT00126113|B2|Baseline|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
1238381|NCT00126113|B1|Baseline|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
1238382|NCT00126113|P2|Participant Flow|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
1238383|NCT00126113|P1|Participant Flow|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
1238384|NCT00126113|O2|Outcome|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
1238385|NCT00126113|O1|Outcome|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
1238386|NCT00126113|O2|Outcome|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
1238387|NCT00126113|O1|Outcome|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
1238388|NCT00126113|O2|Outcome|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
1238389|NCT00126113|O1|Outcome|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
1240282|NCT00120406|O2|Outcome|PTA (Control)|Percutaneous balloon angioplasty
1238391|NCT00126113|O1|Outcome|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
1238392|NCT00126113|E2|Reported Event|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
1238393|NCT00126113|E1|Reported Event|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
1238394|NCT00125957|B3|Baseline|Total|Total of all reporting groups
1238395|NCT00125957|B2|Baseline|Placebo-Wellbutrin|Subjects randomly assigned to this arm are given placebo at week 1. They will continue on placebo until week 4, at which time they will cross-over to Wellbutrin 100 mg twice daily (BID). At week 5, active drug is increased to 150mg BID unless subject reports one or more symptoms that are classified as moderate-severe. Subjects continue on active drug until end of study at week 8.
1238396|NCT00125957|B1|Baseline|Wellbutrin-Placebo|Study subjects randomly assigned to this arm of the study will begin on active drug (100 mg twice daily (BID) of Wellbutrin) at week 1. At week 2, active drug is increased to 150mg BID unless subject reports one or more symptoms that are classified as moderate-severe. At week 4, subjects cross over to placebo for remainder of study. Subjects continue on placebo until end of study at week 8.
1238397|NCT00125957|P2|Participant Flow|Placebo First, Then Wellbutrin|Subjects randomly assigned to the Placebo first, then Wellbutrin group will receive placebo until Week 4 when they will cross-over to active drug. At Week 4, subjects will be assigned 100mg Wellbutrin BID. At Week 5, Subjects will be increased to 150mg Wellbutrin BID unless moderate/severe side effects are reported. If subject and rater classify 1+ symptom as severe or 2+ symptoms as moderate, subject will continue on 100mg of Wellbutrin qAM. If subject and rater classify 1+ symptom as moderate or 2+ mild as moderate, subject will continue on bupropion 100mg BID. Subject will continue on the assigned dosage until Week 8 of study.
1238398|NCT00125957|P1|Participant Flow|Wellbutrin First, Then Placebo|Subjects randomly assigned to the Wellbutrin first, then Placebo group will receive 100mg BID of Wellbutrin at the first visit following intake (Week 0).Subjects will be increased to 150mg Wellbutrin BID at Week 1 unless moderate/severe side effects are reported. If subject and rater classify 1+ symptom as severe or 2+ symptoms as moderate, subject will continue on 100mg of bupropion qAM. If subject and rater classify 1+ symptom as moderate or 2+ mild as moderate, subject will continue on Wellbutrin 100mg BID. At Week 4, subjects will cross-over to placebo and will continue to take placebo until Week 8.
1238399|NCT00125957|O2|Outcome|Placebo First, Then Wellbutrin|Subjects randomly assigned to Treatment B will receive Wellbutrin or placebo at Week 1 and will cross over to Wellbutrin or placebo at week 4.
1238400|NCT00125957|O1|Outcome|Wellbutrin First, Then Placebo|Subjects randomly assigned to Treatment A will receive Wellbutrin or placebo at Week 1 and will cross over to Wellbutrin or placebo at week 4.
1238401|NCT00125957|O2|Outcome|Placebo First, Then Wellbutrin|Subjects randomly assigned to Treatment B will receive Wellbutrin or placebo at Week 1 and will cross over to Wellbutrin or placebo at week 4.
1238402|NCT00125957|O1|Outcome|Wellbutrin First, Then Placebo|Subjects randomly assigned to Treatment A will receive Wellbutrin or placebo at Week 1 and will cross over to Wellbutrin or placebo at week 4.
1238403|NCT00125957|E2|Reported Event|Placebo-Bupropion|Subjects randomly assigned to this arm are given placebo at week 1. They will continue on placebo until week 4, at which time they will cross-over to bupropion 100 mg BID. At week 5, active drug is increased to 150mg BID unless subject reports one or more symptoms that are classified as moderate-severe. Subjects continue on active drug until end of study at week 8.
1238404|NCT00125957|E1|Reported Event|Bupropion-Placebo|Study subjects randomly assigned to this arm of the study will begin on active drug (100 mg BID bupropion) at week 1. At week 2, active drug is increased to 150mg BID unless subject reports one or more symptoms that are classified as moderate-severe. At week 4, subjects cross over to placebo for remainder of study. Subjects continue on placebo until end of study at week 8.
1238406|NCT00125931|P1|Participant Flow|Treatment Group|Open label group with pentazocine treatment.
1238407|NCT00125931|O1|Outcome|Open Label Group|Mania symptoms with pentazocine compared to baseline symptoms.
1238408|NCT00125931|O1|Outcome|Open Label Group|Mania symptoms with pentazocine compared to baseline symptoms.
1238409|NCT00125931|E1|Reported Event|Open Label Group|Mania symptoms with pentazocine compared to baseline symptoms.
1238410|NCT00125619|B3|Baseline|Total|Total of all reporting groups
1238411|NCT00125619|B2|Baseline|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
1238412|NCT00125619|B1|Baseline|Arm 2: Robot-assisted|"Rehabilitation for Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
1238413|NCT00125619|P2|Participant Flow|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
1238414|NCT00125619|P1|Participant Flow|Arm 2: Robot-assisted|"Rehabilitation got Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
1238415|NCT00125619|O2|Outcome|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
1238416|NCT00125619|O1|Outcome|Arm 2: Robot-assisted|"Rehabilitation got Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
1238417|NCT00125619|O2|Outcome|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
1238418|NCT00125619|O1|Outcome|Arm 2: Robot-assisted|"Rehabilitation got Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
1238869|NCT00124709|O1|Outcome|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
1238419|NCT00125619|O2|Outcome|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
1238420|NCT00125619|O1|Outcome|Arm 2: Robot-assisted|"Rehabilitation got Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
1238421|NCT00125619|O2|Outcome|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
1238422|NCT00125619|O1|Outcome|Arm 2: Robot-assisted|"Rehabilitation got Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
1238423|NCT00125619|O2|Outcome|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
1238424|NCT00125619|O1|Outcome|Arm 2: Robot-assisted|"Rehabilitation got Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
1238425|NCT00125619|O2|Outcome|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
1238426|NCT00125619|O1|Outcome|Arm 2: Robot-assisted|"Rehabilitation got Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
1238427|NCT00125619|O2|Outcome|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
1238428|NCT00125619|O1|Outcome|Arm 2: Robot-assisted|"Rehabilitation for Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
1238429|NCT00125619|E2|Reported Event|Arm 1|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
1238430|NCT00125619|E1|Reported Event|ARM2|"Rehabilitation got Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
1238431|NCT00125593|B3|Baseline|Total|Total of all reporting groups
1238432|NCT00125593|B2|Baseline|Placebo|Once daily tablet
1238433|NCT00125593|B1|Baseline|Simvastatin Plus Ezetimibe|Once daily tablet
1238434|NCT00125593|P2|Participant Flow|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
1238435|NCT00125593|P1|Participant Flow|Simvastatin 20mg Plus Ezetimibe 10mg|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
1238436|NCT00125593|O2|Outcome|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
1238470|NCT00125515|O3|Outcome|Memantine 15 mg Bid|memantine 15 mg bid plus oral naltrexone
1238471|NCT00125515|O2|Outcome|Memantine 30 mg Bid|Memantine 30 mg bid plus oral naltrexone
1238437|NCT00125593|O1|Outcome|Simvastatin Plus Ezetimibe|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
1238438|NCT00125593|O2|Outcome|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
1238439|NCT00125593|O1|Outcome|Simvastatin Plus Ezetimibe|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
1238440|NCT00125593|O2|Outcome|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
1238441|NCT00125593|O1|Outcome|Simvastatin Plus Ezetimibe|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
1238442|NCT00125593|O2|Outcome|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
1238443|NCT00125593|O1|Outcome|Simvastatin Plus Ezetimibe|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
1238775|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
1238444|NCT00125593|O2|Outcome|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
1238445|NCT00125593|O1|Outcome|Simvastatin Plus Ezetimibe|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
1238446|NCT00125593|O2|Outcome|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
1238447|NCT00125593|O1|Outcome|Simvastatin Plus Ezetimibe|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
1238448|NCT00125593|O2|Outcome|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
1238449|NCT00125593|O1|Outcome|Simvastatin Plus Ezetimibe|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
1238450|NCT00125593|E2|Reported Event|Placebo|Once daily tablet
1238451|NCT00125593|E1|Reported Event|Simvastatin Plus Ezetimibe|Once daily tablet
1238452|NCT00125528|B3|Baseline|Total|Total of all reporting groups
1238453|NCT00125528|B2|Baseline|Placebo|placebo: placebo bid
1238454|NCT00125528|B1|Baseline|D-cycloserine|D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
1238455|NCT00125528|P2|Participant Flow|Placebo|placebo: placebo bid
1238456|NCT00125528|P1|Participant Flow|D-cycloserine|D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
1238457|NCT00125528|O2|Outcome|Placebo|placebo: placebo bid
1238458|NCT00125528|O1|Outcome|D-cycloserine|D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
1238459|NCT00125528|O2|Outcome|Placebo|placebo: placebo bid
1238460|NCT00125528|O1|Outcome|D-cycloserine|D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
1238461|NCT00125528|E2|Reported Event|Placebo|placebo: placebo bid
1238462|NCT00125528|E1|Reported Event|D-cycloserine|D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
1238463|NCT00125515|B4|Baseline|Total|Total of all reporting groups
1238464|NCT00125515|B3|Baseline|Memantine 15 mg Bid|memantine 15 mg bid plus oral naltrexone
1238465|NCT00125515|B2|Baseline|Memantine 30 mg Bid|Memantine 30 mg bid plus oral naltrexone
1238466|NCT00125515|B1|Baseline|Placebo|Placebo plus oral naltrexone
1238467|NCT00125515|P3|Participant Flow|Memantine 15 mg Bid|memantine 15 mg bid plus oral naltrexone
1238468|NCT00125515|P2|Participant Flow|Memantine 30 mg Bid|Memantine 30 mg bid plus oral naltrexone
1238469|NCT00125515|P1|Participant Flow|Placebo|Placebo plus oral naltrexone
1238473|NCT00125515|E3|Reported Event|Memantine 15 mg Bid|memantine 15 mg bid plus oral naltrexone
1238474|NCT00125515|E2|Reported Event|Memantine 30 mg Bid|Memantine 30 mg bid plus oral naltrexone
1238475|NCT00125515|E1|Reported Event|Placebo|Placebo plus oral naltrexone
1238476|NCT00125268|B3|Baseline|Total|Total of all reporting groups
1238477|NCT00125268|B2|Baseline|Sham|Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
1238478|NCT00125268|B1|Baseline|MIRE|Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).
1238479|NCT00125268|P2|Participant Flow|Sham|Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
1238480|NCT00125268|P1|Participant Flow|MIRE|Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).
1238481|NCT00125268|O2|Outcome|Sham|Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
1238482|NCT00125268|O1|Outcome|MIRE|Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).
1238483|NCT00125268|O2|Outcome|Sham|Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
1238484|NCT00125268|O1|Outcome|MIRE|Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).
1238485|NCT00125268|O2|Outcome|Sham|Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
1238486|NCT00125268|O1|Outcome|MIRE|Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).
1238487|NCT00125268|E2|Reported Event|Sham|Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
1238488|NCT00125268|E1|Reported Event|MIRE|Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).
1238489|NCT00125242|B3|Baseline|Total|Total of all reporting groups
1238490|NCT00125242|B2|Baseline|Non Treatment Stimuli Development Participants|Participants for stimuli development provided normative data for stimuli development. e.g., Treatment items were grouped according to typicality of category membership (apple - typical fruit; coconut - atypical fruit). These participants provided the reponses that served as the basis for classifying/organizing stimuli. Because data from this group were used only for the purposes of stimuli development, no findings are reported for this group. See Cameron, R.M., Wambaugh, J.L., & Mauszycki, S. (2008). Effects of age, gender and education on semantic fluency for living and artifact categories. Aphasiology, 22(7/8), 790-801, doi: 10.1080/02687030701818018 for related findings.
1238491|NCT00125242|B1|Baseline|SFA Treatment Participants|Semantic Feature Analysis (SFA) is a word-retrieval treatment for aphasia. SFA entails having the speech-language pathologist (SLP) guide the participant through generation of pertinent semantic features for pictured treatment items (e.g., category membership, physical description, location of item in context, personal associations, associated actions). For some participants, treatment items were grouped by typicality of category membership (e.g, robin-typical bird and penguin-atypical bird). Training of atypical items may stimulate a broader semantic activation of the category and thus, may promote greater generalization. Treatment was applied sequentially to sets of items in single-subject, multiple baseline designs. Thus, replication of treatment effects could be evaluated within and across participants. Treatment was administered by SLPs three times per week until prescribed accuracy levels were met during probes or a maximum number of treatment sessions was completed.
1238492|NCT00125242|P2|Participant Flow|SFA Treatment Participants|Stroke survivors who received experimental therapy
1238493|NCT00125242|P1|Participant Flow|Non Treatment Stimuli Development Participants|Non-brain-injured participants who were enrolled for the purpose of stimuli development
1238494|NCT00125242|O1|Outcome|SFA Treatment Participants|Stroke survivors received Semantic Feature Analysis for the treatment of word-retrieval deficits. Each SFA treatment participant received word-retrieval therapy applied sequentially to experimental lists of items. Effect sizes were calculated for each participant for each list. An average effect size was calculated for each participant and an overall average was determined for all participants as a group.
1238495|NCT00125242|E2|Reported Event|NonTreatment Stimuli Development Participants|Non-brain-injured participants who were utilized to develop treatment stimuli.
1238496|NCT00125242|E1|Reported Event|SFA Treatment Participants|"Stroke-survivors who received Semantic Feature Analysis therapy for aphasic word-retrieval deficits~Semantic Feature Training: The treatment is designed to stimulate the semantic feature network so that it may serve as not only a mechanism for improving disrupted lexical semantic processing, but also as a compensatory strategy during word retrieval failures."
1238497|NCT00125190|B1|Baseline|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
1238498|NCT00125190|P1|Participant Flow|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
1238499|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
1238500|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
1238501|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
1238632|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1250407|NCT00091793|O2|Outcome|Placebo|
1238502|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
1238503|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
1238504|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
1238505|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
1238506|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
1238507|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
1238508|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
1238509|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
1238510|NCT00125190|E1|Reported Event|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
1238511|NCT00125164|B5|Baseline|Total|Total of all reporting groups
1238512|NCT00125164|B4|Baseline|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
1238514|NCT00125164|B2|Baseline|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
1238515|NCT00125164|B1|Baseline|Untreated|Observational Group
1238516|NCT00125164|P4|Participant Flow|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
1238517|NCT00125164|P3|Participant Flow|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
1238518|NCT00125164|P2|Participant Flow|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
1238519|NCT00125164|P1|Participant Flow|Untreated|Observational Group
1238520|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
1238521|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
1238522|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
1238523|NCT00125164|O1|Outcome|Untreated|Observational Group
1238524|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
1238525|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
1238526|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
1238527|NCT00125164|O1|Outcome|Untreated|Observational Group
1238528|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
1238529|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
1238530|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
1238531|NCT00125164|O1|Outcome|Untreated|Observational Group
1238532|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
1238533|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
1238534|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
1238535|NCT00125164|O1|Outcome|Untreated|Observational Group
1238536|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
1238537|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
1238633|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1238932|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
1238538|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
1238539|NCT00125164|O1|Outcome|Untreated|Observational Group
1238540|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
1238541|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
1238542|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
1238543|NCT00125164|O1|Outcome|Untreated|Observational Group
1238544|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
1238545|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
1238546|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
1238547|NCT00125164|O1|Outcome|Untreated|Observational Group
1238548|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
1238549|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
1238550|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
1238551|NCT00125164|O1|Outcome|Untreated|Observational Group
1238552|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
1238553|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
1238554|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
1238558|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
1238559|NCT00125164|O1|Outcome|Untreated|Observational Group
1238560|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
1238561|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
1238562|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
1238563|NCT00125164|O1|Outcome|Untreated|Observational Group
1238564|NCT00125164|E4|Reported Event|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
1238565|NCT00125164|E3|Reported Event|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
1238566|NCT00125164|E2|Reported Event|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
1238567|NCT00125164|E1|Reported Event|Untreated|Observational Group
1238568|NCT00125138|B5|Baseline|Total|Total of all reporting groups
1238569|NCT00125138|B4|Baseline|Placebo|Syrup with 0.3 mg/mL quinine orally QHS
1238570|NCT00125138|B3|Baseline|Melperone HCl - 60 mg|5 mg/mL Melperone syrup orally QHS
1238571|NCT00125138|B2|Baseline|Melperone HCl - 40 mg|5 mg/mL Melperone syrup orally QHS
1238572|NCT00125138|B1|Baseline|Melperone HCl - 20 mg|5 mg/mL Melperone syrup orally QHS
1238573|NCT00125138|P4|Participant Flow|Placebo|Syrup with 0.3 mg/mL quinine orally QHS
1238574|NCT00125138|P3|Participant Flow|Melperone HCl - 60 mg|5 mg/mL Melperone syrup orally QHS
1238575|NCT00125138|P2|Participant Flow|Melperone HCl - 40 mg|5 mg/mL Melperone syrup orally QHS
1238576|NCT00125138|P1|Participant Flow|Melperone HCl - 20 mg|5 mg/mL Melperone syrup orally QHS
1238577|NCT00125138|O4|Outcome|Placebo|Syrup with 0.3 mg/mL quinine orally QHS
1238578|NCT00125138|O3|Outcome|Melperone HCl - 60 mg|5 mg/mL Melperone syrup orally QHS
1238579|NCT00125138|O2|Outcome|Melperone HCl - 40 mg|5 mg/mL Melperone syrup orally QHS
1238580|NCT00125138|O1|Outcome|Melperone HCl - 20 mg|5 mg/mL Melperone syrup orally QHS
1238581|NCT00125138|O4|Outcome|Placebo|Syrup with 0.3 mg/mL quinine orally QHS
1238582|NCT00125138|O3|Outcome|Melperone HCl - 60 mg|5 mg/mL Melperone syrup orally QHS
1238583|NCT00125138|O2|Outcome|Melperone HCl - 40 mg|5 mg/mL Melperone syrup orally QHS
1238584|NCT00125138|O1|Outcome|Melperone HCl - 20 mg|5 mg/mL Melperone syrup orally QHS
1238585|NCT00125138|E4|Reported Event|Placebo|Syrup with 0.3 mg/mL quinine orally QHS
1238586|NCT00125138|E3|Reported Event|Melperone HCl - 60 mg|5 mg/mL Melperone syrup orally QHS
1238587|NCT00125138|E2|Reported Event|Melperone HCl - 40 mg|5 mg/mL Melperone syrup orally QHS
1238588|NCT00125138|E1|Reported Event|Melperone HCl - 20 mg|5 mg/mL Melperone syrup orally QHS
1238589|NCT00125034|B3|Baseline|Total|Total of all reporting groups
1250408|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
1238590|NCT00125034|B2|Baseline|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
1238591|NCT00125034|B1|Baseline|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
1238592|NCT00125034|P2|Participant Flow|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
1238593|NCT00125034|P1|Participant Flow|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
1238594|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
1238608|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
1238595|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
1238596|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
1238597|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
1238598|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
1238599|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
1238600|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
1238601|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
1238634|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1238602|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
1238603|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
1238604|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
1238605|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
1238606|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
1238607|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
1238609|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
1238610|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
1238611|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
1238612|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
1238613|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
1238614|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
1238615|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
1238616|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
1238617|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
1238618|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
1238619|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
1238620|NCT00125034|E2|Reported Event|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
1238621|NCT00125034|E1|Reported Event|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
1238623|NCT00124982|B2|Baseline|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238624|NCT00124982|B1|Baseline|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238625|NCT00124982|P3|Participant Flow|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1238626|NCT00124982|P2|Participant Flow|ST-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238627|NCT00124982|P1|Participant Flow|Short Term (ST) Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238628|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1238629|NCT00124982|O1|Outcome|Open-label Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238630|NCT00124982|O1|Outcome|Open-label Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238631|NCT00124982|O1|Outcome|Open-label Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238933|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
1238635|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1238636|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1238637|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1238638|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1238639|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1238640|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1238641|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1238642|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1238643|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1238644|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1238645|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1238646|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1238647|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238870|NCT00124709|O2|Outcome|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
1238648|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238649|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238650|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238651|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238652|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238653|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1238654|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1238655|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1238656|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1238657|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1238658|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1238659|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1238660|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1238661|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1238662|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1250409|NCT00091793|O2|Outcome|Placebo|
1238663|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1238664|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1238665|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1238666|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1238667|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1238668|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1238669|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1238670|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
1238671|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238672|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238673|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238674|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238675|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238676|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238677|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238678|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238679|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238680|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238681|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238718|NCT00124943|O3|Outcome|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
1238934|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
1238682|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238683|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238684|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238685|NCT00124982|O1|Outcome|All Treated Participants|Open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238686|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238687|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238688|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238909|NCT00124657|E5|Reported Event|Phase II|Phase II participants received 120 mg/m^2.
1238689|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238690|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238691|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238692|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238693|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238694|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238695|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238696|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238697|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238698|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238699|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238700|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238701|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
1238702|NCT00124982|E2|Reported Event|Abatacept (ST)|
1238703|NCT00124982|E1|Reported Event|Abatacept (LT)|
1238704|NCT00124943|B5|Baseline|Total|Total of all reporting groups
1238705|NCT00124943|B4|Baseline|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
1238706|NCT00124943|B3|Baseline|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
1239264|NCT00123409|E2|Reported Event|Arm 2|"Usual Care~Usual Care: Usual care"
1238707|NCT00124943|B2|Baseline|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
1238708|NCT00124943|B1|Baseline|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
1238709|NCT00124943|P4|Participant Flow|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
1238710|NCT00124943|P3|Participant Flow|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
1238711|NCT00124943|P2|Participant Flow|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
1238712|NCT00124943|P1|Participant Flow|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
1238713|NCT00124943|O4|Outcome|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
1238714|NCT00124943|O3|Outcome|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
1238715|NCT00124943|O2|Outcome|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
1238716|NCT00124943|O1|Outcome|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
1238717|NCT00124943|O4|Outcome|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
1238817|NCT00124735|O8|Outcome|Rocuronium Continuous Infusion Maintenance - Toddlers (IT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
1238719|NCT00124943|O2|Outcome|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
1238720|NCT00124943|O1|Outcome|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
1238721|NCT00124943|O4|Outcome|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
1238722|NCT00124943|O3|Outcome|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
1238723|NCT00124943|O2|Outcome|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
1238724|NCT00124943|O1|Outcome|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
1238725|NCT00124943|O4|Outcome|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
1238726|NCT00124943|O3|Outcome|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
1238727|NCT00124943|O2|Outcome|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
1238728|NCT00124943|O1|Outcome|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
1251572|NCT00089661|O1|Outcome|Denosumab 60 mg Q6M|
1238729|NCT00124943|O4|Outcome|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
1238730|NCT00124943|O3|Outcome|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
1238731|NCT00124943|O2|Outcome|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
1238732|NCT00124943|O1|Outcome|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
1238733|NCT00124943|O4|Outcome|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
1238734|NCT00124943|O3|Outcome|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
1238735|NCT00124943|O2|Outcome|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
1238736|NCT00124943|O1|Outcome|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
1238737|NCT00124943|O4|Outcome|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
1238738|NCT00124943|O3|Outcome|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
1238739|NCT00124943|O2|Outcome|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
1238740|NCT00124943|O1|Outcome|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
1238741|NCT00124943|O4|Outcome|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
1238742|NCT00124943|O3|Outcome|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
1238743|NCT00124943|O2|Outcome|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
1238744|NCT00124943|O1|Outcome|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
1238745|NCT00124943|E4|Reported Event|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
1238746|NCT00124943|E3|Reported Event|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
1238747|NCT00124943|E2|Reported Event|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
1238748|NCT00124943|E1|Reported Event|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
1238749|NCT00124748|B3|Baseline|Total|Total of all reporting groups
1238750|NCT00124748|B2|Baseline|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
1238751|NCT00124748|B1|Baseline|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
1251573|NCT00089661|O2|Outcome|Placebo|
1238752|NCT00124748|P2|Participant Flow|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
1238753|NCT00124748|P1|Participant Flow|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
1238754|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
1238755|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
1238756|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
1238757|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
1238758|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
1238759|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
1238760|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
1238761|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
1238762|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
1238763|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
1238930|NCT00124449|P2|Participant Flow|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
1239239|NCT00123422|B4|Baseline|Total|Total of all reporting groups
1238764|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
1238765|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
1238766|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
1238767|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
1238768|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
1238769|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
1238770|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
1238771|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
1238772|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
1238773|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
1238774|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
1238867|NCT00124709|O1|Outcome|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
1238776|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
1238777|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
1238778|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
1238779|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
1238780|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
1238781|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
1238782|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
1238783|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
1238784|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
1238785|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
1238786|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
1238787|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
1238788|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
1238789|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
1238790|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
1238791|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
1238792|NCT00124748|E2|Reported Event|Imatinib 800mg|Patients randomized to receive 800 mg imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
1238793|NCT00124748|E1|Reported Event|Imatinib 400mg|Oral dose of 400mg imatinib once daily. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
1238794|NCT00124735|B11|Baseline|Total|Total of all reporting groups
1238795|NCT00124735|B10|Baseline|Rocuronium Continuous Infusion Maintenance - Adolescents (IA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
1238796|NCT00124735|B9|Baseline|Rocuronium Continuous Infusion Maintenance - Children (IC)|Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
1238797|NCT00124735|B8|Baseline|Rocuronium Continuous Infusion Maintenance - Toddlers (IT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
1238798|NCT00124735|B7|Baseline|Rocuronium Continuous Infusion Maintenance - Infants (II)|Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
1238799|NCT00124735|B6|Baseline|Rocuronium Continuous Infusion Maintenance - Neonates (IN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
1238800|NCT00124735|B5|Baseline|Rocuronium Bolus Maintenance - Adolescents (BA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
1238868|NCT00124709|O2|Outcome|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
1238801|NCT00124735|B4|Baseline|Rocuronium Bolus Maintenance -Children (BC)|Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
1238802|NCT00124735|B3|Baseline|Rocuronium Bolus Maintenance - Toddlers (BT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
1238803|NCT00124735|B2|Baseline|Rocuronium Bolus Maintenance - Infants (BI)|Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
1238804|NCT00124735|B1|Baseline|Rocuronium Bolus Maintenance - Neonate (BN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
1238805|NCT00124735|P10|Participant Flow|Rocuronium Continuous Infusion Maintenance - Adolescents (IA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
1238806|NCT00124735|P9|Participant Flow|Rocuronium Continuous Infusion Maintenance - Children (IC)|Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
1238807|NCT00124735|P8|Participant Flow|Rocuronium Continuous Infusion Maintenance - Toddlers (IT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
1238808|NCT00124735|P7|Participant Flow|Rocuronium Continuous Infusion Maintenance - Infants (II)|Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
1238809|NCT00124735|P6|Participant Flow|Rocuronium Continuous Infusion Maintenance - Neonates (IN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
1238810|NCT00124735|P5|Participant Flow|Rocuronium Bolus Maintenance - Adolescents (BA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
1238811|NCT00124735|P4|Participant Flow|Rocuronium Bolus Maintenance -Children (BC)|Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
1238812|NCT00124735|P3|Participant Flow|Rocuronium Bolus Maintenance - Toddlers (BT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
1238813|NCT00124735|P2|Participant Flow|Rocuronium Bolus Maintenance - Infants (BI)|Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
1238814|NCT00124735|P1|Participant Flow|Rocuronium Bolus Maintenance - Neonate (BN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
1238815|NCT00124735|O10|Outcome|Rocuronium Continuous Infusion Maintenance - Adolescents (IA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
1238816|NCT00124735|O9|Outcome|Rocuronium Continuous Infusion Maintenance - Children (IC)|Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
1238818|NCT00124735|O7|Outcome|Rocuronium Continuous Infusion Maintenance - Infants (II)|Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
1238819|NCT00124735|O6|Outcome|Rocuronium Continuous Infusion Maintenance - Neonates (IN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
1238820|NCT00124735|O5|Outcome|Rocuronium Bolus Maintenance - Adolescents (BA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
1238821|NCT00124735|O4|Outcome|Rocuronium Bolus Maintenance -Children (BC)|Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
1238822|NCT00124735|O3|Outcome|Rocuronium Bolus Maintenance - Toddlers (BT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
1238823|NCT00124735|O2|Outcome|Rocuronium Bolus Maintenance - Infants (BI)|Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
1238824|NCT00124735|O1|Outcome|Rocuronium Bolus Maintenance - Neonate (BN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
1238825|NCT00124735|O10|Outcome|Rocuronium Continuous Infusion Maintenance - Adolescents (IA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
1238826|NCT00124735|O9|Outcome|Rocuronium Continuous Infusion Maintenance - Children (IC)|Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
1238827|NCT00124735|O8|Outcome|Rocuronium Continuous Infusion Maintenance - Toddlers (IT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
1238828|NCT00124735|O7|Outcome|Rocuronium Continuous Infusion Maintenance - Infants (II)|Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
1238829|NCT00124735|O6|Outcome|Rocuronium Continuous Infusion Maintenance - Neonates (IN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
1238830|NCT00124735|O5|Outcome|Rocuronium Bolus Maintenance - Adolescents (BA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
1238831|NCT00124735|O4|Outcome|Rocuronium Bolus Maintenance -Children (BC)|Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
1238832|NCT00124735|O3|Outcome|Rocuronium Bolus Maintenance - Toddlers (BT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
1238833|NCT00124735|O2|Outcome|Rocuronium Bolus Maintenance - Infants (BI)|Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
1238834|NCT00124735|O1|Outcome|Rocuronium Bolus Maintenance - Neonate (BN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
1238835|NCT00124735|O10|Outcome|Rocuronium Continuous Infusion Maintenance - Adolescents (IA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
1238836|NCT00124735|O9|Outcome|Rocuronium Continuous Infusion Maintenance - Children (IC)|Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
1238837|NCT00124735|O8|Outcome|Rocuronium Continuous Infusion Maintenance - Toddlers (IT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
1238838|NCT00124735|O7|Outcome|Rocuronium Continuous Infusion Maintenance - Infants (II)|Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
1238839|NCT00124735|O6|Outcome|Rocuronium Continuous Infusion Maintenance - Neonates (IN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
1238840|NCT00124735|O5|Outcome|Rocuronium Bolus Maintenance - Adolescents (BA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
1238841|NCT00124735|O4|Outcome|Rocuronium Bolus Maintenance -Children (BC)|Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
1238842|NCT00124735|O3|Outcome|Rocuronium Bolus Maintenance - Toddlers (BT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
1238843|NCT00124735|O2|Outcome|Rocuronium Bolus Maintenance - Infants (BI)|Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
1238844|NCT00124735|O1|Outcome|Rocuronium Bolus Maintenance - Neonate (BN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
1238845|NCT00124735|O10|Outcome|Rocuronium Continuous Infusion Maintenance - Adolescents (IA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
1238846|NCT00124735|O9|Outcome|Rocuronium Continuous Infusion Maintenance - Children (IC)|Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
1238847|NCT00124735|O8|Outcome|Rocuronium Continuous Infusion Maintenance - Toddlers (IT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
1238848|NCT00124735|O7|Outcome|Rocuronium Continuous Infusion Maintenance - Infants (II)|Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
1238849|NCT00124735|O6|Outcome|Rocuronium Continuous Infusion Maintenance - Neonates (IN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
1238850|NCT00124735|O5|Outcome|Rocuronium Bolus Maintenance - Adolescents (BA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
1238851|NCT00124735|O4|Outcome|Rocuronium Bolus Maintenance -Children (BC)|Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
1238852|NCT00124735|O3|Outcome|Rocuronium Bolus Maintenance - Toddlers (BT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
1238853|NCT00124735|O2|Outcome|Rocuronium Bolus Maintenance - Infants (BI)|Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
1238854|NCT00124735|O1|Outcome|Rocuronium Bolus Maintenance - Neonate (BN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
1238855|NCT00124735|E2|Reported Event|Rocuronium Continuous Infusion Maintenance|Subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation (includes neonates, infants, toddlers, children, and adolescents)
1238856|NCT00124735|E1|Reported Event|Rocuronium Bolus Maintenance|Subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation (includes neonates, infants, toddlers, children, and adolescents).
1238857|NCT00124709|B3|Baseline|Total|Total of all reporting groups
1238858|NCT00124709|B2|Baseline|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
1238859|NCT00124709|B1|Baseline|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
1238860|NCT00124709|P2|Participant Flow|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
1238861|NCT00124709|P1|Participant Flow|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
1238862|NCT00124709|O2|Outcome|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
1238863|NCT00124709|O1|Outcome|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
1238864|NCT00124709|O2|Outcome|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
1238865|NCT00124709|O1|Outcome|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
1238866|NCT00124709|O2|Outcome|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
1251574|NCT00089661|O1|Outcome|Denosumab 60 mg Q6M|
1238871|NCT00124709|O1|Outcome|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
1238872|NCT00124709|E2|Reported Event|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
1238873|NCT00124709|E1|Reported Event|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
1238874|NCT00124657|B4|Baseline|Total|Total of all reporting groups
1238875|NCT00124657|B3|Baseline|Phase II Only|39 participants were enrolled on the Phase II portion of the trial only.
1238876|NCT00124657|B2|Baseline|Phase I and Phase II|5 patients participated in both the Phase I portion and the Phase II portion of the study.
1238877|NCT00124657|B1|Baseline|Phase I Only|18 participants were enrolled on the Phase I portion of the trial only.
1238878|NCT00124657|P3|Participant Flow|Phase II Only|39 participants were enrolled on the Phase II portion of the trial only.
1238879|NCT00124657|P2|Participant Flow|Phase I and Phase II|5 patients participated in both the Phase I portion and the Phase II portion of the study.
1238880|NCT00124657|P1|Participant Flow|Phase I Only|18 participants were enrolled on the Phase I portion of the trial only.
1238881|NCT00124657|O2|Outcome|Grade 4 Toxicity|Grade 4 toxicity per CTCAE 3.0.
1238882|NCT00124657|O1|Outcome|Grade 3 Toxicity|Grade 3 toxicity per CTCAE 3.0.
1238883|NCT00124657|O1|Outcome|Patients With High-Grade/Low-Grade Glioma|"Participants included patients with newly diagnosed high-grade glioma (excluding those originating in the brain stem) and unfavorable low-grade glioma who are ≥ 3 years and <26 years of age. Patients receiving enzyme-inducing anticonvulsants (EIACs) were not eligible for this study.~Patients received erlotinib hydrochloride: In the Phase II component of this study, erlotinib was given at the MTD during and after RT for 2 years. The recommended dose of erlotinib for the Phase II component of the current study was 120mg/m^2 per day (maximum dose of 200mg per day)."
1238884|NCT00124657|O1|Outcome|Patients With High-Grade/Low-Grade Glioma|"Patients with newly diagnosed high-grade glioma (excluding those originating in the brain stem) and unfavorable low-grade glioma who are ≥ 3 years and <26 years of age. Patients receiving enzyme-inducing anticonvulsants (EIACs) are not eligible for this study. Patients with spinal cord tumors will be eligible for the Phase I and Phase II component of this study, but they will not be taken into consideration to estimate PFS in the Phase II component of this trial because of their notoriously worse prognosis. Patients receive erlotinib hydrochloride.~Erlotinib hydrochloride: This study had 2 components: a Phase I component which estimated the MTD and DLT(s) of erlotinib given once a day during and after conventionally fractionated RT for a period of 8 weeks (DLT-evaluation period), followed by continuous administration of this medication for up to 3 years; and a Phase II component where erlotinib was given at the MTD during and after RT for 2 years."
1238885|NCT00124657|O1|Outcome|Patients With High-Grade/Low-Grade Glioma|"Participants included patients with newly diagnosed high-grade glioma (excluding those originating in the brain stem) and unfavorable low-grade glioma who are ≥ 3 years and <26 years of age. Patients receiving enzyme-inducing anticonvulsants (EIACs) were not eligible for this study.~Patients received erlotinib hydrochloride: In the Phase II component of this study, erlotinib was given at the MTD during and after RT for 2 years. The recommended dose of erlotinib for the Phase II component of the current study was 120mg/m^2 per day (maximum dose of 200mg per day)."
1238931|NCT00124449|P1|Participant Flow|Abatacept|Abatacept by intravenous (IV) infusion, dose based on participant’s body weight at the screening visit
1250410|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
1238886|NCT00124657|O1|Outcome|Patients With High-Grade/Low-Grade Glioma|"Participants included patients with newly diagnosed high-grade glioma (excluding those originating in the brain stem) and unfavorable low-grade glioma who are ≥ 3 years and <26 years of age. Patients receiving enzyme-inducing anticonvulsants (EIACs) were not eligible for this study.~Patients received erlotinib hydrochloride: In the Phase II component of this study, erlotinib was given at the MTD during and after RT for 2 years. The recommended dose of erlotinib for the Phase II component of the current study was 120mg/m^2 per day (maximum dose of 200mg per day)."
1238887|NCT00124657|O4|Outcome|Phase II GBM|Participants with a diagnosis of intracranial glioblastoma multiforme (GBM) treated with a combination of maximum safe surgical resection, local RT, and erlotinib.
1238888|NCT00124657|O3|Outcome|Phase II AA|Participants with a diagnosis of intracranial anaplastic astrocytoma (AA) treated with a combination of maximum safe surgical resection, local RT, and erlotinib.
1238889|NCT00124657|O2|Outcome|Phase I GBM|All participants with a diagnosis of glioblastoma multiforme (GBM) and treated on Phase I.
1238890|NCT00124657|O1|Outcome|Phase I AA|All participants with a diagnosis of anaplastic astrocytoma (AA) and treated on Phase I.
1238891|NCT00124657|O1|Outcome|Phase I|22 participants were analyzed for MLT over 4 dose levels.
1238892|NCT00124657|O1|Outcome|Phase I|Phase I participants
1238893|NCT00124657|O4|Outcome|160 mg/m^2|Dose level 4 was 160 mg/m^2, range of actual dosage was 151.5-167 mg/m^2.
1238894|NCT00124657|O3|Outcome|120 mg/m^2|Dose level 3 was 120 mg/m^2, range of actual dosage was 107-128 mg/m^2.
1238895|NCT00124657|O2|Outcome|90 mg/m^2|Dose level 2 was 90 mg/m^2, range of actual dosage was 85-87.5 mg/m^2.
1238896|NCT00124657|O1|Outcome|70 mg/m^2|Dose level 1 was 70 mg/m^2, range of actual dosage was 68-83 mg/m^2.
1238897|NCT00124657|O4|Outcome|160 mg/m^2|Dose level 4 was 160 mg/m^2, range of actual dosage was 151.5-167 mg/m^2.
1238898|NCT00124657|O3|Outcome|120 mg/m^2|Dose level 3 was 120 mg/m^2, range of actual dosage was 107-128 mg/m^2.
1238899|NCT00124657|O2|Outcome|90 mg/m^2|Dose level 2 was 90 mg/m^2, range of actual dosage was 85-87.5 mg/m^2.
1238900|NCT00124657|O1|Outcome|70 mg/m^2|Dose level 1 was 70 mg/m^2, range of actual dosage was 68-83 mg/m^2.
1238901|NCT00124657|O4|Outcome|160 mg/m^2|Dose level 4 was 160 mg/m^2, range of actual dosage was 151.5-167 mg/m^2.
1238902|NCT00124657|O3|Outcome|120 mg/m^2|Dose level 3 was 120 mg/m^2, range of actual dosage was 107-128 mg/m^2.
1238903|NCT00124657|O2|Outcome|90 mg/m^2|Dose level 2 was 90 mg/m^2, range of actual dosage was 85-87.5 mg/m^2.
1238904|NCT00124657|O1|Outcome|70 mg/m^2|Dose level 1 was 70 mg/m^2, range of actual dosage was 68-83 mg/m^2.
1238905|NCT00124657|O4|Outcome|160 mg/m^2|Dose level 4 was 160 mg/m^2, range of actual dosage was 151.5-167 mg/m^2.
1238906|NCT00124657|O3|Outcome|120 mg/m^2|Dose level 3 was 120 mg/m^2, range of actual dosage was 107-128 mg/m^2.
1238907|NCT00124657|O2|Outcome|90 mg/m^2|Dose level 2 was 90 mg/m^2, range of actual dosage was 85-87.5 mg/m^2.
1238908|NCT00124657|O1|Outcome|70 mg/m^2|Dose level 1 was 70 mg/m^2, range of actual dosage was 68-83 mg/m^2.
1238910|NCT00124657|E4|Reported Event|160 mg/m^2 (Phase I)|Participants received dose of 160 mg/m^2, range of actual dose was 151.5-167 mg/m^2.
1238911|NCT00124657|E3|Reported Event|120 mg/m^2 (Phase I)|Participants received dose of 120 mg/m^2, range of actual dose was 107-128 mg/m^2.
1238912|NCT00124657|E2|Reported Event|90 mg/m^2 (Phase I)|Participants received dose of 90 mg/m^2, range of actual dose was 85-87.5 mg/m^2.
1238913|NCT00124657|E1|Reported Event|70 mg/m^2 (Phase I)|Participants received dose of 70 mg/m^2, range of actual dose was 68-83 mg/m^2.
1238914|NCT00124618|B1|Baseline|Cetuximab/Radiation|Cetuximab (C225) and Radiation therapy
1238915|NCT00124618|P1|Participant Flow|Cetuximab/Radiation|Cetuximab (C225) and Radiation therapy
1238916|NCT00124618|O1|Outcome|Cetuximab/Radiation|Cetuximab (C225) and Radiation therapy
1238917|NCT00124618|O1|Outcome|Cetuximab/Radiation|Cetuximab (C225) and Radiation therapy
1238918|NCT00124618|O1|Outcome|Cetuximab/Radiation|Cetuximab (C225) and Radiation therapy
1238919|NCT00124618|O1|Outcome|Cetuximab/Radiation|Cetuximab (C225) and Radiation therapy
1238920|NCT00124618|E1|Reported Event|Cetuximab/Radiation|Cetuximab (C225) and Radiation therapy
1238921|NCT00124579|B1|Baseline|Bortezomib With Thalidomide and Dexamethasone|"Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).~Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4."
1238922|NCT00124579|P1|Participant Flow|Bortezomib With Thalidomide and Dexamethasone Induction|"Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).~Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4."
1238923|NCT00124579|O1|Outcome|Bortezomib With Thalidomide and Dexamethasone|"Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).~Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4."
1238924|NCT00124579|O1|Outcome|Bortezomib With Thalidomide and Dexamethasone|"Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).~Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4."
1238925|NCT00124579|O1|Outcome|Bortezomib + Thal/Dex|"Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).~Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4."
1238926|NCT00124579|E1|Reported Event|Bortezomib + Thal/Dex|"Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).~Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4."
1238927|NCT00124449|B3|Baseline|Total|Total of all reporting groups
1238928|NCT00124449|B2|Baseline|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
1238929|NCT00124449|B1|Baseline|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
1250411|NCT00091793|O2|Outcome|Placebo|
1238935|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
1238936|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
1238937|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
1238938|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
1238939|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
1238940|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
1238941|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
1238942|NCT00124449|O1|Outcome|Abatacept|Abatacept by intravenous (IV) infusion, dose based on subject’s body weight at the screening visit
1238943|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
1238944|NCT00124449|O1|Outcome|Abatacept|Abatacept by intravenous (IV) infusion, dose based on subject’s body weight at the screening visit
1238945|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
1238946|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
1238947|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
1238948|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
1238949|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
1238950|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
1238951|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
1238952|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
1238953|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
1238954|NCT00124449|O1|Outcome|Abatacept|Abatacept by intravenous (IV) infusion, dose based on subject’s body weight at the screening visit
1238955|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
1251575|NCT00089661|O2|Outcome|Placebo|
1238956|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
1238957|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
1238958|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
1238959|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
1238960|NCT00124449|O1|Outcome|Abatacept|Abatacept by intravenous (IV) infusion, dose based on subject’s body weight at the screening visit
1238961|NCT00124449|E2|Reported Event|Placebo|
1238962|NCT00124449|E1|Reported Event|BMS-188667|
1238963|NCT00124176|B3|Baseline|Total|Total of all reporting groups
1238964|NCT00124176|B2|Baseline|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
1238965|NCT00124176|B1|Baseline|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
1238966|NCT00124176|P2|Participant Flow|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
1238967|NCT00124176|P1|Participant Flow|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
1238968|NCT00124176|O2|Outcome|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
1238969|NCT00124176|O1|Outcome|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
1238970|NCT00124176|O2|Outcome|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
1238971|NCT00124176|O1|Outcome|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
1238972|NCT00124176|O2|Outcome|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
1238973|NCT00124176|O1|Outcome|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
1238974|NCT00124176|O2|Outcome|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
1238975|NCT00124176|O1|Outcome|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
1238976|NCT00124176|O2|Outcome|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
1238977|NCT00124176|O1|Outcome|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
1238978|NCT00124176|E2|Reported Event|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
1238979|NCT00124176|E1|Reported Event|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
1238980|NCT00124072|B5|Baseline|Total|Total of all reporting groups
1238981|NCT00124072|B4|Baseline|Simvastatin 80 mg + Placebo|Participants received 80 mg simvastatin once daily, and placebo folic acid with placebo vitamin B12 once daily
1238982|NCT00124072|B3|Baseline|Simvastatin 20 mg + Placebo|Participants received 20 mg simvastatin once daily, and placebo folic acid with placebo vitamin B12 once daily
1238983|NCT00124072|B2|Baseline|Simvastatin 80 mg + Folic Acid and B12|Participants received 80 mg simvastatin once daily, and 2 mg folic acid with 1 mg vitamin B12 once daily
1238984|NCT00124072|B1|Baseline|Simvastatin 20 mg + Folic Acid and B12|Participants received 20 mg simvastatin once daily, and 2 mg folic acid with 1 mg vitamin B12 once daily
1238985|NCT00124072|P4|Participant Flow|Simvastatin 80 mg + Placebo|Participants received 80 mg simvastatin once daily, and placebo folic acid with placebo vitamin B12 once daily
1238986|NCT00124072|P3|Participant Flow|Simvastatin 20 mg + Placebo|Participants received 20 mg simvastatin once daily, and placebo folic acid with placebo vitamin B12 once daily
1238987|NCT00124072|P2|Participant Flow|Simvastatin 80 mg + Folic Acid and B12|Participants received 80 mg simvastatin once daily, and 2 mg folic acid with 1 mg vitamin B12 once daily
1238988|NCT00124072|P1|Participant Flow|Simvastatin 20 mg + Folic Acid and B12|Participants received 20 mg simvastatin once daily, and 2 mg folic acid with 1 mg vitamin B12 once daily
1238989|NCT00124072|O4|Outcome|Placebo|Placebo vitamin B12/folic acid tablet once daily in the following arms: simvastatin 20 mg daily + placebo vitamin B12/folic acid; simvastatin 80 mg daily + placebo vitamin B12/folic acid
1238990|NCT00124072|O3|Outcome|Folic Acid 2 mg + Vitamin B12 1 mg Daily|Folic acid 2 mg + vitamin B12 1 mg tablet once daily in the following arms: simvastatin 20 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active); simvastatin 80 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active)
1238991|NCT00124072|O2|Outcome|Simvastatin 80 mg Daily|Simvastatin 80 mg tablet once daily in the following arms: simvastatin 80 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active); simvastatin 80 mg daily + placebo vitamin B12/folic acid
1238992|NCT00124072|O1|Outcome|Simvastatin 20 mg Daily|Simvastatin 20 mg tablet once daily in the following arms: simvastatin 20 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active); simvastatin 20 mg daily + placebo vitamin B12/folic acid
1238993|NCT00124072|E4|Reported Event|Placebo|Placebo vitamin B12/folic acid tablet once daily in the following arms: simvastatin 20 mg daily + placebo vitamin B12/folic acid; simvastatin 80 mg daily + placebo vitamin B12/folic acid
1238994|NCT00124072|E3|Reported Event|Folic Acid 2 mg + Vitamin B12 1 mg Daily|Folic acid 2 mg + vitamin B12 1 mg tablet once daily in the following arms: simvastatin 20 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active); simvastatin 80 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active)
1238995|NCT00124072|E2|Reported Event|Simvastatin 80 mg Daily|Simvastatin 80 mg tablet once daily in the following arms: simvastatin 80 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active); simvastatin 80 mg daily + placebo vitamin B12/folic acid
1238996|NCT00124072|E1|Reported Event|Simvastatin 20 mg Daily|Simvastatin 20 mg tablet once daily in the following arms: simvastatin 20 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active); simvastatin 20 mg daily + placebo vitamin B12/folic acid
1238997|NCT00124020|B3|Baseline|Total|Total of all reporting groups
1240283|NCT00120406|O1|Outcome|Zilver PTX|Zilver® PTX™ Drug Eluting Vascular Stent
1238998|NCT00124020|B2|Baseline|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV every 12 hrs.
1238999|NCT00124020|B1|Baseline|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs
1239000|NCT00124020|P2|Participant Flow|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV every 12 hrs.
1239001|NCT00124020|P1|Participant Flow|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs
1239002|NCT00124020|O2|Outcome|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV every 12 hrs.
1239003|NCT00124020|O1|Outcome|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs
1239004|NCT00124020|E2|Reported Event|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV every 12 hrs.
1239005|NCT00124020|E1|Reported Event|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs
1239006|NCT00123955|B3|Baseline|Total|Total of all reporting groups
1239007|NCT00123955|B2|Baseline|Placebo|"Placebo~Placebo: Placebo tablet daily for 9 months"
1239008|NCT00123955|B1|Baseline|Spironolactone|"Spironolactone~Spironolactone: 25mg tablet daily for 9 months"
1239009|NCT00123955|P2|Participant Flow|Placebo|"Placebo~Placebo: Placebo tablet daily for 9 months"
1239010|NCT00123955|P1|Participant Flow|Spironolactone|"Spironolactone~Spironolactone: 25mg tablet daily for 9 months"
1239011|NCT00123955|O2|Outcome|Placebo|"Placebo~Placebo: Placebo tablet daily for 9 months"
1239012|NCT00123955|O1|Outcome|Spironolactone|"Spironolactone~Spironolactone: 25mg tablet daily for 9 months"
1239013|NCT00123955|E2|Reported Event|Placebo|"Placebo~Placebo: Placebo tablet daily for 9 months"
1239014|NCT00123955|E1|Reported Event|Spironolactone|"Spironolactone~Spironolactone: 25mg tablet daily for 9 months"
1239015|NCT00123734|B1|Baseline|Group 1|
1239016|NCT00123734|P1|Participant Flow|Group 1|
1239017|NCT00123734|O4|Outcome|15 Minute and 3 Hour Image Set|Review of whole leg 15 minute and 3 hour images in combination
1239018|NCT00123734|O3|Outcome|15 Min and 1 Hour Image Set|Review of whole leg 15 minute and 1 hour images in combination
1239019|NCT00123734|O2|Outcome|3 Hour Image Set|Review of 3 hour whole leg images
1239020|NCT00123734|O1|Outcome|1 Hour Image Set|Review of whole leg 1 hour images
1239021|NCT00123734|O4|Outcome|15 Minute and 3 Hour Image Set|Review of whole leg 15 minute and 3 hour images in combination
1239022|NCT00123734|O3|Outcome|15 Min and 1 Hour Image Set|Review of whole leg 15 minute and 1 hour images in combination
1239023|NCT00123734|O2|Outcome|3 Hour Image Set|Review of 3 hour whole leg images
1239024|NCT00123734|O1|Outcome|1 Hour Image Set|Review of whole leg 1 hour images
1239025|NCT00123734|O4|Outcome|15 Minute and 3 Hour Image Set|Review of whole leg 15 minute and 3 hour images in combination
1239026|NCT00123734|O3|Outcome|15 Min and 1 Hour Image Set|Review of whole leg 15 minute and 1 hour images in combination
1239027|NCT00123734|O2|Outcome|3 Hour Image Set|Review of 3 hour whole leg images
1239028|NCT00123734|O1|Outcome|1 Hour Image Set|Review of whole leg 1 hour images
1239029|NCT00123734|O4|Outcome|15 Minute and 3 Hour Image Set|Review of whole leg 15 minute and 3 hour images in combination
1239030|NCT00123734|O3|Outcome|15 Min and 1 Hour Image Set|Review of whole leg 15 minute and 1 hour images in combination
1239031|NCT00123734|O2|Outcome|3 Hour Image Set|Review of 3 hour whole leg images
1239032|NCT00123734|O1|Outcome|1 Hour Image Set|Review of whole leg 1 hour images
1239033|NCT00123734|O4|Outcome|15 Minute and 3 Hour Image Set|Review of whole leg 15 minute and 3 hour images in combination
1239034|NCT00123734|O3|Outcome|15 Min and 1 Hour Image Set|Review of whole leg 15 minute and 1 hour images in combination
1239035|NCT00123734|O2|Outcome|3 Hour Image Set|Review of 3 hour whole leg images
1239036|NCT00123734|O1|Outcome|1 Hour Image Set|Review of whole leg 1 hour images
1239037|NCT00123734|O4|Outcome|15 Minute and 3 Hour Image Set|Review of whole leg 15 minute and 3 hour images in combination
1239038|NCT00123734|O3|Outcome|15 Min and 1 Hour Image Set|Review of whole leg 15 minute and 1 hour images in combination
1239039|NCT00123734|O2|Outcome|3 Hour Image Set|Review of 3 hour whole leg images
1239040|NCT00123734|O1|Outcome|1 Hour Image Set|Review of whole leg 1 hour images
1239041|NCT00123734|O4|Outcome|15 Minute and 3 Hour Image Set|Review of whole leg 15 minute and 3 hour images in combination
1239042|NCT00123734|O3|Outcome|15 Min and 1 Hour Image Set|Review of whole leg 15 minute and 1 hour images in combination
1239043|NCT00123734|O2|Outcome|3 Hour Image Set|Review of 3 hour whole leg images
1239044|NCT00123734|O1|Outcome|1 Hour Image Set|Review of whole leg 1 hour images
1239045|NCT00123734|E1|Reported Event|Group 1|
1239046|NCT00123682|B5|Baseline|Total|Total of all reporting groups
1239047|NCT00123682|B4|Baseline|Reactive Referral and Self-help Materials|Reactive referral and self-help materials
1239048|NCT00123682|B3|Baseline|Proactive Referral and Self-help Materials|Proactive referral and self-help materials
1239049|NCT00123682|B2|Baseline|Reactive Referral and Intensive Counseling|Reactive referral and intensive counseling
1239050|NCT00123682|B1|Baseline|Proactive Referral and Intensive Telephone Counseling|Proactive referral and intensive telephone counseling
1239051|NCT00123682|P4|Participant Flow|Reactive Referral and Self-help Materials|Reactive referral and self-help materials
1239052|NCT00123682|P3|Participant Flow|Proactive Referral and Self-help Materials|Proactive referral and self-help materials
1239053|NCT00123682|P2|Participant Flow|Reactive Referral and Intensive Counseling|Reactive referral and intensive counseling
1239054|NCT00123682|P1|Participant Flow|Proactive Referral and Intensive Telephone Counseling|Proactive referral and intensive telephone counseling
1239055|NCT00123682|O4|Outcome|Reactive Referral and Self-help Materials|Reactive referral and self-help materials
1239056|NCT00123682|O3|Outcome|Proactive Referral and Self-help Materials|Proactive referral and self-help materials
1239057|NCT00123682|O2|Outcome|Reactive Referral and Intensive Counseling|Reactive referral and intensive counseling
1239058|NCT00123682|O1|Outcome|Proactive Referral and Intensive Telephone Counseling|Proactive referral and intensive telephone counseling
1239059|NCT00123682|O4|Outcome|Reactive Referral and Self-help Materials|Reactive referral and self-help materials
1239060|NCT00123682|O3|Outcome|Proactive Referral and Self-help Materials|Proactive referral and self-help materials
1239061|NCT00123682|O2|Outcome|Reactive Referral and Intensive Counseling|Reactive referral and intensive counseling
1239062|NCT00123682|O1|Outcome|Proactive Referral and Intensive Telephone Counseling|Proactive referral and intensive telephone counseling
1239063|NCT00123682|O4|Outcome|Reactive Referral and Self-help Materials|
1239064|NCT00123682|O3|Outcome|Proactive Referral and Self-help Materials|
1239065|NCT00123682|O2|Outcome|Reactive Referral and Intensive Counseling|
1239066|NCT00123682|O1|Outcome|Proactive Referral and Intensive Telephone Counseling|
1239067|NCT00123682|E4|Reported Event|Reactive Referral and Self-help Materials|
1239068|NCT00123682|E3|Reported Event|Proactive Referral and Self-help Materials|
1239069|NCT00123682|E2|Reported Event|Reactive Referral and Intensive Counseling|
1239070|NCT00123682|E1|Reported Event|Proactive Referral and Intensive Telephone Counseling|
1239071|NCT00123643|B3|Baseline|Total|Total of all reporting groups
1239072|NCT00123643|B2|Baseline|Glyburide|
1239073|NCT00123643|B1|Baseline|Rosiglitazone|
1239074|NCT00123643|P2|Participant Flow|Glyburide|
1239075|NCT00123643|P1|Participant Flow|Rosiglitazone|
1239076|NCT00123643|O2|Outcome|Glyburide|
1239077|NCT00123643|O1|Outcome|Rosiglitazone|
1239078|NCT00123643|E2|Reported Event|Glyburide|
1239079|NCT00123643|E1|Reported Event|Rosiglitazone|
1239080|NCT00123630|B3|Baseline|Total|Total of all reporting groups
1239081|NCT00123630|B2|Baseline|Omalizumab|Xolair (Omalizumab)150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
1239082|NCT00123630|B1|Baseline|Placebo|Placebo 150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
1239083|NCT00123630|P2|Participant Flow|Omalizumab|Xolair (Omalizumab)150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
1239084|NCT00123630|P1|Participant Flow|Placebo|Placebo 150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
1239085|NCT00123630|O2|Outcome|Omalizumab|Xolair (Omalizumab)150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
1239240|NCT00123422|B3|Baseline|Exercise|"Exercise training~Exercise: exercise training"
1240105|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
1239086|NCT00123630|O1|Outcome|Placebo|Placebo 150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
1239087|NCT00123630|E2|Reported Event|Omalizumab|Xolair (Omalizumab)150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
1239088|NCT00123630|E1|Reported Event|Placebo|Placebo 150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
1239089|NCT00123604|B3|Baseline|Total|Total of all reporting groups
1239090|NCT00123604|B2|Baseline|Carvedilol|Carvedilol, orally, 25mg, twice daily for five months
1239091|NCT00123604|B1|Baseline|Metoprolol|Metoprolol, orally, 200mg, twice daily for five months
1239092|NCT00123604|P2|Participant Flow|Carvedilol|Carvedilol, orally, 25 mg, once daily
1239093|NCT00123604|P1|Participant Flow|Metoprolol|Metoprolol, orally, 200 mg, once daily
1239094|NCT00123604|O2|Outcome|Metoprolol|Metoprolol, orally, 200mg, once daily
1239095|NCT00123604|O1|Outcome|Carvedilol|Carvedilol, orally, 25mg, once daily
1239096|NCT00123604|E2|Reported Event|Carvedilol|Carvedilol, orally, 25 mg, once daily
1239097|NCT00123604|E1|Reported Event|Metoprolol|Metoprolol, orally, 200mg, once daily
1239098|NCT00123487|B3|Baseline|Total|Total of all reporting groups
1239099|NCT00123487|B2|Baseline|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
1239100|NCT00123487|B1|Baseline|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
1239101|NCT00123487|P2|Participant Flow|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
1239265|NCT00123409|E1|Reported Event|Arm 1|"Telephone Based care management for reducing alcohol use~Telephone disease management: Telephone based care management"
1239266|NCT00123162|B3|Baseline|Total|Total of all reporting groups
1239102|NCT00123487|P1|Participant Flow|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
1239103|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
1239104|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
1239105|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
1239106|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
1239107|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
1239108|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
1239109|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
1239110|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
1239111|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
1239112|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
1239113|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
1239114|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
1239115|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
1239116|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
1239428|NCT00122447|P2|Participant Flow|Olmesartan (ARB) 40 mg PO Once Daily|Angiotensin receptor blocker (ARB)
1239117|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
1239118|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
1239119|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
1239120|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
1239121|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
1239122|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
1239123|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
1239124|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
1239125|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
1239126|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
1239127|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
1239267|NCT00123162|B2|Baseline|Placebo|A single vaginal dose of placebo.
1239268|NCT00123162|B1|Baseline|Sildenafil Citrate|A single vaginal dose of sildenafil citrate 100 mg.
1239128|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
1239129|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
1239130|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
1239131|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
1239132|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
1239133|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
1239134|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
1239135|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
1239136|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
1239137|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
1239138|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
1239139|NCT00123487|E2|Reported Event|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
1239140|NCT00123487|E1|Reported Event|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
1239141|NCT00123474|B5|Baseline|Total|Total of all reporting groups
1239142|NCT00123474|B4|Baseline|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239429|NCT00122447|P1|Participant Flow|Aspirin (ASA) 325 mg PO Once Daily|Anti-inflammatory agent
1239143|NCT00123474|B3|Baseline|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239144|NCT00123474|B2|Baseline|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
1239145|NCT00123474|B1|Baseline|Dasatinib 100 mg QD|Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
1239146|NCT00123474|P4|Participant Flow|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239147|NCT00123474|P3|Participant Flow|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239148|NCT00123474|P2|Participant Flow|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
1239149|NCT00123474|P1|Participant Flow|Dasatinib 100 mg QD|Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
1239150|NCT00123474|O3|Outcome|Total|Participants received study drug in any schedule or total daily dose until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
1239151|NCT00123474|O2|Outcome|Other Treatment Groups|Participants participated in all other treatment arms until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
1239152|NCT00123474|O1|Outcome|100 mg QD|Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
1239153|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239154|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239269|NCT00123162|P2|Participant Flow|Placebo|A single vaginal dose of placebo.
1239155|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239156|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
1239157|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239158|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239159|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239160|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
1239161|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239162|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239163|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239164|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
1239165|NCT00123474|O4|Outcome|Total Daily Dose 140 mg|Participants received either 140 mg QD or 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
1239166|NCT00123474|O3|Outcome|Total Daily Dose 100 mg|Participants received either 100 mg QD or 50 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
1240106|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE
1239167|NCT00123474|O2|Outcome|BID Dasatinib|Participants received either 50 mg or 70 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
1239168|NCT00123474|O1|Outcome|QD Dasatinib|Participants received either 100 mg or 140 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
1239169|NCT00123474|O4|Outcome|Total Daily Dose 140 mg|Participants received either 140 mg QD or 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
1239170|NCT00123474|O3|Outcome|Total Daily Dose 100 mg|Participants received either 100 mg QD or 50 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
1239171|NCT00123474|O2|Outcome|BID Dasatinib|Participants received either 50 mg or 70 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
1239172|NCT00123474|O1|Outcome|QD Dasatinib|Participants received either 100 mg or 140 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
1239173|NCT00123474|O4|Outcome|70mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
1239174|NCT00123474|O3|Outcome|50mg BID|Participants received 50 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
1239175|NCT00123474|O2|Outcome|140mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
1239176|NCT00123474|O1|Outcome|100mg QD|"Participants received 100 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
1239177|NCT00123474|O4|Outcome|70mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
1239178|NCT00123474|O3|Outcome|50mg BID|Participants received 50 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
1239179|NCT00123474|O2|Outcome|140mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
1239270|NCT00123162|P1|Participant Flow|Sildenafil Citrate|A single vaginal dose of sildenafil citrate 100 mg.
1239180|NCT00123474|O1|Outcome|100mg QD|"Participants received 100 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
1239181|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239182|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239183|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239184|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
1239185|NCT00123474|O4|Outcome|Total Daily Dose 140 mg|Participants received either 140 mg QD or 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
1239186|NCT00123474|O3|Outcome|Total Daily Dose 100 mg|Participants received either 100 mg QD or 50 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
1239187|NCT00123474|O2|Outcome|BID Dasatinib|Participants received either 50 mg or 70 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
1239188|NCT00123474|O1|Outcome|QD Dasatinib|Participants received either 100 mg or 140 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
1239189|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239190|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239191|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
1239192|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
1239241|NCT00123422|B2|Baseline|Heliox|"Exercise training with helium oxygen combination~Heliox: exercise training with a helium oxygen combination"
1239193|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239194|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239195|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
1239196|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
1239197|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239198|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239199|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239200|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
1239201|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239202|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239203|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239271|NCT00123162|O2|Outcome|Placebo|A single vaginal dose of placebo.
1239204|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
1239205|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239206|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239207|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239208|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
1239209|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239210|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239211|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239212|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
1239213|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239214|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239215|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239216|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
1239217|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239218|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239219|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
1239220|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
1239221|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239222|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239223|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239224|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
1239225|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239272|NCT00123162|O1|Outcome|Sildenafil Citrate|A single vaginal dose of sildenafil citrate 100 mg.
1239226|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239227|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239228|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
1239229|NCT00123474|O4|Outcome|Dasatinib 140 mg Total Daily Dose|Participants received 140 mg as a total daily dose (either 70 mg BID or 140 mg QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
1239230|NCT00123474|O3|Outcome|Dasatinib 100 mg Total Daily Dose|Participants received 100 mg as a total daily dose (either 50 mg BID or 100 mg QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
1239231|NCT00123474|O2|Outcome|Dasatinib BID|Participants received either 50 mg BID or 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
1239232|NCT00123474|O1|Outcome|Dasatinib QD|Participants received either 100 mg QD or 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
1239233|NCT00123474|O2|Outcome|BID Dasatinib|Participants received either 50 mg or 70 mg twice a day (BID) dasatinib until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
1239234|NCT00123474|O1|Outcome|QD Dasatinib|Participants received either 100 mg or 140 mg once a day (QD) dasatinib until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
1239235|NCT00123474|E4|Reported Event|70mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
1239236|NCT00123474|E3|Reported Event|50mg BID|Participants received 50 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
1239237|NCT00123474|E2|Reported Event|140mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
1239238|NCT00123474|E1|Reported Event|100mg QD|"Participants received 100 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
1239242|NCT00123422|B1|Baseline|Breathing Retraining|"Exercise training with computerized training program~Breathing retraining: exercise training with computerized training program"
1239243|NCT00123422|P3|Participant Flow|Exercise|"Exercise training~Exercise: exercise training"
1239244|NCT00123422|P2|Participant Flow|Heliox|"Exercise training with helium oxygen combination~Heliox: exercise training with a helium oxygen combination"
1239245|NCT00123422|P1|Participant Flow|Breathing Retraining|"Exercise training with computerized training program~Breathing retraining: exercise training with computerized training program"
1239246|NCT00123422|O3|Outcome|Exercise|"Exercise training~Exercise: exercise training"
1239247|NCT00123422|O2|Outcome|Heliox|"Exercise training with helium oxygen combination~Heliox: exercise training with a helium oxygen combination"
1239248|NCT00123422|O1|Outcome|Breathing Retraining|"Exercise training with computerized training program~Breathing retraining: exercise training with computerized training program"
1239249|NCT00123422|O3|Outcome|Exercise|"Exercise training~Exercise: exercise training"
1239250|NCT00123422|O2|Outcome|Heliox|"Exercise training with helium oxygen combination~Heliox: exercise training with a helium oxygen combination"
1239251|NCT00123422|O1|Outcome|Breathing Retraining|"Exercise training with computerized training program~Breathing retraining: exercise training with computerized training program"
1239252|NCT00123422|E3|Reported Event|Exercise|"Exercise training~Exercise: exercise training"
1239253|NCT00123422|E2|Reported Event|Heliox|"Exercise training with helium oxygen combination~Heliox: exercise training with a helium oxygen combination"
1239254|NCT00123422|E1|Reported Event|Breathing Retraining|"Exercise training with computerized training program~Breathing retraining: exercise training with computerized training program"
1239255|NCT00123409|B3|Baseline|Total|Total of all reporting groups
1239256|NCT00123409|B2|Baseline|Usual Care|"Usual Care~Usual Care: Usual care"
1239257|NCT00123409|B1|Baseline|Telephone Disease Management|"Telephone Based care management for reducing alcohol use~Telephone disease management: Telephone based care management"
1239258|NCT00123409|P2|Participant Flow|Arm 2|"Usual Care~Usual Care: Usual care"
1239259|NCT00123409|P1|Participant Flow|Arm 1|"Telephone Based care management for reducing alcohol use~Telephone disease management: Telephone based care management"
1239260|NCT00123409|O2|Outcome|Arm 2|"Usual Care~Usual Care: Usual care"
1239261|NCT00123409|O1|Outcome|Arm 1|"Telephone Based care management for reducing alcohol use~Telephone disease management: Telephone based care management"
1239262|NCT00123409|O2|Outcome|Usual Care|"Usual Care~Usual Care: Usual care"
1239263|NCT00123409|O1|Outcome|Telephone Based Management|"Telephone Based Management used to reduce alcohol misuse~Telephone disease management: Telephone based care management"
1239273|NCT00123162|O2|Outcome|Placebo|A single vaginal dose of placebo.
1239276|NCT00123162|E1|Reported Event|Sildenafil Citrate|A single vaginal dose of sildenafil citrate 100 mg.
1239277|NCT00123123|B4|Baseline|Total|Total of all reporting groups
1239278|NCT00123123|B3|Baseline|Chlorhexidine|chlorhexidine 1 oz oral rinse twice a day
1239279|NCT00123123|B2|Baseline|Chlorhexidine/Placebo|Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day
1239280|NCT00123123|B1|Baseline|Placebo|Vehicle control twice a day (oral rinse)
1239281|NCT00123123|P3|Participant Flow|Chlorhexidine|chlorhexidine 1 oz oral rinse twice a day
1239282|NCT00123123|P2|Participant Flow|Chlorhexidine/Placebo|Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day
1239283|NCT00123123|P1|Participant Flow|Placebo|Vehicle control twice a day (oral rinse)
1239284|NCT00123123|O3|Outcome|Chlorhexidine|chlorhexidine 1 oz oral rinse twice a day
1239285|NCT00123123|O2|Outcome|Chlorhexidine/Placebo|Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day
1239286|NCT00123123|O1|Outcome|Placebo|Vehicle control twice a day (oral rinse)
1239287|NCT00123123|O3|Outcome|Chlorhexidine|chlorhexidine 1 oz oral rinse twice a day
1239288|NCT00123123|O2|Outcome|Chlorhexidine/Placebo|Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day
1239289|NCT00123123|O1|Outcome|Placebo|Vehicle control twice a day (oral rinse)
1239290|NCT00123123|E3|Reported Event|Chlorhexidine|chlorhexidine 1 oz oral rinse twice a day
1239291|NCT00123123|E2|Reported Event|Chlorhexidine/Placebo|Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day
1239292|NCT00123123|E1|Reported Event|Placebo|Vehicle control twice a day (oral rinse)
1239293|NCT00122980|B3|Baseline|Total|Total of all reporting groups
1239294|NCT00122980|B2|Baseline|Transfusion/Chelation|2: The Transfusion/Chelation group includes participants randomized to Standard Treatment. Participants continued to receive monthly blood transfusions designed to maintain ≤30% HbS, with local discretion regarding type of transfusion (e.g., simple or erythrocytapheresis). These participants also received daily iron chelation typically with deferasirox (Exjade®). Children already on chelation initially maintained their current dose, while those starting deferasirox received 20 mg/kg/day, with dose escalation in both groups as indicated and tolerated.
1239295|NCT00122980|B1|Baseline|Hydroxyurea/Phlebotomy|1: The Hydroxyurea/Phlebotomy group includes participants randomized to Alternative Treatment. Participants commenced hydroxyurea treatment at 20 mg/kg/day with step-wise escalation to maximum tolerated dose (MTD) defined by mild myelosuppression (absolute neutrophil count 2-4 x 10^9/L). Transfusions continued for 4-9 months during an overlap phase using a modified schedule to protect against recurrent stroke during hydroxyurea dose escalation. Once MTD was reached and transfusions were discontinued, phlebotomy commenced with a target of 10 mL/kg (maximum volume 500mL) blood removed monthly to reduce iron burden. Lower phlebotomy volumes (5 mL/kg) were recommended if participants were excessively anemic (hemoglobin concentration 7.0-7.9 gm/dL); phlebotomy was not performed if the hemoglobin level was <7.0 gm/dL. The total duration of study treatment was 30 months after randomization, with a final study visit scheduled 6-months after discontinuation of study treatments.
1239334|NCT00122681|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239335|NCT00122681|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239430|NCT00122447|O3|Outcome|Diabetes|"After 75g OGTT:~Fasting glucose >=126 mg/dl and 2-hr glucose level >=200 mg/dl"
1239296|NCT00122980|P2|Participant Flow|Transfusion/Chelation|2: The Transfusion/Chelation group includes participants randomized to Standard Treatment. Participants continued to receive monthly blood transfusions designed to maintain ≤30% HbS, with local discretion regarding type of transfusion (e.g., simple or erythrocytapheresis). These participants also received daily iron chelation typically with deferasirox (Exjade®). Children already on chelation initially maintained their current dose, while those starting deferasirox received 20 mg/kg/day, with dose escalation in both groups as indicated and tolerated.
1239297|NCT00122980|P1|Participant Flow|Hydroxyurea/Phlebotomy|1: The Hydroxyurea/Phlebotomy group includes participants randomized to Alternative Treatment. Participants commenced hydroxyurea treatment at 20 mg/kg/day with step-wise escalation to maximum tolerated dose (MTD) defined by mild myelosuppression (absolute neutrophil count 2-4 x 10^9/L). Transfusions continued for 4-9 months during an overlap phase using a modified schedule to protect against recurrent stroke during hydroxyurea dose escalation. Once MTD was reached and transfusions were discontinued, phlebotomy commenced with a target of 10 mL/kg (maximum volume 500mL) blood removed monthly to reduce iron burden. Lower phlebotomy volumes (5 mL/kg) were recommended if participants were excessively anemic (hemoglobin concentration 7.0-7.9 gm/dL); phlebotomy was not performed if the hemoglobin level was <7.0 gm/dL. The total duration of study treatment was 30 months after randomization, with a final study visit scheduled 6-months after discontinuation of study treatments.
1239298|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
1239299|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
1239300|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
1239301|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
1239302|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
1239303|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
1239304|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
1239305|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
1239306|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
1239307|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
1239308|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
1239309|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
1239310|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
1239311|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
1239312|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
1239313|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
1239314|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
1251576|NCT00089661|O1|Outcome|Denosumab 60 mg Q6M|
1239315|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
1239316|NCT00122980|E2|Reported Event|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
1239317|NCT00122980|E1|Reported Event|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
1239318|NCT00122954|B3|Baseline|Total|Total of all reporting groups
1239319|NCT00122954|B2|Baseline|Fish Oil Concentrate|Participants receiving fish oil concentrate at a daily dose of 6 grams (2.1 grams EPA and 1.5 grams DHA)
1239320|NCT00122954|B1|Baseline|Placebo|Participants receiving soybean placebo with 1% fish oil at a daily dose of 6 grams.
1239321|NCT00122954|P2|Participant Flow|Omega-3 Fatty Acids|Participants randomized to the omega-3 FA group received capsules in the form of fish oil concentrate (triglyceride form) at a daily dose of 6 grams (1.95 grams of EPA and 1.45 grams of DHA).
1239322|NCT00122954|P1|Participant Flow|Placebo|Participants randomized to the placebo group received capsules that contained soybean oil with 1% fish oil so that it was flavored to taste and smell similar to the fish oil capsules.
1239323|NCT00122954|O2|Outcome|Omega-3 Fatty Acids|Participants randomized to the omega-3 FA group received capsules in the form of fish oil concentrate (triglyceride form) at a daily dose of 6 grams (1.95 grams of EPA and 1.45 grams of DHA).
1239324|NCT00122954|O1|Outcome|Placebo|Participants randomized to the placebo group received capsules that contained soybean oil with 1% fish oil so that it was flavored to taste and smell similar to the fish oil capsules.
1239325|NCT00122954|O2|Outcome|Omega-3 Fatty Acids|Participants randomized to the omega-3 FA group received capsules in the form of fish oil concentrate (triglyceride form) at a daily dose of 6 grams (1.95 grams of EPA and 1.45 grams of DHA).
1239326|NCT00122954|O1|Outcome|Placebo|Participants randomized to the placebo group received capsules that contained soybean oil with 1% fish oil so that it was flavored to taste and smell similar to the fish oil capsules.
1239327|NCT00122954|E2|Reported Event|Omega-3 Fatty Acids|Participants randomized to the omega-3 FA group received capsules in the form of fish oil concentrate (triglyceride form) at a daily dose of 6 grams (1.95 grams of EPA and 1.45 grams of DHA).
1239328|NCT00122954|E1|Reported Event|Placebo|Participants randomized to the placebo group received capsules that contained soybean oil with 1% fish oil so that it was flavored to taste and smell similar to the fish oil capsules.
1239329|NCT00122681|B3|Baseline|Total|Total of all reporting groups
1239330|NCT00122681|B2|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239331|NCT00122681|B1|Baseline|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
1239332|NCT00122681|P2|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239333|NCT00122681|P1|Participant Flow|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
1239336|NCT00122681|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239337|NCT00122681|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239338|NCT00122681|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239339|NCT00122681|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239340|NCT00122681|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239341|NCT00122681|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239342|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239343|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
1239344|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239345|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
1239346|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239347|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
1239348|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239349|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
1239350|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239351|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
1239352|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239353|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
1239354|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1240284|NCT00120406|E2|Reported Event|PTA (Control)|Percutaneous balloon angioplasty
1239355|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
1239356|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239357|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
1239358|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239359|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
1239360|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239361|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
1239362|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239363|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
1239364|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239365|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
1239366|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239367|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
1239368|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239369|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
1239370|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239371|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
1239372|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239373|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
1239374|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239375|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
1250412|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
1239376|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239377|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
1239378|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239379|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
1239380|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239381|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
1239382|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239383|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
1239384|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239385|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
1239386|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239387|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
1239388|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239389|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
1239390|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239391|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
1239392|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1239393|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
1239394|NCT00122681|E2|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
1240285|NCT00120406|E1|Reported Event|Zilver PTX|Zilver® PTX™ Drug Eluting Vascular Stent
1239395|NCT00122681|E1|Reported Event|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
1239396|NCT00122460|B3|Baseline|Total|Total of all reporting groups
1239397|NCT00122460|B2|Baseline|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
1239398|NCT00122460|B1|Baseline|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
1239399|NCT00122460|P2|Participant Flow|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
1239400|NCT00122460|P1|Participant Flow|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
1239401|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
1239402|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
1239403|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
1239404|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
1239405|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
1239406|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
1239407|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
1239408|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
1239409|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
1239410|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
1239411|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
1239412|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
1239413|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
1239488|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
1239414|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
1239415|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
1239416|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
1239417|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
1239418|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
1239419|NCT00122460|E2|Reported Event|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
1239420|NCT00122460|E1|Reported Event|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
1239421|NCT00122447|B5|Baseline|Total|Total of all reporting groups
1239422|NCT00122447|B4|Baseline|Placebo|Aspirin placebo PO once a day Olmesartan placebo PO once a day Alpha lipoic acid placebo PO twice a day
1239423|NCT00122447|B3|Baseline|Alpha Lipoic Acid (ALA) 600 mg PO Twice Daily|Antioxidant
1239424|NCT00122447|B2|Baseline|Olmesartan (ARB) 40 mg PO Once Daily|Angiotensin receptor blocker (ARB)
1239425|NCT00122447|B1|Baseline|Aspirin (ASA) 325 mg PO Once Daily|Anti-inflammatory agent
1239426|NCT00122447|P4|Participant Flow|Placebo|Aspirin placebo PO once a day Olmesartan placebo PO once a day Alpha lipoic acid placebo PO twice a day
1239427|NCT00122447|P3|Participant Flow|Alpha Lipoic Acid (ALA) 600 mg PO Twice Daily|Antioxidant
1250413|NCT00091793|E2|Reported Event|Denosumab 60 mg Q6M|
1239431|NCT00122447|O2|Outcome|Impaired Glucose Tolerance (IGT)|"After 75g OGTT:~Fasting glucose <126 mg/dl and 2-hr glucose level 140-199 mg/dl"
1239432|NCT00122447|O1|Outcome|Normal Glucose Tolerance (NGT)|Normal fasting glucose (<100 mg/dl) and normal 2-hr glucose level (<140 mg/dl) after 75g OGTT
1239433|NCT00122447|O4|Outcome|Placebo|Aspirin placebo PO once a day Olmesartan placebo PO once a day Alpha lipoic acid placebo PO twice a day
1239434|NCT00122447|O3|Outcome|Alpha Lipoic Acid (ALA) 600 mg PO Twice Daily|Antioxidant
1239435|NCT00122447|O2|Outcome|Olmesartan (ARB) 40 mg PO Once Daily|Angiotensin receptor blocker (ARB)
1239436|NCT00122447|O1|Outcome|Aspirin (ASA) 325 mg PO Once Daily|Anti-inflammatory agent
1239437|NCT00122447|O4|Outcome|Placebo|Aspirin placebo PO once a day Olmesartan placebo PO once a day Alpha lipoic acid placebo PO twice a day
1239438|NCT00122447|O3|Outcome|Alpha Lipoic Acid (ALA) 600 mg PO Twice Daily|Antioxidant
1239439|NCT00122447|O2|Outcome|Olmesartan (ARB) 40 mg PO Once Daily|Angiotensin receptor blocker (ARB)
1239440|NCT00122447|O1|Outcome|Aspirin (ASA) 325 mg PO Once Daily|Anti-inflammatory agent
1239441|NCT00122447|E5|Reported Event|Enrolled, But Not Yet Randomized|Enrolled into study, but not yet randomized to study medication
1239442|NCT00122447|E4|Reported Event|Placebo|Aspirin placebo once a day Olmesartan placebo once a day Alpha lipoic acid placebo twice a day
1239443|NCT00122447|E3|Reported Event|Alpha Lipoic Acid|Antioxidant
1239444|NCT00122447|E2|Reported Event|Olmesartan|Angiotensin receptor blocker (ARB)
1239445|NCT00122447|E1|Reported Event|Aspirin|Anti-inflammatory agent
1239446|NCT00122382|B3|Baseline|Total|Total of all reporting groups
1239447|NCT00122382|B2|Baseline|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
1239448|NCT00122382|B1|Baseline|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
1239449|NCT00122382|P3|Participant Flow|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with weekly oral MTX were administered every 28 days from Month 12 to Month 24 (open-label period).
1239611|NCT00122187|E2|Reported Event|Usual Care|The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
1239450|NCT00122382|P2|Participant Flow|Placebo (PLA) + Methotrexate (MTX) (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX) titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12 (end of double blind period).
1239451|NCT00122382|P1|Participant Flow|Abatacept (ABA) + Methotrexate (MTX) (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12 (end of double blind period).
1239452|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
1239453|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
1239454|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
1239455|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
1239456|NCT00122382|O2|Outcome|Year 2 Change|Year 2 Change = Day 729 (Month 24) - Day 365 (Month 12)
1239457|NCT00122382|O1|Outcome|Year 1 Change|Year 1 Change = Day 365 - Day 1
1239458|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
1239459|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
1239460|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period). The groups are determined by treatment status in the double blind period to observe efficacy differences.
1239461|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period). The groups are determined by treatment status in the double blind period to observe efficacy differences.
1240107|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
1239462|NCT00122382|O1|Outcome|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
1239463|NCT00122382|O1|Outcome|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
1239464|NCT00122382|O1|Outcome|ABA + MTX (Open-label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
1239465|NCT00122382|O2|Outcome|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
1239466|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
1239467|NCT00122382|O2|Outcome|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
1239468|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
1239612|NCT00122187|E1|Reported Event|Electronic Consult System|A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
1239469|NCT00122382|O2|Outcome|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
1239470|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
1239471|NCT00122382|O1|Outcome|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
1239472|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period). The groups are determined by treatment status in the double blind period to observe efficacy differences.
1239473|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period). The groups are determined by treatment status in the double blind period to observe efficacy differences.
1239474|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period). The groups are determined by treatment status in the double blind period to observe efficacy differences.
1239475|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period). The groups are determined by treatment status in the double blind period to observe efficacy differences.
1239476|NCT00122382|O2|Outcome|Anti-CTLA4-T Antibody Response|
1239477|NCT00122382|O1|Outcome|Anti-Abatacept Antibody Response|
1240108|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE
1239478|NCT00122382|O1|Outcome|ABA + MTX (Open Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
1239479|NCT00122382|O1|Outcome|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
1239480|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
1239481|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
1239482|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
1239483|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
1239484|NCT00122382|O2|Outcome|ABA + MTX Post-discontinuation|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
1239485|NCT00122382|O1|Outcome|ABA+ MTX On-treatment|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
1239486|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
1239487|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
1239489|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
1239490|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
1239491|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
1239492|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
1239493|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
1239494|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
1239495|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
1239496|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
1239497|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
1239498|NCT00122382|E2|Reported Event|Placebo|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
1239499|NCT00122382|E1|Reported Event|Abatacept|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
1239500|NCT00122369|B4|Baseline|Total|Total of all reporting groups
1239501|NCT00122369|B3|Baseline|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient’s anxiety, pain, or worries according to the prescriptions of the script.
1250414|NCT00091793|E1|Reported Event|Placebo|
1239502|NCT00122369|B2|Baseline|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
1239503|NCT00122369|B1|Baseline|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
1239504|NCT00122369|P3|Participant Flow|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
1239505|NCT00122369|P2|Participant Flow|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
1239506|NCT00122369|P1|Participant Flow|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
1239507|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
1239508|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
1239509|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
1239510|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
1239511|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
1239512|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
1239513|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
1239514|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
1239515|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
1239516|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
1239517|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
1239518|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
1239519|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
1239520|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
1239521|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
1239522|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
1239523|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
1239524|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
1239525|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
1239526|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
1239527|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
1239528|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
1239529|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
1239530|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
1239531|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
1239532|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
1239533|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
1239534|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
1239613|NCT00122135|B3|Baseline|Total|Total of all reporting groups
1239614|NCT00122135|B2|Baseline|Patients Without VI|Patients who did not receive the Values History prior to their clinic appointment (usual care)
1251577|NCT00089661|O2|Outcome|Placebo|
1239535|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
1239536|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
1239537|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
1239538|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
1239539|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
1239540|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
1239541|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
1239542|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
1239543|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
1239544|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
1239545|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
1239546|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
1239547|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
1239548|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
1239549|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
1239550|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
1239551|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
1239552|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
1239553|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
1239554|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
1239555|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
1239556|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
1239557|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
1239558|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
1239559|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
1239560|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
1239561|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
1239562|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
1239563|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
1239564|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
1239565|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
1239566|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
1239567|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
1239568|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
1239569|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
1239570|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
1239571|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
1239572|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
1239573|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
1239574|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
1239575|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
1239576|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
1239577|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
1239578|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
1239579|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
1239615|NCT00122135|B1|Baseline|Patients With VI|Patients who filled out the Values History prior to their clinic appointment
1239616|NCT00122135|P2|Participant Flow|Patients Without VI|Patients who did not receive the Values Inventory prior to their clinic visit
1239580|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
1239581|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
1239582|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
1239583|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
1239584|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
1239585|NCT00122369|O3|Outcome|Uncertain Diagnosis|"were in the uncertain diagnostic group, either because their result had not been communicated yet (n=54); their LCBB could not be performed for technical reasons and they were waiting for a surgical excision (n=14); or histology showed at risk lesions (n=4) or benign cells with surgery recommended for excision and final diagnosis (n=1)."
1239586|NCT00122369|O2|Outcome|Known Malignant Disease|Women who were diagnosed to have malignant disease
1239587|NCT00122369|O1|Outcome|Known Benign Disease|Women who were diagnosed to have benign disease
1239588|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
1239589|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
1239590|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
1239591|NCT00122369|E3|Reported Event|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient’s anxiety, pain, or worries according to the prescriptions of the script.
1239592|NCT00122369|E2|Reported Event|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
1239593|NCT00122369|E1|Reported Event|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
1239594|NCT00122317|B1|Baseline|Eculizumab|eculizumab: 600 mg intravenous infusion every week x 4 then 900 mg iv every two weeks
1239595|NCT00122317|P1|Participant Flow|Eculizumab|eculizumab: 600 mg intravenous infusion every week x 4 then 900 mg iv every two weeks
1239596|NCT00122317|O1|Outcome|Eculizumab|eculizumab: 600 mg intravenous infusion every week x 4 then 900 mg iv every two weeks
1239597|NCT00122317|E1|Reported Event|Eculizumab|eculizumab: 600 mg intravenous infusion every week x 4 then 900 mg iv every two weeks
1239598|NCT00122187|B3|Baseline|Total|Total of all reporting groups
1239599|NCT00122187|B2|Baseline|Usual Care|The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
1239600|NCT00122187|B1|Baseline|Electronic Consult System|A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
1239601|NCT00122187|P2|Participant Flow|Usual Care|The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
1239602|NCT00122187|P1|Participant Flow|Electronic Consult System|A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
1239603|NCT00122187|O4|Outcome|Usual Care 2nd Site (2b)|The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
1239604|NCT00122187|O3|Outcome|Usual Care 1st Site (1b)|The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
1239605|NCT00122187|O2|Outcome|Electronic Consult System 2nd Site (2a)|A new consult system designed to automatically send a gastroenterology consult request for patients with FOBT+ results
1239606|NCT00122187|O1|Outcome|Electronic Consult System 1st Site (1a)|A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
1239607|NCT00122187|O4|Outcome|Usual Care 2nd Site (2b)|The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
1239608|NCT00122187|O3|Outcome|Usual Care 1st Site (1b)|The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
1239609|NCT00122187|O2|Outcome|Electronic Consult System 2nd Site (2a)|A new consult system designed to automatically send a gastroenterology consult request for patients with FOBT+ results
1239610|NCT00122187|O1|Outcome|Electronic Consult System 1st Site (1a)|A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
1239617|NCT00122135|P1|Participant Flow|Patients With VI|"patients / surrogates who did receive the Values Inventory prior to their clinic appointment~Values history discussion w/physician & patient/surrogate: 128 patient/physician values history discussions were taped, also 4 case studies with surrogates were completed."
1239618|NCT00122135|O2|Outcome|Patients Without VI|Patients who did not receive the Values History prior to their clinic appointment (usual care)
1239619|NCT00122135|O1|Outcome|Patients With VI|Patients who filled out the Values History prior to their clinic appointment
1239620|NCT00122135|E2|Reported Event|Patients Without VI|"Clinic encounter w/physician & patient and/or surrogate - Patients who did not receive the VI prior to their physician clinic encounter~Clinic encounter w/physician & patient and/or surrogate: 128 patient/physician values history discussions were taped, also 4 case studies with surrogates were completed."
1239621|NCT00122135|E1|Reported Event|Patients With VI|"Clinic encounter w/physician & patient and/or surrogate - Patients who completed the VI prior to their physician clinic encounter~Clinic encounter w/physician & patient and/or surrogate: 128 patient/physician values history discussions were taped, also 4 case studies with surrogates were completed."
1239622|NCT00122109|B3|Baseline|Total|Total of all reporting groups
1239623|NCT00122109|B2|Baseline|Face to Face AMT|"The control arm is the group condition that received the CPT treatment intervention via a traditional face to face modality as compared to the experimental condition which is the videoteleconferncing modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a face to face modality."
1239624|NCT00122109|B1|Baseline|Videoteleconferencing AMT|"The experimental arm is the group condition that received the CPT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
1239625|NCT00122109|P2|Participant Flow|Face to Face AMT|"The control arm is the group condition that received the CPT treatment intervention face-to-face traditional modality as compared to the experimental condition which is the via a videoteleconferencing modality .~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
1239626|NCT00122109|P1|Participant Flow|Videoteleconferencing AMT|"The experimental arm is the group condition that received the CPT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
1239627|NCT00122109|O2|Outcome|Face to Face AMT|"The control arm is the group condition that received the CPT treatment intervention via a traditional face to face modality as compared to the experimental condition which is the videoteleconferencing modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a face to face modality."
1239628|NCT00122109|O1|Outcome|Videoteleconferencing AMT|"The experimental arm is the group condition that received the CPT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
1239629|NCT00122109|O2|Outcome|Face to Face AMT|The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
1239630|NCT00122109|O1|Outcome|Videoteleconferencing AMT|The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
1239631|NCT00122109|O2|Outcome|Face to Face AMT|The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
1239632|NCT00122109|O1|Outcome|Videoteleconferencing AMT|The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
1239633|NCT00122109|O2|Outcome|Face to Face AMT|"The control arm is the group condition that received the CPT treatment intervention via a traditional face to face modality as compared to the experimental condition which is the videoteleconferencing modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a face to face modality."
1239634|NCT00122109|O1|Outcome|Videoteleconferencing AMT|"The experimental arm is the group condition that received the CPT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
1239635|NCT00122109|O2|Outcome|Face to Face AMT|The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
1239636|NCT00122109|O1|Outcome|Videoteleconferencing AMT|The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
1239637|NCT00122109|O2|Outcome|Face to Face AMT|The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
1239638|NCT00122109|O1|Outcome|Videoteleconferencing AMT|The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
1239639|NCT00122109|O2|Outcome|Face to Face AMT|The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
1239640|NCT00122109|O1|Outcome|Videoteleconferencing AMT|The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
1239641|NCT00122109|O2|Outcome|Face to Face AMT|The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
1239642|NCT00122109|O1|Outcome|Videoteleconferencing AMT|The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
1239643|NCT00122109|O2|Outcome|Face to Face AMT|"The control arm is the group condition that received the CPT treatment intervention via the traditional face to face modality as compared to the control condition which is the experimental videoteleconferencing modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
1239644|NCT00122109|O1|Outcome|Videoteleconferencing AMT|"The experimental arm is the group condition that received the CPT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
1239645|NCT00122109|O2|Outcome|Face to Face AMT|The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
1239646|NCT00122109|O1|Outcome|Videoteleconferencing AMT|The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
1239647|NCT00122109|E2|Reported Event|Face to Face AMT|"The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
1239648|NCT00122109|E1|Reported Event|Videoteleconferencing AMT|"The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
1239649|NCT00121836|B1|Baseline|Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev|"First Study Treatment Phase:~Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.~Second Study Treatment Phase:~Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.~Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.~Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle."
1239670|NCT00121810|O1|Outcome|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
1239671|NCT00121810|O2|Outcome|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
1250415|NCT00092677|B3|Baseline|Total|Total of all reporting groups
1239650|NCT00121836|P1|Participant Flow|Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev|"First Study Treatment Phase:~Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.~Second Study Treatment Phase:~Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.~Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.~Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle."
1239651|NCT00121836|O1|Outcome|Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev|"First Study Treatment Phase:~Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.~Second Study Treatment Phase:~Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.~Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.~Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle."
1239652|NCT00121836|O2|Outcome|First Study Treatment Phase Only|"Capecitabine+Bevacizumab:~Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle."
1239653|NCT00121836|O1|Outcome|Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev|"First Study Treatment Phase:~Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.~Second Study Treatment Phase:~Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.~Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.~Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle."
1239654|NCT00121836|O2|Outcome|First Study Treatment Phase Only|"Capecitabine+Bevacizumab:~Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle."
1239655|NCT00121836|O1|Outcome|Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev|"First Study Treatment Phase:~Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.~Second Study Treatment Phase:~Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.~Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.~Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle."
1239656|NCT00121836|O1|Outcome|Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev|"First Study Treatment Phase:~Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.~Second Study Treatment Phase:~Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.~Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.~Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle."
1239911|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239657|NCT00121836|E1|Reported Event|Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev|"First Study Treatment Phase:~Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.~Second Study Treatment Phase:~Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.~Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.~Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle."
1239658|NCT00121810|B3|Baseline|Total|Total of all reporting groups
1239659|NCT00121810|B2|Baseline|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
1239660|NCT00121810|B1|Baseline|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
1239661|NCT00121810|P2|Participant Flow|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
1239662|NCT00121810|P1|Participant Flow|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
1239663|NCT00121810|O2|Outcome|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
1239664|NCT00121810|O1|Outcome|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
1239665|NCT00121810|O2|Outcome|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
1239666|NCT00121810|O1|Outcome|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
1239667|NCT00121810|O2|Outcome|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
1239668|NCT00121810|O1|Outcome|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
1239669|NCT00121810|O2|Outcome|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
1240109|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
1239672|NCT00121810|O1|Outcome|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
1239673|NCT00121810|E2|Reported Event|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
1239674|NCT00121810|E1|Reported Event|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
1239675|NCT00121719|B15|Baseline|Total|Total of all reporting groups
1239676|NCT00121719|B14|Baseline|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239677|NCT00121719|B13|Baseline|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239678|NCT00121719|B12|Baseline|25 mg Lenvatinib Fed/Fasted|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
1239679|NCT00121719|B11|Baseline|25 mg Lenvatinib Fasted/Fed|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
1239680|NCT00121719|B10|Baseline|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239681|NCT00121719|B9|Baseline|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239682|NCT00121719|B8|Baseline|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239683|NCT00121719|B7|Baseline|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239964|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239965|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239684|NCT00121719|B6|Baseline|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239685|NCT00121719|B5|Baseline|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239686|NCT00121719|B4|Baseline|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239687|NCT00121719|B3|Baseline|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239706|NCT00121719|O2|Outcome|25 mg Lenvatinib Fasted|Participants who agreed to participate in the food-effect study received a single oral dose of lenvatinib (25 mg) after a high-fat meal (including potatoes and bacon) or following at least a 10 hour fast on the morning of either Cycle 1 Day 15 or Cycle 1 Day 22 between 8:00 am and 10:00 am. Whichever state (fed or fasted) the participant took the lenvatinib on Day 15, they did the opposite on Day 22. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
1240286|NCT00120289|B3|Baseline|Total|Total of all reporting groups
1239688|NCT00121719|B2|Baseline|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239689|NCT00121719|B1|Baseline|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
1239690|NCT00121719|P14|Participant Flow|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239699|NCT00121719|P5|Participant Flow|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239691|NCT00121719|P13|Participant Flow|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239692|NCT00121719|P12|Participant Flow|25 mg Lenvatinib Fed/Fasted|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
1239693|NCT00121719|P11|Participant Flow|25 mg Lenvatinib Fasted/Fed|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
1239694|NCT00121719|P10|Participant Flow|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239695|NCT00121719|P9|Participant Flow|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239696|NCT00121719|P8|Participant Flow|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239912|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1240205|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
1239697|NCT00121719|P7|Participant Flow|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239698|NCT00121719|P6|Participant Flow|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239719|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239700|NCT00121719|P4|Participant Flow|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239701|NCT00121719|P3|Participant Flow|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239702|NCT00121719|P2|Participant Flow|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239703|NCT00121719|P1|Participant Flow|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
1239704|NCT00121719|O2|Outcome|25 mg Lenvatinib Fasted State|Participants who agreed to participate in the food-effect study received a single oral dose of lenvatinib (25 mg) after a high-fat meal (including potatoes and bacon) or following at least a 10 hour fast on the morning of either Cycle 1 Day 15 or Cycle 1 Day 22 between 8:00 am and 10:00 am. Whichever state (fed or fasted) the participant took the lenvatinib on Day 15, they did the opposite on Day 22. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
1239705|NCT00121719|O1|Outcome|25 mg Lenvatinib Fed State|Participants who agreed to participate in the food-effect study received a single oral dose of lenvatinib (25 mg) after a high-fat meal (including potatoes and bacon) or following at least a 10 hour fast on the morning of either Cycle 1 Day 15 or Cycle 1 Day 22 between 8:00 am and 10:00 am. Whichever state (fed or fasted) the participant took the lenvatinib on Day 15, they did the opposite on Day 22. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
1239913|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1241043|NCT00117949|E4|Reported Event|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
1239707|NCT00121719|O1|Outcome|25 mg Lenvatinib Fed|Participants who agreed to participate in the food-effect study received a single oral dose of lenvatinib (25 mg) after a high-fat meal (including potatoes and bacon) or following at least a 10 hour fast on the morning of either Cycle 1 Day 15 or Cycle 1 Day 22 between 8:00 am and 10:00 am. Whichever state (fed or fasted) the participant took the lenvatinib on Day 15, they did the opposite on Day 22. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
1239708|NCT00121719|O2|Outcome|25 mg Lenvatinib Fasted|Participants who agreed to participate in the food-effect study received a single oral dose of lenvatinib (25 mg) after a high-fat meal (including potatoes and bacon) or following at least a 10 hour fast on the morning of either Cycle 1 Day 15 or Cycle 1 Day 22 between 8:00 am and 10:00 am. Whichever state (fed or fasted) the participant took the lenvatinib on Day 15, they did the opposite on Day 22. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
1239709|NCT00121719|O1|Outcome|25 mg Lenvatinib Fed|Participants who agreed to participate in the food-effect study received a single oral dose of lenvatinib (25 mg) after a high-fat meal (including potatoes and bacon) or following at least a 10 hour fast on the morning of either Cycle 1 Day 15 or Cycle 1 Day 22 between 8:00 am and 10:00 am. Whichever state (fed or fasted) the participant took the lenvatinib on Day 15, they did the opposite on Day 22. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
1239710|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1250416|NCT00092677|B2|Baseline|Placebo|
1239711|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239712|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239713|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239714|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239715|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239914|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239915|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1241044|NCT00117949|E3|Reported Event|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
1239716|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239717|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239718|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239720|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239721|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
1239722|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239723|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239916|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239917|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1240030|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
1239724|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239725|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239726|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239727|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239728|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239729|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239730|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239731|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239918|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239919|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239920|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239732|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239733|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
1239734|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239743|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1240110|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE
1239735|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239736|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239737|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239738|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239739|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239921|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239922|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1241045|NCT00117949|E2|Reported Event|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
1239740|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239741|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239742|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239744|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239745|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
1239746|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239747|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239923|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239924|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1240031|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1239748|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239749|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239750|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239751|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239752|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239753|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239754|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239755|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239925|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239926|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239927|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239756|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239757|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
1239758|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239767|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239759|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239760|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239761|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239762|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239763|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239928|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239929|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1240032|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1239764|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239765|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239766|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239768|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239769|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
1239770|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239771|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239930|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239931|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1241046|NCT00117949|E1|Reported Event|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
1239772|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239773|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239774|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239775|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239776|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239777|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239778|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239779|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239932|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239933|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239934|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239780|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239781|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
1239782|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239791|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1250578|NCT00092495|O1|Outcome|Girls 10-15 Years|
1239783|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239784|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239785|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239786|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239787|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239935|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239936|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1240033|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1239788|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239789|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239790|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239792|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239793|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
1239794|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239795|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239937|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239938|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1241377|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1239796|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239797|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239798|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239799|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239800|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239801|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239802|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239803|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239939|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239940|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239941|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239804|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239805|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
1239806|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239815|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1253131|NCT00084136|E1|Reported Event|ZDV/3TC+EFV|
1239807|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239808|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239809|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239810|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239811|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239942|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239943|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1241378|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1239812|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239813|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239814|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239816|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239817|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
1239818|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239819|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239944|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239945|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1240034|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
1239820|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239821|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239822|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239823|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239824|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239825|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239826|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239827|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239946|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239947|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239948|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239828|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239829|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
1239830|NCT00121719|O4|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided).
1239831|NCT00121719|O3|Outcome|25 mg Lenvatinib|Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided).
1239832|NCT00121719|O2|Outcome|12 - 20 mg Lenvatinib|Lenvatinib tablets (at the appropriate dose for a given dose level) were taken orally, once daily on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided).
1239833|NCT00121719|O1|Outcome|0.2 - 6.4 mg Lenvatinib|Lenvatinib tablets (at the appropriate dose for a given dose level) were taken orally, once daily on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided).
1239953|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1253265|NCT00083174|O1|Outcome|Exemestane|one 25 mg tablet daily in am
1239834|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239835|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239836|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239837|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239846|NCT00121719|O14|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239838|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239839|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239840|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239954|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239955|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1240101|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
1239841|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239842|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239843|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239844|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239845|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
1239902|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239903|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239904|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239847|NCT00121719|O13|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239848|NCT00121719|O12|Outcome|25 mg Lenvatinib Fed/Fasted|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
1239849|NCT00121719|O11|Outcome|25 mg Lenvatinib Fasted/Fed|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
1239956|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239957|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239958|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239850|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239851|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239852|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239853|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239854|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239855|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239905|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1240179|NCT00121134|O1|Outcome|Group A- Bevacizumab Alone|Bevacizumab 15 mg/kg every 3 wks for 1 year
1239856|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239857|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239959|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1240102|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE
1239858|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239859|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239860|NCT00121719|O1|Outcome|Lenvatinib|"Participants not in the food-effect pilot study: 25 mg lenvatinib was administered orally once daily on an empty stomach shortly after waking. Participants fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this period. Grapefruit juice was to be avoided during the study.~Participants in the food-effect pilot study: 25 mg lenvatinib was administered as described above except on Days 15 and 22 in Cycle 1. Participants in this pilot study were randomly assigned to receive lenvatinib under a fed state (following a high fat meal) or fasting state (overnight fast greater than or equal to 10 hours) on Day 15, then in the reverse/untried state on Day 22. For both cases, no food was allowed for 4 hour following administration of lenvatinib."
1239861|NCT00121719|E14|Reported Event|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239862|NCT00121719|E13|Reported Event|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239863|NCT00121719|E12|Reported Event|25 mg Lenvatinib Fed/Fasted|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
1239864|NCT00121719|E11|Reported Event|25 mg Lenvatinib Fasted/Fed|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
1239906|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239907|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239865|NCT00121719|E10|Reported Event|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239866|NCT00121719|E9|Reported Event|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239867|NCT00121719|E8|Reported Event|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239868|NCT00121719|E7|Reported Event|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239869|NCT00121719|E6|Reported Event|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and theMTD was determined. An additional 12 participants were treated at the MTD level.
1239870|NCT00121719|E5|Reported Event|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239871|NCT00121719|E4|Reported Event|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239872|NCT00121719|E3|Reported Event|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239908|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239909|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239910|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239873|NCT00121719|E2|Reported Event|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
1239960|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239961|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239962|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239963|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239874|NCT00121719|E1|Reported Event|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
1239875|NCT00121667|B5|Baseline|Total|Total of all reporting groups
1239876|NCT00121667|B4|Baseline|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239877|NCT00121667|B3|Baseline|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239878|NCT00121667|B2|Baseline|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239879|NCT00121667|B1|Baseline|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239880|NCT00121667|P4|Participant Flow|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239881|NCT00121667|P3|Participant Flow|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239882|NCT00121667|P2|Participant Flow|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239883|NCT00121667|P1|Participant Flow|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239884|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239885|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239886|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239887|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239888|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239889|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239890|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239891|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239892|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239893|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239894|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239895|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239896|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239897|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239898|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239899|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239900|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239901|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239986|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1239949|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239950|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239951|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239952|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239966|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239967|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239968|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239969|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239970|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239971|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239972|NCT00121667|E4|Reported Event|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239973|NCT00121667|E3|Reported Event|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239974|NCT00121667|E2|Reported Event|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239975|NCT00121667|E1|Reported Event|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
1239976|NCT00121641|B5|Baseline|Total|Total of all reporting groups
1239977|NCT00121641|B4|Baseline|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
1239978|NCT00121641|B3|Baseline|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1239979|NCT00121641|B2|Baseline|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1239980|NCT00121641|B1|Baseline|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1239981|NCT00121641|P5|Participant Flow|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1239982|NCT00121641|P4|Participant Flow|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
1239983|NCT00121641|P3|Participant Flow|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1239984|NCT00121641|P2|Participant Flow|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1239985|NCT00121641|P1|Participant Flow|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks short term [ST], 42 months long term [LT]); Metformin 500-2000 mg (as needed for rescue).
1239987|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1239988|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1239989|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1239990|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1239991|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1239992|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
1239993|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1239994|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1239995|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1239996|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
1239997|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1239998|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1239999|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240000|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240001|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240002|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
1240003|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240004|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240005|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240006|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
1240103|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
1240007|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240008|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240009|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240010|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
1240011|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240012|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240013|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240014|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
1240015|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240016|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240017|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240018|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
1240019|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240020|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240021|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240022|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
1240023|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240024|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240025|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240026|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
1240027|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240028|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240029|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1241379|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1240035|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240036|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240037|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240038|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
1240039|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240040|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240041|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240042|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
1240043|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240044|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240045|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240046|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
1240047|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240048|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240049|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240050|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
1240051|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240052|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240053|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240054|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
1240055|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240056|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240057|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240058|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
1240059|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240060|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240061|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240062|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
1240063|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240064|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240065|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240066|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240067|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240068|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240069|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240070|NCT00121641|O1|Outcome|Open Label Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240071|NCT00121641|O1|Outcome|Open Label Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240072|NCT00121641|O1|Outcome|Open Label Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240073|NCT00121641|O1|Outcome|Open-Label Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240074|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
1240075|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240076|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240077|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1251578|NCT00089661|O1|Outcome|Denosumab 60 mg Q6M|
1240078|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
1240079|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240080|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240081|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240082|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
1240083|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240084|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240085|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240086|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
1240087|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240088|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240089|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240090|NCT00121641|E5|Reported Event|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240091|NCT00121641|E4|Reported Event|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240092|NCT00121641|E3|Reported Event|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240093|NCT00121641|E2|Reported Event|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
1240094|NCT00121641|E1|Reported Event|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
1240095|NCT00121485|B3|Baseline|Total|Total of all reporting groups
1240096|NCT00121485|B2|Baseline|HeartMate XVE|Implantation of HeartMate XVE LVAS
1240097|NCT00121485|B1|Baseline|HeartMate II|Implantation of HeartMate II LVAS
1240098|NCT00121485|P2|Participant Flow|HeartMate XVE|Implantation of HeartMate XVE LVAS
1240099|NCT00121485|P1|Participant Flow|HeartMate II|Implantation of HeartMate II LVAS
1240100|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE
1240111|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
1240112|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE
1240113|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
1240114|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE
1240115|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
1240116|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE LVAS
1240117|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
1240118|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE LVAS
1240119|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
1240120|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE LVAS
1240121|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
1240122|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE LVAS
1240123|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
1240124|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE LVAS
1240125|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
1240126|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE LVAS
1240127|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
1240128|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE LVAS
1240129|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
1240130|NCT00121485|E2|Reported Event|HeartMate XVE|Implantation of HeartMate XVE LVAS
1240131|NCT00121485|E1|Reported Event|HeartMate II|Implantation of HeartMate II LVAS
1240132|NCT00121472|B1|Baseline|HM II|HeartMate II LVAS used as a bridge to cardiac transplantation with at least 1-year follow-up (133 Pivotal Study Cohort and 61 US Continued Access Protocol)
1240133|NCT00121472|P1|Participant Flow|HeartMate II (HMII)|HeartMate II Left Ventricular Assist System (HMII LVAS) used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP)).
1240134|NCT00121472|O1|Outcome|HM II|HeartMate II LVAS used as a bridge to cardiac transplantation with at least 1-year follow-up (133 Pivotal Study Cohort and 61 US Continued Access Protocol)
1240135|NCT00121472|O1|Outcome|HMII Replacement|HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
1241380|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1240136|NCT00121472|O1|Outcome|HMII|HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
1240137|NCT00121472|O1|Outcome|HMII|HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
1240138|NCT00121472|O1|Outcome|HM II|HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
1240139|NCT00121472|O1|Outcome|HMII|HeartMate II LVAS used as a bridge to cardiac transplantation with at least 1-year follow-up (133 Pivotal Study Cohort and 61 US Continued Access Protocol)
1240140|NCT00121472|O1|Outcome|HM II|HeartMate II LVAS used as a bridge to cardiac transplantation with at least 1-year follow-up (133 Pivotal Study Cohort and 61 US Continued Access Protocol)
1240141|NCT00121472|O1|Outcome|HM II|HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
1240142|NCT00121472|E1|Reported Event|HMII|HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
1240143|NCT00121238|B1|Baseline|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.~cilengitide : Given IV~Experimental drug treatment : Correlative studies"
1240144|NCT00121238|P1|Participant Flow|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.~cilengitide : Given IV~Experimental drug treatment : Correlative studies"
1240145|NCT00121238|O1|Outcome|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.~cilengitide : Given IV~Experimental drug treatment : Correlative studies"
1240146|NCT00121238|O1|Outcome|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.~cilengitide : Given IV~Experimental drug treatment : Correlative studies"
1240195|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240147|NCT00121238|O1|Outcome|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.~cilengitide : Given IV~Experimental drug treatment : Correlative studies"
1240148|NCT00121238|O1|Outcome|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.~cilengitide : Given IV~Experimental drug treatment : Correlative studies"
1240149|NCT00121238|O1|Outcome|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.~cilengitide : Given IV~Experimental drug treatment : Correlative studies"
1240150|NCT00121238|E1|Reported Event|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.~cilengitide : Given IV~Experimental drug treatment : Correlative studies"
1240180|NCT00121134|E4|Reported Event|Group D-bevacizumab + Capecitibine (24wks)|capecitabine 2000 mg orally twice per day for 7 days on/7 days off for 24 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year.
1240151|NCT00121225|B1|Baseline|Arm I|"Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.~vorinostat"
1240152|NCT00121225|P1|Participant Flow|Arm I|"Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.~vorinostat"
1240153|NCT00121225|O1|Outcome|Arm I|"Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.~vorinostat"
1240154|NCT00121225|E1|Reported Event|Arm I|"Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.~vorinostat"
1240155|NCT00121199|B1|Baseline|CHOP + Rituximab + Bevacizumab|Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
1240156|NCT00121199|P1|Participant Flow|CHOP + Rituximab + Bevacizumab|Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
1240157|NCT00121199|O1|Outcome|CHOP + Rituximab + Bevacizumab|Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
1240158|NCT00121199|O1|Outcome|CHOP + Rituximab + Bevacizumab|Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
1240159|NCT00121199|O1|Outcome|CHOP + Rituximab + Bevacizumab|Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
1240160|NCT00121199|O1|Outcome|CHOP + Rituximab + Bevacizumab|Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
1240161|NCT00121199|E1|Reported Event|CHOP + Rituximab + Bevacizumab|Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
1240162|NCT00121186|B1|Baseline|Nonmyeloablative Allogeneic Stem Cell Transplant|Patients are given fludarabine 30 mg/m^2 on days -6 to -2 and melphalan 70 mg/m^2 on days -3 and -2, then transplanted with donor peripheral blood stem cells or harvested bone marrow stem cells on day 0. Patients are then given post-transplant immunosuppression consisting of tacrolimus 0.06 mg/kg/day on days -3 to 100 and methotrexate 5 mg/m^2 on days 1, 3, and 7.
1240163|NCT00121186|P1|Participant Flow|Nonmyeloablative Allogeneic Stem Cell Transplant|Patients are given fludarabine 30 mg/m^2 on days -6 to -2 and melphalan 70 mg/m^2 on days -3 and -2, then transplanted with donor peripheral blood stem cells or harvested bone marrow stem cells on day 0. Patients are then given post-transplant immunosuppression consisting of tacrolimus 0.06 mg/kg/day on days -3 to 100 and methotrexate 5 mg/m^2 on days 1, 3, and 7.
1240404|NCT00119379|O2|Outcome|Switch to TDF|"Switch of AZT or d4T to tenofovir~Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir"
1253266|NCT00083174|O2|Outcome|Placebo|one tablet daily in am
1240164|NCT00121186|O1|Outcome|Nonmyeloablative Allogeneic Stem Cell Transplant|Patients are given fludarabine 30 mg/m^2 on days -6 to -2 and melphalan 70 mg/m^2 on days -3 and -2, then transplanted with donor peripheral blood stem cells or harvested bone marrow stem cells on day 0. Patients are then given post-transplant immunosuppression consisting of tacrolimus 0.06 mg/kg/day on days -3 to 100 and methotrexate 5 mg/m^2 on days 1, 3, and 7.
1240165|NCT00121186|O1|Outcome|Nonmyeloablative Allogeneic Stem Cell Transplant|Patients are given fludarabine 30 mg/m^2 on days -6 to -2 and melphalan 70 mg/m^2 on days -3 and -2, then transplanted with donor peripheral blood stem cells or harvested bone marrow stem cells on day 0. Patients are then given post-transplant immunosuppression consisting of tacrolimus 0.06 mg/kg/day on days -3 to 100 and methotrexate 5 mg/m^2 on days 1, 3, and 7.
1240166|NCT00121186|E1|Reported Event|Nonmyeloablative Allogeneic Stem Cell Transplant|
1240167|NCT00121134|B5|Baseline|Total|Total of all reporting groups
1240168|NCT00121134|B4|Baseline|Group D-bevacizumab + Capecitibine (24wks)|capecitabine 2000 mg orally twice per day for 7 days on/7 days off for 24 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year.
1240169|NCT00121134|B3|Baseline|Group C-Bevacizumab + Capcitabine(18 Wks)|capecitabine 2000 mg/m2/day 14 days on/7 days off for 18 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year
1240170|NCT00121134|B2|Baseline|Group B-Bevacizumab+Cyclophosphamide+Methotrexate|Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.
1240171|NCT00121134|B1|Baseline|Group A- Bevacizumab Alone|Bevacizumab 15 mg/kg every 3 wks for 1 year
1240172|NCT00121134|P4|Participant Flow|Group D-bevacizumab + Capecitibine (24wks)|capecitabine 2000 mg orally twice per day for 7 days on/7 days off for 24 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year.
1240173|NCT00121134|P3|Participant Flow|Group C-Bevacizumab + Capcitabine(18 Wks)|capecitabine 2000 mg/m2/day 14 days on/7 days off for 18 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year
1240174|NCT00121134|P2|Participant Flow|Group B-Bevacizumab+Cyclophosphamide+Methotrexate|Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.
1240175|NCT00121134|P1|Participant Flow|Group A- Bevacizumab Alone|Bevacizumab 15 mg/kg every 3 wks for 1 year
1240176|NCT00121134|O4|Outcome|Group D-bevacizumab + Capecitibine (24wks)|capecitabine 2000 mg orally twice per day for 7 days on/7 days off for 24 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year.
1240177|NCT00121134|O3|Outcome|Group C-Bevacizumab + Capcitabine(18 Wks)|capecitabine 2000 mg/m2/day 14 days on/7 days off for 18 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year
1240178|NCT00121134|O2|Outcome|Group B-Bevacizumab+Cyclophosphamide+Methotrexate|Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.
1251579|NCT00089661|E2|Reported Event|Denosumab 60 mg Q6M|
1240181|NCT00121134|E3|Reported Event|Group C-Bevacizumab + Capcitabine(18 Wks)|capecitabine 2000 mg/m2/day 14 days on/7 days off for 18 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year
1240182|NCT00121134|E2|Reported Event|Group B-Bevacizumab+Cyclophosphamide+Methotrexate|Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.
1240183|NCT00121134|E1|Reported Event|Group A- Bevacizumab Alone|Bevacizumab 15 mg/kg every 3 wks for 1 year
1240184|NCT00120874|B3|Baseline|Total|Total of all reporting groups
1240185|NCT00120874|B2|Baseline|Memantine|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240186|NCT00120874|B1|Baseline|Individualized Management and Memantine|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240187|NCT00120874|P2|Participant Flow|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240188|NCT00120874|P1|Participant Flow|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240189|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240190|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240191|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240192|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240193|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240194|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240196|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240197|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240198|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240199|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240200|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240201|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240202|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240203|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240204|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240206|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240207|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240208|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240209|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240210|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240211|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240212|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240213|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240214|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240215|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240216|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240217|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240405|NCT00119379|O1|Outcome|Uridine Supplementation|"NucleomaxX 36 grams TID every other day~NucleomaxX: NucleomaxX 36 grams TID every other day"
1240218|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240219|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240220|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240221|NCT00120874|E2|Reported Event|Memantine|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240222|NCT00120874|E1|Reported Event|Individualized Management and Memantine|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
1240223|NCT00120627|B3|Baseline|Total|Total of all reporting groups
1240224|NCT00120627|B2|Baseline|Control Arm: Medication & Case Management Alone|"Usual care consisting of medication and case-management.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
1240225|NCT00120627|B1|Baseline|Treatment Arm: Mantram + Medication & Case Management|"Mantram Repetition Program (MRP) for PTSD delivered in this study as 6-week, 90-minute per week that targeted PTSD symptoms. It was offered as an adjunct to usual care consisting of medication and case-management. The MRP includes three strategies for training attention and managing symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools were presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states."
1240252|NCT00120523|B1|Baseline|Pimecrolimus|1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
1240226|NCT00120627|P2|Participant Flow|Arm 2: Usual Care|"Usual care consisting of medication and case-management.~Usual care consisted of medication and case management: Case management consisted of provider meetings with Veterans at least once per month and monitoring medications, if prescribed."
1240227|NCT00120627|P1|Participant Flow|Arm 1: Mantram + Usual Care|"The Mantram Repetition Program teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
1240228|NCT00120627|O2|Outcome|Arm 2: Usual Care Alone|"Usual care is defined as receiving 6 weeks of medication and case management, as needed by each patient. No group meetings.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
1240229|NCT00120627|O1|Outcome|Arm 1: Mantram + Usual Care|"Mantram Repetition Program for PTSD was delivered in this study as 6-week, 90-minute per week group that targeted PTSD symptoms. It was offered as an adjunct to usual care consisting of medication and case-management.~The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal."
1240230|NCT00120627|O2|Outcome|Arm 2: Usual Care Alone|"Usual care is defined as receiving 6 weeks of medication and case management, as needed by each patient. No group meetings.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
1240231|NCT00120627|O1|Outcome|Arm 1: Mantram + Usual Care|"Mantram Repetition Program for PTSD was delivered in this study as 6-week, 90-minute per week group that targeted PTSD symptoms. It was offered as an adjunct to usual care consisting of medication and case-management.~The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal."
1240232|NCT00120627|O2|Outcome|Arm 2: Usual Care Alone|"Usual care is defined as receiving 6 weeks of medication and case management, as needed by each patient. No group meetings.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
1240406|NCT00119379|E2|Reported Event|Switch to TDF|"Switch of AZT or d4T to tenofovir~Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir"
1240233|NCT00120627|O1|Outcome|Arm 1: Mantram + Usual Care|"Mantram Repetition Program (MRP) for PTSD was delivered in this study as 6-week, 90-minute per week group that targeted PTSD symptoms. It was offered as an adjunct to usual care consisting of medication and case-management.~The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources."
1240234|NCT00120627|O2|Outcome|Arm 2: Usual Care Alone|"Usual care is defined as receiving 6 weeks of medication and case management, as needed by each patient. No group meetings.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
1240235|NCT00120627|O1|Outcome|Arm 1: Mantram + Usual Care|"The Mantram Repetition Program teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
1240236|NCT00120627|O2|Outcome|Arm 2: Medication & Case Management (Usual Care) Alone|"Usual Care defined as receiving medication management and case management, as needed.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
1240237|NCT00120627|O1|Outcome|Arm 1: Mantram + Medication & Case Management (Usual Care)|"The Mantram Repetition Program teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
1240279|NCT00120406|P1|Participant Flow|Zilver PTX|Zilver® PTX™ Drug Eluting Vascular Stent
1240280|NCT00120406|O2|Outcome|PTA (Control)|Percutaneous balloon angioplasty
1240238|NCT00120627|O2|Outcome|Arm 2: Medication & Case Management (Usual Care) Alone|"Usual Care defined as receiving medication management and case management, as needed.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
1240239|NCT00120627|O1|Outcome|Arm 1: Mantram + Medication & Case Management (Usual Care)|"The Mantram Repetition Program teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
1240240|NCT00120627|O2|Outcome|Arm 2: Meds & Case Management (Usual Care Alone)|"Usual Care defined as receiving medication management and case management, as needed.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
1240241|NCT00120627|O1|Outcome|Arm 1: Mantram + Meds & Case Management (Usual Care)|"The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
1240242|NCT00120627|O2|Outcome|Arm 2: Medication & Case Management (Usual Care) Alone|"Usual Care defined as receiving medication management and case management, as needed.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
1240243|NCT00120627|O1|Outcome|Arm 1: Mantram + Medication & Case Management (Usual Care)|"The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting.."
1240244|NCT00120627|O2|Outcome|Arm 2: Medication & Case Management (Usual Care) Alone|"Usual Care defined as receiving medication management and case management, as needed.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
1240245|NCT00120627|O1|Outcome|Arm 1: Mantram + Medication & Case Management (Usual Care)|"The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
1240246|NCT00120627|O2|Outcome|Arm 2: Medication & Case Management (Usual Care Alone)|"Usual Care defined as receiving medication management and case management, as needed.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
1240247|NCT00120627|O1|Outcome|Arm 1: Mantram + Medication & Case Management (Usual Care)|"The Mantram Repetition Program teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
1240248|NCT00120627|E2|Reported Event|Arm 2|"Usual Care defined as receiving medication management and case management, as needed.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
1240249|NCT00120627|E1|Reported Event|Arm 1|"he MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
1240250|NCT00120523|B3|Baseline|Total|Total of all reporting groups
1240251|NCT00120523|B2|Baseline|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country’s label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
1240253|NCT00120523|P2|Participant Flow|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country’s label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
1240254|NCT00120523|P1|Participant Flow|Pimecrolimus|1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
1240255|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country’s label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
1240256|NCT00120523|O1|Outcome|Pimecrolimus|1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
1240257|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
1240258|NCT00120523|O1|Outcome|Pimecrolimus|Pimecrolimus 1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
1240259|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country’s label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
1240260|NCT00120523|O1|Outcome|Pimecrolimus|1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
1240261|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
1240262|NCT00120523|O1|Outcome|Pimecrolimus|Pimecrolimus 1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
1240263|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country’s label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
1240264|NCT00120523|O1|Outcome|Pimecrolimus|1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
1240265|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country’s label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
1240266|NCT00120523|O1|Outcome|Pimecrolimus|1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
1240267|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
1240268|NCT00120523|O1|Outcome|Pimecrolimus|Pimecrolimus 1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
1240269|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
1240270|NCT00120523|O1|Outcome|Pimecrolimus|Pimecrolimus 1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
1240271|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
1240272|NCT00120523|O1|Outcome|Pimecrolimus|Pimecrolimus 1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
1240273|NCT00120523|E2|Reported Event|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country’s label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
1240274|NCT00120523|E1|Reported Event|Pimecrolimus|1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
1240275|NCT00120406|B3|Baseline|Total|Total of all reporting groups
1240276|NCT00120406|B2|Baseline|PTA (Control)|Percutaneous balloon angioplasty
1240277|NCT00120406|B1|Baseline|Zilver PTX|Zilver® PTX™ Drug Eluting Vascular Stent
1240278|NCT00120406|P2|Participant Flow|PTA (Control)|Percutaneous balloon angioplasty
1240287|NCT00120289|B2|Baseline|Placebo + Simvastatin|"Simvastatin alone~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
1240288|NCT00120289|B1|Baseline|ERN + Simvastatin|"Extended release niacin plus simvastatin~Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
1240289|NCT00120289|P2|Participant Flow|Placebo + Simvastatin|"Simvastatin alone~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
1240290|NCT00120289|P1|Participant Flow|ERN + Simvastatin|"Extended release niacin plus simvastatin~Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
1240291|NCT00120289|O2|Outcome|Placebo + Simvastatin|"Simvastatin alone~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
1240292|NCT00120289|O1|Outcome|ERN + Simvastatin|"Extended release niacin plus simvastatin~Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
1240293|NCT00120289|O2|Outcome|Placebo + Simvastatin|"Simvastatin alone~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
1240294|NCT00120289|O1|Outcome|ERN + Simvastatin|"Extended release niacin plus simvastatin~Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
1240295|NCT00120289|O2|Outcome|Placebo + Simvastatin|"Simvastatin alone~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
1240296|NCT00120289|O1|Outcome|ERN + Simvastatin|"Extended release niacin plus simvastatin~Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
1240297|NCT00120289|O2|Outcome|Placebo + Simvastatin|"Simvastatin alone~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
1240298|NCT00120289|O1|Outcome|ERN + Simvastatin|"Extended release niacin plus simvastatin~Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
1240299|NCT00120289|E2|Reported Event|Placebo + Simvastatin|"Simvastatin alone~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
1240300|NCT00120289|E1|Reported Event|ERN + Simvastatin|"Extended release niacin plus simvastatin~Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
1240407|NCT00119379|E1|Reported Event|Uridine Supplementation|"NucleomaxX 36 grams TID every other day~NucleomaxX: NucleomaxX 36 grams TID every other day"
1240301|NCT00120250|B1|Baseline|Drug vs Placebo|Eszopiclone : The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
1240302|NCT00120250|P2|Participant Flow|Placebo, Then Eszopiclone|The total study duration is 8 weeks, with subjects receiving placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of 3mg eszopiclone, followed by another 1 week washout.
1240303|NCT00120250|P1|Participant Flow|Eszopiclone, Then Placebo|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of placebo, followed by another 1 week washout.
1240304|NCT00120250|O2|Outcome|Placebo|The total study duration is 8 weeks, with subjects receiving placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of 3mg eszopiclone, followed by another 1 week washout.
1240305|NCT00120250|O1|Outcome|Eszopiclone|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of placebo, followed by another 1 week washout.
1240306|NCT00120250|O2|Outcome|Placebo|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
1240307|NCT00120250|O1|Outcome|Eszopiclone|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
1240308|NCT00120250|O2|Outcome|Placebo|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
1240309|NCT00120250|O1|Outcome|Eszopiclone|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
1240310|NCT00120250|O2|Outcome|Placebo|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
1240311|NCT00120250|O1|Outcome|Eszopiclone|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
1240312|NCT00120250|O2|Outcome|Placebo|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
1240313|NCT00120250|O1|Outcome|Eszopiclone|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
1240454|NCT00119015|O2|Outcome|Fluticasone Propionate + Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Placebo - 10 mg po daily for 2 weeks"
1240314|NCT00120250|E1|Reported Event|Drug vs Placebo|Eszopiclone : The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
1240315|NCT00120042|B4|Baseline|Total|Total of all reporting groups
1240316|NCT00120042|B3|Baseline|3|Oral misoprostol to assist in placental delivery
1240317|NCT00120042|B2|Baseline|2|Intramuscular oxytocin injection
1240318|NCT00120042|B1|Baseline|1|No specific oxytocic to assist in placental delivery
1240319|NCT00120042|P3|Participant Flow|3|Oral misoprostol to assist in placental delivery
1240320|NCT00120042|P2|Participant Flow|2|Intramuscular oxytocin injection
1240321|NCT00120042|P1|Participant Flow|1|No specific oxytocic to assist in placental delivery
1240322|NCT00120042|O3|Outcome|3|Oral misoprostol to assist in placental delivery
1240323|NCT00120042|O2|Outcome|2|Intramuscular oxytocin injection
1240324|NCT00120042|O1|Outcome|1|No specific oxytocic to assist in placental delivery
1240325|NCT00120042|O3|Outcome|3|Oral misoprostol to assist in placental delivery
1240326|NCT00120042|O2|Outcome|2|Intramuscular oxytocin injection
1240327|NCT00120042|O1|Outcome|1|No specific oxytocic to assist in placental delivery
1240328|NCT00119678|B3|Baseline|Total|Total of all reporting groups
1240329|NCT00119678|B2|Baseline|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
1240330|NCT00119678|B1|Baseline|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
1240408|NCT00119262|B3|Baseline|Total|Total of all reporting groups
1241315|NCT00117312|B4|Baseline|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
1240331|NCT00119678|P2|Participant Flow|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
1240332|NCT00119678|P1|Participant Flow|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
1240333|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
1240334|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
1240335|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg). Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. BILAG A: presence of one or more serious features of lupus; BILAG B: more moderate features of the disease; BILAG C: mild symptomatic features; BILAG D: prior activity with no current symptoms due to active lupus; BILAG E: an organ that has never been involved."
1240455|NCT00119015|O1|Outcome|Fluticasone Propionate + Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Montelukast - 10 mg po daily for 2 weeks"
1251580|NCT00089661|E1|Reported Event|Placebo|
1240336|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
1240337|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
1240338|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
1240339|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
1240340|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
1240341|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
1240409|NCT00119262|B2|Baseline|Arm B (ddAC > BT > B)|Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
1240410|NCT00119262|B1|Baseline|Arm A (ddBAC > BT > B)|Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
1240342|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
1240343|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
1240344|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
1240345|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
1240346|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
1240347|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
1240348|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
1240427|NCT00119158|O1|Outcome|Active Therapy|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
1240349|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
1240350|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
1240351|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
1240411|NCT00119262|P2|Participant Flow|Arm B (ddAC > BT > B)|Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
1240412|NCT00119262|P1|Participant Flow|Arm A (ddBAC > BT > B)|Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
1240352|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
1240353|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
1240354|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
1240355|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
1240356|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
1240495|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240357|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
1240358|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
1240359|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
1240360|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
1240361|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
1240362|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
1240363|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
1240364|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
1240538|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240365|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
1240366|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
1240367|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
1240368|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
1240369|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
1240370|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
1240371|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
1240372|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
1240539|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240373|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
1240374|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
1240375|NCT00119678|E2|Reported Event|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
1240376|NCT00119678|E1|Reported Event|Abatacept|"Participants were administered abatacept (10 mg/kg) IV over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
1240377|NCT00119405|B1|Baseline|ARV Naive|ARV naive
1240378|NCT00119405|P1|Participant Flow|ARV Naive|ARV naive
1240379|NCT00119405|O1|Outcome|ARV Naive|ARV naive (have never been on antiretrovirals before)
1240380|NCT00119405|E1|Reported Event|ARV Naive|ARV naive (have never been on antiretrovirals before)
1240381|NCT00119392|B1|Baseline|Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)|"See Detailed Description~rituximab: Given IV~cyclosporine: Given orally~fludarabine phosphate: Given IV~mycophenolate mofetil: Given orally~yttrium Y 90 ibritumomab tiuxetan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~allogeneic hematopoietic stem cell transplantation: Undergo transplantation~total-body irradiation: Undergo TBI"
1240382|NCT00119392|P1|Participant Flow|Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)|"See Detailed Description~rituximab: Given IV~cyclosporine: Given orally~fludarabine phosphate: Given IV~mycophenolate mofetil: Given orally~yttrium Y 90 ibritumomab tiuxetan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~allogeneic hematopoietic stem cell transplantation: Undergo transplantation~total-body irradiation: Undergo TBI"
1240383|NCT00119392|O1|Outcome|Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)|"See Detailed Description~rituximab: Given IV~cyclosporine: Given orally~fludarabine phosphate: Given IV~mycophenolate mofetil: Given orally~yttrium Y 90 ibritumomab tiuxetan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~allogeneic hematopoietic stem cell transplantation: Undergo transplantation~total-body irradiation: Undergo TBI"
1240384|NCT00119392|O1|Outcome|Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)|"See Detailed Description~rituximab: Given IV~cyclosporine: Given orally~fludarabine phosphate: Given IV~mycophenolate mofetil: Given orally~yttrium Y 90 ibritumomab tiuxetan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~allogeneic hematopoietic stem cell transplantation: Undergo transplantation~total-body irradiation: Undergo TBI"
1240385|NCT00119392|O1|Outcome|Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)|"See Detailed Description~rituximab: Given IV~cyclosporine: Given orally~fludarabine phosphate: Given IV~mycophenolate mofetil: Given orally~yttrium Y 90 ibritumomab tiuxetan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~allogeneic hematopoietic stem cell transplantation: Undergo transplantation~total-body irradiation: Undergo TBI"
1240386|NCT00119392|O1|Outcome|Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)|"See Detailed Description~rituximab: Given IV~cyclosporine: Given orally~fludarabine phosphate: Given IV~mycophenolate mofetil: Given orally~yttrium Y 90 ibritumomab tiuxetan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~allogeneic hematopoietic stem cell transplantation: Undergo transplantation~total-body irradiation: Undergo TBI"
1240387|NCT00119392|O1|Outcome|Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)|"See Detailed Description~rituximab: Given IV~cyclosporine: Given orally~fludarabine phosphate: Given IV~mycophenolate mofetil: Given orally~yttrium Y 90 ibritumomab tiuxetan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~allogeneic hematopoietic stem cell transplantation: Undergo transplantation~total-body irradiation: Undergo TBI"
1240453|NCT00119015|O1|Outcome|Fluticasone Propionate + Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Montelukast - 10 mg po daily for 2 weeks"
1240388|NCT00119392|E1|Reported Event|Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)|"See Detailed Description~rituximab: Given IV~cyclosporine: Given orally~fludarabine phosphate: Given IV~mycophenolate mofetil: Given orally~yttrium Y 90 ibritumomab tiuxetan: Given IV~peripheral blood stem cell transplantation: Undergo transplantation~allogeneic hematopoietic stem cell transplantation: Undergo transplantation~total-body irradiation: Undergo TBI"
1240389|NCT00119379|B3|Baseline|Total|Total of all reporting groups
1240390|NCT00119379|B2|Baseline|Switch to TDF|"Switch of AZT or d4T to tenofovir~Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir"
1240391|NCT00119379|B1|Baseline|Uridine Supplementation|"NucleomaxX 36 grams TID every other day~NucleomaxX: NucleomaxX 36 grams TID every other day"
1240392|NCT00119379|P2|Participant Flow|Switch to TDF|"Switch of AZT or d4T to tenofovir~Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir"
1240393|NCT00119379|P1|Participant Flow|Uridine Supplementation|"NucleomaxX 36 grams TID every other day~NucleomaxX: NucleomaxX 36 grams TID every other day"
1240394|NCT00119379|O2|Outcome|Switch to TDF|"Switch of AZT or d4T to tenofovir~Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir"
1240395|NCT00119379|O1|Outcome|Uridine Supplementation|"NucleomaxX 36 grams TID every other day~NucleomaxX: NucleomaxX 36 grams TID every other day"
1240396|NCT00119379|O2|Outcome|Switch to TDF|"Switch of AZT or d4T to tenofovir~Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir"
1240397|NCT00119379|O1|Outcome|Uridine Supplementation|"NucleomaxX 36 grams TID every other day~NucleomaxX: NucleomaxX 36 grams TID every other day"
1240398|NCT00119379|O2|Outcome|Switch to TDF|"Switch of AZT or d4T to tenofovir~Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir"
1240399|NCT00119379|O1|Outcome|Uridine Supplementation|"NucleomaxX 36 grams TID every other day~NucleomaxX: NucleomaxX 36 grams TID every other day"
1240400|NCT00119379|O2|Outcome|Switch to TDF|"Switch of AZT or d4T to tenofovir~Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir"
1240401|NCT00119379|O1|Outcome|Uridine Supplementation|"NucleomaxX 36 grams TID every other day~NucleomaxX: NucleomaxX 36 grams TID every other day"
1240402|NCT00119379|O2|Outcome|Switch to TDF|"Switch of AZT or d4T to tenofovir~Tenofovir disoproxil fumarate: Switch thymidine NRTI to tenofovir"
1240403|NCT00119379|O1|Outcome|Uridine Supplementation|"NucleomaxX 36 grams TID every other day~NucleomaxX: NucleomaxX 36 grams TID every other day"
1240413|NCT00119262|O2|Outcome|Arm B (ddAC > BT > B)|Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
1240414|NCT00119262|O1|Outcome|Arm A (ddBAC > BT > B)|Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
1240415|NCT00119262|O2|Outcome|Arm B (ddAC > BT > B)|Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
1240416|NCT00119262|O1|Outcome|Arm A (ddBAC > BT > B)|Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
1240417|NCT00119262|O2|Outcome|Arm B (ddAC > BT > B)|Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
1240418|NCT00119262|O1|Outcome|Arm A (ddBAC > BT > B)|Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
1240419|NCT00119262|E2|Reported Event|Arm B (ddAC > BT > B)|Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
1240420|NCT00119262|E1|Reported Event|Arm A (ddBAC > BT > B)|Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
1240421|NCT00119158|B3|Baseline|Total|Total of all reporting groups
1240422|NCT00119158|B2|Baseline|Placebo Arm|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
1240423|NCT00119158|B1|Baseline|Active Therapy|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
1240424|NCT00119158|P2|Participant Flow|Placebo Arm|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
1240425|NCT00119158|P1|Participant Flow|Active Therapy|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
1240426|NCT00119158|O2|Outcome|Placebo Arm|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
1241381|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1240428|NCT00119158|O2|Outcome|Placebo Arm|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
1240429|NCT00119158|O1|Outcome|Active Therapy|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
1240430|NCT00119158|E2|Reported Event|Placebo Arm|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
1240431|NCT00119158|E1|Reported Event|Active Therapy|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
1240432|NCT00119041|B4|Baseline|Total|Total of all reporting groups
1240433|NCT00119041|B3|Baseline|Provider Interview|Qualitative interviews with providers
1240434|NCT00119041|B2|Baseline|Control CBOC|The CBOC's not involved in the intervention phase had their patients not be involved in the telemedicine visit, but traditional education.
1240435|NCT00119041|B1|Baseline|Telemedicine CBOC|"Designated CBOC's were involved in the intervention phase where their DM patients were asked to participate in a telemedicine visit.~The Diabetes Treatment Satisfaction Questionnaire: A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.~Diabetes Empowerment Scale: A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.~CBOC's undergo half-day joint-clinics via teleconference: A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park.~We did not collect gender and age related data."
1240436|NCT00119041|P3|Participant Flow|Provider Interview|Qualitative interviews with providers
1240437|NCT00119041|P2|Participant Flow|Control CBOC|The CBOC's not involved in the intervention phase had their patients not be involved in the telemedicine visit, but traditional education.
1240438|NCT00119041|P1|Participant Flow|Telemedicine CBOC|"Designated CBOC's were involved in the intervention phase where their DM patients were asked to participate in a telemedicine visit.~The Diabetes Treatment Satisfaction Questionnaire: A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.~Diabetes Empowerment Scale: A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.~CBOC's undergo half-day joint-clinics via teleconference: A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park."
1240439|NCT00119041|O2|Outcome|Control|non intervention group
1240440|NCT00119041|O1|Outcome|Telemedicine|Intervention group
1240441|NCT00119041|O2|Outcome|Control CBOC|Received the questionnaires by mail and had no intervention of diabetes teleconference
1240474|NCT00118911|E1|Reported Event|Cognitive-Behavioral Therapy (CBT)|Participants received 12 sessions of individual cognitive behavioral therapy following our protocol.
1240475|NCT00118898|B5|Baseline|Total|Total of all reporting groups
1241316|NCT00117312|B3|Baseline|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
1240442|NCT00119041|O1|Outcome|Telemedicine CBOC|"Designated CBOC's were involved in the intervention phase where their DM patients were asked to participate in a telemedicine visit.~The Behavioral: The Diabetes Treatment Satisfaction Questionnaire given during this phase along with the Behavioral: Diabetes Empowerment Scale and the Behavioral: CBOC's undergo half-day joint-clinics via teleconference.~The Diabetes Treatment Satisfaction Questionnaire: A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.~Diabetes Empowerment Scale: A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.~CBOC's undergo half-day joint-clinics via teleconference: A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park."
1240443|NCT00119041|E3|Reported Event|Provider Interviews|Qualitative interviews with providers.
1240444|NCT00119041|E2|Reported Event|Control CBOC|The CBOC's not involved in the intervention phase had their patients not be involved in the telemedicine visit, but traditional education.
1240445|NCT00119041|E1|Reported Event|Telemedicine CBOC|"Designated CBOC's were involved in the intervention phase where their DM patients were asked to participate in a telemedicine visit.~The Behavioral: The Diabetes Treatment Satisfaction Questionnaire given during this phase along with the Behavioral: Diabetes Empowerment Scale and the Behavioral: CBOC's undergo half-day joint-clinics via teleconference.~The Diabetes Treatment Satisfaction Questionnaire: A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.~Diabetes Empowerment Scale: A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.~CBOC's undergo half-day joint-clinics via teleconference: A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park."
1240446|NCT00119015|B3|Baseline|Total|Total of all reporting groups
1240447|NCT00119015|B2|Baseline|Fluticasone Propionate + Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Placebo - 10 mg po daily for 2 weeks"
1240448|NCT00119015|B1|Baseline|Fluticasone Propionate + Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Montelukast - 10 mg po daily for 2 weeks"
1240449|NCT00119015|P3|Participant Flow|Fluticasone Propionate+Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day (200 micrograms daily)~Placebo - 10 mg po daily"
1240450|NCT00119015|P2|Participant Flow|Fluticasone Propionate+Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day (200 micrograms daily)~Montelukast - 10 mg po daily"
1240451|NCT00119015|P1|Participant Flow|Fluticasone Propionate Only|Fluticasone propionate nasal spray - 2 sprays in each nostril once a day (200 micrograms daily)
1240452|NCT00119015|O2|Outcome|Fluticasone Propionate + Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Placebo - 10 mg po daily for 2 weeks"
1241382|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1240456|NCT00119015|O2|Outcome|Fluticasone Propionate + Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Placebo - 10 mg po daily for 2 weeks"
1240457|NCT00119015|O1|Outcome|Fluticasone Propionate + Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Montelukast - 10 mg po daily for 2 weeks"
1240458|NCT00119015|O2|Outcome|Fluticasone Propionate + Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Placebo - 10 mg po daily for 2 weeks"
1240459|NCT00119015|O1|Outcome|Fluticasone Propionate + Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Montelukast - 10 mg po daily for 2 weeks"
1240460|NCT00119015|O2|Outcome|Fluticasone Propionate + Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Placebo - 10 mg po daily for 2 weeks"
1240461|NCT00119015|O1|Outcome|Fluticasone Propionate + Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Montelukast - 10 mg po daily for 2 weeks"
1240462|NCT00119015|E2|Reported Event|Fluticasone Propionate + Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Placebo - 10 mg po daily for 2 weeks"
1240463|NCT00119015|E1|Reported Event|Fluticasone Propionate + Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Montelukast - 10 mg po daily for 2 weeks"
1240464|NCT00118911|B3|Baseline|Total|Total of all reporting groups
1240465|NCT00118911|B2|Baseline|Relaxation With Educational Support (RES)|Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
1240466|NCT00118911|B1|Baseline|Cognitive-Behavioral Therapy (CBT)|Participants received 12 sessions of individual cognitive behavioral therapy following our protocol.
1240467|NCT00118911|P2|Participant Flow|Relaxation With Educational Support (RES)|Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
1240468|NCT00118911|P1|Participant Flow|Cognitive-Behavioral Therapy (CBT)|Participants received 12 sessions of individual cognitive behavioral therapy following our protocol.
1240469|NCT00118911|O2|Outcome|Relaxation With Educational Support (RES)|Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
1240470|NCT00118911|O1|Outcome|Cognitive-Behavioral Therapy (CBT)|Participants received 12 sessions of individual cognitive behavioral therapy following our protocol.
1240471|NCT00118911|O2|Outcome|Relaxation With Educational Support (RES)|Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
1240472|NCT00118911|O1|Outcome|Cognitive-Behavioral Therapy (CBT)|Participants received 12 sessions of individual cognitive behavioral therapy following our protocol.
1240473|NCT00118911|E2|Reported Event|Relaxation With Educational Support (RES)|Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
1240591|NCT00118742|B3|Baseline|Total|Total of all reporting groups
1240476|NCT00118898|B4|Baseline|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240477|NCT00118898|B3|Baseline|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240478|NCT00118898|B2|Baseline|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240479|NCT00118898|B1|Baseline|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240480|NCT00118898|P4|Participant Flow|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240481|NCT00118898|P3|Participant Flow|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240482|NCT00118898|P2|Participant Flow|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240483|NCT00118898|P1|Participant Flow|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240484|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240485|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240486|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240487|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240488|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240489|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240490|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240491|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240492|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240493|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240494|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1241383|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1240496|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240497|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240498|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240499|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240500|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240501|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240502|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240503|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240504|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240505|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240506|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240507|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240508|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240509|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240510|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240511|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240512|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240513|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240514|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240515|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240516|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240517|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1241317|NCT00117312|B2|Baseline|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
1240518|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240519|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240520|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240521|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240522|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240523|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240524|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240525|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240526|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240527|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240528|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240529|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240530|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240531|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240532|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240533|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240534|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240535|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240536|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240537|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240540|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240541|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240542|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240543|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240544|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240545|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240546|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240547|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240548|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240549|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240550|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240551|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240552|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240553|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240554|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240555|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240556|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240557|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240558|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240559|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240560|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240561|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240562|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240563|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240564|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240565|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240566|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240567|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240568|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240569|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240570|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240571|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240572|NCT00118898|E4|Reported Event|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240573|NCT00118898|E3|Reported Event|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240574|NCT00118898|E2|Reported Event|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
1240575|NCT00118898|E1|Reported Event|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
1240576|NCT00118755|B3|Baseline|Total|Total of all reporting groups
1240577|NCT00118755|B2|Baseline|XELOX Q2W + Bevacizumab|"Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.~Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks."
1240578|NCT00118755|B1|Baseline|XELOX Q3W + Bevacizumab|"Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.~Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks."
1240579|NCT00118755|P2|Participant Flow|XELOX Q2W + Bevacizumab|"Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.~Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks."
1240580|NCT00118755|P1|Participant Flow|XELOX Q3W + Bevacizumab|"Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.~Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks."
1240581|NCT00118755|O2|Outcome|XELOX Q2W + Bevacizumab|"Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.~Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks."
1240582|NCT00118755|O1|Outcome|XELOX Q3W + Bevacizumab|"Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.~Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks."
1240583|NCT00118755|O2|Outcome|XELOX Q2W + Bevacizumab|"Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.~Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks."
1240584|NCT00118755|O1|Outcome|XELOX Q3W + Bevacizumab|"Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.~Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks."
1240585|NCT00118755|O2|Outcome|XELOX Q2W + Bevacizumab|"Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.~Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks."
1240586|NCT00118755|O1|Outcome|XELOX Q3W + Bevacizumab|"Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.~Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks."
1240587|NCT00118755|O2|Outcome|XELOX Q2W + Bevacizumab|"Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.~Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks."
1240588|NCT00118755|O1|Outcome|XELOX Q3W + Bevacizumab|"Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.~Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks."
1240589|NCT00118755|E2|Reported Event|XELOX Q2W + Bevacizumab|"Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.~Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks."
1240590|NCT00118755|E1|Reported Event|XELOX Q3W + Bevacizumab|"Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.~Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks."
1240592|NCT00118742|B2|Baseline|CellCept + Sirolimus|CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
1240593|NCT00118742|B1|Baseline|CellCept + CNI (Tacrolimus or Cyclosporine)|CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
1240594|NCT00118742|P2|Participant Flow|CellCept + Sirolimus|CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
1240595|NCT00118742|P1|Participant Flow|CellCept + CNI (Tacrolimus or Cyclosporine)|CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
1240596|NCT00118742|O2|Outcome|CellCept + Sirolimus|CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
1240597|NCT00118742|O1|Outcome|CellCept + CNI (Tacrolimus or Cyclosporine)|CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
1240598|NCT00118742|O2|Outcome|CellCept + Sirolimus|CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
1240599|NCT00118742|O1|Outcome|CellCept + CNI (Tacrolimus or Cyclosporine)|CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
1240600|NCT00118742|O2|Outcome|CellCept + Sirolimus|CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
1240601|NCT00118742|O1|Outcome|CellCept + CNI (Tacrolimus or Cyclosporine)|CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
1240602|NCT00118742|O2|Outcome|CellCept + Sirolimus|CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
1240603|NCT00118742|O1|Outcome|CellCept + CNI (Tacrolimus or Cyclosporine)|CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
1240604|NCT00118742|E2|Reported Event|CellCept + Sirolimus|CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
1240605|NCT00118742|E1|Reported Event|CellCept + CNI (Tacrolimus or Cyclosporine)|CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
1240606|NCT00118703|B3|Baseline|Total|Total of all reporting groups
1240607|NCT00118703|B2|Baseline|Fluticasone Furoate 110 µg QD|Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
1240608|NCT00118703|B1|Baseline|Placebo|Participants were instructed to self administer two sprays of placebo into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
1240609|NCT00118703|P2|Participant Flow|Fluticasone Furoate 110 µg QD|Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
1240610|NCT00118703|P1|Participant Flow|Placebo|Participants were instructed to self administer two sprays of placebo into each nostril once daily (QD) in the morning (ante meridian [AM]), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
1240611|NCT00118703|O2|Outcome|Fluticasone Furoate 110 µg QD|Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
1240612|NCT00118703|O1|Outcome|Placebo|Participants were instructed to self administer two sprays of placebo into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
1240613|NCT00118703|O2|Outcome|Fluticasone Furoate 110 µg QD|Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
1240614|NCT00118703|O1|Outcome|Placebo|Participants were instructed to self administer two sprays of placebo into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
1240615|NCT00118703|O2|Outcome|Fluticasone Furoate 110 µg QD|Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
1240616|NCT00118703|O1|Outcome|Placebo|Participants were instructed to self administer two sprays of placebo into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
1240617|NCT00118703|E2|Reported Event|Fluticasone Furoate 110 µg QD|Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
1240618|NCT00118703|E1|Reported Event|Placebo|Participants were instructed to self administer two sprays of placebo into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
1240619|NCT00118534|B3|Baseline|Total|Total of all reporting groups
1240620|NCT00118534|B2|Baseline|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240621|NCT00118534|B1|Baseline|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240622|NCT00118534|P2|Participant Flow|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240623|NCT00118534|P1|Participant Flow|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240624|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240625|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240626|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240627|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240628|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240629|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240630|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240631|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240632|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240633|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240634|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240635|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240636|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240637|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240638|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240639|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240640|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240641|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240642|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240643|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240644|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240645|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240646|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240647|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240648|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240649|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240650|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240651|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240652|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240653|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240654|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240655|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240656|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240657|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240658|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240659|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240660|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240661|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240662|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240663|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240664|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240665|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240666|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240667|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240668|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240669|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240670|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240671|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1241318|NCT00117312|B1|Baseline|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
1240672|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240673|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240674|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240675|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240676|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240677|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240678|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240679|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240680|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240681|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240682|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240683|NCT00118534|O1|Outcome|Integrated Care|Integration of Smoking Cessation therapy with PTSD therapy.
1240684|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240685|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240686|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240687|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240688|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240689|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240690|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240691|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240692|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240693|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240694|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240695|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1241384|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1240696|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240697|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240698|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240699|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240700|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240701|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240702|NCT00118534|E2|Reported Event|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
1240703|NCT00118534|E1|Reported Event|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
1240704|NCT00118430|B4|Baseline|Total|Total of all reporting groups
1240705|NCT00118430|B3|Baseline|No Treatment|Participants without depression group
1240706|NCT00118430|B2|Baseline|Usual Care|"Treatment as usual group~Usual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group."
1240707|NCT00118430|B1|Baseline|Stepped Care|"Stepped care group~Stepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.~Antidepressants: Participants will be assigned to optimization of venlafaxine, duloxetine, fluoxetine, sertraline, citalopram, paroxetine, or nortriptyline."
1240708|NCT00118430|P3|Participant Flow|No Treatment|Participants without depression group
1240709|NCT00118430|P2|Participant Flow|Usual Care|"Treatment as usual group~Usual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group."
1240749|NCT00118404|O2|Outcome|Continuation Phase Cognitive Therapy|"Participants received acute phase and continuation phase cognitive therapy~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months."
1240750|NCT00118404|O1|Outcome|Continuation Phase Fluoxetine|"Participants received acute phase cognitive therapy and continuation phase pill placebo~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months."
1241319|NCT00117312|P4|Participant Flow|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
1240710|NCT00118430|P1|Participant Flow|Stepped Care|"Stepped care group~Stepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly with a physician-investigator to review cases, the physician-investigator will be available at all times to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response~Antidepressants: Participants will be assigned to one of the following antidepressant regimens: venlafaxine (37.5 mg, increased to 75, 150, 225 mg"
1240711|NCT00118430|O2|Outcome|Usual Care|"Treatment as usual group~Usual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group."
1240712|NCT00118430|O1|Outcome|Stepped Care|"Stepped care group~Stepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.~Antidepressants: Participants will be assigned to optimization of venlafaxine, duloxetine, fluoxetine, sertraline, citalopram, paroxetine, or nortriptyline."
1240713|NCT00118430|O3|Outcome|No Treatment|Participants without depression group
1240714|NCT00118430|O2|Outcome|Usual Care|"Treatment as usual group~Usual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group."
1240715|NCT00118430|O1|Outcome|Stepped Care|"Stepped care group~Stepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.~Antidepressants: Participants will be assigned to optimization of venlafaxine, duloxetine, fluoxetine, sertraline, citalopram, paroxetine, or nortriptyline."
1240716|NCT00118430|O3|Outcome|No Treatment|Participants without depression group
1240717|NCT00118430|O2|Outcome|Usual Care|"Treatment as usual group~Usual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group."
1240741|NCT00118404|P1|Participant Flow|Continuation Phase Fluoxetine|"Participants received acute phase cognitive therapy and continuation phase pill placebo~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months."
1240742|NCT00118404|O3|Outcome|Continuation Phase Pill Placebo|"Participants received acute phase cognitive therapy and continuation phase fluoxetine~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months."
1240718|NCT00118430|O1|Outcome|Stepped Care|"Stepped care group~Stepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.~Antidepressants: Participants will be assigned to optimization of venlafaxine, duloxetine, fluoxetine, sertraline, citalopram, paroxetine, or nortriptyline."
1240719|NCT00118430|O3|Outcome|No Treatment|Participants without depression group
1240720|NCT00118430|O2|Outcome|Usual Care|"Treatment as usual group~Usual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group."
1240721|NCT00118430|O1|Outcome|Stepped Care|"Stepped care group~Stepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.~Antidepressants: Participants will be assigned to optimization of venlafaxine, duloxetine, fluoxetine, sertraline, citalopram, paroxetine, or nortriptyline."
1240722|NCT00118430|E2|Reported Event|Usual Care|"Treatment as usual group~Usual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group."
1240751|NCT00118404|E3|Reported Event|Continuation Phase Pill Placebo|"Participants received acute phase cognitive therapy and continuation phase fluoxetine~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months."
1253267|NCT00083174|O1|Outcome|Exemestane|one 25 mg tablet daily in am
1240723|NCT00118430|E1|Reported Event|Stepped Care|"Stepped care group~Stepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.~Antidepressants: Participants will be assigned to optimization of venlafaxine, duloxetine, fluoxetine, sertraline, citalopram, paroxetine, or nortriptyline."
1240724|NCT00118417|B1|Baseline|All Participants|
1240725|NCT00118417|P2|Participant Flow|Sertraline / + Placebo / Cognitive Behavior Therapy Augment.|In Phase 1, this group will receive a moderate dose of sertraline (or escitalopram, an equivalent SSRI); In Phase 2, this group will receive their SSRI plus a placebo; In Phase 3, this group will receive their SSRI plus cognitive behavioral therapy (CBT)
1240726|NCT00118417|P1|Participant Flow|Sertraline / Increased Dose / Medication Optimization|In Phase 1, this group will receive a moderate dose of sertraline (or escitalopram, an equivalent SSRI); In Phase 2, this group will receive an increased dosage of their SSRI; In Phase 3, this group will receive medication optimization, which includes an SSRI and clonazepam
1240727|NCT00118417|O2|Outcome|Augmented Cognitive Behavior Therapy|This group will receive sertraline or escitalopram with cognitive behavioral therapy (CBT)
1240728|NCT00118417|O1|Outcome|Medication Optimization|This group will receive medication optimization, which includes sertraline or escitalopram with clonazepam
1240729|NCT00118417|O2|Outcome|Sertraline Plus Placebo|This group will receive sertraline or escitalopram with a placebo
1240730|NCT00118417|O1|Outcome|Increased Sertraline|This group will receive an increased dosage of sertraline or escitalopram
1240731|NCT00118417|O1|Outcome|Moderate Sertraline Treatment|This group will receive moderate sertraline or escitalopram treatment
1240732|NCT00118417|E3|Reported Event|Phase III: Cont. Medication Plus CBT OR SSRI and Clonazepam|
1240733|NCT00118417|E2|Reported Event|Phase II: Cont. SSRI Plus Placebo OR Increased Dose SSRI Alone|
1240734|NCT00118417|E1|Reported Event|Phase I: Sertraline|In Phase 1, this group will receive a moderate dose of sertraline (or escitalopram, an equivalent SSRI).
1240735|NCT00118404|B4|Baseline|Total|Total of all reporting groups
1240736|NCT00118404|B3|Baseline|Continuation Phase Pill Placebo|"Participants received acute phase cognitive therapy and continuation phase fluoxetine~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months."
1240737|NCT00118404|B2|Baseline|Continuation Phase Cognitive Therapy|"Participants received acute phase and continuation phase cognitive therapy~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months."
1240738|NCT00118404|B1|Baseline|Continuation Phase Fluoxetine|"Participants received acute phase cognitive therapy and continuation phase pill placebo~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months."
1240739|NCT00118404|P3|Participant Flow|Continuation Phase Pill Placebo|"Participants received acute phase cognitive therapy and continuation phase fluoxetine~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months."
1240740|NCT00118404|P2|Participant Flow|Continuation Phase Cognitive Therapy|"Participants received acute phase and continuation phase cognitive therapy~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months."
1252080|NCT00087672|E1|Reported Event|CC-5013|10 mg orally daily
1240743|NCT00118404|O2|Outcome|Continuation Phase Cognitive Therapy|"Participants received acute phase and continuation phase cognitive therapy~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months."
1240744|NCT00118404|O1|Outcome|Continuation Phase Fluoxetine|"Participants received acute phase cognitive therapy and continuation phase pill placebo~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months."
1240745|NCT00118404|O3|Outcome|Continuation Phase Pill Placebo|"Participants received acute phase cognitive therapy and continuation phase fluoxetine~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months."
1240746|NCT00118404|O2|Outcome|Continuation Phase Cognitive Therapy|"Participants received acute phase and continuation phase cognitive therapy~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months."
1240747|NCT00118404|O1|Outcome|Continuation Phase Fluoxetine|"Participants received acute phase cognitive therapy and continuation phase pill placebo~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months."
1240748|NCT00118404|O3|Outcome|Continuation Phase Pill Placebo|"Participants received acute phase cognitive therapy and continuation phase fluoxetine~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months."
1241062|NCT00117806|O1|Outcome|Supported Employment|Supported Employment Vocational Rehabilitation: SCI-VIP: supported employment implemented for veterans with spinal cord injury.
1240752|NCT00118404|E2|Reported Event|Continuation Phase Cognitive Therapy|"Participants received acute phase and continuation phase cognitive therapy~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months."
1240753|NCT00118404|E1|Reported Event|Continuation Phase Fluoxetine|"Participants received acute phase cognitive therapy and continuation phase pill placebo~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months."
1240754|NCT00118378|B3|Baseline|Total|Total of all reporting groups
1240755|NCT00118378|B2|Baseline|Placebo|Participants will take placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
1240756|NCT00118378|B1|Baseline|Modafinil|Participants will take modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.
1240757|NCT00118378|P2|Participant Flow|Placebo|Participants will take placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
1240758|NCT00118378|P1|Participant Flow|Modafinil|Participants will take modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.
1240759|NCT00118378|O2|Outcome|Placebo|Participants randomized to placebo for 4 weeks.
1240760|NCT00118378|O1|Outcome|Modafinil|Participants randomized to modafinil for 4 weeks.
1240761|NCT00118378|O2|Outcome|Placebo|Participants randomized to placebo for 4 weeks.
1240762|NCT00118378|O1|Outcome|Modafinil|Participants randomized to modafinil for 4 weeks.
1240763|NCT00118378|O2|Outcome|Placebo|Participants randomized to placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
1240764|NCT00118378|O1|Outcome|Modafinil|Participants randomized to modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.
1240765|NCT00118378|O2|Outcome|Placebo|Participants randomized to placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
1240766|NCT00118378|O1|Outcome|Modafinil|Participants randomized to modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.
1240767|NCT00118378|E2|Reported Event|Placebo|Participants will take placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
1240768|NCT00118378|E1|Reported Event|Modafinil|Participants will take modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.
1240769|NCT00118365|B3|Baseline|Total|Total of all reporting groups
1240770|NCT00118365|B2|Baseline|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
1240771|NCT00118365|B1|Baseline|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
1240772|NCT00118365|P2|Participant Flow|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
1240773|NCT00118365|P1|Participant Flow|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
1240774|NCT00118365|O2|Outcome|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
1240775|NCT00118365|O1|Outcome|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
1240776|NCT00118365|O2|Outcome|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
1240777|NCT00118365|O1|Outcome|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
1240778|NCT00118365|O2|Outcome|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
1240779|NCT00118365|O1|Outcome|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
1240780|NCT00118365|O2|Outcome|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
1240781|NCT00118365|O1|Outcome|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
1240782|NCT00118365|O2|Outcome|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
1240783|NCT00118365|O1|Outcome|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
1240784|NCT00118365|O2|Outcome|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
1240785|NCT00118365|O1|Outcome|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
1240786|NCT00118365|O4|Outcome|Placebo - AA/GA|"Patients with AA or GA genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
1240787|NCT00118365|O3|Outcome|Placebo - GG|"Patients with GG genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
1240788|NCT00118365|O2|Outcome|DFMO + Sulindac - AA/GA|"Patients with AA or GA genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
1240789|NCT00118365|O1|Outcome|DFMO + Sulindac - GG|"Patients with GG genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
1240790|NCT00118365|O4|Outcome|Placebo - AA/GA|"Patients with AA or GA genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
1240791|NCT00118365|O3|Outcome|Placebo - GG|"Patients with GG genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
1240792|NCT00118365|O2|Outcome|DFMO + Sulindac - AA/GA|"Patients with AA or GA genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
1240793|NCT00118365|O1|Outcome|DFMO + Sulindac - GG|"Patients with GG genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
1240891|NCT00118157|O1|Outcome|Arm 1|"Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28.~lapatinib ditosylate: Given orally~tamoxifen citrate: Given orally"
1240794|NCT00118365|O4|Outcome|Placebo - AA/GA|"Patients with AA or GA genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
1240795|NCT00118365|O3|Outcome|Placebo - GG|"Patients with GG genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
1240796|NCT00118365|O2|Outcome|DFMO + Sulindac - AA/GA|"Patients with AA or GA genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
1240797|NCT00118365|O1|Outcome|DFMO + Sulindac - GG|"Patients with GG genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
1240798|NCT00118365|O4|Outcome|Placebo - AA/GA|"Patients with AA or GA genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
1240799|NCT00118365|O3|Outcome|Placebo - GG|"Patients with GG genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
1240800|NCT00118365|O2|Outcome|DFMO + Sulindac - AA/GA|"Patients with AA or GA genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
1240801|NCT00118365|O1|Outcome|DFMO + Sulindac - GG|"Patients with GG genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
1240802|NCT00118365|O2|Outcome|ODC1 GG|Patients with GG genotype
1240803|NCT00118365|O1|Outcome|ODC1 AA/GA|Patients with AA or GA genotype
1240804|NCT00118365|O2|Outcome|ODC1 GG|Patients with GG genotype
1240805|NCT00118365|O1|Outcome|ODC1 AA/GA|Patients with AA or GA genotype
1240806|NCT00118365|O2|Outcome|ODC1 GG|Patients with GG genotype
1240807|NCT00118365|O1|Outcome|ODC1 AA/GA|Patients with AA or GA genotype
1253268|NCT00083174|O2|Outcome|Placebo|one tablet daily in am
1240808|NCT00118365|O2|Outcome|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
1240809|NCT00118365|O1|Outcome|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
1240810|NCT00118365|O4|Outcome|Placebo + Spd:Spm Nonresponders|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~Spd:Spm nonresponder = spermidine-to-spermine ratio at 36-month increased, or decreased by < 30% from baseline"
1240811|NCT00118365|O3|Outcome|Placebo + Spd:Spm Responders|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~SpSpd:Spm Responder = spermidine-to-spermine ratio at 36-month are decreased by >=30% from baseline"
1240812|NCT00118365|O2|Outcome|Eflornithine and Sulindac + Spd:Spm Nonresponders|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~Spd:Spm nonresponder = spermidine-to-spermine ratio at 36-month increased, or decreased by < 30% from baseline"
1240813|NCT00118365|O1|Outcome|Eflornithine and Sulindac + Spd:Spm Responders|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~Spd:Spm Responder = spermidine-to-spermine ratio at 36-month are decreased by >=30% from baseline"
1240814|NCT00118365|O4|Outcome|Placebo + Putrescine Nonresponders|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~Putrescine nonresponder = Putrescine values at 36-month are increased, or decreased by < 30% from baseline"
1240815|NCT00118365|O3|Outcome|Placebo + Putrescine Responders|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~Putrescine responder = Putrescine values at 36-month are decreased by >=30% from baseline"
1240816|NCT00118365|O2|Outcome|Eflornithine and Sulindac + Putrescine Nonresponders|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~Putrescine nonresponder = Putrescine values at 36-month are increased, or decreased by < 30% from baseline"
1240835|NCT00118365|O1|Outcome|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
1240817|NCT00118365|O1|Outcome|Eflornithine and Sulindac + Putrescine Responders|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~Putrescine responder = Putrescine values at 36-month are decreased by >=30% from baseline"
1240818|NCT00118365|O4|Outcome|Placebo + PGE2 Nonresponders|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~PGE2 nonresponder = PGE2 values at 36-month are increased, or decreased by < 30% from baseline"
1240819|NCT00118365|O3|Outcome|Placebo + PGE2 Responders|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~PGE2 Responder = PGE2 values at 36-month are decreased by >=30% in PGE2 values from baseline"
1240820|NCT00118365|O2|Outcome|Eflornithine and Sulindac + PGE2 Nonresponders|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~PGE2 nonresponder = PGE2 values at 36-month are increased, or decreased by < 30% from baseline"
1240821|NCT00118365|O1|Outcome|Eflornithine and Sulindac + PGE2 Responders|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~PGE2 Responder = PGE2 values at 36-month are decreased by >=30% in PGE2 values from baseline"
1240822|NCT00118365|O4|Outcome|Placebo + High Spd:Spm at Baseline|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~baseline spermidine-to-spermine ratio is above median"
1240823|NCT00118365|O3|Outcome|Placebo + Low Spd:Spm at Baseline|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~baseline spermidine-to-spermine ratio is below median"
1240824|NCT00118365|O2|Outcome|Eflornithine and Sulindac + High Spd:Spm at Baseline|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~baseline spermidine-to-spermine ratio is above the median"
1240825|NCT00118365|O1|Outcome|Eflornithine and Sulindac + Low Spd:Spm at Baseline|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~baseline spermidine-to-spermine ratio is below the median"
1240826|NCT00118365|O4|Outcome|Placebo + High Putrescine at Baseline|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~baseline Putrescine value is above median"
1240827|NCT00118365|O3|Outcome|Placebo + Low Putrescine at Baseline|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~baseline Putrescine value is below median"
1240828|NCT00118365|O2|Outcome|Eflornithine and Sulindac + High Putrescine at Baseline|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~baseline Putrescine values is above the median"
1240829|NCT00118365|O1|Outcome|Eflornithine and Sulindac + Low Putrescine at Baseline|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~baseline Putrescine values is below the median"
1240830|NCT00118365|O4|Outcome|Placebo + High PGE2 at Baseline|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~baseline PGE2 value is above median"
1240831|NCT00118365|O3|Outcome|Placebo + Low PGE2 at Baseline|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~baseline PGE2 value is below median"
1240832|NCT00118365|O2|Outcome|Eflornithine and Sulindac + High PGE2 at Baseline|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~baseline PGE2 values is above the median"
1240833|NCT00118365|O1|Outcome|Eflornithine and Sulindac + Low PGE2 at Baseline|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~baseline PGE2 values is below the median"
1240834|NCT00118365|O2|Outcome|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
1240888|NCT00118248|E1|Reported Event|All Patients|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1240836|NCT00118365|E2|Reported Event|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
1240837|NCT00118365|E1|Reported Event|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
1240838|NCT00118352|B4|Baseline|Total|Total of all reporting groups
1240839|NCT00118352|B3|Baseline|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
1240840|NCT00118352|B2|Baseline|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
1240841|NCT00118352|B1|Baseline|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
1240842|NCT00118352|P3|Participant Flow|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation~NOTE: No subjects were enrolled at this dose level as the escalation rule was not met."
1240903|NCT00118131|O1|Outcome|Docetaxel and Cisplatin|"A cycle is defined as an interval of 28 days.~Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).~Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).~Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15."
1240843|NCT00118352|P2|Participant Flow|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation~NOTE: No subjects were enrolled at this dose level as the escalation rule was not met."
1240844|NCT00118352|P1|Participant Flow|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
1240845|NCT00118352|O3|Outcome|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
1240846|NCT00118352|O2|Outcome|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
1240847|NCT00118352|O1|Outcome|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
1240848|NCT00118352|O3|Outcome|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
1240849|NCT00118352|O2|Outcome|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
1240850|NCT00118352|O1|Outcome|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
1240889|NCT00118157|B1|Baseline|Arm 1|"Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28.~lapatinib ditosylate: Given orally~tamoxifen citrate: Given orally"
1240851|NCT00118352|O3|Outcome|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
1240852|NCT00118352|O2|Outcome|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
1240853|NCT00118352|O1|Outcome|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
1240854|NCT00118352|O3|Outcome|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
1240855|NCT00118352|O2|Outcome|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
1240904|NCT00118131|O1|Outcome|Docetaxel and Cisplatin|"A cycle is defined as an interval of 28 days.~Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).~Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).~Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15."
1240856|NCT00118352|O1|Outcome|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
1240857|NCT00118352|O3|Outcome|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
1240858|NCT00118352|O2|Outcome|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
1240859|NCT00118352|O1|Outcome|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
1240860|NCT00118352|O3|Outcome|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
1240861|NCT00118352|O2|Outcome|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
1240862|NCT00118352|O1|Outcome|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
1240863|NCT00118352|O3|Outcome|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
1240864|NCT00118352|O2|Outcome|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
1240865|NCT00118352|O1|Outcome|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
1240866|NCT00118352|E3|Reported Event|Dose Level 3 (60mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
1240867|NCT00118352|E2|Reported Event|Dose Level 2 (40mg Total Dose Campath)|"Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Alemtuzumab: Given IV~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
1240868|NCT00118352|E1|Reported Event|Dose Level 1 (No Campath)|"Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0.~Total-body irradiation: Undergo low-dose total-body irradiation~Fludarabine phosphate: Given IV~Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation"
1240869|NCT00118287|B1|Baseline|Treatment (Chemotherapy, Chemoprotection)|"Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~azacitidine: Given SC or IV~etanercept: Given SC"
1240942|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240870|NCT00118287|P1|Participant Flow|Treatment (Chemotherapy, Chemoprotection)|"Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~azacitidine: Given SC or IV~etanercept: Given SC"
1240871|NCT00118287|O1|Outcome|Treatment (Chemotherapy, Chemoprotection)|"Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~azacitidine: Given SC or IV~etanercept: Given SC"
1240872|NCT00118287|E1|Reported Event|Treatment (Chemotherapy, Chemoprotection)|"Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~azacitidine: Given SC or IV~etanercept: Given SC"
1240873|NCT00118248|B3|Baseline|Total|Total of all reporting groups
1240874|NCT00118248|B2|Baseline|Differentiated Thyroid Carcinoma|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1240875|NCT00118248|B1|Baseline|Advanced Medullary Thyroid Carcinoma Group|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1240876|NCT00118248|P2|Participant Flow|Differentiated Thyroid Carcinoma|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1240877|NCT00118248|P1|Participant Flow|Advanced Medullary Thyroid Carcinoma Group|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1240878|NCT00118248|O2|Outcome|Differentiated Thyroid Carcinoma|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1240879|NCT00118248|O1|Outcome|Advanced Medullary Thyroid Carcinoma Group|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1240880|NCT00118248|O2|Outcome|Differentiated Thyroid Carcinoma|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1240881|NCT00118248|O1|Outcome|Advanced Medullary Thyroid Carcinoma Group|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1240882|NCT00118248|O2|Outcome|Differentiated Thyroid Carcinoma|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1240883|NCT00118248|O1|Outcome|Advanced Medullary Thyroid Carcinoma Group|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1240884|NCT00118248|O2|Outcome|Differentiated Thyroid Carcinoma|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1240885|NCT00118248|O1|Outcome|Advanced Medullary Thyroid Carcinoma Group|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1240886|NCT00118248|O2|Outcome|Differentiated Thyroid Carcinoma|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1240887|NCT00118248|O1|Outcome|Advanced Medullary Thyroid Carcinoma Group|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1240890|NCT00118157|P1|Participant Flow|Arm 1|"Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28.~lapatinib ditosylate: Given orally~tamoxifen citrate: Given orally"
1240892|NCT00118157|E1|Reported Event|Arm 1|"Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28.~lapatinib ditosylate: Given orally~tamoxifen citrate: Given orally"
1240893|NCT00118144|B1|Baseline|Arm 1|Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.
1240894|NCT00118144|P1|Participant Flow|Arm I|Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.
1240895|NCT00118144|O1|Outcome|Arm I|"Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.~bortezomib: Given IV"
1240896|NCT00118144|O1|Outcome|Arm 1|Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.
1240897|NCT00118144|O1|Outcome|Arm 1|Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.
1240898|NCT00118144|E1|Reported Event|Arm I|Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.
1240899|NCT00118131|B1|Baseline|Docetaxel and Cisplatin|"A cycle is defined as an interval of 28 days.~Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).~Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).~Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15."
1240900|NCT00118131|P1|Participant Flow|Docetaxel and Cisplatin|"A cycle is defined as an interval of 28 days.~Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).~Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).~Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15."
1240901|NCT00118131|O1|Outcome|Docetaxel and Cisplatin|"A cycle is defined as an interval of 28 days.~Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).~Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).~Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15."
1240902|NCT00118131|O1|Outcome|Docetaxel and Cisplatin|"A cycle is defined as an interval of 28 days.~Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).~Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).~Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15."
1240905|NCT00118131|E1|Reported Event|Docetaxel and Cisplatin|"A cycle is defined as an interval of 28 days.~Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).~Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).~Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15."
1240906|NCT00118092|B1|Baseline|Treatment (Tanespimycin)|Patients receive 300 mg/m^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. > Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1240907|NCT00118092|P1|Participant Flow|Treatment (Tanespimycin)|Patients receive 300 mg/m^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. > Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1240908|NCT00118092|O1|Outcome|Treatment (Tanespimycin)|"Patients receive 300 mg/m^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15.~> Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
1240909|NCT00118092|O1|Outcome|Treatment (Tanespimycin)|Patients receive 300 mg/m^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. > Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1240910|NCT00118092|O1|Outcome|Treatment (Tanespimycin)|Patients receive 300 mg/m^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. > Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1240911|NCT00118092|O1|Outcome|Treatment (Tanespimycin)|"Patients receive 300 mg/m^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15.~> Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
1240912|NCT00118092|O1|Outcome|Treatment (Tanespimycin)|Patients receive 300 mg/m^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. > Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1240913|NCT00118092|E1|Reported Event|Treatment (Tanespimycin)|Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1240914|NCT00118053|B1|Baseline|Docetaxel, Carboplatin and Trastuzumab|"A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.~Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.~If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks."
1240915|NCT00118053|P1|Participant Flow|Docetaxel, Carboplatin and Trastuzumab|"A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.~Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.~If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks."
1241027|NCT00117949|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
1240916|NCT00118053|O1|Outcome|Docetaxel, Carboplatin and Trastuzumab|"A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.~Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.~If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks."
1240917|NCT00118053|O1|Outcome|Docetaxel, Carboplatin and Trastuzumab|"A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.~Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.~If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks."
1240918|NCT00118053|O1|Outcome|Docetaxel, Carboplatin and Trastuzumab|"A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.~Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.~If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks."
1240943|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
1240944|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1241320|NCT00117312|P3|Participant Flow|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
1240919|NCT00118053|O1|Outcome|Docetaxel, Carboplatin and Trastuzumab|"A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.~Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.~If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks."
1240920|NCT00118053|E1|Reported Event|Docetaxel, Carboplatin and Trastuzumab|"A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.~Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.~If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks."
1240921|NCT00118040|B4|Baseline|Total|Total of all reporting groups
1240922|NCT00118040|B3|Baseline|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240923|NCT00118040|B2|Baseline|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240924|NCT00118040|B1|Baseline|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240925|NCT00118040|P3|Participant Flow|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240926|NCT00118040|P2|Participant Flow|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240927|NCT00118040|P1|Participant Flow|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240928|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240929|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240930|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240931|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
1241028|NCT00117949|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
1241029|NCT00117949|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
1240932|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240933|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240934|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240935|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
1240936|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240937|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240938|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240939|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
1240940|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240941|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240945|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240946|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240947|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
1240948|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240949|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240950|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240951|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
1240952|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240953|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240954|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240955|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
1240956|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240957|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240958|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240959|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
1241030|NCT00117949|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
1241031|NCT00117949|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
1240960|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240961|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240962|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240963|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
1240964|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240965|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240966|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240967|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
1240968|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240969|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240970|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240971|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
1240972|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240973|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240974|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240975|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
1240976|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240977|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240978|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240979|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
1240980|NCT00118040|O4|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
1240981|NCT00118040|O3|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240982|NCT00118040|O2|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240983|NCT00118040|O1|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
1240984|NCT00118040|E3|Reported Event|Arm III (Placebo)|"Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.~laboratory biomarker analysis: Correlative studies~placebo: Given orally~therapeutic conventional surgery: Undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.~pharmacological study: Correlative studies"
1240985|NCT00118040|E2|Reported Event|Arm II (Higher Dose Genistein)|"Patients receive oral genistein as in arm I but at a higher dose. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.~genistein: Given orally~laboratory biomarker analysis: Correlative studies~therapeutic conventional surgery: Undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.~pharmacological study: Correlative studies"
1241032|NCT00117949|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
1241033|NCT00117949|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
1240986|NCT00118040|E1|Reported Event|Arm I (Lower Dose Genistein)|"Patients receive oral genistein twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.~genistein: Given orally~laboratory biomarker analysis: Correlative studies~therapeutic conventional surgery: Undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.~pharmacological study: Correlative studies"
1240987|NCT00117988|B1|Baseline|17-AAG|17-N-allylamino-17-demethoxygeldanamycin (17-AAG) 220 mg/m^2 intravenous (IV) over 1 hour on days 1, 4, 8, and 11, repeated every 21 days
1240988|NCT00117988|P1|Participant Flow|17-AAG|17-N-allylamino-17-demethoxygeldanamycin (17-AAG) 220 mg/m^2 intravenous (IV) over 1 hour on days 1, 4, 8, and 11, repeated every 21 days
1240989|NCT00117988|O1|Outcome|17-AAG|17-N-allylamino-17-demethoxygeldanamycin (17-AAG) 220 mg/m^2 intravenous (IV) over 1 hour on days 1, 4, 8, and 11, repeated every 21 days
1240990|NCT00117988|E1|Reported Event|17-AAG|17-N-allylamino-17-demethoxygeldanamycin (17-AAG) 220 mg/m^2 intravenous (IV) over 1 hour on days 1, 4, 8, and 11, repeated every 21 days
1240991|NCT00117962|B3|Baseline|Total|Total of all reporting groups
1240992|NCT00117962|B2|Baseline|Std Tx + Pemetrexed and Cetuximab|Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
1240993|NCT00117962|B1|Baseline|Std Tx + Pemetrexed|Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
1240994|NCT00117962|P2|Participant Flow|Std Tx + Pemetrexed and Cetuximab|Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
1240995|NCT00117962|P1|Participant Flow|Std Tx + Pemetrexed|Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
1240996|NCT00117962|O2|Outcome|Std Tx + Pemetrexed and Cetuximab|Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
1240997|NCT00117962|O1|Outcome|Std Tx + Pemetrexed|Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
1240998|NCT00117962|O2|Outcome|Std Tx + Pemetrexed and Cetuximab|Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
1240999|NCT00117962|O1|Outcome|Std Tx + Pemetrexed|Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
1241000|NCT00117962|O2|Outcome|Std Tx + Pemetrexed and Cetuximab|Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
1241001|NCT00117962|O1|Outcome|Std Tx + Pemetrexed|Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
1241002|NCT00117962|O2|Outcome|Std Tx + Pemetrexed and Cetuximab|Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
1241003|NCT00117962|O1|Outcome|Std Tx + Pemetrexed|Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
1241004|NCT00117962|E2|Reported Event|Std Tx + Pemetrexed and Cetuximab|Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
1241005|NCT00117962|E1|Reported Event|Std Tx + Pemetrexed|Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
1241006|NCT00117949|B5|Baseline|Total|Total of all reporting groups
1241007|NCT00117949|B4|Baseline|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
1241008|NCT00117949|B3|Baseline|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
1241009|NCT00117949|B2|Baseline|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
1241010|NCT00117949|B1|Baseline|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
1241011|NCT00117949|P4|Participant Flow|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
1241012|NCT00117949|P3|Participant Flow|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
1241013|NCT00117949|P2|Participant Flow|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
1241014|NCT00117949|P1|Participant Flow|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
1241015|NCT00117949|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
1241016|NCT00117949|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
1241017|NCT00117949|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
1241018|NCT00117949|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
1241019|NCT00117949|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
1241020|NCT00117949|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
1241021|NCT00117949|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
1241022|NCT00117949|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
1241023|NCT00117949|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
1241024|NCT00117949|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
1241025|NCT00117949|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
1241026|NCT00117949|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
1241047|NCT00117845|B1|Baseline|Denileukin Diftitox in ATL|Denileukin Diftitox in adult T-cell leukemia (ATL) Patients will be treated with Denileukin Diftitox 9 mcg/kg/d intravenously for 5 days every 2 weeks.
1241048|NCT00117845|P1|Participant Flow|Denileukin Diftitox in ATL|Denileukin Diftitox in adult T-cell leukemia (ATL) Patients will be treated with Denileukin Diftitox 9 mcg/kg/d intravenously for 5 days every 2 weeks.
1241049|NCT00117845|O1|Outcome|Denileukin Diftitox in ATL|Denileukin Diftitox in adult T-cell leukemia (ATL) Patients will be treated with Denileukin Diftitox 9 mcg/kg/d intravenously for 5 days every 2 weeks.
1241050|NCT00117845|O1|Outcome|Denileukin Diftitox in ATL|Denileukin Diftitox in adult T-cell leukemia (ATL) Patients will be treated with Denileukin Diftitox 9 mcg/kg/d intravenously for 5 days every 2 weeks.
1241051|NCT00117845|E1|Reported Event|Denileukin Diftitox in ATL|Denileukin Diftitox in adult T-cell leukemia (ATL) Patients will be treated with Denileukin Diftitox 9 mcg/kg/d intravenously for 5 days every 2 weeks.
1241052|NCT00117806|B3|Baseline|Total|Total of all reporting groups
1241053|NCT00117806|B2|Baseline|Treatment As Usual|Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
1241054|NCT00117806|B1|Baseline|Supported Employment|"SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury~Evidence-Based Supported Employment Vocational Rehabilitation: SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury."
1241055|NCT00117806|P2|Participant Flow|Treatment As Usual|Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
1241056|NCT00117806|P1|Participant Flow|Supported Employment|"SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury~Evidence-Based Supported Employment Vocational Rehabilitation: SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury."
1241057|NCT00117806|O2|Outcome|Arm 2|Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
1241058|NCT00117806|O1|Outcome|Arm 1|"SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury~Evidence-Based Supported Employment Vocational Rehabilitation: SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury."
1241059|NCT00117806|O2|Outcome|Treatment As Usual|Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
1241060|NCT00117806|O1|Outcome|Supported Employment|"SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury~Evidence-Based Supported Employment Vocational Rehabilitation: SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury."
1241061|NCT00117806|O2|Outcome|Treatment As Usual|Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
1253269|NCT00083174|O1|Outcome|Exemestane|one 25 mg tablet daily in am
1241063|NCT00117806|E2|Reported Event|Treatment As Usual|Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
1241064|NCT00117806|E1|Reported Event|Supported Employment|"SCI-VIP: supported employment implemented for veterans with spinal cord injury~Supported Employment Vocational Rehabilitation: SCI-VIP: supported employment implemented for veterans with spinal cord injury."
1241065|NCT00117793|B1|Baseline|Entire Study Population|Includes participants randomized to receive PIN first and VASS first.
1241066|NCT00117793|P1|Participant Flow|Entire Study Population|"This is a randomized cross-over study. Each participant wore both study prostheses: (1) a total surface bearing socket with a vacuum-assisted suspension system (VASS) and (2) a modified patellar tendon bearing socket with a pin lock suspension system (PIN).~Subjects were randomized, provided with one of two study prostheses, and asked to wear it for three weeks. Data was then collected during laboratory visit one, and, following one more week of wearing the first study prosthesis, during laboratory visit two. Participants were then provided with the second study intervention and asked to wear it for three weeks. Data was then collected during laboratory visit three, and, following one more week of wearing the second study intervention, during laboratory visit four.~Data was not collected on the order in which participants received each study intervention"
1241067|NCT00117793|O2|Outcome|VASS Suspension|A total surface bearing socket with a vacuum-assisted suspension system (VASS).
1241068|NCT00117793|O1|Outcome|PIN Suspension|A modified patellar tendon bearing socket with a pin lock suspension system (PIN)
1241069|NCT00117793|O2|Outcome|VASS Suspension|A total surface bearing socket with a vacuum-assisted suspension system (VASS).
1241070|NCT00117793|O1|Outcome|PIN Suspension|A modified patellar tendon bearing socket with a pin lock suspension system (PIN)
1241071|NCT00117793|O2|Outcome|VASS Suspension|A total surface bearing socket with a vacuum-assisted suspension system (VASS).
1241072|NCT00117793|O1|Outcome|PIN Suspension|A modified patellar tendon bearing socket with a pin lock suspension system (PIN)
1241073|NCT00117793|O2|Outcome|VASS Suspension|A total surface bearing socket with a vacuum-assisted suspension system (VASS).
1241074|NCT00117793|O1|Outcome|PIN Suspension|A modified patellar tendon bearing socket with a pin lock suspension system (PIN)
1241075|NCT00117793|O2|Outcome|VASS Suspension|A total surface bearing socket with a vacuum-assisted suspension system (VASS).
1241076|NCT00117793|O1|Outcome|PIN Suspension|A modified patellar tendon bearing socket with a pin lock suspension system (PIN)
1241077|NCT00117793|O2|Outcome|VASS Suspension|A total surface bearing socket with a vacuum-assisted suspension system (VASS).
1241078|NCT00117793|O1|Outcome|PIN Suspension|A modified patellar tendon bearing socket with a pin lock suspension system (PIN)
1241079|NCT00117793|E1|Reported Event|Entire Study Population|Includes participants randomized to receive PIN first and VASS first.
1241080|NCT00117676|B3|Baseline|Total|Total of all reporting groups
1241081|NCT00117676|B2|Baseline|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241385|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241082|NCT00117676|B1|Baseline|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added emtricitabine (FTC) to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241083|NCT00117676|P2|Participant Flow|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their treatment regimen in the open-label period.
1241084|NCT00117676|P1|Participant Flow|TDF-TDF|Tenofovir disoproxil fumarate (TDF) 300 mg plus placebo to match adefovir dipivoxil (ADV) (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added emtricitabine (FTC; as part of FTC 200 mg/TDF 300 mg fixed-dose combination (FDC) tablet) to their treatment regimen in the open-label period.
1241085|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241086|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241087|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241088|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241089|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241090|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241091|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241092|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241093|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241321|NCT00117312|P2|Participant Flow|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
1241094|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241095|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241096|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241097|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241098|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241099|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241100|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241101|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241102|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241103|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241104|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241105|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241106|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241107|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241108|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241109|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241110|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241111|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241112|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241113|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241114|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241115|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241116|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241117|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241118|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241119|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241322|NCT00117312|P1|Participant Flow|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
1241323|NCT00117312|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
1241120|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241121|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241122|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241123|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241124|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241125|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241126|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241127|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241128|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241129|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241130|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241131|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241132|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241133|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241386|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241134|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241135|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241136|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241137|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241138|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241139|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241140|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241141|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241142|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241143|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241144|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241145|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241146|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241147|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241148|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241149|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241150|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241151|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241152|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241153|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241154|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241155|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241156|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241157|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241158|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241159|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241387|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241160|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241161|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241162|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241163|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241164|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241165|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241166|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241167|NCT00117676|E3|Reported Event|Open-Label TDF|"Adverse events for this reporting group include those occurring during the open-label TDF 300 mg period (Week 49 up to Week 384), regardless of which group they were randomized to in the double-blind period.~TDF 300 mg+ADV placebo or ADV 10 mg+TDF placebo (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their treatment regimen in the open-label period."
1241168|NCT00117676|E2|Reported Event|Double-Blind ADV|"Adverse events this reporting group include those occurring in the ADV-TDF group during the double-blind period only (baseline to Week 48).~ADV 10 mg plus placebo to match TDF (double-blind period)."
1241169|NCT00117676|E1|Reported Event|Double-Blind TDF|"Adverse events this reporting group include those occurring in the TDF-TDF group during the double-blind period only (baseline to Week 48).~TDF 300 mg plus placebo to match ADV (double-blind period)."
1241170|NCT00117637|B3|Baseline|Total|Total of all reporting groups
1241288|NCT00117559|P1|Participant Flow|TEL-CBT|"Telehealth, problem solving based treatment~Telehealth Treatment: Participants receive a 15-minute telephone call for 8 weeks"
1241289|NCT00117559|O2|Outcome|Treatment as Usual|Control group
1241171|NCT00117637|B2|Baseline|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241172|NCT00117637|B1|Baseline|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241173|NCT00117637|P2|Participant Flow|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241174|NCT00117637|P1|Participant Flow|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241175|NCT00117637|O2|Outcome|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241176|NCT00117637|O1|Outcome|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241177|NCT00117637|O2|Outcome|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241178|NCT00117637|O1|Outcome|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241388|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1252081|NCT00087646|B5|Baseline|Total|Total of all reporting groups
1241179|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241180|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241181|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241182|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241183|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241290|NCT00117559|O1|Outcome|TEL-CBT|"Telehealth, problem solving based treatment~Telehealth Treatment: Participants receive a 15-minute telephone call for 8 weeks"
1241291|NCT00117559|E2|Reported Event|Treatment as Ususal|Control group
1241184|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241185|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241186|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241187|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241188|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241189|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241190|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241191|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241192|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241342|NCT00117286|O2|Outcome|Degarelix (80 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
1241193|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241194|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241195|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241196|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241197|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241198|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241199|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241200|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241201|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241202|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241203|NCT00117637|O2|Outcome|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241204|NCT00117637|O1|Outcome|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241205|NCT00117637|O2|Outcome|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241206|NCT00117637|O1|Outcome|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241389|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241207|NCT00117637|O2|Outcome|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241208|NCT00117637|O1|Outcome|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241209|NCT00117637|O2|Outcome|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241210|NCT00117637|O1|Outcome|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241211|NCT00117637|O2|Outcome|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241324|NCT00117312|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
1241212|NCT00117637|O1|Outcome|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241213|NCT00117637|O2|Outcome|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241214|NCT00117637|O1|Outcome|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241215|NCT00117637|O2|Outcome|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241216|NCT00117637|O1|Outcome|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241217|NCT00117637|O2|Outcome|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241218|NCT00117637|O1|Outcome|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241219|NCT00117637|O2|Outcome|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241220|NCT00117637|O1|Outcome|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241343|NCT00117286|O1|Outcome|Degarelix (60 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
1241221|NCT00117637|O2|Outcome|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241222|NCT00117637|O1|Outcome|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241223|NCT00117637|O2|Outcome|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241224|NCT00117637|O1|Outcome|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241225|NCT00117637|O2|Outcome|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241325|NCT00117312|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
1241226|NCT00117637|O1|Outcome|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241227|NCT00117637|O2|Outcome|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241228|NCT00117637|O1|Outcome|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241229|NCT00117637|O2|Outcome|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241230|NCT00117637|O1|Outcome|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241231|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241232|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241233|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241234|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241372|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241373|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241235|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241236|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241237|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241238|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241292|NCT00117559|E1|Reported Event|TEL-CBT|"Telehealth, problem solving based treatment~Telehealth Treatment: Participants receive a 15-minute telephone call for 8 weeks"
1241293|NCT00117338|B3|Baseline|Total|Total of all reporting groups
1241294|NCT00117338|B2|Baseline|Placebo|
1241295|NCT00117338|B1|Baseline|Montelukast Intravenous (IV) 5.25 mg|
1241296|NCT00117338|P2|Participant Flow|Placebo|
1241297|NCT00117338|P1|Participant Flow|Montelukast Intravenous (IV) 5.25 mg|
1241239|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241240|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241241|NCT00117637|E4|Reported Event|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241242|NCT00117637|E3|Reported Event|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241243|NCT00117637|E2|Reported Event|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
1241244|NCT00117637|E1|Reported Event|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
1241245|NCT00117598|B4|Baseline|Total|Total of all reporting groups
1241246|NCT00117598|B3|Baseline|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
1241247|NCT00117598|B2|Baseline|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
1241248|NCT00117598|B1|Baseline|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
1241249|NCT00117598|P5|Participant Flow|Investigator's Choice Then Temsirolimus 175/75 mg|Participants received 1 single-agent treatment chosen by investigator until treatment cross over allowed (via Protocol Amendment 5), then temsirolimus 175 mg IV once weekly for 3 weeks; then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
1241250|NCT00117598|P4|Participant Flow|Temsirolimus 175/25 mg Then 75 mg|Temsirolimus 175 mg administered IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until treatment cross over allowed (via Protocol Amendment 5), then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
1241251|NCT00117598|P3|Participant Flow|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
1241252|NCT00117598|P2|Participant Flow|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
1241253|NCT00117598|P1|Participant Flow|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
1241298|NCT00117338|O2|Outcome|Placebo|
1241299|NCT00117338|O1|Outcome|Montelukast Intravenous (IV) 5.25 mg|
1241300|NCT00117338|O2|Outcome|Placebo|
1241301|NCT00117338|O1|Outcome|Montelukast Intravenous (IV) 5.25 mg|
1241302|NCT00117338|O2|Outcome|Placebo|
1241303|NCT00117338|O1|Outcome|Montelukast Intravenous (IV) 5.25 mg|
1241304|NCT00117338|O2|Outcome|Placebo|
1241305|NCT00117338|O1|Outcome|Montelukast Intravenous (IV) 5.25 mg|
1241306|NCT00117338|O2|Outcome|Placebo|
1241307|NCT00117338|O1|Outcome|Montelukast Intravenous (IV) 5.25 mg|
1241254|NCT00117598|O3|Outcome|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
1241255|NCT00117598|O2|Outcome|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
1241256|NCT00117598|O1|Outcome|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
1241257|NCT00117598|O3|Outcome|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
1241258|NCT00117598|O2|Outcome|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
1241259|NCT00117598|O1|Outcome|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
1241260|NCT00117598|O3|Outcome|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
1241261|NCT00117598|O2|Outcome|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
1241262|NCT00117598|O1|Outcome|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
1241263|NCT00117598|O3|Outcome|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
1241264|NCT00117598|O2|Outcome|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
1241265|NCT00117598|O1|Outcome|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
1241281|NCT00117585|P1|Participant Flow|Arm 1|"Stepped intervention consisting of three treatment phases~Treatment 1 :~Patient Education Physical Therapy Exercises Increased Salt Intake Elevation of head of bed with 2-4 inch wedge Medication Review by MD, Pharmacist~Treatment 2 : Fludrocortisone Salt tablets~Treatment 3 : Individualized treatment based on subspecialty or orthostatic hypotension consultation at the medical center"
1241266|NCT00117598|O3|Outcome|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
1241267|NCT00117598|O2|Outcome|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
1241268|NCT00117598|O1|Outcome|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
1241308|NCT00117338|O2|Outcome|Placebo|
1241269|NCT00117598|O3|Outcome|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
1241270|NCT00117598|O2|Outcome|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
1241271|NCT00117598|O1|Outcome|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
1241272|NCT00117598|O3|Outcome|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
1241273|NCT00117598|O2|Outcome|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
1241274|NCT00117598|O1|Outcome|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
1241275|NCT00117598|E5|Reported Event|Investigator's Choice Then Temsirolimus 175/75 mg|Participants received 1 single-agent treatment chosen by investigator until treatment cross over allowed (via Protocol Amendment 5), then temsirolimus 175 mg IV once weekly for 3 weeks; then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal. AEs presented for these participants after they crossed over to 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
1241276|NCT00117598|E4|Reported Event|Temsirolimus 175/25 mg Then 75 mg|Temsirolimus 175 mg administered IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until treatment cross over allowed (via Protocol Amendment 5), then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal. Adverse events (AEs) presented for these participants after they crossed over to 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
1241277|NCT00117598|E3|Reported Event|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
1241278|NCT00117598|E2|Reported Event|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
1241279|NCT00117598|E1|Reported Event|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal. Includes participants who received Temsirolimus 175/75 mg prior to crossover (Protocol Amendment 5).
1241280|NCT00117585|B1|Baseline|Arm 1|"Stepped intervention consisting of three treatment phases~Treatment 1 :~Patient Education Physical Therapy Exercises Increased Salt Intake Elevation of head of bed with 2-4 inch wedge Medication Review by MD, Pharmacist~Treatment 2 : Fludrocortisone Salt tablets~Treatment 3 : Individualized treatment based on subspecialty or orthostatic hypotension consultation at the medical center"
1241341|NCT00117286|O1|Outcome|Degarelix (60 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
1241374|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241282|NCT00117585|O1|Outcome|Arm 1|"Stepped intervention consisting of three treatment phases~Treatment 1 :~Patient Education Physical Therapy Exercises Increased Salt Intake Elevation of head of bed with 2-4 inch wedge Medication Review by MD, Pharmacist~Treatment 2 : Fludrocortisone Salt tablets~Treatment 3 : Individualized treatment based on subspecialty or orthostatic hypotension consultation at the medical center"
1241283|NCT00117585|E1|Reported Event|Arm 1|"Stepped intervention consisting of three treatment phases~Treatment 1 :~Patient Education Physical Therapy Exercises Increased Salt Intake Elevation of head of bed with 2-4 inch wedge Medication Review by MD, Pharmacist~Treatment 2 : Fludrocortisone Salt tablets~Treatment 3 : Individualized treatment based on subspecialty or orthostatic hypotension consultation at the medical center"
1241284|NCT00117559|B3|Baseline|Total|Total of all reporting groups
1241285|NCT00117559|B2|Baseline|Treatment as Usual|Control group
1241286|NCT00117559|B1|Baseline|TEL-CBT|"Telehealth, problem solving based treatment~Telehealth Treatment: Participants receive a 15-minute telephone call for 8 weeks"
1241287|NCT00117559|P2|Participant Flow|Treatment as Usual|Control group
1241309|NCT00117338|O1|Outcome|Montelukast Intravenous (IV) 5.25 mg|
1241331|NCT00117312|E4|Reported Event|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
1241332|NCT00117312|E3|Reported Event|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
1241333|NCT00117312|E2|Reported Event|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
1241334|NCT00117312|E1|Reported Event|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
1241335|NCT00117286|B3|Baseline|Total|Total of all reporting groups
1241336|NCT00117286|B2|Baseline|Degarelix (80 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
1241337|NCT00117286|B1|Baseline|Degarelix (60 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
1241338|NCT00117286|P2|Participant Flow|Degarelix (80 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
1241339|NCT00117286|P1|Participant Flow|Degarelix (60 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
1241340|NCT00117286|O2|Outcome|Degarelix (80 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
1241375|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241376|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241344|NCT00117286|E2|Reported Event|Degarelix (80 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
1241345|NCT00117286|E1|Reported Event|Degarelix (60 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
1241346|NCT00117156|B1|Baseline|Fludarabine and Rituximab|"Fludarabine:~25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles~Rituximab:~375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L~Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.~Fludarabine~Rituximab"
1241347|NCT00117156|P1|Participant Flow|Fludarabine and Rituximab|"Fludarabine:~25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles~Rituximab:~375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L~Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.~Fludarabine~Rituximab"
1241348|NCT00117156|O1|Outcome|Fludarabine and Rituximab|"Fludarabine:~25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles~Rituximab:~375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L~Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.~Fludarabine~Rituximab"
1241349|NCT00117156|O1|Outcome|Fludarabine and Rituximab|"Fludarabine:~25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles~Rituximab:~375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L~Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.~Fludarabine~Rituximab"
1241350|NCT00117156|O1|Outcome|Fludarabine and Rituximab|"Fludarabine:~25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles~Rituximab:~375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L~Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.~Fludarabine~Rituximab"
1241351|NCT00117156|O1|Outcome|Fludarabine and Rituximab|"Fludarabine:~25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles~Rituximab:~375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L~Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.~Fludarabine~Rituximab"
1241352|NCT00117156|O1|Outcome|Fludarabine and Rituximab|"Fludarabine:~25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles~Rituximab:~375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L~Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.~Fludarabine~Rituximab"
1241353|NCT00117156|E1|Reported Event|Fludarabine and Rituximab|"Fludarabine:~25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles~Rituximab:~375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L~Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.~Fludarabine~Rituximab"
1241354|NCT00116857|B3|Baseline|Total|Total of all reporting groups
1241355|NCT00116857|B2|Baseline|Sertraline/Corn Oil|Sertaline 50mg tablets 1 by mouth everyday, plus corn oil placebo capsules 2g by mouth everyday.
1253270|NCT00083174|O2|Outcome|Placebo|Placebo tablet daily
1241356|NCT00116857|B1|Baseline|Sertraline Plus Omega-3 Supplement|Sertaline 50mg tablets 1 by mouth everyday, plus Omega-3 supplement capsules 2g by mouth everyday.
1241357|NCT00116857|P2|Participant Flow|Sertraline/Corn Oil|Sertraline 50mg 1 tablet by mouth everyday. Plus corn oil placebo capsules 2 g by mouth everyday.
1241358|NCT00116857|P1|Participant Flow|Sertraline Plus Omega-3 Supplement|Sertraline 50mg 1 tablet by mouth everyday. Plus Omega-3 supplement capsules 2g by mouth everyday.
1241359|NCT00116857|O2|Outcome|Sertraline/Corn Oil|Sertaline 50mg tablets 1 by mouth everyday, plus corn oil placebo capsules 2g by mouth everyday.
1241360|NCT00116857|O1|Outcome|Sertraline Plus Omega-3 Supplement|Sertaline 50mg tablets 1 by mouth everyday, plus Omega-3 supplement capsules 2g by mouth everyday.
1241361|NCT00116857|E2|Reported Event|Sertraline/Corn Oil|Sertaline 50mg tablets 1 by mouth everyday, plus corn oil placebo capsules 2g by mouth everyday.
1241362|NCT00116857|E1|Reported Event|Sertraline Plus Omega-3 Supplement|Sertaline 50mg tablets 1 by mouth everyday, plus Omega-3 supplement capsules 2g by mouth everyday.
1241363|NCT00116831|B3|Baseline|Total|Total of all reporting groups
1241364|NCT00116831|B2|Baseline|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241365|NCT00116831|B1|Baseline|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241366|NCT00116831|P2|Participant Flow|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241367|NCT00116831|P1|Participant Flow|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241368|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241369|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241370|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241371|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241390|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241391|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241392|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241393|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241394|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241395|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241396|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241397|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241398|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241399|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241400|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241401|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241402|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241403|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241404|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241405|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241406|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241407|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241408|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241409|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241410|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241411|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241412|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241413|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241414|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241415|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241416|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241417|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241418|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241419|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241420|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241421|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241422|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241423|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241424|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241425|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241426|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241427|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241428|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241429|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241430|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241431|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241432|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241433|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241434|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241435|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241436|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241437|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241438|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241439|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241440|NCT00116831|E2|Reported Event|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
1241441|NCT00116831|E1|Reported Event|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
1241442|NCT00116805|B3|Baseline|Total|Total of all reporting groups
1241443|NCT00116805|B2|Baseline|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241444|NCT00116805|B1|Baseline|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added emtricitabine (FTC) to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241445|NCT00116805|P2|Participant Flow|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241446|NCT00116805|P1|Participant Flow|TDF-TDF|Tenofovir disoproxil fumarate (TDF) 300 mg plus placebo to match adefovir dipivoxil (ADV) (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added emtricitabine (FTC) to their treatment regimen (as part of FTC 200 mg/TDF 300 mg fixed-dose combination (FDC) tablet) in the open-label period.
1241447|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241448|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241449|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241450|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241451|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241452|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241453|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241454|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241455|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241456|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241457|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241458|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241459|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241460|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241461|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241462|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241463|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241464|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241713|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
1241465|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241466|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241467|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241468|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241469|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241470|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241471|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241472|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241587|NCT00116753|O1|Outcome|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
1241473|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241474|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241475|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241476|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241477|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241478|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241479|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241480|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241481|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
1241482|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
1241483|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241484|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241485|NCT00116805|O2|Outcome|ADV-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241486|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241487|NCT00116805|O2|Outcome|ADV-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241488|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241489|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241490|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241491|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241492|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241493|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241494|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241495|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241496|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241497|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241498|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241731|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
1241499|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241500|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241501|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241502|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241503|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241504|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241505|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241506|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241507|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241508|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241509|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241510|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241511|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241512|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241513|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241514|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241515|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241516|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241517|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241518|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241519|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241520|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241521|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241522|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period..
1241523|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241524|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added emtricitabine (FTC) to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241799|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
1241525|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241526|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241527|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241528|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241529|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241530|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241531|NCT00116805|O2|Outcome|ADV 10 mg|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241532|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
1241533|NCT00116805|E3|Reported Event|Open-Label TDF|"Adverse events for this reporting group include those occurring during the open-label TDF 300 mg period (Week 49 up to Week 480), regardless of which group they were randomized to in the double-blind period.~TDF 300 mg + ADV placebo or ADV 10 mg + TDF placebo (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period."
1241534|NCT00116805|E2|Reported Event|Double-Blind ADV|"Adverse events this reporting group include those occurring in the ADV-TDF group during the double-blind period only (baseline to Week 48).~ADV 10 mg plus placebo to match TDF (double-blind period)."
1241535|NCT00116805|E1|Reported Event|Double-Blind TDF|"Adverse events this reporting group include those occurring in the TDF-TDF group during the double-blind period only (baseline to Week 48).~TDF 300 mg plus placebo to match ADV (double-blind period)."
1241536|NCT00116779|B3|Baseline|Total|Total of all reporting groups
1241537|NCT00116779|B2|Baseline|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
1241538|NCT00116779|B1|Baseline|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
1241539|NCT00116779|P2|Participant Flow|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
1241540|NCT00116779|P1|Participant Flow|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
1241541|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
1241542|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
1241572|NCT00116753|B1|Baseline|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
1241543|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
1241544|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
1241545|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
1241546|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
1241547|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
1241548|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
1241549|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
1241550|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
1241551|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
1241588|NCT00116753|O3|Outcome|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
1241552|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
1241553|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
1241554|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
1241555|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
1241556|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
1241557|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
1241558|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
1241559|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
1241560|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
1241561|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
1241562|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
1241563|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
1241564|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
1241565|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
1241566|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
1241567|NCT00116779|E2|Reported Event|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
1241568|NCT00116779|E1|Reported Event|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
1241569|NCT00116753|B4|Baseline|Total|Total of all reporting groups
1241570|NCT00116753|B3|Baseline|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
1241571|NCT00116753|B2|Baseline|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
1253271|NCT00083174|O1|Outcome|Exemestane|25 mg of exemestane tablet daily
1241573|NCT00116753|P3|Participant Flow|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
1241574|NCT00116753|P2|Participant Flow|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
1241575|NCT00116753|P1|Participant Flow|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
1241576|NCT00116753|O3|Outcome|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
1241577|NCT00116753|O2|Outcome|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
1241578|NCT00116753|O1|Outcome|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
1241579|NCT00116753|O3|Outcome|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
1241580|NCT00116753|O2|Outcome|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
1241581|NCT00116753|O1|Outcome|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
1241582|NCT00116753|O3|Outcome|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
1241583|NCT00116753|O2|Outcome|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
1241584|NCT00116753|O1|Outcome|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
1241585|NCT00116753|O3|Outcome|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
1241586|NCT00116753|O2|Outcome|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
1241589|NCT00116753|O2|Outcome|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
1241590|NCT00116753|O1|Outcome|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
1241591|NCT00116753|E3|Reported Event|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
1241592|NCT00116753|E2|Reported Event|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
1241593|NCT00116753|E1|Reported Event|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
1241594|NCT00116688|B3|Baseline|Total|Total of all reporting groups
1241595|NCT00116688|B2|Baseline|Romiplostim in Pediatric Population|Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
1241596|NCT00116688|B1|Baseline|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
1241597|NCT00116688|P2|Participant Flow|Romiplostim in Pediatric Population|Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
1241598|NCT00116688|P1|Participant Flow|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
1241599|NCT00116688|O1|Outcome|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
1241600|NCT00116688|O1|Outcome|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
1241601|NCT00116688|O1|Outcome|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
1241602|NCT00116688|O1|Outcome|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
1241642|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
1241603|NCT00116688|O1|Outcome|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
1241604|NCT00116688|O2|Outcome|Romiplostim in Pediatric Population|Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
1241605|NCT00116688|O1|Outcome|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
1241606|NCT00116688|O2|Outcome|Romiplostim in Pediatric Population|Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
1241607|NCT00116688|O1|Outcome|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
1241608|NCT00116688|O2|Outcome|Romiplostim in Pediatric Population|Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
1241653|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
1241655|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
1241609|NCT00116688|O1|Outcome|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
1241610|NCT00116688|E2|Reported Event|Romiplostim in Pediatric Population|Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
1241611|NCT00116688|E1|Reported Event|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
1241612|NCT00116649|B1|Baseline|Aldara (Imiquimod) Cream|Aldara (imiquimod) Cream 5%
1241613|NCT00116649|P1|Participant Flow|Aldara (Imiquimod) Cream|Aldara (imiquimod) Cream 5%
1241614|NCT00116649|O1|Outcome|Aldara (Imiquimod) Cream|Aldara (imiquimod) Cream 5%
1241615|NCT00116649|O1|Outcome|Aldara (Imiquimod) Cream|Aldara (imiquimod) Cream 5%
1241616|NCT00116649|E1|Reported Event|Aldara (Imiquimod) Cream|Aldara (imiquimod) Cream 5%
1241617|NCT00116428|B3|Baseline|Total|Total of all reporting groups
1241618|NCT00116428|B2|Baseline|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
1241619|NCT00116428|B1|Baseline|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
1241620|NCT00116428|P2|Participant Flow|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
1241621|NCT00116428|P1|Participant Flow|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
1241622|NCT00116428|O3|Outcome|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame.
1241623|NCT00116428|O2|Outcome|Antiarrhythmic Drug Subjects Undergoing Ablation|Control subjects underwent a study ablation procedure after failing the effectiveness endpoint.
1241706|NCT00116168|B3|Baseline|MEDI-528 3 mg|
1241707|NCT00116168|B2|Baseline|MEDI-528 1 mg|
1241624|NCT00116428|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
1241625|NCT00116428|O3|Outcome|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame.
1241626|NCT00116428|O2|Outcome|Antiarrhythmic Drug Subjects Undergoing Ablation|Control Group Subjects underwent a study ablation procedure after failing the effectiveness endpoint.
1241627|NCT00116428|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
1241628|NCT00116428|O2|Outcome|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
1241629|NCT00116428|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
1241654|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
1241630|NCT00116428|O2|Outcome|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
1241631|NCT00116428|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
1241632|NCT00116428|O2|Outcome|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
1241633|NCT00116428|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
1241634|NCT00116428|E2|Reported Event|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame AND didn't undergo a study ablation procedure.
1241635|NCT00116428|E1|Reported Event|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization; OR received the Catheter after failing the effectiveness endpoint. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
1241636|NCT00116272|B3|Baseline|Total|Total of all reporting groups
1241637|NCT00116272|B2|Baseline|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
1241638|NCT00116272|B1|Baseline|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
1241639|NCT00116272|P2|Participant Flow|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
1241640|NCT00116272|P1|Participant Flow|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
1241641|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
1241708|NCT00116168|B1|Baseline|MEDI-528 0.3 mg|
1241709|NCT00116168|P4|Participant Flow|MEDI-528 9 mg|
1241643|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
1241644|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
1241645|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
1241646|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
1241647|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
1241648|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
1241649|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
1241650|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
1241651|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
1241652|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
1241656|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
1241657|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
1241658|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
1241659|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
1241660|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
1241661|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
1241662|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
1241663|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
1241664|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
1241665|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
1241666|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
1241667|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
1241668|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
1241669|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
1241670|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
1241671|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
1241672|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
1241710|NCT00116168|P3|Participant Flow|MEDI-528 3 mg|
1241673|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
1241674|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
1241675|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
1241676|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
1241677|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
1241678|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
1241679|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
1241680|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
1241681|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
1241682|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
1253149|NCT00083889|B3|Baseline|Total|Total of all reporting groups
1241683|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
1241684|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
1241685|NCT00116272|E4|Reported Event|Infants Etanercept Exposed|Infants born to pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
1241686|NCT00116272|E3|Reported Event|Infants Diseased Control|Infants born to pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
1241687|NCT00116272|E2|Reported Event|Mothers Etanercept Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
1241688|NCT00116272|E1|Reported Event|Mothers Diseased Control|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
1241689|NCT00116207|B3|Baseline|Total|Total of all reporting groups
1241690|NCT00116207|B2|Baseline|Placebo|"Placebo administered twice daily.~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
1241691|NCT00116207|B1|Baseline|ORAL ANTIOXIDANT|"Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
1241692|NCT00116207|P2|Participant Flow|Placebo|"Placebo administered twice daily.~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
1241693|NCT00116207|P1|Participant Flow|ORAL ANTIOXIDANT|"Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
1241694|NCT00116207|O2|Outcome|Placebo|"Placebo administered twice daily.~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
1241695|NCT00116207|O1|Outcome|ORAL ANTIOXIDANT|"Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
1241696|NCT00116207|O2|Outcome|Placebo|"Placebo administered twice daily.~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
1241697|NCT00116207|O1|Outcome|ORAL ANTIOXIDANT|"Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
1241698|NCT00116207|O2|Outcome|Placebo|"Placebo administered twice daily.~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
1241699|NCT00116207|O1|Outcome|ORAL ANTIOXIDANT|"Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
1241700|NCT00116207|O2|Outcome|Placebo|"Placebo administered twice daily.~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
1241701|NCT00116207|O1|Outcome|ORAL ANTIOXIDANT|"Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
1241702|NCT00116207|E2|Reported Event|Placebo|"Placebo administered twice daily.~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
1241703|NCT00116207|E1|Reported Event|ORAL ANTIOXIDANT|"Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
1241704|NCT00116168|B5|Baseline|Total|Total of all reporting groups
1241705|NCT00116168|B4|Baseline|MEDI-528 9 mg|
1241714|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
1241715|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
1241716|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
1241717|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
1241718|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
1241719|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
1241720|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
1241721|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
1241722|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
1241723|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
1241724|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
1241725|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
1241726|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
1241727|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
1241728|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
1241729|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
1241730|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
1241732|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
1241733|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
1241734|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
1241735|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
1241736|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
1241737|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
1241738|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
1241739|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
1241740|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
1241741|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
1241742|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
1241743|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
1241744|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
1241745|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
1241746|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
1241747|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
1241748|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
1241749|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
1241750|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
1241751|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
1241752|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
1241753|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
1241754|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
1241755|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
1241756|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
1241757|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
1241758|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
1241759|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
1241760|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
1241761|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
1241762|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
1241763|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
1241764|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
1241765|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
1241766|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
1241767|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
1241768|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
1241769|NCT00116168|E4|Reported Event|MEDI-528 9 mg|
1241770|NCT00116168|E3|Reported Event|MEDI-528 3 mg|
1241771|NCT00116168|E2|Reported Event|MEDI-528 1 mg|
1241772|NCT00116168|E1|Reported Event|MEDI-528 0.3 mg|
1241773|NCT00115934|B3|Baseline|Total|Total of all reporting groups
1241774|NCT00115934|B2|Baseline|RVPAS|Right ventricular to pulmonary artery shunt
1241775|NCT00115934|B1|Baseline|MBTS|Blalock-Taussig pulmonary artery shunt
1241776|NCT00115934|P2|Participant Flow|RVPAS|Right ventricular to pulmonary artery shunt
1241777|NCT00115934|P1|Participant Flow|MBTS|Blalock-Taussig pulmonary artery shunt
1241778|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
1241779|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
1241780|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
1241781|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
1241782|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
1241783|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
1241784|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
1241785|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
1241786|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
1241787|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
1241788|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
1241789|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
1241790|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
1241791|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
1241792|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
1241793|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
1241794|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
1241795|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
1241796|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
1241797|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
1241798|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
1241800|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
1241801|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
1241802|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
1241803|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
1241804|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
1241805|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
1241806|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
1241807|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
1241808|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
1241809|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
1241810|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
1241811|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
1241812|NCT00115934|E2|Reported Event|RVPAS|Right ventricular to pulmonary artery shunt
1241813|NCT00115934|E1|Reported Event|MBTS|Blalock-Taussig pulmonary artery shunt
1241814|NCT00115869|B3|Baseline|Total|Total of all reporting groups
1241815|NCT00115869|B2|Baseline|Social Influences School-based Smoking Prevention Curriculum|Social influences school-based smoking prevention curriculum group
1241816|NCT00115869|B1|Baseline|No-intervention Control|No-intervention control group
1241817|NCT00115869|P2|Participant Flow|Grade 3-12 School-based Intervention|Grade 3-12 school-influences school-based smoking prevention intervention
1241818|NCT00115869|P1|Participant Flow|No-intervention Control|No-intervention control group
1241819|NCT00115869|O2|Outcome|School-based Smoking Prevention Curriculum|Social influences school-based smoking prevention curriculum group
1241820|NCT00115869|O1|Outcome|No-intervention Control|No-intervention control group
1241821|NCT00115869|O2|Outcome|Social Influences School-based Smoking Prevention Curriculum|School-based social-influences smoking prevention curriculum condition
1241822|NCT00115869|O1|Outcome|No-intervention Control|No-intervention control condition
1241823|NCT00115869|E2|Reported Event|School-based Smoking Prevention Curriculum Group|school-based smoking prevention curriculum
1241824|NCT00115869|E1|Reported Event|No-intervention Control Group|no-intervention control
1241825|NCT00115804|B1|Baseline|Fluoxetine|All eligible patients were given fluoxetine
1241826|NCT00115804|P1|Participant Flow|Fluoxetine|All patients receiving Fluoxetine starting at 10 mg/day
1241827|NCT00115804|O1|Outcome|Fluoxetine|All patients receiving Fluoxetine starting at 10 mg/day
1241828|NCT00115804|O1|Outcome|Fluoxetine|All patients receiving Fluoxetine starting at 10 mg/day
1241829|NCT00115804|O1|Outcome|Fluoxetine|All patients receiving Fluoxetine starting at 10 mg/day
1241830|NCT00115804|O1|Outcome|Fluoxetine|All patients receiving Fluoxetine starting at 10 mg/day
1241831|NCT00115804|O1|Outcome|Fluoxetine|All patients receiving Fluoxetine starting at 10 mg/day
1241832|NCT00115804|O1|Outcome|Fluoxetine|All patients receiving Fluoxetine starting at 10 mg/day
1241833|NCT00115804|O1|Outcome|Fluoxetine|"All eligible patients were started on Fluoxetine at 10 mg once daily. The dose was flexibly dosed based on pain efficacy and tolerability to a final dose between 10 and 60 mg once daily.~Fluoxetine: fluoxetine po 10-60 mg/day for 12 weeks~Fluoxetine: Fluoxetine was started at 10 mg once daily. The dose was flexibly dosed based on pain efficacy and tolerability to a final dose between 10 and 60 mg once daily."
1241834|NCT00115804|O1|Outcome|Fluoxetine|Fluoxetine was started at 10 mg/day and adjusted based on pain efficacy and tolerability.
1241835|NCT00115804|E1|Reported Event|Fluoxetine|Fluoxetine was started at 10 mg/day and adjusted based on pain efficacy and tolerability.
1241836|NCT00115765|B5|Baseline|Total|Total of all reporting groups
1241837|NCT00115765|B4|Baseline|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
1241838|NCT00115765|B3|Baseline|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
1241839|NCT00115765|B2|Baseline|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
1241840|NCT00115765|B1|Baseline|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
1241841|NCT00115765|P4|Participant Flow|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
1241842|NCT00115765|P3|Participant Flow|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
1241843|NCT00115765|P2|Participant Flow|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
1241844|NCT00115765|P1|Participant Flow|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
1241845|NCT00115765|O2|Outcome|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
1241846|NCT00115765|O1|Outcome|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
1241847|NCT00115765|O2|Outcome|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
1241848|NCT00115765|O1|Outcome|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
1241849|NCT00115765|O2|Outcome|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
1241850|NCT00115765|O1|Outcome|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
1241851|NCT00115765|O2|Outcome|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
1241852|NCT00115765|O1|Outcome|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
1241853|NCT00115765|O2|Outcome|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
1241854|NCT00115765|O1|Outcome|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
1255487|NCT00071812|B5|Baseline|Total|Total of all reporting groups
1241855|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
1241856|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
1241857|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
1241858|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
1241859|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
1241860|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
1241861|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
1241862|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
1241863|NCT00115765|O2|Outcome|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
1241864|NCT00115765|O1|Outcome|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
1241865|NCT00115765|O2|Outcome|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
1241866|NCT00115765|O1|Outcome|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
1241867|NCT00115765|O2|Outcome|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
1241868|NCT00115765|O1|Outcome|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
1241869|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
1241870|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
1241871|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
1241872|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
1241873|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
1241874|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
1241875|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
1241876|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
1241877|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
1241878|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
1241879|NCT00115765|E2|Reported Event|Bevacizumab With Chemotherapy|
1241880|NCT00115765|E1|Reported Event|Panit. Plus Bevacizumab With Chemotherapy|
1241881|NCT00115739|B1|Baseline|Imatinib (Gleevec) Tablets|patients with Anaplastic thyroid cancer were administered Gleevec tablets From February 2004 to May 2007
1241882|NCT00115739|P1|Participant Flow|Imatinib (Gleevec) Tablets|4 (100 mg tablets) = 400 mg dose twice per day (morning and evening) for 16 weeks
1241883|NCT00115739|O1|Outcome|Imatinib (Gleevec) Tablets|patients with Anaplastic thyroid cancer were administered Gleevec tablets From February 2004 to May 2007
1241884|NCT00115739|O1|Outcome|Imatinib (Gleevec) Tablets|patients with Anaplastic thyroid cancer were administered Gleevec tablets From February 2004 to May 2007
1241885|NCT00115739|O1|Outcome|Imatinib (Gleevec) Tablets|
1241886|NCT00115739|O1|Outcome|Imatinib (Gleevec) Tablets|Subjects were administered oral Gleevec tablets, then tumor response was assessed
1241887|NCT00115739|E1|Reported Event|Imatinib (Gleevec) Tablets|patients with Anaplastic thyroid cancer were administered Gleevec tablets From February 2004 to May 2007
1241888|NCT00115349|B3|Baseline|Total|Total of all reporting groups
1241919|NCT00115063|O2|Outcome|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
1241889|NCT00115349|B2|Baseline|Deferoxamine (DFO) + Monotherapy|"DFO + Placebo DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.~Placebo Administered orally three times daily."
1241890|NCT00115349|B1|Baseline|Deferoxamine (DFO) and Deferiprone (L1) Combination Therapy|"DFO + L1 DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.~L1 Administered daily at 75 mg/kg in 3 divided doses taken orally and timed so that 2 of 3 doses will be simultaneous with DFO infusion."
1241891|NCT00115349|P2|Participant Flow|Deferoxamine (DFO) + Monotherapy|"DFO + Placebo DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.~Placebo Administered orally three times daily."
1241892|NCT00115349|P1|Participant Flow|Deferoxamine (DFO) and Deferiprone (L1) Combination Therapy|"DFO + L1 DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.~L1 Administered daily at 75 mg/kg in 3 divided doses taken orally and timed so that 2 of 3 doses will be simultaneous with DFO infusion."
1241893|NCT00115349|O2|Outcome|Deferoxamine (DFO) + Monotherapy|"DFO + Placebo DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.~Placebo Administered orally three times daily."
1241894|NCT00115349|O1|Outcome|Deferoxamine (DFO) and Deferiprone (L1) Combination Therapy|"DFO + L1 DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.~L1 Administered daily at 75 mg/kg in 3 divided doses taken orally and timed so that 2 of 3 doses will be simultaneous with DFO infusion."
1241895|NCT00115349|E2|Reported Event|Deferoxamine (DFO) + Monotherapy|"DFO + Placebo DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.~Placebo Administered orally three times daily."
1241932|NCT00114972|P2|Participant Flow|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
1241933|NCT00114972|P1|Participant Flow|CABG|Coronary Artery By-pass Graft (CABG)
1241896|NCT00115349|E1|Reported Event|Deferoxamine (DFO) and Deferiprone (L1) Combination Therapy|"DFO + L1 DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.~L1 Administered daily at 75 mg/kg in 3 divided doses taken orally and timed so that 2 of 3 doses will be simultaneous with DFO infusion."
1241897|NCT00115297|B3|Baseline|Total|Total of all reporting groups
1241898|NCT00115297|B2|Baseline|Placebo|"Placebo (placebo tablets or granules)~Placebo: Participants who are 2 to 3 years old will receive placebo montelukast tablets and participants who are 12 months to 2 years old received placebo montelukast granules."
1241899|NCT00115297|B1|Baseline|Montelukast|"5-mg montelukast tablets or 4 mg granules~Montelukast: Participants who are 2 to 3 years old will receive 5-mg montelukast tablets and participants who are 12 months to 2 years old received 4-mg montelukast granules."
1241900|NCT00115297|P2|Participant Flow|Placebo|"Placebo (montelukast tablet or montelukast granules)~Placebo: Participants who are 2 to 3 years old will receive placebo montelukast tablets and participants who are 12 months to 2 years old will receive placebo montelukast granules."
1241901|NCT00115297|P1|Participant Flow|Monteluksat|"5-mg montelukast tablets or 4 mg granules)~Montelukast: Participants who are 2 to 3 years old will receive 5-mg montelukast tablets and participants who are 12 months to 2 years old will receive 4-mg montelukast granules."
1241902|NCT00115297|O2|Outcome|Placebo|"Placebo (tablets or granules)~Placebo: Participants who were 2 to 3 years old received placebo montelukast tablets and participants who were 12 months to 2 years old received placebo montelukast granules."
1241903|NCT00115297|O1|Outcome|Montelukast|"5-mg montelukast tablets or granules~Montelukast: Participants who are 2 to 3 years old received 5-mg montelukast tablets and participants who were 12 months to 2 years old received 4-mg montelukast granules."
1241904|NCT00115297|O2|Outcome|Placebo|"Placebo (montelukast tablets)~Placebo: Participants who were 2 to 3 years old received placebo montelukast tablets and participants who were 12 months to 2 years old received placebo montelukast granules."
1241905|NCT00115297|O1|Outcome|Montelukast|"5-mg montelukast tablets~Montelukast: Participants who are 2 to 3 years old received 5-mg montelukast tablets and participants who were 12 months to 2 years old received 4-mg montelukast granules."
1241906|NCT00115297|O2|Outcome|Placebo|"Placebo (montelukast tablets)~Placebo: Participants who are 2 to 3 years old received placebo montelukast tablets and participants who were 12 months to 2 years old received placebo montelukast granules."
1241907|NCT00115297|O1|Outcome|Montelukast|"5-mg montelukast tablets~Montelukast: Participants who are 2 to 3 years old received 5-mg montelukast tablets and participants who were 12 months to 2 years old received 4-mg montelukast granules."
1241908|NCT00115297|E2|Reported Event|Placebo|"Placebo (tablets or granules)~Placebo: Participants who are 2 to 3 years old will receive placebo montelukast tablets and participants who are 12 months to 2 years old will receive placebo montelukast granules."
1241909|NCT00115297|E1|Reported Event|Montelukast|"Montelukast tablets or granules~Montelukast: Participants who are 2 to 3 years old received 5-mg montelukast tablets and participants who were 12 months to 2 years old received 4-mg montelukast granules."
1241910|NCT00115063|B3|Baseline|Total|Total of all reporting groups
1241911|NCT00115063|B2|Baseline|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
1241912|NCT00115063|B1|Baseline|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
1241913|NCT00115063|P2|Participant Flow|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
1241914|NCT00115063|P1|Participant Flow|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
1241915|NCT00115063|O2|Outcome|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
1241916|NCT00115063|O1|Outcome|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
1241917|NCT00115063|O2|Outcome|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
1241918|NCT00115063|O1|Outcome|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
1241920|NCT00115063|O1|Outcome|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
1241921|NCT00115063|O2|Outcome|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
1241922|NCT00115063|O1|Outcome|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
1241923|NCT00115063|O2|Outcome|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
1241924|NCT00115063|O1|Outcome|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
1241925|NCT00115063|O2|Outcome|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
1241926|NCT00115063|O1|Outcome|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
1241927|NCT00115063|E2|Reported Event|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
1241928|NCT00115063|E1|Reported Event|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
1241929|NCT00114972|B3|Baseline|Total|Total of all reporting groups
1241930|NCT00114972|B2|Baseline|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
1241931|NCT00114972|B1|Baseline|CABG|Coronary Artery By-pass Graft (CABG)
1256659|NCT00065429|B4|Baseline|IMGN 40 mg/m2|Arm 4, Phase 1
1241934|NCT00114972|O2|Outcome|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
1241935|NCT00114972|O1|Outcome|CABG|Coronary Artery By-pass Graft (CABG)
1241936|NCT00114972|O2|Outcome|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
1241937|NCT00114972|O1|Outcome|CABG|Coronary Artery By-pass Graft (CABG)
1241938|NCT00114972|O2|Outcome|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
1241939|NCT00114972|O1|Outcome|CABG|Coronary Artery By-pass Graft (CABG)
1241940|NCT00114972|O2|Outcome|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
1241941|NCT00114972|O1|Outcome|CABG|Coronary Artery By-pass Graft (CABG)
1241942|NCT00114972|O2|Outcome|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
1241943|NCT00114972|O1|Outcome|CABG|Coronary Artery By-pass Graft (CABG)
1241944|NCT00114972|O2|Outcome|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
1241945|NCT00114972|O1|Outcome|CABG|Coronary Artery By-pass Graft (CABG)
1241946|NCT00114972|O2|Outcome|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
1241947|NCT00114972|O1|Outcome|CABG|Coronary Artery By-pass Graft (CABG)
1241948|NCT00114972|O2|Outcome|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
1241949|NCT00114972|O1|Outcome|CABG|Coronary Artery By-pass Graft (CABG)
1241950|NCT00114972|E2|Reported Event|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
1241951|NCT00114972|E1|Reported Event|CABG|Coronary Artery By-pass Graft (CABG)
1241952|NCT00114959|B1|Baseline|Homoharringtonine + Imatinib Mesylate|Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
1241953|NCT00114959|P1|Participant Flow|Homoharringtonine + Imatinib Mesylate|Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
1241954|NCT00114959|O1|Outcome|Homoharringtonine + Imatinib Mesylate|Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
1241955|NCT00114959|O1|Outcome|Homoharringtonine + Imatinib Mesylate|Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
1241956|NCT00114959|O1|Outcome|Homoharringtonine + Imatinib Mesylate|Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
1241957|NCT00114959|O1|Outcome|Homoharringtonine + Imatinib Mesylate|Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
1241958|NCT00114959|E1|Reported Event|Homoharringtonine + Imatinib Mesylate|Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
1241959|NCT00114634|B1|Baseline|Egg Yolk or no Egg Yolk|All subjects were on cholesterol suspension or egg yolk versus no egg yolk.
1241960|NCT00114634|P1|Participant Flow|Egg Yolk or no Egg Yolk|This was a double-blind, placebo-controlled, cross-over design. The trial was composed of five 2-week phases. Two phases, phases 2 and 4, were double-blinded. During these phases, subjects were either on placebo (egg substitute with no cholesterol) or cholesterol supplementation (pasteurized egg yolk). During the interval phases, 1, 3 and 5, subjects were maintained on baseline therapy of 150 mg/kg/day of crystalline cholesterol suspended in Ora-Plus. Order of placebo versus cholesterol was random with 6 subjects receiving placebo first (in phase 2) and 4 subjects receiving cholesterol containing pasteurized egg yolk first. 13 subjects were enrolled, only 10 subjects completed the study.
1241961|NCT00114634|O2|Outcome|Cholesterol|pasteurized egg yolk
1241962|NCT00114634|O1|Outcome|Placebo|egg substitute
1241963|NCT00114634|O2|Outcome|Cholesterol|pasteurized egg yolk
1241964|NCT00114634|O1|Outcome|Placebo|egg substitute
1241965|NCT00114634|O2|Outcome|Cholesterol|pasteurized egg yolk
1241966|NCT00114634|O1|Outcome|Placebo|egg substitute
1241967|NCT00114634|O2|Outcome|Cholesterol|pasteurized egg yolk
1241968|NCT00114634|O1|Outcome|Placebo|egg substitute
1241969|NCT00114634|O2|Outcome|Cholesterol|pasteurized egg yolk
1241970|NCT00114634|O1|Outcome|Placebo|egg substitute
1242011|NCT00114244|O1|Outcome|Arm I (Sorafenib Tosylate)|"Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.~sorafenib tosylate: Given PO~laboratory biomarker analysis: Correlative studies"
1242012|NCT00114244|O2|Outcome|Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)|"Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15.~sorafenib tosylate: Given PO~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies"
1241971|NCT00114634|O1|Outcome|Crossover Study|This was a double-blind, placebo-controlled, cross-over design. The trial was composed of five 2-week phases. Two phases, phases 2 and 4, were double-blinded. During these phases, subjects were either on placebo (egg substitute with no cholesterol) or cholesterol supplementation (pasteurized egg yolk). During the interval phases, 1, 3 and 5, subjects were maintained on baseline therapy of 150 mg/kg/day of crystalline cholesterol suspended in Ora-Plus. Order of placebo versus cholesterol was random with 6 subjects receiving placebo first (in phase 2) and 4 subjects receiving cholesterol containing pasteurized egg yolk first. 13 subjects were enrolled, only 10 subjects completed the study.
1241972|NCT00114634|E1|Reported Event|Group 1|All subjects were on cholesterol suspension or egg yolk versus no egg yolk.
1241973|NCT00114517|B5|Baseline|Total|Total of all reporting groups
1241974|NCT00114517|B4|Baseline|Late Postmenopause Placebo|
1241975|NCT00114517|B3|Baseline|Late Postmenopause 17B-estradiol|
1241976|NCT00114517|B2|Baseline|Early Postmenopause Placebo|
1241977|NCT00114517|B1|Baseline|Early Postmenopause 17B-estradiol|
1241978|NCT00114517|P4|Participant Flow|Late Postmenopause Placebo|Late postmenopause >10 years-since-menopause
1241979|NCT00114517|P3|Participant Flow|Late Postmenopause 17B-estradiol|Late postmenopause >10 years-since-menopause oral 17B-estradiol 1 mg daily
1241980|NCT00114517|P2|Participant Flow|Early Postmenopause Placebo|Early postmenopause <6 years-since-menopause
1241981|NCT00114517|P1|Participant Flow|Early Postmenopause 17B-estradiol|Early postmenopause, <6 years-since-menopause oral 17B-estradiol 1 mg daily
1241982|NCT00114517|O2|Outcome|Placebo|"Matched placebo oral 17B-estradiol daily~Placebo: Matched placebo oral 17B-estradiol"
1241983|NCT00114517|O1|Outcome|17B-estradiol|"Oral 17B-estradiol 1 mg daily~Oral 17B-estradiol: Oral 17B-estradiol 1 mg daily"
1241984|NCT00114517|O2|Outcome|Placebo|"Matched placebo oral 17B-estradiol daily~Placebo: Matched placebo oral 17B-estradiol"
1241985|NCT00114517|O1|Outcome|17B-estradiol|"Oral 17B-estradiol 1 mg daily~Oral 17B-estradiol: Oral 17B-estradiol 1 mg daily"
1241986|NCT00114517|O2|Outcome|Placebo|"Matched placebo oral 17B-estradiol daily~Placebo: Matched placebo oral 17B-estradiol"
1241987|NCT00114517|O1|Outcome|17B-estradiol|"Oral 17B-estradiol 1 mg daily~Oral 17B-estradiol: Oral 17B-estradiol 1 mg daily"
1241988|NCT00114517|E2|Reported Event|Placebo|"Matched placebo oral 17B-estradiol daily~Placebo: Matched placebo oral 17B-estradiol"
1241989|NCT00114517|E1|Reported Event|17B-estradiol|"Oral 17B-estradiol 1 mg daily~Oral 17B-estradiol: Oral 17B-estradiol 1 mg daily"
1241990|NCT00114504|B3|Baseline|Total|Total of all reporting groups
1241991|NCT00114504|B2|Baseline|Control Group|Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone
1241992|NCT00114504|B1|Baseline|Simvastatin Group|Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy
1241993|NCT00114504|P2|Participant Flow|Control Group|Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone
1241994|NCT00114504|P1|Participant Flow|Simvastatin Group|Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy
1241995|NCT00114504|O4|Outcome|Control Group at 3 Months|Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone for 3 months.
1241996|NCT00114504|O3|Outcome|Control Group Baseline|Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone at baseline
1241997|NCT00114504|O2|Outcome|Simvastatin Group at 3 Month|Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy for 3 months
1241998|NCT00114504|O1|Outcome|Simvastatin Group Baseline|Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy at baseline
1241999|NCT00114504|O2|Outcome|Control Group|Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone or 3 months
1242000|NCT00114504|O1|Outcome|Simvastatin Group|Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy for 3 months
1242001|NCT00114504|E2|Reported Event|Control Group|Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone
1242002|NCT00114504|E1|Reported Event|Simvastatin Group|Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy
1242003|NCT00114244|B3|Baseline|Total|Total of all reporting groups
1242251|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
1242252|NCT00113516|E2|Reported Event|Sunitinib 50 mg (Part 2)|
1242004|NCT00114244|B2|Baseline|Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)|"Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15.~sorafenib tosylate: Given PO~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies"
1242005|NCT00114244|B1|Baseline|Arm I (Sorafenib Tosylate)|"Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.~sorafenib tosylate: Given PO~laboratory biomarker analysis: Correlative studies"
1242006|NCT00114244|P2|Participant Flow|Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)|"Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15.~sorafenib tosylate: Given PO~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies"
1242007|NCT00114244|P1|Participant Flow|Arm I (Sorafenib Tosylate)|"Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.~sorafenib tosylate: Given PO~laboratory biomarker analysis: Correlative studies"
1242008|NCT00114244|O2|Outcome|Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)|"Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15.~sorafenib tosylate: Given PO~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies"
1242009|NCT00114244|O1|Outcome|Arm I (Sorafenib Tosylate)|"Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.~sorafenib tosylate: Given PO~laboratory biomarker analysis: Correlative studies"
1242010|NCT00114244|O2|Outcome|Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)|"Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15.~sorafenib tosylate: Given PO~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies"
1242044|NCT00114101|O2|Outcome|Placebo Maintenance|"Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.~(closed as of 12/17/09)"
1242013|NCT00114244|O1|Outcome|Arm I (Sorafenib Tosylate)|"Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.~sorafenib tosylate: Given PO~laboratory biomarker analysis: Correlative studies"
1242014|NCT00114244|E2|Reported Event|Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)|"Patients receive 400 mg oral sorafenib as in Arm I and gemcitabine IV over 100 minutes on days 1, 8, and 15.~sorafenib tosylate: Given PO~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies"
1242015|NCT00114244|E1|Reported Event|Arm I (Sorafenib Tosylate)|"Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.~sorafenib tosylate: Given PO~laboratory biomarker analysis: Correlative studies"
1242016|NCT00114166|B1|Baseline|Topotecan|Includes both Regimen I Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy and Regimen II Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
1242017|NCT00114166|P1|Participant Flow|Topotecan|Includes both Regimen I Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy and Regimen II Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
1242018|NCT00114166|O1|Outcome|Topotecan|Includes both Regimen I Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy and Regimen II Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
1242019|NCT00114166|O1|Outcome|Topotecan|Includes both Regimen I Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy and Regimen II Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
1242020|NCT00114166|E2|Reported Event|Regimen II|Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
1242021|NCT00114166|E1|Reported Event|Regimen I|Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy
1242022|NCT00114127|B3|Baseline|Total|Total of all reporting groups
1242023|NCT00114127|B2|Baseline|Duloxetine 120mg/Day for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 15 received 120mg duloxetine for 18 additional weeks.
1242024|NCT00114127|B1|Baseline|Duloxetine 60mg/Day + Placebo for 18 Weeks(Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 13 received 60mg duloxetine plus placebo for 18 additional weeks.
1242025|NCT00114127|P2|Participant Flow|Duloxetine 120mg/Day for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 15 received 120mg duloxetine for 18 additional weeks.
1242026|NCT00114127|P1|Participant Flow|Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 13 received 60mg duloxetine plus placebo for 18 additional weeks.
1242027|NCT00114127|O2|Outcome|Duloxetine 120mg/Day for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 15 received 120mg duloxetine for 18 additional weeks.
1242028|NCT00114127|O1|Outcome|Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 13 received 60mg duloxetine plus placebo for 18 additional weeks.
1242029|NCT00114127|O2|Outcome|Duloxetine 120mg/Day for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 15 received 120mg duloxetine for 18 additional weeks.
1242030|NCT00114127|O1|Outcome|Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 13 received 60mg duloxetine plus placebo for 18 additional weeks.
1242031|NCT00114127|E2|Reported Event|Duloxetine 120mg/Day for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 15 received 120mg duloxetine for 18 additional weeks.
1242253|NCT00113516|E1|Reported Event|Carboplatin Plus Paclitaxel 172-225 mg/m2 (Part 1)|
1242254|NCT00113490|B3|Baseline|Total|Total of all reporting groups
1242032|NCT00114127|E1|Reported Event|Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 13 received 60mg duloxetine plus placebo for 18 additional weeks.
1242033|NCT00114101|B3|Baseline|Total|Total of all reporting groups
1242034|NCT00114101|B2|Baseline|Placebo Maintenance|"Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.~(closed as of 12/17/09)"
1242035|NCT00114101|B1|Baseline|Lenalidomide Maintenance|Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
1242036|NCT00114101|P2|Participant Flow|Placebo Maintenance|"Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.~(closed as of 12/17/09)"
1242037|NCT00114101|P1|Participant Flow|Lenalidomide Maintenance|Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
1242038|NCT00114101|O2|Outcome|Placebo Maintenance|"Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.~(closed as of 12/17/09)"
1242039|NCT00114101|O1|Outcome|Lenalidomide Maintenance|Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
1242040|NCT00114101|O2|Outcome|Placebo Maintenance|"Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.~(closed as of 12/17/09)"
1242041|NCT00114101|O1|Outcome|Lenalidomide Maintenance|Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
1242042|NCT00114101|O2|Outcome|Placebo Maintenance|"Beginning between day 100-110, patients receive oral placebo once daily.~(closed as of 12/17/09)"
1242043|NCT00114101|O1|Outcome|Lenalidomide Maintenance|Beginning between day 100-110, patients receive oral lenalidomide once daily.
1242791|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
1242045|NCT00114101|O1|Outcome|Lenalidomide Maintenance|Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
1242046|NCT00114101|E2|Reported Event|Placebo Maintenance|"Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.~(closed as of 12/17/09)"
1242047|NCT00114101|E1|Reported Event|Lenalidomide Maintenance|Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
1242048|NCT00113919|B1|Baseline|Bisulfan|Bisulfan in Multiple Myeloma patients >65 years w/renal insufficiency
1242049|NCT00113919|P1|Participant Flow|Bisulfan|Bisulfan in Multiple Myeloma patients >65 years w/renal insufficiency
1242050|NCT00113919|O1|Outcome|Busulfex|
1242051|NCT00113919|E1|Reported Event|Bisulfan|Bisulfan in Multiple Myeloma patients >65 years w/renal insufficiency
1242052|NCT00113880|B4|Baseline|Total|Total of all reporting groups
1242053|NCT00113880|B3|Baseline|TIV-Vaccinated Control|Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
1242054|NCT00113880|B2|Baseline|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
1242055|NCT00113880|B1|Baseline|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the KP Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose. FluMist recipients served as their own controls based on the observation time after vaccination. In the primary analyses using within-cohort controls, “risk” periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to “reference” observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21.
1242056|NCT00113880|P3|Participant Flow|TIV-Vaccinated Control|Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
1242057|NCT00113880|P2|Participant Flow|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
1242075|NCT00113880|O2|Outcome|Within Cohort Control|FluMist recipients served as their own controls based on the observation time after vaccination. FluMist vaccinated cohort served as its own control. In the primary analyses using within-cohort controls, “risk” periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to “reference” observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21.
1242317|NCT00113334|P1|Participant Flow|ABT-510 (Thrombospondin)|Fixed dose level of thrombospondin 100 mg subcutaneously twice daily.
1242058|NCT00113880|P1|Participant Flow|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the KP Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose. FluMist recipients served as their own controls based on the observation time after vaccination. In the primary analyses using within-cohort controls, “risk” periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to “reference” observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21.
1242059|NCT00113880|O3|Outcome|FluMist Recipients (18-49 Years Old)|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects ≥ 9 years of age were expected to receive only 1 dose.
1242060|NCT00113880|O2|Outcome|FluMist Recipients (9-17 Years Old)|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects ≥ 9 years of age were expected to receive only 1 dose.
1242061|NCT00113880|O1|Outcome|FluMist Recipients (5-8 Years Old)|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist.
1242062|NCT00113880|O3|Outcome|FluMist Recipients (18-49 Years Old)|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects ≥ 9 years of age were expected to receive only 1 dose.
1242063|NCT00113880|O2|Outcome|FluMist Recipients (9-17 Years Old)|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects ≥ 9 years of age were expected to receive only 1 dose.
1242064|NCT00113880|O1|Outcome|FluMist Recipients (5-8 Years Old)|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist.
1242065|NCT00113880|O2|Outcome|TIV-Vaccinated Control|TIV-Vaccinated Control Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
1242792|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
1242066|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
1242067|NCT00113880|O2|Outcome|TIV-Vaccinated Control|TIV-Vaccinated Control Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
1242068|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
1242069|NCT00113880|O2|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
1242070|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
1242071|NCT00113880|O2|Outcome|TIV-Vaccinated Control|TIV-Vaccinated Control Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
1242072|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
1242073|NCT00113880|O2|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
1242074|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
1242242|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
1242243|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
1242076|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
1242077|NCT00113880|O2|Outcome|TIV-Vaccinated Control|TIV-Vaccinated Control Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
1242078|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
1242079|NCT00113880|O2|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
1242080|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
1242081|NCT00113880|O2|Outcome|TIV-Vaccinated Control|TIV-Vaccinated Control Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
1242082|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
1242083|NCT00113880|O2|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
1242084|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
1242085|NCT00113880|O3|Outcome|Unvaccinated Controls|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
1242086|NCT00113880|O2|Outcome|TIV-Vaccinated Control|Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
1242087|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
1242088|NCT00113880|O2|Outcome|TIV-Vaccinated Control|Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
1242089|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
1242090|NCT00113880|O2|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
1242244|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
1242245|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
1242855|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
1242091|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
1242092|NCT00113880|O2|Outcome|TIV-Vaccinated Control|Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
1242093|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
1242094|NCT00113880|O3|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
1242095|NCT00113880|O2|Outcome|Within Cohort Control|FluMist recipients served as their own controls based on the observation time after vaccination. FluMist vaccinated cohort served as its own control. In the primary analyses using within-cohort controls, “risk” periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to “reference” observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21.
1242096|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
1242161|NCT00113607|O2|Outcome|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
1242162|NCT00113607|O1|Outcome|DOXIL|50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
1242097|NCT00113880|O4|Outcome|TIV-Vaccinated Control|Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
1242098|NCT00113880|O3|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
1242099|NCT00113880|O2|Outcome|Within Cohort Control|FluMist recipients served as their own controls based on the observation time after vaccination. FluMist vaccinated cohort served as its own control. In the primary analyses using within-cohort controls, “risk” periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to “reference” observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21.
1242100|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
1242101|NCT00113880|O4|Outcome|TIV-Vaccinated Control|Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
1242102|NCT00113880|O3|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
1242103|NCT00113880|O2|Outcome|Within Cohort Control|FluMist recipients served as their own controls based on the observation time after vaccination. FluMist vaccinated cohort served as its own control. In the primary analyses using within-cohort controls, “risk” periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to “reference” observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21.
1242104|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
1242246|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
1242247|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
1242105|NCT00113880|O4|Outcome|TIV-Vaccinated Control|TIV-Vaccinated Control Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
1242106|NCT00113880|O3|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
1242107|NCT00113880|O2|Outcome|Within Cohort Control|FluMist recipients served as their own controls based on the observation time after vaccination. FluMist vaccinated cohort served as its own control. In the primary analyses using within-cohort controls, “risk” periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to “reference” observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21.
1242108|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
1242109|NCT00113880|O4|Outcome|TIV-Vaccinated Control|TIV-Vaccinated Control Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
1242110|NCT00113880|O3|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
1242793|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
1242111|NCT00113880|O2|Outcome|Within Cohort Control|FluMist recipients served as their own controls based on the observation time after vaccination. FluMist vaccinated cohort served as its own control. In the primary analyses using within-cohort controls, “risk” periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to “reference” observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21.
1242112|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
1242113|NCT00113880|E1|Reported Event|FluMist Recipients|
1242114|NCT00113841|B3|Baseline|Total|Total of all reporting groups
1242115|NCT00113841|B2|Baseline|Curcumin + Bioperine|Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily
1242116|NCT00113841|B1|Baseline|Curcumin|Curcumin starting dose 2 grams orally in two divided doses (a.m., p.m.)
1242117|NCT00113841|P2|Participant Flow|Curcumin + Bioperine|Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily
1242118|NCT00113841|P1|Participant Flow|Curcumin|Curcumin starting dose 2 grams orally in two divided doses (a.m., p.m.)
1242119|NCT00113841|O2|Outcome|Curcumin + Bioperine|Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily
1242120|NCT00113841|O1|Outcome|Curcumin|Curcumin starting dose 2 grams orally in two divided doses (a.m., p.m.)
1242121|NCT00113841|E2|Reported Event|Curcumin + Bioperine|Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily
1242122|NCT00113841|E1|Reported Event|Curcumin|Curcumin starting dose 2 grams orally in two divided doses (a.m., p.m.)
1242123|NCT00113763|B3|Baseline|Total|Total of all reporting groups
1242124|NCT00113763|B2|Baseline|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
1242125|NCT00113763|B1|Baseline|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
1242126|NCT00113763|P2|Participant Flow|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
1242127|NCT00113763|P1|Participant Flow|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
1242248|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
1242128|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
1242129|NCT00113763|O1|Outcome|Panitumumab Plus Best Supportive Care|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
1242130|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
1242131|NCT00113763|O1|Outcome|Panitumumab Plus Best Supportive Care|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
1242132|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
1242133|NCT00113763|O1|Outcome|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
1242134|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
1242135|NCT00113763|O1|Outcome|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
1242163|NCT00113607|O2|Outcome|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
1242164|NCT00113607|O1|Outcome|DOXIL|50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
1242136|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
1242137|NCT00113763|O1|Outcome|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
1242138|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
1242139|NCT00113763|O1|Outcome|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
1242140|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
1242141|NCT00113763|O1|Outcome|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
1242142|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
1242143|NCT00113763|O1|Outcome|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
1242144|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
1242145|NCT00113763|O1|Outcome|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
1242146|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
1242147|NCT00113763|O1|Outcome|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
1242148|NCT00113763|E2|Reported Event|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
1242149|NCT00113763|E1|Reported Event|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
1242150|NCT00113607|B3|Baseline|Total|Total of all reporting groups
1242151|NCT00113607|B2|Baseline|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
1242152|NCT00113607|B1|Baseline|DOXIL|50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
1242153|NCT00113607|P2|Participant Flow|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
1242154|NCT00113607|P1|Participant Flow|DOXIL|50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
1242155|NCT00113607|O1|Outcome|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
1242156|NCT00113607|O1|Outcome|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
1242157|NCT00113607|O2|Outcome|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
1242158|NCT00113607|O1|Outcome|DOXIL|50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
1242159|NCT00113607|O2|Outcome|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
1242160|NCT00113607|O1|Outcome|DOXIL|50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
1242165|NCT00113607|E2|Reported Event|DOXIL|50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
1242166|NCT00113607|E1|Reported Event|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
1242167|NCT00113568|B1|Baseline|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
1242168|NCT00113568|P1|Participant Flow|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
1242169|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
1242170|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
1242171|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
1242172|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
1242173|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
1242174|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
1242175|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
1242176|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
1242177|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
1242178|NCT00113568|E1|Reported Event|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
1242179|NCT00113529|B1|Baseline|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
1242180|NCT00113529|P1|Participant Flow|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 milligrams (mg) or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
1242249|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
1242181|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
1242182|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
1242183|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
1242184|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
1242185|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
1242186|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
1242187|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
1242188|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
1242189|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
1242190|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
1242191|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
1242192|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
1242250|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
1242193|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
1242194|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
1242195|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
1242196|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
1242197|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
1242198|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
1242265|NCT00113490|O1|Outcome|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
1242199|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
1242200|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
1242201|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
1242202|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
1242203|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
1242204|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
1242205|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
1242206|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
1242207|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
1242208|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
1242209|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
1242210|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
1242266|NCT00113490|O2|Outcome|Palivizumab 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
1242211|NCT00113529|E1|Reported Event|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
1242212|NCT00113516|B1|Baseline|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
1242213|NCT00113516|P2|Participant Flow|Sunitinib|Sunitinib 50 mg
1242214|NCT00113516|P1|Participant Flow|Carboplatin Plus Paclitaxel|Carboplatin Plus Paclitaxel 172-225 mg/m2
1242215|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
1242216|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
1242217|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
1242218|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
1242219|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
1242220|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
1242221|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
1242222|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
1242223|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
1242224|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
1242225|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
1242226|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
1242227|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
1242228|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
1242229|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
1242230|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
1242231|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
1242232|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
1242233|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
1242234|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
1242235|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
1242236|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
1242237|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
1242238|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
1242239|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
1242240|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
1242241|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
1242255|NCT00113490|B2|Baseline|Palivizumab 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
1242256|NCT00113490|B1|Baseline|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
1242257|NCT00113490|P2|Participant Flow|Palivizumab 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
1242258|NCT00113490|P1|Participant Flow|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
1242259|NCT00113490|O1|Outcome|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
1242260|NCT00113490|O2|Outcome|Palivizumab 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
1242261|NCT00113490|O1|Outcome|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
1242262|NCT00113490|O2|Outcome|Palivizumab 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
1242263|NCT00113490|O1|Outcome|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
1242264|NCT00113490|O2|Outcome|Palivizumab 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
1242794|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
1242267|NCT00113490|O1|Outcome|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
1242268|NCT00113490|E2|Reported Event|Palivizumab 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
1242269|NCT00113490|E1|Reported Event|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
1242270|NCT00113425|B1|Baseline|Treated Group Pulsed Dye Laser Therapy and Untreated Group|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face and the contralateral side of the face remained untreated, thus serving as an internal control.
1242271|NCT00113425|P1|Participant Flow|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
1242272|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
1242273|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
1242274|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
1242275|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
1242276|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
1242277|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
1242278|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
1242279|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
1242280|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
1242281|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
1242282|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
1242283|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
1242284|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
1242285|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
1242286|NCT00113425|E2|Reported Event|Untreated Group Control|The contralateral side of the face remained untreated, thus serving as an internal control.
1242287|NCT00113425|E1|Reported Event|Treated Group Pulsed Dye Laser Therapy|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face.
1242288|NCT00113399|B3|Baseline|Total|Total of all reporting groups
1242289|NCT00113399|B2|Baseline|Chemotherapy Alone|"Select from one of the three standard chemotherapy regimens:~cisplatin/5-FU; cisplatin/paclitaxel; cisplatin/docetaxel. [Data is reported for eligible patients with on-study information, which is 7 patients.]"
1242290|NCT00113399|B1|Baseline|Re-irradiation Plus Concurrent Chemotherapy|Radiation Therapy on weeks 1, 3, 5, and 7 1.5 Gy/fx, twice daily x 5 days, 40 fractions, for a total dose of 60 Gy; Chemotherapy (cisplatin/paclitaxel) on weeks 1, 3, 5, and 7 G-CSF on weeks 2, 4, 6, and 8. [Data is reported for eligible patients with on-study information, which is 6 patients.]
1242291|NCT00113399|P2|Participant Flow|Chemotherapy Alone|"Select from one of the three standard chemotherapy regimens:~cisplatin/5-FU; cisplatin/paclitaxel; cisplatin/docetaxel. [Data is reported for eligible patients with adverse event information, which is 7 patients.]"
1242292|NCT00113399|P1|Participant Flow|Re-irradiation Plus Concurrent Chemotherapy|Radiation Therapy on weeks 1, 3, 5, and 7; 1.5 Gy/fx, twice daily x 5 days, 40 fractions, for a total dose of 60 Gy; Chemotherapy (cisplatin/paclitaxel) on weeks 1, 3, 5, and 7 G-CSF on weeks 2, 4, 6, and 8. [Data is reported for eligible patients with adverse event information, which is 6 patients.]
1242293|NCT00113399|O2|Outcome|Chemotherapy Alone|"Select from one of the three standard chemotherapy regimens:~cisplatin/5-FU; cisplatin/paclitaxel; cisplatin/docetaxel"
1242795|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
1242796|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
1242294|NCT00113399|O1|Outcome|Re-irradiation Plus Concurrent Chemotherapy|Radiation Therapy on weeks 1, 3, 5, and 7 1.5 Gy/fx, twice daily x 5 days, 40 fractions, for a total dose of 60 Gy Chemotherapy (cisplatin/paclitaxel) on weeks 1, 3, 5, and 7 G-CSF on weeks 2, 4, 6, and 8
1242295|NCT00113399|E2|Reported Event|Chemotherapy Alone|"Select from one of the three standard chemotherapy regimens:~cisplatin/5-FU; cisplatin/paclitaxel; cisplatin/docetaxel. [Data is reported for eligible patients with adverse event information, which is 7 patients.]"
1242296|NCT00113399|E1|Reported Event|Re-irradiation Plus Concurrent Chemotherapy|Radiation Therapy on weeks 1, 3, 5, and 7; 1.5 Gy/fx, twice daily x 5 days, 40 fractions, for a total dose of 60 Gy; Chemotherapy (cisplatin/paclitaxel) on weeks 1, 3, 5, and 7 G-CSF on weeks 2, 4, 6, and 8. [Data is reported for eligible patients with adverse event information, which is 6 patients.]
1242297|NCT00113386|B3|Baseline|Total|Total of all reporting groups
1242298|NCT00113386|B2|Baseline|Preoperative Radiotherapy and Cisplatin/Docetaxel|Preoperative throacic radiation therapy 50.4 Gy concurrently with cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy and radiation therapy; docetaxel 4-6 weeks post-surgery. [Data is reported for eligible patients with on-study information, which is 7 patients.]
1242299|NCT00113386|B1|Baseline|Preoperative Cisplatin/Docetaxel|Preoperative cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy; docetaxel 4-6 weeks post-surgery [Data is reported for eligible patients with on-study information, which is 8 patients.]
1242300|NCT00113386|P2|Participant Flow|Preoperative Radiotherapy and Cisplatin/Docetaxel|Preoperative (induction) throacic radiation therapy 50.4 Gy concurrently with cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy and radiation therapy; docetaxel 4-6 weeks post-surgery.
1242301|NCT00113386|P1|Participant Flow|Preoperative Cisplatin/Docetaxel|Preoperative (induction) cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy; docetaxel 4-6 weeks post-surgery
1242302|NCT00113386|O2|Outcome|Preoperative Radiotherapy and Cisplatin/Docetaxel|Preoperative throacic radiation therapy 50.4 Gy concurrently with cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy and radiation therapy; docetaxel 4-6 weeks post-surgery.
1242303|NCT00113386|O1|Outcome|Preoperative Cisplatin/Docetaxel|Preoperative cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy; docetaxel 4-6 weeks post-surgery
1242304|NCT00113386|E2|Reported Event|Preoperative Radiotherapy and Cisplatin/Docetaxel|Preoperative throacic radiation therapy 50.4 Gy concurrently with cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy and radiation therapy; docetaxel 4-6 weeks post-surgery. [Data is reported for eligible patients with adverse event information, which is 7 patients.]
1242305|NCT00113386|E1|Reported Event|Preoperative Cisplatin/Docetaxel|Preoperative cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy; docetaxel 4-6 weeks post-surgery. [Data is reported for eligible patients with adverse event information, which is 9 patients.]
1242306|NCT00113373|B1|Baseline|Lapatinib|1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
1242307|NCT00113373|P1|Participant Flow|Lapatinib|1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
1242308|NCT00113373|O1|Outcome|Lapatinib|1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
1242309|NCT00113373|O1|Outcome|Lapatinib|1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
1242310|NCT00113373|O1|Outcome|Lapatinib|1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
1242311|NCT00113373|E1|Reported Event|Lapatinib|1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
1242312|NCT00113360|B1|Baseline|RAD001 Plus Octreotide Depot|RAD001 at 5 or 10 milligrams orally once a day plus Octreotide Depot 30 milligrams intramuscularly once every 28 days
1242313|NCT00113360|P1|Participant Flow|RAD001 Plus Octreotide Depot|RAD001 at 5 or 10 milligrams orally once a day plus Octreotide Depot 30 milligrams intramuscularly once every 28 days
1242314|NCT00113360|O1|Outcome|RAD001 Plus Octreotide Depot|RAD001 at 5 or 10 milligrams orally once a day plus Octreotide Depot 30 milligrams intramuscularly once every 28 days
1242315|NCT00113360|E1|Reported Event|RAD001 Plus Octreotide Depot|RAD001 at 5 or 10 milligrams orally once a day plus Octreotide Depot 30 milligrams intramuscularly once every 28 days
1242316|NCT00113334|B1|Baseline|ABT-510 (Thrombospondin)|Fixed dose level of thrombospondin 100 mg subcutaneously twice daily.
1242318|NCT00113334|O1|Outcome|ABT-510 (Thrombospondin)|Fixed dose level of thrombospondin 100 mg subcutaneously twice daily.
1242319|NCT00113334|E1|Reported Event|ABT-510 (Thrombospondin)|Fixed dose level of thrombospondin 100 mg subcutaneously twice daily.
1242320|NCT00113321|B1|Baseline|Decitabine|20 mg/m2 by vein (IV) over 1 hour daily x 5 days.
1242321|NCT00113321|P1|Participant Flow|Decitabine|20 mg/m2 by vein (IV) over 1 hour daily x 5 days.
1242322|NCT00113321|O1|Outcome|Decitabine|20 mg/m2 by vein (IV) over 1 hour daily x 5 days.
1242323|NCT00113321|E1|Reported Event|Decitabine|20 mg/m2 by vein (IV) over 1 hour daily x 5 days.
1242324|NCT00113295|B3|Baseline|Total|Total of all reporting groups
1242325|NCT00113295|B2|Baseline|Placebo Augmentation of Continued Paroxetine|Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
1242326|NCT00113295|B1|Baseline|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
1242327|NCT00113295|P2|Participant Flow|Placebo Augmentation of Continued Paroxetine|In the first phase of the study, individuals started at 12.5 mg/day of paroxetine and flexibly titrated up to a maximum of 62.5 mg/day by week 10. Individuals who did not achieve remission and were randomized into the placebo group received placebo augmentation of continued paroxetine CR at the week 10 dose level.
1242359|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
1256660|NCT00065429|B3|Baseline|IMGN 20 mg/m2|Arm 3, Phase 1
1242328|NCT00113295|P1|Participant Flow|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|In the first phase of the study, individuals started at 12.5 mg/day of paroxetine and flexibly tirated up to a maximum of 62.5 mg/day by week 10. Individuals who did not receive remission and were randomized to receive quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
1242329|NCT00113295|O2|Outcome|Placebo Augmentation of Continued Paroxetine|Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
1242330|NCT00113295|O1|Outcome|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16(mean±SD endpoint dose=120.5±100.5 mg/day).
1242331|NCT00113295|O2|Outcome|Placebo Augmentation of Continued Paroxetine|Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
1242332|NCT00113295|O1|Outcome|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
1242333|NCT00113295|O2|Outcome|Placebo Augmentation of Continued Paroxetine|Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
1242334|NCT00113295|O1|Outcome|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
1242335|NCT00113295|O2|Outcome|Placebo Augmentation of Continued Paroxetine|Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
1242336|NCT00113295|O1|Outcome|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16(mean±SD endpoint dose=120.5±100.5 mg/day).
1242337|NCT00113295|O2|Outcome|Placebo Augmentation of Continued Paroxetine|Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
1242338|NCT00113295|O1|Outcome|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
1242339|NCT00113295|E3|Reported Event|Paroxetine|Individuals received paroxetine CR for 10 weeks in Phase 1 of the study, initiated at 12.5 mg and flexibly titrated up to a maximum of 62.5 mg/day by week 8.
1242340|NCT00113295|E2|Reported Event|Placebo Augmentation of Continued Paroxetine|Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
1242341|NCT00113295|E1|Reported Event|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
1242342|NCT00113269|B5|Baseline|Total|Total of all reporting groups
1242343|NCT00113269|B4|Baseline|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
1242344|NCT00113269|B3|Baseline|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
1242345|NCT00113269|B2|Baseline|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
1242346|NCT00113269|B1|Baseline|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
1242347|NCT00113269|P4|Participant Flow|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
1242348|NCT00113269|P3|Participant Flow|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
1242349|NCT00113269|P2|Participant Flow|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
1242856|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
1242350|NCT00113269|P1|Participant Flow|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
1242351|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
1242352|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
1242353|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
1242354|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
1242355|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
1242356|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
1242357|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
1242358|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
1256661|NCT00065429|B2|Baseline|IMGN 10 mg/m2|Arm 2, Phase 1
1242360|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
1242361|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
1242362|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
1242363|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
1242364|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
1242365|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
1242366|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
1242367|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
1242368|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
1242369|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
1242370|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
1242371|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
1242372|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
1242373|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
1242374|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
1242375|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
1242376|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
1242377|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
1242378|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
1242379|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
1242380|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
1242381|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
1242382|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
1242383|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
1242384|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
1242385|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
1242386|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
1242387|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
1242388|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
1242389|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
1242390|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
1242391|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
1256662|NCT00065429|B1|Baseline|IMGN 5 mg/m2|Arm 1, Phase 1
1242392|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
1242393|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
1242394|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
1242395|NCT00113269|E4|Reported Event|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
1242396|NCT00113269|E3|Reported Event|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
1242397|NCT00113269|E2|Reported Event|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
1242398|NCT00113269|E1|Reported Event|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
1242399|NCT00113230|B1|Baseline|Avastin|Neoadjuvant therapy with radiotherapy (50.4 Gy in 28 fractions over 5.5 weeks), Avastin every 2 weeks (3 doses of 5 mg/kg), and capecitabine (900 mg/m2 orally twice daily only on days of radiation) followed by surgical resection.
1242400|NCT00113230|P1|Participant Flow|Avastin|Neoadjuvant therapy with radiotherapy (50.4 Gy in 28 fractions over 5.5 weeks), Avastin every 2 weeks (3 doses of 5 mg/kg), and capecitabine (900 mg/m2 orally twice daily only on days of radiation) followed by surgical resection.
1242401|NCT00113230|O1|Outcome|Avastin|Neoadjuvant therapy with radiotherapy (50.4 Gy in 28 fractions over 5.5 weeks), Avastin every 2 weeks (3 doses of 5 mg/kg), and capecitabine (900 mg/m2 orally twice daily only on days of radiation) followed by surgical resection.
1242402|NCT00113230|E1|Reported Event|Avastin|Neoadjuvant therapy with radiotherapy (50.4 Gy in 28 fractions over 5.5 weeks), Avastin every 2 weeks (3 doses of 5 mg/kg), and capecitabine (900 mg/m2 orally twice daily only on days of radiation) followed by surgical resection.
1242403|NCT00113217|B1|Baseline|Bevacizumab|10 mg/kg intravenous (IV) Day 1 of 14-day cycle.
1242404|NCT00113217|P1|Participant Flow|Bevacizumab|10 mg/kg intravenous (IV) Day 1 of 14-day cycle.
1242405|NCT00113217|O1|Outcome|Bevacizumab|10 mg/kg intravenous (IV) Day 1 of 14-day cycle.
1242406|NCT00113217|E1|Reported Event|Bevacizumab|10 mg/kg intravenous (IV) Day 1 of 14-day cycle.
1242407|NCT00113087|B3|Baseline|Total|Total of all reporting groups
1242408|NCT00113087|B2|Baseline|Placebo|Placebo suspension
1242409|NCT00113087|B1|Baseline|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
1242410|NCT00113087|P2|Participant Flow|Placebo|Placebo suspension
1242411|NCT00113087|P1|Participant Flow|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
1242412|NCT00113087|O2|Outcome|Placebo|Placebo suspension
1242413|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
1242414|NCT00113087|O2|Outcome|Placebo|Placebo suspension
1242415|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
1242416|NCT00113087|O2|Outcome|Placebo|Placebo suspension
1242417|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
1242418|NCT00113087|O2|Outcome|Placebo|Placebo suspension
1242419|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
1242420|NCT00113087|O2|Outcome|Placebo|Placebo suspension
1242857|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
1242421|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
1242422|NCT00113087|O2|Outcome|Placebo|Placebo suspension
1242423|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
1242424|NCT00113087|O2|Outcome|Placebo|Placebo suspension
1242425|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
1242426|NCT00113087|O2|Outcome|Placebo|Placebo suspension
1242427|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
1242428|NCT00113087|O2|Outcome|Placebo|Placebo suspension
1242429|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
1242430|NCT00113087|O2|Outcome|Placebo|Placebo suspension
1242431|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
1242432|NCT00113087|O2|Outcome|Placebo|Placebo suspension
1242433|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
1242434|NCT00113087|O2|Outcome|Placebo|Placebo suspension
1242797|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
1242435|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
1242436|NCT00113087|O2|Outcome|Placebo|Placebo suspension
1242437|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
1242438|NCT00113087|O2|Outcome|Placebo|Placebo suspension
1242439|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
1242440|NCT00113087|O2|Outcome|Placebo|Placebo suspension
1242441|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
1242442|NCT00113087|O2|Outcome|Placebo|Placebo suspension
1242443|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
1242444|NCT00113087|O2|Outcome|Placebo|Placebo suspension
1242445|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
1242446|NCT00113087|O2|Outcome|Placebo|Placebo suspension
1242447|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
1242448|NCT00113087|O2|Outcome|Placebo|Placebo suspension
1242449|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
1242450|NCT00113087|O2|Outcome|Placebo|Placebo suspension
1242451|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
1242452|NCT00113087|O2|Outcome|Placebo|Placebo suspension
1242453|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
1242454|NCT00113087|O2|Outcome|Placebo|Placebo suspension
1242455|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
1242456|NCT00113087|O2|Outcome|Placebo|Placebo suspension
1242457|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
1242458|NCT00113087|O2|Outcome|Placebo|Placebo suspension
1242459|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
1242460|NCT00113087|O2|Outcome|Placebo|Placebo suspension
1242461|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
1242462|NCT00113087|O2|Outcome|Placebo|Placebo suspension
1242463|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
1242464|NCT00113087|O2|Outcome|Placebo|Placebo suspension
1242465|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
1242466|NCT00113087|O2|Outcome|Placebo|Placebo suspension
1242467|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
1242468|NCT00113087|O2|Outcome|Placebo|Placebo suspension
1242858|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
1242469|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
1242470|NCT00113087|E2|Reported Event|Placebo|Placebo suspension
1242471|NCT00113087|E1|Reported Event|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
1242472|NCT00113022|B3|Baseline|Total|Total of all reporting groups
1242473|NCT00113022|B2|Baseline|Placebo|Blinded placebo. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
1242474|NCT00113022|B1|Baseline|Org 24448|Blinded, active experimental compound. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
1242475|NCT00113022|P2|Participant Flow|Placebo|Blinded placebo. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
1242571|NCT00112736|O2|Outcome|Phase 1 - 25 mg|Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (25mg). Every 28 days until disease progression or unacceptable toxicity.
1242476|NCT00113022|P1|Participant Flow|Org 24448|Blinded, active experimental compound. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
1242477|NCT00113022|O2|Outcome|Placebo|Blinded placebo. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
1242478|NCT00113022|O1|Outcome|Org 24448|Blinded, active experimental compound. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
1242479|NCT00113022|E2|Reported Event|Placebo|Blinded placebo. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
1242480|NCT00113022|E1|Reported Event|Org 24448|Blinded, active experimental compound. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
1242481|NCT00112918|B4|Baseline|Total|Total of all reporting groups
1242482|NCT00112918|B3|Baseline|XELOX+Bv|"Weeks 1–24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 – 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).~Weeks 25–48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
1242483|NCT00112918|B2|Baseline|FOLFOX4 + Bv|"Weeks 1–24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 – 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25–48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
1242484|NCT00112918|B1|Baseline|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-fluorouracil (5-FU), given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Observation only."
1242561|NCT00112736|B2|Baseline|Phase II n=16|"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity.~Anaplastic Glioma~erlotinib: Given orally~temsirolimus: Given IV"
1242485|NCT00112918|P3|Participant Flow|XELOX+Bv|"Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
1242486|NCT00112918|P2|Participant Flow|FOLFOX4 + Bv|"Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
1242487|NCT00112918|P1|Participant Flow|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-fluorouracil (5-FU), given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Observation only."
1242572|NCT00112736|O1|Outcome|Phase 1 - 50mg|Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (50mg). Every 28 days until disease progression or unacceptable toxicity.
1242798|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
1242799|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
1242488|NCT00112918|O3|Outcome|XELOX+Bv|"Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
1242489|NCT00112918|O2|Outcome|FOLFOX4 + Bv|"Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
1242490|NCT00112918|O1|Outcome|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Observation only."
1242491|NCT00112918|O3|Outcome|XELOX+Bv|"Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
1242492|NCT00112918|O2|Outcome|FOLFOX4 + Bv|"Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
1242493|NCT00112918|O1|Outcome|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Observation only."
1242528|NCT00112866|O2|Outcome|Group II Pre-op (High-dose Cilengitide) 2000mg|"Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (2000mg)~Resection: All patients undergo tumor resection on day 0.~cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection laboratory biomarker analysis: Correlative studies"
1242859|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
1242494|NCT00112918|O3|Outcome|XELOX+Bv|"Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
1242495|NCT00112918|O2|Outcome|FOLFOX4 + Bv|"Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
1242496|NCT00112918|O1|Outcome|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Observation only."
1242497|NCT00112918|O3|Outcome|XELOX+Bv|"Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
1242800|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
1242498|NCT00112918|O2|Outcome|FOLFOX4 + Bv|"Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
1242499|NCT00112918|O1|Outcome|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Observation only."
1242500|NCT00112918|O3|Outcome|XELOX+Bv|"Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
1242501|NCT00112918|O2|Outcome|FOLFOX4 + Bv|"Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
1242502|NCT00112918|O1|Outcome|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Observation only."
1242503|NCT00112918|O3|Outcome|XELOX+Bv|"Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
1242504|NCT00112918|O2|Outcome|FOLFOX4 + Bv|"Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
1242505|NCT00112918|O1|Outcome|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Observation only."
1242506|NCT00112918|E3|Reported Event|XELOX+Bv|"Weeks 1–24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 – 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).~Weeks 25–48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
1242507|NCT00112918|E2|Reported Event|FOLFOX4 + Bv|"Weeks 1–24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 – 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25–48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
1256663|NCT00065429|P7|Participant Flow|IMGN 75 mg/m2|Arm 7, Phase 1
1242508|NCT00112918|E1|Reported Event|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with Leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Observation only."
1242509|NCT00112905|B1|Baseline|TCC Cohort|"Only eligible and treated patients are included in the analysis.~BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies."
1242510|NCT00112905|P1|Participant Flow|TCC (Transitional Cell Carcinoma) Cohort|Sorafenib was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If sorafenib was taken with meals, patients were instructed to take sorafenib tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies. Patients were instructed to keep a pill diary and record the pills they took each day.
1242511|NCT00112905|O1|Outcome|TCC Cohort|"Only eligible and treated patients are included in the analysis.~BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies."
1242512|NCT00112905|O1|Outcome|TCC Cohort|"Only eligible and treated patients are included in the analysis.~BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies."
1242513|NCT00112905|O1|Outcome|TCC Cohort|"Only eligible and treated patients are included in the analysis.~BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies."
1242514|NCT00112905|O1|Outcome|TCC Cohort|"Only eligible and treated patients are included in the analysis.~BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies."
1242529|NCT00112866|O1|Outcome|Group I Pre-op (Low-dose Cilengitide) 500mg|"Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (low dose 500mg)~Resection: All patients undergo tumor resection on day 0.~cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection~laboratory biomarker analysis: Correlative studies"
1242515|NCT00112905|E1|Reported Event|TCC Cohort|"Only eligible and treated patients are included in the analysis.~BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies."
1242516|NCT00112866|B3|Baseline|Total|Total of all reporting groups
1242517|NCT00112866|B2|Baseline|High Dose 2000mg Group 2|"Preoperative Treatment: Patients receive high-dose 2000mg cilengitide IV over 1 hour on days -8, -4, and -1.~Resection: All patients undergo tumor resection on day 0.~Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~therapeutic conventional surgery: Undergo tumor resection~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1242518|NCT00112866|B1|Baseline|Low Dose 500mg Group 1|"Preoperative Treatment: Patients receive low dose 500mg cilengitide IV over 1 hour on days -8, -4, and -1.~Resection: All patients undergo tumor resection on day 0.~Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~therapeutic conventional surgery: Undergo tumor resection~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1242519|NCT00112866|P2|Participant Flow|High Dose 2000mg Group 2|"Preoperative Treatment: Patients receive high-dose cilengitide 2000mg IV over 1 hour on days -8, -4, and -1.~Resection: All patients undergo tumor resection on day 0.~Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~therapeutic conventional surgery: Undergo tumor resection~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1242520|NCT00112866|P1|Participant Flow|Low Dose 500mg Group 1|"Preoperative Treatment: Patients receive low dose cilengitide 500mg IV over 1 hour on days -8, -4, and -1.~Resection: All patients undergo tumor resection on day 0.~Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose cilengitide 2000mg IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~therapeutic conventional surgery: Undergo tumor resection~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1242801|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
1242802|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
1242803|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
1242521|NCT00112866|O1|Outcome|Post-Operative Treatment 2000mg|"Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~therapeutic conventional surgery: Undergo tumor resection~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1242522|NCT00112866|O2|Outcome|Group II (High-dose Cilengitide) 2000mg|"Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (2000mg)~Resection: All patients undergo tumor resection on day 0.~Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity~cilengitide: Given IV~therapeutic conventional surgery: Undergo tumor resection~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1242523|NCT00112866|O1|Outcome|Group I (Low-dose Cilengitide) 500mg|"Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (low dose 500mg)~Resection: All patients undergo tumor resection on day 0.~Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~therapeutic conventional surgery: Undergo tumor resection~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1242524|NCT00112866|O2|Outcome|Group II High-dose Cilengitide) 2000mg|"Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (2000mg)~Resection: All patients undergo tumor resection on day 0.~Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity~cilengitide: Given IV~therapeutic conventional surgery: Undergo tumor resection~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1242525|NCT00112866|O1|Outcome|Group I (Low-dose Cilengitide) 500mg|"Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (High dose 2000mg)~Resection: All patients undergo tumor resection on day 0.~Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive 2000mg high-dose cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~therapeutic conventional surgery: Undergo tumor resection~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1242526|NCT00112866|O2|Outcome|Group I Pre-op (Low-dose Cilengitide) 500mg|"Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (low dose 500mg)~Resection: All patients undergo tumor resection on day 0.~cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection~laboratory biomarker analysis: Correlative studies"
1242527|NCT00112866|O1|Outcome|Group II Pre-op (High-dose Cilengitide) 2000mg|"Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (2000mg)~Resection: All patients undergo tumor resection on day 0.~cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection laboratory biomarker analysis: Correlative studies"
1242530|NCT00112866|O2|Outcome|Group II Pre-op (High-dose Cilengitide) 2000mg|"Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (low dose 500mg)~Resection: All patients undergo tumor resection on day 0.~cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection~laboratory biomarker analysis: Correlative studies"
1242531|NCT00112866|O1|Outcome|Group I Pre-op (Low-dose Cilengitide) 500mg|"Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (low dose 500mg)~Resection: All patients undergo tumor resection on day 0.~cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection~laboratory biomarker analysis: Correlative studies"
1242532|NCT00112866|O2|Outcome|Group II Pre-op (High-dose Cilengitide) 2000mg|"Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (2000mg)~Resection: All patients undergo tumor resection on day 0.~cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection laboratory biomarker analysis: Correlative studies"
1242533|NCT00112866|O1|Outcome|Group I Pre-op (Low-dose Cilengitide) 500mg|"Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (low dose 500mg)~Resection: All patients undergo tumor resection on day 0.~cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection~laboratory biomarker analysis: Correlative studies"
1242534|NCT00112866|O2|Outcome|Group II Pre-op (High-dose Cilengitide) 2000mg|"Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (2000mg)~Resection: All patients undergo tumor resection on day 0.~cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection laboratory biomarker analysis: Correlative studies"
1242535|NCT00112866|O1|Outcome|Group I Pre-op (Low-dose Cilengitide) 500mg|"Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (low dose 500mg)~Resection: All patients undergo tumor resection on day 0.~cilengitide: Given IV therapeutic conventional surgery: Undergo tumor resection~laboratory biomarker analysis: Correlative studies"
1242536|NCT00112866|O1|Outcome|Post-Operative Treatment 2000mg|"Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~pharmacological study: Correlative studies"
1242804|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
1256664|NCT00065429|P6|Participant Flow|IMGN 67.5 mg/m2|Arm 6, Phase 1
1242537|NCT00112866|E1|Reported Event|Post-Operative 2000mg|"Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive high-dose 2000mg cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cilengitide: Given IV~therapeutic conventional surgery: Undergo tumor resection~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
1242538|NCT00112840|B4|Baseline|Total|Total of all reporting groups
1242539|NCT00112840|B3|Baseline|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
1242540|NCT00112840|B2|Baseline|Phase I, Dose Level 2|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1242541|NCT00112840|B1|Baseline|Phase I, Dose Level 1|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 1 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1242542|NCT00112840|P3|Participant Flow|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
1242543|NCT00112840|P2|Participant Flow|Phase I, Dose Level 2|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1= 10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1242544|NCT00112840|P1|Participant Flow|Phase I, Dose Level 1|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 1 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1242545|NCT00112840|O3|Outcome|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
1242546|NCT00112840|O2|Outcome|Phase I, Dose Level 2|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1242560|NCT00112736|B3|Baseline|Phase II n=43|"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity.~Glioblastoma~erlotinib: Given orally~temsirolimus: Given IV"
1242860|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
1242547|NCT00112840|O1|Outcome|Phase 1, Dose Level 1|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 in escalating dose levels to determine Maximum Tolerated Dose (MTD). In the phase I portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and doses of IV Bevacizumab (level 1=5mg/kg; level 2=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. The first three patients began at dose level 1 and cohort doses escalate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
1242548|NCT00112840|O1|Outcome|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
1242549|NCT00112840|O1|Outcome|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
1242550|NCT00112840|O3|Outcome|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
1242551|NCT00112840|O2|Outcome|Phase 1, Dose Level 2|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1242573|NCT00112736|O1|Outcome|Phase I - Dose Escalation|"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at (dose escalation or dose de-escalation). Every 28 days until disease progression or unacceptable toxicity.~Dose levels: cohort 1 - 50mg - 3pts cohort 2 - 25mg -6pt cohort 3 - 15mg - 12pts"
1242805|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
1242552|NCT00112840|O1|Outcome|Phase I, Dose Level 1|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 in escalating dose levels to determine Maximum Tolerated Dose (MTD). In the phase I portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and escalating doses of IV Bevacizumab (level 1=5mg/kg; level 2=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. The first three patients began at dose level 1 and cohort doses escalate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
1242553|NCT00112840|O3|Outcome|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
1242554|NCT00112840|O2|Outcome|Phase 1 , Dose Level 2|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1242555|NCT00112840|O1|Outcome|Phase I, Dose Level 1|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 in escalating dose levels to determine Maximum Tolerated Dose (MTD). In the phase I portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and doses of IV Bevacizumab (level 1=5mg/kg; level 2=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. The first three patients began at dose level 1 and cohort doses escalate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
1242556|NCT00112840|E3|Reported Event|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
1242557|NCT00112840|E2|Reported Event|Phase I, Dose Level 2|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1242558|NCT00112840|E1|Reported Event|Phase I, Dose Level 1|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 1 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1242559|NCT00112736|B4|Baseline|Total|Total of all reporting groups
1242861|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
1242562|NCT00112736|B1|Baseline|Phase I n=9|"PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (dose escalation). Every 28 days until disease progression or unacceptable toxicity.~erlotinib: Given orally~temsirolimus: Given IV"
1242563|NCT00112736|P2|Participant Flow|Phase II (Erlotinib & Temsirolimus)|"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity.~PHASE II (preoperative component): Patients who are surgical candidates may opt to undergo surgical resection of the tumor. Beginning 5-7 days before surgery, these patients receive oral erlotinib once daily until surgery. Patients also receive temsirolimus IV over 30 minutes at the MTD and then undergo surgical resection of the tumor 3-24 hours later. Beginning 2-4 weeks after surgery, patients receive temsirolimus at the MTD and erlotinib as in phase I.~therapeutic conventional surgery: Undergo surgical resection~laboratory biomarker analysis: Correlative studies"
1242564|NCT00112736|P1|Participant Flow|Phase I (Erlotinib & Temsirolimus)|"PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (dose escalation). Every 28 days until disease progression or unacceptable toxicity.~erlotinib: Given orally~temsirolimus: Given IV~pharmacological study: Correlative studies"
1242565|NCT00112736|O1|Outcome|Phase II n=43|"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity.~Glioblastoma~erlotinib: Given orally~temsirolimus: Given IV"
1242566|NCT00112736|O3|Outcome|Phase 1 - 50mg|Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (50mg). Every 28 days until disease progression or unacceptable toxicity.
1242567|NCT00112736|O2|Outcome|Phase 1 - 25 mg|Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (25mg). Every 28 days until disease progression or unacceptable toxicity.
1242568|NCT00112736|O1|Outcome|Phase 1 - 15mg|PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (15mg). Every 28 days until disease progression or unacceptable toxicity.
1242569|NCT00112736|O1|Outcome|Phase I 15mg Temsirolimus (MTD Dose)|"PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (15mg). Every 28 days until disease progression or unacceptable toxicity.~erlotinib: Given orally~temsirolimus: Given IV"
1242570|NCT00112736|O3|Outcome|Phase 1 - 15mg|PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (15mg). Every 28 days until disease progression or unacceptable toxicity.
1242574|NCT00112736|E2|Reported Event|Phase II (Erlotinib & Erlotinib)|"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity.~PHASE II (preoperative component): Patients who are surgical candidates may opt to undergo surgical resection of the tumor. Beginning 5-7 days before surgery, these patients receive oral erlotinib once daily until surgery. Patients also receive temsirolimus IV over 30 minutes at the MTD and then undergo surgical resection of the tumor 3-24 hours later. Beginning 2-4 weeks after surgery, patients receive temsirolimus at the MTD and erlotinib as in phase I.~therapeutic conventional surgery: Undergo surgical resection~laboratory biomarker analysis: Correlative studies"
1242575|NCT00112736|E1|Reported Event|Phase I (Erlotinib & Temsirolimus)|"PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (dose escalation). Every 28 days until disease progression or unacceptable toxicity.~erlotinib: Given orally~temsirolimus: Given IV~pharmacological study: Correlative studies"
1242576|NCT00112723|B1|Baseline|Treatment (Alvocidib)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.~alvocidib: Given IV"
1242577|NCT00112723|P3|Participant Flow|Dose Level 3 (Flavopiridol 50 mg/m2 + 50 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
1242578|NCT00112723|P2|Participant Flow|Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
1242579|NCT00112723|P1|Participant Flow|Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
1242580|NCT00112723|O1|Outcome|All Dose Levels of Alvocidib|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.~alvocidib: Given IV"
1242581|NCT00112723|O3|Outcome|Dose Level 3 (Flavopiridol 50 mg/m2 + 50 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
1242582|NCT00112723|O2|Outcome|Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
1242583|NCT00112723|O1|Outcome|Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
1242584|NCT00112723|O3|Outcome|Dose Level 3 (Flavopiridol 50 mg/m2 + 50 mg/m2)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
1242585|NCT00112723|O2|Outcome|Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
1242862|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
1242586|NCT00112723|O1|Outcome|Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
1242587|NCT00112723|O1|Outcome|All Dose Levels of Alvocidib|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.~alvocidib: Given IV"
1242588|NCT00112723|O1|Outcome|All Dose Levels of Alvocidib|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.~alvocidib: Given IV"
1242589|NCT00112723|O3|Outcome|Cohort 4|Patients diagnosed with T Cell NHL
1242590|NCT00112723|O2|Outcome|Cohort 2|Patients diagnosed with Mantle Cell NHL
1242591|NCT00112723|O1|Outcome|Cohort 1|Patients diagnosed with Indolent B-cell NHL
1242592|NCT00112723|O1|Outcome|Dose Levels 1, 2, 3|"Dose Level 1 (30 mg/m2 + 30 mg/m2), Dose Level 2 (30 mg/m2 + 50 mg/m2), Dose Level 3 (50 mg/m2 + 50 mg/m2)~PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.~alvocidib: Given IV"
1242593|NCT00112723|O3|Outcome|Dose Level 3 Dose (Flavopiridol 50 mg/m2 + 50 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
1242621|NCT00112489|E1|Reported Event|Paclitaxel Followed by Carboplatin|Paclitaxel 175 mg/m2 IV over 3 hours followed by Carboplatin AUC = 6 IV over 30 minutes repeated every 21 days until disease progression or adverse effects prohibit further therapy
1242806|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
1242807|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
1242594|NCT00112723|O2|Outcome|Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
1242595|NCT00112723|O1|Outcome|Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
1242596|NCT00112723|O3|Outcome|Level 3 (50+50)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
1242597|NCT00112723|O2|Outcome|Level 2 (30+50)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
1242598|NCT00112723|O1|Outcome|Dose Level 1 (30+30)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.~alvocidib: Given IV"
1242599|NCT00112723|O3|Outcome|Dose Level 3 (Flavopiridol 50 mg/m2 + 50 mg/m2)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
1242600|NCT00112723|O2|Outcome|Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
1242601|NCT00112723|O1|Outcome|Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
1242602|NCT00112723|E1|Reported Event|Treatment (Alvocidib)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.~alvocidib: Given IV"
1242603|NCT00112671|B1|Baseline|Treatment (Sorafenib Tosylate)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally~laboratory biomarker analysis: Correlative studies"
1242604|NCT00112671|P1|Participant Flow|Treatment (Sorafenib Tosylate)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally~laboratory biomarker analysis: Correlative studies"
1242863|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
1242864|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
1242605|NCT00112671|O1|Outcome|Treatment (Sorafenib Tosylate)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally~laboratory biomarker analysis: Correlative studies"
1242606|NCT00112671|O1|Outcome|Treatment (Sorafenib Tosylate)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally~laboratory biomarker analysis: Correlative studies"
1242607|NCT00112671|O1|Outcome|Treatment (Sorafenib Tosylate)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally~laboratory biomarker analysis: Correlative studies"
1242608|NCT00112671|E1|Reported Event|Treatment (Sorafenib Tosylate)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally~laboratory biomarker analysis: Correlative studies"
1242609|NCT00112593|B1|Baseline|Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0.~TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation~cyclosporine: Given IV or PO~mycophenolate mofetil: Given IV or PO~laboratory biomarker analysis: Correlative studies"
1242610|NCT00112593|P1|Participant Flow|Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0.~TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation~cyclosporine: Given IV or PO~mycophenolate mofetil: Given IV or PO~laboratory biomarker analysis: Correlative studies"
1242611|NCT00112593|O1|Outcome|Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0.~TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation~cyclosporine: Given IV or PO~mycophenolate mofetil: Given IV or PO~laboratory biomarker analysis: Correlative studies"
1242612|NCT00112593|O1|Outcome|Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0.~TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation~cyclosporine: Given IV or PO~mycophenolate mofetil: Given IV or PO~laboratory biomarker analysis: Correlative studies"
1242613|NCT00112593|O1|Outcome|Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0.~TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation~cyclosporine: Given IV or PO~mycophenolate mofetil: Given IV or PO~laboratory biomarker analysis: Correlative studies"
1242614|NCT00112593|O1|Outcome|Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0.~TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation~cyclosporine: Given IV or PO~mycophenolate mofetil: Given IV or PO~laboratory biomarker analysis: Correlative studies"
1242637|NCT00112437|P13|Participant Flow|MK0822 25 mg / MK0822 50 mg|"12 Month Extension (Year 3)~During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year."
1242865|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
1242615|NCT00112593|O1|Outcome|Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0.~TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation~cyclosporine: Given IV or PO~mycophenolate mofetil: Given IV or PO~laboratory biomarker analysis: Correlative studies"
1242616|NCT00112593|O1|Outcome|Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0.~TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation~cyclosporine: Given IV or PO~mycophenolate mofetil: Given IV or PO~laboratory biomarker analysis: Correlative studies"
1242617|NCT00112593|E1|Reported Event|Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)|"CONDITIONING REGIMEN: Patients receive fludarabine IV over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0.~TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of GVHD. Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~peripheral blood stem cell transplantation: Undergo allogeneic bone marrow or peripheral blood stem cell transplantation~cyclosporine: Given IV or PO~mycophenolate mofetil: Given IV or PO~laboratory biomarker analysis: Correlative studies"
1242618|NCT00112489|B1|Baseline|Paclitaxel Followed by Carboplatin|Paclitaxel 175 mg/m2 IV over 3 hours followed by Carboplatin AUC = 6 IV over 30 minutes repeated every 21 days until disease progression or adverse effects prohibit further therapy
1242619|NCT00112489|P1|Participant Flow|Paclitaxel Followed by Carboplatin|Paclitaxel 175 mg/m2 IV over 3 hours followed by Carboplatin AUC = 6 IV over 30 minutes repeated every 21 days until disease progression or adverse effects prohibit further therapy
1242620|NCT00112489|O1|Outcome|Paclitaxel Followed by Carboplatin|Paclitaxel 175 mg/m2 IV over 3 hours followed by Carboplatin AUC = 6 IV over 30 minutes repeated every 21 days until disease progression or adverse effects prohibit further therapy
1242622|NCT00112463|B1|Baseline|Treatment (Single-agent Depsipeptide)|Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
1242623|NCT00112463|P1|Participant Flow|Treatment (Single-agent Depsipeptide)|Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
1242624|NCT00112463|O1|Outcome|Treatment (Single-agent Depsipeptide)|Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
1242625|NCT00112463|O1|Outcome|Treatment (Single-agent Depsipeptide)|"Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.~romidepsin: DEP is administered at a dose of 13 mg/m2 as a 4-hour intravenous infusion in the outpatient setting."
1242626|NCT00112463|O1|Outcome|Treatment (Single-agent Depsipeptide)|Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
1242627|NCT00112463|O1|Outcome|Treatment (Single-agent Depsipeptide)|Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
1242628|NCT00112463|E1|Reported Event|Treatment (Single-agent Depsipeptide)|Patients receive depsipeptide (romidepsin) intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.
1242629|NCT00112437|B6|Baseline|Total|Total of all reporting groups
1242630|NCT00112437|B5|Baseline|MK0822 50 mg|50 mg MK0822 1 tablet once a week
1242631|NCT00112437|B4|Baseline|MK0822 25 mg|25 mg MK0822 1 tablet once a week
1242632|NCT00112437|B3|Baseline|MK0822 10 mg|10 mg MK0822 1 tablet once a week
1242633|NCT00112437|B2|Baseline|MK0822 3 mg|3 mg MK0822 1 tablet once a week
1242634|NCT00112437|B1|Baseline|Placebo|Placebo 1 tablet once a week
1242635|NCT00112437|P15|Participant Flow|MK0822 50 mg / MK0822 50 mg|"12 Month Extension (Year 3)~During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table~during 3 years."
1242636|NCT00112437|P14|Participant Flow|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
1242638|NCT00112437|P12|Participant Flow|MK0822 25 mg / Placebo|"12 Month Extension (Year 3)~During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year."
1242639|NCT00112437|P11|Participant Flow|MK0822 10 mg / MK0822 50 mg|"12 Month Extension (Year 3)~During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year."
1242640|NCT00112437|P10|Participant Flow|MK0822 10 mg / Placebo|"12 Month Extension (Year 3)~During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg~tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year."
1242641|NCT00112437|P9|Participant Flow|MK0822 3 mg / MK0822 50 mg|"12 Month Extension (Year 3)~During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year."
1242642|NCT00112437|P8|Participant Flow|MK0822 3 mg / Placebo|"12 Month Extension (Year 3)~During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year."
1242643|NCT00112437|P7|Participant Flow|Placebo / MK0822 50 mg|"12 Month Extension (Year 3)~During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year."
1242644|NCT00112437|P6|Participant Flow|Placebo / Placebo|"12 Month Extension (Year 3)~During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years."
1242645|NCT00112437|P5|Participant Flow|MK0822 50 mg|50 mg MK0822 1 tablet once a week
1242646|NCT00112437|P4|Participant Flow|MK0822 25 mg|25 mg MK0822 1 tablet once a week
1242647|NCT00112437|P3|Participant Flow|MK0822 10 mg|10 mg MK0822 1 tablet once a week
1242648|NCT00112437|P2|Participant Flow|MK0822 3 mg|3 mg MK0822 1 tablet once a week
1242649|NCT00112437|P1|Participant Flow|Placebo|Placebo 1 tablet once a week.
1242650|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
1242651|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
1242652|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
1242653|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
1242654|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
1242655|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
1242656|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
1242657|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
1242658|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
1242659|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
1242660|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
1242661|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
1242662|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
1242866|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
1242663|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
1242664|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
1242665|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
1242666|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
1242667|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
1242668|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
1242669|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
1242670|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
1242671|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
1242672|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
1242808|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
1242673|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
1242674|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
1242675|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
1242676|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
1242677|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
1242678|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
1242679|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
1242680|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
1242681|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
1242682|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
1242683|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
1242750|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
1242684|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
1242685|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
1242686|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
1242687|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
1242688|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
1242689|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
1242690|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
1242691|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
1242692|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
1242693|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
1242694|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
1242695|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
1242696|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
1242697|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
1242698|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
1242699|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
1242700|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
1242701|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
1242702|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
1242703|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
1242704|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
1242705|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
1242849|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
1242706|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
1242707|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
1242708|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
1242709|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
1242710|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
1242711|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
1242712|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
1242713|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
1242714|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
1242715|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
1242716|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
1242717|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
1242718|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
1242719|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
1242720|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
1242721|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
1242722|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
1242723|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
1242724|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
1242725|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
1242726|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
1242749|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
1242727|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
1242728|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
1242729|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
1242730|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
1242731|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
1242732|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
1242733|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
1242734|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
1242735|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
1242736|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
1242737|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
1242738|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
1242739|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
1242740|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
1242741|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
1242742|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
1242743|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
1242744|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
1242745|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
1242746|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
1242747|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
1242748|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
1242751|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
1242752|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
1242753|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
1242754|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
1242755|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
1242756|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
1242757|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
1242758|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
1242759|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
1242760|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
1242790|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
1242761|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
1242762|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
1242763|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
1242764|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
1242765|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
1242766|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
1242767|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
1242768|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
1242769|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
1242770|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
1242771|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
1242850|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
1242851|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
1242852|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
1242772|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
1242773|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
1242774|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
1242775|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
1242776|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
1242777|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
1242778|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
1242779|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
1242780|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
1242781|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
1242782|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
1242783|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
1242784|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
1242785|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
1242786|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
1242787|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
1242788|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
1242789|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
1242810|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
1242811|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
1242812|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
1242813|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
1242814|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
1242815|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
1242816|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
1242817|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
1242818|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
1242819|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
1242820|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
1242821|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
1242822|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
1242823|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
1242824|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
1242825|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
1242826|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
1242827|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
1242828|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
1242829|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
1242830|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
1242831|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
1242832|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
1242833|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
1242834|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
1242835|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
1242836|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
1242837|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
1242838|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
1242839|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
1242840|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
1242841|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
1242842|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
1242843|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
1242844|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
1242845|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
1242846|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
1242847|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
1242848|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
1242867|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
1242868|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
1242869|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
1242870|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
1242871|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
1242872|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
1242873|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
1242874|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
1242875|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
1242876|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
1242877|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
1242878|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
1242879|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
1242880|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
1242881|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
1242882|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
1242883|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
1242884|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
1242885|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
1242886|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
1242887|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
1242888|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
1242890|NCT00112437|E15|Reported Event|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
1242891|NCT00112437|E14|Reported Event|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
1242892|NCT00112437|E13|Reported Event|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
1242893|NCT00112437|E12|Reported Event|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
1242894|NCT00112437|E11|Reported Event|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
1242895|NCT00112437|E10|Reported Event|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
1242896|NCT00112437|E9|Reported Event|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
1242897|NCT00112437|E8|Reported Event|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
1242898|NCT00112437|E7|Reported Event|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
1242899|NCT00112437|E6|Reported Event|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
1242900|NCT00112437|E5|Reported Event|MK0822 50 mg|50 mg MK0822 1 tablet once a week
1242901|NCT00112437|E4|Reported Event|MK0822 25 mg|25 mg MK0822 1 tablet once a week
1242902|NCT00112437|E3|Reported Event|MK0822 10 mg|10 mg MK0822 1 tablet once a week
1242903|NCT00112437|E2|Reported Event|MK0822 3 mg|3 mg MK0822 1 tablet once a week
1242904|NCT00112437|E1|Reported Event|Placebo|Placebo 1 tablet once a week
1242905|NCT00112385|B3|Baseline|Total|Total of all reporting groups
1242906|NCT00112385|B2|Baseline|Placebo|Subjects will be given syringes containing placebo
1242907|NCT00112385|B1|Baseline|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242908|NCT00112385|P2|Participant Flow|Placebo|Subjects will be given syringes containing placebo
1242909|NCT00112385|P1|Participant Flow|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242910|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242911|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242912|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242913|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242914|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1243063|NCT00112294|E1|Reported Event|Cetuximab+Taxane+Carboplatin|
1242915|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242916|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242917|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242918|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242919|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242920|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242921|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242922|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242923|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242924|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242925|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242926|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242927|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242928|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242929|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242930|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242931|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242932|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242933|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242934|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242935|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242936|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242937|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242938|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242939|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242940|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242941|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242942|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242943|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242944|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242945|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242946|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242947|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242948|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242949|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242950|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242951|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242952|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242953|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242954|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242955|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242956|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242957|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242958|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242959|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242960|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242961|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242962|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242963|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242964|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242965|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242966|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242967|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242968|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242969|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242970|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242971|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242972|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242973|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242974|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242975|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242976|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242977|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242978|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242979|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242980|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242981|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242982|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242983|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242984|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242985|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242986|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242987|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242988|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242989|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242990|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242991|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242992|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
1242993|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242994|NCT00112385|E2|Reported Event|Placebo|Subjects will be given syringes containing placebo
1242995|NCT00112385|E1|Reported Event|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
1242996|NCT00112359|B3|Baseline|Total|Total of all reporting groups
1242997|NCT00112359|B2|Baseline|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
1242998|NCT00112359|B1|Baseline|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
1242999|NCT00112359|P2|Participant Flow|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
1243000|NCT00112359|P1|Participant Flow|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
1243001|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
1243002|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
1243003|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
1243004|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
1243005|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
1243006|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
1243007|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
1243008|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
1243009|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
1243010|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
1243011|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
1243012|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
1243013|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
1243014|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
1243513|NCT00110617|E1|Reported Event|Period 1 Deferasirox (ICL670)|Period 1 (first 24 weeks) Deferasirox (ICL670) 20 mg/kg orally once daily.
1243015|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
1243016|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
1243017|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
1243018|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
1243019|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
1243020|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
1243021|NCT00112359|E2|Reported Event|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
1243022|NCT00112359|E1|Reported Event|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
1243023|NCT00112294|B3|Baseline|Total|Total of all reporting groups
1243024|NCT00112294|B2|Baseline|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243025|NCT00112294|B1|Baseline|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243026|NCT00112294|P2|Participant Flow|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243027|NCT00112294|P1|Participant Flow|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243028|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243029|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243064|NCT00112151|B7|Baseline|Total|Total of all reporting groups
1243030|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243031|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243032|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243033|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243034|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243740|NCT00110305|O4|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
1243035|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243036|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243037|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243038|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243039|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243040|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243041|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243042|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243043|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243044|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243045|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1253272|NCT00083174|E2|Reported Event|Placebo|one tablet daily in am
1243046|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243047|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243048|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243049|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243050|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243654|NCT00110357|O3|Outcome|Group A 150/20|Cetuximab 150 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
1243051|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243052|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243053|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243054|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243055|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243056|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243057|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243058|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243059|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243060|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243061|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
1243062|NCT00112294|E2|Reported Event|Taxane+Carboplatin|
1243065|NCT00112151|B6|Baseline|Placebo+No Resistance Training|"Placebo group applies two 2.5 gm placebo packets~No exercise program"
1243066|NCT00112151|B5|Baseline|Placebo+Resistance Training|"Placebo Group applies two 2.5 gm placebo packets~1 year standard Progressive Resistance Training(PRT) program"
1243067|NCT00112151|B4|Baseline|HighT+No Resistance Training|"High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)~No exercise program"
1243068|NCT00112151|B3|Baseline|HighT+Resistance Training|"High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)~1 year standard Progressive Resistance Training(PRT) program"
1243069|NCT00112151|B2|Baseline|LowT+No Resistance Training|"Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)~No exercise program"
1243070|NCT00112151|B1|Baseline|LowT+Resistance Training|"Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)~1 year standard Progressive Resistance Training(PRT) program"
1243071|NCT00112151|P6|Participant Flow|Placebo+No Resistance Training|"Placebo group applies two 2.5 gm placebo packets~No exercise program"
1243072|NCT00112151|P5|Participant Flow|Placebo+Resistance Training|"Placebo Group applies two 2.5 gm placebo packets~1 year standard Progressive Resistance Training(PRT) program"
1243073|NCT00112151|P4|Participant Flow|HighT+No Resistance Training|"High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)~No exercise program"
1243074|NCT00112151|P3|Participant Flow|HighT+Resistance Training|"High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)~1 year standard Progressive Resistance Training(PRT) program"
1243075|NCT00112151|P2|Participant Flow|LowT+No Resistance Training|"Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)~No exercise program"
1243076|NCT00112151|P1|Participant Flow|LowT+Resistance Training|"Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)~1 year standard Progressive Resistance Training(PRT) program"
1243077|NCT00112151|O4|Outcome|Any T + PRT|T gel supplementation (lower- or higher-range) plus progressive resistance training
1243078|NCT00112151|O3|Outcome|Any T + No PRT|T gel supplementation (lower- or higher-range); no exercise
1243079|NCT00112151|O2|Outcome|Placebo + PRT|Placebo gel plus progressive resistance training
1243080|NCT00112151|O1|Outcome|Placebo + No PRT|Placebo gel; no exercise
1243081|NCT00112151|O4|Outcome|Any T + PRT|T gel supplementation (lower- or higher-range) plus progressive resistance training
1243082|NCT00112151|O3|Outcome|Any T + No PRT|T gel supplementation (lower- or higher-range); no exercise
1243083|NCT00112151|O2|Outcome|Placebo + PRT|Placebo gel plus progressive resistance training
1243084|NCT00112151|O1|Outcome|Placebo + No PRT|Placebo gel; no exercise
1243085|NCT00112151|O4|Outcome|Any T + PRT|T gel supplementation (lower- or higher-range) plus progressive resistance training
1243086|NCT00112151|O3|Outcome|Any T + No PRT|T gel supplementation (lower- or higher-range); no exercise
1243087|NCT00112151|O2|Outcome|Placebo + PRT|Placebo gel plus progressive resistance training
1243088|NCT00112151|O1|Outcome|Placebo + No PRT|Placebo gel; no exercise
1243089|NCT00112151|O4|Outcome|Any T + PRT|T gel supplementation (lower- or higher-range) plus progressive resistance training
1243090|NCT00112151|O3|Outcome|Any T + No PRT|T gel supplementation (lower- or higher-range); no exercise
1243091|NCT00112151|O2|Outcome|Placebo + PRT|Placebo gel plus progressive resistance training
1243092|NCT00112151|O1|Outcome|Placebo + No PRT|Placebo gel; no exercise
1243093|NCT00112151|O4|Outcome|Any T + PRT|T gel supplementation (lower- or higher-range) plus progressive resistance training
1243094|NCT00112151|O3|Outcome|Any T + No PRT|T gel supplementation (lower- or higher-range); no exercise
1243095|NCT00112151|O2|Outcome|Placebo + PRT|Placebo gel plus progressive resistance training
1243096|NCT00112151|O1|Outcome|Placebo + No PRT|Placebo gel; no exercise
1243097|NCT00112151|O4|Outcome|Any T + PRT|T gel supplementation (lower or higher-range) plus progressive resistance training
1243098|NCT00112151|O3|Outcome|Any T + No PRT|T gel supplementation (lower or higher-range); no exercise
1243099|NCT00112151|O2|Outcome|Placebo + PRT|Placebo gel plus progressive resistance training
1243100|NCT00112151|O1|Outcome|Placebo + No PRT|Placebo gel; no exercise
1243101|NCT00112151|E3|Reported Event|Higher-range T|T gel supplementation targeting a total serum T concentration of 600-1000ng/dL, with our without progressive resistance training
1243102|NCT00112151|E2|Reported Event|Lower-range T|T gel supplementation targeting a total serum T concentration of 400-550ng/dL, with our without progressive resistance training
1243103|NCT00112151|E1|Reported Event|Placebo|Placebo gel with or without progressive resistance training
1243104|NCT00112112|B3|Baseline|Total|Total of all reporting groups
1243105|NCT00112112|B2|Baseline|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243106|NCT00112112|B1|Baseline|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243107|NCT00112112|P2|Participant Flow|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243108|NCT00112112|P1|Participant Flow|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243375|NCT00111761|O1|Outcome|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
1254754|NCT00075725|B13|Baseline|Total|Total of all reporting groups
1243109|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243110|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243111|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243112|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243113|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243114|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243115|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243655|NCT00110357|O2|Outcome|Group A 150/16|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years of age
1243116|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243117|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243118|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243119|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243120|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243121|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243122|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243123|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243124|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243125|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243126|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243127|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243128|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243129|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243130|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243131|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243376|NCT00111761|O1|Outcome|Panitumumab With FOLFIRI|Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
1243377|NCT00111761|E2|Reported Event|Panitumumab Plus FOLFIRI|
1243132|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243133|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243134|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243135|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243136|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243137|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243138|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243139|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243741|NCT00110305|O3|Outcome|TMC278 150 mg|TMC278 150 mg once daily
1243140|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243141|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243142|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243143|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243144|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243145|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243146|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243147|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243148|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243149|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243150|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243151|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243152|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243153|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243154|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243155|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243156|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243157|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243158|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243159|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243160|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243161|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243162|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243163|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243742|NCT00110305|O2|Outcome|TMC278 75 mg|TMC278 75 mg once daily
1243164|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243165|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243166|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243167|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243168|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243169|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243170|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243171|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243172|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243173|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243174|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243175|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243176|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243177|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243178|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243179|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243180|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243181|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243182|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243183|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243184|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243185|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243186|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243187|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243743|NCT00110305|O1|Outcome|TMC278 25mg|TMC278 25 mg once daily
1243188|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243189|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243190|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243191|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243192|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243193|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243194|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243195|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243196|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243197|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243198|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243199|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243200|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243201|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
1243202|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
1243203|NCT00112112|E2|Reported Event|FluMist|
1243204|NCT00112112|E1|Reported Event|Placebo|
1243205|NCT00112047|B3|Baseline|Total|Total of all reporting groups
1243378|NCT00111761|E1|Reported Event|Panitumumab Plus IFL|
1243206|NCT00112047|B2|Baseline|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243207|NCT00112047|B1|Baseline|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243208|NCT00112047|P2|Participant Flow|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243656|NCT00110357|O1|Outcome|Group A 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years
1243209|NCT00112047|P1|Participant Flow|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243210|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
1243211|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
1243212|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
1243213|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
1243214|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
1243215|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
1243216|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
1243217|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
1243218|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
1243219|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
1243220|NCT00112047|O2|Outcome|All Atripla (From Atripla Baseline)|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
1243221|NCT00112047|O1|Outcome|EFV+FTC+TDF/Atripla (From Study Baseline)|Participants in this group were originally randomized to receive the 3 component drugs: efavirenz (EFV) + emtricitabine (FTC) + tenofovir disoproxil fumarate (tenofovir DF; TDF) for 96 weeks, and subsequently received Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF) and EFV until Week 144. Participants then rolled over into the further 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
1243324|NCT00111813|P4|Participant Flow|Vorinostat 400 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
1243222|NCT00112047|O2|Outcome|All Atripla (From Atripla Baseline)|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
1243223|NCT00112047|O1|Outcome|EFV+FTC+TDF/Atripla (From Study Baseline)|Participants in this group were originally randomized to receive the 3 component drugs: efavirenz (EFV) + emtricitabine (FTC) + tenofovir disoproxil fumarate (tenofovir DF; TDF) for 96 weeks, and subsequently received Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF) and EFV until Week 144. Participants then rolled over into the further 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
1243224|NCT00112047|O2|Outcome|All Atripla (From Atripla Baseline)|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
1243225|NCT00112047|O1|Outcome|EFV+FTC+TDF/Atripla (From Study Baseline)|Participants in this group were originally randomized to receive the 3 component drugs: efavirenz (EFV) + emtricitabine (FTC) + tenofovir disoproxil fumarate (tenofovir DF; TDF) for 96 weeks, and subsequently received Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF) and EFV until Week 144. Participants then rolled over into the further 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
1243226|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
1243227|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
1243228|NCT00112047|O2|Outcome|All Atripla (From Atripla Baseline)|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
1243238|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243229|NCT00112047|O1|Outcome|EFV+FTC+TDF/Atripla (From Study Baseline)|Participants in this group were originally randomized to receive the 3 component drugs: efavirenz (EFV) + emtricitabine (FTC) + tenofovir disoproxil fumarate (tenofovir DF; TDF) for 96 weeks, and subsequently received Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF) and EFV until Week 144. Participants then rolled over into the further 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
1243230|NCT00112047|O2|Outcome|All Atripla (From Atripla Baseline)|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
1243231|NCT00112047|O1|Outcome|EFV+FTC+TDF/Atripla (From Study Baseline)|Participants in this group were originally randomized to receive the 3 component drugs: efavirenz (EFV) + emtricitabine (FTC) + tenofovir disoproxil fumarate (tenofovir DF; TDF) for 96 weeks, and subsequently received Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF) and EFV until Week 144. Participants then rolled over into the further 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
1243232|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
1243233|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
1243439|NCT00110890|O1|Outcome|Cinacalcet|Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
1243234|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243235|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243236|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243237|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243304|NCT00112047|E2|Reported Event|FTC+TDF+EFV/ATR (Baseline to 240 Weeks)|Exposure to the component drugs EFV+FTC+TDF during the randomized treatment phase and during the Atripla treatment phase was up to 240 weeks (TVD replaced FTC+TDF at Week 96; ATR replaced TVD+EFV at Week 144). Exposure to ATR for 6 participants at sites in France was up to 288 weeks (this was due to a protocol amendment which allowed these participants to continue to receive ATR until it became commercially available). For this safety population, N=160.
1243379|NCT00111657|B1|Baseline|Single Arm - Pegloticase|
1243380|NCT00111657|P1|Participant Flow|Single Arm - Pegloticase|
1243239|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243240|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243241|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243325|NCT00111813|P3|Participant Flow|Vorinostat 300 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
1243469|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
1243242|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243243|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243244|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243245|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243246|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243247|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243248|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243249|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243326|NCT00111813|P2|Participant Flow|Vorinostat 200 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
1243470|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
1243657|NCT00110357|O2|Outcome|Group B (Ages 13-18 Years)|
1243658|NCT00110357|O1|Outcome|Group A (Ages 1-12 Years)|
1243250|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243251|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243252|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243253|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243254|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243255|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243256|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243257|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243327|NCT00111813|P1|Participant Flow|Vorinostat 200 mg + Bortezomib 0.7 mg/m^2|"Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
1243501|NCT00110617|P2|Participant Flow|Deferoxamine (DFO) Then ICL670|Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy.
1243258|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243259|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243260|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243261|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243262|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243263|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243264|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243265|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243328|NCT00111813|O6|Outcome|Vorinostat 400 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
1243502|NCT00110617|P1|Participant Flow|Deferasirox (ICL670)|Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks.
1243503|NCT00110617|O1|Outcome|Deferasirox (ICL670)|Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks.
1243266|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243267|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243268|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243269|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243270|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243271|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243272|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243273|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243329|NCT00111813|O5|Outcome|Vorinostat 400 mg + Bortezomib 1.1 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
1243504|NCT00110617|O2|Outcome|Deferoxamine (DFO) Then ICL670|Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy.
1243274|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243275|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243276|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243277|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243278|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243279|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243280|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243281|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243330|NCT00111813|O4|Outcome|Vorinostat 400 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
1243505|NCT00110617|O1|Outcome|Deferasirox (ICL670)|Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks.
1243659|NCT00110357|O7|Outcome|Group B: 250/20|Cetuximab 250 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
1243282|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243283|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243284|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243285|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243286|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243287|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243288|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243289|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243331|NCT00111813|O3|Outcome|Vorinostat 300 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
1243506|NCT00110617|O2|Outcome|Deferoxamine (DFO) Then ICL670|Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy.
1243290|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243291|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243292|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243293|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243294|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243295|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243296|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243297|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243332|NCT00111813|O2|Outcome|Vorinostat 200 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
1243507|NCT00110617|O1|Outcome|Deferasirox (ICL670)|Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks.
1243660|NCT00110357|O6|Outcome|Group B: 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in subjects 13-18 years of age
1243298|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243299|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243300|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243301|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
1243302|NCT00112047|E4|Reported Event|All Atripla (Week 144 to 240)|Exposure for all participants from both treatment groups who switched to ATR at Week 144 and continued treatment to Week 240 was up to 96 weeks. Exposure to ATR for 6 participants at sites in France was up to 144 weeks (this was due to a protocol amendment which allowed these participants to continue to receive ATR until it became commercially available). For this safety population, N=286.
1243303|NCT00112047|E3|Reported Event|CBV+EFV (Baseline to 144 Weeks)|Exposure to CBV+EFV during the randomized treatment phase was up to 144 weeks. For this safety population, N=254.
1243381|NCT00111657|O1|Outcome|Single Arm - Pegloticase|
1243305|NCT00112047|E1|Reported Event|FTC+TDF+EFV (Baseline to 144 Weeks)|Exposure to the component drugs EFV+FTC+TDF during the randomized treatment phase was up to 144 weeks (TVD replaced FTC+TDF from Week 96). For this safety population, N=257.
1243306|NCT00111917|B3|Baseline|Total|Total of all reporting groups
1243307|NCT00111917|B2|Baseline|Control|CBD placed on placebo
1243308|NCT00111917|B1|Baseline|Infliximab|patients who will be placed on infliximab and controls who will get placebo
1243309|NCT00111917|P2|Participant Flow|Group 2 - Placebo|This group was given a placebo infusion
1243310|NCT00111917|P1|Participant Flow|Group 1 - Infliximab|This group was given an infusion of inliximab
1243311|NCT00111917|O2|Outcome|Group 2|Placebo received
1243312|NCT00111917|O1|Outcome|Group 1|Infliximab
1243313|NCT00111917|O2|Outcome|Placebo|Placebo received
1243314|NCT00111917|O1|Outcome|Infliximab|Infliximab received
1243315|NCT00111917|O2|Outcome|Placebo|Placebo infusion
1243316|NCT00111917|O1|Outcome|Infliximab|Infliximab infusion
1243317|NCT00111917|O2|Outcome|Placebo|Placebo infusion
1243318|NCT00111917|O1|Outcome|Infliximab|Infliximab infusion
1243319|NCT00111917|E2|Reported Event|Group 2 - Placebo|Placebo infusion received
1243320|NCT00111917|E1|Reported Event|Group 1 - Infliximab|Infliximab infusion received
1243321|NCT00111813|B1|Baseline|All Participants|"Vorinostat capsules given 200 mg b.i.d., 300 mg q.d., or 400 mg q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib 0.7 mg/m^2, 0.9 mg/m^2, 1.1 mg/m^2, or 1.3 mg/m^2 twice weekly on Days 1, 4, 8, and 11 or on Days 4, 8, 11, and 15 of each cycle, depending on dose level."
1243322|NCT00111813|P6|Participant Flow|Vorinostat 400 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
1243323|NCT00111813|P5|Participant Flow|Vorinostat 400 mg + Bortezomib 1.1 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
1243744|NCT00110305|O2|Outcome|Efavirenz|Efavirenz 600 mg once daily
1243333|NCT00111813|O1|Outcome|Vorinostat 200 mg + Bortezomib 0.7 mg/m^2|"Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
1243334|NCT00111813|O6|Outcome|Vorinostat 400 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
1243335|NCT00111813|O5|Outcome|Vorinostat 400 mg + Bortezomib 1.1 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
1243336|NCT00111813|O4|Outcome|Vorinostat 400 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
1243337|NCT00111813|O3|Outcome|Vorinostat 300 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
1243338|NCT00111813|O2|Outcome|Vorinostat 200 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
1243339|NCT00111813|O1|Outcome|Vorinostat 200 mg + Bortezomib 0.7 mg/m^2|"Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
1243340|NCT00111813|O6|Outcome|Vorinostat 400 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
1243341|NCT00111813|O5|Outcome|Vorinostat 400 mg + Bortezomib 1.1 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
1243342|NCT00111813|O4|Outcome|Vorinostat 400 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
1243343|NCT00111813|O3|Outcome|Vorinostat 300 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
1243344|NCT00111813|O2|Outcome|Vorinostat 200 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
1243345|NCT00111813|O1|Outcome|Vorinostat 200 mg + Bortezomib 0.7 mg/m^2|"Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
1243374|NCT00111761|O1|Outcome|Panitumumab With FOLFIRI|Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
1243346|NCT00111813|O6|Outcome|Vorinostat 400 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
1243347|NCT00111813|O5|Outcome|Vorinostat 400 mg + Bortezomib 1.1 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
1243348|NCT00111813|O4|Outcome|Vorinostat 400 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
1243349|NCT00111813|O3|Outcome|Vorinostat 300 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
1243350|NCT00111813|O2|Outcome|Vorinostat 200 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
1243351|NCT00111813|O1|Outcome|Vorinostat 200 mg + Bortezomib 0.7 mg/m^2|"Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
1243352|NCT00111813|O1|Outcome|All Participants|"Vorinostat capsules given 200 mg b.i.d., 300 mg q.d., or 400 mg q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib 0.7 mg/m^2, 0.9 mg/m^2, 1.1 mg/m^2, or 1.3 mg/m^2 twice weekly on Days 1, 4, 8, and 11 or on Days 4, 8, 11, and 15 of each cycle, depending on dose level."
1243353|NCT00111813|E6|Reported Event|Vorinostat 400 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles~(participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
1243508|NCT00110617|O2|Outcome|Deferoxamine (DFO) Then ICL670|Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy.
1243354|NCT00111813|E5|Reported Event|Vorinostat 400 mg + Bortezomib 1.1 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles~(participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
1243355|NCT00111813|E4|Reported Event|Vorinostat 400 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles~(participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
1243356|NCT00111813|E3|Reported Event|Vorinostat 300 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
1243357|NCT00111813|E2|Reported Event|Vorinostat 200 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given b.i.d. Treatment in 21 day cycles~(participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
1243358|NCT00111813|E1|Reported Event|Vorinostat 200 mg + Bortezomib 0.7 mg/m^2|"Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
1243359|NCT00111761|B3|Baseline|Total|Total of all reporting groups
1243360|NCT00111761|B2|Baseline|Panitumumab With FOLFIRI|Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
1243361|NCT00111761|B1|Baseline|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
1243362|NCT00111761|P2|Participant Flow|Panitumumab With IFL|Panitumumab (2.5 mg/kg once weekly for up to 48 weeks or until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
1243363|NCT00111761|P1|Participant Flow|Panitumumab With FOLFIRI|Panitumumab (2.5 mg/kg once weekly until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
1243364|NCT00111761|O1|Outcome|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
1243365|NCT00111761|O1|Outcome|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
1243366|NCT00111761|O1|Outcome|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
1243367|NCT00111761|O1|Outcome|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
1243368|NCT00111761|O1|Outcome|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
1243369|NCT00111761|O1|Outcome|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
1243370|NCT00111761|O1|Outcome|Panitumumab With FOLFIRI|Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
1243371|NCT00111761|O1|Outcome|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
1243372|NCT00111761|O1|Outcome|Panitumumab With FOLFIRI|Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
1243373|NCT00111761|O1|Outcome|Panitumumab With FOLFIRI|Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
1243383|NCT00111657|O1|Outcome|Pegloticase|"All study participants received intravenous pegloticase at dose of 8 mg, administered every 21 days for a maximum of 5 doses.~There was no control group for this open label study.~Pegloticase: 8 mg of Pegloticase administered IV every 3 weeks; total number of infusions is 5"
1243384|NCT00111657|O1|Outcome|Pegloticase|"All study participants received intravenous pegloticase at dose of 8 mg, administered every 21 days for a maximum of 5 doses.~There was no control group for this open label study.~Pegloticase: 8 mg of Pegloticase administered IV every 3 weeks; total number of infusions is 5"
1243385|NCT00111657|O1|Outcome|Pegloticase|"All study participants received intravenous pegloticase at dose of 8 mg, administered every 21 days for a maximum of 5 doses.~There was no control group for this open label study.~Pegloticase: 8 mg of Pegloticase administered IV every 3 weeks; total number of infusions is 5"
1243386|NCT00111657|O1|Outcome|Pegloticase|"All study participants received intravenous pegloticase at dose of 8 mg, administered every 21 days for a maximum of 5 doses.~There was no control group for this open label study.~Pegloticase: 8 mg of Pegloticase administered IV every 3 weeks; total number of infusions is 5"
1243387|NCT00111657|O1|Outcome|Single Arm|
1243388|NCT00111657|E1|Reported Event|Single Arm - Pegloticase|
1243389|NCT00111007|B3|Baseline|Total|Total of all reporting groups
1243390|NCT00111007|B2|Baseline|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243509|NCT00110617|O1|Outcome|Deferasirox (ICL670)|Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks.
1243391|NCT00111007|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243392|NCT00111007|P2|Participant Flow|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243393|NCT00111007|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243394|NCT00111007|O2|Outcome|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243395|NCT00111007|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243396|NCT00111007|O2|Outcome|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243397|NCT00111007|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243398|NCT00111007|O2|Outcome|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243399|NCT00111007|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243400|NCT00111007|O2|Outcome|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243458|NCT00110812|O1|Outcome|IL-2|Consenting patients who were assigned IL-2 during the main phase of the study, including patients who took IL-2 alone as well as patients who took IL-2 with ART.
1243401|NCT00111007|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243402|NCT00111007|O2|Outcome|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243403|NCT00111007|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243404|NCT00111007|E2|Reported Event|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243510|NCT00110617|E4|Reported Event|Period 2 Deferoxamine (DFO) Then ICL670|Period 2 (After 24 weeks) DFO group cross over to Deferasirox (ICL670) orally 20 mg/kg completing 52 weeks on therapy and then entering an extension period.
1243405|NCT00111007|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243406|NCT00110994|B3|Baseline|Total|Total of all reporting groups
1243407|NCT00110994|B2|Baseline|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243408|NCT00110994|B1|Baseline|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243409|NCT00110994|P2|Participant Flow|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243410|NCT00110994|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243411|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243412|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243413|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243414|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243415|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243459|NCT00110812|O2|Outcome|Control|Consenting patients who were in the control group during the main phase of the trial.
1243416|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243417|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243418|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243419|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243420|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1256665|NCT00065429|P5|Participant Flow|IMGN 60 mg/m2|Arm 5, Phase 1 and 2
1243421|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243422|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243423|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243424|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243425|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243426|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243427|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243428|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243429|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243430|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243632|NCT00110357|O4|Outcome|Group A 250/16|Cetuximab 250 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
1243431|NCT00110994|E2|Reported Event|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243432|NCT00110994|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
1243433|NCT00110890|B3|Baseline|Total|Total of all reporting groups
1243434|NCT00110890|B2|Baseline|Standard of Care|Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator’s practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
1243435|NCT00110890|B1|Baseline|Cinacalcet|Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
1243436|NCT00110890|P2|Participant Flow|Standard of Care|Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator’s practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
1243437|NCT00110890|P1|Participant Flow|Cinacalcet|Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
1243438|NCT00110890|O2|Outcome|Standard of Care|Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator’s practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
1243440|NCT00110890|O2|Outcome|Standard of Care|Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator’s practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
1243441|NCT00110890|O1|Outcome|Cinacalcet|Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
1243442|NCT00110890|O2|Outcome|Standard of Care|Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator’s practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
1243443|NCT00110890|O1|Outcome|Cinacalcet|Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
1243444|NCT00110890|O2|Outcome|Standard of Care|Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator’s practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
1243445|NCT00110890|O1|Outcome|Cinacalcet|Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
1243446|NCT00110890|O2|Outcome|Standard of Care|Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator’s practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
1243447|NCT00110890|O1|Outcome|Cinacalcet|Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
1243448|NCT00110890|E2|Reported Event|Cinacalcet|
1243449|NCT00110890|E1|Reported Event|Standard Care|
1243450|NCT00110812|B4|Baseline|Total|Total of all reporting groups
1243451|NCT00110812|B3|Baseline|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
1243452|NCT00110812|B2|Baseline|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
1243453|NCT00110812|B1|Baseline|No IL-2|Participants will receive no aldesleukin or HAART
1243454|NCT00110812|P3|Participant Flow|IL-2 With Pericycle HAART|During the main study, participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle). Patients did not receive aldesleukin during the extension phase.
1243455|NCT00110812|P2|Participant Flow|IL-2 Without ART|During the main study, participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level. Patients did not receive aldesleukin during the extension phase.
1243456|NCT00110812|P1|Participant Flow|No IL-2|Participants will receive no aldesleukin or HAART during the main study or extension
1243457|NCT00110812|O2|Outcome|Control|Consenting patients who were in the control group during the main phase of the trial.
1243716|NCT00110305|P2|Participant Flow|Efavirenz|Efavirenz 600 mg once daily
1243460|NCT00110812|O1|Outcome|IL-2|Consenting patients who were assigned IL-2 during the main phase of the study, including patients who took IL-2 alone as well as patients who took IL-2 with ART.
1243461|NCT00110812|O2|Outcome|Control|Consenting patients who were in the control group during the main phase of the trial.
1243462|NCT00110812|O1|Outcome|IL-2|Consenting patients who were assigned IL-2 during the main phase of the study, including patients who took IL-2 alone as well as patients who took IL-2 with ART.
1243463|NCT00110812|O2|Outcome|Control|Consenting patients who were in the control group during the main phase of the trial.
1243464|NCT00110812|O1|Outcome|IL-2|Consenting patients who were assigned IL-2 during the main phase of the study, including patients who took IL-2 alone as well as patients who took IL-2 with ART.
1243465|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
1243466|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
1243467|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
1243468|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
1243511|NCT00110617|E3|Reported Event|Period 2 Deferasirox (ICL670)|Period 2 (after 24 weeks) Deferasirox (ICL670) 20 mg/kg orally once daily.
1243471|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
1243472|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
1243473|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
1243474|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
1243475|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
1243476|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
1243477|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
1243478|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
1243479|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
1243480|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
1243481|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
1243482|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
1243483|NCT00110812|O1|Outcome|IL-2 With Pericycle HAART|
1243484|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
1243485|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
1243486|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
1243487|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
1243488|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
1243489|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
1243490|NCT00110812|O2|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
1243491|NCT00110812|O1|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
1243492|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
1243493|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
1243494|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
1243495|NCT00110812|E3|Reported Event|No IL-2|
1243496|NCT00110812|E2|Reported Event|IL-2 Without ART|
1243497|NCT00110812|E1|Reported Event|IL-2 With Pericylce HAART|
1243498|NCT00110617|B3|Baseline|Total|Total of all reporting groups
1243499|NCT00110617|B2|Baseline|Deferoxamine (DFO) Then ICL670|Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy.
1243500|NCT00110617|B1|Baseline|Deferasirox (ICL670)|Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks.
1243512|NCT00110617|E2|Reported Event|Period 1 Deferoxamine (DFO)|Period 1 (first 24 weeks) Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg.
1243514|NCT00110513|B1|Baseline|Recombinant Human Antithrombin (rhAT) Infusion|Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient received an initial intravenous loading dose of recombinant human antithrombin (rhAT)followed by a continuous intravenous infusion dose of recombinant human antithrombin (rhAT) to maintain an antithrombin (AT) activity level of >80% and <120% of normal.
1243515|NCT00110513|P1|Participant Flow|Recombinant Human Antithrombin (rhAT) Infusion|Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient received an initial intravenous loading dose of recombinant human antithrombin (rhAT)followed by a continuous intravenous infusion dose of recombinant human antithrombin (rhAT) to maintain an antithrombin (AT) activity level of >80% and <120% of normal.
1243516|NCT00110513|O1|Outcome|Recombinant Human Antithrombin (rhAT) Infusion|Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient received an initial intravenous loading dose of recombinant human antithrombin (rhAT)followed by a continuous intravenous infusion dose of recombinant human antithrombin (rhAT) to maintain an antithrombin (AT) activity level >80% and <120% of normal.
1243517|NCT00110513|E1|Reported Event|Recombinant Human Antithrombin (rhAT) Infusion|Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient received an initial intravenous loading dose of recombinant human antithrombin (rhAT)followed by a continuous intravenous infusion dose of recombinant human antithrombin (rhAT) to maintain an antithrombin (AT) activity level of >80% and <120% of normal.
1243518|NCT00110461|B4|Baseline|Total|Total of all reporting groups
1243519|NCT00110461|B3|Baseline|Placebo|Participants were given a single pill administered once daily.
1243520|NCT00110461|B2|Baseline|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
1243521|NCT00110461|B1|Baseline|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
1243522|NCT00110461|P3|Participant Flow|Placebo|Participants were given a single pill administered once daily.
1243523|NCT00110461|P2|Participant Flow|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
1243524|NCT00110461|P1|Participant Flow|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
1243525|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
1243526|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
1243527|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
1243528|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
1243633|NCT00110357|O3|Outcome|Group A 150/20|Cetuximab 150 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
1243634|NCT00110357|O2|Outcome|Group A 150/16|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years of age
1243635|NCT00110357|O1|Outcome|Group A 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years
1243529|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
1243530|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
1243531|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
1243532|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
1243533|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
1243534|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
1243535|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
1243536|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
1243537|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
1243661|NCT00110357|O5|Outcome|Group B: 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
1243538|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
1243539|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
1243540|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
1243541|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
1243542|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
1243543|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
1243544|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
1243545|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
1243546|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
1243547|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
1243548|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
1243549|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
1243550|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
1243551|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
1243552|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
1243636|NCT00110357|O7|Outcome|Group B 250/20|Cetuximab 250 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
1243637|NCT00110357|O6|Outcome|Group B 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in subjects 13-18 years of age
1243553|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
1243554|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
1243555|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
1243556|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
1243557|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
1243558|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
1243559|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
1243560|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
1243561|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
1243662|NCT00110357|O4|Outcome|Group A: 250/16|Cetuximab 250 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
1243663|NCT00110357|O3|Outcome|Group A 150/16|Cetuximab 150 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
1243664|NCT00110357|O2|Outcome|Group A: 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years of age
1243562|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
1243563|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
1243564|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
1243565|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
1243566|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
1243567|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
1243568|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
1243569|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
1243570|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
1243571|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
1243572|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
1243573|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
1243574|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
1243575|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
1243576|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
1243577|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
1243578|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
1243579|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
1243580|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
1243581|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
1243582|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
1243583|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
1243584|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
1243585|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
1243665|NCT00110357|O1|Outcome|Group A: 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years
1243666|NCT00110357|O1|Outcome|Number of Participants|
1243667|NCT00110357|O2|Outcome|Non-CNS Primary Tumor|
1243668|NCT00110357|O1|Outcome|CNS Primary Tumor|
1243586|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
1243587|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
1243588|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
1243589|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
1243590|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
1243591|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
1243592|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
1243593|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
1243594|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
1243595|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
1243596|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
1243597|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
1243598|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
1243599|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
1243600|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
1243601|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
1243602|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
1243603|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
1243604|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
1243605|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
1243606|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
1243607|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
1243608|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
1243609|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
1243669|NCT00110357|O6|Outcome|Group B: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
1243670|NCT00110357|O5|Outcome|Group B: 150|Cetuximab 150 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
1243671|NCT00110357|O4|Outcome|Group B: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
1243610|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
1243611|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
1243612|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
1243613|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
1243614|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
1243615|NCT00110461|E3|Reported Event|Placebo|Participants were given a single pill administered once daily.
1243616|NCT00110461|E2|Reported Event|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
1243617|NCT00110461|E1|Reported Event|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
1243618|NCT00110396|B1|Baseline|Rebif New Formulation (RNF) Cohort|Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
1243619|NCT00110396|P1|Participant Flow|Rebif New Formulation (RNF) Cohort|Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
1243620|NCT00110396|O1|Outcome|Rebif New Formulation (RNF) Cohort|Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
1243621|NCT00110396|O1|Outcome|Rebif New Formulation (RNF) Cohort|Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
1243622|NCT00110396|O1|Outcome|Rebif New Formulation (RNF) Cohort|Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
1243623|NCT00110396|E1|Reported Event|Rebif New Formulation (RNF) Cohort|Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
1243624|NCT00110357|B3|Baseline|Total|Total of all reporting groups
1243625|NCT00110357|B2|Baseline|13- to 18-years-old|
1243626|NCT00110357|B1|Baseline|1- to 12-years-old|
1243627|NCT00110357|P2|Participant Flow|13- to 18-years-old|
1243628|NCT00110357|P1|Participant Flow|1- to 12-years-old|
1243629|NCT00110357|O7|Outcome|Group B 250/20|Cetuximab 250 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
1243630|NCT00110357|O6|Outcome|Group B 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in subjects 13-18 years of age
1243631|NCT00110357|O5|Outcome|Group B 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
1243638|NCT00110357|O5|Outcome|Group B 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
1243639|NCT00110357|O4|Outcome|Group A 250/16|Cetuximab 250 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
1243640|NCT00110357|O3|Outcome|Group A 150/20|Cetuximab 150 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
1243641|NCT00110357|O2|Outcome|Group A 150/16|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years of age
1243642|NCT00110357|O1|Outcome|Group A 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years
1243643|NCT00110357|O7|Outcome|Group B 250/20|Cetuximab 250 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
1243644|NCT00110357|O6|Outcome|Group B 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in subjects 13-18 years of age
1243645|NCT00110357|O5|Outcome|Group B 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
1243646|NCT00110357|O4|Outcome|Group A 250/16|Cetuximab 250 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
1243647|NCT00110357|O3|Outcome|Group A 150/20|Cetuximab 150 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
1243648|NCT00110357|O2|Outcome|Group A 150/16|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years of age
1243649|NCT00110357|O1|Outcome|Group A 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years
1243650|NCT00110357|O7|Outcome|Group B 250/20|Cetuximab 250 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
1243651|NCT00110357|O6|Outcome|Group B 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in subjects 13-18 years of age
1243652|NCT00110357|O5|Outcome|Group B 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
1243653|NCT00110357|O4|Outcome|Group A 250/16|Cetuximab 250 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
1243737|NCT00110305|O2|Outcome|TMC278 75 mg|TMC278 75 mg once daily
1243672|NCT00110357|O3|Outcome|Group A: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years of age
1243673|NCT00110357|O2|Outcome|Group A: 150|Cetuximab 150 mg/m2 + 16-20 mg/m2 in participants 1-12 years of age
1243674|NCT00110357|O1|Outcome|Group A: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years
1243675|NCT00110357|O6|Outcome|Group B: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
1243676|NCT00110357|O5|Outcome|Group B: 150|Cetuximab 150 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
1243677|NCT00110357|O4|Outcome|Group B: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
1243678|NCT00110357|O3|Outcome|Group A: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years of age
1243679|NCT00110357|O2|Outcome|Group A :150|Cetuximab 150 mg/m2 + 16-20 mg/m2 in participants 1-12 years of age
1243680|NCT00110357|O1|Outcome|Group A: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years
1243681|NCT00110357|O6|Outcome|Group B: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
1243682|NCT00110357|O5|Outcome|Group B: 150|Cetuximab 150 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
1243683|NCT00110357|O4|Outcome|Group B: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
1243684|NCT00110357|O3|Outcome|Group A: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years of age
1243685|NCT00110357|O2|Outcome|Group A :150|Cetuximab 150 mg/m2 + 16-20 mg/m2 in participants 1-12 years of age
1243686|NCT00110357|O1|Outcome|Group A: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years
1243687|NCT00110357|O6|Outcome|Group B: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
1243688|NCT00110357|O5|Outcome|Group B: 150|Cetuximab 150 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
1243689|NCT00110357|O4|Outcome|Group B: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
1243690|NCT00110357|O3|Outcome|Group A: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years of age
1243691|NCT00110357|O2|Outcome|Group A :150|Cetuximab 150 mg/m2 + 16-20 mg/m2 in participants 1-12 years of age
1243692|NCT00110357|O1|Outcome|Group A: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years
1243693|NCT00110357|O6|Outcome|Group B: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
1243694|NCT00110357|O5|Outcome|Group B: 150|Cetuximab 150 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
1243695|NCT00110357|O4|Outcome|Group B: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
1243696|NCT00110357|O3|Outcome|Group A: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years of age
1243697|NCT00110357|O2|Outcome|Group A :150|Cetuximab 150 mg/m2 + 16-20 mg/m2 in participants 1-12 years of age
1243698|NCT00110357|O1|Outcome|Group A: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years
1243699|NCT00110357|O7|Outcome|Group B: 250/20|Cetuximab 250 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
1243700|NCT00110357|O6|Outcome|Group B: 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in subjects 13-18 years of age
1243701|NCT00110357|O5|Outcome|Group B: 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
1243702|NCT00110357|O4|Outcome|Group A: 250/16|Cetuximab 250 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
1243703|NCT00110357|O3|Outcome|Group A 150/16|Cetuximab 150 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
1243704|NCT00110357|O2|Outcome|Group A: 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years of age
1243705|NCT00110357|O1|Outcome|Group A: 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years
1243706|NCT00110357|E5|Reported Event|05 250 mg/m2 CET + 20 mg/m2 IRI|
1243707|NCT00110357|E4|Reported Event|04 250 mg/m2 CET + 16 mg/m2 IRI|
1243708|NCT00110357|E3|Reported Event|03 150 mg/m2 CET + 16 mg/m2 IRI|
1243709|NCT00110357|E2|Reported Event|02 150 mg/m2 CET + 20 mg/m2 IRI|
1243710|NCT00110357|E1|Reported Event|01 75 mg/m2 CET + 20 mg/m2 IRI|
1243711|NCT00110305|B5|Baseline|Total|Total of all reporting groups
1243712|NCT00110305|B4|Baseline|Efavirenz|Efavirenz 600 mg once daily
1243717|NCT00110305|P1|Participant Flow|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
1243718|NCT00110305|O4|Outcome|AUC24h Quartile 4|TMC278 25 mg, 75 mg, and 150 mg once daily
1243719|NCT00110305|O3|Outcome|AUC24h Quartile 3|TMC278 25 mg, 75 mg, and 150 mg once daily
1243720|NCT00110305|O2|Outcome|AUC24h Quartile 2|TMC278 25 mg, 75 mg, and 150 mg once daily
1243721|NCT00110305|O1|Outcome|AUC24h Quartile 1|TMC278 25 mg, 75 mg, and 150 mg once daily
1243722|NCT00110305|O3|Outcome|TMC278 150 mg|TMC278 150 mg once daily
1243723|NCT00110305|O2|Outcome|TMC278 75 mg|TMC278 75 mg once daily
1243724|NCT00110305|O1|Outcome|TMC278 25 mg|TMC278 25 mg once daily
1243725|NCT00110305|O3|Outcome|TMC278 150 mg|TMC278 150 mg once daily
1243726|NCT00110305|O2|Outcome|TMC278 75 mg|TMC278 75 mg once daily
1243727|NCT00110305|O1|Outcome|TMC278 25 mg|TMC278 25 mg once daily
1243728|NCT00110305|O2|Outcome|Efavirenz|Efavirenz 600 mg once daily
1243729|NCT00110305|O1|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
1243730|NCT00110305|O2|Outcome|Efavirenz|Efavirenz 600 mg once daily
1243731|NCT00110305|O1|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
1243732|NCT00110305|O2|Outcome|Efavirenz|Efavirenz 600 mg once daily
1243733|NCT00110305|O1|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
1243734|NCT00110305|O5|Outcome|Efavirenz|Efavirenz 600 mg once daily
1243735|NCT00110305|O4|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
1243736|NCT00110305|O3|Outcome|TMC278 150 mg|TMC278 150 mg once daily
1243745|NCT00110305|O1|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
1243746|NCT00110305|O2|Outcome|Efavirenz|Efavirenz 600 mg once daily
1243747|NCT00110305|O1|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
1243748|NCT00110305|O2|Outcome|Efavirenz|Efavirenz 600 mg once daily
1243749|NCT00110305|O1|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
1243750|NCT00110305|O5|Outcome|Efavirenz|Efavirenz 600 mg once daily
1243751|NCT00110305|O4|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
1243752|NCT00110305|O3|Outcome|TMC278 150 mg|TMC278 150 mg once daily
1243753|NCT00110305|O2|Outcome|TMC278 75 mg|TMC278 75 mg once daily
1243754|NCT00110305|O1|Outcome|TMC278 25 mg|TMC278 25 mg once daily
1243755|NCT00110305|O5|Outcome|Efavirenz|Efavirenz 600 mg once daily
1243756|NCT00110305|O4|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
1243757|NCT00110305|O3|Outcome|TMC278 150 mg|TMC278 150 mg once daily
1243758|NCT00110305|O2|Outcome|TMC278 75 mg|TMC278 75 mg once daily
1243759|NCT00110305|O1|Outcome|TMC278 25 mg|TMC278 25 mg once daily
1243760|NCT00110305|O5|Outcome|Efavirenz|Efaviren 600 mg once daily
1243761|NCT00110305|O4|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
1243762|NCT00110305|O3|Outcome|TMC278 150 mg|TMC278 150 mg once daily
1243763|NCT00110305|O2|Outcome|TMC278 75 mg|TMC278 75 mg once daily
1243764|NCT00110305|O1|Outcome|TMC278 25 mg|TMC278 25 mg once daily
1243765|NCT00110305|E2|Reported Event|Efavirenz|Efavirenz 600 mg once daily
1243766|NCT00110305|E1|Reported Event|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
1243767|NCT00110214|B3|Baseline|Total|Total of all reporting groups
1243768|NCT00110214|B2|Baseline|Docetaxel + Bevacizumab|Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
1243769|NCT00110214|B1|Baseline|Docetaxel + Placebo|Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
1243770|NCT00110214|P2|Participant Flow|Docetaxel + Bevacizumab|Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
1243771|NCT00110214|P1|Participant Flow|Docetaxel + Placebo|Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
1243772|NCT00110214|O2|Outcome|Docetaxel + Bevacizumab|Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
1243773|NCT00110214|O1|Outcome|Docetaxel + Placebo|Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
1243774|NCT00110214|O2|Outcome|Docetaxel + Bevacizumab|Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
1243775|NCT00110214|O1|Outcome|Docetaxel + Placebo|Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
1243776|NCT00110214|O2|Outcome|Docetaxel + Bevacizumab|Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
1243777|NCT00110214|O1|Outcome|Docetaxel + Placebo|Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
1243778|NCT00110214|O2|Outcome|Docetaxel + Bevacizumab|Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
1243779|NCT00110214|O1|Outcome|Docetaxel + Placebo|Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
1243780|NCT00110214|E2|Reported Event|Docetaxel + Bevacizumab|Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
1243781|NCT00110214|E1|Reported Event|Docetaxel + Placebo|Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
1243782|NCT00110136|B1|Baseline|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day~St. John's Wort: St. John's Wort 300mg tablet three times per day"
1243783|NCT00110136|P1|Participant Flow|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day~St. John's Wort: St. John's Wort 300mg tablet three times per day"
1255934|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
1243784|NCT00110136|O1|Outcome|St. John's Wort|"Patients given one 300mg St. John's Wort tablet three times per day~St. John's Wort: St. John's Wort 300mg tablet three times per day"
1243785|NCT00110136|O1|Outcome|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day~St. John's Wort: St. John's Wort 300mg tablet three times per day"
1243786|NCT00110136|O1|Outcome|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day~St. John's Wort: St. John's Wort 300mg tablet three times per day"
1243787|NCT00110136|O1|Outcome|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day~St. John's Wort: St. John's Wort 300mg tablet three times per day"
1243788|NCT00110136|O1|Outcome|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day~St. John's Wort: St. John's Wort 300mg tablet three times per day"
1243789|NCT00110136|O1|Outcome|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day~St. John's Wort: St. John's Wort 300mg tablet three times per day"
1243790|NCT00110136|E1|Reported Event|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day~St. John's Wort: St. John's Wort 300mg tablet three times per day"
1243791|NCT00110084|B1|Baseline|Nab-paclitaxel/Gemcitabine|Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
1243792|NCT00110084|P1|Participant Flow|Nab-paclitaxel/Gemcitabine|Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
1243980|NCT00109473|O1|Outcome|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
1243793|NCT00110084|O1|Outcome|Nab-paclitaxel/Gemcitabine|Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
1243794|NCT00110084|O1|Outcome|Nab-paclitaxel/Gemcitabine|Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
1243795|NCT00110084|O1|Outcome|Nab-paclitaxel/Gemcitabine|Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
1243796|NCT00110084|O1|Outcome|Nab-paclitaxel/Gemcitabine|Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
1243797|NCT00110084|E1|Reported Event|Nab-paclitaxel/Gemcitabine|Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
1243798|NCT00110019|B3|Baseline|Total|Total of all reporting groups
1243799|NCT00110019|B2|Baseline|Arm II (Carboplatin+Paclitaxel)|Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
1243800|NCT00110019|B1|Baseline|Arm I (Carboplatin+Paclitaxel+Sorafenib)|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
1243801|NCT00110019|P2|Participant Flow|Arm II (Carboplatin+Paclitaxel)|Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
1243802|NCT00110019|P1|Participant Flow|Arm I (Carboplatin+Paclitaxel+Sorafenib)|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
1243803|NCT00110019|O2|Outcome|Arm II (Carboplatin + Paclitaxel+Placebo)|Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
1243804|NCT00110019|O1|Outcome|Arm I (Carboplatin + Paclitaxel + Sorafenib)|Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
1243805|NCT00110019|O2|Outcome|Arm II (Carboplatin + Paclitaxel+Placebo)|Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
1243806|NCT00110019|O1|Outcome|Arm I (Carboplatin + Paclitaxel + Sorafenib)|Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
1243807|NCT00110019|O2|Outcome|Arm II (Carboplatin + Paclitaxel+Placebo)|Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
1243808|NCT00110019|O1|Outcome|Arm I (Carboplatin + Paclitaxel + Sorafenib)|Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
1243809|NCT00110019|E2|Reported Event|Arm II (Carboplatin + Paclitaxel+Placebo)|Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
1243810|NCT00110019|E1|Reported Event|Arm I (Carboplatin + Paclitaxel + Sorafenib)|Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
1243811|NCT00109967|B3|Baseline|Total|Total of all reporting groups
1243812|NCT00109967|B2|Baseline|Group II: Rituximab Refractory|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV temsirolimus: 25 mg given IV"
1243843|NCT00109876|O1|Outcome|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
1243960|NCT00109590|E3|Reported Event|Mother: LPV/r x 30d|ZDV, ddI, LPV/r x 30d
1243961|NCT00109590|E2|Reported Event|Mother: no LPV/r|ZDV & ddI x 30d
1243813|NCT00109967|B1|Baseline|Group I: Rituximab Sensitive|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV temsirolimus: 25 mg given IV"
1243814|NCT00109967|P2|Participant Flow|Group II: Rituximab Refractory|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
1243815|NCT00109967|P1|Participant Flow|Group I: Rituximab Sensitive|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
1243816|NCT00109967|O2|Outcome|Group II: Rituximab Refractory|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
1243817|NCT00109967|O1|Outcome|Group I: Rituximab Sensitive|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
1243818|NCT00109967|O2|Outcome|Group II: Rituximab Refractory|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
1243819|NCT00109967|O1|Outcome|Group I: Rituximab Sensitive|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
1243820|NCT00109967|O2|Outcome|Group II: Rituximab Refractory|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
1243821|NCT00109967|O1|Outcome|Group I: Rituximab Sensitive|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
1243822|NCT00109967|O2|Outcome|Group II: Rituximab Refractory|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
1243823|NCT00109967|O1|Outcome|Group I: Rituximab Sensitive|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
1243824|NCT00109967|O2|Outcome|Group II: Rituximab Refractory|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
1256666|NCT00065429|P4|Participant Flow|IMGN 40 mg/m2|Arm 4, Phase 1
1243825|NCT00109967|O1|Outcome|Group I: Rituximab Sensitive|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
1243826|NCT00109967|E2|Reported Event|Group II: Rituximab Refractory|temsirolimus: 25 mg given IV
1243827|NCT00109967|E1|Reported Event|Group I: Rituximab Sensitive|temsirolimus: 25 mg given IV
1243828|NCT00109928|B1|Baseline|PEGS|Patients received IV cisplatin 25 mg/m2 days 1–4, etoposide 40 mg/m2 days 1–4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1–4 of a 21 day cycle for 6 cycles.
1243829|NCT00109928|P1|Participant Flow|PEGS|Patients received IV cisplatin 25 mg/m2 days 1–4, etoposide 40 mg/m2 days 1–4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1–4 of a 21 day cycle for 6 cycles.
1243830|NCT00109928|O1|Outcome|PEGS|Patients received IV cisplatin 25 mg/m2 days 1 to 4, etoposide 40 mg/m2 days 1 to 4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1 to 4 of a 21 day cycle for 6 cycles.)
1243831|NCT00109928|O1|Outcome|PEGS|Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.
1243832|NCT00109928|O1|Outcome|PEGS|Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.
1243833|NCT00109928|O1|Outcome|PEGS|Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.
1243834|NCT00109928|E1|Reported Event|PEGS|Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.)
1243835|NCT00109876|B1|Baseline|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
1243836|NCT00109876|P1|Participant Flow|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
1243837|NCT00109876|O1|Outcome|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
1243838|NCT00109876|O1|Outcome|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
1243839|NCT00109876|O1|Outcome|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
1243840|NCT00109876|O1|Outcome|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
1243841|NCT00109876|O1|Outcome|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
1243842|NCT00109876|O1|Outcome|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
1243844|NCT00109876|E1|Reported Event|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
1243845|NCT00109850|B1|Baseline|Treatment|Cetuximab+Cisplatin+Irinotecan followed by radiation therapy (RT) in Cycle 3
1243846|NCT00109850|P1|Participant Flow|Treatment|Cetuximab+Cisplatin+Irinotecan followed by radiation therapy (RT) in Cycle 3
1243847|NCT00109850|O1|Outcome|Cetuximab+Cisplatin+Irinotecan Followed by Radiation Therapy|Patients received four 21-day cycles of cetuximab 400 mg/m^2 (day 1, cycle 1), cetuximab 250 mg/m^2 (day 8, 15, cycle 1, then days 1, 8 and 15 for subsequent cycles), cisplatin 30 mg/m^2 (days 1 and 8, all cycles), and irinotecan 65 mg/m^2 (days 1 and 8, all cycles). Thoracic Radiotherapy (TRT) was administered at 1.8 Gy in 28 daily fractions to a total dose of 50.4 Gy, beginning on day 1 of cycle 3.
1243848|NCT00109850|O1|Outcome|Cetuximab+Cisplatin+Irinotecan Followed by Radiation Therapy|Patients received four 21-day cycles of cetuximab 400 mg/m^2 (day 1, cycle 1), cetuximab 250 mg/m^2 (day 8, 15, cycle 1, then days 1, 8 and 15 for subsequent cycles), cisplatin 30 mg/m^2 (days 1 and 8, all cycles), and irinotecan 65 mg/m^2 (days 1 and 8, all cycles). Thoracic Radiotherapy (TRT) was administered at 1.8 Gy in 28 daily fractions to a total dose of 50.4 Gy, beginning on day 1 of cycle 3.
1243849|NCT00109850|O1|Outcome|Cetuximab+Cisplatin+Irinotecan Followed by Radiation Therapy|Patients received four 21-day cycles of cetuximab 400 mg/m^2 (day 1, cycle 1), cetuximab 250 mg/m^2 (day 8, 15, cycle 1, then days 1, 8 and 15 for subsequent cycles), cisplatin 30 mg/m^2 (days 1 and 8, all cycles), and irinotecan 65 mg/m^2 (days 1 and 8, all cycles). Thoracic Radiotherapy (TRT) was administered at 1.8 Gy in 28 daily fractions to a total dose of 50.4 Gy, beginning on day 1 of cycle 3.
1243981|NCT00109473|O2|Outcome|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
1243982|NCT00109473|O1|Outcome|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
1243850|NCT00109850|O1|Outcome|Cetuximab+Cisplatin+Irinotecan Followed by Radiation Therapy|Patients received four 21-day cycles of cetuximab 400 mg/m^2 (day 1, cycle 1), cetuximab 250 mg/m^2 (day 8, 15, cycle 1, then days 1, 8 and 15 for subsequent cycles), cisplatin 30 mg/m^2 (days 1 and 8, all cycles), and irinotecan 65 mg/m^2 (days 1 and 8, all cycles). Thoracic Radiotherapy (TRT) was administered at 1.8 Gy in 28 daily fractions to a total dose of 50.4 Gy, beginning on day 1 of cycle 3.
1243851|NCT00109850|E1|Reported Event|Cetuximab+Cisplatin+Irinotecan Followed by RT in Cycle 3|Patients received four 21-day cycles of cetuximab 400 mg/m^2 (day 1, cycle 1), cetuximab 250 mg/m^2 (day 8, 15, cycle 1, then days 1, 8 and 15 for subsequent cycles), cisplatin 30 mg/m^2 (days 1 and 8, all cycles), and irinotecan 65 mg/m^2 (days 1 and 8, all cycles). Thoracic Radiotherapy (TRT) was administered at 1.8 Gy in 28 daily fractions to a total dose of 50.4 Gy, beginning on day 1 of cycle 3.
1243852|NCT00109837|B1|Baseline|Treatment|"Treatment included:~Induc 1: Allo; Dauno; Vin; Pred; asparag; Bactrim Induc 2: Allo; AraC; Dex; GCSF; Mitx; Meth; leuc; Meth Consol: cyclo; AraC; 6-mercapto; Meth; GCSF Maint:Course 1: 6-mercapto; Meth 20 Course 2: Vincristine; Adriamycin; Dex Course 3: Cyclo; 6-thio; AraC Course 4: 6-mercapto; meth"
1243853|NCT00109837|P1|Participant Flow|Treatment|"Treatment included:~Induc 1: Allo; Dauno; Vin; Pred; asparag; Bactrim Induc 2: Allo; AraC; Dex; GCSF; Mitx; Meth; leuc; Meth Consol: cyclo; AraC; 6-mercapto; Meth; GCSF Maint:Course 1: 6-mercapto; Meth 20 Course 2: Vincristine; Adriamycin; Dex Course 3: Cyclo; 6-thio; AraC Course 4: 6-mercapto; meth"
1243854|NCT00109837|O1|Outcome|Induction|One induction cycle with allopurinol, daunorubicin, vincristine, prednisone, amd PEG- L-asparaginase.
1243855|NCT00109837|O1|Outcome|Treatment|Treatment included: Induc 1: Allo; Dauno; Vin; Pred; asparag; Bactrim Induc 2: Allo; AraC; Dex; GCSF; Mitx; Meth; leuc; Meth Consol: cyclo; AraC; 6-mercapto; Meth; GCSF Maint:Course 1: 6-mercapto; Meth 20 Course 2: Vincristine; Adriamycin; Dex Course 3: Cyclo; 6-thio; AraC Course 4: 6-mercapto; meth
1243856|NCT00109837|E4|Reported Event|Maintenance|Patient with a CR after consolidation could receive up to four courses of maintenance. Course 1 included 6-mercaptopurine and methotrexate. course 2 included vincristine, adriamycin, and dexamethasone. course 3 included cyclophosphamide, 6-thioguanine, and ara-C. course 4 included 6-mercaptopurine and methotrexate
1243857|NCT00109837|E3|Reported Event|Consolidation|Patients who had a CR after induction could receive one course of consolidation therapy consisting of cyclophosphamide, ara-C, 6-mercaptopurine, G-CSF and methotrexate
1243858|NCT00109837|E2|Reported Event|Second Induction|A second induction cycle with allopurinol , dexamergasone, G-CSF, high-dose ara-C and mitoxantrone
1243859|NCT00109837|E1|Reported Event|First Induction|One induction cycle with allopurinol, daunorubicin, vincristine, prednisone, amd PEG- L-asparaginase.
1243860|NCT00109772|B3|Baseline|Total|Total of all reporting groups
1243861|NCT00109772|B2|Baseline|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243862|NCT00109772|B1|Baseline|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243863|NCT00109772|P2|Participant Flow|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243864|NCT00109772|P1|Participant Flow|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243865|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243913|NCT00109733|O1|Outcome|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
1256732|NCT00064844|E1|Reported Event|Nicotine Patch Plus Active Gum|
1243866|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243867|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243868|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243869|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243870|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243871|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243872|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243983|NCT00109473|O2|Outcome|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
1256667|NCT00065429|P3|Participant Flow|IMGN 20 mg/m2|Arm 3, Phase 1
1243873|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243874|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243875|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243876|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243877|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243878|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243879|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243880|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243881|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243882|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243883|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243884|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243885|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243886|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243959|NCT00109590|E4|Reported Event|Infant: LPV/r x 7d|NVP 200 mg orally, single dose at onset
1243887|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243888|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243889|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243890|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243891|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243892|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243893|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243894|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243895|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243896|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243897|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243898|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243899|NCT00109772|E2|Reported Event|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243900|NCT00109772|E1|Reported Event|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
1243901|NCT00109733|B3|Baseline|Total|Total of all reporting groups
1243902|NCT00109733|B2|Baseline|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
1243903|NCT00109733|B1|Baseline|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
1243904|NCT00109733|P2|Participant Flow|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
1243905|NCT00109733|P1|Participant Flow|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
1243906|NCT00109733|O2|Outcome|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
1243907|NCT00109733|O1|Outcome|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
1243908|NCT00109733|O2|Outcome|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
1243909|NCT00109733|O1|Outcome|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
1243910|NCT00109733|O2|Outcome|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
1243911|NCT00109733|O1|Outcome|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
1243912|NCT00109733|O2|Outcome|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
1243914|NCT00109733|O2|Outcome|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
1243915|NCT00109733|O1|Outcome|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
1243916|NCT00109733|E2|Reported Event|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
1243917|NCT00109733|E1|Reported Event|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
1243918|NCT00109590|B4|Baseline|Total|Total of all reporting groups
1243919|NCT00109590|B3|Baseline|Arm C: LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
1243920|NCT00109590|B2|Baseline|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
1243921|NCT00109590|B1|Baseline|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
1243984|NCT00109473|O1|Outcome|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
1243922|NCT00109590|P3|Participant Flow|Arm C: LPV/r x 30d|Nevirapine (NVP) 200 mg orally, single dose at onset of labor, Zidovudine (ZDV) 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, didanosine (ddI) 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, Lopinavir/Ritonavir (LPV/r) 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
1243923|NCT00109590|P2|Participant Flow|Arm B : no LPV/r|Neviarpine (NVP) 200 mg orally, single dose at onset of labor, Zidovudine (ZDV) 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, didanosine (ddI) 250 mg orally (if body weight <60 kg) or 400 mg orally once daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
1243924|NCT00109590|P1|Participant Flow|Arm A : LPV/r x 7d|Nevirapine (NVP) 200 mg orally, single dose at onset of labor, Zidovudine (ZDV) 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, didanosine (ddI) 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, > Lopinavir/Ritonavir (LPV/r) 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
1243925|NCT00109590|O2|Outcome|At Day 30 Ppm|ZDV, ddI, LPV/r x 30d
1243926|NCT00109590|O1|Outcome|Within 72 Hrs Ppm|ZDV, ddI, LPV/r x 30d
1243927|NCT00109590|O2|Outcome|At Day 30 Ppm|ZDV, ddI, LPV/r x 30d
1243928|NCT00109590|O1|Outcome|Within 72 Hrs Ppm|ZDV, ddI, LPV/r x 30d
1243929|NCT00109590|O2|Outcome|At Day 30 Ppm|ZDV, ddI, LPV/r x 30d
1243930|NCT00109590|O1|Outcome|Within 72 Hrs Ppm|ZDV, ddI, LPV/r x 30d
1243931|NCT00109590|O3|Outcome|Arm C: LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
1243932|NCT00109590|O2|Outcome|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
1243933|NCT00109590|O1|Outcome|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally QD (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
1243934|NCT00109590|O3|Outcome|Arm C: LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
1243935|NCT00109590|O2|Outcome|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
1243936|NCT00109590|O1|Outcome|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
1243937|NCT00109590|O3|Outcome|Arm C: LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
1256733|NCT00064792|B3|Baseline|Total|Total of all reporting groups
1243938|NCT00109590|O2|Outcome|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
1243939|NCT00109590|O1|Outcome|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
1243940|NCT00109590|O3|Outcome|Arm C: LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
1243941|NCT00109590|O2|Outcome|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
1243942|NCT00109590|O1|Outcome|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
1243943|NCT00109590|O3|Outcome|Arm C: LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
1243944|NCT00109590|O2|Outcome|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, q3h during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
1243945|NCT00109590|O1|Outcome|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
1243946|NCT00109590|O3|Outcome|Arm C : LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, q3h during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
1243947|NCT00109590|O2|Outcome|Arm B: no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
1243948|NCT00109590|O1|Outcome|Arm A: LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7days postpartum.
1243949|NCT00109590|O2|Outcome|At Day 30 Ppm|ZDV, ddI, LPV/r x 30d
1243950|NCT00109590|O1|Outcome|Within 72 Hrs Ppm|ZDV, ddI, LPV/r x 30d
1243951|NCT00109590|O3|Outcome|Arm C : LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
1243952|NCT00109590|O2|Outcome|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
1243953|NCT00109590|O1|Outcome|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
1243954|NCT00109590|O3|Outcome|Arm C: LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor,ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
1243955|NCT00109590|O2|Outcome|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, q3h during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
1243956|NCT00109590|O1|Outcome|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
1243957|NCT00109590|E6|Reported Event|Infant: LPV/r x 30d|ZDV, ddI, LPV/r x 30d
1243958|NCT00109590|E5|Reported Event|Infant: no LPV/r|ZDV & ddI x 30d
1243962|NCT00109590|E1|Reported Event|Mother: LPV/r x 7d|NVP 200 mg orally, single dose at onset
1243963|NCT00109577|B3|Baseline|Total|Total of all reporting groups
1243964|NCT00109577|B2|Baseline|Micronutrient Formula|nutritional supplement
1243965|NCT00109577|B1|Baseline|Placebo Comparator|Placebo comparator
1243966|NCT00109577|P2|Participant Flow|Micronutrient Formula|nutritional supplement capsules containing 36-ingredients primarily vitamins and minerals; the supplement is referred to as MCN36, because it contains 36 nutrients.
1243967|NCT00109577|P1|Participant Flow|Placebo Comparator|Placebo comparator capsules
1243968|NCT00109577|O2|Outcome|Micronutrient Formula|nutritional supplement capsules
1243969|NCT00109577|O1|Outcome|Placebo Comparator|Placebo comparator capsules
1243970|NCT00109577|E2|Reported Event|Micronutrient Formula|nutritional supplement
1243971|NCT00109577|E1|Reported Event|Placebo Comparator|Placebo comparator
1243972|NCT00109473|B3|Baseline|Total|Total of all reporting groups
1243973|NCT00109473|B2|Baseline|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
1243974|NCT00109473|B1|Baseline|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
1243975|NCT00109473|P2|Participant Flow|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
1243976|NCT00109473|P1|Participant Flow|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
1243977|NCT00109473|O2|Outcome|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
1243978|NCT00109473|O1|Outcome|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
1243979|NCT00109473|O2|Outcome|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
1243985|NCT00109473|O2|Outcome|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
1243986|NCT00109473|O1|Outcome|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
1243987|NCT00109473|O2|Outcome|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
1243988|NCT00109473|O1|Outcome|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
1243989|NCT00109473|O2|Outcome|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
1243990|NCT00109473|O1|Outcome|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
1243991|NCT00109473|E3|Reported Event|Extension Phase|Eligible subjects from both group A and group B continued on growth hormone in a 52 week extension phase
1243992|NCT00109473|E2|Reported Event|Corticosteroid (CTX)|Subjects took corticosteroid as recommended by their physician
1243993|NCT00109473|E1|Reported Event|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
1243994|NCT00109343|B4|Baseline|Total|Total of all reporting groups
1243995|NCT00109343|B3|Baseline|Group 3 - ProQuad™ Followed by PREVNAR™|Group 3 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
1243996|NCT00109343|B2|Baseline|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
1243997|NCT00109343|B1|Baseline|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
1243998|NCT00109343|P3|Participant Flow|Group 3 - ProQuad™ Followed by PREVNAR™|Group 3 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
1243999|NCT00109343|P2|Participant Flow|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
1244000|NCT00109343|P1|Participant Flow|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
1244001|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
1244002|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
1244003|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
1244004|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
1244050|NCT00109031|O3|Outcome|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
1244346|NCT00107042|O2|Outcome|Ever Drank Alcohol: YES|Subjects who have drank alcohol
1244005|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
1244006|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
1244007|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
1244008|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
1244009|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
1244010|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
1244011|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
1244012|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
1244013|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
1244014|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
1244015|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
1244016|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
1244017|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
1244018|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
1244019|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
1244020|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
1244021|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
1244022|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
1244023|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
1244024|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
1244025|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
1244026|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
1244027|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
1244028|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
1244029|NCT00109343|O2|Outcome|Group 3 - ProQuad™ Followed by PREVNAR™|Group 3 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
1244030|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
1244031|NCT00109343|O2|Outcome|Group 3 - ProQuad™ Followed by PREVNAR™|Group 3 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
1244032|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
1244033|NCT00109343|O2|Outcome|Group 3 - ProQuad™ Followed by PREVNAR™|Group 3 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
1244034|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
1244035|NCT00109343|O2|Outcome|Group 3 - ProQuad™ Followed by PREVNAR™|Group 3 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
1244036|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
1244037|NCT00109343|E3|Reported Event|ProQuad™ (After Dose 2)|ProQuad™ (After Dose 2) includes Days 1 to 28 after the second dose of ProQuad™ (safety follow-up period 3 for Group 1, Group 2, and Group 3).
1244038|NCT00109343|E2|Reported Event|ProQuad™ Alone (After Dose 1)|ProQuad™ Alone (After Dose 1) includes Days 1 to 28 after the first dose of ProQuad™ (safety follow-up period 1 for Group 3 and safety follow-up period 2 for Group 2).
1244039|NCT00109343|E1|Reported Event|ProQuad™ + Prevnar™ (After Dose 1)|ProQuad™ + Prevnar™ (After Dose 1) includes Days 1 to 28 after the first dose of ProQuad™ (safety follow-up period 1 for Group 1)
1244040|NCT00109031|B5|Baseline|Total|Total of all reporting groups
1244041|NCT00109031|B4|Baseline|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
1244042|NCT00109031|B3|Baseline|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
1244043|NCT00109031|B2|Baseline|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
1244044|NCT00109031|B1|Baseline|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
1244045|NCT00109031|P4|Participant Flow|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
1244046|NCT00109031|P3|Participant Flow|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
1244047|NCT00109031|P2|Participant Flow|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and matched placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
1244048|NCT00109031|P1|Participant Flow|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg plus placebo to match the total volume equivalent to a 180 µg/kg dose on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC). Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
1244049|NCT00109031|O4|Outcome|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
1244347|NCT00107042|O1|Outcome|Ever Drank Alcohol: NO|Subjects who have never drank alcohol
1244051|NCT00109031|O2|Outcome|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
1244052|NCT00109031|O1|Outcome|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
1244053|NCT00109031|O4|Outcome|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
1244054|NCT00109031|O3|Outcome|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
1244055|NCT00109031|O2|Outcome|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
1244056|NCT00109031|O1|Outcome|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
1244057|NCT00109031|O4|Outcome|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
1244058|NCT00109031|O3|Outcome|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
1244059|NCT00109031|O2|Outcome|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
1244060|NCT00109031|O1|Outcome|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
1244096|NCT00108953|B3|Baseline|Total|Total of all reporting groups
1244061|NCT00109031|O4|Outcome|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
1244062|NCT00109031|O3|Outcome|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
1244063|NCT00109031|O2|Outcome|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
1244064|NCT00109031|O1|Outcome|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
1244065|NCT00109031|O4|Outcome|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
1244066|NCT00109031|O3|Outcome|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
1244067|NCT00109031|O2|Outcome|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
1244068|NCT00109031|O1|Outcome|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
1244069|NCT00109031|O4|Outcome|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
1244070|NCT00109031|O3|Outcome|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
1244071|NCT00109031|O2|Outcome|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
1244072|NCT00109031|O1|Outcome|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
1244073|NCT00109031|O4|Outcome|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
1244074|NCT00109031|O3|Outcome|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
1244075|NCT00109031|O2|Outcome|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
1244076|NCT00109031|O1|Outcome|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
1244077|NCT00109031|E4|Reported Event|Palifermin 180 μg/kg on Day −3 (D)|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
1244078|NCT00109031|E3|Reported Event|Palifermin 180 μg/kg on Day −2 (C)|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
1244079|NCT00109031|E2|Reported Event|Palifermin 180 μg/kg on Day −1 (B)|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
1244080|NCT00109031|E1|Reported Event|Palifermin 60 µg/kg for 3 Days (A)|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
1244081|NCT00109005|B3|Baseline|Total|Total of all reporting groups
1244082|NCT00109005|B2|Baseline|Cohort 2 - 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
1244083|NCT00109005|B1|Baseline|Cohort 1 - 25 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks
1244084|NCT00109005|P2|Participant Flow|Cohort 2 - 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
1244085|NCT00109005|P1|Participant Flow|Cohort 1 - 25 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks
1244086|NCT00109005|O1|Outcome|Cohort 1 & 2 -25 mg & 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
1244087|NCT00109005|O1|Outcome|Cohort 1 & 2 -25 mg & 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
1244088|NCT00109005|O1|Outcome|Cohort 1 & 2 -25 mg & 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
1244089|NCT00109005|O1|Outcome|Cohort 1 & 2 -25 mg & 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
1244090|NCT00109005|O1|Outcome|Cohort 1 & 2 -25 mg & 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
1244091|NCT00109005|O2|Outcome|Cohort 2 - 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
1244092|NCT00109005|O1|Outcome|Cohort 1 - 25 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks
1244093|NCT00109005|O1|Outcome|Cohort 1 & 2 -25 mg & 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
1244094|NCT00109005|E2|Reported Event|Cohort 2 - 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
1244095|NCT00109005|E1|Reported Event|Cohort 1 - 25 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks
1244097|NCT00108953|B2|Baseline|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
1244098|NCT00108953|B1|Baseline|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
1244099|NCT00108953|P2|Participant Flow|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
1244100|NCT00108953|P1|Participant Flow|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
1244101|NCT00108953|O2|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
1244102|NCT00108953|O1|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
1244103|NCT00108953|O2|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
1244104|NCT00108953|O1|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
1244105|NCT00108953|O2|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
1244106|NCT00108953|O1|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
1244107|NCT00108953|O2|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY 43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
1244108|NCT00108953|O1|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY 43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
1244109|NCT00108953|O2|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
1244110|NCT00108953|O1|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
1244111|NCT00108953|O2|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY 43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
1244112|NCT00108953|O1|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY 43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
1244113|NCT00108953|O2|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
1244114|NCT00108953|O1|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
1244294|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
1244115|NCT00108953|O2|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
1244116|NCT00108953|O1|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
1244117|NCT00108953|E2|Reported Event|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
1244118|NCT00108953|E1|Reported Event|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
1244119|NCT00108862|B3|Baseline|Total|Total of all reporting groups
1244120|NCT00108862|B2|Baseline|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
1244179|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
1244214|NCT00108485|O1|Outcome|Extended Release Niacin|"Extended release niacin 1500-2000 mg daily versus placebo comparator~Extended release niacin: Extended release niacin 1500-2000mg once daily"
1244121|NCT00108862|B1|Baseline|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
1244122|NCT00108862|P2|Participant Flow|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
1244123|NCT00108862|P1|Participant Flow|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
1244124|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
1244125|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
1244243|NCT00108355|E2|Reported Event|Vasoconstrictor (Treatment Group)|"After LVP, patients in this group received:~Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose"
1244543|NCT00108069|O3|Outcome|Grade 3|Severe adverse event
1244126|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
1244127|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
1244128|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
1244205|NCT00108524|O1|Outcome|Arm 1|Low carbohydrate ketogenic diet: Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
1244215|NCT00108485|E2|Reported Event|Placebo|Placebo tablets
1256668|NCT00065429|P2|Participant Flow|IMGN 10 mg/m2|Arm 2, Phase 1
1244129|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
1244130|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
1244131|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
1244132|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
1244133|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
1244134|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
1244135|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
1244136|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
1244206|NCT00108524|E2|Reported Event|Arm 2|Orlistat plus a low-fat diet: Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.
1244261|NCT00108303|O3|Outcome|Controls|Persons who are not relatives of persons with schizophrenia and do not have schizophrenia themselves.
1244137|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
1244138|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
1244139|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
1244140|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
1244141|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
1244142|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
1244143|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
1244144|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
1244207|NCT00108524|E1|Reported Event|Arm 1|Low carbohydrate ketogenic diet: Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
1244208|NCT00108485|B3|Baseline|Total|Total of all reporting groups
1244209|NCT00108485|B2|Baseline|Placebo|Placebo tablets
1244145|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
1244146|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
1244147|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
1244148|NCT00108862|E2|Reported Event|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
1244149|NCT00108862|E1|Reported Event|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
1244150|NCT00108732|B1|Baseline|Vaccinia/Fowlpox/GM-CSF|"Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.~Patients with biochemical or clinical disease progression may start androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months."
1244151|NCT00108732|P1|Participant Flow|Vaccinia/Fowlpox/GM-CSF|"There are two steps in this study. Patients receive vaccine treatment in Step 1. Patients with biochemical or clinical progression during Step 1 were eligible to continue on to androgen blockade in Step 2. This report includes information collected in Step 1 only.~Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.~Patients with biochemical or clinical disease progression may start Step II androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months."
1244152|NCT00108732|O1|Outcome|Vaccinia/Fowlpox/GM-CSF|"Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.~Patients with biochemical or clinical disease progression may start androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months."
1244210|NCT00108485|B1|Baseline|Extended Release Niacin|"Extended release niacin 1500-2000 mg daily versus placebo comparator~Extended release niacin: Extended release niacin 1500-2000mg once daily"
1244211|NCT00108485|P2|Participant Flow|Placebo|Placebo tablets
1244212|NCT00108485|P1|Participant Flow|Extended Release Niacin|"Extended release niacin 1500-2000 mg daily versus placebo comparator~Extended release niacin: Extended release niacin 1500-2000mg once daily"
1244153|NCT00108732|O1|Outcome|Vaccinia/Fowlpox/GM-CSF|"Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.~Patients with biochemical or clinical disease progression may start androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months."
1244154|NCT00108732|O1|Outcome|Vaccinia/Fowlpox/GM-CSF|"Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.~Patients with biochemical or clinical disease progression may start androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months."
1244155|NCT00108732|O1|Outcome|Vaccinia/Fowlpox/GM-CSF|"Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.~Patients with biochemical or clinical disease progression may start androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months."
1244156|NCT00108732|E1|Reported Event|Vaccinia/Fowlpox/GM-CSF|"Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.~Patients with biochemical or clinical disease progression may start androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months."
1244157|NCT00108628|B3|Baseline|Total|Total of all reporting groups
1244158|NCT00108628|B2|Baseline|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
1244159|NCT00108628|B1|Baseline|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
1244173|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
1244160|NCT00108628|P2|Participant Flow|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
1244161|NCT00108628|P1|Participant Flow|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
1244162|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
1244163|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
1244164|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
1244165|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
1244213|NCT00108485|O2|Outcome|Placebo|Placebo tablets
1244166|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
1244167|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
1244168|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
1244169|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
1244170|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
1244171|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
1244172|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
1244544|NCT00108069|O2|Outcome|Grade 2|Moderate adverse event
1244174|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
1244175|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
1244176|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
1244177|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
1244178|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
1244262|NCT00108303|O2|Outcome|Schizophrenia Relatives|Persons who are relatives of probands in Group 1.
1244180|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
1244181|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
1244182|NCT00108628|E2|Reported Event|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
1244183|NCT00108628|E1|Reported Event|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
1244184|NCT00108550|B3|Baseline|Total|Total of all reporting groups
1244185|NCT00108550|B2|Baseline|Placebo|Inert placebo capsules, 3 capsules three times a day for 12 weeks
1244186|NCT00108550|B1|Baseline|Gabapentin|gabapentin capsule 1200mg three times a day for 12 weeks
1244187|NCT00108550|P2|Participant Flow|Placebo|Inert placebo capsules, 3 capsules three times a day for 12 weeks
1244188|NCT00108550|P1|Participant Flow|Gabapentin|gabapentin capsule 1200mg three times a day for 12 weeks
1244189|NCT00108550|O2|Outcome|Gabapentin|gabapentin capsule 1200mg three times a day for 12 weeks
1244190|NCT00108550|O1|Outcome|Placebo|Inert placebo capsules, 3 capsules three times a day for 12 weeks
1244191|NCT00108550|O2|Outcome|Gabapentin|gabapentin capsule 1200mg three times a day for 12 weeks
1244192|NCT00108550|O1|Outcome|Placebo|Inert placebo capsules, 3 capsules three times a day for 12 weeks
1244193|NCT00108550|E2|Reported Event|Gabapentin|gabapentin capsule 1200mg three times a day for 12 weeks
1244194|NCT00108550|E1|Reported Event|Placebo|Inert placebo capsules, 3 capsules three times a day for 12 weeks
1244195|NCT00108524|B3|Baseline|Total|Total of all reporting groups
1244196|NCT00108524|B2|Baseline|Arm 2|"Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.~Orlistat plus a low-fat diet: Participants were instructed to restrict intake of total fat (<30% of daily energy), saturated fat (<10% of daily energy), cholesterol (<300 mg daily), and calories using pocket guides, handouts, and individualized goals. Recommended calorie intake was 500 to 1000 kcal below a participant's calculated weight maintenance intake. In addition, a 30-day supply of orlistat (120 mg before meals 3 times a day) was provided monthly."
1244293|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
1244545|NCT00108069|O1|Outcome|Grade 1|Mild adverse event
1244197|NCT00108524|B1|Baseline|Arm 1|"Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.~Low carbohydrate ketogenic diet: Participants were instructed to restrict carbohydrate intake initially to less than 20 g/d using pocket guides and handouts. Participants could eat unlimited meat and eggs, 112 g of hard cheese, 0.48 L of low-carbohydrate vegetables (eg, leafy greens), and 0.24 L of moderate-carbohydrate vegetables (eg, broccoli, asparagus) daily; calorie intake was not restricted. As participants approached their goal weight or if cravings threatened their adherence to the diet, they were advised to add approximately 5 g of carbohydrates to their daily intake each week until weight was maintained or cravings diminished."
1244198|NCT00108524|P2|Participant Flow|Low-Fat Diet Plus Orlistat|"Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.~Orlistat plus a low-fat diet: Participants were instructed to restrict intake of total fat (<30% of daily energy), saturated fat (<10% of daily energy), cholesterol (<300 mg daily), and calories using pocket guides, handouts, and individualized goals. Recommended calorie intake was 500 to 1000 kcal below a participant's calculated weight maintenance intake. In addition, a 30-day supply of orlistat (120 mg before meals 3 times a day) was provided monthly."
1244199|NCT00108524|P1|Participant Flow|Low Carbohydrate Ketogenic Diet|"Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.~Low carbohydrate ketogenic diet: Participants were instructed to restrict carbohydrate intake initially to less than 20 g/d using pocket guides and handouts. Participants could eat unlimited meat and eggs, 112 g of hard cheese, 0.48 L of low-carbohydrate vegetables (eg, leafy greens), and 0.24 L of moderate-carbohydrate vegetables (eg, broccoli, asparagus) daily; calorie intake was not restricted. As participants approached their goal weight or if cravings threatened their adherence to the diet, they were advised to add approximately 5 g of carbohydrates to their daily intake each week until weight was maintained or cravings diminished."
1244200|NCT00108524|O2|Outcome|Arm 2|Orlistat plus a low-fat diet: Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.
1244201|NCT00108524|O1|Outcome|Arm 1|Low carbohydrate ketogenic diet: Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
1244202|NCT00108524|O2|Outcome|Arm 2|Orlistat plus a low-fat diet: Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.
1244203|NCT00108524|O1|Outcome|Arm 1|Low carbohydrate ketogenic diet: Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
1244204|NCT00108524|O2|Outcome|Arm 2|Orlistat plus a low-fat diet: Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.
1244216|NCT00108485|E1|Reported Event|Extended Release Niacin|"Extended release niacin 1500-2000 mg daily versus placebo comparator~Extended release niacin: Extended release niacin 1500-2000mg once daily"
1244217|NCT00108433|B3|Baseline|Total|Total of all reporting groups
1244218|NCT00108433|B2|Baseline|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
1244219|NCT00108433|B1|Baseline|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
1244220|NCT00108433|P2|Participant Flow|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
1244221|NCT00108433|P1|Participant Flow|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
1244222|NCT00108433|O2|Outcome|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
1244223|NCT00108433|O1|Outcome|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
1244224|NCT00108433|O2|Outcome|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
1244225|NCT00108433|O1|Outcome|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
1244226|NCT00108433|O2|Outcome|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
1244227|NCT00108433|O1|Outcome|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
1244228|NCT00108433|O2|Outcome|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
1244229|NCT00108433|O1|Outcome|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
1244230|NCT00108433|O2|Outcome|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
1244231|NCT00108433|O1|Outcome|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
1244232|NCT00108433|E2|Reported Event|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
1244233|NCT00108433|E1|Reported Event|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
1244234|NCT00108355|B3|Baseline|Total|Total of all reporting groups
1244235|NCT00108355|B2|Baseline|Vasoconstrictor (Treatment Group)|"After LVP, patients in this group received:~Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose"
1244236|NCT00108355|B1|Baseline|Albumin (Control Group)|"After LVP, patients in this group received:~Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)"
1244237|NCT00108355|P2|Participant Flow|Vasoconstrictors (Study Group)|"After LVP, patients in this group received:~Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose"
1244238|NCT00108355|P1|Participant Flow|Albumin (Control Group)|"After LVP, patients in this group received:~Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)"
1244239|NCT00108355|O2|Outcome|Vasoconstrictor (Treatment Group)|"After LVP, patients in this group received:~Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose"
1244240|NCT00108355|O1|Outcome|Albumin (Control Group)|"After LVP, patients in this group received:~Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)"
1244241|NCT00108355|O2|Outcome|Vasoconstrictor (Treatment Group)|"After LVP, patients in this group received:~Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose"
1244242|NCT00108355|O1|Outcome|Albumin (Control Group)|"After LVP, patients in this group received:~Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)"
1244295|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
1244244|NCT00108355|E1|Reported Event|Albumin (Control Group)|"After LVP, patients in this group received:~Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)"
1244245|NCT00108342|B3|Baseline|Total|Total of all reporting groups
1244246|NCT00108342|B2|Baseline|NRT Computer Learning|Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only
1244247|NCT00108342|B1|Baseline|NRT Sampling|"Sampling = actual 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)~Nicotine gum - 2 mg and 4 mg~Nicotine lozenges - 2 mg and 4 mg~Nicotine inhaler - infrequent and frequent puffing for dosage (can yield 4 mg from 10 mg device)"
1244248|NCT00108342|P2|Participant Flow|NRT Computer Learning|Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only
1244249|NCT00108342|P1|Participant Flow|NRT Sampling|"Sampling = actual 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)~Nicotine gum - 2 mg and 4 mg~Nicotine lozenges - 2 mg and 4 mg~Nicotine inhaler - infrequent and frequent puffing for dosage (can yield 4 mg from 10 mg device)"
1244250|NCT00108342|O2|Outcome|NRT Computer Learning|Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only
1244251|NCT00108342|O1|Outcome|NRT Sampling|"Sampling = actual 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)~Nicotine gum - 2 mg and 4 mg~Nicotine lozenges - 2 mg and 4 mg~Nicotine inhaler - infrequent and frequent puffing for dosage (can yield 4 mg from 10 mg device)"
1244252|NCT00108342|E2|Reported Event|NRT Computer Learning|Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only
1244253|NCT00108342|E1|Reported Event|NRT Sampling|"Sampling = actual 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)~Nicotine gum - 2 mg and 4 mg~Nicotine lozenges - 2 mg and 4 mg~Nicotine inhaler - infrequent and frequent puffing for dosage (can yield 4 mg from 10 mg device)"
1244254|NCT00108303|B4|Baseline|Total|Total of all reporting groups
1244255|NCT00108303|B3|Baseline|Controls|Persons who are not related to persons in Arm 2 and do not have schizophrenia themselves.
1244256|NCT00108303|B2|Baseline|Schizophrenia Relatives|Persons who are first degree relatives of persons in Arm 1
1244257|NCT00108303|B1|Baseline|Schizophrenia Probands|Persons who meet DSM-IV criteria for schizophrenia or schizoaffective disorder
1244258|NCT00108303|P3|Participant Flow|Controls|Subjects who are unrelated to persons with schizophrenia and do not fulfill criteria for schizophrenia themselves.
1244259|NCT00108303|P2|Participant Flow|Schizophrenia Relatives|Subjects who are first degree relatives of subjects in Arm 1.
1244260|NCT00108303|P1|Participant Flow|Schizophrenia Probands|Persons who meet DSM-IV diagnostic criteria for schizophrenia or schizoaffective disorder.
1244263|NCT00108303|O1|Outcome|Schizophrenia Probands|Persons who meet DSM-IV diagnostic criteria for schizophrenia.
1244264|NCT00108303|O3|Outcome|Controls|Persons who do not have schizophrenia themselves and whose relatives do not have schizophrenia
1244265|NCT00108303|O2|Outcome|Schizophrenia Relatives|Persons who are siblings or children of someone with schizophrenia
1244266|NCT00108303|O1|Outcome|Schizophrenia Probands|Persons who have schizophrenia as determined by diagnosis
1244267|NCT00108303|O1|Outcome|Group 1|Subjects who receive genetic study.
1244268|NCT00108303|E3|Reported Event|Controls|Controls who do not have personal or family history of schizophrenia
1244269|NCT00108303|E2|Reported Event|Schizophrenia Relatives|Schizophrenia relatives who siblings or children of persons with schizophrenia
1244270|NCT00108303|E1|Reported Event|Schizophrenia Probands|Schizophrenia probands as diagnosed as having schizophrenia
1244271|NCT00108277|B4|Baseline|Total|Total of all reporting groups
1244272|NCT00108277|B3|Baseline|Waitlist|"Waitlist~Treatment as usual"
1244273|NCT00108277|B2|Baseline|Lower CO2|"Lower CO2~Breathing Training- Lower CO2: while breathing 9 minutes per minute, patients are instructed to lower CO2"
1244274|NCT00108277|B1|Baseline|Raise CO2|"Raise CO2~Breathing Training-Raise CO2: while breathing 9 minutes per minute, patients are instructed to raise CO2"
1244275|NCT00108277|P3|Participant Flow|Waitlist|Waitlist Treatment as Usual
1244276|NCT00108277|P2|Participant Flow|Lower CO2|"Lower CO2~Breathing Training- Lower CO2: while breathing 9 minutes per minute, patients are instructed to lower CO2"
1244277|NCT00108277|P1|Participant Flow|Raise CO2|"Raise CO2~Breathing Training-Raise CO2: while breathing 9 minutes per minute, patients are instructed to raise CO2"
1244278|NCT00108277|O3|Outcome|Waitlist|Waitlist Treatment as usual
1244279|NCT00108277|O2|Outcome|Lower CO2|"Lower CO2~Breathing Training- Lower CO2: while breathing 9 breaths per minute, patients are instructed to lower CO2"
1244280|NCT00108277|O1|Outcome|Raise CO2|"Raise CO2~Breathing Training-Raise CO2: while breathing 9 breaths per minute, patients are instructed to raise CO2"
1244281|NCT00108277|E3|Reported Event|Waitlist|Treatment as usual
1244282|NCT00108277|E2|Reported Event|Lower CO2|Breathing Training- Lower CO2: while breathing 9 minutes per minute, patients are instructed to lower CO2
1244283|NCT00108277|E1|Reported Event|Raise CO2|Breathing Training-Raise CO2: while breathing 9 minutes per minute, patients are instructed to raise CO2
1244284|NCT00107172|B3|Baseline|Total|Total of all reporting groups
1244285|NCT00107172|B2|Baseline|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
1244286|NCT00107172|B1|Baseline|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
1244287|NCT00107172|P2|Participant Flow|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
1244288|NCT00107172|P1|Participant Flow|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
1244289|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
1244290|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
1244291|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
1244292|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
1256775|NCT00064701|B4|Baseline|Total|Total of all reporting groups
1244296|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
1244297|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
1244298|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
1244299|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
1244300|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
1244301|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
1244302|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
1244303|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
1244304|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
1244305|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
1244306|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
1244307|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
1244308|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
1244309|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
1244310|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
1244311|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
1244312|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
1256669|NCT00065429|P1|Participant Flow|IMGN 5 mg/m2|Arm 1, Phase 1
1244313|NCT00107172|E2|Reported Event|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
1244314|NCT00107172|E1|Reported Event|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
1244315|NCT00107120|B3|Baseline|Total|Total of all reporting groups
1244316|NCT00107120|B2|Baseline|Placebo|Once daily oral administration of placebo tablets
1244317|NCT00107120|B1|Baseline|Escitalopram|Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability.
1244318|NCT00107120|P2|Participant Flow|Placebo|Once daily oral administration of placebo tablets
1244319|NCT00107120|P1|Participant Flow|Escitalopram|Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability.
1244320|NCT00107120|O2|Outcome|Placebo|Once daily oral administration of placebo tablets
1244321|NCT00107120|O1|Outcome|Escitalopram|Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability.
1244322|NCT00107120|O2|Outcome|Placebo|Once daily oral administration of placebo tablets
1244323|NCT00107120|O1|Outcome|Escitalopram|Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability.
1244324|NCT00107120|O2|Outcome|Placebo|Once daily oral administration of placebo tablets
1244325|NCT00107120|O1|Outcome|Escitalopram|Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability.
1244326|NCT00107120|E2|Reported Event|Placebo|Once daily oral administration of placebo tablets
1244327|NCT00107120|E1|Reported Event|Escitalopram|Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability.
1244328|NCT00107042|B3|Baseline|Total|Total of all reporting groups
1244329|NCT00107042|B2|Baseline|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
1244330|NCT00107042|B1|Baseline|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
1244331|NCT00107042|P2|Participant Flow|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
1244332|NCT00107042|P1|Participant Flow|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
1244333|NCT00107042|O2|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
1244334|NCT00107042|O1|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
1244335|NCT00107042|O2|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
1244336|NCT00107042|O1|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
1244337|NCT00107042|O1|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
1244338|NCT00107042|O1|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
1244339|NCT00107042|O1|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
1244340|NCT00107042|O2|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
1244341|NCT00107042|O1|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
1244342|NCT00107042|O2|Outcome|Ever Used Drugs Not Prescribed: YES|Subjects who have used drugs that were not prescribed.
1244343|NCT00107042|O1|Outcome|Ever Used Drugs Not Prescribed: NO|Subjects who have never used drugs that were not prescribed.
1244344|NCT00107042|O2|Outcome|Ever Smoked Marijuana: YES|Subjects who have smoked marijuana
1244345|NCT00107042|O1|Outcome|Ever Smoked Marijuana: NO|Subjects who have never smoked marijuana
1256935|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
1244348|NCT00107042|O3|Outcome|>= 6 Female Sex Partners|Male and female subjects who have had 6 or more lifetime female sex partners
1244349|NCT00107042|O2|Outcome|1-5 Female Sex Partners|Male and female Subjects who have had 1 - 5 lifetime female sex partners
1244350|NCT00107042|O1|Outcome|0 Female Sex Partners|Male and female subjects who have never had a female sex partner
1244351|NCT00107042|O3|Outcome|>= 6 Male Sex Partners|Male and female subjects who have had 6 or more lifetime male sex partners
1244352|NCT00107042|O2|Outcome|1-5 Male Sex Partners|Male and female subjects who have had 1 - 5 lifetime male sex partners
1244353|NCT00107042|O1|Outcome|0 Male Sex Partners|Male and female subjects who have never had a male sex partner
1244354|NCT00107042|O3|Outcome|>= 6 Sex Partners|Subjects who have had 6 or more lifetime sex partners
1244355|NCT00107042|O2|Outcome|1 - 5 Sex Partners|Subjects who have had 1 - 5 lifetime sex partners
1244356|NCT00107042|O1|Outcome|0 Sex Partners|Subjects who have never had a sex partner
1244357|NCT00107042|O3|Outcome|15-17 Years of Age|Subjects who reported they first had anal or vaginal sex because they wanted to between the ages of 15 and 17, inclusive
1244358|NCT00107042|O2|Outcome|12-14 Years of Age|Subjects who reported they first had anal or vaginal sex because they wanted to between the ages of 12 and 14, inclusive
1244359|NCT00107042|O1|Outcome|Never|Subjects who reported they never had anal or vaginal sex because they wanted to.
1244360|NCT00107042|O2|Outcome|Gay (Homosexual), Bi (Bisexual), Not Sure or Undecided|Subjects who were either gay (homosexual), bisexual, not sure or undecided.
1244361|NCT00107042|O1|Outcome|Straight (Heterosexual)|Subjects who were straight (heterosexual)
1244362|NCT00107042|O2|Outcome|Ever Smoked Cigarettes: YES|Subjects who have smoked cigarettes
1244363|NCT00107042|O1|Outcome|Ever Smoked Cigarettes: NO|Subjects who have never smoked cigarettes
1244364|NCT00107042|O2|Outcome|Overweight and Obese (>=25.0)|Subjects whose BMIs were >= 25.0
1244365|NCT00107042|O1|Outcome|Normal and Underweight (< 25.0)|Subjects whose BMIs were normal to < 25.0
1244366|NCT00107042|O2|Outcome|Tanner Stages 1-4 (Males)|Males who were self-assessed and categorized to Tanner Stages 1, 2, 3, or 4.
1260632|NCT00041756|O1|Outcome|Placebo Tablet|Placebo tablet dosed BID
1244367|NCT00107042|O1|Outcome|Tanner Stage 5 (Males)|Males who were self-assessed and categorized to Tanner Stage 5.
1244368|NCT00107042|O2|Outcome|Tanner Stages 1-4 (Females)|Females who were self-assessed and categorized to Tanner Stages 1, 2, 3, or 4.
1244369|NCT00107042|O1|Outcome|Tanner Stage 5 (Females)|Females who were self-assessed and categorized to Tanner Stage 5.
1244370|NCT00107042|O3|Outcome|Black/African American|Subjects who reported their race to be black or African American
1244371|NCT00107042|O2|Outcome|Other/Mixed Race|Subjects who reported their race to be other than white, black, or of mixed race.
1244372|NCT00107042|O1|Outcome|White|Subjects who reported their race to be white.
1244373|NCT00107042|O2|Outcome|Hispanic|Subjects who reported they were of Hispanic ethnicity.
1244374|NCT00107042|O1|Outcome|Not Hispanic|Subjects who reported they were not of Hispanic ethnicity.
1244375|NCT00107042|O2|Outcome|Male|Male Subjects
1244376|NCT00107042|O1|Outcome|Female|Female Subjects
1244377|NCT00107042|O2|Outcome|12-14 Years of Age|Subjects between the ages of 12 and 14 years, inclusive
1244378|NCT00107042|O1|Outcome|15-17 Years of Age|Subjects between the ages of 15 and 17 years, inclusive
1244379|NCT00107042|O2|Outcome|Baltimore|Clinical site where subjects were enrolled.
1244380|NCT00107042|O1|Outcome|Other Sites|All other clinical sites (besides the Baltimore site) where subjects were enrolled.
1244381|NCT00107042|O2|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
1244382|NCT00107042|O1|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Wk 24
1244383|NCT00107042|O1|Outcome|All Participants|All participants who had a week 28 hepatitis B antibody titer and the week 28 visit window was no more than 8 weeks after the second vaccination (per protocol). Participants were vaccinated at Week 0 and Week 24 with either Recombivax or Twinrix.
1244384|NCT00107042|O2|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
1244385|NCT00107042|O1|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
1244386|NCT00107042|O2|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
1244387|NCT00107042|O1|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
1244388|NCT00107042|O2|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
1244389|NCT00107042|O1|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
1244390|NCT00107042|O2|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
1244391|NCT00107042|O1|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
1244392|NCT00107042|E2|Reported Event|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
1244393|NCT00107042|E1|Reported Event|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
1244394|NCT00106964|B4|Baseline|Total|Total of all reporting groups
1244395|NCT00106964|B3|Baseline|3: Twinrix 20 mcg|20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
1244396|NCT00106964|B2|Baseline|2: Engerix 40 mcg|40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
1244397|NCT00106964|B1|Baseline|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
1244398|NCT00106964|P3|Participant Flow|3: Twinrix 20 mcg|20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
1244399|NCT00106964|P2|Participant Flow|2: Engerix 40 mcg|40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
1244400|NCT00106964|P1|Participant Flow|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
1244401|NCT00106964|O3|Outcome|3: Twinrix 20 mcg|20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
1244402|NCT00106964|O2|Outcome|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
1244592|NCT00107900|O5|Outcome|60mg BID|60mg edoxaban administered twice daily (BID)
1244403|NCT00106964|O1|Outcome|2: Engerix 40 mcg|40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
1244404|NCT00106964|O3|Outcome|3: Twinrix 20 mcg|20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
1244405|NCT00106964|O2|Outcome|2: Engerix 40 mcg|40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
1244406|NCT00106964|O1|Outcome|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
1244407|NCT00106964|O3|Outcome|3: Twindrix 20 mcg|20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
1244408|NCT00106964|O2|Outcome|2: Engerix 40 mcg|40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
1244409|NCT00106964|O1|Outcome|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
1244410|NCT00106964|O3|Outcome|3: Twinrix 20 mcg|Twinrix 20 mcg vaccine. Number of participants with a Grade 1 event that was definitely related to study drug as determined by the Site Investigator.
1244411|NCT00106964|O2|Outcome|2: Engerix 40 mcg|Engerix 40 mcg vaccine. Number of participants with a Grade 1 event that was definitely related to study drug as determined by the Site Investigator.
1244412|NCT00106964|O1|Outcome|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Number of participants with a Grade 1 event that was definitely related to study drug as determined by the Site Investigator.
1244413|NCT00106964|O3|Outcome|3: Twinrix 20 mcg|Twinrix 20 mcg vaccine. Number of participants with a Grade 1 event that was probably or possibly related to study drug as determined by the Site Investigator.
1244414|NCT00106964|O2|Outcome|2: Engerix 40 mcg|Engerix 40 mcg vaccine. Number of participants with a Grade 1 event that was probably or possibly related to study drug as determined by the Site Investigator.
1244415|NCT00106964|O1|Outcome|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Number of participants with a Grade 1 event that was probably or possibly related to study drug as determined by the Site Investigator.
1244416|NCT00106964|O3|Outcome|3: Twinrix 20 mcg|20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
1244417|NCT00106964|O2|Outcome|2: Engerix 40 mcg|40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
1244418|NCT00106964|O1|Outcome|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
1244419|NCT00106964|E3|Reported Event|3. Twinrix 20 mcg|20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
1244420|NCT00106964|E2|Reported Event|2: Engerix 40 mcg|40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
1244421|NCT00106964|E1|Reported Event|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
1244422|NCT00106938|B3|Baseline|Total|Total of all reporting groups
1244423|NCT00106938|B2|Baseline|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244424|NCT00106938|B1|Baseline|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244425|NCT00106938|P2|Participant Flow|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244426|NCT00106938|P1|Participant Flow|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244427|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244428|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244429|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244430|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244431|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244432|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244433|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244434|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244435|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244436|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244437|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244593|NCT00107900|O4|Outcome|60mg QD|60mg edoxaban administered once daily (QD)
1244438|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244439|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244440|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244441|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244442|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244443|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244444|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244445|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244446|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244447|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244478|NCT00108160|O1|Outcome|Mupirocin Ointment (Treatment)|Mupirocin 2% in polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
1244448|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244449|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244450|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244451|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244452|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244453|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244454|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244455|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244456|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244457|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244458|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244459|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244460|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244461|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244462|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244463|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244464|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244546|NCT00108069|O2|Outcome|AG (Anaplastic Glioma)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
1244465|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244466|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244467|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244468|NCT00106938|E2|Reported Event|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244469|NCT00106938|E1|Reported Event|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
1244470|NCT00108160|B3|Baseline|Total|Total of all reporting groups
1244471|NCT00108160|B2|Baseline|Polyethylene Glycol Ointment (Placebo)|Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months (Placebo Group).
1244472|NCT00108160|B1|Baseline|Mupirocin Ointment (Treatment)|Mupirocin 2% in polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months (Treatment Group).
1244473|NCT00108160|P2|Participant Flow|Polyethylene Glycol Ointment (Placebo)|Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
1244474|NCT00108160|P1|Participant Flow|Mupirocin Ointment (Treatment)|Mupirocin 2% in polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
1244475|NCT00108160|O2|Outcome|Polyethylene Glycol Ointment [Placebo]|Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
1244476|NCT00108160|O1|Outcome|Mupirocin Ointment [Treatment]|Mupirocin 2% in polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
1244477|NCT00108160|O2|Outcome|Polyethylene Glycol Ointment (Placebo)|Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
1244617|NCT00107900|E4|Reported Event|60mg QD|60mg edoxaban administered once daily (QD)
1244479|NCT00108160|O2|Outcome|Polyethylene Glycol Ointment (Placebo)|Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
1244480|NCT00108160|O1|Outcome|Mupirocin Ointment (Treatment)|Mupirocin 2% in polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
1244481|NCT00108160|E2|Reported Event|Polyethylene Glycol Ointment|Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
1244482|NCT00108160|E1|Reported Event|Mupirocin Ointment|Mupirocin 2% in polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
1244483|NCT00108082|B4|Baseline|Total|Total of all reporting groups
1244484|NCT00108082|B3|Baseline|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1244485|NCT00108082|B2|Baseline|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1244486|NCT00108082|B1|Baseline|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
1244487|NCT00108082|P3|Participant Flow|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1244488|NCT00108082|P2|Participant Flow|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1244489|NCT00108082|P1|Participant Flow|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
1244490|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1244491|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1244492|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
1244493|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1244494|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1244495|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
1244496|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1244497|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1244498|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
1244499|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1244500|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1244501|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
1244502|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1244503|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1260666|NCT00041392|O1|Outcome|Magnesium|100 mg/kg magnesium
1244504|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
1244505|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1244506|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1244507|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
1244508|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1244509|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1244510|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
1244511|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1244512|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1244513|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
1244514|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1244515|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1244516|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
1244591|NCT00107900|O6|Outcome|120mg QD|120mg edoxaban administered once daily (QD)
1244517|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1244518|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1244519|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
1244520|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1244521|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1244522|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
1244523|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1244524|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1244525|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
1244618|NCT00107900|E3|Reported Event|30mg BID|30mg edoxaban administered twice daily (BID)
1244619|NCT00107900|E2|Reported Event|30mg QD|30mg edoxaban administered once daily (QD)
1244526|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1244527|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1244528|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
1244529|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1244530|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1244531|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
1244532|NCT00108082|E3|Reported Event|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1244533|NCT00108082|E2|Reported Event|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
1244534|NCT00108082|E1|Reported Event|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
1244535|NCT00108069|B3|Baseline|Total|Total of all reporting groups
1244536|NCT00108069|B2|Baseline|AG (Anaplastic Glioma)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
1244537|NCT00108069|B1|Baseline|GBM (Glioblastoma Multiforme)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
1244538|NCT00108069|P2|Participant Flow|AG (Anaplastic Glioma)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
1244539|NCT00108069|P1|Participant Flow|GBM (Glioblastoma Multiforme)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
1244540|NCT00108069|O6|Outcome|Total|Total number of participants.
1244541|NCT00108069|O5|Outcome|Grade 5|Death related to adverse event
1244542|NCT00108069|O4|Outcome|Grade 4|Life-threatening or disabling adverse event
1244547|NCT00108069|O1|Outcome|GBM (Glioblastoma Multiforme)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
1244548|NCT00108069|O2|Outcome|AG (Anaplastic Glioma)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
1244549|NCT00108069|O1|Outcome|GBM (Glioblastoma Multiforme)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
1244550|NCT00108069|E2|Reported Event|AG (Anaplastic Glioma)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
1244551|NCT00108069|E1|Reported Event|GBM (Glioblastoma Multiforme)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
1244552|NCT00107991|B1|Baseline|Etanercept|50 mg/week subcutaneously
1244553|NCT00107991|P1|Participant Flow|Etanercept|50 mg/week subcutaneously
1244554|NCT00107991|O1|Outcome|Etanercept|50 mg/week subcutaneously
1244555|NCT00107991|O1|Outcome|Etanercept|50 mg/week subcutaneously
1244556|NCT00107991|O1|Outcome|Etanercept|50 mg/week subcutaneously
1244557|NCT00107991|O1|Outcome|Etanercept|50 mg/week subcutaneously
1244558|NCT00107991|O1|Outcome|Etanercept|50 mg/week subcutaneously
1244559|NCT00107991|E1|Reported Event|Etanercept|50 mg/week subcutaneously
1244560|NCT00107978|B3|Baseline|Total|Total of all reporting groups
1244561|NCT00107978|B2|Baseline|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gm every 12 hours. The maximum allowable treatment period was 14 days.
1244562|NCT00107978|B1|Baseline|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
1244620|NCT00107900|E1|Reported Event|15mg BID|15mg edoxaban administered twice daily (BID)
1244621|NCT00107783|B3|Baseline|Total|Total of all reporting groups
1244563|NCT00107978|P2|Participant Flow|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gm every 12 hours. The maximum allowable treatment period was 14 days.
1244564|NCT00107978|P1|Participant Flow|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
1244565|NCT00107978|O2|Outcome|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gm every 12 hours. The maximum allowable treatment period was 14 days.
1244566|NCT00107978|O1|Outcome|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
1244567|NCT00107978|E2|Reported Event|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gm every 12 hours. The maximum allowable treatment period was 14 days.
1244568|NCT00107978|E1|Reported Event|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
1244569|NCT00107952|B3|Baseline|Total|Total of all reporting groups
1244570|NCT00107952|B2|Baseline|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV administered every 12 hrs.
1244571|NCT00107952|B1|Baseline|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.
1244572|NCT00107952|P2|Participant Flow|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV administered every 12 hrs.
1244573|NCT00107952|P1|Participant Flow|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.
1244574|NCT00107952|O2|Outcome|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV administered every 12 hrs.
1244575|NCT00107952|O1|Outcome|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.
1244576|NCT00107952|E2|Reported Event|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV administered every 12 hrs.
1244577|NCT00107952|E1|Reported Event|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.
1244578|NCT00107900|B7|Baseline|Total|Total of all reporting groups
1244579|NCT00107900|B6|Baseline|120mg QD|120mg edoxaban administered once daily (QD)
1244580|NCT00107900|B5|Baseline|60mg BID|60mg edoxaban administered twice daily (BID)
1244581|NCT00107900|B4|Baseline|60mg QD|60mg edoxaban administered once daily (QD)
1244582|NCT00107900|B3|Baseline|30mg BID|30mg edoxaban administered twice daily (BID)
1244583|NCT00107900|B2|Baseline|30mg QD|30mg edoxaban administered once daily (QD)
1244584|NCT00107900|B1|Baseline|15mg BID|15mg edoxaban administered twice daily (BID)
1244585|NCT00107900|P6|Participant Flow|120mg QD|120mg edoxaban administered once daily (QD)
1244586|NCT00107900|P5|Participant Flow|60mg BID|60mg edoxaban administered twice daily (BID)
1244587|NCT00107900|P4|Participant Flow|60mg QD|60mg edoxaban administered once daily (QD)
1244588|NCT00107900|P3|Participant Flow|30mg BID|30mg edoxaban administered twice daily (BID)
1244589|NCT00107900|P2|Participant Flow|30mg QD|30mg edoxaban administered once daily (QD)
1244590|NCT00107900|P1|Participant Flow|15mg BID|15mg edoxaban administered twice daily (BID)
1244594|NCT00107900|O3|Outcome|30mg BID|30mg edoxaban administered twice daily (BID)
1244595|NCT00107900|O2|Outcome|30mg QD|30mg edoxaban administered once daily (QD)
1244596|NCT00107900|O1|Outcome|15mg BID|15mg edoxaban administered twice daily (BID)
1244597|NCT00107900|O6|Outcome|120mg QD|120mg edoxaban administered once daily (QD)
1244598|NCT00107900|O5|Outcome|60mg BID|60mg edoxaban administered twice daily (BID)
1244599|NCT00107900|O4|Outcome|60mg QD|60mg edoxaban administered once daily (QD)
1244600|NCT00107900|O3|Outcome|30mg BID|30mg edoxaban administered twice daily (BID)
1244601|NCT00107900|O2|Outcome|30mg QD|30mg edoxaban administered once daily (QD)
1244602|NCT00107900|O1|Outcome|15mg BID|15mg edoxaban administered twice daily (BID)
1244603|NCT00107900|O6|Outcome|120mg QD|120mg edoxaban administered once daily (QD)
1244604|NCT00107900|O5|Outcome|60mg BID|60mg edoxaban administered twice daily (BID)
1244605|NCT00107900|O4|Outcome|60mg QD|60mg edoxaban administered once daily (QD)
1244606|NCT00107900|O3|Outcome|30mg BID|30mg edoxaban administered twice daily (BID)
1244607|NCT00107900|O2|Outcome|30mg QD|30mg edoxaban administered once daily (QD)
1244608|NCT00107900|O1|Outcome|15mg BID|15mg edoxaban administered twice daily (BID)
1244609|NCT00107900|O6|Outcome|120mg QD|120mg edoxaban administered once daily (QD)
1244610|NCT00107900|O5|Outcome|60mg BID|60mg edoxaban administered twice daily (BID)
1244611|NCT00107900|O4|Outcome|60mg QD|60mg edoxaban administered once daily (QD)
1244612|NCT00107900|O3|Outcome|30mg BID|30mg edoxaban administered twice daily (BID)
1244613|NCT00107900|O2|Outcome|30mg QD|30mg edoxaban administered once daily (QD)
1244614|NCT00107900|O1|Outcome|15mg BID|15mg edoxaban administered twice daily (BID)
1244615|NCT00107900|E6|Reported Event|120mg QD|120mg edoxaban administered once daily (QD)
1244616|NCT00107900|E5|Reported Event|60mg BID|60mg edoxaban administered twice daily (BID)
1244622|NCT00107783|B2|Baseline|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
1244623|NCT00107783|B1|Baseline|Control|No treatment
1244624|NCT00107783|P2|Participant Flow|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
1244625|NCT00107783|P1|Participant Flow|Control|No treatment
1244626|NCT00107783|O2|Outcome|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
1244627|NCT00107783|O1|Outcome|Control|No treatment
1244628|NCT00107783|O2|Outcome|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
1244629|NCT00107783|O1|Outcome|Control|No treatment
1244630|NCT00107783|O2|Outcome|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
1244631|NCT00107783|O1|Outcome|Control|No treatment
1244632|NCT00107783|O2|Outcome|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
1244633|NCT00107783|O1|Outcome|Control|No treatment
1244634|NCT00107783|O2|Outcome|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
1244635|NCT00107783|O1|Outcome|Control|No treatment
1244636|NCT00107783|E2|Reported Event|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
1244637|NCT00107783|E1|Reported Event|Control|No treatment
1244638|NCT00107653|B3|Baseline|Total|Total of all reporting groups
1244639|NCT00107653|B2|Baseline|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
1244640|NCT00107653|B1|Baseline|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
1244641|NCT00107653|P2|Participant Flow|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
1244642|NCT00107653|P1|Participant Flow|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
1244643|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
1244644|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
1244645|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
1244701|NCT00107575|O1|Outcome|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
1244703|NCT00107575|O1|Outcome|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
1244646|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
1244647|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
1244648|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
1244649|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
1244650|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
1244651|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
1244652|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
1244653|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
1244654|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
1244655|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
1244656|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
1244657|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
1244658|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
1244659|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
1244660|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
1244661|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
1244702|NCT00107575|O2|Outcome|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
1244662|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
1244663|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
1244664|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
1244665|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
1244666|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
1244667|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
1244713|NCT00107536|O1|Outcome|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
1244668|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
1244669|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
1244670|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
1244671|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
1244672|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
1244673|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
1244674|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
1244675|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
1244676|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
1244677|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
1244678|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
1244679|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
1244680|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
1244681|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
1244682|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
1244683|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
1244714|NCT00107536|O1|Outcome|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
1244684|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
1244685|NCT00107653|E2|Reported Event|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
1244686|NCT00107653|E1|Reported Event|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
1244687|NCT00107614|B1|Baseline|Waldenstrom's Macroglobulinemia Patients|Participants must have a pathological diagnosis of Waldenstrom’s Macroglobulinemia, with advanced and/or symptomatic disease requiring therapy. At least one of the inclusion criteria:
1244688|NCT00107614|P1|Participant Flow|Waldenstrom's Macroglobulinemia Patients|Participants must have a pathological diagnosis of Waldenstrom’s Macroglobulinemia, with advanced and/or symptomatic disease requiring therapy. At least one of the inclusion criteria:
1244689|NCT00107614|O1|Outcome|Waldenstrom's Macroglobulinemia Patients|Participants must have a pathological diagnosis of Waldenstrom’s Macroglobulinemia, with advanced and/or symptomatic disease requiring therapy. At least one of the inclusion criteria:
1244690|NCT00107614|E1|Reported Event|Waldenstrom's Macroglobulinemia Patients|Participants must have a pathological diagnosis of Waldenstrom’s Macroglobulinemia, with advanced and/or symptomatic disease requiring therapy. At least one of the inclusion criteria:
1244691|NCT00107575|B3|Baseline|Total|Total of all reporting groups
1244692|NCT00107575|B2|Baseline|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
1244693|NCT00107575|B1|Baseline|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
1244694|NCT00107575|P2|Participant Flow|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
1244695|NCT00107575|P1|Participant Flow|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
1244696|NCT00107575|O2|Outcome|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
1244697|NCT00107575|O1|Outcome|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
1244698|NCT00107575|O2|Outcome|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
1244699|NCT00107575|O1|Outcome|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
1244700|NCT00107575|O2|Outcome|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
1244704|NCT00107575|O2|Outcome|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
1244705|NCT00107575|O1|Outcome|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
1244706|NCT00107575|E2|Reported Event|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
1244707|NCT00107575|E1|Reported Event|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
1244708|NCT00107536|B1|Baseline|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
1244709|NCT00107536|P1|Participant Flow|Lapatinib|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
1244710|NCT00107536|O1|Outcome|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
1244711|NCT00107536|O1|Outcome|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
1244712|NCT00107536|O1|Outcome|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
1244782|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244715|NCT00107536|O1|Outcome|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
1244716|NCT00107536|O1|Outcome|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
1244717|NCT00107536|E1|Reported Event|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
1244718|NCT00107380|B1|Baseline|R-CHOP + I-131-tositumomab|Patients receive cyclophosphamide 750 mg/m^2 IV over 15 minutes, doxorubicin 50 mg/m^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177
1244719|NCT00107380|P1|Participant Flow|R-CHOP + I-131-tositumomab|Patients receive cyclophosphamide 750 mg/m^2 IV over 15 minutes, doxorubicin 50 mg/m^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177.
1244720|NCT00107380|O1|Outcome|R-CHOP + I-131-tositumomab|Patients receive cyclophosphamide 750 mg/m^2 IV over 15 minutes, doxorubicin 50 mg/m^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177
1244721|NCT00107380|O1|Outcome|R-CHOP + I-131-tositumomab|Patients receive cyclophosphamide 750 mg/m^2 IV over 15 minutes, doxorubicin 50 mg/m^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177.
1244722|NCT00107380|O1|Outcome|R-CHOP + I-131-tositumomab|Patients receive cyclophosphamide 750 mg/m^2 IV over 15 minutes, doxorubicin 50 mg/m^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177
1244723|NCT00107380|E1|Reported Event|R-CHOP + I-131-tositumomab|Patients receive cyclophosphamide 750 mg/m^2 IV over 15 minutes, doxorubicin 50 mg/m^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177
1244724|NCT00107315|B1|Baseline|Combination of Capecitabine and Bevacizumab|Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
1244725|NCT00107315|P1|Participant Flow|Combination of Capecitabine and Bevacizumab|Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
1244726|NCT00107315|O1|Outcome|Combination of Capecitabine and Bevacizumab|Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
1244763|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244727|NCT00107315|O1|Outcome|Combination of Capecitabine and Bevacizumab|Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
1244728|NCT00107315|O1|Outcome|Combination of Capecitabine and Bevacizumab|Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
1244729|NCT00107315|O1|Outcome|Combination of Capecitabine and Bevacizumab|Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
1244730|NCT00107315|E1|Reported Event|Combination of Capecitabine and Bevacizumab|Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
1244731|NCT00107276|B1|Baseline|Cyclophosphamide and Capecitabine|cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
1244732|NCT00107276|P1|Participant Flow|Cyclophosphamide and Capecitabine|cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
1244733|NCT00107276|O1|Outcome|Cyclophosphamide and Capecitabine|
1244734|NCT00107276|O1|Outcome|Cyclophosphamide and Capecitabine|cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
1244735|NCT00107276|O1|Outcome|Cyclophosphamide and Capecitabine|cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
1244736|NCT00107276|E1|Reported Event|Cyclophosphamide and Capecitabine|
1244783|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244784|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244785|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244786|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244787|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244788|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244737|NCT00107198|B1|Baseline|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).~IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).~doxorubicin hydrochloride: Given IV~conventional surgery: Undergo surgery~cyclophosphamide: Given IV~prednisone: Given IV or PO~vincristine sulfate: Given IV~radiation therapy: Undergo IFRT"
1244738|NCT00107198|P1|Participant Flow|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).~IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).~doxorubicin hydrochloride: Given IV~conventional surgery: Undergo surgery~cyclophosphamide: Given IV~prednisone: Given IV or PO~vincristine sulfate: Given IV~radiation therapy: Undergo IFRT"
1244739|NCT00107198|O1|Outcome|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).~IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).~doxorubicin hydrochloride: Given IV~conventional surgery: Undergo surgery~cyclophosphamide: Given IV~prednisone: Given IV or PO~vincristine sulfate: Given IV~radiation therapy: Undergo IFRT"
1244740|NCT00107198|O1|Outcome|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).~IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).~doxorubicin hydrochloride: Given IV~conventional surgery: Undergo surgery~cyclophosphamide: Given IV~prednisone: Given IV or PO~vincristine sulfate: Given IV~radiation therapy: Undergo IFRT"
1244741|NCT00107198|O1|Outcome|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).~IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).~doxorubicin hydrochloride: Given IV~conventional surgery: Undergo surgery~cyclophosphamide: Given IV~prednisone: Given IV or PO~vincristine sulfate: Given IV~radiation therapy: Undergo IFRT"
1244764|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1256936|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
1244742|NCT00107198|O1|Outcome|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).~IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).~doxorubicin hydrochloride: Given IV~conventional surgery: Undergo surgery~cyclophosphamide: Given IV~prednisone: Given IV or PO~vincristine sulfate: Given IV~radiation therapy: Undergo IFRT"
1244743|NCT00107198|O1|Outcome|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).~IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).~doxorubicin hydrochloride: Given IV~conventional surgery: Undergo surgery~cyclophosphamide: Given IV~prednisone: Given IV or PO~vincristine sulfate: Given IV~radiation therapy: Undergo IFRT"
1244789|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244790|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244791|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244792|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244793|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244794|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244744|NCT00107198|E1|Reported Event|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).~IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).~doxorubicin hydrochloride: Given IV~conventional surgery: Undergo surgery~cyclophosphamide: Given IV~prednisone: Given IV or PO~vincristine sulfate: Given IV~radiation therapy: Undergo IFRT"
1244745|NCT00106704|B3|Baseline|Total|Total of all reporting groups
1244746|NCT00106704|B2|Baseline|Placebo/ Pioglitazone|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
1244747|NCT00106704|B1|Baseline|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
1244748|NCT00106704|P2|Participant Flow|Placebo/ Pioglitazone|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
1244749|NCT00106704|P1|Participant Flow|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
1244750|NCT00106704|O2|Outcome|Placebo/ Pioglitazone|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
1244751|NCT00106704|O1|Outcome|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
1244752|NCT00106704|O2|Outcome|Placebo/ Pioglitazone|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
1244753|NCT00106704|O1|Outcome|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
1244754|NCT00106704|E2|Reported Event|Placebo/ Pioglitazone|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
1244755|NCT00106704|E1|Reported Event|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
1244756|NCT00106639|B4|Baseline|Total|Total of all reporting groups
1244757|NCT00106639|B3|Baseline|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244758|NCT00106639|B2|Baseline|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244759|NCT00106639|B1|Baseline|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244760|NCT00106639|P3|Participant Flow|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244761|NCT00106639|P2|Participant Flow|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244762|NCT00106639|P1|Participant Flow|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244765|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244766|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244767|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244768|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244769|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244770|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244771|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244772|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244773|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244774|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244775|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244776|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244777|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244778|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244779|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244780|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244781|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1260667|NCT00041392|E2|Reported Event|0.9 % Saline|100 mg/kg 0.9 % saline
1244795|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244796|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244797|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244798|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244799|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244800|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244801|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244802|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244803|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244804|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244805|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244806|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244807|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244808|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244809|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244810|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244811|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244812|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244813|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244814|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244815|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244816|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244817|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244818|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244819|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244820|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244821|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244822|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244823|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244824|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244825|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244826|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244827|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244828|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244829|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244830|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244831|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244832|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244833|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244834|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244835|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244836|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244837|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244838|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244839|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244840|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244841|NCT00106639|O1|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244842|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244843|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244844|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244845|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244846|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244847|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1245490|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1244848|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244849|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244850|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244851|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244852|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244853|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244854|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244855|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244856|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244857|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244858|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244859|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244860|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244861|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244862|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244863|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244864|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244865|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244866|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244867|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244868|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244869|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244870|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244871|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244872|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244873|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244874|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244875|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244876|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244877|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244878|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244879|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1244880|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244881|NCT00106639|E3|Reported Event|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
1244882|NCT00106639|E2|Reported Event|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
1245664|NCT00105586|E1|Reported Event|Placebo|Participants will receive a placebo.
1244883|NCT00106639|E1|Reported Event|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
1244884|NCT00106626|B5|Baseline|Total|Total of all reporting groups
1244885|NCT00106626|B4|Baseline|Cohort D - Vorinostat QD + Pemetrexed|"Dose level D.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed~Dose level D.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed"
1244886|NCT00106626|B3|Baseline|Cohort C - Vorinostat BID + Pemetrexed|"Dose level C.1 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed~Dose level C.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first two weeks, one week off + Pemetrexed~Dose level C.3 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days repeated weekly + Pemetrexed"
1244887|NCT00106626|B2|Baseline|Cohort B - Vorinostat QD + Pemetrexed + Cisplatin|"Dose level B.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin~Dose level B.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin"
1244888|NCT00106626|B1|Baseline|Cohort A - Vorinostat BID + Pemetrexed + Cisplatin|"Dose level A.1 - Vorinostat 200 mg twice daily (BID) for 14 days out of 3 weeks + Pemetrexed + Cisplatin~Dose level A.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed + Cisplatin"
1244889|NCT00106626|P4|Participant Flow|Cohort D - Vorinostat QD + Pemetrexed|"Dose level D.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed~Dose level D.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed"
1244890|NCT00106626|P3|Participant Flow|Cohort C - Vorinostat BID + Pemetrexed|"Dose level C.1 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed~Dose level C.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first two weeks, one week off + Pemetrexed~Dose level C.3 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days repeated weekly + Pemetrexed"
1244891|NCT00106626|P2|Participant Flow|Cohort B - Vorinostat QD + Pemetrexed + Cisplatin|"Dose level B.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin~Dose level B.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin"
1246106|NCT00104650|P3|Participant Flow|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
1244892|NCT00106626|P1|Participant Flow|Cohort A - Vorinostat BID + Pemetrexed + Cisplatin|"Dose level A.1 - Vorinostat 200 mg twice daily (BID) for 14 days out of 3 weeks + Pemetrexed + Cisplatin~Dose level A.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed + Cisplatin"
1244893|NCT00106626|O4|Outcome|Cohort D - Vorinostat QD + Pemetrexed|"Dose level D.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed~Dose level D.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed"
1244894|NCT00106626|O3|Outcome|Cohort C - Vorinostat BID + Pemetrexed|"Dose level C.1 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed~Dose level C.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first two weeks, one week off + Pemetrexed~Dose level C.3 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days repeated weekly + Pemetrexed"
1244895|NCT00106626|O2|Outcome|Cohort B - Vorinostat QD + Pemetrexed + Cisplatin|"Dose level B.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin~Dose level B.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin"
1244896|NCT00106626|O1|Outcome|Cohort A - Vorinostat BID + Pemetrexed + Cisplatin|"Dose level A.1 - Vorinostat 200 mg twice daily (BID) for 14 days out of 3 weeks + Pemetrexed + Cisplatin~Dose level A.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed + Cisplatin"
1244897|NCT00106626|O9|Outcome|Dose Level D.2|(Cohort D) Dose level D.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed
1244898|NCT00106626|O8|Outcome|Dose Level D.1|(Cohort D) Dose level D.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed
1244899|NCT00106626|O7|Outcome|Dose Level C.3|(Cohort C) Dose level C.3 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days repeated weekly + Pemetrexed
1244900|NCT00106626|O6|Outcome|Dose Level C.2|(Cohort C) Dose level C.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first two weeks, one week off + Pemetrexed
1244901|NCT00106626|O5|Outcome|Dose Level C.1|(Cohort C) Dose level C.1 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed
1244902|NCT00106626|O4|Outcome|Dose Level B.2|(Cohort B) Dose level B.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin
1244903|NCT00106626|O3|Outcome|Dose Level B.1|(Cohort B) Dose level B.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin
1244904|NCT00106626|O2|Outcome|Dose Level A.2|(Cohort A) Dose level A.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed + Cisplatin
1244905|NCT00106626|O1|Outcome|Dose Level A.1|(Cohort A) Dose level A.1 - Vorinostat 200 mg twice daily (BID) for 14 days out of 3 weeks + Pemetrexed + Cisplatin
1244906|NCT00106535|B4|Baseline|Total|Total of all reporting groups
1244907|NCT00106535|B3|Baseline|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244908|NCT00106535|B2|Baseline|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244909|NCT00106535|B1|Baseline|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1244910|NCT00106535|P4|Participant Flow|All Tocilizumab Exposure + MTX|All tocilizumab (TCZ) exposure + methotrexate (MTX) group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either Placebo, Tocilizumab 4 mg/kg or Tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received 8 mg/kg IV every 4 weeks.
1244953|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244954|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244955|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1244911|NCT00106535|P3|Participant Flow|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly for 52 weeks. From Week 16 participants with < 20% improvement in swollen and tender joints counts were eligible for escape therapy with tocilizumab. After Week 52 participants were able to switch to open label treatment with tocilizumab 8 mg/kg every 4 weeks for 12 months in year 2 (except patients who had a >70% improvement in both swollen and tender joint counts who remained on blinded treatment). Participants who completed year 2 of the study were eligible to enter an optional open-label long-term extension period (Year 3 to 5) and received Tocilizumab 8 mg/kg every 4 weeks.
1244912|NCT00106535|P2|Participant Flow|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab (TCZ) 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly for 52 weeks. From Week 16 participants with < 20% improvement in swollen and tender joints counts were eligible for escape therapy with tocilizumab. After Week 52 participants were able to switch to open label treatment with tocilizumab 8 mg/kg every 4 weeks for 12 months in year 2 (except patients who had a >70% improvement in both swollen and tender joint counts who remained on blinded treatment). Participants who completed year 2 of the study were eligible to enter an optional open-label long-term extension (LTE) period (Year 3 to 5) and received Tocilizumab 8 mg/kg every 4 weeks.
1244913|NCT00106535|P1|Participant Flow|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly for 52 weeks. From Week 16 participants with < 20% improvement in swollen and tender joints counts were eligible for escape therapy with tocilizumab. After Week 52 participants were able to switch to open label treatment with tocilizumab 8 mg/kg every 4 weeks for 12 months in year 2 (except patients who had a >70% improvement in both swollen and tender joint counts who remained on blinded treatment). Participants who completed year 2 of the study were eligible to enter an optional open-label long-term extension period (Year 3 to 5) and received Tocilizumab 8 mg/kg every 4 weeks.
1244914|NCT00106535|O2|Outcome|Tocilizumab + Methotrexate|All participants received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
1244915|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
1244973|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1244916|NCT00106535|O2|Outcome|Tocilizumab + Methotrexate|All participants received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
1244917|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
1244918|NCT00106535|O2|Outcome|Tocilizumab + Methotrexate|All participants received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
1244919|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
1244920|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
1244921|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
1244922|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
1244923|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
1244924|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
1244956|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245665|NCT00105534|B3|Baseline|Total|Total of all reporting groups
1244925|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
1244926|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
1244927|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
1244928|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
1244929|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
1244930|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
1244974|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1246237|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
1244931|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
1244932|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244933|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244934|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1244935|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244936|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244937|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1244938|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244939|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244940|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1244941|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244942|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244943|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1244944|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244945|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244946|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1244947|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244948|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244949|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1244950|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244951|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244952|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245747|NCT00105196|B3|Baseline|Total|Total of all reporting groups
1244957|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244958|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1244959|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244960|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244961|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1244962|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244963|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244964|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1244965|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244966|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244967|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1244968|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244969|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244970|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1244971|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244972|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1246238|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
1244975|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244976|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1244977|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244978|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244979|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1244980|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244981|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244982|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1244983|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244984|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244985|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1244986|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244987|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244988|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1244989|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244990|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244991|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1244992|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244993|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244994|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1244995|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244996|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244997|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1244998|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1244999|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245000|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245001|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245002|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245003|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245004|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245005|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245006|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245007|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245008|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245009|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245010|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245011|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245012|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245013|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245014|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245015|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245016|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245017|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245018|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1260668|NCT00041392|E1|Reported Event|Magnesium|100 mg/kg magnesium
1245019|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245020|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245021|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245022|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245023|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245024|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245025|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245026|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245027|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245028|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245029|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245030|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245031|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245032|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245033|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245034|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245035|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245036|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245037|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245038|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245039|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245040|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245041|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245042|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245043|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245044|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245045|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245046|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245047|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245048|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245049|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245050|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245051|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245052|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245053|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245054|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245055|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245056|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245057|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245058|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245059|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245060|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245061|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245062|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1246239|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
1245063|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245064|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245065|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245066|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245067|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245068|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245069|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245070|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245071|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245072|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245073|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245074|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245075|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245076|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245077|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245078|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245079|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245080|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245081|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245082|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245083|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245084|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245085|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245086|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245087|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245088|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245089|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245090|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245091|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245092|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245093|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245094|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245095|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245096|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245097|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245098|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245099|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245100|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245101|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245102|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245103|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245104|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245105|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245106|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1246240|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
1245107|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245108|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245109|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245110|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245111|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245112|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245113|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245114|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245115|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245116|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245117|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245118|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245119|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245120|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245121|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245122|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245123|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245124|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245125|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245126|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245127|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245128|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245129|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245130|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245131|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245132|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245133|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245134|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245135|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245136|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245137|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245138|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245139|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245140|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245141|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245142|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245143|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245144|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245145|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245146|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245147|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245148|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245149|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245150|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1260724|NCT00040937|E1|Reported Event|Induction/PBSC Mobilization|
1245151|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245152|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245153|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245154|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245155|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245156|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245157|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245158|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245159|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245160|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245161|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245162|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245163|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245164|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245165|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly
1245166|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245167|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245168|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly
1245169|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245170|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245171|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245172|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245173|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245174|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245175|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245176|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245177|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245178|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245179|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245180|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245181|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245182|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245183|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245184|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245185|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245186|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245187|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245188|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245189|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245190|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245191|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245192|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245193|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245194|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1246241|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
1245195|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245196|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245197|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245198|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245199|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245200|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
1245201|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
1245202|NCT00106535|E3|Reported Event|All Tocilizumab 8 mg/kg + Methotrexate|"All participants who received tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly during the study.~Total exposure TCZ 8mg + MTX = 3797.94 PY."
1245203|NCT00106535|E2|Reported Event|All Tocilizumab 4 mg/kg + Methotrexate|"All participants who received tocilizumab (TCZ) 4 mg/kg IV every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly during the study.~Total exposure TCZ 4mg + MTX = 580.99 PY."
1245204|NCT00106535|E1|Reported Event|Placebo + Methotrexate|"Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.~Total Exposure Placebo + MTX = 282.36 patient-years (PY)."
1245205|NCT00106431|B1|Baseline|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
1245206|NCT00106431|P1|Participant Flow|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
1245207|NCT00106431|O1|Outcome|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
1245208|NCT00106431|O1|Outcome|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
1245209|NCT00106431|O1|Outcome|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
1245210|NCT00106431|O1|Outcome|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
1245211|NCT00106431|O1|Outcome|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
1245785|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
1245212|NCT00106431|O1|Outcome|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
1245213|NCT00106431|O1|Outcome|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
1245214|NCT00106431|E1|Reported Event|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
1245215|NCT00106392|B3|Baseline|Total|Total of all reporting groups
1245216|NCT00106392|B2|Baseline|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
1245217|NCT00106392|B1|Baseline|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
1245218|NCT00106392|P2|Participant Flow|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
1245219|NCT00106392|P1|Participant Flow|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
1245220|NCT00106392|O2|Outcome|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
1245221|NCT00106392|O1|Outcome|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
1245440|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245222|NCT00106392|O2|Outcome|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
1245223|NCT00106392|O1|Outcome|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
1245224|NCT00106392|O2|Outcome|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
1245225|NCT00106392|O1|Outcome|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
1245226|NCT00106392|O2|Outcome|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
1245227|NCT00106392|O1|Outcome|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
1245228|NCT00106392|O2|Outcome|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
1245229|NCT00106392|O1|Outcome|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
1245230|NCT00106392|O2|Outcome|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
1245231|NCT00106392|O1|Outcome|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
1245232|NCT00106392|E2|Reported Event|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
1245233|NCT00106392|E1|Reported Event|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
1245234|NCT00106353|B3|Baseline|Total|Total of all reporting groups
1245235|NCT00106353|B2|Baseline|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245236|NCT00106353|B1|Baseline|Part 1|Participants received temsirolimus intravenously once weekly over 60 minutes infusion in dose escalation schemes of 10 mg/m^2, 25 mg/m^2, 75 mg/m^2 and 150 mg/m^2.
1245237|NCT00106353|P7|Participant Flow|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245238|NCT00106353|P6|Participant Flow|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245239|NCT00106353|P5|Participant Flow|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245240|NCT00106353|P4|Participant Flow|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245786|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
1245241|NCT00106353|P3|Participant Flow|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245242|NCT00106353|P2|Participant Flow|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245243|NCT00106353|P1|Participant Flow|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligram per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
1245244|NCT00106353|O2|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245245|NCT00106353|O1|Outcome|Part 1|Participants received temsirolimus intravenously once weekly over 60 minutes infusion in dose escalation schemes of 10 mg/m^2, 25 mg/m^2, 75 mg/m^2 and 150 mg/m^2.
1245246|NCT00106353|O2|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245247|NCT00106353|O1|Outcome|Part 1|Participants received temsirolimus intravenously once weekly over 60 minutes infusion in dose escalation schemes of 10 mg/m^2, 25 mg/m^2, 75 mg/m^2 and 150 mg/m^2.
1245248|NCT00106353|O1|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245249|NCT00106353|O1|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245250|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245251|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245252|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245253|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 intravenously administered once weekly over 60 minutes infusion.
1245254|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245255|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1246242|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
1245256|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
1245257|NCT00106353|O1|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245258|NCT00106353|O1|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245259|NCT00106353|O1|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245260|NCT00106353|O1|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245261|NCT00106353|O1|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion..
1245262|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245263|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245264|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245265|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245266|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245267|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245268|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245269|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245270|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245271|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
1245272|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245273|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245274|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245275|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
1245276|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245277|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245278|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245279|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
1245280|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245281|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245282|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245283|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
1245284|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245285|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245286|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245287|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
1245288|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245289|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245290|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245291|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
1245292|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 intravenously administered once weekly over 60 minutes infusion.
1245293|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245294|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245295|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
1245296|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245297|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245298|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245299|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245300|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245301|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245302|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245303|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245304|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245305|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245306|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245307|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245308|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245309|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245310|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245311|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245312|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245313|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245314|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245315|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245316|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245317|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245318|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245319|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245787|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
1245320|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245321|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245322|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245323|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
1245324|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245325|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245326|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245327|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
1245328|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245329|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245330|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245331|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
1245332|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245333|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245334|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245335|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
1245336|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1246243|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
1245337|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245338|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245339|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
1245340|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245341|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245342|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245343|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
1245344|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245345|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245346|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245347|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
1245348|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245349|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245350|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245351|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
1245352|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245353|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245354|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245355|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
1245356|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245357|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245358|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245359|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
1245360|NCT00106353|E7|Reported Event|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245361|NCT00106353|E6|Reported Event|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245567|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
1245362|NCT00106353|E5|Reported Event|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
1245363|NCT00106353|E4|Reported Event|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 intravenously administered once weekly over 60 minutes infusion.
1245364|NCT00106353|E3|Reported Event|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 intravenously administered once weekly over 60 minutes infusion.
1245365|NCT00106353|E2|Reported Event|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 intravenously administered once weekly over 60 minutes infusion.
1245366|NCT00106353|E1|Reported Event|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
1245367|NCT00106249|B3|Baseline|Total|Total of all reporting groups
1245368|NCT00106249|B2|Baseline|Sham rTMS|"Placebo Repetitive Transcranial Magnetic Stimulation (rTMS)~Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation."
1245369|NCT00106249|B1|Baseline|Active rTMS|"Active Repetitive Transcranial Magnetic Stimulation (rTMS)~Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator."
1245370|NCT00106249|P2|Participant Flow|Sham rTMS|"Placebo Repetitive Transcranial Magnetic Stimulation (rTMS)~Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation."
1245371|NCT00106249|P1|Participant Flow|Active rTMS|"Active Repetitive Transcranial Magnetic Stimulation (rTMS)~Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator."
1245372|NCT00106249|O2|Outcome|Sham rTMS|"Placebo Repetitive Transcranial Magnetic Stimulation (rTMS)~Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation."
1246408|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
1245373|NCT00106249|O1|Outcome|Active rTMS|"Active Repetitive Transcranial Magnetic Stimulation (rTMS)~Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator."
1245374|NCT00106249|O2|Outcome|Sham rTMS|"Placebo Repetitive Transcranial Magnetic Stimulation (rTMS)~Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation."
1245375|NCT00106249|O1|Outcome|Active rTMS|"Active Repetitive Transcranial Magnetic Stimulation (rTMS)~Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator."
1245376|NCT00106249|O2|Outcome|Sham rTMS|"Placebo Repetitive Transcranial Magnetic Stimulation (rTMS)~Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation."
1245377|NCT00106249|O1|Outcome|Active rTMS|"Active Repetitive Transcranial Magnetic Stimulation (rTMS)~Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator."
1245378|NCT00106249|E2|Reported Event|Sham rTMS|"Placebo Repetitive Transcranial Magnetic Stimulation (rTMS)~Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation."
1245379|NCT00106249|E1|Reported Event|Active rTMS|"Active Repetitive Transcranial Magnetic Stimulation (rTMS)~Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator."
1245380|NCT00106184|B3|Baseline|Total|Total of all reporting groups
1245381|NCT00106184|B2|Baseline|Group B|"Subjects received placebo at Weeks 0 and 1 followed by rituximab at Weeks 8 and 9 (Treatment Group B)~Group B - intravenous rituximab 750mg/m2 BSA up to a maximum does of 1 gram at Weeks 8 and 9~Treatment Group B: placebo infusion at Weeks 0 and 1"
1245382|NCT00106184|B1|Baseline|Group A|"Subjects received rituximab at Weeks 0 and 1 followed by placebo at Weeks 8 and 9 (Treatment Group A)~Rituximab : Treatment Group A - intravenous rituximab 750mg/m2 BSA up to a maximum dose of 1 gram at Weeks 0 and 1~Placebo : Treatment Group A: placebo infusion at Weeks 8 and 9"
1245383|NCT00106184|P2|Participant Flow|Treatment Group B (Rituximab Wks 8 and 9)|"Subjects received placebo at Weeks 0 and 1 followed by rituximab at Weeks 8 and 9 (Treatment Group B)~Group B - intravenous rituximab 750mg/m2 BSA up to a maximum does of 1 gram at Weeks 8 and 9~Treatment Group B: placebo infusion at Weeks 0 and 1"
1245384|NCT00106184|P1|Participant Flow|Treatment Group A (Rituximab Wks 0 and 1)|"Subjects received rituximab at Weeks 0 and 1 followed by placebo at Weeks 8 and 9 (Treatment Group A)~Rituximab : Treatment Group A - intravenous rituximab 750mg/m2 BSA (Body Surface Area) up to a maximum dose of 1 gram at Weeks 0 and 1 Placebo : Treatment Group A: placebo infusion at Weeks 8 and 9"
1245467|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245385|NCT00106184|O2|Outcome|Treatment Group B (Rituximab Wks 8 and 9)|"Subjects received placebo at Weeks 0 and 1 followed by rituximab at Weeks 8 and 9 (Treatment Group B)~Group B - intravenous rituximab 750mg/m2 BSA up to a maximum does of 1 gram at Weeks 8 and 9~Treatment Group B: placebo infusion at Weeks 0 and 1"
1245386|NCT00106184|O1|Outcome|Treatment Group A (Rituximab Wks 0 and 1)|"Subjects received rituximab at Weeks 0 and 1 followed by placebo at Weeks 8 and 9 (Treatment Group A)~Rituximab : Treatment Group A - intravenous rituximab 750mg/m2 BSA up to a maximum dose of 1 gram at Weeks 0 and 1 Placebo : Treatment Group A: placebo infusion at Weeks 8 and 9"
1245387|NCT00106184|O2|Outcome|Treatment Group B (Rituximab Wks 8 and 9)|"Subjects received placebo at Weeks 0 and 1 followed by rituximab at Weeks 8 and 9 (Treatment Group B)~Group B - intravenous rituximab 750mg/m2 BSA up to a maximum does of 1 gram at Weeks 8 and 9~Treatment Group B: placebo infusion at Weeks 0 and 1"
1245388|NCT00106184|O1|Outcome|Treatment Group A (Rituximab Wks 0 and 1)|"Subjects received rituximab at Weeks 0 and 1 followed by placebo at Weeks 8 and 9 (Treatment Group A)~Rituximab : Treatment Group A - intravenous rituximab 750mg/m2 BSA up to a maximum dose of 1 gram at Weeks 0 and 1 Placebo : Treatment Group A: placebo infusion at Weeks 8 and 9"
1245389|NCT00106184|O2|Outcome|Group B (Rituximab Wks 8 and 9)|"Group B - intravenous rituximab 750mg/m2 BSA up to a maximum does of 1 gram at Weeks 8 and 9~Treatment Group B: placebo infusion at Weeks 0 and 1"
1245390|NCT00106184|O1|Outcome|Group A (Rituximab Wks 0 and 1)|"Subjects received rituximab at Weeks 0 and 1 followed by placebo at Weeks 8 and 9 (Treatment Group A)~Rituximab : Treatment Group A - intravenous rituximab 750mg/m2 BSA up to a maximum dose of 1 gram at Weeks 0 and 1~Placebo : Treatment Group A: placebo infusion at Weeks 8 and 9"
1245391|NCT00106184|E2|Reported Event|Treatment Group B|"Subjects received placebo at Weeks 0 and 1 followed by rituximab at Weeks 8 and 9 (Treatment Group B)~Group B - intravenous rituximab 750mg/m2 BSA up to a maximum does of 1 gram at Weeks 8 and 9~Treatment Group B: placebo infusion at Weeks 0 and 1"
1245392|NCT00106184|E1|Reported Event|Treatment Group A|"Subjects received rituximab at Weeks 0 and 1 followed by placebo at Weeks 8 and 9 (Treatment Group A)~Rituximab : Treatment Group A - intravenous rituximab 750mg/m2 BSA up to a maximum dose of 1 gram at Weeks 0 and 1 Placebo : Treatment Group A: placebo infusion at Weeks 8 and 9"
1245393|NCT00106119|B1|Baseline|Entire Study Population|Includes groups randomized to receive Levothyroxine first and Liothyronine first.
1245394|NCT00106119|P2|Participant Flow|Levothyroxine First, Then Liothyronine|Levothyroxine (dose of 5, 10, or 33 mcg) in first intervention period and Liothyronine (dose of 2.5, 10, or 16 mcg) in second intervention period (after washout period)
1245395|NCT00106119|P1|Participant Flow|Liothyronine First, Then Levothyroxine|Liothyronine (dose of 2.5, 10, or 16 mcg) in first intervention period and Levothyroxine (dose of 5, 10, or 33 mcg) in second intervention period (after washout period)
1246409|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
1245396|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
1245397|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
1245398|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
1245399|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
1245400|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
1245401|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
1245402|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention ArmArm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
1245403|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
1245404|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
1245405|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
1245406|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
1245407|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
1245408|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
1245409|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
1245410|NCT00106119|E2|Reported Event|Liothyronine Period|Patients at Liothyronine Period
1245411|NCT00106119|E1|Reported Event|Levothyroxine Period|Patients at Levothyroxine Period
1245412|NCT00106106|B3|Baseline|Total|Total of all reporting groups
1245413|NCT00106106|B2|Baseline|Acamprosate|For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.
1245414|NCT00106106|B1|Baseline|Placebo|For subjects randomized to placebo control, placebo doses were given every 8 hours.
1245415|NCT00106106|P2|Participant Flow|Acamprosate|For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.
1245416|NCT00106106|P1|Participant Flow|Placebo|For subjects randomized to placebo control, placebo doses were given every 8 hours.
1245468|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245663|NCT00105586|E2|Reported Event|Escitalopram|Participants will receive escitalopram.
1245417|NCT00106106|O2|Outcome|Acamprosate|For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.
1245418|NCT00106106|O1|Outcome|Placebo|For subjects randomized to placebo control, placebo doses were given every 8 hours.
1245419|NCT00106106|O2|Outcome|Acamprosate|For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.
1245420|NCT00106106|O1|Outcome|Placebo|For subjects randomized to placebo control, placebo doses were given every 8 hours.
1245421|NCT00106106|E2|Reported Event|Acamprosate|For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.
1245422|NCT00106106|E1|Reported Event|Placebo|For subjects randomized to placebo control, placebo doses were given every 8 hours.
1245423|NCT00106080|B3|Baseline|Total|Total of all reporting groups
1245424|NCT00106080|B2|Baseline|Control|Usual care
1245425|NCT00106080|B1|Baseline|Intervention|Audit and feedback
1245426|NCT00106080|P2|Participant Flow|Control (Usual Care)|We solicited control patients' preferences but did not deliver study generated summary reports to patients, surrogates or providers.
1245427|NCT00106080|P1|Participant Flow|Intervention (Audit and Feedback)|We solicited patients' preferences for health care communication and treatment in order to generate individualized summary reports of patient's preferences. These individualized summaries of patient's preferences regarding communication about end-of-life care and preferences for end-of-life care were used to activate patients, family members, and healthcare providers.
1245428|NCT00106080|O2|Outcome|Control|Usual care
1245429|NCT00106080|O1|Outcome|Intervention|Audit and Feedback
1245430|NCT00106080|O2|Outcome|Control|Usual care
1245431|NCT00106080|O1|Outcome|Intervention|Audit and Feedback
1245432|NCT00106080|E2|Reported Event|Control|Usual care
1245433|NCT00106080|E1|Reported Event|Intervention|Audit and Feedback
1245434|NCT00106028|B3|Baseline|Total|Total of all reporting groups
1245435|NCT00106028|B2|Baseline|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245436|NCT00106028|B1|Baseline|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245437|NCT00106028|P2|Participant Flow|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245438|NCT00106028|P1|Participant Flow|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245439|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245441|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245442|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245443|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245444|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245445|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245446|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245447|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245448|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245449|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245450|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245451|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245452|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245453|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245454|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245455|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245456|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245457|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245458|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245459|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245460|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245461|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245462|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245463|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245464|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245465|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245466|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245469|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245470|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245471|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245472|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245473|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245474|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245475|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245476|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245477|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245478|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245479|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245480|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245481|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245482|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245483|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245484|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245485|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245486|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245487|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245488|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245489|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1246410|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
1245491|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245492|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245493|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245494|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245495|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245496|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245497|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245498|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245499|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245500|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245501|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245502|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245503|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245504|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245505|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245506|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245507|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245508|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245509|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245510|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245511|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245512|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245513|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245514|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245515|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245516|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245517|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245518|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245519|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245520|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245521|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245522|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245523|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245524|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245525|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245526|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245527|NCT00106028|E4|Reported Event|Years 2 & 3 Risedronate|Years 1-3 Risedronate, Double-Blind Year 1, Open-Label Years 2 & 3
1245528|NCT00106028|E3|Reported Event|Years 2 & 3 Placebo-Risedronate|Year 1 Placebo Double-Blind, Years 2 & 3 Open-Label Risedronate
1245529|NCT00106028|E2|Reported Event|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
1245530|NCT00106028|E1|Reported Event|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
1245531|NCT00106002|B1|Baseline|Pemetrexed|600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
1245532|NCT00106002|P1|Participant Flow|Pemetrexed|600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
1245533|NCT00106002|O1|Outcome|Pemetrexed|600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
1245534|NCT00106002|O1|Outcome|Pemetrexed|600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
1245535|NCT00106002|O1|Outcome|Pemetrexed|600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
1245536|NCT00106002|O1|Outcome|Pemetrexed|600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
1245537|NCT00106002|O1|Outcome|Pemetrexed|600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
1245538|NCT00106002|E1|Reported Event|Pemetrexed|Pemetrexed
1245539|NCT00105989|B1|Baseline|Duloxetine|duloxetine 60-120 mg QD
1245540|NCT00105989|P2|Participant Flow|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
1246411|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
1245541|NCT00105989|P1|Participant Flow|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
1245542|NCT00105989|O3|Outcome|Duloxetine 120 mg|duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
1245543|NCT00105989|O2|Outcome|Duloxetine 90 mg|duloxetine 90 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
1245544|NCT00105989|O1|Outcome|Duloxetine 60 mg|duloxetine 60 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
1245545|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
1245546|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
1245547|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
1245548|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
1245549|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
1245550|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
1245551|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
1245552|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
1245553|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
1245554|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
1245555|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
1245556|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
1245557|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
1245558|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
1245559|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
1245560|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
1245561|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
1245562|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
1245563|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
1245564|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
1245565|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
1245566|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
1245568|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
1245569|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
1245570|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
1245571|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
1245572|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
1245573|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
1245574|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
1245575|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
1245576|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
1245577|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
1245578|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
1245579|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
1245580|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
1245581|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
1245582|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
1245583|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
1245584|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
1245585|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
1245586|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
1245587|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
1245588|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
1245589|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
1245590|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
1245591|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
1245592|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
1245593|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
1245594|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
1245595|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
1245596|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
1245597|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
1245598|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
1245599|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
1245600|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg QD
1245601|NCT00105989|O1|Outcome|Duloxetine - Acute|duloxetine 60-120 mg QD
1245602|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
1245603|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
1245604|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
1245605|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
1245606|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
1245607|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
1245608|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
1245609|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
1245610|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
1245611|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
1245612|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
1245613|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
1245614|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
1245615|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
1245616|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
1245617|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
1245618|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
1245619|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
1245620|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
1245621|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
1245622|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
1245623|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
1245624|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
1245625|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
1245626|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
1245627|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
1245628|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
1245629|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
1245630|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
1245631|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
1245632|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
1245633|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
1246412|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
1245634|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
1245635|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
1245636|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
1245637|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
1245638|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
1245639|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
1245640|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
1245641|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
1245642|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
1245643|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
1245644|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
1245645|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
1245646|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
1245647|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
1245648|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
1245649|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
1245650|NCT00105989|E4|Reported Event|Duloxetine 120 mg|Duloxetine 120 mg
1245651|NCT00105989|E3|Reported Event|Duloxetine 90 mg|Duloxetine 90 mg
1245652|NCT00105989|E2|Reported Event|Duloxetine 60 mg|Duloxetine 60 mg
1245653|NCT00105989|E1|Reported Event|Placebo|Placebo
1245654|NCT00105586|B3|Baseline|Total|Total of all reporting groups
1245655|NCT00105586|B2|Baseline|Escitalopram|Participants will receive escitalopram.
1245656|NCT00105586|B1|Baseline|Placebo|Participants will receive a placebo.
1245657|NCT00105586|P2|Participant Flow|Escitalopram|Participants will receive escitalopram.
1245658|NCT00105586|P1|Participant Flow|Placebo|Participants will receive a placebo.
1245659|NCT00105586|O2|Outcome|Placebo (2)|"Placebo~Escitalopram: Participants will either take 10 to 20 mg of escitalopram or placebo. Participants who wish to participate in the open-label extension receive an additional 12 weeks of escitalopram."
1245660|NCT00105586|O1|Outcome|Escitalopram (1)|"Escitalopram~Escitalopram: Participants will either take 10 to 20 mg of escitalopram or placebo. Participants who wish to participate in the open-label extension receive an additional 12 weeks of escitalopram."
1245661|NCT00105586|O2|Outcome|Escitalopram|Participants will receive escitalopram.
1245662|NCT00105586|O1|Outcome|Placebo|Participants will receive a placebo.
1245666|NCT00105534|B2|Baseline|Vehicle|Per protocol population defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment.
1245667|NCT00105534|B1|Baseline|AzaSite|Per protocol population defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment.
1245668|NCT00105534|P2|Participant Flow|Vehicle|
1245669|NCT00105534|P1|Participant Flow|AzaSite|
1245670|NCT00105534|O2|Outcome|Vehicle|
1245671|NCT00105534|O1|Outcome|AzaSite|
1245672|NCT00105534|O2|Outcome|Vehicle|
1245673|NCT00105534|O1|Outcome|AzaSite|
1245674|NCT00105534|E2|Reported Event|Vehicle|
1245675|NCT00105534|E1|Reported Event|AzaSite|
1245676|NCT00105482|B3|Baseline|Total|Total of all reporting groups
1245677|NCT00105482|B2|Baseline|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
1245678|NCT00105482|B1|Baseline|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day~Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day~Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
1245679|NCT00105482|P2|Participant Flow|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
1245680|NCT00105482|P1|Participant Flow|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day~Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day~Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
1245681|NCT00105482|O2|Outcome|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
1245682|NCT00105482|O1|Outcome|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day~Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day~Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
1245683|NCT00105482|O2|Outcome|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
1245684|NCT00105482|O1|Outcome|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day~Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day~Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
1245685|NCT00105482|O2|Outcome|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
1245686|NCT00105482|O1|Outcome|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day~Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day~Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
1245687|NCT00105482|O2|Outcome|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
1245688|NCT00105482|O1|Outcome|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day~Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day~Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
1245689|NCT00105482|O2|Outcome|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
1245690|NCT00105482|O1|Outcome|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day~Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day~Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
1245691|NCT00105482|E2|Reported Event|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
1245718|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
1246111|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
1245692|NCT00105482|E1|Reported Event|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day~Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day~Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
1245693|NCT00105469|B3|Baseline|Total|Total of all reporting groups
1245694|NCT00105469|B2|Baseline|Tobramycin|"Per protocol population (defined as all randomized~subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of~pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward."
1245695|NCT00105469|B1|Baseline|AzaSite|"Per protocol population (defined as all randomized~subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of~pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward."
1245696|NCT00105469|P2|Participant Flow|Tobramycin|
1245697|NCT00105469|P1|Participant Flow|AzaSite|
1245698|NCT00105469|O2|Outcome|Tobramycin|
1245699|NCT00105469|O1|Outcome|AzaSite|
1245700|NCT00105469|O2|Outcome|Tobramycin|
1245701|NCT00105469|O1|Outcome|AzaSite|
1245702|NCT00105469|E2|Reported Event|Tobramycin|
1245703|NCT00105469|E1|Reported Event|AzaSite|
1245704|NCT00105443|B3|Baseline|Total|Total of all reporting groups
1245705|NCT00105443|B2|Baseline|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
1245706|NCT00105443|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
1245707|NCT00105443|P4|Participant Flow|B2) Placebo First - Then Open Label Sorafenib Treatment Phase|"Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.~Note: Safety Data of participants in the arm presented here are reported in Reporting Groups (RG) RG2, RG4, and RG5 in the Safety section."
1245708|NCT00105443|P3|Participant Flow|B1) Placebo - no Open Label Phase|"Sorafenib-matching placebo tablets were orally administered twice daily (bid).~Note: Safety Data of participants in the arm presented here are reported in Reporting Groups (RG) RG2 and RG4 in the Safety section."
1245709|NCT00105443|P2|Participant Flow|A2) Sorafenib (Nexavar, BAY43-9006) - With Open Label Phase|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study Note: Safety Data of participants in the arm presented here are reported in Reporting Groups (RG) RG1 and RG3 in the Safety section.
1245788|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
1245789|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
1245710|NCT00105443|P1|Participant Flow|A1) Sorafenib (Nexavar, BAY43-9006) - no Open Label Phase|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Note: Safety Data of participants in the arm presented here are reported in Reporting Groups (RG) RG1 and RG3 in the Safety section.
1245711|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
1245712|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
1245713|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
1245714|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
1245715|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
1245716|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
1245717|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
1246112|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
1245719|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
1245720|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
1245721|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
1245722|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
1245723|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
1245724|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
1245725|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
1245726|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
1245727|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
1245728|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
1245729|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
1245790|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
1245791|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
1245730|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
1245731|NCT00105443|E5|Reported Event|Subjects Switching From Placebo to Sorafenib (Open Label Only)|Reporting Group 5 (RG 5): Participants initially randomized to Placebo who switched to Sorafenib in Open Label phase (data after unblinding only, from Feb 09, 2007 until Nov 21, 2008); Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid). Note: Safety Data presented here include participants listed in Arm B2 of the Participant Flow section.
1245732|NCT00105443|E4|Reported Event|Placebo Arm, Complete Double-Blind Phase|"Reporting Group 4 (RG 4): All participants that initially were randomized to Placebo (data from Placebo patients before unblinding at Feb 09, 2007); Sorafenib-matching placebo tablets were orally administered twice daily (bid).~Note: Safety Data presented here include participants listed in Arms B1 and B2 of the Participant Flow section."
1245733|NCT00105443|E3|Reported Event|Sorafenib (Nexavar) Arm Complete (Incl. Open Label Phase)|Reporting Group 3 (RG 3): All participants that initially were randomized to Sorafenib treatment (data before unblinding (= Double-Blind phase) and after unblinding (= Open Label phase)), until Nov 21, 2008); Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Note: Safety Data presented here include participants listed in Arms A1 and A2 of the Participant Flow section.
1245734|NCT00105443|E2|Reported Event|Placebo Arm Double-Blind Phase (Interim Data Only)|"Reporting Group 2 (RG 2): All participants in Double-Blind phase randomized to Sorafenib-matching placebo (data before Oct 17, 2006); Sorafenib-matching placebo tablets were orally administered twice daily (bid).~Note: Safety Data presented here include participants listed in Arms B1 and B2 of the Participant Flow section."
1245735|NCT00105443|E1|Reported Event|Sorafenib (Nexavar) Arm Double-Blind Phase (Interim Data Only)|Reporting Group 1 (RG 1): All participants in Double-Blind phase randomized to Sorafenib treatment (data before Oct 17, 2006); Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Note: Safety Data presented here include participants listed in Arms A1 and A2 of the Participant Flow section.
1245759|NCT00105196|O1|Outcome|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
1246113|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
1245736|NCT00105235|B1|Baseline|Alemtuzumab|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
1245737|NCT00105235|P1|Participant Flow|Alemtuzumab|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
1245738|NCT00105235|O1|Outcome|Alemtuzumab|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
1245739|NCT00105235|O1|Outcome|Alemtuzumab|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
1245792|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
1245740|NCT00105235|O4|Outcome|Discontinued Immunosuppression Withdrawal|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
1245741|NCT00105235|O3|Outcome|Completed Withdrawal and Restarted Immunosuppression|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
1245742|NCT00105235|O2|Outcome|Completed Withdrawal and Remains Off Immunosuppression|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
1245760|NCT00105196|O2|Outcome|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
1245834|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245743|NCT00105235|O1|Outcome|Withdrawal Never Started|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
1245744|NCT00105235|O1|Outcome|Alemtuzumab|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
1245745|NCT00105235|O1|Outcome|Alemtuzumab|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
1245746|NCT00105235|E1|Reported Event|Alemtuzumab|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
1245748|NCT00105196|B2|Baseline|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
1245749|NCT00105196|B1|Baseline|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
1245750|NCT00105196|P2|Participant Flow|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
1245751|NCT00105196|P1|Participant Flow|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
1245752|NCT00105196|O2|Outcome|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
1245753|NCT00105196|O1|Outcome|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
1245754|NCT00105196|O2|Outcome|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
1245755|NCT00105196|O1|Outcome|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
1245756|NCT00105196|O2|Outcome|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
1245757|NCT00105196|O1|Outcome|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
1245758|NCT00105196|O2|Outcome|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
1246232|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
1245761|NCT00105196|O1|Outcome|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
1245762|NCT00105196|O2|Outcome|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
1245763|NCT00105196|O1|Outcome|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
1245764|NCT00105196|O2|Outcome|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
1245765|NCT00105196|O1|Outcome|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
1245766|NCT00105196|O2|Outcome|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
1245767|NCT00105196|O1|Outcome|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
1245768|NCT00105196|E2|Reported Event|Placebo|
1245769|NCT00105196|E1|Reported Event|Aripiprazole|
1245770|NCT00105183|B4|Baseline|Total|Total of all reporting groups
1245771|NCT00105183|B3|Baseline|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
1245772|NCT00105183|B2|Baseline|Placebo|USP 0.9% sodium chloride solution
1245773|NCT00105183|B1|Baseline|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
1245774|NCT00105183|P3|Participant Flow|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
1245775|NCT00105183|P2|Participant Flow|Placebo|USP 0.9% sodium chloride solution
1245776|NCT00105183|P1|Participant Flow|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
1245777|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
1245778|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
1245779|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
1245780|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
1245781|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
1245782|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
1245783|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
1245784|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
1245794|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
1245795|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
1245796|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
1245797|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
1245798|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
1245799|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
1245800|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
1245801|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
1245802|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
1245803|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
1245804|NCT00105183|E3|Reported Event|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
1245805|NCT00105183|E2|Reported Event|Placebo|USP 0.9% sodium chloride solution
1245806|NCT00105183|E1|Reported Event|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
1245807|NCT00105157|B5|Baseline|Total|Total of all reporting groups
1245808|NCT00105157|B4|Baseline|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245809|NCT00105157|B3|Baseline|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245810|NCT00105157|B2|Baseline|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1246107|NCT00104650|P2|Participant Flow|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
1245811|NCT00105157|B1|Baseline|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245812|NCT00105157|P4|Participant Flow|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245813|NCT00105157|P3|Participant Flow|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245814|NCT00105157|P2|Participant Flow|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245815|NCT00105157|P1|Participant Flow|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245816|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245817|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245818|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245819|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245820|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245821|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245822|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245823|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245824|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245825|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245826|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245827|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245828|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245829|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245830|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245831|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245832|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245833|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1246413|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
1245835|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245836|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245837|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245838|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245839|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245840|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245841|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245842|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245843|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245844|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245845|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245846|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245847|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245848|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245849|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245850|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245851|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245852|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245853|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245854|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245855|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245856|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245857|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1246108|NCT00104650|P1|Participant Flow|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
1245858|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245859|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245860|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245861|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245862|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245863|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245864|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245865|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245866|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245867|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245868|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245869|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245870|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245871|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245872|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1246147|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day.
1245873|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245874|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245875|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245876|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245877|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245878|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245879|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245880|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245950|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1246414|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
1245881|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245882|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245883|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245884|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245885|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245886|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245887|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245888|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245889|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245890|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245891|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245892|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245893|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245894|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245895|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245896|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245897|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245898|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245899|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245900|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245901|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245902|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245903|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245974|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1246415|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
1245904|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245905|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245906|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245907|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245908|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245909|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245910|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245911|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245912|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245913|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245914|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245915|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245916|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245917|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245918|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1246148|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
1245919|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245920|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245921|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245922|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245923|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245924|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245925|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245926|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245998|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1246109|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
1245927|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245928|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245929|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245930|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245931|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245932|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245933|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245934|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245935|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245936|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245937|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245938|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245939|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245940|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1246149|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day.
1245941|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245942|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245943|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245944|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245945|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245946|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245947|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245948|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245949|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1246035|NCT00105066|O1|Outcome|Placebo|Placebo : placebo tablet once a day for one month, then twice a day for 3 months
1245951|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245952|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245953|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245954|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245955|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245956|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245957|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245958|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245959|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245960|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245961|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245962|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245963|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245964|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245965|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245966|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245967|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245968|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245969|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245970|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245971|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245972|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245973|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1246036|NCT00105066|E2|Reported Event|Metformin|Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
1245975|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245976|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245977|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245978|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245979|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245980|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245981|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245982|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245983|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245984|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245985|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245986|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245987|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245988|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245989|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245990|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245991|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245992|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245993|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245994|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1245995|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245996|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1245997|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1246037|NCT00105066|E1|Reported Event|Placebo|Placebo : placebo tablet once a day for one month, then twice a day for 3 months
1245999|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1246000|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1246001|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1246002|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
1246003|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1246004|NCT00105157|E2|Reported Event|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
1246005|NCT00105157|E1|Reported Event|MK0518|Includes patients from the MK0518 200 mg, 400 mg, and 600 mg b.i.d. dose groups. Patients who completed at least 24 weeks of double-blind therapy without virologic failure entered the open-label phase to receive open-label MK0518 400 mg b.i.d.
1246006|NCT00105079|B3|Baseline|Total|Total of all reporting groups
1246007|NCT00105079|B2|Baseline|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
1246008|NCT00105079|B1|Baseline|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
1246009|NCT00105079|P2|Participant Flow|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
1246010|NCT00105079|P1|Participant Flow|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
1246011|NCT00105079|O2|Outcome|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
1246012|NCT00105079|O1|Outcome|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
1246013|NCT00105079|O2|Outcome|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
1246014|NCT00105079|O1|Outcome|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
1246015|NCT00105079|O2|Outcome|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
1246016|NCT00105079|O1|Outcome|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
1246017|NCT00105079|O2|Outcome|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
1246018|NCT00105079|O1|Outcome|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
1246019|NCT00105079|O2|Outcome|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
1246020|NCT00105079|O1|Outcome|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
1246021|NCT00105079|O2|Outcome|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
1246022|NCT00105079|O1|Outcome|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
1246023|NCT00105079|E2|Reported Event|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
1246024|NCT00105079|E1|Reported Event|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
1246025|NCT00105066|B3|Baseline|Total|Total of all reporting groups
1246026|NCT00105066|B2|Baseline|Metformin|Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
1246027|NCT00105066|B1|Baseline|Placebo|Placebo : placebo tablet once a day for one month, then twice a day for 3 months
1246028|NCT00105066|P2|Participant Flow|Metformin|Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
1246029|NCT00105066|P1|Participant Flow|Placebo|Placebo : placebo tablet once a day for one month, then twice a day for 3 months
1246030|NCT00105066|O2|Outcome|Metformin|Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
1246031|NCT00105066|O1|Outcome|Placebo|Placebo : placebo tablet once a day for one month, then twice a day for 3 months
1246032|NCT00105066|O2|Outcome|Metformin|Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
1246033|NCT00105066|O1|Outcome|Placebo|Placebo : placebo tablet once a day for one month, then twice a day for 3 months
1246034|NCT00105066|O2|Outcome|Metformin|Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
1246038|NCT00105027|B7|Baseline|Total|Total of all reporting groups
1246039|NCT00105027|B6|Baseline|BRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
1246040|NCT00105027|B5|Baseline|BRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
1246041|NCT00105027|B4|Baseline|BRVO Standard Care|Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
1246042|NCT00105027|B3|Baseline|CRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
1246043|NCT00105027|B2|Baseline|CRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
1246044|NCT00105027|B1|Baseline|CRVO Observation|Standard care consists of observation of the macular edema.
1246045|NCT00105027|P6|Participant Flow|BRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
1246046|NCT00105027|P5|Participant Flow|BRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
1246047|NCT00105027|P4|Participant Flow|BRVO Standard Care|Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
1246048|NCT00105027|P3|Participant Flow|CRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
1246049|NCT00105027|P2|Participant Flow|CRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
1246050|NCT00105027|P1|Participant Flow|CRVO Observation|Standard care consists of observation of the macular edema.
1246051|NCT00105027|O6|Outcome|BRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
1246052|NCT00105027|O5|Outcome|BRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
1246053|NCT00105027|O4|Outcome|BRVO Standard Care|Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
1246054|NCT00105027|O3|Outcome|CRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
1246055|NCT00105027|O2|Outcome|CRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
1246056|NCT00105027|O1|Outcome|CRVO Observation|Standard care consists of observation of the macular edema.
1246110|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
1246057|NCT00105027|E6|Reported Event|BRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
1246058|NCT00105027|E5|Reported Event|BRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
1246059|NCT00105027|E4|Reported Event|BRVO Standard Care|Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
1246060|NCT00105027|E3|Reported Event|CRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
1246061|NCT00105027|E2|Reported Event|CRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
1246062|NCT00105027|E1|Reported Event|CRVO Observation|Standard care consists of observation of the macular edema.
1246063|NCT00105001|B4|Baseline|Total|Total of all reporting groups
1246064|NCT00105001|B3|Baseline|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO~Sirolimus: Given PO"
1246065|NCT00105001|B2|Baseline|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
1246139|NCT00104637|B1|Baseline|Randomized Participants|All enrolled and randomized participants who were administered 25 mg Sildenafil and 25mg placebo at 2 different time periods.
1246140|NCT00104637|P2|Participant Flow|Placebo /Sildenafil|25 mg placebo is taken by mouth 3 times a day for 14 days followed by one week washout and then 25 mg sildenafil by mouth 3 times daily for 14 days.
1246150|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
1256937|NCT00063635|O3|Outcome|Placebo|Matching placebo
1246066|NCT00105001|B1|Baseline|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
1246067|NCT00105001|P3|Participant Flow|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and Mycophenolate Mofetil [MMF] as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO~Sirolimus: Given PO"
1246068|NCT00105001|P2|Participant Flow|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive Mycophenolate Mofetil [MMF] PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
1246069|NCT00105001|P1|Participant Flow|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive Mycophenolate Mofetil [MMF] PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
1246070|NCT00105001|O3|Outcome|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO~Sirolimus: Given PO"
1246101|NCT00104728|E1|Reported Event|Neoadjuvant ZD1839 Preoperative Therapy|"The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food.~At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth.~ZD1839 :"
1246071|NCT00105001|O2|Outcome|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
1246072|NCT00105001|O1|Outcome|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
1246073|NCT00105001|O3|Outcome|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO~Sirolimus: Given PO"
1246074|NCT00105001|O2|Outcome|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
1246075|NCT00105001|O1|Outcome|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
1246076|NCT00105001|O3|Outcome|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO~Sirolimus: Given PO"
1246077|NCT00105001|O2|Outcome|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
1246078|NCT00105001|O1|Outcome|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
1246079|NCT00105001|O3|Outcome|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO~Sirolimus: Given PO"
1246080|NCT00105001|O2|Outcome|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
1246081|NCT00105001|O1|Outcome|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
1246102|NCT00104650|B4|Baseline|Total|Total of all reporting groups
1246103|NCT00104650|B3|Baseline|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
1246104|NCT00104650|B2|Baseline|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
1246082|NCT00105001|O3|Outcome|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO~Sirolimus: Given PO"
1246083|NCT00105001|O2|Outcome|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
1246084|NCT00105001|O1|Outcome|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
1246085|NCT00105001|E3|Reported Event|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO~Sirolimus: Given PO"
1246086|NCT00105001|E2|Reported Event|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
1246141|NCT00104637|P1|Participant Flow|Sildenafil /Placebo|25 mg sildenafil is taken by mouth 3 times a day for 14 days followed by one week washout and then 25 mg placebo by mouth 3 times daily for 14 days.
1246142|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
1246143|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day.
1246144|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
1246145|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day.
1246087|NCT00105001|E1|Reported Event|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
1246088|NCT00104884|B1|Baseline|Depsipeptide|Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression.
1246089|NCT00104884|P1|Participant Flow|Depsipeptide|Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression.
1246090|NCT00104884|O1|Outcome|Depsipeptide|Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression.
1246091|NCT00104884|E1|Reported Event|Depsipeptide|Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression.
1246092|NCT00104871|B1|Baseline|Bortezomib|Bortezomib 1.3 mg/m^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
1246093|NCT00104871|P1|Participant Flow|Bortezomib|Bortezomib 1.3 mg/m^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
1246094|NCT00104871|O1|Outcome|Bortezomib|Bortezomib 1.3 mg/m^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
1246095|NCT00104871|O1|Outcome|Bortezomib|Bortezomib 1.3 mg/m^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
1246096|NCT00104871|E1|Reported Event|Bortezomib|Bortezomib 1.3 mg/m^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
1246097|NCT00104728|B1|Baseline|Neoadjuvant ZD1839 Preoperative Therapy|"The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food.~At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth.~ZD1839 :"
1246098|NCT00104728|P1|Participant Flow|Neoadjuvant ZD1839 Preoperative Therapy|"The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food.~At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth.~ZD1839 :"
1246099|NCT00104728|O1|Outcome|Neoadjuvant ZD1839 Preoperative Therapy|"The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food.~At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth.~ZD1839 :"
1246100|NCT00104728|O1|Outcome|Neoadjuvant ZD1839 Preoperative Therapy|"The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food.~At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth.~ZD1839 :"
1246105|NCT00104650|B1|Baseline|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
1246114|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
1246115|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
1246116|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
1246117|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
1246118|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
1246119|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
1246120|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
1246121|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
1246122|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
1246123|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
1246124|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
1246125|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
1246126|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
1246127|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
1246128|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
1246129|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
1246130|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
1246131|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
1246132|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
1246133|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
1246134|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
1246135|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
1246151|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day.
1246152|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
1246153|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day.
1246154|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
1246155|NCT00104637|O1|Outcome|Sildenafil|Group that received Sildenafil
1246156|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
1246157|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day
1246158|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
1246159|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day
1246160|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
1246161|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day.
1246162|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
1246163|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day
1246164|NCT00104637|E2|Reported Event|Placebo|25 mg placebo is taken by mouth 3 times a day for 14 days followed by one week washout and then 25 mg sildenafil by mouth 3 times daily for 14 days.
1246165|NCT00104637|E1|Reported Event|Sildenafil|25 mg sildenafil is taken by mouth 3 times a day for 14 days followed by one week washout and then 25 mg placebo by mouth 3 times daily for 14 days.
1246166|NCT00104572|B4|Baseline|Total|Total of all reporting groups
1246167|NCT00104572|B3|Baseline|Placebo|"participants will receive a placebo tablet and placebo gel daily for 12 months~Placebo tablet: Daily for 12 months~Placebo gel: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
1246168|NCT00104572|B2|Baseline|Aromatase Inhibitor|"participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months~Anastrozole (Aromatase Inhibitor)~Placebo gel: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
1246233|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
1246169|NCT00104572|B1|Baseline|Transdermal Testosterone|"participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months~Androgel (Testosterone Gel): 1 mg tablet for 12 months~Placebo tablet: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
1246170|NCT00104572|P3|Participant Flow|Placebo|"9 participants will receive a placebo tablet and placebo gel daily for 12 months~Placebo tablet: Daily for 12 months~Placebo gel: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
1246171|NCT00104572|P2|Participant Flow|Aromatase Inhibitor|"13 participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months~Anastrozole (Aromatase Inhibitor)~Placebo gel: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
1246172|NCT00104572|P1|Participant Flow|Transdermal Testosterone|"13 participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months~Androgel (Testosterone Gel): 1 mg tablet for 12 months~Placebo tablet: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
1246173|NCT00104572|O3|Outcome|Placebo|"participants will receive a placebo tablet and placebo gel daily for 12 months~Placebo tablet: Daily for 12 months~Placebo gel: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
1246174|NCT00104572|O2|Outcome|Aromatase Inhibitor|"participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months~Anastrozole (Aromatase Inhibitor)~Placebo gel: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
1246175|NCT00104572|O1|Outcome|Transdermal Testosterone|"participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months~Androgel (Testosterone Gel): 1 mg tablet for 12 months~Placebo tablet: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
1246176|NCT00104572|E3|Reported Event|Placebo|"participants will receive a placebo tablet and placebo gel daily for 12 months~Placebo tablet: Daily for 12 months~Placebo gel: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
1246177|NCT00104572|E2|Reported Event|Aromatase Inhibitor|"participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months~Anastrozole (Aromatase Inhibitor)~Placebo gel: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
1246178|NCT00104572|E1|Reported Event|Transdermal Testosterone|"participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months~Androgel (Testosterone Gel): 1 mg tablet for 12 months~Placebo tablet: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
1246179|NCT00104520|B3|Baseline|Total|Total of all reporting groups
1246180|NCT00104520|B2|Baseline|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
1246181|NCT00104520|B1|Baseline|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
1246182|NCT00104520|P2|Participant Flow|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
1246183|NCT00104520|P1|Participant Flow|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
1246184|NCT00104520|O2|Outcome|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
1246185|NCT00104520|O1|Outcome|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
1246186|NCT00104520|O2|Outcome|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
1246187|NCT00104520|O1|Outcome|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
1246188|NCT00104520|O2|Outcome|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
1246189|NCT00104520|O1|Outcome|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
1246190|NCT00104520|O2|Outcome|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
1246234|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
1246235|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
1246191|NCT00104520|O1|Outcome|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
1246192|NCT00104520|O2|Outcome|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
1246193|NCT00104520|O1|Outcome|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
1246194|NCT00104520|O2|Outcome|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
1246195|NCT00104520|O1|Outcome|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
1246196|NCT00104520|O2|Outcome|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
1246197|NCT00104520|O1|Outcome|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
1246198|NCT00104520|E2|Reported Event|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
1246199|NCT00104520|E1|Reported Event|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
1246200|NCT00104416|B3|Baseline|Total|Total of all reporting groups
1246201|NCT00104416|B2|Baseline|Double-Blind Phase: LTG XR|LTG XR once daily
1246202|NCT00104416|B1|Baseline|Double-Blind Phase: Placebo|Control - matching placebo once daily
1246203|NCT00104416|P5|Participant Flow|Baseline Failures|Baseline failures who entered the CP without receiving treatment in the Double-Blind Phase. Baseline Failures were participants that successfully progressed through the Screening Phase and completed the Baseline Phase of the Double-blind Study, but ultimately did not meet the seizure frequency criteria for randomization into the Double-Blind Treatment Phase of the study. As a result, they were not counted as having started in the Double-Blind Study, but were eligible to enter the CP of the study.
1246204|NCT00104416|P4|Participant Flow|Continuation Phase: LTG/LTG|Participants who received LTG XR in the Double-Blind Phase and then entered the CP, in which they received LTG
1246205|NCT00104416|P3|Participant Flow|Continuation Phase: Placebo/LTG|Participants who received placebo in the Double-Blind Phase and then entered the CP, in which they received LTG
1246206|NCT00104416|P2|Participant Flow|Double-Blind Phase: LTG XR|Lamotrigine (LTG) extended release (XR) once daily
1246207|NCT00104416|P1|Participant Flow|Double-Blind Phase: Placebo|Control - matching placebo once daily
1246208|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
1246209|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
1246210|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
1246211|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
1246212|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
1246213|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
1246214|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
1246215|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
1246216|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
1246217|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
1246218|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
1246219|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
1246220|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
1246221|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
1246222|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
1246223|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
1246224|NCT00104416|O3|Outcome|Baseline Failures|Baseline failures who entered the CP
1246225|NCT00104416|O2|Outcome|Continuation Phase: LTG/LTG|LTG XR participants who entered the CP
1246226|NCT00104416|O1|Outcome|Continuation Phase: Placebo/LTG|Placebo participants who entered the CP
1246227|NCT00104416|O3|Outcome|Baseline Failures|Baseline failures who entered the CP
1246228|NCT00104416|O2|Outcome|Continuation Phase: LTG/LTG|LTG XR participants who entered the CP
1246229|NCT00104416|O1|Outcome|Continuation Phase: Placebo/LTG|Placebo participants who entered the CP
1246230|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
1246231|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
1246244|NCT00104416|E5|Reported Event|Baseline Failures|Baseline failures who entered the CP without receiving treatment in the Double-Blind Phase. Baseline Failures were participants that successfully progressed through the Screening Phase and completed the Baseline Phase of the Double-blind Study, but ultimately did not meet the seizure frequency criteria for randomization into the Double-Blind Treatment Phase of the study. As a result, they were not counted as having started in the Double-Blind Study, but were eligible to enter the CP of the study.
1246245|NCT00104416|E4|Reported Event|Continuation Phase: LTG/LTG|Participants who received LTG XR in the Double-Blind Phase and then entered the CP, in which they received LTG
1246246|NCT00104416|E3|Reported Event|Continuation Phase: Placebo/LTG|Participants who received placebo in the Double-Blind Phase and then entered the CP, in which they received LTG
1246247|NCT00104416|E2|Reported Event|Double-Blind Phase: LTG XR|Lamotrigine (LTG) extended release (XR) once daily
1246248|NCT00104416|E1|Reported Event|Double-Blind Phase: Placebo|Control - matching placebo once daily
1246249|NCT00104299|B3|Baseline|Total|Total of all reporting groups
1246250|NCT00104299|B2|Baseline|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
1246251|NCT00104299|B1|Baseline|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
1246252|NCT00104299|P2|Participant Flow|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
1246253|NCT00104299|P1|Participant Flow|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
1246254|NCT00104299|O2|Outcome|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
1246255|NCT00104299|O1|Outcome|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
1246256|NCT00104299|O2|Outcome|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
1246257|NCT00104299|O1|Outcome|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
1246258|NCT00104299|O2|Outcome|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
1246259|NCT00104299|O1|Outcome|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
1246260|NCT00104299|O2|Outcome|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
1246261|NCT00104299|O1|Outcome|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
1246550|NCT00103207|O1|Outcome|Never Smoker|Eligible and treated patients who never smoked.
1246262|NCT00104299|O2|Outcome|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
1246263|NCT00104299|O1|Outcome|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
1246264|NCT00104299|O2|Outcome|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
1246265|NCT00104299|O1|Outcome|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
1246266|NCT00104299|O2|Outcome|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
1246267|NCT00104299|O1|Outcome|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
1246268|NCT00104299|O2|Outcome|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
1246269|NCT00104299|O1|Outcome|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
1246416|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
1246270|NCT00104299|E2|Reported Event|Control Group|"Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled Detailed Description for additional treatment information."
1246271|NCT00104299|E1|Reported Event|Rituximab|"Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled Detailed Description for additional treatment information."
1246272|NCT00104247|B3|Baseline|Total|Total of all reporting groups
1246273|NCT00104247|B2|Baseline|Placebo|Placebo
1246274|NCT00104247|B1|Baseline|Sapropterin Dihydrochloride|Patients administered 10 mg /kg orally once daily.
1246275|NCT00104247|P2|Participant Flow|Placebo|Placebo
1246276|NCT00104247|P1|Participant Flow|Sapropterin Dihydrochloride|Patients administered 10 mg /kg orally once daily.
1246277|NCT00104247|O2|Outcome|Placebo|Placebo
1246278|NCT00104247|O1|Outcome|Sapropterin Dihydrochloride|Patients administered 10 mg /kg orally once daily.
1246279|NCT00104247|E2|Reported Event|Placebo|Placebo
1246280|NCT00104247|E1|Reported Event|Sapropterin Dihydrochloride|Patients administered 10 mg /kg orally once daily.
1246281|NCT00104234|B3|Baseline|Total|Total of all reporting groups
1246282|NCT00104234|B2|Baseline|Placebo/rhASB|Patients received placebo in the double-blind study (ASB-03-05, NCT00067470)then received rhASB in the extension study (ASB-03-06).
1246283|NCT00104234|B1|Baseline|rhASB/rhASB|Patients received rhASB in the double-blind study(ASB-03-05, NCT00067470)and continued to receive rhASB in the extension study(ASB-03-06).
1246284|NCT00104234|P2|Participant Flow|Placebo/rhASB|Patients received placebo in the double-blind study (ASB-03-05, NCT00067470)then received rhASB in the extension study (ASB-03-06).
1246285|NCT00104234|P1|Participant Flow|rhASB/rhASB|Patients received rhASB in the double-blind study(ASB-03-05, NCT00067470)and continued to receive rhASB in the extension study(ASB-03-06).
1246286|NCT00104234|O1|Outcome|All Participants (N=37)|rhASB/rhASB and placebo/rhASB groups were combined for analysis.
1246287|NCT00104234|O2|Outcome|Placebo/rhASB|Patients received placebo in the double-blind study (ASB-03-05, NCT00067470)then received rhASB in the extension study (ASB-03-06).
1246288|NCT00104234|O1|Outcome|rhASB/rhASB|Patients received rhASB in the double-blind study(ASB-03-05, NCT00067470)and continued to receive rhASB in the extension study(ASB-03-06).
1246289|NCT00104234|O2|Outcome|Placebo/rhASB|Patients received placebo in the double-blind study (ASB-03-05, NCT00067470)then received rhASB in the extension study (ASB-03-06).
1246290|NCT00104234|O1|Outcome|rhASB/rhASB|Patients received rhASB in the double-blind study(ASB-03-05, NCT00067470)and continued to receive rhASB in the extension study(ASB-03-06).
1246291|NCT00104234|E1|Reported Event|All Participants|rhASB/rhASB and placebo/rhASB groups were combined for analysis.
1246292|NCT00104104|B3|Baseline|Total|Total of all reporting groups
1246293|NCT00104104|B2|Baseline|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
1246294|NCT00104104|B1|Baseline|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
1246295|NCT00104104|P2|Participant Flow|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
1246296|NCT00104104|P1|Participant Flow|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
1246297|NCT00104104|O2|Outcome|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
1246298|NCT00104104|O1|Outcome|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
1246299|NCT00104104|O2|Outcome|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
1246300|NCT00104104|O1|Outcome|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
1246301|NCT00104104|O2|Outcome|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
1246302|NCT00104104|O1|Outcome|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
1246303|NCT00104104|O2|Outcome|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
1246417|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
1246304|NCT00104104|O1|Outcome|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
1246305|NCT00104104|O2|Outcome|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
1246306|NCT00104104|O1|Outcome|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
1246307|NCT00104104|E2|Reported Event|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
1246308|NCT00104104|E1|Reported Event|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
1246309|NCT00104052|B1|Baseline|PEG-Intron Plus REBETOL|SCH 54031 PEG-Intron (peginterferon alfa-2b) 60 µg/m2 subcutaneous injection once weekly plus SCH 18908 REBETOL (ribavirin) 15 mg/kg PO daily in two divided doses for 48 weeks for subjects with Genotypes 1,4,5,6 and high-viral-load (≥600,000 IU/mL) Genotype 3 subjects. For subjects with Genotype 2 or low-viral-load Genotype 3 (<600,000 IU/mL), the same treatment will be given for 24 weeks.
1246310|NCT00104052|P1|Participant Flow|PEG-Intron Plus REBETOL|SCH 54031 PEG-Intron (peginterferon alfa-2b) 60 µg/m2 subcutaneous injection once weekly plus SCH 18908 REBETOL (ribavirin) 15 mg/kg PO daily in two divided doses for 48 weeks for subjects with Genotypes 1,4,5,6 and high-viral-load (≥600,000 IU/mL) Genotype 3 subjects. For subjects with Genotype 2 or low-viral-load Genotype 3 (<600,000 IU/mL), the same treatment will be given for 24 weeks.
1246311|NCT00104052|O1|Outcome|PEG-Intron Plus REBETOL|SCH 54031 PEG-Intron (peginterferon alfa-2b) 60 µg/m2 subcutaneous injection once weekly plus SCH 18908 REBETOL (ribavirin) 15 mg/kg PO daily in two divided doses for 48 weeks for subjects with Genotypes 1,4,5,6 and high-viral-load (≥600,000 IU/mL) Genotype 3 subjects. For subjects with Genotype 2 or low-viral-load Genotype 3 (<600,000 IU/mL), the same treatment will be given for 24 weeks.
1246312|NCT00104052|E1|Reported Event|PEG-Intron Plus REBETOL|
1246313|NCT00103857|B8|Baseline|Total|Total of all reporting groups
1246314|NCT00103857|B7|Baseline|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. OLC|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) OLC (Open-label Cohort) includes data from non-randomized patients assigned to receive treatment with open-label, oral tablets of sitagliptin and metformin. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning on Day 1. The dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients continued to take open-label sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the Phase A treatment period of up to 24 weeks. Results presented for the OLC are through Week 24. Patients in the OLC completed the study at Week 24.
1246315|NCT00103857|B6|Baseline|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
1246626|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
1246316|NCT00103857|B5|Baseline|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246317|NCT00103857|B4|Baseline|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246318|NCT00103857|B3|Baseline|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246418|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
1246419|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
1246420|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
1246421|NCT00103844|E2|Reported Event|IMATINIB|Imatinib 400 mg BID
1246319|NCT00103857|B2|Baseline|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246320|NCT00103857|B1|Baseline|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
1246321|NCT00103857|P7|Participant Flow|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. OLC|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) OLC (Open-label Cohort) includes data from non-randomized patients assigned to receive treatment with open-label, oral tablets of sitagliptin and metformin. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning on Day 1. The dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients continued to take open-label sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the Phase A treatment period of up to 24 weeks. Results presented for the OLC are through Week 24. Patients in the OLC completed the study at Week 24.
1246322|NCT00103857|P6|Participant Flow|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
1246323|NCT00103857|P5|Participant Flow|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246324|NCT00103857|P4|Participant Flow|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246325|NCT00103857|P3|Participant Flow|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246326|NCT00103857|P2|Participant Flow|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246327|NCT00103857|P1|Participant Flow|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
1246422|NCT00103844|E1|Reported Event|DASATINIB|Dasatinib 70 mg twice a day (BID)
1246423|NCT00103740|B3|Baseline|Total|Total of all reporting groups
1246650|NCT00102687|O1|Outcome|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23.
1246328|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
1246329|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246330|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246331|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246332|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246333|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
1246629|NCT00102687|O1|Outcome|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23
1246334|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
1246335|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246336|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246424|NCT00103740|B2|Baseline|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1246735|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
1246337|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246338|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246339|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
1246340|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
1246341|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246342|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246343|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246344|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246345|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
1246425|NCT00103740|B1|Baseline|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1246606|NCT00102804|O2|Outcome|Placebo and BSC|"Placebo: IV administration, q 21 days.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
1246346|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
1246347|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246348|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246349|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246350|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246351|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
1246352|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
1246353|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246354|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246426|NCT00103740|P2|Participant Flow|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1246736|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
1246355|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246356|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246357|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
1246358|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
1246359|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246360|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246361|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246362|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246363|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
1246427|NCT00103740|P1|Participant Flow|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1246646|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
1246364|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
1246365|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246366|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246367|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246368|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246369|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
1246370|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
1246371|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246372|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246428|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1246647|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
1246373|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246374|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246375|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
1246376|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
1246377|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246378|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246379|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246380|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246381|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
1246429|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1246648|NCT00102687|O3|Outcome|Initial Period Treatment Continued Into Maintenance|Combines participants who continued their original treatment assigned during the initial study period through month 7 to month 23.
1246382|NCT00103857|E7|Reported Event|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. OLC|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) OLC (Open-label Cohort) includes data from non-randomized patients assigned to receive treatment with open-label, oral tablets of sitagliptin and metformin. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning on Day 1. The dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients continued to take open-label sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the Phase A treatment period of up to 24 weeks. Results presented for the OLC are through Week 24. Patients in the OLC completed the study at Week 24.
1246383|NCT00103857|E6|Reported Event|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
1246384|NCT00103857|E5|Reported Event|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246385|NCT00103857|E4|Reported Event|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246386|NCT00103857|E3|Reported Event|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246387|NCT00103857|E2|Reported Event|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
1246711|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
1246388|NCT00103857|E1|Reported Event|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
1246389|NCT00103844|B3|Baseline|Total|Total of all reporting groups
1246390|NCT00103844|B2|Baseline|Imatinib|Imatinib 400 mg BID
1246391|NCT00103844|B1|Baseline|Dasatinib|Dasatinib 70 mg twice a day (BID)
1246392|NCT00103844|P2|Participant Flow|Imatinib First|Imatinib 400 mg BID in the first intervention period and, if intolerance to imatinib or progression or lack of efficacy, dasatinib 70 mg BID in the second intervention period (after washout period).
1246393|NCT00103844|P1|Participant Flow|Dasatinib First|Dasatinib 70 mg twice a day (BID) in the first intervention period and, if intolerance to dasatinib or progression, imatinib 400 mg BID in the second intervention period (after washout period).
1246394|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
1246395|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
1246396|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
1246397|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
1246398|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
1246399|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
1246400|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
1246401|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
1246402|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
1246403|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
1246404|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
1246405|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
1246406|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
1246407|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
1246430|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1246431|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1246432|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1246433|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1246434|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1246435|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1246436|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1246437|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1246438|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1246439|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1246440|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1246441|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1246627|NCT00102687|O3|Outcome|Initial Period Treatment Continued Into Maintenance|Combines participants who continued their original treatment assigned during the initial study period through month 7 to month 23.
1246442|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1246443|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1246444|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1246445|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1246446|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1246447|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1246448|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1246449|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1246450|NCT00103740|E2|Reported Event|Risedronate|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1246451|NCT00103740|E1|Reported Event|Zoledronic Acid|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1246452|NCT00103662|B3|Baseline|Total|Total of all reporting groups
1246453|NCT00103662|B2|Baseline|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
1246454|NCT00103662|B1|Baseline|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
1246455|NCT00103662|P2|Participant Flow|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
1246456|NCT00103662|P1|Participant Flow|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
1246457|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
1246458|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
1246459|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
1246460|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
1246461|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
1246462|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
1246463|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
1246464|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
1246465|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
1246466|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
1246467|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
1246468|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
1246469|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
1246470|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
1246649|NCT00102687|O2|Outcome|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23.
1246471|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
1246472|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
1246473|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
1246474|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
1246475|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
1246476|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
1246477|NCT00103662|E2|Reported Event|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
1246478|NCT00103662|E1|Reported Event|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
1246479|NCT00103610|B3|Baseline|Total|Total of all reporting groups
1246480|NCT00103610|B2|Baseline|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1246481|NCT00103610|B1|Baseline|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1246525|NCT00103311|O1|Outcome|Arm I|"Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
1246482|NCT00103610|P2|Participant Flow|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1246483|NCT00103610|P1|Participant Flow|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1246484|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1246485|NCT00103610|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1246486|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1246487|NCT00103610|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1246488|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1246489|NCT00103610|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1246490|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1246776|NCT00102063|O3|Outcome|Placebo Group|Participants were given a single pill administered once daily
1246491|NCT00103610|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1246492|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1246493|NCT00103610|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1246494|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1246495|NCT00103610|O1|Outcome|G-CSF + Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1246496|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1246497|NCT00103610|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1246498|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1246499|NCT00103610|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1246500|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1256938|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
1246501|NCT00103610|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1246502|NCT00103610|E2|Reported Event|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1246503|NCT00103610|E1|Reported Event|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
1246504|NCT00103506|B3|Baseline|Total|Total of all reporting groups
1246505|NCT00103506|B2|Baseline|Doxil/Caelyx Plus Velcade (Bortezomib)|Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
1246506|NCT00103506|B1|Baseline|Velcade (Bortezomib) Monotherapy|Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
1246507|NCT00103506|P2|Participant Flow|Doxil/Caelyx Plus Velcade (Bortezomib)|Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
1246508|NCT00103506|P1|Participant Flow|Velcade (Bortezomib) Monotherapy|Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
1246509|NCT00103506|O2|Outcome|Doxil/Caelyx Plus Velcade (Bortezomib)|Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
1246510|NCT00103506|O1|Outcome|Velcade (Bortezomib) Monotherapy|Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
1246511|NCT00103506|O2|Outcome|Doxil/Caelyx Plus Velcade (Bortezomib)|Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
1247039|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
1246512|NCT00103506|O1|Outcome|Velcade (Bortezomib) Monotherapy|Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
1246513|NCT00103506|O2|Outcome|Doxil/Caelyx Plus Velcade (Bortezomib)|Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
1246514|NCT00103506|O1|Outcome|Velcade (Bortezomib) Monotherapy|Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
1246515|NCT00103506|E2|Reported Event|Doxil/Caelyx Plus Velcade (Bortezomib)|Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
1246516|NCT00103506|E1|Reported Event|Velcade (Bortezomib) Monotherapy|Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
1246517|NCT00103311|B3|Baseline|Total|Total of all reporting groups
1246518|NCT00103311|B2|Baseline|Arm II|"Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
1246519|NCT00103311|B1|Baseline|Arm I|"Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
1246520|NCT00103311|P2|Participant Flow|Arm II|"Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
1246521|NCT00103311|P1|Participant Flow|Arm I|"Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
1246522|NCT00103311|O2|Outcome|Arm II|"Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
1246523|NCT00103311|O1|Outcome|Arm I|"Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
1246524|NCT00103311|O2|Outcome|Arm II|"Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
1246548|NCT00103207|O1|Outcome|Never Smoker|Eligible and treated patients who never smoked.
1246549|NCT00103207|O2|Outcome|Former/Current Smoker|Eligible and treated patients who are former or current smokers.
1246526|NCT00103311|O2|Outcome|Arm II|"Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
1246527|NCT00103311|O1|Outcome|Arm I|"Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
1246528|NCT00103311|E2|Reported Event|Arm II|"Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
1246529|NCT00103311|E1|Reported Event|Arm I|"Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
1246530|NCT00103259|B3|Baseline|Total|Total of all reporting groups
1246531|NCT00103259|B2|Baseline|Arm II (Bortezomib)|Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
1246532|NCT00103259|B1|Baseline|Arm I (Bortezomib+Irinotecan)|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1246533|NCT00103259|P2|Participant Flow|Arm II (Bortezomib)|Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
1246534|NCT00103259|P1|Participant Flow|Arm I (Bortezomib+Irinotecan)|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1246535|NCT00103259|O2|Outcome|Arm II (Bortezomib)|Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
1246536|NCT00103259|O1|Outcome|Arm I (Bortezomib+Irinotecan)|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1246537|NCT00103259|O2|Outcome|Arm II (Bortezomib)|Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
1246538|NCT00103259|O1|Outcome|Arm I (Bortezomib+Irinotecan)|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1246539|NCT00103259|O1|Outcome|Cross-over From Bortezomib to Combined Arm|Patients progressed on bortezomib in step 1 crossed over to the combination arm. Response rate is evaluated in these patients.
1246540|NCT00103259|O2|Outcome|Arm II (Bortezomib)|Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
1246541|NCT00103259|O1|Outcome|Arm I (Bortezomib+Irinotecan)|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1246542|NCT00103259|E3|Reported Event|Cross-over Patients|11 patients crossed over to bortezomib + irinotecan after progressed on bortezomib single agent. Adverse events were reported for the 11 patients while receiving the combination therapy.
1246543|NCT00103259|E2|Reported Event|Arm II (Bortezomib)|Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
1246544|NCT00103259|E1|Reported Event|Arm I (Bortezomib+Irinotecan)|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1246545|NCT00103207|B1|Baseline|Cetuximab|"Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced.~Only eligible patients with confirmed diagnosis are included in the main analysis."
1246546|NCT00103207|P1|Participant Flow|Cetuximab|"Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced.~Only eligible patients with confirmed diagnosis are included in the main analysis."
1246547|NCT00103207|O2|Outcome|Former/Current Smoker|Eligible and treated patients who are former or current smokers.
1256939|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
1246551|NCT00103207|O1|Outcome|Cetuximab|"Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced.~Only eligible patients with confirmed diagnosis are included in the main analysis."
1246552|NCT00103207|O1|Outcome|Cetuximab|"Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced.~Only eligible patients with confirmed diagnosis are included in the main analysis."
1246553|NCT00103207|O1|Outcome|Cetuximab|"Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced.~Only eligible patients with confirmed diagnosis are included in the main analysis."
1246554|NCT00103207|E1|Reported Event|Cetuximab|All treated patients were evaluated for toxicities.
1246555|NCT00103194|B1|Baseline|GW572016 (Lapatinib)|GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
1246556|NCT00103194|P1|Participant Flow|GW572016 (Lapatinib)|GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
1246557|NCT00103194|O1|Outcome|GW572016 (Lapatinib)|GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
1246558|NCT00103194|O1|Outcome|GW572016 (Lapatinib)|GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
1246559|NCT00103194|O1|Outcome|GW572016 (Lapatinib)|GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
1246560|NCT00103194|O1|Outcome|GW572016 (Lapatinib)|GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
1246561|NCT00103194|E1|Reported Event|GW572016 (Lapatinib)|GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
1246562|NCT00103142|B3|Baseline|Total|Total of all reporting groups
1246563|NCT00103142|B2|Baseline|Experimental PANVAC-V + PANVAC-F + GM-CSF|Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (Granulocyte-macrophage colony-stimulating factor or GM-CSF) subcutaneous (SC) into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
1246564|NCT00103142|B1|Baseline|Experimental PANVAC-V + PANVAC-F + DC|Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-Carcinoembryonic antigen (CEA)-Mucin 1 (MUC-1)-TRIad of COstimulatory Molecules (TRICOM) (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine subcutaneous (SC) and intradermally (ID) on days 28, 56, and 84.
1246565|NCT00103142|P2|Participant Flow|PANVAC-V + PANVAC-F + GM-CSF|Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) SC into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
1246566|NCT00103142|P1|Participant Flow|PANVAC-V + PANVAC-F + DC|Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-CEA-MUC-1-TRICOM (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine SC and ID on days 28, 56, and 84.
1246567|NCT00103142|O2|Outcome|PANVAC-V + PANVAC-F + GM-CSF|Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) SC into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
1246628|NCT00102687|O2|Outcome|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23
1246568|NCT00103142|O1|Outcome|PANVAC-V + PANVAC-F + DC|Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-CEA-MUC-1-TRICOM (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine SC and ID on days 28, 56, and 84.
1246569|NCT00103142|O2|Outcome|PANVAC-V + PANVAC-F + GM-CSF|Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
1246570|NCT00103142|O1|Outcome|PANVAC-V + PANVAC-F + DC|Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-carcinoembryonic antigen (CEA)- mucin 1 (MUC-1)-TRiad of Costimulatory Molecules (TRICOM) (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine subcutaneously (SC) and intradermally (ID) on days 28, 56, and 84.
1246571|NCT00103142|E2|Reported Event|Arm II|Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) SC into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
1246572|NCT00103142|E1|Reported Event|Arm I|Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-CEA-MUC-1-TRICOM (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine SC and ID on days 28, 56, and 84.
1246573|NCT00103116|B1|Baseline|Vaccine|therapeutic autologous dendritic cells : Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure. Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part.
1246574|NCT00103116|P1|Participant Flow|Vaccine|therapeutic autologous dendritic cells : Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure. Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part.
1246575|NCT00103116|O1|Outcome|Vaccine|therapeutic autologous dendritic cells : Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure. Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part.
1246576|NCT00103116|O1|Outcome|Vaccine|therapeutic autologous dendritic cells : Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure. Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part.
1246577|NCT00103116|E1|Reported Event|Vaccine|therapeutic autologous dendritic cells : Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure. Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part.
1246578|NCT00103012|B4|Baseline|Total|Total of all reporting groups
1247040|NCT00101647|O3|Outcome|Total|
1246579|NCT00103012|B3|Baseline|Influence of Panax Ginseng on Lopinavir/Ritonavir Disposition|Lopinavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Panax ginseng (500 mg twice daily).
1246580|NCT00103012|B2|Baseline|Influence of Echinacea on Lopinavir/Ritonavir Disposition|Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Echinacea(500 mg three times daily).
1246581|NCT00103012|B1|Baseline|Influence of Ginkgo Biloba on Lopinavir/Ritonavir Disposition|Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Ginkgo Biloba administration (120 mg two times daily) to healthy human volunteers.
1246582|NCT00103012|P3|Participant Flow|Influence of Panax Ginseng on Lopinavir/Ritonavir Disposition|Lopinavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Panax ginseng (500 mg twice daily).
1246583|NCT00103012|P2|Participant Flow|Influence of Echinacea on Lopinavir/Ritonavir Disposition|Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Echinacea(500 mg three times daily).
1246584|NCT00103012|P1|Participant Flow|Influence of Ginkgo Biloba on Lopinavir/Ritonavir Disposition|Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Ginkgo Biloba administration (120 mg two times daily) to healthy human volunteers.
1246585|NCT00103012|O3|Outcome|Influence of Panax Ginseng on Lopinavir Disposition|Lopinavir (administered as lopinavir-ritonavir X 2 weeks)pharmacokinetics determined before, and after 14-28 days of Panax ginseng (500 mg twice daily).
1246586|NCT00103012|O2|Outcome|Influence of Echinacea on Lopinavir Disposition|Lopinavir (administered as lopinavir-ritonavir X 2 weeks)pharmacokinetics determined before, and after 14 days of Echinacea purpurea administration (500 mg three times daily) to healthy human volunteers.
1246587|NCT00103012|O1|Outcome|Influence of Ginkgo Biloba on Lopinavir Disposition|Lopinavir pharmacokinetics (administered as lopinavir-ritonavir X 2 weeks) determined before, and after 14 days of Ginkgo Biloba administration (120 mg two times daily) to healthy human volunteers.
1246588|NCT00103012|E3|Reported Event|Influence of Panax Ginseng on Lopinavir/Ritonavir Disposition|Lopinavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Panax ginseng (500 mg twice daily).
1246589|NCT00103012|E2|Reported Event|Influence of Echinacea on Lopinavir/Ritonavir Disposition|Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Echinacea(500 mg three times daily).
1246590|NCT00103012|E1|Reported Event|Influence of Ginkgo Biloba on Lopinavir/Ritonavir Disposition|Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Ginkgo Biloba administration (120 mg two times daily) to healthy human volunteers.
1246591|NCT00102804|B3|Baseline|Total|Total of all reporting groups
1246592|NCT00102804|B2|Baseline|Placebo and BSC|"Placebo: IV administration, q 21 days.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
1256940|NCT00063635|E3|Reported Event|Placebo|Matching placebo
1246593|NCT00102804|B1|Baseline|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
1246594|NCT00102804|P2|Participant Flow|Placebo and BSC|"Placebo: IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
1246595|NCT00102804|P1|Participant Flow|Pemetrexed and BSC|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV) administration, every (q) 21 days, until disease progression.~Best Supportive Care (BSC): Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
1246596|NCT00102804|O2|Outcome|Placebo and BSC|"Placebo: IV administration, q 21 days.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
1246597|NCT00102804|O1|Outcome|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
1246598|NCT00102804|O2|Outcome|Placebo and BSC|"Placebo: IV administration, q 21 days.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
1246599|NCT00102804|O1|Outcome|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
1246600|NCT00102804|O2|Outcome|Placebo and BSC|"Placebo: IV administration, q 21 days.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
1246601|NCT00102804|O1|Outcome|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
1246602|NCT00102804|O2|Outcome|Placebo and BSC|"Placebo: IV administration, q 21 days.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
1246603|NCT00102804|O1|Outcome|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
1246604|NCT00102804|O2|Outcome|Placebo and BSC|"Placebo: IV administration, q 21 days.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
1246605|NCT00102804|O1|Outcome|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
1260725|NCT00040846|B7|Baseline|Total|Total of all reporting groups
1246607|NCT00102804|O1|Outcome|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
1246608|NCT00102804|O2|Outcome|Placebo and BSC|"Placebo: IV administration, q 21 days.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
1246609|NCT00102804|O1|Outcome|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
1246610|NCT00102804|E2|Reported Event|Placebo and BSC|"Placebo: IV administration, q 21 days.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
1246611|NCT00102804|E1|Reported Event|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
1246612|NCT00102687|B4|Baseline|Total|Total of all reporting groups
1246613|NCT00102687|B3|Baseline|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
1246614|NCT00102687|B2|Baseline|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
1246615|NCT00102687|B1|Baseline|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
1246616|NCT00102687|P5|Participant Flow|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23
1246617|NCT00102687|P4|Participant Flow|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23
1246618|NCT00102687|P3|Participant Flow|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
1246619|NCT00102687|P2|Participant Flow|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
1246620|NCT00102687|P1|Participant Flow|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
1246621|NCT00102687|O3|Outcome|Initial Period Treatment Continued Into Maintenance|Combines participants who continued their original treatment assigned during the initial study period through month 7 to month 23.
1246622|NCT00102687|O2|Outcome|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23.
1246623|NCT00102687|O1|Outcome|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23.
1246624|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
1246625|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
1246630|NCT00102687|O3|Outcome|Initial Period Treatment Continued Into Maintenance|Combines participants who continued their original treatment assigned during the initial study period through month 7 to month 23.
1246631|NCT00102687|O2|Outcome|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23.
1246632|NCT00102687|O1|Outcome|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23.
1246633|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
1246634|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
1246635|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
1246636|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
1246637|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
1246638|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
1246639|NCT00102687|O3|Outcome|Initial Period Treatment Continued Into Maintenance|Combines participants who continued their treatment assigned during the initial study period through month 7 to month 23.
1246640|NCT00102687|O2|Outcome|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23.
1246641|NCT00102687|O1|Outcome|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23.
1246642|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
1246643|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
1246644|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
1246645|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
1261738|NCT00026312|B2|Baseline|Regimen B|Regimen B - RA + Immunotherapy
1246651|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
1246652|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
1246653|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
1246654|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
1246655|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
1246656|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
1246657|NCT00102687|O3|Outcome|Initial Period Treatment Continued Into Maintenance|Combines participants who continued their original treatment assigned during the initial study period through month 7 to month 23.
1246658|NCT00102687|O2|Outcome|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23
1246659|NCT00102687|O1|Outcome|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23
1246660|NCT00102687|O3|Outcome|Initial Period Treatment Continued Into Maintenance|Combines participants who continued their original treatment assigned during the initial study period through month 7 to month 23.
1246661|NCT00102687|O2|Outcome|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23
1246662|NCT00102687|O1|Outcome|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23
1246663|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
1246664|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
1246665|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
1246666|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
1246667|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
1246668|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
1246669|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
1246670|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
1246671|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
1246672|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
1246673|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
1246674|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
1246675|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
1257833|NCT00055497|O3|Outcome|DB Adalimumab 40 mg Every Week (ew)|
1246676|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
1246677|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
1246678|NCT00102687|E5|Reported Event|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23
1246679|NCT00102687|E4|Reported Event|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23
1246680|NCT00102687|E3|Reported Event|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
1246681|NCT00102687|E2|Reported Event|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
1246682|NCT00102687|E1|Reported Event|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
1246683|NCT00102596|B1|Baseline|All Participants|Baseline is included for all participants who passed screening and received at least 1 dose of 1-octanol, whether in Part A, B or C
1246684|NCT00102596|P2|Participant Flow|Part B Then C: Fixed Dose|"In Part B, subjects fasted overnight for 6 hours and received 64 mg/kg 1-octanol at 6AM of both formulations:~1) 1-octanol adsorbed to microcrystalline cellulose, NF (Avicel PH 102, FMC Corp., Philadelphia, PA), and fine particle silica (Sipernat 50S, Evonik Degussa Corp., Parsippany, NJ) and encapsulated in 50 mg and 250 mg dosages; or 2) a soft-gel capsule containing 1-octanol embedded in soybean oil at 50 mg and 800 mg dosages (Best Formulations Inc, City of Industry, CA).~At the completion of Parts A and B, an exploratory Part C was added in which subjects fasted overnight for 6 hours and received 128 mg/kg 1-octanol at 6AM of both formulations."
1246685|NCT00102596|P1|Participant Flow|Part A: Dose Escalation|"Subjects fasted overnight for 6 hours and received 1, 4, 8, 16, 32 and 64 mg/kg 1-octanol at 6AM on different days. There were 2 formulations:~1) 2 participants received 1-octanol adsorbed to microcrystalline cellulose, NF (Avicel PH 102, FMC Corp., Philadelphia, PA), and fine particle silica (Sipernat 50S, Evonik Degussa Corp., Parsippany, NJ) and encapsulated in 50 mg and 250 mg dosages; and 2) two participants received a soft-gel capsule containing 1-octanol embedded in soybean oil at 50 mg and 800 mg dosages (Best Formulations Inc, City of Industry, CA)."
1246686|NCT00102596|O1|Outcome|1-Octanol Dose|Subjects fasted overnight for 6 hours. At 6AM subjects received 1-128 mg/kg of 1-octanol
1246687|NCT00102596|O1|Outcome|1-Octanol Dose|Subjects fasted overnight for 6 hours. At 6AM subjects received 1-128 mg/kg of the 1-octanol
1246688|NCT00102596|O2|Outcome|64 mg/kg 1-Octanol Soybean Oil Embedded (SOY) Formulation|Subjects fasted overnight for 6 hours. At 6AM subjects received 64 mg/kg of the 1-octanol in a soft-gel capsule containing 1-octanol embedded in soybean oil at 50 mg and 800 mg dosages (Best Formulations Inc, City of Industry, CA).
1246689|NCT00102596|O1|Outcome|64 mg/kg 1-Octanol Cellulose-based (CEL) Formulation|Subjects fasted overnight for 6 hours. At 6AM subjects received 64 mg/kg of the 1-octanol adsorbed to microcrystalline cellulose, NF (Avicel PH 102, FMC Corp., Philadelphia, PA), and fine particle silica (Sipernat 50S, Evonik Degussa Corp., Parsippany, NJ) and encapsulated in 50 mg and 250 mg dosages.
1246690|NCT00102596|O2|Outcome|64 mg/kg 1-Octanol Soybean Oil Embedded (SOY) Formulation|Subjects fasted overnight for 6 hours. At 6AM subjects received 64 mg/kg of the 1-octanol in a soft-gel capsule containing 1-octanol embedded in soybean oil at 50 mg and 800 mg dosages (Best Formulations Inc, City of Industry, CA).
1246691|NCT00102596|O1|Outcome|64 mg/kg 1-Octanol Cellulose-based (CEL) Formulation|Subjects fasted overnight for 6 hours. At 6AM subjects received 64 mg/kg of the 1-octanol adsorbed to microcrystalline cellulose, NF (Avicel PH 102, FMC Corp., Philadelphia, PA), and fine particle silica (Sipernat 50S, Evonik Degussa Corp., Parsippany, NJ) and encapsulated in 50 mg and 250 mg dosages.
1246692|NCT00102596|E1|Reported Event|1-octanol Dose|Subjects fasted overnight for 6 hours. At 6AM subjects received 1-128 mg/kg of 1-octanol
1246693|NCT00102518|B1|Baseline|NCT00102063 and NCT00110461 Subjects|All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
1246694|NCT00102518|P1|Participant Flow|NCT00102063 and NCT00110461 Subjects|All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
1246695|NCT00102518|O1|Outcome|NCT00102063 and NCT00110461 Subjects|All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
1246696|NCT00102518|O1|Outcome|NCT00102063 and NCT00110461 Subjects|All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
1246697|NCT00102518|O1|Outcome|NCT00102063 and NCT00110461 Subjects|All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
1246698|NCT00102518|E1|Reported Event|NCT00102063 and NCT00110461 Subjects|All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
1246699|NCT00102440|B4|Baseline|Total|Total of all reporting groups
1246700|NCT00102440|B3|Baseline|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
1246701|NCT00102440|B2|Baseline|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
1246702|NCT00102440|B1|Baseline|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
1246703|NCT00102440|P3|Participant Flow|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
1246704|NCT00102440|P2|Participant Flow|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
1246705|NCT00102440|P1|Participant Flow|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
1246706|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
1246707|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
1246708|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
1246709|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
1246710|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
1257834|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Every Other Week (Eow)|
1246712|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
1246713|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
1246714|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
1246715|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
1246716|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
1246717|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
1246718|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
1246719|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
1246720|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
1246721|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
1246722|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
1246723|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
1246724|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
1246725|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
1246726|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
1246727|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
1246728|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
1246729|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
1246730|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
1246731|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
1246732|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
1246733|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
1246734|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
1261739|NCT00026312|B1|Baseline|Regimen A|Randomized to Regimen A - RA Only
1246737|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
1246738|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
1246739|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
1246740|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
1246741|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
1246742|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
1246743|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
1246744|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
1246745|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
1246746|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
1246747|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
1246748|NCT00102440|E3|Reported Event|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
1246749|NCT00102440|E2|Reported Event|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
1246750|NCT00102440|E1|Reported Event|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
1246751|NCT00102063|B4|Baseline|Total|Total of all reporting groups
1246752|NCT00102063|B3|Baseline|Placebo Group|Participants were given a single pill administered once daily
1246753|NCT00102063|B2|Baseline|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
1246754|NCT00102063|B1|Baseline|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
1246755|NCT00102063|P3|Participant Flow|Placebo Group|Participants were given a single pill administered once daily
1246756|NCT00102063|P2|Participant Flow|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
1246757|NCT00102063|P1|Participant Flow|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
1246758|NCT00102063|O3|Outcome|Placebo Group|Participants were given a single pill administered once daily
1246759|NCT00102063|O2|Outcome|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
1246760|NCT00102063|O1|Outcome|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
1246761|NCT00102063|O3|Outcome|Placebo Group|Participants were given a single pill administered once daily
1246762|NCT00102063|O2|Outcome|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
1257835|NCT00055497|O1|Outcome|Placebo|
1246763|NCT00102063|O1|Outcome|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
1246764|NCT00102063|O3|Outcome|Placebo Group|Participants were given a single pill administered once daily
1246765|NCT00102063|O2|Outcome|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
1246766|NCT00102063|O1|Outcome|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
1246767|NCT00102063|O3|Outcome|Placebo Group|Participants were given a single pill administered once daily
1246768|NCT00102063|O2|Outcome|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
1246769|NCT00102063|O1|Outcome|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
1246770|NCT00102063|O3|Outcome|Placebo Group|Participants were given a single pill administered once daily
1246771|NCT00102063|O2|Outcome|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
1246772|NCT00102063|O1|Outcome|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
1246773|NCT00102063|O3|Outcome|Placebo Group|Participants were given a single pill administered once daily
1246774|NCT00102063|O2|Outcome|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
1246775|NCT00102063|O1|Outcome|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
1246777|NCT00102063|O2|Outcome|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
1246778|NCT00102063|O1|Outcome|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
1246779|NCT00102063|O3|Outcome|Placebo Group|Participants were given a single pill administered once daily
1246780|NCT00102063|O2|Outcome|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
1246781|NCT00102063|O1|Outcome|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
1246782|NCT00102063|E3|Reported Event|Placebo Group|Participants were given a single pill administered once daily
1246783|NCT00102063|E2|Reported Event|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
1246784|NCT00102063|E1|Reported Event|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
1246785|NCT00101933|B3|Baseline|Total|Total of all reporting groups
1246786|NCT00101933|B2|Baseline|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
1246787|NCT00101933|B1|Baseline|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
1246788|NCT00101933|P2|Participant Flow|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
1246789|NCT00101933|P1|Participant Flow|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
1246790|NCT00101933|O2|Outcome|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
1246791|NCT00101933|O1|Outcome|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
1246792|NCT00101933|O2|Outcome|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
1246793|NCT00101933|O1|Outcome|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
1246794|NCT00101933|O2|Outcome|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
1246795|NCT00101933|O1|Outcome|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
1246796|NCT00101933|O2|Outcome|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
1246797|NCT00101933|O1|Outcome|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
1246798|NCT00101933|O2|Outcome|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
1246799|NCT00101933|O1|Outcome|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
1246800|NCT00101933|O2|Outcome|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
1246801|NCT00101933|O1|Outcome|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
1246802|NCT00101933|O1|Outcome|All Implanted Subjects|This group contains all subjects who were implanted. This includes one additional subject over those that were randomized.
1246803|NCT00101933|O1|Outcome|All Implanted Subjects|This group contains all subjects who were implanted. This includes one additional subject over those that were randomized.
1246804|NCT00101933|O2|Outcome|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
1246805|NCT00101933|O1|Outcome|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
1246806|NCT00101933|E2|Reported Event|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
1246807|NCT00101933|E1|Reported Event|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
1246808|NCT00101907|B7|Baseline|Total|Total of all reporting groups
1246809|NCT00101907|B6|Baseline|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246810|NCT00101907|B5|Baseline|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246811|NCT00101907|B4|Baseline|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246812|NCT00101907|B3|Baseline|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246813|NCT00101907|B2|Baseline|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246814|NCT00101907|B1|Baseline|Panitumumab + Gem/Cis|Panitumumab 9 mg/kg on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle.
1246815|NCT00101907|P6|Participant Flow|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246816|NCT00101907|P5|Participant Flow|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246817|NCT00101907|P4|Participant Flow|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246818|NCT00101907|P3|Participant Flow|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246819|NCT00101907|P2|Participant Flow|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246820|NCT00101907|P1|Participant Flow|Panitumumab + Gem/Cis|Panitumumab 9 mg/kg intravenously (IV) on Day 1 + gemcitabine (gem) 1250 mg/m^2 IV on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 IV on Day 1 of each 3-week cycle.
1246821|NCT00101907|O6|Outcome|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246822|NCT00101907|O5|Outcome|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246823|NCT00101907|O4|Outcome|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246824|NCT00101907|O3|Outcome|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246825|NCT00101907|O2|Outcome|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246826|NCT00101907|O1|Outcome|Panitumumab + Gem/Cis|Panitumumab 9 mg/kg intravenously (IV) on Day 1 + gemcitabine (gem) 1250 mg/m^2 IV on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 IV on Day 1 of each 3-week cycle.
1246827|NCT00101907|O5|Outcome|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246828|NCT00101907|O4|Outcome|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246985|NCT00101686|E1|Reported Event|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
1246986|NCT00101660|B3|Baseline|Total|Total of all reporting groups
1246829|NCT00101907|O3|Outcome|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246830|NCT00101907|O2|Outcome|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246831|NCT00101907|O1|Outcome|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246832|NCT00101907|O5|Outcome|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246833|NCT00101907|O4|Outcome|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246834|NCT00101907|O3|Outcome|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246835|NCT00101907|O2|Outcome|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246836|NCT00101907|O1|Outcome|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246837|NCT00101907|O5|Outcome|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246838|NCT00101907|O4|Outcome|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246839|NCT00101907|O3|Outcome|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246840|NCT00101907|O2|Outcome|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246841|NCT00101907|O1|Outcome|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246842|NCT00101907|O5|Outcome|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246843|NCT00101907|O4|Outcome|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246844|NCT00101907|O3|Outcome|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246845|NCT00101907|O2|Outcome|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246846|NCT00101907|O1|Outcome|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246847|NCT00101907|O6|Outcome|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246848|NCT00101907|O5|Outcome|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246849|NCT00101907|O4|Outcome|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246850|NCT00101907|O3|Outcome|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246851|NCT00101907|O2|Outcome|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246852|NCT00101907|O1|Outcome|Panitumumab + Gem/Cis|Panitumumab 9 mg/kg intravenously (IV) on Day 1 + gemcitabine (gem) 1250 mg/m^2 IV on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 IV on Day 1 of each 3-week cycle.
1246853|NCT00101907|E6|Reported Event|75 mg BID AMG 706 + Panitumumab + Gem/CisEdit|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246854|NCT00101907|E5|Reported Event|125 mg QD AMG 706 + Panitumumab + Gem/CisEdit|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246855|NCT00101907|E4|Reported Event|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246856|NCT00101907|E3|Reported Event|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246857|NCT00101907|E2|Reported Event|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
1246858|NCT00101907|E1|Reported Event|Panitumumab + Gem/Cis|Panitumumab 9 mg/kg intravenously (IV) on Day 1 + gemcitabine (gem) 1250 mg/m^2 IV on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 IV on Day 1 of each 3-week cycle.
1246859|NCT00101868|B3|Baseline|Total|Total of all reporting groups
1246860|NCT00101868|B2|Baseline|Usual Care Discharge Process|Hospital physicians and ward nurses completed handwritten discharge forms on the day of discharge. The forms contained blanks for discharge diagnoses, discharge medications, medication instructions, post discharge activities and restrictions, post discharge diet, post discharge diagnostic and therapeutic interventions, and appointments. Patients received handwritten copies of the forms, one page of which also included medication instructions and prescriptions
1246861|NCT00101868|B1|Baseline|Discharge Communication Software|Computerized-Physician-Order-Entry software application to facilitate communication at time of hospital discharge to patients, retail pharmacists, community physicians. Software had required fields, pick lists, standard drug doses, alerts, reminders, online reference information. Software prompted discharging physician to enter pending tests, order tests after discharge. Hospital physicians used software on day of discharge to generate four documents automatically: personalized letter to outpatient physician, legible prescriptions, and legible discharge order
1246862|NCT00101868|P2|Participant Flow|Usual Care Discharge Process|Hospital physicians and ward nurses completed handwritten discharge forms on the day of discharge. The forms contained blanks for discharge diagnoses, discharge medications, medication instructions, post discharge activities and restrictions, post discharge diet, post discharge diagnostic and therapeutic interventions, and appointments. Patients received handwritten copies of the forms, one page of which also included medication instructions and prescriptions
1246863|NCT00101868|P1|Participant Flow|Discharge Communication Software|Computerized-Physician-Order-Entry software application to facilitate communication at time of hospital discharge to patients, retail pharmacists, community physicians. Software had required fields, pick lists, standard drug doses, alerts, reminders, online reference information. Software prompted discharging physician to enter pending tests, order tests after discharge. Hospital physicians used software on day of discharge to generate four documents automatically: personalized letter to outpatient physician, legible prescriptions, and legible discharge order
1246937|NCT00101686|P6|Participant Flow|CapeIRI + Placebo|Irinotecan plus capecitabine (CapeIRI) with placebo
1246938|NCT00101686|P5|Participant Flow|CapeIRI + Celecoxib|Irinotecan plus capecitabine (CapeIRI) with celecoxib
1246864|NCT00101868|O2|Outcome|Usual Care Discharge Process|Hospital physicians and ward nurses completed handwritten discharge forms on the day of discharge. The forms contained blanks for discharge diagnoses, discharge medications, medication instructions, post discharge activities and restrictions, post discharge diet, post discharge diagnostic and therapeutic interventions, and appointments. Patients received handwritten copies of the forms, one page of which also included medication instructions and prescriptions
1246865|NCT00101868|O1|Outcome|Discharge Communication Software|Computerized-Physician-Order-Entry software application to facilitate communication at time of hospital discharge to patients, retail pharmacists, community physicians. Software had required fields, pick lists, standard drug doses, alerts, reminders, online reference information. Software prompted discharging physician to enter pending tests, order tests after discharge. Hospital physicians used software on day of discharge to generate four documents automatically: personalized letter to outpatient physician, legible prescriptions, and legible discharge order
1246866|NCT00101868|O2|Outcome|Usual Care Discharge Process|Hospital physicians and ward nurses completed handwritten discharge forms on the day of discharge. The forms contained blanks for discharge diagnoses, discharge medications, medication instructions, post discharge activities and restrictions, post discharge diet, post discharge diagnostic and therapeutic interventions, and appointments. Patients received handwritten copies of the forms, one page of which also included medication instructions and prescriptions
1246867|NCT00101868|O1|Outcome|Discharge Communication Software|Computerized-Physician-Order-Entry software application to facilitate communication at time of hospital discharge to patients, retail pharmacists, community physicians. Software had required fields, pick lists, standard drug doses, alerts, reminders, online reference information. Software prompted discharging physician to enter pending tests, order tests after discharge. Hospital physicians used software on day of discharge to generate four documents automatically: personalized letter to outpatient physician, legible prescriptions, and legible discharge order
1246868|NCT00101868|O2|Outcome|Usual Care Discharge, Handwritten|The control intervention was the usual care discharge process. Hospital physicians and ward nurses completed handwritten discharge forms on the day of discharge. The forms contained blanks for discharge diagnoses, discharge medications, medication instructions, post-discharge activities and restrictions, post-discharge diet, post-discharge diagnostic and therapeutic interventions, and appointments. Patients received handwritten copies of the forms, 1 page of which also included medication instructions and prescriptions.
1246869|NCT00101868|O1|Outcome|Discharge Software|Software is computerized-physician-order-entry application for communication at time of hospital discharge to patients, retail pharmacists, and community physicians. Software features included required fields, pick lists, standard drug doses, alerts, reminders, and online reference information. Software prompted discharging physician to enter pending tests and order tests after discharge. Hospital physicians used software on day of discharge and automatically generated 4 discharge documents: personalized letter to outpatient physician with discharge diagnoses, reconciled medication list, diet-activity instructions, patient education materials provided, and follow-up appointments-studies; printed legible prescriptions with information for dispensing pharmacist about changes-deletions in patient's previous regimen; patient instructions with addresses and telephone numbers for follow-up appointments and tests; and printed legible discharge order with aforementioned information.
1246870|NCT00101868|E2|Reported Event|Usual Care Discharge Process|Hospital physicians and ward nurses completed handwritten discharge forms on the day of discharge. The forms contained blanks for discharge diagnoses, discharge medications, medication instructions, post discharge activities and restrictions, post discharge diet, post discharge diagnostic and therapeutic interventions, and appointments. Patients received handwritten copies of the forms, one page of which also included medication instructions and prescriptions
1246871|NCT00101868|E1|Reported Event|Discharge Communication Software|Computerized-Physician-Order-Entry software application to facilitate communication at time of hospital discharge to patients, retail pharmacists, community physicians. Software had required fields, pick lists, standard drug doses, alerts, reminders, online reference information. Software prompted discharging physician to enter pending tests, order tests after discharge. Hospital physicians used software on day of discharge to generate four documents automatically: personalized letter to outpatient physician, legible prescriptions, and legible discharge order
1246872|NCT00101816|B3|Baseline|Total|Total of all reporting groups
1246873|NCT00101816|B2|Baseline|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
1246874|NCT00101816|B1|Baseline|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
1246939|NCT00101686|P4|Participant Flow|mIFL + Placebo|Modified irinotecan plus bolus 5-FU/LV (mIFL) with placebo
1246940|NCT00101686|P3|Participant Flow|mIFL + Celecoxib|Modified irinotecan plus bolus 5-FU/LV (mIFL) with celecoxib
1246941|NCT00101686|P2|Participant Flow|FOLFIRI + Placebo|Irinotecan plus infusional 5-FU/LV (FOLFIRI) with placebo
1246942|NCT00101686|P1|Participant Flow|FOLFIRI + Celecoxib|Irinotecan plus infusional 5-Fluorouracil(5-FU)/Leucovorin(LV) (FOLFIRI) with celecoxib
1246943|NCT00101686|O5|Outcome|Bevacizumab + mIRI|Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
1246944|NCT00101686|O4|Outcome|Bevacizumab + FOLFIRI|Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
1246945|NCT00101686|O3|Outcome|CapeIRI|Irinotecan + oral capecitabine with celecoxib or placebo
1246875|NCT00101816|P2|Participant Flow|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
1246876|NCT00101816|P1|Participant Flow|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
1246877|NCT00101816|O3|Outcome|Total|
1246878|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
1246879|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
1246880|NCT00101816|O2|Outcome|Study Day 8|
1246881|NCT00101816|O1|Outcome|Study Day 1|
1246882|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
1246883|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
1246884|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
1246885|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
1246886|NCT00101816|O2|Outcome|Study Day 8|
1246887|NCT00101816|O1|Outcome|Study Day 1|
1246888|NCT00101816|O2|Outcome|Study Day 8|
1246889|NCT00101816|O1|Outcome|Study Day 1|
1246890|NCT00101816|O2|Outcome|Study Day 8|
1246891|NCT00101816|O1|Outcome|Study Day 1|
1246892|NCT00101816|O2|Outcome|Study Day 8|
1246893|NCT00101816|O1|Outcome|Study Day 1|
1246894|NCT00101816|O2|Outcome|Study Day 8|
1246895|NCT00101816|O1|Outcome|Study Day 1|
1246896|NCT00101816|O3|Outcome|Total|
1246946|NCT00101686|O2|Outcome|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
1246947|NCT00101686|O1|Outcome|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
1246948|NCT00101686|O5|Outcome|Bevacizumab + mIRI|Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
1246949|NCT00101686|O4|Outcome|Bevacizumab + FOLFIRI|Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
1246897|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
1246898|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
1246899|NCT00101816|O3|Outcome|Total|
1246900|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
1246901|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
1246902|NCT00101816|O2|Outcome|MCyR|Participants acheiving MCyR, defined as the rate of CCyR plus the rate of Partial Cytogenetic Response
1246903|NCT00101816|O1|Outcome|MaHR|Participants acheiving MaHR, defined as best confirmed response of Complete Hematologic Response (CHR) or No Evidence of Leukemia (NEL) of Minore Hematologic Response (MiHR)
1246904|NCT00101816|O3|Outcome|Total|
1246919|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
1247107|NCT00101413|B1|Baseline|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
1246905|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
1246906|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
1246907|NCT00101816|O3|Outcome|Total|
1246908|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
1246909|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
1246910|NCT00101816|O3|Outcome|Total|
1246950|NCT00101686|O3|Outcome|CapeIRI|Irinotecan + oral capecitabine with celecoxib or placebo
1246951|NCT00101686|O2|Outcome|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
1246952|NCT00101686|O1|Outcome|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
1246953|NCT00101686|O2|Outcome|Bevacizumab + mIRI|Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
1246954|NCT00101686|O1|Outcome|Bevacizumab + FOLFIRI|Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
1246955|NCT00101686|O2|Outcome|Bevacizumab + mIRI|Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
1246911|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
1246912|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
1246913|NCT00101816|O2|Outcome|Participants Acheiving OHR|OHR=best confirmed response of major or minor hematologic response (MaHR or MiHR).
1246914|NCT00101816|O1|Outcome|Participants Acheiving MaHR|MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL)
1246915|NCT00101816|O1|Outcome|Participants Acheiving OHR|OHR=best confirmed response of major or minor hematologic response
1246916|NCT00101816|O1|Outcome|Participants Acheiving MaHR|MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL)
1246917|NCT00101816|O3|Outcome|Total|
1246918|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
1246983|NCT00101686|E3|Reported Event|CapeIRI|Irinotecan + oral capecitabine with celecoxib or placebo
1246984|NCT00101686|E2|Reported Event|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
1246920|NCT00101816|E2|Reported Event|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
1246921|NCT00101816|E1|Reported Event|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
1246922|NCT00101686|B11|Baseline|Total|Total of all reporting groups
1246923|NCT00101686|B10|Baseline|Bevacizumab + mIFL + Placebo|Bevacizumab + Modified irinotecan plus bolus 5-FU/LV (mIFL)with placebo
1246924|NCT00101686|B9|Baseline|Bevacizumab + mIFL + Celecoxib|Bevacizumab + Modified irinotecan plus bolus 5-FU/LV (mIFL) with celecoxib
1246925|NCT00101686|B8|Baseline|Bevacizumab + FOLFIRI + Placebo|Bevacizumab + Irinotecan plus infusional 5-FU/LV (FOLFIRI) with placebo
1246926|NCT00101686|B7|Baseline|Bevacizumab + FOLFIRI + Celecoxib|Bevacizumab + Irinotecan plus infusional 5-FU/LV (FOLFIRI) with celecoxib
1246927|NCT00101686|B6|Baseline|CapeIRI + Placebo|Irinotecan plus capecitabine (CapeIRI) with placebo
1246928|NCT00101686|B5|Baseline|CapeIRI + Celecoxib|Irinotecan plus capecitabine (CapeIRI) with celecoxib
1246929|NCT00101686|B4|Baseline|mIFL + Placebo|Modified irinotecan plus bolus 5-FU/LV (mIFL) with placebo
1246930|NCT00101686|B3|Baseline|mIFL + Celecoxib|Modified irinotecan plus bolus 5-FU/LV (mIFL) with celecoxib
1246931|NCT00101686|B2|Baseline|FOLFIRI + Placebo|Irinotecan plus infusional 5-FU/LV (FOLFIRI) with placebo
1246932|NCT00101686|B1|Baseline|FOLFIRI + Celecoxib|Irinotecan plus infusional 5-Fluorouracil(5-FU)/Leucovorin(LV) (FOLFIRI) with celecoxib
1246933|NCT00101686|P10|Participant Flow|Bevacizumab + mIFL + Placebo|Bevacizumab + Modified irinotecan plus bolus 5-FU/LV (mIFL)with placebo
1246934|NCT00101686|P9|Participant Flow|Bevacizumab + mIFL + Celecoxib|Bevacizumab + Modified irinotecan plus bolus 5-FU/LV (mIFL) with celecoxib
1246935|NCT00101686|P8|Participant Flow|Bevacizumab + FOLFIRI + Placebo|Bevacizumab + Irinotecan plus infusional 5-FU/LV (FOLFIRI) with placebo
1246936|NCT00101686|P7|Participant Flow|Bevacizumab + FOLFIRI + Celecoxib|Bevacizumab + Irinotecan plus infusional 5-FU/LV (FOLFIRI) with celecoxib
1247036|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
1246956|NCT00101686|O1|Outcome|Bevacizumab + FOLFIRI|Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
1246957|NCT00101686|O2|Outcome|Bevacizumab + mIFL|Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
1246958|NCT00101686|O1|Outcome|Bevacizumab + FOLFIRI|Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
1246959|NCT00101686|O2|Outcome|Bevacizumab + mIFL|Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
1246960|NCT00101686|O1|Outcome|Bevacizumab + FOLFIRI|Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
1246961|NCT00101686|O2|Outcome|Placebo|All patients treated with placebo: combined patients treated with FOLFIRI+placebo, mIRI+placebo, CapeIRI+placebo
1246962|NCT00101686|O1|Outcome|Celecoxib|All patients treated with celecoxib: combined patients treated with FOLFIRI+ celecoxib, mIRI+ celecoxib, CapeIRI+ celecoxib
1246963|NCT00101686|O2|Outcome|Placebo|All patients treated with placebo: combined patients treated with FOLFIRI+placebo, mIRI+placebo, CapeIRI+placebo
1246964|NCT00101686|O1|Outcome|Celecoxib|All patients treated with celecoxib: combined patients treated with FOLFIRI+ celecoxib, mIRI+ celecoxib, CapeIRI+ celecoxib
1246965|NCT00101686|O2|Outcome|Placebo|All patients treated with placebo: combined patients treated with FOLFIRI+placebo, mIRI+placebo, CapeIRI+placebo
1246966|NCT00101686|O1|Outcome|Celecoxib|All patients treated with celecoxib: combined patients treated with FOLFIRI+ celecoxib, mIRI+ celecoxib, CapeIRI+ celecoxib
1246967|NCT00101686|O3|Outcome|CapeIRI|Irinotecan + oral capecitabine with celecoxib or placebo
1246968|NCT00101686|O2|Outcome|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
1246969|NCT00101686|O1|Outcome|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
1246970|NCT00101686|O3|Outcome|CapeIRI|Irinotecan + oral capecitabine with celecoxib or placebo
1246971|NCT00101686|O2|Outcome|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
1246972|NCT00101686|O1|Outcome|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
1246973|NCT00101686|O3|Outcome|CapeIRI|Irinotecan + oral capecitabine with celecoxib or placebo
1246974|NCT00101686|O2|Outcome|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
1246975|NCT00101686|O1|Outcome|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
1246976|NCT00101686|O3|Outcome|CapeIRI|Irinotecan + oral capecitabine with celecoxib or placebo
1246977|NCT00101686|O2|Outcome|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
1246978|NCT00101686|O1|Outcome|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
1246979|NCT00101686|O2|Outcome|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
1246980|NCT00101686|O1|Outcome|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
1246981|NCT00101686|E5|Reported Event|Bevacizumab + mIRI|Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
1246982|NCT00101686|E4|Reported Event|Bevacizumab + FOLFIRI|Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
1246987|NCT00101660|B2|Baseline|Imatinib-resistant|Imatinib resistance, acquired or primary. Acquired resistance: participants who achieve major cytogenetic response (MCyR) or complete hematologic response (CHR) on imatinib at any dose prior to progression, defined by 1 of the following: loss of MCyR, loss of CHR, or increasing white blood cell (WBC) count. Primary resistance: participants who never achieve MCyR or CHR at any dose, and meet 1 of the following: continuously increasing WBC count on at least 2 consecutive evaluations at least 2 weeks apart, with the final assessment showing a doubling of WBC from nadir to ≥20,000/mm^3; an absolute increase in WBC by more than 50,000/mm^3 above lowest count after starting imatinib; no CHR after 3 months; no cytogenetic response (CyR) after 6 months; or no MCyR after 12 months. Resistance was also defined as chronic myeloid leukemia (CML) with resistance to imatinib ≤600mg/d with genetic mutation in BCR-ABL gene (L248V, G250E, Q252H/R, Y253H/F, E255K/V, T315I/D, F317L, H369P/R).
1246988|NCT00101660|B1|Baseline|Imatinib-intolerant|Imatinib intolerance was defined as: Grade 3 or greater nonhematologic toxicity that is imatinib-related or Grade 4 hematologic toxicity that is imatinib-related lasting more than 7 days.
1246989|NCT00101660|P2|Participant Flow|Imatinib-resistant|Imatinib resistance, acquired or primary. Acquired resistance: participants who achieve major cytogenetic response (MCyR) or complete hematologic response (CHR) on imatinib at any dose prior to progression, defined by 1 of the following: loss of MCyR, loss of CHR, or increasing white blood cell (WBC) count. Primary resistance: participants who never achieve MCyR or CHR at any dose, and meet 1 of the following: continuously increasing WBC count on at least 2 consecutive evaluations at least 2 weeks apart, with the final assessment showing a doubling of WBC from nadir to ≥20,000/mm^3; an absolute increase in WBC by more than 50,000/mm^3 above lowest count after starting imatinib; no CHR after 3 months; no cytogenetic response (CyR) after 6 months; or no MCyR after 12 months. Resistance was also defined as chronic myeloid leukemia (CML) with resistance to imatinib ≤600mg/d with genetic mutation in BCR-ABL gene (L248V, G250E, Q252H/R, Y253H/F, E255K/V, T315I/D, F317L, H369P/R).
1246990|NCT00101660|P1|Participant Flow|Imatinib-intolerant|Imatinib intolerance was defined as: Grade 3 or greater nonhematologic toxicity that is imatinib-related or Grade 4 hematologic toxicity that is imatinib-related lasting more than 7 days.
1246991|NCT00101660|O1|Outcome|Dasatinib|Dasatanib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
1246992|NCT00101660|O1|Outcome|Dasatinib,70 mg BID|"Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.~a"
1246993|NCT00101660|O1|Outcome|Dasatinib,70 mg BID|Dasatanib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
1247037|NCT00101647|O3|Outcome|Total|
1247038|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
1246994|NCT00101660|O1|Outcome|Dasatinib,70 mg BID|Dasatanib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
1246995|NCT00101660|O1|Outcome|Dasatinib, 70 mg BID|Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
1246996|NCT00101660|O1|Outcome|Dasatinib, 70 mg BID|Dasatinib, 70 mg twice BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
1246997|NCT00101660|O1|Outcome|Dasatinib,70 mg BID|Dasatanib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
1246998|NCT00101660|O1|Outcome|Dasatinib, 70 mg BID|Dasatinib, 70 mg twice BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
1246999|NCT00101660|O1|Outcome|Dasatinib, 70 mg BID|Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
1247000|NCT00101660|O1|Outcome|Dasatanib, 70 mg BID|Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
1247001|NCT00101660|O1|Outcome|Dastinib, 70 mg, BID|Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
1247002|NCT00101660|O1|Outcome|Dasatinib, 70 mg, Twice Daily (BID)|Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
1247003|NCT00101660|E2|Reported Event|Resistant|
1247004|NCT00101660|E1|Reported Event|Intolerant|
1247005|NCT00101647|B3|Baseline|Total|Total of all reporting groups
1247006|NCT00101647|B2|Baseline|Imatinib-resistant|Defined as any of the following: i) initial diagnosis of chronic phase of chronic myeloid leukemia (CML) that progressed to accelerated phase while on treatment with imatinib ≥ 400 mg/day (primary or acquired resistance); ii) initial diagnosis of accelerated phase CML and failure to achieve a hematologic response after ≥ 4 weeks (or ≥ 2 weeks for subjects showing rapid disease progression) of imatinib ≥ 600 mg/day; the required prior imatinib dose was 400 to < 600 mg/day if the subject was intolerant to ≥ 600 mg/day (primary resistance); iii) initial diagnosis of accelerated or blast phase CML that progressed to accelerated phase CML following an initial hematologic response to imatinib ≥ 600 mg/day (acquired resistance). The required prior imatinib dose was 400 to < 600 mg/day if the subject was intolerant of ≥ 600 mg/day.
1247007|NCT00101647|B1|Baseline|Imatinib-intolerant|Defined as either: i) toxicity that was considered at least possibly related to imatinib ≤ 400 mg/day that led to a discontinuation of imatinib therapy; ii) ability to tolerate only < 400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses, was not considered imatinib-tolerant.
1247065|NCT00101582|O2|Outcome|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
1247008|NCT00101647|P2|Participant Flow|Imatinib-resistant|Defined as any of the following: i) initial diagnosis of chronic phase of chronic myeloid leukemia (CML) that progressed to accelerated phase while on treatment with imatinib ≥ 400 mg/day (primary or acquired resistance); ii) initial diagnosis of accelerated phase CML and failure to achieve a hematologic response after ≥ 4 weeks (or ≥ 2 weeks for subjects showing rapid disease progression) of imatinib ≥ 600 mg/day; the required prior imatinib dose was 400 to < 600 mg/day if the subject was intolerant to ≥ 600 mg/day (primary resistance); iii) initial diagnosis of accelerated or blast phase CML that progressed to accelerated phase CML following an initial hematologic response to imatinib ≥ 600 mg/day (acquired resistance). The required prior imatinib dose was 400 to < 600 mg/day if the subject was intolerant of ≥ 600 mg/day.
1247009|NCT00101647|P1|Participant Flow|Imatinib-intolerant|Defined as either: i) toxicity that was considered at least possibly related to imatinib ≤ 400 mg/day that led to a discontinuation of imatinib therapy; ii) ability to tolerate only < 400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses, was not considered imatinib-tolerant.
1247010|NCT00101647|O3|Outcome|Total|
1247011|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
1247012|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
1247013|NCT00101647|O2|Outcome|Day 8|
1247014|NCT00101647|O1|Outcome|Day 1|
1247015|NCT00101647|O2|Outcome|Day 8|
1247016|NCT00101647|O1|Outcome|Day 1|
1247017|NCT00101647|O2|Outcome|Day 8|
1247018|NCT00101647|O1|Outcome|Day 1|
1247019|NCT00101647|O2|Outcome|Study Day 8|
1247020|NCT00101647|O1|Outcome|Study Day 1|
1247021|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
1247022|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg BID
1247023|NCT00101647|O3|Outcome|Total|
1247024|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
1247025|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
1247026|NCT00101647|O2|Outcome|Participants Achieving MCyR|Percentage of participants achieving major cytogenetic response (MCyR), defined as the rate of complete cytogenetic response (CCyR) plus the rate of partial cytogenetic response (PCyR).
1247027|NCT00101647|O1|Outcome|Participants Achieving MaHR|Percentage of participants achieving MaHR, defined as best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL)
1247028|NCT00101647|O3|Outcome|Total|
1247029|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
1247030|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
1247031|NCT00101647|O3|Outcome|Total|
1247032|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
1247033|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
1247034|NCT00101647|O3|Outcome|Total|
1247035|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
1247041|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
1247042|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
1247043|NCT00101647|O3|Outcome|Total|
1247044|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
1247045|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
1247046|NCT00101647|O2|Outcome|Total|
1247047|NCT00101647|O1|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
1247048|NCT00101647|O3|Outcome|Total|
1247049|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
1247050|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg BID
1247051|NCT00101647|O3|Outcome|Total|
1247052|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
1247053|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
1247054|NCT00101647|E2|Reported Event|Resistant|
1247055|NCT00101647|E1|Reported Event|Intolerant|
1247056|NCT00101582|B3|Baseline|Total|Total of all reporting groups
1247057|NCT00101582|B2|Baseline|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
1247058|NCT00101582|B1|Baseline|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
1247059|NCT00101582|P2|Participant Flow|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course. Chemotherapy consisted of 100 mg/m^2 cisplatin administered by IV infusion on Days 1, 22, and 43.
1247060|NCT00101582|P1|Participant Flow|Placebo|Participants received a single intravenous (IV) dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course. Chemotherapy consisted of 100 mg/m^2 cisplatin administered by IV infusion on Days 1, 22, and 43.
1247061|NCT00101582|O2|Outcome|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
1247062|NCT00101582|O1|Outcome|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
1247063|NCT00101582|O2|Outcome|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
1247064|NCT00101582|O1|Outcome|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
1247788|NCT00098345|O1|Outcome|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
1247066|NCT00101582|O1|Outcome|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
1247067|NCT00101582|O2|Outcome|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
1247068|NCT00101582|O1|Outcome|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
1247069|NCT00101582|O2|Outcome|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
1247070|NCT00101582|O1|Outcome|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
1247071|NCT00101582|O2|Outcome|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
1247072|NCT00101582|O1|Outcome|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
1247073|NCT00101582|O2|Outcome|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
1247074|NCT00101582|O1|Outcome|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
1247075|NCT00101582|O2|Outcome|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
1247076|NCT00101582|O1|Outcome|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
1247077|NCT00101582|E2|Reported Event|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
1247078|NCT00101582|E1|Reported Event|Placebo|Participants received a single intravenous (IV) dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
1247079|NCT00101452|B4|Baseline|Total|Total of all reporting groups
1247080|NCT00101452|B3|Baseline|3. Placebo|Sugar Pill- contains no active ingrediants
1247081|NCT00101452|B2|Baseline|2. Escitalopram|A selective serotonin reuptake inhibitor (SSRI)
1247082|NCT00101452|B1|Baseline|1. SAMe|a naturally occurring substance
1247083|NCT00101452|P3|Participant Flow|3. Placebo|Placebo is a non-active treatment, sometimes called a sugar pill.
1247084|NCT00101452|P2|Participant Flow|2. Escitalopram|Patients start with 10mg/day for the first 6 weeks. If they do not feel better after 6 weeks, they can increase to 20mg/day.
1247085|NCT00101452|P1|Participant Flow|1. SAMe|Patients start with 1600mg/day for the first. If they do not feel better after 6 weeks, they may increase to 3200mg/day if their lab tests are normal.
1247086|NCT00101452|O3|Outcome|3. Placebo|Sugar Pill- contains no active ingrediants
1247087|NCT00101452|O2|Outcome|2. Escitalopram|A selective serotonin reuptake inhibitor (SSRI)
1247088|NCT00101452|O1|Outcome|1. SAMe|a naturally occurring substance
1247089|NCT00101452|E7|Reported Event|7. SAMe Plus Escitalopram (Weeks 12-24, Cross-over)|A naturally occurring substance (S-adenosyl methionine) plus a selective serotonin reuptake inhibitor (SSRI)
1247090|NCT00101452|E6|Reported Event|6. Placebo (Weeks 12-24, Continuation)|Sugar Pill- contains no active ingredients
1247091|NCT00101452|E5|Reported Event|5. Escitalopram (Weeks 12-24, Continuation)|A selective serotonin reuptake inhibitor (SSRI)
1247092|NCT00101452|E4|Reported Event|4. SAMe (Weeks 12-24, Continuation)|A naturally occurring substance (S-adenosyl methionine)
1247093|NCT00101452|E3|Reported Event|3. Placebo (Weeks 1-12)|Sugar Pill- contains no active ingredients
1247094|NCT00101452|E2|Reported Event|2. Escitalopram (Weeks 1-12)|A selective serotonin reuptake inhibitor (SSRI)
1247095|NCT00101452|E1|Reported Event|1. SAMe (Weeks 1-12)|A naturally occurring substance (S-adenosyl methionine)
1247096|NCT00101439|B3|Baseline|Total|Total of all reporting groups
1247097|NCT00101439|B2|Baseline|Placebo→ Ezetimibe|After a 2-week single- blind placebo run-in, participants will receive placebo once daily for 4 weeks and then receive ezetimibe10 mg once daily for 4 weeks.
1247098|NCT00101439|B1|Baseline|Ezetimibe→Placebo|After a 2-week single- blind placebo run-in, participants will receive ezetimibe 10 mg once daily for 4 weeks and then receive placebo once daily for 4 weeks.
1247099|NCT00101439|P2|Participant Flow|Placebo→ Ezetimibe|After a 2-week single- blind placebo run-in, participants will receive placebo once daily for 4 weeks and then receive ezetimibe10 mg once daily for 4 weeks.
1247100|NCT00101439|P1|Participant Flow|Ezetimibe→Placebo|After a 2-week single- blind placebo run-in, participants will receive ezetimibe 10 mg once daily for 4 weeks and then receive placebo once daily for 4 weeks.
1247101|NCT00101439|O2|Outcome|Placebo|Participants who received placebo in active treatment period regardless of randomly assigned sequence
1247102|NCT00101439|O1|Outcome|Ezetimibe|Participants who received ezetimibe 10 mg in active treatment period regardless of randomly assigned sequence
1247103|NCT00101439|O2|Outcome|Placebo|Participants who received placebo in active treatment period regardless of randomly assigned sequence
1247104|NCT00101439|O1|Outcome|Ezetimibe|Participants who received ezetimibe 10 mg in active treatment period regardless of randomly assigned sequence
1247105|NCT00101439|E2|Reported Event|Placebo|Participants received placebo once daily for 4 weeks
1247106|NCT00101439|E1|Reported Event|Ezetimibe|Participants received 10 mg ezetimibe once daily for 4 weeks
1247108|NCT00101413|P1|Participant Flow|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
1247109|NCT00101413|O1|Outcome|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
1247110|NCT00101413|O1|Outcome|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
1247111|NCT00101413|O1|Outcome|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
1247112|NCT00101413|O1|Outcome|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
1247113|NCT00101413|O1|Outcome|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
1247114|NCT00101413|E1|Reported Event|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
1247115|NCT00101400|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
1247116|NCT00101400|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
1247117|NCT00101400|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
1247118|NCT00101400|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
1247119|NCT00101400|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
1247120|NCT00101400|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
1247121|NCT00101400|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
1247122|NCT00101400|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
1247123|NCT00101400|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
1247124|NCT00101361|B3|Baseline|Total|Total of all reporting groups
1247125|NCT00101361|B2|Baseline|Placebo|placebo
1247126|NCT00101361|B1|Baseline|Oxandrolone|Oxandrolone
1247127|NCT00101361|P2|Participant Flow|2 Placebo|placebo - two capsules twice daily
1247128|NCT00101361|P1|Participant Flow|1 Oxandrolone|oxandrolone - two 5mg capsules twice daily
1247129|NCT00101361|O2|Outcome|2 Placebo|placebo - two capsules twice daily
1247130|NCT00101361|O1|Outcome|1 Oxandrolone|oxandrolone - two 5mg capsules twice daily
1247131|NCT00101361|E2|Reported Event|2 Placebo|placebo - two capsules twice daily
1247132|NCT00101361|E1|Reported Event|1 Oxandrolone|oxandrolone - two 5mg capsules twice daily
1247133|NCT00101283|B3|Baseline|Total|Total of all reporting groups
1247134|NCT00101283|B2|Baseline|Pemetrexed/Gemcitabine|Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
1247135|NCT00101283|B1|Baseline|Pemetrexed/Carboplatin|Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
1247136|NCT00101283|P2|Participant Flow|Pemetrexed/Gemcitabine|Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
1247137|NCT00101283|P1|Participant Flow|Pemetrexed/Carboplatin|Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
1247138|NCT00101283|O2|Outcome|Pemetrexed/Gemcitabine|Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
1247139|NCT00101283|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
1247140|NCT00101283|O2|Outcome|Pemetrexed/Gemcitabine|Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
1247141|NCT00101283|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
1247142|NCT00101283|O2|Outcome|Pemetrexed/Gemcitabine|Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
1247143|NCT00101283|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
1247144|NCT00101283|E2|Reported Event|Pemetrexed/Gemcitabine|Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
1247145|NCT00101283|E1|Reported Event|Pemetrexed/Carboplatin|Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
1247146|NCT00101192|B1|Baseline|Cetuximab|Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy.
1247147|NCT00101192|P1|Participant Flow|Cetuximab|Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy.
1247148|NCT00101192|O1|Outcome|Cetuximab|Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy.
1247149|NCT00101192|E1|Reported Event|Cetuximab|Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy.
1247150|NCT00101166|B1|Baseline|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.~Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
1247789|NCT00098345|O1|Outcome|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
1247151|NCT00101166|P1|Participant Flow|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.~Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
1247152|NCT00101166|O1|Outcome|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.~Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
1247153|NCT00101166|O1|Outcome|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.~Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
1247154|NCT00101166|O1|Outcome|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.~Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
1247155|NCT00101166|O1|Outcome|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.~Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
1247156|NCT00101166|O1|Outcome|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.~Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
1247157|NCT00101166|E1|Reported Event|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.~Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
1247185|NCT00100932|O1|Outcome|E7389 28 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
1247476|NCT00099437|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
1247158|NCT00101101|B1|Baseline|Vaccine and Conventional Therapy|"Patients were treated with 3-6 cycles of chemotherapy +/- rituximab, with type and duration at the discretion of the individual clinician.~Chemotherapy: 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.~Patients who achieve a partial or complete response after completion of chemotherapy proceed to autologous tumor cell-based vaccine therapy.~Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2.~Treatment continues in the absence of disease progression or unacceptable toxicity."
1247159|NCT00101101|P1|Participant Flow|Vaccine and Conventional Therapy|"Patients were treated with 3-6 cycles of chemotherapy +/- rituximab, with type and duration at the discretion of the individual clinician.~Chemotherapy: 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.~Patients who achieve a partial or complete response after completion of chemotherapy proceed to autologous tumor cell-based vaccine therapy.~Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2.~Treatment continues in the absence of disease progression or unacceptable toxicity."
1247160|NCT00101101|O1|Outcome|Vaccine and Conventional Therapy|"Patients were treated with 3-6 cycles of chemotherapy +/- rituximab, with type and duration at the discretion of the individual clinician.~Chemotherapy: 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.~Patients who achieve a partial or complete response after completion of chemotherapy proceed to autologous tumor cell-based vaccine therapy.~Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2.~Treatment continues in the absence of disease progression or unacceptable toxicity."
1247161|NCT00101101|O1|Outcome|Vaccine and Conventional Therapy|"Patients were treated with 3-6 cycles of chemotherapy +/- rituximab, with type and duration at the discretion of the individual clinician.~Chemotherapy: 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.~Patients who achieve a partial or complete response after completion of chemotherapy proceed to autologous tumor cell-based vaccine therapy.~Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2.~Treatment continues in the absence of disease progression or unacceptable toxicity."
1247194|NCT00100841|E1|Reported Event|Treatment (Combination Chemotherapy)|"Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~bevacizumab: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
1247790|NCT00098345|O1|Outcome|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
1247162|NCT00101101|O1|Outcome|Vaccine and Conventional Therapy|"Patients were treated with 3-6 cycles of chemotherapy +/- rituximab, with type and duration at the discretion of the individual clinician.~Chemotherapy: 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.~Patients who achieve a partial or complete response after completion of chemotherapy proceed to autologous tumor cell-based vaccine therapy.~Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2.~Treatment continues in the absence of disease progression or unacceptable toxicity."
1247163|NCT00101101|E1|Reported Event|Vaccine and Conventional Therapy|"Patients were treated with 3-6 cycles of chemotherapy +/- rituximab, with type and duration at the discretion of the individual clinician.~Chemotherapy: 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.~Patients who achieve a partial or complete response after completion of chemotherapy proceed to autologous tumor cell-based vaccine therapy.~Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2.~Treatment continues in the absence of disease progression or unacceptable toxicity."
1247164|NCT00101036|B3|Baseline|Total|Total of all reporting groups
1247165|NCT00101036|B2|Baseline|Arm 2|GW572016 1500 mg orally daily for 28 days, HCC strata
1247166|NCT00101036|B1|Baseline|Arm 1|GW572016 1500 mg orally daily for 28 days, Biliary strata
1247167|NCT00101036|P2|Participant Flow|Arm 2|GW572016 1500 mg orally daily for 28 days, HCC strata
1247168|NCT00101036|P1|Participant Flow|Arm 1|GW572016 1500 mg orally daily for 28 days, Biliary strata
1247169|NCT00101036|O2|Outcome|Arm 2|GW572016 1500 mg orally daily for 28 days, HCC strata
1247170|NCT00101036|O1|Outcome|Arm 1|GW572016 1500 mg orally daily for 28 days, Biliary strata
1247171|NCT00101036|O2|Outcome|Arm 2|GW572016 1500 mg orally daily for 28 days, HCC strata
1247172|NCT00101036|O1|Outcome|Arm 1|GW572016 1500 mg orally daily for 28 days, Biliary strata
1247173|NCT00101036|O2|Outcome|Arm 2|GW572016 1500 mg orally daily for 28 days, HCC strata
1247174|NCT00101036|O1|Outcome|Arm 1|GW572016 1500 mg orally daily for 28 days, Biliary strata
1247175|NCT00101036|E2|Reported Event|Arm 2|GW572016 1500 mg orally daily for 28 days, HCC strata
1247176|NCT00101036|E1|Reported Event|Arm 1|GW572016 1500 mg orally daily for 28 days, Biliary strata
1247177|NCT00100932|B3|Baseline|Total|Total of all reporting groups
1247178|NCT00100932|B2|Baseline|E7389 21 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
1247179|NCT00100932|B1|Baseline|E7389 28 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
1247180|NCT00100932|P2|Participant Flow|E7389 21 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
1247181|NCT00100932|P1|Participant Flow|E7389 28 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
1247182|NCT00100932|O2|Outcome|E7389 21 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
1247183|NCT00100932|O1|Outcome|E7389 28 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
1247184|NCT00100932|O2|Outcome|E7389 21 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
1247579|NCT00098787|B4|Baseline|Total|Total of all reporting groups
1247186|NCT00100932|O2|Outcome|E7389 21 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
1247187|NCT00100932|O1|Outcome|E7389 28 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
1247188|NCT00100932|E2|Reported Event|E7389 21 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
1247189|NCT00100932|E1|Reported Event|E7389 28 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
1247190|NCT00100841|B1|Baseline|Treatment (Combination Chemotherapy)|"Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~bevacizumab: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
1247191|NCT00100841|P1|Participant Flow|Treatment (Combination Chemotherapy)|"Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~bevacizumab: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
1247192|NCT00100841|O1|Outcome|Treatment (Combination Chemotherapy)|"Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~bevacizumab: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
1247193|NCT00100841|O1|Outcome|Treatment (Combination Chemotherapy)|"Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~bevacizumab: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
1247195|NCT00100815|B1|Baseline|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
1247196|NCT00100815|P1|Participant Flow|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
1247197|NCT00100815|O1|Outcome|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
1247198|NCT00100815|O1|Outcome|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
1247199|NCT00100815|O1|Outcome|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
1247200|NCT00100815|O1|Outcome|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
1247201|NCT00100815|O1|Outcome|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
1247202|NCT00100815|E1|Reported Event|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
1247203|NCT00100802|B1|Baseline|Surgery, Chemoradiotherapy, Rest, Maintenance, FUP|"Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.~lomustine: Capsule~temozolomide: Capsule~adjuvant therapy~radiation therapy"
1247204|NCT00100802|P1|Participant Flow|Surgery, Chemoradiotherapy, Rest, Maintenance, Follow-up|"Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.~lomustine: Capsule~temozolomide: Capsule~adjuvant therapy~radiation therapy"
1247205|NCT00100802|O1|Outcome|Surgery, Chemoradiotherapy, Rest, Maintenance, FUP|"Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.~lomustine: Capsule~temozolomide: Capsule~adjuvant therapy~radiation therapy"
1247237|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
1247238|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
1247206|NCT00100802|O1|Outcome|Surgery, Chemoradiotherapy, Rest, Maintenance, FUP|"Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.~lomustine: Capsule~temozolomide: Capsule~adjuvant therapy~radiation therapy"
1247207|NCT00100802|E1|Reported Event|Surgery, Chemoradiotherapy, Rest, Maintenance, FUP|"Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.~lomustine: Capsule~temozolomide: Capsule~adjuvant therapy~radiation therapy"
1247208|NCT00100789|B1|Baseline|Gemcitabine and Paclitaxel|Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR. Eligible patients who received any treatment were included in baseline measures.
1247209|NCT00100789|P1|Participant Flow|Gemcitabine and Paclitaxel|Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
1247210|NCT00100789|O1|Outcome|Gemcitabine and Paclitaxel|Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
1247211|NCT00100789|O1|Outcome|Gemcitabine and Paclitaxel|Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR. Eligible patients who received any treatment were included in baseline measures.
1247212|NCT00100789|O1|Outcome|Gemcitabine and Paclitaxel|Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
1247213|NCT00100789|O1|Outcome|Gemcitabine and Paclitaxel|Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
1247259|NCT00100659|B2|Baseline|Pegylated Interferon/Placebo|Placebo tablets were supplied in the same dosing regimen as ribavirin, using the same number of tablets that would be given if ribavirin were being administered (eg, 3 placebo tablets twice daily for a 40-kg child who would receive 3 100-mg RV tablets twice daily).
1247214|NCT00100789|E1|Reported Event|Gemcitabine and Paclitaxel|Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
1247215|NCT00100698|B3|Baseline|Total|Total of all reporting groups
1247216|NCT00100698|B2|Baseline|Placebo|placebo subcutaneously once a day
1247217|NCT00100698|B1|Baseline|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
1247218|NCT00100698|P2|Participant Flow|Placebo|placebo subcutaneously once a day
1247219|NCT00100698|P1|Participant Flow|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
1247220|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
1247221|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
1247222|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
1247223|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
1247224|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
1247225|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
1247226|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
1247227|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
1247228|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
1247229|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
1247230|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
1247231|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
1247232|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
1247233|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
1247234|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
1247235|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
1247236|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
1247239|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
1247240|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
1247241|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
1247242|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
1247243|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
1247244|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
1247245|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
1247246|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
1247247|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
1247248|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
1247249|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
1247250|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
1247251|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
1247252|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
1247253|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
1247254|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
1247255|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
1247256|NCT00100698|E2|Reported Event|Placebo|placebo subcutaneously once a day
1247257|NCT00100698|E1|Reported Event|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
1247258|NCT00100659|B3|Baseline|Total|Total of all reporting groups
1247260|NCT00100659|B1|Baseline|Pegylated Interferon/Ribavirin|"Pegasys - 180 mcg per 1.73 meter squared body surface area subcutaneously once weekly.~Ribavirin - 15 mg per kg orally twice daily using 100-mg tablets."
1247261|NCT00100659|P2|Participant Flow|Pegylated Interferon/Placebo|Placebo tablets were supplied in the same dosing regimen as ribavirin, using the same number of tablets that would be given if ribavirin were being administered (eg, 3 placebo tablets twice daily for a 40-kg child who would receive 3 100-mg RV tablets twice daily).
1247262|NCT00100659|P1|Participant Flow|Pegylated Interferon/Ribavirin|"Pegasys - 180 mcg per 1.73 meter squared body surface area subcutaneously once weekly.~Ribavirin - 15 mg per kg orally twice daily using 100-mg tablets."
1247263|NCT00100659|O2|Outcome|PEG/Placebo|Pegylated interferon/placebo
1247264|NCT00100659|O1|Outcome|PEG/RV|Pegylated interferon/ribavirin
1247265|NCT00100659|E2|Reported Event|Pegylated Interferon/Placebo|Placebo tablets were supplied in the same dosing regimen as ribavirin, using the same number of tablets that would be given if ribavirin were being administered (eg, 3 placebo tablets twice daily for a 40-kg child who would receive 3 100-mg RV tablets twice daily).
1247266|NCT00100659|E1|Reported Event|Pegylated Interferon/Ribavirin|"Pegasys - 180 mcg per 1.73 meter squared body surface area subcutaneously once weekly.~Ribavirin - 15 mg per kg orally twice daily using 100-mg tablets."
1247267|NCT00100230|B3|Baseline|Total|Total of all reporting groups
1247268|NCT00100230|B2|Baseline|Corn/Soy Oil Placebo Arm|Corn/soy oil placebo (oils not containing DHA); dosage based on body weight for 4-year trial
1247269|NCT00100230|B1|Baseline|1. Docosahexaenoic Acid (DHA) Arm|Docosahexaenoic acid (an omega-3 polyunsaturated fatty acid) taken orally at a dosage of 30 mg/kg body weight/day for a 4-year duration trial.
1247270|NCT00100230|P2|Participant Flow|Corn/Soy Oil Placebo Arm|Corn/soy oil placebo (oils not containing DHA); dosage based on body weight for 4-year trial
1247271|NCT00100230|P1|Participant Flow|1. Docosahexaenoic Acid (DHA) Arm|Docosahexaenoic acid (an omega-3 polyunsaturated fatty acid) taken orally at a dosage of 30 mg/kg body weight/day for a 4-year duration trial.
1247272|NCT00100230|O2|Outcome|Placebo (Corn/Soy Oil) ARM|"corn/soy oil placebo; oil not containing DHA...dosage based on body weight~docosahexaenoic acid OR corn/soy oil placebo: daily intake of DHA based on body weight or corn/soy oil placebo(oil not containing DHA; 4 year trial"
1247273|NCT00100230|O1|Outcome|DHA (Docosahexaenoic Acid) ARM|"Oral Docosahexaenoic acid, dosage based on body weight~docosahexaenoic acid OR corn/soy oil placebo: daily intake of DHA based on body weight or corn/soy oil placebo(oil not containing DHA; 4 year trial"
1247274|NCT00100230|O2|Outcome|Placebo (Corn/Soy Oil)|"corn/soy oil placebo; oil not containing DHA...dosage based on body weight~docosahexaenoic acid OR corn/soy oil placebo: daily intake of DHA based on body weight or corn/soy oil placebo(oil not containing DHA; 4 year trial"
1247275|NCT00100230|O1|Outcome|DHA (Docosahexaenoic Acid)|"Oral Docosahexaenoic acid, dosage based on body weight~docosahexaenoic acid OR corn/soy oil placebo: daily intake of DHA based on body weight or corn/soy oil placebo(oil not containing DHA; 4 year trial"
1247276|NCT00100230|O2|Outcome|Placebo (Corn/Soy Oil)|"corn/soy oil placebo; oil not containing DHA...dosage based on body weight~docosahexaenoic acid OR corn/soy oil placebo: daily intake of DHA based on body weight or corn/soy oil placebo(oil not containing DHA; 4 year trial"
1247277|NCT00100230|O1|Outcome|DHA (Docosahexaenoic Acid)|"Oral Docosahexaenoic acid, dosage based on body weight~docosahexaenoic acid OR corn/soy oil placebo: daily intake of DHA based on body weight or corn/soy oil placebo(oil not containing DHA; 4 year trial"
1247278|NCT00100230|E2|Reported Event|Corn/Soy Oil Placebo Arm|Corn/soy oil placebo (oils not containing DHA); dosage based on body weight for 4-year trial
1247279|NCT00100230|E1|Reported Event|1. Docosahexaenoic Acid (DHA) Arm|Docosahexaenoic acid (an omega-3 polyunsaturated fatty acid) taken orally at a dosage of 30 mg/kg body weight/day for a 4-year duration trial.
1247280|NCT00100178|B4|Baseline|Total|Total of all reporting groups
1247281|NCT00100178|B3|Baseline|MMF-DZB Placebo Control|Placebo pills given daily for two years AND saline intravenous infusions given at baseline and two weeks later.
1247282|NCT00100178|B2|Baseline|MMF Alone|600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years AND saline intravenous infusions given at baseline and two weeks later
1247283|NCT00100178|B1|Baseline|MMF and DZB|600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years AND DZB given by intravenous infusion (1 mg/kg)at baseline and 2 weeks later.
1247284|NCT00100178|P3|Participant Flow|MMF-DZB Placebo Control|Placebo pills given daily for two years and saline intravenous infusions given at baseline and two weeks later.
1247285|NCT00100178|P2|Participant Flow|MMF Alone|600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years and saline intravenous infusions given at baseline and two weeks later.
1247286|NCT00100178|P1|Participant Flow|MMF and DZB|DZB given by intravenous infusion (1 mg/kg)at baseline and 2 weeks later, and 600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years.
1247287|NCT00100178|O3|Outcome|MMF Alone|600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years and saline intravenous infusions given at baseline and two weeks later.
1247288|NCT00100178|O2|Outcome|Placebo Control|Placebo pills given daily for two years and saline intravenous infusions given at baseline and two weeks later.
1247289|NCT00100178|O1|Outcome|MMF and DZB|DZB given by intravenous infusion (1 mg/kg)at baseline and 2 weeks later, and 600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years.
1247290|NCT00100178|E3|Reported Event|MMF-DZB Placebo Control|Placebo pills given daily for two years AND saline intravenous infusions given at baseline and two weeks later.
1247291|NCT00100178|E2|Reported Event|MMF Alone|600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years and saline intravenous infusions given at baseline and two weeks later.
1247292|NCT00100178|E1|Reported Event|MMF and DZB|600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years and DZB given by intravenous infusion (1 mg/kg)at baseline and 2 weeks later .
1247293|NCT00100048|B6|Baseline|Total|Total of all reporting groups
1247294|NCT00100048|B5|Baseline|Placebo / Efavirenz 600 mg Once Daily (q.d.)|"Cohort I-Monotherapy Phase (10 Days)~Placebo to MK0518 b.i.d.~Cohort II Combined-Combination Therapy Phase (48 Weeks)~Efavirenz + Tenofovir + Lamivudine"
1247295|NCT00100048|B4|Baseline|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase (10 Days)~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 600 mg + tenofovir + lamivudine"
1247296|NCT00100048|B3|Baseline|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase (10 Days)~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 400 mg + tenofovir + lamivudine"
1247297|NCT00100048|B2|Baseline|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase (10 Days)~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 200 mg + tenofovir + lamivudine"
1247298|NCT00100048|B1|Baseline|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase (10 Days)~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 100 mg b.i.d"
1247299|NCT00100048|P6|Participant Flow|Efavirenz 600 mg q.h.s.|"Cohort II Combined-Combination Therapy Phase~efavirenz 600 mg every night at bedtime (q.h.s.)"
1247300|NCT00100048|P5|Participant Flow|Placebo|"Cohort I-Monotherapy Phase~Placebo to MK0518 b.i.d."
1247301|NCT00100048|P4|Participant Flow|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
1247302|NCT00100048|P3|Participant Flow|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
1247303|NCT00100048|P2|Participant Flow|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
1247304|NCT00100048|P1|Participant Flow|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
1247305|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
1247306|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
1247307|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
1247308|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
1247309|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
1247310|NCT00100048|O2|Outcome|EVF Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
1247311|NCT00100048|O1|Outcome|MK-0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
1247312|NCT00100048|O2|Outcome|EVF Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
1247313|NCT00100048|O1|Outcome|MK-0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
1247314|NCT00100048|O2|Outcome|EVF Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
1247315|NCT00100048|O1|Outcome|MK-0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
1247316|NCT00100048|O2|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
1247317|NCT00100048|O1|Outcome|MK0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
1247318|NCT00100048|O2|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
1247319|NCT00100048|O1|Outcome|MK0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
1247320|NCT00100048|O2|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
1247321|NCT00100048|O1|Outcome|MK0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
1247322|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II efavirenz + tenofovir +~lamivudine"
1247323|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
1247324|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
1247325|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
1247326|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
1247327|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II efavirenz + tenofovir +~lamivudine"
1247328|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
1247329|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
1247330|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
1247331|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
1247332|NCT00100048|O2|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
1247333|NCT00100048|O1|Outcome|MK-0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
1247334|NCT00100048|O2|Outcome|EVF Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
1247335|NCT00100048|O1|Outcome|MK-0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
1247336|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II efavirenz + tenofovir +~lamivudine"
1247337|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
1247338|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
1247339|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
1247340|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
1247341|NCT00100048|O2|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
1247342|NCT00100048|O1|Outcome|MK0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
1247343|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
1247344|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
1247345|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
1247346|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
1247347|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
1247348|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
1247349|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
1247350|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
1247351|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
1247352|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
1247353|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
1247354|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
1247355|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
1247356|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
1247357|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
1247358|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
1247359|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
1247360|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
1247361|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
1247362|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
1247363|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
1247364|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
1247365|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
1247366|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
1247367|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
1247368|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
1247369|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
1247370|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
1247371|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
1247372|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
1247373|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
1247374|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
1247375|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
1247376|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
1247377|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
1247378|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
1247379|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
1247380|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
1247381|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
1247382|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
1247383|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
1247384|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
1247385|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
1247386|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
1247387|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
1247388|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
1247389|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
1247390|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
1247391|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
1247392|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
1247393|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II efavirenz + tenofovir +~lamivudine"
1247394|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
1247395|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
1247396|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
1247397|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
1247398|NCT00100048|O5|Outcome|Placebo|"Cohort I-Monotherapy Phase~Placebo to MK0518 b.i.d."
1247399|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d."
1247400|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d."
1247401|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d"
1247402|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)"
1247403|NCT00100048|O5|Outcome|Placebo|"Cohort I-Monotherapy Phase~Placebo to MK0518 b.i.d."
1247404|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d."
1247405|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d."
1247406|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d"
1247407|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)"
1247408|NCT00100048|E2|Reported Event|Efavirenz|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
1247409|NCT00100048|E1|Reported Event|MK-0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
1247410|NCT00099983|B3|Baseline|Total|Total of all reporting groups
1247411|NCT00099983|B2|Baseline|Sugar Pill|"PTSD~Placebo : Placebo"
1247412|NCT00099983|B1|Baseline|Risperidone|Risperidone : atypical antipsychotic
1247413|NCT00099983|P2|Participant Flow|Sugar Pill|Placebo Sugar Pill 1 mg/day HS) for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day. Escalation to a maximum of 4 mg/day will be allowed after a minimum of 4 weeks at the target dose (3 mg/day).
1247414|NCT00099983|P1|Participant Flow|Risperidone|"an atypical antipsychotic indicated for the treatment of schizophrenia but not for Post Traumatic Stress Disorder (PTSD). Some of additional unlabeled uses of risperidone include behavioral symptoms associated with dementia in the elderly, bipolar disorder, Tourette’s disorder, pervasive developmental disorder and autism.~(1 mg/day HS) for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day. Escalation to a maximum of 4 mg/day will be allowed after a minimum of 4 weeks at the target dose (3 mg/day)."
1247415|NCT00099983|O2|Outcome|Sugar Pill|"Placebo 1 mg/day tablet for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day to a maximum of 4 mg/day allowed after a minimum of 4 weeks at the target dose 3 mg/day~Placebo: Placebo"
1247416|NCT00099983|O1|Outcome|Risperidone|"1 mg/day tablet for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day to a maximum of 4 mg/day allowed after a minimum of 4 weeks at the target dose 3 mg/day~Risperidone: Initiate treatment with a low dose (1 mg/day HS) for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day. Escalation to a maximum of 4 mg/day will be allowed after a minimum of 4 weeks at the target dose (3 mg/day). Reduction to a lower dose will be allowed at any time, based on adverse effects. Treatment will continue for 6 months. Patients who discontinue treatment will be allowed to resume treatment at any time."
1247417|NCT00099983|E2|Reported Event|Sugar Pill|"PTSD~Placebo : Placebo"
1247418|NCT00099983|E1|Reported Event|Risperidone|Risperidone : atypical antipsychotic
1247419|NCT00099632|B7|Baseline|Total|Total of all reporting groups
1247420|NCT00099632|B6|Baseline|21-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
1247421|NCT00099632|B5|Baseline|7-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
1247422|NCT00099632|B4|Baseline|21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
1247423|NCT00099632|B3|Baseline|7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
1247424|NCT00099632|B2|Baseline|21-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
1247425|NCT00099632|B1|Baseline|7-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
1247426|NCT00099632|P6|Participant Flow|21-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
1247427|NCT00099632|P5|Participant Flow|7-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
1247428|NCT00099632|P4|Participant Flow|21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
1247429|NCT00099632|P3|Participant Flow|7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
1247430|NCT00099632|P2|Participant Flow|21-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
1247431|NCT00099632|P1|Participant Flow|7-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
1247432|NCT00099632|O6|Outcome|21-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
1247433|NCT00099632|O5|Outcome|7-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
1247434|NCT00099632|O4|Outcome|21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
1247435|NCT00099632|O3|Outcome|7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
1247436|NCT00099632|O2|Outcome|21-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
1247437|NCT00099632|O1|Outcome|7-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
1247438|NCT00099632|O6|Outcome|21-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
1247439|NCT00099632|O5|Outcome|7-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
1247440|NCT00099632|O4|Outcome|21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
1247441|NCT00099632|O3|Outcome|7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
1247442|NCT00099632|O2|Outcome|21-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
1247443|NCT00099632|O1|Outcome|7-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
1247444|NCT00099632|O6|Outcome|21-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
1247445|NCT00099632|O5|Outcome|7-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
1247446|NCT00099632|O4|Outcome|21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
1247447|NCT00099632|O3|Outcome|7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
1247448|NCT00099632|O2|Outcome|21-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
1247449|NCT00099632|O1|Outcome|7-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
1247450|NCT00099632|O6|Outcome|21-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
1247451|NCT00099632|O5|Outcome|7-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
1247452|NCT00099632|O4|Outcome|21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
1247500|NCT00099359|O1|Outcome|Infected|Infants infected after birth
1247453|NCT00099632|O3|Outcome|7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
1247454|NCT00099632|O2|Outcome|21-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
1247455|NCT00099632|O1|Outcome|7-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
1247456|NCT00099632|O6|Outcome|21-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
1247457|NCT00099632|O5|Outcome|7-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
1247458|NCT00099632|O4|Outcome|21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
1247459|NCT00099632|O3|Outcome|7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
1247460|NCT00099632|O2|Outcome|21-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
1247461|NCT00099632|O1|Outcome|7-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
1247462|NCT00099632|E6|Reported Event|21-day LPV/r|SD NVP and LPV/r provided at onset of active labor, followed by 21 days of LPV/r
1247463|NCT00099632|E5|Reported Event|7-day LPV/r|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
1247464|NCT00099632|E4|Reported Event|21-day FTC/TDF|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF
1247465|NCT00099632|E3|Reported Event|7-day FTC/TDF|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF
1247466|NCT00099632|E2|Reported Event|21-day 3TC/ZDV|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV
1247467|NCT00099632|E1|Reported Event|7-day 3TC/ZDV|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV
1247468|NCT00099437|B3|Baseline|Total|Total of all reporting groups
1247469|NCT00099437|B2|Baseline|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
1247470|NCT00099437|B1|Baseline|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
1247471|NCT00099437|P2|Participant Flow|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
1247472|NCT00099437|P1|Participant Flow|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
1247473|NCT00099437|O2|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
1247474|NCT00099437|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
1247475|NCT00099437|O2|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
1247477|NCT00099437|O2|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
1247478|NCT00099437|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
1247479|NCT00099437|O2|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
1247480|NCT00099437|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
1247481|NCT00099437|O2|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
1247482|NCT00099437|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
1247483|NCT00099437|O2|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
1247484|NCT00099437|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
1247485|NCT00099437|O2|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
1247486|NCT00099437|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
1247487|NCT00099437|O2|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
1247488|NCT00099437|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
1247489|NCT00099437|E2|Reported Event|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
1247490|NCT00099437|E1|Reported Event|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
1247491|NCT00099359|B4|Baseline|Total|Total of all reporting groups
1247492|NCT00099359|B3|Baseline|ARM C (ZDV + 3TC + NFV)|"Standard of Care (Zidovudine) plus 2 weeks of Epivir (3TC) and Nelfinavir (NFV) 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND~NFV, given for 2 weeks:~200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 – 3000 grams 100 mg PO BID if BW < 2000 grams"
1247493|NCT00099359|B2|Baseline|ARM B (ZDV + NVP)|"Standard of care (Zidovudine) plus Nevirapine (NVP)~NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :~12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams"
1247494|NCT00099359|B1|Baseline|Arm A (ZDV Only)|Standard of care ( Zidovudine only). 12 mg PO BID if BW>2000 grams ; 8 mg PO BID if BW</= 2000 grams
1247495|NCT00099359|P3|Participant Flow|ARM C (ZDV + 3TC + NFV)|"Standard of Care (Zidovudine) plus 2 weeks of Epivir (3TC) and Nelfinavir (NFV) 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND~NFV, given for 2 weeks:~200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 – 3000 grams 100 mg PO BID if BW < 2000 grams"
1247496|NCT00099359|P2|Participant Flow|ARM B (ZDV + NVP)|"Standard of care (Zidovudine) plus Nevirapine (NVP)~NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :~12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams"
1247497|NCT00099359|P1|Participant Flow|Arm A (ZDV Only)|Standard of care ( Zidovudine only). 12 mg PO BID if BW>2000 grams ; 8 mg PO BID if BW</= 2000 grams
1247498|NCT00099359|O1|Outcome|ARM B (ZDV + NVP)|NVP concentrations were measured in 14 infants immediately before the 3rd dose, 4 hours post dose, 1 day post dose, 3-5 days post dose and 7 days post dose.
1247499|NCT00099359|O2|Outcome|Uninfected|Infants uninfected after birth
1247501|NCT00099359|O1|Outcome|ARM C (ZDV + 3TC/NFV)|Standard ZDV for 6 weeks combined with 2 weeks of 3TC and NFV. NFV and 3TC plasma concentrations were measured by validated HPLC assays with lower detection limit of 0.04 micrograms/mL.
1247502|NCT00099359|O3|Outcome|ARM C (ZDV + 3TC + NFV)|"Standard of Care (Zidovudine) plus 2 weeks of Epivir (3TC) and Nelfinavir (NFV) 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND~NFV, given for 2 weeks:~200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 - 3000 grams 100 mg PO BID if BW < 2000 grams"
1247503|NCT00099359|O2|Outcome|ARM B (ZDV + NVP)|"Standard of care (Zidovudine) plus Nevirapine (NVP)~NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :~12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams"
1247504|NCT00099359|O1|Outcome|Arm A (ZDV Only)|Standard of care ( Zidovudine only). 12 mg PO BID if BW>2000 grams ; 8 mg PO BID if BW</= 2000 grams
1247505|NCT00099359|O3|Outcome|ARM C (ZDV + 3TC + NFV)|"Standard of Care (Zidovudine) plus 2 weeks of Epivir (3TC) and Nelfinavir (NFV) 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND~NFV, given for 2 weeks:~200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 - 3000 grams 100 mg PO BID if BW < 2000 grams"
1247506|NCT00099359|O2|Outcome|ARM B (ZDV + NVP)|"Standard of care (Zidovudine) plus Nevirapine (NVP)~NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :~12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams"
1247507|NCT00099359|O1|Outcome|Arm A (ZDV Only)|Standard of care ( Zidovudine only). 12 mg PO BID if BW>2000 grams ; 8 mg PO BID if BW</= 2000 grams
1247508|NCT00099359|O3|Outcome|ARM C (ZDV + 3TC/NFV)|ZDV + 3TC/NFV
1247509|NCT00099359|O2|Outcome|ARM B (ZDV + NVP)|ZDV + NVP
1247510|NCT00099359|O1|Outcome|ARM A (ZDV Only)|ZDV only
1247511|NCT00099359|O3|Outcome|ARM C (ZDV +3TC+NFV)|"ZDV (standard of care) plus 3TC, given for 2 weeks:~6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND~NFV, given for 2 weeks:~200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 - 3000 grams 100 mg PO BID if BW < 2000 grams"
1247512|NCT00099359|O2|Outcome|ARM B (ZDV + NVP)|plus NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose : 12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams
1247513|NCT00099359|O1|Outcome|ARM A (ZDV - Standard of Care)|"ZDV (standard of care), given for 6 weeks:~12 mg PO BID if birthweight (BW) > 2000 grams 8 mg PO BID if BW < 2000 grams"
1247514|NCT00099359|E3|Reported Event|ARM C (ZDV + 3TC/NFV)|"ZDV, given for 6 weeks:~12 mg PO BID if birthweight (BW) > 2000 grams 8 mg PO BID if BW < 2000 grams AND 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND~NFV, given for 2 weeks:~200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 – 3000 grams 100 mg PO BID if BW < 2000 grams"
1247515|NCT00099359|E2|Reported Event|ARM B (ZDV + NVP)|"ZDV, given for 6 weeks:~12 mg PO BID if birthweight (BW) > 2000 grams 8 mg PO BID if BW < 2000 grams~AND NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :~12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams"
1247516|NCT00099359|E1|Reported Event|ARM A (ZDV Alone)|"ZDV, given for 6 weeks:~12 mg PO BID if birthweight (BW) > 2000 grams 8 mg PO BID if BW < 2000 grams"
1247517|NCT00099268|B3|Baseline|Total|Total of all reporting groups
1247518|NCT00099268|B2|Baseline|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
1247519|NCT00099268|B1|Baseline|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
1247520|NCT00099268|P2|Participant Flow|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
1247521|NCT00099268|P1|Participant Flow|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
1247522|NCT00099268|O2|Outcome|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
1247523|NCT00099268|O1|Outcome|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
1247524|NCT00099268|O2|Outcome|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
1247525|NCT00099268|O1|Outcome|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
1247526|NCT00099268|O2|Outcome|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
1247791|NCT00098345|O1|Outcome|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
1247527|NCT00099268|O1|Outcome|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
1247528|NCT00099268|O2|Outcome|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
1247529|NCT00099268|O1|Outcome|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
1247530|NCT00099268|O2|Outcome|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
1247531|NCT00099268|O1|Outcome|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
1247532|NCT00099268|O2|Outcome|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
1247533|NCT00099268|O1|Outcome|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
1247534|NCT00099268|E2|Reported Event|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
1247535|NCT00099268|E1|Reported Event|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
1247536|NCT00099047|B3|Baseline|Total|Total of all reporting groups
1247537|NCT00099047|B2|Baseline|Arm II (Placebo)|Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
1247538|NCT00099047|B1|Baseline|Arm I (Celecoxib)|Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
1247539|NCT00099047|P2|Participant Flow|Arm II (Placebo)|Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
1247540|NCT00099047|P1|Participant Flow|Arm I (Celecoxib)|Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
1247541|NCT00099047|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
1247542|NCT00099047|O1|Outcome|Arm I (Celecoxib)|Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
1247543|NCT00099047|E2|Reported Event|Arm II (Placebo)|Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
1247544|NCT00099047|E1|Reported Event|Arm I (Celecoxib)|Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
1247545|NCT00099021|B1|Baseline|Pioglitazone Patients|Patients with measurable leukoplakia who received all study medication (oral pioglitazone once daily for 12 weeks) and completed the trial.
1247546|NCT00099021|P1|Participant Flow|Pioglitazone Patients|Patients with measurable leukoplakia who received all study medication (oral pioglitazone once daily for 12 weeks) and completed the trial.
1247547|NCT00099021|O1|Outcome|Pioglitazone Patients|Patients with measurable leukoplakia who received all study medication (oral pioglitazone once daily for 12 weeks) and completed the trial.
1247548|NCT00099021|O1|Outcome|Pioglitazone Patients|Patients with measurable leukoplakia who received all study medication (oral pioglitazone once daily for 12 weeks) and completed the trial.
1247549|NCT00099021|O1|Outcome|Pioglitazone Patients|Patients with measurable leukoplakia who received all study medication (oral pioglitazone once daily for 12 weeks) and completed the trial.
1247550|NCT00099021|E1|Reported Event|Pioglitazone Patients|Patients with measurable leukoplakia who received all study medication (oral pioglitazone once daily for 12 weeks) and completed the trial.
1247551|NCT00098956|B1|Baseline|Treatment (Topotecan Hydrochloride, UCN-01)|"Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR.~topotecan hydrochloride: Given IV~7-hydroxystaurosporine: Given IV"
1247552|NCT00098956|P1|Participant Flow|Treatment (Topotecan Hydrochloride, UCN-01)|"Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR.~topotecan hydrochloride: Given IV~7-hydroxystaurosporine: Given IV"
1247553|NCT00098956|O1|Outcome|Treatment (Topotecan Hydrochloride, UCN-01)|"Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR.~topotecan hydrochloride: Given IV~7-hydroxystaurosporine: Given IV"
1247792|NCT00098345|O1|Outcome|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
1247554|NCT00098956|O1|Outcome|Treatment (Topotecan Hydrochloride, UCN-01)|"Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR.~topotecan hydrochloride: Given IV~7-hydroxystaurosporine: Given IV"
1247555|NCT00098956|E1|Reported Event|Treatment (Topotecan Hydrochloride, UCN-01)|"Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR.~topotecan hydrochloride: Given IV~7-hydroxystaurosporine: Given IV"
1247556|NCT00098865|B1|Baseline|Thalidomide and Temozolomide|"Thalidomide:~Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.~Temozolomide:~Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.~Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression."
1247557|NCT00098865|P1|Participant Flow|Thalidomide and Temozolomide|"Thalidomide:~Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.~Temozolomide:~Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.~Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression"
1247558|NCT00098865|O1|Outcome|Thalidomide and Temozolomide|"Thalidomide:~Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.~Temozolomide:~Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.~Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression~temozolomide: The lower 150/m2 Temozolomide dose was for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal raditation.~thalidomide: Calculated dose was rounded down to the nearest 50mg, or up to 50mg if calculated dose was less than 50mg. Patients increased the daily dose by 50mg (one capsule) on a weekly basis unitl either unacceptable toxicity or a maximum dose."
1247580|NCT00098787|B3|Baseline|Arm C (Low or Intermediate TS, FOLFOX/Bev)|Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
1247581|NCT00098787|B2|Baseline|Arm B (High TS, FOLFOX/Bev)|Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
1247559|NCT00098865|O1|Outcome|Thalidomide and Temozolomide|"Thalidomide:~Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.~Temozolomide:~Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.~Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression~temozolomide: The lower 150/m2 Temozolomide dose was for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal raditation.~thalidomide: Calculated dose was rounded down to the nearest 50mg, or up to 50mg if calculated dose was less than 50mg. Patients increased the daily dose by 50mg (one capsule) on a weekly basis unitl either unacceptable toxicity or a maximum dose."
1247560|NCT00098865|O1|Outcome|Thalidomide and Temozolomide|"Thalidomide:~Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.~Temozolomide:~Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.~Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression~temozolomide: The lower 150/m2 Temozolomide dose was for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal raditation.~thalidomide: Calculated dose was rounded down to the nearest 50mg, or up to 50mg if calculated dose was less than 50mg. Patients increased the daily dose by 50mg (one capsule) on a weekly basis unitl either unacceptable toxicity or a maximum dose."
1247561|NCT00098865|E1|Reported Event|Thalidomide and Temzolomide|"Thalidomide:~Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.~Temozolomide:~Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.~Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression."
1247562|NCT00098839|B3|Baseline|Total|Total of all reporting groups
1247563|NCT00098839|B2|Baseline|Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly|"Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
1247589|NCT00098787|O3|Outcome|Arm C (Low or Intermediate TS, FOLFOX/Bev)|Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
1247564|NCT00098839|B1|Baseline|Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly|"Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
1247565|NCT00098839|P2|Participant Flow|Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly|"Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, high-dose (HD) methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), Intrathecal triple therapy (ITT) (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
1247566|NCT00098839|P1|Participant Flow|Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly|"Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, high-dose (HD) methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), Intrathecal triple therapy (ITT) (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
1247567|NCT00098839|O2|Outcome|Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly|"Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
1248362|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1247568|NCT00098839|O1|Outcome|Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly|"Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
1247569|NCT00098839|O2|Outcome|Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly|"Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
1247570|NCT00098839|O1|Outcome|Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly|"Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
1247590|NCT00098787|O2|Outcome|Arm B (High TS, FOLFOX/Bev)|Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
1247633|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
1247571|NCT00098839|O2|Outcome|Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly|"Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
1247572|NCT00098839|O1|Outcome|Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly|"Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
1247573|NCT00098839|E2|Reported Event|Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly|"Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
1247574|NCT00098839|E1|Reported Event|Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly|"Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
1247575|NCT00098813|B1|Baseline|Treatment (Romidepsin)|Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.
1247576|NCT00098813|P1|Participant Flow|Treatment (Romidepsin)|Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.
1247577|NCT00098813|O1|Outcome|Treatment (Romidepsin)|Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.
1247578|NCT00098813|E1|Reported Event|Treatment (Romidepsin)|Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.
1247582|NCT00098787|B1|Baseline|Arm A (High TS, IROX/Bev)|Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
1247583|NCT00098787|P3|Participant Flow|Arm C (Low or Intermediate TS, FOLFOX/Bev)|Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
1247584|NCT00098787|P2|Participant Flow|Arm B (High TS, FOLFOX/Bev)|Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
1247585|NCT00098787|P1|Participant Flow|Arm A (High TS, IROX/Bev)|Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
1247586|NCT00098787|O3|Outcome|Arm C (Low or Intermediate TS, FOLFOX/Bev)|Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
1247587|NCT00098787|O2|Outcome|Arm B (High TS, FOLFOX/Bev)|Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
1247588|NCT00098787|O1|Outcome|Arm A (High TS, IROX/Bev)|Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
1247591|NCT00098787|O1|Outcome|Arm A (High TS, IROX/Bev)|Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
1247592|NCT00098787|O3|Outcome|Arm C (Low or Intermediate TS, FOLFOX/Bev)|Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
1247593|NCT00098787|O2|Outcome|Arm B (High TS, FOLFOX/Bev)|Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
1247594|NCT00098787|O1|Outcome|Arm A (High TS, IROX/Bev)|Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
1247595|NCT00098787|E3|Reported Event|Low or Indeterminate TS: FOLFOX/Bev|Patients with low or intermediate thymidylate synthase (TS) receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
1247596|NCT00098787|E2|Reported Event|High TS: FOLFOX/Bev|Patients with high thymidylate synthase (TS) who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in arm I, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
1247597|NCT00098787|E1|Reported Event|High TS: IROX/Bev|Patients with high thymidylate synthase (TS) who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol.
1247598|NCT00098774|B1|Baseline|Intensive Combination Chemo & Immunotherapy|"Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11~Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16~Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11~Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)"
1247617|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
1247618|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
1247599|NCT00098774|P1|Participant Flow|Intensive Combination Chemo & Immunotherapy|"Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11~Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16~Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11~Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)"
1247600|NCT00098774|O1|Outcome|Intensive Combination Chemo & Immunotherapy|"Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11~Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16~Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11~Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)"
1247601|NCT00098774|O1|Outcome|Intensive Combination Chemo & Immunotherapy|"Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11~Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16~Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11~Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)"
1247602|NCT00098774|O1|Outcome|Intensive Combination Chemo & Immunotherapy|"Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11~Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16~Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11~Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)"
1247631|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
1247632|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
1247603|NCT00098774|O1|Outcome|Intensive Combination Chemo & Immunotherapy|"Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11~Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16~Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11~Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)"
1247604|NCT00098774|E1|Reported Event|Intensive Combination Chemo & Immunotherapy|"Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11~Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16~Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11~Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)"
1247605|NCT00098748|B4|Baseline|Total|Total of all reporting groups
1247606|NCT00098748|B3|Baseline|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
1247607|NCT00098748|B2|Baseline|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
1247608|NCT00098748|B1|Baseline|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
1247609|NCT00098748|P3|Participant Flow|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
1247610|NCT00098748|P2|Participant Flow|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
1247611|NCT00098748|P1|Participant Flow|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
1247612|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
1247613|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
1247614|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
1247615|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
1247616|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
1247619|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
1247620|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
1247621|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
1247622|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
1247623|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
1247624|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
1247625|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
1247626|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
1247627|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
1247628|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
1247629|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
1247630|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
1247793|NCT00098345|O1|Outcome|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
1247634|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
1247635|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
1247636|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
1247637|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
1247638|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
1247639|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
1247640|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
1247641|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
1247642|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
1247643|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
1247644|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
1247645|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
1247646|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
1247647|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
1247648|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
1247738|NCT00098670|O1|Outcome|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
1247649|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
1247650|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
1247651|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
1247652|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
1247653|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
1247654|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
1247655|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
1247656|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
1247657|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
1247658|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
1247659|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
1247660|NCT00098748|E3|Reported Event|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
1247661|NCT00098748|E2|Reported Event|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
1247683|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247662|NCT00098748|E1|Reported Event|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
1247663|NCT00098722|B4|Baseline|Total|Total of all reporting groups
1247664|NCT00098722|B3|Baseline|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247665|NCT00098722|B2|Baseline|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247666|NCT00098722|B1|Baseline|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247667|NCT00098722|P7|Participant Flow|In Study-off Drug (ISOD), Observation Phase|Participants continuing from open label phase, who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
1247668|NCT00098722|P6|Participant Flow|Maraviroc BID, Observation Phase|Participants continuing from open label phase, who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
1247669|NCT00098722|P5|Participant Flow|In Study-off Drug (ISOD), Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
1247670|NCT00098722|P4|Participant Flow|Maraviroc BID, Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
1247671|NCT00098722|P3|Participant Flow|Placebo, Double Blind|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247672|NCT00098722|P2|Participant Flow|Maraviroc BID, Double Blind|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247673|NCT00098722|P1|Participant Flow|Maraviroc QD, Double Blind|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247674|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247675|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247676|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247677|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247678|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247679|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247680|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247681|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247682|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247684|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247685|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247686|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247687|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247688|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247689|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247690|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247691|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247692|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247693|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247694|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247695|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247696|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247697|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247698|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247699|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247700|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247701|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247702|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247703|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247704|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247705|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247706|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247707|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247708|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247709|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247710|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247711|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247712|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247713|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247714|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247715|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247716|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247717|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247718|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247719|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247720|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247721|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247722|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247723|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247724|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247725|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247726|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247727|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247728|NCT00098722|E7|Reported Event|In Study-off Drug, Observation Phase|Participants continuing from open label phase, who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
1247729|NCT00098722|E6|Reported Event|Maraviroc BID, Observation Phase|Participants continuing from open label phase, who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
1247730|NCT00098722|E5|Reported Event|In Study-off Drug, Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
1247731|NCT00098722|E4|Reported Event|Maraviroc BID, Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
1247732|NCT00098722|E3|Reported Event|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247733|NCT00098722|E2|Reported Event|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247734|NCT00098722|E1|Reported Event|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247735|NCT00098670|B1|Baseline|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
1247736|NCT00098670|P1|Participant Flow|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
1247737|NCT00098670|O1|Outcome|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
1247739|NCT00098670|O1|Outcome|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
1247740|NCT00098670|O1|Outcome|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
1247741|NCT00098670|O1|Outcome|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
1247742|NCT00098670|E2|Reported Event|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction
1247743|NCT00098670|E1|Reported Event|FR Induction|Fludarabine and rituximab induction in pts with B-cell CLL
1247744|NCT00098475|B3|Baseline|Total|Total of all reporting groups
1247745|NCT00098475|B2|Baseline|Arm II (Lenalidomide, Low-dose Dexamethasone)|"Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.~As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only. Toxicity data are available for both the first phase and the expansion phase."
1247746|NCT00098475|B1|Baseline|Arm I (Lenalidomide, Dexamethasone)|"Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.~As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only. Toxicity data are available for both the first phase and the expansion phase."
1247747|NCT00098475|P4|Participant Flow|Arm IV (Expansion; Lenalidomide, Dexamethasone, Coumadin)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment. For patients continuing therapy beyond 4 cycles, coumadin was discontinued and aspirin was given instead.
1247748|NCT00098475|P3|Participant Flow|Arm III (Expansion; Lenalidomide, Dexamethasone, Aspirin)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment or continue until progression.
1247794|NCT00098345|O1|Outcome|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
1247749|NCT00098475|P2|Participant Flow|Arm II (Lenalidomide, Low-dose Dexamethasone)|Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
1247750|NCT00098475|P1|Participant Flow|Arm I (Lenalidomide, Dexamethasone)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
1247751|NCT00098475|O2|Outcome|Arm II (Lenalidomide, Low-dose Dexamethasone)|Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
1247752|NCT00098475|O1|Outcome|Arm I (Lenalidomide, Dexamethasone)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
1247753|NCT00098475|O2|Outcome|Arm II (Lenalidomide, Low-dose Dexamethasone)|Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
1247754|NCT00098475|O1|Outcome|Arm I (Lenalidomide, Dexamethasone)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
1247755|NCT00098475|E6|Reported Event|Arm IV (Expansion; Lenalidomide, Dexamethasone, Coumadin)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment. For patients continuing therapy beyond 4 cycles, coumadin was discontinued and aspirin was given instead.
1247992|NCT00098059|E2|Reported Event|Part B (Multiple-dose of Famciclovir)|Includes 47 patients enrolled in Part B. Part B started only after pharmacokinetic (PK) data from Part A had been analyzed. One patient that participated in Part A of the study also participated in Part B.
1247756|NCT00098475|E5|Reported Event|Arm III (Expansion; Lenalidomide, Dexamethasone, Aspirin)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment or continue until progression.
1247757|NCT00098475|E4|Reported Event|Arm II (Lenalidomide, Low-dose Dexamethasone) Step 2|Arm II patients with minimal response or no response after 4 cycles of treatment in Step 1 could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
1247758|NCT00098475|E3|Reported Event|Arm I (Lenalidomide, Dexamethasone) Step 2|Arm I patients with minimal response or no response after 4 cycles of treatment in Step 1 could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
1247759|NCT00098475|E2|Reported Event|Arm II (Lenalidomide, Low-dose Dexamethasone) Step 1|Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
1247760|NCT00098475|E1|Reported Event|Arm I (Lenalidomide, Dexamethasone) Step 1|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
1247761|NCT00098371|B1|Baseline|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
1247785|NCT00098371|E1|Reported Event|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
1247786|NCT00098345|B1|Baseline|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
1247762|NCT00098371|P1|Participant Flow|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.To improve tolerability of treatment regimen, an amendment to the protocol was done to reduce the cycle length from 42 days to 28 days, reducing the number of treatments per cycle from four (days 1, 8, 15 & 22) to three (days 1, 8, and 15).
1247763|NCT00098371|O2|Outcome|Non-Responders|Patients who had stable disease (SD) or progressive disease (PD)
1247764|NCT00098371|O1|Outcome|Responders|Patients who achieved a partial response (PR)
1247765|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
1247766|NCT00098371|O6|Outcome|Patients Without Complex Karyotype|Complex Karyotype defined as fewer than three cytogenetic aberrations.
1247767|NCT00098371|O5|Outcome|Patients With Complex Karyotype|Complex Karyotype defined as three or more cytogenetic aberrations.
1247768|NCT00098371|O4|Outcome|Patients Without Del(11q22.3)|
1247769|NCT00098371|O3|Outcome|Patients With Del(11q22.3)|
1247770|NCT00098371|O2|Outcome|Patients Without Del(17p13.1)|
1247771|NCT00098371|O1|Outcome|Patients With Del(17p13.1)|
1247772|NCT00098371|O1|Outcome|Treatment (Alvocidib)|"Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.~alvocidib"
1247773|NCT00098371|O2|Outcome|Group 2|Patients with dexamethasone
1247774|NCT00098371|O1|Outcome|Group 1|Patients without dexamethasone
1247775|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
1247776|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
1247777|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
1247778|NCT00098371|O1|Outcome|Treatment (Alvocidib)|"Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.~alvocidib"
1247805|NCT00098306|P2|Participant Flow|Maraviroc BID, Double Blind|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247779|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
1247780|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
1247781|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
1247782|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
1247783|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
1247784|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
1247787|NCT00098345|P1|Participant Flow|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
1247795|NCT00098345|E1|Reported Event|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
1247796|NCT00098306|B4|Baseline|Total|Total of all reporting groups
1247797|NCT00098306|B3|Baseline|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247798|NCT00098306|B2|Baseline|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247799|NCT00098306|B1|Baseline|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247800|NCT00098306|P7|Participant Flow|In Study-off Drug (ISOD), Observation Phase|Participants continuing from open label phase, who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
1247801|NCT00098306|P6|Participant Flow|Maraviroc BID, Observation Phase|Participants continuing from open label phase, who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
1247802|NCT00098306|P5|Participant Flow|In Study-off Drug (ISOD), Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) in during open label phase.
1247803|NCT00098306|P4|Participant Flow|Maraviroc BID, Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
1247804|NCT00098306|P3|Participant Flow|Placebo, Double Blind|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1248034|NCT00097786|O2|Outcome|Non-valsartan|All patients from the treatment arms (1) nateglinide 60 mg ac and (2) placebo.
1247806|NCT00098306|P1|Participant Flow|Maraviroc QD, Double Blind|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247807|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247808|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247809|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247810|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247811|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247812|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247813|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247814|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247815|NCT00098306|O1|Outcome|Maraviroc QD|Description Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247816|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247939|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
1247817|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247818|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247819|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247820|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247821|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247822|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247823|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247824|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247825|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1248035|NCT00097786|O1|Outcome|Valsartan|All patients from the treatment arms (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) valsartan 160 mg od only.
1248363|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1247826|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247827|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247828|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247829|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247830|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247831|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247832|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247833|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247834|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247835|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247888|NCT00098293|O1|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247836|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247837|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247838|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247839|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247840|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247841|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247842|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247843|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247844|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247845|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247846|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247847|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247848|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247849|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247850|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247851|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247852|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247853|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247854|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247855|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247856|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247857|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247858|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247859|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247860|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247861|NCT00098306|E7|Reported Event|In Study-off Drug (ISOD), Observation Phase|Participants continuing from open label phase, who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
1247862|NCT00098306|E6|Reported Event|Maraviroc BID, Observation Phase|Participants continuing from open label phase, who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
1247863|NCT00098306|E5|Reported Event|In Study-off Drug (ISOD), Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) in during open label phase.
1247864|NCT00098306|E4|Reported Event|Maraviroc BID, Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
1247865|NCT00098306|E3|Reported Event|Placebo, Double Blind|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1247866|NCT00098306|E2|Reported Event|Maraviroc BID, Double Blind|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
1248364|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1247867|NCT00098306|E1|Reported Event|Maraviroc QD, Double Blind|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
1247868|NCT00098293|B4|Baseline|Total|Total of all reporting groups
1247869|NCT00098293|B3|Baseline|Efavirenz Once Daily + CBV (DB and OL)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, up to week 96 in DB phase. Efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily from Week 97 up to Week 240 in open-label (OL) phase.
1247870|NCT00098293|B2|Baseline|Maraviroc Twice Daily + CBV (DB and OL)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant’s Week 96 visit. Maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the open-label (OL) phase. OL phase continued for at least 3 years after DB phase.
1247871|NCT00098293|B1|Baseline|Maraviroc Once Daily + CBV (DB)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the double-blind (DB) phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. DB phase nominally ended at last participant’s Week 96 visit.
1247872|NCT00098293|P5|Participant Flow|Maraviroc Twice Daily + CBV (SP)|Participants who remained on mararviroc until their open-label phase End-of-Study visit and for whom maraviroc was commercially or otherwise unavailable entered an additional supplemental phase (SP) (initially planned for 6 months and subsequently extended for another 6 months) which consisted of study visits at 3-month intervals and received maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily until maraviroc was commercially or otherwise available.
1247889|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1248058|NCT00097773|O3|Outcome|Oral Ciprofloxacin|Pooled oral cipro group
1248059|NCT00097773|O2|Outcome|Culture-Based TIS|Pooled Culture-Based TIS therapy group
1247873|NCT00098293|P4|Participant Flow|Maraviroc Twice Daily + CBV (OL)|Participants who received maraviroc 300 mg tablet orally once daily treatment during the DB phase and who were eligible based on safety criteria and virologic response, switched to OL maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, following the DSMB recommendation to terminate the maraviroc once daily treatment arm after planned interim analysis. OL phase continued for at least 3 years after DB phase.
1247874|NCT00098293|P3|Participant Flow|Efavirenz Once Daily + CBV (DB and OL)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant’s Week 96 visit. Efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the OL phase. OL phase continued for at least 3 years after DB phase.
1247875|NCT00098293|P2|Participant Flow|Maraviroc Twice Daily + CBV (DB and OL)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant’s Week 96 visit. Maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the open-label (OL) phase. OL phase continued for at least 3 years after DB phase.
1247876|NCT00098293|P1|Participant Flow|Maraviroc Once Daily + CBV (DB)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the double-blind (DB) phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. DB phase nominally ended at last participant’s Week 96 visit.
1247877|NCT00098293|O2|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247878|NCT00098293|O1|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247879|NCT00098293|O2|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247880|NCT00098293|O1|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247881|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1248213|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
1247882|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247883|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
1247884|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247885|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247886|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
1247887|NCT00098293|O2|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247890|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247891|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
1247892|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247893|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247894|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
1247895|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247896|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247913|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247897|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
1247898|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247899|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247900|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
1247901|NCT00098293|O2|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247902|NCT00098293|O1|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247903|NCT00098293|O2|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247904|NCT00098293|O1|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247905|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247906|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247907|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
1247908|NCT00098293|O2|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247909|NCT00098293|O1|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247910|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247911|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247912|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
1247958|NCT00098059|O2|Outcome|2 to <6 Years|
1247914|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247915|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
1247916|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247917|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247918|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
1247919|NCT00098293|O2|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247920|NCT00098293|O1|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247921|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247922|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
1247923|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
1247924|NCT00098293|E4|Reported Event|Maraviroc Twice Daily + CBV (SP)|Participants who remained on mararviroc until their open-label phase End-of-Study visit and for whom maraviroc was commercially or otherwise unavailable entered an additional supplemental phase (SP) (initially planned for 6 months and subsequently extended for another 6 months) which consisted of study visits at 3-month intervals and received maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily until maraviroc was commercially or otherwise available.
1247925|NCT00098293|E3|Reported Event|Efavirenz Once Daily + CBV (DB and OL)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant’s Week 96 visit. Efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the OL phase. OL phase continued for at least 3 years after DB phase.
1247926|NCT00098293|E2|Reported Event|Maraviroc Twice Daily + CBV (DB and OL)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant’s Week 96 visit. Maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the open-label (OL) phase. OL phase continued for at least 3 years after DB phase.
1247959|NCT00098059|O1|Outcome|1 to < 2 Years|
1247960|NCT00098059|O4|Outcome|13 to <= 18 Years|
1247961|NCT00098059|O3|Outcome|6 to <=12 Years|
1247962|NCT00098059|O2|Outcome|2 to <6 Years|
1247963|NCT00098059|O1|Outcome|1 to < 2 Years|
1247964|NCT00098059|O4|Outcome|13 to <= 18 Years|
1247965|NCT00098059|O3|Outcome|6 to <=12 Years|
1247966|NCT00098059|O2|Outcome|2 to <6 Years|
1247967|NCT00098059|O1|Outcome|1 to < 2 Years|
1247927|NCT00098293|E1|Reported Event|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
1247928|NCT00098254|B1|Baseline|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
1247929|NCT00098254|P1|Participant Flow|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
1247930|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
1247931|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
1247932|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
1247933|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
1247934|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
1247935|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
1247936|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
1247937|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
1247938|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
1247940|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
1247941|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
1247942|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
1247943|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
1247944|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
1247945|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
1247946|NCT00098254|E1|Reported Event|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
1247947|NCT00098059|B3|Baseline|Total|Total of all reporting groups
1247948|NCT00098059|B2|Baseline|Part B (Multiple-dose of Famciclovir)|Each patient in Part B received famciclovir twice a day (b.i.d.) approximately 12 hours apart for 7 days for a total of 14 doses. An 8-step dosing scheme (ranged from 150 mg b.i.d. to 500 mg b.i.d.) was used to determine the weight-based adjusted daily dose.
1247949|NCT00098059|B1|Baseline|Part A (Single-dose of Famciclovir)|Each patient in Part A received a single dose of famciclovir (12.5 mg/kg).
1247950|NCT00098059|P2|Participant Flow|Part B (Multiple-dose of Famciclovir)|Includes 47 patients enrolled in Part B. Part B started only after pharmacokinetic (PK) data from Part A had been analyzed. One patient that participated in Part A of the study also participated in Part B.
1247951|NCT00098059|P1|Participant Flow|Part A (Single-dose of Famciclovir)|Includes 27 patients enrolled in Part A. Two adolescent patients (13 to 18 years) were enrolled in Part A of this study under an amendment to the protocol to include adolescent aged patients. The amendment was rescinded in compliance with an FDA Pediatric Written Request and no further adolescent aged patients were enrolled.
1247952|NCT00098059|O4|Outcome|13 to <=18 Years|
1247953|NCT00098059|O3|Outcome|6 to <13 Years|
1247954|NCT00098059|O2|Outcome|2 to <6 Years|
1247955|NCT00098059|O1|Outcome|1 to < 2 Years|
1247956|NCT00098059|O4|Outcome|13 to <= 18 Years|
1247957|NCT00098059|O3|Outcome|6 to <=12 Years|
1247993|NCT00098059|E1|Reported Event|Part A (Single-dose of Famciclovir)|Includes 27 patients enrolled in Part A. Two adolescent patients (13 to 18 years) were enrolled in Part A of this study under an amendment to the protocol to include adolescent aged patients. The amendment was rescinded in compliance with an FDA Pediatric Written Request and no further adolescent aged patients were enrolled.
1247994|NCT00097981|B3|Baseline|Total|Total of all reporting groups
1247995|NCT00097981|B2|Baseline|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
1247996|NCT00097981|B1|Baseline|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
1247997|NCT00097981|P2|Participant Flow|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
1247998|NCT00097981|P1|Participant Flow|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
1247999|NCT00097981|O2|Outcome|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
1248000|NCT00097981|O1|Outcome|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
1248001|NCT00097981|O2|Outcome|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
1248060|NCT00097773|O1|Outcome|Cycled TIS|Pooled Cycled tobramycin solution for inhalation (TIS) therapy group
1248002|NCT00097981|O1|Outcome|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
1248003|NCT00097981|O2|Outcome|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
1248004|NCT00097981|O1|Outcome|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
1248005|NCT00097981|O2|Outcome|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
1248006|NCT00097981|O1|Outcome|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
1248007|NCT00097981|O2|Outcome|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
1248008|NCT00097981|O1|Outcome|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
1248036|NCT00097786|E4|Reported Event|Placebo|Patients took 3 placebo tablets identical to nateglinide tablets 3 times daily ac and 1 placebo capsule identical to valsartan capsule once daily in the morning.
1248087|NCT00097708|P2|Participant Flow|IR Alprazolam|IR (immediate release) alprazolam (Xanax) administered orally in divided dose (3 times daily), titrated to maximum beneficial dose, 1,2,3,4,5, or 6 mg/day
1248009|NCT00097981|O2|Outcome|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
1248010|NCT00097981|O1|Outcome|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
1248011|NCT00097981|O2|Outcome|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
1248012|NCT00097981|O1|Outcome|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
1248013|NCT00097981|E2|Reported Event|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
1248014|NCT00097981|E1|Reported Event|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
1248015|NCT00097786|B5|Baseline|Total|Total of all reporting groups
1248016|NCT00097786|B4|Baseline|Placebo|Patients took 3 placebo tablets identical to nateglinide tablets 3 times daily ac and 1 placebo capsule identical to valsartan capsule once daily in the morning.
1248017|NCT00097786|B3|Baseline|Nateglinide 60 mg ac + Placebo Valsartan|For the first 2 weeks of treatment, patients took one 30 mg tablet of nateglinide with a glass of water 1-30 minutes before each main meal of the day, ie, 3 times daily ante cibum (ac, before meals). If a meal was missed, the patient was not to take a tablet. After 2 weeks, patients were uptitrated to 60 mg nateglinide ac. Patients also received placebo matching valsartan capsules identical to the active valsartan capsules.
1248061|NCT00097773|E4|Reported Event|Culture-Based TIS w/Cipro|TOBI and oral ciprofloxacin administered only when quarterly respiratory cultures are found positive for PA
1248018|NCT00097786|B2|Baseline|Valsartan 160 mg od + Placebo Nateglinide|For the first 2 weeks of treatment, patients took valsartan 80 mg once daily (od) once in the morning. After 2 weeks, patients were uptitrated to 160 mg valsartan od. Patient also received placebo matching nateglinide tablets identical to the active nateglinide tablets (ac, before meals).
1248019|NCT00097786|B1|Baseline|Valsartan 160 mg od + Nateglinide 60 mg ac|For the first 2 weeks of treatment, patients took the combination of nateglinide 30 mg (3 times daily ante cibum [ac, before meals]) and valsartan 80 mg (once daily [od] in the morning). After 2 weeks, patients were uptitrated to nateglinide 60 mg ac and valsartan 160 mg od.
1248020|NCT00097786|P4|Participant Flow|Placebo|Patients took 3 placebo tablets identical to nateglinide tablets 3 times daily ac and 1 placebo capsule identical to valsartan capsule once daily in the morning.
1248021|NCT00097786|P3|Participant Flow|Nateglinide 60 mg ac + Placebo Valsartan|For the first 2 weeks of treatment, patients took one 30 mg tablet of nateglinide with a glass of water 1-30 minutes before each main meal of the day, ie, 3 times daily ante cibum (ac, before meals). If a meal was missed, the patient was not to take a tablet. After 2 weeks, patients were uptitrated to 60 mg nateglinide ac. Patients also received placebo matching valsartan capsules identical to the active valsartan capsules.
1248022|NCT00097786|P2|Participant Flow|Valsartan 160 mg od + Placebo Nateglinide|For the first 2 weeks of treatment, patients took valsartan 80 mg once daily (od) once in the morning. After 2 weeks, patients were uptitrated to 160 mg valsartan od. Patient also received placebo matching nateglinide tablets identical to the active nateglinide tablets (ac, before meals).
1248023|NCT00097786|P1|Participant Flow|Valsartan 160 mg od + Nateglinide 60 mg ac|For the first 2 weeks of treatment, patients took the combination of nateglinide 30 mg (3 times daily ante cibum [ac, before meals]) and valsartan 80 mg (once daily [od] in the morning). After 2 weeks, patients were uptitrated to nateglinide 60 mg ac and valsartan 160 mg od.
1248024|NCT00097786|O2|Outcome|Non-nateglinide|All patients from the treatment arms (1) valsartan 160 mg od and (2) placebo.
1248025|NCT00097786|O1|Outcome|Nateglinide|All patients from the treatment arm (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) nateglinide 60 mg ac only.
1248026|NCT00097786|O2|Outcome|Non-nateglinide|All patients from the treatment arms (1) valsartan 160 mg od and (2) placebo.
1248027|NCT00097786|O1|Outcome|Nateglinide|All patients from the treatment arm (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) nateglinide 60 mg ac only.
1248028|NCT00097786|O2|Outcome|Non-nateglinide|All patients from the treatment arms (1) valsartan 160 mg od and (2) placebo.
1248029|NCT00097786|O1|Outcome|Nateglinide|All patients from the treatment arm (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) nateglinide 60 mg ac only.
1248030|NCT00097786|O2|Outcome|Non-valsartan|All patients from the treatment arms (1) nateglinide 60 mg ac and (2) placebo.
1248031|NCT00097786|O1|Outcome|Valsartan|All patients from the treatment arms (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) valsartan 160 mg od only.
1248032|NCT00097786|O2|Outcome|Non-valsartan|All patients from the treatment arms (1) nateglinide 60 mg ac and (2) placebo.
1248033|NCT00097786|O1|Outcome|Valsartan|All patients from the treatment arms (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) valsartan 160 mg od only.
1248037|NCT00097786|E3|Reported Event|Nateglinide 60 mg ac + Placebo Valsartan|For the first 2 weeks of treatment, patients took one 30 mg tablet of nateglinide with a glass of water 1-30 minutes before each main meal of the day, ie, 3 times daily ante cibum (ac, before meals). If a meal was missed, the patient was not to take a tablet. After 2 weeks, patients were uptitrated to 60 mg nateglinide ac. Patients also received placebo matching valsartan capsules identical to the active valsartan capsules.
1248038|NCT00097786|E2|Reported Event|Valsartan 160 mg od + Placebo Nateglinide|For the first 2 weeks of treatment, patients took valsartan 80 mg once daily (od) once in the morning. After 2 weeks, patients were uptitrated to 160 mg valsartan od. Patient also received placebo matching nateglinide tablets identical to the active nateglinide tablets (ac, before meals).
1248039|NCT00097786|E1|Reported Event|Valsartan 160 mg od + Nateglinide 60 mg ac|For the first 2 weeks of treatment, patients took the combination of nateglinide 30 mg (3 times daily ante cibum [ac, before meals]) and valsartan 80 mg (once daily [od] in the morning). After 2 weeks, patients were uptitrated to nateglinide 60 mg ac and valsartan 160 mg od.
1248040|NCT00097773|B5|Baseline|Total|Total of all reporting groups
1248041|NCT00097773|B4|Baseline|Culture-Based TIS w/Cipro|TOBI and oral ciprofloxacin administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa)
1248042|NCT00097773|B3|Baseline|Culture-Based TIS w/Placebo|TOBI and oral placebo administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa)
1248043|NCT00097773|B2|Baseline|Cycled TIS w/Cipro|TOBI and oral ciprofloxacin for six consecutive quarterly cycles
1248044|NCT00097773|B1|Baseline|Cycled TIS w/Placebo|TOBI and oral placebo for six consecutive quarterly cycles
1248045|NCT00097773|P4|Participant Flow|Culture-Based TOBI and Oral Placebo|Tobramycin solution for inhalation (TOBI) and oral placebo administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa)
1248046|NCT00097773|P3|Participant Flow|Culture-Based TOBI and Oral Ciprofloxacin|Tobramycin solution for inhalation (TOBI) and oral ciprofloxacin administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa)
1248047|NCT00097773|P2|Participant Flow|Cycled TOBI and Oral Ciprofloxacin|Tobramycin solution for inhalation (TOBI) and oral ciprofloxacin for six consecutive quarterly cycles
1248048|NCT00097773|P1|Participant Flow|Cycled TOBI and Oral Placebo|Tobramycin solution for inhalation (TOBI) and oral placebo for six consecutive quarterly cycles
1248049|NCT00097773|O4|Outcome|Oral Placebo|Pooled oral placebo group
1248050|NCT00097773|O3|Outcome|Oral Ciprofloxacin|Pooled oral cipro group
1248051|NCT00097773|O2|Outcome|Culture-Based TIS|Pooled Culture-Based TIS therapy group
1248052|NCT00097773|O1|Outcome|Cycled TIS|Pooled Cycled TIS therapy group
1248053|NCT00097773|O4|Outcome|Oral Placebo|pooled oral placebo group
1248054|NCT00097773|O3|Outcome|Oral Cipro|Pooled oral cipro group
1248055|NCT00097773|O2|Outcome|Culture-Based TIS|Pooled Culture-Based TIS group
1248056|NCT00097773|O1|Outcome|Cycled TIS|Pooled Cycled TIS group
1248057|NCT00097773|O4|Outcome|Oral Placebo|Pooled oral placebo group
1248062|NCT00097773|E3|Reported Event|Culture-Based TIS w/Placebo|TOBI and oral placebo administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (PA)
1248063|NCT00097773|E2|Reported Event|Cycled TIS w/Cipro|TOBI and oral ciprofloxacin for six consecutive quarterly cycles
1248064|NCT00097773|E1|Reported Event|Cycled TIS w/Placebo|TOBI and oral placebo for six consecutive quarterly cycles
1248065|NCT00097721|B3|Baseline|Total|Total of all reporting groups
1248066|NCT00097721|B2|Baseline|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
1248067|NCT00097721|B1|Baseline|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
1248068|NCT00097721|P2|Participant Flow|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
1248069|NCT00097721|P1|Participant Flow|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
1248070|NCT00097721|O2|Outcome|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
1248071|NCT00097721|O1|Outcome|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
1248072|NCT00097721|O2|Outcome|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
1248073|NCT00097721|O1|Outcome|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
1248074|NCT00097721|O2|Outcome|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
1248075|NCT00097721|O1|Outcome|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
1248076|NCT00097721|O2|Outcome|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
1248077|NCT00097721|O1|Outcome|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
1248078|NCT00097721|O2|Outcome|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
1248079|NCT00097721|O1|Outcome|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
1248080|NCT00097721|E2|Reported Event|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
1248081|NCT00097721|E1|Reported Event|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
1248082|NCT00097708|B4|Baseline|Total|Total of all reporting groups
1248083|NCT00097708|B3|Baseline|Placebo|
1248084|NCT00097708|B2|Baseline|IR Alprazolam|
1248085|NCT00097708|B1|Baseline|OROS Alprazolam|
1248086|NCT00097708|P3|Participant Flow|Placebo|OROS (osmotic [controlled] release oral [delivery] system) placebo administered orally once a day.
1248088|NCT00097708|P1|Participant Flow|OROS Alprazolam|OROS (osmotic [controlled] release oral [delivery] system) alprazolam administered orally once a day, titrated to maximum beneficial dose, 1,2,3,4,5, or 6 mg/day
1248089|NCT00097708|O3|Outcome|Placebo|
1248090|NCT00097708|O2|Outcome|IR Alprazolam|
1248091|NCT00097708|O1|Outcome|OROS Alprazolam|
1248092|NCT00097708|E3|Reported Event|Placebo|
1248093|NCT00097708|E2|Reported Event|IR Alprazolam|
1248094|NCT00097708|E1|Reported Event|OROS Alprazolam|
1248095|NCT00097695|B5|Baseline|Total|Total of all reporting groups
1248096|NCT00097695|B4|Baseline|Untreated Patients at the Baseline|Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing.
1248097|NCT00097695|B3|Baseline|Controlled Open-label / Laryngeal Attack|patients who received first treatment Open-Label due to laryngeal symptoms
1248098|NCT00097695|B2|Baseline|Randomized -Placebo|Patients who were randomized to placebo in the controlled phase after they had an eligible first in-study attack.
1248099|NCT00097695|B1|Baseline|Randomized -Icatibant|Patients who were randomized to icatibant in the controlled phase after they had an eligible first in-study attack.
1248100|NCT00097695|P4|Participant Flow|Untreated Patients at the Baseline|Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing.
1248101|NCT00097695|P3|Participant Flow|Controlled Open-label / Laryngeal Attack|Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase.
1248102|NCT00097695|P2|Participant Flow|Randomized -Placebo|Patients who were randomized to placebo in the controlled phase after they had an eligible first in-study attack.
1248103|NCT00097695|P1|Participant Flow|Randomized -Icatibant|Patients who were randomized to icatibant in the controlled phase after they had an eligible first in-study attack.
1248104|NCT00097695|O2|Outcome|Randomized Control Trial-placebo|29 Patients were randomized to placebo in the controlled phase after they had an eligible first in-study attack.
1248105|NCT00097695|O1|Outcome|Randomized Control Trial-icatibant|27 Patients were randomized to icatibant in the controlled phase after they had an eligible first in-study attack.
1248106|NCT00097695|O2|Outcome|Randomized -Placebo|29 Patients were randomized to placebo in the controlled phase after they had an eligible first in-study attack.
1248107|NCT00097695|O1|Outcome|Randomized -Icatibant|27 Patients were randomized to icatibant in the controlled phase after they had an eligible first in-study attack.
1248108|NCT00097695|O2|Outcome|Randomized -Placebo|29 Patients were randomized to placebo in the controlled phase after they had an eligible first in-study attack.
1248109|NCT00097695|O1|Outcome|Randomized -Icatibant|27 Patients were randomized to icatibant in the controlled phase after they had an eligible first in-study attack.
1248110|NCT00097695|E6|Reported Event|Open Label Extension Phase(Untreated Patients at the Baseline)|This represents adverse events experienced by Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing.
1248111|NCT00097695|E5|Reported Event|Open Label Extension -Icatibant (Subjects w/ Laryngeal Attack)|This represents adverse events during the open label extension phase that were experienced by Patients with laryngeal symptoms at the baseline and got treated with open label icatibant during the controlled phase.
1248112|NCT00097695|E4|Reported Event|Open Label Extension Phase- Icatibant (Previously Randomized)|Patients who were randomized to either icatibant or placebo in the controlled phase and experienced adverse events while participating in the open label extension phase.
1248113|NCT00097695|E3|Reported Event|Controlled Phase- Icatibant (Subjects w/ Laryngeal Attack)|This represents adverse events during the controlled phase that were experienced by Patients with laryngeal symptoms at the baseline and were treated with open label icatibant during the controlled phase.
1248114|NCT00097695|E2|Reported Event|Controlled Phase- Placebo (Randomized Subjects|Patients who were randomized to placebo in the controlled phase and experienced adverse events while participating in the controlled phase.
1248115|NCT00097695|E1|Reported Event|Controlled Phase- Icatibant (Randomized Subjects )|Patients who were randomized to icatibant in the controlled and experienced adverse events while participating in the controlled phase.
1248116|NCT00097591|B3|Baseline|Total|Total of all reporting groups
1248117|NCT00097591|B2|Baseline|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
1248118|NCT00097591|B1|Baseline|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
1248119|NCT00097591|P2|Participant Flow|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
1248120|NCT00097591|P1|Participant Flow|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
1248121|NCT00097591|O2|Outcome|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
1248122|NCT00097591|O1|Outcome|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
1248123|NCT00097591|O2|Outcome|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
1248299|NCT00096785|P1|Participant Flow|Entecavir|ETV 0.5 mg once daily (QD)
1248300|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
1248124|NCT00097591|O1|Outcome|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
1248125|NCT00097591|O2|Outcome|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
1248126|NCT00097591|O1|Outcome|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
1248127|NCT00097591|O2|Outcome|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
1248128|NCT00097591|O1|Outcome|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
1248129|NCT00097591|O2|Outcome|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
1248130|NCT00097591|O1|Outcome|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
1248131|NCT00097591|O2|Outcome|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
1248132|NCT00097591|O1|Outcome|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
1248133|NCT00097591|E2|Reported Event|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
1248134|NCT00097591|E1|Reported Event|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
1248135|NCT00097539|B8|Baseline|Total|Total of all reporting groups
1248136|NCT00097539|B7|Baseline|Undefined Etiology|A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
1248137|NCT00097539|B6|Baseline|Other Etiology|The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
1248138|NCT00097539|B5|Baseline|Renal Disease|Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
1248139|NCT00097539|B4|Baseline|Turner Syndrome|Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
1248140|NCT00097539|B3|Baseline|Idiopathic Short Stature (ISS)|Participants must have had a stimulation result of >/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
1248141|NCT00097539|B2|Baseline|Organic GHD|Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
1248142|NCT00097539|B1|Baseline|Idiopathic Growth Hormone Deficiency (IGHD)|Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.
1248143|NCT00097539|P7|Participant Flow|Undefined Etiology|Participants who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
1248144|NCT00097539|P6|Participant Flow|Other Etiology|Participants who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. The other etiology group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
1248145|NCT00097539|P5|Participant Flow|Renal Disease|Participants who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. Renal etiology group included participants with chronic renal insufficiency (CRI) or End Stage Renal Disease (ESRD) prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
1248301|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
1248146|NCT00097539|P4|Participant Flow|Turner Syndrome|Participants with Turner Syndrome who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
1248147|NCT00097539|P3|Participant Flow|Idiopathic Short Stature (ISS)|Participants with ISS who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. Participants must have had a stimulation result of greater than or equal to (>/=) 10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
1248148|NCT00097539|P2|Participant Flow|Organic Growth Hormone Deficiency (GHD)|Participants who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. Organic GHD etiology group included participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, central nervous system (CNS) tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
1248149|NCT00097539|P1|Participant Flow|Idiopathic Growth Hormone Deficiency (IGHD)|Participants with IGDH who initiated therapy with Growth Hormone (GH) products (somatrem for injection [Protropin], somatropin for injection [Nutropin, Nutropin AQ, and Nutropin Depot]) and who consented to participate in the National Cooperative Growth Study (NCGS) were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. IGDH etiology group included participants with: Documented IGHD (a maximum GH stimulation test result of less than 10 nanograms per milliliter [ng/mL], coupled with a specific diagnosis of IGHD or equivalent condition by the attending physician; Undocumented IGHD (a stimulation test results were not available, but had a physician diagnosis specifically stated as IGHD or equivalent condition in text); or Presumed IGHD (a stimulation result of less than 10 ng/mL, coupled with the absence of any identifiable criterion for assignation to another etiology grouping).
1248150|NCT00097539|O7|Outcome|Undefined Etiology|A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
1248151|NCT00097539|O6|Outcome|Other Etiology|The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
1248152|NCT00097539|O5|Outcome|Renal Disease|Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
1248153|NCT00097539|O4|Outcome|Turner Syndrome|Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
1248154|NCT00097539|O3|Outcome|Idiopathic Short Stature (ISS)|Participants must have had a stimulation result of >/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
1248155|NCT00097539|O2|Outcome|Organic GHD|Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
1248156|NCT00097539|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD)|Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.
1248157|NCT00097539|O7|Outcome|Undefined Etiology|A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
1248158|NCT00097539|O6|Outcome|Other Etiology|The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
1248159|NCT00097539|O5|Outcome|Renal Disease|Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
1248160|NCT00097539|O4|Outcome|Turner Syndrome|Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
1248161|NCT00097539|O3|Outcome|Idiopathic Short Stature (ISS)|Participants must have had a stimulation result of >/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
1248212|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
1248162|NCT00097539|O2|Outcome|Organic GHD|Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
1248163|NCT00097539|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD)|Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.
1248164|NCT00097539|O7|Outcome|Undefined Etiology|A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
1248165|NCT00097539|O6|Outcome|Other Etiology|The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
1248166|NCT00097539|O5|Outcome|Renal Disease|Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
1248167|NCT00097539|O4|Outcome|Turner Syndrome|Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
1248168|NCT00097539|O3|Outcome|Idiopathic Short Stature (ISS)|Participants must have had a stimulation result of >/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
1248169|NCT00097539|O2|Outcome|Organic GHD|Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
1248170|NCT00097539|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD)|Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.
1248171|NCT00097539|O7|Outcome|Undefined Etiology|A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
1248172|NCT00097539|O6|Outcome|Other Etiology|The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
1248173|NCT00097539|O5|Outcome|Renal Disease|Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
1250417|NCT00092677|B1|Baseline|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
1248174|NCT00097539|O4|Outcome|Turner Syndrome|Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
1248175|NCT00097539|O3|Outcome|Idiopathic Short Stature (ISS)|Participants must have had a stimulation result of >/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
1248176|NCT00097539|O2|Outcome|Organic GHD|Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
1248177|NCT00097539|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD)|Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.
1248178|NCT00097539|O7|Outcome|Undefined Etiology|A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
1248179|NCT00097539|O6|Outcome|Other Etiology|The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
1248180|NCT00097539|O5|Outcome|Renal Disease|Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
1248181|NCT00097539|O4|Outcome|Turner Syndrome|Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
1248182|NCT00097539|O3|Outcome|Idiopathic Short Stature (ISS)|Participants must have had a stimulation result of >/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
1248302|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
1248303|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
1248183|NCT00097539|O2|Outcome|Organic GHD|Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
1248184|NCT00097539|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD)|Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.
1248185|NCT00097539|E7|Reported Event|Undefined Etiology|A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
1248186|NCT00097539|E6|Reported Event|Other Etiology|The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
1248187|NCT00097539|E5|Reported Event|Renal Disease|Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
1248188|NCT00097539|E4|Reported Event|Turner Syndrome|Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
1248189|NCT00097539|E3|Reported Event|Idiopathic Short Stature (ISS)|Participants must have had a stimulation result of >/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
1248190|NCT00097539|E2|Reported Event|Organic GHD|Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
1248191|NCT00097539|E1|Reported Event|Idiopathic Growth Hormone Deficiency (IGHD)|Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.
1248192|NCT00097500|B3|Baseline|Total|Total of all reporting groups
1248193|NCT00097500|B2|Baseline|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
1248194|NCT00097500|B1|Baseline|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
1248195|NCT00097500|P2|Participant Flow|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
1248196|NCT00097500|P1|Participant Flow|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
1248197|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
1248198|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
1248199|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
1248200|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
1248201|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
1248202|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
1248203|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
1248204|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
1248205|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
1248206|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
1248207|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
1248208|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
1248209|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
1248210|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
1248211|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
1248214|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
1248215|NCT00097500|E2|Reported Event|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
1248216|NCT00097500|E1|Reported Event|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
1248217|NCT00097448|B3|Baseline|Total|Total of all reporting groups
1248218|NCT00097448|B2|Baseline|Intratympanic Steroids|1ml of methylprednisolone 10mg/ml. 4 doses over 14 days.
1248219|NCT00097448|B1|Baseline|Oral Steroids|Prednisone 60mg per day x 14 days, 5 day taper.
1248220|NCT00097448|P2|Participant Flow|Intratympanic Steroids|1ml of methylprednisolone 10mg/ml. 4 doses over 14 days.
1248221|NCT00097448|P1|Participant Flow|Oral Steroids|Prednisone 60mg per day x 14 days, 5 day taper.
1248222|NCT00097448|O2|Outcome|IT Steroids|methylprednisolone
1248223|NCT00097448|O1|Outcome|Oral Steroids|Prednisone
1248224|NCT00097448|E2|Reported Event|IT Steroids|methylprednisolone
1248225|NCT00097448|E1|Reported Event|Oral Steroids|Prednisone
1248226|NCT00097370|B1|Baseline|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
1248227|NCT00097370|P1|Participant Flow|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by intravenous (IV) infusion monthly in Stage 1 along with concomitant hypereosinophilic syndrome (HES)-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
1248228|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
1248229|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
1248245|NCT00097253|O3|Outcome|Lemon|A yellow-tinted cotton ball containing 100 μL of the essential oil or water control was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
1248338|NCT00095498|B2|Baseline|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248230|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
1248231|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
1248232|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
1248233|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
1248234|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
1248235|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
1248236|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
1248304|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
1248305|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
1248306|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
1248307|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
1248308|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
1248237|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
1248238|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
1248239|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
1248240|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
1248241|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
1248242|NCT00097370|E1|Reported Event|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
1248243|NCT00097253|B1|Baseline|Lavender Oil / Lemon Oil / Water Control|A yellow-tinted cotton ball containing 100 μL of the essential oil or water placebo was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
1248244|NCT00097253|P1|Participant Flow|Lavender Oil / Lemon Oil / Water Control|A yellow-tinted cotton ball containing 100 μL of the essential oil or water placebo was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
1250418|NCT00092677|P2|Participant Flow|Placebo|
1248246|NCT00097253|O2|Outcome|Water Control|A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
1248247|NCT00097253|O1|Outcome|Lavender|A yellow-tinted cotton ball containing 100 μL of the essential oil or water control was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
1248248|NCT00097253|O3|Outcome|Lemon|A yellow-tinted cotton ball containing 100 μL of the essential oil or water control was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
1248249|NCT00097253|O2|Outcome|Water Control|A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
1248250|NCT00097253|O1|Outcome|Lavender|A yellow-tinted cotton ball containing 100 μL of the essential oil or water control was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
1248251|NCT00097253|O3|Outcome|Lemon|A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
1248252|NCT00097253|O2|Outcome|Water Control|A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
1248253|NCT00097253|O1|Outcome|Lavender|A yellow-tinted cotton ball containing 100 μL of the essential oil or water placebo was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
1248254|NCT00097253|O3|Outcome|Lemon|A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
1248255|NCT00097253|O2|Outcome|Water Control|A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
1248256|NCT00097253|O1|Outcome|Lavender|A yellow-tinted cotton ball containing 100 μL of the essential oil or water placebo was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
1248257|NCT00097253|E1|Reported Event|Lavender Oil / Lemon Oil / Water Control|A yellow-tinted cotton ball containing 100 μL of the essential oil or water placebo was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
1248258|NCT00096993|B3|Baseline|Total|Total of all reporting groups
1248309|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
1248310|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
1248259|NCT00096993|B2|Baseline|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles~Gemcitabine: Gemcitabine was provided as a solution for infusion.~Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
1248260|NCT00096993|B1|Baseline|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).~Placebo: Placebo was provided as a single-use formulation for infusion.~Gemcitabine: Gemcitabine was provided as a solution for infusion."
1248261|NCT00096993|P2|Participant Flow|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles~Gemcitabine: Gemcitabine was provided as a solution for infusion.~Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
1248262|NCT00096993|P1|Participant Flow|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).~Placebo: Placebo was provided as a single-use formulation for infusion.~Gemcitabine: Gemcitabine was provided as a solution for infusion."
1248263|NCT00096993|O2|Outcome|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles~Gemcitabine: Gemcitabine was provided as a solution for infusion.~Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
1248264|NCT00096993|O1|Outcome|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).~Placebo: Placebo was provided as a single-use formulation for infusion.~Gemcitabine: Gemcitabine was provided as a solution for infusion."
1248265|NCT00096993|O2|Outcome|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles~Gemcitabine: Gemcitabine was provided as a solution for infusion.~Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
1248284|NCT00096954|O2|Outcome|Placebo|The dose of placebo was administered by subcutaneous injection every 2 or 4 weeks.
1248266|NCT00096993|O1|Outcome|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).~Placebo: Placebo was provided as a single-use formulation for infusion.~Gemcitabine: Gemcitabine was provided as a solution for infusion."
1248267|NCT00096993|O2|Outcome|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles~Gemcitabine: Gemcitabine was provided as a solution for infusion.~Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
1248268|NCT00096993|O1|Outcome|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).~Placebo: Placebo was provided as a single-use formulation for infusion.~Gemcitabine: Gemcitabine was provided as a solution for infusion."
1248269|NCT00096993|O2|Outcome|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles~Gemcitabine: Gemcitabine was provided as a solution for infusion.~Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
1248270|NCT00096993|O1|Outcome|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).~Placebo: Placebo was provided as a single-use formulation for infusion.~Gemcitabine: Gemcitabine was provided as a solution for infusion."
1248271|NCT00096993|O2|Outcome|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles~Gemcitabine: Gemcitabine was provided as a solution for infusion.~Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
1248272|NCT00096993|O1|Outcome|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).~Placebo: Placebo was provided as a single-use formulation for infusion.~Gemcitabine: Gemcitabine was provided as a solution for infusion."
1248311|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
1248312|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
1248273|NCT00096993|E2|Reported Event|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles~Gemcitabine: Gemcitabine was provided as a solution for infusion.~Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
1248274|NCT00096993|E1|Reported Event|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).~Placebo: Placebo was provided as a single-use formulation for infusion.~Gemcitabine: Gemcitabine was provided as a solution for infusion."
1248275|NCT00096954|B3|Baseline|Total|Total of all reporting groups
1248276|NCT00096954|B2|Baseline|Placebo|The dose of placebo was administered by subcutaneous injection every 2 or 4 weeks.
1248277|NCT00096954|B1|Baseline|Omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
1248278|NCT00096954|P2|Participant Flow|Placebo|The dose of placebo consisting of sucrose, L-histidine, L-histidine hydrochloride monohydrate, and polysorbate 20 was administered by subcutaneous injection every 2 or 4 weeks.
1248279|NCT00096954|P1|Participant Flow|Omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
1248280|NCT00096954|O2|Outcome|Placebo|The dose of placebo was administered by subcutaneous injection every 2 or 4 weeks.
1248281|NCT00096954|O1|Outcome|Omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
1248282|NCT00096954|O2|Outcome|Placebo|The dose of placebo was administered by subcutaneous injection every 2 or 4 weeks.
1248283|NCT00096954|O1|Outcome|Omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
1248285|NCT00096954|O1|Outcome|Omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
1248286|NCT00096954|O2|Outcome|Placebo|The dose of placebo was administered by subcutaneous injection every 2 or 4 weeks.
1248287|NCT00096954|O1|Outcome|Omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
1248288|NCT00096954|E2|Reported Event|Placebo|The dose of placebo was administered by subcutaneous injection every 2 or 4 weeks.
1248289|NCT00096954|E1|Reported Event|Omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
1248290|NCT00096941|B1|Baseline|Pertuzumab|"Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression.~Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation."
1248291|NCT00096941|P1|Participant Flow|Pertuzumab|"Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression.~Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation."
1248292|NCT00096941|O1|Outcome|Pertuzumab|"Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression.~Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation."
1248293|NCT00096941|O1|Outcome|Pertuzumab|"Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression.~Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation."
1248294|NCT00096941|E1|Reported Event|Pertuzumab|"Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression.~Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation."
1248295|NCT00096785|B3|Baseline|Total|Total of all reporting groups
1248296|NCT00096785|B2|Baseline|Adefovir|ADV 10 mg QD
1248297|NCT00096785|B1|Baseline|Entecavir|ETV 0.5 mg once daily (QD)
1248298|NCT00096785|P2|Participant Flow|Adefovir|ADV 10 mg QD
1248322|NCT00096681|B1|Baseline|Participants From the Community|The number of participants from the community who attended the clinic for a once off study visit
1248323|NCT00096681|P1|Participant Flow|Participants From the Community|The number of participants from the community who attended the clinic for a once off study visit
1248324|NCT00096681|O1|Outcome|Participants From the Community|The number of participants from the community who attended the clinic for a once off study visit
1248325|NCT00096681|O1|Outcome|Participants From the Community|The number of participants from the community who attended the clinic for a once off study visit
1248326|NCT00096681|E1|Reported Event|Participants From the Community|The number of participants from the community who attended the clinic for a once off study visit
1248327|NCT00095563|B1|Baseline|Treatment (Lapatinib Ditosylate)|"Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~lapatinib ditosylate: Given orally~laboratory biomarker analysis: Correlative studies"
1248328|NCT00095563|P1|Participant Flow|Treatment (Lapatinib Ditosylate)|"Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~lapatinib ditosylate: Given orally~laboratory biomarker analysis: Correlative studies"
1248329|NCT00095563|O1|Outcome|Treatment (Lapatinib Ditosylate)|"Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~lapatinib ditosylate: Given orally~laboratory biomarker analysis: Correlative studies"
1248330|NCT00095563|O1|Outcome|Treatment (Lapatinib Ditosylate)|"Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~lapatinib ditosylate: Given orally~laboratory biomarker analysis: Correlative studies"
1248331|NCT00095563|O1|Outcome|Treatment (Lapatinib Ditosylate)|"Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~lapatinib ditosylate: Given orally~laboratory biomarker analysis: Correlative studies"
1248332|NCT00095563|O1|Outcome|Treatment (Lapatinib Ditosylate)|"Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~lapatinib ditosylate: Given orally~laboratory biomarker analysis: Correlative studies"
1248333|NCT00095563|O1|Outcome|Treatment (Lapatinib Ditosylate)|"Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~lapatinib ditosylate: Given orally~laboratory biomarker analysis: Correlative studies"
1248334|NCT00095563|O1|Outcome|Treatment (Lapatinib Ditosylate)|"Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~lapatinib ditosylate: Given orally~laboratory biomarker analysis: Correlative studies"
1248335|NCT00095563|E1|Reported Event|Treatment (Lapatinib Ditosylate)|"Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~lapatinib ditosylate: Given orally~laboratory biomarker analysis: Correlative studies"
1248336|NCT00095498|B4|Baseline|Total|Total of all reporting groups
1248337|NCT00095498|B3|Baseline|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248339|NCT00095498|B1|Baseline|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248340|NCT00095498|P3|Participant Flow|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248341|NCT00095498|P2|Participant Flow|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248342|NCT00095498|P1|Participant Flow|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248343|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248344|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248345|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248346|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248347|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248348|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248349|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248350|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248351|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248352|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248353|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248354|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248355|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248356|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248357|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248358|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248359|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248360|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248361|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1249186|NCT00095212|B1|Baseline|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
1248365|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248366|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248367|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248368|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248369|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248370|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248371|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248372|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248373|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248374|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248375|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248376|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248377|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248378|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248379|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248380|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248381|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248382|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248383|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248384|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248385|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248386|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248387|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248388|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248389|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248390|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248391|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248392|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248393|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248394|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248395|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248396|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248397|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248398|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248399|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248400|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248401|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248402|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248403|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248404|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248405|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248406|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248407|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248408|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248409|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248410|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248411|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248412|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248413|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248414|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248415|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248416|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248417|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248418|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248419|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248420|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248421|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248422|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248423|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248424|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248425|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248426|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248427|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248428|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248429|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248430|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248431|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248432|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248433|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248434|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248435|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248436|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248437|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248438|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248439|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248440|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248441|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248442|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248443|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248444|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248445|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248446|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248447|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248448|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248449|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248450|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248451|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248452|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248453|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248454|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248455|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248456|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248457|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248458|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248459|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248460|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248461|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248462|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248463|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248464|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248465|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248466|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248467|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248468|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248469|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248470|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248471|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248472|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248473|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248474|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248475|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248476|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248477|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248478|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248479|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248480|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248481|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248482|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248483|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248484|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248485|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248486|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248487|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248488|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248489|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248490|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248491|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248492|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248493|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248494|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248495|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248496|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248497|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248498|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248499|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248500|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248501|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248502|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248503|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248504|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248505|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248506|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248507|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248508|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248509|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248510|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248511|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248512|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248513|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248514|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248515|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248516|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248517|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248518|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248519|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248520|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248521|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248522|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248523|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248524|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248525|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248526|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248527|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248528|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248529|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248530|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248531|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248532|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248533|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248534|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248535|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248536|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248537|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248538|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248539|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248540|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248541|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248542|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248543|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248544|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248545|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248546|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248547|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248548|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248549|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248550|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248551|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248552|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248553|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248554|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248555|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248556|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248557|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248558|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248559|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248560|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248561|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248562|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248563|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248564|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248565|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248566|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248567|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248568|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248569|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248570|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248571|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248572|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248573|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248574|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248575|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248576|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248577|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248578|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248579|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248580|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248581|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248582|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248583|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248584|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248585|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248586|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248587|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248588|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248589|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248590|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248591|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248592|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248593|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248594|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248595|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248596|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248597|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248598|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248599|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248600|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248601|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248602|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248603|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248604|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248605|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248606|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248607|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248608|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248609|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248610|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248611|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248612|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248613|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248614|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248615|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248616|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248617|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248618|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248619|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248620|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248621|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248622|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248623|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248624|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248625|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248626|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248627|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248628|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248629|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248630|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248631|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248632|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248633|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248634|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248635|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248636|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248637|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248638|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248639|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248640|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248641|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248642|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248643|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248644|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248645|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248646|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248647|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248648|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248649|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248650|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248651|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248652|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248653|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248654|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248655|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248656|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248657|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248658|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248659|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248660|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248661|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248662|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248663|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248664|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248665|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248666|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248667|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248668|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248669|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248670|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248671|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248672|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248673|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248674|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248675|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248676|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248677|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248678|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248679|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248680|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248681|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248682|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248683|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248684|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248685|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248686|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248687|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248688|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248689|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248690|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248691|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248692|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248693|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248694|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248695|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248696|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248697|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248698|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248699|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248700|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248701|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248702|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248703|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248704|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248705|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248706|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248707|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248708|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248709|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248710|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248711|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248712|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248713|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248714|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248715|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248716|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248717|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248718|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248719|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248720|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248721|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248722|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248723|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248724|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248725|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248726|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248727|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248728|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248729|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248730|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248731|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248732|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248733|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248734|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248735|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248736|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248737|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248738|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248739|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248740|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248741|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248742|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248743|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248744|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248745|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248746|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248747|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248748|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248749|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248750|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248751|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248752|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248753|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248754|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248755|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248756|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248757|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248758|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248759|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248760|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248761|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248762|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248763|NCT00095498|E3|Reported Event|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248764|NCT00095498|E2|Reported Event|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
1248765|NCT00095498|E1|Reported Event|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
1248766|NCT00095303|B3|Baseline|Total|Total of all reporting groups
1248767|NCT00095303|B2|Baseline|TAU- Treatment as Usual|TAU: Treatment As Usual. Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
1248768|NCT00095303|B1|Baseline|BSFT|BSFT: Brief Strategic Family Therapy. 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members
1248769|NCT00095303|P2|Participant Flow|Treatment as Usual|Treatment as Usual : TAU varies depending on site, however each will offer services that include at least 1 therapy session per week (individual or group therapy) as well as participation in ancillary services (e.g., case management, self help groups, etc.) over a four month period.
1249095|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
1248770|NCT00095303|P1|Participant Flow|BSFT|"Brief Strategic Family Therapy For Adolescent Drug Abusers : BSFT is a family therapy approach that consists of 12 to 16 sessions (each 1 to 1.5 hours long) over a 4-month period, and up to 8 booster sessions. Interventions are delivered to adolescents and relevant family members in non-restrictive community settings (e.g., clinics, homes, school)."
1248771|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
1248772|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
1248773|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
1248774|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
1248775|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
1248776|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
1248777|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
1248778|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
1248779|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
1248780|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
1248781|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
1248782|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
1248783|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
1248784|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
1248785|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
1248786|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
1248787|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
1248788|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
1248789|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
1248790|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
1248791|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
1248792|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
1248793|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
1248794|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
1248795|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
1248796|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
1248797|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
1248798|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
1248799|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
1248800|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
1248801|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
1248802|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
1248803|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
1248804|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
1248805|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
1248806|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
1248807|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
1248808|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
1248809|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
1248810|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
1248811|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
1248812|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
1248813|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
1248814|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
1248815|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
1248816|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
1248817|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
1248818|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
1248819|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
1248820|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
1248821|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
1248822|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
1248823|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
1248824|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
1248825|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
1248826|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
1248827|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
1248828|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
1248829|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
1248830|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
1248831|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
1248832|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
1248833|NCT00095303|E2|Reported Event|Treatment as Usual|Treatment as Usual: TAU varies depending on site, however each will offer services that include at least 1 therapy session per week (individual or group therapy) as well as participation in ancillary services (e.g., case management, self help groups, etc.) over a four month period.
1248834|NCT00095303|E1|Reported Event|BSFT|"Brief Strategic Family Therapy For Adolescent Drug Abusers: BSFT is a family therapy approach that consists of 12 to 16 sessions (each 1 to 1.5 hours long) over a 4-month period, and up to 8 booster sessions. Interventions are delivered to adolescents and relevant family members in non-restrictive community settings (e.g., clinics, homes, school)."
1249126|NCT00095238|O4|Outcome|Placebo no ACE-I Use|
1249127|NCT00095238|O3|Outcome|Irbesartan no ACE-I Use|
1248835|NCT00096538|B1|Baseline|Valganciclovir|Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year.
1248836|NCT00096538|P1|Participant Flow|Valganciclovir|Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year.
1248837|NCT00096538|O1|Outcome|Valganciclovir|Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year.
1248838|NCT00096538|E1|Reported Event|Valganciclovir|Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year.
1248839|NCT00096486|B5|Baseline|Total|Total of all reporting groups
1248840|NCT00096486|B4|Baseline|Phase II: Cohort II One or More Prior Chemotherapy|Phase II: Cohort II one or more prior chemotherapy
1248841|NCT00096486|B3|Baseline|Phase II: Cohort I no Prior Conventional Chemotherapy|Phase II: Cohort I no prior conventional chemotherapy
1248842|NCT00096486|B2|Baseline|Phase I: RAD001 5 mg, Gefitinib 250 mg|Phase I: RAD001 5 mg, Gefitinib 250 mg
1248843|NCT00096486|B1|Baseline|Phase I: RAD001 10 mg, Gefitinib 250 mg|Phase I: RAD001 10 mg, Gefitinib 250 mg
1248844|NCT00096486|P4|Participant Flow|Phase II: Cohort II One or More Prior Chemotherapy|Phase II: Cohort II one or more prior chemotherapy
1248845|NCT00096486|P3|Participant Flow|Phase II: Cohort I no Prior Conventional Chemotherapy|Phase II: Cohort I no prior conventional chemotherapy
1248846|NCT00096486|P2|Participant Flow|Phase I: RAD001 5 mg, Gefitinib 250 mg|Phase I: RAD001 5 mg, Gefitinib 250 mg
1248847|NCT00096486|P1|Participant Flow|Phase I: RAD001 10 mg, Gefitinib 250 mg|Phase I: RAD001 10 mg, Gefitinib 250 mg
1248848|NCT00096486|O4|Outcome|Phase II: Cohort II One or More Prior Chemotherapy|Phase II: Cohort II one or more prior chemotherapy
1248849|NCT00096486|O3|Outcome|Phase II: Cohort I no Prior Conventional Chemotherapy|Phase II: Cohort I no prior conventional chemotherapy
1248850|NCT00096486|O2|Outcome|Phase I: RAD001 5 mg, Gefitinib 250 mg|Phase I: RAD001 5 mg, Gefitinib 250 mg
1248851|NCT00096486|O1|Outcome|Phase I: RAD001 10 mg, Gefitinib 250 mg|Phase I: RAD001 10 mg, Gefitinib 250 mg
1248852|NCT00096486|E4|Reported Event|Phase II: Cohort II One or More Prior Chemotherapy|Phase II: Cohort II one or more prior chemotherapy
1248853|NCT00096486|E3|Reported Event|Phase II: Cohort I no Prior Conventional Chemotherapy|Phase II: Cohort I no prior conventional chemotherapy
1248854|NCT00096486|E2|Reported Event|Phase I: RAD001 5 mg, Gefitinib 250 mg|Phase I: RAD001 5 mg, Gefitinib 250 mg
1248855|NCT00096486|E1|Reported Event|Phase I: RAD001 10 mg, Gefitinib 250 mg|Phase I: RAD001 10 mg, Gefitinib 250 mg
1248856|NCT00096460|B3|Baseline|Total|Total of all reporting groups
1250419|NCT00092677|P1|Participant Flow|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
1248857|NCT00096460|B2|Baseline|Allogeneic Hematopoietic Stem Cell Transplant (HSCT)|Human Leukocyte Antigen (HLA) matched sibling donor HSCT preceded by bone marrow ablation consisting of cyclophosphamide (750mg/m^2/day from day -6 to -4) fludarabine (30mg/m^2/day from day -6 to -4)
1248858|NCT00096460|B1|Baseline|Autologous Hematopoietic Stem Cell Transplant (HSCT)|Autologous HSCT preceded by bone marrow ablation including cyclophosphamide 100mg/kg, etoposide 60mg/kg and either radiation therapy at 1200cGy or carmustine at 15mg/kg
1248859|NCT00096460|P2|Participant Flow|Allogeneic Hematopoietic Stem Cell Transplant (HSCT)|Human Leukocyte Antigen (HLA) matched sibling donor HSCT preceded by bone marrow ablation consisting of cyclophosphamide (750mg/m^2/day from day -6 to -4) fludarabine (30mg/m^2/day from day -6 to -4)
1248860|NCT00096460|P1|Participant Flow|Autologous Hematopoietic Stem Cell Transplant (HSCT)|Autologous HSCT preceded by bone marrow ablation including cyclophosphamide 100mg/kg, etoposide 60mg/kg and either radiation therapy at 1200cGy or carmustine at 15mg/kg
1248861|NCT00096460|O2|Outcome|Allogeneic Hematopoietic Stem Cell Transplant (HSCT)|Human Leukocyte Antigen (HLA) matched sibling donor HSCT preceded by bone marrow ablation consisting of cyclophosphamide (750mg/m^2/day from day -6 to -4) fludarabine (30mg/m^2/day from day -6 to -4)
1248862|NCT00096460|O1|Outcome|Autologous Hematopoietic Stem Cell Transplant (HSCT)|Autologous HSCT preceded by bone marrow ablation including cyclophosphamide 100mg/kg, etoposide 60mg/kg and either radiation therapy at 1200cGy or carmustine at 15mg/kg
1248863|NCT00096460|E2|Reported Event|Allogeneic Hematopoietic Stem Cell Transplant (HSCT)|Human Leukocyte Antigen (HLA) matched sibling donor HSCT preceded by bone marrow ablation consisting of cyclophosphamide (750mg/m^2/day from day -6 to -4) fludarabine (30mg/m^2/day from day -6 to -4)
1248864|NCT00096460|E1|Reported Event|Autologous Hematopoietic Stem Cell Transplant (HSCT)|Autologous HSCT preceded by bone marrow ablation including cyclophosphamide 100mg/kg, etoposide 60mg/kg and either radiation therapy at 1200cGy or carmustine at 15mg/kg
1248865|NCT00096447|B1|Baseline|GW572016|1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
1248866|NCT00096447|P1|Participant Flow|GW572016|1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
1248867|NCT00096447|O1|Outcome|GW572016|1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
1248868|NCT00096447|O1|Outcome|GW572016|1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
1248869|NCT00096447|O1|Outcome|GW572016|1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
1248870|NCT00096447|E1|Reported Event|GW572016|1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
1248871|NCT00096382|B3|Baseline|Total|Total of all reporting groups
1249006|NCT00096018|P1|Participant Flow|Phase I - Dose Escalation|Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
1248872|NCT00096382|B2|Baseline|TBI 200cGy + TIL +HD IL-2, No Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
1248873|NCT00096382|B1|Baseline|TBI 200cGy + TIL +HD IL-2, Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
1248874|NCT00096382|P2|Participant Flow|TBI 200cGy + TIL +HD IL-2, No Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
1248875|NCT00096382|P1|Participant Flow|TBI 200cGy + TIL +HD IL-2, Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
1248876|NCT00096382|O2|Outcome|TBI 200cGy + TIL +HD IL-2, No Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
1248877|NCT00096382|O1|Outcome|TBI 200cGy + TIL +HD IL-2, Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
1248878|NCT00096382|O2|Outcome|TBI 200cGy + TIL +HD IL-2, No Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
1248879|NCT00096382|O1|Outcome|TBI 200cGy + TIL +HD IL-2, Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
1248880|NCT00096382|E2|Reported Event|TBI 200cGy + TIL +HD IL-2, No Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
1248881|NCT00096382|E1|Reported Event|TBI 200cGy + TIL +HD IL-2, Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
1248882|NCT00096356|B3|Baseline|Total|Total of all reporting groups
1248883|NCT00096356|B2|Baseline|Arm 2 - Placebo & Vitamin E|Placebo plus Vitamin E 100mg/day in 3 doses
1248884|NCT00096356|B1|Baseline|Arm 1 - CoQ10 & Vitamin E|CoQ10 plus Vitamin E 100mg/day in 3 doses
1248885|NCT00096356|P2|Participant Flow|Arm 2 - Placebo + Vitamin E|Placebo + Vitamin E 100mg/day in 3 doses
1248886|NCT00096356|P1|Participant Flow|Arm 1 - CoQ10 + Vitamin E|CoQ10 + Vitamin E 100mg/day in 3 doses
1248887|NCT00096356|O2|Outcome|Arm 2 - Placebo & Vitamin E|Placebo-Vitamin E 100 mg/day in 3 doses
1248888|NCT00096356|O1|Outcome|Arm 1- CoQ10 & Vitamin E|CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.
1248889|NCT00096356|O2|Outcome|Arm 2 - Placebo & Vitamin E|Placebo-Vitamin E 100 mg/day in 3 doses
1248890|NCT00096356|O1|Outcome|Arm 1 - CoQ10 & Vitamin E|CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.
1248891|NCT00096356|O2|Outcome|Arm 2 - Placebo & Vitamin E|Placebo-Vitamin E 100 mg/day in 3 doses
1248892|NCT00096356|O1|Outcome|Arm 1 - CoQ10 & Vitamin E|CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.
1248893|NCT00096356|E2|Reported Event|Arm 2 - Placebo & Vitamin E|Placebo-Vitamin E 100 mg/day in 3 doses
1248894|NCT00096356|E1|Reported Event|Arm 1 - CoQ10 & Vitamin E|CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.
1248895|NCT00096278|B3|Baseline|Total|Total of all reporting groups
1248896|NCT00096278|B2|Baseline|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
1248897|NCT00096278|B1|Baseline|Oxaliplatin + Leucovorin + 5-Fluorouracil|Oxaliplatin + Leucovorin + 5-Fluorouracil
1248898|NCT00096278|P2|Participant Flow|Arm 2: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
1248899|NCT00096278|P1|Participant Flow|Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil|Oxaliplatin + Leucovorin + 5-Fluorouracil
1248900|NCT00096278|O2|Outcome|Arm 2: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
1248901|NCT00096278|O1|Outcome|Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil|Oxaliplatin + Leucovorin + 5-Fluorouracil
1248902|NCT00096278|E2|Reported Event|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
1248903|NCT00096278|E1|Reported Event|Oxaliplatin + Leucovorin + 5-Fluorouracil|Oxaliplatin + Leucovorin + 5-Fluorouracil
1248904|NCT00096265|B4|Baseline|Total|Total of all reporting groups
1248905|NCT00096265|B3|Baseline|Erlotinib + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
1248906|NCT00096265|B2|Baseline|Temozolomide + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
1248907|NCT00096265|B1|Baseline|WBRT + SRS|Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
1248908|NCT00096265|P3|Participant Flow|Erlotinib + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
1249128|NCT00095238|O2|Outcome|Placebo + ACE-I Use|
1248909|NCT00096265|P2|Participant Flow|Temozolomide + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
1248910|NCT00096265|P1|Participant Flow|WBRT + SRS|Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
1248911|NCT00096265|O3|Outcome|Erlotinib + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
1248912|NCT00096265|O2|Outcome|Temozolomide + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
1248913|NCT00096265|O1|Outcome|WBRT + SRS|Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
1248914|NCT00096265|E3|Reported Event|Erlotinib+WBRT+SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months. [Data is reported for eligible patients with adverse event information, which is 41 patients.]
1248915|NCT00096265|E2|Reported Event|Temozolomide+WBRT+SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. [Data is reported for eligible patients with adverse event information, which is 39 patients.]
1248916|NCT00096265|E1|Reported Event|WBRT+SRS|Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery. [Data is reported for eligible patients with adverse event information, which is 44 patients.]
1248917|NCT00096226|B1|Baseline|Chemoradiation, Surgery, Chemotherapy|"Chemoradiation, surgery, chemotherapy~carboplatin~paclitaxel~adjuvant therapy~conventional surgery~neoadjuvant therapy~radiation therapy"
1248918|NCT00096226|P1|Participant Flow|Chemoradiation, Surgery, Chemotherapy|Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2.
1248988|NCT00096122|O1|Outcome|Idarubicin, Cytarabine + Tipifarnib|Cytarabine 1.5 g/m^2 and Idarubicin 12 mg/m^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.
1248919|NCT00096226|O1|Outcome|Chemoradiation, Surgery, Chemotherapy|Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2.
1248920|NCT00096226|E1|Reported Event|Chemoradiation, Surgery, Chemotherapy|Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2.
1248921|NCT00096200|B4|Baseline|Total|Total of all reporting groups
1248922|NCT00096200|B3|Baseline|Arm C|Patients from Arm A that had progressive disease were eligible to crossover to Arm B
1248923|NCT00096200|B2|Baseline|Arm B|Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1248924|NCT00096200|B1|Baseline|Arm A|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression crossover to arm II
1248925|NCT00096200|P3|Participant Flow|Arm C|Patients from Arm A that had progressive disease were eligible to crossover to Arm B
1248926|NCT00096200|P2|Participant Flow|Arm B|Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1248927|NCT00096200|P1|Participant Flow|Arm A|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression crossover to arm II
1248928|NCT00096200|O3|Outcome|Arm C: Crossover From Arm A to B|Cross-over arm: Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1248929|NCT00096200|O2|Outcome|Arm B|Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1248930|NCT00096200|O1|Outcome|Arm A|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression after 2 cycles of treatment may crossover to arm B.
1248931|NCT00096200|E3|Reported Event|Arm C|Patients from Arm A that had progressive disease were eligible to crossover to Arm B
1249129|NCT00095238|O1|Outcome|Irbesartan + ACE-I Use|
1248932|NCT00096200|E2|Reported Event|Arm B|Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1248933|NCT00096200|E1|Reported Event|Arm A|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression crossover to arm II
1248934|NCT00096174|B1|Baseline|Cisplatin, C225, Radiation|"Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.~Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.~Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months."
1248935|NCT00096174|P1|Participant Flow|Cisplatin, C225, Radiation|"Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.~Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.~Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months."
1248936|NCT00096174|O1|Outcome|Cisplatin, C225, Radiation|"Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.~Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.~Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months."
1248937|NCT00096174|O1|Outcome|Cisplatin, C225, Radiation|"Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.~Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.~Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months."
1248938|NCT00096174|O1|Outcome|Cisplatin, C225, Radiation|"Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.~Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.~Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months."
1250420|NCT00092677|O2|Outcome|Placebo|
1248939|NCT00096174|E1|Reported Event|Cisplatin, C225, Radiation|"Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.~Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.~Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months."
1248940|NCT00096161|B5|Baseline|Total|Total of all reporting groups
1248941|NCT00096161|B4|Baseline|Group 2C (Pentostatin, DLI Dose Level 2, Add'l IS)|"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248942|NCT00096161|B3|Baseline|Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)|"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248943|NCT00096161|B2|Baseline|Group 1B (Pentostatin, DLI Dose Level 2)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248944|NCT00096161|B1|Baseline|Group 1A (Pentostatin, DLI Dose Level 1)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248945|NCT00096161|P4|Participant Flow|Group 2C (Pentostatin, DLI Dose Level 2, Add'l IS)|"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248946|NCT00096161|P3|Participant Flow|Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)|"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248947|NCT00096161|P2|Participant Flow|Group 1B (Pentostatin, DLI Dose Level 2)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1249184|NCT00095212|B3|Baseline|Total|Total of all reporting groups
1248948|NCT00096161|P1|Participant Flow|Group 1A (Pentostatin, DLI Dose Level 1)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248949|NCT00096161|O4|Outcome|Group 2C (Pentostatin, DLI Dose Level 2, Add'l IS)|"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248950|NCT00096161|O3|Outcome|Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)|"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248951|NCT00096161|O2|Outcome|Group 1B (Pentostatin, DLI Dose Level 2)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248952|NCT00096161|O1|Outcome|Group 1A (Pentostatin, DLI Dose Level 1)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248953|NCT00096161|O4|Outcome|Group 2C (Pentostatin, DLI Dose Level 2, Add'l IS)|"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248954|NCT00096161|O3|Outcome|Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)|"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248955|NCT00096161|O2|Outcome|Group 1B (Pentostatin, DLI Dose Level 2)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248956|NCT00096161|O1|Outcome|Group 1A (Pentostatin, DLI Dose Level 1)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248957|NCT00096161|O4|Outcome|Group 2C (Pentostatin, DLI Dose Level 2, Add'l IS)|"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248958|NCT00096161|O3|Outcome|Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)|"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248959|NCT00096161|O2|Outcome|Group 1B (Pentostatin, DLI Dose Level 2)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248960|NCT00096161|O1|Outcome|Group 1A (Pentostatin, DLI Dose Level 1)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248961|NCT00096161|O4|Outcome|Group 2C (Pentostatin, DLI Dose Level 2, Add'l IS)|"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248962|NCT00096161|O3|Outcome|Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)|"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248963|NCT00096161|O2|Outcome|Group 1B (Pentostatin, DLI Dose Level 2)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1249007|NCT00096018|O2|Outcome|Phase II|Thalidomide 200 mg/day on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
1249185|NCT00095212|B2|Baseline|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
1248964|NCT00096161|O1|Outcome|Group 1A (Pentostatin, DLI Dose Level 1)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248965|NCT00096161|O4|Outcome|Group 2C (Pentostatin, DLI Dose Level 2, Add'l IS)|"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248966|NCT00096161|O3|Outcome|Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)|"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248967|NCT00096161|O2|Outcome|Group 1B (Pentostatin, DLI Dose Level 2)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248968|NCT00096161|O1|Outcome|Group 1A (Pentostatin, DLI Dose Level 1)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248969|NCT00096161|O4|Outcome|Group 2C (Pentostatin, DLI Dose Level 2, Add'l IS)|"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248970|NCT00096161|O3|Outcome|Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)|"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248971|NCT00096161|O2|Outcome|Group 1B (Pentostatin, DLI Dose Level 2)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248972|NCT00096161|O1|Outcome|Group 1A (Pentostatin, DLI Dose Level 1)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248973|NCT00096161|E4|Reported Event|Group 2C (Pentostatin, DLI Dose Level 2, Add'l IS)|"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248974|NCT00096161|E3|Reported Event|Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)|"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248975|NCT00096161|E2|Reported Event|Group 1B (Pentostatin, DLI Dose Level 2)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248976|NCT00096161|E1|Reported Event|Group 1A (Pentostatin, DLI Dose Level 1)|"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.~Pentostatin: Given IV~Therapeutic Allogeneic Lymphocytes: Given IV"
1248977|NCT00096135|B3|Baseline|Total|Total of all reporting groups
1248978|NCT00096135|B2|Baseline|Testicular Relapse Patients (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
1248979|NCT00096135|B1|Baseline|CNS Patients - Treatment (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
1249008|NCT00096018|O1|Outcome|Phase I - Dose Escalation|Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
1249009|NCT00096018|O2|Outcome|Phase II|Thalidomide 200 mg/day on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
1248980|NCT00096135|P2|Participant Flow|Testicular Relapse Patients (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
1248981|NCT00096135|P1|Participant Flow|CNS Patients - Treatment (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
1248982|NCT00096135|O2|Outcome|Testicular Relapse Patients (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
1248983|NCT00096135|O1|Outcome|CNS Patients - Treatment (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
1248984|NCT00096135|E2|Reported Event|Testicular Relapse Patients (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
1248985|NCT00096135|E1|Reported Event|CNS Patients - Treatment (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
1248986|NCT00096122|B1|Baseline|Idarubicin, Cytarabine + Tipifarnib|Cytarabine 1.5 g/m^2 and Idarubicin 12 mg/m^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.
1248987|NCT00096122|P1|Participant Flow|Idarubicin, Cytarabine + Tipifarnib|Cytarabine 1.5 g/m^2 and Idarubicin 12 mg/m^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.
1248989|NCT00096122|E1|Reported Event|Idarubicin, Cytarabine + Tipifarnib|Cytarabine 1.5 g/m^2 and Idarubicin 12 mg/m^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.
1248990|NCT00096109|B1|Baseline|Treatment (Tanespimycin)|Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1248991|NCT00096109|P1|Participant Flow|Treatment (Tanespimycin)|"Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis: Correlative studies (was not completed due to the small number of samples)"
1248992|NCT00096109|O1|Outcome|Treatment (Tanespimycin)|"Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis: Correlative studies (was not completed due to the small number of samples)"
1248993|NCT00096109|O1|Outcome|Treatment (Tanespimycin)|"Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis: Correlative studies (was not completed due to the small number of samples)"
1248994|NCT00096109|O1|Outcome|Treatment (Tanespimycin)|"Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis: Correlative studies (was not completed due to the small number of samples)"
1248995|NCT00096109|E1|Reported Event|Treatment (Tanespimycin)|"Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~tanespimycin: Given IV~laboratory biomarker analysis: Correlative studies"
1248996|NCT00096031|B1|Baseline|Cetuximab|250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.
1248997|NCT00096031|P1|Participant Flow|Cetuximab|250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.
1248998|NCT00096031|O1|Outcome|Cetuximab|250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.
1248999|NCT00096031|O1|Outcome|Cetuximab|250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.
1249000|NCT00096031|O1|Outcome|Cetuximab|250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.
1249001|NCT00096031|E1|Reported Event|Cetuximab|
1249002|NCT00096018|B3|Baseline|Total|Total of all reporting groups
1249003|NCT00096018|B2|Baseline|Phase II|Thalidomide 200 mg/day on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
1249004|NCT00096018|B1|Baseline|Phase I - Dose Escalation|Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
1249005|NCT00096018|P2|Participant Flow|Phase II|Thalidomide 200 mg/day on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
1249092|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
1249010|NCT00096018|O1|Outcome|Phase I - Dose Escalation|Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
1249011|NCT00096018|E2|Reported Event|Phase II|Thalidomide 200 mg/day on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
1249012|NCT00096018|E1|Reported Event|Phase I - Dose Escalation|Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
1249013|NCT00095979|B1|Baseline|Ixabepilone|Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
1249014|NCT00095979|P1|Participant Flow|Ixabepilone|Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
1249015|NCT00095979|O1|Outcome|Ixabepilone|Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
1249016|NCT00095979|O1|Outcome|Ixabepilone|Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
1249017|NCT00095979|O1|Outcome|Ixabepilone|Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
1249018|NCT00095979|E1|Reported Event|Ixabepilone|Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
1249019|NCT00095940|B8|Baseline|Total|Total of all reporting groups
1249020|NCT00095940|B7|Baseline|Ependymoma: No Surgery|Participants with recurrent ependymoma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.
1249021|NCT00095940|B6|Baseline|Ependymoma: No Lapatnib Prior to Surgery|Participants with recurrent ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives.
1249022|NCT00095940|B5|Baseline|Ependymoma: Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives.
1249023|NCT00095940|B4|Baseline|High Grade Glioma: No Surgery|Participants with recurrent high grade glioma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.
1249024|NCT00095940|B3|Baseline|Medulloblastoma: No Surgery|Participants with recurrent medulloblastoma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.
1249025|NCT00095940|B2|Baseline|Medulloblastoma: No Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives.
1249052|NCT00095940|E4|Reported Event|High Grade Glioma: No Surgery|Participants with recurrent high grade glioma who did not have surgical resection of the tumor at study enrollment.
1249026|NCT00095940|B1|Baseline|Medulloblastoma: Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives.
1249027|NCT00095940|P9|Participant Flow|Ependymoma: No Surgery|Participants with recurrent ependymoma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.
1249028|NCT00095940|P8|Participant Flow|Ependymoma: No Lapatnib Prior to Surgery|Participants with recurrent ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives.
1249029|NCT00095940|P7|Participant Flow|Ependymoma: Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives.
1249030|NCT00095940|P6|Participant Flow|High Grade Glioma: No Surgery|Participants with recurrent high grade glioma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.
1249031|NCT00095940|P5|Participant Flow|High Grade Glioma: No Lapatinib Prior to Surgery|Participants with recurrent high grade glioma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives.
1249032|NCT00095940|P4|Participant Flow|High Grade Glioma: Lapatinib Prior to Surgery|Participants with recurrent high grade glioma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives.
1249033|NCT00095940|P3|Participant Flow|Medulloblastoma: No Surgery|Participants with recurrent medulloblastoma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.
1249034|NCT00095940|P2|Participant Flow|Medulloblastoma: No Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives.
1249035|NCT00095940|P1|Participant Flow|Medulloblastoma: Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives.
1249036|NCT00095940|O3|Outcome|Recurrent Ependymoma|Participants with recurrent ependymoma who provided formalin fixed paraffin embedded tumor material prior to treatment were included in the analysis population.
1249037|NCT00095940|O2|Outcome|Recurrent High Grade Glioma|Participants with recurrent high grade glioma who provided formalin fixed paraffin embedded tumor material prior to treatment were included in the analysis population.
1249038|NCT00095940|O1|Outcome|Recurrent Medulloblastoma|Participants with recurrent medulloblastoma who provided formalin fixed paraffin embedded tumor material prior to treatment were included in the analysis population.
1249039|NCT00095940|O3|Outcome|Recurrent Ependymoma|Participants with recurrent ependymoma who provided formalin fixed paraffin embedded tumor material prior to treatment were included in the analysis population.
1249040|NCT00095940|O2|Outcome|Recurrent High Grade Glioma|Participants with recurrent high grade glioma who provided formalin fixed paraffin embedded tumor material prior to treatment were included in the analysis population.
1249041|NCT00095940|O1|Outcome|Recurrent Medulloblastoma|Participants with recurrent medulloblastoma who provided formalin fixed paraffin embedded tumor material prior to treatment were included in the analysis population.
1249042|NCT00095940|O1|Outcome|Lapatinib: No Surgery|Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who 1)were randomized to not receive lapatinib prior to surgery and had measureable disease after surgical resection or 2) did not have surgical resection of the tumor at study enrollment
1249043|NCT00095940|O1|Outcome|Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery.
1249044|NCT00095940|O3|Outcome|Recurrent Ependymoma|Participants with recurrent ependymoma who 1)were randomized to not receive lapatinib prior to surgery and had measureable disease after surgical resection or 2) did not have surgical resection of the tumor at study enrollment.
1249045|NCT00095940|O2|Outcome|Recurrent High Grade Glioma|Participants with recurrent high grade glioma who 1)were randomized to not receive lapatinib prior to surgery and had measureable disease after surgical resection or 2) did not have surgical resection of the tumor at study enrollment.
1249046|NCT00095940|O1|Outcome|Recurrent Medulloblastoma|Participants with recurrent medulloblastoma who 1)were randomized to not receive lapatinib prior to surgery and had measureable disease after surgical resection or 2) did not have surgical resection of the tumor at study enrollment.
1249047|NCT00095940|O2|Outcome|No Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery.
1249048|NCT00095940|O1|Outcome|Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery.
1249049|NCT00095940|E7|Reported Event|Ependymoma: No Surgery|Participants with recurrent ependymoma who did not have surgical resection of the tumor at study enrollment and were not eligible for the randomization to receive lapatinib or not prior to surgery.
1249050|NCT00095940|E6|Reported Event|Ependymoma: No Lapatnib Prior to Surgery|Participants with recurrent ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery.
1249051|NCT00095940|E5|Reported Event|Ependymoma: Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery.
1249948|NCT00094536|O1|Outcome|Extended Treatment Regimen|Extended treatment regimens using the Her Option Endometrial Cryotherapy System.
1249053|NCT00095940|E3|Reported Event|Medulloblastoma: No Surgery|Participants with recurrent medulloblastoma who did not have surgical resection of the tumor at study enrollment.
1249054|NCT00095940|E2|Reported Event|Medulloblastoma: No Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib prior to surgery.
1249055|NCT00095940|E1|Reported Event|Medulloblastoma: Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery.
1249056|NCT00095875|B3|Baseline|Total|Total of all reporting groups
1249057|NCT00095875|B2|Baseline|Arm II|"Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks"
1249058|NCT00095875|B1|Baseline|Arm I|"Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks~carboplatin : Given IV~fluorouracil : Given IV~docetaxel : Given IV"
1249059|NCT00095875|P2|Participant Flow|Arm II|"Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks"
1249060|NCT00095875|P1|Participant Flow|Arm I|"Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks~carboplatin : Given IV~fluorouracil : Given IV~docetaxel : Given IV"
1249061|NCT00095875|O2|Outcome|Arm II|"Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks"
1249093|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
1249094|NCT00095784|O1|Outcome|Arm I|"Patients receive decitabine subcutaneously on days 1-5 and 8-12.~decitabine: Given SC"
1249062|NCT00095875|O1|Outcome|Arm I|"Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks~carboplatin : Given IV~fluorouracil : Given IV~docetaxel : Given IV"
1249063|NCT00095875|O2|Outcome|Arm II|"Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks"
1249064|NCT00095875|O1|Outcome|Arm I|"Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks~carboplatin : Given IV~fluorouracil : Given IV~docetaxel : Given IV"
1249065|NCT00095875|E2|Reported Event|Arm II|"Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks"
1249066|NCT00095875|E1|Reported Event|Arm I|"Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks~carboplatin : Given IV~fluorouracil : Given IV~docetaxel : Given IV"
1249067|NCT00095836|B1|Baseline|Gefitinib 250mg|Gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
1249068|NCT00095836|P1|Participant Flow|Gefitinib 250mg|gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
1249069|NCT00095836|O1|Outcome|Gefitinib 250mg|gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
1249070|NCT00095836|O1|Outcome|Gefitinib 250mg|gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
1249071|NCT00095836|O1|Outcome|Gefitinib 250mg|gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
1249072|NCT00095836|O1|Outcome|Gefitinib 250mg|gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
1249073|NCT00095836|E1|Reported Event|Gefitinib 250mg|gefitinib: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.
1249074|NCT00095784|B1|Baseline|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
1249075|NCT00095784|P1|Participant Flow|Decitabine|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
1249076|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
1249077|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
1249078|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
1249079|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
1249080|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
1249081|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
1249082|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
1249083|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
1249084|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
1249085|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
1249086|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
1249087|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
1249088|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
1249089|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
1249090|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
1249091|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
1249096|NCT00095784|E1|Reported Event|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
1249097|NCT00095628|B1|Baseline|Treatment (Ispinesib)|"Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1249098|NCT00095628|P1|Participant Flow|Treatment (Ispinesib)|"Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1249099|NCT00095628|O1|Outcome|Treatment (Ispinesib)|"Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1249100|NCT00095628|O1|Outcome|Treatment (Ispinesib)|"Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1249101|NCT00095628|O1|Outcome|Treatment (Ispinesib)|"Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1249102|NCT00095628|O1|Outcome|Treatment (Ispinesib)|"Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1249103|NCT00095628|O1|Outcome|Treatment (Ispinesib)|"Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1249104|NCT00095628|O1|Outcome|Treatment (Ispinesib)|"Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1249105|NCT00095628|E1|Reported Event|Treatment (Ispinesib)|"Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1249106|NCT00095576|B3|Baseline|Total|Total of all reporting groups
1249107|NCT00095576|B2|Baseline|Placebo|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
1249108|NCT00095576|B1|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
1249109|NCT00095576|P2|Participant Flow|Placebo|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
1249110|NCT00095576|P1|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
1249111|NCT00095576|O2|Outcome|Placebo|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
1249112|NCT00095576|O1|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
1249113|NCT00095576|O2|Outcome|Placebo|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
1249114|NCT00095576|O1|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
1249115|NCT00095576|O2|Outcome|Placebo|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
1249116|NCT00095576|O1|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
1249117|NCT00095576|O2|Outcome|Placebo|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
1249118|NCT00095576|O1|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
1249119|NCT00095576|E2|Reported Event|Placebo|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
1249120|NCT00095576|E1|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
1249121|NCT00095238|B3|Baseline|Total|Total of all reporting groups
1249122|NCT00095238|B2|Baseline|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
1249123|NCT00095238|B1|Baseline|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
1249124|NCT00095238|P2|Participant Flow|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
1249125|NCT00095238|P1|Participant Flow|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
1249130|NCT00095238|O6|Outcome|Irbesartan - Month 66|Cohort of participants in irbesartan group with GFR assessment at Baseline and Month 66
1249131|NCT00095238|O5|Outcome|Placebo - Month 66|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 66
1249132|NCT00095238|O4|Outcome|Irbesartan - Month 54|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 54
1249133|NCT00095238|O3|Outcome|Placebo - Month 54|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 54
1249134|NCT00095238|O2|Outcome|Irbesartan - Month 42|Cohort of participants in irbesartan group with GFR assessment at Baseline and Month 42
1249135|NCT00095238|O1|Outcome|Placebo - Month 42|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 42
1249136|NCT00095238|O6|Outcome|Irbesartan - Month 30|Cohort of participants in irbesartan group with GFR assessment at Baseline and Month 30
1249137|NCT00095238|O5|Outcome|Placebo - Month 30|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 30
1249138|NCT00095238|O4|Outcome|Irbesartan - Month 18|Cohort of participants in irbesartan group with GFR assessment at Baseline and Month 18
1249139|NCT00095238|O3|Outcome|Placebo - Month 18|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 18
1249140|NCT00095238|O2|Outcome|Irbesartan - Month 6|Cohort of participants in irbesartan group with GFR assessment at Baseline and Month 6
1249141|NCT00095238|O1|Outcome|Placebo - Month 6|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 6
1249142|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
1249143|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
1249144|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
1249145|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
1249146|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
1249147|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
1249148|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
1249149|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
1249150|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
1249151|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
1249152|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
1249153|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
1249154|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
1249155|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
1249156|NCT00095238|O6|Outcome|Placebo Baseline All Classes Combined|
1249157|NCT00095238|O5|Outcome|Placebo Class III or IV|
1249158|NCT00095238|O4|Outcome|Placebo Baseline Class I or II|
1249159|NCT00095238|O3|Outcome|Irbesartan Baseline All Classes Combined|
1249160|NCT00095238|O2|Outcome|Irbesartan Class III or IV|Class III (Moderate): Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV (Severe): Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased.
1249161|NCT00095238|O1|Outcome|Irbesartan Baseline Class I or II|Class I (Mild): No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath). Class II (Mild): Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea.
1249162|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
1249163|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
1249164|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
1249165|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
1249166|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
1249167|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
1249168|NCT00095238|O4|Outcome|Irbesartan - Month 14|Irbesartan cohort with measurements at Baseline and Month 14.
1249169|NCT00095238|O3|Outcome|Placebo - Month 14|Placebo cohort with measurements at Baseline and Month 14.
1249170|NCT00095238|O2|Outcome|Irbesartan - Month 6|Irbesartan cohort with measurements at Baseline and Month 6.
1249171|NCT00095238|O1|Outcome|Placebo - Month 6|Placebo cohort with measurements at baseline and Month 6.
1249172|NCT00095238|O2|Outcome|Irbesartan - Final Visit|Cohort of participants in Irbesartan group with MLwHF scores at Baseline and Final Visit
1249173|NCT00095238|O1|Outcome|Placebo - Final Visit|Cohort of participants in Placebo group with MLwHF scores at Baseline and Final Visit
1249174|NCT00095238|O4|Outcome|Irbesartan - Month 14|Cohort of participants in Irbesartan group with MLwHF scores at Baseline and Month 14
1249175|NCT00095238|O3|Outcome|Placebo - Month 14|Cohort of participants in Placebo group with MLwHF scores at Baseline and Month 14
1249176|NCT00095238|O2|Outcome|Irbesartan - Month 6|Cohort of participants in Irbesartan group with MLwHF scores at Baseline and Month 6
1249177|NCT00095238|O1|Outcome|Placebo - Month 6|Cohort of participants in Placebo group with MLwHF scores at Baseline and Month 6
1249178|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
1249179|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
1249180|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
1249181|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
1249182|NCT00095238|E2|Reported Event|PLACEBO|titration from 75 to 300 mg, once daily (QD), up to 6 years
1249183|NCT00095238|E1|Reported Event|IRBESARTAN|titration from 75 to 300 mg, once daily (QD), up to 6 years
1249187|NCT00095212|P2|Participant Flow|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
1249188|NCT00095212|P1|Participant Flow|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
1249189|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
1249190|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
1249191|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
1249192|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
1249193|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
1249194|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
1249195|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
1249196|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
1249197|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
1249198|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
1249199|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
1249200|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
1249201|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
1249202|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
1249203|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
1249204|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
1249205|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
1249206|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
1249207|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
1249208|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
1249209|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
1249210|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
1249211|NCT00095212|E2|Reported Event|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
1249212|NCT00095212|E1|Reported Event|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
1249213|NCT00095199|B5|Baseline|Total|Total of all reporting groups
1249214|NCT00095199|B4|Baseline|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
1249215|NCT00095199|B3|Baseline|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
1249216|NCT00095199|B2|Baseline|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
1249217|NCT00095199|B1|Baseline|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
1249218|NCT00095199|P4|Participant Flow|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
1249219|NCT00095199|P3|Participant Flow|Cetuximab and Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
1249220|NCT00095199|P2|Participant Flow|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 week cycle for up to six (3-week) cycles.
1249221|NCT00095199|P1|Participant Flow|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles, until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
1249222|NCT00095199|O4|Outcome|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
1249223|NCT00095199|O3|Outcome|Cetuximab + Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Day 1 of every 3 weeks cycle for up to six (3-week) cycles, after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m2 administered intravenously on Day 1 of 3 week cycle for up to six (3-week) cycles.
1249224|NCT00095199|O2|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
1249225|NCT00095199|O1|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week cycles) until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
1249226|NCT00095199|O4|Outcome|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
1249227|NCT00095199|O3|Outcome|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m2 (initial/weekly) administered intravenously every 3 weeks cycle for up to six (3-week) cycles, after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week cycles).
1250445|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
1249228|NCT00095199|O2|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
1249229|NCT00095199|O1|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week cycles).
1249230|NCT00095199|O4|Outcome|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
1249231|NCT00095199|O3|Outcome|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously every 3 weeks cycle for up to six (3-week cycles), after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
1249232|NCT00095199|O2|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
1249233|NCT00095199|O1|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
1249234|NCT00095199|O4|Outcome|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
1249235|NCT00095199|O3|Outcome|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously every 3 weeks cycle for up to six (3-week) cycles, after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
1249236|NCT00095199|O2|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
1249237|NCT00095199|O1|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
1249238|NCT00095199|O4|Outcome|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
1249239|NCT00095199|O3|Outcome|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously every 3 weeks cycle for up to six (3-week) cycles, after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
1249240|NCT00095199|O2|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
1249241|NCT00095199|O1|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week cycles).
1249242|NCT00095199|O4|Outcome|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
1249243|NCT00095199|O3|Outcome|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously every 3 weeks cycle for up to six (3-week) cycles, after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
1249244|NCT00095199|O2|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
1249245|NCT00095199|O1|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
1249246|NCT00095199|O4|Outcome|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
1249247|NCT00095199|O3|Outcome|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously every 3 weeks cycle for up to six (3-week) cycles, after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
1249248|NCT00095199|O2|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
1249249|NCT00095199|O1|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
1249250|NCT00095199|O4|Outcome|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
1249251|NCT00095199|O3|Outcome|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously every 3 weeks cycle for up to six (3-week) cycles, after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
1249252|NCT00095199|O2|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
1249253|NCT00095199|O1|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week cycles).
1249254|NCT00095199|E4|Reported Event|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
1249255|NCT00095199|E3|Reported Event|Cetuximab and Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
1249256|NCT00095199|E2|Reported Event|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 week cycle for up to six (3-week) cycles.
1249257|NCT00095199|E1|Reported Event|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles, until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
1249258|NCT00095173|B1|Baseline|Abatacept (All Participants in Period A)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes,once every 2 weeks for 3 doses, then monthly up to 6 months unless a disease flare discontinued the patient earlier.
1249259|NCT00095173|P6|Participant Flow|Placebo (Period B) to Abatacept (Period C)|Participants from Period B Placebo group entering Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
1249260|NCT00095173|P5|Participant Flow|Abatacept (Period C)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
1249261|NCT00095173|P4|Participant Flow|Abatacept (Period A Non-Responders in Period C)|Participants not eligible to continue into Period B but re-entered in Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) or once a month for up to 5 years (Period C).
1249262|NCT00095173|P3|Participant Flow|Placebo (Period B)|Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
1249263|NCT00095173|P2|Participant Flow|Abatacept (Period B)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare (Period B).
1249264|NCT00095173|P1|Participant Flow|Abatacept (All Participants in Period A)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every 2 weeks for 3 doses.
1249265|NCT00095173|O3|Outcome|Placebo (Period B) to Abatacept (Period C)|Participants from Period B Placebo group entering Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
1249266|NCT00095173|O2|Outcome|Abatacept (Period C)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
1249291|NCT00095173|O1|Outcome|Abatacept (Period B)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare.
1249267|NCT00095173|O1|Outcome|Abatacept (Period A Non-Responders in Period C)|Participants not eligible to continue into Period B but re-entered in Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) and once a month for up to 5 years (Period C).
1249268|NCT00095173|O1|Outcome|Abatacept (All Participants in Period C)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
1249269|NCT00095173|O2|Outcome|Placebo (Period B)|Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
1249270|NCT00095173|O1|Outcome|Abatacept (Period B)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare.
1249271|NCT00095173|O1|Outcome|Abatacept (All Participants in Period A)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses.
1249272|NCT00095173|O3|Outcome|Placebo (Period B) to Abatacept (Period C)|Participants from Period B Placebo group entering Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
1249273|NCT00095173|O2|Outcome|Abatacept (Period C)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
1249274|NCT00095173|O1|Outcome|Abatacept (Period A Non-Responders in Period C)|Participants not eligible to continue into Period B but re-entered in Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) and once a month for up to 5 years (Period C).
1249275|NCT00095173|O1|Outcome|Abatacept (All Participants in Period C)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
1249276|NCT00095173|O2|Outcome|Placebo (Period B)|Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
1249277|NCT00095173|O1|Outcome|Abatacept (Period B)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare.
1249278|NCT00095173|O1|Outcome|Abatacept (All Participants in Period A)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every 2 weeks for 3 doses.
1249279|NCT00095173|O3|Outcome|Placebo (Period B) to Abatacept (Period C)|Participants from Period B Placebo group entering Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
1249280|NCT00095173|O2|Outcome|Abatacept (Period C)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
1249281|NCT00095173|O1|Outcome|Abatacept (Period A Non-Responders in Period C)|Participants not eligible to continue into Period B but re-entered in Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) and once a month for up to 5 years (Period C).
1249282|NCT00095173|O2|Outcome|Placebo (Period B)|Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
1249283|NCT00095173|O1|Outcome|Abatacept (Period B)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare.
1249284|NCT00095173|O3|Outcome|Placebo (Period B) to Abatacept (Period C)|Participants from Period B Placebo group entering Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
1249285|NCT00095173|O2|Outcome|Abatacept (Period C)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
1249286|NCT00095173|O1|Outcome|Abatacept (Period A Non-Responders in Period C)|Participants not eligible to continue into Period B but re-entered in Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) and once a month for up to 5 years (Period C).
1249287|NCT00095173|O2|Outcome|Placebo (Period B)|Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
1249288|NCT00095173|O1|Outcome|Abatacept (Period B)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare.
1249289|NCT00095173|O1|Outcome|Abatacept (All Participants in Period A)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every 2 weeks for 3 doses.
1249290|NCT00095173|O2|Outcome|Placebo (Period B)|Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
1250421|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
1249292|NCT00095173|O2|Outcome|Placebo (Period B)|Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
1249293|NCT00095173|O1|Outcome|Abatacept (Period B)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare.
1249294|NCT00095173|E4|Reported Event|Abatacept (Period A)/Placebo (Period B)|"All participants treated with Abatacept in Period A, placebo in Period B, who may or may not have entered Period C.~Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion. If participants entered Period C, they were treated with Abatacept,10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years."
1249295|NCT00095173|E3|Reported Event|Abatacept (Period A/Period B)|"All participants treated with Abatacept in Periods A and B who may or may not have entered Period C.~Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every 2 weeks for 3 doses, then once a month for 6 months. If participants entered Period C, treatment continued once a month for up to 5 years."
1249296|NCT00095173|E2|Reported Event|Abatacept (Period A/Period C)|"Participants treated in Period A, not eligible to continue into Period B, but re-entered in Period C.~Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) and once a month for up to 5 years (Period C)."
1249297|NCT00095173|E1|Reported Event|Abatacept (Only Period A)|"Participants treated in Period A but did not in Periods B or C.~Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every 2 weeks for 3 doses."
1249298|NCT00095147|B4|Baseline|Total|Total of all reporting groups
1249299|NCT00095147|B3|Baseline|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249300|NCT00095147|B2|Baseline|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249301|NCT00095147|B1|Baseline|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249302|NCT00095147|P5|Participant Flow|ABA + MTX [Open-label (OL)]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
1249303|NCT00095147|P4|Participant Flow|PLA Switched to ABA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
1249304|NCT00095147|P3|Participant Flow|Placebo (PLA) + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249305|NCT00095147|P2|Participant Flow|Infliximab (INF) + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249306|NCT00095147|P1|Participant Flow|Abatacept (ABA) + Methotrexate (MTX) [Double-blind (DB)]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249307|NCT00095147|O1|Outcome|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
1249308|NCT00095147|O1|Outcome|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
1249309|NCT00095147|O1|Outcome|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
1249310|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249311|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249312|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249313|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249314|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249315|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249316|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249317|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249479|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1250422|NCT00092677|O2|Outcome|Placebo|
1249318|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249319|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249320|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249321|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249322|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249323|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249324|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249325|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249326|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249327|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249328|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249329|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249330|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249331|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249332|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1250446|NCT00092677|O2|Outcome|Placebo|
1249333|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249334|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249335|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249336|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249337|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249338|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249339|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249340|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249341|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249342|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249343|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249344|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249557|NCT00094900|P1|Participant Flow|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249345|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249346|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249347|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249348|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249349|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249350|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249351|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249352|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249353|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249354|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249355|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249356|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249357|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249358|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249359|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249386|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249360|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249361|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249362|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249363|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249364|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249365|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249366|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249367|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249368|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249369|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249370|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249371|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249372|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249373|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249374|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249375|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249376|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
1249377|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249378|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249379|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249380|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249381|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants <60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants >100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249382|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
1249383|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249384|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249385|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
1250447|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
1249387|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249388|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249389|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249390|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants <60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants >100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249391|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249392|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249393|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants <60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants >100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249394|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249395|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249396|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249397|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249398|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249399|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249400|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249401|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249402|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249403|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249404|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249405|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249406|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249407|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249408|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249409|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249410|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249411|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249412|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249413|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249468|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1250448|NCT00092677|O2|Outcome|Placebo|
1249414|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249415|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249416|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249417|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249418|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249419|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249420|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249421|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249422|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249423|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249424|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249425|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249426|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249427|NCT00095147|O1|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249428|NCT00095147|O2|Outcome|PLA Switched to ABA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
1249429|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249430|NCT00095147|O3|Outcome|PLA Switched to ABA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
1249431|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249432|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249433|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249434|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249435|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249436|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249437|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249438|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249439|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249440|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249441|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249442|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249443|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249444|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249445|NCT00095147|O1|Outcome|PLA Switched to ABA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
1249446|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249447|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249448|NCT00095147|O1|Outcome|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
1249449|NCT00095147|O1|Outcome|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
1249450|NCT00095147|O1|Outcome|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
1249451|NCT00095147|O1|Outcome|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
1249452|NCT00095147|O1|Outcome|PLA Switched to ABA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
1249453|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249454|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249455|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249456|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249457|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249458|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249459|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249460|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249461|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
1249462|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249463|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249464|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249465|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249466|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249467|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
1249469|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249470|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
1249471|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249472|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249473|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249474|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249475|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249476|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
1249477|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249478|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1250267|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
1249480|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249481|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249482|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
1249483|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249484|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249485|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249486|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249487|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249488|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249489|NCT00095147|O1|Outcome|ABA + MTX [DB[|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249490|NCT00095147|O2|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249491|NCT00095147|O1|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249492|NCT00095147|O2|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
1249493|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249588|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1250449|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
1249494|NCT00095147|E4|Reported Event|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, 104 participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
1249495|NCT00095147|E3|Reported Event|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249496|NCT00095147|E2|Reported Event|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
1249497|NCT00095147|E1|Reported Event|ABA (DB)|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
1249498|NCT00095121|B3|Baseline|Total|Total of all reporting groups
1249499|NCT00095121|B2|Baseline|PLB - ADV|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group. The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
1249500|NCT00095121|B1|Baseline|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to DB ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
1249501|NCT00095121|P2|Participant Flow|PLB - ADV|Placebo (PLB) was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group. The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of open-label (OL) ADV treatment (ADV Week 192). Lamivudine was to be added to the open-label ADV regimen of subjects between 12 and <18 years old who had prior lamivudine exposure and who had a serum HBV DNA concentration >= 1000 copies/mL at 2 consecutive study visits at or after Study Week 96.
1249558|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249502|NCT00095121|P1|Participant Flow|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The adefovir dipivoxil (ADV) baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind [DB] ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240). Lamivudine was to be added to the open-label ADV regimen of subjects between 12 and <18 years old who had prior lamivudine exposure and who had a serum HBV DNA concentration >= 1000 copies/mL at 2 consecutive study visits at or after Study Week 96.
1249503|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
1249504|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
1249505|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
1249506|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
1249507|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
1249589|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249508|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
1249509|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
1249510|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
1249511|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
1249559|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249512|NCT00095121|O2|Outcome|Placebo (PBL)|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group for the double-blind treatment period. RAT included adverse events that occurred up to the last dose of double-blind treatment + 4 days or if discontinued early, 30 days after last double-blind dose.
1249513|NCT00095121|O1|Outcome|Adefovir Dipivoxil (ADV)|Once daily treatment during the double-blind treatment period: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. Randomized and Treated Analysis Set (RAT) included adverse events that occurred up to the last dose of double-blind treatment + 4 days or if discontinued early, 30 days after last double-blind dose.
1249514|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
1249515|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
1249516|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
1249517|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
1249518|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
1249590|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1250307|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
1249519|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
1249520|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
1249521|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
1249522|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
1249523|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
1249524|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
1249525|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
1249526|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
1249527|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
1249528|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
1249591|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249592|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1250308|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
1249529|NCT00095121|O1|Outcome|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to DB ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
1249530|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group. The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
1249531|NCT00095121|O1|Outcome|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to DB ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
1249532|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group. The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
1249533|NCT00095121|O1|Outcome|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to DB ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
1250268|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
1249534|NCT00095121|O1|Outcome|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
1249535|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group. The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
1249536|NCT00095121|O1|Outcome|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to DB ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
1249537|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group. The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
1249538|NCT00095121|O1|Outcome|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to DB ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
1249539|NCT00095121|O2|Outcome|Placebo (PLB)|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group.
1249540|NCT00095121|O1|Outcome|Adefovir Dipivoxil (ADV)|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet.
1249541|NCT00095121|E4|Reported Event|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or hepatitis B surface antigen seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 - 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192). Treatment-emergent AEs for the OL period are events that began on or after the date of the first dose of OL ADV, and include only new events (ie, events that were never observed during the DB period, or, events observed during the DB period but with greater severity during the OL period).
1249553|NCT00095056|O1|Outcome|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with either one (1) 25 mg oral tablet of sitagliptin once daily (blinded) [patients with Creatinine Clearance (CrCl) <30 mL/min or dialysis] or two (2) 25 mg oral tablets of sitagliptin once daily (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Sitagliptin group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide placebo (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
1250450|NCT00092677|O2|Outcome|Placebo|
1249542|NCT00095121|E3|Reported Event|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 - 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to DB ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240). Treatment-emergent AEs for the OL period are events that began on or after the date of the first dose of OL ADV, and include only new events (ie, events that were never observed during the DB period, or, events observed during the DB period but with greater severity during the OL period).
1249543|NCT00095121|E2|Reported Event|PLB (Double-Blind)|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group for the DB treatment period. Treatment-emergent AEs for the DB period are events that occurred up to the last dose of DB treatment + 4 days or if discontinued early, 30 days after last DB dose.
1249544|NCT00095121|E1|Reported Event|ADV (Double-Blind)|Once daily treatment during the DB treatment period: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. Treatment-emergent adverse events (AEs) for the DB period are events that occurred up to the last dose of DB treatment + 4 days or if discontinued early, 30 days after last DB dose.
1249545|NCT00095056|B3|Baseline|Total|Total of all reporting groups
1249560|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249561|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249562|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249791|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
1249546|NCT00095056|B2|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with either one (1) tablet of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl <30 mL/min or dialysis] or two (2) tablets of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Placebo group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
1249547|NCT00095056|B1|Baseline|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with either one (1) 25 mg oral tablet of sitagliptin once daily (blinded) [patients with Creatinine Clearance (CrCl) <30 mL/min or dialysis] or two (2) 25 mg oral tablets of sitagliptin once daily (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Sitagliptin group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide placebo (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
1249548|NCT00095056|P2|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with either one (1) tablet of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl <30 mL/min or dialysis] or two (2) tablets of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Placebo group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
1249549|NCT00095056|P1|Participant Flow|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with either one (1) 25 mg oral tablet of sitagliptin once daily (blinded) [patients with Creatinine Clearance (CrCl) <30 mL/min or dialysis] or two (2) 25 mg oral tablets of sitagliptin once daily (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Sitagliptin group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide placebo (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
1249550|NCT00095056|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with either one (1) tablet of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl <30 mL/min or dialysis] or two (2) tablets of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Placebo group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
1249551|NCT00095056|O1|Outcome|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with either one (1) 25 mg oral tablet of sitagliptin once daily (blinded) [patients with Creatinine Clearance (CrCl) <30 mL/min or dialysis] or two (2) 25 mg oral tablets of sitagliptin once daily (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Sitagliptin group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide placebo (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
1249552|NCT00095056|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with either one (1) tablet of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl <30 mL/min or dialysis] or two (2) tablets of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Placebo group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
1249587|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249554|NCT00095056|E2|Reported Event|Placebo|The Placebo group includes data from patients randomized to receive treatment with either one (1) tablet of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl <30 mL/min or dialysis] or two (2) tablets of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Placebo group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
1249555|NCT00095056|E1|Reported Event|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with either one (1) 25 mg oral tablet of sitagliptin once daily (blinded) [patients with Creatinine Clearance (CrCl) <30 mL/min or dialysis] or two (2) 25 mg oral tablets of sitagliptin once daily (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Sitagliptin group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide placebo (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
1249556|NCT00094900|B1|Baseline|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249929|NCT00094575|O1|Outcome|Endovascular Repair|
1249930|NCT00094575|O2|Outcome|Standard Open Repair|
1249563|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249564|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249565|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249566|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249567|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249568|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249569|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249570|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249571|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249572|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249573|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249574|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249575|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249576|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249577|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249578|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249579|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249580|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249581|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249582|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249583|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249584|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249585|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249586|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1250451|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
1249593|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249594|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249595|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249596|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249597|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249598|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249599|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249600|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249601|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249602|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249603|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249604|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249605|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249606|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249607|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249608|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249609|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249610|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249611|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249612|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249613|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249614|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249615|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249616|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249617|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249618|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249619|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249620|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249621|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249622|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249623|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249624|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249625|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249626|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249627|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249628|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249629|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249630|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249631|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249632|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249633|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249634|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249635|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249636|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249637|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249638|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249639|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249640|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249641|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249642|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249643|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249644|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249645|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249646|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249647|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249648|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249649|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249650|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249651|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249652|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249653|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249654|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249655|NCT00094900|E1|Reported Event|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
1249656|NCT00094887|B3|Baseline|Total|Total of all reporting groups
1249657|NCT00094887|B2|Baseline|Placebo|Nitrogen gas
1249658|NCT00094887|B1|Baseline|Inhaled Nitric Oxide|Inhaled Nitric Oxide INO
1249659|NCT00094887|P2|Participant Flow|Placebo|Nitrogen gas
1249660|NCT00094887|P1|Participant Flow|Inhaled Nitric Oxide|Inhaled Nitric Oxide INO
1249661|NCT00094887|O2|Outcome|Placebo|Nitrogen gas
1249662|NCT00094887|O1|Outcome|Inhaled Nitric Oxide|Inhaled Nitric Oxide INO
1249663|NCT00094887|E2|Reported Event|Placebo|Nitrogen gas
1249664|NCT00094887|E1|Reported Event|Inhaled Nitric Oxide|Inhaled Nitric Oxide INO
1249665|NCT00094861|B3|Baseline|Total|Total of all reporting groups
1249666|NCT00094861|B2|Baseline|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
1249667|NCT00094861|B1|Baseline|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
1249668|NCT00094861|P2|Participant Flow|Palifermin|"Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses. Concurrent radio/chemotherapy (administered for 6 to 7 weeks) was given as follows:~standard radiotherapy 2 Gy once daily x 30 to 33 fractions (6 to 7 weeks) for a total target dose of 60 to 66 Gy~paclitaxel 50 mg/m^2 IV infusion on Days 1, 8, 15, 22, 29, 36 (and day 43 for those receiving 66 Gy)~carboplatin dosed at an area under the curve (AUC) 2.0 IV on Days 1, 8, 15, 22, 29, 36 (and day 43 for those receiving 66 Gy).~Participants subsequently received two 21-day cycles of consolidation chemotherapy with paclitaxel 225 mg/m^2 and carboplatin dosed at AUC 6.0."
1249669|NCT00094861|P1|Participant Flow|Placebo|"Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, for a total of 7 doses. Concurrent radio/chemotherapy was given as follows:~standard radiotherapy 2 Gy once daily x 30 to 33 fractions (6 to 7 weeks) for a total target dose of 60 to 66 Gy~paclitaxel 50 mg/m^2 intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36 (and day 43 for those receiving 66 Gy)~carboplatin dosed at an area under the curve (AUC) 2.0 IV on Days 1, 8, 15, 22, 29, 36 (and day 43 for those receiving 66 Gy).~Participants subsequently received two 21-day cycles of consolidation chemotherapy with paclitaxel 225 mg/m^2 and carboplatin dosed at AUC 6.0."
1249846|NCT00094757|O2|Outcome|Sitagliptin 200 mg|The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
1249670|NCT00094861|O2|Outcome|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
1249671|NCT00094861|O1|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
1249672|NCT00094861|O2|Outcome|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
1249673|NCT00094861|O1|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
1249674|NCT00094861|O2|Outcome|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
1249675|NCT00094861|O1|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
1249676|NCT00094861|O2|Outcome|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
1249677|NCT00094861|O1|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
1249678|NCT00094861|O2|Outcome|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
1249679|NCT00094861|O1|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
1249790|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
1249680|NCT00094861|O2|Outcome|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
1249681|NCT00094861|O1|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
1249682|NCT00094861|O2|Outcome|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
1249683|NCT00094861|O1|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
1249684|NCT00094861|O2|Outcome|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
1249685|NCT00094861|O1|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
1249686|NCT00094861|E2|Reported Event|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
1249687|NCT00094861|E1|Reported Event|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
1249688|NCT00094835|B8|Baseline|Total|Total of all reporting groups
1249689|NCT00094835|B7|Baseline|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249690|NCT00094835|B6|Baseline|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249691|NCT00094835|B5|Baseline|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249692|NCT00094835|B4|Baseline|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249693|NCT00094835|B3|Baseline|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249694|NCT00094835|B2|Baseline|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249695|NCT00094835|B1|Baseline|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1250452|NCT00092677|O2|Outcome|Placebo|
1249696|NCT00094835|P7|Participant Flow|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249697|NCT00094835|P6|Participant Flow|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249698|NCT00094835|P5|Participant Flow|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249699|NCT00094835|P4|Participant Flow|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249700|NCT00094835|P3|Participant Flow|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249701|NCT00094835|P2|Participant Flow|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249702|NCT00094835|P1|Participant Flow|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249703|NCT00094835|O5|Outcome|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249704|NCT00094835|O4|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249705|NCT00094835|O3|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249706|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249707|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249708|NCT00094835|O5|Outcome|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249709|NCT00094835|O4|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249710|NCT00094835|O3|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249711|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249712|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249713|NCT00094835|O4|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249714|NCT00094835|O3|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249715|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1250309|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
1249716|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249717|NCT00094835|O7|Outcome|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249718|NCT00094835|O6|Outcome|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249719|NCT00094835|O5|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249720|NCT00094835|O4|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249721|NCT00094835|O3|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249722|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249931|NCT00094575|O1|Outcome|Endovascular Repair|
1249723|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249724|NCT00094835|O7|Outcome|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249725|NCT00094835|O6|Outcome|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249726|NCT00094835|O5|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249727|NCT00094835|O4|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249728|NCT00094835|O3|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249729|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249730|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249731|NCT00094835|O6|Outcome|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249732|NCT00094835|O5|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249733|NCT00094835|O4|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249734|NCT00094835|O3|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249735|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1250310|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
1249736|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249737|NCT00094835|O6|Outcome|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249738|NCT00094835|O5|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249739|NCT00094835|O4|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249740|NCT00094835|O3|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249741|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249742|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249932|NCT00094575|O2|Outcome|Standard Open Repair|
1249743|NCT00094835|O6|Outcome|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249744|NCT00094835|O5|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249745|NCT00094835|O4|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249746|NCT00094835|O3|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249747|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249748|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249749|NCT00094835|O7|Outcome|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249750|NCT00094835|O6|Outcome|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249751|NCT00094835|O5|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249752|NCT00094835|O4|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249753|NCT00094835|O3|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249754|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249755|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1250311|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
1249756|NCT00094835|O7|Outcome|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249757|NCT00094835|O6|Outcome|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249758|NCT00094835|O5|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249759|NCT00094835|O4|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249760|NCT00094835|O3|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249761|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249762|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249933|NCT00094575|O1|Outcome|Endovascular Repair|
1249763|NCT00094835|O7|Outcome|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249764|NCT00094835|O6|Outcome|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249765|NCT00094835|O5|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249766|NCT00094835|O4|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249767|NCT00094835|O3|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249768|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249769|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249770|NCT00094835|E7|Reported Event|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249771|NCT00094835|E6|Reported Event|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249772|NCT00094835|E5|Reported Event|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249773|NCT00094835|E4|Reported Event|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249774|NCT00094835|E3|Reported Event|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249775|NCT00094835|E2|Reported Event|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1250312|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
1249776|NCT00094835|E1|Reported Event|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
1249777|NCT00094809|B3|Baseline|Total|Total of all reporting groups
1249778|NCT00094809|B2|Baseline|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
1249779|NCT00094809|B1|Baseline|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
1249780|NCT00094809|P2|Participant Flow|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
1249781|NCT00094809|P1|Participant Flow|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
1249782|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
1249783|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
1249784|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
1249785|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
1249786|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
1249787|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
1249788|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
1249789|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
1249792|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
1249793|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
1249794|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
1249795|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
1249796|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
1249797|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
1249798|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
1249799|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
1249800|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
1249801|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
1249802|NCT00094809|E2|Reported Event|Pegfilgrastim|
1249803|NCT00094809|E1|Reported Event|Placebo|
1249804|NCT00094770|B3|Baseline|Total|Total of all reporting groups
1249805|NCT00094770|B2|Baseline|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
1249806|NCT00094770|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
1249807|NCT00094770|P2|Participant Flow|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
1249808|NCT00094770|P1|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
1249809|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
1249810|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
1249811|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
1249812|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
1249813|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
1249814|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
1249815|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
1249816|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
1249817|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
1249818|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
1249819|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
1249820|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
1249821|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
1249822|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
1249823|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
1249824|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
1249825|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
1249826|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
1249827|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
1249828|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
1249829|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
1249830|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
1249831|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
1249832|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
1249833|NCT00094770|E2|Reported Event|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
1249834|NCT00094770|E1|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
1249835|NCT00094757|B4|Baseline|Total|Total of all reporting groups
1249836|NCT00094757|B3|Baseline|Placebo/Pioglitazone|The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
1249837|NCT00094757|B2|Baseline|Sitagliptin 200 mg|The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
1249838|NCT00094757|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
1249839|NCT00094757|P3|Participant Flow|Placebo/Pioglitazone|The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
1249840|NCT00094757|P2|Participant Flow|Sitagliptin 200 mg|The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
1249841|NCT00094757|P1|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
1249842|NCT00094757|O3|Outcome|Placebo/Pioglitazone|The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
1249843|NCT00094757|O2|Outcome|Sitagliptin 200 mg|The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
1249844|NCT00094757|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
1249845|NCT00094757|O3|Outcome|Placebo/Pioglitazone|The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
1249847|NCT00094757|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
1249848|NCT00094757|O3|Outcome|Placebo/Pioglitazone|The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
1249849|NCT00094757|O2|Outcome|Sitagliptin 200 mg|The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
1249850|NCT00094757|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
1249851|NCT00094757|O3|Outcome|Placebo/Pioglitazone|The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
1249852|NCT00094757|O2|Outcome|Sitagliptin 200 mg|The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
1249853|NCT00094757|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
1249854|NCT00094757|E3|Reported Event|Placebo/Pioglitazone|The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
1249855|NCT00094757|E2|Reported Event|Sitagliptin 200 mg|The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
1249856|NCT00094757|E1|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
1249857|NCT00094653|B4|Baseline|Total|Total of all reporting groups
1249858|NCT00094653|B3|Baseline|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249934|NCT00094575|O2|Outcome|Standard Open Repair|
1249935|NCT00094575|O1|Outcome|Endovascular Repair|
1249936|NCT00094575|O2|Outcome|Standard Open Repair|
1249859|NCT00094653|B2|Baseline|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249860|NCT00094653|B1|Baseline|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249861|NCT00094653|P3|Participant Flow|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249862|NCT00094653|P2|Participant Flow|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249863|NCT00094653|P1|Participant Flow|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249864|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249865|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249866|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1250018|NCT00094328|O1|Outcome|Open Label Bicalutamide With Anastrozole|Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently
1249867|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249868|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249869|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249870|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249871|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249937|NCT00094575|O1|Outcome|Endovascular Repair|
1249938|NCT00094575|O2|Outcome|Standard Open Repair|
1249939|NCT00094575|O1|Outcome|Endovascular Repair|
1249872|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249873|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249874|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249875|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249876|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249877|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249878|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249879|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249880|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249881|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249882|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249883|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249884|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249940|NCT00094575|O2|Outcome|Open Repair|Standard Open Repair
1249941|NCT00094575|O1|Outcome|Endovascular Repair|Endovascular Repair
1249942|NCT00094575|O2|Outcome|Open Repair|Standard Open Repair
1249885|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249886|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249887|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249888|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249889|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249890|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249891|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249892|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249893|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1250019|NCT00094328|O1|Outcome|Open Label Bicalutamide With Anastrozole|Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently
1249894|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249895|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249896|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249897|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249943|NCT00094575|O1|Outcome|Endovascular Repair|Endovascular Repair
1249944|NCT00094575|E2|Reported Event|Open Repair|Standard Open Repair
1249898|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249899|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249900|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249901|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249902|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249903|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249904|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249905|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249906|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249907|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249908|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249909|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249910|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249945|NCT00094575|E1|Reported Event|Endovascular Repair|Endovascular Repair
1249946|NCT00094536|B1|Baseline|Extended Treatment Regimen|Extended treatment regimens using the Her Option Endometrial Cryotherapy System.
1249947|NCT00094536|P1|Participant Flow|Extended Treatment Regimen|Extended treatment regimens using the Her Option Endometrial Cryotherapy System.
1250423|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
1249911|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249912|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249913|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249914|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249915|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249916|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249917|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249918|NCT00094653|O2|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249919|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249920|NCT00094653|E3|Reported Event|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1250313|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
1249921|NCT00094653|E2|Reported Event|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249922|NCT00094653|E1|Reported Event|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
1249923|NCT00094575|B3|Baseline|Total|Total of all reporting groups
1249924|NCT00094575|B2|Baseline|Open Repair|Standard Open Repair
1249925|NCT00094575|B1|Baseline|Endovascular Repair|Endovascular Repair
1249926|NCT00094575|P2|Participant Flow|Open Repair|Standard Open Repair
1249927|NCT00094575|P1|Participant Flow|Endovascular Repair|Endovascular Repair
1249928|NCT00094575|O2|Outcome|Standard Open Repair|
1249949|NCT00094536|E1|Reported Event|Extended Treatment Regimen|Extended treatment regimens using the Her Option Endometrial Cryotherapy System.
1249950|NCT00094497|B3|Baseline|Total|Total of all reporting groups
1249951|NCT00094497|B2|Baseline|Sz-M|"streptozotocin and mitotane~Streptozotocin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
1249952|NCT00094497|B1|Baseline|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane~Etoposide~Doxorubicin~Cisplatin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
1249953|NCT00094497|P2|Participant Flow|Sz-M|"streptozotocin and mitotane~Streptozotocin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
1249954|NCT00094497|P1|Participant Flow|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane~Etoposide~Doxorubicin~Cisplatin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
1249955|NCT00094497|O2|Outcome|Sz-M|"streptozotocin and mitotane~Streptozotocin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
1249956|NCT00094497|O1|Outcome|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane~Etoposide~Doxorubicin~Cisplatin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
1249957|NCT00094497|O2|Outcome|Sz-M|"streptozotocin and mitotane~Streptozotocin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
1249958|NCT00094497|O1|Outcome|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane~Etoposide~Doxorubicin~Cisplatin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
1249959|NCT00094497|O2|Outcome|Sz-M|"streptozotocin and mitotane~Streptozotocin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
1249960|NCT00094497|O1|Outcome|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane~Etoposide~Doxorubicin~Cisplatin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
1249961|NCT00094497|O2|Outcome|Sz-M|"streptozotocin and mitotane~Streptozotocin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
1249962|NCT00094497|O1|Outcome|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane~Etoposide~Doxorubicin~Cisplatin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
1249963|NCT00094497|O2|Outcome|Sz-M|"streptozotocin and mitotane~Streptozotocin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
1249964|NCT00094497|O1|Outcome|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane~Etoposide~Doxorubicin~Cisplatin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
1249965|NCT00094497|E2|Reported Event|Sz-M|"streptozotocin and mitotane~Streptozotocin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
1249966|NCT00094497|E1|Reported Event|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane~Etoposide~Doxorubicin~Cisplatin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
1249967|NCT00094458|B4|Baseline|Total|Total of all reporting groups
1249968|NCT00094458|B3|Baseline|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
1249969|NCT00094458|B2|Baseline|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
1249970|NCT00094458|B1|Baseline|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
1249971|NCT00094458|P6|Participant Flow|Infliximab + Azathioprine/Infliximab|Participants received daily AZA oral capsules 2.5mg/kg/day and IFX infusions 5mg/kg through Week 50. IFX infusions 5mg/kg in one year country specific (EU and Israel) Open-Label Extension.
1249972|NCT00094458|P5|Participant Flow|Infliximab + Placebo/Infliximab|Participants received Placebo oral capsules daily and IFX infusions 5mg/kg through Week 50. IFX infusions 5mg/kg in one year country specific (EU and Israel) Open-Label Extension.
1249973|NCT00094458|P4|Participant Flow|Azathioprine + Placebo/Infliximab|Participants received daily AZA oral capsules 2.5mg/kg/day and Placebo infusion through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (EU and Israel) open-Label Extension.
1249974|NCT00094458|P3|Participant Flow|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
1250032|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
1250033|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
1249975|NCT00094458|P2|Participant Flow|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
1249976|NCT00094458|P1|Participant Flow|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
1249977|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
1249978|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
1249979|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
1249980|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
1249981|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
1249982|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
1249983|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
1249984|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
1249985|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
1249986|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
1249987|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
1250067|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
1250269|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
1250424|NCT00092677|O2|Outcome|Placebo|
1249988|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
1249989|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
1249990|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
1249991|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
1249992|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
1249993|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
1249994|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
1249995|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
1250095|NCT00094107|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
1249996|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
1249997|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
1249998|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
1249999|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
1250000|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
1250001|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
1250002|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
1250003|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
1250004|NCT00094458|E9|Reported Event|OLE-Infliximab + Azathioprine/Infliximab|Azathioprine (AZA) oral capsules daily 2.5mg/kg/day and infliximab (IFX) infusions 5mg/kg through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (UE and Israel) Open-Label Extension.
1250005|NCT00094458|E8|Reported Event|OLE-Infliximab + Placebo/Infliximab|Placebo (PBO) oral capsules daily and infliximab (IFX) infusions 5mg/kg through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (UE and Israel) Open-Label Extension.
1250006|NCT00094458|E7|Reported Event|OLE-Azathioprine + Placebo/Infliximab|Azathioprine (AZA) oral capsules daily 2.5mg/kg/day and Placebo (PBO) infusion through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (UE and Israel) Open-Label Extension.
1250007|NCT00094458|E6|Reported Event|W50-Infliximab + Azathioprine|Azathioprine (AZA) oral capsules daily 2.5 mg/kg/day and Infliximab (IFX) infusions 5 mg/kg Week 30 through Week 50.
1250008|NCT00094458|E5|Reported Event|W50-Infliximab + Placebo|Placebo (PBO) oral capsules daily and Infliximab (IFX) infusions 5 mg/kg Week 30 through Week 50.
1250009|NCT00094458|E4|Reported Event|W50-Azathioprine + Placebo|(AZA) oral daily 2.5 mg/kg/day and Placebo (PBO) infusion Week 30 through Week 50.
1250010|NCT00094458|E3|Reported Event|W30-Infliximab + Azathioprine|Azathioprine (AZA) oral daily 2.5 mg/kg/day and Infliximab (IFX) infusions 5mg/kg through Week 30.
1250011|NCT00094458|E2|Reported Event|W30-Infliximab + Placebo|Placebo (PBO) oral daily and Infliximab (IFX) infusions 5 mg/kg through Week 30.
1250012|NCT00094458|E1|Reported Event|W30-Azathioprine + Placebo|Azathioprine (AZA) oral capsules 2.5 mg/kg/day and Placebo (PBO) infusion through Week 30.
1250013|NCT00094328|B1|Baseline|Open Label Bicalutamide With Anastrozole|Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently
1250014|NCT00094328|P1|Participant Flow|Open Label Bicalutamide With Anastrozole|Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently
1250015|NCT00094328|O1|Outcome|Open Label Bicalutamide With Anastrozole|Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently
1250016|NCT00094328|O1|Outcome|Open Label Bicalutamide With Anastrozole|Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently
1250017|NCT00094328|O1|Outcome|Open Label Bicalutamide With Anastrozole|Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently
1250020|NCT00094328|E1|Reported Event|Open Label Bicalutamide With Anastrozole|Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently
1250021|NCT00094302|B3|Baseline|Total|Total of all reporting groups
1250022|NCT00094302|B2|Baseline|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
1250023|NCT00094302|B1|Baseline|Placebo|Placebo of spironolactone
1250024|NCT00094302|P2|Participant Flow|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
1250025|NCT00094302|P1|Participant Flow|Placebo|Placebo of spironolactone
1250026|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
1250027|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
1250028|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
1250029|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
1250030|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
1250031|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
1250270|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
1250425|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
1250034|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
1250035|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
1250036|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
1250037|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
1250038|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
1250039|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
1250040|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
1250041|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
1250042|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
1250043|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
1250044|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
1250045|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
1250046|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
1250047|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
1250048|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
1250049|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
1250050|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
1250051|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
1250052|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
1250053|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
1250314|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
1250054|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
1250055|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
1250056|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
1250057|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
1250058|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
1250059|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
1250060|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
1250061|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
1250062|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
1250063|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
1250064|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
1250065|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
1250066|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
1250426|NCT00092677|O2|Outcome|Placebo|
1250068|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
1250069|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
1250070|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
1250071|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
1250072|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
1250073|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
1250074|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
1250075|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
1250076|NCT00094302|E2|Reported Event|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
1250077|NCT00094302|E1|Reported Event|Placebo|Placebo of spironolactone
1250078|NCT00094172|B3|Baseline|Total|Total of all reporting groups
1250079|NCT00094172|B2|Baseline|Placebo|Non-Active Comparator
1250080|NCT00094172|B1|Baseline|Atorvastatin|Drug: Atorvastatin
1250081|NCT00094172|P2|Participant Flow|Placebo|Non-Active Comparator
1250082|NCT00094172|P1|Participant Flow|Atorvastatin|Drug: Atorvastatin
1250083|NCT00094172|O2|Outcome|Placebo|Non-Active Comparator
1250084|NCT00094172|O1|Outcome|Atorvastatin|Drug: Atorvastatin
1250085|NCT00094172|O2|Outcome|Placebo|Non-Active Comparator
1250086|NCT00094172|O1|Outcome|Atorvastatin|Drug: Atorvastatin
1250087|NCT00094172|O2|Outcome|Placebo|Non-Active Comparator
1250088|NCT00094172|O1|Outcome|Atorvastatin|Drug: Atorvastatin
1250089|NCT00094172|E2|Reported Event|Placebo|Non-Active Comparator
1250090|NCT00094172|E1|Reported Event|Atorvastatin|Drug: Atorvastatin
1250091|NCT00094107|B1|Baseline|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
1250092|NCT00094107|P1|Participant Flow|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
1250093|NCT00094107|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
1250094|NCT00094107|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
1250315|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
1250096|NCT00094107|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
1250097|NCT00094107|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
1250098|NCT00094107|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
1250099|NCT00094107|E1|Reported Event|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
1250100|NCT00094094|B1|Baseline|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
1250101|NCT00094094|P1|Participant Flow|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
1250102|NCT00094094|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
1250103|NCT00094094|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
1250104|NCT00094094|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
1250105|NCT00094094|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
1250106|NCT00094094|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
1250271|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
1250107|NCT00094094|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
1250108|NCT00094094|E1|Reported Event|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
1250109|NCT00094055|B1|Baseline|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
1250110|NCT00094055|P1|Participant Flow|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
1250111|NCT00094055|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
1250112|NCT00094055|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
1250113|NCT00094055|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
1250114|NCT00094055|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
1250115|NCT00094055|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
1250116|NCT00094055|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
1250117|NCT00094055|E1|Reported Event|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
1250118|NCT00093847|B3|Baseline|Total|Total of all reporting groups
1250119|NCT00093847|B2|Baseline|Oral Adjunct Placebo|Participants receiving placebo
1250120|NCT00093847|B1|Baseline|Adjunct Oral SAMe Tosylate 800mg PO BiD|Participants receiving the oral SAMe tosylate
1250121|NCT00093847|P2|Participant Flow|Oral Adjunct Placebo|Participants receiving placebo
1250122|NCT00093847|P1|Participant Flow|Adjunct Oral SAMe Tosylate 800mg PO BiD|Participants receiving the oral SAMe tosylate
1250123|NCT00093847|O2|Outcome|Oral Adjunct Placebo|Participants receiving placebo
1250124|NCT00093847|O1|Outcome|Adjunct Oral SAMe Tosylate 800mg PO BiD|Participants receiving the oral SAMe tosylate
1250125|NCT00093847|O2|Outcome|Oral Adjunct Placebo|Participants receiving placebo
1250126|NCT00093847|O1|Outcome|Adjunct Oral SAMe Tosylate 800mg PO BiD|Participants receiving the oral SAMe tosylate
1250127|NCT00093847|E2|Reported Event|Oral Adjunct Placebo|Participants receiving placebo
1250128|NCT00093847|E1|Reported Event|Adjunct Oral SAMe Tosylate 800mg PO BiD|Participants receiving the oral SAMe tosylate
1250148|NCT00093756|B1|Baseline|PhaseI|PHASE I: Cohorts of 3-6 patients receive escalating doses of study medications until the maximum tolerated dose (MTD) is determined. 3-dimensional conformal radiation therapy > bortezomib: Given IV > paclitaxel: Given IV > carboplatin: Given IV
1250129|NCT00093808|B1|Baseline|Capecitabine + Vinorelbine + Trastuzumab|Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
1250130|NCT00093808|P1|Participant Flow|Capecitabine + Vinorelbine + Trastuzumab|Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
1250131|NCT00093808|O1|Outcome|Capecitabine + Vinorelbine + Trastuzumab|Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
1250132|NCT00093808|O1|Outcome|Capecitabine + Vinorelbine + Trastuzumab|Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
1250133|NCT00093808|O1|Outcome|Capecitabine + Vinorelbine + Trastuzumab|Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
1250134|NCT00093808|O1|Outcome|Capecitabine + Vinorelbine + Trastuzumab|Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
1250272|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
1250135|NCT00093808|E1|Reported Event|Capecitabine + Vinorelbine + Trastuzumab|Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
1250136|NCT00093782|B1|Baseline|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
1250137|NCT00093782|P1|Participant Flow|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
1250138|NCT00093782|O1|Outcome|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
1250139|NCT00093782|O1|Outcome|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
1250140|NCT00093782|O1|Outcome|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
1250141|NCT00093782|O1|Outcome|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
1250142|NCT00093782|O1|Outcome|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
1250143|NCT00093782|O1|Outcome|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
1250144|NCT00093782|O1|Outcome|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
1250145|NCT00093782|E1|Reported Event|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
1250146|NCT00093756|B3|Baseline|Total|Total of all reporting groups
1250147|NCT00093756|B2|Baseline|PhaseII|PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy > bortezomib: Given IV > paclitaxel: Given IV > carboplatin: Given IV
1250149|NCT00093756|P2|Participant Flow|PhaseII|PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, , carboplatin: Given IV.
1250150|NCT00093756|P1|Participant Flow|PhaseI|PHASE I: Cohorts of 3-6 patients receive escalating doses of study medications until the maximum tolerated dose (MTD) is determined. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, carboplatin: Given IV.
1250151|NCT00093756|O1|Outcome|PhaseII|PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, carboplatin: Given IV.
1250152|NCT00093756|E2|Reported Event|PhaseII|PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, carboplatin: Given IV.
1250153|NCT00093756|E1|Reported Event|PhaseI|PHASE I: Cohorts of 3-6 patients receive escalating doses of study medications until the maximum tolerated dose (MTD) is determined. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, carboplatin: Given IV.
1250154|NCT00093496|B3|Baseline|Total|Total of all reporting groups
1250155|NCT00093496|B2|Baseline|Cohort 2 (Prior Gemcitabine Exposure)|Patients with prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
1250156|NCT00093496|B1|Baseline|Cohort 1 (No Prior Gemcitabine Exposure)|Patients with no prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
1250273|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
1250157|NCT00093496|P2|Participant Flow|Cohort 2 (Prior Gemcitabine Exposure)|Patients with prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
1250158|NCT00093496|P1|Participant Flow|Cohort 1 (No Prior Gemcitabine Exposure)|Patients with no prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
1250159|NCT00093496|O2|Outcome|Cohort 2 (Prior Gemcitabine Exposure)|Patients with prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
1250160|NCT00093496|O1|Outcome|Cohort 1 (No Prior Gemcitabine Exposure)|Patients with no prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
1250161|NCT00093496|O2|Outcome|Cohort 2 (Prior Gemcitabine Exposure)|Patients with prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
1250162|NCT00093496|O1|Outcome|Cohort 1 (No Prior Gemcitabine Exposure)|Patients with no prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
1250163|NCT00093496|O2|Outcome|Cohort 2 (Prior Gemcitabine Exposure)|Patients with prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
1250164|NCT00093496|O1|Outcome|Cohort 1 (No Prior Gemcitabine Exposure)|Patients with no prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
1250165|NCT00093496|O2|Outcome|Cohort 2 (Prior Gemcitabine Exposure)|Patients with prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
1250224|NCT00093041|E1|Reported Event|Zalutumumab 0.15 mg/kg|
1250225|NCT00093015|B3|Baseline|Total|Total of all reporting groups
1250166|NCT00093496|O1|Outcome|Cohort 1 (No Prior Gemcitabine Exposure)|Patients with no prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
1250167|NCT00093496|E1|Reported Event|All Patients Receiving Gemcitabine|All patients receiving gemcitabine were combined to analyze toxicity.
1250168|NCT00093470|B3|Baseline|Total|Total of all reporting groups
1250169|NCT00093470|B2|Baseline|Arm B (Clinical Observation)|"Patients undergo observation only.~Clinical Observation: Undergo observation"
1250170|NCT00093470|B1|Baseline|Arm A (Tipifarnib)|"Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Tipifarnib: Given PO"
1250171|NCT00093470|P2|Participant Flow|Arm B (Clinical Observation)|"Patients undergo observation only.~Clinical Observation: Undergo observation"
1250172|NCT00093470|P1|Participant Flow|Arm A (Tipifarnib)|"Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Tipifarnib: Given PO"
1250173|NCT00093470|O2|Outcome|Arm B (Clinical Observation)|Patients undergo observation only.
1250174|NCT00093470|O1|Outcome|Arm A (Tipifarnib)|Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1250175|NCT00093470|O2|Outcome|Arm B (Clinical Observation)|Patients undergo observation only.
1250176|NCT00093470|O1|Outcome|Arm A (Tipifarnib)|Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1250177|NCT00093470|E2|Reported Event|Arm B (Clinical Observation)|Patients undergo observation only.
1250178|NCT00093470|E1|Reported Event|Arm A (Tipifarnib)|Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1250179|NCT00093379|B1|Baseline|Capecitabine + Oxaliplatin + XRT|Capecitabine (825 mg/m^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
1250180|NCT00093379|P1|Participant Flow|Capecitabine + Oxaliplatin + XRT|Capecitabine (825 mg/m^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy (XRT) once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor.
1250181|NCT00093379|O1|Outcome|Capecitabine + Oxaliplatin + XRT|Capecitabine (825 mg/m^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
1250182|NCT00093379|O1|Outcome|Capecitabine + Oxaliplatin + XRT|Capecitabine (825 mg/m^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
1250183|NCT00093379|O1|Outcome|Capecitabine + Oxaliplatin + XRT|Capecitabine (825 mg/m^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
1250184|NCT00093379|E1|Reported Event|Capecitabine + Oxaliplatin + XRT|Capecitabine (825 mg/m^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
1250185|NCT00093145|B1|Baseline|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
1250186|NCT00093145|P1|Participant Flow|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
1250226|NCT00093015|B2|Baseline|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
1250316|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
1250187|NCT00093145|O1|Outcome|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
1250188|NCT00093145|O1|Outcome|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
1250189|NCT00093145|O1|Outcome|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
1250234|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
1250393|NCT00091793|P2|Participant Flow|Placebo|
1250190|NCT00093145|O1|Outcome|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
1250191|NCT00093145|O1|Outcome|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
1250192|NCT00093145|O1|Outcome|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
1250193|NCT00093145|E1|Reported Event|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
1250194|NCT00093041|B7|Baseline|Total|Total of all reporting groups
1250195|NCT00093041|B6|Baseline|Zalutumumab 8 mg/kg|
1250196|NCT00093041|B5|Baseline|Zalutumumab 4 mg/kg|
1250197|NCT00093041|B4|Baseline|Zalutumumab 2 mg/kg|
1250198|NCT00093041|B3|Baseline|Zalutumumab 1 mg/kg|
1250199|NCT00093041|B2|Baseline|Zalutumumab 0.5 mg/kg|
1250200|NCT00093041|B1|Baseline|Zalutumumab 0.15 mg/kg|
1250201|NCT00093041|P6|Participant Flow|Zalutumumab 8 mg/kg|
1250202|NCT00093041|P5|Participant Flow|Zalutumumab 4 mg/kg|
1250203|NCT00093041|P4|Participant Flow|Zalutumumab 2 mg/kg|
1250204|NCT00093041|P3|Participant Flow|Zalutumumab 1 mg/kg|
1250205|NCT00093041|P2|Participant Flow|Zalutumumab 0.5 mg/kg|
1250206|NCT00093041|P1|Participant Flow|Zalutumumab 0.15 mg/kg|
1250207|NCT00093041|O6|Outcome|Zalutumumab 8 mg/kg|
1250208|NCT00093041|O5|Outcome|Zalutumumab 4 mg/kg|
1250209|NCT00093041|O4|Outcome|Zalutumumab 2 mg/kg|
1250210|NCT00093041|O3|Outcome|Zalutumumab 1 mg/kg|
1250211|NCT00093041|O2|Outcome|Zalutumumab 0.5 mg/kg|
1250212|NCT00093041|O1|Outcome|Zalatumumab 0.15 mg/kg|
1250213|NCT00093041|O6|Outcome|Zalutumumab 8 mg/kg|
1250214|NCT00093041|O5|Outcome|Zalutumumab 4 mg/kg|
1250215|NCT00093041|O4|Outcome|Zalutumumab 2 mg/kg|
1250216|NCT00093041|O3|Outcome|Zalutumumab 1 mg/kg|
1250217|NCT00093041|O2|Outcome|Zalutumumab 0.5 mg/kg|
1250218|NCT00093041|O1|Outcome|Zalatumumab 0.15 mg/kg|
1250219|NCT00093041|E6|Reported Event|Zalutumumab 8 mg/kg|
1250220|NCT00093041|E5|Reported Event|Zalutumumab 4 mg/kg|
1250221|NCT00093041|E4|Reported Event|Zalutumumab 2 mg/kg|
1250222|NCT00093041|E3|Reported Event|Zalutumumab 1 mg/kg|
1250223|NCT00093041|E2|Reported Event|Zalutumumab 0.5 mg/kg|
1250227|NCT00093015|B1|Baseline|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
1250228|NCT00093015|P2|Participant Flow|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
1250229|NCT00093015|P1|Participant Flow|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
1250230|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
1250231|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
1250232|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
1250233|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
1250235|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
1250236|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
1250237|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
1250238|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
1250239|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
1250240|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
1250241|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
1250242|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
1250243|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
1250244|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
1250245|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
1250246|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
1250247|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
1250248|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
1250249|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
1250305|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
1250306|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
1250250|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
1250251|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
1250252|NCT00093015|E2|Reported Event|Darbepoetin Alfa|
1250253|NCT00093015|E1|Reported Event|Placebo|
1250254|NCT00091832|B7|Baseline|Total|Total of all reporting groups
1250255|NCT00091832|B6|Baseline|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
1250256|NCT00091832|B5|Baseline|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
1250257|NCT00091832|B4|Baseline|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
1250258|NCT00091832|B3|Baseline|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
1250259|NCT00091832|B2|Baseline|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
1250260|NCT00091832|B1|Baseline|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
1250261|NCT00091832|P6|Participant Flow|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
1250262|NCT00091832|P5|Participant Flow|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
1250263|NCT00091832|P4|Participant Flow|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
1250264|NCT00091832|P3|Participant Flow|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
1250265|NCT00091832|P2|Participant Flow|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
1250266|NCT00091832|P1|Participant Flow|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion (IV)
1250274|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
1250275|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
1250276|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
1250277|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
1250278|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
1250279|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
1250280|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
1250281|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
1250282|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
1250283|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
1250284|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
1250285|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
1250286|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
1250287|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
1250288|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
1250289|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
1250290|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
1250291|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
1250292|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
1250293|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
1250294|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
1250295|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
1250296|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
1250297|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
1250298|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
1250299|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
1250300|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
1250301|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
1250302|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
1250303|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
1250304|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
1250317|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
1250318|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
1250319|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
1250320|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
1250321|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
1250322|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
1250323|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
1250324|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
1250325|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
1250326|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
1250327|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
1250328|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
1250329|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
1250330|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
1250331|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
1250332|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
1250333|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
1250334|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
1250335|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
1250336|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
1250337|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
1250338|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
1250339|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
1250340|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
1250341|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
1250342|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
1250343|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
1250344|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
1250345|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
1250346|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
1250347|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
1250348|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
1250349|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
1250350|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
1250351|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
1250352|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
1250353|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
1250354|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
1250355|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
1250356|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
1250357|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
1250358|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
1250359|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
1250360|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
1250361|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
1250362|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
1250363|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
1250364|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
1250365|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
1250366|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
1250367|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
1250368|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
1250369|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
1250370|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
1250371|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
1250372|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
1250373|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
1250374|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
1250375|NCT00091832|E6|Reported Event|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
1250376|NCT00091832|E5|Reported Event|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
1250377|NCT00091832|E4|Reported Event|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
1250378|NCT00091832|E3|Reported Event|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
1250379|NCT00091832|E2|Reported Event|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
1250380|NCT00091832|E1|Reported Event|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion.
1250381|NCT00091819|B3|Baseline|Total|Total of all reporting groups
1250382|NCT00091819|B2|Baseline|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gram every 12 hours. The maximum allowable treatment period was 14 days.
1250383|NCT00091819|B1|Baseline|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
1250384|NCT00091819|P2|Participant Flow|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gram every 12 hours. The maximum allowable treatment period was 14 days.
1250385|NCT00091819|P1|Participant Flow|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
1250386|NCT00091819|O2|Outcome|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gram every 12 hours. The maximum allowable treatment period was 14 days.
1250387|NCT00091819|O1|Outcome|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
1250388|NCT00091819|E2|Reported Event|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gram every 12 hours. The maximum allowable treatment period was 14 days.
1250389|NCT00091819|E1|Reported Event|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
1250390|NCT00091793|B3|Baseline|Total|Total of all reporting groups
1250391|NCT00091793|B2|Baseline|Placebo|
1250392|NCT00091793|B1|Baseline|Denosumab 60 mg Q6M|
1250427|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
1250428|NCT00092677|O2|Outcome|Placebo|
1250429|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
1250430|NCT00092677|O2|Outcome|Placebo|
1250431|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
1250432|NCT00092677|O2|Outcome|Placebo|
1250433|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
1250434|NCT00092677|O2|Outcome|Placebo|
1250435|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
1250436|NCT00092677|O2|Outcome|Placebo|
1250437|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
1250438|NCT00092677|O2|Outcome|Placebo|
1250439|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
1250440|NCT00092677|O2|Outcome|Placebo|
1250441|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
1250442|NCT00092677|O2|Outcome|Placebo|
1250443|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
1250444|NCT00092677|O2|Outcome|Placebo|
1250453|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
1250454|NCT00092677|O2|Outcome|Placebo|
1250455|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
1250456|NCT00092677|O2|Outcome|Placebo|
1250457|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
1250458|NCT00092677|E2|Reported Event|Placebo|
1250459|NCT00092677|E1|Reported Event|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
1250460|NCT00092547|B3|Baseline|Total|Total of all reporting groups
1250461|NCT00092547|B2|Baseline|Placebo in Base Study|Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
1250462|NCT00092547|B1|Baseline|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
1250463|NCT00092547|P3|Participant Flow|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
1250464|NCT00092547|P2|Participant Flow|Placebo in Base Study|Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6.
1250465|NCT00092547|P1|Participant Flow|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6.
1250466|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
1250467|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
1250468|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
1250469|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
1250470|NCT00092547|O1|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
1250471|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
1250472|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
1250473|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represent participants randomized to the qHPV vaccine group
1250474|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
1250475|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
1250476|NCT00092547|O1|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
1250477|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
1250478|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
1250479|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
1250480|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
1250481|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
1250482|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
1250483|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
1250484|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
1250485|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
1250486|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
1250487|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
1250488|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
1250774|NCT00091949|O1|Outcome|Pioglitazone|pioglitazone: a thiazolidinedione drug
1250489|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
1250490|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
1250491|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
1250492|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
1250493|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
1250494|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
1250495|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
1250496|NCT00092547|O2|Outcome|Placebo in Base Study|Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
1250497|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
1250498|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
1250499|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
1250500|NCT00092547|O2|Outcome|Placebo in Base Study|Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
1250501|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
1250502|NCT00092547|E4|Reported Event|qHPV Vaccine in Extension: Extension and Long-term Follow-up|Participants who received placebo in the Base Study and three 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36 in the Extension Study. Adverse events are reported for this group from Month 30 to Month 126. Non-serious AEs were not solicited.
1250503|NCT00092547|E3|Reported Event|qHPV Vaccine in Base: Extension and Long-term Follow-up|Participants who received qHPV in the Base Study. No study treatment was administered after Month 6 for these participants. Adverse events are reported for this group from Month 30 to Month 126. Non-serious AEs were not solicited.
1250504|NCT00092547|E2|Reported Event|Placebo in Base: Vaccine Phase and Follow-up|"Participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo vaccine at Day 1, Month 2, and Month 6, and had safety followup.~Adverse events are reported for this group from Day 1 to Month 30."
1250505|NCT00092547|E1|Reported Event|qHPV Vaccine in Base: Vaccine Phase and Follow-up|Participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of qHPV at Day 1, Month 2, and Month 6, and had safety follow-up. Adverse events are reported for this group from Day 1 to Month 30.
1250506|NCT00092534|B3|Baseline|Total|Total of all reporting groups
1250507|NCT00092534|B2|Baseline|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
1250508|NCT00092534|B1|Baseline|Quadrivalent Human Papillomavirus Vaccine (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
1250523|NCT00092534|E2|Reported Event|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
1250509|NCT00092534|P3|Participant Flow|Extension Study|"This group includes 581 subjects who received placebo during the base study, (Group 2-Base Study) and 13 additional subjects who were randomized to the active vaccine arm of the base study (from Group 1-Base Study), but received fewer than the full three doses of Quadrivalent HPV vaccine during the base study. Subjects designated as Completed Period are those who received three doses of Quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as Not Completed are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up."
1250510|NCT00092534|P2|Participant Flow|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
1250511|NCT00092534|P1|Participant Flow|Quadrivalent Human Papillomavirus Vaccine (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
1250542|NCT00092495|B4|Baseline|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
1250543|NCT00092495|B3|Baseline|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
1250512|NCT00092534|O2|Outcome|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
1250513|NCT00092534|O1|Outcome|Quadrivalent Human Papillomavirus Vaccine (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
1250514|NCT00092534|O2|Outcome|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
1250515|NCT00092534|O1|Outcome|Quadrivalent Human Papillomavirus Vaccine (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
1250516|NCT00092534|O2|Outcome|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
1250517|NCT00092534|O1|Outcome|Quadrivalent Human Papillomavirus Vaccine (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
1250518|NCT00092534|O2|Outcome|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
1250519|NCT00092534|O1|Outcome|Quadrivalent Human Papillomavirus Vaccine (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
1250520|NCT00092534|O2|Outcome|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
1250521|NCT00092534|O1|Outcome|Quadrivalent Human Papillomavirus Vaccine (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
1250522|NCT00092534|E3|Reported Event|Extension Study|"This group includes 581 subjects who received placebo during the base study, (Group 2-Base Study) and 13 additional subjects who were randomized to the active vaccine arm of the base study (from Group 1-Base Study), but received fewer than the full three doses of Quadrivalent HPV vaccine during the base study. Subjects designated as Completed Period are those who received three doses of Quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as Not Completed are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up.~Extension study includes subjects from Group 2-Base Study who were vaccinated with quadrivalent HPV vaccine.~No data on non-serious adverse events were collected on this group during the extension study, hence no data are entered for them in the table."
1250524|NCT00092534|E1|Reported Event|Quadrivalent Human Papillomavirus Vaccine (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
1250525|NCT00092521|B4|Baseline|Total|Total of all reporting groups
1250526|NCT00092521|B3|Baseline|Group 3 - Base Study Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
1250527|NCT00092521|B2|Baseline|Group 2 - Base Study Monovalent HPV (Type 16) Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with the Monovalent (HPV 16) HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
1250587|NCT00092495|O3|Outcome|Women 16-23 Years|
1250528|NCT00092521|B1|Baseline|Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
1250529|NCT00092521|P4|Participant Flow|Group 4 - Quadrivalent Human Papillomavirus Vaccine Extension|"This group includes subjects who entered the extension including subjects who in the base study received fewer than the full three doses of Quadrivalent HPV vaccine during the base study (i.e., subjects who received placebo in the base study; subjects who received monovalent [type 16] HPV vaccine in the base study, or subjects who received <=2 doses of quadrivalent HPV vaccine in the base study). Subjects who discontinued the base portion of the study could enter the extension portion of the study. In the extension period subjects designated as Completed Period are those who received three doses of quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as Not Completed are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up."
1250530|NCT00092521|P3|Participant Flow|Group 3 - Base Study Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
1250531|NCT00092521|P2|Participant Flow|Group 2 - Base Study Monovalent HPV (Type 16) Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with the Monovalent (HPV 16) HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.~Group 2 Base Study Monovalent HPV (Type 16) Vaccine was not part of the pre-specified efficacy analysis population."
1250532|NCT00092521|P1|Participant Flow|Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent Human papillomavirus (HPV) vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
1250533|NCT00092521|O2|Outcome|Group 3 - Base Study Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
1250534|NCT00092521|O1|Outcome|Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
1250535|NCT00092521|O2|Outcome|Group 3 - Base Study Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
1250536|NCT00092521|O1|Outcome|Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
1250537|NCT00092521|E4|Reported Event|Group 4 - Quadrivalent Human Papillomavirus Vaccine Extension|"This group includes subjects who entered the extension including subjects who in the base study received fewer than the full three doses of Quadrivalent HPV vaccine during the base study (i.e., subjects who received placebo in the base study; subjects who received monovalent [type 16] HPV vaccine in the base study, or subjects who received <=2 doses of quadrivalent HPV vaccine in the base study). Subjects who discontinued the base portion of the study could enter the extension portion of the study. In the extension period subjects designated as Completed Period are those who received three doses of quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as Not Completed are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up."
1250538|NCT00092521|E3|Reported Event|Group 3 - Base Study Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
1250539|NCT00092521|E2|Reported Event|Group 2 - Base Study Monovalent HPV (Type 16) Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with the Monovalent (HPV 16) HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
1250540|NCT00092521|E1|Reported Event|Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
1250541|NCT00092495|B5|Baseline|Total|Total of all reporting groups
1250588|NCT00092495|O2|Outcome|Boys 10-15 Years|
1250544|NCT00092495|B2|Baseline|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
1250545|NCT00092495|B1|Baseline|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
1250546|NCT00092495|P5|Participant Flow|Extension Study|"Extension Study: This group includes 12 subjects who participated in the base study and received either a partial dose formulation of the quadrivalent HPV vaccine in the base study and did not meet the protocol specified criteria for seroconversion, or subjects who, due to pregnancy, received 1 or 2 doses of the quadrivalent HPV vaccine in the base study and remained in the study through Month 7. The Extension Period began after all patients had completed the Month 7 follow-up period. Subjects designated as Completed Period are those who at the end of the study had received three injections of quadrivalent HPV vaccine and completed all follow-up visits. Subjects designated as Not Completed are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up."
1250547|NCT00092495|P4|Participant Flow|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
1250548|NCT00092495|P3|Participant Flow|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
1250549|NCT00092495|P2|Participant Flow|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
1250550|NCT00092495|P1|Participant Flow|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
1250551|NCT00092495|O4|Outcome|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
1250552|NCT00092495|O3|Outcome|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
1250553|NCT00092495|O2|Outcome|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
1250554|NCT00092495|O1|Outcome|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
1250555|NCT00092495|O4|Outcome|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
1250556|NCT00092495|O3|Outcome|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
1250557|NCT00092495|O2|Outcome|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
1250558|NCT00092495|O1|Outcome|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
1250559|NCT00092495|O3|Outcome|Women 16-23 Years|
1250560|NCT00092495|O2|Outcome|Boys 10-15 Years|
1250561|NCT00092495|O1|Outcome|Girls 10-15 Years|
1250562|NCT00092495|O3|Outcome|Women 16-23 Years|
1250563|NCT00092495|O2|Outcome|Boys 10-15 Years|
1250564|NCT00092495|O1|Outcome|Girls 10-15 Years|
1250565|NCT00092495|O4|Outcome|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
1250566|NCT00092495|O3|Outcome|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
1250567|NCT00092495|O2|Outcome|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
1250568|NCT00092495|O1|Outcome|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
1250569|NCT00092495|O4|Outcome|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
1250570|NCT00092495|O3|Outcome|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
1250571|NCT00092495|O2|Outcome|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
1250572|NCT00092495|O1|Outcome|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
1250573|NCT00092495|O3|Outcome|Women 16-23 Years|
1250574|NCT00092495|O2|Outcome|Boys 10-15 Years|
1250575|NCT00092495|O1|Outcome|Girls 10-15 Years|
1250576|NCT00092495|O3|Outcome|Women 16-23 Years|
1250577|NCT00092495|O2|Outcome|Boys 10-15 Years|
1250579|NCT00092495|O4|Outcome|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
1250580|NCT00092495|O3|Outcome|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
1250581|NCT00092495|O2|Outcome|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
1250582|NCT00092495|O1|Outcome|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
1250583|NCT00092495|O4|Outcome|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
1250584|NCT00092495|O3|Outcome|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
1250585|NCT00092495|O2|Outcome|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
1250586|NCT00092495|O1|Outcome|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
1250593|NCT00092495|O4|Outcome|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
1250594|NCT00092495|O3|Outcome|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
1250595|NCT00092495|O2|Outcome|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
1250596|NCT00092495|O1|Outcome|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
1250597|NCT00092495|O4|Outcome|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
1250598|NCT00092495|O3|Outcome|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
1250599|NCT00092495|O2|Outcome|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
1250600|NCT00092495|O1|Outcome|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
1250601|NCT00092495|O3|Outcome|Women 16-23 Years|
1250602|NCT00092495|O2|Outcome|Boys 10-15 Years|
1250603|NCT00092495|O1|Outcome|Girls 10-15 Years|
1250604|NCT00092495|O3|Outcome|Women 16-23 Years|
1250605|NCT00092495|O2|Outcome|Boys 10-15 Years|
1250606|NCT00092495|O1|Outcome|Girls 10-15 Years|
1250607|NCT00092495|E4|Reported Event|100% Formulation|Subjects in this group received a 100% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
1250608|NCT00092495|E3|Reported Event|60% Formulation|Subjects in this group received a 60% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
1250609|NCT00092495|E2|Reported Event|40% Formulation|Subjects in this group received a 40% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
1250610|NCT00092495|E1|Reported Event|20% Formulation|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
1250611|NCT00092456|B5|Baseline|Total|Total of all reporting groups
1250612|NCT00092456|B4|Baseline|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250613|NCT00092456|B3|Baseline|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250614|NCT00092456|B2|Baseline|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250615|NCT00092456|B1|Baseline|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250616|NCT00092456|P4|Participant Flow|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination
1250617|NCT00092456|P3|Participant Flow|RotaTeq™ Lot 3|Three oral doses (~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250618|NCT00092456|P2|Participant Flow|RotaTeq™ Lot 2|Three oral doses (~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250619|NCT00092456|P1|Participant Flow|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250620|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250621|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250622|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250623|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250624|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250625|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250626|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250627|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250775|NCT00091949|O2|Outcome|Placebo|placebo: an inactive substance
1250628|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250629|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250630|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250631|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250632|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250633|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250634|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250635|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250636|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250637|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250638|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250639|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250640|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250641|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250642|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250643|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250644|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250645|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250646|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250647|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250648|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250718|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
1250649|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250650|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250651|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250652|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250653|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250776|NCT00091949|O1|Outcome|Pioglitazone|pioglitazone: a thiazolidinedione drug
1250777|NCT00091949|O2|Outcome|Placebo|placebo: an inactive substance
1250654|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250655|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250656|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250657|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250658|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250659|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250660|NCT00092456|E4|Reported Event|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250661|NCT00092456|E3|Reported Event|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250662|NCT00092456|E2|Reported Event|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250663|NCT00092456|E1|Reported Event|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
1250664|NCT00092443|B3|Baseline|Total|Total of all reporting groups
1250665|NCT00092443|B2|Baseline|Placebo Matching RotaTeq™|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
1250666|NCT00092443|B1|Baseline|RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose)|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination, and followup for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
1250667|NCT00092443|P2|Participant Flow|Placebo Matching RotaTeq™|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
1250668|NCT00092443|P1|Participant Flow|RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose)|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination, and followup for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
1250669|NCT00092443|O10|Outcome|Placebo Matching RotaTeq™ (SNA - P1A)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
1250670|NCT00092443|O9|Outcome|Placebo Matching RotaTeq™ (SNA - G4)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
1250671|NCT00092443|O8|Outcome|Placebo Matching RotaTeq™ (SNA - G3)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
1250672|NCT00092443|O7|Outcome|Placebo Matching RotaTeq™ (SNA - G2)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
1250673|NCT00092443|O6|Outcome|Placebo Matching RotaTeq™ (SNA - G1)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
1250674|NCT00092443|O5|Outcome|RotaTeq™ at Expiry Potency (SNA - P1A)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
1250675|NCT00092443|O4|Outcome|RotaTeq™ at Expiry Potency (SNA - G4)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
1250676|NCT00092443|O3|Outcome|RotaTeq™ at Expiry Potency (SNA - G3)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
1250677|NCT00092443|O2|Outcome|RotaTeq™ at Expiry Potency (SNA - G2)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
1250678|NCT00092443|O1|Outcome|RotaTeq™ at Expiry Potency (SNA - G1)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
1250679|NCT00092443|O2|Outcome|Placebo Matching RotaTeq™|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination and follow-up for AGEs through the first rotavirus season post vaccination.
1250680|NCT00092443|O1|Outcome|RotaTeq™ at Expiry Potency (≈1.1 x 107 IU/Dose)|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
1250681|NCT00092443|E2|Reported Event|Placebo Matching RotaTeq™|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination and follow-up for AGEs through the first rotavirus season post vaccination.
1250682|NCT00092443|E1|Reported Event|RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose)|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
1250683|NCT00092417|B3|Baseline|Total|Total of all reporting groups
1250684|NCT00092417|B2|Baseline|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
1250685|NCT00092417|B1|Baseline|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
1250686|NCT00092417|P2|Participant Flow|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
1250687|NCT00092417|P1|Participant Flow|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
1250688|NCT00092417|O2|Outcome|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
1250689|NCT00092417|O1|Outcome|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
1250690|NCT00092417|O2|Outcome|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
1250691|NCT00092417|O1|Outcome|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
1250692|NCT00092417|O2|Outcome|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
1250693|NCT00092417|O1|Outcome|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
1250694|NCT00092417|O2|Outcome|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
1250695|NCT00092417|O1|Outcome|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
1250696|NCT00092417|O2|Outcome|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
1250697|NCT00092417|O1|Outcome|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
1250698|NCT00092417|E2|Reported Event|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
1250699|NCT00092417|E1|Reported Event|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
1250700|NCT00092131|B1|Baseline|Overall Study Population|All randomized patients
1250701|NCT00092131|P2|Participant Flow|Placebo in Period I Then Montelukast 10 mg in Period II|A montelukast matching-image placebo tablet (Treatment Period I) was taken orally as a single witnessed dose followed by a 3-7 day washout. Then a montelukast 10-mg tablet (Treatment Period II) was taken orally as a single witnessed dose.
1250702|NCT00092131|P1|Participant Flow|Montelukast 10 mg in Period I Then Placebo in Period II|A montelukast 10-mg tablet (Treatment Period I) was taken orally as a single witnessed dose followed by a 3-7 day washout. Then a montelukast matching-image placebo tablet (Treatment Period II) was taken orally as a single witnessed dose.
1250703|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
1250704|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
1250705|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
1250706|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
1250707|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
1250708|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
1250709|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
1250710|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
1250711|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
1250712|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
1250713|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
1250714|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
1250715|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
1250716|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
1250717|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
1250719|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
1250720|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
1250721|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
1250722|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
1250723|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
1250724|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
1250725|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
1250726|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
1250727|NCT00092131|E2|Reported Event|Placebo in Period I Then Montelukast 10 mg in Period II|A montelukast matching-image placebo tablet (Treatment Period I) was taken orally as a single witnessed dose followed by a 3-7 day washout. Then a montelukast 10-mg tablet (Treatment Period II) was taken orally as a single witnessed dose.
1250778|NCT00091949|O1|Outcome|Pioglitazone|pioglitazone: a thiazolidinedione drug
1250779|NCT00091949|O2|Outcome|Placebo|placebo: an inactive substance
1250728|NCT00092131|E1|Reported Event|Montelukast 10 mg in Period I Then Placebo in Period II|A montelukast 10-mg tablet (Treatment Period I) was taken orally as a single witnessed dose followed by a 3-7 day washout. Then a montelukast matching-image placebo tablet (Treatment Period II) was taken orally as a single witnessed dose.
1250729|NCT00092118|B3|Baseline|Total|Total of all reporting groups
1250730|NCT00092118|B2|Baseline|Montelukast 10 mg|Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
1250731|NCT00092118|B1|Baseline|Placebo|Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
1250732|NCT00092118|P2|Participant Flow|Montelukast 10 mg|Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
1250733|NCT00092118|P1|Participant Flow|Placebo|Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
1250734|NCT00092118|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
1250735|NCT00092118|O1|Outcome|Placebo|Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
1250736|NCT00092118|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
1250737|NCT00092118|O1|Outcome|Placebo|Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
1250738|NCT00092118|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
1250739|NCT00092118|O1|Outcome|Placebo|Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
1250740|NCT00092118|E2|Reported Event|Montelukast 10 mg|Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
1250741|NCT00092118|E1|Reported Event|Placebo|Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
1250742|NCT00091962|B4|Baseline|Total|Total of all reporting groups
1250743|NCT00091962|B3|Baseline|Non-Depressed Control|Observational only
1250744|NCT00091962|B2|Baseline|Depressed Usual Care|"Control group will receive usual care for depression~Usual Care: Usual care for depression"
1250745|NCT00091962|B1|Baseline|Depressed Intervention|"Collaborative care program for depression involving a telephone-based nurse care manager~Counseling: Counseling program~Pharmacotherapy: Medication to treat depression"
1250746|NCT00091962|P3|Participant Flow|Non-Depressed Control Group|
1250747|NCT00091962|P2|Participant Flow|Depressed Usual Care|"Control group will receive usual care for depression~Usual Care: Usual care for depression"
1250748|NCT00091962|P1|Participant Flow|Depressed Intervention|"Collaborative care program for depression involving a telephone-based nurse care manager~Counseling: Counseling program~Pharmacotherapy: Medication to treat depression"
1250749|NCT00091962|O3|Outcome|Non-Depressed Control|Non-depressed control group with no intervention
1250750|NCT00091962|O2|Outcome|Depressed Usual Care|"Usual care for depression by patients' PCP"
1250751|NCT00091962|O1|Outcome|Depressed Intervention|"Telephone-based, nurse-delivered Collaborative Care program for depression; Involving: Psychoeducation; workbook for depression self-care; initiation or adjustment of antidepressant pharmacotherapy prescribed under their PCPs’ direction; referral to mental health specialist~Psychoeducation; Treatment recommendations: Counseling program~Pharmacotherapy: Medication to treat depression"
1250752|NCT00091962|O3|Outcome|Non-Depressed Control|Non-depressed control group with no intervention
1250753|NCT00091962|O2|Outcome|Depressed Usual Care|"Usual care for depression by patients' PCP"
1250754|NCT00091962|O1|Outcome|Depressed Intervention|"Telephone-based, nurse-delivered Collaborative Care program for depression; Involving: Psychoeducation; workbook for depression self-care; initiation or adjustment of antidepressant pharmacotherapy prescribed under their PCPs’ direction; referral to mental health specialist~Psychoeducation; Treatment recommendations: Counseling program~Pharmacotherapy: Medication to treat depression"
1250755|NCT00091962|O3|Outcome|Non-Depressed Control Group|Non-depressed groups as Control to see the natural course of recovery after CABG
1250756|NCT00091962|O2|Outcome|Depressed Usual Care|"Control group will receive usual care for depression~Usual Care: Usual care for depression"
1250757|NCT00091962|O1|Outcome|Depressed Intervention|"Collaborative care program for depression involving a telephone-based nurse care manager~Counseling: Counseling program~Pharmacotherapy: Medication to treat depression"
1250758|NCT00091962|O3|Outcome|Non-Depressed Control|Non-depressed control group with no intervention
1250759|NCT00091962|O2|Outcome|Depressed Usual Care|"Usual care for depression by patients' PCP"
1250760|NCT00091962|O1|Outcome|Depressed Intervention|"Telephone-based, nurse-delivered Collaborative Care program for depression; Involving: Psychoeducation; workbook for depression self-care; initiation or adjustment of antidepressant pharmacotherapy prescribed under their PCPs’ direction; referral to mental health specialist~Psychoeducation; Treatment recommendations: Counseling program~Pharmacotherapy: Medication to treat depression"
1250761|NCT00091962|E3|Reported Event|Non-Depressed Control|Non-depressed control group with no intervention
1250762|NCT00091962|E2|Reported Event|Depressed Usual Care|"Usual care for depression by patients' PCP"
1250763|NCT00091962|E1|Reported Event|Depressed Intervention|"Telephone-based, nurse-delivered Collaborative Care program for depression; Involving: Psychoeducation; workbook for depression self-care; initiation or adjustment of antidepressant pharmacotherapy prescribed under their PCPs’ direction; referral to mental health specialist~Psychoeducation; Treatment recommendations: Counseling program~Pharmacotherapy: Medication to treat depression"
1250764|NCT00091949|B3|Baseline|Total|Total of all reporting groups
1250765|NCT00091949|B2|Baseline|Placebo|placebo: an inactive substance
1250766|NCT00091949|B1|Baseline|Pioglitazone|pioglitazone: a thiazolidinedione drug
1250767|NCT00091949|P2|Participant Flow|Placebo|placebo: an inactive substance
1250768|NCT00091949|P1|Participant Flow|Pioglitazone|pioglitazone: a thiazolidinedione drug
1250769|NCT00091949|O2|Outcome|Placebo|placebo: an inactive substance
1250770|NCT00091949|O1|Outcome|Pioglitazone|pioglitazone: a thiazolidinedione drug
1250771|NCT00091949|O2|Outcome|Placebo|placebo: an inactive substance
1250772|NCT00091949|O1|Outcome|Pioglitazone|pioglitazone: a thiazolidinedione drug
1250773|NCT00091949|O2|Outcome|Placebo|placebo: an inactive substance
1250780|NCT00091949|O1|Outcome|Pioglitazone|pioglitazone: a thiazolidinedione drug
1250781|NCT00091949|O2|Outcome|Placebo|placebo: an inactive substance
1250782|NCT00091949|O1|Outcome|Pioglitazone|pioglitazone: a thiazolidinedione drug
1250783|NCT00091949|E2|Reported Event|Placebo|placebo: an inactive substance
1250784|NCT00091949|E1|Reported Event|Pioglitazone|pioglitazone: a thiazolidinedione drug
1250785|NCT00091572|B3|Baseline|Total|Total of all reporting groups
1250786|NCT00091572|B2|Baseline|Dacarbazine|dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
1250787|NCT00091572|B1|Baseline|Temozolomide|"temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days (7 days on / 7 days off continuously)"
1250788|NCT00091572|P2|Participant Flow|Dacarbazine|dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
1250789|NCT00091572|P1|Participant Flow|Temozolomide|"temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days (7 days on / 7 days off continuously)"
1250790|NCT00091572|O2|Outcome|Dacarbazine|dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
1250791|NCT00091572|O1|Outcome|Temozolomide|"temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days (7 days on / 7 days off continuously)"
1250792|NCT00091572|O2|Outcome|Dacarbazine|dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
1250793|NCT00091572|O1|Outcome|Temozolomide|"temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days (7 days on / 7 days off continuously)"
1250794|NCT00091572|O2|Outcome|Dacarbazine|dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
1250795|NCT00091572|O1|Outcome|Temozolomide|"temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days (7 days on / 7 days off continuously)"
1250796|NCT00091572|O2|Outcome|Dacarbazine|dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
1250797|NCT00091572|O1|Outcome|Temozolomide|"temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days (7 days on / 7 days off continuously)"
1250798|NCT00091572|E2|Reported Event|Dacarbazine|
1250799|NCT00091572|E1|Reported Event|Temozolomide|
1250800|NCT00091507|B3|Baseline|Total|Total of all reporting groups
1250801|NCT00091507|B2|Baseline|Placebo|Dextrose 5%
1250802|NCT00091507|B1|Baseline|GIK --|GIK = glucose-insulin-potassium
1250803|NCT00091507|P2|Participant Flow|Placebo|Dextrose 5%
1250804|NCT00091507|P1|Participant Flow|GIK --|GIK = glucose-insulin-potassium
1250805|NCT00091507|O2|Outcome|Placebo|Dextrose 5%
1250806|NCT00091507|O1|Outcome|GIK --|GIK = glucose-insulin-potassium
1250807|NCT00091507|O2|Outcome|Placebo|Dextrose 5%
1250808|NCT00091507|O1|Outcome|GIK --|GIK = glucose-insulin-potassium
1250809|NCT00091507|O2|Outcome|Placebo|Dextrose 5%
1250810|NCT00091507|O1|Outcome|GIK --|GIK = glucose-insulin-potassium
1250811|NCT00091507|O2|Outcome|Placebo|Dextrose 5%
1250812|NCT00091507|O1|Outcome|GIK --|GIK = glucose-insulin-potassium
1250813|NCT00091507|O2|Outcome|Placebo|Dextrose 5%
1250814|NCT00091507|O1|Outcome|GIK --|GIK = glucose-insulin-potassium
1250815|NCT00091507|E2|Reported Event|Placebo|Dextrose 5%
1250816|NCT00091507|E1|Reported Event|GIK --|GIK = glucose-insulin-potassium
1250817|NCT00091442|B3|Baseline|Total|Total of all reporting groups
1250818|NCT00091442|B2|Baseline|DOXIL+Docetaxel|DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
1250819|NCT00091442|B1|Baseline|Docetaxel|Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
1250820|NCT00091442|P2|Participant Flow|DOXIL+Docetaxel|DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
1250821|NCT00091442|P1|Participant Flow|Docetaxel|Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
1250822|NCT00091442|O2|Outcome|DOXIL+Docetaxel|DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
1250823|NCT00091442|O1|Outcome|Docetaxel|Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
1250824|NCT00091442|O2|Outcome|DOXIL+Docetaxel|DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
1250825|NCT00091442|O1|Outcome|Docetaxel|Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
1250901|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
1250826|NCT00091442|O2|Outcome|DOXIL+Docetaxel|DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
1250827|NCT00091442|O1|Outcome|Docetaxel|Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
1250828|NCT00091442|E2|Reported Event|DOXIL+Docetaxel|DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
1250829|NCT00091442|E1|Reported Event|Docetaxel|Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
1250830|NCT00091390|B1|Baseline|EBRT and HDR Brachytherapy Boost|External beam radiation therapy (EBRT) and high dose rate (HDR) brachytherapy boost.
1250831|NCT00091390|P1|Participant Flow|EBRT and HDR Brachytherapy Boost|External beam radiation therapy (EBRT) and high dose rate (HDR) brachytherapy boost.
1250832|NCT00091390|O1|Outcome|EBRT and HDR Brachytherapy Boost|External beam radiation therapy (EBRT) and high dose rate (HDR) brachytherapy boost.
1250833|NCT00091390|E1|Reported Event|EBRT and HDR Brachytherapy Boost|External beam radiation therapy (EBRT) and high dose rate (HDR) brachytherapy boost.
1250834|NCT00091273|B1|Baseline|Single Arm|
1250835|NCT00091273|P1|Participant Flow|Single Arm|
1250840|NCT00091260|B1|Baseline|Revlimid|"lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~dexamethasone: dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~lenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone"
1250841|NCT00091260|P1|Participant Flow|Revlimid|"lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~dexamethasone: dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~lenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone"
1250842|NCT00091260|O1|Outcome|Revlimid|"lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~dexamethasone: dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~lenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone"
1250843|NCT00091260|O1|Outcome|Revlimid|"lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg BID) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~dexamethasone: dexamethasone 20 mg daily (10 mg BID) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~lenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone"
1250844|NCT00091260|O1|Outcome|Revlimid|"lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~dexamethasone: dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~lenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone"
1250845|NCT00091260|E1|Reported Event|Revlimid|"lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~dexamethasone: dexamethasone 20 mg daily (10 mg twice daily) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.~lenalidomide: 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone"
1250846|NCT00091169|B3|Baseline|Total|Total of all reporting groups
1250847|NCT00091169|B2|Baseline|Placebo|"Patients receive oral placebo twice daily on weeks 1-4.~placebo: Given orally"
1250848|NCT00091169|B1|Baseline|Levocarnitine|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.~levocarnitine: Given orally"
1250849|NCT00091169|P2|Participant Flow|Placebo|"Patients receive oral placebo twice daily on weeks 1-4.~placebo: Given orally"
1250850|NCT00091169|P1|Participant Flow|Levocarnitine|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.~levocarnitine: Given orally"
1250851|NCT00091169|O2|Outcome|Arm II|"Patients receive oral placebo twice daily on weeks 1-4.~placebo: Given orally"
1250852|NCT00091169|O1|Outcome|Arm I|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.~levocarnitine: Given orally"
1250853|NCT00091169|O2|Outcome|Arm II|"Patients receive oral placebo twice daily on weeks 1-4.~placebo: Given orally"
1250854|NCT00091169|O1|Outcome|Arm I|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.~levocarnitine: Given orally"
1250855|NCT00091169|O2|Outcome|Placebo|"Patients receive oral placebo twice daily on weeks 1-4.~placebo: Given orally"
1250856|NCT00091169|O1|Outcome|Levocarnitine|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.~levocarnitine: Given orally"
1250857|NCT00091169|O2|Outcome|Placebo|"Patients receive oral placebo twice daily on weeks 1-4.~placebo: Given orally"
1250858|NCT00091169|O1|Outcome|Levocarnitine|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.~levocarnitine: Given orally"
1250859|NCT00091169|O2|Outcome|Placebo|"Patients receive oral placebo twice daily on weeks 1-4.~placebo: Given orally"
1250860|NCT00091169|O1|Outcome|Levocarnitine|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.~levocarnitine: Given orally"
1250861|NCT00091169|O2|Outcome|Placebo|"Patients receive oral placebo twice daily on weeks 1-4.~placebo: Given orally"
1250862|NCT00091169|O1|Outcome|Levocarnitine|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.~levocarnitine: Given orally"
1250863|NCT00091169|E2|Reported Event|Placebo|Patients receive oral placebo twice daily on weeks 1-4. placebo: Given orally
1250864|NCT00091169|E1|Reported Event|Levocarnitine|Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4. levocarnitine: Given orally
1250865|NCT00091026|B3|Baseline|Total|Total of all reporting groups
1250866|NCT00091026|B2|Baseline|Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)|Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
1250867|NCT00091026|B1|Baseline|Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)|Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
1250868|NCT00091026|P2|Participant Flow|Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)|Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
1250869|NCT00091026|P1|Participant Flow|Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)|Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
1250870|NCT00091026|O2|Outcome|Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)|Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
1250871|NCT00091026|O1|Outcome|Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)|Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
1250872|NCT00091026|O2|Outcome|Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)|Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
1250913|NCT00090779|E2|Reported Event|DT Arm|DT arm participants received no Treatment
1250873|NCT00091026|O1|Outcome|Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)|Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
1250874|NCT00091026|O2|Outcome|Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)|Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
1250875|NCT00091026|O1|Outcome|Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)|Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
1250876|NCT00091026|E2|Reported Event|Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)|Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
1250877|NCT00091026|E1|Reported Event|Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)|Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
1250878|NCT00090987|B1|Baseline|Imatinib Mesylate (Gleevec)|Imatinib mesylate (Gleevec) is administered 400 mg orally once a day
1250879|NCT00090987|P1|Participant Flow|Imatinib Mesylate (Gleevec)|Imatinib mesylate (Gleevec) is administered 400 mg orally once a day
1250880|NCT00090987|O1|Outcome|Imatinib Mesylate (Gleevec)|Imatinib mesylate (Gleevec) is administered 400 mg orally once a day
1250881|NCT00090987|E1|Reported Event|Imatinib Mesylate (Gleevec)|Imatinib mesylate (Gleevec) is administered 400 mg orally once a day
1250882|NCT00090844|B3|Baseline|Total|Total of all reporting groups
1250883|NCT00090844|B2|Baseline|no Triptorelin|no GnRH analogue (triptorelin) during chemotherapy
1250884|NCT00090844|B1|Baseline|Triptorelin|GnRH analogue (triptorelin) during chemotherapy
1250885|NCT00090844|P2|Participant Flow|no Triptorelin|No Gonadotropin-releasing hormone [GnRH] analogue (triptorelin) during chemotherapy
1250886|NCT00090844|P1|Participant Flow|Triptorelin|"Gonadotropin-releasing hormone [GnRH] analogue (triptorelin) during chemotherapy~triptorelin : 3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection"
1250887|NCT00090844|O2|Outcome|no Triptorelin|No GnRH analogue (triptorelin) during chemotherapy
1250888|NCT00090844|O1|Outcome|Triptorelin|"GnRH analogue (triptorelin) during chemotherapy~triptorelin : 3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection"
1250889|NCT00090844|E2|Reported Event|no Triptorelin|No GnRH analogue (triptorelin) during chemotherapy
1250890|NCT00090844|E1|Reported Event|Triptorelin|"GnRH analogue (triptorelin) during chemotherapy~triptorelin : 3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection"
1250891|NCT00090779|B3|Baseline|Total|Total of all reporting groups
1250892|NCT00090779|B2|Baseline|DT Arm|DT arm participants received no Treatment
1250893|NCT00090779|B1|Baseline|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
1250894|NCT00090779|P2|Participant Flow|DT Arm|On step 1, DT arm participants received no Treatment,unless subsequent disease progression criteria were met. Participants in DT arm who met clinical, virologic or immunologic criteria for treatment initiation entered step 2 and initiated ART. At the time of the end of original randomized study, study participants in DT arm who did not enter Step 2 and did not initiate ART without meeting eligibility criteria for Step 2 had the opportunity to take part in a long-term follow-up study (step 3) for up to a total duration of five years in order to ascertain information about HIV-1 RNA, CD4+ T-cell count, occurrence of CDC Category B or C diagnoses, and initiation of ART.
1250895|NCT00090779|P1|Participant Flow|IT Arm|On step 1, IT arm participants received 36 weeks of emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily. Participants in IT arm who met clinical, virologic or immunologic criteria for treatment re-initiation entered step 2 and re-initiated ART. At the time of the end of original randomized study, study participants in IT arm who did not enter Step 2 and did not initiate ART without meeting eligibility criteria for Step 2 had the opportunity to take part in a long-term follow-up study (step 3) for up to a total duration of five years in order to ascertain information about HIV-1 RNA, CD4+ T-cell count, occurrence of CDC Category B or C diagnoses, and initiation of ART.
1250896|NCT00090779|O2|Outcome|DT Arm|DT arm participants received no Treatment
1250897|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
1250898|NCT00090779|O2|Outcome|DT Arm|DT arm participants received no Treatment
1250899|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
1250900|NCT00090779|O2|Outcome|DT Arm|DT arm participants received no Treatment
1251005|NCT00090584|O2|Outcome|Combination at 10 Weeks|10 week value for women in combination arm
1250902|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
1250903|NCT00090779|O2|Outcome|DT Arm|DT arm participants received no Treatment
1250904|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
1250905|NCT00090779|O2|Outcome|DT Arm|DT arm participants received no Treatment
1250906|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
1250907|NCT00090779|O2|Outcome|DT Arm|DT arm participants received no Treatment
1250908|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
1250909|NCT00090779|O2|Outcome|DT Arm|DT arm participants received no Treatment
1250910|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
1250911|NCT00090779|O2|Outcome|DT Arm|DT arm participants received no Treatment
1250912|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
1251129|NCT00090259|O1|Outcome|Losartan 50 mg|
1250914|NCT00090779|E1|Reported Event|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
1250915|NCT00090766|B4|Baseline|Total|Total of all reporting groups
1250916|NCT00090766|B3|Baseline|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250917|NCT00090766|B2|Baseline|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250918|NCT00090766|B1|Baseline|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 milligrams (mg) once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250919|NCT00090766|P3|Participant Flow|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250920|NCT00090766|P2|Participant Flow|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250921|NCT00090766|P1|Participant Flow|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 milligrams (mg) once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * body surface area [BSA] * creatinine clearance [CrCLS]).
1250922|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250923|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250924|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250925|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250926|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250927|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250928|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250929|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250930|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250931|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1251006|NCT00090584|O1|Outcome|Combination at Baseline|Baseline value for women in combination therapy
1250932|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250933|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250934|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250935|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250936|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250937|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250938|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250939|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250940|NCT00090766|O1|Outcome|Overall Study|All participants who received at least one dose of valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250941|NCT00090766|O1|Outcome|Overall Study|All participants who received at least one dose of valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250942|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250943|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250944|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250945|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250946|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250947|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250948|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250949|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250950|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250951|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Participants aged >= 12 years received a once daily oral dose (solution or tablets) of valganciclovir from the time of kidney transplant for up to 100 days post-transplant. Dose (in mg) was calculated using the algorithm (7 * body surface area * creatinine clearance).
1250952|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250953|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250954|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250955|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250956|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250957|NCT00090766|E3|Reported Event|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250958|NCT00090766|E2|Reported Event|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250959|NCT00090766|E1|Reported Event|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
1250960|NCT00090753|B3|Baseline|Total|Total of all reporting groups
1250961|NCT00090753|B2|Baseline|Comparator ESA|Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
1250962|NCT00090753|B1|Baseline|Methoxy Polyethylene Glycol-Epoetin Beta|Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
1250963|NCT00090753|P2|Participant Flow|Comparator ESA|Patients received the same comparator erythropoiesis stimulating agent (ESA) [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
1250964|NCT00090753|P1|Participant Flow|Methoxy Polyethylene Glycol-Epoetin Beta|Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta (Mircera) via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
1250965|NCT00090753|O2|Outcome|Comparator ESA|Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
1250966|NCT00090753|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
1250967|NCT00090753|O2|Outcome|Comparator ESA|Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
1250968|NCT00090753|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
1251007|NCT00090584|O6|Outcome|Drug Only at 8 Months|8 month value for women randomized to drug only
1251008|NCT00090584|O5|Outcome|Drug Only at 10 Weeks|10 week value for women randomized to drug only
1250969|NCT00090753|E2|Reported Event|Comparator ESA|Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
1250970|NCT00090753|E1|Reported Event|Methoxy Polyethylene Glycol-Epoetin Beta|Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
1250971|NCT00090610|B3|Baseline|Total|Total of all reporting groups
1250972|NCT00090610|B2|Baseline|Arm 2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
1250973|NCT00090610|B1|Baseline|Arm 1|Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
1250974|NCT00090610|P2|Participant Flow|Arm 2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
1250975|NCT00090610|P1|Participant Flow|Arm 1|Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
1250976|NCT00090610|O2|Outcome|Arm 2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
1250977|NCT00090610|O1|Outcome|Arm 1|Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
1250978|NCT00090610|O2|Outcome|Arm 2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
1250979|NCT00090610|O1|Outcome|Arm 1|Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
1250980|NCT00090610|O2|Outcome|Arm 2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
1250981|NCT00090610|O1|Outcome|Arm 1|Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
1250982|NCT00090610|O2|Outcome|Arm 2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
1250983|NCT00090610|O1|Outcome|Arm 1|Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
1250984|NCT00090610|O2|Outcome|Arm 2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
1250985|NCT00090610|O1|Outcome|Arm 1|Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
1250986|NCT00090610|E2|Reported Event|Arm2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
1250987|NCT00090610|E1|Reported Event|Arm 1|Docetaxel 30 mg/m2 intravenously (IV) on Days 1 and 8, combined with carboplatin area under the concentration versus time curve (AUC) 6 IV on Day 1, repeated every 21 days for 6 cycles or until disease progression (DP) (whichever occurred first).
1250988|NCT00090584|B3|Baseline|Total|Total of all reporting groups
1250989|NCT00090584|B2|Baseline|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
1250990|NCT00090584|B1|Baseline|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
1250991|NCT00090584|P2|Participant Flow|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
1250992|NCT00090584|P1|Participant Flow|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
1250993|NCT00090584|O2|Outcome|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
1250994|NCT00090584|O1|Outcome|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
1250995|NCT00090584|O2|Outcome|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
1250996|NCT00090584|O1|Outcome|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
1250997|NCT00090584|O2|Outcome|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
1250998|NCT00090584|O1|Outcome|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
1250999|NCT00090584|O2|Outcome|Drug Only at 10 Weeks|10 week value for women randomized to drug only
1251000|NCT00090584|O1|Outcome|Combination at 10 Weeks|10 week value for women in combination arm
1251001|NCT00090584|O6|Outcome|Drug Only at 8 Months|8 month value for women randomized to drug only
1251002|NCT00090584|O5|Outcome|Drug Only at 10 Weeks|10 week value for women randomized to drug only
1251003|NCT00090584|O4|Outcome|Drug Only at Baseline|Baseline value for women randomized to drug only
1251004|NCT00090584|O3|Outcome|Combiniation at 8 Months|8 months value from women in combination arm
1251009|NCT00090584|O4|Outcome|Drug Only at Baseline|Baseline value for women randomized to drug only
1251010|NCT00090584|O3|Outcome|Combiniation at 8 Months|8 months value from women in combination arm
1251011|NCT00090584|O2|Outcome|Combination at 10 Weeks|10 week value for women in combination arm
1251012|NCT00090584|O1|Outcome|Combination at Baseline|Baseline value for women in combination therapy
1251013|NCT00090584|O2|Outcome|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
1251014|NCT00090584|O1|Outcome|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
1251015|NCT00090584|O2|Outcome|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
1251016|NCT00090584|O1|Outcome|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
1251017|NCT00090584|O2|Outcome|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
1251018|NCT00090584|O1|Outcome|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
1251130|NCT00090259|O2|Outcome|Losartan 150 mg|
1251019|NCT00090584|E2|Reported Event|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
1251020|NCT00090584|E1|Reported Event|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
1251021|NCT00090545|B3|Baseline|Total|Total of all reporting groups
1251022|NCT00090545|B2|Baseline|Second Stage - Increased Accrual|"Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.~Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles"
1251023|NCT00090545|B1|Baseline|First Stage - Disease Progression|"The first stage was to rule out the probability of 4 month progression free survival.~Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles."
1251024|NCT00090545|P2|Participant Flow|Second Stage - Increased Accrual|"Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.~400 mg BAY 43-9006 orally twice daily in 28 day cycles."
1251025|NCT00090545|P1|Participant Flow|First Stage - Disease Progression|"The first stage was to rule out the probability of 4 month progression free survival.~400 mg BAY 43-9006 orally twice daily in 28 day cycles."
1251026|NCT00090545|O2|Outcome|Second Stage - Increased Accrual|"Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.~Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles."
1251027|NCT00090545|O1|Outcome|First Stage - Disease Progression|"The first stage was to rule out the probability of 4 month progression free survival.~Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles."
1251028|NCT00090545|O2|Outcome|Second Stage - Increased Accrual|"Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.~400 mg BAY 43-9006 orally twice daily in 28 day cycles."
1251029|NCT00090545|O1|Outcome|First Stage - Disease Progression|"The first stage was to rule out the probability of 4 month progression free survival.~400 mg BAY 43-9006 orally twice daily in 28 day cycles."
1251030|NCT00090545|E2|Reported Event|Second Stage - Increased Accrual|"Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.~400 mg BAY 43-9006 orally twice daily in 28 day cycles."
1251031|NCT00090545|E1|Reported Event|First Stage - Disease Progression|"The first stage was to rule out the probability of 4 month progression free survival.~Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles."
1251032|NCT00090519|B3|Baseline|Total|Total of all reporting groups
1251033|NCT00090519|B2|Baseline|Placebo|QD oral for up to 36 months
1251034|NCT00090519|B1|Baseline|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
1251035|NCT00090519|P2|Participant Flow|Placebo|QD oral for up to 36 months
1251036|NCT00090519|P1|Participant Flow|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
1251037|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
1251038|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
1251039|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
1251040|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
1251041|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
1251042|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
1251043|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
1251044|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
1251045|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
1251046|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
1251047|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
1251048|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
1251049|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
1251050|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
1251051|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
1251052|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
1251053|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
1251054|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
1251055|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
1251056|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
1251057|NCT00090519|E2|Reported Event|Placebo|QD oral for up to 36 months
1251058|NCT00090519|E1|Reported Event|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
1251089|NCT00090363|O3|Outcome|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
1251090|NCT00090363|O2|Outcome|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
1251059|NCT00090493|B1|Baseline|MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY|Treatment will consist of receiving peptide (small pieces of proteins) vaccinations as a shot just under the skin (subcutaneous). Purpose is to generate anti-myeloma T-cells with will kill only myeloma cells. Three injections of peptide will be given subcutaneously together with the adjuvant GM-CSF at 2-week intervals.
1251060|NCT00090493|P1|Participant Flow|MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY|"Treatment will consist of receiving peptide (small pieces of proteins)vaccinations as a shot just under the skin (subcutaneous). We have chosen to vaccinate with peptides derived from cancer proteins found in myeloma and other cancers. Purpose: to generate anti-myeloma T-cells which will kill only myeloma cells.~MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY : 3 injections with 300µg/injection (in 1.5mls) of peptide will be given subcutaneously together with the adjuvant GM-CSF at 500µg (same site in 0.5 mls) at two-week intervals.~MAGE-A3 : vaccinations at 2-week intervals (days 22,36,50) with the MAGE-A3 or NY-ESO-1 peptide and GM-CSF adjuvant. The peptides will be given s.c. in a dose of 300μg; GM-CSF (250μg) will be administered to promote attraction, maturation and longevity of DCs. #2 will be thawed and re-infused after transplant on day 81 and any anti-myeloma T-cells in this leukapheresis product will be boosted immediately by re-vaccinating."
1251131|NCT00090259|O1|Outcome|Losartan 50 mg|
1251132|NCT00090259|O2|Outcome|Losartan 150 mg|
1251133|NCT00090259|O1|Outcome|Losartan 50 mg|
1251134|NCT00090259|O2|Outcome|Losartan 150 mg|
1251135|NCT00090259|O1|Outcome|Losartan 50 mg|
1251136|NCT00090259|O2|Outcome|Losartan 150 mg|
1251137|NCT00090259|O1|Outcome|Losartan 50 mg|
1251061|NCT00090493|O1|Outcome|MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY|"Treatment will consist of receiving peptide (small pieces of proteins)vaccinations as a shot just under the skin (subcutaneous). We have chosen to vaccinate with peptides derived from cancer proteins found in myeloma and other cancers. Purpose: to generate anti-myeloma T-cells which will kill only myeloma cells.~MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY : 3 injections with 300µg/injection (in 1.5mls) of peptide will be given subcutaneously together with the adjuvant GM-CSF at 500µg (same site in 0.5 mls) at two-week intervals.~MAGE-A3 : vaccinations at 2-week intervals (days 22,36,50) with the MAGE-A3 or NY-ESO-1 peptide and GM-CSF adjuvant. The peptides will be given s.c. in a dose of 300μg; GM-CSF (250μg) will be administered to promote attraction, maturation and longevity of DCs. #2 will be thawed and re-infused after transplant on day 81 and any anti-myeloma T-cells in this leukapheresis product will be boosted immediately by re-vaccinating."
1251062|NCT00090493|E1|Reported Event|MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY|"Treatment will consist of receiving peptide (small pieces of proteins)vaccinations as a shot just under the skin (subcutaneous). We have chosen to vaccinate with peptides derived from cancer proteins found in myeloma and other cancers. Purpose: to generate anti-myeloma T-cells which will kill only myeloma cells.~MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY : 3 injections with 300µg/injection (in 1.5mls) of peptide will be given subcutaneously together with the adjuvant GM-CSF at 500µg (same site in 0.5 mls) at two-week intervals.~MAGE-A3 : vaccinations at 2-week intervals (days 22,36,50) with the MAGE-A3 or NY-ESO-1 peptide and GM-CSF adjuvant. The peptides will be given s.c. in a dose of 300μg; GM-CSF (250μg) will be administered to promote attraction, maturation and longevity of DCs. #2 will be thawed and re-infused after transplant on day 81 and any anti-myeloma T-cells in this leukapheresis product will be boosted immediately by re-vaccinating."
1251063|NCT00090402|B4|Baseline|Total|Total of all reporting groups
1251064|NCT00090402|B3|Baseline|Fish Oil Plus Lipoic Acid|Fish oil concnetrate, daily dose 3 grams per day containing 675 mg docosahexanioic acid and 975 mg eicosapentanoic acid plus alpha lipoic acid (racemic) daily dose 600 mg taken for 12 months.
1251065|NCT00090402|B2|Baseline|Fish Oil|Fish oil concnetrate, daily dose 3 grams per day containing 675 mg docosahexanoic acid and 975 mg eicosapentanoic acid, taken for 12 months.
1251066|NCT00090402|B1|Baseline|Placebo|Placebo oil (soybean oil), daily dose 3 grams taken for 12 months
1251067|NCT00090402|P3|Participant Flow|Fish Oil Plus Lipoic Acid|Fish oil concnetrate, daily dose 3 grams per day containing 675 mg docosahexanioic acid and 975 mg eicosapentanoic acid plus alpha lipoic acid (racemic) daily dose 600 mg taken for 12 months.
1251068|NCT00090402|P2|Participant Flow|Fish Oil|Fish oil concnetrate, daily dose 3 grams per day containing 675 mg docosahexanoic acid and 975 mg eicosapentanoic acid, taken for 12 months.
1251069|NCT00090402|P1|Participant Flow|Placebo|Placebo oil (soybean oil), daily dose 3 grams taken for 12 months
1251070|NCT00090402|O3|Outcome|Fish Oil Plus Lipoic Acid|Fish oil concnetrate, daily dose 3 grams per day containing 675 mg docosahexanioic acid and 975 mg eicosapentanoic acid plus alpha lipoic acid (racemic) daily dose 600 mg taken for 12 months.
1251071|NCT00090402|O2|Outcome|Fish Oil|Fish oil concnetrate, daily dose 3 grams per day containing 675 mg docosahexanoic acid and 975 mg eicosapentanoic acid, taken for 12 months.
1251072|NCT00090402|O1|Outcome|Placebo|Placebo oil (soybean oil), daily dose 3 grams taken for 12 months
1251073|NCT00090402|E3|Reported Event|Fish Oil Plus Lipoic Acid|
1251074|NCT00090402|E2|Reported Event|Fish Oil|
1251075|NCT00090402|E1|Reported Event|Placebo|
1251076|NCT00090363|B4|Baseline|Total|Total of all reporting groups
1251077|NCT00090363|B3|Baseline|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
1251078|NCT00090363|B2|Baseline|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
1251079|NCT00090363|B1|Baseline|Placebo|Matching placebo oral tablet once daily, with best supportive care
1251080|NCT00090363|P3|Participant Flow|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
1251081|NCT00090363|P2|Participant Flow|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
1251082|NCT00090363|P1|Participant Flow|Placebo|Matching placebo oral tablet once daily, with best supportive care
1251083|NCT00090363|O3|Outcome|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
1251084|NCT00090363|O2|Outcome|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
1251085|NCT00090363|O1|Outcome|Placebo|Matching placebo oral tablet once daily, with best supportive care
1251086|NCT00090363|O3|Outcome|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
1251087|NCT00090363|O2|Outcome|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
1251088|NCT00090363|O1|Outcome|Placebo|Matching placebo oral tablet once daily, with best supportive care
1251091|NCT00090363|O1|Outcome|Placebo|Matching placebo oral tablet once daily, with best supportive care
1251092|NCT00090363|O3|Outcome|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
1251093|NCT00090363|O2|Outcome|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
1251094|NCT00090363|O1|Outcome|Placebo|Matching placebo oral tablet once daily, with best supportive care
1251095|NCT00090363|O3|Outcome|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
1251096|NCT00090363|O2|Outcome|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
1251097|NCT00090363|O1|Outcome|Placebo|Matching placebo oral tablet once daily, with best supportive care
1251098|NCT00090363|E3|Reported Event|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
1251099|NCT00090363|E2|Reported Event|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
1251100|NCT00090363|E1|Reported Event|Placebo|Matching placebo oral tablet once daily, with best supportive care
1251101|NCT00090285|B3|Baseline|Total|Total of all reporting groups
1251102|NCT00090285|B2|Baseline|Placebo|Participants who started the base study vaccination period
1251103|NCT00090285|B1|Baseline|qHPV Vaccine|Participants who started the base study vaccination period
1251138|NCT00090259|E2|Reported Event|Losartan 150 mg|
1251104|NCT00090285|P4|Participant Flow|EXT1: Incomplete qHPV Regimen in Base Study|Participants who received placebo and participants who received only 1 dose of qHPV vaccine in the base study were offered a complete 3-dose qHPV vaccine regimen (administered at EXT1 Day 1, Month 2 and Month 6). Participants who received only 2 doses of qHPV vaccine in the base study were offered a single additional dose of qHPV vaccine (administered at EXT1 Day 1). Participants were followed to EXT1 Month 7.
1251105|NCT00090285|P3|Participant Flow|EXT1: Placebo in Base Study|Participants in the placebo arm in the base study were offered 3 doses of open-label qHPV vaccine at EXT1 Day 1, Month 2 and Month 6. Participants were followed to EXT1 Month 7.
1251106|NCT00090285|P2|Participant Flow|Placebo in Base Study|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36."
1251107|NCT00090285|P1|Participant Flow|qHPV Vaccine in Base Study|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36."
1251108|NCT00090285|O2|Outcome|Placebo: Base Study and Followup|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36. The at-risk population was participants who received ≥ 1 placebo injection in the base study."
1251109|NCT00090285|O1|Outcome|qHPV Vaccine: Base Study and Followup|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36. The at-risk population was participants who received ≥ 1 qHPV vaccination in the base study."
1251110|NCT00090285|O2|Outcome|Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36. Not all participants reached Month 36 prior to the cut-off for the pre-specified analysis."
1251111|NCT00090285|O1|Outcome|qHPV Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36. Not all participants reached Month 36 prior to the cut-off for the pre-specified analysis."
1251112|NCT00090285|O2|Outcome|Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36. Not all participants reached Month 36 prior to the cut-off for the pre-specified analysis."
1251113|NCT00090285|O1|Outcome|qHPV Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36. Not all participants reached Month 36 prior to the cut-off for the pre-specified analysis."
1251114|NCT00090285|O2|Outcome|Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36. Not all participants reached Month 36 prior to the cut-off for the pre-specified analysis."
1251115|NCT00090285|O1|Outcome|qHPV Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36. Not all participants reached Month 36 prior to the cut-off for the pre-specified analysis."
1251116|NCT00090285|O2|Outcome|Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36. Not all participants reached Month 36 prior to the cut-off for the pre-specified analysis."
1251117|NCT00090285|O1|Outcome|qHPV Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36. Not all participants reached Month 36 prior to the cut-off for the pre-specified analysis."
1251118|NCT00090285|O2|Outcome|Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36. Not all participants reached Month 36 prior to the cut-off for the pre-specified analysis."
1251119|NCT00090285|O1|Outcome|qHPV Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36. Not all participants reached Month 36 prior to the cut-off for the pre-specified analysis."
1251286|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
1251120|NCT00090285|E3|Reported Event|qHPV Vaccine: EXT1|Participants who received placebo and participants who received only 1 dose of qHPV vaccine in the base study were offered a complete 3-dose qHPV vaccine regimen (administered at EXT1 Day 1, Month 2 and Month 6). Participants who received only 2 doses of qHPV vaccine in the base study were offered a single additional dose of qHPV vaccine (administered at EXT1 Day 1). Participants were followed to EXT1 Month 7. The at-risk population was participants who received ≥ 1 qHPV vaccination in EXT1 and had follow-up data.
1251121|NCT00090285|E2|Reported Event|Placebo: Base Study|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36. The at-risk population was participants who received ≥ 1 placebo injection in the base study."
1251122|NCT00090285|E1|Reported Event|qHPV Vaccine: Base Study|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36. The at-risk population was participants who received ≥ 1 qHPV vaccination in the base study."
1251123|NCT00090259|B3|Baseline|Total|Total of all reporting groups
1251124|NCT00090259|B2|Baseline|Losartan 150 mg|
1251125|NCT00090259|B1|Baseline|Losartan 50 mg|
1251126|NCT00090259|P2|Participant Flow|Losartan 150 mg|
1251127|NCT00090259|P1|Participant Flow|Losartan 50 mg|
1251128|NCT00090259|O2|Outcome|Losartan 150 mg|
1251141|NCT00090233|B2|Baseline|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
1251142|NCT00090233|B1|Baseline|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
1251143|NCT00090233|P2|Participant Flow|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season postvaccination. The rotavirus season for each site was prospectively determined using historical epidemiologic data.
1251144|NCT00090233|P1|Participant Flow|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season postvaccination. The rotavirus season for each site was prospectively determined using historical epidemiologic data.
1251145|NCT00090233|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
1251146|NCT00090233|O1|Outcome|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
1251147|NCT00090233|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
1251148|NCT00090233|O1|Outcome|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
1251149|NCT00090233|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
1251150|NCT00090233|O1|Outcome|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
1251151|NCT00090233|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
1251152|NCT00090233|O1|Outcome|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
1251153|NCT00090233|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
1251154|NCT00090233|O1|Outcome|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
1251155|NCT00090233|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
1251156|NCT00090233|O1|Outcome|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
1251157|NCT00090233|O2|Outcome|Placebo|The number of participants randomized to treatment with Placebo is different from the number analyzed because some participants were excluded due to protocol violations and/or participants without follow-up and/or participants classified as unevaluable due to detection of wildtype rotavirus in the stool prior to 14 days Postdose 3; incomplete clinical and/or laboratory results; or stool samples collected out of day range.
1251158|NCT00090233|O1|Outcome|RotaTeq™|The number of participants randomized to treatment with RotaTeq™ is different from the number analyzed because some participants were excluded due to protocol violations and/or participants without follow-up and/or participants classified as unevaluable due to detection of wildtype rotavirus in the stool prior to 14 days Postdose 3; incomplete clinical and/or laboratory results; or stool samples collected out of day range.
1251159|NCT00090233|O2|Outcome|Placebo|Participants randomized to treatment with Placebo tested with data available for analysis excluding protocol violators, participants with invalid data based on laboratory determinations, participants with wildtype rotavirus detected in the stool, or with samples taken outside the range of 9 to 33 days postdose 3.
1251160|NCT00090233|O1|Outcome|RotaTeq™|Participants randomized to treatment with RotaTeq™ tested with data available for analysis excluding protocol violators, participants with invalid data based on laboratory determinations, participants with wildtype rotavirus detected in the stool, or with samples taken outside the range of 9 to 33 days postdose 3.
1251161|NCT00090233|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
1251287|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
1251162|NCT00090233|O1|Outcome|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
1251163|NCT00090233|E2|Reported Event|Placebo|"Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.~The Not Completed total includes participants discontinued at any time before the completion of the third study vaccination and/or the 42-day safety follow-up period post vaccination 3."
1251164|NCT00090233|E1|Reported Event|RotaTeq™|"Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.~The Not Completed total includes participants discontinued at any time before the completion of the third study vaccination and/or the 42-day safety follow-up period post vaccination 3."
1251165|NCT00090220|B3|Baseline|Total|Total of all reporting groups
1251166|NCT00090220|B2|Baseline|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
1251167|NCT00090220|B1|Baseline|qHPV Vaccine in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251168|NCT00090220|P6|Participant Flow|Placebo in Base Study and qHPV Vaccine in EXT1: LTFU (EXT2)|Participants at sites in Colombia who received placebo or an incomplete regimen of qHPV in the Base Study and open-label qHPV in EXT1 were followed from approximately Month 72 up to Month 120 (Year 10) after Day 1 in the Base Study.
1251210|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251169|NCT00090220|P5|Participant Flow|qHPV Vaccine in Base Study: LTFU (EXT2)|Participants at sites in Colombia who received qHPV vaccination in the Base Study were followed from approximately Month 72 up to Month 120 (Year 10) after Day 1 in the Base Study
1251170|NCT00090220|P4|Participant Flow|Incomplete qHPV Regimen in Base Study: EXT1|Participants who received an incomplete regimen of qHPV in the Base Study were offered open-label qHPV vaccine beginning at EXT1 Day 1 (approximately 60 months after Day 1 of the Base Study) and were followed to EXT1 Month 7 (approximately 67 months after Day 1 of the Base Study)
1251171|NCT00090220|P3|Participant Flow|Placebo in Base Study: EXT1|Participants who received placebo in the Base Study were offered open-label qHPV vaccine at EXT1 Day 1 (approximately 60 months after Day 1 of the Base Study), Month 2, and Month 6 and were followed to EXT1 Month 7 (approximately 67 months after Day 1 of the Base Study)
1251172|NCT00090220|P2|Participant Flow|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6
1251173|NCT00090220|P1|Participant Flow|qHPV Vaccine in Base Study|Participants received Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (qHPV, Gardasil) at Day 1, Month 2, and Month 6
1251174|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251175|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251176|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
1251177|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251178|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251179|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251180|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
1251181|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251182|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 and were followed to Month 48 in the Base Study
1251183|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251184|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 and were followed to Month 48 in the Base Study
1251185|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251186|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251187|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251188|NCT00090220|O2|Outcome|Placebo in the Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
1251189|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251190|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251191|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251192|NCT00090220|O2|Outcome|Placebo in the Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
1251193|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251194|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 and were followed to Month 48 in the Base Study
1251195|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251196|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251197|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251198|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251199|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251288|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
1251200|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251201|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251202|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251203|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251204|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251205|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251206|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251207|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251208|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251209|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1252231|NCT00087555|B1|Baseline|Placebo|Placebo taken as two equally divided nightly doses
1251211|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251212|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251213|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251214|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251215|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251216|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251217|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251218|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251219|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251220|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251221|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251222|NCT00090220|O1|Outcome|qHPV in Base Study: Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251223|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251224|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251225|NCT00090220|O1|Outcome|qHPV in Base Study: Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251226|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251227|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 35 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251228|NCT00090220|O1|Outcome|qHPV in Base Study: Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251229|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251230|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251231|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251232|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251233|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251234|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251235|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251236|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251237|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251238|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251289|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
1251239|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251240|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251241|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251242|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251243|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251244|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251245|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251246|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
1251247|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251248|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251249|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251250|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
1251251|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251252|NCT00090220|O2|Outcome|Base Study: Placebo|Participants who received placebo or an incomplete qHPV regimen in the Base Study and were offered open-label qHPV vaccine starting at approximately Month 60 in EXT1
1251253|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251254|NCT00090220|O2|Outcome|Placebo in Base Study|Participants who received placebo or an incomplete qHPV regimen in the Base Study and were offered open-label qHPV vaccine starting at approximately Month 60 in EXT1
1251255|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251256|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 and were followed to Month 48 in the Base Study
1251257|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251258|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
1251259|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
1251260|NCT00090220|E4|Reported Event|Long-term Follow-up: EXT2|Participants at sites in Colombia who received qHPV vaccination in the Base Study or in EXT1 were followed from Month 72 up to approximately Month 120 in LTFU (EXT2)
1251261|NCT00090220|E3|Reported Event|qHPV Vaccine: EXT1|Participants who received placebo or an incomplete regimen of qHPV in the Base Study were offered open-label qHPV vaccine starting at approximately Month 60 (EXT1) and were followed up to Month 67
1251262|NCT00090220|E2|Reported Event|Placebo: Base Study|Participants received placebo at Day 1, Month 2, and Month 6 and were followed up to approximately Month 48
1251263|NCT00090220|E1|Reported Event|qHPV Vaccine: Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 and were followed up to approximately Month 48
1251264|NCT00090142|B1|Baseline|Overall Study Population|All randomized patients
1251265|NCT00090142|P2|Participant Flow|Placebo in Period I Then Montelukast 10 mg in Period II|"A montelukast matching-image placebo tablet (Treatment Period I) was taken~orally in the morning as a single witnessed dose. This was followed by a 3-7 day washout and then a~montelukast 10-mg tablet (Treatment Period II) was taken orally in the morning as a single witnessed dose."
1251266|NCT00090142|P1|Participant Flow|Montelukast 10 mg in Period I Then Placebo in Period II|"A montelukast 10-mg tablet (Treatment Period I) was taken orally in the~morning as a single witnessed dose. This was followed by a 3-7 day washout period and then a montelukast~matching-image placebo tablet (Treatment Period II) was taken orally in the morning as a single witnessed~dose."
1251267|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
1251268|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
1251269|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
1251270|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
1251271|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
1251272|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
1251273|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
1251274|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
1251275|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
1251276|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
1251277|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
1251278|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
1251279|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
1251280|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
1251281|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
1251282|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
1251283|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
1251284|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
1251285|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
1251290|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
1251291|NCT00090142|E2|Reported Event|Placebo|
1251292|NCT00090142|E1|Reported Event|Montelukast 10 mg|
1251293|NCT00090103|B4|Baseline|Total|Total of all reporting groups
1251294|NCT00090103|B3|Baseline|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
1251295|NCT00090103|B2|Baseline|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
1251296|NCT00090103|B1|Baseline|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
1251297|NCT00090103|P3|Participant Flow|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
1251298|NCT00090103|P2|Participant Flow|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
1251299|NCT00090103|P1|Participant Flow|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
1251300|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
1251301|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
1251997|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
1251302|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
1251303|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
1251304|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
1251305|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
1251306|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
1251307|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
1251308|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
1251309|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
1251310|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
1251311|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
1251312|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
1251313|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
1251314|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
1251315|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
1251316|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
1251317|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
1251318|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
1251319|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
1251320|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
1251321|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
1251322|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
1251323|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
1251324|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
1251325|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
1251326|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
1251327|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
1251328|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
1251329|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
1251330|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
1251331|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
1251332|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
1251333|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
1251334|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
1251335|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
1251336|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
1251337|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
1251338|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
1251339|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
1251340|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
1251546|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
1251341|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
1251342|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
1251343|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
1251344|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
1251345|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
1251346|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
1251347|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
1251348|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
1251349|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
1251350|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
1251351|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
1251352|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
1251353|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
1251354|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
1251355|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
1251356|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
1251357|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
1251358|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
1251359|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
1251360|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
1251361|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
1251362|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
1251363|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
1251364|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
1251365|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
1251366|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
1251367|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
1251368|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
1251369|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
1251370|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
1251371|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
1251372|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
1251373|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
1251374|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
1251375|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
1251376|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
1251377|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
1251378|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
1251379|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
1251380|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
1251381|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
1251382|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
1251383|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
1251384|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
1251385|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
1251386|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
1251387|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
1251388|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
1251389|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
1251390|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
1251391|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
1251392|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
1251393|NCT00090103|E3|Reported Event|Tamsulosin 0.4 mg|
1251394|NCT00090103|E2|Reported Event|Dutasteride 0.5 mg|
1251395|NCT00090103|E1|Reported Event|Combination|
1251396|NCT00090051|B3|Baseline|Total|Total of all reporting groups
1251397|NCT00090051|B2|Baseline|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
1251398|NCT00090051|B1|Baseline|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
1251399|NCT00090051|P2|Participant Flow|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
1251495|NCT00089843|P3|Participant Flow|Active Actonel and Placebo Testosterone|Active Actonel tablet (35 mg weekly) and Placebo Testosterone Patch
1251400|NCT00090051|P1|Participant Flow|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
1251401|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
1251402|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
1251403|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
1251404|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
1251405|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
1251406|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
1251407|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
1251408|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
1251409|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
1251410|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
1251411|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
1251412|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
1251413|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
1251414|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
1251479|NCT00089895|B2|Baseline|Placebo|Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
1251547|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
1251415|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
1251416|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
1251417|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
1251418|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
1251419|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
1251581|NCT00089648|B1|Baseline|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
1251420|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
1251421|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
1251422|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
1251423|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
1251424|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
1251425|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
1251426|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
1251427|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
1251428|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
1251429|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
1251430|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
1251431|NCT00090051|E2|Reported Event|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
1251432|NCT00090051|E1|Reported Event|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
1251433|NCT00089999|B3|Baseline|Total|Total of all reporting groups
1251434|NCT00089999|B2|Baseline|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
1251480|NCT00089895|B1|Baseline|Eptifibatide|Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
1251435|NCT00089999|B1|Baseline|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
1251436|NCT00089999|P2|Participant Flow|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally twice daily (BID). Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
1251437|NCT00089999|P1|Participant Flow|Lapatinib 1500 mg QD|Participants received lapatinib 1500 milligram (mg) orally once daily (QD). Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
1251438|NCT00089999|O2|Outcome|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
1251439|NCT00089999|O1|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
1251582|NCT00089648|P1|Participant Flow|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
1251440|NCT00089999|O2|Outcome|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
1251441|NCT00089999|O1|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
1251442|NCT00089999|O2|Outcome|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
1251443|NCT00089999|O1|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
1251444|NCT00089999|O2|Outcome|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
1251445|NCT00089999|O1|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
1251446|NCT00089999|O2|Outcome|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
1251447|NCT00089999|O1|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
1251448|NCT00089999|O2|Outcome|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
1251449|NCT00089999|O1|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
1251450|NCT00089999|O2|Outcome|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
1251481|NCT00089895|P2|Participant Flow|Placebo|Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
1251451|NCT00089999|O1|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
1251452|NCT00089999|O2|Outcome|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
1251453|NCT00089999|O1|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
1251454|NCT00089999|E2|Reported Event|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
1251455|NCT00089999|E1|Reported Event|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
1251456|NCT00089986|B4|Baseline|Total|Total of all reporting groups
1251496|NCT00089843|P2|Participant Flow|Active Actonel and Active Testosterone Patch|Active Actonel tablet (35 mg weekly) and Active Testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
1252074|NCT00087685|O1|Outcome|RAD001|10 mg orally daily/28-day cycles
1251457|NCT00089986|B3|Baseline|High GR270773|Eligible participants were administered high-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The high dose emulsion consisted of a loading dose of 15 mg/kg/h which was equivalent to 1.5 mL/kg/h for 2 h and a maintenance dose of 15 mg/kg/h which was equivalent to 0.15 mL/kg/h for 70 h. The total dose was 1350 mg/kg.
1251458|NCT00089986|B2|Baseline|Low GR270773|Eligible participants were administered low-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The low dose emulsion consisted of a loading dose of 75 mg/kg/h which was equivalent to 0.75 mL/kg/h for 2 h and a maintenance dose of 10 mg/kg/h which was equivalent to 0.1 mL/kg/h for 70 h. The total dose was 850 mg/kg.
1251459|NCT00089986|B1|Baseline|Placebo|Eligible participants were administered matching placebo to low-dose GR270773 or high-dose GR270773, IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The low placebo rate consisted of a loading dose of 0.75 mL/kg/h for 2 h and a maintenance dose of 0.1 mL/kg/h for 70 h. The high placebo rate consisted of a loading dose of 1.5 mL/kg/h for 2 h and a maintenance dose of 0.15 mL/kg/h for 70 h.
1251460|NCT00089986|P3|Participant Flow|High GR270773|Eligible participants were administered high-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The high dose emulsion consisted of a loading dose of 15 mg/kg/h which was equivalent to 1.5 mL/kg/h for 2 h and a maintenance dose of 15 mg/kg/h which was equivalent to 0.15 mL/kg/h for 70 h. The total dose was 1350 mg/kg.
1251461|NCT00089986|P2|Participant Flow|Low GR270773|Eligible participants were administered low-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 milligrams per milliliter (mg/mL) lipid emulsion for IV administration. The low dose emulsion consisted of a loading dose of 75 milligram (mg)/kg/h which was equivalent to 0.75 mL/kg/h for 2 h and a maintenance dose of 10 mg/kg/h which was equivalent to 0.1 mL/kg/h for 70 h. The total dose was 850 mg/kg.
1251462|NCT00089986|P1|Participant Flow|Placebo|Eligible participants were administered matching placebo to low-dose GR270773 or high-dose GR270773, intravenously (IV) as a loading dose infused over 2 hours (h) followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The low placebo rate consisted of a loading dose of 0.75 milliliters per kilogram per hour (mL/kg/h) for 2 h and a maintenance dose of 0.1 mL/kg/h for 70 h. The high placebo rate consisted of a loading dose of 1.5 mL/kg/h for 2 h and a maintenance dose of 0.15 mL/kg/h for 70 h.
1251463|NCT00089986|O3|Outcome|High GR270773|Eligible participants were administered high-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The high dose emulsion consisted of a loading dose of 15 mg/kg/h which was equivalent to 1.5 mL/kg/h for 2 h and a maintenance dose of 15 mg/kg/h which was equivalent to 0.15 mL/kg/h for 70 h. The total dose was 1350 mg/kg.
1251464|NCT00089986|O2|Outcome|Low GR270773|Eligible participants were administered low-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The low dose emulsion consisted of a loading dose of 75 mg/kg/h which was equivalent to 0.75 mL/kg/h for 2 h and a maintenance dose of 10 mg/kg/h which was equivalent to 0.1 mL/kg/h for 70 h. The total dose was 850 mg/kg.
1251482|NCT00089895|P1|Participant Flow|Eptifibatide|Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
1251483|NCT00089895|O2|Outcome|Placebo|Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
1251465|NCT00089986|O1|Outcome|Placebo|Eligible participants were administered matching placebo to low-dose GR270773 or high-dose GR270773, IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The low placebo rate consisted of a loading dose of 0.75 mL/kg/h for 2 h and a maintenance dose of 0.1 mL/kg/h for 70 h. The high placebo rate consisted of a loading dose of 1.5 mL/kg/h for 2 h and a maintenance dose of 0.15 mL/kg/h for 70 h.
1251466|NCT00089986|O3|Outcome|High GR270773|Eligible participants were administered high-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The high dose emulsion consisted of a loading dose of 15 mg/kg/h which was equivalent to 1.5 mL/kg/h for 2 h and a maintenance dose of 15 mg/kg/h which was equivalent to 0.15 mL/kg/h for 70 h. The total dose was 1350 mg/kg.
1251467|NCT00089986|O2|Outcome|Low GR270773|Eligible participants were administered low-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The low dose emulsion consisted of a loading dose of 75 mg/kg/h which was equivalent to 0.75 mL/kg/h for 2 h and a maintenance dose of 10 mg/kg/h which was equivalent to 0.1 mL/kg/h for 70 h. The total dose was 850 mg/kg.
1251468|NCT00089986|O1|Outcome|Placebo|Eligible participants were administered matching placebo to low-dose GR270773 or high-dose GR270773, IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The low placebo rate consisted of a loading dose of 0.75 mL/kg/h for 2 h and a maintenance dose of 0.1 mL/kg/h for 70 h. The high placebo rate consisted of a loading dose of 1.5 mL/kg/h for 2 h and a maintenance dose of 0.15 mL/kg/h for 70 h.
1251469|NCT00089986|O3|Outcome|High GR270773|Eligible participants were administered high-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The high dose emulsion consisted of a loading dose of 15 mg/kg/h which was equivalent to 1.5 mL/kg/h for 2 h and a maintenance dose of 15 mg/kg/h which was equivalent to 0.15 mL/kg/h for 70 h. The total dose was 1350 mg/kg.
1251564|NCT00089661|B1|Baseline|Denosumab 60 mg Q6M|
1251565|NCT00089661|P2|Participant Flow|Placebo|
1251566|NCT00089661|P1|Participant Flow|Denosumab 60 mg Q6M|
1251470|NCT00089986|O2|Outcome|Low GR270773|Eligible participants were administered low-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The low dose emulsion consisted of a loading dose of 75 mg/kg/h which was equivalent to 0.75 mL/kg/h for 2 h and a maintenance dose of 10 mg/kg/h which was equivalent to 0.1 mL/kg/h for 70 h. The total dose was 850 mg/kg.
1251471|NCT00089986|O1|Outcome|Placebo|Eligible participants were administered matching placebo to low-dose GR270773 or high-dose GR270773, IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The low placebo rate consisted of a loading dose of 0.75 mL/kg/h for 2 h and a maintenance dose of 0.1 mL/kg/h for 70 h. The high placebo rate consisted of a loading dose of 1.5 mL/kg/h for 2 h and a maintenance dose of 0.15 mL/kg/h for 70 h.
1251472|NCT00089986|O3|Outcome|High GR270773|Eligible participants were administered high-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The high dose emulsion consisted of a loading dose of 15 mg/kg/h which was equivalent to 1.5 mL/kg/h for 2 h and a maintenance dose of 15 mg/kg/h which was equivalent to 0.15 mL/kg/h for 70 h. The total dose was 1350 mg/kg.
1251473|NCT00089986|O2|Outcome|Low GR270773|Eligible participants were administered low-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The low dose emulsion consisted of a loading dose of 75 mg/kg/h which was equivalent to 0.75 mL/kg/h for 2 h and a maintenance dose of 10 mg/kg/h which was equivalent to 0.1 mL/kg/h for 70 h. The total dose was 850 mg/kg.
1251474|NCT00089986|O1|Outcome|Placebo|Eligible participants were administered matching placebo to low-dose GR270773 or high-dose GR270773, IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The low placebo rate consisted of a loading dose of 0.75 mL/kg/h for 2 h and a maintenance dose of 0.1 mL/kg/h for 70 h. The high placebo rate consisted of a loading dose of 1.5 mL/kg/h for 2 h and a maintenance dose of 0.15 mL/kg/h for 70 h.
1251475|NCT00089986|E3|Reported Event|High GR270773|Eligible participants were administered high-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The high dose emulsion consisted of a loading dose of 15 mg/kg/h which was equivalent to 1.5 mL/kg/h for 2 h and a maintenance dose of 15 mg/kg/h which was equivalent to 0.15 mL/kg/h for 70 h. The total dose was 1350 mg/kg.
1251476|NCT00089986|E2|Reported Event|Low GR270773|Eligible participants were administered low-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The low dose emulsion consisted of a loading dose of 75 mg/kg/h which was equivalent to 0.75 mL/kg/h for 2 h and a maintenance dose of 10 mg/kg/h which was equivalent to 0.1 mL/kg/h for 70 h. The total dose was 850 mg/kg.
1251477|NCT00089986|E1|Reported Event|Placebo|Eligible participants were administered matching placebo to low-dose GR270773 or high-dose GR270773, IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The low placebo rate consisted of a loading dose of 0.75 mL/kg/h for 2 h and a maintenance dose of 0.1 mL/kg/h for 70 h. The high placebo rate consisted of a loading dose of 1.5 mL/kg/h for 2 h and a maintenance dose of 0.15 mL/kg/h for 70 h.
1251478|NCT00089895|B3|Baseline|Total|Total of all reporting groups
1251484|NCT00089895|O1|Outcome|Eptifibatide|Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
1251485|NCT00089895|O2|Outcome|Placebo|Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
1251486|NCT00089895|O1|Outcome|Eptifibatide|Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
1251487|NCT00089895|E2|Reported Event|Placebo|Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
1251488|NCT00089895|E1|Reported Event|Eptifibatide|Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
1251489|NCT00089843|B5|Baseline|Total|Total of all reporting groups
1251490|NCT00089843|B4|Baseline|Placebo Testosterone Patch and Placebo Actonel|Placebo Testosterone Patch and placebo Actonel tablet
1251491|NCT00089843|B3|Baseline|Active Actonel and Placebo Testosterone|Active Actonel tablet (35 mg weekly) and Placebo Testosterone Patch
1251492|NCT00089843|B2|Baseline|Active Actonel and Active Testosterone Patch|Active Actonel tablet (35 mg weekly) and Active Testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
1251493|NCT00089843|B1|Baseline|Placebo Actonel and Active Testosterone Patch|Placebo Actonel tablet weekly and active testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
1251494|NCT00089843|P4|Participant Flow|Placebo Testosterone Patch and Placebo Actonel|Placebo Testosterone Patch and placebo Actonel tablet
1251497|NCT00089843|P1|Participant Flow|Placebo Actonel and Active Testosterone Patch|Placebo Actonel tablet weekly and active testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
1251498|NCT00089843|O2|Outcome|Testosterone|Testosterone patch(starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
1251499|NCT00089843|O1|Outcome|Actonel (Risedronate)|Actonel (risedronate) 35 mg tablet weekly
1251500|NCT00089843|O2|Outcome|Testosterone|Testosterone, initial dose 150 mcg transdermal daily, increased to 300 mcg daily in women with free testosterone levels below the median (n=25 women)
1251501|NCT00089843|O1|Outcome|Actonel (Risedronate) 35 mg Weekly|Actonel (risedronate) 35 mg, 1 tablet weekly
1251502|NCT00089843|E4|Reported Event|Placebo Testosterone Patch and Placebo Actonel|Placebo Testosterone Patch and placebo Actonel tablet
1251503|NCT00089843|E3|Reported Event|Active Actonel and Placebo Testosterone|Active Actonel tablet (35 mg weekly) and Placebo Testosterone Patch
1251504|NCT00089843|E2|Reported Event|Active Actonel and Active Testosterone Patch|Active Actonel tablet (35 mg weekly) and Active Testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
1251505|NCT00089843|E1|Reported Event|Placebo Actonel and Active Testosterone Patch|Placebo Actonel tablet weekly and active testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
1251506|NCT00089791|B3|Baseline|Total|Total of all reporting groups
1251507|NCT00089791|B2|Baseline|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
1251508|NCT00089791|B1|Baseline|Placebo|Placebo administered subcutaneously once every 6 months for 3 years.
1251509|NCT00089791|P2|Participant Flow|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
1251510|NCT00089791|P1|Participant Flow|Placebo|Placebo administered subcutaneously once every 6 months for 3 years.
1251511|NCT00089791|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
1251512|NCT00089791|O1|Outcome|Placebo|Placebo administered subcutaneously once every 6 months for 3 years.
1251513|NCT00089791|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
1251514|NCT00089791|O1|Outcome|Placebo|Placebo administered subcutaneously once every 6 months for 3 years.
1251515|NCT00089791|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
1251516|NCT00089791|O1|Outcome|Placebo|Placebo administered subcutaneously once every 6 months for 3 years.
1251517|NCT00089791|E2|Reported Event|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
1251518|NCT00089791|E1|Reported Event|Placebo|Placebo administered subcutaneously once every 6 months for 3 years.
1251519|NCT00089778|B4|Baseline|Total|Total of all reporting groups
1251520|NCT00089778|B3|Baseline|Grp C - High-risk Loco-regional Disease|"Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy.~A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant)"
1251521|NCT00089778|B2|Baseline|Grp B - Measurable Metastatic Disease That Require Aldesleukin|"Patients who require immediate treatment with IL-2. A2 FGF-5: 117-126 peptide + HD (high dose) IL-2 (prior cycle 1) Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.~720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses)."
1251522|NCT00089778|B1|Baseline|Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)|"Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy.~A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other."
1251542|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
1251543|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
1251544|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
1251545|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
1251523|NCT00089778|P3|Participant Flow|Grp C - High-risk Loco-regional Disease|"Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy.~A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant).~This is not a conventional crossover—If a patient in Group C has a recurrence after vaccination or cancer progresses in Group A, then we wanted to administer an approved, conventional therapy for recurrent disease (IL-2) which could have had synergy with the prior experimental vaccination. This was only exploratory and there was no specific endpoint targeted in patient’s crossing over and there was no impact on study size (too involved for the scope of this study)."
1251524|NCT00089778|P2|Participant Flow|Grp B - Measurable Metastatic Disease That Require Aldesleukin|"Patients who require immediate treatment with IL-2. A2 FGF-5: 117-126 peptide + HD (high dose) IL-2 (prior cycle 1) Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.~720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses).~This is not a conventional crossover—If a patient in Group C has a recurrence after vaccination or cancer progresses in Group A, then we wanted to administer an approved, conventional therapy for recurrent disease (IL-2) which could have had synergy with the prior experimental vaccination. This was only exploratory and there was no specific endpoint targeted in patient’s crossing over and there was no impact on study size (too involved for the scope of this study)."
1251525|NCT00089778|P1|Participant Flow|Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)|"Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy.~A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other.~This is not a conventional crossover—If a patient in Group C has a recurrence after vaccination or cancer progresses in Group A, then we wanted to administer an approved, conventional therapy for recurrent disease (IL-2) which could have had synergy with the prior experimental vaccination. This was only exploratory and there was no specific endpoint targeted in patient’s crossing over and there was no impact on study size (too involved for the scope of this study)."
1251567|NCT00089661|O2|Outcome|Placebo|
1251568|NCT00089661|O1|Outcome|Denosumab 60 mg Q6M|
1251569|NCT00089661|O2|Outcome|Placebo|
1251526|NCT00089778|O1|Outcome|Grp C - High-risk Loco-regional Disease|"Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy.~A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant)"
1251527|NCT00089778|O3|Outcome|Grp C - High-risk Loco-regional Disease|"Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy.~A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant)"
1251528|NCT00089778|O2|Outcome|Grp B - Measurable Metastatic Disease That Require Aldesleukin|"Patients who require immediate treatment with IL-2. A2 FGF-5: 117-126 peptide + HD (high dose) IL-2 (prior cycle 1) Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.~720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses)."
1251529|NCT00089778|O1|Outcome|Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)|"Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy.~A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other."
1251530|NCT00089778|O2|Outcome|Grp B - Measurable Metastatic Disease That Require Aldesleukin|"Patients who require immediate treatment with IL-2. A2 FGF-5: 117-126 peptide + HD (high dose) IL-2 (prior cycle 1) Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.~720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses)."
1251531|NCT00089778|O1|Outcome|Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)|"Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy.~A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other.~Because patients in Group C had no evaluable disease, response evaluation was not an appropriate endpoint. The purpose of putting such patients in the trial was they were more likely to survive long enough to complete the full sequence of intended vaccinations and permit an immunological/laboratory endpoint evaluation (not as likely for Groups A and B)."
1251532|NCT00089778|E3|Reported Event|Grp C - High-risk Loco-regional Disease|"Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy.~A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant)"
1251533|NCT00089778|E2|Reported Event|Grp B - Measurable Metastatic Disease That Require Aldesleukin|"Patients who require immediate treatment with IL-2. A2 FGF-5: 117-126 peptide + HD (high dose) IL-2 (prior cycle 1) Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.~720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses)."
1251534|NCT00089778|E1|Reported Event|Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)|"Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy.~A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other."
1251535|NCT00089674|B3|Baseline|Total|Total of all reporting groups
1251536|NCT00089674|B2|Baseline|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
1251537|NCT00089674|B1|Baseline|Placebo|Placebo administered subcutaneous every 6 months for 3 years
1251538|NCT00089674|P2|Participant Flow|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
1251539|NCT00089674|P1|Participant Flow|Placebo|Placebo administered subcutaneous every 6 months for 3 years
1251540|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
1251541|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
1251548|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
1251549|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
1251550|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
1251551|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
1251552|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
1251553|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
1251554|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
1251555|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
1251556|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
1251557|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
1251558|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
1251559|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
1251560|NCT00089674|E2|Reported Event|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
1251561|NCT00089674|E1|Reported Event|Placebo|Placebo administered subcutaneous every 6 months for 3 years
1251562|NCT00089661|B3|Baseline|Total|Total of all reporting groups
1251563|NCT00089661|B2|Baseline|Placebo|
1251583|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
1251584|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
1251585|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
1251586|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
1251587|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
1251588|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
1251589|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
1251590|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
1251591|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
1251592|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
1251593|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
1251594|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
1251595|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
1251596|NCT00089648|E1|Reported Event|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
1251597|NCT00089635|B1|Baseline|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
1251598|NCT00089635|P1|Participant Flow|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
1251599|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
1251600|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
1251601|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
1251602|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
1251603|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
1251604|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
1251605|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
1251606|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
1251607|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
1251608|NCT00089635|E1|Reported Event|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
1251609|NCT00089609|B3|Baseline|Total|Total of all reporting groups
1251610|NCT00089609|B2|Baseline|Expansion Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added
1251611|NCT00089609|B1|Baseline|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
1251612|NCT00089609|P2|Participant Flow|Expansion Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added.
1251613|NCT00089609|P1|Participant Flow|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
1251614|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
1252075|NCT00087685|O1|Outcome|RAD001|10 mg orally daily/28-day cycles
1251615|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
1251616|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
1251617|NCT00089609|O2|Outcome|Main Cohort - Particpants With <75% PSA Decline|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
1251618|NCT00089609|O1|Outcome|Main Cohort - Particpants With ≥75% PSA Decline|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
1251619|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
1251620|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
1251621|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
1251622|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
1251623|NCT00089609|O2|Outcome|Expansion Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added.
1251624|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
1251625|NCT00089609|O1|Outcome|Expansion Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added
1251626|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
1251627|NCT00089609|E2|Reported Event|Expansion Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added
1251628|NCT00089609|E1|Reported Event|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
1251629|NCT00089583|B3|Baseline|Total|Total of all reporting groups
1251630|NCT00089583|B2|Baseline|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251631|NCT00089583|B1|Baseline|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251632|NCT00089583|P2|Participant Flow|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251633|NCT00089583|P1|Participant Flow|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251808|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
1251634|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251635|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251636|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251637|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251638|NCT00089583|O4|Outcome|PI-experienced, ART-experienced FPV/RTV Treatment Group|HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
1251639|NCT00089583|O3|Outcome|PI Naïve, ART-experienced, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-experienced but PI- pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
1251640|NCT00089583|O2|Outcome|ART-Naïve, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
1251641|NCT00089583|O1|Outcome|ART-Naïve, FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, antiretroviral-naive pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID)
1251642|NCT00089583|O4|Outcome|PI-experienced, ART-experienced FPV/RTV Treatment Group|HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
1251643|NCT00089583|O3|Outcome|PI Naïve, ART-experienced, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-experienced but PI- pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
1251644|NCT00089583|O2|Outcome|ART-Naïve, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
1251645|NCT00089583|O1|Outcome|ART-Naïve, FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, antiretroviral-naive pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID)
1251646|NCT00089583|O4|Outcome|PI Experienced, ART Experienced, FPV/RTV Treatment Group|HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
1251647|NCT00089583|O3|Outcome|PI Naïve, ART Experienced, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
1251648|NCT00089583|O2|Outcome|ART-Naïve, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
1251649|NCT00089583|O1|Outcome|ART-Naïve, FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, antiretroviral-naive pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID)
1253273|NCT00083174|E1|Reported Event|Exemestane|one 25 mg tablet daily in am
1251650|NCT00089583|O4|Outcome|PI Experienced, ART Experienced, FPV/RTV Treatment Group|HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
1251651|NCT00089583|O3|Outcome|PI Naïve, ART Experienced, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
1251652|NCT00089583|O2|Outcome|ART-Naïve, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
1251653|NCT00089583|O1|Outcome|ART-Naïve, FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, antiretroviral-naive pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID)
1251654|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251809|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
1251655|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251656|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251657|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251658|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251659|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251660|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251661|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251662|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251791|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
1253274|NCT00083122|B3|Baseline|Total|Total of all reporting groups
1251663|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251664|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251665|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251677|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251810|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
1251666|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251667|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251668|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251669|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251670|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251671|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251672|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251673|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251674|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251675|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251676|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251811|NCT00089479|E2|Reported Event|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
1251678|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251679|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251680|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251681|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251682|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251683|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251684|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251685|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251686|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251687|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251688|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251812|NCT00089479|E1|Reported Event|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
1251813|NCT00089414|B4|Baseline|Total|Total of all reporting groups
1251689|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251690|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251691|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251692|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251693|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251694|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251695|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251696|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251697|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251698|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251699|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251711|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251905|NCT00088972|P2|Participant Flow|Arm II|Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
1251700|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251701|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251702|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251703|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251704|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251705|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251706|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251707|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251708|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251709|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251710|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251803|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
1251712|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251713|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251714|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251715|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251716|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251717|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251718|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251719|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251720|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251721|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251722|NCT00089583|E2|Reported Event|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
1251804|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
1251906|NCT00088972|P1|Participant Flow|Arm I|Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
1251723|NCT00089583|E1|Reported Event|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
1251724|NCT00089544|B3|Baseline|Total|Total of all reporting groups
1251725|NCT00089544|B2|Baseline|Cohort B (Thalidomide, Radiation, Surgery)|Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
1251726|NCT00089544|B1|Baseline|Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery)|Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.
1251727|NCT00089544|P2|Participant Flow|Cohort B (Thalidomide, Radiation, Surgery)|Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
1251728|NCT00089544|P1|Participant Flow|Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery)|Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.
1251729|NCT00089544|O2|Outcome|Cohort B (Thalidomide, Radiation, Surgery)|Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
1251730|NCT00089544|O1|Outcome|Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery)|Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.
1251731|NCT00089544|O2|Outcome|Cohort B (Thalidomide, Radiation, Surgery)|Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
1251732|NCT00089544|O1|Outcome|Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery)|Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.
1251976|NCT00088530|O2|Outcome|Comparator Group|Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
1251733|NCT00089544|O2|Outcome|Cohort B (Thalidomide, Radiation, Surgery)|Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
1251734|NCT00089544|O1|Outcome|Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery)|Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.
1251735|NCT00089544|E2|Reported Event|Cohort B (Thalidomide, Radiation, Surgery)|Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
1251736|NCT00089544|E1|Reported Event|Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery)|Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.
1251737|NCT00089505|B5|Baseline|Total|Total of all reporting groups
1251805|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
1251738|NCT00089505|B4|Baseline|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
1251739|NCT00089505|B3|Baseline|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
1251740|NCT00089505|B2|Baseline|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
1251741|NCT00089505|B1|Baseline|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
1251742|NCT00089505|P4|Participant Flow|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
1251743|NCT00089505|P3|Participant Flow|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
1251744|NCT00089505|P2|Participant Flow|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
1251745|NCT00089505|P1|Participant Flow|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
1251746|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
1251792|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
1251977|NCT00088530|O1|Outcome|Experimental Group|Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle
1251747|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
1251748|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
1251749|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
1251750|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
1251751|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
1251806|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
1251907|NCT00088972|O2|Outcome|Arm II|Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
1251752|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
1251753|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
1251754|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
1251755|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
1251756|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
1251757|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
1251758|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
1251759|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
1251774|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
1251760|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
1251761|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
1251762|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
1251763|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
1251764|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
1251765|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
1251766|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
1251767|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
1251768|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
1251769|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
1251770|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
1251771|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
1251772|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
1251773|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
1251775|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
1251776|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
1251777|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
1251778|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
1251779|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
1251807|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
1252076|NCT00087685|E1|Reported Event|RAD001|10 mg orally daily/28-day cycles
1251780|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
1251781|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
1251782|NCT00089505|E4|Reported Event|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
1251783|NCT00089505|E3|Reported Event|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
1251784|NCT00089505|E2|Reported Event|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
1251785|NCT00089505|E1|Reported Event|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
1251786|NCT00089479|B3|Baseline|Total|Total of all reporting groups
1251787|NCT00089479|B2|Baseline|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
1251788|NCT00089479|B1|Baseline|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
1251789|NCT00089479|P2|Participant Flow|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
1251790|NCT00089479|P1|Participant Flow|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
1251978|NCT00088530|O2|Outcome|Comparator Group|Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
1251793|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
1251794|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
1251795|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
1251796|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
1251797|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
1251798|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
1251799|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
1251800|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
1251801|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
1251802|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
1251814|NCT00089414|B3|Baseline|Continuous OC Plus PR Antagonist|Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 (extended EE/P with menses) is identical to treatment arm # 1 except the progesterone antagonist CDB-2914 will be administered during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. As such, menses will occur in these women at approximately the same interval as experienced by those women in treatment arm # 2 due to the local effects of the progesterone receptor antagonist on the endometrium (lining of the uterus). Thus, women in treatment arms # 3 and # 1 will be exposed to continuous levels of ethinyl estradiol and progestin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
1251815|NCT00089414|B2|Baseline|Interrupted OC|Treatment arm # 2 (interrupted EE/P administration) will be identical to arm # 1 with the exception that the continuous administration of EE/P will be interrupted by the substitution of placebo for EE/P for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after EE/P withdrawal (placebo).
1251816|NCT00089414|B1|Baseline|Continuous OCP Plus Placebo|Treatment arm # 1 (extended ethinyl estradiol and progestin [EE/P]) consists of the continuous administration of 30 µg of ethinyl estradiol and 3 mg of drospirenone (Yasmin) for 15 weeks starting on day 2 to 5 of the first menstrual cycle.
1251817|NCT00089414|P3|Participant Flow|Continuous Yasmin Plus Progesterone Antagonist|Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 is identical to treatment arm # 1 with the exception that the continuous administration of Yasmin will also include the administration of progesterone antagonist CDB-2914 during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. Women in treatment arms # 3 and # 1 will be exposed to continuous levels of Yasmin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
1251818|NCT00089414|P2|Participant Flow|Interrupted Yasmin|Treatment arm # 2 (interrupted Yasmin administration) will be identical to arm # 1 with the exception that the continuous administration of Yasmin will be interrupted by the substitution of placebo for Yasmin for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after Yasmin withdrawal (when they are on placebo).
1251819|NCT00089414|P1|Participant Flow|Continuous Yasmin|Treatment arm # 1 consists of the continuous administration of Yasmin oral contraceptive (a combination of 30 µg of ethinyl estradiol and 3 mg of drospirenone) for 15 weeks starting on day 2 to 5 of the first menstrual cycle.
1251820|NCT00089414|O3|Outcome|Continuous Yasmin Plus Progesterone Antagonist|Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 is identical to treatment arm # 1 with the exception that the continuous administration of Yasmin will also include the administration of progesterone antagonist CDB-2914 during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. Women in treatment arms # 3 and # 1 will be exposed to continuous levels of Yasmin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
1251821|NCT00089414|O2|Outcome|Interrupted Yasmin|Treatment arm # 2 (interrupted Yasmin administration) will be identical to arm # 1 with the exception that the continuous administration of Yasmin will be interrupted by the substitution of placebo for Yasmin for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after Yasmin withdrawal (when they are on placebo).
1251822|NCT00089414|O1|Outcome|Continuous Yasmin|Treatment arm # 1 consists of the continuous administration of Yasmin oral contraceptive (a combination of 30 µg of ethinyl estradiol and 3 mg of drospirenone) for 15 weeks starting on day 2 to 5 of the first menstrual cycle.
1251823|NCT00089414|O3|Outcome|Continuous Yasmin Plus Progesterone Antagonist|Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 is identical to treatment arm # 1 with the exception that the continuous administration of Yasmin will also include the administration of progesterone antagonist CDB-2914 during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. Women in treatment arms # 3 and # 1 will be exposed to continuous levels of Yasmin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
1254344|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
1251824|NCT00089414|O2|Outcome|Interrupted Yasmin|Treatment arm # 2 (interrupted Yasmin administration) will be identical to arm # 1 with the exception that the continuous administration of Yasmin will be interrupted by the substitution of placebo for Yasmin for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after Yasmin withdrawal (when they are on placebo).
1251825|NCT00089414|O1|Outcome|Continuous Yasmin|Treatment arm # 1 consists of the continuous administration of Yasmin oral contraceptive (a combination of 30 µg of ethinyl estradiol and 3 mg of drospirenone) for 15 weeks starting on day 2 to 5 of the first menstrual cycle.
1251826|NCT00089414|O3|Outcome|Continuous Yasmin Plus Progesterone Antagonist|Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 is identical to treatment arm # 1 with the exception that the continuous administration of Yasmin will also include the administration of progesterone antagonist CDB-2914 during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. Women in treatment arms # 3 and # 1 will be exposed to continuous levels of Yasmin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
1251827|NCT00089414|O2|Outcome|Interrupted Yasmin|Treatment arm # 2 (interrupted Yasmin administration) will be identical to arm # 1 with the exception that the continuous administration of Yasmin will be interrupted by the substitution of placebo for Yasmin for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after Yasmin withdrawal (when they are on placebo).
1251828|NCT00089414|O1|Outcome|Continuous Yasmin|Treatment arm # 1 consists of the continuous administration of Yasmin oral contraceptive (a combination of 30 µg of ethinyl estradiol and 3 mg of drospirenone) for 15 weeks starting on day 2 to 5 of the first menstrual cycle.
1251889|NCT00089011|O1|Outcome|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~fludarabine phosphate: Given IV~total-body irradiation: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies"
1251908|NCT00088972|O1|Outcome|Arm I|Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
1252077|NCT00087672|B1|Baseline|CC-5013|10 mg orally daily
1251829|NCT00089414|E3|Reported Event|Continuous OC Plus PR Antagonist|Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 (extended EE/P with menses) is identical to treatment arm # 1 except the progesterone antagonist CDB-2914 will be administered during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. As such, menses will occur in these women at approximately the same interval as experienced by those women in treatment arm # 2 due to the local effects of the progesterone receptor antagonist on the endometrium (lining of the uterus). Thus, women in treatment arms # 3 and # 1 will be exposed to continuous levels of ethinyl estradiol and progestin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
1251830|NCT00089414|E2|Reported Event|Interrupted OC|Treatment arm # 2 (interrupted EE/P administration) will be identical to arm # 1 with the exception that the continuous administration of EE/P will be interrupted by the substitution of placebo for EE/P for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after EE/P withdrawal (placebo).
1251831|NCT00089414|E1|Reported Event|Continuous OCP Plus Placebo|Treatment arm # 1 (extended ethinyl estradiol and progestin [EE/P]) consists of the continuous administration of 30 µg of ethinyl estradiol and 3 mg of drospirenone (Yasmin) for 15 weeks starting on day 2 to 5 of the first menstrual cycle.
1251832|NCT00089297|B1|Baseline|Cetuximab/Paclitaxel/Carboplatin|"Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.~Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).~Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.~Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks."
1251833|NCT00089297|P1|Participant Flow|Cetuximab/Paclitaxel/Carboplatin|"Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.~Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).~Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.~Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks."
1251834|NCT00089297|O1|Outcome|Cetuximab/Paclitaxel/Carboplatin|"Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.~Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).~Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.~Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks."
1251866|NCT00089076|O1|Outcome|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
1251979|NCT00088530|O1|Outcome|Experimental Group|Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle
1251835|NCT00089297|O1|Outcome|Cetuximab/Paclitaxel/Carboplatin|"Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.~Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).~Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.~Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks."
1251836|NCT00089297|O1|Outcome|Cetuximab/Paclitaxel/Carboplatin|"Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.~Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).~Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.~Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks."
1251837|NCT00089297|O1|Outcome|Cetuximab/Paclitaxel/Carboplatin|"Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.~Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).~Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.~Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks."
1251903|NCT00088972|B2|Baseline|Arm II|Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
1251838|NCT00089297|E1|Reported Event|Cetuximab/Paclitaxel/Carboplatin|"Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.~Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).~Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.~Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks."
1251839|NCT00089141|B3|Baseline|Total|Total of all reporting groups
1251840|NCT00089141|B2|Baseline|Placebo|Patients receive oral placebo twice daily
1251841|NCT00089141|B1|Baseline|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
1251842|NCT00089141|P2|Participant Flow|Placebo|Patients receive oral placebo twice daily
1251843|NCT00089141|P1|Participant Flow|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
1251844|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
1251845|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
1251846|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
1251847|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
1251848|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
1251849|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
1251850|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
1251851|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
1251852|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
1251853|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
1251854|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
1251855|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
1251856|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
1251857|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
1251858|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
1251859|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
1251860|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
1251861|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
1251862|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
1251863|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
1251864|NCT00089076|B1|Baseline|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
1251865|NCT00089076|P1|Participant Flow|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
1251867|NCT00089076|O1|Outcome|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
1251868|NCT00089076|O1|Outcome|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
1251869|NCT00089076|O1|Outcome|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
1251870|NCT00089076|O1|Outcome|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
1251871|NCT00089076|O1|Outcome|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
1251872|NCT00089076|O1|Outcome|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
1251873|NCT00089076|O1|Outcome|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
1251874|NCT00089076|E1|Reported Event|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
1251875|NCT00089011|B3|Baseline|Total|Total of all reporting groups
1251904|NCT00088972|B1|Baseline|Arm I|Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
1251995|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
1251876|NCT00089011|B2|Baseline|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.~total-body irradiation: Undergo radiotherapy~mycophenolate mofetil: Given IV or PO~tacrolimus: Given IV or PO~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~laboratory biomarker analysis: Correlative studies"
1251877|NCT00089011|B1|Baseline|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~fludarabine phosphate: Given IV~total-body irradiation: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies"
1251878|NCT00089011|P2|Participant Flow|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.~total-body irradiation: Undergo radiotherapy~mycophenolate mofetil: Given IV or PO~tacrolimus: Given IV or PO~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~laboratory biomarker analysis: Correlative studies"
1251879|NCT00089011|P1|Participant Flow|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~fludarabine phosphate: Given IV~total-body irradiation: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies"
1251880|NCT00089011|O2|Outcome|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.~total-body irradiation: Undergo radiotherapy~mycophenolate mofetil: Given IV or PO~tacrolimus: Given IV or PO~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~laboratory biomarker analysis: Correlative studies"
1251881|NCT00089011|O1|Outcome|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~fludarabine phosphate: Given IV~total-body irradiation: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies"
1251882|NCT00089011|O2|Outcome|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.~total-body irradiation: Undergo radiotherapy~mycophenolate mofetil: Given IV or PO~tacrolimus: Given IV or PO~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~laboratory biomarker analysis: Correlative studies"
1251883|NCT00089011|O1|Outcome|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~fludarabine phosphate: Given IV~total-body irradiation: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies"
1251970|NCT00088530|B2|Baseline|Comparator Group|Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
1251971|NCT00088530|B1|Baseline|Experimental Group|Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle
1251884|NCT00089011|O2|Outcome|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.~total-body irradiation: Undergo radiotherapy~mycophenolate mofetil: Given IV or PO~tacrolimus: Given IV or PO~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~laboratory biomarker analysis: Correlative studies"
1251885|NCT00089011|O1|Outcome|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~fludarabine phosphate: Given IV~total-body irradiation: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies"
1251886|NCT00089011|O2|Outcome|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.~total-body irradiation: Undergo radiotherapy~mycophenolate mofetil: Given IV or PO~tacrolimus: Given IV or PO~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~laboratory biomarker analysis: Correlative studies"
1251887|NCT00089011|O1|Outcome|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~fludarabine phosphate: Given IV~total-body irradiation: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies"
1251888|NCT00089011|O2|Outcome|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.~total-body irradiation: Undergo radiotherapy~mycophenolate mofetil: Given IV or PO~tacrolimus: Given IV or PO~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~laboratory biomarker analysis: Correlative studies"
1252078|NCT00087672|P1|Participant Flow|CC-5013|10 mg orally daily
1251890|NCT00089011|O2|Outcome|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.~total-body irradiation: Undergo radiotherapy~mycophenolate mofetil: Given IV or PO~tacrolimus: Given IV or PO~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~laboratory biomarker analysis: Correlative studies"
1251891|NCT00089011|O1|Outcome|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~fludarabine phosphate: Given IV~total-body irradiation: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies"
1251892|NCT00089011|O2|Outcome|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.~total-body irradiation: Undergo radiotherapy~mycophenolate mofetil: Given IV or PO~tacrolimus: Given IV or PO~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~laboratory biomarker analysis: Correlative studies"
1251893|NCT00089011|O1|Outcome|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~fludarabine phosphate: Given IV~total-body irradiation: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies"
1251894|NCT00089011|O2|Outcome|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.~total-body irradiation: Undergo radiotherapy~mycophenolate mofetil: Given IV or PO~tacrolimus: Given IV or PO~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~laboratory biomarker analysis: Correlative studies"
1251895|NCT00089011|O1|Outcome|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~fludarabine phosphate: Given IV~total-body irradiation: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies"
1251896|NCT00089011|E2|Reported Event|Arm II (Nonmyeloablative Conditioning With TBI)|"Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.~total-body irradiation: Undergo radiotherapy~mycophenolate mofetil: Given IV or PO~tacrolimus: Given IV or PO~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant~laboratory biomarker analysis: Correlative studies"
1251897|NCT00089011|E1|Reported Event|Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.~fludarabine phosphate: Given IV~total-body irradiation: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies"
1251898|NCT00088985|B1|Baseline|Dendritic Cell Vaccine|"Dendritic Cells: Dosage: 20 x 106 DCs given per treatment Vinorelbine:25 mg/m2 will be administered i.v biweekly Trastuzumab: 6mg/Kg administered by i.v. biweekly~therapeutic autologous dendritic cells: 10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with GM-CSF 250 μg/m2 sc each day for four days. G-CSF and/or GM- CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection~trastuzumab: 4 mg/kg intravenously, every 14 days~vinorelbine ditartrate: Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days"
1251899|NCT00088985|P1|Participant Flow|Dendritic Cell Vaccine|"Dendritic Cells (DCs): Dosage: 20 x 106 DCs given per treatment Vinorelbine:25 mg/m2 will be administered i.v biweekly Trastuzumab: 6mg/Kg administered by i.v. biweekly~therapeutic autologous dendritic cells: 10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with Granulocyte-macrophage colony-stimulating factor (GM-CSF) 250 μg/m2 sc each day for four days. G-CSF and/or GM-CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection~trastuzumab: 4 mg/kg intravenously, every 14 days~vinorelbine ditartrate: Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days"
1251900|NCT00088985|O1|Outcome|Dendritic Cell Vaccine|"Dendritic Cells: Dosage: 20 x 106 DCs given per treatment Vinorelbine:25 mg/m2 will be administered i.v biweekly Trastuzumab: 6mg/Kg administered by i.v. biweekly~therapeutic autologous dendritic cells: 10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with GM-CSF 250 μg/m2 sc each day for four days. G-CSF and/or GM- CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection~trastuzumab: 4 mg/kg intravenously, every 14 days~vinorelbine ditartrate: Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days"
1251901|NCT00088985|E1|Reported Event|Dendritic Cell Vaccine|"Dendritic Cells: Dosage: 20 x 106 DCs given per treatment Vinorelbine:25 mg/m2 will be administered i.v biweekly Trastuzumab: 6mg/Kg administered by i.v. biweekly~therapeutic autologous dendritic cells: 10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with GM-CSF 250 μg/m2 sc each day for four days. G-CSF and/or GM- CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection~trastuzumab: 4 mg/kg intravenously, every 14 days~vinorelbine ditartrate: Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days"
1251902|NCT00088972|B3|Baseline|Total|Total of all reporting groups
1251909|NCT00088972|E2|Reported Event|Arm II|Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
1251910|NCT00088972|E1|Reported Event|Arm I|Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
1251911|NCT00088907|B3|Baseline|Total|Total of all reporting groups
1251912|NCT00088907|B2|Baseline|Arm II (Docetaxel and Gefitinib)|"Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~gefitinib: Given at a dose of 250 mg (one tablet) orally each day starting on day 1 and continuing for days 1 to 28 of each cycle until progression."
1251913|NCT00088907|B1|Baseline|Arm I (Docetaxel and Placebo)|"Patients receive docetaxel intravenously (IV) over 30-60 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~placebo: Given orally"
1251914|NCT00088907|P2|Participant Flow|Arm II (Docetaxel and Gefitinib)|"Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~gefitinib: Given at a dose of 250 mg (one tablet) orally each day starting on day 1 and continuing for days 1 to 28 of each cycle until progression."
1251915|NCT00088907|P1|Participant Flow|Arm I (Docetaxel and Placebo)|"Patients receive docetaxel intravenously (IV) over 30-60 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~placebo: Given orally"
1251916|NCT00088907|O2|Outcome|Arm II (Docetaxel and Gefitinib)|"Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~gefitinib: Given at a dose of 250 mg (one tablet) orally each day starting on day 1 and continuing for days 1 to 28 of each cycle until progression."
1251917|NCT00088907|O1|Outcome|Arm I (Docetaxel and Placebo)|"Patients receive docetaxel intravenously (IV) over 30-60 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~placebo: Given orally"
1251918|NCT00088907|O2|Outcome|Arm II (Docetaxel and Gefitinib)|"Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~gefitinib: Given at a dose of 250 mg (one tablet) orally each day starting on day 1 and continuing for days 1 to 28 of each cycle until progression."
1251972|NCT00088530|P2|Participant Flow|Comparator Group|Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
1251973|NCT00088530|P1|Participant Flow|Experimental Group|Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle)
1254345|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
1251919|NCT00088907|O1|Outcome|Arm I (Docetaxel and Placebo)|"Patients receive docetaxel intravenously (IV) over 30-60 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~placebo: Given orally"
1251920|NCT00088907|O2|Outcome|Arm II (Docetaxel and Gefitinib)|"Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~gefitinib: Given at a dose of 250 mg (one tablet) orally each day starting on day 1 and continuing for days 1 to 28 of each cycle until progression."
1251921|NCT00088907|O1|Outcome|Arm I (Docetaxel and Placebo)|"Patients receive docetaxel intravenously (IV) over 30-60 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~placebo: Given orally"
1251922|NCT00088907|E3|Reported Event|Step 2: ZD1839|ZD1839 (Iressa, gefitinib) 250 mg/daily orally starting on day 1. Treatment to continue from days 1-28 of each cycle.
1251923|NCT00088907|E2|Reported Event|Step 1: Docetaxel+ZD1839|"Premedication: Dexamethasone~Docetaxel as a 60 m inute infusion 35mg/m2 to be given on days 1,8, and 15 of a 28-day schedule.~ZD1839 (Iressa, gefitinib) 250 mg/daily orally starting on day 1. Treatment to continue from days 1-28 of each cycle."
1251924|NCT00088907|E1|Reported Event|Step 1: Docetaxel+Placebo|"Premedication: Dexamethasone~Docetaxel as a 60 m inute infusion 35mg/m2 to be given on days 1,8,and 15 of a 28-day schedule~Placebo one tablet daily orally starting on day 1. Treatment to continue from days 1-28 of each cycle."
1251925|NCT00088881|B1|Baseline|Treatment|"R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.~Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.~Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy."
1251996|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
1252079|NCT00087672|O1|Outcome|CC-5013|10 mg orally daily
1251926|NCT00088881|P1|Participant Flow|Treatment|"R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.~Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.~Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy."
1251927|NCT00088881|O1|Outcome|Treatment|"R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.~Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.~Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy."
1251928|NCT00088881|O1|Outcome|Treatment|"R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.~Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.~Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy."
1251929|NCT00088881|O1|Outcome|Treatment|"R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.~Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.~Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy."
1251974|NCT00088530|O2|Outcome|Comparator Group|Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
1251975|NCT00088530|O1|Outcome|Experimental Group|Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle
1251930|NCT00088881|O1|Outcome|Treatment|"R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.~Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.~Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy."
1251931|NCT00088881|E3|Reported Event|Step 3 - Radiation Therapy|Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy.
1251932|NCT00088881|E2|Reported Event|Step 2 - Zevalin™ Radioimmunotherapy|Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.
1251933|NCT00088881|E1|Reported Event|Step 1 - R-CHOP|Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.
1251934|NCT00088634|B3|Baseline|Total|Total of all reporting groups
1251935|NCT00088634|B2|Baseline|Placebo|Matching placebo to lurasidone 40 mg tablets taken once/day
1251936|NCT00088634|B1|Baseline|Lurasidone 80 mg|2 40 mg lurasidone tablets taken once/day
1251937|NCT00088634|P2|Participant Flow|Placebo|Matching placebo to lurasidone 40 mg tablets taken once/day
1251938|NCT00088634|P1|Participant Flow|Lurasidone 80 mg|2 40 mg lurasidone tablets taken once/day
1251939|NCT00088634|O2|Outcome|Placebo|Matching placebo to lurasidone 40 mg tablets taken once/day
1251940|NCT00088634|O1|Outcome|Lurasidone 80 mg|2 40 mg lurasidone tablets taken once/day
1251941|NCT00088634|O2|Outcome|Placebo|Matching placebo to lurasidone 40 mg tablets taken once/day
1251942|NCT00088634|O1|Outcome|Lurasidone 80 mg|2 40 mg lurasidone tablets taken once/day
1251943|NCT00088634|O2|Outcome|Placebo|Matching placebo to lurasidone 40 mg tablets taken once/day
1251944|NCT00088634|O1|Outcome|Lurasidone 80 mg|2 40 mg lurasidone tablets taken once/day
1251945|NCT00088634|O2|Outcome|Placebo|Matching placebo to lurasidone 40 mg tablets taken once/day
1251946|NCT00088634|O1|Outcome|Lurasidone 80 mg|2 40 mg lurasidone tablets taken once/day
1251947|NCT00088634|E2|Reported Event|Placebo|Matching placebo to lurasidone 40 mg tablets taken once/day
1251948|NCT00088634|E1|Reported Event|Lurasidone 80 mg|2 40 mg lurasidone tablets taken once/day
1251949|NCT00088621|B1|Baseline|Lurasidone 80 mg|Lurasidone 80mg oral tablet. The number of subjects that represent the baseline must have taken 1 dose of study medication and had post-baseline assessment. 2 subjects were randomized and did not take study medication and thus 59 subjects is listed in the baseline group.
1251950|NCT00088621|P1|Participant Flow|Lurasidone 80 mg|Lurasidone 80mg oral tablet. The number of subjects that represent the participant flow is based on the number of subjects that entered the extension study which is 61 subjects.
1251951|NCT00088621|O1|Outcome|Lurasidone 80 mg|Lurasidone 80mg oral tablet. The number of subjects that represent the baseline must have taken 1 dose of study medication and had post-baseline assessment. 2 subjects were randomized and did not take study medication and thus 59 subjects is listed in the baseline group.
1251952|NCT00088621|E1|Reported Event|Lurasidone 80 mg|Lurasidone 80mg oral tablet. The number of subjects that represent the baseline must have taken 1 dose of study medication and had post-baseline assessment. 2 subjects were randomized and did not take study medication and thus 59 subjects is listed in the baseline group.
1251953|NCT00088595|B1|Baseline|Pasireotide (Any Dose)|SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
1251954|NCT00088595|P1|Participant Flow|Pasireotide (Any Dose)|SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
1251955|NCT00088595|O1|Outcome|Pasireotide (Any Dose)|SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
1251956|NCT00088595|O1|Outcome|Pasireotide (Any Dose)|SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
1251957|NCT00088595|O4|Outcome|Pasireotide Any Dose|SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
1251958|NCT00088595|O3|Outcome|Pasireotide >1500-≤2400 μg|SOM230 (Pasireotide), more than 750µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
1251959|NCT00088595|O2|Outcome|Pasireotide >900-≤1500 μg|SOM230 (Pasireotide), more than 450µg twice daily dose titration up to 750µg twice daily, subcutaneous injection.
1251960|NCT00088595|O1|Outcome|Pasireotide 300-≤900 μg|SOM230 (Pasireotide), 150µg twice daily dose titration up to 450µg twice daily, subcutaneous injection.
1251961|NCT00088595|O4|Outcome|Pasireotide Any Dose|SOM230 (Pasireotide), 300 ug - 2400 ug / day
1251962|NCT00088595|O3|Outcome|Pasireotide >1500 - ≤2400 μg|SOM230 (Pasireotide), >1500 - ≤2400 μg / day
1251963|NCT00088595|O2|Outcome|Pasireotide >900 - ≤1500 μg|SOM230 (Pasireotide), >900 - ≤1500 μg / day
1251964|NCT00088595|O1|Outcome|Pasireotide 300 - ≤900 μg|SOM230 (Pasireotide), 300 - ≤900 μg / day
1251965|NCT00088595|O1|Outcome|Pasireotide (Any Dose)|SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
1251966|NCT00088595|E3|Reported Event|Pasireotide > 1500 ≤ 2400 μg|Pasireotide > 1500 ≤ 2400 μg / day
1251967|NCT00088595|E2|Reported Event|Pasireotide > 900 ≤ 1500 μg|Pasireotide > 900 ≤ 1500 μg / day
1251968|NCT00088595|E1|Reported Event|Pasireotide 300 ≤ 900 μg|Pasireotide 300 ≤ 900 μg / day
1251969|NCT00088530|B3|Baseline|Total|Total of all reporting groups
1251980|NCT00088530|O2|Outcome|Comparator Group|Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
1251981|NCT00088530|O1|Outcome|Experimental Group|Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle
1251982|NCT00088530|E2|Reported Event|Comparator Group|Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
1251983|NCT00088530|E1|Reported Event|Experimental Group|Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle
1251984|NCT00088465|B1|Baseline|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
1251985|NCT00088465|P1|Participant Flow|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
1251986|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
1251987|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
1251988|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
1251989|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
1251990|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
1251991|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
1251992|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
1251993|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
1251994|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
1251998|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
1251999|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
1252000|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
1252001|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
1252002|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
1252003|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
1252004|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
1252005|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
1252006|NCT00088465|E1|Reported Event|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
1252007|NCT00088374|B1|Baseline|VHL Associated Renal Tumors|17-AAG intravenous infusions at a dose of 300 mg/m2 into a vein once a week for 3 weeks out of every 4, for 3 months; on days 1, 8, and 15 of 28 cycles. The infusions last up to 1 to 2 hours.
1252008|NCT00088374|P1|Participant Flow|VHL Associated Renal Tumors|17-AAG intravenous infusions at a dose of 300 mg/m2 into a vein once a week for 3 weeks out of every 4, for 3 months; on days 1, 8, and 15 of 28 cycles. The infusions last up to 1 to 2 hours.
1252009|NCT00088374|O1|Outcome|Participants With VHL Associated Renal Tumors|
1252010|NCT00088374|O1|Outcome|Participants With VHL Associated Renal Tumors|
1252011|NCT00088374|O1|Outcome|Participants With VHL Associated Renal Tumors|
1252012|NCT00088374|O1|Outcome|Participants With VHL Associated Renal Tumors|
1252013|NCT00088374|O1|Outcome|Participants With VHL Associated Renal Tumors|
1252014|NCT00088374|O1|Outcome|Participants With VHL Associated Renal Tumors|
1252015|NCT00088374|E1|Reported Event|Participants With VHL Associated Renal Tumors|
1252016|NCT00088218|B3|Baseline|Total|Total of all reporting groups
1252017|NCT00088218|B2|Baseline|Clofarabine Plus Ara-C|Clofarabine IV 30 mg/m^2 daily times 5 days + Ara-C 20 mg/m^2 subcutaneously daily times 14 days.
1252018|NCT00088218|B1|Baseline|Clofarabine|Clofarabine intravenous (IV) 30 mg/m^2 daily times 5 days
1252019|NCT00088218|P2|Participant Flow|Clofarabine Plus Ara-C|Clofarabine IV 30 mg/m^2 daily times 5 days + Ara-C 20 mg/m^2 subcutaneously daily times 14 days.
1252020|NCT00088218|P1|Participant Flow|Clofarabine|Clofarabine intravenous (IV) 30 mg/m^2 daily times 5 days
1252021|NCT00088218|O2|Outcome|Clofarabine Plus Ara-C|Clofarabine IV 30 mg/m^2 daily times 5 days + Ara-C 20 mg/m^2 subcutaneously daily times 14 days.
1252022|NCT00088218|O1|Outcome|Clofarabine|Clofarabine intravenous (IV) 30 mg/m^2 daily times 5 days
1252023|NCT00088218|E2|Reported Event|Clofarabine Plus Ara-C|Clofarabine IV 30 mg/m^2 daily times 5 days + Ara-C 20 mg/m^2 subcutaneously daily times 14 days.
1252024|NCT00088218|E1|Reported Event|Clofarabine|Clofarabine intravenous (IV) 30 mg/m^2 daily times 5 days
1252025|NCT00088166|B3|Baseline|Total|Total of all reporting groups
1252026|NCT00088166|B2|Baseline|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
1252027|NCT00088166|B1|Baseline|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
1252028|NCT00088166|P2|Participant Flow|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
1252029|NCT00088166|P1|Participant Flow|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
1252030|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
1252031|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
1252032|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
1252033|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
1252034|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
1252035|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
1252036|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
1252037|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
1252038|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
1252039|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
1252040|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
1252041|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
1252042|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
1252043|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
1252044|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
1252045|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
1252046|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
1252047|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
1252048|NCT00088166|E2|Reported Event|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
1252049|NCT00088166|E1|Reported Event|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
1252050|NCT00088153|B3|Baseline|Total|Total of all reporting groups
1252051|NCT00088153|B2|Baseline|Placebo|Mature girls with anorexia nervosa with a bone age of 15 years of greater: Placebo patches; Immature girls with anorexia nervosa with a bone age of less than 15 years: Placebo pills
1252052|NCT00088153|B1|Baseline|Physiologic Estrogen Replacement|"Mature girls with anorexia nervosa (bone age 15 or greater): Transdermal estradiol (100 mcg) with cyclic progesterone (days 1-10 of each month).~Immature girls with anorexia nervosa (bone age less than 15 years): Ethinyl estradiol (3.75 mcg daily for the first 6 months, 7.5 mcg daily for the next 6 months, and 11.25 mcg daily for the final 6 months of the study"
1252053|NCT00088153|P2|Participant Flow|Placebo|Mature girls with anorexia nervosa with a bone age of 15 years of greater: Placebo patches; Immature girls with anorexia nervosa with a bone age of less than 15 years: Placebo pills
1252054|NCT00088153|P1|Participant Flow|Physiologic Estrogen Replacement|"Mature girls with anorexia nervosa (bone age 15 or greater): Transdermal estradiol (100 mcg) with cyclic progesterone (days 1-10 of each month).~Immature girls with anorexia nervosa (bone age less than 15 years): Ethinyl estradiol (3.75 mcg daily for the first 6 months, 7.5 mcg daily for the next 6 months, and 11.25 mcg daily for the final 6 months of the study"
1252055|NCT00088153|O2|Outcome|Placebo|"Mature girls with anorexia nervosa (AN) randomized to this arm received placebo patches and cyclic placebo pills.~Immature girls with AN randomized to this arm received placebo pills. All subjects received supplemental calcium (1200 mg) and vitamin D (400 IU) daily"
1252056|NCT00088153|O1|Outcome|Physiologic Estrogen Replacement|Mature girls with anorexia nervosa (AN) (bone age ≥15 years) randomized this arm received transdermal 17-β estradiol (100 mcg patch applied twice weekly) continuously over the study duration. Girls randomized to the active estradiol patch also received medroxyprogesterone 2.5 mg daily for 10 days each month. Immature girls with AN (bone age<15 years, N=14) randomized to this arm received escalating doses of oral ethinyl estradiol (3.75 mcg daily for the first 6 months, 7.5 mcg daily for the second 6 months, and 11.25 mcg daily for the last 6 months). All subjects were given 1200 mg calcium carbonate and 400 IU vitamin D daily.
1252057|NCT00088153|O2|Outcome|Placebo|"Mature girls with anorexia nervosa (AN) randomized to this arm received placebo patches and cyclic placebo pills.~Immature girls with AN randomized to this arm received placebo pills. All subjects received supplemental calcium (1200 mg) and vitamin D (400 IU) daily"
1252058|NCT00088153|O1|Outcome|Physiologic Estrogen Replacement|Mature girls with anorexia nervosa (AN) (bone age ≥15 years) randomized this arm received transdermal 17-β estradiol (100 mcg patch applied twice weekly) continuously over the study duration. Girls randomized to the active estradiol patch also received medroxyprogesterone 2.5 mg daily for 10 days each month. Immature girls with AN (bone age<15 years, N=14) randomized to this arm received escalating doses of oral ethinyl estradiol (3.75 mcg daily for the first 6 months, 7.5 mcg daily for the second 6 months, and 11.25 mcg daily for the last 6 months). All subjects were given 1200 mg calcium carbonate and 400 IU vitamin D daily.
1252059|NCT00088153|O2|Outcome|Placebo|"Mature girls with anorexia nervosa (AN) randomized to this arm received placebo patches and cyclic placebo pills.~Immature girls with AN randomized to this arm received placebo pills. All subjects received supplemental calcium (1200 mg) and vitamin D (400 IU) daily"
1252060|NCT00088153|O1|Outcome|Physiologic Estrogen Replacement|Mature girls with anorexia nervosa (AN) (bone age ≥15 years) randomized this arm received transdermal 17-β estradiol (100 mcg patch applied twice weekly) continuously over the study duration. Girls randomized to the active estradiol patch also received medroxyprogesterone 2.5 mg daily for 10 days each month. Immature girls with AN (bone age<15 years, N=14) randomized to this arm received escalating doses of oral ethinyl estradiol (3.75 mcg daily for the first 6 months, 7.5 mcg daily for the second 6 months, and 11.25 mcg daily for the last 6 months). All subjects were given 1200 mg calcium carbonate and 400 IU vitamin D daily.
1252061|NCT00088153|E2|Reported Event|Placebo|Mature girls with anorexia nervosa with a bone age of 15 years of greater: Placebo patches; Immature girls with anorexia nervosa with a bone age of less than 15 years: Placebo pills
1252062|NCT00088153|E1|Reported Event|Physiologic Estrogen Replacement|"Mature girls with anorexia nervosa (bone age 15 or greater): Transdermal estradiol (100 mcg) with cyclic progesterone (days 1-10 of each month).~Immature girls with anorexia nervosa (bone age less than 15 years): Ethinyl estradiol (3.75 mcg daily for the first 6 months, 7.5 mcg daily for the next 6 months, and 11.25 mcg daily for the final 6 months of the study"
1252063|NCT00087698|B1|Baseline|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
1252064|NCT00087698|P1|Participant Flow|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
1252065|NCT00087698|O1|Outcome|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
1252066|NCT00087698|O1|Outcome|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
1252067|NCT00087698|O1|Outcome|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
1252068|NCT00087698|O1|Outcome|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
1252069|NCT00087698|O1|Outcome|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
1252070|NCT00087698|O1|Outcome|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
1252071|NCT00087698|E1|Reported Event|Pemetrexed|pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 Gy
1252072|NCT00087685|B1|Baseline|RAD001|10 mg orally daily/28-day cycles
1252073|NCT00087685|P1|Participant Flow|RAD001|10 mg orally daily/28-day cycles
1252082|NCT00087646|B4|Baseline|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
1252083|NCT00087646|B3|Baseline|Group C|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
1252084|NCT00087646|B2|Baseline|Group B|Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
1252085|NCT00087646|B1|Baseline|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
1252086|NCT00087646|P4|Participant Flow|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
1252087|NCT00087646|P3|Participant Flow|Group C|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
1252088|NCT00087646|P2|Participant Flow|Group B|Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
1252089|NCT00087646|P1|Participant Flow|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
1252090|NCT00087646|O4|Outcome|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
1252091|NCT00087646|O3|Outcome|Group C|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
1252092|NCT00087646|O2|Outcome|Group B|Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
1252093|NCT00087646|O1|Outcome|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
1252094|NCT00087646|O4|Outcome|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
1252095|NCT00087646|O3|Outcome|Group C|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
1252096|NCT00087646|O2|Outcome|Group B|Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
1252097|NCT00087646|O1|Outcome|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
1252098|NCT00087646|O2|Outcome|Group C + Group D|"Group C - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.~Group D - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks."
1252099|NCT00087646|O1|Outcome|Group A + Group B|"Group A - Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.~Group B - Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks."
1252100|NCT00087646|O2|Outcome|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
1252101|NCT00087646|O1|Outcome|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
1252102|NCT00087646|O2|Outcome|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
1252590|NCT00086190|B3|Baseline|Placebo|Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
1252103|NCT00087646|O1|Outcome|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
1252104|NCT00087646|O2|Outcome|Group B + Group D|"Group B - Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.~Group D - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks."
1252105|NCT00087646|O1|Outcome|Group A + Group C|"Group A - Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.~Group C - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks."
1252106|NCT00087646|O2|Outcome|Group C + Group D|"Group C - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.~Group D - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks."
1252107|NCT00087646|O1|Outcome|Group A + Group B|"Group A - Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.~Group B - Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks."
1252108|NCT00087646|O2|Outcome|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
1252109|NCT00087646|O1|Outcome|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
1252110|NCT00087646|E4|Reported Event|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
1252111|NCT00087646|E3|Reported Event|Group C|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
1252112|NCT00087646|E2|Reported Event|Group B|Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
1252113|NCT00087646|E1|Reported Event|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
1252114|NCT00087633|B3|Baseline|Total|Total of all reporting groups
1252115|NCT00087633|B2|Baseline|Observation Arm|No antiviral therapy for HCV unless recurrence of HCV was histologically demonstrated. Once histological recurrence was demonstrated, patients received the same antiviral regimen as patients in the prophylaxis arm (ie, 48 weeks of combined PEG-IFN alfa-2a and ribavirin)
1252116|NCT00087633|B1|Baseline|Prophylaxis Arm|Pegylated interferon alfa-2a subcutaneously (SC) 135 μg/week for 4 weeks, then increased to 180 μg/week for the next 44 weeks, plus Ribavirin orally 400 mg/day (initial) to 1000 mg/day for patients <75 kg or 1200 mg/day for patients ≥75 kg PO (escalated) (maximum) administered orally
1252117|NCT00087633|P2|Participant Flow|Observation Arm|No antiviral therapy for HCV unless recurrence of HCV was histologically demonstrated. Once histological recurrence was demonstrated, patients received the same antiviral regimen as patients in the prophylaxis arm (ie, 48 weeks of combined PEG-IFN alfa-2a and ribavirin)
1252118|NCT00087633|P1|Participant Flow|Prophylaxis Arm|Pegylated interferon alfa-2a subcutaneously (SC) 135 μg/week for 4 weeks, then increased to 180 μg/week for the next 44 weeks, plus Ribavirin orally 400 mg/day (initial) to 1000 mg/day for patients <75 kg or 1200 mg/day for patients ≥75 kg PO (escalated) (maximum) administered orally
1252119|NCT00087633|O2|Outcome|Observation Arm|No antiviral therapy for HCV unless recurrence of HCV was histologically demonstrated. Once histological recurrence was demonstrated, patients received the same antiviral regimen as patients in the prophylaxis arm (ie, 48 weeks of combined PEG-IFN alfa-2a and ribavirin)
1252120|NCT00087633|O1|Outcome|Prophylaxis Arm|Pegylated interferon alfa-2a subcutaneously (SC) 135 μg/week for 4 weeks, then increased to 180 μg/week for the next 44 weeks, plus Ribavirin orally 400 mg/day (initial) to 1000 mg/day for patients <75 kg or 1200 mg/day for patients ≥75 kg PO (escalated) (maximum) administered orally
1252121|NCT00087633|O2|Outcome|Observation Arm|No antiviral therapy for HCV unless recurrence of HCV was histologically demonstrated. Once histological recurrence was demonstrated, patients received the same antiviral regimen as patients in the prophylaxis arm (ie, 48 weeks of combined PEG-IFN alfa-2a and ribavirin)
1252122|NCT00087633|O1|Outcome|Prophylaxis Arm|Pegylated interferon alfa-2a subcutaneously (SC) 135 μg/week for 4 weeks, then increased to 180 μg/week for the next 44 weeks, plus Ribavirin orally 400 mg/day (initial) to 1000 mg/day for patients <75 kg or 1200 mg/day for patients ≥75 kg PO (escalated) (maximum) administered orally
1252123|NCT00087633|E2|Reported Event|Observation Arm|No antiviral therapy for HCV unless recurrence of HCV was histologically demonstrated. Once histological recurrence was demonstrated, patients received the same antiviral regimen as patients in the prophylaxis arm (ie, 48 weeks of combined PEG-IFN alfa-2a and ribavirin)
1252124|NCT00087633|E1|Reported Event|Prophylaxis Arm|Pegylated interferon alfa-2a subcutaneously (SC) 135 μg/week for 4 weeks, then increased to 180 μg/week for the next 44 weeks, plus Ribavirin orally 400 mg/day (initial) to 1000 mg/day for patients <75 kg or 1200 mg/day for patients ≥75 kg PO (escalated) (maximum) administered orally
1252125|NCT00087607|B3|Baseline|Total|Total of all reporting groups
1252126|NCT00087607|B2|Baseline|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252127|NCT00087607|B1|Baseline|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252128|NCT00087607|P2|Participant Flow|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b (12 kD) [PEG-Intron] at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin [Rebetol] 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252129|NCT00087607|P1|Participant Flow|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a (40 kD) [Pegasys] at a dosage of 180 microgram (μg), subcutaneously (SC), once a week plus Ribavirin [Copegus] 1000 or 1200 milligram (mg)/day), orally, [according to body weight, lesser than or greater than/equal to (< or >/=) 75 kilogram (kg), respectively] twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252232|NCT00087555|P3|Participant Flow|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
1252130|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252131|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252132|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252133|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252134|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252135|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252136|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252173|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252137|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252138|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252139|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252140|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252141|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252142|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252143|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252144|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252145|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252146|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252147|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252148|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252149|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252150|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252151|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252152|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252153|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252154|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252155|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252156|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252157|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252158|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252159|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a180 μg SC once weekly plus Ribavirin1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252160|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252161|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252162|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252163|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252164|NCT00087607|E2|Reported Event|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252165|NCT00087607|E1|Reported Event|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
1252166|NCT00087594|B3|Baseline|Total|Total of all reporting groups
1252167|NCT00087594|B2|Baseline|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252168|NCT00087594|B1|Baseline|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 microgram (mcg) (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 milligram (mg)/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252169|NCT00087594|P2|Participant Flow|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252170|NCT00087594|P1|Participant Flow|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 microgram (mcg) (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 milligram (mg)/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252171|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252172|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252217|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
1252174|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252175|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252176|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252177|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252178|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252179|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252233|NCT00087555|P2|Participant Flow|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
1252234|NCT00087555|P1|Participant Flow|Placebo|Placebo taken as two equally divided nightly doses
1252180|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252181|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252182|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252183|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252184|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252185|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252186|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252187|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252188|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252189|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252190|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252191|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252218|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
1252192|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252193|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252194|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252195|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252196|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252197|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252198|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252235|NCT00087555|O3|Outcome|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
1252199|NCT00087594|E2|Reported Event|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252200|NCT00087594|E1|Reported Event|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
1252201|NCT00087568|B3|Baseline|Total|Total of all reporting groups
1252202|NCT00087568|B2|Baseline|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
1252203|NCT00087568|B1|Baseline|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
1252204|NCT00087568|P2|Participant Flow|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
1252205|NCT00087568|P1|Participant Flow|Non-Responders|Participants received Pegasys 180 micrograms (µg) subcutaneously (SC) once a week and ribavirin 1000 or 1200 milligrams per day [mg/day (< or >=75 kg body weight, respectively)], orally in divided doses for 60 weeks.
1252206|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
1252207|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
1252208|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
1252209|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
1252210|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
1252211|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
1252212|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
1252213|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
1252214|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
1252215|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
1252216|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
1252591|NCT00086190|B2|Baseline|Venlafaxine Extended Release|Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
1252219|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
1252220|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
1252221|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
1252222|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
1252223|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
1252224|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
1252225|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
1252226|NCT00087568|E2|Reported Event|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
1252227|NCT00087568|E1|Reported Event|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
1252228|NCT00087555|B4|Baseline|Total|Total of all reporting groups
1252229|NCT00087555|B3|Baseline|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
1252230|NCT00087555|B2|Baseline|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
1252236|NCT00087555|O2|Outcome|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
1252237|NCT00087555|O1|Outcome|Placebo|Placebo taken as two equally divided nightly doses
1252238|NCT00087555|E3|Reported Event|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
1252239|NCT00087555|E2|Reported Event|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
1252240|NCT00087555|E1|Reported Event|Placebo|Placebo taken as two equally divided nightly doses
1252241|NCT00087529|B3|Baseline|Total|Total of all reporting groups
1252242|NCT00087529|B2|Baseline|Rituximab|Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
1252243|NCT00087529|B1|Baseline|Placebo|Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
1252244|NCT00087529|P2|Participant Flow|Rituximab|Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
1252245|NCT00087529|P1|Participant Flow|Placebo|Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
1252246|NCT00087529|O2|Outcome|Rituximab|Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
1252247|NCT00087529|O1|Outcome|Placebo|Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
1252248|NCT00087529|O2|Outcome|Rituximab|Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
1252249|NCT00087529|O1|Outcome|Placebo|Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
1252250|NCT00087529|O2|Outcome|Rituximab|Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
1252251|NCT00087529|O1|Outcome|Placebo|Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
1252252|NCT00087529|O2|Outcome|Rituximab|Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
1252253|NCT00087529|O1|Outcome|Placebo|Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
1252254|NCT00087529|E2|Reported Event|Rituximab|Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
1252255|NCT00087529|E1|Reported Event|Placebo|Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
1252256|NCT00087516|B4|Baseline|Total|Total of all reporting groups
1252257|NCT00087516|B3|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 or 200 mg q.d. during the 80-week Phase B study period.
1252258|NCT00087516|B2|Baseline|Sitagliptin 200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
1252259|NCT00087516|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
1252260|NCT00087516|P4|Participant Flow|Placebo/Sitagliptin 200 mg|The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period.
1252261|NCT00087516|P3|Participant Flow|Placebo/Sitagliptin 100 mg|The Placebo/Sitagliptin 100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 mg q.d. during the 80-week Phase B study period.
1252390|NCT00086684|E1|Reported Event|PLACEBO|
1252262|NCT00087516|P2|Participant Flow|Sitagliptin 200 mg/200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
1252263|NCT00087516|P1|Participant Flow|Sitagliptin 100 mg/100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
1252264|NCT00087516|O4|Outcome|Placebo/Sitagliptin 200 mg|The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period.
1252265|NCT00087516|O3|Outcome|Placebo/Sitagliptin 100 mg|The Placebo/Sitagliptin 100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 mg q.d. during the 80-week Phase B study period.
1252266|NCT00087516|O2|Outcome|Sitagliptin 200 mg/200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
1252267|NCT00087516|O1|Outcome|Sitagliptin 100 mg/100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
1252268|NCT00087516|O4|Outcome|Placebo/Sitagliptin 200 mg|The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period.
1252269|NCT00087516|O3|Outcome|Placebo/Sitagliptin 100 mg|The Placebo/Sitagliptin 100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 mg q.d. during the 80-week Phase B study period.
1252270|NCT00087516|O2|Outcome|Sitagliptin 200 mg/200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
1252271|NCT00087516|O1|Outcome|Sitagliptin 100 mg/100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
1252272|NCT00087516|O4|Outcome|Placebo/Sitagliptin 200 mg|The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period.
1252273|NCT00087516|O3|Outcome|Placebo/ Sitagliptin 100 mg|The Placebo/Sitagliptin 100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 mg q.d. during the 80-week Phase B study period.
1252274|NCT00087516|O2|Outcome|Sitagliptin 200 mg/200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
1252275|NCT00087516|O1|Outcome|Sitagliptin 100 mg/100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
1252276|NCT00087516|O3|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 or 200 mg q.d. during the 80-week Phase B study period.
1252277|NCT00087516|O2|Outcome|Sitagliptin 200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
1252278|NCT00087516|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
1252279|NCT00087516|O3|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 or 200 mg q.d. during the 80-week Phase B study period.
1252280|NCT00087516|O2|Outcome|Sitagliptin 200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
1252281|NCT00087516|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
1252282|NCT00087516|O3|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 or 200 mg q.d. during the 80-week Phase B study period.
1252283|NCT00087516|O2|Outcome|Sitagliptin 200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
1252284|NCT00087516|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
1252391|NCT00086619|B3|Baseline|Total|Total of all reporting groups
1252285|NCT00087516|E4|Reported Event|Placebo/Sitagliptin 200 mg|The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period.
1252286|NCT00087516|E3|Reported Event|Placebo/Sitagliptin 100 mg|The Placebo/Sitagliptin 100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 mg q.d. during the 80-week Phase B study period.
1252287|NCT00087516|E2|Reported Event|Sitagliptin 200 mg/200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
1252288|NCT00087516|E1|Reported Event|Sitagliptin 100 mg/100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
1252289|NCT00087490|B3|Baseline|Total|Total of all reporting groups
1252290|NCT00087490|B2|Baseline|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252291|NCT00087490|B1|Baseline|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252292|NCT00087490|P2|Participant Flow|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg per kilogram per dose (15 mg/kg/dose) over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252293|NCT00087490|P1|Participant Flow|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 milligram (mg). Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented methicillin-resistant Staphylococcus aureus (MRSA) bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252294|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252295|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252296|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252297|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252298|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252320|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252299|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252300|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252301|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252302|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252303|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252304|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252305|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252306|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253210|NCT00083759|O2|Outcome|Placebo|Placebo IV infusions + methotrexate (MTX)
1252307|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252308|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252309|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252310|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252311|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252312|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252313|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252314|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252315|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252316|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252317|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252318|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252319|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252505|NCT00086385|B5|Baseline|Total|Total of all reporting groups
1252321|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252322|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252323|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252324|NCT00087490|E2|Reported Event|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252325|NCT00087490|E1|Reported Event|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1252326|NCT00087438|B1|Baseline|Stereotactic Body Radiation Therapy (SBRT)|"20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy~stereotactic body radiation therapy"
1252327|NCT00087438|P1|Participant Flow|Stereotactic Body Radiation Therapy (SBRT)|"20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy~stereotactic body radiation therapy"
1252328|NCT00087438|O1|Outcome|Stereotactic Body Radiation Therapy (SBRT)|"20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy~stereotactic body radiation therapy"
1252329|NCT00087438|E1|Reported Event|Stereotactic Body Radiation Therapy (SBRT)|"20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy~stereotactic body radiation therapy"
1252330|NCT00087152|B1|Baseline|Imatinib Mesylate & Capecitabine|Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle.
1252331|NCT00087152|P1|Participant Flow|Imatinib Mesylate & Capecitabine|Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle.
1252332|NCT00087152|O1|Outcome|Imatinib Mesylate and Capecitabine|Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle.
1252333|NCT00087152|O1|Outcome|Imatinib Mesylate & Capecitabine|Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle.
1252334|NCT00087152|O1|Outcome|Imatinib Mesylate & Capecitabine|Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle.
1252335|NCT00087152|E1|Reported Event|Imatinib Mesylate and Capecitabine|Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle.
1252336|NCT00087139|B4|Baseline|Total|Total of all reporting groups
1252337|NCT00087139|B3|Baseline|Ixabepilone - Two Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
1252338|NCT00087139|B2|Baseline|Ixabepilone - Prior Taxane|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
1252339|NCT00087139|B1|Baseline|Ixabepilone - no Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
1252340|NCT00087139|P3|Participant Flow|Ixabepilone - Two Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
1252341|NCT00087139|P2|Participant Flow|Ixabepilone - Prior Taxane|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
1252342|NCT00087139|P1|Participant Flow|Ixabepilone - no Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
1252343|NCT00087139|O3|Outcome|Ixabepilone - Two Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
1252344|NCT00087139|O2|Outcome|Ixabepilone - Prior Taxane|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
1252345|NCT00087139|O1|Outcome|Ixabepilone - no Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
1252346|NCT00087139|O3|Outcome|Ixabepilone - Two Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
1252347|NCT00087139|O2|Outcome|Ixabepilone - Prior Taxane|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
1252348|NCT00087139|O1|Outcome|Ixabepilone - no Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
1252349|NCT00087139|O3|Outcome|Ixabepilone - Two Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
1252350|NCT00087139|O2|Outcome|Ixabepilone - Prior Taxane|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
1252351|NCT00087139|O1|Outcome|Ixabepilone - no Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
1252352|NCT00087139|O3|Outcome|Ixabepilone - Two Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
1252353|NCT00087139|O2|Outcome|Ixabepilone - Prior Taxane|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
1252354|NCT00087139|O1|Outcome|Ixabepilone - no Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
1252355|NCT00087139|E1|Reported Event|Ixabepilone|All patients who received protocol therapy, regardless of eligibility, were evaluated for toxicities.
1252356|NCT00086996|B1|Baseline|Chemo Plus RT, Surgery, Chemo|Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
1252357|NCT00086996|P1|Participant Flow|Chemo Plus RT, Surgery, Chemo|"Neoadjuvant chemoradiotherapy: Patients receive oxaliplatin 85 mg/m^2 by 2-hour IV infusion days 1, 15, and 29 and fluorouracil (5-FU) 180 mg/m^2/day infusion continuously on days 8-43. Beginning on day 8, patients also undergo radiotherapy at 180 centigray (cGy)/day, 5 days a week, for 5 weeks to a total dose of 4,500 cGy.~Surgery: Patients with stable disease or better undergo surgical resection 4-10 weeks after completion of chemoradiotherapy. The surgical technique will depend upon the location and extent of tumor and individual surgeon preference.~Adjuvant chemotherapy: Beginning 4-10 weeks after surgery, patients receive chemotherapy comprising oxaliplatin 85 mg/m^2 by 2-hour IV infusion days 1, 15, and 29 and 5-FU 180 mg/m^2/day by 24-hour infusion continuously on days 1-36."
1252358|NCT00086996|O1|Outcome|Chemo Plus RT, Surgery, Chemo|Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
1252359|NCT00086996|O1|Outcome|Chemo Plus RT, Surgery, Chemo|Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
1252360|NCT00086996|O1|Outcome|Chemo Plus RT, Surgery, Chemo|Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
1252361|NCT00086996|O1|Outcome|Chemo Plus RT, Surgery, Chemo|Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
1252362|NCT00086996|E1|Reported Event|Chemo Plus RT, Surgery, Chemo|Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
1252363|NCT00086957|B1|Baseline|Dose Levels 1 & 2 - Docetaxel 60 & 75 mg/m^2|"trastuzumab: Cycle 1 loading dose of 8 mg/kg, followed by 6 mg/kg every 3 weeks for subsequent cycles.~docetaxel: 75 mg/m^2 every three weeks, or 60 mg/m^2 every three weeks depending on study findings~gefitinib: 250 mg daily or 250 mg daily on days 2 through 14 depending on study findings"
1252364|NCT00086957|P3|Participant Flow|Phase II - Docetaxel 60 mg/m^2|Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m^2 intravenously every 3 weeks.
1252365|NCT00086957|P2|Participant Flow|Phase I - Docetaxel 60 mg/m^2|Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m^2 intravenously every 3 weeks.
1252366|NCT00086957|P1|Participant Flow|Phase I - Docetaxel 75 mg/m^2|Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 75 mg/m^2 intravenously every 3 weeks.
1252367|NCT00086957|O1|Outcome|Dose Level 2 - Docetaxel 60 mg/m^2|Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m^2 intravenously every 3 weeks.
1252368|NCT00086957|O1|Outcome|Dose Level 2 - Docetaxel 60 mg/m^2|Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m^2 intravenously every 3 weeks.
1252369|NCT00086957|O1|Outcome|Dose Level 2 - Docetaxel 60 mg/m^2|Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m2 intravenously every 3 weeks.
1252370|NCT00086957|O1|Outcome|Phase I|All patients enrolled on the Phase I (dose-finding) portion of the study.
1252371|NCT00086957|O2|Outcome|Phase I: Dose Level 2 - Docetaxel 60 mg/m^2|Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m^2 intravenously every 3 weeks.
1252372|NCT00086957|O1|Outcome|Phase I: Dose Level 1 - Docetaxel 75 mg/m^2|Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 75 mg/m^2 intravenously every 3 weeks.
1252373|NCT00086957|E2|Reported Event|Dose Level 2 - Docetaxel 60 mg/m^2|Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m^2 intravenously every 3 weeks.
1252374|NCT00086957|E1|Reported Event|Dose Level 1 - Docetaxel 75 mg/m^2|Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 75 mg/m^2 intravenously every 3 weeks.
1252375|NCT00086684|B4|Baseline|Total|Total of all reporting groups
1252376|NCT00086684|B3|Baseline|Pentosan Polysulfate Sodium (ELMIRON) 100MG TID|One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
1252377|NCT00086684|B2|Baseline|Pentosan Polysulfate Sodium (ELMIRON) 100MG QD|One 100 mg pentosan polysulfate sodium capsule QD (once daily)
1252378|NCT00086684|B1|Baseline|PLACEBO|
1252379|NCT00086684|P3|Participant Flow|Pentosan Polysulfate Sodium (ELMIRON) 100MG TID|One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
1252380|NCT00086684|P2|Participant Flow|Pentosan Polysulfate Sodium (ELMIRON) 100MG QD|One 100 mg pentosan polysulfate sodium capsule QD (once daily)
1252381|NCT00086684|P1|Participant Flow|PLACEBO|
1252382|NCT00086684|O3|Outcome|Pentosan Polysulfate Sodium (ELMIRON) 100MG TID|One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
1252383|NCT00086684|O2|Outcome|Pentosan Polysulfate Sodium (ELMIRON) 100MG QD|One 100 mg pentosan polysulfate sodium capsule QD (once daily)
1252384|NCT00086684|O1|Outcome|PLACEBO|
1252385|NCT00086684|O3|Outcome|Pentosan Polysulfate Sodium (ELMIRON) 100MG TID|One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
1252386|NCT00086684|O2|Outcome|Pentosan Polysulfate Sodium (ELMIRON) 100MG QD|One 100 mg pentosan polysulfate sodium capsule QD (once daily)
1252387|NCT00086684|O1|Outcome|PLACEBO|
1252388|NCT00086684|E3|Reported Event|Pentosan Polysulfate Sodium (ELMIRON) 100MG TID|One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
1252389|NCT00086684|E2|Reported Event|Pentosan Polysulfate Sodium (ELMIRON) 100MG QD|One 100 mg pentosan polysulfate sodium capsule QD (once daily)
1252392|NCT00086619|B2|Baseline|Ascending Dose PTH|Participants received ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).
1252393|NCT00086619|B1|Baseline|Constant Dose PTH|Participants received constant dose synthetic hPTH 1-34 (30 mcg/day).
1252394|NCT00086619|P2|Participant Flow|Ascending Dose PTH|Participants received ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).
1252395|NCT00086619|P1|Participant Flow|Constant Dose PTH|Participants received constant dose synthetic hPTH 1-34 (30 mcg/day).
1252396|NCT00086619|O2|Outcome|Ascending Dose PTH|Participants received ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).
1252397|NCT00086619|O1|Outcome|Constant Dose PTH|Participants received constant dose synthetic hPTH 1-34 (30 mcg/day).
1252398|NCT00086619|O2|Outcome|Ascending Dose PTH|Participants received ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).
1252399|NCT00086619|O1|Outcome|Constant Dose PTH|Participants received constant dose synthetic hPTH 1-34 (30 mcg/day).
1252400|NCT00086619|E2|Reported Event|Ascending Dose PTH|Participants received ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).
1252401|NCT00086619|E1|Reported Event|Constant Dose PTH|Participants received constant dose synthetic hPTH 1-34 (30 mcg/day).
1252402|NCT00086580|B3|Baseline|Total|Total of all reporting groups
1252403|NCT00086580|B2|Baseline|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
1252404|NCT00086580|B1|Baseline|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
1252405|NCT00086580|P2|Participant Flow|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
1252406|NCT00086580|P1|Participant Flow|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
1252407|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
1252408|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
1252409|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
1252410|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
1252411|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
1252412|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
1252413|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
1252414|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
1252415|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
1252416|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
1252417|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
1252418|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
1252419|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
1252420|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
1252421|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
1252422|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
1252423|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
1252610|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
1253211|NCT00083759|O1|Outcome|Natalizumab|Natalizumab 300 mg as monthly IV infusions + methotrexate (MTX)
1252424|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
1252425|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
1252426|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
1252427|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
1252428|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
1252429|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
1252430|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
1252431|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
1252432|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
1252433|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
1252434|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
1252435|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
1252436|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
1252437|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
1252438|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
1252439|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
1252440|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
1252441|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
1252442|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
1252443|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
1252444|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
1252445|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
1252446|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
1252447|NCT00086580|E2|Reported Event|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
1252448|NCT00086580|E1|Reported Event|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
1252449|NCT00086515|B3|Baseline|Total|Total of all reporting groups
1252468|NCT00086502|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
1252450|NCT00086515|B2|Baseline|Placebo / Glipizide 5 mg|"The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral~tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase~B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with~oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,~in a blinded fashion, to a maximum dose of 15 mg/day."
1252451|NCT00086515|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.
1252452|NCT00086515|P2|Participant Flow|Placebo / Glipizide 5 mg|"The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral~tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase~B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with~oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,~in a blinded fashion, to a maximum dose of 15 mg/day."
1252453|NCT00086515|P1|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.
1252454|NCT00086515|O2|Outcome|Placebo / Glipizide 5 mg|"The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral~tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase~B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with~oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,~in a blinded fashion, to a maximum dose of 15 mg/day."
1252455|NCT00086515|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.
1252456|NCT00086515|O2|Outcome|Placebo / Glipizide 5 mg|"The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral~tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase~B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with~oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,~in a blinded fashion, to a maximum dose of 15 mg/day."
1252457|NCT00086515|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.
1252458|NCT00086515|O2|Outcome|Placebo / Glipizide 5 mg|"The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral~tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase~B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with~oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,~in a blinded fashion, to a maximum dose of 15 mg/day."
1252459|NCT00086515|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.
1252592|NCT00086190|B1|Baseline|Paroxetine|Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
1252460|NCT00086515|E2|Reported Event|Placebo / Glipizide 5 mg|"The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral~tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase~B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with~oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,~in a blinded fashion, to a maximum dose of 15 mg/day."
1252461|NCT00086515|E1|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.
1252462|NCT00086502|B3|Baseline|Total|Total of all reporting groups
1252463|NCT00086502|B2|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo matching sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
1252464|NCT00086502|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
1252465|NCT00086502|P2|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo matching sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
1252466|NCT00086502|P1|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
1252467|NCT00086502|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo matching sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
1252611|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
1252469|NCT00086502|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo matching sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
1252470|NCT00086502|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
1252471|NCT00086502|E2|Reported Event|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo matching sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
1252472|NCT00086502|E1|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
1252473|NCT00086450|B3|Baseline|Total|Total of all reporting groups
1252474|NCT00086450|B2|Baseline|Coronary Artery Bypass Graft|Coronary Artery Bypass Graft
1252475|NCT00086450|B1|Baseline|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
1252476|NCT00086450|P2|Participant Flow|Coronary Artery Bypass Graft|Coronary Artery Bypass Graft
1252477|NCT00086450|P1|Participant Flow|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
1252478|NCT00086450|O2|Outcome|Coronary Artery Bypass Graft|Coronary Artery Bypass Graft
1252479|NCT00086450|O1|Outcome|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
1252480|NCT00086450|O2|Outcome|Coronary Artery Bypass Graft|Coronary Artery Bypass Graft
1252481|NCT00086450|O1|Outcome|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
1252482|NCT00086450|O2|Outcome|Coronary Artery Bypass Graft|Coronary Artery Bypass Graft
1252483|NCT00086450|O1|Outcome|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
1252484|NCT00086450|O2|Outcome|Coronary Artery Bypass Graft|Coronary Artery Bypass Graft
1252485|NCT00086450|O1|Outcome|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
1252486|NCT00086450|E2|Reported Event|Coronary Artery Bypass Graft|Coronary Artery Bypass Graft
1252487|NCT00086450|E1|Reported Event|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
1252488|NCT00086411|B5|Baseline|Total|Total of all reporting groups
1252489|NCT00086411|B4|Baseline|4 Patch+Mayo|patch and Mayo counseling with placebo patch
1252490|NCT00086411|B3|Baseline|3 Patch+MM|patch and MM with placebo pills
1252491|NCT00086411|B2|Baseline|2 Bup+Mayo|bupropion and Mayo counseling with placebo patch.
1252492|NCT00086411|B1|Baseline|1: Bup+MM|bupropion and MM with placebo patch
1252493|NCT00086411|P4|Participant Flow|4 Patch+Mayo|patch and Mayo counseling with placebo patch
1252494|NCT00086411|P3|Participant Flow|3 Patch+MM|patch and MM with placebo pills
1252495|NCT00086411|P2|Participant Flow|2 Bup+Mayo|bupropion and Mayo counseling with placebo patch.
1252496|NCT00086411|P1|Participant Flow|1 Bup+MM|bupropion and MM with placebo patch
1252497|NCT00086411|O4|Outcome|4 Patch+Mayo|patch and Mayo counseling with placebo patch
1252498|NCT00086411|O3|Outcome|3 Patch+mm|patch and MM with placebo pills
1252499|NCT00086411|O2|Outcome|2 Bup+Mayo|bupropion and Mayo counseling with placebo patch.
1252500|NCT00086411|O1|Outcome|1: Bup+MM|bupropion and MM with placebo patch
1252501|NCT00086411|E4|Reported Event|4 Patch+Mayo|patch and Mayo counseling with placebo patch
1252502|NCT00086411|E3|Reported Event|3 Patch+mm|patch and MM with placebo pills
1252503|NCT00086411|E2|Reported Event|2 Bup+Mayo|bupropion and Mayo counseling with placebo patch.
1252504|NCT00086411|E1|Reported Event|1: Bup+MM|bupropion and MM with placebo patch
1252506|NCT00086385|B4|Baseline|Tailored/No Extended NRT|"This condition is identical to the Tailored/NRT condition except that no NRT is available after completion of the Brief Treatment.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
1252507|NCT00086385|B3|Baseline|Extended Tailored Counseling + NRT|"Tailored Counseling Treatment- The primary goal of the extended treatment is to prevent relapse. Secondary goal is to encourage initiation of abstinence for those who have no attained it by Week 12, and re-initiation of abstinence after slips. Subjects will participate in the Brief Treatment followed by individual sessions. The first extended treatment counseling session will occur at Week 10. Additional sessions will be held every two weeks then every four weeks, and finally at Weeks 44 and 52. Each session will be 20-30 minutes long. Between sessions subjects will be contacted by phone for brief check-ins (5-10 minutes).~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
1252508|NCT00086385|B2|Baseline|Extended NRT|"Pharmacological Treatment - Following completion of the Brief Treatment, subjects assigned to this condition will continue receiving NRT for up to 52 weeks. Subjects in this condition will be encouraged to continue NRT through Week 24. If a subject who terminates NRT and resumes smoking, before Week 50, will be instructed to set a quite date and resume NRT.~Counseling Treatment - This is identical to the Brief Counseling described above.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
1252509|NCT00086385|B1|Baseline|Brief Treatment|"Pharmacological Treatment - Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment~Brief Counseling - The counseling intervention consist of five 90-minute group meetings.~No further treatment during Weeks 12-52.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
1252510|NCT00086385|P4|Participant Flow|Tailored/No Extended NRT|"This condition is identical to the Tailored/NRT condition except that no NRT is available after completion of the Brief Treatment.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
1252554|NCT00086281|B12|Baseline|P Then X|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
1252511|NCT00086385|P3|Participant Flow|Extended Tailored Counseling + NRT|"Tailored Counseling Treatment- The primary goal of the extended treatment is to prevent relapse. Secondary goal is to encourage initiation of abstinence for those who have no attained it by Week 12, and re-initiation of abstinence after slips. Subjects will participate in the Brief Treatment followed by individual sessions. The first extended treatment counseling session will occur at Week 10. Additional sessions will be held every two weeks then every four weeks, and finally at Weeks 44 and 52. Each session will be 20-30 minutes long. Between sessions subjects will be contacted by phone for brief check-ins (5-10 minutes).~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
1252512|NCT00086385|P2|Participant Flow|Extended NRT|"Pharmacological Treatment - Following completion of the Brief Treatment, subjects assigned to this condition will continue receiving NRT for up to 52 weeks. Subjects in this condition will be encouraged to continue NRT through Week 24. If a subject who terminates NRT and resumes smoking, before Week 50, will be instructed to set a quite date and resume NRT.~Counseling Treatment - This is identical to the Brief Counseling described above.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
1252513|NCT00086385|P1|Participant Flow|Brief Treatment|"Pharmacological Treatment - Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment~Brief Counseling - The counseling intervention consist of five 90-minute group meetings.~No further treatment during Weeks 12-52.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
1252514|NCT00086385|O4|Outcome|Tailored/No Extended NRT|"This condition is identical to the Tailored/NRT condition except that no NRT is available after completion of the Brief Treatment.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
1252515|NCT00086385|O3|Outcome|Extended Tailored Counseling + NRT|"Tailored Counseling Treatment- The primary goal of the extended treatment is to prevent relapse. Secondary goal is to encourage initiation of abstinence for those who have no attained it by Week 12, and re-initiation of abstinence after slips. Subjects will participate in the Brief Treatment followed by individual sessions. The first extended treatment counseling session will occur at Week 10. Additional sessions will be held every two weeks then every four weeks, and finally at Weeks 44 and 52. Each session will be 20-30 minutes long. Between sessions subjects will be contacted by phone for brief check-ins (5-10 minutes).~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
1252516|NCT00086385|O2|Outcome|Extended NRT|"Pharmacological Treatment - Following completion of the Brief Treatment, subjects assigned to this condition will continue receiving NRT for up to 52 weeks. Subjects in this condition will be encouraged to continue NRT through Week 24. If a subject who terminates NRT and resumes smoking, before Week 50, will be instructed to set a quite date and resume NRT.~Counseling Treatment - This is identical to the Brief Counseling described above.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
1252517|NCT00086385|O1|Outcome|Brief Treatment|"Pharmacological Treatment - Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment~Brief Counseling - The counseling intervention consist of five 90-minute group meetings.~No further treatment during Weeks 12-52.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
1252518|NCT00086385|E4|Reported Event|Tailored/No Extended NRT|"This condition is identical to the Tailored/NRT condition except that no NRT is available after completion of the Brief Treatment.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
1252563|NCT00086281|B3|Baseline|X With M Then Z With P Then X Then P|Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later.
1252593|NCT00086190|P3|Participant Flow|Placebo|Placebo was made to match treatment options.
1252519|NCT00086385|E3|Reported Event|Extended Tailored Counseling + NRT|"Tailored Counseling Treatment- The primary goal of the extended treatment is to prevent relapse. Secondary goal is to encourage initiation of abstinence for those who have no attained it by Week 12, and re-initiation of abstinence after slips. Subjects will participate in the Brief Treatment followed by individual sessions. The first extended treatment counseling session will occur at Week 10. Additional sessions will be held every two weeks then every four weeks, and finally at Weeks 44 and 52. Each session will be 20-30 minutes long. Between sessions subjects will be contacted by phone for brief check-ins (5-10 minutes).~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
1252520|NCT00086385|E2|Reported Event|Extended NRT|"Pharmacological Treatment - Following completion of the Brief Treatment, subjects assigned to this condition will continue receiving NRT for up to 52 weeks. Subjects in this condition will be encouraged to continue NRT through Week 24. If a subject who terminates NRT and resumes smoking, before Week 50, will be instructed to set a quite date and resume NRT.~Counseling Treatment - This is identical to the Brief Counseling described above.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
1252521|NCT00086385|E1|Reported Event|Brief Treatment|"Pharmacological Treatment - Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment~Brief Counseling - The counseling intervention consist of five 90-minute group meetings.~No further treatment during Weeks 12-52.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
1252522|NCT00086346|B3|Baseline|Total|Total of all reporting groups
1252523|NCT00086346|B2|Baseline|Calcineurin Inhibitors (CNI) Continuation|Calcineurin Inhibitors administered per local practice to attain target trough levels of 3 to 10 ng/mL (tacrolimus) or 50 to 250 ng/mL (cyclosporin A), respectively.
1252524|NCT00086346|B1|Baseline|Sirolimus (SRL) Conversion|Sirolimus was administered once daily. A loading dose of sirolimus, 10 to 15 mg, was administered in divided doses on day 1: the first dose was given after collection of the sirolimus trough level and a minimum of 4 hours following the last dose of CNI, and the second dose approximately 12 hours after the first dose. On days 2 through 6, sirolimus was administered in a dose of 3 to 5 mg/day. For the remaining study period, day 7 through month 72, appropriate daily doses of sirolimus were administered to attain the recommended trough concentrations of 8 to 16 ng/mL (using a chromatographic method) or 10 to 20 ng/mL (using an immunoassay).
1252525|NCT00086346|P2|Participant Flow|Calcineurin Inhibitors (CNI) Continuation|Calcineurin Inhibitors administered per local practice to attain target trough levels of 3 to 10 ng/mL (tacrolimus) or 50 to 250 ng/mL (cyclosporin A), respectively.
1252608|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
1252526|NCT00086346|P1|Participant Flow|Sirolimus (SRL) Conversion|Sirolimus was administered once daily. A loading dose of sirolimus, 10 to 15 mg, was administered in divided doses on day 1: the first dose was given after collection of the sirolimus trough level and a minimum of 4 hours following the last dose of CNI, and the second dose approximately 12 hours after the first dose. On days 2 through 6, sirolimus was administered in a dose of 3 to 5 mg/day. For the remaining study period, day 7 through month 72, appropriate daily doses of sirolimus were administered to attain the recommended trough concentrations of 8 to 16 ng/mL (using a chromatographic method) or 10 to 20 ng/mL (using an immunoassay).
1252527|NCT00086346|O2|Outcome|Calcineurin Inhibitors (CNI) Continuation|Calcineurin Inhibitors administered per local practice to attain target trough levels of 3 to 10 ng/mL (tacrolimus) or 50 to 250 ng/mL (cyclosporin A), respectively.
1252528|NCT00086346|O1|Outcome|Sirolimus (SRL) Conversion|Sirolimus was administered once daily. A loading dose of sirolimus, 10 to 15 mg, was administered in divided doses on day 1: the first dose was given after collection of the sirolimus trough level and a minimum of 4 hours following the last dose of CNI, and the second dose approximately 12 hours after the first dose. On days 2 through 6, sirolimus was administered in a dose of 3 to 5 mg/day. For the remaining study period, day 7 through month 72, appropriate daily doses of sirolimus were administered to attain the recommended trough concentrations of 8 to 16 ng/mL (using a chromatographic method) or 10 to 20 ng/mL (using an immunoassay).
1252529|NCT00086346|O2|Outcome|Calcineurin Inhibitors (CNI) Continuation|Calcineurin Inhibitors administered per local practice to attain target trough levels of 3 to 10 ng/mL (tacrolimus) or 50 to 250 ng/mL (cyclosporin A), respectively.
1252530|NCT00086346|O1|Outcome|Sirolimus (SRL) Conversion|Sirolimus was administered once daily. A loading dose of sirolimus, 10 to 15 mg, was administered in divided doses on day 1: the first dose was given after collection of the sirolimus trough level and a minimum of 4 hours following the last dose of CNI, and the second dose approximately 12 hours after the first dose. On days 2 through 6, sirolimus was administered in a dose of 3 to 5 mg/day. For the remaining study period, day 7 through month 72, appropriate daily doses of sirolimus were administered to attain the recommended trough concentrations of 8 to 16 ng/mL (using a chromatographic method) or 10 to 20 ng/mL (using an immunoassay).
1252531|NCT00086346|O2|Outcome|Calcineurin Inhibitors (CNI) Continuation|Calcineurin Inhibitors administered per local practice to attain target trough levels of 3 to 10 ng/mL (tacrolimus) or 50 to 250 ng/mL (cyclosporin A), respectively.
1252532|NCT00086346|O1|Outcome|Sirolimus (SRL) Conversion|Sirolimus was administered once daily. A loading dose of sirolimus, 10 to 15 mg, was administered in divided doses on day 1: the first dose was given after collection of the sirolimus trough level and a minimum of 4 hours following the last dose of CNI, and the second dose approximately 12 hours after the first dose. On days 2 through 6, sirolimus was administered in a dose of 3 to 5 mg/day. For the remaining study period, day 7 through month 72, appropriate daily doses of sirolimus were administered to attain the recommended trough concentrations of 8 to 16 ng/mL (using a chromatographic method) or 10 to 20 ng/mL (using an immunoassay).
1252533|NCT00086346|O2|Outcome|Calcineurin Inhibitors (CNI) Continuation|Calcineurin Inhibitors administered per local practice to attain target trough levels of 3 to 10 ng/mL (tacrolimus) or 50 to 250 ng/mL (cyclosporin A), respectively.
1252564|NCT00086281|B2|Baseline|X Then X With M Then P Then Z With P|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
1252534|NCT00086346|O1|Outcome|Sirolimus (SRL) Conversion|Sirolimus was administered once daily. A loading dose of sirolimus, 10 to 15 mg, was administered in divided doses on day 1: the first dose was given after collection of the sirolimus trough level and a minimum of 4 hours following the last dose of CNI, and the second dose approximately 12 hours after the first dose. On days 2 through 6, sirolimus was administered in a dose of 3 to 5 mg/day. For the remaining study period, day 7 through month 72, appropriate daily doses of sirolimus were administered to attain the recommended trough concentrations of 8 to 16 ng/mL (using a chromatographic method) or 10 to 20 ng/mL (using an immunoassay).
1252535|NCT00086346|E2|Reported Event|Calcineurin Inhibitors (CNI) Continuation|Calcineurin Inhibitors administered per local practice to attain target trough levels of 3 to 10 ng/mL (tacrolimus) or 50 to 250 ng/mL (cyclosporin A), respectively.
1252536|NCT00086346|E1|Reported Event|Sirolimus (SRL) Conversion|Sirolimus was administered once daily. A loading dose of sirolimus, 10 to 15 mg, was administered in divided doses on day 1: the first dose was given after collection of the sirolimus trough level and a minimum of 4 hours following the last dose of CNI, and the second dose approximately 12 hours after the first dose. On days 2 through 6, sirolimus was administered in a dose of 3 to 5 mg/day. For the remaining study period, day 7 through month 72, appropriate daily doses of sirolimus were administered to attain the recommended trough concentrations of 8 to 16 ng/mL (using a chromatographic method) or 10 to 20 ng/mL (using an immunoassay).
1252537|NCT00086307|B4|Baseline|Total|Total of all reporting groups
1252538|NCT00086307|B3|Baseline|Escitalopram and Pramipexole|Patients receive escitalopram and pramipexole.
1252539|NCT00086307|B2|Baseline|Escitalopram|Patients receive escitalopram and placebo.
1252540|NCT00086307|B1|Baseline|Pramipexole|Patients receive pramipexole and placebo.
1252541|NCT00086307|P3|Participant Flow|Escitalopram and Pramipexole|Patients receive escitalopram and pramipexole.
1252542|NCT00086307|P2|Participant Flow|Escitalopram|Patients receive escitalopram and placebo.
1252543|NCT00086307|P1|Participant Flow|Pramipexole|Patients receive pramipexole and placebo.
1252544|NCT00086307|O3|Outcome|Escitalopram and Pramipexole|Patients receive escitalopram and pramipexole.
1252545|NCT00086307|O2|Outcome|Escitalopram|Patients receive escitalopram and placebo.
1252546|NCT00086307|O1|Outcome|Pramipexole|Patients receive pramipexole and placebo.
1252547|NCT00086307|E3|Reported Event|Escitalopram and Pramipexole|Patients receive escitalopram and pramipexole.
1252548|NCT00086307|E2|Reported Event|Escitalopram|Patients receive escitalopram and placebo.
1252549|NCT00086307|E1|Reported Event|Pramipexole|Patients receive pramipexole and placebo.
1252550|NCT00086281|B16|Baseline|Total|Total of all reporting groups
1252551|NCT00086281|B15|Baseline|X With M|Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
1252552|NCT00086281|B14|Baseline|Xyrem|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
1252553|NCT00086281|B13|Baseline|Placebo|Placebo was given at bedtime and again 2.5 to 4 hours later
1252555|NCT00086281|B11|Baseline|Z With P Then P Then X With M|Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
1252556|NCT00086281|B10|Baseline|P Then X Then Z With P|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
1252557|NCT00086281|B9|Baseline|X With M Then X Then P Then Z With P|Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
1252558|NCT00086281|B8|Baseline|X Then X Then P Then Z With P|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
1252559|NCT00086281|B7|Baseline|X Then Z With P Then P Then X With M|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
1252560|NCT00086281|B6|Baseline|X Then Z With P Then X With M Then P|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Placebo was given at bedtime and again 2.5 to 4 hours later.
1252561|NCT00086281|B5|Baseline|P Then X Then P Then X With M Then Z With P|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
1252562|NCT00086281|B4|Baseline|Z With P Then P Then X With M Then X|Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
1252589|NCT00086190|B4|Baseline|Total|Total of all reporting groups
1252565|NCT00086281|B1|Baseline|P Then X Then Z With P Then X With M|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
1252566|NCT00086281|P15|Participant Flow|X With M|Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
1252567|NCT00086281|P14|Participant Flow|Xyrem|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
1252568|NCT00086281|P13|Participant Flow|Placebo|Placebo was given at bedtime and again 2.5 to 4 hours later
1252569|NCT00086281|P12|Participant Flow|P Then X|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
1252570|NCT00086281|P11|Participant Flow|Z With P Then P Then X With M|Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
1252571|NCT00086281|P10|Participant Flow|P Then X Then Z With P|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
1252572|NCT00086281|P9|Participant Flow|X With M Then X Then P Then Z With P|Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
1252609|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
1252661|NCT00086047|B3|Baseline|Total|Total of all reporting groups
1252573|NCT00086281|P8|Participant Flow|X Then X Then P Then Z With P|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
1252574|NCT00086281|P7|Participant Flow|X Then Z With P Then P Then X With M|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
1252575|NCT00086281|P6|Participant Flow|X Then Z With P Then X With M Then P|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Placebo was given at bedtime and again 2.5 to 4 hours later.
1252576|NCT00086281|P5|Participant Flow|P Then X Then P Then X With M Then Z With P|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
1252577|NCT00086281|P4|Participant Flow|Z With P Then P Then X With M Then X|Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
1252578|NCT00086281|P3|Participant Flow|X With M Then Z With P Then X Then P|Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later.
1252579|NCT00086281|P2|Participant Flow|X Then X With M Then P Then Z With P|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
1252580|NCT00086281|P1|Participant Flow|P Then X Then Z With P Then X With M|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
1252581|NCT00086281|O4|Outcome|Zolpidem + Placebo|Zolpidem + Placebo
1252582|NCT00086281|O3|Outcome|Xyrem + Modafinil|Xyrem + Modafinil
1252583|NCT00086281|O2|Outcome|Xyrem|Xyrem
1252584|NCT00086281|O1|Outcome|Placebo|Placebo
1252585|NCT00086281|E4|Reported Event|Z + P|Zolpidem + Placebo
1252586|NCT00086281|E3|Reported Event|X + M|Xyrem + Modafinil
1252587|NCT00086281|E2|Reported Event|Xyrem|Xyrem
1252588|NCT00086281|E1|Reported Event|Placebo|Placebo
1252594|NCT00086190|P2|Participant Flow|Venlafaxine Extended Release|Optimal venlafaxine extended release dosage was determined on a per patient basis. The mean dosage at week 12 was 121 +/- 75 mg/day.
1252595|NCT00086190|P1|Participant Flow|Paroxetine|Optimal paroxetine dosage was determined on a per patient basis. The mean dosage at week 12 was 24 +/- 11 mg/day.
1252596|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
1252597|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
1252598|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
1252599|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
1252600|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
1252601|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
1252602|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
1252603|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
1252604|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
1252605|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
1252606|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
1252607|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
1252612|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
1252613|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
1252614|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
1252615|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
1252616|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
1252617|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
1252618|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
1252619|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
1252620|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
1252621|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
1252622|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
1252623|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
1252624|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
1252625|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
1252626|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
1252627|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
1252628|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
1252629|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
1252630|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
1252631|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
1252632|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
1252633|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
1252634|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
1252635|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
1252636|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
1252637|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
1252638|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
1252639|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
1252640|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
1252641|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
1252642|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
1252643|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
1252644|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
1252645|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
1252646|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
1252647|NCT00086190|E3|Reported Event|Placebo|Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
1252648|NCT00086190|E2|Reported Event|Venlafaxine Extended Release|Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
1252649|NCT00086190|E1|Reported Event|Paroxetine|Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
1252650|NCT00086138|B3|Baseline|Total|Total of all reporting groups
1252651|NCT00086138|B2|Baseline|Placebo|"Participants will receive placebo matched to sertraline~Placebo: Placebo designed to mimic sertraline taken daily for 24 weeks"
1252652|NCT00086138|B1|Baseline|Sertraline|"Participants will receive sertraline at a target dose of 100mg daily.~Sertraline (Zoloft): Sertraline: range of 25 to 125 mg per day for 24 weeks"
1252653|NCT00086138|P2|Participant Flow|Sertraline|"Participants will receive sertraline at a target dose of 100mg daily.~Sertraline (Zoloft): Sertraline: range of 25 to 125 mg per day for 24 weeks"
1252654|NCT00086138|P1|Participant Flow|Placebo|"Participants will receive placebo matched to sertraline~Placebo: Placebo designed to mimic sertraline taken daily for 24 weeks"
1252655|NCT00086138|O2|Outcome|Placebo|"Participants will receive placebo matched to sertraline~Placebo: Placebo designed to mimic sertraline taken daily for 24 weeks"
1252656|NCT00086138|O1|Outcome|Sertraline|"Participants will receive sertraline at a target dose of 100mg daily.~Sertraline (Zoloft): Sertraline: range of 25 to 125 mg per day for 24 weeks"
1252657|NCT00086138|O2|Outcome|Placebo|"Participants will receive placebo matched to sertraline~Placebo: Placebo designed to mimic sertraline taken daily for 24 weeks"
1252658|NCT00086138|O1|Outcome|Sertraline|"Participants will receive sertraline at a target dose of 100mg daily.~Sertraline (Zoloft): Sertraline: range of 25 to 125 mg per day for 24 weeks"
1252659|NCT00086138|E2|Reported Event|Placebo|"Participants will receive placebo matched to sertraline~Placebo: Placebo designed to mimic sertraline taken daily for 24 weeks"
1252660|NCT00086138|E1|Reported Event|Sertraline|"Participants will receive sertraline at a target dose of 100mg daily.~Sertraline (Zoloft): Sertraline: range of 25 to 125 mg per day for 24 weeks"
1252662|NCT00086047|B2|Baseline|Education|Patient will receive 8 weekly sessions of education about fibromyalgia syndrome.
1252663|NCT00086047|B1|Baseline|Coping Skills|Patients will receive 8 weeks of behavioral training in pain coping strategies
1252664|NCT00086047|P2|Participant Flow|Education|Patient will receive 8 weekly sessions of education about fibromyalgia syndrome.
1252665|NCT00086047|P1|Participant Flow|Coping Skills|Patients will receive 8 weeks of behavioral training in pain coping strategies
1252666|NCT00086047|O2|Outcome|Fibromyalgia Education|Consists of education about fibromyalgia and its management
1252667|NCT00086047|O1|Outcome|Coping Skills Training|Consists of training in pain management skills using cognitive-behavioral therapy techniques
1252668|NCT00086047|E2|Reported Event|Education|Patient will receive 8 weekly sessions of education about fibromyalgia syndrome.
1252669|NCT00086047|E1|Reported Event|Coping Skills|Patients will receive 8 weeks of behavioral training in pain coping strategies
1252670|NCT00085917|B3|Baseline|Total|Total of all reporting groups
1252671|NCT00085917|B2|Baseline|Pegasys Double Dose|"pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks~- Total Treatment for 48 weeks"
1252672|NCT00085917|B1|Baseline|Pegasys Single Dose|"pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)~- Treatment for 48 weeks"
1252673|NCT00085917|P2|Participant Flow|Pegasys Double Dose|"pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks~- Total Treatment for 48 weeks"
1252674|NCT00085917|P1|Participant Flow|Pegasys Single Dose|"pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)~- Treatment for 48 weeks"
1252675|NCT00085917|O2|Outcome|Pegasys Double Dose|"pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks~- Total Treatment for 48 weeks"
1252676|NCT00085917|O1|Outcome|Pegasys Single Dose|"pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)~- Treatment for 48 weeks"
1252677|NCT00085917|O2|Outcome|Pegasys Double Dose|"pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks~- Total Treatment for 48 weeks"
1252678|NCT00085917|O1|Outcome|Pegasys Single Dose|"pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)~- Treatment for 48 weeks"
1252679|NCT00085917|O2|Outcome|Pegasys Double Dose|"pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks~- Total Treatment for 48 weeks"
1252680|NCT00085917|O1|Outcome|Pegasys Single Dose|"pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)~- Treatment for 48 weeks"
1252681|NCT00085917|E2|Reported Event|Pegasys Double Dose|"pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks~- Total Treatment for 48 weeks"
1252682|NCT00085917|E1|Reported Event|Pegasys Single Dose|"pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)~- Treatment for 48 weeks"
1252683|NCT00085839|B3|Baseline|Total|Total of all reporting groups
1252684|NCT00085839|B2|Baseline|Standard Chemotherapy|Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 – 30 minutes, both given on Day 1 every 21 days for 4 cycles
1252685|NCT00085839|B1|Baseline|Erlotinib|Erlotinib 150 mg/day continuous therapy
1252753|NCT00085644|P3|Participant Flow|Any Adalimumab|40 mg every other week (eow), subcutaneous (SC)
1252686|NCT00085839|P2|Participant Flow|Standard Chemotherapy|Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 – 30 minutes, both given on Day 1 every 21 days for 4 cycles
1252687|NCT00085839|P1|Participant Flow|Erlotinib|Erlotinib 150 mg/day continuous therapy
1252688|NCT00085839|O2|Outcome|Standard Chemotherapy|Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 – 30 minutes, both given on Day 1 every 21 days for 4 cycles
1252689|NCT00085839|O1|Outcome|Erlotinib|Erlotinib 150 mg/day continuous therapy
1252690|NCT00085839|O2|Outcome|Standard Chemotherapy|Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 – 30 minutes, both given on Day 1 every 21 days for 4 cycles
1252691|NCT00085839|O1|Outcome|Erlotinib|Erlotinib 150 mg/day continuous therapy
1252692|NCT00085839|O2|Outcome|Standard Chemotherapy|Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 – 30 minutes, both given on Day 1 every 21 days for 4 cycles
1252693|NCT00085839|O1|Outcome|Erlotinib|Erlotinib 150 mg/day continuous therapy
1252694|NCT00085839|E2|Reported Event|Standard Chemotherapy|Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 – 30 minutes, both given on Day 1 every 21 days for 4 cycles
1252695|NCT00085839|E1|Reported Event|Erlotinib|Erlotinib 150 mg/day continuous therapy
1252696|NCT00085735|B7|Baseline|Total|Total of all reporting groups
1252697|NCT00085735|B6|Baseline|Arm VI (8-21 Years of Age, SDCSI, PFRT)|Eligible patients 8-21 yrs of age, SDCSI, PFRT
1252698|NCT00085735|B5|Baseline|Arm V (8-21 Years of Age, SDCSI, IFRT)|Eligible patients 8-21 yrs of age, SDCSI, IFRT
1252699|NCT00085735|B4|Baseline|Arm IV (3-7 Years of Age, SDCSI, PFRT)|Eligible patients 3-7 yrs of age, SDCSI, PFRT
1252700|NCT00085735|B3|Baseline|Arm III (3-7 Years of Age, SDCSI, IFRT)|Eligible patients 3-7 yrs of age, SDCSI, IFRT
1252701|NCT00085735|B2|Baseline|Arm II (3-7 Years of Age, LDCSI, PFRT)|Eligible patients 3-7 yrs of age, LDCSI, PFRT
1252702|NCT00085735|B1|Baseline|Arm I (3-7 Years of Age, LDCSI, IFRT)|Eligible patients 3-7 yrs of age, LDCSI, IFRT
1252703|NCT00085735|P6|Participant Flow|Arm VI (8-21 Yrs of Age, SDCSI, PFRT)|Patients 8-21 yrs of age, SDCSI, PFRT
1252704|NCT00085735|P5|Participant Flow|Arm V (8-21 Yrs of Age, SDCSI, IFRT)|Patients 8-21 years of age, SDCSI, IFRT
1252705|NCT00085735|P4|Participant Flow|Arm IV (3-7 Yrs of Age, SDCSI, PFRT)|Patients 3-7 years of age, SDCSI, PFRT
1252706|NCT00085735|P3|Participant Flow|Arm III (3-7 Yrs of Age, SDCSI, IFRT)|Patients 3-7 years of age, SDCSI, IFRT
1252707|NCT00085735|P2|Participant Flow|Arm II (3-7 Yrs of Age, LDCSI, PFRT)|Patients 3-7 years of age, LDCSI, PFRT
1252708|NCT00085735|P1|Participant Flow|Arm I (3-7 Yrs of Age, LDCSI, IFRT)|Patients 3-7 years of age, LDCSI, IFRT
1252709|NCT00085735|O2|Outcome|Posterior Fossa Radiation (PFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (Treatment Arms II, IV, VI).
1252710|NCT00085735|O1|Outcome|Involved Field Radiation (IFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (Treatment Arms I, III, V).
1252711|NCT00085735|O2|Outcome|Standard-dose Craniospinal Radiation (SDCSI)|Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Treatment Arms III or IV)
1252712|NCT00085735|O1|Outcome|Low-dose Craniospinal Radiation (LDSCI)|Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Treatment Arms I or II)
1252713|NCT00085735|O2|Outcome|Posterior Fossa Radiation (PFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (Treatment Arms II, IV, VI).
1252714|NCT00085735|O1|Outcome|Involved Field Radiation (IFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (Treatment Arms I, III, V).
1252715|NCT00085735|O2|Outcome|Posterior Fossa Radiation (PFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (Treatment Arms II, IV, VI).
1252716|NCT00085735|O1|Outcome|Involved Field Radiation (IFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (Treatment Arms I, III, V)
1252717|NCT00085735|O2|Outcome|Posterior Fossa Radiation (PFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (Treatment Arms II, IV, VI)
1252718|NCT00085735|O1|Outcome|Involved Field Radiation (IFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (Treatment Arms I, III, V)
1252719|NCT00085735|O4|Outcome|Posterior Fossa Radiation (PFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (Treatment Arms II, IV, VI)
1252720|NCT00085735|O3|Outcome|Involved Field Radiation (IFRT)|Includes eligible patients 3-21 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (Treatment Arms I, III, V)
1252721|NCT00085735|O2|Outcome|Standard-dose Craniospinal Radiation (SDCSI)|Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Treatment Arms III or IV)
1252722|NCT00085735|O1|Outcome|Low-dose Craniospinal Radiation (LDSCI)|Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Treatment Arms I or II)
1252723|NCT00085735|O4|Outcome|Posterior Fossa Radiation (PFRT)|Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the PFRT arms (II, IV, VI).
1252804|NCT00085566|B4|Baseline|Total|Total of all reporting groups
1252724|NCT00085735|O3|Outcome|Involved Field Radiation (IFRT)|Includes eligible patients without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the IFRT arms (I, III, V).
1252725|NCT00085735|O2|Outcome|Standard-dose Craniospinal Radiation (SDCSI)|Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the SDCSI arms (Arms III and IV)
1252726|NCT00085735|O1|Outcome|Low-dose Craniospinal Radiation (LDSCI)|Includes eligible patients 3-7 years of age without anaplastic histology or evidence of disseminated or ERD based on central review and randomized to one of the LDCSI arms (Arms I and II)
1252727|NCT00085735|E6|Reported Event|Arm VI (8-21 Years of Age, SDCSI, PFRT)|"See Detailed Description (Arm VI)~Cisplatin: Given IV~Craniospinal Irradiation: Undergo craniospinal Irradiation~Cyclophosphamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Lomustine: Given orally~Quality-of-Life Assessment: Ancillary studies~Radiation Therapy: Undergo standard volume boost (whole posterior fossa radiation therapy)~Vincristine Sulfate: Given IV"
1252728|NCT00085735|E5|Reported Event|Arm V (8-21 Years of Age, SDCSI, IFRT)|"See Detailed Description (Arm V)~Cisplatin: Given IV~Craniospinal Irradiation: Undergo craniospinal Irradiation~Cyclophosphamide: Given IV~Involved-Field Radiation Therapy: Undergo smaller volume boost (involved-field radiation therapy)~Laboratory Biomarker Analysis: Correlative studies~Lomustine: Given orally~Quality-of-Life Assessment: Ancillary studies~Vincristine Sulfate: Given IV"
1252729|NCT00085735|E4|Reported Event|Arm IV (3-7 Years of Age, SDCSI, PFRT)|"See Detailed Description (Arm IV)~Craniospinal Irradiation: Undergo craniospinal Irradiation~Cyclophosphamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Lomustine: Given orally~Quality-of-Life Assessment: Ancillary studies~Radiation Therapy: Undergo standard volume boost (whole posterior fossa radiation therapy)~Vincristine Sulfate: Given IV"
1252771|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252772|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252730|NCT00085735|E3|Reported Event|Arm III (3-7 Years of Age, SDCSI, IFRT)|"See Detailed Description (Arm III)~Cisplatin: Given IV~Craniospinal Irradiation: Undergo craniospinal Irradiation~Cyclophosphamide: Given IV~Involved-Field Radiation Therapy: Undergo smaller volume boost (involved-field radiation therapy)~Laboratory Biomarker Analysis: Correlative studies~Lomustine: Given orally~Quality-of-Life Assessment: Ancillary studies~Vincristine Sulfate: Given IV"
1252731|NCT00085735|E2|Reported Event|Arm II (3-7 Years of Age, LDCSI, PFRT)|"See Detailed Description (Arm II)~Cisplatin: Given IV~Craniospinal Irradiation: Undergo craniospinal Irradiation~Cyclophosphamide: Given IV~Laboratory Biomarker Analysis: Correlative studies~Lomustine: Given orally~Quality-of-Life Assessment: Ancillary studies~Radiation Therapy: Undergo standard volume boost (whole posterior fossa radiation therapy)~Vincristine Sulfate: Given IV"
1252732|NCT00085735|E1|Reported Event|Arm I (3-7 Years of Age, LDCSI, IFRT)|"See Detailed Description (Arm I)~Cisplatin: Given IV~Craniospinal Irradiation: Undergo craniospinal Irradiation~Cyclophosphamide: Given IV~Involved-Field Radiation Therapy: Undergo smaller volume boost (involved-field radiation therapy)~Laboratory Biomarker Analysis: Correlative studies~Lomustine: Given orally~Quality-of-Life Assessment: Ancillary studies~Vincristine Sulfate: Given IV"
1252733|NCT00085709|B3|Baseline|Total|Total of all reporting groups
1252734|NCT00085709|B2|Baseline|ARA-C+Daunomycin|ARA-C+Daunomycin
1252735|NCT00085709|B1|Baseline|Ara-C+Daunomycin+Mylotarg|Ara-C+Daunomycin+Mylotarg
1252736|NCT00085709|P2|Participant Flow|ARA-C+Daunomycin|Standard induction regimen of 7 days of Ara-C (cytosine arabinoside)and 3 days of daunomycin
1252737|NCT00085709|P1|Participant Flow|Ara-C+Daunomycin+Mylotarg|Gemtuzumab (GO) added to the standard induction regimen of 7 days of Ara-C (cytosine arabinoside)and 3 days of daunomycin
1252738|NCT00085709|O4|Outcome|Post-consolidation G.O.|For patients who remain in CR without relapse, patients may receive up to 3 doses of G.O. 28 days apart.
1252739|NCT00085709|O3|Outcome|Ara-C Consolidation|For patients who achieved a CR during induction, patients may receive up to 3 28 day cycles of treatment with Ara-C consolidation. Patients who relapse from CR are taken off protocol consolidation treatment.
1252740|NCT00085709|O2|Outcome|Ara-C+Daunomycin|A 21 day treatment cycle of Induction 7+3 with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission during the first cycle of treatment
1252741|NCT00085709|O1|Outcome|Ara-C+Daunomycin+Mylotarg|A 21 day treatment cycle of Induction 7+3+G.O. with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission (CR) during the first cycle of treatment
1252742|NCT00085709|O2|Outcome|Ara-C+Daunomycin+Mylotarg|A 21 day treatment cycle of Induction 7+3+G.O. with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission (CR) during the first cycle of treatment
1252743|NCT00085709|O1|Outcome|Ara-C+Daunomycin|A 21 day treatment cycle of Induction 7+3 with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission during the first cycle of treatment
1252744|NCT00085709|O2|Outcome|Post-consolidation Observation|Patients did not receive any post-consolidation therapy
1252745|NCT00085709|O1|Outcome|Post-consolidation GO|For patients who remain in CR without relapse, patients may receive up to 3 doses of G.O. 28 days apart.
1252746|NCT00085709|E4|Reported Event|Post-consolidation G.O.|For patients who remain in CR without relapse, patients may receive up to 3 doses of G.O. 28 days apart.
1252747|NCT00085709|E3|Reported Event|Ara-C Consolidation|For patients who achieved a CR during induction, patients may receive up to 3 28 day cycles of treatment with Ara-C consolidation. Patients who relapse from CR are taken off protocol consolidation treatment.
1252748|NCT00085709|E2|Reported Event|Induction 7 + 3|A 21 day treatment cycle of Induction 7+3 with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission during the first cycle of treatment
1252749|NCT00085709|E1|Reported Event|Induction 7 + 3 + G.O.|A 21 day treatment cycle of Induction 7+3+G.O. with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission (CR) during the first cycle of treatment
1252750|NCT00085644|B3|Baseline|Total|Total of all reporting groups
1252751|NCT00085644|B2|Baseline|Placebo|Subjects on placebo treatment received SC injection of matched placebo every other week.
1252752|NCT00085644|B1|Baseline|Adalimumab|Subjects on active treatment received SC injection of 40 mg adalimumab every other week.
1252754|NCT00085644|P2|Participant Flow|Placebo|Subjects on placebo treatment received SC injection of matched placebo every other week.
1252755|NCT00085644|P1|Participant Flow|Adalimumab|Subjects on active treatment received SC injection of 40 mg adalimumab every other week.
1252756|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252757|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252758|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252759|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252760|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252761|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252762|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252763|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252764|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252765|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252766|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252767|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252768|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252769|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252770|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252773|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252774|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252775|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252776|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252777|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252778|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252779|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252780|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252781|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252782|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252783|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252784|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252785|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252786|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252787|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252788|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252789|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252790|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
1252791|NCT00085644|O1|Outcome|Any Adalimumab|By duration of exposure to adalimumab 40 mg every other week, subcutaneous
1252792|NCT00085644|O2|Outcome|Placebo|Subjects on placebo treatment received SC injection of matched placebo every other week.
1252793|NCT00085644|O1|Outcome|Adalimumab|Subjects on active treatment received SC injection of 40 mg adalimumab every other week.
1252794|NCT00085644|E1|Reported Event|Any Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
1252795|NCT00085631|B1|Baseline|Overall Study|Due to integrity issues with the current data, baseline measurements of age and gender are reported for the entire cohort, rather than by treatment arm. Age and gender information were available in the current documentation for all 101 patients in this study.
1252796|NCT00085631|P3|Participant Flow|Chemoradiation + Hyperthermia|"Patients in this arm were randomized to receive cisplatin chemotherapy and radiation therapy, together with hyperthermia therapy. Completed patients were those who had documented response or follow-up data in the current dataset."
1252797|NCT00085631|P2|Participant Flow|Chemoradiation|"Patients in this arm were randomized to receive cisplatin chemotherapy and radiation therapy, without hyperthermia therapy. Completed patients were those who had documented response or follow-up data in the current dataset."
1252798|NCT00085631|P1|Participant Flow|Unavailable|"Unavailable refers to patients who were randomized into one of the two treatment groups, but whose assignment could not be deduced from the current data. Completed patients were those who had documented response or follow-up data in the current dataset."
1252799|NCT00085631|O1|Outcome|Overall Study|Due to integrity issues with the current documented data, results are not reported for the 5-year overall survival rate in this study.
1252800|NCT00085631|O1|Outcome|Overall Study|Due to integrity issues with the current documented data, results are not reported for the 5-year local recurrence-free survival rate in this study.
1252801|NCT00085631|O1|Outcome|Overall Study|Due to integrity issues with the current documented data, results are not reported for the 5-year failure-free survival rate in this study.
1252802|NCT00085631|O1|Outcome|Overall Study|Due to integrity issues with the current documented data, results are not reported for the primary tumor response rate in this study.
1252803|NCT00085631|E1|Reported Event|Overall Study|Patients from both arms were combined in adverse event reporting.
1252805|NCT00085566|B3|Baseline|RAD 001 70 mg|70 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
1252806|NCT00085566|B2|Baseline|RAD 001 50 mg|50 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
1252807|NCT00085566|B1|Baseline|RAD 001 30 mg|30 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
1252808|NCT00085566|P3|Participant Flow|RAD 001 70 mg|70 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
1252809|NCT00085566|P2|Participant Flow|RAD 001 50 mg|50 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
1252810|NCT00085566|P1|Participant Flow|RAD 001 30 mg|30 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
1252811|NCT00085566|O3|Outcome|RAD 001 70 mg|70 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
1252812|NCT00085566|O2|Outcome|RAD 001 50 mg|50 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
1252813|NCT00085566|O1|Outcome|RAD 001 30 mg|30 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
1252814|NCT00085566|E3|Reported Event|RAD 001 70 mg|70 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
1252815|NCT00085566|E2|Reported Event|RAD 001 50 mg|50 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
1252816|NCT00085566|E1|Reported Event|RAD 001 30 mg|30 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
1252817|NCT00085540|B3|Baseline|Total|Total of all reporting groups
1252818|NCT00085540|B2|Baseline|Phase 2 Dose From Phase 1 - Romidepsin|"Patients receive FR901228 (romidepsin) as in phase I at dose level 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity~Romidepsin (depsipeptide): 13.3mg/m2~depsipeptide: Given IV"
1252819|NCT00085540|B1|Baseline|Phase 1 Dose Escalation - Romidepsin|"Patients receive FR901228 (romidepsin) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Dose escalation two dose levels:~Romidepsin (depsipeptide): 13.3mg/m2 and 17.7mg/m2~Pharmacokinetics~depsipeptide: Given IV"
1252820|NCT00085540|P2|Participant Flow|Phase 2 Dose From Phase 1 - Romidepsin|"Patients receive FR901228 (romidepsin) as in phase I at dose level 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity~Romidepsin (depsipeptide): 13.3mg/m2~depsipeptide: Given IV"
1252821|NCT00085540|P1|Participant Flow|Phase 1 Dose Escalation - Romidepsin|"Patients receive FR901228 (romidepsin) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Dose escalation two dose levels:~Romidepsin (depsipeptide): 13.3mg/m2 and 17.7mg/m2~Pharmacokinetics~depsipeptide: Given IV"
1252822|NCT00085540|O1|Outcome|Phase 2 Dose From Phase 1 - Romidepsin|"Patients receive FR901228 (romidepsin) as in phase I at dose level 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity~Romidepsin (depsipeptide): 13.3mg/m2~depsipeptide: Given IV"
1252823|NCT00085540|O1|Outcome|Phase 2 Dose From Phase 1 - Romidepsin|"Patients receive FR901228 (romidepsin) as in phase I at dose level 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity~Romidepsin (depsipeptide): 13.3mg/m2~depsipeptide: Given IV"
1252824|NCT00085540|O1|Outcome|Phase 1 Dose Escalation - Romidepsin|"Patients receive FR901228 (romidepsin) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Dose escalation two dose levels:~Romidepsin (depsipeptide): 13.3mg/m2 and 17.7mg/m2~Pharmacokinetics~depsipeptide: Given IV"
1252825|NCT00085540|E2|Reported Event|Phase 2 Dose From Phase 1 - Romidepsin|"Patients receive FR901228 (romidepsin) as in phase I at dose level 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity~Romidepsin (depsipeptide): 13.3mg/m2~depsipeptide: Given IV"
1252826|NCT00085540|E1|Reported Event|Phase 1 Dose Escalation - Romidepsin|"Patients receive FR901228 (romidepsin) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Dose escalation two dose levels:~Romidepsin (depsipeptide): 13.3mg/m2 and 17.7mg/m2~Pharmacokinetics~depsipeptide: Given IV"
1252827|NCT00085436|B1|Baseline|Treatment|All patients will be treated with autologous peripheral blood mononuclear cell-derived dendritic cells (DC) loaded with autologous tumor lysate (termed DC vaccine) administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and IFNα-2a. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.
1252828|NCT00085436|P1|Participant Flow|Treatment|All patients will be treated with autologous peripheral blood mononuclear cell-derived dendritic cells (DC) loaded with autologous tumor lysate (termed DC vaccine) administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and IFNα-2a. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.
1252829|NCT00085436|O1|Outcome|Treatment|All patients will be treated with autologous peripheral blood mononuclear cell-derived dendritic cells (DC) loaded with autologous tumor lysate (termed DC vaccine) administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and IFNα-2a. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.
1252830|NCT00085436|E1|Reported Event|Treatment|All patients will be treated with autologous peripheral blood mononuclear cell-derived dendritic cells (DC) loaded with autologous tumor lysate (termed DC vaccine) administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and IFNα-2a. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.
1252831|NCT00085423|B1|Baseline|Lymphodepleting Chemotherapy + High Dose IL-2|intravenous cyclophosphamide (60 mg/kg, days 1 and 2) and fludarabine (25 mg/m(2), day 3 through 7) followed by two 5-day courses of intravenous high-dose bolus IL-2 (600,000 U/kg; days 8 through 12 and 21 through 25). GM-CSF (250 microg/m(2)/d beginning day 8) was given until granulocyte recovery.
1252832|NCT00085423|P1|Participant Flow|Lymphodepleting Chemotherapy + High Dose Interleukin-2|"Lymphodepleting chemotherapy + high dose interleukin-2:~Intravenous cyclophosphamide (60 mg/kg, days 1 and 2) and fludarabine (25 mg/m(2), day 3 through 7) followed by two 5-day courses of intravenous high-dose bolus IL-2 (600,000 U/kg; days 8 through 12 and 21 through 25). Granulocyte-macrophage colony-stimulating factor, GM-CSF, (250 microg/m(2)/d beginning day 8) was given until granulocyte recovery."
1252833|NCT00085423|O1|Outcome|Group 1|all patients are treated with lymphodepleting chemotherapy and highdose IL-2 and GM-CSF.
1252834|NCT00085423|O1|Outcome|Group 1|all patients are treated with lymphodepleting chemotherapy and highdose IL-2 and GM-CSF.
1252835|NCT00085423|O1|Outcome|Group 1|all patients are treated with lymphodepleting chemotherapy and highdose IL-2 and GM-CSF.
1252836|NCT00085423|E1|Reported Event|Group 1|all patients are treated with lymphodepleting chemotherapy and highdose IL-2 and GM-CSF.
1252837|NCT00085410|B1|Baseline|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
1252838|NCT00085410|P1|Participant Flow|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
1252839|NCT00085410|O1|Outcome|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
1252840|NCT00085410|O1|Outcome|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
1252841|NCT00085410|O1|Outcome|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
1252842|NCT00085410|O1|Outcome|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
1252843|NCT00085410|O1|Outcome|Arm I|"Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.~bortezomib: Given IV"
1252844|NCT00085410|O1|Outcome|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
1252845|NCT00085410|O1|Outcome|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
1252846|NCT00085410|O1|Outcome|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
1252847|NCT00085410|O1|Outcome|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
1252848|NCT00085410|O1|Outcome|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
1252849|NCT00085410|O1|Outcome|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
1252850|NCT00085410|E1|Reported Event|Arm I|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
1252851|NCT00085293|B1|Baseline|Treatment|"Decitabine intravenous (IV) over 1 hour on days 1-5 and 8-12 of weeks 1 and 2 (course 1). Week 3, Iodine I 131 (131I) scanning using thyrotropin alfa injections. Participants whose scan do not demonstrate iodine uptake continue suppressive thyroid hormone therapy but no further study therapy; these participants who do show uptake undergo thyroid hormone withdrawal on weeks 4-8 and second course of decitabine (as in course 1) on weeks 7 and 8, with 131I therapy on week 9.~Decitabine: Starting dose 6 mg/m^2 intravenously over 1 hour every day for 5 successive days for 2 weeks (10 doses), with possible second course.~Iodine I 131: Undergo thyrotropin-alfa stimulated radioactive iodine scan~Recombinant thyrotropin alfa: Undergo thyrotropin-alfa stimulated radioactive iodine scan"
1252852|NCT00085293|P1|Participant Flow|Treatment|"Decitabine intravenous (IV) over 1 hour on days 1-5 and 8-12 of weeks 1 and 2 (course 1). Week 3, Iodine I 131 (131I) scanning using thyrotropin alfa injections. Participants whose scan do not demonstrate iodine uptake continue suppressive thyroid hormone therapy but no further study therapy; these participants who do show uptake undergo thyroid hormone withdrawal on weeks 4-8 and second course of decitabine (as in course 1) on weeks 7 and 8, with 131I therapy on week 9.~Decitabine: Starting dose 6 mg/m^2 intravenously over 1 hour every day for 5 successive days for 2 weeks (10 doses), with possible second course.~Iodine I 131: Undergo thyrotropin-alfa stimulated radioactive iodine scan~Recombinant thyrotropin alfa: Undergo thyrotropin-alfa stimulated radioactive iodine scan"
1252853|NCT00085293|O1|Outcome|Treatment|"Decitabine intravenous (IV) over 1 hour on days 1-5 and 8-12 of weeks 1 and 2 (course 1). Week 3, Iodine I 131 (131I) scanning using thyrotropin alfa injections. Participants whose scan do not demonstrate iodine uptake continue suppressive thyroid hormone therapy but no further study therapy; these participants who do show uptake undergo thyroid hormone withdrawal on weeks 4-8 and second course of decitabine (as in course 1) on weeks 7 and 8, with 131I therapy on week 9.~Decitabine: Starting dose 6 mg/m^2 intravenously over 1 hour every day for 5 successive days for 2 weeks (10 doses), with possible second course.~Iodine I 131: Undergo thyrotropin-alfa stimulated radioactive iodine scan~Recombinant thyrotropin alfa: Undergo thyrotropin-alfa stimulated radioactive iodine scan"
1252854|NCT00085293|O1|Outcome|Treatment|"Decitabine intravenous (IV) over 1 hour on days 1-5 and 8-12 of weeks 1 and 2 (course 1). Week 3, Iodine I 131 (131I) scanning using thyrotropin alfa injections. Participants whose scan do not demonstrate iodine uptake continue suppressive thyroid hormone therapy but no further study therapy; these participants who do show uptake undergo thyroid hormone withdrawal on weeks 4-8 and second course of decitabine (as in course 1) on weeks 7 and 8, with 131I therapy on week 9.~Decitabine: Starting dose 6 mg/m^2 intravenously over 1 hour every day for 5 successive days for 2 weeks (10 doses), with possible second course.~Iodine I 131: Undergo thyrotropin-alfa stimulated radioactive iodine scan~Recombinant thyrotropin alfa: Undergo thyrotropin-alfa stimulated radioactive iodine scan"
1252855|NCT00085293|E1|Reported Event|Treatment|"Decitabine intravenous (IV) over 1 hour on days 1-5 and 8-12 of weeks 1 and 2 (course 1). Week 3, Iodine I 131 (131I) scanning using thyrotropin alfa injections. Participants whose scan do not demonstrate iodine uptake continue suppressive thyroid hormone therapy but no further study therapy; these participants who do show uptake undergo thyroid hormone withdrawal on weeks 4-8 and second course of decitabine (as in course 1) on weeks 7 and 8, with 131I therapy on week 9.~Decitabine: Starting dose 6 mg/m^2 intravenously over 1 hour every day for 5 successive days for 2 weeks (10 doses), with possible second course.~Iodine I 131: Undergo thyrotropin-alfa stimulated radioactive iodine scan~Recombinant thyrotropin alfa: Undergo thyrotropin-alfa stimulated radioactive iodine scan"
1252856|NCT00085254|B4|Baseline|Total|Total of all reporting groups
1252857|NCT00085254|B3|Baseline|Arm 3 - Phase 2 (Treatment 2)|"INITIATION COURSE: Patients receive cilengitide (2000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (2000mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1253027|NCT00084318|O2|Outcome|RT + Docetaxel + Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
1252858|NCT00085254|B2|Baseline|Arm 2 - Phase 2 (Treatment 1)|"INITIATION COURSE: Patients receive cilengitide (500mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (500mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1252859|NCT00085254|B1|Baseline|Arm 1 - Safety Run In|"INITIATION COURSE: Patients receive cilengitide IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1252869|NCT00085254|O3|Outcome|Arm 3 2000mg (Safety Run-In)|"INITIATION COURSE: Patients receive cilengitide 2000 mg IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~Doses of cilengitide: 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~DLT defined as: Known TMZ hematological toxicities will not be considered dose limiting.~Nonhematological toxicities Grades 3-4 severity (except nausea and vomiting without sufficient antiemetic prophylaxis)"
1252860|NCT00085254|P3|Participant Flow|Arm 3 - Phase II (Treatment 2)|"INITIATION COURSE: Patients receive cilengitide (2000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV (2000mg) on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cilengitide,Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1252861|NCT00085254|P2|Participant Flow|Arm 2 - Phase II (Treatment 1)|"INITIATION COURSE: Patients receive cilengitide (500mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV (500mg) on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cilengitide, Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1252862|NCT00085254|P1|Participant Flow|Arm 1 (Safety Run In)|"INITIATION COURSE: Patients receive cilengitide IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1252863|NCT00085254|O1|Outcome|Arm 4 (Overall Study)|"INITIATION COURSE: Patients receive cilengitide IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1252864|NCT00085254|O2|Outcome|Arm 2 - Phase 2 (2000mg)|"INITIATION COURSE: Patients receive cilengitide (2000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (2000mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1252865|NCT00085254|O1|Outcome|Arm 1- Phase 2 (500mg)|"INITIATION COURSE: Patients receive cilengitide (500mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (500mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1254346|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
1252866|NCT00085254|O2|Outcome|Arm 2 - Phase 2 (Treatment 2)|"INITIATION COURSE: Patients receive cilengitide (2000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (2000mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1252867|NCT00085254|O1|Outcome|Arm 1 - Phase 2 (Treatment 1)|"INITIATION COURSE: Patients receive cilengitide (500mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (500mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1252868|NCT00085254|O1|Outcome|Arm 1 - Safety Run In|"INITIATION COURSE: Patients receive cilengitide IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1252870|NCT00085254|O2|Outcome|ARM 2 1000mg (Safety run-in)|"INITIATION COURSE: Patients receive cilengitide 1000 mg IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~Doses of cilengitide: 1000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~DLT defined as: Known TMZ hematological toxicities will not be considered dose limiting.~Nonhematological toxicities Grades 3-4 severity (except nausea and vomiting without sufficient antiemetic prophylaxis)"
1252871|NCT00085254|O1|Outcome|Arm 1 500mg (Safety Run In)|"INITIATION COURSE: Patients receive cilengitide 500 mg IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~Doses of cilengitide: 500mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~DLT defined as: Known TMZ hematological toxicities will not be considered dose limiting.~Nonhematological toxicities Grades 3-4 severity (except nausea and vomiting without sufficient antiemetic prophylaxis)"
1252872|NCT00085254|E3|Reported Event|Dose 2000|"INITIATION COURSE: Patients receive cilengitide (2000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (2000mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1252873|NCT00085254|E2|Reported Event|Dose 1000|"INITIATION COURSE: Patients receive cilengitide (1000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (2000mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1252874|NCT00085254|E1|Reported Event|Dose 500|"INITIATION COURSE: Patients receive cilengitide (500mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (500mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1252875|NCT00085202|B3|Baseline|Total|Total of all reporting groups
1252876|NCT00085202|B2|Baseline|High-Risk Group|Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm^2) at the primary site after surgery.
1252877|NCT00085202|B1|Baseline|Average-Risk Group|Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa (or supratentorial compartment for PNET's/ATRT). Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was <1.5 cm^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size <1.5 cm^2).
1252878|NCT00085202|P2|Participant Flow|High-Risk Group|Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm^2) at the primary site after surgery.
1252879|NCT00085202|P1|Participant Flow|Average-Risk Group|Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa (or supratentorial compartment for PNET's/ATRT). Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was <1.5 cm^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size <1.5 cm^2).
1252880|NCT00085202|O4|Outcome|ERBB2 Negative & High Risk|14 participants who were ERBB2 negative and in the high risk group
1252881|NCT00085202|O3|Outcome|ERBB2 Negative & Average Risk|31 participants who were ERBB2 negative and in the average risk group
1252882|NCT00085202|O2|Outcome|ERBB2 Positive & High Risk|23 participants who were ERBB2 positive and in the high risk group
1252883|NCT00085202|O1|Outcome|ERBB2 Positive & Average Risk|54 participants who were ERBB2 positive and in the average risk group.
1252884|NCT00085202|O3|Outcome|High-Risk Group|Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm^2) at the primary site after surgery.
1252885|NCT00085202|O2|Outcome|Average-Risk Group|Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa. Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was <1.5 cm^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size <1.5 cm^2).
1252906|NCT00084864|P1|Participant Flow|Arm 1|"Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.~calcitriol: Given orally~dexamethasone: Given orally"
1252886|NCT00085202|O1|Outcome|Overall Study|Analysis included the first 122 participants with a diagnosis of medulloblastoma and with fresh tissue and ERBB2 protein assessments. Participants with a diagnosis of supratentorial primitive neuroectodermal tumor (PNET), PNET variants (ependymoblastoma, pineoblastoma, CNS neuroblastoma), or atypical teratoid rhabdoid tumor (ATRT) were not included in the analysis of ERBB2 tumors.
1252887|NCT00085202|E2|Reported Event|High-Risk Group|Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm^2) at the primary site after surgery.
1252888|NCT00085202|E1|Reported Event|Average-Risk Group|Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa (or supratentorial compartment for PNET's/ATRT). Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was <1.5 cm^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size <1.5 cm^2).
1252889|NCT00085098|B3|Baseline|Total|Total of all reporting groups
1252890|NCT00085098|B2|Baseline|Regimen B (Chemotherapy Plus Radiotherapy)|"Courses 1 and 2: Patients receive carboplatin IV over 1 hour on days 1 and 2 and etoposide IV over 2 hours on days 1-3. Treatment repeats every 21 days for 2 courses.~Within 3 weeks of completing chemotherapy, patients with CR undergo low-dose radiation therapy 5 days a week for 5 weeks. Patients with MRD, a PR, or SD receive chemotherapy courses 3 and 4 as outlined below.~Courses 3 and 4: Patients receive cisplatin IV over 6 hours on day 1, cyclophosphamide IV over 1 hour on days 2 and 3, and filgrastim (G-CSF) SC or IV beginning on day 4 and continuing until blood counts recover.~Treatment repeats every 21 days for 2 courses. Patients achieving a CR or MRD proceed to reduced-dose radiotherapy. Patients with a PR, SD, or PD are restaged and may undergo standard radiation therapy as in regimen A.~Reduced-dose radiation therapy: Within 6 weeks of starting course 4, patients undergo lower-dose radiation therapy once daily on days 1-5 for 5 weeks"
1252891|NCT00085098|B1|Baseline|Regimen A (Radiotherapy Only)|Within 52 days of surgery, patients will undergo standard-dose radiation therapy 5 days a week for approximately 5-6 weeks.
1252892|NCT00085098|P2|Participant Flow|Regimen B (Chemotherapy Plus Radiotherapy)|Courses 1,2:Patients (PTS) receive carboplatin IV over 1 hour on days 1-2 and etoposide IV over 2 hours on days 1-3. Treatment repeats every 21 days for 2 courses. Within 3 weeks of completing chemotherapy, PTS with complete response (CR) undergo low-dose radiation therapy 5 days a week for 5 weeks. PTS with minimal residual disease (MRD), a PR, or stable disease (SD) receive chemotherapy courses 3,4. Courses 3,4:PTS receive cisplatin IV over 6 hours on day 1, cyclophosphamide IV over 1 hour on days 2-3 and filgrastim (G-CSF) subcutaneous (SC) or IV on day 4 continuing until blood counts recover. Treatment repeats every 21 days for 2 courses. PTS achieving a CR or MRD proceed to reduced-dose radiotherapy. PTS with a partial response (PR), SD or progressive disease (PD) are restaged and may undergo standard radiation therapy as in regimen A.Reduced-dose radiation therapy: Within 6 weeks of starting course 4, PTS undergo lower-dose radiation therapy once daily on days 1-5 for 5 weeks.
1252893|NCT00085098|P1|Participant Flow|Regimen A (Radiotherapy Only)|Within 52 days of surgery, patients will undergo standard-dose radiation therapy 5 days a week for approximately 5-6 weeks.
1252894|NCT00085098|O2|Outcome|Regimen B (Chemotherapy Plus Radiotherapy)|"Courses 1 and 2: Patients receive carboplatin IV over 1 hour on days 1 and 2 and etoposide IV over 2 hours on days 1-3. Treatment repeats every 21 days for 2 courses.~Within 3 weeks of completing chemotherapy, patients with CR undergo low-dose radiation therapy 5 days a week for 5 weeks. Patients with MRD, a PR, or SD receive chemotherapy courses 3 and 4 as outlined below.~Courses 3 and 4: Patients receive cisplatin IV over 6 hours on day 1, cyclophosphamide IV over 1 hour on days 2 and 3, and filgrastim (G-CSF) SC or IV beginning on day 4 and continuing until blood counts recover.~Treatment repeats every 21 days for 2 courses. Patients achieving a CR or MRD proceed to reduced-dose radiotherapy. Patients with a PR, SD, or PD are restaged and may undergo standard radiation therapy as in regimen A.~Reduced-dose radiation therapy: Within 6 weeks of starting course 4, patients undergo lower-dose radiation therapy once daily on days 1-5 for 5 weeks"
1252895|NCT00085098|O1|Outcome|Regimen A (Radiotherapy Only)|Within 52 days of surgery, patients will undergo standard-dose radiation therapy 5 days a week for approximately 5-6 weeks.
1252896|NCT00085098|E2|Reported Event|Regimen B (Chemotherapy Plus Radiotherapy)|"Courses 1 and 2: Patients receive carboplatin IV over 1 hour on days 1 and 2 and etoposide IV over 2 hours on days 1-3. Treatment repeats every 21 days for 2 courses.~Within 3 weeks of completing chemotherapy, patients with CR undergo low-dose radiation therapy 5 days a week for 5 weeks. Patients with MRD, a PR, or SD receive chemotherapy courses 3 and 4 as outlined below.~Courses 3 and 4: Patients receive cisplatin IV over 6 hours on day 1, cyclophosphamide IV over 1 hour on days 2 and 3, and filgrastim (G-CSF) SC or IV beginning on day 4 and continuing until blood counts recover.~Treatment repeats every 21 days for 2 courses. Patients achieving a CR or MRD proceed to reduced-dose radiotherapy. Patients with a PR, SD, or PD are restaged and may undergo standard radiation therapy as in regimen A.~Reduced-dose radiation therapy: Within 6 weeks of starting course 4, patients undergo lower-dose radiation therapy once daily on days 1-5 for 5 weeks"
1252897|NCT00085098|E1|Reported Event|Regimen A (Radiotherapy Only)|Within 52 days of surgery, patients will undergo standard-dose radiation therapy 5 days a week for approximately 5-6 weeks.
1252898|NCT00084864|B5|Baseline|Total|Total of all reporting groups
1252899|NCT00084864|B4|Baseline|Arm 4|"Patients receive oral calcitriol once daily on days 2-4.~calcitriol: Given orally"
1252900|NCT00084864|B3|Baseline|Arm 3|"Patients receive oral dexamethasone once daily on days 1-4.~dexamethasone: Given orally"
1252901|NCT00084864|B2|Baseline|Arm 2|"No study drugs before surgery.~clinical observation: No intervention before surgery"
1252902|NCT00084864|B1|Baseline|Arm 1|"Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.~calcitriol: Given orally~dexamethasone: Given orally"
1252903|NCT00084864|P4|Participant Flow|Arm 4|"Patients receive oral calcitriol once daily on days 2-4.~calcitriol: Given orally"
1252904|NCT00084864|P3|Participant Flow|Arm 3|"Patients receive oral dexamethasone once daily on days 1-4.~dexamethasone: Given orally"
1252905|NCT00084864|P2|Participant Flow|Arm 2|"No study drugs before surgery.~clinical observation: No intervention before surgery"
1252907|NCT00084864|O4|Outcome|Arm 4|"Patients receive oral calcitriol once daily on days 2-4.~calcitriol: Given orally"
1252908|NCT00084864|O3|Outcome|Arm 3|"Patients receive oral dexamethasone once daily on days 1-4.~dexamethasone: Given orally"
1252909|NCT00084864|O2|Outcome|Arm 2|"No study drugs before surgery.~clinical observation: No intervention before surgery"
1252910|NCT00084864|O1|Outcome|Arm 1|"Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.~calcitriol: Given orally~dexamethasone: Given orally"
1252911|NCT00084864|O4|Outcome|Arm 4|"Patients receive oral calcitriol once daily on days 2-4.~calcitriol: Given orally"
1252912|NCT00084864|O3|Outcome|Arm 3|"Patients receive oral dexamethasone once daily on days 1-4.~dexamethasone: Given orally"
1252913|NCT00084864|O2|Outcome|Arm 2|"No study drugs before surgery.~clinical observation: No intervention before surgery"
1252914|NCT00084864|O1|Outcome|Arm 1|"Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.~calcitriol: Given orally~dexamethasone: Given orally"
1252915|NCT00084864|O4|Outcome|Arm 4|"Patients receive oral calcitriol once daily on days 2-4.~calcitriol: Given orally"
1252916|NCT00084864|O3|Outcome|Arm 3|"Patients receive oral dexamethasone once daily on days 1-4.~dexamethasone: Given orally"
1252917|NCT00084864|O2|Outcome|Arm 2|"No study drugs before surgery.~clinical observation: No intervention before surgery"
1252918|NCT00084864|O1|Outcome|Arm 1|"Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.~calcitriol: Given orally~dexamethasone: Given orally"
1252919|NCT00084864|O4|Outcome|Arm 4|"Patients receive oral calcitriol once daily on days 2-4.~calcitriol: Given orally"
1252920|NCT00084864|O3|Outcome|Arm 3|"Patients receive oral dexamethasone once daily on days 1-4.~dexamethasone: Given orally"
1252921|NCT00084864|O2|Outcome|Arm 2|"No study drugs before surgery.~clinical observation: No intervention before surgery"
1252922|NCT00084864|O1|Outcome|Arm 1|"Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.~calcitriol: Given orally~dexamethasone: Given orally"
1252923|NCT00084864|O4|Outcome|Arm 4|"Patients receive oral calcitriol once daily on days 2-4.~calcitriol: Given orally"
1252924|NCT00084864|O3|Outcome|Arm 3|"Patients receive oral dexamethasone once daily on days 1-4.~dexamethasone: Given orally"
1252925|NCT00084864|O2|Outcome|Arm 2|"No study drugs before surgery.~clinical observation: No intervention before surgery"
1252926|NCT00084864|O1|Outcome|Arm 1|"Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.~calcitriol: Given orally~dexamethasone: Given orally"
1252927|NCT00084864|E4|Reported Event|Arm 4|"Patients receive oral calcitriol once daily on days 2-4.~calcitriol: Given orally"
1252928|NCT00084864|E3|Reported Event|Arm 3|"Patients receive oral dexamethasone once daily on days 1-4.~dexamethasone: Given orally"
1252929|NCT00084864|E2|Reported Event|Arm 2|"No study drugs before surgery.~clinical observation: No intervention before surgery"
1252930|NCT00084864|E1|Reported Event|Arm 1|"Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.~calcitriol: Given orally~dexamethasone: Given orally"
1252931|NCT00084838|B1|Baseline|Multi-agent Intrathecal & Systemic CT w/ RT (Modified IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51) Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine,and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively."
1253028|NCT00084318|O1|Outcome|RT + Cisplatin + Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
1252932|NCT00084838|P1|Participant Flow|Multi-agent Intrathecal and Systemic CT With RT (Modified IRS|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51) Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively."
1252933|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
1252963|NCT00084617|P1|Participant Flow|Treatment (Oxaliplatin, Irinotecan, Capecitabine)|Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
1252997|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
1252934|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
1252935|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
1252936|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
1252937|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
1252978|NCT00084409|B1|Baseline|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
1252979|NCT00084409|P2|Participant Flow|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
1252980|NCT00084409|P1|Participant Flow|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
1253029|NCT00084318|E2|Reported Event|RT+Docetaxel+Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
1252938|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
1252939|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
1252940|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
1252995|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
1253677|NCT00080288|P2|Participant Flow|Placebo|Matching placebo tablets once daily
1252941|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
1252942|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
1252943|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
1252944|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
1252945|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
1252946|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
1252947|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
1252996|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
1254033|NCT00078377|P3|Participant Flow|Placebo|Matching placebo tablets once daily in the morning
1252948|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
1252949|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively."
1252950|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Modified IRS|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51) Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively."
1252951|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Modified IRS|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51) Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively."
1252952|NCT00084838|E1|Reported Event|Multi-agent Intrathecal & Systemic CT w/ RT (Modified IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51) Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine,and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively."
1252953|NCT00084747|B1|Baseline|Bortezomib|bortezomib administration beginning 3-4 month after the day of transplantation after resolution of bone marrow transplant toxicities
1252954|NCT00084747|P1|Participant Flow|Bortezomib|bortezomib administration beginning 3-4 month after the day of transplantation after resolution of bone marrow transplant toxicities
1252955|NCT00084747|O1|Outcome|Bortezomib|bortezomib
1252956|NCT00084747|O1|Outcome|Bortezomib|autologous peripheral blood progenitor cell transplantation with bortezomib maintenance as treatment for intermediate-and advanced-stage multiple myeloma
1252957|NCT00084747|E1|Reported Event|Bortezomib|bortezomib administration beginning 3-4 month after the day of transplantation after resolution of bone marrow transplant toxicities
1252958|NCT00084682|B1|Baseline|Treatment (Romidepsin)|"Patients receive FR901228 (depsipeptide) IV at 13 mg/m2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV"
1252959|NCT00084682|P1|Participant Flow|Treatment (Romidepsin)|"Patients receive FR901228 (depsipeptide) IV at 13 mg/m2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV"
1252960|NCT00084682|O1|Outcome|Treatment (Romidepsin)|"Patients receive FR901228 (depsipeptide) IV at 13 mg/m2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV"
1252961|NCT00084682|E1|Reported Event|Treatment (Romidepsin)|"Patients receive FR901228 (depsipeptide) IV at 13 mg/m2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV"
1252962|NCT00084617|B1|Baseline|Treatment (Oxaliplatin, Irinotecan, Capecitabine)|Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
1254034|NCT00078377|P2|Participant Flow|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
1252964|NCT00084617|O1|Outcome|Treatment (Oxaliplatin, Irinotecan, Capecitabine)|Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
1252965|NCT00084617|O1|Outcome|Treatment (Oxaliplatin, Irinotecan, Capecitabine)|Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
1252966|NCT00084617|O1|Outcome|Treatment (Oxaliplatin, Irinotecan, Capecitabine)|Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
1252967|NCT00084617|E1|Reported Event|Treatment (Oxaliplatin, Irinotecan, Capecitabine)|Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
1252968|NCT00084487|B1|Baseline|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~becatecarin : Given IV"
1252969|NCT00084487|P1|Participant Flow|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~becatecarin : Given IV"
1252970|NCT00084487|O1|Outcome|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~becatecarin : Given IV"
1252971|NCT00084487|O1|Outcome|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~becatecarin : Given IV"
1252972|NCT00084487|O1|Outcome|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~becatecarin : Given IV"
1252973|NCT00084487|O1|Outcome|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~becatecarin : Given IV"
1252974|NCT00084487|O1|Outcome|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~becatecarin : Given IV"
1252975|NCT00084487|E1|Reported Event|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~becatecarin : Given IV"
1252976|NCT00084409|B3|Baseline|Total|Total of all reporting groups
1252977|NCT00084409|B2|Baseline|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
1253079|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
1252981|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
1252982|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
1252983|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
1252984|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
1252985|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
1252986|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
1252987|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
1252988|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
1252989|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
1252990|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
1252991|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
1252992|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
1252993|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
1252994|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
1253098|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
1252998|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
1252999|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
1253000|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
1253001|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
1253002|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
1253003|NCT00084409|O2|Outcome|Placebo|
1253004|NCT00084409|O1|Outcome|Iloprost|
1253005|NCT00084409|E2|Reported Event|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
1253006|NCT00084409|E1|Reported Event|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
1253007|NCT00084383|B1|Baseline|GVAX Pancreatic Cancer Vaccine|
1253008|NCT00084383|P1|Participant Flow|GVAX Pancreatic Cancer Vaccine|
1253009|NCT00084383|O1|Outcome|GVAX Pancreatic Cancer Vaccine|
1253010|NCT00084383|O1|Outcome|GVAX Pancreatic Cancer Vaccine|
1253011|NCT00084383|E1|Reported Event|GVAX Pancreatic Cancer Vaccine|
1253012|NCT00084318|B3|Baseline|Total|Total of all reporting groups
1253013|NCT00084318|B2|Baseline|RT + Docetaxel + Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
1253014|NCT00084318|B1|Baseline|RT + Cisplatin + Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
1253015|NCT00084318|P2|Participant Flow|RT + Docetaxel + Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
1253016|NCT00084318|P1|Participant Flow|RT + Cisplatin + Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
1253017|NCT00084318|O2|Outcome|RT + Docetaxel + Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
1253018|NCT00084318|O1|Outcome|RT + Cisplatin + Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
1253019|NCT00084318|O2|Outcome|RT+Docetaxel+Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
1253020|NCT00084318|O1|Outcome|RT+Cisplatin+Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
1253021|NCT00084318|O2|Outcome|RT+Docetaxel+Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
1253022|NCT00084318|O1|Outcome|RT+Cisplatin+Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
1253023|NCT00084318|O2|Outcome|RT+Docetaxel+Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
1253024|NCT00084318|O1|Outcome|RT+Cisplatin+Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
1253025|NCT00084318|O2|Outcome|RT + Docetaxel + Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
1253026|NCT00084318|O1|Outcome|RT + Cisplatin + Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
1254347|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
1253030|NCT00084318|E1|Reported Event|RT+Cisplatin+Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
1253031|NCT00084266|B3|Baseline|Total|Total of all reporting groups
1253032|NCT00084266|B2|Baseline|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253033|NCT00084266|B1|Baseline|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253034|NCT00084266|P2|Participant Flow|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253035|NCT00084266|P1|Participant Flow|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253036|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253037|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253038|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253039|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253040|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253041|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253042|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253043|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253044|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253045|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253046|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253047|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253048|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253049|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253050|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253051|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253052|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253080|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
1253081|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
1253053|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253054|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253055|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253056|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253057|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253058|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253059|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253060|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253099|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
1253061|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253062|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253063|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253064|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253065|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253066|NCT00084266|E2|Reported Event|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253067|NCT00084266|E1|Reported Event|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
1253068|NCT00084136|B4|Baseline|Total|Total of all reporting groups
1253069|NCT00084136|B3|Baseline|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
1253070|NCT00084136|B2|Baseline|ddI+FTC+ATV|"ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine >~> On May 23, 2008, Arm B was closed following a planned interim review by the study's independent Data and Safety Monitoring Board (DSMB). The DSMB recommendation was based upon compelling evidence that Arm B had significantly more virologic failure (and therefore was inferior when) compared to Arm A. Participants still receiving Arm B medications were offered alternatives, and all participants continued to be followed."
1253071|NCT00084136|B1|Baseline|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
1253072|NCT00084136|P3|Participant Flow|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
1253073|NCT00084136|P2|Participant Flow|ddI+FTC+ATV|"ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine >~> On May 23, 2008, Arm B was closed following a planned interim review by the study's independent Data and Safety Monitoring Board (DSMB). The DSMB recommendation was based upon compelling evidence that Arm B had significantly more virologic failure (and therefore was inferior when) compared to Arm A. Participants still receiving Arm B medications were offered alternatives, and all participants continued to be followed."
1253074|NCT00084136|P1|Participant Flow|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
1253075|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
1253076|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
1253077|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
1253078|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
1253082|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
1253083|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
1253084|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
1253085|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
1253086|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
1253087|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
1253088|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
1253089|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
1253090|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
1253091|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
1253092|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
1253093|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
1253094|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
1253095|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
1253096|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
1253097|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
1253100|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
1253101|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
1253102|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
1253103|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
1253104|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
1253105|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
1253106|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
1253107|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
1253108|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
1253109|NCT00084136|O2|Outcome|ddI+FTC+ATV|"ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine >~> On May 23, 2008, Arm B was closed following a planned interim review by the study's independent Data and Safety Monitoring Board (DSMB). The DSMB recommendation was based upon compelling evidence that Arm B had significantly more virologic failure (and therefore was inferior when) compared to Arm A. Participants still receiving Arm B medications were offered alternatives, and all participants continued to be followed."
1253110|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
1253111|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
1253112|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
1253113|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
1253114|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
1253115|NCT00084136|O2|Outcome|ddI+FTC+ATV|"ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine >~> On May 23, 2008, Arm B was closed following a planned interim review by the study's independent Data and Safety Monitoring Board (DSMB). The DSMB recommendation was based upon compelling evidence that Arm B had significantly more virologic failure (and therefore was inferior when) compared to Arm A. Participants still receiving Arm B medications were offered alternatives, and all participants continued to be followed."
1253116|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
1253117|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
1253118|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
1253119|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
1253120|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
1253121|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
1253122|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
1253123|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
1253124|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
1253125|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
1253126|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
1253127|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
1253128|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
1253129|NCT00084136|E3|Reported Event|TDF/FTC+EFV|
1253130|NCT00084136|E2|Reported Event|ddI+FTC+ATV|
1253132|NCT00084084|B1|Baseline|Agalsidase Alfa (Cohort 1)|0.2 mg/kg agalsidase alfa infused by IV over 40 (+/- 10) minutes every other week
1253133|NCT00084084|P1|Participant Flow|Agalsidase Alfa (Cohort 1)|Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
1253134|NCT00084084|O1|Outcome|Agalsidase Alfa (Cohort 1)|Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
1253135|NCT00084084|O1|Outcome|Agalsidase Alfa (Cohort 1)|Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
1253136|NCT00084084|O1|Outcome|Agalsidase Alfa (Cohort 1)|Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
1253137|NCT00084084|O1|Outcome|Agalsidase Alfa (Cohort 1)|Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
1253138|NCT00084084|E2|Reported Event|Transition Safety Population|A subset of patients from the Safety Population RB who additionally received at least 1 dose of Replagal AF in Phase 2.
1253139|NCT00084084|E1|Reported Event|Safety Population RB|Patients in Cohort 1 who received at least 1 dose of Replagal RB in Phase 1 - no data from Phase 2 (Replagal AF) included.
1253140|NCT00083915|B3|Baseline|Total|Total of all reporting groups
1253141|NCT00083915|B2|Baseline|Mel-DT PACE|
1253142|NCT00083915|B1|Baseline|High Dose Melphalan|
1253143|NCT00083915|P2|Participant Flow|Mel-DT PACE|
1253144|NCT00083915|P1|Participant Flow|High Dose Melphalan|
1253145|NCT00083915|O2|Outcome|Mel-DT PACE|
1253146|NCT00083915|O1|Outcome|High Dose Melphalan|
1253147|NCT00083915|E2|Reported Event|Mel-DT PACE|
1253148|NCT00083915|E1|Reported Event|High Dose Melphalan|
1253150|NCT00083889|B2|Baseline|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
1253151|NCT00083889|B1|Baseline|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
1253152|NCT00083889|P2|Participant Flow|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
1253153|NCT00083889|P1|Participant Flow|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
1253154|NCT00083889|O1|Outcome|Total Drug: SU011248 and SU012662|SU011248 and active metabolite SU012662
1253155|NCT00083889|O1|Outcome|SU012662|Active metabolite of SU011248
1253156|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle. Intra-subject dose reduction to 35.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
1253157|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
1253158|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
1253159|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
1253160|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
1253161|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
1253162|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
1253163|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
1253164|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
1253165|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
1253166|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
1253167|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
1253168|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
1253169|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
1253170|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
1253171|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
1253172|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
1253173|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
1253174|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
1253175|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
1253176|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
1253177|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
1253178|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
1253179|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
1253180|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
1253181|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
1253182|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
1253183|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
1253184|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
1253185|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
1253186|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
1253187|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
1253188|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
1253189|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
1253190|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
1253191|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
1253192|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
1253193|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
1253194|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
1253195|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
1253236|NCT00083551|B1|Baseline|Thalidomide|Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance.
1253196|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
1253197|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
1253198|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
1253199|NCT00083889|E2|Reported Event|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
1253200|NCT00083889|E1|Reported Event|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
1253201|NCT00083759|B3|Baseline|Total|Total of all reporting groups
1253202|NCT00083759|B2|Baseline|Placebo|Placebo IV infusions + methotrexate (MTX)
1253203|NCT00083759|B1|Baseline|Natalizumab|Natalizumab 300 mg as monthly IV infusions + methotrexate (MTX)
1253204|NCT00083759|P2|Participant Flow|Placebo|Placebo IV infusions + methotrexate (MTX)
1253205|NCT00083759|P1|Participant Flow|Natalizumab|Natalizumab 300 mg as monthly IV infusions + methotrexate (MTX)
1253206|NCT00083759|O2|Outcome|Placebo|Placebo IV infusions + methotrexate (MTX)
1253207|NCT00083759|O1|Outcome|Natalizumab|Natalizumab 300 mg as monthly IV infusions + methotrexate (MTX)
1253208|NCT00083759|O2|Outcome|Placebo|Placebo IV infusions + methotrexate (MTX)
1253209|NCT00083759|O1|Outcome|Natalizumab|Natalizumab 300 mg as monthly IV infusions + methotrexate (MTX)
1253212|NCT00083720|B1|Baseline|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
1253213|NCT00083720|P1|Participant Flow|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
1253214|NCT00083720|O1|Outcome|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
1253215|NCT00083720|O1|Outcome|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
1253216|NCT00083720|O1|Outcome|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
1253217|NCT00083720|O1|Outcome|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
1253218|NCT00083720|O1|Outcome|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
1253219|NCT00083720|O1|Outcome|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
1253220|NCT00083720|O1|Outcome|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
1253221|NCT00083720|E1|Reported Event|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
1253222|NCT00083616|B1|Baseline|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
1253223|NCT00083616|P1|Participant Flow|Panitumumab (ABX-EGF)|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
1253224|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
1253225|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
1253226|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
1253227|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
1253228|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
1253229|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
1253230|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
1253231|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
1253232|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
1253233|NCT00083616|E1|Reported Event|Panitumumab|
1253234|NCT00083551|B3|Baseline|Total|Total of all reporting groups
1253235|NCT00083551|B2|Baseline|No Thalidomide|Patient received no thalidomide during induction, consolidation, and maintenance therapy.
1253237|NCT00083551|P2|Participant Flow|No Thalidomide|Patient received no thalidomide during induction, consolidation, and maintenance therapy.
1253238|NCT00083551|P1|Participant Flow|Thalidomide|Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance.
1253239|NCT00083551|O2|Outcome|No Thalidomide|Patient received no thalidomide during induction, consolidation, and maintenance therapy.
1253240|NCT00083551|O1|Outcome|Thalidomide|Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance.
1253241|NCT00083551|E2|Reported Event|No Thalidomide|Patient received no thalidomide during induction, consolidation, and maintenance therapy.
1253242|NCT00083551|E1|Reported Event|Thalidomide|Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance.
1253243|NCT00083382|B1|Baseline|Thalidomide + Bisphosphonate|200 mg/day Thalidomide + 90 mg Pamidronate OR 4 mg Zometa every 2 weeks for 2 months and then every 4 weeks as maintenance therapy
1253280|NCT00083122|O1|Outcome|Group 1 (Platin Resistant)|Patients receive 60 mg/m^2 cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
1253281|NCT00083122|O2|Outcome|Group 2 (Platin Sensitive)|Patients receive 60 mg/m^2cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
1253337|NCT00082407|O1|Outcome|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
1254035|NCT00078377|P1|Participant Flow|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
1253244|NCT00083382|P1|Participant Flow|Thalidomide + Bisphosphonate|"200 mg/day Thalidomide + 90 mg Pamidronate OR 4 mg Zometa every 2 weeks for 2 months and then every 4 weeks as maintenance therapy~Thalidomide: All Patients will receive thalidomide 200 mg as an oral once daily dose. Dose may be reduced to as low as 50 mg qod in the event of severe toxicity. Thalidomide will continue daily as tolerated until criteria to remove from study are met. Patients will receive appropriate regimen to prevent constipation (i.e., colace, dulcolax, milk of magnesia, or lactulose)~Pamidronate: Patients will receive either pamidronate or zometa. Pamidronate is administered at a dose of 90 mg by continuous infusion over 90 minutes, every two weeks for 2 months. Disease will be reassessed after two cycles. Those with stable disease or better will receive 90 mg every 4 weeks as maintenance therapy.~Zometa: Patients will receive either pamidronate or zometa. Zometa is administered at a dose of 4 mg by continuous infusion every two weeks for 2 months. Dise"
1253245|NCT00083382|O1|Outcome|Thalidomide + Bisphosphonate|200 mg/day Thalidomide + 90 mg Pamidronate OR 4 mg Zometa every 2 weeks for 2 months and then every 4 weeks as maintenance therapy
1253246|NCT00083382|E1|Reported Event|Thalidomide + Bisphosphonate|200 mg/day Thalidomide + 90 mg Pamidronate OR 4 mg Zometa every 2 weeks for 2 months and then every 4 weeks as maintenance therapy
1253247|NCT00083226|B1|Baseline|Treatment (Doxorubicin+Bortezomib)|"Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity.~doxorubicin: Given IV~bortezomib: Given IV"
1253248|NCT00083226|P1|Participant Flow|Treatment (Doxorubicin+Bortezomib)|"Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity.~doxorubicin: Given IV~bortezomib: Given IV"
1253249|NCT00083226|O1|Outcome|Treatment (Doxorubicin+Bortezomib)|"Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity.~doxorubicin: Given IV~bortezomib: Given IV"
1253250|NCT00083226|O1|Outcome|Treatment (Doxorubicin+Bortezomib)|"Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity.~doxorubicin: Given IV~bortezomib: Given IV"
1253251|NCT00083226|O1|Outcome|Treatment (Doxorubicin+Bortezomib)|"Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity.~doxorubicin: Given IV~bortezomib: Given IV"
1253252|NCT00083226|E1|Reported Event|Doxorubicin+Bortezomib|Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
1253253|NCT00083174|B3|Baseline|Total|Total of all reporting groups
1253254|NCT00083174|B2|Baseline|Placebo|one tablet daily in am
1253255|NCT00083174|B1|Baseline|Exemestane|one 25 mg tablet daily in am
1253256|NCT00083174|P2|Participant Flow|Placebo|one tablet daily in am
1253257|NCT00083174|P1|Participant Flow|Exemestane|one 25 mg tablet daily in am
1253258|NCT00083174|O2|Outcome|Placebo|one tablet daily in am
1253259|NCT00083174|O1|Outcome|Exemestane|one 25 mg tablet daily in am
1253260|NCT00083174|O2|Outcome|Placebo|one tablet daily in am
1253261|NCT00083174|O1|Outcome|Exemestane|one 25 mg tablet daily in am
1253262|NCT00083174|O2|Outcome|Placebo|one tablet daily in am
1253263|NCT00083174|O1|Outcome|Exemestane|one 25 mg tablet daily in am
1253264|NCT00083174|O2|Outcome|Placebo|one tablet daily in am
1253275|NCT00083122|B2|Baseline|Group 2 (Platin Sensitive)|Patients receive cisplatin IV over 2 hours and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
1253276|NCT00083122|B1|Baseline|Group 1 (Platin Resistant)|Patients receive cisplatin IV over 2 hours and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
1253277|NCT00083122|P2|Participant Flow|Group 2 (Platin Sensitive)|Patients receive 60 mg/m^2 of cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
1253278|NCT00083122|P1|Participant Flow|Group 1 (Platin Resistant)|Patients receive 60 mg/m^2 of cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
1253279|NCT00083122|O2|Outcome|Group 2 (Platin Sensitive)|Patients receive 60 mg/m^2 cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
1253282|NCT00083122|O1|Outcome|Group 1 (Platin Resistant)|Patients receive 60 mg/m^2 cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
1253283|NCT00083122|O2|Outcome|Group 2 (Platin Sensitive)|Patients receive 60 mg/m^2 cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
1253284|NCT00083122|O1|Outcome|Group 1 (Platin Resistant)|Patients receive 60 mg/m^2 cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
1253285|NCT00083122|E1|Reported Event|Group 1 and Group 2 Combined|Patients receive cisplatin IV over 2 hours and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
1253286|NCT00082888|B1|Baseline|R115777 (Tipifarnib)|300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician dicretion.
1253287|NCT00082888|P1|Participant Flow|R115777 (Tipifarnib)|300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician dicretion.
1253288|NCT00082888|O1|Outcome|R115777 (Tipifarnib)|300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician dicretion.
1253289|NCT00082888|E1|Reported Event|R115777 (Tipifarnib)|300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician dicretion.
1253290|NCT00082810|B1|Baseline|Fulvestrant 250 mg + Tipifarnib 300 mg|Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
1253291|NCT00082810|P1|Participant Flow|Fulvestrant 250 mg + Tipifarnib 300 mg|Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
1253292|NCT00082810|O1|Outcome|Fulvestrant 250 mg + Tipifarnib 300 mg|Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
1253293|NCT00082810|O1|Outcome|Fulvestrant 250 mg + Tipifarnib 300 mg|Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
1253294|NCT00082810|O1|Outcome|Fulvestrant 250 mg + Tipifarnib 300 mg|Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
1253295|NCT00082810|O1|Outcome|Fulvestrant 250 mg + Tipifarnib 300 mg|Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
1253296|NCT00082810|E1|Reported Event|Fulvestrant 250 mg + Tipifarnib 300 mg|Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
1253297|NCT00082758|B4|Baseline|Total|Total of all reporting groups
1253298|NCT00082758|B3|Baseline|Disease Identified by BM Immunohistochemistry Only|"Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning or BM histology, however, disease is identified and quantified by BM immunohistochemistry (>5 neuroblastoma cells per 1,000,000 nucleated marrow cells).~hu14.18-Interleukin-2 fusion protein : Given IV"
1253299|NCT00082758|B2|Baseline|Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning and/or by bone marrow histology.~hu14.18-Interleukin-2 fusion protein : Given IV"
1253300|NCT00082758|B1|Baseline|Disease Measurable by Standard Criteria(hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute.~hu14.18-Interleukin-2 fusion protein : Given IV"
1253301|NCT00082758|P3|Participant Flow|Disease Identified by BM Immunohistochemistry Only|"Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by meta-iodobenzylguanidine (MIBG) scanning or bone marrow (BM) histology, however, disease is identified and quantified by BM immunohistochemistry (>5 neuroblastoma cells per 1,000,000 nucleated marrow cells)~hu14.18-Interleukin-2 fusion protein : Given IV"
1253326|NCT00082433|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
1253302|NCT00082758|P2|Participant Flow|Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by meta-iodobenzylguanidine (MIBG) scanning and/or by bone marrow (BM) histology.~hu14.18-Interleukin-2 fusion protein : Given IV"
1253303|NCT00082758|P1|Participant Flow|Disease Measurable by Standard Criteria(hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute.~hu14.18-Interleukin-2 fusion protein : Given IV"
1253304|NCT00082758|O3|Outcome|Disease Identified by BM Immunohistochemistry Only|"Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning or BM histology, however, disease is identified and quantified by BM immunohistochemistry (>5 neuroblastoma cells per 1,000,000 nucleated marrow cells)~hu14.18-Interleukin-2 fusion protein : Given IV"
1253305|NCT00082758|O2|Outcome|Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by MIBG (meta-iodobenzylguanidine) scanning and/or by bone marrow histology.~hu14.18-Interleukin-2 fusion protein : Given IV"
1253306|NCT00082758|O1|Outcome|Disease Measurable by Standard Criteria(hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute.~hu14.18-Interleukin-2 fusion protein : Given IV"
1253307|NCT00082758|E3|Reported Event|Disease Identified by BM Immunohistochemistry Only|"Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning or BM histology, however, disease is identified and quantified by BM immunohistochemistry (>5 neuroblastoma cells per 1,000,000 nucleated marrow cells).~hu14.18-Interleukin-2 fusion protein : Given IV"
1253308|NCT00082758|E2|Reported Event|Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning and/or by bone marrow histology.~hu14.18-Interleukin-2 fusion protein : Given IV"
1253309|NCT00082758|E1|Reported Event|Disease Measurable by Standard Criteria(hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute.~hu14.18-Interleukin-2 fusion protein : Given IV"
1253310|NCT00082433|B3|Baseline|Total|Total of all reporting groups
1253311|NCT00082433|B2|Baseline|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
1253312|NCT00082433|B1|Baseline|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
1253313|NCT00082433|P2|Participant Flow|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
1253314|NCT00082433|P1|Participant Flow|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
1253315|NCT00082433|O2|Outcome|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
1253316|NCT00082433|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
1253317|NCT00082433|O2|Outcome|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
1253318|NCT00082433|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
1253319|NCT00082433|O2|Outcome|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
1253320|NCT00082433|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
1253321|NCT00082433|O2|Outcome|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
1253322|NCT00082433|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
1253323|NCT00082433|O2|Outcome|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
1253324|NCT00082433|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
1253325|NCT00082433|O2|Outcome|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
1253327|NCT00082433|O2|Outcome|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
1253328|NCT00082433|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
1253329|NCT00082433|E2|Reported Event|Ixabepilone + Capecitabine|
1253330|NCT00082433|E1|Reported Event|Capecitabine|
1253331|NCT00082407|B3|Baseline|Total|Total of all reporting groups
1253332|NCT00082407|B2|Baseline|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
1253333|NCT00082407|B1|Baseline|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
1253334|NCT00082407|P2|Participant Flow|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
1253335|NCT00082407|P1|Participant Flow|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
1253336|NCT00082407|O2|Outcome|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
1253338|NCT00082407|O2|Outcome|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
1253339|NCT00082407|O1|Outcome|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
1253340|NCT00082407|O2|Outcome|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
1253341|NCT00082407|O1|Outcome|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
1253342|NCT00082407|O2|Outcome|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
1253343|NCT00082407|O1|Outcome|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
1253344|NCT00082407|O2|Outcome|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
1253345|NCT00082407|O1|Outcome|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
1253346|NCT00082407|O2|Outcome|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
1253347|NCT00082407|O1|Outcome|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
1253348|NCT00082407|O2|Outcome|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
1253349|NCT00082407|O1|Outcome|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
1253350|NCT00082407|E2|Reported Event|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
1253351|NCT00082407|E1|Reported Event|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
1253352|NCT00082381|B3|Baseline|Total|Total of all reporting groups
1253353|NCT00082381|B2|Baseline|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
1253354|NCT00082381|B1|Baseline|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
1253355|NCT00082381|P2|Participant Flow|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
1253356|NCT00082381|P1|Participant Flow|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
1253357|NCT00082381|O2|Outcome|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
1253358|NCT00082381|O1|Outcome|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
1253359|NCT00082381|O2|Outcome|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
1253360|NCT00082381|O1|Outcome|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
1253361|NCT00082381|O2|Outcome|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
1253362|NCT00082381|O1|Outcome|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
1253363|NCT00082381|O2|Outcome|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
1253364|NCT00082381|O1|Outcome|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
1253365|NCT00082381|O2|Outcome|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
1253366|NCT00082381|O1|Outcome|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
1253367|NCT00082381|O2|Outcome|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
1253368|NCT00082381|O1|Outcome|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
1253369|NCT00082381|O2|Outcome|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
1253370|NCT00082381|O1|Outcome|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
1253371|NCT00082381|E2|Reported Event|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
1253372|NCT00082381|E1|Reported Event|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
1253373|NCT00082368|B1|Baseline|PET Imaging With Tc-94m Sestamibi|"PET sestamibi scans followed by tariquidar and repeat imaging~Tariquidar: 3 days after initial PET patients will receive tariquidar and repeat imaging.~Tc-94m Sestamibi: Patients over 18 years of age, who are eligible for, or have completed enrollment in an active NCI protocol for treatment of cancer will undergo a PET sestamibi scan"
1254348|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
1253374|NCT00082368|P1|Participant Flow|PET Imaging With Tc-94m Sestamibi|"PET sestamibi scans followed by tariquidar and repeat imaging~Tariquidar: 3 days after initial PET patients will receive tariquidar and repeat imaging.~Tc-94m Sestamibi: Patients over 18 years of age, who are eligible for, or have completed enrollment in an active NCI protocol for treatment of cancer will undergo a PET sestamibi scan"
1253375|NCT00082368|O1|Outcome|PET Imaging With Tc-94m Sestamibi|"PET sestamibi scans followed by tariquidar and repeat imaging~Tariquidar: 3 days after initial PET patients will receive tariquidar and repeat imaging.~Tc-94m Sestamibi: Patients over 18 years of age, who are eligible for, or have completed enrollment in an active NCI protocol for treatment of cancer will undergo a PET sestamibi scan"
1253376|NCT00082368|O1|Outcome|PET Imaging With Tc-94m Sestamibi|"PET sestamibi scans followed by tariquidar and repeat imaging~Tariquidar: 3 days after initial PET patients will receive tariquidar and repeat imaging.~Tc-94m Sestamibi: Patients over 18 years of age, who are eligible for, or have completed enrollment in an active NCI protocol for treatment of cancer will undergo a PET sestamibi scan"
1253453|NCT00081770|O3|Outcome|PEGASYS 180 ug/wk Plus COPEGUS|PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
1253377|NCT00082368|E1|Reported Event|PET Imaging With Tc-94m Sestamibi|"PET sestamibi scans followed by tariquidar and repeat imaging~Tariquidar: 3 days after initial PET patients will receive tariquidar and repeat imaging.~Tc-94m Sestamibi: Patients over 18 years of age, who are eligible for, or have completed enrollment in an active NCI protocol for treatment of cancer will undergo a PET sestamibi scan"
1253378|NCT00082355|B1|Baseline|Alteplase|Dose of Alteplase will not exceed 10 mg/d/leg and is delivered in a concentration of 100ug/mL. The actual dose delivered is based upon the length of the thrombosed vein and 1 mL is injected directly into each centimeter of a thrombosed vein in a lower extremity. The treatment will be repeated up to 4 times over a 5 day period.
1253379|NCT00082355|P1|Participant Flow|Alteplase|Dose of Alteplase will not exceed 10 mg/d/leg and is delivered in a concentration of 100ug/mL. The actual dose delivered is based upon the length of the thrombosed vein and 1 mL is injected directly into each centimeter of a thrombosed vein in a lower extremity. The treatment will be repeated up to 4 times over a 5 day period.
1253380|NCT00082355|O1|Outcome|Alteplase|Dose of Alteplase will not exceed 10 mg/d/leg and is delivered in a concentration of 100ug/mL. The actual dose delivered is based upon the length of the thrombosed vein and 1 mL is injected directly into each centimeter of a thrombosed vein in a lower extremity. The treatment will be repeated up to 4 times over a 5 day period.
1253381|NCT00082355|O1|Outcome|Alteplase|Dose of Alteplase will not exceed 10 mg/d/leg and is delivered in a concentration of 100ug/mL. The actual dose delivered is based upon the length of the thrombosed vein and 1 mL is injected directly into each centimeter of a thrombosed vein in a lower extremity. The treatment will be repeated up to 4 times over a 5 day period.
1253382|NCT00082355|E1|Reported Event|Alteplase|Dose of Alteplase will not exceed 10 mg/d/leg and is delivered in a concentration of 100ug/mL. The actual dose delivered is based upon the length of the thrombosed vein and 1 mL is injected directly into each centimeter of a thrombosed vein in a lower extremity. The treatment will be repeated up to 4 times over a 5 day period.
1253383|NCT00082342|B3|Baseline|Total|Total of all reporting groups
1253384|NCT00082342|B2|Baseline|Sham tDCS|Subjects received sham transcranial direct current stimulation
1253385|NCT00082342|B1|Baseline|Real tDCS|Subjects received real transcranial direct current stimulation
1253386|NCT00082342|P2|Participant Flow|Sham tDCS|"Subjects receiving sham transcranial direct current stimulation, had electrodes placed on the subjects head in a manner which caused a temporary tingling sensation without effects on the brain. Subjects receiving sham transcranial direct current stimulation underwent 8 sessions during a 2 1/2 week period while on medication."
1253387|NCT00082342|P1|Participant Flow|Real tDCS|"Transcranial direct current stimulation (tDCS) is a method of non-invasive brain stimulation whereby a direct current is applied to the brain via surface electrodes on the head for a specified time period. It is a form of neurostimulation. Subjects receiving real transcranial direct current stimulation underwent 8 sessions during a 2 1/2 week period while on medication. A battery driven stimulator, Phoresor II Model PM850 delivered the tDCS through electrodes."
1253388|NCT00082342|O4|Outcome|Sham tDCS While Off Medication|Bradykinesia measured in the hands and arms while off medication and receiving sham tDCS.
1253389|NCT00082342|O3|Outcome|Real tDCS While Off Medication|Bradykinesia measured in the hands and arms while off medication and receiving real tDCS.
1253390|NCT00082342|O2|Outcome|Sham tDCS While on Medication|Bradykinesia measured in the hands and arms while on medication and receiving sham tDCS.
1253391|NCT00082342|O1|Outcome|Real tDCS While on Medication|Bradykinesia measured in the hands and arms while on medication and receiving real tDCS.
1253392|NCT00082342|O4|Outcome|Sham tDCS While Off Medication|The motor UPDRS score off medication while receiving sham tDCS
1253393|NCT00082342|O3|Outcome|Real tDCS While Off Medication|The motor UPDRS score off medication while receiving real tDCS
1253394|NCT00082342|O2|Outcome|Sham tDCS While on Medication|The motor UPDRS score on medication while receiving sham tDCS
1253395|NCT00082342|O1|Outcome|Real tDCS While on Medication|The motor UPDRS score on medication while receiving real tDCS
1253396|NCT00082342|O4|Outcome|Sham tDCS While Off Medication|The total UPDRS score off medication while receiving sham tDCS
1253397|NCT00082342|O3|Outcome|Real tDCS While Off Medication|The total UPDRS score off medication while receiving real tDCS
1253398|NCT00082342|O2|Outcome|Sham tDCS While on Medication|The total UPDRS score on medication while receiving sham tDCS
1253399|NCT00082342|O1|Outcome|Real tDCS While on Medication|The total UPDRS score on medication while receiving real tDCS
1253400|NCT00082342|O4|Outcome|Sham tDCS While Off Medication|Timed gait during 10m walking task in subjects off medication at baseline, one day post sham tDCS, one month post sham tDCS, three month post sham tDCS.
1253401|NCT00082342|O3|Outcome|Real tDCS While Off Medication|Timed gait during 10m walking task in subjects off medication at baseline, one day post tDCS, one month post tDCS, three month post tDCS.
1253402|NCT00082342|O2|Outcome|Sham tDCS While on Medication|Timed gait during 10m walking task in subjects on medication at baseline, one day post sham tDCS, one month post sham tDCS, three month post sham tDCS.
1254349|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
1253403|NCT00082342|O1|Outcome|Real tDCS While on Medication|Timed gait during 10m walking task in subjects on medication at baseline, one day post tDCS, one month post tDCS, three month post tDCS.
1253404|NCT00082342|E2|Reported Event|Sham tDCS|Subjects received sham transcranial direct current stimulation
1253405|NCT00082342|E1|Reported Event|Real tDCS|Subjects received real transcranial direct current stimulation
1253406|NCT00082329|B1|Baseline|AMD 3100 (Mozobil Plerixafor)|"Healthy volunteers will be administered AMD 3100 (Mozobil plerixafor) and granulocyte colony stimulating factor (G-CSF) to determine cytokine polarization status of cluster of differentiation (CD 4) T-cells collected by apheresis~AMD 3100 (Mozobil plerixafor) : Healthy volunteers will be administered AMD 3100 (Mozobil plerixafor) and granulocyte colony stimulating factor (G-CSF) to determine cytokine polarization status of cluster of differentiation (CD 4) T-cells collected by apheresis"
1253407|NCT00082329|P1|Participant Flow|AMD 3100 (Mozobil Plerixafor)|Healthy volunteers will be administered AMD 3100 (Mozobil plerixafor) and granulocyte colony stimulating factor (G-CSF) to determine cytokine polarization status of cluster of differentiation (CD 4) T-cells collected by apheresis
1253486|NCT00081731|O1|Outcome|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
1253408|NCT00082329|O1|Outcome|AMD 3100 and G-CSF Responders|"Healthy volunteers will be administered AMD 3100 (Mozobil plerixafor) and granulocyte colony stimulating factor (G-CSF) to determine cytokine polarization status of cluster of differentiation (CD 4) T-cells collected by apheresis~We propose that the combination of single dose AMD 3100 and G-CSF as combined mobilizing agents will improve the peripheral blood progenitor cells mobilization as compared to G-CSF mobilization."
1253409|NCT00082329|E1|Reported Event|AMD 3100 & G-CSF Respnders|"Healthy volunteers will be administered AMD 3100 (Mozobil plerixafor) and granulocyte colony stimulating factor (G-CSF) to determine cytokine polarization status of cluster of differentiation (CD 4) T-cells collected by apheresis~We propose that the combination of single dose AMD 3100 and G-CSF as combined mobilizing agents will improve the peripheral blood progenitor cells mobilization as compared to G-CSF mobilization."
1253410|NCT00082173|B3|Baseline|Total|Total of all reporting groups
1253411|NCT00082173|B2|Baseline|Control Arm (EMB)|
1253412|NCT00082173|B1|Baseline|Experimental Arm (Moxi)|
1253413|NCT00082173|P2|Participant Flow|Control Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks
1253414|NCT00082173|P1|Participant Flow|Experimental Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks
1253415|NCT00082173|O2|Outcome|Control Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks
1253416|NCT00082173|O1|Outcome|Experimental Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks
1253417|NCT00082173|O2|Outcome|Control Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks
1253418|NCT00082173|O1|Outcome|Experimental Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks
1253419|NCT00082173|E2|Reported Event|Control Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks
1253420|NCT00082173|E1|Reported Event|Experimental Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks
1253421|NCT00082017|B1|Baseline|UCN-01 for T-cell Lymphomas - Cohort 1&2|"Cohort 1 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2~Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 28 days.~Cohort 2 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2~Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days."
1253422|NCT00082017|P2|Participant Flow|UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days|"Cohort 2 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2~Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days."
1253423|NCT00082017|P1|Participant Flow|UCN-01 for T-cell Lymphomas - Cohort 1-Every 28 Days|"Cohort 1 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2~Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2. Repeat cycles every 28 days."
1253424|NCT00082017|O2|Outcome|UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days.
1253425|NCT00082017|O1|Outcome|UCN-01 for T-cell Lymphomas - Cohort 1 Every 28 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2. Repeat cycles every 28 days.
1253426|NCT00082017|O2|Outcome|UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days.
1253427|NCT00082017|O1|Outcome|UCN-01 for T-cell Lymphomas - Cohort 1 Every 28 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2. Repeat cycles every 28 days.
1253428|NCT00082017|O2|Outcome|UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days.
1253429|NCT00082017|O1|Outcome|UCN-01 for T-cell Lymphomas - Cohort 1 Every 28 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2. Repeat cycles every 28 days.
1253445|NCT00081861|E1|Reported Event|Avastin + Rituximab|Avastin 10 mg/kg given intravenously every 2 weeks for 4 doses, and Rituximab 375 mg/m^2 intravenously weekly for 8 doses.
1253446|NCT00081770|B4|Baseline|Total|Total of all reporting groups
1254350|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
1253430|NCT00082017|O1|Outcome|UCN-01 for T-cell Lymphomas - Cohort 1&2|"Cohort 1 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2. Repeat cycles every 28 days.~Cohort 2 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days."
1253431|NCT00082017|O2|Outcome|UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days.
1253432|NCT00082017|O1|Outcome|UCN-01 for T-cell Lymphomas - Cohort 1 Every 28 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2. Repeat cycles every 28 days.
1253433|NCT00082017|O2|Outcome|UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days.
1253434|NCT00082017|O1|Outcome|UCN-01 for T-cell Lymphomas - Cohort 1 Every 28 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2. Repeat cycles every 28 days.
1253435|NCT00082017|O2|Outcome|UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days.
1253436|NCT00082017|O1|Outcome|UCN-01 for T-cell Lymphomas - Cohort 1 Every 28 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2. Repeat cycles every 28 days.
1253437|NCT00082017|E1|Reported Event|UCN-01 for T-cell Lymphomas - Cohort 1&2|"Cohort 1 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2~Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 28 days.~Cohort 2 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2~Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days."
1253438|NCT00081939|B1|Baseline|Study Treatment|Two cycles of VDTPACE induction (Velcade days 1, 4, 8, and 11; DTPACE days 4-7) with interim thalidomide (50 mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle. Induction followed by single or tandem MEL200 transplant (MEL140 mg/m2 for subjects > 70 years of age) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each transplant. Transplants followed by two cycles of VDTPACE consolidation (Velcade days 1, 4, 8, and 11; DTPACE days 1-4) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle of VDTPACE. Consolidation followed by 3 years of maintenance therapy with VDT (velcade 1.0 mg/m2 days 1, 4, 8, 11 q 28 days; Thal 100 mg QD; and Dex 20mg days 1-4 and 8-11 q 28 days) during Year 1 and TD (Thal 100 mg QD and Dex 20 mg days 1-4, q 28 days) or VTD (velcade 1.0 mg/m2 weekly, Thal 100 mg QD, and Dex 20 mg weekly) during Years 2 and 3.
1253439|NCT00081939|P1|Participant Flow|Study Treatment|Two cycles of VDTPACE induction (Velcade days 1, 4, 8, and 11; DTPACE days 4-7) with interim thalidomide (50 mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle. Induction followed by single or tandem MEL200 transplant (MEL140 mg/m2 for subjects > 70 years of age) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each transplant. Transplants followed by two cycles of VDTPACE consolidation (Velcade days 1, 4, 8, and 11; DTPACE days 1-4) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle of VDTPACE. Consolidation followed by 3 years of maintenance therapy with VDT (velcade 1.0 mg/m2 days 1, 4, 8, 11 q 28 days; Thal 100 mg QD; and Dex 20mg days 1-4 and 8-11 q 28 days) during Year 1 and TD (Thal 100 mg QD and Dex 20 mg days 1-4, q 28 days) or VTD (velcade 1.0 mg/m2 weekly, Thal 100 mg QD, and Dex 20 mg weekly) during Years 2 and 3.
1253440|NCT00081939|O1|Outcome|Study Treatment|Two cycles of VDTPACE induction (Velcade days 1, 4, 8, and 11; DTPACE days 4-7) with interim thalidomide (50 mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle. Induction followed by single or tandem MEL200 transplant (MEL140 mg/m2 for subjects > 70 years of age) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each transplant. Transplants followed by two cycles of VDTPACE consolidation (Velcade days 1, 4, 8, and 11; DTPACE days 1-4) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle of VDTPACE. Consolidation followed by 3 years of maintenance therapy with VDT (velcade 1.0 mg/m2 days 1, 4, 8, 11 q 28 days; Thal 100 mg QD; and Dex 20mg days 1-4 and 8-11 q 28 days) during Year 1 and TD (Thal 100 mg QD and Dex 20 mg days 1-4, q 28 days) or VTD (velcade 1.0 mg/m2 weekly, Thal 100 mg QD, and Dex 20 mg weekly) during Years 2 and 3.
1253441|NCT00081939|E1|Reported Event|Study Treatment|Two cycles of VDTPACE induction (Velcade days 1, 4, 8, and 11; DTPACE days 4-7) with interim thalidomide (50 mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle. Induction followed by single or tandem MEL200 transplant (MEL140 mg/m2 for subjects > 70 years of age) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each transplant. Transplants followed by two cycles of VDTPACE consolidation (Velcade days 1, 4, 8, and 11; DTPACE days 1-4) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle of VDTPACE. Consolidation followed by 3 years of maintenance therapy with VDT (velcade 1.0 mg/m2 days 1, 4, 8, 11 q 28 days; Thal 100 mg QD; and Dex 20mg days 1-4 and 8-11 q 28 days) during Year 1 and TD (Thal 100 mg QD and Dex 20 mg days 1-4, q 28 days) or VTD (velcade 1.0 mg/m2 weekly, Thal 100 mg QD, and Dex 20 mg weekly) during Years 2 and 3.
1253442|NCT00081861|B1|Baseline|Avastin + Rituximab|Avastin 10 mg/kg given intravenously every 2 weeks for 4 doses, and Rituximab 375 mg/m^2 intravenously weekly for 8 doses.
1253443|NCT00081861|P1|Participant Flow|Avastin + Rituximab|Avastin 10 mg/kg given intravenously every 2 weeks for 4 doses, and Rituximab 375 mg/m^2 intravenously weekly for 8 doses.
1253444|NCT00081861|O1|Outcome|Avastin + Rituximab|Avastin 10 mg/kg given intravenously every 2 weeks for 4 doses, and Rituximab 375 mg/m^2 intravenously weekly for 8 doses.
1253447|NCT00081770|B3|Baseline|PEGASYS 180 ug/wk Plus COPEGUS|PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
1253448|NCT00081770|B2|Baseline|PegIntron 1.0 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
1253449|NCT00081770|B1|Baseline|PegIntron 1.5 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
1253450|NCT00081770|P3|Participant Flow|PEGASYS 180 ug/wk Plus COPEGUS|PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
1253451|NCT00081770|P2|Participant Flow|PegIntron 1.0 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
1253452|NCT00081770|P1|Participant Flow|PegIntron 1.5 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
1253672|NCT00080301|E2|Reported Event|Ixabepilone + Capecitabine|
1253454|NCT00081770|O2|Outcome|PegIntron 1.0 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
1253455|NCT00081770|O1|Outcome|PegIntron 1.5 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
1253456|NCT00081770|O3|Outcome|PEGASYS 180 ug/wk Plus COPEGUS|PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
1253457|NCT00081770|O2|Outcome|PegIntron 1.0 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
1253458|NCT00081770|O1|Outcome|PegIntron 1.5 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
1253459|NCT00081770|O3|Outcome|PEGASYS 180 ug/wk Plus COPEGUS|PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
1253460|NCT00081770|O2|Outcome|PegIntron 1.0 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
1253461|NCT00081770|O1|Outcome|PegIntron 1.5 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
1253462|NCT00081770|O3|Outcome|PEGASYS 180 ug/wk Plus COPEGUS|PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
1253463|NCT00081770|O2|Outcome|PegIntron 1.0 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
1253464|NCT00081770|O1|Outcome|PegIntron 1.5 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
1253465|NCT00081770|E3|Reported Event|PEGASYS 180 ug/wk Plus COPEGUS|
1253466|NCT00081770|E2|Reported Event|PegIntron 1.0 ug/kg/wk Plus REBETOL|
1253467|NCT00081770|E1|Reported Event|PegIntron 1.5 ug/kg/wk Plus REBETOL|
1253468|NCT00081731|B3|Baseline|Total|Total of all reporting groups
1253469|NCT00081731|B2|Baseline|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
1253470|NCT00081731|B1|Baseline|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
1253471|NCT00081731|P2|Participant Flow|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
1253472|NCT00081731|P1|Participant Flow|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
1253473|NCT00081731|O2|Outcome|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
1253474|NCT00081731|O1|Outcome|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
1253475|NCT00081731|O2|Outcome|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
1253476|NCT00081731|O1|Outcome|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
1253477|NCT00081731|O2|Outcome|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
1253478|NCT00081731|O1|Outcome|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
1253554|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
1253479|NCT00081731|O2|Outcome|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
1253480|NCT00081731|O1|Outcome|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
1253481|NCT00081731|O2|Outcome|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
1253482|NCT00081731|O1|Outcome|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
1253483|NCT00081731|O2|Outcome|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
1253484|NCT00081731|O1|Outcome|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
1253485|NCT00081731|O2|Outcome|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
1253673|NCT00080301|E1|Reported Event|Capecitabine|
1253487|NCT00081731|E2|Reported Event|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
1253488|NCT00081731|E1|Reported Event|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
1253489|NCT00081653|B3|Baseline|Total|Total of all reporting groups
1253490|NCT00081653|B2|Baseline|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
1253491|NCT00081653|B1|Baseline|Ibandronate 100 mg|100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
1253492|NCT00081653|P2|Participant Flow|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
1253493|NCT00081653|P1|Participant Flow|Ibandronate 100 Milligrams (mg)|100 mg ibandronate oral (PO) monthly and monthly oral placebo (corresponding to the 150 mg tablet)
1253494|NCT00081653|O2|Outcome|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
1253495|NCT00081653|O1|Outcome|Ibandronate 100 mg|100 mg ibandgronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
1253496|NCT00081653|O2|Outcome|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
1253497|NCT00081653|O1|Outcome|Ibandronate 100 mg|100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
1253498|NCT00081653|O2|Outcome|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
1253499|NCT00081653|O1|Outcome|Ibandronate 100 mg|100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
1253500|NCT00081653|O2|Outcome|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
1253501|NCT00081653|O1|Outcome|Ibandronate 100 mg|100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
1253502|NCT00081653|O2|Outcome|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
1253503|NCT00081653|O1|Outcome|Ibandronate 100 mg|100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
1253504|NCT00081653|O2|Outcome|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
1253505|NCT00081653|O1|Outcome|Ibandronate 100 mg|100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
1253506|NCT00081653|E2|Reported Event|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
1253507|NCT00081653|E1|Reported Event|Ibandronate 100 mg|100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
1253508|NCT00081497|B3|Baseline|Total|Total of all reporting groups
1253509|NCT00081497|B2|Baseline|Fabrazyme/Fabrazyme|Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry into AGAL02503 (NCT00081497).
1253510|NCT00081497|B1|Baseline|Placebo/Fabrazyme|Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry to AGAL02503 (NCT00081497).
1253511|NCT00081497|P2|Participant Flow|Fabrazyme/Fabrazyme|Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry into AGAL02503 (NCT00081497).
1253512|NCT00081497|P1|Participant Flow|Placebo/Fabrazyme|Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry to AGAL02503 (NCT00081497).
1253513|NCT00081497|O1|Outcome|Fabrazyme 1.0 mg/kg Every 2 Weeks|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks for 18 months. This is an open-label extension study to AGAL-008-00 (NCT00074984) and all patients received Fabrazyme treatment.
1253514|NCT00081497|O1|Outcome|Fabrazyme 1.0 mg/kg Every 2 Weeks|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks for 18 months. This is an open-label extension study to AGAL-008-00 (NCT00074984) and all patients received Fabrazyme treatment.
1253515|NCT00081497|O1|Outcome|Fabrazyme 1.0 mg/kg Every 2 Weeks|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks for 18 months. This is an open-label extension study to AGAL-008-00 (NCT00074984) and all patients received Fabrazyme treatment.
1253516|NCT00081497|O1|Outcome|Fabrazyme 1.0 mg/kg Every 2 Weeks|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks for 18 months. This is an open-label extension study to AGAL-008-00 (NCT00074984) and all patients received Fabrazyme treatment.
1253517|NCT00081497|O4|Outcome|Fabrazyme - AGAL02503 (NCT00081497) eGFR ≤60|Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme prior to or at entry into AGAL02503 (NCT00081497) using all Fabrazyme treatment period data from the AGAL00800 (NCT00074984) and AGAL02503 (NCT00081497) studies.
1253518|NCT00081497|O3|Outcome|Placebo - AGAL-008-00 (NCT00074984) eGFR ≤60|Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme prior to or at entry to AGAL02503 (NCT00081497) using only placebo period data from the AGAL-008-00 (NCT00074984) study.
1253519|NCT00081497|O2|Outcome|Fabrazyme - AGAL02503 (NCT00081497) eGFR >60|Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme prior to or at entry into AGAL02503 (NCT00081497) using all Fabrazyme treatment period data from the AGAL00800 (NCT00074984) and AGAL02503 (NCT00081497) studies.
1253520|NCT00081497|O1|Outcome|Placebo - AGAL-008-00 (NCT00074984) eGFR >60|Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) using only placebo period data from the AGAL-008-00 (NCT00074984) study.
1253521|NCT00081497|O2|Outcome|Fabrazyme Period - AGAL02503 (NCT00081497)|Placebo patients who had been transitioned to open-label Fabrazyme prior to or at entry into AGAL02503 (NCT00081497). 1.0 mg/kg of Fabrazyme given to the patients every 2 weeks for 18 months.
1253522|NCT00081497|O1|Outcome|Placebo Period - AGAL-008-00 (NCT00074984)|Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984).
1253523|NCT00081497|E3|Reported Event|Total|
1253524|NCT00081497|E2|Reported Event|Placebo/Fabrazyme|Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry to AGAL02503 (NCT00081497).
1253525|NCT00081497|E1|Reported Event|Fabrazyme/Fabrazyme|Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry into AGAL02503 (NCT00081497).
1253526|NCT00081458|B4|Baseline|Total|Total of all reporting groups
1253527|NCT00081458|B3|Baseline|Teduglutide 0.1 mg/kg/d|teduglutide 0.1 mg/kg/d injected subcutaneously
1253528|NCT00081458|B2|Baseline|Teduglutide 0.05 mg/kg/d|teduglutide 0.05 mg/kg/d injected subcutaneously
1253529|NCT00081458|B1|Baseline|Placebo|Placebo injected subcutaneously daily
1253530|NCT00081458|P3|Participant Flow|Teduglutide 0.1 mg/kg/d|teduglutide 0.1 mg/kg/d injected subcutaneously
1253531|NCT00081458|P2|Participant Flow|Teduglutide 0.05 mg/kg/d|teduglutide 0.05 mg/kg/d injected subcutaneously
1253532|NCT00081458|P1|Participant Flow|Placebo|Placebo injected subcutaneously daily
1253533|NCT00081458|O3|Outcome|Teduglutide 0.1 mg/kg/d|teduglutide 0.1 mg/kg/d injected subcutaneously
1253534|NCT00081458|O2|Outcome|Teduglutide 0.05 mg/kg/d|teduglutide 0.05 mg/kg/d injected subcutaneously
1253535|NCT00081458|O1|Outcome|Placebo|Placebo injected subcutaneously daily into the thigh or abdomen
1253536|NCT00081458|O3|Outcome|Teduglutide 0.1 mg/kg/d|teduglutide 0.1 mg/kg/d injected subcutaneously
1253537|NCT00081458|O2|Outcome|Teduglutide 0.05 mg/kg/d|teduglutide 0.05 mg/kg/d injected subcutaneously
1253538|NCT00081458|O1|Outcome|Placebo|Placebo injectable subcutaneously daily into the thigh or abdomen
1253539|NCT00081458|E3|Reported Event|Teduglutide 0.1 mg/kg/d|teduglutide 0.1 mg/kg/d injected subcutaneously
1253540|NCT00081458|E2|Reported Event|Teduglutide 0.05 mg/kg/d|teduglutide 0.05 mg/kg/d injected subcutaneously
1253541|NCT00081458|E1|Reported Event|Placebo|Placebo injected subcutaneously daily
1253542|NCT00081328|B4|Baseline|Total|Total of all reporting groups
1253543|NCT00081328|B3|Baseline|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
1253544|NCT00081328|B2|Baseline|2 Metformin + Rosiglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
1253545|NCT00081328|B1|Baseline|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
1253546|NCT00081328|P3|Participant Flow|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid, encapsulated, provided in weekly packets~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
1253547|NCT00081328|P2|Participant Flow|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid, provided encapsulated in weekly packets"
1253548|NCT00081328|P1|Participant Flow|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid, provided encapsulated in weekly packets"
1253549|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
1253550|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
1253551|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
1253552|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
1253553|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
1253555|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
1253556|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
1253557|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
1253558|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
1253559|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
1253560|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
1253674|NCT00080288|B3|Baseline|Total|Total of all reporting groups
1253561|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
1253562|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
1253563|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
1253564|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
1253565|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
1253566|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
1253567|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
1253568|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
1253569|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
1253570|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
1253571|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
1253572|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
1253573|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
1253574|NCT00081328|O2|Outcome|2 Metformin + Rosiglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
1253575|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
1253576|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
1253577|NCT00081328|O2|Outcome|2 Metformin + Rosiglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
1253578|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
1253579|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
1253580|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
1253581|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
1253623|NCT00080899|B1|Baseline|Arm 1|Patients received Fenretinide (N-(4-hydroxyphenyl) retinamide [4-HPR]) at a dose of 900 mg/m2 twice daily for the maximal practical dose of 1800 mg/m2/day for 1 week, every 3 weeks, for 1 year.
1254351|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
1253582|NCT00081328|E3|Reported Event|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
1253583|NCT00081328|E2|Reported Event|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
1253584|NCT00081328|E1|Reported Event|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
1253585|NCT00081289|B3|Baseline|Total|Total of all reporting groups
1253586|NCT00081289|B2|Baseline|Neoadjuvant Chemoradiation With Oxaliplatin|Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
1253587|NCT00081289|B1|Baseline|Neoadjuvant Chemoradiation With Irinotecan|Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
1253588|NCT00081289|P2|Participant Flow|Neoadjuvant Chemoradiation With Oxaliplatin|Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
1253675|NCT00080288|B2|Baseline|Placebo|Matching placebo tablets once daily
1253589|NCT00081289|P1|Participant Flow|Neoadjuvant Chemoradiation With Irinotecan|Patients receive neoadjuvant therapy comprising radiotherapy (RT), 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
1253590|NCT00081289|O2|Outcome|Neoadjuvant Chemoradiation With Oxaliplatin|Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
1253591|NCT00081289|O1|Outcome|Neoadjuvant Chemoradiation With Irinotecan|Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
1253592|NCT00081289|E2|Reported Event|Neoadjuvant Chemoradiation With Oxaliplatin|Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
1253593|NCT00081289|E1|Reported Event|Neoadjuvant Chemoradiation With Irinotecan|Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
1253594|NCT00081159|B3|Baseline|Total|Total of all reporting groups
1253595|NCT00081159|B2|Baseline|HAT, Doxorubicin + Zoledronate|Arm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses.
1253596|NCT00081159|B1|Baseline|HAT, Doxorubicin, Zoledronate + Strontium Chloride|Arm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1.
1253597|NCT00081159|P2|Participant Flow|HAT, Doxorubicin + Zoledronate|Arm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses.
1253598|NCT00081159|P1|Participant Flow|HAT, Doxorubicin, Zoledronate + Strontium Chloride|Arm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin intravenous (IV) on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1.
1253599|NCT00081159|O2|Outcome|HAT, Doxorubicin + Zoledronate|Arm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses.
1253600|NCT00081159|O1|Outcome|HAT, Doxorubicin, Zoledronate + Strontium Chloride|Arm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1.
1253601|NCT00081159|O2|Outcome|HAT, Doxorubicin + Zoledronate|Arm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses.
1253602|NCT00081159|O1|Outcome|HAT, Doxorubicin, Zoledronate + Strontium Chloride|Arm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1.
1253624|NCT00080899|P1|Participant Flow|Arm 1|Patients received Fenretinide (N-(4-hydroxyphenyl) retinamide [4-HPR]) at a dose of 900 mg/m2 twice daily for the maximal practical dose of 1800 mg/m2/day for 1 week, every 3 weeks, for 1 year.
1254352|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
1253603|NCT00081159|O2|Outcome|HAT, Doxorubicin + Zoledronate|Arm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses.
1253604|NCT00081159|O1|Outcome|HAT, Doxorubicin, Zoledronate + Strontium Chloride|Arm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1.
1253605|NCT00081159|E2|Reported Event|HAT, Doxorubicin + Zoledronate|Arm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses.
1253606|NCT00081159|E1|Reported Event|HAT, Doxorubicin, Zoledronate + Strontium Chloride|Arm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1.
1253607|NCT00080938|B1|Baseline|Temozolamide and Radiation|Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).
1253608|NCT00080938|P1|Participant Flow|Temozolamide and Radiation|Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).
1253609|NCT00080938|O1|Outcome|Temozolamide and Radiation|Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).
1253610|NCT00080938|O1|Outcome|Temozolamide and Radiation|Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).
1253611|NCT00080938|O1|Outcome|Temozolamide and Radiation|Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).
1253612|NCT00080938|O1|Outcome|Temozolamide and Radiation|Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).
1253613|NCT00080938|E1|Reported Event|Temozolamide and Radiation|Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).
1253614|NCT00080912|B3|Baseline|Total|Total of all reporting groups
1253615|NCT00080912|B2|Baseline|Multiple-fraction|"Patients receive multiple-fraction radiotherapy (to a total of 20 Gy) over 5 days or over 8 days if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions.~radiation therapy: Given in a single fraction or multiple fractions"
1253616|NCT00080912|B1|Baseline|Single-fraction|"Patients receive single-fraction radiotherapy (8 Gy) on day 1.~radiation therapy: Given in a single fraction or multiple fractions"
1253617|NCT00080912|P2|Participant Flow|Multiple-fraction|"Patients receive multiple-fraction radiotherapy (to a total of 20 Gy) over 5 days or over 8 days if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions.~radiation therapy: Given in a single fraction or multiple fractions"
1253618|NCT00080912|P1|Participant Flow|Single-fraction|"Patients receive single-fraction radiotherapy (8 Gy) on day 1.~radiation therapy: Given in a single fraction or multiple fractions"
1253619|NCT00080912|O2|Outcome|Multiple-fraction|"Patients receive multiple-fraction radiotherapy (to a total of 20 Gy) over 5 days or over 8 days if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions.~radiation therapy: Given in a single fraction or multiple fractions"
1253620|NCT00080912|O1|Outcome|Single-fraction|"Patients receive single-fraction radiotherapy (8 Gy) on day 1.~radiation therapy: Given in a single fraction or multiple fractions"
1253621|NCT00080912|E2|Reported Event|Multiple-fraction|"Patients receive multiple-fraction radiotherapy (to a total of 20 Gy) over 5 days or over 8 days if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions.~radiation therapy: Given in a single fraction or multiple fractions"
1253622|NCT00080912|E1|Reported Event|Single-fraction|"Patients receive single-fraction radiotherapy (8 Gy) on day 1.~radiation therapy: Given in a single fraction or multiple fractions"
1253693|NCT00080119|B5|Baseline|Total|Total of all reporting groups
1253625|NCT00080899|O1|Outcome|Arm 1|Patients received Fenretinide (N-(4-hydroxyphenyl) retinamide [4-HPR]) at a dose of 900 mg/m2 twice daily for the maximal practical dose of 1800 mg/m2/day for 1 week, every 3 weeks, for 1 year.
1253626|NCT00080899|O1|Outcome|Arm 1|Patients received Fenretinide (N-(4-hydroxyphenyl) retinamide [4-HPR]) at a dose of 900 mg/m2 twice daily for the maximal practical dose of 1800 mg/m2/day for 1 week, every 3 weeks, for 1 year.
1253627|NCT00080899|E1|Reported Event|Arm 1|Patients received Fenretinide (N-(4-hydroxyphenyl) retinamide [4-HPR]) at a dose of 900 mg/m2 twice daily for the maximal practical dose of 1800 mg/m2/day for 1 week, every 3 weeks, for 1 year.
1253628|NCT00080535|B1|Baseline|LMB-2 for Cutaneous Tcell Lymphoma|30 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with cutaneous T-cell lymphoma, a group of lymphoproliferative disorders characterized by malignant CD4+ T-lymphocytes which localize tot he skin on initial presentation.
1253629|NCT00080535|P1|Participant Flow|LMB-2 for Cutaneous Tcell Lymphoma|30 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with cutaneous T-cell lymphoma, a group of lymphoproliferative disorders characterized by malignant CD4+ T-lymphocytes which localize tot he skin on initial presentation.
1253630|NCT00080535|O1|Outcome|LMB-2 for Cutaneous Tcell Lymphoma|30 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with cutaneous T-cell lymphoma, a group of lymphoproliferative disorders characterized by malignant CD4+ T-lymphocytes which localize tot he skin on initial presentation.
1253676|NCT00080288|B1|Baseline|Armodafinil 150 mg/Day|Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked
1253631|NCT00080535|O1|Outcome|LMB-2 for Cutaneous Tcell Lymphoma|30 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with cutaneous T-cell lymphoma, a group of lymphoproliferative disorders characterized by malignant CD4+ T-lymphocytes which localize tot he skin on initial presentation.
1253632|NCT00080535|E1|Reported Event|LMB-2 for Cutaneous Tcell Lymphoma|30 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with cutaneous T-cell lymphoma, a group of lymphoproliferative disorders characterized by malignant CD4+ T-lymphocytes which localize tot he skin on initial presentation.
1253633|NCT00080483|B3|Baseline|Total|Total of all reporting groups
1253634|NCT00080483|B2|Baseline|2Testosterone Plus Growth Hormone|AndroGel transdermally 5 g a day somatropin subcutaneously 2 µg/kg body weight a day
1253635|NCT00080483|B1|Baseline|1Testosterone Only|Testosterone transdermally 5 g a day
1253636|NCT00080483|P2|Participant Flow|2Testosterone Plus Growth Hormone|AndroGel transdermally 5 g a day somatropin subcutaneously 2 µg/kg body weight a day
1253637|NCT00080483|P1|Participant Flow|1Testosterone Only|Testosterone transdermally 5 g a day
1253638|NCT00080483|O2|Outcome|2 The Effects of Testosterone Alone on Structural and Mechanic|"AndroGel transdermally 5 g a day for two years~testosterone: AndroGel transdermally 5 g a day for two years"
1253639|NCT00080483|O1|Outcome|1 The Effects of Testosterone Combined With G|"AndroGel transdermally 5 g a day and somatropin subcutaneously 2 µg/kg body weight a day~AndroGel plus somatropin: AndoGel 5 grams transdermally a day for two years Somatropin 2 µg/kg body weight/day for two years"
1253640|NCT00080483|E2|Reported Event|2Testosterone Plus Growth Hormone|AndroGel transdermally 5 g a day somatropin subcutaneously 2 µg/kg body weight a day
1253641|NCT00080483|E1|Reported Event|1Testosterone Only|Testosterone transdermally 5 g a day
1253642|NCT00080470|B3|Baseline|Total|Total of all reporting groups
1253643|NCT00080470|B2|Baseline|Treatment|Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
1253644|NCT00080470|B1|Baseline|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
1253645|NCT00080470|P2|Participant Flow|Control|No Stimulation from post-implant until 45 days post-implant. Stimulation On from 45 days post-implant and on.
1253646|NCT00080470|P1|Participant Flow|Treatment|"Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit.~Stimulation On from 45 days post 12 month visit and on."
1253647|NCT00080470|O2|Outcome|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
1253648|NCT00080470|O1|Outcome|Treatment|Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
1253649|NCT00080470|O2|Outcome|Control|No Stimulation from post-implant until 45 days post-implant. Stimulation On from 45 days post-implant and on.
1253650|NCT00080470|O1|Outcome|Treatment|"Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit.~Stimulation On from 45 days post 12 month visit and on."
1253651|NCT00080470|E2|Reported Event|Treatment|Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
1253652|NCT00080470|E1|Reported Event|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
1253653|NCT00080301|B3|Baseline|Total|Total of all reporting groups
1253654|NCT00080301|B2|Baseline|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
1253655|NCT00080301|B1|Baseline|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
1253656|NCT00080301|P2|Participant Flow|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
1253657|NCT00080301|P1|Participant Flow|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
1253658|NCT00080301|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
1253659|NCT00080301|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
1253660|NCT00080301|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
1254353|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
1253661|NCT00080301|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
1253662|NCT00080301|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
1253663|NCT00080301|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
1253664|NCT00080301|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
1253665|NCT00080301|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
1253666|NCT00080301|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
1253667|NCT00080301|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
1253668|NCT00080301|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
1253669|NCT00080301|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
1253670|NCT00080301|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
1253671|NCT00080301|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
1253678|NCT00080288|P1|Participant Flow|Armodafinil 150 mg/Day|Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked
1253679|NCT00080288|O2|Outcome|Placebo|Matching placebo tablets once daily
1253680|NCT00080288|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked
1253681|NCT00080288|O2|Outcome|Placebo|Matching placebo tablets once daily
1253682|NCT00080288|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked
1253683|NCT00080288|E2|Reported Event|Placebo|Matching placebo tablets once daily
1253684|NCT00080288|E1|Reported Event|Armodafinil 150 mg/Day|Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked
1253685|NCT00080223|B1|Baseline|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose >4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
1253686|NCT00080223|P1|Participant Flow|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 milligram per day (mg/d). At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose greater than (>) 4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
1253687|NCT00080223|O1|Outcome|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose >4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
1253688|NCT00080223|O1|Outcome|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose >4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
1253689|NCT00080223|O1|Outcome|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose >4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
1253690|NCT00080223|O1|Outcome|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose >4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
1253691|NCT00080223|O1|Outcome|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose >4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
1253692|NCT00080223|E1|Reported Event|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose >4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
1253694|NCT00080119|B4|Baseline|HIVpos/PL|HIV-infected (HIVpos) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
1253695|NCT00080119|B3|Baseline|HIVpos/INH|HIV-infected (HIVpos) children receiving Isoniazid (INH) 10-20 mg/kg orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
1253696|NCT00080119|B2|Baseline|HIVneg/PL|Perinatally-exposed, HIV-uninfected (HIVneg) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding
1253697|NCT00080119|B1|Baseline|HIVneg/INH|Perinatally exposed, HIV-uninfected (HIVneg) children receiving Isoniazid (INH)10-20 mg/kg orally once a day for 96 weeks + Trimethoprim/Sulfamethoxazole (TMP/SMX) 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding
1253698|NCT00080119|P4|Participant Flow|HIVpos/PL|HIV-infected (HIVpos) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
1253699|NCT00080119|P3|Participant Flow|HIVpos/INH|HIV-infected (HIVpos) children receiving Isoniazid (INH) 10-20 mg/kg orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
1253700|NCT00080119|P2|Participant Flow|HIVneg/PL|Perinatally-exposed, HIV-uninfected (HIVneg) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding
1253701|NCT00080119|P1|Participant Flow|HIVneg/INH|Perinatally exposed, HIV-uninfected (HIVneg) children receiving Isoniazid (INH)10-20 mg/kg orally once a day for 96 weeks + Trimethoprim/Sulfamethoxazole (TMP/SMX) 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding
1253702|NCT00080119|O4|Outcome|HIVpos/PL|
1253703|NCT00080119|O3|Outcome|HIVpos/INH|
1253704|NCT00080119|O2|Outcome|HIVneg/PL|
1253705|NCT00080119|O1|Outcome|HIVneg/INH|
1253706|NCT00080119|O4|Outcome|HIVpos/PL|
1253707|NCT00080119|O3|Outcome|HIVpos/INH|
1253708|NCT00080119|O2|Outcome|HIVneg/PL|
1253709|NCT00080119|O1|Outcome|HIVneg/INH|
1253710|NCT00080119|O4|Outcome|HIVpos/PL|
1253711|NCT00080119|O3|Outcome|HIVpos/INH|
1253712|NCT00080119|O2|Outcome|HIVneg/PL|
1253713|NCT00080119|O1|Outcome|HIVneg/INH|
1253714|NCT00080119|O4|Outcome|HIVpos/PL|
1253715|NCT00080119|O3|Outcome|HIVpos/INH|
1253716|NCT00080119|O2|Outcome|HIVneg/PL|
1253717|NCT00080119|O1|Outcome|HIVneg/INH|
1253718|NCT00080119|O2|Outcome|HIVneg/PL|
1253719|NCT00080119|O1|Outcome|HIVneg/INH|
1253720|NCT00080119|O2|Outcome|HIVpos/PL|
1253721|NCT00080119|O1|Outcome|HIVpos/INH|
1253722|NCT00080119|O2|Outcome|HIVpos/PL|
1253723|NCT00080119|O1|Outcome|HIVpos/INH|
1253724|NCT00080119|O2|Outcome|HIVneg/PL|
1253725|NCT00080119|O1|Outcome|HIVneg/INH|
1253726|NCT00080119|O2|Outcome|HIVpos/PL|
1253727|NCT00080119|O1|Outcome|HIVpos/INH|
1253728|NCT00080119|E4|Reported Event|HIVpos/PL|HIV-infected (HIVpos) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
1253729|NCT00080119|E3|Reported Event|HIVpos/INH|HIV-infected (HIVpos) children receiving Isoniazid (INH) 10-20 mg/kg orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
1253730|NCT00080119|E2|Reported Event|HIVneg/PL|Perinatally-exposed, HIV-uninfected (HIVneg) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding
1253731|NCT00080119|E1|Reported Event|HIVneg/INH|Perinatally exposed, HIV-uninfected (HIVneg) children receiving Isoniazid (INH)10-20 mg/kg orally once a day for 96 weeks + Trimethoprim/Sulfamethoxazole (TMP/SMX) 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding
1253732|NCT00079937|B3|Baseline|Total|Total of all reporting groups
1253733|NCT00079937|B2|Baseline|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
1253734|NCT00079937|B1|Baseline|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
1253735|NCT00079937|P2|Participant Flow|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
1253875|NCT00079001|E1|Reported Event|Zoledronic Acid + Androgen Deprivation Therapy|4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
1253736|NCT00079937|P1|Participant Flow|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
1253737|NCT00079937|O2|Outcome|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
1253738|NCT00079937|O1|Outcome|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
1253739|NCT00079937|O2|Outcome|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
1254036|NCT00078377|O4|Outcome|Armodafinil Combined Group (250 mg/Day and 150 mg/Day)|
1254037|NCT00078377|O3|Outcome|Placebo|Matching placebo tablets once daily in the morning
1253740|NCT00079937|O1|Outcome|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
1253741|NCT00079937|O2|Outcome|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
1253742|NCT00079937|O1|Outcome|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
1253743|NCT00079937|O2|Outcome|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
1253744|NCT00079937|O1|Outcome|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
1253745|NCT00079937|O2|Outcome|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
1253746|NCT00079937|O1|Outcome|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
1253747|NCT00079937|O2|Outcome|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
1253748|NCT00079937|O1|Outcome|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
1253749|NCT00079937|E2|Reported Event|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
1253750|NCT00079937|E1|Reported Event|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
1253751|NCT00079781|B4|Baseline|Total|Total of all reporting groups
1253752|NCT00079781|B3|Baseline|Sham Group|Group of subjects who underwent RNS® System implantation who were randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the blinded Evaluation Period. Stimulation may have been enabled after transition into the Follow-Up Period (5th month post-implant) and may have continued for the remainder of the subject's participation in the study.
1253753|NCT00079781|B2|Baseline|Treatment Group|Group of subjects who underwent RNS® System implantation who were randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the blinded Evaluation Period. Stimulation was enabled during the first month post-implant and may have continued throughout the subject's participation in the study.
1253754|NCT00079781|B1|Baseline|Open Label Group|Group of subjects who underwent RNS® System implantation who were not randomized or blinded to therapy status during the Evaluation Period. Stimulation may have been enabled during the first month post-implant and may have continued throughout the subject's participation in the study.
1253755|NCT00079781|P3|Participant Flow|Sham Group|Group of subjects who underwent RNS® System implantation who were randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the blinded Evaluation Period. Stimulation may have been enabled after transition into the Follow-Up Period (5th month post-implant) and may have continued for the remainder of the subject's participation in the study.
1253756|NCT00079781|P2|Participant Flow|Treatment Group|Group of subjects who underwent RNS® System implantation who were randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the blinded Evaluation Period. Stimulation was enabled during the first month post-implant and may have continued throughout the subject's participation in the study.
1253757|NCT00079781|P1|Participant Flow|Open Label Group|Group of subjects who underwent RNS® System implantation who were not randomized or blinded to therapy status during the Evaluation Period. Stimulation may have been enabled during the first month post-implant and may have continued throughout the subject's participation in the study.
1253758|NCT00079781|O1|Outcome|Treatment Population|Open Label Group and Treatment Group combined.
1253759|NCT00079781|O1|Outcome|All Participants|Open Label Group, Treatment Group, and Sham Group combined.
1253760|NCT00079781|O1|Outcome|All Participants|Open Label Group, Treatment Group, and Sham Group combined.
1253761|NCT00079781|E2|Reported Event|Sham Group|Group of subjects who underwent RNS® System implantation who were randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the blinded Evaluation Period). Stimulation may have been enabled after transition into the Follow-Up Period (5th month post-implant) and may have continued for the remainder of the subject's participation in the study.
1253762|NCT00079781|E1|Reported Event|Treatment Population|Open Label Group and Treatment Group combined.
1253763|NCT00079677|B3|Baseline|Total|Total of all reporting groups
1253764|NCT00079677|B2|Baseline|Placebo|Matching placebo tablets once daily
1253765|NCT00079677|B1|Baseline|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
1253766|NCT00079677|P2|Participant Flow|Placebo|Matching placebo tablets once daily
1253767|NCT00079677|P1|Participant Flow|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
1253768|NCT00079677|O2|Outcome|Placebo|Matching placebo tablets once daily
1253769|NCT00079677|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
1253770|NCT00079677|O2|Outcome|Placebo|Matching placebo tablets once daily
1253771|NCT00079677|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
1253772|NCT00079677|E2|Reported Event|Placebo|Matching placebo tablets once daily
1253773|NCT00079677|E1|Reported Event|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
1253774|NCT00079417|B1|Baseline|Vincristine Sulfate and Carboplatin and Surgery|Patients receive chemoreduction comprising carboplatin IV (Pts < 36 months: 18.6 mg/kg Pts ≥ 36 months: 560 mg/m2) over 60 minutes followed by vincristine sulfate IV (Pts < 36 months: 0.05 mg/kg Pts ≥36 months: 1.5 mg/m2) over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local infrared laser therapy, cryosurgery, and/or radiation therapy (radioactive) plaque comprising iodine I 125 or ruthenium Ru 106.
1253775|NCT00079417|P1|Participant Flow|Vincristine Sulfate and Carboplatin and Surgery|"Patients receive chemoreduction comprising carboplatin IV (Pts < 36 months: 18.6 mg/kg Pts ≥ 36 months: 560 mg/m2) over 60 minutes followed by vincristine sulfate IV (Pts < 36 months: 0.05 mg/kg Pts ≥36 months: 1.5 mg/m2) over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local infrared laser therapy, cryosurgery, and/or radiation therapy (radioactive) plaque comprising iodine I 125 or ruthenium Ru 106.~cryosurgery: Application of extreme cold to destroy abnormal or diseased tissue.~infrared laser therapy: Laser therapy or “photobiomodulation” is the use of specific wavelength of light (red and near-infrared) to create therapeutic effects~iodine I 125: Undergo radioactive therapy~ruthenium Ru 106: Undergo radioactive therapy~carboplatin: Given IV~vincristine sulfate: Given IV"
1253820|NCT00079274|B4|Baseline|Arm D (Combination Chemotherapy, Monoclonal Antibody)|"Patients received cetuximab IV over 1 hour on days 1 and 8 and oxaliplatin, leucovorin calcium, and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~cetuximab: Given IV"
1253876|NCT00078949|B5|Baseline|Total|Total of all reporting groups
1253877|NCT00078949|B4|Baseline|Observation|Patients undergo observation only.
1254081|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
1253776|NCT00079417|O1|Outcome|Vincristine Sulfate and Carboplatin and Surgery|"Patients receive chemoreduction comprising carboplatin IV (Pts < 36 months: 18.6 mg/kg Pts ≥ 36 months: 560 mg/m2) over 60 minutes followed by vincristine sulfate IV (Pts < 36 months: 0.05 mg/kg Pts ≥36 months: 1.5 mg/m2) over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local infrared laser therapy, cryosurgery, and/or radiation therapy (radioactive) plaque comprising iodine I 125 or ruthenium Ru 106.~cryosurgery: Application of extreme cold to destroy abnormal or diseased tissue.~infrared laser therapy: Laser therapy or “photobiomodulation” is the use of specific wavelength of light (red and near-infrared) to create therapeutic effects~iodine I 125: Undergo radioactive therapy~ruthenium Ru 106: Undergo radioactive therapy~carboplatin: Given IV~vincristine sulfate: Given IV"
1253777|NCT00079417|E1|Reported Event|Vincristine Sulfate and Carboplatin and Surgery|Patients receive chemoreduction comprising carboplatin IV (Pts < 36 months: 18.6 mg/kg Pts ≥ 36 months: 560 mg/m2) over 60 minutes followed by vincristine sulfate IV (Pts < 36 months: 0.05 mg/kg Pts ≥36 months: 1.5 mg/m2) over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local infrared laser therapy, cryosurgery, and/or radiation therapy (radioactive) plaque comprising iodine I 125 or ruthenium Ru 106.
1253778|NCT00079391|B1|Baseline|Bone Marrow Transplantation Using Nexell Isolex 300i|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
1253779|NCT00079391|P1|Participant Flow|"Bone Marrow Transplantation Using Nexell Isolex 300i"|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. cluster of differentiation 34 (CD34) selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
1253808|NCT00079326|B1|Baseline|Cohort 1: No Prior Chemo or Trastuzumab Treatment|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1253780|NCT00079391|O1|Outcome|Bone Marrow Transplantation Using Nexell Isolex 300i|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
1253781|NCT00079391|O1|Outcome|"Bone Marrow Transplantation Using Nexell Isolex 300i"|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
1253782|NCT00079391|O1|Outcome|"Bone Marrow Transplantation Using Nexell Isolex 300i"|"Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. Cluster of differentiation 34 (CD34) selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant."
1253783|NCT00079391|O1|Outcome|Bone Marrow Transplantation Using Nexell Isolex 300i|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
1253784|NCT00079391|O1|Outcome|Bone Marrow Transplantation Using Nexell Isolex 300i|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
1253785|NCT00079391|O1|Outcome|Bone Marrow Transplantation Using Nexell Isolex 300i|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
1253786|NCT00079391|E1|Reported Event|Bone Marrow Transplantation Using Nexell Isolex 300i|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
1253787|NCT00079339|B4|Baseline|Total|Total of all reporting groups
1253788|NCT00079339|B3|Baseline|Tipifarnib 150-mg/m2|"Tipifarnib 150 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~All participants treated at this dose level were enrolled to the phase I part of the study only."
1253821|NCT00079274|B3|Baseline|Arm C (Combination Chemotherapy)|"Patients received the same treatment as in arm A for 6 courses followed by the same treatment as in arm B for 6 courses (total of 12 courses). Treatment continues in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
1254354|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
1253789|NCT00079339|B2|Baseline|Tipifarnib 125-mg/m2|"Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II."
1253790|NCT00079339|B1|Baseline|Tipifarnib 100-mg/m2|"Tipifarnib 100 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~All participants treated at this dose level were enrolled to the phase I part of the study only."
1253791|NCT00079339|P3|Participant Flow|Tipifarnib 150-mg/m2|"Tipifarnib 150 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~All participants treated at this dose level were enrolled to the phase I part of the study only."
1253792|NCT00079339|P2|Participant Flow|Tipifarnib 125-mg/m2|"Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II."
1253809|NCT00079326|P2|Participant Flow|Cohort 2: 1-2 Prior Trastuzumab Treatment Regimens|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1253793|NCT00079339|P1|Participant Flow|Tipifarnib 100-mg/m2|"Tipifarnib 100 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~All participants treated at this dose level were enrolled to the phase I part of the study only."
1253794|NCT00079339|O1|Outcome|Tipifarnib - All Dose Levels|Participants treated at any dose level who had a baseline positron emission tomography (PET) scan.
1253795|NCT00079339|O1|Outcome|Tipifarnib - All Dose Levels|Participants treated at any dose level who had a baseline positron emission tomography (PET) scan.
1253796|NCT00079339|O1|Outcome|Tipifarnib - All Dose Levels|Participants treated at any dose level who had the baseline and on treatment (two weeks post completion of radiation) MRI scan.
1253797|NCT00079339|O1|Outcome|Tipifarnib - All Dose Levels|Participants treated at any dose level who had the baseline and on treatment (two weeks post completion of radiation) MRI diffusion scan.
1253798|NCT00079339|O1|Outcome|Tipifarnib - Any Dose Level|Participants treated at any dose level who had the baseline and on treatment (two weeks post completion of radiation) MRI perfusion scan.
1253799|NCT00079339|O1|Outcome|Tipifarnib 125-mg/m2|"Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II."
1253800|NCT00079339|O3|Outcome|Tipifarnib 150-mg/m2|"Tipifarnib 150 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~All participants treated at this dose level were enrolled to the phase I part of the study."
1253822|NCT00079274|B2|Baseline|Arm B (Combination Chemotherapy)|"Patients received irinotecan IV over 2 hours on day 1 and leucovorin calcium and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
1253823|NCT00079274|B1|Baseline|Arm A (Combination Chemotherapy)|"Patients received oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours on days 1. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
1253801|NCT00079339|O2|Outcome|Tipifarnib 125-mg/m2|"Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II."
1253802|NCT00079339|O1|Outcome|Tipifarnib 100-mg/m2|"Tipifarnib 100 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~All participants treated at this dose level were enrolled to the phase I part of the study."
1253803|NCT00079339|E3|Reported Event|Tipifarnib 150-mg/m2|"Tipifarnib 150 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~All participants treated at this dose level were enrolled to the phase I part of the study only."
1253804|NCT00079339|E2|Reported Event|Tipifarnib 125-mg/m2|"Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II."
1253805|NCT00079339|E1|Reported Event|Tipifarnib 100-mg/m2|"Tipifarnib 100 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~All participants treated at this dose level were enrolled to the phase I part of the study only."
1253806|NCT00079326|B3|Baseline|Total|Total of all reporting groups
1253807|NCT00079326|B2|Baseline|Cohort 2: 1-2 Prior Trastuzumab Treatment Regimens|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1253810|NCT00079326|P1|Participant Flow|Cohort 1: No Prior Chemo or Trastuzumab Treatment|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1253811|NCT00079326|O2|Outcome|Cohort 2: 1-2 Prior Trastuzumab Treatment Regimens|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1253812|NCT00079326|O1|Outcome|Cohort 1: No Prior Chemo or Trastuzumab Treatment|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1253813|NCT00079326|O2|Outcome|Cohort 2: 1-2 Prior Trastuzumab Treatment Regimens|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1253814|NCT00079326|O1|Outcome|Cohort 1: No Prior Chemo or Trastuzumab Treatment|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
1253815|NCT00079326|E1|Reported Event|All Study Participants|All Adverse Events and Serious Adverse event data was pooled because all participants received the same treatment.
1253816|NCT00079274|B8|Baseline|Total|Total of all reporting groups
1253817|NCT00079274|B7|Baseline|Arm G (Locally Directed Therapy)|"Patients determined to have mutated KRAS (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists.~Locally Directed Therapy: Patients determined to have mutated KRAS (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists."
1253818|NCT00079274|B6|Baseline|Arm F (Combination Chemotherapy, Monoclonal Antibody)|"Patients received cetuximab as in arm D and chemotherapy as in arm C.~irinotecan hydrochloride: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~cetuximab: Given IV"
1253819|NCT00079274|B5|Baseline|Arm E (Combination Chemotherapy, Monoclonal Antibody)|"Patients received cetuximab as in arm D and irinotecan, leucovorin calcium, and fluorouracil as in arm B. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~cetuximab: Given IV"
1254082|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
1253824|NCT00079274|P7|Participant Flow|Arm G (Locally Directed Therapy)|"Patients determined to have mutated Kirsten rat sarcoma (KRAS) (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists.~Locally Directed Therapy: Patients determined to have mutated KRAS (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists."
1253825|NCT00079274|P6|Participant Flow|Arm F (Combination Chemotherapy, Monoclonal Antibody)|"Patients received cetuximab as in arm D and chemotherapy as in arm C.~irinotecan hydrochloride: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~cetuximab: Given IV"
1253826|NCT00079274|P5|Participant Flow|Arm E (Combination Chemotherapy, Monoclonal Antibody)|"Patients received cetuximab as in arm D and irinotecan, leucovorin calcium, and fluorouracil as in arm B. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~leucovorin calcium: Given IV~fluorouracil: Given I~cetuximab: Given IV"
1253827|NCT00079274|P4|Participant Flow|Arm D (Combination Chemotherapy, Monoclonal Antibody)|"Patients received cetuximab IV over 1 hour on days 1 and 8 and oxaliplatin, leucovorin calcium, and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~cetuximab: Given IV"
1253828|NCT00079274|P3|Participant Flow|Arm C (Combination Chemotherapy)|"Patients received the same treatment as in arm A for 6 courses followed by the same treatment as in arm B for 6 courses (total of 12 courses). Treatment continues in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
1253829|NCT00079274|P2|Participant Flow|Arm B (Combination Chemotherapy)|"Patients received irinotecan IV over 2 hours on day 1 and leucovorin calcium and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
1254038|NCT00078377|O2|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
1253830|NCT00079274|P1|Participant Flow|Arm A (Combination Chemotherapy)|"Patients received oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours on days 1. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
1253831|NCT00079274|O2|Outcome|Mutant KRAS Arm D|Patients from Arm D (and a few patients from Arm F that did not receive irinotecan) that are mutant KRAS and concurrently randomized with Arm A patients.
1253832|NCT00079274|O1|Outcome|Mutant KRAS Arm A|Patients from Arm A (and a few patients from Arm C that did not receive irinotecan) that are mutant KRAS and concurrently randomized with Arm D patients.
1253833|NCT00079274|O2|Outcome|Wild-type KRAS Arm D|Patients from Arm D (and a few patients from Arm F that did not receive irinotecan) that are wild-type KRAS and concurrently randomized with Arm A patients.
1253834|NCT00079274|O1|Outcome|Wild-type KRAS Arm A|Patients from Arm A (and a few patients from Arm C that did not receive irinotecan) that are wild-type KRAS and concurrently randomized with Arm D patients.
1253835|NCT00079274|E7|Reported Event|Arm G (Locally Directed Therapy)|"Patients determined to have mutated KRAS (or KRAS not evaluable) will be assigned to an event monitoring arm in which adjuvant therapy will be determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification will be the responsibility of the treating oncologists.~Locally Directed Therapy: Patients determined to have mutated KRAS (or KRAS not evaluable) will be assigned to an event monitoring arm in which adjuvant therapy will be determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification will be the responsibility of the treating oncologists."
1253836|NCT00079274|E6|Reported Event|Arm F (Combination Chemotherapy, Monoclonal Antibody)|"Patients receive cetuximab as in arm D and chemotherapy as in arm C.~irinotecan hydrochloride: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~cetuximab: Given IV"
1253837|NCT00079274|E5|Reported Event|Arm E (Combination Chemotherapy, Monoclonal Antibody)|"Patients receive cetuximab as in arm D and irinotecan, leucovorin calcium, and fluorouracil as in arm B. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~cetuximab: Given IV"
1253838|NCT00079274|E4|Reported Event|Arm D (Combination Chemotherapy, Monoclonal Antibody)|"Patients receive cetuximab IV over 1 hour on days 1 and 8 and oxaliplatin, leucovorin calcium, and fluorouracil as in arm A. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~cetuximab: Given IV"
1253839|NCT00079274|E3|Reported Event|Arm C (Combination Chemotherapy)|"Patients receive the same treatment as in arm A for 6 courses followed by the same treatment as in arm B for 6 courses (total of 12 courses). Treatment continues in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
1253840|NCT00079274|E2|Reported Event|Arm B (Combination Chemotherapy)|"Patients receive irinotecan IV over 2 hours on day 1 and leucovorin calcium and fluorouracil as in arm A. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
1253841|NCT00079274|E1|Reported Event|Arm A (Combination Chemotherapy)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours on days 1. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
1253873|NCT00079001|O1|Outcome|Zoledronic Acid + Androgen Deprivation Therapy|4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
1253842|NCT00079183|B1|Baseline|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
1253843|NCT00079183|P1|Participant Flow|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
1253844|NCT00079183|O1|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
1253845|NCT00079183|O1|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
1253846|NCT00079183|O1|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
1253847|NCT00079183|O1|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
1253848|NCT00079183|O1|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
1253849|NCT00079183|O1|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
1253850|NCT00079183|O1|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
1253851|NCT00079183|O1|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
1253852|NCT00079183|O1|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
1253874|NCT00079001|E2|Reported Event|Placebo + Androgen Deprivation Therapy|Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
1253878|NCT00078949|B3|Baseline|Maintenance|"Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV"
1253853|NCT00079183|O1|Outcome|Sirolimus|"Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.~sirolimus: Given PO~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
1253854|NCT00079183|O1|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
1253855|NCT00079183|O1|Outcome|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
1253856|NCT00079183|E1|Reported Event|Sirolimus|Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
1253857|NCT00079040|B1|Baseline|Cisplatin, Etoposide, Bevacizumab|Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
1253858|NCT00079040|P1|Participant Flow|Cisplatin, Etoposide, Bevacizumab|Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
1253859|NCT00079040|O1|Outcome|Cisplatin, Etoposide, Bevacizumab|Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
1253860|NCT00079040|O1|Outcome|Cisplatin, Etoposide, Bevacizumab|Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
1253861|NCT00079040|O1|Outcome|Cisplatin, Etoposide, Bevacizumab|Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
1253862|NCT00079040|E1|Reported Event|Cisplatin, Etoposide, Bevacizumab|Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
1253863|NCT00079001|B3|Baseline|Total|Total of all reporting groups
1253864|NCT00079001|B2|Baseline|Placebo + Androgen Deprivation Therapy|Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
1253865|NCT00079001|B1|Baseline|Zoledronic Acid + Androgen Deprivation Therapy|4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
1253866|NCT00079001|P2|Participant Flow|Placebo + Androgen Deprivation Therapy|Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
1253867|NCT00079001|P1|Participant Flow|Zoledronic Acid + Androgen Deprivation Therapy|4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
1253868|NCT00079001|O2|Outcome|Placebo + Androgen Deprivation Therapy|Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
1253869|NCT00079001|O1|Outcome|Zoledronic Acid + Androgen Deprivation Therapy|4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
1253870|NCT00079001|O2|Outcome|Placebo + Androgen Deprivation Therapy|Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
1253871|NCT00079001|O1|Outcome|Zoledronic Acid + Androgen Deprivation Therapy|4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
1253872|NCT00079001|O2|Outcome|Placebo + Androgen Deprivation Therapy|Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
1253879|NCT00078949|B2|Baseline|Salvage DHAP|"Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2.~cisplatin: Given IV~cytarabine: Given IV~dexamethasone: Given IV"
1253880|NCT00078949|B1|Baseline|Salvage GDP|"Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8.~cisplatin: Given IV~dexamethasone: Given IV~gemcitabine hydrochloride: Given IV"
1253881|NCT00078949|P4|Participant Flow|Observation|Patients undergo observation only.
1253882|NCT00078949|P3|Participant Flow|Maintenance|"Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV"
1253883|NCT00078949|P2|Participant Flow|Salvage DHAP|"Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2.~cisplatin: Given IV~cytarabine: Given IV~dexamethasone: Given IV"
1253884|NCT00078949|P1|Participant Flow|Salvage GDP|"Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8.~cisplatin: Given IV~dexamethasone: Given IV~gemcitabine hydrochloride: Given IV"
1253885|NCT00078949|O2|Outcome|Observation|Patients undergo observation only.
1253886|NCT00078949|O1|Outcome|Maintenance|"Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV"
1253887|NCT00078949|O2|Outcome|Salvage DHAP|"Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2.~cisplatin: Given IV~cytarabine: Given IV~dexamethasone: Given IV"
1254039|NCT00078377|O1|Outcome|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
1253888|NCT00078949|O1|Outcome|Salvage GDP|"Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8.~cisplatin: Given IV~dexamethasone: Given IV~gemcitabine hydrochloride: Given IV"
1253889|NCT00078949|O2|Outcome|Salvage DHAP|"Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2.~cisplatin: Given IV~cytarabine: Given IV~dexamethasone: Given IV"
1253890|NCT00078949|O1|Outcome|Salvage GDP|"Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8.~cisplatin: Given IV~dexamethasone: Given IV~gemcitabine hydrochloride: Given IV"
1253891|NCT00078949|E4|Reported Event|Observation|Patients undergo observation only.
1253892|NCT00078949|E3|Reported Event|Maintenance|"Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV"
1253893|NCT00078949|E2|Reported Event|Salvage DHAP|"Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2.~cisplatin: Given IV~cytarabine: Given IV~dexamethasone: Given IV"
1253894|NCT00078949|E1|Reported Event|Salvage GDP|"Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8.~cisplatin: Given IV~dexamethasone: Given IV~gemcitabine hydrochloride: Given IV"
1253895|NCT00078767|B3|Baseline|Total|Total of all reporting groups
1253896|NCT00078767|B2|Baseline|TF-CBT +Placebo|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT~Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT"
1253897|NCT00078767|B1|Baseline|TF-CBT + Sertraline|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day~Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT"
1253898|NCT00078767|P2|Participant Flow|TF-CBT +Placebo|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT~Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT"
1253899|NCT00078767|P1|Participant Flow|TF-CBT + Sertraline|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day~Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT"
1253900|NCT00078767|O2|Outcome|TF-CBT +Placebo|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT~Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT"
1253916|NCT00078754|P3|Participant Flow|Group C - Placebo|"Participants will to receive treatment with placebo for 12 weeks~Placebo: Placebo capsules by mouth, up to 8 capsules daily"
1254355|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
1253901|NCT00078767|O1|Outcome|TF-CBT + Sertraline|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day~Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT"
1253902|NCT00078767|O2|Outcome|TF-CBT +Placebo|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT~Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT"
1253903|NCT00078767|O1|Outcome|TF-CBT + Sertraline|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day~Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT"
1253904|NCT00078767|O2|Outcome|TF-CBT +Placebo|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT~Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT"
1254040|NCT00078377|O4|Outcome|Armodafinil Combined Group (250 mg/Day and 150 mg/Day)|
1253905|NCT00078767|O1|Outcome|TF-CBT + Sertraline|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day~Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT"
1253906|NCT00078767|O2|Outcome|TF-CBT +Placebo|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT~Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT"
1253907|NCT00078767|O1|Outcome|TF-CBT + Sertraline|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day~Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT"
1253908|NCT00078767|O2|Outcome|TF-CBT +Placebo|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT~Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT"
1253909|NCT00078767|O1|Outcome|TF-CBT + Sertraline|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day~Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT"
1253910|NCT00078767|E2|Reported Event|TF-CBT +Placebo|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT~Placebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT"
1253911|NCT00078767|E1|Reported Event|TF-CBT + Sertraline|"Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day~Trauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent~Sertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT"
1253912|NCT00078754|B4|Baseline|Total|Total of all reporting groups
1253913|NCT00078754|B3|Baseline|Group C - Placebo|"Participants will to receive treatment with placebo for 12 weeks~Placebo: Placebo capsules by mouth, up to 8 capsules daily"
1253914|NCT00078754|B2|Baseline|Group B - Divalproex Drug|"Participants will to receive treatment with divalproex for 12 weeks~Divalproex: Divalproex ER capsules by mouth, up to 3000 mg daily"
1253915|NCT00078754|B1|Baseline|Group A - Fluoxetine Drug|"Participants will to receive treatment with fluoxetine for 12 weeks~Fluoxetine: Fluoxetine capsules by mouth, up to 60 mg daily"
1253917|NCT00078754|P2|Participant Flow|Group B - Divalproex Drug|"Participants will to receive treatment with divalproex for 12 weeks~Divalproex: Divalproex ER capsules by mouth, up to 3000 mg daily"
1253918|NCT00078754|P1|Participant Flow|Group A - Fluoxetine Drug|"Participants will to receive treatment with fluoxetine for 12 weeks~Fluoxetine: Fluoxetine capsules by mouth, up to 60 mg daily"
1253919|NCT00078754|O3|Outcome|Group C - Placebo|"Participants will to receive treatment with placebo for 12 weeks~Placebo: Placebo capsules by mouth, up to 8 capsules daily"
1253920|NCT00078754|O2|Outcome|Group B - Divalproex Drug|"Participants will to receive treatment with divalproex for 12 weeks~Divalproex: Divalproex ER capsules by mouth, up to 3000 mg daily"
1253921|NCT00078754|O1|Outcome|Group A - Fluoxetine Drug|"Participants will to receive treatment with fluoxetine for 12 weeks~Fluoxetine: Fluoxetine capsules by mouth, up to 60 mg daily"
1253922|NCT00078754|E3|Reported Event|Group C - Placebo|"Participants will to receive treatment with placebo for 12 weeks~Placebo: Placebo capsules by mouth, up to 8 capsules daily"
1253923|NCT00078754|E2|Reported Event|Group B - Divalproex Drug|"Participants will to receive treatment with divalproex for 12 weeks~Divalproex: Divalproex ER capsules by mouth, up to 3000 mg daily"
1253924|NCT00078754|E1|Reported Event|Group A - Fluoxetine Drug|"Participants will to receive treatment with fluoxetine for 12 weeks~Fluoxetine: Fluoxetine capsules by mouth, up to 60 mg daily"
1253925|NCT00078728|B3|Baseline|Total|Total of all reporting groups
1253926|NCT00078728|B2|Baseline|2 Evaluation Only|Evaluation only : Participants will undergo evaluations without active treatment for 8 weeks.
1253927|NCT00078728|B1|Baseline|1 Family-based Prevention Program|Family-Based Anxiety Prevention Program : Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks.
1253928|NCT00078728|P2|Participant Flow|2 Evaluation Only|Evaluation only : Participants will undergo evaluations without active treatment for 8 weeks.
1254041|NCT00078377|O3|Outcome|Placebo|Matching placebo tablets once daily in the morning
1253929|NCT00078728|P1|Participant Flow|1 Family-based Prevention Program|Family-Based Anxiety Prevention Program : Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks.
1253930|NCT00078728|O2|Outcome|2 Evaluation Only|Evaluation only : Participants will undergo evaluations without active treatment for 8 weeks.
1253931|NCT00078728|O1|Outcome|1 Family-based Prevention Program|Family-Based Anxiety Prevention Program : Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks.
1253932|NCT00078728|E2|Reported Event|2 Evaluation Only|Evaluation only : Participants will undergo evaluations without active treatment for 8 weeks.
1253933|NCT00078728|E1|Reported Event|1 Family-based Prevention Program|Family-Based Anxiety Prevention Program : Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks.
1253934|NCT00078715|B1|Baseline|Overall Study|
1253935|NCT00078715|P2|Participant Flow|Yohimbine Then Placebo|Participants are randomized to blindly receive yohimbine for 8 days then placebo for the same.
1253936|NCT00078715|P1|Participant Flow|Placebo Then Yohimbine|Participants are randomized to blindly receive placebo for 8 days then yohimbine for the same.
1253937|NCT00078715|O2|Outcome|Yohimbine|Participants are randomized to blindly receive yohimbine for 8 days.
1253938|NCT00078715|O1|Outcome|Placebo|Participants are randomized to blindly receive placebo for 8 days.
1253939|NCT00078715|E2|Reported Event|Yohimbine|
1253940|NCT00078715|E1|Reported Event|Placebo|
1253941|NCT00078559|B1|Baseline|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
1253942|NCT00078559|P1|Participant Flow|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
1253943|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
1253944|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
1253945|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
1254079|NCT00077974|P1|Participant Flow|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
1253946|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
1253947|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
1253948|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
1253949|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
1254042|NCT00078377|O2|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
1254043|NCT00078377|O1|Outcome|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
1253950|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
1253951|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
1253952|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
1253953|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
1253954|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
1253955|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
1253956|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
1253957|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
1254356|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
1253958|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
1253959|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
1253960|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
1253961|NCT00078559|O1|Outcome|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
1253994|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
1253962|NCT00078559|O1|Outcome|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
1253963|NCT00078559|O1|Outcome|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
1253964|NCT00078559|O1|Outcome|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
1253965|NCT00078559|O1|Outcome|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
1253966|NCT00078559|E1|Reported Event|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
1253967|NCT00078403|B4|Baseline|Total|Total of all reporting groups
1253968|NCT00078403|B3|Baseline|OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
1253969|NCT00078403|B2|Baseline|OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
1253970|NCT00078403|B1|Baseline|Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
1254021|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
1253971|NCT00078403|P3|Participant Flow|OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
1253972|NCT00078403|P2|Participant Flow|OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
1253973|NCT00078403|P1|Participant Flow|Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
1253974|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
1253975|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
1253976|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
1253995|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
1254044|NCT00078377|E3|Reported Event|Placebo|Matching placebo tablets once daily in the morning
1253977|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
1253978|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
1253979|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
1253980|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation..
1253981|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
1253982|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
1253983|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
1253984|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
1253985|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
1254078|NCT00077974|B1|Baseline|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
1254080|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
1253986|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
1253987|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
1253988|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
1253989|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
1253990|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
1253991|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
1253992|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
1253993|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
1254029|NCT00078377|B4|Baseline|Total|Total of all reporting groups
1253996|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
1253997|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
1253998|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
1253999|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
1254000|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
1254001|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
1254002|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
1254003|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
1254004|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
1254005|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
1254006|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
1254007|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
1254008|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
1254009|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
1254010|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
1254011|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
1254030|NCT00078377|B3|Baseline|Placebo|Matching placebo tablets once daily in the morning
1254031|NCT00078377|B2|Baseline|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
1254032|NCT00078377|B1|Baseline|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
1254012|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
1254013|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
1254014|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
1254015|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
1254016|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
1254017|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
1254018|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
1254019|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
1254020|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
1254022|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
1254023|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
1254024|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
1254025|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
1254026|NCT00078403|E3|Reported Event|OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to be HCV RNA negative (HCV RNA < 60 IU/mL) or had more than a 2 log decrease in HCV RNA from Baseline. Participants were assigned to remain in the Open Label (OL) part of the study continuing the run-in treatment (PEG-IFN 180 mcg weekly & ribavirin [RBV] 1-1.2 g/day based on weight). At the beginning of week 36, participants were retested and, if found to be HCV RNA positive (HCV RNA > 60 IU/mL), participants could be randomized to OL PEG-IFN or Observation.
1254027|NCT00078403|E2|Reported Event|OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to be followed on the Observation (no treatment) Arm.
1254028|NCT00078403|E1|Reported Event|Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to receive the pegylated interferon (PEG-IFN) 180 mcg weekly Arm.
1254045|NCT00078377|E2|Reported Event|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
1254046|NCT00078377|E1|Reported Event|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
1254047|NCT00078325|B4|Baseline|Total|Total of all reporting groups
1254048|NCT00078325|B3|Baseline|Placebo|Matching placebo tablets once daily
1254049|NCT00078325|B2|Baseline|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
1254050|NCT00078325|B1|Baseline|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
1254051|NCT00078325|P3|Participant Flow|Placebo|Matching placebo tablets once daily
1254052|NCT00078325|P2|Participant Flow|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
1254053|NCT00078325|P1|Participant Flow|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
1254054|NCT00078325|O3|Outcome|Placebo|Matching placebo tablets once daily
1254055|NCT00078325|O2|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
1254056|NCT00078325|O1|Outcome|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
1254057|NCT00078325|O3|Outcome|Placebo|Matching placebo tablets once daily
1254058|NCT00078325|O2|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
1254059|NCT00078325|O1|Outcome|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
1254060|NCT00078325|E3|Reported Event|Placebo|Matching placebo tablets once daily
1254061|NCT00078325|E2|Reported Event|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
1254062|NCT00078325|E1|Reported Event|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
1254063|NCT00078312|B1|Baseline|Armodafinil 100 to 250 mg/Day|Participants with narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS): armodafinil once daily in the morning. Participants with chronic Shift Work Sleep Disorder (SWSD): armodafinil 100-250 mg once daily only on nights worked
1254064|NCT00078312|P1|Participant Flow|Armodafinil 100 to 250 mg/Day|Participants with narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS): armodafinil once daily in the morning. Participants with chronic Shift Work Sleep Disorder (SWSD): armodafinil 100-250 mg once daily only on nights worked
1254065|NCT00078312|O1|Outcome|Armodafinil 100 to 250 mg/Day|Participants with narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS): armodafinil once daily in the morning. Participants with chronic Shift Work Sleep Disorder (SWSD): armodafinil 100-250 mg once daily only on nights worked
1254066|NCT00078312|E1|Reported Event|Armodafinil 100 to 250 mg/Day|Participants with narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS): armodafinil once daily in the morning. Participants with chronic Shift Work Sleep Disorder (SWSD): armodafinil 100-250 mg once daily only on nights worked
1254067|NCT00078286|B3|Baseline|Total|Total of all reporting groups
1254068|NCT00078286|B2|Baseline|Placebo|Participants will take placebo for 12 weeks
1254069|NCT00078286|B1|Baseline|Sertraline|Participants will take sertraline for 12 weeks
1254070|NCT00078286|P2|Participant Flow|Placebo|Participants will take placebo for 12 weeks
1254071|NCT00078286|P1|Participant Flow|Sertraline|Participants will take sertraline for 12 weeks
1254072|NCT00078286|O2|Outcome|Placebo|Participants will take placebo for 12 weeks
1254073|NCT00078286|O1|Outcome|Sertraline|Participants will take sertraline for 12 weeks
1254074|NCT00078286|O2|Outcome|Placebo|Participants will take placebo for 12 weeks
1254075|NCT00078286|O1|Outcome|Sertraline|Participants will take sertraline for 12 weeks
1254076|NCT00078286|E2|Reported Event|Placebo|Serious adverse events in Placebo Arm
1254077|NCT00078286|E1|Reported Event|Sertraline|Serious adverse events in Sertraline Arm
1254083|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
1254084|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
1254085|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
1254086|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
1254087|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
1254088|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
1254089|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
1254090|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
1254091|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
1254092|NCT00077974|E1|Reported Event|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
1254093|NCT00077922|B1|Baseline|LMB-2 in Chronic Lymphocytic Leukemia|40 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with chronic lymphocytic leukemia, the most prevalent form of adult leukemia.
1254365|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
1254094|NCT00077922|P1|Participant Flow|LMB-2 in Chronic Lymphocytic Leukemia|40 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with chronic lymphocytic leukemia, the most prevalent form of adult leukemia.
1254095|NCT00077922|O1|Outcome|LMB-2 in Chronic Lymphocytic Leukemia|40 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with chronic lymphocytic leukemia, the most prevalent form of adult leukemia.
1254096|NCT00077922|O1|Outcome|LMB-2 in Chronic Lymphocytic Leukemia|40 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with chronic lymphocytic leukemia, the most prevalent form of adult leukemia.
1254097|NCT00077922|E1|Reported Event|LMB-2 in Chronic Lymphocytic Leukemia|40 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with chronic lymphocytic leukemia, the most prevalent form of adult leukemia.
1254098|NCT00077857|B3|Baseline|Total|Total of all reporting groups
1254099|NCT00077857|B2|Baseline|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
1254100|NCT00077857|B1|Baseline|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
1254101|NCT00077857|P2|Participant Flow|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
1254102|NCT00077857|P1|Participant Flow|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
1254103|NCT00077857|O2|Outcome|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
1254104|NCT00077857|O1|Outcome|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
1254105|NCT00077857|O2|Outcome|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
1254106|NCT00077857|O1|Outcome|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
1254107|NCT00077857|O2|Outcome|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
1254108|NCT00077857|O1|Outcome|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
1254109|NCT00077857|O2|Outcome|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
1254110|NCT00077857|O1|Outcome|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
1254111|NCT00077857|O2|Outcome|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
1254112|NCT00077857|O1|Outcome|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
1254113|NCT00077857|O2|Outcome|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
1254114|NCT00077857|O1|Outcome|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
1254115|NCT00077857|O2|Outcome|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
1254116|NCT00077857|O1|Outcome|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
1254117|NCT00077857|E2|Reported Event|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
1254118|NCT00077857|E1|Reported Event|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
1254119|NCT00077766|B3|Baseline|Total|Total of all reporting groups
1254120|NCT00077766|B2|Baseline|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
1254121|NCT00077766|B1|Baseline|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
1254122|NCT00077766|P2|Participant Flow|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
1254123|NCT00077766|P1|Participant Flow|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) intravenously (IV), every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 microgram [µg]) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
1254124|NCT00077766|O2|Outcome|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
1254125|NCT00077766|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
1254126|NCT00077766|O2|Outcome|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
1254127|NCT00077766|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
1254128|NCT00077766|O2|Outcome|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
1254129|NCT00077766|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
1254130|NCT00077766|O2|Outcome|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
1254131|NCT00077766|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
1254132|NCT00077766|O2|Outcome|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
1254133|NCT00077766|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
1254134|NCT00077766|O2|Outcome|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
1254135|NCT00077766|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
1254136|NCT00077766|O2|Outcome|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
1254137|NCT00077766|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Weeks 1 through 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
1254138|NCT00077766|E2|Reported Event|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
1254139|NCT00077766|E1|Reported Event|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
1254140|NCT00077675|B3|Baseline|Total|Total of all reporting groups
1254141|NCT00077675|B2|Baseline|Standard of Care for cSSSI|Standard therapy [nafcillin or oxacillin 2 gram, or cloxacillin (in S. Africa) 0.5 to 1.0 gram, every 6 hours, or vancomycin 1 gram every 12 hours, intravenously]
1254142|NCT00077675|B1|Baseline|Telavancin|Telavancin 10 mg/kg every 24 hours intravenously
1254143|NCT00077675|P2|Participant Flow|Standard of Care for cSSSI|Standard therapy [nafcillin or oxacillin 2 gram, or cloxacillin (in S. Africa) 0.5 to 1.0 gram, every 6 hours, or vancomycin 1 gram every 12 hours, intravenously]
1254144|NCT00077675|P1|Participant Flow|Telavancin|Telavancin 10 mg/kg every 24 hours intravenously
1254145|NCT00077675|O2|Outcome|Standard of Care for cSSSI|Standard therapy [nafcillin or oxacillin 2 gram, or cloxacillin (in S. Africa) 0.5 to 1.0 gram, every 6 hours, or vancomycin 1 gram every 12 hours, intravenously]
1254146|NCT00077675|O1|Outcome|Telavancin|Telavancin 10 mg/kg every 24 hours intravenously
1254147|NCT00077675|E2|Reported Event|Standard of Care for cSSSI|Standard therapy [nafcillin or oxacillin 2 gram, or cloxacillin (in S. Africa) 0.5 to 1.0 gram, every 6 hours, or vancomycin 1 gram every 12 hours, intravenously]
1254148|NCT00077675|E1|Reported Event|Telavancin|Telavancin 10 mg/kg every 24 hours intravenously
1254149|NCT00077649|B5|Baseline|Total|Total of all reporting groups
1254150|NCT00077649|B4|Baseline|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
1254151|NCT00077649|B3|Baseline|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks.
1254152|NCT00077649|B2|Baseline|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
1254153|NCT00077649|B1|Baseline|PEG-IFN Alfa-2a 180 mcg+ Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks.
1254154|NCT00077649|P4|Participant Flow|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
1254155|NCT00077649|P3|Participant Flow|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
1254366|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
1254156|NCT00077649|P2|Participant Flow|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
1254157|NCT00077649|P1|Participant Flow|PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg|Participants received 180 micrograms (mcg) of PEG-IFN [peginterferon] alfa-2a in 1 milliliter (mL) solution administered subcutaneously (SC), once weekly + 1200 milligrams (mg) of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks
1254158|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
1254159|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
1254160|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
1254161|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
1254162|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
1254163|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
1254164|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
1254165|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
1254166|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg+ Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
1254167|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
1254168|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
1254169|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
1254170|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
1254171|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
1254172|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
1254173|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
1254174|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
1254175|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
1254176|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
1254177|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
1254178|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
1254179|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
1254180|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
1254181|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
1254182|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
1254183|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
1254184|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
1254185|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
1254186|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
1254187|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
1254188|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
1254189|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
1254190|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
1254191|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
1254192|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
1254193|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
1254194|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
1254195|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
1254196|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
1254197|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
1254198|NCT00077649|E4|Reported Event|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-ml solution administered sc once in a week + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
1254199|NCT00077649|E3|Reported Event|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-ml solution administered sc once in a week + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
1254357|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
1254200|NCT00077649|E2|Reported Event|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-ml solution administered sc once in a week + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
1254201|NCT00077649|E1|Reported Event|PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-ml solution administered [subcutaneously] sc, once in a week + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks
1254202|NCT00077636|B3|Baseline|Total|Total of all reporting groups
1254203|NCT00077636|B2|Baseline|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
1254204|NCT00077636|B1|Baseline|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
1254205|NCT00077636|P2|Participant Flow|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants received 180 mcg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
1254206|NCT00077636|P1|Participant Flow|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants received 180 micrograms (mcg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
1254207|NCT00077636|O2|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
1254208|NCT00077636|O1|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 16 weeks.
1254209|NCT00077636|O2|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
1254367|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
1254210|NCT00077636|O1|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
1254211|NCT00077636|O2|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
1254212|NCT00077636|O1|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
1254213|NCT00077636|O2|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
1254214|NCT00077636|O1|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
1254215|NCT00077636|O2|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
1254216|NCT00077636|O1|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
1254217|NCT00077636|O2|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
1254218|NCT00077636|O1|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
1254219|NCT00077636|O2|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
1254220|NCT00077636|O1|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
1254221|NCT00077636|E2|Reported Event|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
1254222|NCT00077636|E1|Reported Event|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
1254223|NCT00077623|B4|Baseline|Total|Total of all reporting groups
1254224|NCT00077623|B3|Baseline|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
1254225|NCT00077623|B2|Baseline|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the Epoetin dose of<8000, 8000-16000, or >16000 IU/Week administered during the week preceding the switch to the study drug.
1254226|NCT00077623|B1|Baseline|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the Epoetin dose of<8000, 8000-16000,or >16000 International units [IU]/Week, administered during the week preceding the switch to the study drug.
1254227|NCT00077623|P3|Participant Flow|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
1254228|NCT00077623|P2|Participant Flow|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
1254229|NCT00077623|P1|Participant Flow|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 (Mircera [methoxy polyethylene glycol-epoetin beta]) subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 microgram (mcg) which was based on the epoetin dose of<8000, 8000-16000, or >16000 international units per week (IU/week), administered during the week preceding the switch to the study drug.
1254230|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
1254231|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
1254232|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
1254233|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
1254234|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
1254235|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
1254236|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
1254237|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
1254368|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
1254238|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
1254239|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
1254240|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
1254241|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
1254242|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
1254243|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
1254244|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
1254245|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
1254246|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
1254247|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
1254248|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
1254249|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
1254250|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
1254251|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
1254252|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
1254253|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
1254358|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
1254254|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
1254255|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
1254256|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
1254257|NCT00077623|E3|Reported Event|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
1254258|NCT00077623|E2|Reported Event|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
1254259|NCT00077623|E1|Reported Event|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
1254260|NCT00077610|B4|Baseline|Total|Total of all reporting groups
1254261|NCT00077610|B3|Baseline|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
1254369|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
1254370|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
1254262|NCT00077610|B2|Baseline|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (120, 200, or 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
1254263|NCT00077610|B1|Baseline|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
1254264|NCT00077610|P3|Participant Flow|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
1254265|NCT00077610|P2|Participant Flow|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (120, 200, or 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
1254266|NCT00077610|P1|Participant Flow|RO0503821 (1x/2 Weeks)|Participants received RO0503821 (Mircera [methoxy polyethylene glycol-epoetin beta]) once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 microgram [mcg]) that was based on the Epoetin dose (<8000, 8000-16000, >16000 International units [IU]/Week) administered during the week preceding the switch to the study drug.
1254267|NCT00077610|O3|Outcome|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
1254268|NCT00077610|O2|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose administered during the week preceding the switch to the study drug.
1254269|NCT00077610|O1|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
1254270|NCT00077610|O3|Outcome|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
1254271|NCT00077610|O2|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
1254272|NCT00077610|O1|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
1254273|NCT00077610|O3|Outcome|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
1254274|NCT00077610|O2|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
1254275|NCT00077610|O1|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
1254276|NCT00077610|O3|Outcome|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
1254277|NCT00077610|O2|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
1254359|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
1254278|NCT00077610|O1|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
1254279|NCT00077610|O3|Outcome|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
1254280|NCT00077610|O2|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
1254281|NCT00077610|O1|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
1254282|NCT00077610|O3|Outcome|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks
1254283|NCT00077610|O2|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
1254284|NCT00077610|O1|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
1254285|NCT00077610|O3|Outcome|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
1254371|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
1254286|NCT00077610|O2|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
1254287|NCT00077610|O1|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
1254288|NCT00077610|O3|Outcome|Epoetin (1-3x/Week)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
1254289|NCT00077610|O2|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
1254290|NCT00077610|O1|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 120,180 mcg) that was based on the Epoetin dose administered (<8000, 8000-16000, >16000 IU/Week) during the week preceding the switch to the study drug.
1254291|NCT00077610|E3|Reported Event|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
1254292|NCT00077610|E2|Reported Event|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (120, 200, or 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
1254293|NCT00077610|E1|Reported Event|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
1254294|NCT00077376|B1|Baseline|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
1254295|NCT00077376|P1|Participant Flow|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
1254305|NCT00077207|B1|Baseline|Treatment (Carboplatin, Vincristine Sulfate, Temozolomide)|"Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.~carboplatin: Given IV~temozolomide: Given orally~vincristine sulfate: Given IV"
1254296|NCT00077376|O1|Outcome|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
1254297|NCT00077376|O1|Outcome|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
1254298|NCT00077376|O1|Outcome|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
1254299|NCT00077376|O1|Outcome|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
1254300|NCT00077376|O1|Outcome|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
1254301|NCT00077376|O1|Outcome|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
1254302|NCT00077376|O1|Outcome|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
1254303|NCT00077376|O1|Outcome|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
1254304|NCT00077376|E1|Reported Event|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
1254306|NCT00077207|P1|Participant Flow|Treatment (Carboplatin, Vincristine Sulfate, Temozolomide)|"Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.~carboplatin: Given IV~temozolomide: Given orally~vincristine sulfate: Given IV"
1254307|NCT00077207|O1|Outcome|Treatment (Carboplatin, Vincristine Sulfate, Temozolomide)|"Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.~carboplatin: Given IV~temozolomide: Given orally~vincristine sulfate: Given IV"
1254308|NCT00077207|O1|Outcome|Treatment (Carboplatin, Vincristine Sulfate, Temozolomide)|"Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.~carboplatin: Given IV~temozolomide: Given orally~vincristine sulfate: Given IV"
1254372|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
1254373|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
1254374|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
1254309|NCT00077207|E1|Reported Event|Treatment (Carboplatin, Vincristine Sulfate, Temozolomide)|"Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.~carboplatin: Given IV~temozolomide: Given orally~vincristine sulfate: Given IV"
1254310|NCT00076999|B5|Baseline|Total|Total of all reporting groups
1254311|NCT00076999|B4|Baseline|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
1254312|NCT00076999|B3|Baseline|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
1254313|NCT00076999|B2|Baseline|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
1254314|NCT00076999|B1|Baseline|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
1254315|NCT00076999|P5|Participant Flow|TPV SEDDS 12-18 Yrs|TPV self-emulsifying drug delivery system (SEDDS), ages 12-18
1254316|NCT00076999|P4|Participant Flow|TPV SEDDS 6-<12 Yrs|TPV self-emulsifying drug delivery system (SEDDS), ages 6-11
1254317|NCT00076999|P3|Participant Flow|TPV OS 12-18 Yrs|Tipranavir Oral Solution (TPV OS), ages 12-18
1254318|NCT00076999|P2|Participant Flow|TPV OS 6-<12 Yrs|Tipranavir Oral Solution (TPV OS), ages 6-11
1254319|NCT00076999|P1|Participant Flow|TPV OS 2-<6 Yrs|Tipranavir Oral Solution (TPV OS), ages 2-5
1254320|NCT00076999|O5|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
1254321|NCT00076999|O4|Outcome|TPV SEDDS 6-<12 Yrs|Patients treated with Tipranavir SEDDS, ages 6-11
1254322|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
1254323|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
1254324|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
1254325|NCT00076999|O5|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
1254326|NCT00076999|O4|Outcome|TPV SEDDS 6-<12 Yrs|Patients treated with Tipranavir SEDDS, ages 6-11
1254327|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
1254328|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
1254329|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
1254330|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
1254331|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
1254332|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
1254333|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
1254334|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
1254335|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
1254336|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
1254337|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
1254338|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
1254339|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
1254340|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
1254341|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
1254342|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
1254343|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
1254360|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
1254361|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
1254362|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
1254363|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
1254364|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
1254375|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
1254376|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
1254377|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
1254378|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
1254379|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
1254380|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
1254381|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
1254382|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
1254383|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
1254384|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
1254385|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
1254386|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
1254387|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
1254388|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
1254389|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
1254390|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
1254391|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
1254392|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
1254393|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
1254394|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
1254395|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
1254396|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
1254397|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
1254398|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
1254399|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
1254400|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
1254401|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
1254402|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
1254403|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
1254404|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
1254405|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
1254406|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
1254407|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
1254408|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
1254409|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
1254410|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
1254411|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
1254412|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
1254413|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
1254414|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
1254415|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
1254416|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
1254417|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
1254418|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
1254419|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
1254420|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
1254421|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
1254422|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
1254423|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
1254424|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
1254425|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
1254426|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
1254427|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
1254428|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
1254429|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
1254430|NCT00076999|E5|Reported Event|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
1254484|NCT00076687|O1|Outcome|Placebo|Placebo
1254431|NCT00076999|E4|Reported Event|TPV SEDDS 6-<12 Yrs|Patients treated with Tipranavir SEDDS, ages 6-11
1254432|NCT00076999|E3|Reported Event|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
1254433|NCT00076999|E2|Reported Event|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
1254434|NCT00076999|E1|Reported Event|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
1254435|NCT00076804|B3|Baseline|Total|Total of all reporting groups
1254436|NCT00076804|B2|Baseline|Self Administration|Self administration of ARVs
1254437|NCT00076804|B1|Baseline|Peer Supporter|Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
1254438|NCT00076804|P2|Participant Flow|Self Administration|Self administration of ARVs
1254439|NCT00076804|P1|Participant Flow|Peer Supporter|Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
1254440|NCT00076804|O2|Outcome|Self Administration|Self administration of ARVs
1254441|NCT00076804|O1|Outcome|Peer Supporter|Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
1254442|NCT00076804|O2|Outcome|Self Administration|Self administration of ARVs
1254443|NCT00076804|O1|Outcome|Peer Supporter|Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
1254444|NCT00076804|O2|Outcome|Self Administration|Self administration of ARVs
1254445|NCT00076804|O1|Outcome|Peer Supporter|Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
1254446|NCT00076804|O2|Outcome|Self Administration|Self administration of ARVs
1254447|NCT00076804|O1|Outcome|Peer Supporter|Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
1254448|NCT00076804|E2|Reported Event|Self Administration|Self administration of ARVs
1254449|NCT00076804|E1|Reported Event|Peer Supporter|Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
1254450|NCT00076752|B1|Baseline|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
1254451|NCT00076752|P1|Participant Flow|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, and diphenhydramine. Stem cell transplant infusion day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous."
1254452|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
1254453|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
1254454|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
1254455|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
1254456|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
1254457|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
1254458|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
1254459|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
1254701|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
1254460|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
1254461|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
1254462|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
1254463|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
1254464|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
1254465|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
1254466|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, and diphenhydramine. Stem cell transplant infusion day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous."
1254467|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, and diphenhydramine. Stem cell transplant infusion day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous."
1254468|NCT00076752|E1|Reported Event|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
1254469|NCT00076687|B4|Baseline|Total|Total of all reporting groups
1254470|NCT00076687|B3|Baseline|Botulinum Toxin Type A 360 U|botulinum toxin Type A 360 U
1254471|NCT00076687|B2|Baseline|Botulinum Toxin Type A 240 U|botulinum toxin Type A 240 U
1254472|NCT00076687|B1|Baseline|Placebo|Placebo
1254473|NCT00076687|P3|Participant Flow|Botulinum Toxin Type A 360 U|botulinum toxin Type A 360 U
1254474|NCT00076687|P2|Participant Flow|Botulinum Toxin Type A 240 U|botulinum toxin Type A 240 U
1254475|NCT00076687|P1|Participant Flow|Placebo|Placebo
1254476|NCT00076687|O3|Outcome|Botulinum Toxin Type A 360 U|botulinum toxin Type A 360 U
1254477|NCT00076687|O2|Outcome|Botulinum Toxin Type A 240 U|botulinum toxin Type A 240 U
1254478|NCT00076687|O1|Outcome|Placebo|Placebo
1254479|NCT00076687|O3|Outcome|Botulinum Toxin Type A 360 U|botulinum toxin Type A 360 U
1254480|NCT00076687|O2|Outcome|Botulinum Toxin Type A 240 U|botulinum toxin Type A 240 U
1254481|NCT00076687|O1|Outcome|Placebo|Placebo
1254482|NCT00076687|O3|Outcome|Botulinum Toxin Type A 360 U|botulinum toxin Type A 360 U
1254483|NCT00076687|O2|Outcome|Botulinum Toxin Type A 240 U|botulinum toxin Type A 240 U
1254485|NCT00076687|O3|Outcome|Botulinum Toxin Type A 360 U|botulinum toxin Type A 360 U
1254486|NCT00076687|O2|Outcome|Botulinum Toxin Type A 240 U|botulinum toxin Type A 240 U
1254487|NCT00076687|O1|Outcome|Placebo|Placebo
1254488|NCT00076687|E3|Reported Event|Botulinum Toxin Type A 360 U|botulinum toxin Type A 360 U
1254489|NCT00076687|E2|Reported Event|Botulinum Toxin Type A 240 U|botulinum toxin Type A 240 U
1254490|NCT00076687|E1|Reported Event|Placebo|Placebo
1254491|NCT00076570|B3|Baseline|Total|Total of all reporting groups
1254492|NCT00076570|B2|Baseline|Tacrolimus Group|Patients treated with tacrolimus monotherapy from 6 months after combination therapy
1254493|NCT00076570|B1|Baseline|Sirolimus Group|Patients treated with sirolimus monotherapy from 6 months after combination therapy
1254494|NCT00076570|P2|Participant Flow|Tacrolimus Group|Patients treated with tacrolimus monotherapy from 6 months after combination therapy
1254495|NCT00076570|P1|Participant Flow|Sirolimus Group|Patients treated with sirolimus monotherapy from 6 months after combination therapy
1254496|NCT00076570|O2|Outcome|Tacrolimus Group|Patients treated with tacrolimus monotherapy from 6 months after combination therapy
1254497|NCT00076570|O1|Outcome|Sirolimus Group|Patients treated with sirolimus monotherapy from 6 months after combination therapy
1254498|NCT00076570|O2|Outcome|Tacrolimus Group|Patients treated with tacrolimus monotherapy from 6 months after combination therapy
1254499|NCT00076570|O1|Outcome|Sirolimus Group|Patients treated with sirolimus monotherapy from 6 months after combination therapy
1254500|NCT00076570|E2|Reported Event|Tacrolimus Group|Patients treated with tacrolimus monotherapy from 6 months after combination therapy
1254501|NCT00076570|E1|Reported Event|Sirolimus Group|Patients treated with sirolimus monotherapy from 6 months after combination therapy
1254502|NCT00076336|B3|Baseline|Total|Total of all reporting groups
1254503|NCT00076336|B2|Baseline|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
1254504|NCT00076336|B1|Baseline|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
1254505|NCT00076336|P2|Participant Flow|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
1254506|NCT00076336|P1|Participant Flow|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
1254507|NCT00076336|O2|Outcome|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
1254508|NCT00076336|O1|Outcome|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
1254509|NCT00076336|O2|Outcome|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
1254510|NCT00076336|O1|Outcome|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
1254511|NCT00076336|O2|Outcome|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
1254512|NCT00076336|O1|Outcome|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
1254513|NCT00076336|O2|Outcome|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
1254514|NCT00076336|O1|Outcome|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
1254515|NCT00076336|O2|Outcome|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
1254516|NCT00076336|O1|Outcome|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
1254517|NCT00076336|E2|Reported Event|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
1254518|NCT00076336|E1|Reported Event|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
1254519|NCT00076258|B3|Baseline|Total|Total of all reporting groups
1254520|NCT00076258|B2|Baseline|SSRI+ PHD|"A public health dose of aerobic exercise (PHD) augmentation intervention to SSRI~SSRI + PHD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
1254521|NCT00076258|B1|Baseline|SSRI+ LD|"A low dose aerobic exercise (LD) augmentation intervention to SSRI~SSRI + LD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
1254542|NCT00076245|O3|Outcome|3 Light Therapy Plus Cognitive Behavioral Therapy|"Light Therapy: Light therapy will involve exposure to bright light twice a day.~Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week."
1254543|NCT00076245|O2|Outcome|2 Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
1254544|NCT00076245|O1|Outcome|1 Light Therapy|Light Therapy: Light therapy will involve exposure to bright light twice a day.
1254522|NCT00076258|P2|Participant Flow|SSRI+ PHD|"A public health dose of aerobic exercise (PHD) augmentation intervention to SSRI~SSRI + PHD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
1254523|NCT00076258|P1|Participant Flow|SSRI+ LD|"A low dose aerobic exercise (LD) augmentation intervention to SSRI~SSRI + LD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
1254524|NCT00076258|O2|Outcome|SSRI+ PHD|"A public health dose of aerobic exercise (PHD) augmentation intervention to SSRI~SSRI + PHD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
1254525|NCT00076258|O1|Outcome|SSRI+ LD|"A low dose aerobic exercise (LD) augmentation intervention to SSRI~SSRI + LD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
1254526|NCT00076258|E2|Reported Event|SSRI+ PHD|"A public health dose of aerobic exercise (PHD) augmentation intervention to SSRI~SSRI + PHD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
1254527|NCT00076258|E1|Reported Event|SSRI+ LD|"A low dose aerobic exercise (LD) augmentation intervention to SSRI~SSRI + LD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
1254528|NCT00076245|B5|Baseline|Total|Total of all reporting groups
1254529|NCT00076245|B4|Baseline|4 Control|
1254530|NCT00076245|B3|Baseline|3 Light Therapy Plus Cognitive Behavioral Therapy|"Light Therapy: Light therapy will involve exposure to bright light twice a day.~Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week."
1254531|NCT00076245|B2|Baseline|2 Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
1254532|NCT00076245|B1|Baseline|1 Light Therapy|Light Therapy: Light therapy will involve exposure to bright light twice a day.
1254533|NCT00076245|P4|Participant Flow|4 Control|
1254534|NCT00076245|P3|Participant Flow|3 Light Therapy Plus Cognitive Behavioral Therapy|"Light Therapy: Light therapy will involve exposure to bright light twice a day.~Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week."
1254535|NCT00076245|P2|Participant Flow|2 Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
1254536|NCT00076245|P1|Participant Flow|1 Light Therapy|Light Therapy: Light therapy will involve exposure to bright light twice a day.
1254537|NCT00076245|O4|Outcome|4 Control|
1254572|NCT00076050|O2|Outcome|Placebo Group|A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
1254538|NCT00076245|O3|Outcome|3 Light Therapy Plus Cognitive Behavioral Therapy|"Light Therapy: Light therapy will involve exposure to bright light twice a day.~Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week."
1254539|NCT00076245|O2|Outcome|2 Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
1254540|NCT00076245|O1|Outcome|1 Light Therapy|Light Therapy: Light therapy will involve exposure to bright light twice a day.
1254541|NCT00076245|O4|Outcome|4 Control|
1254545|NCT00076245|E4|Reported Event|4 Control|
1255856|NCT00070499|E3|Reported Event|Dasatinib|Patients received 100 mg dasatinib daily
1254546|NCT00076245|E3|Reported Event|3 Light Therapy Plus Cognitive Behavioral Therapy|"Light Therapy: Light therapy will involve exposure to bright light twice a day.~Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week."
1254547|NCT00076245|E2|Reported Event|2 Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
1254548|NCT00076245|E1|Reported Event|1 Light Therapy|Light Therapy: Light therapy will involve exposure to bright light twice a day.
1254549|NCT00076219|B3|Baseline|Total|Total of all reporting groups
1254550|NCT00076219|B2|Baseline|Less-intensive Renal Replacement Therapy|In the less-intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 3 times per week, and continuous venovenous hemodiafiltration was provided at 20 mL/kg/hour.
1254551|NCT00076219|B1|Baseline|Intensive Renal Replacement Therapy|In the intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 6 times per week, and continuous venovenous hemodiafiltration was provided at 35 mL/kg/hour.
1254552|NCT00076219|P2|Participant Flow|Less-intensive Renal Replacement Therapy|In the less-intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 3 times per week, and continuous venovenous hemodiafiltration was provided at 20 mL/kg/hour.
1254553|NCT00076219|P1|Participant Flow|Intensive Renal Replacement Therapy|In the intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 6 times per week, and continuous venovenous hemodiafiltration was provided at 35 mL/kg/hour.
1254554|NCT00076219|O2|Outcome|Less-intensive Renal Replacement Therapy|In the less-intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 3 times per week, and continuous venovenous hemodiafiltration was provided at 20 mL/kg/hour.
1254555|NCT00076219|O1|Outcome|Intensive Renal Replacement Therapy|In the intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 6 times per week, and continuous venovenous hemodiafiltration was provided at 35 mL/kg/hour.
1254556|NCT00076219|E2|Reported Event|Less-intensive Renal Replacement Therapy|In the less-intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 3 times per week, and continuous venovenous hemodiafiltration was provided at 20 mL/kg/hour.
1254557|NCT00076219|E1|Reported Event|Intensive Renal Replacement Therapy|In the intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 6 times per week, and continuous venovenous hemodiafiltration was provided at 35 mL/kg/hour.
1254558|NCT00076102|B1|Baseline|Pirfenidone|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m2/day).
1254559|NCT00076102|P1|Participant Flow|Pirfenidone|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m2/day).
1254560|NCT00076102|O1|Outcome|Pirfenidine|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m2/day).
1254561|NCT00076102|O1|Outcome|Pirfenidone|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m2/day).
1254562|NCT00076102|E1|Reported Event|Pirfenidone|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m2/day).
1254563|NCT00076050|B3|Baseline|Total|Total of all reporting groups
1254564|NCT00076050|B2|Baseline|Placebo Group|A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
1254565|NCT00076050|B1|Baseline|Soy Isoflavone Group|A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.
1254566|NCT00076050|P2|Participant Flow|Placebo Group|A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
1254567|NCT00076050|P1|Participant Flow|Soy Isoflavone Group|A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.
1254568|NCT00076050|O2|Outcome|Placebo Group|A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
1254569|NCT00076050|O1|Outcome|Soy Isoflavone Group|A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.
1254570|NCT00076050|O2|Outcome|Placebo Group|A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
1254571|NCT00076050|O1|Outcome|Soy Isoflavone Group|A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.
1254573|NCT00076050|O1|Outcome|Soy Isoflavone Group|A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.
1254574|NCT00076050|E2|Reported Event|Placebo|A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
1254700|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
1254575|NCT00076050|E1|Reported Event|Soy Isoflavones|A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.
1254576|NCT00076024|B4|Baseline|Total|Total of all reporting groups
1254577|NCT00076024|B3|Baseline|Docetaxel + Placebo (Double-blind)|Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued with axitinib (AG-013736) 5 mg tablet orally BID continuously in cycles of 4 weeks.
1254578|NCT00076024|B2|Baseline|Axitinib + Docetaxel (Phase 2, Double-blind)|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.
1254579|NCT00076024|B1|Baseline|Axitinib + Docetaxel (Phase 1, Lead-in)|Axitinib (AG-013736) 5 mg tablet orally twice daily BID starting from Day 3 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks.
1254580|NCT00076024|P4|Participant Flow|Axitinib (Phase 2, Open-label)|Axitinib (AG-013736) 5 mg tablet orally BID continuously in cycles of 4 weeks.
1254581|NCT00076024|P3|Participant Flow|Docetaxel + Placebo (Phase 2, Double-blind)|Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued to open-label phase.
1254582|NCT00076024|P2|Participant Flow|Axitinib + Docetaxel (Phase 2, Double-blind)|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.
1254583|NCT00076024|P1|Participant Flow|Axitinib + Docetaxel (Phase-1, Lead-in)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 milligram/square meter (mg/m^2) 1 hour (hr) intravenous (IV) infusion on Day 1 of each cycle, in cycles of 3 weeks.
1254584|NCT00076024|O1|Outcome|Axitinib (Phase 2, Open-label)|Axitinib (AG-013736) 5 mg tablet orally BID continuously in cycles of 4 weeks.
1254585|NCT00076024|O2|Outcome|Docetaxel + Placebo (Phase 2, Double-blind)|Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued to open-label phase.
1254586|NCT00076024|O1|Outcome|Axitinib + Docetaxel (Phase 2, Double-blind)|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.
1254587|NCT00076024|O1|Outcome|Axitinib (Phase 2, Open-label)|Axitinib (AG-013736) 5 mg tablet orally BID continuously in cycles of 4 weeks.
1254588|NCT00076024|O2|Outcome|Docetaxel + Placebo (Phase 2, Double-blind)|Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued to open-label phase.
1254589|NCT00076024|O1|Outcome|Axitinib + Docetaxel (Phase 2, Double-blind)|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.
1254590|NCT00076024|O2|Outcome|Docetaxel + Placebo (Phase 2, Double-blind)|Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued to open-label phase.
1254591|NCT00076024|O1|Outcome|Axitinib + Docetaxel (Phase 2, Double-blind)|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.
1254592|NCT00076024|E4|Reported Event|Axitinib (Phase 2, Open-label)|Axitinib (AG-013736) 5 mg tablet orally BID continuously in cycles of 4 weeks.
1254593|NCT00076024|E3|Reported Event|Docetaxel + Placebo (Phase 2, Double-blind)|Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued to open-label phase.
1254594|NCT00076024|E2|Reported Event|Axitinib + Docetaxel (Phase 2, Double-blind)|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.
1254694|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
1254595|NCT00076024|E1|Reported Event|Axitinib + Docetaxel (Phase-1 Lead-in)|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 3 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks.
1254596|NCT00076011|B1|Baseline|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
1254597|NCT00076011|P1|Participant Flow|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
1254598|NCT00076011|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
1254599|NCT00076011|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
1254600|NCT00076011|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
1254601|NCT00076011|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
1254602|NCT00076011|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
1254603|NCT00076011|E1|Reported Event|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
1254604|NCT00075946|B5|Baseline|Total|Total of all reporting groups
1254605|NCT00075946|B4|Baseline|Rituximab Scheduled: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
1254606|NCT00075946|B3|Baseline|Rituximab Retreatment: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
1254607|NCT00075946|B2|Baseline|Rituximab Scheduled: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
1254608|NCT00075946|B1|Baseline|Rituximab Retreatment: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
1254609|NCT00075946|P5|Participant Flow|Enrolled But Not Randomized|Patients who were enrolled in the study but not proceed to randomization. These could include patients with undetermined histology as well as those who did not achieve response (PR or CR) after induction rituximab.
1254610|NCT00075946|P4|Participant Flow|Rituximab Scheduled: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
1254611|NCT00075946|P3|Participant Flow|Rituximab Retreatment: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
1254612|NCT00075946|P2|Participant Flow|Rituximab Scheduled: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
1254613|NCT00075946|P1|Participant Flow|Rituximab Retreatment: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
1254614|NCT00075946|O2|Outcome|Arm B: Rituximab Scheduled|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity.
1254615|NCT00075946|O1|Outcome|Arm A: Rituximab Retreatment|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months.
1254616|NCT00075946|O4|Outcome|Rituximab Scheduled: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
1254617|NCT00075946|O3|Outcome|Rituximab Retreatment: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
1254618|NCT00075946|O2|Outcome|Rituximab Scheduled: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
1254644|NCT00075829|O1|Outcome|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
1254645|NCT00075829|O4|Outcome|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
1254619|NCT00075946|O1|Outcome|Rituximab Retreatment: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
1254620|NCT00075946|O4|Outcome|Rituximab Scheduled: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
1254621|NCT00075946|O3|Outcome|Rituximab Retreatment: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
1254622|NCT00075946|O2|Outcome|Rituximab Scheduled: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
1254623|NCT00075946|O1|Outcome|Rituximab Retreatment: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
1254624|NCT00075946|E3|Reported Event|Arm B: Rituximab Scheduled|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity.
1254625|NCT00075946|E2|Reported Event|Arm A: Rituximab Retreatment|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months.
1254626|NCT00075946|E1|Reported Event|Arm I: Induction Rituximab|Patients received rituximab IV once a week for 4 weeks. Patients were re-evaluated 9 weeks after the completion of induction rituximab. Patients with a partial or complete response to induction rituximab were randomized to one of the two treatment arms.
1254627|NCT00075881|B1|Baseline|PS-341|"Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.~Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15.~Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose."
1254628|NCT00075881|P1|Participant Flow|PS-341|"Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.~Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15.~Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose."
1254629|NCT00075881|O1|Outcome|PS-341|"Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.~Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15~Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose."
1254630|NCT00075881|O1|Outcome|PS-341|Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose
1254631|NCT00075881|O1|Outcome|PS-341|Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15
1254632|NCT00075881|O1|Outcome|PS-341|"Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.~Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15~Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose."
1254633|NCT00075881|E1|Reported Event|PS-341|"Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.~Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15.~Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose."
1254634|NCT00075829|B5|Baseline|Total|Total of all reporting groups
1254635|NCT00075829|B4|Baseline|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
1254636|NCT00075829|B3|Baseline|Auto-Auto High Risk|"Tandem autologous transplant plus thalidomide/dexamethasone (Thal-Dex) or observation (Obs) for high risk patients~PFS and OS did not differ between the Thal-Dex and the Obs arms and were thus pooled for analysis."
1254637|NCT00075829|B2|Baseline|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
1254638|NCT00075829|B1|Baseline|Auto-Auto Standard Risk|"Tandem autologous transplant plus thalidomide/dexamethasone (Thal-Dex) or observation (Obs) for standard risk patients~PFS and OS did not differ between the Thal-Dex and the Obs arms and were thus pooled for analysis."
1254639|NCT00075829|P4|Participant Flow|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
1254640|NCT00075829|P3|Participant Flow|Auto-Auto High Risk|"Tandem autologous transplant plus thalidomide/dexamethasone (Thal-Dex) or observation (Obs) for high risk patients~PFS and OS did not differ between the Thal-Dex and the Obs arms and were thus pooled for analysis."
1254641|NCT00075829|P2|Participant Flow|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
1254642|NCT00075829|P1|Participant Flow|Auto-Auto Standard Risk|Tandem autologous transplant plus thalidomide/dexamethasone (Thal-Dex) or observation (Obs) for standard risk patients PFS and OS did not differ between the Thal-Dex and the Obs arms and were thus pooled for analysis.
1254643|NCT00075829|O1|Outcome|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
1254695|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
1254646|NCT00075829|O3|Outcome|Auto-Auto High Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for high risk patients
1254647|NCT00075829|O2|Outcome|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
1254648|NCT00075829|O1|Outcome|Auto-Auto Standard Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for standard risk patients
1254649|NCT00075829|O4|Outcome|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
1254650|NCT00075829|O3|Outcome|Auto-Auto High Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for high risk patients
1254651|NCT00075829|O2|Outcome|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
1254652|NCT00075829|O1|Outcome|Auto-Auto Standard Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for standard risk patients
1254653|NCT00075829|O4|Outcome|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
1254654|NCT00075829|O3|Outcome|Auto-Auto High Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for high risk patients
1254655|NCT00075829|O2|Outcome|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
1254656|NCT00075829|O1|Outcome|Auto-Auto Standard Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for standard risk patients
1254657|NCT00075829|O2|Outcome|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
1254658|NCT00075829|O1|Outcome|Auto-Auto High Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for high risk patients
1254659|NCT00075829|O2|Outcome|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
1254660|NCT00075829|O1|Outcome|Auto-Auto Standard Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for standard risk patients
1254661|NCT00075829|O4|Outcome|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
1254662|NCT00075829|O3|Outcome|Auto-Auto High Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for high risk patients
1254663|NCT00075829|O2|Outcome|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
1254664|NCT00075829|O1|Outcome|Auto-Auto Standard Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for standard risk patients
1254665|NCT00075829|E4|Reported Event|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
1254666|NCT00075829|E3|Reported Event|Auto-Auto High Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for high risk patients
1254667|NCT00075829|E2|Reported Event|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
1254668|NCT00075829|E1|Reported Event|Auto-Auto Standard Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for standard risk patients
1254669|NCT00075816|B3|Baseline|Total|Total of all reporting groups
1254670|NCT00075816|B2|Baseline|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
1254671|NCT00075816|B1|Baseline|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
1254672|NCT00075816|P2|Participant Flow|Peripheral-Blood Stem Cells|Patients who underwent transplantation of peripheral-blood stem cells from unrelated donors; all randomized patients were included in the primary, intention-to-treat analysis.
1254673|NCT00075816|P1|Participant Flow|Bone Marrow|Patients who underwent transplantation of bone marrow from unrelated donors; all randomized patients were included in the primary, intention-to-treat analysis.
1254674|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Patients who received transplantation of peripheral-blood stem cells from unrelated donors.
1254675|NCT00075816|O1|Outcome|Bone Marrow|Patients who received transplantation of bone marrow from unrelated donors.
1254676|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
1254677|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
1254678|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
1254679|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
1254680|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
1254681|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
1254682|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Patients who received transplantation of peripheral-blood stem cells from unrelated donors.
1254683|NCT00075816|O1|Outcome|Bone Marrow|Patients who received transplantation of bone marrow from unrelated donors.
1254684|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Patients who received transplantation of peripheral-blood stem cells from unrelated donors.
1254685|NCT00075816|O1|Outcome|Bone Marrow|Patients who received transplantation of bone marrow from unrelated donors.
1254686|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
1254687|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
1254688|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
1254689|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
1254690|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
1254691|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
1254692|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
1254693|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
1254696|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
1254697|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
1254698|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Patients who received transplantation of peripheral-blood stem cells from unrelated donors.
1254699|NCT00075816|O1|Outcome|Bone Marrow|Patients who received transplantation of bone marrow from unrelated donors.
1254702|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
1254703|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
1254704|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
1254705|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
1254706|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
1254707|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
1254708|NCT00075816|E2|Reported Event|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
1254709|NCT00075816|E1|Reported Event|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
1254710|NCT00075803|B3|Baseline|Total|Total of all reporting groups
1254711|NCT00075803|B2|Baseline|Voriconazole|voriconazole prophylaxis
1254712|NCT00075803|B1|Baseline|Fluconazole|fluconazole prophylaxis
1254713|NCT00075803|P2|Participant Flow|Voriconazole|voriconazole prophylaxis
1254714|NCT00075803|P1|Participant Flow|Fluconazole|fluconazole prophylaxis
1254715|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
1254716|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
1254717|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
1254718|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
1254719|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
1254720|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
1254721|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
1254722|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
1254723|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
1254724|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
1254725|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
1254726|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
1254727|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
1254728|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
1254729|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
1254730|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
1254731|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
1254732|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
1254733|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
1254734|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
1254735|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
1254736|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
1254737|NCT00075803|E2|Reported Event|Voriconazole|voriconazole prophylaxis
1254738|NCT00075803|E1|Reported Event|Fluconazole|fluconazole prophylaxis
1254739|NCT00075764|B3|Baseline|Total|Total of all reporting groups
1254740|NCT00075764|B2|Baseline|Arm II Anastrozole and Fulvestrant|"Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.~anastrozole: Given orally~fulvestrant: Given intramuscularly"
1254741|NCT00075764|B1|Baseline|Arm I Anastrozole|"Patients receive oral anastrozole once daily on days 1-28.~anastrozole: Given orally"
1254742|NCT00075764|P2|Participant Flow|Arm II Anastrozole and Fulvestrant|"Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.~anastrozole: Given orally~fulvestrant: Given intramuscularly"
1254743|NCT00075764|P1|Participant Flow|Arm I Anastrozole|"Patients receive oral anastrozole once daily on days 1-28.~anastrozole: Given orally"
1254744|NCT00075764|O2|Outcome|Arm II Anastrozole and Fulvestrant|Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1 , 14, and 28 during course 1 and then on day 28 of the subsequent courses.
1254745|NCT00075764|O1|Outcome|Arm I Anastrozole|Patients receive oral anastrozole once daily on days 1-28
1254746|NCT00075764|O2|Outcome|Arm II Anastrozole and Fulvestrant|"Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.~anastrozole: Given orally~fulvestrant: Given intramuscularly"
1254747|NCT00075764|O1|Outcome|Arm I Anastrozole|"Patients receive oral anastrozole once daily on days 1-28.~anastrozole: Given orally"
1254748|NCT00075764|O2|Outcome|Arm II Anastrozole and Fulvestrant|"Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.~anastrozole: Given orally~fulvestrant: Given intramuscularly"
1254749|NCT00075764|O1|Outcome|Arm I Anastrozole|"Patients receive oral anastrozole once daily on days 1-28.~anastrozole: Given orally"
1254750|NCT00075764|O2|Outcome|Arm II Anastrozole and Fulvestrant|"Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.~anastrozole: Given orally~fulvestrant: Given intramuscularly"
1254751|NCT00075764|O1|Outcome|Arm I Anastrozole|"Patients receive oral anastrozole once daily on days 1-28.~anastrozole: Given orally"
1254752|NCT00075764|E2|Reported Event|Anastrozole & Fulvestrant|Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1 , 14, and 28 during course 1 and then on day 28 of the subsequent courses.
1254753|NCT00075764|E1|Reported Event|Anastrozole|Patients receive oral anastrozole once daily on days 1-28
1254932|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1255488|NCT00071812|B4|Baseline|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1254755|NCT00075725|B12|Baseline|Prednisone and High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the PH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth
1254756|NCT00075725|B11|Baseline|Dexamethasone, Capizzi Methotrexate Down Syndrome|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254757|NCT00075725|B10|Baseline|Prednisone, Capezzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254758|NCT00075725|B9|Baseline|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254759|NCT00075725|B8|Baseline|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254760|NCT00075725|B7|Baseline|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254761|NCT00075725|B6|Baseline|Prednisone, Capezzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254762|NCT00075725|B5|Baseline|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254942|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1255053|NCT00074958|O1|Outcome|Fabrazyme|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks.
1255054|NCT00074958|O1|Outcome|Fabrazyme|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks.
1254763|NCT00075725|B4|Baseline|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1255091|NCT00074711|B2|Baseline|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
1254764|NCT00075725|B3|Baseline|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254765|NCT00075725|B2|Baseline|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254766|NCT00075725|B1|Baseline|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254767|NCT00075725|P12|Participant Flow|Prednisone and High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the PH regimen based on one (or more) of the following: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal MTX in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254768|NCT00075725|P11|Participant Flow|Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254769|NCT00075725|P10|Participant Flow|Prednisone, Capezzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254770|NCT00075725|P9|Participant Flow|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254780|NCT00075725|O10|Outcome|Prednisone, Capezzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254771|NCT00075725|P8|Participant Flow|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254772|NCT00075725|P7|Participant Flow|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH (Prednisone, High Dose MTX) regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254773|NCT00075725|P6|Participant Flow|Prednisone, Capezzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254774|NCT00075725|P5|Participant Flow|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC (Prednisone, Capizzi) will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254775|NCT00075725|P4|Participant Flow|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254776|NCT00075725|P3|Participant Flow|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254777|NCT00075725|P2|Participant Flow|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH (High Dose) regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254778|NCT00075725|P1|Participant Flow|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254779|NCT00075725|O11|Outcome|Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254943|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254781|NCT00075725|O9|Outcome|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254933|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1255092|NCT00074711|B1|Baseline|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
1254782|NCT00075725|O8|Outcome|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254783|NCT00075725|O7|Outcome|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254784|NCT00075725|O6|Outcome|Prednisone, Capezzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254785|NCT00075725|O5|Outcome|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254786|NCT00075725|O4|Outcome|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254787|NCT00075725|O3|Outcome|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254788|NCT00075725|O2|Outcome|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254944|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254789|NCT00075725|O1|Outcome|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254790|NCT00075725|O9|Outcome|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1255093|NCT00074711|P2|Participant Flow|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
1254791|NCT00075725|O8|Outcome|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254792|NCT00075725|O7|Outcome|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254793|NCT00075725|O6|Outcome|Prednisone, Capizzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254794|NCT00075725|O5|Outcome|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254795|NCT00075725|O4|Outcome|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254796|NCT00075725|O3|Outcome|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254797|NCT00075725|O2|Outcome|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254798|NCT00075725|O1|Outcome|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254799|NCT00075725|O12|Outcome|Prednisone and High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the PH regimen based on one (or more) of the following: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal MTX in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1255315|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
1254800|NCT00075725|O11|Outcome|Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254801|NCT00075725|O10|Outcome|Prednisone, Capezzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254802|NCT00075725|O9|Outcome|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254803|NCT00075725|O8|Outcome|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254804|NCT00075725|O7|Outcome|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254805|NCT00075725|O6|Outcome|Prednisone, Capezzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254806|NCT00075725|O5|Outcome|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1255055|NCT00074958|E1|Reported Event|Fabrazyme|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks.
1255056|NCT00074815|B4|Baseline|Total|Total of all reporting groups
1254807|NCT00075725|O4|Outcome|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254808|NCT00075725|O3|Outcome|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254934|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1255316|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
1254809|NCT00075725|O2|Outcome|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254810|NCT00075725|O1|Outcome|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254811|NCT00075725|O12|Outcome|Prednisone and High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the PH regimen based on one (or more) of the following: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal MTX in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254812|NCT00075725|O11|Outcome|Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254813|NCT00075725|O10|Outcome|Prednisone, Capezzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254814|NCT00075725|O9|Outcome|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254945|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254815|NCT00075725|O8|Outcome|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254816|NCT00075725|O7|Outcome|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254817|NCT00075725|O6|Outcome|Prednisone, Capezzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1255317|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
1254818|NCT00075725|O5|Outcome|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254819|NCT00075725|O4|Outcome|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254820|NCT00075725|O3|Outcome|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254821|NCT00075725|O2|Outcome|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254822|NCT00075725|O1|Outcome|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254823|NCT00075725|O11|Outcome|Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1255057|NCT00074815|B3|Baseline|MM Only|Participants will receive medication management only
1255058|NCT00074815|B2|Baseline|MM + ICBT|Participants will receive medication management plus instructional cognitive behavioral therapy with a psychiatrist
1254824|NCT00075725|O10|Outcome|Prednisone, Capizzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254825|NCT00075725|O9|Outcome|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254826|NCT00075725|O8|Outcome|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254935|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1255857|NCT00070499|E2|Reported Event|High Dose Imatinib|Patients received 800 mg imatinib daily
1254827|NCT00075725|O7|Outcome|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254828|NCT00075725|O6|Outcome|Prednisone, Capizzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254829|NCT00075725|O5|Outcome|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254830|NCT00075725|O4|Outcome|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254831|NCT00075725|O3|Outcome|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254849|NCT00075725|O5|Outcome|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1255363|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
1254832|NCT00075725|O2|Outcome|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254833|NCT00075725|O1|Outcome|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254834|NCT00075725|O9|Outcome|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254835|NCT00075725|O8|Outcome|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1255016|NCT00075088|O2|Outcome|Routine Clinical Practice|Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
1255528|NCT00071812|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1254836|NCT00075725|O7|Outcome|Predisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254837|NCT00075725|O6|Outcome|Prednisone, Capizzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254838|NCT00075725|O5|Outcome|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254839|NCT00075725|O4|Outcome|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254840|NCT00075725|O3|Outcome|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254841|NCT00075725|O2|Outcome|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254842|NCT00075725|O1|Outcome|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254843|NCT00075725|O11|Outcome|Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254844|NCT00075725|O10|Outcome|Prenisone, Capezzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254863|NCT00075725|E3|Reported Event|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254845|NCT00075725|O9|Outcome|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254846|NCT00075725|O8|Outcome|Prenisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254847|NCT00075725|O7|Outcome|Predisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254848|NCT00075725|O6|Outcome|Prednisone, Capezzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254946|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1255059|NCT00074815|B1|Baseline|MM + CBT|Participants will receive medication management plus cognitive behavioral therapy with a psychologist
1254850|NCT00075725|O4|Outcome|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254851|NCT00075725|O3|Outcome|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254852|NCT00075725|O2|Outcome|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254853|NCT00075725|O1|Outcome|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1255017|NCT00075088|O1|Outcome|Electrocardiogram (ECG) Intervention|Patients randomized to the experimental group had their ECGs printed out in the target ED with an audible voice alarm. Print-out of the pre-hospital ECG in the target ED was the intervention.
1254854|NCT00075725|E12|Reported Event|Prednisone and High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the PH regimen based on one (or more) of the following: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal MTX in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254855|NCT00075725|E11|Reported Event|Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254856|NCT00075725|E10|Reported Event|Prednisone, Capezzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254857|NCT00075725|E9|Reported Event|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254947|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1255060|NCT00074815|P3|Participant Flow|MM Only|Participants will receive medication management only
1255061|NCT00074815|P2|Participant Flow|MM + ICBT|Participants will receive medication management plus instructional cognitive behavioral therapy with a psychiatrist
1254858|NCT00075725|E8|Reported Event|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254859|NCT00075725|E7|Reported Event|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254860|NCT00075725|E6|Reported Event|Prednisone, Capezzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254861|NCT00075725|E5|Reported Event|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
1254862|NCT00075725|E4|Reported Event|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1255018|NCT00075088|O2|Outcome|Routine Clinical Practice|Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
1254864|NCT00075725|E2|Reported Event|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254865|NCT00075725|E1|Reported Event|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
1254866|NCT00075608|B1|Baseline|Second Transplant|Participants underwent a second treatment with high dose chemotherapy and stem cell transplant
1254867|NCT00075608|P1|Participant Flow|Second Transplant|Participants underwent a second treatment with high dose chemotherapy and stem cell transplant
1254868|NCT00075608|O1|Outcome|2nd SCT|"Mobilization with filgrastim Second autologous peripheral blood stem cell transplant with melphalan conditioning~filgrastim: 16mcg/kg IV daily beginning three days prior to SCC through last day of SCC~melphalan: 140-200 mcg/kg IV over two days~autologous bone marrow transplantation: infusion of previously collected stem cells on Day 0~peripheral blood stem cell transplantation: infusion of previously collected stem cells on Day 0"
1254869|NCT00075608|O1|Outcome|2nd SCT|"Mobilization with filgrastim Second autologous peripheral blood stem cell transplant with melphalan conditioning~filgrastim: 16mcg/kg IV daily beginning three days prior to stem cell collection through last day of SCC~melphalan: 140-200 mcg/kg IV over two days~autologous bone marrow transplantation: infusion of previously collected stem cells on Day 0~peripheral blood stem cell transplantation: infusion of previously collected stem cells on Day 0"
1254870|NCT00075608|O1|Outcome|Second Transplant|Participants underwent a second treatment with high dose chemotherapy and stem cell transplant
1254871|NCT00075608|E1|Reported Event|Second Transplant|Participants who received a second transplant
1254872|NCT00075582|B3|Baseline|Total|Total of all reporting groups
1254873|NCT00075582|B2|Baseline|Regimen II (Chemotherapy, Radiotherapy, Surgery)|"Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).~conventional surgery: Some patients may undergo second-look surgery~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
1254874|NCT00075582|B1|Baseline|Regimen I (Chemotherapy, Radiotherapy)|"Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
1254875|NCT00075582|P2|Participant Flow|Regimen II (Chemotherapy, Radiotherapy, Surgery)|"Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).~conventional surgery: Some patients may undergo second-look surgery~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
1254876|NCT00075582|P1|Participant Flow|Regimen I (Chemotherapy, Radiotherapy)|"Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
1254877|NCT00075582|O1|Outcome|Regimen II (Chemotherapy, Radiotherapy, Surgery)|"Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).~conventional surgery: Some patients may undergo second-look surgery~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
1255019|NCT00075088|O1|Outcome|Electrocardiogram (ECG) Intervention|Patients randomized to the experimental group had their ECGs printed out in the target ED with an audible voice alarm. Print-out of the pre-hospital ECG in the target ED was the intervention.
1254878|NCT00075582|O1|Outcome|Regimen I (Chemotherapy, Radiotherapy)|"Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
1254879|NCT00075582|O2|Outcome|Regimen II (Chemotherapy, Radiotherapy, Surgery)|"Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).~conventional surgery: Some patients may undergo second-look surgery~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
1254880|NCT00075582|O1|Outcome|Regimen I (Chemotherapy, Radiotherapy)|"Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
1254881|NCT00075582|E2|Reported Event|Regimen II (Chemotherapy, Radiotherapy, Surgery)|"Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).~conventional surgery: Some patients may undergo second-look surgery~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
1255134|NCT00074412|O1|Outcome|Nevirapine|For infants: extended treatment with NVP
1254882|NCT00075582|E1|Reported Event|Regimen I (Chemotherapy, Radiotherapy)|"Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
1254883|NCT00075504|B3|Baseline|Total|Total of all reporting groups
1254884|NCT00075504|B2|Baseline|Stratum B Abnormal Liver Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
1254885|NCT00075504|B1|Baseline|Stratum A Normal Liver Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
1254886|NCT00075504|P2|Participant Flow|Stratum B Abnormal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
1254887|NCT00075504|P1|Participant Flow|Stratum A Normal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
1254888|NCT00075504|O2|Outcome|Stratum B Abnormal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
1254889|NCT00075504|O1|Outcome|Stratum A Normal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
1254890|NCT00075504|O2|Outcome|Stratum B Abnormal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
1254891|NCT00075504|O1|Outcome|Stratum A Normal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
1254892|NCT00075504|O2|Outcome|Stratum B Abnormal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
1254893|NCT00075504|O1|Outcome|Stratum A Normal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
1254894|NCT00075504|E2|Reported Event|Stratum B Abnormal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
1254895|NCT00075504|E1|Reported Event|Stratum A Normal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
1254896|NCT00075478|B3|Baseline|Total|Total of all reporting groups
1254931|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254897|NCT00075478|B2|Baseline|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
1254898|NCT00075478|B1|Baseline|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
1254899|NCT00075478|P2|Participant Flow|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
1254948|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254949|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254900|NCT00075478|P1|Participant Flow|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
1254901|NCT00075478|O2|Outcome|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
1254902|NCT00075478|O1|Outcome|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
1254903|NCT00075478|O2|Outcome|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
1254904|NCT00075478|O1|Outcome|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
1254905|NCT00075478|O2|Outcome|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
1255870|NCT00070109|B6|Baseline|Total|Total of all reporting groups
1254906|NCT00075478|O1|Outcome|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
1254907|NCT00075478|O2|Outcome|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
1254917|NCT00075478|E2|Reported Event|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
1254908|NCT00075478|O1|Outcome|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
1254909|NCT00075478|O2|Outcome|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
1254910|NCT00075478|O1|Outcome|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
1254911|NCT00075478|O2|Outcome|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
1254912|NCT00075478|O1|Outcome|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
1254913|NCT00075478|O2|Outcome|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
1254914|NCT00075478|O1|Outcome|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
1254915|NCT00075478|O2|Outcome|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
1254916|NCT00075478|O1|Outcome|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
1254918|NCT00075478|E1|Reported Event|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
1254919|NCT00075400|B1|Baseline|Gleevec|Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
1254920|NCT00075400|P1|Participant Flow|Gleevec|Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
1254921|NCT00075400|O1|Outcome|Gleevec|Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
1254922|NCT00075400|O1|Outcome|Gleevec|Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
1254923|NCT00075400|O1|Outcome|Gleevec|Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
1254924|NCT00075400|E1|Reported Event|Gleevec|Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
1254925|NCT00075270|B3|Baseline|Total|Total of all reporting groups
1254926|NCT00075270|B2|Baseline|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254927|NCT00075270|B1|Baseline|Lapatinib With Paclitaxel|Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254928|NCT00075270|P2|Participant Flow|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254929|NCT00075270|P1|Participant Flow|Lapatinib With Paclitaxel|Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254930|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1255489|NCT00071812|B3|Baseline|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1254936|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254937|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254938|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254939|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254940|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254941|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1255050|NCT00074984|E1|Reported Event|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme(agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
1254950|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254951|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254952|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254953|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254954|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254955|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1255318|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
1254956|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254957|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254958|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254959|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254960|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254961|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254962|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254963|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254964|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254965|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254966|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254967|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254968|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1255051|NCT00074958|B1|Baseline|Fabrazyme|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks.
1255052|NCT00074958|P1|Participant Flow|Fabrazyme|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks.
1254969|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254970|NCT00075270|E2|Reported Event|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254971|NCT00075270|E1|Reported Event|Lapatinib With Paclitaxel|Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
1254972|NCT00075218|B3|Baseline|Total|Total of all reporting groups
1254973|NCT00075218|B2|Baseline|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
1254974|NCT00075218|B1|Baseline|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
1254975|NCT00075218|P3|Participant Flow|Sunitinib Open-Label Treatment|Subjects experiencing disease progression could have their treatment assignment unblinded, and subjects who had been receiving placebo could crossover to open-label treatment with sunitinib; subjects who had been receiving sunitinib during double-blind treatment of the study could continue to do so after unblinding if, in the opinion of the investigator, there was sufficient evidence of clinical benefit.
1255373|NCT00072761|B3|Baseline|Total|Total of all reporting groups
1254976|NCT00075218|P2|Participant Flow|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
1254977|NCT00075218|P1|Participant Flow|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
1254978|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
1254979|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
1254980|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
1254981|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
1254982|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
1254983|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
1254984|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
1254985|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
1254986|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
1254987|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
1254988|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
1254989|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
1254990|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
1254991|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
1254992|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
1254993|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
1255089|NCT00074802|E1|Reported Event|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
1254994|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
1254995|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
1254996|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
1254997|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
1254998|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
1254999|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
1255000|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
1255001|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
1255002|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
1255003|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
1255004|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
1255005|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
1255006|NCT00075218|E3|Reported Event|Sunitinib Open-Label Treatment|Subjects experiencing disease progression could have their treatment assignment unblinded, and subjects who had been receiving placebo could crossover to open-label treatment with sunitinib; subjects who had been receiving sunitinib during double-blind treatment of the study could continue to do so after unblinding if, in the opinion of the investigator, there was sufficient evidence of clinical benefit.
1255007|NCT00075218|E2|Reported Event|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
1255008|NCT00075218|E1|Reported Event|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
1255009|NCT00075088|B3|Baseline|Total|Total of all reporting groups
1255010|NCT00075088|B2|Baseline|Routine Clinical Practice|Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
1255011|NCT00075088|B1|Baseline|Electrocardiogram (ECG) Intervention|Patients randomized to the experimental group had their ECGs printed out in the target ED with an audible voice alarm. Print-out of the pre-hospital ECG in the target ED was the intervention.
1255012|NCT00075088|P2|Participant Flow|Routine Clinical Practice|Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
1255013|NCT00075088|P1|Participant Flow|Electrocardiogram (ECG) Intervention|Patients randomized to the experimental group had their ECGs printed out in the target ED with an audible voice alarm. Print-out of the pre-hospital ECG in the target ED was the intervention.
1255014|NCT00075088|O2|Outcome|Routine Clinical Practice|Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
1255015|NCT00075088|O1|Outcome|Electrocardiogram (ECG) Intervention|Patients randomized to the experimental group had their ECGs printed out in the target ED with an audible voice alarm. Print-out of the pre-hospital ECG in the target ED was the intervention.
1255020|NCT00075088|E3|Reported Event|Prehospital|"At the start of the trial, the IRB requested every death in the pre-hospital period be reported because we put on the study electrocardiogram device in the field with waiver of consent so as not to cause a delay for patients reaching the hospital with possible heart attack. They were consented after they reached the hospital. However, IRB removed this requirement after 40 pre-consent/pre-hospital deaths were reported. The number of pre-hospital participants assessed before and after the IRB changed the reporting requirements cannot be determined from study data, but NA is not a valid entry in the At Risk field."
1255021|NCT00075088|E2|Reported Event|Routine Clinical Practice|Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
1255022|NCT00075088|E1|Reported Event|Electrocardiogram (ECG) Intervention|Patients randomized to the experimental group had their ECGs printed out in the target ED with an audible voice alarm. Print-out of the pre-hospital ECG in the target ED was the intervention.
1255023|NCT00075023|B3|Baseline|Total|Total of all reporting groups
1255024|NCT00075023|B2|Baseline|Placebo|Placebo Gel
1255025|NCT00075023|B1|Baseline|Thalidomide Gel|Thalidomide Gel
1255026|NCT00075023|P2|Participant Flow|Placebo|Placebo Gel
1255027|NCT00075023|P1|Participant Flow|Thalidomide Gel|Thalidomide Gel
1255028|NCT00075023|O2|Outcome|Placebo|Placebo Gel
1255029|NCT00075023|O1|Outcome|Thalidomide Gel|Thalidomide Gel
1255030|NCT00075023|E3|Reported Event|Adverse Events for All Participants|These are adverse events for participants as reported to the DSMB, without information related to treatment arm
1255031|NCT00075023|E2|Reported Event|Placebo|Placebo Gel
1255032|NCT00075023|E1|Reported Event|Thalidomide Gel|Thalidomide Gel
1255033|NCT00074984|B3|Baseline|Total|Total of all reporting groups
1255034|NCT00074984|B2|Baseline|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme (agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
1255035|NCT00074984|B1|Baseline|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks.
1255036|NCT00074984|P2|Participant Flow|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme (agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
1255037|NCT00074984|P1|Participant Flow|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks.
1255038|NCT00074984|O2|Outcome|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme (agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
1255039|NCT00074984|O1|Outcome|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks.
1255040|NCT00074984|O2|Outcome|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme (agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
1255041|NCT00074984|O1|Outcome|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks.
1255042|NCT00074984|O2|Outcome|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme (agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
1255043|NCT00074984|O1|Outcome|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks.
1255044|NCT00074984|O2|Outcome|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme (agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
1255045|NCT00074984|O1|Outcome|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks.
1255046|NCT00074984|O2|Outcome|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme (agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
1255047|NCT00074984|O1|Outcome|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks.
1255048|NCT00074984|E3|Reported Event|Total|All patients.
1255049|NCT00074984|E2|Reported Event|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks
1255062|NCT00074815|P1|Participant Flow|MM + CBT|Participants will receive medication management plus cognitive behavioral therapy with a psychologist
1255063|NCT00074815|O3|Outcome|MM Only|Participants will receive medication management only
1255064|NCT00074815|O2|Outcome|MM + ICBT|Participants will receive medication management plus instructional cognitive behavioral therapy with a psychiatrist
1255065|NCT00074815|O1|Outcome|MM + CBT|Participants will receive medication management plus cognitive behavioral therapy with a psychologist
1255066|NCT00074815|E3|Reported Event|MM Only|Participants will receive medication management only
1255067|NCT00074815|E2|Reported Event|MM + ICBT|Participants will receive medication management plus instructional cognitive behavioral therapy with a psychiatrist
1255068|NCT00074815|E1|Reported Event|MM + CBT|Participants will receive medication management plus cognitive behavioral therapy with a psychologist
1255069|NCT00074802|B3|Baseline|Total|Total of all reporting groups
1255070|NCT00074802|B2|Baseline|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.~Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
1255071|NCT00074802|B1|Baseline|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
1255072|NCT00074802|P2|Participant Flow|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.~Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
1255073|NCT00074802|P1|Participant Flow|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
1255074|NCT00074802|O2|Outcome|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.~Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
1255075|NCT00074802|O1|Outcome|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
1255076|NCT00074802|O2|Outcome|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.~Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
1255077|NCT00074802|O1|Outcome|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
1255078|NCT00074802|O2|Outcome|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.~Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
1255079|NCT00074802|O1|Outcome|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
1255080|NCT00074802|O2|Outcome|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.~Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
1255081|NCT00074802|O1|Outcome|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
1255082|NCT00074802|O2|Outcome|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.~Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
1255083|NCT00074802|O1|Outcome|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
1255084|NCT00074802|O2|Outcome|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.~Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
1255085|NCT00074802|O1|Outcome|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
1255135|NCT00074412|E2|Reported Event|Placebo|For infants: extended treatment with NVP placebo
1255136|NCT00074412|E1|Reported Event|Nevirapine|For infants: extended treatment with NVP
1255086|NCT00074802|O2|Outcome|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.~Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
1255087|NCT00074802|O1|Outcome|Paroxetine Continuation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day."
1255088|NCT00074802|E2|Reported Event|Paroxetine With CBT Augmentation|"Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.~Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions."
1255090|NCT00074711|B3|Baseline|Total|Total of all reporting groups
1255094|NCT00074711|P1|Participant Flow|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
1255095|NCT00074711|O2|Outcome|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
1255096|NCT00074711|O1|Outcome|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
1255097|NCT00074711|O2|Outcome|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
1255098|NCT00074711|O1|Outcome|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
1255099|NCT00074711|O2|Outcome|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
1255100|NCT00074711|O1|Outcome|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
1255101|NCT00074711|O2|Outcome|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
1255102|NCT00074711|O1|Outcome|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
1255103|NCT00074711|O2|Outcome|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
1255104|NCT00074711|O1|Outcome|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
1255105|NCT00074711|O2|Outcome|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
1255106|NCT00074711|O1|Outcome|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
1255107|NCT00074711|E2|Reported Event|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
1255108|NCT00074711|E1|Reported Event|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
1255109|NCT00074581|B3|Baseline|Total|Total of all reporting groups
1255110|NCT00074581|B2|Baseline|Delayed-ART|"Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART.~(Same drug regimen as that described in the early-ART arm)~Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible."
1255111|NCT00074581|B1|Baseline|Early-ART|"Participants will begin ART in addition to receiving HIV primary care~Atazanavir: 300 mg taken orally once daily~Didanosine: 400 mg taken orally once daily~Efavirenz: 600 mg taken orally once daily~Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily~Lamivudine: 300 mg taken orally once daily~Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily~Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily~Stavudine: Dosage depends on weight~Tenofovir disoproxil fumarate: 300 mg taken orally once daily~Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily~Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided."
1255112|NCT00074581|P2|Participant Flow|Delayed-ART|"Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART.~(Same drug regimen as that described in the early-ART arm)~Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible."
1255137|NCT00074269|B1|Baseline|Pilot Study of Allogeneic Transplant for Metastatic Breast Can|"anti-thymocyte globulin~filgrastim~graft-versus-tumor induction therapy~therapeutic allogeneic lymphocytes~cyclosporine~fludarabine phosphate~melphalan~methotrexate~peripheral blood stem cell transplantation"
1255138|NCT00074269|P1|Participant Flow|Treatment|"anti-thymocyte globulin~filgrastim~graft-versus-tumor induction therapy~therapeutic allogeneic lymphocytes~cyclosporine~fludarabine phosphate~melphalan~methotrexate~peripheral blood stem cell transplantation"
1255139|NCT00074269|O1|Outcome|Treatment|"Toxicity~anti-thymocyte globulin~filgrastim~graft-versus-tumor induction therapy~therapeutic allogeneic lymphocytes~cyclosporine~fludarabine phosphate~melphalan~methotrexate~peripheral blood stem cell transplantation"
1255113|NCT00074581|P1|Participant Flow|Early-ART|"Participants will begin ART in addition to receiving HIV primary care~Atazanavir: 300 mg taken orally once daily~Didanosine: 400 mg taken orally once daily~Efavirenz: 600 mg taken orally once daily~Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily~Lamivudine: 300 mg taken orally once daily~Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily~Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily~Stavudine: Dosage depends on weight~Tenofovir disoproxil fumarate: 300 mg taken orally once daily~Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily~Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided."
1255114|NCT00074581|O2|Outcome|Delayed-ART|"Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART.~(Same drug regimen as that described in the early-ART arm)~Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible."
1255144|NCT00074165|O1|Outcome|Rituximab and Carboplatin|Rituximab: (i.v.) 375 mg/m^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m^2 /day x 2 days = 400 mg/m^2
1255145|NCT00074165|E1|Reported Event|Rituximab and Carboplatin|Rituximab: (i.v.) 375 mg/m^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m^2 /day x 2 days = 400 mg/m^2
1255146|NCT00074152|B3|Baseline|Total|Total of all reporting groups
1255403|NCT00072293|B3|Baseline|Total|Total of all reporting groups
1255115|NCT00074581|O1|Outcome|Early-ART|"Participants will begin ART in addition to receiving HIV primary care~Atazanavir: 300 mg taken orally once daily~Didanosine: 400 mg taken orally once daily~Efavirenz: 600 mg taken orally once daily~Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily~Lamivudine: 300 mg taken orally once daily~Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily~Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily~Stavudine: Dosage depends on weight~Tenofovir disoproxil fumarate: 300 mg taken orally once daily~Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily~Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided."
1255116|NCT00074581|O2|Outcome|Delayed-ART|"Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART.~(Same drug regimen as that described in the early-ART arm)~Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible."
1255117|NCT00074581|O1|Outcome|Early-ART|"Participants will begin ART in addition to receiving HIV primary care~Atazanavir: 300 mg taken orally once daily~Didanosine: 400 mg taken orally once daily~Efavirenz: 600 mg taken orally once daily~Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily~Lamivudine: 300 mg taken orally once daily~Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily~Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily~Stavudine: Dosage depends on weight~Tenofovir disoproxil fumarate: 300 mg taken orally once daily~Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily~Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided."
1255118|NCT00074581|E2|Reported Event|Delayed-ART|"Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART.~(Same drug regimen as that described in the early-ART arm)~Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible."
1255119|NCT00074581|E1|Reported Event|Early-ART|"Participants will begin ART in addition to receiving HIV primary care~Atazanavir: 300 mg taken orally once daily~Didanosine: 400 mg taken orally once daily~Efavirenz: 600 mg taken orally once daily~Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily~Lamivudine: 300 mg taken orally once daily~Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily~Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily~Stavudine: Dosage depends on weight~Tenofovir disoproxil fumarate: 300 mg taken orally once daily~Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily~Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided."
1255120|NCT00074412|B3|Baseline|Total|Total of all reporting groups
1255121|NCT00074412|B2|Baseline|Placebo|For infants: extended treatment with NVP placebo
1255122|NCT00074412|B1|Baseline|Nevirapine|For infants: extended treatment with NVP
1255123|NCT00074412|P2|Participant Flow|Nevirapine|For infants: extended treatment with NVP
1255124|NCT00074412|P1|Participant Flow|Placebo|For infants: extended treatment with NVP placebo
1255125|NCT00074412|O2|Outcome|Placebo|For infants: extended treatment with NVP placebo
1255126|NCT00074412|O1|Outcome|Nevirapine|For infants: extended treatment with NVP
1255127|NCT00074412|O2|Outcome|Placebo|For infants: extended treatment with NVP placebo
1255128|NCT00074412|O1|Outcome|Nevirapine|For infants: extended treatment with NVP
1255129|NCT00074412|O2|Outcome|Placebo|For infants: extended treatment with NVP placebo
1255130|NCT00074412|O1|Outcome|Nevirapine|For infants: extended treatment with NVP
1255131|NCT00074412|O2|Outcome|Placebo|For infants: extended treatment with NVP placebo
1255132|NCT00074412|O1|Outcome|Nevirapine|For infants: extended treatment with NVP
1255133|NCT00074412|O2|Outcome|Placebo|For infants: extended treatment with NVP Placebo
1255140|NCT00074269|E1|Reported Event|Treatment|"incidence of Toxicity~administration of filgrastim~Grade of GVHD~Initiation of graft-versus-tumor induction therapy~Disease Status"
1255141|NCT00074165|B1|Baseline|Rituximab and Carboplatin|Rituximab: (i.v.) 375 mg/m^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m^2 /day x 2 days = 400 mg/m^2
1255142|NCT00074165|P1|Participant Flow|Rituximab and Carboplatin|Rituximab: (i.v.) 375 mg/m^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m^2 /day x 2 days = 400 mg/m^2
1255143|NCT00074165|O1|Outcome|Rituximab and Carboplatin|Rituximab: (i.v.) 375 mg/m^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m^2 /day x 2 days = 400 mg/m^2
1255480|NCT00071890|O1|Outcome|Interleukin-2 Group|HAART and tree cycles of IL-2
1255147|NCT00074152|B2|Baseline|Arm II|"Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.~chemotherapy: Given within 10 weeks after surgery."
1255148|NCT00074152|B1|Baseline|Arm I|"Observation (+/- Radiation). Patients receive radiotherapy* within 6 months after surgery.~radiation therapy: Given within 6 months after surgery"
1255149|NCT00074152|P2|Participant Flow|Chemotherapy|"Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.~chemotherapy: Given within 10 weeks after surgery."
1255150|NCT00074152|P1|Participant Flow|Observation|"Observation (+/- Radiation). Patients receive radiotherapy* within 6 months after surgery.~radiation therapy: Given within 6 months after surgery"
1255151|NCT00074152|O2|Outcome|Arm II|"Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.~chemotherapy: Given within 10 weeks after surgery."
1255152|NCT00074152|O1|Outcome|Arm I|"Observation (+/- Radiation).Patients receive radiotherapy* within 6 months after surgery.~radiation therapy: Given within 6 months after surgery"
1255153|NCT00074152|O2|Outcome|Arm II|"Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.~chemotherapy: Given within 10 weeks after surgery."
1255154|NCT00074152|O1|Outcome|Arm I|"Observation (+/- Radiation).Patients receive radiotherapy* within 6 months after surgery.~radiation therapy: Given within 6 months after surgery"
1255155|NCT00074152|O2|Outcome|Arm II|"Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.~chemotherapy: Given within 10 weeks after surgery."
1255156|NCT00074152|O1|Outcome|Arm I|"Observation (+/- Radiation). Patients receive radiotherapy* within 6 months after surgery.~radiation therapy: Given within 6 months after surgery"
1255157|NCT00074152|E2|Reported Event|Arm II|"Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.~chemotherapy: Given within 10 weeks after surgery."
1255158|NCT00074152|E1|Reported Event|Arm I|"Observation (+/- Radiation). Patients receive radiotherapy* within 6 months after surgery.~radiation therapy: Given within 6 months after surgery"
1255159|NCT00074035|B1|Baseline|Pentostatin|pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks
1255160|NCT00074035|P1|Participant Flow|Pentostatin|pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks
1255161|NCT00074035|O1|Outcome|Pentostatin|pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks
1255162|NCT00074035|O1|Outcome|Pentostatin|pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks
1255163|NCT00074035|O1|Outcome|Pentostatin|pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks
1255164|NCT00074035|O1|Outcome|Pentostatin|pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks
1255165|NCT00074035|E1|Reported Event|Pentostatin|pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks
1255166|NCT00073983|B1|Baseline|Combination Chemotherapy|Gemcitibine 675 mg/m^2 given intravenous (IV) on day 1 and 8; docetaxel 75 mg/m^2 given IV on day 8 after gemcitibine. Each cycle is 21 days. Cycles of chemotherapy administered until off study criteria met.
1255167|NCT00073983|P1|Participant Flow|Combination Chemotherapy|Gemcitibine 675 mg/m^2 given intravenous (IV) on day 1 and 8; docetaxel 75 mg/m^2 given IV on day 8 after gemcitibine. Each cycle is 21 days. Cycles of chemotherapy administered until off study criteria met.
1255168|NCT00073983|O3|Outcome|Chondrosarcoma|Combination chemotherapy
1255169|NCT00073983|O2|Outcome|Osteosarcoma|Combination Chemotherapy
1255170|NCT00073983|O1|Outcome|Ewing's Sarcoma|Combination chemotherapy
1255171|NCT00073983|O3|Outcome|Chondrosarcoma|Combination chemotherapy
1255172|NCT00073983|O2|Outcome|Osteosarcoma|Combination Chemotherapy
1255173|NCT00073983|O1|Outcome|Ewing's Sarcoma|Combination chemotherapy
1255174|NCT00073983|O3|Outcome|Chondrosarcoma|Combination chemotherapy
1255175|NCT00073983|O2|Outcome|Osteosarcoma|Combination Chemotherapy
1255176|NCT00073983|O1|Outcome|Ewing's Sarcoma|Combination chemotherapy
1255177|NCT00073983|O3|Outcome|Chondrosarcoma|Combination chemotherapy
1255178|NCT00073983|O2|Outcome|Osteosarcoma|Combination Chemotherapy
1255179|NCT00073983|O1|Outcome|Ewing's Sarcoma|Combination chemotherapy
1255180|NCT00073983|E1|Reported Event|Combination Chemotherapy|Gemcitibine 675 mg/m^2 given intravenous (IV) on day 1 and 8; docetaxel 75 mg/m^2 given IV on day 8 after gemcitibine. Each cycle is 21 days. Cycles of chemotherapy administered until off study criteria met.
1255364|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
1255181|NCT00073918|B1|Baseline|Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)|"RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.~CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.~AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.~cyclophosphamide: Given IV~etoposide: Given IV~iodine I 131 tositumomab: Given IV~quality-of-life assessment: Ancillary study~peripheral blood stem cell transplantation: Undergo ASCT given via central catheter"
1255313|NCT00073021|P1|Participant Flow|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
1255481|NCT00071890|O2|Outcome|Control Group|HAART alone (without Interleukin-2)
1255182|NCT00073918|P1|Participant Flow|Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)|"RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.~CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.~AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.~cyclophosphamide: Given IV~etoposide: Given IV~iodine I 131 tositumomab: Given IV~quality-of-life assessment: Ancillary study~peripheral blood stem cell transplantation: Undergo ASCT given via central catheter"
1255183|NCT00073918|O1|Outcome|Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)|"RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.~CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.~AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.~cyclophosphamide: Given IV~etoposide: Given IV~iodine I 131 tositumomab: Given IV~quality-of-life assessment: Ancillary study~peripheral blood stem cell transplantation: Undergo ASCT given via central catheter"
1255184|NCT00073918|O1|Outcome|Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)|"RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.~CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.~AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.~cyclophosphamide: Given IV~etoposide: Given IV~iodine I 131 tositumomab: Given IV~quality-of-life assessment: Ancillary study~peripheral blood stem cell transplantation: Undergo ASCT given via central catheter"
1255185|NCT00073918|E1|Reported Event|Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)|"RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.~CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.~AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.~cyclophosphamide: Given IV~etoposide: Given IV~iodine I 131 tositumomab: Given IV~quality-of-life assessment: Ancillary study~peripheral blood stem cell transplantation: Undergo ASCT given via central catheter"
1255186|NCT00073528|B3|Baseline|Total|Total of all reporting groups
1255187|NCT00073528|B2|Baseline|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255188|NCT00073528|B1|Baseline|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255189|NCT00073528|P2|Participant Flow|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255190|NCT00073528|P1|Participant Flow|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255191|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255192|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255193|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255194|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255195|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255482|NCT00071890|O1|Outcome|Interleukin-2 Group|HAART and tree cycles of IL-2
1255483|NCT00071890|O2|Outcome|Control Group|HAART alone (without Interleukin-2)
1255196|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255197|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255198|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255199|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255200|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255201|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255202|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255203|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255204|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255205|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255206|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255207|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255208|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255289|NCT00073307|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
1255290|NCT00073307|O2|Outcome|Placebo|Subjects received matching placebo tablets administered orally twice a day. [until ~31 May 2005]
1255209|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255210|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255211|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255212|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255213|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255214|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255215|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255216|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255217|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255218|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255219|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255220|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255221|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255222|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255223|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255224|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255225|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255226|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255227|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255228|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255229|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255230|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255231|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255232|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255233|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255234|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255235|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255236|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255237|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255238|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255239|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255240|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255241|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255242|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255243|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255244|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255245|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255246|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255247|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255248|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255249|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255250|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255251|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255252|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255253|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255254|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255255|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255256|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255257|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255258|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255259|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255260|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255261|NCT00073528|E2|Reported Event|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255262|NCT00073528|E1|Reported Event|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
1255263|NCT00073333|B4|Baseline|Total|Total of all reporting groups
1255264|NCT00073333|B3|Baseline|Attention Placebo Control|Placebo - attention placebo control condition consisting of weekly telephone contact
1255265|NCT00073333|B2|Baseline|2Imaginal and in Vivo Exposure|Exposure treatment - imaginal and in vivo exposure conducted twice per week
1255266|NCT00073333|B1|Baseline|1Social Effectiveness Therapy|Social skills training and exposure therapy - each conducted once per week.
1255267|NCT00073333|P3|Participant Flow|3Attention Placebo|Placebo - attention placebo control condition consisting of weekly telephone contact of ten minutes during which clinical status, particularly level of depression was assessed. There was no other contact
1255268|NCT00073333|P2|Participant Flow|2Imaginal and In Vivo Exposure|Exposure treatment - imaginal and in vivo exposure conducted twice per week for entire study. Imaginal was instituted first followed by in vivo exposure in the form of programmed practice
1255269|NCT00073333|P1|Participant Flow|1Social Effectiveness Therapy|Social skills training and exposure therapy - each conducted once per week. Social Skills was conducted in groups of 4-6 participants. Exposure was individual therapy conducted weekly.
1255270|NCT00073333|O3|Outcome|Attention Placebo Control|Placebo - attention placebo control condition consisting of weekly telephone contact
1255271|NCT00073333|O2|Outcome|Imaginal and In Vivo Exposure|Exposure treatment - imaginal and in vivo exposure conducted twice per week
1255272|NCT00073333|O1|Outcome|Social Effectiveness Therapy|Social skills training and exposure therapy - each conducted once per week.
1255273|NCT00073333|E3|Reported Event|Attention Placebo Control|Placebo - attention placebo control condition consisting of weekly telephone contact
1255274|NCT00073333|E2|Reported Event|Imaginal and In Vivo Exposure|Exposure treatment - imaginal and in vivo exposure conducted twice per week
1255275|NCT00073333|E1|Reported Event|Social Effectiveness Therapy|Social skills training and exposure therapy - each conducted once per week.
1255276|NCT00073307|B3|Baseline|Total|Total of all reporting groups
1255277|NCT00073307|B2|Baseline|Placebo|Subjects received matching placebo tablets administered orally twice a day. [until ~31 May 2005]
1255278|NCT00073307|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
1255279|NCT00073307|P3|Participant Flow|Placebo Randomized, Switch to Sorafenib; Sorafenib Period Only|Subjects received matching placebo tablets administered orally twice a day(as of ~31 May 2005) when after unblinding subjects switched over to receive Sorafenib orally administered as 2 x 200 mg tablets bid (twice daily).
1255280|NCT00073307|P2|Participant Flow|Placebo|Subjects received matching placebo tablets administered orally twice a day. [until ~31 May 2005]
1255281|NCT00073307|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily).
1255282|NCT00073307|O2|Outcome|Placebo|Subjects received matching placebo tablets administered orally twice a day. [until ~31 May 2005]
1255283|NCT00073307|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
1255284|NCT00073307|O2|Outcome|Placebo|Subjects received matching placebo tablets administered orally twice a day. [until ~31 May 2005]
1255285|NCT00073307|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
1255286|NCT00073307|O2|Outcome|Placebo|Placebo tablets matching in appearance were to be orally administered twice a day.
1255287|NCT00073307|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
1255288|NCT00073307|O2|Outcome|Placebo|Placebo tablets matching in appearance were to be orally administered twice a day.
1255362|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
1255291|NCT00073307|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
1255292|NCT00073307|O2|Outcome|Placebo|Subjects received matching placebo tablets administered orally twice a day. [until ~31 May 2005]
1255293|NCT00073307|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
1255294|NCT00073307|E4|Reported Event|Placebo ~31May2005, Then Switched to Sorafenib Only-30Jun2008|Sorafenib period only-30Jun2008: Subjects received matching placebo tablets administered orally twice a day(as of ~31 May 2005) when after unblinding subjects switched over to receive Sorafenib orally administered as 2 x 200 mg tablets bid (twice daily). Open Label/Sorafenib only period-30Jun2008
1255314|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
1255295|NCT00073307|E3|Reported Event|Sorafenib (Nexavar, BAY43-9006)-30Jun2008|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Double Blind-30Jun2008. In addition, 1 participant who was not randomized to double-blind treatment received sorafenib treatment on a compassionate-use basis in the open-label/Sorafenib only phase and was included in the safety population only. Participants affected may deviate from double-blind phase due to data update and cleaning.
1255296|NCT00073307|E2|Reported Event|Placebo-31May2005 DB|Subjects received matching placebo tablets administered orally twice a day. [until ~31 May 2005]
1255297|NCT00073307|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)-31May2005 DB|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Double Blind period-31May2005
1255298|NCT00073073|B1|Baseline|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
1255299|NCT00073073|P1|Participant Flow|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
1255300|NCT00073073|O1|Outcome|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
1255301|NCT00073073|O1|Outcome|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
1255302|NCT00073073|O1|Outcome|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
1255303|NCT00073073|O1|Outcome|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
1255304|NCT00073073|O1|Outcome|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
1255305|NCT00073073|O1|Outcome|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
1255306|NCT00073073|O1|Outcome|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
1255307|NCT00073073|O1|Outcome|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
1255308|NCT00073073|E1|Reported Event|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
1255309|NCT00073021|B3|Baseline|Total|Total of all reporting groups
1255310|NCT00073021|B2|Baseline|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
1255311|NCT00073021|B1|Baseline|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
1255312|NCT00073021|P2|Participant Flow|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
1255319|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
1255320|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
1255321|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
1255322|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
1255323|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
1255324|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
1255325|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
1255326|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
1255327|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
1255328|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
1255329|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
1255330|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
1255331|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
1255332|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
1255333|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
1255334|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
1255335|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
1255336|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
1255337|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
1255338|NCT00073021|E2|Reported Event|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
1255339|NCT00073021|E1|Reported Event|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
1255340|NCT00073008|B3|Baseline|Total|Total of all reporting groups
1255341|NCT00073008|B2|Baseline|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
1255342|NCT00073008|B1|Baseline|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
1255343|NCT00073008|P2|Participant Flow|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
1255344|NCT00073008|P1|Participant Flow|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
1255345|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
1255346|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
1255347|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
1255348|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
1255349|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
1255350|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
1255351|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
1255352|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
1255353|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
1255354|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
1255355|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
1255356|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
1255357|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
1255358|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
1255359|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
1255360|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
1255361|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
1255365|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
1255366|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
1255367|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
1255368|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
1255369|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
1255370|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
1255371|NCT00073008|E2|Reported Event|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
1255372|NCT00073008|E1|Reported Event|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
1255374|NCT00072761|B2|Baseline|Observation Group|The observation group received standard care therapy and quarterly physical examination by a study hematologist for 36 months.
1255375|NCT00072761|B1|Baseline|Transfusion Group|The transfusion Group received blood transfusion therapy every 4-6 weeks for 36 months.
1255376|NCT00072761|P2|Participant Flow|Observation Group|The observation group received standard care therapy and quarterly physical examination by a study hematologist for 36 months.
1255377|NCT00072761|P1|Participant Flow|Transfusion Group|The transfusion group received blood transfusion therapy every 4-6 weeks for 36 months.
1255378|NCT00072761|O2|Outcome|Observation Group|The observation group received standard care therapy and quarterly physical examination by a study hematologist for 36 months.
1255379|NCT00072761|O1|Outcome|Transfusion Group|The transfusion Group received blood transfusion therapy every 4-6 weeks for 36 months.
1255380|NCT00072761|E2|Reported Event|Observation Group|The observation Group received standard care therapy and quarterly physical examination by a study hematologist for 36 months.
1255381|NCT00072761|E1|Reported Event|Transfusion Group|The transfusion Group received blood transfusion therapy every 4-6 weeks for 36 months.
1255382|NCT00072566|B1|Baseline|Treatment (Bevacizumab, Cyclophosphamide)|"Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~cyclophosphamide: Given PO"
1255383|NCT00072566|P1|Participant Flow|Treatment (Bevacizumab, Cyclophosphamide)|"Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~cyclophosphamide: Given PO"
1255384|NCT00072566|O1|Outcome|Treatment (Bevacizumab, Cyclophosphamide)|"Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~cyclophosphamide: Given PO"
1255385|NCT00072566|O1|Outcome|Treatment (Bevacizumab, Cyclophosphamide)|"Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~cyclophosphamide: Given PO"
1255386|NCT00072566|O1|Outcome|Treatment (Bevacizumab, Cyclophosphamide)|"Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~cyclophosphamide: Given PO"
1255387|NCT00072566|E1|Reported Event|Treatment (Bevacizumab, Cyclophosphamide)|"Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~cyclophosphamide: Given PO"
1255388|NCT00072475|B1|Baseline|Vatalanib|"Adult patients with MDS receive treatment with vatalanib.~vatalanib: Pts registered before 1/15/05 1250 mg/day PO~After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)"
1255389|NCT00072475|P1|Participant Flow|Vatalanib|"Adult patients with MDS receive treatment with vatalanib.~vatalanib: Pts registered before 1/15/05 1250 mg/day PO~After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)"
1255390|NCT00072475|O1|Outcome|Vatalanib|"Adult patients with MDS receive treatment with vatalanib.~vatalanib: Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)"
1255391|NCT00072475|O1|Outcome|Vatalanib|"Adult patients with MDS receive treatment with vatalanib.~vatalanib: Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)"
1255392|NCT00072475|O1|Outcome|Vatalanib|"Adult patients with MDS receive treatment with vatalanib.~vatalanib: Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)"
1255393|NCT00072475|O1|Outcome|Vatalanib|"Adult patients with MDS receive treatment with vatalanib.~vatalanib: Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)"
1255394|NCT00072475|O1|Outcome|Vatalanib|"Adult patients with MDS receive treatment with vatalanib.~vatalanib: Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)"
1255395|NCT00072475|E1|Reported Event|Vatalanib|After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)
1255396|NCT00072449|B1|Baseline|Rituximab Monotherapy|Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
1255837|NCT00070499|O2|Outcome|High Dose Imatinib|Patients received 800 mg imatinib daily
1255397|NCT00072449|P1|Participant Flow|Rituximab Monotherapy|Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
1255398|NCT00072449|O1|Outcome|Rituximab Monotherapy|Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
1255399|NCT00072449|O1|Outcome|Rituximab Monotherapy|Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
1255400|NCT00072449|O1|Outcome|Rituximab Monotherapy|Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
1255401|NCT00072449|O1|Outcome|Rituximab Monotherapy|Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
1255402|NCT00072449|E1|Reported Event|Rituximab Monotherapy|Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
1255404|NCT00072293|B2|Baseline|No Axillary Dissection|"Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.~No axillary lymph node dissection: Therapeutic conventional surgery"
1255405|NCT00072293|B1|Baseline|Axillary Dissection|"Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.~Axillary lymph node dissection: Axillary lymph node dissection"
1255406|NCT00072293|P2|Participant Flow|No Axillary Dissection|"Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.~No axillary lymph node dissection: Therapeutic conventional surgery"
1255407|NCT00072293|P1|Participant Flow|Axillary Dissection|"Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.~Axillary lymph node dissection: Axillary lymph node dissection"
1255408|NCT00072293|O2|Outcome|No Axillary Dissection|"Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.~No axillary lymph node dissection: Therapeutic conventional surgery"
1255409|NCT00072293|O1|Outcome|Axillary Dissection|"Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.~Axillary lymph node dissection: Axillary lymph node dissection"
1255410|NCT00072293|O2|Outcome|No Axillary Dissection|"Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.~No axillary lymph node dissection: Therapeutic conventional surgery"
1255411|NCT00072293|O1|Outcome|Axillary Dissection|"Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.~Axillary lymph node dissection: Axillary lymph node dissection"
1255412|NCT00072293|O2|Outcome|No Axillary Dissection|"Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.~No axillary lymph node dissection: Therapeutic conventional surgery"
1255413|NCT00072293|O1|Outcome|Axillary Dissection|"Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.~Axillary lymph node dissection: Axillary lymph node dissection"
1255414|NCT00072293|E2|Reported Event|No Axillary Dissection|"Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.~No axillary lymph node dissection: Therapeutic conventional surgery"
1255415|NCT00072293|E1|Reported Event|Axillary Dissection|"Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.~Axillary lymph node dissection: Axillary lymph node dissection"
1255416|NCT00072280|B3|Baseline|Total|Total of all reporting groups
1255417|NCT00072280|B2|Baseline|Surgery Only|Comprised of patients with initially resectable disease lesions. All patients undergo Conventional Surgery. Those with a result of clear or microscopically positive margins remain on study in this arm, for observation with no further intervention.
1255418|NCT00072280|B1|Baseline|Chemotherapy Plus Possible Surgery|"Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery.~(See Interventions section for drug dosage and administration details.)"
1255419|NCT00072280|P2|Participant Flow|Surgery Only|Comprised of patients with initially resectable disease lesions. All patients undergo Conventional Surgery. Those with a result of clear or microscopically positive margins remain on study in this arm, for observation with no further intervention.
1255420|NCT00072280|P1|Participant Flow|Chemotherapy Plus Possible Surgery|"Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery.~(See Interventions section for drug dosage and administration details.)"
1255421|NCT00072280|O1|Outcome|Chemotherapy Plus Possible Surgery|"Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery.~(See Interventions section for drug dosage and administration details.)"
1255422|NCT00072280|E2|Reported Event|Surgery Only|Comprised of patients with initially resectable disease lesions. All patients undergo Conventional Surgery. Those with a result of clear or microscopically positive margins remain on study in this arm, for observation with no further intervention.
1255423|NCT00072280|E1|Reported Event|Chemotherapy Plus Possible Surgery|"Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery.~(See Interventions section for drug dosage and administration details.)"
1255424|NCT00072189|B1|Baseline|Arm 1|"Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~7-hydroxystaurosporine: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1255425|NCT00072189|P1|Participant Flow|Arm 1|"Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~7-hydroxystaurosporine: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1255484|NCT00071890|O1|Outcome|Interleukin-2 Group|HAART and tree cycles of IL-2
1255485|NCT00071890|E2|Reported Event|Control Group|HAART alone (without Interleukin-2)
1255426|NCT00072189|O1|Outcome|Arm 1|"Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~7-hydroxystaurosporine: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1255427|NCT00072189|O1|Outcome|Arm 1|"Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~7-hydroxystaurosporine: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1255428|NCT00072189|O1|Outcome|Arm 1|"Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~7-hydroxystaurosporine: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1255429|NCT00072189|E1|Reported Event|Arm 1|"Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~7-hydroxystaurosporine: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1255430|NCT00072176|B3|Baseline|Total|Total of all reporting groups
1255431|NCT00072176|B2|Baseline|Group B|"Chemotherapy treated patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
1255432|NCT00072176|B1|Baseline|Group A|"Chemotherapy naive patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
1255433|NCT00072176|P2|Participant Flow|Group B|"Chemotherapy treated patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
1255434|NCT00072176|P1|Participant Flow|Group A|"Chemotherapy naive patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
1255435|NCT00072176|O2|Outcome|Group B|"Chemotherapy treated patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
1255436|NCT00072176|O1|Outcome|Group A|"Chemotherapy naive patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
1255437|NCT00072176|O2|Outcome|Group B|"Chemotherapy treated patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
1255438|NCT00072176|O1|Outcome|Group A|"Chemotherapy naive patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
1255439|NCT00072176|E2|Reported Event|Group B|"Chemotherapy treated patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
1255440|NCT00072176|E1|Reported Event|Group A|"Chemotherapy naive patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
1255441|NCT00071981|B5|Baseline|Total|Total of all reporting groups
1255442|NCT00071981|B4|Baseline|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
1255443|NCT00071981|B3|Baseline|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
1255444|NCT00071981|B2|Baseline|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~tetanus peptide melanoma vaccine : Given by injection"
1255521|NCT00071812|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255445|NCT00071981|B1|Baseline|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection"
1255446|NCT00071981|P4|Participant Flow|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
1255486|NCT00071890|E1|Reported Event|Interleukin-2 Group|HAART and tree cycles of IL-2
1255447|NCT00071981|P3|Participant Flow|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
1255448|NCT00071981|P2|Participant Flow|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~tetanus peptide melanoma vaccine : Given by injection"
1255449|NCT00071981|P1|Participant Flow|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection"
1255450|NCT00071981|O4|Outcome|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
1255451|NCT00071981|O3|Outcome|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
1255452|NCT00071981|O2|Outcome|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~tetanus peptide melanoma vaccine : Given by injection"
1255453|NCT00071981|O1|Outcome|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection"
1255454|NCT00071981|O4|Outcome|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
1255455|NCT00071981|O3|Outcome|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
1255456|NCT00071981|O2|Outcome|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~tetanus peptide melanoma vaccine : Given by injection"
1255457|NCT00071981|O1|Outcome|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection"
1255458|NCT00071981|O4|Outcome|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
1255459|NCT00071981|O3|Outcome|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
1255460|NCT00071981|O2|Outcome|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~tetanus peptide melanoma vaccine : Given by injection"
1255461|NCT00071981|O1|Outcome|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection"
1255462|NCT00071981|O4|Outcome|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
1255463|NCT00071981|O3|Outcome|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
1255464|NCT00071981|O2|Outcome|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~tetanus peptide melanoma vaccine : Given by injection"
1255465|NCT00071981|O1|Outcome|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection"
1255466|NCT00071981|O4|Outcome|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
1255467|NCT00071981|O3|Outcome|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
1255468|NCT00071981|O2|Outcome|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~tetanus peptide melanoma vaccine : Given by injection"
1255469|NCT00071981|O1|Outcome|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection"
1255470|NCT00071981|E4|Reported Event|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
1255471|NCT00071981|E3|Reported Event|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
1255472|NCT00071981|E2|Reported Event|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~tetanus peptide melanoma vaccine : Given by injection"
1255473|NCT00071981|E1|Reported Event|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection"
1255474|NCT00071890|B3|Baseline|Total|Total of all reporting groups
1255475|NCT00071890|B2|Baseline|Control Group|HAART alone (without Interleukin-2)
1255476|NCT00071890|B1|Baseline|Interleukin-2 Group|HAART and tree cycles of IL-2
1255477|NCT00071890|P2|Participant Flow|Control Group|HAART alone (without Interleukin-2)
1255478|NCT00071890|P1|Participant Flow|Interleukin-2 Group|HAART and tree cycles of IL-2
1255479|NCT00071890|O2|Outcome|Control Group|HAART alone (without Interleukin-2)
1255490|NCT00071812|B2|Baseline|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255491|NCT00071812|B1|Baseline|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255492|NCT00071812|P4|Participant Flow|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study. The 24 week-open label extension period of the study included patients who completed the 24-week double-blind period and opted to continue in the 24-week open-label period of the study and included patients who were originally randomized to the belimumab 10 mg/kg group in the double-blind period, patients who switched to belimumab 10 mg/kg at the investigator's discretion, and former placebo patients.
1255493|NCT00071812|P3|Participant Flow|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study. The 24-week open-label extension period of the study included patients who completed the 24-week double-blind period and opted to continue to receive the same dose in the 24-week open-label extension period of the study.
1255494|NCT00071812|P2|Participant Flow|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study. The 24-week open-label extension period of the study included patients who completed the 24-week double-blind period and opted to continue to receive the same dose in the 24-week open-label extension period of the study.
1255495|NCT00071812|P1|Participant Flow|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study.
1255496|NCT00071812|O5|Outcome|Open-label Extension Period: All Active|Includes all patients who completed the 24-week double-blind period and opted to continue in a 24-week open-label extension period. Belimumab patients received the same dose or were switched to 10 mg/kg at the investigator's discretion and former placebo patients received belimumab 10 mg/kg. AE onset may be during the extension phase or continuing from the double-blind period.
1255497|NCT00071812|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255498|NCT00071812|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255499|NCT00071812|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255500|NCT00071812|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255501|NCT00071812|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255502|NCT00071812|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255503|NCT00071812|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255504|NCT00071812|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255505|NCT00071812|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255506|NCT00071812|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255507|NCT00071812|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255508|NCT00071812|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255509|NCT00071812|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255510|NCT00071812|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255511|NCT00071812|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255512|NCT00071812|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255513|NCT00071812|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255514|NCT00071812|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255515|NCT00071812|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255516|NCT00071812|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255517|NCT00071812|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255518|NCT00071812|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255519|NCT00071812|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255520|NCT00071812|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255522|NCT00071812|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255523|NCT00071812|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255524|NCT00071812|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255525|NCT00071812|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255526|NCT00071812|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255527|NCT00071812|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255529|NCT00071812|E5|Reported Event|Open-label Extension Period: All Active|Includes all patients who completed the 24-week double blind period and opted to continue in the 24-week open-label extension period. Belimumab patients received the same dose or were switched to 10 mg/kg at investigator discretion and former placebo patients received belimumab 10 mg/kg. AE onset may be during the extension phase or continuing from the double-blind period.
1255530|NCT00071812|E4|Reported Event|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255531|NCT00071812|E3|Reported Event|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255532|NCT00071812|E2|Reported Event|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255533|NCT00071812|E1|Reported Event|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
1255534|NCT00071799|B3|Baseline|Total|Total of all reporting groups
1255535|NCT00071799|B2|Baseline|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
1255536|NCT00071799|B1|Baseline|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
1255537|NCT00071799|P2|Participant Flow|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
1255538|NCT00071799|P1|Participant Flow|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
1255539|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
1255540|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
1255541|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
1255542|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
1255543|NCT00071799|O4|Outcome|Standard Chemotherapy|Induction cycle: Cytarabine infusion 100-200 mg/m2/day on days 1-7 + anthracycline on days 1, 2, 3 Consolidation cycle: Cytarabine infusion 100-200 mg/m2/day for 3-7 days + anthracycline on days 1 and 2 There are 28-70 days between cycles – 1 induction cycle and maximum of 2 consolidation cycles; best supportive care follows the final consolidation cycle.
1255544|NCT00071799|O3|Outcome|Low-dose Cytarabine|Cytarabine, 20 mg/m2/day subcutaneously on Days 1-14, with 28-42 days between cycles. Plus best supportive care.
1255545|NCT00071799|O2|Outcome|Best Supportive Care Only|Care can include transfusions, antibiotics, myeloid growth factors [G-CSF and GM CSF] for neutropenic infections until the end of the study.
1255546|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
1255547|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
1255548|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
1255549|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
1255550|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
1255551|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
1255552|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
1255553|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
1255554|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
1255555|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
1255556|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
1255557|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
1255558|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
1255559|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
1255560|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
1255561|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
1255562|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
1255563|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
1255564|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
1255565|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
1256570|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
1255566|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
1255567|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
1255568|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
1255569|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
1255570|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
1255571|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
1255572|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
1255573|NCT00071799|E4|Reported Event|Standard Chemotherapy|Induction cycle: Cytarabine infusion 100-200 mg/m2/day on days 1-7 + anthracycline on days 1, 2, 3 Consolidation cycle: Cytarabine infusion 100-200 mg/m2/day for 3-7 days + anthracycline on days 1 and 2 There are 28-70 days between cycles - 1 induction cycle and maximum of 2 consolidation cycles; best supportive care follows the final consolidation cycle.
1255574|NCT00071799|E3|Reported Event|Low-dose Cytarabine|Cytarabine, 20 mg/m2/day subcutaneously on Days 1-14, with 28-42 days between cycles. Plus best supportive care.
1255575|NCT00071799|E2|Reported Event|Best Supportive Care Only|Care can include transfusions, antibiotics, myeloid growth factors [G-CSF and GM CSF] for neutropenic infections until the end of the study.
1255576|NCT00071799|E1|Reported Event|Azacitidine|Azacitidine, 75 mg/m2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
1255577|NCT00071760|B1|Baseline|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255578|NCT00071760|P1|Participant Flow|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255579|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
1255580|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255581|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
1255648|NCT00071721|O1|Outcome|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
1255582|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255583|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
1255695|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255584|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255585|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
1255586|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255587|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
1255588|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255589|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255590|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255591|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255649|NCT00071721|O2|Outcome|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
1255592|NCT00071760|O3|Outcome|PI-experienced, ART-experienced FPV/RTV Treatment Group|PI- experienced, ART-experienced, HIV-1-infected pediatric participants (received ART previously, and >1 week prior PI therapy [no more than 3 PIs before study enrollment]) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent SDVs. Cohort 1: SDV 1: 30 mg/kg fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.
1255630|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255593|NCT00071760|O2|Outcome|ART-experienced, PI-naïve FPV/RTV Treatment Group|PI-naïve, ART experienced, HIV-1-infected pediatric participants (received ART previously, but received <1 week's treatment with a PI) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent single dose visits (SDV). Cohort 1: SDV 1: 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.
1255594|NCT00071760|O1|Outcome|ART-naïve FPV/RTV Treatment Group|ART-naïve Human immunodeficiency virus (HIV)-1-infected pediatric participants (received no antiretroviral agents prior to study enrollment) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent single dose visits (SDV). Cohort 1: SDV 1: 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.
1255595|NCT00071760|O3|Outcome|PI-experienced, ART-experienced FPV/RTV Treatment Group|PI- experienced, ART-experienced, HIV-1-infected pediatric participants (received ART previously, and >1 week prior PI therapy [no more than 3 PIs before study enrollment]) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent SDVs. Cohort 1: SDV 1: 30 mg/kg fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.
1255596|NCT00071760|O2|Outcome|PI-naïve, ART-experienced FPV/RTV Treatment Group|PI-naïve, ART experienced, HIV-1-infected pediatric participants (received ART previously, but received <1 week's treatment with a PI) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent single dose visits (SDV). Cohort 1: SDV 1: 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.
1255597|NCT00071760|O1|Outcome|ART-naïve FPV/RTV Treatment Group|ART-naïve Human immunodeficiency virus (HIV)-1-infected pediatric participants (received no antiretroviral agents prior to study enrollment) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent single dose visits (SDV). Cohort 1: SDV 1: 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.
1255598|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
1255650|NCT00071721|O1|Outcome|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
1255599|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255600|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
1255601|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1256571|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
1255602|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
1255603|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255604|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
1255605|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255606|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
1255607|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255608|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255609|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255930|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
1255610|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255611|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255612|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255613|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255614|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255615|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255616|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255625|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
1255617|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255618|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255631|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
1255619|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255620|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255621|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
1255622|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255623|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
1255624|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255646|NCT00071721|O1|Outcome|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
1255647|NCT00071721|O2|Outcome|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
1255626|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255627|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
1255628|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255629|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
1255946|NCT00069784|P2|Participant Flow|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
1255632|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255633|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
1255634|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255635|NCT00071760|E1|Reported Event|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
1255636|NCT00071721|B3|Baseline|Total|Total of all reporting groups
1255637|NCT00071721|B2|Baseline|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
1255638|NCT00071721|B1|Baseline|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
1255639|NCT00071721|P2|Participant Flow|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
1255640|NCT00071721|P1|Participant Flow|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
1255641|NCT00071721|O2|Outcome|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
1255642|NCT00071721|O1|Outcome|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
1255643|NCT00071721|O2|Outcome|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
1255644|NCT00071721|O1|Outcome|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
1255645|NCT00071721|O2|Outcome|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
1255651|NCT00071721|O2|Outcome|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
1255652|NCT00071721|O1|Outcome|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
1255653|NCT00071721|E2|Reported Event|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
1255654|NCT00071721|E1|Reported Event|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
1255655|NCT00071513|B3|Baseline|Total|Total of all reporting groups
1255693|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255949|NCT00069784|O1|Outcome|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
1255656|NCT00071513|B2|Baseline|Brief Intervention|"Brief Intervention: After each youth and parent completed baseline questionnaires the youth participated in a 1 on 1 standardized clinical follow-up with a trained clinician (blind to study condition) to review areas of concern, based on questionnaire responses including stressors at school, home, and with peers, level of support available and how to access support. The teen and clinician then planned a feedback call to parents, allowing teens to shape requests for support from parents as well as understand exactly what information would be shared with parents. Feedback call to parents reviewed concerns and made recommendations for services as needed. A similar procedure was followed after each assessment for all participants who indicated a risk of clinical depression or self-harm.~CAST/HSTS Preventive Intervention: Brief Intervention"
1255657|NCT00071513|B1|Baseline|CAST-T/HSTS|"HSTS condition combined the Brief Intervention and the HSTS protocol. HSTS introduced skills to enhance personal control (management of depression, anger and stress), self-esteem, decision making and interpersonal communications. Skills were taught in school based small groups to foster social support with outreach to teachers, peers, and parents. HSTS skills groups were held in the spring of 8th grade followed by four one-on-one booster sessions delivered to the students as 9th graders by HSTP leaders; parents participated in four educational sessions.~HSTS objectives are: 1) to increase the acquisition of coping skills competencies by teaching and practicing strategies taught; 2) to increase social support resources by building a supportive network; 3) to increase the youth's engagement in positive social activities; and 4) to motivate parents to increase their support via parent educational sessions.~CAST/HSTS Preventive Intervention: Brief Intervention"
1255658|NCT00071513|P2|Participant Flow|Brief Intervention|"Brief Intervention: After each youth and parent completed baseline questionnaires the youth participated in a 1 on 1 standardized clinical follow-up with a trained clinician (blind to study condition) to review areas of concern, based on questionnaire responses including stressors at school, home, and with peers, level of support available and how to access support. The teen and clinician then planned a feedback call to parents, allowing teens to shape requests for support from parents as well as understand exactly what information would be shared with parents. Feedback call to parents reviewed concerns and made recommendations for services as needed. A similar procedure was followed after each assessment for all participants who indicated a risk of clinical depression or self-harm.~CAST/HSTS Preventive Intervention: Brief Intervention"
1255659|NCT00071513|P1|Participant Flow|CAST-T/HSTS|"HSTS condition combined the Brief Intervention and the HSTS protocol. HSTS introduced skills to enhance personal control (management of depression, anger and stress), self-esteem, decision making and interpersonal communications. Skills were taught in school based small groups to foster social support with outreach to teachers, peers, and parents. HSTS skills groups were held in the spring of 8th grade followed by four one-on-one booster sessions delivered to the students as 9th graders by HSTS leaders; parents participated in four educational sessions.~HSTS objectives are: 1) to increase the acquisition of coping skills competencies by teaching and practicing strategies taught; 2) to increase social support resources by building a supportive network; 3) to increase the youth's engagement in positive social activities; and 4) to motivate parents to increase their support via parent educational sessions.~CAST/HSTS Preventive Intervention: Brief Intervention"
1255660|NCT00071513|O2|Outcome|Brief Intervention|"Brief Intervention: After each youth and parent completed baseline questionnaires the youth participated in a 1 on 1 standardized clinical follow-up with a trained clinician (blind to study condition) to review areas of concern, based on questionnaire responses including stressors at school, home, and with peers, level of support available and how to access support. The teen and clinician then planned a feedback call to parents, allowing teens to shape requests for support from parents as well as understand exactly what information would be shared with parents. Feedback call to parents reviewed concerns and made recommendations for services as needed. A similar procedure was followed after each assessment for all participants who indicated a risk of clinical depression or self-harm.~Brief Intervention: Assessment of needs and referral to services as needed."
1255661|NCT00071513|O1|Outcome|CAST-T/HSTS|"The CAST-T/HSTS condition combined the Brief Intervention and 12 school based small group sessions which taught skills to enhance personal control (to manage depression, anger, stress), self-esteem, decision making and interpersonal communications. HSTS skills groups were held in the spring of 8th grade with 4 one-on-one booster sessions delivered to the students as 9th graders by HSTP leaders; parents also participated in 4 sessions. HSTS objectives are: 1) to increase the acquisition of coping skills competencies by teaching and practicing strategies taught; 2) to increase social support resources by building a supportive network; 3) to increase the youth's engagement in positive social activities; and 4) to motivate parents to increase their support via parent educational sessions.~CAST-T/HSTS: Skills training small group."
1255681|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255682|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255683|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255684|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255662|NCT00071513|O2|Outcome|Brief Intervention|"Brief Intervention: After each youth and parent completed baseline questionnaires the youth participated in a 1 on 1 standardized clinical follow-up with a trained clinician (blind to study condition) to review areas of concern, based on questionnaire responses including stressors at school, home, and with peers, level of support available and how to access support. The teen and clinician then planned a feedback call to parents, allowing teens to shape requests for support from parents as well as understand exactly what information would be shared with parents. Feedback call to parents reviewed concerns and made recommendations for services as needed. A similar procedure was followed after each assessment for all participants who indicated a risk of clinical depression or self-harm.~CAST/HSTS Preventive Intervention: Brief Intervention"
1255663|NCT00071513|O1|Outcome|CAST-T/HSTS|"HSTS condition combined the Brief Intervention and the HSTS protocol. HSTS introduced skills to enhance personal control (management of depression, anger and stress), self-esteem, decision making and interpersonal communications. Skills were taught in school based small groups to foster social support with outreach to teachers, peers, and parents. HSTS skills groups were held in the spring of 8th grade followed by four one-on-one booster sessions delivered to the students as 9th graders by HSTP leaders; parents participated in four educational sessions.~HSTS objectives are: 1) to increase the acquisition of coping skills competencies by teaching and practicing strategies taught; 2) to increase social support resources by building a supportive network; 3) to increase the youth's engagement in positive social activities; and 4) to motivate parents to increase their support via parent educational sessions.~CAST/HSTS Preventive Intervention: Brief Intervention"
1255694|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255950|NCT00069784|O2|Outcome|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
1255664|NCT00071513|E2|Reported Event|Brief Intervention|"Brief Intervention: After each youth and parent completed baseline questionnaires the youth participated in a 1 on 1 standardized clinical follow-up with a trained clinician (blind to study condition) to review areas of concern, based on questionnaire responses including stressors at school, home, and with peers, level of support available and how to access support. The teen and clinician then planned a feedback call to parents, allowing teens to shape requests for support from parents as well as understand exactly what information would be shared with parents. Feedback call to parents reviewed concerns and made recommendations for services as needed. A similar procedure was followed after each assessment for all participants who indicated a risk of clinical depression or self-harm.~CAST/HSTS Preventive Intervention: Brief Intervention"
1255665|NCT00071513|E1|Reported Event|CAST-T/HSTS|"HSTS condition combined the Brief Intervention and the HSTS protocol. HSTS introduced skills to enhance personal control (management of depression, anger and stress), self-esteem, decision making and interpersonal communications. Skills were taught in school based small groups to foster social support with outreach to teachers, peers, and parents. HSTS skills groups were held in the spring of 8th grade followed by four one-on-one booster sessions delivered to the students as 9th graders by HSTP leaders; parents participated in four educational sessions.~HSTS objectives are: 1) to increase the acquisition of coping skills competencies by teaching and practicing strategies taught; 2) to increase social support resources by building a supportive network; 3) to increase the youth's engagement in positive social activities; and 4) to motivate parents to increase their support via parent educational sessions.~CAST/HSTS Preventive Intervention: Brief Intervention"
1255666|NCT00071487|B5|Baseline|Total|Total of all reporting groups
1255667|NCT00071487|B4|Baseline|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255668|NCT00071487|B3|Baseline|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255669|NCT00071487|B2|Baseline|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255670|NCT00071487|B1|Baseline|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255671|NCT00071487|P4|Participant Flow|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study. The 24 week-open label extension period of the study included patients who completed the 52-week double-blind period and opted to continue in the 24-week open-label period of the study and included patients who were originally randomized to the belimumab 10 mg/kg group in the double-blind period, patients who switched to belimumab 10 mg/kg at the investigator's discretion, and former placebo patients.
1255672|NCT00071487|P3|Participant Flow|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study. The 24-week open-label extension period of the study included patients who completed the 52-week double-blind period and opted to continue to receive the same dose in the 24-week open-label extension period of the study.
1255673|NCT00071487|P2|Participant Flow|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study. The 24-week open-label extension period of the study included patients who completed the 52-week double-blind period and opted to continue to receive the same dose in the 24-week open-label extension period of the study.
1255674|NCT00071487|P1|Participant Flow|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255675|NCT00071487|O5|Outcome|Open-Label Extension Period: All Active|Includes all patients who completed the 52-week double-blind period and opted to continue in a 24-week open-label extension period. Belimumab patients received the same dose or were switched to belimumab 10 mg/kg at the investigator's discretion and former placebo patients received belimumab 10 mg/kg. AE onset may be during the extension phase or continuing from the double-blind period.
1255676|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255677|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255678|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255679|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255680|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255685|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255686|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255687|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255688|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255689|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255690|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255691|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255692|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255696|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255697|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255698|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255699|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255700|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255701|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255702|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255703|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255704|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255705|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255706|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255707|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255708|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255709|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255710|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255711|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
1255712|NCT00071487|E5|Reported Event|Open-label Extension Period: All Active|Includes all patients who completed the 52-week double-blind period and opted to continue in a 24-week open-label extension period. Belimumab patients received the same dose or were switched to 10 mg/kg at investigator discretion and former placebo patients received belimumab 10 mg/kg. AE onset may be during the extension phase or continuing from the double-blind period.
1255713|NCT00071487|E4|Reported Event|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study
1255714|NCT00071487|E3|Reported Event|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study
1255715|NCT00071487|E2|Reported Event|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study
1255716|NCT00071487|E1|Reported Event|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study
1255717|NCT00071396|B1|Baseline|Campath-1H + Rituximab|"Campath 15 mg/day continuous intravenous (IV) infusion for 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course.~Rituximab 375 mg/m^2 IV infusion day 1, then 500 mg/m^2 on days 8, 15 + 22."
1255718|NCT00071396|P1|Participant Flow|Campath-1H + Rituximab|"Campath 15 mg/day continuous intravenous (IV) infusion for 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course.~Rituximab 375 mg/m^2 IV infusion day 1, then 500 mg/m^2 on days 8, 15 + 22."
1255719|NCT00071396|O1|Outcome|Campath-1H + Rituximab|"Campath 15 mg/day continuous intravenous (IV) infusion for 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course.~Rituximab 375 mg/m^2 IV infusion day 1, then 500 mg/m^2 on days 8, 15 + 22."
1255720|NCT00071396|E1|Reported Event|Campath-1H + Rituximab|"Campath 15 mg/day continuous intravenous (IV) infusion for 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course.~Rituximab 375 mg/m^2 IV infusion day 1, then 500 mg/m^2 on days 8, 15 + 22."
1255721|NCT00071110|B3|Baseline|Total|Total of all reporting groups
1255722|NCT00071110|B2|Baseline|Sham Acupuncture (SA)|Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
1255723|NCT00071110|B1|Baseline|Electroacupuncture (EA)|Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
1255724|NCT00071110|P2|Participant Flow|Sham Acupuncture (SA)|Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
1255725|NCT00071110|P1|Participant Flow|Electroacupuncture (EA)|Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
1255726|NCT00071110|O2|Outcome|Sham Acupuncture (SA)|Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
1255727|NCT00071110|O1|Outcome|Electroacupuncture (EA)|Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
1255728|NCT00071110|O2|Outcome|Sham Acupuncture (SA)|Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
1255729|NCT00071110|O1|Outcome|Electroacupuncture (EA)|Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
1255730|NCT00071110|O2|Outcome|Sham Acupuncture (SA)|Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
1255731|NCT00071110|O1|Outcome|Electroacupuncture (EA)|Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
1255732|NCT00071110|O2|Outcome|Sham Acupuncture (SA)|Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
1255733|NCT00071110|O1|Outcome|Electroacupuncture (EA)|Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
1255734|NCT00071110|E2|Reported Event|Sham Acupuncture (SA)|Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
1255735|NCT00071110|E1|Reported Event|Electroacupuncture (EA)|Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
1255736|NCT00071058|B1|Baseline|Surgery Plus Chemothrapy|"Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy.~Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m^2 continuous intravenous infusion doxorubicin over 96 hours days 1-4, 0.18 mg/m2 continuous intravenous infusion vincristine over 96 hours days 1-4, and 36 mg/m^2 continuous intravenous infusion etoposide over 96 hours days 1-4, and 150 mg tariquidar through central venous catheter over 30 minutes on days 1 and 3."
1255737|NCT00071058|P1|Participant Flow|Surgery Plus Chemotherapy|"Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy.~Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m^2 continuous intravenous infusion doxorubicin over 96 hours days 1-4, 0.18 mg/m^2 continuous intravenous infusion vincristine over 96 hours days 1-4, and 36 mg/m^2 continuous intravenous infusion etoposide over 96 hours days 1-4, and 150 mg tariquidar through central venous catheter over 30 minutes on days 1 and 3."
1255738|NCT00071058|O1|Outcome|Surgery Plus Chemotherapy|"Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy.~Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m^2 continuous intravenous infusion doxorubicin over 96 hours days 1-4, 0.18 mg/m^2 continuous intravenous infusion vincristine over 96 hours days 1-4, and 36 mg/m^2 continuous intravenous infusion etoposide over 96 hours days 1-4, and 150 mg tariquidar through central venous catheter over 30 minutes on days 1 and 3."
1255739|NCT00071058|O1|Outcome|Surgery Plus Chemotherapy|"Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy.~Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m^2 continuous intravenous infusion doxorubicin over 96 hours days 1-4, 0.18 mg/m2 continuous intravenous infusion vincristine over 96 hours days 1-4, and 36 mg/m^2 continuous intravenous infusion etoposide over 96 hours days 1-4, and 150 mg tariquidar through central venous catheter over 30 minutes on days 1 and 3."
1255740|NCT00071058|E1|Reported Event|Surgery Plus Chemothrapy|"Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy.~Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m^2 continuous intravenous infusion doxorubicin over 96 hours days 1-4, 0.18 mg/m2 continuous intravenous infusion vincristine over 96 hours days 1-4, and 36 mg/m^2 continuous intravenous infusion etoposide over 96 hours days 1-4, and 150 mg tariquidar through central venous catheter over 30 minutes on days 1 and 3."
1255741|NCT00071032|B3|Baseline|Total|Total of all reporting groups
1255742|NCT00071032|B2|Baseline|Restrictive Strategy|"Symptomatic transfusion strategy, a more conservative strategy, in which blood transfusion is withheld until the patient develops symptoms of anemia.~Restrictive (Symptomatic) Transfusion Strategy: Transfusion is withheld until the patient develops symptoms from anemia (i.e., chest pain or ECG changes thought to be ischemic, congestive heart failure, unexplained tachycardia or hypotension unresponsive to fluids) or until the hemoglobin level falls below 8 g/dL. Transfusion is permitted, but is not mandatory, if the hemoglobin level falls below 8 g/dL."
1255743|NCT00071032|B1|Baseline|Liberal (10 g/dL) Transfusion Strategy|"Transfusion strategy that maintains postoperative Hgb levels above 10 g/dL.~Liberal (10 g/dL) Transfusion Strategy: Maintains postoperative Hgb levels above 10 g/dL. This threshold strategy uses enough red blood cell units to maintain Hgb levels at or above 10 g/dL through hospital discharge or up to 30 days after randomization."
1255744|NCT00071032|P2|Participant Flow|Restrictive Strategy|Blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
1255745|NCT00071032|P1|Participant Flow|Liberal (10 g/dL) Transfusion Strategy|Transfusion strategy that maintains postoperative Hgb levels >= 10 g/dL
1255746|NCT00071032|O2|Outcome|Restrictive Strategy|Symptomatic transfusion strategy, in which blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
1255747|NCT00071032|O1|Outcome|Liberal (10 g/dL) Transfusion Strategy|Transfusion strategy that maintains postoperative Hgb levels >= 10 g/dL
1255748|NCT00071032|O2|Outcome|Restrictive Strategy|Blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
1255749|NCT00071032|O1|Outcome|Liberal (10 g/dL) Transfusion Strategy|Transfusion strategy that maintains postoperative Hgb levels >= 10 g/dL
1255750|NCT00071032|E2|Reported Event|Restrictive Strategy|Symptomatic transfusion strategy, in which blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
1255751|NCT00071032|E1|Reported Event|Liberal (10 g/dL) Transfusion Strategy|Transfusion strategy that maintains post randomization Hgb levels >= 10 g/dL
1255752|NCT00071006|B1|Baseline|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
1255753|NCT00071006|P1|Participant Flow|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
1255850|NCT00070499|O1|Outcome|Standard Dose Imatinib A|Randomization between occurred between standard dose imatinib A and high dose imatinib
1255851|NCT00070499|O4|Outcome|Standard Dose Imatinib B|Standard dose imatinib B
1255754|NCT00071006|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
1255755|NCT00071006|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
1255756|NCT00071006|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
1255757|NCT00071006|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
1255758|NCT00071006|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
1255759|NCT00071006|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
1255760|NCT00071006|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
1255761|NCT00071006|E1|Reported Event|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
1255762|NCT00070941|B4|Baseline|Total|Total of all reporting groups
1255763|NCT00070941|B3|Baseline|Placebo Comparator|oral placebo Escitalopram and placebo SAM-e
1255764|NCT00070941|B2|Baseline|Escitalopram|oral Escitalopram 10mg or 20m
1255765|NCT00070941|B1|Baseline|SAM-e|oral SAM-e, 1200mg or 2400 mg
1255766|NCT00070941|P3|Participant Flow|Placebo Comparator|oral placebo Escitalopram and placebo SAM-e
1255767|NCT00070941|P2|Participant Flow|Escitalopram|oral Escitalopram 10mg or 20m
1255768|NCT00070941|P1|Participant Flow|SAM-e|SAM-e, 1200mg or 2400 mg
1255769|NCT00070941|O3|Outcome|Placebo Comparator|oral placebo Escitalopram and placebo SAM-e
1255770|NCT00070941|O2|Outcome|Escitalopram|oral Escitalopram 10mg or 20m
1255771|NCT00070941|O1|Outcome|SAM-e|SAM-e, 1200mg or 2400 mg
1255772|NCT00070941|E3|Reported Event|Placebo|Group C/Twenty patients receiving oral placebo Escitalopram an
1255773|NCT00070941|E2|Reported Event|Oral Escitalopram|Group B/Forty patients receiving oral Escitalopram 10mg or 20m
1255774|NCT00070941|E1|Reported Event|SAM-e|Group A/Forty patients receiving oral SAM-e, 1200mg or 2400 mg
1255775|NCT00070564|B5|Baseline|Total|Total of all reporting groups
1255776|NCT00070564|B4|Baseline|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255777|NCT00070564|B3|Baseline|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255778|NCT00070564|B2|Baseline|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255779|NCT00070564|B1|Baseline|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255780|NCT00070564|P6|Participant Flow|Arm VI|"(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses."
1255781|NCT00070564|P5|Participant Flow|Arm V|"(reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses."
1255782|NCT00070564|P4|Participant Flow|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255783|NCT00070564|P3|Participant Flow|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255852|NCT00070499|O3|Outcome|Dasatinib|Dasatinib
1255784|NCT00070564|P2|Participant Flow|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255785|NCT00070564|P1|Participant Flow|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255786|NCT00070564|O4|Outcome|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255787|NCT00070564|O3|Outcome|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255788|NCT00070564|O2|Outcome|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255789|NCT00070564|O1|Outcome|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255790|NCT00070564|O4|Outcome|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255791|NCT00070564|O3|Outcome|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255792|NCT00070564|O2|Outcome|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255793|NCT00070564|O1|Outcome|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255794|NCT00070564|O4|Outcome|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255795|NCT00070564|O3|Outcome|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255796|NCT00070564|O2|Outcome|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255835|NCT00070499|O4|Outcome|Standard Dose Imatinib B|Randomization occurred between Standard dose imatinib B and dasatinib. patients received 400 mg imatinib daily
1255797|NCT00070564|O1|Outcome|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255798|NCT00070564|O4|Outcome|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255799|NCT00070564|O3|Outcome|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255853|NCT00070499|O2|Outcome|High Dose Imatinib|High dose imatinib
1255854|NCT00070499|O1|Outcome|Standard Dose Imatinib A|Standard dose imatinib A
1255800|NCT00070564|O2|Outcome|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255801|NCT00070564|O1|Outcome|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255802|NCT00070564|O4|Outcome|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255803|NCT00070564|O3|Outcome|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255804|NCT00070564|O2|Outcome|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255805|NCT00070564|O1|Outcome|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255806|NCT00070564|O4|Outcome|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255807|NCT00070564|O3|Outcome|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255808|NCT00070564|O2|Outcome|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255809|NCT00070564|O1|Outcome|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255810|NCT00070564|O4|Outcome|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255811|NCT00070564|O3|Outcome|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255812|NCT00070564|O2|Outcome|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255813|NCT00070564|O1|Outcome|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255814|NCT00070564|O4|Outcome|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255815|NCT00070564|O3|Outcome|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255855|NCT00070499|E4|Reported Event|Standard Dose Imatinib B|Randomization occurred between Standard dose imatinib B and dasatinib/ patients received 400 mg imatinib daily
1255816|NCT00070564|O2|Outcome|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255817|NCT00070564|O1|Outcome|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255818|NCT00070564|O4|Outcome|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255819|NCT00070564|O3|Outcome|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255820|NCT00070564|O2|Outcome|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255821|NCT00070564|O1|Outcome|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255822|NCT00070564|E4|Reported Event|Arm IV|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255823|NCT00070564|E3|Reported Event|Arm III|"(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255824|NCT00070564|E2|Reported Event|Arm II|"(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255825|NCT00070564|E1|Reported Event|Arm I|"(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.~pegfilgrastim: Given IV~AC regimen: Given IV~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV"
1255826|NCT00070499|B5|Baseline|Total|Total of all reporting groups
1255827|NCT00070499|B4|Baseline|Standard Dose Imatinib B|Randomization occurred between Standard dose imatinib and dasatinib
1255828|NCT00070499|B3|Baseline|Dasatinib|
1255829|NCT00070499|B2|Baseline|High Dose Imatinib|
1255830|NCT00070499|B1|Baseline|Standard Dose Imatinib A|Randomization between occurred between standard dose imatinib A and high dose imatinib
1255831|NCT00070499|P4|Participant Flow|Standard Dose Imatinib B|Randomization occurred between Standard dose imatinib and dasatinib. Standard dose imatinib was 400 mg daily.
1255832|NCT00070499|P3|Participant Flow|Dasatinib|Dasatinib dose was 100 mg daily
1255833|NCT00070499|P2|Participant Flow|High Dose Imatinib|High dose imatinib was 800 mg daily.
1255834|NCT00070499|P1|Participant Flow|Standard Dose Imatinib A|Randomization between occurred between standard dose imatinib A and high dose imatinib. Standard dose imatinib was 400 mg daily.
1255836|NCT00070499|O3|Outcome|Dasatinib|Patients received 100 mg dasatinib daily
1255838|NCT00070499|O1|Outcome|Standard Dose Imatinib A|Randomization occurred between standard dose imatinib A and high dose imatinib. patients received 400 mg imatinib daily
1255839|NCT00070499|O4|Outcome|Standard Dose Imatinib B|Randomization occurred between Standard dose imatinib and dasatinib
1255840|NCT00070499|O3|Outcome|Dasatinib|
1255841|NCT00070499|O2|Outcome|High Dose Imatinib|
1255842|NCT00070499|O1|Outcome|Standard Dose Imatinib A|Randomization between occurred between standard dose imatinib A and high dose imatinib
1255843|NCT00070499|O4|Outcome|Standard Dose Imatinib B|Randomization occurred between Standard dose imatinib and dasatinib
1255844|NCT00070499|O3|Outcome|Dasatinib|
1255845|NCT00070499|O2|Outcome|High Dose Imatinib|
1255846|NCT00070499|O1|Outcome|Standard Dose Imatinib A|Randomization between occurred between standard dose imatinib A and high dose imatinib
1255847|NCT00070499|O4|Outcome|Standard Dose Imatinib B|Randomization occurred between Standard dose imatinib and dasatinib
1255848|NCT00070499|O3|Outcome|Dasatinib|
1255849|NCT00070499|O2|Outcome|High Dose Imatinib|
1255858|NCT00070499|E1|Reported Event|Standard Dose Imatinib A|Randomization occurred between standard dose imatinib A and high dose imatinib/ patients received 400 mg imatinib daily
1255859|NCT00070291|B1|Baseline|Cyclosporine|
1255860|NCT00070291|P1|Participant Flow|Cyclosporine|"Cyclosporine doses will be based on actual body weight unless actual body weight is > 15 kg higher than the ideal body weight. Cyclosporine dose will be adjusted to maintain a trough whole blood level of 250-450 ng/mL during the high dose period (weeks 1 -6) and 150-250 ng/mL during the maintenance period (weeks 7-36) in the absence of renal toxicity.~High dose cyclosporine weeks 1-6, then maintenance dose cyclosporine weeks 7-36. If CR, PR, or SD at week 36 evaluation, treatment is complete. If progression occurs during weeks 7-36, patients will re-register to Step 2 at time of PD and begin high dose therapy (weeks 1-6), followed by maintenance therapy (weeks 7-36). At second progression patients will end protocol treatment."
1255861|NCT00070291|O1|Outcome|Cyclosporine|"Cyclosporine doses will be based on actual body weight unless actual body weight is > 15 kg higher than the ideal body weight. Cyclosporine dose will be adjusted to maintain a trough whole blood level of 250-450 ng/mL during the high dose period (weeks 1 -6) and 150-250 ng/mL during the maintenance period (weeks 7-36) in the absence of renal toxicity.~High dose cyclosporine weeks 1-6, then maintenance dose cyclosporine weeks 7-36. If CR, PR, or SD at week 36 evaluation, treatment is complete. If progression occurs during weeks 7-36, patients will re-register to Step 2 at time of PD and begin high dose therapy (weeks 1-6), followed by maintenance therapy (weeks 7-36). At second progression patients will end protocol treatment."
1255862|NCT00070291|O1|Outcome|Cyclosporine|"Cyclosporine doses will be based on actual body weight unless actual body weight is > 15 kg higher than the ideal body weight. Cyclosporine dose will be adjusted to maintain a trough whole blood level of 250-450 ng/mL during the high dose period (weeks 1 -6) and 150-250 ng/mL during the maintenance period (weeks 7-36) in the absence of renal toxicity.~High dose cyclosporine weeks 1-6, then maintenance dose cyclosporine weeks 7-36. If CR, PR, or SD at week 36 evaluation, treatment is complete. If progression occurs during weeks 7-36, patients will re-register to Step 2 at time of PD and begin high dose therapy (weeks 1-6), followed by maintenance therapy (weeks 7-36). At second progression patients will end protocol treatment."
1255863|NCT00070291|E1|Reported Event|Cyclosporine|High dose cyclosporine weeks 1-6, then maintenance dose cyclosporine weeks 7-36. If CR, PR, or SD at week 36 evaluation, treatment is complete. If progression occurs during weeks 7-36, patients will re-register to Step 2 at time of PD and begin high dose therapy (weeks 1-6), followed by maintenance therapy (weeks 7-36). At second progression patients will end protocol treatment.
1255864|NCT00070135|B1|Baseline|Treatment (Fludarabine, Busulfan, Allogeneic PBSC)|"PREPARATIVE REGIMEN: Patients receive fludarabine 30 mg/m^2 IV over 30 minutes on days -7 to -3 and busulfan 0.8 mg/kg IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3.~GVHD PROPHYLAXIS: Patients receive tacrolimus 0.03 mg/kg (suggested starting dose) PO BID on days -2 with taper between days 90-120, and stopping by days 150-180. Patients also receive methotrexate 5 mg/m^2 IV on days 1, 3, 6, and 11 and rabbit antithymocyte globulin 2.5 mg/kg IV over 4-6 hours on days -4 through -2.~ALLOGENEIC PBSC: Patients undergo allogeneic PBSC transplant on day 0. Patients then receive filgrastim 5 or 10 mcg/kg SC daily beginning on day 12 and continuing until blood counts recover."
1255865|NCT00070135|P1|Participant Flow|Treatment (Fludarabine, Busulfan, Allogeneic PBSC)|"PREPARATIVE REGIMEN: Patients receive fludarabine 30 mg/m^2 IV over 30 minutes on days -7 to -3 and busulfan 0.8 mg/kg IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3.~GVHD PROPHYLAXIS: Patients receive tacrolimus 0.03 mg/kg (suggested starting dose) PO BID on days -2 with taper between days 90-120, and stopping by days 150-180. Patients also receive methotrexate 5 mg/m^2 IV on days 1, 3, 6, and 11 and rabbit antithymocyte globulin 2.5 mg/kg IV over 4-6 hours on days -4 through -2.~ALLOGENEIC PBSC: Patients undergo allogeneic PBSC transplant on day 0. Patients then receive filgrastim 5 or 10 mcg/kg SC daily beginning on day 12 and continuing until blood counts recover."
1255866|NCT00070135|O1|Outcome|Treatment (Fludarabine, Busulfan, Allogeneic PBSC)|"PREPARATIVE REGIMEN: Patients receive fludarabine 30 mg/m^2 IV over 30 minutes on days -7 to -3 and busulfan 0.8 mg/kg IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3.~GVHD PROPHYLAXIS: Patients receive tacrolimus 0.03 mg/kg (suggested starting dose) PO BID on days -2 with taper between days 90-120, and stopping by days 150-180. Patients also receive methotrexate 5 mg/m^2 IV on days 1, 3, 6, and 11 and rabbit antithymocyte globulin 2.5 mg/kg IV over 4-6 hours on days -4 through -2.~ALLOGENEIC PBSC: Patients undergo allogeneic PBSC transplant on day 0. Patients then receive filgrastim 5 or 10 mcg/kg SC daily beginning on day 12 and continuing until blood counts recover."
1255867|NCT00070135|O1|Outcome|Treatment (Fludarabine, Busulfan, Allogeneic PBSC)|"PREPARATIVE REGIMEN: Patients receive fludarabine 30 mg/m^2 IV over 30 minutes on days -7 to -3 and busulfan 0.8 mg/kg IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3.~GVHD PROPHYLAXIS: Patients receive tacrolimus 0.03 mg/kg (suggested starting dose) PO BID on days -2 with taper between days 90-120, and stopping by days 150-180. Patients also receive methotrexate 5 mg/m^2 IV on days 1, 3, 6, and 11 and rabbit antithymocyte globulin 2.5 mg/kg IV over 4-6 hours on days -4 through -2.~ALLOGENEIC PBSC: Patients undergo allogeneic PBSC transplant on day 0. Patients then receive filgrastim 5 or 10 mcg/kg SC daily beginning on day 12 and continuing until blood counts recover."
1255931|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
1255932|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
1255868|NCT00070135|O1|Outcome|Treatment (Fludarabine, Busulfan, Allogeneic PBSC)|"PREPARATIVE REGIMEN: Patients receive fludarabine 30 mg/m^2 IV over 30 minutes on days -7 to -3 and busulfan 0.8 mg/kg IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3.~GVHD PROPHYLAXIS: Patients receive tacrolimus 0.03 mg/kg (suggested starting dose) PO BID on days -2 with taper between days 90-120, and stopping by days 150-180. Patients also receive methotrexate 5 mg/m^2 IV on days 1, 3, 6, and 11 and rabbit antithymocyte globulin 2.5 mg/kg IV over 4-6 hours on days -4 through -2.~ALLOGENEIC PBSC: Patients undergo allogeneic PBSC transplant on day 0. Patients then receive filgrastim 5 or 10 mcg/kg SC daily beginning on day 12 and continuing until blood counts recover."
1255869|NCT00070135|E1|Reported Event|Treatment (Fludarabine, Busulfan, Allogeneic PBSC)|"PREPARATIVE REGIMEN: Patients receive fludarabine 30 mg/m^2 IV over 30 minutes on days -7 to -3 and busulfan 0.8 mg/kg IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3.~GVHD PROPHYLAXIS: Patients receive tacrolimus 0.03 mg/kg (suggested starting dose) PO BID on days -2 with taper between days 90-120, and stopping by days 150-180. Patients also receive methotrexate 5 mg/m^2 IV on days 1, 3, 6, and 11 and rabbit antithymocyte globulin 2.5 mg/kg IV over 4-6 hours on days -4 through -2.~ALLOGENEIC PBSC: Patients undergo allogeneic PBSC transplant on day 0. Patients then receive filgrastim 5 or 10 mcg/kg SC daily beginning on day 12 and continuing until blood counts recover"
1255871|NCT00070109|B5|Baseline|Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
1255872|NCT00070109|B4|Baseline|Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
1255873|NCT00070109|B3|Baseline|Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
1255874|NCT00070109|B2|Baseline|Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
1255875|NCT00070109|B1|Baseline|Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV~pharmacological study: Correlative studies"
1255876|NCT00070109|P5|Participant Flow|Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
1255877|NCT00070109|P4|Participant Flow|Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
1255878|NCT00070109|P3|Participant Flow|Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
1255879|NCT00070109|P2|Participant Flow|Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Six toxicity-evaluable patients are assigned this treatment.~trabectedin: Given IV"
1255880|NCT00070109|P1|Participant Flow|Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. A cohort of 6 patients will be enrolled at the 1.3 mg/m2 dose level.~trabectedin: Given IV~pharmacological study: Correlative studies"
1255881|NCT00070109|O2|Outcome|Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Six toxicity-evaluable patients are assigned this treatment.~trabectedin: Given IV"
1255882|NCT00070109|O1|Outcome|Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV~pharmacological study: Correlative studies"
1255883|NCT00070109|O4|Outcome|Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
1255884|NCT00070109|O3|Outcome|Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
1255885|NCT00070109|O2|Outcome|Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
1255886|NCT00070109|O1|Outcome|Trabectedin 1.5 mg/m2 to Assess Feasibility|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
1255887|NCT00070109|E5|Reported Event|Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
1255888|NCT00070109|E4|Reported Event|Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
1255889|NCT00070109|E3|Reported Event|Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
1255933|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
1255890|NCT00070109|E2|Reported Event|Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
1255891|NCT00070109|E1|Reported Event|Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV~pharmacological study: Correlative studies"
1255892|NCT00070018|B1|Baseline|CHOP + RT + Zevalin|Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m^2 on day 1, doxorubicin 50 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.
1255947|NCT00069784|P1|Participant Flow|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
1255948|NCT00069784|O2|Outcome|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
1255893|NCT00070018|P1|Participant Flow|CHOP + RT + Zevalin|Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m^2 on day 1, doxorubicin 50 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.
1255894|NCT00070018|O1|Outcome|CHOP + RT + Zevalin|Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m^2 on day 1, doxorubicin 50 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.
1255895|NCT00070018|E1|Reported Event|CHOP + RT + Zevalin|Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m^2 on day 1, doxorubicin 50 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.
1255896|NCT00069953|B1|Baseline|ChemoRT and Selective Surgery|Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
1255897|NCT00069953|P1|Participant Flow|ChemoRT and Selective Surgery|Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
1255898|NCT00069953|O1|Outcome|ChemoRT and Selective Surgery|Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
1255899|NCT00069953|E1|Reported Event|ChemoRT and Selective Surgery|Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
1255900|NCT00069823|B3|Baseline|Total|Total of all reporting groups
1255901|NCT00069823|B2|Baseline|Esomeprazole|40 mg of esomeprazole twice daily
1255902|NCT00069823|B1|Baseline|Placebo|40 mg of placebo twice daily
1255903|NCT00069823|P2|Participant Flow|Esomeprazole|40 mg of esomeprazole twice daily
1255904|NCT00069823|P1|Participant Flow|Placebo|40 mg of placebo twice daily
1255905|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
1255906|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
1255907|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
1255908|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
1255909|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
1255910|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
1255911|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
1255912|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
1255913|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
1255914|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
1255915|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
1255916|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
1255917|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
1255918|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
1255919|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
1255920|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
1255921|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
1255922|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
1255923|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
1255924|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
1255925|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
1255926|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
1255927|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
1255928|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
1255929|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
1255935|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
1255936|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
1255937|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
1255938|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
1255939|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
1255940|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
1255941|NCT00069823|E2|Reported Event|Esomeprazole|40 mg of esomeprazole twice daily
1255942|NCT00069823|E1|Reported Event|Placebo|40 mg of placebo twice daily
1255943|NCT00069784|B3|Baseline|Total|Total of all reporting groups
1255944|NCT00069784|B2|Baseline|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
1255945|NCT00069784|B1|Baseline|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
1255951|NCT00069784|O1|Outcome|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
1255952|NCT00069784|O2|Outcome|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
1255953|NCT00069784|O1|Outcome|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
1255954|NCT00069784|O2|Outcome|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
1255955|NCT00069784|O1|Outcome|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
1255956|NCT00069784|O2|Outcome|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
1255957|NCT00069784|O1|Outcome|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
1255958|NCT00069784|O2|Outcome|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
1255959|NCT00069784|O1|Outcome|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
1255960|NCT00069784|O2|Outcome|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
1255961|NCT00069784|O1|Outcome|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
1255962|NCT00069784|E2|Reported Event|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
1255963|NCT00069784|E1|Reported Event|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
1255964|NCT00069641|B4|Baseline|Total|Total of all reporting groups
1255965|NCT00069641|B3|Baseline|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
1255966|NCT00069641|B2|Baseline|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
1255967|NCT00069641|B1|Baseline|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
1255968|NCT00069641|P3|Participant Flow|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
1255969|NCT00069641|P2|Participant Flow|Idursulfase Every Other Week (EOW) (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
1255970|NCT00069641|P1|Participant Flow|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 milligram per kilogram (mg/kg) administered once-weekly by intravenous infusion for one year (52 infusions).
1255971|NCT00069641|O3|Outcome|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
1255972|NCT00069641|O2|Outcome|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
1255973|NCT00069641|O1|Outcome|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
1255974|NCT00069641|O3|Outcome|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
1255975|NCT00069641|O2|Outcome|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
1255976|NCT00069641|O1|Outcome|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
1255977|NCT00069641|O2|Outcome|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
1255978|NCT00069641|O1|Outcome|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
1255979|NCT00069641|O3|Outcome|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
1255980|NCT00069641|O2|Outcome|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
1255981|NCT00069641|O1|Outcome|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
1255982|NCT00069641|O3|Outcome|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
1255983|NCT00069641|O2|Outcome|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
1255984|NCT00069641|O1|Outcome|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
1255985|NCT00069641|O3|Outcome|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
1255986|NCT00069641|O2|Outcome|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
1255987|NCT00069641|O1|Outcome|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
1255988|NCT00069641|O3|Outcome|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
1255989|NCT00069641|O2|Outcome|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
1255990|NCT00069641|O1|Outcome|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
1255991|NCT00069641|E3|Reported Event|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
1255992|NCT00069641|E2|Reported Event|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
1255993|NCT00069641|E1|Reported Event|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
1255994|NCT00069329|B1|Baseline|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
1255995|NCT00069329|P1|Participant Flow|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
1255996|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
1255997|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
1255998|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
1255999|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
1256000|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
1256001|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
1256002|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
1256003|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
1256004|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
1256005|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
1256006|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
1256007|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
1256008|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
1256009|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
1256010|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
1256011|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
1256012|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
1256013|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
1256014|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
1256015|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
1256016|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
1256017|NCT00069329|E1|Reported Event|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
1256018|NCT00069277|B1|Baseline|E7389 Dose-Escalating|E7389 dose-escalation starting at 0.25 mg/m^2 intravenous on Day 1 of a 21 day cycle. Dose escalations scheme used a two part design and proceeded based on dose-limiting toxicity and maximum tolerated dose.
1256019|NCT00069277|P1|Participant Flow|E7389 Dose-Escalating|E7389 dose-escalation starting at 0.25 mg/m^2 intravenous on Day 1 of a 21 day cycle. Dose escalations scheme used a two part design and proceeded based on dose-limiting toxicity and maximum tolerated dose.
1256941|NCT00063635|E2|Reported Event|Vitamin E|Vitamin E, 400 IU, twice daily
1256020|NCT00069277|O1|Outcome|E7389 Dose-Escalating|E7389 dose-escalation starting at 0.25 mg/m^2 intravenous on Day 1 of a 21 day cycle. Dose escalations scheme used a two part design and proceeded based on dose-limiting toxicity and maximum tolerated dose.
1256021|NCT00069277|E1|Reported Event|E7389 Dose-Escalating|E7389 dose-escalation starting at 0.25 mg/m^2 intravenous on Day 1 of a 21 day cycle. Dose escalations scheme used a two part design and proceeded based on dose-limiting toxicity and maximum tolerated dose.
1256022|NCT00069264|B1|Baseline|E7389|E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.
1256023|NCT00069264|P1|Participant Flow|E7389|E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.
1256024|NCT00069264|O1|Outcome|E7389|E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.
1256025|NCT00069264|E1|Reported Event|E7389|E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.
1256026|NCT00069238|B1|Baseline|All Participants|All participants who received at least one dose of Alemtuzumab (Campath) 30mg, 60mg, or 90mg on day 1 of therapy followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) chemotherapy intravenously every 3 weeks for up to 6 cycles.
1256027|NCT00069238|P3|Participant Flow|Alemtuzumab 90 mg|Alemtuzumab (Campath) 90mg intravenous (IV) on day 1 of therapy, followed by etoposide (50mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), prednisone (60mg/m(2) day by mouth (PO) day 0-5), vincristine (0.4mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), cyclophosphamide (750mg/m(2) day intravenous day 5), doxorubicin (10mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), (EPOCH) days 1-5 every 3 weeks for up to 6 cycles.
1256028|NCT00069238|P2|Participant Flow|Alemtuzumab 60 mg|Alemtuzumab (Campath) 60mg intravenous (IV) on day 1 of therapy, followed by etoposide (50mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), prednisone (60mg/m(2) day by mouth (PO) day 0-5), vincristine (0.4mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), cyclophosphamide (750mg/m(2) day intravenous day 5), doxorubicin (10mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), (EPOCH) days 1-5 every 3 weeks for up to 6 cycles.
1256029|NCT00069238|P1|Participant Flow|Alemtuzumab 30 mg|Alemtuzumab (Campath) 30mg intravenous (IV) on day 1 of therapy, followed by etoposide (50mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), prednisone (60mg/m(2) day by mouth (PO) day 0-5), vincristine (0.4mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), cyclophosphamide (750mg/m(2) day intravenous day 5), doxorubicin (10mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), (EPOCH) days 1-5 every 3 weeks for up to 6 cycles.
1256030|NCT00069238|O1|Outcome|All Participants|All participants who received at least one dose of Alemtuzumab (Campath) 30mg, 60mg, or 90mg on day 1 of therapy followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) chemotherapy intravenously every 3 weeks for up to 6 cycles.
1256031|NCT00069238|O1|Outcome|All Participants|All participants who received at least one dose of Alemtuzumab (Campath) 30mg, 60mg, or 90mg on day 1 of therapy followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) chemotherapy intravenously every 3 weeks for up to 6 cycles.
1256032|NCT00069238|E1|Reported Event|All Participants|"All participants who received at least one dose of Alemtuzumab (Campath) 30mg, 60mg, or 90mg on day 1 of therapy followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) chemotherapy intravenously every 3 weeks for up to 6 cycles.~The adverse events are not reported per dose level because we normally look at all adverse events together irrespective of the dose level."
1256033|NCT00069160|B3|Baseline|Total|Total of all reporting groups
1256034|NCT00069160|B2|Baseline|Pts Who Received Docetaxel on Days 1, 8, & Tariquidar Day 1,22|Patients receive docetaxel intravenous (IV) over 1 hour on days 1 and 8 and tariquidar intravenous (IV) over 30 minutes on days 1 and 22.From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose.
1256035|NCT00069160|B1|Baseline|Pts Who Received Docetaxel on Day 1, 8, & Tariquidar Day 8,22|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose.
1256036|NCT00069160|P2|Participant Flow|Pts Who Received Docetaxel on Days 1, 8, & Tariquidar Day 1,22|Patients receive docetaxel intravenous (IV) over 1 hour on days 1 and 8 and tariquidar intravenous (IV) over 30 minutes on days 1 and 22.From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose.
1256037|NCT00069160|P1|Participant Flow|Pts Who Received Docetaxel on Day 1, 8, & Tariquidar Day 8,22|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose.
1256038|NCT00069160|O1|Outcome|All Patients Who Received Docetaxel and Tariquidar|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
1256039|NCT00069160|O1|Outcome|All Patients Who Received Docetaxel and Tariquidar|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
1256040|NCT00069160|O1|Outcome|All Patients Who Received Docetaxel and Tariquidar|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
1256041|NCT00069160|O2|Outcome|With Tariquidar|40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on either day 1 or 8 and then again on day 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose of tariquidar.
1256042|NCT00069160|O1|Outcome|Docetaxel Alone|40 mg/m^2 docetaxel over 1 hour on days 1 and 8.
1256307|NCT00067470|O2|Outcome|Placebo|Intravenous (IV) placebo solution at a volume equivalent to that needed for a 1.0 mg/kg dose of rhASB
1256308|NCT00067470|O1|Outcome|rhASB|Intravenous (IV) recombinant human arylsulfatase(rhASB) at 1.0 mg/kg
1256043|NCT00069160|O2|Outcome|Patients on Docetaxel on Days 1, 8 & Tariquidar on Days 1, 22|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
1256044|NCT00069160|O1|Outcome|Patients on Docetaxel on Days 1, 8 & Tariquidar on Day 8, 22|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
1256045|NCT00069160|O2|Outcome|With Tariquidar|40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on either day 1 or 8 and then again on day 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose of tariquidar.
1256046|NCT00069160|O1|Outcome|Docetaxel Alone|40 mg/m^2 docetaxel over 1 hour on days 1 and 8.
1256212|NCT00068588|B3|Baseline|Arm 3|Capecitabine 1250 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
1256047|NCT00069160|E2|Reported Event|Patients on Docetaxel on Days 1, 8 & Tariquidar on Days 1, 22|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
1256048|NCT00069160|E1|Reported Event|Patients on Docetaxel on Days 1, 8 & Tariquidar on Day 8, 22|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
1256049|NCT00069121|B3|Baseline|Total|Total of all reporting groups
1256050|NCT00069121|B2|Baseline|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
1256051|NCT00069121|B1|Baseline|5-FU/LV|"Given by one of two regimens.~Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or~Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)"
1256052|NCT00069121|P2|Participant Flow|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
1256053|NCT00069121|P1|Participant Flow|5-FU/LV|"Given by one of two regimens.~Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or~Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)"
1256054|NCT00069121|O3|Outcome|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
1256055|NCT00069121|O2|Outcome|5-FU/LV ROSWELL PARK|Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)
1256056|NCT00069121|O1|Outcome|5-FU/LV MAYO CLINIC|Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks)
1256057|NCT00069121|O2|Outcome|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
1256058|NCT00069121|O1|Outcome|5-FU/LV|"Given by one of two regimens.~Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or~Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)"
1256059|NCT00069121|O2|Outcome|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
1256060|NCT00069121|O1|Outcome|5-FU/LV|"Given by one of two regimens.~Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or~Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)"
1256061|NCT00069121|O2|Outcome|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
1256213|NCT00068588|B2|Baseline|Arm 2|Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
1256062|NCT00069121|O1|Outcome|5-FU/LV|"Given by one of two regimens.~Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or~Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)"
1256063|NCT00069121|O2|Outcome|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
1256064|NCT00069121|O1|Outcome|5-FU/LV|"Given by one of two regimens.~Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or~Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)"
1256065|NCT00069121|O2|Outcome|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
1256066|NCT00069121|O1|Outcome|5-FU/LV|"Given by one of two regimens.~Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or~Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)"
1256067|NCT00069121|O2|Outcome|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
1256068|NCT00069121|O1|Outcome|5-FU/LV|"Given by one of two regimens.~Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or~Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)"
1256069|NCT00069121|E3|Reported Event|XELOX|Capecitabine in Combination with Intravenous Oxaliplatin (Q3W)
1256070|NCT00069121|E2|Reported Event|5-FU/LV ROSWELL PARK|5-fluorouracil/leucovorin
1256071|NCT00069121|E1|Reported Event|5-FU/LV MAYO CLINIC|5-fluorouracil/leucovorin
1256072|NCT00069108|B3|Baseline|Total|Total of all reporting groups
1256073|NCT00069108|B2|Baseline|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
1256074|NCT00069108|B1|Baseline|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 IV infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
1256199|NCT00068601|B2|Baseline|Arm 2|"Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.~cyclophosphamide: Part of planned chemotherapy regimen~goserelin acetate: Given subcutaneously"
1256200|NCT00068601|B1|Baseline|Arm 1|"Patients receive cyclophosphamide-containing chemotherapy alone.~cyclophosphamide: Part of planned chemotherapy regimen"
1256075|NCT00069108|P2|Participant Flow|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
1256076|NCT00069108|P1|Participant Flow|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
1256178|NCT00068770|B2|Baseline|nonp450 (-EIASD)|not on p450 inhibitor (Patients either NOT taking anti-seizure drugs or ones that are known to not significantly influence the hepatic drug-metabolizing enzymes - including gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine,topiramate, zonisamide and filbamate.
1256179|NCT00068770|B1|Baseline|p450 ( +EIASD)|on p450 inhibitor (Patients taking anttiseizure drugs that are known to induce the hepatic drug-metabolizing enzymes - including phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine)
1256077|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m^2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
1256078|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
1256079|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
1256080|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
1256081|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
1256082|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
1256083|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
1256084|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
1256201|NCT00068601|P2|Participant Flow|Chemotherapy Plus Goserelin|"Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.~cyclophosphamide: Part of planned chemotherapy regimen~goserelin acetate: Given subcutaneously"
1256085|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
1256086|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
1256087|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
1256180|NCT00068770|P2|Participant Flow|p450|"on p450 inhibitor~celecoxib :~radiation therapy :"
1256181|NCT00068770|P1|Participant Flow|nonp450|"not on p450 inhibitor~celecoxib :~radiation therapy :"
1256572|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
1256088|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
1256089|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
1256090|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
1256091|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
1256092|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
1256093|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
1256094|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
1256095|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
1256096|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
1256097|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
1256098|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
1256214|NCT00068588|B1|Baseline|Arm 1|Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
1256325|NCT00066963|P2|Participant Flow|Experimental: FV Every 12mo for 24mo + Counsel|Preventive fluoride varnish every 12mo for 24mo plus Counseling (2FV)
1256099|NCT00069108|E2|Reported Event|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m^2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
1256100|NCT00069108|E1|Reported Event|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
1256101|NCT00069095|B7|Baseline|Total|Total of all reporting groups
1256102|NCT00069095|B6|Baseline|Folfox-4+BV|Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 5 mg/kg over 30 to 90 minutes followed by oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
1256103|NCT00069095|B5|Baseline|Xelox+BV|Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 7.5 mg/kg over 30 to 90 minutes followed by oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
1256104|NCT00069095|B4|Baseline|Folfox-4+P|Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for BV (volume equivalent to 5 mg/kg BV) over 30 to 90 minutes followed by oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
1256112|NCT00069095|P2|Participant Flow|Folfox-4|Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
1256105|NCT00069095|B3|Baseline|Xelox+P|Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for bevacizumab (BV) [volume equivalent to 7.5 mg/kg BV] over 30 to 90 minutes followed by oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
1256106|NCT00069095|B2|Baseline|Folfox-4|Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
1256107|NCT00069095|B1|Baseline|Xelox|Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
1256215|NCT00068588|P3|Participant Flow|Arm 3|Capecitabine 1250 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
1256326|NCT00066963|P1|Participant Flow|No Intervention: Counseling Only|Counseling Only (0FV)
1256108|NCT00069095|P6|Participant Flow|Folfox-4+BV|Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 5 mg/kg over 30 to 90 minutes followed by oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
1256109|NCT00069095|P5|Participant Flow|Xelox+BV|Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 7.5 mg/kg over 30 to 90 minutes followed by oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
1256110|NCT00069095|P4|Participant Flow|Folfox-4+P|Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for BV (volume equivalent to 5 mg/kg BV) over 30 to 90 minutes followed by oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
1256111|NCT00069095|P3|Participant Flow|Xelox+P|Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for bevacizumab (BV) [volume equivalent to 7.5 mg/kg BV] over 30 to 90 minutes followed by oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
1256202|NCT00068601|P1|Participant Flow|Standard Chemotherapy|"Patients receive cyclophosphamide-containing chemotherapy alone.~cyclophosphamide: Part of planned chemotherapy regimen"
1256309|NCT00067470|E2|Reported Event|Placebo|Intravenous (IV) placebo solution at a volume equivalent to that needed for a 1.0 mg/kg dose of rhASB
1256113|NCT00069095|P1|Participant Flow|Xelox|Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
1256114|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
1256115|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
1256216|NCT00068588|P2|Participant Flow|Arm 2|Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
1256327|NCT00066963|O3|Outcome|FV 2x/Year + Counseling|fluoride varnish (FV) (5% NaF, Duraphat®, Colgate) twice per year for 2 years (every 6 months)
1256116|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
1256117|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
1256118|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
1256119|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
1256120|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
1256203|NCT00068601|O2|Outcome|Chemotherapy Plus Goserelin|"Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.~cyclophosphamide: Part of planned chemotherapy regimen~goserelin acetate: Given subcutaneously"
1256204|NCT00068601|O1|Outcome|Standard Chemotherapy|"Patients receive cyclophosphamide-containing chemotherapy alone.~cyclophosphamide: Part of planned chemotherapy regimen"
1256121|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
1256122|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
1256123|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
1256182|NCT00068770|O2|Outcome|nonp450 (-EIASD)|"not on p450 inhibitor (Patients either NOT taking anti-seizure drugs or ones that are known to not significantly influence the hepatic drug-metabolizing enzymes - including gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine,topiramate, zonisamide and filbamate.~latest survial data was obtained on May 30, 2006. 31/35 pts had died (89%) 21 in the +EIASD group and 10 in -EIASD group"
1256183|NCT00068770|O1|Outcome|p450 ( +EIASD)|"on p450 inhibitor (Patients taking anttiseizure drugs that are known to induce the hepatic drug-metabolizing enzymes - including phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine)~latest survial data was obtained on May 30, 2006. 31/35 pts had died (89%) 21 in the +EIASD group and 10 in -EIASD group"
1256124|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
1256125|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
1256126|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
1256127|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
1256128|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
1256129|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
1256130|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
1256131|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
1256132|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
1256184|NCT00068770|O2|Outcome|p450|"on p450 inhibitor~celecoxib :~radiation therapy :"
1256133|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
1256134|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
1256135|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
1256136|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
1256137|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
1256260|NCT00068341|O2|Outcome|Arm II:Her2+|all evaluated subjects.
1256138|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
1256139|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
1256140|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
1256141|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
1256185|NCT00068770|O1|Outcome|nonp450|"not on p450 inhibitor~celecoxib :~radiation therapy :"
1256186|NCT00068770|E2|Reported Event|Non P450 ARM|NOT on p450 inhibitor *non P450 ARM (Patients either NOT taking anti-seizure drugs or ones that are known to not significantly influence the hepatic drug-metabolizing enzymes - including gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine,topiramate, zonisamide and filbamate, Keppra.
1256187|NCT00068770|E1|Reported Event|P450 ARM|on p450 inhibitor (Patients taking anttiseizure drugs that are known to induce the hepatic drug-metabolizing enzymes - including phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine)
1256142|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
1256143|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
1256144|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
1256145|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
1256155|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
1256146|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
1256147|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
1256148|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
1256149|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
1256150|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
1256321|NCT00066963|B3|Baseline|Experimental: FV Every 6mo for 24mo + Counsel|Preventive fluoride varnish every 6mo for 24mo plus Counseling (4FV)
1256151|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
1256152|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
1256153|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
1256154|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
1256156|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
1256157|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
1256158|NCT00069095|E6|Reported Event|Folfox-4+BV|Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 5 mg/kg over 30 to 90 minutes followed by oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
1256188|NCT00068718|B1|Baseline|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.~Therapeutic Allogeneic Lymphocytes: Given IV"
1256322|NCT00066963|B2|Baseline|Experimental: FV Every 12mo for 24mo + Counsel|Preventive fluoride varnish every 12mo for 24mo plus Counseling (2FV)
1256159|NCT00069095|E5|Reported Event|Xelox+BV|Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 7.5 mg/kg over 30 to 90 minutes followed by oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
1256160|NCT00069095|E4|Reported Event|Folfox-4+P|Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for BV (volume equivalent to 5 mg/kg BV) over 30 to 90 minutes followed by oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
1256161|NCT00069095|E3|Reported Event|Xelox+P|Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for bevacizumab (BV) [volume equivalent to 7.5 mg/kg BV] over 30 to 90 minutes followed by oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
1256162|NCT00069095|E2|Reported Event|Folfox-4|Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
1256261|NCT00068341|O1|Outcome|Arm I: Her2+|all evaluated subjects.
1256262|NCT00068341|O4|Outcome|Total|
1256263|NCT00068341|O3|Outcome|HER2-|(Pre-Op TC)
1256264|NCT00068341|O2|Outcome|Arm II: HER2+|(Pre-Op TC, Post-Op Herceptin)
1256163|NCT00069095|E1|Reported Event|Xelox|Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
1256164|NCT00068822|B3|Baseline|Total|Total of all reporting groups
1256165|NCT00068822|B2|Baseline|Control Group|Participants will receive partial vertebroplasty without PMMA
1256166|NCT00068822|B1|Baseline|Vertebroplasty|Participants will receive percutaneous vertebroplasty
1256167|NCT00068822|P2|Participant Flow|Control, Then Vertebroplasty|Participants randomized to receive Control procedure, Sham Vertebroplasty first (Partial vertebroplasty without PMMA in which participants were given verbal and physical cues such as pressure on the back, following local anesthesia with lidocaine and bupivacaine, but the needle was not placed.) At Month 1 or Month 3 if participants did not get enough pain relief from the procedure, they could opt to crossover to the alternative percutaneous vertebroplasty (placement of polymethylmethacrylate [PMMA] into vertebral compression fracture).
1256168|NCT00068822|P1|Participant Flow|Vertebroplasty, Then Control|Participants randomized to receive percutaneous vertebroplasty first (placement of polymethylmethacrylate [PMMA] into vertebral compression fracture). At Month 1 or Month 3 if participants did not get enough pain relief from the procedure, they could opt to crossover to the alternative Control procedure, Sham Vertebroplasty (partial vertebroplasty without PMMA in which participants were given verbal and physical cues such as pressure on the back, following local anesthesia with lidocaine and bupivacaine, but the needle was not placed.)
1256169|NCT00068822|O2|Outcome|Control Group|Participants will receive partial vertebroplasty without PMMA
1256170|NCT00068822|O1|Outcome|Vertebroplasty|Participants will receive percutaneous vertebroplasty
1256171|NCT00068822|O2|Outcome|Control Group|Participants will receive partial vertebroplasty without PMMA
1256172|NCT00068822|O1|Outcome|Vertebroplasty|Participants will receive percutaneous vertebroplasty
1256173|NCT00068822|O2|Outcome|Control Group|Participants will receive partial vertebroplasty without PMMA
1256174|NCT00068822|O1|Outcome|Vertebroplasty|Participants will receive percutaneous vertebroplasty
1256175|NCT00068822|E2|Reported Event|Control Group|Participants will receive partial vertebroplasty without PMMA
1256176|NCT00068822|E1|Reported Event|Vertebroplasty|Participants will receive percutaneous vertebroplasty
1256177|NCT00068770|B3|Baseline|Total|Total of all reporting groups
1256323|NCT00066963|B1|Baseline|No Intervention: Counseling Only|Counseling Only (0FV)
1256189|NCT00068718|P1|Participant Flow|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.~Therapeutic Allogeneic Lymphocytes: Given IV"
1256190|NCT00068718|O1|Outcome|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.~Therapeutic Allogeneic Lymphocytes: Given IV"
1256191|NCT00068718|O1|Outcome|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.~Therapeutic Allogeneic Lymphocytes: Given IV"
1256192|NCT00068718|O1|Outcome|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.~Therapeutic Allogeneic Lymphocytes: Given IV"
1256193|NCT00068718|O1|Outcome|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.~Therapeutic Allogeneic Lymphocytes: Given IV"
1256194|NCT00068718|O1|Outcome|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.~Therapeutic Allogeneic Lymphocytes: Given IV"
1256195|NCT00068718|O1|Outcome|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.~Therapeutic Allogeneic Lymphocytes: Given IV"
1256196|NCT00068718|O1|Outcome|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.~Therapeutic Allogeneic Lymphocytes: Given IV"
1256197|NCT00068718|E1|Reported Event|Treatment (DLI)|"Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.~Therapeutic Allogeneic Lymphocytes: Given IV"
1256198|NCT00068601|B3|Baseline|Total|Total of all reporting groups
1256265|NCT00068341|O1|Outcome|Arm I: HER2+|(Pre-Op TCH)
1256205|NCT00068601|O2|Outcome|Chemotherapy Plus Goserelin|"Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.~cyclophosphamide: Part of planned chemotherapy regimen~goserelin acetate: Given subcutaneously"
1256206|NCT00068601|O1|Outcome|Standard Chemotherapy|"Patients receive cyclophosphamide-containing chemotherapy alone.~cyclophosphamide: Part of planned chemotherapy regimen"
1256207|NCT00068601|O2|Outcome|Chemotherapy Plus Goserelin|"Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.~cyclophosphamide: Part of planned chemotherapy regimen~goserelin acetate: Given subcutaneously"
1256208|NCT00068601|O1|Outcome|Standard Chemotherapy|"Patients receive cyclophosphamide-containing chemotherapy alone.~cyclophosphamide: Part of planned chemotherapy regimen"
1256209|NCT00068601|E2|Reported Event|Chemotherapy Plus Goserelin|Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity. cyclophosphamide: Part of planned chemotherapy regimen. goserelin acetate: Given subcutaneously
1256210|NCT00068601|E1|Reported Event|Standard Chemotherapy|Patients receive cyclophosphamide-containing chemotherapy alone. cyclophosphamide: Part of planned chemotherapy regimen
1256211|NCT00068588|B4|Baseline|Total|Total of all reporting groups
1256549|NCT00065507|P1|Participant Flow|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
1256217|NCT00068588|P1|Participant Flow|Arm 1|Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
1256218|NCT00068588|O3|Outcome|Arm 3|Capecitabine 1250 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
1256219|NCT00068588|O2|Outcome|Arm 2|Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
1256220|NCT00068588|O1|Outcome|Arm 1|Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
1256221|NCT00068588|O3|Outcome|Arm 3|Capecitabine 1250 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
1256222|NCT00068588|O2|Outcome|Arm 2|Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
1256223|NCT00068588|O1|Outcome|Arm 1|Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
1256224|NCT00068588|E2|Reported Event|Arm 3|Capecitabine 1250 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
1256225|NCT00068588|E1|Reported Event|Arm 2|Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
1256226|NCT00068575|B1|Baseline|Postoperative Chemoradiation Regimen|Postoperative Cisplatin 30 mg/m^2 intravenous (IV) weekly for 6 doses, Interferon Alfa-2b 3 million units subcutaneous (SQ) on Monday, Wednesday and Friday days 1-19 and 29-45 for 17 total doses, and 5-fluorouracil (5-FU) 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment.
1256227|NCT00068575|P1|Participant Flow|Postoperative Chemoradiation Regimen|Postoperative Cisplatin 30 mg/m^2 intravenous (IV) weekly for 6 doses, Interferon Alfa-2b 3 million units subcutaneous (SQ) on Monday, Wednesday and Friday days 1-19 and 29-45 for 17 total doses, and 5-fluorouracil (5-FU) 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment.
1256228|NCT00068575|O1|Outcome|Postoperative Chemoradiation Regimen|Postoperative Cisplatin 30 mg/m^2 intravenous (IV) weekly for 6 doses, Interferon Alfa-2b 3 million units subcutaneous (SQ) on Monday, Wednesday and Friday days 1-19 and 29-45 for 17 total doses, and 5-fluorouracil (5-FU) 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment.
1256229|NCT00068575|E1|Reported Event|Postoperative Chemoradiation Regimen|Postoperative Cisplatin 30 mg/m^2 intravenous (IV) weekly for 6 doses, Interferon Alfa-2b 3 million units subcutaneous (SQ) on Monday, Wednesday and Friday days 1-19 and 29-45 for 17 total doses, and 5-fluorouracil (5-FU) 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment.
1256230|NCT00068419|B1|Baseline|Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)|Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
1256231|NCT00068419|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)|Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
1256232|NCT00068419|O1|Outcome|Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)|Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
1256233|NCT00068419|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)|Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
1256266|NCT00068341|E4|Reported Event|Total|
1256267|NCT00068341|E3|Reported Event|Arm III: HER2- (Pre-Op TC)|HER2/neu negative patients carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV
1256234|NCT00068393|B1|Baseline|Doxorubicin/Gemcitabine|"Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks.~Only eligible and treated patients are included in the analysis."
1256235|NCT00068393|P1|Participant Flow|Doxorubicin/Gemcitabine|"Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks.~Only eligible and treated patients are included in the analysis."
1256236|NCT00068393|O1|Outcome|Doxorubicin/Gemcitabine|"Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks.~Only eligible and treated patients are included in the analysis."
1256237|NCT00068393|O1|Outcome|Doxorubicin/Gemcitabine|"Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks.~Only eligible and treated patients are included in the analysis."
1256238|NCT00068393|O1|Outcome|Doxorubicin/Gemcitabine|"Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks.~Only eligible and treated patients are included in the analysis."
1256239|NCT00068393|E1|Reported Event|Doxorubicin/Gemcitabine|"Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks.~Only eligible and treated patients are included in the analysis."
1256240|NCT00068380|B1|Baseline|Treatment (Imatinib Mesylate)|"Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
1256241|NCT00068380|P1|Participant Flow|Treatment (Imatinib Mesylate)|"Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
1256242|NCT00068380|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
1256243|NCT00068380|E1|Reported Event|Treatment (Imatinib Mesylate)|"Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
1256244|NCT00068341|B4|Baseline|Total|Total of all reporting groups
1256245|NCT00068341|B3|Baseline|HER2/Neu Negative Patients|"please see intervention description~carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV~docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV"
1256246|NCT00068341|B2|Baseline|Arm II (Neoadjuvant Therapy)|"please see intervention description~trastuzumab: Cycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV~carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV~docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV"
1256247|NCT00068341|B1|Baseline|Arm I (Neoadjuvant Therapy)|"see intervention description~carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV~docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV~trastuzumab: Cycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV~Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV~Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV"
1256248|NCT00068341|P3|Participant Flow|HER2/Neu Negative Patients|"please see intervention description~carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV~docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV"
1256249|NCT00068341|P2|Participant Flow|Arm II (Neoadjuvant Therapy)|"please see intervention description~trastuzumab: Cycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV~carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV~docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV"
1256250|NCT00068341|P1|Participant Flow|Arm I (Neoadjuvant Therapy)|"see intervention description~carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV (AUC = area under the curve, total drug exposure over time)~docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV~trastuzumab: Cycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV~Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV~Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV"
1256251|NCT00068341|O3|Outcome|Her2- (Pre-op TC)|enrolled subjects
1256252|NCT00068341|O2|Outcome|Her2+ (Pre-op TC, Post-op Herceptin)|enrolled subjects
1256253|NCT00068341|O1|Outcome|Arm I (Pre-op TCH)|enrolled subjects
1256254|NCT00068341|O2|Outcome|Pathologic CR - No|All enrolled subjects
1256255|NCT00068341|O1|Outcome|Pathologic CR - Yes|All enrolled subjects
1256256|NCT00068341|O3|Outcome|Arm III: Her -|all enrolled subjects
1256257|NCT00068341|O2|Outcome|Arm II: Her2 +|all enrolled subjects
1256258|NCT00068341|O1|Outcome|Arm I: Her2 +|all enrolled subjects
1256259|NCT00068341|O3|Outcome|Arm III: Her2-|all evaluated subjects.
1256268|NCT00068341|E2|Reported Event|Arm II: HER2+ (Pre-Op TC, Post-Op Herceptin)|Arm II trastuzumab: Cycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV
1256269|NCT00068341|E1|Reported Event|Arm I: HER+ (Pre-Op TCH)|Arm I carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV trastuzumab: Cycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV
1256270|NCT00068237|B1|Baseline|Surgery and Salivary Gland Transfer and Radiation|Patients undergo surgery for the primary and neck nodes and submandibular salivary gland transfer on Day 1 followed by post-operative radiation therapy within 4-6 weeks of surgery. Radiation therapy dose can range from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction.
1256271|NCT00068237|P1|Participant Flow|Surgery and Salivary Gland Transfer and Radiation|Patients undergo surgery for the primary and neck nodes and submandibular salivary gland transfer on Day 1 followed by post-operative radiation therapy within 4-6 weeks of surgery. Radiation therapy dose can range from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction.
1256324|NCT00066963|P3|Participant Flow|Experimental: FV Every 6mo for 24mo + Counsel|Preventive fluoride varnish every 6mo for 24mo plus Counseling (4FV)
1256550|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
1256272|NCT00068237|O1|Outcome|Surgery and Salivary Gland Transfer and Radiation|Patients undergo surgery for the primary and neck nodes and submandibular salivary gland transfer on Day 1 followed by post-operative radiation therapy within 4-6 weeks of surgery. Radiation therapy dose can range from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction.
1256273|NCT00068237|E1|Reported Event|Surgery and Salivary Gland Transfer and Radiation|Patients undergo surgery for the primary and neck nodes and submandibular salivary gland transfer on Day 1 followed by post-operative radiation therapy within 4-6 weeks of surgery. Radiation therapy dose can range from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction.
1256274|NCT00068107|B1|Baseline|All Participants|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month.
1256275|NCT00068107|P1|Participant Flow|All Participants|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month. Patients will receive a dose of 0.2 mg/kg of body weight every week.
1256276|NCT00068107|O1|Outcome|All Participants|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month.
1256277|NCT00068107|O1|Outcome|All Participants|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month. Patients will receive a dose of 0.2 mg/kg of body weight every week.
1256278|NCT00068107|O1|Outcome|All Participants|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month.
1256279|NCT00068107|O2|Outcome|All Participants at Last Observation|
1256280|NCT00068107|O1|Outcome|All Participants at Baseline|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month.
1256281|NCT00068107|O2|Outcome|All Participants at Last Observation|
1256282|NCT00068107|O1|Outcome|All Participants at Baseline|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month.
1256283|NCT00068107|O1|Outcome|All Participants|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month.
1256284|NCT00068107|E1|Reported Event|All Participants|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month.
1256285|NCT00067808|B4|Baseline|Total|Total of all reporting groups
1256286|NCT00067808|B3|Baseline|Decitabine 20 mg/m2 SQ|20 mg/m2 subcutaneous (SQ) daily for 5 days
1256287|NCT00067808|B2|Baseline|Decitabine 20 mg/m2 IV|20 mg/m2 IV over 1 hour daily for 5 days
1256288|NCT00067808|B1|Baseline|Decitabine 10 mg/m2 IV|10 mg/m2 by vein (IV) over 1 hour daily for 10 days
1256289|NCT00067808|P3|Participant Flow|Decitabine 20 mg/m2 SQ|20 mg/m2 subcutaneous (SQ) daily for 5 days
1256290|NCT00067808|P2|Participant Flow|Decitabine 20 mg/m2 IV|20 mg/m2 IV over 1 hour daily for 5 days
1256291|NCT00067808|P1|Participant Flow|Decitabine 10 mg/m2 IV|10 mg/m2 by vein (IV) over 1 hour daily for 10 days
1256292|NCT00067808|O3|Outcome|Decitabine 20 mg/m2 SQ|20 mg/m2 subcutaneous (SQ) daily for 5 days
1256293|NCT00067808|O2|Outcome|Decitabine 20 mg/m2 IV|20 mg/m2 IV over 1 hour daily for 5 days
1256294|NCT00067808|O1|Outcome|Decitabine 10 mg/m2 IV|10 mg/m2 by vein (IV) over 1 hour daily for 10 days
1256295|NCT00067808|E3|Reported Event|Decitabine 20 mg/m2 SQ|20 mg/m2 subcutaneous (SQ) daily for 5 days
1256296|NCT00067808|E2|Reported Event|Decitabine 20 mg/m2 IV|20 mg/m2 IV over 1 hour daily for 5 days
1256297|NCT00067808|E1|Reported Event|Decitabine 10 mg/m2 IV|10 mg/m2 by vein (IV) over 1 hour daily for 10 days
1256298|NCT00067470|B3|Baseline|Total|Total of all reporting groups
1256299|NCT00067470|B2|Baseline|Placebo|Intravenous (IV) placebo solution at a volume equivalent to that needed for a 1.0 mg/kg dose of rhASB
1256300|NCT00067470|B1|Baseline|rhASB|Intravenous (IV) recombinant human arylsulfatase(rhASB) at 1.0 mg/kg
1256301|NCT00067470|P2|Participant Flow|Placebo|Intravenous (IV) placebo solution at a volume equivalent to that needed for a 1.0 mg/kg dose of rhASB
1256302|NCT00067470|P1|Participant Flow|rhASB|Intravenous (IV) recombinant human arylsulfatase(rhASB) at 1.0 mg/kg
1256303|NCT00067470|O2|Outcome|Placebo|Intravenous (IV) placebo solution at a volume equivalent to that needed for a 1.0 mg/kg dose of rhASB
1256304|NCT00067470|O1|Outcome|rhASB|Intravenous (IV) recombinant human arylsulfatase(rhASB) at 1.0 mg/kg
1256305|NCT00067470|O2|Outcome|Placebo|Intravenous (IV) placebo solution at a volume equivalent to that needed for a 1.0 mg/kg dose of rhASB
1256306|NCT00067470|O1|Outcome|rhASB|Intravenous (IV) recombinant human arylsulfatase(rhASB) at 1.0 mg/kg
1256310|NCT00067470|E1|Reported Event|rhASB|Intravenous (IV) recombinant human arylsulfatase(rhASB) at 1.0 mg/kg
1256311|NCT00067236|B3|Baseline|Total|Total of all reporting groups
1256312|NCT00067236|B2|Baseline|PG-116800 Tablet|PG-116800 tablet (200 mg) twice daily for 90 days
1256313|NCT00067236|B1|Baseline|Placebo|Placebo tablet twice daily for 90 days
1256314|NCT00067236|P2|Participant Flow|PG-116800 Tablet|PG-116800 tablet (200 mg) twice daily for 90 days
1256315|NCT00067236|P1|Participant Flow|Placebo|Placebo tablet twice daily for 90 days
1256316|NCT00067236|O2|Outcome|PG-116800 Tablet|PG-116800 tablet (200 mg) twice daily for 90 days
1256317|NCT00067236|O1|Outcome|Placebo|Placebo tablet twice daily for 90 days
1256318|NCT00067236|E2|Reported Event|PG-116800 Tablet|PG-116800 tablet (200 mg) twice daily for 90 days
1256319|NCT00067236|E1|Reported Event|Placebo|Placebo tablet twice daily for 90 days
1256320|NCT00066963|B4|Baseline|Total|Total of all reporting groups
1256328|NCT00066963|O2|Outcome|FV 1x/Year + Counseling|fluoride varnish (FV) (5% NaF, Duraphat®, Colgate) once per year for 2 years (every 12 months) plus caregiver counseling
1256329|NCT00066963|O1|Outcome|Counseling Only|caregiver counseling only (zero fluoride varnish)
1256330|NCT00066963|E3|Reported Event|Experimental: FV Every 6mo for 24mo + Counsel|Preventive fluoride varnish every 6mo for 24mo plus Counseling (4FV)
1256331|NCT00066963|E2|Reported Event|Experimental: FV Every 12mo for 24mo + Counsel|Preventive fluoride varnish every 12mo for 24mo plus Counseling (2FV)
1256332|NCT00066963|E1|Reported Event|No Intervention: Counseling Only|Counseling Only (0FV)
1256333|NCT00066807|B3|Baseline|Total|Total of all reporting groups
1256334|NCT00066807|B2|Baseline|Chemotherapy Plus OFS Plus T or E for 5 Years|Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
1256335|NCT00066807|B1|Baseline|OFS Plus T or E for 5 Years|Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
1256336|NCT00066807|P2|Participant Flow|Chemotherapy Plus OFS Plus T or E for 5 Years|Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
1256337|NCT00066807|P1|Participant Flow|OFS Plus T or E for 5 Years|Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
1256338|NCT00066807|O2|Outcome|Chemotherapy Plus OFS Plus T or E for 5 Years|Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
1256339|NCT00066807|O1|Outcome|OFS Plus T or E for 5 Years|Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
1256340|NCT00066807|O2|Outcome|Chemotherapy Plus OFS Plus T or E for 5 Years|Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
1256341|NCT00066807|O1|Outcome|OFS Plus T or E for 5 Years|Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
1256342|NCT00066807|O2|Outcome|Chemotherapy Plus OFS Plus T or E for 5 Years|Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
1256343|NCT00066807|O1|Outcome|OFS Plus T or E for 5 Years|Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
1256344|NCT00066807|O2|Outcome|Chemotherapy Plus OFS Plus T or E for 5 Years|Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
1256345|NCT00066807|O1|Outcome|OFS Plus T or E for 5 Years|Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
1256346|NCT00066807|E2|Reported Event|Chemotherapy Plus OFS Plus T or E for 5 Years|Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
1256347|NCT00066807|E1|Reported Event|OFS Plus T or E for 5 Years|Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
1256348|NCT00066781|B3|Baseline|Total|Total of all reporting groups
1256349|NCT00066781|B2|Baseline|Cohort II|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
1256350|NCT00066781|B1|Baseline|Cohort I|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Irinotecan dose may be escalated or de-escalated after course 1 depending on toxicity. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
1256351|NCT00066781|P2|Participant Flow|Cohort II|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
1256352|NCT00066781|P1|Participant Flow|Cohort I|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Irinotecan dose may be escalated or de-escalated after course 1 depending on toxicity. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
1256353|NCT00066781|O2|Outcome|Cohort II|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
1256354|NCT00066781|O1|Outcome|Cohort I|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Irinotecan dose may be escalated or de-escalated after course 1 depending on toxicity. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
1256942|NCT00063635|E1|Reported Event|Metformin|Metformin, 500 mg, twice daily
1256355|NCT00066781|O2|Outcome|Cohort II|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
1256356|NCT00066781|O1|Outcome|Cohort I|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Irinotecan dose may be escalated or de-escalated after course 1 depending on toxicity. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
1256357|NCT00066781|O2|Outcome|Cohort II|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
1256358|NCT00066781|O1|Outcome|Cohort I|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Irinotecan dose may be escalated or de-escalated after course 1 depending on toxicity. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
1256551|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
1256359|NCT00066781|E2|Reported Event|Cohort II|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
1256360|NCT00066781|E1|Reported Event|Cohort I|Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Irinotecan dose may be escalated or de-escalated after course 1 depending on toxicity. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
1256361|NCT00066742|B1|Baseline|Evaluable Patients|Only eligible patients who received the study intervention were included in the analysis.
1256362|NCT00066742|P1|Participant Flow|Evaluable Patients|Only eligible patients who received the study intervention were included in the analysis.
1256363|NCT00066742|O1|Outcome|Evaluable Patients|
1256364|NCT00066742|O1|Outcome|Evaluable Patients With Measurable Disease|Only eligible patients who received protocol treatment and who had measurable lesions (per RECIST) at baseline were included in this analysis.
1256365|NCT00066742|O1|Outcome|Evaluable Patients|
1256366|NCT00066742|E2|Reported Event|Consolidation Cisplatin + Etoposide|
1256367|NCT00066742|E1|Reported Event|Tirapazamine + Cisplatin + Etoposide + Concurrent Radiotherapy|
1256368|NCT00066703|B3|Baseline|Total|Total of all reporting groups
1256369|NCT00066703|B2|Baseline|E+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
1256370|NCT00066703|B1|Baseline|T+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
1256371|NCT00066703|P2|Participant Flow|E+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
1256372|NCT00066703|P1|Participant Flow|T+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
1256373|NCT00066703|O2|Outcome|E+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
1256374|NCT00066703|O1|Outcome|T+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
1256375|NCT00066703|O2|Outcome|E+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
1256376|NCT00066703|O1|Outcome|T+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
1256377|NCT00066703|O2|Outcome|E+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
1256378|NCT00066703|O1|Outcome|T+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
1256454|NCT00066170|P3|Participant Flow|Xyrem Placebo + Modafinil at Established Dose|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
1256943|NCT00063622|B4|Baseline|Total|Total of all reporting groups
1256379|NCT00066703|E2|Reported Event|E+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
1256380|NCT00066703|E1|Reported Event|T+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
1256381|NCT00066690|B4|Baseline|Total|Total of all reporting groups
1256382|NCT00066690|B3|Baseline|E+OFS|Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
1256383|NCT00066690|B2|Baseline|T+OFS|Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
1256384|NCT00066690|B1|Baseline|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
1256385|NCT00066690|P3|Participant Flow|E+OFS|Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
1256386|NCT00066690|P2|Participant Flow|T+OFS|Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
1256387|NCT00066690|P1|Participant Flow|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
1256388|NCT00066690|O3|Outcome|E+OFS|Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
1256389|NCT00066690|O2|Outcome|T+OFS|Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
1256390|NCT00066690|O1|Outcome|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
1256391|NCT00066690|O3|Outcome|E+OFS|Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
1256392|NCT00066690|O2|Outcome|T+OFS|Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
1256393|NCT00066690|O1|Outcome|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
1256394|NCT00066690|O3|Outcome|E+OFS|Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
1256395|NCT00066690|O2|Outcome|T+OFS|Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
1256396|NCT00066690|O1|Outcome|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
1256397|NCT00066690|E3|Reported Event|E+OFS|Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
1256398|NCT00066690|E2|Reported Event|T+OFS|Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
1256399|NCT00066690|E1|Reported Event|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
1256400|NCT00066573|B3|Baseline|Total|Total of all reporting groups
1256401|NCT00066573|B2|Baseline|Anastrozole|"Patients receive oral anastrozole (1 mg) once daily for 5 years.~anastrozole: Given orally"
1256402|NCT00066573|B1|Baseline|Exemestane|"Patients receive oral exemestane (25 mg) once daily for 5 years.~exemestane: Given orally"
1256403|NCT00066573|P2|Participant Flow|Anastrozole|"Patients receive oral anastrozole (1 mg) once daily for 5 years.~anastrozole: Given orally"
1256404|NCT00066573|P1|Participant Flow|Exemestane|"Patients receive oral exemestane (25 mg) once daily for 5 years.~exemestane: Given orally"
1256405|NCT00066573|O2|Outcome|Anastrozole|"Patients receive oral anastrozole (1 mg) once daily for 5 years.~anastrozole: Given orally"
1256406|NCT00066573|O1|Outcome|Exemestane|"Patients receive oral exemestane (25 mg) once daily for 5 years.~exemestane: Given orally"
1256407|NCT00066573|E2|Reported Event|Anastrozole|"Patients receive oral anastrozole (1 mg) once daily for 5 years.~anastrozole: Given orally"
1256408|NCT00066573|E1|Reported Event|Exemestane|"Patients receive oral exemestane (25 mg) once daily for 5 years.~exemestane: Given orally"
1256409|NCT00066469|B1|Baseline|Cyclophosphamide, Prednisone, Rituximab|Patients receive cyclophosphamide IV over 30-60 minutes on day 1 and oral prednisone or methylprednisolone IV twice daily on days 1-5. During courses 1 and 2 only, patients also receive rituximab IV over 2-5 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression, a new primary or secondary malignancy, or unrelated disease.
1256410|NCT00066469|P1|Participant Flow|Cyclophosphamide, Prednisone, Rituximab|Patients receive cyclophosphamide IV over 30-60 minutes on day 1 and oral prednisone or methylprednisolone IV twice daily on days 1-5. During courses 1 and 2 only, patients also receive rituximab IV over 2-5 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression, a new primary or secondary malignancy, or unrelated disease.
1256411|NCT00066469|O1|Outcome|Cyclophosphamide, Prednisone, Rituximab|Patients receive cyclophosphamide IV over 30-60 minutes on day 1 and oral prednisone or methylprednisolone IV twice daily on days 1-5. During courses 1 and 2 only, patients also receive rituximab IV over 2-5 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression, a new primary or secondary malignancy, or unrelated disease.
1256618|NCT00065468|O2|Outcome|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
1256412|NCT00066469|E1|Reported Event|Cyclophosphamide, Prednisone, Rituximab|Patients receive cyclophosphamide IV over 30-60 minutes on day 1 and oral prednisone or methylprednisolone IV twice daily on days 1-5. During courses 1 and 2 only, patients also receive rituximab IV over 2-5 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression, a new primary or secondary malignancy, or unrelated disease.
1256413|NCT00066365|B3|Baseline|Total|Total of all reporting groups
1256414|NCT00066365|B2|Baseline|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
1256552|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
1256553|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
1256415|NCT00066365|B1|Baseline|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
1256416|NCT00066365|P2|Participant Flow|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
1256417|NCT00066365|P1|Participant Flow|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
1256418|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
1256419|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
1256420|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
1256944|NCT00063622|B3|Baseline|Placebo|Placebo Pioglitazone and Placebo Vitamin E
1256945|NCT00063622|B2|Baseline|Vitamin E|Vitamin E at a dose of 800 IU daily
1256421|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
1256422|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
1256554|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
1256423|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
1256424|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
1256425|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
1256426|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
1256427|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
1256428|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
1256429|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
1256430|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
1256555|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
1256431|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
1256432|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
1256433|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
1256434|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
1256435|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
1256436|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms~conventional surgery: thoracotomy"
1256437|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
1256438|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
1256556|NCT00065507|O4|Outcome|Cumulative - Adefovir (ADV) 10 mg|
1256557|NCT00065507|O3|Outcome|Cumulative - Entecavir (ETV) 1.0 mg|
1256439|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
1256440|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
1256441|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
1256442|NCT00066365|E2|Reported Event|Group 2 (Bilateral Recurrence)|"(See Detailed Description and Interventions for drugs, dosages, delivery method and frequency.)~sargramostim: given by inhalation~conventional surgery: thoracotomy"
1256443|NCT00066365|E1|Reported Event|Group 1 (Unilateral Recurrence)|"(See Detailed Description and Interventions for drugs, dosages, delivery method and frequency.)~sargramostim: given by inhalation~conventional surgery: thoracotomy"
1256444|NCT00066222|B1|Baseline|Radiation Therapy + Chemotherapy|Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
1256445|NCT00066222|P1|Participant Flow|Radiation Therapy + Chemotherapy|Accelerated high dose thoracic radiation therapy (RT) with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
1256446|NCT00066222|O1|Outcome|Radiation Therapy + Chemotherapy|Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
1256447|NCT00066222|E1|Reported Event|Radiation Therapy + Chemotherapy|Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
1256448|NCT00066170|B5|Baseline|Total|Total of all reporting groups
1256449|NCT00066170|B4|Baseline|Xyrem + Modafinil at Established Dose|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
1256450|NCT00066170|B3|Baseline|Xyrem Placebo + Modafinil at Established Dose|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
1256451|NCT00066170|B2|Baseline|Xyrem + Modafinil Placebo|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
1256452|NCT00066170|B1|Baseline|Xyrem Placebo + Modafinil Placebo|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
1256453|NCT00066170|P4|Participant Flow|Xyrem + Modafinil at Established Dose|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
1256946|NCT00063622|B1|Baseline|Pioglitazone|Pioglitazone at a dose of 30 mg daily
1256455|NCT00066170|P2|Participant Flow|Xyrem + Modafinil Placebo|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
1256456|NCT00066170|P1|Participant Flow|Xyrem Placebo + Modafinil Placebo|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
1256457|NCT00066170|O4|Outcome|Xyrem + Modafinil at Established Dose|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
1256458|NCT00066170|O3|Outcome|Xyrem Placebo + Modafinil at Established Dose|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
1256459|NCT00066170|O2|Outcome|Xyrem + Modafinil Placebo|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
1256460|NCT00066170|O1|Outcome|Xyrem Placebo + Modafinil Placebo|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
1256461|NCT00066170|E4|Reported Event|Xyrem + Modafinil at Established Dose|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
1256462|NCT00066170|E3|Reported Event|Xyrem Placebo + Modafinil at Established Dose|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
1256463|NCT00066170|E2|Reported Event|Xyrem + Modafinil Placebo|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
1256464|NCT00066170|E1|Reported Event|Xyrem Placebo + Modafinil Placebo|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
1256465|NCT00066066|B4|Baseline|Total|Total of all reporting groups
1256466|NCT00066066|B3|Baseline|SRP and Amoxicillin, MET and Locally Delivered Tetracycline|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
1256467|NCT00066066|B2|Baseline|SRP and Metronidazole (MET)|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
1256468|NCT00066066|B1|Baseline|Scaling and Root Planing (SRP) Only|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
1256469|NCT00066066|P6|Participant Flow|SRP and Amoxicillin, MET, Local Tetracycline Smokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
1256470|NCT00066066|P5|Participant Flow|SRP and Amoxicillin, MET, Local Tetracycline NonSmokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
1256471|NCT00066066|P4|Participant Flow|SRP and Metronidazole (MET) Smokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
1256472|NCT00066066|P3|Participant Flow|SRP and Metronidazole (MET) NonSmokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
1256473|NCT00066066|P2|Participant Flow|SRP Only Smokers|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
1256474|NCT00066066|P1|Participant Flow|Scaling and Root Planing (SRP) Only NonSmokers|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
1256475|NCT00066066|O6|Outcome|SRP + MET + Amoxicillin + Doxycycline Smokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
1256476|NCT00066066|O5|Outcome|SRP + MET + Amoxicillin + Doxycycline NonSmokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
1256477|NCT00066066|O4|Outcome|SRP + Metronidazole Smokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
1256478|NCT00066066|O3|Outcome|SRP + Metronidazole NonSmokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
1256479|NCT00066066|O2|Outcome|SRP Only Smokers|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
1256480|NCT00066066|O1|Outcome|Scaling and Root Planing Only NonSmokers|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
1256481|NCT00066066|E6|Reported Event|SRP and Amoxicillin, MET, Local Tetracycline Smokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
1256482|NCT00066066|E5|Reported Event|SRP and Amoxicillin, MET, Local Tetracycline NonSmokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
1256483|NCT00066066|E4|Reported Event|SRP and Metronidazole (MET) Smokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
1256484|NCT00066066|E3|Reported Event|SRP and Metronidazole (MET) NonSmokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
1256485|NCT00066066|E2|Reported Event|SRP Only Smokers|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
1256486|NCT00066066|E1|Reported Event|Scaling and Root Planing (SRP) Only NonSmokers|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
1256487|NCT00065806|B3|Baseline|Total|Total of all reporting groups
1256488|NCT00065806|B2|Baseline|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256489|NCT00065806|B1|Baseline|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256490|NCT00065806|P2|Participant Flow|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256613|NCT00065468|B1|Baseline|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
1256614|NCT00065468|P3|Participant Flow|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
1256615|NCT00065468|P2|Participant Flow|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
1256947|NCT00063622|P3|Participant Flow|Placebo|Placebo Pioglitazone and Placebo Vitamin E
1256491|NCT00065806|P1|Participant Flow|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256492|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256493|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256494|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256495|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256496|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256497|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256498|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256616|NCT00065468|P1|Participant Flow|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
1256499|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256500|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256501|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256558|NCT00065507|O2|Outcome|Week 48 - Adefovir (ADV) 10 mg|
1256559|NCT00065507|O1|Outcome|Week 48 - Entecavir (ETV) 1.0 mg|
1256560|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
1256502|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256503|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256504|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256505|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256506|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256507|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256508|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256509|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256561|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
1256562|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
1256563|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
1256510|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256511|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256512|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256513|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256514|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256515|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256516|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256517|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256564|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
1256565|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
1256566|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
1256518|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256519|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256520|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256521|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256522|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256523|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256524|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256525|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256567|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
1256568|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
1256569|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
1256526|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256527|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256528|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256529|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256530|NCT00065806|E2|Reported Event|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256531|NCT00065806|E1|Reported Event|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
1256532|NCT00065611|B3|Baseline|Total|Total of all reporting groups
1256533|NCT00065611|B2|Baseline|4 Doses Every 4 Weeks Arm|Patients in this arm receive 4 doses every 4 weeks
1256534|NCT00065611|B1|Baseline|2 Doses Every 2 Weeks Arm|Patients in this arm receive 2 doses every 2 weeks
1256535|NCT00065611|P2|Participant Flow|4 Doses Every 4 Weeks Arm|Patients in this arm receive 4 doses every 4 weeks
1256536|NCT00065611|P1|Participant Flow|2 Doses Every 2 Weeks Arm|Patients in this arm receive 2 doses every 2 weeks
1256537|NCT00065611|O2|Outcome|4 Doses Every 4 Weeks Arm|Patients in this arm receive 4 doses every 4 weeks
1256538|NCT00065611|O1|Outcome|2 Doses Every 2 Weeks Arm|Patients in this arm receive 2 doses every 2 weeks
1256539|NCT00065611|O2|Outcome|4 Doses Every 4 Weeks Arm|Patients in this arm receive 4 doses every 4 weeks
1256540|NCT00065611|O1|Outcome|2 Doses Every 2 Weeks Arm|Patients in this arm receive 2 doses every 2 weeks
1256541|NCT00065611|O2|Outcome|4 Doses Every 4 Weeks Arm|Patients in this arm receive 4 doses every 4 weeks
1256542|NCT00065611|O1|Outcome|2 Doses Every 2 Weeks Arm|Patients in this arm receive 2 doses every 2 weeks
1256543|NCT00065611|E2|Reported Event|4 Doses Every 4 Weeks Arm|Patients in this arm receive 4 doses every 4 weeks
1256544|NCT00065611|E1|Reported Event|2 Doses Every 2 Weeks Arm|Patients in this arm receive 2 doses every 2 weeks
1256545|NCT00065507|B3|Baseline|Total|Total of all reporting groups
1256546|NCT00065507|B2|Baseline|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
1256547|NCT00065507|B1|Baseline|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
1256548|NCT00065507|P2|Participant Flow|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
1256657|NCT00065429|B6|Baseline|IMGN 67.5 mg/m2|Arm 6, Phase 1
1256573|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
1256574|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
1256575|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
1256576|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
1256577|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
1256578|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
1256579|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
1256580|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
1256581|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
1256582|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
1256583|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
1256584|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
1256585|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
1256586|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
1256587|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
1256588|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
1256589|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
1256590|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
1256591|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
1256592|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
1256593|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
1256594|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
1256595|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
1256596|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
1256597|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
1256598|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
1256599|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
1256600|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
1256601|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
1256602|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
1256603|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
1256604|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
1256605|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
1256606|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
1256607|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
1256608|NCT00065507|E2|Reported Event|ENTECAVIR|
1256609|NCT00065507|E1|Reported Event|ADEFOVIR|
1256610|NCT00065468|B4|Baseline|Total|Total of all reporting groups
1256611|NCT00065468|B3|Baseline|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
1256612|NCT00065468|B2|Baseline|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
1256617|NCT00065468|O3|Outcome|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
1256619|NCT00065468|O1|Outcome|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
1256620|NCT00065468|O3|Outcome|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
1256621|NCT00065468|O2|Outcome|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
1256622|NCT00065468|O1|Outcome|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
1256623|NCT00065468|O3|Outcome|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
1256624|NCT00065468|O2|Outcome|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
1256625|NCT00065468|O1|Outcome|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
1256658|NCT00065429|B5|Baseline|IMGN 60 mg/m2|Arm 5, Phase 1 and 2
1256626|NCT00065468|O3|Outcome|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
1256627|NCT00065468|O2|Outcome|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
1256628|NCT00065468|O1|Outcome|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
1256629|NCT00065468|O3|Outcome|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
1256630|NCT00065468|O2|Outcome|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
1256631|NCT00065468|O1|Outcome|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
1256632|NCT00065468|O3|Outcome|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
1256633|NCT00065468|O2|Outcome|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
1256634|NCT00065468|O1|Outcome|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
1256635|NCT00065468|O3|Outcome|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
1256636|NCT00065468|O2|Outcome|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
1256637|NCT00065468|O1|Outcome|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
1256638|NCT00065468|O3|Outcome|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
1256639|NCT00065468|O2|Outcome|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
1256640|NCT00065468|O1|Outcome|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
1256641|NCT00065468|E3|Reported Event|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
1256642|NCT00065468|E2|Reported Event|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
1256643|NCT00065468|E1|Reported Event|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
1256644|NCT00065442|B3|Baseline|Total|Total of all reporting groups
1256645|NCT00065442|B2|Baseline|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
1256646|NCT00065442|B1|Baseline|APC-Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
1256647|NCT00065442|P2|Participant Flow|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
1256648|NCT00065442|P1|Participant Flow|APC-Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
1256948|NCT00063622|P2|Participant Flow|Vitamin E|Vitamin E at a dose of 800 IU daily
1256649|NCT00065442|O2|Outcome|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
1256650|NCT00065442|O1|Outcome|APC-Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
1256651|NCT00065442|O2|Outcome|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
1256652|NCT00065442|O1|Outcome|APC-Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
1256653|NCT00065442|E2|Reported Event|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
1256654|NCT00065442|E1|Reported Event|APC-Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
1256655|NCT00065429|B8|Baseline|Total|Total of all reporting groups
1256656|NCT00065429|B7|Baseline|IMGN 75 mg/m2|Arm 7, Phase 1
1256670|NCT00065429|O2|Outcome|Phase II|For Phase II, the planned design was to use a Gehan's two-stage design [4], with a total of 14 patients assigned to each of 2 dose levels. The dose levels to be tested were to be selected after review of the Phase I data and, assuming evidence of efficacy was seen in that phase, were likely to be the MTD and MTD-1.
1256671|NCT00065429|O1|Outcome|Phase I|The study had a conventional open-label cytotoxic study design to determine the safety, tolerability and MTD, preliminary efficacy signal and PK. Once the MTD was found in Phase I, the study would continue to a Phase II expansion at the MTD and the MTD-1 dose levels determined in Phase I. Infusions given at 1-week intervals were expected to provide intermittent exposure with no accumulation of BB-10901. The maximum duration of treatment at each dose level was 4 cycles of treatment; patients with evidence of response were eligible to continue for up to 6 cycles of treatment. Dose levels planned were 5, 10, 20, 40, 60 and 90 mg/m2/week. Three patients were to be enrolled per dose level with dose escalation when 1 of 3 patients completed 1 cycle and 2 patients had received at least 2 weekly infusions and were eligible for their third infusion, all without DLT. Once the MTD had been defined, 3 more patients were planned for enrollment at the MTD and 3 patients at the MTD-1 level.
1256672|NCT00065429|O1|Outcome|Phase I|The study had a conventional open-label cytotoxic study design to determine the safety, tolerability and MTD, preliminary efficacy signal and PK. Once the MTD was found in Phase I, the study would continue to a Phase II expansion at the MTD and the MTD-1 dose levels determined in Phase I. Infusions given at 1-week intervals were expected to provide intermittent exposure with no accumulation of BB-10901. The maximum duration of treatment at each dose level was 4 cycles of treatment; patients with evidence of response were eligible to continue for up to 6 cycles of treatment. Dose levels planned were 5, 10, 20, 40, 60 and 90 mg/m2/week. Three patients were to be enrolled per dose level with dose escalation when 1 of 3 patients completed 1 cycle and 2 patients had received at least 2 weekly infusions and were eligible for their third infusion, all without DLT. Once the MTD had been defined, 3 more patients were planned for enrollment at the MTD and 3 patients at the MTD-1 level.
1256673|NCT00065429|E7|Reported Event|IMGN 75 mg/m2|Arm 7, Phase 1
1256674|NCT00065429|E6|Reported Event|IMGN 67.5 mg/m2|Arm 6, Phase 1
1256675|NCT00065429|E5|Reported Event|IMGN 60 mg/m2|Arm 5, Phase 1 and 2
1256676|NCT00065429|E4|Reported Event|IMGN 40 mg/m2|Arm 4, Phase 1
1256677|NCT00065429|E3|Reported Event|IMGN 20 mg/m2|Arm 3, Phase 1
1256678|NCT00065429|E2|Reported Event|IMGN 10 mg/m2|Arm 2, Phase 1
1256679|NCT00065429|E1|Reported Event|IMGN 5 mg/m2|Arm 1, Phase 1
1256680|NCT00065260|B3|Baseline|Total|Total of all reporting groups
1256681|NCT00065260|B2|Baseline|Alemtuzumab (Campath-1H)|"A randomized trial of rabbit anti-thymocyte globulin (ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).~Campath-1H: Campath-1H IV 10 days. Adults:10mg/day (children:0.2mg/kg/day)."
1256682|NCT00065260|B1|Baseline|r-ATG /Cyclosporine|"A randomized trial of rabbit anti-thymocyte globulin (r-ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).~r-ATG: Rabbit ATG 3.5mg/kg/day for consecutive 5 days~CsA: CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs."
1256683|NCT00065260|P2|Participant Flow|Alemtuzumab (Campath-1H)|"A randomized trial of rabbit anti-thymocyte globulin (ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).~Campath-1H: Campath-1H IV 10 days. Adults:10mg/day (children:0.2mg/kg/day)."
1256696|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
1256684|NCT00065260|P1|Participant Flow|r-ATG /Cyclosporine|"A randomized trial of rabbit anti-thymocyte globulin (r-ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).~r-ATG: Rabbit ATG 3.5mg/kg/day for consecutive 5 days~CsA: CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs."
1256685|NCT00065260|O2|Outcome|Alemtuzumab (Campath-1H)|"A randomized trial of rabbit anti-thymocyte globulin (ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).~Campath-1H: Campath-1H IV 10 days. Adults:10mg/day (children:0.2mg/kg/day)."
1256686|NCT00065260|O1|Outcome|r-ATG /Cyclosporine|"A randomized trial of rabbit anti-thymocyte globulin (r-ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).~r-ATG: Rabbit ATG 3.5mg/kg/day for consecutive 5 days~CsA: CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs."
1256740|NCT00064792|O2|Outcome|Simvastatin|Subjects began this phase by taking 0.5mg/kg/day of an oral suspension with active drug for 6 weeks followed by a daily dose of 1mg/kg/day. Subjects continued taking 150mg/kg/day of cholesterol suspension.
1256959|NCT00063622|O3|Outcome|Placebo|Placebo Pioglitazone and Placebo Vitamin E
1256687|NCT00065260|E2|Reported Event|Alemtuzumab (Campath-1H)|"A randomized trial of rabbit anti-thymocyte globulin (ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).~Campath-1H: Campath-1H IV 10 days. Adults:10mg/day (children:0.2mg/kg/day)."
1256688|NCT00065260|E1|Reported Event|r-ATG /Cyclosporine|"A randomized trial of rabbit anti-thymocyte globulin (r-ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).~r-ATG: Rabbit ATG 3.5mg/kg/day for consecutive 5 days~CsA: CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs."
1256689|NCT00065156|B1|Baseline|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
1256690|NCT00065156|P1|Participant Flow|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
1256691|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
1256692|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
1256693|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
1256694|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
1256695|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
1256731|NCT00064844|E2|Reported Event|Nicotine Patch Plus Placebo Gum|
1256697|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
1256698|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
1256699|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
1256700|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
1256701|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
1256702|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
1256703|NCT00065156|E1|Reported Event|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
1256704|NCT00065065|B3|Baseline|Total|Total of all reporting groups
1256705|NCT00065065|B2|Baseline|Placebo|Identical in appearance to study drug taken twice a day
1256706|NCT00065065|B1|Baseline|Rosiglitazone|rosiglitazone (Avandia): 4mg orally twice daily
1256707|NCT00065065|P2|Participant Flow|Placebo|Placebo identical to study drug twice daily for 12 weeks
1256708|NCT00065065|P1|Participant Flow|Rosiglitazone|rosiglitazone (Avandia): 4mg orally twice daily for 12 weeks
1256709|NCT00065065|O2|Outcome|Placebo|Identical in appearance to study drug taken twice a day
1256710|NCT00065065|O1|Outcome|Rosiglitazone|rosiglitazone (Avandia): 4mg orally twice daily
1256711|NCT00065065|O2|Outcome|Placebo|Identical in appearance to study drug taken twice a day
1256712|NCT00065065|O1|Outcome|Rosiglitazone|rosiglitazone (Avandia): 4mg orally twice daily
1256713|NCT00065065|E2|Reported Event|Placebo|Identical in appearance to study drug taken twice a day
1256714|NCT00065065|E1|Reported Event|Rosiglitazone|rosiglitazone (Avandia): 4mg orally twice daily
1256715|NCT00064259|B1|Baseline|Oblimersen + Cisplatin + 5-FU|Oblimersen dose levels (3, 5, or 7 mg/kg/d) on days 1 to 7 in combination with 5-FU (1000 mg/m2/d or 750 mg/m2/d) on days 4 to 7 and Cisplatin (100 mg/m2 or 75 mg/m2) on day 4.
1256716|NCT00064259|P4|Participant Flow|Oblimersen 7 mg/kg/d +Cisplatin 75 mg/m2 +5-FU 750 mg/m2|Patients received oblimersen as a continuous intravenous infusion (CIVI) on days 1 to 7 at 7 mg/kg/d in combination with CIVI 5-FU 750 mg/m2/d on days 4 to 7 and cisplatin 75 mg/m2 on day 4.
1256717|NCT00064259|P3|Participant Flow|Oblimersen 5 mg/kg/d +Cisplatin 75 mg/m2 +5-FU 750 mg/m2|Patients received oblimersen as a continuous intravenous infusion (CIVI) on days 1 to 7 at 5 mg/kg/d in combination with CIVI 5-FU 750 mg/m2/d on days 4 to 7 and cisplatin 75 mg/m2 on day 4.
1256718|NCT00064259|P2|Participant Flow|Oblimersen 3 mg/kg/d +Cisplatin 75 mg/m2 +5-FU 750 mg/m2|Patients received oblimersen as a continuous intravenous infusion (CIVI) on days 1 to 7 at 3 mg/kg/d in combination with CIVI 5-FU 750 mg/m2/d on days 4 to 7 and cisplatin 75 mg/m2 on day 4.
1256719|NCT00064259|P1|Participant Flow|Oblimersen 3 mg/kg/d +Cisplatin 100 mg/m2 +5-FU 1000 mg/m2|Patients received oblimersen as a continuous intravenous infusion (CIVI) on days 1 to 7 at 3 mg/kg/d in combination with CIVI 5-FU 1000 mg/m2/d on days 4 to 7 and cisplatin 100 mg/m2 on day 4.
1256720|NCT00064259|O1|Outcome|Oblimersen + Cisplatin + 5-FU|Oblimersen dose levels (3, 5, or 7 mg/kg/d) on days 1 to 7 in combination with 5-FU (1000 mg/m2/d or 750 mg/m2/d) on days 4 to 7 and Cisplatin (100 mg/m2 or 75 mg/m2) on day 4.
1256721|NCT00064259|E1|Reported Event|Oblimersen + Cisplatin + 5-FU|Oblimersen dose levels (3, 5, or 7 mg/kg/d) on days 1 to 7 in combination with 5-FU (1000 mg/m2/d or 750 mg/m2/d) on days 4 to 7 and Cisplatin (100 mg/m2 or 75 mg/m2) on day 4.
1256722|NCT00064844|B3|Baseline|Total|Total of all reporting groups
1256723|NCT00064844|B2|Baseline|Nicotine Patch Plus Placebo Gum|
1256724|NCT00064844|B1|Baseline|Nicotine Patch Plus Active Gum|
1256725|NCT00064844|P2|Participant Flow|Nicotine Patch Plus Placebo Gum|
1256726|NCT00064844|P1|Participant Flow|Nicotine Patch Plus Active Gum|
1256727|NCT00064844|O2|Outcome|Nicotine Patch Plus Placebo Gum|
1256728|NCT00064844|O1|Outcome|Nicotine Patch Plus Active Gum|
1256729|NCT00064844|O2|Outcome|Nicotine Patch Plus Placebo Gum|
1256730|NCT00064844|O1|Outcome|Nicotine Patch Plus Active Gum|
1256734|NCT00064792|B2|Baseline|Simvastatin Followed by Placebo|Subjects began this phase by taking 0.5mg/kg/day of an oral suspension with active drug for 6 weeks followed by a daily dose of 1mg/kg/day. Subjects continued taking 150mg/kg/day of cholesterol suspension.
1256735|NCT00064792|B1|Baseline|Placebo Followed by Simvastatin|During the placebo phase, subjects were given a daily dose of an oral suspension not containing active drug. All subjects continued taking cholesterol suspension at 150mg/kg/day.
1256736|NCT00064792|P2|Participant Flow|Simvastatin Followed by Placebo|Subjects first received Simvastatin (1mg/kg/day after starting at 0.5mg/kg/day for 6 weeks) in addition to cholesterol 150mg/kg/day for 12 months. After a 2 month wash out period, they then continued with cholesterol supplementation only.
1256737|NCT00064792|P1|Participant Flow|Placebo Followed by Simvastatin|Subjects maintained cholesterol intake of 150mg/kg/day for 12 months. After a 2 month wash out period, they then received Simvastatin 1mg/kg/day (after starting at 0.5mg/kg/day for 6 weeks) in addition to cholesterol.
1256738|NCT00064792|O2|Outcome|Simvastatin|Subjects began this phase by taking 0.5mg/kg/day of an oral suspension with active drug for 6 weeks followed by a daily dose of 1mg/kg/day. Subjects continued taking 150mg/kg/day of cholesterol suspension.
1256739|NCT00064792|O1|Outcome|Not Simvastatin|During the placebo phase, subjects were given a daily dose of an oral suspension (OraPlus) not containing active drug. All subjects continued taking cholesterol suspension at 150mg/kg/day.
1256741|NCT00064792|O1|Outcome|Not Simvastatin|During the placebo phase, subjects were given a daily dose of an oral suspension (OraPlus) not containing active drug. All subjects continued taking cholesterol suspension at 150mg/kg/day.
1256742|NCT00064792|E2|Reported Event|Simvastatin Susp|Subjects began this phase by taking 0.5mg/kg/day of an oral suspension with active drug for 6 weeks followed by a daily dose of 1mg/kg/day. Subjects continued taking 150mg/kg/day of cholesterol suspension.
1256743|NCT00064792|E1|Reported Event|OraPlus|During the placebo phase, subjects were given a daily dose of an oral suspension not containing active drug. All subjects continued taking cholesterol suspension at 150mg/kg/day.
1256744|NCT00064753|B3|Baseline|Total|Total of all reporting groups
1256745|NCT00064753|B2|Baseline|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
1256746|NCT00064753|B1|Baseline|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
1256747|NCT00064753|P2|Participant Flow|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
1256748|NCT00064753|P1|Participant Flow|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
1256749|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
1256750|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
1256751|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
1256752|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
1256753|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
1256754|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
1256755|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
1256756|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
1256757|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
1256758|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
1256759|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
1256760|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
1256960|NCT00063622|O2|Outcome|Vitamin E|Vitamin E at a dose of 800 IU daily
1256761|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
1256762|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
1256763|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
1256764|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
1256765|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
1256766|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
1256767|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
1256768|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
1256769|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
1256770|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
1256771|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
1256772|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
1256773|NCT00064753|E2|Reported Event|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
1256774|NCT00064753|E1|Reported Event|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
1256776|NCT00064701|B3|Baseline|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256777|NCT00064701|B2|Baseline|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256778|NCT00064701|B1|Baseline|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256961|NCT00063622|O1|Outcome|Pioglitazone|Pioglitazone at a dose of 30 mg daily
1256962|NCT00063622|O3|Outcome|Placebo|Placebo Pioglitazone and Placebo Vitamin E
1256779|NCT00064701|P3|Participant Flow|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256780|NCT00064701|P2|Participant Flow|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256781|NCT00064701|P1|Participant Flow|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256782|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256783|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256784|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256785|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256786|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256787|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256788|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256789|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256790|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256949|NCT00063622|P1|Participant Flow|Pioglitazone|Pioglitazone at a dose of 30 mg daily
1256950|NCT00063622|O3|Outcome|Placebo|Placebo Pioglitazone and Placebo Vitamin E
1256791|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256792|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256793|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256794|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256795|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256796|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256797|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256798|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256799|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256800|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256801|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256802|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256803|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256804|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256805|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256806|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256807|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256808|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256809|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256867|NCT00064038|O2|Outcome|Dexamethasone|Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
1256963|NCT00063622|O2|Outcome|Vitamin E|Vitamin E at a dose of 800 IU daily
1256810|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256811|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256812|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256813|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256814|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256815|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256816|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256817|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256818|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256819|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256820|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256821|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256822|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256823|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256824|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256890|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
1256964|NCT00063622|O1|Outcome|Pioglitazone|Pioglitazone at a dose of 30 mg daily
1256825|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256826|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256827|NCT00064701|E3|Reported Event|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256828|NCT00064701|E2|Reported Event|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256829|NCT00064701|E1|Reported Event|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
1256830|NCT00064662|B3|Baseline|Total|Total of all reporting groups
1256831|NCT00064662|B2|Baseline|Sling|Pubovaginal sling, using autologous rectus fascia
1256832|NCT00064662|B1|Baseline|Burch|The Burch colposuspension
1256833|NCT00064662|P2|Participant Flow|Sling|Pubovaginal sling, using autologous rectus fascia
1256834|NCT00064662|P1|Participant Flow|Burch|The Burch colposuspension
1256835|NCT00064662|O2|Outcome|Sling|Pubovaginal sling, using autologous rectus fascia
1256836|NCT00064662|O1|Outcome|Burch|The Burch colposuspension
1256837|NCT00064662|O2|Outcome|Sling|Pubovaginal sling, using autologous rectus fascia
1256838|NCT00064662|O1|Outcome|Burch|The Burch colposuspension
1256839|NCT00064662|E2|Reported Event|Sling|Pubovaginal sling, using autologous rectus fascia
1256840|NCT00064662|E1|Reported Event|Burch|The Burch colposuspension
1256841|NCT00064350|B4|Baseline|Total|Total of all reporting groups
1256842|NCT00064350|B3|Baseline|Induction, Not Randomized|"Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity.~Patients with responding disease continue to receive sorafenib for up to 1 year in the absence of disease progression.~Randomization: Patients with stable disease after the induction treatment were randomized to either the sorafenib arm or the placebo arm.~To show baseline characteristics for eligible and treated patients in both the randomization phase (the most important part of this study) and the induction phase, this group contains the following patients:~eligible and treated patients who were not randomized (n=194)~randomized patients who were not eligible or did not start treatment in the randomization phase (n=24)~There were 218 patients in this group so the total number of patients is 299 and the entire cohort represents all eligible and treated patients in the induction phase."
1256843|NCT00064350|B2|Baseline|Induction Then Placebo Then Sorafenib|"Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease proceed to randomization. Patients with responding disease continue to receive sorafenib for up to 1 year in the absence of disease progression.~Randomization: Patients with stable disease after the induction treatment were randomized to either the sorafenib arm or the placebo arm. Patients on the sorafenib arm receive sorafenib twice daily for up to 1 year in the absence of disease progression or unacceptable disease. Patients on the placebo arm receive oral placebo twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients on the placebo arm who develop disease progression within 1 year after randomization may cross over to sorafenib arm."
1256951|NCT00063622|O2|Outcome|Vitamin E|Vitamin E at a dose of 800 IU daily
1256952|NCT00063622|O1|Outcome|Pioglitazone|Pioglitazone at a dose of 30 mg daily
1256844|NCT00064350|B1|Baseline|Induction Then Sorafenib|"Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease proceed to randomization.~Randomization: Patients with stable disease after the induction treatment were randomized to receive either sorafenib or placebo. Patients on the sorafenib arm receive sorafenib twice daily for up to 1 year in the absence of disease progression or unacceptable disease.~In the study design, only patients on the placebo arm with progressive disease may cross over to receive sorafenib. Due to drug dispensing error, even though some patients actually received straight sorafenib during Step 2 (randomization) treatment, they were thought to be randomized onto the placebo arm upon progression and unblinding (before finding out the fact of the dispensing error). Consequently, these patients were crossed over to Step 3, and there were 10 of them."
1256845|NCT00064350|P3|Participant Flow|Induction, Not Randomized|"Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity.~Patients with responding disease continue to receive sorafenib for up to 1 year in the absence of disease progression.~Randomization: Patients with stable disease after the induction treatment were randomized to either the sorafenib arm or the placebo arm. Patients in this group did not enter Step 2 (randomization part) after the induction phase."
1256866|NCT00064038|P1|Participant Flow|Lenalidomide+Dexamethasone|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1256846|NCT00064350|P2|Participant Flow|Induction Then Placebo Then Sorafenib|"Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease proceed to randomization. Patients with responding disease continue to receive sorafenib for up to 1 year in the absence of disease progression.~Randomization: Patients with stable disease after the induction treatment were randomized to either the sorafenib arm or the placebo arm. Patients on the sorafenib arm receive sorafenib twice daily for up to 1 year in the absence of disease progression or unacceptable disease. Patients on the placebo arm receive oral placebo twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients on the placebo arm who develop disease progression within 1 year after randomization may cross over to sorafenib arm."
1256847|NCT00064350|P1|Participant Flow|Induction Then Sorafenib|"Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease proceed to randomization.~Randomization: Patients with stable disease after the induction treatment were randomized to receive either sorafenib or placebo. Patients on the sorafenib arm receive sorafenib twice daily for up to 1 year in the absence of disease progression or unacceptable disease.~In the study design, only patients on the placebo arm with progressive disease may cross over to receive sorafenib. Due to drug dispensing error, even though some patients actually received straight sorafenib during Step 2 (randomization) treatment, they were thought to be randomized onto the placebo arm upon progression and unblinding (before finding out the fact of the dispensing error). Consequently, these patients were crossed over to Step 3, and there were 10 of them."
1256848|NCT00064350|O2|Outcome|Placebo|Patients initially received placebo in Step 2 (randomization part)
1256849|NCT00064350|O1|Outcome|Sorafenib|Patients initially received Sorafenib in Step 2 (randomization part)
1256850|NCT00064350|O2|Outcome|Placebo|Patients initially received placebo in Step 2 (randomization part)
1256851|NCT00064350|O1|Outcome|Sorafenib|Patients initially received Sorafenib in Step 2 (randomization part)
1256852|NCT00064350|O2|Outcome|Placebo|Patients initially received placebo in Step 2 (randomization part)
1256853|NCT00064350|O1|Outcome|Sorafenib|Patients initially received Sorafenib in Step 2 (randomization part)
1256854|NCT00064350|O2|Outcome|Placebo|Patients initially received placebo in Step 2 (randomization part)
1256855|NCT00064350|O1|Outcome|Sorafenib|Patients initially received Sorafenib in Step 2 (randomization part)
1256856|NCT00064350|E5|Reported Event|Crossover: Sorafenib|Patients on the placebo arm who develop progressive disease may cross over to receive sorafenib, and 27 patients from the placebo arm received sorafenib in Step 3 (crossover). Due to drug dispensing error, even though some patients actually received straight sorafenib during Step 2 (randomization) treatment, they were thought to be randomized onto the placebo arm upon progression and unblinding (before finding out the fact of the dispensing error). Consequently, these patients were crossed over to Step 3, and there were 10 of them. In total, 37 patients registered to step 3 (crossover). Of these, 35 patients received treatment and were included in the toxicity analysis for the crossover (step 3) part.
1256857|NCT00064350|E4|Reported Event|Randomization (Step 2): Mixed|"After induction treatment, patients with stable disease were randomized to receive either sorafenib or placebo. Due to drug dispensing error, 10 patients from the sorafenib arm and 2 patients from the placebo arm (12 pts in total) received mixed treatment with sorafenib and placebo and were categorized into Randomization (Step 2): Mixed group when reporting toxicities."
1256858|NCT00064350|E3|Reported Event|Randomization (Step 2): Placebo|"After induction treatment, 46 patients were randomized to the placebo arm. Among these, 40 received treatment. However, due to drug dispensing error, 2 of them received mixed treatment with sorafenib and placebo and were categorized into Randomization (Step 2): Mixed group when reporting toxicities. As a result, 38 treated patients were included in the randomization (step 2): placebo group."
1256859|NCT00064350|E2|Reported Event|Randomization (Step 2): Sorafenib|"After induction treatment, 59 patients were randomized to the sorafenib arm. Among these, 55 received treatment. However, due to drug dispensing error, 10 of them received mixed treatment with sorafenib and placebo and were categorized into Randomization (Step 2): Mixed group when reporting toxicities. As a result, 45 treated patients were included in the randomization (step 2): sorafenib group."
1256860|NCT00064350|E1|Reported Event|Induction: Sorafenib|All patients who received induction treatment (333 patients), regardless of eligibility status, were included in the toxicity analysis.
1256861|NCT00064038|B3|Baseline|Total|Total of all reporting groups
1256953|NCT00063622|O3|Outcome|Placebo|Placebo Pioglitazone and Placebo Vitamin E
1256862|NCT00064038|B2|Baseline|Dexamethasone|Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
1256863|NCT00064038|B1|Baseline|Lenalidomide+Dexamethasone|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1256864|NCT00064038|P3|Participant Flow|Crossover to Lenalidomide+Dexamethasone|"Patients who have progressive or relapsed disease or who experience unacceptable toxicity attributable to dexamethasone dosing level -2 while on blinded treatment, will be unblinded. Patients shown to have been randomized to DEX + Placebo will proceed with crossover registration and Open-Label Induction with DEX + CC-5013or with open-label CC-5013 alone if they are unblinded due to dexamethasone toxicity.~Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
1256865|NCT00064038|P2|Participant Flow|Dexamethasone|Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
1256868|NCT00064038|O1|Outcome|Lenalidomide+Dexamethasone|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1256869|NCT00064038|O3|Outcome|Crossover to Rev+Dex|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1256870|NCT00064038|O2|Outcome|Dexamethasone|Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
1256871|NCT00064038|O1|Outcome|Lenalidomide and Dexamethasone|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1256872|NCT00064038|E3|Reported Event|Crossover to Rev+Dex|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1256873|NCT00064038|E2|Reported Event|Dexamethasone|Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
1256874|NCT00064038|E1|Reported Event|Lenalidomide and Dexamethasone|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
1256875|NCT00064025|B1|Baseline|Depo-Provera|Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
1256876|NCT00064025|P1|Participant Flow|Depo-Provera|Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
1256877|NCT00064025|O1|Outcome|Depo-Provera|Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
1256878|NCT00064025|O1|Outcome|Depo-Provera|Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
1256879|NCT00064025|O2|Outcome|PR Positive (>0.2)|
1256880|NCT00064025|O1|Outcome|PR Negative (<=0.2)|
1256881|NCT00064025|E1|Reported Event|Depo-Provera|Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
1256882|NCT00063986|B1|Baseline|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
1256883|NCT00063986|P1|Participant Flow|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
1256884|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
1256885|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
1256886|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
1256887|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
1256888|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
1256889|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
1256957|NCT00063622|O2|Outcome|Vitamin E|Vitamin E at a dose of 800 IU daily
1256958|NCT00063622|O1|Outcome|Pioglitazone|Pioglitazone at a dose of 30 mg daily
1256891|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
1256892|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
1256893|NCT00063986|E1|Reported Event|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
1256894|NCT00063934|B1|Baseline|Oblimersen Plus Doxorubicin + Docetaxel|Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m^2 and Docetaxel 75 mg/m^2 infused on Day 6
1256895|NCT00063934|P1|Participant Flow|Oblimersen Plus Doxorubicin + Docetaxel|Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m^2 and Docetaxel 75 mg/m^2 infused on Day 6
1256896|NCT00063934|O1|Outcome|Oblimersen Plus Doxorubicin + Docetaxel|Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m^2 and Docetaxel 75 mg/m^2 infused on Day 6
1256897|NCT00063934|O1|Outcome|Oblimersen Plus Doxorubicin + Docetaxel|Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m^2 and Docetaxel 75 mg/m^2 infused on Day 6
1256898|NCT00063934|O1|Outcome|Oblimersen Plus Doxorubicin + Docetaxel|Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m^2 and Docetaxel 75 mg/m^2 infused on Day 6
1256899|NCT00063934|E1|Reported Event|Oblimersen Plus Doxorubicin + Docetaxel|Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m^2 and Docetaxel 75 mg/m^2 infused on Day 6
1256900|NCT00063635|B4|Baseline|Total|Total of all reporting groups
1256901|NCT00063635|B3|Baseline|Placebo|Matching placebo
1256902|NCT00063635|B2|Baseline|Vitamin E|Vitamin E, 400 IU, twice daily
1256903|NCT00063635|B1|Baseline|Metformin|Metformin, 500 mg, twice daily
1256904|NCT00063635|P3|Participant Flow|Placebo|Matching placebo
1256905|NCT00063635|P2|Participant Flow|Vitamin E|Vitamin E, 400 IU, twice daily
1256906|NCT00063635|P1|Participant Flow|Metformin|Metformin, 500 mg, twice daily
1256907|NCT00063635|O3|Outcome|Placebo|Matching placebo
1256908|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
1256909|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
1256910|NCT00063635|O3|Outcome|Placebo|Matching placebo
1256911|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
1256912|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
1256913|NCT00063635|O3|Outcome|Placebo|Matching placebo
1256914|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
1256915|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
1256916|NCT00063635|O3|Outcome|Placebo|Matching placebo
1256917|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
1256918|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
1256919|NCT00063635|O3|Outcome|Placebo|Matching placebo
1256920|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
1256921|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
1256922|NCT00063635|O3|Outcome|Placebo|Matching placebo
1256923|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
1256924|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
1256925|NCT00063635|O3|Outcome|Placebo|Matching placebo
1256926|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
1256927|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
1256928|NCT00063635|O3|Outcome|Placebo|Matching placebo
1256929|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
1256930|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
1256931|NCT00063635|O3|Outcome|Placebo|Matching placebo
1256932|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
1256933|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
1256934|NCT00063635|O3|Outcome|Placebo|Matching placebo
1256954|NCT00063622|O2|Outcome|Vitamin E|Vitamin E at a dose of 800 IU daily
1256955|NCT00063622|O1|Outcome|Pioglitazone|Pioglitazone at a dose of 30 mg daily
1256956|NCT00063622|O3|Outcome|Placebo|Placebo Pioglitazone and Placebo Vitamin E
1256965|NCT00063622|O3|Outcome|Placebo|Placebo Pioglitazone and Placebo Vitamin E
1256966|NCT00063622|O2|Outcome|Vitamin E|Vitamin E at a dose of 800 IU daily
1256967|NCT00063622|O1|Outcome|Pioglitazone|Pioglitazone at a dose of 30 mg daily
1256968|NCT00063622|E3|Reported Event|Placebo|Placebo Pioglitazone and Placebo Vitamin E
1256969|NCT00063622|E2|Reported Event|Vitamin E|Vitamin E at a dose of 800 IU daily
1256970|NCT00063622|E1|Reported Event|Pioglitazone|Pioglitazone at a dose of 30 mg daily
1256971|NCT00063570|B3|Baseline|Total|Total of all reporting groups
1256972|NCT00063570|B2|Baseline|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.~Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
1256973|NCT00063570|B1|Baseline|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.~Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
1256974|NCT00063570|P2|Participant Flow|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.~Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
1256975|NCT00063570|P1|Participant Flow|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.~Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
1256976|NCT00063570|O2|Outcome|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.~Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
1256977|NCT00063570|O1|Outcome|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.~Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
1256978|NCT00063570|O2|Outcome|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.~Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
1256979|NCT00063570|O1|Outcome|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.~Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
1256980|NCT00063570|O2|Outcome|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.~Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
1256981|NCT00063570|O1|Outcome|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.~Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
1256982|NCT00063570|O2|Outcome|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.~Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
1256983|NCT00063570|O1|Outcome|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.~Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
1256984|NCT00063570|O2|Outcome|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.~Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
1256985|NCT00063570|O1|Outcome|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.~Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
1256986|NCT00063570|E2|Reported Event|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.~Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
1256987|NCT00063570|E1|Reported Event|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.~Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
1256988|NCT00063362|B3|Baseline|Total|Total of all reporting groups
1256989|NCT00063362|B2|Baseline|Lithium + Divalproex + Placebo|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.~Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
1256990|NCT00063362|B1|Baseline|Lithium + Divalproex + Lamotrigine|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.~Lamotrigine : Patients were assigned in a one to one ratio to adjunctive lamotrigine versus placebo after stratification for illness type (bipolar I versus bipolar II), historical response to lithium (response versus non-response), and length of current exposure to combination treatment with lithium and divalproex (< 2 months versus ≥ 2 months). During Phase 2, patients were continued on the same doses of lithium and divalproex as during the open-label treatment phase and equal capsules of double-blind lamotrigine or matching placebo were gradually added per a structured dosing schedule up to a minimum dose of 150 mg and a maximum.~dose of 200 mg per day.~Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
1256991|NCT00063362|P2|Participant Flow|Lithium + Divalproex + Placebo|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.~Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
1257012|NCT00063154|B1|Baseline|Pertuzumab|Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
1257013|NCT00063154|P1|Participant Flow|Pertuzumab|Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
1257014|NCT00063154|O1|Outcome|Pertuzumab|Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
1256992|NCT00063362|P1|Participant Flow|Lithium + Divalproex + Lamotrigine|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.~Lamotrigine : Patients were assigned in a one to one ratio to adjunctive lamotrigine versus placebo after stratification for illness type (bipolar I versus bipolar II), historical response to lithium (response versus non-response), and length of current exposure to combination treatment with lithium and divalproex (< 2 months versus ≥ 2 months). During Phase 2, patients were continued on the same doses of lithium and divalproex as during the open-label treatment phase and equal capsules of double-blind lamotrigine or matching placebo were gradually added per a structured dosing schedule up to a minimum dose of 150 mg and a maximum.~dose of 200 mg per day.~Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 milliequivalent/L (mEq/L)."
1257117|NCT00062738|E3|Reported Event|Placebo|
1257118|NCT00062738|E2|Reported Event|Paroxetine|
1257119|NCT00062738|E1|Reported Event|Nortriptyline|
1256993|NCT00063362|O2|Outcome|Lithium + Divalproex + Placebo|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.~Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
1256994|NCT00063362|O1|Outcome|Lithium + Divalproex + Lamotrigine|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.~Lamotrigine : Patients were assigned in a one to one ratio to adjunctive lamotrigine versus placebo after stratification for illness type (bipolar I versus bipolar II), historical response to lithium (response versus non-response), and length of current exposure to combination treatment with lithium and divalproex (< 2 months versus ≥ 2 months). During Phase 2, patients were continued on the same doses of lithium and divalproex as during the open-label treatment phase and equal capsules of double-blind lamotrigine or matching placebo were gradually added per a structured dosing schedule up to a minimum dose of 150 mg and a maximum.~dose of 200 mg per day.~Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
1256995|NCT00063362|E2|Reported Event|Lithium + Divalproex + Placebo|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.~Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
1256996|NCT00063362|E1|Reported Event|Lithium + Divalproex + Lamotrigine|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.~Lamotrigine : Patients were assigned in a one to one ratio to adjunctive lamotrigine versus placebo after stratification for illness type (bipolar I versus bipolar II), historical response to lithium (response versus non-response), and length of current exposure to combination treatment with lithium and divalproex (< 2 months versus ≥ 2 months). During Phase 2, patients were continued on the same doses of lithium and divalproex as during the open-label treatment phase and equal capsules of double-blind lamotrigine or matching placebo were gradually added per a structured dosing schedule up to a minimum dose of 150 mg and a maximum.~dose of 200 mg per day.~Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
1256997|NCT00063258|B3|Baseline|Total|Total of all reporting groups
1256998|NCT00063258|B2|Baseline|Chemotherapy Alone|
1256999|NCT00063258|B1|Baseline|Chemotherapy + Tarceva|
1257000|NCT00063258|P2|Participant Flow|Chemotherapy Alone|
1257001|NCT00063258|P1|Participant Flow|Chemotherapy + Tarceva|
1257002|NCT00063258|O2|Outcome|Chemotherapy Alone|
1257003|NCT00063258|O1|Outcome|Chemotherapy + Tarceva|
1257004|NCT00063258|E2|Reported Event|Chemotherapy Alone|
1257005|NCT00063258|E1|Reported Event|Chemotherapy + Tarceva|
1257006|NCT00063232|B1|Baseline|Metformin|Participants will undergo a complete medical examination, a series of lab tests, and a liver biopsy. They will then start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same dosage twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will increase to 1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year, participants will undergo a repeat medical examination and liver biopsy.
1257007|NCT00063232|P1|Participant Flow|Metformin|Participants will undergo a complete medical examination, a series of lab tests, and a liver biopsy. They will then start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same dosage twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will increase to 1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year, participants will undergo a repeat medical examination and liver biopsy.
1257008|NCT00063232|O1|Outcome|Metformin|Participants will undergo a complete medical examination, a series of lab tests, and a liver biopsy. They will then start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same dosage twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will increase to 1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year, participants will undergo a repeat medical examination and liver biopsy.
1257009|NCT00063232|O1|Outcome|Metformin|Participants will undergo a complete medical examination, a series of lab tests, and a liver biopsy. They will then start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same dosage twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will increase to 1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year, participants will undergo a repeat medical examination and liver biopsy.
1257010|NCT00063232|O1|Outcome|Metformin|Participants will undergo a complete medical examination, a series of lab tests, and a liver biopsy. They will then start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same dosage twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will increase to 1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year, participants will undergo a repeat medical examination and liver biopsy.
1257011|NCT00063232|E1|Reported Event|Metformin|Participants will undergo a complete medical examination, a series of lab tests, and a liver biopsy. They will then start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same dosage twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will increase to 1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year, participants will undergo a repeat medical examination and liver biopsy.
1257015|NCT00063154|O1|Outcome|Pertuzumab|Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
1257120|NCT00062647|B3|Baseline|Total|Total of all reporting groups
1257016|NCT00063154|O1|Outcome|Pertuzumab|Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
1257017|NCT00063154|O1|Outcome|Pertuzumab|Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
1257018|NCT00063154|E1|Reported Event|Pertuzumab|Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
1257019|NCT00062764|B1|Baseline|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
1257020|NCT00062764|P1|Participant Flow|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
1257021|NCT00062764|O1|Outcome|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
1257022|NCT00062764|O1|Outcome|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
1257023|NCT00062764|O1|Outcome|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
1257024|NCT00062764|O1|Outcome|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
1257025|NCT00062764|O1|Outcome|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
1257026|NCT00062764|E1|Reported Event|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
1257027|NCT00062751|B6|Baseline|Total|Total of all reporting groups
1257028|NCT00062751|B5|Baseline|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257029|NCT00062751|B4|Baseline|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
1257030|NCT00062751|B3|Baseline|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257031|NCT00062751|B2|Baseline|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257032|NCT00062751|B1|Baseline|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
1257033|NCT00062751|P5|Participant Flow|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257034|NCT00062751|P4|Participant Flow|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
1257035|NCT00062751|P3|Participant Flow|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257036|NCT00062751|P2|Participant Flow|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257037|NCT00062751|P1|Participant Flow|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
1257038|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257039|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
1257040|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257041|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257042|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
1257043|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1258761|NCT00049127|O3|Outcome|Study 2 Arm B|Phase II patients not on EIACs and <=2 prior regimens
1257044|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
1257045|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257046|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257047|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
1257048|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257049|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
1257050|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257051|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257052|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
1257053|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257054|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
1257055|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257056|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257057|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
1257058|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257059|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
1257060|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257061|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257062|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
1257063|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257064|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
1257065|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257066|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257067|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
1257068|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257069|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
1257070|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257071|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257072|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
1257073|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257074|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
1257075|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257076|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257077|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
1258762|NCT00049127|O2|Outcome|Study 2 Arm A|Phase II patients on EIACs and <=2 prior regimens
1257078|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257079|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
1257247|NCT00060528|E4|Reported Event|rF-GM (10^8)|Vaccine subcutaneously with rF-GM (10^8) subcutaneously x1
1257080|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257081|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257082|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
1257083|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257084|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
1257085|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257086|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257087|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
1257088|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257089|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
1257090|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257091|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257092|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
1257093|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257094|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
1257095|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257096|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257097|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
1257098|NCT00062751|E6|Reported Event|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257099|NCT00062751|E5|Reported Event|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
1257100|NCT00062751|E4|Reported Event|After Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779). Includes events reported after the cross-over date for cross-over participants.
1257101|NCT00062751|E3|Reported Event|Let 2.5 mg Alone Prior to Cross-over to 75 mg Intermit CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent (intermit)75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779). Includes events reported prior to the cross-over date for cross-over participants.
1257102|NCT00062751|E2|Reported Event|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
1257103|NCT00062751|E1|Reported Event|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
1257104|NCT00062738|B4|Baseline|Total|Total of all reporting groups
1257105|NCT00062738|B3|Baseline|Placebo|Placebo was started at 1 pill and could be increased up to three pills.
1257106|NCT00062738|B2|Baseline|Paroxetine|Paroxetine CR was started at 12.5 mg and could be increased up to 37.5 mg.
1257107|NCT00062738|B1|Baseline|Nortriptyline|Dosing was flexible with decisions on dose being made at each visit (or between visits if the patient was having troublesome side effects) based on efficacy and tolerability. Nortriptyline was started at 25mg and could be increased up to 75 mg.
1257108|NCT00062738|P3|Participant Flow|Placebo|Placebo was started at 1 pill and could be increased up to three pills, based on investigator discretion.
1257109|NCT00062738|P2|Participant Flow|Paroxetine|Paroxetine CR was started at 12.5 mg and could be increased up to 37.5 mg, based on investigator discretion. .
1257110|NCT00062738|P1|Participant Flow|Nortriptyline|Dosing was flexible with decisions on dose being made at each visit (or between visits if the patient was having troublesome side effects) based on efficacy and tolerability. Nortriptyline was started at 25mg and could be increased up to 75 mg.
1257111|NCT00062738|O3|Outcome|Placebo|Placebo was started at 1 pill and could be increased up to three pills.
1257112|NCT00062738|O2|Outcome|Paroxetine|Paroxetine CR was started at 12.5 mg and could be increased up to 37.5 mg.
1257113|NCT00062738|O1|Outcome|Nortriptyline|Dosing was flexible with decisions on dose being made at each visit (or between visits if the patient was having troublesome side effects) based on efficacy and tolerability. Nortriptyline was started at 25mg and could be increased up to 75 mg.
1257114|NCT00062738|O3|Outcome|Placebo|
1257115|NCT00062738|O2|Outcome|Paroxetine|
1257116|NCT00062738|O1|Outcome|Nortriptyline|
1257121|NCT00062647|B2|Baseline|Standard Therapy|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy.
1257122|NCT00062647|B1|Baseline|Telavancin|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy.
1257123|NCT00062647|P2|Participant Flow|Standard Therapy|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy.
1257124|NCT00062647|P1|Participant Flow|Telavancin|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy.
1257125|NCT00062647|O2|Outcome|Standard Therapy|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy.
1257126|NCT00062647|O1|Outcome|Telavancin|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy.
1257127|NCT00062647|E2|Reported Event|Standard Therapy|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy.
1257128|NCT00062647|E1|Reported Event|Telavancin|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy.
1257129|NCT00062439|B1|Baseline|Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem|Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
1257130|NCT00062439|P1|Participant Flow|Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem|Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
1257131|NCT00062439|O1|Outcome|Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem|Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
1257132|NCT00062439|O1|Outcome|Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem|Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
1257133|NCT00062439|O1|Outcome|Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem|Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
1257134|NCT00062439|O1|Outcome|Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem|Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
1257135|NCT00062439|O3|Outcome|Consolidation Docetaxel|
1257136|NCT00062439|O2|Outcome|Surgery|
1257137|NCT00062439|O1|Outcome|Induction Cisplatin/Etoposide + XRT|
1257138|NCT00062439|E3|Reported Event|Consolidation Docetaxel|
1257139|NCT00062439|E2|Reported Event|Surgery|
1257140|NCT00062439|E1|Reported Event|Induction Cisplatin/Etoposide + XRT|
1257141|NCT00062010|B1|Baseline|IFN 13CRA Paclitaxel|Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
1257142|NCT00062010|P1|Participant Flow|IFN Alpha, 13-Cis-RA, Paclitaxel|Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
1257143|NCT00062010|O1|Outcome|IFN 13CRA Paclitaxel|Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
1257144|NCT00062010|O1|Outcome|IFN 13CRA Paclitaxel|Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
1257145|NCT00062010|O1|Outcome|IFN 13CRA Paclitaxel|Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
1257146|NCT00062010|E1|Reported Event|IFN Alpha, 13-CRA, Paclitaxel|Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
1257147|NCT00061945|B3|Baseline|Total|Total of all reporting groups
1257148|NCT00061945|B2|Baseline|Phase II - Alemtuzumab and Combination Chemotherapy|See detailed description or participant flow.
1257149|NCT00061945|B1|Baseline|Phase I - Alemtuzumab and Combination Chemotherapy|See detailed description or participant flow.
1257696|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
1257187|NCT00061373|O1|Outcome|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
1257248|NCT00060528|E3|Reported Event|rF-GM (10^7pfu)|Vaccine subcutaneously with rF-GM (10^7pfu) subcutaneously x1
1257249|NCT00060528|E2|Reported Event|Rec-hGM|Vaccine subcutaneously with Rec-hGM sucutaneously (daily x 4/vaccine)
1257150|NCT00061945|P2|Participant Flow|Phase II - Alemtuzumab and Combination Chemotherapy|COURSE 1-allopurinol (ALL) orally (PO) 4x daily (QID) d1-14, cyclophosphamide (CTX) intravenously (IV) d1, daunorubicin IV d1-3, vincristine (VCR) IV d 1,8,15 & 22, dexamethasone (DEX) PO 2x daily (BID) d 1-7 & 15-21, asparaginase (APG) subcutaneously (SC) d 5,8,11,15,18 & 22, and filgrastim (FIL) SC d 4-11. Ph+ pts imatinib (IMT) PO d 15-28 COURSE 2-methotrexate (MTX) intrathecally (IT) d1, cytarabine IV d1-3, DEX eye drops QID d 1-4, cotrimoxazole (CRT) PO BID 3x wkly d1-29 and CTX, APG & FIL as course 1. Ph+ pts IMT PO d1-28 COURSE 3-VCR IV d 1,15 & 29, MTX IV & IT d 1,15 & 19, MTX PO q6 hr d 1-2,15-16 & 29-30, mercaptopurine (6-MP) PO d1-35, leucovorin (LCV) IV d 2,16 & 30, LCV PO q6 hr d 3-4 & CRT PO BID 3x wkly d1-43. Ph+ pts IMT PO d1-42 COURSE 4-alemtuzumab 30 mg SC 3x wkly q4 wk, acyclovir PO QID q6 mo COURSE 5-course 1 COURSE 6-course 2 COURSE 7-course 3 COURSE 8-6-MP PO, VCR IV d1, DEX PO d1-5, MTX PO d 1,8,15 & 22 and CRT PO BID 3x wkly. Ph+ pts IMT PO d1-28 q24 mo
1257151|NCT00061945|P1|Participant Flow|Phase I - Alemtuzumab and Combination Chemotherapy|COURSE 1-allopurinol (ALL) orally (PO) 4x daily (QID) d1-14, cyclophosphamide (CTX) intravenously (IV) d1, daunorubicin IV d1-3, vincristine (VCR) IV d1,8,15 & 22, dexamethasone (DEX) PO 2x daily (BID) d1-7 & 15-21, asparaginase (APG) subcutaneously (SC) d5,8,11,15,18 & 22, and filgrastim (FIL) SC d4-11. Ph+ pts imatinib (IMT) PO d15-28 COURSE 2-methotrexate (MTX) intrathecally (IT) d1, cytarabine IV d1-3, DEX eye drops QID d1-4, cotrimoxazole (CRT) PO BID 3x wkly d1-29 and CTX, APG & FIL as course 1. Ph+ pts IMT PO d1-28 COURSE 3-VCR IV d1,15 & 29, MTX IV & IT d1,15 & 19, MTX PO q6 hr d1-2,15-16 & 29-30, mercaptopurine (6-MP) PO d1-35, leucovorin (LCV) IV d 2,16 & 30, LCV PO q6 hr d3-4 & CRT PO BID 3x wkly d1-43. Ph+ pts IMT PO d1-42 COURSE 4-alemtuzumab 10,20 or 30 mg SC 3x wkly q4 wk, acyclovir PO QID q6 mo COURSE 5-course 1 COURSE 6-course 2 COURSE 7-course 3 COURSE 8-6-MP PO, VCR IV d1, DEX PO d1-5, MTX PO d1,8,15 & 22 and CRT PO BID 3d wkly. Ph+ pts IMT PO d1-28 q24 mo
1257152|NCT00061945|O2|Outcome|Phase II - Alemtuzumab and Combination Chemotherapy|See detailed description
1257153|NCT00061945|O1|Outcome|Phase I - Alemtuzumab and Combination Chemotherapy|See detailed description
1257154|NCT00061945|O1|Outcome|Phase II - Alemtuzumab and Combination Chemotherapy|See detailed description or participant flow.
1257155|NCT00061945|O1|Outcome|Phase I - Alemtuzumab and Combination Chemotherapy|See detailed description or participant flow.
1257156|NCT00061945|E2|Reported Event|Phase II - Alemtuzumab and Combination Chemotherapy|See detailed description or participant flow.
1257157|NCT00061945|E1|Reported Event|Phase I - Alemtuzumab and Combination Chemotherapy|See detailed description or participant flow.
1257158|NCT00061932|B3|Baseline|Total|Total of all reporting groups
1257159|NCT00061932|B2|Baseline|Stratum 2 (Previously Treated)|"(closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.~bortezomib: Given IV~irinotecan: Given IV"
1257160|NCT00061932|B1|Baseline|Stratum 1 (Previously Untreated)|"Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV over 90 minutes on days 1 and 8.~bortezomib: Given IV~irinotecan: Given IV"
1257161|NCT00061932|P2|Participant Flow|Stratum 2 (Previously Treated)|"(closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.~bortezomib: Given IV~irinotecan: Given IV"
1257162|NCT00061932|P1|Participant Flow|Stratum 1 (Previously Untreated)|"Patients receive bortezomib IV 1.3 mg/m2 over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV 125 mg/m2 over 90 minutes on days 1 and 8.~bortezomib: Given IV (1.3 mg/m2)~irinotecan: Given IV (125 mg/m2)"
1257163|NCT00061932|O2|Outcome|Stratum 2 (Previously Treated)|"(closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.~bortezomib: Given IV~irinotecan: Given IV"
1257164|NCT00061932|O1|Outcome|Stratum 1 (Previously Untreated)|"Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV over 90 minutes on days 1 and 8.~bortezomib: Given IV~irinotecan: Given IV"
1257165|NCT00061932|E2|Reported Event|Stratum 2 (Previously Treated)|"(closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.~bortezomib: Given IV~irinotecan: Given IV"
1257166|NCT00061932|E1|Reported Event|Stratum 1 (Previously Untreated)|"Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV over 90 minutes on days 1 and 8.~bortezomib: Given IV~irinotecan: Given IV"
1257167|NCT00061893|B1|Baseline|Combination Chemotherapy|Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.
1257168|NCT00061893|P1|Participant Flow|Combination Chemotherapy|Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.
1257240|NCT00060528|O1|Outcome|Phase 2|Phase 2 patients are randomized between 4 arms: e.g. No GM, Rec-hGM, rF-GM (10^7pfu), rF-GM (10^8)with efficacy and immunological response as a primary endpoint.
1257188|NCT00061373|O2|Outcome|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
1257189|NCT00061373|O1|Outcome|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
1257169|NCT00061893|O1|Outcome|Combination Chemotherapy|Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.
1257170|NCT00061893|O1|Outcome|Combination Chemotherapy|Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.
1257171|NCT00061893|E1|Reported Event|Combination Chemotherapy|Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.
1257172|NCT00061633|B3|Baseline|Total|Total of all reporting groups
1257173|NCT00061633|B2|Baseline|Standard of Care for cSSSI|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive standard therapy, defined as vancomycin 1 Gram every 12 hours IV (intravenously) or an antistaphylococcal (semisynthetic) penicillin.
1257174|NCT00061633|B1|Baseline|Telavancin|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive telavancin 10 mg/kg/day IV (intravenously)
1257175|NCT00061633|P2|Participant Flow|Standard of Care for cSSSI|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive standard therapy, defined as vancomycin 1 Gram every 12 hours IV (intravenously) or an antistaphylococcal (semisynthetic) penicillin.
1257176|NCT00061633|P1|Participant Flow|Telavancin|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive telavancin 10 mg/kg/day IV (intravenously)
1257177|NCT00061633|O2|Outcome|Standard of Care for cSSSI|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive standard therapy, defined as vancomycin 1 Gram every 12 hours IV (intravenously) or an antistaphylococcal (semisynthetic) penicillin.
1257178|NCT00061633|O1|Outcome|Telavancin|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive telavancin 10 mg/kg/day IV (intravenously)
1257179|NCT00061633|E2|Reported Event|Standard of Care for cSSSI|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive standard therapy, defined as vancomycin 1 Gram every 12 hours IV (intravenously) or an antistaphylococcal (semisynthetic) penicillin.
1257180|NCT00061633|E1|Reported Event|Telavancin|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive telavancin 10 mg/kg/day IV (intravenously)
1257181|NCT00061373|B3|Baseline|Total|Total of all reporting groups
1257182|NCT00061373|B2|Baseline|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
1257183|NCT00061373|B1|Baseline|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
1257184|NCT00061373|P2|Participant Flow|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
1257206|NCT00061048|O1|Outcome|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
1257185|NCT00061373|P1|Participant Flow|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
1257186|NCT00061373|O2|Outcome|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
1257210|NCT00060944|B1|Baseline|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
1257190|NCT00061373|O2|Outcome|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
1257191|NCT00061373|O1|Outcome|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
1257192|NCT00061373|O2|Outcome|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
1257193|NCT00061373|O1|Outcome|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
1257194|NCT00061373|O2|Outcome|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
1257195|NCT00061373|O1|Outcome|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
1257196|NCT00061373|O2|Outcome|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
1257197|NCT00061373|O1|Outcome|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
1257198|NCT00061373|E2|Reported Event|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
1257199|NCT00061373|E1|Reported Event|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
1257200|NCT00061048|B1|Baseline|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
1257201|NCT00061048|P1|Participant Flow|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
1257202|NCT00061048|O1|Outcome|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
1257203|NCT00061048|O1|Outcome|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
1257204|NCT00061048|O1|Outcome|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
1257205|NCT00061048|O1|Outcome|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
1257836|NCT00055497|O1|Outcome|OL Adalimumab 40 mg|Open-label adalimumab 40 mg every other week or every week
1257207|NCT00061048|E1|Reported Event|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
1257208|NCT00060944|B3|Baseline|Total|Total of all reporting groups
1257209|NCT00060944|B2|Baseline|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
1257245|NCT00060528|O2|Outcome|Rec-hGM|Vaccine subcutaneously with Rec-hGM sucutaneously (daily x 4/vaccine)
1257246|NCT00060528|O1|Outcome|No GM|Vaccine subcutaneously with no GM
1257211|NCT00060944|P2|Participant Flow|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
1257212|NCT00060944|P1|Participant Flow|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
1257213|NCT00060944|O2|Outcome|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
1257214|NCT00060944|O1|Outcome|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
1257215|NCT00060944|O2|Outcome|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
1257216|NCT00060944|O1|Outcome|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
1257217|NCT00060944|O2|Outcome|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
1257218|NCT00060944|O1|Outcome|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
1257219|NCT00060944|O2|Outcome|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
1257220|NCT00060944|O1|Outcome|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
1257221|NCT00060944|O2|Outcome|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
1257222|NCT00060944|O1|Outcome|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
1257223|NCT00060944|E2|Reported Event|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
1257224|NCT00060944|E1|Reported Event|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
1257225|NCT00060840|B3|Baseline|Total|Total of all reporting groups
1257226|NCT00060840|B2|Baseline|Nitrogen|Nitrogen (N2) administered through the INOvent delivery system to subjects at 40 ppm for up to 48 hours.
1257227|NCT00060840|B1|Baseline|Inhaled Nitric Oxide|Inhaled Nitric Oxide (iNO) administered through the INOvent delivery system to subjects at 40 parts per million (ppm) for up to 48 hours
1257228|NCT00060840|P2|Participant Flow|Nitrogen|Nitrogen (N2) administered through the INOvent delivery system to subjects at 40 ppm for up to 48 hours.
1257229|NCT00060840|P1|Participant Flow|Inhaled Nitric Oxide|Inhaled Nitric Oxide (iNO) administered through the INOvent delivery system to subjects at 40 parts per million (ppm) for up to 48 hours
1257230|NCT00060840|O2|Outcome|Nitrogen|Nitrogen (N2) administered through the INOvent delivery system to subjects at 40 ppm for up to 48 hours.
1257231|NCT00060840|O1|Outcome|Inhaled Nitric Oxide|Inhaled Nitric Oxide (iNO) administered through the INOvent delivery system to subjects at 40 parts per million (ppm) for up to 48 hours
1257232|NCT00060840|E2|Reported Event|Nitrogen|Nitrogen (N2) administered through the INOvent delivery system to subjects at 40 ppm for up to 48 hours.
1257233|NCT00060840|E1|Reported Event|Inhaled Nitric Oxide|Inhaled Nitric Oxide (iNO) administered through the INOvent delivery system to subjects at 40 parts per million (ppm) for up to 48 hours
1257234|NCT00060528|B1|Baseline|Prostate Cancer Patients|Progressive Metastatic Castration Resistant Prostate Cancer
1257235|NCT00060528|P4|Participant Flow|rF-GM (10^8)|Vaccine subcutaneously with rF-GM (10^8) subcutaneously x1
1257236|NCT00060528|P3|Participant Flow|rF-GM (10^7pfu)|Vaccine subcutaneously with rF-GM (10^7pfu) subcutaneously x1
1257237|NCT00060528|P2|Participant Flow|Rec-hGM|Vaccine subcutaneously with Rec-hGM sucutaneously (daily x 4/vaccine)
1257238|NCT00060528|P1|Participant Flow|no GM|Vaccine subcutaneously with no GM
1257239|NCT00060528|O1|Outcome|Phase 2|Phase 2 patients are randomized between 4 arms: e.g. No GM, Rec-hGM, rF-GM (10^7pfu), rF-GM (10^8)with efficacy and immunological response as a primary endpoint.
1257241|NCT00060528|O1|Outcome|Phase 2|Phase 2 patients are randomized between 4 arms: e.g. No GM, Rec-hGM, rF-GM (10^7pfu), rF-GM (10^8) with efficacy and immunological response as a primary endpoint.
1257242|NCT00060528|O1|Outcome|Phase 2|Phase 2 patients are randomized between 4 arms:e.g. No GM, Rec-hGM, rF-GM (10^7pfu), rF-GM (10^8) with efficacy and immunological response as a primary endpoint.
1257243|NCT00060528|O4|Outcome|rF-GM (10^8)|Vaccine subcutaneously with rF-GM (10^8) subcutaneously x1
1257244|NCT00060528|O3|Outcome|rF-GM (10^7pfu),|Vaccine subcutaneously with rF-GM (10^7pfu) subcutaneously x1
1257250|NCT00060528|E1|Reported Event|no GM|Vaccine subcutaneously with no GM
1257251|NCT00060346|B1|Baseline|Rituximab + CHOP|"Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by:~Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily"
1257252|NCT00060346|P1|Participant Flow|Rituximab + CHOP|"Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by:~Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily"
1257253|NCT00060346|O1|Outcome|Rituximab + CHOP|"Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by:~Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily"
1257254|NCT00060346|E1|Reported Event|Rituximab + CHOP|"Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by:~Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily"
1257255|NCT00060333|B1|Baseline|Treatment (Adjuvant Radiation Therapy)|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only.
1257256|NCT00060333|P1|Participant Flow|Treatment (Adjuvant Radiation Therapy)|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only.
1257257|NCT00060333|O3|Outcome|Treatment (Adjuvant Radiation Therapy) Q03|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only. Patients completed question 3 (Q03) of the Brief Fatigue Inventory (BFI) which instructs “Please rate your fatigue (weariness, tiredness) by circling the one number that best describes your WORST level of fatigue during the past 24 hours.”
1257258|NCT00060333|O2|Outcome|Treatment (Adjuvant Radiation Therapy) Q02|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only. Patients completed question 2 (Q02) of the Brief Fatigue Inventory (BFI) which instructs “Please rate your fatigue (weariness, tiredness) by circling the one number that best describes your USUAL level of fatigue during the past 24 hours.”
1257259|NCT00060333|O1|Outcome|Treatment (Adjuvant Radiation Therapy) Q01|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only. Patients completed question 1 (Q01) of the Brief Fatigue Inventory (BFI) which instructs “Please rate your fatigue (weariness, tiredness) by circling the one number that best describes your fatigue right NOW.”
1257260|NCT00060333|O1|Outcome|Treatment (Adjuvant Radiation Therapy)|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only.
1257261|NCT00060333|O1|Outcome|Treatment (Adjuvant Radiation Therapy)|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only.
1257262|NCT00060333|O1|Outcome|Treatment (Adjuvant Radiation Therapy)|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only.
1257263|NCT00060333|O1|Outcome|Treatment (Adjuvant Radiation Therapy)|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only.
1257264|NCT00060333|O1|Outcome|Treatment (Adjuvant Radiation Therapy)|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only.
1257265|NCT00060333|E1|Reported Event|Treatment (Adjuvant Radiation Therapy)|Radiation therapy (RT) must begin within 8 weeks of surgical excision. Healing should be adequate to begin RT safely. Patients will receive a total of 30 Gy in 5 fractions of 6 Gy prescribed to Dmax, administered twice-a-week (Monday and Thursday or Tuesday and Friday) over approximately 2.5 weeks. Treatment will be administered with electrons only.
1257266|NCT00060008|B1|Baseline|18FDG-PET Scan and MR Perfusion|"Subjects will undergo MRI for quantitative (2D and 3D) evaluation of plexiform neurofibroma size, MR perfusion scan, and fludeoxyglucose (18FDG) PET scan at the time of study entry. Subjects who are treated for plexiform neurofibroma will undergo another 18FDG PET scan after one year of study entry.~fludeoxyglucose F 18~gadopentetate dimeglumine"
1257837|NCT00055497|O4|Outcome|OL Adalimumab 40 mg Eow|
1257838|NCT00055497|O3|Outcome|DB Adalimumab 40 mg Every Week (ew)|
1257267|NCT00060008|P1|Participant Flow|18FDG-PET Scan and MR Perfusion|"Subjects will undergo MRI for quantitative (2D and 3D) evaluation of plexiform neurofibroma size, MR perfusion scan, and fludeoxyglucose (18FDG) PET scan at the time of study entry. Subjects who are treated for plexiform neurofibroma will undergo another 18FDG PET scan after one year of study entry.~fludeoxyglucose F 18~gadopentetate dimeglumine"
1257268|NCT00060008|O2|Outcome|SUVmax >2|Subjects underwent MRI for quantitative (3D) evaluation of plexiform neurofibroma size and fludeoxyglucose (18FDG) PET scan at the time of study entry.
1257269|NCT00060008|O1|Outcome|SUVmax < 2|Subjects underwent MRI for quantitative (3D) evaluation of plexiform neurofibroma size and fludeoxyglucose (18FDG) PET scan at the time of study entry.
1257270|NCT00060008|E1|Reported Event|18FDG-PET Scan and MR Perfusion|"Subjects will undergo MRI for quantitative (2D and 3D) evaluation of plexiform neurofibroma size, MR perfusion scan, and fludeoxyglucose (18FDG) PET scan at the time of study entry. Subjects who are treated for plexiform neurofibroma will undergo another 18FDG PET scan after one year of study entry.~fludeoxyglucose F 18~gadopentetate dimeglumine"
1257271|NCT00059839|B3|Baseline|Total|Total of all reporting groups
1257272|NCT00059839|B2|Baseline|Consolidation (Includes Vinblastine) (Arm II)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV, methotrexate (age adjusted dosing) IT, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) IV over 1 minute on days 1, 8, and 15. In courses 4 and 5, patients receive doxorubicin hydrochloride (30 mg/m2) IV, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) as in arm II (courses 1-3). In courses 6-15, patients receive prednisone (120 mg/m2/day) and mercaptopurine (225 mg/m2) as in arm I, vinblastine sulfate (4 mg/m2) IV as in arm II (courses 1-3), and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
1257273|NCT00059839|B1|Baseline|Standard (APO) With Vincristine (Arm I)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV over 15 minutes, vincristine sulfate (1.5 mg/m2 (maximum dose 2 mg)) IV, and methotrexate intrathecally (age-adjusted dosing) (IT) on day 1 and oral prednisone (40 mg/m2/day) three times daily and oral mercaptopurine (225 mg/m2) once daily on days 1-5. In courses 4 and 5, patients receive doxorubicin (30 mg/m2), vincristine sulfate (1.5 mg/m2 (Maximum dose 2 mg)), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3. In courses 6-15, patients receive vincristine sulfate (1.5 mg/m2), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3 and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
1257274|NCT00059839|P2|Participant Flow|Consolidation (Includes Vinblastine) (Arm II)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV, methotrexate (age adjusted dosing) IT, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) IV over 1 minute on days 1, 8, and 15. In courses 4 and 5, patients receive doxorubicin hydrochloride (30 mg/m2) IV, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) as in arm II (courses 1-3). In courses 6-15, patients receive prednisone (120 mg/m2/day) and mercaptopurine (225 mg/m2) as in arm I, vinblastine sulfate (4 mg/m2) IV as in arm II (courses 1-3), and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
1257275|NCT00059839|P1|Participant Flow|Standard (APO) With Vincristine (Arm I)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV over 15 minutes, vincristine sulfate (1.5 mg/m2 (maximum dose 2 mg)) IV, and methotrexate intrathecally (age-adjusted dosing) (IT) on day 1 and oral prednisone (40 mg/m2/day) three times daily and oral mercaptopurine (225 mg/m2) once daily on days 1-5. In courses 4 and 5, patients receive doxorubicin (30 mg/m2), vincristine sulfate (1.5 mg/m2 (Maximum dose 2 mg)), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3. In courses 6-15, patients receive vincristine sulfate (1.5 mg/m2), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3 and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
1257276|NCT00059839|O2|Outcome|Consolidation (Includes Vinblastine) (Arm II)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV, methotrexate (age adjusted dosing) IT, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) IV over 1 minute on days 1, 8, and 15. In courses 4 and 5, patients receive doxorubicin hydrochloride (30 mg/m2) IV, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) as in arm II (courses 1-3). In courses 6-15, patients receive prednisone (120 mg/m2/day) and mercaptopurine (225 mg/m2) as in arm I, vinblastine sulfate (4 mg/m2) IV as in arm II (courses 1-3), and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
1257277|NCT00059839|O1|Outcome|Standard (APO) With Vincristine (Arm I)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV over 15 minutes, vincristine sulfate (1.5 mg/m2 (maximum dose 2 mg)) IV, and methotrexate intrathecally (age-adjusted dosing) (IT) on day 1 and oral prednisone (40 mg/m2/day) three times daily and oral mercaptopurine (225 mg/m2) once daily on days 1-5. In courses 4 and 5, patients receive doxorubicin (30 mg/m2), vincristine sulfate (1.5 mg/m2 (Maximum dose 2 mg)), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3. In courses 6-15, patients receive vincristine sulfate (1.5 mg/m2), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3 and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
1257278|NCT00059839|E2|Reported Event|Consolidation (Includes Vinblastine) (Arm II)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV, methotrexate (age adjusted dosing) IT, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) IV over 1 minute on days 1, 8, and 15. In courses 4 and 5, patients receive doxorubicin hydrochloride (30 mg/m2) IV, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) as in arm II (courses 1-3). In courses 6-15, patients receive prednisone (120 mg/m2/day) and mercaptopurine (225 mg/m2) as in arm I, vinblastine sulfate (4 mg/m2) IV as in arm II (courses 1-3), and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
1257296|NCT00059475|B1|Baseline|Adj-2 MART-1: 27-35|melanoma antigen recognized by T-cells (MART)-1:27-35 peptide every three weeks for four cycles (Arm I).
1257839|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Every Other Week (Eow)|
1257279|NCT00059839|E1|Reported Event|Standard (APO) With Vincristine (Arm I)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV over 15 minutes, vincristine sulfate (1.5 mg/m2 (maximum dose 2 mg)) IV, and methotrexate intrathecally (age-adjusted dosing) (IT) on day 1 and oral prednisone (40 mg/m2/day) three times daily and oral mercaptopurine (225 mg/m2) once daily on days 1-5. In courses 4 and 5, patients receive doxorubicin (30 mg/m2), vincristine sulfate (1.5 mg/m2 (Maximum dose 2 mg)), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3. In courses 6-15, patients receive vincristine sulfate (1.5 mg/m2), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3 and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
1257301|NCT00059475|P4|Participant Flow|Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm II (Arm IIA)
1257280|NCT00059787|B1|Baseline|Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.~paclitaxel: Given IV~carboplatin: Given IV~erlotinib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies"
1257281|NCT00059787|P1|Participant Flow|Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.~paclitaxel: Given IV~carboplatin: Given IV~erlotinib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies"
1257282|NCT00059787|O1|Outcome|Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.~paclitaxel: Given IV~carboplatin: Given IV~erlotinib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies"
1257283|NCT00059787|O1|Outcome|Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.~paclitaxel: Given IV~carboplatin: Given IV~erlotinib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies"
1257284|NCT00059787|O1|Outcome|Paclitaxel, Carboplatin, Erlotinib|"Carboplatin and paclitaxel IV every 21 days x 6 cycles plus oral erlotinib~paclitaxel: Given IV~carboplatin: Given IV~erlotinib: Given PO"
1257285|NCT00059787|O1|Outcome|Paclitaxel, Carboplatin, Erlotinib|"Carboplatin and paclitaxel IV every 21 days x 6 cycles plus oral erlotinib~paclitaxel: Given IV~carboplatin: Given IV~erlotinib: Given PO"
1257286|NCT00059787|O1|Outcome|Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.~paclitaxel: Given IV~carboplatin: Given IV~erlotinib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies"
1257287|NCT00059787|E1|Reported Event|Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.~paclitaxel: Given IV~carboplatin: Given IV~erlotinib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies"
1257288|NCT00059475|B9|Baseline|Total|Total of all reporting groups
1257289|NCT00059475|B8|Baseline|Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm IV (Arm IVA)
1257290|NCT00059475|B7|Baseline|Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide plus the gp100:209-217(210M) peptide emulsified together every three weeks for four cycles (Arm IV).
1257291|NCT00059475|B6|Baseline|Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm III (Arm IIIA)
1257292|NCT00059475|B5|Baseline|Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4|melanoma antigen recognized by T-cells (MART)-1:26-35(27L) peptide every three weeks for four cycles (Arm III).
1257293|NCT00059475|B4|Baseline|Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm II (Arm IIA)
1257294|NCT00059475|B3|Baseline|Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide every three weeks for four cycles (Arm II).
1257295|NCT00059475|B2|Baseline|Adj-2 HD IL-2 After MART-1: 27-35|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm I (Arm IA)
1257840|NCT00055497|O1|Outcome|DB Placebo|
1257297|NCT00059475|P8|Participant Flow|Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm IV (Arm IVA)
1257298|NCT00059475|P7|Participant Flow|Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide plus the gp100:209-217(210M) peptide emulsified together every three weeks for four cycles (Arm IV).
1257299|NCT00059475|P6|Participant Flow|Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm III (Arm IIIA)
1257300|NCT00059475|P5|Participant Flow|Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4|melanoma antigen recognized by T-cells (MART)-1:26-35(27L) peptide every three weeks for four cycles (Arm III).
1257302|NCT00059475|P3|Participant Flow|Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide every three weeks for four cycles (Arm II).
1257303|NCT00059475|P2|Participant Flow|Adj-2 HD IL-2 After MART-1: 27-35|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm I (Arm IA)
1257304|NCT00059475|P1|Participant Flow|Adj-2 MART-1: 27-35|melanoma antigen recognized by T-cells (MART)-1:27-35 peptide every three weeks for four cycles (Arm I).
1257305|NCT00059475|O4|Outcome|Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm IV (Arm IVA)
1257306|NCT00059475|O3|Outcome|Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm III (Arm IIIA)
1257307|NCT00059475|O2|Outcome|Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm II (Arm IIA)
1257308|NCT00059475|O1|Outcome|Adj-2 HD IL-2 After MART-1: 27-35|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm I (Arm IA)
1257309|NCT00059475|O8|Outcome|Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm IV (Arm IVA)
1257310|NCT00059475|O7|Outcome|Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide plus the gp100:209-217(210M) peptide emulsified together every three weeks for four cycles (Arm IV).
1257311|NCT00059475|O6|Outcome|Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm III (Arm IIIA)
1257312|NCT00059475|O5|Outcome|Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4|melanoma antigen recognized by T-cells (MART)-1:26-35(27L) peptide every three weeks for four cycles (Arm III).
1257313|NCT00059475|O4|Outcome|Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm II (Arm IIA)
1257314|NCT00059475|O3|Outcome|Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide every three weeks for four cycles (Arm II).
1257315|NCT00059475|O2|Outcome|Adj-2 HD IL-2 After MART-1: 27-35|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm I (Arm IA)
1257316|NCT00059475|O1|Outcome|Adj-2 MART-1: 27-35|melanoma antigen recognized by T-cells (MART)-1:27-35 peptide every three weeks for four cycles (Arm I).
1257317|NCT00059475|O4|Outcome|Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide plus the gp100:209-217(210M) peptide emulsified together every three weeks for four cycles (Arm IV).
1257318|NCT00059475|O3|Outcome|Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4|melanoma antigen recognized by T-cells (MART)-1:26-35(27L) peptide every three weeks for four cycles (Arm III).
1257319|NCT00059475|O2|Outcome|Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide every three weeks for four cycles (Arm II).
1257320|NCT00059475|O1|Outcome|Adj-2 MART-1: 27-35|melanoma antigen recognized by T-cells (MART)-1:27-35 peptide every three weeks for four cycles (Arm I).
1257321|NCT00059475|E8|Reported Event|Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm IV (Arm IVA)
1257322|NCT00059475|E7|Reported Event|Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide plus the gp100:209-217(210M) peptide emulsified together every three weeks for four cycles (Arm IV).
1257323|NCT00059475|E6|Reported Event|Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm III (Arm IIIA)
1257324|NCT00059475|E5|Reported Event|Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4|melanoma antigen recognized by T-cells (MART)-1:26-35(27L) peptide every three weeks for four cycles (Arm III).
1257325|NCT00059475|E4|Reported Event|Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm II (Arm IIA)
1257326|NCT00059475|E3|Reported Event|Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide every three weeks for four cycles (Arm II).
1257327|NCT00059475|E2|Reported Event|Adj-2 HD IL-2 After MART-1: 27-35|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm I (Arm IA)
1257328|NCT00059475|E1|Reported Event|Adj-2 MART-1: 27-35|melanoma antigen recognized by T-cells (MART)-1:27-35 peptide every three weeks for four cycles (Arm I).
1257329|NCT00059332|B3|Baseline|Total|Total of all reporting groups
1257330|NCT00059332|B2|Baseline|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
1257331|NCT00059332|B1|Baseline|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
1257841|NCT00055497|E4|Reported Event|OL Adalimumab 40 mg|
1257332|NCT00059332|P2|Participant Flow|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
1257333|NCT00059332|P1|Participant Flow|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
1257334|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
1257335|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
1257336|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
1257337|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
1257338|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
1257339|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
1257340|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
1257341|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
1257342|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
1257343|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
1257344|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
1257345|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
1257346|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
1257347|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
1257348|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
1257349|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
1257350|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
1257351|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
1257352|NCT00059332|E2|Reported Event|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
1257353|NCT00059332|E1|Reported Event|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
1257354|NCT00059215|B5|Baseline|Total|Total of all reporting groups
1257355|NCT00059215|B4|Baseline|Clopidogrel|Clopidogrel 300-mg oral LD at time of PCI followed by an oral 75-mg MD; taken once a day
1257356|NCT00059215|B3|Baseline|Prasugrel (CS-747) 60-mg LD/15-mg MD|Prasugrel (CS-747) 60-mg oral loading dose (LD) at time of PCI followed by 15-mg oral maintenance dose (MD), once daily, for 29-34 days
1257357|NCT00059215|B2|Baseline|Prasugrel (CS-747) 60 mg LD/10 mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days
1257358|NCT00059215|B1|Baseline|Prasugrel (CS-747) 40 mg LD/7.5 mg MD|Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of percutaneous coronary intervention (PCI) followed by 7.5-mg oral maintenance dose (MD), once daily, for 29-34 days
1257359|NCT00059215|P4|Participant Flow|Clopidogrel|Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
1257360|NCT00059215|P3|Participant Flow|Prasugrel (CS-747) 60-mg LD/15-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days
1257361|NCT00059215|P2|Participant Flow|Prasugrel (CS-747) 60-mg LD/10-mg MD|Prasugrel (CS-747) 60-mg oral loading dose (LD) at time of PCI followed by 10-mg oral maintenance dose (MD), once daily, for 29-34 days
1257530|NCT00057811|O1|Outcome|Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)|Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
1257362|NCT00059215|P1|Participant Flow|Prasugrel (CS-747) 40-mg LD/7.5 mg MD|Prasugrel (CS-747) 40 mg oral loading dose (LD) at time of percutaneous coronary intervention (PCI) followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days
1257363|NCT00059215|O5|Outcome|Prasugrel (CS-747) Combined|All evaluable patients in the 3 prasugrel (CS-747) treatment arms
1257364|NCT00059215|O4|Outcome|Clopidogrel|Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
1257365|NCT00059215|O3|Outcome|Prasugrel (CS-747) 60-mg LD/15-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days
1257366|NCT00059215|O2|Outcome|Prasugrel (CS-747) 60-mg LD/10-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days
1257367|NCT00059215|O1|Outcome|Prasugrel (CS-747) 40-mg LD/7.5-mg MD|Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of PCI followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days
1257368|NCT00059215|O5|Outcome|Prasugrel (CS-747) Combined|All evaluable patients in the 3 prasugrel (CS-747) treatment arms
1257369|NCT00059215|O4|Outcome|Clopidogrel|Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
1257370|NCT00059215|O3|Outcome|Prasugrel (CS-747) 60-mg LD/15-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days
1257371|NCT00059215|O2|Outcome|Prasugrel (CS-747) 60-mg LD/10-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days
1257372|NCT00059215|O1|Outcome|Prasugrel (CS-747) 40-mg LD/7.5-mg MD|Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of PCI followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days
1257373|NCT00059215|O5|Outcome|Prasugrel (CS-747) Combined|All evaluable patients in the 3 prasugrel (CS-747) treatment arms
1257374|NCT00059215|O4|Outcome|Clopidogrel|Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
1257375|NCT00059215|O3|Outcome|Prasugrel (CS-747) 60-mg LD/15-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days
1257376|NCT00059215|O2|Outcome|Prasugrel (CS-747) 60-mg LD/10-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days
1257377|NCT00059215|O1|Outcome|Prasugrel (CS-747) 40-mg LD/7.5-mg MD|Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of PCI followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days
1257378|NCT00059215|O5|Outcome|Prasugrel (CS-747) Combined|All evaluable patients in the 3 prasugrel (CS-747) treatment arms
1257379|NCT00059215|O4|Outcome|Clopidogrel|Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
1257380|NCT00059215|O3|Outcome|Prasugrel (CS-747) 60-mg LD/15-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days
1257381|NCT00059215|O2|Outcome|Prasugrel (CS-747) 60-mg LD/10-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days
1257382|NCT00059215|O1|Outcome|Prasugrel (CS-747) 40-mg LD/7.5-mg MD|Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of PCI followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days
1257383|NCT00059215|E4|Reported Event|Clopidogrel|Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
1257384|NCT00059215|E3|Reported Event|Prasugrel (CS-747) 60-mg LD/15-mg MD|Prasugrel (CS-747) 60-mg oral loading dose (LD) at time of PCI followed by 15-mg oral maintenance dose (MD), once daily, for 29-34 days
1257385|NCT00059215|E2|Reported Event|Prasugrel (CS-747) 60-mg LD/10 mg MD|Prasugrel (CS-747) 60-mg oral loading dose (LD) at time of PCI followed by 10-mg oral maintenance dose (MD), once daily, for 29-34 days
1257386|NCT00059215|E1|Reported Event|Prasugrel (CS-747) 40-mg LD/7.5 mg MD|Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of PCI followed by 7.5-mg oral maintenance dose (MD), once daily, for 29-34 days
1257387|NCT00058825|B1|Baseline|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
1257388|NCT00058825|P1|Participant Flow|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
1257389|NCT00058825|O2|Outcome|CLINIMACs|The CLINIMACS CD34 Reagent system was used for cell selection.
1257390|NCT00058825|O1|Outcome|Isolex|The Isolex system was used for cell selection.
1257391|NCT00058825|O2|Outcome|CLINIMACs|The CLINIMACS CD34 Reagent system was used for cell selection.
1257392|NCT00058825|O1|Outcome|Isolex|The Isolex system was used for cell selection.
1257393|NCT00058825|O1|Outcome|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
1257413|NCT00058552|O1|Outcome|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
1257842|NCT00055497|E3|Reported Event|DB Adalimumab 40 mg ew|
1257394|NCT00058825|O1|Outcome|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
1257395|NCT00058825|O1|Outcome|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
1257419|NCT00058552|O1|Outcome|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
1257848|NCT00055471|B1|Baseline|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
1257396|NCT00058825|O1|Outcome|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
1257397|NCT00058825|O1|Outcome|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
1257398|NCT00058825|O1|Outcome|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
1257399|NCT00058825|O1|Outcome|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
1257400|NCT00058825|E1|Reported Event|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
1257401|NCT00058552|B3|Baseline|Total|Total of all reporting groups
1257402|NCT00058552|B2|Baseline|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
1257403|NCT00058552|B1|Baseline|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
1257404|NCT00058552|P2|Participant Flow|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
1257405|NCT00058552|P1|Participant Flow|Pertuzumab 420 mg|Participants in this group received pertuzumab intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for Cycle 1 (1 Cycle equals to [=] 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
1257406|NCT00058552|O2|Outcome|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
1257407|NCT00058552|O1|Outcome|Pertuzumab 420 mg|Participants in this group received pertuzumab at a loading dose of 840 mg for Cycle 1, followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression (1 Cycle = 3 Weeks).
1257408|NCT00058552|O2|Outcome|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
1257409|NCT00058552|O1|Outcome|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
1257410|NCT00058552|O2|Outcome|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
1257411|NCT00058552|O1|Outcome|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
1257412|NCT00058552|O2|Outcome|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
1257484|NCT00057941|E1|Reported Event|Arm I (Anastrozole and ZD1839)|Patients receive oral anastrozole and oral gefitinib once daily on days 1-28.
1257414|NCT00058552|O2|Outcome|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
1257415|NCT00058552|O1|Outcome|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
1257416|NCT00058552|O2|Outcome|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
1257417|NCT00058552|O1|Outcome|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
1257418|NCT00058552|O2|Outcome|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
1257420|NCT00058552|E2|Reported Event|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
1257421|NCT00058552|E1|Reported Event|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
1257422|NCT00058539|B1|Baseline|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
1257423|NCT00058539|P1|Participant Flow|Pertuzumab|All the participants received a loading dose of 840 milligrams (mg) of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an intravenous (IV) infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
1257424|NCT00058539|O1|Outcome|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
1257425|NCT00058539|O1|Outcome|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
1257426|NCT00058539|O1|Outcome|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
1257427|NCT00058539|O1|Outcome|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
1257428|NCT00058539|O1|Outcome|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
1257429|NCT00058539|O1|Outcome|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
1257430|NCT00058539|O1|Outcome|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
1257431|NCT00058539|E1|Reported Event|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
1257432|NCT00058240|B5|Baseline|Total|Total of all reporting groups
1257433|NCT00058240|B4|Baseline|Dose Level 4|Dose Level 4: Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
1257434|NCT00058240|B3|Baseline|Dose Level 3|Dose Level 3: Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
1257435|NCT00058240|B2|Baseline|Dose Level 2|Dose Level 2: Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles.
1257436|NCT00058240|B1|Baseline|Dose Level 1|Dose Level 1: Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
1257437|NCT00058240|P4|Participant Flow|Dose Level 4|Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
1258751|NCT00049127|O3|Outcome|Study 2 Arm B|Phase II patients not on EIACs and <=2 prior regimens
1257438|NCT00058240|P3|Participant Flow|Dose Level 3|Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
1257439|NCT00058240|P2|Participant Flow|Dose Level 2|Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
1257440|NCT00058240|P1|Participant Flow|Dose Level 1|Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
1257441|NCT00058240|O1|Outcome|Dose Level 1, 2, 3, 4|"Dose Level 1: Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles Dose Level 2: Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles.~Dose Level 3: Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles Dose Level 4: Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles"
1257442|NCT00058240|O1|Outcome|Dose Level 4|Flavopiridol was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour beginning Dose Level 2 Cycle 1 for 6 Cycles.
1257443|NCT00058240|O4|Outcome|Dose Level 4|Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
1257444|NCT00058240|O3|Outcome|Dose Level 3|Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
1257445|NCT00058240|O2|Outcome|Dose Level 2|Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
1257446|NCT00058240|O1|Outcome|Dose Level 1|Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles
1257447|NCT00058240|E2|Reported Event|Dose Level 4|Dose Level 4: Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
1257448|NCT00058240|E1|Reported Event|Dose Levels 1-3|"Dose Level 1: Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles~Dose Level 2: Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles~Dose Level 3: Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles"
1257449|NCT00058214|B1|Baseline|Treatment (Perifosine)|"Patients receive oral perifosine 100 mg once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine at 450 mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression.~perifosine: Given orally~laboratory biomarker analysis: Correlative studies"
1257450|NCT00058214|P1|Participant Flow|Treatment (Perifosine)|"Patients receive oral perifosine 100 mg once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine at 450 mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression.~perifosine: Given orally~laboratory biomarker analysis: Correlative studies"
1257451|NCT00058214|O1|Outcome|Treatment (Perifosine)|"Patients receive oral perifosine 100 mg once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine at 450 mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression.~perifosine: Given orally~laboratory biomarker analysis: Correlative studies"
1257452|NCT00058214|O1|Outcome|Treatment (Perifosine)|"Patients receive oral perifosine 100 mg once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine at 450 mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression.~perifosine: Given orally~laboratory biomarker analysis: Correlative studies"
1257485|NCT00057876|B3|Baseline|Total|Total of all reporting groups
1257529|NCT00057811|O2|Outcome|Group C (Chemotherapy, Monoclonal Antibody Therapy)|Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
1257453|NCT00058214|E1|Reported Event|Treatment (Perifosine)|"Patients receive oral perifosine 100 mg once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine at 450 mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression.~perifosine: Given orally~laboratory biomarker analysis: Correlative studies"
1257454|NCT00058019|B3|Baseline|Total|Total of all reporting groups
1257455|NCT00058019|B2|Baseline|Cohort 2 (Chmoresistant)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
1257456|NCT00058019|B1|Baseline|Cohort 1 (Chemosensitive)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.
1257457|NCT00058019|P2|Participant Flow|Cohort 2 (Chmoresistant)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
1257506|NCT00057837|B2|Baseline|PIE (Irinotecan/Cisplatin/Etoposide)|Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10 of each cycle.
1257458|NCT00058019|P1|Participant Flow|Cohort 1 (Chemosensitive)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.
1257459|NCT00058019|O2|Outcome|Cohort 2 (Chmoresistant)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
1257460|NCT00058019|O1|Outcome|Cohort 1 (Chemosensitive)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.
1257461|NCT00058019|O2|Outcome|Cohort 2 (Chmoresistant)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
1257462|NCT00058019|O1|Outcome|Cohort 1 (Chemosensitive)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.
1257463|NCT00058019|O2|Outcome|Cohort 2 (Chmoresistant)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
1257464|NCT00058019|O1|Outcome|Cohort 1 (Chemosensitive)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.
1257465|NCT00058019|O2|Outcome|Cohort 2 (Chmoresistant)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
1257466|NCT00058019|O1|Outcome|Cohort 1 (Chemosensitive)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.
1257467|NCT00058019|O2|Outcome|Cohort 2 (Chmoresistant)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
1257468|NCT00058019|O1|Outcome|Cohort 1 (Chemosensitive)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.
1257469|NCT00058019|E1|Reported Event|Ixabeilone for Relapsed Aggressive NHL|
1257470|NCT00057954|B1|Baseline|Transplant|Reduced toxicity conditioning regimen followed by allogeneic sibling or unrelated transplant.
1257471|NCT00057954|P1|Participant Flow|Transplant|Reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) transplant.
1257472|NCT00057954|O1|Outcome|Transplant|Reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) transplant.
1257473|NCT00057954|O1|Outcome|Transplant|Reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) transplant.
1257474|NCT00057954|O1|Outcome|Transplant|Reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) transplant.
1257475|NCT00057954|E1|Reported Event|Transplant|Reduced toxicity conditioning regimen followed by allogeneic sibling or unrelated transplant.
1257476|NCT00057941|B3|Baseline|Total|Total of all reporting groups
1257477|NCT00057941|B2|Baseline|Arm II (Fulvestrant and ZD1839)|Patients receive fulvestrant intramuscularly on day 1 and oral gefitinib once daily on days 1-28.
1257478|NCT00057941|B1|Baseline|Arm I (Anastrozole and ZD1839)|Patients receive oral anastrozole and oral gefitinib once daily on days 1-28.
1257479|NCT00057941|P2|Participant Flow|Arm II (Fulvestrant and ZD1839)|Patients receive fulvestrant intramuscularly on day 1 and oral gefitinib once daily on days 1-28.
1257480|NCT00057941|P1|Participant Flow|Arm I (Anastrozole and ZD1839)|Patients receive oral anastrozole and oral gefitinib once daily on days 1-28.
1257481|NCT00057941|O2|Outcome|Fulvestrant and ZD1839|
1257482|NCT00057941|O1|Outcome|Anastrozole and ZD1839|
1257483|NCT00057941|E2|Reported Event|Arm II (Fulvestrant and ZD1839)|Patients receive fulvestrant intramuscularly on day 1 and oral gefitinib once daily on days 1-28.
1257486|NCT00057876|B2|Baseline|Gemcitabine + Radiation|"Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.~Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy."
1257487|NCT00057876|B1|Baseline|Gemcitabine|"Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.~Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles."
1257504|NCT00057863|E1|Reported Event|Treatment (Paclitaxel, Oxaliplatin)|"Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Oxaliplatin: Given IV"
1257505|NCT00057837|B3|Baseline|Total|Total of all reporting groups
1257537|NCT00057746|B4|Baseline|Total|Total of all reporting groups
1257488|NCT00057876|P2|Participant Flow|Gemcitabine + Radiation|"Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.~Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy."
1257489|NCT00057876|P1|Participant Flow|Gemcitabine|"Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.~Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles."
1257490|NCT00057876|O2|Outcome|Gemcitabine + Radiation|"Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.~Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy."
1257491|NCT00057876|O1|Outcome|Gemcitabine|"Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.~Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles."
1257492|NCT00057876|O2|Outcome|Gemcitabine + Radiation|"Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.~Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy."
1257493|NCT00057876|O1|Outcome|Gemcitabine|"Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.~Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles."
1257494|NCT00057876|O2|Outcome|Gemcitabine + Radiation|"Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.~Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy."
1257495|NCT00057876|O1|Outcome|Gemcitabine|"Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.~Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles."
1257496|NCT00057876|E2|Reported Event|Gemcitabine + Radiation|"Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.~Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy."
1257497|NCT00057876|E1|Reported Event|Gemcitabine|"Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.~Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles."
1257498|NCT00057863|B1|Baseline|Treatment (Paclitaxel, Oxaliplatin)|"Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Oxaliplatin: Given IV"
1257499|NCT00057863|P1|Participant Flow|Treatment (Paclitaxel, Oxaliplatin)|"Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Oxaliplatin: Given IV"
1257500|NCT00057863|O1|Outcome|Treatment (Paclitaxel, Oxaliplatin)|"Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Oxaliplatin: Given IV"
1257501|NCT00057863|O1|Outcome|Treatment (Paclitaxel, Oxaliplatin)|"Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Oxaliplatin: Given IV"
1257502|NCT00057863|O1|Outcome|Treatment (Paclitaxel, Oxaliplatin)|"Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Oxaliplatin: Given IV"
1257503|NCT00057863|O1|Outcome|Treatment (Paclitaxel, Oxaliplatin)|"Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Oxaliplatin: Given IV"
1257849|NCT00055471|P3|Participant Flow|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
1257507|NCT00057837|B1|Baseline|PET (Topotecan/Etoposide/Cisplatin/G-CSF)|Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.
1257508|NCT00057837|P2|Participant Flow|PIE (Irinotecan/Cisplatin/Etoposide)|Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10 of each cycle.
1257509|NCT00057837|P1|Participant Flow|PET (Topotecan/Etoposide/Cisplatin/G-CSF)|Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.
1257510|NCT00057837|O2|Outcome|PIE (Irinotecan/Cisplatin/Etoposide)|Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10 of each cycle.
1257511|NCT00057837|O1|Outcome|PET (Topotecan/Etoposide/Cisplatin/G-CSF)|Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.
1257512|NCT00057837|O2|Outcome|PIE (Irinotecan/Cisplatin/Etoposide)|Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10 of each cycle.
1257513|NCT00057837|O1|Outcome|PET (Topotecan/Etoposide/Cisplatin/G-CSF)|Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.
1257514|NCT00057837|O2|Outcome|PIE (Irinotecan/Cisplatin/Etoposide)|Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10 of each cycle.
1257515|NCT00057837|O1|Outcome|PET (Topotecan/Etoposide/Cisplatin/G-CSF)|Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.
1257516|NCT00057837|E2|Reported Event|PIE (Irinotecan/Cisplatin/Etoposide)|Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10 of each cycle.
1257517|NCT00057837|E1|Reported Event|PET (Topotecan/Etoposide/Cisplatin/G-CSF)|Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.
1257518|NCT00057811|B3|Baseline|Total|Total of all reporting groups
1257519|NCT00057811|B2|Baseline|Group C (Chemotherapy, Monoclonal Antibody Therapy)|Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
1257520|NCT00057811|B1|Baseline|Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)|Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
1257521|NCT00057811|P2|Participant Flow|Group C (Chemotherapy, Monoclonal Antibody Therapy)|Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
1257522|NCT00057811|P1|Participant Flow|Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)|Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
1257523|NCT00057811|O2|Outcome|Group C (Chemotherapy, Monoclonal Antibody Therapy)|Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
1257524|NCT00057811|O1|Outcome|Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)|Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
1257525|NCT00057811|O2|Outcome|Group C (Chemotherapy, Monoclonal Antibody Therapy)|Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
1257526|NCT00057811|O1|Outcome|Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)|Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
1257527|NCT00057811|O2|Outcome|Group C (Chemotherapy, Monoclonal Antibody Therapy)|Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
1257528|NCT00057811|O1|Outcome|Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)|Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
1257697|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
1257531|NCT00057811|E2|Reported Event|Group C (Chemotherapy, Monoclonal Antibody Therapy)|Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
1257532|NCT00057811|E1|Reported Event|Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)|Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
1257533|NCT00057785|B1|Baseline|IMRT +/- Chemotherapy|Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
1257534|NCT00057785|P1|Participant Flow|IMRT +/- Chemotherapy|Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
1257535|NCT00057785|O1|Outcome|IMRT +/- Chemotherapy|Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
1257536|NCT00057785|E1|Reported Event|IMRT +/- Chemotherapy|Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
1257538|NCT00057746|B3|Baseline|Arm III|Prophylactic cranial irradiation, 1.5 Gy FX: Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions for a total dose of 36 Gy
1257539|NCT00057746|B2|Baseline|Arm II|Prophylactic cranial irradiation, 2.0 Gy FX: Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions for a total of 36 Gy
1257540|NCT00057746|B1|Baseline|Arm I|Prophylactic cranial irradiation, 2.5 Gy FX: Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions for a total of 25 Gy
1257541|NCT00057746|P3|Participant Flow|Arm III|Prophylactic cranial irradiation, 1.5 Gy FX: Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions for a total dose of 36 Gy
1257542|NCT00057746|P2|Participant Flow|Arm II|Prophylactic cranial irradiation, 2.0 Gy FX: Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions for a total of 36 Gy
1257543|NCT00057746|P1|Participant Flow|Arm I|Prophylactic cranial irradiation, 2.5 Gy FX: Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions for a total of 25 Gy
1257544|NCT00057746|O3|Outcome|Arm III|Prophylactic cranial irradiation, 1.5 Gy FX: Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions for a total dose of 36 Gy
1257545|NCT00057746|O2|Outcome|Arm II|Prophylactic cranial irradiation, 2.0 Gy FX: Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions for a total of 36 Gy
1257546|NCT00057746|O1|Outcome|Arm I|Prophylactic cranial irradiation, 2.5 Gy FX: Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions for a total of 25 Gy
1257547|NCT00057746|E3|Reported Event|Arm III|Prophylactic cranial irradiation, 1.5 Gy FX: Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions for a total dose of 36 Gy
1257548|NCT00057746|E2|Reported Event|Arm II|Prophylactic cranial irradiation, 2.0 Gy FX: Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions for a total of 36 Gy
1257549|NCT00057746|E1|Reported Event|Arm I|Prophylactic cranial irradiation, 2.5 Gy FX: Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions for a total of 25 Gy
1257550|NCT00057681|B4|Baseline|Total|Total of all reporting groups
1257551|NCT00057681|B3|Baseline|Randomized Medication - Risperidone|Participants will receive treatment with risperidone for 8 to 16 weeks. At the initial dispensing visit, dose was 0.25mg qHS for 2 days, then 0.25mg BID for subjects <25kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects 25-50kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects >50kg. Dose was adjusted at weeks 2-3 to 0.5mg BID for subjects <25kg, 1.0mg BID for subjects 25-50kg and >50kg. Dose was adjusted at weeks 4-5 to 1.0mg BID for subjects <25kg, 1.5mg BID for subjects 25-50kg, 2.0kg BID for subjects >50kg. Dose was adjusted at weeks 6-7 to 2.0mg BID for subjects <25kg, 2.0mg AM / 3.0mg PM for subjects 25-50kg, 3.0mg BID for subjects >50kg.
1257552|NCT00057681|B2|Baseline|Randomized Medication - Divalproex Sodium|Participants will receive treatment with divalproex sodium for 8 to 16 weeks. At the initial dispensing visit, dose was 125mg qHS for 2 days, then 125mg BID for subjects <25kg; 250mg qHS for 2 days, then 125mg AM / 250mg PM for subjects 25-50kg; 250mg qHS for 2 days, then 250mg BID for subjects >50kg. Dose was adjusted to achieve blood levels of 75 ug/ml at week 1, 100-110 ug/ml at weeks 2-3, and 111-125 ug/ml at weeks 4-7.
1257553|NCT00057681|B1|Baseline|Randomized Medication - Lithium|Participants will receive treatment with lithium for 8 to 16 weeks. At the initial dispensing visit, dose was 150mg qHS for 2 days, then 150mg BID for subjects <25kg; 150mg BID for 2 days, then 300mg BID for subjects 25-50kg; 300mg BID for 2 days, then 300mg AM / 600mg PM for subjects >50kg. Dose was adjusted to achieve blood levels of 0.8 mEq/L at week 1, 0.9-1.0 mEq/L at weeks 2-3, and 1.1-1.3 mEq/L at weeks 4-7.
1257554|NCT00057681|P3|Participant Flow|Randomized Medication - Risperidone|Participants will receive treatment with risperidone for 8 to 16 weeks. At the initial dispensing visit, dose was 0.25mg qHS for 2 days, then 0.25mg BID for subjects <25kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects 25-50kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects >50kg. Dose was adjusted at weeks 2-3 to 0.5mg BID for subjects <25kg, 1.0mg BID for subjects 25-50kg and >50kg. Dose was adjusted at weeks 4-5 to 1.0mg BID for subjects <25kg, 1.5mg BID for subjects 25-50kg, 2.0kg BID for subjects >50kg. Dose was adjusted at weeks 6-7 to 2.0mg BID for subjects <25kg, 2.0mg AM / 3.0mg PM for subjects 25-50kg, 3.0mg BID for subjects >50kg.
1257555|NCT00057681|P2|Participant Flow|Randomized Medication - Divalproex Sodium|Participants will receive treatment with divalproex sodium for 8 to 16 weeks. At the initial dispensing visit, dose was 125mg qHS for 2 days, then 125mg BID for subjects <25kg; 250mg qHS for 2 days, then 125mg AM / 250mg PM for subjects 25-50kg; 250mg qHS for 2 days, then 250mg BID for subjects >50kg. Dose was adjusted to achieve blood levels of 75 ug/ml at week 1, 100-110 ug/ml at weeks 2-3, and 111-125 ug/ml at weeks 4-7.
1257556|NCT00057681|P1|Participant Flow|Randomized Medication - Lithium|Participants will receive treatment with lithium for 8 to 16 weeks. At the initial dispensing visit, dose was 150mg qHS for 2 days, then 150mg BID for subjects <25kg; 150mg BID for 2 days, then 300mg BID for subjects 25-50kg; 300mg BID for 2 days, then 300mg AM / 600mg PM for subjects >50kg. Dose was adjusted to achieve blood levels of 0.8 mEq/L at week 1, 0.9-1.0 mEq/L at weeks 2-3, and 1.1-1.3 mEq/L at weeks 4-7.
1257610|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
1257557|NCT00057681|O3|Outcome|Randomized Medication - Risperidone|Participants will receive treatment with risperidone for 8 to 16 weeks. At the initial dispensing visit, dose was 0.25mg qHS for 2 days, then 0.25mg BID for subjects <25kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects 25-50kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects >50kg. Dose was adjusted at weeks 2-3 to 0.5mg BID for subjects <25kg, 1.0mg BID for subjects 25-50kg and >50kg. Dose was adjusted at weeks 4-5 to 1.0mg BID for subjects <25kg, 1.5mg BID for subjects 25-50kg, 2.0kg BID for subjects >50kg. Dose was adjusted at weeks 6-7 to 2.0mg BID for subjects <25kg, 2.0mg AM / 3.0mg PM for subjects 25-50kg, 3.0mg BID for subjects >50kg.
1257558|NCT00057681|O2|Outcome|Randomized Medication - Divalproex Sodium|Participants will receive treatment with divalproex sodium for 8 to 16 weeks. At the initial dispensing visit, dose was 125mg qHS for 2 days, then 125mg BID for subjects <25kg; 250mg qHS for 2 days, then 125mg AM / 250mg PM for subjects 25-50kg; 250mg qHS for 2 days, then 250mg BID for subjects >50kg. Dose was adjusted to achieve blood levels of 75 ug/ml at week 1, 100-110 ug/ml at weeks 2-3, and 111-125 ug/ml at weeks 4-7.
1257559|NCT00057681|O1|Outcome|Randomized Medication - Lithium|Participants will receive treatment with lithium for 8 to 16 weeks. At the initial dispensing visit, dose was 150mg qHS for 2 days, then 150mg BID for subjects <25kg; 150mg BID for 2 days, then 300mg BID for subjects 25-50kg; 300mg BID for 2 days, then 300mg AM / 600mg PM for subjects >50kg. Dose was adjusted to achieve blood levels of 0.8 mEq/L at week 1, 0.9-1.0 mEq/L at weeks 2-3, and 1.1-1.3 mEq/L at weeks 4-7.
1257560|NCT00057681|O3|Outcome|Randomized Medication - Risperidone|Participants will receive treatment with risperidone for 8 to 16 weeks. At the initial dispensing visit, dose was 0.25mg qHS for 2 days, then 0.25mg BID for subjects <25kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects 25-50kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects >50kg. Dose was adjusted at weeks 2-3 to 0.5mg BID for subjects <25kg, 1.0mg BID for subjects 25-50kg and >50kg. Dose was adjusted at weeks 4-5 to 1.0mg BID for subjects <25kg, 1.5mg BID for subjects 25-50kg, 2.0kg BID for subjects >50kg. Dose was adjusted at weeks 6-7 to 2.0mg BID for subjects <25kg, 2.0mg AM / 3.0mg PM for subjects 25-50kg, 3.0mg BID for subjects >50kg.
1257561|NCT00057681|O2|Outcome|Randomized Medication - Divalproex Sodium|Participants will receive treatment with divalproex sodium for 8 to 16 weeks. At the initial dispensing visit, dose was 125mg qHS for 2 days, then 125mg BID for subjects <25kg; 250mg qHS for 2 days, then 125mg AM / 250mg PM for subjects 25-50kg; 250mg qHS for 2 days, then 250mg BID for subjects >50kg. Dose was adjusted to achieve blood levels of 75 ug/ml at week 1, 100-110 ug/ml at weeks 2-3, and 111-125 ug/ml at weeks 4-7.
1257562|NCT00057681|O1|Outcome|Randomized Medication - Lithium|Participants will receive treatment with lithium for 8 to 16 weeks. At the initial dispensing visit, dose was 150mg qHS for 2 days, then 150mg BID for subjects <25kg; 150mg BID for 2 days, then 300mg BID for subjects 25-50kg; 300mg BID for 2 days, then 300mg AM / 600mg PM for subjects >50kg. Dose was adjusted to achieve blood levels of 0.8 mEq/L at week 1, 0.9-1.0 mEq/L at weeks 2-3, and 1.1-1.3 mEq/L at weeks 4-7.
1257563|NCT00057681|O3|Outcome|Randomized Medication - Risperidone|Participants will receive treatment with risperidone for 8 to 16 weeks. At the initial dispensing visit, dose was 0.25mg qHS for 2 days, then 0.25mg BID for subjects <25kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects 25-50kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects >50kg. Dose was adjusted at weeks 2-3 to 0.5mg BID for subjects <25kg, 1.0mg BID for subjects 25-50kg and >50kg. Dose was adjusted at weeks 4-5 to 1.0mg BID for subjects <25kg, 1.5mg BID for subjects 25-50kg, 2.0kg BID for subjects >50kg. Dose was adjusted at weeks 6-7 to 2.0mg BID for subjects <25kg, 2.0mg AM / 3.0mg PM for subjects 25-50kg, 3.0mg BID for subjects >50kg.
1257564|NCT00057681|O2|Outcome|Randomized Medication - Divalproex Sodium|Participants will receive treatment with divalproex sodium for 8 to 16 weeks. At the initial dispensing visit, dose was 125mg qHS for 2 days, then 125mg BID for subjects <25kg; 250mg qHS for 2 days, then 125mg AM / 250mg PM for subjects 25-50kg; 250mg qHS for 2 days, then 250mg BID for subjects >50kg. Dose was adjusted to achieve blood levels of 75 ug/ml at week 1, 100-110 ug/ml at weeks 2-3, and 111-125 ug/ml at weeks 4-7.
1257565|NCT00057681|O1|Outcome|Randomized Medication - Lithium|Participants will receive treatment with lithium for 8 to 16 weeks. At the initial dispensing visit, dose was 150mg qHS for 2 days, then 150mg BID for subjects <25kg; 150mg BID for 2 days, then 300mg BID for subjects 25-50kg; 300mg BID for 2 days, then 300mg AM / 600mg PM for subjects >50kg. Dose was adjusted to achieve blood levels of 0.8 mEq/L at week 1, 0.9-1.0 mEq/L at weeks 2-3, and 1.1-1.3 mEq/L at weeks 4-7.
1257566|NCT00057681|E3|Reported Event|Randomized Medication - Risperidone|Participants will receive treatment with risperidone for 8 to 16 weeks. At the initial dispensing visit, dose was 0.25mg qHS for 2 days, then 0.25mg BID for subjects <25kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects 25-50kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects >50kg. Dose was adjusted at weeks 2-3 to 0.5mg BID for subjects <25kg, 1.0mg BID for subjects 25-50kg and >50kg. Dose was adjusted at weeks 4-5 to 1.0mg BID for subjects <25kg, 1.5mg BID for subjects 25-50kg, 2.0kg BID for subjects >50kg. Dose was adjusted at weeks 6-7 to 2.0mg BID for subjects <25kg, 2.0mg AM / 3.0mg PM for subjects 25-50kg, 3.0mg BID for subjects >50kg.
1257567|NCT00057681|E2|Reported Event|Randomized Medication - Divalproex Sodium|Participants will receive treatment with divalproex sodium for 8 to 16 weeks. At the initial dispensing visit, dose was 125mg qHS for 2 days, then 125mg BID for subjects <25kg; 250mg qHS for 2 days, then 125mg AM / 250mg PM for subjects 25-50kg; 250mg qHS for 2 days, then 250mg BID for subjects >50kg. Dose was adjusted to achieve blood levels of 75 ug/ml at week 1, 100-110 ug/ml at weeks 2-3, and 111-125 ug/ml at weeks 4-7.
1257568|NCT00057681|E1|Reported Event|Randomized Medication - Lithium|Participants will receive treatment with lithium for 8 to 16 weeks. At the initial dispensing visit, dose was 150mg qHS for 2 days, then 150mg BID for subjects <25kg; 150mg BID for 2 days, then 300mg BID for subjects 25-50kg; 300mg BID for 2 days, then 300mg AM / 600mg PM for subjects >50kg. Dose was adjusted to achieve blood levels of 0.8 mEq/L at week 1, 0.9-1.0 mEq/L at weeks 2-3, and 1.1-1.3 mEq/L at weeks 4-7.
1257569|NCT00057577|B3|Baseline|Total|Total of all reporting groups
1257570|NCT00057577|B2|Baseline|Antidepressant Medications Alone|"Participants will receive maintenance of antidepressant medication alone~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
1257843|NCT00055497|E2|Reported Event|DB Adalimumab 40 mg Eow|
1257571|NCT00057577|B1|Baseline|Cognitive Therapy Plus Antidepressant Medications|"Participants will receive antidepressant medication plus cognitive therapy~Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
1257572|NCT00057577|P2|Participant Flow|Antidepressant Medications Alone|"Participants will receive maintenance of antidepressant medication alone~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 19 months. Remitted patients are continued on medication for up to 42 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
1257573|NCT00057577|P1|Participant Flow|Cognitive Therapy Plus Antidepressant Medications|"Participants will receive antidepressant medication plus cognitive therapy~Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 19 months. Remitted patients are continued on medication for up to 42 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 19 months. Remitted patients are continued on medication for up to 42 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
1257574|NCT00057577|O2|Outcome|Antidepressant Medications Only|"Participants will receive maintenance of antidepressant medication alone~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
1257575|NCT00057577|O1|Outcome|Cognitive Therapy Plus Antidepressant Medications|"Participants will receive antidepressant medication plus cognitive therapy~Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
1257576|NCT00057577|O4|Outcome|Prior Meds Withdrawn|Patients who recovered on medication treatment were withdrawn from medications
1257577|NCT00057577|O3|Outcome|Prioir Meds Maintained|Patients who recovered on medication treatment were maintained on medications
1257578|NCT00057577|O2|Outcome|Prior CBT + Meds Withdrawn|Patients who recovered on combined treatment (CBT + Meds) were phased out of cognitive therapy and withdrawn from medications
1257579|NCT00057577|O1|Outcome|Prior CBT + Meds Maintained|Patients who recovered on combined treatment (CBT + Meds) were phased out of cognitive therapy and maintained on medications
1257580|NCT00057577|O2|Outcome|Antidepressant Medications Only|"Participants will receive maintenance of antidepressant medication alone~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
1257581|NCT00057577|O1|Outcome|Cognitive Therapy Plus Antidepressant Medications|"Participants will receive antidepressant medication plus cognitive therapy~Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
1257582|NCT00057577|O2|Outcome|Antidepressant Medications Alone|"Participants will receive maintenance of antidepressant medication alone~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
1257698|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
1257583|NCT00057577|O1|Outcome|Cognitive Therapy Plus Antidepressant Medications|"Participants will receive antidepressant medication plus cognitive therapy~Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
1257584|NCT00057577|E2|Reported Event|Antidepressant Medications Alone|"Participants will receive maintenance of antidepressant medication alone~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
1257706|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
1257585|NCT00057577|E1|Reported Event|Cognitive Therapy Plus Antidepressant Medications|"Participants will receive antidepressant medication plus cognitive therapy~Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
1257586|NCT00057551|B4|Baseline|Total|Total of all reporting groups
1257587|NCT00057551|B3|Baseline|Medication Only|"Sertraline~Escitalopram~Bupropion SR or XL~Venlafaxine XR~Mirtazapine"
1257588|NCT00057551|B2|Baseline|Brief Supportive P|Brief Supportive Psychotherapyherapy
1257589|NCT00057551|B1|Baseline|CBASP|Cognitive Behavioral Analysis System of Psychotherapy
1257590|NCT00057551|P3|Participant Flow|Medication Only|"An algorithm including Sertraline, Escitalopram~Bupropion SR or XL~Venlafaxine XR~Mirtazapine"
1257591|NCT00057551|P2|Participant Flow|Brief Supportive Psychotherapy|Brief Supportive Psychotherapyherapy
1257592|NCT00057551|P1|Participant Flow|CBASP|Cognitive Behavioral Analysis System of Psychotherapy
1257593|NCT00057551|O3|Outcome|Medication Only|"Sertraline~Escitalopram~Bupropion SR or XL~Venlafaxine XR~Mirtazapine"
1257594|NCT00057551|O2|Outcome|Brief SP|Supportive Therapy
1257595|NCT00057551|O1|Outcome|CBASP|Cognitive Behavioral Analysis System of Psychotherapy
1257596|NCT00057551|E3|Reported Event|Medication|"Sertraline~Escitalopram~Bupropion SR or XL~Venlafaxine XR~Mirtazapine"
1257597|NCT00057551|E2|Reported Event|BriefSP|Supportive Therapy
1257598|NCT00057551|E1|Reported Event|CBASP|Cognitive Behavioral Analysis System of Psychotherapy
1257599|NCT00057330|B3|Baseline|Total|Total of all reporting groups
1257600|NCT00057330|B2|Baseline|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
1257601|NCT00057330|B1|Baseline|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
1257602|NCT00057330|P2|Participant Flow|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
1257603|NCT00057330|P1|Participant Flow|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
1257604|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
1257605|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
1257606|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
1257607|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
1257608|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
1257609|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
1257699|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
1257611|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
1257612|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
1257613|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
1257614|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
1257615|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
1257616|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
1257617|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
1257618|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
1257619|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
1257620|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
1257621|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
1257622|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
1257623|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
1257624|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
1257625|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
1257626|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
1257627|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
1257628|NCT00057330|E2|Reported Event|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
1257629|NCT00057330|E1|Reported Event|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
1257630|NCT00056862|B3|Baseline|Total|Total of all reporting groups
1257631|NCT00056862|B2|Baseline|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
1257632|NCT00056862|B1|Baseline|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
1257633|NCT00056862|P2|Participant Flow|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
1257634|NCT00056862|P1|Participant Flow|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
1257657|NCT00056563|E1|Reported Event|1: Bilateral Deep Brain Stimulation|"Bilateral Deep Brain Stimulation~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
1257827|NCT00055497|O3|Outcome|DB Adalimumab 40 mg ew|
1257635|NCT00056862|O2|Outcome|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
1257636|NCT00056862|O1|Outcome|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
1257637|NCT00056862|O2|Outcome|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
1257638|NCT00056862|O1|Outcome|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
1257639|NCT00056862|O2|Outcome|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
1257640|NCT00056862|O1|Outcome|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
1257641|NCT00056862|O2|Outcome|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
1257642|NCT00056862|O1|Outcome|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
1257643|NCT00056862|O2|Outcome|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
1257644|NCT00056862|O1|Outcome|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
1257645|NCT00056862|E2|Reported Event|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
1257646|NCT00056862|E1|Reported Event|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
1257647|NCT00056563|B3|Baseline|Total|Total of all reporting groups
1257648|NCT00056563|B2|Baseline|2: Best Medical Therapy|"Best Medical Therapy~best medical therapy : Participants will initially be randomized to DBS or to 6 months of best medical therapy. BMT participants will then proceed into the surgical phase of the trial. Effective 08/05/05, randomization to the BMT arm has been discontinued since the study has sufficient information to compare the outcomes of DBS and BMT patients at 6 months."
1257649|NCT00056563|B1|Baseline|1: Bilateral Deep Brain Stimulation|"Bilateral Deep Brain Stimulation~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
1257650|NCT00056563|P2|Participant Flow|2: Best Medical Therapy|"Best Medical Therapy~best medical therapy : Participants will initially be randomized to DBS or to 6 months of"
1257651|NCT00056563|P1|Participant Flow|1: Bilateral Deep Brain Stimulation|"Bilateral Deep Brain Stimulation~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
1257652|NCT00056563|O2|Outcome|2: Best Medical Therapy|"Best Medical Therapy~best medical therapy : Participants will initially be randomized to DBS or to 6 months of"
1257653|NCT00056563|O1|Outcome|1: Bilateral Deep Brain Stimulation|"Bilateral Deep Brain Stimulation~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
1257654|NCT00056563|O2|Outcome|2: Best Medical Therapy|"Best Medical Therapy~best medical therapy : Participants will initially be randomized to DBS or to 6 months of"
1257655|NCT00056563|O1|Outcome|1: Bilateral Deep Brain Stimulation|"Bilateral Deep Brain Stimulation~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
1257656|NCT00056563|E2|Reported Event|2: Best Medical Therapy|"Best Medical Therapy~best medical therapy : Participants will initially be randomized to DBS or to 6 months of best medical therapy. BMT participants will then proceed into the surgical phase of the trial. Effective 08/05/05, randomization to the BMT arm has been discontinued since the study has sufficient information to compare the outcomes of DBS and BMT patients at 6 months."
1257658|NCT00056550|B1|Baseline|Recombinant Human Antithrombin (rhAT) Infusion|Following a baseline evaluation phase hereditary AT deficient patients(previously documented AT activity < or equal to 60% of normal)scheduled for surgery ,cesarean section or vaginal delivery were planned to be treated prophylactically with rhAT. Dosing with rhAT was to be individualized with an initial loading dose, followed by a continuous maintenance infusion dose, intended to increase and target antithrombin (AT) activity levels > 80% and < 120% of normal.
1257659|NCT00056550|P1|Participant Flow|Recombinant Human Antithrombin (rhAT) Infusion|Following a baseline evaluation phase hereditary antithrombin(AT)deficient patients scheduled for surgery, cesarean section or vaginal delivery were planned to be treated prophylactically with recombinant human antithrombin (rhAT). Dosing with recombinant human antithrombin (rhAT) was individualized with an initial intravenous loading dose, followed by a continuous intravenous infusion dose, intended to target and maintain antithrombin (AT) activity levels > 80% and < 120% of normal. The dosing objective for all study patients is maintenance of the AT activity at >80% and <120% of normal during the high risk period for thromboembolic events. Dosing and dose adjustments were based on the results of AT activity level determinations performed prior to and during the treatment.
1257707|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
1257708|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
1257660|NCT00056550|O1|Outcome|Recombinant Human Antithrombin (rhAT) Infusion|Following a baseline evaluation phase hereditary AT deficient patients scheduled for surgery ,cesarean section or vaginal delivery were planned to be treated prophylactically with rhAT. Dosing with rhAT was to be individualized with an initial loading dose, followed by a continuous maintenance infusion dose, intended to target and maintain antithrombin (AT) activity levels > 80% and < 120% of normal.
1257661|NCT00056550|O1|Outcome|Recombinant Human Antithombin (rhAT) Infusion|Following a baseline evaluation phase hereditary antithrombin (AT) deficient patients scheduled for surgery, cesarean section or vaginal delivery were planned to be treated prophylactically with recombinant human antithrombin (rhAT). Dosing with rhAT was to be individualized with an initial loading dose, followed by a continuous maintenance infusion dose, intended to target and maintain antithrombin (AT) activity levels > 80% and < 120% of normal. The dosing objective for all study patients is maintenance of the AT activity at >80 and < 120% of normal during the high risk period for thromboembolic events. Dosing and dose adjustments will be based on the results of AT activity determinations performed prior to and during treatment.
1257662|NCT00056550|E1|Reported Event|Recombinant Human Antithrombin (rhAT) Infusion|Following a baseline evaluation phase hereditary AT deficient patients(previously documented AT activity < or equal to 60% of normal)scheduled for surgery ,cesarean section or vaginal delivery were planned to be treated prophylactically with rhAT. Dosing with rhAT was to be individualized with an initial loading dose, followed by a continuous maintenance infusion dose, intended to increase and target antithrombin (AT) activity levels > 80% and < 120% of normal.
1257663|NCT00056498|B3|Baseline|Total|Total of all reporting groups
1257664|NCT00056498|B2|Baseline|Placebo|Participants assigned to placebo
1257665|NCT00056498|B1|Baseline|Risperidone|Participants assigned to risperidone
1257666|NCT00056498|P2|Participant Flow|Placebo|Participants assigned to placebo
1257667|NCT00056498|P1|Participant Flow|Risperidone|Participants assigned to risperidone
1257668|NCT00056498|O2|Outcome|Placebo|Participants assigned to placebo
1257669|NCT00056498|O1|Outcome|Risperidone|Participants assigned to risperidone
1257670|NCT00056498|E2|Reported Event|Placebo|Participants assigned to placebo
1257671|NCT00056498|E1|Reported Event|Risperidone|Participants assigned to risperidone
1257672|NCT00056472|B3|Baseline|Total|Total of all reporting groups
1257673|NCT00056472|B2|Baseline|Monotherapy|placebo plus olanzapine
1257674|NCT00056472|B1|Baseline|Pharmacotherapy|sertraline plus olanzapine
1257675|NCT00056472|P2|Participant Flow|Olanzapine Plus Placebo|5-20mg/day olanzapine plus placebo
1257676|NCT00056472|P1|Participant Flow|Sertraline Plus Olanzapine|50-200mg/day sertraline plus 5-20mg/day olanzapine
1257677|NCT00056472|O2|Outcome|Monotherapy|placebo plus olanzapine
1257678|NCT00056472|O1|Outcome|Pharmacotherapy|sertraline plus olanzapine
1257679|NCT00056472|O2|Outcome|Monotherapy|placebo plus olanzapine
1257680|NCT00056472|O1|Outcome|Pharmacotherapy|sertraline plus olanzapine
1257681|NCT00056472|O2|Outcome|Monotherapy|placebo plus olanzapine
1257682|NCT00056472|O1|Outcome|Pharmacotherapy|sertraline plus olanzapine
1257683|NCT00056472|E2|Reported Event|Monotherapy|placebo plus olanzapine
1257684|NCT00056472|E1|Reported Event|Pharmacotherapy|sertraline plus olanzapine
1257685|NCT00056407|B3|Baseline|Total|Total of all reporting groups
1257686|NCT00056407|B2|Baseline|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
1257687|NCT00056407|B1|Baseline|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
1257688|NCT00056407|P2|Participant Flow|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
1257689|NCT00056407|P1|Participant Flow|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
1257690|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
1257691|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
1257692|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
1257693|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
1257694|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
1257695|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
1257828|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Eow|
1257700|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
1257701|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
1257702|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
1257703|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
1257704|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
1257705|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
1257844|NCT00055497|E1|Reported Event|DB Placebo|
1257709|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
1257710|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
1257711|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
1257712|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
1257713|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
1257714|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
1257715|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
1257716|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
1257717|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
1257718|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
1257719|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
1257720|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
1257721|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
1257722|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
1257723|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
1257724|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
1257725|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
1257726|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
1257727|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
1257728|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
1257729|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
1257730|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
1257731|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
1257732|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
1257733|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
1257734|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
1257735|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
1257736|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
1257737|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
1257738|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
1257739|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
1257740|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
1257741|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
1257742|NCT00056407|E2|Reported Event|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
1257743|NCT00056407|E1|Reported Event|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
1257744|NCT00056316|B3|Baseline|Total|Total of all reporting groups
1257745|NCT00056316|B2|Baseline|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
1257829|NCT00055497|O1|Outcome|DB Placebo|
1257830|NCT00055497|O3|Outcome|DB Adalimumab 40 mg Every Week (ew)|
1257746|NCT00056316|B1|Baseline|Behavioral Skills Training|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
1257747|NCT00056316|P2|Participant Flow|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
1257748|NCT00056316|P1|Participant Flow|Behavioral Skills Training|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
1257749|NCT00056316|O2|Outcome|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
1257750|NCT00056316|O1|Outcome|Behavioral Skills Training|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
1257845|NCT00055471|B4|Baseline|Total|Total of all reporting groups
1257751|NCT00056316|O2|Outcome|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
1257752|NCT00056316|O1|Outcome|Behavioral Skills Training|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
1257753|NCT00056316|O2|Outcome|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
1257754|NCT00056316|O1|Outcome|Behavioral Skills Training|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
1257755|NCT00056316|O2|Outcome|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
1257756|NCT00056316|O1|Outcome|Behavioral Skills Training|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
1257757|NCT00056316|E2|Reported Event|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
1257758|NCT00056316|E1|Reported Event|Behavioral Skills Training|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
1257759|NCT00056160|B3|Baseline|Total|Total of all reporting groups
1257760|NCT00056160|B2|Baseline|Placebo/Dex|Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
1257761|NCT00056160|B1|Baseline|CC-5013/Dex|CC-5013 (lenalidomide) plus oral high-dose dexamethasone
1257762|NCT00056160|P2|Participant Flow|Placebo/Dex|Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
1257763|NCT00056160|P1|Participant Flow|CC-5013/Dex|CC-5013 (lenalidomide) plus oral high-dose dexamethasone
1257764|NCT00056160|O2|Outcome|Placebo/Dex|Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
1257765|NCT00056160|O1|Outcome|CC-5013/Dex|CC-5013 (lenalidomide) plus oral high-dose dexamethasone
1257766|NCT00056160|O2|Outcome|Placebo/Dex|Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
1257767|NCT00056160|O1|Outcome|CC-5013/Dex|CC-5013 (lenalidomide) plus oral high-dose dexamethasone
1257768|NCT00056160|O2|Outcome|Placebo/Dex|Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
1257769|NCT00056160|O1|Outcome|CC-5013/Dex|CC-5013 (lenalidomide) plus oral high-dose dexamethasone
1257770|NCT00056160|O2|Outcome|Placebo/Dex|Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
1257771|NCT00056160|O1|Outcome|CC-5013/Dex|CC-5013 (lenalidomide) plus oral high-dose dexamethasone
1257772|NCT00056160|E2|Reported Event|Placebo/Dex|Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
1257773|NCT00056160|E1|Reported Event|CC-5013/Dex|CC-5013 (lenalidomide) plus oral high-dose dexamethasone
1257774|NCT00055692|B1|Baseline|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given orally"
1257775|NCT00055692|P1|Participant Flow|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given orally"
1257776|NCT00055692|O1|Outcome|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given orally"
1257777|NCT00055692|O1|Outcome|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given orally"
1257778|NCT00055692|O2|Outcome|Treatment (Bevacizumab): 8 Weeks|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given orally"
1257779|NCT00055692|O1|Outcome|Treatment (Bevacizumab): Baseline|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given orally"
1257780|NCT00055692|O1|Outcome|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given orally"
1257781|NCT00055692|O1|Outcome|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given orally"
1257782|NCT00055692|E1|Reported Event|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given orally"
1257783|NCT00055601|B3|Baseline|Total|Total of all reporting groups
1257831|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Every Other Week (Eow)|
1257832|NCT00055497|O1|Outcome|DB Placebo|
1257784|NCT00055601|B2|Baseline|Pelvic RT + Fluorouracil + Cisplatin|Induction: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
1257785|NCT00055601|B1|Baseline|Pelvic RT + Paclitaxel + Cisplatin|Induction: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
1257786|NCT00055601|P2|Participant Flow|Pelvic RT + Fluorouracil + Cisplatin|Induction: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
1257846|NCT00055471|B3|Baseline|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
1257847|NCT00055471|B2|Baseline|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
1257787|NCT00055601|P1|Participant Flow|Pelvic RT + Paclitaxel + Cisplatin|Induction: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
1257788|NCT00055601|O2|Outcome|Pelvic RT + Fluorouracil + Cisplatin|Induction: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
1257789|NCT00055601|O1|Outcome|Pelvic RT + Paclitaxel + Cisplatin|Induction: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
1257790|NCT00055601|O2|Outcome|Pelvic RT + Fluorouracil + Cisplatin|Induction: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
1257791|NCT00055601|O1|Outcome|Pelvic RT + Paclitaxel + Cisplatin|Induction: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
1257792|NCT00055601|O2|Outcome|Pelvic RT + Fluorouracil + Cisplatin|Induction: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
1257793|NCT00055601|O1|Outcome|Pelvic RT + Paclitaxel + Cisplatin|Induction: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
1257794|NCT00055601|E2|Reported Event|Pelvic RT + Fluorouracil + Cisplatin|Induction: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
1257795|NCT00055601|E1|Reported Event|Pelvic RT + Paclitaxel + Cisplatin|Induction: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
1257796|NCT00055497|B5|Baseline|Total|Total of all reporting groups
1257797|NCT00055497|B4|Baseline|OL Adalimumab 40 mg Eow|Participants who did not continue at Week 4 are not included in Baseline summary.
1257798|NCT00055497|B3|Baseline|DB Adalimumab 40 mg Every Week|
1257799|NCT00055497|B2|Baseline|DB Adalimumab 40 mg Every Other Week (Eow)|
1257800|NCT00055497|B1|Baseline|DB Placebo|
1257801|NCT00055497|P4|Participant Flow|OL Adalimumab 40 mg|Open-label adalimumab 40 mg every other week or every week.
1257802|NCT00055497|P3|Participant Flow|DB Adalimumab 40 mg Every Week (ew)|Double-blind adalimumab 40 mg every week.
1257803|NCT00055497|P2|Participant Flow|DB Adalimumab 40 mg Every Other Week (Eow)|Double-blind adalimumab 40 mg every other week (injection received every week; placebo received when active drug not received)
1257804|NCT00055497|P1|Participant Flow|DB Placebo|Double-blind adalimumab placebo every week.
1257805|NCT00055497|O4|Outcome|OL Adalimumab 40 mg Eow|
1257806|NCT00055497|O3|Outcome|DB Adalimumab 40 mg Every Week (ew)|
1257807|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Every Other Week (Eow)|
1257808|NCT00055497|O1|Outcome|DB Placebo|
1257809|NCT00055497|O4|Outcome|OL Adalimumab 40 mg Eow|
1257810|NCT00055497|O3|Outcome|DB Adalimumab 40 mg Every Week (ew)|
1257811|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Every Other Week (Eow)|
1257812|NCT00055497|O1|Outcome|DB Placebo|
1257813|NCT00055497|O4|Outcome|OL Adalimumab 40 mg Eow|
1257814|NCT00055497|O3|Outcome|DB Adalimumab 40 mg Every Week (ew)|
1257815|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Every Other Week (Eow)|
1257816|NCT00055497|O1|Outcome|DB Placebo|
1257817|NCT00055497|O1|Outcome|OL Adalimumab 40 mg|
1257818|NCT00055497|O4|Outcome|OL Adalimumab 40 mg Eow|
1257819|NCT00055497|O3|Outcome|DB Adalimumab 40 mg Every Week (ew)|
1257820|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Every Other Week (Eow)|
1257821|NCT00055497|O1|Outcome|DB Placebo|
1257822|NCT00055497|O4|Outcome|OL Adalimumab 40 mg Eow|
1257823|NCT00055497|O3|Outcome|DB Adalimumab 40 mg ew|
1257824|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Eow|
1257825|NCT00055497|O1|Outcome|DB Placebo|
1257826|NCT00055497|O4|Outcome|OL Adalimumab 40 mg Eow|
1257850|NCT00055471|P2|Participant Flow|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
1257851|NCT00055471|P1|Participant Flow|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
1257852|NCT00055471|O3|Outcome|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
1257853|NCT00055471|O2|Outcome|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
1257854|NCT00055471|O1|Outcome|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
1257855|NCT00055471|O3|Outcome|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
1257856|NCT00055471|O2|Outcome|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
1257857|NCT00055471|O1|Outcome|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
1257858|NCT00055471|O3|Outcome|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
1257859|NCT00055471|O2|Outcome|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
1257860|NCT00055471|O1|Outcome|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
1257861|NCT00055471|O3|Outcome|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
1257862|NCT00055471|O2|Outcome|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
1257863|NCT00055471|O1|Outcome|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
1257864|NCT00055471|O3|Outcome|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
1257865|NCT00055471|O2|Outcome|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
1257866|NCT00055471|O1|Outcome|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
1257867|NCT00055471|O3|Outcome|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
1257868|NCT00055471|O2|Outcome|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
1257869|NCT00055471|O1|Outcome|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
1257870|NCT00055471|O3|Outcome|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
1257871|NCT00055471|O2|Outcome|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
1257872|NCT00055471|O1|Outcome|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
1257873|NCT00055471|E3|Reported Event|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
1257874|NCT00055471|E2|Reported Event|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
1257875|NCT00055471|E1|Reported Event|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
1257876|NCT00055237|B3|Baseline|Total|Total of all reporting groups
1257877|NCT00055237|B2|Baseline|Cohort 2: Pts With Classic Kaposi's Sarcoma (HIV-uninfected)|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
1257878|NCT00055237|B1|Baseline|Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
1257879|NCT00055237|P2|Participant Flow|Cohort 2: Pts With Classic Kaposi's Sarcoma (HIV-uninfected)|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
1257880|NCT00055237|P1|Participant Flow|Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
1257881|NCT00055237|O1|Outcome|Cohort 1 & 2: Pts With HIV-associated and Classic KS|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
1257882|NCT00055237|O1|Outcome|Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
1257883|NCT00055237|E1|Reported Event|Cohort 1 & 2: Pts With HIV-associated and Classic KS|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
1257884|NCT00054847|B3|Baseline|Total|Total of all reporting groups
1257885|NCT00054847|B2|Baseline|Radial Artery Graft|"Radial Artery~radial artery graft : Radial artery harvested from the arm is used as a conduit for CABG."
1257886|NCT00054847|B1|Baseline|Saphenous Vein Graft|"Saphenous Vein Graft~saphenous vein graft : Saphenous vein harvested from the arm is used as a conduit for CABG."
1257887|NCT00054847|P2|Participant Flow|Radial Artery Graft|"Radial Artery Graft~radial artery graft : Radial artery harvested from the arm is used as a conduit for CABG."
1257888|NCT00054847|P1|Participant Flow|Saphenous Vein Graft|"Saphenous Vein Graft~saphenous vein graft : Saphenous vein harvested from the arm is used as a conduit for CABG."
1257889|NCT00054847|O2|Outcome|Arm 2|"Radial Artery~radial artery graft: Radial artery harvested from the arm is used as a conduit for CABG."
1257890|NCT00054847|O1|Outcome|Arm 1|"Saphenous Vein Graft~saphenous vein graft: Saphenous vein harvested from the arm is used as a conduit for CABG."
1257891|NCT00054847|O2|Outcome|Arm 2|"Radial Artery~radial artery graft: Radial artery harvested from the arm is used as a conduit for CABG."
1257892|NCT00054847|O1|Outcome|Arm 1|"Saphenous Vein Graft~saphenous vein graft: Saphenous vein harvested from the arm is used as a conduit for CABG."
1257893|NCT00054847|O2|Outcome|Radial Artery Grafts|"Radial Artery Grafts~radial artery graft: Radial artery harvested from the arm is used as a conduit for CABG."
1257894|NCT00054847|O1|Outcome|Saphenous Vein Graft|"Saphenous Vein Graft~saphenous vein graft: Saphenous vein harvested from the arm is used as a conduit for CABG."
1257895|NCT00054847|O2|Outcome|Radial Artery Graft|"Radial Artery~radial artery graft : Radial artery harvested from the arm is used as a conduit for CABG."
1257896|NCT00054847|O1|Outcome|Saphenous Vein Graft|"Saphenous Vein Graft~saphenous vein graft : Saphenous vein harvested from the arm is used as a conduit for CABG."
1257897|NCT00054847|E2|Reported Event|Arm 2|"Radial Artery~radial artery graft: Radial artery harvested from the arm is used as a conduit for CABG."
1257898|NCT00054847|E1|Reported Event|Arm 1|"Saphenous Vein Graft~saphenous vein graft: Saphenous vein harvested from the arm is used as a conduit for CABG."
1257899|NCT00054717|B3|Baseline|Total|Total of all reporting groups
1257900|NCT00054717|B2|Baseline|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257901|NCT00054717|B1|Baseline|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257902|NCT00054717|P2|Participant Flow|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257903|NCT00054717|P1|Participant Flow|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257904|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257905|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257906|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257907|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257908|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257909|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257910|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257911|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257912|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257913|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257914|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257915|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257916|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257917|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257918|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257919|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257920|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257921|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257922|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257923|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257924|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257925|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257926|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257927|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257928|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257929|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257930|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257931|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257932|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257933|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257934|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257935|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257936|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257937|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257938|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257939|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257940|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257941|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257942|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257943|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257944|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257945|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257946|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257947|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257948|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257949|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257950|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257951|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257952|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257953|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257954|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257955|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257956|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257957|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257958|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257959|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257960|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257961|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257962|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257963|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257964|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257965|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257966|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257967|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257968|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257969|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257970|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257971|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257972|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257973|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257974|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257975|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257976|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257977|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257978|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257979|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257980|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257981|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257982|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257983|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257984|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257985|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257986|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257987|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258752|NCT00049127|O2|Outcome|Study 2 Arm A|Phase II patients on EIACs and <=2 prior regimens
1257988|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257989|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257990|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257991|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257992|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257993|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257994|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257995|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257996|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257997|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1257998|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1257999|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258000|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258001|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258002|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258003|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258004|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258005|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258006|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258007|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258008|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258009|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258010|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258011|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258012|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258013|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258014|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258015|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258016|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258017|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258018|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258019|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258020|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258021|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258022|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258023|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258024|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258025|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258026|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258027|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258028|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258029|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258030|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258031|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258032|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258033|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258034|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258035|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258036|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258037|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258038|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258039|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258040|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258041|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258042|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258043|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258044|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258045|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258046|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258047|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258048|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258049|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258050|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258051|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258052|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258053|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258054|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258055|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258056|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258057|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258058|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258059|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258060|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258061|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258062|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258063|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258064|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258065|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258066|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258067|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258068|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258069|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258070|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258071|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258072|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258073|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258753|NCT00049127|O1|Outcome|Study 1 Arm C|Phase I patients on EIACs and <=2 prior regimens
1258074|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258075|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258076|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258077|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258078|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258079|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258080|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258081|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258082|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258083|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258084|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258085|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258086|NCT00054717|E2|Reported Event|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
1258087|NCT00054717|E1|Reported Event|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
1258088|NCT00054704|B3|Baseline|Total|Total of all reporting groups
1258089|NCT00054704|B2|Baseline|Placebo|Placebo pills resembling 50 mg riluzole tables were dispensed either once or twice a day. Dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was be 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
1258090|NCT00054704|B1|Baseline|Riluzole|Riluzole was dispensed either once or twice a day as 50 mg tablets. Riluzole dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was be 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
1258091|NCT00054704|P2|Participant Flow|Placebo|Placebo pills resembling 50 mg riluzole tables were dispensed either once or twice a day. Dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
1258092|NCT00054704|P1|Participant Flow|Riluzole|Riluzole was dispensed either once or twice a day as 50 mg tablets. Riluzole dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
1258093|NCT00054704|O2|Outcome|Placebo|Placebo pills resembling 50 mg riluzole tables were dispensed either once or twice a day. Dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was be 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
1258094|NCT00054704|O1|Outcome|Riluzole|Riluzole was dispensed either once or twice a day as 50 mg tablets. Riluzole dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was be 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
1258114|NCT00054639|E1|Reported Event|Oblimersen + Rituximab|Oblimersen 3 mg/kg/day continuous intravenous infusion daily for 7 days on alternated weeks on week 1, 3 and 5 (days 1 through 7, 15 through 21, and 29 through 35); Rituximab 375 mg/m2 intravenous infusion for six doses on days 3, 8,15, 22, 29, and 36.
1258115|NCT00054327|B7|Baseline|Total|Total of all reporting groups
1258754|NCT00049127|O5|Outcome|Study 3 Arm E|Phase II patients not on EIACs and >2 prior regimens
1258095|NCT00054704|E2|Reported Event|Placebo|Placebo pills resembling 50 mg riluzole tables were dispensed either once or twice a day. Dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was be 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
1258096|NCT00054704|E1|Reported Event|Riluzole|Riluzole was dispensed either once or twice a day as 50 mg tablets. Riluzole dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was be 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
1258097|NCT00054691|B1|Baseline|Iressa (ZD1839)|250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
1258098|NCT00054691|P1|Participant Flow|Iressa (ZD1839)|250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
1258099|NCT00054691|O1|Outcome|Iressa (ZD1839)|250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
1258100|NCT00054691|O1|Outcome|Iressa (ZD1839)|250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
1258101|NCT00054691|E1|Reported Event|Iressa (ZD1839)|250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
1258102|NCT00054665|B1|Baseline|Arm A & B: PS-341 and PS-341 & EPOCH|"Part A: PS-341 Alone~1.3 mg/m^2 intravenous injection days 1, 4, 8, 11 every 3 weeks Part B: PS-341 & EPOCH~PS-341: level 1: 0.5 mg/m^2 intravenous (IV) days 1, 4; level 2: 1.0 mg/m^2 IV days 1, 4; level 3: 1.5 mg/m^2 IV days 1, 4; level 4: 1.7 mg/m^2 IV days 1, 4.~EPOCH: Etoposide: 50 mg/m^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion; Doxorubicin: 10 mg/m^2 day CIV days 1-4, 96 hour infusion; Vincristine: 0.4 mg/m^2 day CIV days 1-4, 96 hour infusion; Cyclophosphamide: 750 mg/m^2 day IV day 5 bolus; Prednisone: 60 mg/m^2 by mouth twice a day days 1-5; Filgrastim: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm^3. Repeat cycles every 21 days"
1258103|NCT00054665|P2|Participant Flow|Part B: PS-341 & EPOCH|PS-341 1.3 mg/m^2 intravenous bolus injection over 3-5 seconds every 3 weeks. EPOCH (etoposide 50 mg/m^2 day continuous intravenous infusion days 1-4, doxorubicin 10 mg/m^2 day continuous intravenous infusion days 1-4, vincristine 0.4 mg/m^2/day continuous intravenous infusion days 1-4, cyclophosphamide 750 mg/m^2 intravenous bolus day 5, prednisone 60 mg/m^2 by mouth days 1-5, and filgrastim 300 micrograms subcutaneously day 6 to absolute neutrophil count (ANC) recovery >/= 5000/mm^3.Per the protocol, patients who require an immediate treatment response for medical reasons will only receive part B of the protocol. This decision will be made by the principal investigator in consultation with the associate investigators.
1258104|NCT00054665|P1|Participant Flow|Part A: PS-341 Alone|1.3 mg/m^2 intravenous bolus injection over 3-5 seconds every 3 weeks.Per the protocol, patients who require an immediate treatment response for medical reasons will only receive part B of the protocol. This decision will be made by the principal investigator in consultation with the associate investigators.
1258105|NCT00054665|O2|Outcome|Part B: PS-341 & EPOCH|"Part B:~PS-341: level 1: 0.5 mg/m^2 intravenous (IV) days 1, 4; level 2: 1.0 mg/m^2 IV days 1, 4; level 3: 1.5 mg/m^2 IV days 1, 4; level 4: 1.7 mg/m^2 IV days 1, 4.~EPOCH: Etoposide: 50 mg/m^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion; Doxorubicin: 10 mg/m^2 day CIV days 1-4, 96 hour infusion; Vincristine: 0.4 mg/m^2 day CIV days 1-4, 96 hour infusion; Cyclophosphamide: 750 mg/m^2 day IV day 5 bolus; Prednisone: 60 mg/m^2 by mouth twice a day days 1-5; Filgrastim: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm^3. Repeat cycle every 21 days."
1258106|NCT00054665|O1|Outcome|Part A: PS-341 Alone|Part A: 1.3 mg/m^2 intravenous injection days 1, 4, 8, 11 every 3 weeks
1258107|NCT00054665|O2|Outcome|Part B: PS-341 & EPOCH|"PS-341: level 1: 0.5 mg/m^2 intravenous (IV) days 1, 4; level 2: 1.0 mg/m^2 IV days 1, 4; level 3: 1.5 mg/m^2 IV days 1, 4; level 4: 1.7 mg/m^2 IV days 1, 4.~EPOCH: Etoposide: 50 mg/m^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion; Doxorubicin: 10 mg/m^2 day CIV days 1-4, 96 hour infusion; Vincristine: 0.4 mg/m^2 day CIV days 1-4, 96 hour infusion; Cyclophosphamide: 750 mg/m^2 day IV day 5 bolus; Prednisone: 60 mg/m^2 by mouth twice a day days 1-5; Filgrastim: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm^3. Repeat cycle every 21 days."
1258108|NCT00054665|O1|Outcome|Part A: PS-341 Alone|1.3 mg/m^2 intravenous injection days 1, 4, 8, 11 every 3 weeks
1258109|NCT00054665|E2|Reported Event|Part B: PS-341 & EPOCH|"PS-341: level 1: 0.5 mg/m^2 intravenous (IV) days 1, 4; level 2: 1.0 mg/m^2 IV days 1, 4; level 3: 1.5 mg/m^2 IV days 1, 4; level 4: 1.7 mg/m^2 IV days 1, 4.~EPOCH: Etoposide: 50 mg/m^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion; Doxorubicin: 10 mg/m^2 day CIV days 1-4, 96 hour infusion; Vincristine: 0.4 mg/m^2 day CIV days 1-4, 96 hour infusion; Cyclophosphamide: 750 mg/m^2 day IV day 5 bolus; Prednisone: 60 mg/m^2 by mouth twice a day days 1-5; Filgrastim: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm^3. Repeat cycles every 21 days."
1258110|NCT00054665|E1|Reported Event|Part A: PS-341 Alone|PS-341 1.3 mg/m^2 intravenous injection days 1, 4, 8, 11 every 3 weeks
1258111|NCT00054639|B1|Baseline|Oblimersen + Rituximab|Oblimersen 3 mg/kg/day continuous intravenous infusion daily for 7 days on alternated weeks on week 1, 3 and 5 (days 1 through 7, 15 through 21, and 29 through 35); Rituximab 375 mg/m2 intravenous infusion for six doses on days 3, 8,15, 22, 29, and 36.
1258112|NCT00054639|P1|Participant Flow|Oblimersen + Rituximab|Oblimersen 3 mg/kg/day continuous intravenous infusion daily for 7 days on alternated weeks on week 1, 3 and 5 (days 1 through 7, 15 through 21, and 29 through 35); Rituximab 375 mg/m2 intravenous infusion for six doses on days 3, 8,15, 22, 29, and 36.
1258113|NCT00054639|O1|Outcome|Oblimersen + Rituximab|Oblimersen 3 mg/kg/day continuous intravenous infusion daily for 7 days on alternated weeks on week 1, 3 and 5 (days 1 through 7, 15 through 21, and 29 through 35); Rituximab 375 mg/m2 intravenous infusion for six doses on days 3, 8,15, 22, 29, and 36.
1258755|NCT00049127|O4|Outcome|Study 3 Arm D|Phase II patients on EIACs and >2 prior regimens
1258116|NCT00054327|B6|Baseline|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
1258117|NCT00054327|B5|Baseline|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
1258118|NCT00054327|B4|Baseline|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
1258119|NCT00054327|B3|Baseline|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
1258120|NCT00054327|B2|Baseline|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY.
1258121|NCT00054327|B1|Baseline|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
1258122|NCT00054327|P6|Participant Flow|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
1258123|NCT00054327|P5|Participant Flow|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
1258124|NCT00054327|P4|Participant Flow|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
1258125|NCT00054327|P3|Participant Flow|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
1258126|NCT00054327|P2|Participant Flow|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
1258127|NCT00054327|P1|Participant Flow|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
1258128|NCT00054327|O6|Outcome|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
1258129|NCT00054327|O5|Outcome|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
1258130|NCT00054327|O4|Outcome|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
1258131|NCT00054327|O3|Outcome|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
1258132|NCT00054327|O2|Outcome|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
1258133|NCT00054327|O1|Outcome|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
1258134|NCT00054327|O6|Outcome|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
1258135|NCT00054327|O5|Outcome|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
1258136|NCT00054327|O4|Outcome|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
1258137|NCT00054327|O3|Outcome|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
1258138|NCT00054327|O2|Outcome|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
1258139|NCT00054327|O1|Outcome|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
1258140|NCT00054327|O6|Outcome|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
1258141|NCT00054327|O5|Outcome|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
1258142|NCT00054327|O4|Outcome|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
1258143|NCT00054327|O3|Outcome|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
1258144|NCT00054327|O2|Outcome|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
1258145|NCT00054327|O1|Outcome|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
1258146|NCT00054327|O6|Outcome|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
1258147|NCT00054327|O5|Outcome|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
1258148|NCT00054327|O4|Outcome|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
1258149|NCT00054327|O3|Outcome|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
1258150|NCT00054327|O2|Outcome|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
1258151|NCT00054327|O1|Outcome|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
1258152|NCT00054327|O6|Outcome|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
1258153|NCT00054327|O5|Outcome|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
1258154|NCT00054327|O4|Outcome|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
1258155|NCT00054327|O3|Outcome|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
1258156|NCT00054327|O2|Outcome|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
1258157|NCT00054327|O1|Outcome|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
1258158|NCT00054327|E6|Reported Event|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
1258159|NCT00054327|E5|Reported Event|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
1258160|NCT00054327|E4|Reported Event|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
1258161|NCT00054327|E3|Reported Event|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
1258162|NCT00054327|E2|Reported Event|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
1258163|NCT00054327|E1|Reported Event|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
1258164|NCT00054275|B1|Baseline|Docetaxel and OSI-774|docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
1258165|NCT00054275|P1|Participant Flow|Docetaxel and OSI-774|docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
1258166|NCT00054275|O1|Outcome|Docetaxel and OSI-774|docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
1258167|NCT00054275|O1|Outcome|Docetaxel and OSI-774|docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
1258168|NCT00054275|O1|Outcome|Docetaxel and OSI-774|docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
1258169|NCT00054275|E1|Reported Event|Docetaxel and OSI-774|docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
1258170|NCT00054028|B3|Baseline|Total|Total of all reporting groups
1258171|NCT00054028|B2|Baseline|Suramin and Paclitaxel (Phase II)|Patients receive paclitaxel in combination with the target dose of suramin.
1258172|NCT00054028|B1|Baseline|Suramin and Paclitaxel (Phase I)|Patients receive low-dose suramin IV over 30 minutes and paclitaxel IV over 1 hour once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive adjusted doses of suramin until a target dose is determined. The suramin target dose is defined as the dose at which at least 5 of 6 patients achieve the target plasma concentration of 10-50 uM over the duration when paclitaxel levels are therapeutic.
1258173|NCT00054028|P1|Participant Flow|Treatment (Suramin and Paclitaxel)|"PHASE I: Patients receive low-dose suramin IV over 30 minutes and paclitaxel IV over 1 hour once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive adjusted doses of suramin until a target dose is determined. The suramin target dose is defined as the dose at which at least 5 of 6 patients achieve the target plasma concentration of 10-50 uM over the duration when paclitaxel levels are therapeutic.~PHASE II: Patients receive paclitaxel in combination with the target dose of suramin as above."
1258174|NCT00054028|O1|Outcome|Treatment (Suramin and Paclitaxel)|PHASE II: Patients receive paclitaxel in combination with the target dose of suramin the same as Phase I.
1258175|NCT00054028|O1|Outcome|Suramin and Paclitaxel|Suramin will be infused weekly over 30 minutes. Four hours after the completion of the suramin infusion the 1 hour infusion of paclitaxel will begin.
1258176|NCT00054028|O1|Outcome|Suramin and Paclitaxel|Suramin will be infused weekly over 30 minutes. Four hours after the completion of the suramin infusion the 1 hour infusion of paclitaxel will begin.
1258177|NCT00054028|E1|Reported Event|Suramin and Paclitaxel|Suramin will be infused weekly over 30 minutes. Four hours after the completion of the suramin infusion the 1 hour infusion of paclitaxel will begin.
1258178|NCT00053846|B3|Baseline|Total|Total of all reporting groups
1258179|NCT00053846|B2|Baseline|Placebo|Treatment with placebo will be one tablet taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the study period.
1258180|NCT00053846|B1|Baseline|Buspirone Hydrochloride|buspirone hydrochloride: The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period
1258181|NCT00053846|P2|Participant Flow|Placebo|Treatment with placebo will be one tablet taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the study period.
1258182|NCT00053846|P1|Participant Flow|Buspirone Hydrochloride|buspirone hydrochloride: The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period
1258183|NCT00053846|O2|Outcome|Placebo|Treatment with placebo will be one tablet taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the study period.
1258184|NCT00053846|O1|Outcome|Buspirone Hydrochloride|buspirone hydrochloride: The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period
1258185|NCT00053846|E2|Reported Event|Placebo|Treatment with placebo will be one tablet taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the study period.
1258186|NCT00053846|E1|Reported Event|Buspirone Hydrochloride|buspirone hydrochloride: The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period
1258187|NCT00053703|B4|Baseline|Total|Total of all reporting groups
1258188|NCT00053703|B3|Baseline|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
1258189|NCT00053703|B2|Baseline|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
1258190|NCT00053703|B1|Baseline|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
1258191|NCT00053703|P3|Participant Flow|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
1258192|NCT00053703|P2|Participant Flow|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
1258193|NCT00053703|P1|Participant Flow|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
1258194|NCT00053703|O3|Outcome|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
1258195|NCT00053703|O2|Outcome|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
1258196|NCT00053703|O1|Outcome|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
1258197|NCT00053703|O3|Outcome|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
1258198|NCT00053703|O2|Outcome|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
1258199|NCT00053703|O1|Outcome|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
1258200|NCT00053703|O3|Outcome|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
1258201|NCT00053703|O2|Outcome|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
1258202|NCT00053703|O1|Outcome|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
1258203|NCT00053703|O3|Outcome|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
1258204|NCT00053703|O2|Outcome|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
1258205|NCT00053703|O1|Outcome|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
1258206|NCT00053703|O3|Outcome|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
1258207|NCT00053703|O2|Outcome|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
1258208|NCT00053703|O1|Outcome|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
1258209|NCT00053703|O3|Outcome|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
1258210|NCT00053703|O2|Outcome|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
1258211|NCT00053703|O1|Outcome|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
1258212|NCT00053703|E3|Reported Event|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
1258213|NCT00053703|E2|Reported Event|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
1258214|NCT00053703|E1|Reported Event|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
1258215|NCT00053495|B6|Baseline|Total|Total of all reporting groups
1258216|NCT00053495|B5|Baseline|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
1258217|NCT00053495|B4|Baseline|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
1258218|NCT00053495|B3|Baseline|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
1258219|NCT00053495|B2|Baseline|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
1258220|NCT00053495|B1|Baseline|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
1258221|NCT00053495|P5|Participant Flow|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
1258222|NCT00053495|P4|Participant Flow|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
1258223|NCT00053495|P3|Participant Flow|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
1258224|NCT00053495|P2|Participant Flow|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
1258225|NCT00053495|P1|Participant Flow|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
1258226|NCT00053495|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
1258227|NCT00053495|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
1258228|NCT00053495|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
1258229|NCT00053495|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
1258230|NCT00053495|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
1258756|NCT00049127|O3|Outcome|Study 2 Arm B|Phase II patients not on EIACs and <=2 prior regimens
1258231|NCT00053495|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
1258232|NCT00053495|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
1258233|NCT00053495|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
1258234|NCT00053495|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
1258235|NCT00053495|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
1258236|NCT00053495|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
1258237|NCT00053495|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
1258238|NCT00053495|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
1258239|NCT00053495|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
1258240|NCT00053495|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
1258241|NCT00053495|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
1258242|NCT00053495|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
1258243|NCT00053495|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
1258244|NCT00053495|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
1258245|NCT00053495|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
1258246|NCT00053495|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
1258247|NCT00053495|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
1258248|NCT00053495|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
1258249|NCT00053495|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
1258250|NCT00053495|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
1258251|NCT00053495|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
1258252|NCT00053495|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
1258253|NCT00053495|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
1258254|NCT00053495|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
1258255|NCT00053495|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
1258256|NCT00053495|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
1258257|NCT00053495|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
1258258|NCT00053495|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
1258259|NCT00053495|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
1258260|NCT00053495|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
1258261|NCT00053495|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
1258262|NCT00053495|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
1258263|NCT00053495|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
1258264|NCT00053495|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
1258265|NCT00053495|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
1258266|NCT00053495|E5|Reported Event|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
1258267|NCT00053495|E4|Reported Event|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
1258268|NCT00053495|E3|Reported Event|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
1258269|NCT00053495|E2|Reported Event|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
1258270|NCT00053495|E1|Reported Event|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
1258271|NCT00053482|B6|Baseline|Total|Total of all reporting groups
1258272|NCT00053482|B5|Baseline|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
1258273|NCT00053482|B4|Baseline|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
1258757|NCT00049127|O2|Outcome|Study 2 Arm A|Phase II patients on EIACs and <=2 prior regimens
1258274|NCT00053482|B3|Baseline|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
1258275|NCT00053482|B2|Baseline|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
1258276|NCT00053482|B1|Baseline|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
1258277|NCT00053482|P5|Participant Flow|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
1258278|NCT00053482|P4|Participant Flow|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
1258279|NCT00053482|P3|Participant Flow|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
1258280|NCT00053482|P2|Participant Flow|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
1258281|NCT00053482|P1|Participant Flow|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
1258282|NCT00053482|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
1258283|NCT00053482|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
1258284|NCT00053482|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
1258285|NCT00053482|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
1258286|NCT00053482|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
1258287|NCT00053482|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
1258288|NCT00053482|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
1258289|NCT00053482|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
1258290|NCT00053482|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
1258291|NCT00053482|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
1258292|NCT00053482|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
1258293|NCT00053482|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
1258294|NCT00053482|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
1258295|NCT00053482|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
1258296|NCT00053482|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
1258297|NCT00053482|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
1258298|NCT00053482|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
1258299|NCT00053482|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
1258300|NCT00053482|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
1258301|NCT00053482|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
1258302|NCT00053482|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
1258303|NCT00053482|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
1258304|NCT00053482|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
1258305|NCT00053482|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
1258306|NCT00053482|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
1258307|NCT00053482|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
1258308|NCT00053482|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
1258309|NCT00053482|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
1258310|NCT00053482|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
1258311|NCT00053482|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
1258312|NCT00053482|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
1258313|NCT00053482|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
1258314|NCT00053482|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
1258315|NCT00053482|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
1258316|NCT00053482|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
1258317|NCT00053482|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
1258318|NCT00053482|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
1258319|NCT00053482|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
1258320|NCT00053482|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
1258321|NCT00053482|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
1258322|NCT00053482|E5|Reported Event|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
1258323|NCT00053482|E4|Reported Event|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
1258324|NCT00053482|E3|Reported Event|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
1258325|NCT00053482|E2|Reported Event|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
1258326|NCT00053482|E1|Reported Event|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
1258327|NCT00053417|B5|Baseline|Total|Total of all reporting groups
1258328|NCT00053417|B4|Baseline|20 mg Fampridine b.i.d.|fampridine, oral, 20 mg administered twice daily
1258329|NCT00053417|B3|Baseline|15 mg Fampridine b.i.d.|fampridine, oral, 15 mg administered twice daily
1258330|NCT00053417|B2|Baseline|10 mg Fampridine Twice a Day (b.i.d.)|fampridine, oral, 10 mg administered twice daily
1258331|NCT00053417|B1|Baseline|Placebo|Placebo control
1258332|NCT00053417|P4|Participant Flow|20 mg Fampridine b.i.d.|fampridine, oral, 20 mg administered twice daily
1258333|NCT00053417|P3|Participant Flow|15 mg Fampridine b.i.d.|fampridine, oral, 15 mg administered twice daily
1258334|NCT00053417|P2|Participant Flow|10 mg Fampridine Twice a Day (b.i.d.)|fampridine, oral, 10 mg administered twice daily
1258335|NCT00053417|P1|Participant Flow|Placebo|Placebo control
1258336|NCT00053417|O4|Outcome|20 mg Fampridine b.i.d.|fampridine, oral, 20 mg administered twice daily
1258337|NCT00053417|O3|Outcome|15 mg Fampridine b.i.d.|fampridine, oral, 15 mg administered twice daily
1258338|NCT00053417|O2|Outcome|10 mg Fampridine Twice a Day (b.i.d.)|fampridine, oral, 10 mg administered twice daily
1258339|NCT00053417|O1|Outcome|Placebo|Placebo control
1258340|NCT00053417|E4|Reported Event|20 mg Fampridine b.i.d.|fampridine, oral, 20 mg administered twice daily
1258341|NCT00053417|E3|Reported Event|15 mg Fampridine b.i.d.|fampridine, oral, 15 mg administered twice daily
1258342|NCT00053417|E2|Reported Event|10 mg Fampridine Twice a Day (b.i.d.)|fampridine, oral, 10 mg administered twice daily
1258343|NCT00053417|E1|Reported Event|Placebo|Placebo control
1258344|NCT00053365|B1|Baseline|Treatment (Irofulven)|Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
1258345|NCT00053365|P1|Participant Flow|Treatment (Irofulven)|Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
1258346|NCT00053365|O1|Outcome|Treatment (Irofulven)|Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
1258347|NCT00053365|O1|Outcome|Treatment (Irofulven)|Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
1258348|NCT00053365|E1|Reported Event|Treatment (Irofulven)|Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
1258349|NCT00053014|B1|Baseline|Treatment|patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - CSP 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); MMF 15mg/kg bid PO D0 to +27
1258350|NCT00053014|P1|Participant Flow|Treatment|patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - CSP 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); MMF 15mg/kg bid PO D0 to +27
1258351|NCT00053014|O1|Outcome|Treatment|patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - CSP 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); MMF 15mg/kg bid PO D0 to +27
1258352|NCT00053014|O1|Outcome|Treatment|patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - CSP 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); MMF 15mg/kg bid PO D0 to +27
1258353|NCT00053014|E1|Reported Event|Treatment|patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - CSP 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); MMF 15mg/kg bid PO D0 to +27
1258354|NCT00052962|B3|Baseline|Total|Total of all reporting groups
1258355|NCT00052962|B2|Baseline|Arm 2 Surgery + CHPP|"Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy~Cytoreductive surgery~continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m^2 cisplatin~post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m^2 and paclitaxel 125 mg/m^2~post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
1258356|NCT00052962|B1|Baseline|Arm 1 Surgery + Post op Chemotherapy|"Cytoreductive surgery~Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
1258467|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
1258357|NCT00052962|P2|Participant Flow|Arm 2 Surgery + CHPP|"Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy~Cytoreductive surgery~continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m^2 cisplatin~post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m^2 and paclitaxel 125 mg/m^2~post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
1258358|NCT00052962|P1|Participant Flow|Arm 1 Surgery + Post op Chemotherapy|"Cytoreductive surgery~Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
1258359|NCT00052962|O2|Outcome|Arm 2 Surgery + CHPP|"Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy~Cytoreductive surgery~continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m^2 cisplatin~post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m^2 and paclitaxel 125 mg/m^2~post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
1258360|NCT00052962|O1|Outcome|Arm 1 Surgery + Post op Chemotherapy|"Cytoreductive surgery~Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
1258361|NCT00052962|O2|Outcome|Arm 2 Surgery + CHPP|"Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy~Cytoreductive surgery~continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m^2 cisplatin~post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m^2 and paclitaxel 125 mg/m^2~post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
1258362|NCT00052962|O1|Outcome|Arm 1 Surgery + Post op Chemotherapy|"Cytoreductive surgery~Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
1258363|NCT00052962|E2|Reported Event|Arm 2 Surgery + CHPP|"Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy~Cytoreductive surgery~continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m^2 cisplatin~post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m^2 and paclitaxel 125 mg/m^2~post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
1258364|NCT00052962|E1|Reported Event|Arm 1 Surgery + Post op Chemotherapy|"Cytoreductive surgery~Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
1258365|NCT00052715|B1|Baseline|Poly-ICLC|"poly-ICLC given at dose of 20mcg/kg 3 times weeekly by intramusclular injection. days of administration were at least 2 days apart. Mon-Wed-fri~Poly-ICLC drug~poly ICLC"
1258366|NCT00052715|P1|Participant Flow|Poly-ICLC|"poly-ICLC given at dose of 20mcg/kg 3 times weeekly by intramusclular injection. days of administration were at least 2 days apart. Mon-Wed-fri~Poly-ICLC drug~poly ICLC"
1258367|NCT00052715|O1|Outcome|Poly-ICLC Newly Diagnosed GBM|"Poly-ICLC 20ug/kg 3 times a week (Monday-Wednesday-Friday) starting one week before Radiation Therapy~Intramuscular injection~Drug Poly-ICLC~poly ICLC"
1258368|NCT00052715|O1|Outcome|Poly-ICLC Newly Diagnosed GBM|"Poly-ICLC 20ug/kg 3 times a week (Monday-Wednesday-Friday) starting one week before Radiation Therapy~Intramuscular injection~Drug Poly-ICLC~poly ICLC"
1258369|NCT00052715|O1|Outcome|Poly-ICLC Newly Diagnosed GBM|"Poly-ICLC 20ug/kg 3 times a week (Monday-Wednesday-Friday) starting one week before Radiation Therapy~Intramuscular injection~Drug Poly-ICLC~poly ICLC"
1258370|NCT00052715|O1|Outcome|Poly-ICLC Newly Diagnosed GBM|"Poly-ICLC 20ug/kg 3 times a week (Monday-Wednesday-Friday) starting one week before Radiation Therapy~Intramuscular injection~Drug Poly-ICLC~poly ICLC"
1258371|NCT00052715|E1|Reported Event|Poly-ICLC|"poly-ICLC given at dose of 20mcg/kg 3 times weeekly by intramusclular injection. days of administration were at least 2 days apart. Mon-Wed-fri~Poly-ICLC drug~poly ICLC"
1258372|NCT00052429|B1|Baseline|High-Dose Radiation Therapy Plus Chemotherapy|"Phase I~Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.~Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.~Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II. Phase II~Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter."
1258373|NCT00052429|P1|Participant Flow|High-Dose Radiation Therapy Plus Chemotherapy|"Phase I~Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.~Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.~Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II. Phase II~Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter."
1258398|NCT00051636|P1|Participant Flow|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1258535|NCT00050622|O1|Outcome|No Treatment|No BMOD, No medication
1258374|NCT00052429|O1|Outcome|High-Dose Radiation Therapy Plus Chemotherapy|"Phase I~Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.~Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.~Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II. Phase II~Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter."
1258375|NCT00052429|O1|Outcome|High-Dose Radiation Therapy Plus Chemotherapy|"Phase I~Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.~Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.~Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II. Phase II~Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter."
1258376|NCT00052429|E1|Reported Event|High-Dose Radiation Therapy Plus Chemotherapy|"Phase I~Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.~Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.~Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II. Phase II~Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter."
1258377|NCT00052078|B5|Baseline|Total|Total of all reporting groups
1258378|NCT00052078|B4|Baseline|4 Placebo|"Participants will receive placebo for 12 weeks~Placebo: Participants will take placebo capsules for 12 weeks."
1258379|NCT00052078|B3|Baseline|3 Combination Setraline and CBT|"Participants will receive a combination of sertraline and cognitive behavioral therapy for 12 weeks~Sertraline: Participants will take sertraline for 12 weeks.~Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks."
1258380|NCT00052078|B2|Baseline|2 CBT|"Participants will receive cognitive behavioral therapy for 12 weeks~Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks."
1258381|NCT00052078|B1|Baseline|1 Setraline|"Participants will receive sertraline for 12 weeks~Sertraline: Participants will take sertraline for 12 weeks."
1258382|NCT00052078|P4|Participant Flow|4 Placebo|"Participants will receive placebo for 12 weeks~Placebo: Participants will take placebo capsules for 12 weeks."
1258383|NCT00052078|P3|Participant Flow|3 Combination Setraline and CBT|"Participants will receive a combination of sertraline and cognitive behavioral therapy for 12 weeks~Sertraline: Participants will take sertraline for 12 weeks.~Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks."
1258384|NCT00052078|P2|Participant Flow|2 CBT|"Participants will receive cognitive behavioral therapy for 12 weeks~Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks."
1258385|NCT00052078|P1|Participant Flow|1 Setraline|"Participants will receive sertraline for 12 weeks~Sertraline: Participants will take sertraline for 12 weeks."
1258386|NCT00052078|O4|Outcome|4 Placebo|"Participants will receive placebo for 12 weeks~Placebo: Participants will take placebo capsules for 12 weeks."
1258387|NCT00052078|O3|Outcome|3 Combination Setraline and CBT|"Participants will receive a combination of sertraline and cognitive behavioral therapy for 12 weeks~Sertraline: Participants will take sertraline for 12 weeks.~Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks."
1258388|NCT00052078|O2|Outcome|2 CBT|"Participants will receive cognitive behavioral therapy for 12 weeks~Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks."
1258389|NCT00052078|O1|Outcome|1 Setraline|"Participants will receive sertraline for 12 weeks~Sertraline: Participants will take sertraline for 12 weeks."
1258390|NCT00052078|E4|Reported Event|4 Placebo|"Participants will receive placebo for 12 weeks~Placebo: Participants will take placebo capsules for 12 weeks."
1258391|NCT00052078|E3|Reported Event|3 Combination Setraline + CBT|"Participants will receive a combination of sertraline and cognitive behavioral therapy for 12 weeks~Sertraline: Participants will take sertraline for 12 weeks.~Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks."
1258392|NCT00052078|E2|Reported Event|2 CBT|"Participants will receive cognitive behavioral therapy for 12 weeks~Cognitive Behavioral Therapy (CBT): Participants will receive CBT for 12 weeks."
1258393|NCT00052078|E1|Reported Event|1 Setraline|"Participants will receive sertraline for 12 weeks~Sertraline: Participants will take sertraline for 12 weeks."
1258394|NCT00051636|B3|Baseline|Total|Total of all reporting groups
1258395|NCT00051636|B2|Baseline|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1258396|NCT00051636|B1|Baseline|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1258397|NCT00051636|P2|Participant Flow|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1258465|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
1258582|NCT00050986|E1|Reported Event|Temozolomide and R115777|
1258399|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1258400|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1258401|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1258402|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1258403|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1258404|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1258405|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1258406|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1258407|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1258408|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1258409|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1258410|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1258411|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1258412|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1258413|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1258414|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1258415|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1258416|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1258417|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1258466|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
1258583|NCT00050960|B3|Baseline|Total|Total of all reporting groups
1258418|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1258419|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1258420|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1258421|NCT00051636|E2|Reported Event|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1258422|NCT00051636|E1|Reported Event|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
1258423|NCT00051558|B3|Baseline|Total|Total of all reporting groups
1258424|NCT00051558|B2|Baseline|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
1258425|NCT00051558|B1|Baseline|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
1258426|NCT00051558|P2|Participant Flow|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
1258427|NCT00051558|P1|Participant Flow|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
1258428|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
1258429|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
1258430|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
1258431|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
1258432|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
1258433|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
1258434|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
1258435|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
1258436|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
1258437|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
1258438|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
1258439|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
1258440|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
1258441|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
1258442|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
1258443|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
1258444|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
1258445|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
1258446|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
1258447|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
1258448|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
1258449|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
1258450|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
1258451|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
1258452|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
1258453|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
1258454|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
1258455|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
1258456|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
1258457|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
1258458|NCT00051558|E2|Reported Event|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
1258459|NCT00051558|E1|Reported Event|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
1258460|NCT00051363|B3|Baseline|Total|Total of all reporting groups
1258461|NCT00051363|B2|Baseline|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
1258462|NCT00051363|B1|Baseline|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
1258463|NCT00051363|P2|Participant Flow|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
1258464|NCT00051363|P1|Participant Flow|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
1258758|NCT00049127|O1|Outcome|Study 1 Arm C|Phase I patients on EIACs and <=2 prior regimens
1258468|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
1258469|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
1258470|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
1258471|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
1258472|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
1258473|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
1258474|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
1258475|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
1258476|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
1258477|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
1258478|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
1258479|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
1258480|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
1258481|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
1258482|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
1258483|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
1258484|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
1258485|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
1258486|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
1258487|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
1258488|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
1258489|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
1258490|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
1258491|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
1258492|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
1258493|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
1258494|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
1258495|NCT00051363|E2|Reported Event|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
1258496|NCT00051363|E1|Reported Event|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
1258497|NCT00050778|B4|Baseline|Total|Total of all reporting groups
1258498|NCT00050778|B3|Baseline|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
1258499|NCT00050778|B2|Baseline|Alemtuzumab 12 mg|Alemtuzumab 12 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
1258500|NCT00050778|B1|Baseline|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 36 months.
1258501|NCT00050778|P3|Participant Flow|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
1258502|NCT00050778|P2|Participant Flow|Alemtuzumab 12 mg|Alemtuzumab (Lemtrada™) 12 milligram per day (mg/day) was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the cluster of differentiation 4+ [CD4+] T-cell count was >=100*10^6 cells per liter).
1258503|NCT00050778|P1|Participant Flow|Interferon Beta-1a|Interferon beta-1a (Rebif®) 44 micrograms (mcg) subcutaneously 3-times weekly for 36 months.
1258504|NCT00050778|O4|Outcome|Alemtuzumab (Pooled)|Included all participants who received alemtuzumab 12 mg/day or 24 mg/day by intravenous infusion on 5 consecutive days during first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
1258759|NCT00049127|O5|Outcome|Study 3 Arm E|Phase II patients not on EIACs and >2 prior regimens
1258505|NCT00050778|O3|Outcome|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
1258506|NCT00050778|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
1258507|NCT00050778|O1|Outcome|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 36 months.
1258508|NCT00050778|O4|Outcome|Alemtuzumab (Pooled)|Included all participants who received alemtuzumab 12 mg/day or 24 mg/day by intravenous infusion on 5 consecutive days during first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
1258509|NCT00050778|O3|Outcome|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
1258510|NCT00050778|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
1258511|NCT00050778|O1|Outcome|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 36 months.
1258512|NCT00050778|O4|Outcome|Alemtuzumab (Pooled)|Included all participants who received alemtuzumab 12 mg/day or 24 mg/day by intravenous infusion on 5 consecutive days during first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
1258513|NCT00050778|O3|Outcome|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
1258514|NCT00050778|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
1258515|NCT00050778|O1|Outcome|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 36 months.
1258516|NCT00050778|O4|Outcome|Alemtuzumab (Pooled)|Included all participants who received alemtuzumab 12 mg/day or 24 mg/day by intravenous infusion on 5 consecutive days during first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
1258517|NCT00050778|O3|Outcome|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
1258518|NCT00050778|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
1258519|NCT00050778|O1|Outcome|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 36 months.
1258520|NCT00050778|O4|Outcome|Alemtuzumab (Pooled)|Included all participants who received alemtuzumab 12 mg/day or 24 mg/day by intravenous infusion on 5 consecutive days during first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
1258521|NCT00050778|O3|Outcome|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
1258522|NCT00050778|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
1258523|NCT00050778|O1|Outcome|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 36 months.
1258524|NCT00050778|E4|Reported Event|Alemtuzumab (Pooled)|Included all participants who received alemtuzumab 12 mg/day or 24 mg/day by intravenous infusion on 5 consecutive days during first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
1258525|NCT00050778|E3|Reported Event|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
1258526|NCT00050778|E2|Reported Event|Alemtuzumab 12 mg|Alemtuzumab 12 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
1258527|NCT00050778|E1|Reported Event|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 36 months.
1258528|NCT00050622|B1|Baseline|Within-Subject Treatment|All subjects completed a within-subjects crossover of 3 levels of behavior modification and 4 levels of medication.
1258529|NCT00050622|P1|Participant Flow|Within-Subject Treatment|All subjects received a within-subjects crossover of 3 levels of behavior modification, randomized in 3-week units, and 4 levels of medication, randomized on a daily basis. Thus each participant experienced all 12 combinations of No, Low, and High Intensity BMOD crossed with Placebo, 0.15 mg/kg MPH, 0.3 mg/kg MPH, and 0.6 mg/kg MPH conditions, with specific conditions changing daily.
1258530|NCT00050622|O6|Outcome|High Intensity BMOD + Medication|High Intensity BMOD + Medication (any dose)
1258531|NCT00050622|O5|Outcome|Low Intensity BMOD + Med|Low intensity behavior modification + medication (any dose)
1258532|NCT00050622|O4|Outcome|Medication Only|No BMOD + Medication (any dose)
1258533|NCT00050622|O3|Outcome|High Intensity BMOD ONly|
1258534|NCT00050622|O2|Outcome|Low Intensity BMOD Only|
1258536|NCT00050622|O12|Outcome|High Intensity BMOD + Higher Dose Medication|"0.6 mg/kg MPH, High Intensity BMOD~Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate~High Intensity BMOD: Comprehensive high-intensity STP"
1258537|NCT00050622|O11|Outcome|High Intensity BMOD + Medium Dose Medication|"0.3 mg/kg MPH, High Intensity BMOD~Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate~High Intensity BMOD: Comprehensive high-intensity STP"
1258538|NCT00050622|O10|Outcome|High Intensity BMOD + Low Dose Medication|"0.15 mg/kg MPH, High Intensity BMOD~Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate~High Intensity BMOD: Comprehensive high-intensity STP"
1258539|NCT00050622|O9|Outcome|High Intensity BMOD Only|"Placebo, High Intensity BMOD~High Intensity BMOD: Comprehensive high-intensity STP"
1258540|NCT00050622|O8|Outcome|Low Intensity BMOD + Higher Dose Medication|"0.6 mg/kg MPH, Low Intensity BMOD~Low-Intensity BMOD: Lower-intensity behavioral treatment package.~Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
1258541|NCT00050622|O7|Outcome|Low Intensity BMOD + Medium Dose Medication|"0.3 mg/kg MPH, Low Intensity BMOD~Low-Intensity BMOD: Lower-intensity behavioral treatment package.~Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
1258542|NCT00050622|O6|Outcome|Low Intensity BMOD + Low Dose Medication|"0.15 mg/kg MPH, Low Intensity BMOD~Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate~Low-Intensity BMOD: Lower-intensity behavioral treatment package."
1258543|NCT00050622|O5|Outcome|Low Intensity BMOD Only|"Placebo, Low Intensity BMOD~Low-Intensity BMOD: Lower-intensity behavioral treatment package.~Placebo"
1258544|NCT00050622|O4|Outcome|Higher Dose Medication Only|"0.6 mg/kg MPH, No BMOD~Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
1258545|NCT00050622|O3|Outcome|Medium Dose Medication Only|"0.3 mg/kg MPH, No BMOD~Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
1258546|NCT00050622|O2|Outcome|Low Dose Medication Only|"0.15 mg/kg MPH, No BMOD~Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate"
1258547|NCT00050622|O1|Outcome|No Treatment|"No Medication, No BMOD~Placebo"
1258548|NCT00050622|O12|Outcome|High Intensity BMOD + Higher Dose Medication|"0.6 mg/kg MPH, High Intensity BMOD~Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate~High Intensity BMOD: Comprehensive high-intensity STP"
1258549|NCT00050622|O11|Outcome|High Intensity BMOD + Medium Dose Medication|"0.3 mg/kg MPH, High Intensity BMOD~Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate~High Intensity BMOD: Comprehensive high-intensity STP"
1258550|NCT00050622|O10|Outcome|High Intensity BMOD + Low Dose Medication|"0.15 mg/kg MPH, High Intensity BMOD~Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate~High Intensity BMOD: Comprehensive high-intensity STP"
1258551|NCT00050622|O9|Outcome|High Intensity BMOD Only|"Placebo, High Intensity BMOD~High Intensity BMOD: Comprehensive high-intensity STP"
1258552|NCT00050622|O8|Outcome|Low Intensity BMOD + Higher Dose Medication|"0.6 mg/kg MPH, Low Intensity BMOD~Low-Intensity BMOD: Lower-intensity behavioral treatment package.~Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
1258553|NCT00050622|O7|Outcome|Low Intensity BMOD + Medium Dose Medication|"0.3 mg/kg MPH, Low Intensity BMOD~Low-Intensity BMOD: Lower-intensity behavioral treatment package.~Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
1258554|NCT00050622|O6|Outcome|Low Intensity BMOD + Low Dose Medication|"0.15 mg/kg MPH, Low Intensity BMOD~Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate~Low-Intensity BMOD: Lower-intensity behavioral treatment package."
1258555|NCT00050622|O5|Outcome|Low Intensity BMOD Only|"Placebo, Low Intensity BMOD~Low-Intensity BMOD: Lower-intensity behavioral treatment package.~Placebo"
1258556|NCT00050622|O4|Outcome|Higher Dose Medication Only|"0.6 mg/kg MPH, No BMOD~Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
1258557|NCT00050622|O3|Outcome|Medium Dose Medication Only|"0.3 mg/kg MPH, No BMOD~Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
1258558|NCT00050622|O2|Outcome|Low Dose Medication Only|"0.15 mg/kg MPH, No BMOD~Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate"
1258559|NCT00050622|O1|Outcome|No Treatment|"No Medication, No BMOD~Placebo"
1258560|NCT00050622|E4|Reported Event|Higher Dose Medication|0.6 mg/kg MPH, No BMOD
1258561|NCT00050622|E3|Reported Event|Medium Dose Medication|0.3 mg/kg MPH, No BMOD
1258562|NCT00050622|E2|Reported Event|Low Dose Medication|0.15 mg/kg MPH, No BMOD
1258563|NCT00050622|E1|Reported Event|Placebo|Placebo
1258564|NCT00051168|B1|Baseline|Travatan|Travoprost (0.004%)
1258565|NCT00051168|P1|Participant Flow|Travatan|Travoprost (0.004%)
1258566|NCT00051168|O1|Outcome|Travatan|Travoprost (0.004%)
1258567|NCT00051168|E1|Reported Event|Travatan|Travoprost (0.004%)
1258568|NCT00051025|B3|Baseline|Total|Total of all reporting groups
1258569|NCT00051025|B2|Baseline|Ontak 8-Course Group|Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
1258570|NCT00051025|B1|Baseline|Ontak 4-Course Group|Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
1258571|NCT00051025|P2|Participant Flow|Ontak 8-Course Group|Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
1258572|NCT00051025|P1|Participant Flow|Ontak 4-Course Group|Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
1258573|NCT00051025|O2|Outcome|Ontak 8-Course Group|Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
1258574|NCT00051025|O1|Outcome|Ontak 4-Course Group|Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
1258575|NCT00051025|O2|Outcome|Ontak 8-Course Group|Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
1258576|NCT00051025|O1|Outcome|Ontak 4-Course Group|Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
1258577|NCT00051025|E2|Reported Event|Ontak 8-Course Group|Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
1258578|NCT00051025|E1|Reported Event|Ontak 4-Course Group|Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
1258579|NCT00050986|B1|Baseline|Temozolomide and R115777|
1258580|NCT00050986|P1|Participant Flow|Temozolomide and R115777|
1258581|NCT00050986|O1|Outcome|Temozolomide and R115777|
1258584|NCT00050960|B2|Baseline|Carboplatin and Paclitaxel|carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks.
1258585|NCT00050960|B1|Baseline|Bexarotene With Carboplatin and Paclitaxel|bexarotene capsules (400 mg/m^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.
1258586|NCT00050960|P2|Participant Flow|Carboplatin and Paclitaxel|carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks.
1258587|NCT00050960|P1|Participant Flow|Bexarotene With Carboplatin and Paclitaxel|bexarotene capsules (400 mg/m^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.
1258588|NCT00050960|O2|Outcome|Carboplatin and Paclitaxel|carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks.
1258589|NCT00050960|O1|Outcome|Bexarotene With Carboplatin and Paclitaxel|bexarotene capsules (400 mg/m^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.
1258590|NCT00050960|E2|Reported Event|Carboplatin and Paclitaxel|carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks.
1258591|NCT00050960|E1|Reported Event|Bexarotene With Carboplatin and Paclitaxel|bexarotene capsules (400 mg/m^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.
1258592|NCT00050167|B3|Baseline|Total|Total of all reporting groups
1258593|NCT00050167|B2|Baseline|Docetaxel and Capecitabine (DX)|Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
1258594|NCT00050167|B1|Baseline|Weekly Paclitaxel (WP)|Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles
1258595|NCT00050167|P2|Participant Flow|Docetaxel and Capecitabine (DX)|Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
1258596|NCT00050167|P1|Participant Flow|Weekly Paclitaxel (WP)|Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles
1258597|NCT00050167|O2|Outcome|Docetaxel and Capecitabine (DX)|Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
1258598|NCT00050167|O1|Outcome|Weekly Paclitaxel (WP)|Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles
1258599|NCT00050167|E2|Reported Event|Docetaxel and Capecitabine (DX)|Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
1258600|NCT00050167|E1|Reported Event|Weekly Paclitaxel (WP)|Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles
1258601|NCT00050089|B5|Baseline|Total|Total of all reporting groups
1258602|NCT00050089|B4|Baseline|ARDFP + Mega ART|Antiretroviral Treatment Interruption and Intensive ART
1258603|NCT00050089|B3|Baseline|ARDFP + Standard ART|Antiretroviral Treatment Interruption and Standard ART
1258604|NCT00050089|B2|Baseline|No ARDFP + Mega ART|Intensive Antiretroviral Treatment regimen
1258605|NCT00050089|B1|Baseline|No ARDFP + Standard ART|Standard Antiretroviral Treatment regimen
1258606|NCT00050089|P4|Participant Flow|ARDFP+Mega-ART|"Antiretroviral Drug-Free Period (ARDFP) and Mega-ART~Intended duration of ARDFP: 12 weeks Mega-ART: 5 or more anti-HIV drugs"
1258607|NCT00050089|P3|Participant Flow|ARDFP+Standard-ART|"Antiretroviral Drug-Free Period (ARDFP) and Standard-ART~Intended duration of ARDFP: 12 week2 Standard-ART: up to 4 anti-HIV drugs"
1258608|NCT00050089|P2|Participant Flow|No ARDFP+Mega-ART|"No Antiretroviral Drug-Free Period (No ARDFP) and Mega-ART~Mega-ART: 5 or more anti-HIV drugs"
1258609|NCT00050089|P1|Participant Flow|No ARDFP+Standard-ART|"No Antiretroviral Drug-Free Period (No ARDFP) and Standard-ART~Standard-ART: up to 4 anti-HIV drugs"
1258610|NCT00050089|O2|Outcome|No ARDFP|This includes participants randomized to No ARDFP (No ARDFP+Standard-ART or No ARDFP+Mega-ART)
1258611|NCT00050089|O1|Outcome|ARDFP|This includes participants randomized to ARDFP (ARDFP+Standard-ART or ARDFP+Mega-ART)
1258612|NCT00050089|O2|Outcome|Mega-ART|This includes participants randomized to Mega-ART (No ARDFP+Mega-ART or ARDFP+Mega-ART)
1258613|NCT00050089|O1|Outcome|Standard-ART|This includes participants randomized to Standard-ART (No ARDFP+Standard-ART or ARDFP+Standard-ART)
1258614|NCT00050089|O4|Outcome|ARDFP + Mega ART|Intensive ART following ART interruption
1258615|NCT00050089|O3|Outcome|ARDFP + Standard ART|Standard ART regimen following ART interruption
1258616|NCT00050089|O2|Outcome|No ARDFP + Mega ART|Intensive ART regimen, with no prior ART interruption
1258617|NCT00050089|O1|Outcome|No ARDFP + Standard ART|Standard ART regimen, with no prior ART interruption
1258618|NCT00050089|O2|Outcome|No ARDFP|This includes participants randomized to No ARDFP (No ARDFP+Standard-ART or No ARDFP+Mega-ART)
1258619|NCT00050089|O1|Outcome|ARDFP|This includes participants randomized to ARDFP (ARDFP+Standard-ART or ARDFP+Mega-ART)
1258620|NCT00050089|O2|Outcome|Mega-ART|This includes participants randomized to Mega-ART (No ARDFP+Mega-ART or ARDFP+Mega-ART)
1258621|NCT00050089|O1|Outcome|Standard-ART|This includes participants randomized to Standard-ART (No ARDFP+Standard-ART or ARDFP+Standard-ART)
1258622|NCT00050089|E4|Reported Event|ARDFP + Mega ART|Antiretroviral Treatment Interruption and Intensive ART
1258623|NCT00050089|E3|Reported Event|ARDFP + Standard ART|Antiretroviral Treatment Interruption and Standard ART
1258624|NCT00050089|E2|Reported Event|No ARDFP + Mega ART|Intensive Antiretroviral Treatment regimen
1258625|NCT00050089|E1|Reported Event|No ARDFP + Standard ART|Standard Antiretroviral Treatment regimen
1258626|NCT00050011|B3|Baseline|Total|Total of all reporting groups
1258657|NCT00049842|O1|Outcome|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
1258658|NCT00049842|O2|Outcome|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
1258760|NCT00049127|O4|Outcome|Study 3 Arm D|Phase II patients on EIACs and >2 prior regimens
1258627|NCT00050011|B2|Baseline|Zoledronic Acid Delayed-start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid upfront 4 mg IV 15-minute infusion every 6 months."
1258628|NCT00050011|B1|Baseline|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid upfront 4 mg IV 15-minute infusion every 6 months."
1258629|NCT00050011|P2|Participant Flow|Zoledronic Acid Delayed-start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on zoledronic acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic acid 4 mg IV 15-minute infusion every 6 months."
1258630|NCT00050011|P1|Participant Flow|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence) or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
1258631|NCT00050011|O2|Outcome|Zoledronic Acid Delayed Start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
1258632|NCT00050011|O1|Outcome|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
1258633|NCT00050011|O2|Outcome|Zoledronic Acid Delayed Start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
1258634|NCT00050011|O1|Outcome|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
1258635|NCT00050011|O2|Outcome|Zoledronic Acid Delayed Start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
1258636|NCT00050011|O1|Outcome|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
1258637|NCT00050011|O2|Outcome|Zoledronic Acid Delayed Start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
1258638|NCT00050011|O1|Outcome|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
1258659|NCT00049842|O1|Outcome|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
1258639|NCT00050011|O2|Outcome|Zoledronic Acid Delayed Start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
1258640|NCT00050011|O1|Outcome|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
1258641|NCT00050011|O2|Outcome|Zoledronic Acid Delayed Start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
1258642|NCT00050011|O1|Outcome|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
1258643|NCT00050011|O2|Outcome|Zoledronic Acid Delayed Start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
1258644|NCT00050011|O1|Outcome|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
1258645|NCT00050011|O2|Outcome|Zoledronic Acid Delayed-start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on zoledronic acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
1258646|NCT00050011|O1|Outcome|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
1258647|NCT00050011|E2|Reported Event|Zoledronic Acid Delayed-start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on zoledronic acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily. Zoledronic Acid : Participants received Zoledronic acid 4 mg IV 15-minute infusion every 6 months."
1258648|NCT00050011|E1|Reported Event|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Femara 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily. Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
1258649|NCT00049842|B3|Baseline|Total|Total of all reporting groups
1258650|NCT00049842|B2|Baseline|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
1258651|NCT00049842|B1|Baseline|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
1258652|NCT00049842|P2|Participant Flow|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
1258653|NCT00049842|P1|Participant Flow|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
1258654|NCT00049842|O2|Outcome|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
1258655|NCT00049842|O1|Outcome|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
1258656|NCT00049842|O2|Outcome|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
1258660|NCT00049842|O2|Outcome|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
1258661|NCT00049842|O1|Outcome|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
1258662|NCT00049842|O2|Outcome|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
1258663|NCT00049842|O1|Outcome|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
1258664|NCT00049842|O2|Outcome|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
1258665|NCT00049842|O1|Outcome|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
1258666|NCT00049842|E2|Reported Event|Untreated Control|
1258667|NCT00049842|E1|Reported Event|PEG-Intron|
1258668|NCT00049543|B3|Baseline|Total|Total of all reporting groups
1258669|NCT00049543|B2|Baseline|Arm II (Placebo)|"Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
1258670|NCT00049543|B1|Baseline|Arm I (Gefitinib)|"Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~gefitinib: Given PO~laboratory biomarker analysis: Correlative studies"
1258671|NCT00049543|P2|Participant Flow|Arm II (Placebo)|"Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
1258672|NCT00049543|P1|Participant Flow|Arm I (Gefitinib)|"Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~gefitinib: Given PO~laboratory biomarker analysis: Correlative studies"
1258673|NCT00049543|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
1258674|NCT00049543|O1|Outcome|Arm I (Gefitinib)|"Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~gefitinib: Given PO~laboratory biomarker analysis: Correlative studies"
1258675|NCT00049543|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
1258676|NCT00049543|O1|Outcome|Arm I (Gefitinib)|"Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~gefitinib: Given PO~laboratory biomarker analysis: Correlative studies"
1258677|NCT00049543|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
1258678|NCT00049543|O1|Outcome|Arm I (Gefitinib)|"Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~gefitinib: Given PO~laboratory biomarker analysis: Correlative studies"
1258679|NCT00049543|E2|Reported Event|Arm II (Placebo)|"Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
1258680|NCT00049543|E1|Reported Event|Arm I (Gefitinib)|"Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~gefitinib: Given PO~laboratory biomarker analysis: Correlative studies"
1258681|NCT00049530|B1|Baseline|PEG-Interferon Alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
1258682|NCT00049530|P1|Participant Flow|PEG-interferon Alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
1258683|NCT00049530|O1|Outcome|PEG-interferon Alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
1258684|NCT00049530|O1|Outcome|PEG-interferon Alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
1258685|NCT00049530|O1|Outcome|PEG-interferon Alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
1258686|NCT00049530|O1|Outcome|PEG-interferon Alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
1258687|NCT00049530|E1|Reported Event|PEG-Interferon Alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
1258688|NCT00049517|B3|Baseline|Total|Total of all reporting groups
1258689|NCT00049517|B2|Baseline|High Dose Daunorubicin (Induction Therapy)|Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine as in arm I. Patients may receive a second course of induction therapy if CR is not achieved after the first course. The second course is administered as in arm I.
1258690|NCT00049517|B1|Baseline|Standard Daunorubicin (Induction Therapy)|"Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7.~Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course."
1258691|NCT00049517|P6|Participant Flow|High-dose Daunorubicin Then Allogeneic HCT or no Consolidation|"Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.~Consolidation/Transplant:~Patients without CR did not receive any consolidation treatment. Patients in CR with an unfavorable cytogenetic profile or an initial white blood cell count > 100,000/μL were to proceed to allogeneic HCT if they had a suitable human leukocyte antigen (HLA)-matched sibling donor available."
1258692|NCT00049517|P5|Participant Flow|Standard Daunorubicin Then Allogeneic HCT or no Consolidation|"Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.~Consolidation/Transplant:~Patients without CR did not receive any consolidation treatment. Patients in CR with an unfavorable cytogenetic profile or an initial white blood cell count > 100,000/μL were to proceed to allogeneic HCT if they had a suitable human leukocyte antigen (HLA)-matched sibling donor available."
1258693|NCT00049517|P4|Participant Flow|High-dose Daunorubicin Then GO/Autologous HCT|"Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.~Consolidation/Transplant:~Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts. patients randomized to the investigational arm received a single dose of Gemtuzumab ozogamicin (GO) at 6 mg/m2 followed by sargramostim 250 μ/m2 until recovery of counts.~The patients undergoing autologous HCT received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days."
1258694|NCT00049517|P3|Participant Flow|Standard Daunorubicin Then GO/Autologous HCT|"Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.~Consolidation/Transplant:~Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts. patients randomized to the investigational arm received a single dose of Gemtuzumab ozogamicin (GO) at 6 mg/m2 followed by sargramostim 250 μ/m2 until recovery of counts.~The patients undergoing autologous HCT received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days."
1258695|NCT00049517|P2|Participant Flow|High-dose Daunorubicin Then Autologous HCT|"Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.~Consolidation/Transplant:~Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts.~The patients undergoing autologous hematopoietic cell transplantation (HCT) received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses (without pharmacokinetic sampling) followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days."
1258696|NCT00049517|P1|Participant Flow|Standard Daunorubicin Then Autologous HCT|"Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.~Consolidation/Transplant:~Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts.~The patients undergoing autologous hematopoietic cell transplantation (HCT) received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses (without pharmacokinetic sampling) followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days."
1258697|NCT00049517|O2|Outcome|Go/Autologous HCT|Patients with CR in the induction phase were randomized to receive autologous HCT or GO/autologous HCT.
1258698|NCT00049517|O1|Outcome|Autologous HCT|Patients with CR in the induction phase were randomized to receive autologous HCT or GO/autologous HCT.
1258699|NCT00049517|O2|Outcome|Go/Autologous HCT|Patients with CR in the induction phase were randomized to receive autologous HCT or GO/autologous HCT.
1258700|NCT00049517|O1|Outcome|Autologous HCT|Patients with CR in the induction phase were randomized to receive autologous HCT or GO/autologous HCT.
1258701|NCT00049517|O2|Outcome|High-dose Daunorubicin|Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Patients with CR received consolidation treatment thereafter.
1258702|NCT00049517|O1|Outcome|Standard Daunorubicin|Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Patients with CR received consolidation treatment thereafter.
1258749|NCT00049127|O5|Outcome|Study 3 Arm E|Phase II patients not on EIACs and >2 prior regimens
1258750|NCT00049127|O4|Outcome|Study 3 Arm D|Phase II patients on EIACs and >2 prior regimens
1258703|NCT00049517|E2|Reported Event|High Dose Daunorubicin (Induction Therapy)|"Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine as in arm I. Patients may receive a second course of induction therapy if CR is not achieved after the first course. The second course is administered as in arm I.~Conditioning/Transplant:~Patients receive gemtuzumab ozogamicin IV over 2 hours on day 1 and GM-CSF SC or IV beginning on day 10 and continuing until blood counts recover. Within 2-3 weeks after blood count recovery, patients receive conditioning and undergo autologous PBSC transplantation as in arm I."
1258704|NCT00049517|E1|Reported Event|Standard Daunorubicin (Induction Therapy)|"Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.~Conditioning/Transplant:~Patients receive conditioning comprising busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then undergo autologous peripheral blood stem cell (PBSC) transplantation on day 0. Patients receive sargramostim (GM-CSF) or filgrastim (G-CSF) IV or subcutaneously (SC) beginning on day 0 and continuing until blood counts recover."
1258705|NCT00049504|B1|Baseline|Treatment (Nonmyeloablative HSCT)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total body irradiation on day -1.~TRANSPLANTATION: Patients undergo BMT, from an HLA-haploidentical donor, on day 0.~POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3.~GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV over 1-2 hours and then tacrolimus PO, once tolerated, on days 4-180, with taper on day 86 in the absence of graft-versus-host disease. Patients also receive mycophenolate mofetil PO three times daily on days 4-35."
1258706|NCT00049504|P1|Participant Flow|Treatment (Nonmyeloablative HSCT)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total body irradiation on day -1.~TRANSPLANTATION: Patients undergo BMT, from an HLA-haploidentical donor, on day 0.~POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3.~GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV over 1-2 hours and then tacrolimus PO, once tolerated, on days 4-180, with taper on day 86 in the absence of graft-versus-host disease. Patients also receive mycophenolate mofetil PO three times daily on days 4-35."
1258707|NCT00049504|O1|Outcome|Treatment (Nonmyeloablative HSCT)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total body irradiation on day -1.~TRANSPLANTATION: Patients undergo BMT, from an HLA-haploidentical donor, on day 0.~POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3.~GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV over 1-2 hours and then tacrolimus PO, once tolerated, on days 4-180, with taper on day 86 in the absence of graft-versus-host disease. Patients also receive mycophenolate mofetil PO three times daily on days 4-35."
1258708|NCT00049504|O1|Outcome|Treatment (Nonmyeloablative HSCT)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total body irradiation on day -1.~TRANSPLANTATION: Patients undergo BMT, from an HLA-haploidentical donor, on day 0.~POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3.~GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV over 1-2 hours and then tacrolimus PO, once tolerated, on days 4-180, with taper on day 86 in the absence of graft-versus-host disease. Patients also receive mycophenolate mofetil PO three times daily on days 4-35."
1258709|NCT00049504|O1|Outcome|Treatment (Nonmyeloablative HSCT)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total body irradiation on day -1.~TRANSPLANTATION: Patients undergo BMT, from an HLA-haploidentical donor, on day 0.~POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3.~GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV over 1-2 hours and then tacrolimus PO, once tolerated, on days 4-180, with taper on day 86 in the absence of graft-versus-host disease. Patients also receive mycophenolate mofetil PO three times daily on days 4-35."
1258710|NCT00049504|E1|Reported Event|Treatment (Nonmyeloablative HSCT)|"NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total body irradiation on day -1.~TRANSPLANTATION: Patients undergo BMT, from an HLA-haploidentical donor, on day 0.~POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3.~GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV over 1-2 hours and then tacrolimus PO, once tolerated, on days 4-180, with taper on day 86 in the absence of graft-versus-host disease. Patients also receive mycophenolate mofetil PO three times daily on days 4-35."
1258711|NCT00049322|B3|Baseline|Total|Total of all reporting groups
1258712|NCT00049322|B2|Baseline|Arm II (TACE-O Arm )|Observation
1258713|NCT00049322|B1|Baseline|Arm I (TACE-BEV Arm)|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.~Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
1258714|NCT00049322|P2|Participant Flow|Arm II (TACE-O Arm )|Observation
1258715|NCT00049322|P1|Participant Flow|Arm I (TACE-BEV Arm)|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.~Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
1258716|NCT00049322|O1|Outcome|Arm I (TACE-BEV Arm)|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.~Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
1258717|NCT00049322|O1|Outcome|Arm I (TACE-BEV Arm)|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.~Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
1258718|NCT00049322|O2|Outcome|Arm II-chemoembolization|chemoembolization as part of standard of care
1258719|NCT00049322|O1|Outcome|Arm I-bevacizumab|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.~Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
1258720|NCT00049322|O2|Outcome|Arm II (TACE-O Arm )|Observation
1258721|NCT00049322|O1|Outcome|Arm I (TACE-BEV Arm)|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.~Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
1258722|NCT00049322|O2|Outcome|Arm II (TACE-O Arm )|Observation
1258723|NCT00049322|O1|Outcome|Arm I (TACE-BEV Arm)|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.~Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
1258724|NCT00049322|E2|Reported Event|Arm II|Patients do not receive bevacizumab
1258725|NCT00049322|E1|Reported Event|Arm I|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.~Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
1258726|NCT00049257|B1|Baseline|Carboplatin, Paclitaxel|"Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter."
1258727|NCT00049257|P1|Participant Flow|Carboplatin, Paclitaxel|"Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter."
1258728|NCT00049257|O1|Outcome|Carboplatin, Paclitaxel|"Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter."
1258729|NCT00049257|O1|Outcome|Carboplatin, Paclitaxel|"Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter."
1258730|NCT00049257|O1|Outcome|Carboplatin, Paclitaxel|"Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter."
1258731|NCT00049257|O1|Outcome|Carboplatin, Paclitaxel|"Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter."
1258732|NCT00049257|E1|Reported Event|Carboplatin, Paclitaxel|"Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter."
1258733|NCT00049127|B6|Baseline|Total|Total of all reporting groups
1258734|NCT00049127|B5|Baseline|Study 3 Arm E|Phase II patients not on EIACs and >2 prior regimens
1258735|NCT00049127|B4|Baseline|Study 3 Arm D|Phase II patients on EIACs and >2 prior regimens
1258736|NCT00049127|B3|Baseline|Study 2 Arm B|Phase II patients not on EIACs and <=2 prior regimens
1258737|NCT00049127|B2|Baseline|Study 2 Arm A|Phase II patients on EIACs and <=2 prior regimens
1258738|NCT00049127|B1|Baseline|Study 1 Arm C|Phase I patients on EIACs and <=2 prior regimens
1258739|NCT00049127|P5|Participant Flow|Study 3 Arm E|"Phase II patients not on enzyme-inducing anticonvulsants (EIACs) and >2 prior regimens~Imatinib at 300 mg b.i.d."
1258740|NCT00049127|P4|Participant Flow|Study 3 Arm D|"Phase II patients on enzyme-inducing anticonvulsants (EIACs) and >2 prior regimens~Imatinib at Maximum Tolerated Dose (MTD) from Study 1 mg p.o. bid daily"
1258741|NCT00049127|P3|Participant Flow|Study 2 Arm B|"Phase II patients not on enzyme-inducing anticonvulsants (EIACs) and <=2 prior regimens~Imatinib at 300 mg b.i.d."
1258742|NCT00049127|P2|Participant Flow|Study 2 Arm A|"Phase II patients on enzyme-inducing anticonvulsants (EIACs) and <=2 prior regimens~Imatinib at Maximum Tolerated Dose (MTD) from Study 1 mg p.o. bid daily"
1258743|NCT00049127|P1|Participant Flow|Study 1 Arm C|"Phase I patients on enzyme-inducing anticonvulsants (EIACs) and <=2 prior regimens~Imatinib at assigned dose. Escalation of cohorts-of-3 per section 7.1 of the protocol. Assigned dose will be administered p.o. twice daily in divided doses."
1258744|NCT00049127|O5|Outcome|Study 3 Arm E|Phase II patients not on EIACs and >2 prior regimens
1258745|NCT00049127|O4|Outcome|Study 3 Arm D|Phase II patients on EIACs and >2 prior regimens
1258746|NCT00049127|O3|Outcome|Study 2 Arm B|Phase II patients not on EIACs and <=2 prior regimens
1258747|NCT00049127|O2|Outcome|Study 2 Arm A|Phase II patients on EIACs and <=2 prior regimens
1258748|NCT00049127|O1|Outcome|Study 1 Arm C|Phase I patients on EIACs and <=2 prior regimens
1258763|NCT00049127|O1|Outcome|Study 1 Arm C|Phase I patients on EIACs and <=2 prior regimens
1258764|NCT00049127|E5|Reported Event|Study 3 Arm E|Phase II patients not on EIACs and >2 prior regimens
1258765|NCT00049127|E4|Reported Event|Study 3 Arm D|Phase II patients on EIACs and >2 prior regimens
1258766|NCT00049127|E3|Reported Event|Study 1 Arm C|Phase I patients on EIACs and <=2 prior regimens
1258767|NCT00049127|E2|Reported Event|Study 2 Arm B|Phase II patients not on EIACs and <=2 prior regimens
1258768|NCT00049127|E1|Reported Event|Study 2 Arm A|Phase II patients on EIACs and <=2 prior regimens
1258769|NCT00049036|B3|Baseline|Total|Total of all reporting groups
1258770|NCT00049036|B2|Baseline|EPOCH Followed by Rituximab|Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.
1258771|NCT00049036|B1|Baseline|EPOCH + Concurrent Rituximab|Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.
1258772|NCT00049036|P2|Participant Flow|EPOCH Followed by Rituximab|Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.
1258773|NCT00049036|P1|Participant Flow|EPOCH + Concurrent Rituximab|Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.
1258774|NCT00049036|O2|Outcome|EPOCH Followed by Rituximab|Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.
1258775|NCT00049036|O1|Outcome|EPOCH + Concurrent Rituximab|Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.
1258776|NCT00049036|E2|Reported Event|EPOCH Followed by Rituximab|Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.
1258777|NCT00049036|E1|Reported Event|EPOCH + Concurrent Rituximab|Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.
1258778|NCT00048997|B3|Baseline|Total|Total of all reporting groups
1258779|NCT00048997|B2|Baseline|Observation|Observation.
1258780|NCT00048997|B1|Baseline|Prophylactic Cranial Irradiation (PCI)|PCI is given to the whole brain in a dose of 2 Gy per fraction, 5 days per week, for 3 weeks for a total dose of 30 Gy.
1258781|NCT00048997|P2|Participant Flow|Observation|Observation
1258782|NCT00048997|P1|Participant Flow|Prophylactic Cranial Irradiation (PCI)|PCI is given to the whole brain in a dose of 2 Gy per fraction, 5 days per week, for 3 weeks for a total dose of 30 Gy.
1258783|NCT00048997|O2|Outcome|Observation|Observation
1258784|NCT00048997|O1|Outcome|Prophylactic Cranial Irradiation (PCI)|PCI is given to the whole brain in a dose of 2 Gy per fraction, 5 days per week, for 3 weeks for a total dose of 30 Gy.
1258785|NCT00048997|E1|Reported Event|Prophylactic Cranial Irradiation (PCI)|PCI is given to the whole brain in a dose of 2 Gy per fraction, 5 days per week, for 3 weeks for a total dose of 30 Gy..
1258786|NCT00048932|B3|Baseline|Total|Total of all reporting groups
1258787|NCT00048932|B2|Baseline|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
1258788|NCT00048932|B1|Baseline|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
1258789|NCT00048932|P3|Participant Flow|Open Label (OL) Abatacept|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
1258790|NCT00048932|P2|Participant Flow|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
1258791|NCT00048932|P1|Participant Flow|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
1258792|NCT00048932|O1|Outcome|All Treated Participants|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
1258793|NCT00048932|O1|Outcome|OL ABA|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
1258794|NCT00048932|O1|Outcome|OL ABA|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
1258795|NCT00048932|O1|Outcome|OL ABA|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
1258796|NCT00048932|O1|Outcome|OL ABA|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
1258797|NCT00048932|O1|Outcome|OL ABA|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
1258798|NCT00048932|O1|Outcome|OL ABA|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
1258799|NCT00048932|O1|Outcome|OL ABA|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
1258800|NCT00048932|O2|Outcome|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
1258801|NCT00048932|O1|Outcome|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
1258802|NCT00048932|O1|Outcome|All Treated Participants|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
1258803|NCT00048932|O2|Outcome|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
1258804|NCT00048932|O1|Outcome|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
1258805|NCT00048932|O2|Outcome|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
1258806|NCT00048932|O1|Outcome|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
1258807|NCT00048932|O2|Outcome|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
1258808|NCT00048932|O1|Outcome|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
1258809|NCT00048932|O2|Outcome|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
1258810|NCT00048932|O1|Outcome|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
1258811|NCT00048932|E3|Reported Event|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
1258812|NCT00048932|E2|Reported Event|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for subjects < 60 kg, 750 mg for subjects 60 to 100 kg and 1 g for subjects > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
1258813|NCT00048932|E1|Reported Event|Open Label (OL) Abatacept|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
1258814|NCT00048893|B1|Baseline|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
1258815|NCT00048893|P1|Participant Flow|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
1258816|NCT00048893|O1|Outcome|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
1258817|NCT00048893|O1|Outcome|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
1258818|NCT00048893|O1|Outcome|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
1258819|NCT00048893|O1|Outcome|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
1258820|NCT00048893|O1|Outcome|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
1258821|NCT00048893|O1|Outcome|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
1258822|NCT00048893|O1|Outcome|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
1258823|NCT00048893|O1|Outcome|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
1258824|NCT00048893|E1|Reported Event|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
1258825|NCT00048737|B1|Baseline|90Y Zevalin in ASCT|"Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen.~Rituximab : 250 mg/m^2 on day 1 and day 8~Allogeneic Stem Cell Transplantation : Allogeneic stem cell transplantation 2 days after chemotherapy~Cyclophosphamide : 750 mg/m^2/day x 3, given on the same days as fludarabine, at 4-hour intervals~Zevalin Radioimmunotherapy : Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg~Fludarabine : 30 mg/m^2/day x 3"
1258826|NCT00048737|P1|Participant Flow|90Y Zevalin in ASCT|"Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen.~Rituximab : 250 mg/m^2 on day 1 and day 8~Allogeneic Stem Cell Transplantation : Allogeneic stem cell transplantation 2 days after chemotherapy~Cyclophosphamide : 750 mg/m^2/day x 3, given on the same days as fludarabine, at 4-hour intervals~Zevalin Radioimmunotherapy : Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg~Fludarabine : 30 mg/m^2/day x 3"
1258827|NCT00048737|O1|Outcome|90Y Zevalin in ASCT|"Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen.~Rituximab: 250 mg/m^2 on day 1 and day 8~Allogeneic Stem Cell Transplantation : Allogeneic stem cell transplantation 2 days after chemotherapy~Cyclophosphamide : 750 mg/m^2/day x 3, given on the same days as fludarabine, at 4-hour intervals~Zevalin Radioimmunotherapy : Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg~Fludarabine : 30 mg/m^2/day x 3"
1258828|NCT00048737|E1|Reported Event|90Y Zevalin in ASCT|"Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen.~Rituximab : 250 mg/m^2 on day 1 and day 8~Allogeneic Stem Cell Transplantation : Allogeneic stem cell transplantation 2 days after chemotherapy~Cyclophosphamide : 750 mg/m^2/day x 3, given on the same days as fludarabine, at 4-hour intervals~Zevalin Radioimmunotherapy : Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg~Fludarabine : 30 mg/m^2/day x 3"
1258829|NCT00048724|B3|Baseline|Total|Total of all reporting groups
1258830|NCT00048724|B2|Baseline|Untreated Control|
1258831|NCT00048724|B1|Baseline|PegIntron|PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
1258832|NCT00048724|P2|Participant Flow|Untreated Control|
1258833|NCT00048724|P1|Participant Flow|PegIntron|PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
1258834|NCT00048724|O2|Outcome|Untreated Control|
1258835|NCT00048724|O1|Outcome|PegIntron|PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
1258836|NCT00048724|O2|Outcome|Untreated Control|
1258837|NCT00048724|O1|Outcome|PegIntron|PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
1258838|NCT00048724|E2|Reported Event|Untreated Control|
1258839|NCT00048724|E1|Reported Event|PegIntron|
1258840|NCT00048581|B3|Baseline|Total|Total of all reporting groups
1258841|NCT00048581|B2|Baseline|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258842|NCT00048581|B1|Baseline|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258843|NCT00048581|P3|Participant Flow|Open-label ABA|All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period, based on their entry weight into the study. Participant dose was adjusted based on annual anniversary weight. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
1258844|NCT00048581|P2|Participant Flow|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258867|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1259741|NCT00046891|O1|Outcome|Ginko Bibola|Median change from baseline to different time points.
1259621|NCT00047619|O2|Outcome|Sham Lavage Group|"sham pulsatile lavage~sham pulsatile lavage: pulsatile lavage to not directed at wound or patient"
1258845|NCT00048581|P1|Participant Flow|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258846|NCT00048581|O1|Outcome|All Treated Participants|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive either abatacept or placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of abatacept. Abatacept or placebo was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258847|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258848|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258849|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258850|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258851|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258852|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258853|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258854|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258855|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258856|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258857|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258858|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258859|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258860|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258861|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258862|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258863|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258864|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258865|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258866|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1259616|NCT00047619|B1|Baseline|Pulsatile Lavage Group|"pulsatile lavage therapy~Pulsatile Lavage: pulsatile lavage to wound bed"
1258868|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258869|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258870|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258871|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258872|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258873|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258874|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258875|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258876|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258877|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258878|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258879|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258880|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258881|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258882|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258883|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258884|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258885|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258886|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258887|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258888|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258889|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258890|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258891|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1259208|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1258892|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258893|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258894|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258895|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258896|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258897|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258898|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258899|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258900|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258901|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258902|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258903|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258904|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258905|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258906|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258907|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258908|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258909|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258910|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258911|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258912|NCT00048581|O1|Outcome|OL: ABA|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258913|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258914|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258915|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258916|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258917|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258918|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258919|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258920|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258921|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258922|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258923|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258924|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258925|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258926|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258927|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258928|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258929|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258930|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258931|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258932|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258933|NCT00048581|O1|Outcome|Open-label ABA|All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period, based on their entry weight into the study. Participant dose was adjusted based on annual anniversary weight. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
1258934|NCT00048581|O1|Outcome|Open-label ABA|All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period, based on their entry weight into the study. Participant dose was adjusted based on annual anniversary weight. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
1258935|NCT00048581|O1|Outcome|Open-label ABA|All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period, based on their entry weight into the study. Participant dose was adjusted based on annual anniversary weight. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
1259434|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
1258936|NCT00048581|O1|Outcome|All Treated DB Participants|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive either abatacept or placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of abatacept. Abatacept or placebo was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258937|NCT00048581|O1|Outcome|Open-label ABA|All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period, based on their entry weight into the study. Participant dose was adjusted based on annual anniversary weight. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
1258938|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258939|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258940|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258941|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258942|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258943|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258944|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258945|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258946|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258947|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258948|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1259020|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1258949|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258950|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258951|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258952|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258953|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258954|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258955|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258956|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258957|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258958|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258959|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258960|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258961|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258962|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258963|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258964|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258965|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258966|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258967|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258968|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258969|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258970|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258971|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258972|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258973|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258974|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258975|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258976|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258977|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258978|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258979|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258980|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258981|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258982|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258983|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258984|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258985|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258986|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258987|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258988|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258989|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258990|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258991|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258992|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258993|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258994|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258995|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258996|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258997|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1258998|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1258999|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1259000|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1259001|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1259002|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1259003|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1259004|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1259005|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1259006|NCT00048581|E3|Reported Event|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
1259007|NCT00048581|E2|Reported Event|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
1259008|NCT00048581|E1|Reported Event|Open-label ABA|All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
1259009|NCT00048568|B3|Baseline|Total|Total of all reporting groups
1259010|NCT00048568|B2|Baseline|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259011|NCT00048568|B1|Baseline|ABA + MTX DB|Abatacept was dosed by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259012|NCT00048568|P3|Participant Flow|ABA + MTX [Open-label (OL)]|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259013|NCT00048568|P2|Participant Flow|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259014|NCT00048568|P1|Participant Flow|Abatacept (ABA) + Methotrexate (MTX) DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity.
1259015|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259016|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259017|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259018|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259019|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259321|NCT00048542|O1|Outcome|OLE BSA Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
1259021|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259022|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259023|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259024|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259025|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259026|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259027|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259028|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259029|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259030|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259031|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259032|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259033|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259034|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259035|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259036|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259085|NCT00048568|O2|Outcome|Placebo + MTX DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259037|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259038|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259039|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259040|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259041|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259042|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259043|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259044|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259045|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259046|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259047|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259048|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259049|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259050|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259051|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259052|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259104|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259053|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259054|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259055|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259056|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259057|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259058|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259059|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259060|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259061|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259062|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259063|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259064|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259065|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259066|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259067|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259068|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259105|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259069|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259070|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259071|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259072|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259073|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259074|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259075|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259076|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259077|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259078|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259079|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259080|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259081|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259082|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259083|NCT00048568|O2|Outcome|Placebo + MTX DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259084|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259353|NCT00048542|O3|Outcome|Adalimumab + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX double-blind phase.
1259742|NCT00046891|O2|Outcome|Placebo|Placebo: Patients will take 1 tablet BID
1259086|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259087|NCT00048568|O2|Outcome|Placebo + MTX DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259088|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259089|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259090|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259091|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259092|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259093|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259094|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259095|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259096|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259097|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259098|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259099|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259100|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259101|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259102|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259103|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259106|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259107|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259108|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259109|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259110|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259111|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259112|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259113|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259114|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259115|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259116|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259117|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259118|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259119|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259120|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259121|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259122|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
1259354|NCT00048542|O2|Outcome|Placebo|Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.
1259123|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259124|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
1259125|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259126|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
1259127|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259128|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
1259129|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259130|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
1259131|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259132|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
1259133|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259134|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
1259135|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259136|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
1259137|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259138|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
1259157|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259139|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259140|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
1259141|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259142|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
1259143|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259144|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
1259145|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259146|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
1259147|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259148|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
1259149|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259150|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
1259151|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259152|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259153|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259154|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259155|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259156|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259158|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259159|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259160|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259161|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259162|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259163|NCT00048568|O1|Outcome|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259164|NCT00048568|O1|Outcome|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259165|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259166|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
1259167|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259168|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
1259169|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259170|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
1259171|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259172|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
1259173|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259174|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
1259191|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259743|NCT00046891|O1|Outcome|Ginkgo Biloba|Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
1259175|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259176|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259177|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259178|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259179|NCT00048568|O1|Outcome|ABA + MTX Cumulative DB + OL Periods|Abatacept was dosed intravenously by weight at 10 mg/kg in the DB and OL periods under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259180|NCT00048568|O2|Outcome|Placebo + MTX DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259181|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259182|NCT00048568|O2|Outcome|Placebo + MTX DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259183|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259184|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259185|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259186|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259187|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259188|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259189|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259190|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259355|NCT00048542|O1|Outcome|Adalimumab|Subjects received adalimumab during open-label lead-in phase and during the double-blind phase.
1259192|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259193|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259194|NCT00048568|O2|Outcome|MTX + Placebo|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259195|NCT00048568|O1|Outcome|ABA + MTX|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259196|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259197|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259198|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259199|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259200|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259201|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259202|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259203|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259204|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259205|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259206|NCT00048568|O2|Outcome|Placebo + MTX DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259207|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259356|NCT00048542|O4|Outcome|Placebo + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
1259744|NCT00046891|O2|Outcome|Placebo|Placebo: Patients will take 1 tablet BID
1259209|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259210|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259211|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259212|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259213|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259214|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the DB period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
1259215|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259216|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259217|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259218|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259219|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259220|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259221|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259222|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259223|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259240|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259224|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259225|NCT00048568|O1|Outcome|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259226|NCT00048568|O1|Outcome|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259227|NCT00048568|O1|Outcome|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259228|NCT00048568|O1|Outcome|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259229|NCT00048568|O1|Outcome|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259230|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259231|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259232|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259233|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259234|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259235|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259236|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259237|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259238|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259239|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259357|NCT00048542|O3|Outcome|Adalimumab + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.
1259241|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259242|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259243|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259244|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259245|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259246|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259247|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259248|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259249|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259250|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259251|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259252|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259253|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259254|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259255|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259358|NCT00048542|O2|Outcome|Placebo|Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.
1259256|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259257|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259258|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259259|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259260|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259261|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259262|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259263|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259264|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259265|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259266|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259267|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259268|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259269|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259270|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259286|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259271|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259272|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259273|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259274|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259275|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259276|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259277|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259278|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259279|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259280|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259281|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259282|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259283|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259284|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259285|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259359|NCT00048542|O1|Outcome|Adalimumab|Subjects received adalimumab during the open-label lead-in phase and during the double-blind phase.
1259287|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259288|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259289|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed by weight with participants weighing < 60 kg received 500 mg, subjects weighing 60 kg to 100 kg received 750 mg, and subjects weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity.
1259290|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259291|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed by weight with participants weighing < 60 kg received 500 mg, subjects weighing 60 kg to 100 kg received 750 mg, and subjects weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity.
1259292|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259293|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259294|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259295|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259296|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259297|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259298|NCT00048568|E3|Reported Event|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
1259299|NCT00048568|E2|Reported Event|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
1259300|NCT00048568|E1|Reported Event|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
1259301|NCT00048542|B5|Baseline|Total|Total of all reporting groups
1259302|NCT00048542|B4|Baseline|Double-Blind Placebo|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose, administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
1259320|NCT00048542|O2|Outcome|OLE BSA Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
1259620|NCT00047619|O1|Outcome|Pulsatile Lavage Group|"pulsatile lavage therapy~Pulsatile Lavage: pulsatile lavage to wound bed"
1259303|NCT00048542|B3|Baseline|Double-Blind Adalimumab|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
1259304|NCT00048542|B2|Baseline|Double-Blind Placebo + MTX|"Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study.~MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening."
1259305|NCT00048542|B1|Baseline|Double-Blind Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
1259306|NCT00048542|P8|Participant Flow|Open-Label Extension FD Adalimumab|Subjects in the non-methotrexate (MTX) stratum received adalimumab without concomitant MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study in which body weight (not BSA) determined dosing. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
1259307|NCT00048542|P7|Participant Flow|Open-Label Extension FD Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum received adalimumab concomitantly with MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study in which only body weight (not BSA) determined dosing. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
1259308|NCT00048542|P6|Participant Flow|Open-Label Extension BSA Adalimumab|Subjects in the non-methotrexate (MTX) stratum received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose SC eow) without concomitant MTX treatment during the Open-Label Extension BSA Phase.
1259309|NCT00048542|P5|Participant Flow|Open-Label Extension BSA Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum received subcutaneous injections of 24 mg adalimumab per square meter of body surface area (BSA) up to a maximum of 40 mg total body dose every other week (eow) concomitantly with MTX treatment during the Open-Label Extension BSA Phase of the study.
1259310|NCT00048542|P4|Participant Flow|Double-Blind Placebo|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose, administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
1259311|NCT00048542|P3|Participant Flow|Double-Blind Adalimumab|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
1259312|NCT00048542|P2|Participant Flow|Double-Blind Placebo + MTX|"Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study.~MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening."
1259313|NCT00048542|P1|Participant Flow|Double-Blind Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
1259314|NCT00048542|O2|Outcome|OLE FD Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
1259315|NCT00048542|O1|Outcome|OLE FD Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
1259316|NCT00048542|O2|Outcome|OLE FD Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
1259317|NCT00048542|O1|Outcome|OLE FD Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
1259318|NCT00048542|O2|Outcome|OLE BSA Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
1259319|NCT00048542|O1|Outcome|OLE BSA Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
1259469|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
1259322|NCT00048542|O2|Outcome|OLE FD Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
1259323|NCT00048542|O1|Outcome|OLE FD Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension fixed dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
1259324|NCT00048542|O2|Outcome|OLE FD Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
1259325|NCT00048542|O1|Outcome|OLE FD Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension fixed dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
1259326|NCT00048542|O2|Outcome|OLE FD Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
1259327|NCT00048542|O1|Outcome|OLE FD Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension fixed dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
1259328|NCT00048542|O2|Outcome|OLE FD Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
1259329|NCT00048542|O1|Outcome|OLE FD Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension fixed dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
1259330|NCT00048542|O2|Outcome|OLE BSA Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
1259331|NCT00048542|O1|Outcome|OLE BSA Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
1259332|NCT00048542|O2|Outcome|OLE BSA Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
1259333|NCT00048542|O1|Outcome|OLE BSA Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
1259334|NCT00048542|O2|Outcome|OLE BSA Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
1259335|NCT00048542|O1|Outcome|OLE BSA Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
1259336|NCT00048542|O4|Outcome|Placebo + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
1259337|NCT00048542|O3|Outcome|Adalimumab + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.
1259338|NCT00048542|O2|Outcome|Placebo|Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.
1259339|NCT00048542|O1|Outcome|Adalimumab|Subjects received adalimumab during the open-label lead-in phase and during the double-blind phase.
1259340|NCT00048542|O4|Outcome|Placebo + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
1259341|NCT00048542|O3|Outcome|Adalimumab + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.
1259342|NCT00048542|O2|Outcome|Placebo|Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.
1259343|NCT00048542|O1|Outcome|Adalimumab|Subjects received adalimumab during the open-label lead-in phase and during the double-blind phase.
1259344|NCT00048542|O4|Outcome|Placebo + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
1259345|NCT00048542|O3|Outcome|Adalimumab + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.
1259346|NCT00048542|O2|Outcome|Placebo|Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.
1259347|NCT00048542|O1|Outcome|Adalimumab|Subjects received adalimumab during the open-label lead-in phase and during the double-blind phase.
1259348|NCT00048542|O4|Outcome|Placebo + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
1259349|NCT00048542|O3|Outcome|Adalimumab + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX double-blind phase.
1259350|NCT00048542|O2|Outcome|Placebo|Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.
1259351|NCT00048542|O1|Outcome|Adalimumab|Subjects received adalimumab during open-label lead-in phase and during the double-blind phase.
1259352|NCT00048542|O4|Outcome|Placebo + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
1259360|NCT00048542|O2|Outcome|Double-Blind Placebo + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg per square meter of body surface area [BSA] every other week [eow]) plus concomitant MTX treatment during the Double-Blind Phase. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
1259361|NCT00048542|O1|Outcome|Double-Blind Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg per square meter of body surface area [BSA] every other week [eow]) plus concomitant MTX treatment during the Double-Blind Phase. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
1259362|NCT00048542|O2|Outcome|Double-Blind Placebo|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
1259363|NCT00048542|O1|Outcome|Double-Blind Adalimumab|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
1259364|NCT00048542|O2|Outcome|Double-Blind Placebo + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo plus concomitant MTX during the Double-Blind Phase. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
1259365|NCT00048542|O1|Outcome|Double-Blind Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab plus concomitant MTX during the Double-Blind Phase. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
1259366|NCT00048542|O2|Outcome|Adalimumab|Subjects received open-label adalimumab (24 mg/square meter up to a maximum of 40 mg total body dose by body surface area [BSA] administered subcutaneously [SC] every other week [eow]), but no methotrexate (MTX), during the Open-Label Lead-In (OL-LI) Phase of the study.
1259367|NCT00048542|O1|Outcome|Adalimumab + MTX|Subjects received methotrexate (MTX) plus open-label adalimumab (24 mg/square meter up to a maximum of 40 mg total body dose by body surface area [BSA] administered subcutaneously [SC] every other week [eow]) during the Open-Label Lead-In (OL-LI) Phase of the study.
1259368|NCT00048542|O2|Outcome|Double-Blind Placebo|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
1259369|NCT00048542|O1|Outcome|Double-Blind Adalimumab|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
1259370|NCT00048542|E8|Reported Event|Open-Label Extension FD Adalimumab|Subjects in the methotrexate (MTX) stratum received adalimumab without concomitant MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study, in which subjects were dosed based on body weight (not BSA). Subjects were separated into 2 body weight categories; subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
1259371|NCT00048542|E7|Reported Event|Open-Label Extension FD Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum received adalimumab concomitantly with MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study, in which subjects were dosed based on body weight (not BSA). Subjects were separated into 2 body weight categories; subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
1259372|NCT00048542|E6|Reported Event|Open-Label Extension BSA Adalimumab|Subjects in the non-methotrexate (MTX) stratum received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose SC eow) without concomitant MTX treatment during the Open-Label Extension BSA Phase.
1259373|NCT00048542|E5|Reported Event|Open-Label Extension BSA Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum received subcutaneous injections of 24 mg adalimumab per square meter of body surface area (BSA) up to a maximum of 40 mg total body dose every other week (eow) concomitantly with MTX treatment during the Open-Label Extension BSA Phase of the study.
1259374|NCT00048542|E4|Reported Event|Double-Blind Placebo|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose, administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
1259375|NCT00048542|E3|Reported Event|Double-Blind Adalimumab|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
1259376|NCT00048542|E2|Reported Event|Double-Blind Placebo + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
1259736|NCT00046891|O2|Outcome|Think Clearly|Self-report cognition
1259377|NCT00048542|E1|Reported Event|Double-Blind Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
1259378|NCT00048347|B1|Baseline|Avonex|30 µg IM every week for 12 weeks
1259379|NCT00048347|P1|Participant Flow|Avonex|30 µg IM every week for 12 weeks
1259380|NCT00048347|O1|Outcome|Avonex|30 µg IM every week for 12 weeks
1259381|NCT00048347|E1|Reported Event|Avonex|30 µg IM every week for 12 weeks
1259382|NCT00048165|B3|Baseline|Total|Total of all reporting groups
1259383|NCT00048165|B2|Baseline|Placebo|Eligible participants were administered an intravenous matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259384|NCT00048165|B1|Baseline|Daclizumab|Eligible participants were administered an intravenous daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259385|NCT00048165|P2|Participant Flow|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259386|NCT00048165|P1|Participant Flow|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259387|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259388|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259389|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259390|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259391|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259392|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259393|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259394|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259432|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
1259737|NCT00046891|O1|Outcome|Stay Focused|Self-report cognition
1259395|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259396|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259397|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259398|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259399|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259400|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259401|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259402|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259403|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259404|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259405|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259406|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259407|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259408|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259433|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
1259738|NCT00046891|O2|Outcome|Placebo|Placebo: Patients will take 1 tablet BID
1259409|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259410|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259411|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259412|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259413|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259414|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259415|NCT00048165|E2|Reported Event|Placebo|Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259416|NCT00048165|E1|Reported Event|Daclizumab|Eligible participants were administered an intravenous daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
1259417|NCT00048074|B4|Baseline|Total|Total of all reporting groups
1259418|NCT00048074|B3|Baseline|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
1259419|NCT00048074|B2|Baseline|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
1259420|NCT00048074|B1|Baseline|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
1259421|NCT00048074|P3|Participant Flow|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
1259422|NCT00048074|P2|Participant Flow|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
1259423|NCT00048074|P1|Participant Flow|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
1259424|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
1259425|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
1259426|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
1259427|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
1259428|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
1259429|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
1259430|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
1259431|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
1259617|NCT00047619|P2|Participant Flow|Sham Lavage Group|"sham pulsatile lavage~sham pulsatile lavage: pulsatile lavage to not directed at wound or patient"
1259435|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
1259436|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
1259437|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
1259438|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
1259439|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
1259440|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
1259441|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
1259442|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
1259443|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
1259444|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
1259445|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
1259446|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
1259447|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
1259448|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
1259449|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
1259450|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
1259451|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
1259452|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
1259453|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
1259454|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
1259455|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
1259456|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
1259457|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
1259458|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
1259459|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
1259460|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
1259461|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
1259462|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
1259463|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
1259464|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
1259465|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
1259466|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
1259467|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
1259468|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
1259470|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
1259471|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
1259472|NCT00048074|E3|Reported Event|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
1259473|NCT00048074|E2|Reported Event|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
1259474|NCT00048074|E1|Reported Event|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
1259475|NCT00048061|B5|Baseline|Total|Total of all reporting groups
1259476|NCT00048061|B4|Baseline|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259477|NCT00048061|B3|Baseline|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259478|NCT00048061|B2|Baseline|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259479|NCT00048061|B1|Baseline|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259480|NCT00048061|P4|Participant Flow|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259481|NCT00048061|P3|Participant Flow|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259482|NCT00048061|P2|Participant Flow|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259483|NCT00048061|P1|Participant Flow|Ibandronate 2.5 mg|Participants received 2.5 milligram (mg) ibandronate Per oral (PO) daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 international units (IU) per day.
1259484|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259485|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259486|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259487|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259488|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259489|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259490|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259491|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259492|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259493|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259494|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259495|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259496|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259497|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259498|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259499|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259618|NCT00047619|P1|Participant Flow|Pulsatile Lavage Group|"pulsatile lavage therapy~Pulsatile Lavage: pulsatile lavage to wound bed"
1259500|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259501|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259502|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259503|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259504|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259505|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259506|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259507|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259508|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259509|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259510|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259511|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259512|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259513|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259514|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259515|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259516|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259517|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259518|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259519|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259520|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259521|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259522|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259523|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259524|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259525|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259526|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259527|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259528|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259619|NCT00047619|O2|Outcome|Sham Lavage Group|"sham pulsatile lavage~sham pulsatile lavage: pulsatile lavage to not directed at wound or patient"
1259529|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259530|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259531|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259532|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259533|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259534|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259535|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259536|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259537|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259538|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259539|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259540|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259541|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259542|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259543|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259544|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259545|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259546|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259547|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259548|NCT00048061|E4|Reported Event|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259549|NCT00048061|E3|Reported Event|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259550|NCT00048061|E2|Reported Event|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259551|NCT00048061|E1|Reported Event|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
1259552|NCT00048035|B7|Baseline|Total|Total of all reporting groups
1259553|NCT00048035|B6|Baseline|Cohort 6 (RO0503821 [0.6/150 1x/2 Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259554|NCT00048035|B5|Baseline|Cohort 5 (RO0503821 [0.6/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259555|NCT00048035|B4|Baseline|Cohort 4 (RO0503821 [0.4/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259612|NCT00047879|E2|Reported Event|Anaplastic Glioma Stratum|Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
1259556|NCT00048035|B3|Baseline|Cohort 3 (RO0503821 [0.4/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259557|NCT00048035|B2|Baseline|Cohort 2 (RO0503821 [0.25/150 1x/2 Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259558|NCT00048035|B1|Baseline|Cohort 1 (RO0503821 [0.25/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259559|NCT00048035|P8|Participant Flow|RO0503821 (1x/2Week)|Eligible participants were administered IV RO0503821 once every two weeks (1x/ 2week) using a dose conversion factor of 0.25/150, 0.40/150, and 0.60/150 mcg/kg of the previous weekly ESA dose in Cohort 2, Cohort 4, and Cohort 6, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259560|NCT00048035|P7|Participant Flow|RO0503821 (1x/Week)|Eligible participants were administered intravenously (IV) RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) once weekly (1x/ week) using a dose conversion factor of 0.25/150-, 0.40/150-, and 0.60/150 microgram (mcg)/kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose in Cohort 1, Cohort 3, and Cohort 5, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259561|NCT00048035|P6|Participant Flow|Cohort 6 (RO0503821 [0.6/150 1x/2 Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259562|NCT00048035|P5|Participant Flow|Cohort 5 (RO0503821 [0.6/150 1x/ Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259563|NCT00048035|P4|Participant Flow|Cohort 4 (RO0503821 [0.4/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259564|NCT00048035|P3|Participant Flow|Cohort 3 (RO0503821 [0.4/150 1x/ Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259565|NCT00048035|P2|Participant Flow|Cohort 2 (RO0503821 [0.25/150 1x/2 Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259566|NCT00048035|P1|Participant Flow|Cohort 1 (RO0503821 [0.25/150 1x/ Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259567|NCT00048035|O6|Outcome|Cohort 6 (RO0503821 [0.6/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259568|NCT00048035|O5|Outcome|Cohort 5 (RO0503821 [0.6/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259569|NCT00048035|O4|Outcome|Cohort 4 (RO0503821 [0.4/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259570|NCT00048035|O3|Outcome|Cohort 3 (RO0503821 [0.4/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259571|NCT00048035|O2|Outcome|Cohort 2 (RO0503821 [0.25/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259572|NCT00048035|O1|Outcome|Cohort 1 (RO0503821 [0.25/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259573|NCT00048035|O6|Outcome|Cohort 6 (RO0503821 [0.6/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259574|NCT00048035|O5|Outcome|Cohort 5 (RO0503821 [0.6/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259575|NCT00048035|O4|Outcome|Cohort 4 (RO0503821 [0.4/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259576|NCT00048035|O3|Outcome|Cohort 3 (RO0503821 [0.4/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259577|NCT00048035|O2|Outcome|Cohort 2 (RO0503821 [0.25/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259578|NCT00048035|O1|Outcome|Cohort 1 (RO0503821 [0.25/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259579|NCT00048035|O6|Outcome|Cohort 6 (RO0503821 [0.6/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259580|NCT00048035|O5|Outcome|Cohort 5 (RO0503821 [0.6/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259581|NCT00048035|O4|Outcome|Cohort 4 (RO0503821 [0.4/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259582|NCT00048035|O3|Outcome|Cohort 3 (RO0503821 [0.4/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259583|NCT00048035|O2|Outcome|Cohort 2 (RO0503821 [0.25/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259584|NCT00048035|O1|Outcome|Cohort 1 (RO0503821 [0.25/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259585|NCT00048035|O2|Outcome|RO0503821 (1x/2Week)|Eligible participants were administered IV RO0503821 once every two weeks (1x/ 2week) using a dose conversion factor of 0.25/150, 0.40/150, and 0.60/150 mcg/kg of the previous weekly ESA dose in Cohort 2, Cohort 4, and Cohort 6, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259586|NCT00048035|O1|Outcome|RO0503821 (1x/Week)|Eligible participants were administered IV RO0503821 once weekly (1x/ week) using a dose conversion factor of 0.25/150, 0.40/150, and 0.60/150 mcg/kg of the previous weekly ESA dose in Cohort 1, Cohort 3, and Cohort 5, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259587|NCT00048035|O6|Outcome|Cohort 6 (RO0503821 [0.6/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259588|NCT00048035|O5|Outcome|Cohort 5 (RO0503821 [0.6/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259589|NCT00048035|O4|Outcome|Cohort 4 (RO0503821 [0.4/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259613|NCT00047879|E1|Reported Event|Glioblastoma Multiforme Stratum|Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
1259590|NCT00048035|O3|Outcome|Cohort 3 (RO0503821 [0.4/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259591|NCT00048035|O2|Outcome|Cohort 2 (RO0503821 [0.25/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259592|NCT00048035|O1|Outcome|Cohort 1 (RO0503821 [0.25/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259593|NCT00048035|O6|Outcome|Cohort 6 (RO0503821 [0.6/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259594|NCT00048035|O5|Outcome|Cohort 5 (RO0503821 [0.6/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259595|NCT00048035|O4|Outcome|Cohort 4 (RO0503821 [0.4/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259596|NCT00048035|O3|Outcome|Cohort 3 (RO0503821 [0.4/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259597|NCT00048035|O2|Outcome|Cohort 2 (RO0503821 [0.25/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259598|NCT00048035|O1|Outcome|Cohort 1 (RO0503821 [0.25/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259599|NCT00048035|E2|Reported Event|RO0503821 (1/2week)|Eligible participants were administered IV RO0503821 once every two weeks (1x/ 2week) using a dose conversion factor of 0.25/150-, 0.40/150-, and 0.60/150 mcg/kg of the previous weekly ESA dose in Cohort 2, Cohort 4, and Cohort 6, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259600|NCT00048035|E1|Reported Event|RO0503821 (1/Week)|Eligible participants were administered IV RO0503821 once weekly (1x/ week) using a dose conversion factor of 0.25/150, 0.40/150, and 0.60/150 mcg/kg of the previous weekly ESA dose in Cohort 1, Cohort 3, and Cohort 5, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
1259601|NCT00047879|B3|Baseline|Total|Total of all reporting groups
1259602|NCT00047879|B2|Baseline|Anaplastic Glioma Stratum|Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
1259603|NCT00047879|B1|Baseline|Glioblastoma Multiforme Stratum|Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
1259604|NCT00047879|P2|Participant Flow|Anaplastic Glioma Stratum|Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
1259605|NCT00047879|P1|Participant Flow|Glioblastoma Multiforme Stratum|Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
1259606|NCT00047879|O2|Outcome|Anaplastic Glioma Stratum|Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
1259607|NCT00047879|O1|Outcome|Glioblastoma Multiforme Stratum|Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
1259608|NCT00047879|O2|Outcome|Anaplastic Glioma Stratum|Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
1259609|NCT00047879|O1|Outcome|Glioblastoma Multiforme Stratum|Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
1259610|NCT00047879|O2|Outcome|Anaplastic Glioma Stratum|Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
1259611|NCT00047879|O1|Outcome|Glioblastoma Multiforme Stratum|Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
1259614|NCT00047619|B3|Baseline|Total|Total of all reporting groups
1259615|NCT00047619|B2|Baseline|Sham Lavage Group|"sham pulsatile lavage~sham pulsatile lavage: pulsatile lavage not directed at wound or patient"
1259622|NCT00047619|O1|Outcome|Pulsatile Lavage Group|"pulsatile lavage therapy~Pulsatile Lavage: pulsatile lavage to wound bed"
1259623|NCT00047619|E2|Reported Event|Sham Lavage Group|"sham pulsatile lavage~sham pulsatile lavage: pulsatile lavage to not directed at wound or patient"
1259624|NCT00047619|E1|Reported Event|Pulsatile Lavage Group|"pulsatile lavage therapy~Pulsatile Lavage: pulsatile lavage to wound bed"
1259625|NCT00046228|B4|Baseline|Total|Total of all reporting groups
1259626|NCT00046228|B3|Baseline|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
1259627|NCT00046228|B2|Baseline|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
1259628|NCT00046228|B1|Baseline|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
1259629|NCT00046228|P3|Participant Flow|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
1259630|NCT00046228|P2|Participant Flow|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
1259631|NCT00046228|P1|Participant Flow|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
1259632|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
1259633|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
1259634|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
1259635|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
1259636|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
1259637|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
1259638|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
1259639|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
1259640|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
1259641|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
1259642|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
1259643|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
1259644|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
1259645|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
1259646|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
1259647|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
1259648|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
1259649|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
1259650|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
1259651|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
1259652|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
1259653|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
1259654|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
1259655|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
1259656|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
1259657|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
1259658|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
1259659|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
1259660|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
1259661|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
1259662|NCT00046228|E3|Reported Event|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
1259663|NCT00046228|E2|Reported Event|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
1259664|NCT00046228|E1|Reported Event|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
1259665|NCT00047463|B3|Baseline|Total|Total of all reporting groups
1259666|NCT00047463|B2|Baseline|Continuous Positive Airway Pressure|Continuous positive airway pressure is a standard treatment for obstructive sleep apnea that uses pressurized air delivered through a mask to keep the airway open and prevent obstruction during sleep.
1259667|NCT00047463|B1|Baseline|Placebo Continuous Positive Airway Pressure|With placebo continuous positive airway pressure, the subject feels like he/she is receiving the real treatment because of the presence of a blower and mask. However, there is a large leak that prevents the subject from receiving adequate pressurized air to keep the airway open.
1259668|NCT00047463|P2|Participant Flow|Continuous Positive Airway Pressure|Continuous positive airway pressure is a standard treatment for obstructive sleep apnea that uses pressurized air delivered through a mask to keep the airway open and prevent obstruction during sleep.
1259669|NCT00047463|P1|Participant Flow|Placebo Continuous Positive Airway Pressure|With placebo continuous positive airway pressure, the subject feels like he/she is receiving the real treatment because of the presence of a blower and mask. However, there is a large leak that prevents the subject from receiving adequate pressurized air to keep the airway open.
1259670|NCT00047463|O1|Outcome|All Participants Prior to Randomization|
1259671|NCT00047463|O2|Outcome|Placebo-CPAP|Placebo-CPAP: Placebo-CPAP
1259672|NCT00047463|O1|Outcome|Continuous Positive Airway Pressure (CPAP)|continuous positive airway pressure (CPAP): a mask treatment for sleep apnea
1259673|NCT00047463|O2|Outcome|Continuous Positive Airway Pressure|Continuous positive airway pressure is a standard treatment for obstructive sleep apnea that uses pressurized air delivered through a mask to keep the airway open and prevent obstruction during sleep.
1259674|NCT00047463|O1|Outcome|Placebo Continuous Positive Airway Pressure|With placebo continuous positive airway pressure, the subject feels like he/she is receiving the real treatment because of the presence of a blower and mask. However, there is a large leak that prevents the subject from receiving adequate pressurized air to keep the airway open.
1259675|NCT00047463|E2|Reported Event|Continuous Positive Airway Pressure|Continuous positive airway pressure is a standard treatment for obstructive sleep apnea that uses pressurized air delivered through a mask to keep the airway open and prevent obstruction during sleep.
1259676|NCT00047463|E1|Reported Event|Placebo Continuous Positive Airway Pressure|With placebo continuous positive airway pressure, the subject feels like he/she is receiving the real treatment because of the presence of a blower and mask. However, there is a large leak that prevents the subject from receiving adequate pressurized air to keep the airway open.
1259677|NCT00047385|B3|Baseline|Total|Total of all reporting groups
1259678|NCT00047385|B2|Baseline|Chest X-ray|Participants undergo chest x-ray examination.
1259679|NCT00047385|B1|Baseline|Low-Dose CT|Participants undergo low-dose helical CT examination.
1259680|NCT00047385|P2|Participant Flow|Chest X-ray|Participants undergo chest x-ray examination.
1259681|NCT00047385|P1|Participant Flow|Low-Dose CT|Participants undergo low-dose helical CT examination.
1259682|NCT00047385|O2|Outcome|CXR Screening|Participants randomized to receive three annual chest radiographs.
1259683|NCT00047385|O1|Outcome|LDCT Screening|Participants randomized to receive three annual low-dose helical CT exams of the chest.
1259684|NCT00047385|O2|Outcome|CXR Screening|Participants randomized to receive three annual chest radiographs.
1259685|NCT00047385|O1|Outcome|LDCT Screening|Participants randomized to receive three annual low-dose helical CT exams of the chest.
1259686|NCT00047385|O2|Outcome|CXR Screening|Participants randomized to receive three annual chest radiographs.
1259687|NCT00047385|O1|Outcome|LDCT Screening|Participants randomized to receive three annual low-dose helical CT exams of the chest.
1259688|NCT00047385|O2|Outcome|CXR Screening|Participants randomized to receive three annual chest radiographs.
1259689|NCT00047385|O1|Outcome|LDCT Screening|Participants randomized to receive three annual low-dose helical CT exams of the chest.
1259690|NCT00047385|O2|Outcome|CXR Screening|Participants randomized to receive three annual chest radiographs.
1259691|NCT00047385|O1|Outcome|LDCT Screening|Participants randomized to receive three annual low-dose helical CT exams of the chest.
1259692|NCT00047385|O2|Outcome|CXR Screening|Participants randomized to receive three annual chest radiographs.
1259693|NCT00047385|O1|Outcome|LDCT Screening|Participants randomized to receive three annual low-dose helical CT exams of the chest.
1259694|NCT00047385|O2|Outcome|CXR Screening|Participants randomized to receive three annual chest radiographs.
1259695|NCT00047385|O1|Outcome|LDCT Screening|Participants randomized to receive three annual low-dose helical CT exams of the chest.
1259696|NCT00047385|E2|Reported Event|Chest X-ray|Participants undergo chest x-ray examination.
1259697|NCT00047385|E1|Reported Event|Low-Dose CT|Participants undergo low-dose helical CT examination.
1259739|NCT00046891|O1|Outcome|Ginkgo Biloba|Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
1259740|NCT00046891|O2|Outcome|Placebo|Median change from baseline to different time points.
1259745|NCT00046891|O1|Outcome|Ginkgo Biloba|Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
1259746|NCT00046891|E2|Reported Event|Placebo|Placebo: Patients will take 1 tablet BID
1259698|NCT00047320|B1|Baseline|Radiation Therapy (CR From Induction)|"Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC > 750/L and platelets > 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy.~carboplatin: Given IV~etoposide: Given IV~ifosfamide: Given IV~radiation therapy: craniospinal irradiation"
1259699|NCT00047320|P1|Participant Flow|Radiation Therapy (CR From Induction)|"Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC > 750/L and platelets > 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy.~carboplatin: Given IV~etoposide: Given IV~ifosfamide: Given IV~radiation therapy: craniospinal irradiation"
1259700|NCT00047320|O1|Outcome|Radiation Therapy (CR From Induction)|"Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC > 750/L and platelets > 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy.~carboplatin: Given IV~etoposide: Given IV~ifosfamide: Given IV~thiotepa: Given IV~adjuvant therapy~conventional surgery~neoadjuvant therapy~peripheral blood stem cell transplantation~radiation therapy: craniospinal irradiation"
1259701|NCT00047320|E1|Reported Event|Radiation Therapy (CR From Induction)|"Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC > 750/L and platelets > 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy.~carboplatin: Given IV~etoposide: Given IV~ifosfamide: Given IV~radiation therapy: craniospinal irradiation"
1259702|NCT00047008|B3|Baseline|Total|Total of all reporting groups
1259703|NCT00047008|B2|Baseline|Accelerated Fractionation RT + Cisplatin|Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
1259704|NCT00047008|B1|Baseline|Standard Fractionation RT + Cisplatin|Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
1259705|NCT00047008|P2|Participant Flow|Accelerated Fractionation RT + Cisplatin|Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
1259706|NCT00047008|P1|Participant Flow|Standard Fractionation RT + Cisplatin|Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
1259707|NCT00047008|O2|Outcome|Accelerated Fractionation RT + Cisplatin|Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
1259708|NCT00047008|O1|Outcome|Standard Fractionation RT + Cisplatin|Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
1259709|NCT00047008|E2|Reported Event|Accelerated Fractionation RT + Cisplatin|Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
1259710|NCT00047008|E1|Reported Event|Standard Fractionation RT + Cisplatin|Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
1259711|NCT00046930|B3|Baseline|Total|Total of all reporting groups
1259712|NCT00046930|B2|Baseline|Placebo|Induction treatment with daunorubicin, cytarabine and placebo
1259713|NCT00046930|B1|Baseline|Zosuquidar|Induction treatment with daunorubicin, cytarabine and zosuquidar
1259714|NCT00046930|P2|Participant Flow|Placebo|Induction treatment with daunorubicin, cytarabine and placebo
1259715|NCT00046930|P1|Participant Flow|Zosuquidar|Induction treatment with daunorubicin, cytarabine and zosuquidar
1259716|NCT00046930|O2|Outcome|Placebo|Induction treatment with daunorubicin, cytarabine and placebo
1259717|NCT00046930|O1|Outcome|Zosuquidar|Induction treatment with daunorubicin, cytarabine and zosuquidar
1259718|NCT00046930|O2|Outcome|Placebo|Induction treatment with daunorubicin, cytarabine and placebo
1259719|NCT00046930|O1|Outcome|Zosuquidar|Induction treatment with daunorubicin, cytarabine and zosuquidar
1259720|NCT00046930|O2|Outcome|Placebo|Induction treatment with daunorubicin, cytarabine and placebo
1259721|NCT00046930|O1|Outcome|Zosuquidar|Induction treatment with daunorubicin, cytarabine and zosuquidar
1259722|NCT00046930|E5|Reported Event|Placebo Consolidation II|Consolidation with Daunorubicin, Cytarabine and Placebo
1259723|NCT00046930|E4|Reported Event|Zosuquidar Consolidation II|Consolidation with Daunorubicin, Cytarabine and Zosuquidar
1259724|NCT00046930|E3|Reported Event|Consolidation I|Cytarabine 1500 mg/m2 days 1-6
1259725|NCT00046930|E2|Reported Event|Placebo Induction|Induction treatment with daunorubicin, cytarabine and placebo
1259726|NCT00046930|E1|Reported Event|Zosuquidar Induction|Induction treatment with daunorubicin, cytarabine and zosuquidar
1259727|NCT00046891|B3|Baseline|Total|Total of all reporting groups
1259728|NCT00046891|B2|Baseline|Placebo|Placebo: Patients will take 1 tablet BID
1259729|NCT00046891|B1|Baseline|Ginkgo Biloba|Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
1259730|NCT00046891|P2|Participant Flow|Placebo|Placebo: Patients will take 1 tablet BID
1259731|NCT00046891|P1|Participant Flow|Ginkgo Biloba|Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
1259732|NCT00046891|O3|Outcome|Make Decisions|Self-report cognition
1259733|NCT00046891|O2|Outcome|Plan Ahead|Self-report cognition
1259734|NCT00046891|O1|Outcome|Solve Problems|Self-report cognition
1259735|NCT00046891|O3|Outcome|Balance Checkbook|Self-report cognition
1259747|NCT00046891|E1|Reported Event|Ginkgo Biloba|Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
1259748|NCT00046839|B3|Baseline|Total|Total of all reporting groups
1259749|NCT00046839|B2|Baseline|Experimental: Phase I/II: Celecoxib 400mg BID + RT|"COX-2 Inhibitor: Celecoxib 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
1259750|NCT00046839|B1|Baseline|Experimental: Phase I: Celecoxib 200mg BID + RT|"COX-2 Inhibitor: Celecoxib 200 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
1259751|NCT00046839|P2|Participant Flow|Experimental: Phase I/II: Celecoxib 400mg BID + RT|"COX-2 Inhibitor: Celecoxib 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
1259752|NCT00046839|P1|Participant Flow|Experimental: Phase I: Celecoxib 200mg BID + RT|"COX-2 Inhibitor: Celecoxib 200 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
1259753|NCT00046839|O1|Outcome|Experimental: Phase I/II: Celecoxib 200 or 400mg BID + RT|"COX-2 Inhibitor: Celecoxib 200 or 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
1259754|NCT00046839|O2|Outcome|Phase I: Celecoxib 400mg BID + RT|"COX-2 Inhibitor: Celecoxib 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy.~celecoxib~radiation therapy"
1259755|NCT00046839|O1|Outcome|Phase I: Celecoxib 200mg BID + RT|"COX-2 Inhibitor: Celecoxib 200 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy.~celecoxib~radiation therapy"
1259756|NCT00046839|E2|Reported Event|Experimental: Phase I/II: Celecoxib 400mg BID + RT|"COX-2 Inhibitor: Celecoxib 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
1259757|NCT00046839|E1|Reported Event|Experimental: Phase I: Celecoxib 200mg BID + RT|"COX-2 Inhibitor: Celecoxib 200 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
1259758|NCT00046475|B3|Baseline|Total|Total of all reporting groups
1259759|NCT00046475|B2|Baseline|Placebo/Midodrine|Participants received Placebo for 2 weeks, followed by 2 weeks of treatment with their optimum dose of Midodrine HCl
1259760|NCT00046475|B1|Baseline|Midodrine/Placebo|Participants received their optimum dose of Midodrine HCl for 2 weeks, followed by 2 weeks of treatment with Placebo
1259761|NCT00046475|P3|Participant Flow|Placebo/Midodrine|Participants received Placebo for 2 weeks, followed by 2 weeks of treatment with their optimum dose of Midodrine HCl
1259762|NCT00046475|P2|Participant Flow|Midodrine/Placebo|Participants received their optimum dose of Midodrine HCl for 2 weeks, followed by 2 weeks of treatment with Placebo
1259763|NCT00046475|P1|Participant Flow|All Enrolled Participants|All patients who were enrolled in this study are included in this population.
1259764|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
1259765|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
1259766|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
1259767|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
1259768|NCT00046475|O1|Outcome|ITT Population|All patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.
1259769|NCT00046475|O1|Outcome|ITT Population|All patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.
1259770|NCT00046475|O1|Outcome|ITT Population|All patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.
1259771|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
1259772|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
1259773|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
1259774|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
1259775|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
1259776|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
1259777|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
1259778|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
1259779|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
1259780|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
1259781|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
1259782|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
1259783|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
1259784|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
1259785|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
1259786|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
1259787|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
1259788|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
1259789|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
1259790|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
1259791|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
1259792|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
1259793|NCT00046475|E5|Reported Event|Follow-up|Patients were contacted 30 days after last study drug dose to follow up on any ongoing AEs and inquire if there were any new AEs.
1259794|NCT00046475|E4|Reported Event|Placebo|Patients received Placebo for 2 weeks.
1259795|NCT00046475|E3|Reported Event|Midodrine HCl|Patients received their optimum dose of Midodrine HCl for 2 weeks.
1259796|NCT00046475|E2|Reported Event|Titration|Patients received different doses of drug for at least 2 weeks to determine the maximum tolerated dose.
1259797|NCT00046475|E1|Reported Event|Screening/Washout|Patients signed the informed consent form and were screened for eligibility. Eligible patients were off drug for 1 week.
1259798|NCT00045734|B1|Baseline|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study/ laboratory biomarker analysis~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1259799|NCT00045734|P1|Participant Flow|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study/ laboratory biomarker analysis~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1259800|NCT00045734|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study/ laboratory biomarker analysis~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1259801|NCT00045734|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study/ laboratory biomarker analysis~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1259802|NCT00045734|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study/ laboratory biomarker analysis~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1259803|NCT00045734|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study/ laboratory biomarker analysis~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1259804|NCT00045734|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study/ laboratory biomarker analysis~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1259805|NCT00045734|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study/ laboratory biomarker analysis~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1259806|NCT00045734|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study/ laboratory biomarker analysis~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1259807|NCT00045734|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study/ laboratory biomarker analysis~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1259808|NCT00045734|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study/ laboratory biomarker analysis~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1259844|NCT00045487|B1|Baseline|OSI-774|Once-daily oral administration for 4 weeks.
1259845|NCT00045487|P1|Participant Flow|OSI-774|OSI-774, continuous daily oral administration of 150mg until disease progression or 52 weeks duration. Dose adjustment, reduction by increments of 50mg will be made for dose-limiting toxicity.
1259809|NCT00045734|E1|Reported Event|Treatment (Imatinib Mesylate)|"Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study/ laboratory biomarker analysis~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
1259810|NCT00045708|B4|Baseline|Total|Total of all reporting groups
1259811|NCT00045708|B3|Baseline|Phase 2|Phase II: Once the MTD is determined, additional patients receive ixabepilone at the MTD.
1259812|NCT00045708|B2|Baseline|Group B [No Anticonvulsants] - Phase 1|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.~Pharmacological Study~ixabepilone: Given IV~pharmacological study: Correlative studies"
1259813|NCT00045708|B1|Baseline|Group A [Anticonvulsants] - Phase 1|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.~Pharmacological Study~ixabepilone: Given IV pharmacological study: Correlative studies"
1259814|NCT00045708|P3|Participant Flow|Group 3 - MTD Phase 2|Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.
1259815|NCT00045708|P2|Participant Flow|Group B [No Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.~Pharmacological Study~ixabepilone: Given IV~pharmacological study: Correlative studies"
1259816|NCT00045708|P1|Participant Flow|Group A [Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.~Pharmacological Study~ixabepilone: Given IV~pharmacological study: Correlative studies"
1259817|NCT00045708|O1|Outcome|Phase 2|Phase II: Once the MTD is determined, additional patients receive ixabepilone at the MTD.
1259818|NCT00045708|O1|Outcome|Phase 2|Phase II: Once the MTD is determined, additional patients receive ixabepilone at the MTD (6.8mg/m2).
1259819|NCT00045708|O3|Outcome|Phase 2|Phase II: Once the MTD is determined, additional patients receive ixabepilone at the MTD.
1259820|NCT00045708|O2|Outcome|Group B [No Anticonvulsants] Phase 1|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.~Pharmacological Study~ixabepilone: Given IV~pharmacological study: Correlative studies"
1259821|NCT00045708|O1|Outcome|Group A [Anticonvulsants] Phase 1|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Pharmacological Study Phase 1"
1259822|NCT00045708|O3|Outcome|Phase 2|Phase II: Once the MTD is determined, additional patients receive ixabepilone at the MTD.
1259823|NCT00045708|O2|Outcome|Group B [No Anticonvulsants] - Phase 1|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.~Pharmacological Study~ixabepilone: Given IV~pharmacological study: Correlative studies"
1259824|NCT00045708|O1|Outcome|Group A [Anticonvulsants] - Phase 1|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.~Pharmacological Study~ixabepilone: Given IV pharmacological study: Correlative studies"
1259825|NCT00045708|O1|Outcome|Phase 2|Phase II: Once the MTD is determined, additional patients receive ixabepilone at the MTD.
1259826|NCT00045708|O2|Outcome|Group B [No Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Pharmacological Study Phase 1~ixabepilone: Given IV~pharmacological study: Correlative studies"
1259843|NCT00045630|E1|Reported Event|Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery|Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m^2 of gemcitabine IV and 80 mg/m^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
1259827|NCT00045708|O1|Outcome|Group A [Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Pharmacological Study Phase 1~ixabepilone: Given IV~pharmacological study: Correlative studies"
1259828|NCT00045708|O2|Outcome|Group B [No Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Pharmacological Study Phase 1~ixabepilone: Given IV~pharmacological study: Correlative studies"
1259829|NCT00045708|O1|Outcome|Group A [Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Pharmacological Study Phase 1~ixabepilone: Given IV~pharmacological study: Correlative studies"
1259830|NCT00045708|O2|Outcome|Group B [No Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Pharmacological Study Phase 1~ixabepilone: Given IV~pharmacological study: Correlative studies"
1259831|NCT00045708|O1|Outcome|Group A [Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Pharmacological Study Phase 1~ixabepilone: Given IV~pharmacological study: Correlative studies"
1259832|NCT00045708|O3|Outcome|Group 3 - MTD (6.8mg/m2/Day) Phase 2|"Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.~ixabepilone: Given IV~MTD for no anticonvulsant arm = 6.8mg/m2/day MTD for anticonvulsant arm = 9.6mg/m2/day~Only no anticonvulsant subjects at 6.8mg/m2/day treated in Phase 2"
1259833|NCT00045708|O2|Outcome|Group B [No Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Pharmacological Study~ixabepilone: Given IV~pharmacological study: Correlative studies"
1259834|NCT00045708|O1|Outcome|Group A [Anticonvulsants]|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Pharmacological Study~ixabepilone: Given IV~pharmacological study: Correlative studies"
1259835|NCT00045708|E3|Reported Event|Phase 2|Phase II: Once the MTD is determined, additional patients receive ixabepilone at the MTD.
1259836|NCT00045708|E2|Reported Event|Group B [No Anticonvulsants] - Phase 1|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.~Pharmacological Study~ixabepilone: Given IV~pharmacological study: Correlative studies"
1259837|NCT00045708|E1|Reported Event|Group A [Anticonvulsants] - Phase 1|"Phase I: Dose Escalation - Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.~Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.~Pharmacological Study~ixabepilone: Given IV pharmacological study: Correlative studies"
1259838|NCT00045630|B1|Baseline|Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery|Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m^2 of gemcitabine IV and 80 mg/m^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
1259839|NCT00045630|P1|Participant Flow|Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery|Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m^2 of gemcitabine IV and 80 mg/m^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
1259840|NCT00045630|O1|Outcome|Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery|Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m^2 of gemcitabine IV and 80 mg/m^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
1259841|NCT00045630|O1|Outcome|Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery|Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m^2 of gemcitabine IV and 80 mg/m^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
1259842|NCT00045630|O1|Outcome|Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery|Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m^2 of gemcitabine IV and 80 mg/m^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
1259846|NCT00045487|O1|Outcome|OSI-774|Once-daily oral administration for 4 weeks.
1259847|NCT00045487|E1|Reported Event|OSI-774|Once-daily oral administration for 4 weeks.
1259848|NCT00045435|B1|Baseline|Treatment (Nonmyeloablative Donor PBSC Transplant)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.~Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant~Fludarabine phosphate: Given IV~Total-body irradiation: Undergo total-body irradiation~Cyclosporine: Given PO~Mycophenolate mofetil: Given PO~Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant"
1259849|NCT00045435|P1|Participant Flow|Treatment (Nonmyeloablative Donor PBSC Transplant)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.~Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant~Fludarabine phosphate: Given IV~Total-body irradiation: Undergo total-body irradiation~Cyclosporine: Given PO~Mycophenolate mofetil: Given PO~Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant"
1259850|NCT00045435|O1|Outcome|Treatment (Nonmyeloablative Donor PBSC Transplant)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.~Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant~Fludarabine phosphate: Given IV~Total-body irradiation: Undergo total-body irradiation~Cyclosporine: Given PO~Mycophenolate mofetil: Given PO~Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant"
1259851|NCT00045435|O1|Outcome|Treatment (Nonmyeloablative Donor PBSC Transplant)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.~Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant~Fludarabine phosphate: Given IV~Total-body irradiation: Undergo total-body irradiation~Cyclosporine: Given PO~Mycophenolate mofetil: Given PO~Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant"
1259852|NCT00045435|O1|Outcome|Treatment (Nonmyeloablative Donor PBSC Transplant)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.~Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant~Fludarabine phosphate: Given IV~Total-body irradiation: Undergo total-body irradiation~Cyclosporine: Given PO~Mycophenolate mofetil: Given PO~Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant"
1259853|NCT00045435|O1|Outcome|Treatment (Nonmyeloablative Donor PBSC Transplant)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.~Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant~Fludarabine phosphate: Given IV~Total-body irradiation: Undergo total-body irradiation~Cyclosporine: Given PO~Mycophenolate mofetil: Given PO~Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant"
1259854|NCT00045435|O1|Outcome|Treatment (Nonmyeloablative Donor PBSC Transplant)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.~Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant~Fludarabine phosphate: Given IV~Total-body irradiation: Undergo total-body irradiation~Cyclosporine: Given PO~Mycophenolate mofetil: Given PO~Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant"
1259855|NCT00045435|O1|Outcome|Treatment (Nonmyeloablative Donor PBSC Transplant)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.~Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant~Fludarabine phosphate: Given IV~Total-body irradiation: Undergo total-body irradiation~Cyclosporine: Given PO~Mycophenolate mofetil: Given PO~Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant"
1259856|NCT00045435|E1|Reported Event|Treatment (Nonmyeloablative Donor PBSC Transplant)|"Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI & allogeneic PBSC transplant on day 0. Patients also receive CSP PO BID on days -3 to 56 with taper to day 77, and MMF PO BID on days 0-27.~Nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant~Fludarabine phosphate: Given IV~Total-body irradiation: Undergo total-body irradiation~Cyclosporine: Given PO~Mycophenolate mofetil: Given PO~Peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood stem cell transplant"
1259891|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259893|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1259924|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1259857|NCT00045305|B1|Baseline|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.~Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.~Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD."
1259858|NCT00045305|P1|Participant Flow|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.~Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.~Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD."
1259859|NCT00045305|O1|Outcome|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.~Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.~Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.~Cyclosporine: Immunosuppressant~Methotrexate: Antimetabolite"
1259860|NCT00045305|O1|Outcome|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.~Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.~Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.~Cyclosporine: Immunosuppressant~Methotrexate: Antimetabolite"
1259861|NCT00045305|O1|Outcome|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.~Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.~Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.~Cyclosporine: Immunosuppressant~Methotrexate: Antimetabolite"
1259862|NCT00045305|O1|Outcome|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.~Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.~Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.~Cyclosporine: Immunosuppressant~Methotrexate: Antimetabolite"
1259863|NCT00045305|O1|Outcome|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.~Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.~Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.~Cyclosporine: Immunosuppressant~Methotrexate: Antimetabolite"
1259892|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1260029|NCT00043186|P3|Participant Flow|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1259864|NCT00045305|O1|Outcome|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.~Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.~Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.~Cyclosporine: Immunosuppressant~Methotrexate: Antimetabolite"
1259865|NCT00045305|E1|Reported Event|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.~Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.~Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD."
1259866|NCT00045162|B3|Baseline|Total|Total of all reporting groups
1259867|NCT00045162|B2|Baseline|Cisplatin + Etoposide|
1259868|NCT00045162|B1|Baseline|Cisplatin + Irinotecan|
1259869|NCT00045162|P2|Participant Flow|Cisplatin + Etoposide|
1259870|NCT00045162|P1|Participant Flow|Cisplatin + Irinotecan|
1259871|NCT00045162|O2|Outcome|Cisplatin + Etoposide|
1259872|NCT00045162|O1|Outcome|Cisplatin + Irinotecan|
1259873|NCT00045162|O2|Outcome|Cisplatin + Etoposide|
1259874|NCT00045162|O1|Outcome|Cisplatin + Irinotecan|
1259875|NCT00045162|O2|Outcome|Cisplatin + Etoposide|
1259876|NCT00045162|O1|Outcome|Cisplatin + Irinotecan|
1259877|NCT00045162|O2|Outcome|Cisplatin + Etoposide|
1259878|NCT00045162|O1|Outcome|Cisplatin + Irinotecan|
1259879|NCT00045162|E2|Reported Event|Cisplatin + Etoposide|
1259880|NCT00045162|E1|Reported Event|Cisplatin + Irinotecan|
1259881|NCT00045032|B4|Baseline|Total|Total of all reporting groups
1259882|NCT00045032|B3|Baseline|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259883|NCT00045032|B2|Baseline|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259884|NCT00045032|B1|Baseline|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1259885|NCT00045032|P3|Participant Flow|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259886|NCT00045032|P2|Participant Flow|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259887|NCT00045032|P1|Participant Flow|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1259888|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259889|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259890|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1260278|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1259894|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259895|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259896|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259897|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259898|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259899|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259900|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259901|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259902|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259903|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259904|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1259905|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259906|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259907|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1259908|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259909|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259910|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259911|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259912|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259913|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259914|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1259915|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259916|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259917|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1259918|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259919|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259920|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259921|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259922|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259923|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259925|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259926|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259927|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1259928|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259929|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259930|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259931|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259932|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259933|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259934|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1259935|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259936|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259937|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1259938|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259986|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1260314|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260030|NCT00043186|P2|Participant Flow|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260635|NCT00041756|E3|Reported Event|50 mg PG-530742|50 mg PG-530742 dosed BID
1259939|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259940|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259941|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259942|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259943|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259944|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1259945|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259946|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259947|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1259948|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259949|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259950|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1259951|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259952|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259953|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1260003|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1260350|NCT00043186|E6|Reported Event|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1259954|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259955|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1259956|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259957|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1259958|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259959|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1259960|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259961|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1259962|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259963|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259964|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259965|NCT00045032|O1|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259966|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259967|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259968|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1259969|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1260619|NCT00041756|P4|Participant Flow|100 mg PG-530742|100 mg PG-530742 dosed BID
1259970|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259971|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1259972|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259973|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259974|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1259975|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259976|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259977|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1259978|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259979|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259980|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1259981|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259982|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259983|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1259984|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259985|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1260620|NCT00041756|P3|Participant Flow|50 mg PG-530742|50 mg PG-530742 dosed BID
1259987|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259988|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259989|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1259990|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259991|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259992|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1259993|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259994|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259995|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1259996|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259997|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1259998|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1259999|NCT00045032|O3|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1260000|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1260001|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1260002|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1260621|NCT00041756|P2|Participant Flow|25 mg PG-530742|25 mg PG-530742 dosed BID
1260004|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1260005|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1260006|NCT00045032|O2|Outcome|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1260007|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1260008|NCT00045032|O2|Outcome|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1260009|NCT00045032|O1|Outcome|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
1260010|NCT00045032|E3|Reported Event|Herceptin 2-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1260011|NCT00045032|E2|Reported Event|Herceptin 1-Year Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
1260012|NCT00045032|E1|Reported Event|Observation Arm|Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided. After the release of initial study results, participants in the Observation Arm were allowed to cross over to receive adjuvant Herceptin prior to disease recurrence. As such, adverse events that occurred after crossover were not included in the safety analyses for this arm.
1260013|NCT00043186|B10|Baseline|Total|Total of all reporting groups
1260014|NCT00043186|B9|Baseline|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260015|NCT00043186|B8|Baseline|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260016|NCT00043186|B7|Baseline|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260017|NCT00043186|B6|Baseline|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260018|NCT00043186|B5|Baseline|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260019|NCT00043186|B4|Baseline|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260020|NCT00043186|B3|Baseline|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260021|NCT00043186|B2|Baseline|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260022|NCT00043186|B1|Baseline|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260023|NCT00043186|P9|Participant Flow|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260024|NCT00043186|P8|Participant Flow|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260025|NCT00043186|P7|Participant Flow|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260026|NCT00043186|P6|Participant Flow|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260027|NCT00043186|P5|Participant Flow|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260028|NCT00043186|P4|Participant Flow|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260031|NCT00043186|P1|Participant Flow|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260032|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260033|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260034|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260035|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260036|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260037|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260038|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260039|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260040|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260041|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260042|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260043|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260044|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260045|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260046|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260047|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260048|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260049|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260050|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260051|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260052|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260053|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260054|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260055|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260056|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260057|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260058|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260059|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260060|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260061|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260062|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260063|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260064|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260622|NCT00041756|P1|Participant Flow|Placebo Tablet|Placebo tablet dosed BID
1260065|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260066|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260067|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260068|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260069|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260070|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260071|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260072|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260073|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260074|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260075|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260076|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260077|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260078|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260079|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260080|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260081|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260082|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260083|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260084|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260085|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260086|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260087|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260088|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260089|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260090|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260091|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260092|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260093|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260094|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260095|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260096|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260097|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260098|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260099|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260135|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260171|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260100|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260101|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260102|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260103|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260104|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260105|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260106|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260107|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260108|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260109|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260110|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260111|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260112|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260113|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260114|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260115|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260116|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260117|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260118|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260119|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260120|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260121|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260122|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260123|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260124|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260125|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260126|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260127|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260128|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260129|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260130|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260131|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260132|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260133|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260134|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260206|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260136|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260137|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260138|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260139|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260140|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260141|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260142|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260143|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260144|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260145|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260146|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260147|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260148|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260149|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260150|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260151|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260152|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260153|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260154|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260155|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260156|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260157|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260158|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260159|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260160|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260161|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260162|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260163|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260164|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260165|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260166|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260167|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260168|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260169|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260170|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260242|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260172|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260173|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260174|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260175|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260176|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260177|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260178|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260179|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260180|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260181|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260182|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260183|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260184|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260185|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260186|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260187|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260188|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260189|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260190|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260191|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260192|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260193|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260194|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260195|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260196|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260197|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260198|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260199|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260200|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260201|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260202|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260203|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260204|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260205|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260623|NCT00041756|O5|Outcome|200 mg PG-530742|200 mg PG-530742 dosed BID
1260207|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260208|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260209|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260210|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260211|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260212|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260213|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260214|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260215|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260216|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260217|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260218|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260219|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260220|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260221|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260222|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260223|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260224|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260225|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260226|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260227|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260228|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260229|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260230|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260231|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260232|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260233|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260234|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260235|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260236|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260237|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260238|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260239|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260240|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260241|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260624|NCT00041756|O4|Outcome|100 mg PG-530742|100 mg PG-530742 dosed BID
1260243|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260244|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260245|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260246|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260247|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260248|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260249|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260250|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260251|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260252|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260253|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260254|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260255|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260256|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260257|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260258|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260259|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260260|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260261|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260262|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260263|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260264|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260265|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260266|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260267|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260268|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260269|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260270|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260271|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260272|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260273|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260274|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260275|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260276|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260277|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260625|NCT00041756|O3|Outcome|50 mg PG-530742|50 mg PG-530742 dosed BID
1260279|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260280|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260281|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260282|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260283|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260284|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260285|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260286|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260287|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260288|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260289|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260290|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260291|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260292|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260293|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260294|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260295|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260296|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260297|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260298|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260299|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260300|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260301|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260302|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260303|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260304|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260305|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260306|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260307|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260308|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260309|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260310|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260311|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260312|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260313|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260626|NCT00041756|O2|Outcome|25 mg PG-530742|25 mg PG-530742 dosed BID
1260315|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260316|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260317|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260318|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260319|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260320|NCT00043186|O1|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260321|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260322|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260323|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260324|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260325|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260326|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260327|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260328|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260329|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260330|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260331|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260332|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260333|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260334|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260335|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260336|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260337|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260338|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260339|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260340|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260341|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
1260342|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260343|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260344|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260345|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260346|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260347|NCT00043186|E9|Reported Event|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
1260348|NCT00043186|E8|Reported Event|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
1260349|NCT00043186|E7|Reported Event|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260351|NCT00043186|E5|Reported Event|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260352|NCT00043186|E4|Reported Event|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
1260353|NCT00043186|E3|Reported Event|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260354|NCT00043186|E2|Reported Event|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
1260355|NCT00043186|E1|Reported Event|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
1260356|NCT00044655|B3|Baseline|Total|Total of all reporting groups
1260357|NCT00044655|B2|Baseline|Switch|Participants will change medications from medication prescribed at study entry
1260358|NCT00044655|B1|Baseline|Stay|Participants will continue taking medication prescribed at study entry
1260359|NCT00044655|P2|Participant Flow|Switch|Participants will change medications from medication prescribed at study entry
1260360|NCT00044655|P1|Participant Flow|Stay|Participants will continue taking medication prescribed at study entry
1260361|NCT00044655|O2|Outcome|Switch|Participants will change medications from medication prescribed at study entry
1260362|NCT00044655|O1|Outcome|Stay|Participants will continue taking medication prescribed at study entry
1260363|NCT00044655|E2|Reported Event|Switch|Participants will change medications from medication prescribed at study entry
1260364|NCT00044655|E1|Reported Event|Stay|Participants will continue taking medication prescribed at study entry
1260365|NCT00044512|B1|Baseline|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
1260366|NCT00044512|P1|Participant Flow|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
1260367|NCT00044512|O1|Outcome|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
1260368|NCT00044512|O1|Outcome|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
1260369|NCT00044512|O1|Outcome|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
1260370|NCT00044512|O1|Outcome|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
1260371|NCT00044512|O1|Outcome|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
1260372|NCT00044512|O1|Outcome|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
1260373|NCT00044512|O1|Outcome|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
1260374|NCT00044512|O1|Outcome|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
1260375|NCT00044512|E1|Reported Event|Sorafenib 400 mg b.i.d.|"Sorafenib (Nexavar, BAY43-9006) 400 mg administered b.i.d.Other AE section includes SAEs"
1260376|NCT00042991|B8|Baseline|Total|Total of all reporting groups
1260377|NCT00042991|B7|Baseline|Stratum-2: 100 mg/m^2 of Gefitinib + Radiation + EIACD|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 100 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
1260378|NCT00042991|B6|Baseline|Stratum-1B: 375 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and NOT receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 375 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
1260379|NCT00042991|B5|Baseline|Stratum-1B: 250 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and NOT receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 250 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
1260380|NCT00042991|B4|Baseline|Stratum-1B: 100 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and NOT receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 100 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
1260381|NCT00042991|B3|Baseline|Stratum 1A-375 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed brain stem glioma who were treated at Dose 375 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
1260382|NCT00042991|B2|Baseline|Stratum 1A-250 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed brain stem glioma who were treated at Dose 250 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
1260383|NCT00042991|B1|Baseline|Stratum 1A-100 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed brain stem glioma who were treated at Dose 100 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
1260384|NCT00042991|P7|Participant Flow|Stratum-2: 100 mg/m^2 of Gefitinib + Radiation + EIACD|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 100 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
1260385|NCT00042991|P6|Participant Flow|Stratum-1B: 375 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and NOT receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 375 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
1260386|NCT00042991|P5|Participant Flow|Stratum-1B: 250 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and NOT receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 250 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
1260627|NCT00041756|O1|Outcome|Placebo Tablet|Placebo tablet dosed BID
1260628|NCT00041756|O5|Outcome|200 mg PG-530742|200 mg PG-530742 dosed BID
1260633|NCT00041756|E5|Reported Event|200 mg PG-530742|200 mg PG-530742 dosed BID
1260634|NCT00041756|E4|Reported Event|100 mg PG-530742|100 mg PG-530742 dosed BID
1260387|NCT00042991|P4|Participant Flow|Stratum-1B: 100 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and NOT receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 100 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
1260388|NCT00042991|P3|Participant Flow|Stratum 1A-375 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed brain stem glioma who were treated at Dose 375 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
1260389|NCT00042991|P2|Participant Flow|Stratum 1A-250 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed brain stem glioma who were treated at Dose 250 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
1260390|NCT00042991|P1|Participant Flow|Stratum 1A-100 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed brain stem glioma who were treated at Dose 100 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
1260391|NCT00042991|O1|Outcome|Stratum IB and Stratum II|Activation and mutations of EGFR have been associated with many cancers. In this secondary objective, we identify how many patients have activated EGFR and this requires a tumor sample from patients, which is only available from supratentorial malignant glioma patients treated on Stratum IB and Stratum II.
1260392|NCT00042991|O4|Outcome|Dose 375 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 375 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight of 12 patients had adequate PK samples for the PK evaluation.
1260393|NCT00042991|O3|Outcome|Dose 100 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 100 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight (8) of 10 patients had adequate PK samples for the PK evaluation.
1260394|NCT00042991|O2|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase I)|This cohort includes all Phase-I patients treated at 250 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Only six of 11 patients had adequate PK samples for the PK evaluation.
1260395|NCT00042991|O1|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase II, Brain Stem Gliomas)|Brain Stem Glioma patients treated on the Phase-II trial. Seven patients were treated during Phase-I at the Phase-II dose, and thus eligible for the Phase-II trial, and included in this part of the report. Only 18 patients had samples for the PK evaluation.
1260396|NCT00042991|O4|Outcome|Dose 375 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 375 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight of 12 patients had adequate PK samples for the PK evaluation.
1260397|NCT00042991|O3|Outcome|Dose 100 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 100 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight (8) of 10 patients had adequate PK samples for the PK evaluation.
1260398|NCT00042991|O2|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase I)|This cohort includes all Phase-I patients treated at 250 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Only six of 11 patients had adequate PK samples for the PK evaluation.
1260399|NCT00042991|O1|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase II, Brain Stem Gliomas)|Brain Stem Glioma patients treated on the Phase-II trial. Seven patients were treated during Phase-I at the Phase-II dose, and thus eligible for the Phase-II trial, and included in this part of the report. Only 18 patients had samples for the PK evaluation.
1260400|NCT00042991|O4|Outcome|Dose 375 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 375 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight of 12 patients had adequate PK samples for the PK evaluation.
1260401|NCT00042991|O3|Outcome|Dose 100 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 100 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight (8) of 10 patients had adequate PK samples for the PK evaluation.
1260402|NCT00042991|O2|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase I)|This cohort includes all Phase-I patients treated at 250 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Only six of 11 patients had adequate PK samples for the PK evaluation.
1260403|NCT00042991|O1|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase II, Brain Stem Gliomas)|Brain Stem Glioma patients treated on the Phase-II trial. Seven patients were treated during Phase-I at the Phase-II dose, and thus eligible for the Phase-II trial, and included in this part of the report. Only 18 patients had samples for the PK evaluation.
1260404|NCT00042991|O4|Outcome|Dose 375 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 375 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight of 12 patients had adequate PK samples for the PK evaluation.
1260405|NCT00042991|O3|Outcome|Dose 100 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 100 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight (8) of 10 patients had adequate PK samples for the PK evaluation.
1260406|NCT00042991|O2|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase I)|This cohort includes all Phase-I patients treated at 250 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Only six of 11 patients had adequate PK samples for the PK evaluation.
1260407|NCT00042991|O1|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase II, Brain Stem Gliomas)|Brain Stem Glioma patients treated on the Phase-II trial. Seven patients were treated during Phase-I at the Phase-II dose, and thus eligible for the Phase-II trial, and included in this part of the report. Only 18 patients had samples for the PK evaluation.
1260408|NCT00042991|O4|Outcome|Dose 375 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 375 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight of 12 patients had adequate PK samples for the PK evaluation.
1260409|NCT00042991|O3|Outcome|Dose 100 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 100 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight (8) of 10 patients had adequate PK samples for the PK evaluation.
1260410|NCT00042991|O2|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase I)|This cohort includes all Phase-I patients treated at 250 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Only six of 11 patients had adequate PK samples for the PK evaluation.
1260411|NCT00042991|O1|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase II, Brain Stem Gliomas)|Brain Stem Glioma patients treated on the Phase-II trial. Seven patients were treated during Phase-I at the Phase-II dose, and thus eligible for the Phase-II trial, and included in this part of the report. Only 18 patients had samples for the PK evaluation.
1260412|NCT00042991|O1|Outcome|Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation|This analysis includes patients with newly diagnosed Brain Stem Glioma patients who received Dose 250 mg/m^2 of Gefitinib+Radiation.
1260413|NCT00042991|O1|Outcome|Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation|This analysis includes patients with newly diagnosed Brain Stem Glioma patients who received Dose 250 mg/m^2 of Gefitinib+Radiation.
1260414|NCT00042991|O1|Outcome|Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation|This analysis includes patients with newly diagnosed Brain Stem Glioma patients who received Dose 250 mg/m^2 of Gefitinib+Radiation.
1260415|NCT00042991|O1|Outcome|Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation|This analysis includes patients with newly diagnosed Brain Stem Glioma patients who received Dose 250 mg/m^2 of Gefitinib+Radiation.
1260416|NCT00042991|O1|Outcome|Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation|This analysis includes patients with newly diagnosed Brain Stem Glioma patients who received Dose 250 mg/m^2 of Gefitinib+Radiation.
1260417|NCT00042991|O1|Outcome|Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation|This analysis includes patients with newly diagnosed Brain Stem Glioma patients who received Dose 250 mg/m^2 of Gefitinib+Radiation.
1260418|NCT00042991|O1|Outcome|Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation|This analysis includes patients with newly diagnosed Brain Stem Glioma patients who received Dose 250 mg/m^2 of Gefitinib+Radiation.
1260419|NCT00042991|O1|Outcome|Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation|This analysis includes patients with newly diagnosed Brain Stem Glioma patients who received Dose 250 mg/m^2 of Gefitinib+Radiation.
1260420|NCT00042991|O3|Outcome|Stratum 1A-375 mg/m^2 of Gefitinib + Radiation|These are patients with brain stem glioma who were treated during the Phase-I trial of Radiation+Dose 375 mg/m^2 of Gefitinib, where Gefitinib was administered orally once daily.
1260421|NCT00042991|O2|Outcome|Stratum 1A-250 mg/m^2 of Gefitinib + Radiation|These are patients with brain stem glioma who were treated during the Phase-I trial of Radiation+Dose 250 mg/m^2 of Gefitinib, where Gefitinib was administered orally once daily.
1260422|NCT00042991|O1|Outcome|Stratum 1A-100 mg/m^2 of Gefitinib + Radiation|These are patients with brain stem glioma who were treated during the Phase-I trial of Radiation+Dose 100 mg/m^2 of Gefitinib, where Gefitinib was administered orally once daily.
1260423|NCT00042991|E7|Reported Event|Stratum II at Dose 100 mg/m^2|Patients with STMG treated at 100 mg/m2 who are receiving EIACD
1260424|NCT00042991|E6|Reported Event|Stratum IB at Dose 375 mg/m^2|Patients with STMG treated at 375 mg/m2
1260425|NCT00042991|E5|Reported Event|Stratum IB at Dose 250 mg/m^2|Patients with STMG treated at 250 mg/m2
1260426|NCT00042991|E4|Reported Event|Stratum IB at Dose 100 mg/m^2|Patients with STMG treated at 100 mg/m2
1260427|NCT00042991|E3|Reported Event|Stratum IA at Dose 375 mg/m^2|Brain Stem Glioma patients treated at 375 mg/m2
1260428|NCT00042991|E2|Reported Event|Stratum IA at Dose 250 mg/m^2|Brain Stem Glioma patients treated at 250 mg/m2
1260429|NCT00042991|E1|Reported Event|Stratum IA at Dose 100 mg/m^2|Brain Stem Glioma patients treated at 100 mg/m2
1260430|NCT00042939|B3|Baseline|Total|Total of all reporting groups
1260431|NCT00042939|B2|Baseline|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.~On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
1260432|NCT00042939|B1|Baseline|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
1260433|NCT00042939|P2|Participant Flow|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.~On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
1260434|NCT00042939|P1|Participant Flow|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
1260629|NCT00041756|O4|Outcome|100 mg PG-530742|100 mg PG-530742 dosed BID
1260630|NCT00041756|O3|Outcome|50 mg PG-530742|50 mg PG-530742 dosed BID
1260435|NCT00042939|O2|Outcome|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.~On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
1260436|NCT00042939|O1|Outcome|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
1260437|NCT00042939|O2|Outcome|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.~On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
1260438|NCT00042939|O1|Outcome|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
1260439|NCT00042939|O2|Outcome|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.~On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
1260440|NCT00042939|O1|Outcome|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
1260441|NCT00042939|O2|Outcome|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.~On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
1260442|NCT00042939|O1|Outcome|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
1260443|NCT00042939|O2|Outcome|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.~On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
1260475|NCT00044044|P4|Participant Flow|10 mg Haloperidol|10 mg Haloperidol overencapsulated tablet taken orally once a day. The number of subjects in the participant flow for the haloperidol 10mg group(overall study) is based on the total number of subjects randomized in this treatment group.
1260631|NCT00041756|O2|Outcome|25 mg PG-530742|25 mg PG-530742 dosed BID
1260444|NCT00042939|O1|Outcome|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
1260445|NCT00042939|E2|Reported Event|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.~On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
1260446|NCT00042939|E1|Reported Event|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
1260447|NCT00044213|B5|Baseline|Total|Total of all reporting groups
1260448|NCT00044213|B4|Baseline|EDTA Placebo + High Dose Vitamin Placebo|Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
1260449|NCT00044213|B3|Baseline|EDTA Placebo + High Dose Vitamin|Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
1260450|NCT00044213|B2|Baseline|EDTA + High Dose Vitamin Placebo|Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
1260451|NCT00044213|B1|Baseline|EDTA + High Dose Vitamin|Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
1260452|NCT00044213|P4|Participant Flow|EDTA Placebo + High Dose Vitamin Placebo|Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
1260453|NCT00044213|P3|Participant Flow|EDTA Placebo + High Dose Vitamin|Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
1260454|NCT00044213|P2|Participant Flow|EDTA + High Dose Vitamin Placebo|Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
1260455|NCT00044213|P1|Participant Flow|EDTA + High Dose Vitamin|Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
1260456|NCT00044213|O4|Outcome|EDTA Placebo + High Dose Vitamin Placebo|Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
1260457|NCT00044213|O3|Outcome|EDTA Placebo + High Dose Vitamin|Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
1260458|NCT00044213|O2|Outcome|EDTA + High Dose Vitamin Placebo|Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
1260459|NCT00044213|O1|Outcome|EDTA + High Dose Vitamin|Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
1260460|NCT00044213|O4|Outcome|EDTA Placebo + High Dose Vitamin Placebo|Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
1260461|NCT00044213|O3|Outcome|EDTA Placebo + High Dose Vitamin|Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
1260462|NCT00044213|O2|Outcome|EDTA + High Dose Vitamin Placebo|Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
1260463|NCT00044213|O1|Outcome|EDTA + High Dose Vitamin|Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
1260464|NCT00044213|E4|Reported Event|EDTA Placebo + High Dose Vitamin Placebo|Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
1260465|NCT00044213|E3|Reported Event|EDTA Placebo + High Dose Vitamin|Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
1260466|NCT00044213|E2|Reported Event|EDTA + High Dose Vitamin Placebo|Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
1260467|NCT00044213|E1|Reported Event|EDTA + High Dose Vitamin|Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
1260468|NCT00044044|B6|Baseline|Total|Total of all reporting groups
1260469|NCT00044044|B5|Baseline|Placebo|Oral Capsule matching treatment group taken oce a day
1260470|NCT00044044|B4|Baseline|10 mg Haloperidol|10 mg Haloperidol overencapsulated tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (356). The number of subjects in the baseline characteristics is based on the safety population (353). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 10 mg haloperidol treatment group did not take any study medication.
1260471|NCT00044044|B3|Baseline|80 mg|Lurasidone 80 mg oral tablet taken once a day
1260472|NCT00044044|B2|Baseline|40 mg|Lurasidone 40 mg oral tablet taken once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (356). The number of subjects in the baseline characteristics is based on the safety population (353). All randomized subjects who received at least one dose of study medication were included in the safety analysis. Two subjects who were randomized to the 40 mg treatment group did not take any study medication.
1260473|NCT00044044|B1|Baseline|20 mg|Lurasidone 20 mg oral tablet taken once a day
1260474|NCT00044044|P5|Participant Flow|Placebo|Oral Capsule matching treatment group taken oce a day. The number of subjects in the participant flow for the placebo group(overall study) is based on the total number of subjects randomized in this treatment group.
1260476|NCT00044044|P3|Participant Flow|80 mg|Lurasidone 80 mg oral tablet taken once a day. The number of subjects in the participant flow for the lurasidone 80mg group(overall study) is based on the total number of subjects randomized in this treatment group.
1260477|NCT00044044|P2|Participant Flow|40 mg|Lurasidone 40 mg oral tablet taken once a day. The number of subjects in the participant flow for the lurasidone 40mg group(overall study) is based on the total number of subjects randomized in this treatment group.
1260478|NCT00044044|P1|Participant Flow|20 mg|Lurasidone 20 mg oral tablet taken once a day. The number of subjects in the participant flow for the lurasidone 20mg group(overall study) is based on the total number of subjects randomized in this treatment group.
1260479|NCT00044044|O5|Outcome|Placebo|Oral Capsule matching treatment group taken oce a day
1260480|NCT00044044|O4|Outcome|10 mg Haloperidol|10 mg Haloperidol overencapsulated tablet taken orally once a day
1260481|NCT00044044|O3|Outcome|80 mg|Lurasidone 80 mg oral tablet taken once a day
1260482|NCT00044044|O2|Outcome|40 mg|Lurasidone 40 mg oral tablet taken once a day
1260483|NCT00044044|O1|Outcome|20 mg|Lurasidone 20 mg oral tablet taken once a day
1260484|NCT00044044|O5|Outcome|Placebo|Oral Capsule matching treatment group taken oce a day
1260485|NCT00044044|O4|Outcome|10 mg Haloperidol|10 mg Haloperidol overencapsulated tablet taken orally once a day
1260486|NCT00044044|O3|Outcome|80 mg|Lurasidone 80 mg oral tablet taken once a day
1260487|NCT00044044|O2|Outcome|40 mg|Lurasidone 40 mg oral tablet taken once a day
1260488|NCT00044044|O1|Outcome|20 mg|Lurasidone 20 mg oral tablet taken once a day
1260489|NCT00044044|O5|Outcome|Placebo|Oral Capsule matching treatment group taken oce a day
1260490|NCT00044044|O4|Outcome|10 mg Haloperidol|10 mg Haloperidol overencapsulated tablet taken orally once a day
1260491|NCT00044044|O3|Outcome|80 mg|Lurasidone 80 mg oral tablet taken once a day
1260492|NCT00044044|O2|Outcome|40 mg|Lurasidone 40 mg oral tablet taken once a day
1260493|NCT00044044|O1|Outcome|20 mg|Lurasidone 20 mg oral tablet taken once a day
1260494|NCT00044044|O5|Outcome|Placebo|Oral Capsule matching treatment group taken oce a day
1260495|NCT00044044|O4|Outcome|10 mg Haloperidol|10 mg Haloperidol overencapsulated tablet taken orally once a day
1260496|NCT00044044|O3|Outcome|80 mg|Lurasidone 80 mg oral tablet taken once a day
1260497|NCT00044044|O2|Outcome|40 mg|Lurasidone 40 mg oral tablet taken once a day
1260498|NCT00044044|O1|Outcome|20 mg|Lurasidone 20 mg oral tablet taken once a day
1260499|NCT00044044|E5|Reported Event|Placebo|Oral Capsule matching treatment group taken oce a day
1260500|NCT00044044|E4|Reported Event|10 mg Haloperidol|10 mg Haloperidol overencapsulated tablet taken orally once a day
1260501|NCT00044044|E3|Reported Event|80 mg|Lurasidone 80 mg oral tablet taken once a day
1260502|NCT00044044|E2|Reported Event|40 mg|Lurasidone 40 mg oral tablet taken once a day
1260503|NCT00044044|E1|Reported Event|20 mg|Lurasidone 20 mg oral tablet taken once a day
1260504|NCT00044005|B4|Baseline|Total|Total of all reporting groups
1260505|NCT00044005|B3|Baseline|Lurasidone 80mg|Lurasidone 80mg oral tablets
1260506|NCT00044005|B2|Baseline|Lurasidone 40 mg|Lurasidone 40 mg oral tablets
1260507|NCT00044005|B1|Baseline|Lurasidone 20 mg|Lurasdione 20 mg oral tablets
1260508|NCT00044005|P3|Participant Flow|Lurasidone 80mg|Lurasidone 80mg oral tablets
1260509|NCT00044005|P2|Participant Flow|Lurasidone 40 mg|Lurasidone 40 mg oral tablets
1260510|NCT00044005|P1|Participant Flow|Lurasidone 20 mg|Lurasdione 20 mg oral tablets
1260511|NCT00044005|O3|Outcome|Lurasidone 80mg|Lurasidone 80mg oral tablets
1260512|NCT00044005|O2|Outcome|Lurasidone 40 mg|Lurasidone 40 mg oral tablets
1260513|NCT00044005|O1|Outcome|Lurasidone 20 mg|Lurasdione 20 mg oral tablets
1260514|NCT00044005|E3|Reported Event|Lurasidone 80mg|Lurasidone 80mg oral tablets
1260515|NCT00044005|E2|Reported Event|Lurasidone 40 mg|Lurasidone 40 mg oral tablets
1260516|NCT00044005|E1|Reported Event|Lurasidone 20 mg|Lurasdione 20 mg oral tablets
1260517|NCT00043979|B3|Baseline|Total|Total of all reporting groups
1260518|NCT00043979|B2|Baseline|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
1260519|NCT00043979|B1|Baseline|Arm 1-Sibling Donors|Donors (n=30) were matched first degree relatives who were eligible to donate peripheral blood stem cells.
1260520|NCT00043979|P3|Participant Flow|Recipients Tacrolimus /Sirolimus Prophylaxis|"In period 1 recipients received EPOCH-F/chemotherapy. In period 2 recipients received peripheral blood stem transplant.~Post transplant recipients received tacrolimus & sirolimus for GVHD prophylaxis."
1260521|NCT00043979|P2|Participant Flow|Recipients Cyclosporine GVHD Prophylaxis|"In period 1 recipients received EPOCH-F/chemotherapy. In period 2 recipients received peripheral blood stem transplant.~Post transplant recipients received cyclosporine for GVHD prophylaxis."
1260522|NCT00043979|P1|Participant Flow|Sibling Donors|Donors (n = 30) were matched first degree relatives who were eligible to donate peripheral blood stem cells.In period 1 they donated cells.
1260523|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
1260524|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
1260525|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
1260526|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
1260527|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
1260616|NCT00041756|B2|Baseline|25 mg PG-530742|25 mg PG-530742 dosed BID
1260528|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
1260529|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
1260530|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
1260531|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
1260532|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
1260533|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
1260534|NCT00043979|O2|Outcome|Recipients -Tacrolimus/Sirolimus GVHD Prophylaxis|
1260535|NCT00043979|O1|Outcome|Recipients -Cyclosporine GVHD Prophylaxis|
1260536|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
1260537|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
1260538|NCT00043979|E1|Reported Event|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
1260539|NCT00043550|B4|Baseline|Total|Total of all reporting groups
1260540|NCT00043550|B3|Baseline|3 Pill Placebo|"Participants receive placebo.~Pill Placebo : Participants will receive a pill placebo."
1260541|NCT00043550|B2|Baseline|2 Supportive-expressive Psychotherapy|"Participants will receive supportive-expressive psychotherapy.~Supportive Expressive Therapy : The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship."
1260542|NCT00043550|B1|Baseline|1 Sertraline|"Participants receive sertraline.~Sertraline : Participants will receive sertraline."
1260543|NCT00043550|P3|Participant Flow|3 Pill Placebo|"Participants receive placebo.~Pill Placebo : Participants will receive a pill placebo."
1260544|NCT00043550|P2|Participant Flow|2 Supportive-expressive Psychotherapy|"Participants will receive supportive-expressive psychotherapy.~Supportive Expressive Therapy : The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship."
1260545|NCT00043550|P1|Participant Flow|1 Sertraline|"Participants receive sertraline.~Sertraline : Participants will receive sertraline."
1260546|NCT00043550|O3|Outcome|3 Pill Placebo|"Participants receive placebo.~Pill Placebo : Participants will receive a pill placebo."
1260547|NCT00043550|O2|Outcome|2 Supportive-expressive Psychotherapy|"Participants will receive supportive-expressive psychotherapy.~Supportive Expressive Therapy : The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship."
1260548|NCT00043550|O1|Outcome|1 Sertraline|"Participants receive sertraline.~Sertraline : Participants will receive sertraline."
1260549|NCT00043550|E3|Reported Event|3 Pill Placebo|"Participants receive placebo.~Pill Placebo : Participants will receive a pill placebo."
1260550|NCT00043550|E2|Reported Event|2 Supportive-expressive Psychotherapy|"Participants will receive supportive-expressive psychotherapy.~Supportive Expressive Therapy : The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship."
1260551|NCT00043550|E1|Reported Event|1 Sertraline|"Participants receive sertraline.~Sertraline : Participants will receive sertraline."
1260552|NCT00042432|B3|Baseline|Total|Total of all reporting groups
1260553|NCT00042432|B2|Baseline|Placebo|Placebo administered orally once daily
1260554|NCT00042432|B1|Baseline|Cinacalcet (AMG 073)|Cinacalcet administered orally once daily with dose titrated starting at 30 mg
1260555|NCT00042432|P2|Participant Flow|Placebo|Placebo administered orally once daily
1260556|NCT00042432|P1|Participant Flow|Cinacalcet (AMG 073)|Cinacalcet administered orally once daily with dose titrated starting at 30 mg
1260557|NCT00042432|O2|Outcome|Placebo|Placebo administered orally once daily
1260558|NCT00042432|O1|Outcome|Cinacalcet (AMG 073)|Cinacalcet administered orally once daily with dose titrated starting at 30 mg
1260559|NCT00042432|O2|Outcome|Placebo|Placebo administered orally once daily
1260560|NCT00042432|O1|Outcome|Cinacalcet (AMG 073)|Cinacalcet administered orally once daily with dose titrated starting at 30 mg
1260561|NCT00042432|E2|Reported Event|Cinacalcet|
1260562|NCT00042432|E1|Reported Event|Placebo|
1260563|NCT00040365|B1|Baseline|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
1260564|NCT00040365|P1|Participant Flow|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
1260565|NCT00040365|O1|Outcome|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
1260617|NCT00041756|B1|Baseline|Placebo Tablet|Placebo tablet dosed BID
1260618|NCT00041756|P5|Participant Flow|200 mg PG-530742|200 mg PG-530742 dosed BID
1260566|NCT00040365|O1|Outcome|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
1260567|NCT00040365|O1|Outcome|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
1260568|NCT00040365|O1|Outcome|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
1260569|NCT00040365|O1|Outcome|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
1260570|NCT00040365|O1|Outcome|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
1260571|NCT00040365|E1|Reported Event|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
1260572|NCT00042224|B3|Baseline|Total|Total of all reporting groups
1260573|NCT00042224|B2|Baseline|Medication Monotherapy|"Drug: Clozapine Patients with psychotic symptoms will receive clozapine~Other Names:~• Clozaril"
1260574|NCT00042224|B1|Baseline|Electroconvulsive Therapy With Medication|"Procedure/Surgery: Electroconvulsive Therapy (ECT) ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.~Drug: Clozapine Patients with psychotic symptoms will receive clozapine~Other Names:~• Clozaril"
1260575|NCT00042224|P2|Participant Flow|2 Medication Monotherapy|Clozapine: Patients with psychotic symptoms will receive clozapine
1260576|NCT00042224|P1|Participant Flow|1 Electroconvulsive Therapy With Medication|"Electroconvulsive Therapy (ECT): ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.~Clozapine: Patients with psychotic symptoms will receive clozapine"
1260577|NCT00042224|O2|Outcome|Medication Monotherapy|"Drug: Clozapine Patients with psychotic symptoms will receive clozapine~Other Names:~• Clozaril"
1260578|NCT00042224|O1|Outcome|Electroconvulsive Therapy With Medication|"Procedure/Surgery: Electroconvulsive Therapy (ECT) ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.~Drug: Clozapine Patients with psychotic symptoms will receive clozapine~Other Names:~• Clozaril"
1260579|NCT00042224|E2|Reported Event|Medication Monotherapy|"Drug: Clozapine Patients with psychotic symptoms will receive clozapine~Other Names:~• Clozaril"
1260580|NCT00042224|E1|Reported Event|Electroconvulsive Therapy With Medication|"Procedure/Surgery: Electroconvulsive Therapy (ECT) ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.~Drug: Clozapine Patients with psychotic symptoms will receive clozapine~Other Names:~• Clozaril"
1260581|NCT00041938|B3|Baseline|Total|Total of all reporting groups
1260582|NCT00041938|B2|Baseline|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
1260583|NCT00041938|B1|Baseline|Aspirin|Aspirin : 325 mg per day
1260584|NCT00041938|P2|Participant Flow|Warfarin|Warfarin : International Normalized Ratio (INR) 2.5-3.0; target INR 2.75
1260585|NCT00041938|P1|Participant Flow|Aspirin|Aspirin : 325 mg per day
1260586|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
1260587|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
1260588|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
1260589|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
1260590|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
1260591|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
1260592|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
1260593|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
1260594|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
1260595|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
1260596|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
1260597|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
1260598|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
1260599|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
1260600|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
1260601|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
1260602|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
1260603|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
1260604|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
1260605|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
1260606|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
1260607|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
1260608|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
1260609|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
1260610|NCT00041938|E2|Reported Event|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
1260611|NCT00041938|E1|Reported Event|Aspirin|Aspirin : 325 mg per day
1260612|NCT00041756|B6|Baseline|Total|Total of all reporting groups
1260613|NCT00041756|B5|Baseline|200 mg PG-530742|200 mg PG-530742 dosed BID
1260614|NCT00041756|B4|Baseline|100 mg PG-530742|100 mg PG-530742 dosed BID
1260615|NCT00041756|B3|Baseline|50 mg PG-530742|50 mg PG-530742 dosed BID
1260636|NCT00041756|E2|Reported Event|25 mg PG-530742|25 mg PG-530742 dosed BID
1260637|NCT00041756|E1|Reported Event|Placebo Tablet|Placebo tablet dosed BID
1260638|NCT00041717|B3|Baseline|Total|Total of all reporting groups
1260639|NCT00041717|B2|Baseline|Placebo|Placebo : Placebo
1260640|NCT00041717|B1|Baseline|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
1260641|NCT00041717|P2|Participant Flow|Placebo|Placebo : Placebo
1260642|NCT00041717|P1|Participant Flow|Fampridine-SR 50mg/Day|Fampridine-sustained release (SR) : 25mg bid (twice daily)
1260643|NCT00041717|O2|Outcome|Placebo|Placebo : Placebo
1260644|NCT00041717|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
1260645|NCT00041717|O2|Outcome|Placebo|Placebo : Placebo
1260646|NCT00041717|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
1260647|NCT00041717|E2|Reported Event|Placebo|Placebo : Placebo
1260648|NCT00041717|E1|Reported Event|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
1260649|NCT00039871|B1|Baseline|PegIntron Plus Rebetol|
1260650|NCT00039871|P1|Participant Flow|PegIntron Plus Rebetol|
1260651|NCT00039871|O1|Outcome|PegIntron Plus Rebetol|
1260652|NCT00039871|O1|Outcome|PegIntron Plus Rebetol|
1260653|NCT00039871|O1|Outcome|PegIntron Plus Rebetol|
1260654|NCT00039871|E1|Reported Event|PegIntron Plus Rebetol|
1260655|NCT00041470|B1|Baseline|Phase I/II|"Weekly paclitaxel (50 mg/m2 IV) and weekly vinorelbine (20 mg/m2 IV) with daily G-CSF support and Herceptin for patients with HER-2/neu positive disease. Treatment continues until disease progression, toxicity or other reason to remove the patient from protocol treatment.~Paclitaxel is administered weekly. Dose levels:~50 mg/m2, 60 mg/m2, 70 mg/m2, 80 mg/m2~Vinorelbine (Navelbine) is administered one hour after paclitaxel, every week. Dose levels:~20 mg/m2, 22.5 mg/m2, 25 mg/m2, 27.5 mg/m2~Patients whose tumors over express HER-2-neu and who meet the cardiac safety criteria will receive weekly Herceptin administered by intravenous infusion.~Herceptin 4 mg/kg IV given only on day 1 of the first cycle. Herceptin 2 mg/kg IV, maintenance dose will be given every week starting with week 2.~G-CSF (filgrastim, Neupogen) 5 mg/kg/day s.c., is administered daily including the day of chemotherapy.~Paclitaxel: 50 mg/m2 IV weekly. Treatment continues until disease pr"
1260656|NCT00041470|P1|Participant Flow|Paclitaxel, Vinorelbine, G-CSF, Herceptin - no Placebo|"Weekly paclitaxel (50 mg/m2 IV) and weekly vinorelbine (20 mg/m2 IV) with daily G-CSF support and Herceptin for patients with HER-2/neu positive disease. Treatment continues until disease progression, toxicity or other reason to remove the patient from protocol treatment.~Paclitaxel is administered weekly. Dose levels:~50 mg/m2, 60 mg/m2, 70 mg/m2, 80 mg/m2~Vinorelbine (Navelbine) is administered one hour after paclitaxel, every week. Dose levels:~20 mg/m2, 22.5 mg/m2, 25 mg/m2, 27.5 mg/m2~Patients whose tumors over express HER-2-neu and who meet the cardiac safety criteria will receive weekly Herceptin administered by intravenous infusion.~Herceptin 4 mg/kg IV given only on day 1 of the first cycle. Herceptin 2 mg/kg IV, maintenance dose will be given every week starting with week 2.~G-CSF (filgrastim, Neupogen) 5 mg/kg/day s.c., is administered daily including the day of chemotherapy.~Paclitaxel: 50 mg/m2 IV weekly. Treatment continues until progression"
1260657|NCT00041470|O1|Outcome|Weekly Paclitaxel, Vinorelbine and GCSF|"Weekly paclitaxel (50 mg/m2 IV) and weekly vinorelbine (20 mg/m2 IV) with daily G-CSF support and Herceptin for patients with HER-2/neu positive disease.~Paclitaxel weekly. Dose levels:~50 mg/m2, 60 mg/m2, 70 mg/m2, 80 mg/m2~Vinorelbine (Navelbine) administered one hour after paclitaxel, weekly. Dose levels:~20 mg/m2, 22.5 mg/m2, 25 mg/m2, 27.5 mg/m2~Patients who are HER-2+ and IV infusion. Herceptin 4 mg/kg IV given only on day 1 of the first cycle. Herceptin 2 mg/kg IV, maintenance dose will be given every week starting with week 2.~G-CSF (filgrastim, Neupogen) 5 mg/kg/day s.c., administered daily~Paclitaxel: 50 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.~Vinorelbine: 20 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.~Herceptin: 4 mg/kg IV loading dose day 1"
1260658|NCT00041470|O1|Outcome|Weekly Paclitaxel, Vinorelbine and GCSF|"Weekly paclitaxel (50 mg/m2 IV) and weekly vinorelbine (20 mg/m2 IV) with daily G-CSF support and Herceptin for patients with HER-2/neu positive disease.~Paclitaxel weekly. Dose levels:~50 mg/m2, 60 mg/m2, 70 mg/m2, 80 mg/m2~Vinorelbine (Navelbine) administered one hour after paclitaxel, weekly. Dose levels:~20 mg/m2, 22.5 mg/m2, 25 mg/m2, 27.5 mg/m2~Patients who are HER-2+ and IV infusion. Herceptin 4 mg/kg IV given only on day 1 of the first cycle. Herceptin 2 mg/kg IV, maintenance dose will be given every week starting with week 2.~G-CSF (filgrastim, Neupogen) 5 mg/kg/day s.c., administered daily~Paclitaxel: 50 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.~Vinorelbine: 20 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.~Herceptin: 4 mg/kg IV loading dose day 1"
1260659|NCT00041470|E1|Reported Event|Weekly Paclitaxel and Vinorelbine With GCSF Support|"Weekly paclitaxel (50 mg/m2 IV) and vinorelbine (20 mg/m2 IV) with daily G-CSF and Herceptin for patients with HER-2+ disease. Treatment until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.~Paclitaxel administered weekly. Dose levels:~50 mg/m2, 60 mg/m2, 70 mg/m2, 80 mg/m2~Vinorelbine (Navelbine) administered one hour after paclitaxel, weekly. Dose levels:~20 mg/m2, 22.5 mg/m2, 25 mg/m2, 27.5 mg/m2~Patients who are HER-2+ and meet the cardiac safety criteria will receive weekly Herceptin administered by infusion.~Herceptin 4 mg/kg IV given only on day 1 of the first cycle. Herceptin 2 mg/kg IV, maintenance dose will be given every week starting with week 2.~G-CSF (filgrastim, Neupogen) 5 mg/kg/day s.c., is administered daily including the day of chemotherapy.~Paclitaxel: 50 mg/m2 IV weekly. Treatment continues until disease pr"
1260660|NCT00041392|B3|Baseline|Total|Total of all reporting groups
1260661|NCT00041392|B2|Baseline|0.9 % Saline|100 mg/kg 0.9 % saline
1260662|NCT00041392|B1|Baseline|Magnesium|100 mg/kg magnesium
1260663|NCT00041392|P2|Participant Flow|0.9 % Saline|100 mg/kg 0.9 % saline
1260664|NCT00041392|P1|Participant Flow|Magnesium|100 mg/kg magnesium
1260665|NCT00041392|O2|Outcome|0.9 % Saline|100 mg/kg 0.9 % saline
1260692|NCT00041119|O2|Outcome|Paclitaxel|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 4 or 6 courses in the absence of disease progression or unacceptable toxicity.
1261437|NCT00031486|O1|Outcome|Valacyclovir|four 500 mg tablets 3 times a day for 90 days
1260669|NCT00041132|B1|Baseline|Hyper-CVAD + MTX/Ara-C + Rituximab|"21-day cycles of Hyper-CVAD and high-dose methotrexate/Ara-C are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6.~Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m^2 on day 1, mesna 600 mg/m^2 on days 2-4, cyclophosphamide 300 mg/m^2 on days 2-4, doxorubicin 16.6 mg/m^2/day on days 5-7, vincristine 1.4 mg/m^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and G-CSF 5 ug/kg on days 8-21.~Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m^2 on day 1, methotrexate 1000 mg/m^2 over days 2-3, Ara-C 12 g/m^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21."
1260670|NCT00041132|P1|Participant Flow|Hyper-CVAD + MTX/Ara-C + Rituximab|"21-day cycles of Hyper-CVAD and high-dose methotrexate/Ara-C are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6.~Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m^2 on day 1, mesna 600 mg/m^2 on days 2-4, cyclophosphamide 300 mg/m^2 on days 2-4, doxorubicin 16.6 mg/m^2/day on days 5-7, vincristine 1.4 mg/m^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and G-CSF 5 ug/kg on days 8-21.~Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m^2 on day 1, methotrexate 1000 mg/m^2 over days 2-3, Ara-C 12 g/m^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21."
1260671|NCT00041132|O1|Outcome|Hyper-CVAD + MTX/Ara-C + Rituximab|"21-day cycles of Hyper-CVAD and high-dose methotrexate/Ara-C are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6.~Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m^2 on day 1, mesna 600 mg/m^2 on days 2-4, cyclophosphamide 300 mg/m^2 on days 2-4, doxorubicin 16.6 mg/m^2/day on days 5-7, vincristine 1.4 mg/m^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and G-CSF 5 ug/kg on days 8-21.~Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m^2 on day 1, methotrexate 1000 mg/m^2 over days 2-3, Ara-C 12 g/m^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21."
1260672|NCT00041132|O1|Outcome|Hyper-CVAD + MTX/Ara-C + Rituximab|"21-day cycles of Hyper-CVAD and high-dose methotrexate/Ara-C are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6.~Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m^2 on day 1, mesna 600 mg/m^2 on days 2-4, cyclophosphamide 300 mg/m^2 on days 2-4, doxorubicin 16.6 mg/m^2/day on days 5-7, vincristine 1.4 mg/m^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and G-CSF 5 ug/kg on days 8-21.~Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m^2 on day 1, methotrexate 1000 mg/m^2 over days 2-3, Ara-C 12 g/m^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21."
1260673|NCT00041132|O1|Outcome|Hyper-CVAD + MTX/Ara-C + Rituximab|"21-day cycles of Hyper-CVAD and high-dose methotrexate/Ara-C are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6.~Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m^2 on day 1, mesna 600 mg/m^2 on days 2-4, cyclophosphamide 300 mg/m^2 on days 2-4, doxorubicin 16.6 mg/m^2/day on days 5-7, vincristine 1.4 mg/m^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and G-CSF 5 ug/kg on days 8-21.~Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m^2 on day 1, methotrexate 1000 mg/m^2 over days 2-3, Ara-C 12 g/m^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21."
1260674|NCT00041132|E1|Reported Event|Hyper-CVAD + MTX/Ara-C + Rituximab|
1260675|NCT00041119|B5|Baseline|Total|Total of all reporting groups
1260676|NCT00041119|B4|Baseline|Arm IV (Paclitaxel for 6 Courses [Closed 12/15/2007])|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
1260677|NCT00041119|B3|Baseline|Arm III (Paclitaxel for 4 Courses)|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
1260678|NCT00041119|B2|Baseline|Arm II (CA for 6 Courses [Closed to Accrual 12/15/2007])|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
1260679|NCT00041119|B1|Baseline|Arm I (CA for 4 Courses)|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
1260680|NCT00041119|P4|Participant Flow|Arm IV (Paclitaxel for 6 Courses [Closed 12/15/2007])|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
1260681|NCT00041119|P3|Participant Flow|Arm III (Paclitaxel for 4 Courses)|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
1260682|NCT00041119|P2|Participant Flow|Arm II (CA for 6 Courses [Closed to Accrual 12/15/2007])|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
1260683|NCT00041119|P1|Participant Flow|Arm I (CA for 4 Courses)|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
1260684|NCT00041119|O2|Outcome|4 Cycles|Patients will either receive cyclophosphamide and doxorubicin hydrochloride for 4 cycles or Paclitaxel for 4 cycles
1260685|NCT00041119|O1|Outcome|6 Cycles|Patients will either receive cyclophosphamide and doxorubicin hydrochloride for 6 cycles or Paclitaxel for 6 cycles
1260686|NCT00041119|O2|Outcome|Paclitaxel|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 4 or 6 courses in the absence of disease progression or unacceptable toxicity.
1260687|NCT00041119|O1|Outcome|Cyclophosphamide and Doxorubicin Hydrochloride|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 4 or 6 courses in the absence of disease progression or unacceptable toxicity.
1260688|NCT00041119|O2|Outcome|Paclitaxel|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 4 or 6 courses in the absence of disease progression or unacceptable toxicity.
1260689|NCT00041119|O1|Outcome|Cyclophosphamide and Doxorubicin Hydrochloride|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 4 or 6 courses in the absence of disease progression or unacceptable toxicity.
1260690|NCT00041119|O2|Outcome|4 Cycles|Patients will either receive cyclophosphamide and doxorubicin hydrochloride for 4 cycles or Paclitaxel for 4 cycles
1260691|NCT00041119|O1|Outcome|6 Cycles|Patients will either receive cyclophosphamide and doxorubicin hydrochloride for 6 cycles or Paclitaxel for 6 cycles
1260693|NCT00041119|O1|Outcome|Cyclophosphamide and Doxorubicin Hydrochloride|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 4 or 6 courses in the absence of disease progression or unacceptable toxicity.
1260694|NCT00041119|O2|Outcome|Arm VI (Arm III and Arm IV) Combined|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
1260695|NCT00041119|O1|Outcome|Arm V (Arm I and Arm II Combined)|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 4 or 6 courses in the absence of disease progression or unacceptable toxicity.
1260696|NCT00041119|O2|Outcome|6 Cycles (Arm II and Arm IV Combined)|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV OR paclitaxel over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
1260697|NCT00041119|O1|Outcome|4 Cycles (Arm I and Arm III Combined)|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV OR paclitaxel over 3 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
1260698|NCT00041119|E4|Reported Event|Arm IV (Paclitaxel for 6 Courses [Closed 12/15/2007])|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
1260699|NCT00041119|E3|Reported Event|Arm III (Paclitaxel for 4 Courses)|Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
1260700|NCT00041119|E2|Reported Event|Arm II (CA for 6 Courses [Closed to Accrual 12/15/2007])|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
1260701|NCT00041119|E1|Reported Event|Arm I (CA for 4 Courses)|Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
1260702|NCT00041080|B3|Baseline|Total|Total of all reporting groups
1260703|NCT00041080|B2|Baseline|Grp - 2|Tamoxifen 20mg orally for up to 12 28-day cycles until progression or adverse effect prohibited additional therapy.
1260704|NCT00041080|B1|Baseline|Grp - 1|Thalidomide 200mg orally daily with weekly escalation of 100mg to a maximum dose of 400mg until progression or additional therapy prohibited further therapy.
1260705|NCT00041080|P2|Participant Flow|Grp - 2|Tamoxifen 20mg orally twice daily for up to 12 28-day cycles until progression or adverse effect prohibited additional therapy.
1260706|NCT00041080|P1|Participant Flow|Grp - 1|Thalidomide 200mg orally daily with weekly escalation of 100mg to a maximum dose of 400mg until progression or additional therapy prohibited further therapy.
1260707|NCT00041080|O2|Outcome|Grp - 2|Tamoxifen 20mg orally for up to 12 28-day cycles until progression or adverse effect prohibited additional therapy.
1260708|NCT00041080|O1|Outcome|Grp - 1|Thalidomide 200mg orally daily with weekly escalation of 100mg to a maximum dose of 400mg until progression or additional therapy prohibited further therapy.
1260709|NCT00041080|E2|Reported Event|Grp - 2|Tamoxifen 20mg orally for up to 12 28-day cycles until progression or adverse effect prohibited additional therapy.
1260710|NCT00041080|E1|Reported Event|Grp - 1|Thalidomide 200mg orally daily with weekly escalation of 100mg to a maximum dose of 400mg until progression or additional therapy prohibited further therapy.
1260711|NCT00041067|B1|Baseline|Trastuzumab, Docetaxel, Vinorelbine and Filgrastim|"Trastuzumab, docetaxel, vinorelbine and filgrastim~docetaxel : 60 mg/m^2 on Day 1 of 21-day cycles~vinorelbine : 27.5 mg/m^2 on Days 8 and 15~filgrastim : 5 microg/kg/day on Days 2 to 21~trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period"
1260712|NCT00041067|P1|Participant Flow|Trastuzumab, Docetaxel, Vinorelbine and Filgrastim|"Trastuzumab, docetaxel, vinorelbine and filgrastim~docetaxel : 60 mg/m^2 on Day 1 of 21-day cycles~vinorelbine : 27.5 mg/m^2 on Days 8 and 15~filgrastim : 5 microg/kg/day on Days 2 to 21~trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period"
1260713|NCT00041067|O1|Outcome|Docetaxel + Vinorelbine + G-CSF + Trastuzumab|
1260714|NCT00041067|O1|Outcome|Trastuzumab, Docetaxel, Vinorelbine and Filgrastim|"Trastuzumab, docetaxel, vinorelbine and filgrastim~docetaxel : 60 mg/m^2 on Day 1 of 21-day cycles~vinorelbine : 27.5 mg/m^2 on Days 8 and 15~filgrastim : 5 microg/kg/day on Days 2 to 21~trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period"
1260715|NCT00041067|O1|Outcome|Trastuzumab, Docetaxel, Vinorelbine and Filgrastim|"Trastuzumab, docetaxel, vinorelbine and filgrastim~docetaxel : 60 mg/m^2 on Day 1 of 21-day cycles~vinorelbine : 27.5 mg/m^2 on Days 8 and 15~filgrastim : 5 microg/kg/day on Days 2 to 21~trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period"
1260716|NCT00041067|O1|Outcome|Trastuzumab, Docetaxel, Vinorelbine and Filgrastim|"Trastuzumab, docetaxel, vinorelbine and filgrastim~docetaxel : 60 mg/m^2 on Day 1 of 21-day cycles~vinorelbine : 27.5 mg/m^2 on Days 8 and 15~filgrastim : 5 microg/kg/day on Days 2 to 21~trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period"
1260717|NCT00041067|E1|Reported Event|Docetaxel + Vinorelbine + G-CSF + Trastuzumab|
1260718|NCT00040937|B1|Baseline|Treatment Arm|thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance
1260719|NCT00040937|P1|Participant Flow|Treatment Arm|thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance
1260720|NCT00040937|O1|Outcome|Treatment Arm|thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance
1260721|NCT00040937|O1|Outcome|Induction/PBSC Mobilization|
1260722|NCT00040937|E3|Reported Event|Prednisone + Thalidomide|
1260723|NCT00040937|E2|Reported Event|Autologous PBSCT|
1260816|NCT00040664|O1|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years
1261438|NCT00031486|O3|Outcome|Total|
1260726|NCT00040846|B6|Baseline|Dose Level 6 (0.40 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260727|NCT00040846|B5|Baseline|Dose Level 5 (0.20 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260728|NCT00040846|B4|Baseline|Dose Level 4 (0.10 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260729|NCT00040846|B3|Baseline|Dose Level 3 (0.050 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260730|NCT00040846|B2|Baseline|Dose Level 2 (0.025 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260731|NCT00040846|B1|Baseline|Dose Level 1 (No Campath)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO"
1260732|NCT00040846|P6|Participant Flow|Dose Level 6 (0.40 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260733|NCT00040846|P5|Participant Flow|Dose Level 5 (0.20 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260734|NCT00040846|P4|Participant Flow|Dose Level 4 (0.10 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260799|NCT00040664|P1|Participant Flow|Overall Fosamprenavir (FPV)/Ritonavir(RTV)|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)
1260800|NCT00040664|O4|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years
1260801|NCT00040664|O3|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years
1260735|NCT00040846|P3|Participant Flow|Dose Level 3 (0.050 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260736|NCT00040846|P2|Participant Flow|Dose Level 2 (0.025 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260737|NCT00040846|P1|Participant Flow|Dose Level 1 (No Campath)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO"
1260738|NCT00040846|O6|Outcome|Dose Level 6 (0.40 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260739|NCT00040846|O5|Outcome|Dose Level 5 (0.20 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260740|NCT00040846|O4|Outcome|Dose Level 4 (0.10 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260741|NCT00040846|O3|Outcome|Dose Level 3 (0.050 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260742|NCT00040846|O2|Outcome|Dose Level 2 (0.025 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260743|NCT00040846|O1|Outcome|Dose Level 1 (No Campath)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO"
1260802|NCT00040664|O2|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years
1260803|NCT00040664|O1|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years
1260804|NCT00040664|O4|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years vs. Historical Adult Data
1260815|NCT00040664|O1|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years
1260744|NCT00040846|O6|Outcome|Dose Level 6 (0.40 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260745|NCT00040846|O5|Outcome|Dose Level 5 (0.20 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260746|NCT00040846|O4|Outcome|Dose Level 4 (0.10 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260747|NCT00040846|O3|Outcome|Dose Level 3 (0.050 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260748|NCT00040846|O2|Outcome|Dose Level 2 (0.025 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260749|NCT00040846|O1|Outcome|Dose Level 1 (No Campath)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO"
1260750|NCT00040846|O6|Outcome|Dose Level 6 (0.40 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260751|NCT00040846|O5|Outcome|Dose Level 5 (0.20 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260752|NCT00040846|O4|Outcome|Dose Level 4 (0.10 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260805|NCT00040664|O3|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years vs. Historical Adult Data
1260806|NCT00040664|O2|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years vs. Historical Adult Data
1260807|NCT00040664|O1|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years vs. Historical Adult Data
1260753|NCT00040846|O3|Outcome|Dose Level 3 (0.050 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260754|NCT00040846|O2|Outcome|Dose Level 2 (0.025 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260755|NCT00040846|O1|Outcome|Dose Level 1 (No Campath)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO"
1260756|NCT00040846|O6|Outcome|Dose Level 6 (0.40 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260757|NCT00040846|O5|Outcome|Dose Level 5 (0.20 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260758|NCT00040846|O4|Outcome|Dose Level 4 (0.10 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260759|NCT00040846|O3|Outcome|Dose Level 3 (0.050 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260760|NCT00040846|O2|Outcome|Dose Level 2 (0.025 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260761|NCT00040846|O1|Outcome|Dose Level 1 (No Campath)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO"
1260808|NCT00040664|O4|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years vs. Historical Adult Data
1260809|NCT00040664|O3|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years vs. Historical Adult Data
1260810|NCT00040664|O2|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years vs. Historical Adult Data
1261434|NCT00031486|O1|Outcome|Valacyclovir|four 500 mg tablets 3 times a day for 90 days
1260762|NCT00040846|O6|Outcome|Dose Level 6 (0.40 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260763|NCT00040846|O5|Outcome|Dose Level 5 (0.20 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260764|NCT00040846|O4|Outcome|Dose Level 4 (0.10 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260765|NCT00040846|O3|Outcome|Dose Level 3 (0.050 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260766|NCT00040846|O2|Outcome|Dose Level 2 (0.025 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260767|NCT00040846|O1|Outcome|Dose Level 1 (No Campath)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO"
1260768|NCT00040846|E6|Reported Event|Dose Level 6 (0.40 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260769|NCT00040846|E5|Reported Event|Dose Level 5 (0.20 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260770|NCT00040846|E4|Reported Event|Dose Level 4 (0.10 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260811|NCT00040664|O1|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years vs. Historical Adult Data
1260812|NCT00040664|O4|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years
1260813|NCT00040664|O3|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years
1261435|NCT00031486|O3|Outcome|Total|
1260771|NCT00040846|E3|Reported Event|Dose Level 3 (0.050 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260772|NCT00040846|E2|Reported Event|Dose Level 2 (0.025 mg/kg/Day Campath)|"CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO~alemtuzumab: Given IV"
1260773|NCT00040846|E1|Reported Event|Dose Level 1 (No Campath)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.~HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.~IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.~fludarabine phosphate: Given IV~total-body irradiation: Undergo TBI~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT~peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation~mycophenolate mofetil: Given PO~cyclosporine: Given IV or PO"
1260774|NCT00040742|B5|Baseline|Total|Total of all reporting groups
1260775|NCT00040742|B4|Baseline|1.5g Ginger|"Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally"
1260776|NCT00040742|B3|Baseline|1.0g Ginger|"Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
1260777|NCT00040742|B2|Baseline|0.5g Ginger|"Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
1260778|NCT00040742|B1|Baseline|Placebo|"Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~placebo: Given orally"
1260779|NCT00040742|P4|Participant Flow|1.5g Ginger|"Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally"
1260780|NCT00040742|P3|Participant Flow|1.0g Ginger|"Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
1260781|NCT00040742|P2|Participant Flow|0.5g Ginger|"Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
1260782|NCT00040742|P1|Participant Flow|Placebo|"Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~placebo: Given orally"
1260783|NCT00040742|O4|Outcome|1.5g Ginger|"Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally"
1260784|NCT00040742|O3|Outcome|1.0g Ginger|"Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
1260785|NCT00040742|O2|Outcome|0.5g Ginger|"Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
1260786|NCT00040742|O1|Outcome|Placebo|"Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~placebo: Given orally"
1260787|NCT00040742|O4|Outcome|1.5g Ginger|"Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally"
1260788|NCT00040742|O3|Outcome|1.0g Ginger|"Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
1260789|NCT00040742|O2|Outcome|0.5g Ginger|"Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
1260790|NCT00040742|O1|Outcome|Placebo|"Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~placebo: Given orally"
1260791|NCT00040742|E4|Reported Event|1.5g Ginger|"Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally"
1260792|NCT00040742|E3|Reported Event|1.0g Ginger|"Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
1260793|NCT00040742|E2|Reported Event|0.5g Ginger|"Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
1260794|NCT00040742|E1|Reported Event|Placebo|"Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~placebo: Given orally"
1260795|NCT00040664|B1|Baseline|FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)
1260796|NCT00040664|P4|Participant Flow|12-18 Years FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD), 12-18 years
1260797|NCT00040664|P3|Participant Flow|6-11 Years FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD), 6-11 years
1260798|NCT00040664|P2|Participant Flow|2-5 Years FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD), 2-5 years
1260814|NCT00040664|O2|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years
1260817|NCT00040664|O4|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years vs. Historical Adult Data
1260818|NCT00040664|O3|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years vs. Historical Adult Data
1260819|NCT00040664|O2|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years vs. Historical Adult Data
1260820|NCT00040664|O1|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years vs. Historical Adult Data
1260821|NCT00040664|O4|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years
1260822|NCT00040664|O3|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years
1260823|NCT00040664|O2|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years
1260824|NCT00040664|O1|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years
1260825|NCT00040664|O2|Outcome|PI-Experienced|Participants treated with equal to or less than 3 PIs (any length of time)
1260826|NCT00040664|O1|Outcome|PI-Naive|Participants with equal to or less than 1 week of treatment with a PI
1260827|NCT00040664|O4|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years
1260828|NCT00040664|O3|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years
1260829|NCT00040664|O2|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years
1260830|NCT00040664|O1|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years
1260831|NCT00040664|O4|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years
1260832|NCT00040664|O3|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years
1260833|NCT00040664|O2|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years
1260834|NCT00040664|O1|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years
1260835|NCT00040664|O1|Outcome|FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)
1260836|NCT00040664|O2|Outcome|FPV Oral Suspension|Fosamprenavir 50 mg/mL oral suspension/ritonavir 80 mg/mL oral solution once daily
1260837|NCT00040664|O1|Outcome|FPV Tablet|Fosamprenavir 700 mg tablets/ritonavir 100 mg capsules once daily
1260838|NCT00040664|O2|Outcome|PI-Experienced|Participants treated with equal to or less than 3 PIs (any length of time)
1260839|NCT00040664|O1|Outcome|PI-Naive|Participants with equal to or less than 1 week of treatment with a PI
1260840|NCT00040664|O2|Outcome|PI-Experienced|Participants treated with equal to or less than 3 PIs (any length of time)
1260841|NCT00040664|O1|Outcome|PI-Naive|Participants with equal to or less than 1 week of treatment with a Protease Inhibitor (PI)
1260842|NCT00040664|O2|Outcome|PI-Experienced|Participants treated with equal to or less than 3 PIs (any length of time)
1260843|NCT00040664|O1|Outcome|PI-Naive|Participants with equal to or less than 1 week of treatment with a Protease Inhibitor (PI)
1260844|NCT00040664|O1|Outcome|FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)
1260845|NCT00040664|E1|Reported Event|FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)
1260846|NCT00039741|B5|Baseline|Total|Total of all reporting groups
1260847|NCT00039741|B4|Baseline|NNRTI/30K|2 NRTIs plus an NNRTI with a regimen change recommended when viral load reaches 30,000 copies/ml or higher
1260848|NCT00039741|B3|Baseline|PI/30K|Two NRTIs plus a PIwith a regimen change recommended when viral load is 30,000 copies/ml or higher
1260849|NCT00039741|B2|Baseline|NNRTI/1K|2 NRTIs plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) with a regimen change recommended when viral load reaches 1,000 copies/ml or higher
1260850|NCT00039741|B1|Baseline|PI/1K|Two nucleoside reverse transcriptase inhibitors (NRTI) plus a protease inhibitor (PI)with a regimen change recommended when viral load is 1000 copies/ml or higher
1260851|NCT00039741|P4|Participant Flow|NNRTI/30K|2 NRTIs plus an NNRTI with a regimen change recommended when viral load reaches 30,000 copies/ml or higher
1260852|NCT00039741|P3|Participant Flow|PI/30K|Two NRTIs plus a PIwith a regimen change recommended when viral load is 30,000 copies/ml or higher
1260853|NCT00039741|P2|Participant Flow|NNRTI/1K|2 NRTIs plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) with a regimen change recommended when viral load reaches 1,000 copies/ml or higher
1260854|NCT00039741|P1|Participant Flow|PI/1K|Two nucleoside reverse transcriptase inhibitors (NRTI) plus a protease inhibitor (PI)with a regimen change recommended when viral load is 1000 copies/ml or higher
1260855|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
1260856|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
1260857|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
1260858|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
1260859|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
1260860|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
1260861|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
1260862|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
1260863|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
1260864|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
1260865|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
1260866|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
1260867|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
1260868|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
1260869|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
1260870|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
1260871|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
1260872|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
1260873|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
1260874|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
1260875|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
1260876|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
1260877|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
1260878|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
1260879|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
1260880|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
1260881|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
1260882|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
1260883|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
1260884|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
1260885|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
1260886|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
1260887|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
1260888|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
1260889|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
1260890|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
1260891|NCT00039741|E4|Reported Event|NNRTI/30K|2 NRTIs plus an NNRTI with a regimen change recommended when viral load reaches 30,000 copies/ml or higher
1260892|NCT00039741|E3|Reported Event|PI/30K|Two NRTIs plus a PIwith a regimen change recommended when viral load is 30,000 copies/ml or higher
1260893|NCT00039741|E2|Reported Event|NNRTI/1K|2 NRTIs plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) with a regimen change recommended when viral load reaches 1,000 copies/ml or higher
1260894|NCT00039741|E1|Reported Event|PI/1K|Two nucleoside reverse transcriptase inhibitors (NRTI) plus a protease inhibitor (PI)with a regimen change recommended when viral load is 1000 copies/ml or higher
1260895|NCT00039377|B1|Baseline|Entire Cohort|All participants treatment on this study, see the Detailed Description for treatment information.
1260896|NCT00039377|P4|Participant Flow|Patients Who Did Not Undergo Transplant for Course V|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients who are not candidates for PBSCT receive etoposide IV over 4 hours and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC once or twice a day beginning on day 14 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
1260897|NCT00039377|P3|Participant Flow|Patients Without HLA-matched Sibling Donors in Course V|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients without an HLA-matched sibling donor receive etoposide IV continuously and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC beginning on day 14 and continuing until PBSC collection is complete. Patients receive imatinib mesylate PO twice daily beginning after completion of PBSC collection and continuing until 3 days before PBSCT. Patients then undergo TBI 2-3 times daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Patients undergo PBSCT on day 0. Patients receive G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
1260929|NCT00038948|O4|Outcome|CNI Continuation Strata >40.0 mL/Min|Continued calcineurin inhibitor immunosuppression therapy in renal transplant recipients.
1260930|NCT00038948|O3|Outcome|SRL Conversion Strata >40.0 mL/Min|Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy in renal transplant recipients.
1261497|NCT00030901|O2|Outcome|Placebo|Patients receive oral placebo once daily for 3 years
1261052|NCT00037830|O2|Outcome|Delayed-Start Group|Group that was randomized to receive placebo for 24 weeks
1260898|NCT00039377|P2|Participant Flow|Patients With HLA-matched Sibling Donor in Course 5|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients with an HLA-matched sibling donor undergo total body irradiation (TBI) 2-3 times daily on days -7 to -4. Patients receive etoposide IV over 4 hours on day -3. Patients then undergo PBSCT on day 0. Patients then receive graft-vs-host disease prophylaxis with tacrolimus IV continuously on days -1 to 56 (or IV continuously on days -1 to 14 and then PO or IV every 12 hours on days 15-56) followed by a taper. Patients also receive methotrexate IV on days 1, 3, and 6, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 4 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
1260899|NCT00039377|P1|Participant Flow|Entire Cohort|All participants treatment on this study, see the Detailed Description for treatment information.
1260900|NCT00039377|O2|Outcome|Patients Without HLA-matched Sibling Donors|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients without an HLA-matched sibling donor receive etoposide IV continuously and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC beginning on day 14 and continuing until PBSC collection is complete. Patients receive imatinib mesylate PO twice daily beginning after completion of PBSC collection and continuing until 3 days before PBSCT. Patients then undergo TBI 2-3 times daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Patients undergo PBSCT on day 0. Patients receive G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
1260901|NCT00039377|O1|Outcome|Patients With HLA-matched Sibling Donor|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients with an HLA-matched sibling donor undergo total body irradiation (TBI) 2-3 times daily on days -7 to -4. Patients receive etoposide IV over 4 hours on day -3. Patients then undergo PBSCT on day 0. Patients then receive graft-vs-host disease prophylaxis with tacrolimus IV continuously on days -1 to 56 (or IV continuously on days -1 to 14 and then PO or IV every 12 hours on days 15-56) followed by a taper. Patients also receive methotrexate IV on days 1, 3, and 6, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 4 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
1260902|NCT00039377|O2|Outcome|Patients Without HLA-matched Sibling Donors|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients without an HLA-matched sibling donor receive etoposide IV continuously and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC beginning on day 14 and continuing until PBSC collection is complete. Patients receive imatinib mesylate PO twice daily beginning after completion of PBSC collection and continuing until 3 days before PBSCT. Patients then undergo TBI 2-3 times daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Patients undergo PBSCT on day 0. Patients receive G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
1260903|NCT00039377|O1|Outcome|Patients With HLA-matched Sibling Donor|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients with an HLA-matched sibling donor undergo total body irradiation (TBI) 2-3 times daily on days -7 to -4. Patients receive etoposide IV over 4 hours on day -3. Patients then undergo PBSCT on day 0. Patients then receive graft-vs-host disease prophylaxis with tacrolimus IV continuously on days -1 to 56 (or IV continuously on days -1 to 14 and then PO or IV every 12 hours on days 15-56) followed by a taper. Patients also receive methotrexate IV on days 1, 3, and 6, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 4 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
1260904|NCT00039377|O1|Outcome|Entire Cohort|All participants treatment on this study, see the Detailed Description for treatment information.
1260905|NCT00039377|O1|Outcome|Entire Cohort|All participants treatment on this study, see the Detailed Description for treatment information.
1260906|NCT00039377|O1|Outcome|Entire Cohort|All participants treatment on this study, see the Detailed Description for treatment information.
1260907|NCT00039377|E3|Reported Event|Patients Who Did Not Undergo Transplant|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients who are not candidates for PBSCT receive etoposide IV over 4 hours and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC once or twice a day beginning on day 14 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
1260908|NCT00039377|E2|Reported Event|Patients Without HLA-matched Sibling Donors|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients without an HLA-matched sibling donor receive etoposide IV continuously and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC beginning on day 14 and continuing until PBSC collection is complete. Patients receive imatinib mesylate PO twice daily beginning after completion of PBSC collection and continuing until 3 days before PBSCT. Patients then undergo TBI 2-3 times daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Patients undergo PBSCT on day 0. Patients receive G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
1260909|NCT00039377|E1|Reported Event|Patients With HLA-matched Sibling Donor|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients with an HLA-matched sibling donor undergo total body irradiation (TBI) 2-3 times daily on days -7 to -4. Patients receive etoposide IV over 4 hours on day -3. Patients then undergo PBSCT on day 0. Patients then receive graft-vs-host disease prophylaxis with tacrolimus IV continuously on days -1 to 56 (or IV continuously on days -1 to 14 and then PO or IV every 12 hours on days 15-56) followed by a taper. Patients also receive methotrexate IV on days 1, 3, and 6, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 4 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
1260910|NCT00039195|B1|Baseline|Induction R-CHOPac Therapy|Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
1260911|NCT00039195|P1|Participant Flow|Induction R-CHOPac Therapy|Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
1260912|NCT00039195|O1|Outcome|Induction R-CHOPac Therapy|Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
1260913|NCT00039195|E1|Reported Event|Induction R-CHOPac Therapy|Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
1260914|NCT00039130|B1|Baseline|Rituximab With High Intensity Chemotherapy|"Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)~Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)~Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)"
1260915|NCT00039130|P1|Participant Flow|Rituximab With High Intensity Chemotherapy|"Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)~Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)~Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)"
1260916|NCT00039130|O1|Outcome|Rituximab With High Intensity Chemotherapy|"Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)~Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)~Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)"
1260917|NCT00039130|O1|Outcome|Rituximab With High Intensity Chemotherapy|"Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)~Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)~Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)"
1260918|NCT00039130|O1|Outcome|Rituximab With High Intensity Chemotherapy|"Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)~Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)~Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)"
1260919|NCT00039130|E1|Reported Event|Rituximab With High Intensity Chemotherapy|"Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)~Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)~Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)"
1260920|NCT00038948|B3|Baseline|Total|Total of all reporting groups
1260921|NCT00038948|B2|Baseline|CNI Continuation in Stable Renal Transplant Recipients|Continued calcineurin inhibitor immunosuppression therapy
1260922|NCT00038948|B1|Baseline|SRL Conversion in Stable Renal Transplant Recipients|Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy.
1260923|NCT00038948|P2|Participant Flow|CNI Continuation in Stable Renal Transplant Recipients|Continued calcineurin inhibitor immunosuppression therapy
1260924|NCT00038948|P1|Participant Flow|SRL Conversion in Stable Renal Transplant Recipients|Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy.
1260925|NCT00038948|O4|Outcome|CNI Continuation Strata >40.0 mL/Min|Continued calcineurin inhibitor therapy
1260926|NCT00038948|O3|Outcome|SRL Conversion Strata >40.0 mL/Min|Conversion from calcineurin inhibitor immunosuppression to Sirolimus-based immunosuppression
1260927|NCT00038948|O2|Outcome|CNI Continuation Strata 20.0-40.0 mL/Min|Continued calcineurin inhibitor therapy
1260928|NCT00038948|O1|Outcome|SRL Conversion Strata 20.0-40.0 mL/Min|Conversion from calcineurin inhibitor immunosuppression to Sirolimus-based immunosuppression
1260931|NCT00038948|O2|Outcome|CNI Continuation Strata 20.0-40.0 mL/Min|Continued calcineurin inhibitor immunosuppression therapy in renal transplant recipients.
1260932|NCT00038948|O1|Outcome|SRL Conversion Strata 20.0-40.0 mL/Min|Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy in stable renal transplant recipients
1260933|NCT00038948|E2|Reported Event|CNI Continuation in Stable Renal Transplant Recipients|Continued calcineurin inhibitor immunosuppression therapy
1260934|NCT00038948|E1|Reported Event|SRL Conversion in Stable Renal Transplant Recipients|Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy.
1260935|NCT00038857|B1|Baseline|CD34 PBPC|Melphalan 140 mg/m^2 given IV for one day. Thiotepa 10 mg/kg given IV for one day. Fludarabine 40 mg/m^2 given IV daily for four days. Rabbit ATG 1.5 mg/kg given IV daily for four days. Stem Cell Infusion of CD34+ Selected Cells given on Day 0.
1260936|NCT00038857|P1|Participant Flow|CD34 PBPC|Melphalan 140 mg/m^2 given IV for one day. Thiotepa 10 mg/kg given IV for one day. Fludarabine 40 mg/m^2 given IV daily for four days. Rabbit ATG 1.5 mg/kg given IV daily for four days. Stem Cell Infusion of CD34+ Selected Cells given on Day 0.
1260937|NCT00038857|O1|Outcome|Melphalan + Thiotepa + Fludarabine + Rabbit ATG + CD34 PBPC|Melphalan 140 mg/m^2 given for one day. Thiotepa 10 mg/kg given for one day. Fludarabine 40 mg/m^2 given daily for four days. Rabbit ATG 1.5 mg/kg given daily for four days. Infusion of CD34+ Selected Cells given on Day 0.
1260938|NCT00038857|E1|Reported Event|CD34 PBPC|Melphalan 140 mg/m^2 given IV for one day. Thiotepa 10 mg/kg given IV for one day. Fludarabine 40 mg/m^2 given IV daily for four days. Rabbit ATG 1.5 mg/kg given IV daily for four days. Stem Cell Infusion of CD34+ Selected Cells given on Day 0.
1260939|NCT00038610|B1|Baseline|Hyper-CVAD + Imatinib|Imatinib 600 mg orally days 1-14, course 1, & 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m^2 IV day 4; Vincristine 2 mg IV days 4 & 11; & Dexamethasone 40 mg IV or orally daily days 1-4 & 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
1260940|NCT00038610|P1|Participant Flow|Hyper-CVAD + Imatinib|Imatinib 600 mg orally days 1-14, course 1, & 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m^2 IV day 4; Vincristine 2 mg IV days 4 & 11; & Dexamethasone 40 mg IV or orally daily days 1-4 & 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
1260941|NCT00038610|O1|Outcome|Hyper-CVAD + Imatinib|Imatinib 600 mg orally days 1-14, course 1, & 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m^2 IV day 4; Vincristine 2 mg IV days 4 & 11; & Dexamethasone 40 mg IV or orally daily days 1-4 & 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
1260942|NCT00038610|O1|Outcome|Hyper-CVAD + Imatinib|Imatinib 600 mg orally days 1-14, course 1, & 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m^2 IV day 4; Vincristine 2 mg IV days 4 & 11; & Dexamethasone 40 mg IV or orally daily days 1-4 & 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
1260943|NCT00038610|O1|Outcome|Hyper-CVAD + Imatinib|Imatinib 600 mg orally days 1-14, course 1, & 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m^2 IV day 4; Vincristine 2 mg IV days 4 & 11; & Dexamethasone 40 mg IV or orally daily days 1-4 & 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
1260944|NCT00038610|E1|Reported Event|Hyper-CVAD + Imatinib|Imatinib 600 mg orally days 1-14, course 1, & 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m^2 IV day 4; Vincristine 2 mg IV days 4 & 11; & Dexamethasone 40 mg IV or orally daily days 1-4 & 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
1260945|NCT00038467|B3|Baseline|Total|Total of all reporting groups
1260946|NCT00038467|B2|Baseline|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
1261048|NCT00037830|O2|Outcome|Delayed-Start Group|Group that was randomized to receive placebo for 24 weeks
1260947|NCT00038467|B1|Baseline|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
1260948|NCT00038467|P2|Participant Flow|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
1260949|NCT00038467|P1|Participant Flow|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
1260950|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
1260951|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
1260952|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
1260953|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
1260954|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
1260955|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
1260956|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
1260957|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
1260958|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
1260959|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
1260960|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
1260961|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
1260962|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
1260963|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
1260964|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
1260965|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
1260966|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
1261049|NCT00037830|O1|Outcome|Early-Start Group|Group that was randomized to receive GM1 ganglioside 24 weeks
1260967|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
1260968|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
1260969|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
1260970|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
1260971|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
1260972|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
1260973|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
1260974|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
1260975|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
1260976|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
1260977|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
1260978|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
1260979|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
1260980|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
1260981|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
1260982|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
1260983|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
1260984|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
1260985|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
1260986|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
1261050|NCT00037830|O2|Outcome|Delayed-Start Group|Group that was randomized to receive placebo for 24 weeks
1260987|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
1260988|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
1260989|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
1260990|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
1260991|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
1260992|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
1260993|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
1260994|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
1260995|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
1260996|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
1260997|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
1260998|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
1260999|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
1261000|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
1261001|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
1261002|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
1261003|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
1261004|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
1261005|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
1261006|NCT00038467|E2|Reported Event|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
1261051|NCT00037830|O1|Outcome|Early-Start Group|Group that was randomized to receive GM1 ganglioside 24 weeks
1261007|NCT00038467|E1|Reported Event|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
1261008|NCT00038103|B3|Baseline|Total|Total of all reporting groups
1261009|NCT00038103|B2|Baseline|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
1261010|NCT00038103|B1|Baseline|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
1261011|NCT00038103|P2|Participant Flow|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
1261012|NCT00038103|P1|Participant Flow|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
1261013|NCT00038103|O2|Outcome|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
1261014|NCT00038103|O1|Outcome|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
1261015|NCT00038103|O2|Outcome|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
1261016|NCT00038103|O1|Outcome|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
1261017|NCT00038103|O2|Outcome|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
1261018|NCT00038103|O1|Outcome|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
1261019|NCT00038103|O2|Outcome|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
1261020|NCT00038103|O1|Outcome|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
1261021|NCT00038103|O2|Outcome|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
1261022|NCT00038103|O1|Outcome|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
1261023|NCT00038103|O2|Outcome|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
1261024|NCT00038103|O1|Outcome|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
1261025|NCT00038103|O2|Outcome|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
1261026|NCT00038103|O1|Outcome|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
1261027|NCT00038103|O2|Outcome|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
1261028|NCT00038103|O1|Outcome|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
1261029|NCT00038103|E2|Reported Event|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
1261030|NCT00038103|E1|Reported Event|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
1261031|NCT00037830|B4|Baseline|Total|Total of all reporting groups
1261032|NCT00037830|B3|Baseline|Comparison Group|This group of PD patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This group was not statistically compared to the treatment groups since this group was not randomized.
1261033|NCT00037830|B2|Baseline|Delayed-Start Group|Phase I: Thiry eight subjects were randomized to receive placebo for 24 weeks.
1261034|NCT00037830|B1|Baseline|Early-Start Group|Phase I: Thirty nine subjects were randomized to receive GM1 for 24 weeks.
1261035|NCT00037830|P3|Participant Flow|Comparison Group|This group of PD patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This group was not statistically compared to the treatment groups since this group was not randomized.
1261036|NCT00037830|P2|Participant Flow|Delayed-Start Group|Phase I: Thiry eight subjects were randomized to receive placebo for 24 weeks.
1261037|NCT00037830|P1|Participant Flow|Early-Start Group|Phase I: Thirty nine subjects were randomized to receive GM1 for 24 weeks.
1261038|NCT00037830|O1|Outcome|Comparison Group|This group of PD patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This group was not statistically compared to the treatment groups since this group was not randomized.
1261039|NCT00037830|O1|Outcome|Comparison Group|This group of PD patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This group was not statistically compared to the treatment groups since this group was not randomized.
1261040|NCT00037830|O1|Outcome|Comparison Group|This group of PD patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This group was not statistically compared to the treatment groups since this group was not randomized.
1261041|NCT00037830|O1|Outcome|Comparison Group|This group of PD patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This group was not statistically compared to the treatment groups since this group was not randomized.
1261042|NCT00037830|O2|Outcome|Delayed-Start Group|Group that was randomized to receive placebo for 24 weeks
1261043|NCT00037830|O1|Outcome|Early-Start Group|Group that was randomized to receive GM1 ganglioside 24 weeks
1261044|NCT00037830|O2|Outcome|Delayed-Start Group|Group that was randomized to receive placebo for 24 weeks
1261045|NCT00037830|O1|Outcome|Early-Start Group|Group that was randomized to receive GM1 ganglioside 24 weeks
1261046|NCT00037830|O2|Outcome|Delayed-Start Group|Group that was randomized to receive placebo for 24 weeks
1261047|NCT00037830|O1|Outcome|Early-Start Group|Group that was randomized to receive GM1 ganglioside 24 weeks
1261053|NCT00037830|O1|Outcome|Early-Start Group|Group that was randomized to receive GM1 ganglioside 24 weeks
1261054|NCT00037830|E3|Reported Event|Comparison Group|This group of PD patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This group was not statistically compared to the treatment groups since this group was not randomized.
1261055|NCT00037830|E2|Reported Event|Delayed-Start Group|Phase I: Thiry eight subjects were randomized to receive placebo for 24 weeks.
1261056|NCT00037830|E1|Reported Event|Early-Start Group|Phase I: Thirty nine subjects were randomized to receive GM1 for 24 weeks.
1261057|NCT00036569|B1|Baseline|Interferon Alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
1261058|NCT00036569|P1|Participant Flow|Interferon Alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
1261059|NCT00036569|O1|Outcome|Interferon Alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
1261060|NCT00036569|O2|Outcome|QOL Score at Follow-up|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
1261061|NCT00036569|O1|Outcome|QOL Score at Baseline|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
1261062|NCT00036569|O1|Outcome|Interferon Alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
1261063|NCT00036569|O1|Outcome|Interferon Alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
1261064|NCT00036569|O1|Outcome|Interferon Alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
1261065|NCT00036569|E1|Reported Event|Interferon Alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
1261066|NCT00036270|B3|Baseline|Total|Total of all reporting groups
1261067|NCT00036270|B2|Baseline|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
1261068|NCT00036270|B1|Baseline|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years.
1261069|NCT00036270|P2|Participant Flow|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
1261070|NCT00036270|P1|Participant Flow|Exemestane|Exemestane (Aromasin®) 25 milligram (mg) once daily (QD) for 5 years.
1261071|NCT00036270|O2|Outcome|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
1261072|NCT00036270|O1|Outcome|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years.
1261073|NCT00036270|O2|Outcome|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
1261074|NCT00036270|O1|Outcome|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years.
1261075|NCT00036270|O2|Outcome|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
1261076|NCT00036270|O1|Outcome|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years.
1261077|NCT00036270|O2|Outcome|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
1261078|NCT00036270|O1|Outcome|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years.
1261079|NCT00036270|O2|Outcome|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
1261080|NCT00036270|O1|Outcome|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years.
1261081|NCT00036270|O2|Outcome|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
1261082|NCT00036270|O1|Outcome|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years.
1261083|NCT00036270|E2|Reported Event|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years
1261084|NCT00036270|E1|Reported Event|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
1261085|NCT00035932|B4|Baseline|Total|Total of all reporting groups
1261086|NCT00035932|B3|Baseline|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261087|NCT00035932|B2|Baseline|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261088|NCT00035932|B1|Baseline|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261149|NCT00035932|O1|Outcome|ATV 300 mg / RTV|ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice treated participants (CD4 Cell Count Change from Baseline [cells/mm3] Mean [SE] = 80 [21])
1261089|NCT00035932|P3|Participant Flow|LPV / RTV|"lopinavir (LPV)/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261090|NCT00035932|P2|Participant Flow|ATV 400 mg / SQV|"ATV 400 mg + saquinavir (SQV) 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261091|NCT00035932|P1|Participant Flow|ATV 300 mg / RTV|"atazanavir (ATV) 300 mg + ritonavir (RTV) 100 mg + tenofovir (TDF) 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261092|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261093|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261094|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261095|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261096|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261097|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261098|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261099|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261100|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261101|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261102|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261103|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261104|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261105|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261106|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261107|NCT00035932|O2|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261108|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261109|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261110|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261111|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261112|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261113|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261114|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261115|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261116|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261117|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261118|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261119|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261120|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261121|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261122|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261123|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261124|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261125|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261126|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261127|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261128|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261129|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261130|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261131|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261132|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261133|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261134|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261135|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261136|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261137|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261138|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261139|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261140|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261141|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261142|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261143|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261144|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261145|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261146|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261147|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261148|NCT00035932|O2|Outcome|ATV 400 mg / SQV|ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = 56 [20])
1261430|NCT00031486|P2|Participant Flow|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
1261150|NCT00035932|O2|Outcome|ATV 400 mg / SQV|ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = 56 [20])
1261151|NCT00035932|O1|Outcome|ATV 300 mg / RTV|ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice treated participants (CD4 Cell Count Change from Baseline [cells/mm3] Mean [SE] = 80 [21])
1261152|NCT00035932|O2|Outcome|ATV 400 mg / SQV|ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = -1.57 [0.3])
1261153|NCT00035932|O1|Outcome|ATV 300 mg / RTV|ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = -1.91 [0.19])
1261154|NCT00035932|O2|Outcome|ATV 400 mg / SQV|ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = -1.57 [0.3])
1261155|NCT00035932|O1|Outcome|ATV 300 mg / RTV|ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = -1.91 [0.19])
1261156|NCT00035932|O2|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261157|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261158|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261159|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261160|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261161|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261162|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261163|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261164|NCT00035932|O2|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261165|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261166|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261167|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261168|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261169|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261170|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261171|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261172|NCT00035932|O2|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261173|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261174|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261175|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261176|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261177|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261178|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261179|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261431|NCT00031486|P1|Participant Flow|Valacyclovir|four 500 mg tablets 3 times a day for 90 days
1261436|NCT00031486|O2|Outcome|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
1261180|NCT00035932|O2|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261181|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261182|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261183|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261184|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261185|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261186|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261187|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261188|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261189|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261190|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261191|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261192|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261193|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261194|NCT00035932|O2|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261195|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261196|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261197|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261198|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261199|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261200|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261201|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261202|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261203|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261204|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261205|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261206|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261207|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261208|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261209|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261432|NCT00031486|O3|Outcome|Total|
1261210|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
1261211|NCT00035932|E3|Reported Event|LPV/RTV|lopinavir (LPV)/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
1261212|NCT00035932|E2|Reported Event|ATV400/SQV|ATV 400 mg + saquinavir (SQV) 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
1261213|NCT00035932|E1|Reported Event|ATV300/RTV|atazanavir (ATV) 300 mg + ritonavir (RTV) 100 mg + tenofovir (TDF) 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
1261214|NCT00035815|B3|Baseline|Total|Total of all reporting groups
1261215|NCT00035815|B2|Baseline|Placebo|Placebo group received the equal volume (based on kg of body weight) of the inert suspension vehicle in which the IGF-1 was suspended.
1261216|NCT00035815|B1|Baseline|IGF-1|The IGF-1 arm was the active treatment group. They received 0.05 mg/kg body weight administered subcutaneously twice daily.
1261217|NCT00035815|P2|Participant Flow|Placebo|Placebo group received the equal volume (based on kg of body weight) of the inert suspension vehicle in which the IGF-1 was suspended.
1261218|NCT00035815|P1|Participant Flow|IGF-1|The insulin-like growth factor type 1 (IGF-1) arm was the active treatment group. They received 0.05 mg/kg body weight administered subcutaneously twice daily.
1261219|NCT00035815|O2|Outcome|Placebo|Placebo group received the equal volume (based on kg of body weight) of the inert suspension vehicle in which the IGF-1 was suspended.
1261220|NCT00035815|O1|Outcome|IGF-1|The IGF-1 arm was the active treatment group. They received 0.05 mg/kg body weight administered subcutaneously twice daily.
1261221|NCT00035815|O2|Outcome|Placebo|Placebo group received the equal volume (based on kg of body weight) of the inert suspension vehicle in which the IGF-1 was suspended.
1261222|NCT00035815|O1|Outcome|IGF-1|The IGF-1 arm was the active treatment group. They received 0.05 mg/kg body weight administered subcutaneously twice daily.
1261223|NCT00035815|O2|Outcome|Placebo|Placebo group received the equal volume (based on kg of body weight) of the inert suspension vehicle in which the IGF-1 was suspended.
1261224|NCT00035815|O1|Outcome|IGF-1|The IGF-1 arm was the active treatment group. They received 0.05 mg/kg body weight administered subcutaneously twice daily.
1261225|NCT00035815|E2|Reported Event|Placebo|Placebo group received the equal volume (based on kg of body weight) of the inert suspension vehicle in which the IGF-1 was suspended.
1261226|NCT00035815|E1|Reported Event|IGF-1|The IGF-1 arm was the active treatment group. They received 0.05 mg/kg body weight administered subcutaneously twice daily.
1261227|NCT00035555|B4|Baseline|Total|Total of all reporting groups
1261228|NCT00035555|B3|Baseline|Cyclosporine Regimen|Cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261229|NCT00035555|B2|Baseline|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261230|NCT00035555|B1|Baseline|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261231|NCT00035555|P3|Participant Flow|Cyclosporine Regimen|Cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261295|NCT00033657|O2|Outcome|Paclitaxel / Cisplatin / RT (Arm B)|"Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles."
1261232|NCT00035555|P2|Participant Flow|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261233|NCT00035555|P1|Participant Flow|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261234|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261235|NCT00035555|O2|Outcome|Belatacept:Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261236|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261237|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261238|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261239|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261296|NCT00033657|O1|Outcome|Cisplatin / Irinotecan / RT (Arm A)|"Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
1261240|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261241|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261242|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261243|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261244|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261245|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261246|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261247|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261297|NCT00033657|E4|Reported Event|Adjuvant_Paclitaxel / Irinotecan / RT ( Arm B)|
1261298|NCT00033657|E3|Reported Event|Adjuvant_Cisplatin / Irinotecan / RT ( Arm A)|Adjuvant chemotherapy toxicities in treated patients
1261349|NCT00033371|E1|Reported Event|Arm I: Celecoxib and Placebo|Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days).
1261350|NCT00033293|B3|Baseline|Total|Total of all reporting groups
1261248|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261249|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261250|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261251|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261252|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261253|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261254|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261255|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261299|NCT00033657|E2|Reported Event|Neoadjuvant_Paclitaxel / Cisplatin / RT (Arm B)|"Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles."
1261256|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261257|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261258|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261259|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261260|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261261|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261262|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261263|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261300|NCT00033657|E1|Reported Event|Neoadjuvant_Cisplatin / Irinotecan / RT (Arm A)|"Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
1261264|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261265|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261266|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261267|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261268|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261269|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261270|NCT00035555|E3|Reported Event|Cyclosporin Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261271|NCT00035555|E2|Reported Event|Belatacept: More-intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261301|NCT00033631|B3|Baseline|Total|Total of all reporting groups
1261302|NCT00033631|B2|Baseline|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
1261272|NCT00035555|E1|Reported Event|Belatacept: Less-intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
1261273|NCT00033917|B3|Baseline|Total|Total of all reporting groups
1261274|NCT00033917|B2|Baseline|Placebo|Group randomized to an equal volume of placebo
1261275|NCT00033917|B1|Baseline|Indomethacin|subjects randomized to early low dose indomethacin
1261276|NCT00033917|P2|Participant Flow|IVH Negative Placebo|These subjects also had no evidence for IVH at 6 - 12 hours. They were randomized to an equal volume of placebo.
1261277|NCT00033917|P1|Participant Flow|IVH Negative Indomethacin|Those subjects with no evidence for intraventricular hemorrhage (IVH) at 6 - 12 postnatal hours. These subjects were randomized to early low-dose indomethacin (0.1 mg/kg/d for 3 doses).
1261278|NCT00033917|O4|Outcome|Placebo - IVH|Randomized to placebo; had IVH
1261279|NCT00033917|O3|Outcome|Placebo - no IVH|Randomized to placebo - no IVH
1261280|NCT00033917|O2|Outcome|Indomethacin - IVH|Randomized to indomethacin; had IVH
1261281|NCT00033917|O1|Outcome|Indomethacin - no IVH|Subjects randomized to indomethacin and had no IVH
1261282|NCT00033917|O2|Outcome|Placebo|Group randomized to an equal volume of placebo
1261283|NCT00033917|O1|Outcome|Indomethacin|subjects randomized to early low dose indomethacin
1261284|NCT00033917|E2|Reported Event|IVH Negative Placebo|These subjects also had no evidence for IVH at 6 - 12 hours. They were randomized to an equal volume of placebo.
1261285|NCT00033917|E1|Reported Event|IVH Negative Indomethacin|Those subjects with no evidence for intraventricular hemorrhage (IVH) at 6 - 12 postnatal hours. These subjects were randomized to early low-dose indomethacin (0.1 mg/kg/d for 3 doses).
1261286|NCT00033657|B3|Baseline|Total|Total of all reporting groups
1261287|NCT00033657|B2|Baseline|Paclitaxel / Cisplatin / RT (Arm B)|"Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles."
1261288|NCT00033657|B1|Baseline|Cisplatin / Irinotecan / RT (Arm A)|"Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
1261289|NCT00033657|P2|Participant Flow|Paclitaxel / Cisplatin / RT (Arm B)|"Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles."
1261290|NCT00033657|P1|Participant Flow|Cisplatin / Irinotecan / RT (Arm A)|"Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
1261291|NCT00033657|O2|Outcome|Paclitaxel / Cisplatin / RT (Arm B)|"Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles."
1261292|NCT00033657|O1|Outcome|Cisplatin / Irinotecan / RT (Arm A)|"Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
1261293|NCT00033657|O2|Outcome|Paclitaxel / Cisplatin / RT (Arm B)|"Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles."
1261294|NCT00033657|O1|Outcome|Cisplatin / Irinotecan / RT (Arm A)|"Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
1261347|NCT00033371|O1|Outcome|Arm I: Celecoxib and Placebo|Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days).
1261433|NCT00031486|O2|Outcome|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
1261303|NCT00033631|B1|Baseline|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
1261304|NCT00033631|P2|Participant Flow|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
1261305|NCT00033631|P1|Participant Flow|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
1261306|NCT00033631|O2|Outcome|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
1261307|NCT00033631|O1|Outcome|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
1261308|NCT00033631|O2|Outcome|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
1261309|NCT00033631|O1|Outcome|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
1261310|NCT00033631|O2|Outcome|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
1261311|NCT00033631|O1|Outcome|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
1261312|NCT00033631|O2|Outcome|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
1261313|NCT00033631|O1|Outcome|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
1261314|NCT00033631|O2|Outcome|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
1261315|NCT00033631|O1|Outcome|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
1261316|NCT00033631|O2|Outcome|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
1261317|NCT00033631|O1|Outcome|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
1261318|NCT00033631|O2|Outcome|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
1261319|NCT00033631|O1|Outcome|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
1261348|NCT00033371|E2|Reported Event|Arm II: Celecoxib and Eflornithine|Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of < 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of > 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).
1261320|NCT00033631|E2|Reported Event|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 44 Fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
1261321|NCT00033631|E1|Reported Event|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
1261322|NCT00033540|B1|Baseline|Capecitabine + Gemcitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
1261323|NCT00033540|P1|Participant Flow|Capecitabine + Gemcitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
1261324|NCT00033540|O1|Outcome|Capecitabine + Gemcitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
1261325|NCT00033540|O1|Outcome|Capecitabine + Gemcitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
1261326|NCT00033540|O1|Outcome|Gemcitabine and Capecitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
1261327|NCT00033540|O1|Outcome|Capecitabine + Gemcitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
1261328|NCT00033540|O1|Outcome|Capecitabine + Gemcitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
1261329|NCT00033540|E1|Reported Event|Gemcitabine and Capecitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
1261330|NCT00033514|B3|Baseline|Total|Total of all reporting groups
1261331|NCT00033514|B2|Baseline|Treatment Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol."
1261332|NCT00033514|B1|Baseline|Treatment Phase 1|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol."
1261333|NCT00033514|P2|Participant Flow|Treatment Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol."
1261334|NCT00033514|P1|Participant Flow|Treatment Phase 1|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol."
1261335|NCT00033514|O1|Outcome|Treatment Phase 1|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol."
1261336|NCT00033514|O1|Outcome|Treatment Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride:150 mg daily."
1261337|NCT00033514|O1|Outcome|Treatment Phase 1 Plus Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 50mg daily, 100 mg daily and 150 mg daily."
1261338|NCT00033514|O1|Outcome|Treatment Phase 1 Plus Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 150 mg daily."
1261339|NCT00033514|O1|Outcome|Treatment Phase 1 Plus Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 150 mg daily."
1261340|NCT00033514|E1|Reported Event|Treatment Phase 1 Plus Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 50mg daily, 100 mg daily and 150 mg daily."
1261341|NCT00033371|B3|Baseline|Total|Total of all reporting groups
1261342|NCT00033371|B2|Baseline|Arm II: Celecoxib and Eflornithine|Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of < 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of > 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).
1261343|NCT00033371|B1|Baseline|Arm I: Celecoxib and Placebo|Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days).
1261344|NCT00033371|P2|Participant Flow|Arm II: Celecoxib and Eflornithine|Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of < 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of > 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).
1261345|NCT00033371|P1|Participant Flow|Arm I: Celecoxib and Placebo|Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days).
1261346|NCT00033371|O2|Outcome|Arm II: Celecoxib and Eflornithine|Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of < 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of > 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).
1261351|NCT00033293|B2|Baseline|Arm II (Chemotherapy, Observation)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.~Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I."
1261352|NCT00033293|B1|Baseline|Arm I (Chemotherapy, Immunoglobulin Therapy)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.~Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH)."
1261353|NCT00033293|P2|Participant Flow|Arm II (Chemotherapy, Observation)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.~Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I."
1261354|NCT00033293|P1|Participant Flow|Arm I (Chemotherapy, Immunoglobulin Therapy)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.~Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH)."
1261355|NCT00033293|O2|Outcome|Arm II (Chemotherapy, Observation)|Randomized to chemotherapy, observation
1261356|NCT00033293|O1|Outcome|Arm I (Chemotherapy, Immunoglobulin Therapy)|Randomized to chemotherapy, immunoglobulin therapy.
1261357|NCT00033293|O2|Outcome|Arm II (Chemotherapy, Observation)|Randomized to chemotherapy, observation
1261358|NCT00033293|O1|Outcome|Arm I (Chemotherapy, Immunoglobulin Therapy)|Randomized to chemotherapy, immunoglobulin therapy.
1261359|NCT00033293|O2|Outcome|Arm II (Chemotherapy, Observation)|Randomized to chemotherapy, observation
1261360|NCT00033293|O1|Outcome|Arm I (Chemotherapy, Immunoglobulin Therapy)|Randomized to chemotherapy, immunoglobulin therapy.
1261361|NCT00033293|O2|Outcome|Arm II (Chemotherapy, Observation)|Randomized to chemotherapy, observation
1261362|NCT00033293|O1|Outcome|Arm I (Chemotherapy, Immunoglobulin Therapy)|Randomized to chemotherapy, immunoglobulin therapy.
1261363|NCT00033293|O2|Outcome|Arm II (Chemotherapy, Observation)|Randomized to chemotherapy, observation
1261364|NCT00033293|O1|Outcome|Arm I (Chemotherapy, Immunoglobulin Therapy)|Randomized to chemotherapy, immunoglobulin therapy.
1261365|NCT00033293|O2|Outcome|Arm II (Chemotherapy, Observation)|Randomized to chemotherapy, observation
1261366|NCT00033293|O1|Outcome|Arm I (Chemotherapy, Immunoglobulin Therapy)|Randomized to chemotherapy, immunoglobulin therapy.
1261367|NCT00033293|O2|Outcome|Arm II (Chemotherapy, Observation)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.~Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I."
1261368|NCT00033293|O1|Outcome|Arm I (Chemotherapy, Immunoglobulin Therapy)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.~Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH)."
1261405|NCT00032487|O1|Outcome|Arm 1|Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
1261406|NCT00032487|O2|Outcome|Arm 2|Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Arm 1
1261407|NCT00032487|O1|Outcome|Arm 1|Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
1261369|NCT00033293|E2|Reported Event|Arm II (Chemotherapy, Observation)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.~Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I."
1261370|NCT00033293|E1|Reported Event|Arm I (Chemotherapy, Immunoglobulin Therapy)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.~Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH)."
1261371|NCT00032630|B3|Baseline|Total|Total of all reporting groups
1261372|NCT00032630|B2|Baseline|Off Pump|Coronary artery bypass performed on a beating heart with no heart-lung machine
1261373|NCT00032630|B1|Baseline|On Pump|Coronary artery bypass performed on a non beating heart using a heart-lung machine
1261374|NCT00032630|P2|Participant Flow|Off Pump|Coronary artery bypass performed on a beating heart with no heart-lung machine
1261375|NCT00032630|P1|Participant Flow|On Pump|Coronary artery bypass performed on a non beating heart using a heart-lung machine
1261376|NCT00032630|O2|Outcome|Off Pump|Coronary artery bypass performed on a beating heart with no heart-lung machine
1261377|NCT00032630|O1|Outcome|On Pump|Coronary artery bypass performed on a non beating heart using a heart-lung machine
1261378|NCT00032630|O2|Outcome|Off Pump|Coronary artery bypass performed on a beating heart with no heart-lung machine
1261379|NCT00032630|O1|Outcome|On Pump|Coronary artery bypass performed on a non beating heart using a heart-lung machine
1261380|NCT00032630|E2|Reported Event|Off Pump|Coronary artery bypass performed on a beating heart with no heart-lung machine
1261381|NCT00032630|E1|Reported Event|On Pump|Coronary artery bypass performed on a non beating heart using a heart-lung machine
1261382|NCT00032591|B3|Baseline|Total|Total of all reporting groups
1261383|NCT00032591|B2|Baseline|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
1261384|NCT00032591|B1|Baseline|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
1261385|NCT00032591|P2|Participant Flow|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
1261386|NCT00032591|P1|Participant Flow|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
1261387|NCT00032591|O2|Outcome|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
1261388|NCT00032591|O1|Outcome|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
1261389|NCT00032591|O2|Outcome|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
1261390|NCT00032591|O1|Outcome|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
1261391|NCT00032591|O2|Outcome|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
1261392|NCT00032591|O1|Outcome|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
1261393|NCT00032591|O2|Outcome|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
1261394|NCT00032591|O1|Outcome|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
1261395|NCT00032591|O2|Outcome|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
1261396|NCT00032591|O1|Outcome|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
1261397|NCT00032591|E2|Reported Event|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
1261398|NCT00032591|E1|Reported Event|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
1261399|NCT00032487|B3|Baseline|Total|Total of all reporting groups
1261400|NCT00032487|B2|Baseline|Arm 2/Intensive Glycemic Control|Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Standard glycemic control
1261401|NCT00032487|B1|Baseline|Arm 1/Standard Glycemic Control|Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
1261402|NCT00032487|P2|Participant Flow|Intensive Glycemic Control|Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Arm 1
1261403|NCT00032487|P1|Participant Flow|Standard Glycemic Control|Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
1261404|NCT00032487|O2|Outcome|Arm 2|Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Arm 1
1261408|NCT00032487|E2|Reported Event|Arm 2|Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Arm 1
1261409|NCT00032487|E1|Reported Event|Arm 1|Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
1261410|NCT00031694|B1|Baseline|Treatment (Paclitaxel, Bryostatin 1)|"Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV~bryostatin 1: Given IV~pharmacological study: Correlative studies"
1261411|NCT00031694|P1|Participant Flow|Treatment (Paclitaxel, Bryostatin 1)|"Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV~bryostatin 1: Given IV~pharmacological study: Correlative studies"
1261412|NCT00031694|O1|Outcome|Treatment (Paclitaxel, Bryostatin 1)|"Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV~bryostatin 1: Given IV~pharmacological study: Correlative studies"
1261413|NCT00031694|E1|Reported Event|Treatment (Paclitaxel, Bryostatin 1)|"Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV~bryostatin 1: Given IV~pharmacological study: Correlative studies"
1261414|NCT00031551|B3|Baseline|Total|Total of all reporting groups
1261415|NCT00031551|B2|Baseline|Pilot Study|Participants were enrolled in the pilot study to collect descriptive data about pain perception and laboratory techniques.
1261416|NCT00031551|B1|Baseline|Main Study Participants|"Participants were randomized to one of the following two interventions but the study was not unblinded.~Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.~Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first."
1261417|NCT00031551|P2|Participant Flow|Pilot Study|Participants were enrolled in the pilot study to collect descriptive data about pain perception and laboratory techniques.
1261418|NCT00031551|P1|Participant Flow|Main Study Participants|"Participants were randomized to one of the following two interventions but the study was not unblinded.~Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.~Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first."
1261419|NCT00031551|O1|Outcome|Pilot Study|Participants were enrolled in the pilot study to collect descriptive data about pain perception and laboratory techniques.
1261420|NCT00031551|O2|Outcome|Pilot Study: Day 9 After CT Scores|
1261421|NCT00031551|O1|Outcome|Pilot Study: Baseline Scores|Participants were enrolled in the pilot study to collect descriptive data about pain perception and laboratory techniques.
1261422|NCT00031551|O1|Outcome|Main Study Participants|"Participants were randomized to one of the following two interventions but the study was not unblinded.~Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.~Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first."
1261423|NCT00031551|O2|Outcome|Main Study: Placebo Mouthwash|"Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first.~Placebo"
1261424|NCT00031551|O1|Outcome|Main Study: Etanercept Mouthwash|"Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.~Etanercept"
1261425|NCT00031551|E2|Reported Event|Pilot Study|Participants were enrolled in the pilot study to collect descriptive data about pain perception and laboratory techniques.
1261426|NCT00031551|E1|Reported Event|Main Study Participants|"Participants were randomized to one of the following two interventions but the study was not unblinded.~Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.~Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first."
1261427|NCT00031486|B3|Baseline|Total|Total of all reporting groups
1261428|NCT00031486|B2|Baseline|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
1261429|NCT00031486|B1|Baseline|Valacyclovir|four 500 mg tablets 3 times a day for 90 days
1261439|NCT00031486|O2|Outcome|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
1261440|NCT00031486|O1|Outcome|Valacyclovir|four 500 mg tablets 3 times a day for 90 days
1261441|NCT00031486|O3|Outcome|Total|
1261442|NCT00031486|O2|Outcome|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
1261443|NCT00031486|O1|Outcome|Valacyclovir|four 500 mg tablets taken 3 times a day for 90 days
1261444|NCT00031486|O2|Outcome|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
1261445|NCT00031486|O1|Outcome|Valacyclovir|four 500 mg tablets taken 3 times a day for 90 days
1261446|NCT00031486|O3|Outcome|Total|
1261447|NCT00031486|O2|Outcome|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
1261448|NCT00031486|O1|Outcome|Valacyclovir|four 500 mg tablets taken 3 times a day for 90 days
1261449|NCT00031486|O3|Outcome|Total|
1261450|NCT00031486|O2|Outcome|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
1261451|NCT00031486|O1|Outcome|Valacyclovir|four 500 mg tablets taken 3 times a day for 90 days
1261452|NCT00031486|E2|Reported Event|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
1261453|NCT00031486|E1|Reported Event|Valacyclovir|four 500 mg tablets 3 times a day for 90 days
1261454|NCT00031460|B3|Baseline|Total|Total of all reporting groups
1261455|NCT00031460|B2|Baseline|Placebo|Identical volume as acyclovir.
1261456|NCT00031460|B1|Baseline|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
1261457|NCT00031460|P2|Participant Flow|Placebo|Identical volume as acyclovir.
1261458|NCT00031460|P1|Participant Flow|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
1261459|NCT00031460|O2|Outcome|Placebo|Identical volume as acyclovir.
1261460|NCT00031460|O1|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
1261461|NCT00031460|O2|Outcome|Placebo|Identical volume as acyclovir.
1261462|NCT00031460|O1|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
1261463|NCT00031460|O2|Outcome|Placebo|Identical volume as acyclovir.
1261464|NCT00031460|O1|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
1261465|NCT00031460|O2|Outcome|Placebo|Identical volume as acyclovir.
1261466|NCT00031460|O1|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
1261467|NCT00031460|E2|Reported Event|Placebo|Identical volume as acyclovir.
1261468|NCT00031460|E1|Reported Event|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
1261469|NCT00031447|B3|Baseline|Total|Total of all reporting groups
1261470|NCT00031447|B2|Baseline|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
1261471|NCT00031447|B1|Baseline|Placebo|Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
1261472|NCT00031447|P2|Participant Flow|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
1261473|NCT00031447|P1|Participant Flow|Placebo|Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
1261474|NCT00031447|O2|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
1261475|NCT00031447|O1|Outcome|Placebo|Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
1261476|NCT00031447|O2|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
1261477|NCT00031447|O1|Outcome|Placebo|Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
1261478|NCT00031447|O2|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
1261479|NCT00031447|O1|Outcome|Placebo|Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
1261480|NCT00031447|O2|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
1261481|NCT00031447|O1|Outcome|Placebo|Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
1261482|NCT00031447|E2|Reported Event|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
1261483|NCT00031447|E1|Reported Event|Placebo|Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
1261484|NCT00030992|B1|Baseline|BMS-247550|One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m^2/day for a total per cycle dose of 30 mg/m^2
1261485|NCT00030992|P1|Participant Flow|BMS-247550|One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m^2/day for a total per cycle dose of 30 mg/m^2
1261486|NCT00030992|O1|Outcome|BMS-247550|One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m^2/day for a total per cycle dose of 30 mg/m^2
1261487|NCT00030992|O1|Outcome|BMS-247550|One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m^2/day for a total per cycle dose of 30 mg/m^2
1261488|NCT00030992|E1|Reported Event|BMS-247550|One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m^2/day for a total per cycle dose of 30 mg/m^2
1261489|NCT00030901|B3|Baseline|Total|Total of all reporting groups
1261490|NCT00030901|B2|Baseline|Placebo|Patients receive oral placebo once daily for 3 years
1261491|NCT00030901|B1|Baseline|Selenium|Patients receive oral selenium once daily for 3 years
1261492|NCT00030901|P3|Participant Flow|Placebo|Patients receive oral placebo once daily for 3 years
1261493|NCT00030901|P2|Participant Flow|Selenium|Patients receive oral selenium once daily for 3 years
1261494|NCT00030901|P1|Participant Flow|All Patients|
1261495|NCT00030901|O2|Outcome|Placebo|Patients receive oral placebo once daily for 3 years
1261496|NCT00030901|O1|Outcome|Selenium|Patients receive oral selenium once daily for 3 years
1261498|NCT00030901|O1|Outcome|Selenium|Patients receive oral selenium once daily for 3 years
1261499|NCT00030901|E2|Reported Event|Placebo|Patients receive oral placebo once daily for 3 years
1261500|NCT00030901|E1|Reported Event|Selenium|Patients receive oral selenium once daily for 3 years
1261501|NCT00030823|B1|Baseline|Vaccine|Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.
1261502|NCT00030823|P1|Participant Flow|Vaccine|Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.
1261503|NCT00030823|O1|Outcome|Vaccine|Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.
1261504|NCT00030823|E1|Reported Event|Vaccine|Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.
1261505|NCT00030147|B5|Baseline|Total|Total of all reporting groups
1261506|NCT00030147|B4|Baseline|Rimostil|Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
1261507|NCT00030147|B3|Baseline|Raloxifene|Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
1261508|NCT00030147|B2|Baseline|Placebo|Placebo skin patch and placebo tablets for eight weeks
1261509|NCT00030147|B1|Baseline|Estradiol|Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
1261510|NCT00030147|P4|Participant Flow|Rimostil|Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
1261511|NCT00030147|P3|Participant Flow|Raloxifene|Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
1261512|NCT00030147|P2|Participant Flow|Placebo|Placebo skin patch and placebo tablets for eight weeks
1261513|NCT00030147|P1|Participant Flow|Estradiol|Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
1261514|NCT00030147|O4|Outcome|Rimostil|Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
1261515|NCT00030147|O3|Outcome|Raloxifene|Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
1261516|NCT00030147|O2|Outcome|Placebo|Placebo skin patch and placebo tablets for eight weeks
1261517|NCT00030147|O1|Outcome|Estradiol|Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
1261518|NCT00030147|O4|Outcome|Rimostil|Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
1261519|NCT00030147|O3|Outcome|Raloxifene|Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
1261520|NCT00030147|O2|Outcome|Placebo|Placebo skin patch and placebo tablets for eight weeks
1261521|NCT00030147|O1|Outcome|Estradiol|Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
1261522|NCT00030147|E4|Reported Event|Rimostil|Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
1261523|NCT00030147|E3|Reported Event|Raloxifene|Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
1261524|NCT00030147|E2|Reported Event|Placebo|Placebo skin patch and placebo tablets for eight weeks
1261525|NCT00030147|E1|Reported Event|Estradiol|Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
1261526|NCT00029536|B5|Baseline|Total|Total of all reporting groups
1261527|NCT00029536|B4|Baseline|Noncatamenial Epilespy: Placebo Lozenges|Subjects without catamenial epilepsy received matched placebo lozenges
1261528|NCT00029536|B3|Baseline|Noncatamenial Epilespy:Progesterone Lozenges|Subjects without catamenial epilepsy received 200 mg progesterone lozenges
1261529|NCT00029536|B2|Baseline|Catamenial Epilepsy: Placebo Lozenges|Subjects with catamenial epilepsy received matched placebo lozenges
1261530|NCT00029536|B1|Baseline|Catamenial Epilepsy: Progesterone Lozenges|Subjects with catamenial epilepsy received 200 mg progesterone lozenges
1261531|NCT00029536|P4|Participant Flow|Noncatamenial Epilespy: Placebo Lozenges|Subjects without catamenial epilepsy received matched placebo lozenges
1261532|NCT00029536|P3|Participant Flow|Noncatamenial Epilespy:Progesterone Lozenges|Subjects without catamenial epilepsy received 200 mg progesterone lozenges
1261533|NCT00029536|P2|Participant Flow|Catamenial Epilepsy: Placebo Lozenges|Subjects with catamenial epilepsy received matched placebo lozenges
1261534|NCT00029536|P1|Participant Flow|Catamenial Epilepsy: Progesterone Lozenges|Subjects with catamenial epilepsy received 200 mg progesterone lozenges
1261535|NCT00029536|O2|Outcome|Placebo Lozenges|Subjects with catamenial and non-Catamenial epilepsy who received matched placebo lozenges
1261536|NCT00029536|O1|Outcome|Progesterone Lozenges|Subjects with catamenial and Non-Catamential epilepsy who received 200 mg progesterone lozenges
1261537|NCT00029536|O4|Outcome|Noncatamenial Epilespy: Placebo Lozenges|Subjects without catamenial epilepsy received matched placebo lozenges
1261538|NCT00029536|O3|Outcome|Noncatamenial Epilespy:Progesterone Lozenges|Subjects without catamenial epilepsy received 200 mg progesterone lozenges
1261539|NCT00029536|O2|Outcome|Catamenial Epilepsy: Placebo Lozenges|Subjects with catamenial epilepsy received matched placebo lozenges
1261540|NCT00029536|O1|Outcome|Catamenial Epilepsy: Progesterone Lozenges|Subjects with catamenial epilepsy received 200 mg progesterone lozenges
1261541|NCT00029536|O4|Outcome|Noncatamenial Epilespy: Placebo Lozenges|Subjects without catamenial epilepsy received matched placebo lozenges
1261542|NCT00029536|O3|Outcome|Noncatamenial Epilespy:Progesterone Lozenges|Subjects without catamenial epilepsy received 200 mg progesterone lozenges
1261543|NCT00029536|O2|Outcome|Catamenial Epilepsy: Placebo Lozenges|Subjects with catamenial epilepsy received matched placebo lozenges
1261544|NCT00029536|O1|Outcome|Catamenial Epilepsy: Progesterone Lozenges|Subjects with catamenial epilepsy received 200 mg progesterone lozenges
1261545|NCT00029536|O4|Outcome|Noncatamenial Epilespy: Placebo Lozenges|Subjects without catamenial epilepsy received matched placebo lozenges
1261546|NCT00029536|O3|Outcome|Noncatamenial Epilespy:Progesterone Lozenges|Subjects without catamenial epilepsy received 200 mg progesterone lozenges
1261547|NCT00029536|O2|Outcome|Catamenial Epilepsy: Placebo Lozenges|Subjects with catamenial epilepsy received matched placebo lozenges
1261548|NCT00029536|O1|Outcome|Catamenial Epilepsy: Progesterone Lozenges|Subjects with catamenial epilepsy received 200 mg progesterone lozenges
1261549|NCT00029536|O4|Outcome|Noncatamenial Epilespy: Placebo Lozenges|Subjects without catamenial epilepsy received matched placebo lozenges
1261550|NCT00029536|O3|Outcome|Noncatamenial Epilespy:Progesterone Lozenges|Subjects without catamenial epilepsy received 200 mg progesterone lozenges
1261551|NCT00029536|O2|Outcome|Catamenial Epilepsy: Placebo Lozenges|Subjects with catamenial epilepsy received matched placebo lozenges
1261552|NCT00029536|O1|Outcome|Catamenial Epilepsy: Progesterone Lozenges|Subjects with catamenial epilepsy received 200 mg progesterone lozenges
1261553|NCT00029536|E4|Reported Event|Noncatamenial Epilespy: Placebo Lozenges|Subjects without catamenial epilepsy received matched placebo lozenges
1261554|NCT00029536|E3|Reported Event|Noncatamenial Epilespy:Progesterone Lozenges|Subjects without catamenial epilepsy received 200 mg progesterone lozenges
1261555|NCT00029536|E2|Reported Event|Catamenial Epilepsy: Placebo Lozenges|Subjects with catamenial epilepsy received matched placebo lozenges
1261556|NCT00029536|E1|Reported Event|Catamenial Epilepsy: Progesterone Lozenges|Subjects with catamenial epilepsy received 200 mg progesterone lozenges
1261557|NCT00029172|B1|Baseline|Case Management|
1261558|NCT00029172|P1|Participant Flow|Case Management|
1261559|NCT00029172|O1|Outcome|Case Management|
1261560|NCT00029172|E1|Reported Event|Case Management|
1261561|NCT00029146|B3|Baseline|Total|Total of all reporting groups
1261562|NCT00029146|B2|Baseline|Non-surgical Group|Receives best current practice medical therapy
1261563|NCT00029146|B1|Baseline|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
1261564|NCT00029146|P2|Participant Flow|Non-surgical Group|Receives best current practice medical therapy
1261565|NCT00029146|P1|Participant Flow|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
1261566|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
1261567|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
1261568|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
1261569|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
1261570|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
1261571|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
1261572|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
1261573|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
1261574|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
1261575|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
1261576|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
1261577|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
1261578|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
1261579|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
1261580|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
1261581|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
1261582|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
1261583|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
1261584|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
1261585|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
1261586|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
1261587|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
1261588|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
1261589|NCT00029146|E2|Reported Event|Non-surgical Group|Receives best current practice medical therapy
1261590|NCT00029146|E1|Reported Event|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
1261591|NCT00029107|B3|Baseline|Total|Total of all reporting groups
1261592|NCT00029107|B2|Baseline|Standard Therapy|Receives standard therapy. After 6 months, they are eligibile to cross over and receive four weekly infusions of rituximab.
1261593|NCT00029107|B1|Baseline|Immediate Treatment|Patients receive treatment with four weekly infusions of rituximab immediately following randomization.
1261594|NCT00029107|P2|Participant Flow|Standard Therapy|Receives standard therapy. After 6 months, they are eligibile to cross over and receive four weekly infusions of rituximab.
1261595|NCT00029107|P1|Participant Flow|Immediate Treatment|Patients receive treatment with four weekly infusions of rituximab immediately following randomization.
1261596|NCT00029107|O2|Outcome|Standard Therapy|Receives standard therapy. After 6 months, they are eligibile to cross over and receive four weekly infusions of rituximab.
1261597|NCT00029107|O1|Outcome|Immediate Treatment|Patients receive treatment with four weekly infusions of rituximab immediately following randomization.
1261598|NCT00029107|E2|Reported Event|Standard Therapy|Receives standard therapy. After 6 months, they are eligibile to cross over and receive four weekly infusions of rituximab.
1261740|NCT00026312|P2|Participant Flow|Regimen B|Regimen B – RA + Immunotherapy
1261599|NCT00029107|E1|Reported Event|Immediate Treatment|Patients receive treatment with four weekly infusions of rituximab immediately following randomization.
1261600|NCT00028769|B1|Baseline|CAD + Chemo|Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m^2 given intravenously within 1 hour on day 2 of each cycle)
1261601|NCT00028769|P1|Participant Flow|CAD + Chemo|Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m^2 given intravenously within 1 hour on day 2 of each cycle)
1261602|NCT00028769|O1|Outcome|CAD + Chemo|Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m^2 given intravenously within 1 hour on day 2 of each cycle)
1261603|NCT00028769|O1|Outcome|CAD + Chemo|Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m^2 given intravenously within 1 hour on day 2 of each cycle)
1261604|NCT00028769|O1|Outcome|CAD + Chemo|Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m^2 given intravenously within 1 hour on day 2 of each cycle)
1261605|NCT00028769|E1|Reported Event|CAD + Chemo|Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m^2 given intravenously within 1 hour on day 2 of each cycle)
1261606|NCT00028262|B1|Baseline|Drug Cystagon and N-acetylcysteine|
1261607|NCT00028262|P1|Participant Flow|Drug Cystagon and N-acetylcysteine|
1261608|NCT00028262|O1|Outcome|Drug Cystagon and N-acetylcysteine|
1261609|NCT00028262|E1|Reported Event|Drug Cystagon and N-acetylcysteine|
1261610|NCT00028093|B3|Baseline|Total|Total of all reporting groups
1261611|NCT00028093|B2|Baseline|Peginterferon Alone|peginterferon-alpha 2a, 180 ug subcutaneous once weekly for the first 4 weeks of therapy, after which peginterferon was continued at the same dose and weight-based oral ribavirin was added and continued for an additional 44 weeks.
1261612|NCT00028093|B1|Baseline|Peginterferon+Ribavirin|peginterferon alpha-2a, 180 ug subcutaneous once weekly and weight-based oral ribavirin (1000 mg daily for patients less than 75 kg and 1200 mg daily for patients greater than 75 kg) for 48 weeks
1261613|NCT00028093|P2|Participant Flow|Peginterferon Alone|peginterferon-alpha 2a, 180 ug subcutaneous once weekly for the first 4 weeks of therapy, after which peginterferon was continued at the same dose and weight-based oral ribavirin was added and continued for an additional 44 weeks.
1261614|NCT00028093|P1|Participant Flow|Peginterferon+Ribavirin|peginterferon alpha-2a, 180 ug subcutaneous once weekly and weight-based oral ribavirin (1000 mg daily for patients less than 75 kg and 1200 mg daily for patients greater than 75 kg) for 48 weeks
1261615|NCT00028093|O2|Outcome|Peginterferon|
1261616|NCT00028093|O1|Outcome|Peginterferon+Ribavirin|
1261617|NCT00028093|E2|Reported Event|Peginterferon Alone|peginterferon-alpha 2a, 180 ug subcutaneous once weekly for the first 4 weeks of therapy, after which peginterferon was continued at the same dose and weight-based oral ribavirin was added and continued for an additional 44 weeks.
1261618|NCT00028093|E1|Reported Event|Peginterferon+Ribavirin|peginterferon alpha-2a, 180 ug subcutaneous once weekly and weight-based oral ribavirin (1000 mg daily for patients less than 75 kg and 1200 mg daily for patients greater than 75 kg) for 48 weeks
1261619|NCT00028002|B1|Baseline|Imatinib Mesylate|Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.
1261620|NCT00028002|P1|Participant Flow|Imatinib Mesylate|Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.
1261621|NCT00028002|O1|Outcome|Imatinib Mesylate|Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.
1261741|NCT00026312|P1|Participant Flow|Regimen A|Randomized to Regimen A – RA Only
1261742|NCT00026312|O1|Outcome|Regimen B|Non-randomly assigned to Regimen B after halting of randomization, excluding patients with persistent disease
1261622|NCT00028002|E1|Reported Event|Imatinib Mesylate|Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.
1261623|NCT00027846|B4|Baseline|Total|Total of all reporting groups
1261624|NCT00027846|B3|Baseline|Sub-Total Resection Any Histology or Location (STR) (Group 3)|"Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy.~filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously.~carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient"
1261625|NCT00027846|B2|Baseline|Radiation (Group 2)|"Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.~radiation therapy: Given once daily 5 days a week for 6-6½ weeks"
1261626|NCT00027846|B1|Baseline|GTR1 Differentiated Histology Supratentorial (Group 1)|Patients undergo observation.
1261627|NCT00027846|P3|Participant Flow|Sub-Total Resection Any Histology or Location (STR) (Group 3)|"Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy.~filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously.~carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient"
1261628|NCT00027846|P2|Participant Flow|Radiation (Group 2)|"Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.~radiation therapy: Given once daily 5 days a week for 6-6½ weeks"
1261629|NCT00027846|P1|Participant Flow|GTR1 Differentiated Histology Supratentorial (Group 1)|Patients undergo observation.
1261630|NCT00027846|O3|Outcome|Sub-Total Resection Any Histology or Location (STR) (Group 3)|"Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy.~filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously.~carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient"
1261631|NCT00027846|O2|Outcome|Radiation (Group 2)|"Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.~radiation therapy: Given once daily 5 days a week for 6-6½ weeks"
1261632|NCT00027846|O1|Outcome|GTR1 Differentiated Histology Supratentorial (Group 1)|Patients undergo observation.
1261633|NCT00027846|O2|Outcome|Anaplastic Ependymoma|Anaplastic ependymoma:tumor pathology by central review.
1261634|NCT00027846|O1|Outcome|Differentiated Ependymoma|Differentiated ependymoma:tumor pathology by central review.
1261635|NCT00027846|O2|Outcome|Anaplastic Ependymoma|Anaplastic ependymoma:tumor pathology by central review.
1261636|NCT00027846|O1|Outcome|Differentiated Ependymoma|Differentiated ependymoma:tumor pathology by central review.
1261637|NCT00027846|O1|Outcome|Sub-Total Resection Any Histology or Location (STR) (Group 3)|"Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy.~filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously.~carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient"
1261660|NCT00027378|O2|Outcome|Placebo Plus Treatment as Usual (TAU)|Subjects were treated with placbo plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
1261661|NCT00027378|O1|Outcome|Fluoxetine Plus Treatment As Usual (TAU)|Subjects were treated with the medication fluoxetine (15 mg to 30 mg) plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
1261696|NCT00027027|O4|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261638|NCT00027846|O3|Outcome|Sub-Total Resection Any Histology or Location (STR) (Group 3)|"Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy.~filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously.~carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient"
1261639|NCT00027846|O2|Outcome|Radiation (Group 2)|"Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.~radiation therapy: Given once daily 5 days a week for 6-6½ weeks"
1261640|NCT00027846|O1|Outcome|GTR1 Differentiated Histology Supratentorial (Group 1)|Patients undergo observation.
1261641|NCT00027846|O3|Outcome|Sub-Total Resection Any Histology or Location (STR) (Group 3)|"Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy.~filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously.~carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient"
1261642|NCT00027846|O2|Outcome|Radiation (Group 2)|"Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.~radiation therapy: Given once daily 5 days a week for 6-6½ weeks"
1261643|NCT00027846|O1|Outcome|GTR1 Differentiated Histology Supratentorial (Group 1)|Patients undergo observation.
1261644|NCT00027846|E2|Reported Event|Sub-Total Resection Any Histology or Location (STR) (Group 3)|"Patients receive initial course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and cyclophosphamide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously or IV beginning on day 3 and continuing until blood counts recover. Patients then receive a second course of chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 1 hour on day 1, and oral etoposide on days 1-21. After completion of chemotherapy, patients are evaluated for second therapeutic conventional surgery. Patients who have unresectable disease undergo conformal radiation therapy. Patients who have resectable disease undergo second surgery followed by conformal radiotherapy.~filgrastim: Given IV or SC (5mcg/kg/day) start on Day 3 and continue until ANC >1500/μl given subcutaneously or intravenously.~carboplatin: Given IV (375 mg/m2/day) Day 1 given as an IV infusion over one hour. For patient"
1261645|NCT00027846|E1|Reported Event|Radiation (Group 2)|"Supratentorial Anaplastic Ependymoma (GTR1, GTR2, NTR) and Anaplastic or Differentiated Infratentorial Ependymoma (GTR1, GTR2, NTR) and Supratentorial Differentiated Ependymoma(GTR2, NTR). Patients undergo conformal radiation therapy to the brain once daily 5 days a week for 6-6½ weeks.~radiation therapy: Given once daily 5 days a week for 6-6½ weeks"
1261646|NCT00027560|B1|Baseline|TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES|This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
1261647|NCT00027560|P1|Participant Flow|TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES|This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
1261648|NCT00027560|O1|Outcome|Unrelated and Mismatched Related Patients|
1261649|NCT00027560|O1|Outcome|Matched Related Patients|
1261650|NCT00027560|O1|Outcome|Unrelated and Mismatched Related Patients|
1261651|NCT00027560|O1|Outcome|Matched Related Patients|
1261652|NCT00027560|O1|Outcome|TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES|This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
1261653|NCT00027560|O1|Outcome|TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES|This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
1261654|NCT00027560|E1|Reported Event|TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES|This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
1261655|NCT00027378|B3|Baseline|Total|Total of all reporting groups
1261656|NCT00027378|B2|Baseline|Placebo Plus Treatment as Usual (TAU)|Subjects were treated with placbo plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
1261657|NCT00027378|B1|Baseline|Fluoxetine Plus Treatment As Usual (TAU)|Subjects were treated with the medication fluoxetine (15 mg to 30 mg) plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
1261658|NCT00027378|P2|Participant Flow|Placebo Plus Treatment as Usual (TAU)|Subjects were treated with placbo plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
1261659|NCT00027378|P1|Participant Flow|Fluoxetine Plus Treatment As Usual (TAU)|Subjects were treated with the medication fluoxetine (15 mg to 30 mg) plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
1261737|NCT00026312|B3|Baseline|Total|Total of all reporting groups
1261662|NCT00027378|O2|Outcome|Placebo Plus Treatment as Usual (TAU)|Subjects were treated with placbo plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
1261663|NCT00027378|O1|Outcome|Fluoxetine Plus Treatment As Usual (TAU)|Subjects were treated with the medication fluoxetine (15 mg to 30 mg) plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
1261664|NCT00027378|E2|Reported Event|Placebo Plus Treatment as Usual (TAU)|Subjects were treated with placbo plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
1261665|NCT00027378|E1|Reported Event|Fluoxetine Plus Treatment As Usual (TAU)|Subjects were treated with the medication fluoxetine (15 mg to 30 mg) plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
1261666|NCT00027027|B6|Baseline|Total|Total of all reporting groups
1261667|NCT00027027|B5|Baseline|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261668|NCT00027027|B4|Baseline|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261669|NCT00027027|B3|Baseline|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261670|NCT00027027|B2|Baseline|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261671|NCT00027027|B1|Baseline|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261672|NCT00027027|P5|Participant Flow|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261673|NCT00027027|P4|Participant Flow|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261674|NCT00027027|P3|Participant Flow|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261675|NCT00027027|P2|Participant Flow|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261676|NCT00027027|P1|Participant Flow|rhuMAb 2C4: 0.5 Milligrams Per Kilogram (mg/kg)|Recombinant Humanized Antibody to human epidermal growth factor receptor 2 (rhuMAb 2C4) 0.5 mg/kg was administered once every 3 weeks as an intravenous (IV) infusion until progressive disease (PD) or unacceptable toxicity occurred for up to a maximum of 1 year.
1261677|NCT00027027|O5|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261678|NCT00027027|O4|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261679|NCT00027027|O3|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261680|NCT00027027|O2|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261681|NCT00027027|O1|Outcome|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261682|NCT00027027|O4|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261683|NCT00027027|O3|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261684|NCT00027027|O2|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261685|NCT00027027|O1|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261686|NCT00027027|O4|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261687|NCT00027027|O3|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261688|NCT00027027|O2|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261689|NCT00027027|O1|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261690|NCT00027027|O5|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261691|NCT00027027|O4|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261692|NCT00027027|O3|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261693|NCT00027027|O2|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261694|NCT00027027|O1|Outcome|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261695|NCT00027027|O5|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261697|NCT00027027|O3|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261698|NCT00027027|O2|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261699|NCT00027027|O1|Outcome|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261700|NCT00027027|O5|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261701|NCT00027027|O4|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261702|NCT00027027|O3|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261703|NCT00027027|O2|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261704|NCT00027027|O1|Outcome|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261705|NCT00027027|O5|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261706|NCT00027027|O4|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261707|NCT00027027|O3|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261708|NCT00027027|O2|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261709|NCT00027027|O1|Outcome|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261710|NCT00027027|O5|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261711|NCT00027027|O4|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261712|NCT00027027|O3|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261713|NCT00027027|O2|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261714|NCT00027027|O1|Outcome|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261715|NCT00027027|E5|Reported Event|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261716|NCT00027027|E4|Reported Event|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261717|NCT00027027|E3|Reported Event|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261718|NCT00027027|E2|Reported Event|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261719|NCT00027027|E1|Reported Event|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
1261720|NCT00026494|B5|Baseline|Total|Total of all reporting groups
1261721|NCT00026494|B4|Baseline|30mg/m2 - Vinorelbine|Temozolomide and 30mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
1261722|NCT00026494|B3|Baseline|25mg/m2 - Vinorelbine|Temozolomide and 25mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
1261723|NCT00026494|B2|Baseline|20mg/m2 - Vinorelbine|Temozolomide and 20mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
1261724|NCT00026494|B1|Baseline|15mg/m2 - Vinorelbine|Temozolomide and 15mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
1261725|NCT00026494|P4|Participant Flow|30mg/m2 - Vinorelbine|Temozolomide and 30mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
1261726|NCT00026494|P3|Participant Flow|25mg/m2 - Vinorelbine|Temozolomide and 25mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
1261727|NCT00026494|P2|Participant Flow|20mg/m2 - Vinorelbine|Temozolomide and 20mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
1261728|NCT00026494|P1|Participant Flow|15mg/m2 - Vinorelbine|Temozolomide and 15mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
1261729|NCT00026494|O4|Outcome|30mg/m2 - Vinorelbine|Temozolomide and 30mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
1261730|NCT00026494|O3|Outcome|25mg/m2 - Vinorelbine|Temozolomide and 25mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
1261731|NCT00026494|O2|Outcome|20mg/m2 - Vinorelbine|Temozolomide and 20mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
1261732|NCT00026494|O1|Outcome|15mg/m2 - Vinorelbine|Temozolomide and 15mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
1261733|NCT00026494|E4|Reported Event|30mg/m2 - Vinorelbine|Temozolomide and 30mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
1261734|NCT00026494|E3|Reported Event|25mg/m2 - Vinorelbine|Temozolomide and 25mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
1261735|NCT00026494|E2|Reported Event|20mg/m2 - Vinorelbine|Temozolomide and 20mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
1261736|NCT00026494|E1|Reported Event|15mg/m2 - Vinorelbine|Temozolomide and 15mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
1261743|NCT00026312|O2|Outcome|Regimen B|Randomized to Regimen B - RA + Immunotherapy
1261744|NCT00026312|O1|Outcome|Regimen A|Randomized to Regimen A - RA Only
1261745|NCT00026312|O1|Outcome|Regimen B|Regimen B- RA + Immunotherapy
1261746|NCT00026312|O2|Outcome|Regimen B|Patients that received RA + Immunotherapy before halting of randomization
1261747|NCT00026312|O1|Outcome|Regimen A|Randomized to Regimen A - RA Only
1261748|NCT00026312|O1|Outcome|Regimen B|Non-randomly assigned to Regimen B after halting of randomization, excluding patients with persistent disease
1261749|NCT00026312|O2|Outcome|Regimen B|Regimen B - RA + Immunotherapy
1261750|NCT00026312|O1|Outcome|Regimen A|Randomized to Regimen A - RA Only
1261751|NCT00026312|O2|Outcome|Regimen B|Randomized to Regimen B - RA + Immunotherapy
1261752|NCT00026312|O1|Outcome|Regimen A|Randomized to Regimen A - RA Only
1261753|NCT00026312|E2|Reported Event|Regimen B|Regimen B – RA + Immunotherapy
1261754|NCT00026312|E1|Reported Event|Regimen A|Randomized to Regimen A - RA Only
1261755|NCT00026221|B4|Baseline|Total|Total of all reporting groups
1261756|NCT00026221|B3|Baseline|Arm III (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
1261757|NCT00026221|B2|Baseline|Arm II (Monoclonal Antibody)|"Patients receive bevacizumab as in arm I.~Bevacizumab: Given IV"
1261758|NCT00026221|B1|Baseline|Arm I (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
1261759|NCT00026221|P3|Participant Flow|Arm III (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
1261760|NCT00026221|P2|Participant Flow|Arm II: Bevacizumab Alone|"Patients receive bevacizumab as in arm I.~Bevacizumab: Given IV"
1261761|NCT00026221|P1|Participant Flow|Arm I: Bevacizumab + Iinterferon-alpha-2b|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
1261762|NCT00026221|O3|Outcome|Arm III (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
1261763|NCT00026221|O2|Outcome|Arm II: Bevacizumab Alone|"Patients receive bevacizumab as in arm I.~Bevacizumab: Given IV"
1261764|NCT00026221|O1|Outcome|Arm I: Bevacizumab + Iinterferon-alpha-2b|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
1261765|NCT00026221|O3|Outcome|Arm III (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
1261766|NCT00026221|O2|Outcome|Arm II: Bevacizumab Alone|"Patients receive bevacizumab as in arm I.~Bevacizumab: Given IV"
1261767|NCT00026221|O1|Outcome|Arm I: Bevacizumab + Iinterferon-alpha-2b|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
1261768|NCT00026221|O3|Outcome|Arm III (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
1261769|NCT00026221|O2|Outcome|Arm II: Bevacizumab Alone|"Patients receive bevacizumab as in arm I.~Bevacizumab: Given IV"
1261770|NCT00026221|O1|Outcome|Arm I: Bevacizumab + Iinterferon-alpha-2b|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
1261771|NCT00026221|O3|Outcome|Arm III (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
1261772|NCT00026221|O2|Outcome|Arm II: Bevacizumab Alone|"Patients receive bevacizumab as in arm I.~Bevacizumab: Given IV"
1261773|NCT00026221|O1|Outcome|Arm I: Bevacizumab + Iinterferon-alpha-2b|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
1261774|NCT00026221|E3|Reported Event|Arm III (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
1261775|NCT00026221|E2|Reported Event|Arm II: Bevacizumab Alone|"Patients receive bevacizumab as in arm I.~Bevacizumab: Given IV"
1261776|NCT00026221|E1|Reported Event|Arm I: Bevacizumab + Iinterferon-alpha-2b|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
1261777|NCT00025883|B3|Baseline|Total|Total of all reporting groups
1261778|NCT00025883|B2|Baseline|Metreleptin With Patial Lipodystrophy|patients with partial lipodystrophy with subcutaneous metreleptin injection (0.06-0.24 mg/kg/day)
1261779|NCT00025883|B1|Baseline|Metreleptin With Generalized Lipodystrophy|patients with generalized lipodystrophy with subcutaneous metreleptin injection (0.06-0.24 mg/kg/day)
1261780|NCT00025883|P1|Participant Flow|Metreleptin|subcutaneous metreleptin injections in one to two daily doses ranging from 0.06 to 0.24 mg/kg/day.
1261781|NCT00025883|O2|Outcome|Partial Lipodystrophy (PLD)|patients with partial lipodystrophy (PLD) with initiation of subcutaneous metreleptin injection (0.06-0.24 mg/kg/day)
1261782|NCT00025883|O1|Outcome|Generalized Lipodystrophy (GLD)|patients with generalized lipodystrophy (GLD) with initiation of subcutaneous metreleptin injection (0.06-0.24 mg/kg/day)
1262328|NCT00011986|P1|Participant Flow|Carbo/Taxol|Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles
1261783|NCT00025883|O2|Outcome|Partial Lipodystrophy (PLD)|patients with partial lipodystrophy (PLD) with initiation of subcutaneous metreleptin injection (0.06-0.24 mg/kg/day)
1261784|NCT00025883|O1|Outcome|Generalized Lipodystrophy (GLD)|patients with generalized lipodystrophy (GLD) with initiation of subcutaneous metreleptin injection (0.06-0.24 mg/kg/day)
1261785|NCT00025883|E1|Reported Event|Metreleptin|subcutaneous metreleptin injection (0.06-0.24 mg/kg/day)
1261786|NCT00025662|B1|Baseline|RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants|Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
1261787|NCT00025662|P1|Participant Flow|"RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants"|"Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults"
1261788|NCT00025662|O1|Outcome|RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants|Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
1261789|NCT00025662|O1|Outcome|RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants|Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
1261790|NCT00025662|O1|Outcome|RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants|Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
1261791|NCT00025662|O1|Outcome|RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants|Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
1261792|NCT00025662|O1|Outcome|RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants|Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
1261793|NCT00025662|E1|Reported Event|RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants|Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
1261794|NCT00025506|B1|Baseline|Thalidomide|Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
1261795|NCT00025506|P1|Participant Flow|Thalidomide|Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
1261796|NCT00025506|O1|Outcome|Thalidomide|Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
1261797|NCT00025506|O1|Outcome|Thalidomide|Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
1261798|NCT00025506|O1|Outcome|Thalidomide|Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
1261799|NCT00025506|E1|Reported Event|Thalidomide|Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
1261800|NCT00025259|B8|Baseline|Total|Total of all reporting groups
1261801|NCT00025259|B7|Baseline|Arm VII (SER [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive 2 additional courses of ABVE-PC. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
1261802|NCT00025259|B6|Baseline|Arm VI (SER [DECA, ABVE-PC, IFRT])|"Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, & cytarabine IV over 3 hours on days 1-2. Patients receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 & 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 & G-CSF SC beginning on day 3 & continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive 2 additional courses of ABVE-PC chemotherapy. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.~Bleomycin Sulfate: Given IV or SC~Cisplatin: Given IV~Cyclophosphamide: Given IV~Cytarabine: Given IV~Dexamethasone: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Pre"
1261856|NCT00025155|P1|Participant Flow|Treatment (Ixabepilone)|Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
1262728|NCT00006392|E4|Reported Event|Vitamin E Alone|Vitamin E + placebo for selenium
1261962|NCT00023309|P1|Participant Flow|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir, with lamivudine of 100 mg daily and adefovir of 10 mg daily
1261803|NCT00025259|B5|Baseline|Arm V (RER With PD)|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients with PD are taken off therapy.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
1261804|NCT00025259|B4|Baseline|Arm IV (RER With Less Than CR [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with VGPR, PR or SD undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
1261805|NCT00025259|B3|Baseline|Arm III (RER With CR [ABVE-PC])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR are randomized to receive no further treatment.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
1261806|NCT00025259|B2|Baseline|Arm II (RER With CR [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR undergo IFRT approximately 3 weeks after the last day of ABVE course 4.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
1261807|NCT00025259|B1|Baseline|Arm I (Patients Off-therapy Before Callback-Induction Only)|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
1261808|NCT00025259|P7|Participant Flow|Arm VII (SER [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive 2 additional courses of ABVE-PC. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
1261809|NCT00025259|P6|Participant Flow|Arm VI (SER [DECA, ABVE-PC, IFRT])|"Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, & cytarabine IV over 3 hours on days 1-2. Patients receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 & 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 & G-CSF SC beginning on day 3 & continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive 2 additional courses of ABVE-PC chemotherapy. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.~Bleomycin Sulfate: Given IV or SC~Cisplatin: Given IV~Cyclophosphamide: Given IV~Cytarabine: Given IV~Dexamethasone: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Pre"
1261810|NCT00025259|P5|Participant Flow|Arm V (RER With PD)|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients with PD are taken off therapy.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
1261857|NCT00025155|O1|Outcome|Treatment (Ixabepilone)|Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
1261858|NCT00025155|O1|Outcome|Treatment (Ixabepilone)|Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
1261811|NCT00025259|P4|Participant Flow|Arm IV (RER With Less Than CR [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with VGPR, PR or SD undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
1261812|NCT00025259|P3|Participant Flow|Arm III (RER With CR [ABVE-PC])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR are randomized to receive no further treatment.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
1261813|NCT00025259|P2|Participant Flow|Arm II (RER With CR [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR undergo IFRT approximately 3 weeks after the last day of ABVE course 4.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
1261814|NCT00025259|P1|Participant Flow|Arm I (Patients Off-therapy Before Callback-Induction Only)|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
1261815|NCT00025259|O6|Outcome|Arm VII (SER [ABVE-PC, IFRT])|SER - randomized to ABVE-PCX2 + IFRT
1261816|NCT00025259|O5|Outcome|Arm VI (SER [DECA, ABVE-PC, IFRT])|SER - randomized to DECAX2 + ABVE-PCX2 + IFRT
1261817|NCT00025259|O4|Outcome|Arm IV (RER With Less Than CR [ABVE-PC, IFRT])|RER with less than Complete Response - IFRT
1261818|NCT00025259|O3|Outcome|Arm III (RER With CR [ABVE-PC])|RER with Complete Response - no IFRT ( Reduced Therapy Arm)
1261819|NCT00025259|O2|Outcome|Arm II (RER With CR [ABVE-PC, IFRT])|RER with Complete Response - IFRT (Standard Arm)
1261820|NCT00025259|O1|Outcome|Arm I (Patients Off-therapy Before Callback-Induction Only)|All patients-off therapy before callback-Induction only
1261821|NCT00025259|O7|Outcome|Arm VII (SER [ABVE-PC, IFRT])|SER - randomized to ABVE-PCX2 + IFRT
1261822|NCT00025259|O6|Outcome|Arm VI (SER [DECA, ABVE-PC, IFRT])|SER - randomized to DECAX2 + ABVE-PCX2 + IFRT
1261823|NCT00025259|O5|Outcome|Arm V (RER With PD)|RER with Progressive Disease - Off Therapy
1261824|NCT00025259|O4|Outcome|Arm IV (RER With Less Than CR [ABVE-PC, IFRT])|RER with less than Complete Response - IFRT
1261825|NCT00025259|O3|Outcome|Arm III (RER With CR [ABVE-PC])|RER with Complete Response - no IFRT ( Reduced Therapy Arm)
1261826|NCT00025259|O2|Outcome|Arm II (RER With CR [ABVE-PC, IFRT])|RER with Complete Response - IFRT (Standard Arm)
1261827|NCT00025259|O1|Outcome|Arm I (Patients Off-therapy Before Callback-Induction Only)|All patients-off therapy before callback-Induction only
1261828|NCT00025259|O7|Outcome|Arm VII (SER [ABVE-PC, IFRT])|SER - randomized to ABVE-PCX2 + IFRT
1261829|NCT00025259|O6|Outcome|Arm VI (SER [DECA, ABVE-PC, IFRT])|SER - randomized to DECAX2 + ABVE-PCX2 + IFRT
1261830|NCT00025259|O5|Outcome|Arm V (RER With PD)|RER with Progressive Disease - Off Therapy
1261831|NCT00025259|O4|Outcome|Arm IV (RER With Less Than CR [ABVE-PC, IFRT])|RER with less than Complete Response - IFRT
1261832|NCT00025259|O3|Outcome|Arm III (RER With CR [ABVE-PC])|RER with Complete Response - no IFRT ( Reduced Therapy Arm)
1261833|NCT00025259|O2|Outcome|Arm II (RER With CR [ABVE-PC, IFRT])|RER with Complete Response - IFRT (Standard Arm)
1261834|NCT00025259|O1|Outcome|Arm I (Patients Off-therapy Before Callback-Induction Only)|All patients-off therapy before callback-Induction only
1261835|NCT00025259|O7|Outcome|Arm VII (SER [ABVE-PC, IFRT])|SER - randomized to ABVE-PCX2 + IFRT
1261836|NCT00025259|O6|Outcome|Arm VI (SER [DECA, ABVE-PC, IFRT])|SER - randomized to DECAX2 + ABVE-PCX2 + IFRT
1261837|NCT00025259|O5|Outcome|Arm V (RER With PD)|RER with Progressive Disease - Off Therapy
1261838|NCT00025259|O4|Outcome|Arm IV (RER With Less Than CR [ABVE-PC, IFRT])|RER with less than Complete Response - IFRT
1261839|NCT00025259|O3|Outcome|Arm III (RER With CR [ABVE-PC])|RER with Complete Response - no IFRT (Reduced Therapy Arm)
1261840|NCT00025259|O2|Outcome|Arm II (RER With CR [ABVE-PC, IFRT])|RER with Complete Response - IFRT (Standard Arm)
1261841|NCT00025259|O1|Outcome|Arm I (Patients Off-therapy Before Callback-Induction Only)|All patients-off therapy before callback-Induction only
1261859|NCT00025155|O1|Outcome|Treatment (Ixabepilone)|Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
1262413|NCT00007644|E2|Reported Event|Watchful Waiting|Closely watching, waiting and treating symptoms if and when cancer progresses
1261842|NCT00025259|E7|Reported Event|Arm VII (SER [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive 2 additional courses of ABVE-PC. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
1261843|NCT00025259|E6|Reported Event|Arm VI (SER [DECA, ABVE-PC, IFRT])|"Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, & cytarabine IV over 3 hours on days 1-2. Patients receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 & 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 & G-CSF SC beginning on day 3 & continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive 2 additional courses of ABVE-PC chemotherapy. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.~Bleomycin Sulfate: Given IV or SC~Cisplatin: Given IV~Cyclophosphamide: Given IV~Cytarabine: Given IV~Dexamethasone: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Pre"
1261844|NCT00025259|E5|Reported Event|Arm V (RER With PD)|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients with PD are taken off therapy.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
1261845|NCT00025259|E4|Reported Event|Arm IV (RER With Less Than CR [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with VGPR, PR or SD undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
1261846|NCT00025259|E3|Reported Event|Arm III (RER With CR [ABVE-PC])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR are randomized to receive no further treatment.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
1261847|NCT00025259|E2|Reported Event|Arm II (RER With CR [ABVE-PC, IFRT])|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR undergo IFRT approximately 3 weeks after the last day of ABVE course 4.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Involved-Field Radiation Therapy: Undergo IFRT~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
1261848|NCT00025259|E1|Reported Event|Arm I (Patients Off-therapy Before Callback-Induction Only)|"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease.~Bleomycin Sulfate: Given IV or SC~Cyclophosphamide: Given IV~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Prednisone: Given orally~Vincristine Sulfate Liposome: Given IV"
1261849|NCT00025233|B1|Baseline|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
1261850|NCT00025233|P1|Participant Flow|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
1261851|NCT00025233|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
1261852|NCT00025233|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
1261853|NCT00025233|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
1261854|NCT00025233|E1|Reported Event|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
1261855|NCT00025155|B1|Baseline|Treatment (Ixabepilone)|Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
1261860|NCT00025155|E1|Reported Event|Treatment (Ixabepilone)|Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
1261861|NCT00024258|B1|Baseline|Arsenic Trioxide|"Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2-3 months for 1 year and then annually thereafter."
1261862|NCT00024258|P1|Participant Flow|Arsenic Trioxide|"Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2-3 months for 1 year and then annually thereafter."
1261863|NCT00024258|O1|Outcome|Arsenic Trioxide|"Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2-3 months for 1 year and then annually thereafter."
1261864|NCT00024258|E1|Reported Event|Arsenic Trioxide|"Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2-3 months for 1 year and then annually thereafter."
1261865|NCT00024167|B4|Baseline|Total|Total of all reporting groups
1261866|NCT00024167|B3|Baseline|Induction Treatment + No Strontium-89|Induction treatment option 1: Weeks 1,3,5: Doxorubicin 20 mg/m^2 IV, day 1 and Ketoconazole 400 mg oral 3 x daily, days 1 through 7. Weeks 2,4,6: Vinblastine 4 mg/m^2 IVPB, day 1 and Estramustine 140 mg oral 3 x daily, days 1 through 7. Weeks 7,8: No treatment. Hydrocortisone 10 mg oral 2 x daily will be administered throughout treatment or Induction treatment option 2: Prednisone 5 mg oral 2 x daily, weeks 1-14 and Docetaxel 75 mg/m^2 IVPB over 1 hour, every 3 weeks. Dexamethasone 4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel. Randomization: Doxorubicin 20mg/m^2 IV over 24 hours once weekly for 6 weeks.
1261867|NCT00024167|B2|Baseline|Induction Treatment + Strontium-89|Induction treatment option 1: Weeks 1,3,5: Doxorubicin 20 mg/m^2 IV, day 1 and Ketoconazole 400 mg oral 3 x daily, days 1 through 7. Weeks 2,4,6: Vinblastine 4 mg/m^2 IVPB, day 1 and Estramustine 140 mg oral 3 x daily, days 1 through 7. Weeks 7,8: No treatment. Hydrocortisone 10 mg oral 2 x daily will be administered throughout treatment or Induction treatment option 2: Prednisone 5 mg oral 2 x daily, weeks 1-14 and Docetaxel 75 mg/m^2 IVPB over 1 hour, every 3 weeks. Dexamethasone 4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel. Randomization: Doxorubicin IV over 24 hours once weekly for 6 weeks + Strontium-89 IV once at beginning of chemotherapy.
1261868|NCT00024167|B1|Baseline|Induction Treatment|Induction treatment option 1: Weeks 1,3,5: Doxorubicin 20 mg/m^2 IV, day 1 and Ketoconazole 400 mg oral 3 x daily, days 1 through 7. Weeks 2,4,6: Vinblastine 4 mg/m^2 IVPB, day 1 and Estramustine 140 mg oral 3 x daily, days 1 through 7. Weeks 7,8: No treatment. Hydrocortisone 10 mg oral 2 x daily will be administered throughout treatment or Induction treatment option 2: Prednisone 5 mg oral 2 x daily, weeks 1-14 and Docetaxel 75 mg/m^2 IVPB over 1 hour, every 3 weeks. Dexamethasone 4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel.
1261869|NCT00024167|P2|Participant Flow|Induction Treatment + No Strontium-89|Induction treatment option 1: Weeks 1,3,5: Doxorubicin 20 mg/m^2 IV, day 1 and Ketoconazole 400 mg oral 3 x daily, days 1 through 7. Weeks 2,4,6: Vinblastine 4 mg/m^2 IVPB, day 1 and Estramustine 140 mg oral 3 x daily, days 1 through 7. Weeks 7,8: No treatment. Hydrocortisone 10 mg oral 2 x daily will be administered throughout treatment or Induction treatment option 2: Prednisone 5 mg oral 2 x daily, weeks 1-14 and Docetaxel 75 mg/m^2 IVPB over 1 hour, every 3 weeks. Dexamethasone 4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel. Randomization: Doxorubicin 20mg/m^2 IV over 24 hours once weekly for 6 weeks.
1261870|NCT00024167|P1|Participant Flow|Induction Treatment + Strontium-89|Induction treatment option 1: Weeks 1,3,5: Doxorubicin 20 mg/m^2 IV, day 1 and Ketoconazole 400 mg oral 3 x daily, days 1 through 7. Weeks 2,4,6: Vinblastine 4 mg/m^2 IVPB, day 1 and Estramustine 140 mg oral 3 x daily, days 1 through 7. Weeks 7,8: No treatment. Hydrocortisone 10 mg oral 2 x daily will be administered throughout treatment or Induction treatment option 2: Prednisone 5 mg oral 2 x daily, weeks 1-14 and Docetaxel 75 mg/m^2 IVPB over 1 hour, every 3 weeks. Dexamethasone 4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel. Randomization: Doxorubicin IV over 24 hours once weekly for 6 weeks + Strontium-89 IV once at beginning of chemotherapy.
1261871|NCT00024167|O2|Outcome|Induction Treatment + No Strontium-89|Induction treatment option 1 or induction treatment option 2. Randomization: Doxorubicin 20mg/m^2 IV over 24 hours once weekly for 6 weeks.
1261872|NCT00024167|O1|Outcome|Induction Treatment + Strontium-89|Induction treatment option 1 or induction treatment option 2. Randomization: Doxorubicin IV over 24 hours once weekly for 6 weeks + Strontium-89 IV once at beginning of chemotherapy.
1261873|NCT00024167|O2|Outcome|Induction Treatment + No Strontium-89|Induction treatment option 1 or induction treatment option 2. Randomization: Doxorubicin 20mg/m^2 IV over 24 hours once weekly for 6 weeks.
1261874|NCT00024167|O1|Outcome|Induction Treatment + Strontium-89|Induction treatment option 1 or induction treatment option 2. Randomization: Doxorubicin IV over 24 hours once weekly for 6 weeks + Strontium-89 IV once at beginning of chemotherapy.
1261875|NCT00024167|E3|Reported Event|Induction Treatment + No Strontium-89|Induction treatment option 1 or induction treatment option 2. Randomization: Doxorubicin 20mg/m^2 IV over 24 hours once weekly for 6 weeks.
1261876|NCT00024167|E2|Reported Event|Induction Treatment + Strontium-89|Induction treatment option 1 or induction treatment option 2. Randomization: Doxorubicin IV over 24 hours once weekly for 6 weeks + Strontium-89 IV once at beginning of chemotherapy.
1261877|NCT00024167|E1|Reported Event|Induction Treatment|Induction treatment option 1 or induction treatment option 2.
1261878|NCT00024102|B3|Baseline|Total|Total of all reporting groups
1261879|NCT00024102|B2|Baseline|Capecitabine|Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles.
1261880|NCT00024102|B1|Baseline|Standard Chemotherapy|"Patient/Physician choice of:~CMF: cyclophosphamide (100 mg/m^2 orally days 1-14)+ MTX (40 mg/m^2 by IV days 1 and 8) + 5-FU (600 mg/m^2 by IV days 1 and 8) repeated every 28 days for 6 cycles OR~AC: Cyclophosphamide (600 mg/m^2 by IV on day 1)+ doxorubicin (60 mg/m^2 by IV on day 1) repeated every 21 days for 4 cycles"
1261881|NCT00024102|P2|Participant Flow|Capecitabine|Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles.
1261882|NCT00024102|P1|Participant Flow|Standard Chemotherapy|"Patient/Physician choice of:~CMF: cyclophosphamide (100 mg/m^2 orally days 1-14)+ MTX (40 mg/m^2 by IV days 1 and 8) + 5-FU (600 mg/m^2 by IV days 1 and 8) repeated every 28 days for 6 cycles~OR~AC: Cyclophosphamide (600 mg/m^2 by IV on day 1)+ doxorubicin (60 mg/m^2 by IV on day 1) repeated every 21 days for 4 cycles"
1261883|NCT00024102|O3|Outcome|Capecitabine|Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles
1261884|NCT00024102|O2|Outcome|Standard Chemotherapy (AC)|AC: Cyclophosphamide (600 mg/m^2 by IV on day 1)+ doxorubicin (60 mg/m^2 by IV on day 1) repeated every 21 days for 4 cycles
1261885|NCT00024102|O1|Outcome|Standard Chemotherapy (CMF)|CMF: cyclophosphamide (100 mg/m^2 orally days 1-14)+ MTX (40 mg/m^2 by IV days 1 and 8) + 5-FU (600 mg/m^2 by IV days 1 and 8) repeated every 28 days for 6 cycles
1261886|NCT00024102|O2|Outcome|Capecitabine|Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles.
1261887|NCT00024102|O1|Outcome|Standard Chemotherapy|"Patient/Physician choice of:~CMF: cyclophosphamide (100 mg/m^2 orally days 1-14)+ MTX (40 mg/m^2 by IV days 1 and 8) + 5-FU (600 mg/m^2 by IV days 1 and 8) repeated every 28 days for 6 cycles OR~AC: Cyclophosphamide (600 mg/m^2 by IV on day 1)+ doxorubicin (60 mg/m^2 by IV on day 1) repeated every 21 days for 4 cycles"
1261888|NCT00024102|O2|Outcome|Capecitabine|Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles.
1261889|NCT00024102|O1|Outcome|Standard Chemotherapy|"Patient/Physician choice of:~CMF: cyclophosphamide (100 mg/m^2 orally days 1-14)+ MTX (40 mg/m^2 by IV days 1 and 8) + 5-FU (600 mg/m^2 by IV days 1 and 8) repeated every 28 days for 6 cycles OR~AC: Cyclophosphamide (600 mg/m^2 by IV on day 1)+ doxorubicin (60 mg/m^2 by IV on day 1) repeated every 21 days for 4 cycles"
1261890|NCT00024102|E3|Reported Event|Capecitabine|Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles
1261891|NCT00024102|E2|Reported Event|Standard Chemotherapy (AC)|AC: Cyclophosphamide (600 mg/m^2 by IV on day 1)+ doxorubicin (60 mg/m^2 by IV on day 1) repeated every 21 days for 4 cycles
1261892|NCT00024102|E1|Reported Event|Standard Chemotherapy (CMF)|CMF: cyclophosphamide (100 mg/m^2 orally days 1-14)+ MTX (40 mg/m^2 by IV days 1 and 8) + 5-FU (600 mg/m^2 by IV days 1 and 8) repeated every 28 days for 6 cycles
1261893|NCT00023764|B1|Baseline|PS-341 (Bortezomib)|Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
1261894|NCT00023764|P1|Participant Flow|PS-341 (Bortezomib)|Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
1261895|NCT00023764|O2|Outcome|PS-341 (Bortezomib)-Refractory Patients|Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
1261896|NCT00023764|O1|Outcome|PS-341 (Bortezomib)-Relapsed Patients|Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
1261897|NCT00023764|E1|Reported Event|PS-341 (Bortezomib)|Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
1261898|NCT00023712|B3|Baseline|Total|Total of all reporting groups
1261899|NCT00023712|B2|Baseline|Cohort 2|Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
1261900|NCT00023712|B1|Baseline|Cohort 1|Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
1261901|NCT00023712|P2|Participant Flow|Cohort 2|Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
1261902|NCT00023712|P1|Participant Flow|Cohort 1|Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
1261903|NCT00023712|O2|Outcome|Cohort 2|Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
1261904|NCT00023712|O1|Outcome|Cohort 1|Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
1261905|NCT00023712|O2|Outcome|Cohort 2|Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
1261958|NCT00023309|B3|Baseline|Total|Total of all reporting groups
1261959|NCT00023309|B2|Baseline|Adefovir|Patients to receive adefovir alone
1261963|NCT00023309|O2|Outcome|Adefovir|Patients to receive adefovir alone
1261906|NCT00023712|O1|Outcome|Cohort 1|Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
1261907|NCT00023712|O2|Outcome|Cohort 2|Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
1261908|NCT00023712|O1|Outcome|Cohort 1|Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
1261909|NCT00023712|O2|Outcome|Cohort 2|Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
1261910|NCT00023712|O1|Outcome|Cohort 1|Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
1261911|NCT00023712|E2|Reported Event|Cohort 2|Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
1261912|NCT00023712|E1|Reported Event|Cohort 1|Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
1261913|NCT00023673|B4|Baseline|Total|Total of all reporting groups
1261914|NCT00023673|B3|Baseline|Phase II: 74 Gy/37 fx + Chemotherapy|Phase II: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
1261915|NCT00023673|B2|Baseline|Phase I: 74 Gy/37 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
1261916|NCT00023673|B1|Baseline|Phase I: 75.25 Gy/36 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 75.25 Gy given in 36 fractions (2.15 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
1261917|NCT00023673|P4|Participant Flow|Phase II: 74 Gy/37 fx + Chemotherapy|Phase II: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
1261918|NCT00023673|P3|Participant Flow|Phase I: 70 Gy/35 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 70 Gy given in 35 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
1261919|NCT00023673|P2|Participant Flow|Phase I: 74 Gy/37 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
1261920|NCT00023673|P1|Participant Flow|Phase I: 75.25 Gy/36 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 75.25 Gy given in 36 fractions (2.15 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
1261921|NCT00023673|O1|Outcome|Phase I/II: 74 Gy/37 fx + Chemotherapy|"Phase I/II: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.~carboplatin~paclitaxel~three-dimensional conformal radiation therapy"
1261922|NCT00023673|O2|Outcome|Phase I: 74 Gy/37 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
1261923|NCT00023673|O1|Outcome|Phase I: 75.25 Gy/36 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 75.25 Gy given in 36 fractions (2.15 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
1261924|NCT00023673|E2|Reported Event|Phase I/II: 74 Gy/37 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
1261925|NCT00023673|E1|Reported Event|Phase I: 75.25 Gy/36 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 75.25 Gy given in 36 fractions (2.15 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
1261926|NCT00023452|B3|Baseline|Total|Total of all reporting groups
1261927|NCT00023452|B2|Baseline|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
1261928|NCT00023452|B1|Baseline|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
1261929|NCT00023452|P2|Participant Flow|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV-infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral rifapentine (RPT) tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by Directly Observed Therapy (DOT), defined as a healthcare worker observing ingestion of each dose of RPT and INH.
1261930|NCT00023452|P1|Participant Flow|9INH|Participants who were high-risk tuberculin skin test (TST) reactors (household and other close contacts of active tuberculosis [TB] cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on chest x-ray [CXR], human immunodeficiency virus [HIV] infected participants) self-administered oral isoniazid (INH) tablets (aged greater than or equal to [≥12] years of age received 5 milligrams per kilogram [mg/kg] and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
1261931|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
1261932|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
1261933|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV-infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
1261934|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (aged ≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
1261935|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
1261936|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
1261937|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
1261938|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
1261939|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV-infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
1261960|NCT00023309|B1|Baseline|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir
1261961|NCT00023309|P2|Participant Flow|Adefovir|Patients to receive adefovir alone (10 mg daily).
1261940|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (aged ≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
1261941|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV-infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
1261942|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (aged ≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
1261943|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV-infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
1261944|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (aged ≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
1261945|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV-infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
1261946|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR], HIV infected participants) self-administered oral INH tablets (aged ≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
1261947|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
1261948|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (aged ≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
1261949|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
1261950|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (aged ≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) daily for 9 months (240 to 270 total doses).
1261951|NCT00023452|E2|Reported Event|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
1261952|NCT00023452|E1|Reported Event|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
1261953|NCT00023322|B1|Baseline|Peginterferon Alpha-2a|Patients with hepatitis D virus (HDV) infection are treated with pegylated alpha interferon therapy for 3 years. The dose of the drug is 180 mcg/week.
1261954|NCT00023322|P1|Participant Flow|Peginterferon Alpha-2a|Patients with hepatitis D virus (HDV) infection are treated with pegylated alpha interferon therapy for 3 years. The dose of the drug is 180 mcg/week.
1261955|NCT00023322|O1|Outcome|Peginterferon Alpha-2a|Patients with hepatitis D virus (HDV) infection are treated with pegylated alpha interferon therapy for 3 years. The dose of the drug is 180 mcg/week.
1261956|NCT00023322|O1|Outcome|Peginterferon Alpha-2a|Patients with hepatitis D virus (HDV) infection are treated with pegylated alpha interferon therapy for 3 years. The dose of the drug is 180 mcg/week.
1261957|NCT00023322|E1|Reported Event|Peginterferon Alpha-2a|Patients with hepatitis D virus (HDV) infection are treated with pegylated alpha interferon therapy for 3 years. The dose of the drug is 180 mcg/week.
1261964|NCT00023309|O1|Outcome|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir
1261965|NCT00023309|O2|Outcome|Adefovir|Patients to receive adefovir alone
1261966|NCT00023309|O1|Outcome|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir
1261967|NCT00023309|O2|Outcome|Adefovir|Patients to receive adefovir alone
1261968|NCT00023309|O1|Outcome|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir
1261969|NCT00023309|O2|Outcome|Adefovir|Patients to receive adefovir alone
1261970|NCT00023309|O1|Outcome|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir
1261971|NCT00023309|O2|Outcome|Adefovir|Patients to receive adefovir alone
1261972|NCT00023309|O1|Outcome|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir
1261973|NCT00023309|E2|Reported Event|Adefovir|Patients to receive adefovir alone
1261974|NCT00023309|E1|Reported Event|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir
1261975|NCT00022763|B3|Baseline|Total|Total of all reporting groups
1261976|NCT00022763|B2|Baseline|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
1261977|NCT00022763|B1|Baseline|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
1261978|NCT00022763|P2|Participant Flow|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
1261979|NCT00022763|P1|Participant Flow|Stratum A|Participants of age greater than or equal to (>=) 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
1261980|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
1261981|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
1261982|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
1261983|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
1261984|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
1261985|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
1262063|NCT00022659|B1|Baseline|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
1262038|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
1261986|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
1261987|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
1261988|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
1261989|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
1261990|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
1261991|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
1261992|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
1261993|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
1261994|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
1261995|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
1261996|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
1261997|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
1261998|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
1262173|NCT00019747|E2|Reported Event|Arm 2 - Placebo Once Daily|Patients receive oral placebo once daily.
1261999|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
1262000|NCT00022763|E1|Reported Event|Enfuvirtide|Participants in stratum A (age >= 3 years and less than 12 years received Enfuvirtide Subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose) and in stratum B (age >= 12 years and less than 17 years received Enfuvirtide Subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose).
1262001|NCT00022698|B3|Baseline|Total|Total of all reporting groups
1262002|NCT00022698|B2|Baseline|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
1262003|NCT00022698|B1|Baseline|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
1262004|NCT00022698|P2|Participant Flow|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
1262005|NCT00022698|P1|Participant Flow|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine (Xeloda) 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute intravenous (IV) infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
1262006|NCT00022698|O3|Outcome|Total Participants (Cohort 1 + Cohort 2)|Total of all reporting groups.
1262007|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
1262008|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
1262009|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
1262010|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
1262037|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
1262011|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
1262012|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
1262013|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
1262014|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
1262015|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
1262016|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
1262017|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
1262018|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
1262019|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
1262020|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
1262021|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
1262022|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
1262023|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
1262024|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen:(Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
1262025|NCT00022698|E2|Reported Event|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
1262026|NCT00022698|E1|Reported Event|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
1262027|NCT00022672|B3|Baseline|Total|Total of all reporting groups
1262028|NCT00022672|B2|Baseline|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
1262029|NCT00022672|B1|Baseline|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
1262030|NCT00022672|P2|Participant Flow|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
1262031|NCT00022672|P1|Participant Flow|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
1262032|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
1262033|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
1262034|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
1262035|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
1262036|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
1262414|NCT00007644|E1|Reported Event|Radical Prostatectomy|Surgical removal of the prostate
1262039|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
1262040|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
1262041|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
1262042|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
1262043|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
1262044|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
1262045|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
1262046|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
1262047|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
1262048|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
1262049|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
1262050|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
1262051|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
1262052|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
1262053|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
1262054|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
1262055|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
1262056|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
1262057|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
1262058|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
1262059|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
1262060|NCT00022672|E3|Reported Event|Anastrozole (After Start of Trastuzumab)|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
1262061|NCT00022672|E2|Reported Event|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase.
1262062|NCT00022672|E1|Reported Event|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
1262064|NCT00022659|P1|Participant Flow|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
1262729|NCT00006392|E3|Reported Event|Placebo|Placebo for selenium + placebo for vitamin E
1262065|NCT00022659|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
1262066|NCT00022659|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
1262067|NCT00022659|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
1262068|NCT00022659|E1|Reported Event|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
1262069|NCT00022633|B3|Baseline|Total|Total of all reporting groups
1262070|NCT00022633|B2|Baseline|Paclitaxel + Gemcitabine (Younger Cohort: Age < 60)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
1262071|NCT00022633|B1|Baseline|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
1262072|NCT00022633|P2|Participant Flow|Paclitaxel + Gemcitabine (Younger Cohort: Age < 60)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
1262073|NCT00022633|P1|Participant Flow|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
1262074|NCT00022633|O1|Outcome|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
1262075|NCT00022633|O1|Outcome|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
1262076|NCT00022633|O1|Outcome|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
1262077|NCT00022633|O1|Outcome|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
1262078|NCT00022633|O1|Outcome|Paclitaxel + Gemcitabine|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
1262079|NCT00022633|O1|Outcome|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
1262080|NCT00022633|O1|Outcome|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
1262081|NCT00022633|O1|Outcome|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
1262082|NCT00022633|E1|Reported Event|Paclitaxel + Gemcitabine|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
1262083|NCT00022516|B3|Baseline|Total|Total of all reporting groups
1262084|NCT00022516|B2|Baseline|CM-Maintenance|"12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)~Cyclophosphamide: 50 mg/day orally continuously for 1 year~Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year"
1262085|NCT00022516|B1|Baseline|No-CM|No further chemotherapy following standard adjuvant chemotherapy.
1262086|NCT00022516|P2|Participant Flow|CM-Maintenance|"12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)~Cyclophosphamide: 50 mg/day orally continuously for 1 year~Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year"
1262087|NCT00022516|P1|Participant Flow|No-CM|No further chemotherapy following standard adjuvant chemotherapy.
1262088|NCT00022516|O2|Outcome|CM-Maintenance|"12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)~Cyclophosphamide: 50 mg/day orally continuously for 1 year~Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year"
1262089|NCT00022516|O1|Outcome|No-CM|No further chemotherapy following standard adjuvant chemotherapy.
1262090|NCT00022516|O2|Outcome|CM-Maintenance|"12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)~Cyclophosphamide: 50 mg/day orally continuously for 1 year~Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year"
1262091|NCT00022516|O1|Outcome|No-CM|No further chemotherapy following standard adjuvant chemotherapy.
1262092|NCT00022516|O2|Outcome|CM-Maintenance|"12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)~Cyclophosphamide: 50 mg/day orally continuously for 1 year~Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year"
1262093|NCT00022516|O1|Outcome|No-CM|No further chemotherapy following standard adjuvant chemotherapy.
1262094|NCT00022516|O2|Outcome|CM-Maintenance|"12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)~Cyclophosphamide: 50 mg/day orally continuously for 1 year~Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year"
1262095|NCT00022516|O1|Outcome|No-CM|No further chemotherapy following standard adjuvant chemotherapy.
1262174|NCT00019747|E1|Reported Event|Arm 1 - Thalidomide Once Daily|Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).
1262415|NCT00007475|B4|Baseline|Total|Total of all reporting groups
1262730|NCT00006392|E2|Reported Event|Combination|Selenium + vitamin E
1262096|NCT00022516|E2|Reported Event|CM-Maintenance|"12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)~Cyclophosphamide: 50 mg/day orally continuously for 1 year~Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year"
1262097|NCT00022516|E1|Reported Event|No-CM|No further chemotherapy following standard adjuvant chemotherapy.
1262098|NCT00022490|B1|Baseline|Cytarabine/ Imatinib Mesylate|"Cytarabine: Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle~Imatinib Mesylate: Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months"
1262099|NCT00022490|P1|Participant Flow|Cytarabine/ Imatinib Mesylate|"Cytarabine: Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle~Imatinib Mesylate: Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months"
1262100|NCT00022490|O1|Outcome|Cytarabine/ Imatinib Mesylate|"Cytarabine: Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle~Imatinib Mesylate: Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months"
1262101|NCT00022490|E1|Reported Event|Cytarabine/ Imatinib Mesylate|"Cytarabine: Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle~Imatinib Mesylate: Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months"
1262102|NCT00021541|B3|Baseline|Total|Total of all reporting groups
1262103|NCT00021541|B2|Baseline|Placebo|Patients receive oral placebo every 12 hours on days 1-21. Courses repeat as in arm I. These are the patients that started on placebo only. This number does not reflect the total amount of patients that crossed over to tipifarnib. Two of the 31 patients were deemed ineligible, thus 29 started placebo.
1262104|NCT00021541|B1|Baseline|R115777 (Tipifarnib)|Patients receive oral tipifarnib every 12 hours on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. These are the patients that started on tipifarnib only. This number does not reflect the total amount of patients that crossed over to placebo.
1262105|NCT00021541|P2|Participant Flow|Placebo|Patients receive oral placebo every 12 hours on days 1-21. Courses repeat as in arm I.Patients receive placebo ONLY in the first treatment until they progress to the second treatment/crossover to receive tipifarnib.
1262106|NCT00021541|P1|Participant Flow|Tipifarnib (R11577)|Patients receive oral tipifarnib every 12 hours on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.Patients receive tipifarnib ONLY in the first treatment until they progress to the second treatment/crossover to receive placebo.
1262107|NCT00021541|O1|Outcome|Tipifarnib & Placebo|"Patients receive oral tipifarnib every 12 hours on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Patients receive oral placebo every 12 hours on days 1-21. Courses repeat as in arm I."
1262108|NCT00021541|O2|Outcome|Phase B|Placebo/Tipifarnib
1262109|NCT00021541|O1|Outcome|Phase A|Tipifarnib/placebo
1262110|NCT00021541|E1|Reported Event|Tipifarnib & Placebo|"Patients receive oral tipifarnib every 12 hours on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Patients receive oral placebo every 12 hours on days 1-21. Courses repeat as in arm I."
1262111|NCT00021255|B4|Baseline|Total|Total of all reporting groups
1262112|NCT00021255|B3|Baseline|Docetaxel + Carboplatin + Herceptin (TCH)|Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
1262113|NCT00021255|B2|Baseline|AC Followed by Docetaxel + Herceptin (AC→TH)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
1262114|NCT00021255|B1|Baseline|Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
1262115|NCT00021255|P3|Participant Flow|Docetaxel + Carboplatin + Herceptin (TCH)|Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
1262116|NCT00021255|P2|Participant Flow|AC Followed by Docetaxel + Herceptin (AC→TH)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
1262117|NCT00021255|P1|Participant Flow|Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)|Doxorubicin 60 mg/m² intravenous (IV) bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
1262118|NCT00021255|O3|Outcome|Docetaxel + Carboplatin + Herceptin (TCH)|Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
1262119|NCT00021255|O2|Outcome|AC Followed by Docetaxel + Herceptin (AC→TH)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
1262120|NCT00021255|O1|Outcome|Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
1262121|NCT00021255|O3|Outcome|Docetaxel + Carboplatin + Herceptin (TCH)|Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
1262122|NCT00021255|O2|Outcome|AC Followed by Docetaxel + Herceptin (AC→TH)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
1262123|NCT00021255|O1|Outcome|Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
1262124|NCT00021255|O3|Outcome|Docetaxel + Carboplatin + Herceptin (TCH)|Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
1262125|NCT00021255|O2|Outcome|AC Followed by Docetaxel + Herceptin (AC→TH)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
1262126|NCT00021255|O1|Outcome|Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
1262127|NCT00021255|E3|Reported Event|Docetaxel + Carboplatin + Herceptin (TCH)|Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
1262128|NCT00021255|E2|Reported Event|AC Followed by Docetaxel + Herceptin (AC→TH)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
1262129|NCT00021255|E1|Reported Event|Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
1262130|NCT00021229|B4|Baseline|Total|Total of all reporting groups
1262131|NCT00021229|B3|Baseline|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
1262175|NCT00019604|B1|Baseline|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
1262639|NCT00006489|B1|Baseline|Naltrexone + Supportive Counseling|"Naltrexone alone~Naltrexone: Daily dosing 100 mg for 24 weeks"
1262132|NCT00021229|B2|Baseline|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
1262133|NCT00021229|B1|Baseline|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
1262134|NCT00021229|P3|Participant Flow|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
1262135|NCT00021229|P2|Participant Flow|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
1262136|NCT00021229|P1|Participant Flow|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
1262137|NCT00021229|O3|Outcome|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
1262138|NCT00021229|O2|Outcome|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
1262139|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
1262140|NCT00021229|O3|Outcome|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
1262200|NCT00016913|O1|Outcome|Neo-Adj ChemoTx + Ablation Prior to RT|Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
1262141|NCT00021229|O2|Outcome|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
1262142|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
1262143|NCT00021229|O3|Outcome|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
1262144|NCT00021229|O2|Outcome|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
1262145|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
1262146|NCT00021229|O3|Outcome|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
1262147|NCT00021229|O2|Outcome|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
1262148|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
1262149|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
1262150|NCT00021229|O3|Outcome|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
1262151|NCT00021229|O2|Outcome|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
1262152|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
1262153|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
1262154|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
1262155|NCT00021229|O2|Outcome|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
1262156|NCT00021229|O1|Outcome|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
1262157|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
1262158|NCT00021229|E3|Reported Event|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
1262159|NCT00021229|E2|Reported Event|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
1262160|NCT00021229|E1|Reported Event|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
1262161|NCT00020722|B1|Baseline|Therapeutic Autologous Lymphocytes|"therapeutic autologous lymphocytes: Immediately after pheresis, the lymphocytes will be activated with soluble monoclonal anti-CD3 antibody (OKT3) which cross-links the CD3 receptors on T cells and activates T cells.~The time for ATC infusions will vary from patient to patient, but the infusion rate will be approximately 10 × 109 ATC will be based on the rate calculated from the endotoxin level in the cell product. All patients will be observed for at least 1 hr after an infusion.~Ifosfamide, carboplatin, and etoposide (ICE) regimen: Ifosfamide 2,500 mg/m2 given IV daily on day -8, -7, -6, -5, -4, and -3 prior to PBSCT. Ifosfamide 2,500 mg/m2 infused IV over 1 hour (hour 0-1) on days -8 to -3 for a total dose of 15,000 mg/m2.~Mesna administered per BMT Standard of Care Guideline at a dose of 25% of the total Ifosfamide dose 30 mins. prior to and then 3, 6, and 9 hrs after ifosfamide daily on days -8, -7, -6, -5, -4, and -3 prior to PBSCT for a total dose of 2500 m"
1262162|NCT00020722|P1|Participant Flow|Therapeutic Autologous Lymphocytes|"therapeutic autologous lymphocytes: Immediately after pheresis.,The time for ATC infusions will vary from patient to patient, but the infusion rate will be approximately 10 × 109 ATC will be based on the rate calculated from the endotoxin level in the cell product. All patients will be observed for at least 1 hr after an infusion.~Ifosfamide, carboplatin, and etoposide (ICE) regimen: Ifosfamide 2,500 mg/m2 given IV daily on day -8, -7, -6, -5, -4, and -3 prior to PBSCT. Ifosfamide 2,500 mg/m2 infused IV over 1 hour (hour 0-1) on days -8 to -3 for a total dose of 15,000 mg/m2.~Mesna will be administered per BMT Standard of Care Guideline at a dose of 25% of the total Ifosfamide dose 30 minutes prior to and then 3, 6, and 9 hours after ifosfamide daily on days -8, -7, -6, -5, -4, and -3 prior to PBSCT for a total dose of 2500 m"
1262163|NCT00020722|O1|Outcome|Therapeutic Autologous Lymphocytes|"therapeutic autologous lymphocytes: Immediately after pheresis, the lymphocytes will be activated with soluble monoclonal anti-CD3 antibody (OKT3) which cross-links the CD3 receptors on T cells and activates T cells.~The time for ATC infusions will vary from patient to patient, but the infusion rate will be based on the rate calculated from the endotoxin level in the cell product. All patients will be observed for at least 1 hr after an infusion.~Ifosfamide, carboplatin, and etoposide (ICE) regimen: Ifosfamide 2,500 mg/m2 given IV daily on day -8, -7, -6, -5, -4, and -3 prior to PBSCT. Ifosfamide 2,500 mg/m2 infused IV over 1 hour (hour 0-1) on days -8 to -3 for a total dose of 15,000 mg/m2.~Mesna will be administered per BMT Standard of Care Guideline at a dose of 25% of the total Ifosfamide dose 30 minutes prior to and then 3, 6, and 9 hours after ifosfamide daily on days -8, -7, -6, -5, -4, and -3 prior to PBSCT for a total dose of 2500 mg/m2.~Carboplatin at a dose of"
1262164|NCT00020722|O1|Outcome|Therapeutic Autologous Lymphocytes|"therapeutic autologous lymphocytes: Immediately after pheresis.~The time for ATC infusions will vary from patient to patient, but the infusion rate will be approximately 10 × 109 ATC will be based on the rate calculated from the endotoxin level in the cell product. All patients will be observed for at least 1 hr after an infusion.~Ifosfamide, carboplatin, and etoposide (ICE) regimen: Ifosfamide 2,500 mg/m2 given IV daily on day -8, -7, -6, -5, -4, and -3 prior to PBSCT. Ifosfamide 2,500 mg/m2 infused IV over 1 hour (hour 0-1) on days -8 to -3 for a total dose of 15,000 mg/m2.~Mesna will be administered per BMT Standard of Care Guideline at a dose of 25% of the total Ifosfamide dose 30 minutes prior to and then 3, 6, and 9 hours after ifosfamide daily on days -8, -7, -6, -5, -4, and -3 prior to PBSCT for a total dose of 2500 m"
1262165|NCT00020722|E1|Reported Event|Therapeutic Autologous Lymphocytes|"therapeutic autologous lymphocytes: Immediately after pheresis.,The time for ATC infusions will vary from patient to patient, but the infusion rate will be approximately 10 × 109 ATC will be based on the rate calculated from the endotoxin level in the cell product. All patients will be observed for at least 1 hr after an infusion.~Ifosfamide, carboplatin, and etoposide (ICE) regimen: Ifosfamide 2,500 mg/m2 given IV daily on day -8, -7, -6, -5, -4, and -3 prior to PBSCT. Ifosfamide 2,500 mg/m2 infused IV over 1 hour (hour 0-1) on days -8 to -3 for a total dose of 15,000 mg/m2.~Mesna will be administered per BMT Standard of Care Guideline at a dose of 25% of the total Ifosfamide dose 30 minutes prior to and then 3, 6, and 9 hours after ifosfamide daily on days -8, -7, -6, -5, -4, and -3 prior to PBSCT for a total dose of 2500 m"
1262166|NCT00019747|B3|Baseline|Total|Total of all reporting groups
1262167|NCT00019747|B2|Baseline|Arm 2 - Placebo Once Daily|Patients receive oral placebo once daily.
1262168|NCT00019747|B1|Baseline|Arm 1 - Thalidomide Once Daily|Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).
1262169|NCT00019747|P2|Participant Flow|Arm 2 - Placebo Once Daily|Patients receive oral placebo once daily.
1262170|NCT00019747|P1|Participant Flow|Arm 1 - Thalidomide Once Daily|Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).
1262171|NCT00019747|O2|Outcome|Arm 2 - Placebo Once Daily|Patients receive oral placebo once daily.
1262172|NCT00019747|O1|Outcome|Arm 1 - Thalidomide Once Daily|Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).
1262176|NCT00019604|P1|Participant Flow|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
1262177|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
1262178|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
1262179|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
1262180|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
1262181|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
1262182|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
1262183|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
1262184|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
1262185|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
1262186|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
1262187|NCT00019604|E1|Reported Event|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
1262188|NCT00018031|B1|Baseline|Peg-interefron Alfa 2b, Ribavirin|"Weekly Injection~Peginterferon alpha-2b : Weekly injections for 48 weeks of a dose of 1.5mcg/Kg per week subcutaneously~Oral Pills~Ribavirin : Weight based Ribavirin dosing 1-1.2grams/day in divided (twice daily) doses for a total duration of 48 weeks."
1262189|NCT00018031|P1|Participant Flow|Peginterferon Alfa-2b, Ribavirin|"Weekly Injection (Peginterferon alfa-2b)~Peginterferon Alfa-2b : Weekly injections for 48 weeks of a dose of 1.5mcg/Kg per week subcutaneously~Oral Pills (Ribavirin)~Ribavirin : Weight based Ribavirin dosing 1-1.2grams/day in divided (twice daily) doses for a total duration of 48 weeks."
1262190|NCT00018031|O1|Outcome|Peginterferon Alfa-2b, Ribavirin|"Weekly Injection (Peginterferon alfa-2b)~Peginterferon Alfa-2b : Weekly injections for 48 weeks of a dose of 1.5mcg/Kg per week subcutaneously~Oral Pills (Ribavirin)~Ribavirin : Weight based Ribavirin dosing 1-1.2grams/day in divided (twice daily) doses for a total duration of 48 weeks."
1262191|NCT00018031|E1|Reported Event|Peg-interefron Alfa 2b, Ribavirin|"Weekly Injection~Peginterferon alpha-2b : Weekly injections for 48 weeks of a dose of 1.5mcg/Kg per week subcutaneously~Oral Pills~Ribavirin : Weight based Ribavirin dosing 1-1.2grams/day in divided (twice daily) doses for a total duration of 48 weeks."
1262192|NCT00017563|B1|Baseline|Docetaxel and Mitox|"Drug: docetaxel~35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.~Drug: mitoxantrone hydrochloride~Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks."
1262193|NCT00017563|P1|Participant Flow|Docetaxel and Mitox|"Drug: docetaxel~35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.~Drug: mitoxantrone hydrochloride~Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks."
1262194|NCT00017563|O1|Outcome|Docetaxel and Mitox|"Drug: docetaxel~35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.~Drug: mitoxantrone hydrochloride~Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks."
1262195|NCT00017563|E1|Reported Event|Docetaxel and Mitox|"Drug: docetaxel~35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.~Drug: mitoxantrone hydrochloride~Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks."
1262196|NCT00016913|B1|Baseline|Neo-Adj ChemoTx + Ablation Prior to RT|Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
1262197|NCT00016913|P1|Participant Flow|Neo-Adj ChemoTx + Ablation Prior to RT|Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
1262198|NCT00016913|O1|Outcome|Neo-Adj ChemoTx + Ablation Prior to RT|Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
1262199|NCT00016913|O1|Outcome|Neo-Adj ChemoTx + Ablation Prior to RT|Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
1262201|NCT00016913|E1|Reported Event|Neo-Adj ChemoTx + Ablation Prior to RT|Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer.
1262202|NCT00016354|B1|Baseline|Benzoylphenylurea|BPU, administered over a dose range of 5–320 mg
1262203|NCT00016354|P8|Participant Flow|Benzoylphenylurea Dose Level of 150 mg|Benzoylphenylurea dose level of 150 mg; Dose level 8 (for this dose level, a 25 mg capsule was used. At all previous dose levels, a 5 mg capsule was administered.)
1262204|NCT00016354|P7|Participant Flow|Benzoylphenylurea 320 mg|Benzoylphenylurea dose level of 320 mg; Dose level 7
1262205|NCT00016354|P6|Participant Flow|Benzoylphenylurea 160 mg|Benzoylphenylurea dose level of 160 mg; Dose level 6
1262206|NCT00016354|P5|Participant Flow|Benzoylphenylurea 80 mg|Benzoylphenylurea dose level of 80 mg; Dose level 5
1262207|NCT00016354|P4|Participant Flow|Benzoylphenylurea 40 mg|Benzoylphenylurea dose level of 40 mg; Dose level 4
1262208|NCT00016354|P3|Participant Flow|Benzoylphenylurea 20 mg|Benzoylphenylurea dose level of 20 mg; Dose level 3
1262209|NCT00016354|P2|Participant Flow|Benzoylphenylurea 10 mg|Benzoylphenylurea dose level of 10 mg; Dose level 2
1262210|NCT00016354|P1|Participant Flow|Benzoylphenylurea 5 mg|Benzoylphenylurea dose level of 5 mg; Dose level 1
1262211|NCT00016354|O1|Outcome|Benzoylphenylurea|BPU, administered over a dose range of 5-320 mg
1262212|NCT00016354|E1|Reported Event|Benzoylphenylurea|BPU, administered over a dose range of 5-320 mg
1262213|NCT00015847|B1|Baseline|Imatinib Mesylate|Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
1262214|NCT00015847|P1|Participant Flow|Imatinib Mesylate|Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
1262215|NCT00015847|O1|Outcome|Imatinib Mesylate|Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
1262216|NCT00015847|O1|Outcome|Imatinib Mesylate|Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
1262217|NCT00015847|O1|Outcome|Imatinib Mesylate|Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
1262218|NCT00015847|E1|Reported Event|Imatinib Mesylate|Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
1262219|NCT00015457|B1|Baseline|Cervical Dystonia|All participants enrolled in study
1262220|NCT00015457|P2|Participant Flow|Placebo Then Amlodipine|Patients with cervical dystonia receiving botulinum toxin injections plus Placebo during the first period and botulinum toxin injections plus Amlodipine during the second period.
1262221|NCT00015457|P1|Participant Flow|Amlodipine Then Placebo|Patients with cervical dystonia receiving botulinum toxin injections plus Amlodipine during the first period and botulinum toxin injections plus Placebo during the second period.
1262222|NCT00015457|O2|Outcome|Placebo|Patients receiving Placebo plus botulinum toxin injections during either period.
1262223|NCT00015457|O1|Outcome|Amlodipine|Patients receiving Amlodipine plus botulinum toxin injections during either period.
1262224|NCT00015457|O2|Outcome|Placebo|Patients receiving Placebo plus botulinum toxin injections during either period.
1262225|NCT00015457|O1|Outcome|Amlodipine|Patients receiving Amlodipine plus botulinum toxin injections during either period.
1262226|NCT00015457|E2|Reported Event|Placebo|Patients receiving Placebo plus botulinum toxin injections during either period.
1262227|NCT00015457|E1|Reported Event|Amlodipine|Patients receiving Amlodipine plus botulinum toxin injections during either period.
1262228|NCT00014911|B1|Baseline|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:~Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.~Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.~Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
1262229|NCT00014911|P1|Participant Flow|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:~Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.~Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.~Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
1262230|NCT00014911|O1|Outcome|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:~Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.~Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.~Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
1262329|NCT00011986|O5|Outcome|Carbo/Gemcitabine - Carbo/Taxol|Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
1262640|NCT00006489|P4|Participant Flow|Placebo + Supportive Counseling|"Placebo alone~Placebo: Pill Placebo daily dosing 24 weeks"
1262231|NCT00014911|O1|Outcome|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:~Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.~Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.~Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
1262232|NCT00014911|O1|Outcome|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:~Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.~Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.~Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
1262233|NCT00014911|O1|Outcome|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:~Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.~Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.~Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
1262234|NCT00014911|O1|Outcome|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:~Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.~Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.~Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
1262235|NCT00014911|O1|Outcome|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:~Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.~Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.~Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
1262236|NCT00014911|E1|Reported Event|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:~Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.~Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.~Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
1262237|NCT00014560|B1|Baseline|Single Arm|This is a Phase 1a/1b trial. three patients will be treated at dose level 1.If no Grade 3 or 4 toxicities, the next dose level will be given to a new cohort of three. If 1 of 3 patients suffer Grade 3 or 4 toxicity, an additional 3 patients will be treated at same dose level.if 1/6 have a Grade 3 or 4 toxicity, proceed to next dose level with a cohort of 3 patients. If > 1/6 experience garde 3 or 4 toxicity, the DLT has been reached and the MTD is the dose level prior. Six patients will be treated at the MTD.
1262238|NCT00014560|P1|Participant Flow|Single Arm|This is a Phase 1a/1b trial. three patients will be treated at dose level 1.If no Grade 3 or 4 toxicities, the next dose level will be given to a new cohort of three. If 1 of 3 patients suffer Grade 3 or 4 toxicity, an additional 3 patients will be treated at same dose level.if 1/6 have a Grade 3 or 4 toxicity, proceed to next dose level with a cohort of 3 patients. If > 1/6 experience garde 3 or 4 toxicity, the DLT has been reached and the MTD is the dose level prior. Six patients will be treated at the MTD.
1262239|NCT00014560|O1|Outcome|Single Arm|This is a Phase 1a/1b trial. three patients will be treated at dose level 1.If no Grade 3 or 4 toxicities, the next dose level will be given to a new cohort of three. If 1 of 3 patients suffer Grade 3 or 4 toxicity, an additional 3 patients will be treated at same dose level.if 1/6 have a Grade 3 or 4 toxicity, proceed to next dose level with a cohort of 3 patients. If > 1/6 experience garde 3 or 4 toxicity, the DLT has been reached and the MTD is the dose level prior. Six patients will be treated at the MTD.
1262240|NCT00014560|E1|Reported Event|Single Arm|This is a Phase 1a/1b trial. three patients will be treated at dose level 1.If no Grade 3 or 4 toxicities, the next dose level will be given to a new cohort of three. If 1 of 3 patients suffer Grade 3 or 4 toxicity, an additional 3 patients will be treated at same dose level.if 1/6 have a Grade 3 or 4 toxicity, proceed to next dose level with a cohort of 3 patients. If > 1/6 experience garde 3 or 4 toxicity, the DLT has been reached and the MTD is the dose level prior. Six patients will be treated at the MTD.
1262241|NCT00014495|B5|Baseline|Total|Total of all reporting groups
1262242|NCT00014495|B4|Baseline|Bismuth-labeled HuM195 (1.25 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
1262243|NCT00014495|B3|Baseline|Bismuth-labeled HuM195 (1 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
1262244|NCT00014495|B2|Baseline|Bismuth-labeled HuM195 (0.75 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
1262245|NCT00014495|B1|Baseline|Bismuth-labeled HuM195 (0.5 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
1262246|NCT00014495|P4|Participant Flow|Bismuth-labeled HuM195 (1.25 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
1262247|NCT00014495|P3|Participant Flow|Bismuth-labeled HuM195 (1 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
1262248|NCT00014495|P2|Participant Flow|Bismuth-labeled HuM195 (0.75 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
1262249|NCT00014495|P1|Participant Flow|Bismuth-labeled HuM195 (0.5 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
1262276|NCT00012298|B6|Baseline|Treatment: Trial 3, Dose Level 6|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
1262718|NCT00006392|O2|Outcome|Selenium|Selenium + matching placebo for vitamin E
1262250|NCT00014495|O1|Outcome|Bismuth Bi 213 Monoclonal Antibody M195 & Cytarabine|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD.~Patients are followed twice weekly for 4 weeks and then monthly for 3 months~filgrastim~cytarabine~bismuth Bi213 monoclonal antibody M195"
1262251|NCT00014495|E4|Reported Event|Bismuth-labeled HuM195 (1.25 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
1262252|NCT00014495|E3|Reported Event|Bismuth-labeled HuM195 (1 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
1262253|NCT00014495|E2|Reported Event|Bismuth-labeled HuM195 (0.75 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
1262254|NCT00014495|E1|Reported Event|Bismuth-labeled HuM195 (0.5 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
1262255|NCT00013611|B3|Baseline|Total|Total of all reporting groups
1262256|NCT00013611|B2|Baseline|Antiretroviral Therapy Only|
1262257|NCT00013611|B1|Baseline|Proleukin Plus Antiretroviral Therapy|
1262258|NCT00013611|P2|Participant Flow|Antiretroviral Therapy Only|All patients must be prescribed combination antiretroviral drug treatment. The choice of combination therapy is left to the discretion of the treating clinician. Investigators will use their national guidelines for determining when antiretroviral therapy should be changed and for when determining when therapy should be used.
1262259|NCT00013611|P1|Participant Flow|Proleukin Plus Antiretroviral Therapy|Patients receive an initial dose of 4.5 MIU of proleukin twice daily for 5 consecutive days every 8 weeks during the first year (6 cycles total). After the first year, additional cycles are given to either achieve or maintain the patient's CD4+ count goal. CD4+ goal is defined as an increase of 125 cells/cubic mm for participants in the 50-199 CD4+ count stratum, and an increase of 175 cells/cubic mm for participants in the 200-299 CD4+ stratum. In addition, all patients must be prescribed combination antiretroviral drug treatment. The choice of combination therapy is left to the discretion of the treating clinician. Investigators will use their national guidelines for determining when antiretroviral therapy should be changed and for when determining when therapy should be used. All patients must take antiretroviral therapy during each 5-consecutive-day treatment cycle.
1262260|NCT00013611|O2|Outcome|Antiretroviral Therapy Only|
1262261|NCT00013611|O1|Outcome|Proleukin Plus Antiretroviral Therapy|
1262262|NCT00013611|O2|Outcome|Antiretroviral Therapy Only|
1262263|NCT00013611|O1|Outcome|Proleukin Plus Antiretroviral Therapy|
1262264|NCT00013611|O2|Outcome|Antiretroviral Therapy Only|
1262265|NCT00013611|O1|Outcome|Proleukin Plus Antiretroviral Therapy|
1262266|NCT00013611|O2|Outcome|Antiretroviral Therapy Only|
1262267|NCT00013611|O1|Outcome|Proleukin Plus Antiretroviral Therapy|
1262268|NCT00013611|O2|Outcome|Antiretroviral Therapy Only|
1262269|NCT00013611|O1|Outcome|Proleukin Plus Antiretroviral Therapy|
1262270|NCT00013611|O2|Outcome|Antiretroviral Therapy Only|
1262271|NCT00013611|O1|Outcome|Proleukin Plus Antiretroviral Therapy|
1262272|NCT00013611|E2|Reported Event|Antiretroviral Therapy Only|
1262273|NCT00013611|E1|Reported Event|Proleukin Plus Antiretroviral Therapy|
1262274|NCT00012298|B8|Baseline|Total|Total of all reporting groups
1262275|NCT00012298|B7|Baseline|Treatment : Phase II (Dose Level 6)|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
1262277|NCT00012298|B5|Baseline|Treatment: Trial 3, Dose Level 5|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
1262278|NCT00012298|B4|Baseline|Treatment: Trial 2, Dose Level 4|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
1262279|NCT00012298|B3|Baseline|Treatment: Trial 2, Dose Level 3|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
1262280|NCT00012298|B2|Baseline|Treatment: Trial 1, Dose Level 2|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8"
1262281|NCT00012298|B1|Baseline|Treatment: Trial 1, Dose Level 1|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8."
1262282|NCT00012298|P7|Participant Flow|Treatment : Phase II (Dose Level 6)|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
1262283|NCT00012298|P6|Participant Flow|Treatment: Trial 3, Dose Level 6|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
1262284|NCT00012298|P5|Participant Flow|Treatment: Trial 3, Dose Level 5|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
1262285|NCT00012298|P4|Participant Flow|Treatment: Trial 2, Dose Level 4|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
1262286|NCT00012298|P3|Participant Flow|Treatment: Trial 2, Dose Level 3|"Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
1262325|NCT00011986|P4|Participant Flow|Carbo/Topotecan - Carbo/Taxol|Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
1262326|NCT00011986|P3|Participant Flow|Carbo/Taxol/Doxil|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles
1262287|NCT00012298|P2|Participant Flow|Treatment: Trial 1, Dose Level 2|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8."
1262288|NCT00012298|P1|Participant Flow|Treatment: Trial 1, Dose Level 1|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8."
1262289|NCT00012298|O1|Outcome|Treatment : Dose Level 6|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
1262290|NCT00012298|O6|Outcome|Treatment: Trial 3, Dose Level 6|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
1262291|NCT00012298|O5|Outcome|Treatment: Trial 3, Dose Level 5|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
1262292|NCT00012298|O4|Outcome|Treatment: Trial 2, Dose Level 4|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
1262293|NCT00012298|O3|Outcome|Treatment: Trial 2, Dose Level 3|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
1262294|NCT00012298|O2|Outcome|Treatment: Trial 1, Dose Level 2|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8"
1262295|NCT00012298|O1|Outcome|Treatment: Trial 1, Dose Level 1|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8"
1262296|NCT00012298|O6|Outcome|Treatment: Trial 3, Dose Level 6|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
1262297|NCT00012298|O5|Outcome|Treatment: Trial 3, Dose Level 5|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
1262411|NCT00007644|O2|Outcome|Watchful Waiting|Closely watching, waiting and treating symptoms if and when cancer progresses
1262298|NCT00012298|O4|Outcome|Treatment: Trial 2, Dose Level 4|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
1262299|NCT00012298|O3|Outcome|Treatment: Trial 2, Dose Level 3|"Patients receive:~Cycle 1:~50 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
1262300|NCT00012298|O2|Outcome|Treatment: Trial 1, Dose Level 2|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8"
1262301|NCT00012298|O1|Outcome|Treatment: Trial 1, Dose Level 1|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8"
1262302|NCT00012298|E7|Reported Event|Treatment : Phase II (Dose Level 6)|50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
1262303|NCT00012298|E6|Reported Event|Treatment: Trial 3, Dose Level 6|50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
1262304|NCT00012298|E5|Reported Event|Treatment: Trial 3, Dose Level 5|50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
1262305|NCT00012298|E4|Reported Event|Treatment: Trial 2, Dose Level 4|50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.
1262306|NCT00012298|E3|Reported Event|Treatment: Trial 2, Dose Level 3|50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.
1262307|NCT00012298|E2|Reported Event|Treatment: Trial 1, Dose Level 2|0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
1262308|NCT00012298|E1|Reported Event|Treatment: Trial 1, Dose Level 1|0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
1262309|NCT00012012|B3|Baseline|Total|Total of all reporting groups
1262310|NCT00012012|B2|Baseline|Radiation Therapy Plus Cisplatin & Amifostine|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate.
1262311|NCT00012012|B1|Baseline|Radiation Therapy Plus Cisplatin|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin.
1262312|NCT00012012|P2|Participant Flow|Radiation Therapy Plus Cisplatin & Amifostine|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate.
1262313|NCT00012012|P1|Participant Flow|Radiation Therapy Plus Cisplatin|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin.
1262314|NCT00012012|O1|Outcome|Radiation Therapy Plus Cisplatin and Amifostine|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate.
1262315|NCT00012012|O1|Outcome|Radiation Therapy Plus Cisplatin|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin.
1262316|NCT00012012|E2|Reported Event|Radiation Therapy Plus Cisplatin & Amifostine|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate.
1262317|NCT00012012|E1|Reported Event|Radiation Therapy Plus Cisplatin|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin.
1262318|NCT00011986|B6|Baseline|Total|Total of all reporting groups
1262319|NCT00011986|B5|Baseline|Carbo/Gemcitabine - Carbo/Taxol|Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
1262320|NCT00011986|B4|Baseline|Carbo/Topotecan - Carbo/Taxol|Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
1262321|NCT00011986|B3|Baseline|Carbo/Taxol/Doxil|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles
1262322|NCT00011986|B2|Baseline|Carbo/Taxol/Gemcitabine|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles
1262323|NCT00011986|B1|Baseline|Carbo/Taxol|Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles
1262324|NCT00011986|P5|Participant Flow|Carbo/Gemcitabine - Carbo/Taxol|Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
1262327|NCT00011986|P2|Participant Flow|Carbo/Taxol/Gemcitabine|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles
1262330|NCT00011986|O4|Outcome|Carbo/Topotecan - Carbo/Taxol|Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
1262331|NCT00011986|O3|Outcome|Carbo/Taxol/Doxil|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles
1262332|NCT00011986|O2|Outcome|Carbo/Taxol/Gemcitabine|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles
1262333|NCT00011986|O1|Outcome|Carbo/Taxol|Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles
1262334|NCT00011986|E5|Reported Event|Carbo/Gemcitabine - Carbo/Taxol|Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
1262335|NCT00011986|E4|Reported Event|Carbo/Topotecan - Carbo/Taxol|Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
1262336|NCT00011986|E3|Reported Event|Carbo/Taxol/Doxil|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles
1262337|NCT00011986|E2|Reported Event|Carbo/Taxol/Gemcitabine|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles
1262338|NCT00011986|E1|Reported Event|Carbo/Taxol|Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles
1262339|NCT00010803|B3|Baseline|Total|Total of all reporting groups
1262340|NCT00010803|B2|Baseline|Placebo|Placebo 1 pill twice daily
1262341|NCT00010803|B1|Baseline|Ginkgo Biloba|120 mg twice daily, total 240 mg
1262342|NCT00010803|P2|Participant Flow|Placebo|Placebo twice daily
1262343|NCT00010803|P1|Participant Flow|Ginkgo Biloba|EGb 761 Ginkgo biloba 120 mg twice daily
1262344|NCT00010803|O2|Outcome|Placebo|Placebo 1 pill twice a day
1262345|NCT00010803|O1|Outcome|Ginkgo Biloba|120 mg twice daily, total 240 mg
1262346|NCT00010803|O2|Outcome|Placebo|Placebo 1 pill twice a day
1262347|NCT00010803|O1|Outcome|Ginkgo Biloba|120 mg twice daily, total 240 mg
1262348|NCT00010803|O2|Outcome|Placebo|Placebo 1 pill twice a day
1262349|NCT00010803|O1|Outcome|Ginkgo Biloba|120 mg twice daily, total 240 mg
1262350|NCT00010803|E2|Reported Event|Placebo|Placebo twice daily
1262351|NCT00010803|E1|Reported Event|Ginkgo Biloba|EGb 761 Ginkgo biloba 120 mg twice daily
1262352|NCT00010439|B1|Baseline|Alendronate|Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.
1262353|NCT00010439|P1|Participant Flow|Alendronate|Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.
1262354|NCT00010439|O1|Outcome|Alendronate|Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.
1262355|NCT00010439|O1|Outcome|Alendronate|Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.
1262356|NCT00010439|E1|Reported Event|Alendronate|Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.
1262357|NCT00010257|B3|Baseline|Total|Total of all reporting groups
1262358|NCT00010257|B2|Baseline|Thymic Carcinoma|Patients with diagnosis of thymic carcinoma
1262359|NCT00010257|B1|Baseline|Thymoma|Patients with diagnosis of thymoma
1262360|NCT00010257|P2|Participant Flow|Thymic Carcinoma|Patients with diagnosis of thymic carcinoma
1262361|NCT00010257|P1|Participant Flow|Thymoma|Patients with diagnosis of thymoma
1262362|NCT00010257|O2|Outcome|Thymic Carcinoma|Patients with diagnosis of thymic carcinoma
1262363|NCT00010257|O1|Outcome|Thymoma|Patients with diagnosis of thymoma
1262364|NCT00010257|O2|Outcome|Thymic Carcinoma|Patients with diagnosis of thymic carcinoma
1262365|NCT00010257|O1|Outcome|Thymoma|Patients with diagnosis of thymoma
1262366|NCT00010257|E2|Reported Event|Thymic Carcinoma|Patients with diagnosis of thymic carcinoma
1262367|NCT00010257|E1|Reported Event|Thymoma|Patients with diagnosis of thymoma
1262368|NCT00009737|B3|Baseline|Total|Total of all reporting groups
1262369|NCT00009737|B2|Baseline|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
1262370|NCT00009737|B1|Baseline|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
1262371|NCT00009737|P2|Participant Flow|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
1262372|NCT00009737|P1|Participant Flow|Capecitabine|Participants received capecitabine 1250 milligram per square meter (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
1262373|NCT00009737|O2|Outcome|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
1262374|NCT00009737|O1|Outcome|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
1262375|NCT00009737|O2|Outcome|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
1262412|NCT00007644|O1|Outcome|Radical Prostatectomy|Surgical removal of the prostate
1262719|NCT00006392|O1|Outcome|Vitamin E|Vitamin E + matching placebo for selenium
1262376|NCT00009737|O1|Outcome|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
1262377|NCT00009737|O2|Outcome|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
1262378|NCT00009737|O1|Outcome|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
1262379|NCT00009737|O2|Outcome|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
1262380|NCT00009737|O1|Outcome|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
1262381|NCT00009737|O2|Outcome|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
1262382|NCT00009737|O1|Outcome|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
1262383|NCT00009737|O2|Outcome|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
1262384|NCT00009737|O1|Outcome|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
1262385|NCT00009737|E2|Reported Event|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
1262386|NCT00009737|E1|Reported Event|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
1262387|NCT00008385|B3|Baseline|Total|Total of all reporting groups
1262388|NCT00008385|B2|Baseline|Arm II (Selenium)|"Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.~selenium: Given orally"
1262389|NCT00008385|B1|Baseline|Arm I (Placebo)|"Participants receive an oral yeast placebo as in arm II.~placebo: Given orally"
1262390|NCT00008385|P2|Participant Flow|Arm II (Selenium)|"Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.~selenium: Given orally"
1262391|NCT00008385|P1|Participant Flow|Arm I (Placebo)|"Participants receive an oral yeast placebo as in arm II.~placebo: Given orally"
1262392|NCT00008385|O2|Outcome|Arm II (Selenium)|"Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.~selenium: Given orally"
1262393|NCT00008385|O1|Outcome|Arm I (Placebo)|"Participants receive an oral yeast placebo as in arm II.~placebo: Given orally"
1262394|NCT00008385|O2|Outcome|Arm II (Selenium)|"Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.~selenium: Given orally"
1262395|NCT00008385|O1|Outcome|Arm I (Placebo)|"Participants receive an oral yeast placebo as in arm II.~placebo: Given orally"
1262396|NCT00008385|O2|Outcome|Arm II (Selenium)|"Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.~selenium: Given orally"
1262397|NCT00008385|O1|Outcome|Arm I (Placebo)|"Participants receive an oral yeast placebo as in arm II.~placebo: Given orally"
1262398|NCT00008385|E2|Reported Event|Arm II (Selenium)|"Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.~selenium: Given orally"
1262399|NCT00008385|E1|Reported Event|Arm I (Placebo)|Participants receive an oral yeast placebo as in arm II. placebo: Given orally
1262400|NCT00008138|B1|Baseline|Experimental: Chemo/Debulking Surgery/IP Chemo|neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel)
1262401|NCT00008138|P1|Participant Flow|Experimental: Chemo/Debulking Surgery/IP Chemo|neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel)
1262402|NCT00008138|O1|Outcome|Experimental: Chemo/Debulking Surgery/IP Chemo|neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel)
1262403|NCT00008138|O1|Outcome|Experimental: Chemo/Debulking Surgery/IP Chemo|neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel)
1262404|NCT00008138|E2|Reported Event|Post-Cytoreduction Paclitaxel (IV/IP) + Carboplatin (IP)|post-surgery chemotherapy with IV and IP carboplatin and paclitaxel
1262405|NCT00008138|E1|Reported Event|Neoadjuvant Paclitaxel (IV) + Carboplatin (V)|Pre-surgery IV chemotherapy with paclitaxel and carboplatin
1262406|NCT00007644|B3|Baseline|Total|Total of all reporting groups
1262407|NCT00007644|B2|Baseline|Watchful Waiting|Closely watching, waiting and treating symptoms if and when cancer progresses
1262408|NCT00007644|B1|Baseline|Radical Prostatectomy|Surgical removal of the prostate
1262409|NCT00007644|P2|Participant Flow|Watchful Waiting|Closely watching, waiting and treating symptoms if and when cancer progresses
1262410|NCT00007644|P1|Participant Flow|Radical Prostatectomy|Surgical removal of the prostate
1262720|NCT00006392|O4|Outcome|Placebo|Matching placebo for vitamin E + matching placebo for selenium
1262416|NCT00007475|B3|Baseline|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Protocol Group D (FPF 0.6 or greater pre-initial Transplant); group size is limited due to limited availability of validated FPF assay
1262417|NCT00007475|B2|Baseline|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
1262418|NCT00007475|B1|Baseline|FPF NOT Assayed Provisionally, PE + Cyclophosphamide Completed|Participants not provisionally assayed for FPF, yet still complete both series of protocol treatment: Plasma Exchange (PE) and Cyclophosphamide; note that these form a majority of enrollees due to limited availability of validated FPF assay (such an assay has not yet been developed to an extent that it could be applied to all enrollees of this current trial; see Outcome Measures for more details)
1262419|NCT00007475|P4|Participant Flow|Historical Controls|Noted as Group F in study protocol: historical control patients, including patients at NIH or other institutions who have previously undergone renal transplant, for whom stored sera are available, and for whom consent to measure FPF has been can be obtained. In some cases, these measurements have been performed by Dr. Savin under pre-existing protocols and these data are already available.
1262420|NCT00007475|P3|Participant Flow|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Protocol Group D (FPF 0.6 or greater pre-initial Transplant); group size is limited due to limited availability of provisionally validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
1262421|NCT00007475|P2|Participant Flow|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of provisionally validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
1262422|NCT00007475|P1|Participant Flow|FPF NOT Assayed, Plasma Exchange + Cyclophosphamide Completed|Participants not assayed for FSGS Permeability Factor (FPF) levels pre-treatment (Tx), yet still complete both series of protocol-specified treatment; FPF levels NOT available as its assay has not yet been developed to an extent that it could be applied to all enrollees of this current trial
1262423|NCT00007475|O3|Outcome|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Protocol Group D (FPF 0.6 or greater pre-initial Transplant)
1262424|NCT00007475|O2|Outcome|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
1262425|NCT00007475|O1|Outcome|Plasma Exchange + Cyclophosphamide, Complete Treatment|Participants complete both series of protocol treatment
1262426|NCT00007475|O3|Outcome|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Protocol Group D (FPF 0.6 or greater pre-initial Transplant)
1262427|NCT00007475|O2|Outcome|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
1262428|NCT00007475|O1|Outcome|Plasma Exchange + Cyclophosphamide, Complete Treatment|Participants complete both series of protocol treatment
1262429|NCT00007475|O3|Outcome|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Protocol Group D (FPF 0.6 or greater pre-initial Transplant)
1262430|NCT00007475|O2|Outcome|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
1262431|NCT00007475|O1|Outcome|Plasma Exchange + Cyclophosphamide, Complete Treatment|Participants complete both series of protocol treatment
1262432|NCT00007475|O3|Outcome|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Protocol Group D (FPF 0.6 or greater pre-initial Transplant)
1262433|NCT00007475|O2|Outcome|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
1262434|NCT00007475|O1|Outcome|FPF NOT Assayed, Plasma Exchange + Cyclophosphamide Completed|Participants complete both series of protocol treatment: Plasma Exchange + Cyclophosphamide
1262435|NCT00007475|O3|Outcome|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Protocol Group D (FPF 0.6 or greater pre-initial Transplant)
1262436|NCT00007475|O2|Outcome|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
1262437|NCT00007475|O1|Outcome|FPF NOT Assayed, Plasma Exchange + Cyclophosphamide Completed|Participants complete both series of protocol treatment, Plasma Exchange and Cyclophosphamide.
1262438|NCT00007475|E3|Reported Event|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Original protocol Group D (FPF 0.6 or greater pre-initial Transplant)
1262439|NCT00007475|E2|Reported Event|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Original protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
1262440|NCT00007475|E1|Reported Event|Plasma Exchange + Cyclophosphamide, Complete Treatment|Participants for whom the Focal Segmental Glomerulosclerosis (FSGS) Permeability Factor, or FPF was not able to be assayed, yet enrolled and completed both protocol-specified interventions: the plasma exchange procedure and treatment by cyclophosphamide.
1262441|NCT00007345|B3|Baseline|Total|Total of all reporting groups
1262442|NCT00007345|B2|Baseline|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
1262443|NCT00007345|B1|Baseline|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
1262444|NCT00007345|P2|Participant Flow|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
1262445|NCT00007345|P1|Participant Flow|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
1262446|NCT00007345|O2|Outcome|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
1262447|NCT00007345|O1|Outcome|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
1262448|NCT00007345|O2|Outcome|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
1262449|NCT00007345|O1|Outcome|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
1262450|NCT00007345|O2|Outcome|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
1262451|NCT00007345|O1|Outcome|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
1262452|NCT00007345|O2|Outcome|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
1262453|NCT00007345|O1|Outcome|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
1262454|NCT00007345|O2|Outcome|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
1262455|NCT00007345|O1|Outcome|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
1262456|NCT00007345|O2|Outcome|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
1262457|NCT00007345|O1|Outcome|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
1262458|NCT00007345|O2|Outcome|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
1262459|NCT00007345|O1|Outcome|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
1262460|NCT00007345|E2|Reported Event|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
1262461|NCT00007345|E1|Reported Event|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
1262462|NCT00006916|B1|Baseline|Radiation Therapy Followed by Bleomycin Via Ommaya Reservoir|60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression.
1262463|NCT00006916|P1|Participant Flow|Radiation Therapy Followed by Bleomycin Via Ommaya Reservoir|60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression.
1262464|NCT00006916|O1|Outcome|Radiation Therapy Followed by Bleomycin Via Ommaya Reservoir|60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression.
1262465|NCT00006916|E1|Reported Event|Radiation Therapy Followed by Bleomycin Via Ommaya Reservoir|60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression.
1262466|NCT00006903|B3|Baseline|Total|Total of all reporting groups
1262467|NCT00006903|B2|Baseline|Estrogen Receptor Positive|Estrogen Receptor Postive, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy
1262468|NCT00006903|B1|Baseline|Estrogen Receptor Negative|Estrogen Receptor Negative, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy
1262721|NCT00006392|O3|Outcome|Combination|Vitamin E + selenium
1262469|NCT00006903|P3|Participant Flow|Estrogen Receptor Positive|Estrogen Receptor Postive, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy
1262470|NCT00006903|P2|Participant Flow|Estrogen Receptor Negative|Estrogen Receptor Negative, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy
1262471|NCT00006903|P1|Participant Flow|Ineligible|Not eligible
1262472|NCT00006903|O2|Outcome|Estrogen Receptor Positive|Estrogen Receptor Postive, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy
1262473|NCT00006903|O1|Outcome|Estrogen Receptor Negative|Estrogen Receptor Negative, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy
1262474|NCT00006903|E1|Reported Event|Faslodex|"Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy.~Includes both Estrogen Receptor Positive and Estrogen Receptor Negative participants."
1262475|NCT00006721|B4|Baseline|Total|Total of all reporting groups
1262476|NCT00006721|B3|Baseline|CHOP Only|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. (Arm I closed to accrual as of 12/15/02)
1262477|NCT00006721|B2|Baseline|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
1262478|NCT00006721|B1|Baseline|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
1262479|NCT00006721|P3|Participant Flow|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
1262480|NCT00006721|P2|Participant Flow|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
1262481|NCT00006721|P1|Participant Flow|CHOP Only|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. (Arm I closed to accrual as of 12/15/02)
1262482|NCT00006721|O2|Outcome|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
1262483|NCT00006721|O1|Outcome|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
1262484|NCT00006721|O2|Outcome|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
1262485|NCT00006721|O1|Outcome|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
1262486|NCT00006721|O2|Outcome|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
1262487|NCT00006721|O1|Outcome|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
1262488|NCT00006721|O3|Outcome|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
1262489|NCT00006721|O2|Outcome|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
1262508|NCT00006604|P15|Participant Flow|Group 7: ATV Capsule (205mg/m^2) + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~Note: This is the final recommended dose for this group."
1262490|NCT00006721|O1|Outcome|CHOP Only|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6 courses in the abs ence of disease progression or unacceptable toxicity. (Arm I closed to accrual as of 12/15/02)
1262491|NCT00006721|O2|Outcome|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
1262492|NCT00006721|O1|Outcome|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
1262493|NCT00006721|O2|Outcome|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
1262494|NCT00006721|O1|Outcome|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
1262495|NCT00006721|E3|Reported Event|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
1262496|NCT00006721|E2|Reported Event|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
1262497|NCT00006721|E1|Reported Event|CHOP Only|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. (Arm I closed to accrual as of 12/15/02)
1262498|NCT00006604|B8|Baseline|Total|Total of all reporting groups
1262499|NCT00006604|B7|Baseline|Step I: Group 8 (ATV Final Dose: 205mg/m^2 Capsule + RTV)|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
1262500|NCT00006604|B6|Baseline|Step I: Group 7 (ATV Final Dose: 205mg/m^2 Capsule + RTV)|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
1262501|NCT00006604|B5|Baseline|Step I: Group 6 (ATV Final Dose: 310mg/m^2 Powder + RTV)|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262502|NCT00006604|B4|Baseline|Step I: Group 5a (ATV Final Dose: 310mg/m^2 Powder + RTV)|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262503|NCT00006604|B3|Baseline|Step I: Group 5 (ATV Final Dose: 310mg/m^2 Powder + RTV)|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262504|NCT00006604|B2|Baseline|Step I: Group 4 (ATV Final Dose: 620mg/m^2 Capsule)|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
1262505|NCT00006604|B1|Baseline|Step I: Group 3 (ATV Final Dose: 520mg/m^2 Capsule)|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
1262506|NCT00006604|P17|Participant Flow|Group 8: ATV Capsule (205mg/m^2) + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~Note: This is the final recommended dose for this group."
1262507|NCT00006604|P16|Participant Flow|Group 8: ATV Capsule (310mg/m^2) + RTV|Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
1262509|NCT00006604|P14|Participant Flow|Group 7: ATV Capsule (310mg/m^2) + RTV|Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
1262510|NCT00006604|P13|Participant Flow|Group 6: ATV Powder (310mg/m^2) + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~Note: This is the final recommended dose for this group."
1262511|NCT00006604|P12|Participant Flow|Group 5a: ATV Powder (310mg/m^2) + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~Note: This is the final recommended dose for this group."
1262512|NCT00006604|P11|Participant Flow|Group 5: ATV Powder (310mg/m^2) + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~Note: This is the final recommended dose for this group."
1262513|NCT00006604|P10|Participant Flow|Group 4: ATV Capsule (620mg/m^2)|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~Note: This is the final recommended dose for this group."
1262514|NCT00006604|P9|Participant Flow|Group 4: ATV Capsule (520mg/m^2)|Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.
1262515|NCT00006604|P8|Participant Flow|Group 4: ATV Capsule (310mg/m^2)|Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.
1262516|NCT00006604|P7|Participant Flow|Group 3: ATV Capsule (520mg/m^2)|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~Note: This is the final recommended dose for this group."
1262517|NCT00006604|P6|Participant Flow|Group 3: ATV Capsule (415mg/m^2)|Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.
1262518|NCT00006604|P5|Participant Flow|Group 3: ATV Capsule (310mg/m^2)|Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They will received ATV (capsule) and two NRTIs.
1262519|NCT00006604|P4|Participant Flow|Group 2: ATV Powder (620mg/m^2)|Group 2 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder) and two NRTIs.
1262520|NCT00006604|P3|Participant Flow|Group 2: ATV Powder (310mg/m^2)|Group 2 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder) and two NRTIs.
1262521|NCT00006604|P2|Participant Flow|Group 1: ATV Dose: Powder (620mg/m^2)|Group 1 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder) and two NRTIs.
1262522|NCT00006604|P1|Participant Flow|Group 1: ATV Dose: Powder (310mg/m^2)|Group 1 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder) and two NRTIs.
1262523|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
1262524|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
1262525|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262526|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262527|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262528|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
1262529|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
1262530|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
1262722|NCT00006392|O2|Outcome|Selenium|Selenium + matching placebo for vitamin E
1262531|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
1262532|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262533|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262534|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262535|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
1262536|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
1262537|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
1262538|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
1262539|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262540|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262541|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262542|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
1262543|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
1262544|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
1262632|NCT00006604|E3|Reported Event|Group 5: ATV 310mg/m^2 Powder + RTV|"91 days to 2 years of age (less than or exactly 730 days.~ATV powder + ritonavir + 2 NRTIs~Note: This is the final recommended dose for this group."
1262723|NCT00006392|O1|Outcome|Vitamin E|Vitamin E + matching placebo for selenium
1262545|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended: 205mg/m^2"
1262546|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262547|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262548|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262549|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
1262550|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
1262551|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
1262552|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
1262553|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262554|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262555|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262556|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
1262557|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
1262558|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
1262633|NCT00006604|E2|Reported Event|Group 4: ATV 620mg/m^2 Capsule|"13 years and 1 day to 21 (not including the 22nd birthday) years of age.~ATV capsule + 2 NRTIs~Note: This is the final recommended dose for this group."
1262724|NCT00006392|O4|Outcome|Placebo|Matching placebo for vitamin E + matching placebo for selenium
1262559|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
1262560|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262561|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262562|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262563|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
1262564|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
1262565|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
1262566|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
1262567|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m2"
1262568|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262569|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262570|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
1262571|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
1262572|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
1262634|NCT00006604|E1|Reported Event|Group 3: ATV 520mg/m^2 Capsule|"2 years and 1 day (731 days or more) to 13 years of age.~ATV capsule + 2 NRTIs~Note: This is the final recommended dose for this group."
1262635|NCT00006489|B5|Baseline|Total|Total of all reporting groups
1262573|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
1262574|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262575|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262576|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended: 310mg/m^2"
1262577|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
1262578|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2 Capsule"
1262579|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
1262580|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
1262581|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262582|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262583|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262584|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
1262585|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
1262586|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
1262636|NCT00006489|B4|Baseline|Placebo + Supportive Counseling|"Placebo alone~Placebo: Pill Placebo daily dosing 24 weeks"
1262725|NCT00006392|O3|Outcome|Combination|Vitamin E + selenium
1262726|NCT00006392|O2|Outcome|Selenium|Selenium + matching placebo for vitamin E
1262587|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
1262588|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262589|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262590|NCT00006604|O3|Outcome|Step I: Group 5: ATV 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262591|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
1262592|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
1262593|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
1262594|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
1262595|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262596|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262597|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262598|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
1262599|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
1262600|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
1262637|NCT00006489|B3|Baseline|Placebo + CBT (Prolonged Exposure Therapy)|"Placebo with CBT for PTSD~Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week"
1262727|NCT00006392|O1|Outcome|Vitamin E|Vitamin E + matching placebo for selenium
1262601|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
1262602|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262603|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262604|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262605|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
1262606|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
1262607|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
1262608|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended: 205mg/m^2"
1262609|NCT00006604|O5|Outcome|Step I: Group 6 : ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262610|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262611|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262612|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
1262613|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
1262614|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
1262638|NCT00006489|B2|Baseline|Naltrexone + CBT (Prolonged Exposure Therapy)|"Naltrexone with CBT for PTSD~Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week~Naltrexone: Daily dosing 100 mg for 24 weeks"
1262615|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
1262616|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262617|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262618|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262619|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
1262620|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
1262621|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
1262622|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
1262623|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262624|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended: 310mg/m^2"
1262625|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
1262626|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
1262627|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
1262628|NCT00006604|E7|Reported Event|Group 5A: ATV 310mg/m^2 Powder + RTV|"91 to 180 days of age.~ATV powder + ritonavir + 2 NRTIs~Note: This is the final recommended dose for this group."
1262629|NCT00006604|E6|Reported Event|Group 8: ATV 205mg/m^2 Capsule + RTV|"13 years and 1 day to 21 (not including the 22nd birthday) years of age.~ATV capsule + ritonavir + 2 NRTIs~Note: This is the final recommended dose for this group."
1262630|NCT00006604|E5|Reported Event|Group 7: ATV 205mg/m^2 Capsule + RTV|"2 years and 1 day (731 days or more) to 13 years of age.~ATV capsule + ritonavir + 2 NRTIs~Note: This is the final recommended dose for this group."
1262631|NCT00006604|E4|Reported Event|Group 6: ATV 310mg/m^2 Powder + RTV|"2 years and 1 day (731 days or more) to 13 years of age.~ATV powder + ritonavir + 2 NRTIs~Note: This is the final recommended dose for this group."
1262641|NCT00006489|P3|Participant Flow|Placebo + CBT (Prolonged Exposure Therapy)|"Placebo with CBT for PTSD~Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week"
1262642|NCT00006489|P2|Participant Flow|Naltrexone + CBT (Prolonged Exposure Therapy)|"Naltrexone with CBT for PTSD~Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week~Naltrexone: Daily dosing 100 mg for 24 weeks"
1262643|NCT00006489|P1|Participant Flow|Naltrexone + Supportive Counseling|"Naltrexone alone~Naltrexone: Daily dosing 100 mg for 24 weeks"
1262644|NCT00006489|O4|Outcome|Placebo + Supportive Counseling|"Placebo alone~Placebo: Pill Placebo daily dosing 24 weeks"
1262645|NCT00006489|O3|Outcome|Placebo + CBT (Prolonged Exposure Therapy)|"Placebo with CBT for PTSD~Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week"
1262646|NCT00006489|O2|Outcome|Naltrexone + CBT (Prolonged Exposure Therapy)|"Naltrexone with CBT for PTSD~Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week~Naltrexone: Daily dosing 100 mg for 24 weeks"
1262647|NCT00006489|O1|Outcome|Naltrexone + Supportive Counseling|"Naltrexone alone~Naltrexone: Daily dosing 100 mg for 24 weeks"
1262648|NCT00006489|O4|Outcome|Placebo + Supportive Counseling|"Placebo alone~Placebo: Pill Placebo daily dosing 24 weeks"
1262649|NCT00006489|O3|Outcome|Placebo + CBT (Prolonged Exposure Therapy)|"Placebo with CBT for PTSD~Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week"
1262650|NCT00006489|O2|Outcome|Naltrexone + CBT (Prolonged Exposure Therapy)|"Naltrexone with CBT for PTSD~Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week~Naltrexone: Daily dosing 100 mg for 24 weeks"
1262651|NCT00006489|O1|Outcome|Naltrexone + Supportive Counseling|"Naltrexone alone~Naltrexone: Daily dosing 100 mg for 24 weeks"
1262652|NCT00006489|O4|Outcome|Placebo + Supportive Counseling|"Placebo alone~Placebo: Pill Placebo daily dosing 24 weeks"
1262653|NCT00006489|O3|Outcome|Placebo + CBT (Prolonged Exposure Therapy)|"Placebo with CBT for PTSD~Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week"
1262654|NCT00006489|O2|Outcome|Naltrexone + CBT (Prolonged Exposure Therapy)|"Naltrexone with CBT for PTSD~Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week~Naltrexone: Daily dosing 100 mg for 24 weeks"
1262655|NCT00006489|O1|Outcome|Naltrexone + Supportive Counseling|"Naltrexone alone~Naltrexone: Daily dosing 100 mg for 24 weeks"
1262656|NCT00006489|E4|Reported Event|Placebo + Supportive Counseling|"Placebo alone~Placebo: Pill Placebo daily dosing 24 weeks"
1262657|NCT00006489|E3|Reported Event|Placebo + CBT (Prolonged Exposure Therapy)|"Placebo with CBT for PTSD~Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week"
1262658|NCT00006489|E2|Reported Event|Naltrexone + CBT (Prolonged Exposure Therapy)|"Naltrexone with CBT for PTSD~Cognitive-Behavioral Therapy: Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week~Naltrexone: Daily dosing 100 mg for 24 weeks"
1262659|NCT00006489|E1|Reported Event|Naltrexone + Supportive Counseling|"Naltrexone alone~Naltrexone: Daily dosing 100 mg for 24 weeks"
1262660|NCT00006478|B1|Baseline|Vaccine Therapy|vaccination to beging at day +100 or 6 months after hematopoietic stem cell transplantation. The vaccine will be given every 4 weeks for 7 consecutive doses and will include Idiotype + KLH along with the adjuvant, GMCSF
1262661|NCT00006478|P1|Participant Flow|Vaccine Therapy|vaccination to beging at day +100 or 6 months after hematopoietic stem cell transplantation. The vaccine will be given every 4 weeks for 7 consecutive doses and will include Idiotype + KLH along with the adjuvant, GMCSF
1262662|NCT00006478|O1|Outcome|Vaccine Therapy|vaccination to beging at day +100 or 6 months after hematopoietic stem cell transplantation. The vaccine will be given every 4 weeks for 7 consecutive doses and will include Idiotype + KLH along with the adjuvant, GMCSF
1262663|NCT00006478|E1|Reported Event|Vaccine Therapy|vaccination to beging at day +100 or 6 months after hematopoietic stem cell transplantation. The vaccine will be given every 4 weeks for 7 consecutive doses and will include Idiotype + KLH along with the adjuvant, GMCSF
1262664|NCT00006409|B7|Baseline|Total|Total of all reporting groups
1262665|NCT00006409|B6|Baseline|8th-grade/2006 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
1262666|NCT00006409|B5|Baseline|8th-grade/2006 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
1262667|NCT00006409|B4|Baseline|8th-grade/2005 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
1262668|NCT00006409|B3|Baseline|8th-grade/2005 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
1262669|NCT00006409|B2|Baseline|6th-grade/2003 - Control|Cross-sectional sample of 6th-grade girls in schools that were randomized to not receive the intervention (data collected at baseline)
1262670|NCT00006409|B1|Baseline|6th-grade/2003 - Intervention|Cross-sectional sample of 6th-grade girls in schools that were randomized to receive the intervention (data collected at baseline)
1262671|NCT00006409|P6|Participant Flow|8th-grade/2006 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
1262672|NCT00006409|P5|Participant Flow|8th-grade/2006 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
1262673|NCT00006409|P4|Participant Flow|8th-grade/2005 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
1262674|NCT00006409|P3|Participant Flow|8th-grade/2005 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
1262675|NCT00006409|P2|Participant Flow|6th-grade/2003 - Control|Cross-sectional sample of 6th-grade girls in schools that were randomized to not receive the intervention (data collected at baseline)
1262676|NCT00006409|P1|Participant Flow|6th-grade/2003 - Intervention|Cross-sectional sample of 6th-grade girls in schools that were randomized to receive the intervention (data collected at baseline)
1262677|NCT00006409|O6|Outcome|8th-grade/2006 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
1262678|NCT00006409|O5|Outcome|8th-grade/2006 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
1262679|NCT00006409|O4|Outcome|8th-grade/2005 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
1262680|NCT00006409|O3|Outcome|8th-grade/2005 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
1262681|NCT00006409|O2|Outcome|6th-grade/2003 - Control|Cross-sectional sample of 6th-grade girls in schools that were randomized to not receive the intervention (data collected at baseline)
1262682|NCT00006409|O1|Outcome|6th-grade/2003 - Intervention|Cross-sectional sample of 6th-grade girls in schools that were randomized to receive the intervention (data collected at baseline)
1262683|NCT00006409|O6|Outcome|8th-grade/2006 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
1262684|NCT00006409|O5|Outcome|8th-grade/2006 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
1262685|NCT00006409|O4|Outcome|8th-grade/2005 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
1262686|NCT00006409|O3|Outcome|8th-grade/2005 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
1262687|NCT00006409|O2|Outcome|6th-grade/2003 - Control|Cross-sectional sample of 6th-grade girls in schools that were randomized to not receive the intervention (data collected at baseline)
1262688|NCT00006409|O1|Outcome|6th-grade/2003 - Intervention|Cross-sectional sample of 6th-grade girls in schools that were randomized to receive the intervention (data collected at baseline)
1262689|NCT00006409|E6|Reported Event|8th-grade/2006 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
1262690|NCT00006409|E5|Reported Event|8th-grade/2006 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
1262691|NCT00006409|E4|Reported Event|8th-grade/2005 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
1262692|NCT00006409|E3|Reported Event|8th-grade/2005 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
1262693|NCT00006409|E2|Reported Event|6th-grade/2003 - Control|Cross-sectional sample of 6th-grade girls in schools that were randomized to not receive the intervention (data collected at baseline)
1262694|NCT00006409|E1|Reported Event|6th-grade/2003 - Intervention|Cross-sectional sample of 6th-grade girls in schools that were randomized to receive the intervention (data collected at baseline)
1262695|NCT00006392|B5|Baseline|Total|Total of all reporting groups
1262696|NCT00006392|B4|Baseline|Placebo|Matching placebo for vitamin E + matching placebo for selenium
1262697|NCT00006392|B3|Baseline|Combination|Vitamin E + selenium
1262698|NCT00006392|B2|Baseline|Selenium|Selenium + matching placebo for vitamin E
1262699|NCT00006392|B1|Baseline|Vitamin E|Vitamin E + matching placebo for selenium
1262700|NCT00006392|P4|Participant Flow|Placebo|Matching placebo for vitamin E + matching placebo for selenium
1262701|NCT00006392|P3|Participant Flow|Combination|Vitamin E + selenium
1262702|NCT00006392|P2|Participant Flow|Selenium|Selenium + matching placebo for vitamin E
1262703|NCT00006392|P1|Participant Flow|Vitamin E|Vitamin E + matching placebo for selenium
1262704|NCT00006392|O4|Outcome|Placebo|Matching placebo for vitamin E + matching placebo for selenium
1262705|NCT00006392|O3|Outcome|Combination|Vitamin E + selenium
1262706|NCT00006392|O2|Outcome|Selenium|Selenium + matching placebo for vitamin E
1262707|NCT00006392|O1|Outcome|Vitamin E|Vitamin E + matching placebo for selenium
1262708|NCT00006392|O4|Outcome|Placebo|Matching placebo for vitamin E + matching placebo for selenium
1262709|NCT00006392|O3|Outcome|Combination|Vitamin E + selenium
1262710|NCT00006392|O2|Outcome|Selenium|Selenium + matching placebo for vitamin E
1262711|NCT00006392|O1|Outcome|Vitamin E|Vitamin E + matching placebo for selenium
1262712|NCT00006392|O4|Outcome|Placebo|Matching placebo for vitamin E + matching placebo for selenium
1262713|NCT00006392|O3|Outcome|Combination|Vitamin E + selenium
1262714|NCT00006392|O2|Outcome|Selenium|Selenium + matching placebo for vitamin E
1262715|NCT00006392|O1|Outcome|Vitamin E|Vitamin E + matching placebo for selenium
1262716|NCT00006392|O4|Outcome|Placebo|Matching placebo for vitamin E + matching placebo for selenium
1262717|NCT00006392|O3|Outcome|Combination|Vitamin E + selenium
1262731|NCT00006392|E1|Reported Event|Selenium Alone|Selenium + placebo for vitamin E
1262732|NCT00006389|B1|Baseline|Treatment|"Patients received byrostatin-1 45µg/m2/day as a 72 hour intravenous infusion followed by a 1-hour infusion of cisplatin 50 mg/m2 on day 4 immediately at the bryostatin-1 infusion, administered every three weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.~bryostatin 1: Given IV~cisplatin: Given IV~laboratory biomarker analysis: Correlative studies"
1262733|NCT00006389|P1|Participant Flow|Treatment|"Patients received byrostatin-1 45µg/m2/day as a 72 hour intravenous infusion followed by a 1-hour infusion of cisplatin 50 mg/m2 on day 4 immediately at the bryostatin-1 infusion, administered every three weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.~bryostatin 1: Given IV~cisplatin: Given IV~laboratory biomarker analysis: Correlative studies"
1262734|NCT00006389|O1|Outcome|Treatment|"Patients receive bryostatin 1 IV over 72 hours on days 1-3 followed by cisplatin IV over 1 hour on day 4. Treatment repeats every 3 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.~bryostatin 1: Given IV~cisplatin: Given IV~laboratory biomarker analysis: Correlative studies"
1262735|NCT00006389|O1|Outcome|Treatment|"Patients receive bryostatin 1 IV over 72 hours on days 1-3 followed by cisplatin IV over 1 hour on day 4. Treatment repeats every 3 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.~bryostatin 1: Given IV~cisplatin: Given IV~laboratory biomarker analysis: Correlative studies"
1262736|NCT00006389|O1|Outcome|Treatment|"Patients received byrostatin-1 45µg/m2/day as a 72 hour intravenous infusion followed by a 1-hour infusion of cisplatin 50 mg/m2 on day 4 immediately at the bryostatin-1 infusion, administered every three weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.~bryostatin 1: Given IV~cisplatin: Given IV~laboratory biomarker analysis: Correlative studies"
1262737|NCT00006389|E1|Reported Event|Treatment|"Patients received byrostatin-1 45µg/m2/day as a 72 hour intravenous infusion followed by a 1-hour infusion of cisplatin 50 mg/m2 on day 4 immediately at the bryostatin-1 infusion, administered every three weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.~bryostatin 1: Given IV~cisplatin: Given IV~laboratory biomarker analysis: Correlative studies"
1262738|NCT00006305|B5|Baseline|Total|Total of all reporting groups
1262739|NCT00006305|B4|Baseline|Medical Therapy and Insulin Sensitizing (IS)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy
1262740|NCT00006305|B3|Baseline|Medical Therapy and Insulin Providing (IP)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy
1262741|NCT00006305|B2|Baseline|Revascularization and Insulin Sensitizing (IS)|Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy
1262742|NCT00006305|B1|Baseline|Revascularization and Insulin Providing (IP)|Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy
1262743|NCT00006305|P4|Participant Flow|Medical Therapy and Insulin Sensitizing (IS)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy
1262744|NCT00006305|P3|Participant Flow|Medical Therapy and Insulin Providing (IP)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy
1262745|NCT00006305|P2|Participant Flow|Revascularization and Insulin Sensitizing (IS)|Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy
1262746|NCT00006305|P1|Participant Flow|Revascularization and Insulin Providing (IP)|Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy
1262747|NCT00006305|O4|Outcome|Medical Therapy and Insulin Sensitizing (IS)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy
1262748|NCT00006305|O3|Outcome|Medical Therapy and Insulin Providing (IP)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy
1262749|NCT00006305|O2|Outcome|Revascularization and Insulin Sensitizing (IS)|Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy
1262750|NCT00006305|O1|Outcome|Revascularization and Insulin Providing (IP)|Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy
1262751|NCT00006305|O4|Outcome|Medical Therapy and Insulin Sensitizing (IS)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy
1262752|NCT00006305|O3|Outcome|Medical Therapy and Insulin Providing (IP)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy
1262753|NCT00006305|O2|Outcome|Revascularization and Insulin Sensitizing (IS)|Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy
1262754|NCT00006305|O1|Outcome|Revascularization and Insulin Providing (IP)|Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy
1262755|NCT00006305|E4|Reported Event|Medical Therapy and Insulin Sensitizing (IS)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy
1262756|NCT00006305|E3|Reported Event|Medical Therapy and Insulin Providing (IP)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy
1262757|NCT00006305|E2|Reported Event|Revascularization and Insulin Sensitizing (IS)|Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy
1262758|NCT00006305|E1|Reported Event|Revascularization and Insulin Providing (IP)|Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy
1262759|NCT00006289|B3|Baseline|Total|Total of all reporting groups
1262760|NCT00006289|B2|Baseline|Neurotropin First, Then Placebo|Receive Neurotropin 4 tabs b.i.d. for 5 weeks and then Placebo 4 tabs b.i.d. for 5 weeks (after at least 1 week washout period)
1262856|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
1262761|NCT00006289|B1|Baseline|Placebo First, Then Neurotropin|Receive Placebo 4 tabs b.i.d. for 5 weeks and then Neurotropin 4 tabs b.i.d. for 5 weeks (after at least 1 week washout period)
1262762|NCT00006289|P2|Participant Flow|Neurotropin First, Then Placebo|Receive Neurotropin b.i.d. for 5 weeks and then the placebo b.i.d. for 5 weeks (after at least 1 week washout period)
1262763|NCT00006289|P1|Participant Flow|Placebo First, Then Neurotropin|Receive the placebo b.i.d. for 5 weeks and then Neurotropin b.i.d. for 5 weeks (after at least 1 week washout period)
1262764|NCT00006289|O4|Outcome|MPQ After Placebo Treatment Second in G-2|"This group received placebo 4 tabs b.i.d. for 5 weeks after at least 1 week washout period following the first 5 week interval on Neurotropin. MPQ was determined at the end of the 5 week-treatment of placebo."
1262765|NCT00006289|O3|Outcome|MPQ After Neurotropin Treatment First in G-2|This group received Neurotropin 4 tabs b.i.d. for 5 weeks first. MPQ was determined at the end of the 5 week-treatment.
1262766|NCT00006289|O2|Outcome|MPQ After Neurotropin Treatment Second in G-1|"This group received Neurotropin 4 tabs b.i.d. for 5 weeks after at least 1 week washout period following the first 5 week interval on placebo. MPQ was determined at the end of the 5 week-treatment of Neurotropin."
1262767|NCT00006289|O1|Outcome|MPQ After Placebo Treatment First in G-1|This group received placebo 4 tabs b.i.d. for 5 weeks first. MPQ was determined at the end of the 5 week-treatment.
1262768|NCT00006289|O4|Outcome|NRS After Placebo Treatment Second in G-2|"This group received placebo 4 tabs b.i.d. for 5 weeks after at least 1 week washout period following the first 5 week interval on Neurotropin. NRS was determined at the end of the 5 week-treatment of placebo."
1262769|NCT00006289|O3|Outcome|NRS After Neurotropin Treatment First in G-2|This group received Neurotropin 4 tabs b.i.d. for 5 weeks first. NRS was determined at the end of the 5 week-treatment.
1262770|NCT00006289|O2|Outcome|NRS After Neurotropin Treatment Second in G-1|"This group received Neurotropin 4 tabs b.i.d. for 5 weeks after at least 1 week washout period following the first 5 week interval on placebo. NRS was determined at the end of the 5 week-treatment of Neurotropin."
1262771|NCT00006289|O1|Outcome|NRS After Placebo Treatment First in G-1|This group received placebo 4 tabs b.i.d. for 5 weeks first. NRS was determined at the end of the 5 week-treatment.
1262772|NCT00006289|O4|Outcome|VAS After Placebo Treatment Second in G-2|"This group received placebo 4 tabs b.i.d. for 5 weeks after at least 1 week washout period following the first 5 week interval on Neurotropin. VAS was determined at the end of the 5 week-treatment of placebo."
1262773|NCT00006289|O3|Outcome|VAS After Neurotropin Treatment First in G-2|This group received Neurotropin 4 tabs b.i.d. for 5 weeks first. VAS was determined at the end of the 5 week-treatment.
1262774|NCT00006289|O2|Outcome|VAS After Neurotropin Treatment Second in G-1|"This group received Neurotropin 4 tabs b.i.d. for 5 weeks after at least 1 week washout period following the first 5 week interval on placebo. VAS was determined at the end of the 5 week-treatment of Neurotropin."
1262775|NCT00006289|O1|Outcome|VAS After Placebo Treatment First in G-1|This group received placebo 4 tabs b.i.d. for 5 weeks first. VAS was determined at the end of the 5 week-treatment.
1262776|NCT00006289|E2|Reported Event|Neurotropin First, Then Placebo|Receive Neurotropin b.i.d. for 5 weeks and then the placebo b.i.d. for 5 weeks (after at least 1 week washout period)
1262777|NCT00006289|E1|Reported Event|Placebo First, Then Neurotropin|Receive the placebo b.i.d. for 5 weeks and then Neurotropin b.i.d. for 5 weeks (after at least 1 week washout period)
1262778|NCT00006244|B1|Baseline|Immunotherapy Treatment|"Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.~melphalan: Given IV~recombinant interferon alfa: Given SC~aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion~in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion"
1262779|NCT00006244|P1|Participant Flow|Immunotherapy Treatment|"Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.~melphalan: Given IV~recombinant interferon alfa: Given SC~aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion~in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion"
1262780|NCT00006244|O1|Outcome|Immunotherapy Treatment|"Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.~melphalan: Given IV~recombinant interferon alfa: Given SC~aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion~in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion"
1262781|NCT00006244|O1|Outcome|Immunotherapy Treatment|"Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.~melphalan: Given IV~recombinant interferon alfa: Given SC~aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion~in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion"
1262805|NCT00006184|O2|Outcome|Donor - Vaccination Generation Group|3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination
1262857|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
1262782|NCT00006244|O1|Outcome|Immunotherapy Treatment|"Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.~melphalan: Given IV~recombinant interferon alfa: Given SC~aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion~in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion"
1262783|NCT00006244|O1|Outcome|Immunotherapy Treatment|"Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.~melphalan: Given IV~recombinant interferon alfa: Given SC~aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion~in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion"
1262784|NCT00006244|O1|Outcome|Immunotherapy Treatment|"Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.~melphalan: Given IV~recombinant interferon alfa: Given SC~aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion~in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion"
1262785|NCT00006244|O1|Outcome|Immunotherapy Treatment|"Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.~melphalan: Given IV~recombinant interferon alfa: Given SC~aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion~in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion"
1262786|NCT00006244|E1|Reported Event|Immunotherapy Treatment|"Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.~melphalan: Given IV~recombinant interferon alfa: Given SC~aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion~in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion"
1262787|NCT00006237|B3|Baseline|Total|Total of all reporting groups
1262788|NCT00006237|B2|Baseline|Biochemotherapy|cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
1262789|NCT00006237|B1|Baseline|Interferon|interferon alfa
1262790|NCT00006237|P2|Participant Flow|Biochemotherapy|cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
1262791|NCT00006237|P1|Participant Flow|Interferon|interferon alfa IV
1262792|NCT00006237|O2|Outcome|Biochemotherapy|Biochemotherapy
1262793|NCT00006237|O1|Outcome|Interferon|Interferon
1262794|NCT00006237|O2|Outcome|Biochemotherapy|cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
1262795|NCT00006237|O1|Outcome|Interferon|interferon alfa
1262796|NCT00006237|O2|Outcome|Biochemotherapy|cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
1262797|NCT00006237|O1|Outcome|Interferon|interferon alfa IV on days 1-5 of weeks 1-4 followed by interferon alfa subcutaneously (SC) on days 1, 3, and 5 of weeks 5-52 in the absence of disease progression or unacceptable toxicity.
1262798|NCT00006237|E2|Reported Event|Biochemotherapy|cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
1262799|NCT00006237|E1|Reported Event|Interferon|interferon alfa
1262800|NCT00006184|B3|Baseline|Total|Total of all reporting groups
1262801|NCT00006184|B2|Baseline|Donor - Vaccination Generation Group|3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination
1262802|NCT00006184|B1|Baseline|Recipient - Chemotherapy Group|Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and GCSF followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
1262803|NCT00006184|P2|Participant Flow|Donor - Vaccination Generation Group|3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (Anti-idiotype-keyhole limpet hemocyanin) (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination
1262804|NCT00006184|P1|Participant Flow|Recipient - Chemotherapy Group|Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and granulocyte colony stimulating factor ( GCSF) followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
1262806|NCT00006184|O1|Outcome|Recipient - Chemotherapy Group|Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and GCSF followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
1262807|NCT00006184|O1|Outcome|Recipient - Chemotherapy Group|Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and GCSF followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
1262808|NCT00006184|E2|Reported Event|Donor - Vaccination Generation Group|3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination
1262809|NCT00006184|E1|Reported Event|Recipient - Chemotherapy Group|Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and GCSF followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
1262810|NCT00006178|B1|Baseline|Sirolimus Monotherapy|
1262811|NCT00006178|P1|Participant Flow|Sirolimus Monotherapy|
1262812|NCT00006178|O1|Outcome|Sirolimus Monotherapy|
1262813|NCT00006178|O1|Outcome|Sirolimus Monotherapy|
1262814|NCT00006178|O1|Outcome|Sirolimus Monotherapy|
1262815|NCT00006178|O1|Outcome|Sirolimus Monotherapy|
1262816|NCT00006178|E1|Reported Event|Sirolimus Monotherapy|
1262817|NCT00006170|B5|Baseline|Total|Total of all reporting groups
1262818|NCT00006170|B4|Baseline|SS+P|An approach was taken to combine standard cessation therapy with added discussion of smoking topics but no specific weight focus and pharmacotherapy. This group took a placebo instead of the bupropion.
1262819|NCT00006170|B3|Baseline|SS+B|An approach was taken to combine standard cessation therapy with added discussion of smoking topics but no specific weight focus and pharmacotherapy. This group took bupropion, a widely used, efficacious smoking cessation agent.
1262820|NCT00006170|B2|Baseline|WC+P|An approach was taken to combine cognitive behavioral therapy and pharmacotherapy to women who had weight concerns after cessation. This group took a placebo instead of bupropion.
1262821|NCT00006170|B1|Baseline|WC+B|An approach was taken to combine cognitive behavioral therapy and pharmacotherapy to women who had weight concerns after cessation. This group took bupropion, a widely used, efficacious smoking cessation agent.
1262822|NCT00006170|P4|Participant Flow|Social Support + Placebo (SS+P)|An approach was taken to combine standard cessation therapy with added discussion of smoking topics but no specific weight focus and pharmacotherapy. This group took a placebo instead of the bupropion.
1262823|NCT00006170|P3|Participant Flow|Social Support + Bupropion (SS+B)|An approach was taken to combine standard cessation therapy with added discussion of smoking topics but no specific weight focus and pharmacotherapy. This group took bupropion, a widely used, efficacious smoking cessation agent.
1262824|NCT00006170|P2|Participant Flow|Weight Concerns + Placebo (WC+P)|An approach was taken to combine cognitive behavioral therapy and pharmacotherapy to women who had weight concerns after cessation. This group took a placebo instead of the bupropion.
1262825|NCT00006170|P1|Participant Flow|Weight Concerns + Bupropion (WC+B)|An approach was taken to combine cognitive behavioral therapy and pharmacotherapy to women who had weight concerns after cessation. This group took bupropion, a widely used, efficacious smoking cessation agent.
1262826|NCT00006170|O4|Outcome|SS+P|
1262827|NCT00006170|O3|Outcome|SS+B|
1262828|NCT00006170|O2|Outcome|WC+P|
1262829|NCT00006170|O1|Outcome|WC+B|
1262830|NCT00006170|O4|Outcome|SS+P|
1262831|NCT00006170|O3|Outcome|SS+B|
1262832|NCT00006170|O2|Outcome|WC+P|
1262833|NCT00006170|O1|Outcome|WC+B|
1262834|NCT00006170|O4|Outcome|SS+P|
1262835|NCT00006170|O3|Outcome|SS+B|
1262836|NCT00006170|O2|Outcome|WC+P|
1262837|NCT00006170|O1|Outcome|WC+B|
1262838|NCT00006170|E4|Reported Event|SS+P|
1262839|NCT00006170|E3|Reported Event|SS+B|
1262840|NCT00006170|E2|Reported Event|WC+P|
1262841|NCT00006170|E1|Reported Event|WC+B|
1262842|NCT00006164|B3|Baseline|Total|Total of all reporting groups
1262843|NCT00006164|B2|Baseline|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
1262844|NCT00006164|B1|Baseline|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
1262845|NCT00006164|P2|Participant Flow|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
1262846|NCT00006164|P1|Participant Flow|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
1262847|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
1262848|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
1262849|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
1262850|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
1262851|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
1262852|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
1262853|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
1262854|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
1262855|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
1262858|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
1262859|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
1262860|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
1262861|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
1262862|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
1262863|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
1262864|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
1262865|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
1262866|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
1262867|NCT00006164|E2|Reported Event|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
1262868|NCT00006164|E1|Reported Event|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
1262869|NCT00006156|B3|Baseline|Total|Total of all reporting groups
1262870|NCT00006156|B2|Baseline|Control|
1262871|NCT00006156|B1|Baseline|Drug - FSH|
1262872|NCT00006156|P2|Participant Flow|Control|
1262873|NCT00006156|P1|Participant Flow|Drug - FSH|
1262874|NCT00006156|O2|Outcome|Control|
1262875|NCT00006156|O1|Outcome|Drug - FSH|
1262876|NCT00006156|O2|Outcome|Control|
1262877|NCT00006156|O1|Outcome|Drug - FSH|
1262878|NCT00006156|E1|Reported Event|Adverse Events Not Collected|Adverse Events Not Collected
1262879|NCT00006151|B3|Baseline|Total|Total of all reporting groups
1262880|NCT00006151|B2|Baseline|Placebo Accu Drop Plus Counseling|Placebo product and systematic cigarette tapering plus counseling
1262881|NCT00006151|B1|Baseline|Accu Drop Plus Counseling|Active product and systematic cigarette tapering plus counseling.
1262882|NCT00006151|P2|Participant Flow|Placebo (PD&C)|The control condition (N=30) will be prescribed placebo Accu Drops (PD&C)
1262883|NCT00006151|P1|Participant Flow|Accu Drops (AD&C)|The experimental group (N=30) will be prescribed active Accu Drops (AD&C)
1262884|NCT00006151|O2|Outcome|Placebo Accu Drop Plus Counseling|Placebo product and systematic cigarette tapering plus counseling
1262885|NCT00006151|O1|Outcome|Accu Drop Plus Counseling|Active product and systematic cigarette tapering plus counseling.
1262886|NCT00006151|E2|Reported Event|Placebo (PD&C)|The control condition (N=30) will be prescribed placebo Accu Drops (PD&C)
1262887|NCT00006151|E1|Reported Event|Accu Drops (AD&C)|The experimental group (N=30) will be prescribed active Accu Drops (AD&C)
1262888|NCT00006011|B4|Baseline|Total|Total of all reporting groups
1262889|NCT00006011|B3|Baseline|Radiation (RT) Only|Tumor volume directed pelvic plus or minus para-aortic irradiation (plus or minus brachytherapy)
1262890|NCT00006011|B2|Baseline|Arm 2|"Treatment randomization following RT:~radiation followed by doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 day 1 paclitaxel 3-Hr 160 mg/m2 day 2 G-CSF 5 mcg/kg days 3-12"
1262891|NCT00006011|B1|Baseline|Arm 1|"Treatment randomization following RT.~radiation followed by doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 G-CSF 5mcg/kg Days 2-11"
1262892|NCT00006011|P3|Participant Flow|Radiation (RT) Only|Tumor volume directed pelvic plus or minus para-aortic irradiation (plus or minus brachytherapy)
1262893|NCT00006011|P2|Participant Flow|Arm 2|"Treatment randomization following RT:~radiation followed by doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 day 1 paclitaxel 3-Hr 160 mg/m2 day 2 G-CSF 5 mcg/kg days 3-12"
1262894|NCT00006011|P1|Participant Flow|Arm 1|"Treatment randomization following RT.~radiation followed by doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 G-CSF 5mcg/kg Days 2-11"
1262895|NCT00006011|O2|Outcome|Arm 2|"Treatment randomization following RT:~doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 day 1 paclitaxel 3-Hr 160 mg/m2 day 2 G-CSF 5 mcg/kg days 3-12"
1262896|NCT00006011|O1|Outcome|Arm 1|"Treatment randomization following RT.~doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 G-CSF 5mcg/kg Days 2-11"
1262897|NCT00006011|E2|Reported Event|Arm 2|"Treatment randomization following RT:~doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 day 1 paclitaxel 3-Hr 160 mg/m2 day 2 G-CSF 5 mcg/kg days 3-12"
1262898|NCT00006011|E1|Reported Event|Arm 1|"Treatment randomization following RT.~doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 G-CSF 5mcg/kg Days 2-11"
1262899|NCT00005957|B3|Baseline|Total|Total of all reporting groups
1262900|NCT00005957|B2|Baseline|Breast Radiation Plus Regional Radiation|"regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)~Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields."
1262901|NCT00005957|B1|Baseline|Standard Breast Irradiation|radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
1262902|NCT00005957|P2|Participant Flow|Breast Radiation Plus Regional Radiation|"regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)~Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields."
1262903|NCT00005957|P1|Participant Flow|Standard Breast Irradiation|radiation therapy: Standard Breast Irradiation - A dose of 5000 centigray (cGy) in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
1262967|NCT00005879|O2|Outcome|Arzoxifene|"LY353381, 20 mg daily~arzoxifene: one tablet daily"
1262968|NCT00005879|O1|Outcome|Placebo|"Placebo~Placebo: matched tablet dialy"
1262904|NCT00005957|O2|Outcome|Breast Radiation Plus Regional Radiation|"regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)~Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields."
1262905|NCT00005957|O1|Outcome|Standard Breast Irradiation|radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
1262906|NCT00005957|O2|Outcome|Breast Radiation Plus Regional Radiation|"regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)~Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields."
1262907|NCT00005957|O1|Outcome|Standard Breast Irradiation|radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
1262908|NCT00005957|E2|Reported Event|Breast Radiation Plus Regional Radiation|"regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)~Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields.~Analysis of adverse events were based on the 893 patients who actually received Breast Radiation plus regional radiation treatment. A total of 5 patients who were randomized to Standard Breast Irradiation and 888 patients who were randomized to Breast Radiation plus regional radiation actually received the Breast Radiation plus regional radiation treatment."
1262909|NCT00005957|E1|Reported Event|Standard Breast Irradiation|"radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.~Analysis of adverse events were based on the 927 patients who actually received Standard Breast Irradiation treatment. A total of 908 patients who were randomized to Standard Breast Irradiation and 19 patients who were randomized to Breast Radiation plus regional radiation actually received the Standard Breast Irradiation treatment."
1262910|NCT00005947|B3|Baseline|Total|Total of all reporting groups
1262911|NCT00005947|B2|Baseline|Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure.
1262912|NCT00005947|B1|Baseline|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.
1262913|NCT00005947|P2|Participant Flow|Placebo|"All subjects randomized to receive placebo.~Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals."
1262914|NCT00005947|P1|Participant Flow|Sipuleucel-T|"All subjects randomized to receive sipuleucel-T.~Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart."
1262915|NCT00005947|O2|Outcome|Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure.
1262916|NCT00005947|O1|Outcome|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.
1262917|NCT00005947|O2|Outcome|Placebo|All subjects randomized to receive placebo
1262918|NCT00005947|O1|Outcome|Sipuleucel-T|All subjects randomized to receive sipuleucel-T.
1262919|NCT00005947|E2|Reported Event|Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure.
1262920|NCT00005947|E1|Reported Event|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.
1262921|NCT00005937|B1|Baseline|MDS Subjects Treated With ATG and CsA|Myelodysplastic syndromes (MDS) subjects will be treated with Antithymocyte Globulin (ATG) and cyclosporine (CsA). The subjects will receive ATG at a dose of 40mg/kg orally on days 1-4 in combination with oral prednisone at a dose of 1mg/kg/day on day one. The prednisone will be tapered on day 10. The taper schedule will be every two days over a total of eight days (days 10-17). Drug the ATG administration, the subjects will receive at least 4 units of platelets daily for platelet counts less than 20,000/ microliters. Cyclosporine (CsA) will be started on day 14 at a dose of 5mg/kg twice daily with dose adjustments based on drug levels (target 200-400 ng/ml). Cyclosporine therapy will be continued for six months.
1262922|NCT00005937|P1|Participant Flow|MDS Subjects Treated With ATG & CsA|Myelodysplastic syndromes (MDS) subjects will be treated with Anti-thymocyte Globulin (ATG) and cyclosporine (CsA). The subjects will receive ATG at a dose of 40mg/kg orally on days 1-4 in combination with oral prednisone at a dose of 1mg/kg/day on day one. The prednisone will be tapered on day 10. The taper schedule will be every two days over a total of eight days (days 10-17). Drug the ATG administration the subjects will receive at least 4 units of platelets daily for platelet counts less than 20,000/ microliters. Cyclosporine (CsA) will be started on day 14 at a dose of 5mg/kg twice daily with dose adjustments based on drug levels (target 200-400 ng/ml). Cyclosporine therapy will be continued for six months.
1262923|NCT00005937|O1|Outcome|MDS Subjects Treated With ATG and CsA|Myelodysplastic syndromes (MDS) subjects will be treated with Anti-thymocyte Globulin (ATG) and cyclosporine (CsA). The subjects will receive ATG at a dose of 40mg/kg orally on days 1-4 in combination with oral prednisone at a dose of 1mg/kg/day on day one. The prednisone will be tapered on day 10. The taper schedule will be every two days over a total of eight days (days 10-17). Drug the ATG administration the subjects will receive at least 4 units of platelets daily for platelet counts less than 20,000/ microliters. Cyclosporine (CsA) will be started on day 14 at a dose of 5mg/kg twice daily with dose adjustments based on drug levels (target 200-400 ng/ml). Cyclosporine therapy will be continued for six months.
1262966|NCT00005879|O1|Outcome|Placebo|"Placebo~Placebo: matched tablet dialy"
1262924|NCT00005937|E1|Reported Event|MDS Subjects Treated With ATG and CsA|Myelodysplastic syndromes (MDS) subjects will be treated with Anti-thymocyte Globulin (ATG) and cyclosporine (CsA). The subjects will receive ATG at a dose of 40mg/kg orally on days 1-4 in combination with oral prednisone at a dose of 1mg/kg/day on day one. The prednisone will be tapered on day 10. The taper schedule will be every two days over a total of eight days (days 10-17). Drug the ATG administration the subjects will receive at least 4 units of platelets daily for platelet counts less than 20,000/ microliters. Cyclosporine (CsA) will be started on day 14 at a dose of 5mg/kg twice daily with dose adjustments based on drug levels (target 200-400 ng/ml). Cyclosporine therapy will be continued for six months.
1262925|NCT00005908|B1|Baseline|Docetaxel/Capecitabine - A & B|Docetaxel/Capecitabine - A- Docetaxel 75 mg/m^2 intravenous day 1,capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles. Docetaxel/Capecitabine - B- Docetaxel 60 mg/m^2 intravenous day 1 capecitabine 937.5 mg/m^2 orally twice daily day 2-15
1262926|NCT00005908|P2|Participant Flow|Dose B-Cohort 2-Arm 2 Reduced Dose-Docetaxel & Capecitabine|Docetaxel 60 mg/m^2 intravenous day 1 capecitabine 937.5 mg/m^2 orally twice daily day 2-15
1262927|NCT00005908|P1|Participant Flow|Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine|Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles Once the dose was deemed to be too toxic, subsequent patients were enrolled on dose B.
1262928|NCT00005908|O1|Outcome|Dose A & B-Cohort 1 & 2-Arm 1 & 2-Docetaxel & Capecitabine|Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles
1262929|NCT00005908|O2|Outcome|Dose B-Cohort 2-Arm 2 Reduced Dose-Docetaxel & Capecitabine|Docetaxel 60 mg/m^2 intravenous day 1, capecitabine 937.5 mg/m^2 orally twice daily day 2-15
1262930|NCT00005908|O1|Outcome|Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine|Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles
1262931|NCT00005908|O1|Outcome|Dose A & B-Cohort 1 & 2-Arm 1& 2-Docetaxel & Capecitabine|Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles Docetaxel 60 mg/m^2 intravenous day 1 capecitabine 937.5 mg/m^2 orally twice daily day 2-15
1262932|NCT00005908|O2|Outcome|Dose B-Cohort 2-Arm 2 Reduced Dose-Docetaxel & Capecitabine|Docetaxel 60 mg/m^2 intravenous day 1 capecitabine 937.5 mg/m^2 orally twice daily day 2-15
1262933|NCT00005908|O1|Outcome|Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine|Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles Once the dose was deemed to be too toxic, subsequent patients were enrolled on dose B.
1262934|NCT00005908|E1|Reported Event|Docetaxel/Capecitabine - A & B|Docetaxel/Capecitabine - A- Docetaxel 75 mg/m^2 intravenous day 1,capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles. Docetaxel/Capecitabine - B- Docetaxel 60 mg/m2 intravenous day 1 capecitabine 937.5 mg/m2 orally twice daily day 2-15
1262935|NCT00005906|B1|Baseline|Octreotide|Patients with lymphangioleiomyomatosis and lymphatic tumors causing chylous effusions and abdominal pain
1262936|NCT00005906|P1|Participant Flow|Octreotide|Patients with lymphangioleiomyomatosis and lymphatic tumors causing chylous effusions and abdominal pain
1262937|NCT00005906|O1|Outcome|Octreotide|Patients with lymphangioleiomyomatosis and lymphatic tumors causing chylous effusions and abdominal pain
1262938|NCT00005906|O1|Outcome|Octreotide|Patients with lymphangioleiomyomatosis and lymphatic tumors causing chylous effusions and abdominal pain
1262939|NCT00005906|O1|Outcome|Octreotide|Patients with lymphangioleiomyomatosis and lymphatic tumors causing chylous effusions and abdominal pain
1262940|NCT00005906|E1|Reported Event|Octreotide|Patients with lymphangioleiomyomatosis and lymphatic tumors causing chylous effusions and abdominal pain
1262941|NCT00005901|B3|Baseline|Total|Total of all reporting groups
1262942|NCT00005901|B2|Baseline|Active Comparator: 2|Subjects who received Pamidronate every 6 months for 3 years.
1262943|NCT00005901|B1|Baseline|Active Comparator: 1|Subjects who received Pamidronate every 3 months for 3 years.
1262944|NCT00005901|P2|Participant Flow|Active Comparator: 2|Receives treatment every 6 months.
1262945|NCT00005901|P1|Participant Flow|Active Comparator: 1|Receives treatment every 3 months
1262946|NCT00005901|O2|Outcome|Pamidronate Every 6 Months for 3 Years|Subjects who received Pamidronate every 6 months for 3 years.
1262947|NCT00005901|O1|Outcome|Pamidronate Every 3 Months for 3 Years|Subjects who received Pamidronate every 3 months for 3 years.
1262948|NCT00005901|O2|Outcome|Pamidronate Every 6 Months for 3 Years|Subjects who received Pamidronate every 6 months for 3 years.
1262949|NCT00005901|O1|Outcome|Pamidronate Every 3 Months for 3 Years|Subjects who received Pamidronate every 3 months for 3 years.
1262950|NCT00005901|O2|Outcome|Pamidronate Every 6 Months for 3 Years|Subjects who received Pamidronate every 6 months for 3 years.
1262951|NCT00005901|O1|Outcome|Pamidronate Every 3 Months for 3 Years|Subjects who received Pamidronate every 3 months for 3 years.
1262952|NCT00005901|O2|Outcome|Pamidronate Every 6 Months for 3 Years|Subjects who received Pamidronate every 6 months for 3 years.
1262953|NCT00005901|O1|Outcome|Pamidronate Every 3 Months for 3 Years|Subjects who received Pamidronate every 3 months for 3 years.
1262954|NCT00005901|O2|Outcome|Pamidronate Every 6 Months for 3 Years|Subjects who received Pamidronate every 6 months for 3 years.
1262955|NCT00005901|O1|Outcome|Pamidronate Every 3 Months for 3 Years|Subjects who received Pamidronate every 3 months for 3 years.
1262956|NCT00005901|O2|Outcome|Pamidronate Every 6 Months for 3 Years|Subjects who received Pamidronate every 6 months for 3 years.
1262957|NCT00005901|O1|Outcome|Pamidronate Every 3 Months for 3 Years|Subjects who received Pamidronate every 3 months for 3 years.
1262958|NCT00005901|E2|Reported Event|Active Comparator: 2|Subjects who received Pamidronate every 6 months for 3 years.
1262959|NCT00005901|E1|Reported Event|Active Comparator: 1|Subjects who received Pamidronate every 3 months for 3 years.
1262960|NCT00005879|B3|Baseline|Total|Total of all reporting groups
1262961|NCT00005879|B2|Baseline|Arzoxifene|"LY353381, 20 mg daily~arzoxifene: one tablet daily"
1262962|NCT00005879|B1|Baseline|Placebo|"Placebo~Placebo: matched tablet dialy"
1262963|NCT00005879|P2|Participant Flow|Arzoxifene|"LY353381, 20 mg daily~arzoxifene: one tablet daily"
1262964|NCT00005879|P1|Participant Flow|Placebo|"Placebo~Placebo: matched tablet dialy"
1262965|NCT00005879|O2|Outcome|Arzoxifene|"LY353381, 20 mg daily~arzoxifene: one tablet daily"
1262969|NCT00005879|E2|Reported Event|Arzoxifene|"LY353381, 20 mg daily~arzoxifene: one tablet daily"
1262970|NCT00005879|E1|Reported Event|Placebo|"Placebo~Placebo: matched tablet dialy"
1262971|NCT00005669|B3|Baseline|Total|Total of all reporting groups
1262972|NCT00005669|B2|Baseline|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
1262973|NCT00005669|B1|Baseline|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
1262974|NCT00005669|P2|Participant Flow|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
1262975|NCT00005669|P1|Participant Flow|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
1262976|NCT00005669|O2|Outcome|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
1262977|NCT00005669|O1|Outcome|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
1262978|NCT00005669|O2|Outcome|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
1262979|NCT00005669|O1|Outcome|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
1262980|NCT00005669|O2|Outcome|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
1262981|NCT00005669|O1|Outcome|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
1262982|NCT00005669|O2|Outcome|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
1262983|NCT00005669|O1|Outcome|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
1262984|NCT00005669|O2|Outcome|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
1262985|NCT00005669|O1|Outcome|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
1262986|NCT00005669|E2|Reported Event|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
1262987|NCT00005669|E1|Reported Event|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
1262988|NCT00005047|B5|Baseline|Total|Total of all reporting groups
1262989|NCT00005047|B4|Baseline|Arm IV: Observation|p53 positive, refused random assignment, assigned to observation/no intervention
1262990|NCT00005047|B3|Baseline|Arm III: Observation|p53 negative, assigned to observation/no intervention
1262991|NCT00005047|B2|Baseline|Arm II: Observation|p53 positive, randomized to observation/no intervention
1262992|NCT00005047|B1|Baseline|Arm I: M-VAC x 3|p53 positive, randomized to 3 cycles of adjuvant combination methotrexate, vinblastine, doxorubicin and cisplatin (MVAC)
1262993|NCT00005047|P4|Participant Flow|Arm IV: Observation|Patients with altered (+) p53, patients did not consent to randomization
1262994|NCT00005047|P3|Participant Flow|Arm III: Observation|Patients with unaltered (-) p53
1262995|NCT00005047|P2|Participant Flow|Arm II: Observation|Patients with altered (+) p53, reconsented to randomization, randomized to observation
1262996|NCT00005047|P1|Participant Flow|Arm I: M-VAC x 3|"Patients with altered (+) p53, reconsented to randomization, randomized to three cycles of MVAC~cisplatin~doxorubicin hydrochloride~methotrexate~vinblastine"
1262997|NCT00005047|O2|Outcome|p53 Negative Patients|Arm III: Observation; Patients with unaltered (-) p53
1262998|NCT00005047|O1|Outcome|p53 Positive Patients|"Arm I: Patients with altered (+) p53, reconsented to randomization, randomized to three cycles of MVAC~Arm II: Patients with altered (+) p53, reconsented to randomization, randomized to observation~Arm IV: Patients with altered (+) p53, patients did not consent to randomization"
1262999|NCT00005047|O2|Outcome|p53 Negative Patients|Arm III: Observation; Patients with unaltered (-) p53
1263000|NCT00005047|O1|Outcome|p53 Positive Patients|"Arm I: Patients with altered (+) p53, reconsented to randomization, randomized to three cycles of MVAC~Arm II: Patients with altered (+) p53, reconsented to randomization, randomized to observation~Arm IV: Patients with altered (+) p53, patients did not consent to randomization"
1263001|NCT00005047|O2|Outcome|Arm II: Observation|Patients with altered (+) p53, reconsented to randomization, randomized to observation
1263002|NCT00005047|O1|Outcome|Arm I: M-VAC x 3|"Patients with altered (+) p53, reconsented to randomization, randomized to three cycles of MVAC~cisplatin~doxorubicin hydrochloride~methotrexate~vinblastine"
1263076|NCT00004859|O1|Outcome|Arm A (Paclitaxel + Carboplatin + Radiation )|active comparator
1263003|NCT00005047|O2|Outcome|Arm II: Observation|Patients with altered (+) p53, reconsented to randomization, randomized to observation
1263004|NCT00005047|O1|Outcome|Arm I: M-VAC x 3|"Patients with altered (+) p53, reconsented to randomization, randomized to three cycles of MVAC~cisplatin~doxorubicin hydrochloride~methotrexate~vinblastine"
1263005|NCT00005047|E4|Reported Event|Arm IV: Observation|Patients with altered (+) p53, patients did not consent to randomization
1263006|NCT00005047|E3|Reported Event|Arm III: Observation|Patients with unaltered (-) p53
1263007|NCT00005047|E2|Reported Event|Arm II: Observation|Patients with altered (+) p53, reconsented to randomization, randomized to observation
1263008|NCT00005047|E1|Reported Event|Arm I: M-VAC x 3|"Patients with altered (+) p53, reconsented to randomization, randomized to three cycles of MVAC~cisplatin~doxorubicin hydrochloride~methotrexate~vinblastine"
1263009|NCT00004980|B3|Baseline|Total|Total of all reporting groups
1263010|NCT00004980|B2|Baseline|Placebo|Participants received sham stimulation
1263011|NCT00004980|B1|Baseline|Active Repetitive Transcanial Magnetic Stimulation|Participants received active repetitive transcranial magnetic stimulation (rTMS)
1263012|NCT00004980|P2|Participant Flow|Placebo|Participants received sham stimulation
1263013|NCT00004980|P1|Participant Flow|Active Repetitive Transcanial Magnetic Stimulation|Participants received active repetitive transcranial magnetic stimulation (rTMS)
1263014|NCT00004980|O2|Outcome|Placebo|Participants received sham stimulation
1263015|NCT00004980|O1|Outcome|Active Repetitive Transcanial Magnetic Stimulation|Participants received active repetitive transcranial magnetic stimulation (rTMS)
1263016|NCT00004980|O2|Outcome|Placebo|Participants received sham stimulation
1263017|NCT00004980|O1|Outcome|Active Repetitive Transcanial Magnetic Stimulation|Participants received active repetitive transcranial magnetic stimulation (rTMS)
1263018|NCT00004980|O2|Outcome|Placebo|Participants received sham stimulation
1263019|NCT00004980|O1|Outcome|Active Repetitive Transcanial Magnetic Stimulation|Participants received active repetitive transcranial magnetic stimulation (rTMS)
1263020|NCT00004980|O2|Outcome|Placebo|Participants received sham stimulation
1263021|NCT00004980|O1|Outcome|Active Repetitive Transcanial Magnetic Stimulation|Participants received active repetitive transcranial magnetic stimulation (rTMS)
1263022|NCT00004980|E2|Reported Event|Placebo|Participants received sham stimulation
1263023|NCT00004980|E1|Reported Event|Active Repetitive Transcanial Magnetic Stimulation|Participants received active repetitive transcranial magnetic stimulation (rTMS)
1263024|NCT00004978|B3|Baseline|Total|Total of all reporting groups
1263025|NCT00004978|B2|Baseline|No rIL-2|Control group - no study-assigned medication
1263026|NCT00004978|B1|Baseline|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
1263027|NCT00004978|P2|Participant Flow|No rIL-2|Control group - no study-assigned medication
1263028|NCT00004978|P1|Participant Flow|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
1263029|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
1263030|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
1263031|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
1263032|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
1263033|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
1263034|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
1263035|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
1263036|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
1263037|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
1263038|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
1263039|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
1263040|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
1263041|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
1263042|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
1263043|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
1263044|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
1263045|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
1263046|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
1263047|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
1263048|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
1263049|NCT00004978|E2|Reported Event|No rIL-2|Control group - no study-assigned medication
1263050|NCT00004978|E1|Reported Event|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
1263051|NCT00004888|B3|Baseline|Total|Total of all reporting groups
1263052|NCT00004888|B2|Baseline|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
1263053|NCT00004888|B1|Baseline|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
1263054|NCT00004888|P2|Participant Flow|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
1263074|NCT00004859|P1|Participant Flow|Arm A (Paclitaxel + Carboplatin + Radiation )|Active comparator. Induction dosing: Paclitaxel, 225 mg/m²; Carboplatin, AUC=6.0. Concurrent dosing: Paclitaxel, 45 mg/m2; Carboplatin: AUC=2.
1263112|NCT00004563|O2|Outcome|Placebo|"Matching gel caps at a dose of 25 mg~Placebo: Matching gelcaps 25 mgs"
1263055|NCT00004888|P1|Participant Flow|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
1263056|NCT00004888|O2|Outcome|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
1263057|NCT00004888|O1|Outcome|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
1263058|NCT00004888|O2|Outcome|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
1263059|NCT00004888|O1|Outcome|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
1263060|NCT00004888|O2|Outcome|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
1263061|NCT00004888|O1|Outcome|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
1263062|NCT00004888|O2|Outcome|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
1263063|NCT00004888|O1|Outcome|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
1263064|NCT00004888|O2|Outcome|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
1263065|NCT00004888|O1|Outcome|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
1263066|NCT00004888|O2|Outcome|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
1263067|NCT00004888|O1|Outcome|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
1263068|NCT00004888|E2|Reported Event|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
1263069|NCT00004888|E1|Reported Event|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
1263070|NCT00004859|B3|Baseline|Total|Total of all reporting groups
1263071|NCT00004859|B2|Baseline|Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)|"Experimental arm. Thalidomide: daily, patients begin with 200 mg thalidomide PO as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg; low dose aspirin: 81mg PO daily.~Paclitaxel, carboplatin and radiation same as active comparator."
1263072|NCT00004859|B1|Baseline|Arm A (Paclitaxel + Carboplatin + Radiation )|Active comparator. Induction dosing: Paclitaxel, 225 mg/m²; Carboplatin, AUC=6.0. Concurrent dosing: Paclitaxel, 45 mg/m2; Carboplatin: AUC=2.
1263073|NCT00004859|P2|Participant Flow|Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)|"Experimental arm. Thalidomide: daily, patients begin with 200 mg thalidomide PO as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg; low dose aspirin: 81mg PO daily.~Paclitaxel, carboplatin and radiation same as active comparator."
1263075|NCT00004859|O2|Outcome|Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)|experimental arm
1263077|NCT00004859|O2|Outcome|Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)|"Experimental arm. Thalidomide: daily, patients begin with 200 mg thalidomide PO as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg; low dose aspirin: 81mg PO daily.~Paclitaxel, carboplatin and radiation same as active comparator."
1263078|NCT00004859|O1|Outcome|Arm A (Paclitaxel + Carboplatin + Radiation )|Active comparator. Induction dosing: Paclitaxel, 225 mg/m²; Carboplatin, AUC=6.0. Concurrent dosing: Paclitaxel, 45 mg/m2; Carboplatin: AUC=2.
1263079|NCT00004859|O2|Outcome|Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)|experimental arm
1263080|NCT00004859|O1|Outcome|Arm A (Paclitaxel + Carboplatin + Radiation )|active comparator
1263081|NCT00004859|E2|Reported Event|Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)|"Experimental arm. Thalidomide: daily, patients begin with 200 mg thalidomide PO as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg; low dose aspirin: 81mg PO daily.~Paclitaxel, carboplatin and radiation same as active comparator."
1263082|NCT00004859|E1|Reported Event|Arm A (Paclitaxel + Carboplatin + Radiation )|Active comparator. Induction dosing: Paclitaxel, 225 mg/m²; Carboplatin, AUC=6.0. Concurrent dosing: Paclitaxel, 45 mg/m2; Carboplatin: AUC=2.
1263083|NCT00004732|B3|Baseline|Total|Total of all reporting groups
1263084|NCT00004732|B2|Baseline|Carotid Endarterectomy|Patients Randomized to CEA
1263085|NCT00004732|B1|Baseline|Carotid-Artery Stenting|Patients Randomized to CAS
1263086|NCT00004732|P2|Participant Flow|Carotid Endarterectomy (CEA)|CEA involves a neck incision and physical removal of the plaque from the inside of the carotid artery.
1263087|NCT00004732|P1|Participant Flow|Carotid-Artery Stenting (CAS)|CAS involves insertion of a catheter or tube into an artery in the groin and then threading the catheter through the arteries of the body to the location of the plaque within the carotid artery in the neck. The stent is then placed to cover the plaque and hold the artery open.
1263088|NCT00004732|O2|Outcome|Carotid Endarterectomy|Patients randomized to CEA
1263089|NCT00004732|O1|Outcome|Carotid-Artery Stenting|Patients randomized to CAS
1263090|NCT00004732|O2|Outcome|Carotid Endarterectomy|Patients Randomized to CEA
1263091|NCT00004732|O1|Outcome|Carotid-Artery Stenting|Patients Randomized to CAS
1263092|NCT00004732|E2|Reported Event|Carotid Endarterectomy|Patients Randomized to CEA
1263093|NCT00004732|E1|Reported Event|Carotid-Artery Stenting|Patients Randomized to CAS
1263094|NCT00004635|B3|Baseline|Total|Total of all reporting groups
1263095|NCT00004635|B2|Baseline|Placebo Followed by Thalidomide|Study participants are randomly assigned to one of two treatment groups. Participants received leuprolide or goserelin for 6 months. In period 1 participants received placebo for thalidomide. Patients will be followed until PSA progression defined as prostate-specific antigen (PSA) level that returns to what it was before beginning leuprolide or goserelin or to 5 nanograms per liter, whichever is lower. The participants are returned to the leuprolide or goserelin treatment for 6 months. In period 2 participants received thalidomide 200 mg once a day.
1263096|NCT00004635|B1|Baseline|Thalidomide Followed by Placebo|Study participants are randomly assigned to one of two treatment groups. Participants received leuprolide or goserelin for 6 months. In period 1 participants received thalidomide orally 200 mg a day. Patients will be followed until PSA progression defined as prostate-specific antigen (PSA) level that returns to what it was before beginning leuprolide or goserelin or to 5 nanograms per liter, whichever is lower. The participants are returned to the leuprolide or goserelin treatment for 6 months. In period 2 participants received the placebo for thalidomide once a day.
1263097|NCT00004635|P2|Participant Flow|Placebo Followed by Thalidomide|Study participants are randomly assigned to one of two treatment groups. Participants received leuprolide or goserelin for 6 months. In period 1 participants received placebo for thalidomide. Patients will be followed until PSA progression defined as prostate-specific antigen (PSA) level that returns to what it was before beginning leuprolide or goserelin or to 5 nanograms per liter, whichever is lower. The participants are returned to the leuprolide or goserelin treatment for 6 months. In period 2 participants received thalidomide 200 mg once a day.
1263098|NCT00004635|P1|Participant Flow|Thalidomide Followed by Placebo|Study participants are randomly assigned to one of two treatment groups. Participants received leuprolide or goserelin for 6 months. In period 1 participants received thalidomide orally 200 mg a day. Patients will be followed until PSA progression defined as prostate-specific antigen (PSA) level that returns to what it was before beginning leuprolide or goserelin or to 5 nanograms per liter, whichever is lower. The participants are returned to the leuprolide or goserelin treatment for 6 months. In period 2 participants received the placebo for thalidomide once a day.
1263099|NCT00004635|O2|Outcome|Placebo|Participants who received placebo in period 1 or 2.
1263100|NCT00004635|O1|Outcome|Thalidomide|Participants who received thalidomide in period 1 or 2.
1263101|NCT00004635|O2|Outcome|Placebo|Participants who received placebo in period 1 or 2
1263102|NCT00004635|O1|Outcome|Thalidomide|Participants who received thalidomide in period 1 or 2.
1263103|NCT00004635|E4|Reported Event|Leuprolide|
1263104|NCT00004635|E3|Reported Event|Goserelin (Zoladex)|
1263105|NCT00004635|E2|Reported Event|Placebo|
1263106|NCT00004635|E1|Reported Event|Thalidomide|
1263107|NCT00004563|B3|Baseline|Total|Total of all reporting groups
1263108|NCT00004563|B2|Baseline|Placebo|"Matching gel caps at a dose of 25 mg~Placebo: Matching gelcaps 25 mgs"
1263109|NCT00004563|B1|Baseline|Cylophosphamide|"Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.~Cyclophosphamide: Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram."
1263110|NCT00004563|P2|Participant Flow|Placebo|"Matching gel caps at a dose of 25 mg~Placebo: Matching gelcaps 25 mgs"
1263111|NCT00004563|P1|Participant Flow|Cylophosphamide|"Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.~Cyclophosphamide: Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram."
1263113|NCT00004563|O1|Outcome|Cylophosphamide|"Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.~Cyclophosphamide: Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram."
1263114|NCT00004563|O2|Outcome|Placebo|"Matching gel caps at a dose of 25 mg~Placebo: Matching gelcaps 25 mgs"
1263115|NCT00004563|O1|Outcome|Cylophosphamide|"Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.~Cyclophosphamide: Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram."
1263116|NCT00004563|O2|Outcome|Placebo|"Matching gel caps at a dose of 25 mg~Placebo: Matching gelcaps 25 mgs"
1263117|NCT00004563|O1|Outcome|Cylophosphamide|"Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.~Cyclophosphamide: Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram."
1263118|NCT00004563|E2|Reported Event|Placebo|"Matching gel caps at a dose of 25 mg~Placebo: Matching gelcaps 25 mgs"
1263119|NCT00004563|E1|Reported Event|Cylophosphamide|"Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.~Cyclophosphamide: Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram."
1263120|NCT00004562|B3|Baseline|Total|Total of all reporting groups
1263121|NCT00004562|B2|Baseline|Medical Therapy Group|Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
1263122|NCT00004562|B1|Baseline|Percutaneous Coronary Intervention Group|Percutaneous Coronary Intervention with stent placement and optimal medical therapy
1263123|NCT00004562|P2|Participant Flow|Medical Therapy Group|Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
1263124|NCT00004562|P1|Participant Flow|Percutaneous Coronary Intervention Group|Percutaneous Coronary Intervention with stent placement and optimal medical therapy
1263125|NCT00004562|O2|Outcome|Medical Therapy Group|Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
1263126|NCT00004562|O1|Outcome|Percutaneous Coronary Intervention Group|Percutaneous Coronary Intervention with stent placement and optimal medical therapy
1263127|NCT00004562|O2|Outcome|Medical Therapy Group|Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
1263128|NCT00004562|O1|Outcome|Percutaneous Coronary Intervention Group|Percutaneous Coronary Intervention with stent placement and optimal medical therapy
1263129|NCT00004562|E2|Reported Event|Medical Therapy Group|Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
1263130|NCT00004562|E1|Reported Event|Percutaneous Coronary Intervention Group|Percutaneous Coronary Intervention with stent placement and optimal medical therapy
1263131|NCT00004547|B4|Baseline|Total|Total of all reporting groups
1263132|NCT00004547|B3|Baseline|Adenocarcinoma of Gastrointestinal Origin|Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
1263133|NCT00004547|B2|Baseline|Low Grade Mucinous Adenocarcinoma|Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
1263134|NCT00004547|B1|Baseline|Peritoneal Mesothelioma|Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
1263135|NCT00004547|P3|Participant Flow|Adenocarcinoma of Gastrointestinal Origin|Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
1263136|NCT00004547|P2|Participant Flow|Low Grade Mucinous Adenocarcinoma|Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
1263156|NCT00004500|B1|Baseline|Lucinactant|Lucinactant via bronchoaveolar lavage
1263137|NCT00004547|P1|Participant Flow|Peritoneal Mesothelioma|Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
1263138|NCT00004547|O2|Outcome|Tumor Tissue|Diseased tissue
1263139|NCT00004547|O1|Outcome|Normal Tissue|Non-diseased tissue
1263140|NCT00004547|O3|Outcome|Adenocarcinoma of Gastrointestinal Origin|Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
1263141|NCT00004547|O2|Outcome|Low Grade Mucinous Adenocarcinoma|Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
1263142|NCT00004547|O1|Outcome|Peritoneal Mesothelioma|Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
1263143|NCT00004547|O3|Outcome|Adenocarcinoma of Gastrointestinal Origin|Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
1263144|NCT00004547|O2|Outcome|Low Grade Mucinous Adenocarcinoma|Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
1263145|NCT00004547|O1|Outcome|Peritoneal Mesothelioma|Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
1263146|NCT00004547|O1|Outcome|Mesothelioma, Low Grade, and Adenocarcinoma|Patients with peritoneal mesothelioma suffer with intractable ascites. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer, tend to be more invasive.
1263147|NCT00004547|O3|Outcome|Adenocarcinoma of Gastrointestinal Origin|Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
1263148|NCT00004547|O2|Outcome|Low Grade Mucinous Adenocarcinoma|Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
1263149|NCT00004547|O1|Outcome|Peritoneal Mesothelioma|Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
1263150|NCT00004547|O3|Outcome|Adenocarcinoma of Gastrointestinal Origin|Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
1263151|NCT00004547|O2|Outcome|Low Grade Mucinous Adenocarcinoma|Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
1263152|NCT00004547|O1|Outcome|Peritoneal Mesothelioma|Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
1263153|NCT00004547|E1|Reported Event|Mesothelioma, Low Grade, and Adenocarcinoma|Patients with peritoneal mesothelioma suffer with intractable ascites. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer, tend to be more invasive.
1263154|NCT00004500|B3|Baseline|Total|Total of all reporting groups
1263155|NCT00004500|B2|Baseline|Standard Care|Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
1263157|NCT00004500|P2|Participant Flow|Standard Care|Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
1263158|NCT00004500|P1|Participant Flow|Lucinactant|Lucinactant via bronchoaveolar lavage
1263159|NCT00004500|O2|Outcome|Standard Care|Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
1263160|NCT00004500|O1|Outcome|Lucinactant|Lucinactant via bronchoaveolar lavage
1263161|NCT00004500|O2|Outcome|Standard Care|Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
1263162|NCT00004500|O1|Outcome|Lucinactant|Lucinactant via bronchoaveolar lavage
1263163|NCT00004500|O2|Outcome|Standard Care|Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
1263164|NCT00004500|O1|Outcome|Lucinactant|Lucinactant via bronchoaveolar lavage
1263165|NCT00004500|E2|Reported Event|Standard Care|Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
1263166|NCT00004500|E1|Reported Event|Lucinactant|Lucinactant via bronchoaveolar lavage
1263167|NCT00004412|B4|Baseline|Total|Total of all reporting groups
1263168|NCT00004412|B3|Baseline|Crossover|Patients are randomly assigned (following a table of random numbers prepared by a blinded statistician) between two arms of the study. Arm I is Standard local care dressing only, and Arm II is standard local care plus Arginine Butyrate (AB), the Investigational New Drug. Ulcers observed & traced weekly. Ulcer area calculated by computerized planimetry. After 12 weeks of therapy, if the ulcer size decreased by at least 25%, the AB may be continued for another 8 weeks (twice), or until the ulcer closes, plus an additional 2 weeks. The patients randomized to the Control Arm ( standard local care) were given the option of crossing over to Arm II If, ulcers did not close after 8 weeks of standard local care.
1263169|NCT00004412|B2|Baseline|Arginine Butyrate|Arginine Butyrate IV plus Standard local care dressing for a total of 12 weeks. Low dose 250 mg/kg or, increased dose 750 mg/kg. First week AB given 5 days in a row, over 8 to 12hours.
1263170|NCT00004412|B1|Baseline|Standard Local Care Dressing|Standard local care dressing including cleaning, saline irrigation, dressing changes only for 8 weeks twice a week.
1263171|NCT00004412|P3|Participant Flow|Crossover|Patients are randomly assigned (following a table of random numbers prepared by a blinded statistician) between two arms of the study. Arm I is Allevyn Hydrophilic PU dressing (standard local care) only, and Arm II is standard local care plus Arginine Butyrate (AB), the Investigational New Drug. Ulcers observed & traced weekly. Ulcer area calculated by computerized planimetry. After 12 weeks of therapy, if the ulcer size decreased by at least 25%, the AB may be continued for another 8 weeks (twice), or until the ulcer closes, plus an additional 2 weeks. The patients randomized to the Control Arm ( standard local care) were given the option of crossing over to Arm II If, ulcers did not close after 8 weeks of standard local care.
1263172|NCT00004412|P2|Participant Flow|Arginine Butyrate|Arginine Butyrate IV plus Standard local care dressing for a total of 12 weeks. Low dose 250 mg/kg or, increased dose 750 mg/kg. First week AB given 5 days in a row, over 8 to 12hours.
1263173|NCT00004412|P1|Participant Flow|Standard Local Care Dressing|Standard local care includng cleaning, saline irrigation, dressing changes only for 8 weeks twice a week.
1263174|NCT00004412|O2|Outcome|Arginine Butyrate|Arginine Butyrate IV plus Standard local care dressing for a total of 12 weeks. Low dose 250 mg/kg or, increased dose 750 mg/kg. First week AB given 5 days in a row, over 8 to 12hours.
1263175|NCT00004412|O1|Outcome|Standard Local Care Dressing|Standard local care includng cleaning, saline irrigation, dressing changes only for 8 weeks twice a week.
1263176|NCT00004412|O2|Outcome|Arginine Butyrate|Arginine Butyrate IV plus Standard local care dressing for a total of 12 weeks. Low dose 250 mg/kg or, increased dose 750 mg/kg. First week AB given 5 days in a row, over 8 to 12hours.
1263177|NCT00004412|O1|Outcome|Standard Local Care Dressing|Standard local care includng cleaning, saline irrigation, dressing changes only for 8 weeks twice a week.
1263178|NCT00004412|E2|Reported Event|Arginine Butyrate|Arginine Butyrate IV plus Standard local care dressing for a total of 12 weeks. Low dose 250 mg/kg or, increased dose 750 mg/kg. First week AB given 5 days in a row, over 8 to 12hours.
1263179|NCT00004412|E1|Reported Event|Standard Local Care Dressing|Standard local care including cleaning, saline irrigation, dressing changes only for 8 weeks twice a week.
1263180|NCT00004228|B8|Baseline|Total|Total of all reporting groups
1263181|NCT00004228|B7|Baseline|B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
1263182|NCT00004228|B6|Baseline|B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
1263235|NCT00004092|P2|Participant Flow|Arm II (STAMP V)|"Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I.~filgrastim: Given IV or subcutaneously~carboplatin: Given IV~cyclophosphamide: Given IV~thiotepa: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
1263256|NCT00003910|E2|Reported Event|Cyclophosphamide|step 2 patients who received CY
1263320|NCT00003869|O1|Outcome|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
1263183|NCT00004228|B5|Baseline|B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
1263184|NCT00004228|B4|Baseline|B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
1263185|NCT00004228|B3|Baseline|A2 (Disseminated, No CNS - CCG Mod BFM w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
1263186|NCT00004228|B2|Baseline|A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
1263187|NCT00004228|B1|Baseline|A0 (Localized Disease Stg I/II) Modified CCG BFM|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
1263188|NCT00004228|P7|Participant Flow|B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
1263189|NCT00004228|P6|Participant Flow|B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
1263190|NCT00004228|P5|Participant Flow|B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
1263191|NCT00004228|P4|Participant Flow|B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
1263236|NCT00004092|P1|Participant Flow|Arm I (ACT)|"Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover.~filgrastim: Given IV or subcutaneously~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
1263192|NCT00004228|P3|Participant Flow|A2 (Disseminated, No CNS - CCG Mod BFM w/ Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
1263193|NCT00004228|P2|Participant Flow|A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
1263194|NCT00004228|P1|Participant Flow|A0 (Localized Disease Stg I/II) Modified CCG BFM|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
1263195|NCT00004228|O7|Outcome|B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
1263196|NCT00004228|O6|Outcome|B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
1263197|NCT00004228|O5|Outcome|B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
1263198|NCT00004228|O4|Outcome|B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
1263199|NCT00004228|O3|Outcome|A2 (Disseminated, No CNS - CCG Mod BFM w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
1263200|NCT00004228|O2|Outcome|A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
1263201|NCT00004228|O1|Outcome|A0 (Localized Disease Stg I/II) Modified CCG BFM|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
1263202|NCT00004228|O7|Outcome|B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
1263203|NCT00004228|O6|Outcome|B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
1263204|NCT00004228|O5|Outcome|B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
1263205|NCT00004228|O4|Outcome|B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
1263206|NCT00004228|O3|Outcome|A2 (Disseminated, No CNS - CCG Mod BFM w/ Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
1263207|NCT00004228|O2|Outcome|A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
1263208|NCT00004228|O1|Outcome|A0 (Localized Disease Stg I/II) Modified CCG BFM|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
1263209|NCT00004228|E7|Reported Event|B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
1263210|NCT00004228|E6|Reported Event|B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
1263237|NCT00004092|O2|Outcome|Arm II (STAMP V)|"Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I.~filgrastim: Given IV or subcutaneously~carboplatin: Given IV~cyclophosphamide: Given IV~thiotepa: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
1263316|NCT00003869|O1|Outcome|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
1263317|NCT00003869|O2|Outcome|Placebo|250 mg placebo administered daily
1263211|NCT00004228|E5|Reported Event|B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
1263212|NCT00004228|E4|Reported Event|B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
1263213|NCT00004228|E3|Reported Event|A2 (Disseminated, No CNS - CCG Mod BFM w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate).
1263214|NCT00004228|E2|Reported Event|A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
1263215|NCT00004228|E1|Reported Event|A0 (Localized Disease Stg I/II) Modified CCG BFM|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
1263216|NCT00004146|B1|Baseline|CAI With RT - Arm 1|"CAI with RT~carboxyamidotriazole :~CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival~radiation therapy :"
1263217|NCT00004146|P1|Participant Flow|CAI With RT - Arm 1|"CAI with RT~carboxyamidotriazole :~CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival~radiation therapy :"
1263218|NCT00004146|O2|Outcome|CAI With RT Without Enzyme Inducing Anticonvulsants|"CAI with RT~carboxyamidotriazole :~CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival~radiation therapy :"
1263219|NCT00004146|O1|Outcome|CAI With RT + Enzyme Inducing Anticonvulsants|"CAI with RT~carboxyamidotriazole :~CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival~radiation therapy :"
1263220|NCT00004146|O1|Outcome|CAI With RT - Arm 1|"CAI with RT~carboxyamidotriazole :~CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival~radiation therapy :"
1263221|NCT00004146|O1|Outcome|CAI With RT - Arm 1|"CAI with RT~carboxyamidotriazole :~CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival~radiation therapy :"
1263222|NCT00004146|E1|Reported Event|Arm 1|"CAI with RT~carboxyamidotriazole :~CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival~radiation therapy :"
1263223|NCT00004143|B1|Baseline|All Patients|
1263224|NCT00004143|P1|Participant Flow|All Patients|
1263225|NCT00004143|O1|Outcome|All Patients|
1263226|NCT00004143|O1|Outcome|All Patients|
1263227|NCT00004143|O1|Outcome|All Patients|
1263228|NCT00004143|O1|Outcome|All Patients|
1263229|NCT00004143|O1|Outcome|All Patients|
1263230|NCT00004143|O1|Outcome|All Patients|
1263231|NCT00004143|E1|Reported Event|All Patients|
1263232|NCT00004092|B3|Baseline|Total|Total of all reporting groups
1263233|NCT00004092|B2|Baseline|Arm II (STAMP V)|"Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I.~filgrastim: Given IV or subcutaneously~carboplatin: Given IV~cyclophosphamide: Given IV~thiotepa: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
1263234|NCT00004092|B1|Baseline|Arm I (ACT)|"Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover.~filgrastim: Given IV or subcutaneously~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
1263238|NCT00004092|O1|Outcome|Arm I (ACT)|"Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover.~filgrastim: Given IV or subcutaneously~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
1263239|NCT00004092|O2|Outcome|Arm II (STAMP V)|"Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I.~filgrastim: Given IV or subcutaneously~carboplatin: Given IV~cyclophosphamide: Given IV~thiotepa: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
1263240|NCT00004092|O1|Outcome|Arm I (ACT)|"Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover.~filgrastim: Given IV or subcutaneously~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
1263241|NCT00004092|E2|Reported Event|Arm II (STAMP V)|"Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I.~filgrastim: Given IV or subcutaneously~carboplatin: Given IV~cyclophosphamide: Given IV~thiotepa: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
1263242|NCT00004092|E1|Reported Event|Arm I (ACT)|"Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover.~filgrastim: Given IV or subcutaneously~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
1263243|NCT00004054|B3|Baseline|Total|Total of all reporting groups
1263244|NCT00004054|B2|Baseline|Hormones and RT Plus Chemotherapy|AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) and estramustine phosphate sodium, etoposide, paclitaxel, and warfarin [Coumadin®]. AS will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.
1263245|NCT00004054|B1|Baseline|Hormones and RT|Androgen suppression (AS) (Luteinizing hormone releasing hormone [LHRH] agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]). AS will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of radiation therapy (RT).
1263246|NCT00004054|P2|Participant Flow|Hormones and RT Plus Chemotherapy|AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) and estramustine phosphate sodium, etoposide, paclitaxel, and warfarin [Coumadin®]. AS will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.
1263247|NCT00004054|P1|Participant Flow|Hormones and RT|Androgen suppression (AS) (Luteinizing hormone releasing hormone [LHRH] agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]). AS will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of radiation therapy (RT).
1263248|NCT00004054|O2|Outcome|Hormones and RT Plus Chemotherapy|AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) and estramustine phosphate sodium, etoposide, paclitaxel, and warfarin [Coumadin®]. AS will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.
1263249|NCT00004054|O1|Outcome|Hormones and RT|Androgen suppression (AS) (Luteinizing hormone releasing hormone [LHRH] agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]). AS will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of radiation therapy (RT).
1263250|NCT00004054|E2|Reported Event|Hormones and RT Plus Chemotherapy|AS (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and Casodex or Eulexin) and chemotherapy. Androgen suppression will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.
1263251|NCT00004054|E1|Reported Event|Hormones and RT|AS (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and Casodex or Eulexin). Androgen suppression will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of RT.
1263252|NCT00003910|B1|Baseline|Methotrexate|MTX given orally at 10 mg/m2 in divided doses once weekly. Prednisone was given orally at 1 mg/kg per day for 30 days and then tapered off in the subsequent 24 days. Patients not responding to MTX after 4 months received Cy orally at 100 mg daily in step two with the same prednisone schedule.
1263253|NCT00003910|P2|Participant Flow|Cyclophosphomide|Patients not responding to MTX after 4 months received Cy orally at 100 mg daily in step two with the same prednisone schedule.
1263254|NCT00003910|P1|Participant Flow|Methotrexate|"MTX given orally at 10 mg/m2 in divided doses once weekly. Prednisone was given orally at 1 mg/kg per day for 30 days and then tapered off in the subsequent 24 days. If patient had a partial response, MTX was continued for up to 1 year. If patient had CR, MTX was continued for 1 month.~If no response, then pt went onto step 2 and received CY."
1263255|NCT00003910|O1|Outcome|Methotrexate|MTX given orally at 10 mg/m2 in divided doses once weekly. Prednisone was given orally at 1 mg/kg per day for 30 days and then tapered off in the subsequent 24 days. Patients not responding to MTX after 4 months received Cy orally at 100 mg daily in step two with the same prednisone schedule.
1263257|NCT00003910|E1|Reported Event|Methotrexate|MTX given orally at 10 mg/m2 in divided doses once weekly. Prednisone was given orally at 1 mg/kg per day for 30 days and then tapered off in the subsequent 24 days. Patients not responding to MTX after 4 months received Cy orally at 100 mg daily in step two with the same prednisone schedule.
1263258|NCT00003907|B3|Baseline|Total|Total of all reporting groups
1263259|NCT00003907|B2|Baseline|Neuroendocrine Hepatic Metastases|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
1263260|NCT00003907|B1|Baseline|Hepatocellular Carcinoma|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
1263261|NCT00003907|P2|Participant Flow|Neuroendocrine Hepatic Metastases|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
1263262|NCT00003907|P1|Participant Flow|Hepatocellular Carcinoma|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
1263263|NCT00003907|O2|Outcome|Neuroendocrine Hepatic Metastases|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
1263264|NCT00003907|O1|Outcome|Hepatocellular Carcinoma|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
1263265|NCT00003907|O2|Outcome|Neuroendocrine Hepatic Metastases|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
1263266|NCT00003907|O1|Outcome|Hepatocellular Carcinoma|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
1263267|NCT00003907|O2|Outcome|Neuroendocrine Hepatic Metastases|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
1263268|NCT00003907|O1|Outcome|Hepatocellular Carcinoma|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
1263269|NCT00003907|E2|Reported Event|Neuroendocrine Hepatic Metastases|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
1263270|NCT00003907|E1|Reported Event|Hepatocellular Carcinoma|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
1263271|NCT00003901|B1|Baseline|Surgery|All patients undergo complete lymph node sampling or dissection. Patients are followed at 1, 4, 8, and 12 months, every 6 months for 2 years, and then annually for 2 years.
1263272|NCT00003901|P1|Participant Flow|Surgery|All patients undergo complete lymph node sampling or dissection. Patients are followed at 1, 4, 8, and 12 months, every 6 months for 2 years, and then annually for 2 years.
1263273|NCT00003901|O2|Outcome|OM Positive in Bone Marrow|Participants who had OM in bone marrow.
1263274|NCT00003901|O1|Outcome|OM Negative in Bone Marrow|Participants who did not have OM in bone marrow.
1263275|NCT00003901|O2|Outcome|OM Positive in Lymph Nodes|Participants who had OM in lymph nodes.
1263276|NCT00003901|O1|Outcome|OM Negative in Lymph Nodes|Participants who did not have OM in lymph nodes.
1263277|NCT00003901|O2|Outcome|OM Positive in Bone Marrow|Participants who had OM in bone marrow.
1263278|NCT00003901|O1|Outcome|OM Negative in Bone Marrow|Participants who did not have OM in bone marrow.
1263279|NCT00003901|O2|Outcome|OM Positive in Lymph Nodes|Participants who had OM in lymph nodes.
1263280|NCT00003901|O1|Outcome|OM Negative in Lymph Nodes|Participants who did not have OM in lymph nodes.
1263281|NCT00003901|E1|Reported Event|Surgery|All patients undergo complete lymph node sampling or dissection. Patients are followed at 1, 4, 8, and 12 months, every 6 months for 2 years, and then annually for 2 years.
1263282|NCT00003896|B1|Baseline|Paclitaxel/CDDP/Lipo Doxorubicin|intravenous paclitaxel (day 1), intraperitoneal cisplatin (day 2), intraperitoneal paclitaxel and intravenous liposomal doxorubicin (day 8)
1263283|NCT00003896|P1|Participant Flow|Paclitaxel/CDDP/Lipo Doxorubicin|intravenous paclitaxel (day 1), intraperitoneal cisplatin (day 2), intraperitoneal paclitaxel and intravenous liposomal doxorubicin (day 8)
1263284|NCT00003896|O1|Outcome|Paclitaxel/CDDP/Liposomal Doxorubicin|
1263285|NCT00003896|O1|Outcome|Paclitaxel/CDDP/Lipo Doxorubicin|intravenous paclitaxel (day 1), intraperitoneal cisplatin (day 2), intraperitoneal paclitaxel and intravenous liposomal doxorubicin (day 8)
1263286|NCT00003896|O1|Outcome|Paclitaxel/CDDP/Lipo Doxorubicin|intravenous paclitaxel (day 1), intraperitoneal cisplatin (day 2), intraperitoneal paclitaxel and intravenous liposomal doxorubicin (day 8)
1263287|NCT00003896|E1|Reported Event|Paclitaxel/CDDP/Liposomal Doxorubicin|
1263288|NCT00003895|B3|Baseline|Total|Total of all reporting groups
1263289|NCT00003895|B2|Baseline|Arm B (Every 3 Weeks)|
1263290|NCT00003895|B1|Baseline|Arm A (Every 2 Weeks)|
1263291|NCT00003895|P2|Participant Flow|gp100:209-217(210M) and HPV 16 E7:12-20 (Every 3 Weeks)|"Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 3 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.~HPV 16 E7:12-20 peptide vaccine: Given SC~gp100:209-217(210M) peptide vaccine: Given SC~laboratory biomarker analysis: Correlative studies"
1263318|NCT00003869|O1|Outcome|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
1263319|NCT00003869|O2|Outcome|Placebo|250 mg placebo administered daily
1263292|NCT00003895|P1|Participant Flow|gp100:209-217(210M)and HPV 16 E7:12-20 (Every 2 Weeks)|"Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 2 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.~HPV 16 E7:12-20 peptide vaccine: Given SC~gp100:209-217(210M) peptide vaccine: Given SC~laboratory biomarker analysis: Correlative studies"
1263293|NCT00003895|O2|Outcome|Arm B (Every 3 Weeks, gp100:209-217(210M) + HPV 16 E7:12-20)|"Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 3 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.~HPV 16 E7:12-20 peptide vaccine: Given SC~gp100:209-217(210M) peptide vaccine: Given SC~laboratory biomarker analysis: Correlative studies"
1263294|NCT00003895|O1|Outcome|Arm A (Every 2 Weeks, gp100:209-217(210M) and HPV 16 E7:12-20)|"Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 2 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.~HPV 16 E7:12-20 peptide vaccine: Given SC~gp100:209-217(210M) peptide vaccine: Given SC~laboratory biomarker analysis: Correlative studies"
1263295|NCT00003895|E2|Reported Event|Arm B (Every 3 Weeks)|"Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 3 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.~HPV 16 E7:12-20 peptide vaccine: Given SC~gp100:209-217(210M) peptide vaccine: Given SC~laboratory biomarker analysis: Correlative studies"
1263296|NCT00003895|E1|Reported Event|Arm A (Every 2 Weeks)|"Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 2 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.~HPV 16 E7:12-20 peptide vaccine: Given SC~gp100:209-217(210M) peptide vaccine: Given SC~laboratory biomarker analysis: Correlative studies"
1263297|NCT00003875|B1|Baseline|Treatment (Chemo, Stem Cell Rescue, Interleukin Therapy)|"PREPARATIVE REGIMEN: Patients receive busulfan IV over 2 hours or PO every 6 hours on days -7 to -4 and etoposide IV on day -3.~STEM CELL INFUSION: Patients undergo autologous or syngeneic PBSC rescue on day 0.~POST-TRANSPLANT ALDESLEUKIN THERAPY: Beginning 30-100 days after transplant, patients receive low-dose aldesleukin SC daily for 12 weeks.~busulfan: Given PO or IV~etoposide: Given IV~aldesleukin: Given SC~peripheral blood stem cell transplantation: Undergo autologous or syngeneic stem cell rescue"
1263298|NCT00003875|P1|Participant Flow|Treatment (Chemo, Stem Cell Rescue, Interleukin Therapy)|"PREPARATIVE REGIMEN: Patients receive busulfan IV over 2 hours or PO every 6 hours on days -7 to -4 and etoposide IV on day -3.~STEM CELL INFUSION: Patients undergo autologous or syngeneic PBSC rescue on day 0.~POST-TRANSPLANT ALDESLEUKIN THERAPY: Beginning 30-100 days after transplant, patients receive low-dose aldesleukin SC daily for 12 weeks.~busulfan: Given PO or IV~etoposide: Given IV~aldesleukin: Given SC~peripheral blood stem cell transplantation: Undergo autologous or syngeneic stem cell rescue"
1263299|NCT00003875|O1|Outcome|Treatment (Chemo, Stem Cell Rescue, Interleukin Therapy)|"PREPARATIVE REGIMEN: Patients receive busulfan IV over 2 hours or PO every 6 hours on days -7 to -4 and etoposide IV on day -3.~STEM CELL INFUSION: Patients undergo autologous or syngeneic PBSC rescue on day 0.~POST-TRANSPLANT ALDESLEUKIN THERAPY: Beginning 30-100 days after transplant, patients receive low-dose aldesleukin SC daily for 12 weeks.~busulfan: Given PO or IV~etoposide: Given IV~aldesleukin: Given SC~peripheral blood stem cell transplantation: Undergo autologous or syngeneic stem cell rescue"
1263300|NCT00003875|O1|Outcome|Treatment (Chemo, Stem Cell Rescue, Interleukin Therapy)|"PREPARATIVE REGIMEN: Patients receive busulfan IV over 2 hours or PO every 6 hours on days -7 to -4 and etoposide IV on day -3.~STEM CELL INFUSION: Patients undergo autologous or syngeneic PBSC rescue on day 0.~POST-TRANSPLANT ALDESLEUKIN THERAPY: Beginning 30-100 days after transplant, patients receive low-dose aldesleukin SC daily for 12 weeks.~busulfan: Given PO or IV~etoposide: Given IV~aldesleukin: Given SC~peripheral blood stem cell transplantation: Undergo autologous or syngeneic stem cell rescue"
1263301|NCT00003875|O1|Outcome|Treatment (Chemo, Stem Cell Rescue, Interleukin Therapy)|"PREPARATIVE REGIMEN: Patients receive busulfan IV over 2 hours or PO every 6 hours on days -7 to -4 and etoposide IV on day -3.~STEM CELL INFUSION: Patients undergo autologous or syngeneic PBSC rescue on day 0.~POST-TRANSPLANT ALDESLEUKIN THERAPY: Beginning 30-100 days after transplant, patients receive low-dose aldesleukin SC daily for 12 weeks.~busulfan: Given PO or IV~etoposide: Given IV~aldesleukin: Given SC~peripheral blood stem cell transplantation: Undergo autologous or syngeneic stem cell rescue"
1263302|NCT00003875|O1|Outcome|Treatment (Chemo, Stem Cell Rescue, Interleukin Therapy)|"PREPARATIVE REGIMEN: Patients receive busulfan IV over 2 hours or PO every 6 hours on days -7 to -4 and etoposide IV on day -3.~STEM CELL INFUSION: Patients undergo autologous or syngeneic PBSC rescue on day 0.~POST-TRANSPLANT ALDESLEUKIN THERAPY: Beginning 30-100 days after transplant, patients receive low-dose aldesleukin SC daily for 12 weeks.~busulfan: Given PO or IV~etoposide: Given IV~aldesleukin: Given SC~peripheral blood stem cell transplantation: Undergo autologous or syngeneic stem cell rescue"
1263303|NCT00003875|E1|Reported Event|Treatment|"PREPARATIVE REGIMEN: Patients receive busulfan IV over 2 hours or PO every 6 hours on days -7 to -4 and etoposide IV on day -3.~STEM CELL INFUSION: Patients undergo autologous or syngeneic PBSC rescue on day 0.~POST-TRANSPLANT ALDESLEUKIN THERAPY: Beginning 30-100 days after transplant, patients receive low-dose aldesleukin SC daily for 12 weeks.~busulfan: Given PO or IV~etoposide: Given IV~aldesleukin: Given SC~peripheral blood stem cell transplantation: Undergo autologous or syngeneic stem cell rescue"
1263304|NCT00003869|B3|Baseline|Total|Total of all reporting groups
1263305|NCT00003869|B2|Baseline|Placebo|250 mg placebo administered daily
1263306|NCT00003869|B1|Baseline|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
1263307|NCT00003869|P2|Participant Flow|Placebo|250 mg placebo administered daily
1263308|NCT00003869|P1|Participant Flow|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
1263309|NCT00003869|O2|Outcome|Placebo|250 mg placebo administered daily
1263310|NCT00003869|O1|Outcome|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
1263311|NCT00003869|O2|Outcome|Placebo|250 mg placebo administered daily
1263312|NCT00003869|O1|Outcome|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
1263313|NCT00003869|O2|Outcome|Placebo|250 mg placebo administered daily
1263314|NCT00003869|O1|Outcome|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
1263315|NCT00003869|O2|Outcome|Placebo|250 mg placebo administered daily
1263321|NCT00003869|E2|Reported Event|Placebo|250 mg placebo administered daily
1263322|NCT00003869|E1|Reported Event|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
1263323|NCT00003820|B1|Baseline|Rituximab 375 mg/m2 Per Week|Rituximab 375 mg/m2 per week by IV infusion for 4 consecutive weeks
1263324|NCT00003820|P2|Participant Flow|Rituximab 375 mg/m2 Per Week Secondary Group|"Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks, every 6 months~Secondary Group of participants were added after the addition of the three extra cycle treatments."
1263325|NCT00003820|P1|Participant Flow|Rituximab 375 mg/m2 Per Week Inital Group|"Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks, every 6 months~Initial Group of participants prior to the addition of the three extra cycle treatments."
1263326|NCT00003820|O1|Outcome|Rituximab 375 mg/m2 Per Week|375 mg/m2 rituximab by IV infusion weekly, assessed after 4 weeks of treatment
1263327|NCT00003820|O1|Outcome|Rituximab 375 mg/m2 Per Week|Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks
1263328|NCT00003820|O1|Outcome|Rituximab 375 mg/m2 Per Week|Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks every 6 months, for up to 4 treatment cycles
1263329|NCT00003820|E1|Reported Event|Rituximab 375 mg/m2 Per Week|"Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks, every 6 months for 2 years.~This was a single-arm study with multiple treatment periods added by amendment (ie, Secondary Group), with results reported by treatment period. As this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group."
1263330|NCT00003782|B4|Baseline|Total|Total of all reporting groups
1263331|NCT00003782|B3|Baseline|Doxorubicin + Docetaxel + Cyclophosphamide|Doxorubicin + Docetaxel + Cyclophosphamide
1263332|NCT00003782|B2|Baseline|Doxorubicin + Docetaxel|Doxorubicin + Docetaxel
1263333|NCT00003782|B1|Baseline|Doxorubicin + Cyclophosphamide, Then Docetaxel|Doxorubicin + Cyclophosphamide, then Docetaxel
1263334|NCT00003782|P3|Participant Flow|Arm 3: Doxorubicin + Docetaxel + Cyclophosphamide|Doxorubicin + Docetaxel + Cyclophosphamide
1263335|NCT00003782|P2|Participant Flow|Arm 2: Doxorubicin + Docetaxel|Doxorubicin + Docetaxel
1263336|NCT00003782|P1|Participant Flow|Arm 1: Doxorubicin + Cyclophosphamide, Then Docetaxel|Doxorubicin + Cyclophosphamide, then Docetaxel
1263337|NCT00003782|O3|Outcome|Arm 3: Doxorubicin + Docetaxel + Cyclophosphamide|Doxorubicin + Docetaxel + Cyclophosphamide
1263338|NCT00003782|O2|Outcome|Arm 2: Doxorubicin + Docetaxel|Doxorubicin + Docetaxel
1263339|NCT00003782|O1|Outcome|Arm 1: Doxorubicin + Cyclophosphamide, Then Docetaxel|Doxorubicin + Cyclophosphamide, then Docetaxel
1263340|NCT00003782|E3|Reported Event|Doxorubicin + Docetaxel + Cyclophosphamide|Doxorubicin + Docetaxel + Cyclophosphamide
1263341|NCT00003782|E2|Reported Event|Doxorubicin + Docetaxel|Doxorubicin + Docetaxel
1263342|NCT00003782|E1|Reported Event|Doxorubicin + Cyclophosphamide, Then Docetaxel|Doxorubicin + Cyclophosphamide, then Docetaxel
1263343|NCT00003726|B1|Baseline|Lepirudin|Dose level 1: 10 mg once daily -> (total dose, 10 mg/d) Dose level 2: 15 mg once daily -> (total dose, 15 mg/d) Dose level 3: 10 mg twice daily -> (total dose, 20 mg/d) Dose level 4: 15 mg twice daily -> (total dose, 30 mg/d) Dose level 5. 20 mg twice daily -> (total dose, 40 mg/d) Dose level 6: 25 mg twice daily -> (total dose, 50 mg/d)
1263344|NCT00003726|P1|Participant Flow|Lepirudin|Dose level 1: 10 mg once daily -> (total dose, 10 mg/d) Dose level 2: 15 mg once daily -> (total dose, 15 mg/d) Dose level 3: 10 mg twice daily -> (total dose, 20 mg/d) Dose level 4: 15 mg twice daily -> (total dose, 30 mg/d) Dose level 5. 20 mg twice daily -> (total dose, 40 mg/d) Dose level 6: 25 mg twice daily -> (total dose, 50 mg/d)
1263345|NCT00003726|O1|Outcome|Lepirudin|Dose level 1: 10 mg once daily -> (total dose, 10 mg/d) Dose level 2: 15 mg once daily -> (total dose, 15 mg/d) Dose level 3: 10 mg twice daily -> (total dose, 20 mg/d) Dose level 4: 15 mg twice daily -> (total dose, 30 mg/d) Dose level 5. 20 mg twice daily -> (total dose, 40 mg/d) Dose level 6: 25 mg twice daily -> (total dose, 50 mg/d)
1263346|NCT00003726|E1|Reported Event|Lepirudin|Dose level 1: 10 mg once daily -> (total dose, 10 mg/d) Dose level 2: 15 mg once daily -> (total dose, 15 mg/d) Dose level 3: 10 mg twice daily -> (total dose, 20 mg/d) Dose level 4: 15 mg twice daily -> (total dose, 30 mg/d) Dose level 5. 20 mg twice daily -> (total dose, 40 mg/d) Dose level 6: 25 mg twice daily -> (total dose, 50 mg/d)
1263347|NCT00003659|B1|Baseline|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
1263348|NCT00003659|P1|Participant Flow|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
1263349|NCT00003659|O1|Outcome|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
1263350|NCT00003659|O1|Outcome|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
1263351|NCT00003659|O1|Outcome|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
1263352|NCT00003659|E1|Reported Event|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
1263353|NCT00003641|B3|Baseline|Total|Total of all reporting groups
1263354|NCT00003641|B2|Baseline|Interferon Alfa-2b|"Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.~interferon alfa-2b: Given IV"
1263355|NCT00003641|B1|Baseline|Observation|Patients undergo observation for 4 weeks.
1263476|NCT00003377|O1|Outcome|Arm 2, P I & II|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
1263486|NCT00003377|E2|Reported Event|Arm 2, P I|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
1263356|NCT00003641|P2|Participant Flow|Interferon Alfa-2b|"Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.~interferon alfa-2b: Given IV"
1263357|NCT00003641|P1|Participant Flow|Observation|Patients undergo observation for 4 weeks.
1263358|NCT00003641|O2|Outcome|Interferon Alfa-2b|"Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.~interferon alfa-2b: Given IV"
1263359|NCT00003641|O1|Outcome|Observation|Patients undergo observation for 4 weeks.
1263360|NCT00003641|O2|Outcome|Interferon Alfa-2b|"Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.~interferon alfa-2b: Given IV"
1263361|NCT00003641|O1|Outcome|Observation|Patients undergo observation for 4 weeks.
1263362|NCT00003641|E2|Reported Event|Interferon Alfa-2b|Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days
1263363|NCT00003641|E1|Reported Event|Observation|Patients undergo observation for 4 weeks
1263364|NCT00003631|B4|Baseline|Total|Total of all reporting groups
1263365|NCT00003631|B3|Baseline|Group C - Unfavorable Prognostic Group|
1263366|NCT00003631|B2|Baseline|Group B - Intermediate Prognostic Group|
1263367|NCT00003631|B1|Baseline|Group A - Favorable Prognostic Group|
1263368|NCT00003631|P3|Participant Flow|Group C - Unfavorable Prognostic Group|
1263369|NCT00003631|P2|Participant Flow|Group B - Intermediate Prognostic Group|
1263370|NCT00003631|P1|Participant Flow|Group A - Favorable Prognostic Group|
1263371|NCT00003631|O3|Outcome|Group C - Unfavorable Prognostic Group|
1263372|NCT00003631|O2|Outcome|Group B - Intermediate Prognostic Group|
1263373|NCT00003631|O1|Outcome|Group A - Favorable Prognostic Group|
1263374|NCT00003631|E3|Reported Event|Group C - Unfavorable Prognostic Group|
1263375|NCT00003631|E2|Reported Event|Group B - Intermediate Prognostic Group|
1263376|NCT00003631|E1|Reported Event|Group A - Favorable Prognostic Group|
1263377|NCT00003590|B1|Baseline|Hydroxyurea|"Only eligible patients were included in the analyses.~Patients received 20 mg/kg/day taken orally."
1263378|NCT00003590|P1|Participant Flow|Hydroxyurea|"Only eligible patients were included in the analyses.~Patients received 20 mg/kg/day taken orally."
1263379|NCT00003590|O1|Outcome|Hydroxyurea|Patients received 20 mg/kg/day PO.
1263380|NCT00003590|O1|Outcome|Hydroxyurea|Patients received 20 mg/kg/day PO.
1263381|NCT00003590|E1|Reported Event|Hydroxyurea|Patients received Hydroxyurea (20 mg/kg/day orally) up to 2 years in absence of progressive disease.
1263382|NCT00003537|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a residual or recurrent anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263383|NCT00003537|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a residual or recurrent anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263384|NCT00003537|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a residual or recurrent anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263385|NCT00003537|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a residual or recurrent anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263386|NCT00003537|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with an anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263387|NCT00003483|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263388|NCT00003483|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263389|NCT00003483|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263390|NCT00003483|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263391|NCT00003483|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263392|NCT00003479|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263393|NCT00003479|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263394|NCT00003479|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263395|NCT00003479|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263396|NCT00003479|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263397|NCT00003477|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a visual pathway glioma, which is not amenable to standard therapy or has not responded to standard therapy, will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263398|NCT00003477|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a visual pathway glioma, which is not amenable to standard therapy or has not responded to standard therapy, will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263399|NCT00003477|O1|Outcome|Antineoplaston Therapy|Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
1263400|NCT00003477|O1|Outcome|Antineoplaston Therapy|Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
1263401|NCT00003477|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with a visual pathway glioma will receive Antineoplaston therapy (Atengenal + Astugenal)"
1263402|NCT00003476|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a primary malignant brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263403|NCT00003476|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a primary malignant brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263404|NCT00003476|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a primary malignant brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263405|NCT00003476|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a primary malignant brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263406|NCT00003476|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a primary malignant brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263407|NCT00003475|B1|Baseline|Antineoplaston Therpay|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263408|NCT00003475|P1|Participant Flow|Antineoplaston Therpay|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263409|NCT00003475|O1|Outcome|Antineoplaston Therpay|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263410|NCT00003475|O1|Outcome|Antineoplaston Therpay|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
1263411|NCT00003475|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
1263412|NCT00003473|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263413|NCT00003473|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal, to mitigate adverse reactions to treatment, until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263414|NCT00003473|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263415|NCT00003473|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263416|NCT00003473|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263417|NCT00003470|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with an anaplastic astrocytoma that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
1263418|NCT00003470|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with an anaplastic astrocytoma that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263419|NCT00003470|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with an anaplastic astrocytoma that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
1263420|NCT00003470|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with an anaplastic astrocytoma that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
1263421|NCT00003470|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with an anaplastic astrocytoma that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263422|NCT00003469|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a Rhabdoid tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263423|NCT00003469|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a Rhabdoid tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263477|NCT00003377|O1|Outcome|Arm 2, P I & II|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
1263478|NCT00003377|O5|Outcome|Arm 2, PII|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
1263479|NCT00003377|O4|Outcome|Arm 4, P I|Cisplatin 30 mg/m2, plus Paclitaxel 50 mg/m2
1263424|NCT00003469|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a Rhabdoid tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263425|NCT00003469|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a Rhabdoid tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263426|NCT00003469|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a Rhabdoid tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263427|NCT00003468|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263428|NCT00003468|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Children with a low-grade astrocytoma who have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263429|NCT00003468|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263430|NCT00003468|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263431|NCT00003468|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263432|NCT00003460|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a primitive neuroectodermal tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263433|NCT00003460|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a primitive neuroectodermal tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263434|NCT00003460|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a primitive neuroectodermal tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263435|NCT00003460|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a primitive neuroectodermal tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263436|NCT00003460|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a primitive neuroectodermal tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263437|NCT00003459|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dosage is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)"
1263438|NCT00003459|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dosage is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)"
1263439|NCT00003459|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dosage is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)"
1263440|NCT00003459|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dosage is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)"
1263441|NCT00003459|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dosage is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)"
1263442|NCT00003458|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263443|NCT00003458|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263444|NCT00003458|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263445|NCT00003458|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263446|NCT00003458|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263447|NCT00003457|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263448|NCT00003457|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263449|NCT00003457|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263450|NCT00003457|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263451|NCT00003457|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
1263452|NCT00003389|B3|Baseline|Total|Total of all reporting groups
1263453|NCT00003389|B2|Baseline|Arm B (Stanford V)|Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.
1263454|NCT00003389|B1|Baseline|Arm A (ABVD)|Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.
1263455|NCT00003389|P2|Participant Flow|Arm B (Stanford V)|"Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.~Doxorubicin: given IV~Bleomycin: given IV~Vinblastine: given IV~Vincristine: given IV~Mechlorethamine: given IV~Etoposide: given IV~Prednisone: taken orally~Cyclophosphamide: given IV~Radiotherapy"
1263480|NCT00003377|O3|Outcome|Arm 3, P I|Cisplatin 40 mg/m2, plus Paclitaxel 50 mg/m2
1263481|NCT00003377|O2|Outcome|Arm 2, P I|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
1263482|NCT00003377|O1|Outcome|Arm 1, P I|Cisplatin 40 mg/m2, plus Paclitaxel 30 mg/m2
1263483|NCT00003377|E5|Reported Event|Arm 2, P II|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
1263484|NCT00003377|E4|Reported Event|Arm 4, P I|Cisplatin 30 mg/m2, plus Paclitaxel 50 mg/m2
1263485|NCT00003377|E3|Reported Event|Arm 3, P I|Cisplatin 40 mg/m2, plus Paclitaxel 50 mg/m2
1263456|NCT00003389|P1|Participant Flow|Arm A (ABVD)|"Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.~Doxorubicin: given IV~Bleomycin: given IV~Vinblastine: given IV~Dacarbazine: given IV~Radiotherapy"
1263457|NCT00003389|O2|Outcome|Arm B (Stanford V)|Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.
1263458|NCT00003389|O1|Outcome|Arm A (ABVD)|Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.
1263459|NCT00003389|O2|Outcome|Arm B (Stanford V)|Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.
1263460|NCT00003389|O1|Outcome|Arm A (ABVD)|Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.
1263461|NCT00003389|O2|Outcome|Arm B (Stanford V)|Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.
1263462|NCT00003389|O1|Outcome|Arm A (ABVD)|Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.
1263463|NCT00003389|E2|Reported Event|Arm B (Stanford V)|Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.
1263464|NCT00003389|E1|Reported Event|Arm A (ABVD)|Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.
1263465|NCT00003377|B6|Baseline|Total|Total of all reporting groups
1263466|NCT00003377|B5|Baseline|Arm 4, P I|Cisplatin 30 mg/m2, plus Paclitaxel 50 mg/m2
1263467|NCT00003377|B4|Baseline|Arm 3, P I|Cisplatin 40 mg/m2, plus Paclitaxel 50 mg/m2
1263468|NCT00003377|B3|Baseline|Arm 2, P II|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
1263469|NCT00003377|B2|Baseline|Arm 2, P I|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
1263470|NCT00003377|B1|Baseline|Arm 1, P I|Cisplatin 40 mg/m2, plus Paclitaxel 30 mg/m2
1263471|NCT00003377|P5|Participant Flow|Arm 2, P II|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
1263472|NCT00003377|P4|Participant Flow|Arm 4, P I|Cisplatin 30 mg/m2, plus Paclitaxel 50 mg/m2
1263473|NCT00003377|P3|Participant Flow|Arm 3, P I|Cisplatin 40 mg/m2, plus Paclitaxel 50 mg/m2
1263474|NCT00003377|P2|Participant Flow|Arm 2, P I|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
1263475|NCT00003377|P1|Participant Flow|Arm 1, P I|Cisplatin 40 mg/m2, plus Paclitaxel 30 mg/m2
1263487|NCT00003377|E1|Reported Event|Arm 1, P I|Cisplatin 40 mg/m2, plus Paclitaxel 30 mg/m2
1263488|NCT00003298|B1|Baseline|Experimental Arm|Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
1263489|NCT00003298|P1|Participant Flow|Experimental Arm|Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
1263490|NCT00003298|O1|Outcome|Experimental Arm|Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
1263491|NCT00003298|O1|Outcome|Experimental Arm|Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
1263492|NCT00003298|O1|Outcome|Experimental Arm|Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
1263493|NCT00003298|O1|Outcome|Experimental Arm|Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
1263494|NCT00003298|E2|Reported Event|Step 2 (Adjuvant Therapy)|After neoadjuvant therapy, patients undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
1263495|NCT00003298|E1|Reported Event|Step 1(Neoadjuvant Therapy)|Patients receive 3 courses of preoperative neoadjuvant chemotherapy given on day 1 every 21 days. Courses consist of an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel on day 1.
1263496|NCT00003224|B7|Baseline|Total|Total of all reporting groups
1263497|NCT00003224|B6|Baseline|Group 6. p946/Tet-p Plus IFA|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
1263498|NCT00003224|B5|Baseline|Group 5: p946/Tet-p Plus QS-21|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
1263499|NCT00003224|B4|Baseline|Group 4. p946, Tet-p Plus IFA|100 mcg peptide gp100 [280-288], 190 mcg tetanus peptide, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
1263500|NCT00003224|B3|Baseline|Group 3: p946 Plus Tet-p Plus QS-21|100 mcg peptide gp100 [280-288],190 mcg tetanus peptide, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
1263501|NCT00003224|B2|Baseline|Group 2. p946 Plus IFA|100 mcg peptide gp100 [280-288] plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
1263502|NCT00003224|B1|Baseline|Group 1: Peptide 946 Plus QS-21|100 mcg peptide gp100 [280-288] plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
1263503|NCT00003224|P6|Participant Flow|Group 6. p946/Tet-p Plus IFA|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
1263504|NCT00003224|P5|Participant Flow|Group 5: p946/Tet-p Plus QS-21|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
1263505|NCT00003224|P4|Participant Flow|Group 4. p946, Tet-p Plus IFA|100 mcg peptide gp100 [280-288], 190 mcg tetanus peptide, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
1263506|NCT00003224|P3|Participant Flow|Group 3: p946 Plus Tet-p Plus QS-21|100 mcg peptide gp100 [280-288],190 mcg tetanus peptide, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
1263507|NCT00003224|P2|Participant Flow|Group 2. p946 Plus IFA|100 mcg peptide gp100 [280-288] plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
1263508|NCT00003224|P1|Participant Flow|Group 1: Peptide 946 Plus QS-21|100 mcg peptide gp100 [280-288] plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
1263509|NCT00003224|O6|Outcome|Group 6. p946/Tet-p Plus IFA|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
1264032|NCT00000479|B4|Baseline|Both Placebos|Placebo aspirin and placebo vitamin E
1263510|NCT00003224|O5|Outcome|Group 5: p946/Tet-p Plus QS-21|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
1263511|NCT00003224|O4|Outcome|Group 4. p946, Tet-p Plus IFA|100 mcg peptide gp100 [280-288], 190 mcg tetanus peptide, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
1263512|NCT00003224|O3|Outcome|Group 3: p946 Plus Tet-p Plus QS-21|100 mcg peptide gp100 [280-288],190 mcg tetanus peptide, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
1263513|NCT00003224|O2|Outcome|Group 2. p946 Plus IFA|100 mcg peptide gp100 [280-288] plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
1263514|NCT00003224|O1|Outcome|Group 1: Peptide 946 Plus QS-21|100 mcg peptide gp100 [280-288] plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
1263515|NCT00003224|O6|Outcome|Group 6. p946/Tet-p Plus IFA|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
1263516|NCT00003224|O5|Outcome|Group 5: p946/Tet-p Plus QS-21|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
1263517|NCT00003224|O4|Outcome|Group 4. p946, Tet-p Plus IFA|100 mcg peptide gp100 [280-288], 190 mcg tetanus peptide, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
1263518|NCT00003224|O3|Outcome|Group 3: p946 Plus Tet-p Plus QS-21|100 mcg peptide gp100 [280-288],190 mcg tetanus peptide, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
1263519|NCT00003224|O2|Outcome|Group 2. p946 Plus IFA|100 mcg peptide gp100 [280-288] plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
1263520|NCT00003224|O1|Outcome|Group 1: Peptide 946 Plus QS-21|100 mcg peptide gp100 [280-288] plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
1263521|NCT00003224|O2|Outcome|All Montanide ISA-51|The toxicities are grouped for those receiving the vaccine adjuvant IFA (Montanide ISA-51).
1263522|NCT00003224|O1|Outcome|All QS-21|The toxicities are grouped for those receiving the vaccine adjuvant QS-21.
1263523|NCT00003224|E2|Reported Event|Montanide ISA-51 Adjuvant|The combination of participants from Arms 2, 4, and 6, all treated with peptides plus Montanide ISA-51 adjuvant
1263524|NCT00003224|E1|Reported Event|QS-21 Adjuvant|The combination of participants from Arms 1, 3, and 5, all treated with peptides plus QS-21 adjuvant
1263525|NCT00003222|B3|Baseline|Total|Total of all reporting groups
1263526|NCT00003222|B2|Baseline|Peptides in GMCSF-in-adjuvant|
1263527|NCT00003222|B1|Baseline|Peptides Pulsed on Dendritic Cells|
1263528|NCT00003222|P2|Participant Flow|Peptides in Sargramostim (GMCSF)-In-Montanide ISA-51 Adjuvant|---Peptides were administered in an emulsion of sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's) adjuvant
1263529|NCT00003222|P1|Participant Flow|Peptides Pulsed on Dendritic Cells|---peptides were pulsed on monocyte-derived dendritic cells cultures in GM-CSF and IL-4
1263530|NCT00003222|O2|Outcome|Peptides in GMCSF-in-adjuvant|
1263531|NCT00003222|O1|Outcome|Peptides Pulsed on Dendritic Cells|
1263532|NCT00003222|O2|Outcome|Peptides in GMCSF-in-adjuvant|
1263533|NCT00003222|O1|Outcome|Peptides Pulsed on Dendritic Cells|
1263534|NCT00003222|O2|Outcome|Peptides in GMCSF-in-adjuvant|
1263535|NCT00003222|O1|Outcome|Peptides Pulsed on Dendritic Cells|
1263536|NCT00003222|E2|Reported Event|Peptides in GMCSF-in-adjuvant|
1263537|NCT00003222|E1|Reported Event|Peptides Pulsed on Dendritic Cells|
1263538|NCT00003199|B1|Baseline|Arm I|"See Detailed Description.~tamoxifen citrate: Given orally~busulfan: Given orally~thiotepa: Given IV~melphalan: Given IV~aldesleukin: Given SC~sargramostim: Given SC~peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell infusion~radiation therapy: May undergo radiotherapy after completion of IL-2/GM-CSF"
1263539|NCT00003199|P1|Participant Flow|Arm I|"See Detailed Description.~tamoxifen citrate: Given orally~busulfan: Given orally~thiotepa: Given IV~melphalan: Given IV~aldesleukin: Given SC~sargramostim: Given SC~peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell infusion~radiation therapy: May undergo radiotherapy after completion of IL-2/GM-CSF"
1263540|NCT00003199|O1|Outcome|Arm I|"See Detailed Description.~tamoxifen citrate: Given orally~busulfan: Given orally~thiotepa: Given IV~melphalan: Given IV~aldesleukin: Given SC~sargramostim: Given SC~peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell infusion~radiation therapy: May undergo radiotherapy after completion of IL-2/GM-CSF"
1263541|NCT00003199|O1|Outcome|Arm I|"See Detailed Description.~tamoxifen citrate: Given orally~busulfan: Given orally~thiotepa: Given IV~melphalan: Given IV~aldesleukin: Given SC~sargramostim: Given SC~peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell infusion~radiation therapy: May undergo radiotherapy after completion of IL-2/GM-CSF"
1263542|NCT00003199|O1|Outcome|Arm I|"See Detailed Description.~tamoxifen citrate: Given orally~busulfan: Given orally~thiotepa: Given IV~melphalan: Given IV~aldesleukin: Given SC~sargramostim: Given SC~peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell infusion~radiation therapy: May undergo radiotherapy after completion of IL-2/GM-CSF"
1263543|NCT00003199|E1|Reported Event|Arm I|"See Detailed Description.~tamoxifen citrate: Given orally~busulfan: Given orally~thiotepa: Given IV~melphalan: Given IV~aldesleukin: Given SC~sargramostim: Given SC~peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell infusion~radiation therapy: May undergo radiotherapy after completion of IL-2/GM-CSF"
1263544|NCT00003138|B3|Baseline|Total|Total of all reporting groups
1263545|NCT00003138|B2|Baseline|Erythropoietin|Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
1263546|NCT00003138|B1|Baseline|Supportive Care|Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of >= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
1263547|NCT00003138|P2|Participant Flow|Erythropoietin|Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
1263580|NCT00002850|E3|Reported Event|Observation|No Prophylaxis: The patient will receive no prophylactic antibiotics.
1263881|NCT00001596|O2|Outcome|Placebo|Subjects received placebo (3 pills), three times daily.
1263548|NCT00003138|P1|Participant Flow|Supportive Care|Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of >= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
1263549|NCT00003138|O2|Outcome|Erythropoietin|Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
1263550|NCT00003138|O1|Outcome|Supportive Care|Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of >= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
1263551|NCT00003138|O2|Outcome|Erythropoietin|Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
1263552|NCT00003138|O1|Outcome|Supportive Care|Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of >= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
1263553|NCT00003138|O2|Outcome|Erythropoietin|Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
1263554|NCT00003138|O1|Outcome|Supportive Care|Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of >= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
1263555|NCT00003138|E5|Reported Event|Erythropoietin (300 Units/kg) and Filgrastim (Step 4)|All patients received erythropoietin (150 units/kg) and filgrastim may, at progression or at stable disease with continued transfusion requirement following 4 months of therapy, increased their dose of erythropoietin to 300 units/kg.
1263556|NCT00003138|E4|Reported Event|Erythropoietin (150 Units/kg) and Filgrastim (Step 3)|All patients received erythropoietin alone treatment may, at progression or at stable disease with continued transfusion requirement following 4 months of therapy, add filgrastim.
1263557|NCT00003138|E3|Reported Event|Erythropoietin (Cross-over; Step 2)|Patients in the supportive care arm who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of >= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm. Erythropoietin was administered at 150 units/kg subcutaneously every day.
1263558|NCT00003138|E2|Reported Event|Erythropoietin (Step 1)|Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
1263559|NCT00003138|E1|Reported Event|Supportive Care (Step 1)|Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of >= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
1263560|NCT00002975|B1|Baseline|Photodynamic Therapy Using 20% Topical ALA|4-6h and 18-24h, 20%, ALA application of superficial and nodular epidermally-derived lesions using ca 633 nm laser irradiation
1263561|NCT00002975|P1|Participant Flow|Photodynamic Therapy Using 20% Topical ALA|4-6h and 18-24h, 20%, ALA application of superficial and nodular epidermally-derived lesions using ca 633 nm laser irradiation
1263562|NCT00002975|O1|Outcome|Photodynamic Therapy Using 20% Topical ALA|4-6h and 18-24h, 20%, ALA application of superficial and nodular epidermally-derived lesions using ca 633 nm laser irradiation
1263563|NCT00002975|E1|Reported Event|Photodynamic Therapy Using 20% Topical ALA|4-6h and 18-24h, 20%, ALA application of superficial and nodular epidermally-derived lesions using ca 633 nm laser irradiation
1263564|NCT00002931|B1|Baseline|HD Chemo and Auto Stem Cells|Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
1263565|NCT00002931|P1|Participant Flow|HD Chemo and Auto Stem Cells|Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
1263657|NCT00002558|E1|Reported Event|Group A: <= 6 Cycles of Cisplatin|Group A: Prior Treatment Limited to <= 6 Cycles of Cisplatin
1263566|NCT00002931|O1|Outcome|HD Chemo and Auto Stem Cells|Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
1263567|NCT00002931|O1|Outcome|HD Chemo and Auto Stem Cells|Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
1263568|NCT00002931|O1|Outcome|HD Chemo and Auto Stem Cells|Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
1263569|NCT00002931|E1|Reported Event|HD Chemo and Auto Stem Cells|Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
1263570|NCT00002850|B4|Baseline|Total|Total of all reporting groups
1263571|NCT00002850|B3|Baseline|Observation|No prophylaxis: The patient will receive no prophylactic antibiotics.
1263572|NCT00002850|B2|Baseline|TMP-SMX|trimethoprim-sulfamethoxazole: Begin oral Trimethoprim-sulfamethoxazole when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet [TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole] every 12 hours for two months..
1263573|NCT00002850|B1|Baseline|Ciprofloxacin or Ofloxacin|"ciprofloxacin: Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro® 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.~ofloxacin: Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy."
1263574|NCT00002850|P3|Participant Flow|Observation|Patients observed without intervention and evaluated for SBI for the first 2 months of treatment.
1263575|NCT00002850|P2|Participant Flow|TMP-SMX|trimethoprim-sulfamethoxazole: Begin oral Trimethoprim-sulfamethoxazole when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet [TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole] every 12 hours for two months..
1263576|NCT00002850|P1|Participant Flow|Ciprofloxacin or Ofloxacin|"ciprofloxacin: Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro® 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.~ofloxacin: Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy."
1263577|NCT00002850|O3|Outcome|No Prophylaxis|The patient will receive no prophylactic antibiotics.
1263578|NCT00002850|O2|Outcome|TMP-SMX|trimethoprim-sulfamethoxazole: Begin oral Trimethoprim-sulfamethoxazole when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet [TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole] every 12 hours for two months..
1263579|NCT00002850|O1|Outcome|Ciprofloxacin or Ofloxacin|"ciprofloxacin: Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro® 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.~ofloxacin: Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy."
1263658|NCT00002540|B3|Baseline|Total|Total of all reporting groups
1263581|NCT00002850|E2|Reported Event|TMP-SMX|trimethoprim-sulfamethoxazole: Begin oral Trimethoprim-sulfamethoxazole when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet [TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole] every 12 hours for two months..
1263582|NCT00002850|E1|Reported Event|Ciprofloxacin or Ofloxacin|"ciprofloxacin: Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro® 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.~ofloxacin: Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy."
1263583|NCT00002842|B1|Baseline|Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin|"Patients receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4 weeks for a total of 12 weeks~floxuridine: Starting dose of 0.2 mg/kg/day for 14 consecutive days.~fluorouracil: 300 mg/m2/day by intravenous bolus 24 hours apart for 5 consecutive days.~leucovorin calcium: 500 mg/m2/day by continuous intravenous infusion beginning 24 hours prior to the first dose of 5-FU and continuing until 12 hours following the last dose of 5-FU.~adjuvant therapy: Chemotherapy given after hepatic resection~conventional surgery: Hepatic resection"
1263584|NCT00002842|P1|Participant Flow|Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin|"Patients receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4 weeks for a total of 12 weeks~floxuridine: Starting dose of 0.2 mg/kg/day for 14 consecutive days.~fluorouracil: 300 mg/m2/day by intravenous bolus 24 hours apart for 5 consecutive days.~leucovorin calcium: 500 mg/m2/day by continuous intravenous infusion beginning 24 hours prior to the first dose of 5-FU and continuing until 12 hours following the last dose of 5-FU.~adjuvant therapy: Chemotherapy given after hepatic resection~conventional surgery: Hepatic resection"
1263585|NCT00002842|O1|Outcome|Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin|"Patients receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4 weeks for a total of 12 weeks~floxuridine: Starting dose of 0.2 mg/kg/day for 14 consecutive days.~fluorouracil: 300 mg/m2/day by intravenous bolus 24 hours apart for 5 consecutive days.~leucovorin calcium: 500 mg/m2/day by continuous intravenous infusion beginning 24 hours prior to the first dose of 5-FU and continuing until 12 hours following the last dose of 5-FU.~adjuvant therapy: Chemotherapy given after hepatic resection~conventional surgery: Hepatic resection"
1263586|NCT00002842|E1|Reported Event|Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin|"Patients receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4 weeks for a total of 12 weeks~floxuridine: Starting dose of 0.2 mg/kg/day for 14 consecutive days.~fluorouracil: 300 mg/m2/day by intravenous bolus 24 hours apart for 5 consecutive days.~leucovorin calcium: 500 mg/m2/day by continuous intravenous infusion beginning 24 hours prior to the first dose of 5-FU and continuing until 12 hours following the last dose of 5-FU.~adjuvant therapy: Chemotherapy given after hepatic resection~conventional surgery: Hepatic resection"
1263587|NCT00002766|B3|Baseline|Total|Total of all reporting groups
1263588|NCT00002766|B2|Baseline|L-20|"Standard Vincristine/Prednisone (L-20)"
1263589|NCT00002766|B1|Baseline|All-2|"ARA-C/High-Dose Mitoxantrone(All-2)"
1263590|NCT00002766|P2|Participant Flow|L-20|"Standard Vincristine/Prednisone (L-20) Patients receive induction therapy consisting of vincristine IV on days 1, 8, 15, 22, and 29, oral prednisone 2-3 times daily on days 1-29, cyclophosphamide IV on day 5, doxorubicin IV on days 23-25 and 42, methotrexate intrathecally on days 3, 5, 13, 16, 32, and 34 and GM-CSF subcutaneously or IV over 4 hours beginning from days 7 and 27 and continuing until blood counts recover."
1263591|NCT00002766|P1|Participant Flow|All-2|"ARA-C/High-Dose Mitoxantrone(All-2) Patients receive induction therapy consisting of cytarabine IV over 3 hours on days 1-5 with high-dose mitoxantrone IV on day 3 and methotrexate intrathecally on days 2 and 4. Patients receive sargramostim (GM-CSF) subcutaneously or IV over 4 hours beginning on day 7 and continuing until blood counts recover."
1263592|NCT00002766|O2|Outcome|L-20|"Standard Vincristine/Prednisone (L-20)"
1263593|NCT00002766|O1|Outcome|All-2|"ARA-C/High-Dose Mitoxantrone(All-2)"
1263594|NCT00002766|E2|Reported Event|L-20|"Standard Vincristine/Prednisone (L-20)"
1263595|NCT00002766|E1|Reported Event|All-2|"ARA-C/High-Dose Mitoxantrone(All-2)"
1263596|NCT00002651|B3|Baseline|Total|Total of all reporting groups
1263597|NCT00002651|B2|Baseline|Intermittent Hormonal Therapy|Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29).
1263598|NCT00002651|B1|Baseline|Continuous Hormonal Therapy|Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease
1263599|NCT00002651|P3|Participant Flow|Intermittent Hormonal Therapy|Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29).
1263600|NCT00002651|P2|Participant Flow|Continuous Hormonal Therapy|Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease
1263601|NCT00002651|P1|Participant Flow|Combined Androgen Deprivation (CAD)|Patients receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily for 7 months.
1263602|NCT00002651|O2|Outcome|Intermittent Hormonal Therapy|Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29).
1263603|NCT00002651|O1|Outcome|Continuous Hormonal Therapy|Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease
1263604|NCT00002651|O2|Outcome|Intermittent Hormonal Therapy|Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29).
1263605|NCT00002651|O1|Outcome|Continuous Hormonal Therapy|Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease
1263606|NCT00002651|O2|Outcome|Intermittent Hormonal Therapy|Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29).
1263607|NCT00002651|O1|Outcome|Continuous Hormonal Therapy|Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease
1263608|NCT00002651|O2|Outcome|Intermittent Hormonal Therapy|Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29).
1263609|NCT00002651|O1|Outcome|Continuous Hormonal Therapy|Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease
1263610|NCT00002651|O2|Outcome|Intermittent Hormonal Therapy|Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29).
1263611|NCT00002651|O1|Outcome|Continuous Hormonal Therapy|Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease
1263612|NCT00002651|O2|Outcome|Consolidation Arm II|"Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy as in consolidation arm I. Patients whose PSA normalizes after 8 courses return to observation. Patients whose PSA does not normalize after 8 courses continue CAD therapy.~bicalutamide: Given orally~goserelin acetate: Given subcutaneously~clinical observation: Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease."
1263613|NCT00002651|O1|Outcome|Consolidation Arm I|"Patients continue CAD therapy comprising goserelin subcutaneously once a month and oral bicalutamide once daily. Treatment continues in the absence of disease progression.~bicalutamide: Given orally~goserelin acetate: Given subcutaneously"
1263614|NCT00002651|E2|Reported Event|Intermittent Hormonal Therapy|Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29).
1263615|NCT00002651|E1|Reported Event|Continuous Hormonal Therapy|Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease
1263616|NCT00002601|B1|Baseline|Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT|"Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.~Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused"
1263882|NCT00001596|O1|Outcome|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
1263617|NCT00002601|P1|Participant Flow|Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT|"Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.~Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused"
1263618|NCT00002601|O1|Outcome|Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT|"Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.~Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused"
1263619|NCT00002601|O1|Outcome|Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT|"Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.~Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused"
1263620|NCT00002601|O2|Outcome|Cycle 2|Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused
1263621|NCT00002601|O1|Outcome|Cycle 1|Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.
1263622|NCT00002601|O1|Outcome|Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT|"Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.~Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused"
1263623|NCT00002601|E1|Reported Event|Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT|"Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.~Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused"
1263624|NCT00002597|B3|Baseline|Total|Total of all reporting groups
1263625|NCT00002597|B2|Baseline|Radiation Therapy Alone|Radiation therapy alone
1263626|NCT00002597|B1|Baseline|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
1263627|NCT00002597|P2|Participant Flow|Radiation Therapy Alone|Radiation therapy alone
1263628|NCT00002597|P1|Participant Flow|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
1263629|NCT00002597|O2|Outcome|Radiation Therapy Alone|Radiation therapy alone
1263630|NCT00002597|O1|Outcome|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
1263631|NCT00002597|O2|Outcome|Radiation Therapy Alone|Radiation therapy alone
1263632|NCT00002597|O1|Outcome|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
1263633|NCT00002597|O2|Outcome|Radiation Therapy Alone|Radiation therapy alone
1263634|NCT00002597|O1|Outcome|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
1263635|NCT00002597|O2|Outcome|Radiation Therapy Alone|Radiation therapy alone
1263636|NCT00002597|O1|Outcome|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
1263637|NCT00002597|O2|Outcome|Radiation Therapy Alone|Radiation therapy alone
1263638|NCT00002597|O1|Outcome|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
1263639|NCT00002597|O2|Outcome|Radiation Therapy Alone|Radiation therapy alone
1263640|NCT00002597|O1|Outcome|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
1263641|NCT00002597|O2|Outcome|Radiation Therapy Alone|Radiation therapy alone
1263642|NCT00002597|O1|Outcome|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
1263643|NCT00002597|O2|Outcome|Radiation Therapy Alone|Radiation therapy alone
1263644|NCT00002597|O1|Outcome|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
1263645|NCT00002597|O2|Outcome|Radiation Therapy Alone|Radiation therapy alone
1263646|NCT00002597|O1|Outcome|Hormone Therapy + Radiation Therapy|Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
1263647|NCT00002597|E2|Reported Event|Radiation Therapy Alone|Radiation therapy alone
1263648|NCT00002597|E1|Reported Event|Neoadjuvant TAS 2 Months Before and During RT|Neoadjuvant Total Androgen Suppression (TAS) two months before and during radiation therapy
1263649|NCT00002558|B3|Baseline|Total|Total of all reporting groups
1263650|NCT00002558|B2|Baseline|Group B|Group B: Prior Treatment Limited to > 6 Cycles of Cisplatin
1263651|NCT00002558|B1|Baseline|Group A|Group A: Prior Treatment Limited to <= 6 Cycles of Cisplatin
1263652|NCT00002558|P2|Participant Flow|Group B|Group B: Prior Treatment Limited to > 6 Cycles of Cisplatin
1263653|NCT00002558|P1|Participant Flow|Group A|Group A: Prior Treatment Limited to <= 6 Cycles of Cisplatin
1263654|NCT00002558|O2|Outcome|Group B|Group B: Prior Treatment Limited to > 6 Cycles of Cisplatin
1263655|NCT00002558|O1|Outcome|Group A|Group A: Prior Treatment Limited to <= 6 Cycles of Cisplatin
1263656|NCT00002558|E2|Reported Event|Group: B > 6 Cycles of Cisplatin|Group B: Prior Treatment Limited to > 6 Cycles of Cisplatin
1263659|NCT00002540|B2|Baseline|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
1263660|NCT00002540|B1|Baseline|Control|Participants receive standard medical care.
1263661|NCT00002540|P2|Participant Flow|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
1263662|NCT00002540|P1|Participant Flow|Control|Participants receive standard medical care.
1263663|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
1263664|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
1263665|NCT00002540|O2|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
1263666|NCT00002540|O1|Outcome|Control|Participants receive standard medical care.
1263667|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
1263668|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
1263669|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
1263670|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
1263671|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
1263672|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
1263673|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
1263674|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
1263675|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
1263676|NCT00002540|O2|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
1263677|NCT00002540|O1|Outcome|Control|Participants receive standard medical care.
1263678|NCT00002540|O2|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
1263679|NCT00002540|O1|Outcome|Control|Participants receive standard medical care.
1263680|NCT00002540|O2|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
1263681|NCT00002540|O1|Outcome|Control|Participants receive standard medical care.
1263682|NCT00002540|O2|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
1263683|NCT00002540|O1|Outcome|Control|Participants receive standard medical care.
1263684|NCT00002540|O2|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
1263685|NCT00002540|O1|Outcome|Control|Participants receive standard medical care.
1263686|NCT00002540|E1|Reported Event|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
1263687|NCT00002525|B3|Baseline|Total|Total of all reporting groups
1263688|NCT00002525|B2|Baseline|No Perioperative 5-FU|"Patients receive no perioperative fluorouracil.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
1263820|NCT00001723|O2|Outcome|Placebo|"Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program~Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
1263883|NCT00001596|E2|Reported Event|Placebo|Subjects received placebo (3 pills), three times daily.
1263689|NCT00002525|B1|Baseline|Perioperative 5-FU|"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
1263690|NCT00002525|P2|Participant Flow|No Perioperative 5-FU|"Patients receive no perioperative fluorouracil.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5 fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5 leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
1263691|NCT00002525|P1|Participant Flow|Perioperative 5-FU|"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
1263692|NCT00002525|O2|Outcome|No Perioperative 5-FU|"Patients receive no perioperative fluorouracil.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
1263693|NCT00002525|O1|Outcome|Perioperative 5-FU|"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
1263694|NCT00002525|O2|Outcome|No Perioperative 5-FU|"Patients receive no perioperative fluorouracil.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
1263695|NCT00002525|O1|Outcome|Perioperative 5-FU|"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
1263696|NCT00002525|O2|Outcome|No Perioperative 5-FU|"Patients receive no perioperative fluorouracil.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
1263697|NCT00002525|O1|Outcome|Perioperative 5-FU|"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
1263698|NCT00002525|O2|Outcome|No Perioperative 5-FU|"Patients receive no perioperative fluorouracil.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
1263699|NCT00002525|O1|Outcome|Perioperative 5-FU|"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
1263700|NCT00002525|E4|Reported Event|Adjuvant Chemotherapy-- 5-FU+Leucovovin|"After surgery, patients with stage IIC or III disease enrolled between August 1993 and August 1997 receive the following adjuvant chemotherapy:~Levamisole: 50 mg PO TID Days 1-3 and Days 15-17; 50 mg PO TID x 3 days beginning Day 29, repeat every 14 days for 11 months.~5-FU: 450 mg/m²/day IV bolus for Days 1-5. 450 mg/m² IV bolus once weekly beginning Day 29, repeat weekly for a maximum of 11 months.~All patients with Dukes' B3/C disease for who adverse vents were collected were included in the analysis."
1263701|NCT00002525|E3|Reported Event|Adjuvant Chemotherapy-- 5-FU+Levamisolem|"Beginning 21-35 days after surgery, patients with stage IIC or III disease enrolled between September 1997 and May 2000 receive the following adjuvant chemotherapy:~Leucovorin: 20 mg/m² IV push days 1-5 5-FU: 425 mg/m² IV push days 1-5, give immediately after Leucovorin~A cycle of therapy consisted of 5 consecutive days of chemotherapy. Cycles were repeated at the end of 4 weeks (day 29), 8 weeks (day 57) and then every 4 weeks for a total of 6 cycles.~All patients with Dukes' B3/C disease for who adverse vents were collected were included in the analysis."
1263875|NCT00001596|O2|Outcome|Placebo|Subjects received placebo (3 pills), three times daily.
1263702|NCT00002525|E2|Reported Event|Arm II (No Perioperative 5-FU)|"Patients receive no perioperative fluorouracil.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
1263703|NCT00002525|E1|Reported Event|Arm I (Perioperative 5-FU)|"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
1263704|NCT00001984|B1|Baseline|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
1263705|NCT00001984|P1|Participant Flow|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
1263706|NCT00001984|O1|Outcome|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
1263707|NCT00001984|O1|Outcome|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
1263708|NCT00001984|O1|Outcome|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
1263709|NCT00001984|O1|Outcome|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
1263710|NCT00001984|O1|Outcome|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
1263711|NCT00001984|O1|Outcome|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
1263712|NCT00001984|O1|Outcome|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
1263713|NCT00001984|E1|Reported Event|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
1263714|NCT00001962|B1|Baseline|Daclizumab Hematologic Response|daclizumab, 1 mg/kg of body weight, will be given for a total of 5 intravenous infusions. The subjects diagnosed with moderate aplastic anemia, pure red cell aplasia, Diamond Blackfan anemia, relapse and refractory severe aplastic anemia will receive treatment. The subjects will be seen and receive the daclizumab infusion biweekly during the treatment period. The Diamond Blackfan anemia arm was closed due to lack of accrual.
1263715|NCT00001962|P1|Participant Flow|Daclizumab Hematologic Response|daclizumab, 1 mg/kg of body weight, will be given for a total of 5 intravenous infusions. The subjects diagnosed with moderate aplastic anemia, pure red cell aplasia, Diamond Blackfan anemia, relapse and refractory severe aplastic anemia will receive treatment. The subjects will be seen and receive the daclizumab infusion biweekly during the treatment period.The Diamond Blackfan anemia arm was closed due to lack of accrual.
1263716|NCT00001962|O1|Outcome|Daclizumab Hematologic Response|daclizumab, 1 mg/kg of body weight, will be given for a total of 5 intravenous infusions to subjects diagnosed with moderate aplastic anemia (MAA), pure red cell aplasia (PRCA), Diamond Blackfan anemia (DBA), relapse and refractory severe aplastic anemia (SAA) will receive treatment.
1263717|NCT00001962|E1|Reported Event|Daclizumab Hematologic Response|daclizumab, 1 mg/kg of body weight, will be given for a total of 5 intravenous infusions. The subjects diagnosed with moderate aplastic anemia, pure red cell aplasia, Diamond Blackfan anemia, relapse and refractory severe aplastic anemia will receive treatment. The subjects will be seen and receive the daclizumab infusion biweekly during the treatment period. The Diamond Blackfan anemia arm was closed due to lack of accrual.
1263718|NCT00001959|B1|Baseline|Pirfenidone|During the study drug period of 12 months, patients will receive oral pirfenidone daily. For patients whose initial renal function is 50-80 ml/min as assessed by the MDRD equation, the initial pirfenidone dosage will be calculated at 40 mg/kg/d, with a maximum dose of 800 mg TID. For patients whose initial renal function is 30-50 ml/min, the initial dose will be 30 mg/kg/d. For patients whose initial renal function is between 15 and 30 ml/min, the initial dose will be 20 mg/kg/d.
1263719|NCT00001959|P1|Participant Flow|Pirfenidone|During the study drug period of 12 months, patients will receive oral pirfenidone daily. For patients whose initial renal function is 50-80 ml/min as assessed by the MDRD equation, the initial pirfenidone dosage will be calculated at 40 mg/kg/d, with a maximum dose of 800 mg TID. For patients whose initial renal function is 30-50 ml/min, the initial dose will be 30 mg/kg/d. For patients whose initial renal function is between 15 and 30 ml/min, the initial dose will be 20 mg/kg/d.
1263720|NCT00001959|O1|Outcome|Pirfenidone|During the study drug period of 12 months, patients will receive oral pirfenidone daily. For patients whose initial renal function is 50-80 ml/min as assessed by the MDRD equation, the initial pirfenidone dosage will be calculated at 40 mg/kg/d, with a maximum dose of 800 mg TID. For patients whose initial renal function is 30-50 ml/min, the initial dose will be 30 mg/kg/d. For patients whose initial renal function is between 15 and 30 ml/min, the initial dose will be 20 mg/kg/d.
1263721|NCT00001959|O1|Outcome|Pirfenidone|During the study drug period of 12 months, patients will receive oral pirfenidone daily. For patients whose initial renal function is 50-80 ml/min as assessed by the MDRD equation, the initial pirfenidone dosage will be calculated at 40 mg/kg/d, with a maximum dose of 800 mg TID. For patients whose initial renal function is 30-50 ml/min, the initial dose will be 30 mg/kg/d. For patients whose initial renal function is between 15 and 30 ml/min, the initial dose will be 20 mg/kg/d.
1263876|NCT00001596|O1|Outcome|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
1263722|NCT00001959|O1|Outcome|Pirfenidone|During the study drug period of 12 months, patients will receive oral pirfenidone daily. For patients whose initial renal function is 50-80 ml/min as assessed by the MDRD equation, the initial pirfenidone dosage will be calculated at 40 mg/kg/d, with a maximum dose of 800 mg TID. For patients whose initial renal function is 30-50 ml/min, the initial dose will be 30 mg/kg/d. For patients whose initial renal function is between 15 and 30 ml/min, the initial dose will be 20 mg/kg/d.
1263723|NCT00001959|E1|Reported Event|Pirfenidone|During the study drug period of 12 months, patients will receive oral pirfenidone daily. For patients whose initial renal function is 50-80 ml/min as assessed by the MDRD equation, the initial pirfenidone dosage will be calculated at 40 mg/kg/d, with a maximum dose of 800 mg TID. For patients whose initial renal function is 30-50 ml/min, the initial dose will be 30 mg/kg/d. For patients whose initial renal function is between 15 and 30 ml/min, the initial dose will be 20 mg/kg/d.
1263724|NCT00001941|B1|Baseline|Phase I & II Cohorts (2-8 mg/kg)|Phase I - 2 mg/kg cohort 2 mg/kg daclizumab over 60 minutes intravenously on days 1 and 2 Phase I - 4 mg/kg cohort 4 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase I - 6 mg/kg cohort 6 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase I - 8 mg/kg cohort 8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase II- 8 mg/kg cohort 8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
1263725|NCT00001941|P5|Participant Flow|Phase II- 8 mg/kg Cohort|8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
1263726|NCT00001941|P4|Participant Flow|Phase I - 8 mg/kg Cohort|8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
1263727|NCT00001941|P3|Participant Flow|Phase I - 6 mg/kg Cohort|6 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
1263728|NCT00001941|P2|Participant Flow|Phase I - 4 mg/kg Cohort|4 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
1263729|NCT00001941|P1|Participant Flow|Phase I - 2 mg/kg Cohort|2 mg/kg daclizumab over 60 minutes intravenously on days 1 and 2
1263730|NCT00001941|O1|Outcome|Phase I & II Cohorts (2-8 mg/kg)|Phase I - 2 mg/kg cohort 2 mg/kg daclizumab over 60 minutes intravenously on days 1 and 2 Phase I - 4 mg/kg cohort 4 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase I - 6 mg/kg cohort 6 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase I - 8 mg/kg cohort 8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase II- 8 mg/kg cohort 8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
1263731|NCT00001941|O1|Outcome|Phase II- 8 mg/kg Cohort|8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
1263732|NCT00001941|O1|Outcome|Phase II- 8 mg/kg Cohort|8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
1263733|NCT00001941|O1|Outcome|Phase II- 8 mg/kg Cohort|8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
1263734|NCT00001941|E1|Reported Event|Phase II- 8 mg/kg Cohort|8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
1263735|NCT00001832|B15|Baseline|Total|Total of all reporting groups
1263736|NCT00001832|B14|Baseline|Cells IV + SQ IL-2 w/GCSF (no Reactivity)|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF in patients with no reactivity
1263737|NCT00001832|B13|Baseline|Cells IV + SQ IL-2 w/GCSF (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
1263738|NCT00001832|B12|Baseline|Cells IV + SQ IL-2 w/GCSF|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF (to shorten time to neutrophil recovery), reactivity not specified
1263739|NCT00001832|B11|Baseline|Cells IV + MTD IL-2 no GCSF (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
1263740|NCT00001832|B10|Baseline|Cells IV + MTD IL-2 no GCSF (gp100 Reactive)|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
1263741|NCT00001832|B9|Baseline|Cells IV + MTD IL-2 no GCSF|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
1263742|NCT00001832|B8|Baseline|Cells IA + MTD IL-2 (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IA + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
1263743|NCT00001832|B7|Baseline|Cells IA + MTD IL-2|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IA + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) + G-CSF
1263744|NCT00001832|B6|Baseline|Cells IA + MTD IL-2 (Prior Cells IV on 6)|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IA + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + G-CSF
1263745|NCT00001832|B5|Baseline|Cells IV + MTD IL-2|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) + G-CSF (to shorten time to neutrophil recovery)
1263746|NCT00001832|B4|Baseline|Cells IV + High-Dose IV IL-2 (Initial)|Phase 1 IL-2 Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
1263747|NCT00001832|B3|Baseline|Cells IV + Low-Dose IV IL-2 (Initial)|Phase 1 IL-2 Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
1263748|NCT00001832|B2|Baseline|Cells IV + Cyclophosphamide 60mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV
1263749|NCT00001832|B1|Baseline|Cells IV + Cyclophosphamide 30mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x30mg/kg + Cells IV
1263750|NCT00001832|P15|Participant Flow|Abl Cells IV + SQ IL-2 With GCSF (no Reactivity)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 ( IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) in patients with no reactivity
1263751|NCT00001832|P14|Participant Flow|Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive)|Abl Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) with growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1) reactive) Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
1263752|NCT00001832|P13|Participant Flow|Abl Cells IV + SQ IL-2 With GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery), reactivity not specified
1263753|NCT00001832|P12|Participant Flow|Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive)|Abl Cells intravenous (IV)+ maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1)reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
1263754|NCT00001832|P11|Participant Flow|Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive)|Abl Cells intravenous (IV) + maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF)(gp100 reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
1263755|NCT00001832|P10|Participant Flow|Abl Cells IV + MTD IL-2 no GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without growth colony stimulating factor (G-CSF) (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
1263756|NCT00001832|P9|Participant Flow|Abl Cells IA+MTD IL-2 (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) + melanoma- associated antigen recognized by T cells (MART-1):26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
1263757|NCT00001832|P8|Participant Flow|Abl Cells IA + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF)
1263758|NCT00001832|P7|Participant Flow|Abl Cells IA + MTD (Prior Cells IV on 6)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + growth colony stimulating factor (G-CSF)
1263759|NCT00001832|P6|Participant Flow|Abl Cells IV + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery)
1263760|NCT00001832|P5|Participant Flow|Abl Cells IV+High Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
1263761|NCT00001832|P4|Participant Flow|Abl Cells IV+Low Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
1263762|NCT00001832|P3|Participant Flow|Abl Cells IV + Cyclophosphamide 60 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV)
1263763|NCT00001832|P2|Participant Flow|Abl Cells IV + Cyclophosphamide 30 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x30mg/kg + Cells intravenous (IV)
1263764|NCT00001832|P1|Participant Flow|Abl Cells in Culture|Peripheral blood mononuclear cells (PBMC) and/or tumor infiltrating lymphocytes (TIL) obtained by apheresis or lesion excision to be cloned and expanded in the lab. All patients were enrolled on Arm 0 and their cells were then sent to the lab. If the lab was able to manufacture the cell product then the patient was enrolled on one of the treatment arms.
1263765|NCT00001832|O14|Outcome|Abl Cells IV + SQ IL-2 With GCSF (no Reactivity)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 ( IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) in patients with no reactivity
1263766|NCT00001832|O13|Outcome|Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive)|Abl Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) with growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1) reactive) Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
1263767|NCT00001832|O12|Outcome|Abl Cells IV + SQ IL-2 With GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery), reactivity not specified
1263768|NCT00001832|O11|Outcome|Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive)|Abl Cells intravenous (IV)+ maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1)reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
1263769|NCT00001832|O10|Outcome|Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive)|Abl Cells intravenous (IV) + maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF)(gp100 reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
1263770|NCT00001832|O9|Outcome|Abl Cells IV + MTD IL-2 no GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without growth colony stimulating factor (G-CSF) (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
1263771|NCT00001832|O8|Outcome|Abl Cells IA+MTD IL-2 (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) + melanoma- associated antigen recognized by T cells (MART-1):26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
1263772|NCT00001832|O7|Outcome|Abl Cells IA + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF)
1263773|NCT00001832|O6|Outcome|Abl Cells IA + MTD (Prior Cells IV on 6)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + growth colony stimulating factor (G-CSF)
1263774|NCT00001832|O5|Outcome|Abl Cells IV + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery)
1263775|NCT00001832|O4|Outcome|Abl Cells IV+High Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
1263776|NCT00001832|O3|Outcome|Abl Cells IV+Low Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
1263777|NCT00001832|O2|Outcome|Abl Cells IV + Cyclophosphamide 60 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV)
1263778|NCT00001832|O1|Outcome|Abl Cells IV + Cyclophosphamide 30 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x30mg/kg + Cells intravenous (IV)
1263779|NCT00001832|O14|Outcome|Abl Cells IV + SQ IL-2 With GCSF (no Reactivity)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 ( IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) in patients with no reactivity
1263780|NCT00001832|O13|Outcome|Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive)|Abl Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) with growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1) reactive) Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
1263781|NCT00001832|O12|Outcome|Abl Cells IV + SQ IL-2 With GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery), reactivity not specified
1263782|NCT00001832|O11|Outcome|Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive)|Abl Cells intravenous (IV)+ maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1)reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
1263783|NCT00001832|O10|Outcome|Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive)|Abl Cells intravenous (IV) + maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF)(gp100 reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
1263784|NCT00001832|O9|Outcome|Abl Cells IV + MTD IL-2 no GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without growth colony stimulating factor (G-CSF) (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
1263785|NCT00001832|O8|Outcome|Abl Cells IA+MTD IL-2 (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) + melanoma- associated antigen recognized by T cells (MART-1):26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
1263786|NCT00001832|O7|Outcome|Abl Cells IA + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF)
1263787|NCT00001832|O6|Outcome|Abl Cells IA + MTD (Prior Cells IV on 6)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + growth colony stimulating factor (G-CSF)
1263788|NCT00001832|O5|Outcome|Abl Cells IV + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery)
1263789|NCT00001832|O4|Outcome|Abl Cells IV+High Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
1263790|NCT00001832|O3|Outcome|Abl Cells IV+Low Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
1263791|NCT00001832|O2|Outcome|Abl Cells IV + Cyclophosphamide 60 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV)
1263792|NCT00001832|O1|Outcome|Abl Cells IV + Cyclophosphamide 30 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x30mg/kg + Cells intravenous (IV)
1263793|NCT00001832|E14|Reported Event|Abl Cells IV + SQ IL-2 With GCSF (no Reactivity)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 ( IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) in patients with no reactivity
1263877|NCT00001596|O2|Outcome|Placebo|Subjects received placebo (3 pills), three times daily.
1263794|NCT00001832|E13|Reported Event|Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive)|Abl Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) with granulocyte colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1) reactive) Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
1263795|NCT00001832|E12|Reported Event|Abl Cells IV + SQ IL-2 With GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + granulocyte colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery), reactivity not specified
1263796|NCT00001832|E11|Reported Event|Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive)|Abl Cells intravenous (IV)+ maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1)reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
1263797|NCT00001832|E10|Reported Event|Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive)|Abl Cells intravenous (IV) + maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF)(gp100 reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
1263798|NCT00001832|E9|Reported Event|Abl Cells IV + MTD IL-2 no GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without growth colony stimulating factor (G-CSF) (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
1263799|NCT00001832|E8|Reported Event|Abl Cells IA+MTD IL-2 (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) + melanoma- associated antigen recognized by T cells (MART-1):26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
1263800|NCT00001832|E7|Reported Event|Abl Cells IA + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF)
1263801|NCT00001832|E6|Reported Event|Abl Cells IA + MTD (Prior Cells IV on 6)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + growth colony stimulating factor (G-CSF)
1263802|NCT00001832|E5|Reported Event|Abl Cells IV + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery)
1263803|NCT00001832|E4|Reported Event|Abl Cells IV+High Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
1263804|NCT00001832|E3|Reported Event|Abl Cells IV+Low Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
1263805|NCT00001832|E2|Reported Event|Abl Cells IV + Cyclophosphamide 60 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV)
1263806|NCT00001832|E1|Reported Event|Abl Cells IV + Cyclophosphamide 30 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x30mg/kg + Cells intravenous (IV)
1263807|NCT00001723|B3|Baseline|Total|Total of all reporting groups
1263808|NCT00001723|B2|Baseline|Placebo|"Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program~Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
1263809|NCT00001723|B1|Baseline|Orlistat|"Orlistat 120 mg TID for 6 months plus a behavioral weight loss program~Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
1263810|NCT00001723|P2|Participant Flow|Placebo|"Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program~Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
1263811|NCT00001723|P1|Participant Flow|Orlistat|"Orlistat 120 mg TID for 6 months plus a behavioral weight loss program~Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
1263812|NCT00001723|O4|Outcome|Placebo - Non-Hispanic Whites|Change in weight for Non-Hispanic White participants treated with placebo
1263813|NCT00001723|O3|Outcome|Placebo - Non-Hispanic Blacks|Change in weight for Non-Hispanic Black participants treated with placebo
1263814|NCT00001723|O2|Outcome|Orlistat - Non- Hispanic Whites|Change in weight for Non-Hispanic White participants treated with orlistat
1263815|NCT00001723|O1|Outcome|Orlistat - Non-Hispanic Blacks|Change in weight for Non-Hispanic Black participants treated with orlistat
1263816|NCT00001723|O2|Outcome|Placebo|"Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program~Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
1263817|NCT00001723|O1|Outcome|Orlistat|"Orlistat 120 mg TID for 6 months plus a behavioral weight loss program~Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
1263818|NCT00001723|O2|Outcome|Placebo|"Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program~Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
1263819|NCT00001723|O1|Outcome|Orlistat|"Orlistat 120 mg TID for 6 months plus a behavioral weight loss program~Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
1263821|NCT00001723|O1|Outcome|Orlistat|"Orlistat 120 mg TID for 6 months plus a behavioral weight loss program~Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
1263822|NCT00001723|O2|Outcome|Placebo|"Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program~Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
1263823|NCT00001723|O1|Outcome|Orlistat|"Orlistat 120 mg TID for 6 months plus a behavioral weight loss program~Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
1263824|NCT00001723|E2|Reported Event|Placebo|Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months.
1263825|NCT00001723|E1|Reported Event|Orlistat|Orlistat 120 mg TID for 6 months plus a behavioral weight loss program Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months.
1263826|NCT00001703|B1|Baseline|Group A-VHL Peptide and ISA-51 Adjuvant|Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
1263827|NCT00001703|P1|Participant Flow|Group A-VHL Peptide and ISA-51 Adjuvant|Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
1263828|NCT00001703|O1|Outcome|Group A-VHL Peptide and ISA-51 Adjuvant|Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
1263829|NCT00001703|O1|Outcome|Group A-VHL Peptide and ISA-51 Adjuvant|Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
1263830|NCT00001703|E1|Reported Event|Group A-VHL Peptide and ISA-51 Adjuvant|Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
1263831|NCT00001656|B3|Baseline|Total|Total of all reporting groups
1263832|NCT00001656|B2|Baseline|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
1263833|NCT00001656|B1|Baseline|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
1263834|NCT00001656|P2|Participant Flow|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
1263835|NCT00001656|P1|Participant Flow|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
1263836|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
1263837|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
1263838|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
1263839|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
1263840|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
1263841|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
1263842|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
1263843|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
1263844|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
1263845|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
1263846|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
1263847|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
1263848|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
1263849|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
1263850|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
1263851|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
1263878|NCT00001596|O1|Outcome|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
1263879|NCT00001596|O2|Outcome|Placebo|Subjects received placebo (3 pills), three times daily.
1263880|NCT00001596|O1|Outcome|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
1263852|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
1263853|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
1263854|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
1263855|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
1263856|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
1263857|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
1263858|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
1263859|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
1263860|NCT00001656|E2|Reported Event|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
1263861|NCT00001656|E1|Reported Event|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
1263862|NCT00001596|B3|Baseline|Total|Total of all reporting groups
1263863|NCT00001596|B2|Baseline|Placebo|Subjects received placebo (3 pills), three times daily.
1263864|NCT00001596|B1|Baseline|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
1263865|NCT00001596|P2|Participant Flow|Placebo|Subjects received placebo (3 pills), three times daily.
1263866|NCT00001596|P1|Participant Flow|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
1263867|NCT00001596|O2|Outcome|Placebo|Subjects received placebo (3 pills), three times daily.
1263868|NCT00001596|O1|Outcome|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
1263869|NCT00001596|O2|Outcome|Placebo|Subjects received placebo (3 pills), three times daily.
1263870|NCT00001596|O1|Outcome|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
1263871|NCT00001596|O2|Outcome|Placebo|Subjects received placebo (3 pills), three times daily.
1263872|NCT00001596|O1|Outcome|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
1263873|NCT00001596|O2|Outcome|Placebo|Subjects received placebo (3 pills), three times daily.
1263874|NCT00001596|O1|Outcome|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
1263884|NCT00001596|E1|Reported Event|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
1263885|NCT00001586|B3|Baseline|Total|Total of all reporting groups
1263886|NCT00001586|B2|Baseline|Low-Intermediate Risk B-Cell Pts|Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered.
1263887|NCT00001586|B1|Baseline|Intermediate-high Risk B-Cell Pts|Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days.
1263888|NCT00001586|P2|Participant Flow|Low-Intermediate Risk B-Cell Pts|Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered. Eligible to donate cells.
1263889|NCT00001586|P1|Participant Flow|Intermediate-high Risk B-Cell Pts|Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days.
1263890|NCT00001586|O2|Outcome|Low-Intermediate Risk B-Cell Pts|Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered.
1263891|NCT00001586|O1|Outcome|Intermediate-high Risk B-Cell Pts|Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days.
1263892|NCT00001586|O2|Outcome|Low-Intermediate Risk B-Cell Pts|Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered.
1263893|NCT00001586|O1|Outcome|Intermediate-high Risk B-Cell Pts|Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days.
1263894|NCT00001586|E2|Reported Event|Low-Intermediate Risk B-Cell Pts|Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered.
1263895|NCT00001586|E1|Reported Event|Intermediate-high Risk B-Cell Pts|Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days.
1263896|NCT00001575|B1|Baseline|Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)|"10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).~Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body"
1263897|NCT00001575|P1|Participant Flow|Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)|"10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).~Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body"
1263898|NCT00001575|O1|Outcome|Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)|"10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).~Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body"
1263899|NCT00001575|O1|Outcome|Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)|"10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).~Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body"
1263900|NCT00001575|O1|Outcome|Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)|"10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).~Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body"
1263901|NCT00001575|E1|Reported Event|Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)|"10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).~Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body"
1263902|NCT00001566|B1|Baseline|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
1263903|NCT00001566|P1|Participant Flow|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
1263904|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
1263943|NCT00001262|O2|Outcome|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
1263944|NCT00001262|O1|Outcome|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
1263905|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
1263906|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
1263907|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
1263908|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
1263909|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
1263910|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
1263911|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
1263912|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
1263913|NCT00001566|E1|Reported Event|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
1263914|NCT00001304|B3|Baseline|Total|Total of all reporting groups
1263915|NCT00001304|B2|Baseline|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
1263916|NCT00001304|B1|Baseline|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
1263917|NCT00001304|P2|Participant Flow|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
1263918|NCT00001304|P1|Participant Flow|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
1263919|NCT00001304|O2|Outcome|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
1263920|NCT00001304|O1|Outcome|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
1263921|NCT00001304|O2|Outcome|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
1263922|NCT00001304|O1|Outcome|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
1263923|NCT00001304|O2|Outcome|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
1263924|NCT00001304|O1|Outcome|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
1263925|NCT00001304|O2|Outcome|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
1263926|NCT00001304|O1|Outcome|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
1263927|NCT00001304|O2|Outcome|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
1263928|NCT00001304|O1|Outcome|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
1263929|NCT00001304|O2|Outcome|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
1263930|NCT00001304|O1|Outcome|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
1263931|NCT00001304|O2|Outcome|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
1263932|NCT00001304|O1|Outcome|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
1263933|NCT00001304|E2|Reported Event|Calcitriol & Calcium|"All patients received twice daily Calcitriol and Calcium 1000mg divided into four doses daily.~Calcitriol & Calcium"
1263934|NCT00001304|E1|Reported Event|PTH 1-34|"All patients received twice daily synthetic Human Parathyroid Hormone 1-34.~PTH 1-34"
1263935|NCT00001262|B4|Baseline|Total|Total of all reporting groups
1263936|NCT00001262|B3|Baseline|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
1263937|NCT00001262|B2|Baseline|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
1263938|NCT00001262|B1|Baseline|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
1263939|NCT00001262|P3|Participant Flow|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
1263940|NCT00001262|P2|Participant Flow|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
1263941|NCT00001262|P1|Participant Flow|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
1263942|NCT00001262|O3|Outcome|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
1263945|NCT00001262|O3|Outcome|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
1263946|NCT00001262|O2|Outcome|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
1263947|NCT00001262|O1|Outcome|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
1263948|NCT00001262|O3|Outcome|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
1263949|NCT00001262|O2|Outcome|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
1263950|NCT00001262|O1|Outcome|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
1263951|NCT00001262|O3|Outcome|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
1263952|NCT00001262|O2|Outcome|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
1263953|NCT00001262|O1|Outcome|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
1263954|NCT00001262|O3|Outcome|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
1263955|NCT00001262|O2|Outcome|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
1263956|NCT00001262|O1|Outcome|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
1263957|NCT00001262|O3|Outcome|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
1263958|NCT00001262|O2|Outcome|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
1263959|NCT00001262|O1|Outcome|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
1263960|NCT00001262|O3|Outcome|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
1263961|NCT00001262|O2|Outcome|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
1263962|NCT00001262|O1|Outcome|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
1263963|NCT00001262|E3|Reported Event|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
1263964|NCT00001262|E2|Reported Event|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
1263965|NCT00001262|E1|Reported Event|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
1263966|NCT00001213|B1|Baseline|Cysteamine Topical Solution|"Cysteamine topical solution administered hourly while awake in both eyes~Cysteamine"
1263967|NCT00001213|P1|Participant Flow|Cysteamine Topical Solution|"Cysteamine topical solution administered hourly while awake in both eyes~Cysteamine"
1263968|NCT00001213|O1|Outcome|Cysteamine Topical Solution|"Cysteamine topical solution administered hourly while awake in both eyes~Cysteamine"
1263969|NCT00001213|O1|Outcome|Cysteamine Topical Solution|"Cysteamine topical solution administered hourly while awake in both eyes~Cysteamine"
1263970|NCT00001213|E1|Reported Event|Cysteamine Topical Solution|"Cysteamine topical solution administered hourly while awake in both eyes~Cysteamine"
1263971|NCT00001151|B1|Baseline|Group 1|Patient has rickets (cild) or osteomalacia (adult) of bone
1263972|NCT00001151|P1|Participant Flow|Group 1|Patient has rickets (child) or osteomalacia (adult) of bone
1263973|NCT00001151|O1|Outcome|Group 1|Patient has rickets (cild) or osteomalacia (adult) of bone
1263974|NCT00001151|E1|Reported Event|Group 1|Patient has rickets (cild) or osteomalacia (adult) of bone
1263975|NCT00000620|B3|Baseline|Total|Total of all reporting groups
1263976|NCT00000620|B2|Baseline|Glycemia Trial: Standard Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
1263977|NCT00000620|B1|Baseline|Glycemia Trial: Intensive Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
1263978|NCT00000620|P8|Participant Flow|Glycemia Trial: Standard Control/Lipid Trial: Placebo|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.~Double blind administration of placebo matching either 160 mg/day in participants with eGFR ≥50 mL/min/1.73m2 or 54 mg/day in participants with eGFR <50 mL/min/1.73m^2 in combination with open label simvastatin. Blinded fenofibrate or placebo plus simvastatin includes double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day."
1263979|NCT00000620|P7|Participant Flow|Glycemia Trial: Standard Control/Lipid Trial: Fenofibrate|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.~Lipid Trial - Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 in combination with open label simvastatin. Blinded fenofibrate or placebo plus simvastatin includes double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day."
1264029|NCT00000575|E2|Reported Event|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
1263980|NCT00000620|P6|Participant Flow|Glycemia Trial: Standard Control/BP Trial: Standard Control|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.~BP Trial - Open label administration of multiple anti-hypertensive agents to maintain SBP level <140 mm Hg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals (intensive control <120 mm Hg; standard control <140 mm Hg)."
1263981|NCT00000620|P5|Participant Flow|Glycemia Trial: Standard Control/BP Trial: Intensive Control|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.~BP Trial - Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to <120 mmHg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals."
1263982|NCT00000620|P4|Participant Flow|Glycemia Trial: Intensive Control/Lipid Trial: Placebo|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.~Double blind administration of placebo matching either 160 mg/day in participants with eGFR ≥50 mL/min/1.73m2 or 54 mg/day in participants with eGFR <50 mL/min/1.73m^2 in combination with open label simvastatin. Blinded fenofibrate or placebo plus simvastatin includes double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day."
1263983|NCT00000620|P3|Participant Flow|Glycemia Trial: Intensive Control/Lipid Trial: Fenofibrate|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.~Lipid Trial - Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 in combination with open label simvastatin. Blinded fenofibrate or placebo plus simvastatin includes double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day."
1263984|NCT00000620|P2|Participant Flow|Glycemia Trial: Intensive Control/BP Trial: Standard Control|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.~BP Trial - Open label administration of multiple anti-hypertensive agents to maintain SBP level <140 mm Hg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals."
1263985|NCT00000620|P1|Participant Flow|Glycemia Trial: Intensive Control/BP Trial: Intensive Control|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.~BP Trial - Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to <120 mmHg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals."
1263986|NCT00000620|O2|Outcome|Lipid Trial: Placebo|Double blind administration of placebo matching either 160 mg/day in participants with eGFR ≥50 mL/min/1.73m^2 or 54 mg/day in participants with eGFR <50 mL/min/1.73m^2, in combination with open label simvastatin 20 - 40 mg/day.
1263987|NCT00000620|O1|Outcome|Lipid Trial: Fenofibrate|Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2, in combination with open label simvastatin 20 - 40 mg/day.
1263988|NCT00000620|O2|Outcome|Lipid Trial: Placebo|Double blind administration of placebo matching either 160 mg/day in participants with eGFR ≥50 mL/min/1.73m^2 or 54 mg/day in participants with eGFR <50 mL/min/1.73m^2, in combination with open label simvastatin 20 - 40 mg/day.
1263989|NCT00000620|O1|Outcome|Lipid Trial: Fenofibrate|Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2, in combination with open label simvastatin 20 - 40 mg/day.
1263990|NCT00000620|O2|Outcome|BP Trial: Standard Control|Open label administration of multiple anti-hypertensive agents to maintain SBP level to <140 mm Hg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals.
1263991|NCT00000620|O1|Outcome|BP Trial: Intensive Control|Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to <120 mmHg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals.
1263992|NCT00000620|O2|Outcome|BP Trial: Standard Control|Open label administration of multiple anti-hypertensive agents to maintain SBP level <140 mm Hg. Anti-hypertensive agents multiple anti-hypertensive agents as needed to reach Blood Pressure Trial arm-specific goals.
1263993|NCT00000620|O1|Outcome|BP Trial: Intensive Control|Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to <120 mmHg. Anti-hypertensive agents include multiple anti-hypertensive agents as needed to reach Blood Pressure Trial arm-specific goals.
1264030|NCT00000575|E1|Reported Event|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
1264031|NCT00000479|B5|Baseline|Total|Total of all reporting groups
1263994|NCT00000620|O2|Outcome|Glycemia Trial: Standard Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
1263995|NCT00000620|O1|Outcome|Glycemia Trial: Intensive Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
1263996|NCT00000620|O2|Outcome|Glycemia Trial: Standard Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
1263997|NCT00000620|O1|Outcome|Glycemia Trial: Intensive Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
1263998|NCT00000620|E2|Reported Event|Glycemia Trial: Standard Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
1263999|NCT00000620|E1|Reported Event|Glycemia Trial: Intensive Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
1264000|NCT00000575|B4|Baseline|Total|Total of all reporting groups
1264001|NCT00000575|B3|Baseline|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
1264002|NCT00000575|B2|Baseline|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
1264003|NCT00000575|B1|Baseline|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
1264004|NCT00000575|P3|Participant Flow|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
1264005|NCT00000575|P2|Participant Flow|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
1264006|NCT00000575|P1|Participant Flow|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
1264007|NCT00000575|O3|Outcome|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
1264008|NCT00000575|O2|Outcome|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
1264009|NCT00000575|O1|Outcome|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
1264010|NCT00000575|O3|Outcome|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
1264011|NCT00000575|O2|Outcome|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
1264012|NCT00000575|O1|Outcome|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
1264013|NCT00000575|O3|Outcome|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
1264014|NCT00000575|O2|Outcome|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
1264015|NCT00000575|O1|Outcome|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
1264016|NCT00000575|O3|Outcome|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
1264017|NCT00000575|O2|Outcome|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
1264018|NCT00000575|O1|Outcome|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
1264019|NCT00000575|O3|Outcome|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
1264020|NCT00000575|O2|Outcome|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
1264021|NCT00000575|O1|Outcome|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
1264022|NCT00000575|O3|Outcome|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
1264023|NCT00000575|O2|Outcome|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
1264024|NCT00000575|O1|Outcome|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
1264025|NCT00000575|O3|Outcome|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
1264026|NCT00000575|O2|Outcome|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
1264027|NCT00000575|O1|Outcome|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
1264028|NCT00000575|E3|Reported Event|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
1264033|NCT00000479|B3|Baseline|Aspirin + Vitamin E|Aspirin (100 mg every other day) and vitamin E (600 IU every other day)
1264034|NCT00000479|B2|Baseline|Vitamin E Only|Placebo aspirin and vitamin E (600 IU every other day
1264035|NCT00000479|B1|Baseline|Aspirin Only|Aspirin(100 mg every other day)and placebo vitamin E
1264036|NCT00000479|P4|Participant Flow|Both Placebos|Placebo aspirin and placebo vitamin E
1264037|NCT00000479|P3|Participant Flow|Aspirin + Vitamin E|Aspirin (100 mg every other day) and vitamin E (600 IU every other day)
1264038|NCT00000479|P2|Participant Flow|Vitamin E Only|Placebo aspirin and vitamin E (600 IU every other day
1264039|NCT00000479|P1|Participant Flow|Aspirin Only|Aspirin(100 mg every other day)and placebo vitamin E
1264040|NCT00000479|O4|Outcome|Both Placebos|Placebo aspirin and placebo vitamin E
1264041|NCT00000479|O3|Outcome|Aspirin + Vitamin E|Aspirin (100 mg every other day) and vitamin E (600 IU every other day)
1264042|NCT00000479|O2|Outcome|Vitamin E Only|Placebo aspirin and vitamin E (600 IU every other day
1264043|NCT00000479|O1|Outcome|Aspirin Only|Aspirin(100 mg every other day)and placebo vitamin E
1264044|NCT00000479|O4|Outcome|Both Placebos|Placebo aspirin and placebo vitamin E
1264045|NCT00000479|O3|Outcome|Aspirin + Vitamin E|Aspirin (100 mg every other day) and vitamin E (600 IU every other day)
1264046|NCT00000479|O2|Outcome|Vitamin E Only|Placebo aspirin and vitamin E (600 IU every other day
1264047|NCT00000479|O1|Outcome|Aspirin Only|Aspirin(100 mg every other day)and placebo vitamin E
1264048|NCT00000479|E4|Reported Event|Both Placebos|Placebo aspirin and placebo vitamin E
1264049|NCT00000479|E3|Reported Event|Aspirin + Vitamin E|Aspirin (100 mg every other day) and vitamin E (600 IU every other day)
1264050|NCT00000479|E2|Reported Event|Vitamin E Only|Placebo aspirin and vitamin E (600 IU every other day
1264051|NCT00000479|E1|Reported Event|Aspirin Only|Aspirin(100 mg every other day)and placebo vitamin E
1264052|NCT00000392|B3|Baseline|Total|Total of all reporting groups
1264053|NCT00000392|B2|Baseline|Placebo|"Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months~Placebo"
1264054|NCT00000392|B1|Baseline|Peptide T|"Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months~Peptide T"
1264055|NCT00000392|P2|Participant Flow|Placebo|"Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months~Placebo"
1264056|NCT00000392|P1|Participant Flow|Peptide T|"Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months~Peptide T"
1264057|NCT00000392|O2|Outcome|Placebo|"Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months~Placebo"
1264058|NCT00000392|O1|Outcome|Peptide T|"Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months~Peptide T"
1264059|NCT00000392|O2|Outcome|Placebo|"Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months~Placebo"
1264060|NCT00000392|O1|Outcome|Peptide T|"Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months~Peptide T"
1264061|NCT00000392|E2|Reported Event|Placebo|"Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months~Placebo"
1264062|NCT00000392|E1|Reported Event|Peptide T|"Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months~Peptide T"
1264063|NCT00000378|B3|Baseline|Total|Total of all reporting groups
1264064|NCT00000378|B2|Baseline|Nortriptyline|"patients randomized to nortriptyline dose adjusted to therapeutic level~Nortriptyline: 12 week trial dose adjusted to therapeutic level"
1264065|NCT00000378|B1|Baseline|Sertaline|"patients randomized to sertraline 12 week trial does up to 200mgs~Sertraline: 12 week trial dose up to 200mgs"
1264066|NCT00000378|P2|Participant Flow|Nortriptyline|"patients randomized to nortriptyline dose adjusted to therapeutic level~Nortriptyline: 12 week trial dose adjusted to therapeutic level"
1264067|NCT00000378|P1|Participant Flow|Sertaline|"patients randomized to sertraline 12 week trial does up to 200mgs~Sertraline: 12 week trial dose up to 200mgs"
1264068|NCT00000378|O2|Outcome|Nortriptyline|"patients randomized to nortriptyline dose adjusted to therapeutic level~Nortriptyline: 12 week trial dose adjusted to therapeutic level"
1264069|NCT00000378|O1|Outcome|Sertaline|"patients randomized to sertraline 12 week trial does up to 200mgs~Sertraline: 12 week trial dose up to 200mgs"
1264070|NCT00000378|E2|Reported Event|Nortriptyline|"patients randomized to nortriptyline dose adjusted to therapeutic level~Nortriptyline: 12 week trial dose adjusted to therapeutic level"
1264071|NCT00000378|E1|Reported Event|Sertaline|"patients randomized to sertraline 12 week trial does up to 200mgs~Sertraline: 12 week trial dose up to 200mgs"
1264072|NCT00000371|B3|Baseline|Total|Total of all reporting groups
1264073|NCT00000371|B2|Baseline|Placebo|Patients were given 50 mg of placebo daily in addition to their treatment as usual with conventional neuroleptics.
1264074|NCT00000371|B1|Baseline|D-Cycloserine|Patients were given 50 mg of D-Cycloserine daily in addition to their treatment as usual with conventional neuroleptics.
1264075|NCT00000371|P2|Participant Flow|Placebo|Patients were given 50 mg of placebo daily in addition to their treatment as usual with conventional neuroleptics.
1264076|NCT00000371|P1|Participant Flow|D-Cycloserine|Patients were given 50 mg of D-Cycloserine daily in addition to their treatment as usual with conventional neuroleptics.
1264077|NCT00000371|O2|Outcome|Placebo|Patients were given 50 mg of placebo daily in addition to their treatment as usual with conventional neuroleptics.
1264078|NCT00000371|O1|Outcome|D-Cycloserine|Patients were given 50 mg of D-Cycloserine daily in addition to their treatment as usual with conventional neuroleptics.
1264079|NCT00000371|E2|Reported Event|Placebo|Patients were given 50 mg of placebo daily in addition to their treatment as usual with conventional neuroleptics.
1264080|NCT00000371|E1|Reported Event|D-Cycloserine|Patients were given 50 mg of D-Cycloserine daily in addition to their treatment as usual with conventional neuroleptics.
1264081|NCT00000143|B3|Baseline|Total|Total of all reporting groups
1264082|NCT00000143|B2|Baseline|Cidofovir IV (Intravenous)|"cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week~Cidofovir intravenous: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week"
1264354|NCT00483327|O1|Outcome|Megestrol Acetate|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
1264810|NCT01261325|P2|Participant Flow|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
1264083|NCT00000143|B1|Baseline|Ganciclovir Implant and Oral Ganciclovir|"Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily~Ganciclovir implant and oral ganciclovir: oral ganciclovir, 1 gm three times daily"
1264084|NCT00000143|P2|Participant Flow|Cidofovir IV (Intravenous)|"cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week~Cidofovir intravenous: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week"
1264085|NCT00000143|P1|Participant Flow|Ganciclovir Implant and Oral Ganciclovir|"Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily~Ganciclovir implant and oral ganciclovir: oral ganciclovir, 1 gm three times daily"
1264086|NCT00000143|O2|Outcome|Cidofovir IV (Intravenous)|"cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week~Cidofovir intravenous: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week"
1264087|NCT00000143|O1|Outcome|Ganciclovir Implant and Oral Ganciclovir|"Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily~Ganciclovir implant and oral ganciclovir: oral ganciclovir, 1 gm three times daily"
1264088|NCT00000143|E2|Reported Event|Cidofovir IV (Intravenous)|"cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week~Cidofovir intravenous: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week"
1264089|NCT00000143|E1|Reported Event|Ganciclovir Implant and Oral Ganciclovir|"Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily~Ganciclovir implant and oral ganciclovir: oral ganciclovir, 1 gm three times daily"
1264090|NCT00000142|B4|Baseline|Total|Total of all reporting groups
1264091|NCT00000142|B3|Baseline|Cidofovir (High Dose)|"5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
1264092|NCT00000142|B2|Baseline|Cidofovir (Low Dose)|"5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
1264093|NCT00000142|B1|Baseline|Treatment Deferral|"IV (in the vein) treatment deferred until retinitis progressed, either:~5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or~5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
1264094|NCT00000142|P3|Participant Flow|Cidofovir (High Dose)|"5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
1264095|NCT00000142|P2|Participant Flow|Cidofovir (Low Dose)|"5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
1264096|NCT00000142|P1|Participant Flow|Treatment Deferral|"IV (in the vein) treatment deferred until retinitis progressed, either:~5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or~5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
1264097|NCT00000142|O3|Outcome|Cidofovir (High Dose)|"5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
1264098|NCT00000142|O2|Outcome|Cidofovir (Low Dose)|"5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
1264099|NCT00000142|O1|Outcome|Treatment Deferral|"IV (in the vein) treatment deferred until retinitis progressed, either:~5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or~5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
1264355|NCT00483327|O2|Outcome|Grade 3|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
1264100|NCT00000142|E3|Reported Event|Cidofovir (High Dose)|"5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
1264101|NCT00000142|E2|Reported Event|Cidofovir (Low Dose)|"5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
1264102|NCT00000142|E1|Reported Event|Treatment Deferral|"IV (in the vein) treatment deferred until retinitis progressed, either:~5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or~5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
1264103|NCT00000136|B3|Baseline|Total|Total of all reporting groups
1264104|NCT00000136|B2|Baseline|Ganciclovir|"The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week.~Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day~Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
1264105|NCT00000136|B1|Baseline|Foscarnet|"The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day~Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day~Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
1264106|NCT00000136|P2|Participant Flow|Ganciclovir|"The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week.~Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day~Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
1264107|NCT00000136|P1|Participant Flow|Foscarnet|"The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day~Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day~Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
1264108|NCT00000136|O2|Outcome|Ganciclovir|"The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week.~Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day~Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
1264109|NCT00000136|O1|Outcome|Foscarnet|"The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day~Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day~Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
1264110|NCT00000136|E2|Reported Event|Ganciclovir|"The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week.~Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day~Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
1264111|NCT00000136|E1|Reported Event|Foscarnet|"The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day~Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day~Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
1264112|NCT00000135|B3|Baseline|Total|Total of all reporting groups
1264113|NCT00000135|B2|Baseline|Placebo|"Placebo administered intravenous infusion every 2 weeks 60 mg.~MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
1264114|NCT00000135|B1|Baseline|MSL-109|"The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.~MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
1264115|NCT00000135|P2|Participant Flow|Placebo|"Placebo administered intravenous infusion every 2 weeks 60 mg.~MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
1264116|NCT00000135|P1|Participant Flow|MSL-109|"The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.~MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
1264117|NCT00000135|O2|Outcome|Placebo|"Placebo administered intravenous infusion every 2 weeks 60 mg.~MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
1264118|NCT00000135|O1|Outcome|MSL-109|"The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.~MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
1264119|NCT00000135|E2|Reported Event|Placebo|"Placebo administered intravenous infusion every 2 weeks 60 mg.~MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
1264120|NCT00000135|E1|Reported Event|MSL-109|"The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.~MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
1264121|NCT00000134|B4|Baseline|Total|Total of all reporting groups
1264122|NCT00000134|B3|Baseline|Combination Therapy|"combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.~Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day~Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
1264123|NCT00000134|B2|Baseline|Intravenous Ganciclovir|"intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day~Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day"
1264124|NCT00000134|B1|Baseline|Intravenous Foscarnet|"intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day~Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
1264356|NCT00483327|O1|Outcome|Grade 1 or 2|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
1264125|NCT00000134|P3|Participant Flow|Combination Therapy|"combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.~Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day~Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
1264126|NCT00000134|P2|Participant Flow|Intravenous Ganciclovir|"intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day~Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day"
1264127|NCT00000134|P1|Participant Flow|Intravenous Foscarnet|"intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day~Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
1264128|NCT00000134|O3|Outcome|Combination Therapy|"combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.~Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day~Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
1264129|NCT00000134|O2|Outcome|Intravenous Ganciclovir|"intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day~Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day"
1264130|NCT00000134|O1|Outcome|Intravenous Foscarnet|"intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day~Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
1264131|NCT00000134|E3|Reported Event|Combination Therapy|"combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.~Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day~Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
1264132|NCT00000134|E2|Reported Event|Intravenous Ganciclovir|"intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day~Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day"
1264133|NCT00000134|E1|Reported Event|Intravenous Foscarnet|"intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day~Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
1264134|NCT00000125|B3|Baseline|Total|Total of all reporting groups
1264135|NCT00000125|B2|Baseline|Treatment|Topical Antiglaucoma Agents: Topical Antiglaucoma Agents
1264136|NCT00000125|B1|Baseline|Observation|Observation only
1264137|NCT00000125|P2|Participant Flow|Treatment|Topical ocular hypotensive eye drops.
1264138|NCT00000125|P1|Participant Flow|Observation|Close Observation
1264139|NCT00000125|O2|Outcome|Treatment|Topical ocular hypotensive eye drops from February 1994 through March 2009.
1264140|NCT00000125|O1|Outcome|Observation|Observation only from February 1994 through June 2002.Observation participants were offered topical antiglaucoma agents after June 2002 through study close out March 2009.
1264141|NCT00000125|E2|Reported Event|Treatment|Topical Antiglaucoma Agents: Topical Antiglaucoma Agents from February 1994 to June 2002.
1264142|NCT00000125|E1|Reported Event|Observation|Observation only from February 1994 to June 2002 .
1264263|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264160|NCT00586170|B3|Baseline|Total|Total of all reporting groups
1264161|NCT00586170|B2|Baseline|Placebo Device + Surgery|"Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.~Placebo Device: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
1264162|NCT00586170|B1|Baseline|EBI Bone Healing System + Surgery|"Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.~EBI Bone Healing System: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
1264163|NCT00586170|P2|Participant Flow|Placebo Device + Surgery|"Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.~Placebo Device: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
1264164|NCT00586170|P1|Participant Flow|EBI Bone Healing System + Surgery|"Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.~EBI Bone Healing System: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
1264165|NCT00586170|O2|Outcome|Placebo Device + Surgery|"Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.~Placebo Device: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
1264166|NCT00586170|O1|Outcome|EBI Bone Healing System + Surgery|"Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.~EBI Bone Healing System: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
1264167|NCT00586170|O2|Outcome|Placebo Device + Surgery|"Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.~Placebo Device: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
1264168|NCT00586170|O1|Outcome|EBI Bone Healing System + Surgery|"Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.~EBI Bone Healing System: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
1264783|NCT02482428|O4|Outcome|Vehicle to LCC|Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
1264169|NCT00586170|E2|Reported Event|Placebo Device + Surgery|"Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.~Placebo Device: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
1264170|NCT00586170|E1|Reported Event|EBI Bone Healing System + Surgery|"Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.~EBI Bone Healing System: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
1264171|NCT02784925|B1|Baseline|Fatty Liver Subjects|"Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness.~Ultrasound (US) B mode image: Ultrasound (US) B mode image is an alternative method to measure tissue structure~and has proven to be an accurate technique to measure subcutaneous fat thickness."
1264172|NCT02784925|P1|Participant Flow|Fatty Liver Subjects|"Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness.~Ultrasound (US) B mode image: Ultrasound (US) B mode image is an alternative method to measure tissue structure~and has proven to be an accurate technique to measure subcutaneous fat thickness."
1264173|NCT02784925|O1|Outcome|Fatty Liver Subjects|"Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness.~Ultrasound (US) B mode image: Ultrasound (US) B mode image is an alternative method to measure tissue structure~and has proven to be an accurate technique to measure subcutaneous fat thickness."
1264174|NCT02784925|E1|Reported Event|Fatty Liver Subjects|Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness.Ultrasound (US) B mode image: Ultrasound (US) B mode image is an alternative method to measure tissue structure and has proven to be an accurate technique to measure subcutaneous fat thickness.
1264175|NCT02388191|B3|Baseline|Total|Total of all reporting groups
1264176|NCT02388191|B2|Baseline|Placebo|"Placebo~Placebo tablet"
1264177|NCT02388191|B1|Baseline|Naproxen Sodium|"550 mg naproxen sodium~Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1"
1264178|NCT02388191|P2|Participant Flow|Placebo|"Placebo~Placebo tablet"
1264179|NCT02388191|P1|Participant Flow|Naproxen Sodium|"550 mg naproxen sodium~Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1"
1264180|NCT02388191|O2|Outcome|Placebo|"Placebo~Placebo tablet"
1264181|NCT02388191|O1|Outcome|Naproxen Sodium|"550 mg naproxen sodium~Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1"
1264182|NCT02388191|O2|Outcome|Placebo|"Placebo~Placebo tablet"
1264183|NCT02388191|O1|Outcome|Naproxen Sodium|"550 mg naproxen sodium~Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1"
1264184|NCT02388191|O2|Outcome|Placebo|"Placebo~Placebo tablet"
1264185|NCT02388191|O1|Outcome|Naproxen Sodium|"550 mg naproxen sodium~Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1"
1264186|NCT02388191|O2|Outcome|Placebo|"Placebo~Placebo tablet"
1264187|NCT02388191|O1|Outcome|Naproxen Sodium|"550 mg naproxen sodium~Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1"
1264188|NCT02388191|O2|Outcome|Placebo|"Placebo~Placebo tablet"
1264189|NCT02388191|O1|Outcome|Naproxen Sodium|"550 mg naproxen sodium~Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1"
1264190|NCT02388191|E2|Reported Event|Placebo|"Placebo~Placebo tablet"
1264191|NCT02388191|E1|Reported Event|Naproxen Sodium|"550 mg naproxen sodium~Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1"
1264192|NCT02357342|B3|Baseline|Total|Total of all reporting groups
1264193|NCT02357342|B2|Baseline|Standard of Care Intravitreal antiVEGF|"antiVEGF intravitreal injections~Standard of Care intravitreal injections of antiVEGF: intravitreal injections of antiVEGF"
1264194|NCT02357342|B1|Baseline|Sirolimus|"Intravitreal Sirolimus~Sirolimus: intravitreal injection"
1264195|NCT02357342|P2|Participant Flow|Standard of Care Intravitreal Anti-VEGF|Standard of Care intravitreal injections of either bevacizumab (1.25mg/0.05ml) or aflibercept (2mg/0.05ml). Bevacizumab injections were repeated at monthly intervals and aflibercept was given at baseline, month 2 and 4 and sham injections at months 1, 3 and 5. Subjects in this group continued the same drug they were on prior to joining the study.
1264196|NCT02357342|P1|Participant Flow|Sirolimus|"Intravitreal Sirolimus~Sirolimus: intravitreal injection at baseline, month 2 and month 4. Sham injections at months 1, 3 and 5"
1264264|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264787|NCT02482428|O4|Outcome|Aldara|Aldara 5% cream 3 applications per week for a maximum of 16 weeks
1264197|NCT02357342|O2|Outcome|Standard of Care Intravitreal Anti-VEGF|Standard of Care intravitreal injections of either bevacizumab (1.25mg/0.05ml) or aflibercept (2mg/0.05ml). Bevacizumab injections were repeated at monthly intervals and aflibercept was given at baseline, month 2 and 4 and sham injections at months 1, 3 and 5. Subjects in this group continued the same drug they were on prior to joining the study.
1264198|NCT02357342|O1|Outcome|Sirolimus|"Intravitreal Sirolimus~Sirolimus: intravitreal injection at baseline, month 2 and month 4. Sham injections at months 1, 3 and 5"
1264199|NCT02357342|O2|Outcome|Standard of Care Intravitreal Anti-VEGF|Standard of Care intravitreal injections of either bevacizumab (1.25mg/0.05ml) or aflibercept (2mg/0.05ml). Bevacizumab injections were repeated at monthly intervals and aflibercept was given at baseline, month 2 and 4 and sham injections at months 1, 3 and 5. Subjects in this group continued the same drug they were on prior to joining the study.
1264200|NCT02357342|O1|Outcome|Sirolimus|"Intravitreal Sirolimus~Sirolimus: intravitreal injection at baseline, month 2 and month 4. Sham injections at months 1, 3 and 5"
1264201|NCT02357342|O2|Outcome|Standard of Care Intravitreal Anti-VEGF|Standard of Care intravitreal injections of either bevacizumab (1.25mg/0.05ml) or aflibercept (2mg/0.05ml). Bevacizumab injections were repeated at monthly intervals and aflibercept was given at baseline, month 2 and 4 and sham injections at months 1, 3 and 5. Subjects in this group continued the same drug they were on prior to joining the study.
1264202|NCT02357342|O1|Outcome|Sirolimus|"Intravitreal Sirolimus~Sirolimus: intravitreal injection at baseline, month 2 and month 4. Sham injections at months 1, 3 and 5"
1264203|NCT02357342|E2|Reported Event|Standard of Care Intravitreal Anti-VEGF|Standard of Care intravitreal injections of either bevacizumab (1.25mg/0.05ml) or aflibercept (2mg/0.05ml). Bevacizumab injections were repeated at monthly intervals and aflibercept was given at baseline, month 2 and 4 and sham injections at months 1, 3 and 5. Subjects in this group continued the same drug they were on prior to joining the study.
1264204|NCT02357342|E1|Reported Event|Sirolimus|"Intravitreal Sirolimus~Sirolimus: intravitreal injection at baseline, month 2 and month 4. Sham injections at months 1, 3 and 5"
1264205|NCT01893359|B4|Baseline|Total|Total of all reporting groups
1264206|NCT01893359|B3|Baseline|LASIK Only|"Eyes assigned to this arm will receive standard LASIK with no cross-linking.~Laser-assisted in situ keratomileusis"
1264207|NCT01893359|B2|Baseline|LASIK Followed by Cross-linking (Pulsed)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)~Laser-assisted in situ keratomileusis"
1264208|NCT01893359|B1|Baseline|LASIK Followed by Cross-linking (Continuous Wave)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 2 minutes continuous UVA.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)~Laser-assisted in situ keratomileusis"
1264209|NCT01893359|P3|Participant Flow|LASIK Only|"Eyes assigned to this arm will receive standard LASIK with no cross-linking.~Laser-assisted in situ keratomileusis"
1264210|NCT01893359|P2|Participant Flow|LASIK Followed by Cross-linking (Pulsed)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)~Laser-assisted in situ keratomileusis"
1264211|NCT01893359|P1|Participant Flow|LASIK Followed by Cross-linking (Continuous Wave)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 2 minutes continuous UVA.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)~Laser-assisted in situ keratomileusis"
1264212|NCT01893359|O3|Outcome|LASIK Only|"Eyes assigned to this arm will receive standard LASIK with no cross-linking.~Laser-assisted in situ keratomileusis"
1264213|NCT01893359|O2|Outcome|LASIK Followed by Cross-linking (Pulsed)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)~Laser-assisted in situ keratomileusis"
1264214|NCT01893359|O1|Outcome|LASIK Followed by Cross-linking (Continuous Wave)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 2 minutes continuous UVA.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)~Laser-assisted in situ keratomileusis"
1264215|NCT01893359|O3|Outcome|LASIK Only|"Eyes assigned to this arm will receive standard LASIK with no cross-linking.~Laser-assisted in situ keratomileusis"
1264216|NCT01893359|O2|Outcome|LASIK Followed by Cross-linking (Pulsed)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)~Laser-assisted in situ keratomileusis"
1264217|NCT01893359|O1|Outcome|LASIK Followed by Cross-linking (Continuous Wave)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 2 minutes continuous UVA.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)~Laser-assisted in situ keratomileusis"
1264218|NCT01893359|E3|Reported Event|LASIK Only|"Eyes assigned to this arm will receive standard LASIK with no cross-linking.~Laser-assisted in situ keratomileusis"
1264219|NCT01893359|E2|Reported Event|LASIK Followed by Cross-linking (Pulsed)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)~Laser-assisted in situ keratomileusis"
1264220|NCT01893359|E1|Reported Event|LASIK Followed by Cross-linking (Continuous Wave)|"Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 2 minutes continuous UVA.~riboflavin ophthalmic solution, 0% dextran~UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)~Laser-assisted in situ keratomileusis"
1264221|NCT01851720|B3|Baseline|Total|Total of all reporting groups
1264222|NCT01851720|B2|Baseline|Low Dose IV Fentanyl PCA|"Initially: 10 mcg demand dose every 12 minutes~No initial bolus and no continuous infusion~Demand dose increased 10 mcg every 12 minutes if necessary~Maximum dose of 100 mcg/hr~Low dose fentanyl PCA"
1264223|NCT01851720|B1|Baseline|Control Group / Standard of Care|"IV fentanyl bolus 25-50 mcg every 1-2 hrs as needed for pain~(Bolus dose can be titrated up in 25 mcg increments if necessary)~Maximum dose of 100 mcg/hr~Standard IV fentanyl bolus"
1264345|NCT00610857|B1|Baseline|Interferon Alfa-2b + Tremelimumab|Patients treated with Tremelimumab 15 mg/kg at start of C1 + IFN-2b IV 20 MU/m2/d for 5 d/wk for 4 weeks; C2 onward- IFN-2b SQ 10MU/m2/d for 3 d/wk for 4 weeks
1264224|NCT01851720|P2|Participant Flow|Low Dose IV Fentanyl Patient Controlled Analgesia (PCA)|"Initially: 10 mcg demand dose every 12 minutes~No initial bolus and no continuous infusion~Demand dose increased 10 mcg every 12 minutes if necessary~Maximum dose of 100 mcg/hr~Low dose fentanyl PCA"
1264225|NCT01851720|P1|Participant Flow|Control Group / Standard of Care|"IV fentanyl bolus 25-50 mcg every 1-2 hrs as needed for pain~(Bolus dose can be titrated up in 25 mcg increments if necessary)~Maximum dose of 100 mcg/hr~Standard IV fentanyl bolus"
1264226|NCT01851720|O2|Outcome|Low Dose IV Fentanyl PCA|"Initially: 10 mcg demand dose every 12 minutes~No initial bolus and no continuous infusion~Demand dose increased 10 mcg every 12 minutes if necessary~Maximum dose of 100 mcg/hr~Low dose fentanyl PCA"
1264227|NCT01851720|O1|Outcome|Control Group / Standard of Care|"IV fentanyl bolus 25-50 mcg every 1-2 hrs as needed for pain~(Bolus dose can be titrated up in 25 mcg increments if necessary)~Maximum dose of 100 mcg/hr~Standard IV fentanyl bolus"
1264228|NCT01851720|E2|Reported Event|Low Dose IV Fentanyl PCA|"Initially: 10 mcg demand dose every 12 minutes~No initial bolus and no continuous infusion~Demand dose increased 10 mcg every 12 minutes if necessary~Maximum dose of 100 mcg/hr~Low dose fentanyl PCA"
1264229|NCT01851720|E1|Reported Event|Control Group / Standard of Care|"IV fentanyl bolus 25-50 mcg every 1-2 hrs as needed for pain~(Bolus dose can be titrated up in 25 mcg increments if necessary)~Maximum dose of 100 mcg/hr~Standard IV fentanyl bolus"
1264230|NCT01849458|B1|Baseline|BioFiber|Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
1264231|NCT01849458|P1|Participant Flow|BioFiber Scaffold|Single arm of subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
1264232|NCT01849458|O1|Outcome|BioFiber|Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
1264233|NCT01849458|O1|Outcome|BioFiber|Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
1264234|NCT01849458|O1|Outcome|BioFiber|Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
1264235|NCT01849458|O1|Outcome|BioFiber|Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
1264236|NCT01849458|O1|Outcome|BioFiber|Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
1264237|NCT01849458|O1|Outcome|BioFiber|Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
1264238|NCT01849458|O1|Outcome|BioFiber|Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
1264239|NCT01849458|E1|Reported Event|BioFiber|Subjects implanted with BioFiber Scaffold or BioFiber-CM Scaffold
1264240|NCT01762761|B3|Baseline|Total|Total of all reporting groups
1264241|NCT01762761|B2|Baseline|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264242|NCT01762761|B1|Baseline|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264243|NCT01762761|P2|Participant Flow|Eltrombopag|Participants initially received eltrombopag 25 milligrams (mg) QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264244|NCT01762761|P1|Participant Flow|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264245|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
1264246|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
1264265|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264266|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264247|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
1264248|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
1264272|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264249|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
1264250|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
1264251|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
1264252|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
1264253|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
1264254|NCT01762761|O1|Outcome|Eltrombopag|In Stage 1, Participants were given placebo QD for 8 weeks or were initially treated with 25 mg eltrombopag. Dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks based on weekly platelet counts. In Stage 2, participants who received eltrombopag in Stage 1 continued with the same dose of eltrombopag unless the platelet count warranted an adjustment. Participants who received placebo in Stage 1 started 25 mg eltrombopag once daily as the initial dose and was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for period of 8 weeks on based on weekly platelet counts.
1264255|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264256|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264257|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264258|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264259|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264260|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264261|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264262|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264267|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264268|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264269|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264270|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264271|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264811|NCT01261325|P1|Participant Flow|Placebo|Matching placebo tablets administered twice daily
1264273|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264274|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264275|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264276|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264277|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264278|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264279|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264280|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264281|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264282|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264283|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264284|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264285|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264286|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264287|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264288|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264289|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264290|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264291|NCT01762761|O2|Outcome|Eltrombopag|Participants initially received eltrombopag 25 mg QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264292|NCT01762761|O1|Outcome|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264293|NCT01762761|E2|Reported Event|Eltrombopag|Participants initially received eltrombopag 25 milligrams (mg) QD. Based on weekly platelet counts, the dose of eltrombopag was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264294|NCT01762761|E1|Reported Event|Placebo|Participants initially received placebo QD. Based on weekly platelet counts, the dose of placebo was adjusted to maintain platelet counts between 50×10^9/L and 250×10^9/L for a period of 8 weeks.
1264295|NCT01253317|B1|Baseline|Open-label IGF-1 Treatment|"Twelve girls with MECP2 mutations participated in the 4-week multiple ascending dose (MAD) period of open-label treatment with IGF-1 (mecasermin). The MAD focused on obtaining PK data, determining cerebrospinal fluid (CSF) penetration, evaluating safety and tolerability, and estimating feasibility of automated cardiorespiratory measures as biomarkers. Mecasermin was escalated over a 4-week period, beginning with twice daily injections of 40 mcg/kg the first week, 80 mcg/kg the second week, and 120 mcg/kg during the third and fourth weeks. CSF samples were obtained prior to initiating treatment and after completing the fourth week.~10 of these subjects went on to complete the open label extension (OLE). The OLE was designed to obtain additional information on safety, tolerability, and cardiorespiratory measures after 20-weeks of treatment, as well as preliminary data on neurologic and behavioral parameters. During the 20-week OLE subjects were evaluated every 5 weeks."
1264343|NCT00956085|O1|Outcome|Memantine|Open label memantine titrated in 5mg increments weekly to target dose of 10mg po bid for up to 6 weeks. Memantine was continued to 12 weeks in those with treatment response, either previous response to ketamine (≥ 35% Y-BOCS reduction 1 week after IV ketamine) or current response to memantine (≥ 35% Y-BOCS reduction from pre– to post–6 weeks of memantine).
1264344|NCT00956085|E1|Reported Event|Memantine|Open label memantine titrated in 5mg increments weekly to target dose of 10mg po bid for up to 6 weeks. Memantine was continued to 12 weeks in those with treatment response,13 either previous response to ketamine (≥ 35% Y-BOCS reduction 1 week after IV ketamine) or current response to memantine (≥ 35% Y-BOCS reduction from pre– to post–6 weeks of memantine).
1264296|NCT01253317|P1|Participant Flow|Open-label IGF-1 Treatment|"Twelve girls with MECP2 mutations participated in the 4-week multiple ascending dose (MAD) period of open-label treatment with IGF-1 (mecasermin). The MAD focused on obtaining PK data, determining cerebrospinal fluid (CSF) penetration, evaluating safety and tolerability, and estimating feasibility of automated cardiorespiratory measures as biomarkers. Mecasermin was escalated over a 4-week period, beginning with twice daily injections of 40 mcg/kg the first week, 80 mcg/kg the second week, and 120 mcg/kg during the third and fourth weeks. CSF samples were obtained prior to initiating treatment and after completing the fourth week.~10 of these subjects went on to complete the open label extension (OLE). The OLE was designed to obtain additional information on safety, tolerability, and cardiorespiratory measures after 20-weeks of treatment, as well as preliminary data on neurologic and behavioral parameters. During the 20-week OLE subjects were evaluated every 5 weeks."
1264297|NCT01253317|O1|Outcome|20-week Open Label Extension (OLE)|10 subjects that previously participated in the MAD went on to complete the OLE and were monitored for safety of prolonged treatment (20 weeks).
1264298|NCT01253317|O1|Outcome|MAD and OLE Treatment Periods|Twelve girls with MECP2 mutations participated in the 4-week multiple ascending dose (MAD) period of open-label treatment with IGF-1 (mecasermin). The MAD focused on obtaining PK data, determining cerebrospinal fluid (CSF) penetration, and evaluating safety and tolerability of IGF-1. Ten subjects that previously participated in the MAD went on to complete the OLE and were monitoring for safety of prolonged treatment (20 weeks).
1264299|NCT01253317|O1|Outcome|Open-label IGF-1 Treatment|"Twelve girls with MECP2 mutations participated in the 4-week multiple ascending dose (MAD) period of open-label treatment with IGF-1 (mecasermin). The MAD focused on obtaining PK data, determining cerebrospinal fluid (CSF) penetration, evaluating safety and tolerability, and estimating feasibility of automated cardiorespiratory measures as biomarkers. Mecasermin was escalated over a 4-week period, beginning with twice daily injections of 40 mcg/kg the first week, 80 mcg/kg the second week, and 120 mcg/kg during the third and fourth weeks. CSF samples were obtained prior to initiating treatment and after completing the fourth week.~10 of these subjects went on to complete the open label extension (OLE). The OLE was designed to obtain additional information on safety, tolerability, and cardiorespiratory measures after 20-weeks of treatment, as well as preliminary data on neurologic and behavioral parameters. During the 20-week OLE subjects were evaluated every 5 weeks."
1264300|NCT01253317|O2|Outcome|20-week Open Label Extension (OLE)|10 subjects that previously participated in the MAD went on to complete the OLE and were monitoring for safety of prolonged treatment (20 weeks).
1264301|NCT01253317|O1|Outcome|4-week Multiple Ascending Dose (MAD)|Twelve girls with MECP2 mutations participated in the 4-week multiple ascending dose (MAD) period of open-label treatment with IGF-1 (mecasermin). The MAD focused on obtaining PK data, determining cerebrospinal fluid (CSF) penetration, and evaluating safety and tolerability of IGF-1.
1264302|NCT01253317|E1|Reported Event|Open-label IGF-1 Treatment|"Twelve girls with MECP2 mutations participated in the 4-week multiple ascending dose (MAD) period of open-label treatment with IGF-1 (mecasermin). The MAD focused on obtaining PK data, determining cerebrospinal fluid (CSF) penetration, evaluating safety and tolerability, and estimating feasibility of automated cardiorespiratory measures as biomarkers. Mecasermin was escalated over a 4-week period, beginning with twice daily injections of 40 mcg/kg the first week, 80 mcg/kg the second week, and 120 mcg/kg during the third and fourth weeks. CSF samples were obtained prior to initiating treatment and after completing the fourth week.~10 of these subjects went on to complete the open label extension (OLE). The OLE was designed to obtain additional information on safety, tolerability, and cardiorespiratory measures after 20-weeks of treatment, as well as preliminary data on neurologic and behavioral parameters. During the 20-week OLE subjects were evaluated every 5 weeks."
1264303|NCT01233687|B1|Baseline|AMG 102 + Erlotinib|
1264304|NCT01233687|P1|Participant Flow|AMG 102 + Erlotinib|
1264305|NCT01233687|O1|Outcome|AMG 102 + Erlotinib|
1264306|NCT01233687|O1|Outcome|AMG 102 + Erlotinib|
1264307|NCT01233687|O1|Outcome|AMG 102 + Erlotinib|
1264308|NCT01233687|O1|Outcome|AMG 102 + Erlotinib|
1264309|NCT01233687|O1|Outcome|AMG 102 + Erlotinib|
1264310|NCT01233687|E1|Reported Event|AMG 102 + Erlotinib|"Serious and Non-Serious Adverse Events include the events considered at least possibly, probably or definitely related to study treatment.~Non-Serious (Other) Adverse Events include those that occurred with a frequency of more than or equal to 5%."
1264352|NCT00483327|B1|Baseline|Megestrol Acetate|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
1264974|NCT01317901|E2|Reported Event|TRU-016 (20 mg/kg)|TRU-016 (20 mg/kg) + bendamustine + rituximab
1264975|NCT01317901|E1|Reported Event|TRU-016 (10 mg/kg)|TRU-016 (10 mg/kg) + bendamustine + rituximab
1264976|NCT01188681|B5|Baseline|Total|Total of all reporting groups
1264977|NCT01188681|B4|Baseline|Phase 2: Bendamustine|"Bendamustine alone (70 mg/m2)~Bendamustine: 70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
1264978|NCT01188681|B3|Baseline|Phase 2: TRU-016 and Bendamustine|"TRU-016 (20 mg/kg) and bendamustine (70 mg/m2)~TRU-016 and bendamustine: TRU-016 (20 mg/kg) weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
1264979|NCT01188681|B2|Baseline|Phase 1: 20 mg/kg TRU-016|"TRU-016 (20 mg/kg) and bendamustine (70 mg/m2)~TRU-016 and bendamustine: TRU-016 (20 mg/kg) weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
1264353|NCT00483327|P1|Participant Flow|Megestrol Acetate|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
1264341|NCT00956085|B1|Baseline|Memantine|Open label memantine titrated in 5mg increments weekly to target dose of 10mg po bid for up to 6 weeks. Memantine was continued to 12 weeks in those with treatment response,13 either previous response to ketamine (≥ 35% Y-BOCS reduction 1 week after IV ketamine) or current response to memantine (≥ 35% Y-BOCS reduction from pre– to post–6 weeks of memantine).
1264342|NCT00956085|P1|Participant Flow|Memantine|Open label memantine titrated in 5mg increments weekly to target dose of 10mg po bid for up to 6 weeks. Memantine was continued to 12 weeks in those with treatment response,13 either previous response to ketamine (≥ 35% Y-BOCS reduction 1 week after IV ketamine) or current response to memantine (≥ 35% Y-BOCS reduction from pre– to post–6 weeks of memantine).
1264812|NCT01261325|O3|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
1264346|NCT00610857|P1|Participant Flow|Interferon Alfa-2b + Tremelimumab|Patients with stage IV melanoma (cutaneous, uveal, or mucosal) and measurable disease, most who had previously received therapy
1264347|NCT00610857|O1|Outcome|Interferon Alfa-2b + Tremelimumab|Patients treated withTremelimumab 15 mg/kg at start of C1 + IFN-2b IV 20 MU/m2/d for 5 d/wk for 4 weeks; C2 onward- IFN-2b SQ 10MU/m2/d for 3 d/wk for 4 weeks
1264348|NCT00610857|O1|Outcome|Interferon Alfa-2b + Tremelimumab|Patients treated withTremelimumab 15 mg/kg at start of C1 + IFN-2b IV 20 MU/m2/d for 5 d/wk for 4 weeks; C2 onward- IFN-2b SQ 10MU/m2/d for 3 d/wk for 4 weeks
1264349|NCT00610857|O1|Outcome|Interferon Alfa-2b + Tremelimumab|Patients treated withTremelimumab 15 mg/kg at start of C1 + IFN-2b IV 20 MU/m2/d for 5 d/wk for 4 weeks; C2 onward- IFN-2b SQ 10MU/m2/d for 3 d/wk for 4 weeks
1264350|NCT00610857|O1|Outcome|Interferon Alfa-2b + Tremelimumab|Patients treated withTremelimumab 15 mg/kg at start of C1 + IFN-2b IV 20 MU/m2/d for 5 d/wk for 4 weeks; C2 onward- IFN-2b SQ 10MU/m2/d for 3 d/wk for 4 weeks
1264351|NCT00610857|E1|Reported Event|Interferon Alfa-2b + Tremelimumab (Related and Unrelated AEs)|Patients treated withTremelimumab 15 mg/kg at start of C1 + IFN-2b IV 20 MU/m2/d for 5 d/wk for 4 weeks; C2 onward- IFN-2b SQ 10MU/m2/d for 3 d/wk for 4 weeks per cycle.
1264357|NCT00483327|O1|Outcome|Megestrol Acetate|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
1264358|NCT00483327|E1|Reported Event|Megestrol Acetate|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
1264438|NCT01894230|B3|Baseline|Total|Total of all reporting groups
1264439|NCT01894230|B2|Baseline|Usual Care Only|"Genetic testing for SLCO1B1*5 allele~Reporting for SLCO1B1*5 allele at the end of study~Reporting for SLCO1B1*5 allele at the end: Usual care recommendations provided to patient and provider at randomization. Genotyping results provided at the end of study.~Genetic testing for SLCO1B1*5 allele: Blood test for SLCO1B1*5 allele"
1264440|NCT01894230|B1|Baseline|Genotype Results Plus Usual Care|"Genetic testing for SLCO1B1*5 allele~Reporting for SLCO1B1*5 allele at randomization~Reporting for SLCO1B1*5 allele at randomization: Reporting of genetic test results to patient and provider at randomization~Genetic testing for SLCO1B1*5 allele: Blood test for SLCO1B1*5 allele"
1264441|NCT01894230|P2|Participant Flow|Usual Care Only|"Genetic testing for SLCO1B1*5 allele~Reporting for SLCO1B1*5 allele at the end of study~Reporting for SLCO1B1*5 allele at the end: Usual care recommendations provided to patient and provider at randomization. Genotyping results provided at the end of study.~Genetic testing for SLCO1B1*5 allele: Blood test for SLCO1B1*5 allele"
1264442|NCT01894230|P1|Participant Flow|Genotype Results Plus Usual Care|"Genetic testing for SLCO1B1*5 allele~Reporting for SLCO1B1*5 allele at randomization~Reporting for SLCO1B1*5 allele at randomization: Reporting of genetic test results to patient and provider at randomization~Genetic testing for SLCO1B1*5 allele: Blood test for SLCO1B1*5 allele"
1264443|NCT01894230|O2|Outcome|Usual Care Only|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at the end of study
1264444|NCT01894230|O1|Outcome|Genotype Results Plus Usual Care|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at randomization
1264445|NCT01894230|O2|Outcome|Usual Care Only|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at the end of study
1264446|NCT01894230|O1|Outcome|Genotype Results Plus Usual Care|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at randomization
1264447|NCT01894230|O2|Outcome|Usual Care Only|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at the end of study
1264448|NCT01894230|O1|Outcome|Genotype Results Plus Usual Care|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at randomization
1264449|NCT01894230|O2|Outcome|Usual Care Only|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at the end of study
1264450|NCT01894230|O1|Outcome|Genotype Results Plus Usual Care|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at randomization
1264451|NCT01894230|O2|Outcome|Usual Care Only|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at the end of study
1264452|NCT01894230|O1|Outcome|Genotype Results Plus Usual Care|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at randomization
1264453|NCT01894230|O2|Outcome|Usual Care Only|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at the end of study
1264454|NCT01894230|O1|Outcome|Genotype Results Plus Usual Care|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at randomization
1264455|NCT01894230|O2|Outcome|Usual Care Only|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at the end of study
1264456|NCT01894230|O1|Outcome|Genotype Results Plus Usual Care|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at randomization
1264457|NCT01894230|O2|Outcome|Usual Care Only|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at the end of study
1264458|NCT01894230|O1|Outcome|Genotype Results Plus Usual Care|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at randomization
1264459|NCT01894230|O2|Outcome|Usual Care Only|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at the end of study
1264460|NCT01894230|O1|Outcome|Genotype Results Plus Usual Care|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at randomization
1264461|NCT01894230|O2|Outcome|Usual Care Only|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at the end of study
1264462|NCT01894230|O1|Outcome|Genotype Results Plus Usual Care|-Genetic testing for SLCO1B1*5 allele reported to patient and provider at randomization
1264463|NCT01894230|E2|Reported Event|Usual Care Only|"Genetic testing for SLCO1B1*5 allele~Reporting for SLCO1B1*5 allele at the end of study~Reporting for SLCO1B1*5 allele at the end: Usual care recommendations provided to patient and provider at randomization. Genotyping results provided at the end of study.~Genetic testing for SLCO1B1*5 allele: Blood test for SLCO1B1*5 allele"
1264464|NCT01894230|E1|Reported Event|Genotype Results Plus Usual Care|"Genetic testing for SLCO1B1*5 allele~Reporting for SLCO1B1*5 allele at randomization~Reporting for SLCO1B1*5 allele at randomization: Reporting of genetic test results to patient and provider at randomization~Genetic testing for SLCO1B1*5 allele: Blood test for SLCO1B1*5 allele"
1264511|NCT01229943|B3|Baseline|Total|Total of all reporting groups
1264724|NCT00141921|B1|Baseline|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
1264512|NCT01229943|B2|Baseline|Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15. >~> Bevacizumab: Given IV >~> Everolimus: Given PO >~> Octreotide Acetate: Given IM"
1264513|NCT01229943|B1|Baseline|Arm I (Octreotide Acetate and Everolimus)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1. > > Everolimus: Given PO >~> Octreotide Acetate: Given IM"
1264514|NCT01229943|P2|Participant Flow|Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15. >~> Bevacizumab: Given IV >~> Everolimus: Given PO >~> Octreotide Acetate: Given IM"
1264515|NCT01229943|P1|Participant Flow|Arm I (Octreotide Acetate and Everolimus)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1. > > Everolimus: Given PO >~> Octreotide Acetate: Given IM"
1264516|NCT01229943|O2|Outcome|Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15.~Bevacizumab: Given IV~Everolimus: Given PO~Octreotide Acetate: Given IM"
1264517|NCT01229943|O1|Outcome|Arm I (Octreotide Acetate and Everolimus)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1.~Everolimus: Given PO~Octreotide Acetate: Given IM"
1264518|NCT01229943|O2|Outcome|Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15.~Bevacizumab: Given IV~Everolimus: Given PO~Octreotide Acetate: Given IM"
1264519|NCT01229943|O1|Outcome|Arm I (Octreotide Acetate and Everolimus)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1.~Everolimus: Given PO~Octreotide Acetate: Given IM"
1264520|NCT01229943|O2|Outcome|Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15. >~> Bevacizumab: Given IV >~> Everolimus: Given PO >~> Octreotide Acetate: Given IM"
1264521|NCT01229943|O1|Outcome|Arm I (Octreotide Acetate and Everolimus)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1. > > Everolimus: Given PO >~> Octreotide Acetate: Given IM"
1264522|NCT01229943|E2|Reported Event|Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15.~Bevacizumab: Given IV~Everolimus: Given PO~Octreotide Acetate: Given IM"
1264523|NCT01229943|E1|Reported Event|Arm I (Octreotide Acetate and Everolimus)|"Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1.~Everolimus: Given PO~Octreotide Acetate: Given IM"
1264550|NCT01016483|B2|Baseline|Safety Run-in Part: Regimen 2|Subjects received pimasertib capsule orally twice daily (bid) doses of 60 and 75 mg continuously for a 28-day cycle and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264784|NCT02482428|O3|Outcome|Vehicle to NMC|Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
1264547|NCT01016483|B5|Baseline|Total|Total of all reporting groups
1264548|NCT01016483|B4|Baseline|Phase II: Arm 2 (Gemcitabine + Pimasertib)|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
1264549|NCT01016483|B3|Baseline|Phase II: Arm 1 (Gemcitabine + Placebo)|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo matched to pimasertib orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
1264785|NCT02482428|O2|Outcome|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
1264551|NCT01016483|B1|Baseline|Safety Run-in Part: Regimen 1|Subjects received pimasertib capsule orally once daily (qd) doses of 15, 30, 45, 68, 90, and 120 milligram (mg) on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264552|NCT01016483|P4|Participant Flow|Phase II: Arm 2 (Gemcitabine + Pimasertib)|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
1264553|NCT01016483|P3|Participant Flow|Phase II: Arm 1 (Gemcitabine + Placebo)|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo matched to pimasertib orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
1264554|NCT01016483|P2|Participant Flow|Safety Run-in Part: Regimen 2|Subjects received pimasertib capsule orally twice daily (bid) doses of 60 and 75 mg continuously for a 28-day cycle and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks) (bid continuous regimen).
1264683|NCT00390455|E2|Reported Event|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
1264813|NCT01261325|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
1264555|NCT01016483|P1|Participant Flow|Safety Run-in Part: Regimen 1|Subjects received pimasertib capsule orally once daily (qd) doses of 15, 30, 45, 68, 90, and 120 milligram (mg) on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264556|NCT01016483|O2|Outcome|Phase II: Arm 2|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
1264557|NCT01016483|O1|Outcome|Phase II: Arm 1|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
1264558|NCT01016483|O2|Outcome|Phase II: Arm 2|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
1264559|NCT01016483|O1|Outcome|Phase II: Arm 1|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
1264560|NCT01016483|O2|Outcome|Phase II: Arm 2|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
1264561|NCT01016483|O1|Outcome|Phase II: Arm 1|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
1264562|NCT01016483|O2|Outcome|Phase II: Arm 2|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
1264563|NCT01016483|O1|Outcome|Phase II: Arm 1|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
1264564|NCT01016483|O2|Outcome|Phase II: Arm 2|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
1264565|NCT01016483|O1|Outcome|Phase II: Arm 1|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
1264566|NCT01016483|O2|Outcome|Phase II: Arm 2|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
1264567|NCT01016483|O1|Outcome|Phase II: Arm 1|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
1264568|NCT01016483|O2|Outcome|Phase II: Arm 2|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
1264569|NCT01016483|O1|Outcome|Phase II: Arm 1|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
1264570|NCT01016483|O2|Outcome|Phase II: Arm 2|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
1264786|NCT02482428|O1|Outcome|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
1264571|NCT01016483|O1|Outcome|Phase II: Arm 1|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
1264572|NCT01016483|O2|Outcome|Regimen 2: 75 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
1264573|NCT01016483|O1|Outcome|Regimen 2: 60 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
1264574|NCT01016483|O2|Outcome|Regimen 2: 75 mg|Subjects received pimasertib orally twice daily (bid) continuously without a break for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 milligram per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks) then on Days 1, 8, and 15 of a 28-day cycle.
1264809|NCT01261325|P3|Participant Flow|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
1264575|NCT01016483|O1|Outcome|Regimen 2: 60 mg|Subjects received pimasertib orally twice daily (bid) continuously without a break for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 milligram per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks) then on Days 1, 8, and 15 of a 28-day cycle.
1264576|NCT01016483|O2|Outcome|Regimen 2: 75 mg|Subjects received pimasertib orally twice daily (bid) continuously without a break for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 milligram per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks) then on Days 1, 8, and 15 of a 28-day cycle.
1264577|NCT01016483|O1|Outcome|Regimen 2: 60 mg|Subjects received pimasertib orally twice daily (bid) continuously without a break for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 milligram per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks) then on Days 1, 8, and 15 of a 28-day cycle.
1264578|NCT01016483|O2|Outcome|Regimen 2: 75 mg|Subjects received pimasertib orally twice daily (bid) continuously without a break for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 milligram per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks) then on Days 1, 8, and 15 of a 28-day cycle.
1264579|NCT01016483|O1|Outcome|Regimen 2: 60 mg|Subjects received pimasertib orally twice daily (bid) continuously without a break for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 milligram per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks) then on Days 1, 8, and 15 of a 28-day cycle.
1264580|NCT01016483|O2|Outcome|Regimen 2: 75 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
1264581|NCT01016483|O1|Outcome|Regimen 2: 60 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
1264582|NCT01016483|O2|Outcome|Regimen 2: 75 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
1264583|NCT01016483|O1|Outcome|Regimen 2: 60 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
1264584|NCT01016483|O2|Outcome|Regimen 2: 75 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
1264585|NCT01016483|O1|Outcome|Regimen 2: 60 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
1264586|NCT01016483|O2|Outcome|Regimen 1: 75 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
1264587|NCT01016483|O1|Outcome|Regimen 2: 60 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
1264588|NCT01016483|O2|Outcome|Regimen 2: 75 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
1264589|NCT01016483|O1|Outcome|Regimen 2: 60 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
1264590|NCT01016483|O6|Outcome|Regimen1: 120 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264591|NCT01016483|O5|Outcome|Regimen 1: 90 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264592|NCT01016483|O4|Outcome|Regimen 1: 68 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 68 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264593|NCT01016483|O3|Outcome|Regimen 1: 45 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 45 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264594|NCT01016483|O2|Outcome|Regimen 1: 30 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 30 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264684|NCT00390455|E1|Reported Event|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
1264595|NCT01016483|O1|Outcome|Regimen 1:15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264596|NCT01016483|O6|Outcome|Regimen 1: 120 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264597|NCT01016483|O5|Outcome|Regimen 1: 90 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264598|NCT01016483|O4|Outcome|Regimen 1: 68 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 68 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264599|NCT01016483|O3|Outcome|Regimen 1: 45 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 45 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264600|NCT01016483|O2|Outcome|Regimen 1: 30 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 30 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264601|NCT01016483|O1|Outcome|Regimen 1: 15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264602|NCT01016483|O6|Outcome|Regimen 1: 120 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264603|NCT01016483|O5|Outcome|Regimen 1: 90 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264604|NCT01016483|O4|Outcome|Regimen 1: 68 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 68 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264605|NCT01016483|O3|Outcome|Regimen 1: 45 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 45 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264606|NCT01016483|O2|Outcome|Regimen 1: 30 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 30 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264607|NCT01016483|O1|Outcome|Regimen 1: 15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264608|NCT01016483|O6|Outcome|Regimen 1: 120 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264609|NCT01016483|O5|Outcome|Regimen 1: 90 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264610|NCT01016483|O4|Outcome|Regimen 1: 68 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 68 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264675|NCT00390455|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
1264611|NCT01016483|O3|Outcome|Regimen 1: 45 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 45 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264612|NCT01016483|O2|Outcome|Regimen 1: 30 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 30 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264613|NCT01016483|O1|Outcome|Regimen 1: 15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264614|NCT01016483|O6|Outcome|Regimen 1: 120 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264615|NCT01016483|O5|Outcome|Regimen 1: 90 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264616|NCT01016483|O4|Outcome|Regimen 1: 68 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 68 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264617|NCT01016483|O3|Outcome|Regimen 1: 45 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 45 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264618|NCT01016483|O2|Outcome|Regimen 1: 30 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 30 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264619|NCT01016483|O1|Outcome|Regimen 1:15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264620|NCT01016483|O6|Outcome|Regimen1: 120 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264621|NCT01016483|O5|Outcome|Regimen 1: 90 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264622|NCT01016483|O4|Outcome|Regimen 1: 68 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 68 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264623|NCT01016483|O3|Outcome|Regimen 1: 45 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 45 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264624|NCT01016483|O2|Outcome|Regimen 1: 30 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 30 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264625|NCT01016483|O1|Outcome|Regimen 1:15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264626|NCT01016483|O6|Outcome|Regimen 1: 120 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264627|NCT01016483|O5|Outcome|Regimen 1: 90 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264628|NCT01016483|O4|Outcome|Regimen 1: 68 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 68 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264629|NCT01016483|O3|Outcome|Regimen 1: 45 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 45 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264676|NCT00390455|O1|Outcome|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
1264630|NCT01016483|O2|Outcome|Regimen 1: 30 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 30 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264631|NCT01016483|O1|Outcome|Regimen 1: 15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264632|NCT01016483|O6|Outcome|Regimen 1: 120 mg|Subjects received pimasertib orally once daily (qd) 5-days-on / 2-days-off, continuously (Days 1 to 5, 8 to 12, 15 to 19, 22 to 26, and so on) dose of 120 mg and gemcitabine 1000 milligram per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks) then on Days 1, 8, and 15 of a 28-day cycle.
1264633|NCT01016483|O5|Outcome|Regimen 1: 90 mg|Subjects received pimasertib orally once daily (qd) 5-days-on / 2-days-off, continuously (Days 1 to 5, 8 to 12, 15 to 19, 22 to 26, and so on) dose of 90 mg and gemcitabine 1000 milligram per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks) then on Days 1, 8, and 15 of a 28-day cycle.
1264634|NCT01016483|O4|Outcome|Regimen 1: 68 mg|Subjects received pimasertib orally once daily (qd) 5-days-on / 2-days-off, continuously (Days 1 to 5, 8 to 12, 15 to 19, 22 to 26, and so on) dose of 68 mg and gemcitabine 1000 milligram per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks) then on Days 1, 8, and 15 of a 28-day cycle.
1264635|NCT01016483|O3|Outcome|Regimen 1: 45 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264636|NCT01016483|O2|Outcome|Regimen 1: 30 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264637|NCT01016483|O1|Outcome|Regimen 1: 15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264638|NCT01016483|O6|Outcome|Regimen 1: 120 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264639|NCT01016483|O5|Outcome|Regimen 1: 90 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264640|NCT01016483|O4|Outcome|Regimen 1: 68 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264641|NCT01016483|O3|Outcome|Regimen 1: 45 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264642|NCT01016483|O2|Outcome|Regimen 1: 30 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264643|NCT01016483|O1|Outcome|Regimen 1: 15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264644|NCT01016483|O2|Outcome|Safety Run-in Part: Regimen 2|Subjects received pimasertib capsule orally twice daily (bid) doses of 60 and 75 mg continuously for a 28-day cycle and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264645|NCT01016483|O1|Outcome|Safety Run-in Part: Regimen 1|Subjects received pimasertib capsule orally once daily (qd) doses of 15, 30, 45, 68, 90, and 120 milligram (mg) on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264646|NCT01016483|O2|Outcome|Phase II: Arm 2|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally 60 mg bid - continuous regimen.
1264647|NCT01016483|O1|Outcome|Phase II: Arm 1|Subjects received gemcitabine 1000 mg/m^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib capsule orally 60 mg bid - continuous regimen.
1264648|NCT01016483|O8|Outcome|Safety Run-in Part Regimen 2: 75 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (75 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
1264677|NCT00390455|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
1264649|NCT01016483|O7|Outcome|Safety Run-in Part Regimen 2: 60 mg|Subject received pimasertib capsule orally twice daily (bid) continuously for a 28-day cycle (60 mg bid - continuous regimen) and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1 = 8 weeks).
1264650|NCT01016483|O6|Outcome|Safety Run-in Part Regimen 1: 120 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 120 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264651|NCT01016483|O5|Outcome|Safety Run-in Part Regimen 1: 90 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 90 mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264652|NCT01016483|O4|Outcome|Safety Run-in Part Regimen 1: 68 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 68, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264653|NCT01016483|O3|Outcome|Safety Run-in Part Regimen 1: 45 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 45, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264654|NCT01016483|O2|Outcome|Safety Run-in Part Regimen 1: 30 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 30, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264655|NCT01016483|O1|Outcome|Safety Run-in Part Regimen 1: 15 mg|Subjects received pimasertib capsule orally once daily (qd) doses of 15, mg on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264656|NCT01016483|E4|Reported Event|Phase II: Arm 2|Subjects received gemcitabine 1000 mg/m^2 for 30 minutes IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib orally 60 mg bid - continuous regimen.
1264657|NCT01016483|E3|Reported Event|Phase II: Arm 1|Subjects received gemcitabine 1000 mg/m^2 for 30 minutes IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo orally bid - continuous regimen. Subjects with disease progression in Arm 1 were allowed crossover to receive pimasertib orally 60 mg bid - continuous regimen.
1264658|NCT01016483|E2|Reported Event|Safety Run-in Part: Regimen 2|Subjects received pimasertib capsule orally twice daily (bid) doses of 60 and 75 mg continuously for a 28-day cycle and gemcitabine 1000 mg/m^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264659|NCT01016483|E1|Reported Event|Safety Run-in Part: Regimen 1|Subjects received pimasertib capsule orally once daily (qd) doses of 15, 30, 45, 68, 90, and 120 milligram (mg) on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks).
1264660|NCT01012999|B1|Baseline|Intranasal Sufentanil, Pain Relief|"Patients with a suspected acute bony injury to an extremity and in moderate to severe pain.~Intranasal administration, 0.5 mcg/kg to an extremity and in moderate to severe pain, one time dose."
1264661|NCT01012999|P1|Participant Flow|Intranasal Sufentanil, Pain Relief|"Patients with a suspected acute bony injury to an extremity and in moderate to severe pain.~Intranasal administration, 0.5 mcg/kg, one time dose."
1264662|NCT01012999|O1|Outcome|Intranasal Sufentanil, Pain Relief|Patients with a suspected acute bony injury to an extremity and in moderate to severe pain
1264663|NCT01012999|E1|Reported Event|Intranasal Sufentanil, Pain Relief|Patients with a suspected acute bony injury to an extremity and in moderate to severe pain
1264664|NCT00390455|B3|Baseline|Total|Total of all reporting groups
1264665|NCT00390455|B2|Baseline|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
1264666|NCT00390455|B1|Baseline|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
1264667|NCT00390455|P2|Participant Flow|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
1264668|NCT00390455|P1|Participant Flow|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
1264669|NCT00390455|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
1264670|NCT00390455|O1|Outcome|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
1264671|NCT00390455|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
1264672|NCT00390455|O1|Outcome|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
1264673|NCT00390455|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
1264674|NCT00390455|O1|Outcome|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
1264678|NCT00390455|O1|Outcome|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
1264679|NCT00390455|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
1264680|NCT00390455|O1|Outcome|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
1264681|NCT00390455|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
1264682|NCT00390455|O1|Outcome|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
1264725|NCT00141921|P1|Participant Flow|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
1264726|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
1264727|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
1264728|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
1264729|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
1264730|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
1264731|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
1264732|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
1264733|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
1264734|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
1264735|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
1264736|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
1264737|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
1264738|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
1264739|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
1264740|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
1264741|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
1264742|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
1264743|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
1264744|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
1264745|NCT00141921|E1|Reported Event|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
1264746|NCT00125658|B3|Baseline|Total|Total of all reporting groups
1264747|NCT00125658|B2|Baseline|Order B|"Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).~Single, unilateral stroke, >6 <26 months post-event."
1264748|NCT00125658|B1|Baseline|Order A|"Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).~Single, unilateral stroke, >6 <26 months post-event."
1264749|NCT00125658|P2|Participant Flow|Order B (Power Prior to FTP)|Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).
1264750|NCT00125658|P1|Participant Flow|Order A (FTP Prior to Power)|Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).
1264751|NCT00125658|O2|Outcome|Order B|"Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).~Single, unilateral stroke, >6 <26 months post-event."
1264752|NCT00125658|O1|Outcome|Order A|"Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).~Single, unilateral stroke, >6 <26 months post-event."
1264753|NCT00125658|O2|Outcome|Order B|"Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).~Single, unilateral stroke, >6 <26 months post-event."
1264754|NCT00125658|O1|Outcome|Order A|"Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).~Single, unilateral stroke, >6 <26 months post-event."
1264755|NCT00125658|O2|Outcome|Order B|"Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).~Single, unilateral stroke, >6 <26 months post-event."
1264756|NCT00125658|O1|Outcome|Order A|"Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).~Single, unilateral stroke, >6 <26 months post-event."
1264757|NCT00125658|O2|Outcome|Order B|"Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).~Single, unilateral stroke, >6 <26 months post-event."
1264758|NCT00125658|O1|Outcome|Order A|"Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).~Single, unilateral stroke, >6 <26 months post-event."
1264759|NCT00125658|O2|Outcome|Order B|"Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).~Single, unilateral stroke, >6 <26 months post-event."
1264760|NCT00125658|O1|Outcome|Order A|"Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).~Single, unilateral stroke, >6 <26 months post-event."
1264761|NCT00125658|O2|Outcome|Order B|Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).
1264762|NCT00125658|O1|Outcome|Order A|Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).
1264763|NCT00125658|O2|Outcome|Order B|"Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).~Single, unilateral stroke, >6 <26 months post-event."
1264764|NCT00125658|O1|Outcome|Order A|"Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).~Single, unilateral stroke, >6 <26 months post-event."
1264765|NCT00125658|E2|Reported Event|Order B|"Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).~Single, unilateral stroke, >6 <26 months post-event."
1264766|NCT00125658|E1|Reported Event|Order A|"Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).~Single, unilateral stroke, >6 <26 months post-event."
1264767|NCT02482428|B6|Baseline|Total|Total of all reporting groups
1264768|NCT02482428|B5|Baseline|Aldara|Aldara 5% cream 3 applications per week for a maximum of 16 weeks
1264769|NCT02482428|B4|Baseline|Vehicle to LCC|Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
1264770|NCT02482428|B3|Baseline|Vehicle to NMC|Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
1264771|NCT02482428|B2|Baseline|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
1264772|NCT02482428|B1|Baseline|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
1264773|NCT02482428|P5|Participant Flow|Aldara|Aldara 5% cream 3 applications per week for a maximum of 16 weeks
1264774|NCT02482428|P4|Participant Flow|Vehicle to LCC|Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
1264775|NCT02482428|P3|Participant Flow|Vehicle to NMC|Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
1264776|NCT02482428|P2|Participant Flow|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
1264777|NCT02482428|P1|Participant Flow|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
1264778|NCT02482428|O4|Outcome|Aldara|Aldara 5% cream 3 applications per week for a maximum of 16 weeks
1264779|NCT02482428|O3|Outcome|Combined Vehicle|Vehicle to nanomedicinal cream (NMC) and Vehicle to liquid crystal cream (LCC) Twice daily applications
1264780|NCT02482428|O2|Outcome|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
1264781|NCT02482428|O1|Outcome|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
1264782|NCT02482428|O5|Outcome|Aldara|Aldara 5% cream 3 applications per week for a maximum of 16 weeks
1264788|NCT02482428|O3|Outcome|Combined Vehicle|Vehicle to nanomedicinal cream (NMC) and Vehicle to liquid crystal cream (LCC) Twice daily applications
1264789|NCT02482428|O2|Outcome|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
1264790|NCT02482428|O1|Outcome|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
1264791|NCT02482428|E5|Reported Event|Aldara|Aldara 5% cream 3 applications per week for a maximum of 16 weeks
1264792|NCT02482428|E4|Reported Event|Vehicle to LCC|Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
1264793|NCT02482428|E3|Reported Event|Vehicle to NMC|Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
1264794|NCT02482428|E2|Reported Event|LFX453 0.15% LCC|LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
1264795|NCT02482428|E1|Reported Event|LFX453 0.1% NMC|LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
1264796|NCT01639469|B3|Baseline|Total|Total of all reporting groups
1264797|NCT01639469|B2|Baseline|Lifestyle Exercise|"Lifestyle exercise program taught via smartphone~Lifestyle exercise: Subjects will be taught lifestyle exercises and advised about mobility strategies"
1264798|NCT01639469|B1|Baseline|Structured Exercise|"Structured exercise instruction by smartphone~Structured exercise: Structured exercise includes stretching, strengthening, and balance exercises."
1264799|NCT01639469|P2|Participant Flow|Lifestyle Exercise|"Lifestyle exercise program taught via smartphone~Lifestyle exercise: Subjects will be taught lifestyle exercises and advised about mobility strategies"
1264800|NCT01639469|P1|Participant Flow|Structured Exercise|"Structured exercise instruction by smartphone~Structured exercise: Structured exercise includes stretching, strengthening, and balance exercises."
1264801|NCT01639469|O2|Outcome|Lifestyle Exercise|"Lifestyle exercise program taught via smartphone~Lifestyle exercise: Subjects will be taught lifestyle exercises and advised about mobility strategies"
1264802|NCT01639469|O1|Outcome|Structured Exercise|"Structured exercise instruction by smartphone~Structured exercise: Structured exercise includes stretching, strengthening, and balance exercises."
1264803|NCT01639469|E2|Reported Event|Lifestyle Exercise|"Lifestyle exercise program taught via smartphone~Lifestyle exercise: Subjects will be taught lifestyle exercises and advised about mobility strategies"
1264804|NCT01639469|E1|Reported Event|Structured Exercise|"Structured exercise instruction by smartphone~Structured exercise: Structured exercise includes stretching, strengthening, and balance exercises."
1264805|NCT01261325|B4|Baseline|Total Title|
1264806|NCT01261325|B3|Baseline|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
1264807|NCT01261325|B2|Baseline|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
1264808|NCT01261325|B1|Baseline|Placebo|Matching placebo tablets administered twice daily
1264814|NCT01261325|O1|Outcome|Placebo|Matching placebo tablets administered twice daily
1264815|NCT01261325|O3|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
1264816|NCT01261325|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
1264817|NCT01261325|O1|Outcome|Placebo|Matching placebo tablets administered twice daily
1264818|NCT01261325|O3|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
1264819|NCT01261325|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
1264820|NCT01261325|O1|Outcome|Placebo|Matching placebo tablets administered twice daily
1264821|NCT01261325|O3|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
1264822|NCT01261325|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
1264823|NCT01261325|O1|Outcome|Placebo|Matching placebo tablets administered twice daily
1264824|NCT01261325|O3|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
1264825|NCT01261325|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
1264826|NCT01261325|O1|Outcome|Placebo|Matching placebo tablets administered twice daily
1264827|NCT01261325|O3|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
1264828|NCT01261325|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
1264829|NCT01261325|O1|Outcome|Placebo|Matching placebo tablets administered twice daily
1264830|NCT01261325|O3|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
1264831|NCT01261325|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
1264832|NCT01261325|O1|Outcome|Placebo|Matching placebo tablets administered twice daily
1264833|NCT01261325|O3|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
1264834|NCT01261325|O2|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
1264835|NCT01261325|O1|Outcome|Placebo|Matching placebo tablets administered twice daily
1264836|NCT01261325|O3|Outcome|Placebo|Matching placebo tablets administered twice daily
1264837|NCT01261325|O2|Outcome|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
1264838|NCT01261325|O1|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
1264839|NCT01261325|E3|Reported Event|Brivaracetam 200 mg/Day|Brivaracetam 100 mg administered twice daily
1264840|NCT01261325|E2|Reported Event|Brivaracetam 100 mg/Day|Brivaracetam 50 mg administered twice daily
1264841|NCT01261325|E1|Reported Event|Placebo|Matching placebo tablets administered twice daily
1264876|NCT00378703|O2|Outcome|Arm B (Bevacizumab and Temsirolimus)|"Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.~temsirolimus: Given IV~bevacizumab: Given IV"
1264842|NCT01161121|B1|Baseline|Adenosine, Regadenoson|Each patient underwent standard intravenous adenosine infusion (140mcg/kg/min) with invasive pressure recordings for 2 min, or until maximal hyperemia occurred. Five minutes after return to baseline hemodynamics, a single intravenous bolus of 0.4 mg regadenoson was administered, and pressures were recorded for 5 min. FFR values were compared by linear regression and Bland-Altman analysis.
1264843|NCT01161121|P1|Participant Flow|Adenosine Then Regadenoson|"Adenosine infusion will be compared to Regadenoson for efficacy and safety/side effects. Arterial blood pressure, coronary pressure, heart rate, oxygen saturation and coronary flow, FFR, and coronary flow velocity will be assessed. Safety will be assessed by monitoring for any side effects such as chest pain, headache, flushing, nausea, or arrhythmias. All patients to receive Adenosine infusion followed by Regadenoson IV bolus upon return of coronary flow velocity to 15% of pre-dose value.~Adenosine : Injection of IV Adenosine for 2 minutes at rate of 140mcg/kg to dilate coronary arteries and provoke maximal hyperemia.~Regadenoson : Administration of IV regadenoson bolus 0.4 mg/5 mls over 10 seconds followed by a 5 cc NS saline flush"
1264844|NCT01161121|O2|Outcome|Regadenoson|"Once the mean coronary flow velocity returns to within 15% pre-dose value following IV infusion of Adenosine, Regadenoson IV injection will be given at 0.4 mg 5/ml- 0.08mg/ml over 10 seconds followed by a 5 cc IV saline flush.~regadenoson : Measuring FFR and Coronary Flow Reserve after administration of IV regadenoson 0.4 mg over 10 seconds."
1264845|NCT01161121|O1|Outcome|Adenosine|"Adenosine infusion will be compared to Regadenoson for safety/side effects. Arterial blood pressure, coronary pressure, heart rate, oxygen saturation and coronary flow, FFR, and coronary flow velocity will be assessed. Safety will be assessed by monitoring for any side effects such as chest pain, headache, flushing, nausea, or arrhythmias.~Adenosine : Injection of IV Adenosine for 2 minutes at rate of 140mcg/kg to dilate coronary arteries and provoke maximal hyperemia"
1264846|NCT01161121|O2|Outcome|Regadenosine|With bolus infusion of 0.4 mg
1264847|NCT01161121|O1|Outcome|Adenosine|With infusion of 140 mcg/kg/min
1264848|NCT01161121|O2|Outcome|Regadenoson|"Once the mean coronary flow velocity returns to within 15% pre-dose value following IV infusion of Adenosine, Regadenoson IV injection will be given at 0.4 mg 5/ml- 0.08mg/ml over 10 seconds followed by a 5 cc IV saline flush.~regadenoson : Measuring FFR and Coronary Flow Reserve after administration of IV regadenoson 0.4 mg over 10 seconds."
1264849|NCT01161121|O1|Outcome|Adenosine|"Adenosine infusion will be compared to Regadenoson for safety/side effects. Arterial blood pressure, coronary pressure, heart rate, oxygen saturation and coronary flow, FFR, and coronary flow velocity will be assessed. Safety will be assessed by monitoring for any side effects such as chest pain, headache, flushing, nausea, or arrhythmias.~Adenosine : Injection of IV Adenosine for 2 minutes at rate of 140mcg/kg to dilate coronary arteries and provoke maximal hyperemia"
1264850|NCT01161121|E2|Reported Event|Regadenoson|"Once the mean coronary flow velocity returns to within 15% pre-dose value then Regadenoson IV injection will be given at 0.4 mg 5/ml- 0.08mg/ml. Then, a 5 cc saline flush will be administered.~regadenoson : Measuring FFR and Coronary Flow Reserve after administration of IV regadenoson 0.4 mg over 10 seconds."
1264892|NCT00378703|E2|Reported Event|Arm B (Bevacizumab and Temsirolimus)|Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.
1264893|NCT00378703|E1|Reported Event|Arm A (Bevacizumab)|Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.
1264851|NCT01161121|E1|Reported Event|Adenosine|"Adenosine infusion will be compared to Regadenoson for safety/side effects. Arterial blood pressure, coronary pressure, heart rate, oxygen saturation and coronary flow, FFR, and coronary flow velocity will be assessed. Safety will be assessed by monitoring for any side effects such as chest pain, headache, flushing, nausea, or arrhythmias.~Adenosine : Injection of IV Adenosine for 2 minutes at rate of 140mcg/kg to dilate coronary arteries and provoke maximal hyperemia~adenosine : Measuring FFR and Coronary Flow Reserve after administration of IV adenosine 140 mcg/kg/min for 2 minutes.~regadenoson : Measuring FFR and Coronary Flow Reserve after administration of IV regadenoson 0.4 mg over 10 seconds."
1264852|NCT01134614|B3|Baseline|Total|Total of all reporting groups
1264853|NCT01134614|B2|Baseline|Arm B (Ipilimumab)|"ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.~ipilimumab: Given IV"
1264854|NCT01134614|B1|Baseline|Arm A (Ipilimumab and Sargramostim)|"ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.~ipilimumab: Given IV~sargramostim: Given SC"
1264855|NCT01134614|P2|Participant Flow|Arm B (Ipilimumab)|"ARM B: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, anti-tumor response is assessed and patients then receive maintenance therapy of ipilimumab IV over 90 minutes on day 1. Treatment with ipilimumab repeats every 12 weeks. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.~ipilimumab: Given IV"
1264856|NCT01134614|P1|Participant Flow|Arm A (Ipilimumab and Sargramostim)|"ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, anti-tumor response is assessed and patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.~ipilimumab: Given IV~sargramostim: Given SC"
1264877|NCT00378703|O1|Outcome|Arm A (Bevacizumab)|"Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.~bevacizumab: Given IV"
1264878|NCT00378703|O4|Outcome|Arm D (Sorafenib and Temsirolimus)|"Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.~Sorafenib: Given PO~temsirolimus: Given IV"
1264857|NCT01134614|O2|Outcome|Arm B (Ipilimumab)|"ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.~ipilimumab: Given IV"
1264858|NCT01134614|O1|Outcome|Arm A (Ipilimumab and Sargramostim)|"ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.~ipilimumab: Given IV~sargramostim: Given SC"
1264859|NCT01134614|O2|Outcome|Arm B (Ipilimumab)|"ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.~ipilimumab: Given IV"
1264860|NCT01134614|O1|Outcome|Arm A (Ipilimumab and Sargramostim)|"ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.~ipilimumab: Given IV~sargramostim: Given SC"
1264861|NCT01134614|O2|Outcome|Arm B (Ipilimumab)|"ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.~ipilimumab: Given IV"
1264894|NCT00280748|B1|Baseline|Single Arm Study|"Single Arm Study~pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days~radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
1265050|NCT01061736|O1|Outcome|Part B: SAR 150 mg q2w|Participants randomized after dose selection received Sarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
1264862|NCT01134614|O1|Outcome|Arm A (Ipilimumab and Sargramostim)|"ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.~ipilimumab: Given IV~sargramostim: Given SC"
1264863|NCT01134614|E2|Reported Event|Arm B (Ipilimumab)|ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
1264864|NCT01134614|E1|Reported Event|Arm A (Ipilimumab and Sargramostim)|ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.
1264865|NCT00378703|B5|Baseline|Total|Total of all reporting groups
1264866|NCT00378703|B4|Baseline|Arm D (Sorafenib and Temsirolimus)|Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.
1264867|NCT00378703|B3|Baseline|Arm C (Bevacizumab and Sorafenib)|Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.
1264868|NCT00378703|B2|Baseline|Arm B (Bevacizumab and Temsirolimus)|Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.
1264869|NCT00378703|B1|Baseline|Arm A (Bevacizumab)|Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.
1264870|NCT00378703|P4|Participant Flow|Arm D (Sorafenib and Temsirolimus)|"Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.~Sorafenib: Given PO~temsirolimus: Given IV"
1264871|NCT00378703|P3|Participant Flow|Arm C (Bevacizumab and Sorafenib)|"Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.~Sorafenib: Given PO~bevacizumab: Given IV"
1264872|NCT00378703|P2|Participant Flow|Arm B (Bevacizumab and Temsirolimus)|"Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.~temsirolimus: Given IV~bevacizumab: Given IV"
1264873|NCT00378703|P1|Participant Flow|Arm A (Bevacizumab)|"Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.~bevacizumab: Given IV"
1264874|NCT00378703|O4|Outcome|Arm D (Sorafenib and Temsirolimus)|"Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.~Sorafenib: Given PO~temsirolimus: Given IV"
1264875|NCT00378703|O3|Outcome|Arm C (Bevacizumab and Sorafenib)|"Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.~Sorafenib: Given PO~bevacizumab: Given IV"
1264879|NCT00378703|O3|Outcome|Arm C (Bevacizumab and Sorafenib)|"Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.~Sorafenib: Given PO~bevacizumab: Given IV"
1264880|NCT00378703|O2|Outcome|Arm B (Bevacizumab and Temsirolimus)|"Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.~temsirolimus: Given IV~bevacizumab: Given IV"
1264881|NCT00378703|O1|Outcome|Arm A (Bevacizumab)|"Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.~bevacizumab: Given IV"
1264882|NCT00378703|O4|Outcome|Arm D (Sorafenib and Temsirolimus)|"Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.~Sorafenib: Given PO~temsirolimus: Given IV"
1264883|NCT00378703|O3|Outcome|Arm C (Bevacizumab and Sorafenib)|"Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.~Sorafenib: Given PO~bevacizumab: Given IV"
1264884|NCT00378703|O2|Outcome|Arm B (Bevacizumab and Temsirolimus)|"Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.~temsirolimus: Given IV~bevacizumab: Given IV"
1264885|NCT00378703|O1|Outcome|Arm A (Bevacizumab)|"Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.~bevacizumab: Given IV"
1264886|NCT00378703|O4|Outcome|Arm D (Sorafenib and Temsirolimus)|"Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.~Sorafenib: Given PO~temsirolimus: Given IV"
1264887|NCT00378703|O3|Outcome|Arm C (Bevacizumab and Sorafenib)|"Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.~Sorafenib: Given PO~bevacizumab: Given IV"
1264888|NCT00378703|O2|Outcome|Arm B (Bevacizumab and Temsirolimus)|"Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.~temsirolimus: Given IV~bevacizumab: Given IV"
1264889|NCT00378703|O1|Outcome|Arm A (Bevacizumab)|"Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.~bevacizumab: Given IV"
1264890|NCT00378703|E4|Reported Event|Arm D (Sorafenib and Temsirolimus)|Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.
1264891|NCT00378703|E3|Reported Event|Arm C (Bevacizumab and Sorafenib)|Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.
1264895|NCT00280748|P1|Participant Flow|Single Arm Study|"Single Arm Study~pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days~radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
1264896|NCT00280748|O1|Outcome|Single Arm Study|"Single Arm Study~pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days~radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
1264897|NCT00280748|O1|Outcome|Single Arm Study|"Single Arm Study~pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days~radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
1264898|NCT00280748|O1|Outcome|Single Arm Study|"Single Arm Study~pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days~radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
1264899|NCT00280748|O1|Outcome|Single Arm Study|"Single Arm Study~pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days~radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
1264900|NCT00280748|O1|Outcome|Single Arm Study|"Single Arm Study~pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days~radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
1264901|NCT00280748|O1|Outcome|Single Arm Study|"Single Arm Study~pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days~radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
1264902|NCT00280748|O1|Outcome|Single Arm Study|"Single Arm Study~pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days~radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
1264903|NCT00280748|E1|Reported Event|Single Arm Study|"Single Arm Study~pemetrexed disodium: 500 mg/m2 once every 21 days up to 126 days~radiation therapy: Patients will receive cranial irradiation at 2.5 Gy per fraction, 5 days a week, for 3 weeks to a total dose of 37.5 Gy"
1264904|NCT02234362|B1|Baseline|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
1264905|NCT02234362|P1|Participant Flow|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
1264906|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
1264907|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
1264908|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
1264909|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
1264910|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
1264911|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
1264912|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
1264913|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
1264914|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
1264915|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
1264916|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
1264917|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
1264918|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
1264919|NCT02234362|O1|Outcome|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
1264920|NCT02234362|E1|Reported Event|Open-label Vortioxetine|"Flexible-dose vortioxetine of 5-20 mg depending on tolerability~Vortioxetine: Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability."
1264921|NCT01681849|B4|Baseline|Total|Total of all reporting groups
1264922|NCT01681849|B3|Baseline|PTSD Negative|"Women who have experienced early childhood abuse and do not have PTSD served as a control group and completed baseline assessments~Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
1264934|NCT01681849|E1|Reported Event|Paroxetine Group|"Women who have experienced early childhood abuse and have PTSD will be randomized in a double blind fashion to receive paroxetine for a three month period followed by an open label phase of three months.~Paroxetine: Following a three month double blind phase, subjects will be treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Positron Emission Tomography (PET) Imaging: Participants will undergo positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
1264923|NCT01681849|B2|Baseline|Placebo Group|"Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive placebo for a three month period followed by an open label phase of paroxetine for three months.~Placebo: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
1264924|NCT01681849|B1|Baseline|Paroxetine Group|"Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive paroxetine for a three month period followed by an open label phase of three months.~Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
1264925|NCT01681849|P3|Participant Flow|PTSD Negative|"Women who have experienced early childhood abuse and do not have PTSD served as a control group and completed baseline assessments~Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
1264926|NCT01681849|P2|Participant Flow|Placebo Group|"Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive placebo for a three month period followed by an open label phase of paroxetine for three months.~Placebo: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
1264927|NCT01681849|P1|Participant Flow|Paroxetine Group|"Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive paroxetine for a three month period followed by an open label phase of three months.~Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
1264993|NCT01188681|E4|Reported Event|Phase 2:Bendamustine|"Bendamustine alone (70 mg/m2)~Bendamustine: 70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
1264994|NCT01188681|E3|Reported Event|Phase 2: TRU-016 and Bendamustine|"TRU-016 (20 mg/kg) and bendamustine (70 mg/m2)~TRU-016 and bendamustine: TRU-016 (20 mg/kg) weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
1264928|NCT01681849|O2|Outcome|Placebo Group|"Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive placebo for a three month period followed by an open label phase of paroxetine for three months.~Placebo: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
1264929|NCT01681849|O1|Outcome|Paroxetine Group|"Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive paroxetine for a three month period followed by an open label phase of three months.~Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
1264930|NCT01681849|O2|Outcome|Placebo Group|"Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive placebo for a three month period followed by an open label phase of paroxetine for three months.~Placebo: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
1264931|NCT01681849|O1|Outcome|Paroxetine Group|"Women who have experienced early childhood abuse and have PTSD were randomized in a double blind fashion to receive paroxetine for a three month period followed by an open label phase of three months.~Paroxetine: Following a three month double blind phase, subjects were treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Positron Emission Tomography (PET) Imaging: Participants underwent positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
1264932|NCT01681849|E3|Reported Event|PTSD Negative|"Women who have experienced early childhood abuse and do not have PTSD will serve as a control group and complete baseline assessments~Positron Emission Tomography (PET) Imaging: Participants will undergo positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
1264933|NCT01681849|E2|Reported Event|Placebo Group|"Women who have experienced early childhood abuse and have PTSD will be randomized in a double blind fashion to receive placebo for a three month period followed by an open label phase of paroxetine for three months.~Placebo: Following a three month double blind phase, subjects will be treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Paroxetine: Following a three month double blind phase, subjects will be treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.~Positron Emission Tomography (PET) Imaging: Participants will undergo positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water while completing memory tasks."
1264980|NCT01188681|B1|Baseline|Phase 1: 15 mg/kg TRU-016|"TRU-016 (15 mg/kg) and bendamustine (70 mg/m2)~TRU-016 and bendamustine: TRU-016 (20 mg/kg) weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
1264935|NCT01656252|B1|Baseline|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
1264936|NCT01656252|P1|Participant Flow|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
1264937|NCT01656252|O3|Outcome|Phase II- Sequence B|"Cytarabine twice daily on Days 1, 3 and 5. Placebo with 1st cycle of high-dose consolidation therapy and Eltrombopag(dose and schedule as determined in Phase I) with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence B: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Placebo by mouth daily with 1st cycle of high-dose consolidation therapy and Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
1264995|NCT01188681|E2|Reported Event|Phase 1: 20 mg/kg|TRU-016 (20 mg/kg), weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
1264996|NCT01188681|E1|Reported Event|Phase 1: 15 mg/kg|TRU-016 (15 mg/kg), weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
1264997|NCT01153815|B3|Baseline|Total|Total of all reporting groups
1264938|NCT01656252|O2|Outcome|Phase II- Sequence A|"Cytarabine twice daily on Days 1, 3 and 5. Eltrombopag(dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence A: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo by mouth daily with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
1264939|NCT01656252|O1|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
1264940|NCT01656252|O3|Outcome|Phase II- Sequence B|"Cytarabine twice daily on Days 1, 3 and 5. Placebo with 1st cycle of high-dose consolidation therapy and Eltrombopag(dose and schedule as determined in Phase I) with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence B: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Placebo by mouth daily with 1st cycle of high-dose consolidation therapy and Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
1264941|NCT01656252|O2|Outcome|Phase II- Sequence A|"Cytarabine twice daily on Days 1, 3 and 5. Eltrombopag(dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence A: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo by mouth daily with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
1264942|NCT01656252|O1|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
1264981|NCT01188681|P4|Participant Flow|Phase 2 Bendamustine|Patients in the bendamustine arm received bendamustine (70 mg/m2) administered IV on Days 1 and 2 of each cycle for up to six 28-day cycles.
1264982|NCT01188681|P3|Participant Flow|Phase 2 TRU-016 and Bendamustine|Patients in the combination arm received otlertuzumab (20 mg/kg) weekly by IV infusion for two 28-day cycles then every 14 days for four 28-day cycles. In both arms, bendamustine (70 mg/m2) was administered IV on Days 1 and 2 of each cycle for up to six 28-day cycles.
1264943|NCT01656252|O3|Outcome|Phase II- Sequence B|"Cytarabine twice daily on Days 1, 3 and 5. Placebo with 1st cycle of high-dose consolidation therapy and Eltrombopag(dose and schedule as determined in Phase I) with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence B: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Placebo by mouth daily with 1st cycle of high-dose consolidation therapy and Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
1264944|NCT01656252|O2|Outcome|Phase II- Sequence A|"Cytarabine twice daily on Days 1, 3 and 5. Eltrombopag(dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence A: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo by mouth daily with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
1264945|NCT01656252|O1|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
1265048|NCT01061736|O3|Outcome|Part B: Placebo q2w|Participants randomized after dose selection received Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks.
1264946|NCT01656252|O3|Outcome|Phase II- Sequence B|"Cytarabine twice daily on Days 1, 3 and 5. Placebo with 1st cycle of high-dose consolidation therapy and Eltrombopag(dose and schedule as determined in Phase I) with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence B: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Placebo by mouth daily with 1st cycle of high-dose consolidation therapy and Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
1264947|NCT01656252|O2|Outcome|Phase II- Sequence A|"Cytarabine twice daily on Days 1, 3 and 5. Eltrombopag(dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence A: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo by mouth daily with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
1264948|NCT01656252|O1|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
1264949|NCT01656252|O3|Outcome|Phase II- Sequence B|"Cytarabine twice daily on Days 1, 3 and 5. Placebo with 1st cycle of high-dose consolidation therapy and Eltrombopag(dose and schedule as determined in Phase I) with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence B: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Placebo by mouth daily with 1st cycle of high-dose consolidation therapy and Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
1264950|NCT01656252|O2|Outcome|Phase II- Sequence A|"Cytarabine twice daily on Days 1, 3 and 5. Eltrombopag(dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence A: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo by mouth daily with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
1264959|NCT01656252|O2|Outcome|Phase II- Sequence A|"Cytarabine twice daily on Days 1, 3 and 5. Eltrombopag(dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence A: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo by mouth daily with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
1264951|NCT01656252|O1|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
1264952|NCT01656252|O3|Outcome|Phase II- Sequence B|"Cytarabine twice daily on Days 1, 3 and 5. Placebo with 1st cycle of high-dose consolidation therapy and Eltrombopag(dose and schedule as determined in Phase I) with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence B: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Placebo by mouth daily with 1st cycle of high-dose consolidation therapy and Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
1264953|NCT01656252|O2|Outcome|Phase II- Sequence A|"Cytarabine twice daily on Days 1, 3 and 5. Eltrombopag(dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence A: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo by mouth daily with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
1264954|NCT01656252|O1|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
1264955|NCT01656252|O3|Outcome|Phase II- Sequence B|"Cytarabine twice daily on Days 1, 3 and 5. Placebo with 1st cycle of high-dose consolidation therapy and Eltrombopag(dose and schedule as determined in Phase I) with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence B: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Placebo by mouth daily with 1st cycle of high-dose consolidation therapy and Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
1264956|NCT01656252|O2|Outcome|Phase II- Sequence A|"Cytarabine twice daily on Days 1, 3 and 5. Eltrombopag(dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence A: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo by mouth daily with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
1264957|NCT01656252|O1|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
1264958|NCT01656252|O3|Outcome|Phase II- Sequence B|"Cytarabine twice daily on Days 1, 3 and 5. Placebo with 1st cycle of high-dose consolidation therapy and Eltrombopag(dose and schedule as determined in Phase I) with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence B: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Placebo by mouth daily with 1st cycle of high-dose consolidation therapy and Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
1264973|NCT01317901|O1|Outcome|TRU-016 (10 mg/kg) + Bendamustine + Rituximab|"10 mg/kg of TRU 016 combined with rituximab 375 mg/m^2 and bendamustine 90 mg/m^2 were evaluated during up to 6 cycles (28 days each). TRU-016 was administered by intravenous (IV) infusion on Days 1 and 15 of each cycle. Rituximab was administered by IV infusion on Day 2 of each cycle. Bendamustine was administered by IV infusion on Days 1 and 2 of each cycle. Subjects received study treatment for up to 6 cycles.~TRU-016: 100 mg TRU-016 lyophilized solution for infusion at 10 or 20 mg/kg (or 6 mg/kg, if necessary) on Days 1 and 15 of each 28 day cycle~Bendamustine: Bendamustine by IV administration on Days 1 and 2 of each 28 day cycle.~Rituximab: Rituximab by IV administration at 375 mg/m^2 on Day 2 of each 28 day cycle."
1264960|NCT01656252|O1|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
1264961|NCT01656252|O3|Outcome|Phase II- Sequence B|"Cytarabine twice daily on Days 1, 3 and 5. Placebo with 1st cycle of high-dose consolidation therapy and Eltrombopag(dose and schedule as determined in Phase I) with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence B: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Placebo by mouth daily with 1st cycle of high-dose consolidation therapy and Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
1264962|NCT01656252|O2|Outcome|Phase II- Sequence A|"Cytarabine twice daily on Days 1, 3 and 5. Eltrombopag(dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo with 2nd cycle. Treatment sequence will be blinded to the patient and all study/sponsor personnel.~Phase II- Sequence A: Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo by mouth daily with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
1264963|NCT01656252|O1|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
1264964|NCT01656252|O1|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
1264965|NCT01656252|O1|Outcome|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
1264966|NCT01656252|E1|Reported Event|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine twice daily on Days 1, 3 and 5 and Eltrombopag (Open-Label) until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~Phase I- Cytarabine & Eltrombopag: Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
1264967|NCT01317901|B3|Baseline|Total|Total of all reporting groups
1264968|NCT01317901|B2|Baseline|TRU-016 (20 mg/kg) +Bendamustine+Rituximab|
1264969|NCT01317901|B1|Baseline|TRU-016 (10 mg/kg) +Bendamustine+Rituximab|
1264970|NCT01317901|P2|Participant Flow|20 mg/kg TRU-016+Bendamustine+Rituximab|"TRU-016: 100 mg TRU-016 lyophilized solution for infusion at 10 mg/kg (or 6 mg/kg, if necessary) on Days 1 and 15 of each 28 day cycle Rituximab: 375 mg/m^2 rituximab was administered by IV infusion on Day 2 of each cycle.~Bendamustine: 90 mg/m^2 bendamustine was administered by IV infusion on Days 1 and 2 of each cycle."
1264971|NCT01317901|P1|Participant Flow|10 mg/kg TRU-016+Bendamustine+Rituximab|"TRU-016: 100 mg TRU-016 lyophilized solution for infusion at 10 mg/kg (or 6 mg/kg, if necessary) on Days 1 and 15 of each 28 day cycle Rituximab: 375 mg/m^2 rituximab was administered by IV infusion on Day 2 of each cycle.~Bendamustine: 90 mg/m^2 bendamustine was administered by IV infusion on Days 1 and 2 of each cycle."
1264972|NCT01317901|O2|Outcome|20 mg/kg of TRU 016 + Bendamustine + Rituximab|20 mg/kg of TRU 016 combined with rituximab 375 mg/m^2 and bendamustine 90 mg/m^2 were evaluated during up to 6 cycles (28 days each). TRU-016 was administered by intravenous (IV) infusion on Days 1 and 15 of each cycle. Rituximab was administered by IV infusion on Day 2 of each cycle. Bendamustine was administered by IV infusion on Days 1 and 2 of each cycle. Subjects received study treatment for up to 6 cycles.
1264983|NCT01188681|P2|Participant Flow|Phase 1 20 mg/kg|TRU-016 (20 mg/kg), weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles and bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
1264984|NCT01188681|P1|Participant Flow|Phase 1 15 mg/kg|TRU-016 (15 mg/kg), weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles and bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
1264985|NCT01188681|O4|Outcome|Phase 1: 20 mg/kg TRU-016 +Bendamustine|TRU-016 and bendamustine: TRU-016 (n = 6 patients), 20 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
1264986|NCT01188681|O3|Outcome|Phase 1: 15 mg/kg TRU-016 +Beendamustine|TRU-016 and bendamustine: TRU-016 (n = 6 patients), 15 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
1264987|NCT01188681|O2|Outcome|Phase 2: Bendamustine|"Bendamustine alone (n = 33 patients) (70 mg/m2)~Bendamustine: 70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
1264988|NCT01188681|O1|Outcome|Phase 2: TRU-016 and Bendamustine|"TRU-016 (n = 32 patients), 20 mg/kg and bendamustine (70 mg/m2)~TRU-016 and bendamustine: TRU-016 (n = 33 patients), 20 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
1264989|NCT01188681|O4|Outcome|Bendamustine|"Bendamustine alone (n = 33 patients) (70 mg/m2)~Bendamustine: 70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
1264990|NCT01188681|O3|Outcome|TRU-016 and Bendamustine|"TRU-016 (n = 32 patients), 20 mg/kg and bendamustine (70 mg/m2)~TRU-016 and bendamustine: TRU-016 (n = 33 patients), 20 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles"
1264991|NCT01188681|O2|Outcome|Phase 1 20 mg/kg TRU-016|20 mg/kg TRU-016 + 70 mg/m2 bendamustine (n=6) dose group
1264992|NCT01188681|O1|Outcome|Phase 1 15 mg/kg TRU-016|15 mg/kg TRU-016 + 70 mg/m2 bendamustine (n=6) dose group
1264998|NCT01153815|B2|Baseline|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
1264999|NCT01153815|B1|Baseline|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
1265000|NCT01153815|P2|Participant Flow|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
1265001|NCT01153815|P1|Participant Flow|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
1265002|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
1265003|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
1265004|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
1265005|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
1265006|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
1265007|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
1265008|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
1265009|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
1265010|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
1265011|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
1265012|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
1265013|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
1265014|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
1265015|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
1265016|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
1265017|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
1265018|NCT01153815|O2|Outcome|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
1265019|NCT01153815|O1|Outcome|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
1265020|NCT01153815|E2|Reported Event|BTX 200 U|Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
1265021|NCT01153815|E1|Reported Event|Placebo|Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
1265022|NCT01076270|B1|Baseline|Filgrastim and Plerixafor for PBSC Mobilization|"Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells.~After completion of study treatment, donors are followed up 1 day after the last stem cell donation.~plerixafor: Given SC~filgrastim: Given SC~peripheral blood stem cell transplantation: Infusion of peripheral blood stem cells~allogeneic hematopoietic stem cell transplantation: Infusion of hematopoietic stem cells"
1265049|NCT01061736|O2|Outcome|Part B: SAR 200 mg q2w|Participants randomized after dose selection received Sarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
1265023|NCT01076270|P1|Participant Flow|Filgrastim and Plerixafor for PBSC Mobilization|"Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells.~After completion of study treatment, donors are followed up 1 day after the last stem cell donation.~plerixafor: Given SC~filgrastim: Given SC~peripheral blood stem cell transplantation: Infusion of peripheral blood stem cells~allogeneic hematopoietic stem cell transplantation: Infusion of hematopoietic stem cells"
1265024|NCT01076270|O1|Outcome|Filgrastim and Plerixafor for PBSC Mobilization|"Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells.~After completion of study treatment, donors are followed up 1 day after the last stem cell donation.~plerixafor: Given SC~filgrastim: Given SC~peripheral blood stem cell transplantation: Infusion of peripheral blood stem cells~allogeneic hematopoietic stem cell transplantation: Infusion of hematopoietic stem cells"
1265025|NCT01076270|O1|Outcome|Filgrastim and Plerixafor for PBSC Mobilization|"Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells.~After completion of study treatment, donors are followed up 1 day after the last stem cell donation.~plerixafor: Given SC~filgrastim: Given SC~peripheral blood stem cell transplantation: Infusion of peripheral blood stem cells~allogeneic hematopoietic stem cell transplantation: Infusion of hematopoietic stem cells"
1265026|NCT01076270|E1|Reported Event|Filgrastim and Plerixafor for PBSC Mobilization|"Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells.~After completion of study treatment, donors are followed up 1 day after the last stem cell donation.~plerixafor: Given SC~filgrastim: Given SC~peripheral blood stem cell transplantation: Infusion of peripheral blood stem cells~allogeneic hematopoietic stem cell transplantation: Infusion of hematopoietic stem cells"
1265027|NCT01061736|B11|Baseline|Total|Total of all reporting groups
1265028|NCT01061736|B10|Baseline|Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2)|Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
1265029|NCT01061736|B9|Baseline|Part B: SAR 200 mg q2w (Cohort 1[Selected Dose]+Cohort 2)|Sarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
1265030|NCT01061736|B8|Baseline|Part B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2)|Sarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
1265031|NCT01061736|B7|Baseline|Part B Cohort 1: Non-selected Doses|Sarilumab 100 mg qw, 150 mg qw or 100 mg q2w SC injections on top of MTX up to dose selection. After dose selection, participants were not continued but were allowed to participate in the open-label, long-term, extension study SARIL-RA-EXTEND (LTS11210).
1265032|NCT01061736|B6|Baseline|Part A: Placebo qw|Placebo (for sarilumab) qw on top of MTX for 12 weeks.
1265033|NCT01061736|B5|Baseline|Part A: SAR 200 mg q2w|Sarilumab 200 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
1265034|NCT01061736|B4|Baseline|Part A: SAR 150 mg q2w|Sarilumab 150 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
1265035|NCT01061736|B3|Baseline|Part A: SAR 100 mg q2w|Sarilumab 100 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
1265036|NCT01061736|B2|Baseline|Part A: SAR 150 mg qw|Sarilumab 150 mg SC injection qw on top of MTX for 12 weeks.
1265037|NCT01061736|B1|Baseline|Part A: SAR 100 mg qw|Sarilumab 100 mg SC injection qw on top of MTX for 12 weeks.
1265038|NCT01061736|P10|Participant Flow|Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2)|Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
1265039|NCT01061736|P9|Participant Flow|Part B: SAR 200 mg q2w (Cohort 1 [Selected Dose]+Cohort 2)|Sarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
1265040|NCT01061736|P8|Participant Flow|Part B: SAR 150 mg q2w (Cohort 1 [Selected Dose]+Cohort 2)|Sarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
1265041|NCT01061736|P7|Participant Flow|Part B Cohort 1: Non-selected Doses|Sarilumab 100 mg qw, 150 mg qw or 100 mg q2w SC injections as in Part A on top of MTX up to dose selection. After dose selection, participants were not continued but were allowed to participate in the open-label, long-term, extension study SARIL-RA-EXTEND (LTS11210).
1265042|NCT01061736|P6|Participant Flow|Part A: Placebo qw|Placebo (for sarilumab) qw on top of MTX for 12 weeks.
1265043|NCT01061736|P5|Participant Flow|Part A: SAR 200 mg q2w|Sarilumab 200 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
1265044|NCT01061736|P4|Participant Flow|Part A: SAR 150 mg q2w|Sarilumab 150 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
1265045|NCT01061736|P3|Participant Flow|Part A: SAR 100 mg q2w|Sarilumab 100 mg SC injection every other week (q2w) alternating with placebo on top of MTX for 12 weeks.
1265046|NCT01061736|P2|Participant Flow|Part A: SAR 150 mg qw|Sarilumab 150 mg SC injection qw on top of MTX for 12 weeks.
1265047|NCT01061736|P1|Participant Flow|Part A: SAR 100 mg qw|Sarilumab 100 mg subcutaneous (SC) injection weekly (qw) on top of methotrexate (MTX) for 12 weeks.
1265051|NCT01061736|O3|Outcome|Part B: Placebo q2w|Participants randomized after dose selection received Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks.
1265052|NCT01061736|O2|Outcome|Part B: SAR 200 mg q2w|Participants randomized after dose selection received Sarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
1265053|NCT01061736|O1|Outcome|Part B: SAR 150 mg q2w|Participants randomized after dose selection received Sarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
1265054|NCT01061736|O3|Outcome|Part B: Placebo q2w|Participants randomized after dose selection received Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks.
1265055|NCT01061736|O2|Outcome|Part B: SAR 200 mg q2w|Participants randomized after dose selection received Sarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
1265056|NCT01061736|O1|Outcome|Part B: SAR 150 mg q2w|Participants randomized after dose selection received Sarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
1265057|NCT01061736|O3|Outcome|Part B: Placebo q2w|Participants randomized after dose selection received Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks
1265058|NCT01061736|O2|Outcome|Part B: SAR 200 mg q2w|Participants randomized after dose selection received Sarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
1265059|NCT01061736|O1|Outcome|Part B: SAR 150 mg q2w|Participants randomized after dose selection received Sarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks.
1265060|NCT01061736|O6|Outcome|Part A: Placebo qw|Placebo (for sarilumab) qw on top of MTX for 12 weeks.
1265061|NCT01061736|O5|Outcome|Part A: SAR 200 mg q2w|Sarilumab 200 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
1265062|NCT01061736|O4|Outcome|Part A: SAR 150 mg q2w|Sarilumab 150 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
1265063|NCT01061736|O3|Outcome|Part A: SAR 100 mg q2w|Sarilumab 100 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
1265064|NCT01061736|O2|Outcome|Part A: SAR 150 mg qw|Sarilumab 150 mg SC injection qw on top of MTX for 12 weeks.
1265065|NCT01061736|O1|Outcome|Part A: SAR 100 mg qw|Sarilumab 100 mg SC injection qw on top of MTX for 12 weeks.
1265066|NCT01061736|E13|Reported Event|Part B Sarilumab Rescue: Cohort 1(Selected Doses)+Cohort2|Part B participants exposed to sarilumab 150 mg q2w or 200 mg q2w or placebo q2w, without adequate response from Week 16, rescued with high dose of sarilumab (SAR 200 mg q2w) (mean exposure of 49 weeks from beginning of randomization to the end of rescue treatment).
1265067|NCT01061736|E12|Reported Event|Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2)|Part B participants exposed to placebo q2w on top of MTX (mean exposure of 40 weeks). 168 participants with inadequate response from Week 16 rescued with high dose of sarilumab (SAR 200 mg q2w) were not included. Excluded 1 participant randomized to placebo q2w who received sarilumab 200 mg q2w in error. He/she was considered in the 200 mg q2w treatment group for safety analysis.
1265068|NCT01061736|E11|Reported Event|Part B: SAR 200 mg q2w (Cohort 1[Selected Dose]+Cohort 2)|Part B participants exposed to sarilumab 200 mg q2w on top of MTX (mean exposure of 42 weeks). 55 participants with inadequate response from Week 16 rescued with high dose of sarilumab (SAR 200 mg q2w) were not included. Excluded 3 participants randomized to sarilumab 200 mg q2w who received at least one dose of sarilumab 150 mg q2w in error and included a participant randomized to placebo q2w who received sarilumab 200 mg q2w in error.
1265069|NCT01061736|E10|Reported Event|Part B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2)|Part B participants exposed to sarilumab 150 mg q2w on top of MTX (mean exposure of 42 weeks). 61 participants with inadequate response from Week 16 rescued with high dose of sarilumab (SAR 200 mg q2w) were not included. Included 3 participants randomized to sarilumab 200 mg q2w who received at least one dose of sarilumab 150 mg q2w in error.
1265070|NCT01061736|E9|Reported Event|Part B: SAR 100 mg q2w Cohort 1 (Non-selected Dose)|Part B participants exposed to sarilumab 100 mg q2w on top of MTX (mean exposure of 13 weeks). Included 1 participant who received sarilumab 100 mg q2w in error.
1265071|NCT01061736|E8|Reported Event|Part B: SAR 150 mg qw Cohort 1 (Non-selected Dose)|Part B participants exposed to sarilumab 150 mg qw on top of MTX (mean exposure of 12 weeks). Excluded 1 participant who received sarilumab 100 mg q2w in error. He/she was considered in the 100 mg q2w treatment group for safety analysis.
1265072|NCT01061736|E7|Reported Event|Part B: SAR 100 mg qw Cohort 1 (Non-selected Dose)|Part B participants exposed to sarilumab 100 mg qw on top of MTX (mean exposure of 10 weeks).
1265073|NCT01061736|E6|Reported Event|Part A: Placebo qw|Part A participants exposed to placebo on top of MTX (mean exposure of 12 weeks). Excluded 1 participant who received an erroneous IMP kit with sarilumab 150 mg q2w. He/she was considered in the 150 mg q2w treatment group for safety analysis.
1265074|NCT01061736|E5|Reported Event|Part A: SAR 200 mg q2w|Part A participants exposed to sarilumab 200 mg q2w on top of MTX (mean exposure of 11 weeks).
1265075|NCT01061736|E4|Reported Event|Part A: SAR 150 mg q2w|Part A participants exposed to sarilumab 150 mg q2w on top of MTX (mean exposure of 12 weeks). Included the participant randomized to placebo qw who received sarilumab 150 mg q2w in error.
1265076|NCT01061736|E3|Reported Event|Part A: SAR 100 mg q2w|Part A participants exposed to sarilumab 100 mg q2w on top of MTX (mean exposure of 11 weeks).
1265077|NCT01061736|E2|Reported Event|Part A: SAR 150 mg qw|Part A participants exposed to sarilumab 150 mg qw on top of MTX (mean exposure of 12 weeks).
1265078|NCT01061736|E1|Reported Event|Part A: SAR 100 mg qw|Part A participants exposed to sarilumab 100 mg qw on top of MTX (mean exposure of 10 weeks).
